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Lithium (PDF 2.4 MB) - Medical Marijuana ProCon.org
FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 100000145Report Type:Expedited (15-DaCompany Report #COU971063 Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Prothrombin Time Prolonged Health Professional Coumadin (Crystalline Warfarin Sodium) PS Lithium (Lithium) SS Digoxin (Digoxin) C Manufacturer Route ORAL UNKNOWN;ORAL UNKNOWN UNKNOWN ;UNKNOWN UNK/UNK Date:11/05/97ISR Number: 100000167Report Type:Expedited (15-DaCompany Report #97024471-1 Age:77 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 625 Initial or Prolonged MILLIGRAMS PT Report Source Product Role Blood Creatinine Foreign Lithium PS Increased Literature Confusional State Health Coordination Abnormal Drug Interaction Dysarthria Therapeutic Agent Toxicity Professional Diazepam Losartan Nicardipine Nifedipine Tamoxifen C C C C C Manufacturer Route ORAL DAILY Date:11/05/97ISR Number: 3008545-6Report Type:Periodic Age: Gender: I/FU:I Outcome Dose ORAL Company Report #M072320 PT Report Source Product Role Drug Interaction Health Glucophage PS Manufacturer Route Duration ORAL Hypoglycaemia Professional Lithium Procardia Elavil SS SS SS Date:11/07/97ISR Number: 100000186Report Type:Expedited (15-DaCompany Report #USA/97/01958/LEX Age:68 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 2 YR Initial or Prolonged Other Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 1 10:48 AM PT Report Source Product Role Delirium Health Clozaril (Clozapine) PS Overdose Professional Eskalith (Lithium Carbonate) Flagyl (Metronidazole) Erythromcin Amitriptyline Temazepam Wellbutrin (Amfebutamone) Synthroid (Levothyroxine Soduim) Pepcid SS C C C C C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/97ISR Number: 100000196Report Type:Expedited (15-DaCompany Report #D/97/03283/LEX Age:60 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 25 MG ORAL Initial or Prolonged 1350 MG ORAL Other 120 MG ORAL PT Report Source Product Role Cutaneous Vasculitis Foreign Leponex PS ORAL Dermatitis Health Quilonum Retard SS ORAL Vasculitis Necrotising Professional Dociton SS ORAL Melleretten C Date:11/10/97ISR Number: 3019695-2Report Type:Periodic Age:63 YR Gender:Male I/FU:I Outcome Dose Duration Other 400 MG PULSE Manufacturer Route Company Report #JAUSA-26957 PT Report Source Product Role Manufacturer Route Drug Level Above Health Sporanox PS Janssen ORAL Therapeutic Professional Lithium SS Tegretol C ORAL; COMMENTS: 200 MG BID, ONE WEEK ON, 300 MG 1 DAILY ORAL; COMMENTS: 600 MG TAKEN AT BEDTIME. Date:11/13/97ISR Number: 3005998-4Report Type:Direct Age:70 YR Gender:Male I/FU:I Company Report # ORAL Outcome Dose Duration Hospitalization 300 MG BID PO Initial or Prolonged (MANY PT Report Source Dehydration Product Role Lithium PS Lisinopril C Manufacturer Route ORAL Diarrhoea Dizziness YEARS) Drug Toxicity Gastritis Influenza Nausea Vision Blurred Vomiting Date:11/17/97ISR Number: 3005746-8Report Type:Direct Age:48 YR Gender: I/FU:I Outcome Dose Duration Hospitalization LONG TERM Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Hepatic Cirrhosis 22-Aug-2005 Page: 2 10:48 AM Report Source Product Role Lithium PS Hepatitis C Date:11/17/97ISR Number: 3005851-6Report Type:Direct Age:45 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged Company Report # PT Blood Creatinine Increased Condition Aggravated Confusional State Company Report # Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Level Above Therapeutic Drug Toxicity Dose Report Source Product Role Lithum PS Manufacturer Route Manufacturer Route Duration Renal Impairment Urinary Incontinence Date:11/18/97ISR Number: 3001367-1Report Type:Expedited (15-DaCompany Report #LIT/97/00315/MEL Age:30 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Anxiety Initial or Prolonged Confusional State 400 MG ORAL 3 DAY Dysarthria 1800 MG ORAL 6 DAY Gait Disturbance Insomnia Nausea Speech Disorder Tremor Report Source Product Role Literature Health Thioridazine Hydrochloride PS ORAL Professional Lithium Carbonate SS ORAL Date:11/18/97ISR Number: 3001547-5Report Type:Expedited (15-DaCompany Report #EL U830101 (83900792-1) Age:51 YR Gender:Male I/FU:F Outcome Dose Disability ORAL Other PT Report Source Product Role Burning Sensation Consumer Eskalith PS Thorazine (Chlorpromazine Hcl) SS Manufacturer Route Duration Disability Nephrogenic Diabetes Insipidus Polydipsia Polyuria Urine Abnormality Vomiting Date:11/18/97ISR Number: 3001563-3Report Type:Expedited (15-DaCompany Report #WAES 96096115 Age:77 YR Gender:Female I/FU:F ORAL Outcome Dose Duration Hospitalization 50 MG 5 WK Initial or Prolonged 629 MG Disability PT Report Source Product Role Manufacturer Route Blood Creatinine Foreign Cozaar PS ORAL Increased Literature Lithium Carbonate SS ORAL Confusional State Drug Interaction Drug Level Above Therapeutic Dysarthria Hypothyroidism Health Professional Nifedipine Tamoxifen Citrate C C Date:11/18/97ISR Number: 3001570-0Report Type:Expedited (15-DaCompany Report #97021136-1 Age:45 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization ORAL Initial or Prolonged 22-Aug-2005 Page: 3 10:48 AM PT Report Source Product Role Renal Failure Consumer Lithium PS Health Professional Haldol (Haloperidol) Depakote (Divalproex Sodium) C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/97ISR Number: 3001860-1Report Type:Expedited (15-DaCompany Report #8-97272-001C Age:67 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Confusional State Delirium Disorientation Foreign Study Trevilor Tablets (Venlafaxine Hydrochloride) PS ORAL Haldol SS ORAL Hypnorex (Lithium Carbonate) SS ORAL Tavor (Lorazepam) SS ORAL 37.5MG ONCE Disturbance In Attention DAILY Memory Impairment 1.5 MG DAILY 1200MG DAILY 3MG DAILY Date:11/20/97ISR Number: 3001875-3Report Type:Expedited (15-DaCompany Report #97025232-1 Age:82 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600MG Initial or Prolonged PT Report Source Product Role Manufacturer Apathy Foreign Lithium Carbonate PS Smithkline Beecham Blood Osmolarity Hypothyroidism Lethargy Nephrogenic Diabetes Insipidus Neurotoxicity Sedation Urinary Incontinence Literature Other Carbamazepine Fluvoxamine Haloperidol C C C Route Date:11/20/97ISR Number: 3002046-7Report Type:Expedited (15-DaCompany Report #D/97/03283/LEX Age:60 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 25 MG ORAL PT Report Source Product Role Vasculitis Necrotising Foreign Leponex PS Manufacturer Route ORAL Initial or Prolonged 1350 MG ORAL Other 120 MG ORAL Required 20 MG ORAL Intervention to Prevent Permanent Impairment/Damage Health Quilonum Retard SS ORAL Professional Dociton SS ORAL Melleretten SS ORAL Date:11/20/97ISR Number: 3006023-1Report Type:Direct Age:40 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600 MG AM & Initial or Prolonged HS Company Report # PT Report Source Product Role Bradycardia Health Lithium Carbonate PS Coordination Abnormal Professional Dysarthria Date:11/21/97ISR Number: 3002039-XReport Type:Expedited (15-DaCompany Report #9721825 Age:58 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 4 10:48 AM PT Asthenia Diabetes Insipidus Electrocardiogram Abnormal Mania Peripheral Motor Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuropathy Renal Failure Acute Dose ORAL Report Source Product Role Foreign Lithane PS Health Professional Herbal Medicine C Manufacturer Route Duration ORAL TAB Date:11/21/97ISR Number: 3002092-3Report Type:Expedited (15-DaCompany Report #LITH002970032 Age:77 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 625 MG PER Initial or Prolonged DAY PER PT Report Source Product Role Manufacturer Route Confusional State Foreign Lithium PS ORAL Coordination Abnormal Literature Losartan SS ORAL Drug Toxicity ORAL Dysarthria 50MG PER DAY PER ORAL Date:11/21/97ISR Number: 3002329-0Report Type:Expedited (15-DaCompany Report #9721825 Age:58 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Asthenia Foreign Lithane Tablets PS Diabetes Insipidus Electrocardiogram Abnormal Mania Peripheral Motor Neuropathy Renal Failure Acute Health Professional Herbal Medicine Levothyroxine C C Manufacturer Route ORAL Date:11/21/97ISR Number: 3006582-9Report Type:Direct Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 900 MG QD PT Company Report # Report Source Drug Interaction Product Role Lithium PS Aspirin Chlorpronaze Pepcid Hctz Quinspril Ofloxacin C C C C C C Manufacturer Route ORAL Drug Level Above PO;LONGTERM Therapeutic Drug Toxicity Hypotension Date:11/21/97ISR Number: 3006666-5Report Type:Direct Age:48 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 750 MG PO Q Initial or Prolonged AM 900 Q PM PT Drug Toxicity Company Report # Report Source Product Role Lithium PS Medication Error Date:12/02/97ISR Number: 3003744-1Report Type:Expedited (15-DaCompany Report #D/97/03283/LEX Age:60 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 5 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Required Intervention to Dose Duration Prevent Permanent 25 MG ORAL Impairment/Damage 1350 MG ORAL PT Report Source Product Role Manufacturer Route Aortic Valve Stenosis Health Leponex PS ORAL Dermatitis Professional Quilonum Retard SS ORAL Gangrene Melleretten SS ORAL Vasculitis Necrotising Dociton C 20 MG ORAL Date:12/04/97ISR Number: 3007144-XReport Type:Direct Age:65 YR Gender:Male I/FU:I Outcome Dose 300MG QAM Company Report # PT Report Source Product Role Drug Toxicity Health Lithium PS Therapeutic Agent Professional Manufacturer Route Manufacturer Route Duration & 600MG QHS Toxicity Date:12/04/97ISR Number: 3007234-1Report Type:Direct Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Other 300MG PO TID PT Company Report # Report Source Product Role Blood Pressure Decreased Lithium PS Confusional State Lisinopril SS Gait Disturbance Ibuprofen Albuterol Lorazepam C C C ORAL 10MG BID Date:12/05/97ISR Number: 3004407-9Report Type:Expedited (15-DaCompany Report #9725392 Age: Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization ORAL Initial or Prolonged ORAL Cardiac Disorder Foreign Zoloft PS ORAL Mania Health Lithium SS ORAL Muscle Rigidity Professional Date:12/08/97ISR Number: 3018299-5Report Type:Direct Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600 MG BID Initial or Prolonged PT Product Role Confusional State Lithium Carbonate PS Diarrhoea Drug Toxicity Dysarthria Hyperthyroidism Nausea Tremor Vomiting Weight Decreased Lopid Hydrochlorothiazide Metoprolol Risperidal Depakote Clonazepam C C C C C C Date:12/09/97ISR Number: 3007541-2Report Type:Direct Age:58 YR Gender:Male I/FU:I Outcome Life-Threatening Disability Congenital Anomaly Other 22-Aug-2005 Page: 6 10:48 AM Company Report # Report Source Company Report # Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent Dose Duration Impairment/Damage 1200 MG DAILY PT Report Source Product Role Manufacturer Drug Toxicity Health Lithobid PS Solvay Psychotic Disorder Professional Lithonate Synthroid SS C Route Date:12/10/97ISR Number: 3006129-7Report Type:Expedited (15-DaCompany Report #9725562 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged Other PT Report Source Product Role Accidental Overdose Foreign Lithane PS Convulsion Dyspepsia Pancreatic Carcinoma Consumer Manufacturer Route ORAL Date:12/12/97ISR Number: 3006734-8Report Type:Expedited (15-DaCompany Report #971204-008013330 Age:52 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 10 MG, QD, Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Dermatitis Exfoliative Foreign Serinase PS ORAL Litarex SS ORAL Lysantin C Tardive Dyskinesia ORAL Date:12/15/97ISR Number: 3007102-5Report Type:Expedited (15-DaCompany Report #9725928 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization ORAL PT Report Source Product Role Abnormal Behaviour Foreign Lithane PS Manufacturer Route ORAL Initial or Prolonged ORAL Arachnoiditis Consumer Eye Rolling Hallucination Headache Hypersomnia Muscle Twitching Pain Schizophrenia Suicide Attempt Tinnitus Date:12/16/97ISR Number: 3008218-XReport Type:Direct Age:57 YR Gender:Male I/FU:I Outcome Dose Duration Other 300 MG 1/ DAY 22-Aug-2005 Page: 7 10:48 AM Doxepin SS Benztropine C ORAL Company Report # PT Report Source Product Role Arrhythmia Health Lithium PS Dyspepsia Face Oedema Memory Impairment Muscle Twitching Tremor Vision Blurred Professional Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/17/97ISR Number: 3010885-1Report Type:Direct Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening ORALLY AT Hospitalization BEDTIME Initial or Prolonged 2 X DAILY Disability ORALLY PT Company Report # Report Source Aphasia Product Role Manufacturer Route Haloperidol PS Mcneil ORAL Lithium Carb SS Roxane ORAL Manufacturer Route Balance Disorder Cerebellar Ataxia Difficulty In Walking Movement Disorder Visual Disturbance Date:12/22/97ISR Number: 3015233-9Report Type:Expedited (15-DaCompany Report #9726288 Age:13 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 50 MG DAILY Initial or Prolonged ORAL PT Report Source Product Role Drug Interaction Foreign Zoloft PS Hyperhidrosis Health Serotonin Syndrome Professional Lithium SS Pericyazine Benzhexol C C ORAL 1500 MG TOTAL Therapeutic Agent TID Toxicity Tremor Vomiting Date:12/23/97ISR Number: 3011970-0Report Type:Expedited (15-DaCompany Report #LITH002970035 Age:45 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG. PER PT Report Source Product Role Manufacturer Route Eosinophilia Myalgia Syndrome Health Professional Lithonate PS Solvay Pharmaceuticals Usa ORAL Eosinophilic Pneumonia ORAL 10 YR Ativan Imuran Date:12/30/97ISR Number: 3015311-4Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600 MG QD Initial or Prolonged PO/ORAL Other PT C C Company Report # Report Source Electrocardiogram Qt Product Role Lithium PS N/A N/A SS C Manufacturer Route ORAL Prolonged Nausea Nervousness Tremor Date:12/31/97ISR Number: 3013432-3Report Type:Expedited (15-DaCompany Report #8-97357-001D Age:15 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 4 MG ORAL Initial or Prolonged 60 MG ORAL PT Report Source Product Role Accidental Overdose Foreign Trihexyphenidyl PS ORAL Blood Pressure Decreased Health Levomepromazine SS ORAL Coma Professional Lithium Carbonate SS ORAL 600 MG ORAL Hypothermia Miosis Neurological Symptom 22-Aug-2005 Page: 8 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/31/97ISR Number: 3013474-8Report Type:Expedited (15-DaCompany Report #8-97329-006T Age: Gender:Male I/FU:F Outcome Dose Duration Life-Threatening 50 MG DAILY Hospitalization ORAL Initial or Prolonged 15 MG DAILY Other ORAL PT Report Source Product Role Manufacturer Route Cardiac Failure Foreign Asendin PS ORAL Bromazepam SS ORAL Lithium Carbonate SS Maprotiline Hydrochloride SS Sodium Valproate SS Health Professional 600 MG DAILY ORAL 30 MG DAILY ORAL 100 MG ; DAILY ; ORAL Date:12/31/97ISR Number: 3069833-0Report Type:Periodic Age:69 YR Gender:Female I/FU:I Outcome Dose Other 250.00 MG Company Report #9705125 PT Report Source Product Role Manufacturer Route Confusional State Health Zithromax PS ORAL Drug Interaction Professional Drug Level Above Company Therapeutic Representative Lithium SS ORAL Duration TOTAL:DAILY:O RAL 1.00 GRAM TOTAL:DAILY:O RAL Date:01/05/98ISR Number: 3016361-4Report Type:Expedited (15-DaCompany Report #9711748 Age:74 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 1200.00MG Hospitalization TOTAL:DAILY:O Initial or Prolonged RAL Other PT Report Source Product Role Amnesia Foreign Lithane PS Blood Glucose Increased Consumer Amitryptyline C Manufacturer Route ORAL Coma Drug Ineffective Eczema Lethargy Memory Impairment Muscle Twitching Polyuria Thirst Tremor Date:01/08/98ISR Number: 3017427-5Report Type:Expedited (15-DaCompany Report #97030338-1 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged Other 22-Aug-2005 Page: 9 10:48 AM PT Report Source Product Role Manufacturer Route Blood Creatinine Health Eskalith PS Smithkline Beecham ORAL Increased Dehydration Hypotension Neuroleptic Malignant Syndrome Pyrexia Renal Failure Acute Urinary Tract Infection Professional Clozaril Moban C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/98ISR Number: 3087373-XReport Type:Periodic Age:35 YR Gender:Male I/FU:I Outcome Dose Other 10.00 MG Company Report #9725041 PT Report Source Product Role Manufacturer Route Drug Toxicity Health Zyrtec PS ORAL Hyperhidrosis Professional Lithium Erythromycin Ointment Restoril Akineton Haldol Deconoate Elavil Anaprox Ds Beconase SS ORAL Duration TOTAL:DAILY Nervousness Tremor C C C C C C C Date:01/09/98ISR Number: 3016776-4Report Type:Expedited (15-DaCompany Report #LBID002970039 Age:58 YR Gender:Male I/FU:I Outcome Dose Duration Disability 1200 MG, PER PT Report Source Product Role Confusional State Other Lithobid PS Elavil Synthroid Xanax C C C Manufacturer Route ORAL Dementia ORAL Disability Emotional Disorder Gait Disturbance Date:01/12/98ISR Number: 3016078-6Report Type:Expedited (15-DaCompany Report #971211-008013454 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Atrial Septal Defect INTRA-UTERINE 100 MG, Initial or Prolonged Complications Of Maternal 1X/3WK, Exposure To Therapeutic INTRAUTERINE 49 DAY Report Source Product Role Foreign Haldol PS Health Professional Manufacturer Route INTRA-UTERINE INTRAUTERINE Drugs 450 MG, QD, Foetal Growth Retardation 49 DAY Neonatal Aspiration Patent Ductus Arteriosus Lithium Acetate SS Date:01/12/98ISR Number: 3016611-4Report Type:Expedited (15-DaCompany Report #EL U830101 (83900792-1) Age:51 YR Gender:Male I/FU:F Outcome Dose Disability Other ORAL PT Report Source Product Role Manufacturer Route Burning Sensation Dizziness Consumer Health Eskalith PS Smithkline Beecham Pharm ORAL Headache Professional Thorazine SS Lorazepam Zantac Serzone C C C Duration 16 YR 100 Nephrogenic Diabetes MILLIGRAMS Insipidus Nocturia Polydipsia Polydipsia Psychogenic Polyuria Renal Disorder Urine Abnormality Vomiting Weight Increased 22-Aug-2005 Page: 10 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/98ISR Number: 3015473-9Report Type:Expedited (15-DaCompany Report #98000342-1 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 450 ML/ 2.0 Initial or Prolonged DAILY ORAL/20 PT Report Source Product Role Manufacturer Route Blood Creatinine Health Eskalith PS Smithkline Beecham ORAL Increased Professional Eskalith SS Smithkline Beecham ORAL Product Role Manufacturer Route Lithium PS Manufacturer Route Hypertension YEARS 20 YR Tremor 2.0 DAILY/ ORAL Date:01/13/98ISR Number: 3095823-8Report Type:Direct Age:43 YR Gender:Female I/FU:I Outcome Dose PT Company Report # Report Source Duration Asthenia 200MG TID Blood Creatine Phosphokinase Increased Convulsion Difficulty In Walking Dizziness Drug Toxicity Hypertension Neuroleptic Malignant Syndrome Tremor Date:01/14/98ISR Number: 3016777-6Report Type:Expedited (15-DaCompany Report #LITH002970034 Age:58 YR Gender:Male I/FU:I Outcome Dose Disability PER ORAL PT Report Source Product Role Balance Disorder Other Lithonate PS Elavil Synthroid C C Duration Confusional State Disorientation ORAL Emotional Disorder Visual Disturbance Date:01/15/98ISR Number: 3018405-2Report Type:Direct Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 900MG PO BID Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT 22-Aug-2005 Page: 11 10:48 AM C Company Report # Report Source Coma Product Role Lithium Carbonate PS Manufacturer Route Manufacturer Route Drug Level Above Therapeutic Lethargy Mental Impairment Oedema Peripheral Date:01/15/98ISR Number: 3018422-2Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 15MG QD PO Required 600 MG BID Intervention to Prevent Permanent Impairment/Damage Xanax PT Company Report # Report Source Product Role Asthenia Olanzapine PS Lethargy Lithium SS Deponovera Bentotropine Prophxdol Nifedipine Phetz C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metzltestzolerod Malox Tylenol Trazadae Vitamins E Halolol Date:01/15/98ISR Number: 3018670-1Report Type:Direct Age:29 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Outcome Dose Duration Hospitalization 300 MG BID PO Initial or Prolonged PT Report Source Product Role Imitrex Nardil Lithobid Epinephrine Benadryl PS SS SS C C Manufacturer Route Manufacturer Route Company Report # Report Source Decreased Activity Product Role Lithium PS ORAL Poverty Of Speech Therapeutic Agent Toxicity Date:01/21/98ISR Number: 3018900-6Report Type:Direct Age:64 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 300MG BID 12 YR Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Company Report # Cyanosis Drug Interaction Dyspnoea Pharyngeal Oedema Date:01/20/98ISR Number: 3018830-XReport Type:Direct Age:51 YR Gender:Female I/FU:I C C C C C C PT Company Report # Report Source Product Role Coma Lithionate PS Drug Toxicity Enalapril Levothyroxine C C Manufacturer Route Impairment/Damage Date:01/22/98ISR Number: 3017818-2Report Type:Direct Age:66 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG BID Initial or Prolonged 150HS LONG PT Depressed Level Of Company Report # Report Source Product Role Lithium PS Perphenzxime Valproic Acid C C Consciousness Mental Impairment TERM Date:01/26/98ISR Number: 3019308-XReport Type:Expedited (15-DaCompany Report #9800488 Age:19 YR Gender:Male I/FU:I Outcome Death Hospitalization Initial or Prolonged 22-Aug-2005 Page: 12 10:48 AM PT Abdominal Pain Bipolar Disorder Blood Lactate Dehydrogenase Decreased Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Blood Sodium Decreased Completed Suicide Crystalluria Report Source Product Role Cystitis Health Zoloft PS ORAL Depression Professional Xanax Lithium SS SS ORAL Risperidone SS ORAL Cogentin Ativan Restoril Haldol Decanoate Haldol C C C C C Manufacturer Route Duration 50.00 MG TOTAL:DAILY:O Drug Interaction RAL Potentiation Dyskinesia 900.00 MG Electroencephalogram TOTAL:TID:ORA Abnormal L Eye Movement Disorder 9.00 MG Haematuria TOTAL:TID:ORA Intentional Misuse L Ketonuria Nervous System Disorder Urinary Tract Infection Urine Analysis Abnormal Date:01/27/98ISR Number: 3021391-2Report Type:Direct Age:61 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Confusional State Coordination Abnormal Company Report # Report Source Product Role Lithium Atenolol Hctz Haloperidol Risperidone Benztropine PS C C C C C Date:01/29/98ISR Number: 3021790-9Report Type:Expedited (15-DaCompany Report #B0052903 Age:36 YR Gender:Male I/FU:I Manufacturer Route Outcome Dose Duration Hospitalization PER DAY/ ORAL Initial or Prolonged ORAL PT Report Source Product Role Hepatic Enzyme Increased Foreign Epivir PS ORAL Thioridazine SS ORAL Lithium Salt SS ORAL Indianavir SS ORAL Stavudine SS ORAL Hepatitis Manufacturer Route ORAL PER DAY / ORAL PER DAY/ ORAL Date:01/29/98ISR Number: 3111907-XReport Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose Other ORAL PT Report Source Product Role Amnesia Consumer Redux PS Eskalith SS 14 YR Confusional State Thinking Abnormal Date:01/30/98ISR Number: 3021558-3Report Type:Expedited (15-DaCompany Report #EL U830101-(8900792-1) Age:51 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged Disability 22-Aug-2005 Page: 13 Manufacturer Route Duration Anxiety 600MG Company Report #8-97299-122K 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Dose PT Report Source Product Role Manufacturer Route Burn Oesophageal Dizziness Consumer Health Eskalith PS Smithkline Beecham Pharm ORAL Headache Professional Duration 150 MILLIGRAMS Nephrogenic Diabetes ORAL DAILY Insipidus Thorazine SS Lorazepam Zantac Serzone C C C ORAL 500 Nocturia MILLIGRAMS Pollakiuria 1.0 DAILY Polydipsia ORAL Polyuria Renal Impairment Sedation Urine Analysis Abnormal Vomiting Weight Increased Date:02/02/98ISR Number: 3022576-1Report Type:Expedited (15-DaCompany Report #98000342-1 Age:41 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 450 Initial or Prolonged MILLIGRAMS PT Report Source Product Role Manufacturer Route Blood Creatinine Health Eskalith PS Smithkline Beecham ORAL Increased Professional Fluphenazine Carbamazepine C C Blood Thyroid Stimulating 2.0 DAILY Hormone Increased ORAL; 300 Diarrhoea MILLIGRAMS 19 DAY Drug Level Above Therapeutic Drug Toxicity Hypertension Hypothyroidism Mania Muscle Rigidity Tremor Urinary Incontinence Date:02/03/98ISR Number: 3028985-9Report Type:Direct Age:58 YR Gender:Male I/FU:I Outcome Dose Duration Disability Other Required Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Mental Disorder Product Role Lithonate PS Manufacturer Route Manufacturer Route Date:02/10/98ISR Number: 3027038-3Report Type:Expedited (15-DaCompany Report #LBID002980003 Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged 22-Aug-2005 Page: 14 10:48 AM PT Report Source Product Role Blood Potassium Decreased Consumer Lithobid PS Prozac C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/10/98ISR Number: 3027041-3Report Type:Expedited (15-DaCompany Report #LBID002980004 Age:48 YR Gender: I/FU:I Outcome Dose Duration Death PER ORAL YR Hospitalization 15 MG, PER Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Confusional State Health Lithobid PS ORAL Delirium Professional Haldol SS ORAL Neuroleptic Malignant Syndrome Pyrexia Tachycardia Date:02/10/98ISR Number: 3027145-5Report Type:Expedited (15-DaCompany Report #LITH000980001 Age:56 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization PER ORAL Initial or Prolonged PT Report Source Product Role Blood Parathyroid Hormone Literature Lithium Carbonate PS Thiothixene C Increased Bradycardia Cardiovascular Disorder Dermatitis Drug Level Above Therapeutic Hypercalcaemia Hypertension Hypomania Parathyroid Disorder Manufacturer Route ORAL Date:02/17/98ISR Number: 3029847-3Report Type:Expedited (15-DaCompany Report #8-98040-037D Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 900MG ORAL Initial or Prolonged 90 ORAL PT Report Source Product Role Manufacturer Route Hypotension Foreign Effexor PS ORAL Overdose Health Diazepam SS ORAL Other 6 ORAL Sedation Professional Estrogen SS ORAL Lithium SS ORAL Procyclidine SS ORAL 3.6 G ORAL 90 MG ORAL Date:02/17/98ISR Number: 3030593-0Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Drug Level Above Therapeutic Intentional Misuse Date:02/17/98ISR Number: 3030662-5Report Type:Direct Age:39 YR Gender:Female I/FU:I Outcome Dose Duration Congenital Anomaly Company Report # PT Product Role Lithium Carbonate Haloperidol Trazodone Benztropine PS C C C 10:48 AM Route Manufacturer Route Company Report # Report Source Product Role Abortion Spontaneous Complications Of Maternal Lithium Trilafon PS SS Exposure To Therapeutic Drugs Foetal Disorder Klonipin Zoloft Atenolol C C C 8 MG BID 22-Aug-2005 Page: 15 Manufacturer FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/98ISR Number: 3247642-7Report Type:Periodic Age:41 YR Gender:Male I/FU:I Outcome Dose Other 50 MG TWICE Company Report #8-97357-005S PT Report Source Product Role Drug Interaction Consumer Duract PS Lithium SS Clonidine Patch C Manufacturer Route Duration ORAL Tremor DAILY ORAL 1500 MG DAILY Date:02/18/98ISR Number: 3031911-XReport Type:Direct Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization PO 20 YR Initial or Prolonged PT Company Report # Report Source Decreased Appetite Product Role Lithium PS Manufacturer Route ORAL Mental Disorder Nausea Vomiting Date:02/19/98ISR Number: 3032009-7Report Type:Expedited (15-DaCompany Report #93968 Age:40 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 50.0000 MG Initial or Prolonged DAILY ORAL PT Report Source Product Role Coma Health Posicor PS ORAL Convulsion Professional Lithium SS ORAL Cogentin Risperdal C C Drug Toxicity 900.0000 MG Electrocardiogram Qt DAILY ORAL Prolonged Manufacturer Route Date:02/19/98ISR Number: 3032300-4Report Type:Expedited (15-DaCompany Report #8-98040-023D Age:45 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 750 MG ORAL Initial or Prolonged Other 19.2 G PT Report Source Product Role Dysarthria Foreign Efexor Tablets PS Overdose Sedation Health Professional Etoh Lithium SS SS Thyroxine SS Manufacturer Route ORAL 125 MCG Date:02/20/98ISR Number: 3032159-5Report Type:Expedited (15-DaCompany Report #8-98040-003D Age:36 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged ORAL Other 22-Aug-2005 Page: 16 10:48 AM PT Report Source Product Role Manufacturer Route Coma Foreign Efexor PS ORAL Dry Mouth Health Alcohol SS ORAL Hypotension Overdose Tachycardia Professional Buprenorphine Lithium Paracetamol Thioridazine ... ... ... ... ... SS SS SS SS C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/98ISR Number: 3032982-7Report Type:Expedited (15-DaCompany Report #EL U830101 (83900792-1) Age:51 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 600 Disability MILLIGRAMS PT Report Source Product Role Manufacturer Route Aggression Blood Creatinine Consumer Health Eskalith PS Smithkline Beecham Pharm ORAL Increased Professional Chest Pain 3.0 DAILY Dermatitis ORAL/1100 Diarrhoea MILLIGRAMS 217 DAY Dizziness Thorazine SS ORAL Thorazine SS ORAL Eskalith SS 200 Erectile Dysfunction MILLIGRAMS Flushing 3.0 DAILY Hallucinations, Mixed ORAL 119 DAY Headache 100 Hostility MILLIGRAMS Nephrogenic Diabetes 1.0 DAILY Insipidus ORAL/75 Nocturia MILLIGRAMS 14 DAY Oesophagitis Paranoia 1500 Polydipsia MILLIGRAMS Polydipsia Psychogenic ORAL/500 Polyuria MILLIGRAMS Renal Disorder 1.0 DAILY Schizophrenia Sedation Lorazepam Serzone C C Smithline Beecham Pharm ORAL Suicidal Ideation Thirst Throat Irritation Urine Abnormality Vomiting Weight Increased Imipramine Klonopin C C Date:02/23/98ISR Number: 3036317-5Report Type:Expedited (15-DaCompany Report #8-98044-005D Age:38 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Drug Interaction Potentiation Loss Of Consciousness Mydriasis Overdose Vomiting Foreign Health Professional Efexor Chlordiazepoxide Lithium Paracetamol Promethazine Thiordidazine PS SS SS SS SS SS Manufacturer Route ORAL Date:02/23/98ISR Number: 3036440-5Report Type:Expedited (15-DaCompany Report #9802883 Age:75 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 100.00MG Initial or Prolonged TOTAL DAILY PT Report Source Product Role Manufacturer Route Confusional State Foreign Zoloft PS ORAL Disturbance In Attention Health Drug Interaction Professional Therapeutic Agent Company Lithium SS ORAL Toxicity Representative ORAL 84.00MG TOTAL BID ORAL Other 22-Aug-2005 Page: 17 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/98ISR Number: 3036667-2Report Type:Direct Age:53 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Atrioventricular Block 450MG Q AM Initial or Prolonged First Degree 900MG Q PM 3 MON Depression Diarrhoea Drug Toxicity Suicidal Ideation Date:02/23/98ISR Number: 3036817-8Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Disability 300 MG PO PT Company Report # Report Source Product Role Lithium PS Olanzapine Asa Ec Erythromycin C C C Manufacturer Route Manufacturer Route Company Report # Report Source Product Role Lithium PS Carbamazepine C Duration Abdominal Pain ORAL Anorexia QD Confusional State Drug Toxicity Dysarthria Nausea Tremor Date:02/23/98ISR Number: 3036824-5Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600 MG PO BID Initial or Prolonged LESS THAN ONE YR 1 YR PT Drug Toxicity Sedation Company Report # Report Source Product Role Lithium PS Manufacturer Route ORAL Date:02/23/98ISR Number: 3037819-8Report Type:Expedited (15-DaCompany Report #93968 Age:40 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 50.00 MG Initial or Prolonged DAILY ORAL PT Report Source Product Role Coma Health Posicor PS ORAL Convulsion Professional Lithium SS ORAL Cogentin Risperdal C C Electrocardiogram Qt Manufacturer Route 900.00 MG Prolonged DAILY ORAL Therapeutic Agent Toxicity Ventricular Hypertrophy Date:02/23/98ISR Number: 3037910-6Report Type:Expedited (15-DaCompany Report #WAES 98020028 Age:60 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 10 Initial or Prolonged MG/DAILY/PO UNKNOWN PT Report Source Product Role Drug Toxicity Health Fosamax PS Hypoglycaemia Professional Lithiumco3 SS Artane Buspar Depakote Haldol Os-Cal Aspirin Digoxin C C C C C C C Syncope 1500-1800 MG/DAILY 22-Aug-2005 Page: 18 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Docusate Sodium Lithium Carbonate Vitamin E Date:02/23/98ISR Number: 3121212-3Report Type:Periodic Age:30 YR Gender:Male I/FU:I Outcome Dose Other 30.00 MG C C C Company Report #9715698 PT Report Source Product Role Confusional State Literature Procardia PS Coordination Abnormal Health Drug Level Above Professional Lithium SS Haloperidol SS Clonazepam SS Manufacturer Route Duration ORAL TOTAL:DAILY 1500.00 MG Therapeutic TOTAL DAILY Dysarthria 20.00 MG Gait Disturbance TOTAL:DAILY Sedation DAILY Tremor Date:02/25/98ISR Number: 3038292-6Report Type:Direct Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 200 MG Q AM + Initial or Prolonged HS, 100 MG Q Required H PR Intervention to 600 MG Q AM + Prevent Permanent HS &300 Impairment/Damage PT Coordination Abnormal Company Report # Report Source Product Role Phenytion PS Lithium SS Sertraline Lisinopril C C Nystagmus Manufacturer Route Date:03/02/98ISR Number: 3128640-0Report Type:Periodic Age:22 YR Gender:Female I/FU:I Outcome Dose Other ORAL Company Report #9721690 PT Report Source Product Role Manufacturer Route Anorexia Consumer Zoloft PS ORAL Depression Antibiotic SS ORAL Hostility Lithium SS ORAL Neurosis Redux SS ORAL Weight Increased Ritalin Tegretol Serzone C C C Duration ORAL 1200 MG TOTAL Increased Appetite BID ORAL ORAL Date:03/02/98ISR Number: 3129649-3Report Type:Periodic Age:68 YR Gender:Female I/FU:I Outcome Dose Duration Other 50.00MG TOTAL Company Report #9713237 PT Report Source Product Role Manufacturer Route Drug Interaction Health Zoloft PS ORAL Nausea Professional Lithium SS ORAL DAILY ORAL Sedation 600.00MG TOTAL BID ORAL 22-Aug-2005 Page: 19 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/98ISR Number: 3130209-9Report Type:Periodic Age:83 YR Gender:Female I/FU:I Outcome Dose Duration Other 200 MG TOTAL Company Report #9618742 PT Report Source Product Role Manufacturer Route Drug Ineffective Health Zoloft PS ORAL Drug Level Below Professional Lithium SS ORAL Aminophylline Atrovent Proventil Vancenase Synthroid C C C C C DAILY ORAL Therapeutic 450 MG TOTAL Tremor ORAL Date:03/02/98ISR Number: 3130728-5Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 75.00 MG Initial or Prolonged TOTAL;DAILY;O Company Report #9703016 PT Report Source Product Role Manufacturer Route Mania Consumer Zoloft Tablets PS ORAL Tremor Health Mellaril SS ORAL Lithium Klonopin Restoril SS C C Professional RAL ORAL Date:03/02/98ISR Number: 3130964-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other ORAL Company Report #9724608 PT Report Source Product Role Depression Consumer Zoloft PS Manufacturer Route Duration ORAL Hangover Lithium SS ORAL DAILY: ORAL Mania Date:03/02/98ISR Number: 3141572-7Report Type:Periodic Age:36 YR Gender:Male I/FU:I Outcome Dose Other 150.00 MG Company Report #9722228 PT Report Source Product Role Manufacturer Route Depression Consumer Zoloft PS ORAL Lithium SS ORAL Duration Ejaculation Disorder TOTAL:DAILY:O Erectile Dysfunction RAL Libido Decreased ORAL Personality Disorder Date:03/02/98ISR Number: 3145014-7Report Type:Periodic Age:19 YR Gender:Male I/FU:I Outcome Dose Other 100.00 MG Company Report #9703873 PT Report Source Product Role Manufacturer Route Confusional State Health Zoloft PS ORAL Delirium Professional Lithium SS ORAL Monosodium Glutamate SS ORAL Duration TOTAL: DAILY: Drug Interaction ORAL Vomiting 600.00 MG TOTAL: DAILY: ORAL ORAL 22-Aug-2005 Page: 20 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/98ISR Number: 3145032-9Report Type:Periodic Age:20 YR Gender:Male I/FU:I Outcome Dose Other 100.00 MG Company Report #9703875 PT Report Source Product Role Manufacturer Route Confusional State Health Zoloft PS ORAL Delirium Professional Monosodium Glutamate SS ORAL Lithium SS ORAL Duration TOTAL: DAILY: Drug Interaction ORAL ORAL 600.00 MG TOTAL: DAILY: ORAL Date:03/02/98ISR Number: 3147552-XReport Type:Periodic Age:38 YR Gender:Male I/FU:I Outcome Dose Other TID ORAL Company Report #9709868 PT Report Source Product Role Manufacturer Route Chills Consumer Zoloft PS ORAL Confusional State Health Redux SS ORAL Coordination Abnormal Professional Lithium SS ORAL Eskalith Glucophage Glucotrol Xl C C C Duration 30 MG TOTAL BID ORAL Depression 300 MG TOTAL DAILY ORAL Date:03/02/98ISR Number: 3149180-9Report Type:Periodic Age:19 YR Gender:Male I/FU:I Company Report #9708927 Outcome Dose Other DAILY; ORAL PT Report Source Product Role Manufacturer Route Confusional State Health Zoloft Tablets PS ORAL Vomiting Professional Lithonate SS ORAL Monosodium Glutamate SS ORAL Duration DAILY; ORAL ORAL Date:03/04/98ISR Number: 3040500-2Report Type:Expedited (15-DaCompany Report #1998004061-1 Age:56 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 900 MG Initial or Prolonged PT Report Source Product Role Manufacturer Anxiety Literature Lithuim PS Smithkline Beecham Flupenthixol Haloperidol Perazine C C C Aphasia Apraxia Chills Depression Disorientation Elevated Mood Mania Muscle Rigidity Parkinson'S Disease Reflexes Abnormal Restlessness Sleep Disorder Tremor Date:03/04/98ISR Number: 3128786-7Report Type:Periodic Age:57 YR Gender:Male I/FU:I Outcome Other 22-Aug-2005 Page: 21 PT Drug Interaction Drug Level Below 10:48 AM Company Report #9726378 Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Hostility Mania Dose Report Source Product Role Manufacturer Route Health Cardura PS ORAL Professional Lithium SS ORAL Duration DAILY ORAL 1350.00MG TOTAL TID ORAL Date:03/04/98ISR Number: 3131235-6Report Type:Periodic Age:57 YR Gender:Male I/FU:I Outcome Dose Other DAILY; ORAL Company Report #9726378 PT Report Source Product Role Manufacturer Route Drug Interaction Health Cardura PS ORAL Drug Level Below Professional Lithium SS ORAL Duration 1350.00 MG Therapeutic TOTAL; TID; Hostility ORAL Mania Date:03/06/98ISR Number: 3048757-9Report Type:Expedited (15-DaCompany Report #9803770 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Confusional State Foreign Minipress Xl PS Dysarthria Sinus Bradycardia Therapeutic Agent Toxicity Tremor Health Professional Lithium Carbonate Haloperidol Clobazam Carbamazepine Disulfirame SS C C C C Manufacturer Route ORAL Date:03/06/98ISR Number: 3139756-7Report Type:Periodic Age:43 YR Gender:Female I/FU:I Outcome Dose Duration Other 37.5MG THREE Company Report #8-97162-003B PT Report Source Product Role Manufacturer Route Abnormal Dreams Health Effexor PS ORAL Agitation Professional Coordination Abnormal Drug Withdrawal Syndrome Codeine Cough Syrup Fastin SS SS ORAL Gait Disturbance Lithium SS ORAL Pondimin Tablets SS ORAL Sinequan C TIMES DAILY Amnesia ORAL,75MG Anxiety TWICE Confusional State DAILY,75MG ORAL 900MG DAILY Pharyngitis ORAL Speech Disorder ORAL Date:03/06/98ISR Number: 3145898-2Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG THREE Initial or Prolonged TIMES DAILY Company Report #8-97065-002J PT Report Source Product Role Manufacturer Route Agitation Health Effexor PS ORAL Hostility Professional Cogentin SS ORAL Lithium SS ORAL Psychotic Disorder ORAL/ 300 MG FOUR TIMES DAILY / 100 0.5 MG AT BEDTIME ORAL 600 MG AT 22-Aug-2005 Page: 22 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report BEDTIME ORAL Tranxene SS Trilafon SS Cogentin Lithium Tranxene Trilafon C C C C 75 MG THREE TIMES DAILY ORAL 2 MG AT BEDTIME ORAL Date:03/06/98ISR Number: 3146564-XReport Type:Periodic Age:30 YR Gender:Female I/FU:F Outcome Dose Other ORAL 2 Company Report #8-96346-001J PT Report Source Product Role Condition Aggravated Health Effexor PS Depression Professional Lithium SS Lithium C Manufacturer Route Duration 2 ORAL MON MON Ecchymosis Menorrhagia Date:03/09/98ISR Number: 3051619-4Report Type:Expedited (15-DaCompany Report #9802883 Age:75 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 100.00 MG Initial or Prolonged TOTAL:DAILY:O PT Report Source Product Role Manufacturer Route Bipolar I Disorder Foreign Zoloft PS ORAL Blood Thyroid Stimulating Health Hormone Decreased Professional Confusional State Company Lithium SS ORAL Disturbance In Attention Representative RAL 84.00 MG TOTAL:BID:ORA Drug Interaction L Potentiation Drug Level Above Therapeutic Malaise Urinary Tract Infection Date:03/09/98ISR Number: 3051623-6Report Type:Expedited (15-DaCompany Report #9802883 Age:75 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 100.00 MG Initial or Prolonged TOTAL:DAILY:O PT Report Source Product Role Manufacturer Route Antidepressant Drug Level Foreign Zoloft PS ORAL Above Therapeutic Health Confusional State Professional Disturbance In Attention Company Lithium SS ORAL Drug Interaction Representative RAL 84.00 MG TOTAL:BID:ORA Potentiation L Date:03/10/98ISR Number: 3049180-3Report Type:Direct Age:58 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600MG BID PO Initial or Prolonged 22-Aug-2005 Page: 23 10:48 AM PT Company Report # Report Source Product Role Dysarthria Lithium PS Feeling Jittery Overdose Tremor Lithium Phenytoin Lorazepam C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/10/98ISR Number: 3054453-4Report Type:Expedited (15-DaCompany Report #8-98054-002D Age:46 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization UNKNOWN Initial or Prolonged AMOUNT ORAL PT Report Source Product Role Intentional Misuse Foreign Efexor PS Loss Of Consciousness Health Diazepam Lithium Moclobemine Procyclidine N/A SS SS SS SS C Professional Date:03/12/98ISR Number: 3058532-7Report Type:Direct Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Death ORALLY Life-Threatening PT Manufacturer Route ORAL Company Report # Report Source Product Role Abdominal Distension Lithium PS Abdominal Pain Anorexia Antinuclear Antibody Positive Aspiration Bipolar Disorder Blood Creatinine Increased Blood Culture Positive Blood Pressure Decreased Constipation Convulsion Dehydration Depressed Level Of Consciousness Dermatitis Diabetes Mellitus Eye Disorder Haemorrhage Hepatomegaly Large Intestine Perforation Lethargy Metronidazole Timentin Methylprdenisolone Diazepam Phenytoin C C C C C Manufacturer Route ORAL Lupus Encephalitis Metabolic Acidosis Nausea Nephrosclerosis Oliguria Pelvic Congestion Peritoneal Haemorrhage Petechiae Pulmonary Oedema Pyrexia Renal Failure Acute Sluggishness Therapeutic Agent Toxicity Ventricular Hypertrophy Vomiting 22-Aug-2005 Page: 24 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3135135-7Report Type:Periodic Age:23 YR Gender:Male I/FU:I Outcome Dose Other Company Report #JAUSA-27988 PT Report Source Product Role Manufacturer Route Confusional State Health Professional Risperdal (Risperidone), Janssen, Tablet PS Janssen ORAL Lithium SS Duration 2 MG DAILY ORAL Date:03/12/98ISR Number: 3135137-0Report Type:Periodic Age:20 YR Gender:Female I/FU:I Outcome Dose Other Company Report #JAUSA-27989 PT Report Source Product Role Manufacturer Route Confusional State Extrapyramidal Disorder Sedation Health Professional Risperdal (Risperidone), Janssen, Tablet PS Janssen ORAL Lithium (Lithium) SS Duration 1.5 MG DAILY ORAL Date:03/12/98ISR Number: 3139764-6Report Type:Periodic Age:12 YR Gender:Male I/FU:I Outcome Dose Other Company Report #JAUSA-28930 PT Report Source Product Role Manufacturer Route Albuminuria Haematuria Polyuria Health Professional Risperdal (Risperidone), Janssen, Tablet PS Janssen ORAL Lithium (Lithium) Tablet SS Duration 8 MG DAILY Thirst ORAL -, ORAL,STOPPED ORAL DUE TO POLYURIA, POLYDIPSIA Depakote Ritalin Zoloft Date:03/19/98ISR Number: 3057674-XReport Type:Direct Age:41 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600 MG Q AM; Initial or Prolonged 900 MG Q HS; PT Asthenia C C C Company Report # Report Source Product Role Lithium PS Salicylates Pru Risperidone C C Visual Disturbance THERAPY: LONG TERM Date:03/24/98ISR Number: 3059467-6Report Type:Expedited (15-DaCompany Report #96115 Age:36 YR Gender:Female I/FU:I Outcome Death 22-Aug-2005 Page: 25 PT Agitation Blood Thyroid Stimulating Hormone Increased Bundle Branch Block Right Drug Level Above 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Electrocardiogram Normal Dose Report Source Product Role Manufacturer Route Foreign Rivotril PS ORAL Teralithe SS ORAL Depakine Chrono SS ORAL Atarax SS ORAL Valium Nozinan C C Duration 8.000 MG Other DAILY ORAL 800.0000 MG DAILY ORAL 500.0000MG DAILY ORAL 300.0000MG DAILY ORAL Date:03/24/98ISR Number: 3059577-3Report Type:Expedited (15-DaCompany Report #94721 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization 40.0000 MG Initial or Prolonged 2.0 X PER DAY PT Report Source Product Role Manufacturer Route Abnormal Behaviour Health Accutane PS ORAL Hallucination Professional Lithium SS ORAL Mania ORAL 49 DAY Psychotic Disorder 1.0000 DOSE Self Mutilation FORM 1.0 X PER DAY ORAL Date:03/25/98ISR Number: 3060427-XReport Type:Expedited (15-DaCompany Report #LITH002980004 Age:45 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 900 MG, PER Initial or Prolonged ORAL PT Report Source Product Role Abdominal Distension Consumer Lithonate PS Morphine C Date:03/25/98ISR Number: 3060546-8Report Type:Direct Age:49 YR Gender:Female I/FU:I 22-Aug-2005 Page: 26 10:48 AM Route ORAL Blood Pressure Decreased Cardiac Failure Congestive Confusional State Delirium Diarrhoea Drug Level Above Therapeutic Dyspnoea Hallucination, Visual Oedema Peripheral Oxygen Saturation Decreased Pneumonia Vomiting Weight Increased Outcome Dose Duration Hospitalization 300 MG BID PO Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Manufacturer PT Diabetes Insipidus Hypernatraemia Company Report # Report Source Product Role Lithium Carbonate PS Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/98ISR Number: 3132828-2Report Type:Periodic Age:39 YR Gender:Male I/FU:I Outcome Dose Other 400 MG BID; Company Report #8-98020-008N PT Report Source Product Role Drug Specific Antibody Consumer Lodine PS Dayquil Depakote Imipramine Lithium Pseudophedrine Promethazine With Codeine E.E.S. SS SS SS SS Manufacturer Route Duration ORAL Present PRN SS C Date:03/26/98ISR Number: 3059262-8Report Type:Expedited (15-DaCompany Report #1998007501-1 Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300 Initial or Prolonged MILLIGRAMS PT Report Source Product Role Manufacturer Cardiac Failure Health Eskalith PS Smithkline Beecham Drug Level Above Professional Hydrochlorothiazide Plendil (Felodipine Sr) Atenolol Zocor (Simvastatin) Insulin C Route Therapeutic 3.0 DAILY Dyspnoea Pulmonary Oedema Date:03/27/98ISR Number: 3062164-4Report Type:Direct Age:31 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG QID PT Overdose C C C C Company Report # Report Source Product Role Lithium PS Manufacturer Route ORAL Initial or Prolonged ORAL Risperidone Vitamin B Complex Cap Date:03/31/98ISR Number: 3062158-9Report Type:Direct Age: Gender: I/FU:I Outcome Dose PT C Company Report # Report Source Product Role Lithium PS Manufacturer Route Manufacturer Route Duration Diabetes Insipidus Date:03/31/98ISR Number: 3063232-3Report Type:Direct Age:74 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 27 C 10:48 AM Company Report # PT Report Source Product Role Difficulty In Walking Disorientation Posture Abnormal Health Professional Lithium PS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/98ISR Number: 3071856-2Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose PT Company Report # Report Source Product Role Clozapine PS Lithun Carbonate SS Manufacturer Route Duration Ileus Paralytic ORAL 700 MG / DAY PO BID 300MG TID Date:04/02/98ISR Number: 3071716-7Report Type:Direct Age:46 YR Gender:Male I/FU:I Outcome Dose PT Company Report # Report Source Product Role Lithium Carbonate PS Manufacturer Route Manufacturer Route Duration Dysarthria 300 MG III Movement Disorder QAM II QPM Sedation Tremor Date:04/03/98ISR Number: 3061334-9Report Type:Expedited (15-DaCompany Report #9806748 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Serotonin Syndrome Health Lithane PS Professional Trilafon Klonopin Trazodone Nardil C C C C ORAL Date:04/06/98ISR Number: 3063010-5Report Type:Expedited (15-DaCompany Report #9905149 Age:36 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Death 500.00 MG PO Hospitalization QD Initial or Prolonged 800 MG PO Agitation Foreign Blood Thyroid Stimulating Health Hormone Increased Professional Bundle Branch Block Electrocardiogram Normal Excitability Date:04/06/98ISR Number: 3152715-3Report Type:Periodic Age:35 YR Gender:Male I/FU:I Outcome Dose Other 10.00 MG Depakene PS Lithium Carbonate SS Diazepam Clonazepam C C Abbott ORAL ORAL Company Report #9725041 PT Report Source Product Role Manufacturer Route Drug Toxicity Health Zyrtec PS ORAL Hyperhidrosis Professional Lithium SS ORAL Erythromycin Ointment Restoril Akineton Haldol Deconoate Elavil Anaprox Ds Beconase C C C C C C C Duration TOTAL: DAILY: Nervousness ORAL Tremor ORAL 22-Aug-2005 Page: 28 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/98ISR Number: 3063332-8Report Type:Expedited (15-DaCompany Report #8-98086-028A Age:25 YR Gender:Female I/FU:I Outcome Dose Duration Other 250 MD DAILY PT Report Source Product Role Manufacturer Route Electroencephalogram Foreign Stangyl PS ORAL Abnormal Health Grand Mal Convulsion Professional Diazepam SS ORAL Lithium Carbonate SS Olanzapine SS ORAL 40 MG DAILY UNTIL 1/16 THEN 5 MG DAILY 1000 MG DAILY 20 MG DAILY THEN 30 MG DAILY SINCE 2/4 Date:04/07/98ISR Number: 3153599-XReport Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose ORAL Company Report #1997005654-1 PT Report Source Product Role Manufacturer Route Alopecia Consumer Eskalith PS Smithkline Beecham ORAL Risperidone Premarin Provera Multiple Vitamins C C C C Duration 24 MON Date:04/07/98ISR Number: 3153600-3Report Type:Periodic Age: Gender: I/FU:I Company Report #1997007414-1 Outcome Dose PT Report Source Product Role Manufacturer Route Drug Level Below Health Eskalith PS Smithkline Beecham ORAL Therapeutic Professional Duration 450 MILLIGRAMS 2.0 DAILY ORAL Date:04/07/98ISR Number: 3153601-5Report Type:Periodic Age:58 YR Gender:Male I/FU:I Outcome Dose Company Report #1997007473-1 PT Report Source Product Role Manufacturer Route Diabetes Insipidus Health Eskalith PS Smithkline Beecham ORAL Diarrhoea Professional Duration 450 MILLIGRAMS 2.0 DAILY ORAL Date:04/07/98ISR Number: 3153602-7Report Type:Periodic Age:53 YR Gender:Female I/FU:I Outcome Dose Company Report #1997013298-1 PT Report Source Product Role Manufacturer Route Dizziness Consumer Eskalith PS Smithkline Beecham ORAL Paxil SS ORAL Paxil SS ORAL Duration 450 Malaise MILLIGRAMS Pain In Extremity 1.0 DAILY ORAL 10 MILLIGRAMS 1.0 DAILY ORAL 5 MILLIGRAMS 1.0 DAILY ORAL 22-Aug-2005 Page: 29 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/98ISR Number: 3153603-9Report Type:Periodic Age:31 YR Gender:Female I/FU:I Outcome Dose Company Report #1997018471-1 PT Report Source Product Role Manufacturer Route Flushing Health Eskalith PS Smithkline Beecham ORAL Duration 450 Professional MILLIGRAMS 3.0 DAILY ORAL Date:04/07/98ISR Number: 3153604-0Report Type:Periodic Age:14 YR Gender:Female I/FU:I Outcome Dose Company Report #1997027460-1 PT Report Source Product Role Manufacturer Route Diarrhoea Health Eskalith PS Smithkline Beecham ORAL Hypomania Professional Eskalith SS Smithkline Beecham ORAL Duration 2.0 DAILY ORAL Nausea 300 MILIGRAMS 2.0 DAILY ORAL Date:04/07/98ISR Number: 3153605-2Report Type:Periodic Age:57 YR Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Manufacturer Route Dyspnoea Consumer Eskalith PS Smithkline Beecham ORAL Duration 900 Movement Disorder MILLIGRAMS Muscle Twitching 1.0 DAILY Tremor ORAL Company Report #1998003859-1 Zoloft Date:04/07/98ISR Number: 3153606-4Report Type:Periodic Age:40 YR Gender:Female I/FU:F Outcome Dose C Company Report #1997000161-1 PT Report Source Product Role Manufacturer Route Diabetes Insipidus Health Eskalith PS Smithkline Beecham ORAL Polyuria Professional Depakote Tenex Klonopin Claritin Theophylline C C C C C Duration 450 MILLIGRAMS 2.0 DAILY ORAL Date:04/07/98ISR Number: 3153608-8Report Type:Periodic Age:53 YR Gender:Male I/FU:I Outcome Dose Company Report #1997009176-1 PT Report Source Product Role Manufacturer Route Drug Interaction Health Eskalith PS Smithkline Beecham ORAL Duration 300 Professional MILLIGRAMS 2.0 DAILY ORAL 22-Aug-2005 Page: 30 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/98ISR Number: 3153610-6Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Company Report #1997009446-1 PT Report Source Product Role Manufacturer Route Alopecia Consumer Eskalith PS Smithkline Beecham ORAL Effexor Xanax Depakote C C C Duration 450 Tremor MILLIGRAMS 1.0 DAILY ORAL Date:04/07/98ISR Number: 3153612-XReport Type:Periodic Age:23 YR Gender:Female I/FU:I Outcome Dose Company Report #1998000691-1 PT Report Source Product Role Manufacturer Route Menstruation Irregular Consumer Eskalith PS Smithkline Beecham ORAL Wellbutrin C Duration 450 MILLIGRAMS 2.0 DAILY ORAL Date:04/07/98ISR Number: 3153614-3Report Type:Periodic Age:55 YR Gender:Female I/FU:I Outcome Dose Company Report #1997002927-1 PT Report Source Product Role Manufacturer Route Polyuria Health Eskalith PS Smithkline Beecham ORAL Urinary Incontinence Professional Duration 300 MILLIGRAMS 2.0 DAILY ORAL 3 YR Date:04/07/98ISR Number: 3153615-5Report Type:Periodic Age:68 YR Gender:Female I/FU:I Outcome Dose Company Report #1997003303-1 PT Report Source Product Role Skin Odour Abnormal Consumer Eskalith PS Zantac Naprosyn C C Manufacturer Route Duration ORAL 2.0 DAILY ORAL Date:04/07/98ISR Number: 3153616-7Report Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose Company Report #1997003658-1 PT Report Source Product Role Manufacturer Route Constipation Consumer Eskalith PS Smithkline Beecham ORAL Dermatitis Diarrhoea Fatigue Health Professional Prozac C Duration ORAL Date:04/07/98ISR Number: 3153617-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #1997005636-1 PT Report Source Product Role Manufacturer Route Hypercalcaemia Health Eskalith PS Smithkline Beecham ORAL Hyperparathyroidism Professional Duration ORAL 22-Aug-2005 Page: 31 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/98ISR Number: 3153618-0Report Type:Periodic Age:41 YR Gender:Male I/FU:I Outcome Dose Company Report #1997006020-1 PT Report Source Product Role Manufacturer Route Drug Toxicity Consumer Eskalith PS Smithkline Beecham ORAL Depakote Lamotrigine Risperidal Synthroid C C C C Duration ORAL Migraine Date:04/07/98ISR Number: 3153619-2Report Type:Periodic Age:54 YR Gender:Female I/FU:I Outcome Dose Company Report #1997010924-1 PT Report Source Product Role Manufacturer Route Blood Calcium Increased Health Eskalith PS Smithkline Beecham ORAL Blood Parathyroid Hormone Professional Premarin Moban Ambien Prozac C C C C Duration 450 MILLIGRAMS Increased 2.0 DAILY Gastrointestinal Disorder ORAL Nausea Date:04/07/98ISR Number: 3153620-9Report Type:Periodic Age:30 YR Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Manufacturer Route Muscle Spasms Consumer Eskalith PS Smithkline Beecham ORAL Duration 300 Muscle Twitching MILLIGRAMS 3.0 DAILY ORAL/300 Company Report #1997011697-1 MILLIGRAM 2.0 Dilantin Phenobarbital Tegretol Date:04/07/98ISR Number: 3153621-0Report Type:Periodic Age: Gender: I/FU:I Outcome Dose C C C Company Report #1997011729-1 PT Report Source Product Role Hyperthyroidism Consumer Lithium PS Xanax C Manufacturer Route Duration ORAL 600 Health MILLIGRAMS Professional 2.0 DAILY ORAL Date:04/07/98ISR Number: 3153622-2Report Type:Periodic Age: Gender: I/FU:I Outcome Dose 22-Aug-2005 Page: 32 Company Report #1997011782-1 PT Report Source Product Role Hyperkeratosis Health Professional Lithium PS Duration 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/98ISR Number: 3153843-9Report Type:Periodic Age: Gender: I/FU:I Outcome Dose PT Report Source Product Role Manufacturer Renal Failure Acute Health Professional Eskalith PS Smithkline Beecham Company Report #1997015517-1 PT Report Source Product Role Manufacturer Leukocytosis Consumer Eskalith PS Smithkline Beecham Route Duration Date:04/07/98ISR Number: 3153848-8Report Type:Periodic Age:45 YR Gender:Male I/FU:I Outcome Dose Route Duration Date:04/07/98ISR Number: 3153846-4Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #1997014796-1 Company Report #1997015975-1 PT Report Source Product Role Manufacturer Route Acne Consumer Eskalith PS Smithkline Beecham ORAL Depakote (Divalproex Sodium) C Route Duration 300 Back Disorder MILLIGRAMS Capillary Disorder 4.0 DAILY Muscle Disorder 300MG 2 DAILY Skin Disorder Date:04/07/98ISR Number: 3153850-6Report Type:Periodic Age:80 YR Gender:Male I/FU:I Outcome Dose PT Report Source Product Role Manufacturer Bleeding Time Shortened Consumer Eskalith PS Smithkline Beecham Duration 450 Drug Effect Decreased MILLIGRAMS Company Report #1997017864-1 2.0 DAILY Coumadin Lasix Date:04/07/98ISR Number: 3153852-XReport Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 3.0 DAILY Initial or Prolonged 2.0 DAILY C C Company Report #1997017935-1 PT Report Source Product Role Manufacturer Route Loss Of Consciousness Health Eskalith PS Smithkline Beecham ORAL Synthroid C Route Professional PO Date:04/07/98ISR Number: 3153854-3Report Type:Periodic Age: Gender: I/FU:I Outcome Dose PT Report Source Product Role Manufacturer Psoriasis Health Professional Eskalith Depakote PS C Smithkline Beecham Duration Date:04/07/98ISR Number: 3153857-9Report Type:Periodic Age:30 YR Gender:Female I/FU:I Outcome Dose Company Report #1997018032-1 Company Report #1997019331-1 PT Report Source Product Role Manufacturer Route Raynaud'S Phenomenon Health Eskalith PS Smithkline Beecham ORAL Duration 750 Professional MILLIGRAMS 22-Aug-2005 Page: 33 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 2.0 DAILY Risperdal Date:04/07/98ISR Number: 3153858-0Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose 4 C Company Report #1997019784-1 PT Report Source Product Role Manufacturer Route Weight Increased Consumer Eskalith PS Smithkline Beecham ORAL Zestril Enduron Potassium C C C Duration YR Date:04/07/98ISR Number: 3153860-9Report Type:Periodic Age:4 YR Gender:Female I/FU:I Outcome Dose Company Report #1997019914-1 PT Report Source Product Role Manufacturer Route Asthma Health Lithium PS Roxan Laboratories ORAL Duration 150 Professional MILLIGRAMS 3.0 DAILY Date:04/07/98ISR Number: 3153862-2Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose 300 MILLIGRAMS 1.0 DAILY Company Report #1997021397-1 PT Report Source Product Role Manufacturer Route Alopecia Consumer Eskalith PS Smithkline Beecham ORAL Duration Date:04/07/98ISR Number: 3153865-8Report Type:Periodic Age: Gender: I/FU:I Outcome Dose PT Report Source Product Role Manufacturer Route Blood Alkaline Phosphatase Increased Blood Creatinine Increased Blood Urea Increased Diabetes Insipidus Hyponatraemia Health Professional Eskalith PS Smithkline Beecham ORAL Duration Date:04/07/98ISR Number: 3153866-XReport Type:Periodic Age:37 YR Gender:Male I/FU:I Outcome Dose Company Report #1997021987-1 Company Report #1997022826-1 PT Report Source Product Role Manufacturer Route Fat Tissue Increased Consumer Eskalith PS Smithkline Beecham ORAL Hair Disorder Health Crixivan 3tc Zovirax Diflucan Oxandrin Zerit D4t Pentamidine Ethambutol Biaxin C C C C C C C C C C Duration 450 MILLIGRAMS Professional 3.0 DAILY 22-Aug-2005 Page: 34 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/98ISR Number: 3153869-5Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Manufacturer Route Hypercalcaemia Hyperparathyroidism Consumer Eskalith PS Smithkline Beecham ORAL Duration Date:04/07/98ISR Number: 3153871-3Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Company Report #197022844-1 PT Report Source Product Role Manufacturer Route Diarrhoea Health Professional Eskalith PS Smithkline Beecham ORAL Duration Date:04/07/98ISR Number: 3153872-5Report Type:Periodic Age:45 YR Gender:Male I/FU:I Outcome Dose Company Report #1997022839-1 Company Report #1997023225-1 PT Report Source Product Role Manufacturer Route Cold Sweat Consumer Eskalith PS Smithkline Beecham ORAL Prolixin Risperdal C C Manufacturer Route Duration 1.0 DAILY Decreased Appetite Hyperhidrosis Nausea Date:04/09/98ISR Number: 3062812-9Report Type:Expedited (15-DaCompany Report #9803770 Age:51 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 5.00 MG Initial or Prolonged TOTAL:DAILY:O PT Report Source Product Role Confusional State Foreign Minipress PS Dysarthria Health Hypothyroidism Professional Lithium Carbonate Haloperidol Clobazam SS C C RAL Sinus Bradycardia Therapeutic Agent Toxicity ORAL Tremor Citalopram Carbamazepine Disulfirame C C C Date:04/09/98ISR Number: 3062813-0Report Type:Expedited (15-DaCompany Report #9803770 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged ORAL PT Product Role Confusional State Minipress PS ORAL Dysarthria Lithium Carbonate SS ORAL Sinus Bradycardia Therapeutic Agent Toxicity Tremor Haloperidol Clobazam Citalopram Carbamazepine Disulfirame C C C C C Date:04/13/98ISR Number: 3073098-3Report Type:Direct Age:37 YR Gender:Male I/FU:I Outcome PT Dose Duration Required Polyuria 1T QD & 2HS Intervention to Tremor 2QD 6 DAY Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 35 10:48 AM Report Source Manufacturer Route Company Report # Report Source Product Role Eskalith Cr PS Relafen SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/98ISR Number: 3064399-3Report Type:Expedited (15-DaCompany Report #1998008534-1 Age:45 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Dehydration Diabetic Hyperosmolar Coma Nephrogenic Diabetes Insipidus Pancreatitis Polyuria Literature Lithium PS Date:04/22/98ISR Number: 3071981-6Report Type:Direct Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 2G, 600MG BI, Initial or Prolonged ORAL; PT Manufacturer Route Manufacturer Route Company Report # Report Source Hyperglycaemia Product Role Lithium Carbonate PS ORAL THERAPY: CHRONIC Date:04/23/98ISR Number: 3073076-4Report Type:Direct Age:21 YR Gender:Female I/FU:I Outcome Dose Other 300MG AD PO PT Company Report # Report Source Product Role Lithonate PS Manufacturer Route Duration Headache ORAL Date:04/24/98ISR Number: 3068508-1Report Type:Expedited (15-DaCompany Report #US_ 980401526 Age:51 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization 900 MG/DAY Initial or Prolonged Condition Aggravated Study Lithium PS Delusional Disorder, Persecutory Type Insomnia Health Professional Ativan C Date:04/24/98ISR Number: 3072192-0Report Type:Direct Age:21 YR Gender:Female I/FU:I Outcome Dose Duration Other 300MG A D PO PT Headache Company Report # Report Source Product Role Lithonate PS Date:04/28/98ISR Number: 3071672-1Report Type:Expedited (15-DaCompany Report #B038068 Age:59 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 36 10:48 AM PT Anxiety Blood Creatine Phosphokinase Increased Blood Pressure Fluctuation Clonic Convulsion Coma Coordination Abnormal Delirium Depression Drug Interaction Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Dysarthria Hyperhidrosis Hyperreflexia Report Source Product Role Insomnia Foreign Trazodone PS ORAL Irritability Literature Medication Error Health Amitriptyline SS ORAL Muscle Rigidity Professional Lithium Carbonate SS Leveomepromazine Nitrazepam C C Manufacturer Route Duration 25-250 MG QD ORAL 75 MG QD ORAL 400-800MG 13 DAY QD Pyrexia ORAL Restlessness Serotonin Syndrome Tremor White Blood Cell Count Increased Date:04/30/98ISR Number: 3070686-5Report Type:Expedited (15-DaCompany Report #9800488 Age:19 YR Gender:Male I/FU:F Outcome Dose Duration Death 50.00 MG Hospitalization TOTAL:DAILY:O Initial or Prolonged RAL PT Report Source Product Role Manufacturer Route Abdominal Pain Health Zoloft PS ORAL Bipolar Disorder Professional Xanax Lithium SS SS ORAL Risperidone SS ORAL Cogentin C Blood Lactate Dehydrogenase Decreased Blood Sodium Decreased 900.00 MG Eye Movement Disorder TOTAL:TID:ORA Haematuria L Ketonuria 9.00 MG Movement Disorder TOTAL:TID:ORA Nervous System Disorder L Urinary Tract Infection Ativan Restoril Haldol Decanoate Haldol C C C C Date:04/30/98ISR Number: 3070689-0Report Type:Expedited (15-DaCompany Report #9800488 Age:19 YR Gender:Male I/FU:I Outcome Dose Duration Death 50.00 MG Hospitalization TOTAL:DAILY:O Initial or Prolonged RAL PT Report Source Product Role Manufacturer Route Abdominal Pain Health Zoloft PS ORAL Blood Lactate Professional Xanax Lithium SS SS ORAL Risperidone SS ORAL Cogentin Ativan Restoril Haldol Decanoate Haldol C C C C C Dehydrogenase Decreased Blood Sodium Decreased Eye Movement Disorder 900.00 MG Haematuria TOTAL:TID:ORA Ketonuria L Movement Disorder 9.00 MG Nervous System Disorder TOTAL:TID:ORA Overdose L Urinary Tract Infection 22-Aug-2005 Page: 37 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/98ISR Number: 3070860-8Report Type:Expedited (15-DaCompany Report #9905149 Age:36 YR Gender:Female I/FU:F Outcome Dose Duration Death 500.00MG/PO/Q Hospitalization D Initial or Prolonged PO PT Report Source Product Role Manufacturer Route Agitation Foreign Depakene PS Abbott ORAL Blood Thyroid Stimulating Health Hormone Increased Professional Lithium Carbonate SS Diazepam Clonazepam C C Bundle Branch Block Electrocardiogram Normal Excitability ORAL Date:05/04/98ISR Number: 3074202-3Report Type:Expedited (15-DaCompany Report #WAES 98036106 Age:77 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening 5 MG PO 15 DAY Hospitalization 750 MG ORAL Initial or Prolonged PT Report Source Product Role Manufacturer Route Drug Interaction Foreign Vasotec PS ORAL Electrocardiogram Other Lithium SS ORAL Abnormal Ventricular Arrhythmia Date:05/06/98ISR Number: 3074082-6Report Type:Expedited (15-DaCompany Report #9810664 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization TAB PO Initial or Prolonged PT Report Source Product Role Unevaluable Event Consumer Zoloft PS Lithium SS Date:05/08/98ISR Number: 3074557-XReport Type:Direct Age:69 YR Gender:Male I/FU:I Outcome Dose PT Duration Manufacturer Route ORAL Company Report # Report Source Product Role Manufacturer Route Hospitalization PO - DOSE Initial or Prolonged UNKNOWN Required Intervention to Prevent Permanent Impairment/Damage Bradycardia 10:48 AM ORAL Heart Rate Decreased Hypotension Hypothermia Hypothyroidism Nephrogenic Diabetes Insipidus PT Bradycardia Company Report # Report Source Product Role Lithium PS Tegretol Risperdal Thorazine Multivitamin Klonopin C C C C C Depressed Level Of Consciousness Hypotension Hypothermia Lethargy 22-Aug-2005 Page: 38 PS Coma Date:05/08/98ISR Number: 3086666-XReport Type:Direct Age:34 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization PO;THERAPY: Initial or Prolonged FOR SOME TIME Lithium Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/98ISR Number: 3163032-XReport Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other ORAL Company Report #9803056 PT Report Source Product Role Intentional Misuse Consumer Lithane Tablets PS Manufacturer Route Duration ORAL Medication Error Tremor Date:05/12/98ISR Number: 3163033-1Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other 1200.00 MG Company Report #9807323 PT Report Source Product Role Constipation Consumer Lithane Tablets PS ORAL Atarax SS ORAL Mellaril SS ORAL Seroquel Xanax Klonopin Neurontin C C C C Manufacturer Route Duration Depression TOTAL;BID;ORA Dermatitis L Pruritus 100.00 MG Sedation TOTAL;BID;ORA L ORAL Date:05/12/98ISR Number: 3163034-3Report Type:Periodic Age:64 YR Gender:Female I/FU:I Outcome Dose Other ORAL Company Report #9808181 PT Report Source Product Role Thyroid Disorder Consumer Lithane Tablets PS Glucotrol Xl Norvasc C C Manufacturer Route Duration ORAL Date:05/12/98ISR Number: 3163035-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other ORAL PT Report Source Product Role Drug Ineffective Health Lithane Tablets PS Professional Iron C Manufacturer Route Duration Date:05/12/98ISR Number: 3163037-9Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other 1800.00 MG Company Report #9808189 ORAL Company Report #9809139 PT Report Source Product Role Manufacturer Erectile Dysfunction Consumer Lithane Tablets PS ORAL Zoloft SS ORAL Route Duration TOTAL;TID;ORA L 50.00 MG TOTAL;DAILY;O RAL Date:05/13/98ISR Number: 3077134-XReport Type:Expedited (15-DaCompany Report #1998011902-1 Age:72 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 39 10:48 AM PT Blepharospasm Chorea Coordination Abnormal FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dehydration Depressed Level Of Consciousness Dose Report Source Product Role Literature Lithium PS Manufacturer Route Route Duration Disorientation Drug Level Above Therapeutic Dysarthria Dyskinesia Reflexes Abnormal Tardive Dyskinesia Tremor Date:05/13/98ISR Number: 3078225-XReport Type:Expedited (15-DaCompany Report #1998011607-1 Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 10 YR Initial or Prolonged Other PT Report Source Product Role Manufacturer Blood Sodium Increased Literature Lithium PS Smithkline Beecham Manufacturer Diabetic Hyperosmolar Coma Nephrogenic Diabetes Insipidus Nocturia Pancreatitis Acute Polyuria Date:05/18/98ISR Number: 3080058-5Report Type:Expedited (15-DaCompany Report #LITH002980010 Age:50 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Clonic Convulsion VARIED, PER Initial or Prolonged Gait Disturbance ORAL 45 DAY Hyperreflexia 37.5-225 MG, Muscle Rigidity 262.5MG,187.5 Restlessness MG,PER ORAL 45 DAY Report Source Product Role Route Foreign Lithium PS ORAL Venlafaxine SS ORAL Literature Serotonin Syndrome Tachycardia Date:05/18/98ISR Number: 3080652-1Report Type:Expedited (15-DaCompany Report #1998012322-1 Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Cardiomegaly Pericardial Effusion Respiratory Failure Respiratory Gas Exchange Disorder Health Professional Quilonorm PS Smithkline Beecham Route Date:05/18/98ISR Number: 3081718-2Report Type:Expedited (15-DaCompany Report #1998001632-1 Age:59 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 675 Initial or Prolonged MILLIGRAMS PT Report Source Product Role Manufacturer Route Asthenia Health Quilonum PS Smithkline Beecham ORAL Hypergammaglobulinaemia Professional Allopurinol C Benign Monoclonal Paraesthesia Plasmacytoma Polyneuropathy 22-Aug-2005 Page: 40 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/98ISR Number: 3080074-3Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 900 MG PO QHS Initial or Prolonged PT Company Report # Report Source Confusional State Product Role Lithium Carbonate PS Manufacturer Route ORAL Nausea Tongue Oedema Vomiting Date:05/19/98ISR Number: 3081148-3Report Type:Expedited (15-DaCompany Report #1998012336-1 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Nephropathy Toxic Health Professional Lithium PS Manufacturer Route Manufacturer Route Duration Date:05/22/98ISR Number: 3081006-4Report Type:Direct Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 1800 MG, 3T Hospitalization BID, ORAL Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Dysphagia Product Role Lithium PS Carbamazepine Haloperidol Trihexyphenidyl C C C ORAL Hallucination Nausea Vomiting Weight Decreased Date:05/22/98ISR Number: 3081024-6Report Type:Direct Age:48 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG QID Company Report # PT Dysarthria Company Report # Report Source Product Role Lithium PS Manufacturer Route Initial or Prolonged Renal Failure Acute Therapeutic Agent Toxicity Tremor Date:05/26/98ISR Number: 3082977-2Report Type:Expedited (15-DaCompany Report #LBID002980014 Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600 MG, PER Initial or Prolonged DAY, PER ORAL PT Report Source Product Role Diarrhoea Consumer Lithobid PS Prozac Xanax C C Drug Level Above Therapeutic Hyperhidrosis Hypertension Restlessness Vomiting Date:05/26/98ISR Number: 3084410-3Report Type:Direct Age:22 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Required 22-Aug-2005 Page: 41 10:48 AM Company Report # Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Dose Report Source Product Role Dyspnoea Lithium PS Insomnia Malaise Nausea Respiratory Rate Increased Restlessness Vomiting Haloperidol SS Manufacturer Route Manufacturer Route Manufacturer Route Duration 300 MG TID Date:05/27/98ISR Number: 3083411-9Report Type:Direct Age:74 YR Gender:Male I/FU:I Outcome Dose PT Company Report # Report Source Product Role Amnesia Lithium PS Asthenia Humulin N SS Confusional State Drug Toxicity Insomnia Tremor Hismopril Asa Temazonym Thyrotime Ntg B1 C C C C C C Duration 300MG BID 30U BID Date:05/27/98ISR Number: 3083438-7Report Type:Direct Age:40 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization PO 900MG BID Initial or Prolonged X YEARS YR PT Diabetes Insipidus Drug Toxicity Mental Impairment Sedation Company Report # Report Source Product Role Lithium PS ORAL Date:05/28/98ISR Number: 3084591-1Report Type:Expedited (15-DaCompany Report #1998013117-1 Age: Gender:Not SpecifiI/FU:I Outcome Dose Other UNKNOWN PT Report Source Product Role Health Lithium PS Manufacturer Route Route Duration Condition Aggravated UNKNOWN Convulsion Professional Date:05/28/98ISR Number: 3084856-3Report Type:Expedited (15-DaCompany Report #1998012855-1 Age:50 YR Gender:Female I/FU:I Outcome Dose Other 22-Aug-2005 Page: 42 PT Report Source Product Role Manufacturer Chills Clonic Convulsion Gait Disturbance Hyperreflexia Restlessness Serotonin Syndrome Tachycardia Literature Lithium Venlafaxine PS C Smithkline Beecham Duration 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/98ISR Number: 3085347-6Report Type:Expedited (15-DaCompany Report #9813588 Age:75 YR Gender:Female I/FU:I Outcome Dose Duration Required 250 MG Intervention to TOTAL:DAILY:O Prevent Permanent RAL Impairment/Damage ORAL PT Report Source Product Role Manufacturer Route Confusional State Consumer Zoloft PS ORAL Infarction Lithium SS ORAL Insomnia Aricept SS ORAL Depression Fall 5 MG Mood Altered TOTAL:DAILY:O Overdose RAL Date:05/29/98ISR Number: 3085632-8Report Type:Expedited (15-DaCompany Report #9813535 Age: Gender:Unknown I/FU:I Outcome Dose Duration Life-Threatening ORAL Hospitalization ORAL Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Convulsion Foreign Lithane PS ORAL Coordination Abnormal Health Thiothixene SS ORAL Drug Interaction Professional Date:06/01/98ISR Number: 3086984-5Report Type:Direct Age:86 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG PO BID Initial or Prolonged PT Manufacturer Route Company Report # Report Source Product Role Renal Failure Acute Lithium PS Therapeutic Agent Lasix C Manufacturer Route ORAL Toxicity Digoxin Zestoril Zyprexa K-Dur Depakane Verapamil Metamicil Amantadine C C C C C C C C Date:06/01/98ISR Number: 3087479-5Report Type:Expedited (15-DaCompany Report #B0056236 Age:60 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization INHALED Initial or Prolonged PT Report Source Product Role Cardiac Failure Foreign Ventolin PS Lower Respiratory Tract Infection Health Professional Chlorpromazine Lithium Frusemide SS SS SS Manufacturer Route ORAL 40 MG /ORAL Date:06/02/98ISR Number: 3088393-1Report Type:Expedited (15-DaCompany Report #LBIDOO2980015 Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG PT Report Source Product Role Bladder Pain Blood Creatine Increased Hepatotoxicity Health Professional Lithobid Tablats 300 Mg (Lithium Carbonate) PS PER Jaundice ORAL Mania Nephropathy Toxic 22-Aug-2005 Page: 43 10:48 AM Pyridium (Phenazopyridine Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS ORAL ORAL Date:06/02/98ISR Number: 3161082-0Report Type:Periodic Age:6 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report #LITH002970016 PT Report Source Product Role Abdominal Distension Accidental Overdose Hallucination Health Professional Lithium Carbonate Capsules (Lithium Carbonate) PS Manufacturer Route ORAL UNK, PER ORAL Date:06/02/98ISR Number: 3161086-8Report Type:Periodic Age:51 YR Gender:Male I/FU:I Outcome Dose Disability Company Report #LITH002970028 PT Report Source Product Role Diabetes Insipidus Pollakiuria Thirst Other Lithium Carbonate Capsules 300 Mg (Lithium Carbonate) PS Thorazine (Chlorpromazine Hydrochloride) C Manufacturer Route Duration ORAL 600-900 MG/DAY, PER ORAL Date:06/02/98ISR Number: 3161090-XReport Type:Periodic Age:60 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LITH002970008 PT Report Source Product Role Skin Nodule Health Professional Lithium Capsules 300 Mg (Lithium Carbonate) PS Manufacturer Route Duration 900 MG, PER DAY, PER ORAL Benadryl ORAL (Diphenhydramine Hydrochloride) Date:06/02/98ISR Number: 3161094-7Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other C Company Report #LITH002970009 PT Report Source Product Role Back Pain Hypertonia Insomnia Consumer Lithium Carbonate Capsules 300 Mg (Lithium Carbonate) PS Manufacturer Route Duration ORAL PER ORAL Date:06/02/98ISR Number: 3161096-0Report Type:Periodic Age:53 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LITH002970019 PT Report Source Product Role Hypothyroidism Pollakiuria Sedation Health Professional Lithium Capsules 300 Mg (Lithium Carbonate) PS Acetic Acid Ear Drops Albuterol Sulfate Betopic Eye Drops Klonopin Navane C C C C C 900 MG, PER Thirst ORAL Thyroid Disorder Urinary Tract Infection Weight Increased 22-Aug-2005 Page: 44 Manufacturer Route Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/98ISR Number: 3161099-6Report Type:Periodic Age:37 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LITH002970022 PT Report Source Product Role Drug Withdrawal Syndrome Migraine Consumer Lithium Carbonate Capsules 300 Mg (Lithium Carbonate) PS Copaxone Diazepam Tegretol C C C Manufacturer Route Duration ORAL 1200 MG, PER ORAL Date:06/02/98ISR Number: 3161105-9Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #LITH002970025 PT Report Source Product Role Salivary Hypersecretion Consumer Lithonate Capsules 300 Mg ( Lithium Carbonate) PS Manufacturer Route Duration ORAL UNKNOWN, PER ORAL Date:06/02/98ISR Number: 3161108-4Report Type:Periodic Age:45 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LITH002970026 PT Report Source Product Role Drug Ineffective Emotional Disorder Tremor Consumer Lithonate Capsules 300 Mg ( Lithium Carbonate) PS Paxil Synthroid C C Manufacturer Route Duration 1200 MG; PER ORAL ORAL Date:06/02/98ISR Number: 3161112-6Report Type:Periodic Age:15 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LITH002970027 PT Report Source Product Role Manufacturer Route Galactorrhoea Health Professional Lithium Carbonate Capsules 300 Mg (Lithium Carbonate) PS ORAL Paroxetine (Paroxetine) SS ORAL Duration 1500 MG, PER DAY, PER ORAL UNKNOWN, PER ORAL Date:06/02/98ISR Number: 3161115-1Report Type:Periodic Age:42 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Diarrhoea Tremor Visual Disturbance Consumer Lithium Capsules 300 Mg (Lithium Carbonate) PS Manufacturer Route Duration 1200 MG PER ORAL 22-Aug-2005 Page: 45 Company Report #LITH002970033 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/98ISR Number: 3161117-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LITH002970036 PT Report Source Product Role Face Oedema Hypersensitivity Pruritus Health Professional Lithonate Capsules 300 Mg (Lithium Carbonate) PS Manufacturer Route Duration ORAL 600 MG BID, Urticaria PER ORAL Date:06/04/98ISR Number: 3090415-9Report Type:Expedited (15-DaCompany Report #1998013455-1 Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Blood Creatinine Increased Blood Urea Increased Hyperkalaemia Metabolic Acidosis Nephropathy Renal Failure Acute Scan Abdomen Abnormal Therapeutic Agent Toxicity Literature Lithium PS Smithkline Beecham ORAL Route Date:06/04/98ISR Number: 3091134-5Report Type:Expedited (15-DaCompany Report #1998013456-1 Age:54 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Blood Creatinine Increased Blood Urea Increased Colon Cancer Stage Iv Renal Failure Literature Lithium PS Smithkline Beecham Duration Date:06/04/98ISR Number: 3091139-4Report Type:Expedited (15-DaCompany Report #1998013457-1 Age:44 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Blood Creatinine Increased Blood Urea Increased Nephropathy Renal Atrophy Renal Impairment Literature Lithium PS Smithkline Beecham Manufacturer Date:06/04/98ISR Number: 3175328-6Report Type:Periodic Age:54 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LITT002970001 PT Report Source Product Role Osteoporosis Consumer Lithotabs Tablets 300 Mg (Lithium Carbonate) PS Route Duration 300 MG, PER ORAL Anafranil (Clomipramine Hydrochloride) Cardura (Doxazosin Mesilate) 22-Aug-2005 Page: 46 Route Duration 10:48 AM C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Darvocet-N-100 (Paracetamol, Dextropropoxyphene) Luvox Tablets 100 Mg (Fluvoxamine Maleate) Mysoline (Primidone) Oxybutynin Primex (Bumetanide) Sinemet (Levodopa, Carbidopa) Zoloft (Sertraline Hydrochloride) Date:06/04/98ISR Number: 3175330-4Report Type:Periodic Age:41 YR Gender:Male I/FU:I Outcome Dose Other C C C C C C C Company Report #LITT002980001 PT Report Source Product Role Alanine Aminotransferase Increased Gamma-Glutamyltransferase Consumer Lithotabs Tablets 300 Mg (Lithium Carbonate) PS Manufacturer Route Duration ORAL 1500 MG, PER Increased ORAL Date:06/08/98ISR Number: 3090075-7Report Type:Direct Age:57 YR Gender:Male I/FU:I Outcome Dose Duration Required 900 MG PO. QD 2 YR Intervention to Prevent Permanent Impairment/Damage PT Confusional State Company Report # Report Source Product Role Lithium PS Drug Level Above Therapeutic Drug Toxicity Gait Disturbance Date:06/08/98ISR Number: 3091448-9Report Type:Direct Age:41 YR Gender:Male I/FU:I Company Report # Manufacturer Route ORAL Outcome Dose Duration Hospitalization 900 MG PO BID Initial or Prolonged PT Report Source Mental Disorder Product Role Lithium PS Manufacturer Route ORAL Therapeutic Agent Toxicity Date:06/08/98ISR Number: 3092027-XReport Type:Expedited (15-DaCompany Report #1998014020-1 Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 Initial or Prolonged MILLIGRAMS PT Report Source Product Role Coma Health Lithium PS Depressed Level Of Professional Hydrochlorothiazide Risperdal C C Consciousness 3.0 DAILY 10 DAY Drug Level Above Therapeutic Pneumonia Subdural Haematoma 22-Aug-2005 Page: 47 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3092033-5Report Type:Expedited (15-DaCompany Report #1998012769-1 Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Manufacturer Route Confusional State Health Eskalith PS Smithkline Beecham ORAL Dehydration Diabetes Mellitus Hyperglycaemia Hyperosmolar State Hypotension Loss Of Consciousness Professional Product Role Manufacturer Route Lithium PS Manufacturer Route Date:06/09/98ISR Number: 3091805-0Report Type:Direct Age:43 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 300MG TID Company Report # PT Report Source Asthenia Blood Creatine PRIOR TO Phosphokinase Increased ADMISSION Cardiac Murmur Functional Difficulty In Walking Dizziness Drug Toxicity Hypertension Nephrogenic Diabetes Insipidus Neuroleptic Malignant Syndrome Tremor Date:06/10/98ISR Number: 3179918-6Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #LITH002970038 PT Report Source Product Laboratory Test Abnormal Health Lithium Carbonate Duration Role Professional (Lithium Carbonate) PS ORAL 1200 MG, PER ORAL Date:06/10/98ISR Number: 3179919-8Report Type:Periodic Age:28 YR Gender:Male I/FU:I Outcome Dose Other 900 MG, PER Company Report #LITH002980002 PT Report Source Product Role Alopecia Consumer Lithonate Capsules PS Klonopin Prozac C C Amblyopia ORAL Dermatitis Faecal Incontinence Hallucination Hyperacusis Hyperglycaemia Paraesthesia Skin Discolouration Speech Disorder Urinary Incontinence Visual Field Defect 22-Aug-2005 Page: 48 Manufacturer Route Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/10/98ISR Number: 3179920-4Report Type:Periodic Age:50 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LITH002980003 PT Report Source Product Role Abdominal Pain Diarrhoea Health Professional Lithium Carbonate Capsules PS Manufacturer Route Duration ORAL UNK, PER ORAL Eosinophilia Oesophageal Stenosis Date:06/11/98ISR Number: 3092824-0Report Type:Direct Age:37 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG PO Initial or Prolonged Q.I.D., LONG PT Company Report # Report Source Nausea Product Role Lithium PS Sentraline Trazadone C C Manufacturer Route ORAL Tremor Visual Disturbance TERM Vomiting Date:06/11/98ISR Number: 3095962-1Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #17812-035 PT Report Source Product Role Manufacturer Alopecia Consumer Lithium PS Roxane Laboratories, Inc. Route Duration 4-5 MONTHS Date:06/11/98ISR Number: 3095972-4Report Type:Periodic Age:25 YR Gender:Female I/FU:I Outcome Dose Other 1 YR Company Report #17812-036 PT Report Source Product Role Manufacturer Dermatitis Exfoliative Consumer Lithium Carbonate PS Roxane Duration Route Tooth Disorder Date:06/11/98ISR Number: 3095975-XReport Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #17812-037 PT Report Source Product Role Manufacturer Route Drug Interaction Dysphagia Gait Disturbance Speech Disorder Consumer Lithium Carbonate Capsules Usp, 300 Mg-Roxane Laboratories, Inc. PS ORAL Haloperidol (Manufacturer Unknown) SS ORAL Duration 600 MG, BID, Visual Disturbance PO 5 MG OHS PO Date:06/11/98ISR Number: 3095978-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other 22-Aug-2005 Page: 49 Company Report #17812-038 PT Report Source Product Role Manufacturer Alopecia Health Professional Lithium PS Roxane Laboratories, Inc. Duration 10:48 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/98ISR Number: 3095980-3Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Other 300 MG TID, Company Report #17812-039 PT Report Source Product Role Manufacturer Route Muscle Twitching Health Lithium Carbonate PS Roxane ORAL Zoloft Atenolol Motrin Trazodone Premphase C C C C C Duration Professional PO Date:06/11/98ISR Number: 3095983-9Report Type:Periodic Age:64 YR Gender:Male I/FU:I Outcome Dose Other Company Report #17812-041 PT Report Source Product Role Manufacturer Route Drug Interaction Drug Level Above Health Professional Lithium PS Roxane Laboratories, Inc. ORAL Duration 300 MG TID, Therapeutic PO Lisinopril Niacin Date:06/11/98ISR Number: 3095985-2Report Type:Periodic Age:53 YR Gender:Male I/FU:I Outcome Dose Other SS C Company Report #17812-042 PT Report Source Product Role Manufacturer Route Drug Interaction Drug Level Above Health Professional Lithium PS Roxane Laboratories, Inc. ORAL Duration 300 MG TID, Therapeutic PO Lisinopril SS Ibuprofen Albuterol Lorazepam C C C 10 MG BID, PO ORAL Date:06/15/98ISR Number: 3093386-4Report Type:Direct Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600 MG QAM, Initial or Prolonged 900 MG QAM PO PT Company Report # Report Source Diabetes Insipidus Product Role Lithium PS Manufacturer Route ORAL Date:06/15/98ISR Number: 3094573-1Report Type:Expedited (15-DaCompany Report #1998014812-1 Age:59 YR Gender:Female I/FU:I Outcome Dose Other 1.0 DAILY PT Report Source Product Role Manufacturer Route Alopecia Health Eskalith PS Smithkline Beecham ORAL Asthenia Professional Buspar Inderal Cardura C C C Duration ORAL Dental Caries Diabetes Mellitus Feeling Drunk Goitre 22-Aug-2005 Page: 50 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/98ISR Number: 3094581-0Report Type:Expedited (15-DaCompany Report #1998012322-1 Age:54 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 450 Initial or Prolonged MILLIGRAMS PT Report Source Product Role Manufacturer Cardiomegaly Health Quilonorm PS Smithkline Beecham Pericardial Effusion Professional Antra Aspirin Seresta Valium C C C C Respiratory Disorder Respiratory Gas Exchange Disorder Route Date:06/15/98ISR Number: 3095083-8Report Type:Expedited (15-DaCompany Report #1998007501-1 Age:59 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 300 Initial or Prolonged MILLIGRAMS PT Report Source Product Role Cardiac Failure Health Eskalith PS Dyspnoea Professional Hydrochlorothiazide Plendil Atenolol Zocor Insulin C C C C C Manufacturer Route ORAL Pulmonary Oedema 3.0 DAILY Therapeutic Agent ORAL Toxicity Date:06/15/98ISR Number: 3095872-XReport Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose Other 900 MG PER Company Report #LBID002970015 PT Report Source Product Role Muscle Spasms Health Lithobid PS Manufacturer Route Duration Professional DAY, PER ORAL ORAL Date:06/15/98ISR Number: 3095877-9Report Type:Periodic Age:36 YR Gender:Male I/FU:I Outcome Dose Duration Other 1200 MG, PER Company Report #LBID002970017 PT Report Source Product Role White Blood Cells Urine Consumer Lithobid PS Claritin (Loratadine) C Manufacturer Route ORAL Positive DAY, PER ORAL Date:06/15/98ISR Number: 3095882-2Report Type:Periodic Age:11 YR Gender:Male I/FU:I Outcome Dose Duration Other 300,600,1200, Company Report #LBID002970025 PT Report Source Product Role Aggression Consumer Lithobid PS Cylert Imipramine Trazodone Wellbutrin C C C C Coordination Abnormal PER ORAL Diarrhoea Muscular Weakness Sedation Thirst Tremor Vomiting 22-Aug-2005 Page: 51 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/98ISR Number: 3095888-3Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Other PER ORAL PT Report Source Product Role Balance Disorder Health Lithobid PS Dizziness Professional Manufacturer Route Duration Date:06/15/98ISR Number: 3095891-3Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Other PER ORAL Company Report #LBID002970031 ORAL Company Report #LBID002970032 PT Report Source Product Role Manufacturer Route Balance Disorder Health Lithobid PS ORAL Dizziness Professional Depakote SS ORAL Duration PER ORAL Date:06/15/98ISR Number: 3095898-6Report Type:Periodic Age:16.5 YR Gender:Female I/FU:I Outcome Dose Other PER ORAL Company Report #LBID002970034 PT Report Source Product Role Manufacturer Route Galactorrhoea Health Lithobid PS ORAL Professional Paxil SS ORAL Duration 40 MG, PER ORAL Date:06/15/98ISR Number: 3095904-9Report Type:Periodic Age:75 YR Gender:Male I/FU:I Outcome Dose Other 600 MG, PER ORAL Company Report #LBID002970036 PT Report Source Product Role Aphasia Health Lithobid PS Confusional State Professional Manufacturer Route Duration ORAL Date:06/15/98ISR Number: 3095906-2Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Other PER ORAL PT Report Source Product Role Abnormal Sleep-Related Health Lithobid PS Event Professional Manufacturer Route Duration Date:06/15/98ISR Number: 3095910-4Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other 900 MG, PER Company Report #LBID002970038 ORAL Company Report #LBID002980001 PT Report Source Product Role Premature Ejaculation Health Lithobid PS Manufacturer Route Duration ORAL Professional ORAL Date:06/15/98ISR Number: 3095913-XReport Type:Periodic Age:39 YR Gender:Female I/FU:I Outcome Dose Other 900-1200 MG Company Report #LBID002980002 PT Report Source Product Role Disturbance In Attention Consumer Lithobid PS Prozac C Haematuria PER DAY, PER Memory Impairment ORAL Pyrexia Tremor 22-Aug-2005 Page: 52 Manufacturer Route Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/98ISR Number: 3095917-7Report Type:Periodic Age:59 YR Gender:Male I/FU:I Outcome Dose Other 300 MG, PER Company Report #LBID002980005 PT Report Source Product Role Anxiety Consumer Lithobid PS Micronase Synthroid C C Manufacturer Route Duration ORAL Asthenia ORAL Crying Decreased Appetite Depression Flatulence Heart Rate Increased Insomnia Mania Tachycardia Thinking Abnormal Tremor Date:06/15/98ISR Number: 3095920-7Report Type:Periodic Age:23 YR Gender:Male I/FU:I Outcome Dose Other 900 MG HS, Company Report #LBID002980011 PT Report Source Product Role Diarrhoea Health Lithobid PS Faeces Discoloured Professional Zyprexa C Manufacturer Route Duration ORAL PER ORAL Liver Function Test Abnormal Date:06/15/98ISR Number: 3095924-4Report Type:Periodic Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Other 900 MG, 1200 Company Report #LBID002980012 PT Report Source Product Role Asthenia Consumer Lithobid PS Claritin Klonopin C C Coordination Abnormal MG, PER ORAL Diarrhoea Fatigue Manufacturer Route ORAL Gastrointestinal Disorder Genital Pruritus Male Palpitations Date:06/16/98ISR Number: 3094517-2Report Type:Direct Age:54 YR Gender: I/FU:I Outcome Dose Duration Hospitalization 600MG QAM 300 Initial or Prolonged II QHS PT Drug Toxicity Date:06/18/98ISR Number: 3095298-9Report Type:Direct Age:71 YR Gender:Female I/FU:I 22-Aug-2005 Page: 53 10:48 AM C C Company Report # Report Source Product Role Lithium PS Indocin Lisinopril C C Mental Impairment Nausea Tremor Vomiting Outcome Hospitalization Initial or Prolonged Vancenase Aq Vicon PT Decreased Appetite Depression Drug Toxicity Hypercalcaemia Hypertension Insomnia Company Report # Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lethargy Myocardial Infarction Report Source Dose Product Role Lithium PS Nortriptyline Enalapril Hydralazine Digoxin C C C C Manufacturer Route Manufacturer Route Duration 300 MG AT HS; 600MG AT HS Date:06/22/98ISR Number: 3097185-9Report Type:Expedited (15-DaCompany Report #100632 Age:40 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 30 MG DAILY Initial or Prolonged ORAL PT Report Source Product Role Blindness Health Diazepam PS ORAL Zyprexia SS ORAL Paxil SS ORAL Lithium SS ORAL Vistaril SS ORAL Triazolam SS ORAL Tegretol SS ORAL Serzone C ORAL Professional Other 5 MG DAILY ORAL 20 MG DAILY ORAL 600 MG 2 X PER DAY ORAL ORAL ORAL 400 MG DAILY ORAL 250 MG DAILY ORAL Date:06/24/98ISR Number: 3097891-6Report Type:Expedited (15-DaCompany Report #17812-048 Age:40 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG BID PT Report Source Product Role Manufacturer Route Blindness Diabetes Mellitus Consumer Lithium PS Roxanne Laboratories, Inc ORAL Manufacturer Route Therapeutic Agent PO Toxicity Zyprexa Paxil Ciazepam Serzone Trazodone Vistaril C C C C C C Date:06/29/98ISR Number: 3099559-9Report Type:Expedited (15-DaCompany Report #LBID002980018 Age:77 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening PER ORAL Hospitalization Initial or Prolonged 22-Aug-2005 Page: 54 10:48 AM PT Report Source Product Role Drug Level Above Health Lithobid PS Therapeutic Hypovolaemia Lethargy Muscle Spasms Renal Failure Acute Therapeutic Agent Toxicity Professional Aspirin (Salicylic Acid) Cardura (Doxazosin Mesilate) Enoxaparin Vs Placebo (Heparin-Fraction, Sodium Salt) Norvasc (Amlodipine Besilate) C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ticlid (Ticlopidine Hydrochloride) Date:06/30/98ISR Number: 3100034-3Report Type:Direct Age:30 YR Gender:Female I/FU:I Outcome Dose Duration Death 300MG Q AM; Hospitalization 600MG Q HS Initial or Prolonged 20MG BID PT C Company Report # Report Source Product Role Lithium PS Convulsion Prozac SS Disseminated Haldol SS Intravascular Coagulation Cogentin SS Agitation Manufacturer Route Manufacturer Route Coma 5MG BID 2MG Q AM Hypotension Hypotonia Lactic Acidosis Multi-Organ Failure Muscle Rigidity Pulmonary Oedema Pyrexia Respiratory Failure Tremor Date:06/30/98ISR Number: 3100123-3Report Type:Expedited (15-DaCompany Report #100632 Age:40 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 30 MG DAILY Initial or Prolonged ORAL PT Report Source Product Role Blindness Health Diazepam PS ORAL Blood Cholesterol Professional Increased Other Zyprexa SS ORAL Paxil SS ORAL 5 MG DAILY Diabetes Mellitus ORAL Hyperlipidaemia 20 MG DAILY ORAL Lithium SS ORAL Tegretol SS ORAL Serzone SS ORAL Triazolam SS ORAL Vistaril SS ORAL 600 MG 2 X PER DAY ORAL 400 MG DAILY ORAL 250 MG DAILY ORAL ORAL ORAL Date:06/30/98ISR Number: 3100675-3Report Type:Expedited (15-DaCompany Report #1998016247-1 Age:71 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600 Initial or Prolonged MILLIGRAMS PT Report Source Product Role Manufacturer Route Blood Calcium Increased Health Lithium PS ORAL Blood Urea Increased Professional Lithium SS ORAL Lithium SS Nortriptline Enalapril Hydralazine Dicoxin C C C C Decreased Appetite 1.0 DAILY Depression ORAL 14 DAY Drug Toxicity 300 Fatigue MILLIGRAMS Hypercalcaemia 1.0 DAILY Hypertension ORAL UNKNOWN 22-Aug-2005 Page: 55 14 DAY Insomnia UNKNOWN Lethargy Myocardial Infarction 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/98ISR Number: 3108017-4Report Type:Expedited (15-DaCompany Report #9905149 Age:36 YR Gender:Female I/FU:F Outcome Dose Duration Death 500.000 MG PO Hospitalization QD Initial or Prolonged 800.000 MG PO PT Report Source Product Role Manufacturer Route Agitation Foreign Depakene PS ORAL Blood Thyroid Stimulating Health Hormone Increased Professional Lithium Carbonate SS ORAL Diazepam Clonazepam Flunitrazepam Hydroxyzine Hydrochlo Levomepromazine Tropatepine Hydrochlo C C C Bundle Branch Block Right UNK Electrocardiogram Normal Excitability Mania Date:07/06/98ISR Number: 3103976-8Report Type:Direct Age:61 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300 MG PO BID Initial or Prolonged - CHRONIC PT Report Source Acute Prerenal Failure Product Role Lithium PS Synthroid C Manufacturer Route Manufacturer Route Diarrhoea Date:07/06/98ISR Number: 3103979-3Report Type:Direct Age:57 YR Gender:Male I/FU:I PT Duration C Company Report # Dizziness Dysarthria Mental Impairment Pneumonia Pyrexia Outcome Dose C C Company Report # Report Source Product Role Hospitalization 300 MG AM, Initial or Prolonged 600 MG PM 3 WK Asthenia Lithium Carbonate PS Drug Level Above Prozac SS Therapeutic Lethargy Parkinsonian Gait Lescol Remeron Asa C C C Diarrhoea ORAL 60 MG PO QD Date:07/08/98ISR Number: 3104088-XReport Type:Direct Age: Gender:Male I/FU:I Outcome Dose PT Company Report # Report Source Product Role Allegra PS Lithium SS St. John'S Wort C Manufacturer Route Manufacturer Route Duration Nausea 60 MG QD 300 MG AM, 600 MG HS Date:07/13/98ISR Number: 3104710-8Report Type:Expedited (15-DaCompany Report #8-98188-058A Age:26 YR Gender: I/FU:I Outcome Dose Duration Hospitalization 2 GRAMS ORAL Initial or Prolonged 1.2 GRAM PT Report Source Product Role Bundle Branch Block Right Foreign Efexor PS Convulsion Health Lithium SS Hypertension Professional Zolpidem C 60 MG Overdose Tachycardia 22-Aug-2005 Page: 56 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/98ISR Number: 3108656-0Report Type:Direct Age:71 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600MG, 300MG Initial or Prolonged BI, ORAL PT Report Source Diabetes Insipidus Date:07/21/98ISR Number: 3108406-8Report Type:Direct Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization BID Initial or Prolonged BID Company Report # PT Product Role Lithium PS Manufacturer Route ORAL Company Report # Report Source Product Role Confusional State Lithium Carb PS Difficulty In Walking Divalproex Na SS Manufacturer Route Manufacturer Route Dysarthria Overdose Date:07/21/98ISR Number: 3109000-5Report Type:Direct Age:28 YR Gender:Female I/FU:I Outcome PT Dose Duration Life-Threatening Delirium INTRAVENOUS 0.625 MG Q Hospitalization Hyperhidrosis 3HR IVP Initial or Prolonged Hyperpyrexia 600 MG PO Required Muscle Rigidity BID: Intervention to THERAPY:YEARS Prevent Permanent Impairment/Damage Company Report # Report Source Product Role Droperidol PS Lithium SS Ceftriaxone Gentamicin Phenazopyridine C C C ORAL Date:07/21/98ISR Number: 3109005-4Report Type:Direct Age:62 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 450 MG PO HS Initial or Prolonged 80 MG QD PT Product Role Dehydration Lithium Sa PS Dizziness Lasix SS Fall Head Injury Hypovolaemia Acetominophen Clonidine Benztropine C C C Date:07/23/98ISR Number: 3109674-9Report Type:Direct Age:78 YR Gender:Female I/FU:I Outcome Dose Company Report # PT Report Source Route ORAL Company Report # Report Source Product Role Asthenia Lithium Carbonate PS Nausea Vomiting Buspar Inderal Maxzide Lisinopril Pepcid Oxybutynin Premarin C C C C C C C Manufacturer Route Duration 300MG TID PO 22-Aug-2005 Page: 57 Manufacturer 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/98ISR Number: 3109238-7Report Type:Expedited (15-DaCompany Report #1998018427-1 Age:81 YR Gender:Male I/FU:I Outcome Dose Other 625 PT Report Source Product Role Manufacturer Akathisia Foreign Lithium Carbonate PS Smithkline Beecham Anxiety Literature Product Role Manufacturer Ultram PS Lithium Carbonate SS Route Duration MILLIGRAMS Delirium Depression Drug Toxicity Date:07/27/98ISR Number: 3109820-7Report Type:Direct Age:19 YR Gender:Male I/FU:I Outcome Dose PT Company Report # Report Source Route Duration Renal Failure Acute ORAL 600MG PO BID Date:07/28/98ISR Number: 3109766-4Report Type:Expedited (15-DaCompany Report #.58-98 Age:39 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 30 MG/DAY PO Initial or Prolonged PT Report Source Product Role Convulsion Foreign Remeron PS Drug Interaction Health Professional Lithium Fluoxetine SS C Date:07/28/98ISR Number: 3112921-0Report Type:Direct Age:48 YR Gender: I/FU:I Outcome Dose Duration Life-Threatening 600 MG TWICE Hospitalization DAY PT Thyroid Gland Cancer Manufacturer Route ORAL Company Report # Report Source Product Role Lithium Carbonate PS Manufacturer Route Initial or Prolonged Disability Date:07/28/98ISR Number: 3113021-6Report Type:Direct Age:56 YR Gender:Female I/FU:I Outcome Dose Duration Required 300 MG, T1 Intervention to QHS, ORAL Prevent Permanent Impairment/Damage PT PT Agitation Delirium PO BID ;2AM 3 Mania HRS 2 BID; 2 AM 3 HS BAD 22-Aug-2005 Page: 58 10:48 AM Report Source Diabetes Insipidus Date:07/28/98ISR Number: 3113138-6Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Other 1T PO BID ;2 Company Report # Product Role Lithium Carbonate PS Manufacturer Route ORAL Company Report # Report Source Product Role Lithium PS Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/98ISR Number: 3111914-7Report Type:Expedited (15-DaCompany Report #9813535 Age:32 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening 450.00 MG Hospitalization TOTAL:BID:ORA Initial or Prolonged L Disability 10.00 MG Required TOTAL:DAILY:O Intervention to RAL Prevent Permanent 50.00 MG Impairment/Damage TOTAL:DAILY:O PT Report Source Product Role Abdominal Distension Foreign Lithane PS ORAL Apathy Health Aphasia Professional Thiothixene SS ORAL Sertraline SS ORAL Clonazepam Lorazepam Psyllium Fluoxetine Flurazepam Procyclidine Benzotropine C C C C C C C Confusional State Manufacturer Route Convulsion Diarrhoea Difficulty In Walking Dysphonia Hyperhidrosis RAL Hyponatraemia Joint Stiffness Muscle Rigidity Nausea Psychotic Disorder Skin Discolouration Therapeutic Agent Toxicity Tic Tremor Vomiting Date:08/03/98ISR Number: 3111547-2Report Type:Direct Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG PO TID Initial or Prolonged 0.5 MG PO BID PT Company Report # Product Role Coma Lithium Carbonate PS ORAL Drug Level Above Alprazolam SS ORAL Therapeutic Report Source Manufacturer Route Date:08/03/98ISR Number: 3226795-0Report Type:Periodic Age:55 YR Gender:Male I/FU:I Outcome Dose Other 15 MG HS, Company Report #97526.01 PT Report Source Product Role Manufacturer Route Personality Disorder Consumer Thiothixene Capsules PS Mylan ORAL Lithium SS Roxane ORAL Product Role Manufacturer Route Lithium PS Duration Salivary Hypersecretion ORAL 20 YR 600 MG AM AND 600 MG PM, ORAL 7 YR Date:08/05/98ISR Number: 3113740-1Report Type:Direct Age:56 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300MG PO QD Initial or Prolonged 22-Aug-2005 Page: 59 10:48 AM PT Accidental Overdose Apnoea Bradycardia Drooling Drug Toxicity Nystagmus Speech Disorder Company Report # Report Source ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/98ISR Number: 3114289-2Report Type:Expedited (15-DaCompany Report #1998019810-1 Age:62 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 450 MG 1.0 Initial or Prolonged DAILY ORAL PT Report Source Product Role Dehydration Health Lithium PS Dizziness Professional Acetaminophen Clonidine Warfarin Benztropine Lasix .. Potassium Chloride C C C C C C C Fall Head Injury Hypovolaemia Manufacturer Route ORAL Date:08/07/98ISR Number: 3114342-3Report Type:Expedited (15-DaCompany Report #9822838 Age: Gender:Female I/FU:I Outcome Dose Duration Required ORAL Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Hepatocellular Damage Consumer Lithane PS Manufacturer Route ORAL Date:08/07/98ISR Number: 3114362-9Report Type:Expedited (15-DaCompany Report #9823435 Age: Gender: I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Anaemia Foreign Lithane PS Health Professional Unspecified Psychiatric Drugs C Date:08/11/98ISR Number: 3115368-6Report Type:Expedited (15-DaCompany Report #D/98/02728/LEX Age:28 YR Gender:Female I/FU:I Manufacturer Route ORAL Outcome Dose Duration Hospitalization 400 MG ORAL Initial or Prolonged 1 G Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Hepatomegaly Health Leponex PS Influenza Like Illness Professional Lithium SS Recephin C Pericardial Effusion Pleural Effusion Pyrexia Rash Erythematous Manufacturer Route ORAL Date:08/12/98ISR Number: 3116034-3Report Type:Expedited (15-DaCompany Report #9823592 Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 50.00 MG Initial or Prolonged TOTAL:DAILY:O PT Report Source Product Role Manufacturer Route Congestive Cardiomyopathy Foreign Zoloft PS ORAL Dyspnoea Health Lithium SS ORAL Zopiclone Chlorpromazine C C Professional RAL Other 400.00 MG TOTAL:BID:ORA L 22-Aug-2005 Page: 60 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/13/98ISR Number: 3116797-7Report Type:Expedited (15-DaCompany Report #D/98/02728/LEX Age:28 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 600 MG ORAL Initial or Prolonged 100 MG ORAL Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Hepatomegaly Health Leponex PS ORAL Influenza Like Illness Professional Lithium SS ORAL Recephin C Juvenile Arthritis Leukocytosis Pericardial Effusion Pleural Effusion Pyrexia Rash Erythematous Manufacturer Route Date:08/14/98ISR Number: 3117160-5Report Type:Expedited (15-DaCompany Report #9726378 Age:57 YR Gender:Male I/FU:F Outcome Dose Duration Required 4.00MG Intervention to TOTAL:DAILY:O Prevent Permanent RAL Impairment/Damage 1350.00 PT Report Source Product Role Manufacturer Route Anger Health Cardura PS ORAL Drug Ineffective Professional Lithium SS ORAL Mania MGTOTAL:TID:O RAL Date:08/14/98ISR Number: 3117369-0Report Type:Expedited (15-DaCompany Report #9726378 Age:57 YR Gender:Male I/FU:F Outcome Dose Duration Required 4.00 MG Intervention to TOTAL: DAILY: PT Report Source Product Role Aggression Health Cardura PS Drug Toxicity Professional Manufacturer Route ORAL Prevent Permanent ORAL Impairment/Damage 1350.00 MG Mania Lithium SS ORAL TOTAL: TID: ORAL Date:08/14/98ISR Number: 3117388-4Report Type:Expedited (15-DaCompany Report #980810-107055343 Age:15 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Convulsion Consumer Topamax PS Lithium Fluoxetine Hydrochloride Loratadine Coenzyme Q SS Jaundice Tremor Date:08/20/98ISR Number: 3120098-0Report Type:Direct Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 2MG TID Initial or Prolonged 450MG BID PO PT Report Source Role Agitation Benztropine PS Delirium Lithium SS Halperidal C Disorientation 10:48 AM ORAL Company Report # LONG TERM 22-Aug-2005 Page: 61 Route C C C Product Drug Toxicity Hallucination, Visual Manufacturer Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/98ISR Number: 3120100-6Report Type:Direct Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 450MG BID Initial or Prolonged LONG TERM PT Company Report # Report Source Confusional State Product Role Lithium PS Manufacturer Route Manufacturer Route Drug Toxicity Lethargy Date:08/20/98ISR Number: 3120711-8Report Type:Periodic Age:57 YR Gender:Male I/FU:I Outcome Dose Other DAILY: ORAL Company Report #9726378 PT Report Source Product Role Anger Health Cardura PS ORAL Drug Effect Decreased Professional Lithium SS ORAL Duration 1350.00 MG Drug Interaction TOTAL:TID: Mania ORAL Date:08/24/98ISR Number: 3121188-9Report Type:Direct Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300 MG BID Initial or Prolonged PT Report Source Confusional State Product Role Lithium PS Manufacturer Route Manufacturer Route Drug Toxicity Mental Disorder Date:08/27/98ISR Number: 3122080-6Report Type:Direct Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization - Company Report # PT Drug Toxicity Company Report # Report Source Product Role Lithium PS Initial or Prolonged Metabolic Disorder Date:08/28/98ISR Number: 3123312-0Report Type:Direct Age:71 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 400/300 ALT Initial or Prolonged DAYS LONG PT Company Report # Report Source Mental Impairment Product Role Lithium PS Manufacturer Route Manufacturer Route Therapeutic Agent Toxicity TERM Date:08/31/98ISR Number: 3124066-4Report Type:Expedited (15-DaCompany Report #9826047 Age:1 DY Gender:Male I/FU:I Outcome Dose Duration Congenital Anomaly PT Report Source Product Role Complications Of Maternal Exposure To Therapeutic Drugs Multiple Congenital Abnormalities Foreign Health Professional Company Representative Zoloft Lithium PS SS Date:09/01/98ISR Number: 3124535-7Report Type:Expedited (15-DaCompany Report #9201/18276 Age:56 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization 22-Aug-2005 Page: 62 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Other Dose PT Report Source Product Role Coma Foreign Xanax PS Hypochloraemia Health Hyponatraemia Professional Lithium SS Company Paroxetine SS Manufacturer Route Duration ORAL .75 MG/DAY; ORAL UNKNOWN 20 MG /DAY Representative Date:09/02/98ISR Number: 3125908-9Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 10 MG Q AM PO Initial or Prolonged Company Report # PT Report Source Product Role Manufacturer Route Catatonia Health Olanzapine PS Lilly ORAL Confusional State Depressed Level Of Professional Lithium Carbonate (600 Mg, Roxane) SS Roxane ORAL Lorazepam C Manufacturer Route 600 MG BID PO Consciousness Disorientation Disturbance In Attention Dyskinesia Dystonia Leukocytosis Masked Facies Muscle Rigidity Neuroleptic Malignant Syndrome Psychotic Disorder Pyrexia Tachycardia Date:09/02/98ISR Number: 3126394-5Report Type:Direct Age:41 YR Gender:Female I/FU:I Outcome Dose PT Duration Company Report # Report Source Product Role Life-Threatening 300 MG TID Hospitalization 25 MG QID Initial or Prolonged 100 MG QHS Loss Of Consciousness Lithium PS Overdose Librium SS Elavil SS Cocaine Marijuana Serax C C C Date:09/03/98ISR Number: 3125581-XReport Type:Expedited (15-DaCompany Report #8-98243-055A Age:41 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged 22-Aug-2005 Page: 63 10:48 AM PT Report Source Product Role Drug Level Above Therapeutic Electrocardiogram Qt Prolonged Loss Of Consciousness Overdose Health Professional Serax Cocaine Lithium Marijuana Elavil Librium PS SS SS SS SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/04/98ISR Number: 3126293-9Report Type:Direct Age:15 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 100 MG PO QD 1 WK Initial or Prolonged 300 MG PO BID 1 WK PT Company Report # Report Source Product Role Manufacturer Route Anxiety Zoloft PS ORAL Diarrhoea Lithium SS ORAL Dyspnoea Electrocardiogram Abnormal Heart Rate Increased Panic Disorder Supraventricular Extrasystoles Tremor Date:09/04/98ISR Number: 3126307-6Report Type:Expedited (15-DaCompany Report #9826538 Age:59 YR Gender:Male I/FU:I Outcome Dose Duration Required 600.00 MG Intervention to TOTAL:ORAL 7 YR Prevent Permanent 200.00 MG Impairment/Damage TOTAL: EVERY PT Report Source Product Role Apathy Foreign Lithane PS Diarrhoea Literature Drug Level Above Health Clopixol SS Therapeutic Professional Dysarthria OTHER WEEK Lethargy Masked Facies Muscle Twitching Nephrotic Syndrome Oedema Oedema Peripheral Proteinuria Restlessness Tremor Manufacturer Route ORAL Date:09/04/98ISR Number: 3126309-XReport Type:Expedited (15-DaCompany Report #9826539 Age:77 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 625.00 MG Initial or Prolonged TOTAL; ORAL PT Report Source Product Role Manufacturer Route Confusional State Foreign Lithane PS ORAL Coordination Abnormal Literature Drug Toxicity Health Diazepam SS ORAL Dysarthria Professional Nifedipine SS ORAL Losartan SS ORAL Tamoxifen C 10.00 MG TOTAL; ORAL Hypertension 30.00 MG TOTAL; ORAL 50.00 MG TOTAL; ORAL Date:09/08/98ISR Number: 3127052-3Report Type:Expedited (15-DaCompany Report #9826537 Age:81 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 64 10:48 AM PT Atrial Fibrillation Confusional State Decreased Activity Drug Toxicity Electrocardiogram T Wave Inversion Fall FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Hypotension Memory Impairment Mucosal Dryness Report Source Product Role Respiratory Rate Literature Lithane PS Increased Health Sinus Bradycardia Professional Manufacturer Route Duration ORAL 300.00MG TOTAL DAILY ORAL Ventricular Extrasystoles Date:09/09/98ISR Number: 3126717-7Report Type:Expedited (15-DaCompany Report #LITH002980020 Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 1200 MG, PER Initial or Prolonged ORAL PT Report Source Product Role Agitation Literature Lithium Carbonate PS ORAL Trazodone SS ORAL Benztropine Paroxetine Perphenazine C C C Manufacturer Route Anxiety Blood Creatine 200 MG, PER Phosphokinase Increased ORAL Blood Iron Decreased Clonic Convulsion Coma Delirium Depressed Mood Disorientation Dysarthria Hypomania Muscle Rigidity Muscle Twitching Neuroleptic Malignant Syndrome Pyrexia Serotonin Syndrome White Blood Cell Count Increased Date:09/11/98ISR Number: 3127605-2Report Type:Expedited (15-DaCompany Report #9826907 Age:73 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Condition Aggravated Foreign Lithane PS Confusional State Coordination Abnormal Drug Toxicity Dysarthria Extrapyramidal Disorder Mania Muscle Rigidity Pneumonia Posturing Tremor Literature Health Professional Date:09/11/98ISR Number: 3128529-7Report Type:Expedited (15-DaCompany Report #9827177 Age:52 YR Gender:Female I/FU:I Outcome Death Hospitalization Initial or Prolonged Required Intervention to 22-Aug-2005 Page: 65 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage Dose PT Report Source Product Role Manufacturer Route Atherosclerosis Literature Lithane PS ORAL Bronchopneumonia Health Cardiomegaly Professional Amitriptyline SS ORAL Chlorpromazine SS ORAL Duration 600.00 MG TOTAL; BID; ORAL 5 YR Clonic Convulsion 50.00 MG Clostridium Colitis TOTAL; DAILY; Coma ORAL Confusional State 50 TOTAL; Drug Toxicity DAILY; ORAL Haemodialysis Hypertension Lethargy Metabolic Acidosis Pancreatitis Chronic Pyelonephritis Chronic Pyrexia Renal Impairment Date:09/11/98ISR Number: 3128676-XReport Type:Expedited (15-DaCompany Report #9827180 Age:29 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600.00 MG Initial or Prolonged TOTAL: ORAL Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Goitre Foreign Lithane PS Hyperthyroidism Literature Irritability Palpitations Thyroid Function Test Abnormal Weight Decreased Health Professional Manufacturer Route ORAL Date:09/13/98ISR Number: 3244846-4Report Type:Periodic Age:20 YR Gender:Female I/FU:I Outcome Dose Duration Other 100 MG TWICE Company Report #8-97329-003L PT Report Source Product Role Drug Interaction Health Minocycline Capsules PS Drug Level Changed Professional Lithium SS DAILY ORAL 900 MG 1,050 MG DAILY Date:09/15/98ISR Number: 3129164-7Report Type:Expedited (15-DaCompany Report #9827177 Age:52 YR Gender:Female I/FU:F Outcome Death Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 66 10:48 AM PT Atherosclerosis Bronchopneumonia Cardiomegaly Clonic Convulsion Clostridium Colitis Coma Confusional State Depressed Level Of Consciousness Drug Toxicity Haemodialysis Heart Rate Increased Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Hypertension Lethargy Metabolic Acidosis Report Source Product Role Pancreatitis Chronic Literature Lithane PS ORAL Pyelonephritis Chronic Health Pyrexia Professional Amitriptyline SS ORAL Chlorpromazine SS ORAL Manufacturer Route Duration 600.00 MG TOTAL:BID:ORA L 5 YR Renal Impairment 50.00 MG TOTAL:DAILY:O RAL 50.00 TOTAL:DAILY:O RAL Date:09/16/98ISR Number: 3130017-9Report Type:Expedited (15-DaCompany Report #8-98252-023A Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 240 MG DAILY Initial or Prolonged ORAL PT Report Source Product Role Blood Creatinine Literature Verelan PS ORAL Aspirin SS ORAL Lithium SS ORAL Zestril (Lisinopril) SS ORAL Manufacturer Route Increased Confusional State 325 MG DAILY Drug Interaction ORAL Drug Level Above 900 MG DAILY Therapeutic ORAL Dysarthria 10 MG DAILY Haemodialysis ORAL Mental Impairment Neurotoxicity Date:09/16/98ISR Number: 3130054-4Report Type:Expedited (15-DaCompany Report #9827587 Age: Gender:Male I/FU:I Outcome Dose Duration Required ORAL Intervention to ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Pollakiuria Consumer Lithane PS ORAL Navane SS ORAL Renal Impairment Date:09/18/98ISR Number: 3131905-XReport Type:Direct Age:81 YR Gender:Female I/FU:I Outcome Dose Duration Required 1 BID Intervention to Prevent Permanent Impairment/Damage Outcome Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Report Source Product Role Drug Effect Decreased Health Lithium Carbonate PS Professional 22-Aug-2005 Page: 67 10:48 AM PT Blood Pressure Fluctuation Bradycardia Deep Vein Thrombosis Hypotension Pulse Abnormal Pulse Absent Route Company Report # PT Date:09/22/98ISR Number: 3133135-4Report Type:Direct Age: Gender:Female I/FU:I Manufacturer Company Report # Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Arrest Report Source Dose Product Role Manufacturer Route Lithium Carbonate PS ORAL Atenolol SS ORAL Xanax Theragran Pepcid Colace Tegretol C C C C C Duration 300MG TID PO 25MG ALTERNATING 50MG QD PO Date:09/22/98ISR Number: 3134271-9Report Type:Expedited (15-DaCompany Report #980915-008013484 Age:43 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Agitation INTRAMUSCULAR 5 MG UNKNOWN Initial or Prolonged Blood Creatine IM Phosphokinase Increased (INTRAMUSCULA Depressed Level Of R) Consciousness UNKNOWN UNKNOWN Disorientation Drug Level Above Therapeutic Drug Toxicity Electrocardiogram T Wave Inversion Electrolyte Imbalance Hypokalaemia Myocardial Infarction Myocardial Ischaemia Sedation Report Source Product Role Foreign Haloperidol PS Lithium SS Naloxone Glucose C C Literature Health Professional Manufacturer Route Date:09/22/98ISR Number: 3232523-5Report Type:Periodic Age:34 YR Gender:Female I/FU:I Outcome Dose Other 2.00 MG Company Report #9728953 PT Report Source Product Role Manufacturer Route Abdominal Pain Consumer Navane Capsules PS ORAL Blood Prolactin Increased Prozac SS ORAL Chills Lithium SS ORAL Diabetes Mellitus Aleve SS ORAL Eye Pain Galactorrhoea Gastrointestinal Disorder Libido Decreased Libido Increased Nausea Palpitations Sedation Thyroid Disorder Vaginal Infection Visual Disturbance Weight Increased Klonopin Lorazepam C C Duration Albuminuria TOTAL; DAILY; Anorectal Disorder ORAL DAILY; ORAL 600.00 MG Cough TOTAL; Depression DAILY; ORAL DAILY; ORAL 22-Aug-2005 Page: 68 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/98ISR Number: 3133948-9Report Type:Direct Age:65 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Company Report # Report Source Confusional State Dehydration Drug Level Above Therapeutic Hypernatraemia Nephrogenic Diabetes Insipidus Product Role Lithium PS Manufacturer Route Manufacturer Route Date:09/24/98ISR Number: 3134672-9Report Type:Expedited (15-DaCompany Report #9828720 Age:51 YR Gender:Female I/FU:I Outcome Dose Disability 50.00 MG PT Report Source Product Role Difficulty In Walking Foreign Zoloft PS ORAL Pain In Extremity Consumer Lithium SS ORAL Paroxetin Unspecified Hormone C C Duration TOTAL ORAL Tachycardia ORAL Date:09/30/98ISR Number: 3136894-XReport Type:Direct Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1 PO TID Initial or Prolonged 1 PO TID PT Company Report # Product Role Abnormal Sleep-Related Lithium PS ORAL Event Lisinopril SS ORAL Bradycardia Dizziness Drug Toxicity Extrapyramidal Disorder Report Source Manufacturer Route Date:09/30/98ISR Number: 3232810-0Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #18558-005 PT Report Source Product Role Manufacturer Route Abdominal Pain Health Professional Lithium Carbonate Tablets Usp, 300 Mg -Roxane Laboratories, Inc. PS Roxane Laboratories, Inc. ORAL Manufacturer Route Duration 300 MG BID PO Ativan Acetaminophen Cogentin Imodium Haldol Sinequan Ambien Compazine Date:09/30/98ISR Number: 3232813-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other 22-Aug-2005 Page: 69 Company Report #18558-006 PT Report Source Product Hypertonia Speech Disorder Health Professional Lithium Carbonate Tablets Usp, 300mg Roxane Laboratories, Duration 10:48 AM C C C C C C C C Role FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc. PS Roxane Laboratories, Inc. ORAL 300 MG TID PO Keflex Phenobarbital Percocet Restoril Catapres Compazine Mvi Motrin Monistat Date:09/30/98ISR Number: 3232817-3Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other C C C C C C C C C Company Report #18558-007 PT Report Source Product Role Manufacturer Route Hyperhidrosis Health Professional Lithium Carbonate Tablets Usp, 300 Mg -Roxane Laboratories, Inc. PS Roxane Laboratories, Inc. ORAL Manufacturer Route Duration 450 MG BID PO Paxil Nortriptyline Antabuse Date:10/01/98ISR Number: 3260867-XReport Type:Periodic Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage C C C Company Report #001-0073-980091 PT Report Source Product Role Coordination Abnormal Nystagmus Health Professional Dilantin (Phenytoin Sodium) Lithium Sertraline Lisinopril PS SS C C Date:10/05/98ISR Number: 3138121-6Report Type:Expedited (15-DaCompany Report #9822838 Age: Gender:Female I/FU:F Outcome Dose Duration Required ORAL Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Ear Infection Consumer Lithane PS Route ORAL Hepatocellular Damage Hypersensitivity Weight Increased Date:10/09/98ISR Number: 3140424-6Report Type:Direct Age:74 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300MG ORAL Initial or Prolonged BID Manufacturer PT Company Report # Product Role Lithium PS ORAL Drug Toxicity Lisinopril 10mg SS ORAL Irritability Nephrogenic Diabetes Insipidus Ceftin Asa Biaxin C C C ORAL Renal Failure Acute Lorazepam Olanzepine Cozaar C C C Confusional State Report Source Manufacturer Route Disorientation 10MG ORAL QD 500MG QD 22-Aug-2005 Page: 70 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/98ISR Number: 3142413-4Report Type:Direct Age:30 YR Gender:Male I/FU:I Outcome Dose Duration Death TRIFLU 10 MG PT Company Report # Report Source Body Temperature Product Role Manufacturer Trifluoperazine PS Zyprexa Lithium SS Route Increased BID Circulatory Collapse ZYPREXA 10 MG Drug Toxicity 1 HS Neuroleptic Malignant Syndrome Petechiae Date:10/15/98ISR Number: 3142517-6Report Type:Expedited (15-DaCompany Report #98--10853 Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization DAILY, ORAL Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Toxic Skin Eruption Foreign Anafranil PS ORAL Health Teralithe SS ORAL Professional Depamide SS ORAL ORAL Other Date:10/16/98ISR Number: 3143074-0Report Type:Expedited (15-DaCompany Report #USA/98/02387/LEX Age:23 YR Gender:Female I/FU:I Outcome Dose Other 25 MG ORAL PT Report Source Product Role Drug Interaction Health Clozaril PS Renal Failure Acute Professional Lithium Zyprexa SS C Manufacturer Route Duration ORAL Date:10/16/98ISR Number: 3143084-3Report Type:Expedited (15-DaCompany Report #1046825A Age:74 YR Gender: I/FU:I Outcome Dose Death PO PT Report Source Product Role Manufacturer Route Analgesic Drug Level Literature Acetaminophen PS ORAL Above Therapeutic Health Lithium SS ORAL Completed Suicide Intentional Misuse Professional Duration PO Date:10/16/98ISR Number: 3143327-6Report Type:Direct Age:27 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 8 MG Disability 300 MG Required Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Product Role Delirium Tremens Perphenazine PS Hallucination Lithotabs SS Muscular Weakness Urticaria Benztropine C Manufacturer Route Manufacturer Route Date:10/19/98ISR Number: 3143367-7Report Type:Expedited (15-DaCompany Report #8-98280-099A Age: Gender:Female I/FU:I Outcome Dose Duration Required ORAL Intervention to ORAL Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 71 10:48 AM PT Report Source Product Role Drug Interaction Foreign Effexor PS ORAL Drug Toxicity Health Lithium SS ORAL Professional FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/98ISR Number: 3143368-9Report Type:Expedited (15-DaCompany Report #8-98243-055A Age:41 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening DOSE UNKNOWN Hospitalization ORAL Initial or Prolonged Other 100 MG AT PT Report Source Product Role Drug Level Above Health Serax PS Therapeutic Professional Cocaine Elavil SS SS Librium SS Lithium SS Marijuana C Electrocardiogram Abnormal Manufacturer Route ORAL Electrocardiogram Qt BEDTIME, Prolonged OVERDOSE Loss Of Consciousness AMOUNT Overdose 25 MG FOUR Toxicologic Test Abnormal TIMES DAILY, OVERDOSE AMOUNT 300 MG THREE TIMES DAILY, OVERDOSE AMOUNT Date:10/19/98ISR Number: 3143529-9Report Type:Direct Age:75 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization PO QD 450MG Initial or Prolonged M-F CHONIC PT Confusional State Drug Toxicity Company Report # Report Source Product Role Eskalith Cr PS Manufacturer Route ORAL Fall Thirst Tremor Date:10/19/98ISR Number: 3144247-3Report Type:Direct Age:76 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG PO Initial or Prolonged TID PT Ambiem Clonazepam Company Report # Report Source Abnormal Behaviour Date:10/19/98ISR Number: 3144252-7Report Type:Direct Age:51 YR Gender:Male I/FU:I PT Confusional State 10:48 AM Role Lithium Carbonate PS Folate Tylenol Levothyroxine Thiamine C C C C Manufacturer Route ORAL Company Report # Report Source Product Role Lithium Carbonate PS Ec Asa Dilantin Multivitamins Propranolol Sr Valproic Acid Darvocet Milk Of Magnesia Naproxen Haldol C C C C C C C C C Coordination Abnormal Drug Level Above Therapeutic Dysarthria Lethargy Mental Impairment Motor Dysfunction Muscular Weakness 22-Aug-2005 Page: 72 Product Aggression Agitation Drug Toxicity Nephrogenic Diabetes Insipidus Oral Intake Reduced Pseudomonas Infection Outcome Dose Duration Hospitalization 900 MG PO Initial or Prolonged BID C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydroxyzine Benztropine Folate Apap Antabuse Thiamine Nitropatch Date:10/19/98ISR Number: 3144352-1Report Type:Direct Age: Gender: I/FU:I Outcome Dose Other PT C C C C C C C Company Report # Report Source Product Role Manufacturer Route Lithium Citrate PS Rokane Manufacturer Route Route Duration Medication Error Date:10/19/98ISR Number: 3266340-7Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 300 MG TID Initial or Prolonged 25 MG QID Company Report # PT Report Source Product Role Loss Of Consciousness Overdose Health Professional Lithium 300 Mg Tid Librium 25 Mg Qid PS Librium SS 25 Mg Qid Elavil 100mg Qhs Cocaine Marijuana Serax SS C C C Date:10/23/98ISR Number: 3146058-1Report Type:Expedited (15-DaCompany Report #1998024871-1 Age:52 YR Gender:Female I/FU:I Outcome Dose Duration Death 600 Hospitalization MILLIGRAMS 5 YR Initial or Prolonged PT Report Source Product Role Manufacturer Atherosclerosis Literature Lithium PS Smithkline Beecham Blood Creatinine Health Increased Bronchopneumonia Professional Cardiomegaly Cerebellar Atrophy Clonic Convulsion Clostridium Colitis Coma Depressed Level Of Consciousness Drug Level Above Therapeutic Electroencephalogram Abnormal Gliosis Haemodialysis Metabolic Acidosis Metabolic Encephalopathy Pancreatitis Chronic Pyelonephritis Pyrexia Renal Impairment Stupor Therapeutic Agent Toxicity 22-Aug-2005 Page: 73 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/98ISR Number: 3244249-2Report Type:Periodic Age:71 YR Gender:Male I/FU:I Outcome Dose Other 50.00 MG Company Report #9820966 PT Report Source Product Role Manufacturer Route Asthenia Consumer Viagra Tablets PS ORAL Eskalith SS ORAL Cardura Allegra Flonase Atrovent C C C C Duration Tremor TOTAL; PRN; ORAL 675.00 MG TOTAL; BID; ORAL Date:10/28/98ISR Number: 3148754-9Report Type:Expedited (15-DaCompany Report #9905149 Age:36 YR Gender:Female I/FU:F Outcome Dose Duration Death 500.000 MG PO Hospitalization QD Initial or Prolonged 800.000MG PO PT Report Source Product Role Manufacturer Route Agitation Foreign Depakene PS Abbott ORAL Blood Thyroid Stimulating Health Hormone Increased Professional Lithium Carbonate SS Diazepam Clonazepam Flunitrazepam Dipotassium Clorazepa Hydroxyzine Hl Levomepromazine Tropatepine Hydrochlo C C C Bundle Branch Block Electrocardiogram Normal Excitability C C C C ORAL Date:10/28/98ISR Number: 3149112-3Report Type:Direct Age:13 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 1G BID PO Initial or Prolonged 600AM 450PM PT Company Report # Report Source Product Role Abdominal Pain Depakote PS ORAL Laboratory Test Abnormal Lithium SS ORAL Hepatitis B Vax #2 10/9/98 C Pancreatitis PO Vomiting Date:10/28/98ISR Number: 3149282-7Report Type:Expedited (15-DaCompany Report #1998025073-1 Age:25 YR Gender:Female I/FU:I Outcome Other 22-Aug-2005 Page: 74 PT Abortion Induced Angiopathy Cardiac Septal Defect Complications Of Maternal Exposure To Therapeutic Drugs Congenital Cystic Kidney Disease Ear Disorder Placental Disorder Pregnancy Renal Agenesis Talipes 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Transposition Of The Great Vessels Tricuspid Valve Report Source Product Role Manufacturer Incompetence Literature Lithium PS Smithkline Beecham Clozapine C Route Duration 900 MILLIGRAMS Date:10/28/98ISR Number: 3149432-2Report Type:Expedited (15-DaCompany Report #1998025220-1 Age:26 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Blood Sodium Decreased Drug Toxicity Feeling Drunk Hyperhidrosis Malaise Tremor Weight Increased Literature Health Professional Lithium Clonazepam Thiothixene PS C C Smithkline Beecham Product Role Manufacturer Route Lithium PS Manufacturer Route Duration Date:10/29/98ISR Number: 3149778-8Report Type:Direct Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600AM, 300AM, Initial or Prolonged 300PM PT Company Report # Report Source Polydipsia Polyuria Tremor Date:10/30/98ISR Number: 3149759-4Report Type:Direct Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600MG PO BID PT Agitation Company Report # Report Source Product Role Lithium PS ORAL Initial or Prolonged >6MONTHS 6 MON Required 20MG PO BID Intervention to < 1 MONTH Prevent Permanent Impairment/Damage Bradycardia Dialysis Lisinopril SS Lopcessor Pepcid Lasix Ecasa Atrovent Ntg Tonazepam Carbanafepine Septra C C C C C C C C C Drug Toxicity Electrocardiogram T Wave Inversion Hypotension Mental Impairment Renal Failure Acute Speech Disorder Tremor Date:10/30/98ISR Number: 3150119-0Report Type:Expedited (15-DaCompany Report #1998025218-1 Age:81 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 75 10:48 AM PT Blood Disorder Confusional State Drug Level Above Therapeutic Drug Toxicity Electrocardiogram Abnormal Memory Impairment ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Metabolic Disorder Mucosal Dryness Sinus Bradycardia Report Source Product Role Manufacturer Route Ventricular Extrasystoles Literature Lithium Carbonate PS Smithkline Beecham ORAL Manufacturer Route Duration 1200 Health MILLIGRAMS Professional ORAL Date:10/30/98ISR Number: 3150128-1Report Type:Expedited (15-DaCompany Report #B011992 Age:60 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening 50 MG ORAL Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Antinuclear Antibody Foreign Capoten PS ORAL Positive Health Lithium SS ORAL Ascites Cardiac Failure Drug Toxicity Hypertensive Crisis Oedema Pericardial Effusion Pleural Effusion Renal Failure Systemic Lupus Erythematosus Professional Other Levomepromazine Haloperidol C C Date:10/30/98ISR Number: 3150169-4Report Type:Expedited (15-DaCompany Report #9834295 Age:70 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 50.00 MG Initial or Prolonged TOTAL:DAILY:O RAL PT Report Source Product Role Drug Level Above Foreign Zoloft PS Therapeutic Health Liver Function Test Professional Manufacturer Route ORAL UNKNOWN Abnormal 750.00 MG Renal Failure Company Lithium SS Viloxazine C Representative TOTAL:DAILY Serotonin Syndrome Date:11/02/98ISR Number: 3150654-5Report Type:Direct Age:45 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 25 YR Initial or Prolonged Company Report # PT Report Source Product Role Confusional State Health Lithium PS Diarrhoea Drug Toxicity Dysphemia Tremor Professional Benztropine Cyclobenzaprine Mg Ox Folate Epivir Retrovir Crixtivan Dapsone Zyprexa Apap C C C C C C C C C C Date:11/03/98ISR Number: 3151834-5Report Type:Expedited (15-DaCompany Report #1998025889-1 Age:77 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 76 10:48 AM PT Akinesia Atrophy Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Brain Scan Abnormal Confusional State Coordination Abnormal Dose Report Source Product Role Manufacturer Literature Lithium Parsoxetine PS C Smithkline Beecham Route Duration Dehydration Depression Drug Level Above Therapeutic Hyperhidrosis Hyperreflexia Hypertension Pyrexia Sedation Date:11/03/98ISR Number: 3152506-3Report Type:Expedited (15-DaCompany Report #1998025999-1 Age:84 YR Gender:Female I/FU:I Outcome Dose Disability UNKNOWN PT Report Source Product Role Manufacturer Fall Literature Lithium Carbonate PS Smithkline Beecham Gait Disturbance Health Masked Facies Professional Manufacturer Route Duration 600 MILLIGRAMS UNKNOWN 4 YR Muscle Rigidity Parkinsonism Tremor Date:11/04/98ISR Number: 3151753-4Report Type:Expedited (15-DaCompany Report #9834501 Age:85 YR Gender:Female I/FU:I Outcome Dose Duration Required Intervention to 200.00 MG Prevent Permanent TOTAL: DAILY: Impairment/Damage ORAL PT Report Source Product Role Blood Creatinine Increased Health Professional Trovafloxacin Tablets PS ORAL Lithium SS ORAL Nephritis Proteinuria Renal Tubular Acidosis ORAL Route Relafen Prilosec C C Date:11/05/98ISR Number: 3152585-3Report Type:Expedited (15-DaCompany Report #LITH002980026 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization PER ORAL Initial or Prolonged PT Report Source Product Role Cerebrovascular Accident Health Lithium Carbonate PS Therapeutic Agent Toxicity Professional Date:11/10/98ISR Number: 3155599-2Report Type:Expedited (15-DaCompany Report #1998025887-1 Age:58 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 77 10:48 AM PT Agitation Blood Creatinine Increased Blood Pressure Increased Blood Urea Decreased Clonic Convulsion Confusional State Dehydration Depressed Level Of Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Consciousness Drug Toxicity Dysarthria Electrocardiogram Qt Dose Report Source Product Role Manufacturer Literature Lithium Bisoprolol Dosulepin L-Thyroxine (Levothyroxine Sodium) Viloxazine PS C C Smithkline Beecham Route Duration Prolonged Electrocardiogram T Wave Inversion Hypernatraemia Hypertension Hypertonia Hypothyroidism Muscle Contractions Involuntary Nephrogenic Diabetes Insipidus Oral Intake Reduced Polydipsia Polyuria Reflexes Abnormal Renal Impairment Skin Disorder Tongue Disorder Tremor C C Date:11/10/98ISR Number: 3155640-7Report Type:Expedited (15-DaCompany Report #1998026259-1 Age:65 YR Gender:Female I/FU:I Outcome Dose Duration Death Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Cardiac Arrest Condition Aggravated Drug Toxicity Parkinson'S Disease Literature Health Professional Lithium Frusemide PS C Smithkline Beecham Route Date:11/10/98ISR Number: 3155651-1Report Type:Expedited (15-DaCompany Report #S98-FRA-00759-01 (-0) Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 20 MG DAILY, Initial or Prolonged PO PT Report Source Product Role Drug Level Above Foreign Seropram PS Therapeutic Health Manufacturer Route ORAL Disability Renal Impairment Serotonin Syndrome Professional Lithium Date:11/10/98ISR Number: 3155736-XReport Type:Expedited (15-DaCompany Report #1998025215-1 Age:70 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 78 10:48 AM PT Acute Respiratory Distress Syndrome Blood Antidiuretic Hormone Decreased Diabetes Insipidus Gastric Ulcer Haemorrhage Glycosuria Hyperglycaemic Hyperosmolar Nonketotic Syndrome Hypernatraemia Pancreatitis Polyuria SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Embolism Urine Osmolarity Increased Dose Report Source Product Role Manufacturer Literature Lithium Carbonate PS Smithkline Beecham Amoxipine C Route Duration 1200 Health MILLIGRAMS Professional Date:11/10/98ISR Number: 3155737-1Report Type:Expedited (15-DaCompany Report #1998025922-1 Age:55 YR Gender: I/FU:I Outcome Dose Duration Hospitalization 1000 Initial or Prolonged MILLIGRAMS 40 YR PT Report Source Product Role Manufacturer Cardiac Failure Literature Lithium Carbonate PS Smithkline Beecham Manufacturer Route Cardiomegaly Cardiomyopathy Drug Toxicity Ejection Fraction Abnormal Electrocardiogram Abnormal Pleural Effusion Date:11/10/98ISR Number: 3155822-4Report Type:Expedited (15-DaCompany Report #1998026425-1 Age:23 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Renal Failure Acute Health Professional Lithium Clozaril (Clozapine) Clozaril (Clozapine) Zyprexa (Olanzapine) PS C C C Duration Date:11/10/98ISR Number: 3155944-8Report Type:Expedited (15-DaCompany Report #1998025921-1 Age:42 YR Gender:Female I/FU:I Route Outcome Dose Duration Hospitalization 750 Initial or Prolonged MILLIGRAMS PT Report Source Product Role Atrioventricular Block Literature Lithium Carbonate PS Manufacturer Route ORAL Complete Bradycardia ORAL Cardiac Disorder Drug Toxicity Sinus Arrhythmia Syncope Tachycardia Date:11/12/98ISR Number: 3156881-5Report Type:Expedited (15-DaCompany Report #8-98309-134A Age:74 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged SINGLE DOSE ORAL 22-Aug-2005 Page: 79 10:48 AM PT Report Source Product Role Manufacturer Route Drug Interaction Foreign Efexor PS ORAL Drug Level Above Health Lithium SS ORAL Therapeutic Professional FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/98ISR Number: 3157131-6Report Type:Expedited (15-DaCompany Report #WAES 98110032 Age:87 YR Gender:Female I/FU:I Outcome Dose Duration Other 500 MG/ BID / PT Report Source Product Role Abdominal Pain Health Dolobid PS Diarrhoea Professional Lithiumco3 SS L-Thyroxine Aspirin Clonazepam C C C Manufacturer Route ORAL PO Drug Interaction 150 MG / BID Drug Level Above / UNK Therapeutic Memory Impairment Mental Disorder Date:11/12/98ISR Number: 3158330-XReport Type:Expedited (15-DaCompany Report #1998027317-1 Age:48 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Biopsy Kidney Abnormal Fibrosis Nephritis Interstitial Renal Failure Renal Impairment Renal Tubular Atrophy White Blood Cell Disorder Literature Health Professional Lithium Tricyclic Antidepressants Truxal PS Smithkline Beecham Route Duration C C Date:11/13/98ISR Number: 3157030-XReport Type:Expedited (15-DaCompany Report #D/98/04349/LEX Age:46 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 500MG ORAL Initial or Prolonged 600MG Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Dystonia Study Leponex PS Posture Abnormal Health Hypnorex SS Professional Bifiteral Sostril C C Manufacturer Route ORAL Date:11/13/98ISR Number: 3157119-5Report Type:Expedited (15-DaCompany Report #1046825A Age:74 YR Gender:Female I/FU:F Outcome Death 22-Aug-2005 Page: 80 PT Abdominal Pain Acidosis Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Bicarbonate Decreased Blood Creatinine Increased Blood Glucose Increased Cardiovascular Disorder Coma Completed Suicide Confusional State Decreased Appetite Disorientation Dizziness Encephalopathy 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Haematochezia Heart Rate Increased Hepatorenal Syndrome Report Source Product Role Intentional Misuse International Normalised Ratio Increased Literature Health Professional Unknown Acetaminophen Product PS ORAL Lithium SS ORAL Tamoxifen C Manufacturer Route Duration UNKNOWN DOSE, Pco2 Decreased PO Respiratory Rate UNKNOWN DOSE, Increased PO Date:11/16/98ISR Number: 3158459-6Report Type:Expedited (15-DaCompany Report #1998027107-1 Age:21 YR Gender:Male I/FU:I Outcome Dose Duration Death ORAL Hospitalization 2.0 DAILY Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Death Health Thorazine PS Smithkline Beecham ORAL Professional Lithium SS Ativan Artane Prolixin Restoril Loxitane C C C C C Date:11/16/98ISR Number: 3281161-7Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other ORAL Company Report #9822120 PT Report Source Product Role Manufacturer Route Drug Ineffective Consumer Sinequan Capsules PS ORAL Zoloft SS ORAL Duration Insomnia 50.00 MG ORAL Nervousness TOTAL:DAILY:O RAL Lithium SS Macrobid Urecholine C C ORAL ORAL Date:11/19/98ISR Number: 3159408-7Report Type:Expedited (15-DaCompany Report #LITH002980027 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 750 MG PER Initial or Prolonged ORAL PT Report Source Product Role Anorexia Foreign Lithium Carbonate PS Blood Calcium Increased Literature Blood Magnesium Decreased Blood Parathyroid Hormone Increased Calcium Metabolism Disorder Calculus Urinary Cholelithiasis Hyperparathyroidism Nausea Renal Colic Thyroid Adenoma Vomiting Weight Decreased 22-Aug-2005 Page: 81 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/98ISR Number: 3160266-5Report Type:Expedited (15-DaCompany Report #1998027185-1 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 750 Initial or Prolonged MILLIGRAMS 10 YR Other PT Report Source Product Role Manufacturer Blood Calcium Increased Literature Lithium PS Smithkline Beecham Product Role Manufacturer Route Lithobid Risperidal Cogentin Tylenol PS C C C Manufacturer Route Blood Parathyroid Hormone Blood Parathyroid Hormone Increased Calculus Bladder Cholelithiasis Hyperparathyroidism Parathyroid Tumour Benign Renal Colic Thyroid Adenoma Date:11/19/98ISR Number: 3160944-8Report Type:Direct Age:19 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Company Report # Report Source Drug Toxicity Intentional Misuse Suicide Attempt Date:11/19/98ISR Number: 3275971-XReport Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 112.5 DAILY Initial or Prolonged REDUCED TO Route Company Report #8-98212-048A PT Report Source Product Role Depression Health Effexor Xr Capsules PS Hypertonia Professional Alcohol Eskalith Cr SS Myalgia 37.5 MG TWICE DAILY ORAL ORAL (Lithium) Extended Release Capsule SS Alcohol Eskalith Cr Estratest Provera Restoril C C C C C ORAL 450 MG TWICE DAILY ORAL Date:11/19/98ISR Number: 3280545-0Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Other Company Report #0936843A PT Report Source Product Role Manufacturer Route Drug Interaction Leukocytosis Health Professional Motrin (Ibuprofen) Product PS ORAL Lithium SS ORAL Duration UNKNOWN DOSE, PO UNKNOWN DOSE, PO 22-Aug-2005 Page: 82 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/98ISR Number: 3162338-8Report Type:Expedited (15-DaCompany Report #1998027337-1 Age:76 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 800 Other MILLIGRAMS; PT Report Source Product Role Manufacturer Amnesia Cerebral Atrophy Foreign Literature Lithium Carbonate Smithkline Beecham PS Smithkline Beecham Clonic Convulsion Health Dementia Professional Haloperidol C Route 600 Disorientation MILLIGRAMS 9 YR Disturbance In Attention Drug Level Above Therapeutic Drug Toxicity Dysarthria Dysphagia Gait Disturbance Hypothyroidism Tremor Date:11/24/98ISR Number: 3163509-7Report Type:Expedited (15-DaCompany Report #98HQ-10404 Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Serotonin Syndrome Foreign Literature Health Anafranil (Clomipramine Hydrochloride) PS Professional Lithium Carbonate (Lithium Carbonate) SS Manufacturer Route DAILY ORAL ORAL Date:11/25/98ISR Number: 3163297-4Report Type:Expedited (15-DaCompany Report #WAES 98110032 Age:87 YR Gender:Female I/FU:F Outcome Dose PT Duration Report Source Product Role Manufacturer Route Other 500 MG/BID/PO Abdominal Pain Health Dolobid Confusional State Professional Lithium PS ORAL SS 150 Delirium MG/BID/UNK Diarrhoea Lithium SS L-Thyroxine Aspirin Clonazepam C C C 150 Drug Interaction MG/BID/UNK Drug Level Above Therapeutic Mental Disorder Date:11/25/98ISR Number: 3163903-4Report Type:Direct Age:42 YR Gender:Female I/FU:I Outcome Dose Other PT Company Report # Report Source Product Role Lithium PS Duration Lethargy Date:11/27/98ISR Number: 3163872-7Report Type:Expedited (15-DaCompany Report #JAKYO-41140 Age:71 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 83 10:48 AM PT Blood Creatine Decreased Blood Urea Decreased Dizziness Drug Ineffective Electrolyte Imbalance Face Oedema Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ileus Paralytic Liver Disorder Oedema Peripheral Dose Report Source Product Role Manufacturer Route Foreign Risperidone PS Janssen ORAL Lithium Carbonate SS Haloperidol Sulpiride Amitriptyline Hydrochloride Tiapride Hydrochloride Promethazine Hydrochloride Biperiden Hydrochloride Flunitrazepam Spironolactone Vegetamin B Levomepromzine Maleate Alosenn Sennoside Sodium Picosulfate C C Duration 3 MG DAILY Health ORAL Professional ORAL 300 MG DAILY ORAL C C C C C C C C C C C Date:11/30/98ISR Number: 3163987-3Report Type:Expedited (15-DaCompany Report #9838396 Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged 5.00 MG PT Report Source Product Role Clonic Convulsion Health Lithane Tablets PS ORAL Confusional State Professional Aricept SS ORAL Drug Toxicity TOTAL:BID:ORA Tremor L Manufacturer Route Sinemet SS Zestril Tenormin Timoptic Eye Drops Zoloft C C C C ORAL ORAL Date:12/04/98ISR Number: 3174485-5Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Other Company Report #18421-002 PT Report Source Product Role Enamel Anomaly Health Professional Lithium Citrate Syrup PS Manufacturer Route Manufacturer Route Duration Date:12/09/98ISR Number: 3168801-8Report Type:Expedited (15-DaCompany Report #8-98336-037A Age:30 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other 300MG ONCE PT Report Source Product Role Drug Interaction Drug Level Below Therapeutic Foreign Health Professional Trevilor Tablets (Venlafaxine Hydrochloride) PS Libido Decreased DAILY ORAL, 225MG ONCE DAILY, 187.5MG ONCE 22-Aug-2005 Page: 84 14 DAY 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Quilonum Retard (Lithium Carbonate) 450mg Tablets SS ORAL 2.5 TABLETS (1125MG) BEFORE 02NOV98, 3 TABLETS Date:12/09/98ISR Number: 3169169-3Report Type:Expedited (15-DaCompany Report #D/98/04732/LEX Age:28 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 100 MG ORAL 2 YR Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Complications Of Maternal Health Leponex PS Exposure To Therapeutic Drugs Congenital Anomaly Intra-Uterine Death Professional Lithium SS Manufacturer Route ORAL Date:12/09/98ISR Number: 3169350-3Report Type:Expedited (15-DaCompany Report #M090416 Age: Gender:Male I/FU:I Outcome Dose Death 20 MG ORAL PT Report Source Product Role Manufacturer Route Drug Level Above Health Prolixin PS Professional Prolixin Inj SS Ativan SS ORAL Artane SS ORAL Loxitane SS ORAL Duration Therapeutic 10 MG PRN IM INTRAMUSCULAR 2 MG TID ORAL 5 ORAL WK 2 MG TID ORAL 150 MG QD ORAL Restoril SS ORAL Thorazine SS ORAL Lithium SS ORAL 30 MG HS ORAL 50 MG QD ORAL 900 MG OD ORAL Date:12/09/98ISR Number: 3169838-5Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600 MG PO Initial or Prolonged TID Other Company Report # PT Report Source Product Role Agitation Health Lithium Carbonate PS Blood Sodium Abnormal Professional PT Report Source Product Role Manufacturer Route Dysuria Micturition Urgency Consumer Lorazepam Tablets 1mg Mylan PS Mylan ORAL Lithium SS Duration Pollakiuria YR Date:12/10/98ISR Number: 3169135-8Report Type:Expedited (15-DaCompany Report #B042954 Age:68 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 85 ORAL Company Report #98119.01 1MG QID ORAL 15 Route Lethargy Date:12/09/98ISR Number: 3290530-0Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Other Manufacturer 10:48 AM PT Apathy Asthenia FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Coordination Abnormal Drug Interaction Faecal Incontinence Report Source Product Role Haemodialysis Foreign Capoten PS ORAL Nervousness Study Therapeutic Agent Health Lithium Carbonate SS ORAL Toxicity Urinary Incontinence Professional Fluoxetine Hydrochloride SS ORAL Manufacturer Route Duration 100 MG QD ORAL 1 GM QD ORAL 20 MG ORAL Orfidal Nortriptyline Hydrochloride C C Date:12/16/98ISR Number: 3170917-7Report Type:Expedited (15-DaCompany Report #8-98336-037A Age:30 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Other 300 MG ONCE PT Report Source Product Role Manufacturer Drug Interaction Drug Level Below Therapeutic Foreign Health Professional Trevilor (Venlafaxine Hydrochloride) PS ORAL Quilonum Retard (Lithium Carbonate) SS ORAL Quilonum Retard C Route Erectile Dysfunction DAILY ORAL/225 MG ONCE DAILY 14 DAY 2.5 TABLETS (1125 MG)/187.5 MG ONCE DAILY Date:12/16/98ISR Number: 3171998-7Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG X3 Q Initial or Prolonged AM; 300 MG X2 PT Dizziness Company Report # Report Source Product Role Lithium Carbonate PS Drooling Hypernatraemia Q PM Syncope Tremor Urinary Incontinence Date:12/17/98ISR Number: 3170826-3Report Type:Direct Age:67 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 86 10:48 AM PT Amnesia Blood Creatine Phosphokinase Increased Blood Pressure Fluctuation Coma Confusional State Coordination Abnormal Dysarthria Dysphagia Hypotonia Lethargy Mental Disorder Muscle Rigidity Company Report # Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscular Weakness Myocardial Infarction Posturing Dose Report Source Product Role Eskalith PS Haldol SS Manufacturer Route Manufacturer Route Duration Speech Disorder 300 MG AM/ Urinary Incontinence 450 MG PM IM OR PO PRN Date:12/17/98ISR Number: 3171466-2Report Type:Expedited (15-DaCompany Report #9834295 Age:77 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization TABLETS: Initial or Prolonged 50.00 MG PT Report Source Product Role Depression Foreign Zoloft PS ORAL Drug Interaction Health Drug Level Above Professional Lithium SS ORAL Viloxazine Zolpidem Aspegic Glibenclamide C C C C TOTAL:DAILY:O Therapeutic RAL Drug Toxicity 750.00 MG Gamma-Glutamyltransferase TOTAL:DAILY:O Increased RAL Hepatic Enzyme Increased Renal Failure Serotonin Syndrome Date:12/21/98ISR Number: 3172199-9Report Type:Expedited (15-DaCompany Report #8-98344-046A Age: Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization - PT Report Source Product Diarrhoea Headache Foreign Health Trevilor Tablets (Venlafaxine Role Manufacturer Route Initial or Prolonged 75 MG ONCE Joint Swelling Professional Hydrochloride) PS ORAL Hypnorex (Lithium Carbonate) Tablets SS ORAL Imodium (Loperamide) Capsules SS ORAL Zyprexa (Olanzapine) Tablets SS ORAL Zyprexa Hypnorex Ciatyl Imodium C C C C Leukocytoclastic DAILY ORAL Vasculitis Nausea 600 MG DAILY Oedema Peripheral ORAL Purulent Discharge Pyrexia 4 MG GIVEN Rash Erythematous ONLY ONCE Rash Pustular ORAL Toxic Epidermal Necrolysis 20 MG / 15 MG SEE IMAGE ORAL Date:12/22/98ISR Number: 3173495-1Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose PT Company Report # Report Source Product Role Manufacturer Route Cognitive Disorder Lithium PS ORAL Drug Interaction Clozaril SS ORAL Ativan SS ORAL Duration 600 BID ORAL 175 MG DAILY Drug Toxicity PO Leukocytosis 1 MG PO TID Polydipsia 22-Aug-2005 Page: 87 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/24/98ISR Number: 3173353-2Report Type:Direct Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Company Report # Report Source Drug Interaction Drug Toxicity Haemorrhagic Stroke Hypertension Syncope Date:12/24/98ISR Number: 3229447-6Report Type:Periodic Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 5 MG (1 IN 1 Initial or Prolonged D), PER ORAL Product Role Lithium Quinapril Valsartan PS C C Manufacturer Route Manufacturer Route Company Report #A001-002-002817 PT Report Source Product Role Clonic Convulsion Health Aricept (Donepezil) PS Confusional State Professional Lithium (Lithium) Sinemet Zoloft Zestril Tenormin Timoptic SS C C C C C Tremor ORAL Date:12/28/98ISR Number: 3175813-7Report Type:Expedited (15-DaCompany Report #9843242 Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 900.00 MG Initial or Prolonged TOTAL:ORAL PT Report Source Product Role Manufacturer Route Aphasia Literature Lithane PS ORAL Blood Creatinine Health Increased Professional Lisinopril SS ORAL Aspirin SS ORAL 10.00 MG Cerebrovascular Accident TOTAL:ORAL Confusional State 325.00 MG Drug Interaction TOTAL:ORAL Drug Level Above Verapamil SS ORAL 240.00 MG Therapeutic TOTAL:ORAL Dysarthria Haemodialysis Hemiparesis Hypertension Mental Impairment Date:12/30/98ISR Number: 3176937-0Report Type:Expedited (15-DaCompany Report #M090416 Age: Gender:Male I/FU:F Outcome Dose Death 20 MG ORAL PT Report Source Product Role Manufacturer Route Death Health Prolixin PS Professional Prolixin Inj SS Ativan SS ORAL Artane SS ORAL Loxitane SS ORAL Restoril SS ORAL Thorazine SS ORAL Lithium SS ORAL Duration ORAL 10 MG PRN IM 2 MG TID ORAL 5 WK 2 MG TID ORAL 150 MG QD ORAL 30 MG HS ORAL 50 MG QD ORAL 900 MG QD ORAL 22-Aug-2005 Page: 88 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/31/98ISR Number: 3177510-0Report Type:Expedited (15-DaCompany Report #8-98355-088A Age:27 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 250 MG ONE Initial or Prolonged TIME ORAL Other Required Intervention to 220 MG ONE Prevent Permanent TIME ORAL Impairment/Damage PT Report Source Product Role Manufacturer Route Dysarthria Foreign Temesta (Lorazepam) PS ORAL Overdose Health Suicide Attempt Professional Risperdal (Risperidone) Tablets SS ORAL Stablon (Tianeptine) Tablets SS ORAL Teralithe Lp (Lithium) Tablets SS ORAL Stablon Teralithe Lp Risperdal C C C 500 MG ONE TIME ORAL 28 GRAMS ONE TIME ORAL Date:01/05/99ISR Number: 3177596-3Report Type:Expedited (15-DaCompany Report #JAFRA-42291 Age:27 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 220 MG SINGLE Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Drug Toxicity Foreign Risperdal PS Janssen ORAL Dysarthria Health Overdose Professional Tianeptine SS ORAL Lorazepam SS ORAL 500 MG SINGLE ORAL 250 MG SINGLE ORAL FORM:TABLET 2.5 MG Lithium SS ORAL 2800 MG SINGLE ORAL FORM:TABLET 400 MG Date:01/05/99ISR Number: 3178065-7Report Type:Expedited (15-DaCompany Report #9843254 Age:34 YR Gender:Male I/FU:I Outcome Dose Duration Death Life-Threatening PT Report Source Product Role Completed Suicide Literature Health Professional Zoloft Lithium Alprazolam PS SS SS Date:01/06/99ISR Number: 3177991-2Report Type:Direct Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300MG BID & Initial or Prolonged 600MG AT HS PT Difficulty In Walking Drug Toxicity Dysarthria (WAS TAKING Haemodialysis THE WAY AT Sedation HOME, 22-Aug-2005 Page: 89 10:48 AM Manufacturer Route Manufacturer Route Company Report # Report Source Product Role Lithium PS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/99ISR Number: 3179347-5Report Type:Direct Age:65 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG 1T BID Initial or Prolonged PT Company Report # Report Source Asthenia Product Role Lithium Carbonate PS Manufacturer Route Manufacturer Route Blood Potassium Increased Cough Hyponatraemia Oedema Polydipsia Pulmonary Congestion Date:01/11/99ISR Number: 3179532-2Report Type:Expedited (15-DaCompany Report #LBID002990002 Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600 MG, PER Initial or Prolonged DAY, PER ORAL PT Report Source Product Role Agitation Consumer Lithobid PS ORAL Therapeutic Zyprexa SS ORAL Feeling Drunk Benzotropine SS ORAL Nausea Tremor Wellbutrin Neurontin SS SS ORAL Klonopin SS ORAL Ambien SS ORAL Zoloft SS ORAL Lithobid SS ORAL Drug Level Above PER ORAL PER ORAL PER ORAL PER ORAL PER ORAL PER ORAL 600 MG, PER DAY, PER ORAL Date:01/13/99ISR Number: 3180149-4Report Type:Direct Age:73 YR Gender:Male I/FU:I Company Report # Outcome Dose Duration Required 600MG Q AM; Intervention to 900MG Q PM Prevent Permanent 600MG PO TID Impairment/Damage PT Report Source Confusional State Product Role Lithium PS Ibuprofen SS Manufacturer Route Faeces Discoloured Lethargy ORAL Sedation Therapeutic Agent Toxicity Date:01/13/99ISR Number: 3180319-5Report Type:Expedited (15-DaCompany Report #LBID002980038 Age:70 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 600 MG, PER Initial or Prolonged DAY, PER ORAL PT Report Source Product Role Cerebrovascular Accident Health Lithobid PS Confusional State Professional Haldol C Dialysis Drug Level Above Therapeutic Lethargy Memory Impairment Date:01/13/99ISR Number: 3183647-2Report Type:Expedited (15-DaCompany Report #1998014020-1 Age:55 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 90 10:48 AM PT Coma Depressed Level Of Consciousness Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Drug Interaction Drug Level Above Therapeutic Report Source Product Role Mental Impairment Health Lithium PS Pneumonia Aspiration Professional Hydrochlorothiazide Risperdal C C Manufacturer Route Manufacturer Route Duration 300 MG , 3.0 DAILY 10 DAY Pyrexia Subdural Haematoma Date:01/19/99ISR Number: 3182106-0Report Type:Expedited (15-DaCompany Report #8-99011-044A Age:39 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1.5 G ONE Initial or Prolonged TIME ORAL Other 5.6 G ONE PT Report Source Product Role Coordination Abnormal Foreign Efexor PS ORAL Drug Level Above Health Therapeutic Professional Lithium SS ORAL Thioridazine SS ORAL Zopiclone SS ORAL Overdose TIME ORAL Sedation 750 MG ONE Tremor TIME ORAL 45 MG ONE TIME ORAL Date:01/19/99ISR Number: 3182794-9Report Type:Expedited (15-DaCompany Report #9806748 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Medication Error Health Lithane PS Serotonin Syndrome Professional Trilafon Klonopin Trazodone C C C Manufacturer Route ORAL Nardil C Date:01/21/99ISR Number: 3183993-2Report Type:Expedited (15-DaCompany Report #9821939 Age: Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 25.00 MG Hospitalization TOTAL:DAILY:O Initial or Prolonged RAL Required 75.00 MG Intervention to TOTAL:DAILY:O Prevent Permanent RAL Impairment/Damage 900.00 MG PT Report Source Product Role Manufacturer Route Abdominal Pain Health Zoloft PS ORAL Blood Amylase Increased Professional Wellbutrin SS ORAL Lithane SS Motrin C Drug Ineffective Gastrooesophageal Reflux Disease Obstruction Pancreatitis Acute TOTAL:DAILY Date:01/21/99ISR Number: 3184170-1Report Type:Expedited (15-DaCompany Report #99F--10026 Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization DAILY ORAL Initial or Prolonged PT Report Source Product Role Drug Level Above Foreign Tegretol PS Therapeutic Encephalopathy Health Professional Teralithe Leponex SS SS Other Depamide Barnetil SS SS Deroxat SS Manufacturer Route ORAL ORAL ORAL 22-Aug-2005 Page: 91 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/25/99ISR Number: 3185404-XReport Type:Expedited (15-DaCompany Report #9901138 Age: Gender:Unknown I/FU:I Outcome Dose Duration Required ORAL Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Thyroiditis Chronic Foreign Lithane Tablets PS Manufacturer Route ORAL Literature Health Professional Date:01/25/99ISR Number: 3185410-5Report Type:Expedited (15-DaCompany Report #9901139 Age: Gender:Unknown I/FU:I Outcome Dose Duration Required ORAL Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Thyroiditis Chronic Foreign Lithane Tablets PS Manufacturer Route ORAL Literature Health Professional Date:01/25/99ISR Number: 3185413-0Report Type:Expedited (15-DaCompany Report #9901140 Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Required ORAL Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Hyperthyroidism Foreign Lithane Tablets PS Manufacturer Route ORAL Literature Health Professional Date:01/25/99ISR Number: 3185419-1Report Type:Expedited (15-DaCompany Report #9901141 Age:59 YR Gender:Male I/FU:I Outcome Dose Duration Required ORAL Intervention to PT Report Source Product Role Hyperthyroidism Foreign Lithane Tablets PS Literature Manufacturer Route ORAL Prevent Permanent Impairment/Damage Health Professional Date:01/25/99ISR Number: 3185423-3Report Type:Expedited (15-DaCompany Report #9901142 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Goitre Foreign Lithane Tablets PS Manufacturer Route ORAL Literature Health Professional Date:01/25/99ISR Number: 3185425-7Report Type:Expedited (15-DaCompany Report #9901143 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 92 10:48 AM PT Report Source Product Role Goitre Foreign Lithane Tablets PS Literature Health Professional Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/25/99ISR Number: 3185637-2Report Type:Expedited (15-DaCompany Report #F/99/00037/LEX Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged ORAL Required Intervention to Prevent Permanent ORAL Impairment/Damage 40 MG ORAL PT Report Source Product Role Manufacturer Route Drug Level Above Leponex PS ORAL Therapeutic Tegretol SS ORAL Encephalopathy Depamide Barnetil Teralithe SS SS SS ORAL Deroxat SS ORAL Date:01/27/99ISR Number: 3186879-2Report Type:Expedited (15-DaCompany Report #1999001675-1 Age:31 YR Gender:Male I/FU:I Outcome Dose Duration Required ORAL Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dysarthria Health Lithium PS Smithkline Beecham ORAL Dysgraphia Movement Disorder Muscle Rigidity Proctalgia Tremor Professional Synthroid Atenolol Clozaril C C C Manufacturer Route Date:01/27/99ISR Number: 3187837-4Report Type:Expedited (15-DaCompany Report #199910106RHF Age:74 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Cholecystitis Acute Foreign Glibenclamide (Daonil 5 Mg) Tablets PS ORAL Simvastatin (Zocor) Tablets SS ORAL PO 20 MG QD PO Venlafaxine Hydrochloride SS Triptorelin Acetate (Decapeptyl-Slow Release) Solution To Injection SS Lithium Bromide (Lithium Microsol) SS ORAL 2 U/DAY PO INTRAMUSCULAR 1 U/DAY IM ORAL 4 U/DAY PO Buflomedil Hydrochloride Acetylsalicylate Lysine Diltiazem Hydrochloride C C C Date:01/29/99ISR Number: 3188458-XReport Type:Expedited (15-DaCompany Report #LBID002980038 Age:70 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 600 MG PER Initial or Prolonged ORAL PT Report Source Product Role Cerebrovascular Accident Health Lithobid PS Confusional State Professional Depakote Haldol C C Dialysis Drug Level Above Therapeutic Lethargy Memory Impairment 22-Aug-2005 Page: 93 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/99ISR Number: 3189672-XReport Type:Expedited (15-DaCompany Report #9902754 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 1200.00 MG Initial or Prolonged TOTAL DAILY PT Report Source Product Role Bipolar Disorder Foreign Lithane PS Hydrocephalus Health Tremor Professional Methotrimeprazine C Manufacturer Route ORAL ORAL Date:02/01/99ISR Number: 3190235-0Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization ? Initial or Prolonged PT Company Report # Report Source Mental Impairment Date:02/01/99ISR Number: 3404643-3Report Type:Periodic Age:35 YR Gender:Male I/FU:I Outcome Dose Product Role Lithium PS Manufacturer Route Manufacturer Route Company Report #A0074390 PT Report Source Product Role Drug Interaction Health Wellbutrin Tablet PS Primary Cerebellar Professional Lithium Salt (Formulation Unknown) SS Duration 150 MG/ THREE TIMES PER DAY Degeneration ORAL Tremor Date:02/01/99ISR Number: 3410864-6Report Type:Periodic Age: Gender:Male I/FU:I Company Report #A0068255 ORAL Outcome Dose PT Report Source Product Role Insomnia Consumer Health Professional Wellbutrin (Formulation Unknown) PS Other Lithium Salt (Formulation Unknown) Nicotine (Formulation Unknown) Manufacturer Route Duration ORAL ORAL Date:02/02/99ISR Number: 3190266-0Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 2 Q AM + 3 Initial or Prolonged QHS 20 YR Required Intervention to 1 BID WM + 1 Prevent Permanent QID X 5D Impairment/Damage 1 QID X5D 22-Aug-2005 Page: 94 10:48 AM SS SS Company Report # PT Report Source Product Role Drug Interaction Health Lithium Carb PS Drug Toxicity Professional Ibuprofen, 800 Mg Tab + Advil 200 Mg SS Mesoridazine Methocarbamol Multivitamin Advil C C C C Insomnia Nausea Polydipsia Polyuria Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3190449-XReport Type:Direct Age:57 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1500MG BID Initial or Prolonged 1200MG Q HS PT Company Report # Report Source Product Role Atrial Fibrillation Depakote PS Bowel Sounds Abnormal Lithium Carbonate SS Drug Level Above Therapeutic Mental Impairment Sedation Vomiting Testostone Asa Famotidine C C C Date:02/02/99ISR Number: 3190455-5Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Death 1T PO AM 3 PO Life-Threatening HS Hospitalization Initial or Prolonged 1T PO BID PC Other T PO QD Required Intervention to Prevent Permanent Impairment/Damage PT Manufacturer Route Manufacturer Route Company Report # Report Source Drug Toxicity Product Role Lithium PS ORAL Diclofenac & Misoprostol SS ORAL Lisinopril SS ORAL Date:02/04/99ISR Number: 3192283-3Report Type:Expedited (15-DaCompany Report #JAGER-42776 Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening -, SINGLE Hospitalization ORAL PT Report Source Product Role Manufacturer Route Blister Foreign Imodium (Loperamide) PS Janssen ORAL Diarrhoea Health Initial or Prolonged Leukocytoclastic Vasculitis Professional Trevilor (Venlafaxine) SS ORAL Zyprexa (Olanzapine) SS ORAL Hypnorex (Lithium Carbonate) SS ORAL Ciatyl Praxiten C C 75 MG; Nausea DAILY; ORAL 30 DAY Oedema Peripheral 20MG DAILY; Pain 15MG DAILY; Pyrexia 10MG DAILY; Toxic Epidermal ORAL; TABLET 38 DAY Necrolysis 600 MG DAILY; ORAL; TABLET 400MG 17 DAY Date:02/04/99ISR Number: 3298814-7Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Company Report #M085770 PT Report Source Product Role Malaise Health Serzone Tabs PS Professional Lithium SS ORAL 22-Aug-2005 Page: 95 Manufacturer Route Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/99ISR Number: 3298869-XReport Type:Periodic Age: Gender: I/FU:I Outcome Dose Company Report #M090676 PT Report Source Product Role Weight Increased Health Serzone Tabs PS Lithium SS Manufacturer Route Duration ORAL 300 MG QD Professional ORAL Date:02/04/99ISR Number: 3300574-8Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Company Report #M075513 PT Report Source Product Role Coordination Abnormal Health Serzone Tabs 250 Mg PS Drug Interaction Professional Lithium SS Manufacturer Route Duration ORAL 250 MG BID ORAL Drug Level Below Therapeutic Mania Speech Disorder Thinking Abnormal Date:02/04/99ISR Number: 3303832-6Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Company Report #M085927 PT Report Source Product Role Agitation Health Serzone Tabs PS Drug Interaction Insomnia Professional Lithium Augmentin Ssri Wellbutrin Effexor Remeron SS C C C C C Manufacturer Route Duration ORAL ORAL Date:02/05/99ISR Number: 3198954-7Report Type:Periodic Age:36 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report #FLUV002980256 PT Report Source Product Role Manufacturer Route Depression Hypertonia Leukocytosis Health Professional Luvox Tablets (Fluvoxamine Maleate) PS ORAL Lithium Carbonate Capsules (Lithium Carbonate) SS ORAL Risperdal (Risperidone) SS ORAL Thorazine (Chlorpromazine Hydrochloride) SS ORAL Effexor C PER ORAL Neuroleptic Malignant Syndrome Pyrexia 300 MG , PER Urinary Incontinence ORAL 4.5 MG , PER ORAL PER ORAL Date:02/05/99ISR Number: 3199672-1Report Type:Periodic Age:53 YR Gender:Male I/FU:I Outcome Dose Other 300 MG, PER Company Report #FLUV002980218 PT Report Source Product Role Manufacturer Route Confusional State Consumer Luvox PS ORAL Lithium SS ORAL Duration Speech Disorder ORAL Tongue Oedema 1200 MG, PER 22-Aug-2005 Page: 96 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Clozaril Valium Date:02/05/99ISR Number: 4515995-5Report Type:Direct Age: Gender: I/FU:I Outcome Dose PT C C Company Report #USP 52040 Report Source Product Role Lithium Carbonate PS Lithium Carbonate SS Manufacturer Route Manufacturer Route Duration Medication Error CAPSULE TABLET Date:02/08/99ISR Number: 3193819-9Report Type:Direct Age:43 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 900MG PO BID Initial or Prolonged PT Company Report # Product Role Aphonia Lithium PS Blood Creatinine Increased Blood Urea Increased Clonic Convulsion Coma Convulsion Depressed Level Of Consciousness Drug Level Above Therapeutic Haemodialysis Hyperreflexia Hypokalaemia Tremor Vomiting Seventili Hctz Diltiazem Cd Diphenhydiamine C C C C Date:02/09/99ISR Number: 3193737-6Report Type:Direct Age:65 YR Gender:Female I/FU:I Report Source Company Report # ORAL Outcome Dose Duration Hospitalization 300MG PO BID Initial or Prolonged PT Confusional State 22-Aug-2005 Page: 97 10:48 AM Product Role Lithium PS Manufacturer Route Manufacturer Route Difficulty In Walking Drug Toxicity Date:02/09/99ISR Number: 3194991-7Report Type:Direct Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Report Source Company Report # PT Report Source Product Role Blood Creatinine Increased Blood Potassium Increased Blood Sodium Increased Confusional State Dialysis Drug Toxicity Gait Disturbance Lethargy Pco2 Decreased Health Professional Lithium Tegretal Haldol Congentin PS C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/12/99ISR Number: 3198186-2Report Type:Expedited (15-DaCompany Report #1998-09-0774 Age:33 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Cold Sweat Dissociative Disorder Dizziness Dysphemia Health Professional Other Prometrium (Micronized Oral Progesterone) Capsules PS ORAL Lithium Citrate SS ORAL Duration 80 MG DAILY Flushing ORAL Hyperhidrosis 300 MG BID Lethargy ORAL Malaise Panic Attack Speech Disorder Syncope Date:02/12/99ISR Number: 3406117-2Report Type:Periodic Age:8 YR Gender:Male I/FU:I Outcome Dose Company Report #97USA12189 PT Report Source Product Role Manufacturer Route Aggression Food Intolerance Consumer Tegretol Chewable Tablet (Carbamazepine) PS ORAL Lithium Citrate Syrup (Lithium Citrate) SS ORAL Duration DAILY, ORAL 300 MG, DAILY, ORAL Date:02/16/99ISR Number: 3199128-6Report Type:Expedited (15-DaCompany Report #9903672 Age:66 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization 900.00 MG Initial or Prolonged TOTAL:TID:ORA Agitation Foreign Drug Toxicity Health Nervous System Disorder Professional Lithane Tablets PS Pramipexole Venlafaxine C C ORAL L Date:02/16/99ISR Number: 3199705-2Report Type:Expedited (15-DaCompany Report #9904507 Age: Gender:Male I/FU:I Outcome Dose Duration Required 900.00 MG Intervention to TOTAL:TID:ORA Prevent Permanent L Impairment/Damage PT Report Source Product Role Heart Rate Increased Consumer Lithane PS Lithium SS Manufacturer Route ORAL Date:02/17/99ISR Number: 3200770-4Report Type:Expedited (15-DaCompany Report #1999003648-1 Age:60 YR Gender:Female I/FU:I Outcome Dose Other 22-Aug-2005 Page: 98 PT Report Source Product Role Diabetes Insipidus Nephrectomy Renal Failure Consumer Lithium Thorazine PS SS Duration 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/99ISR Number: 3203018-XReport Type:Expedited (15-DaCompany Report #1998-09-0774 Age: Gender:Female I/FU:F Outcome Dose Other 800MG DAILY PT Report Source Product Role Manufacturer Route Cold Sweat Health Prometrium PS ORAL Depersonalisation Professional Dissociation Other Lithium Citrate SS ORAL Prozac Capsules SS ORAL Duration ORAL 300 MG BID Dizziness ORAL Drug Interaction 60 MG QD ORAL Drug Level Above Therapeutic Flushing Hyperhidrosis Lethargy Malaise Panic Attack Speech Disorder Syncope Date:02/24/99ISR Number: 3204839-XReport Type:Direct Age:41 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report # PT Report Source Product Role Dysarthria Mental Impairment Polydipsia Polyuria Tremor Vomiting Health Professional Lithium Carbonate Divalproex Sodium PS SS Date:02/24/99ISR Number: 3204859-5Report Type:Direct Age:45 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization - Manufacturer Route Manufacturer Route Company Report # PT Report Source Product Role Drug Level Above Health Lithium PS Initial or Prolonged Therapeutic Dysarthria Medication Error Parkinsonian Gait Thirst Professional Carbamazepine SS Date:02/24/99ISR Number: 3206755-6Report Type:Expedited (15-DaCompany Report #9834295 Age:77 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization TABLETS, Initial or Prolonged 50.00 MG PT Report Source Product Role Manufacturer Route Confusional State Foreign Zoloft PS ORAL Disorientation Health Gamma-Glutamyltransferase Professional Lithium SS ORAL Viloxazine Zolpidem Aspegic Glibenclamide C C C C TOTAL:DAILY:O Increased RAL Hepatic Enzyme Increased 750.00 Loss Of Consciousness TOTAL:DAILY:O Renal Failure RAL Serotonin Syndrome Therapeutic Agent Toxicity Tremor 22-Aug-2005 Page: 99 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3208689-XReport Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Other 200.00 MG Company Report #9838140 PT Report Source Product Role Manufacturer Route Arthralgia Health Zoloft Tablets PS ORAL Drug Interaction Professional Lithium SS ORAL Duration TOTAL: DAILY: ORAL 1200.00 MG TOTAL: DAILY: ORAL Date:02/25/99ISR Number: 3208778-XReport Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other ORAL Company Report #9836238 PT Report Source Product Muscle Spasms Health Zoloft Muscle Twitching Professional Company Representative Lithane Role Manufacturer Route Duration Date:02/25/99ISR Number: 3209007-3Report Type:Periodic Age:22 YR Gender:Female I/FU:F Outcome Dose Duration Other TABLET, ORAL Tablets PS ORAL SS Company Report #9721690 PT Report Source Product Role Manufacturer Route Anorexia Consumer Zoloft Tablets PS ORAL Depression Health Antibiotic SS ORAL Hostility Professional Redux SS ORAL Lithium SS ORAL ORAL ORAL Increased Appetite 1200.00 MG Neurosis TOTAL:BID:ORA Weight Increased L Ritalin Tegretol Klonopin Date:02/25/99ISR Number: 3210105-9Report Type:Periodic Age:62 YR Gender:Male I/FU:I Outcome Dose Other 150.00 MG C C C Company Report #9819344 PT Report Source Product Role Manufacturer Route Erectile Dysfunction Health Zoloft Tablets PS ORAL Lithonate SS ORAL Prilosec Trinalin Hydroxyzine Synthroid C C C C Duration Professional TOTAL: DAILY: ORAL 300.00 MG TOTAL: DAILY: ORAL Date:02/25/99ISR Number: 3210112-6Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other 22-Aug-2005 Page: 100 Company Report #9818616 PT Report Source Product Role Tremor Consumer Zoloft Tablets Lithium PS SS Duration 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3211927-0Report Type:Periodic Age:45 YR Gender:Female I/FU:I Outcome Dose Other 50.00 MG Company Report #9804452 PT Report Source Product Role Manufacturer Route Arthralgia Health Zoloft Tablets PS ORAL Hypertonia Professional Lithium Carbonate SS ORAL Duration TOTAL:DAILY:O Osteoarthritis RAL 1200.00 MG TOTAL:DAILY:O RAL Date:02/25/99ISR Number: 3212168-3Report Type:Periodic Age:41 YR Gender:Female I/FU:I Outcome Dose Other Company Report #JAUSA-35342 PT Report Source Product Role Manufacturer Route Dizziness Dyspnoea Weight Increased Consumer Risperdal (Risperidone), Janssen, Tablet 4 Mg PS ORAL Lithium Tablet SS ORAL Duration 4 MG, 3 DAILY, ORAL ORAL Date:02/25/99ISR Number: 3213544-5Report Type:Periodic Age:34 YR Gender:Female I/FU:I Outcome Dose Other Company Report #JAUSA-35255 PT Report Source Product Role Manufacturer Route Thirst Weight Increased Health Professional Risperdal (Risperidone) PS Janssen ORAL Duration 2 MG 2 DAILY ORAL Eskalith (Lithium) Tablet SS ORAL Paxil (Paroxetine) SS ORAL 450 MG 3 DAILY ORAL 20 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3217325-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other DAILY: ORAL Company Report #9811456 PT Report Source Product Role Drug Interaction Health Zoloft Tablets PS ORAL Drug Tolerance Decreased Professional Lithane SS ORAL Manufacturer Route Duration ORAL Dysgeusia Dyspepsia Influenza Like Illness Date:02/26/99ISR Number: 3208903-0Report Type:Direct Age:65 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG DAILY Initial or Prolonged ORAL Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 101 10:48 AM PT Gait Disturbance Company Report # Report Source Product Role Lithium PS Aspirin Clonazepam Buprion (Wellbutrin) Risperidone Furosemide Lisinopril C C C C C C Lethargy Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/99ISR Number: 3208985-6Report Type:Direct Age:41 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 450MG ,AT Initial or Prolonged BEDTIME, ORAL PT Company Report # Report Source Disorientation Role Lithium PS Oxazepam Insulin Human 70/30 Cisapride Divalproex Bupropion (Wellbutrin) Risperidone Diphenhydramine Furosemide C C C C Manufacturer Route Manufacturer Route Lethargy Date:02/26/99ISR Number: 3217017-5Report Type:Periodic Age:34 YR Gender:Female I/FU:I Outcome Dose Other ORAL Product C C C C Company Report #8-98345-071A PT Report Source Product Role Thirst Health Effexor PS ORAL Weight Increased Professional Eskalith (Lithium) Tablets SS ORAL Paxil (Paroxetine) SS ORAL Risperdal (Risperidone) Tablets SS ORAL Duration 450 MG THREE TIMES DAILY ORAL 20 MG TWICE DAILY ORAL 2 MG TWICE DAILY ORAL Date:02/26/99ISR Number: 3416480-4Report Type:Periodic Age:37 YR Gender:Male I/FU:I Outcome Dose Company Report #1998011626-1 PT Report Source Product Role Manufacturer Route Drug Interaction Pollakiuria Health Professional Relafen Smithkline Beecham PS Smithkline Beecham ORAL Eskalith Cr (Lithium) SS Duration 1000 Tremor MILLIGRAMS 1.0 DAILY ORAL 6 DAY ORAL 2.0 DAILY ORAL Date:03/01/99ISR Number: 3208245-3Report Type:Direct Age: Gender: I/FU:I Outcome Dose PT Company Report # Report Source Product Role Lithium Carbonate PS Lithium Carbonate SS Duration Medication Error CAPSULE TABLET Date:03/01/99ISR Number: 3209574-XReport Type:Expedited (15-DaCompany Report #990222-008010775 Age:52 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 102 10:48 AM PT Condition Aggravated Idiopathic Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Thrombocytopenic Purpura Increased Tendency To Bruise Medication Error Report Source Product Role Platelet Count Decreased Health Haloperidol PS ORAL Psychotic Disorder Professional Lithium SS ORAL Depakote SS ORAL Risperidone C ORAL Manufacturer Route Duration 5 MG, QD, ORAL Red Blood Cell Count 300 MG, TID, Decreased ORAL White Blood Cell Count 1250 MG, QD, Increased ORAL 1MG, BID, ORAL Date:03/01/99ISR Number: 3210683-XReport Type:Direct Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged PT Company Report # Report Source Headache Hypertension Lethargy Movement Disorder Vomiting Date:03/01/99ISR Number: 3217977-2Report Type:Periodic Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization 10 MG/ML Q2H Initial or Prolonged NASAL SP 5 YR Disability 1 MG TID Product Role Citalopram Lithium Dexatrim (Phenylpropanolamine ) PS SS Route Manufacturer Route C Company Report #M072945 PT Report Source Product Role Amnesia Other Stadol Nasal Spray PS Xanax SS Drug Dependence Drug Withdrawal Syndrome Manufacturer NASAL Skin Disorder Prozac SS Lithobid SS 20 MG BID 300 MG BID Date:03/01/99ISR Number: 3439088-3Report Type:Periodic Age:30 YR Gender:Male I/FU:I Outcome Dose Company Report #1998021859-1 PT Report Source Product Role Manufacturer Route Apathy Lethargy Consumer Paxil Smithkline Beecham PS Smithkline Beecham ORAL Eskalith (Lithium) Smithkline Beecham SS Smithkline Beecham ORAL SS Smithkline Beecham SS Smithkline Beecham SS Smithkline Beecham SS Smithkline Beecham SS Smithkline Beecham SS Smithkline Beecham Duration 40 MILLIGRAMS Suicidal Ideation ORAL 1350 MILLIGRAMS ORAL Paxil Smithkline Beecham Paxil Smithkline Beecham Paxil Smithkline Beecham ORAL 20 MILLIGRAMS 1.0 DAILY ORAL Paxil Smithkline Beecham Paxil Smithkline Beecham Eskalith (Lithium) Smithkline Beecham 900 MILLIGRAMS 22-Aug-2005 Page: 103 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Klonopin Hs (Clonazepam) St Johns' Wart C St Johns' Wart Manufacturer Date:03/03/99ISR Number: 3211736-2Report Type:Expedited (15-DaCompany Report #9906597 Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged 600.00 MG PT Report Source Product Role Agitation Health Zoloft Tablets PS ORAL Drug Level Above Professional Lithobid SS ORAL Nausea Zyprexa SS ORAL Tremor Benztropine SS ORAL Wellbutrin Neurontin Klonopin Ambien C C C C Route Therapeutic TOTAL: DAILY: Feeling Drunk ORAL ORAL ORAL Date:03/05/99ISR Number: 3214470-8Report Type:Expedited (15-DaCompany Report #A0082673 Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Manufacturer Route Agitation Health Wellbutrin Tablet PS ORAL Drug Level Above Therapeutic Professional Other Lithium Carbonate Tablet SS ORAL Feeling Drunk Olanzapine Tablet SS ORAL Nausea Benzatropine Tablet SS ORAL Tremor Gabapentin Tablet SS ORAL ORAL ORAL ORAL ORAL Clonazepam Tablet SS ORAL Zolpidem Tartrate Tablet SS ORAL Sertraline Hydrochloride Tablet SS ORAL ORAL ORAL ORAL Date:03/08/99ISR Number: 3214965-7Report Type:Expedited (15-DaCompany Report #JAUSA-36247 Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Condition Aggravated Idiopathic Thrombocytopenic Purpura Health Professional Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL Haldol (Haloperidol), Janssen, Tablet SS Janssen ORAL Lithium (Lithium) SS ORAL Depakote (Valproate Sodium) SS ORAL Nifedipine Klonopin C C 1 MG 2 DAILY Increased Tendency To ORAL 2 MG 2 Bruise DAILY Medication Error Platelet Count Decreased Psychotic Disorder 5 MG 1 DAILY Red Blood Cell Count ORAL Decreased 300 MG 3 White Blood Cell Count DAILY ORAL 8 DAY Increased 1250 MG DAILY ORAL 500 MG AT 8 AM AND 8 PM, 250 MG AT 12 N 22-Aug-2005 Page: 104 8 DAY 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prednisone Date:03/08/99ISR Number: 3216169-0Report Type:Direct Age:69 YR Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report # PT Report Source Product Role Haemodialysis Therapeutic Agent Toxicity Health Professional Lithium PS Date:03/08/99ISR Number: 3216240-3Report Type:Direct Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG, BID, Initial or Prolonged PO Required Intervention to Prevent Permanent Impairment/Damage Report Source Product Role Asthenia Health Lithium PS Coma Professional Theophiline Depakote Albuterol C C C Dialysis Difficulty In Walking Eating Disorder Eye Discharge Hypernatraemia Hypovolaemia Insomnia Rash Erythematous Renal Failure Acute Sepsis Therapeutic Agent Toxicity PT Asthenia Blood Pressure Decreased Confusional State Manufacturer Route Manufacturer Route Company Report # PT Date:03/10/99ISR Number: 3218232-7Report Type:Direct Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged C ORAL Company Report # Report Source Product Role Lithium Gluburide Metoprolol PS C C Manufacturer Route Depressed Level Of Consciousness Diarrhoea Drug Toxicity Hallucination Heart Rate Decreased Irritability Lethargy Muscle Rigidity Tremor Date:03/10/99ISR Number: 3218592-7Report Type:Direct Age:42 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 105 10:48 AM PT Asthenia Depressed Level Of Consciousness Diarrhoea Drug Level Above Therapeutic Clonidine Benadryl Company Report # C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Toxicity Hallucination Irritability Dose Report Source Product Role Lithium PS Manufacturer Route Manufacturer Route Manufacturer Route Duration Lethargy DOSE WAS Medication Error SUPPOSED TO Muscle Rigidity BE 1 1/2 TAB Tremor AM, 1/2 TAB NOON, 1 1/2 Date:03/16/99ISR Number: 3220487-XReport Type:Direct Age:36 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report # PT Report Source Product Role Drug Level Above Therapeutic Heart Rate Abnormal Health Professional Lithium Haldol Cogentin Benadryl Vitamins PS C C C C Date:03/19/99ISR Number: 3223450-8Report Type:Expedited (15-DaCompany Report #99USA10110 Age:68 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 80 MG, DAILY, PT Report Source Product Role Accidental Overdose Atrioventricular Block Health Professional Diovan Capsule (Valsartan) PS ORAL First Degree Other Lithium Unnknown 300 Mg (Lithium Carbonate) SS ORAL ORAL Blood Creatinine Increased Blood Urea Increased 600MG, DAILY, Cerebrovascular Accident ORAL Drug Interaction Quinapril Tablet Drug Toxicity (Quinapril) SS Electrocardiogram Abnormal Hypertension Hypotension Sinus Bradycardia Syncope Warfarin Tablet C ORAL ORAL Date:03/19/99ISR Number: 3223732-XReport Type:Expedited (15-DaCompany Report #1999001675-1 Age:31 YR Gender:Male I/FU:F Outcome Dose Duration Required ORAL Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dysarthria Consumer Lithium PS Smithkline Beecham ORAL Movement Disorder Muscle Rigidity Musculoskeletal Stiffness Proctalgia Tremor Health Professional Synthroid Atenolol Clozaril C C C Date:03/22/99ISR Number: 3224105-6Report Type:Expedited (15-DaCompany Report #9910443 Age:16 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Required 22-Aug-2005 Page: 106 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage Dose PT Report Source Product Role Anorexia Health Zoloft Tablets PS Bipolar Disorder Professional Lithium Depakote Remeron Tylenol Advil Unspecified Prescription Medication SS SS SS C C Manufacturer Route Duration ORAL 200.00 MG TOTAL:DAILY:O Drug Interaction RAL Hallucination Heart Rate Increased Intentional Misuse Respiratory Rate Increased Date:03/24/99ISR Number: 3224433-4Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 10MG QD PO PT Company Report # Product Role Drug Toxicity Lisinopril 10mg Qd PS Hyperkalaemia Lithium ( ) SS Date:03/24/99ISR Number: 3224446-2Report Type:Direct Age:70 YR Gender:Male I/FU:I Outcome Dose Duration Required 300MG Q AM Intervention to 2PM LONG-TERM Prevent Permanent Impairment/Damage +450MG QHS C PT Report Source Route ORAL Company Report # Product Role Lithium PS Confusional State Drooling Risperidone 0.5mg Bid SS Exophthalmos Benztropine Dipherhydramine Lorazepam C C C Body Temperature Manufacturer Report Source Decreased Manufacturer Route Risperidone Date:03/25/99ISR Number: 3225616-XReport Type:Direct Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Company Report # PT Report Source Product Role Drug Toxicity Health Professional Lithium PS Date:03/31/99ISR Number: 3418709-5Report Type:Periodic Age:39 YR Gender:Male I/FU:I Outcome Dose C Manufacturer Route Manufacturer Route Company Report #981125-107058367 PT Report Source Product Role Asthenia Catatonia Erectile Dysfunction Consumer Haldol Decanoate, Unspecified (Haloperidol) PS Lithium SS Duration IM Hypertonia (INTRAMUSCULA Malaise R) Speech Disorder ORAL Urinary Incontinence 22-Aug-2005 Page: 107 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/99ISR Number: 3231240-5Report Type:Expedited (15-DaCompany Report #1999007024-1 Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200 MG Initial or Prolonged Other PT Report Source Product Role Blood Creatinine Literature Lithium Carbonate PS Increased Coma Hypernatraemia Hyperosmolar State Nephrogenic Diabetes Insipidus Pollakiuria Polydipsia Polyuria Sedation Thirst Health Professional Haloperidol Lorazepam C C Manufacturer Route Manufacturer Route Manufacturer Route Date:04/01/99ISR Number: 3231243-0Report Type:Expedited (15-DaCompany Report #1999007096-1 Age:52 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Blood Creatinine Increased Blood Sodium Increased Blood Urea Increased Dehydration Hypomania Mania Nephrogenic Diabetes Insipidus Pollakiuria Renal Failure Chronic Thirst Health Professional Lithium Carbonate PS Date:04/01/99ISR Number: 3231962-6Report Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose PT Duration Company Report #7397661 Report Source Product Role Other 500.000 MG PO Alopecia Health Condition Aggravated Professional Thyroid Disorder Other Abbott-Depakote PS Lithium SS Zyprexa C Abbott ORAL TID 300.000 MG QD Weight Increased Date:04/06/99ISR Number: 3236474-1Report Type:Periodic Age:41 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 450MG 2 Company Report #1998000342-1 PT Report Source Product Role Manufacturer Route Blood Creatinine Increased Health Professional Eskalith Smithkline Beecham PS Smithline Beecham ORAL Fluphenazine Carbamazepine Ativan C C C Blood Pressure Increased DAILY; 150MG Condition Aggravated 2 DAILY 19 DAY Hypothyroidism Therapeutic Agent Toxicity Tremor 22-Aug-2005 Page: 108 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/99ISR Number: 3236477-7Report Type:Periodic Age:67 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1.0 DAILY Company Report #1998022961-1 PT Report Source Product Role Manufacturer Route Confusional State Health Professional Eskalith Smithkline Beecham PS Smithkline Beeecham ORAL Manufacturer Route Route ORAL Date:04/06/99ISR Number: 3237294-4Report Type:Periodic Age:39 YR Gender:Female I/FU:I Outcome Dose Other 310 Company Report #1998027577-1 PT Report Source Product Role Acne Benign Intracranial Health Professional Lithium Smithkline Beecham PS Duration DAY Hypertension Blood Thyroid Stimulating Hormone Increased Fatigue Date:04/06/99ISR Number: 3237295-6Report Type:Periodic Age:81 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 Company Report #1998011628-1 PT Report Source Product Role Manufacturer Dehydration Therapeutic Agent Health Professional Eskalith Smithkline Beecham PS Smithkline Beecham Trilafon Ativan Zoloft C C C Toxicity MILLIGRAMS 3.0 DAILY Date:04/06/99ISR Number: 3237296-8Report Type:Periodic Age:58 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening ORAL 8 Company Report #1998007471-1 PT Report Source Product Role Manufacturer Route Coronary Artery Disease Heart Rate Decreased Health Professional Eskalith Smithkline Beecham PS Smithkline Beecham ORAL Lithobid C YR Date:04/06/99ISR Number: 3237297-XReport Type:Periodic Age:58 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 Company Report #1998005301-1 PT Report Source Product Role Manufacturer Route Drug Toxicity Health Professional Lithium Smithkline Beecham PS Smithkline Beecham ORAL Guaifenesin / Dextromethorpham Tobramycin Accupril Zocor Toprol Minipres Cephalexin C C C C C C C MILLIGRAMS 4.0 DAILY ORAL 22-Aug-2005 Page: 109 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/99ISR Number: 3234309-4Report Type:Direct Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization T1C PO T Initial or Prolonged PT Product Role Confusional State Lithium Carbonate PS Coordination Abnormal Drug Toxicity Feeling Jittery Famotidine Thiamine Hcl Thiamine Hcl Albuterol Vitamin B Complex/Vitamin C Albuterol Ipratropium Bromide Levofloxacin Na (Synthroid) Terazosin Hcl Paroxetine Hcl Nitroglycerin Hydralazine Hcl Doxepin Hcl Buspirone Hcl C C C C Date:04/07/99ISR Number: 3234475-0Report Type:Direct Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 5MG BID, 1-5 Hospitalization PRN Initial or Prolonged AGITATION; Company Report # PT Cough Report Source Report Source Product Role Haloperidol PS Lithium SS Nervous System Disorder Neuroleptic Malignant ADMIT Pyrexia ADMIT Route Company Report # PRIOR TO PRIOR TO Manufacturer C C C C C C C Movement Disorder Syndrome Route C C C Dyspnoea 300MG BID Manufacturer Date:04/07/99ISR Number: 3234909-1Report Type:Expedited (15-DaCompany Report #2553/12541 Age:20 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Aggression Initial or Prolonged Balance Disorder INTRAMUSCULAR 200-400 Clonic Convulsion MG-1Q3WK, IM Condition Aggravated ORAL Convulsion Drug Interaction Psychotic Disorder Report Source Product Role Health Professional Depo-Provera Suspension PS Lithium SS Depakote (Divalproex) Haldol (Haloperidol) Ritalin (Methylphenidate Hcl) Manufacturer Route ORAL SS SS C Date:04/08/99ISR Number: 3234973-XReport Type:Expedited (15-DaCompany Report #990329-008011259 Age:45 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 10 MG, QD, Initial or Prolonged ORAL 900 MG, QD 22-Aug-2005 Page: 110 10:48 AM PT Report Source Product Role Manufacturer Route Depressed Level Of Foreign Haloperidol Tablets PS ORAL Consciousness Health Syncope Professional Lithium Acetate SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Lorazepam SS ORAL Diclofenac Sodium SS ORAL Flunitrazepam SS ORAL Valproic Acid Lorazepam C C 1.5 MG, QD,ORAL 150 MG, QD, ORAL QD ORAL Date:04/08/99ISR Number: 3235226-6Report Type:Expedited (15-DaCompany Report #1999007311-1 Age:46 YR Gender:Female I/FU:I Outcome Dose Duration Death Hospitalization 800 Initial or Prolonged MILLIGRAMS 6 YR PT Report Source Product Role Manufacturer Abdominal Pain Blood Creatinine Literature Lithium Smithkline Beecham PS Smithkline Beecham Increased Blood Urea Increased Csf Glucose Abnormal Csf Protein Increased Depressed Level Of Consciousness Diarrhoea Hyperhidrosis Nausea Pyrexia Tachycardia Thyrotoxic Crisis Thyroxine Increased Vomiting White Blood Cell Count Increased Date:04/08/99ISR Number: 3235239-4Report Type:Expedited (15-DaCompany Report #1999007308-1 Age:57 YR Gender:Male I/FU:I Route Outcome Dose Duration Hospitalization Initial or Prolonged 1200 PT Report Source Product Role Manufacturer Blood Creatine Phosphokinase Increased Literature Lithium Smithkline Beecham PS Smithkline Beecham Blood Pressure MILLIGRAMS Fluctuation 400 Dysarthria MILLIGRAMS Dysphagia Mania Neuroleptic Malignant Syndrome Pyrexia Salivary Hypersecretion Sedation Tachycardia White Blood Cell Count Increased Date:04/08/99ISR Number: 3235247-3Report Type:Expedited (15-DaCompany Report #1999007306-1 Age:62 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 111 10:48 AM PT Akinesia Chills Delirium Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Disorientation Drug Interaction Dyskinesia Report Source Product Role Manufacturer Encephalopathy Fear Literature Health Lithium Smithkline Beecham PS Smithkline Beecham Hallucination Professional Biperiden Haloperidol Perazine Valproate C C C C Route Duration 450 MILLIGRAMS Muscle Rigidity 1125 Restlessness MILLIGRAMS Tardive Dyskinesia 675 Date:04/12/99ISR Number: 3237930-2Report Type:Expedited (15-DaCompany Report #9904507 Age: Gender:Male I/FU:F Outcome Dose Duration Required 900 MG TOTAL Intervention to TID ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Heart Rate Increased Consumer Lithane Tablets PS Lithium SS Manufacturer Route ORAL Date:04/13/99ISR Number: 3239176-0Report Type:Expedited (15-DaCompany Report #001-0945-990134 Age:20 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2700 MG (900 PT Report Source Product Role Bipolar Disorder Convulsion Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Dizziness MG, TID), PER Manufacturer Route ORAL Drug Interaction ORAL Drug Level Below Therapeutic Headache Lethargy Mania Status Epilepticus Date:04/14/99ISR Number: 3239791-4Report Type:Direct Age:84 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 450MG QD; FOR Initial or Prolonged SOME TIME PT Asthenia (Lithium) (Seroquel) Ambien (Zolpidem Tartrate Company Report # Report Source Product Role Lithium PS Synthroid Compazine C C Date:04/19/99ISR Number: 3242354-8Report Type:Expedited (15-DaCompany Report #8-99098-011A Age:32 YR Gender:Female I/FU:I 22-Aug-2005 Page: 112 10:48 AM C Confusional State Decreased Appetite Outcome Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage Dose PT Report Source Product Role Manufacturer Atrioventricular Block First Degree Coma Foreign Health Professional Effexor (Ventlafaxine Hydrochloride) PS ORAL Chloral Hydrate SS ORAL Lamotrigine SS ORAL Lithium SS ORAL Lorazepam SS ORAL Olanzepine SS ORAL Route Duration TABLETS, 1.05 Heart Rate Increased GRAMS ONCE Intentional Misuse ORAL Loss Of Consciousness 2.898 GRAMS Pneumonia Aspiration (1) TIME ORAL Sedation 3.5 GRAMS (1) TIME ORAL 5.6 GRAMS (1) TIME ORAL 28 MG (1) TIME ORAL 140 MG (1) TIME ORAL Date:04/19/99ISR Number: 3242383-4Report Type:Expedited (15-DaCompany Report #1999-04-0465 Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Apnoeic Attack Cerebellar Ataxia Coordination Abnormal Foreign Health Professional Trilafon (Perphenazine) Tablets PS ORAL Difficulty In Walking Other Litarex SS ORAL Panodil C 16 MG ORAL ORAL Dysarthria Dyspnoea Hyperventilation Neurotoxicity Pneumonia Pyrexia Sedation Snoring Visual Disturbance Bricanyl Powder Pulmicort Powder C C Date:04/20/99ISR Number: 3243298-8Report Type:Expedited (15-DaCompany Report #1999008279-1 Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 800 PT Report Source Product Role Manufacturer Antibody Test Positive Blood Thyroid Stimulating Literature Lithium Carbonate (Lithium) PS Smithkline Beecham Hormone Decreased MILLIGRAMS Goitre Hyperthyroidism Iodine Uptake Increased Palpitations Thyroxine Increased Tri-Iodothyronine Increased Weight Decreased 22-Aug-2005 Page: 113 10:48 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/20/99ISR Number: 3243300-3Report Type:Expedited (15-DaCompany Report #1999008680-1 Age:65 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300 Initial or Prolonged MILLIGRAMS, Other 2.0 DAILY PT Report Source Product Role Manufacturer Route Chronic Lymphocytic Health Eskalith PS Smithkline Beecham ORAL Leukaemia Professional Manufacturer Route Route Pneumonia Date:04/22/99ISR Number: 3244618-0Report Type:Direct Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report # PT Report Source Product Role Agitation Confusional State Dizziness Electrocardiogram Abnormal Feeling Abnormal Nausea Health Professional Lithium Paxil Insulin Lopid Ativan PS C C C C Date:04/23/99ISR Number: 3245877-0Report Type:Expedited (15-DaCompany Report #1999008544-2 Age:66 YR Gender:Male I/FU:I Outcome Dose Disability PT Report Source Product Role Manufacturer Dyskinesia Dystonia Movement Disorder Muscle Hypertrophy Neck Pain Paraproteinaemia Posturing Stereotypy Torticollis Literature Health Professional Lithium Antipsychotic Drugs (Nos) Benzhexol Botulinus Toxin Clonazepam Co-Careldopa Diazepam Methylprednisolone Nitrazepam Olanzapine Sulipride Tetrabenazine PS Smithkline Beecham Duration C C C C C C C C C C C Thioridazine Tricyclic Antidepressants (Nos) Trifluoperazine Date:04/26/99ISR Number: 3247053-4Report Type:Expedited (15-DaCompany Report #9915773 Age: Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 114 10:48 AM PT Anxiety Bronchospasm Decreased Appetite Depression Diplopia Dysphemia Endometriosis Feeling Abnormal Headache Hyperhidrosis Hysterectomy Insomnia C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Liver Function Test Abnormal Migraine Dose Report Source Product Role Zoloft Tablets PS Lithium St. John'S Wort Milk Thistle Premarin SS SS C C Manufacturer Route Duration Nausea ORAL 50.00 MG Nervous System Disorder TOTAL: DAILY: Tremor ORAL Vomiting Weight Decreased Date:04/29/99ISR Number: 3249988-5Report Type:Expedited (15-DaCompany Report #001-0945-990134 Age:20 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 2700 MG (900 PT Report Source Product Role Bipolar Disorder Convulsion Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Eskalith (Lithium Carbonate) Seroquel Ambien SS SS C Manufacturer Route ORAL Dizziness MG, TID) PER Drug Interaction ORAL Headache Lethargy Status Epilepticus Date:04/30/99ISR Number: 3251373-7Report Type:Direct Age:57 YR Gender:Male I/FU:I Outcome Dose Other PT Company Report # Report Source Product Role Lithium PS Duration Tremor Date:04/30/99ISR Number: 3251475-5Report Type:Direct Age:65 YR Gender:Male I/FU:I Company Report # Manufacturer Route Outcome Dose Duration Hospitalization 300MG , Initial or Prolonged DAILY, ORAL Required Intervention to Prevent Permanent Impairment/Damage PT Gait Disturbance 22-Aug-2005 Page: 115 10:48 AM Product Role Lithium PS Aspirin Clonazepam Bupropion (Wellbutrin) C C Manufacturer Route ORAL Lethargy Date:04/30/99ISR Number: 3251624-9Report Type:Direct Age:41 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 450MG, AT Initial or Prolonged BEDTI, ORAL Report Source PT Disorientation C Company Report # Report Source Product Role Lithium PS Oxazepam Insulin, Human 70/30 (Nph/Reg) Cisapride C Lethargy C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/99ISR Number: 3255768-7Report Type:Periodic Age:60 YR Gender:Male I/FU:I Outcome Dose Disability Other 1200 MG, Company Report #LITH002990006 PT Report Source Product Role Tooth Disorder Consumer Lithonate Capsules 300 Mg (Lithium Carbonate) PS Carbidopa Effexor Klonopin Levodopa Pramipexole Seroquel C C C C C C Manufacturer Route Duration ORAL PER ORAL Date:05/04/99ISR Number: 3253691-5Report Type:Expedited (15-DaCompany Report #FLUV00399000044 Age:37 YR Gender:Male I/FU:I Outcome Dose Other PO PT Report Source Product Role Fall Foreign Fevarin PS Grand Mal Convulsion Joint Dislocation Health Professional Leponex Hypnorex- Slow Release Gastrozepin SS Date:05/04/99ISR Number: 3255884-XReport Type:Periodic Age:53 YR Gender:Male I/FU:I Outcome Dose Other Manufacturer Route Duration ORAL SS C Company Report #18558-008 PT Report Source Product Role Manufacturer Route Blood Creatinine Increased Dysuria Consumer Lithium Carbonate Tablets PS Roxane Laboratories, Inc. ORAL Duration 600 MG BID PO 16 YR Depakote C Date:05/04/99ISR Number: 3255885-1Report Type:Periodic Age:46 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Amnesia Consumer Lithium Carbonate Tablets PS Roxane Laboratories, Nc. ORAL Duration 600 MG BID PO 6 YR Date:05/04/99ISR Number: 3255887-5Report Type:Periodic Age:45 YR Gender:Male I/FU:I Outcome Dose Other Company Report #18558-010 Company Report #18558-011 PT Report Source Product Role Manufacturer Route Headache Consumer Lithium Carbonate Tablets PS Roxane Laboratories Inc. ORAL Duration 300 MG AM, 900 MG PM PO 25 YR Aspirin Antihistamine 22-Aug-2005 Page: 116 10:48 AM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/04/99ISR Number: 3256590-8Report Type:Expedited (15-DaCompany Report #1999009592-1 Age:80 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 400 MILLIGRAMS PT Report Source Product Role Manufacturer Abdominal Pain Coordination Abnormal Literature Health Lithium Carbonate (Lithium) PS Smithkline Beecham Decreased Appetite Professional YR Diarrhoea Dizziness Drug Interaction Faecal Incontinence Irritable Bowel Syndrome Movement Disorder Nausea Oral Candidiasis Sedation Therapeutic Agent Toxicity Vomiting Carbamazepine Digoxin Hydrochlorothiazide/ Amiloride Local Anaesthetic Skin Infiltrations (Nos) Mebeverine Date:05/06/99ISR Number: 3255251-9Report Type:Direct Age:52 YR Gender:Female I/FU:I Outcome Dose Duration Required 300MG TID Intervention to ORAL Prevent Permanent Impairment/Damage C C C Company Report # Report Source Product Role Frequent Bowel Movements Health Lithium PS Heart Rate Increased Professional Manufacturer Route ORAL Hypercalcaemia Hyperthyroidism Palpitations Tremor Vision Blurred PT Duration C C PT Date:05/07/99ISR Number: 3256378-8Report Type:Direct Age:44 YR Gender:Male I/FU:I Outcome Dose Route Company Report # Report Source Product Role Manufacturer Route Hospitalization 900MG BID Initial or Prolonged Asthenia Lithium PS Bradycardia Disorientation Dizziness Lethargy Tremor Date:05/07/99ISR Number: 3256582-9Report Type:Expedited (15-DaCompany Report #1999008680-1 Age:65 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 300 Other MILLIGRAMS PT Report Source Product Role Manufacturer Route Chronic Lymphocytic Leukaemia Health Professional Eskalith Smithkline Beecham PS Smithkline Beecham ORAL Pneumonia Viral White Blood Cell Count 2.0 DAILY Increased ORAL 22-Aug-2005 Page: 117 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/99ISR Number: 3259258-7Report Type:Expedited (15-DaCompany Report #8-99117-162A Age:36 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRAVENOUS 100 MG Other DAILY IV PT Report Source Product Role Drug Interaction Gait Disturbance TWICE Hyporeflexia Foreign Health Bi-Profenid (Ketoprofen) PS Lithium Carbonate SS Propranolol Dihydroergotamine Mesilate C Manufacturer Route Professional Hypotonia 250 MG THREE Intervertebral Disc TIMES DAILY Protrusion Multiple Sclerosis Muscle Contractions Involuntary Myalgia Spinal Cord Compression Therapeutic Agent Toxicity Date:05/13/99ISR Number: 3260879-6Report Type:Direct Age:35 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged C Company Report # PT Report Source Product Role Manufacturer Route Hypercalcaemia Renal Failure Acute Health Professional Lithium Carbonate 300 Mg Capsules (Roxanne) PS Roxanne ORAL Ativan Trilafon C C 600MG PO BID Date:05/13/99ISR Number: 3261186-8Report Type:Expedited (15-DaCompany Report #1999010080-1 Age:43 YR Gender:Female I/FU:I Outcome Dose Other 1 GRAMS PT Report Source Product Role Manufacturer Route Lithium Smithkline Beecham PS Smithkline Beecham ORAL Duration Optic Neuritis Date:05/14/99ISR Number: 3262826-XReport Type:Expedited (15-DaCompany Report #1999007838-1 Age:28 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Abortion Spontaneous Alopecia Consumer Health Eskalith Smithkline Beecham PS Smithkline Beecham ORAL Depression Disorientation Professional Eskalith Smithkline Beecham SS Serzone Wellbutrin C C Duration ORAL ORAL 900 Dizziness MILLIGRAMS Drug Level Above ORAL Therapeutic Drug Level Below Therapeutic Fear Date:05/19/99ISR Number: 3265573-3Report Type:Expedited (15-DaCompany Report #9806748 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization ORAL Initial or Prolonged 22-Aug-2005 Page: 118 10:48 AM PT Report Source Product Role Serotonin Syndrome Health Lithane Tablets PS Professional Trilafon Klonopin Trazodone C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nardil C Date:05/20/99ISR Number: 3266123-8Report Type:Expedited (15-DaCompany Report #1999010856-1 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Drug Toxicity Nervous System Disorder Consumer Eskalith Beecham Role Manufacturer Route PS Smithkline Beecham ORAL Manufacturer Route Smithkline Zestril C Date:05/21/99ISR Number: 3267975-8Report Type:Expedited (15-DaCompany Report #9712480 Age:41 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 100.00 MG Initial or Prolonged TOTAL:DAILY:O PT Report Source Product Role Abdominal Distension Health Zoloft Tablets PS ORAL Alopecia Professional Lithium Carbonate SS ORAL Famotidine C Anger RAL Blood Lactate 900.00MG Dehydrogenase Increased TOTAL:TID:ORA Dizziness L Drug Ineffective Dry Mouth Face Oedema Headache Hyperhidrosis Hypoaesthesia Insomnia Periorbital Oedema Pollakiuria Salivary Hypersecretion Skin Odour Abnormal Tinnitus Tongue Oedema Urinary Incontinence Vision Blurred Date:05/25/99ISR Number: 3270013-4Report Type:Direct Age: Gender: I/FU:I Outcome Dose PT Company Report # Report Source Product Role Manufacturer Route Lithium Citrate Syrup Usp (8m Eq Of Lithium Per 5ml) PS Roxanne Lab Product Role Manufacturer Route Lithium Smithkline Beecham PS Smithkline Beecham ORAL Duration Anxiety Date:05/25/99ISR Number: 3275374-8Report Type:Expedited (15-DaCompany Report #1999010626-1 Age:53 YR Gender:Male I/FU:I Outcome Dose Death ORAL 22-Aug-2005 Page: 119 PT Report Source Duration Bipolar Disorder Oesophageal Carcinoma 5 MON 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/99ISR Number: 3270180-2Report Type:Expedited (15-DaCompany Report #9921021 Age:33 YR Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Role Anoxia Bronchospasm Coma Dyspnoea Haemoglobin Decreased Haemorrhage Hypoxia Oedema Peripheral Pain Post Procedural Complication Pulmonary Oedema Syncope Ventricular Fibrillation Literature Health Professional Zoloft Tablets Lithium Nortriptyline Buspirone Clonazepam Trazodone Carisoprodol Analgesic Lidocaine PS SS C C C C C C C Manufacturer Route Manufacturer Route Duration Date:05/28/99ISR Number: 3273385-XReport Type:Periodic Age:66 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report #LITH002980016 PT Report Source Product Role Confusional State Drug Level Above Therapeutic Health Professional Lithium Carbonate Capsules 300 Mg (Lithium Carbonate) PS Amitriptyline Prilosec Zestril C C C ORAL 600 MG, PER Tremor ORAL Date:05/28/99ISR Number: 3273387-3Report Type:Periodic Age:32 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report #LITH002980018 PT Report Source Product Mania Health Professional Lithium Carbonate Capsules 300 Mg Role Manufacturer Route (Lithium Carbonate) PS ORAL Prozac (Fluoxetine Hydrochloride) SS ORAL 600 MG, PER ORAL PER ORAL Date:05/28/99ISR Number: 3273389-7Report Type:Periodic Age:36 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG Company Report #LITH002980028 PT Report Source Product Role Manufacturer Route Depression Hypertonia Leukocytosis Health Professional Lithium Carbonate Capsules 300 Mg (Lithium) PS ORAL Luvox Tablets 50 Mg (Fluvoxamine Maleate) SS ORAL Risperdal (Risperidone) SS ORAL Thorazine (Chlorpromazine Hydrochloride) SS ORAL , PER Neuroleptic Malignant ORAL Syndrome Pyrexia Urinary Incontinence PER ORAL 4.5 MG , PER ORAL PER ORAL 22-Aug-2005 Page: 120 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Effexor Date:05/28/99ISR Number: 3273394-0Report Type:Periodic Age:72 YR Gender:Female I/FU:I Outcome Dose Other C Company Report #LITH002990001 PT Report Source Product Role Manufacturer Route Amnesia Diarrhoea Drug Interaction Health Professional Lithium Carbonate Capsules 300 Mg (Lithium Carbonate) PS ORAL Lisinopril (Lisinopril) SS ORAL Deltasone Fosamax Synthroid C C C Duration SEE IMAGE Drug Level Above Therapeutic 20 MG , PER ORAL Date:05/28/99ISR Number: 3273396-4Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LITH002980006 PT Report Source Product Role Cystitis Insomnia Pain Consumer Lithonate Capsules 300 Mg (Lithium Carbonate) PS Ativan C Manufacturer Route Duration ORAL 900 MG , PER Pollakiuria ORAL Date:05/28/99ISR Number: 3273400-3Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LITH002980008 PT Report Source Product Cardiomyopathy Health Professional Lithium Carbonate Capsules 300 Mg Duration Role Manufacturer Route (Lithium Carbonate) PS ORAL 300 MG, PER ORAL Date:05/28/99ISR Number: 3273402-7Report Type:Periodic Age:44 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LITH002980012 PT Report Source Product Role Asthenia Skin Disorder Skin Hypertrophy Consumer Lithium Carbonate Capsules 300 Mg (Lithium Carbonate) PS Klonopin Posicor C C Manufacturer Route Duration ORAL 1200 MG, PER DAY, PER ORAL Date:05/28/99ISR Number: 3273406-4Report Type:Periodic Age:36 YR Gender:Female I/FU:I Outcome Dose Other ORAL 22-Aug-2005 Page: 121 Company Report #LITH002980015 PT Report Source Product Role Bradycardia Health Lithium (Lithium) PS Electrocardiogram Abnormal Ventricular Extrasystoles Professional Manufacturer Route Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/99ISR Number: 3273410-6Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LITH002980022 PT Report Source Product Role Hormone Level Abnormal Oedema Peripheral Consumer Lithonate Capsules 300 Mg (Lithium Carbonate) PS Nardil C Manufacturer Route Duration ORAL 600 MG, PER DAY, PER ORAL Date:05/28/99ISR Number: 3273414-3Report Type:Periodic Age:77 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LITH002980030 PT Report Source Product Role Pain Weight Increased Consumer Lithonate Capsules 300 Mg (Lithium Carbonate) PS Manufacturer Route Duration ORAL 600 MG, PER ORAL Date:05/28/99ISR Number: 3273417-9Report Type:Periodic Age:41 YR Gender:Female I/FU:I Outcome Dose Other ORAL Company Report #LITH002980031 PT Report Source Product Role Manufacturer Route Dizziness Health Lithium (Lithium) PS ORAL Dyspnoea Weight Increased Professional Risperdal (Risperidone) SS ORAL Loestrin (Norethisterone Acetate, Ethinylestradiol) SS ORAL Duration 4 MG, PER ORAL ONE TABLET PER DAY, PER ORAL Date:05/28/99ISR Number: 3273422-2Report Type:Periodic Age:28 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LITH002990002 PT Report Source Product Role Dermatitis Vasodilatation Health Professional Lithonate Capsules 300 Mg (Lithium Carbonate) PS Alprazolam Neurontin C C Manufacturer Route Duration ORAL 600 MG, PER ORAL Date:06/01/99ISR Number: 3274621-6Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600 MG PO BID Initial or Prolonged 22-Aug-2005 Page: 122 10:48 AM PT Company Report # Report Source Product Role Coordination Abnormal Lithium PS Malaise Tremor Amlodipine Diphenhydramine Fluphenazine Decanoate C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/99ISR Number: 3275094-XReport Type:Expedited (15-DaCompany Report #1999007838-1 Age:28 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Abortion Spontaneous Affective Disorder Consumer Health Eskalith Smithkline Beecham PS Smithkline Beecham ORAL Alopecia Depression Professional Eskalith Smithkline Beecham SS Smithkline Beecham ORAL Serzone Wellbutrin C C Manufacturer Route Duration ORAL 900 MG ORAL Disorientation Dizziness Headache Nausea Stress Date:06/01/99ISR Number: 3275097-5Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 500 MG PO TID Company Report # PT Report Source Product Role Blood Creatinine Increased Health Professional Lithium Carbonate Divalproex Sodium PS SS Fluphenazine Diphenhydramine C C Blood Urea Increased Coordination Abnormal Drug Level Above Therapeutic Sedation Tremor Date:06/03/99ISR Number: 3275147-6Report Type:Direct Age:69 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization LONGTERM USE Initial or Prolonged BEFORE ADMIT PT Drug Toxicity Hypotension Mental Disorder ORAL Company Report # Report Source Product Role Lithium PS Manufacturer Route Date:06/03/99ISR Number: 3281437-3Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other ORAL Company Report #9827209 PT Report Source Product Role Manufacturer Route Dermatitis Consumer Lithane Tablets PS ORAL Zoloft SS ORAL Psyllium SS ORAL Aspirin SS ORAL Ecotrin Stool Disorders C C Duration Rash Maculo-Papular 50.00 MG Urticaria TOTAL; DAILY; ORAL ORAL ORAL Date:06/03/99ISR Number: 3281438-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other ORAL 22-Aug-2005 Page: 123 Company Report #9837369 PT Report Source Product Role Constipation Health Lithane Tablets PS Hypercholesterolaemia Upper Respiratory Tract Infection Professional Azmacort Klonopin Folic Acid Zyprexa C C C C Manufacturer Route Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/99ISR Number: 3281439-7Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Hypothyroidism Health Professional Lithane Tablets Synthroid Midrin Potassium Chloride Risperidol Carbidopa/Levodopa Permax Captopril PS C C C C C C C Manufacturer Route Manufacturer Route Duration Date:06/03/99ISR Number: 3281440-3Report Type:Periodic Age: Gender:Female I/FU:F Outcome Dose Other ORAL Company Report #9911960 Company Report #9808189 PT Report Source Product Role Drug Ineffective Health Lithane Tablets PS Professional Iron C Duration ORAL Date:06/04/99ISR Number: 3276168-XReport Type:Expedited (15-DaCompany Report #1999012249-1 Age:28 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 PT Report Source Product Role Manufacturer Aggression Bipolar Disorder Literature Lithium Carbonate (Lithium) PS Smithkline Beecham Brief Psychotic Disorder, MILLIGRAMS With Postpartum Onset Caesarean Section Paranoia Restlessness Sleep Disorder Date:06/04/99ISR Number: 3276169-1Report Type:Expedited (15-DaCompany Report #1999012134-1 Age:27 YR Gender:Female I/FU:I Route Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Aggression Brief Psychotic Disorder, With Postpartum Onset Disinhibition Euphoric Mood Fluid Retention Hallucination Hypomania Intensive Care Mania Oedema Peripheral Pregnancy On Oral Contraceptive Weight Increased Literature Health Professional Lithium Diazepam Oxazepam Risperidone Terazepam PS C C C C Smithkline Beecham Date:06/07/99ISR Number: 3277480-0Report Type:Direct Age:69 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 124 10:48 AM PT Accidental Overdose Asthenia Company Report # Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Confusional State Drug Level Above Therapeutic Dose Report Source Product Role Lithium PS Manufacturer Route Manufacturer Route Duration 300 MG T.I.D.; THERAPY: LONG TERM Date:06/07/99ISR Number: 3277713-0Report Type:Expedited (15-DaCompany Report #9906597 Age:44 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization ORAL Initial or Prolonged 600.00 MG PT Report Source Product Role Agitation Health Zoloft Tablets PS ORAL Drug Level Above Professional Lithobid SS ORAL Nausea Zyprexa SS ORAL Tremor Benztropine SS ORAL Wellbutrin Neurontin Klonopin Ambien C C C C Therapeutic TOTAL:DAILY:O Feeling Drunk RAL ORAL ORAL Date:06/10/99ISR Number: 3280563-2Report Type:Expedited (15-DaCompany Report #9822838 Age: Gender:Female I/FU:F Outcome Dose Duration Required ORAL Intervention to PT Report Source Product Role Cardiac Disorder Consumer Lithane Tablets PS Depression Manufacturer Route ORAL Prevent Permanent Impairment/Damage Ear Infection Hepatocellular Damage Medication Error Multiple Allergies Date:06/15/99ISR Number: 3285161-2Report Type:Expedited (15-DaCompany Report #1999CBX0001 Age:51 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Drug Level Above Therapeutic Literature Health Carbex (Selegiline Hcl) PS ORAL Drug Toxicity Professional (Lithium) SS ORAL Duration PO PO Date:06/16/99ISR Number: 3284095-7Report Type:Direct Age:48 YR Gender:Male I/FU:I Outcome Dose Death PT Company Report # Report Source Product Role Lithium PS Duration Demyelination Date:06/17/99ISR Number: 3286241-8Report Type:Expedited (15-DaCompany Report #LBID002990002 Age:44 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 125 10:48 AM PT Agitation Drug Level Above Therapeutic Drug Toxicity Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeling Drunk Nausea Tremor Dose Report Source Product Role Consumer Lithobid Tablets 300 Mg (Lithium Carbonate) PS ORAL Benzotropine (Benzatropine Mesilate) SS ORAL Neurontin (Gabapentin) SS ORAL Ambien (Zolpidem Tartrate) SS ORAL Buspar Lamictal Wellbutrin Zoloft Zyprexa C C C C C Manufacturer Route Duration 1200 MG, PER ORAL PER ORAL PER ORAL PER ORAL Date:06/18/99ISR Number: 3288485-8Report Type:Periodic Age:65 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LITT002980004 PT Report Source Product Role Manufacturer Route Depression Insomnia Nervousness Consumer Lithotabs Tablets 300 Mg (Lithium Carbonate) PS ORAL Lithobid Tablets 300 Mg (Lithium Carbonate) SS ORAL Duration 1050 MG , PER Pollakiuria ORAL 300 MG , PER ORAL Lithotabs Tablets 300 Mg (Lithium Carvbonate) SS Transene (Clorazepate Dipotassium) C 300 MG Date:06/18/99ISR Number: 3288487-1Report Type:Periodic Age:76 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LITT002980005 PT Report Source Product Role Diplopia Myasthenic Syndrome Neuropathy Peripheral Health Professional Lithotabs Tablets 300 Mg (Lithium Carbonate) PS Manufacturer Route Duration ORAL 900 MG , PER ORAL Date:06/18/99ISR Number: 3288491-3Report Type:Periodic Age:40 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LITT002990001 PT Report Source Product Role Abdominal Pain Pain Consumer Lithotabs Tablets 300 Mg (Lithium Carbonate) PS 600 MG , PER ORAL Lithotabs Tablets 300 Mg (Lithium 22-Aug-2005 Page: 126 Manufacturer Route Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Carbonate) SS ORAL 300 MG, PER ORAL Date:06/23/99ISR Number: 3289556-2Report Type:Direct Age:66 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Company Report # PT Report Source Product Sedation Consumer Mirapex Upjohn Role Manufacturer Route / 0.5mg / PS Upjohn ORAL 0.5MG / 5XD /PO 3 MON Eskalith Sr Mg / Po 450 MG / 450 SS ORAL / BID / PO Date:06/25/99ISR Number: 3293302-6Report Type:Expedited (15-DaCompany Report #PRIUSA1999002546 Age:30 YR Gender:Unknown I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Overdose Literature Health Haldol (Unspecified) (Haloperidol) PS ORAL Professional Fluoxetine (Fluoxetine) SS ORAL Lithium (Lithium) SS ORAL Duration ORAL ORAL ORAL Date:06/25/99ISR Number: 3295538-7Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report #LBID002990010 PT Report Source Product Drug Level Above Therapeutic Health Professional Lithobid Tablets 300 Mg (Lithium Role Manufacturer Route Carbonate) PS Naprosyn C ORAL 1200 MG, PER ORAL Date:06/25/99ISR Number: 3295540-5Report Type:Periodic Age:37 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID002980017 PT Report Source Product Role Abdominal Distension Acne Alopecia Consumer Lithobid Tablets 300 Mg (Lithium Carbonate) PS Inderal La Pravacol Synthroid C C C Manufacturer Route Duration ORAL 600 MG, PER Chills ORAL Confusional State Dehydration Dry Mouth Pollakiuria Date:06/25/99ISR Number: 3295542-9Report Type:Periodic Age:43 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID002980026 PT Report Source Product Role Tooth Discolouration Health Professional Lithobid Tablets 300 Mg (Lithium Carbonate) PS Azmacort Glucotrol C C 900 MG, PER ORAL 22-Aug-2005 Page: 127 Manufacturer Route Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/99ISR Number: 3295543-0Report Type:Periodic Age:37 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID002980029 PT Report Source Product Role Dyspepsia Hypersensitivity Urticaria Consumer Lithobid Tablets 300 Mg (Lithium Carbonate) PS Manufacturer Route Duration ORAL 900 MG, PER DAY, PER ORAL / 900 MG, PER ORAL Date:06/25/99ISR Number: 3295545-4Report Type:Periodic Age:17 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID002980031 PT Report Source Product Role Manufacturer Route Anxiety Headache Nausea Health Professional Lithobid Tablets 300 Mg (Lithium Carbonate) PS ORAL Zyprexa (Olanzapine) SS ORAL Duration 1200 MG, 2 IN Thinking Abnormal 1 D, PER ORAL Tremor 5 MG, PER ORAL Date:06/25/99ISR Number: 3295546-6Report Type:Periodic Age:45 YR Gender:Female I/FU:I Outcome Dose Other 600 MG, PER ORAL Company Report #LBID002980032 PT Report Source Product Role Hostility Insomnia Vasodilatation Consumer Lithobid Tablets 300 Mg (Lithium Carbonate) PS Manufacturer Route Duration ORAL Buspar Inderal Premarin Sinquan Zoloft Date:06/25/99ISR Number: 3295549-1Report Type:Periodic Age:63 YR Gender:Female I/FU:I Outcome Dose Other C C C C C Company Report #LBID002980036 PT Report Source Product Role Glossitis Headache Consumer Lithobid Tablets 300 Mg (Lithium Carbonate) PS Avapro Calcium Premarin Vitamin B Compex Vitamin E Ziac C C C C C C Manufacturer Route Duration ORAL 300 MG, PER ORAL 14 YR Date:06/25/99ISR Number: 3295550-8Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Drug Interaction Health Professional Lithobid Tablets 300 Mg (Lithium Carbonate) PS Manufacturer Route Duration 300 MG, PER 22-Aug-2005 Page: 128 Company Report #LBID002980037 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Nicoderm Cq (Nicotine) TOPICAL TOPICAL SS 21 MG, / 14 MG, TOPICAL Date:06/25/99ISR Number: 3295552-1Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID002990009 PT Report Source Product Role Glossitis Health Professional Lithobid Tablets 300 Mg (Lithium Carbonate) PS Manufacturer Route Duration ORAL 1200 MG, PER DAY, PER ORAL Date:06/25/99ISR Number: 3295554-5Report Type:Periodic Age:8 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LBID002990011 PT Report Source Product Role Accident Accidental Overdose Drug Level Above Health Professional Lithobid Tablets 300 Mg (Lithium Carbonate PS Manufacturer Route Duration 300 MG, PER Therapeutic ORAL Dysarthria Sedation Date:06/25/99ISR Number: 3295557-0Report Type:Periodic Age:54 YR Gender:Male I/FU:I Company Report #LBID002990012 ORAL Outcome Dose Other PT Report Source Product Role Constipation Fungal Skin Infection Pain Consumer Lithobid Tablets 300 Mg (Lithium Carbonate) PS Trilafon Valium C C Manufacturer Route Duration ORAL 600MG Q AM AND 900MG Q PM, PER ORAL Date:06/25/99ISR Number: 3295559-4Report Type:Periodic Age:46 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LBID002990013 PT Report Source Product Role Accident Diarrhoea Mydriasis Consumer Lithobid Tablets 300 Mg (Lithium Carbonate) PS Clonazepam C Manufacturer Route Duration ORAL PER ORAL Date:06/25/99ISR Number: 3295560-0Report Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Pruritus Rhinitis Weight Increased Consumer Lithobid Tablets 300 Mg (Lithium Carbonate) PS Duration STARTED ON 900 MG/D THEN DECREASED TO 22-Aug-2005 Page: 129 Company Report #LBID002990014 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 600 Zoloft Date:06/25/99ISR Number: 3295561-2Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other C Company Report #LBID002990016 PT Report Source Product Role Paraesthesia Health Professional Lithobid Tablets 300 Mg (Lithium Carbonate) PS Manufacturer Route Duration ORAL 1500 MG, PER ORAL Date:06/25/99ISR Number: 3295563-6Report Type:Periodic Age:81 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID002990017 PT Report Source Product Role Dementia Overdose Other Lithobid Tablets 300 Mg (Lithium Carbonate) PS Manufacturer Route Duration ORAL PER ORAL Date:06/25/99ISR Number: 3295565-XReport Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Other 300 MG QD PO Company Report #LBID00299000052 PT Report Source Product Role Cyst Consumer Lithobid PS Prozac Klonopin C C Dyspepsia Date:06/28/99ISR Number: 3292484-XReport Type:Direct Age: Gender: I/FU:I Company Report # Manufacturer Route ORAL Outcome Dose Other 600MG QHS PT Report Source Product Role Lithium PS Manufacturer Route Manufacturer Route Duration Chronic Obstructive Airways Disease Exacerbated Drug Level Above Therapeutic Pneumonia Date:06/28/99ISR Number: 3292494-2Report Type:Direct Age:78 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600MG PO BID Initial or Prolonged 22-Aug-2005 Page: 130 10:48 AM PT Asthenia Confusional State Decreased Appetite Dehydration Drooling Drug Toxicity Lethargy Parkinsonian Gait Pyrexia Sinus Bradycardia Tremor Company Report # Report Source Product Role Lithium 600mg Po Bid PS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/99ISR Number: 3292768-5Report Type:Expedited (15-DaCompany Report #9468/18276 Age:62 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged .25 MG-1Q1DY; PT Report Source Product Role Manufacturer Route Cardiac Ventriculogram Left Foreign Consumer Xanax Tablets (.25mg) PS ORAL Cardiomyopathy Company Echography Abnormal Representative Lormetazepam (1 Mg) SS ORAL Fluvoxamine (50 Mg) SS ORAL Lithium (250 Mg) SS ORAL Ramipril C ORAL 2 MG / DAY; Ejection Fraction ORAL Abnormal 50 MG/DAY; ORAL 1625 MG/DAY; ORAL Date:06/28/99ISR Number: 3292847-2Report Type:Expedited (15-DaCompany Report #WAES 99061391 Age:26 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Anticholinergic Syndrome 1 MG/TID/PO 1 DAY Initial or Prolonged Bowel Sounds Abnormal UNK / UNK / Bradykinesia PO 3 DAY Confusional State UNK / UNK / Coordination Abnormal UNK Delirium 0.5 MG / BID Disorientation / UNK 2 WK Drug Interaction UNK / UNK / Report Source Product Role Literature Tab Cogentin 1 Mg PS ORAL Health Tab Cogentin Unk SS ORAL Sertraline 200 Mg SS Haloperidol 0.5 Mg SS Haloperidol 9 Mg SS Professional Manufacturer Route Dry Mouth UNK Dry Skin Lithiumco3 600 Mg SS UNK / UNK / Gastrointestinal Motility UNK 2 DAY Disorder Lithiumco3 900 Mg UNK / UNK / Hallucination, Visual UNK 3 DAY Masked Facies Muscle Rigidity Mydriasis Neurotoxicity Parkinsonism Skin Warm Speech Disorder Tremor Date:06/28/99ISR Number: 3292864-2Report Type:Expedited (15-DaCompany Report #WAES 99061391 Age:26 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 131 10:48 AM PT Anticholinergic Syndrome Bowel Sounds Abnormal Bradykinesia Coordination Abnormal Delirium Disorientation Drug Interaction Dry Mouth Dry Skin Gastrointestinal Motility Disorder Hallucination Masked Facies Muscle Rigidity Mydriasis SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Parkinsonism Skin Warm Speech Disorder Report Source Product Role Tremor Literature Cogentin PS Sertraline Haloperidol SS SS Lithium SS Manufacturer Route Duration 1 MG ORAL TID Health PO 3 DAY Professional 0.5 MG 3 BID DAY Date:06/28/99ISR Number: 3293113-1Report Type:Expedited (15-DaCompany Report #10022424 Age:36 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10 MILLIGRAM, Other 4/1 DAY ORAL 1 PT Report Source Product Role Confusional State Drug Effect Increased Foreign Health Buspar Tabs (Buspirone Hci) PS Drug Interaction Professional Medication Error Tremor Lithium (Lithium Salts) SS Vomiting Temazepam Luvox Disulfiram Vitamin B6 C C C C Manufacturer Route ORAL YR Date:06/29/99ISR Number: 3293692-4Report Type:Direct Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300,G PO BID Initial or Prolonged PT Difficulty In Walking Lethargy Mental Impairment Company Report # Report Source Product Role Lithium 300mg PS Manufacturer Route ORAL Date:06/30/99ISR Number: 3295088-8Report Type:Expedited (15-DaCompany Report #99D--10493 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Agitation Anxiety Delirium Foreign Health Professional Ludiomil Film-Coated Tablet (Maprotiline Hydrochloride) PS ORAL Disorientation Other Hypnorex Retard Slow Release Tablet (Lithium Carbonate) SS ORAL Seroxat Unknown (Paroxetine Hydrochloride) SS ORAL Duration UNK, DAILY, ORAL 10 MON Restlessness Tremor UNK, UNK, ORAL 10 DAY 40 MG, DAILY, ORAL Date:06/30/99ISR Number: 3295092-XReport Type:Expedited (15-DaCompany Report #1195977A Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization UNKNOWN DOSE, Initial or Prolonged PO PT Report Source Product Role Drug Interaction Consumer Motrin Ib Product PS ORAL Lithium SS ORAL Therapeutic Paralysis 22-Aug-2005 Page: 132 10:48 AM Route Drug Level Above UNKNOWN DOSE, PO Manufacturer FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/99ISR Number: 3294896-7Report Type:Direct Age:39 YR Gender:Male I/FU:I Outcome Dose Duration Death 5MG BID, 10MG PT Company Report # Report Source Cold Sweat Product Role Haloperidol PS Lithium SS Manufacturer Route Coma HS Condition Aggravated ORAL 900MG PO BID Cyanosis Delusion Dermatitis Respiratory Distress Stridor Tremor Date:07/02/99ISR Number: 3296199-3Report Type:Direct Age:76 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Dermatitis 1 BID / TID Initial or Prolonged Pruritus ALT 15 MON Psoriasis Company Report # Report Source Product Role Health Lithium Carbonate PS Route Manufacturer Route Professional Date:07/06/99ISR Number: 3303064-1Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL Manufacturer Company Report #201181 PT Report Source Product Role Agitation Feeling Drunk Health Professional Klonopin Tablets (Clonazepam) PS ORAL Nausea Tremor Other Lithobid (Lithium Carbonate) 300 Mg SS ORAL 300 MG DAILY ORAL Zyprexa (Olanzapine) SS Benzotropine Wellbutrin Neurontin Ambien Zoloft C C C C C ORAL ORAL Date:07/15/99ISR Number: 3354302-0Report Type:Periodic Age:50 YR Gender:Male I/FU:I Outcome Dose Company Report #990421-SK285 PT Report Source Product Role Manufacturer Route Depression Health Celebrex PS ORAL Drug Interaction Professional Zoloft SS ORAL Lithium SS ORAL Digoxin C Duration PO PO PO Date:07/16/99ISR Number: 3305766-XReport Type:Expedited (15-DaCompany Report #9929900 Age: Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 133 10:48 AM PT Accident At Work Aggression Drug Ineffective Drug Interaction Fall Headache FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Irritability Laceration Medication Error Dose Report Source Product Role Manufacturer Consumer Zoloft Tablets PS ORAL Lithium SS ORAL Baby Aspirin C Route Duration 50.00MG TOTAL DAILY ORAL 100.00MG TOTAL DAILY ORAL Date:07/19/99ISR Number: 3306512-6Report Type:Expedited (15-DaCompany Report #9930980 Age:35 YR Gender:Male I/FU:I Outcome Dose Duration Required 50.00 MG Intervention to TOTAL: DAILY: Prevent Permanent ORAL Impairment/Damage PT Report Source Product Role Flushing Consumer Sinequan Capsules PS Lithium Cogentin Trilafon Prozac SS SS SS C Manufacturer Route ORAL Malaise Road Traffic Accident Vomiting Date:07/19/99ISR Number: 3306860-XReport Type:Expedited (15-DaCompany Report #8-99193-014A Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG DAILY Initial or Prolonged DISCONTINUED Other IN JAN. 1999; PT Report Source Product Role Acute Respiratory Health Effexor PS Distress Syndrome Professional Oedema Peripheral Manufacturer Route ORAL Pulmonary Oedema REINITIATED Sedation (DATE AND Sleep Apnoea Syndrome Lithium SS ORAL Weight Increased Temazepam SS ORAL Zyprexa (Olanzapine) Tablets SS ORAL Temazepam Zyprexa Lithium Depakote Lorazepam C C C C C ORAL 5 TO 7 DOSES DAILY ORAL "AS MUCH AS 25 MG PER DAY" ORAL Date:07/19/99ISR Number: 3306931-8Report Type:Expedited (15-DaCompany Report #99HQ-10291 Age:49 YR Gender:Male I/FU:I Outcome Disability 22-Aug-2005 Page: 134 PT C-Reactive Protein Increased Cerebellar Syndrome Chest Pain Coordination Abnormal Difficulty In Walking Dizziness Drug Level Above Therapeutic Drug Toxicity 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Dysarthria Dyspnoea Lobar Pneumonia Report Source Product Role Pneumonia Pneumococcal Pyrexia Red Blood Cell Foreign Literature Health Carbamazepine Unknown (Carbamazepine) PS Sedimentation Rate Professional Increased Tremor White Blood Cell Count Increased Other Manufacturer Route Manufacturer Route Duration 1200 MG, DAILY Lithium Unknown (Lithium Carbinate) Trifluperidol Unknown SS SS 1.5 MG, DAILY Date:07/19/99ISR Number: 3307341-XReport Type:Expedited (15-DaCompany Report #1191259A Age:68 YR Gender:Male I/FU:F Outcome Dose Death PT Report Source Product Role Completed Suicide Drug Level Above Therapeutic Literature Health Professional Unknown Acetaminophen Product PS ORAL Glyburide SS ORAL Amitriptyline Metformin Lithium Paroxetine Trazodone SS SS SS SS SS Duration PO 1 DAY PO 1 DAY Date:07/20/99ISR Number: 3307542-0Report Type:Expedited (15-DaCompany Report #PRIUSA1999002546 Age:30 YR Gender:Female I/FU:F Outcome Dose Duration Death ORAL Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Anticholinergic Syndrome Literature Haldol PS ORAL Coma Convulsion Health Professional Fluoxetine (Fluoxetine) SS ORAL Manufacturer Route Disseminated Lithium (Lithium) SS Intravascular Coagulation Drug Level Above Therapeutic Electrocardiogram Qrs Complex Prolonged Epistaxis Heart Rate Increased Hypotension Neuroleptic Malignant Syndrome Paralysis Flaccid Pulmonary Oedema Pupil Fixed Pyrexia Respiratory Rate Decreased Serotonin Syndrome Cogentin (Benzatropine Mesilate) Amoxicillin (Amoxicillin) SS ORAL Date:07/22/99ISR Number: 3309009-2Report Type:Expedited (15-DaCompany Report #1999017012-1 Age:72 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 135 10:48 AM PT Apraxia Blepharospasm SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Clonic Convulsion Confusional State Drug Level Above Report Source Product Role Manufacturer Therapeutic Foreign Lithium PS Smithkline Beecham Eyelid Disorder Literature Fall Health Gait Disturbance Professional Amlodipine Enalapril Levodopa-Benserazide C C C Route Duration 800 MILLIGRAMS; 1200 MILLIGRAMS Muscle Rigidity Tremor Vomiting Date:07/29/99ISR Number: 3313829-8Report Type:Expedited (15-DaCompany Report #8-99201-212A Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Drug Withdrawal Syndrome Mania Stress Foreign Study Effexor Tablets (Venlafaxine Hydrochloride) PS ORAL Clonazepam Oral SS ORAL SLOWLY Suicide Attempt TITRATED TO 75 MG DAILY, THEN SLOWLY TAPERED OFF 2 MG DAILY, TWENY 0.5 MG TABLETS TAKEN IN OVERDOSE ORAL Flunitrazepam Tablets SS ORAL Lithium SS ORAL Levothyroxine Ethinyl Estradiol Gestodene C C C TWENTY 2MG TABLETS (OVERDOSE AMOUNT) 900MG DAILY ORAL Date:07/30/99ISR Number: 3315076-2Report Type:Expedited (15-DaCompany Report #LBID00299000666 Age:38 YR Gender:Female I/FU:I Outcome Dose Duration Other 300 MG BID PO PT Report Source Product Role Abortion Spontaneous Health Lithobid PS ORAL Amyotrophic Lateral Professional Effexor Xr SS ORAL Alprazolam Trazodone C C 150 MG BID PO Sclerosis Extensor Plantar Response Hyperreflexia Insomnia Restlessness Vaginal Haemorrhage Date:07/30/99ISR Number: 3315299-2Report Type:Expedited (15-DaCompany Report #210600 Age:59 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 136 10:48 AM PT Abdominal Pain Balance Disorder Bipolar Disorder Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chest Discomfort Chest Pain Circulatory Collapse Dose Report Source Product Role Manufacturer Route Consumer Health Professional Lariam Tablets (Mefloquine Hydrochloride) 250 Mg PS ORAL Lithium (Lithium Nos) SS ORAL Lorazepam Atenolol C C Duration Coordination Abnormal Diarrhoea Disorientation Flatulence 250 MG 1 PER Hypersensitivity WEEK ORAL Insomnia Palpitations 300 MG DAILY Psychotic Disorder ORAL Pyrexia Syncope Tremor Vomiting Date:08/02/99ISR Number: 3321138-6Report Type:Periodic Age:42 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 3 TIMES DAILY Initial or Prolonged ORAL 5 YR Company Report #8-97273-045L PT Report Source Product Role Alopecia Consumer Pondimin PS Chest Pain Prozac SS Dyspnoea Migraine Oedema Tachycardia Lithium Xanax SS C Manufacturer Route ORAL Amnesia 3 DAILY Date:08/03/99ISR Number: 3316753-XReport Type:Expedited (15-DaCompany Report #210600 Age:59 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization - PT Report Source Product Abdominal Pain Consumer Lariam Tablets Role Manufacturer Route Initial or Prolonged Bipolar Disorder Chest Discomfort Chest Pain Health Professional (Mefloquine Hydrochloride) 250 Mg PS ORAL Lithium (Lithium Nos) SS ORAL Lorazepam Atenolol C C 250 MG 1 PER Circulatory Collapse WEEK ORAL Coordination Abnormal Diarrhoea 300 MG DAILY Drug Hypersensitivity ORAL Flatulence Insomnia Mania Medication Error Nausea Palpitations Pruritus Pyrexia Tremor Urticaria Vomiting Projectile White Blood Cell Count Increased 22-Aug-2005 Page: 137 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/05/99ISR Number: 3317528-8Report Type:Periodic Age:58 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 20 MG THREE Initial or Prolonged TIMES DAILY Company Report #8-97301-004L PT Report Source Product Role Hallucination Consumer Pondimin PS Buspar Eskalith Cr SS SS Paxil Phentermine SS SS Albuterol Sulfate Flovent Inhaler Klonopin Lasix Premarin Synthroid Zaroxolyn C C C C C C C Manufacturer Route ORAL Increased Appetite Insomnia ORAL 225MG IN THE A.M. AND 450MG H.S. 30 MG ONCE DAILY Date:08/05/99ISR Number: 3320199-8Report Type:Expedited (15-DaCompany Report #9933436 Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Required ORAL Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Amnesia Foreign Lithane Tablets PS Ecchymosis Polytraumatism Sleep Walking Spinal Fracture Literature Health Professional Diazepam C Manufacturer Route ORAL Date:08/06/99ISR Number: 3320670-9Report Type:Expedited (15-DaCompany Report #781/20667 Age:66 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening Other .5 PT Report Source Product Role Manufacturer Route Abdominal Pain Decreased Appetite Consumer Other Mirapex Tablets (.5 Mg) PS ORAL Eskalith SS ORAL Sinemet Cr C Drug Effect Decreased MG-5Q1DY;ORAL Sedation 450 MG 2Q1DY;ORAL Date:08/12/99ISR Number: 3326106-6Report Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose Other Company Report #17812-043 PT Report Source Product Role Manufacturer Acne Weight Increased Consumer Lithium Carbonate Capsules- Roxane Laboratories, Inc. PS Roxane Laboratories, Inc. Elavil Zoloft Ativan Lipitor Klonopin Depakote Pamate C C C C C C C Duration A) 450 MG BID B) 300 MG BID 22-Aug-2005 Page: 138 2 DAY 10:48 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/99ISR Number: 3326113-3Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose Other Company Report #17812-045 PT Report Source Product Role Manufacturer Route Hypersensitivity Consumer Lithium Carbonate Capsules, 300 Mg Roxane Laboratories, Inc. PS Roxane Laboratories, Inc. ORAL Duration 300 MG/DAY, PO Antibiotic (Unknown Name, Strength, Manufacturer) 1 SS MON Date:08/12/99ISR Number: 3326125-XReport Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Other Company Report #17812-047 PT Report Source Product Role Manufacturer Route Constipation Dysgeusia Flatulence Malaise Tongue Disorder Consumer Lithium Carbonate Capsules Usp, 300 Mg - Roxane Laboratories, Inc. PS Roxane Laboratories, Inc. ORAL Route Duration 600 - 900 MG DAILY PO Date:08/12/99ISR Number: 3326129-7Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other 300 MG TID Company Report #17812-049 PT Report Source Product Role Manufacturer Thrombocytopenia Health Professional Lithium Carbonate Capsules Usp, 300mg - Roxane Laboratories, Inc. PS Roxane Laboratories, Inc. Duration Inderal Ativan Date:08/12/99ISR Number: 3326134-0Report Type:Periodic Age:80 YR Gender:Female I/FU:I Outcome Dose Other C C Company Report #17812-050 PT Report Source Product Role Manufacturer Overdose Consumer Lithium Carbonate Capsules Usp, 150 Mg - Roxane Laboratories, Inc. PS Roxane Laboratories, Inc. Dyazide (Long Time) Tamoxifen Niacin Ecotrin Mellaril Antioxidants C C C C C C Duration 150 MG 1-2X DAILY 22-Aug-2005 Page: 139 10:48 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/99ISR Number: 3326139-XReport Type:Periodic Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report #17812-051 PT Report Source Product Role Manufacturer Amnesia Confusional State Nervousness Consumer Lithium Carbonate Capsules Usp 300 Mg Roxane Laboratories, Inc. PS Roxane Laboratories, Inc. Flomax Synthroid C C Route 600 MG AM, 300 MG PM Date:08/12/99ISR Number: 3326145-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #17812-052 PT Report Source Product Role Manufacturer Route Asthenia Paraesthesia Thirst Visual Disturbance Consumer Lithium Carbonate Capsules Usp 300 Mg Roxane Laboratories, Inc. PS Roxane Laboratories, Inc. ORAL Duration 600 MG QHS PO Synthroid Date:08/12/99ISR Number: 3326156-XReport Type:Periodic Age:95 YR Gender:Female I/FU:I Outcome Dose Other 300 MG QHS PO; SEVERAL YEARS C Company Report #17812-053 PT Report Source Product Role Manufacturer Route Hypersensitivity Consumer Lithium Capsules Usp 150 Mg Roxane Laboratories, Inc. PS Roxane Laboratories, Inc. ORAL Duration Zoloft Docusate Psyllium Aspirin Date:08/12/99ISR Number: 3326163-7Report Type:Periodic Age:45 YR Gender:Female I/FU:I Outcome Dose Other C C C C Company Report #17812-054 PT Report Source Product Role Manufacturer Route Confusional State Headache Consumer Lithium Carbonate Capsules Usp, 300 Mg - Roxane Laboratories, Inc. PS Roxane Laboratories, Inc. ORAL Duration 600 MG/ DAY ORAL Neurontin Synthroid Wellbutrin Zyrtec Zovirax 22-Aug-2005 Page: 140 10:48 AM C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/13/99ISR Number: 3325595-0Report Type:Expedited (15-DaCompany Report #8-99193-014A Age:54 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 300 MG DAILY; Initial or Prolonged DISCONTINUED Other IN, JAN. PT Report Source Product Role Manufacturer Route Acute Respiratory Health Effexor PS ORAL Distress Syndrome Professional Dyspnoea Lithium SS ORAL Ejection Fraction Temazepam SS ORAL Zyprexa (Olanzapine) Tablets SS ORAL Temazepam Zyprexa Lithium Depakote Lorazepam C C C C C Asthma Cardiac Failure 1999, Congestive REINITIATED UNKNOWN ORAL 5 T0 7 DOSES Abnormal DAILY ORAL Gout Hypertensive Heart " AS MUCH AS Disease 25 MG PER Hypoxia DAY" ORAL Oedema Oedema Peripheral Pulmonary Oedema Respiratory Failure Sedation Sleep Apnoea Syndrome Weight Increased Date:08/13/99ISR Number: 3325605-0Report Type:Expedited (15-DaCompany Report #LIT/99/00316/LEX Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 150 MG; ORAL Required PT Report Source Product Role Bipolar Disorder Clonic Convulsion Foreign Literature Clozapine (Clozapine) PS Coordination Abnormal Health Lithium Carbonate Manufacturer Route ORAL Intervention to 600 MG Prevent Permanent Impairment/Damage Drug Interaction Professional (Lithium Carbonate) SS Dyskinesia Gait Disturbance Hyperreflexia Mania Muscle Contractions Involuntary Neuropathy Peripheral Neurotoxicity Tremor Date:08/13/99ISR Number: 3326020-6Report Type:Expedited (15-DaCompany Report #1999016226-1 Age:21 YR Gender:Male I/FU:I Outcome Dose Duration Required 450 Intervention to MILLIGRAMS Prevent Permanent ORAL Impairment/Damage 900 PT Report Source Product Role Manufacturer Route Chest Pain Health Eskalith PS Smithkline Beecham ORAL Pleuritic Pain Professional Eskalith SS Smithkline Beecham ORAL Pepcid Ac C Sinus Arrhythmia MILLIGRAMS ORAL 22-Aug-2005 Page: 141 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/99ISR Number: 3327663-6Report Type:Expedited (15-DaCompany Report #ZA/99/00374/MELR Age:29 YR Gender:Female I/FU:I Outcome Dose Duration Death Hospitalization Initial or Prolonged 100 MG, PT Report Source Product Role Agitation Bipolar Disorder Extrapyramidal Disorder Foreign Health Professional Melleril Retard (Thioridazine Hydrochloride) PS Lithium (Lithium) SS Manufacturer Route ORAL Mania ORAL;, 300 Sudden Death MG, TWICE A DAY, ORAL;, 300 MG, ORAL; 800 MG, ONCE A DAY Akineton (Biperiden Hydrochloride) Rivotril (Clonazepam) Bactrim (Bactrim) Modecate Depot (Fluphenazine Decanoate) Date:08/17/99ISR Number: 3329308-8Report Type:Direct Age:39 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300MG BID Initial or Prolonged ORAL Disability 300MG HS ORAL Required Intervention to Prevent Permanent Impairment/Damage PT SS C C C Company Report # Product Role Lithium 300mg PS ORAL Heart Rate Increased Seroquel 300mg SS ORAL Hypertension Muscle Twitching Muscular Weakness Paralysis Ambien Depakote Paxil Synthroid C C C C Difficulty In Walking Report Source Manufacturer Route Dysphagia Tremor Tenormin Zestril C C Date:08/18/99ISR Number: 3328470-0Report Type:Expedited (15-DaCompany Report #10072981 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRAMUSCULAR PT Report Source Product Role Pancreatitis Foreign Health Professional Modecate Inj 25 Mg/Ml (Fluphenazine Decanoate) PS Lithium (Lithium Salts) SS Vitamin B Vitamin C Cod Liver Oil Atenolol C C C C Manufacturer Route 25 MILLIGRAM, 1/1 MONTH 800 MILLIGRAM, 1/1 DAY ORAL Date:08/19/99ISR Number: 3329645-7Report Type:Expedited (15-DaCompany Report #8-99201-212A Age: Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 142 10:48 AM PT Drug Withdrawal Syndrome Mania ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stress Suicide Attempt Dose Report Source Product Role Manufacturer Route Foreign Study Effexor Tablets (Venlafaxine Hydrochloride) PS ORAL Clonazepam Oral SS ORAL Flunitrazepam Tablets SS ORAL Lithium Oral SS ORAL Clonazepam Lithium Flunitrazepam Levothyroxine Ethinyl Estradiol Gestodene C C C C C C Duration SLOWLY TITRATED TO 75 MG DAILY, THEN SLOWLY TAPERED TO 2 MG DAILY, TWENTY 0.5 MG TABLETS TAKEN IN OVERDOSE ORAL TWENTY 2MG TABLETS (OVERDOSE AMOUNT) ORAL 900 MG DAILY ORAL Date:08/19/99ISR Number: 3331776-2Report Type:Periodic Age:38 YR Gender:Female I/FU:I Outcome Dose Duration Other 150 MG TWICE Company Report #8-99148-040A PT Report Source Product Role Manufacturer Route Abortion Health Effexor Xr Capsules PS ORAL Hyperreflexia Professional Lithobid (Lithium Carbonate) Tablets, Slow Release SS ORAL Lithobid Tablets, Slow Release Alprazolam Tablets Trazodone Tablets C C C DAILY THEN Insomnia TAPERED AND Nervousness DISCONTINUED , ORAL 600 MG DAILY ORAL Date:08/20/99ISR Number: 3331207-2Report Type:Expedited (15-DaCompany Report #781/20667 Age:66 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening Other .5 MG - 5 PT Report Source Product Sedation Health Professional Mirapex Mg) Role Manufacturer Route Tablets (.5 PS ORAL SS ORAL Other Q1DY; ORAL Eskalith 450 MG 2QD1DY; ORAL Sinemet Cr 25/100 22-Aug-2005 Page: 143 10:48 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/24/99ISR Number: 3333038-6Report Type:Direct Age:66 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 500 MG Q AM ; Initial or Prolonged 600MG PO QPM PT Company Report # Report Source Coordination Abnormal Product Role Lithium Carbonate PS Aspirin Clonazepam Nph Insulin Verapamil Glipizide-Xl C C C C C Manufacturer Route ORAL Drug Level Above Therapeutic Date:08/26/99ISR Number: 3335613-1Report Type:Expedited (15-DaCompany Report #ZA/99/00374/MELR Age:29 YR Gender:Female I/FU:F Outcome Dose Death PT Report Source Product Role Sudden Death Foreign Health Professional Melleril Retard (Thioridazine Hydrochloride) PS Lithium (Lithium) SS Akineton (Biperiden Hydrochloride) Rivotril Bactrim Modecate Depot Decanoate SS C C C C Manufacturer Route Duration 100 MG, ORAL;, 300 MG, TWICE A DAY, ORAL;, 300 MG, 800 MG, ONCE A DAY ORAL Date:08/30/99ISR Number: 3336243-8Report Type:Direct Age:38 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 400MG AM/ Hospitalization 500MG HS ORAL Initial or Prolonged 450MG BID PT Company Report # Report Source Grand Mal Convulsion Product Role Clozaril PS Lithium SS Manufacturer Route ORAL Date:08/30/99ISR Number: 3337816-9Report Type:Expedited (15-DaCompany Report #10086304 Age:17 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 2 WK Initial or Prolonged Other 22-Aug-2005 Page: 144 10:48 AM PT Report Source Product Role Cardiovascular Disorder Confusional State Literature Health Prolixin(Fluphenazin e Hcl) PS Disorientation Dystonia Hypertonia Lethargy Mental Impairment Muscle Rigidity Neuroleptic Malignant Syndrome Overdose Suicide Attempt Tachycardia Professional Cogentin(Benztropine Mesylate) Lithium Carbonate SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/99ISR Number: 3339371-6Report Type:Expedited (15-DaCompany Report #99J--10260 Age:33 YR Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Role Blood Gases Abnormal Blood Pressure Diastolic Increased Foreign Health Professional Anafranil Tablet (Clomipramine Hydrochloride) PS ORAL Limas Tablet (Lithium Carbonate) SS ORAL Manufacturer Route Duration 242 DF, Cardiac Arrest DAILY, ORAL Coma Electrocardiogram 206 DG, Abnormal DAILY, ORAL Heart Rate Increased Hypotension Mydriasis Oliguria Ventricular Fibrillation Date:08/31/99ISR Number: 3337231-8Report Type:Direct Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 6MG HS ORAL Hospitalization 300MG BID Initial or Prolonged ORAL PT Company Report # Report Source Product Role Akinesia Risperidone PS ORAL Aphasia Lithium SS ORAL Levothyroxine C Catatonia Coma Confusional State Dysphagia Extrapyramidal Disorder Joint Stiffness Labile Blood Pressure Laryngospasm Leukocytosis Liver Function Test Abnormal Muscle Rigidity Neuroleptic Malignant Manufacturer Route Syndrome Parkinsonism Proteinuria Pulmonary Congestion Pyrexia Speech Disorder White Blood Cell Count Increased Date:09/02/99ISR Number: 3339917-8Report Type:Expedited (15-DaCompany Report #210600 Age:59 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 145 10:48 AM PT Abdominal Pain Bipolar Disorder Chest Discomfort Chest Pain Circulatory Collapse Coordination Abnormal Diarrhoea Drug Hypersensitivity Flatulence Insomnia Mania FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Palpitations Pruritus Pyrexia Dose Report Source Product Role Manufacturer Route Consumer Health Professional Lariam Tablets (Mefloquine Hydrochloride) 250 Mg PS ORAL Lithium (Lithium Nos) SS ORAL Lorazepam Atenolol C C Duration Tremor Urticaria Vomiting Projectile White Blood Cell Count 250 MG 1 PER Increased WEEK ORAL 300 MG DAILY ORAL Date:09/07/99ISR Number: 3342051-4Report Type:Expedited (15-DaCompany Report #9937194 Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 800.00 MG Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Apraxia Foreign Lithane Tablets PS ORAL Bipolar Disorder Literature Blepharospasm Health Amlodipine SS ORAL Clonic Convulsion Professional Haloperidol SS ORAL Enalapril Levothyroxine Levodopa/Benserazide Pergolide C C C C ORAL ORAL 6 YR Confusional State Difficulty In Walking Disorientation Drug Toxicity Eyelid Function Disorder Fall Gait Disturbance Hyperreflexia Memory Impairment Muscle Rigidity Poverty Of Speech Tremor Vomiting Date:09/09/99ISR Number: 3343608-7Report Type:Direct Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT 22-Aug-2005 Page: 146 10:48 AM Report Source Confusional State Coordination Abnormal Hallucination Renal Failure Chronic Tremor Date:09/10/99ISR Number: 3345188-9Report Type:Direct Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Company Report # PT Confusional State Diabetes Insipidus Hypothyroidism Sedation Product Role Lithium Hctz PS SS Manufacturer Route Manufacturer Route Company Report # Report Source Product Role Lithium PS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/10/99ISR Number: 3345241-XReport Type:Direct Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Role Lithium PS Product Role Neurotoxicity Renal Failure Acute Health Professional Lithium PS PT Cholecystectomy Route Manufacturer Route Manufacturer Route Manufacturer Route Company Report # Report Source Diabetes Insipidus PT Manufacturer Company Report # Report Source Date:09/16/99ISR Number: 3347862-7Report Type:Direct Age:15 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 450MG BID Product PT Date:09/11/99ISR Number: 3345550-4Report Type:Direct Age:76 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged Report Source Confusional State Convulsion Lethargy Date:09/10/99ISR Number: 3345270-6Report Type:Direct Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Company Report # Product Role Lithium PS Company Report # Report Source Product Role Eskalith 450mg -Oral PS ORAL Initial or Prolonged Other Required Intervention to Prevent Permanent Impairment/Damage Cholelithiasis Date:09/20/99ISR Number: 3351752-3Report Type:Expedited (15-DaCompany Report #9938803 Age:65 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 147 10:48 AM PT Ammonia Increased Blood Creatine Phosphokinase Increased Clonic Convulsion Coma Convulsion Decreased Appetite Depressed Level Of Consciousness Diarrhoea Drug Level Above FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Therapeutic Drug Toxicity Electrocardiogram T Wave Inversion Report Source Product Role Electroencephalogram Foreign Lithane Tablets PS ORAL Abnormal Literature Chlorpromazine SS ORAL Levomepromazine SS ORAL Phenobarbiton SS Manufacturer Route Duration 200.00 MG TOTAL: ORAL Gait Disturbance 25.00 TOTAL: Hyporeflexia ORAL Hypotonia 10.00 MG Liver Function Test TOTAL: ORAL Abnormal 200.00 MG Medication Error INTRAMUSCULAR TOTAL: Memory Impairment INTRAMUSCULAR 3 DAY Visual Disturbance Date:09/20/99ISR Number: 3352509-XReport Type:Expedited (15-DaCompany Report #1997023054-1 Age:59 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Alpha 2 Globulin Increased Literature Health Lithium Carbonate (Lithium) PS Smithkline Beecham Blood Albumin Decreased Professional Clopixol (Clopenthixol Decanoate) C Duration 600 MILLIGRAMS 7 YR Diarrhoea Drug Level Above Therapeutic Drug Toxicity Dysarthria Glomerulonephritis Minimal Lesion Lethargy Muscle Twitching Nephrotic Syndrome Oedema Route Oedema Peripheral Proteinuria Restlessness Tremor Date:09/21/99ISR Number: 3352831-7Report Type:Direct Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Confusional State Mental Impairment Health Professional Lithium Cn750 PS Date:09/21/99ISR Number: 3352948-7Report Type:Direct Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 148 10:48 AM Company Report # PT Drug Toxicity Fall Sedation Thirst Manufacturer Route Manufacturer Route Company Report # Report Source Product Role Lithium Thiazide Duriter PS C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/99ISR Number: 3353037-8Report Type:Direct Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600MG PO BID Initial or Prolonged PT Company Report # Report Source Confusional State Product Role Lithium Carbonate PS Manufacturer Route ORAL Drug Level Above Therapeutic Feeling Jittery Date:09/21/99ISR Number: 3353511-4Report Type:Expedited (15-DaCompany Report #1999023291-1 Age:65 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Clonic Convulsion Convulsion Decreased Appetite Literature Lithium Carbonate (Lithium) Smithkline Beecham PS Smithkline Beecham ORAL Chlorpromazine Levomepromazine C C Manufacturer Route 200 Dementia MILLIGRAMS Depressed Level Of ORAL 8 YR Consciousness Diarrhoea Electrocardiogram T Wave Inversion Electroencephalogram Abnormal Gait Disturbance Hyporeflexia Hypotonia Memory Impairment Visual Disturbance Date:09/21/99ISR Number: 3353538-2Report Type:Expedited (15-DaCompany Report #PRIUSA1999005952 Age:20 YR Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Blood Creatinine Literature Haldol (Unspecified) Duration Role Increased Health Blood Potassium Increased Professional (Haloperidol) PS ORAL Lithium SS ORAL 10 MG, 4 IN 1 DAILY, ORAL Blood Pressure Systolic 600 MG, 3 IN Decreased 1 DAILY, ORAL Cardiac Arrest Circulatory Collapse Coma Dehydration Drug Level Above Therapeutic Haemodialysis Heart Rate Increased Hypernatraemia Medication Error Date:09/22/99ISR Number: 3355340-4Report Type:Expedited (15-DaCompany Report #99D--10840 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Arrhythmia Atrioventricular Block Foreign Health Tegretal Tablet (Carbamazepine) PS Bundle Branch Block Left Professional Lithium Unknown (Lithium Carbonate) SS ORAL 22-Aug-2005 Page: 149 Manufacturer Route Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/99ISR Number: 3359275-2Report Type:Periodic Age:43 YR Gender:Female I/FU:I Outcome Dose Other DAILY: ORAL Company Report #9828185 PT Report Source Product Role Manufacturer Route Endocrine Disorder Consumer Navane Capsules PS ORAL Lithium SS ORAL Duration Neoplasm ORAL Tremor Date:09/22/99ISR Number: 3359285-5Report Type:Periodic Age:57 YR Gender:Female I/FU:I Outcome Dose Other 5.00 MG Company Report #9844382 PT Report Source Product Role Libido Decreased Health Navane Capsules PS Lithium SS Manufacturer Route Duration ORAL Professional TOTAL:DAILY:O RAL 900.00 MG TOTAL:DAILY Date:09/23/99ISR Number: 3356751-3Report Type:Expedited (15-DaCompany Report #8-99257-129A Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other SEE IMAGE PT Report Source Product Role Agitation Clonic Convulsion Condition Aggravated Foreign Literature Efexor Tablets (Venlafaxine Hydrochloride) PS Confusional State Depressed Mood Lithicarb (Lithium Carbonate) SS Depression Drug Interaction Emotional Distress Expressive Language Lithicarb C SEE IMAGE Manufacturer Route ORAL Disorder Hyperhidrosis Hyperreflexia Hypertonia Insomnia Obsessive-Compulsive Disorder Palpitations Restlessness Serotonin Syndrome Tachycardia Tremor Trismus Date:09/27/99ISR Number: 3359315-0Report Type:Expedited (15-DaCompany Report #8323/17892 Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL Other PT Report Source Product Role Manufacturer Route Dermatitis Foreign Health Halcion Tablets (.25 Mg) PS ORAL Professional Company Carbamazepine (600 Mg) SS ORAL Representative Levomepromazine (600 Mg) SS ORAL Lithium Carbonate (600 Mg) SS ORAL Nitrazepam (600 Mg) SS ORAL ORAL ORAL ORAL ORAL 22-Aug-2005 Page: 150 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/99ISR Number: 3360064-3Report Type:Expedited (15-DaCompany Report #210600 Age:59 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Abdominal Pain Bipolar Disorder Chest Discomfort Chest Pain Consumer Health Professional Lariam Tablets (Mefloquine Hydrochloride) 250 Mg PS ORAL Coordination Abnormal Diarrhoea Lithium (Lithium Nos) SS ORAL Disorientation Drug Hypersensitivity Insomnia Mania Palpitations Pruritus Psychotic Disorder Pyrexia Tremor Urticaria Vomiting Vomiting Projectile White Blood Cell Count Increased Lorazepam (Lorazepam) Atenolol (Atenolol) C C 250 MG 1 PER Circulatory Collapse WEEK 300 MG DAILY Date:09/29/99ISR Number: 3360219-8Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization PO BID 1 YR Initial or Prolonged Company Report # PT Report Source Product Role Nephrogenic Diabetes Health Lithium 800mg PS Insipidus Professional Date:09/30/99ISR Number: 3362043-9Report Type:Expedited (15-DaCompany Report #WAES 99069204 Age:72 YR Gender:Female I/FU:F Manufacturer Route ORAL Outcome Dose Duration Hospitalization Initial or Prolonged PO PT Report Source Product Role Manufacturer Route Amnesia Apraxia Foreign Literature Tab Vasotec (Enalapril Maleate) PS ORAL Blepharospasm Clonic Convulsion Health Professional Tab Benserazide/Levodopa SS ORAL Confusional State Disorientation Tab Lithium Carbonate Tablets SS ORAL Drug Effect Decreased Drug Toxicity Eyelid Disorder Fall Gait Disturbance Hyperreflexia Muscle Rigidity Speech Disorder Tremor Vomiting Amlodipine Levothyroxine Na Pergolide C C C 300/75 MG PO 1200 MG PO 22-Aug-2005 Page: 151 121 DAY 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/99ISR Number: 3362900-3Report Type:Expedited (15-DaCompany Report #210600 Age:59 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Abdominal Pain Bipolar Disorder Chest Discomfort Circulatory Collapse Consumer Health Professional Lariam Tablets (Mefloquine Hydrochloride) 250 Mg PS ORAL Lithium (Lithium Nos) SS ORAL Lorazepam (Lorazepam) Atenolol (Atenolol) C C 250 MG 1 PER Condition Aggravated WEEK ORAL Coordination Abnormal Diarrhoea 300 MG DAILY Dry Skin ORAL Flatulence Hypersensitivity Insomnia Palpitations Pruritus Pyrexia Tremor Urticaria Vomiting Vomiting Projectile White Blood Cell Count Increased Date:10/04/99ISR Number: 3363292-6Report Type:Expedited (15-DaCompany Report #JRFBEL1999001314 Age:68 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged MG, DAILY, Required ORAL Intervention to Prevent Permanent MG, DAILY, Impairment/Damage ORAL PT Report Source Product Role Cerebral Infarction Crying Foreign Health Risperidone (Tablet) (Risperidone) PS ORAL Delirium Professional Lithium Carbonate (Lithium Carbonate) SS ORAL Dialysis Drug Level Above Therapeutic Manufacturer Route Dysarthria Faecal Incontinence Gait Disturbance Inadequate Diet Insomnia Iron Deficiency Anaemia Logorrhoea Medication Error Renal Impairment Restlessness Therapeutic Agent Toxicity Thirst Tremor Trihexyphenidyl Hydrochloride Brotizolam Zopiclone Aniracetam Furosemide Allopurinol Probucol Flunitrazepam Temocapril Hydrochloride Date:10/04/99ISR Number: 3364380-0Report Type:Expedited (15-DaCompany Report #HQ0514128SEP1999 Age:38 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 152 10:48 AM PT Agitation Autonomic Nervous System Imbalance Confusional State Delirium Disorientation C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Drug Interaction Drug Toxicity Drug Withdrawal Syndrome Report Source Product Role Nausea Nocturia Health Professional Effexor (Venlafaxine Hydrochloride) PS Polydipsia Polyuria Effexor (Venlafaxine Hydrochloride) SS Psychomotor Hyperactivity Lithium (Lithium) SS Lithium (Lithium) SS Panadeine Forte Rohypnol C C Manufacturer Route Duration ORAL ORAL 75 MG 58 DAY ORAL 1750 MG 1 X Serotonin Syndrome PER 1 DAY Tremor ORAL 750 MG 2X PER 1 DAY Date:10/05/99ISR Number: 3368016-4Report Type:Periodic Age:45 YR Gender:Female I/FU:I Outcome Dose Other ORAL Company Report #8-99230-153A PT Report Source Product Role Drug Interaction Health Premarin Tablets PS Professional Lithobid (Lithium) SS Manufacturer Route Duration 3 DAY Date:10/06/99ISR Number: 3365433-3Report Type:Direct Age:52 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Accidental Overdose Initial or Prolonged Blood Magnesium Decreased 300MG PO QID 9 DAY Blood Pressure Decreased Dehydration 3-4PRN DOSES Company Report # Report Source Product Role Manufacturer Route Health Professional Lithium Carb. 300mg, Roxane 0054-8527-25 PS Roxanne ORAL Thioridazine 200mg 51079-580-20 SS Depressed Level Of EACH Consciousness Drug Level Above Therapeutic Sedation Urinary Retention Chlorpromazine 100mg 51079-130-20 SS Date:10/06/99ISR Number: 3366057-4Report Type:Expedited (15-DaCompany Report #1999023009-1 Age:59 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Lipase Increased Pancreatitis Health Professional Quilonum Retard (Lithium) Smithkline Beecham PS Smithkline Beecham ORAL Duration 18.3 MILLIMOLES ORAL Antihistamine, Nos Cholspasmin (Hymecromone) Date:10/06/99ISR Number: 3366059-8Report Type:Expedited (15-DaCompany Report #1999019384-1 Age:40 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 153 10:48 AM PT Bradycardia Circulatory Collapse Hypoglycaemia C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotension Dose Report Source Product Role Manufacturer Route Health Professional Quilonum Retard (Lithium) Smithkline Beecham PS Smithkline Beecham ORAL Manufacturer Route Duration 675 MILLIGRAMS ORAL Dominal Forte (Prothipendyl) Eunerpan (Melperon) Euthyrox (Levothyroxin-Sodium ) Date:10/07/99ISR Number: 3365595-8Report Type:Direct Age:69 YR Gender:Male I/FU:I Outcome Dose PT C C C Company Report # Report Source Product Role Decreased Appetite Lithium Carbonate PS Drug Level Above Therapeutic Drug Toxicity Gait Disturbance Lethargy Pneumonia Pse Apap Terazodin Oxybutynin Risperidone Levothyroxine Lithium C C C C C C C Duration ORAL 150MG PO Date:10/07/99ISR Number: 3366418-3Report Type:Direct Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600MG IN AM Company Report # PT Report Source Product Role Blood Potassium Decreased Drug Level Above Health Professional Lithium Carbonate 300mg PS Manufacturer Route Therapeutic 900 MG IN PM Date:10/07/99ISR Number: 3367613-XReport Type:Expedited (15-DaCompany Report #PRIUSA1999006543 Age:31 YR Gender:Unknown I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Completed Suicide Drug Level Above Literature Health Haldol (Unspecified) (Haloperidol) PS ORAL Therapeutic Professional Lithium (Lithium) SS ORAL Fluoxetine (Fluoxetine) SS ORAL Duration ORAL ORAL Intentional Self-Injury ORAL Date:10/08/99ISR Number: 3368321-1Report Type:Direct Age:69 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization PTA-LONG TERM Initial or Prolonged 22-Aug-2005 Page: 154 10:48 AM Company Report # PT Report Source Product Role Agitation Health Lithium Carbonate PS Decreased Activity Oral Intake Reduced Professional Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/99ISR Number: 3368977-3Report Type:Expedited (15-DaCompany Report #1999008680-1 Age:65 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 300 Other MILLIGRAMS PT Report Source Product Role Manufacturer Route Arthropathy Chronic Lymphocytic Health Professional Eskalith Smithkline Beecham PS Smithkline Beecham ORAL Manufacturer Route Leukaemia Leukocytosis 2.0 DAILY Pneumonia Viral ORAL Surgery Date:10/08/99ISR Number: 3369023-8Report Type:Expedited (15-DaCompany Report #PRIUSA1999006689 Age:70 YR Gender:Unknown I/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Intentional Self-Injury Literature Health Haldol (Unspecified) (Haloperidol) PS ORAL Professional Hydrochlorothiazide / Troamterence (Dyazide) SS ORAL Lithium (Lithium) SS ORAL Duration ORAL ORAL ORAL Date:10/12/99ISR Number: 3370755-6Report Type:Expedited (15-DaCompany Report #9912255 Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 500.000 MG PO Initial or Prolonged BID PT Report Source Product Role Manufacturer Route Hyponatraemia Foreign Abbott-Depakote PS Abbott ORAL Pituitary Tumour Health Polydipsia Polyuria Professional Lithium SS Date:10/14/99ISR Number: 3372131-9Report Type:Direct Age:69 YR Gender:Female I/FU:I Outcome Dose Other PO PT Company Report # Report Source Product Role Coordination Abnormal Lithium PS Mental Impairment Eskalith C Manufacturer Route Duration ORAL Date:10/14/99ISR Number: 3372976-5Report Type:Expedited (15-DaCompany Report #1999026279-1 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Hepatic Neoplasm Malignant Consumer Eskalith Smithkline Beecham PS Smithkline Beecham ORAL Manufacturer Route Duration 1.0 DAILY ORAL 31 YR Date:10/15/99ISR Number: 3374053-6Report Type:Expedited (15-DaCompany Report #HQ1758108OCT1999 Age:75 YR Gender:Male I/FU:I Outcome Dose Disability PT Report Source Product Role Drug Interaction Haemorrhage Health Professional Effexor (Venlafaxine Hydrochloride) PS ORAL Hypertensive Crisis Medication Error Aurorix (Moclobemide) SS ORAL Peripheral Ischaemia Lithium (Lithium) SS ORAL Duration ORAL ORAL ORAL 22-Aug-2005 Page: 155 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/99ISR Number: 3375657-7Report Type:Periodic Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 100.000 MG Company Report #990713-SK942 PT Report Source Product Role Manufacturer Route Drug Interaction Health Celebrex PS ORAL Eskalith SS ORAL Carbamazepine Olanzapine Levothyroxine C C C Professional BID PO 6 MON 450.000 MG QD PO Date:10/18/99ISR Number: 3376898-5Report Type:Periodic Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization PO Initial or Prolonged 675.000 MG Company Report #990913-SK052 PT Report Source Product Role Manufacturer Drug Interaction Consumer Celebrex PS ORAL Lithium SS ORAL Calcium Alendronate Propoxyphene Acetaminophen Omeprazole Levothyroxine C C C C C C Route BID PO Date:10/20/99ISR Number: 3376225-3Report Type:Direct Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 450 PO BID Company Report # PT Report Source Product Role Diarrhoea Health Eskalith Cr PS Manufacturer Route ORAL Initial or Prolonged CHRONIC BUT Disorientation Professional Drug Level Above ADJUSTED 3 Therapeutic WKS AGO 3 WK Lethargy Lung Infiltration Mania Mental Impairment Pneumonia Aspiration Vomiting Depakote Clonazepam Risperdal C C C Date:10/20/99ISR Number: 3377208-XReport Type:Expedited (15-DaCompany Report #9944064 Age: Gender: I/FU:I Outcome Dose Duration Required ORAL Intervention to ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Sideroblastic Anaemia Foreign Lithane Tablets PS ORAL Health Fluoxetine SS ORAL Professional Date:10/22/99ISR Number: 3379439-1Report Type:Expedited (15-DaCompany Report #9943368 Age:55 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 156 10:48 AM PT Alcoholism Back Pain Circadian Rhythm Sleep Disorder Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Condition Aggravated Delusion Depression Report Source Product Role Emotional Disorder Foreign Procardia Capsules PS ORAL Grandiosity Literature Hypomania Health Impulsive Behaviour Professional Lithium SS ORAL Ibuprofen SS ORAL Naproxen SS ORAL Hydrochlorothiazide Atenolol Ranitidine Nitroglycerine Moperone Alprazolam Lorazepam C C C C C C C Manufacturer Route Duration 30.00 MG TOTAL; TID; ORAL 900.00 MG Mood Altered TOTAL; ORAL Pain In Extremity 1200.00 MG TOTAL; TID; ORAL 750.00 MG TOTAL; TID; ORAL Date:10/26/99ISR Number: 3381302-7Report Type:Direct Age:80 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Cough 300 MG PO 1 DAY Initial or Prolonged Depressed Level Of 0.5MG PO 1 DAY Consciousness 5 MG PO 1 DAY Company Report # Report Source Product Role Manufacturer Route Health Lithium 300mg PS ORAL Professional Klopopin 0.5mg SS ORAL Olanzepine 5mg SS ORAL Lethargy TAB 1 Mvi SS ORAL DAY Medication Error Speech Disorder Date:10/26/99ISR Number: 3381322-2Report Type:Direct Age:49 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2 C QAM AND PT Abnormal Behaviour Agitation Company Report # Report Source Product Role Manufacturer Lithium 300mg Caps (Roxane) PS Roxane Albuterol Amlodipine Carbamazepine Haloperidol Imipramine Ipratropium C C C C C C Blood Creatinine HS AND 1C AT Increased NOON Blood Thyroid Stimulating Hormone Increased Confusional State Delusion Depression Drug Level Above Therapeutic Mental Impairment Nocturia Pneumonia Polyuria Tremor Water Intoxication 22-Aug-2005 Page: 157 10:48 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/26/99ISR Number: 3381358-1Report Type:Direct Age:57 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG,600 Initial or Prolonged AM,PM ORAL PT Company Report # Report Source Blood Creatine Product Role Manufacturer Route Lithium 300mg PS ORAL Thioridazine 100mg SS ORAL Lorazepam Potassium Atenolol C C C Phosphokinase Increased Depressed Level Of 100MG BID Consciousness ORAL Hyponatraemia Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Schizophrenia Date:11/01/99ISR Number: 3387512-7Report Type:Expedited (15-DaCompany Report #JRFBEL1999001735 Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Death Hospitalization Initial or Prolonged 28, 1 IN 1 Required TIME (S), Intervention to ORAL Prevent Permanent ORAL Impairment/Damage ORAL PT Report Source Product Role Manufacturer Route Anxiety Blood Ph Increased Cardiac Arrest Literature Health Professional Risperidone (Unspecified) (Risperidone) PS ORAL Disorientation Aspirin SS ORAL Drug Level Above Lithium (Lithium) SS ORAL Completed Suicide Confusional State Therapeutic Dyspnoea Hyperhidrosis Intentional Misuse Nausea Pco2 Decreased Respiratory Rate Increased Vomiting Date:11/02/99ISR Number: 3388562-7Report Type:Expedited (15-DaCompany Report #HQ3358225OCT1999 Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1350 MG (AS PT Report Source Product Role Manufacturer Route Drug Level Above Therapeutic Health Professional Effexor (Venlafaxine Hydrochloride) PS ORAL Nephrogenic Diabetes Other Amlodipine (Amlodipine) SS ORAL Cerivastatin (Ceriastatin) SS Lithium (Lithium) SS ORAL Quinine (Quinine() SS ORAL Temazepam SS OVERDOSE) Insipidus ORAL ONCE Overdose Polyuria 60MG (AS OVERDOSE) ORAL ONCE 600MG (AS OVERDOSE) ORAL ONCE 3600MG (AS OVERDOSE) ORAL ONCE 1.8MG (AS OVERSODE) ORAL ONCE 120MG (AS OVERDOSE) 22-Aug-2005 Page: 158 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL ONCE Date:11/02/99ISR Number: 3388671-2Report Type:Expedited (15-DaCompany Report #LBID002980017 Age:33 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE PT Report Source Product Role Abdominal Distension Alopecia Consumer Lithobid Tablets 300 Mg PS Inderal Synthroid Levoxyl Calan Hctz Lipitor Neurontin Tegretol Depakote Prozac C C C C C C C C C C Amnesia Anxiety Blood Cholesterol Increased Condition Aggravated Confusional State Dehydration Dry Mouth Headache Hypertension Hypoaesthesia Insomnia Mania Neurotoxicity Paraesthesia Pollakiuria Sedation Temperature Intolerance Manufacturer Route ORAL Date:11/04/99ISR Number: 3389210-2Report Type:Expedited (15-DaCompany Report #1999028110-1 Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Coordination Abnormal Drug Level Above Health Professional Eskalith Smithkline Beecham PS Smithkline Beecham ORAL Therapeutic Eskalith SS Smithkline Beecham ORAL Drug Toxicity Dysarthria Tremor Celebrex Carbamazepine Olanzapine Levothyroxine C C C C ORAL ORAL Date:11/04/99ISR Number: 3389304-1Report Type:Direct Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 300MG, TID, Hospitalization ORAL Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Confusional State Health Lithium PS Tremor Professional Captopril Warfarin (Coumadin) Vitamin E Docusate Sodium C C C C Date:11/05/99ISR Number: 3389358-2Report Type:Direct Age:67 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 159 10:48 AM Company Report # PT Drug Level Above Therapeutic Mental Impairment Company Report # Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Failure Acute Report Source Dose Product Role Lithium 300mg PS Dyazide Accupril Lipitor Kcl Coumadin Levoxyl Lithium Ritalin Risperidal Xanax Darvocet Naprosyn C C C C C C C C C C C C Manufacturer Route Duration ORAL 300MG PO BID Date:11/09/99ISR Number: 3391332-7Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 100MG DAILY Hospitalization 300MG 3XDAILY Initial or Prolonged Disability PT Company Report # Report Source Product Role Abnormal Behaviour Elavil PS Decreased Activity Lithium SS Manufacturer Route Loss Of Consciousness Psychotic Disorder Date:11/09/99ISR Number: 3391857-4Report Type:Expedited (15-DaCompany Report #1999010856-1 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Asthenia Cognitive Disorder Consumer Eskalith Smithkline Beecham PS Smithkline Beecham ORAL Zestril (Lisinopril) C Dizziness Dyspnoea Nervous System Disorder Personality Change Vomiting Date:11/10/99ISR Number: 3392793-XReport Type:Direct Age:48 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG PO TID Initial or Prolonged 1500 TID PT Company Report # Report Source Product Role Blood Pressure Diastolic Lithium 300mg PS Increased Valproic Acid SS Drug Toxicity Hostility Lethargy Mental Impairment Sedation Urinary Incontinence Date:11/10/99ISR Number: 3392813-2Report Type:Direct Age:47 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization 22-Aug-2005 Page: 160 10:48 AM Company Report # Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent Dose Duration Impairment/Damage 600MG BID PO PT Report Source Product Role Cyanosis Health Lithium Carbonate PS Drug Level Above Therapeutic Drug Toxicity Dyspnoea Hypotension Lethargy Pallor Pyrexia Tachycardia Tremor Professional Manufacturer Route ORAL Date:11/10/99ISR Number: 3394249-7Report Type:Expedited (15-DaCompany Report #HQ1758108OCT1999 Age:75 YR Gender:Male I/FU:F Outcome Dose Disability PT Report Source Product Role Manufacturer Route Drug Interaction Hypertensive Crisis Health Professional Effexor (Venlafaxine Hydrochloride) PS ORAL Aurorix (Moclobemide) SS ORAL Lithium (Lithium) SS ORAL Duration ORAL Medication Error Peripheral Ischaemia ORAL ORAL Date:11/16/99ISR Number: 3399066-XReport Type:Expedited (15-DaCompany Report #7399440 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 4.000 GM PO Initial or Prolonged QD PT Report Source Product Role Manufacturer Route Neuroleptic Malignant Health Abbott- Depakote PS Abbott ORAL Syndrome Professional Lithium SS Pyrexia PO ORAL Date:11/16/99ISR Number: 3399112-3Report Type:Expedited (15-DaCompany Report #9947310 Age: Gender:Male I/FU:I Outcome Dose Duration Congenital Anomaly PT Report Source Product Role Benign Congenital Hypotonia Cerebral Palsy Complications Of Maternal Exposure To Therapeutic Drugs Foreign Consumer Lithane Tablets PS Manufacturer Route ORAL Date:11/17/99ISR Number: 3399514-5Report Type:Expedited (15-DaCompany Report #LBID00299001671 Age:45 YR Gender:Male I/FU:I Outcome Dose Duration Other 300 MG BID PO PT Report Source Product Role Cataract Consumer Lithobid PS Retinal Detachment 22-Aug-2005 Page: 161 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/99ISR Number: 3404807-9Report Type:Expedited (15-DaCompany Report #PRIUSA1999006543 Age:31 YR Gender:Female I/FU:F Outcome Dose Duration Death Hospitalization ORAL Initial or Prolonged ORAL Required Intervention to ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Anuria Blood Creatine Increased Literature Health Haldol (Unspecified) (Haloperidol) PS ORAL Blood Urea Increased Professional Lithium (Lithium) SS ORAL Body Temperature Increased Prozac (Fluoxetine Hydrochloride) SS ORAL Coma Completed Suicide Convulsion Cogentin (Benzatropine Mesilate) SS ORAL Route ORAL Drug Level Above Therapeutic Electroencephalogram Abnormal Haemodialysis Hypotension Nervous System Disorder Date:11/22/99ISR Number: 3404822-5Report Type:Expedited (15-DaCompany Report #LITH00299001702 Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600/400 MG Initial or Prolonged DAILY PO 2 PT Report Source Product Role Blood Thyroid Stimulating Foreign Lithium Carbonate PS Hormone Increased Literature Bradycardia Health Cardiac Pacemaker Insertion Hypothyroidism Sick Sinus Syndrome Sinus Arrest Sinus Bradycardia Syncope Thyroxine Decreased Ventricular Extrasystoles Professional Other YR Manufacturer Route ORAL Date:11/23/99ISR Number: 3405373-4Report Type:Direct Age:51 YR Gender:Male I/FU:I Outcome Dose PT Company Report # Report Source Product Role Manufacturer Route Drug Level Above Lithium 300mg Roxane PS Roxane ORAL Therapeutic Lethargy Celebrex 200mg Searle SS Searle ORAL Duration 600MG BID PO 200MG BID PO Date:11/23/99ISR Number: 3406203-7Report Type:Expedited (15-DaCompany Report #1999026279-1 Age:55 YR Gender:Male I/FU:F Outcome Dose Disability PT Report Source Product Role Manufacturer Route Metastasis Oesophageal Consumer Health Eskalith Smithkline Beecham PS Smithkline Beecham ORAL Adenocarcinoma Stage Iv Professional Duration 1.0 DAILY ORAL 22-Aug-2005 Page: 162 30 YR 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/99ISR Number: 3406707-7Report Type:Periodic Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 275 MG, ORAL Initial or Prolonged Required 1 G, ORAL Intervention to 300 MG, THREE Prevent Permanent TIMES A DAY, Impairment/Damage ORAL Company Report #USA/98/02927/LEX PT Report Source Product Role Delirium Health Clozaril (Clozapine) PS ORAL Drug Interaction Hyperglycaemia Professional Depakote (Valproate Semisodium) SS ORAL Lithium SS ORAL Muscular Weakness Manufacturer Route Pyrexia Salivary Hypersecretion Urinary Tract Infection Date:11/23/99ISR Number: 3406946-5Report Type:Periodic Age:26 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 450 MG, ORAL Required 900 MG Intervention to Prevent Permanent Impairment/Damage Company Report #USA/99/02002/LEX PT Report Source Product Role Convulsion Health Clozaril (Clozapine) PS Fall Professional Lithium SS Leukocytosis Sedation Tachycardia Tremor Risperdal (Risperidone) Effexor (Venlafaxine Hydrochloride) Lithobid (Lithium Carbonate) Depakene (Valproate Sodium) Manufacturer Route ORAL C C C C Date:11/24/99ISR Number: 3410004-3Report Type:Expedited (15-DaCompany Report #LBID00299001810 Age: Gender:Male I/FU:I Outcome Dose Duration Other 1200 MG DAILY PT Report Source Product Role Mycosis Fungoides Health Lithobid PS Manufacturer Route ORAL Professional PO Adderal Ativan Effexor Date:11/29/99ISR Number: 3409396-0Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose PT C C C Company Report # Report Source Product Role Blood Amylase Increased Clozaril PS Lactose Intolerance Lithium SS Manufacturer Route Manufacturer Route Duration 200MG BID 300MG QD 1 YR Lipase Increased Pancreatitis Date:11/29/99ISR Number: 3409498-9Report Type:Direct Age:63 YR Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 5MG PO QD PT Report Source Product Role Diarrhoea Disorientation Health Professional Lisinopril 5mg Unknown PS ORAL Lithium 300mg Unknown SS ORAL Drug Interaction Gait Disturbance 600MG PO BID Speech Disorder 22-Aug-2005 Page: 163 10:48 AM Company Report # FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/99ISR Number: 3409542-9Report Type:Direct Age:75 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG BID Initial or Prolonged PT Company Report # Report Source Product Role Agitation Lithium PS Akathisia Confusional State Speech Disorder Tremor Depakote C Manufacturer Route Date:11/29/99ISR Number: 3409862-8Report Type:Expedited (15-DaCompany Report #9912255 Age:57 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 500.000 MG PO Initial or Prolonged BID PT Report Source Product Role Manufacturer Route Hyponatraemia Foreign Abbott- Depakote PS Abbott ORAL Nephrogenic Diabetes Health Insipidus Pollakiuria Polydipsia Polyuria Professional Lithium SS Manufacturer Route Date:11/30/99ISR Number: 3409619-8Report Type:Direct Age:57 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 300MG PO TID Hospitalization Initial or Prolonged PT Company Report # Report Source Nephritis Product Role Lithium PS ORAL Nephrogenic Diabetes Insipidus Date:12/03/99ISR Number: 3413543-4Report Type:Expedited (15-DaCompany Report #210600 Age:59 YR Gender:Male I/FU:F Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization Initial or Prolonged Abdominal Pain Bipolar Disorder Chest Discomfort Circulatory Collapse Consumer Health Professional Lariam Tablets (Mefloquine Hydrochloride) 250 Mg PS ORAL Lithium (Lithium Nos) SS ORAL Lorazepam (Lorazepam) Atenolol (Atenolol) C C 250 MG 1 PER Coordination Abnormal WEEK ORAL Diarrhoea Disorientation 300 MG DAILY Drug Hypersensitivity ORAL Dry Skin Flatulence Hypertension Insomnia Leukocytosis Mania Palpitations Pruritus Pyrexia Tremor Urticaria Vomiting Projectile 22-Aug-2005 Page: 164 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/99ISR Number: 3417763-4Report Type:Expedited (15-DaCompany Report #9912255 Age:57 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 500.000 MG PO Initial or Prolonged BID PT Report Source Product Role Drug Toxicity Foreign Abbott - Depakote PS Hyponatraemia Health Nephrogenic Diabetes Insipidus Pollakiuria Polydipsia Polyuria Professional Lithium SS Manufacturer Route ORAL Date:12/09/99ISR Number: 3418170-0Report Type:Expedited (15-DaCompany Report #1999004849NL Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2 MG, QD, PT Report Source Product Role Dizziness Electrocardiogram Health Professional Detrusitol (Tolterodine) Tablet PS Abnormal Other Electrocardiogram T Wave Amplitude Decreased Theolin-Slow Release (Theophylline) SS Nausea Zestril (Lisinopril) SS Syncope Ventricular Tachycardia Clomipramine (Clomipramine) SS Aspirine (Acetylsalicylic Acid) SS Priadel (Lithium Carbonate) SS Acetylcysteine (Acetylcysteine) SS ORAL 300 MG, BID 8 DAY 10 MG, QD 8 DAY 25 MG, TID 80 MG, QD 400 MG, BID 600, QD 8 8 8 8 DAY DAY DAY DAY Ventoline Manufacturer Route ORAL (Salbutamol) 8 SS DAY Date:12/10/99ISR Number: 3417871-8Report Type:Direct Age:9 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 450MG AM Hospitalization 300MG HS ORAL Initial or Prolonged Company Report # PT Report Source Product Role Diabetes Insipidus Health Lithium 300mg PS Valproic Acid Olanzapine C C Professional Date:12/10/99ISR Number: 3418557-6Report Type:Expedited (15-DaCompany Report #PRIUSA1999006655 Age:57 YR Gender:Female I/FU:F Outcome Death Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 165 10:48 AM PT Abdominal Distension Blood Pressure Increased Cardiac Arrest Coma Completed Suicide Convulsion Dialysis Drug Level Above Therapeutic Electrocardiogram St Segment Elevation Electrocardiogram T Wave Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Peaked Extrapyramidal Disorder Hypoventilation Ileus Paralytic Report Source Product Role Injury Overdose Literature Health Haldol (Unspecified) (Haloperidol) PS ORAL Sinus Tachycardia Tachypnoea Professional Eskalith (Lithium Carbonate) SS ORAL Therapeutic Agent Toxicity Tremor Lopressor (Metoprolol Tartrate) SS ORAL Ventricular Tachycardia Kaolin (Kaolin) SS ORAL Klonopin (Clonazepam) SS ORAL Theochron (Theophylline) SS ORAL Synthroid (Levothyroxine Sodium) SS ORAL Sodium Fluoride (Sodium Fluoride) SS ORAL Aspirin (Acetylsalicylic Acid) SS ORAL Tylenol (Paracetamol) SS ORAL Naprosyn (Naproxen) SS ORAL Cogentin (Benzatropine Mesilate) SS ORAL Nitroglycerin (Glyceril Trinitrate) SS ORAL Manufacturer Route Duration ORAL 300 MG, ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL Vitamin B Complex (B-Komplex "Leciva") SS ORAL ORAL Date:12/10/99ISR Number: 3418591-6Report Type:Expedited (15-DaCompany Report #PRIUSA1999006689 Age:70 YR Gender:Female I/FU:F Outcome Dose Duration Death Hospitalization ORAL Initial or Prolonged Required ORAL Intervention to ORAL Prevent Permanent Impairment/Damage ORAL PT Report Source Product Role Blood Creatinine Increased Literature Health Haldol(Unspecified) (Haloperidol) PS ORAL Blood Glucose Increased Blood Potassium Decreased Professional Synthroid(Levothyrox ine Sodium) SS ORAL Bradycardia Prinivil(Lisinopril) SS ORAL Cardiac Arrest Cardio-Respiratory Arrest Eskalith(Lithium Carbonate) SS ORAL Completed Suicide Dyazide(Dyazide) SS ORAL ORAL Depressed Level Of Consciousness Hypotension Intentional Misuse Lethargy Medication Residue White Blood Cell Count Increased 22-Aug-2005 Page: 166 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/99ISR Number: 3424965-XReport Type:Direct Age:59.5 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization DAILY Initial or Prolonged Company Report # PT Report Source Product Role Blood Pressure Increased Consumer Lithium PS Trazodone Effexor Klonopin SS SS SS Breast Pain Cognitive Disorder Confusional State Diarrhoea Headache Hearing Impaired Hostility Hypertonia Memory Impairment Personality Change Sedation Suicidal Ideation Manufacturer Route Manufacturer Route Date:12/14/99ISR Number: 3426113-9Report Type:Expedited (15-DaCompany Report #1999032202-2 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization ORAL 9 YR Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Aggression Consumer Lithium PS Thorazine C Cardiomegaly Hypertension Liver Function Test Abnormal Renal Disorder ORAL Date:12/15/99ISR Number: 3422723-3Report Type:Expedited (15-DaCompany Report #JACGER1999000854 Age: Gender:Male I/FU:I Outcome Dose PT Report Source Product Role Bradycardia Foetal Caesarean Section Foreign Health Haldol (2 Mg/Ml Drops) (Haloperidol) PS Complications Of Maternal Professional Manufacturer Route Duration DROPS, DAILY, ORAL/ UTERINE ORAL Exposure To Therapeutic Drugs Litium (Lithium Carbonate) SS ORAL ORAL/UTERINE Date:12/16/99ISR Number: 3423548-5Report Type:Expedited (15-DaCompany Report #1999004849NL Age:72 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 2 MG, QD, PT Report Source Product Role Manufacturer Route Cardiomyopathy Circulatory Collapse Health Professional Detrusitol(Tolterodi ne) Tablet PS ORAL Theolin - Slow Release SS ORAL Malaise Nausea Clomipramine (Clomipramine) SS Pulse Pressure Decreased Syncope Priadel(Lithium Carbonate) SS Tremor Ventricular Fibrillation Ventoline (Salbutamol) SS Ventricular Tachycardia Zestril Aspirine Acetylcysteine C C C Dizziness ORAL Electrocardiogram T Wave Amplitude Decreased 300 MG, QD, Hypokalaemia ORAL 8 25 MG, TID 400 MG, BID 8 8 8 DAY DAY DAY DAY 22-Aug-2005 Page: 167 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/99ISR Number: 3426827-0Report Type:Expedited (15-DaCompany Report #1999031983-1 Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Haematemesis Product Lithium Smithkline Beecham Cloazaril (Clozapine) Role Manufacturer PS Smithkline Beecham Route C Date:12/17/99ISR Number: 3424972-7Report Type:Expedited (15-DaCompany Report #9951716 Age: Gender: I/FU:I Outcome Dose Duration Congenital Anomaly UNKNOWN; ORAL PT Report Source Product Role Cardiac Septal Defect Foreign Lithane Tablets PS Coarctation Of The Aorta Complications Of Maternal Exposure To Therapeutic Drugs Heart Disease Congenital Health Professional Date:12/17/99ISR Number: 3425533-6Report Type:Periodic Age:11 YR Gender:Male I/FU:I Outcome Dose Other Manufacturer Route ORAL Company Report #9903582 PT Report Source Product Role Manufacturer Route Drug Interaction Sedation Health Professional Zithromax Pediatric Oral Suspension PS ORAL Lithobid SS ORAL Wellbutrin C Duration ORAL 900.00 MG TOTAL; TID; ORAL Date:12/20/99ISR Number: 3426057-2Report Type:Direct Age:36 YR Gender:Female I/FU:I Company Report # Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Aggression Convulsion Drug Level Above Therapeutic Restlessness Product Role Lithium Anafranil Depakote Chromagen Kava PS C C C C Manufacturer Route Manufacturer Route Date:12/20/99ISR Number: 3426583-6Report Type:Expedited (15-DaCompany Report #10184109 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 Initial or Prolonged MILLIGRAM, PT Report Source Product Role Amnesia Foreign Avapro(Irbesartan) PS Drug Toxicity Study Enalapril(Enalapril Maleate) SS Lithium(Lithium Salts) Diabeta(Glyburide) SS C Health ORAL Professional 40 MILLIGRAM 22-Aug-2005 Page: 168 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/99ISR Number: 3430073-4Report Type:Expedited (15-DaCompany Report #990809-LX254 Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Required QHS PO Intervention to 900.000 MG QD Prevent Permanent PO Impairment/Damage 150.000 MG PT Report Source Product Role Manufacturer Route Dysphonia Health Ambien PS ORAL Stereotypy Professional Lithium Carbonate SS ORAL Wellbutrin SS ORAL Other Cns Drugs Celecoxib C C Company Representative TID PO Date:12/28/99ISR Number: 3431432-6Report Type:Direct Age:59.5 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization DAILY Initial or Prolonged DAILY PT Company Report # Report Source Product Role Blood Pressure Increased Lithium PS Breast Pain Trazodone SS Cognitive Disorder Effexor SS Confusional State Klonopin SS DAILY DAILY Diarrhoea Headache Hearing Impaired Hostility Hypertonia Memory Impairment Personality Change Sedation Suicidal Ideation Date:12/28/99ISR Number: 3432380-8Report Type:Direct Age:51 YR Gender:Male I/FU:I Company Report # Manufacturer Route Outcome Dose Duration Hospitalization 300MG TID Initial or Prolonged 25MG/D PT Report Source Product Role Dyspnoea Health Lithium 300mg PS Nephrotic Syndrome Professional Ptu SS Furosemide Kcl Metalazone Ipatropium Lisinopril Cetrizine C C C C C C Oedema Oedema Peripheral Oliguria Proteinuria Date:12/29/99ISR Number: 3433484-6Report Type:Direct Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300MG PO TID PT Drug Toxicity Lethargy 10:48 AM Route Manufacturer Route Company Report # Report Source Product Role Lithium Carbonate Interaction? PS Lisinopril 10mg SS Aspirin Atenocol Benztropine Furosemide Lisinopril Lithium Nifedipine Thiothixine C C C C C C C C 10MG QD 22-Aug-2005 Page: 169 Manufacturer ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/99ISR Number: 3435343-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999002168 Age:70 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 3MG 3 IN 1 PT Report Source Product Role Blepharospasm Parkinsonism Foreign Literature Haldol (Unspecified) (Haloperidol) PS Tardive Dyskinesia Health Tremor Professional Lithium (Lithium) SS Manufacturer Route Manufacturer Route Manufacturer Route DAY (S) Date:01/03/00ISR Number: 3435492-8Report Type:Direct Age:23 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization TAKEN PRIOR Initial or Prolonged TO ADMISSION PT Company Report # Report Source Intentional Misuse Date:01/05/00ISR Number: 3437688-8Report Type:Direct Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization SEE IMAGE Initial or Prolonged SEE IMAGE Product Role Lithium PS Clonidine Seroqual Trimethobenzamide Lorazepam Trazodone Clonidine Provera Valtrex C C C C C C C C Company Report # PT Report Source Product Role Neurotoxicity Health Seroquel PS Professional Lithobid SS Depakote Ativan Hytrin Maxzide C C C C Vioxx Prozac Prilosec Ogen Albuterol Inh Date:01/07/00ISR Number: 3440011-6Report Type:Direct Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 20MG BID Initial or Prolonged 600MG BID Company Report # PT Report Source Product Role Blood Creatinine Health Furosemide PS Increased Professional Lithium SS Blood Urea Increased Confusional State Metabolic Acidosis Renal Failure Acute Tremor Date:01/10/00ISR Number: 3441688-1Report Type:Expedited (15-DaCompany Report #10222974 Age:59 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization 22-Aug-2005 Page: 170 10:48 AM C C C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Dose PT Report Source Product Role Manufacturer Route Atrioventricular Block Foreign Captopril PS ORAL First Degree Health Blood Creatine Increased Professional Meloxicam SS ORAL Lithium (Lithium Salts) SS ORAL Duration 50 MILLIGRAM, 1 DAY, ORAL 7.5 Bradycardia MILLIGRAM, 1 Cyanosis DAY, ORAL Drug Level Above Therapeutic 900 Electrocardiogram T Wave MILLIGRAM, 1 Inversion DAY, ORAL Hypotension Pulse Absent Shock Tremor Date:01/11/00ISR Number: 3442675-XReport Type:Direct Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG Q AM & Initial or Prolonged 600 Q HS PT Abnormal Behaviour Lorazepam (Lorazepam) Mirtazapine (Mirtazapine) Temazepam (Temazepam) Xipamide (Xipamide) C C C C Company Report # Report Source Product Role Lithium PS Metgmolol Valproic Acid Terazosin Ecasa Lipitor Plavix C C C C C C Confusional State Diarrhoea Drug Toxicity Oral Intake Reduced Tremor Manufacturer Route Date:01/11/00ISR Number: 3442870-XReport Type:Expedited (15-DaCompany Report #9953096 Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Required 5.00 MG Intervention to TOTAL:DAILY:O Prevent Permanent RAL Impairment/Damage 600.00 MG PT Report Source Product Role Manufacturer Route Drug Level Above Foreign Norvasc Tablets PS ORAL Therapeutic Health Lithium SS ORAL Professional Other TOTAL:DAILY:O RAL Date:01/12/00ISR Number: 3446105-3Report Type:Expedited (15-DaCompany Report #2000000633-1 Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Required 900 Intervention to MILLIGRAMS Prevent Permanent 1.0 DAILY Impairment/Damage ORAL PT Report Source Product Role Abnormal Behaviour Health Lithium Carbonate PS Professional Ambien (Zolpidem Tartrate) Wellbutrin Celebrex (Celecoxib) Other Psychotropic Medications (Nos) 22-Aug-2005 Page: 171 10:48 AM C C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/00ISR Number: 3444273-0Report Type:Periodic Age:53 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization PO Initial or Prolonged 675.000 MG Company Report #990913-SK052 PT Report Source Product Role Manufacturer Route Drug Interaction Consumer Celebrex PS ORAL Lithium SS ORAL Calcium Alendronate Propoxyphene Acetaminophen Omeprazole Levothyroxine C C C C C C BID PO Date:01/13/00ISR Number: 3528672-4Report Type:Periodic Age:38 YR Gender:Male I/FU:I Outcome Dose Company Report #991118-SK311 PT Report Source Product Role Manufacturer Route Drug Interaction Consumer Celebrex PS Gd Searle And Co ORAL Drug Level Above Health Therapeutic Professional Lithobid SS Bupropion Clonazepam Risperidone Lamotrigine C C C C Duration 200.000 MG QD PO ORAL 900.000 MG QD PO Date:01/18/00ISR Number: 3445091-XReport Type:Expedited (15-DaCompany Report #10230852 Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization - PT Report Source Product Agitation Foreign Cefzil Tabs Role Manufacturer Route Initial or Prolonged ORAL Confusional State Health (Cefprozil) PS ORAL Drug Toxicity Professional Lithium Carbonate SS ORAL Haldol (Halopridol) Cogentin (Benztropine Mesylate) Ventolin (Albuterol) Becloforte Inhaler (Beclomethasone Dipropionate) C 600 Other MILLIGRAM, 2/1 DAY, ORAL Date:01/24/00ISR Number: 3446084-9Report Type:Direct Age: Gender:Male I/FU:I Outcome Life-Threatening Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 172 10:48 AM PT Abdominal Distension Aortic Occlusion Coagulopathy Coma Decreased Activity Diabetes Mellitus Drug Interaction Dry Mouth Embolism Foot Amputation Company Report # C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gallbladder Disorder Gangrene Hyperglycaemia Dose Report Source Product Role Zyprexa PS Skin Discolouration Lithium SS Stupor Surgery Vision Blurred Vomiting Weight Increased Vasotec Niapsan Clonazepam Paxil C C C C Manufacturer Route Manufacturer Route Duration Hyperpyrexia 2 MG ONCE Renal Impairment DAILY 300 MG 5X/DAY Date:01/24/00ISR Number: 3446426-4Report Type:Expedited (15-DaCompany Report #10184109 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization 300 Initial or Prolonged MILLIGRAM, PT Report Source Product Role Amnesia Foreign Avapro (Irbesartan) PS Memory Impairment Study Neurotoxicity Health Therapeutic Agent Toxicity Professional Other Enalapril (Enalapril Maleate) SS Lithium (Lithium Salts) Diabeta SS C ORAL ORAL 40 MILLIGRAM Date:01/24/00ISR Number: 3447243-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000000200 Age:13 YR Gender:Female I/FU:I Outcome Dose 1 MG, 2 IN 1 PT Report Source Product Role Autonomic Nervous System Imbalance Health Professional Risperdal (Tablet) (Risperidone) PS Manufacturer Route Duration ORAL Blood Creatine DAY(S) ORAL Phosphokinase Increased Seroquel (Seroquel) SS ORAL Dehydration Drug Level Above Loxitane (Loxapine Succinate) SS ORAL Therapeutic Lithium (Lithium) SS ORAL Drug Toxicity Hypertension Leukopenia Mental Impairment Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Synthroid (Levothyroxine Sodium) Depakote (Valproate Semisodium) C 600 MG, DAILY Conjunctivitis ORAL ORAL ORAL Date:01/27/00ISR Number: 3447251-0Report Type:Expedited (15-DaCompany Report #A001108 Age:76 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 173 10:48 AM PT Barium Swallow Abnormal Cough Dysphagia Dysphonia Hyporeflexia Neuroleptic Malignant Syndrome Parkinsonism C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Decreased Dose Report Source Product Role Manufacturer Route Foreign Zoloft Tablets PS ORAL Haloperidol SS ORAL Lithium SS ORAL Temazepam SS Duration 200.00 MG Literature TOTAL:ORAL 6 WK Health 6.00 MG Professional TOTAL:ORAL 6 WK ORAL 6 WK 6 WK Date:01/27/00ISR Number: 3447896-8Report Type:Expedited (15-DaCompany Report #LITH00200000388 Age:41 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization DAILY PO Initial or Prolonged 500 MG DAILY, PT Report Source Product Role Convulsion Health Lithium PS Drug Level Above Professional Clozaril SS Luvox SS Depakote Zyprexa Loxapine C C C Manufacturer Route ORAL Therapeutic DAILY, DAILY Muscle Twitching 150 MG BID, 50 MG BID Date:01/28/00ISR Number: 3446958-9Report Type:Direct Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 1T 2 XD PT Chest Pain Company Report # Report Source Product Role Propulsid PS Manufacturer Route Required 600 BID Intervention to 1T Q AM Prevent Permanent Impairment/Damage Coordination Abnormal Lithium SS Dyspnoea Prozac SS Fall Heart Rate Irregular Palpitations Tremor Date:01/28/00ISR Number: 3449161-1Report Type:Expedited (15-DaCompany Report #2000001172-1 Age:40 YR Gender:Male I/FU:I Outcome Dose Other 22-Aug-2005 Page: 174 PT Report Source Product Role Manufacturer Biopsy Kidney Abnormal Blood Creatinine Increased Blood Urea Increased Glomerulonephritis Hypertension Hypomania Proteinuria Renal Failure Renal Impairment Renal Interstitial Fibrosis Renal Tubular Atrophy Literature Health Professional Lithium Smithkline Beecham PS Smithkline Beecham Duration 10:48 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/00ISR Number: 3447860-9Report Type:Direct Age:59 YR Gender:Male I/FU:I Outcome Dose Other 300 MG BID PT Company Report # Report Source Product Role Lithium PS Manufacturer Route Route Duration Condition Aggravated Decreased Appetite Drug Toxicity Dysarthria Muscle Spasms Tremor Date:01/31/00ISR Number: 3452129-2Report Type:Expedited (15-DaCompany Report #2000001826-1 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 PT Report Source Drug Interaction Mania Product Role Manufacturer Lithium Smithkline Beecham PS Smithkline Beecham Erythromycin Prednisolone C C MILLIGRAMS DAILY Date:01/31/00ISR Number: 3452140-1Report Type:Expedited (15-DaCompany Report #2000001713-1 Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 675 PT Report Source Product Role Manufacturer Route Asthenia Drug Interaction Health Professional Lithium Smithkline Beecham PS Smithkline Beecham ORAL Drug Level Above MILLIGRAMS Therapeutic 2.0 DAILY Drug Toxicity ORAL Nausea Lithium Smithkline Tremor Beecham SS Calcium Alendronate Propoxyphene Omeprazole Levothyroxine Celebrex (Celecoxib) C C C C C C Smithkline Beecham ORAL Manufacturer Route 675 MG 2.0 Vomiting DAILY ORAL Date:02/01/00ISR Number: 3449652-3Report Type:Expedited (15-DaCompany Report #JACGER2000000104 Age:30 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Cardiomegaly Foreign Health Haldol (Tablet) (Haloperidol) PS ORAL Neurocil (Levomepromazine Maleate) SS ORAL Hypnorex (Lithium Carbonate) SS ORAL Diazepam (Diazepam) SS ORAL Duration MG, DAILY, Professional ORAL MG, DAILY, ORAL (SEE IMAGE) MG, DAILY, ORAL MG, DAILY, ORAL 22-Aug-2005 Page: 175 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/00ISR Number: 3449658-4Report Type:Expedited (15-DaCompany Report #JACGBR2000000028 Age:43 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Depressed Level Of Consciousness Foreign Health Haldol (Unspecified) (Haloperidol) PS ORAL Faecal Incontinence Professional Lithium Carbonate (Lithium Carbonate) SS ORAL Duration MG, DAILY, ORAL Hypotonia Neurotoxicity MG, DAILY, Tremor ORAL Carbamazepine (Carbamazepine) Propantheline (Propantheline) Procyclidine (Procyclidine) Entera (Other Combinations Of Nutrients) Date:02/02/00ISR Number: 3449879-0Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 1000 MG PO QD Initial or Prolonged PT Outcome Dose Duration Hospitalization 300MG PO BID Initial or Prolonged Other PT Bradycardia Lethargy Mental Impairment C C C Company Report # Report Source Bradycardia Date:02/02/00ISR Number: 3450098-2Report Type:Direct Age: Gender:Male I/FU:I C Product Role Lithium PS Manufacturer Route ORAL Company Report # Report Source Product Role Lithium Carbonate PS Manufacturer Route ORAL Date:02/02/00ISR Number: 3450163-XReport Type:Direct Age:67 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600MG PO TID Initial or Prolonged PT Product Role Drug Level Above Lithium PS Therapeutic Mental Impairment Levothyroxine Benztropin Atenolol Haloperidol Acetaminophen C C C C C Date:02/02/00ISR Number: 3450201-4Report Type:Direct Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 176 10:48 AM Company Report # PT Blood Creatinine Increased Blood Pressure Diastolic Decreased Blood Urea Increased Bradycardia Drug Level Above Therapeutic Report Source Company Report # Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Toxicity Tremor Dose Report Source Product Role Health Lithium 600mg PS Professional Diclofenac Etoh SS SS Manufacturer Route Manufacturer Route Duration BID Date:02/02/00ISR Number: 3450259-2Report Type:Direct Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600 MG BID PO Initial or Prolonged 6 YR. 6 YR PT Company Report # Report Source Abdominal Pain Product Role Lithium Carbonate PS ORAL Diarrhoea Dysarthria Headache Lethargy Vision Blurred Date:02/02/00ISR Number: 3450537-7Report Type:Expedited (15-DaCompany Report #18588-021 Age:32 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Communication Disorder Distractibility Drug Interaction Mental Status Changes Health Professional Lithium Carbonate Tablets Usp, 300mg Roxane Laboratories, Inc. PS Roxane Laboratories, Inc. ORAL 450MG QAM & 600MG QPM, PO Seroquel (Quetiapine Fumarate) 200mg Zeneca Pharmaceuticals, Inc. SS Zeneca Pharmaceuticals, Inc. ORAL Manufacturer Route 400MG QHS, PO Gabitril Ambien (Zolpidem Tartrate) Mysoline (Primidone) Prometrium(Progester one) Vitamin B6 Calcium Supplements C C C C C C Date:02/02/00ISR Number: 3450553-5Report Type:Expedited (15-DaCompany Report #FLUV00300000423 Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 50 MG DAILY Initial or Prolonged PO PT Report Source Product Role Agitation Foreign Fluvoxamine PS Akathisia Literature Drug Level Above Therapeutic Other Flupenthixol Decanoate SS Poisoning Deliberate Haloperidol SS ORAL Restless Legs Syndrome Lithium SS ORAL Trihexyphenidyl SS ORAL ORAL DAILY 5 MG DAILY PO 400 MG BID Restlessness PO; 400 MG Suicidal Ideation DAILY Suicide Attempt 2 MG PO 22-Aug-2005 Page: 177 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/00ISR Number: 3451030-8Report Type:Expedited (15-DaCompany Report #WAES 99128377 Age:62 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 10 MG PO 48 DAY Initial or Prolonged 750 MG PO 67 DAY PT Report Source Product Role Drug Level Above Therapeutic Foreign Health Tab Singulair (Montelukast Sodium) PS ORAL Drug Toxicity Professional Tab Lithiumco3 SS ORAL Albuterol Fluticasone Propionate Furosemide Potassium Chloride Sulfasalazine Trimipramine C Renal Impairment Manufacturer Route C C C C C Date:02/04/00ISR Number: 3452449-1Report Type:Expedited (15-DaCompany Report #10230852 Age:53 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Agitation Confusional State Foreign Health Cefzil Tabs (Cefprozil) PS ORAL Drug Level Above Professional Lithium Carbonate SS ORAL Haldol (Haloperidol) Cogentin (Benztropine Mesylate) Ventolin (Albuterol) Becloforte Inhaler (Beclomethasone Dipropionate) C 600 Therapeutic MILLIGRAM, Drug Toxicity 2/1 DAY ORAL Date:02/07/00ISR Number: 3453259-1Report Type:Direct Age:49 YR Gender:Male I/FU:I Company Report # C C C Manufacturer Route Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Diarrhoea Drug Level Above Therapeutic Dysarthria Vomiting Health Professional Lithium 300mg Q 8hrs PS Manufacturer Route Manufacturer Route Date:02/07/00ISR Number: 3453469-3Report Type:Expedited (15-DaCompany Report #USA/00/00235/SIM03 Age:58 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 200 MG TWICE PT Report Source Product Role Confusional State Drug Interaction Health Professional Sandimmune Neoral (Cyclosporine, Usp) PS Lithium SS Drug Level Above A DAY ORAL Therapeutic Drug Toxicity Hypertension 22-Aug-2005 Page: 178 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/00ISR Number: 3454161-1Report Type:Expedited (15-DaCompany Report #LITH00200000551 Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 400 MG BID Initial or Prolonged PO, 400 MG PT Report Source Product Role Manufacturer Route Agitation Foreign Lithium PS ORAL Akathisia Literature Condition Aggravated Other Fluvoxamine SS ORAL Drug Level Above Navane SS Therapeutic Haloperidol SS ORAL Poisoning Deliberate Trihexyphenidyl SS ORAL DAILY UNK Depressed Mood 50 MG DAILY Drug Interaction PO DAILY 5 MG DAILY PO 2 MG PO Restlessness Suicidal Ideation Tremor Date:02/08/00ISR Number: 3454366-XReport Type:Direct Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Required 300 MG, Intervention to QNOON, PO Prevent Permanent 600 MG, BID, Impairment/Damage PO PT Lethargy Company Report # Report Source Product Role Manufacturer Route Lithium Cap, Oral PS ORAL Lithium Cap, Oral SS ORAL Nausea Vomiting Date:02/10/00ISR Number: 3456304-2Report Type:Expedited (15-DaCompany Report #00F--10078 Age:77 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Coma Dehydration Drug Interaction Foreign Health Professional Anafranil Tablet (Clomipramine Hydrochloride) PS ORAL Pyrexia Rhabdomyolysis Other Modopar Capsule (Madopar) SS ORAL Teralithe Slow Release Tablet (Lithium Carbonate) SS ORAL Deprenyl Tablet (Selegiline) SS ORAL Lysanxia Tablet C DAILY, ORAL 3 DF, DAILY, Shock ORAL 9 MON 800 MG, DAILY, ORAL 10 MG, DAILY, ORAL Date:02/11/00ISR Number: 3457131-2Report Type:Expedited (15-DaCompany Report #A003235 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 30.00 MG Initial or Prolonged TOTAL:DAILY:O PT Report Source Product Role Drug Interaction Foreign Sterane Tablets PS Lower Respiratory Tract Health Infection Professional Mania Other Lithium SS RAL 600.00 MG TOTAL:BID 22-Aug-2005 Page: 179 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/00ISR Number: 3457289-5Report Type:Expedited (15-DaCompany Report #A003576 Age: Gender:Male I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent ORAL Impairment/Damage PT Report Source Product Role Drug Interaction Electrocardiogram Qt Prolonged Health Professional Procardia Xl Extended Release Tablets PS Lithium Nardil Mellaril Yohimbine SS SS SS C Date:02/14/00ISR Number: 3457311-6Report Type:Direct Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Confusional State 900MG BID PO 2 MON Initial or Prolonged Diarrhoea Drug Toxicity Dysarthria Lethargy Tremor Report Source Product Role Lithium 900mg PS Vasotec Valium Prilosec Prozac Norvasc C C C C C ORAL Manufacturer Route ORAL Company Report # PT Report Source Product Role Coma Health Zyprexa 15 Mg/Day PS Muscle Rigidity Professional Lithobid 600 Mg Bid SS Pyrexia Neurontil 600mg Tid SS Tremor Symmetrel 900mg/Day SS Duration 600 MG BID 600MG TID 900MG/DAY Route Company Report # Date:02/14/00ISR Number: 3457402-XReport Type:Direct Age:53 YR Gender:Male I/FU:I Outcome Dose Death 15MG/DAY Manufacturer Manufacturer Route Date:02/14/00ISR Number: 3457548-6Report Type:Expedited (15-DaCompany Report #A003284 Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged 50.00 MG PT Report Source Product Role Manufacturer Route Agitation Foreign Lithane Tablets PS ORAL Akathisia Literature Fluvoxamine SS ORAL Condition Aggravated Health Depressed Mood Professional Haloperidol SS ORAL Chlorpromazine Thioridazine Mianscrin Amitriptyline C C C C TOTAL: ORAL ORAL Difficulty In Walking Emotional Distress Movement Disorder Poisoning Deliberate Restlessness Suicidal Ideation Tremor Date:02/14/00ISR Number: 3459611-2Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL PT Report Source Product Role Agitation Drug Level Above Consumer Neurontin (Gabapentin) PS ORAL Lithobid (Lithium Carbonate) SS ORAL Therapeutic Feeling Drunk 600 MG Nausea (DAILY), PER ORAL 22-Aug-2005 Page: 180 10:48 AM Company Report #001-0945-990106 Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa (Olanzapine) SS ORAL Wellbutrin (Amfebutamone Hydrochloride) SS ORAL Ambien (Zolpidem Tartrate) SS ORAL Zoloft (Sertraline Hydrochloride) SS ORAL Klonopin (Clonazepam) SS ORAL Benzotropine (Benzatropine Mesilate) SS ORAL Inderal (Propranolol Hydrochloride) C PER ORAL PER ORAL PER ORAL PER ORAL PER ORAL PER ORAL Date:02/15/00ISR Number: 3458200-3Report Type:Expedited (15-DaCompany Report #1999026279-1 Age:55 YR Gender:Male I/FU:F Outcome Dose Disability PT Report Source Product Role Manufacturer Route Lymphadenopathy Metastases To Liver Consumer Health Eskalith Smithkline Beecham PS Smithkline Beecham ORAL Oesophageal Professional Role Manufacturer Route Duration 1.0 DAILY ORAL 30 YR Adenocarcinoma Date:02/16/00ISR Number: 3458750-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000000274 Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Agitation Akathisia Chemical Poisoning Condition Aggravated Foreign Literature Health Professional Haldol (Unspecified) (Haloperidol) Chlorpromazine (Cloropromazine) PS SS Depressed Mood Drug Interaction Restlessness Suicidal Ideation Suicide Attempt Tremor Thioridazine (Thioridazine) Amitriptyline (Amitriptyline) Mianserin (Mianserin) Lithium (Lithium) Flupenthixol Decanoate (Flupentixol Decanoate) SS SS SS SS SS MG, 1 IN 1 MONTH(S) Trihexyphenidyl (Trihexyphenidyl) SS Fluvoxamine (Fluvoxamine) SS ORAL 2 MG, 2 IN 1 DAY(S), ORAL MG, DAILY Date:02/17/00ISR Number: 3459422-8Report Type:Expedited (15-DaCompany Report #2000UW00488 Age:32 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 400 MG HS PO Initial or Prolonged 450 MG QD PO 22-Aug-2005 Page: 181 10:48 AM PT Report Source Product Role Manufacturer Route Drug Interaction Health Seroquel PS Zeneca ORAL Mental Impairment Professional Lithium Carbonate Tablets SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium Carbonate Tablets SS Gabitril Ambien Mysoline Prometrium Multiple Vitamins Vitamin B6 Calcium C C C C C C C ORAL 600 MG HS PO Date:02/18/00ISR Number: 3460384-8Report Type:Expedited (15-DaCompany Report #HQ0890403FEB2000 Age: Gender:Male I/FU:I Outcome Dose Other ORAL PT Report Source Product Role Cellulitis Health Effexor PS Dermatitis Oedema Professional Lithium Seroquel "Zeneca" SS SS Zeneca ORAL Manufacturer Route Manufacturer Route Duration 1 ORAL WK ORAL Pyrexia Weight Increased Date:02/22/00ISR Number: 3461233-4Report Type:Expedited (15-DaCompany Report #USA/00/00358/LEX Age:31 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 200 MG, ORAL Initial or Prolonged 600 MG PT Report Source Product Role Abdominal Pain Health Clozaril (Clozapine) PS Back Pain Professional Lithobid SS Depakote Ativan Prolixin C C C Bronchitis Dehydration Drug Level Above Therapeutic Gait Disturbance Leukocytosis Myalgia Pyrexia Renal Failure Acute Vomiting ORAL Date:02/22/00ISR Number: 3462027-6Report Type:Expedited (15-DaCompany Report #JACFRA2000000125 Age:35 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Leukocytosis Pyrexia Foreign Health Professional Haldol (20 Mg Tablet) (Haloperidol) PS ORAL Tercian (Cyamemazine0 SS ORAL Teralithe Sodium (Lithium Carbonate) SS ORAL Clopixol (Zuclopenthixol Decanoate) SS 20 MG, 3 IN 1 DAY (S), ORAL ORAL MG, DAILY, ORAL INTRAMUSCULAR 22-Aug-2005 Page: 182 IM 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3461294-2Report Type:Direct Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300MG TID/ PT Company Report # Report Source Confusional State Delirium Product Role Lithium Carbonate 300mg Cap PS Alprazolam Furosemide Glyburide Potassium Chloride Lisinopril C C C C C Manufacturer Route ORAL Renal Failure Acute ORAL Urinary Retention Date:02/23/00ISR Number: 3461386-8Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1 BID Initial or Prolonged Other 2 BID Company Report # PT Report Source Product Role Drug Level Above Health Fosinopril 10 Mg PS Therapeutic Professional Licos 300mg Lithium Carbonate SS Date:02/23/00ISR Number: 3463280-5Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Other 150.00 MG Manufacturer Route Manufacturer Route Company Report #9925224 PT Report Source Product Role Depression Consumer Zoloft Tablets PS ORAL Lithium Remeron Buspar SS SS SS ORAL Duration Drug Ineffective TOTAL:DAILY:O RAL 10.00 MG TOTAL:DAILY:O RAL Prempro Date:02/23/00ISR Number: 3463370-7Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other 150.00 MG C Company Report #9925631 PT Report Source Product Role Depression Consumer Zoloft Tablets PS Lithium Remeron Synthroid Hormone Replacement Perphenazine SS SS SS C C Manufacturer Route Duration ORAL TOTAL; DAILY; ORAL Date:02/23/00ISR Number: 3466903-XReport Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL Company Report #JAUSA36133 PT Report Source Product Role Coma Condition Aggravated Health Professional Risperdal (Risperidone) PS ORAL Zyprexa (Olanzapine) SS ORAL Lithium (Lithium) SS ORAL Prozac (Fluoxetine) C Suicide Attempt Manufacturer Route ORAL ORAL 22-Aug-2005 Page: 183 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3466916-8Report Type:Periodic Age:17 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged (1 MG 2 DAILY Company Report #JAUSA36236 PT Report Source Product Role Blood Creatine Phosphokinase Increased Health Professional Risperdal (Risperidone) PS Lithium (Lithium) SS Manufacturer Route Manufacturer Route Condition Aggravated 30-JUN-97):(2 MG DAILY 16-JAN-99) (16-JAN-99):D OSE INCREASED (NOS)600 MG 2 DAILY Date:02/24/00ISR Number: 3463237-4Report Type:Expedited (15-DaCompany Report #00P-163-0087101-00 (0) Age:32 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 24 MG 1 IN 1 PT Report Source Product Role Abnormal Behaviour Akathisia Health Professional Gabitril (Gabitril) (Tiagabine Hcl) PS ORAL Lithium Carbonate (Lithium Carbonate) SS ORAL Dyspnoea Seroquel (Seroquel) SS ORAL Fear Mental Impairment Muscle Contractions Involuntary Muscle Twitching Mtv(Vitamins Nos) Calcium (Calcium) Pyridoxine Hydrochloride (Pyridoxine C C Communication Disorder D PER ORAL Crying Drug Interaction 1050 MG 1 IN Dyskinesia 1 D PER ORAL PER ORAL Hydrochloride) Progesterone (Progesterone) Primidone (Primidone) C C C Date:02/28/00ISR Number: 3464828-7Report Type:Expedited (15-DaCompany Report #USA/00/00235/SIM03 Age:58 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 200 MG, TWICE PT Report Source Product Role Asthenia Confusional State Health Professional Sandimmune Neoral (Cyclosporine, Usp) PS Lithium SS Manufacturer Route ORAL Coordination Abnormal A DAY, ORAL Drug Interaction UNSPECIFIED Drug Level Above Therapeutic Drug Toxicity Hypertension Liver Function Test Abnormal Date:02/28/00ISR Number: 3466039-8Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200MG QD Initial or Prolonged ORAL 22-Aug-2005 Page: 184 10:48 AM PT Delirium Drug Toxicity Company Report # Report Source Product Role Lithium 300mg PS Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/00ISR Number: 3466292-0Report Type:Periodic Age:72 YR Gender:Female I/FU:I Outcome Dose Other 20 Company Report #WAES 99060264 PT Report Source Product Role Manufacturer Route Diarrhoea Health Tab Prinivil Unk PS ORAL Drug Interaction Professional Cap Lithiumco3 300 Mg SS ORAL Deltasone Fosamax Synthroid C C C Duration MG/DAILY/PO Drug Level Above Therapeutic 600; 900; 600 Memory Impairment MG/2XW/PO; 900; 600; 300 MG/DAILY/PO Date:03/01/00ISR Number: 3466978-8Report Type:Expedited (15-DaCompany Report #A003576 Age: Gender:Male I/FU:F Outcome Dose Duration Required Intervention to Prevent Permanent ORAL Impairment/Damage PT Report Source Product Role Drug Interaction Electrocardiogram Abnormal Health Professional Procardia Xl Extended Release Tablets PS Lithium Nardil Mellaril Yohimbine SS SS SS C Manufacturer Route ORAL Date:03/01/00ISR Number: 3467064-3Report Type:Expedited (15-DaCompany Report #FLUV00399000044 Age:37 YR Gender:Male I/FU:F Outcome Dose Other 50 MG DAILY PT Report Source Product Role Bite Foreign Fevarin PS Manufacturer Route Duration ORAL Depressed Level Of Health Consciousness Professional Fall Other PO Leponex SS Hypnorex - Slow Release SS Gastrozepin C 700 MG DAILY UNK, 725 MG Grand Mal Convulsion DAILY UNK, Joint Dislocation 800 MG DAILY UNK, 600 MG 800 MG DAILY UNK, 1000 MG DAILY UNK, 1200 MG DAILY UNK Date:03/02/00ISR Number: 3468284-4Report Type:Expedited (15-DaCompany Report #JACGER2000000226 Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization INTRAVENOUS DAILY, Initial or Prolonged PT Report Source Product Role Angina Pectoris IV Dyspnoea Hypokalaemia Foreign Haldol PS Health Professional Glianimon (Benperidol) SS Hypnorex (Lithium Carbonate) SS Ciatyl-Z Akuphase (Zuclopenthixol Acetate) SS DAILY DAILY, ORAL INTRAMUSCULAR DAILY, IM Ciatyl (Clopenthixol 22-Aug-2005 Page: 185 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report INTRAVENOUS Hydrochloride) C Diazepam Tavor Clexane C C C DAILY, IV Date:03/02/00ISR Number: 3473364-3Report Type:Expedited (15-DaCompany Report #LBID00200000843 Age:31 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600 MG DAILY Initial or Prolonged PO PT Report Source Product Role Bronchitis Health Lithobid PS ORAL Dehydration Professional Clozaril SS ORAL Depakote Ativan Prolixin C C C Drug Toxicity Manufacturer Route 200 MG DAILY Gait Disturbance PO Leukocytosis Myalgia Pyrexia Renal Failure Acute Vomiting Date:03/06/00ISR Number: 3470428-5Report Type:Expedited (15-DaCompany Report #HQ1275828FEB2000 Age:45 YR Gender:Female I/FU:F Outcome Dose Death PT Report Source Product Role Blood Pressure Increased Headache Health Professional Effexor (Venlafaxine Hydrochloride) PS Lithium (Lithium) SS Manufacturer Route Duration ORAL SEE IMAGE Photophobia Ruptured Cerebral Aneurysm Date:03/06/00ISR Number: 3470633-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000000398 Age:49 YR Gender:Female I/FU:F Outcome Dose PT Duration Report Source Product Role Manufacturer Route Blood Pressure Decreased Bradycardia Foreign Health Risperidone (Tablet) (Risperidone) PS ORAL Drug Interaction Sick Sinus Syndrome Professional Lithium Carbonate (Lithium Carbonate) SS ORAL Fluvoxamine Maleate (Fluvoxamine Maleate) SS ORAL Magnesium Oxide (Magnesium Oxide) C MG DAILY ORAL MG DAILY ORAL MG DAILY ORAL Date:03/08/00ISR Number: 3470848-9Report Type:Direct Age:48 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 186 10:48 AM PT Condition Aggravated Confusional State Drug Level Above Therapeutic Drug Toxicity Dysarthria Gait Disturbance Lethargy Polydipsia Tremor Urinary Incontinence Company Report # FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Dose Report Source Product Role Manufacturer Route Health Lithium 300mg Roxane PS Roxane ORAL Professional Chlorpromazine Valproate Triamcinolone Serosol Olanzapine Furosemide Oxybutin Ipratropium Albuterol Kcl Theophylline Lansoprazole Digoxin C C C C C C C C C C C C C Manufacturer Route Duration 300MG TID PO Date:03/10/00ISR Number: 3474118-4Report Type:Periodic Age:46 YR Gender:Female I/FU:I Outcome Dose Other 1 TABLET 1X Company Report #8-99137-155A PT Report Source Product Role Alopecia Consumer Lo/Ovral Tablet PS ORAL Lithium SS ORAL Wellbutrin SS ORAL Lithium Ritalin (Methylphenidate) Wellbutrin (Bupropion) C Duration PER DAY, ORAL ORAL ORAL Date:03/13/00ISR Number: 3474403-6Report Type:Direct Age:68 YR Gender:Male I/FU:I Company Report # C C Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Confusional State Coordination Abnormal Health Professional Lithium PS Date:03/13/00ISR Number: 3475326-9Report Type:Periodic Age:46 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 2TAB ORAL Initial or Prolonged 01X/D Manufacturer Route Manufacturer Route Company Report #6100640 PT Report Source Product Role Drug Interaction Consumer Aleve Caplets - 150s PS Lithobid (Lithium Carbonate) Lithobid (Lithium Carbonate) ORAL SS C Date:03/14/00ISR Number: 3475234-3Report Type:Expedited (15-DaCompany Report #2000-DE-G0035 Age:62 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 80/1/PO 900 MG/NR 22-Aug-2005 Page: 187 10:48 AM PT Report Source Product Role Coma Drug Level Above Foreign Health Micardis (Telmisartan) PS Therapeutic Professional Lithium Salt SS Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glimepiride Glucophage Isosorbide Mononitrate C C C Date:03/14/00ISR Number: 3475460-3Report Type:Expedited (15-DaCompany Report #2000014049JP Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 0.5 MG, PT Report Source Product Role Abnormal Behaviour Apathy Foreign Health Halcion (Triazolam) Tablet PS Delirium Dementia Alzheimer'S Type Professional Other Lithium Carbonate (Lithium Carbonate) SS Depression Drug Withdrawal Syndrome Maprotiline (Maprotiline) SS Electroencephalogram Abnormal Sultopride (Sultopride) SS Elevated Mood Etaxolam SS Mania Mental Impairment Nitrazepam (Nitrazepam) SS Restlessness Flunitrazepam (Flunitrazepam) SS Pentobarbital (Pentobarbital) SS Chlorpromazine (Chlorpromazine) SS Promethazine (Promethazine) SS Phenobarbital (Phenobarbital) SS 200 MG 70 MG 150 MG 4 MG 10 MG 4 MG 100 MG 25 MG 12.5 MG 40 MG Manufacturer Route Date:03/16/00ISR Number: 3476325-3Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report # PT Report Source Product Role Dehydration Health Professional Lithium PS Manufacturer Route Manufacturer Route Date:03/20/00ISR Number: 3477328-5Report Type:Expedited (15-DaCompany Report #A008797 Age:64 YR Gender:Female I/FU:I Outcome Dose Duration Required 6.00 GRAM Intervention to TOTAL:BID:ORA Prevent Permanent L Impairment/Damage 400.00 MG PT Report Source Product Role Gamma-Glutamyltransferase Foreign Unasyn For Injection PS ORAL Increased Health Lithium Carbonate SS ORAL Amoxapine Alprazolam Levomepromazine Maaleate C C Professional Company Representative TOTAL:BID:ORA L 22-Aug-2005 Page: 188 10:48 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/00ISR Number: 3477833-1Report Type:Expedited (15-DaCompany Report #WAES 00030893 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 25 Initial or Prolonged MG/DAILY/PO PT Report Source Product Role Confusional State Health Tab Vioxx 25 Mg PS Dialysis Professional Disorientation Company Lithium 450 Mg SS Drug Level Above Representative Manufacturer Route ORAL 450 MG/BID/UNK Therapeutic Date:03/21/00ISR Number: 3478586-3Report Type:Expedited (15-DaCompany Report #230941 Age:38 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Delirium Depressed Level Of Foreign Other Rivotril (Clonazepam) PS ORAL Anafranil (Clomipramine Hydrochloride) SS ORAL Atrium (Difebarbamate/Febar bamate/Phenobarbital ) SS ORAL Teralithe (Lithium Carbonate) SS ORAL Tercian (Cyamemazine) SS ORAL Theralene (Trimeprazine Tartrate) SS ORAL Consciousness Sedation Manufacturer Route ORAL ORAL ORAL ORAL ORAL Date:03/22/00ISR Number: 3482420-5Report Type:Expedited (15-DaCompany Report #WAES 00031459 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization PO Initial or Prolonged PO PT Report Source Product Role Disorientation Consumer Tab Vioxx Unk PS ORAL Lithium Co3 Unknown SS ORAL Drug Interaction Date:03/23/00ISR Number: 3479106-XReport Type:Direct Age:29 YR Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Manufacturer Imodium Eskalith PS SS Novopharm Limited Roxane Date:03/23/00ISR Number: 3479188-5Report Type:Expedited (15-DaCompany Report #A0111218A Age:50 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged Disability 10:48 AM PT Coordination Abnormal Dermatitis Drug Interaction Dysarthria Fatigue Malaise Mutism Nausea Nervous System Disorder Route Company Report #USP 52934 Duration Medication Error 22-Aug-2005 Page: 189 Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Petechiae Pharyngolaryngeal Pain Pyrexia Dose Report Source Product Role Manufacturer Route Health Professional Ziagen Tablet (Abacavir Sulfate) PS ORAL Lithium Carbonate Tablet (Lithium Carbonate) SS ORAL Combivir Thyroxine Sodium Trazodone Enalapril Maleate C C C C Duration Rash Maculo-Papular 300 MG, TWICE PER DAY, ORAL 300 MG, VARIABLE DOSE, ORAL Date:03/23/00ISR Number: 3479336-7Report Type:Direct Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Convulsion Encephalopathy Extrapyramidal Disorder Muscle Rigidity Pyrexia Rhabdomyolysis Company Report # Report Source Product Role Lithium 300 Mg PS Manufacturer Route Date:03/24/00ISR Number: 3479752-3Report Type:Expedited (15-DaCompany Report #A008820 Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged ORAL PT Report Source Product Role Abnormal Behaviour Literature Lithane Tablets PS ORAL Depression Health Haloperidol SS ORAL Feeling Abnormal Professional St. John'S Wort SS ORAL 900.00 MG Hallucination TOTAL:TID:ORA Inappropriate Affect L Libido Increased Mania Psychomotor Hyperactivity Speech Disorder Stress Date:03/24/00ISR Number: 3480106-4Report Type:Expedited (15-DaCompany Report #2000UW00926 Age:13 YR Gender:Female I/FU:I Outcome 22-Aug-2005 Page: 190 PT Blood Creatine Phosphokinase Increased Conjunctivitis 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Dehydration Drug Toxicity Leukopenia Report Source Product Role Manufacturer Route Mental Impairment Health Seroquel "Zeneca" PS Zeneca ORAL Muscle Rigidity Professional Seroquel "Zeneca" SS Zeneca ORAL Neuroleptic Malignant Risperdal SS ORAL Syndrome Risperdal SS ORAL Pyrexia Risperdal SS ORAL Loxitane Lithium Synthroid Depakote SS SS C C Duration 600 MG QD PO 400 MG BID PO 1 MG BID PO 3 MG QD PO 4 MG QD PO Date:03/24/00ISR Number: 3480312-9Report Type:Expedited (15-DaCompany Report #JRFBEL2000000398 Age:49 YR Gender:Female I/FU:F Outcome Dose PT Report Source Product Role Bradycardia Cardiac Output Decreased Foreign Health Risperidone (Tablet) (Risperidone) PS ORAL Condition Aggravated Professional Lithium Carbonate (Lithium Carbonate) SS ORAL Fluvoxamine Maleate (Fluvoxamine Maleate) SS ORAL Magnesium Oxide (Magnesium Oxide) C Manufacturer Route Duration MG, DAILY, ORAL Dizziness Drug Interaction MG, DAILY, Hypotension ORAL Kleptomania Nausea Sick Sinus Syndrome MG, DAILY, ORAL Date:03/24/00ISR Number: 3481078-9Report Type:Expedited (15-DaCompany Report #2000007354-1 Age:30 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 191 10:48 AM PT Report Source Product Blood Osmolarity Increased Confusional State Dehydration Headache Hemiparesis Hypernatraemia Nephrogenic Diabetes Insipidus Papilloedema Platelet Count Decreased Polyuria Renal Tubular Disorder Superior Sagittal Sinus Thrombosis Urine Osmolarity Decreased Vision Blurred Literature Health Professional Lithium Smithkline Beecham Oral Contraceptive (Nos) Risperidone Role Manufacturer PS Smithkline Beecham C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/00ISR Number: 3544612-6Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #USA012229 PT Report Source Product Role Manufacturer Confusional State Paranoia Thinking Abnormal Other Meridia PS Knoll Pharmaceutical Co Sub Basf Corp Lithium SS Route Duration Date:03/27/00ISR Number: 3480014-9Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 300 MG TID Initial or Prolonged ORAL PT Company Report # Report Source Product Role Lithium Carbonate 300 Mg PS ORAL Drug Toxicity Rofecoxib 25 Mg SS ORAL Nystagmus Oral Intake Reduced Tremor Visual Disturbance Stelazine Ditropan C C Coordination Abnormal Dialysis Manufacturer Route Difficulty In Walking 25MG QD ORAL Date:03/28/00ISR Number: 3480287-2Report Type:Direct Age:41 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 900M, PO BID, Initial or Prolonged TAB Disability 300 M PO BID Other TAB Required Intervention to Prevent Permanent Company Report # PT Report Source Product Role Manufacturer Route Hepatitis C Hepatocellular Damage Consumer Lithium Carbonate Tab Cr 900 M PS ORAL Clozapine Tab 300m SS ORAL Impairment/Damage Date:03/28/00ISR Number: 3481351-4Report Type:Expedited (15-DaCompany Report #00P-163-0087101-00 (1) Age:32 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 24 MG, 1 IN 1 PT Report Source Product Role Manufacturer Route Abnormal Behaviour Akathisia Health Professional Gabitril (Gabitril) (Tiagabine Hcl) PS ORAL Lithium Carbonate (Lithium Carbonate) SS ORAL Fear Seroquel (Seroquel) SS ORAL Mental Impairment Movement Disorder Muscle Twitching Psychomotor Hyperactivity Mtv (Vitamins Nos) Calcium (Calcium) Pyridoxine Hydrochloride (Pyridoxine Hydrochloride) Progesterone (Progesterone) Primidone (Primidone) C C Amnesia D, PER ORAL Anxiety Crying 1050 MG 1 IN Drug Interaction 1 D PER ORAL PER ORAL 22-Aug-2005 Page: 192 10:48 AM C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/00ISR Number: 3481502-1Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Depression Consumer Diflucan Tablets Lithium Unknown Antidepressant PS SS Manufacturer Route Manufacturer Route Duration Date:03/29/00ISR Number: 3481293-4Report Type:Direct Age:69 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Drug Level Above PO BID Initial or Prolonged Therapeutic INTRAMUSCULAR IM Q6H, PRN Lethargy SS Company Report # Report Source Date:03/29/00ISR Number: 3481824-4Report Type:Periodic Age:72 YR Gender:Female I/FU:I Outcome Dose Other 20 MG QD PO Company Report #9909532 Product Role Lithium 600 Mg PS Lorazepam 2 Mg SS ORAL Company Report #1999UW02015 PT Report Source Product Role Manufacturer Route Diarrhoea Health Lisinopril PS ORAL Drug Interaction Professional Lithium SS ORAL Therapeutic Lithium SS ORAL Memory Impairment Deltasone Fosamax Synthroid C C C Duration 600 MG DAILY Drug Level Above PO SEE IMAGE 9 DAY Date:03/31/00ISR Number: 3482771-4Report Type:Expedited (15-DaCompany Report #A008797 Age:64 YR Gender:Female I/FU:F Outcome PT Dose Duration Required Gamma-Glutamyltransferase INTRAVENOUS 6.00 GRAM Intervention to Increased TOTAL;BID;INT Prevent Permanent RAVENOUS Impairment/Damage 400.00 MG Report Source Product Role Foreign Unasyn For Injection PS Lithium Carbonate SS Amoxapine Alprazolam Levomepromazine Maleate C C Manufacturer Route Health Professional Company ORAL Representative TOTAL;BID;ORA L Date:04/03/00ISR Number: 3483006-9Report Type:Direct Age:33 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 193 10:48 AM PT Anxiety Drug Toxicity Feeling Jittery Hypothyroidism Tremor C Company Report # Report Source Product Role Lithium PS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/00ISR Number: 3484454-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000000200 Age:13 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Blood Creatine Phosphokinase Increased Conjunctivitis Health Professional Risperdal (1 Mg Tablet) (Risperidone) PS ORAL Dehydration Seroquel (Seroquel) SS ORAL Diabetes Mellitus Drug Level Above Loxitane (Loxitane Succinate) SS ORAL Therapeutic Lithium (Lithium) SS ORAL Drug Toxicity Hypertension Depakote (Valproate Semisodium) SS ORAL Lethargy Leukopenia Mental Impairment Muscle Rigidity Neuroleptic Malignant Syndrome Neutropenia Polyuria Pyrexia Tachycardia Tremor Fiber Lax (Polycarbophl Calcium) Synthroid (Levothyroxine Sodium) Trazodone (Trazodone) Cogentin (Benzatropine Mesilate) Colace (Docusate Sodium) Ddavrp (Desmopressin) Zoloft (Sertraline Hydrochloride) Lactaid (Tilactase) Erythromycin (Erythromycin) Lac-Hydrin (Ammonium Lactate) SEE IMAGE SEE IMAGE SEE IMAGE SEE IMAGE SEE IMAGE Date:04/06/00ISR Number: 3484838-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000000398 Age:49 YR Gender:Female I/FU:F C C C C C C C C C C Outcome Dose PT Report Source Product Role Manufacturer Route Bradycardia Cardiac Disorder Foreign Health Risperidone (Tablet) (Risperidone) PS ORAL Condition Aggravated Professional Lithium Carbonate (Lithium Carbonate) SS ORAL Fluvoxamine Maleate (Fluvoxamine Maleate) SS ORAL Magnesium Oxide (Magnesium Oxide) C Duration MG, DAILY, ORAL Dizziness Drug Interaction MG, Hypotension DAILY,ORAL Kleptomania Nausea Sick Sinus Syndrome MG, DAILY,ORAL Date:04/07/00ISR Number: 3485234-5Report Type:Direct Age:69 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 194 10:48 AM PT Coordination Abnormal Drug Toxicity Dysarthria Company Report # FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fall Tremor Report Source Dose Product Role Lithium Carbonate 300mg Cap PS Manufacturer Route Manufacturer Route Duration 600MG BID Date:04/07/00ISR Number: 3485273-4Report Type:Expedited (15-DaCompany Report #00P-163-0087101-00 (2) Age:32 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 24 MG, 1 IN 1 PT Report Source Product Role Abnormal Behaviour Akathisia Health Professional Gabitril (Gabitril) (Tiagabine Hcl) PS ORAL Lithium Carbonate (Lithium Carbonate) SS ORAL Dyspnoea Seroquel (Seroquel) SS ORAL Electroencephalogram Abnormal Fear Mental Disorder Movement Disorder Muscle Twitching Serotonin Syndrome Upper Respiratory Tract Infection Mtv (Vitamins Nos) Calcium (Calcium) Pyridoxine Hydrochloride (Pyridoxine Hydrochloride) Progesterone (Progesterone) Primidone (Primidone) C C Amnesia D, PER ORAL Anxiety Communication Disorder 1050 MG, 1 IN Drug Interaction 1 D, PER ORAL PER ORAL C C C Date:04/07/00ISR Number: 3485764-6Report Type:Expedited (15-DaCompany Report #00F--10078 Age:77 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Coma Dehydration Foreign Health Anafranil Tablet (Clomipramine Role Manufacturer Route Drug Interaction Professional Hydrochloride) PS ORAL Dysphagia Life Support Other Modopar Capsule (Madopar) SS ORAL Teralithe Slow Release Tablet (Lithium Carbonate) SS ORAL Deprenyl Tablet (Selegiline) SS ORAL Lysanxia Tablet C DAILY, ORAL 3 DF, DAILY, Motor Dysfunction ORAL 9 MON Neuropathy Peripheral Pyrexia Quadriplegia 800 MG, Rhabdomyolysis DAILY, ORAL Shock 10 MG, DAILY, ORAL Date:04/10/00ISR Number: 3485335-1Report Type:Direct Age:74 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG BID; PT Bradyphrenia Coordination Abnormal Company Report # Report Source Product Role Lithium Carbonate 300mg PS Lotrel (Ciba-Geigy) SS Manufacturer Drug Interaction YEARS Drug Level Above 1 WK Therapeutic Speech Disorder 22-Aug-2005 Page: 195 10:48 AM Ciba-Geigy Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/00ISR Number: 3488128-4Report Type:Expedited (15-DaCompany Report #2000009165-1 Age:61 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MILLIGRAM PT Report Source Product Role Manufacturer Blood Creatine Phosphokinase Increased Health Professional Lithium Smithkline Beecham PS Smithkline Beecham Blood Creatine Phosphokinase Mb Increased Chromaturia Coma Diarrhoea Drooling Drug Level Above Therapeutic Drug Toxicity Dysarthria Dysphagia Gait Disturbance Hyperphosphataemia Hypocalcaemia Hyporeflexia Hypotonia Liver Function Test Abnormal Malaise Motor Dysfunction Muscle Necrosis Myoglobinuria Nephrogenic Diabetes Insipidus Neuropathy Peripheral Pyrexia Renal Impairment Rhabdomyolysis Sensory Loss Tremor Vomiting Date:04/11/00ISR Number: 3488131-4Report Type:Expedited (15-DaCompany Report #2000009214-1 Age:76 YR Gender:Male I/FU:I Route Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 196 10:48 AM PT Report Source Product Role Manufacturer Aspiration Cough Dysphagia Dysphonia Dyspnoea Hyporeflexia Nasopharyngeal Disorder Oesophageal Stenosis Parkinsonism Productive Cough Weight Decreased Health Professional Lithium Smithkline Beecham Haloperidol Sertraline Temazepam PS C C C Smithkline Beecham Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/00ISR Number: 3488273-3Report Type:Direct Age:66 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600 MG PO BID Initial or Prolonged Company Report # PT Report Source Product Role Arrhythmia Health Lithium Carbonate PS Coma Dialysis Therapeutic Agent Toxicity Professional Manufacturer Route ORAL Date:04/18/00ISR Number: 3489429-6Report Type:Expedited (15-DaCompany Report #S00-FRA-00500-01 Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 40 MG QD PO PT Report Source Product Role Hypercalcaemia Hyperparathyroidism Foreign Health Seropram (Citalopram Hydrobromide) PS Professional Other Hygroton (Chlortalidone) Tenormine (Atenolol) SS SS Teralithe (Lithium Carbonate) SS Tercian (Cyamemazine) C 50 MG QD 1200 MG QD 25 MG QD Date:04/18/00ISR Number: 3489558-7Report Type:Expedited (15-DaCompany Report #2000010163-1 Age:66 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged PT Aggression Agitation Blood Creatinine Increased Blood Urea Increased Coma Confusional State Drug Level Above Manufacturer Route ORAL Therapeutic Dysphagia Haematocrit Decreased Haemoglobin Decreased Hyperglycaemia Hypoglycaemia Hyponatraemia Hypotension Jaundice Movement Disorder Oliguria Oxygen Saturation Decreased Pco2 Decreased Pneumonia Productive Cough Pyrexia Respiratory Rate Increased Restlessness Retching Skin Discolouration Speech Disorder Sputum Abnormal 22-Aug-2005 Page: 197 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Therapeutic Agent Toxicity Tremor Report Source Product Role Manufacturer Route Urinary Incontinence Consumer Eskalith PS Smithkline Beecham ORAL Product Role Manufacturer Route Lithium Co3 300 Mg PS ORAL Penicillin Vk 500 Mg SS ORAL Lisinopril Fluoxetine Insulin C C C Duration ORAL Health Professional Date:04/19/00ISR Number: 3489680-5Report Type:Direct Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG TID Initial or Prolonged ORAL PT Company Report # Report Source Dermatitis 500 MG QID ORAL Date:04/19/00ISR Number: 3490211-4Report Type:Expedited (15-DaCompany Report #00P-163-0087101-00 (3) Age:32 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 24 MG, 1 IN 1 PT Report Source Product Role Manufacturer Route Abnormal Behaviour Akathisia Health Professional Gabitril (Gabitril) (Tiagabine Hcl) PS ORAL Lithium Carbonate (Lithium Carbonate) SS ORAL Seroquel (Seroquel) SS ORAL Amnesia D, PER ORAL Anxiety Communication Disorder 1050 MG, 1 IN Crying 1 D, PER ORAL Drug Interaction PER ORAL Dyspnoea Electroencephalogram Abnormal Fear Mental Impairment Movement Disorder Muscle Twitching Restlessness Tremor Upper Respiratory Tract Infection Mtv (Vitamins Nos) Calcium (Calcium) Pyridoxine Hydrochloride (Pyridoxine) Progesterone (Progesterone) Primidone (Primidone) Date:04/21/00ISR Number: 3490998-0Report Type:Expedited (15-DaCompany Report #USA/00/00358/LEX Age:31 YR Gender:Male I/FU:F Outcome Life-Threatening Hospitalization Initial or Prolonged 22-Aug-2005 Page: 198 10:48 AM PT Blood Iron Decreased Bronchitis Dehydration Drug Toxicity Eosinophil Count Increased Eosinophilia Gait Disturbance Hypersensitivity Iron Metabolism Disorder Leukocytosis Myalgia C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Nausea Nephritis Interstitial Neuroleptic Malignant Report Source Product Role Syndrome Health Clozaril (Clozapine) PS Pyrexia Professional Lithobid (Lithium Carbonate) SS Depakote Ativan Prolixin C C C Manufacturer Route Duration ORAL 200 MG, UNKNOWN; ORAL Renal Failure Acute Vomiting 600 MG, UNKNOWN Date:05/01/00ISR Number: 3494762-8Report Type:Expedited (15-DaCompany Report #A013620 Age:30 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged ORAL Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Blood Osmolarity Literature Lithane Tablets PS ORAL Increased Health Oral Contraceptive SS ORAL Blood Sodium Increased Brain Scan Abnormal Confusional State Dehydration Headache Hemiparesis Nephrogenic Diabetes Insipidus Papilloedema Platelet Count Decreased Polyuria Superior Sagittal Sinus Thrombosis Thrombosis Urine Osmolarity Decreased Urine Sodium Decreased Vision Blurred Professional Risperidone C Date:05/01/00ISR Number: 3495052-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000001142 Age:27 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 199 10:48 AM PT Report Source Product Cerebellar Atrophy Computerised Tomogram Abnormal Convulsion Coordination Abnormal Depressed Level Of Consciousness Drug Interaction Electroencephalogram Abnormal Extensor Plantar Response Gait Disturbance Muscle Rigidity Nystagmus Speech Disorder Literature Health Professional Haldol (Unspecified) (Haloperidol) Lithium Carbonate (Lithium Carbonate) Diazepam (Diazepam) Role PS SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/00ISR Number: 3495005-1Report Type:Direct Age:44 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600 MG TID Initial or Prolonged Company Report # PT Report Source Product Role Delirium Health Lithium PS Feeling Jittery Mental Impairment Speech Disorder Professional Manufacturer Route Manufacturer Route Manufacturer Route Date:05/03/00ISR Number: 3496475-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000001143 Age:32 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged MG, DAILY MG, DAILY 3 PT Report Source Product Role Aggression Apathy Foreign Literature Haloperidol (Tablet) (Haloperidol) PS Brain Neoplasm Cerebellar Syndrome Health Professional Lithium Carbonate (Lithium Carbonate) SS Levomepromazin (Levomepromazine) C YR Coordination Abnormal Cough Diarrhoea Difficulty In Walking Drug Toxicity Dysarthria Intention Tremor Irritability Memory Impairment Osteosarcoma Localised Pyrexia Q Fever Speech Disorder Stupor Date:05/05/00ISR Number: 3497218-1Report Type:Expedited (15-DaCompany Report #00P-163-0089497-00 (0) Age:13 YR Gender:Female I/FU:I Outcome Dose Required PT Report Source Product Autonomic Nervous System Health Depakote (Depakote) Duration Role Intervention to 1500 MG, 1 IN Prevent Permanent 1 D, PER ORAL Impairment/Damage (SEE IMAGE) Imbalance Professional Blood Creatine Other (Divalproex Sodium) PS ORAL Risperidone (Risperidone) SS ORAL Seroquel (Seroquel) SS ORAL Loxapine Succinate (Loxapine Succinate) SS ORAL Lithium (Lithium) SS ORAL Phosphokinase Increased Conjunctivitis Dehydration 1 MG, 2 IN 1 Diabetes Mellitus D, PER ORAL Drug Level Above (SEE IMAGE) Therapeutic 600 MG, 1 IN Drug Toxicity 1 D, PER ORAL Enuresis (SEE IMAGE) Feeling Abnormal Hypertension 10 MG, 1 IN 1 Lethargy D, PER ORAL Leukopenia (SEE IMAGE) Mental Impairment 300 MG, 2 IN Muscle Rigidity 1 D, PER ORAL Neuroleptic Malignant (SEE IMAGE) Syndrome Neutropenia Pyrexia Tachycardia Tremor 22-Aug-2005 Page: 200 10:48 AM Polycarbophil Calcium (Polycarbophil Calcium) Levothyroxine Sodium (Levothyroxine C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) Trazodone (Trazodone) Benzatropine Mesilate (Benzatropine Mesilate) Docusate Sodium (Docusate Sodium) Desmopressin (Desmopressin) Sertraline Hydrochloride (Sertraline Hydrochloride) Tilactase (Tilactase) Erythromycin (Erythromycin) (Erythromycin) Ammonium Lactate (Ammonium Lactate) C C C C C C C C C Date:05/08/00ISR Number: 3497807-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000001143 Age:32 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Abnormal Behaviour Aggression Apathy Cerebellar Syndrome Foreign Literature Health Professional Haldol PS Rw Johnson Pharmaceutical Research Institute Div Ortho Pharm Coordination Abnormal Cough Lithium Carbonate (Lithium Carbonate) SS Depression Diarrhoea Difficulty In Walking Drug Level Above Therapeutic Drug Toxicity Dysarthria Intention Tremor Irritability Mental Disorder Due To A Levomepromazin (Levomepromazine) C MG, DAILY MG, DAILY 3 YR Route General Medical Condition Pyrexia Q Fever Stupor Date:05/10/00ISR Number: 3500120-XReport Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #17812-058 PT Report Source Product Role Manufacturer Route Insomnia Consumer Lithium Carbonate PS Roxane Laboratories, Inc. ORAL Duration 1500MG/DAY PO Clonazepam Synthroid 22-Aug-2005 Page: 201 10:48 AM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/00ISR Number: 3500122-3Report Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose Other Company Report #17812-059 PT Report Source Product Role Manufacturer Route Alopecia Weight Increased Health Professional Lithium Carbonate PS Roxane Laboratories, Inc. ORAL Abbott ORAL Duration 600 MG BID PO Depakote (Divalproex Sodium)-Abbott SS Synthroid C 500 MG TID PO Date:05/10/00ISR Number: 3500123-5Report Type:Periodic Age:58 YR Gender:Female I/FU:I Outcome Dose Other Company Report #18912-060 PT Report Source Product Role Manufacturer Route Hyperglycaemia Health Professional Lithium Carbonate PS Roxane Laboratories, Inc. ORAL Duration 1200MG TO 1350MG QHS PO Clorazepate Cytomel Seroquel Date:05/10/00ISR Number: 3500125-9Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Other C C C Company Report #17812-061 PT Report Source Product Role Manufacturer Route Diabetes Mellitus Health Professional Lithium Carbonate PS Roxane Laboratories, Inc. ORAL Duration 600MG AM, 900 MG PM PO Doxepin Valproic Acid Levotyroxine Fluazepam Diazepam Risperidal C C C C C C Date:05/10/00ISR Number: 3500128-4Report Type:Periodic Age:41 YR Gender:Female I/FU:I Outcome Dose Other Company Report #17812-062 PT Report Source Product Role Manufacturer Route Diabetes Mellitus Health Professional Lithium Carbonate PS Roxane Laboratories, Inc. ORAL Duration 900MG HS PO Date:05/10/00ISR Number: 3500135-1Report Type:Periodic Age:26 YR Gender:Female I/FU:I Outcome Dose Other 300MG TID PO PT Report Source Product Role Manufacturer Route Drug Ineffective Consumer Lithium Carbonate PS Roxane Laboratories, Inc. ORAL Duration 3 YR Date:05/10/00ISR Number: 3500138-7Report Type:Periodic Age:23 YR Gender:Female I/FU:I Outcome Dose Other Company Report #17812-063 Company Report #17812-064 PT Report Source Product Role Manufacturer Route Drug Ineffective Consumer Lithium Carbonate PS Roxane Laboratories, Inc. ORAL Duration 900MG QAM, 600MG QHS PO Seroquel Tablets 22-Aug-2005 Page: 202 10:48 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/00ISR Number: 3500140-5Report Type:Periodic Age:23 YR Gender:Male I/FU:I Outcome Dose Other Company Report #17812-065 PT Report Source Product Role Manufacturer Route Drug Ineffective Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 600MG BID PO Zoloft Seroquel Date:05/10/00ISR Number: 3500142-9Report Type:Periodic Age:59 YR Gender:Female I/FU:I Outcome Dose Other 300MG BID PO Company Report #17812-066 PT Report Source Product Role Manufacturer Route Pain Psoriasis Consumer Other Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 2 YR Date:05/10/00ISR Number: 3500151-XReport Type:Periodic Age:63 YR Gender:Female I/FU:I Outcome Dose Other C C Company Report #17812-067 PT Report Source Product Role Manufacturer Route Psoriasis Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 300MG BID PO Albuterol Serevent Pulmicort Turbuhaler Inhalation Powder Date:05/10/00ISR Number: 3500154-5Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300MG HS PO C C C Company Report #17812-068 PT Report Source Product Role Manufacturer Route Renal Impairment Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Other Prazosin Lisinopril Butabital Beconase Inhaler Date:05/10/00ISR Number: 3500157-0Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Other C C C C Company Report #17812-069 PT Report Source Product Role Manufacturer Route Dermatitis Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 700MG HS PO ALTERNATING WITH 350MG HS PO 11 YR Prozac Date:05/10/00ISR Number: 3500160-0Report Type:Periodic Age:19 YR Gender:Female I/FU:I Outcome Dose Other Company Report #17812-070 PT Report Source Product Role Manufacturer Route Convulsion Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 900 MG/DAY; 1200 MG/DAY (ALTERNATING 22-Aug-2005 Page: 203 C 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAYS) PO Date:05/10/00ISR Number: 3500162-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #17812-071 PT Report Source Product Role Manufacturer Route Abdominal Pain Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 900MG PO HS 2 YR Buspar Cytomel Date:05/10/00ISR Number: 3500165-XReport Type:Periodic Age:43 YR Gender:Male I/FU:I Outcome Dose Other Company Report #17812-072 PT Report Source Product Role Manufacturer Route Flatulence Oedema Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 600MG BID PO 20 YR Synthroid Date:05/10/00ISR Number: 3500167-3Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other C C C Company Report #17812-074 PT Report Source Product Role Manufacturer Route Headache Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Roxane Laboratories ORAL Duration 600 MG BID PO Lithium Carbonate Tablets Usp, 300 Mg Roxane Laboratories, Inc. SS Trilafon Benadryl C C 600 MG BID PO Date:05/10/00ISR Number: 3500168-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other INITIAL: Company Report #17812-075 PT Report Source Product Role Manufacturer Route Insomnia Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 300 MG BID PO / CURRENT: 600 MG HS PO Ambien (Zolpidem Tartrate) Klonopin (Clonazepam) Date:05/10/00ISR Number: 3500171-5Report Type:Periodic Age:57 YR Gender:Female I/FU:I Outcome Dose Other C C Company Report #17812-076 PT Report Source Product Role Manufacturer Route Vasodilatation Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 300MG TID, PO Xanax 22-Aug-2005 Page: 204 10:48 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/00ISR Number: 3500176-4Report Type:Periodic Age:51 YR Gender:Female I/FU:I Outcome Dose Other Company Report #17812-077 PT Report Source Product Role Manufacturer Route Pathological Fracture Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 300 MG QID PO Tylenol Extra Strength Tylenol With Codeine #3 Voltaren Or Oruvail Furosemide Univasc Zoloft Trazodone Date:05/10/00ISR Number: 3500179-XReport Type:Periodic Age:57 YR Gender:Female I/FU:I Outcome Dose Other C C C C C C C Company Report #17812-079 PT Report Source Product Role Manufacturer Route Amblyopia Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 300MG TID PO 1/2 Aspirin Accupril Tums Date:05/10/00ISR Number: 3500181-8Report Type:Periodic Age:35 YR Gender:Male I/FU:I Outcome Dose Other Company Report #17812-080 PT Report Source Product Role Manufacturer Route Dizziness Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 300 MG SIX TIMES/DAY PO C C C 2 MON Date:05/10/00ISR Number: 3500185-5Report Type:Periodic Age:49 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2 CAPS, BID & Company Report #17812-081 PT Report Source Product Role Manufacturer Route Overdose Health Professional Lithium Carbonate PS Roxane Laboratories Inc ORAL 1 CAP QD, PO Albuterol Amlodipine Carbamazepine Imipramine Ipatrophium Date:05/10/00ISR Number: 3500192-2Report Type:Periodic Age:69 YR Gender:Male I/FU:I Outcome Dose Other C C C C C Company Report #17812-082 PT Report Source Product Role Manufacturer Route Asthenia Dyspepsia Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 150MG TID PO Diazepam 22-Aug-2005 Page: 205 10:48 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/00ISR Number: 3499604-2Report Type:Expedited (15-DaCompany Report #2000007399-1 Age:71 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Manufacturer Route Constipation Drug Ineffective Consumer Paxil PS Smithkline Beecham Pharmaceuticals ORAL Dry Mouth Hyperglycaemia Insomnia Intentional Misuse Suicidal Ideation Suicide Attempt Tremor Eskalith (Lithium Carbonate) Smithkline Beecham Imipramine Amoxapine Elavil (Amitriptyline Hcl) Desipramine SS C C Smithkline Beecham C C Date:05/12/00ISR Number: 3500077-1Report Type:Expedited (15-DaCompany Report #00P-167-0089617-00 (0) Age:30 YR Gender:Male I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent 500 MG, 1 IN Impairment/Damage 1 D, PER ORAL PT Report Source Product Role Manufacturer Route Drug Level Changed Foreign Health Professional Depakene PS Abbott Laboratories Pharmaceutical Products Div ORAL Lithium Carbonate (Lithium Carbonate) SS Doxazosin Atenolol Lisniopril C C C 750 MG, 1 IN 1 D, PER ORAL; 650 MG, I IN I D, PER ORAL ORAL Date:05/12/00ISR Number: 3500084-9Report Type:Expedited (15-DaCompany Report #2000011924-1 Age:41 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1.0 DAILY Other PT Report Source Product Role Manufacturer Affect Lability Aggression Literature Health Eskalith PS Smithkline Beecham Pharmaceuticals Agitation Anxiety Excitability Grandiosity Mania Nephritis Interstitial Pressure Of Speech Renal Impairment Sleep Disorder Suspiciousness Tension Thinking Abnormal Professional Perphenazine Temazepam Lorazepam Nifedipine C C C C Date:05/15/00ISR Number: 3499835-1Report Type:Direct Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 206 10:48 AM PT Coordination Abnormal Decreased Appetite Dysarthria Company Report # Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Polydipsia Polyuria Tremor Dose Report Source Product Role Lithium PS Acebutolol Aciphex Ditropan Xl C C C Manufacturer Route Duration ORAL 600MG PO BID; PRIOR TO ADMISSION Date:05/15/00ISR Number: 3500695-0Report Type:Expedited (15-DaCompany Report #NL/00/01008/LEX Age:36 YR Gender:Female I/FU:I Outcome Dose Duration Death Hospitalization 25 MG, ONCE A Initial or Prolonged DAY, ORAL; 8 WK PT Report Source Product Role Manufacturer Route Complications Of Maternal Exposure To Therapeutic Foreign Health Clozaril PS Novartis Pharmaceuticals Corp ORAL Drugs Professional Foetal Disorder Hepatic Haemorrhage Other Route Lithii Carbonas (Lithium Carbonate) SS 400 MG, ONCE Hepatic Steatosis A DAY, Intra-Uterine Death Date:05/15/00ISR Number: 3501276-5Report Type:Expedited (15-DaCompany Report #10379097 Age:57 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Confusional State Initial or Prolonged Disorientation INTRAMUSCULAR 50 MILLIGRAM, Drug Level Above 1/3 WEEK IM Therapeutic Report Source Product Role Manufacturer Foreign Health Fluphenazine Hcl PS Apothecon Inc Div Bristol Myers Squibb Professional Other Teralithe (Lithium Fall Carbonate) SS ORAL Tegretol (Carbamazepine) SS ORAL Akineton (Biperiden Lactate) SS ORAL Diosmil (Diosmin) SS ORAL 500 MILLIGRAM, 1/1 DAY ORAL 400 MILLIGRAM, 1/1 DAY ORAL 8 MILLIGRAM, 1/1 DAY ORAL 600 MILLIGRAM, 1/1 DAY ORAL Date:05/16/00ISR Number: 3500817-1Report Type:Direct Age:66 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 207 10:48 AM PT Blood Ph Decreased Chest Pain Dialysis Drug Level Above Therapeutic Dyspnoea Encephalopathy Feeling Jittery Malaise Mental Impairment Company Report # FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pco2 Increased Urinary Incontinence Dose Report Source Product Role Health Eskalith PS Manufacturer Route Duration ORAL 40 MG BID PO Professional Date:05/16/00ISR Number: 3504279-XReport Type:Periodic Age:39 YR Gender:Male I/FU:I Outcome Dose Other Company Report #18421-004 PT Report Source Product Role Manufacturer Dermatitis Health Professional Lithium Citrate PS Roxane Laboratories Inc Benadryl-Prn C Route Duration 300MG TID Date:05/16/00ISR Number: 3504280-6Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #18421-005 PT Report Source Product Role Manufacturer Route Drug Ineffective Consumer Lithium Citrate PS Roxane Laboratories Inc ORAL Duration 3/4 TSP TID PO ALTERNATING WITH 1/2 TSP TID PO 1 YR Buspar Benedryl Date:05/16/00ISR Number: 3504281-8Report Type:Periodic Age: Gender:Female I/FU:I Company Report #18421-007 C C Outcome Dose Duration Hospitalization Initial or Prolonged TWO DOSES, PO Other PT Report Source Product Role Manufacturer Route Malaise Medication Error Health Professional Lithium Citrate PS Roxane Laboratories Inc ORAL Date:05/18/00ISR Number: 3501465-XReport Type:Expedited (15-DaCompany Report #A015018 Age:43 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Drug Interaction Mania Foreign Health Viagra PS Pfizer Agricultural Div ORAL Professional Lithium SS ORAL Date:05/18/00ISR Number: 3502207-4Report Type:Expedited (15-DaCompany Report #00P-056-0089833-00(0) Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Anorexia Apathy Blood Thyroid Stimulating Hormone Increased Depressed Mood Foreign Health Professional Tranxene (Tranxene) (Clorazepate Dipotassium) PS Abbott Laboratories Pharmaceutical Products Div ORAL PER ORAL Thyroid Neoplasm Thyroiditis Chronic Thyroxine Decreased PER ORAL 22-Aug-2005 Page: 208 10:48 AM Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zolpidem (Zolpidem) SS ORAL Lithium Carbonate (Lithium Carbonate) SS ORAL PER ORAL 500 MG, 1 IN 1 D, PER ORAL Date:05/19/00ISR Number: 3503630-4Report Type:Expedited (15-DaCompany Report #2000013810-1 Age:43 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL Other PT Report Source Drug Interaction Mania Product Role Manufacturer Route Eskalith Cr PS Smithkline Beecham Pharmaceuticals ORAL Route Viagra (Sildenafil) C Date:05/22/00ISR Number: 3503090-3Report Type:Expedited (15-DaCompany Report #2000014038-1 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Drug Toxicity Metabolic Encephalopathy Renal Impairment Consumer Eskalith PS Smithkline Beecham Pharmaceuticals Date:05/22/00ISR Number: 3503149-0Report Type:Expedited (15-DaCompany Report #00P-163-0087101-00 (4) Age:32 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Abnormal Behaviour Akathisia Amnesia Health Professional Gabitril PS Abbott Laboratories Pharmaceutical Products Div ORAL 24MG, 1 IN 1 Anxiety D, PER ORAL Communication Disorder Crying 1050 MG, 1 IN Lithium Carbonate (Lithium Carbonate) SS ORAL Drug Interaction 1 D, PER ORAL Dyskinesia Seroquel (Seroquel) SS Fear Mental Impairment Movement Disorder Muscle Twitching Tremor Upper Respiratory Tract Infection Mtv Calcium Pyridoxine Hydrochloride Progesterone Primidone C C ORAL PER ORAL Date:05/23/00ISR Number: 3503976-XReport Type:Periodic Age:50 YR Gender:Male I/FU:I Outcome Dose Other ORAL C C C Company Report #9917108 PT Report Source Product Role Manufacturer Route Depression Health Lithium Carbonate PS Pfizer Inc ORAL Drug Interaction Professional Zoloft SS Digoxin Diltiazem Hydrochloride C Duration ORAL 22-Aug-2005 Page: 209 10:48 AM C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/00ISR Number: 3503979-5Report Type:Periodic Age: Gender:Female I/FU:F Outcome Dose Other UNKNOWN Company Report #9911960 PT Report Source Product Role Manufacturer Hypothyroidism Health Lithium Carbonate PS Pfizer Inc Professional Synthroid Midrin Amantadine Potassium Chloride Risperidol Carbidopa/Levodopa Permax Captopril C C C C C C C C Route Duration Date:05/25/00ISR Number: 3505013-XReport Type:Expedited (15-DaCompany Report #B0081779A Age:29 YR Gender:Female I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Abortion Foreign Lamictal Lithium Salt (Formulation Unknown) (Lithium Salt) PS Glaxo Wellcome Inc Route SS Date:05/25/00ISR Number: 3506305-0Report Type:Expedited (15-DaCompany Report #2000008954-1 Age:23 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1350 PT Report Source Product Role Manufacturer Suicide Attempt Foreign Health Eskalith PS Smithkline Beecham Pharmaceuticals Professional MILLIGRAMS Other DAILY Efexor Xr (Venlafaxine) Staphylex (Flucloxacillin) C C Route Date:05/26/00ISR Number: 3505335-2Report Type:Expedited (15-DaCompany Report #FLUV00300002750 Age:26 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY PO, 150 PT Report Source Product Role Manufacturer Route Drug Interaction Fatigue Foreign Health Luvox PS Solvay Pharmaceuticals ORAL Myalgia Professional Pyrexia Other MG DAILY PO Hirnamin (Levomepromazine) SS ORAL Lexotan (Bromazepam) SS ORAL Solanax (Alprazolam) SS ORAL Lendormin (Brotizolam) SS ORAL Rohypnol (Flunitrazepam) SS ORAL Pyrethia (Promethazine Hydrochloride) SS ORAL 50 MG DAILY PO 4 MG DAILY PO 1.2 MG DAILY PO 0.25 MG DAILY PO 2 MG DAILY PO 50 MG DAILY PO 22-Aug-2005 Page: 210 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium Carbonate (Lithium Carbonate) SS ORAL 200 MG DAILY PO Date:05/26/00ISR Number: 3505613-7Report Type:Periodic Age:62 YR Gender:Female I/FU:I Outcome Dose Other Company Report #18558-012 PT Report Source Product Role Manufacturer Route Sedation Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 300MG BID PO/ MORE THAN 2 YEARS Date:05/26/00ISR Number: 3505616-2Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Other Company Report #18558-013 PT Report Source Product Role Manufacturer Route Dystonia Myasthenic Syndrome Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Route Duration 300 MG TID PO/ APPROXIMATELY 6 TO 7 YEARS Date:05/26/00ISR Number: 3505620-4Report Type:Periodic Age:45 YR Gender:Female I/FU:I Outcome Dose Other Company Report #18558-014 PT Report Source Product Role Manufacturer Keratoconjunctivitis Consumer Lithium Carbonate PS Roxane Laboratories Duration Sicca Inc 300MG Q 4 HRS Moban Prozac Ambien Date:05/26/00ISR Number: 3505632-0Report Type:Periodic Age:51 YR Gender:Female I/FU:I Outcome Dose Other 1 C C C Company Report #18558-015 PT Report Source Product Role Manufacturer Weight Increased Consumer Lithium Carbonate PS Roxane Laboratories Inc Seroquel Tablets Diazepam Tablets SS C Zeneca Laboratories Route Duration MON Date:05/26/00ISR Number: 3505633-2Report Type:Periodic Age:46 YR Gender:Female I/FU:I Outcome Dose Other Company Report #18558-016 PT Report Source Product Role Manufacturer Route Drug Interaction Oedema Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 300MG PO ONCE A DAY 17 YR Ceclor (Cefaclor) Eli Lilly & Co. 22-Aug-2005 Page: 211 10:48 AM SS Eli Lilly & Co. FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/00ISR Number: 3505634-4Report Type:Periodic Age:22 YR Gender:Male I/FU:I Outcome Dose Other Company Report #18558-017 PT Report Source Product Role Manufacturer Accidental Overdose Agitation Consumer Lithium Carbonate PS Roxane Laboratories Inc Route Duration 300 MG TID OR 900 MG ONCE A DAY;***MAY HAVE HAD 1800MG ONCE Date:05/26/00ISR Number: 3505635-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #18558-019 PT Report Source Product Role Manufacturer Route Asthenia Diarrhoea Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 300 TO 900MG Nausea DAILY, PO Vomiting Biaxin Date:05/26/00ISR Number: 3505642-3Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #18558-020 PT Report Source Product Role Manufacturer Route Alopecia Nausea Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 450MG DAILY PO X 1 WEEK THEN 45MG BID PO C Sertraline Hcl Alprazolam (Xanax) Spironolactone Oxycodone 5mg/Acetaminophen (Roxicet) Ibuprofen Otc Date:05/30/00ISR Number: 3505753-2Report Type:Direct Age:49 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 450MG Q8H Initial or Prolonged ORAL PT UNKNOWN ORAL Report Source Drug Toxicity Product Role Lithium 450mg PS Manufacturer Route ORAL Vomiting Company Report #1999-08-0894 PT Report Source Product Role Manufacturer Route Renal Impairment Skin Discolouration Consumer Trilafon PS Schering Corp Sub Schering Plough Corp ORAL Duration 10 YR Weight Increased UNKNWN ORAL 22-Aug-2005 Page: 212 C C Company Report # Date:05/30/00ISR Number: 3506850-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other C C C 10:48 AM Lithium SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/00ISR Number: 3507437-3Report Type:Direct Age:56 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Acidosis Blood Bicarbonate Increased Clonic Convulsion Confusional State Convulsion Drug Level Above Therapeutic Dyspnoea Oxygen Saturation Decreased Respiratory Failure Product Role Lithium PS Manufacturer Route Date:06/02/00ISR Number: 3507608-6Report Type:Expedited (15-DaCompany Report #A015018 Age:43 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Condition Aggravated Depression Foreign Health Viagra PS Pfizer Agricultural Div ORAL Drug Interaction Professional Lithium SS Dothiepin Flupentixol C C ORAL ORAL Mania Date:06/02/00ISR Number: 3507842-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000001423 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Agitation Akathisia Anxiety Literature Health Professional Risperdal PS Janssen Research Fdn Div Johnson And Johnson ORAL MG, DAILY, Bradykinesia ORAL Catatonia Lithium Carbonate Cognitive Disorder (Lithium Carbonate) SS Constipation Depression Paroxetine (Paroxetine) SS Drug Interaction Dry Mouth Olanzapine (Olanzapine) SS Fatigue Insomnia Benztropine (Benztropine) SS Irritability Nortriptyline SS MG, DIALY MG, DAILY MG, DAILY MG, DAILY MG, DAILY Mania Muscle Rigidity Parkinsonism Pressure Of Speech Pyrexia Thinking Abnormal Tremor Vision Blurred Date:06/02/00ISR Number: 3508206-0Report Type:Expedited (15-DaCompany Report #2000015366-1 Age:52 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 213 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Required Intervention to Dose Duration Prevent Permanent Impairment/Damage ORAL 10 YR PT Report Source Product Role Manufacturer Route Arthralgia Balance Disorder Consumer Eskalith Cr PS Smithkline Beecham Pharmaceuticals ORAL Manufacturer Route Bipolar Disorder Cerebellar Syndrome Choking Coma Communication Disorder Coordination Abnormal Decreased Activity Depressed Level Of Consciousness Depression Dialysis Difficulty In Walking Drug Level Above Therapeutic Drug Toxicity Dysarthria Dysphagia Encephalopathy Faecal Incontinence Fall Hyporeflexia Movement Disorder Muscular Weakness Nervous System Disorder Paranoia Renal Failure Acute Renal Impairment Rhinorrhoea Speech Disorder Suicide Attempt Urinary Incontinence Vitamin B12 Deficiency Depakote (Valproate Semisodium) Date:06/02/00ISR Number: 3566197-0Report Type:Periodic Age: Gender:Not SpecifiI/FU:I Outcome Dose PT Duration C Company Report #10291482 Report Source Product Role Drug Interaction Drug Toxicity Health Professional Avapro PS Lithium (Lithium Salts) SS 150 MILLIGRAM, 1/1 DAY 600 MILLIGRAM, 1 DAY Date:06/05/00ISR Number: 3508445-9Report Type:Expedited (15-DaCompany Report #WAES 00031459 Age: Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 214 10:48 AM PT Disorientation Drug Interaction Drug Level Above Therapeutic Sanofi Synthelabo Inc FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysarthria Therapeutic Agent Toxicity Dose Report Source Product Role Manufacturer Route Consumer Health Professional Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL Duration Urinary Incontinence 25 MG/DAILY/PO Lithiumco3 SS Oxybutynin Chloride C ORAL PO Date:06/05/00ISR Number: 3508772-5Report Type:Expedited (15-DaCompany Report #AUS/00/00230/LEX Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 950 MG, ORAL PT Report Source Product Role Manufacturer Route Cardiomyopathy Laboratory Test Abnormal Foreign Health Clozaril PS Novartis Pharmaceuticals Corp ORAL Professional Clonazepam SS Lithium SS Sodium Valproate Benztropine Amlodipine C C C Manufacturer Route 2 MG, TWICE A DAY 500 MG, ONCE A DAY, 750 MG, ONCE A DAY Date:06/06/00ISR Number: 3508774-9Report Type:Direct Age:51 YR Gender:Male I/FU:I Outcome Dose PT Duration Company Report # Report Source Product Role Life-Threatening SEE IMAGE Amnesia Neurotin PS Cognitive Disorder Klonapin SS Road Traffic Accident Lamictal SS Speech Disorder Lithium SS SEE IMAGE SEE IMAGE SEE IMAGE Visual Acuity Reduced Date:06/06/00ISR Number: 3566307-5Report Type:Periodic Age: Gender:Not SpecifiI/FU:I Outcome Dose Company Report #HQ5466305MAY2000 PT Report Source Product Role Manufacturer Route Drug Interaction Hallucination Health Professional Sonata PS Wyeth Ayerst Laboratories Inc ORAL Company Representative Lithium Manufacturer Route Duration ORAL Date:06/08/00ISR Number: 3509814-3Report Type:Direct Age:41 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 500MG QHS PO Initial or Prolonged 600MG BID PO Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 215 10:48 AM PT SS Company Report # Report Source Product Role Blood Creatine Phosphokinase Increased Clozaril 500mg Qhs Po PS ORAL Circulatory Collapse Lithium 600mg Bid Po SS ORAL Coma Pyrexia Tachycardia Neurontin Bowel Regimen C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/00ISR Number: 3564782-3Report Type:Periodic Age:13 YR Gender:Female I/FU:I Outcome Dose Company Report #2000UW00926 PT Report Source Product Role Manufacturer Route Conjunctivitis Health Seroquel PS Astrazeneca Uk Ltd ORAL Dehydration Professional Seroquel SS ORAL Drug Toxicity Risperdal SS ORAL Neuroleptic Malignant Risperdal SS ORAL Syndrome Risperdal SS ORAL White Blood Cell Count Decreased Loxitane Lithium Synthroid Depakote SS SS C C Duration 600 MG QD PO 600 MG QD PO 1 MG BID PO 3 MG PO 4 MG QD PO Date:06/09/00ISR Number: 3510697-6Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 1500MG DAILY Initial or Prolonged ORAL Required 5MG QD ORAL Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Product Role Lithium Carbonate 300mg PS ORAL Therapeutic Lisinopril SS ORAL Dysarthria Mental Impairment Renal Impairment Tremor Asa Chlorpromazine Glyburide Lisinopril Lithium C C C C C Asthenia Blood Creatine Increased Manufacturer Route Drug Level Above Date:06/09/00ISR Number: 3510934-8Report Type:Expedited (15-DaCompany Report #WAES 00060222 Age:68 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization Initial or Prolonged Cerebrovascular Accident Confusional State Drug Interaction Health Professional Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL 12.5 Speech Disorder MG/DAILY/PO Lithiumco3 SS Fosamax Klonopin Calcium Supplement Nortriptyline Thyroid C C C C C 600 MG/DAILY/UNK Date:06/12/00ISR Number: 3511767-9Report Type:Expedited (15-DaCompany Report #WAES 00060222 Age:67 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Confusional State Coordination Abnormal Drug Interaction Health Professional Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL 12.5 Drug Toxicity MG/DAILY/PO 5 DAY Dysarthria Lithiumco 3 SS Speech Disorder Tremor Allegra Fosamax Klonopin Levoxyl Calcium Supplement Nortriptyline C C C C C C 600 MG, DAILY 22-Aug-2005 Page: 216 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thyroid C Date:06/12/00ISR Number: 3512169-1Report Type:Expedited (15-DaCompany Report #2000-DE-G0035 Age:62 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 80/1/PO Initial or Prolonged 900 MG PT Report Source Product Role Manufacturer Route Coma Foreign Micardis PS Boehringer Ingelheim ORAL Drug Level Above Health Lithium Salt SS Therapeutic Professional Glimepiride Glucophage Isosorbide Mononitrate C C Manufacturer Route C Date:06/12/00ISR Number: 3512475-0Report Type:Expedited (15-DaCompany Report #EWC000506839 Age:33 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 3600 MG/DAY Initial or Prolonged 7.5 MG/DAY PT Report Source Product Role Depression Foreign Lithium PS Suicide Attempt Study Olanzapine SS Health Professional Other Lorazepam C Date:06/15/00ISR Number: 3514186-4Report Type:Expedited (15-DaCompany Report #A019091 Age:56 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Manufacturer Route Alcohol Withdrawal Foreign Lithium Carbonate PS Pfizer Inc ORAL Syndrome Chronic Obstructive Airways Disease Exacerbated Drug Level Above Health Professional Risperidone Oxazepam Flurazepam Citalopram C C C C Therapeutic Malaise Metabolic Acidosis Date:06/15/00ISR Number: 3514417-0Report Type:Expedited (15-DaCompany Report #2000016923-1 Age:20 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 450 PT Report Source Product Role Manufacturer Route Aggression Blister Consumer Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Colitis Ulcerative MILLIGRAMS Condition Aggravated 2.0 DAILY Dehydration ORAL 2 YR Diarrhoea Large Intestinal Ulcer Mental Disorder Psychotic Disorder Vomiting 22-Aug-2005 Page: 217 10:48 AM Risperdal (Risperidone) C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/00ISR Number: 3514533-3Report Type:Expedited (15-DaCompany Report #A018216 Age:49 YR Gender:Female I/FU:I Outcome Dose Disability PT Report Source Product Role Manufacturer Route Confusional State Disturbance In Attention Foreign Health Zoloft PS Pfizer Pharmaceuticals Inc ORAL Memory Impairment Professional Duration 25.00 MG TOTAL: Reading Disorder DAILY:ORAL Thinking Abnormal Lithium SS Clonazepam C ORAL DAILY:ORAL Date:06/19/00ISR Number: 3515827-8Report Type:Expedited (15-DaCompany Report #2000017081-1 Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Drug Interaction Drug Level Above Therapeutic Product Role Manufacturer Eskalith PS Smithkline Beecham Pharmaceuticals Ciprofloxacin Oxybutynin Senna Thioridazine Venlafaxine C C C C C Route Date:06/21/00ISR Number: 3521931-0Report Type:Expedited (15-DaCompany Report #2000-06-0664 Age:56 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SUBCUTANEOUS PT Dehydration Diarrhoea Drug Toxicity 15 MU QD Report Source Product Role Foreign Other Intron A (Interferon Alfa-2b Recombinant) Soluble Powder PS Camcolit SS Manufacturer Route SUBCUTANEOUS 1000 MG QD ORAL ORAL Furosemide SS Cardura Metformin Zocor C C C 40 MG QD ORAL Date:06/22/00ISR Number: 3518280-3Report Type:Expedited (15-DaCompany Report #2000015366-1 Age:52 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged Other Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 218 10:48 AM PT Arthralgia Asthenia Blood Creatinine Increased Blood Urea Increased Cerebellar Syndrome Cerebral Ischaemia Cerebrovascular Accident Choking Coordination Abnormal Decreased Activity Dehydration Delirium Depressed Level Of Consciousness Depression Dialysis ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Difficulty In Walking Drug Level Above Therapeutic Dose Drug Toxicity Dysarthria ORAL Report Source Product Role Manufacturer Route Consumer Eskalith Cr PS Smithkline Beecham Pharmaceuticals ORAL Duration 10 YR Dysphagia Encephalopathy Eskalith Smithkline Beecham SS 675 Faecal Incontinence MILLIGRAMS Fall 2.0 DAILY Gait Disturbance ORAL Hyporeflexia Hypovolaemia Motor Dysfunction Muscular Weakness Nephrogenic Diabetes Insipidus Nervous System Disorder Nuclear Magnetic Resonance Imaging Abnormal Overdose Pernicious Anaemia Pneumonia Aspiration Renal Failure Renal Failure Acute Renal Impairment Rhinorrhoea Speech Disorder Suicide Attempt Urinary Incontinence Urinary Retention Urinary Tract Infection Vitamin B12 Absorption Test Abnormal Vitamin B12 Deficiency Date:06/22/00ISR Number: 3567922-5Report Type:Periodic Age:40 YR Gender:Female I/FU:I Depakote (Valproate Semisodium) Synthroid (Levothroxine) Effexor (Venlafaxine Hydrochloride) Restoril Company Report #WAES 00030770 C C C C ORAL Outcome Dose PT Report Source Product Role Manufacturer Route Drug Interaction Drug Level Above Therapeutic Health Professional Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL Duration SEE IMAGE Lithiumco 3 300mg;Lithiumco3 SS ... C 600 MG/TID;300 MG/BID 300 MG/BID Date:06/23/00ISR Number: 3518631-XReport Type:Expedited (15-DaCompany Report #HQ7402515JUN2000 Age:63 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 219 10:48 AM PT Body Temperature Decreased Bradycardia Hypotension Overdose Sedation FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Vomiting Dose Report Source Product Role Manufacturer Route Health Professional Effexor PS Wyeth Ayerst Laboratories Inc ORAL Duration 1350 MG Other OVERDOSE AMOUNT ORAL 1 DAY Atenolol (Atenolol) SS ORAL Lithium (Lithium) SS ORAL Thioridazine (Thioridazine) SS ORAL 350 MG OVERDOSE AMOUNT ORAL 1 DAY 2800 MG OVERDOSE AMOUNT ORAL 1 DAY 525 MG OVERDOSE AMOUNT ORAL 1 DAY Date:06/29/00ISR Number: 3522625-8Report Type:Expedited (15-DaCompany Report #2000018625-1 Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 800 PT Report Source Product Role Manufacturer Alpha 2 Globulin Increased Literature Health Eskalith PS Smithkline Beecham Pharmaceuticals Anaemia Professional Biperiden Doxepin C C MILLIGRAMS Blood Albumin Decreased DAILY Blood Urea Increased Cerebellar Ataxia Route Diarrhoea Drug Level Above Therapeutic Dysarthria Glomerulonephritis Proliferative Haemoglobin Decreased Hypercholesterolaemia Lethargy Leukopenia Nephrotic Syndrome Oedema Pleural Effusion Polyuria Proteinuria Haloperidol Date:06/30/00ISR Number: 3523153-6Report Type:Expedited (15-DaCompany Report #NL/00/01265/TER Age:39 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 220 10:48 AM PT Clonic Convulsion Convulsion Drug Interaction Drug Level Above Therapeutic Dysarthria Muscle Contractions Involuntary Overdose Sedation Speech Disorder C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stupor Tremor Vomiting Dose Report Source Product Role Manufacturer Route Foreign Health Sanorex PS Novartis Pharmaceuticals Corp ORAL Duration 1 MG, ONCE A Professional DAY, ORAL Other Lithli Carbonas (Lithium Carbonate) SS 800 MG, ONCE A DAY Efexor (Venlafaxine Hydrochloride) Cisordinol Depot (Clopenthixol Hydrochloride) Minrin (Desmopressin) C C C Date:07/03/00ISR Number: 3523586-8Report Type:Expedited (15-DaCompany Report #WAES 00064287 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Disability PO 4 WK PT Report Source Product Role Manufacturer Route Pain Tremor Consumer Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL Lithiumco3 SS Date:07/03/00ISR Number: 3523624-2Report Type:Expedited (15-DaCompany Report #2000018942-1 Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 750 PT Report Source Product Role Manufacturer Route Blood Urea Increased Condition Aggravated Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Confusional State MILLIGRAMS Coordination Abnormal ORAL 5 YR Delirium Drug Interaction Grandiosity Mania Medication Error Ciproflaxacin Conjugated Estrogens Glyburide L-Tryptophan Lorazepam Quetiapine Valsartan C C C C C C C Date:07/03/00ISR Number: 3523891-5Report Type:Expedited (15-DaCompany Report #2000018615-1 Age:60 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Apnoea Cardio-Respiratory Arrest Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Duration 1125 Depression MILLIGRAMS Diabetes Mellitus ORAL 3 DAY Drug Level Above Therapeutic Mania Pulse Absent Sedation 22-Aug-2005 Page: 221 10:48 AM Amaryl (Glimepirid) Heparin Orfiril (Valproat) Pirenzepin (Pirenzepin) Risperdal (Risperidon) Truxal C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Chlorprothixen) Eskalith C C Smithkline Beecham Pharmaceuticals Date:07/03/00ISR Number: 3524076-9Report Type:Expedited (15-DaCompany Report #2000015366-1 Age:52 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE 10 YR Other Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Asthenia Balance Disorder Consumer Health Eskalith Cr PS Smithkline Beecham Pharmaceuticals ORAL Blood Creatinine Increased Blood Potassium Abnormal Carpal Tunnel Syndrome Choking Confusional State Convulsion Coordination Abnormal Dehydration Depressed Level Of Consciousness Depression Diabetes Insipidus Dialysis Difficulty In Walking Disorientation Disturbance In Attention Drug Toxicity Dysarthria Dyskinesia Dysphagia Encephalopathy Eye Injury Faecal Incontinence Fall Fatigue Feeding Disorder Hypernatraemia Hyperreflexia Ischaemic Stroke Memory Impairment Meningitis Mental Impairment Neck Pain Professional Depakote (Valproate Semisodium) Synthroid (Levothyroxine) Effexor (Venlafaxine Hydrochloride) Restoril (Famotidine) C C C C Neurological Symptom Pain In Extremity Paraesthesia Paranoid Personality Disorder Pneumonia Aspiration Psychotic Disorder Pyrexia Reflexes Abnormal Renal Failure Acute Rhinorrhoea Sepsis Speech Disorder Tremor Urinary Incontinence Vitamin B12 Deficiency 22-Aug-2005 Page: 222 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/03/00ISR Number: 3524777-2Report Type:Expedited (15-DaCompany Report #00HQ-10279 Age:51 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Confusional State Coordination Abnormal Foreign Literature Diovan PS Novartis Pharmaceuticals Corp Delirium Health Drug Interaction Drug Level Above Therapeutic Professional Other Lithium Carbonate Unknown (Lithium Carbonate) Glyburide Lorazepam L-Tryptophan Estrogens Ciprofloxacin SS C C C C C Route Duration 80 MG, DAILY, UNKNOWN Date:07/03/00ISR Number: 3524842-XReport Type:Expedited (15-DaCompany Report #A020604 Age:35 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 20.00 MG Initial or Prolonged TOTAL DAILY PT Report Source Product Role Manufacturer Route Arthralgia Back Pain Foreign Health Feldene PS Pfizer Laboratories Div Pfizer Inc ORAL Coma Professional Depressed Level Of Company Consciousness Representative ORAL Lithium SS Carbamazepine Amitriptylin Levotiroxine Levopromacine Lormetazepam C C C C C TID, ORAL Drug Interaction Drug Level Above Therapeutic Drug Toxicity Proteus Infection Pyrexia Sepsis Date:07/05/00ISR Number: 3524271-9Report Type:Direct Age:43 YR Gender:Male I/FU:I Company Report # ORAL Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged PT Report Source Drug Toxicity Hypernatraemia Psychotic Disorder Renal Failure Product Role Lithium PS Manufacturer Route Route Date:07/05/00ISR Number: 3524320-8Report Type:Expedited (15-DaCompany Report #239346 Age:60 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Foreign Study Valium PS Hoffmann La Roche Inc Quilonium Retard (Lithium Carbonate) SS Orfiril (Valproate Sodium) SS Truxal (Chlorprothixene) SS Duration Drug Level Above Therapeutic 30 MG DAILY ; Mania INTRAVENOUS Health 10 MG DAILY Pulse Absent Professional INTRAVENOUS Respiratory Arrest Stupor 1350 MG DAILY 600 MG DAILY INTRAVENOUS 150 MG DAILY; 100 MG INTRAVENOUS ; 100 MG DAILY 22-Aug-2005 Page: 223 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Risperdal (Risperidone) SS 6 MG DAILY Amaryl (Glimepiride) Pirenzepine (Pirenzepine Hydrochloride) Heparin (Heparin Sodium) Date:07/06/00ISR Number: 3525322-8Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PO 300MG Q AM PT C C C Company Report # Report Source Bradycardia Product Role Lithium Cr PS Carbamazepine SS Manufacturer Route ORAL Cardiac Arrest & 900GM HS Syncope 100MG Q AM/200 Q PM Date:07/06/00ISR Number: 3525788-3Report Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200000012 PT Report Source Product Role Manufacturer Route Hypersensitivity Tremor Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration QD PO Tegretol Klonopin Synthroid Estrace Claritin Date:07/06/00ISR Number: 3525790-1Report Type:Periodic Age:55 YR Gender:Male I/FU:I Company Report #LBID00200000084 C C C C C Outcome Dose Other PT Report Source Product Role Manufacturer Route Dysgeusia Insomnia Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG QD PO; QD PO Serzone Xanax Date:07/06/00ISR Number: 3525792-5Report Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose Other C C Company Report #LBID00200000239 PT Report Source Product Role Manufacturer Route Psoriasis Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG QD PO Premarin Klonopin Maxzide Zoloft Methotrexate 22-Aug-2005 Page: 224 10:48 AM C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/00ISR Number: 3525796-2Report Type:Periodic Age:55 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200000337 PT Report Source Product Role Manufacturer Route Abnormal Dreams Amnesia Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 1200 MG DAILY Weight Increased PO Nardil Date:07/06/00ISR Number: 3525801-3Report Type:Periodic Age:38 YR Gender:Male I/FU:I Outcome Dose Other C Company Report #LBID00200000387 PT Report Source Product Role Manufacturer Route Drug Interaction Drug Level Above Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY, Therapeutic PO, 300 MG Dyspepsia BID PO Influenza Like Illness Celebrex (Celecoxib) SS Bupropion Clonazepam Risperidone Lamotrigine C C C C ORAL 200 MG DAILY Tremor PO Date:07/06/00ISR Number: 3525803-7Report Type:Periodic Age:8 YR Gender:Male I/FU:I Outcome Dose Other 600 MG DAILY PO Company Report #LBID00200000431 PT Report Source Product Role Manufacturer Route Hormone Level Abnormal Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration Depakote Wellbutrin Ritalin Date:07/06/00ISR Number: 3525811-6Report Type:Periodic Age:39 YR Gender:Female I/FU:I Outcome Dose Other C C C Company Report #LBID00200000447 PT Report Source Product Role Manufacturer Route Drug Interaction Sedation Foreign Literature Lithobid PS Solvay Pharmaceuticals ORAL Duration 400 MG DAILY, Other PO, 800 MG DAILY PO Luvox (Fluvoxamine Maleate) SS ORAL DAILY, PO Date:07/06/00ISR Number: 3525813-XReport Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00200000506 PT Report Source Product Role Manufacturer Route Depersonalisation Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 1200 MG DAILY Company PO Representative 22-Aug-2005 Page: 225 10:48 AM Desipramine Prozac C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/00ISR Number: 3525815-3Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Other Company Report #LBID00200000616 PT Report Source Product Role Manufacturer Route Hypernatraemia Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Company Representative Neurontin Duration DAILY PO Date:07/06/00ISR Number: 3525817-7Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose Other C Company Report #LBID00200000651 PT Report Source Product Role Manufacturer Route Dermatitis Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 600 MG DAILY PO, 900 MG DAILY PO Effexor Buspar Date:07/06/00ISR Number: 3525854-2Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose Other C C Company Report #LBID00200000697 PT Report Source Product Role Manufacturer Route Nausea Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration DAILY, PO, 900 MG DAILY PO Date:07/06/00ISR Number: 3525867-0Report Type:Periodic Age:68 YR Gender:Female I/FU:I Company Report #LBID00200000793 Outcome Dose Other PT Report Source Product Role Manufacturer Route Face Oedema Paraesthesia Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 600 MG DAILY PO Premarin Levoxyl Ambien Hyzaar Date:07/06/00ISR Number: 3525868-2Report Type:Periodic Age:46 YR Gender:Male I/FU:I Outcome Dose Other C C C C Company Report #LBID00200000809 PT Report Source Product Role Manufacturer Route Tremor Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY PO Zoloft Paxil Clonazepam Zyrtec 22-Aug-2005 Page: 226 10:48 AM C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/00ISR Number: 3525870-0Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00200000816 PT Report Source Product Role Manufacturer Route Blood Creatinine Increased Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration DAILY PO Renal Impairment Date:07/06/00ISR Number: 3525871-2Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00200000818 PT Report Source Product Role Manufacturer Route Erectile Dysfunction Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY PO, 600 MG DAILY PO, 900 MG DAILY PO Date:07/06/00ISR Number: 3525872-4Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00200000967 PT Report Source Product Role Manufacturer Route Dermatitis Pruritus Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Manufacturer Route Duration 600 MG BID PO Zyprexa Wellbutrin Date:07/06/00ISR Number: 3525874-8Report Type:Periodic Age:58 YR Gender:Female I/FU:I Outcome Dose PT Duration C C Company Report #LBID00200001089 Report Source Product Role Other Arthralgia Oedema Peripheral Consumer Lithobid PS Solvay Pharmaceuticals ORAL 300 MG QD PO Tremor Vomiting Date:07/06/00ISR Number: 3525875-XReport Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200001646 PT Report Source Product Role Manufacturer Route Hormone Level Abnormal Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 1200 MG DAILY PO Date:07/06/00ISR Number: 3525876-1Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Diarrhoea Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG BID PO 22-Aug-2005 Page: 227 Company Report #LBID00200001647 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/00ISR Number: 3525877-3Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200002115 PT Report Source Product Role Manufacturer Route Headache Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG DAILY PO Date:07/06/00ISR Number: 3525878-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200002129 PT Report Source Product Role Manufacturer Route Diarrhoea Intentional Misuse Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration DAILY PO Nausea Date:07/06/00ISR Number: 3525882-7Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200002369 PT Report Source Product Role Manufacturer Route Acne Salivary Hypersecretion Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration PO, 450 MG Weight Increased BID PO Lithonate (Lithium Carbonate) SS Depakote Zoloft C C 300 MG QD PO Date:07/06/00ISR Number: 3525885-2Report Type:Periodic Age: Gender: I/FU:I Company Report #LBID00200002457 ORAL Outcome Dose Other PT Report Source Product Role Manufacturer Route Dermatitis Oedema Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG BID PO Date:07/06/00ISR Number: 3525886-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200002464 PT Report Source Product Role Manufacturer Route Psoriasis Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG BID PO, 300 MG BID PO Date:07/06/00ISR Number: 3525891-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00299000155 PT Report Source Product Role Manufacturer Route Drug Ineffective Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration MG QD PO Lithobid (Lithium Carbonate) Eskalith 22-Aug-2005 Page: 228 10:48 AM SS C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/00ISR Number: 3525893-1Report Type:Periodic Age:7 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00299000171 PT Report Source Product Role Manufacturer Route Flatulence Pallor Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 600 MG QD PO 10 DAY Sedation Date:07/06/00ISR Number: 3525895-5Report Type:Periodic Age:35 YR Gender:Male I/FU:I Outcome Dose Other PT Company Report #LBID00299000249 Report Source Product Role Manufacturer Route Lithobid PS Solvay Pharmaceuticals ORAL Duration Depression 600 MG BID PO Acidophilus "Zyma" (Lactobacillus Acidophilus) SS Serzone Levoxyl C C DAILY Date:07/06/00ISR Number: 3525898-0Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00299000256 PT Report Source Product Role Manufacturer Route Hallucination Consumer Lithobid PS Solvay Pharmaceuticals ORAL Manufacturer Route Duration 1500 MG QD PO Zyprexa Excedrin Date:07/06/00ISR Number: 3525900-6Report Type:Periodic Age:14 YR Gender:Female I/FU:I Outcome Dose PT Duration C C Company Report #LBID00299000257 Report Source Product Role Other Laboratory Test Abnormal Tremor Consumer Lithobid PS Solvay Pharmaceuticals ORAL Route 300 MG TID PO Wellbutrin Date:07/06/00ISR Number: 3525902-XReport Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other C Company Report #LBID00299000358 PT Report Source Product Role Manufacturer Hypoglycaemia Consumer Lithobid PS Solvay Pharmaceuticals Wellbutrin C Duration DAILY Date:07/06/00ISR Number: 3525904-3Report Type:Periodic Age:54 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00299000450 PT Report Source Product Role Manufacturer Route Amblyopia Asthenia Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG BID PO Celexa 22-Aug-2005 Page: 229 10:48 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/00ISR Number: 3525905-5Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00299000486 PT Report Source Product Role Manufacturer Drug Level Above Therapeutic Health Professional Lithobid PS Solvay Pharmaceuticals Cortisone Injection (Cortisone) SS Route Duration DAILY INTRAMUSCULAR Hypercalcaemia Mania DAILY IM Date:07/06/00ISR Number: 3525907-9Report Type:Periodic Age:61 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00299000529 PT Report Source Product Role Manufacturer Route Convulsion Tremor Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG QD PO Desipramine Diazepam Prempro Date:07/06/00ISR Number: 3525921-3Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other C C C Company Report #LBID00299000538 PT Report Source Product Role Manufacturer Route Weight Increased Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY PO Zoloft Premarin Date:07/06/00ISR Number: 3525923-7Report Type:Periodic Age:50 YR Gender:Male I/FU:I Company Report #LBID00299000555 C C Outcome Dose Other PT Report Source Product Role Manufacturer Aggression Health Professional Lithobid PS Solvay Pharmaceuticals Route Duration 300 MG TID PO IN Date:07/06/00ISR Number: 3525925-0Report Type:Periodic Age:45 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00299000625 PT Report Source Product Role Manufacturer Route Hyperkalaemia Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 600 MG BID PO Date:07/06/00ISR Number: 3525926-2Report Type:Periodic Age:50 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00299000633 PT Report Source Product Role Manufacturer Route Pollakiuria Tremor Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY PO, 600 MG BID PO, 900 MG DAILY PO, 600 MG BID PO Propranolol Klonopin Saw Palmetto 22-Aug-2005 Page: 230 10:48 AM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Enzymatic Therapy Date:07/06/00ISR Number: 3525927-4Report Type:Periodic Age:38 YR Gender:Female I/FU:I Outcome Dose Other C Company Report #LBID00299000674 PT Report Source Product Role Manufacturer Route Abdominal Pain Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG TID PO Librax Mellaril Melatonin Date:07/06/00ISR Number: 3525929-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other C C C Company Report #LBID00299000828 PT Report Source Product Role Manufacturer Route Electroencephalogram Abnormal Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG BID PO Sleep Disorder Date:07/06/00ISR Number: 3525931-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00299001021 PT Report Source Product Role Manufacturer Route Oedema Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Manufacturer Route Duration DAILY PO Company Representative Date:07/06/00ISR Number: 3525944-4Report Type:Periodic Age:47 YR Gender:Male I/FU:I Outcome Dose PT Duration Company Report #LBID00299001086 Report Source Product Role Other Convulsion Health Professional Lithobid PS Solvay Pharmaceuticals ORAL DAILY PO Buspar (Buspirone Hydrochloride) Zoloft (Sertraline Hydrochloride) Date:07/06/00ISR Number: 3525947-XReport Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other C C Company Report #LBID00299001087 PT Report Source Product Role Manufacturer Route Hostility Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY PO Date:07/06/00ISR Number: 3525951-1Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00299001129 PT Report Source Product Role Manufacturer Route Anorgasmia Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration DAILY PO Company Representative 22-Aug-2005 Page: 231 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/00ISR Number: 3525962-6Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00299001131 PT Report Source Product Role Manufacturer Route Abdominal Pain Diarrhoea Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration DAILY PO Dry Mouth Date:07/06/00ISR Number: 3525964-XReport Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00299001175 PT Report Source Product Role Manufacturer Route Pruritus Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration PO Date:07/06/00ISR Number: 3525966-3Report Type:Periodic Age:37 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00299001184 PT Report Source Product Role Manufacturer Route Vomiting Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration DAILY PO Luvox (Fluvoxamine Maleate) SS PO Ativan (Lorazepam) Ambien (Zolpidem Tartrate) Navane (Tiotixene) Cogentin (Benzatropine Mesilate) Date:07/06/00ISR Number: 3525969-9Report Type:Periodic Age:46 YR Gender:Female I/FU:I Company Report #LBID00299001193 C C C C ORAL Outcome Dose Other PT Report Source Product Role Manufacturer Route Pain Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 600 MG BID PO Elavil (Amitriptuline Hydrochloride) Tegretol (Carbamazepine) Prozac (Fluoxetine Hydrochloride) Synthroid (Levothyroxine Sodium) Klonopin (Clonazepam) Date:07/06/00ISR Number: 3525973-0Report Type:Periodic Age:30 YR Gender:Female I/FU:I Outcome Dose Other C C C C Company Report #LBID00299001320 PT Report Source Product Role Manufacturer Route Tremor Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY PO Anafranil 22-Aug-2005 Page: 232 C 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clomipramine Hydrochloride) Synthroid (Levothyroxine Sodium) Date:07/06/00ISR Number: 3525974-2Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other C C Company Report #LBID00299001327 PT Report Source Product Role Manufacturer Route Drug Level Above Therapeutic Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Company Representative Lamictal (Lamotrigine) Duration DAILY PO Date:07/06/00ISR Number: 3525976-6Report Type:Periodic Age:13 YR Gender:Male I/FU:I Outcome Dose Other C Company Report #LBID00299001353 PT Report Source Product Role Manufacturer Route Paraesthesia Consumer Lithobid PS Solvay Pharmaceuticals ORAL Manufacturer Route Duration 300 MG BID PO Adderall (Dexamphetamine Sulphate; Deamphetamine Saccharate; Tenex (Guanfacine Hydrochloride) Zoloft (Sertraline Hydrochloride) Claritin (Loratadine) Date:07/06/00ISR Number: 3525978-XReport Type:Periodic Age: Gender:Female I/FU:I Outcome Dose PT Duration C C C C Company Report #LBID00299001477 Report Source Product Role Other Laryngospasm Health Professional Lithobid PS Solvay Pharmaceuticals ORAL DAILY PO Date:07/06/00ISR Number: 3525980-8Report Type:Periodic Age:57 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00299001635 PT Report Source Product Role Manufacturer Route Pollakiuria Weight Increased Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY PO Ditropan (Oxybutrin) Risperdal (Risperidone) Meridia () 22-Aug-2005 Page: 233 10:48 AM C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/00ISR Number: 3525982-1Report Type:Periodic Age:14 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00299001669 PT Report Source Product Role Manufacturer Route Headache Nausea Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 1500 MG DAILY Vomiting PO Risperdal (Riperidone) Date:07/06/00ISR Number: 3525983-3Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other C Company Report #LBID00299001822 PT Report Source Product Role Manufacturer Route Drug Interaction Drug Level Above Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Therapeutic Company Duration 1800 MG DAILY PO Representative Date:07/06/00ISR Number: 3525985-7Report Type:Periodic Age:35 YR Gender:Male I/FU:I Outcome Dose Other Vioxx (Vioxx) C Company Report #LBID00299001970 PT Report Source Product Role Manufacturer Route Diarrhoea Headache Consumer Lithobid PS Solvay Pharmaceuticals ORAL Route Duration 300 MG BID PO Mania Date:07/06/00ISR Number: 3525988-2Report Type:Periodic Age:10 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00299002038 PT Report Source Product Role Manufacturer Agitation Consumer Lithobid PS Solvay Duration Insomnia Pharmaceuticals ORAL Route 300 MG BID PO Tenex (Guanfacine Hydrochloride) Benadryl (Diphenhydramine Hydrochloride) Date:07/06/00ISR Number: 3525989-4Report Type:Periodic Age:60 YR Gender:Female I/FU:I Outcome Dose Other C C Company Report #LBID00299002141 PT Report Source Product Role Manufacturer Hyperkalaemia Health Professional Lithobid PS Solvay Pharmaceuticals Company Representative Ativan (Lorazepam) C Duration DAILY Date:07/06/00ISR Number: 3525990-0Report Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Visual Disturbance Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 600 MG DAILY PO 22-Aug-2005 Page: 234 Company Report #LBID00299002190 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/00ISR Number: 3525994-8Report Type:Periodic Age:51 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00299002192 PT Report Source Product Role Manufacturer Route Dry Mouth Thirst Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Route Duration 300 MG BID PO Date:07/07/00ISR Number: 3526587-9Report Type:Expedited (15-DaCompany Report #HQ8154405JUL2000 Age:1 DY Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Benign Congenital Initial or Prolonged Hypotonia TRANSPLACENTAL 25 MG, Complications Of Maternal TRANSPLACENTA Exposure To Therapeutic L 9 MON Drugs Drug Withdrawal Syndrome Neonatal TRANSPLACENTAL TRANSPLACENTA Feeding Problem In L Newborn Hyperreflexia Opisthotonus Tachypnoea TRANSPLACENTAL TRANSPLACENTA Thrombocytopenia Neonatal L Report Source Product Role Manufacturer Health Professional Effexor PS Wyeth Ayerst Laboratories Inc Anafranil (Clomipramine Hydrochloride) SS Other Lithium (Lithium) Ludiomil (Maprotiline Hydrochloride) SS C Date:07/10/00ISR Number: 3526775-1Report Type:Expedited (15-DaCompany Report #00CH-10028 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Benign Congenital Initial or Prolonged Hypotonia TRANSPLACENTAL DAILY, Report Source Product Role Manufacturer Foreign Health Anafranil PS Novartis Pharmaceuticals Corp Route Complications Of Maternal Professional Exposure To Therapeutic Other TRANSPLACENTA L TRANSPLACENTAL Drugs TRANSPLACENTA Feeding Problem In Lithium Carbonate SS Newborn Hyperreflexia Neonatal Disorder TRANSPLACENTA Opisthotonus Ludiomil (Maprotiline Hydrochloride) SS Psychomotor Hyperactivity Tachypnoea TRANSPLACENTA Thrombocytopenia Effexor (Venlafaxine) SS L TRANSPLACENTAL L TRANSPLACENTAL L Date:07/10/00ISR Number: 3527274-3Report Type:Expedited (15-DaCompany Report #00HQ-10282 Age:42 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 235 10:48 AM PT Coordination Abnormal Diarrhoea Dizziness Drug Interaction Drug Level Above Therapeutic Electrocardiogram Normal Electrocardiogram T Wave Inversion Fall Grand Mal Convulsion Haemodialysis FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Hypokalaemia Leukocytosis Loss Of Consciousness Report Source Product Role Manufacturer Sedation Sinus Arrhythmia Foreign Literature Tegretol PS Novartis Pharmaceuticals Corp Sinus Bradycardia Therapeutic Agent Health Professional Lithium (Lithium Carbonate) SS Toxicity Tremor Other Trihexyphenidyl Trazodone Bethanechol Chloride Clonazepam Moperone Hydrochlori C C C C C Route Duration 400 MG DAILY 900 MG DAILY Date:07/10/00ISR Number: 3578116-1Report Type:Periodic Age:53 YR Gender:Female I/FU:I Outcome Dose Company Report #USA013191 PT Report Source Product Role Manufacturer Route Anxiety Confusional State Consumer Other Meridia PS Knoll Pharmaceutical Co Sub Basf Corp ORAL Duration 10 MG OD PO Depression Lithium SS ORAL Lithium SS ORAL Neurontin Ambien Calcium Vitamin E Rose Hips Evista C C C C C C 450 MG NOCTE Dry Mouth PO High Density Lipoprotein 225 MG MANE Decreased PO Hypercholesterolaemia Insomnia Low Density Lipoprotein Increased Nervousness Restlessness Tremor Date:07/11/00ISR Number: 3527488-2Report Type:Expedited (15-DaCompany Report #239099 Age:59 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 120 MG 3 PER PT Report Source Product Role Manufacturer Route Infection Lymphoedema Foreign Health Xenical PS Hoffmann La Roche Inc ORAL Professional DAY ORAL Priadel (Lithium Carbonate Or Lithium Citrate) 600 Mg SS ORAL 600 MG 1 PER DAY ORAL Date:07/13/00ISR Number: 3528924-8Report Type:Expedited (15-DaCompany Report #2000018615-1 Age:60 YR Gender:Male I/FU:F Outcome Dose Death PT Report Source Product Role Manufacturer Route Nervous System Disorder Pulse Absent Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Duration 1125 MG, ORAL 3 DAY Respiratory Arrest Sedation 22-Aug-2005 Page: 236 10:48 AM Amaryl (Glimepirid) Heparin Orfiril (Valproat) Pirenzepin (Pirenzepin) Risperdal (Risperidon) Truxal (Chlorprothixen) C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Valium (Diazepam) C Date:07/13/00ISR Number: 3528928-5Report Type:Expedited (15-DaCompany Report #2000019161-1 Age:32 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Bradycardia Foetal Complications Of Maternal Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Duration 1350 MG, ORAL Exposure To Therapeutic Drugs Intra-Uterine Death Multiple Congenital Abnormalities Unwanted Pregnancy Gladem (Sertraline Hydrochloride) Saroten (Amitriptyline Hydrochloride) C C Date:07/13/00ISR Number: 3528959-5Report Type:Expedited (15-DaCompany Report #HQ8422112JUL2000 Age:53 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Asthenia Dizziness Consumer Effexor PS Wyeth Ayerst Laboratories Inc ORAL Duration 150 MG DAILY Drug Interaction Hypotension 4 Alcohol (Ethanol) Lithium (Lithium) SS SS ORAL ORAL DAY Malaise Nervous System Disorder Serotonin Syndrome Tremor Date:07/13/00ISR Number: 3531605-8Report Type:Expedited (15-DaCompany Report #2000-06-0664 Age:56 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 1000 MG QD PT Report Source Product Role Apathy Foreign Camcolit Tablets PS Manufacturer Route ORAL Initial or Prolonged ORAL Dehydration Other Diarrhoea Furosemide Tablets SS Drug Toxicity Sedation Intron A (Interferon Alfa-2b Recombinant) Soluble Powder SS 40 MG QD ORAL SUBCUTANEOUS 15 MU QD SUBCUTANEOUS Cardura Tablets Metformin Hydrochloride Tablets Zocor Tablets Date:07/14/00ISR Number: 3530011-XReport Type:Expedited (15-DaCompany Report #2000010163-1 Age:66 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 237 10:48 AM PT Aggression Agitation Asthenia Blood Creatinine Increased Blood Urea Decreased Coma Confusional State C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Cough Cyanosis Diabetes Mellitus Report Source Product Role Manufacturer Route Inadequate Control Drug Level Above Consumer Health Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Therapeutic Drug Toxicity Dysphagia Encephalopathy Haematocrit Decreased Haemoglobin Decreased Hypertension Hypotension Jaundice Malnutrition Muscle Rigidity Oliguria Pco2 Decreased Pneumonia Pyrexia Respiratory Failure Restlessness Retching Road Traffic Accident Speech Disorder Sputum Abnormal Tachypnoea Tremor Urinary Incontinence Professional Navane (Thiothixene) Lotensin (Benazepril) Naproxen Bactrim (Sulfamethoxzole/Rim ethoprim Insulin Depakote (Divalrpoex Sodium Zestril Risperdal Aspirin Iron Tegretol Keflex Duration ORAL Date:07/18/00ISR Number: 3531298-XReport Type:Expedited (15-DaCompany Report #2000015366-1 Age:52 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged Other Required Intervention to Prevent Permanent Impairment/Damage PT Arthralgia Asthenia Bone Pain Carpal Tunnel Syndrome Cerebellar Syndrome Cerebral Ischaemia Cerebrovascular Accident Choking Communication Disorder C C C C C C C C C C C C Coordination Abnormal Dehydration Depression Difficulty In Walking Dysarthria Encephalopathy Faecal Incontinence Fall Feeling Abnormal Gait Disturbance Hypovolaemia Laboratory Test Abnormal Motor Dysfunction Movement Disorder Muscular Weakness Neck Pain Overdose 22-Aug-2005 Page: 238 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Paraesthesia Renal Failure Renal Failure Acute Report Source Product Role Manufacturer Route Rhinorrhoea Urinary Incontinence Consumer Health Eskalith Cr PS Smithkline Beecham Pharmaceuticals ORAL Professional Eskalith SS Smithkline Beecham ORAL Depakote Synthroid Effexor Restoril C C C C Duration ORAL 10 YR 675 MILLIGRAMS 2.0 DAILY ORAL Date:07/19/00ISR Number: 3532073-2Report Type:Expedited (15-DaCompany Report #S00-FRA-00500-01 Age:51 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 40 MG QD PO PT Report Source Product Role Manufacturer Route Blood Phosphorus Decreased Foreign Health Celexa PS Forest Laboratories Inc ORAL Condition Aggravated Depression Hypercalcaemia Professional Other Hygroton (Chlortalidone) Tenormine (Atenolol) SS SS Hyperparathyroidism Nephrogenic Diabetes Tercian (Cyamemazine) SS Insipidus Polydipsia Psychogenic Teralithe (Lithium Carbonate) SS 100 MG QD 25 MG QD 1200 MG QD PO Psychotic Disorder Date:07/20/00ISR Number: 3532645-5Report Type:Expedited (15-DaCompany Report #PHBS2000CA04064 Age:23 YR Gender:Female I/FU:I ORAL Outcome Dose Other ORAL 12 PT Report Source Product Role Manufacturer Route Alanine Aminotransferase Increased Foreign Literature Clozaril PS Novartis Pharmaceuticals Corp ORAL Anorexia Health Lithium (Lithium) Aspartate Aminotransferase Increased Asthenia Blood Alkaline Phosphatase Increased Blood Creatinine Increased Eosinophilia Fatigue Influenza Like Illness Leukocytosis Nausea Pyrexia Sinus Tachycardia Vomiting Professional Other Duration 16 DAY DAY 22-Aug-2005 Page: 239 10:48 AM SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/00ISR Number: 3533960-1Report Type:Direct Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG TID PO Initial or Prolonged -LONG TERM PT Company Report # Report Source Product Role Lithium Co3 300mg PS ORAL Drug Level Above Lisinopril 5mg SS ORAL Therapeutic Gait Disturbance Mental Impairment Parkinsonism Haloperidol Benztropine Asa Hctz Levothyroxine C C C C C Akinesia Manufacturer Route Dialysis 5MG PO QD PO Date:07/24/00ISR Number: 3534842-1Report Type:Expedited (15-DaCompany Report #2000020093-1 Age:63 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Body Temperature Decreased Foreign Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Route Bradycardia Hypotension Intentional Misuse Sedation Tremor Vomiting Atenolol Efexor (Venlafaxine) Thioridazine C C C Date:07/25/00ISR Number: 3534900-1Report Type:Expedited (15-DaCompany Report #2000AP03298 Age:63 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 350 MG ONCE 1350 MG ONCE PT Report Source Product Role Manufacturer Body Temperature Decreased Foreign Health Tenormin PS Astrazeneca Pharmaceuticals Lp Bradycardia Professional Efexor SS ORAL Hypotension Other PO Overdose Lithium SS Sedation Lithium SS Thioridazine SS Thioridazine SS 2800 MG ORAL 2800 MG DAILY Tremor PO Vomiting 525 MG ORAL 525 MG DAILY PO Date:07/25/00ISR Number: 3535280-8Report Type:Expedited (15-DaCompany Report #PHBS2000FR03434 Age:25 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 400 MG/DAY, Initial or Prolonged ORAL Disability PT Report Source Product Role Manufacturer Route Asthenia Cardiac Failure Foreign Health Clozaril PS Novartis Pharmaceuticals Corp ORAL Congestive Professional Cardiomyopathy Myocarditis Pyrexia Other Teralithe (Lithium Carbonate) (Lithium Carbonate) SS Depakine Largactil Tranxene Kaleroid C C C C 600 MG/DAY, ORAL 22-Aug-2005 Page: 240 1 YR 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/00ISR Number: 3536218-XReport Type:Expedited (15-DaCompany Report #A025655 Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 750.00 MG Initial or Prolonged TOTAL:DAILY:O PT Report Source Blood Urea Increased Foreign Confusional State Literature Coordination Abnormal Health Delirium Professional Product Role Manufacturer Route Lithane PS Pfizer Inc ORAL Valsartan SS ORAL Quetiapine SS ORAL L-Tryptophan Lorazepam Glyburide Conjugated Estrogens C C C C RAL 80.00 MG Drug Interaction TOTAL:DAILY:O Drug Level Above RAL Therapeutic 50.00 MG Grandiosity TOTAL:DAILY:O Mania RAL Medication Error Sedation Date:07/28/00ISR Number: 3537781-5Report Type:Expedited (15-DaCompany Report #LBID00200005232 Age:76 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Accidental Overdose Agitation Literature Health Lithobid PS Solvay Pharmaceuticals ORAL Anxiety Professional Duration 900 MG QD PO, 600 MG QD PO Cognitive Disorder Drug Level Above Therapeutic Dysphoria Feeling Of Despair Thinking Abnormal Date:07/28/00ISR Number: 3537782-7Report Type:Expedited (15-DaCompany Report #LBID00200005226 Age:86 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG QD PO PT Report Source Product Role Manufacturer Route Asthenia Hip Fracture Literature Health Lithobid PS Solvay Pharmaceuticals ORAL Hypotonia Movement Disorder Tremor Professional Levothyroxine (Levothyroxine) Clopidogrel (Clopidogrel) Diltiazem (Diltiazem) Fosinopril (Fosinopril) Insulin (Insulin) Vitamins (Vitamins) Laxative (Laxative) Oxycodone (Oxycodone) Date:07/31/00ISR Number: 3538613-1Report Type:Expedited (15-DaCompany Report #WAES 00060222 Age:68 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 241 10:48 AM PT Confusional State Coordination Abnormal Drug Interaction C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysarthria Speech Disorder Tremor Dose Report Source Product Role Manufacturer Route Health Professional Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL Duration 12.5 MG/DAILY/PO Lithium Carbonate SS Allegra Fosamax Klonopin Levoxyl Calcium Supplement (Composition Nortriptyline) Thyroid Nortriptyline C C C C ORAL 600 MG/DAILY/PO C C C Date:08/03/00ISR Number: 3541059-3Report Type:Expedited (15-DaCompany Report #2000022699-1 Age:66 YR Gender:Male I/FU:I Outcome Dose Duration Death Life-Threatening 2.0 DAILY Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Manufacturer Route Cardiac Arrest Drug Level Above Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Therapeutic Drug Toxicity Ranitidine Amitriptyline Prednisone Enoxaparine Aspirin (Acetylsalicylic Acid) Lisinopril C C C C C C Date:08/03/00ISR Number: 3541083-0Report Type:Expedited (15-DaCompany Report #00-0860 Age:45 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Abnormal Behaviour Blister Consumer Health Loxapine Succinate PS Watson Laboratories Inc ORAL Brain Damage Professional Cerebral Cyst Other Duration 30 MG; 60 MG; 40 MG; 30 MG; DAILY, ORAL Memory Impairment Mental Impairment Lithium Carbonate 300 Mg SS 300 MG PO AM; Peripheral 600 MG PM 10 YR Neuroepithelioma Rhinorrhoea Sleep Disorder Thrombocytopenia Tremor 22-Aug-2005 Page: 242 10:48 AM Depakene Prolixin Clozapine Haldol Olanzapine Seizure Medication Antidepressant L-Tryptophan, Many Years Through Lithobid One-A-Day Vitamin 5 Hydroxytryptophan Vitamin C C C C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/00ISR Number: 3542745-1Report Type:Expedited (15-DaCompany Report #2000023069-1 Age:50 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Stevens-Johnson Syndrome Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals Erythromycin SS Route Duration Date:08/08/00ISR Number: 3544592-3Report Type:Direct Age:39 YR Gender:Female I/FU:I Outcome Dose Duration Other 200MG PO QHS Company Report # PT Report Source Product Role Agraphia Health Serzone 200mg Po Qhs PS Cognitive Disorder Professional Lithium Carbonate SS Manufacturer Route ORAL 900MG BID Coordination Abnormal Disturbance In Attention Dysphemia Dystonia Hallucination Muscular Weakness Date:08/08/00ISR Number: 3544665-5Report Type:Direct Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG PO TID Company Report # PT Report Source Product Role Manufacturer Route Asthenia Fall Health Professional Lithium 300mg (Roxanne) PS Roxanne ORAL Haloperodol Aspirin Ec Phenytoin Bactrim Ds Fluconazole Clotrimazole Lotion Betamethasone Oint Theravite C C C C C C C C Vision Blurred Date:08/09/00ISR Number: 3548405-5Report Type:Periodic Age:65 YR Gender:Male I/FU:I Outcome Dose Other Company Report #1357422A PT Report Source Product Role Manufacturer Route Abnormal Dreams Hallucination Foreign Consumer Tylenol PS Mcneil Consumer Products Co Div Mcneilab Inc ORAL Duration 1000 MG, Q4H, PO 8 DAY Lithium SS Diabeta Lipidil C C 1200 MG/DAY, PO Date:08/10/00ISR Number: 3548690-XReport Type:Expedited (15-DaCompany Report #001-0719-M0000140 Age:63 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 243 10:48 AM PT Blood Electrolytes Decreased Drug Interaction Drug Level Above Therapeutic ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyponatraemia Insomnia Oral Intake Reduced Dose Report Source Product Role Manufacturer Route Consumer Lopid PS Parke Davis Pharmaceuticals Ltd ORAL Duration 600 MG (DAILY), PER ORAL Eskalith (Lithium Carbonate) SS ORAL 450 MG (DAILY), PER ORAL Glucophage (Metformin Hydrochloride) Prempro (Medroxyprogesterone Acetate, Estrogens Conjugated) Benadryl (Diphenhydramine Hydrochloride) Trazodone SS SS C C Date:08/14/00ISR Number: 3550378-6Report Type:Expedited (15-DaCompany Report #2000022369-1 Age:45 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1350 MG, ORAL 3 YR PT Report Source Product Role Manufacturer Route Anaemia Megaloblastic Biopsy Bone Marrow Foreign Health Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Abnormal Macrocytosis Professional Other Stangyl (Trimipramine Maleate) Zoloft (Sertraline Hydrochloride) C C Date:08/14/00ISR Number: 3550459-7Report Type:Expedited (15-DaCompany Report #2000015366-1 Age:52 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged Other Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 244 10:48 AM PT Abdominal Pain Asthenia Back Pain Balance Disorder Bipolar Disorder Chills Choking Confusional State Constipation Coordination Abnormal Decreased Activity Depressed Level Of Consciousness Depression Diabetes Insipidus Dialysis Difficulty In Walking Disorientation Disturbance In Attention Drug Toxicity FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose ORAL Dysarthria Dysphagia Electrocardiogram St Report Source Product Role Manufacturer Route Segment Abnormal Encephalopathy Consumer Health Eskalith Cr PS Smithkline Beecham Pharmaceuticals ORAL Faecal Incontinence Professional Eskalith Duration 10 YR SS ORAL 675 Fall MILLIGRAMS Hyperglycaemia 2.0 DAILY Hypernatraemia ORAL Hypokalaemia Infection Medication Error Memory Impairment Metabolic Encephalopathy Paranoia Pneumonia Aspiration Psychotic Disorder Pyrexia Renal Failure Acute Rhinorrhoea Sepsis Tremor Urinary Incontinence Urinary Retention Verbigeration Vitamin B12 Deficiency Date:08/17/00ISR Number: 3552006-2Report Type:Direct Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 300MG CAPS PO Hospitalization TID Initial or Prolonged PT Dialysis Depakote (Valproate Semisodium) Synthroid (Levothyroxine) Effexor (Venlafaxine Hydrochloride) Restoril C C C C Company Report # Report Source Product Role Lithium 300mg Caps PS Tegretol Haldol Lisinopril C C C Drug Level Above Therapeutic Drug Toxicity Emotional Distress Manufacturer Route ORAL Gastrointestinal Disorder Tremor Date:08/21/00ISR Number: 3554398-7Report Type:Expedited (15-DaCompany Report #A028449 Age: Gender:Female I/FU:I Outcome Dose Duration Disability Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Amnesia Depression Mental Disorder Panic Attack Weight Increased Consumer Sinequan PS Pfizer Laboratories Div Pfizer Inc Sertraline Lithium Prozac Lotensin Klonopin SS SS SS C C Date:08/21/00ISR Number: 3554447-6Report Type:Expedited (15-DaCompany Report #2000023739-1 Age:71 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 245 10:48 AM PT Blood Creatinine Increased Blood Lactate Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Dehydrogenase Increased Blood Urea Increased Coma Computerised Tomogram Report Source Product Role Manufacturer Abnormal Coordination Abnormal Literature Health Eskalith PS Smithkline Beecham Pharmaceuticals Csf Test Abnormal Professional Manufacturer Route Duration 750 MILLIGRAMS Dehydration Dyskinesia Escherichia Sepsis Fall Gait Disturbance Hepatic Enzyme Increased Hypernatraemia Hyperparathyroidism Hyperpyrexia Hyporeflexia Leukocytosis Loss Of Consciousness Nephrogenic Diabetes Insipidus Neutrophilia Peripheral Sensory Neuropathy Polyuria Psychiatric Symptom Pyrexia Pyuria Quadriplegia Renal Tubular Disorder Sedation Sensory Disturbance Tachycardia Tachypnoea Urinary Incontinence Date:08/22/00ISR Number: 3555728-2Report Type:Expedited (15-DaCompany Report #EWC000807564 Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 900 MG/DAY PT Report Source Product Role Breast Pain Foreign Lithium PS Route Initial or Prolonged 20 MG/DAY Other Bundle Branch Block Right Study Olanzapine SS Dyspnoea Haematocrit Decreased Haemoglobin Decreased Mean Cell Volume Decreased Microcytic Anaemia Health Professional Other Lorazepam C Date:08/23/00ISR Number: 3556308-5Report Type:Direct Age:30 YR Gender:Male I/FU:I Outcome Dose Duration Other 300 MG PO BID 22-Aug-2005 Page: 246 10:48 AM PT Priapism Company Report # Report Source Product Role Lithium Carbonate PS Paroxetine Hydroxyzine Sumatriptan Alprazolam C C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/00ISR Number: 3556457-1Report Type:Expedited (15-DaCompany Report #L00-TWN-01201-01 Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged 200 MG BID PO PT Report Source Product Role Manufacturer Route Blood Creatinine Increased Convulsion Foreign Literature Health Carbamazepine PS Inwood Laboratories Inc Sub Forest Laboratories Inc ORAL Diarrhoea Professional Lithium SS Dizziness Drug Level Above Therapeutic Drug Level Below Therapeutic Electrocardiogram Abnormal Electrocardiogram Qt Corrected Interval Prolonged Electrocardiogram Qt Prolonged Electrocardiogram T Wave Inversion Fall Hypokalaemia Leukocytosis Loss Of Consciousness Sedation Sinus Arrest Sinus Arrhythmia Sinus Bradycardia Other Clonazepam Trazadone Moperone Bethanechol Trihexyphenidyl C C C C C ORAL 900 MG QD PO Date:08/24/00ISR Number: 3557700-5Report Type:Expedited (15-DaCompany Report #10498152 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL 400 MG, 1/1 PT Report Source Product Role Manufacturer Route Drug Interaction Drug Level Above Foreign Health Avapro PS Sanofi Synthelabo Inc ORAL Therapeutic Professional Other Priadel (Lithium Carbonate) SS ORAL DAY ORAL Date:08/24/00ISR Number: 3566371-3Report Type:Direct Age:14 YR Gender:Male I/FU:I Outcome Dose Company Report # PT Report Source Product Role Manufacturer Route Blood Thyroid Stimulating Health Lithium PS ORAL Hormone Increased Professional Thorazine SS ORAL Condition Aggravated Depakote SS ORAL Hypercholesterolaemia Seroquel SS ORAL Hypertriglyceridaemia Depakote SS ORAL Zyprexa SS ORAL Ritalin SS Tenex C Duration 600 MG PO BID 200 MG PO QID 500 MG PO BID 200 MG PO BID 250-750 MG PO 5MG PO HS 20 MG PO TID 22-Aug-2005 Page: 247 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/00ISR Number: 3558701-3Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Other 350MG/D-DIVID PT Company Report # Report Source Rash Macular Product Role Clozapine PS Lithium SS Cogentin Neurontin Lithium Prevacid C C C C Manufacturer Route Skin Hyperpigmentation ED ORAL 300MG PO TID Date:08/28/00ISR Number: 3560606-9Report Type:Expedited (15-DaCompany Report #2000024412-2 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Amoebic Dysentery Initial or Prolonged Benign Congenital TRANSPLACENTAL TRANSPLACENTA Hypotonia RY, Cardiac Murmur TRANSMAMMARY Complications Of Maternal Exposure To Therapeutic Drugs Cyanosis Neonatal Drug Level Above Therapeutic Electrocardiogram T Wave Inversion Hypoglycaemia Neonatal Hypothermia Insomnia Lethargy Pregnancy Report Source Product Role Manufacturer Literature Health Eskalith PS Smithkline Beecham Pharmaceuticals Chlorthalidone Thyroglobulin Secobarbital Chloramphenicol Iodochlorhydroxyquin C C C C C Professional Route Date:08/29/00ISR Number: 3561571-0Report Type:Direct Age:60 YR Gender:Male I/FU:I Outcome Dose Company Report # PT Report Source Product Role Asthenia Health Lithium Sr 450mg PS Dizziness Drug Level Above Therapeutic Gait Disturbance Professional Asa Lith Carb Sr Vpa Cogentin Chlorpramazine Glyburide Prazonin Simvastatin Fosinopril C C C C C C C C C 450 MG PO TID Date:08/29/00ISR Number: 3561792-7Report Type:Expedited (15-DaCompany Report #EWC000807564 Age:55 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 248 Manufacturer Route Duration 10:48 AM PT Breast Pain Bundle Branch Block Right Dyspnoea Haematocrit Decreased Mean Cell Volume Abnormal Microcytic Anaemia ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Embolism Dose UNKNOWN Report Source Product Role Foreign Lithium PS Olanzapine SS Lorazepam C Manufacturer Route Duration 900 MG DAY Study UNKNOWN Health UNKNOWN 20 MG DAY Professional UNKNOWN Other Date:08/30/00ISR Number: 3562226-9Report Type:Expedited (15-DaCompany Report #HQ0130422AUG2000 Age:17 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Athetosis Cerebellar Syndrome Coma Literature Artane PS Lederle Laboratories Div American Cyanamid Co ORAL 2 MG FOUR Coordination Abnormal TIMES DAILY Dysarthria ORAL Dysphagia Chlorpromazine SS Clozapine SS ORAL Lithium SS ORAL 50 MG AS Dystonia NEEDED Electroencephalogram 25 MG DAILY Abnormal INCREASED TO Encephalopathy 100 MG TWICE Enuresis DAILY Fall DECREASED TO Grand Mal Convulsion 300 MG FOUR Hypotension TIMES DAILY Hypotonia ORAL Lethargy Movement Disorder Neuroleptic Malignant Syndrome Orthostatic Hypotension Pyrexia Sedation Tachycardia Tremor Vomiting Aspirin "Bayer" Ceftriaxone Haloperidol C C C Date:09/01/00ISR Number: 3564128-0Report Type:Expedited (15-DaCompany Report #243169 Age:45 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 3 DOSE FORM PT Report Source Product Role Manufacturer Route Blood Thyroid Stimulating Hormone Decreased Foreign Other Valium PS Hoffmann La Roche Inc ORAL Dehydration DAILY, ORAL Hypernatraemia Hyperthyroidism Lithium Microsol (Lithium Bromide) SS ORAL Hypotension Zyprexa (Olanzapine) SS ORAL Tercian (Cyamemazine) 40 Mg/Ml SS ORAL ORAL 1 DOSE FORM Nephrogenic Diabetes DAILY, ORAL Insipidus Polydipsia Polyuria 25 MG 3 PER DAY ORAL 22-Aug-2005 Page: 249 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/08/00ISR Number: 3568965-8Report Type:Expedited (15-DaCompany Report #2000023526-1 Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE Other PT Report Source Product Role Manufacturer Route Amyotrophic Lateral Sclerosis Health Professional Eskalith Cr PS Smithkline Beecham Pharmaceuticals ORAL Route Condition Aggravated Drug Ineffective Headache Loss Of Libido Mania Polydipsia Tremor Haldol (Haloperidol) Cogentin (Benztropine Mesylate) Dalmane (Flurazepam Hydrochloride) Date:09/08/00ISR Number: 3573478-3Report Type:Periodic Age:27 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 C C C Company Report #2000026052-1 PT Report Source Product Role Manufacturer Drug Interaction Drug Toxicity Literature Lithium Smithkline Beecham PS Smithkline Beecham Lithium Smithkline Beecham SS Smithkline Beecham Lithium Smithkline Beecham SS Smithkline Beecham MILLIGRAMS 2.0 DAILY 600 MILLIGRAMS 1.0 DAILY 900 MILLIGRAMS 1.0 DAILY Sulindac Nefazodone Fluphenazine C C Decanoate Lorazepam Gemfibrozil Date:09/08/00ISR Number: 3573484-9Report Type:Periodic Age:23 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600-900 C C C Company Report #2000026032-1 PT Report Source Product Role Manufacturer Drug Interaction Drug Toxicity Literature Lithium Smithkline Beecham PS Smithkline Beecham Sulindac Divalproex Sodium Olanzapine Tetracycline C C C C MILLIGRAMS 1.0 DAILY (SEE NEXT PAGE) 4 MON Date:09/13/00ISR Number: 3571247-1Report Type:Expedited (15-DaCompany Report #00P-083-0096941-00(1) Age:33 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 250 10:48 AM PT Fall Spinal Fracture Report Source Foreign Health Professional Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Dose Product Role Manufacturer Route Ferrograd (Fero-Gradumet Filmtab) (Ferrous Sulfate) PS ORAL Zomig Rapimeld SS ORAL Lithium Carbonate (Lithium Carbonate) SS ORAL Paroxetine (Par0xetine) SS ORAL Duration 525 MG, 1 IN 1 D, PER ORAL 5 MG, 1 IN 1 D, PER ORAL 600 MG, 1 IN 1 D, PER 0RAL 20 MG, 1 IN 1 D, PER ORAL Date:09/13/00ISR Number: 3574873-9Report Type:Expedited (15-DaCompany Report #2000026382-1 Age:66 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Amnesia Clonic Convulsion Cognitive Disorder Coma Dementia Disorientation Drug Level Above Therapeutic Drug Toxicity Electroencephalogram Abnormal Encephalopathy Extrapyramidal Disorder Hyperreflexia Literature Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals Route Parkinsonism Pulmonary Congestion Respiratory Distress Speech Disorder Tremor Date:09/14/00ISR Number: 3570958-1Report Type:Direct Age:56 YR Gender:Female I/FU:I Outcome Dose Duration Death 300MG PO Q 8 INTRAVENOUS PT Dyspnoea Hyperpyrexia 1.25MG IV Q4 Renal Failure Company Report # Report Source Product Role Lithium PS Droperidol SS PRN Respiratory Failure Date:09/14/00ISR Number: 3571678-XReport Type:Expedited (15-DaCompany Report #239346 Age:60 YR Gender:Male I/FU:F Outcome Death 22-Aug-2005 Page: 251 PT Diabetes Mellitus Drug Level Above Therapeutic Mania 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulse Absent Respiratory Disorder Stupor Dose Report Source Product Role Manufacturer Route Foreign Study Valium PS Hoffmann La Roche Inc ORAL Duration 30 MG DAILY Health ORAL Professional INTRATUMOR Valium (Diazepam) SS Quilonum Retard (Lithium Carbonate) SS Orfiril (Valproate Sodium) SS Truxal (Chlorprothixene) SS Truxal (Chlorprothixene) SS Truxal (Chlorprothixene) SS Risperdal (Risperidone) SS 10 MG DAILY INTRAVENOUS 1350 MG DAILY 600 MG DAILY ORAL 150 MG DAILY ORAL INTRAVENOUS 100 MG DAILY INTRAVENOUS 100 MG DAILY ORAL 6 MG DAILY Amaryl(Glimepiride) Pirenzepine (Pirenzepine Hydrochloride) Heparin (Heparin Sodium) C C C ORAL Date:09/15/00ISR Number: 3572762-7Report Type:Expedited (15-DaCompany Report #LBID00200005688 Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 800 MG DAILY 22-Aug-2005 Page: 252 10:48 AM PT Report Source Product Role Manufacturer Alpha 2 Globulin Increased Foreign Literature Lithobid PS Solvay Pharmaceuticals Anaemia Blood Urea Increased Cerebellar Ataxia Diarrhoea Drug Level Above Therapeutic Dysarthria Glomerulonephritis Proliferative Haemoglobin Decreased Hypercholesterolaemia Hypoproteinaemia Lethargy Leukopenia Oedema Pleural Effusion Proteinuria Health Professional Other Haloperidol (Haloperidol) Doxepin (Doxepin) Biperiden (Biperiden) C C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/18/00ISR Number: 3573051-7Report Type:Direct Age:35 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Balance Disorder Confusional State Dehydration Drug Level Above Therapeutic Dysarthria Haemodialysis Date:09/18/00ISR Number: 3573108-0Report Type:Direct Age:45 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 500MG 2X/DIEM 6 MON Initial or Prolonged Disability 1500MG 2X Required DIEM ORAL 4 MON Intervention to Prevent Permanent Impairment/Damage Company Report # PT Product Role Lithium PS Role Acne Alopecia Depakote, 1000 Mg Per Diem PS Depression Drug Withdrawal Syndrome Lithium-1500 Mg Per Diem SS Hallucination, Gustatory Increased Appetite Insomnia Judgement Impaired Lethargy Mania Muscle Spasms Myalgia Nervous System Disorder Obesity Psychotic Disorder Scar Suicidal Ideation Tic Tremor Visual Acuity Reduced Weight Increased Route Manufacturer Route Company Report # Product Epistaxis Manufacturer Report Source ORAL Date:09/18/00ISR Number: 3574948-4Report Type:Expedited (15-DaCompany Report #2000026865-1 Age:68 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 253 10:48 AM PT Aggression Blood Calcium Increased Blood Chloride Decreased Blood Creatinine Increased Blood Parathyroid Hormone Increased Blood Thyroid Stimulating Hormone Decreased Calcium Ionised Increased Confusional State Coordination Abnormal Delirium Disinhibition Drug Toxicity Euthyroid Sick Syndrome Feeling Jittery FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Flight Of Ideas Hypercalcaemia Hypernatraemia Report Source Product Role Manufacturer Hyperreflexia Hyperthyroidism Literature Health Eskalith PS Smithkline Beecham Pharmaceuticals Hyponatraemia Professional Carbamazepine Citalopram Simvastatin Temazepam Thioridazine C C C C C Route Duration 750 MILLIGRAMS Mania Nephrogenic Diabetes Insipidus Pressure Of Speech Speech Disorder Thyroiditis Chronic Thyroxine Increased Tri-Iodothyronine Increased Date:09/18/00ISR Number: 3574949-6Report Type:Expedited (15-DaCompany Report #2000026969-1 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Overdose Literature Eskalith PS Smithkline Beecham Pharmaceuticals Alimemazine Benzodiazepines Venlafaxine C C C Route Duration Date:09/18/00ISR Number: 3575039-9Report Type:Expedited (15-DaCompany Report #2000026461-1 Age:24 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL Other PT Report Source Product Role Manufacturer Route Abdominal Pain Agitation Literature Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Cerebellar Atrophy Condition Aggravated Coordination Abnormal Depression Diarrhoea Maprotiline C Disorientation Drug Toxicity Dry Mouth Dysarthria Gait Disturbance Headache Intentional Misuse Stress Suicidal Ideation Suicide Attempt Tremor Vomiting Date:09/18/00ISR Number: 3575040-5Report Type:Expedited (15-DaCompany Report #2000026798-1 Age:34 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 254 10:48 AM PT Agitation Blood Bicarbonate Decreased Blood Creatinine FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Increased Blood Thyroid Stimulating Hormone Decreased Blood Urea Increased Report Source Product Role Manufacturer Clubbing Confusional State Literature Health Eskalith PS Smithkline Beecham Pharmaceuticals Dehydration Professional Diphenoxylate/Atropi ne Metoclopramide Paroxetine Thioridazine C C C C Duration 1500 MILLIGRAMS 10 YR Delirium Dermatitis Diarrhoea Drug Toxicity Extrasystoles Faecal Incontinence Haemodialysis Hyperglycaemia Hypernatraemia Hyperosmolar State Hyperreflexia Hyperthyroidism Hypertonia Hypochloraemia Hypokalaemia Hyponatraemia Hypothyroidism Implant Site Infection Iodine Uptake Increased Lid Lag Myopathy Nephrogenic Diabetes Insipidus Nervous System Disorder Polyuria Pyrexia Renal Impairment Renal Tubular Necrosis Sepsis Tachycardia Thyrotoxic Crisis Thyroxine Increased Tremor Tri-Iodothyronine Increased Urinary Incontinence Urinary Tract Infection Vomiting Route Date:09/18/00ISR Number: 3575041-7Report Type:Expedited (15-DaCompany Report #2000026922-1 Age:78 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Metabolic Disorder Renal Disorder Literature Health Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Professional Date:09/19/00ISR Number: 3574919-8Report Type:Expedited (15-DaCompany Report #00P-083-0096941-00 (1) Age:33 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 255 10:48 AM PT Fall Spinal Fracture Report Source Foreign Health FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Dose Product Role Manufacturer Route Ferrograd Tablets (Fero-Gradumet Filmtab) (Ferrous Sulfate) PS ORAL Zomig Rapimeld SS ORAL Lithium Carbonate (Lithium Carbonate) SS ORAL Paroxetine (Paroxetine) SS ORAL Duration 525 MG , 1 IN 1 D, PER ORAL 5 MG, 1 IN 1 D, PER ORAL; 2.5 MG 1 IN 1 D, PER ORAL 600 MG, 1 IN 1 D, PER ORAL 20 MG, 1 IN 1 D, PER ORAL Date:09/20/00ISR Number: 3575521-4Report Type:Expedited (15-DaCompany Report #LBID00200005755 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 750 MG DAILY PT Report Source Product Role Manufacturer Route Antibody Test Positive Electromyogram Abnormal Foreign Literature Lithobid PS Solvay Pharmaceuticals ORAL Fatigue Health Muscular Weakness Myasthenia Gravis Professional Other PO Benzodiazepine Carbamazepine (Carbamazepine) C C Date:09/20/00ISR Number: 3575733-XReport Type:Expedited (15-DaCompany Report #2000027172-1 Age:60 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Chronic Lymphocytic Leukaemia Leukocytosis Thrombocythaemia Foreign Health Professional Other Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Date:09/20/00ISR Number: 3575734-1Report Type:Expedited (15-DaCompany Report #2000018615-1 Age:60 YR Gender:Male I/FU:F Outcome Dose Death PT Report Source Product Role Manufacturer Route Diabetes Mellitus Drug Level Above Foreign Health Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Therapeutic Professional Nervous System Disorder Pulse Absent Respiratory Arrest Sedation Other Duration 1125 MILLIGRAMS 22-Aug-2005 Page: 256 3 DAY 10:48 AM Amaryl (Glimepirid) Heparin Orfiril (Valproat) Pirenzepin (Pirenzepin) Risperdal (Reisperidon) Truxal (Chlorprothixen) Valium (Diazepam) C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/00ISR Number: 3575803-6Report Type:Expedited (15-DaCompany Report #LBID00200005748 Age:63 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG TID PO PT Report Source Product Role Manufacturer Route Blood Creatine Phosphokinase Increased Literature Health Lithobid PS Solvay Pharmaceuticals ORAL Blood Creatinine Increased Blood Urea Increased Blunted Affect Decreased Activity Dementia Depressed Level Of Consciousness Disorientation Disturbance In Attention Hyperhidrosis Hypernatraemia Hypertension Judgement Impaired Leukocytosis Muscle Rigidity Myoglobinuria Neuroleptic Malignant Syndrome Pyrexia Sensory Disturbance Tachycardia Professional Amoxapine (Amoxapine) Lorazepam Benztropine Atenolol Verapamil SS C C C C Date:09/21/00ISR Number: 3576882-2Report Type:Expedited (15-DaCompany Report #LBID00200005776 Age:27 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG BID PT Report Source Product Role Manufacturer Route Drug Interaction Drug Level Above Literature Health Lithobid PS Solvay Pharmaceuticals ORAL Therapeutic Professional PO, 1500 MG DAILY PO Sulindac (Sulindac) 150 MG BID PO SS ORAL Gemfibrozil Nefazodone Fluphenazine Deconate Lorazepam C C C C Date:09/22/00ISR Number: 3576365-XReport Type:Expedited (15-DaCompany Report #245208 Age:68 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 25 DAY Initial or Prolonged 660 DAY 60 DAY 257 DAY PT Product Role Manufacturer Agitation Rivotril PS Roche Anxiety Silece SS Roche Depressed Level Of Limas SS Consciousness Lodopin SS Disorientation Drug Level Above Therapeutic Electroencephalogram Abnormal Therapeutic Agent Toxicity 22-Aug-2005 Page: 257 10:48 AM Report Source Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/00ISR Number: 3578319-6Report Type:Expedited (15-DaCompany Report #A031176 Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 800.00 MG Initial or Prolonged TOTAL:ORAL PT Report Source Product Role Manufacturer Route Anaemia Foreign Lithium Carbonate PS Pfizer Inc ORAL Blood Albumin Decreased Literature Blood Urea Decreased Cerebellar Ataxia Diarrhoea Drug Level Above Therapeutic Drug Toxicity Dysarthria Glomerulonephritis Proliferative Hypercholesterolaemia Lethargy Leukopenia Nephrotic Syndrome Oedema Pleural Effusion Proteinuria Red Blood Cell Count Abnormal Renal Impairment White Blood Cell Count Abnormal Health Professional Haloperidol Doxepin Biperiden C C C Date:09/22/00ISR Number: 3578847-3Report Type:Expedited (15-DaCompany Report #245208 Age:68 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 0.5 MG DAILY PT Report Source Product Role Manufacturer Route Agitation Anxiety Foreign Health Clonopin PS Hoffmann La Roche Inc ORAL Depressed Level Of Professional Consciousness Other ORAL 2 MG DAILY Disorientation ORAL Silece SS ORAL Drug Level Above Limas SS ORAL Lodopin SS ORAL 800 MG DAILY Therapeutic ORAL Electroencephalogram 25 MG DAILY Abnormal ORAL Therapeutic Agent Toxicity Date:09/25/00ISR Number: 3579360-XReport Type:Expedited (15-DaCompany Report #2000022369-1 Age:45 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1350 PT Report Source Product Role Manufacturer Route Anaemia Macrocytic Biopsy Bone Marrow Health Professional Eskalith Cr PS Smithkline Beecham Pharmaceuticals ORAL Abnormal MILLIGRAMS Hyperchromic Anaemia ORAL Macrocytosis 22-Aug-2005 Page: 258 10:48 AM Stangyl Vitamin B12 Zoloft C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/00ISR Number: 3579365-9Report Type:Expedited (15-DaCompany Report #DEU003143 Age:69 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 3 MG DAILY PO Initial or Prolonged 1000 MG DAILY PT Report Source Product Role Manufacturer Route Aggression Bipolar I Disorder Foreign Health Akineton PS Knoll Pharmaceutical Co ORAL Cerebellar Ataxia Professional Limas SS ORAL Condition Aggravated Other Lodopin SS ORAL Silece C PO Excitability 50 MG DAILY Insomnia PO Neuroleptic Malignant Syndrome Stupor Therapeutic Agent Toxicity Urinary Incontinence Date:09/25/00ISR Number: 3579463-XReport Type:Expedited (15-DaCompany Report #EWC000506839 Age:33 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 3600 MG/DAY Initial or Prolonged 7.5 MG/DAY PT Report Source Product Role Depression Foreign Lithium PS Mania Study Olanzapine SS Mood Altered Psychomotor Hyperactivity Suicide Attempt Health Professional Other Lorazepam C Manufacturer Route Route Date:09/25/00ISR Number: 3581811-1Report Type:Expedited (15-DaCompany Report #2000026922-1 Age:76 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization - PT Report Source Product Role Manufacturer Anxiety Literature Eskalith PS Smithkline Beecham Initial or Prolonged 250 MILLIGRAM Bipolar Disorder Health Blood Amylase Increased Professional ORAL Blood Creatinine Increased Blood Urea Increased Dehydration Depression Extrapyramidal Disorder Hypercalcaemia Hyperparathyroidism Hypothyroidism Lipase Increased Nephrogenic Diabetes Insipidus Polyuria Proteinuria Psychomotor Retardation Renal Failure Suicidal Ideation Urinary Incontinence Date:09/25/00ISR Number: 3583140-9Report Type:Expedited (15-DaCompany Report #2000-06-0664 Age:56 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 259 10:48 AM PT Apathy Dehydration Pharmaceuticals ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Drug Toxicity Sedation Dose Report Source Product Role Manufacturer Route Foreign Camcolit PS ORAL Furosemide Tablets SS ORAL Intron A (Interferon Alfa-2b Recombinant Soluble Powder) SS Cardura Tablets Metformin Zocor Tablets Artane Tablets Temazepam Capsules Trilafon C C C C C C Duration 1000 MG QD Other ORAL 40 MG QD ORAL SUBCUTANEOUS 15 MU QD SUBCUTANEOUS Date:09/27/00ISR Number: 3581293-XReport Type:Direct Age:56 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Confusional State Diabetes Insipidus Hypernatraemia Tremor Health Professional Lithium PS Date:09/28/00ISR Number: 3582576-XReport Type:Direct Age:65 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report # PT Athetosis Coordination Abnormal Dyskinesia Muscle Rigidity Tremor Manufacturer Route Manufacturer Route Company Report # Report Source Product Role Lithium PS Date:09/28/00ISR Number: 3582787-3Report Type:Direct Age:41 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Confusional State Drug Toxicity Company Report # Report Source Product Role Lithium Carbonate 300mg Cap Acetaminophen Guaifenesin Sertraline Hcl Valsartan Beclomethasone Benztropine Mesylate Thiothixene Hcl Atenolol PS C C C C C C C C Date:09/28/00ISR Number: 3584447-1Report Type:Expedited (15-DaCompany Report #8-99092-033A Age:62 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 260 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Dose PT Report Source Product Role Manufacturer Route Blood Lactate Dehydrogenase Increased Health Professional Effexor PS Wyeth Ayerst Laboratories Inc ORAL Duration SEE IMAGE, Coma ORAL 14 DAY Drug Interaction Electrocardiogram Alimemazine (Alimemazine SS ORAL Lithium (Lithium) SS ORAL Noctran 10 (Acepromazine/ Aceprometazine/ Clorazepate Dipotassium,) SS ORAL Imovane (Zopiclone) C SEE IMAGE, Abnormal ORAL 1 DAY Electrocardiogram Qrs SEE IMAGE, Complex Prolonged ORAL 1 DAY Hypotension Intentional Misuse Respiratory Depression Suicide Attempt Toxicologic Test Abnormal 300 MG, OVERDOSE AMOUNT, ORAL 1 DAY Date:09/28/00ISR Number: 3585804-XReport Type:Expedited (15-DaCompany Report #2000026301-1 Age:59 YR Gender:Male I/FU:F Outcome Dose Disability PT Report Source Product Role Manufacturer Route Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Duration Corneal Disorder Keratoconjunctivitis 900 Sicca MILLIGRAMS Retinopathy ORAL Visual Acuity Reduced Jodthyrox (Levothyroxine) Vioxx (Rofecoxib) C C Date:09/29/00ISR Number: 3582977-XReport Type:Direct Age:63 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Company Report # Report Source Confusional State Dysphagia Dyspnoea Hyperhidrosis Mental Impairment Tremor Date:09/29/00ISR Number: 3583116-1Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose PT Lithium Tegretol Atenolol PS C C Report Source Product Role Lithium PS Route Manufacturer Route Company Report #8-99230-153A PT Report Source Product Role Manufacturer Route Drug Interaction Health Professional Premarin PS Wyeth Ayerst Laboratories Inc ORAL Duration 3 DAY Lithobid (Lithium) 22-Aug-2005 Page: 261 Manufacturer Duration Date:09/29/00ISR Number: 3584982-6Report Type:Periodic Age:45 YR Gender:Female I/FU:F ORAL Role Company Report # Blood Potassium Increased Renal Impairment Outcome Dose Other Product 10:48 AM SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/00ISR Number: 3585123-1Report Type:Expedited (15-DaCompany Report #WAES 00064287 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Disability PO 4 WK PT Report Source Product Role Manufacturer Route Drug Interaction Injury Pain Consumer Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL Manufacturer Route Tremor Lithiumco3 Date:10/02/00ISR Number: 3584575-0Report Type:Direct Age:83 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 225 AM + 450 Initial or Prolonged PM PO Company Report # PT Report Source Product Role Confusional State Health Lithium Cn750 PS Dehydration Professional Ec Asa Furosemide Lisinopril Malindone Salsalate Mvi Vit E C C C C C C C Date:10/02/00ISR Number: 3585280-7Report Type:Direct Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600 BID 1200 Initial or Prolonged MG PO QD SS PT Asthenia Company Report # Report Source Product Lithium Role Cn 750 PS Dysarthria Syncope ORAL Atenolol Diltiazem Diphenhydramine Haloperidol C C C C Manufacturer Route ORAL Date:10/02/00ISR Number: 3586254-2Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1 BID Initial or Prolonged Other 2 BID PT Report Source Product Role Drug Level Above Health Fosinopril 10mg PS Therapeutic Professional Lithium Carbonate 300 Mg SS Date:10/03/00ISR Number: 3585402-8Report Type:Direct Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report # PT Abnormal Behaviour Medication Error Sedation Speech Disorder 22-Aug-2005 Page: 262 10:48 AM Route Manufacturer Route Company Report # Report Source Product Role Lithium Cn750 PS Date:10/04/00ISR Number: 3587785-1Report Type:Expedited (15-DaCompany Report #9947674 Age: Gender:Female I/FU:F Outcome Required Intervention to Manufacturer FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage Dose PT Report Source Product Role Manufacturer Route Abdominal Pain Convulsion Study Consumer Zoloft PS Pfizer Pharmaceuticals Inc ORAL Duration 50.00 MG Dizziness TOTAL:DAILY:O Drug Ineffective RAL Liver Disorder Loss Of Consciousness Nervousness Nightmare Paraesthesia Syncope Vomiting Weight Decreased Lithium Prometazine Diazepam Thoridazine Maprotiline SS C C C C Date:10/05/00ISR Number: 3589152-3Report Type:Expedited (15-DaCompany Report #LBID00200005889 Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY PO PT Report Source Product Role Manufacturer Route Agitation Blood Creatinine Foreign Literature Lithobid PS Solvay Pharmaceuticals ORAL Increased Blood Ph Decreased Cerebellar Ataxia Dialysis Disorientation Drug Level Above Therapeutic Drug Toxicity Hyperkalaemia Hypothermia Intentional Misuse Nausea Other Date:10/06/00ISR Number: 3592056-3Report Type:Expedited (15-DaCompany Report #2000026969-1 Age: Gender:Unknown I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Overdose Literature Eskalith PS Smithkline Beecham Pharmaceuticals Alimemazine Benzodiazepines Venlafaxine C C C Route Duration Date:10/10/00ISR Number: 3592545-1Report Type:Expedited (15-DaCompany Report #JAOCAN2000000938 Age: Gender:Unknown I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Unevaluable Event Foreign Health Professional Risperdal PS Janssen Research Fdn Div Johnson And Johnson ORAL Duration ORAL Lithium (Lithium) ORAL 22-Aug-2005 Page: 263 10:48 AM SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/10/00ISR Number: 3592730-9Report Type:Expedited (15-DaCompany Report #LBID00200005900 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG BID PT Report Source Product Role Manufacturer Route Drug Interaction Drug Level Above Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Therapeutic Company Renal Disorder Representative PO, 300 MG QD PO Vioxx SS ORAL DAILY PO Date:10/11/00ISR Number: 3592893-5Report Type:Direct Age:61 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL MG QID PT Company Report # Report Source Product Role Manufacturer Route Asthenia Balance Disorder Lithium Carbonate (300mg Qid)(Roxane) PS Roxane ORAL Decreased Activity Dizziness Sinemet Olanzapine Fluoxetine Insulin Regular Hctz Albuterol Metformin Lisinopril C C C C C C C C Date:10/13/00ISR Number: 3595482-1Report Type:Expedited (15-DaCompany Report #PHFR2000GB01523 Age:60 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 400MG/DAY, ORAL PT Report Source Product Role Manufacturer Route Atrioventricular Block Complete Foreign Health Tegretol PS Novartis Pharmaceuticals Corp ORAL Coordination Abnormal Professional Drug Interaction Other Lithium(Lithium) SS ORAL Anafranil(Clomiprami ne Hydrochloride) Tablet SS ORAL Bendrofluazide(Bendr ofluazide) SS ORAL 800MG/DAY, Nodal Arrhythmia ORAL 300MG/DAY, ORAL 2.5MG/DAY, ORAL Thyroxine Fluoxetine (Fluoxetine) C C Date:10/16/00ISR Number: 3595805-3Report Type:Expedited (15-DaCompany Report #2000027172-1 Age:60 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1125 Other MILLIGRAMS 22-Aug-2005 Page: 264 10:48 AM PT Report Source Product Role Manufacturer Route Leukocytosis Lymphocytic Leukaemia Foreign Health Quilonum (Lithium) PS Smithkline Beecham Pharmaceuticals ORAL Thrombocythaemia Professional FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/17/00ISR Number: 3596701-8Report Type:Expedited (15-DaCompany Report #LBID00200006014 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PO, 1400 MG DAILYPO 9 PT Report Source Product Role Manufacturer Route Hyperparathyroidism Hypocalcaemia Foreign Literature Lithobid PS Solvay Pharmaceuticals ORAL Mania Health Post Procedural Complication Professional Other YR Date:10/17/00ISR Number: 3596713-4Report Type:Expedited (15-DaCompany Report #LBID00200006026 Age:57 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1000 MG DAILY PT Report Source Product Role Manufacturer Route Agitation Blood Creatinine Foreign Literature Lithobid PS Solvay Pharmaceuticals ORAL Increased Other PO Blood Urea Increased Clonic Convulsion Captopril (Captopril) Confusional State Coordination Abnormal Drug Toxicity Encephalopathy Hypertension Sedation Nifedipine (Nifedipine) Haloperidol (Haloperidol) SS ORAL 50 MG TID PO C C Date:10/17/00ISR Number: 3596731-6Report Type:Expedited (15-DaCompany Report #LBID00200006021 Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 750 MG DAILY PO, 600 MG PT Report Source Product Role Manufacturer Route Blood Urea Increased Confusional State Foreign Literature Lithobid PS Solvay Pharmaceuticals ORAL Coordination Abnormal Health Delirium Professional DAILY PO, 750 Drug Interaction MG DAILY PO 5 YR Drug Level Below Diovan (Valsartan) SS 80 MG DAILY Therapeutic PO, 80 MG Grandiosity DAILY PO 2 WK Medication Error 22-Aug-2005 Page: 265 10:48 AM Quetiapine (Quetiapine) Zopiclone (Zopiclone) L-Tryptophan (L-Tryptophan) Lorazepam (Lorazepam) Glyburide (Glyburide) Conjugated Estrogen (Estrogens Conjugated) Ciprofloxacin (Ciprofloxacin) C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/00ISR Number: 3597622-7Report Type:Expedited (15-DaCompany Report #A033638 Age:63 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 900.00 MG Initial or Prolonged TOTAL:TID:ORA PT Report Source Product Role Manufacturer Route Autonomic Nervous System Literature Lithium Carbonate PS Pfizer Inc ORAL Imbalance Health Blood Creatine Professional Amoxapine SS ORAL Benztropine SS ORAL Lorazepam Atenolol Verapamil C C C L Phosphokinase Increased 300.00 MG Blunted Affect TOTAL:TID:ORA Decreased Activity L Disturbance In Attention 3.00 MG Extrapyramidal Disorder TOTAL:TID:ORA Hyperhidrosis L Hypertension Judgement Impaired Leukocytosis Major Depression Muscle Rigidity Myoglobinuria Neuroleptic Malignant Syndrome Pyrexia Renal Impairment Tachycardia Date:10/23/00ISR Number: 3599834-5Report Type:Direct Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Other 150MG PO TID PT Diabetes Insipidus Company Report # Report Source Product Role Lithium PS Manufacturer Route ORAL Date:10/23/00ISR Number: 3599848-5Report Type:Direct Age:61 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Lithium PS Manufacturer Route Route Duration Confusional State Feeling Jittery Lethargy Leukocytosis Tachycardia Date:10/24/00ISR Number: 3600441-6Report Type:Direct Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Death Life-Threatening 250MG 2 WK Hospitalization Initial or Prolonged 1200 MG 10 MON Other 22-Aug-2005 Page: 266 Company Report # 10:48 AM Company Report # PT Report Source Product Role Manufacturer Hepatic Cirrhosis Hepatic Steatosis Health Professional Depakote 250mg Abbott PS Abbott Lithium 1200mg Ciba-Geigy Co SS Ciba-Geigy Co Liver Disorder Nephrolithiasis Renal Cyst Renal Neoplasm Urinary Incontinence FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/00ISR Number: 3600790-1Report Type:Periodic Age:58 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1 TABLET 2.0 DAILY ORAL 20 Company Report #2000022074-1 PT Report Source Product Role Manufacturer Route Therapeutic Agent Toxicity Health Professional Eskalith Cr PS Smithkline Beecham Pharmaceuticals ORAL YR Marplan (Isocarboxid) Tegretol (Carbamazepine) Cozaar (Losartain Potassium) Seroquel (Quetiapine Fumurate) Date:10/24/00ISR Number: 3600791-3Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL MILLIGRAMS 3.0 DAILY ORAL C C C Company Report #2000024320-1 PT Report Source Product Role Manufacturer Route Hypercalcaemia Hyperparathyroidism Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Date:10/24/00ISR Number: 3600792-5Report Type:Periodic Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 C Company Report #2000003113-1 PT Report Source Product Role Manufacturer Route Dermatitis Pruritus Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Date:10/24/00ISR Number: 3601132-8Report Type:Expedited (15-DaCompany Report #EWC000807564 Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 20 MG/DAY Initial or Prolonged 900 MG/DAY Other 22-Aug-2005 Page: 267 10:48 AM PT Report Source Product Role Manufacturer Breast Pain Foreign Zyprexa PS Eli Lilly And Co Bundle Branch Block Right Study Lithium SS Deep Vein Thrombosis Delusion Of Reference Dyspnoea Electrocardiogram Abnormal Erotomanic Delusion Escherichia Sepsis Haematocrit Decreased Haemoglobin Decreased Iron Deficiency Anaemia Lung Disorder Mean Cell Volume Decreased Pulmonary Embolism Streptococcal Sepsis Therapeutic Agent Toxicity Health Professional Other Lorazepam C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/00ISR Number: 3601251-6Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300MG PO BID Initial or Prolonged PRIOR TO PT Company Report # Report Source Asthenia Product Role Lithium PS Zoloft Phenobarbital Claritin Aspirin Prilosec Kcl Lasix Synthroid Miacalcin Detrol Atacand C C C C C C C C C C C Manufacturer Route ORAL Drug Toxicity ADMISSION Date:10/26/00ISR Number: 3602189-0Report Type:Expedited (15-DaCompany Report #WAES 00064287 Age:73 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Condition Aggravated Drug Interaction Tremor Consumer Other Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL 25MG/DAILY/PO Lithiniumco3 450 Mg SS Avapro Deseril Fosamax Lipitor Premarin Aspirin C C C C C C 450 MG/DAILY Date:10/26/00ISR Number: 3602202-0Report Type:Expedited (15-DaCompany Report #LITH00200006065 Age: Gender:Female I/FU:I Outcome Dose Duration Death Life-Threatening UNK DAILY PO Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Overdose Renal Failure Health Professional Lithonate PS Solvay Pharmaceuticals ORAL Manufacturer Route Company Representative Date:10/26/00ISR Number: 3605756-3Report Type:Expedited (15-DaCompany Report #SP-200001922 Age:52 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Drug Interaction INTRAVENOUS INTRAVENOUS Initial or Prolonged Hypercalcaemia INFUSION Required INTRAVENOUS INTRAVENOUS Intervention to INFUSION Prevent Permanent INTRAVENOUS INTRAVENOUS Impairment/Damage INFUSION Report Source Product Role Foreign Remicade PS Remicade SS Remicade SS Lithium SS Acetaminophen With Codeine Eltroxin Losec C C C Study Health Professional ORAL 600MG AT BEDTIME 22-Aug-2005 Page: 268 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Medroxyprogesterone Timolol Motilium Vita-Vim Vitamin E Zyprexa Clonazepam Oxazepam Pantoloc Prednisone Premarin Fluconazole Insulin Humulin Ultralente Vasotec Mobiflex Humalog Amoxicillin Clonazepam Cytotec Biaxin C C C C C C C C C C C C C C C C C C C C Date:10/30/00ISR Number: 3604211-4Report Type:Expedited (15-DaCompany Report #WAES 00101917 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Drug Interaction Drug Level Above Therapeutic Health Professional Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL DAILY/PO Drug Toxicity Lithobid 300 Mg SS ORAL 300 MG/BID/PO Renal Disorder Date:10/31/00ISR Number: 3604996-7Report Type:Expedited (15-DaCompany Report #LBID00200005900 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG BID PO 10 YR PT Report Source Product Role Manufacturer Route Drug Interaction Drug Level Above Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Therapeutic Company Vioxx (Rofecoxib) Dysarthria Representative SS ORAL UNKNOWN DAILY PO Hemiparesis Renal Disorder Date:11/02/00ISR Number: 3605796-4Report Type:Direct Age:45 YR Gender:Female I/FU:I Outcome Dose Disability PT Company Report # Report Source Product Role Aspartame In Diet Coke PS Klonipin Lithium SS SS Amnesia Feeling Abnormal 5 DIET COKES Feeling Drunk / DAY Headache Vision Blurred 22-Aug-2005 Page: 269 Manufacturer Route Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/00ISR Number: 3606454-2Report Type:Expedited (15-DaCompany Report #2000030745-1 Age:56 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1350 PT Report Source Product Role Manufacturer Route Electrocardiogram Abnormal Foreign Health Eskalith Cr PS Smithkline Beecham Pharmaceuticals ORAL Professional MILLIGRAMS Carbamazepine (Tegretal) Zotepin (Nipolept) C C Date:11/06/00ISR Number: 3607731-1Report Type:Expedited (15-DaCompany Report #2000031294-1 Age:73 YR Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Manufacturer Route Duration Drug Interaction Drug Level Above 450 Therapeutic MILLIGRAMS Celecoxib Venlafaxine Date:11/07/00ISR Number: 3607759-1Report Type:Direct Age:50 YR Gender: I/FU:I Outcome Dose Duration Hospitalization 450 MG AM Initial or Prolonged 900MG Q PM PT Confusional State Company Report # Report Source Product Role Lithium PS Diarrhoea Mental Impairment Date:11/07/00ISR Number: 3607777-3Report Type:Direct Age:47 YR Gender:Female I/FU:I C C Company Report # Outcome Dose PT Report Source Product Role Blood Creatinine Lico3 PS Increased Lisinopril SS Manufacturer Route Duration 600MG BID 10MG QAM Blood Urea Increased Diarrhoea Dizziness Drug Toxicity Hypotension Nausea Vomiting Date:11/07/00ISR Number: 3608645-3Report Type:Expedited (15-DaCompany Report #FLUV00300006081 Age:44 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Difficulty In Walking Dizziness Foreign Health Luvox PS Solvay Pharmaceuticals ORAL Drug Level Below Professional Therapeutic Other Duration 75 MG DAILY PO, 100 MG DAILY PO, Medication Error DAILY PO Nausea Oral Intake Reduced 200 MG TID PO 22-Aug-2005 Page: 270 10:48 AM Limas (Lithium Carbonate) SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/00ISR Number: 3608744-6Report Type:Direct Age:43 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 300MG PO BID Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Blood Creatinine Product Role Lithium PS Manufacturer Route ORAL Increased Convulsion Hyperglycaemia Hypernatraemia Hypochloraemia Pneumonia Aspiration Date:11/09/00ISR Number: 3610283-3Report Type:Expedited (15-DaCompany Report #2000031588JP Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Convulsion Depressed Level Of Foreign Health Xanax PS Pharmacia And Upjohn Co ORAL Consciousness Excitability Professional Other Prothiaden(Dosulepin )Tablet SS ORAL Haemodialysis Hyperhidrosis Limas(Lithium Carbonate) Tablet SS ORAL Pyrexia Restlessness Therapeutic Agent Toxicity Tremor Propranolol Hydrochloride(Propra nolol Hydrochloride) C BID, ORAL TID, ORAL BID, ORAL Date:11/13/00ISR Number: 3611163-XReport Type:Periodic Age:23 YR Gender:Male I/FU:I Outcome Dose Other Company Report #FLUV00299000297 PT Report Source Product Role Manufacturer Route Psychotic Disorder Consumer Luvox PS Solvay Pharmaceuticals ORAL Duration 100 MG QD PO Lithonate (Lithium Carbonate) SS ORAL DAILY PO, 1500 MG DAILY PO Sinequan (Doxepin Hydrochloride) Thyroid Hormones (Thyroid Hormones) Date:11/13/00ISR Number: 3611270-1Report Type:Periodic Age:37 YR Gender:Female I/FU:I Outcome Dose Other C C Company Report #FLUV00299001176 PT Report Source Product Role Manufacturer Route Vomiting Health Professional Luvox PS Solvay Pharmaceuticals ORAL Duration PO Lithobid (Lithum Carbonate) SS DAILY PO Ativan (Lorazepam) Ambein (Zolpidem Tartrate) Navane (Tiotixene) Cogentin (Benzatropine Mesilate) 22-Aug-2005 Page: 271 10:48 AM C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/00ISR Number: 3611336-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #FLUV00299000236 PT Report Source Product Role Manufacturer Route Amblyopia Drug Level Above Health Professional Luvox PS Solvay Pharmaceuticals ORAL Therapeutic Speech Disorder Company Representative Lithium Carbonate (Lithium Carbonate) Duration 100 MG TID PO SS ORAL 600 MG BID PO, 300 MG QD PO Mellaril (Thioridazine Hydrochloride) Buspar (Buspirone Hydrochloride) Zyprexa (Olanzapine) C C C Date:11/13/00ISR Number: 3612451-3Report Type:Expedited (15-DaCompany Report #SP-200001922 Age:52 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Drug Interaction INTRAVENOUS INTRAVENOUS Initial or Prolonged Hypercalcaemia INFUSION Required Nausea INTRAVENOUS INTRAVENOUS Intervention to Polyuria INFUSION Prevent Permanent Vomiting INTRAVENOUS INTRAVENOUS Impairment/Damage INFUSION ORAL Report Source Product Role Foreign Remicade PS Remicade SS Remicade SS Lithium SS Acetaminophen With Codeine C Manufacturer Route Study Health Professional 600MG AT BEDTIME ORAL Amoxicillin Clonazepam Cytotec Biaxin Eltroxin Humalog (Insulin Analog) Losec Mobiflex Medroxyprogesterone Vasotec Timolol Premarin Prednisone Pantoloc Oxazepam Zyprexa Vitamin E Vita-Vim Motilium Insulin Humulin Ultralente Fluconazole 22-Aug-2005 Page: 272 10:48 AM C C C C C C C C C C C C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/00ISR Number: 3614248-7Report Type:Periodic Age:25 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 50 MG QD PO Company Report #FLUV00299001066 PT Report Source Product Role Manufacturer Route Hyperglycaemia Leukocytosis Health Professional Luvox PS Solvay Pharmaceuticals ORAL Myasthenic Syndrome Lithium SS Ativan Zyprexa C C ORAL DAILY PO Date:11/14/00ISR Number: 3611476-1Report Type:Expedited (15-DaCompany Report #WAES 00110445 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Drug Level Above Therapeutic Health Professional Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL 25 MG/DAILY/PO 5 DAY Lithium Carbonate (Roxane) SS 900 MG/DAILY/UNK Date:11/14/00ISR Number: 3613302-3Report Type:Periodic Age:26 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Hypertonia Health Professional Sinequan PS Pfizer Laboratories Div Pfizer Inc ORAL Duration 75.00 MG TOTAL:DAILY:O RAL Company Report #A027306 Depakote SS Lithobid SS Seroquel SS 1500.00 MG TOTAL:BID 600 MG TOTAL BID 25MG TOTAL DAILY Date:11/14/00ISR Number: 3613322-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #A020603 PT Report Source Product Role Manufacturer Route Drug Ineffective Gastrointestinal Consumer Health Sinequan PS Pfizer Laboratories Div Pfizer Inc ORAL Candidiasis Professional Duration 125.00 MG TOTAL:DAILY:O Personality Disorder RAL Thinking Abnormal Eskalith Cr 675.00 MG TOTAL:DAILY:O RAL Date:11/15/00ISR Number: 3611776-5Report Type:Direct Age:40 YR Gender:Male I/FU:I Outcome Death 22-Aug-2005 Page: 273 PT Circulatory Collapse Dermatitis Drug Toxicity Fatigue Fear 10:48 AM Company Report # SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nervousness Panic Disorder Renal Failure Dose Report Source Product Role Lithium - Pills PS Manufacturer Route Duration Swelling 3X PER DAY Date:11/16/00ISR Number: 3612801-8Report Type:Expedited (15-DaCompany Report #2000032410-1 Age: Gender:Male I/FU:I Outcome Dose Disability Other ORAL PT Report Source Product Role Manufacturer Route Amyotrophic Lateral Sclerosis Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Duration Bulbar Palsy Extrapyramidal Disorder Flupentixol C Date:11/16/00ISR Number: 3612895-XReport Type:Expedited (15-DaCompany Report #2000032527-1 Age:45 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Confusional State Delirium Foreign Health Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Dysarthria Professional Judgement Impaired Restlessness Other Duration 2144 MILLIGRAMS Biperiden (Akineton) Chloral (Chloradurat) Clomipramine (Anafranil) Diazepam Risperidone (Risperdal) Date:11/16/00ISR Number: 3613082-1Report Type:Expedited (15-DaCompany Report #PHNU2000DE02101 Age:54 YR Gender:Female I/FU:I C C C C C Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Drug Level Above Therapeutic Foreign Study Clozaril PS Novartis Pharmaceuticals Corp ORAL Fall Hypotonia Health Professional Other Hypnorex - Slow Release (Lithium Carbonate) SS ORAL Saroten SS ORAL Torem (Torasemide) SS ORAL Allopurinol C ORAL ORAL ORAL Date:11/16/00ISR Number: 3613084-5Report Type:Expedited (15-DaCompany Report #PHNU2000DE02098 Age:69 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Atrioventricular Block First Degree Foreign Study Clozaril PS Novartis Pharmaceuticals Corp ORAL Cold Sweat Electrocardiogram Qt Health Professional Hypnorex (Lithium Carbonate) SS ORAL Prolonged Heart Rate Decreased Other Akineton(Biperiden Hydrochloride) SS ORAL Sick Sinus Syndrome Haldol (Haloperidol) SS ORAL Sinoatrial Block Saroten SS ORAL ORAL ORAL ORAL ORAL Sinus Bradycardia 22-Aug-2005 Page: 274 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/00ISR Number: 3613086-9Report Type:Expedited (15-DaCompany Report #2000033402FR Age: Gender:Female I/FU:F Outcome Dose Duration Disability Congenital Anomaly PT Report Source Product Role Manufacturer Anal Atresia Apgar Score Low Caesarean Section Complications Of Maternal Exposure To Therapeutic Foreign Health Professional Other Xanax PS Pharmacia And Upjohn Co Tercian(Cyamemazine) Teralithe(Lithium Carbonate) SS SS Route ORAL ORAL Drugs Congenital Genitourinary Abnormality Congenital Renal Cyst Diabetes Insipidus Heart Disease Congenital Hypercalcaemia Hyponatraemia Kidney Small Multiple Congenital Abnormalities Neonatal Disorder Pregnancy Date:11/17/00ISR Number: 3613556-3Report Type:Expedited (15-DaCompany Report #JACGER2000001716 Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Arrhythmia Atrioventricular Block Bradycardia Bundle Branch Block Right Foreign Health Professional Haldol PS Rw Johnson Pharmaceutical Research Institute Div Ortho Pharm ORAL MG, DAILY, Cold Sweat ORAL Electrocardiogram Qt Prolonged Hypnorex (Lithium Carbonate) SS ORAL Akineton (Biperiden Hydrochloride) SS ORAL MG, DAILY, Sick Sinus Syndrome ORAL Sinus Bradycardia MG, DAILY, ORAL Leponex (Clozapine) SS ORAL Saroten (Amitriptyline Hydrochloride) SS ORAL Fluanxol (Flupentixol) C MG, DAILY, ORAL MG, DAILY, ORAL Date:11/20/00ISR Number: 3615374-9Report Type:Expedited (15-DaCompany Report #2000027172-1 Age:60 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1125 Other MILLIGRAMS ORAL 22-Aug-2005 Page: 275 10:48 AM PT Report Source Product Role Manufacturer Route Chronic Lymphocytic Leukaemia Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Thrombocythaemia FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/00ISR Number: 3615628-6Report Type:Expedited (15-DaCompany Report #PRIUSA2000012580 Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Blood Creatinine Increased Coordination Abnormal Creatinine Renal Foreign Literature Health Professional Levaquin PS Rw Johnson Pharmaceutical Research Institute Div Ortho Pharm ORAL 300 MG, Clearance Decreased DAILY, ORAL Drug Interaction Drug Level Above Lithium Carbonate (Lithium Carbonate) SS ORAL 1200 MG, Therapeutic DAILY, ORAL Dysarthria Mania Medication Error Tremor Upper Respiratory Tract Infection Vomiting Date:11/21/00ISR Number: 3615802-9Report Type:Expedited (15-DaCompany Report #2000032060-1 Age:61 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Drug Interaction Drug Level Above Therapeutic Drug Toxicity Report Source Product Role Manufacturer Eskalith PS Smithkline Beecham Pharmaceuticals Bisoprolol Carbamazepine (Tegretol) Lithium (Priadel) Ramipril Risperidone Thyroxine C Date:11/22/00ISR Number: 3616651-8Report Type:Expedited (15-DaCompany Report #2000032060-1 Age:61 YR Gender:Female I/FU:I C C C C C Route Outcome Dose Duration Hospitalization Initial or Prolonged PT Drug Interaction Drug Level Above Therapeutic Drug Toxicity Report Source Product Role Manufacturer Eskalith PS Smithkline Beecham Pharmaceuticals Bisoprolol Carbamazepine Lithium Ramipril Risperidone Thyroxine C C C C C C Date:11/24/00ISR Number: 3616392-7Report Type:Expedited (15-DaCompany Report #LITH00200006356 Age: Gender:Female I/FU:I Outcome Death Hospitalization Initial or Prolonged 22-Aug-2005 Page: 276 10:48 AM PT Abnormal Behaviour Agitation Diarrhoea Drug Level Above Therapeutic Drug Toxicity Lethargy Psychotic Disorder Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Dose Report Source Product Role Manufacturer Route Health Professional Lithonate PS Solvay Pharmaceuticals ORAL Duration DAILY PO Date:11/27/00ISR Number: 3617526-0Report Type:Expedited (15-DaCompany Report #A035977 Age:47 YR Gender:Male I/FU:F Outcome Dose Duration Required Intervention to ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Abdominal Pain Diarrhoea Consumer Health Zithromax PS Pfizer Chemicals Div Pfizer Inc ORAL Drug Interaction Drug Toxicity Flatulence Intervertebral Disc Degeneration Pain Polyp Proctalgia Professional Metronidazole Lithium Klonopin Artane Ultram Moban Date:11/27/00ISR Number: 3622964-6Report Type:Periodic Age:26 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 450 MG ORAL Initial or Prolonged 900 MG 3 MON PT SS SS C C C C Company Report #PHEH1999US03798 Report Source Product Role Manufacturer Route Convulsion Coordination Abnormal Clozaril PS Novartis Pharmaceuticals Corp ORAL Disorientation Lithium SS Fall Leukocytosis Sedation Stupor Tachycardia Tremor Risperdal Effexor (Venlafaxine Hydrochloride) Lithobid (Lithium Carbonate) Depakene (Valproate Sodium) Tavist (Clemastine C C C C Fumarate) Ddavap (Desmopressin) Prednisone Date:11/27/00ISR Number: 3631312-7Report Type:Periodic Age:46 YR Gender:Female I/FU:I Outcome Dose C C C Company Report #PHEH2000US08188 PT Report Source Product Role Manufacturer Route Drug Interaction Parotid Gland Enlargement Health Professional Clozaril PS Novartis Pharmaceuticals Corp ORAL Duration 100 MG AM+300 MG HS, ORAL 751 DAY 751 DAY 730 DAY Lithium(Lithium) SS Zoloft SS Date:11/30/00ISR Number: 3620070-8Report Type:Expedited (15-DaCompany Report #17812-117 Age: Gender:Male I/FU:I Outcome Death 22-Aug-2005 Page: 277 PT Circulatory Collapse Completed Suicide 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Dermatitis Drowning Drug Toxicity Report Source Product Role Manufacturer Fatigue Hallucination Consumer Other Lithium Carbonate PS Roxane Laboratories Inc Route Duration TID Nervousness Renal Failure Swelling Date:11/30/00ISR Number: 3627155-0Report Type:Periodic Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Disability 400 MG / PER DAY / ORAL 6 Company Report #A0116644A PT Report Source Product Role Manufacturer Route Tic Health Wellbutrin Sr PS Glaxo Wellcome Inc ORAL Tremor Professional Lithium Salt Methadone Hydrochloride SS Tamsulosin Hcl Psychiatric Consultation C WK SS ORAL 250 MG / FOUR TIMES PER DAY ORAL C Date:12/07/00ISR Number: 3624704-3Report Type:Expedited (15-DaCompany Report #LBID00200006463 Age:37 YR Gender:Male I/FU:I Outcome Dose Duration Death Life-Threatening PT Report Source Product Role Manufacturer Route Dermatitis Drug Toxicity Fatigue Consumer Lithobid PS Solvay Pharmaceuticals, Inc. ORAL DAILY PO Nervousness Panic Reaction Renal Failure Swelling Date:12/08/00ISR Number: 3625507-6Report Type:Expedited (15-DaCompany Report #LBID00200006500 Age:37 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 450 MG BID PO PT Report Source Product Role Manufacturer Route Mania Foreign Literature Lithobid PS Solvay Pharmaceuticals ORAL Route Health Professional Date:12/08/00ISR Number: 3625593-3Report Type:Expedited (15-DaCompany Report #A032735 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 278 10:48 AM PT Report Source Product Role Manufacturer Arthritis Bipolar I Disorder Blood Cholesterol Increased Cystitis Erectile Dysfunction Middle Insomnia Overdose Consumer Health Professional Cardura PS Pfizer Laboratories Div Pfizer Inc Lithium Depakote SS C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/00ISR Number: 3626495-9Report Type:Expedited (15-DaCompany Report #A035977 Age:47 YR Gender:Male I/FU:F Outcome Dose Duration Required Intervention to ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Colitis Colonic Polyp Consumer Health Zithromax PS Pfizer Chemicals Div Pfizer Inc ORAL Drug Interaction Drug Toxicity Professional Metronidazole Lithium Klonopin Artane Ultram Moban Manufacturer Route SS SS C C C C Date:12/11/00ISR Number: 3626949-5Report Type:Expedited (15-DaCompany Report #AU_000501403 Age:23 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Affective Disorder 6 DSG Initial or Prolonged Aggression FORM/DAY 33 DAY Agitation 4 DSG Alanine Aminotransferase FORM/DAY Increased 20 MG/DAY Anxiety Depression Irritability Mania Report Source Product Role Foreign Lithium PS Placebo SS Olazapine SS Study Health Professional Other Date:12/11/00ISR Number: 3627141-0Report Type:Expedited (15-DaCompany Report #2000033870-1 Age:63 YR Gender:Female I/FU:I Outcome Dose Disability PT Report Source Product Role Manufacturer Route Arthralgia Arthropathy Blood Disorder Foreign Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Tibolone (Liviella) C Duration Blood Uric Acid Increased Diarrhoea Hypoaesthesia Joint Swelling Peripheral Vascular Disorder Weight Increased Other Date:12/12/00ISR Number: 3628775-XReport Type:Expedited (15-DaCompany Report #WAES 00101917 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Drug Interaction Drug Level Above Therapeutic Health Professional Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL DAILY/PO Renal Disorder Lithobid 300 Mg SS ORAL Lithobid 300 Mg SS ORAL 300 MG/BID/PO 300 MG/DAILY/PO 22-Aug-2005 Page: 279 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/00ISR Number: 3630247-3Report Type:Expedited (15-DaCompany Report #2000022195-1 Age:30 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Abortion Induced Pregnancy Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Duration ORAL Date:12/18/00ISR Number: 3633315-5Report Type:Expedited (15-DaCompany Report #JACFRA2000000803 Age:69 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Coma Hypercalcaemia Hypernatraemia Foreign Health Professional Risperdal 7-Day Starter Pack PS Janssen Research Fdn Div Johnson And Johnson ORAL ORAL Lithium Microsol SS ORAL ORAL Date:12/19/00ISR Number: 3632893-XReport Type:Expedited (15-DaCompany Report #A0134381A Age:33 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 200MG Twice Initial or Prolonged per day 2 YR PT Report Source Alcoholism Product Role Manufacturer Route Lamictal PS Glaxo Wellcome ORAL Zyprexa Lithium Norvasc SS SS C Manufacturer Route Anxiety Bipolar Disorder Condition Aggravated Drug Effect Decreased Mood Altered Date:12/20/00ISR Number: 3635106-8Report Type:Expedited (15-DaCompany Report #A038831 Age: Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Hospitalization Initial or Prolonged Required 500.00 Intervention to TOTAL:BID Prevent Permanent 600.00 MG Impairment/Damage TOTAL:BID:ORA Depressed Level Of Consciousness Drug Interaction Health Professional Zoloft PS Tikosyn SS Lithium SS Pepcid Atrovent Lasix Digoxin Ventolin Plavix Aspirin C C C C C C C Pfizer Pharmaceuticals Inc Dysphagia Hepatitis ORAL Lethargy L Date:12/20/00ISR Number: 3635124-XReport Type:Expedited (15-DaCompany Report #A0134381A Age:33 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 200 MG/ TWICE Initial or Prolonged PER DAY/ ORAL 2 YR PT Report Source Product Role Manufacturer Route Bipolar Disorder Health Lamictal PS Glaxo Wellcome Inc ORAL Drug Ineffective Professional Olanzapine (Formulation Unknown) (Olanzapine) Lithium Salt 22-Aug-2005 Page: 280 10:48 AM SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Formulation Unknown) (Lithium Salt) Amlodipine SS C Date:12/20/00ISR Number: 3635728-4Report Type:Expedited (15-DaCompany Report #2000035222-1 Age:64 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Anxiety Asthenia Depression Diarrhoea Fatigue Headache Hypersomnia Insomnia Restlessness Literature Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals Fluoxetine Sertraline C C Route Date:12/26/00ISR Number: 3638132-8Report Type:Expedited (15-DaCompany Report #PHEH2000US10807 Age:80 YR Gender:Male I/FU:F Outcome Dose Duration Death Life-Threatening 3 MG, BID, Hospitalization ORAL Initial or Prolonged 500 MG, QD 110 DAY PT Report Source Product Role Manufacturer Route Cardiac Arrest Cerebrovascular Accident Study Health Exelon PS Novartis Pharmaceuticals Corp ORAL Myocardial Infarction Professional Route Lithium (Lithium) SS Cardura (Doxazosin Mesilate) C Date:12/28/00ISR Number: 3639207-XReport Type:Expedited (15-DaCompany Report #HQ5230622DEC2000 Age:52 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization - PT Report Source Product Role Manufacturer Drug Interaction Foreign Effexor PS Wyeth Ayerst Initial or Prolonged 150 MG DAILY ORAL 4 Pulmonary Embolism Health Pyrexia Professional 2 Teralithe (Lithium Carbonate) PT Route Company Report # Report Source Product Role Dehydration Lithium (300mg) PS Depressed Level Of Consciousness Nephrogenic Diabetes Insipidus Pneumonia Aspiration Tegretol C Duration TID Date:12/29/00ISR Number: 3640251-7Report Type:Expedited (15-DaCompany Report #HQ5204122DEC2000 Age:70 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 281 Manufacturer SS DAY Date:12/29/00ISR Number: 3638664-2Report Type:Direct Age:62 YR Gender:Male I/FU:I Outcome Dose ORAL DAY Other 400 MG DAILY Laboratories 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Dose PT Report Source Product Role Manufacturer Route Drug Level Above Therapeutic Health Professional Effexor PS Wyeth Ayerst Laboratories ORAL Fall Other Duration 200 MG 1 X PER 1 DAY, Serotonin Syndrome ORAL Teralithe (Lithium Carbonate) 1000 MG SS ORAL 1X PER 1 DAY, ORAL Date:01/02/01ISR Number: 3640473-5Report Type:Expedited (15-DaCompany Report #2000AU03968 Age:51 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 20 MG QD PO Initial or Prolonged PT Report Source Product Role Manufacturer Route Blood Potassium Decreased Health Prilosec PS Astrazeneca Lp ORAL Drug Interaction Drug Toxicity Heart Rate Increased Professional Lithium Trazodone Wellbutrin SS SS SS Manufacturer Route Date:01/10/01ISR Number: 3645451-8Report Type:Direct Age:58 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Neurotoxicity Company Report # Report Source Product Role Lithium Carbonate 300 Mg Bid Vioxx Ultram PS C C Date:01/11/01ISR Number: 3646483-6Report Type:Expedited (15-DaCompany Report #2000037052-1 Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Psychotic Disorder Thrombocythaemia White Blood Cell Count Increased Health Professional Lithium PS Smithkline Beecham Pharmaceuticals Granulocyte Colony-Stimulating Factor C Date:01/11/01ISR Number: 3647836-2Report Type:Periodic Age:34 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG QAM & Company Report #17812-114 PT Report Source Product Role Manufacturer Route Convulsion Health Professional Lithium Carbonate PS Roxane Laboratories Inc ORAL 600 MG QPM, PO Klonopin Vistaril Chlorpromazine 22-Aug-2005 Page: 282 10:48 AM Route C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/01ISR Number: 3647837-4Report Type:Periodic Age:61 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG. QID, Company Report #17812-109 PT Report Source Product Role Manufacturer Route Asthenia Coordination Abnormal Health Professional Lithium Carbonate PS Roxane Laboratories Inc ORAL Dizziness PO Overdose Sinemet Olanzapine Fluoxetine Metformin Insulin Albuterol/Beclometha sone Mdi Lisinopril Date:01/11/01ISR Number: 3647838-6Report Type:Periodic Age:41 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG, BID, Other PO 10 YR PT Report Source Product Role Manufacturer Route Arrhythmia Dizziness Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Date:01/11/01ISR Number: 3647839-8Report Type:Periodic Age:53 YR Gender:Male I/FU:I C C C Company Report #17812-098 PT Report Source Product Role Manufacturer Route Asthenia Overdose Health Professional Lithium Carbonate PS Roxane Laboratories Inc ORAL Vision Blurred TID C C Company Report #17812-107 Trazadone Klonopin Motrin Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG, PO, C C C C C Haloperidol Aspirin Ec Phenytoin Fluconazole Bactrin Ds Clotrimazole Lotion Betamethasone Oint Theravite Date:01/11/01ISR Number: 3647840-4Report Type:Periodic Age:46 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG/QD/PO Company Report #17812-094 PT Report Source Product Role Manufacturer Route Coordination Abnormal Speech Disorder Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Prozac Depakote Xanax Neurontin 22-Aug-2005 Page: 283 10:48 AM C C C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/11/01ISR Number: 3647841-6Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Overdose Other Lithium Carbonate PS Roxane Laboratories Inc Nsaids C Route Duration Date:01/11/01ISR Number: 3647842-8Report Type:Periodic Age:44 YR Gender:Male I/FU:I Outcome Dose Other Company Report #17812-095 Company Report #17812-096 PT Report Source Product Role Manufacturer Route Vomiting Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 1200 MG, QHS, PO 11 YR Date:01/11/01ISR Number: 3647843-XReport Type:Periodic Age:46 YR Gender:Female I/FU:I Outcome Dose Other Company Report #17812-092 PT Report Source Product Role Manufacturer Route Dermatitis Consumer Lithium Carbonate PS Roxane Laboratories Inc ORAL Duration 300 MG, TID, PO Prozac Date:01/11/01ISR Number: 3647844-1Report Type:Periodic Age:48 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG, TID, C Company Report #17812-088 PT Report Source Product Role Manufacturer Route Confusional State Overdose Health Professional Lithium Carbonate PS Roxane Laboratories Inc ORAL Sedation PO Speech Disorder Chlorpromazine Valproate Sodium Olanzapine Furosemide Oxybutin Ipratropium Albuterol Theophylline Lansoprazole Digoxin Kcl Triamcinolone Aerosol Date:01/11/01ISR Number: 3647845-3Report Type:Periodic Age:71 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1500 MG QD, C C C C C C C C C C C C Company Report #17812-085 PT Report Source Product Role Manufacturer Dehydration Drug Toxicity Health Professional Lithium Carbonate PS Roxane Laboratories Inc Captopril Asa C C Overdose PO; >600 MG, Stupor QD PO 22-Aug-2005 Page: 284 10:48 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/15/01ISR Number: 3650370-7Report Type:Expedited (15-DaCompany Report #2001000474-1 Age:10 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Dermatitis Initial or Prolonged Hepatic Failure SEE IMAGE 38 DAY Pyrexia Renal Failure Report Source Product Role Manufacturer Route Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Zyprexa Klonopin Adderall C C C Date:01/16/01ISR Number: 3648374-3Report Type:Expedited (15-DaCompany Report #2001000229-1 Age:21 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 675 Required MILLIGRAMS Intervention to 2.0 DAILY Prevent Permanent ORAL Impairment/Damage PT Report Source Product Role Manufacturer Route Dialysis Drug Level Above Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Therapeutic Lethargy Medication Error Oedema Date:01/16/01ISR Number: 3648770-4Report Type:Expedited (15-DaCompany Report #LBID00201000032 Age:62 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PO PT Report Source Product Role Manufacturer Route Atrophy Bipolar Disorder Foreign Literature Lithobid PS Solvay Pharmaceuticals ORAL Brain Scan Abnormal Mania Tardive Dyskinesia Other Zuklopentixol () Biperiden (Biperiden) C C Date:01/16/01ISR Number: 3648823-0Report Type:Expedited (15-DaCompany Report #A040563 Age: Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Manufacturer Route Atrioventricular Block Sick Sinus Syndrome Foreign Health Zoloft PS Pfizer Pharmaceuticals Inc ORAL Duration 100.00 MG Professional TOTAL DAILY ORAL Lithium Olanzapine Aricept Mirtazapine Unat SS C C C C Date:01/22/01ISR Number: 3652920-3Report Type:Expedited (15-DaCompany Report #2001000611-1 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Agranulocytosis Foreign Health Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Duration ORAL Professional 22-Aug-2005 Page: 285 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/01ISR Number: 3652923-9Report Type:Expedited (15-DaCompany Report #2001000604-1 Age:46 YR Gender: I/FU:I Outcome Dose Duration Death Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Atelectasis Brain Oedema Coma Completed Suicide Heart Rate Increased Hepatic Necrosis Hypernatraemia Hypokalaemia Hyporeflexia Intentional Misuse Leukocytosis Muscle Rigidity Pneumonia Pulmonary Congestion Pulmonary Oedema Purulence Renal Disorder Renal Tubular Disorder Therapeutic Agent Toxicity Foreign Literature Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals Route Date:01/22/01ISR Number: 3652933-1Report Type:Expedited (15-DaCompany Report #LBID00200006014 Age:40 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged DAILY PO, PT Report Source Product Role Manufacturer Route Aggression Anxiety Foreign Literature Lithobid PS Solvay Pharmaceuticals ORAL Condition Aggravated Health Dehydration Professional Drug Ineffective Other 1200 MG DAILY PO, 1400 MG DAILY PO Dysphoria Epilepsy Euphoric Mood Hostility Hypernatraemia Valproic Acid (Valproic Acid) Zuclopenthixol (Zuclopenthixol) Haloperidol C C Hyperparathyroidism Hypocalcaemia Logorrhoea Mania Oral Intake Reduced Polydipsia Polyuria Post Procedural Complication Skin Disorder Date:01/25/01ISR Number: 3653991-0Report Type:Direct Age:69 YR Gender:Male I/FU:I Outcome Life-Threatening 22-Aug-2005 Page: 286 10:48 AM PT Acute Psychosis Balance Disorder Blood Creatine Phosphokinase Increased Blood Creatinine (Haloperidol) Risperidone (Risperidone) Clozapine (Clozapine) Levomepromazine (Levomepromazine) Oxazepam (Oxazepam) Clorazepinic Acid Flurazepam (Flurazepam) Company Report # C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Condition Aggravated Confusional State Oral Intake Reduced Dose Report Source Product Role Haloperidol PS Lithium Carbonate SS Manufacturer Route Route Duration Parkinsonism REFER TO Pneumonia SUMMARY Respiratory Arrest Speech Disorder Date:01/25/01ISR Number: 3656041-5Report Type:Expedited (15-DaCompany Report #2001UW00195 Age:48 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Decreased Appetite Delusion Depression Drug Level Above Therapeutic Electroencephalogram Abnormal Insomnia Intentional Misuse Nervous System Disorder Psychotic Disorder Sinus Tachycardia Suicide Attempt Foreign Literature Health Professional Other Elavil PS Astrazeneca Pharmaceuticals Lp Lithium SS Date:01/29/01ISR Number: 3656866-6Report Type:Expedited (15-DaCompany Report #2001001133-1 Age:41 YR Gender:Unknown I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Coma Convulsion Drug Toxicity Renal Failure Respiratory Failure Shock Literature Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals Route Date:01/29/01ISR Number: 3656869-1Report Type:Expedited (15-DaCompany Report #2001001043-1 Age:52 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 287 10:48 AM PT Report Source Product Role Manufacturer Agitation Blood Albumin Increased Body Temperature Decreased Confusional State Disorientation Drug Level Above Therapeutic Heart Rate Increased Hyperreflexia Hypertonia Intentional Misuse Nausea Literature Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/01ISR Number: 3657967-9Report Type:Expedited (15-DaCompany Report #HQ5204122DEC2000 Age:70 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 200 MG 1X PER Other 1 DAY PT Report Source Product Role Manufacturer Route Agitation Confusional State Foreign Health Effexor PS Wyeth Ayerst Laboratories ORAL Depressed Level Of Professional Consciousness Diarrhoea Drug Interaction Other Modopar (Benserazide Hydrochloride/Levodo pa, ) SS Teralithe (Lithium Carbonate, ) SS Theralene Atarax Avlocardyl C C C 250 MG 1X PER Drug Level Above 1 DAY Therapeutic Fall ORAL 1000 MG 1X Hyperhidrosis PER 1 DAY Hypertonia Logorrhoea Malaise Serotonin Syndrome Tremor Vomiting Date:02/01/01ISR Number: 3658393-9Report Type:Expedited (15-DaCompany Report #2001000611-1 Age:35 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1072 Other MILLIGRAMS 32 DAY PT Report Source Product Role Manufacturer Route Agranulocytosis Haematoma Foreign Health Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Myelodysplastic Syndrome Professional Ciatyl Depot(Zuclopenthixol e) Lyogen Depot (Fluphenazine) C C Date:02/01/01ISR Number: 3660273-XReport Type:Expedited (15-DaCompany Report #WAES 00110445 Age:62 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Confusional State Drug Level Above Therapeutic Health Professional Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL 25 Urinary Tract Infection MG/DAILY/PO Lithium Carbonate (Roxane) 300 Mg SS ORAL 200 MG/TID/PO Date:02/02/01ISR Number: 3660347-3Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1 1/2 TABS PO @ HS / Company Report # PT Report Source Product Role Mental Impairment Health Professional Eskalith (450 Mg Tablets) PS Klonopin Effexor Glucotrol Accupril Pilocarpine Prilosec C C C C C C PTA 22-Aug-2005 Page: 288 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/01ISR Number: 3661501-7Report Type:Periodic Age:7 YR Gender:Male I/FU:I Outcome Dose Duration Other 50 MG BID PO Company Report #FLUV00200006556 PT Report Source Product Role Pain Consumer Luvox PS ORAL Lithobid (Lithium Carbonate) SS ORAL Tremor Vomiting Manufacturer Route 300 MG BID PO Zyprexa (Olanzapine) Risperdal (Risperidone) Date:02/02/01ISR Number: 3701957-4Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose C C Company Report #FLUV00200002752 PT Report Source Product Role Manufacturer Route Abdominal Pain Anorectal Disorder Consumer Luvox PS Solvay Pharmaceuticals ORAL Duration 25MG BID PO, Chills 25 MG QD PO Diarrhoea Lithonate SS ORAL 1200 MG QD Gastrointestinal Disorder PO, 900 MG QD Hernia PO, UNK DAILY Keratoconjunctivitis PO Sicca Pharyngitis Date:02/05/01ISR Number: 3660438-7Report Type:Periodic Age:30 YR Gender:Male I/FU:I Outcome Dose Duration Other 5.00 MG TOTAL Company Report #9952521 PT Report Source Product Role Drug Interaction Health Zyrtec Tablets PS Manufacturer Route ORAL Drug Level Below Professional DAILY ORAL Therapeutic Lithium SS Synthroid C ORAL 1125.00 MG TOTAL TID ORAL Date:02/05/01ISR Number: 3661309-2Report Type:Expedited (15-DaCompany Report #LBID00200006463 Age:37 YR Gender:Male I/FU:F Outcome Dose Duration Death Life-Threatening PO PT Report Source Product Role Manufacturer Route Dermatitis Drug Hypersensitivity Consumer Lithobid PS Solvay Pharmaceuticals ORAL Fatigue Nervousness Overdose Panic Attack Renal Failure Swelling Neuroleptic Medication C Date:02/05/01ISR Number: 3661539-XReport Type:Expedited (15-DaCompany Report #2000037052-1 Age:40 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Leukocytosis Thrombocythaemia Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Granulocyte Colony-Stimulating Factor 22-Aug-2005 Page: 289 10:48 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa (Olanzapine) Ambien (Zolpidem Tartrate) Cogentin (Benztropine Mesylate) Date:02/06/01ISR Number: 3660904-4Report Type:Direct Age:51 YR Gender:Male I/FU:I Outcome Dose PT C C C Company Report # Report Source Product Role Lithium Carbonate (300mg) PS Manufacturer Route Duration Alcoholism Fall ORAL 300MG PO BID Hypotension Medication Error Myocardial Infarction Therapeutic Agent Toxicity Tremor Date:02/09/01ISR Number: 3664384-4Report Type:Expedited (15-DaCompany Report #2001000474-1 Age:10 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged 450 MG 2 PT Report Source Product Role Manufacturer Route Dermatitis Hepatic Failure Infectious Mononucleosis Health Professional Eskalith Cr PS Eskalith SS Smithkline Beecham Pharmaceuticals Smithkline Beecham ORAL ORAL Zyprexa (Olanzapine) Clonidine Adderall Bisperdal (Bisperidone) C C C Pyrexia DAILY ORAL 34 DAY Renal Disorder Date:02/13/01ISR Number: 3664975-0Report Type:Expedited (15-DaCompany Report #A101960 Age:57 YR Gender:Male I/FU:I C Outcome Dose Duration Hospitalization 1000.00 MG Initial or Prolonged TOTAL:TID:ORA PT Report Source Product Role Manufacturer Route Agitation Foreign Lithane Tablets PS ORAL Clonic Convulsion Literature Confusional State Health Coordination Abnormal Professional Captopril SS ORAL Nifedipine Lisinopril C C L 150.00 MG Drug Interaction TOTAL:TID:ORA Drug Level Above L Therapeutic Encephalopathy Haemorrhagic Stroke Hydrocephalus Hypertension Renal Impairment Sedation 22-Aug-2005 Page: 290 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/01ISR Number: 3665059-8Report Type:Direct Age:49 YR Gender:Male I/FU:I Outcome Dose PT Company Report # Report Source Product Role Drug Level Below Agenerase PS Therapeutic Lithium SS Manufacturer Route Manufacturer Route Duration 6 CAPSULES X2 4 PILL DAILY Date:02/16/01ISR Number: 3666101-0Report Type:Direct Age:84 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 150 MG QID Initial or Prolonged PT Company Report # Report Source Product Role Coma Lithium PS Drug Level Above Therapeutic Dysarthria Facial Palsy Hemiparesis Synthroid Prevacid Colace Risperidol Depakote Buspar Donnatal C C C C C C C Date:02/16/01ISR Number: 3667786-5Report Type:Expedited (15-DaCompany Report #2000015366-1 Age:52 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged ORAL 10 YR Other 675 MG 2.0 Required DAILY Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Affective Disorder Agitation Consumer Health Eskalith Cr PS Smithkline Beecham Pharmaceuticals ORAL Anaemia Vitamin B12 Professional Eskalith Smithkline Beecham ORAL SS Deficiency Anger Asthenia Bipolar Disorder Choking Coordination Abnormal Delirium Depakote (Valproate Semisodium) Synthroid (Levothyroxine) Effexor (Venlafaxine C C Delusion Depressed Level Of Consciousness Depression Dialysis Difficulty In Walking Disorientation Drug Toxicity Dysarthria Dysphagia Encephalopathy Faecal Incontinence Fall Hypokalaemia Paranoia Pernicious Anaemia Pneumonia Aspiration Pressure Of Speech Renal Failure Acute Rhinorrhoea Urinary Incontinence Urinary Retention Urinary Tract Infection Wheelchair User 22-Aug-2005 Page: 291 10:48 AM Hydrochloride) Restoril (Famotidine) C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/01ISR Number: 3667793-2Report Type:Expedited (15-DaCompany Report #2001003226-1 Age:60 YR Gender:Male I/FU:I Outcome Dose Other 300 PT Report Source Product Role Manufacturer Route Mania Consumer Lithium Carbonate PS ORAL Prilosec (Omeprazole) SS ORAL Duration MILLIGRAMS 3.0 DAILY ORAL ORAL Zoloft (Sertraline) Ranitidine (Ranitidine Hcl) Buspar (Buspirone Hcl) C C C Date:02/16/01ISR Number: 3668301-2Report Type:Expedited (15-DaCompany Report #A040563 Age: Gender:Female I/FU:F Outcome Dose Duration Required Intervention to 100.00 MG Prevent Permanent TOTAL:DAILY:O Impairment/Damage RAL PT Report Source Product Role Manufacturer Route Atrioventricular Block Sick Sinus Syndrome Foreign Health Zoloft Tablets PS Pfizer Pharmaceuticals Inc ORAL Professional Lithium Olanzapine Aricept Mirtazapine Unat Date:02/16/01ISR Number: 3668368-1Report Type:Expedited (15-DaCompany Report #2001002462-1 Age:39 YR Gender:Female I/FU:I SS C C C C Outcome Dose Duration Hospitalization Initial or Prolonged 1 DAY Other PT Report Source Product Role Manufacturer Agitation Bipolar I Disorder Literature Health Eskalith PS Smithkline Beecham Pharmaceuticals Blood Pressure Decreased Depressed Level Of Consciousness Disorientation Drug Interaction Drug Level Above Therapeutic Intentional Misuse Mania Neuroleptic Malignant Syndrome Oral Intake Reduced Suicide Attempt Tachycardia Vomiting Professional Haloperidol Sulpiride C C Date:02/20/01ISR Number: 3668365-6Report Type:Expedited (15-DaCompany Report #LBID00201000436 Age:34 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 292 10:48 AM PT Abdominal Distension Depression Overdose Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Vomiting Weight Increased Dose Report Source Product Role Manufacturer Route Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 600 MG PO , 1800 MG PO, 2100 MG PO Klonopin (Clonazepam) C Date:02/21/01ISR Number: 3668691-0Report Type:Expedited (15-DaCompany Report #PHBS1996SE02492 Age:33 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG, ORAL PT Report Source Product Role Manufacturer Route Cardiomyopathy Diarrhoea Foreign Health Clozaril PS Novartis Pharmaceuticals Corp ORAL Eosinophilia Headache Hepatic Function Abnormal Neutropenia Pyrexia Professional Other Lithium(Lithium) Truxal Route SS C Date:02/21/01ISR Number: 3668828-3Report Type:Expedited (15-DaCompany Report #A102364 Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Coma Drug Level Above Therapeutic Drug Toxicity Haemodialysis Hypotension Hypotonia Rebound Effect Renal Failure Literature Health Professional Lithane Tablets PS Pfizer Inc Date:02/23/01ISR Number: 3669766-2Report Type:Expedited (15-DaCompany Report #NSADSS2001003698 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged ORAL Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Confusional State Health Risperdal PS Janssen Research Fdn ORAL Delirium Professional Lithium (Lithium) SS Diabetes Insipidus Platelet Count Decreased Thrombotic Thrombocytopenic Purpura Date:02/26/01ISR Number: 3670311-6Report Type:Expedited (15-DaCompany Report #WAES 01020666 Age:44 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 293 10:48 AM PT Balance Disorder Burning Sensation Dialysis Diarrhoea Drug Level Above Therapeutic ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyspnoea Photopsia Dose Report Source Product Role Manufacturer Route Consumer Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL Duration UNK/UNK/PO Lithiumco3 Unk Avandia Celexa Glucotrol Lopid Seroquel Zestril Metoprolol SS C C C C C C C Date:02/26/01ISR Number: 3670865-XReport Type:Expedited (15-DaCompany Report #PHRM2001FR00611 Age:45 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Diabetes Insipidus Diabetes Mellitus Foreign Health Tegretol-Xr PS Novartis Pharmaceuticals Corp ORAL Inadequate Control Professional Drug Withdrawal Syndrome Hypernatraemia Inappropriate Antidiuretic Hormone Secretion Polydipsia Other Duration 400MG, QD, ORAL Date:02/28/01ISR Number: 3676196-6Report Type:Periodic Age:60 YR Gender:Female I/FU:F Outcome Dose Other 25.00 MG Lithium (Lithium) Anxiolytics (No Ingredients/Substanc es) SS C Company Report #9835901 PT Report Source Product Role Manufacturer Route Bone Pain Depression Consumer Health Zoloft PS Pfizer Pharmaceuticals Inc ORAL Duration Dyspepsia Professional TOTAL: DAILY: Hyperhidrosis ORAL Nausea Lithium SS Ibuprofen C 675.00 MG Visual Disturbance TOTAL: DAILY Weight Increased Date:02/28/01ISR Number: 3677281-5Report Type:Periodic Age:27 YR Gender:Female I/FU:I Outcome Dose Other Company Report #A018510 PT Report Source Product Role Manufacturer Route Headache Nausea Health Professional Zoloft PS Pfizer Pharmaceuticals Inc ORAL Duration 100.00 MG Pyrexia TOTAL:ORAL Eskalith SS Klonopin C 300.00 MG TOTAL:TID:ORA L 22-Aug-2005 Page: 294 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3677326-2Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Skin Discolouration Health Professional Company Representative Zoloft PS Pfizer Pharmaceuticals Inc Lithium Wellbutrin SS C Company Report #A004670 PT Report Source Product Role Manufacturer Nausea Vomiting Health Professional Zoloft PS Pfizer Pharmaceuticals Inc Lithium SS Route Duration Date:02/28/01ISR Number: 3677522-4Report Type:Periodic Age:13 YR Gender:Male I/FU:I Outcome Dose Other Route Duration Date:02/28/01ISR Number: 3677358-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #A035493 Company Report #A001056 PT Report Source Product Role Manufacturer Route Abdominal Pain Agitation Health Professional Zoloft PS Pfizer Pharmaceuticals Inc ORAL Duration 25.00 MG Drug Ineffective TOTAL: DAILY Dysgeusia ORAL Hypertonia Lithium SS ORAL Neurontin SS ORAL 300.00 MG Muscle Twitching TOTAL:DAILY:O Myalgia RAL Osteoarthritis 900.00 MG Pain TOTAL:TID:ORA Thinking Abnormal L Vasodilatation Haldol SS Adderall Tenex Claritin C C C ORAL 1.00 MG TOTAL:BID:ORA L Date:03/01/01ISR Number: 3672392-2Report Type:Expedited (15-DaCompany Report #LBID00201000567 Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Bone Marrow Depression Health Professional Lithobid PS Solvay Pharmaceuticals ORAL 900 MG DAILY PO Zoloft (Sertraline Hydrochloride) Synthroid (Levothyroxine Sodium) Gemfibrozil (Gemfibrozil) Procrit (Erythopoietin) 22-Aug-2005 Page: 295 10:48 AM C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/01ISR Number: 3672393-4Report Type:Expedited (15-DaCompany Report #LBID00201000527 Age:81 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Cardiac Pacemaker Insertion Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY Cerebrovascular Accident PO Dysarthria Heart Rate Decreased Muscular Weakness Sular (Nisoldipine) Bladder Medication C C Date:03/02/01ISR Number: 3672944-XReport Type:Expedited (15-DaCompany Report #2000037052-1 Age:40 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 PT Report Source Product Role Manufacturer Route Leukocytosis Psychotic Disorder Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Manufacturer Route Thrombocythaemia MILLIGRAMS , 1.0 DAILY ORAL Granulocyte Colony-Stimulating Factor Zyprexa (Olanzapine) Ambien (Zolpidiem Tartrate) Cogentin(Benztropine Mesylate) Lodine (Etodolac) C C C C C Date:03/06/01ISR Number: 3675613-5Report Type:Expedited (15-DaCompany Report #A104073 Age:64 YR Gender:Male I/FU:I Outcome Dose PT Duration Report Source Product Role Required ORAL Intervention to 300.00 MG Prevent Permanent TOTAL:DAILY:O Impairment/Damage RAL Alanine Aminotransferase Foreign Lithium Carbonate PS Pfizer Inc ORAL Increased Other Ranitidine SS ORAL Nefazodone SS ORAL Olanzapine SS ORAL Aspartate Aminotransferase Increased 300.00 MG Blood Alkaline TOTAL:DAILY:O Phosphatase Increased RAL Blood Lactate DAILY:ORAL Dehydrogenase Increased Gamma-Glutamyltransferase Increased Pyrexia Date:03/09/01ISR Number: 3678213-6Report Type:Expedited (15-DaCompany Report #LBID00201000770 Age:56 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 296 10:48 AM PT Asthenia Confusional State Coordination Abnormal Dizziness Drug Level Above Therapeutic Dysarthria Fall FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nervous System Disorder Renal Impairment Tremor Dose Report Source Product Role Manufacturer Route Foreign Literature Lithobid PS Solvay Pharmaceuticals ORAL Duration Vomiting 1200 MG DAILY Other PO Levofloxacin (Levofloxacin) SS 300 MG DAILY Date:03/12/01ISR Number: 3680592-0Report Type:Expedited (15-DaCompany Report #WAES 00101917 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Drug Interaction Drug Toxicity Renal Disorder Health Professional Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL DAILY/PO Lithobid 300 Mg SS ORAL 300 MG /BID/PO; 300MG/DAILY/P O Date:03/12/01ISR Number: 3680848-1Report Type:Expedited (15-DaCompany Report #17812-124 Age:56 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200MG, PT Report Source Product Role Manufacturer Route Confusional State Coordination Abnormal Foreign Literature Lithium Carbonate PS Roxane Laboratories Inc ORAL Dizziness Health Drug Level Above Professional DAILY, ORAL 300MG, DAILY 2 DAY Levofloxacin SS Therapeutic Dysarthria Fall Nervous System Disorder Renal Impairment Tremor Vomiting Date:03/14/01ISR Number: 3680760-8Report Type:Direct Age:8 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 250 MG / QID Other / ORAL PT Condition Aggravated Enuresis Company Report # Report Source Product Role Valproic Acid / 250mg PS ORAL Lithium SS ORAL Clonidine Risperidone Synthroid Ddavp C C C C 300MG / BID / ORAL Date:03/15/01ISR Number: 3682477-2Report Type:Expedited (15-DaCompany Report #LBID00201000994 Age:25 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 297 10:48 AM PT Electromyogram Abnormal Hypokalaemia Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyporeflexia Paralysis Flaccid Dose 600 MG DAILY Report Source Product Role Manufacturer Literature Health Lithobid PS Solvay Pharmaceuticals Professional Buspirone (Buspirone) Fluoxetine (Fluoxetine) Route Duration 5 YR Date:03/16/01ISR Number: 3681922-6Report Type:Direct Age:64 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization PO BID Initial or Prolonged PT C Company Report # Report Source Product Role Back Pain Lithium (300mg) PS Dry Mouth Synthroid Estrace Ditropan Risperdal Pepcid C C C C C Date:03/16/01ISR Number: 3681975-5Report Type:Direct Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG PO Initial or Prolonged DAILY C PT Body Temperature Increased Drug Level Above Therapeutic Electrocardiogram Change Fatigue Feeling Jittery Hypoaesthesia Mental Impairment Pollakiuria Tremor Manufacturer Route ORAL Company Report # Report Source Product Role Lithium 300mg Po PS Manufacturer Route ORAL Date:03/19/01ISR Number: 3682878-2Report Type:Direct Age:66 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization PO DAILY Initial or Prolonged PT Company Report # Report Source Product Role Anxiety Lithium (450 Mg) PS Confusional State Decreased Appetite Headache Insomnia Tremor Clonidine Lopressor Lipitor Clonazepam Celexa C C C C C Manufacturer Route ORAL Date:03/19/01ISR Number: 3684374-5Report Type:Expedited (15-DaCompany Report #LBID00201000994 Age:25 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG DAILY 5 YR 22-Aug-2005 Page: 298 10:48 AM PT Report Source Product Role Manufacturer Electromyogram Abnormal Hypokalaemia Literature Health Lithobid PS Solvay Pharmaceuticals Hyporeflexia Paralysis Flaccid Professional Buspirone (Buspirone) Fluoxetine C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Fluoxetine) C Date:03/19/01ISR Number: 3684503-3Report Type:Expedited (15-DaCompany Report #A104932 Age:56 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200.00 MG Initial or Prolonged TOTAL:ORAL PT Report Source Product Role Manufacturer Route Blood Creatine Increased Foreign Lithium Carbonate PS Pfizer Inc ORAL Bronchitis Consumer Confusional State Health Levofloxacin SS Coordination Abnormal Professional ORAL 300.00 MG TOTAL:ORAL Creatinine Renal Clearance Decreased Dizziness Drug Interaction Drug Level Above Therapeutic Drug Toxicity Dysarthria Fall Renal Impairment Tremor Vomiting Date:03/19/01ISR Number: 3685630-7Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization LI 6OO MG PO Initial or Prolonged BID PT Catatonia Dehydration Company Report # Report Source Product Role Manufacturer Route Lithium (600mg) (Roxane) PS Roxane ORAL Zestril (20mg) SS Lithium 300 Mg C Drug Level Above Therapeutic ORAL ZESTRIL 20MG Electrocardiogram PO QD Abnormal 300 MG BID Roxane ORAL Lethargy LIQUID Medication Error Date:03/20/01ISR Number: 3685074-8Report Type:Direct Age:57 YR Gender:Male I/FU:I Outcome Dose Duration Other 300 QID Required 300 QID Intervention to Prevent Permanent Impairment/Damage PT Product Role Hypernatraemia Lithium PS Nephrogenic Diabetes Lithium SS 22-Aug-2005 Page: 299 10:48 AM Report Source Manufacturer Route Manufacturer Route Insipidus Date:03/20/01ISR Number: 3685085-2Report Type:Direct Age:79 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 450MG AT HS Initial or Prolonged Company Report # PT Asthenia Drug Toxicity Renal Impairment Tremor Company Report # Report Source Product Role Lithium PS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/01ISR Number: 3685087-6Report Type:Direct Age:46 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1 AT NOON, 3Q PT Company Report # Report Source Circulatory Collapse Confusional State Product Role Lithium (300mg In Am) PS Manufacturer Route Route Coordination Abnormal HS Disorientation Drug Level Above Therapeutic Muscle Rigidity Speech Disorder Date:03/20/01ISR Number: 3686404-3Report Type:Expedited (15-DaCompany Report #2001006204-1 Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 750 PT Report Source Product Role Manufacturer Chest Pain Drug Toxicity Literature Health Eskalith PS Smithkline Beecham Pharmaceuticals Electrocardiogram T Wave Professional MILLIGRAMS Inversion Sinus Bradycardia Date:03/21/01ISR Number: 3687358-6Report Type:Expedited (15-DaCompany Report #2001006495-1 Age:64 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Balance Disorder Dizziness Electrocardiogram Abnormal Photopsia Sinus Arrhythmia Supraventricular Extrasystoles Literature Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals Duration Route Date:03/22/01ISR Number: 3687952-2Report Type:Expedited (15-DaCompany Report #WAES 01031627 Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Drug Interaction Drug Toxicity Health Professional Company Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL UNK / UNK / Representative PO Lithiumco3 SS Date:03/22/01ISR Number: 3687991-1Report Type:Expedited (15-DaCompany Report #NSADSS2001006935 Age:38 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 2 MG, 2 IN 1 Initial or Prolonged DAY(S), ORAL Disability 900 MG, PT Report Source Product Role Manufacturer Route Drug Level Above Consumer Risperdal PS Janssen Research Fdn ORAL Lithium (Lithium) SS Therapeutic Pneumonia Tongue Disorder DAILY, ORAL Tremor 22-Aug-2005 Page: 300 10:48 AM Synthroid (Levothyroxine Sodium) Cogentin C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Benzatropine Mesilate) Neurontin (Gabapentin) Depakote (Valproate Semisodium) C C C Date:03/22/01ISR Number: 3688189-3Report Type:Expedited (15-DaCompany Report #2001006525-1 Age:80 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 PT Report Source Product Role Manufacturer Route Abdominal Pain Upper Akinesia Literature Health Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Blood Creatinine Professional MILLIGRAMS Increased Blood Potassium Decreased Blood Sodium Increased Blood Uric Acid Increased Bradycardia Cardiac Disorder Dehydration Depressed Level Of Consciousness Difficulty In Walking Disturbance In Attention Drug Level Above Therapeutic Drug Toxicity Dysarthria Extrapyramidal Disorder Haematocrit Increased Haemoglobin Increased Hepatitis Hypotension Leukocytosis Metabolic Acidosis Muscle Rigidity Nausea Pancreatitis Paresis Sedation Sinus Arrhythmia Sinus Bradycardia Acetylsalicylic Acid Isosorbital Dinitrate Theophylline Thiazide Diuretic (Nos) Trimipramine C C C C C Tachypnoea Urinary Retention Date:03/23/01ISR Number: 3705663-1Report Type:Periodic Age:56 YR Gender:Female I/FU:I Outcome Dose Company Report #WAES 01020184 PT Report Source Product Role Manufacturer Route Drug Level Above Therapeutic Health Professional Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL Duration PO Lithiumco3 22-Aug-2005 Page: 301 10:48 AM SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/01ISR Number: 3705674-6Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Company Report #WAES 00120968 PT Report Source Product Role Manufacturer Route Drug Toxicity Muscular Weakness Pain Consumer Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL Duration PO Lithium-Duriles Ambien Singulair (Therapy Unspecified) Doxepin SS C C C C Date:03/26/01ISR Number: 3689883-0Report Type:Expedited (15-DaCompany Report #ZONI000389 (0) Age:17 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged 700 MG DAILY Required ORAL Intervention to 1800 MG DAILY Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Drug Interaction Drug Toxicity Haemodialysis Health Professional Zonegran PS Dainippon Pharmaceutical Usa Corp ORAL Renal Impairment Lithium (Lithium) SS Topamax Seroquel C C Date:03/26/01ISR Number: 3690166-3Report Type:Expedited (15-DaCompany Report #1999004849NL Age:72 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 2 MG QD ORAL PT Report Source Product Role Manufacturer Route Arrhythmia Cardiomyopathy Foreign Health Detrol PS Pharmacia And Upjohn Co ORAL Cardiovascular Disorder Dizziness Professional Other Theolin - Slow Release UNKNOWN UNK UNKNOWN UNKNOWN UNKNOWN Malaise 300 MG BID Nausea 8 DAY Pulse Pressure Decreased Syncope 25 MG TID 8 DAY Tremor Urinary Incontinence 400 MG BID 8 DAY Urinary Retention Ventricular Tachycardia 8 DAY (Theophylline) SS Clomipramine (Clomipramine) SS Priadel (Lithium Carbonate) SS Ventoline (Salbutamol) SS Zestril (Lisinopril) Aspirine Acetylcysteine C C C Date:03/27/01ISR Number: 3691107-5Report Type:Expedited (15-DaCompany Report #2001006729-1 Age:75 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 302 10:48 AM PT Report Source Product Role Manufacturer Bradycardia Drug Level Above Therapeutic Nodal Arrhythmia Sinus Arrest Sinus Arrhythmia Supraventricular Extrasystoles Vomiting Literature Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals Carbamazepine Haloperidol C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/27/01ISR Number: 3691108-7Report Type:Expedited (15-DaCompany Report #2001006210-1 Age:13 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2400 PT Report Source Product Role Manufacturer Cardiac Failure Congestive Literature Health Eskalith PS Smithkline Beecham Pharmaceuticals Cardiomyopathy Professional Imipramide C Route MILLIGRAMS Chest Pain Drug Level Above Therapeutic Drug Level Below Therapeutic Dyspnoea Ejection Fraction Abnormal Fatigue Heart Rate Increased Hepatomegaly Hyperhidrosis Hypothyroidism Mitral Valve Incompetence Oedema Pallor Pulmonary Oedema Rales Respiratory Distress Respiratory Rate Increased Ventricular Extrasystoles Weight Decreased Date:03/28/01ISR Number: 3691190-7Report Type:Expedited (15-DaCompany Report #01P-163-0104719-00 Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization PER ORAL Initial or Prolonged YR PT Report Source Product Role Manufacturer Route Chronic Obstructive Health Kaletra PS Abbott Laboratories ORAL Airways Disease Exacerbated Delirium Tremens Professional Amprenavir Lithium (Lithium) (Lithium) SS SS Drug Interaction Metabolic Acidosis Pulmonary Oedema Coumadin (Warfarin Sodium) (Warfarin Sodium) 11 MG, 1 IN 1 Renal Tubular Acidosis D, PER ORAL Respiratory Alkalosis Date:03/28/01ISR Number: 3692387-2Report Type:Expedited (15-DaCompany Report #2001006888-1 Age:57 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 303 10:48 AM PT Asthenia Atrial Fibrillation Bradycardia Cardiac Arrest Chest Pain Grandiosity Hyperhidrosis Hypomania Loss Of Consciousness Myocardial Infarction Nausea SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syncope Tachycardia Dose Report Source Product Role Manufacturer Literature Health Eskalith PS Smithkline Beecham Pharmaceuticals Route Duration 900 Professional MILLIGRAMS 4 YR Date:03/28/01ISR Number: 3692390-2Report Type:Expedited (15-DaCompany Report #2001006648-1 Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Bradycardia Drug Level Above Therapeutic Sinus Arrest Sinus Arrhythmia Syncope Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals Carbamazepine Cogentin Haloperidol C C C Route Date:03/28/01ISR Number: 3692397-5Report Type:Expedited (15-DaCompany Report #2001006659-1 Age:75 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 PT Report Source Product Role Manufacturer Chorea Coordination Abnormal Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals Drug Level Above MILLIGRAMS Therapeutic Dysarthria Electrocardiogram T Wave Inversion Sinus Arrhythmia Sinus Bradycardia Date:03/28/01ISR Number: 3692399-9Report Type:Expedited (15-DaCompany Report #2001006738-1 Age:40 YR Gender:Male I/FU:I Route Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Atrioventricular Block Complete Dysarthria Heart Rate Irregular Mania Nausea Sedation Sinus Bradycardia Toxicologic Test Abnormal Vomiting Literature Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals Route Date:03/29/01ISR Number: 3692517-2Report Type:Expedited (15-DaCompany Report #01-0459 Age:29 YR Gender:Male I/FU:I Outcome Dose Death PT INTRAMUSCULAR 1 DAY, IM ORAL Aggression Blood Alcohol Increased 50 MG 1 X PER Condition Aggravated 1 DAY Drug Ineffective 1 DAY Head Injury Pulmonary Embolism 40 MG 1 X PER 22-Aug-2005 Page: 304 Report Source Product Role Manufacturer Foreign Health Loxitane Im PS Watson Laboratories Inc Company Alcohol (Ethanol) SS Representative Bromazepam Lysanxia (Prazepam) SS SS Route Duration 10:48 AM Professional ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 DAY RECTAL ONE VIAL Marijuana (Cannabis) SS Netux (Codeine/Phenyltolox amine) Rivotril (Clonazepam) SS Solian (Amisulpride) SS Teralithe (Lithium Carbonate) SS Tercian (Cyamemazine) SS INHALATION 1 SS DAY 400 MG 1 X PER 1 DAY, ORAL 400 MG 3 X PER 1 DAY, ORAL ONE VIAL 1 DAY Date:04/02/01ISR Number: 3694324-3Report Type:Expedited (15-DaCompany Report #2001004210-1 Age:53 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Loss Of Consciousness Narcolepsy Health Professional Eskalith Cr PS Smithkline Beecham Pharmaceuticals Route Duration 450 Road Traffic Accident MILLIGRAMS Sedation 3.0 DAILY Date:04/03/01ISR Number: 3695596-1Report Type:Expedited (15-DaCompany Report #2001006666-1 Age:65 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization - PT Report Source Product Role Manufacturer Atrioventricular Block Literature Eskalith PS Smithkline Beecham Route Initial or Prolonged SEE IMAGE First Degree Health Electrocardiogram Qt Prolonged Electrocardiogram T Wave Amplitude Decreased Hypokalaemia Hypotension Lethargy Sinus Bradycardia Syncope Tardive Dyskinesia Torsade De Pointes Urinary Incontinence Professional Benztropine Mesylate Haloperidol Temazepam Thioridazine Pharmaceuticals ORAL C C C C Date:04/04/01ISR Number: 3696995-4Report Type:Expedited (15-DaCompany Report #NSADSS2001005642 Age: Gender:Unknown I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required SEE IMAGE Intervention to 900 MG, 2 IN Prevent Permanent 1 DAILY Impairment/Damage 22-Aug-2005 Page: 305 10:48 AM PT Report Source Product Role Manufacturer Route Dialysis Dizziness Drug Toxicity Health Professional Topamax PS Rw Johnson Pharmaceutical Research Institute ORAL Speech Disorder Lithium (Lithium) SS Zonisamide (Zonisamide) C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/01ISR Number: 3697042-0Report Type:Expedited (15-DaCompany Report #A035541 Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 150.00 MG PT Report Source Product Role Manufacturer Route Chills Clonic Convulsion Foreign Health Zoloft PS Pfizer Pharmaceuticals Inc ORAL Electroencephalogram Professional TOTAL:DAILY:O Normal RAL Serotonin Syndrome Lithium SS Buspirone Bromazepam Meprobamate + Aceprometazine Zolpidem C C ORAL 750.00 MG Sleep Disorder TOTAL:TID:ORA L C C Date:04/04/01ISR Number: 3697228-5Report Type:Expedited (15-DaCompany Report #2001046151FR Age:77 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 200 MG, QD, Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Coordination Abnormal Foreign Celebrex PS Gd Searle And Co ORAL Drug Interaction Health Fall Malaise Professional Other Teralithe (Lithium Carbonate) SS Prothiaden Sermion C C 250 MG, BID, Overdose ORAL Date:04/05/01ISR Number: 3696975-9Report Type:Direct Age:30 YR Gender:Male I/FU:I Company Report # ORAL Outcome Dose Other PT Report Source Product Role Manufacturer Route Lithobid 300mg (Mfg: Solvay) PS Solvay ORAL Duration Pruritus Urticaria ONE TAB Q AM 300 MG (ORAL); TWO TABS Q HS 300 MG Date:04/06/01ISR Number: 3700172-8Report Type:Expedited (15-DaCompany Report #LBID00201001421 Age:83 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG DAILY PT Report Source Product Role Manufacturer Route Blood Pressure Diastolic Decreased Literature Health Lithobid PS Solvay Pharmaceuticals ORAL Blood Urea Increased Professional PO 1200 MG Drug Level Above DAILY PO Therapeutic Hypothermia Clonazepam (Clonazepam) SS ORAL Lethargy Olanzapine SS ORAL Mental Impairment Oedema Peripheral Oral Intake Reduced Platelet Count Decreased Piroxicam (Piroxicam) Trazodone Hydrochloride (Trazodone Hydrochloride) Lactulose (Lactulose) 1 MG QD PO 5 MG QD PO 22-Aug-2005 Page: 306 10:48 AM C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sulfamethoxazole (Sulfamethoxazole) Trimethoprim (Trimethoprim) C C Date:04/06/01ISR Number: 3700179-0Report Type:Expedited (15-DaCompany Report #2001007381-2 Age: Gender:Female I/FU:I Outcome Dose Duration Death Other INTRA-UTERINE 900 PT Report Source Product Role Manufacturer Ascites Caesarean Section Literature Health Eskalith PS Smithkline Beecham Pharmaceuticals Cardio-Respiratory Arrest Professional Pre-Natal Vitamins C MILLIGRAMS Neonatal INTERUTERINE Complications Of Maternal (SEE IMAGE) Exposure To Therapeutic Drugs Congenital Aortic Valve Incompetence Congenital Jaw Malformation Congenital Mitral Valve Incompetence Congenital Pulmonary Valve Disorder Developmental Delay Foetal Distress Syndrome Limb Malformation Neonatal Apnoeic Attack Oedema Pericardial Effusion Pleural Effusion Pregnancy Small For Dates Baby Tricuspid Valve Incompetence Date:04/06/01ISR Number: 3700227-8Report Type:Expedited (15-DaCompany Report #2001003226-1 Age:60 YR Gender:Male I/FU:F Route Outcome Dose Other PT Report Source Product Role Manufacturer Route Drug Interaction Drug Level Below Consumer Health Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Therapeutic Professional Duration 300 MILLIGRAMS Mania 3.0 DAILY ORAL Prilosec (Omeprazole) SS Zoloft Ranitidine Buspar C C C ORAL Date:04/06/01ISR Number: 3700652-5Report Type:Expedited (15-DaCompany Report #2001007676-1 Age:37 YR Gender:Female I/FU:I Outcome Other 22-Aug-2005 Page: 307 PT Cognitive Disorder Confusional State Delirium 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Delusion Of Grandeur Dementia Depersonalisation Report Source Product Role Manufacturer Route Disorientation Disturbance In Attention Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Manufacturer Route Duration 900 Electroencephalogram MILLIGRAMS Abnormal Flight Of Ideas Hallucinations, Mixed Memory Impairment Mood Altered Renal Impairment Restlessness Urinary Incontinence Date:04/12/01ISR Number: 3703926-7Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Other PT Company Report # Report Source Product Role Lithium Benztropine PS C Duration Acne Cystic Date:04/16/01ISR Number: 3705888-5Report Type:Expedited (15-DaCompany Report #2001008586-1 Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 PT Report Source Product Role Manufacturer Route Condition Aggravated Keratosis Follicular Foreign Literature Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Mania Health Seborrhoea Professional MILLIGRAMS ORAL Other Maprotiline C Date:04/17/01ISR Number: 3706303-8Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose PT Company Report # Report Source Product Role Manufacturer Route Lithium / 300mg / Roxane PS Roxane ORAL Zestril 10 Mg Astrazenica SS Astrazenica ORAL Duration Drug Interaction Drug Level Above 300 MG TID Therapeutic ORAL Medication Error 10 MG DAILY ORAL Date:04/17/01ISR Number: 3707186-2Report Type:Expedited (15-DaCompany Report #FLUV00301000004 Age:34 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Blood Alkaline Phosphatase Increased Foreign Health Luvox PS Solvay Pharmaceuticals ORAL Fall Professional Gamma-Glutamyltransferase Other Duration 150 MG DAILY PO Linton (Haloperidol) SS ORAL Hirnamin (Levomepromazine) SS ORAL 12 MG DAILY Increased PO Injury Loss Of Consciousness 200 MG DAILY PO Anafranil (Clomipramine 22-Aug-2005 Page: 308 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS ORAL Tegretol (Carbamazepine) SS ORAL Limas (Lithium Carbonate) SS ORAL 150 MG DAILY PO 800 MG DAILY PO 1200 MG DAILY PO Date:04/17/01ISR Number: 3707967-5Report Type:Expedited (15-DaCompany Report #01P-163-0104719-00 Age:42 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization PER ORAL Initial or Prolonged PT Report Source Product Role Manufacturer Route Chronic Obstructive Health Kaletra PS Abbott Laboratories ORAL Airways Disease Exacerbated Delirium Tremens Drug Interaction Dyspnoea Pulmonary Oedema Renal Tubular Acidosis Respiratory Alkalosis Professional Amprenavir Lithium (Lithium) (Lithium) SS Date:04/19/01ISR Number: 3708109-2Report Type:Expedited (15-DaCompany Report #LBID00201001744 Age:85 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged PT Anorexia Apraxia Blood Alkaline Phosphatase Increased Blood Chloride Increased Blood Magnesium Decreased Blood Potassium Increased Blood Sodium Increased Blood Thyroid Stimulating SS Hormone Decreased Cheyne-Stokes Respiration Coma Condition Aggravated Confusional State Dehydration Depression Drug Level Above Therapeutic Drug Toxicity Drug Withdrawal Syndrome Electrocardiogram Qt Corrected Interval Prolonged Grandiosity Granuloma Hepatic Encephalopathy International Normalised Ratio Increased Keratitis Herpetic Meningitis Muscle Rigidity Myocardial Infarction Myocardial Ischaemia 22-Aug-2005 Page: 309 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Nephrogenic Diabetes Insipidus Neutrophil Count Report Source Product Role Manufacturer Route Increased Pupil Fixed Literature Health Lithobid PS Solvay Pharmaceuticals ORAL Uveitis White Blood Cell Count Increased Professional Divalproex Sodium (Divalproex Sodium) Thioridazine (Thioridazine) Oxybutynin (Oxybutynin) Probantheline Erythromycin (Erythromycin) Temazepam (Temazepam) Levothyroxine (Levothyroxine) Duration 150 MG BID PO Date:04/23/01ISR Number: 3709751-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 C C C C C C C Company Report #2001000383-1 PT Report Source Product Role Manufacturer Route Condition Aggravated Drug Toxicity Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Manufacturer Route Mental Disorder MILLIGRAMS, ORAL Date:04/24/01ISR Number: 3709261-5Report Type:Direct Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Required Intervention to 300MG PO TID Prevent Permanent PT Company Report # Report Source Product Role Coma Depressed Level Of Lithium Carb. (300mg Caps) PS Consciousness Clonazepam C ORAL Impairment/Damage Drug Level Above Therapeutic Sedation Date:04/24/01ISR Number: 3710199-8Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 225MG PO BID Hospitalization 30 YRS OF Initial or Prolonged LITHIUM USE 30 YR 22-Aug-2005 Page: 310 10:48 AM PT Memory Impairment Depakote Colace Fosinopril Gabapentin Hctz Levothyroxine Lorazepam Miconazole Powder Mom Olanzepine Nifedipine C C C C C C C C C C C Company Report # Report Source Product Role Lithium PS Synthroid Lithium Carbonate Ferrous Sulfate Flomax C C C C Speech Disorder Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Baycol Date:04/24/01ISR Number: 3710201-3Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged PT Outcome Dose Company Report # Report Source Coma Rhabdomyolysis Date:04/24/01ISR Number: 3710204-9Report Type:Direct Age: Gender:Male I/FU:I PT C Product Role Lithium PS Manufacturer Route Manufacturer Route Company Report # Report Source Product Role Lithium PS Pyridium Pepcid Metoprolol Hydralazine Avandia Amlodipine Divalprovex Insulin Oxybutynin Actron C C C C C C C C C C Duration Cardiac Failure ORAL 300MG 2 Congestive TABLETS BID Diabetes Mellitus PO Drug Toxicity Mental Impairment Pulmonary Oedema Renal Failure Acute Date:04/24/01ISR Number: 3710496-6Report Type:Direct Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Drug Toxicity Rhabdomyolysis Company Report # Report Source Product Role Lithium Sertraline Clonazepam PS C C Manufacturer Route Zyprexa Date:04/24/01ISR Number: 3710497-8Report Type:Direct Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Depressed Level Of Consciousness Drug Toxicity Lethargy Loss Of Consciousness Company Report # Report Source Product Role Lithium Diltizem Estrogens Pepcid Neurontin Levothyroxine Colace PS C C C C C C Date:04/25/01ISR Number: 3710668-0Report Type:Expedited (15-DaCompany Report #C2001-0972.01 Age: Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 311 10:48 AM PT Constipation Decreased Activity Depressed Level Of C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Consciousness Hyperreflexia Hypothermia Lethargy Report Source Product Role Manufacturer Route Mental Impairment Oedema Peripheral Literature Other Clonazepam PS Mylan Pharmaceuticals Inc ORAL Duration 1 MG QD, ORAL Oral Intake Reduced Lithium SS Olanzapine Lilly SS Piroxicam Sulfamethoxazole/Tri methoprim C ORAL 300 MG BID Social Avoidant Behaviour AND 600 MG QHS, ORAL Lilly ORAL 5 MG QD, ORAL C Date:04/25/01ISR Number: 3710919-2Report Type:Expedited (15-DaCompany Report #WAES 01031627 Age:69 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Abdominal Pain Balance Disorder Blood Pressure Increased Health Professional Company Vioxx PS Merck Research Laboratories Div Merck Co Inc ORAL Confusional State Representative Lithiumco3 300 Mg SS Fosamax Lortab Prempro Prevacid Zestril C C C C C PO DAILY Drug Interaction Drug Toxicity Gait Disturbance Haematocrit Decreased Haemoglobin Decreased Hallucination Headache Memory Impairment Mental Impairment Oliguria Peripheral Sensory Neuropathy Pollakiuria Sedation Speech Disorder Thirst Tremor Visual Acuity Reduced Weight Decreased Date:04/26/01ISR Number: 3711545-1Report Type:Direct Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 255 MG TID Initial or Prolonged AND 450 HS PT Blood Creatinine 10:48 AM Report Source Product Role Lithium PS Depakote Er Synthroid Clozaril Haldol Allopurinol Glucophage Flomax C C C C C C C Increased Cough Diabetes Insipidus Lethargy Mental Impairment Oral Intake Reduced Pyrexia 22-Aug-2005 Page: 312 Company Report # Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/27/01ISR Number: 3712931-6Report Type:Direct Age:45 YR Gender:Male I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Bradycardia Dizziness Nausea Vomiting Product Role Lithium Atropine Rosiglitazone Medisense Precision Qid Strips Nortriptyline Diltiazem Gemfibrozil Insulin 70/30 Insulin Syringe Isopropyl Alcohol Lancets Lithium Carbonate Maxzide Olanzapine Terazosin Hcl Lisinopril Isopropyl Alcohol Lancets Lithium Carbonate Maxzide Olanzapine Terazosin Hcl Lisinop PS C C C C C C C C C Manufacturer Route Route C C Date:04/30/01ISR Number: 3714306-2Report Type:Expedited (15-DaCompany Report #033-0982-M0100006 Age: Gender:Male I/FU:I Outcome Dose Duration Life-Threatening INTRAVENOUS PT Report Source Product Role Manufacturer Foreign Consumer Cerebyx PS Parke Davis Div Warner Lambert Co Hypotension Overdose Daonil (Glibenclamide) SS ORAL Sinus Bradycardia Terlithe (Lithium Carbonate) SS ORAL Lovenox (Heparin F-Raction, Sodium Salt) C Coma Drug Level Above 1200 MG, Therapeutic Other INTRAVENOUS PER ORAL PER ORAL Augmentin Injection (Amoxicillin Sodium, Clavulanate Potassium) Actrapid (Insulin) C C Date:04/30/01ISR Number: 3715011-9Report Type:Expedited (15-DaCompany Report #01-0459 FOLLOW-UP Age:29 YR Gender:Male I/FU:F Outcome Dose Death PT Report Source Product Role Manufacturer Foreign Health Loxitane Im PS Watson Laboratories Inc Company Alcohol (Ethanol) SS Representative Bromazepam (Bromazepam) Lysanxia (Prazepam) SS SS Marijuana (Cannabis) SS INTRAMUSCULAR 1 DAY, IM ORAL Abnormal Behaviour Aggression 50 MG 1 X PER Agitation 1 DAY Alcoholism 1 DAY Drug Abuser Drug Ineffective Head Injury Professional 40 MG 1 X PER Toxicologic Test Abnormal 1 DAY RESPIRATORY (INHALATION) INHALATION 1 DAY Netux 22-Aug-2005 Page: 313 Route Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Codeine/Phenyltolox amine) Rivotril (Clonazepam) ONE VIAL 1 SS SS DAY Solian (Amisulpride) SS Teralithe (Lithium Carbonate) SS Tercian (Cyamemazine) SS 400 MG 1 X PER 1 DAY, ORAL 400 MG 3 X PER 1 DAY, ORAL ONE VIAL 1 DAY Date:05/03/01ISR Number: 3717245-6Report Type:Expedited (15-DaCompany Report #1818977-2001-00264 Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 PT Report Source Product Role Manufacturer Route Blood Alkaline Phosphatase Increased Foreign Literature Proloprim PS Monarch Pharmaceuticals Inc ORAL Blood Creatinine MG/DAILY/ORAL Increased Lithium Carbonate SS Olanzapine Diazepan Oxazepam C C C 1200 MG /D Diarrhoea AILY/ORAL Disturbance In Attention Drug Level Above Therapeutic Gait Disturbance Malaise Movement Disorder Tremor Urinary Tract Infection ORAL Date:05/03/01ISR Number: 3717553-9Report Type:Expedited (15-DaCompany Report #NSADSS2001003698 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization ORAL Initial or Prolonged ORAL Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Confusional State Health Risperdal PS Janssen Research Fdn ORAL Delirium Professional Lithium (Lithium) SS ORAL Diabetes Insipidus Thrombotic Thrombocytopenic Purpura Date:05/04/01ISR Number: 3716894-9Report Type:Expedited (15-DaCompany Report #259433 Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 314 10:48 AM PT Granuloma Hepatic Fibrosis Hepatic Necrosis Hepatic Steatosis Hepatitis Report Source Product Role Manufacturer Rivotril Laroxyl Depamide Tiapridal Seropram Lithium PS SS SS SS SS SS Roche Roche Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/04/01ISR Number: 3716903-7Report Type:Expedited (15-DaCompany Report #259430 Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 9 DAY PT Report Source Product Role Manufacturer Alanine Aminotransferase Increased Rivotril Isoptine PS SS Roche Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Gamma-Glutamyltransferase Increased Teralithe Innohep Opium Tincture SS SS SS Route Date:05/07/01ISR Number: 3718784-4Report Type:Expedited (15-DaCompany Report #259430 Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 6 MG ORAL PT Report Source Product Role Manufacturer Route Alanine Aminotransferase Increased Foreign Other Clonopin PS Hoffmann La Roche Inc ORAL Aspartate Aminotransferase Increased Isoptine (Verapamil Hydrochloride) 240 Mg SS ORAL Teralithe (Lithium Carbonate) 400 Mg SS ORAL Innohep (Tinzaparin Sodium) 2500 Iu SS Opium Tincture (Opium Tincture) SS 120 MG 1 PER Blood Alkaline DAY ORAL Phosphatase Increased Gamma-Glutamyltransferase 200 MG 1 PER Increased DAY ORAL SUBCUTANEOUS ORAL SUBCUTANEOUS ORAL Date:05/07/01ISR Number: 3718809-6Report Type:Expedited (15-DaCompany Report #259433 Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Blood Glucose Increased Granulomatous Liver Foreign Other Clonopin PS Hoffmann La Roche Inc ORAL Disease Hepatic Fibrosis Hepatic Necrosis Laroxyl (Amitriptyline Hydrochloride) SS ORAL Hepatic Steatosis Hepatitis Depamide (Valpromide) SS ORAL Tiapridal (Tiapride) SS ORAL Seropram (Citalopram) SS ORAL Lithium (Lithium Nos) SS ORAL ORAL ORAL ORAL ORAL ORAL Date:05/08/01ISR Number: 3719128-4Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Other 300 MG 2 PO PT Report Source Product Role Lithobid 300 Mg Bid PS Manufacturer Route Duration Dermatitis Diarrhoea BID Eczema Vomiting 22-Aug-2005 Page: 315 Company Report # 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/01ISR Number: 3723723-6Report Type:Expedited (15-DaCompany Report #PHEH1990US01495 Age:17 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening Hospitalization SEE IMAGE Initial or Prolonged PT Report Source Product Role Manufacturer Route Accident Coma Health Professional Clozaril PS Novartis Pharmaceuticals Corp ORAL Route Convulsion Coordination Abnormal Dermatitis Encephalopathy Fall Head Injury Lithium(Lithium) Haldol (Haloperidol) (Haloperidol) Artane (Trihexypenidyl Hydrochloride SS Hypotension Thorazine SS SS SS "HIGH DOSE" HIGH DOSE Loss Of Consciousness UNK Nephropathy Toxic Orthostatic Hypotension Pyrexia Simple Partial Seizures Syncope Tachycardia White Blood Cell Count Increased Date:05/14/01ISR Number: 3723940-5Report Type:Expedited (15-DaCompany Report #S01-FRA-00867-01 Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged UNKNOWN PT Report Source Product Role Manufacturer Granuloma Hepatic Fibrosis Foreign Health Celexa PS Forest Laboratories Inc Hepatic Necrosis Hepatic Steatosis Professional Other Depamide (Valpromide) SS Laroxyl (Amitriptyline Hydrochloride) SS UNKNOWN UNKNOWN Rivotril (Clonazepam) SS Tiapridal (Tiapride) SS Lithium SS UNKNOWN UNKNOWN UNKNOWN Date:05/14/01ISR Number: 3724104-1Report Type:Expedited (15-DaCompany Report #2001010454-1 Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 4500 Other MILLIGRAMS PT Report Source Product Role Manufacturer Accommodation Disorder Bradycardia Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals Drug Toxicity Intentional Misuse Muscle Spasms Sedation Vomiting Date:05/17/01ISR Number: 3724419-7Report Type:Direct Age: Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 316 10:48 AM PT Blood Creatinine Increased Blood Sodium Increased Coma Company Report # Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diabetes Insipidus Report Source Dose Product Role Lithium PS Zyprexa C Manufacturer Route Duration ORAL 300 MG QD PO Date:05/18/01ISR Number: 3724571-3Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300 MG PO BID Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Product Role Acalculia Lithium PS Asthenia Clonic Convulsion Cognitive Disorder Difficulty In Walking Drug Level Above Therapeutic Fall Intention Tremor Memory Impairment Tremor Urinary Incontinence Prednisone Bactrim Mn Nystatin Imuran Cya Actigall Mg Ox Acyclovir Inderal Lasix Zantac C C C C C C C C C C C C Manufacturer Route ORAL Date:05/18/01ISR Number: 3726310-9Report Type:Expedited (15-DaCompany Report #LBID00201002158 Age:26 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG PO PT Report Source Product Role Manufacturer Route Amnesia Confusional State Consumer Lithobid PS Solvay Pharmaceuticals ORAL Disturbance In Social Behaviour Speech Disorder Seroquel (Seroquel) Lorazepam (Lorazepam) C C Date:05/22/01ISR Number: 3727647-XReport Type:Expedited (15-DaCompany Report #HQ6750129NOV1999 Age:40 YR Gender:Female I/FU:F Outcome Dose Death PT Report Source Product Role Manufacturer Route Arrhythmia Drug Interaction Health Professional Effexor Xr PS Wyeth Ayerst Laboratories ORAL Drug Level Above Other Duration 300 MG 1X PER 1 DAY Therapeutic Sudden Death Dromyl (Dimenhydrinate, ) SS Lithium (Lithium, ) SS Nozinan (Levomepromazine, ) SS "LARGE DOSE" 300 MG 2X PER 1 DAY 9 DAY MAXIMUM 20 MG AT BEDTIME 9 DAY Date:05/23/01ISR Number: 3728079-0Report Type:Expedited (15-DaCompany Report #A110876 Age:47 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Required Intervention to 22-Aug-2005 Page: 317 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage Dose PT Report Source Product Role Manufacturer Route Abdominal Distension Amnesia Foreign Consumer Pfi-Lith PS Pfipharmecs Div Pfizer Inc ORAL Duration 1200.00 MG Arthritis TOTAL: ORAL Breast Engorgement Bronchitis Acute Diarrhoea Difficulty In Walking Drug Level Above Therapeutic Drug Toxicity Eyelid Oedema Haemodialysis Hair Disorder Pruritus Sertraline Levothyroxine Clonazepam Lansoprazole Conjugated Estrogens Morphine Hydromorphone C C C C C C C Date:05/24/01ISR Number: 3728570-7Report Type:Expedited (15-DaCompany Report #HQ6750129NOV1999 Age:40 YR Gender:Female I/FU:F Outcome Dose Death PT Report Source Product Role Manufacturer Route Arrhythmia Drug Interaction Health Professional Effexor Xr PS Wyeth Ayerst Laboratories ORAL Drug Level Above Other Duration 300 MG 1X PER 1 DAY ORAL Therapeutic Sudden Death Diphenhydramine (Diphenydramine) SS Lithium (Lithium) SS Nozinan (Levomepromazine) SS Methotrimeprazine (Levomepromazine) C "LARGE DOSE" 300 MG 2X PER 1 DAY 9 DAY MAXIMUM 20 MG AT BEDTIME Date:05/25/01ISR Number: 3729185-7Report Type:Expedited (15-DaCompany Report #A111268 Age: Gender:Unknown I/FU:I Outcome Dose Death ORAL PT Report Source Product Role Manufacturer Route Intentional Misuse Foreign Lithium Carbonate PS Pfizer Inc ORAL Literature Ssri Unspecified SS Duration ORAL ORAL Health Professional Date:05/25/01ISR Number: 3729186-9Report Type:Expedited (15-DaCompany Report #A111269 Age: Gender:Unknown I/FU:I Outcome Dose Death ORAL PT Report Source Product Role Manufacturer Route Intentional Misuse Foreign Lithium Carbonate PS Pfizer Inc ORAL Literature Ssri Unspecified SS Duration ORAL Health Professional 22-Aug-2005 Page: 318 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/01ISR Number: 3729188-2Report Type:Expedited (15-DaCompany Report #A111270 Age: Gender:Unknown I/FU:I Outcome Dose Death ORAL PT Report Source Product Role Manufacturer Route Intentional Misuse Foreign Lithium Carbonate PS Pfizer Inc ORAL Literature Ssri Unspecified SS Duration ORAL ORAL Health Professional Date:05/25/01ISR Number: 3729190-0Report Type:Expedited (15-DaCompany Report #A111271 Age: Gender:Unknown I/FU:I Outcome Dose Duration Required ORAL Intervention to ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Cardiovascular Disorder Foreign Lithium Carbonate PS Pfizer Inc ORAL Literature Ssri Unspecified SS ORAL Health Professional Date:05/25/01ISR Number: 3729191-2Report Type:Expedited (15-DaCompany Report #A111272 Age: Gender:Unknown I/FU:I Outcome Dose Duration Required ORAL Intervention to ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Cardiovascular Disorder Foreign Lithium Carbonate PS Pfizer Inc ORAL Literature Ssri Unspecified SS ORAL Health Professional Date:05/25/01ISR Number: 3729258-9Report Type:Expedited (15-DaCompany Report #A111273 Age: Gender:Unknown I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Required ORAL Intervention to ORAL Prevent Permanent Impairment/Damage Cardiovascular Disorder Foreign Lithium Carbonate PS Literature Ssri Unspecified SS Pfizer Inc ORAL ORAL Health Professional Date:05/25/01ISR Number: 3729259-0Report Type:Expedited (15-DaCompany Report #A111274 Age: Gender:Unknown I/FU:I Outcome Dose Duration Required ORAL Intervention to ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Cardiovascular Disorder Foreign Lithium Carbonate PS Pfizer Inc ORAL Literature Ssri Unspecified SS ORAL Health Professional Date:05/25/01ISR Number: 3729261-9Report Type:Expedited (15-DaCompany Report #A111276 Age: Gender:Unknown I/FU:I Outcome Dose Duration Required ORAL Intervention to ORAL Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 319 10:48 AM PT Report Source Product Role Manufacturer Route Cardiovascular Disorder Foreign Lithium Carbonate PS Pfizer Inc ORAL Literature Ssri Unspecified SS Health Professional ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/01ISR Number: 3729221-8Report Type:Direct Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600MG QAM AND Initial or Prolonged PM PT Company Report # Report Source Asthenia Product Role Lithium Carbonate PS Manufacturer Route Polydipsia Polyuria Tremor Date:05/30/01ISR Number: 3729386-8Report Type:Expedited (15-DaCompany Report #B0109422A Age:29 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Lamotrigine Lithium PS SS Glaxo Wellcome ORAL Route Duration Abortion UNKNOWN Date:05/30/01ISR Number: 3730831-2Report Type:Expedited (15-DaCompany Report #A109699 Age:37 YR Gender:Female I/FU:I Outcome Dose Disability PT Report Source Product Role Manufacturer Coordination Abnormal Wheelchair User Foreign Health Professional Lithium Carbonate Edronax Atenolol Singulair Lastrix Stilnoct Bcom Forte Tradeloan Losec Atarax Atrovent Ventoline Stesolid Panocod Malsine Pulmicort Lactipex PS C C C C C C C C C C C C C C C C Pfizer Inc Duration Date:06/01/01ISR Number: 3731280-3Report Type:Direct Age:12 YR Gender:Male I/FU:I Outcome Dose Other PT Company Report # Report Source Product Role Manufacturer Route Lithium PS Varries/Month To Month ORAL Duration Eye Movement Disorder Tremor 250MG/AM/PM/O RAL Risperdal SS ORAL 1MG/ 2 TIMES/ORAL Date:06/04/01ISR Number: 3733242-9Report Type:Expedited (15-DaCompany Report #B0109422A Age:29 YR Gender:Female I/FU:I Outcome Dose Duration Required ORAL Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 320 10:48 AM PT Report Source Product Role Manufacturer Route Abortion Foreign Lamictal PS Glaxo Wellcome Inc ORAL Lithium Salt (Formulation Unknown) (Lithium Salt) SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/01ISR Number: 3733259-4Report Type:Expedited (15-DaCompany Report #A040222 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 50.00 MG PT Report Source Product Role Manufacturer Route Arrhythmia Foreign Health Zoloft PS Pfizer Pharmaceuticals Inc ORAL Route Professional TOTAL; DAILY; ORAL Lithium Date:06/04/01ISR Number: 3733639-7Report Type:Periodic Age:37 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 40.00 MG SS Company Report #A109062 PT Report Source Product Role Manufacturer Drug Interaction Movement Disorder Health Professional Geodon PS Pfizer Central Research Sedation Company Lithium Carbonate SS Lithium C TOTAL BID Representative 900.00 MG TOTAL Date:06/04/01ISR Number: 3733640-3Report Type:Periodic Age:15 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 40.00 MG Required TOTAL BID Intervention to 1500.00 MG Company Report #A109963 PT Report Source Product Role Manufacturer Grand Mal Convulsion Sedation Health Professional Geodon PS Pfizer Central Research Lithium Carbonate SS Route Prevent Permanent TOTAL BID Impairment/Damage Clozaril Date:06/04/01ISR Number: 3733643-9Report Type:Periodic Age:19 YR Gender:Male I/FU:I Outcome Dose Other C Company Report #A105389 PT Report Source Product Role Manufacturer Route Agitation Drug Ineffective Consumer Health Geodon PS Pfizer Central Research ORAL Insomnia Professional Duration 40.00 MG TOTAL DAILY Mania ORAL Nausea Lithium Carbonate SS Clonazepam C ORAL 4500.00 MG Nervousness TOTAL/ TID Psychotic Disorder ORAL Vomiting Date:06/04/01ISR Number: 3733668-3Report Type:Periodic Age:23 YR Gender:Female I/FU:I Outcome Dose Other Company Report #A109347 PT Report Source Product Role Manufacturer Acne Dyspnoea Health Professional Geodon PS Pfizer Central Research Lithium Carbonate Seroquel Restoril Klonopin Topamax Wellbutrin Sr SS C C C C C Duration 40.00 MG Epistaxis TOTAL:BID Hallucination Sedation Tachycardia 22-Aug-2005 Page: 321 10:48 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Colace Antibiotic Date:06/04/01ISR Number: 3733771-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other 900.00 MG C C Company Report #A036785 PT Report Source Product Role Manufacturer Route Neurosis Consumer Lithium Carbonate PS Pfizer Inc ORAL Zoloft SS Duration Paraesthesia TOTAL; TID: Unevaluable Event ORAL ORAL 150.00 MG TOTAL: TID: ORAL Date:06/04/01ISR Number: 3733772-XReport Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #A100681 PT Report Source Product Role Manufacturer Dizziness Thinking Abnormal Consumer Lithium Carbonate Gabapentin Divalproex PS SS SS Pfizer Inc Route Duration Date:06/05/01ISR Number: 3735326-8Report Type:Expedited (15-DaCompany Report #A109962 Age:37 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 40.00 MG TOTAL:BID PT Report Source Product Role Manufacturer Monoparesis Sedation Health Professional Geodon PS Pfizer Central Research Route Lithium Carbonate SS Naltrexone C 900.00 MG TOTAL:DAILY Date:06/06/01ISR Number: 3735495-XReport Type:Expedited (15-DaCompany Report #2001013043-1 Age:29 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Eskalith PS Smithkline Beecham Pharmaceuticals Lamotrigine C Route Duration Abortion Acne Complications Of Maternal Exposure To Therapeutic Drugs Pregnancy Date:06/06/01ISR Number: 3735707-2Report Type:Expedited (15-DaCompany Report #LBID00201002549 Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG DAILY PT Report Source Product Role Manufacturer Route Depression Fatigue Literature Health Lithobid PS Solvay Pharmaceuticals ORAL Hallucination, Auditory Professional PO Sleep Disorder Suicidal Ideation Fluoxetine (Fluoxetine) SS ORAL Imipramine (Imipramine) SS ORAL 40 MG DAILY PO 50 MG DAILY 22-Aug-2005 Page: 322 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO, 100 MG DAILY PO Thioridazine (Thioridazine) SS ORAL 75 MG DAILY PO, 150 MG DAILY PO Date:06/07/01ISR Number: 3735563-2Report Type:Direct Age:49 YR Gender:Male I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Coordination Abnormal Diabetes Insipidus Drug Level Above Therapeutic Lethargy Product Role Lithium PS Manufacturer Route Date:06/08/01ISR Number: 3737126-1Report Type:Expedited (15-DaCompany Report #2000027543-1 Age:34 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Bradycardia Complications Of Maternal Health Professional Eskalith Cr PS Smithkline Beecham Pharmaceuticals ORAL Duration 450 Exposure To Therapeutic MILLIGRAMS Drugs ORAL 238 DAY Neonatal Disorder Oxygen Saturation Decreased Pregnancy Premature Rupture Of Membranes Skin Discolouration Weight Increased Date:06/11/01ISR Number: 3737116-9Report Type:Periodic Age:30 YR Gender:Male I/FU:I Outcome Dose Company Report #2001-01-0940 PT Report Source Product Role Manufacturer Route Infertility Consumer Other Claritin (Loratadine) PS Schering Corp Sub Schering Plough Corp ORAL Duration 10 MG QD ORAL Synthroid SS ORAL Eskalith SS ORAL Nortriptyline SS ORAL 75 MCG QD ORAL 675 MG QD ORAL 150 MG QD ORAL Date:06/11/01ISR Number: 3737209-6Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #2000-08-2046 PT Report Source Product Role Manufacturer Route Drug Interaction Sexual Dysfunction Consumer Claritin PS Schering Corp Sub Schering Plough Corp ORAL Duration UNKNOWN ORAL Risperdal Dilantin SS SS Lithium SS 600 MG UNKNOWN 1200 MG 22-Aug-2005 Page: 323 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report UNKNOWN Date:06/11/01ISR Number: 3738146-3Report Type:Expedited (15-DaCompany Report #2001013629-1 Age:32 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Grand Mal Convulsion White Blood Cell Count Increased Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals Clozapine Navane (Tiotixene) SS C Route Date:06/12/01ISR Number: 3738482-0Report Type:Expedited (15-DaCompany Report #A109961 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Akathisia Blood Creatine Phosphokinase Increased Health Professional Geodon PS Pfizer Central Research Lithium SS Seroquel (Quetiapine) SS Hypomania Propranolol SS Muscle Rigidity Muscle Spasms Neuroleptic Malignant Syndrome Psychomotor Hyperactivity Pyrexia Restlessness Sleep Talking Tongue Disorder Urinary Incontinence Paxil (Paroxetine) Nortriptyline C C 1200.00 MG Coordination Abnormal TOTAL: Dystonia Extrapyramidal Disorder 200.00 MG Hyperhidrosis TOTAL 60.00 MG Route Date:06/13/01ISR Number: 3738239-0Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200 MG/DAY Initial or Prolonged IN DIVIDED PT Company Report # Report Source Confusional State Product Role Lithium PS Manufacturer Route Route Drug Level Above Therapeutic DOESES Feeling Jittery Date:06/14/01ISR Number: 3740037-9Report Type:Expedited (15-DaCompany Report #A109699 Age:37 YR Gender:Female I/FU:F Outcome Dose Disability 22-Aug-2005 Page: 324 PT Report Source Product Role Manufacturer Condition Aggravated Coordination Abnormal Foreign Health Professional Lithium Carbonate Edronax Atenolol Singulair Lastrix Stilnoct Bcom Forte Tradeloan Losec Atarax Atrovent PS C C C C C C C C C C Pfizer Inc Duration 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ventoline Stesolid Panocod Malsine Pulmicort Lactipex C C C C C C Date:06/14/01ISR Number: 3740106-3Report Type:Expedited (15-DaCompany Report #A112898 Age:38 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200.00 MG Required TOTAL:DAILY:O Intervention to RAL Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Bradycardia Cholelithiasis Foreign Consumer Pfi-Lith PS Pfipharmecs Div Pfizer Inc ORAL Diarrhoea Drug Level Above Therapeutic Fatigue Heart Rate Increased Malaise Mood Swings Pleural Effusion Thyroid Function Test Abnormal Unspecified Medication Date:06/18/01ISR Number: 3741640-2Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Other C Company Report #LBID00200003144 PT Report Source Product Role Manufacturer Route Diarrhoea Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration DAILY PO Company Representative Date:06/18/01ISR Number: 3741641-4Report Type:Periodic Age:38 YR Gender:Female I/FU:I Company Report #LBID00200005241 Outcome Dose Other PT Report Source Product Role Manufacturer Route Alopecia Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 600 MG QD PO Eskalith (Lithium Carbonate) Date:06/18/01ISR Number: 3741643-8Report Type:Periodic Age:61 YR Gender:Female I/FU:I Outcome Dose Other C Company Report #LBID00200005242 PT Report Source Product Role Manufacturer Route Sedation Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY PO Neurontin (Gabapentin) Roxicet Zyprexa (Olanzapine) 22-Aug-2005 Page: 325 10:48 AM C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/01ISR Number: 3741644-XReport Type:Periodic Age:34 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200005258 PT Report Source Product Role Manufacturer Route Bradycardia Hypotension Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 1600 MG DAILY Weight Decreased PO Date:06/18/01ISR Number: 3741647-5Report Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200005294 PT Report Source Product Role Manufacturer Route Alopecia Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG QD PO Eskalith (Lithium Carbonate) SS ORAL 450 MG QD PO Synthroid (Levothyroxine Sodium) Wellbutrin (Amfebutamone Hydrochloride) Benadryl (Diphenhydramine Hydrochloride) Prevacid (Lansoprazole) Neurontin (Gabapentin) Date:06/18/01ISR Number: 3741649-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other C C C C C Company Report #LBID00200005465 PT Report Source Product Role Manufacturer Acne Health Lithobid PS Solvay Duration Route Professional Pharmaceuticals ORAL DAILY PO Date:06/18/01ISR Number: 3741650-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200005483 PT Report Source Product Role Manufacturer Route Acne Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration DAILY PO Company Representative Date:06/18/01ISR Number: 3741651-7Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200005490 PT Report Source Product Role Manufacturer Route Dry Mouth Thirst Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG QD PO Zoloft (Sertraline Hydrochloride) DAILY PO 22-Aug-2005 Page: 326 10:48 AM SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/01ISR Number: 3741653-0Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other PT Company Report #LBID00200005502 Report Source Product Role Manufacturer Route Lithobid PS Solvay Pharmaceuticals ORAL Duration Anorexia Dry Mouth 300 MG QD PO Risperdal (Risperidone) Date:06/18/01ISR Number: 3741654-2Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other C Company Report #LBID00200005516 PT Report Source Product Role Manufacturer Route Asthenia Nausea Consumer Lithobid PS Solvay Pharmaceuticals ORAL Route Duration DAILY PO Antidepressant Date:06/18/01ISR Number: 3742189-3Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other C Company Report #LBID00200005519 PT Report Source Product Role Manufacturer Drug Effect Decreased Health Professional Lithobid PS Solvay Pharmaceuticals Company Representative Prempro C Duration SEE IMAGE Date:06/18/01ISR Number: 3742192-3Report Type:Periodic Age:30 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200005787 PT Report Source Product Role Manufacturer Route Alopecia Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG QD PO Haldol (Haloperidol) C Wellbutrin (Amfebutamone Hydrochloride) Zyprexa (Olanzapine) Vistaril (Hydroxyzine Embonate) Date:06/18/01ISR Number: 3742195-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other C C C Company Report #LBID00200006151 PT Report Source Product Role Manufacturer Route Alopecia Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration DAILY , PO Date:06/18/01ISR Number: 3742197-2Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Acne Alopecia Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration DAILY PO 22-Aug-2005 Page: 327 Company Report #LBID00200006157 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/01ISR Number: 3742199-6Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200006394 PT Report Source Product Role Manufacturer Route Alopecia Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG TID PO Meridia (Sibutranmine Hydrochloride) SS Depakote (Valproate Semisodium) Seroquel (Seroquel) C C ORAL DAILY PO Date:06/18/01ISR Number: 3742201-1Report Type:Periodic Age:78 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200006732 PT Report Source Product Role Manufacturer Route Abdominal Pain Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG DAILY PO Nadolol (Nadolol) Date:06/18/01ISR Number: 3742203-5Report Type:Periodic Age:49 YR Gender:Male I/FU:I Outcome Dose Other C Company Report #LBID00200006762 PT Report Source Product Role Manufacturer Route Diarrhoea Dizziness Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration SEE IMAGE Date:06/18/01ISR Number: 3742205-9Report Type:Periodic Age: Gender:Female I/FU:I Company Report #LBID00201000033 Outcome Dose Other PT Report Source Product Role Manufacturer Route Tremor Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG PO Date:06/18/01ISR Number: 3742206-0Report Type:Periodic Age:27 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00201000196 PT Report Source Product Role Manufacturer Route Asthenia Diarrhoea Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 1800 MG DAILY PO Depakote (Valproate Semisodium) SS Seroquel (Seroquel) C ORAL 1000MG QD PO Date:06/18/01ISR Number: 3742207-2Report Type:Periodic Age:54 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00201000271 PT Report Source Product Role Manufacturer Route Depression Drug Ineffective Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 600 MG DAILY PO Xanax (Alprazolam) 22-Aug-2005 Page: 328 10:48 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/01ISR Number: 3742209-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00201000286 PT Report Source Product Role Manufacturer Route Tremor Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration PO Luvox (Fluvoxamine Maleate) SS Buspar (Buspirone Hydrochloride) C ORAL PO Date:06/18/01ISR Number: 3742222-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00201000500 PT Report Source Product Role Manufacturer Drug Level Above Therapeutic Foreign Literature Lithobid PS Solvay Pharmaceuticals Tremor Health Professional Route Duration SEE IMAGE Date:06/18/01ISR Number: 3742224-2Report Type:Periodic Age:51 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00201000538 PT Report Source Product Role Manufacturer Route Alopecia Amblyopia Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 400 MG BID PO Diarrhoea Date:06/18/01ISR Number: 3742228-XReport Type:Periodic Age: Gender: I/FU:I Glucotrol Xl (Glipizide) Glucophage (Metformin Hydrochloride) Company Report #LBID00201000586 C C Outcome Dose Other PT Report Source Product Role Manufacturer Route Mania Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration DAILY PO Date:06/18/01ISR Number: 3742230-8Report Type:Periodic Age:11 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00201000645 PT Report Source Product Role Manufacturer Route Alopecia Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 1200 MG DAILY PO Bisperdal (Risperidone) Prozac (Fluoxetine Hydrochloride) Concerta (Methylphenidate-Slo w Release) 22-Aug-2005 Page: 329 10:48 AM C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/01ISR Number: 3742232-1Report Type:Periodic Age:21 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00201001255 PT Report Source Product Role Manufacturer Route Depression Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration PO Luvox (Fluvoxamine Maleate) SS ORAL Risperdal (Risperidone) SS ORAL PO, PO PO Date:06/18/01ISR Number: 3742234-5Report Type:Periodic Age:16 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00201001469 PT Report Source Product Role Manufacturer Route Tremor Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration PO, PO Company Representative Date:06/18/01ISR Number: 3742239-4Report Type:Periodic Age:49 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00201001658 PT Report Source Product Role Manufacturer Route Alopecia Consumer Lithobid PS Solvay Pharmaceuticals ORAL Route Duration 300 MG BID PO Date:06/18/01ISR Number: 3742257-6Report Type:Periodic Age:37 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00201001670 PT Report Source Product Role Manufacturer Alopecia Consumer Lithobid PS Solvay Duration Hair Disorder Pharmaceuticals ORAL 1200 MG DAILY PO Depakote (Valproate Semisodium) Date:06/18/01ISR Number: 3742258-8Report Type:Periodic Age:30 YR Gender:Male I/FU:I Outcome Dose Other C Company Report #LBID00200002853 PT Report Source Product Role Manufacturer Route Hormone Level Abnormal Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 2400 MG DAILY Company PO Representative Date:06/18/01ISR Number: 3742271-0Report Type:Periodic Age:20 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Alopecia Mania Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 600 MG DAILY PO, 1200 MG DAILY PO 22-Aug-2005 Page: 330 Company Report #LBID00200005347 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/01ISR Number: 3742274-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200005485 PT Report Source Product Role Manufacturer Route Paraesthesia Oral Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG DAILY PO Risperdal (Risperidone) SS Synthroid (Levothyroxine Sodium) C ORAL 0.5 MG DAILY PO, 0.25 MG DAILY PO Date:06/18/01ISR Number: 3742277-1Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200005517 PT Report Source Product Role Manufacturer Route Drug Level Below Therapeutic Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Company Representative Vitamin B (Vitamin B) Duration PO DAILY Date:06/18/01ISR Number: 3742283-7Report Type:Periodic Age:51 YR Gender:Female I/FU:I Outcome Dose Other 900MG DAILY PO C Company Report #LBID00200005571 PT Report Source Product Role Manufacturer Route Visual Field Defect Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration Date:06/18/01ISR Number: 3742285-0Report Type:Periodic Age:17 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200005600 PT Report Source Product Role Manufacturer Route Hormone Level Abnormal Weight Increased Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration DAILY PO Date:06/18/01ISR Number: 3742286-2Report Type:Periodic Age:55 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200005690 PT Report Source Product Role Manufacturer Route Amnesia Constipation Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY Headache PO Hypokinesia Pollakiuria Visual Disturbance 22-Aug-2005 Page: 331 10:48 AM Synthroid (Levothyroxine Sodium) Premarin (Estrogens Conjugated Baycol (Cerivastatin Sodium) Klonopin (Clonazepam) C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/01ISR Number: 3742288-6Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00200005737 PT Report Source Product Role Manufacturer Route Drug Ineffective Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration DAILY PO Company Representative Date:06/18/01ISR Number: 3742291-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200005826 PT Report Source Product Role Manufacturer Route Diarrhoea Haemorrhagic Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY PO Celebrex (Celecoxib) SS Vasotec (Enalapril Maleate) C ORAL DAILY PO Date:06/18/01ISR Number: 3742294-1Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200006123 PT Report Source Product Role Manufacturer Route Hyperhidrosis Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration DAILY PO Company Representative Date:06/18/01ISR Number: 3742295-3Report Type:Periodic Age:57 YR Gender:Female I/FU:I Company Report #LBID00200006190 Outcome Dose Other PT Report Source Product Role Manufacturer Route Asthenia Drug Level Below Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG BID PO Therapeutic Skin Disorder Weight Increased Synthroid (Levothyroxine Sodium) Date:06/18/01ISR Number: 3742339-9Report Type:Periodic Age:32 YR Gender:Male I/FU:I Outcome Dose Other 1500 C Company Report #LBID00200006195 PT Report Source Product Role Manufacturer Route Pollakiuria Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration MG DAILY PO Topamax (Topiramate) Risperdal (Risperidone) Loxapine (Loxapine) Date:06/18/01ISR Number: 3742341-7Report Type:Periodic Age:23 YR Gender:Female I/FU:I Outcome Other 22-Aug-2005 Page: 332 PT Oedema Peripheral 10:48 AM Company Report #LBID00200006354 Report Source Health Professional C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Dose Product Role Manufacturer Route Lithobid PS Solvay Pharmaceuticals ORAL Duration DAILY PO Date:06/18/01ISR Number: 3742343-0Report Type:Periodic Age:65 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200006540 PT Report Source Product Role Manufacturer Route Urine Abnormality Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 30 MG BID PO Lipitor (Atorvastatin) Prevacid (Lansoprazole) Synthroid (Levothyroxine Sodium) Claritin (Loratadine) Vioxx (Rofecoxib) Date:06/18/01ISR Number: 3742345-4Report Type:Periodic Age:7 YR Gender:Male I/FU:I Outcome Dose Other C C C C C Company Report #LBID00200006555 PT Report Source Product Role Manufacturer Route Pain Tremor Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG BID PO Vomiting Luvox (Fluvoxamine Maleate) SS 50 MG BID PO Zyprexa (Olanzapine) Risperidal (Risperidone) C C ORAL Date:06/18/01ISR Number: 3742348-XReport Type:Periodic Age:28 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200006631 PT Report Source Product Role Manufacturer Route Dermatitis Diarrhoea Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 300MG BID PO, Eczema 300 MG BID PO Leukocytosis Vomiting 22-Aug-2005 Page: 333 10:48 AM Benadryl (Diphenhyrdramine Hydrochloride) Tagamet (Cimetidine) Zyrtec (Cetirizine Hydrochloride) Xanax (Alprazolam) Depakote (Valproate Semisodium) Proventil Tablet (Salbutamol Sulfate) Serevent (Salmeterol Xinafoate) Singulair (Montelukast Sodium) C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/01ISR Number: 3742350-8Report Type:Periodic Age:23 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00200006657 PT Report Source Product Role Manufacturer Route Drug Level Above Therapeutic Literature Health Lithobid PS Solvay Pharmaceuticals ORAL Professional Suldox (Suldinac) Duration 1500 MG PO C ORAL 150 MG BID PO Divalproex Sodium (Divalproex Sodium) Olanzapine (Olanzapine) Date:06/18/01ISR Number: 3742353-3Report Type:Periodic Age:27 YR Gender:Female I/FU:I Outcome Dose Other C C Company Report #LBID00200006661 PT Report Source Product Role Manufacturer Route Drug Interaction Drug Level Above Literature Health Lithobid PS Solvay Pharmaceuticals ORAL Therapeutic Professional Suldox (Suldinac) Duration 900 MG BID PO SS ORAL 150 MG BID PO Pain Nefazodone (Nefazodone Hydrochloride) Fluphenazine Deconate (Fluphenazine) Date:06/18/01ISR Number: 3742354-5Report Type:Periodic Age:15 YR Gender:Male I/FU:I Outcome Dose Other C C Company Report #LBID00200006696 PT Report Source Product Role Manufacturer Route Urinary Incontinence Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration DAILY PO Company Representative Date:06/18/01ISR Number: 3742356-9Report Type:Periodic Age:27 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00201000023 PT Report Source Product Role Manufacturer Route Alopecia Insomnia Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 1200 MG DAILY Pollakiuria PO Tremor Urinary Retention Date:06/18/01ISR Number: 3742358-2Report Type:Periodic Age:33 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Dermatitis Bullous Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration SEE IMAGE 22-Aug-2005 Page: 334 Company Report #LBID00201000031 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/01ISR Number: 3742492-7Report Type:Periodic Age:56 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00201000153 PT Report Source Product Role Manufacturer Route Gout Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY PO Date:06/18/01ISR Number: 3742493-9Report Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00201000346 PT Report Source Product Role Manufacturer Route Anorexia Hallucination Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG BID PO Hyperhidrosis Insomnia Meridia (Sibutramine Hydrochloride) SS ORAL Unk () SS ORAL 10 MG DAILY Weight Increased PO DAILY PO Zoloft (Sertraline Hydrochloride) Synthroid (Levothyroxine Sodium) (Lorazepam) Estrace (Estradiol) (Progesterone) Date:06/18/01ISR Number: 3742494-0Report Type:Periodic Age:13 YR Gender:Male I/FU:I Outcome Dose Other C C C C C Company Report #LBID00201000348 PT Report Source Product Role Manufacturer Route Asthenia Eye Disorder Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 1200 MG DAILY Personality Disorder PO Ritalin (Methylphenidate Hydrochloride) Clonidine (Clonidine) Date:06/18/01ISR Number: 3742495-2Report Type:Periodic Age:55 YR Gender:Female I/FU:I Outcome Dose Other C C Company Report #LBID00201000428 PT Report Source Product Role Manufacturer Route Amblyopia Arthralgia Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG QD PO Drug Interaction Muscle Spasms Calcium W/Magnesium () SS ORAL DAILY PO Tendon Disorder Tongue Disorder Date:06/18/01ISR Number: 3742496-4Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Laboratory Test Abnormal Vasodilatation Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY PO 22-Aug-2005 Page: 335 Company Report #LBID00201000448 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levoxyl (Levothyroxine Sodium) Date:06/18/01ISR Number: 3742497-6Report Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose Other C Company Report #LBID00201000894 PT Report Source Product Role Manufacturer Route Conjunctivitis Dry Mouth Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG TID PO Keratoconjunctivitis Sicca Tolvon (Mianserin Hydrochloride) Date:06/18/01ISR Number: 3742498-8Report Type:Periodic Age:22 YR Gender:Male I/FU:I Outcome Dose Other C Company Report #LBID00201001077 PT Report Source Product Role Manufacturer Route Thrombocytopenia Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY PO Clozapine (Clozapine) SS 25 MG DAILY PO, 300 MG DAILY PO Dilantin (Phenytoin Sodium) (Propranolol) Aricept (Donepezil Hydrochloride) Date:06/18/01ISR Number: 3742499-XReport Type:Periodic Age:56 YR Gender:Female I/FU:I Company Report #LBID00201001484 C C C ORAL Outcome Dose Other PT Report Source Product Role Manufacturer Route Glossitis Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY PO Levothroid (Levothyroxine Sodium) Cyclobenzaprine (Cyclobenzaprine) Arthritis Medication Date:06/18/01ISR Number: 3742500-3Report Type:Periodic Age:41 YR Gender:Male I/FU:I Outcome Dose Other 300 C C C Company Report #LBID00201001665 PT Report Source Product Role Manufacturer Route Emotional Disorder Insomnia Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration MG WD PO Nortriptyline (Nortriptyline) Doxepin (Doxepin) Klonopin (Clonazepam) 22-Aug-2005 Page: 336 10:48 AM C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/01ISR Number: 3742501-5Report Type:Periodic Age:54 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00201001823 PT Report Source Product Role Manufacturer Route Anorgasmia Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG QD PO Risperdal (Risperidone) SS ORAL 1 MG DAILY PO Estrace (Estradiol) Levoxyl (Levothyroxine Sodium) Atenolol ( Atenolol) Furosemide (Furosemide) Detrol (Tolterodine L-Tartrate) Date:06/18/01ISR Number: 3742502-7Report Type:Periodic Age:6 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY PO C C C C C Company Report #LBID00200003054 PT Report Source Product Role Manufacturer Route Speech Disorder Tremor Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Company Representative Date:06/18/01ISR Number: 3742503-9Report Type:Periodic Age:65 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE 2 YR Company Report #LBID00200006013 PT Report Source Product Role Manufacturer Route Sinus Bradycardia Foreign Literature Lithobid PS Solvay Pharmaceuticals ORAL Health Professional Other Sotalol (Sotalol) Atenolol (Atenolol) C C Date:06/18/01ISR Number: 3742504-0Report Type:Periodic Age:61 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY PO Company Report #LBID00201000651 PT Report Source Product Role Manufacturer Route Bradycardia Dizziness Consumer Lithobid PS Solvay Pharmaceuticals ORAL Overdose Paxil (Paroxetine Hydrochloride) Risperdal (Risperidone) Date:06/18/01ISR Number: 3742505-2Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY PO 22-Aug-2005 Page: 337 10:48 AM C C Company Report #LBID00201000991 PT Report Source Product Role Manufacturer Route Overdose Health Professional Lithobid PS Solvay Pharmaceuticals ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/01ISR Number: 3742507-6Report Type:Periodic Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged DAILY PO Company Report #LBID00200000725 PT Report Source Product Role Manufacturer Route Accidental Overdose Drug Level Above Consumer Lithobid PS Solvay Pharmaceuticals ORAL Therapeutic Date:06/18/01ISR Number: 3742508-8Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200002723 PT Report Source Product Role Manufacturer Route Drug Level Below Therapeutic Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 1800 MG DAILY Company PO Representative Date:06/18/01ISR Number: 3742510-6Report Type:Periodic Age:57 YR Gender:Female I/FU:I Outcome Dose Other Company Report #LBID00200002757 PT Report Source Product Role Manufacturer Route Diarrhoea Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG QD PO Date:06/18/01ISR Number: 3742512-XReport Type:Periodic Age:35 YR Gender:Female I/FU:I Outcome Dose Other 300 MG DAILY PO Company Report #LBID00200002784 PT Report Source Product Role Manufacturer Route Tremor Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration Neurontin (Gabapentin) Parmate (Tranylcypromide) Date:06/18/01ISR Number: 3742513-1Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other C C Company Report #LBID00200002908 PT Report Source Product Role Manufacturer Route Drug Level Below Therapeutic Foreign Health Lithobid PS Solvay Pharmaceuticals ORAL Duration 1800 MG DAILY Professional PO Company Representative Other Date:06/18/01ISR Number: 3742515-5Report Type:Periodic Age:21 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00200003100 PT Report Source Product Role Manufacturer Route Tremor Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 300 MG DAILY PO Paxil ([Aroxetine Hydrochloride) 22-Aug-2005 Page: 338 10:48 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/01ISR Number: 3743548-5Report Type:Periodic Age:37 YR Gender:Male I/FU:I Outcome Dose Other Company Report #LBID00201001851 PT Report Source Product Role Manufacturer Route Constipation Dyspepsia Consumer Lithobid PS Solvay Pharmaceuticals ORAL Duration 1200 MG DAILY Sedation PO Thyroid Hormones (Thyroid) St John'S Wort (St. John'S Wort) Date:06/18/01ISR Number: 3743549-7Report Type:Periodic Age:13 YR Gender:Male I/FU:I Outcome Dose Other C C Company Report #LBID00201001922 PT Report Source Product Role Manufacturer Route Accident Impaired Healing Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY PO Concerta Date:06/18/01ISR Number: 3743550-3Report Type:Periodic Age:30 YR Gender:Female I/FU:I Outcome Dose Other C Company Report #LBID00201001555 PT Report Source Product Role Manufacturer Route Coordination Abnormal Paranoia Health Professional Lithobid PS Solvay Pharmaceuticals ORAL Duration 900 MG DAILY Speech Disorder PO Seroquel (Seroquel) 600 MG DAILY PO Wellbutrin - Slow Release SS ORAL (Amfebutamone Hydrochloride) SS ORAL Klonopin (Clonazepam) SS ORAL Celebrex (Celecoxib) SS ORAL 150 MG DAILY PO 2 MG DAILY PO UNK DAILY PO Date:06/19/01ISR Number: 3742477-0Report Type:Expedited (15-DaCompany Report #A113136 Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Required Intervention to 120.00 MG Prevent Permanent TOTAL;BID;ORA Impairment/Damage L PT Report Source Product Role Manufacturer Route Blood Creatinine Increased Consumer Geodon PS Pfizer Central Research ORAL Blood Urea Increased Drug Level Above Therapeutic Lithium SS Sinemet Premarin Pepcid Flovent Levothyroxine Primidone Triazolam C C C C C C C 180.00 MG Muscle Rigidity TOTAL;TID;ORA Tremor L 22-Aug-2005 Page: 339 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/01ISR Number: 3747221-9Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Other PT Company Report # Report Source Product Role Manufacturer Route Lithium Carb 300 Mg Roxa PS Roxa ORAL Remeron 15 Mg Org SS Org ORAL Duration Depression Suicidal Ideation 900 MG Tremor EVERDAY ORAL 15 MG EVERYDAY ORAL Date:06/26/01ISR Number: 3748084-8Report Type:Expedited (15-DaCompany Report #A110238 Age:41 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening Hospitalization BID PO Initial or Prolonged DAILY Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Neuroleptic Malignant Syndrome Health Professional Geodon PS Pfizer Central Research ORAL Psychotic Disorder Company Clozapine SS Urinary Tract Infection Representative Lithium Lipitor Depakote Er Zyprexa SS C C C Date:06/26/01ISR Number: 3750582-8Report Type:Expedited (15-DaCompany Report #2001015107-1 Age:33 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 450 Initial or Prolonged MILLIGRAMS Other DAILY ORAL 1 DAY PT Report Source Product Role Manufacturer Route Drug Level Above Therapeutic Health Professional Eskalith Cr PS Smithkline Beecham Pharmaceuticals ORAL Haemodialysis Overdose Renal Failure Acute Date:06/27/01ISR Number: 3748388-9Report Type:Direct Age:56 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 600 MG BID Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Product Role Coordination Abnormal Lithium 300mg PS Dehydration Drooling Drug Toxicity Parkinsonian Gait Renal Failure Acute Speech Disorder Tremor Hctz Lisinopril Arthrotec Fluticasone Asa Verapamil Sr Thioridazine C C C C C C I Manufacturer Route Date:06/27/01ISR Number: 3749453-2Report Type:Expedited (15-DaCompany Report #LBID00201002834 Age:43 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY PO PT Report Source Product Role Manufacturer Route Back Pain Diabetes Mellitus Literature Health Lithobid PS Solvay Pharmaceuticals ORAL Non-Insulin-Dependent Drug Effect Decreased Professional Tegretol (Carbamazepine) SS ORAL Valproate (Valproate Sodium) SS ORAL Clozapine (Clozapine) C DAILY PO, 1 G Hypertension DAILY PO Obesity Paraesthesia DAILY PO 22-Aug-2005 Page: 340 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/01ISR Number: 3770379-2Report Type:Periodic Age: Gender: I/FU:I Outcome Dose Company Report #2001010864-1 PT Report Source Product Role Drug Interaction Health Avandia PS Drug Toxicity Professional Lithium Hydrochlorothiazide SS SS Manufacturer Route Duration ORAL ORAL Date:06/28/01ISR Number: 3748664-XReport Type:Expedited (15-DaCompany Report #262790 Age:35 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged THE LONG TERM PT Report Source Product Role Manufacturer Drug Interaction Schizophrenia Health Professional Xenical Zyprexa PS I Roche Teralithe I Route TREATMENT OF SCHIZOPHRENIA HAS BEEN LOWERED BY THE LONG TERM TREATMENT OF SCHIZOPHRENIA HAS BEEN LOWERED BY Date:06/29/01ISR Number: 3750293-9Report Type:Expedited (15-DaCompany Report #17812-136 Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization - PT Report Source Product Role Manufacturer Hallucination Consumer Lithium Carbonate PS Roxane Laboratories Route Initial or Prolonged 600 Imprisonment Inc ORAL Eli Lilly ORAL Road Traffic Accident MG,BID,ORAL 10 YR Zyprexa(Olanzapine)T ablet, 10mg Eli Lilly SS 10MG,QHS,ORAL Trazadone Ativan (Lorazepam) Inderal (Propranolol) C C C Date:07/02/01ISR Number: 3751054-7Report Type:Expedited (15-DaCompany Report #262790 Age:35 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Condition Aggravated Foreign Xenical PS Hlr Technology ORAL Drug Interaction Health Zyprexa (Olanzapine) SS ORAL Medication Error Persecutory Delusion Professional Teralithe (Lithium Carbonate) SS ORAL ORAL Schizophrenia Date:07/03/01ISR Number: 3752520-0Report Type:Periodic Age:62 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Condition Aggravated Gastritis Health Professional Prevacid (Lansoprazole) (30 Milligram, Capsules) PS Tap Pharmaceutical Products Inc ORAL Duration 30 MG, 1 IN 1 D, PER ORAL 22-Aug-2005 Page: 341 Company Report #TAP2001Q00302 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium (Lithium) Date:07/05/01ISR Number: 3752569-8Report Type:Direct Age:66 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 450 MG PO Initial or Prolonged DAILY PT SS Company Report # Report Source Anxiety Product Role Lithium 450 Mg PS Clonidine Lopressor Lipitor Clonazepam Celexa C C C C C Manufacturer Route ORAL Confusional State Decreased Appetite Headache Insomnia Tremor Date:07/05/01ISR Number: 3753625-0Report Type:Expedited (15-DaCompany Report #A115588 Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Required ORAL Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Angina Pectoris Foreign Lithium Carbonate PS Pfizer Inc ORAL Coronary Artery Disease Dyspnoea Electrocardiogram Abnormal Electrocardiogram T Wave Inversion Myocardial Ischaemia Sinus Bradycardia Health Professional Ziprasidone C Route Date:07/05/01ISR Number: 3753660-2Report Type:Expedited (15-DaCompany Report #2001AP03089 Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 16 MG DAILY 8 WK PT Report Source Product Role Manufacturer Agitation Confusional State Foreign Literature Atacand PS Astrazeneca Pharmaceuticals Lp Coordination Abnormal Health Disorientation Drug Interaction Professional Other Lithium SS 900 MG DAILY Date:07/06/01ISR Number: 3754375-7Report Type:Expedited (15-DaCompany Report #A115201 Age:36 YR Gender:Male I/FU:I Outcome Dose Duration Required 1200.00 MG Intervention to TOTAL;DAILY Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Anorgasmia Foreign Lithium Carbonate PS Pfizer Inc Ejaculation Failure Literature Hypomania Orgasm Abnormal Health Professional Route Date:07/09/01ISR Number: 3754671-3Report Type:Expedited (15-DaCompany Report #2001015445-1 Age:16 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL Other 22-Aug-2005 Page: 342 10:48 AM PT Report Source Product Role Manufacturer Route Dialysis Dysarthria Literature Health Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Overdose Sedation Suicide Attempt Professional ... Clonazepam (Klonopin) C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chlopromazine Hydrochloride (Thorazine) C Date:07/11/01ISR Number: 3756472-9Report Type:Expedited (15-DaCompany Report #200111619BWH Age:60 YR Gender:Female I/FU:F Outcome Dose Duration Other 60 MG QD ORAL PT Report Source Product Role Manufacturer Route Condition Aggravated Consumer Adalat Cc PS Bayer Corp ORAL Coordination Abnormal Other Adalat Cc SS ORAL Lithobid (Lithium Carbonate) SS ORAL Depakote Ticlid Temazepam Atenolol Glyburide Tamoxifen C C C C C C 30 MG QD ORAL Difficulty In Walking Drug Interaction 600 MG DAILY Drug Level Above ORAL Therapeutic Date:07/11/01ISR Number: 3756561-9Report Type:Expedited (15-DaCompany Report #2001015737-1 Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 20 MILLIGRAMS PT Report Source Product Role Manufacturer Route Blood Pressure Decreased Cognitive Disorder Consumer Paxil PS Smithkline Beecham Pharmaceuticals ORAL Convulsion 1.0 DAILY Feeling Abnormal ORAL Headache Nausea Oral Discomfort Oral Intake Reduced Tremor Lithium SS Date:07/11/01ISR Number: 3756729-1Report Type:Expedited (15-DaCompany Report #FLUV00301003007 Age:65 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 100 MG DAILY PT Report Source Product Role Manufacturer Route Anxiety Cerebral Atrophy Foreign Literature Luvox PS Solvay Pharmaceuticals ORAL Communication Disorder Other PO, 150 MG Decreased Appetite DAILY PO, Depression DAILY PO Insomnia Lithium (Lithium) SS 400 MG DAILY, Irritability 200 MG DAILY Lethargy Mental Impairment Nuclear Magnetic Resonance Imaging Abnormal Parkinsonism Suicidal Ideation 22-Aug-2005 Page: 343 10:48 AM Sulpiride (Sulpiride) Imipramine (Imipramine) C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/01ISR Number: 3756812-0Report Type:Expedited (15-DaCompany Report #10902245 Age:26 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other 2.8 GRAM 1/ PT Report Source Product Role Manufacturer Delirium Drug Level Above Therapeutic Foreign Health Professional Serzone PS Bristol Myers Squibb Co Pharmaceutical Research Institute Haemodialysis Company Intentional Misuse Representative Alprazolam SS Respiratory Failure Other Cyproheptadine Cyproheptadine Hcl) SS Lithium (Lithium Salts) SS Route TOTAL 2 GRAM 1 TOTAL Suicide Attempt 2.4 GRAM 1 TOTAL 1 TOTAL Date:07/20/01ISR Number: 3761971-XReport Type:Expedited (15-DaCompany Report #262790 Age:31 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 31 DAY Initial or Prolonged PT Report Source Product Role Manufacturer Drug Interaction Xenical PS Roche Schizophrenia Seresta Risperdal C I Teralithe I THE LONG TERM TREATMENT OF SCHIZOPHRENIA HAS BEEN LOWERED BY THE LONG TERM Route TREATMENT OF SCHIZOPHRENIA HAS BEEN LOWERED BY Date:07/23/01ISR Number: 3762411-7Report Type:Direct Age:13 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 100ML TWICE Initial or Prolonged DAILY ORAL PT Company Report # Report Source Malaise Product Lithium Role 100 Ml Tegratol Date:07/23/01ISR Number: 3775454-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose PS Route ORAL C Company Report #2001053231US PT Report Source Product Role Manufacturer Route Orgasm Abnormal Consumer Detrol La PS Pharmacia And Upjohn Co ORAL Duration ORAL Lithobid (Lithium Carbonate) SS 300 MG QD UNK Estrace Levoxyl (Levothyroxine Sodium) Risperdal Atenolol Lasix 22-Aug-2005 Page: 344 Manufacturer 10:48 AM C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/01ISR Number: 3764232-8Report Type:Expedited (15-DaCompany Report #200111619BWH Age:60 YR Gender:Female I/FU:F Outcome Dose Duration Other 60 MG QD ORAL PT Report Source Product Role Manufacturer Route Condition Aggravated Consumer Adalat Cc PS Bayer Corp ORAL Coordination Abnormal Difficulty In Walking Other Lithobid (Lithium Carbonate) SS ORAL Drug Level Above Adalat Cc SS ORAL Therapeutic Facial Palsy Fall Depakote Ticlid Temazepam Atenolol Glyburide Tamoxifen Cozaar C C C C C C C 600 MG DAILY Drug Interaction ORAL 30 MG QD ORAL Date:07/24/01ISR Number: 3764263-8Report Type:Expedited (15-DaCompany Report #262790 Age:31 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Manufacturer Route Condition Aggravated Foreign Xenical PS Hlr Technology ORAL Drug Interaction Medication Error Health Professional Risperdal(Risperidon e) SS ORAL Teralithe (Lithium Carbonate) SS ORAL Seresta C 1 MG DAILY Persecutory Delusion ORAL Schizophrenia ORAL Date:07/25/01ISR Number: 3764348-6Report Type:Direct Age:69 YR Gender:Male I/FU:I Company Report # Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG BID PT Report Source Drug Level Below Therapeutic Product Role Lithium Carbonate 300mg PS Aspirin Carbamazepine Ibuprofen Lisinopril Simvastatin Terazosin C C C C C C Manufacturer Route ORAL Mania ORAL Date:07/25/01ISR Number: 3765246-4Report Type:Expedited (15-DaCompany Report #LBID00201003129 Age:80 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY PO PT Report Source Product Role Manufacturer Route Delusion Hallucination Literature Health Lithobid PS Solvay Pharmaceuticals ORAL Tremor Professional Date:07/25/01ISR Number: 3765695-4Report Type:Expedited (15-DaCompany Report #264199 Age:35 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged Disability 22-Aug-2005 Page: 345 10:48 AM PT Arthralgia Drug Interaction Psoriasis FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thyroiditis Dose Report Source Product Role Manufacturer Route Foreign Health Lariam PS Hoffmann La Roche Inc ORAL Duration 1 DOSE FORM 1 Professional PER ONE DOSE ORAL Effexor SS ORAL Lexomil SS ORAL Teralithe SS ORAL Seropram SS ORAL Havlane Plaquenil C C 2 DOSE FORM DAILY ORAL 2 PER DAY ORAL 400 MG 3 PER DAY ORAL 2 DOSE FORM DAILY ORAL Date:07/25/01ISR Number: 3765810-2Report Type:Direct Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged TAKE 1 TSP PT Dehydration Diarrhoea Company Report # Report Source Product Role Lithium Citrate 300mg/5ml PS Benztropine Risperidone Fluphenazine C C C Drug Level Above TID PO Therapeutic Tremor Vomiting Manufacturer Route ORAL Date:07/26/01ISR Number: 3765375-5Report Type:Direct Age: Gender: I/FU:I Outcome Dose Other PT Company Report #USP 54201 Report Source Product Role Lithium Carbonate Lithium Carbonate PS SS Manufacturer Route Duration Fall Head Injury Medication Error Date:07/26/01ISR Number: 3766176-4Report Type:Expedited (15-DaCompany Report #A117130 Age:33 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 120.00 MG PT Report Source Product Role Manufacturer Route Amnesia Difficulty In Walking Consumer Geodon PS Pfizer Central Research ORAL Drug Interaction TOTAL: Drug Level Above BIID:ORAL Therapeutic Lithium SS ORAL Zyprexa (Olanzapine) SS ORAL Tegretol (Carbamazepine) SS ORAL 1600.00 MG Hallucination TOTAL: DAILY: ORAL 30.00 MG TOTAL: DAILY:ORAL ORAL Sleeping Medication Blood Pressure Medication 22-Aug-2005 Page: 346 10:48 AM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/01ISR Number: 3766180-6Report Type:Expedited (15-DaCompany Report #A117132 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Coordination Abnormal Drug Interaction Drug Level Above Therapeutic Dysarthria Consumer Geodon PS Pfizer Central Research Lithium SS Route Date:07/26/01ISR Number: 3766560-9Report Type:Expedited (15-DaCompany Report #LEID00201003144 Age:67 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG TID PO PT Report Source Product Role Manufacturer Route Bladder Cancer Hypercalcaemia Literature Health Lithobid PS Solvay Pharmaceuticals ORAL Hyperparathyroidism Primary Laboratory Test Abnormal Nephrogenic Diabetes Insipidus Renal Cell Carcinoma Stage Unspecified Transient Ischaemic Attack Professional Nifedipine (Nifedipine) Fosinopril (Fosinopril) Levothyroxine (Levothyroxine) Route C C C Date:07/30/01ISR Number: 3767686-6Report Type:Expedited (15-DaCompany Report #2001017851-1 Age:53 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Pancreatitis Health Professional Eskalith PS Smithkline Beecham Pharmaceuticals Duration Date:07/30/01ISR Number: 3767699-4Report Type:Expedited (15-DaCompany Report #200111619BWH Age:60 YR Gender:Female I/FU:F Outcome Dose Other 60 MG QD PT Report Source Product Role Manufacturer Route Condition Aggravated Consumer Adalat Cc PS Bayer Corp ORAL Coordination Abnormal Other Difficulty In Walking Adalat Cc SS ORAL Drug Level Above Therapeutic Lithobid (Lithium Carbonate) SS ORAL Depakote Ticlid Temazepam Atenolol Glyburide Tamoxifen Cozaar C C C C C C C Duration ORAL 30 MG QD ORAL 600 MG DAILY Eye Infection ORAL Facial Palsy Fall Date:07/30/01ISR Number: 3767729-XReport Type:Expedited (15-DaCompany Report #01-0052 Age:34 YR Gender:Male I/FU:F Outcome Death Hospitalization Initial or Prolonged 22-Aug-2005 Page: 347 10:48 AM PT Anaphylactic Shock Atelectasis Cardiac Failure FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Disseminated Intravascular Coagulation Dose Report Source Product Role Manufacturer Route Other Ponstel PS First Horizon Pharmaceutical Corp ORAL Duration Duodenal Ulcer Enteritis 250 MG, TID, Haemodialysis PO Hypogammaglobulinaemia Hypoproteinaemia Serenace (Haloperidol) SS Oesophagitis Pleural Effusion Limas (Lithium Carbonate) SS Pneumonia Pulmonary Embolism Pulmonary Mycosis Rash Erythematous Renal Failure Acute Rhabdomyolysis Sepsis Staphylococcal Infection Depas (Etizolam) Artane (Trihexyphenidyl Hydrochloride) Silece (Flunitrazepam) Impromen (Bromperidol) Remark (Betahistine Mesilate) 33MG, TID, PO ORAL 200MG;TID;PO C C C C C Date:07/30/01ISR Number: 3769107-6Report Type:Expedited (15-DaCompany Report #2001017719-1 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Thyroid Gland Cancer Consumer Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Route Duration ORAL Date:07/30/01ISR Number: 3769108-8Report Type:Expedited (15-DaCompany Report #2001016845-1 Age:55 YR Gender:Male I/FU:I Outcome Dose Other 11 YR PT Report Source Product Role Manufacturer Acanthosis Alopecia Literature Health Lithium Smithkline Beecham PS Smithkline Beecham Duration Antibody Test Positive Antinuclear Antibody Positive Atelectasis Biopsy Skin Abnormal Drug Level Below Therapeutic Inflammation Laboratory Test Abnormal Mycosis Fungoides Rash Erythematous Rash Papular Skin Lesion Professional Date:07/31/01ISR Number: 3777716-3Report Type:Periodic Age:30 YR Gender:Female I/FU:I Outcome Dose Haloperidol C Company Report #2001056168US PT Report Source Product Role Manufacturer Route Coordination Abnormal Health Celebrex PS Gd Searle And Co ORAL Paranoia Speech Disorder Professional Lithobid (Lithium Carbonate) SS ORAL Seroquel (Quetiapine) SS ORAL Duration ORAL 900 MG, QD, ORAL 600 MG, QD, 22-Aug-2005 Page: 348 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Klonopin (Clonazepam) SS ORAL Wellbutrin-Slow Release (Amfebutamone Hydrochloride) SS ORAL 2 MG, QD, ORAL 150 MG, QD, ORAL Date:08/01/01ISR Number: 3769304-XReport Type:Expedited (15-DaCompany Report #M2001.0463/LBIDO0201003074 Age:25 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Acne Convulsion Consumer Lonox PS Geneva Pharmaceuticals Inc ORAL Duration DAILY PO Drug Interaction Fall Lithobid (Lithium Carbonate) SS Celexa (Citalopram Hydrobromide) C ORAL 1500 MG DAILY Scar PO Syncope Date:08/02/01ISR Number: 3770162-8Report Type:Expedited (15-DaCompany Report #A109961 Age:45 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 40.00 PT Report Source Product Role Manufacturer Route Ecchymosis Fall Health Professional Geodon PS Pfizer Central Research ORAL Neuroleptic Malignant TOTAL:ORAL Syndrome 1200.00 MG Lithium SS TOTAL Seroquel (Quetiapine) SS Propranolol SS Paxil (Paroxetine) Nortriptyline C C 200.00 MG TOTAL 60.00 MG TOTAL Date:08/02/01ISR Number: 3770300-7Report Type:Expedited (15-DaCompany Report #S01-SWI-01503-01 Age:70 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 30 MG QD PO Initial or Prolonged Disability 1200 MG QD PO PT Report Source Product Role Manufacturer Route Coma Drug Interaction Foreign Health Celexa PS Forest Laboratories Inc ORAL Encephalopathy Professional Other Priadel (Lithium Carbonate) SS ORAL Tolvon(Mianserin Hydrochloride) SS ORAL Entumin(Clotiapine) SS ORAL Sotalex(Sotalol Hydrochloride) C 30 MG QD PO 80 MG QD PO 22-Aug-2005 Page: 349 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/03/01ISR Number: 3770209-9Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Other 2 CAPSU PT Company Report # Report Source Product Role Manufacturer Route Eskalith 300mg Capsules PS ORAL Vioxx 25mg Tablets SS ORAL Levothyroid C Duration Abdominal Pain Vomiting BID ORAL 1 TABLE DAILY ORAL Date:08/03/01ISR Number: 3771546-4Report Type:Expedited (15-DaCompany Report #LBID00201003224 Age:17 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE PT Report Source Product Role Manufacturer Route Aggression Condition Aggravated Literature Health Lithobid PS Solvay Pharmaceuticals ORAL Depersonalisation Depression Derealisation Disturbance In Attention Hallucination, Auditory Increased Appetite Insomnia Mania Nightmare Persecutory Delusion Post-Traumatic Stress Disorder Suicidal Ideation Thinking Abnormal Professional Risperidone (Risperidone) Paroxetine (Paroxetine) Date:08/06/01ISR Number: 3772057-2Report Type:Expedited (15-DaCompany Report #A117865 Age:46 YR Gender:Male I/FU:I C C Outcome Dose Duration Hospitalization 1200.00 MG Initial or Prolonged Other Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 350 10:48 AM PT Report Source Product Role Manufacturer Abdominal Pain Foreign Lithium Carbonate PS Pfizer Inc Blood Creatinine Increased Blood Urea Increased Chills Confusional State Dehydration Drug Level Above Therapeutic Dysarthria Extrapyramidal Disorder Hallucination Hypomania Malaise Paraplegia Sedation Tremor Urinary Incontinence Vomiting Literature Health Professional Nifedipine Enalapril Hydrochlorothiazide Amiloride Hydrochloride Metoprolol C C C C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/01ISR Number: 3772347-3Report Type:Expedited (15-DaCompany Report #2001013746-1 Age: Gender:Female I/FU:I Outcome Dose Disability PT Report Source Product Role Manufacturer Route Condition Aggravated Tremor Consumer Health Eskalith PS Smithkline Beecham Pharmaceuticals ORAL Duration 450 Professional MILLIGRAMS 2.0 DAILY ORAL 108 DAY Prozac (Fluoxetne Hcl) Xanax (Alprazolam) C C Date:08/09/01ISR Number: 3775048-0Report Type:Expedited (15-DaCompany Report #2001018512-1 Age:41 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1350 PT Report Source Product Role Manufacturer Route Pollakiuria Schizophrenia Consumer Eskalith Cr PS Smithkline Beecham Pharmaceuticals ORAL Thirst MILLIGRAMS ORAL Date:08/13/01ISR Number: 3776132-8Report Type:Expedited (15-DaCompany Report #PHEH2001USA06234 Age:51 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening Hospitalization 300 MG, ORAL Initial or Prolonged PT Report Source Product Role Manufacturer Route Anaemia Diabetes Mellitus Health Professional Clozaril PS Novartis Pharmaceuticals Corp ORAL Hyponatraemia Renal Disorder Renal Failure Lithium Carbonate (Lithium Carbonate) Lipitor (Atorvastatin) SS C Synthroid Prandin "Kuhn" (Defglazacort) Acupril (Quinapril) Boestrol C C C C Date:08/14/01ISR Number: 3777360-8Report Type:Expedited (15-DaCompany Report #2001UW09272 Age:23 YR Gender:Female I/FU:I Outcome Dose Disability 25 MG DAILY PT Report Source Product Role Manufacturer Route Headache Foreign Seroquel PS Astrazeneca Lp ORAL Insomnia Health Paraesthesia Professional Seroquel "Zeneca" SS Zeneca ORAL Serotonin Syndrome Other Vision Blurred Sertraline SS Vitamin B12 Abnormal Lithium SS Valproic Acid C Duration PO 25 MG DAILY PO ORAL 100 MG PO 900 MG HS Date:08/14/01ISR Number: 3777375-XReport Type:Direct Age:62 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600MG QD PT Product Role Dysarthria Feeling Jittery Lithium Carbonate (300 Mg) PS Movement Disorder Lisinopril (20mg) SS 20MG QD Tremor 22-Aug-2005 Page: 351 10:48 AM Company Report # Report Source Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/01ISR Number: 3778644-XReport Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG BID Other ORAL PT Company Report # Report Source Chorea Product Role Lithium Carbonate 300 Mg PS Quetiapine Vpa Clonidine Levothyroxine C C C C Manufacturer Route ORAL Date:08/17/01ISR Number: 3780326-5Report Type:Expedited (15-DaCompany Report #A109905 Age:45 YR Gender:Female I/FU:F Outcome Dose Duration Required Intervention to ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Neuroleptic Malignant Syndrome Health Professional Geodon PS Pfizer Central Research ORAL Route Lithium Nortryptiline Seroquel Propanolol Benadryl SS C C C C Date:08/20/01ISR Number: 3780769-XReport Type:Expedited (15-DaCompany Report #200114104DE Age:71 YR Gender:Female I/FU:F Outcome PT Dose Duration Death Atherosclerosis Life-Threatening Blood Creatinine INTRAVENOUS 40 MG/DAY IV 3 DAY Increased Body Temperature 2.5 MG / DAY Increased PO 2 DAY Dialysis Report Source Product Role Manufacturer Foreign Health Lasix PS Aventis Pharmaceuticals Inc Professional Other Ramipril (Delix) Tablets SS Lithium Carbonate ORAL Disseminated Intravascular Coagulation (Quilonum - Slow Release) SS ORAL Xipamide SS ORAL Pantoprazole Paraffin Petrolatum Wool Alcohols (Mineral Oil Light) (Aquaphor) Valproic Acid Mirtazapine (Remergil) Venlafaxine Hydrochloride (Trevilor) Atorvastatin Calcium (Sortis) Bisoprolol Fumarate (Concor) Allopurinol (Zyloric) Clopidogrel Sulfate (Iscover) Valproate Sodium C C C C 450 MG/ DAY Dizziness PO 11 MON Dyspnoea 10 MG / DAY Gastrointestinal Necrosis PO 11 MON Hypotension Hypovolaemia Ileus Paralytic Inflammation Intestinal Ischaemia Leukocytosis Multi-Organ Failure Myocardial Infarction Peritonitis Renal Artery Stenosis Renal Failure Acute Respiratory Failure Rhabdomyolysis Sepsis Shock Urea Urine Increased 22-Aug-2005 Page: 352 10:48 AM C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Ergenyl) Isosorbide Mononitrate (Ismo) Vitamin Nos, Amino Acids Nos, Electrolytes Nos (Tutofusin) Lithium Acetate (Quilonum) C C C C Date:08/23/01ISR Number: 3781908-7Report Type:Expedited (15-DaCompany Report #A0125593A Age:54 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 29 DAY Initial or Prolonged 15 YR PT Report Source Product Role Manufacturer Route Blood Pressure Decreased Lotronex PS Glaxo Wellcome ORAL Dehydration Lithium SS Drug Interaction Drug Toxicity Pyelonephritis Renal Failure Acute Nsaids SS Manufacturer Route Date:08/24/01ISR Number: 3782930-7Report Type:Expedited (15-DaCompany Report #A113136 Age:50 YR Gender:Female I/FU:F Outcome Dose Duration Required 120.00 MG Intervention to TOTAL:BID:ORA Prevent Permanent L Impairment/Damage 1800.00 MG PT Report Source Product Role Blood Creatinine Consumer Ziprasidone Po PS ORAL Lithium SS ORAL Sinemet Premarin Pepcid C C C Increased Blood Urea Increased Drug Level Above Therapeutic TOTAL:TID:ORA Muscle Rigidity L Tremor Flovent Levothyroxine Primidone Triazolam Date:08/24/01ISR Number: 3783662-1Report Type:Periodic Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 20 MG, QD, Initial or Prolonged ORAL 107 C C C C Company Report #PHEH2001US00585 PT Report Source Product Role Dehydration Diarrhoea Consumer Health Lotensin(Benazepril Hydrochloride) PS Drug Toxicity Professional Vomiting Company Lithium SS Representative Periactin (Cyproheptadine Hydrochloride) Amoxicillin Neurontin (Gabapentin) Glucophage "Merck" Synthroid Olanzapine Ativan DAY 22-Aug-2005 Page: 353 10:48 AM C C C C C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/01ISR Number: 3783442-7Report Type:Expedited (15-DaCompany Report #A0125593A Age:54 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Dehydration Drug Interaction Drug Toxicity Consumer Lotronex Tablet (Alosetron Hydrochloride) PS Proteinuria Pyelonephritis Renal Failure Acute Lithium Salt (Formulation Unknown) SS Staphylococcal Infection Nsaid (Formulation Unknown) SS Manufacturer Route ORAL ORAL 15 YR Date:08/29/01ISR Number: 3785217-1Report Type:Direct Age:8 YR Gender:Male I/FU:I Outcome Dose Duration Required Intervention to 60MG/DAY 40MG Prevent Permanent AM/20P / ORAL Impairment/Damage 750/DAY PT Company Report # Report Source Blood Pressure Decreased Heart Rate Increased Product Role Manufacturer Route Ziprasidone 20mg Pfizer PS Pfizer ORAL Lithium 150mg SS Clonidine C Hypotension Mental Impairment ORAL Sluggishness DIVIDE D TID Tachycardia / ORAL Tremor Date:08/29/01ISR Number: 3785591-6Report Type:Expedited (15-DaCompany Report #A119878 Age:66 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 300.00 MG Required TOTAL; DAILY; PT Report Source Product Role Arrhythmia Foreign Lithane Tablets PS Bundle Branch Block Right Literature Manufacturer Route ORAL Intervention to ORAL Prevent Permanent Impairment/Damage Cardiomegaly Health Drug Level Above Therapeutic Electrocardiogram Qt Prolonged Feeling Jittery Heart Rate Decreased Hyperhidrosis Hypotension Sedation Syncope Professional Haloperidol Carbamazepine Unspecified Benzodiazepines Enalapril Thyroxine C C C C C Date:08/31/01ISR Number: 3786710-8Report Type:Expedited (15-DaCompany Report #HQ5326329AUG2001 Age:42 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Decreased Appetite Endometriosis Menorrhagia Neoplasm Malignant Ovarian Cyst Consumer Effexor Xr (Venlafaxine Hydrochloride, Capsule, Extended Release) Effexor Xr (Venlafaxine Hydrochloride, Capsule, Extended Release) Role Manufacturer Route Duration PS ORAL SS ORAL SS ORAL 375 MG 1X PER 1 DAY Lithium (Lithium, ) 900 MG 1X PER 22-Aug-2005 Page: 354 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 DAY Lithium (Lithium) SS Vitamins C ORAL 600 MG 1X PER 1 DAY Date:08/31/01ISR Number: 3787083-7Report Type:Expedited (15-DaCompany Report #01-0052 Age:34 YR Gender:Male I/FU:F Outcome Dose Duration Death Hospitalization 250 MG, BID, Initial or Prolonged PO PT Report Source Product Role Manufacturer Route Anaphylactic Shock Atelectasis Other Pontal (Mefenamic Acid 250mg Capsules) PS ORAL Diarrhoea Disseminated Serenace (Haloperidol) SS ORAL Intravascular Coagulation Duodenal Ulcer Limas (Lithium Carbonate) SS ORAL Cardiac Failure 33MG, TID, PO 200 MG, TID, Enteritis PO Erythema Haematemesis Haemodialysis Liver Function Test Abnormal Melaena Muscular Weakness Oesophagitis Oliguria Pleural Effusion Pulmonary Embolism Pulmonary Mycosis Renal Failure Acute Rhabdomyolysis Sepsis Shock Staphylococcal Infection Vomiting Depas (Efizolam) Artane (Trihexyphenidyl Hydrochloride) Silece (Flunitrazepam) Impromen (Bromperidol) Remark (Betahistine Mesilate) C C C C C Date:08/31/01ISR Number: 3787736-0Report Type:Periodic Age:15 YR Gender:Male I/FU:F Outcome Dose Duration Required 40.00 MG Intervention to TOTAL:BID Prevent Permanent 1500.00 MG Impairment/Damage TOTAL:BID PT Report Source Product Role Grand Mal Convulsion Health Ziprasidone Po PS Sedation Professional Lithium Carbonate SS Clozaril C Date:08/31/01ISR Number: 3787818-3Report Type:Periodic Age:19 YR Gender:Male I/FU:F Outcome Dose Other Company Report #A109963 Manufacturer Route Company Report #A105389 PT Report Source Product Role Manufacturer Route Agitation Drug Ineffective Consumer Health Ziprasidone Po PS Pfizer Regulatory Safety ORAL Insomnia Professional Duration 80.00 MG TOTAL:BID:ORA Mania L Nausea Lithium Carbonate SS Clonazepam C 4500.00 MG Nervousness TOTAL:TID:ORA Psychotic Disorder L Vomiting 22-Aug-2005 Page: 355 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3788333-3Report Type:Periodic Age:22 YR Gender:Male I/FU:F Outcome Dose Other 20.00 MG Company Report #A109262 PT Report Source Product Role Manufacturer Route Nausea Health Ziprasidone Po PS ORAL Vomiting Professional Lithium Carbonate SS ORAL Risperdal SS ORAL Duration TOTAL:BID:ORA L 1200.00 MG TOTAL:DAILY:O RAL 4.00 MG TOTAL:BID:ORA L Date:09/03/01ISR Number: 3787682-2Report Type:Expedited (15-DaCompany Report #2001SE06327 Age:29 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 600 MG DAILY Hospitalization PO Initial or Prolonged 800 MG DAILY Required PO Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Convulsion Foreign Seroquel "Zeneca" PS ORAL Drug Interaction Health Epilepsy Professional Lithium SS ORAL Depakine C Other Date:09/05/01ISR Number: 3788594-0Report Type:Expedited (15-DaCompany Report #01P-028-0110397-00 Age: Gender:Female I/FU:I Manufacturer Route Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Glomerulonephritis Foreign Health Professional Epival Tablets (Depakote) (Divalproex Sodium) (Divalproex Sodium) PS Lithium SS Manufacturer Route ORAL 1.5 GM, 1 IN 1 D, PER ORAL Date:09/05/01ISR Number: 3788670-2Report Type:Expedited (15-DaCompany Report #2001018512-1 Age:41 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 1350 Initial or Prolonged MILLIGRAMS Other ORAL PT Report Source Product Role Manufacturer Route Mania Consumer Eskalith PS Smithkline Beecham ORAL Product Role Manufacturer Route Lithium Carbonate PS Dexedrine Risperidone Ddavp Hydroxyzine C C C C Pollakiuria Schizophrenia Thirst Date:09/06/01ISR Number: 3788781-1Report Type:Direct Age:11 YR Gender:Male I/FU:I Outcome Dose PT Company Report # Report Source Duration Abdominal Pain Upper 1200 MG / DAY Pain PO 1 DAY Psychogenic Pain Disorder 22-Aug-2005 Page: 356 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/01ISR Number: 3789907-6Report Type:Expedited (15-DaCompany Report #17812-141 Age:33 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 18 MON PT Report Source Product Role Dehydration Mania Foreign Literature Lithium: Strength & Manufacturer Unknown PS Muscle Twitching Nephritis Interstitial Oliguria Health Professional Carbamazepine: Strength & Manufacturer Unknown SS Manufacturer Route Manufacturer Route 300 MG Renal Failure BID-ROUTE NOT Sedation STATED 3 WK Stupor Tremor Date:09/10/01ISR Number: 3790263-8Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300 MG TID Initial or Prolonged ORAL Required 200 MG BID Intervention to ORAL Prevent Permanent Impairment/Damage PT Company Report # Report Source Drug Level Above Product Role Lithium 300 Mg PS ORAL Sulindac 200 Mg SS ORAL Therapeutic Dysarthria Gait Disturbance Date:09/11/01ISR Number: 3791435-9Report Type:Expedited (15-DaCompany Report #A120276 Age:26 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 80.00 MG PT Report Source Product Role Confusional State Health Ziprasidone Po PS Manufacturer Route ORAL Initial or Prolonged TOTAL:BID:ORA Coordination Abnormal Professional Drug Level Above L Therapeutic Lithium SS Effexor Xr Wellbutrin Topamax Parlodel C C C C ORAL 1200.00 MG Gastrointestinal Disorder TOTAL:BID:ORA Lethargy L Date:09/12/01ISR Number: 3792286-1Report Type:Expedited (15-DaCompany Report #2001018512-1 Age:41 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 1350 Initial or Prolonged MILLIGRAMS Other ORAL 5 YR PT Report Source Product Role Manufacturer Route Mania Consumer Eskalith PS Smithkline Beecham ORAL Risperdal (Risperidone) C Schizophrenia Date:09/13/01ISR Number: 3792490-2Report Type:Direct Age:60 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 357 10:48 AM PT Aphasia Clumsiness Dysphagia Movement Disorder Company Report # FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myotonia Tremor Report Source Dose Product Role Lithium(300mg) PS Manufacturer Route Manufacturer Route Duration 300MG 2 BID Date:09/14/01ISR Number: 3793838-5Report Type:Expedited (15-DaCompany Report #FLUV00301003707 Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Blood Calcium Decreased Blood Potassium Decreased Convulsion Foreign Health Professional Depromel 50 (Fluvoxamine Maleate) PS ORAL Depressed Level Of Other Rohypnol (Flunitrazepam) SS ORAL Contomin (Chlorpromazine Hydrochloride) SS ORAL Limas (Lithium Carbonate) SS ORAL 200 MG DAILY PO Consciousness Hyponatraemia 4 MG DAILY PO DAILY PO DAILY PO Date:09/14/01ISR Number: 3794038-5Report Type:Expedited (15-DaCompany Report #A120681 Age:64 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600.00 MG Initial or Prolonged TOTAL: DAILY Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Confusional State Foreign Lithane Tablets PS Hallucination Literature Nephrogenic Diabetes Insipidus Renal Tubular Disorder Restlessness Sleep Disorder Health Professional Thyroxine C Manufacturer Route Date:09/17/01ISR Number: 3794033-6Report Type:Direct Age:56 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG QHS Required ORAL Intervention to 40 MG QAM Prevent Permanent ORAL Impairment/Damage PT Company Report # Report Source Dizziness Drug Toxicity Product Role Manufacturer Route Lithium Carbonate 300 Mg PS ORAL Furosemide SS ORAL Nausea Sinus Bradycardia 40 Mg Date:09/17/01ISR Number: 3795971-0Report Type:Expedited (15-DaCompany Report #HQ5706209SEP2001 Age:3 MON Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Health Professional Efexor (Venlafaxine Hydrochloride) PS Efexor (Venlafaxine Hydrochloride SS Duration TRANSPLACENTAL Complications Of Maternal Exposure To Therapeutic 300 MG 1X PER Drugs 1 DAY Hypotonia TRANSPLACENTA L TRANSPLACENTAL 75 MG 1X PER 1 DAY TRANSPLACENTA 22-Aug-2005 Page: 358 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report L TRANSPLACENTAL Diazepam (Diazepam) SS Lithium (Lithium) SS 20 MG 1X PER 1 DAY TRANSPLACENTA L TRANSPLACENTAL 400 MG 1X PER 1 DAY TRANSPLACENTA L Date:09/18/01ISR Number: 3794161-5Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG PO TID Initial or Prolonged CHRONIC PT Company Report # Report Source Confusional State Product Role Lithium PS Manufacturer Route ORAL Mental Impairment Tremor Date:09/19/01ISR Number: 3795097-6Report Type:Direct Age:18 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 200MG TID Initial or Prolonged 450MG 2 Q 4PM PT Grand Mal Convulsion Date:09/19/01ISR Number: 3795422-6Report Type:Direct Age:64 YR Gender:Male I/FU:I Company Report # Report Source Product Role Seroquel PS Eskalith SS Company Report # Manufacturer Route Outcome Dose Duration Hospitalization 900MG PO BID Initial or Prolonged PT Report Source Product Role Difficulty In Walking Lithium Carbonate PS Drug Level Above Therapeutic Trazodone Risperidone Divalproex Restoril C C C C Manufacturer Route ORAL Date:09/19/01ISR Number: 3796333-2Report Type:Expedited (15-DaCompany Report #EMADSS2001005392 Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Hypernatraemia Foreign Health Professional Risperdal (Unspecified) (Risperidone) PS Manufacturer Route ORAL 2 MG, DAILY, ORAL Lithium (Lithium) Perphenan (Perphenazine) Date:09/20/01ISR Number: 3796131-XReport Type:Direct Age:29 YR Gender:Male I/FU:I Outcome Dose Duration Required Intervention to 60 MG PO BID Prevent Permanent STARTED 8/10 Impairment/Damage AT 20 MG PO 300MG PO BID AND THEN 22-Aug-2005 Page: 359 10:48 AM PT Drug Level Above Therapeutic SS C Company Report # Report Source Product Role Manufacturer Route Geodon (Ziprasidone) Pfizer PS Pfizer ORAL Lithium 300mg Po Bid SS Dysarthria Tremor ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report INCREASED SLOWLY Trilafon Haldol Lamictal Cogentin Synthroid Klonopin Rocaltrol Oystcal Mg Oxide Date:09/20/01ISR Number: 3796132-1Report Type:Direct Age:26 YR Gender:Female I/FU:I Outcome PT Dose Duration Life-Threatening Drug Toxicity 20 MG PO BID Hospitalization Extrapyramidal Disorder 600 MG PO BID 1 MON Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage C C C C C C C C C Company Report # Report Source Product Role Manufacturer Route Geodon PS ORAL Lithium SS ORAL Effexor Wellbutrin Sr Topamax Parlodel C C C C Date:09/20/01ISR Number: 3796557-4Report Type:Expedited (15-DaCompany Report #LBID00201003825 Age:26 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 900 MG BID PO Initial or Prolonged DAILY/ A FEW PT Report Source Product Role Diarrhoea Literature Lithium (Lithium) PS Dizziness Health Herbal Diurectic Otc SS Drug Level Above Professional Sinus Medication Otc (Sinus Medication Otc) SS WEEKS Therapeutic Gait Disturbance Nausea DAILY/ A FEW Manufacturer Route ORAL Nystagmus DAYS Sedation Tremor Risperidone (Risperidone) Propranolol (Propranolol) Lorazepam (Lorazepam) Sertraline (Sertraline) Hydroxyzine (Hydroxyzine) C C C C C Date:09/20/01ISR Number: 3796864-5Report Type:Expedited (15-DaCompany Report #LBID00201003849 Age:46 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization PO Initial or Prolonged 22-Aug-2005 Page: 360 10:48 AM PT Report Source Product Role Coordination Abnormal Literature Lithium (Lithium) PS Drug Level Above Therapeutic Intentional Misuse Renal Failure Acute Suicide Attempt Health Professional Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/01ISR Number: 3797916-6Report Type:Expedited (15-DaCompany Report #2001021576-1 Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900 PT Report Source Product Role Manufacturer Agitation Confusional State Literature Health Lithium Smithkline Beecham PS Smithkline Beecham Coordination Abnormal Professional Candesartan C Route MILLIGRAMS Disorientation Drug Interaction Drug Level Above Therapeutic Drug Toxicity Date:09/24/01ISR Number: 3798162-2Report Type:Expedited (15-DaCompany Report #2001015173-1 Age:70 YR Gender:Male I/FU:I Outcome Dose Disability PT Report Source Product Role Manufacturer Route Disorientation Drug Interaction Consumer Health Relafen Smithkline Beecham PS Smithkline Beecham ORAL Dyspnoea Memory Impairment Oedema Peripheral Professional Esaklith Cr (Lithium Carbonate) Smithkline Beecham SS Smithkline Beecham ORAL Flomax (Tamsulosin Hcl) C Manufacturer Route Duration ORAL 450 Tremor MILLIGRAMS 1.0 DAILY ORAL Date:09/24/01ISR Number: 3799647-5Report Type:Periodic Age:70 YR Gender:Female I/FU:I Outcome Dose PT Duration Company Report #WAES 01082050 Report Source Product Role Tremor Consumer Tab Vioxx 12.5 Mg PS Eskalith Unk Sinement SS C ORAL 12.5 MG/DAILY/PO Date:09/25/01ISR Number: 3798365-7Report Type:Expedited (15-DaCompany Report #2001018512-1 Age:41 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1350 Other MILLIGRAMS, PT Report Source Product Role Manufacturer Route Depression Mania Consumer Eskalith Smithkline Beecham PS Smithkline Beecham ORAL Risperdal (Risperidone) C Manufacturer Route Pollakiuria Schizophrenia ORAL 5 YR Sedation Thirst Date:09/25/01ISR Number: 3800113-9Report Type:Direct Age:65 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG TWICE Initial or Prolonged DAILY ORAL PT Blood Creatinine 10:48 AM Report Source Product Role Lithium 300mg PS Olanzapine Hydrochlorothiazide Ranitidine Hytrin C C C C Increased Diabetes Insipidus Fall Tremor Urinary Incontinence 22-Aug-2005 Page: 361 Company Report # ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/01ISR Number: 3801247-5Report Type:Expedited (15-DaCompany Report #2001021764-1 Age:25 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MILLIGRAMS 5 PT Report Source Product Electromyogram Abnormal Hypokalaemia Literature Health Lithium Beecham Muscular Weakness Professional Role Manufacturer PS Smithkline Beecham Route Smithkline YR Paralysis Flaccid Buspirone Fluoxetine (Fluoxetine) C C Date:09/25/01ISR Number: 3801301-8Report Type:Expedited (15-DaCompany Report #PHEH2001US07720 Age:15 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 200 MG, ORAL 900 MG 13 PT Report Source Product Role Blood Creatinine Increased Health Professional Clozaril(Clozapine) Tablet PS Drug Level Above Lithium(Lithium) SS Therapeutic Leukocytosis Pyrexia Red Blood Cell Sedimentation Rate Increased Geodon (Ziprasidone Hydrochloride) Depakote (Valproate Semisodium) Acetaminophen (Paracetamol) Ibuprofen Chloral Hydrate Manufacturer Route ORAL DAY C C C C C Date:09/26/01ISR Number: 3799914-5Report Type:Expedited (15-DaCompany Report #0519635A Age:76 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1 SOFTGEL/PRN/P PT Report Source Product Role Manufacturer Route Medication Error Tremor Consumer Gas-X Simethicone 125mg Nvch PS Nvch ORAL O Lithium-Smithkline Beecham SS Lithium Synthroid Fosamax C C C Smithkline Beecham ORAL UNK/UNK/PO Date:09/26/01ISR Number: 3799915-7Report Type:Expedited (15-DaCompany Report #0519635A Age:76 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1 PT Report Source Product Role Manufacturer Route Medication Error Tremor Consumer Gas-X-Simethicone 125mg Nvch PS Nvch ORAL Lithium Smithkline Beecham SS Smithkline Beecham ORAL Lithium Synthroid Fosamax C C C SOFTGEL/PRN/P O UNK/UNK/PO 22-Aug-2005 Page: 362 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/01ISR Number: 3800305-9Report Type:Direct Age:65 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Company Report # Report Source Delirium Drug Toxicity Hypovolaemia Movement Disorder Muscle Twitching Product Role Lithium Oxcarbamazepine Olanzepine Lisinopril Felodipine Glyburide PS C C C C C Manufacturer Route Manufacturer Route Date:09/26/01ISR Number: 3801892-7Report Type:Expedited (15-DaCompany Report #FLUV00301003707 Age:54 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 200 MG DAILY Initial or Prolonged PO 2 YR 2 MG DAILY PO DAILY PO DAILY PO 2 2 2 PT Report Source Product Role Convulsion Foreign Depromel 50 PS ORAL Depressed Level Of Health Consciousness Electrolyte Imbalance Professional Other Rohypnol (Flunitrazepam) SS ORAL Hypocalcaemia Hypochloraemia Hypokalaemia Contomin (Chlorpromazine Hydrochloride) SS ORAL Hyponatraemia Polyuria Limas (Lithium Carbonate) SS ORAL YR YR YR Date:09/27/01ISR Number: 3800426-0Report Type:Expedited (15-DaCompany Report #2001022226-1 Age: Gender: I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Pancreatitis Health Professional Eskalith Smithkline Beecham PS Smithkline Beecham Duration Route Date:09/28/01ISR Number: 3802136-2Report Type:Expedited (15-DaCompany Report #NSADSS2001028418 Age:57 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE PT Report Source Product Role Manufacturer Route Confusional State Coordination Abnormal Study Health Topiramate (Tablet) (Topiramate) PS ORAL Decreased Appetite Drug Toxicity Professional Lithium Carbonate (Lithium Carbonate) SS ORAL 900 MG, 2 IN Dysgeusia 1 DAY (S), ORAL Date:09/28/01ISR Number: 3803107-2Report Type:Direct Age: Gender:Not SpecifiI/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 363 10:48 AM PT Intentional Misuse Lethargy Sedation Suicide Attempt Company Report # Report Source Product Role Lithium PS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/01ISR Number: 3803159-XReport Type:Expedited (15-DaCompany Report #A121985 Age:33 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600.00 MG PT Report Source Product Role Blood Pressure Decreased Blood Sodium Decreased Foreign Literature Lithane Tablets Carbamazepine PS SS Dehydration Health Haemodialysis Mania Muscle Twitching Nephritis Interstitial Oliguria Pulmonary Oedema Renal Failure Sedation Sinus Tachycardia Stupor Therapeutic Agent Toxicity Tremor Professional Manufacturer Route Manufacturer Route TOTAL:BID Date:10/01/01ISR Number: 3804122-5Report Type:Expedited (15-DaCompany Report #LBID00201003893 Age:59 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG BID PO Initial or Prolonged PT Report Source Product Role Agitation Literature Lithium PS Delirium Dizziness Dyspnoea Electrocardiogram Abnormal Electrocardiogram Qt Shortened Headache Hypercalcaemia Hypermagnesaemia Hyperparathyroidism Hypertension Hypophosphataemia Nausea Health Professional Fluphenazine (Fluphenazine) (Benztropine Mesylate) Aspirin Compound C C C ORAL Polyuria Tachycardia Urine Abnormality Date:10/01/01ISR Number: 3804162-6Report Type:Expedited (15-DaCompany Report #LBID00201003889 Age:59 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 364 10:48 AM PT Abnormal Behaviour Constipation Diarrhoea Disorientation Disturbance In Attention Electroencephalogram Abnormal Encephalopathy Medication Error Memory Impairment Obsessive Thoughts Paranoia FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Incontinence Dose Report Source Product Role Manufacturer Route Literature Health Professional Lithium, Manufacturer Unknown (Lithium) PS ORAL Olanzapine (Olanzapine) SS ORAL Haloperidol (Haloperidol) SS ORAL (Carbamazepine) C Duration 900 MG DAILY PO 5 MG DAILY PO 20 MG DAILY PO Date:10/02/01ISR Number: 3803393-9Report Type:Direct Age:40 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG QD 1 YR Initial or Prolonged PT Company Report # Report Source Product Role Coordination Abnormal Lithium PS Depressed Level Of Consciousness Drug Level Above Therapeutic Renal Failure Acute Tremor Cogentin Haldol Olanzapine Propranolol Bactrim C C C C C Manufacturer Route Route Date:10/03/01ISR Number: 3803376-9Report Type:Expedited (15-DaCompany Report #B0121705A Age:55 YR Gender:Male I/FU:I Outcome Dose Death RESPIRATORY PT Report Source Product Role Manufacturer Agitation Foreign Salbutamol PS Glaxo Wellcome Duration Arrhythmia (INHALATION) UNKNOWN Bipolar I Disorder 5MG Three Blood Phosphorus Procyclidine SS Increased 60MG Weekly Confusional State 225MG See Coronary Artery Disease Flupenthixol SS Quetiapine SS Delusion 400MG Three Drug Level Above Sandocal SS Therapeutic 1.25MG In the Irritability Ramipril SS Speech Disorder 1MCG Per day Sudden Death 5MG Three Alfacalcidol SS Diazepam SS Chlorpromazine Hydrochloride SS Lorazepam SS Lithium SS Glaxo Wellcome times per day UNKNOWN UNKNOWN text UNKNOWN times per day UNKNOWN morning UNKNOWN UNKNOWN times per day UNKNOWN PARENTERAL UNKNOWN 15 DAY Date:10/03/01ISR Number: 3803422-2Report Type:Direct Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 365 10:48 AM PT Bradycardia Dialysis Drug Toxicity Dysarthria Mental Impairment Company Report # Glaxo Wellcome FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Nephrogenic Diabetes Insipidus Dose Report Source Product Role Lithium PS Carbamzepine Gemfibrozil Resperidone Terazosin Acetaminophen Lantoprost Opth Timolol Opth C C C C C C C Manufacturer Route Duration Vomiting ORAL 240 MG TID PO Date:10/03/01ISR Number: 3803697-XReport Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 900MG PO QD Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Product Role Anxiety Lithium PS Confusional State Diarrhoea Dissociation Drug Toxicity Dry Mouth Dysarthria Fatigue Mental Impairment Micturition Urgency Movement Disorder Nausea Polyuria Renal Failure Speech Disorder Thirst Tongue Disorder Tremor Vomiting Cotrimoxazole Citalopram Fluconazole Mirtazipine C C C C Date:10/03/01ISR Number: 3804320-0Report Type:Expedited (15-DaCompany Report #01P-163-0104719-00 Age:42 YR Gender:Male I/FU:F Manufacturer Route ORAL Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Chronic Obstructive Airways Disease Exacerbated Delirium Tremens Drug Interaction Health Professional Kaletra Soft Gelatin Capsules (Kaletra) (Lopinavir/Ritonavir ) (Lopinavir/Ritonavir PS Manufacturer Route ORAL 3 TABLET, 2 Dyspnoea IN 1 D, PER Renal Tubular Acidosis ORAL Respiratory Alkalosis 11 MG, Amprenavir Lithium (Lithium) Coumadin (Warfarin Sodium) SS SS Agenerase Ipratropium Bromide Salmeterol Xinafoate Lithium Carbonate Metoprolol Benazepril Hydrochloride C C C C C SS IN 1 D, PER ORAL 22-Aug-2005 Page: 366 10:48 AM C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amfebutamone Hydrochloride Combivir Warfarin Sodium Salbutamol C C C C Date:10/03/01ISR Number: 3804463-1Report Type:Expedited (15-DaCompany Report #2001018512-1 Age:41 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1350 Other MILLIGRAMS PT Report Source Product Role Manufacturer Route Condition Aggravated Depression Consumer Eskalith Smithkline Beecham PS Smithkline Beecham ORAL SS Smithkline Beecham Hallucination, Visual Libido Decreased ORAL 5 YR Mania Pollakiuria Psychotic Disorder Schizophrenia Sedation Thirst Eskalith Smithkline Beecham Risperdal (Risperidone) C Date:10/03/01ISR Number: 3806839-5Report Type:Expedited (15-DaCompany Report #EMADSS2001005486 Age:48 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening 10 CAP, DAILY PT Report Source Product Role Manufacturer Blood Creatine Foreign Topiramate PS ORAL Phosphokinase Increased Study Body Temperature Health Placebo (Placebo) SS ORAL Increased Professional Risperidone (Risperidone) SS Route ORAL 10 CAP, DAILY, ORAL Catatonia Headache PATIENT HAD Muscle Rigidity PREVIOUSLY Neuroleptic Malignant RECEIVED Syndrome RISPERIDONE Respiratory Failure FROM Lithium (Lithium) SS 10 CAP, DAILY, ORAL Lorazepam (Lorazepam) Chloral Hydrate (Chloral Hydrate) Diazepam (Diazepam) Olanzapine (Olanzapine) Senna (Senna) Lactulose (Lactulose) Haloperidol (Haloperidol) Lithium Carbonate (Lithium Carbonate) Date:10/04/01ISR Number: 3805329-3Report Type:Expedited (15-DaCompany Report #LBID00201003968 Age:64 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 367 10:48 AM PT Dehydration Drug Level Above C C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Inappropriate Affect Dose Report Source Product Role Literature Lithium (Lithium) PS Manufacturer Route Duration ORAL DAILY PO Health Professional Date:10/04/01ISR Number: 3805518-8Report Type:Expedited (15-DaCompany Report #LBID00201003969 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization DAILY PO Initial or Prolonged PT Report Source Product Role Drug Level Above Literature Lithium (Lithium) PS Therapeutic Euphoric Mood Haemodialysis Tremor Health Professional Date:10/05/01ISR Number: 3806077-6Report Type:Direct Age: Gender: I/FU:I Outcome Dose Other PT Route ORAL Company Report # Report Source Product Role Lithium Carbonate PS Manufacturer Route Manufacturer Route Duration Tremor Date:10/05/01ISR Number: 3806078-8Report Type:Direct Age: Gender: I/FU:I Outcome Dose Other Manufacturer PT Company Report # Report Source Product Role Lithium PS Duration Drug Level Above Therapeutic Date:10/05/01ISR Number: 3806816-4Report Type:Expedited (15-DaCompany Report #2001022308-1 Age:36 YR Gender:Female I/FU:I Outcome Dose Other SEE IMAGE PT Report Source Product Role Manufacturer Crying Disturbance In Attention Health Professional Lithium Smithkline Beecham PS Smithkline Beecham Fluoxetine C Route Duration 5 DAY Drug Interaction Fatigue Serotonin Syndrome Date:10/05/01ISR Number: 3807415-0Report Type:Expedited (15-DaCompany Report #2001UW12244 Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Required 50 MG DAILY Intervention to PO 8 DAY Prevent Permanent 750 MG DAILY Impairment/Damage PO 5 YR PT Report Source Product Role Blood Urea Increased Foreign Seroquel "Zeneca" PS ORAL Confusional State Other Lithium SS ORAL Diovan SS ORAL Lorazepam Ciproflaxacin Conjugated Estrogens Glyburide L-Typtophan Zopiclone C C C C C C Coordination Abnormal Delusion Drug Level Above 2 WK Therapeutic Mania Sedation 22-Aug-2005 Page: 368 10:48 AM Route Delirium 80 MG DAILY PO Manufacturer FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/01ISR Number: 3806864-4Report Type:Expedited (15-DaCompany Report #1633168A Age:39 YR Gender:Female I/FU:I Outcome Dose Duration Death Hospitalization PO Initial or Prolonged PO Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Activated Partial Thromboplastin Time Literature Health Acetaminophen Product PS ORAL Prolonged Professional Lithium SS ORAL Manufacturer Route Acute Respiratory Distress Syndrome Ammonia Increased Anion Gap Increased Aspartate Aminotransferase Increased Blood Bicarbonate Decreased Blood Bilirubin Increased Blood Calcium Decreased Blood Glucose Decreased Brain Oedema Drug Level Above Therapeutic Electroencephalogram Abnormal Encephalopathy Gastrointestinal Haemorrhage Hyperreflexia Orthostatic Hypotension Vomiting White Blood Cell Count Increased Date:10/08/01ISR Number: 3806865-6Report Type:Expedited (15-DaCompany Report #1633417A Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Death Hospitalization "3 MONTHS PT Report Source Product Role Bradycardia Coagulopathy Literature Health Unspecified Tylenol Product PS Manufacturer Route ORAL Initial or Prolonged WORTH" PO; Required ACUTE-ON-CHRO Intervention to NIC Prevent Permanent "3 MONTHS Impairment/Damage WORTH" PO; Coma Professional Drug Level Above Therapeutic Gastrointestinal Disorder Lithium SS Hepatic Failure Hypotension ACUTE-ON-CHRO NIC Effexor (Venlafaxine) Stelazine (Trifluoperazine) Metoprolol Lamictal (Lamotrigine) Unspecified Valproic Acid Product 22-Aug-2005 Page: 369 10:48 AM C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/01ISR Number: 3807641-0Report Type:Expedited (15-DaCompany Report #NSADSS2001029546 Age:41 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Literature Health Haldol (Unspecified) (Haloperidol) PS Professional Lithium (Lithium) SS Manufacturer Route Duration ORAL ORAL Date:10/09/01ISR Number: 3805423-7Report Type:Expedited (15-DaCompany Report #A0162626A Age:50 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900MG Per day 5 YR PT Report Source Product Role Manufacturer Route Balance Disorder Blood Potassium Abnormal Wellbutrin Eskalith Cr PS SS Glaxo Wellcome Glaxo Wellcome ORAL ORAL Blood Sodium Abnormal Zyprexa SS Condition Aggravated Prilosec SS Manufacturer Route UNKNOWN UNKNOWN Diplopia Disorientation Electrolyte Imbalance Fall Tremor Date:10/09/01ISR Number: 3805617-0Report Type:Direct Age:66 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Dehydration Drug Toxicity Hypercalcaemia Hypernatraemia Mental Impairment Nephrogenic Diabetes Insipidus Pneumonia Aspiration Company Report # Report Source Product Role Lithium PS ORAL Date:10/10/01ISR Number: 3809150-1Report Type:Expedited (15-DaCompany Report #2001023091-1 Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization SEE IMAGE 5 YR Initial or Prolonged PT Report Source Product Role Manufacturer Route Balance Disorder Consumer Eskalith PS Smith Beecham ORAL SS SS Glaxowellcome Lilly SS Astrazeneca Condition Aggravated Diplopia Disorientation Electrolyte Imbalance Fall Tremor Wellbutrin (Bupropion) Zyprexa Prilosec (Omeprazole) Date:10/10/01ISR Number: 3810020-3Report Type:Expedited (15-DaCompany Report #2001AP03838 Age:55 YR Gender:Male I/FU:I Outcome Death 22-Aug-2005 Page: 370 PT Agitation Arrhythmia Bipolar I Disorder Blood Phosphorus Increased Chest Pain Confusional State 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Coronary Artery Disease Delusion Drug Level Above Report Source Product Role Manufacturer Therapeutic Dyspnoea Emotional Distress Foreign Health Professional Salbutamol PS Astrazeneca Pharmaceuticals Ramipril SS ORAL Irritability Other Left Ventricular Failure Quetiapine SS ORAL Mania Quetiapine SS ORAL Respiratory Failure Depixol SS Speech Disorder Sandocal "Novartis" SS ORAL Sudden Death Alfacalcidol SS ORAL Diazepam SS ORAL Procyclidine SS Chlorpromazine Lorazepam Lithium SS SS SS Route Duration 1.25 MG DAILY PO 75 MG HS PO 150 MG HS PO 60 MG WEEK 400 MG TID PO 1 UG DAILY PO 5 MG TID PO 5 MG TID Date:10/10/01ISR Number: 3810507-3Report Type:Expedited (15-DaCompany Report #B0121705A Age:55 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Agitation Arrhythmia Bipolar I Disorder Foreign Ventolin Unspecified Inhaler Device (Albuterol Sulfate) PS Kemadrin (Formulation Unknown) (Procyclidine Hcl) SS Duration RESPIRATORY (INHALATION) 5 MG / THREE Blood Phosphorus INHALED Increased Confusional State Coronary Artery Disease Delusion Manufacturer Route Irritability TIMES PER DAY Speech Disorder / Sudden Death 60 MG Flupenthixol (Formulation Unknown) (Flupenthixol) SS Quetiapine (Formulation Unknown) (Quetiapine) SS Sandocal (Formulation Unknown) (Sandocal) SS Ramipril (Formulation Unknown) (Ramipril) SS Alfacalcidol (Formulation Unknown) (Alfacalcidol) SS Diazepam (Formulation Unknown) (Diazepam) SS / WEEKLY 225 MG / SEE TEXT 400 MG / THREE TIMES PER DAY 1.25 MG / IN THE MORNING / 1 MCG / PER DAY 5 MG / THREE TIMES PER DAY 22-Aug-2005 Page: 371 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam (Formulation Unknown) (Lorazepam) PARENTERAL Lithium Salt (Formulation Unknown) (Lithium Salt) Chlorpromazine Hcl (Formulation Unknown) (Chlorpromazine Hcl) Date:10/11/01ISR Number: 3807612-4Report Type:Direct Age:54 YR Gender:Male I/FU:I Outcome Dose Other SS PARENTERAL PT SS SS Company Report # Report Source Product Role Lithium PS Manufacturer Route Manufacturer Route Duration Agitation Delirium Date:10/11/01ISR Number: 3807702-6Report Type:Direct Age:49 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 300 MG PO BID PT Company Report # Report Source Product Role Drug Level Above Lithium (300mg) PS ORAL Therapeutic Lisinopril SS ORAL 10 MG PO Feeling Jittery DAILY Hypotension Lethargy Mental Impairment Polyuria Date:10/11/01ISR Number: 3808265-1Report Type:Expedited (15-DaCompany Report #NSADSS2001028418 Age:57 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1) 25 MG, 2 PT Report Source Product Role Manufacturer Route Confusional State Coordination Abnormal Study Health Topiramate (Tablet) (Topiramate) PS ORAL Decreased Appetite Professional Lithium Carbonate (Lithium Carbonate) SS ORAL IN 1 DAY(S), Drug Toxicity PO; 2) 50 MG, Dysgeusia 2 IN 1 DAY(S), PO; 900 MG, 2 IN 1 DAY(S), ORAL Date:10/16/01ISR Number: 3809852-7Report Type:Direct Age:33 YR Gender:Male I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage 600 MG QHS PO PT Leukocytosis Company Report # Report Source Product Role Manufacturer Route Lithobid (600 Mg) (Solvay Pharmaceuticals) PS Solvay Pharmaceuticals ORAL Clozapine (400mg) SS Klonopin C (400 MG) BID PO 22-Aug-2005 Page: 372 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonidine Cogentin Date:10/16/01ISR Number: 3809867-9Report Type:Direct Age: Gender: I/FU:I Outcome Dose Other PT C C Company Report # Report Source Product Role Lithium PS Manufacturer Route Manufacturer Route Duration Tremor Date:10/16/01ISR Number: 3809913-2Report Type:Expedited (15-DaCompany Report #2001-08-1173 Age:55 YR Gender:Male I/FU:F Outcome Dose Duration Death Hospitalization Initial or Prolonged RESPIRATORY (INHALATION) INTRAMUSCULAR PT Report Source Product Role Agitation Arrhythmia Blood Phosphorus Foreign Health Professional Salbulin Hfa (Salbutamol) Oral Aerosol PS Depixol Injectable SS Ramipril Capsules SS ORAL Alfacalcidol Tablets SS ORAL Diazepam Tablets SS ORAL Procyclidine Tablets SS ORAL Quetiapine Fumurate SS Sandocal Tablets SS Lorazepam Injectable SS Increased ORAL AER INH Delusion 60MG QWEEK* Irritability Other INTRAMUCULAR Mania 1.25 MG QAM Speech Disorder ORAL Sudden Death 1MCG QD ORAL 15MG TID ORAL 15MG TID ORAL 225MG QD 400MG TID ORAL ORAL Lithium SS .... C ORAL ORAL INTRAMUSCULAR 60MG QWEEK INTRAMUSCULAR Date:10/16/01ISR Number: 3810213-5Report Type:Expedited (15-DaCompany Report #11008554 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 500 PT Report Source Product Role Manufacturer Route Leukocytoclastic Vasculitis Foreign Health Nefadar Tabs(Nefazodone Hcl) PS ORAL Liver Function Test Professional Abnormal Company Pyrexia Representative Other Quilonum Ilithium Carbonate) SS ORAL Ximovan (Zopiclone) SS ORAL Diazepam (Diazepam) Calcium (Calcium) C C MILLIGRAM, 1 DAY, ORAL 450 MILLIGRAM, 1 DAY , ORAL 7.5 MILLIGRAM, 1 DAY , ORAL Date:10/16/01ISR Number: 3810407-9Report Type:Expedited (15-DaCompany Report #2001021558-1 Age: Gender:Male I/FU:I Outcome Other 22-Aug-2005 Page: 373 PT Bone Marrow Depression Haematocrit Decreased Megakaryocytes Abnormal 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myeloproliferative Disorder Dose Report Source Product Role Manufacturer Route Health Professional Eskalith Smithkline Beecham PS Smithkline Beecham ORAL Manufacturer Route Duration 300 MILLIGRAMS 4.0 DAILY ORAL Cogentin (Benztropine Mesylate) Norvasc (Amlodipine Besylate) Diovan (Valsartan) Potassium Chloride C C C C Date:10/16/01ISR Number: 3810515-2Report Type:Expedited (15-DaCompany Report #A0162626A Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Balance Disorder Condition Aggravated Diplopia Disorientation Consumer Wellbutrin Unspecified Tablet (Bupropion Hydrochloride) PS ORAL Lithium Carbonate (Formulation Unknown) (Lithium Carbonate) SS ORAL ORAL Electrolyte Imbalance Fall Tremor 900 MG / PER DAY / ORAL Olanzapine (Formulation Unknown) (Olanzapine) Omeprazole (Formulation Unknown) SS (Omeprazole) SS Date:10/18/01ISR Number: 3811418-XReport Type:Expedited (15-DaCompany Report #2001023197-1 Age:55 YR Gender:Male I/FU:I Outcome Dose Death 15 PT Report Source Product Role Manufacturer Agitation Arrhythmia Lithium Smithkline Beecham PS Smithkline Beecham Confusional State Delusion Drug Level Above Therapeutic Irritability Mental Impairment Speech Disorder Alfacalcidol Calcium Carbonate X/Calcium Carbonate (Sandocal) Chlorpromazine Diazepam Flupenthixol (Depixol) Lorazepam Procyclidine Quetiapine Ramipril Salbutamol Duration DAY 22-Aug-2005 Page: 374 10:48 AM C C C C C C C C C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/01ISR Number: 3811572-XReport Type:Expedited (15-DaCompany Report #HQ6829008OCT2001 Age:55 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Health Professional Ativan (Lorazepam, Injection) PS Other Chlorpromazine (Chlorpromazine) Depixol (Flupentixol Decanoate) Duration PARENTERAL Agitation Arrhythmia PARENTERAL Coronary Artery Atherosclerosis Delusion Drug Level Above SS SS 60 MG 1 X PER Therapeutic 1 WK Irritability Diazepam (Diazepam) SS Mental Impairment Lithium (Lithium) SS Speech Disorder Sudden Death Procyclidine (Procyclidine) SS Quetiapine (Quetiapine) SS Salbutamol (Salbutamol) SS Sandocal (Calcium Glubionate) SS 5 MG 3 X PER Medication Error 1 DAY 15 DAY 5 MG 3 X PER 1 DAY 225 MG 1 X PER 1 DAY RESPIRATORY (INHALATION) INHALATION 400 MG 3 X PER 1 DAY Date:10/18/01ISR Number: 3811730-4Report Type:Expedited (15-DaCompany Report #001-0902-M0100096 Age: Gender:Male I/FU:I Manufacturer Route Outcome Dose Duration Hospitalization Initial or Prolonged 15 MG Other (DAILY), PER PT Report Source Product Role Balance Disorder Bipolar Disorder Consumer Nardil (Phenelzine Sulfate) PS Cardiac Disorder Coordination Abnormal ORAL Diabetes Mellitus Non-Insulin-Dependent Difficulty In Walking Drug Ineffective Fear Pain Weight Increased Zoloft (Sertraline Hydrochloride) Prozac (Fluoxetine Hydrochloride) Lithium (Lithium) Effexor Xr (Venlafaxine) SS SS SS SS 375 MG Paxil (Paroxetine Hydrochloride) Pamate (Tranylcypromine) (Unspecified Thyroid Medication) Effexor (Venlafaxine Hydrochloride) Date:10/18/01ISR Number: 3811775-4Report Type:Expedited (15-DaCompany Report #A123617 Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 375 10:48 AM PT Balance Disorder Bipolar Disorder Coordination Abnormal Diabetes Mellitus Non-Insulin-Dependent SS SS SS SS Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Difficulty In Walking Drug Ineffective Fear Dose Report Source Product Role Consumer Zoloft Tablets Lithium Phenelzine PS SS SS Prozac (Fluoxetine) Effexor Xr Paxil (Paroxetine) Tranylcypromine Unspecified Thyroid Medication Effexor (Venlafaxine) SS C C C Manufacturer Route Duration Pain Palpitations Weight Increased ORAL 15.00 MG TOTAL: DAILY: ORAL C C Date:10/19/01ISR Number: 3812211-4Report Type:Expedited (15-DaCompany Report #EMADSS2001006022 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Blood Disorder Foreign Health Professional Risperdal (Unspecified) (Risperidone) Mirtazapine (Mirtazapine) Lithium Role Manufacturer Route Manufacturer Route Duration PS SS SS Date:10/19/01ISR Number: 3812213-8Report Type:Expedited (15-DaCompany Report #APCDSS2001001339 Age:93 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 0.5 MG, 2 IN PT Report Source Product Role Clonic Convulsion Coma Depressed Level Of Foreign Health Professional Risperdal (Unspecified) (Risperidone) PS ORAL Consciousness Company Drug Interaction Representative 1 DAY (S), ORAL; 1 MG, 2 Lethargy IN 1 DAY (S), Muscle Rigidity ORAL Lithium (Lithium) 250 MG, 2 IN 1 DAY (S), ORAL; 500 MG, 2 IN 1 DAY (S), ORAL Date:10/19/01ISR Number: 3812574-XReport Type:Expedited (15-DaCompany Report #K200100247 Age:55 YR Gender:Male I/FU:F Outcome Death 22-Aug-2005 Page: 376 PT Abnormal Behaviour Agitation Arrhythmia Bipolar I Disorder Condition Aggravated Coronary Artery Disease Drug Level Above Therapeutic Irritability 10:48 AM SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Medication Error Speech Disorder Dose Report Source Product Role Manufacturer Route Foreign Health Altace Capsules (Ramipril) PS ORAL Diazepam (Diazepam) SS ORAL Salbutamol (Salbutamol) SS ORAL Depixol (Flupentixol Decanoate) SS Quetiapine (Quetiapine) SS Sandocal (Calcium Carbonate, Colecaliferol, Sodium) SS Alfacalidol (Alfacalcidol) SS Procyclidine (Procyclidine) SS Duration 1.25 MG, QD, Professional ORAL Other 5 MG, TID, ORAL ORAL 60 MG, Q WEEK ORAL 225 MG, QD, ORAL 400 MG, TID 1 UG 15 MG, QD Chlorpromazine (Chlorpromazine) Lorazepam (Lorazepam) Lithium (Lithium) Date:10/24/01ISR Number: 3817627-8Report Type:Periodic Age:58 YR Gender:Male I/FU:F Company Report #1998007471-1 SS SS SS Novartis Outcome Dose Duration Life-Threatening Hospitalization ORAL 8 YR Initial or Prolonged Required 450 Intervention to MILLIGRAMS Prevent Permanent 2.0 DAILY Impairment/Damage ORAL PT Report Source Product Role Manufacturer Route Coronary Artery Disease Heart Rate Decreased Health Professional Eskalith Smithkline Beecham PS Smithkline Beecham ORAL Eskalith Smithkline Beecham C Smithkline Beecham ORAL Lithobid (Lithium Carbonate) C Route Date:10/24/01ISR Number: 3818948-5Report Type:Expedited (15-DaCompany Report #2001024864-1 Age:46 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 377 10:48 AM PT Report Source Product Role Manufacturer Coma Coordination Abnormal Drug Toxicity Intentional Misuse Renal Failure Acute Suicide Attempt Literature Health Professional Lithium Carbonate (Lithium) Glaxosmithkline PS Glaxosmithkline FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/01ISR Number: 3817130-5Report Type:Expedited (15-DaCompany Report #01P-062-0111690-00 Age:52 YR Gender:Female I/FU:I Outcome PT Dose Duration Required Agitation Intervention to Blood Creatinine Prevent Permanent Increased Impairment/Damage Blood Osmolarity INTRAVENOUS INTRAVENOUS Increased 1250 MG, 1 IN Coma 1 D Diabetes Insipidus Drug Level Above Therapeutic Hypernatraemia Mania Paranoia Sedation Stupor Urinary Retention Report Source Product Role Foreign Literature Health Professional Valproic Acid Iv (Depacon) (Valproate Sodium) (Valproate Sodium) PS Other Lithium SS Perazine Zotepine Lorazepam C C C Manufacturer Route Manufacturer Route Date:10/31/01ISR Number: 3818516-5Report Type:Expedited (15-DaCompany Report #FLUV00301003707 Age:54 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Body Temperature Increased Convulsion Foreign Health Professional Depromel 50 (Fluvoxamine Maleate) PS ORAL Dehydration Other Depressed Level Of Consciousness Rohypnol (Flunitrazepam) SS ORAL Diabetes Insipidus Electrolyte Imbalance Hypocalcaemia Contomin (Chlorpromazine Hydrochloride) SS ORAL Hypochloraemia Hypokalaemia Limas (Lithium Carbonate) SS ORAL 200 MG DAILY PO 2 YR 2 MG DAILY PO DAILY PO DAILY PO 2 2 YR YR Hyponatraemia Muscle Disorder Neuroleptic Malignant Syndrome Phlebitis Rhabdomyolysis Date:10/31/01ISR Number: 3818598-0Report Type:Expedited (15-DaCompany Report #A124605 Age:15 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 40.00 MG Hospitalization TOTAL; DAILY; Initial or Prolonged ORAL Required Intervention to ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Agitation Health Ziprasidone Po PS ORAL Neuroleptic Malignant Professional Lithium Carbonate Eskalith SS SS ORAL Vitamin B6 (Subject Drug) Paxil SS SS ORAL Renal Impairment Risperidone Clonidine (Subject Drug) Estradiol (Subject Drug) Ferrous Sequels 10:48 AM Route Syndrome ORAL 22-Aug-2005 Page: 378 Manufacturer C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Subject Drug) Trazodone (Subject Drug) C C Date:10/31/01ISR Number: 3818999-0Report Type:Expedited (15-DaCompany Report #NSADSS2001029546 Age:41 YR Gender:Male I/FU:F Outcome Dose Death ORAL PT Report Source Product Role Agitation Literature Haldol(Haloperidol) PS Blood Pressure Diastolic Decreased Blood Pressure Systolic Increased Clonic Convulsion Completed Suicide Drug Level Below Therapeutic Heart Rate Increased Mental Impairment Pyrexia Respiratory Rate Increased Tremor Ventricular Fibrillation Health Professional Lithium (Lithium) SS Date:10/31/01ISR Number: 3819777-9Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Manufacturer Route Duration ORAL Company Report #2001066135US PT Report Source Product Role Drug Interaction Movement Disorder Consumer Celebrex (Celecoxib) Capsule PS Lithium (Lithium) SS Manufacturer Route Duration 200 MG, QD, Muscle Twitching ORAL Date:11/01/01ISR Number: 3817985-4Report Type:Direct Age: Gender:Male I/FU:I Company Report # ORAL Outcome Dose Duration Hospitalization 300MG PO TID Initial or Prolonged PTA Required Intervention to Prevent Permanent Impairment/Damage PT Clonic Convulsion Report Source Product Role Lithium PS Hctz Sertraline Potassium Chloride Vit D L-Thyroxine Olanzapine Zonisamide Lorazepam Mirapex Nasocort C C C C C C C C C C Coordination Abnormal Drug Interaction Drug Level Above Therapeutic Hypernatraemia Multiple Sclerosis Nystagmus Psychotic Disorder Tremor Date:11/05/01ISR Number: 3820605-6Report Type:Expedited (15-DaCompany Report #17812-148 Age:57 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 379 10:48 AM PT Aspiration Asthenia Balance Disorder Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coma Coordination Abnormal Cough Dose Report Source Product Role Manufacturer Route Consumer Lithium Carbonate Capsules, 300 Mg Roxane Laboratories, Inc. PS ORAL Enalapril SS ORAL Duration Drooling Dysarthria Hypertonia Overdose 600 TO 900 Pneumonia MG, DAILY, Sepsis ORAL Temperature Intolerance ORAL Date:11/05/01ISR Number: 3820799-2Report Type:Expedited (15-DaCompany Report #02708 Age:44 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Intentional Misuse Literature Trazodone Lithium PS SS Manufacturer Route Manufacturer Route Manufacturer Route Duration Date:11/05/01ISR Number: 3820816-XReport Type:Expedited (15-DaCompany Report #02617 Age:80 YR Gender:Not SpecifiI/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Intentional Misuse Literature Temazepam Lithium PS SS Duration Date:11/06/01ISR Number: 3820983-8Report Type:Expedited (15-DaCompany Report #NSADSS2001031572 Age:63 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 200 MG , PT Report Source Product Role Confusional State Coordination Abnormal Drug Level Above Foreign Study Health Topiramate (Tablet (Bipolar)) (Topiramate) PS ORAL Therapeutic Professional DAILY, ORAL Drug Toxicity Lithium (Lithium) SS ORAL 900 MG, NIGHT Mania (S), ORAL Amantadine (Amatadine) Propanolol (Propranolol) Oxazepam (Oxazepam) C C C Date:11/07/01ISR Number: 3822555-8Report Type:Expedited (15-DaCompany Report #A125617 Age:26 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 1800.00 MG Hospitalization TOTAL; BID Initial or Prolonged 22-Aug-2005 Page: 380 10:48 AM PT Report Source Product Role Anxiety Literature Lithane Tablets PS Diarrhoea Health Dizziness Drug Toxicity Gait Disturbance Nausea Nystagmus Sedation Tremor Professional Herbal Diuretic Sertraline Propranolol Risperidone Lorezepam Hydroxizine Over-The-Counter Sinus Medication (Unspecified) SS C C C C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/01ISR Number: 3822762-4Report Type:Periodic Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 15 MILLIGRAM, Company Report #10760924 PT Report Source Product Role Manufacturer Route Drug Level Above Therapeutic Health Professional Buspar Tabs (Buspirone Hcl) PS ORAL Tremor Company Buspar Tabs (Buspirone Hcl) SS ORAL Lithium Carbonate SS Trazodone Hcl Effexor Xr Depakote C C C 3/1 DAY ORAL Representative 15 MILLIGRAM, 2/1 DAY ORAL 300MG, 1/1 DAY Date:11/07/01ISR Number: 3823503-7Report Type:Expedited (15-DaCompany Report #A125638 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 250.0 MG Initial or Prolonged TOTAL:DAILY:O PT Report Source Product Role Manufacturer Route Fall Foreign Zoloft Tablets PS ORAL Parkinson'S Disease Health Melperone SS ORAL Lithium Carbonate SS ORAL Professional RAL 25.00 MG TOTAL:DAILY: ORAL 900.00 MG TOTAL:DAILY:O RAL Oxazepam Chlormethiazole Ass (Acetylsalicylic Acid) Metoprolol Diltiazem Enalapril Date:11/09/01ISR Number: 3822982-9Report Type:Direct Age:40 YR Gender:Male I/FU:I Outcome Dose Other PT C C C C Company Report # Report Source Product Role Lithium PS Duration Aggression Date:11/12/01ISR Number: 3824384-8Report Type:Expedited (15-DaCompany Report #01P-062-0111690-00 Age:52 YR Gender:Female I/FU:F Outcome Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 381 C C 10:48 AM PT Blood Creatinine Increased Blood Osmolarity Increased Coma Diabetes Insipidus Drug Level Above Therapeutic Gait Disturbance Hypernatraemia Sedation Stupor Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Agent Toxicity Urinary Retention Dose Report Source Product Role Foreign Literature Health Professional Valproic Acid Iv (Depacon) (Valproate Sodium) (Valproate Sodium) PS Other Sodium Valproate /Valproic Acid SS Lithium SS Perazine Zotepine Lorazepam C C C Manufacturer Route Duration INTRAVENOUS PER ORAL INTRAVENOUS 2 ORAL DAY 1225 MG, 1 IN 1 D Date:11/13/01ISR Number: 3824653-1Report Type:Expedited (15-DaCompany Report #LBID00201004554 Age:13 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG BID PO Initial or Prolonged PT Report Source Product Role Abdominal Tenderness Literature Lithium Sr (Lithium) PS Blood Pressure Decreased Body Temperature Increased Differential White Blood Cell Count Abnormal Fall Haematuria Heart Rate Increased Influenza Leukocytosis Myocardial Infarction Respiratory Rate Increased Rhabdomyolysis Health Professional Olanzapine (Olanzapine) (Sertraline) SS C Manufacturer Route ORAL Date:11/13/01ISR Number: 3825644-7Report Type:Expedited (15-DaCompany Report #A125836 Age:56 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600.00 MG Initial or Prolonged TOTAL: BID: PT Report Source Product Role Agitation Literature Lithane Tablets PS Blood Parathyroid Hormone Health Increased Professional Fluphenazine Decanoate Aspirin Benztropine C C C ORAL Delirium Dizziness Dyspnoea Electrocardiogram Qt Shortened Electrocardiogram St Segment Abnormal Headache Hypercalcaemia Hypermagnesaemia Hypertension Hypophosphataemia Nausea Polyuria Tachycardia 22-Aug-2005 Page: 382 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/01ISR Number: 3829007-XReport Type:Expedited (15-DaCompany Report #2001025965-1 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1) 900 Initial or Prolonged MILLIGRAMS; Other 2) 675 PT Report Source Product Role Manufacturer Route Condition Aggravated Health Lithium PS Glaxosmithkline ORAL Drug Hypersensitivity Professional Acetylsalicylic Acid Metoprolol Succinate Diltiazem Hydrochloride Distraneurin (Clomethiazol) Eunerpan (Melperon Hydrochloride Oxazepam Xanef (Elanapril Maleate) Zoloft (Sertralin Hydrochloride) C C Route Gait Disturbance Restlessness MILLIGRAMS 3 MON C C C C C C Date:11/13/01ISR Number: 3829010-XReport Type:Expedited (15-DaCompany Report #2001025863-1 Age:77 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Delirium Hypernatraemia Nephrogenic Diabetes Insipidus Product Role Manufacturer Lithium Glaxosmithkline PS Glaxosmithkline Manufacturer Date:11/14/01ISR Number: 3825082-7Report Type:Expedited (15-DaCompany Report #2001UW14424 Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization - PT Report Source Product Role Balance Disorder Other Prilosec PS Route Initial or Prolonged Condition Aggravated Disorientation Fall Zyprexa Eskalith Wellbutrin SS SS SS Date:11/14/01ISR Number: 3825203-6Report Type:Expedited (15-DaCompany Report #1996008312-1 Age:47 YR Gender:Male I/FU:F Outcome Dose Duration Required Intervention to SEE IMAGE Prevent Permanent Impairment/Damage 450 PT Report Source Product Role Manufacturer Route Blood Pressure Increased Cold Sweat Consumer Parnate Smithkline Beecham PS Smithkline Beecham ORAL Eskalith-Cr (Lithium Carbonate) SS Dysarthria Fluid Retention Food Intolerance MILLIGRAMS Haemorrhage 2.0 DAILY Headache ORAL Hepatitis B Hypoaesthesia Vision Blurred 22-Aug-2005 Page: 383 10:48 AM Lithium Carbonate Prilosec (Omeprazole) Vistaril (Hydroxyzine Pamoate) Levsin (Hyoscyamine Sulfate) C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vancenase (Beclomethasone Dipropionate, Monohydrate) Serevent (Salmeterol Xinafoate) Aerobid (Flunisolide) Proventil (Albuterol Sulfate) Claritin (Loratadine) Niacin (Nicotinic Acid) Omega-3 Fatty Acids Tylenol #3 (Acetaminophen And Codeine Phosphate) Valisone (Betamethasone Valerate) Depakote (Divalproex Sodium) Atarax (Hydroxyzine) C C C C C C C C C C C Date:11/14/01ISR Number: 3826532-2Report Type:Expedited (15-DaCompany Report #2001025809-1 Age:68 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Food Poisoning Gastrointestinal Disorder Hiatus Hernia Hypernatraemia Nephrogenic Diabetes Insipidus Product Role Manufacturer Lithium Glaxosmithkline PS Glaxosmithkline Product Role Manufacturer Glucophage PS Bristol-Myers Squibb Route Date:11/16/01ISR Number: 3824883-9Report Type:Expedited (15-DaCompany Report #11530912 Age:76 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization - PT Drug Interaction Report Source Route Initial or Prolonged Therapeutic Agent Toxicity Company Lithium Nortriptyline Date:11/19/01ISR Number: 3827785-7Report Type:Expedited (15-DaCompany Report #FLUV00301003707 Age:54 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 384 10:48 AM PT C-Reactive Protein Increased Convulsion Dehydration Depressed Level Of Consciousness Diabetes Insipidus Electrolyte Imbalance Hypocalcaemia SS C ORAL ORAL ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Hypochloraemia Hypokalaemia Hyponatraemia Report Source Product Role Muscle Disorder Neuroleptic Malignant Syndrome Foreign Health Professional Depromel 50 (Fluvoxamine Maleate) PS ORAL Phlebitis Other Specific Gravity Urine Abnormal Rohypnol (Flunitrazepam) SS ORAL Thirst Contomin (Chlorpromazine Hydrochloride) SS ORAL Limas (Lithium Carbonate) SS ORAL Magnesium Oxide (Magnesium Oxide) C Manufacturer Route Duration 50 MG DAILY PO, 150 MG Pollakiuria DAILY PO, 200 Rhabdomyolysis MG DAILY PO 2 MG DAILY PO 25 MG DAILY PO 400 MG DAILY PO Date:11/21/01ISR Number: 3828529-5Report Type:Expedited (15-DaCompany Report #LBID00201003988 Age:45 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Benign Intracranial Hypertension Health Professional Lithium Carbonate (Lithium Carbonate) PS Cyst Company Delusion Dementia Duodenal Operation Hypothyroidism Representative Manufacturer Route Duration 300 MG Q4HR PO Tegretol (Carbamazepine) Flurazepam (Flurazepam) C C ORAL Nervous System Disorder Clonazepam (Clonazepam) Depakote (Valproate Semisodium) C C Date:11/21/01ISR Number: 3828641-0Report Type:Expedited (15-DaCompany Report #WAES 01111176 Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization PO Initial or Prolonged 675 MG/BID/PO 22-Aug-2005 Page: 385 10:48 AM PT Report Source Product Role Abdominal Tenderness Study Tab Vasotec Unk PS ORAL Blood Creatinine Health Eskalith 675 Mg SS ORAL Increased Blood Urea Increased Confusional State Diarrhoea Dizziness Drug Interaction Faecal Occult Blood Positive Haematocrit Decreased Haemoglobin Decreased Hypotension Movement Disorder Palpitations Vomiting Professional Elavil Tylenol Wellbutrin Sr Acetaminophen (+) Codeine Estrogens (Unspecified) Felodipine Medroxyprogesterone Acetate Omeprazole Ranitidine Hydrochloride Terazosin Hydrochloride C C C C C C C C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/01ISR Number: 3830063-3Report Type:Expedited (15-DaCompany Report #11530912 Age:76 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1000 PT Report Source Product Role Acidosis Bradycardia Health Professional Glucophage (Metformin Hcl) PS ORAL Drug Interaction Company Drug Toxicity Representative Lithium (Lithium Salts) SS ORAL Nortriptyline C Manufacturer Route MILLIGRAM, 2/1 DAY ORAL Speech Disorder 300 MILLIGRAM, 2/1 DAY ORAL Date:11/27/01ISR Number: 3830709-XReport Type:Expedited (15-DaCompany Report #A125617 Age:26 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening 1800.00 MG Hospitalization TOTAL:BID Initial or Prolonged PT Report Source Product Role Anxiety Literature Lithane Tablets PS Diarrhoea Health Dizziness Drug Level Above Therapeutic Drug Toxicity Gait Disturbance Nausea Nystagmus Sedation Tremor Professional Herbal Diuretic Sertraline Propranolol Risperidone Lorezepam Hydroxizine Over-The-Counter Sinus Medication (Unspecified) SS C C C C C Date:11/28/01ISR Number: 3831393-1Report Type:Expedited (15-DaCompany Report #LBID00201004755 Age:56 YR Gender:Female I/FU:I C Manufacturer Route Outcome Dose Duration Hospitalization Initial or Prolonged DAILY PO, 900 PT Report Source Product Role Manufacturer Route Atrioventricular Block Complete Health Professional Lithobid (Lithium Carbonate) PS ORAL Sick Sinus Syndrome Company Lamictal (Lamotrigine) SS ORAL MG PO Representative 25 MG QD PO, 25 MG BID PO, 250 MG PO Date:11/29/01ISR Number: 3832502-0Report Type:Direct Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 386 10:48 AM PT Anorexia Blood Pressure Increased Body Temperature Increased Cognitive Disorder Drug Level Above Therapeutic Heart Rate Increased Mental Impairment Nausea Tremor Company Report # Report Source Product Role Lithium PS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/01ISR Number: 3834464-9Report Type:Expedited (15-DaCompany Report #2001027385-1 Age:83 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 400 Initial or Prolonged MILLIGRAMS PT Report Source Product Role Manufacturer Biopsy Kidney Abnormal Literature Lithium PS Glaxosmithkline Inguinal Hernia Health Nephrotic Syndrome Professional Deflazacort Enalapril Gliclazide Levomepromazine Lorazepam Paroxetine Prednisone C C C C C C C Route Date:12/04/01ISR Number: 3834701-0Report Type:Expedited (15-DaCompany Report #APCDSS2001001339 Age:93 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Depressed Level Of Consciousness Drug Interaction Foreign Health Professional Risperdal (Unspecified) (Risperidone) PS ORAL Dysphagia Company Lithium (Lithium) SS ORAL Hyperreflexia Lethargy Muscle Rigidity Muscle Twitching Musculoskeletal Stiffness Neuroleptic Malignant Syndrome Urinary Tract Infection Representative Route SEE IMAGE SEE IMAGE Date:12/11/01ISR Number: 3839114-3Report Type:Expedited (15-DaCompany Report #LBID00201005043 Age:31 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization DAILY Initial or Prolonged Chest Pain Foreign Lithium (Lithium) PS Clonic Convulsion Difficulty In Walking Literature Other Fluvoxamine (Fluvoxamine) SS 150 MG DAILY, Disturbance In Attention 200 MG DAILY Drug Interaction Fatigue Hyperreflexia Lethargy Nausea Pyrexia Sensory Loss Serotonin Syndrome Urinary Tract Infection Vomiting Triazolam (Triazolam) Nitrazepam (Nitrazepam) Date:12/12/01ISR Number: 3840014-3Report Type:Expedited (15-DaCompany Report #HQ9037403DEC2001 Age:77 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 387 10:48 AM PT Confusional State Drug Interaction Therapeutic Agent Toxicity Tremor C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Dose Report Source Product Role Health Professional Effexor Xr (Venlafaxine Hydrochloride, Capsule, Extended Release) PS Manufacturer Route Duration ORAL 300 MG 1X PER 1 DAY, ORAL Lithium (Lithium, ) Toradol (Ketorolac Tromethamine, ) Unspecified Non-Steroidal Anti-Inflammatory Agent(Unspecified) SS SS SS Date:12/12/01ISR Number: 3840058-1Report Type:Expedited (15-DaCompany Report #2001-UK-02032UK(0) Age:69 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 40 MG (40 MG DAILY) 2 PT Report Source Product Role Manufacturer Route Difficulty In Walking Drug Level Increased Foreign Health Micardis (Bibr 277) (Nr) (Telmisartan) PS ORAL Fall Professional Lithium Carbonate (Lithium Carbonate (Nr) SS ORAL MON Other 400 MG (400 MG DAILY) Clopixol (Clopenthixol Decanoate) (Nr) Co-Amilofruse (Frumil) (Nr) Procyclidine (Procyclidine) (Nr) Glimepiride (Nr) C C C C Date:12/13/01ISR Number: 3838288-8Report Type:Expedited (15-DaCompany Report #303320 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Suicidal Ideation Report Source Product Role Manufacturer Xenical Lithium Efexor PS SS SS Roche Date:12/13/01ISR Number: 3840331-7Report Type:Expedited (15-DaCompany Report #EMADSS2001005486 Age:48 YR Gender:Female I/FU:F Outcome Life-Threatening 22-Aug-2005 Page: 388 10:48 AM PT Blood Creatine Phosphokinase Increased Body Temperature Increased Catatonia Dysphagia Headache Muscle Rigidity Neuroleptic Malignant Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Respiratory Failure Speech Disorder Dose Report Source Product Role Foreign Study Health Risperidone (Unspecified) (Risperidone) PS Topiramate (Capsule) (Topiramate) SS ORAL Placebo (Placebo) SS ORAL Lithium (Lithium) SS ORAL Manufacturer Route Duration PATIENT HAD Professional PREVIOUSLY RECEIVED RISPERIDONE FROM 3 CAP, DAILY, ORAL 3 CAP, DAILY, ORAL 3 CAP, DAILY, ORAL Lorazepam (Lorazepam) Chloral Hydrate (Chloral Hydrate) Diazepam (Diazepam) Olanzapine (Olanzapine) Senna (Senna) Lactulose (Lactulose) Haloperidol (Haloperidol) Lithium Carbonate (Lithium Carbonate) C C C C C C C C Date:12/17/01ISR Number: 3840327-5Report Type:Expedited (15-DaCompany Report #303320 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Suicidal Ideation Foreign Health Professional Xenical (Orlistat) Lithium (Lithium Nos) Efexor (Venlafaxine Hydrochloride) PS Date:12/17/01ISR Number: 3841709-8Report Type:Direct Age:56 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 1 QAM 2Q HRS Initial or Prolonged (DON'T KNOW PT Dehydration Manufacturer Route SS Company Report # Report Source Product Role Lithium PS Thiothixene Depakote Amoxicillin Zoloft C C C C Drug Toxicity Mental Impairment 10:48 AM Route SS STRENGTH) 22-Aug-2005 Page: 389 Manufacturer FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/01ISR Number: 3841098-9Report Type:Expedited (15-DaCompany Report #FLUV00301004962 Age:31 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Asthenia Chest Pain Clonic Convulsion Foreign Literature Health Depromel 50 (Fluvoxamine Maleate) PS ORAL Csf Protein Increased Professional Depressed Level Of Consciousness Other Limas (Lithium Carbonate) SS ORAL Halcion (Triazolam) SS ORAL Benzalin (Nitrazepam) SS ORAL 150 MG DAILY PO 400 MG DAILY Difficulty In Walking PO Disorientation 0.25 MG DAILY Hyperreflexia PO Lethargy Medication Error 10 MG DAILY Memory Impairment PO Nausea Pyrexia Sensory Disturbance Serotonin Syndrome Urinary Tract Infection Vomiting White Blood Cell Count Increased Date:12/18/01ISR Number: 3841100-4Report Type:Expedited (15-DaCompany Report #LBID00201005043 Age:31 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 400 MG DAILY PT Report Source Product Role Asthenia Chest Pain Foreign Literature Limas (Lithium Carbonate) PS Clonic Convulsion Health Csf Protein Increased Professional PO Fluvoxamine Manufacturer Route ORAL Depressed Level Of Other (Fluvoxamine) SS Halcion (Triazolam) SS ORAL Benzalin (Nitrazepam) SS ORAL 150 MG DAILY Consciousness 0.25 MG DAILY Difficulty In Walking PO Disorientation Hyperreflexia 10 MG DAILY Lethargy PO Medication Error Memory Impairment Nausea Pyrexia Sensory Disturbance Serotonin Syndrome Urinary Tract Infection Vomiting White Blood Cell Count Increased Date:12/18/01ISR Number: 3841824-9Report Type:Expedited (15-DaCompany Report #2001-BP-04987RO (0) Age:66 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Cerebrovascular Accident Fatigue Therapeutic Agent Consumer Lithium Carbonate Capsules (Lithium Carbonate) PS Zyprexa (Olanzapine) Aspirin C C PO/"ABOUT 2 Toxicity YEARS" 22-Aug-2005 Page: 390 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Advair (Fluticasone/Salmetr ol) Ativan(Lorazepam) Celexa (Citalopram) Spironolactone (Spironolactone) Sonata (Zaleplon) Vioxx (Rofecoxib) Vitamin C(Ascorbic Acid) Vitamin D (Ergocalciferol) C C C C C C C C Date:12/18/01ISR Number: 3841832-8Report Type:Expedited (15-DaCompany Report #2001-BP-05079RO (0) Age:1 DY Gender:Female I/FU:I Outcome Dose Duration Congenital Anomaly INTRA-UTERINE PT Report Source Product Role Congenital Anomaly Craniosynostosis Drug Level Above Consumer Lithium Carbonate Capsules (Lithium Carbonate) PS Vitamins (Vitamins) C Manufacturer Route Manufacturer Route IU Therapeutic Maternal Drugs Affecting Foetus Spine Malformation Date:12/19/01ISR Number: 3842299-6Report Type:Expedited (15-DaCompany Report #A129287 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Anxiety Obsessive-Compulsive Disorder Renal Disorder Suicidal Ideation Weight Decreased Consumer Lithane Tablets PS Date:12/19/01ISR Number: 3842307-2Report Type:Expedited (15-DaCompany Report #A126997 Age:39 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 120.00 MG Initial or Prolonged TOTAL: DAILY: Required ORAL Intervention to 300.00 MG Prevent Permanent TOTAL: DAILY: Impairment/Damage ORAL 22-Aug-2005 Page: 391 10:48 AM PT Report Source Product Role Manufacturer Route Convulsion Health Ziprasidone Po PS ORAL Drug Interaction Professional Desipramine SS ORAL Lithobid Lorazepam Synthroid (Levothyroxine) Wellbutrin (Bupropion) Loestrin Chinese Herbs SS C Drug Level Above Therapeutic Epilepsy Medication Error C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/01ISR Number: 3842564-2Report Type:Expedited (15-DaCompany Report #NSADSS2001031572 Age:63 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Condition Aggravated Confusional State Coordination Abnormal Foreign Study Health Topiramate (Tablet (Bipolar ) (Topiramate) PS ORAL Drug Level Increased Professional Lithium (Lithium) SS ORAL 200 MG DAILY, ORAL Mania 900 MG, NIGHT (S), ORAL Amantadine (Amantadine) Propanolol (Propanolol) Oxazepam (0xazepam) C C C Date:12/19/01ISR Number: 3842681-7Report Type:Expedited (15-DaCompany Report #2001028574-1 Age:56 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 909 Initial or Prolonged MILLIGRAMS Other 2.0 DAILY 30 YR PT Report Source Product Role Accidental Overdose Health Lithium PS Confusional State Professional Manufacturer Route Manufacturer Route Dehydration Drug Level Above Therapeutic Drug Toxicity Date:12/20/01ISR Number: 3843291-8Report Type:Direct Age:24 YR Gender:Male I/FU:I Outcome PT Dose Duration Other Hallucination, Auditory INTRAMUSCULAR 75MG IM Company Report # Report Source Product Role Haldol Decanoate PS Suicidal Ideation Lithium Carbonate SS ORAL 600-600-300MG PO (SEE IMAGE) Date:12/24/01ISR Number: 3843957-XReport Type:Expedited (15-DaCompany Report #LBID00201004755 Age:56 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG DAILY PT Report Source Product Role Manufacturer Route Atrioventricular Block Complete Health Professional Lithobid (Lithium Carbonate) PS ORAL Sick Sinus Syndrome Company Lamictal (Lamotrigine) SS ORAL PO Representative SEE IMAGE 2 WK Folic Acid (Folic Acid) Synthroid (Levothyroxine Sodium) Prozac (Fluoxetine Hydrochloride) Trazodone (Trazodone) Concerta (Methylphenidate Slow Release) 22-Aug-2005 Page: 392 10:48 AM C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/24/01ISR Number: 3843965-9Report Type:Expedited (15-DaCompany Report #LBID00201005124 Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PO PT Report Source Product Role Drug Level Below Therapeutic Health Professional Lithobid (Lithium Carbonate) PS Drug Toxicity Dry Skin Haemorrhage Subcutaneous Trazodone (Trazodone) Nortriptyline (Nortriptyline) Nexium (Omeprazole) Trileptal (Oxcarbazepine) Norvasc (Amlodipine Besilate) Hyzaar Manufacturer Route ORAL C C C C C C Date:12/24/01ISR Number: 3844430-5Report Type:Expedited (15-DaCompany Report #LBID00201005103 Age:10 MON Gender:Female I/FU:I Outcome Dose Duration Congenital Anomaly PT Report Source Product Role Complications Of Maternal Exposure To Therapeutic Consumer Lithobid (Lithium Carbonate) PS Manufacturer Route Manufacturer Route DAILY PL Drugs Maternal Drugs Affecting Foetus Pregnancy Skull Malformation Spine Malformation Date:12/26/01ISR Number: 3844970-9Report Type:Expedited (15-DaCompany Report #A125638 Age:51 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 250.00 MG Initial or Prolonged TOTAL:DAILY:O PT Report Source Product Role Demyelination Foreign Zoloft Tablets PS Fall Health ORAL Gait Disturbance Professional RAL Parkinson'S Disease Melperone SS ORAL Lithium Carbonate SS ORAL Oxazepam Chlormethiazole Ass (Acetylsalicylic Acid) Metoprolol Diltiazem Enalapril C C 25.00 MG Restlessness TOTAL:DAILY:O RAL 900.00 MG TOTAL:DAILY:O RAL Date:12/26/01ISR Number: 3844982-5Report Type:Expedited (15-DaCompany Report #A129265 Age:41 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged Required Intervention to 22-Aug-2005 Page: 393 10:48 AM C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage Dose PT Report Source Product Role Aggression Cushingoid Leukocytosis Paranoia Psychiatric Symptom Literature Health Professional Lithane Tablets Clozapine Thioridiazine PS SS C Manufacturer Route Manufacturer Route Duration Date:12/26/01ISR Number: 3845293-4Report Type:Expedited (15-DaCompany Report #FLUV00301004962 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Chest Pain Difficulty In Walking Fatigue Foreign Literature Health Depromel 50 (Fluvoxamine Maleate) PS ORAL Lethargy Professional Pyrexia Sensory Disturbance Other Limas (Lithium Carbonate) SS ORAL 150MG DAILY PO 400 MG DAILY Serotonin Syndrome PO; 400 MG Urinary Retention DAILY PO Urinary Tract Infection Vomiting Pollakisu (Oxybutynin Hydrochloride) Halcion (Triazolam) Benzalin (Nitrazepam) Date:12/27/01ISR Number: 3864071-3Report Type:Periodic Age:70 YR Gender:Female I/FU:F Outcome Dose 12.5 C C C Company Report #WAES 01082050 PT Report Source Product Role Epigastric Discomfort Consumer Tab Vioxx 12.5 Mg PS Manufacturer Route Duration ORAL Tremor MG/DAILY/PO Eskalith SS Sinemet Tums Ultram C C C ORAL 12.5 MG/DAILY/PO Date:12/31/01ISR Number: 3845964-XReport Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 900MG/D PO Initial or Prolonged 2MG BID PO PT 22-Aug-2005 Page: 394 10:48 AM Report Source Product Role Decreased Activity Lithium (300mg) PS ORAL Drug Toxicity Risperidone (2mg) SS ORAL Dysarthria Swelling Toxicologic Test Abnormal Propoxyphene C Date:12/31/01ISR Number: 3846020-7Report Type:Direct Age:81 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged Company Report #CTU 157967 PT Diarrhoea Drug Toxicity Gait Disturbance Company Report #CTU 158056 Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Medication Error Renal Failure Acute Tremor Dose Report Source Product Role Health Professional Lithium Carbonate 300mg PS Manufacturer Route Duration ORAL 300MG BID ORAL Date:12/31/01ISR Number: 3847105-1Report Type:Expedited (15-DaCompany Report #A124605 Age:15 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening 40.00 MG Hospitalization TOTAL:DAILY:O Initial or Prolonged RAL Disability 300.00 MG Required TOTAL:DAILY:O Intervention to RAL Prevent Permanent Impairment/Damage 450.00 MG PT Report Source Product Role Manufacturer Route Acute Prerenal Failure Health Ziprasidone Po PS ORAL Agitation Professional Lithium Carbonate SS ORAL Eskalith (Lithium Carbonate) SS ORAL Paxil (Paroxetine) SS ORAL Clonidine Estradiol Trazodone Vitamin B6 Ferrous C C C C Anxiety Blood Creatine Phosphokinase Increased Cognitive Disorder Depressed Level Of Consciousness Disorientation TOTAL:DAILY:O Dysarthria RAL Dyskinesia 25.00 MG Dysphagia TOTAL:DAILY:O Hallucination RAL Hostility Incoherent Irritability Motor Dysfunction Muscle Twitching Musculoskeletal Stiffness Neuroleptic Malignant Syndrome Oliguria Screaming Tearfulness Tic White Blood Cell Count Increased Fumarate/Docusate Risperidone C C Date:01/02/02ISR Number: 3847444-4Report Type:Expedited (15-DaCompany Report #2001025965-1 Age:51 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Other 900 PT Report Source Product Role Manufacturer Route Areflexia Chills Fall Health Professional Quilonum Retard (Lithium) Glaxosmithkline PS Glaxosmithkline ORAL Gait Disturbance MILLIGRAMS Parkinsonism ORAL 3 MON Restlessness 22-Aug-2005 Page: 395 10:48 AM Ass (Acetylsalicylic Acid) Beloc Zok (Metoprolol Succinate) Dilzem (Diltiazem Hydrochloride) Distraneurin (Clomethiazol) Eunerpan (Melperon Hydrochloride) C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxazepam Xanef (Elanapril Maleate) Zoloft (Sertralin Hydrochloride) C C C Date:01/02/02ISR Number: 3847669-8Report Type:Expedited (15-DaCompany Report #2001029998-1 Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 800 PT Report Source Dizziness Dry Mouth Product Role Manufacturer Route Lithium Glaxosmithkline PS Glaxosmithkline ORAL Citalopram (Cipramil) Diclofenac Dihydrocodeine Oxybutynin C C C C Fatigue MILLIGRAMS Memory Impairment ORAL Date:01/02/02ISR Number: 3847672-8Report Type:Expedited (15-DaCompany Report #2001030000-1 Age:86 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 800 Disability MILLIGRAMS PT Confusional State Diabetes Insipidus Report Source Product Role Manufacturer Route Lithium Glaxosmithkline PS Glaxosmithkline ORAL Frusemide Haloperidol Thyroxine C C C Drug Level Increased Hypernatraemia ORAL Date:01/04/02ISR Number: 3847814-4Report Type:Expedited (15-DaCompany Report #304132 Age:40 YR Gender:Male I/FU:I Outcome Dose Disability 3 DAY 2 DAY 2 DAY PT Report Source Product Role Manufacturer Large Intestinal Ulcer Health Tamiflu PS Roche Professional Lexotan Limas Cefzon SS SS SS Roche Loxonin SS Route Duration Date:01/04/02ISR Number: 3848250-7Report Type:Periodic Age:32 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report #01-05-0261 PT Report Source Product Role Manufacturer Route Grand Mal Convulsion Health Professional Clozapine - Ivax Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL 700 MG QD ORAL Lithium Tablets SS Navane C 900 MG QD ORAL 22-Aug-2005 Page: 396 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/02ISR Number: 3849058-9Report Type:Direct Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900MG QD PT Company Report #CTU 158487 Report Source Abnormal Behaviour Delirium Product Role Lithium Carbonate(300mg) PS Manufacturer Route Manufacturer Route Manufacturer Route Manufacturer Route Drug Toxicity Date:01/07/02ISR Number: 3849070-XReport Type:Direct Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1800MG QD Initial or Prolonged PT Company Report #CTU 158481 Report Source Coordination Abnormal Lithium (300mg) PS Company Report #CTU 158477 PT Report Source Product Role Confusional State Health Lithium Carbonate PS Dehydration Hypernatraemia Nausea Vomiting Professional Date:01/07/02ISR Number: 3849157-1Report Type:Direct Age:44 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600MG BID Initial or Prolonged Role Diarrhoea Fall Tremor Date:01/07/02ISR Number: 3849155-8Report Type:Direct Age:77 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG BID Initial or Prolonged Product PT Company Report #CTU 158418 Report Source Product Role Drug Toxicity Lithium (300mg) PS Tremor Ibuprofen C Fluoxetine C Date:01/08/02ISR Number: 3849931-1Report Type:Expedited (15-DaCompany Report #304132 Age:40 YR Gender:Male I/FU:I Outcome Dose Disability PT Report Source Product Role Manufacturer Route Large Intestinal Ulcer Foreign Health Tamiflu (Oseltamivir) PS ORAL Lexotan (Bromazepam) SS ORAL Limas (Lithium Carbonate) SS ORAL Cefzon (Cefdinir) SS ORAL Loxonin (Loxoprofen) SS ORAL Duration 150 MG DAILY; Professional ORAL 2 MG DAILY; ORAL 400 MG DAILY; ORAL 300 MG DAILY; ORAL 180 MG DAILY; ORAL 22-Aug-2005 Page: 397 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/02ISR Number: 3850557-4Report Type:Direct Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Company Report #CTU 158695 Report Source Mental Status Changes Neck Pain Product Role Lithium 900mg PS Manufacturer Route Route Date:01/08/02ISR Number: 3850882-7Report Type:Expedited (15-DaCompany Report #2001030025-1 Age:68 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 600 Initial or Prolonged MILLIGRAMS PT Report Source Product Role Manufacturer Blood Creatinine Increased Literature Health Lithium Glaxosmithkline PS Glaxosmithkline Blood Sodium Increased Professional Manufacturer Blood Urea Increased Deep Vein Thrombosis Faecaloma Nephrogenic Diabetes Insipidus Tongue Coated Urine Osmolarity Decreased Date:01/10/02ISR Number: 3851473-4Report Type:Expedited (15-DaCompany Report #LBID00202000039 Age:45 YR Gender:Male I/FU:I Outcome Dose Other 300 MG BID PT Report Source Product Role Anxiety Literature Lithium (Lithium) PS Confusional State Health Convulsion Professional PO, 900 MG DAILY PO, Depression 1200 MG DAILY Insomnia PO Route Duration 1 DAY Somnolence Venlafaxine ORAL (Venlafaxine) SS ORAL Bupropion (Bupropion) SS ORAL 150 MG BID PO 100 MG BID PO, 300 MG DAILY PO, 200 MG DAILY PO Gabapentin (Gabapentin) Clonazepam (Clonazepam) Glycopyrrolate (Glycophyrrolate) Methotexital (Methohexital) Succinylcholine (Succinylcholine Chloride) Oxygen (Oxygen) Date:01/14/02ISR Number: 3852023-9Report Type:Direct Age:54 YR Gender:Male I/FU:I Outcome Dose Other 22-Aug-2005 Page: 398 PT C C C C C C Company Report #CTU 159017 Report Source Product Role Lithium PS Duration Agitation Delirium 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/02ISR Number: 3852038-0Report Type:Direct Age:70 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Arrhythmia Dehydration Diabetes Mellitus Drug Toxicity Pharmaceutical Product Complaint Renal Failure Acute Date:01/16/02ISR Number: 3853273-8Report Type:Direct Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG TID Initial or Prolonged Company Report #CTU 159050 PT Outcome PT Dose Duration Other Blood Prolactin Increased INTRAMUSCULAR 75 MG IM Hallucination, Auditory 600-600-300 Homicidal Ideation MG PO Suicidal Ideation Role Sulindac Lithium PS SS Manufacturer Route Manufacturer Route Manufacturer Route Company Report #CTU 159359 Report Source Mental Status Changes Date:01/16/02ISR Number: 3853379-3Report Type:Direct Age:24 YR Gender:Male I/FU:I Product Product Role Lithium PS Temazepam Risperidone Terazosin Hctz C C C C Company Report #CTU 159324 Report Source Product Role Haldol Decanoate PS Lithium Carbonate SS Haldol Decanoate C Date:01/17/02ISR Number: 3855102-5Report Type:Expedited (15-DaCompany Report #WAES 0201FRA00016 Age:85 YR Gender:Male I/FU:I ORAL Outcome Dose Duration Hospitalization Initial or Prolonged 20.12.5 PT Report Source Product Role Manufacturer Route Confusional State Drug Interaction Foreign Health Vaseretic (Enalapril Maleate-Hctz) PS ORAL Drug Level Above Professional Therapeutic Other Lithiumco3 SS ORAL MG/DAILY, PO 625 MG/DAILY, Haemodialysis PO Tremor Urinary Retention Date:01/17/02ISR Number: 3855724-1Report Type:Direct Age:59 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600 MG BID Initial or Prolonged ORAL PT Cognitive Disorder Confusional State Coordination Abnormal Disorientation Drug Toxicity Memory Impairment Tremor 22-Aug-2005 Page: 399 10:48 AM Company Report #CTU 159578 Report Source Product Role Lithium PS Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/18/02ISR Number: 3854117-0Report Type:Expedited (15-DaCompany Report #A0171401A Age:56 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Atrioventricular Block 250MG Per day MON Initial or Prolonged Complete 900MG Per day MON Sick Sinus Syndrome Date:01/22/02ISR Number: 3856677-2Report Type:Direct Age:78 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 30MG BID PT Report Source Product Role Manufacturer Route Lamictal PS Glaxo Wellcome ORAL Lithobid SS Glaxo Wellcome ORAL Product Role Manufacturer Route Lithium Carbonate 300 Mg PS Company Report #CTU 159681 Report Source Asthenia Bradycardia ORAL Decreased Appetite ORAL Drug Level Above Therapeutic Drug Toxicity Dysarthria Fatigue Polydipsia Polyuria Tremor Vomiting Date:01/23/02ISR Number: 3859351-1Report Type:Expedited (15-DaCompany Report #2002000438-1 Age:59 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Compulsions Disorientation Disturbance In Attention Electroencephalogram Abnormal Encephalopathy Faecal Incontinence Literature Health Professional Lithium Glaxosmithkline Haloperidol Carbamazapine Olnazapine PS C C C Glaxosmithkline Route Memory Impairment Obsessive Thoughts Thinking Abnormal Date:01/23/02ISR Number: 3859638-2Report Type:Direct Age:56 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 450 MG BID Hospitalization ORAL Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Company Report #CTU 159954 Report Source Dialysis 22-Aug-2005 Page: 400 10:48 AM Lithium Role 450 Mg Drug Effect Decreased Therapeutic Agent Toxicity Date:01/23/02ISR Number: 3859796-XReport Type:Periodic Age:78 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Product PT Asthenia Confusional State Company Report #NSADSS2001003095 PS Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disturbance In Attention Extrapyramidal Disorder Infection Dose Report Source Product Role Manufacturer Route Health Professional Risperdal (Tablet) (Risperidone) PS ORAL Eskalith (Lithium Carbonate) SS ORAL Duration Mania 0.5 MG, 1 IN Company 1 DAY(S), Representative ORAL : 1.5 MG DAILY ORAL 450 MG, 2 IN 1 DAY(S), ORAL Neurontin (Gabapentin) Paxil (Paroxetine Hydrochloride) Premarin (Estrogens Conjugated) Detrol (Tolterodine L-Tartrate) Lorazepam (Lorazepam) C C C C C Date:01/23/02ISR Number: 3860152-9Report Type:Expedited (15-DaCompany Report #A200759 Age:31 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 400.00 MG Initial or Prolonged TOTAL:DAILY:O PT Report Source Product Role Asthenia Foreign Lithane Tablets PS Chest Pain Health Csf Protein Increased Professional Fluvoxamine SS RAL Difficulty In Walking 150.00 MG Manufacturer Route ORAL Fatigue TOTAL:DAILY Insomnia Triazolam SS ORAL Nitrazepam SS ORAL 0.25 MG Lethargy TOTAL:DAILY:O Medication Error RAL Pyrexia 10.00 MG Sensory Disturbance TOTAL:DAILY:O Serotonin Syndrome RAL Urinary Tract Infection Vomiting White Blood Cell Count Increased Date:01/23/02ISR Number: 3860474-1Report Type:Direct Age:47 YR Gender:Female I/FU:I Outcome Dose PT Company Report #CTU 160150 Report Source Product Role Manufacturer Route Lithium Carbonate 300mg Roxane Labs PS Roxane Labs ORAL Duration Medication Error 300MG 2 X DAY ORAL Date:01/24/02ISR Number: 3858316-3Report Type:Expedited (15-DaCompany Report #2002000441-1 Age:45 YR Gender:Male I/FU:I Outcome Other 22-Aug-2005 Page: 401 PT Anxiety Confusional State Convulsion 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Somnolence Dose Report Source Product Role Manufacturer Route Literature Health Lithium Glaxosmithkline PS Glaxosmithkline ORAL Bupropion Venlafaxine Gabapentin Clonazepam Glycopyrrolate Methohexital Succinylcholine C C C C C C C Role Manufacturer Route PS Glaxosmithkline Duration 300 Professional MILLIGRAMS 2.0 DAILY ORAL ; ORAL ; ORAL 3 DAY Date:01/24/02ISR Number: 3860064-0Report Type:Expedited (15-DaCompany Report #2002000437-1 Age:55 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Duration Clonic Convulsion Pyrexia Lithium Glaxosmithkline Clozapril (Clozapine) C Date:01/24/02ISR Number: 3860176-1Report Type:Expedited (15-DaCompany Report #2002000756-1 Age:52 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1225 MILLIGRAM PT Report Source Product Role Manufacturer Bipolar Disorder Blood Creatine Increased Literature Health Lithium Glaxosmithkline PS Glaxosmithkline Blood Creatinine Professional Route Increased Blood Osmolarity Increased Coma Consciousness Fluctuating Drug Ineffective Drug Toxicity Hypernatraemia Mania Movement Disorder Nephrogenic Diabetes Insipidus Somnolence Carbamazepine Lorazepam Perazine Valproate Zotepine C C C C C Date:01/25/02ISR Number: 3857889-4Report Type:Expedited (15-DaCompany Report #304132 Age:40 YR Gender:Male I/FU:F Outcome Dose Disability 3 DAY 917 DAY 917 DAY 2 DAY 2 DAY 22-Aug-2005 Page: 402 PT Report Source Product Role Manufacturer Tamiflu PS Roche Lexotan SS Roche Limas SS Cefzon SS Loxonin SS Duration Peritonitis 10:48 AM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/28/02ISR Number: 3858992-5Report Type:Expedited (15-DaCompany Report #A0171401A Age:56 YR Gender:Female I/FU:F Outcome PT Dose Duration Hospitalization Atrioventricular Block 350MG Per day MON Initial or Prolonged Complete 900MG Per day YR Chest Pain Dizziness Drug Interaction Dyspnoea Fatigue Heart Rate Decreased Nausea Sensation Of Heaviness Sick Sinus Syndrome Report Source Product Role Manufacturer Route Lamictal PS Glaxo Wellcome ORAL Lithobid SS Glaxo Wellcome ORAL Folic Acid Synthroid Prozac Trazodone Concerta Nsaid C C C C C C Glaxo Wellcome Date:01/28/02ISR Number: 3861159-8Report Type:Expedited (15-DaCompany Report #EMADSS2001005486 Age:48 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Blood Creatine Phosphokinase Increased Body Temperature Foreign Study Health Risperidone (Unspecified) (Risperidone) PS Increased Professional Topiramate (Capsule) (Topiramate) SS ORAL Placebo (Placebo) SS ORAL PATIENT HAD PREVIOUSLY Catatonia RECEIVED Dysphagia RISPERIDONE Headache FROM Muscle Rigidity Neuroleptic Malignant 3 CAP DAILY, Syndrome ORAL Respiratory Failure 3 CAP, DAILY, Speech Disorder ORAL Lithium (Lithium) Lorazepam (Lorazepam) Chloral Hydrate (Chloral Hydrate) Diazepam (Diazepam) Olanzapine (Olanzapine) Senna (Senna) Lactulose (Lactulose) Haloperidol (Haloperidol) Lithium Carbonate (Lithium Carbonate) SS C C C C C C C C Date:01/28/02ISR Number: 3862202-2Report Type:Expedited (15-DaCompany Report #A0172394A Age:45 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Anxiety Confusional State Convulsion Literature Health Professional Wellbutrin Tablet (Bupropion Hydrochloride) PS ORAL Depression Drug Ineffective Insomnia Somnolence 22-Aug-2005 Page: 403 Manufacturer Route Duration 10:48 AM Lithium Salt (Lithium Salt) Venlafaxine Hydrochloride (Venalfaxine SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS Electroconvulsive Therapy (Electroconvulsive Therapy) SS 150 MG/TWICE PER DAY SEE DOSAGE TEXT Gabapentin Clonazepam Glycopyrronium Bromide Methohexitone Suxamethonium Oxygen Citalopram C C C C C C C Date:01/29/02ISR Number: 3861835-7Report Type:Expedited (15-DaCompany Report #304132 Age:40 YR Gender:Male I/FU:F Outcome Dose Disability PT Report Source Product Role Abdominal Pain Upper Diarrhoea Foreign Health Tamiflu (Oseltamivir) 75 Mg PS ORAL Influenza Professional Lexotan (Bromazepam) SS ORAL Limas (Lithium Carbonate) SS ORAL Cefzon (Cefdinir) SS ORAL Loxonin (Loxoprofen) 60 Mg SS ORAL Manufacturer Route Duration 75 MG 2 PER 1 DAY; ORAL Laboratory Test Abnormal 1 MG 2 PER 1 Large Intestinal Ulcer DAY; ORAL Peritonitis Shock 200 MG 2 PER White Blood Cell Count 1 DAY; ORAL Abnormal 100 MG 3 PER 1 DAY; ORAL 60 MG 3 PER 1 DAY; ORAL Date:02/01/02ISR Number: 3864566-2Report Type:Expedited (15-DaCompany Report #FLUV00301004962 Age: Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 404 10:48 AM PT Angina Pectoris Asthenia Blood Lactate Dehydrogenase Decreased Blood Urea Decreased Blood Urine Present Csf Protein Increased Depression Difficulty In Walking Drug Interaction Drug Level Decreased Dysuria Electroencephalogram Abnormal Fatigue Headache Insomnia Lethargy Medication Error Overdose Sensory Disturbance Serotonin Syndrome FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Tract Infection Vomiting Dose Report Source Product Role Manufacturer Route Foreign Literature Health Depromel 50 (Fluvoxamine Maleate) PS ORAL Limas (Lithium Carbonate) SS ORAL Duration 150 MG DAILY Professional PO Other 400 MG DAILY PO, 400 MG DAILY PO Pollakisu (Oxybutynin Hydrochloride) Halcion (Triazolam) Benzalin (Nitrazepam) Date:02/04/02ISR Number: 3863835-XReport Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG PO BID 5 WK Initial or Prolonged PT C C C Company Report #CTU 160716 Report Source Product Role Difficulty In Walking Lithium Carbonate PS Hypotension Malaise Triamterene/Hctz Lisinopril C C Manufacturer Route ORAL Date:02/05/02ISR Number: 3863204-2Report Type:Expedited (15-DaCompany Report #B0117185A Age:55 YR Gender:Male I/FU:F Outcome Dose Death RESPIRATORY PT Agitation Arrhythmia (INHALATION) Report Source Product Role Manufacturer Salbutamol PS Glaxo Wellcome Duration Route UNKNOWN Atherosclerosis 60MG Weekly Bipolar I Disorder Depixol SS Quetiapine SS Blood Phosphorus 400MG Three Increased Sandocal SS Confusional State 1.25MG In the Delusion Ramipril SS Drug Level Above 1MCG Per day Therapeutic 5MG Three Incoherent Alfacalcidol SS Diazepam SS Irritability 5MG Three Sudden Death Procyclidine SS Glaxo Wellcome Chlorpromazine Hydrochloride SS Glaxo Wellcome Lorazepam SS Lithium SS ORAL 225MG per day UNKNOWN times per day UNKNOWN morning UNKNOWN UNKNOWN times per day UNKNOWN times per day UNKNOWN PARENTERAL UNKNOWN 15 DAY Date:02/05/02ISR Number: 3863207-8Report Type:Expedited (15-DaCompany Report #B0121705A Age:55 YR Gender:Male I/FU:F Outcome Death 22-Aug-2005 Page: 405 PT Agitation Arrhythmia Atherosclerosis Bipolar I Disorder Confusional State Incoherent 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Irritability Sudden Death Report Source Dose Product Role Manufacturer Salbutamol PS Glaxo Wellcome Procyclidine SS Glaxo Wellcome Flupenthixol SS Quetiapine SS Sandocal SS Ramipril SS Alfacalcidol SS Diazepam SS Chlorpromazine Hydrochloride SS Lorazepam SS Lithium SS Route Duration RESPIRATORY (INHALATION) UNKNOWN 5MG Three times per day UNKNOWN 60MG Weekly UNKNOWN 225MG See dosage text UNKNOWN 400MG Three times per day UNKNOWN 1.25MG In the morning UNKNOWN 1MCG Per day UNKNOWN 5MG Three times per day Glaxo Wellcome UNKNOWN PARENTERAL UNKNOWN 15 DAY Date:02/05/02ISR Number: 3864130-5Report Type:Direct Age:49 YR Gender:Male I/FU:I Outcome Dose PT Duration Company Report #CTU 160866 Report Source Product Role Manufacturer Route Hospitalization 300 MG CAP Initial or Prolonged BID Aggression Lithium Carbonate PS Depakote Trazodone Albuterol Beclomethasone Prozac Glyburide Triamcinolone Simvastatin Lisinopril C C C C C C C C C Akinesia Apathy Catatonia Confusional State Coordination Abnormal Disorientation Pupil Fixed Sluggishness Speech Disorder Date:02/06/02ISR Number: 3866412-XReport Type:Expedited (15-DaCompany Report #2002AP00267 Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Required 1200 MG DAILY Intervention to 50 MG DAILY Prevent Permanent 100 UG DAILY Impairment/Damage PT Report Source Product Role Drug Interaction Foreign Lithium PS Heart Rate Decreased Literature Propofol SS Hypothyroidism Health Fentanyl SS Sinus Arrhythmia Professional Other Unspecified C Date:02/08/02ISR Number: 3866657-9Report Type:Direct Age:91 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 225MG BID Initial or Prolonged ORAL PT Delirium 22-Aug-2005 Page: 406 10:48 AM Route Manufacturer Route Company Report #CTU 161280 Report Source Product Role Lithium PS Vioxx C Drug Level Increased Dysarthria Sedation Manufacturer ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/12/02ISR Number: 3866887-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11712270 Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization "for years" Initial or Prolonged "for years" PT Report Source Coma Product Role Manufacturer Prolixin Inj PS Apothecon Lithium SS Route Date:02/12/02ISR Number: 3869605-0Report Type:Expedited (15-DaCompany Report #02P-087-0115047-00 Age:40 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Disability 300 MG, 1 IN PT Report Source Product Role Manufacturer Route Abdominal Pain Upper Cough Diarrhoea Foreign Health Professional Cefzon (Omnicef) (Cefdinir) (Cefdinir) PS ORAL Large Intestinal Ulcer Other Lithium Carbonate SS ORAL Bromazepam SS ORAL Loxoprofen Sodium SS ORAL Oseltamivir SS ORAL 1 D, PER ORAL Peritonitis 200 MG, 2 IN Pharyngolaryngeal Pain 1 D, PER ORAL Pyrexia 1 MG, 2 IN 1 Shock D, PER ORAL 60 MG, 3 IN 1 D, PER ORAL 75 MG, 2 IN 1 D, PER ORAL Date:02/13/02ISR Number: 3869989-3Report Type:Expedited (15-DaCompany Report #2002AP00330 Age:69 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Required 50 MG QD PO Intervention to 50 MG BID PO Prevent Permanent 42 MG BID PO Impairment/Damage 10 MG QD PO Alanine Aminotransferase Foreign Tenormin PS ORAL Increased Health Sertraline SS ORAL Amnesia Professional Lithium Sulphate SS ORAL Aspartate Other Sibutramine SS ORAL Isradipine Simvastatin Amiloride Omeprazole Losartan Furosemide C C C C C C Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Amylase Increased Blood Lactate Dehydrogenase Decreased Bradycardia Dizziness Dysphasia Gamma-Glutamyltransferase Abnormal Hypotension Tremor Date:02/13/02ISR Number: 3870278-1Report Type:Expedited (15-DaCompany Report #PHBS2002AU01746 Age:32 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Blood Sodium Decreased Drug Interaction Drug Level Increased Foreign Health Professional Lamisil (Terbinafine Hydrochloride) Tablet PS Pitting Oedema Other Lithium (Lithium) SS Modifast C 250 MG, QD, ORAL Therapeutic Agent 1) 1350 QD; Toxicity 2) 900 MG, QD Water Intoxication 22-Aug-2005 Page: 407 Manufacturer Route Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/02ISR Number: 3872280-2Report Type:Periodic Age:30 YR Gender:Male I/FU:I Outcome Dose Death MG ONCE PO Company Report #2014463 PT Report Source Product Role Manufacturer Route Intentional Misuse Health Oxycontin Cr Tablets PS ORAL Nausea Somnolence Vomiting Professional Other Oxyfast Oral Concentrate Solution 20 Mg/1ml SS ORAL Citalopram SS Darvocet (Propoxyphene/Acetam inophen) SS Effexor (Venlafaxine) SS Eskalith (Lithium Carbonate) SS Proscar C Duration 25 ML ONCE PO MG ONCE ORAL MG ONCE PO 150 MG ORAL 5 MG QD PO Date:02/13/02ISR Number: 3872400-XReport Type:Periodic Age:19 YR Gender:Male I/FU:I Outcome Dose Death Company Report #2014033 PT Report Source Product Role Accidental Overdose Drug Interaction Consumer Health Professional Other Oxycontin Cr Tablets, 10 Mg (Oxycodone Hydrochloride) PS Duration MG Valium (Diazepam) Depakote (Divalproex Sodium) Valproic Acid Lithium Date:02/19/02ISR Number: 3872924-5Report Type:Expedited (15-DaCompany Report #A129154 Age: Gender:Female I/FU:F SS SS SS SS Manufacturer Route Outcome Dose Duration Hospitalization Initial or Prolonged BID PT Report Source Product Role Jaundice Weight Increased Health Professional Zoloft Tablets Lithium PS SS Prolixin SS Depakote Cogentin Paxil Trazodone Prozac Celexa Wellbutrin Zyprexa Ecstasy SS C C C C C C C C Manufacturer Route Manufacturer Route 5.00 MG TOTAL:DAILY Date:02/20/02ISR Number: 3873391-8Report Type:Expedited (15-DaCompany Report #A0358791A Age:49 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 20 MG/ORAL PT Report Source Product Role Communication Disorder Feeling Of Despair Consumer Paxil (Paroxetine Hydrochloride) PS Loss Of Libido Suicidal Ideation Suicide Attempt 22-Aug-2005 Page: 408 10:48 AM Paroxetine Hydrochloride 60 Mg (Paroxetine ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS ORAL ORAL Lithium Salt (Lithium Salt) Olanzapine (Olanzapine) SS SS Date:02/21/02ISR Number: 3871497-0Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11712270 Age:52 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged "for years" PT Report Source Coma Product Role Manufacturer Prolixin Decanoate Inj PS Apothecon Lithium SS Route "for years" Date:02/22/02ISR Number: 3874148-4Report Type:Expedited (15-DaCompany Report #A0358950A Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG/ TWICE PT Report Source Product Role Balance Disorder Confusional State Health Professional Eskalith (Lithium Carbonate) PS Drug Level Above Company Therapeutic Mental Disorder Due To A General Medical Condition Mental Impairment Tremor Representative Paroxetine Hydrochloride Semisodium Valproate C C Manufacturer Route ORAL PER DAY/ ORAL Date:02/22/02ISR Number: 3874510-XReport Type:Expedited (15-DaCompany Report #A0358952A Age:60 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Nephritis Interstitial Nephrogenic Diabetes Health Professional Eskalith Carbonate) Role Manufacturer Route (Lithium PS ORAL Insipidus Quetiapine Fumarate Lamotrigine Magnesium Hydroxide Eye Medication (Unspec.) Clonazepam Centrum Silver C C C C C C Date:02/22/02ISR Number: 3874964-9Report Type:Expedited (15-DaCompany Report #001-0073-M0200071 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Nephritis Allergic Nephritis Interstitial Health Professional Dilantin (Phenytoin) (Lithium Carbonate) PS SS Date:02/22/02ISR Number: 3879363-1Report Type:Periodic Age:78 YR Gender:Male I/FU:I Outcome Dose Duration Death Hospitalization Initial or Prolonged 200 MG 1X PER Route Manufacturer Route Company Report #HQ7950302NOV2001 PT Report Source Product Role Neuroleptic Malignant Syndrome Pneumonia Health Professional Effexor (Venlafaxine Hydrochloride, Tablet) PS Lithium (Lithium, ) SS Pyrexia 1 DAY, ORAL Urinary Tract Infection 22-Aug-2005 Page: 409 Manufacturer Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/02ISR Number: 3873251-2Report Type:Direct Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10MG DAILY PT Company Report #CTU 162200 Report Source Drug Level Above Therapeutic Product Role Manufacturer Route Lithium Prinivil 10mg Merk PS SS Merk ORAL Manufacturer Route ORAL Date:02/25/02ISR Number: 3874251-9Report Type:Expedited (15-DaCompany Report #D0037928A2002001836-1 Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 450 MG/TWICE PT Report Source Product Role Diarrhoea Drug Level Above Foreign Health Lithium Carbonate Tablet 450 Mg PS Therapeutic Professional ORAL PER DAY/ORAL Haemodialysis Overdose Renal Failure Date:02/26/02ISR Number: 3876007-XReport Type:Expedited (15-DaCompany Report #A126997 Age:39 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 120.00 MG Initial or Prolonged TOTAL:DAILY:O Required RAL Intervention to 300.00 MG Prevent Permanent TOTAL:DAILY:O Impairment/Damage RAL PT Report Source Product Role Convulsion Health Ziprasidone Po PS ORAL Depression Professional Desipramine SS ORAL Lithobid SS Manufacturer Route Drug Interaction Drug Level Increased Medication Error Lorazepam Synthroid (Levothyroxine) Wellbutrin (Bupropion) Loestrin Chinese Herbs C C C C C Date:02/27/02ISR Number: 3880842-1Report Type:Expedited (15-DaCompany Report #D0038002A Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Required Intervention to ORAL Prevent Permanent Impairment/Damage ORAL PT Report Source Product Role Chills Dyspnoea Foreign Health Lithium Carbonate Tablet PS ORAL Euphoric Mood Hypertension Professional Paxil (Paroxetine Hydrochloride) SS ORAL Sibutramine Hydrochloride Capsule (Sibutramine Hyerochloride) SS ORAL Nervousness Serotonin Syndrome Vertigo Weight Decreased PER DAY ORAL Tibolone Thyroxine Sodium Lorazepam Noethist.Acet+Oestra diol Irbesartan Irbesartan Norethist.Acet+Oestr adiol 22-Aug-2005 Page: 410 10:48 AM C C C C C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/02ISR Number: 3875386-7Report Type:Expedited (15-DaCompany Report #WAES 0202GBR00256 Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 30 DAY Other PT Report Source Product Role Manufacturer Route Diplopia Vioxx PS Merck & Co., Inc ORAL Drug Interaction Drug Level Increased Therapeutic Agent Toxicity Tremor Vomiting Lithium Carbonate Sulfasalazine Methotrexate Sodium Oxybutynin Chloride SS C C C ORAL ORAL ORAL ORAL Date:02/28/02ISR Number: 3878230-7Report Type:Expedited (15-DaCompany Report #D0037964A Age: Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Required Intervention to Prevent Permanent 5 Impairment/Damage TABLET/SINGLE PT Report Source Product Role Intentional Misuse Suicide Attempt Vomiting Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS ORAL Lithium Carbonate Tablet 450 Mg (Non-Us Product) SS ORAL Manufacturer Route DOSE/ORAL 5 TABLET/SINGLE DOSE/ORAL Date:03/01/02ISR Number: 3876821-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU01746 Age:32 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Blood Sodium Decreased Foreign Lamisil(Terbinafine Duration Role Manufacturer Route Condition Aggravated Confusional State Health Professional Delusion Other Hydrochloride) Tablet PS Lithium(Lithium) SS Modifast Olanzapine (Olanzapine) Fluvoxamine (Fluvoxamine) C ORAL 250 MG, QD, ORAL Drug Interaction 1350 QD, : Drug Level Increased 900 MG , QD, Mental Disorder : 1125 MG , Pitting Oedema QD Suicidal Ideation Therapeutic Agent Toxicity Water Intoxication C C Date:03/04/02ISR Number: 3879021-3Report Type:Expedited (15-DaCompany Report #D0038001A Age:63 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Constipation Disorientation Hyperhidrosis Pain Foreign Health Professional Eskalith (Formulation Unknown) (Lithium Carbonate) PS Tramadol Hydrochloride (Formulatin Unknown) (Tramadol Hydrochloride) SS 450 MG / ORAL Restlessness Serotonin Syndrome 22-Aug-2005 Page: 411 Manufacturer Route Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mirtazapine (Formulation Unknown) (Mirtazapine) Celecoxib Piretanide Valerian C C C C Date:03/05/02ISR Number: 3882441-4Report Type:Expedited (15-DaCompany Report #B0260485A Age:13 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Abdominal Tenderness Alanine Aminotransferase Increased Aspartate Literature Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS Olanzapine Sertraline C C Manufacturer Route ORAL 300 MG / ORAL Aminotransferase Increased Blood Albumin Decreased Blood Pressure Decreased Body Temperature Increased Fall Heart Rate Increased Red Blood Cells Urine Positive Date:03/06/02ISR Number: 3879166-8Report Type:Direct Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1 BID Initial or Prolonged 450MG HS PT Company Report #CTU 162858 Report Source Product Role Confusional State Lithium 300mg PS Drug Toxicity Eskalith SS Date:03/06/02ISR Number: 3879760-4Report Type:Expedited (15-DaCompany Report #HQ7224417OCT2001 Age:44 YR Gender: I/FU:I Manufacturer Route Outcome Dose Death PT Report Source Product Role Manufacturer Route Drug Abuser Intentional Misuse Literature Venlafaxine (Venlafaxine Hydrochloride, Unspec) PS ORAL Anacin Aspirin Free (Acetaminophen, Tablet) SS ORAL Lithium (Lithium) SS ORAL Duration OVERDOSE AMOUNT ,ORAL ORAL OVERDOSE AMOUNT , ORAL Date:03/06/02ISR Number: 3880284-9Report Type:Expedited (15-DaCompany Report #MK200202-0370-1 Age:74 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 412 10:48 AM PT Agitation Drug Interaction Dystonia Hypertonia FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Speech Disorder Dose Report Source Product Role Foreign Health Tofranil-Pm 75 Mg Capsules 30 PS Professional Plenur (Lithium Carbonate) Seroxat (Paroxetine Hydrochloride) Manufacturer Route Manufacturer Route Duration 75 MG SS SS Date:03/07/02ISR Number: 3881249-3Report Type:Expedited (15-DaCompany Report #WAES 0202GBR00256 Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Other 50 MG/DAILY PT Report Source Product Role Drug Interaction Drug Level Increased Foreign Other Tab Vioxx (Rofecoxib) PS ORAL Lithiumco3 SS ORAL Methotrexate Sodium Oxybutynincl Sulfasalazine C C C Drug Toxicity PO 30 DAY 600 MG/DAILY PO Date:03/11/02ISR Number: 3882970-3Report Type:Expedited (15-DaCompany Report #LBID00202000638 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY PO PT Report Source Product Role Asthma Study Health Lithobid (Lithium Carbonate) PS Professional Manufacturer Route ORAL Date:03/11/02ISR Number: 3882978-8Report Type:Expedited (15-DaCompany Report #LBID00202000645 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY PO PT Report Source Product Role Condition Aggravated Drug Abuser Study Health Lithobid (Lithium Carbonate) PS Manufacturer Route ORAL Professional Date:03/13/02ISR Number: 3883225-3Report Type:Expedited (15-DaCompany Report #D0037852A2002000390-1 Age:61 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening Required Intervention to SINGLE DOSE/ Prevent Permanent ORAL Impairment/Damage PT Report Source Product Role Bradycardia Intentional Misuse Somnolence Foreign Health Professional Lithium Acetate Tablet 536 Mg (Lithium Acetate) PS Suicide Attempt Date:03/13/02ISR Number: 3885854-XReport Type:Expedited (15-DaCompany Report #A0358952A Age:60 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged Disability 22-Aug-2005 Page: 413 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent Dose Duration Impairment/Damage PT Report Source Product Role Dialysis Nephritis Interstitial Health Professional Eskalith Capsule (Lithium Carbonate) PS Quetiapine Fumarate Lamotrigine Magnesium Hydroxide Hypromellose Clonazepam Centrum Silver Paracetamol Maalox Suspension Sodium Chloride C C C C C C C C C Manufacturer Route ORAL SEE DOSAGE Nephrogenic Diabetes TEXT/ ORAL Insipidus Renal Disorder Date:03/18/02ISR Number: 3890999-4Report Type:Expedited (15-DaCompany Report #A0358950A Age:72 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to 600 MG/TWICE Prevent Permanent PER DAY/ ORAL Impairment/Damage PT Report Source Product Role Balance Disorder Bipolar Disorder Condition Aggravated Diarrhoea Health Professional Company Representative Eskalith (Formulation Unknown) (Lithium Carbonate) PS Paroxetine Hydrochloride Semisodium Valproate C C Manufacturer Route ORAL Drug Toxicity Date:03/19/02ISR Number: 3885470-XReport Type:Expedited (15-DaCompany Report #A205704 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 160.00 MG PT Report Source Product Role Depression Consumer Ziprasidone Po PS Manufacturer Route ORAL Initial or Prolonged TOTAL:BID:ORA Required L Intervention to Prevent Permanent Impairment/Damage Increased Appetite Road Traffic Accident Somnolence Suicidal Ideation Treatment Noncompliance Weight Increased Lithium Beer SS SS Date:03/19/02ISR Number: 3885958-1Report Type:Expedited (15-DaCompany Report #001-0073-M0200071 Age:57 YR Gender:Male I/FU:F Outcome Dose Duration Other 200 OR 300 MG PT Report Source Product Role Manufacturer Route Nephritis Allergic Health Dilantin (Phenytoin) PS ORAL Nephritis Interstitial Professional (Lithium Carbonate) SS ORAL (DAILY), PER Renal Failure Acute ORAL 900 MG (300 MG, TID), PER ORAL 22-Aug-2005 Page: 414 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/02ISR Number: 3886051-4Report Type:Expedited (15-DaCompany Report #A205342 Age:34 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization PO Initial or Prolonged 900.00 MG Required TOTAL:BID/ORA Intervention to L Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Blood Glucose Abnormal Health Ziprasidone Po PS ORAL Drug Level Increased Professional Lithium Carbonate SS ORAL Effexor Zyprexa Glucophage Ambien Thorazine Actos C C C C C C Electrocardiogram Qt Corrected Interval Prolonged Glycosylated Haemoglobin Increased Date:03/22/02ISR Number: 3886693-6Report Type:Expedited (15-DaCompany Report #B0262071A Age:24 YR Gender:Female I/FU:I Outcome Dose Duration Other 800MG per day PT Report Source Product Role Manufacturer Route Dry Throat Zovirax 800 PS Glaxo Wellcome ORAL Erythema Face Oedema Hypertension Kidney Enlargement Lithium Oligosol SS ORAL Date:03/22/02ISR Number: 3887587-2Report Type:Expedited (15-DaCompany Report #LBID00202000638 Age: Gender:Male I/FU:F Outcome Dose PT Report Source Product Role Asthma Study Health Lithobid (Lithium Carbonate) PS Manufacturer Route Duration DAILY PO Professional ORAL Date:03/25/02ISR Number: 3888072-4Report Type:Direct Age:33 YR Gender:Female I/FU:I Outcome Dose Disability PT Company Report #CTU 164096 Report Source Product Role Lithium Carbonate 300 Mg PS Lopid Celebrex Phentermine Prilosec C C C C Manufacturer Route Duration Arthralgia Muscular Weakness 300MG Myalgia BID->TID Date:03/26/02ISR Number: 3888241-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11784766 Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 415 10:48 AM PT Blood Potassium Decreased Diabetes Mellitus Non-Insulin-Dependent Drug Interaction Drug Level Increased Mania Tremor Report Source Product Role Manufacturer Coaprovel Tabs 300mg/12.5mg PS Bristol-Myers Squibb Company Indapamide Teralithe Atenolol Hyperium Loxapac Theralene SS SS C C C C Apothecon Route ORAL ORAL ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Parkinane Date:03/26/02ISR Number: 3888824-0Report Type:Direct Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600MG QAM Initial or Prolonged ORAL; 900MG Required QPM ORAL Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Lithium PS Manufacturer Route ORAL Drug Level Increased Irritability Tremor Vomiting PT Company Report #CTU 164255 Product Role Manufacturer Diarrhoea Drug Level Increased Renal Disorder Lithium Carbonate Caprox PS Roxanne Pharmaceuticals Syncope Tremor Lomotil Generic-Diphenoxylat e/Atropine Myl Synthroid SS C Myl Product Role Manufacturer Lithium PS Rabeprazole Clonazepam Diphenhydramine Hcl C C C Date:03/27/02ISR Number: 3890410-3Report Type:Direct Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600MG PO BID Initial or Prolonged Required Intervention to Company Report #CTU 164183 Confusional State Date:03/27/02ISR Number: 3890274-8Report Type:Direct Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged 300 MGS TID C PT Sinus Bradycardia Report Source Route Company Report #CTU 164326 Report Source Route ORAL Prevent Permanent Impairment/Damage Quetiapine Fumarate Olanzapine Mirtazapine C C C Date:03/27/02ISR Number: 3890790-9Report Type:Expedited (15-DaCompany Report #2001UW03379 Age: Gender: I/FU:F Outcome Dose Duration Required 600 MG PO Intervention to 1050 MG DAILY Prevent Permanent Impairment/Damage PT Report Source Product Role Ascites Health Seroquel "Zeneca" PS Polydipsia Professional Lithium SS Manufacturer Route ORAL Polyuria Date:03/27/02ISR Number: 3891044-7Report Type:Expedited (15-DaCompany Report #PHRM2002FR00980 Age:32 YR Gender:Female I/FU:I Outcome Dose Disability PT Report Source Product Role Retinal Detachment Retinal Haemorrhage Visual Acuity Reduced Foreign Health Professional Tegretol (Carbamazepine) Tablet PS 1 DF, BID, Other ORAL Teralithe(Lithium Carbonate) Slow 22-Aug-2005 Page: 416 Manufacturer Route Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Release Tablet SS ORAL Zyprexa (Olanzapine) Tablet SS ORAL Oral Contraceptive Nos C 400 MG, BID, ORAL 27.5 MG/DAY, ORAL Date:03/27/02ISR Number: 3891294-XReport Type:Expedited (15-DaCompany Report #D0038093A Age:33 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged 40 Required TABLET/SINGLE Intervention to DOSE/ORAL Prevent Permanent Impairment/Damage 10 PT Report Source Product Role Manufacturer Route Aspiration Caustic Injury Gastrointestinal Injury Foreign Health Professional Lithium Carbonate Tablet (Non-Us Product) PS ORAL Fluoxetine Tablet (Fluoxetine) SS ORAL ... SS ORAL Haemorrhage Intentional Misuse Mouth Injury Salivary Hypersecretion Suicide Attempt TABLET/SINGLE DOSE, ORAL 800 ML/SINGLE DOSE/ORAL Date:03/27/02ISR Number: 3891319-1Report Type:Expedited (15-DaCompany Report #D0037928A Age:54 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Accidental Overdose Coordination Abnormal Foreign Health Lithium Carbonate Tablet (Non-Us Role Manufacturer Route Required 450 MG/TWICE Intervention to PER DAY / Prevent Permanent ORAL Impairment/Damage Diarrhoea Professional Product) PS ORAL Disorientation Drug Level Increased Drug Toxicity Haemodialysis Renal Failure Date:04/01/02ISR Number: 3893126-2Report Type:Expedited (15-DaCompany Report #D0037823A Age:25 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening Hospitalization 4500 MG/PER Initial or Prolonged DAY/ ORAL Other Required Intervention to Prevent Permanent 750 MG/ PER Impairment/Damage DAY/ ORAL PT Report Source Product Role Blister Haemodialysis Foreign Health Lithium Carbonate (Non-Us Product) PS ORAL Intentional Misuse Professional Venlafaxine Hydrochloride Tablet (Venlafaxine Hydrochloride) SS ORAL Stangyl Tablet (Stangyl) SS ORAL Valproate Sodium Tablet (Valproate Sodium) SS ORAL Somnolence Suicide Attempt Manufacturer Route 500 MG/ PER DAY/ ORAL 1500 MG/PER DAY/ORAL 22-Aug-2005 Page: 417 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/02ISR Number: 3893415-1Report Type:Expedited (15-DaCompany Report #2002SE02099 Age:67 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 8 MG QD PO Initial or Prolonged 250 MG BID PO PT Report Source Product Role Manufacturer Route Drug Interaction Foreign Kenzen PS ORAL Drug Level Increased Health Theralithe SS ORAL Fall Professional Other Glucophage C Date:04/02/02ISR Number: 3893876-8Report Type:Expedited (15-DaCompany Report #A205704 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization 160.00 MG Initial or Prolonged TOTAL: BID: Required ORAL Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Depression Consumer Ziprasidone Po PS Lithium (Manufacturer Unknown) Beer SS SS Manufacturer Route ORAL Increased Appetite Road Traffic Accident Sedation Somnolence Suicidal Ideation Weight Increased Date:04/02/02ISR Number: 3894219-6Report Type:Expedited (15-DaCompany Report #A0358952A Age:60 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged SEE DOSAGE Disability TEXT / ORAL Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Aspartate Aminotransferase Health Professional Eskalith Capsule (Lithium Carbonate) PS Quetiapine Fumarate Lamotrigine Magnesium Hydroxide Hypromellose Clonazepam C C C C C Increased Nephritis Interstitial Nephrogenic Diabetes Insipidus Renal Disorder Manufacturer Route ORAL Centrum Silver Paracetamol Maalox Suspension Sodium Chloride Date:04/04/02ISR Number: 3894745-XReport Type:Direct Age:81 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG TID Initial or Prolonged ORAL PT Confusional State 10:48 AM Company Report #CTU 164952 Report Source Product Role Lithium 300mg PS Sertraline Glipizide Potassium Chloride Celecoxib Furosemide Lisipnopril Quetiapine Lorazepam C C C C C C C C Diarrhoea Drug Interaction Drug Level Above Therapeutic Drug Toxicity Hallucination, Visual Mental Status Changes Somnolence Vomiting 22-Aug-2005 Page: 418 C C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/02ISR Number: 3896151-0Report Type:Expedited (15-DaCompany Report #D0037964A Age: Gender:Male I/FU:F Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged Required 5 Intervention to TABLET/SINGLE Prevent Permanent DOSE/ORAL Impairment/Damage PT Report Source Product Role Manufacturer Route Overdose Suicide Attempt Vomiting Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS ORAL Lithium Carbonate Tablet 450 Mg (Non-Us Product) SS ORAL 5 TABLET/SINGLE DOSE/ORAL Date:04/04/02ISR Number: 3896161-3Report Type:Expedited (15-DaCompany Report #D0038195A Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Calculus Urethral Eye Operation Renal Colic Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS Manufacturer Route ORAL ORAL Date:04/05/02ISR Number: 3896325-9Report Type:Direct Age:56 YR Gender:Male I/FU:I Outcome Dose PT Company Report #CTU 165075 Report Source Product Role Asthenia Lithium PS Diarrhoea Drug Level Above Fluoxetine Synthroid C C Duration 2(300MG) TID Manufacturer Route Therapeutic Gait Disturbance Medication Error Somnolence Tremor Trazodone Naproxen C C Date:04/12/02ISR Number: 3900163-8Report Type:Expedited (15-DaCompany Report #D0038280A Age:38 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Required Intervention to Prevent Permanent ORAL Impairment/Damage PT Report Source Product Role Manufacturer Route Hallucination Hyperreflexia Somnolence Suicide Attempt Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS ORAL Melperone Hydrochloride Tablet (Melperone Hydrochloride) SS ORAL Chlorprothixene Tablet (Chlorprothixene) SS ORAL Mirtazapine Tablet (Mirtazapine) SS ORAL ORAL ORAL ORAL 22-Aug-2005 Page: 419 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/02ISR Number: 3900164-XReport Type:Expedited (15-DaCompany Report #D0038278A Age:28 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged 8 TABLET / PT Report Source Product Role Bowel Sounds Abnormal Intentional Misuse Somnolence Foreign Health Professional Lithium Carbonate Tablet (Non-Us Product) PS Flunitrazepam Promethazine Carbamazepine C C C Manufacturer Route ORAL Suicide Attempt SINGLE DOSE / Vomiting ORAL Date:04/16/02ISR Number: 3900416-3Report Type:Expedited (15-DaCompany Report #WAES 0202DEU00068 Age:71 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 6 DAY Initial or Prolonged PT Product Role Manufacturer Route Apathy Vioxx PS Merck & Co., Inc ORAL Clonic Convulsion Drug Toxicity Gait Disturbance Hypertonia Mood Altered Lithium Carbonate Levothyroxine Sodium Hydrochlorothiazide And Ramipril Allopurinol Elavil Bisoprolol Fumarate Ferrous Glycine Sulfate SS C ORAL C C C C ORAL ORAL ORAL ORAL C ORAL Date:04/16/02ISR Number: 3900671-XReport Type:Direct Age:59 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 450 MG Initial or Prolonged BID;1/25-3/4 PT Confusional State Coordination Abnormal Report Source Company Report #CTU 165768 Report Source Product Role Lithium Cr PS Manufacturer Route Drug Level Above Therapeutic Hyperhidrosis Nasopharyngitis Apap Carvedilol Chlorpromazine Clopidogrel Digoxin Folic Acid Lansoprazole Multiple Vitamin Thiamin Olanzapine C C C C C C C C C C Date:04/17/02ISR Number: 3901101-4Report Type:Expedited (15-DaCompany Report #WAES 0204SWE00002 Age:81 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 25 DAY Initial or Prolonged 22-Aug-2005 Page: 420 10:48 AM PT Report Source Product Role Manufacturer Route Blood Creatinine Vioxx PS Merck & Co., Inc ORAL Increased Depressed Level Of Consciousness Drug Level Increased Extrapyramidal Disorder Lithium Sulfate Zolpidem Tartrate Levothyroxine Sodium Lofepramine Hydrochloride Dipyridamole Calcium Carbonate And Cholecalciferol Tramadol SS C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride C Date:04/17/02ISR Number: 3903040-1Report Type:Expedited (15-DaCompany Report #2002101362US Age: Gender: I/FU:I Outcome Dose Other ORAL PT Report Source Product Role Drug Interaction Grand Mal Convulsion Health Professional Medrol (Methylprednisolone) Tablet PS Zyprexa (Olanzapine) Lithium Propranolol Levothyroxine SS SS SS SS Manufacturer Route Duration 1 ORAL DAY Date:04/18/02ISR Number: 3902840-1Report Type:Expedited (15-DaCompany Report #K200200544 Age:79 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged 2.5 MG, QD, PT Report Source Product Role Manufacturer Route Blood Glucose Decreased Blood Pressure Decreased Bradycardia Foreign Health Professional Altace Capsules (Ramipril) Capsule, 1.25 Mg PS ORAL Condition Aggravated Other Hydrochlorothiazide SS ORAL Lithium-Duriles (Lithium Sulfate) SS ORAL Nebilet (Nebivolol Hydrochloride) SS ORAL Ass "Ct-Arzneimittel" (Acetylsalicylic Acid) SS ORAL ORAL Cyanosis 2.5 MG, QD, Hyperglycaemia ORAL Renal Impairment Somnolence 42 MG, ORAL 5 MG, ORAL 100 MG, ORAL Haloperidol-Ratiopha rm (Haloperidol) SS Ratiopharm ORAL Digitoxin "Awd" (Digitoxin) SS ORAL Sarptem "Bayer Vital" (Amitriptyline Hydrochloride) SS ORAL Allopurinol SS ORAL 5 MG, ORAL 0.07 MG, ORAL 25 MG, ORAL 100 MG, ORAL Akatinol (Memantine Hydrochloride) Venoruton Retard (Troxerutin) Amaryl (Glimepiride) Diastabol (Miglitol) Espa-Lipon (Thioctic Acid) Nitrendipine C C C C C C Date:04/18/02ISR Number: 3903136-4Report Type:Expedited (15-DaCompany Report #A044-002-003658 Age:87 YR Gender:Female I/FU:I Outcome Dose Other 5 MG 1 IN 1 PT Report Source Product Role Drug Level Decreased Foreign Aricept (Donepezil) PS ORAL Priadel (Lithium Carbonate) SS ORAL Manufacturer Route Duration Health D, PER ORAL Professional 400 MG, PER 22-Aug-2005 Page: 421 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Paroxetine (Paroxetine) Date:04/19/02ISR Number: 3903845-7Report Type:Direct Age:39 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300MG TID Initial or Prolonged ORAL Required Intervention to Prevent Permanent Impairment/Damage PT Drug Level Above Therapeutic Pyrexia Vomiting PT Product Role Lithium PS Valproic Acid Carbamazepine Sertraline Cenestin Risperidone Ranitidine Lomotil Zolpidem Clonazepam C C C C C C C C C Manufacturer Route ORAL Company Report #CTU 166252 Report Source Confusional State Product Role Lithium PS Manufacturer Route Manufacturer Route Drug Level Changed Lethargy Leukocytosis Mental Impairment Tremor PT Duration Report Source Convulsion Date:04/22/02ISR Number: 3904512-6Report Type:Direct Age:53 YR Gender:Male I/FU:I Outcome Dose Company Report #CTU 166158 Asthenia Date:04/20/02ISR Number: 3904190-6Report Type:Direct Age:61 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600 BID Initial or Prolonged C Company Report #CTU 166326 Report Source Product Role Disability Agitation Cerebellar Syndrome Coma Coordination Abnormal Drug Level Increased Eye Movement Disorder Nephrogenic Diabetes Insipidus Neurotoxicity Lithium Hydrochlorothiazide Synthroid Date:04/22/02ISR Number: 3904838-6Report Type:Expedited (15-DaCompany Report #WAES 0202DEU00068 Age:71 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 422 10:48 AM PT Apathy Clonic Convulsion Dehydration Drug Interaction Gait Disturbance Hypertonia Mood Altered Oligodipsia Therapeutic Agent PS C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Toxicity Dose Report Source Product Role Manufacturer Route Foreign Health Tab Vioxx (Rofecoxib) PS ORAL Tab Cr SS ORAL Duration 12.5 MG BID Professional PO 6 DAY Lithiumco3 600 MG DAILY PO Elavil Allopurinol Bisoprolol Fumarate Ferrous Glycine Sulfate Hydrochlorothiazide (+) Ramipril Levothyroxine Na C C C C C C Date:04/22/02ISR Number: 3904960-4Report Type:Expedited (15-DaCompany Report #A208620 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Anorexia Foreign Lithane Tablets PS ORAL Apathy Health Lisinopril SS ORAL Confusional State Professional Metformin SS ORAL Depressed Level Of Furosemide SS ORAL Consciousness Drug Level Above Therapeutic Loss Of Consciousness Acetylsalicylic Acid Codeine C C ORAL ORAL Date:04/22/02ISR Number: 3905069-6Report Type:Expedited (15-DaCompany Report #D0038195A Age:63 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Calculus Ureteric Corneal Disorder Corneal Transplant Renal Colic Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS Manufacturer Route ORAL 450 MG / Thermal Burn TWICE PER DAY / ORAL Cyclosporin Glibenclamide Metoprolol Succinate Clopidogrel Bisulphate C C C C Date:04/24/02ISR Number: 3907364-3Report Type:Expedited (15-DaCompany Report #A208548 Age:15 YR Gender:Female I/FU:I Outcome Dose Duration Required Intervention to 80.00 MG Prevent Permanent TOTAL:BID: Impairment/Damage ORAL 22-Aug-2005 Page: 423 10:48 AM PT Report Source Product Role Developmental Delay Pyelonephritis Health Professional Lithane Tablets Ziprasidone PS SS Clozaril Depakote Cogentin C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/02ISR Number: 3912778-1Report Type:Periodic Age:39 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Disability 600 MG / Company Report #A0352252A 2001021273-1 PT Report Source Product Role Nephrogenic Diabetes Insipidus Health Professional Lithium Carbonate Capsule 300 Mg (Lithium Carbonate) PS Manufacturer Route ORAL TWICE PER DAY / ORAL Carbamazepine Valproic Acid Thyroxine Sodium Paroxetine Hydrochloride Loratadine Date:04/26/02ISR Number: 3907556-3Report Type:Direct Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 2.5MG BID Initial or Prolonged ORAL PT Blood Pressure Systolic C C C C C Company Report #CTU 166665 Report Source Product Role Manufacturer Route Metolazone 2.5mg PS ORAL Lithium Carbonate 300mg SS ORAL Carvedilol Furosemide Potassium Pantopraxole Ramipril Valproic Acid Glipizide Insulin C C C C C C C C Decreased Dizziness Drug Level Above 300MG BID Therapeutic ORAL Feeling Hot Hypertension Syncope Date:04/26/02ISR Number: 3908176-7Report Type:Expedited (15-DaCompany Report #2001UW03379 Age: Gender: I/FU:F Outcome Dose Duration Required 600 MG PO Intervention to 1050 MG DAILY Prevent Permanent Impairment/Damage PT Report Source Product Role No Adverse Drug Effect Health Seroquel "Zeneca" PS Professional Lithium SS Manufacturer Route ORAL Date:04/26/02ISR Number: 3908238-4Report Type:Expedited (15-DaCompany Report #D0038348A Age:39 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged 22500 MG / PT Report Source Product Role Diarrhoea Nausea Overdose Foreign Health Professional Lithium Carbonate Tablet (Non-Us Product) PS Suicidal Ideation SINGLE DOSE/ Suicide Attempt ORAL Vomiting 22-Aug-2005 Page: 424 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/02ISR Number: 3908377-8Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Other PT Company Report #CTU 166764 Report Source Product Role Lithium Tylenol Glyburide Levoxyl Wellbutrin Sr Klor-Con Prevacid Claritin Seroquel Vioxx PS C C C C C C C C C Manufacturer Route Manufacturer Route Duration Abdominal Pain Date:04/29/02ISR Number: 3909852-2Report Type:Expedited (15-DaCompany Report #A205342 Age:34 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization ORAL Initial or Prolonged 900.00 MG Required KTOTAL;BID;OR Intervention to AL Prevent Permanent 225.00 MG Impairment/Damage TOTAL;DAILY;O PT Report Source Product Role Diabetes Mellitus Health Ziprasidone Po PS ORAL Drug Level Below Professional Lithium Carbonate SS ORAL Venlafaxine SS ORAL Thorazine SS ORAL Zyprexa Glucophage Ambien Actos C C C C Therapeutic Electrocardiogram Qt Prolonged Glycosylated Haemoglobin Increased RAL Medication Error 100.00 MG TOTAL;DAILY;O RAL Date:04/30/02ISR Number: 3908287-6Report Type:Expedited (15-DaCompany Report #B0262071A Age:24 YR Gender:Female I/FU:F Outcome Dose PT Report Source Product Role Manufacturer Route Zovirax 200 PS Glaxo Wellcome ORAL Lithium Oligosol SS Duration Dry Throat 200MG Twice Erythema per day 1 DAY Face Oedema ORAL 1AMP Per day Hypertension Kidney Enlargement Date:05/01/02ISR Number: 3909437-8Report Type:Expedited (15-DaCompany Report #WAES 0204USA02770 Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 425 10:48 AM PT Asthenia Dehydration Dizziness Nausea Toxicologic Test Abnormal Report Source Product Role Manufacturer Route Vioxx Lithium Carbonate PS SS Merck & Co., Inc ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/02ISR Number: 3909996-5Report Type:Direct Age:38 YR Gender:Male I/FU:I Outcome Dose Other PT Company Report #CTU 167014 Report Source Product Role Lithium 4t (300mg) Qhs Lorazepam 1mg Tid PS SS Manufacturer Route Manufacturer Route Duration Confusional State Drug Level Changed Memory Impairment Date:05/01/02ISR Number: 3911066-7Report Type:Expedited (15-DaCompany Report #PHBS2002CH05281 Age:79 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Accidental Exposure Coma Foreign Health Leponex(Clozapine) Tablet PS Disturbance In Attention Drug Interaction Hypothermia Miosis Stupor Toxicologic Test Abnormal Professional Other Lithium (Lithium) Glucophage Forte Tiatral Fosamax (Alendronate Sodium) Calcimagon Importal Xalatan (Latanoprost) Amiodarone (Amiodarone) Nitroderm ORAL ORAL Date:05/02/02ISR Number: 3911540-3Report Type:Direct Age:72 YR Gender:Male I/FU:I Outcome Dose PT PER TUBE C C C C C C Company Report #CTU 167231 Report Source Product Role Manufacturer Lithium Salts 8 Meq/5 Ml Syrup Roxane PS Roxane Duration Medication Error Overdose 100 MG Q8H SS C C Route Date:05/07/02ISR Number: 3913277-3Report Type:Expedited (15-DaCompany Report #B0266535A Age:37 YR Gender:Female I/FU:I Outcome Dose Duration Death Hospitalization Initial or Prolonged PT Report Source Product Dialysis Drug Toxicity Neurotoxicity Sepsis Foreign Literature Health Professional Eskalith (Formulation Unknown) (Lithium Carbonate) Clopenthixol Decanoate Haloperidol Maprotiline Role Manufacturer Route Manufacturer Route PS C C C Date:05/07/02ISR Number: 3913484-XReport Type:Expedited (15-DaCompany Report #A0360110A Age:59 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged ORAL/SEE PT Report Source Product Role Confusional State Disorientation Foreign Health Paxil (Paroxetine Hydrochloride) PS ORAL Drug Toxicity Professional Eskalith (Lithium Carbonate) SS ORAL DOSAGE TEXT Hallucination Tremor ORAL/SEE 22-Aug-2005 Page: 426 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DOSAGE TEXT Lansoprazole Oxazepam C C Date:05/07/02ISR Number: 3913492-9Report Type:Expedited (15-DaCompany Report #D0038405A Age:48 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Blood Creatinine Increased Clonic Convulsion Foreign Health Professional Eskalith TabletControlled Release (Lithium Carbonate) PS Manufacturer Route ORAL ORAL Convulsion Drug Toxicity Dysarthria Somnolence Tremor Date:05/07/02ISR Number: 3913680-1Report Type:Expedited (15-DaCompany Report #A0367112A Age:36 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Abdominal Distension Abdominal Pain Upper Asthenia Fatigue Consumer Lithium Salt (Formulation Unknown) (Generic) (Lithium Salt PS Multiple Medication (Formulation Unknown) (Multiple Medication) SS Manufacturer Route ORAL PER DAY ORAL Gastrointestinal Disorder Gastrointestinal Ulcer Myalgia Nausea Overdose Pain Date:05/07/02ISR Number: 3913746-6Report Type:Expedited (15-DaCompany Report #B0266433A Age:45 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Death Hospitalization Initial or Prolonged 22-Aug-2005 Page: 427 10:48 AM Asthenia Blood Sodium Decreased Blood Urea Increased Coma Depression Diabetic Ketoacidosis Diarrhoea Dizziness Drug Interaction Drug Toxicity Electrocardiogram T Wave Inversion Mania Sepsis Somnolence Vomiting Foreign Literature Health Professional Eskalith (Lithium Carbonate) Haloperidol Antidepressant PS C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/02ISR Number: 3913963-5Report Type:Expedited (15-DaCompany Report #A209649 Age:56 YR Gender:Female I/FU:I Outcome Dose Duration Required TID:ORAL Intervention to 300.00 MG Prevent Permanent TOTAL:DAILY:O Impairment/Damage RAL PT Report Source Product Role Dizziness Consumer Lithane Tablets PS ORAL Gabapentin SS ORAL Prevacid Unknown Stool Softener C Fatigue Manufacturer Route Nausea Osteoporosis Parkinson'S Disease C Date:05/07/02ISR Number: 3915181-3Report Type:Expedited (15-DaCompany Report #WAES 0204USA02770 Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 25 Initial or Prolonged MG/DAILY/PO PT Report Source Product Role Asthenia Health Tab Vioxx 25 Mg PS Dehydration Professional Lithiumco3 Unk SS Dizziness Nausea Date:05/10/02ISR Number: 3914864-9Report Type:Direct Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900MG BEDTIME PT Manufacturer Route ORAL Company Report #CTU 167830 Report Source Product Role Manufacturer Confusional State Drug Interaction Lithium Carbonate 300mg Roxane PS Roxane Drug Level Increased Prinivil 10mg Merck SS Merck Dysarthria Neurontin Topamax Lorazepam Clonazepam C C C C 10MG DAILY Route Lipitor Premarin Glucophage C C C Date:05/13/02ISR Number: 3916546-6Report Type:Expedited (15-DaCompany Report #D0038482A Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Hypertension Somnolence Suicide Attempt Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS ORAL Galantamine Hydrobromide Tablet (Galantamine Hydrobromide) SS ORAL Olanzapine Tablet (Olanzapine) SS ORAL Venlafaxine Hydrochloride Tablet (Venlafaxine Hydrochloride) SS ORAL Route SINGLE DOSE / ORAL SINGLE DOSE / ORAL SINGLE DOSE / ORAL SINGLE DOSE / ORAL Amitriptyline Hcl 22-Aug-2005 Page: 428 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablet (Amitriptyline Hcl) SS ORAL SINGLE DOSE / ORAL Date:05/16/02ISR Number: 3918250-7Report Type:Expedited (15-DaCompany Report #D0038479A Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Blood Creatine Phosphokinase Increased Head Injury Intentional Misuse Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS ORAL Carbamazepine Tablet SS ORAL Prothipendyl Hc1 Tablet SS Route 50 Muscle Spasms TABLET/SINGLE Somnolence DOSE/ORAL 1 DAY Suicide Attempt 100 Therapeutic Agent TABLET/SINGLE Toxicity DOSE/ORAL 1 DAY 20 TABLET/SINGLE DOSE/ORAL 1 DAY Date:05/16/02ISR Number: 3918254-4Report Type:Expedited (15-DaCompany Report #D0038405A Age:49 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Asthenia Blood Creatinine Increased Blood Potassium Decreased Clonic Convulsion Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS Manufacturer Route ORAL Coma Convulsion Drug Toxicity Dysarthria Haemodialysis Renal Impairment Somnolence Tremor Date:05/16/02ISR Number: 3918305-7Report Type:Expedited (15-DaCompany Report #D0038348A Age:39 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged 22500 MG / PT Report Source Product Role Diarrhoea Dizziness Drug Level Above Foreign Health Professional Lithium Carbonate Tablet (Non-Us Product) PS Therapeutic SINGLE DOSE/ Intentional Misuse ORAL Nausea Suicide Attempt Vomiting 22-Aug-2005 Page: 429 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/02ISR Number: 3920411-8Report Type:Direct Age:27 YR Gender:Female I/FU:I Outcome Dose Duration Required 100MG PO BID Intervention to BID Prevent Permanent 10 MG/D Impairment/Damage PT Company Report #CTU 168559 Report Source Iritis Product Role Manufacturer Route Topiramate PS Ortho-Mcneil ORAL Citalopram SS Lithium Gabapentin SS SS 400 MG/D Date:05/22/02ISR Number: 3919892-5Report Type:Expedited (15-DaCompany Report #WAES 0205USA01719 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Coma Medication Error Oedema Peripheral Speech Disorder Consumer Vioxx Lithium Carbonate Paxil Glucophage Glucotrol Prilosec Lipitor Metamucil [Therapy Unspecified] PS SS SS C C C C C Merck & Co., Inc ORAL Manufacturer Route C Date:05/22/02ISR Number: 3920930-4Report Type:Expedited (15-DaCompany Report #A211114 Age:24 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged PT Report Source Product Role Renal Failure Health Professional Lithane Tablets Prinivil Olanzapine PS SS C Date:05/22/02ISR Number: 3922163-4Report Type:Expedited (15-DaCompany Report #A210947 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 40.00 MG Initial or Prolonged TOTAL: BID: PT Report Source Product Role Akathisia Health Ziprasidone Po PS Depression Professional Lithium SS Haldol SS Effexor SS Manufacturer Route ORAL Parkinsonian Gait ORAL Tremor 300.00 MG TOTAL ORAL 3.00 MG TOTAL: ORAL Date:05/23/02ISR Number: 3921617-4Report Type:Direct Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG QID Required ORAL Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 430 10:48 AM PT Alcohol Withdrawal Syndrome Company Report #CTU 168819 Report Source Product Role Manufacturer Route Lithium Carbonate 300 Mg Generic PS Generic ORAL Androderm Zantac Lopid Levoxyl Tenormin C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Navane C Date:05/24/02ISR Number: 3923172-1Report Type:Expedited (15-DaCompany Report #D0038507A Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage 10 TABLET PT Report Source Product Role Manufacturer Route Agitation Intentional Misuse Suicide Attempt Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS ORAL Perphenazine (Formulation Unknown) (Perphenazine) SS ORAL Promethazine Hcl(Formulation Unknown) (Promethazine Hcl) SS ORAL Zopiclone Tablet (Zopiclone) SS ORAL Ethanol (Formulation Unknown) (Alcohol) SS ORAL /SINGLE DOSE/ ORAL SINGLE DOSE/ ORAL SINGLE DOSE/ORAL SINGLE DOSE/ORAL 1 BOTTLE/SINGLE DOSE /ORAL Date:05/24/02ISR Number: 3926845-XReport Type:Periodic Age:46 YR Gender:Male I/FU:I Outcome Dose Other Company Report #310506 PT Report Source Product Role Manufacturer Route Confusional State Drug Effect Decreased Consumer Tamiflu (Oseltamivir) 75 Mg PS ORAL Klonopin (Clonazepam( SS ORAL Keflex (Cephalexin) SS ORAL Serzone (Nefazodone Hydrochloride) SS ORAL Lithobid (Lithium Carbonate) SS ORAL Duration 75 MG 2 PER Headache ORAL ORAL ORAL ORAL ORAL Date:05/28/02ISR Number: 3924327-2Report Type:Expedited (15-DaCompany Report #A211178 Age: Gender:Female I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 431 10:48 AM PT Report Source Product Role Delusion Disease Recurrence Mental Disorder Refusal Of Treatment By Patient Consumer Zoloft Tablets Lithium (Manufacturer Unknown) Unspecified Psychiatric Medication PS SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/02ISR Number: 3925881-7Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report #A116511 PT Report Source Product Role Tremor Health Professional Lithane Tablets Ziprasidone Ativan (Lorazepam) Luvox (Fluvoxamine Maleate) Depakote (Valproate) PS SS C Manufacturer Route Manufacturer Route C C Date:05/29/02ISR Number: 3926094-5Report Type:Expedited (15-DaCompany Report #D0038587A Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Other Required Intervention to Prevent Permanent 60 TABLET/ Impairment/Damage SINGLE DOSE/ PT Report Source Product Role Coma Intentional Misuse Suicide Attempt Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS ORAL Olanzapine Tablet (Olanzapine) SS ORAL ORAL 27 TABLET/ SINGLE DOSE/ ORAL Date:05/29/02ISR Number: 3926096-9Report Type:Expedited (15-DaCompany Report #B0268009A Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required ORAL MONTHS PT Report Source Product Role Drug Level Increased Headache Intentional Misuse Foreign Literature Health Lithium Carbonate Tablet (Non-Us Product) PS Manufacturer Route ORAL Intervention to Prevent Permanent Impairment/Damage Nausea Suicide Attempt Professional Risperidone Fluoxetine C C Date:05/29/02ISR Number: 3926134-3Report Type:Expedited (15-DaCompany Report #D0038278A Age:28 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Bowel Sounds Abnormal Intentional Misuse Somnolence Foreign Health Professional Lithium Carbonate Tablet (Non-Us Product) PS Flunitrazepam Promethazine Carbamazepine C C C Manufacturer Route ORAL 8 TABLET / Suicide Attempt SINGLE DOSE / Vomiting ORAL Date:05/29/02ISR Number: 3926649-8Report Type:Expedited (15-DaCompany Report #WAES 0205USA01719 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization PO Initial or Prolonged 22-Aug-2005 Page: 432 10:48 AM PT Report Source Product Role Coma Consumer Vioxx 25 Mg PS Lithiumco3 Paxil Glucophage SS SS C Medication Error Mutism Oedema Peripheral Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glucotrol Lipitor Metamucil Prilosec [Therapy Unspecified] Date:06/03/02ISR Number: 3926864-3Report Type:Direct Age:50 YR Gender:Male I/FU:I Outcome Dose Other PT C C C C C Company Report #CTU 169359 Report Source Product Role Manufacturer Route Lithium Carbonate Caps 300mg Able PS Able ORAL Manufacturer Route Duration Face Oedema Pharmaceutical Product 2 CAPSU TWICE Complaint DAILY ORAL Date:06/04/02ISR Number: 3929100-7Report Type:Expedited (15-DaCompany Report #A209649 Age: Gender:Female I/FU:F Outcome Dose Duration Required TID: ORAL Intervention to 300.00 MG Prevent Permanent TOTAL: DAILY: Impairment/Damage ORAL PT Report Source Product Role Balance Disorder Consumer Lithane Tablets PS ORAL Bone Disorder Health Gabapentin SS ORAL Confusional State Professional Prevacid Unknown Stool Softener Welbutrin Sr C Dizziness Fatigue Nausea Osteoporosis Parkinson'S Disease Tremor Date:06/04/02ISR Number: 3929250-5Report Type:Expedited (15-DaCompany Report #D0038002A Age:58 YR Gender:Female I/FU:F C C Outcome Dose Duration Required Intervention to Prevent Permanent ORAL Impairment/Damage PT Report Source Product Role Chills Dyspnoea Euphoric Mood Foreign Health Professional Lithium Carbonate Tablet 450mg (Non-Us Product) PS ORAL Sibutramine Hydrochloride Capsule (Sibutramine Hydrochloride) SS ORAL Paxil (Formulation Unknown) (Paroxetine Hydrochloride) SS ORAL Hyperhidrosis Hypertension Serotonin Syndrome Tremor Manufacturer Route PER DAY / Vertigo ORAL Weight Decreased ORAL Tibolone Thyroxine Sodium Lorazepam Norethis.Acet+Oestra diol Irbesartan Date:06/05/02ISR Number: 3928318-7Report Type:Direct Age:39 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 433 10:48 AM Company Report #CTU 169532 C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Dose Report Source Confusional State Depressed Level Of Consciousness Dialysis Diarrhoea Drug Interaction Drug Level Increased Lethargy Staring Urinary Incontinence Vomiting Date:06/05/02ISR Number: 3928370-9Report Type:Direct Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Role Lithium 300mg Tid Lisinopril 5mg Qd PS SS Manufacturer Route Manufacturer Route Outcome Dose Duration Hospitalization Initial or Prolonged Manufacturer Route PT Report Source PT Product Role Lithium PS Manufacturer Route Company Report #CTU 169517 Report Source Dizziness Drug Level Increased Dysarthria Fall Medication Error Date:06/05/02ISR Number: 3928469-7Report Type:Direct Age:67 YR Gender:Male I/FU:I Duration Company Report #CTU 169549 Diabetes Insipidus Date:06/05/02ISR Number: 3928436-3Report Type:Direct Age:57 YR Gender:Female I/FU:I Outcome Dose Product Duration Product Role Lithium Carbonate (Lithobid) PS Company Report #CTU 169569 Report Source Product Role Hospitalization 450MG BID PO Initial or Prolonged Diarrhoea Lithium Carbonate PS Drug Toxicity Haemodialysis Mental Status Changes Oedema Peripheral Oral Intake Reduced Renal Failure Acute Sinus Bradycardia Tremor Latanoprost Opth Tamsulosin Timolol Opth Aspirin Naproxen Ranitidine Trazodone Metoprolol C C C C C C C C ORAL Date:06/05/02ISR Number: 3929533-9Report Type:Expedited (15-DaCompany Report #A211751 Age: Gender:Male I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 434 10:48 AM PT Report Source Product Role Anxiety Renal Cell Carcinoma Stage Unspecified Consumer Lithane Tablets PS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/02ISR Number: 3930705-8Report Type:Expedited (15-DaCompany Report #001-0981-M0202875 Age:59 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Crying Drug Interaction Consumer Atorvastatin (Atorvastatin) PS Manufacturer Route Duration ORAL 10 MG Feeling Abnormal (DAILY), PER Suicidal Ideation ORAL Tremor Gabapentin Lithium Paroxetine Hydrochloride Trazadone Buspirone Enalapril SS SS SS SS SS C Date:06/06/02ISR Number: 3929788-0Report Type:Expedited (15-DaCompany Report #044-0945-M0200083 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Neuroleptic Malignant Syndrome Foreign Health Neurontin (Gabapentin) PS Lithium SS ... SS Manufacturer Route Manufacturer Route Duration 1200 MG Professional (DAILY), 1200 MG (DAILY), Date:06/07/02ISR Number: 3929441-3Report Type:Direct Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1000 MG BID PT Intentional Misuse Company Report #CTU 169676 Report Source Product Role Depakote PS Initial or Prolonged 1 MG PO BID Lethargy Risperidone SS Stupor Lithium SS Vision Blurred Quetiapine SS Hydroxyzine Naproxen Citalopram Lorazepam C C C C ORAL 450 MG BID 200 MG BID Date:06/07/02ISR Number: 3930987-2Report Type:Expedited (15-DaCompany Report #B0269250A Age: Gender:Female I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent 250 MG TWICE Impairment/Damage PER DAY ORAL 20 MG PER DAY ORAL 22-Aug-2005 Page: 435 10:48 AM PT Report Source Product Role Manufacturer Route Serotonin Syndrome Tinnitus Foreign Health Professional Lithium Carbonate Tablet (Non-Us Product) PS ORAL Paxil Tablet (Paroxetine Hydrochloride) SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/02ISR Number: 3934080-4Report Type:Expedited (15-DaCompany Report #D0038633A Age:35 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Agitation Bowel Sounds Abnormal Dysarthria Foreign Health Professional Eskalith Tablet Controlled Release (Lithium Carbonate) PS ORAL Olanzapine Tablet (Olanzapine) SS ORAL Citalopram Tablet (Citalopram) SS ORAL Thyroxine Sodium Tablet (Levothyroxine Sodium) SS ORAL Prothipendyl Hcl Tablet (Prothipendyl Hcl) SS ORAL Manufacturer Route 90 TABLET/ Enuresis SINGLE DOSE/ Faecal Incontinence ORAL Haemodialysis Intentional Misuse 20 TABLET/ Suicide Attempt SINGLE DOSE/ ORAL 20 TABLET/ SINGLE DOSE/ ORAL 50 TABLET/ SINGLE DOSE/ ORAL 10 TABLET/ SINGLE DOSE/ ORAL Date:06/10/02ISR Number: 3930915-XReport Type:Direct Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Company Report #CTU 169794 Report Source Polydipsia Product Role Lithium PS Manufacturer Route Manufacturer Route Date:06/10/02ISR Number: 3931377-9Report Type:Expedited (15-DaCompany Report #2002101362US Age: Gender: I/FU:F Outcome Dose Other ORAL PT Report Source Product Role Drug Interaction Grand Mal Convulsion Health Professional Medrol(Methylprednis olone)Tablet PS Duration 1 DAY Zyprexa (Olanzapine) Lithium (Lithium) Propranolol(Proprano lol) Levothyroxine(Levoth yroxine) Date:06/12/02ISR Number: 3936716-0Report Type:Expedited (15-DaCompany Report #D0038482A Age:53 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 436 10:48 AM PT Convulsion Disorientation SS SS SS SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertension Intentional Misuse Somnolence Dose Report Source Product Role Manufacturer Route Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS ORAL Galantamine Hydrobromide Tablet (Galantamine Hydrobromide) SS ORAL Olanzapine Tablet (Olanzapine) SS ORAL Venlafaxine Hydrochloride Tablet (Venlafaxine Hydrochloride) SS ORAL Unknown Tablet (Unknown) SS ORAL Amitriptyline Hcl Tablet (Amitriptyline Hcl) SS ORAL Duration Suicide Attempt Urinary Incontinence 3 TABLET / SINGLE DOSE/ ORAL 3 TABLET/ SINGLE DOSE/ ORAL 3 TABLET/ SINGLE DOSE/ ORAL 4 TABLET/ SINGLE DOSE/ ORAL SINGLE DOSE/ ORAL SINGLE DOSE/ ORAL Date:06/13/02ISR Number: 3934077-4Report Type:Expedited (15-DaCompany Report #D0038001A Age:63 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Constipation Pain Serotonin Syndrome Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS ORAL Mirtazapine (Formulation Unknown) (Mirtazapine) SS ORAL Tramadol Hydrochloride (Formulation Unknown) SS ORAL Route Duration 450 MG /ORAL ORAL ORAL Celecoxib Piretanide Valerian Tizanidine Hydrochloride 22-Aug-2005 Page: 437 10:48 AM C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/13/02ISR Number: 3934078-6Report Type:Expedited (15-DaCompany Report #B0269250A Age: Gender:Female I/FU:I Outcome Dose Duration Required Intervention to 250 MG/TWICE Prevent Permanent PER DAY/ORAL Impairment/Damage PT Report Source Product Role Manufacturer Route Diarrhoea Serotonin Syndrome Foreign Health Lithium Carbonate Tablet PS ORAL Paxil Tablet (Paroxetine Hydrochloride) SS ORAL Professional 20 MG PER DAY/ORAL Date:06/14/02ISR Number: 3934539-XReport Type:Expedited (15-DaCompany Report #A213023 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 900.00 MG Initial or Prolonged TOTAL Other 600.00 MG PT Report Source Product Role Unevaluable Event Consumer Lithane PS Gabapentin SS Manufacturer Route Manufacturer Route TOTAL:DAILY Date:06/19/02ISR Number: 3940307-5Report Type:Expedited (15-DaCompany Report #D0038737A Age:20 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Required Intervention to 11 TABLET / Prevent Permanent SINGLE DOSE / PT Report Source Product Role Intentional Misuse Suicidal Ideation Foreign Health Professional Lithium Carbonate Tablet (Non-Us Product) PS ORAL Impairment/Damage ORAL Date:06/19/02ISR Number: 3940436-6Report Type:Expedited (15-DaCompany Report #D0038507A Age:47 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to SINGLE Prevent Permanent DOSE/ORAL Impairment/Damage PT Report Source Product Role Manufacturer Route Agitation Alanine Aminotransferase Increased Blood Creatine Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS ORAL Perphenazine (Formulation Unknown) (Perphenazine) SS ORAL Promethazine Hcl (Formulation Unknown) (Promethazine Hcl) SS ORAL Zopiclone Tablet (Zopiclone) SS ORAL Ethanol (Formulation Unknown) (Alochol) SS ORAL Phosphokinase Increased Diarrhoea Gamma-Glutamyltransferase Increased Overdose SINGLE Somnolence DOSE/ORAL Suicide Attempt Tachycardia White Blood Cell Count Increased SINGLE DOSE/ORAL SINGLE DOSE/ORAL 1 BOTTLE/SINGLE DOSE/ORAL 22-Aug-2005 Page: 438 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/02ISR Number: 3937915-4Report Type:Expedited (15-DaCompany Report #LBID00202000638 Age: Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Asthma Study Health Lithobid (Lithium Carbonate) PS Manufacturer Route Duration ORAL DAILY PO Professional Date:06/20/02ISR Number: 3940466-4Report Type:Expedited (15-DaCompany Report #D0035086A 1999031048-1 Age:65 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Delirium Disorientation Disturbance In Attention Fall Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS Manufacturer Route Manufacturer Route 450 MG/PER Hallucinations, Mixed DAY Head Injury Laceration Restlessness Valproate Sodium Aspirin Doxepin Hydrochloride C C C Date:06/20/02ISR Number: 3940470-6Report Type:Expedited (15-DaCompany Report #D0034945A Age:65 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Agitation Delirium Disorientation Disturbance In Attention Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS 450 MG/PER Electroencephalogram DAY/ORAL Abnormal Fall Fumbling Hallucinations, Mixed Valproate Sodium Doxepin Hydrochloride Aspirin C C C ORAL Head Injury Laceration Lethargy Nervous System Disorder Restlessness Date:06/21/02ISR Number: 3937971-3Report Type:Expedited (15-DaCompany Report #001-0945-M0200710 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG PT Report Source Product Role Unevaluable Event Consumer Neurontin (Gabapentin) PS Lithium SS Manufacturer Route (DAILY) 900 MG Date:06/24/02ISR Number: 3937895-1Report Type:Direct Age:8 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300MGS TWICE DAILY ORAL; 600MGS TWICE 22-Aug-2005 Page: 439 10:48 AM PT Blood Thyroid Stimulating Hormone Increased Company Report #CTU 170792 Report Source Product Role Manufacturer Route Lithium Carbonate 300mg Roxane Labs PS Roxane Labs ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAILY ORAL Date:06/24/02ISR Number: 3941740-8Report Type:Expedited (15-DaCompany Report #NSADSS2002009867 Age:73 YR Gender:Male I/FU:F Outcome PT Dose Duration Life-Threatening Acute Myocardial Hospitalization Infarction Initial or Prolonged Blood Glucose Increased Other Bronchospasm INTRAVENOUS 300 MG, 1 IN Required Bundle Branch Block Left 1 TIME(S), IV Intervention to Cardiac Failure 25, DAILY Prevent Permanent Congestive Impairment/Damage Cardiotoxicity 7.5 MG, 1 IN Dehydration 1 WEEK(S) Duodenal Ulcer Haemorrhage General Physical Health Deterioration Haemoptysis Heart Rate Increased Hyperhidrosis Hypoventilation Intercostal Retraction Lung Crepitation Oxygen Saturation Decreased Pallor Pulmonary Fibrosis Rales White Blood Cell Count Increased Report Source Product Role Foreign Study Health Professional Remicade (5 Mg/Ml Lyophilized Powder)(Infliximab, Recombinant) PS Vioxx (Rofecoxib) SS Methotrexate (Methotrexate) SS Lithium (Lithium) Mellaril(Thioridazin e Hydrochloride) Feldene(Piroxicam) Enconcor Dilutol(Torsemide) Karvia Isocover Pulmicort(Budesonide ) Atrovent(Ipratropium Bromide) Nitroderm(Glyceryl Trinitrate) Oxis (Formoterol) Date:06/25/02ISR Number: 3940024-1Report Type:Expedited (15-DaCompany Report #HQ294424JUN2002 Age:40 YR Gender:Male I/FU:I SS SS C C C C C C C C C Manufacturer Route Outcome Dose Other SEE IMAGE PT Report Source Product Role Liver Function Test Abnormal Health Professional Temesta (Lorazepam, Unspec) PS Quilonorm Retard (Lithium Carbonate, ) 65 SS Zyprexa (Olanzapine, ) SS DAY Weight Increased SEE IMAGE SEE IMAGE 10 5 DAY DAY Date:06/27/02ISR Number: 3940464-0Report Type:Expedited (15-DaCompany Report #D0038479A Age:53 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 440 Manufacturer Route Duration 10:48 AM PT Blood Creatine Phosphokinase Increased Diarrhoea Drug Level Above Therapeutic Drug Toxicity Fall Head Injury Intentional Misuse Muscle Spasms ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Staring Dose Report Source Product Role Manufacturer Route Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS ORAL Carbamazepine Tablet (Carbamazepine) SS ORAL Prothipendyl Hcl Tabelt (Prothipendyl Hcl) SS ORAL Duration 50 TABLET/ SINGLE DOSE/ ORAL 1 DAY 100 TABLET/SINGLE DOSE/ORAL 1 DAY 20 TABLET/SINGLE DOSE/ORAL 1 DAY Date:06/27/02ISR Number: 3940828-5Report Type:Direct Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Diarrhoea Drug Toxicity Vomiting Date:06/28/02ISR Number: 3941243-0Report Type:Direct Age:45 YR Gender:Male I/FU:I Company Report #CTU 171059 Report Source Product Role Lithium Estrogen Clonazepam Paxil Quetiapine Risperidol PS C C C C C Company Report #CTU 171228 Manufacturer Route Outcome Dose Duration Hospitalization 450MG BID Initial or Prolonged ORAL PT Report Source Disturbance In Attention Product Role Lithium Sr 450mg PS Manufacturer Route ORAL Fatigue Hypothyroidism Lethargy Date:07/03/02ISR Number: 3945029-2Report Type:Expedited (15-DaCompany Report #A211178 Age: Gender:Female I/FU:F Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Bipolar Disorder Fear Thinking Abnormal Consumer Zoloft Tablets Lithium (Manufacturer Unknown) Unspecified Psychiatric Medication PS Date:07/03/02ISR Number: 3945705-1Report Type:Expedited (15-DaCompany Report #D0038775A Age:29 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 441 10:48 AM PT Coordination Abnormal Drug Effect Decreased SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Interaction Speech Disorder Tongue Disorder Dose Report Source Product Role Manufacturer Route Foreign Health Professional Lithium Carbonate Tablet (Non-Us Product) PS ORAL Quetiapine Fumarate Tablet (Quetiapine Fumarate) SS ORAL Duration ORAL ORAL Imipramine Hydrochloride Lorazepam Ranitidine Hydrochloride Olanzapine C C C C Date:07/05/02ISR Number: 3945761-0Report Type:Expedited (15-DaCompany Report #EMADSS2001005486 Age:48 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Catatonia Dysphagia Neuroleptic Malignant Foreign Study Health Risperidone (Unspecified) (Risperidone) PS Syndrome Professional Topiramate (Capsule) (Topiramate) SS ORAL Placebo (Placebo) SS ORAL PATIENT HAD PREVIOUSLY Respiratory Failure RECEIVED RISPERIDONE FROM 3 CAP, DAILY, ORAL 3 CAP, DAILY, ORAL Lithium (Lithium) SS DAATE UNSPECIFIED Lorazepam (Lorazepam) Chloral Hydrate (Chloral Hydrate) Diazepam (Diazepam) Olanzapine (Olanzapine) Senna (Senna) Lactulose (Lactulose) Haloperidol (Haloperidol) Lithium Carbonate (Lithium Carbonate) Date:07/05/02ISR Number: 3946334-6Report Type:Expedited (15-DaCompany Report #A214139 Age: Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 442 10:48 AM PT Blood Creatine Phosphokinase Increased Blood Creatinine Increased Blood Glucose Increased Encephalopathy C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination, Auditory Hallucination, Visual Paranoia Dose Report Source Product Role Foreign Zoloft Tablets PS Lithium Valproic Acid Lasix Magnesium Allopurinol Tafil Stilnox SS C C C C C C Manufacturer Route Duration ORAL 100.00 MG Health TOTAL:DAILY:O Professional RAL Date:07/10/02ISR Number: 3946490-XReport Type:Direct Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600 MG BID Initial or Prolonged PT Company Report #CTU 171982 Report Source Abnormal Behaviour Product Role Lithium PS Manufacturer Route Manufacturer Route Speech Disorder Date:07/10/02ISR Number: 3947937-5Report Type:Expedited (15-DaCompany Report #2002000750 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Agitation Akinesia Anxiety Foreign Health Professional Atarax (Tablet) (Hydroxyzine Hydrochloride) PS ORAL 25 MG Caesarean Section (DAILY), ORAL Foetal Heart Rate Abnormal Maternal Drugs Affecting Lithium (Lithium) Chlorpromazine (Chlorpromazine) Foetus Clomipramine (DAILY), ORAL SS SS ORAL Neonatal Apnoeic Attack (Clomipramine) SS Pregnancy Psychomotor Hyperactivity Tachypnoea Tremor Neonatal Clonazepam (Clonazepam) C ORAL (DAILY), ORAL Date:07/10/02ISR Number: 3947994-6Report Type:Expedited (15-DaCompany Report #2002000749 Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other 25 MG Required (DAILY), ORAL Intervention to Prevent Permanent Impairment/Damage (DAILY), ORAL PT Report Source Product Role Caesarean Section Complications Of Maternal Exposure To Therapeutic Foreign Health Professional Atarax (Tablet) (Hydroxyzine Hydrochloride) PS 10:48 AM Route ORAL Drugs Foetal Arrhythmia Induced Labour Maternal Drugs Affecting Lithium (Lithium) Chlorpromazine (Chlorpromazine) Foetus Pregnancy Prolonged Labour SS SS ORAL Clomipramine (Clomipramine) SS ORAL Clonazepam (Clonazepam) C (DAILY), ORAL 22-Aug-2005 Page: 443 Manufacturer FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/02ISR Number: 3949723-9Report Type:Expedited (15-DaCompany Report #D0038587A Age:50 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 60 TABLET/ Other SINGLE DOSE/ Required ORAL Intervention to Prevent Permanent 27 TABLET / Impairment/Damage SINGLE DOSE/ PT Report Source Product Role Manufacturer Route Coma Haemodialysis Foreign Health Eskalith TabletControlled Release PS ORAL Intentional Misuse Professional Olanzapine Tablet (Olanzapine) SS ORAL Polyuria Somnolence Suicide Attempt ORAL Date:07/12/02ISR Number: 3948423-9Report Type:Expedited (15-DaCompany Report #A212025 Age:12 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other ORAL PT Report Source Product Role Aggression Condition Aggravated Drug Ineffective Health Professional Ziprasidone Eskalith (Lithium Carbonate) PS Excoriation Heart Rate Increased Heart Rate Irregular Irritability Clonidine (Clonidine) Manufacturer SS Route ORAL C Date:07/12/02ISR Number: 3950426-5Report Type:Expedited (15-DaCompany Report #D0038633A Age:35 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Agitation Dysarthria Enuresis Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Role Manufacturer Route Faecal Incontinence Carbonate) PS ORAL Olanzapine Tablet (Olanzapine) SS ORAL Citalopram Tablet (Citalopram) SS ORAL Thyroxine Sodium Tablet (Levothyroxine Sodium) SS ORAL Prothipendyl Hcl Tablet (Prothipendyl Hcl) SS ORAL 90 TABLET/ Haemodialysis SINGLE DOSE/ Intentional Misuse ORAL Somnolence Suicide Attempt 20 TABLET/ Vomiting SINGLE DOSE/ ORAL 20 TABLET/ SINGLE DOSE/ ORAL 50 TABLET/ SINGLE DOSE/ ORAL 10 TABLET/ SINGLE DOSE/ ORAL 22-Aug-2005 Page: 444 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/02ISR Number: 3951104-9Report Type:Expedited (15-DaCompany Report #001-0945-M0200710 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG PT Report Source Product Role Bipolar Disorder Consumer Neurontin (Gabapentin) PS Lithium (Lithium) SS Manufacturer Route Manufacturer Route (DAILY) 900 MG Date:07/23/02ISR Number: 3953553-1Report Type:Expedited (15-DaCompany Report #2002IC000229 Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged SUBCUTANEOUS PT Report Source Product Role Convulsion Study Librium 10mg PS Consumer Peg-Intron (Peginterferon Alfa-2b) SS Rebetol SS ORAL Lithium SS ORAL Klonopin C Dehydration Migraine Sleep Disorder 120 MCG; Vomiting ORAL WEEKLY; SUBCUTANEOUS 1000 MG; DAILY;ORAL ORAL Date:07/24/02ISR Number: 3953634-2Report Type:Expedited (15-DaCompany Report #2002000750 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Agitation Neonatal Akinesia Foreign Health Atarax (Tablet) (Hydroxyzine Role Manufacturer Route Anxiety Professional Hydrochloride) PS Foetal Cardiac Disorder Maternal Drugs Affecting Foetus Lithium (Lithium) Chlorpromazine (Chlorpromazine) SS Neonatal Apnoeic Attack Pregnancy Clomipramine (Clomipramine) Prolonged Labour Psychomotor Hyperactivity Somnolence Neonatal Transient Tachypnoea Of The Newborn Tremor Neonatal Clonazepam (Clonazepam) Heptaminol Hydrochloride ORAL 25 MG Apgar Score Low (DAILY), Caesarean Section ORAL SS ORAL SS ORAL (DAILY), ORAL (DAILY), ORAL C C Date:07/24/02ISR Number: 3955108-1Report Type:Expedited (15-DaCompany Report #2002-BP-03433RO (0) Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Convulsion Dehydration Migraine Study Consumer Health Lithium Carbonate Usp, 300 Mg (Lithium Carbonate) PS Usp ORAL Nausea Sleep Disorder Tremor Professional Other Librium (Chlordiazepoxide Hydrochloride) SS Peg-Intron (Peginterferon Alfa-2b) SS PO PO Vomiting SUBCUTANEOUS 120 MCG, WEEKLY, 22-Aug-2005 Page: 445 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report SUBCUTANEOUSL Y (1 IN 1 WK), SC Rebetol (Ribavirin) SS Klonopin (Clonazepam) C ORAL 1000 MG (1 IN 1 D), PO Date:07/24/02ISR Number: 3955959-3Report Type:Expedited (15-DaCompany Report #A0374148A Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Mania Overdose Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS Manufacturer Route Manufacturer Route Duration TWICE PER DAY Date:07/25/02ISR Number: 3954071-7Report Type:Expedited (15-DaCompany Report #A211114 Age:24 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening ORAL Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Blood Sodium Decreased Consumer Lithium (Lithium) PS ORAL Drug Level Increased Renal Failure Health Professional Prinivil (Lisinopril) SS ORAL Verapamil Prinzide (Prinzide) Zyprexa (Olanzapine) C C C Date:07/30/02ISR Number: 3956550-5Report Type:Expedited (15-DaCompany Report #LBID00202001804 Age:13 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Haematemesis Health Professional Lithobid (Lithium Carbonate) PS Manufacturer Route Duration ORAL 600 MG BID PO Date:07/31/02ISR Number: 3957252-1Report Type:Expedited (15-DaCompany Report #2002-BP-03500RO (0) Age:79 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 800 MG, QD, Initial or Prolonged PO PT Report Source Product Role Manufacturer Route Atherosclerosis Study Lithium Carbonate PS ORAL Mental Status Changes Health Triple Vessel Bypass Graft Professional Other Cgp 57148b (St1571/Cgp57148b T35717+Caps) Capsule SS ORAL 800 MG, QD, PO Date:08/01/02ISR Number: 3957958-4Report Type:Expedited (15-DaCompany Report #2002-DE-01604GD (0) Age:62 YR Gender:Male I/FU:I Outcome Dose Duration Other Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 446 10:48 AM PT Report Source Product Role Dialysis Renal Failure Chronic Foreign Study Literature Lithium Carbonate (Lithium Carbonate) PS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/02ISR Number: 3957960-2Report Type:Expedited (15-DaCompany Report #2002-DE-01603GD (0) Age:66 YR Gender:Female I/FU:I Outcome Dose Duration Other Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Dialysis Renal Failure Chronic Foreign Study Literature Lithium Carbonate (Lithium Carbonate) PS Manufacturer Route Manufacturer Route Manufacturer Route Manufacturer Route Date:08/01/02ISR Number: 3957961-4Report Type:Expedited (15-DaCompany Report #2002-DE-01601GD (0) Age:66 YR Gender:Female I/FU:I Outcome Dose Duration Other Required 19 YR Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Dialysis Renal Failure Chronic Foreign Study Lithium Carbonate (Lithium Carbonate) PS Literature Date:08/01/02ISR Number: 3957962-6Report Type:Expedited (15-DaCompany Report #2002-DE-01600GD (0) Age:76 YR Gender:Female I/FU:I Outcome Dose Duration Other Required 32 YR Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Dialysis Renal Failure Chronic Foreign Study Lithium Carbonate (Lithium Carbonate) PS Literature Date:08/01/02ISR Number: 3957966-3Report Type:Expedited (15-DaCompany Report #2002-DE-01597GD (0) Age:57 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Dialysis Foreign Lithium Carbonate Duration Role Required Intervention to Prevent Permanent Impairment/Damage Renal Failure Chronic Study Literature (Lithium Carbonate) PS Date:08/01/02ISR Number: 3958073-6Report Type:Expedited (15-DaCompany Report #2002-DE-01596GD (0) Age:71 YR Gender:Male I/FU:I Outcome Dose Duration Other Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Dialysis Renal Failure Chronic Foreign Study Literature Lithium Carbonate (Lithium Carbonate) PS Date:08/01/02ISR Number: 3958075-XReport Type:Expedited (15-DaCompany Report #2002-DE-01595GD (0) Age:78 YR Gender:Female I/FU:I Outcome Other Required Intervention to 22-Aug-2005 Page: 447 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage Dose PT Report Source Product Role Dialysis Renal Failure Chronic Foreign Study Literature Lithium Carbonate (Lithium Carbonate) PS Manufacturer Route Manufacturer Route Manufacturer Route Duration Date:08/01/02ISR Number: 3958565-XReport Type:Expedited (15-DaCompany Report #B0274494A Age:42 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Anorexia Bradycardia Bradyphrenia Depression Literature Health Professional Eskalith (Formulation Unknown) (Lithium Carbonate) PS Duration 1500 MG / PER Disturbance In Attention DAY Drug Ineffective Drug Interaction Drug Level Increased Fatigue Lethargy Medication Error Memory Impairment Nausea Neurotoxicity Nystagmus Tremor Weight Increased Topiramate (Formulation Unknown) (Topiramate) Wellbutrin (Formulation Unknown) (Bupropion Hydrochloride) Semisodium Valproate (Formulation Unknown) (Divalproex Sodium) Citalopram SS SS SS C Date:08/01/02ISR Number: 3958690-3Report Type:Expedited (15-DaCompany Report #D0038687A Age:70 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Encephalopathy Hypercalcaemia Hypernatraemia Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Role Hyperthyroidism Carbonate) PS Acetylcysteine Tramadol Hydrochloride Esomeprazole Moduretic C ORAL TWICE PER Pneumonia DAY/ ORAL Tremor C C C Date:08/02/02ISR Number: 3956996-5Report Type:Expedited (15-DaCompany Report #WAES 0207USA01759 Age:53 YR Gender:Female I/FU:F Outcome Dose Other 22-Aug-2005 Page: 448 PT Report Source Product Role Manufacturer Route Asthenia Difficulty In Walking Drug Interaction Gastrointestinal Disorder Mania Health Professional Vioxx Lithium Citrate Allegra Atenolol Klonopin Oxycontin Paxil Trazodone PS SS C C C C C C Merck & Co., Inc ORAL Duration 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/02ISR Number: 3957718-4Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Congenital Anomaly PT Company Report #CTU 173441 Report Source Craniosynostosis Maternal Drugs Affecting Foetus Neonatal Disorder Spinal Disorder Date:08/02/02ISR Number: 3961178-7Report Type:Periodic Age:49 YR Gender:Male I/FU:I Outcome Dose Other Product Role Lithium PS Manufacturer Route Manufacturer Route Company Report #NSADSS2002003734 PT Report Source Product Role Amnesia Convulsion Personality Disorder Consumer Risperdal (4 Mg Tablet) (Risperidone) PS ORAL Lithium (Lithium) SS ORAL Duration 4 MG, 2 IN 1 Purpura DAY(S), ORAL 300 MG, 3 IN 1 DAY(S), ORAL Prolixin (Fluphenazine Hydrochloride) Lopid (Gemfibrozil) Cogentin (Benzatropine Mesilate) C C C Date:08/05/02ISR Number: 3959038-0Report Type:Expedited (15-DaCompany Report #EPOS00302001860 Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 400 MG DAILY PT Report Source Product Role Bipolar Disorder Foreign Teveten (Eprosartan) PS Manufacturer Route ORAL Initial or Prolonged PO Diabetes Mellitus Study Drug Level Above Therapeutic Health Professional Dyskinesia Other Hypnorex Retard (Lithium Carbonate) SS ORAL 0.5 DF BID PO, DAILY PO Ass (Acetylsalicylic Acid) Sortis (Atorvastatin Calcium) C C Date:08/06/02ISR Number: 3959154-3Report Type:Expedited (15-DaCompany Report #EMADSS2001005486 Age:48 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Catatonia Dysphagia Foreign Study Risperidone (Risperidone) PS Headache Health Muscle Rigidity Professional Topiramate (Capsule) (Topiramate) SS ORAL Placebo (Placebo) SS ORAL Lithium (Lithium) SS PATIENT HAD PREVIOUSLY RECEIVED Neuroleptic Malignant RISPERIDONE Syndrome FROM Respiratory Failure 3 CAP, DAILY, ORAL 3 CAP, DAILY, ORAL 22-Aug-2005 Page: 449 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam (Lorazepam) Chloral Hydrate (Chloral Hydrate) Diazepam (Diazepam) Olanzapine (Olanzapine) Senna (Senna) Lactulose (Lactulose) Haloperidol (Haloperidol) Lithium Carbonate (Lithium Carbonate) C C C C C C C C Date:08/06/02ISR Number: 3959625-XReport Type:Expedited (15-DaCompany Report #A211114 Age:24 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening ORAL Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Drug Toxicity Consumer Lithium (Lithium) PS ORAL Haemodialysis Renal Failure Acute Health Professional Prinivil (Lisinopril) SS ORAL Verapamil Prinzide (Prinzide) Zyprexa (Olanzapine) C C C Urinary Tract Infection Manufacturer Route Date:08/06/02ISR Number: 3960209-8Report Type:Expedited (15-DaCompany Report #A209649 Age: Gender:Female I/FU:F Outcome Dose Other (TID), ORAL PT Report Source Product Role Manufacturer Route Confusional State Consumer Lithium (Lithium) PS ORAL Depression Dizziness Health Professional Gabapentin (Gabapentin) SS ORAL Prevacid (Lansoprazole) C Duration 300 MG Fatigue (DAILY), ORAL Nausea Osteoporosis Parkinson'S Disease Unknown Stool Softener (Laxative-S) Welbutrin Sr (Bupropion Hydrochloride) Propanolol C C C Date:08/07/02ISR Number: 3959393-1Report Type:Expedited (15-DaCompany Report #C2002-2188.01 Age:16 YR Gender:Male I/FU:I Outcome Dose Death 22-Aug-2005 Page: 450 PT Report Source Product Role Arrhythmia Drowning Drug Level Above Therapeutic Drug Toxicity Health Professional Pindolol Tablets Imipramine Tablets Chlorpromazine Lithium PS SS SS SS Duration 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/02ISR Number: 3960398-5Report Type:Expedited (15-DaCompany Report #B0274494A Age:42 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Anorexia Bradycardia Literature Health Eskalith (Lithium Carbonate) PS Bradyphrenia Professional Manufacturer Route Manufacturer Route Duration 1500 MG / PER DAY Depression Disturbance In Attention Drug Interaction Drug Level Increased Fatigue Lethargy Medication Error Memory Impairment Nausea Neurotoxicity Nystagmus Tremor Weight Decreased Weight Increased Topiramate (Topiramate) Wellbutrin (Bupropion Hydrochloride) Semisodium Valproate (Divalproex Sodium) Citalopram SS SS SS C Date:08/08/02ISR Number: 3960886-1Report Type:Expedited (15-DaCompany Report #200216336GDDC Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization PO Initial or Prolonged PO Disability PT Report Source Product Role Diarrhoea Foreign Metronidazole PS ORAL Drug Interaction Other Lithium SS ORAL Amlodipine Besilate (Istin) Bismuth Amoxicillin Omeprazole C C C C Hyperhidrosis Hypertension Somnolence Vomiting Date:08/08/02ISR Number: 3960925-8Report Type:Expedited (15-DaCompany Report #HQ3226315JUL2002 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Leukocytosis Lower Respiratory Tract Infection Health Professional Efexor Xr (Venlafaxine Hydrochloride, Capsule, Extended Release) PS ORAL Lithium (Lithium, ) SS ORAL 75 MG 1X PER 1 DAY ORAL Date:08/09/02ISR Number: 3962020-0Report Type:Expedited (15-DaCompany Report #A211114 Age:24 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening ORAL Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Blood Sodium Decreased Consumer Lithium (Lithium) PS ORAL Haemodialysis Renal Failure Acute Health Professional Prinivil (Lisinopril) SS ORAL Verapamil Prinzide (Prinzide) Zyprexa (Olanzapine) C C C Therapeutic Agent Toxicity Urinary Tract Infection 22-Aug-2005 Page: 451 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/02ISR Number: 3961544-XReport Type:Expedited (15-DaCompany Report #2002002891 Age:42 YR Gender:Female I/FU:I Outcome Dose Other UNKNOWN PT Report Source Product Role Convulsion Consumer Lithium PS Librium (Chlordiazeoxide) SS Rebetol (Rivavirin) SS Peg-Intron (Peginterferon Alfa-2b) SS Manufacturer Route Manufacturer Route Duration Dehydration (UNKNOWN), Migraine UNKNOWN Nausea Sleep Disorder UNKNOWN Tremor (UNKNOWN), Vomiting UNKNOWN UNKNOWN (UNKNOWN), UNKNOWN UNKNOWN (UNKNOWN), UNKNOWN Date:08/15/02ISR Number: 3963683-6Report Type:Expedited (15-DaCompany Report #D0039066A Age:71 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Diarrhoea Haemodialysis Intentional Misuse Suicide Attempt Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS 10 Vomiting TABLET/SINGLE ORAL DOSE/ORAL Date:08/16/02ISR Number: 3964263-9Report Type:Expedited (15-DaCompany Report #A0367112A Age:36 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged UNK PT Report Source Product Role Abdominal Distension Abdominal Pain Upper Asthenia Fatigue Health Professional Lithium Salt (Formulation Unknown) (Generic) (Lithium Salt) PS Multiple Medication (Formulation Unknown) (Multiple Medication) SS Manufacturer Route ORAL / PER Gastrointestinal Disorder DAY / ORAL Gastrointestinal Ulcer Inflammation Muscle Disorder Myalgia Nausea Overdose Date:08/17/02ISR Number: 3963348-0Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 600 MG PO TID Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 452 10:48 AM PT Company Report #CTU 174404 Report Source Product Role Drug Toxicity Lithium PS Fall Hypoglycaemia Zoloft Artane Benedryl Trifluoperazine Insalen C C C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/19/02ISR Number: 3964179-8Report Type:Direct Age:37 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 80MG BID Initial or Prolonged ORAL PT Company Report #CTU 174515 Report Source Muscle Rigidity Product Role Manufacturer Route Geodon Pfizer , Inc PS Pfizer, Inc ORAL Lithium SS Depakote Klonopin Cogentin Propranolol Amaryl Levoxyl Copaxone Gluophage C C C C C C C C ORAL 600MG BID ORAL Date:08/19/02ISR Number: 3964796-5Report Type:Expedited (15-DaCompany Report #B0275800A Age:49 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Diarrhoea Drug Interaction Hyperhidrosis Hypertension Foreign Lithium Salt (Formulation Unknown) (Lithium Salt) PS ORAL Metronidazole (Formulation Unknown) (Metronidazole) SS ORAL ORAL Somnolence Vomiting ORAL Amlodipine Besylate Bismuth Salt Amoxicillin Trihydrate Omeprazole Statins C C C C C Date:08/19/02ISR Number: 3964922-8Report Type:Expedited (15-DaCompany Report #D0038687A Age:70 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Cholelithiasis Condition Aggravated Encephalopathy Hypercalcaemia Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS TWICE PER DAY Hypernatraemia / ORAL ; Hyperparathyroidism SEE TEXT Hyperthyroidism Nephrogenic Diabetes Insipidus Pneumonia Pseudomonas Infection Psoriasis Sepsis Tremor 22-Aug-2005 Page: 453 10:48 AM Acetylcysteine Tramadol Hydrochloride Esomeprazole Moduretic C C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/02ISR Number: 3965141-1Report Type:Expedited (15-DaCompany Report #001-0981-M0200681 Age: Gender:Male I/FU:F Outcome Dose Duration Other Required 10 MG Intervention to (DAILY), ORAL Prevent Permanent Impairment/Damage PT Report Source Product Role Bipolar I Disorder Bladder Disorder Consumer Health Atorvastatin (Atorvastatin) PS Cataract Professional Gabapentin Lithium Carbonate SS SS Oedema Peripheral Pollakiuria Renal Disorder Sepsis Weight Increased Manufacturer Route ORAL Date:08/20/02ISR Number: 3965632-3Report Type:Expedited (15-DaCompany Report #EMADSS2001005486 Age:48 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Drug Ineffective Neuroleptic Malignant Syndrome Foreign Study Health Risperidone (Unspecified) (Risperidone) PS Respiratory Failure Professional Topiramate (Capsule) (Topiramate) SS ORAL Placebo (Placebo) SS ORAL Lithium (Lithium) Lorazepam (Lorazepam) SS PATIENT HAD PREVIOUSLY RECEIVED RISPERIDONE FROM 3 CAP DAILY, ORAL 3 CAP, DAILY, ORAL C Chloral Hydrate (Chloral Hydrate) Diazepam (Diazepam) Olanzapine (Olanzapine) Senna (Senna) Lactulose (Lactulose) Haloperidol (Haloperidol) Lithium Carbonate (Lithium Carbonate) C C C C C C C Date:08/23/02ISR Number: 3967179-7Report Type:Expedited (15-DaCompany Report #2002003870 Age:44 YR Gender:Male I/FU:I Outcome Dose Disability ORAL PT Report Source Product Role Akathisia Health Lithium PS ORAL Professional Ziprasidone SS ORAL Verapamil Synthroid (Levothyroxine Sodium) C 40 MG (BID), ORAL 22-Aug-2005 Page: 454 Manufacturer Route Duration 10:48 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/02ISR Number: 3967487-XReport Type:Direct Age:39 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300MG PO BID Initial or Prolonged 45MG QD PT Company Report #CTU 175056 Report Source Coma Product Role Lithium 300mg PS Phenelzine 45mg SS Olanzapine Trazadone C C Manufacturer Route ORAL Date:08/27/02ISR Number: 3968292-0Report Type:Expedited (15-DaCompany Report #B0277136A Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged UNKNOWN UNKNOWN UNKNOWN PT Asthenia Cerebral Atrophy Drug Interaction Electroencephalogram UNKNOWN Abnormal Fall Muscle Twitching Tremor UNKNOWN 10 DAY Report Source Product Role Foreign Literature Health Professional Eskalith (Formulation Unknown) (Lithium Carbonate) PS Carbamazepine (Formulation Unknown) (Carbamazepine) SS Clozapine (Formulation Unknown) (Clozapine) SS Manufacturer Route Manufacturer Route UNKNOWN Date:08/27/02ISR Number: 3968293-2Report Type:Expedited (15-DaCompany Report #B0276937A Age:21 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Aggression Alanine Aminotransferase Increased Drug Interaction Red Blood Cell Count Increased Foreign Literature Health Professional Eskalith (Formulation Unknown) (Lithium Carbonate) Carbamazepine (Formulation Role PS Tremor UNKNOWN UNKNOWN 13 Unknown) (Carbamazepine) SS Clozapine (Formulation Unknown) (Clozapine) SS DAY UNKNOWN Date:08/27/02ISR Number: 3968313-5Report Type:Expedited (15-DaCompany Report #EMADSS2002004997 Age:46 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Agitation Blood Creatine Foreign Health Haldol (Unspecified) (Haloperidol) PS Phosphokinase Increased Dystonia Overdose Professional Lithium Carbonate (Lithium Carbonate) Risperidone (Risperidone) Fluoxetine (Fluoxetine) Depot Provera (Medroxyprogesterone Acetate) Clonazepam (Clonazepam) Duration 5 MG, 22-Aug-2005 Page: 455 10:48 AM SS C C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/02ISR Number: 3968326-3Report Type:Expedited (15-DaCompany Report #EPOS00302001860 Age:53 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 400 MG DAILY Initial or Prolonged PO PT Report Source Product Role Manufacturer Route Bipolar Disorder Foreign Teveten (Eprosartan) PS ORAL Cerebellar Syndrome Study Diabetes Mellitus Drug Level Above Health Professional Hypnorex Retard (Lithium Carabonate) SS ORAL Therapeutic Other 0.5 DF BID PO, DAILY PO Dyskinesia Extensor Plantar Response Hemiparesis Hypertension Movement Disorder Neurological Examination Abnormal Ass (Acetylsalicylic Acid) Sortis (Atorvastatin Calcium) C C Date:08/27/02ISR Number: 3969192-2Report Type:Expedited (15-DaCompany Report #A0377880A Age:41 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required UNK / SEE Intervention to DOSAGE TEXT / Prevent Permanent ORAL Impairment/Damage PT Report Source Product Role Manufacturer Route Disturbance In Attention Drug Level Increased Dyspepsia Health Professional Eskalith Tablet -Controlled Release (Lithium Carbonate) PS ORAL Psychomotor Hyperactivity Restlessness Somnolence Speech Disorder Staring Buspirone Hydrochloride (Formulation Unknown) Buspirone Hydrochloride) SS ORAL Vomiting Olanzapine (Formulation Unknown)Olanzapine) SS ORAL Muscle Rigidity Overdose ORAL ORAL Risperidone (Formulation Unknown)Risperidone) SS ORAL Benztropine Mesylate (Formulation Unknown)(Benztropine Mesylate) SS ORAL Thyroxine Sodium (Formulation Unknown) Levothyroxine Sodium) SS ORAL ORAL ORAL ORAL Date:08/27/02ISR Number: 3969232-0Report Type:Expedited (15-DaCompany Report #B0277028A Age:52 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 456 10:48 AM PT Anxiety Bipolar Disorder Blood Creatinine Increased Blood Urea Increased Condition Aggravated Nervousness Sinus Tachycardia Thyroiditis FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Upper Respiratory Tract Infection Weight Decreased Dose 15 Report Source Product Role Literature Health Lithium Salt (Lithium Salt) PS Professional Olanzapine Simvastatin Valproic Acid Aspirin C C C C Manufacturer Route Manufacturer Route Duration YR Date:08/27/02ISR Number: 3969234-4Report Type:Expedited (15-DaCompany Report #B0258321A Age:45 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Anxiety Convulsion Literature Health Lithium Salt (Lithium Salt) PS ORAL Depression Professional Lithium Salt (Lithium Salt) SS ORAL Lithium Salt (Lithium Salt) SS ORAL Duration 300 MG / TWICE PER DAY Drug Ineffective / ORAL 1 DAY Insomnia ORAL 3 DAY ORAL Bupropion Hydrochloride Venlafaxine Hydrochloride Gabapentin Clonazepam Glycopyrronium Bromide Methohexitone Suxamethonium Date:08/29/02ISR Number: 3969294-0Report Type:Expedited (15-DaCompany Report #2002004395 Age: Gender: I/FU:I C C C C C C C Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Serotonin Syndrome Literature Consumer Lithium (Lithium) Fluoxetine (Fluoxetine) PS Manufacturer Route Manufacturer Route SS Date:08/30/02ISR Number: 3969440-9Report Type:Expedited (15-DaCompany Report #2002003870 Age:44 YR Gender:Male I/FU:F Outcome Dose Disability ORAL PT Report Source Product Role Akathisia Health Lithium PS ORAL Drug Interaction Professional Ziprasidone SS ORAL Verapamil Synthroid (Levothyroxine Sodium) C Duration 60 MG Dyskinesia (DAILY), ORAL 22-Aug-2005 Page: 457 10:48 AM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/02ISR Number: 3970209-XReport Type:Expedited (15-DaCompany Report #2002004291 Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG, ORAL Disability 800 MG PT Report Source Product Role Bipolar Disorder Foreign Health Cetirizine (Tablets) (Cetirizine) PS Professional Lithium (Lithium) SS Manufacturer Route ORAL Date:09/03/02ISR Number: 3972923-9Report Type:Expedited (15-DaCompany Report #B0277651A Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Coma Haemodialysis Pancreatitis Acute Foreign Augmentin Tablet (Amox.Trihyd+Pot.Cla vulan.) PS ORAL Lithium Carbonate Tablet (Non-Us Product) SS ORAL Bromazepam Tablet (Bromazepam) SS ORAL Paxil Tablet (Paroxetine Hydrochloride) SS ORAL ORAL Suicide Attempt ORAL ORAL ORAL Date:09/04/02ISR Number: 3970456-7Report Type:Direct Age:62 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG TI Initial or Prolonged Required Intervention to Prevent Permanent PT Company Report #CTU 175626 Report Source Product Role Laboratory Test Abnormal Lithium PS Lethargy Mental Status Changes Benztropine Diphenhydramine Fluphenazine Thiamine C C C C Manufacturer Route Impairment/Damage Folic Acid C Date:09/04/02ISR Number: 3971562-3Report Type:Expedited (15-DaCompany Report #2002-BP-04158RO(0) Age:79 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Atherosclerosis Confusional State Drug Toxicity Study Health Professional Lithium Carbonate Capsules Usp, 300 Mg (Lithium Carbonate) PS Enterococcal Infection Lung Disorder Urinary Tract Infection Other Gleevec (Code Not Broken) SS PO Date:09/04/02ISR Number: 3971566-0Report Type:Expedited (15-DaCompany Report #9409995 Age:16 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 458 10:48 AM PT Anorexia Bipolar Disorder Depression Hallucination Heart Rate Increased Overdose Psychotic Disorder Respiratory Rate Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Suicide Attempt Dose Report Source Product Role Health Zoloft (Sertraline) PS Lithium Depakote (Valproate Semisodium) Remeron (Mirtazapine) Tylenol (Paracetamol) Advil (Ibuprofen) All Other Therapeutic Products SS Manufacturer Route Duration ORAL 200 MG Professional (DAILY), ORAL Date:09/05/02ISR Number: 3970853-XReport Type:Direct Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Required 300MG TID Intervention to ORAL Prevent Permanent 0.375MG QD Impairment/Damage ORAL PT SS SS C C C Company Report #CTU 175744 Report Source Blood Thyroid Stimulating Product Role Manufacturer Route Lithium 300mg PS ORAL Levothroxine .125mg SS ORAL Hormone Increased Chronic Obstructive Airways Disease Exacerbated Drug Level Above Therapeutic Tremor Date:09/05/02ISR Number: 3972744-7Report Type:Expedited (15-DaCompany Report #2002003870 Age:44 YR Gender:Male I/FU:F Outcome Dose PT Duration Report Source Product Role Manufacturer Route Other ORAL Akathisia Health Lithium PS ORAL Formication Professional Ziprasidone SS ORAL 120 MG (BID), Insomnia ORAL Lethargy Mellaril (Thioridazine Hydrochloride) Zyprexa (Olanzapine) Verapamil Synthroid (Levothyroxine Sodium) SS SS C C Date:09/05/02ISR Number: 3972802-7Report Type:Expedited (15-DaCompany Report #2002002891 Age:42 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Convulsion Consumer Lithium PS ORAL Dehydration Migraine Librium (Chlordiazepoxide) SS ORAL Nausea Rebetol (Ribabirin) SS ORAL Manufacturer Route ORAL 1000 Sleep Disorder MG(DAILY), Tremor ORAL Vomiting 22-Aug-2005 Page: 459 10:48 AM Peg-Introl (Peginterferon FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report SUBCUTANEOUS Alfa-2b) SS Clonazepam C 120 MCG(WEEKLY), SUBCUTANEOUS Date:09/06/02ISR Number: 3972655-7Report Type:Expedited (15-DaCompany Report #B0277530A Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Blood Pressure Increased Coordination Abnormal Depression Drug Toxicity Literature Health Professional Eskalith (Formulation Unknown) (Lithium Carbonate) PS Manufacturer Route Manufacturer Route 600 MG/TWICE Dysarthria PER DAY Hyperthyroidism Polyuria Sinus Tachycardia Therapeutic Agent Toxicity Thyroiditis Tremor Date:09/06/02ISR Number: 3972661-2Report Type:Expedited (15-DaCompany Report #A0374148A Age: Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Mania Overdose Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS Duration TWICE PER DAY Date:09/09/02ISR Number: 3973797-2Report Type:Expedited (15-DaCompany Report #HQ3226315JUL2002 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Leukocytosis Pneumonia Health Professional Efexor Xr (Venlafaxine Hydrochloride, Capsule, Extended Release) PS ORAL Lithium (Lithium, ) SS ORAL 75 MG 1X PER 1 DAY Date:09/09/02ISR Number: 3974518-XReport Type:Direct Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Company Report #CTU 175987 Report Source Drug Toxicity Dysarthria Mental Status Changes Product Role Lithium PS Date:09/10/02ISR Number: 3973846-1Report Type:Expedited (15-DaCompany Report #B0277878A Age:26 YR Gender:Female I/FU:I Outcome Other 22-Aug-2005 Page: 460 PT Hyperthyroidism 10:48 AM Report Source Foreign Literature Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Dose Product Role Eskalith (Formulation Unknown) (Lithium Carbonate) PS Manufacturer Route Manufacturer Route Duration PER DAY Date:09/10/02ISR Number: 4000916-4Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #2002114176US PT Report Source Product Role Delirium Drug Interaction Consumer Bextra (Valdecoxib) Tablet PS Duration ORAL 20 MG QD, ORAL 10 DAY Lithium (Lithium) Itraconazole (Itraconazole) SS SS Date:09/12/02ISR Number: 3975243-1Report Type:Expedited (15-DaCompany Report #2002003870 Age:44 YR Gender:Male I/FU:F Outcome Dose Other 900 MG PT Report Source Product Role Manufacturer Route Akathisia Health Lithium PS ORAL Drug Interaction Professional Geodon (Ziprasidone) SS ORAL Duration (DAILY), ORAL Feeling Abnormal 1`20 MG Insomnia (BID), ORAL Lethargy Mellaril (Thiridazine Hydrochloride) Zyprexa (Olanzapine) Verapamil Synthroid SS SS C (Levothyroxine Sodium) Date:09/13/02ISR Number: 3975712-4Report Type:Direct Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG Q8 Initial or Prolonged PT C Company Report #CTU 176374 Report Source Asthenia Product Role Lithium Carbonate PS Manufacturer Route Manufacturer Route Confusional State Drug Level Increased Renal Failure Acute Date:09/13/02ISR Number: 3976218-9Report Type:Expedited (15-DaCompany Report #D0039220A Age:27 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Intentional Misuse Somnolence Suicide Attempt Foreign Health Professional Lithium Carbonate Tablet (Non-Us Product) PS ORAL Gelonida Tablet (Gelonida) SS ORAL 450 MG/ SINGLE DOSE / ORAL 500 MG/ SINGLE DOSE / 22-Aug-2005 Page: 461 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:09/16/02ISR Number: 3977258-6Report Type:Direct Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG BID Initial or Prolonged PT PT PT Product Role Lithium PS Cipro Ferrous Sulfate Multivitamins Temazepam C C C C Manufacturer Route Manufacturer Route Manufacturer Route Company Report #CTU 176563 Report Source Mental Status Changes Date:09/18/02ISR Number: 3977596-7Report Type:Direct Age:36 YR Gender:Male I/FU:I Outcome Dose Other Report Source Renal Failure Acute Date:09/16/02ISR Number: 3977288-4Report Type:Direct Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG TID Initial or Prolonged Company Report #CTU 176527 Product Role Lithium PS Temazepam Risperidone Terazosin Hctz C C C C Company Report #CTU 176804 Report Source Product Role Lithium Carbonate 300mg PS Haloperidol Divalproex Propranolol C C C Duration Renal Impairment 600MG PO BID ORAL Date:09/18/02ISR Number: 3980009-2Report Type:Expedited (15-DaCompany Report #2002-BP-04158BRO Age:79 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization PO Initial or Prolonged PT Report Source Product Role Manufacturer Route Confusional State Study Lithium Carbonate PS Usp ORAL Coronary Artery Surgery Enterococcal Infection Lung Disorder Mental Status Changes Urinary Tract Infection Health Professional Other Gleevec (Code Not Broken) SS Manufacturer Route Date:09/19/02ISR Number: 3977726-7Report Type:Expedited (15-DaCompany Report #B0279406A Age:39 YR Gender: I/FU:I Outcome Dose Death 22-Aug-2005 Page: 462 PT Report Source Product Drug Level Increased Medication Error Literature Health Professional Lithium Salt (Lithium Salt) Paracetamol (Acetaminophen) Role Duration 10:48 AM PS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/19/02ISR Number: 3977778-4Report Type:Expedited (15-DaCompany Report #B0279405A Age:44 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Alcohol Poisoning Completed Suicide Literature Health Ethanol (Formulation Unknown) (Alcohol) PS ORAL Intentional Misuse Professional Trazodone (Formulation Unknown) (Trazodone) SS ORAL Lithium Salt (Formulation Unknown) (Lithium Salt) SS ORAL Duration ORAL ORAL ORAL Date:09/19/02ISR Number: 3978187-4Report Type:Expedited (15-DaCompany Report #B0279388A Age:45 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Drug Level Increased Medication Error Literature Health Professional Lithium Salt (Formulation Unknown) (Lithium Salt) PS Manufacturer Route Duration ORAL ORAL Date:09/19/02ISR Number: 3978189-8Report Type:Expedited (15-DaCompany Report #B0279389A Age:50 YR Gender: I/FU:I Outcome Dose Death ORAL PT Report Source Product Role Drug Level Above Therapeutic Medication Error Literature Health Professional Lithium Salt (Formulation Unknown) (Lithium Salt) PS Manufacturer Route Duration ORAL Date:09/19/02ISR Number: 3978192-8Report Type:Expedited (15-DaCompany Report #B0279390A Age:41 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Completed Suicide Intentional Misuse Literature Health Professional Lithium Salt (Formulation Unknown) (Lithium Salt) PS ORAL Haloperidol (Formulation Unknown) (Haloperidol) SS ORAL Duration ORAL ORAL Date:09/19/02ISR Number: 3978196-5Report Type:Expedited (15-DaCompany Report #B0279432A Age:40 YR Gender: I/FU:I Outcome Dose Death 22-Aug-2005 Page: 463 PT Report Source Product Role Completed Suicide Intentional Misuse Literature Health Professional Lithium Salt (Formulation Unknown) (Lithium Salt) Thyroxine Sodium Frusemide PS C C Duration 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/19/02ISR Number: 3978200-4Report Type:Expedited (15-DaCompany Report #B0279433A Age:34 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Cardio-Respiratory Arrest Completed Suicide Intentional Misuse Literature Health Professional Lithium Salt (Formulation Unknown) (Lithium Salt) Opiate Benzodiazepines PS C C Manufacturer Route Manufacturer Route Manufacturer Route Duration Date:09/19/02ISR Number: 3978203-XReport Type:Expedited (15-DaCompany Report #B0279434A Age:80 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Intentional Misuse Literature Health Professional Lithium Salt (Formulation Unknown) (Lithium Salt) Temazepam PS C Duration Date:09/19/02ISR Number: 3978205-3Report Type:Expedited (15-DaCompany Report #B0279666A Age:26 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Unevaluable Event Literature Health Professional Lithium Salt (Formulation Unknown) PS Olanzapine (Formulation Unknown) (Olanzapine) SS Duration ORAL Date:09/19/02ISR Number: 3978207-7Report Type:Expedited (15-DaCompany Report #B0279407A Age:44 YR Gender: I/FU:I ORAL Outcome Dose Death PT Report Source Product Drug Level Increased Literature Health Professional Paracetamol (Formulation Unknown) (Acetaminophen) Lithium Salt (Formulation Unknown) (Lithium Salt) Role Manufacturer Route Manufacturer Route Duration PS SS Date:09/19/02ISR Number: 3978269-7Report Type:Expedited (15-DaCompany Report #A0380038A Age:16 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Drug Interaction Drug Toxicity Pharyngitis Streptococcal Health Professional Eskalith (Formulation Unknown) (Lithium Carbonate) PS Phenoxymethylpenicil lin Potassium (Penicillin V Potassium) SS ORAL 22-Aug-2005 Page: 464 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/19/02ISR Number: 3978323-XReport Type:Expedited (15-DaCompany Report #B0279371A Age:55 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Completed Suicide Intentional Misuse Literature Health Lithium Salt (Lithium Salt) PS ORAL Professional Fluphenazine (Fluphenazine) SS ORAL Quetiapine (Quetiapine) SS ORAL Duration ORAL ORAL ORAL Date:09/20/02ISR Number: 3979523-5Report Type:Expedited (15-DaCompany Report #2002057061 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Confusional State Difficulty In Walking Consumer Dilantin (Phenytoin Sodium) PS ORAL Drug Toxicity Lithium SS ORAL Dyskinesia Valproate Semisodium SS ORAL Duration 400 MG Drug Interaction (DAILY), ORAL ORAL ORAL Insomnia Mood Altered Speech Disorder Tremor Weight Decreased Date:09/23/02ISR Number: 3979591-0Report Type:Expedited (15-DaCompany Report #LBID00202002284 Age:32 YR Gender:Male I/FU:I Outcome Dose Other DAILY PO PT Report Source Product Role Balance Disorder Confusional State Consumer Lithobid (Lithium Carbonate) PS Manufacturer Route Duration ORAL Disturbance In Attention Muscle Twitching Suicide Attempt Vomiting Date:09/24/02ISR Number: 3980954-8Report Type:Expedited (15-DaCompany Report #D0039220A Age:27 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Intentional Misuse Somnolence Suicide Attempt Foreign Health Professional Lithium Carbonate Tablet (Non-Us Product) PS ORAL Gelonida Tablet (Gelonida) SS ORAL 450 MG, SINGLE DOSE; ORAL 500 MG, SINGLE DOSE; ORAL Date:09/25/02ISR Number: 3982309-9Report Type:Expedited (15-DaCompany Report #B0279668A Age: Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 465 10:48 AM PT Drug Level Decreased Haemodialysis Neuroleptic Malignant FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Pancreatitis Dose 2 Report Source Product Role Literature Health Professional Ziprasidone Hcl (Ziprasidone Hcl) (Formulation Unknown) PS Lithium Salt (Lithium Salt) (Formulation Unknown) SS Clozapine (Clozapine) (Formulation Unknown) SS Manufacturer Route Manufacturer Route Duration WK YR YR Date:09/27/02ISR Number: 3981743-0Report Type:Expedited (15-DaCompany Report #D0039066A Age:71 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Diarrhoea Haemodialysis Intentional Misuse Nausea Foreign Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS ORAL 10 Suicide Attempt TABLET/SINGLE Vomiting DOSE/ORAL Date:09/27/02ISR Number: 3982696-1Report Type:Direct Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required PT Nephrogenic Diabetes Insipidus Company Report #CTU 177460 Report Source Product Role Lithium Carbonate Tablets Quetapine Fumarate PS C Manufacturer Route Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 466 10:48 AM Etodolac Sildenapril Citrate Aspirin Multivitamin/Mineral s Metformin Hcl Furosemide Felodipine Cyclobenzaprine Hcl Minocycline Hcl Glipizide Rantidine Hcl Clotrimazole Guaifensin Albuterol 90/Ipratrop Oxycodone 5mg/Acetaminophen C C C C C C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/02ISR Number: 3982878-9Report Type:Expedited (15-DaCompany Report #NSADSS2002033048 Age:9 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Diabetes Insipidus Consumer Topamax (Tablet) (Topiramate) PS Lithobid (Lithium Carbonate) Zyprexa (Olanzapine) .. SS C C Manufacturer Route Manufacturer Route Manufacturer Route Duration SEE IMAGE Date:10/01/02ISR Number: 3986093-4Report Type:Expedited (15-DaCompany Report #2001AP05204 Age:55 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Drug Toxicity Literature Health Professional Quetiapine Fluphenazine Lithium PS SS SS Duration Date:10/01/02ISR Number: 4027317-7Report Type:Periodic Age:24 YR Gender:Female I/FU:I Outcome Dose Duration Required 400 MG QAM PO Intervention to 1600 MG HS PO Prevent Permanent 5 MG BID PO Impairment/Damage 600 MG QAM PO Company Report #2001UW07551 PT Report Source Product Role Drooling Health Seroquel "Zeneca" PS ORAL Neuroleptic Malignant Professional Seroquel "Zeneca" SS ORAL Haldol SS ORAL Lithium SS ORAL Lithium SS ORAL Propranolol C Syndrome 300 MG HS PO Date:10/02/02ISR Number: 3983158-8Report Type:Expedited (15-DaCompany Report #WAES 0205USA01719 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Coma Dysarthria Oedema Peripheral Paraesthesia Health Professional Vioxx Lithium Carbonate Paxil Glucophage Glucotrol Prilosec Lipitor Metamucil [Therapy Unspecified] PS SS SS C C C C C Merck & Co., Inc ORAL C Date:10/02/02ISR Number: 3983231-4Report Type:Expedited (15-DaCompany Report #WAES 0204SWE00002 Age:81 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 25 DAY Initial or Prolonged 22-Aug-2005 Page: 467 10:48 AM PT Report Source Product Role Manufacturer Route Blood Creatinine Health Vioxx PS Merck & Co., Inc ORAL Increased Depressed Level Of Consciousness Drug Level Increased Extrapyramidal Disorder Professional Lithium Sulfate Levothyroxine Sodium Dipyridamole Lofepramine Hydrochloride Zolpidem Tartrate Calcium Carbonate And Cholecalciferol SS C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tramadol Hydrochloride Date:10/02/02ISR Number: 3983817-7Report Type:Direct Age:56 YR Gender:Male I/FU:I Outcome Dose Other 500 MG QD PT C Company Report #CTU 177820 Report Source Product Role Lithium PS Manufacturer Route Manufacturer Route Duration Nephrogenic Diabetes Insipidus Post Procedural Complication Date:10/02/02ISR Number: 3985468-7Report Type:Direct Age:44 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200MG, 600MG Initial or Prolonged BI ORAL Required Intervention to Prevent Permanent Impairment/Damage PT Company Report #CTU 177745 Report Source Drug Level Above Product Role Lithium PS Lithium Carbonate Quetiapine Fumarate Clonazepam Glyburide 2.5mg/Metformin Hcl Ibuprofen Hydroxyzine Pamoate C C C C ORAL Therapeutic C C C Date:10/03/02ISR Number: 3986956-XReport Type:Expedited (15-DaCompany Report #2002058798 Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Coordination Abnormal Health Lithane (Lithium) PS Dysarthria Motor Dysfunction Professional Risperidone Trifluoperazine SS Manufacturer Route ORAL Overdose Somnolence Hydrochloride Carbamazepine Olanzapine C C C Date:10/03/02ISR Number: 3987084-XReport Type:Expedited (15-DaCompany Report #2002125973AU Age:64 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 200 MG, BID, PT Report Source Product Role Blood Creatinine Increased Foreign Literature Celebrex (Celecoxib) Capsule PS Confusional State Health Dehydration Professional Lithium (Lithium) SS Drug Interaction Other Risperidone Venlafaxine C C ORAL 250 MG MANE, 500 MG NOCTE, Drug Level Above Therapeutic Gait Disturbance Nystagmus Thirst Tremor 22-Aug-2005 Page: 468 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/02ISR Number: 3986901-7Report Type:Expedited (15-DaCompany Report #LBID00202002402 Age:32 YR Gender:Male I/FU:I Outcome Dose Disability PT Report Source Product Role Blindness Transient Deafness Unilateral Consumer Lithobid (Lithium Carbonate) PS Risperdal (Risperidone) C Manufacturer Route Duration ORAL 300 & 600 MG Diarrhoea DAILY PO, Ear Pain Migraine Tinnitus Vision Blurred Date:10/08/02ISR Number: 3989985-5Report Type:Expedited (15-DaCompany Report #EPOS00302001860 Age:53 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 400 MG DAILY Initial or Prolonged PO PT Report Source Product Role Manufacturer Route Drug Level Increased Foreign Teveten (Eprosartan) PS ORAL Dyskinesia Study Hemiparesis Hypertension Health Professional Hypnorex Retard (Lithium Carbonate) SS ORAL 1 DF BID PO, Other UNK DAILY PO Ass (Acetylsalicylic Acid) Sortis (Atorvastatin Calcium) Glucobay 50 Metfogamma 850 (Metformin) C C C C Date:10/08/02ISR Number: 3990112-9Report Type:Expedited (15-DaCompany Report #B0280507A Age:29 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization - PT Report Source Product Mouth Ulceration Foreign Lithium Acetate Role Manufacturer Route Initial or Prolonged Health Professional Tablet (Lithium Acetate) PS ORAL Lamictal Unspecified Tablet (Lamotrigine) SS ORAL Risperidone Reboxetine Diane-35 C C C ORAL SEE DOSAGE TEXT / ORAL Date:10/09/02ISR Number: 3987182-0Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Required 600MG PO BID Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 469 10:48 AM PT Company Report #CTU Report Source 178381 Product Role Blood Creatinine Lithium Carbonate PS Increased Blood Urea Increased Confusional State Dysarthria Lethargy Sedation Lisinopril Rispeeridone Niccoderm Patch Insulin SS C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/09/02ISR Number: 3987558-1Report Type:Direct Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200MG,600 MG Initial or Prolonged BID ORAL PT Report Source Drug Toxicity Date:10/09/02ISR Number: 3988241-9Report Type:Direct Age:69 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Company Report #CTU 178368 PT Product Role Lithium PS Spironolactone Furosemide C C Manufacturer Route ORAL Company Report #CTU 178292 Report Source Drug Level Above Therapeutic Product Role Lithium PS Manufacturer Route Manufacturer Route Date:10/09/02ISR Number: 3990829-6Report Type:Expedited (15-DaCompany Report #02P-163-0201728-00 Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Chest Pain Dizziness Drug Interaction Extrapyramidal Disorder Health Professional Meridia 10 Mg (Meridia) (Sibutramine) (Sibutramine) PS 10 MG, 1 IN 1 Hyperglycaemia D, PER ORAL Hypotension Serotonin Syndrome Lithium (Lithium) Citalopram Hydrobromide Aspirin Buspirone Hydrochloride Trazodone SS C C C C ORAL Lisinopril Naproxen Glucophage Clozapine Risperidone Insulin Fluticasone C C C C C C C Date:10/11/02ISR Number: 3992715-4Report Type:Expedited (15-DaCompany Report #2002059783 Age:64 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 750 MG (BID) Initial or Prolonged 400 MG (BID), PT Report Source Product Role Confusional State Foreign Lithane (Lithium) PS Dehydration Literature Celebrex (Celecoxib) SS Gait Disturbance Health Nystagmus Thirst Tremor Professional Risperidone Venlafaxine C C ORAL 22-Aug-2005 Page: 470 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/02ISR Number: 3988688-0Report Type:Expedited (15-DaCompany Report #WAES 0205USA01719 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Coma Drug Interaction Dysarthria Oedema Peripheral Paraesthesia Product Role Manufacturer Route Vioxx Lithium Carbonate Paxil Glucophage Glucotrol Prilosec Lipitor Metamucil [Therapy Unspecified] PS SS SS C C C C C Merck & Co., Inc ORAL Manufacturer Route C Date:10/15/02ISR Number: 3992665-3Report Type:Expedited (15-DaCompany Report #2002059783 Age:64 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 750 MG (BID) Initial or Prolonged 400 MG (BID), PT Report Source Product Role Confusional State Foreign Lithane (Lithium) PS Dehydration Literature Celebrex (Celecoxib) SS Drug Interaction Consumer Drug Toxicity Gait Disturbance Nystagmus Thirst Tremor Health Professional Risperidone Venlafaxine C C ORAL ORAL Date:10/15/02ISR Number: 3993510-2Report Type:Expedited (15-DaCompany Report #2002057061 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 400 MG DAILY, Other ORAL PT Report Source Product Role Back Pain Confusional State Consumer Health Dilantin (Phenytoin Sodium) PS Convulsion Professional Manufacturer Route ORAL Depressed Level Of Lithium SS ORAL Consciousness Valproate Semisodium SS ORAL ORAL ORAL Difficulty In Walking Discomfort Drug Interaction Drug Level Decreased Drug Level Increased Drug Toxicity Dyskinesia Ecchymosis Fall Fear Inappropriate Affect Insomnia Mental Impairment Mental Status Changes Mood Altered Nervous System Disorder Rib Fracture Speech Disorder Tremor Weight Decreased 22-Aug-2005 Page: 471 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/02ISR Number: 3992987-6Report Type:Direct Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Company Report #CTU 178838 Report Source Polydipsia Product Role Lithium PS Manufacturer Route Manufacturer Route Date:10/16/02ISR Number: 3993210-9Report Type:Expedited (15-DaCompany Report #A0367112A Age:36 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Abdominal Distension Abdominal Pain Upper Asthenia Attention Health Professional Lithium Salt (Formulation Unknown) (Generic) (Lithium Salt) PS ORAL PER DAY/ ORAL Deficit/Hyperactivity Disorder Fatigue Gastrointestinal Ulcer Inflammation Myalgia Nausea Overdose Suicide Attempt Date:10/16/02ISR Number: 3999469-6Report Type:Expedited (15-DaCompany Report #B0282184A Age:47 YR Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Role Confusional State Coordination Abnormal Drug Level Increased Hypotension Mental Status Changes Renal Failure Literature Health Professional Lithium Salt (Formulation Unknown) (Lithium Salt) PS Duration Manufacturer Route Tachycardia Date:10/17/02ISR Number: 3996735-5Report Type:Expedited (15-DaCompany Report #B0281079A Age:59 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Haematemesis Haemoglobin Abnormal Foreign Lithium Salt (Lithium Salt) PS Co-Amilofruse Norethisterone Quinine Sulphate C C C Date:10/18/02ISR Number: 3992061-9Report Type:Expedited (15-DaCompany Report #B0281040A Age:24 YR Gender:Female I/FU:F Outcome Other 22-Aug-2005 Page: 472 PT Blister Depressed Mood Drug Withdrawal Syndrome 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeling Abnormal Headache Impulsive Behaviour Dose Report Source Nausea Restlessness Suicidal Ideation 15MG Per day Product Role Manufacturer Route Paxil Milnacipran Hydrochloride PS Glaxo Wellcome ORAL Lithium Carbonate SS Sodium Valproate SS Duration 10 SS ORAL DAY Glaxo Wellcome ORAL 600MG Twice per day ORAL 400MG Twice per day Date:10/18/02ISR Number: 3997450-4Report Type:Expedited (15-DaCompany Report #2002058798 Age:55 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Coordination Abnormal Health Lithane (Lithium) PS Dysarthria Pneumonia Somnolence Professional Risperidone Trifluoperazine Hydrochloride Carbamazepine Olanzapine SS Manufacturer Route ORAL C C C Date:10/18/02ISR Number: 3997463-2Report Type:Expedited (15-DaCompany Report #200220323US Age:54 YR Gender:Male I/FU:I Outcome Dose Disability Other 60 MG BID PT Report Source Product Role Agitation Difficulty In Walking Drug Interaction Consumer Fexofenadine Hydrochloride (Allegra) PS Fluid Retention Lithium Carbonate SS Oliguria Alprazolam (Xanax) Glyburide C C Duration 6 MON 600 MG BID Manufacturer Route Celecoxib (Celebrex) Nefazodone C C Date:10/21/02ISR Number: 3998254-9Report Type:Expedited (15-DaCompany Report #2002058798 Age:55 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Coordination Abnormal Health Lithane (Lithium) PS Drug Level Increased Dysarthria Nervous System Disorder Pneumonia Pyrexia Somnolence Professional Risperidone Trifluoperazine Hydrochloride Carbamazepine Olanzapine Hydrocortisone Neomycin SS Manufacturer Route ORAL C C C C C Date:10/23/02ISR Number: 3999416-7Report Type:Expedited (15-DaCompany Report #B0282448A Age:54 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Intentional Misuse Literature Health Professional Lithium Salt (Formulation Unknown) (Lithium Salt) PS ORAL Avandia (Formulation 22-Aug-2005 Page: 473 Manufacturer Route Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unknown) (Rosiglitazone Maleate) SS Fluvastatin Sodium (Formulation Unknown) (Fluvastatin Sodium) SS ORAL ORAL Date:10/23/02ISR Number: 3999468-4Report Type:Expedited (15-DaCompany Report #B0282449A Age:38 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Completed Suicide Intentional Misuse Literature Health Professional Lithium Salt (Formulation Unknown) (Lithium Salt) PS ORAL Venlafaxine Hydrochloride (Formulation Unknown) (Venlafaxine SS ORAL Benzodiazepines (Formulation Unknown) (Benzodiazepines) SS Duration ORAL ORAL Date:10/23/02ISR Number: 3999557-4Report Type:Expedited (15-DaCompany Report #B0282404A Age:53 YR Gender:Unknown I/FU:I Outcome Dose Death ORAL PT Report Source Product Role Completed Suicide Drug Level Above Therapeutic Intentional Misuse Literature Health Professional Lithium Salt (Formulation Unknown) (Lithium Salt) PS Manufacturer Route Duration ORAL Date:10/23/02ISR Number: 3999558-6Report Type:Expedited (15-DaCompany Report #B0282419A Age:51 YR Gender:Unknown I/FU:I Outcome Dose Death PT Report Source Product Completed Suicide Intentional Misuse Literature Health Professional Lithium Salt (Formulation Unknown) (Lithium Salt) Salicylate (Formulation Unknown) (Salicylate) Mirtazapine (Formulation Unknown) (Mirtazapine) Date:10/23/02ISR Number: 3999559-8Report Type:Expedited (15-DaCompany Report #B0282392A Age:27 YR Gender:Not SpecifiI/FU:I Outcome Death 22-Aug-2005 Page: 474 Role Duration PT Completed Suicide Drug Level Above 10:48 AM PS SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Intentional Misuse Dose Report Source Product Role Manufacturer Route Literature Health Professional Lithium Salt (Formulation Unknown)(Lithium Salt) PS ORAL Clonazepam (Formulation Unknown) (Clonazepam) SS ORAL Metformin Hydrochloride (Formulation Unknown) (Metformin Hydrochloride) SS ORAL Duration ORAL ORAL ORAL Date:10/23/02ISR Number: 3999581-1Report Type:Expedited (15-DaCompany Report #B0282426A Age:57 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Drug Level Above Therapeutic Medication Error Literature Health Professional Lithium Salt (Formulation Unknown) (Lithium Salt) PS Manufacturer Route Duration ORAL ORAL Date:10/23/02ISR Number: 3999583-5Report Type:Expedited (15-DaCompany Report #B0282428A Age:46 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Intentional Misuse Literature Health Professional Ltihium Salt (Formulation Unknown) (Lithium Salt) PS Manufacturer Route Duration ORAL Hydrocodone + ORAL Paracetamol (Formulation Unknown) (Hydrocodone + Sertraline (Formulation Unknown) (Sertraline) SS SS Date:10/24/02ISR Number: 3995631-7Report Type:Expedited (15-DaCompany Report #D0039574A Age:62 YR Gender:Female I/FU:I Outcome Dose Other 1 DAY PT Report Source Product Role Manufacturer Route Intentional Misuse Health Quilonum Retard PS Glaxo Wellcome ORAL Somnolence Professional Remergil SS Duration 7TAB Single Suicide Attempt dose 22-Aug-2005 Page: 475 1 DAY 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/02ISR Number: 4000424-0Report Type:Expedited (15-DaCompany Report #PHRM2002FR02543 Age:23 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Drug Level Above Therapeutic Foreign Health Leponex (Clozapine) Tablet PS ORAL Overdose Suicide Attempt Professional Other Teralhite (Lithium Carbonate) SS ORAL Amoxapine (Amoxapine) Diazepam C C Duration ORAL ORAL Toxicologic Test Abnormal Date:10/28/02ISR Number: 3997625-4Report Type:Expedited (15-DaCompany Report #A0383289A Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Eskalith PS Glaxo Wellcome Route Duration Drug Level Increased Overdose Date:10/28/02ISR Number: 3997633-3Report Type:Expedited (15-DaCompany Report #B0281040A Age:24 YR Gender:Female I/FU:F Outcome Dose Other 15MG Per day PT Report Source Product Role Manufacturer Route Blister Drug Withdrawal Syndrome Suicidal Ideation Health Professional Paxil Milnacipran Hydrochloride PS Glaxo Wellcome ORAL Lithium Carbonate SS Sodium Valproate SS Duration 10 SS ORAL DAY Glaxo Wellcome ORAL 600MG Twice per day 400MG Twice per day ORAL Date:10/28/02ISR Number: 4001575-7Report Type:Expedited (15-DaCompany Report #LBID00202002570 Age:9 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200 MG DAILY Initial or Prolonged PO PT Report Source Product Role Coordination Abnormal Literature Lithium (Lithium) PS Cough Health Dehydration Drug Level Above Therapeutic Influenza Mental Status Changes Nodal Arrhythmia Oral Intake Reduced Pyrexia Sinus Bradycardia Vomiting Professional Clozapine (Clozapine) C Manufacturer Route ORAL Date:10/28/02ISR Number: 4002629-1Report Type:Expedited (15-DaCompany Report #021022-PM0004-00 Age:61 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Confusional State Fall Foreign Health Professional Tranxene (Clorazepate Dipotassium) PS Zolpidem SS 10 MG, P.O. Other BID 10 MG, P.O. QD 22-Aug-2005 Page: 476 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium Carbonate SS ORAL Amitriptyline Hydrochloride SS ORAL Risperidone SS ORAL P.O. 25 MG, P.O. QD 1 MG, P.O. QD Date:10/29/02ISR Number: 4001223-6Report Type:Direct Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 900 MG PO QD 12 YR Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Product Role Blood Creatinine Lithium PS Increased Confusional State Parkinsonism Celexa Mirapex Sinemet Sinemet Cr Clonazepam Ambien Lipitor Lisinopril C C C C C C C C Date:10/31/02ISR Number: 4003059-9Report Type:Direct Age:68 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization PO, 150 -> Initial or Prolonged 450 MG Required Intervention to Prevent Permanent Impairment/Damage Company Report #CTU 179818 PT Coordination Abnormal Report Source Route ORAL Company Report #CTU 180100 Report Source Product Role Lithium - Various PS Ec Aspirin Levothyroxin Multivitamins Calc W/ Vit D Lithium Pericolace Pbn Oint Prevacid C C C C C C C C Difficulty In Walking Drooling Drug Toxicity Dysphagia Neurotoxicity Tremor Manufacturer Manufacturer Route ORAL Tylenol I Date:10/31/02ISR Number: 4003639-0Report Type:Expedited (15-DaCompany Report #DE9213421OCT2002 Age:57 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization VARIABLE Initial or Prolonged BETWEEN 2-4MG Other 41 DAY INTRAVENOUS PT Report Source Product Role Arteriosclerosis Study Tavor (Lorazepam) PS ORAL Route Delirium Antra (Omeprazole) SS ORAL Nervous System Disorder Aponal (Doxepin Hydrochloride) Augmentan I.V. (Amoxicillin Sodium/Clavulanate Potassium) SS ORAL Cerebellar Atrophy 12 SS DAY Augmentan Oral (Amoxicillin Trihydrate/Clavulana te Potassium) 7 Manufacturer SS ORAL SS ORAL DAY Jatrosom N (Tranylcypromine Sulfate) Quilonum - Slow Release (Lithium 22-Aug-2005 Page: 477 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Carbonate) SS ORAL Date:10/31/02ISR Number: 4004612-9Report Type:Expedited (15-DaCompany Report #DE9213421OCT2002 Age:57 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization VARIABLE Initial or Prolonged BETWEEN 2-4 Other MG ORAL ORAL 41 PT Report Source Product Role Manufacturer Route Cerebellar Atrophy Foreign Tavor (Lorazepam) PS ORAL Cerebral Atherosclerosis Health Confusional State Professional Delirium Other Antra (Omeprazole, , 0) SS ORAL Aponal (Doxepin Hydrochloride, , 0) SS ORAL Augmentan I.V. (Amoxicillin Sodium/Clavulanate Potassium, , ) SS Augmentan Oral (Amoxicillin Trihydrate/Clavulana te Potassium) SS ORAL Jatrosom N (Tranylcypromine Sulfate,) SS ORAL Quilonum - Slow Release (Lithium Carbonate, , 0) SS ORAL DAY ORAL FOR A LONG TIME INTRAVENOUS ORAL ORAL ORAL INTRAVENOUS 7 44 7 12 DAY DAY DAY DAY Date:11/01/02ISR Number: 4001433-8Report Type:Expedited (15-DaCompany Report #A0383937A Age:39 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Nephritis Interstitial Date:11/04/02ISR Number: 4028890-5Report Type:Periodic Age:70 YR Gender:Male I/FU:I Outcome Dose Product Role Manufacturer Route Eskalith Acyclovir PS C Glaxo Wellcome Glaxo Wellcome ORAL Manufacturer Route Manufacturer Route Company Report #CNL-127992-NL PT Report Source Product Role Pollakiuria Consumer Remeron Soltab PS Lithium SS Duration 67.5 DF DAILY DF DAILY Date:11/05/02ISR Number: 4005814-8Report Type:Expedited (15-DaCompany Report #2002-175 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600 MG, ORAL 20 YR Initial or Prolonged Disability ORAL (FEW Required DAYS) Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 478 10:48 AM PT Report Source Product Role Blood Creatinine Health Lithium 600 Mg PS Increased Dialysis Professional Pyridium Plus (Warner Chilcott) SS Hepatic Failure Nephropathy Toxic ORAL Warner Chilcott ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/02ISR Number: 4006946-0Report Type:Expedited (15-DaCompany Report #2002-DE-02568GD(0) Age:77 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 100 MG PT Report Source Product Role Atrial Fibrillation Bundle Branch Block Right Literature Lithium Carbonate (Lithium Carbonate) PS Conduction Disorder Drug Ineffective Desipramine (Desipramine) SS Electrocardiogram Abnormal Enalapri (Enalapril Maleate) Atenolol(Atenolol) Furosemide(Furosemid e) Warfarin (Warfarin) Levothydroxine(Levot hyroxine) Rosiglitazone (Drug Used In Diabetes) Metformin(Metformin) Manufacturer Route Manufacturer Route 450 MG C C C C C C C Date:11/06/02ISR Number: 4007369-0Report Type:Expedited (15-DaCompany Report #2002063980 Age:62 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 90 MG Other (DAILY), ORAL PT Report Source Product Role Asthenia Blood Creatine Increased Health Professional Nardil (Phenelzine Sulfate) PS ORAL Dehydration Lithium (Lithium) SS ORAL Haematocrit Abnormal Hyperpyrexia Pneumonia Aspiration Valproate Semisodium Butalbital W/Aspirin, Caffeine SS Confusional State ORAL ORAL Pollakiuria Pyrexia Tremor SS ORAL Date:11/06/02ISR Number: 4007786-9Report Type:Expedited (15-DaCompany Report #2002058798 Age:55 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Coordination Abnormal Health Lithane (Lithium) PS Csf Lymphocyte Count Abnormal Csf White Blood Cell Count Positive Dysarthria Medication Error Nervous System Disorder Overdose Pneumonia Pneumonia Aspiration Pyrexia Somnolence Professional Risperidone Trifluoperazine Hydrochloride Carbamazepine Olanzapine Neomycin SS Date:11/06/02ISR Number: 4008508-8Report Type:Expedited (15-DaCompany Report #2002063479 Age:78 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 479 10:48 AM PT Atrioventricular Block Blood Creatinine C C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Sinus Arrhythmia Dose Report Source Product Role Manufacturer Route Foreign Health Amlodipine (Amlodipine) PS ORAL Eupressyl (Urapidil) SS ORAL Aspirin Upsa (Acetylsalicylic Acid) SS ORAL Depamide (Valpromide) SS ORAL Teralithe (Lithium Carbonate) SS ORAL Duration 5 MG (DAILY), Professional ORAL 60 MG (DAILY), ORAL 325 MG (DAILY), ORAL 600 MG (DAILY), ORAL ORAL Date:11/07/02ISR Number: 4008902-5Report Type:Expedited (15-DaCompany Report #A214139 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization 100 MG Initial or Prolonged (DAILY), ORAL PT Report Source Product Role Bipolar Disorder Foreign Zoloft (Sertraline) PS Blood Creatine Increased Health Blood Creatine Phosphokinase Increased Blood Glucose Increased C-Reactive Protein Increased Encephalopathy Hallucinations, Mixed Nephropathy Professional Lithium Valproic Acid Lasix (Furosemide) Magnesium Allopurinol Tafil (Alprazolam) Stilnox (Zolpidem) SS C C C C C C Manufacturer Route ORAL Paranoia Date:11/07/02ISR Number: 4009343-7Report Type:Expedited (15-DaCompany Report #2002064377 Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 1200 MG Hospitalization (BID), ORAL Initial or Prolonged (DAILY), ORAL Other PT Report Source Product Role Blood Cholesterol Consumer Lithane (Lithium) PS ORAL 10:48 AM Route Cardiac Disorder Zoloft (Sertraline) SS ORAL Conduction Disorder Depression Lipitor (Atorvastatin) SS ORAL Drug Ineffective Eye Disorder Mental Disorder Ovarian Rupture Scar Surgical Procedure Repeated Thyroid Disorder Vision Blurred Weight Increased Potassium Diltiazem Hydrochloride Estrogens Conjugated Warfarin Lansoprazole Increased (DAILY), ORAL 22-Aug-2005 Page: 480 Manufacturer C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/02ISR Number: 4011841-7Report Type:Expedited (15-DaCompany Report #B0283458A Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Depression Drug Effect Decreased Hypomania Irritability Persecutory Delusion Serotonin Syndrome Urinary Incontinence White Blood Cell Count Increased Foreign Literature Health Professional Lithium Salt (Lithium Salt) Citalopram Olanzapine PS C C Manufacturer Route Manufacturer Route Date:11/08/02ISR Number: 4009145-1Report Type:Expedited (15-DaCompany Report #LBID00202002798 Age:46 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Drug Level Increased Intentional Misuse Literature Health Professional Lithium Carbonate [Manufacturer Unknown] (Lithium Carbonate Manufacturer PS ORAL Acetaminophen W/Hydrocodone Bitartrate (Acetaminophen W/Hydrocodone SS ORAL Sertraline (Sertraline) SS ORAL Duration DAILY PO DAILY PO DAILY PO Date:11/08/02ISR Number: 4009149-9Report Type:Expedited (15-DaCompany Report #LBID00202002796 Age:57 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Drug Level Increased Medication Error Literature Health Lithium Carbonate [Manufacturer Duration Role Manufacturer Route Overdose Professional Unknown] (Lithium Carboate [Manufacturer PS ORAL DAILY PO Date:11/08/02ISR Number: 4009153-0Report Type:Expedited (15-DaCompany Report #LBID00202002786 Age:54 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Completed Suicide Drug Level Increased Intentional Misuse Literature Health Professional Lithium Carbonate (Manufacture Unknown) (Lithium Carbonate (Manufacture PS Fluvastatin (Fluvastatin) SS ORAL Rosiglitazone (Rosiglitazone) SS ORAL Duration DAILY PO DAILY PO PO 22-Aug-2005 Page: 481 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/02ISR Number: 4009155-4Report Type:Expedited (15-DaCompany Report #LBID00202002787 Age:53 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Drug Level Increased Overdose Literature Health Professional Lithium Carbonate (Manufacturer Unknown) (Lithium Carbonate (Manufacturer PS Manufacturer Route Duration ORAL DAILY PO Date:11/08/02ISR Number: 4009161-XReport Type:Expedited (15-DaCompany Report #LBID00202002788 Age:38 YR Gender: I/FU:I Outcome Dose Death DAILY PO PT Report Source Product Role Manufacturer Route Cardio-Respiratory Arrest Literature Lithium Carbonate PS ORAL Completed Suicide Health Professional Venlafaxine (Venlafaxine) SS ORAL Benzodiazepine (Benzodiazepine) SS ORAL Duration DAILY PO DAILY PO Date:11/08/02ISR Number: 4009166-9Report Type:Expedited (15-DaCompany Report #LBID00202002785 Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Death DAILY PO Hospitalization Initial or Prolonged PT Report Source Product Role Confusional State Literature Lithium Carbonate PS Coordination Abnormal Drug Level Increased Hypotension Mental Status Changes Overdose Renal Failure Tachycardia Health Professional Manufacturer Route ORAL Date:11/08/02ISR Number: 4009746-0Report Type:Expedited (15-DaCompany Report #2002UW14815 Age: Gender:Female I/FU:I Outcome Dose Duration Required 300 MG PO Intervention to 225 MG Prevent Permanent 450 MG Impairment/Damage PT Report Source Product Role Diabetes Insipidus Health Seroquel PS Professional Effexor-Xr SS Eskalith SS Date:11/12/02ISR Number: 4008381-8Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Death 22-Aug-2005 Page: 482 PT 10:48 AM Route ORAL Company Report #CTU 180779 Report Source Product Role Lithium PS Duration Cardiac Disorder Cardio-Respiratory Arrest Dysarthria Mental Status Changes Syncope Manufacturer Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/02ISR Number: 4011507-3Report Type:Expedited (15-DaCompany Report #LBID00202001237 Age:43 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG DAILY PT Report Source Product Role Dental Caries Dialysis Consumer Lithobid (Lithium Carbonate) PS Manufacturer Route ORAL Drug Level Above PO Therapeutic Drug Toxicity Foot Fracture Nail Disorder Tooth Disorder Tooth Loss Toothache Premarin (Estrogens Conjugated) Allegra (Fexofenadine Hydrochloride) Prilosec (Omeprazole) Lorazepam (Lorazepam) Ambien (Zolpidem Tartrate) C C C C C Date:11/13/02ISR Number: 4011968-XReport Type:Expedited (15-DaCompany Report #PHNU2002DE03696 Age:21 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Convulsion Drug Interaction Drug Level Increased Foreign Health Professional Leponex Clozaril (Clozapine) (Clozapine) Tablet PS ORAL Hypnorex - Slow Release (Lithium Carbonate) Slow Release Tablet SS ORAL Duration 300 MG/DAY, Other ORAL ORAL Date:11/14/02ISR Number: 4009185-2Report Type:Expedited (15-DaCompany Report #D0039742A Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Other 2TAB Per day PT Report Source Road Traffic Accident Product Role Manufacturer Route Quilonum Retard PS Glaxo Wellcome ORAL Product Role Manufacturer Route Lithium PS Somnolence Date:11/14/02ISR Number: 4010018-9Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Death PT Company Report #CTU 180895 Report Source Duration Cardio-Respiratory Arrest Drug Level Above Therapeutic Dysarthria Mental Status Changes Syncope Date:11/15/02ISR Number: 4010466-7Report Type:Expedited (15-DaCompany Report #WAES 0204SWE00002 Age:81 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 483 10:48 AM PT Depressed Level Of Consciousness Drug Level Increased Extrapyramidal Disorder FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Medication Error Renal Failure Dose 25 Report Source Product Role Manufacturer Route Vioxx PS Merck & Co., Inc ORAL Lithium Sulfate Levothyroxine Sodium Dipyridamole Lofepramine Hydrochloride Zolpidem Tartrate Calcium Carbonate And Cholecalciferol Tramadol Hydrochloride SS C C Duration DAY Date:11/18/02ISR Number: 4011531-0Report Type:Direct Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 450MG PO BID Hospitalization [LONG Initial or Prolonged STANDING] PT Drug Toxicity C C C C Company Report #CTU 181147 Report Source Product Role Eskalith PS Cipro SS Hypercalcaemia Nephrogenic Diabetes Insipidus ORAL DOSE NOT Renal Failure Acute DOCUMENTED [FOR 1 MONTH PRIOR TO EVENT] Date:11/20/02ISR Number: 4012204-0Report Type:Expedited (15-DaCompany Report #B0284518A Age:51 YR Gender:Female I/FU:I Manufacturer Route ORAL Outcome Dose Duration Life-Threatening Hospitalization 10MG Per day Initial or Prolonged 500MG Three Disability times per day PT Report Source Product Role Manufacturer Route Condition Aggravated Nephrogenic Diabetes Lithium Atorvastatin PS C Glaxo Wellcome ORAL ORAL Insipidus Metformin C ORAL Sodium Valproate C ORAL Fenofibrate C ORAL Pneumonia Pulmonary Embolism 300MG Twice Renal Tubular Necrosis per day Shock Urinary Incontinence Date:11/22/02ISR Number: 4016133-8Report Type:Expedited (15-DaCompany Report #12109385 Age:27 YR Gender: I/FU:I Outcome Dose Death ORAL Other ORAL PT Report Source Product Role Manufacturer Route Completed Suicide Literature Metformin Hcl PS ORAL Overdose Health Clonazepam SS ORAL Professional Lithium (Lithium Salts) SS ORAL Duration ORAL Date:11/25/02ISR Number: 4016215-0Report Type:Expedited (15-DaCompany Report #MK200211-0206-1 Age:46 YR Gender: I/FU:I Outcome Dose Death 22-Aug-2005 Page: 484 PT Report Source Product Role Completed Suicide Overdose Literature Health Professional Hydrocodone/Apap Lithium Carbonate Sertraline PS SS SS Duration 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/02ISR Number: 4015899-0Report Type:Direct Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization TID PO Initial or Prolonged PO QD Required Intervention to Prevent Permanent Impairment/Damage PT Product Role Confusional State Lithium 450 Cr PS ORAL Drug Level Increased Maxzide 75/50 SS ORAL Report Source Manufacturer Route Tremor Visual Disturbance Date:11/26/02ISR Number: 4015959-4Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 600 MG BID PO Initial or Prolonged Company Report #CTU 181692 PT Company Report #CTU 181776 Report Source Product Role Asthenia Lithium PS Constipation Drug Level Increased Somnolence Tremor Benztropine Olanzapine Risperidone Ranitidine Loperamide Macrodantin C C C C C C Manufacturer Route ORAL Date:11/26/02ISR Number: 4018015-4Report Type:Expedited (15-DaCompany Report #2002066670 Age: Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Role Overdose Health Professional Lithane (Lithium) Ziprasidone PS C Manufacturer Route Manufacturer Route Duration Date:11/26/02ISR Number: 4018019-1Report Type:Expedited (15-DaCompany Report #2002058798 Age:55 YR Gender:Male I/FU:F Outcome Dose PT Duration Report Source Product Role Hospitalization ORAL Initial or Prolonged Coordination Abnormal Health Lithane (Lithium) PS Csf Test Abnormal Dysarthria Mental Status Changes Motor Dysfunction Nervous System Disorder Overdose Pneumonia Aspiration Pyrexia Somnolence Professional Risperidone Trifluoperazine Hydrochloride Carbamazepine Olanzapine Hydrocortisone Neomycin SS ORAL C C C C C Date:11/27/02ISR Number: 4019037-XReport Type:Expedited (15-DaCompany Report #2002067242 Age: Gender:Female I/FU:I Outcome Dose Duration Death Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 485 10:48 AM PT Report Source Product Role Hepatic Failure Sepsis Health Professional Geodon (Ziprasidone) Metformin Ramipril Quetiapine Fumarate Lithium Carbonate PS SS SS SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/02ISR Number: 4019313-0Report Type:Expedited (15-DaCompany Report #2002-BP-05509RO (0) Age:28 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Disability PO PT Report Source Product Role Manufacturer Route Dialysis Hypertension Renal Failure Chronic Consumer Health Professional Lithium Carbonate Capsules Usp, 300 Mg (Lithium Carbonate) PS Usp ORAL Renal Transplant Thyroid Disorder Weight Increased Date:12/02/02ISR Number: 4017521-6Report Type:Expedited (15-DaCompany Report #D0039829A Age:44 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Delirium 450MG Unknown 3 DAY Initial or Prolonged Drug Interaction 2 DAY Drug Level Increased 30 DAY Report Source Product Role Manufacturer Route Health Quilonum Retard PS Glaxo Wellcome ORAL Professional Zyprexa SS ORAL Laubeel C ORAL Date:12/02/02ISR Number: 4017522-8Report Type:Expedited (15-DaCompany Report #D0039832A Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 450MG per day Initial or Prolonged 75MG per day PT Report Source Product Role Manufacturer Route Mental Impairment Health Quilonum Retard PS Glaxo Wellcome ORAL Serotonin Syndrome Professional Stangyl SS ORAL Trevilor Ass SS C ORAL ORAL Beloc Zok C ORAL Kalium Duriles C ORAL Vitamins C ORAL 100MG per day 100MG per day 1TAB per day 60DROP per day Diazepam 15 C ORAL DAY Date:12/03/02ISR Number: 4018206-2Report Type:Expedited (15-DaCompany Report #B0286643A Age:9 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Agitation Anger Anxiety Depression Drug Ineffective Insomnia Suicidal Ideation Consumer Paxil Lithium Risperidone Gabapentin PS SS SS SS Glaxo Wellcome Glaxo Wellcome Route Duration Date:12/03/02ISR Number: 4018207-4Report Type:Expedited (15-DaCompany Report #D0039828A Age:64 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 2.5TAB per Hospitalization day Initial or Prolonged 120MG per day PT Report Source Product Role Manufacturer Route Myocardial Infarction Health Quilonorm Retard PS Glaxo Wellcome ORAL Suicide Attempt Professional Remeron SS ORAL Imovane SS ORAL Extract Of Valerian C ORAL Aspirin C ORAL 15MG per day 1TAB per day 300MG per day 22-Aug-2005 Page: 486 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/02ISR Number: 4018222-0Report Type:Expedited (15-DaCompany Report #A0386369A Age:19 YR Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Drug Interaction RESPIRATORY Initial or Prolonged Gait Disturbance (INHALATION) 2PUFF Four Grand Mal Convulsion times per day Road Traffic Accident RESPIRATORY Serotonin Syndrome (INHALATION) 2PUFF Twice Speech Disorder per day UNKNOWN Report Source Product Role Manufacturer Consumer Albuterol PS Glaxo Wellcome Salmeterol SS Glaxo Wellcome Montelukast SS Budesonide SS Phenobarbital SS Diazepam SS Lithium Carbonate Paroxetine Cromoglycate Omeprazole SS SS C C Lansoprazole C Venlafaxine C Route 20MG per day RESPIRATORY (INHALATION) 2PUFF Twice per day INTRAVENOUS INTRAVENOUS 20MG At night 20MG At night 75MG In the morning Date:12/03/02ISR Number: 4018266-9Report Type:Expedited (15-DaCompany Report #B0286643A Age:9 YR Gender:Male I/FU:I Glaxo Wellcome Glaxo Wellcome ORAL ORAL Outcome Dose Other PT Report Source Product Role Manufacturer Route Paxil Lithium Risperidone Gabapentin PS SS SS SS Glaxo Wellcome Glaxo Wellcome Product Role Manufacturer Route Neurontin (Gabapentin) Geodon (Ziprasidone) PS SS Clozappine Lithium SS SS Manufacturer Route Duration Agitation Anger Anxiety Bipolar Disorder Drug Ineffective Insomnia Malaise Suicidal Ideation Date:12/03/02ISR Number: 4021016-3Report Type:Expedited (15-DaCompany Report #2002068179 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other 120 MG BID PT Report Source Cardio-Respiratory Arrest Delirium Date:12/05/02ISR Number: 4024431-7Report Type:Periodic Age:32 YR Gender:Male I/FU:I Outcome Dose Disability Other Company Report #HQ9377811DEC2001 PT Report Source Product Role Priapism Health Professional Effexor Xr (Venlafaxine Hydrochloride, Capsule, Extended Release) PS Duration 300 MG 1 X PER 1 DAY, ORAL Clozaril (Clozapine, 22-Aug-2005 Page: 487 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ) SS ORAL SS ORAL SS ORAL 50 MG 1X PER 1 DAY, ORAL Klonopin (Clonazepam, ) 2 MG 1X PER 1 DAY, ORAL Lithium (Lithium, ) 300 MG TO 1500 MG DAILY AT BEDTIME, ORAL Date:12/09/02ISR Number: 4023123-8Report Type:Expedited (15-DaCompany Report #2002069558 Age:46 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Intentional Misuse Literature Health Sertraline (Sertraline) PS Professional Lithane (Lithium) SS Vicodin SS Manufacturer Route Manufacturer Route Duration (DAILY) (DAILY) (DAILY) Date:12/09/02ISR Number: 4031076-1Report Type:Periodic Age:69 YR Gender:Male I/FU:F Outcome Dose Company Report #2002114176US PT Report Source Product Role Delirium Drug Interaction Consumer Health Bextra(Valdecoxib) (Continued) PS Lithium(Lithium) SS Duration 20 MG, QD, Professional ORAL UNK, UNK, UNK Itraconazole(Itracon ORAL azole) SS Wellbutrin (Amfebutamone Hydrochloride) Prilosec Atenolol Vitamin E Aspirin "Bayer" C C C C C UNK, UNK, UNK Date:12/10/02ISR Number: 4025124-2Report Type:Expedited (15-DaCompany Report #HQ5609604DEC2002 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Complications Of Maternal Exposure To Therapeutic Drugs Drug Level Increased Goitre Congenital Maternal Drugs Affecting Foetus Literature Effexor (Venlafaxine Hydrochloride, Unspec) Lithium (Lithium, ) Cyamemazine (Cyamemazine) Olanzapine (Olanzapine) Date:12/10/02ISR Number: 4025132-1Report Type:Expedited (15-DaCompany Report #B0285794A Age:84 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 488 Role Manufacturer Route Duration 10:48 AM PT Accidental Exposure Clonic Convulsion Confusional State Hypertension PS SS C C ORAL ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lack Of Spontaneous Speech Mental Status Changes Dose Report Source Product Role Foreign Literature Health Professional Eskalith (Formulation Unknown) (Lithium Carbonate) Lisinopril PS C Manufacturer Route Manufacturer Route Manufacturer Route Duration Status Epilepticus Tremor Date:12/10/02ISR Number: 4025553-7Report Type:Expedited (15-DaCompany Report #PHBS2002JP14775 Age:69 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 75 MG/DAY PT Report Source Product Role Arthralgia Clonic Convulsion Foreign Literature Diclofenac(Diclofena c) PS Depressed Level Of Consciousness Health Professional Lithium Carbonate (Lithium Carbonate) SS Diabetes Mellitus Non-Insulin-Dependent Drug Interaction Drug Toxicity Dyskinesia Electrocardiogram Delta Waves Abnormal Mania Tremor Other Haloperidol C 600 MG/DAY Date:12/11/02ISR Number: 4022261-3Report Type:Direct Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300MG PO TID Initial or Prolonged CHRONIC PT Anaemia Report Source Product Role Lithium PS Chlorpromazine SS Drug Toxicity Hyponatraemia 100 MG Q AM Company Report #CTU 182514 ORAL Nephrogenic Diabetes 200 MG Q PM Insipidus CHRONIC Renal Impairment Urinary Tract Infection Amitriptyline Vit E Synthroid Lorazepam Avandia Premphase Docusate Bethanecol Aspirin Iron C C C C C C C C C C Date:12/11/02ISR Number: 4024892-3Report Type:Expedited (15-DaCompany Report #2002-11-2655 Age:13 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Drug Interaction Heart Rate Decreased Consumer Company Representative Clarinex (Desloratadine) Tablets PS Risperdal Tablets SS Eskalith Capsules SS 5MG PRN ORAL 0.75 QD 450MG BID 22-Aug-2005 Page: 489 Manufacturer Route Duration 2 YR 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/02ISR Number: 4025277-6Report Type:Expedited (15-DaCompany Report #02P-163-0205275-00 Age:46 YR Gender:Unknown I/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Literature Health Professional Hydrocodone/Acetamin ophen (Vicodin) (Hydrocodone/Acetami nophen)(Hydrocodone Acetaminophen) Lithium Sertraline PS SS SS Manufacturer Route Duration Date:12/16/02ISR Number: 4023975-1Report Type:Expedited (15-DaCompany Report #D0039742A Age:53 YR Gender:Female I/FU:F Outcome Dose Other 1TAB Twice PT Report Source Product Role Manufacturer Route Depression Health Quilonum Retard PS Glaxo Wellcome ORAL Road Traffic Accident Professional Manufacturer Route Duration per day Date:12/16/02ISR Number: 4027608-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB02068 Age:29 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 500 MG/DAY, PT Report Source Product Role Nephropathy Toxic Renal Failure Foreign Health Clozaril (Clozapine) Tablet PS Lithium(Lithium) SS ORAL Professional ORAL Other Date:12/18/02ISR Number: 4025779-2Report Type:Direct Age:58 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening PT Dehydration Company Report #CTU 182905 Report Source Product Lithium Carbonate Role Manufacturer Route Hospitalization 2 CAPSULES, Initial or Prolonged BID PO Diabetes Insipidus 300mg Capsules Diabetes Mellitus Drug Toxicity Hypernatraemia Mental Status Changes Oxygen Saturation Decreased Renal Failure Acute Date:12/19/02ISR Number: 4030184-9Report Type:Expedited (15-DaCompany Report #2002-BP-05509RO Age:28 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged Disability 22-Aug-2005 Page: 490 10:48 AM PT Anaemia Arthralgia Basal Cell Carcinoma Blood Calcium Increased Dialysis Drug Level Increased Fibrocystic Breast Disease Haematocrit Decreased Hyperreflexia Hypertension Nocturia PS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Pollakiuria Renal Failure Chronic Renal Transplant Report Source Product Role Speech Disorder Thyroid Disorder Tremor Consumer Health Professional Lithium Carbonate Capsules Usp, 300 Mg (Lithium Carbonate) PS Manufacturer Route Manufacturer Route Manufacturer Route Duration FROM HIGH OF Urinary Tract Infection 900 MG/DAY TO Weight Increased LOW OF White Blood Cell Count Decreased Ismelin (Guanethidine Sulfate) Minipress (Prazosin Hydrochloride) Prinivil (Lisinopril) Prolixin (Fluphenazine Hydrochloride) Theragran (Theragran) Vitamin E (Tocopherol) Metamucil (Psyllium Hydrophilic Mucilloid) Date:12/23/02ISR Number: 4029184-4Report Type:Direct Age:82 YR Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Dehydration Delirium PT Duration C C C C C C Company Report #CTU 183289 Date:12/26/02ISR Number: 4038223-6Report Type:Periodic Age:29 YR Gender:Male I/FU:I Outcome Dose C Product Role Lithium 300mg Qam, 450mg Q Pm PS Company Report #02-05-0521 Report Source Product Role Hospitalization Initial or Prolonged Other Convulsion Other Clozapine - Ivax Pharmaceuticals, Inc. Tablets PS Ivax Pharmaceuticals, Inc. ORAL Manufacturer Route 25-150 MG QD ORAL Lithium Unknown SS Date:12/30/02ISR Number: 4036153-7Report Type:Expedited (15-DaCompany Report #B0288424A Age:63 YR Gender:Female I/FU:I Outcome Dose Other ORAL 22-Aug-2005 Page: 491 PT Report Source Product Role Ascites Foreign Eskalith Tablet PS Essential Tremor Pleural Effusion Health Professional Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/03ISR Number: 4035108-6Report Type:Direct Age:30 YR Gender:Female I/FU:I Outcome Dose Other PT Company Report #CTU 183745 Report Source Product Role Manufacturer Route Priadel -Lithium400mg/200mg PS ORAL Thirodizine-Mellirel - 100mg/50mg SS ORAL Duration Cognitive Disorder Memory Impairment 1000MG ONCE Thought Blocking AT ORAL 1000MG/X 4 PER ORAL Date:01/03/03ISR Number: 4035385-1Report Type:Direct Age:70 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Lithium Simvastatin Ibuprofen Bupropion Hcl Hydrocortisone Acetate Paroxetine Hcl Clonazepam Olanzapine Sertraline Hcl Trazodone Hcl Ipratropium Bromide PS C C C Manufacturer Route Manufacturer Route Duration Blood Creatinine Increased Date:01/03/03ISR Number: 4035408-XReport Type:Direct Age:29 YR Gender:Male I/FU:I Outcome Dose Other Company Report #CTU 183811 PT C C C C C C C Company Report #CTU 183809 Report Source Product Role Lithium Felodipine Fluticas 500/Salmeterol 50 PS C Duration Blood Creatinine Increased Inhl Disk 60 Buspirone Hcl Lithium Carbonate Olanzapine Paroxetine Hcl Sertraline Hcl Trazodone Hcl Ipratropium Bromide C C C C C C C C Date:01/06/03ISR Number: 4036011-8Report Type:Expedited (15-DaCompany Report #B0288724A Age:29 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization UNKNOWN Initial or Prolonged 500MG per day Other 22-Aug-2005 Page: 492 10:48 AM PT Report Source Product Role Manufacturer Nephropathy Toxic Consumer Lithium PS Glaxo Wellcome Clozaril SS Renal Failure Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/06/03ISR Number: 4036012-XReport Type:Expedited (15-DaCompany Report #D0040113A Age:38 YR Gender:Female I/FU:F Outcome PT Dose Duration Hospitalization Dry Mouth 450MG See Initial or Prolonged Gastrointestinal Disorder dosage text 1 DAY Hypotonia 7.5MG See Intentional Misuse dosage text 1 DAY Suicide Attempt 100MG See dosage text 1 Report Source Product Role Manufacturer Route Health Quilonum Retard PS Glaxo Wellcome ORAL Zopiclone SS ORAL Trimipramine SS ORAL Ergenyl Chrono SS ORAL Professional DAY 300MG See dosage text 1 DAY Date:01/06/03ISR Number: 4036984-3Report Type:Direct Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Dizziness Initial or Prolonged Medication Error 2700MG PO QD 2 DAY Overdose Date:01/06/03ISR Number: 4036985-5Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization PO ALT BID Initial or Prolonged /TID QOD CHRONIC PT Drug Toxicity Company Report #CTU 183931 Report Source Product Role Lithium (Liquid-Unit Dose Padeaging) PS Manufacturer Route ORAL Company Report #CTU 183932 Report Source Product Role Lithium 450mg PS Manufacturer Route ORAL Date:01/10/03ISR Number: 4040145-1Report Type:Direct Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Other 900 MG 300 MG PT Company Report #CTU 184198 Report Source Tremor Product Role Lithium PS Manufacturer Route ORAL PO ORAL Date:01/10/03ISR Number: 4041165-3Report Type:Expedited (15-DaCompany Report #03P-056-0207494-00 Age:69 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Loss Of Consciousness Prostatic Pain Urinary Retention Foreign Health Professional Depakote (Divalproex Sodium) (Divalproex Sodium) PS ORAL Mirtazapine SS ORAL Zopiclone SS ORAL Propranolol SS Lithium Carbonate SS ORAL Cisapride SS ORAL Alfuzosin C Duration 500 MG, ORAL 5 MG, 3 IN 1 D, ORAL 15 MG, 1 IN 1 D, ORAL RECTAL 60 MG, 1 IN 1 D, RECTAL 200 MG, 2 IN 1 D, ORAL ORAL 22-Aug-2005 Page: 493 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/10/03ISR Number: 4041506-7Report Type:Expedited (15-DaCompany Report #2002066670 Age: Gender:Female I/FU:F Outcome Dose Death PT Report Source Product Role Overdose Treatment Noncompliance Health Professional Lithane (Lithium) PS Manufacturer Route Manufacturer Route Duration Date:01/13/03ISR Number: 4041984-3Report Type:Expedited (15-DaCompany Report #030109-PM0019-00 Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Bradycardia Foreign Health Professional Tranxene (Clorazepate Dipotassium) PS ORAL Other Lithium Carbonate SS ORAL Olanzapine SS ORAL Zopiclone SS ORAL 5 MG, P.O. QD 250 MG, P.O. BID 10 MG, P.O. QD 7.5 MG, P.O. QD YR Date:01/14/03ISR Number: 4041954-5Report Type:Direct Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Confusional State Dizziness Date:01/14/03ISR Number: 4041977-6Report Type:Direct Age:68 YR Gender:Male I/FU:I Company Report #CTU 184468 Report Source Product Role Lithium PS Company Report #CTU 184478 Manufacturer Route Outcome Dose Duration Hospitalization Initial or Prolonged PT Confusional State Diarrhoea Difficulty In Walking Nausea Vomiting Date:01/15/03ISR Number: 4042601-9Report Type:Direct Age:39 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization PO Initial or Prolonged Report Source PT Product Role Lithium PS Product Role Depressed Level Of Lithium PS Consciousness Difficulty In Walking Drug Level Increased Drug Screen Positive Lethargy Respiratory Depression Somnolence Buspar Valproic Acid C C 22-Aug-2005 Page: 494 PT Cholelithiasis Nephrolithiasis 10:48 AM Route Manufacturer Route Company Report #CTU 184591 Report Source Date:01/15/03ISR Number: 4043779-3Report Type:Expedited (15-DaCompany Report #2003-DE-00019YA (0) Age:65 YR Gender:Male I/FU:I Outcome Disability Manufacturer ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Cyst Renal Failure Dose 0.4 MG PO Report Source Product Role Manufacturer Route Foreign Flomax PS ORAL Other Depamide (Valpromide) (Nr) SS ORAL Teralithe (Lithium Carbonate) (Nr) SS ORAL Tadenan (Pygeum Africanum) (Nr) SS ORAL Duration 365 DAY 300 MG PO 1500 MG PO 100 MG PO Date:01/16/03ISR Number: 4044082-8Report Type:Expedited (15-DaCompany Report #PHBS2002JP14758 Age:69 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Akathisia Blood Creatine Phosphokinase Increased Foreign Health Professional Parlodel (Bromcriptine Mesilate) Unknown PS ORAL Blood Creatinine Other Barnetil (Sultopride) SS ORAL Limas (Lithium Carbonate) SS ORAL Lodopin (Zotepine) SS ORAL Coniel (Benidipine Hydrochloride) SS 7.5 MG/DAY, ORAL2.5 Increased MG/DAY, ORAL Hyperhidrosis Hypertension 800 MG/DAY, Parkinsonism ORAL 400 MG/DAY, ORAL 400 MG/DAY, ORAL Inhibace Roche (Cilazapril) Amoban Benzalin Hirnamin Pyrethia SS C C C C Roche Product Role Manufacturer Route Quilonum Cipramil PS C Glaxo Wellcome ORAL ORAL Trimipramine C ORAL Zopiclone Fosinorm C C ORAL ORAL Dociton C Unat C Date:01/20/03ISR Number: 4043547-2Report Type:Expedited (15-DaCompany Report #D0040150A Age:72 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Duration Renal Impairment 20MG In the morning 100MG Per day 10MG In the morning Glaxo Wellcome ORAL 20MG Twice per day ORAL 5MG Per day Date:01/21/03ISR Number: 4043970-6Report Type:Direct Age:9 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 60MG DAILY Initial or Prolonged ORAL 22-Aug-2005 Page: 495 10:48 AM PT Mania Company Report #CTU 184834 Report Source Product Role Geodon PS Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithobid DAILY SS ORAL ORAL Date:01/21/03ISR Number: 4044696-5Report Type:Expedited (15-DaCompany Report #2003-DE-00014GD Age:20 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Akathisia Initial or Prolonged Bipolar Disorder SEE IMAGE 3 MON Body Temperature Increased 3 MG NR Cognitive Disorder Constipation 20 MG NR Drug Interaction Drug Level Below SEE IMAGE Therapeutic Dry Mouth Parkinsonian Crisis 2 MG Vision Blurred Report Source Product Role Literature Lithium Carbonate (Lithium Carbonate) PS Risperidone (Risperidone) SS Paroxetine (Paroxetine) SS Olanzapine (Antipsychotics) SS Benztropine (Benzatropine Mesilate) SS Nortriptyline (Nortriptyline) SS Manufacturer Route Manufacturer Route 50 MG Date:01/21/03ISR Number: 4044717-XReport Type:Expedited (15-DaCompany Report #2003UW00549 Age: Gender: I/FU:I Outcome Dose Duration Hospitalization 600 MG PO Initial or Prolonged PT Report Source Product Role Ammonia Increased Health Seroquel PS Professional Lithium SS Date:01/21/03ISR Number: 4045925-4Report Type:Expedited (15-DaCompany Report #2003-DE-00095GD Age:1 DY Gender:Male I/FU:I ORAL Outcome Dose Duration Other Required INTRA-UTERINE IU Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Apgar Score Low Goitre Foreign Literature Lithium Carbonate (Lithium Carbonate) PS Hypothyroidism Maternal Drugs Affecting Foetus Neonatal Disorder Pregnancy Small For Dates Baby Cyamemazine Venlafaxine (Antidepressants) Olanzapine (Antipsychotics) Manufacturer Route Manufacturer Route C C C Date:01/23/03ISR Number: 4047068-2Report Type:Expedited (15-DaCompany Report #2002067242 Age:58 YR Gender:Female I/FU:F Outcome Dose Duration Death ORAL Hospitalization 500 MG Initial or Prolonged (DAILY), ORAL Other PT Report Source Product Role Autoimmune Hepatitis Health Geodon (Ziprasidone) PS ORAL Cholelithiasis Professional Metformin SS ORAL Ramipril Quetiapine Fumarate SS SS Lithium Carbonate Vitamins Docusate Sodium Psyllium SS C C C General Physical Health Deterioration Hepatic Failure 100 MG Ischaemia (DAILY) Pancreatitis Sepsis 22-Aug-2005 Page: 496 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/28/03ISR Number: 4049015-6Report Type:Expedited (15-DaCompany Report #B0289517A Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Hyperthyroidism Thyroiditis Foreign Literature Health Professional Lithium Carbonate (Formulation Unknown) (Generic) (Lithium Carbonate) PS Manufacturer Route Manufacturer Route Date:01/29/03ISR Number: 4050057-5Report Type:Expedited (15-DaCompany Report #LBID00203000023 Age:48 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG BID PO PT Report Source Product Role Diabetes Insipidus Lethargy Health Professional Lithobid (Lithium Carbonate) PS Mood Altered Oedema Peripheral Pneumonia Depakote (Valproate Semisodium) Risperdal (Risperidone) Vitamin D (Vitamin D) Multivitamins (Multivitamins) Actonel (Actonel) Warfarin (Warfarin) ORAL C C C C C C Date:01/30/03ISR Number: 4049392-6Report Type:Expedited (15-DaCompany Report #B0290594A Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 284 DAY Other PT Report Source Product Role Manufacturer Abdominal Pain Coordination Abnormal Consumer Lithium Clozaril PS SS Glaxo Wellcome Dehydration Diabetes Insipidus Grand Mal Convulsion Route ORAL Date:01/30/03ISR Number: 4050493-7Report Type:Expedited (15-DaCompany Report #PHBS2003JP00627 Age:40 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 25 MG/DAY, PT Report Source Product Role Depressed Level Of Consciousness Foreign Literature Voltaren(Diclofenac Sodium) Tablet PS Drug Interaction Health Drug Toxicity Mouth Breathing Professional Other Lithium Carbonate(Lithium Carbonate) SS ORAL 400 MG/DAY Date:01/30/03ISR Number: 4050883-2Report Type:Expedited (15-DaCompany Report #HQ6252120JAN2003 Age:69 YR Gender:Male I/FU:I Outcome Death 22-Aug-2005 Page: 497 PT Bladder Dilatation Drug Level Below Therapeutic Drug Toxicity Hydronephrosis Inflammation Loss Of Consciousness 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Cyst Sudden Death Urinary Retention Dose Report Source Product Role Manufacturer Route Health Professional Other Avlocardyl (Propranolol Hydrochloride, Tablet) PS ORAL Depakote (Valproate Semisodium) SS ORAL Imovane (Zopiclone) SS ORAL Monuril (Fosfomycin Trometamol) SS ORAL Teralithe (Lithium Carbonate) SS ORAL Xatral (Alfuzosin) SS ORAL Spasfon (Phloroglucinol/Trim ethylphloroglucinol) SS ORAL Mirtazapine SS ORAL Prepulsid (Cisapride) C Duration 60 MG 1 X PER 1 DAY, ORAL 1500 MG 1X PER 1 DAY, ORAL 15 MG 1X PER 1 DAY, ORAL ORAL 800 MG 1X PER 1 DAY, ORAL 5 MG 1X PER 1 DAY, ORAL ORAL 3 "DF" DAILY, ORAL Date:01/31/03ISR Number: 4051233-8Report Type:Expedited (15-DaCompany Report #2003003013 Age:59 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Amnesia Coordination Abnormal Dehydration Dizziness Drug Toxicity Dysgeusia Gastroenteritis Nausea Tinnitus Tremor Foreign Health Professional Lithium (Lithium) Atorvastatin Mianserin Cimetidine Atenolol Isosorbide Mononitrate Acetylsalicylic Acid Enalapril Omeprazole PS C C C C Manufacturer Route Manufacturer Route C C C C Date:02/03/03ISR Number: 4051537-9Report Type:Expedited (15-DaCompany Report #2003-BP-00500RO Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Vision Blurred Foreign Health Professional Lithium Carbonate Capsules Usp, 300 Mg (Lithium Carbonate) PS ORAL Other Tranxene (Clorazepate Dipotassium) SS ORAL SEE IMAGE 10 MG, PO 22-Aug-2005 Page: 498 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/03ISR Number: 4051539-2Report Type:Expedited (15-DaCompany Report #2003-BP-00499RO Age:61 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Confusional State Fall Foreign Health Professional Lithium Carbonate Capsules Usp, 300 Mg (Lithium Carbonate) PS ORAL Other Tranxene (Clorazepate Dipotassium) SS ORAL Zolpidem (Zolpidem) SS ORAL Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) SS ORAL Risperidone (Risperidone) SS ORAL Manufacturer Route PO 20 MG (10 MG, 2 IN 1 D), PO 10 MG (10 MG, 1 IN 1 D), PO 25 MG (25 MG, 1 IN 1 D), PO 1 MG (1 MG, 1 IN 1 D), PO Date:02/04/03ISR Number: 4052313-3Report Type:Expedited (15-DaCompany Report #2003UW01191 Age:61 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 25 MG QD PO Initial or Prolonged 10 MG BID PO PT Report Source Product Role Manufacturer Route Confusional State Foreign Elavil PS ORAL Fall Consumer Tranxene SS ORAL Other Lithium Carbonate SS Risperidone SS ORAL Zoldipem SS ORAL 1 MG QD PO 10 MG QD PO Date:02/04/03ISR Number: 4052330-3Report Type:Expedited (15-DaCompany Report #2003003832 Age:48 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Agitation Health Lithium (Lithium) PS Anxiety Confusional State Drug Toxicity Dysarthria Gait Disturbance Renal Failure Acute Schizophrenia Professional Olanzapine Atenolol Lorazepam C C C Date:02/05/03ISR Number: 4052100-6Report Type:Direct Age:77 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 400 MG PO PT Drug Level Above Therapeutic 22-Aug-2005 Page: 499 10:48 AM Manufacturer Route ORAL Company Report #CTU 185997 Report Source Product Role Lithium Citrate PS Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/03ISR Number: 4053901-0Report Type:Expedited (15-DaCompany Report #2003002586 Age:51 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Literature Health Professional Lithane (Lithium) Salicylates Mirtazapine PS SS SS Manufacturer Route Manufacturer Route Duration Date:02/07/03ISR Number: 4053968-XReport Type:Expedited (15-DaCompany Report #2003003729 Age:61 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Confusional State Foreign Lithane ( Lithium) PS ORAL Fall Health Professional Amitriptyline Hydrochloride SS ORAL Clorazepate Dipotassium SS ORAL Zolpidem SS ORAL Risperidone SS ORAL 25 MG (DAILY), ORAL 10 MG (BID), ORAL 10 MG (DAILY), ORAL 1 MG (DAILY), ORAL Date:02/07/03ISR Number: 4054205-2Report Type:Expedited (15-DaCompany Report #2003004340 Age: Gender:Male I/FU:I Outcome Dose Other 600 MG PT Report Source Product Role Diarrhoea Therapeutic Response Foreign Health Neurontin(Gabapentin ) PS Manufacturer Route Duration ORAL Increased Professional (DAILY), ORAL Tremor Lithium Lithium Carbonate Date:02/10/03ISR Number: 4054442-7Report Type:Direct Age:19 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening MONTHLY SHOTS Hospitalization DAILY ORALLY Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage PT SS C Company Report #CTU 186302 Report Source Product Role Emotional Disorder Haldol Decanoate PS Grand Mal Convulsion Lithium SS Manufacturer Route ORAL Malaise Mental Disorder Nervous System Disorder Date:02/10/03ISR Number: 4054620-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE03696 Age:21 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Convulsion Drug Interaction Drug Level Increased Foreign Health Professional Leponex/Clozaril (Clozapine/Clozapine ) Tablet PS Grand Mal Convulsion Other 300MG/DAY, ORAL Petit Mal Epilepsy 22-Aug-2005 Page: 500 Manufacturer Route Duration 10:48 AM Hypnorex - Slow Release (Lithium Carbonate) Slow ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Release Tablet SS ORAL 150MG/DAY, ORAL Date:02/10/03ISR Number: 4054639-6Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage PT Company Report #CTU 186314 Report Source Vein Disorder Product Role Clozaril 500ml Daily Eskalith 900 Ml Daily PS Manufacturer Route Manufacturer Route SS Date:02/10/03ISR Number: 4055075-9Report Type:Expedited (15-DaCompany Report #2003004062 Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 250 MG (BID), Initial or Prolonged ORAL PT Report Source Product Role Bradycardia Consumer Lithane (Lithium) PS ORAL Clorazepate Dipotassium SS ORAL Olanzapine SS ORAL Zopiclone SS ORAL 5 MG (DAILY), ORAL 10 MG (DAILY), ORAL 7.5 MG (DAILY), ORAL Date:02/11/03ISR Number: 4054204-0Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040372A Age:52 YR Gender:Female I/FU:I Outcome Dose Other 36000MG PT Report Source Product Role Manufacturer Route Bradycardia Health Quilonum PS Glaxosmithkline ORAL Intentional Misuse Professional Product Role Manufacturer Route Coordination Abnormal Lithium Carbonate PS Diarrhoea Mental Status Changes Nausea Vomiting Quinapril Quetiapine Mirtazapine Gabapentin Atorvastatin Gemfibrozil Omeprazole Tramadol Levothyroxine Amantadine Bupropion Thiothixine Metformin Novolin 70/30 Combivent B-12 C C C C C C C C C C C C C C C C Duration Single dose Somnolence Suicide Attempt Date:02/11/03ISR Number: 4055752-XReport Type:Direct Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300MG PO TID Initial or Prolonged 22-Aug-2005 Page: 501 10:48 AM PT Company Report #CTU 186453 Report Source ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/03ISR Number: 4056197-9Report Type:Expedited (15-DaCompany Report #2003004700 Age: Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Confusional State Drug Level Decreased Consumer Lithium (Lithium) PS Manufacturer Route Manufacturer Route Duration Date:02/11/03ISR Number: 4056523-0Report Type:Expedited (15-DaCompany Report #PHBS2003JP01119 Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Fall Forearm Fracture Foreign Literature Health Professional Melleril (Thioridazine Hydrochloride) Tablet PS Other Levomepromazine Hydrochloride (Levomepromazine Hydrochloride) SS Lithium Carbonate (Lithium Carbonate) SS Prothiaden (Dosulepin) SS Zopiclone (Zopiclone) SS Tiapride Hydrochloride (Tiapride Hydrochloride) SS Biperiden Hydrochloride (Biperiden Hydrochloride) SS 30 MG/D, ORAL 5 MG/D 600 MG/D 75 MG/D 30 MG/D 25 MG/D 3 MG/D ORAL Date:02/12/03ISR Number: 4057228-2Report Type:Expedited (15-DaCompany Report #030130-PM0024-00 Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Intentional Misuse Rhabdomyolysis Suicide Attempt Foreign Health Professional Tranxene (Clorazepate Dipotassium) Tablets PS ORAL Other Risperedone Tablets SS ORAL Olanzapine Tablets SS ORAL Lithium Carbonate Tablets SS ORAL Levomepromazine Tablets SS ORAL 5 MG, P.O QD P.O. P.O. P.O. P.O. Date:02/12/03ISR Number: 4057235-XReport Type:Expedited (15-DaCompany Report #030109-PM0019-01 Age:55 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 5 MG, P.O. QD PT Report Source Product Role Manufacturer Route Bradycardia Foreign Health Professional Tranxene (Clorazepate Dipotassium) PS ORAL Other Lithium Carbonate SS ORAL Olanzapine SS ORAL YR 250 MG, P.O., BID YR 10 MG, P.O., QD 22-Aug-2005 Page: 502 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zopiclone SS ORAL 7.5 MG, P.O., QD YR Date:02/13/03ISR Number: 4057377-9Report Type:Expedited (15-DaCompany Report #PHBS2003JP01358 Age:70 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Condition Aggravated Drug Interaction Foreign Health Voltaren (Diclofenac Sodium) Suppository PS Gait Disturbance Major Depression Professional Limas (Lithium Carbonate) Hypnotics And Sedatives Antianxietics Manufacturer Route Manufacturer Route Duration RECTAL RECTAL SS C C Date:02/13/03ISR Number: 4057982-XReport Type:Expedited (15-DaCompany Report #PHBS2003JP01119 Age:72 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Fall Forearm Fracture Foreign Literature Health Professional Melleril (Thioridazine Hydrochloride) Tablet PS Other Levomepromazine Hydrochloride (Levomepromazine Hydrochloride) SS Lithium Carbonate (Lithium Carbonate) SS Prothiaden (Dosulepin) SS Zopiclone (Zopiclone) SS 30 MG/D, ORAL 5 MG/D, 600 MG/D, 75 MG/D, 30 MG/D, ORAL Tiapride Hydrochloride (Tiapride Hydrochloride) SS Biperiden Hydrochloride (Diperiden Hydrochloride) SS 25 MG/D, 3 MG/D, Date:02/14/03ISR Number: 4056116-5Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0038001A Age:63 YR Gender:Male I/FU:F Outcome PT Dose Duration Other Akathisia 450MG Unknown 93 DAY Constipation 60MG per day 138 DAY Oedema Peripheral 250MG per day 3 DAY Pain 400MG per day 60 DAY Serotonin Syndrome 6MG per day Suicide Attempt 30DROP per day 24 DAY 6MG per day 82 DAY 22 DAY 22-Aug-2005 Page: 503 10:48 AM Report Source Product Role Manufacturer Route Health Quilonum Retard PS Glaxosmithkline ORAL Professional Remeron SS ORAL Tramal SS ORAL Celebrex C ORAL Arelix C ORAL Baldrian C ORAL Sirdalud C ORAL Dipiperon C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/03ISR Number: 4056806-4Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Psoriasis Date:02/19/03ISR Number: 4057489-XReport Type:Direct Age:41 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage Company Report #CTU 186706 PT Product Role Lithium PS Manufacturer Route Manufacturer Route Manufacturer Route Company Report #CTU 186825 Report Source Affective Disorder Blood Creatinine Increased Brain Damage Clonic Convulsion Condition Aggravated Convulsion Coordination Abnormal Dialysis Difficulty In Walking Drug Level Increased Loss Of Consciousness Mental Status Changes Oral Intake Reduced Tremor Urinary Tract Infection Product Role Lithium PS Date:02/19/03ISR Number: 4059118-8Report Type:Expedited (15-DaCompany Report #LBID00203000023 Age:48 YR Gender:Male I/FU:F Outcome Dose Duration Death Hospitalization 300 MG BID PO Initial or Prolonged PT Report Source Product Role Depressed Mood Diabetes Insipidus Health Professional Lithobid (Lithium Carbonate) PS Lethargy Oedema Peripheral Pneumonia Depakote (Valproate Semisodium) Risperdal (Risperidone) Vitamin D (Vitamin C C ORAL D) Multivitamins (Multivitamins) Actonel (Actonel) Warfarin (Warfarin) C C C C Date:02/19/03ISR Number: 4059120-6Report Type:Expedited (15-DaCompany Report #LBID00203000351 Age:18 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY PO PT Report Source Product Role Nausea Suicide Attempt Health Professional Lithobid (Lithium Carbonate) PS Vomiting 22-Aug-2005 Page: 504 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/03ISR Number: 4060308-9Report Type:Expedited (15-DaCompany Report #2003001969 Age:62 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 80 MG (BID), Initial or Prolonged ORAL Other 600 MG PT Report Source Product Role Blood Calcium Abnormal Foreign Geodon (Ziprasidone) PS ORAL Circulatory Collapse Health Epilepsy Professional Lithium SS ORAL Postictal State Company Manufacturer Route (DAILY), ORAL Representative Date:02/21/03ISR Number: 4058419-7Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0397122A Age:42 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 3TAB See Initial or Prolonged dosage text PT Report Source Product Role Manufacturer Route Aphasia Consumer Lithium PS Glaxosmithkline ORAL Product Role Manufacturer Route Lithium Carbonate 300mg PS Hypersomnia Incoherent Lethargy Medication Error Pneumonia Speech Disorder Date:02/21/03ISR Number: 4059140-1Report Type:Direct Age:67 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300MG BID PT Decreased Activity Drug Level Increased Mental Status Changes ORAL Company Report #CTU 187077 Report Source ORAL Date:02/21/03ISR Number: 4062129-XReport Type:Expedited (15-DaCompany Report #EMADSS2001005486 Age:48 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening PT Report Source Product Role Blood Creatine Phosphokinase Increased Dysphagia Foreign Study Health Risperidone (Unspecified) (Risperidone) PS Headache Neuroleptic Malignant Professional Topiramate (Capsule) (Topiramate) SS Placebo (Placebo) SS Lithium (Lithium) SS Lorazepam Chloral Hydrate (Chloral Hydrate) Diazepam (Diazepam) Olanzapine (Olanzapine) Senna (Senna) Lactulose (Lactulose) Haloperidol (Haloperidol) Lithium Carbonate (Lithium Carbonate) C Manufacturer Route SEE IMAGE 3 CAP, DAILY, Syndrome ORAL Respiratory Failure 3 CAP, DAILY, Speech Disorder ORAL DATA UNSPECIFIED 22-Aug-2005 Page: 505 10:48 AM C C C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/03ISR Number: 4064815-4Report Type:Expedited (15-DaCompany Report #PHBS2002JP14758 Age:69 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Abnormal Behaviour Akathisia Blood Creatine Foreign Health Professional Parlodel (Bromocriptine Mesilate) PS ORAL Phosphokinase Increased Hyperhidrosis Other Limas(Lithium Carbonate) SS ORAL Lodopin(Zotepine) SS ORAL Manufacturer Route SEE IMAGE 400 MG/DAY, Hypertension ORAL Parkinsonism 50 MG/DAY, ORAL Inhibace (Cilazapril) Coniel (Benidipine Hydrochloride) Barnetil(Sultopride) SS Roche SS C ORAL 800 MG/DAY, ORAL Amoban Benzalin Hirnamin Pyrethia C C C C Date:02/25/03ISR Number: 4059971-8Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0383288A Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization 300MG See Initial or Prolonged dosage text PT Report Source Product Role Manufacturer Blood Cholesterol Consumer Eskalith PS Glaxosmithkline Lithium Estrogen SS C Glaxosmithkline Increased Diarrhoea Drug Level Increased Drug Toxicity Initial Insomnia Middle Insomnia Route Parathyroid Disorder Renal Impairment Seasonal Affective Disorder Surgery Weight Decreased Date:02/25/03ISR Number: 4062004-0Report Type:Direct Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300 MG PO QD Initial or Prolonged 300 MG PO QD 22-Aug-2005 Page: 506 10:48 AM PT Company Report #CTU 187383 Report Source Product Role Manufacturer Route Blood Creatinine Irbesartan PS ORAL Increased Lithium SS ORAL Blood Urea Increased Confusional State Coordination Abnormal Drug Toxicity Lethargy Tremor Irbesartan Hydrochlorothiazide Tegretol Lithium Olanzapine Albuterol Advair Mvi C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/03ISR Number: 4060817-2Report Type:Expedited (15-DaCompany Report #WAES 0302CHE00024 Age:52 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 4 PT Report Source Brain Oedema Drug Interaction Drug Level Increased Nephrogenic Diabetes Insipidus Product Role Manufacturer Route Moduretic Lithium Carbonate Valproate Sodium Haloperidol Amoxicillin Trihydrate And Clavulanate Potassium PS SS C C Merck & Co., Inc ORAL ORAL ORAL ORAL C ORAL Methotrimeprazine Risperidone Tizanidine Flavoxate Hydrochloride Oxerutins C C C ORAL ORAL ORAL C C ORAL ORAL DAY Date:02/26/03ISR Number: 4061851-9Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Company Report #CTU 187493 Report Source Confusional State Drug Toxicity Tremor Product Role Lithium Benztropine Fluphenazine Glipizide Paroxetine Trazodone PS C C C C C Manufacturer Route Manufacturer Route Date:02/26/03ISR Number: 4066629-8Report Type:Expedited (15-DaCompany Report #2003004062 Age:55 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 250 MG (BID), Initial or Prolonged ORAL PT Report Source Product Role Bradycardia Consumer Lithane (Lithium) PS Health Professional Clorazepate ORAL Dipotassium SS ORAL Olanzapine SS ORAL Zopiclone SS ORAL 5 MG (DAILY), ORAL 10 MG (DAILY), ORAL 7.5 MG (DAILY), ORAL Date:02/26/03ISR Number: 4066877-7Report Type:Expedited (15-DaCompany Report #030130-PM0024-01 Age:48 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Intentional Misuse Rhabdomyolysis Suicide Attempt Foreign Health Professional Tranxene (Clorazepate Dipotassium) Tablets PS ORAL Other Risperedone Tablets SS ORAL Olanzapine Tablets SS ORAL Lithium Carbonate Tablets SS ORAL Levomepromazine Tablets SS ORAL 5 MG, P.O. QD P.O. P.O. P.O. P.O. 22-Aug-2005 Page: 507 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4062477-3Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0398148A Age:13 YR Gender: I/FU:I Outcome Dose Duration Hospitalization 1200MG Per Initial or Prolonged day YR PT Report Source Product Role Manufacturer Route Myositis Health Lithium PS Glaxosmithkline ORAL Risperdal Cogentin C C Manufacturer Route Professional Date:02/28/03ISR Number: 4067555-0Report Type:Expedited (15-DaCompany Report #EMADSS2003001581 Age:52 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Agitation Brain Oedema Dehydration Foreign Health Professional Haldol (10 Mg Tablet) (Haloperidol) PS ORAL Priadel (Lithium Carbonate) SS ORAL Nephrogenic Diabetes Insipidus Depakine Chrono (Ergenyl Chrono) SS ORAL Oedema Peripheral Pitting Oedema Moduretic (Moduretic) SS ORAL Somnolence Augmentin (Clavulin) SS ORAL Therapeutic Agent Toxicity Risperdal (Risperidone) Nozinan (Levomepromazine) Sirdalud (Tizanidine Hydrochloride) Venoruton 10 MG, DAILY, Depressed Level Of ORAL Consciousness Drug Interaction 800 MG, Miosis DAILY, ORAL SEE IMAGE 2 TABLE, WEEK Pneumonia (S), ORAL ORAL C C C (Troxerutin) Urispas(Flavoxate Hydrochloride) C C Date:02/28/03ISR Number: 4067961-4Report Type:Expedited (15-DaCompany Report #2003002655 Age:27 YR Gender: I/FU:I Outcome Dose Death ORAL PT Report Source Product Role Manufacturer Route Completed Suicide Literature Lithium(Lithium) PS ORAL Intentional Misuse Health Clonazepam SS ORAL Professional Metformin SS Duration ORAL ORAL Date:02/28/03ISR Number: 4067962-6Report Type:Expedited (15-DaCompany Report #2003002625 Age:47 YR Gender: I/FU:I Outcome Dose Duration Death ORAL Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 508 10:48 AM PT Report Source Product Role Confusional State Literature Lithium (Lithium) PS Coordination Abnormal General Physical Health Deterioration Hypotension Mental Status Changes Renal Failure Tachycardia Health Professional Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4067963-8Report Type:Expedited (15-DaCompany Report #2003002630 Age:38 YR Gender: I/FU:I Outcome Dose Death ORAL PT Report Source Product Role Manufacturer Route Cardio-Respiratory Arrest Literature Lithium(Lithium) PS ORAL Completed Suicide Intentional Misuse Health Professional Venlafaxine(Venlafax ine) SS ORAL Benzodiazepine(Benzo diazepine Derivatives) SS ORAL Duration ORAL ORAL Date:02/28/03ISR Number: 4067964-XReport Type:Expedited (15-DaCompany Report #2003002629 Age:54 YR Gender: I/FU:I Outcome Dose Death ORAL PT Report Source Product Role Manufacturer Route Completed Suicide Literature Lithium(Lithium) PS ORAL Drug Level Increased Health Professional Fluvastatin (Fluvastatin) SS ORAL Rosiglitazone (Rosiglitazone) SS ORAL Duration ORAL ORAL Date:03/03/03ISR Number: 4064797-5Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040372A Age:52 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 36000MG Initial or Prolonged Single dose PT Ankle Fracture Bradycardia Circulatory Collapse Fall Hyporeflexia Hypotension Intentional Misuse Report Source Product Role Manufacturer Route Quilonum PS Glaxosmithkline ORAL Somnolence Suicide Attempt Date:03/03/03ISR Number: 4069172-5Report Type:Expedited (15-DaCompany Report #2003002626 Age:53 YR Gender:Unknown I/FU:I Outcome Dose Death PT Report Source Product Role Drug Level Above Therapeutic Literature Health Professional Lithane (Lithium) PS Manufacturer Route Manufacturer Route Duration Date:03/03/03ISR Number: 4069215-9Report Type:Expedited (15-DaCompany Report #2003002628 Age:46 YR Gender: I/FU:I Outcome Dose Death 22-Aug-2005 Page: 509 PT Report Source Product Role Completed Suicide Literature Health Professional Lithane (Lithium) Sertraline (Sertraline) Vicodin PS Duration 10:48 AM SS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/03ISR Number: 4069819-3Report Type:Expedited (15-DaCompany Report #B0292616A Age:11 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Blood Cholesterol Increased Blood Ph Decreased Blood Pressure Diastolic Literature Health Professional Eskalith (Formulation Unknown)(Lithium Carbonate) PS Topiramate Risperidone C C Manufacturer Route Manufacturer Route Duration 300 MG / Decreased TWICE PER DAY Glomerulonephritis Focal / Haematuria Nephrotic Syndrome Proteinuria White Blood Cell Count Decreased Date:03/03/03ISR Number: 4069824-7Report Type:Expedited (15-DaCompany Report #2003003832 Age:48 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 600 MG(BID), Initial or Prolonged ORAL PT Report Source Product Role Anion Gap Increased Health Lithium (Lithium) PS ORAL Anxiety Professional Blood Alkaline Olanzapine SS ORAL Phosphatase Increased Blood Bicarbonate Decreased Blood Glucose Increased Blood Thyroid Stimulating Hormone Increased Depression Dysarthria Gait Disturbance Haematocrit Decreased Lymphocyte Count Decreased Neutrophil Count Increased Atenolol Lorazepam C C 20 MG, ORAL Platelet Disorder Red Blood Cell Count Decreased Renal Failure Acute Schizophrenia Therapeutic Agent Toxicity Date:03/03/03ISR Number: 4069825-9Report Type:Expedited (15-DaCompany Report #2003002627 Age:57 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Drug Interaction Medication Error Literature Health Professional Lithane (Lithium) PS Manufacturer Duration Date:03/04/03ISR Number: 4065482-6Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0293775A Age:48 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 510 10:48 AM PT Intentional Misuse Rhabdomyolysis Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Dose Report Source Product Role Manufacturer Health Professional Lithium Carbonate Tranxene PS SS Glaxosmithkline Risperidone Olanzapine Levomepromazine SS SS SS Route Duration ORAL 5MG Four times per day Date:03/04/03ISR Number: 4067148-5Report Type:Direct Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization BY MOUTH Initial or Prolonged PHYSICIAN PT ORAL Company Report #CTU 187911 Report Source Mental Status Changes Product Role Lithium PS Manufacturer Route ORAL Date:03/05/03ISR Number: 4066297-5Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040521A Age:62 YR Gender:Female I/FU:I Outcome Dose Duration Other 900MG per day PT Report Source Product Role Manufacturer Route Drug Level Increased Health Quilonum Retard PS Glaxosmithkline ORAL Personality Change Renal Failure Tremor Professional Role Manufacturer Route Date:03/05/03ISR Number: 4071231-8Report Type:Expedited (15-DaCompany Report #LBID00202002402 Age:32 YR Gender:Male I/FU:F Outcome Dose Disability PT Report Source Product Blindness Transient Consumer Lithobid (Lithium Duration Deafness Carbonate) PS Diarrhoea Ear Pain Migraine Tinnitus Vision Blurred Risperdal (Risperidone) C ORAL SEE IMAGE Date:03/06/03ISR Number: 4066845-5Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040372A Age:52 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 36000MG Initial or Prolonged Single dose PT Report Source Product Role Manufacturer Route Ankle Fracture Health Quilonum PS Glaxosmithkline ORAL Bradycardia Professional Circulatory Collapse Fall Hyporeflexia Hypotension Intentional Misuse Somnolence Suicide Attempt 22-Aug-2005 Page: 511 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/03ISR Number: 4072062-5Report Type:Expedited (15-DaCompany Report #2003008811 Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 250 MG (BID), Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Bradycardia Consumer Lithane (Lithium) PS ORAL Zopiclone SS ORAL Clorazepate Dipotassium SS ORAL Olanzapine SS ORAL 7.5 MG (QD), ORAL 5 MG (QD), ORAL 10 MG (QD), ORAL Date:03/07/03ISR Number: 4069512-7Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300 MG TID Initial or Prolonged ORAL PT Aphasia Company Report #CTU 188183 Report Source Product Role Lithium 300 Mg PS ORAL Micardis Hct 80 /12.5 Mg SS ORAL Synthroid Norvasc Calcium Allegra Prn C C C C Manufacturer Route Dysarthria Insomnia Lethargy 80/12.5 MG QD Mental Impairment ORAL Oral Intake Reduced Somnolence Tremor Date:03/10/03ISR Number: 4068765-9Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040581A Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Alopecia Nail Disorder Therapeutic Agent Toxicity Date:03/11/03ISR Number: 4072835-9Report Type:Direct Age:48 YR Gender:Male I/FU:I Outcome Dose Other Report Source PT Product Role Manufacturer Route Quilonum Retard PS Glaxosmithkline ORAL Product Role Manufacturer Route Lithium Carbonate Elavil PS C Company Report #CTU 188501 Report Source Duration Flushing Date:03/11/03ISR Number: 4074694-7Report Type:Expedited (15-DaCompany Report #03P-151-0212144-00 Age:52 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 512 10:48 AM PT Agitation Brain Oedema Dehydration Depressed Level Of Consciousness Drug Interaction Drug Level Increased Miosis Nephrogenic Diabetes Insipidus FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Renal Failure Acute Schizophrenia Dose Report Source Product Role Manufacturer Route Foreign Health Professional Other Depakine Chrono Tablets (Depakene) (Sodium Valproate/Valproic Acid) (Sodium PS ORAL Lithium Carbonate SS ORAL Haloperidol SS ORAL Moduretic SS ORAL Clavulin SS ORAL Levomepromazine Risperidone Tizanidine Hydrochloride Flavoxate Hydrochloride Troxerutin C C Duration Somnolence Tachypnoea SEE IMAGE 400 MG, 2 IN 1 D, ORAL 5 MG, 2 IN 1 D, PER ORAL 1 TABLET, 2 IN 1 WK, ORAL ORAL C C C Date:03/12/03ISR Number: 4075266-0Report Type:Expedited (15-DaCompany Report #B0294000A Age:69 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Arthralgia Clonic Convulsion Depressed Level Of Consciousness Diabetes Mellitus Non-Insulin-Dependent Drug Interaction Drug Toxicity Foreign Literature Health Professional Eskalith (Lithium Carbonate) Diclofenac (Diclofenac) Haloperidol Role PS SS C Manufacturer Route Dyskinesia Electroencephalogram Abnormal Insomnia Psychomotor Retardation Tremor Date:03/12/03ISR Number: 4075280-5Report Type:Expedited (15-DaCompany Report #B0292874A Age: Gender:Female I/FU:I Outcome Other 22-Aug-2005 Page: 513 PT Apgar Score Low Cardiomegaly Complications Of Maternal Exposure To Therapeutic Drugs Drug Level Increased Hyperbilirubinaemia Neonatal Hypoglycaemia Neonatal Maternal Drugs Affecting Foetus Nephrogenic Diabetes Insipidus 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oliguria Patent Ductus Arteriosus Polyuria Dose Report Source Product Role Foreign Literature Lithium Salt (Lithium Salt) PS Labetalol Hydrochloride Betamethasone C C Manufacturer Route Manufacturer Route Duration TRANSPLACENTAL Pregnancy Pregnancy Induced TRANSPLACENTA Hypertension Health RY Premature Baby Premature Rupture Of Membranes Prolonged Labour Respiratory Disorder Neonatal Urine Osmolarity Decreased Weight Decrease Neonatal Professional Date:03/12/03ISR Number: 4075294-5Report Type:Expedited (15-DaCompany Report #B0293592A Age:78 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Aortic Valve Stenosis Bundle Branch Block Left Cardiac Failure Cardiac Murmur Cardiomyopathy Drug Interaction Drug Toxicity Electrocardiogram Qrs Complex Shortened Hypertension Prescribed Overdose Pulmonary Hypertension Renal Impairment Ventricular Extrasystoles Foreign Literature Health Professional Lithium Salt (Formulation Unknown) Imipramine (Formulation Unknown) (Imipramine) Amineptine Hydrochloride (Formulation Unknown) (Amineptine Hydrochloride) Methotrimeprazine (Formulation Unknown) (Methotrimeprazine) Lorazepam (Formulation Unknown) (Lorazepam) Role PS SS SS SS SS Date:03/13/03ISR Number: 4071168-4Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040613A Age:64 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 33 DAY 26 PT Report Source Product Role Manufacturer Route Dyskinesia Glossitis Quilonum Retard Trevilor PS SS Glaxosmithkline ORAL ORAL Glossodynia Taxilan SS ORAL Trismus Tafil Isoptin C C ORAL Liviella C ORAL L -Thyroxine C Noctamid C DAY UNKNOWN 240MG per day 1TAB Per day UNKNOWN Glaxosmithkline .075MG per day 1MG per day 22-Aug-2005 Page: 514 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/03ISR Number: 4071169-6Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040615A Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 1350MG per Initial or Prolonged day 4 YR PT Report Source Blood Creatinine Product Role Manufacturer Route Quilonum Retard PS Glaxosmithkline ORAL Tegretal C Increased Confusional State ORAL 400MG per day Convulsion Drug Level Increased Meningioma Nervous System Disorder Restlessness Sleep Disorder Therapeutic Agent Toxicity Date:03/13/03ISR Number: 4076132-7Report Type:Expedited (15-DaCompany Report #PHBS2003JP01358 Age:70 YR Gender:Male I/FU:F Outcome Dose Other RECTAL PT Report Source Product Role Depression Drug Interaction Foreign Health Voltaren(Diclofenac Sodium) Suppository PS Gait Disturbance Major Depression Professional Other Limas(Lithium Carbonate) Hypnotics And Sedatives Anxiolytics Manufacturer Route Manufacturer Route Duration RECTAL SS C C Date:03/14/03ISR Number: 4076972-4Report Type:Expedited (15-DaCompany Report #2003-DE-00746GD Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG PT Report Source Product Role Diarrhoea Gaze Palsy Foreign Literature Lithium Carbonate (Lithium Carbonate) PS Mental Disorder Parkinsonism Pyrexia Therapeutic Agent Toxicity Date:03/17/03ISR Number: 4077741-1Report Type:Expedited (15-DaCompany Report #200310852EU Age:68 YR Gender:Female I/FU:I Outcome Dose Duration Death Other 1.2 G/DAY PO 3 WK PT Report Source Product Role Death Drug Toxicity Foreign Metronidazole (Flagyl "Aventis" PS ORAL Lithium Sulfate (Lithionit) SS ORAL Hypernatraemia 166 MG/DAY PO Venlafaxine Hydrochloride (Efexor Depot) Pivampicillin Hydrochloride (Pondocillin) 22-Aug-2005 Page: 515 10:48 AM C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/03ISR Number: 4077845-3Report Type:Expedited (15-DaCompany Report #LBID00203000351 Age:15 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged DAILY PO PT Report Source Product Role Drug Level Increased Nausea Health Professional Lithobid (Lithium Carbonate) PS Manufacturer Route ORAL Suicide Attempt Vomiting Date:03/19/03ISR Number: 4074238-XReport Type:Expedited (15-DaCompany Report #AT-GLAXOSMITHKLINE-B0295035A Age:37 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening 450MG Twice Hospitalization per day 13 DAY Initial or Prolonged 30MG per day 13 DAY 13 PT Report Source Product Role Manufacturer Route Apnoea Health Quilonorm PS Glaxosmithkline ORAL Blood Potassium Decreased Professional Cardiac Arrest Zyprexa C ORAL Self-Medication Rivotril C ORAL Shock Augmentin Pantoloc C C Akineton C ORAL Depakine Nubain C C ORAL Tricyclic Antidepressant Scopolamin C C DAY Glaxosmithkline ORAL ORAL 40MG per day 2MG per day SUBCUTANEOUS SUBCUTANEOUS 2 DAY 20MG per day .5ML per day 1 1 DAY DAY Date:03/19/03ISR Number: 4074255-XReport Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0294710A Age: Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Other 40MG per day Akathisia Health Seroxat PS Glaxosmithkline ORAL Drug Interaction Professional Lithium SS Glaxosmithkline ORAL Thyroxine Risperidone C C Glaxosmithkline ORAL Product Role Manufacturer Route Lithium 300mg And 150mg PS ORAL Resperdal 1mg And .5mg SS ORAL 1.2G per day Dysphasia Date:03/19/03ISR Number: 4076524-6Report Type:Direct Age:10 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 450MG TWO DAY Required ORAL Intervention to Prevent Permanent 1.5MG THREE Impairment/Damage TIMES DAY PT Aphasia Blood Pressure Increased Company Report #CTU 189074 Report Source Dizziness Dyskinesia Dyspnoea Fatigue Headache ORAL Memory Impairment Productive Cough Speech Disorder Tremor Date:03/19/03ISR Number: 4078502-XReport Type:Expedited (15-DaCompany Report #LBID00203000674 Age:51 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 516 10:48 AM PT Abdominal Adhesions Abdominal Pain Anaemia FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Diarrhoea Drug Toxicity Extramedullary Report Source Product Role Haemopoiesis Kidney Enlargement Literature Health Lithium Carbonate (Lithium Carbonate) PS Renal Cell Carcinoma Stage Unspecified Renal Failure Acute Thrombocythaemia Professional Manufacturer Route Duration ORAL DAILY PO Date:03/19/03ISR Number: 4078517-1Report Type:Expedited (15-DaCompany Report #200300783S Age:46 YR Gender:Female I/FU:I Outcome Dose Death 10 MG 200 MG 800MG 4MG 100MG 20MG 25MG PT Report Source Product Role Manufacturer Route Sudden Death Health Professional (Myslee) Zolpidem Tablet 10 Mg PS (Dogmatyl) Sulpiride Tablet 100 Mg SS (Limas) Lithium Carbonate Tablet 200 Mg SS ORAL (Artane) Trihexyphenidyl Hydrochloride Tablet 2mg SS ORAL (Toledomin) Milnacipran Hydrochloride Tablet SS ORAL (Tetramide) Mianserin Hydrochloride Tablet SS (Contmin) Chlorpromazine Tablet 25mg SS Duration 18 88 2 21 7 88 21 ORAL MON MON YR MON MON MON MON (Silece) 2MG 150MG 61 11 Flunitrazepam Tablet 2mg SS (Seroquel) Quetiapine Fumarate Tablet SS MON MON Date:03/19/03ISR Number: 4078927-2Report Type:Expedited (15-DaCompany Report #PHBS2003FI02658 Age:45 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 250 MG/D, PT Report Source Product Role Anorexia Difficulty In Walking Foreign Health Lamisil(Terbinafine Hydrochloride) PS Drug Interaction Professional Drug Level Increased Muscle Twitching Tremor Weight Decreased Other ORAL 22-Aug-2005 Page: 517 10:48 AM Lito(Lithium Carbonate) Truxal (Chlorprothixene Hydrochloride) SS C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/03ISR Number: 4078933-8Report Type:Expedited (15-DaCompany Report #B0294723A Age: Gender:Male I/FU:I Outcome PT Dose Duration Required Goitre Congenital Intervention to Maternal Drugs Affecting Prevent Permanent Foetus Impairment/Damage TRANSPLACENTAL TRANSPLACENTA Report Source Product Role Foreign Literature Health Professional Lithium Salt (Formulation Unknown) (Lithium Salt) PS Manufacturer Route Manufacturer Route RY Date:03/21/03ISR Number: 4082179-7Report Type:Expedited (15-DaCompany Report #L03-NLD-01012-01 Age:49 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200 MG QD Initial or Prolonged PT Report Source Product Role Cerebellar Syndrome Foreign Carbamazepine PS Drug Level Above Therapeutic Literature Other Lithium Trifluperidol SS SS 1.5 MG QD Lobar Pneumonia Pneumonia Streptococcal Therapeutic Agent Toxicity Date:03/24/03ISR Number: 4076710-5Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0294907A Age: Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Tremor 20MG Per day 56 DAY Initial or Prolonged 330MG Per day 12 DAY 5MG Per day 3MG Per day 50 Report Source Product Role Manufacturer Route Deroxat PS Glaxosmithkline ORAL Lithium Sulphate SS ORAL Zyprexa SS ORAL Temesta C ORAL DAY Date:03/25/03ISR Number: 4077593-XReport Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040688A Age:27 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Quilonum Trevilor Zyprexa PS SS SS Glaxosmithkline ORAL ORAL ORAL Duration Intentional Misuse Suicide Attempt 400MG per day Date:03/25/03ISR Number: 4082240-7Report Type:Direct Age:52 YR Gender:Male I/FU:I Outcome 22-Aug-2005 Page: 518 PT Cardiac Disorder Chills Coronary Artery Occlusion Diabetes Mellitus Discomfort Dyspnoea Eye Pain General Physical Health Deterioration Headache Malaise Muscular Weakness Palpitations Therapeutic Agent Toxicity 10:48 AM Company Report #CTU 189077 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Treatment Noncompliance Tremor Report Source Dose 5 Product Role Eskalith 450 Cr PS Manufacturer Route Manufacturer Route Duration YR Date:03/26/03ISR Number: 4083862-XReport Type:Expedited (15-DaCompany Report #2003011623 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 6 MG (TID) Other 20 MG PT Report Source Product Role Anger Anorexia Consumer Navane (Capsule) (Tiotixene) PS Geodon (Ziprasidone) SS Lithane (Lithium) Valdecoxib Celecoxib Haloperidol Calcium Ascorbate Cyanocobalamin Pyridoxine Hydrochloride Zinc Picolinate Fluphenazine Hydrochloride Methylphenidate Hydrochloride Ketoconazole Levothyroxine Sodium Estrogens Conjugated Clobetasol Propionate Rofecoxib Tocopherol Clarithromycin Entex Mesoridazine Risperidone Olanzapine Valproate Semisodium SS SS SS SS C C Arthritis Asthenia (WEEKLY) Bladder Disorder Blood Cholesterol Blood Pressure Blood Pressure Systolic Cough Dizziness Dyspepsia Fatigue Feeling Abnormal Frequent Bowel Movements Gait Disturbance Headache Heart Rate Increased Incontinence Increased Appetite Mental Disorder Muscle Spasms Pain In Extremity Paranasal Sinus Hypersecretion Physical Examination Abnormal Pollakiuria Pyrexia Schizoaffective Disorder Screaming C C C C C C C C C C C C C C C C Sleep Disorder Stress Suicidal Ideation Urinary Retention Weight Fluctuation Omeprazole Nizatidine Thiamine Hydrochloride C C C Date:03/26/03ISR Number: 4083975-2Report Type:Expedited (15-DaCompany Report #2003AP01246 Age:46 YR Gender:Female I/FU:I Outcome Dose Duration Death 50 MG TID, PO PT Report Source Product Role Manufacturer Route Cardiovascular Disorder Foreign Seroquel PS ORAL Sudden Death Health Limas SS ORAL Professional Artane SS ORAL Other Dogmatyl SS ORAL Toledomin SS ORAL Tetramide SS ORAL Contomin SS ORAL Silece SS ORAL Zolpidem SS ORAL 200 MG QID PO 2 MG BID PO 100 MG BID PO 50 MG PO 20 MG QD PO 25 MG QD PO 2 MG QD PO 10 MG QD PO 22-Aug-2005 Page: 519 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/26/03ISR Number: 4084136-3Report Type:Expedited (15-DaCompany Report #NALB20030001 Age:42 YR Gender:Male I/FU:I Outcome PT Dose Duration Life-Threatening Bipolar Disorder SUBCUTANEOUS 20 MG ONCE Hospitalization Bradycardia SUBCU Initial or Prolonged Cardiac Arrest SUBCUTANEOUS 0.5 ML ONCE Required Condition Aggravated SUBCU Intervention to Drug Interaction 30 MG PO Prevent Permanent Infection 900 MG PO Impairment/Damage Inflammation 10 MG PO Mania 40 MG Report Source Product Role Manufacturer Route Foreign Nalbuphine PS Scopolamine SS Olanzapine SS ORAL Lithium Carbonat SS ORAL Clonazepam SS ORAL Pantoprazol SS Biperidine SS Valproinat SS Olanzapine Lithium Carbonat Clonazepam Amoxicillin/Clavulan at Valproinat Amoxicillin/Clavulan at Valproinat C C C Health Professional 2 MG 3000 MG C C C C Date:03/28/03ISR Number: 4080305-7Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0296034A Age:61 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Drug Eruption 600MG per day 42 DAY Initial or Prolonged Erythema Haemodialysis Skin Test Positive Report Source Product Role Manufacturer Lithium Carbonate PS Glaxosmithkline Chlorpromazine Levomepromazine Risperidone C C C Glaxosmithkline Route Swelling Zonisamide Biperiden Hydrochloride Pollen Extract Vegetamin A Amobarbital Bromovalerylurea Sairei-To C C C C C C C Date:03/28/03ISR Number: 4080306-9Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040521A Age:62 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 900MG per day Initial or Prolonged PT Drug Level Increased Report Source Product Role Manufacturer Route Quilonum Retard PS Glaxosmithkline ORAL Personality Change Renal Failure Tremor Date:03/31/03ISR Number: 4080840-1Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0295537A Age:60 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 520 10:48 AM PT Bipolar I Disorder Cerebral Ventricle Dilatation Delirium Depressed Level Of FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Consciousness Disorientation Disturbance In Attention Drug Interaction Dose 41 Report Source Product Role Manufacturer Dysarthria Lithium Carbonate PS Glaxosmithkline Grandiosity Hallucination, Visual Insomnia Irritability Logorrhoea Psychomotor Hyperactivity Speech Disorder Therapeutic Agent Toxicity Haloperidol C Route Duration DAY Date:03/31/03ISR Number: 4087386-5Report Type:Expedited (15-DaCompany Report #2003-DE-01061GD (0) Age: Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Therapeutic Agent Toxicity Literature Lithium Carbonate (Lithium Carbonate) PS Manufacturer Route Duration Date:04/01/03ISR Number: 4082336-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12216925 Age:62 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Hyponatraemia Polydipsia Date:04/01/03ISR Number: 4084982-6Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Trazodone Hcl Tabs Lithium Aminophylline Benzhexol Hcl Haloperidol Acetaminophen PS SS C C C C Apothecon ORAL ORAL Role Manufacturer Route Company Report #CTU 189959 Report Source Product Hospitalization 2 TABS TID Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Dysarthria Lithium 300mg PS Mental Status Changes Lorazepam Clonazepam Divalproex Benzotropine C C C C Date:04/01/03ISR Number: 4085017-1Report Type:Direct Age:85 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300MG PO QHS Initial or Prolonged 22-Aug-2005 Page: 521 10:48 AM PT Aggression Confusional State Fatigue Company Report #CTU 189952 Report Source Product Role Lithium Carbonate PS Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/03ISR Number: 4085925-1Report Type:Direct Age:77 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 300MG PO QAM Initial or Prolonged AND 600MG PO PT Company Report #CTU 189934 Report Source Dehydration Product Role Lithium Carbonate PS Manufacturer Route ORAL Sinus Bradycardia QHS Date:04/01/03ISR Number: 4085931-7Report Type:Direct Age:65 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 450MG PO QHS PT Company Report #CTU 189941 Report Source Product Role Asthenia Blood Urea Lithium Carbonate 450mg PS Drug Level Increased Lethargy Lithium Carbonate 300mg SS Lisinopril Spironolactone C C Manufacturer Route 300MG PO QD Date:04/03/03ISR Number: 4084101-6Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040582A Age:62 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 450MG See Initial or Prolonged dosage text PT Report Source Product Role Manufacturer Route Coordination Abnormal Health Quilonum Retard PS Glaxosmithkline ORAL Movement Disorder Professional Restlessness Therapeutic Agent Toxicity Tremor Date:04/03/03ISR Number: 4084102-8Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040603A Age:44 YR Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Asthenia Initial or Prolonged Back Pain 150MG per day 142 DAY Diarrhoea 400MG per day 39 DAY Drug Toxicity Nausea Pyrexia Vomiting 7.5MG Per day 39 DAY Report Source Product Role Manufacturer Route Health Professional Quilonum Retard Clozapine PS C Glaxosmithkline ORAL ORAL Nefadar C ORAL Zolpidem Blopress Nebilet Zopiclon C C C C ORAL ORAL ORAL ORAL Date:04/04/03ISR Number: 4085044-4Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040372A Age:52 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 36000MG Initial or Prolonged Single dose PT Ankle Fracture Bradycardia Circulatory Collapse Fall Hyporeflexia Hypotension Somnolence Suicide Attempt 22-Aug-2005 Page: 522 10:48 AM Report Source Product Role Manufacturer Route Quilonum PS Glaxosmithkline ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/03ISR Number: 4085128-0Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0350706A Age:41 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 6 YR Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Hallucination, Visual Eskalith PS Glaxosmithkline ORAL Medication Error Nocturia Psychotic Disorder Schizophrenia Somnolence Risperdal C Date:04/04/03ISR Number: 4085215-7Report Type:Expedited (15-DaCompany Report #AT-ROCHE-335077 Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 2 DAY 4 DAY 13 DAY 13 DAY 3 DAY 7 PT Report Source Product Role Manufacturer Route Cardiac Arrest Rivotril PS Roche ORAL Cardiac Failure Acute Rivotril SS Roche ORAL Mania Zyprexa SS ORAL Quilonorm Retard SS ORAL Augmentin SS ORAL Augmentin Augmentin SS SS ORAL ORAL Depakine Depakine Depakine SS SS SS ORAL ORAL ORAL Depakine SS ORAL Nubain SS DAY 26 DAY 2 DAY SUBCUTANEOUS MG/2ML. GIVEN IN THE EVENING. STRENGTH 20 SUBCUTANEOUS Scopolamine SS Pantoloc Akineton C C Roche GIVEN IN THE EVENING. 2 ORAL ORAL DAY Date:04/04/03ISR Number: 4090055-9Report Type:Expedited (15-DaCompany Report #200300783S Age:46 YR Gender:Female I/FU:F Outcome Dose Death 10MG, PO 4 MG 80MG, 4MG 100MG 20MG 25MG PT Report Source Product Role Sudden Death Foreign Health ...Yslee Zolpidem Tablet 10mg PS Professional Dogmatyl Sulpiride Tablet 100mg SS ...Imas Lithium Carbonate Tablet 200mg SS Artane Trihexyphonidyl Hydrochloride Tablet 2mg SS Toledomin Milnacipran Hydrochloride Tablet SS Tetramide Mianserin Hydrochloride Tablet SS Contmin Chlorpromazine Tablet 25mg SS 18 94 2 21 7 88 21 MON MON YR MON MON MON MON Silece Flunitrazepam Tablet 22-Aug-2005 Page: 523 Manufacturer Route Duration 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 2MG 150MG 61 11 2mg SS Seroquel Quetiapine Fumarate Tablet SS MON MON Date:04/04/03ISR Number: 4090195-4Report Type:Expedited (15-DaCompany Report #2003GB00695 Age:66 YR Gender: I/FU:I Outcome Dose Duration Required Intervention to 800 MG DAILY Prevent Permanent 2.5 MG DAILY Impairment/Damage PT Report Source Product Role Drug Interaction Drug Level Increased Foreign Health Atenolol Lithium PS SS Professional Bendrofluazide SS Other Venlafaxine Sulpiride Detrusitol C C C Manufacturer Route Manufacturer Route Date:04/04/03ISR Number: 4090617-9Report Type:Expedited (15-DaCompany Report #B0294723A Age: Gender:Male I/FU:F Outcome PT Dose Duration Required Blood Thyroid Stimulating Intervention to Hormone Increased Prevent Permanent Congenital Hypothyroidism Impairment/Damage Drug Exposure During TRANSPLACENTAL TRANSPLACENTA Pregnancy RY Goitre Congenital Pregnancy Report Source Product Role Foreign Literature Health Professional Eskalith (Formulation Unknown) (Lithium Carbonate) PS Cyamemazine Venlafaxine Hydrochloride Olanzapine C C C Date:04/07/03ISR Number: 4085581-2Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12227005 Age:50 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Life-Threatening Hospitalization Initial or Prolonged Other Haemodynamic Instability Intentional Misuse Lactic Acidosis Nausea Renal Failure Acute Suicide Attempt Tachypnoea Vomiting Date:04/07/03ISR Number: 4088123-0Report Type:Direct Age:59 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 1200MG QHS Initial or Prolonged ORAL PT Attention Disorder Coordination Abnormal Delirium Leukocytosis Sluggishness Therapeutic Agent Toxicity Tremor 10:48 AM Lithium Tricyclic Antidepressants PS Bristol-Myers Squibb Company ORAL Manufacturer Route SS SS Company Report #CTU 190326 Report Source Product Role Lithium Carbonate PS ORAL Hctz 25mg SS ORAL Deficit/Hyperactivity 25MG QD ORAL 22-Aug-2005 Page: 524 Glucophage Tabs 850 Mg FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/03ISR Number: 4086291-8Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0296292A Age:42 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Abdominal Pain UNKNOWN 800MG Per day Initial or Prolonged Blood Creatinine 300MG Twice Increased per day 296 DAY Blood Sodium Increased 150MG Twice Blood Urea Increased per day Coordination Abnormal Dehydration Diabetes Insipidus Grand Mal Convulsion Report Source Product Role Manufacturer Lithium Carbonate PS Glaxosmithkline Clozapine SS Ranitidine C Sodium Phosphate C Route ORAL Glaxosmithkline ORAL Manufacturer Route Date:04/08/03ISR Number: 4091123-8Report Type:Expedited (15-DaCompany Report #2003013100 Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 40 MG (BID), Initial or Prolonged ORAL Other 1500 MG PT Report Source Product Role Blood Cholesterol Health Geodon (Ziprasidone) PS ORAL Increased Professional Lithane (Lithium) SS ORAL Valproate Semisodium (Valproate Semisodium) C Diabetes Mellitus Nocturia (DAILY), ORAL Date:04/08/03ISR Number: 4091440-1Report Type:Expedited (15-DaCompany Report #2003-BP-02012RO (0) Age:36 YR Gender:Female I/FU:I Outcome Dose Death PT Report Source Product Psychotic Disorder Other Lithium Carbonate Duration Role Manufacturer Route Capsules Usp, 300 Mg (Lithium Carbonate) PS ORAL PO YEARS Date:04/08/03ISR Number: 4091879-4Report Type:Expedited (15-DaCompany Report #03P-009-0214904-00 Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Bradycardia Cardiac Arrest Drug Level Above Therapeutic Inflammation Foreign Health Professional Depakine (Depakene)(Sodium Valproate/Valproic Acid) (Sodium Valproate/Valproic PS ORAL Olanzapine SS ORAL Lithium Carbonate SS ORAL Nalbuphine Hydrochloride SS Hyoscine SS Clonazepam SS .... Amoxicillin Trihydrate Pantoprazole C SEE IMAGE Oxygen Saturation 30 MG, 1 IN 1 Decreased D, PER ORAL Pyrexia PER ORAL Self-Medication Shock 20 MG, 1 IN 1 Toxicologic Test Abnormal SUBCUTANEOUS D, SUBCUTANEOUS SUBCUTANEOUS 0.5 ML, 1 IN 1 D, SUBCUTANEOUS 16 MG, 1 IN 1 D, PER ORAL 22-Aug-2005 Page: 525 10:48 AM C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Biperiden C Date:04/09/03ISR Number: 4087784-XReport Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040772A Age:22 YR Gender:Male I/FU:I Outcome Dose Duration Other 900MG per day HR 50MG per day HR 320MG per day HR 60MG per day HR 6MG per day HR PT Report Source Product Role Manufacturer Route Intentional Misuse Quilonum Retard PS Glaxosmithkline ORAL Suicide Attempt Atarax SS ORAL Dipiperon SS ORAL Fluoxetin SS ORAL Risperdal SS ORAL Date:04/09/03ISR Number: 4087785-1Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040777A Age:61 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 450MG Twice Initial or Prolonged per day PT Report Source Blood Creatinine Product Role Manufacturer Route Quilonorm Retard PS Glaxosmithkline ORAL Product Role Manufacturer Route Eskalith Cr 450 Mg Bid PS Blood Potassium Blood Sodium Depression Dizziness Tremor White Blood Cell Count Date:04/09/03ISR Number: 4090309-6Report Type:Direct Age:18 YR Gender:Male I/FU:I Outcome Dose Other PT Company Report #CTU 190558 Report Source Duration 450 MG PO BID Micturition Disorder Micturition Urgency ORAL Pollakiuria Specific Gravity Urine Urine Osmolarity Date:04/09/03ISR Number: 4092783-8Report Type:Expedited (15-DaCompany Report #PHBS2003JP01119 Age:72 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Fall Forearm Fracture Foreign Literature Health Professional Melleril (Thioridazine Hydrochloride) Tablet PS Levomepromazine Hydrochloride (Levomeprazine Hydrochloride) SS Lithium Carbonate (Lithium Carbonate) SS Prothiaden (Dosulepin) SS Zopiclone (Zopiclone) SS Tiapride Hydrochloride (Tiapride Hydrochloride) SS 30 MG/DAY, Other ORAL 5 MG/D 600 MG/D 75 MG/D 30 MG/D 25 MG/D 22-Aug-2005 Page: 526 10:48 AM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Biperiden Hydrochloride (Biperiden Hydrochloride) SS 3 MG/D Date:04/09/03ISR Number: 4093279-XReport Type:Expedited (15-DaCompany Report #LBID00203000872 Age:21 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1050 MG DAILY PO 2 PT Report Source Product Role Agitation Back Pain Literature Health Lithobid (Lithium Carbonate) PS Blindness Hysterical Professional YR Blood Urea Decreased Central Pontine Myelinolysis Coordination Abnormal Crying Diarrhoea Disturbance In Attention Drug Level Above Therapeutic Eye Movement Disorder Facial Paresis Fatigue Gait Disturbance Hallucination, Visual Headache Hypoaesthesia Intracranial Pressure Increased Mood Swings Mydriasis Nausea Papilloedema Photosensitivity Reaction Pollakiuria Screaming Thirst Visual Disturbance Vomiting White Blood Cell Count Manufacturer Route ORAL Increased Date:04/10/03ISR Number: 4088151-5Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0296700A Age:64 YR Gender:Male I/FU:F Outcome Dose Disability 13 YR PT Report Source Product Role Manufacturer Route Renal Interstitial Quilonorm PS Glaxosmithkline ORAL Fibrosis Leponex SS Duration YR Tubulointerstitial Nephritis Date:04/10/03ISR Number: 4088387-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12227005 Age:50 YR Gender:Female I/FU:F Outcome Life-Threatening Hospitalization 22-Aug-2005 Page: 527 10:48 AM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Other PT Dose Report Source Product Role Manufacturer Route Glucophage Tabs 850 Mg PS Bristol-Myers Squibb Company ORAL Duration Cardiac Failure Drug Toxicity Haemodynamic Instability Intentional Misuse Lactic Acidosis Lung Disorder Renal Failure Acute Suicide Attempt Date:04/10/03ISR Number: 4088640-3Report Type:Direct Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900MG QHS Required ORAL Intervention to Prevent Permanent Impairment/Damage PT Neurological Examination Abnormal Lithium Tricyclic Antidepressants SS C Company Report #CTU 190592 Report Source Product Role Manufacturer Route Lithium Carbonate Sa 450 Mg Eskalith PS Eskalith ORAL Levothryroxine Synthroid Pindolol Calcium Carbonate Hydroxyzine Vit E Nortriptyline Risperidone Estrogen Cyproheptadine Diazepam Alprazolam Sulfamethoxazole Trimeth Lithium Carb Eskalith Candesartan C C C C C C C C C C C C C C C C Renal Impairment Therapeutic Agent Toxicity Date:04/10/03ISR Number: 4091385-7Report Type:Direct Age: Gender:Male I/FU:I Company Report #CTU 190632 Outcome Dose Duration Hospitalization 300MG PO BID Initial or Prolonged PT Report Source Product Role Clonic Convulsion Lithium PS Coma Lethargy Tremor Theophylline Risperdal Trazodone C C C Date:04/10/03ISR Number: 4093563-XReport Type:Expedited (15-DaCompany Report #B0295537A Age:60 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 528 10:48 AM PT Cerebral Atrophy Cerebral Ventricle Dilatation Delirium Depressed Level Of Consciousness Disorientation Drug Interaction Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysarthria Electroencephalogram Abnormal Dose Report Source Product Role Foreign Literature Health Professional Lithium Carbonate (Formulation Unknown) (Lithium Carbonate) Haloperidol PS C Manufacturer Route Manufacturer Route Duration Extrapyramidal Disorder Hallucination, Visual Psychomotor Hyperactivity Speech Disorder Therapeutic Agent Toxicity Date:04/10/03ISR Number: 4093587-2Report Type:Expedited (15-DaCompany Report #2003-DE-00019YA(1) Age:65 YR Gender:Male I/FU:F Outcome Dose Disability 0.4 MG PT Report Source Product Role Blood Fibrinogen Calcinosis Cholelithiasis Foreign Other Omix (Tamsulosin) (Nr) (Tamsulosin Hydrochloride) PS ORAL Hyperparathyroidism Nephrolithiasis Depamide (Valproate) (Nr) SS ORAL Renal Cyst Renal Failure Teralithe (Lithium Carbonate) (Nr) SS ORAL Therapeutic Agent Toxicity Tadenan (Pygeum Africanum) (Nr) SS ORAL Duration 365 DAY PO 1500 MG, PO 100 MG, PO Date:04/11/03ISR Number: 4088884-0Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040830A Age:81 YR Gender:Female I/FU:I Outcome Dose Other 9000MG per day PT Report Source Product Role Manufacturer Route Suicide Attempt Health Quilonum Retard PS Glaxosmithkline ORAL Vomiting Professional Duration Date:04/11/03ISR Number: 4091133-0Report Type:Direct Age:64 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200MG QHS Required ORAL Intervention to Prevent Permanent Impairment/Damage PT Company Report #CTU 190717 Report Source Therapeutic Agent Toxicity Product Role Lithium Carbonate 300mg PS Manufacturer Route ORAL Date:04/14/03ISR Number: 4095238-XReport Type:Expedited (15-DaCompany Report #2003014034 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization (BID),ORAL Initial or Prolonged Other 45 MG, ORAL PT Report Source Product Role Back Injury Consumer Lithane (Lithium) PS ORAL Back Pain Dysgraphia Nardil (Phenelzine Sulfate) SS ORAL Eating Disorder Fall Intentional Misuse Migraine Paracetamol (Paracetamol) All Other Therapeutic Products 10:48 AM Route Suicide Attempt Tremor Weight Fluctuation All Other Therapeutic Products SS SS ORAL 22-Aug-2005 Page: 529 Manufacturer C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/03ISR Number: 4095501-2Report Type:Expedited (15-DaCompany Report #PHNR2003AU00641 Age:41 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged 250, 300 MG/ PT Report Source Product Role Blood Alkaline Phosphatase Increased C-Reactive Protein Foreign Other Clozaril (Clozapine)(Clozapin e) Tablet PS Haematocrit Decreased Lithium (Lithium) SS Neutrophil Count Increased Platelet Count Increased Red Blood Cell Count Decreased Renal Failure Therapeutic Agent Toxicity White Blood Cell Count Increased Ranitidin "Aliud Pharma" Valproate Sodium Alanzapine Diazepam Ceclor C C C C C Manufacturer Route ORAL Increased ONCE/DAY, Dialysis ORAL 625 MG, BID Date:04/15/03ISR Number: 4095597-8Report Type:Expedited (15-DaCompany Report #2003AP01246 Age:46 YR Gender:Female I/FU:F Outcome Dose Duration Death 50 MG TID PO PT Report Source Product Role Manufacturer Route Cardiovascular Disorder Foreign Seroquel PS ORAL Sudden Death Health Limas SS ORAL Professional Artane SS ORAL Other Dogmatyl SS ORAL Toledomin SS ORAL Tetramide SS ORAL Contomin SS ORAL 200 MG QID PO 2 MG BID PO 100 MG BID PO 50 MG PO 20 MG QD PO 25 MG QD PO Silece SS ORAL Zolpidem SS ORAL 2 MG QD PO 10 MG QD PO Date:04/16/03ISR Number: 4094682-4Report Type:Direct Age:45 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Asthenia Confusional State Haemodialysis Somnolence Date:04/16/03ISR Number: 4096124-1Report Type:Direct Age:38 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 900MG QAM, Company Report #CTU 191046 PT Drug Interaction Laboratory Test Abnormal Product Role Lithium PS Manufacturer Route Manufacturer Route Company Report #CTU 191113 Report Source Product Role Lithium Carbonate 300mg Cap PS ORAL Lisinopril 40mg Tab SS ORAL Topiramate Quetiapine Fumarate Diltiazem Lorazepam Tab Lorazepam (Ativan) C C C C Renal Failure Acute 1200MG QHS BY MOUTH 40MG QDBY MOUTH (PO) 22-Aug-2005 Page: 530 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inj C Date:04/17/03ISR Number: 4098291-2Report Type:Expedited (15-DaCompany Report #EMADSS2003002526 Age:76 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE, PT Report Source Product Role Manufacturer Route Bronchopneumonia Depression Foreign Study Galantamine (Tablet) (Galantamine) PS ORAL Dysphagia Health Fatigue Gait Disturbance Professional Other Lithionit (Lithium Sulfate) SS ORAL ORAL 41.5 MG, 2 IN Muscle Spasms 1 DAY (S), Salivary Hypersecretion ORAL Tremor Enalapril Maleate (Enalapril Maleate) Mirtazapine (Mirtazapine) Risperidone (Unspecified) (Risperidone) Oxazepam (Oxazepam) Calcium Carbonate (Calcium Carbonate) Lactulose (Lactulose) Paracetamol (Paracetamol) Zopiclone (Zopiclone) Paracetamol With Codeine (Acetaminophen/Codei ne) C C C C C C C C C Date:04/21/03ISR Number: 4093933-XReport Type:Expedited (15-DaCompany Report #AU-GLAXOSMITHKLINE-B0297551A Age: Gender:Male I/FU:F Outcome Dose Other YR PT Report Source Product Role Manufacturer Lithium Carbonate PS Glaxosmithkline Route Duration Renal Failure Chronic Date:04/21/03ISR Number: 4093955-9Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0350706A Age:41 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 7 YR Initial or Prolonged Other UNKNOWN PT Report Source Product Role Manufacturer Route Dysgeusia Consumer Eskalith PS Glaxosmithkline ORAL Hallucination, Visual Libido Decreased Risperdal Navane C C Mania Cogentin C UNKNOWN Medication Error Pollakiuria Psychotic Disorder Schizophrenia Somnolence Therapeutic Agent Toxicity Vomiting 22-Aug-2005 Page: 531 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/03ISR Number: 4094104-3Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12227005 Age:53 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Blood Pressure Cardiac Failure Cardiogenic Shock Dehydration Depressed Level Of Consciousness Drug Toxicity Electrolyte Imbalance Gastroenteritis Haemodialysis Hypoglycaemia Intentional Misuse Lactic Acidosis Pneumonia Haemophilus Renal Failure Acute Suicide Attempt Tachypnoea Health Professional Glucophage Tabs 850 Mg PS Bristol-Myers Squibb Company ORAL Laroxyl Teralithe Cotareg Motilium SS SS SS C Date:04/21/03ISR Number: 4098436-4Report Type:Expedited (15-DaCompany Report #C2003-0743.01 Age:30 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG QD, Other ORAL ; PT Report Source Product Role Manufacturer Route Insomnia Restlessness Health Professional Clozapine Tablets 100 Mg Mylan PS Mylan ORAL Lithium SS Speech Disorder Weight Decreased SEVERAL MONTHS SEVERAL MONTHS Date:04/21/03ISR Number: 4099271-3Report Type:Expedited (15-DaCompany Report #03P-009-0214904-00 Age:42 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Cardiac Arrest Drug Level Increased Inflammation Mania Oxygen Saturation Foreign Health Professional Depakine (Depakene) (Sodium Valproate/Valproic Acid) (Sodium Depakine (Depakene) PS Olanzapine SS ORAL Self-Medication Lithium Carbonate SS ORAL Shock Clonazepam SS ORAL Nalbuphine Hydrochloride SS Hyoscine SS SEE IMAGE Decreased 30 MG, 1 IN 1 Pneumonia D, PER ORAL PER ORAL 16 MG, 1 IN 1 D, PER ORAL SUBCUTANEOUS 20 MG, 1 IN 1 D, SUBCUTANEOUS SUBCUTANEOUS 0.5 ML, 1 IN 1 D, SUBCUTANEOUS 22-Aug-2005 Page: 532 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/03ISR Number: 4099562-6Report Type:Expedited (15-DaCompany Report #2003-DE-00014GD Age:20 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG > 3 PT Report Source Product Role Akathisia Anxiety Literature Lithium Carbonate (Lithium Carbonate) PS Body Temperature Increased Risperidone (Risperidone) SS Catatonia Cognitive Disorder Paroxetine (Paroxetine) SS Constipation Drug Interaction Olanzapine (Antipsychotics) SS Drug Level Below Therapeutic Drug Level Increased Benztropine (Benzatropine Mesilate) SS Dry Mouth Insomnia Nortriptyline (Nortriptyline) SS Manufacturer Route Manufacturer Route Bipolar Disorder MONTHS 3 MG 20 MG 5 MG 2 MG 50 MG Parkinsonism Tremor Vision Blurred Date:04/22/03ISR Number: 4097297-7Report Type:Direct Age:49 YR Gender:Male I/FU:I Outcome Dose Other PT Company Report #CTU 191401 Report Source Product Role Lithium PS Duration Confusional State Delirium Date:04/23/03ISR Number: 4101134-1Report Type:Expedited (15-DaCompany Report #LBID00203000872 Age:21 YR Gender:Female I/FU:F Outcome Hospitalization - PT Agitation Initial or Prolonged 22-Aug-2005 Page: 533 10:48 AM Back Pain Blindness Hysterical Blood Urea Decreased Central Pontine Myelinolysis Confusional State Conversion Disorder Coordination Abnormal Crying Delirium Demyelination Diarrhoea Disturbance In Attention Fatigue Gait Disturbance Hallucination, Visual Headache Hypoaesthesia Intracranial Pressure Increased Mood Swings Mydriasis Nausea Papilloedema Photosensitivity Reaction Pollakiuria FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Screaming Thirst Visual Disturbance Report Source Product Role Vomiting White Blood Cell Count Literature Health Lithobid (Lithium Carbonate) PS Increased Professional Manufacturer Route Duration ORAL 1050 MG DAILY, PO 2 YR Date:04/23/03ISR Number: 4101711-8Report Type:Expedited (15-DaCompany Report #2003016166 Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 210 MG (BID) Initial or Prolonged 800 MG (BID) Other PT Report Source Product Role Blood Creatinine Foreign Lithane (Lithium) PS Increased Literature Celecoxib SS Bradycardia Drug Level Above Therapeutic Haemodialysis Hypotension Malaise Sinoatrial Block Somnolence Health Professional Sertraline (Sertraline) Levomepromazine (Levomepromazine) Esomeprazole (Esomeprazole) Tibolone (Tibolone) Ibuprofen (Ibuprofen) Manufacturer Route Manufacturer Route C C C C C Date:04/23/03ISR Number: 4102211-1Report Type:Expedited (15-DaCompany Report #2003-BP-02209RO Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Akathisia Aphasia Blood Pressure Increased Health Professional Other Lithium Carbonate Capsules Usp, 300 Mg (Lithium Carbonate) PS ORAL Clozapine (Clozapine) SS ORAL PO Drug Interaction Insomnia 300 MG QD Restlessness (100 MG), PO; Weight Decreased SEVERAL MONTHS Date:04/23/03ISR Number: 4112456-2Report Type:Periodic Age:22 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Disability Required 450 MG / Intervention to TWICE PER DAY Prevent Permanent / ORAL Impairment/Damage Company Report #A0380041A PT Report Source Product Role Alanine Aminotransferase Aspartate Aminotransferase Csf White Blood Cell Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS ORAL Risperidone (Risperidone) SS ORAL Neuroleptic Malignant Syndrome NIGHT / ORAL Date:04/23/03ISR Number: 4112457-4Report Type:Periodic Age:73 YR Gender:Female I/FU:I 22-Aug-2005 Page: 534 10:48 AM Route Count Increased 3 MG / AT Outcome Hospitalization Initial or Prolonged Other Manufacturer PT Dehydration Pyrexia Therapeutic Agent Company Report #A0373625A FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Toxicity Tremor Dose Report Source Product Role Health Professional Eskalith Tablet-Controlled Release (Lithium Carbonate) PS Ceftriaxone Sodium Lorazepam Insulin C C C Manufacturer Route Duration ORAL 450 MG / PER DAY / ORAL Date:04/23/03ISR Number: 4112458-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report #A0368269A PT Report Source Product Role Bladder Disorder Drug Interaction Somnolence Therapeutic Agent Consumer Esaklith Tablet-Controlled Tablet (Lithium Carbonate) PS Metformin Hydrochloride (Metformin Hydrochloride) Liotrix Clonazepam SS C C Manufacturer Route ORAL ORAL Toxicity Urine Abnormality Urine Odour Abnormal Vision Blurred Date:04/23/03ISR Number: 4112459-8Report Type:Periodic Age:29 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report #A0372683A PT Report Source Product Epilepsy Therapeutic Agent Toxicity Health Professional Lithium Carbonate (Lithium Carbonate) (Generic) Clozapine Tablet PER DAY / Role PS SS Manufacturer Route ORAL ORAL Date:04/24/03ISR Number: 4096612-8Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0297755A Age: Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization UNKNOWN Initial or Prolonged Other PT Abnormal Behaviour Psychotic Disorder Report Source Product Role Manufacturer Route Paxil Lithium PS SS Glaxosmithkline Glaxosmithkline ORAL Suicide Attempt Therapeutic Agent Toxicity Date:04/24/03ISR Number: 4096648-7Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0405145A Age:52 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 535 10:48 AM PT Blood Glucose Increased Chest Pain Chills Coordination Abnormal Coronary Artery Occlusion FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Level Above Therapeutic Dyspnoea Dose UNKNOWN dosage text UNKNOWN UNKNOWN Report Source Product Role Manufacturer Consumer Eskalith PS Glaxosmithkline Vasotec SS Verapamil SS Zocor C Malaise Metformin C Muscular Weakness Glyburide C Zestril C Route Duration Eye Pain 1350MG See General Physical Health 13 YR Deterioration 5MG Per day 3 MON Headache 180MG Per day Lethargy UNKNOWN UNKNOWN UNKNOWN UNKNOWN Myalgia 5MG Per day 1 MON Nausea Palpitations Tremor Vomiting Date:04/25/03ISR Number: 4097997-9Report Type:Direct Age: Gender: I/FU:I Outcome Dose Duration Other Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Laboratory Test Abnormal Medication Error Date:04/25/03ISR Number: 4101213-9Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Death Hospitalization - Company Report #USP 51454 PT Medication Error Product Role Manufacturer Maxzide(Hydrochlorot hiazide, Triamterene) Lithium Carbonate PS SS Bertek Product Role Manufacturer Lithium Carbonate Lithium Carbonate PS SS Roxanne Roxanne Route Company Report #USP 55806 Report Source Route Initial or Prolonged Date:04/25/03ISR Number: 4103036-3Report Type:Expedited (15-DaCompany Report #2003-BP-02317RO Age: Gender:Female I/FU:I Outcome Dose Duration Death Hospitalization Initial or Prolonged PRESCRIBED PT Report Source Product Role Medication Error Overdose Health Professional Other Lithium Carbonate Capsules Usp, 150 Mg (Lithium Carbonate) PS Manufacturer Route ORAL 150MG; DISPENSED 300MG (150 MG), PO Date:04/25/03ISR Number: 4103171-XReport Type:Expedited (15-DaCompany Report #2003016563 Age:55 YR Gender: I/FU:I Outcome Dose Death ORAL PT Report Source Product Role Manufacturer Route Completed Suicide Consumer Lithane (Lithium) PS ORAL Health Professional Quetiapine (Quetiapine) SS ORAL Fluphenazine (Fluphenazine) SS ORAL Duration ORAL ORAL 22-Aug-2005 Page: 536 10:48 AM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/03ISR Number: 4103172-1Report Type:Expedited (15-DaCompany Report #2003016464 Age:44 YR Gender: I/FU:I Outcome Dose Death ORAL PT Report Source Product Role Manufacturer Route Cardiac Arrest Literature Lithane (Lithium) PS ORAL Completed Suicide Health Ethanol (Ethanol) SS ORAL Respiratory Arrest Professional Trazodone (Trazodone) SS ORAL All Other Therapeutic Products SS ORAL Duration ORAL ORAL ORAL Date:04/25/03ISR Number: 4103177-0Report Type:Expedited (15-DaCompany Report #2003016549 Age:80 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Drug Toxicity Literature Health Professional Lithane (Lithium) Temazepam (Temazepam) PS Manufacturer Route Manufacturer Route Duration SS Date:04/25/03ISR Number: 4103212-XReport Type:Expedited (15-DaCompany Report #2003016566 Age:26 YR Gender: I/FU:I Outcome Dose Death ORAL PT Report Source Product Role Unevaluable Event Literature Lithane (Lithium) PS ORAL Health Professional Olanzapine (Olanzapine) SS ORAL Duration ORAL Date:04/28/03ISR Number: 4098572-2Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0405516A Age: Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Other 1 DAY Overdose Eskalith PS Glaxosmithkline ORAL Manufacturer Route Date:04/28/03ISR Number: 4103380-XReport Type:Expedited (15-DaCompany Report #LBID00203001025 Age: Gender: I/FU:I Outcome Dose Disability PT Report Source Product Role Myoclonus Literature Health Lithium Carbonate (Lithium Carbonate) PS Duration ORAL 300 MG BID PO Professional Date:04/28/03ISR Number: 4103408-7Report Type:Expedited (15-DaCompany Report #2003016466 Age:39 YR Gender: I/FU:I Outcome Dose Death ORAL PT Report Source Product Role Manufacturer Route Drug Toxicity Literature Lithane (Lithium) PS ORAL Medication Error Health Professional Paracetamol (Paracetamol) SS ORAL Duration ORAL Date:04/28/03ISR Number: 4103696-7Report Type:Expedited (15-DaCompany Report #2003016544 Age:45 YR Gender:Unknown I/FU:I Outcome Dose Death 22-Aug-2005 Page: 537 PT Report Source Product Role Drug Level Increased Medication Error Literature Health Professional Lithane (Lithium) PS Duration 10:48 AM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/03ISR Number: 4104080-2Report Type:Expedited (15-DaCompany Report #2003016467 Age:44 YR Gender:Unknown I/FU:I Outcome Dose Death ORAL PT Report Source Product Role Manufacturer Route Death Literature Lithane (Lithium) PS ORAL Drug Toxicity Health Professional Paracetamol (Paracetamol) SS ORAL Venlafaxine (Venlafaxine) SS ORAL Duration ORAL ORAL Date:04/28/03ISR Number: 4104087-5Report Type:Expedited (15-DaCompany Report #2003157053NO Age:58 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 400 MG, BID, ORAL 5 PT Report Source Product Role Manufacturer Route Abdominal Pain Arrhythmia Foreign Literature Celebrex (Celecoxib) Capsule PS ORAL Blood Creatinine Health Increased Professional Lithium (Lithium) SS ORAL Bradycardia Other Sertraline (Sertraline) Levomepromazine Esomeprazole Tibolone (Tibolone) Ibuprofen C C C C C DAY 84 MG/MORNING, Drug Interaction 126MG/NIGHT, Drug Level Above ORAL Therapeutic Haemodialysis Hypotension Malaise Nausea Sedation Sinoatrial Block Somnolence Date:04/28/03ISR Number: 4104101-7Report Type:Expedited (15-DaCompany Report #2003016548 Age:34 YR Gender:Unknown I/FU:I Outcome Dose Death Other PT Report Source Product Role Cardio-Respiratory Arrest Completed Suicide Literature Health Professional Lithane (Lithium) Opioids Benzodiazepine Derivatives PS SS Manufacturer Route Manufacturer Route Manufacturer Route Duration SS Date:04/28/03ISR Number: 4104109-1Report Type:Expedited (15-DaCompany Report #2003016546 Age:41 YR Gender:Unknown I/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Literature Health Professional Lithane (Lithium) Haloperidol (Haloperidol) PS Duration SS Date:04/28/03ISR Number: 4104122-4Report Type:Expedited (15-DaCompany Report #2003016545 Age:50 YR Gender:Unknown I/FU:I Outcome Dose Death 22-Au
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