Ritalin - Medical Marijuana ProCon.org

Ritalin - Medical Marijuana ProCon.org

FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/05/97ISR Number: 3011271-0Report Type:Periodic
Age:57 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
7 MG DAILY
Company Report #8-97223-003J
PT
Report Source
Product
Role
Drug Effect Increased
Consumer
Ativan
PS
Ritalin
SS
Norvasc
Ventolin
Xanax
Zocor
C
C
C
C
Manufacturer
Route
Duration
ORAL
Drug Interaction
ORAL TAB
15 MG DAILY
Date:11/17/97ISR Number: 3005889-9Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Disability
10MIG SINCE
Other
1991
PT
Company Report #
Report Source
Product
Role
Ritalin
PS
Manufacturer
Route
Manufacturer
Route
Duration
Aggression
Agitation
Amnesia
Confusional State
Decreased Appetite
Developmental Delay
Disinhibition
Disturbance In Attention
Failure To Thrive
Narcolepsy
Personality Change
Date:11/19/97ISR Number: 3001611-0Report Type:Expedited (15-DaCompany Report #MPI-97418
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Hospitalization 55 MG
Initial or Prolonged
0.1 MG
Aggression
Health
Methylphenidate
PS
ORAL
Agitation
Professional
Clonidine Hcl
SS
ORAL
Bupropion
SS
ORAL
Convulsion
150 MG
Disorientation
Date:11/19/97ISR Number: 3001886-8Report Type:Expedited (15-DaCompany Report #MPI-97418
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization 55MG PO
Initial or Prolonged
0.1MG PO
PT
Report Source
Product
Role
Manufacturer
Route
Aggression
Health
Methylphenidate
PS
ORAL
Agitation
Professional
Clonidine Hcl
SS
ORAL
Bupropion
SS
ORAL
150MG PO
Date:12/11/97ISR Number: 3006497-6Report Type:Expedited (15-DaCompany Report #MCD 09/11/97
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
.1 MG
55 MG
18-Aug-2005
Page: 1
11:49 AM
PT
Report Source
Product
Role
Manufacturer
Route
Aggression
Agitation
Health
Professional
Clonidine
Hydrochloride
PS
ORAL
Methylphenidate
SS
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/11/97ISR Number: 3007720-4Report Type:Direct
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
25 MG PER DAY
PT
Company Report #
Report Source
Product
Role
Abnormal Behaviour
Methylphenidate
PS
Drug Withdrawal Syndrome
Inappropriate Affect
Lacrimation Increased
Lethargy
Salivary Hypersecretion
Stereotypy
Depakote
Tenex
C
C
Manufacturer
Route
Manufacturer
Route
Date:12/24/97ISR Number: 3012851-9Report Type:Expedited (15-DaCompany Report #97J-10394
Age:25 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
10MG, DAILY,
Hospitalization ORAL
Initial or Prolonged
PT
Report Source
Product
Role
Convulsion
Foreign
Ritalin
PS
Depressed Level Of
Health
Consciousness
Leukocytosis
Pyrexia
White Blood Cell Count
Increased
Professional
Melleril
Akineton
Eurodin
Nelbon
C
C
C
C
Date:01/02/98ISR Number: 3107767-3Report Type:Periodic
Age:40 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
75MG, PER
ORAL
Company Report #FLUV002970385
PT
Report Source
Product
Role
Manufacturer
Route
Chest Pain
Health
Luvox
PS
ORAL
Dyspnoea
Professional
Ritalin
SS
ORAL
Clarityn
C
Duration
ORAL
Hyperhidrosis
60MG, PER
ORAL
Synthroid
Zocor
Date:01/02/98ISR Number: 3112227-XReport Type:Periodic
Age:19 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization DAILY; ORAL
Initial or Prolonged
18-Aug-2005
Page: 2
11:49 AM
Company Report #97USA10862
PT
Report Source
Product
Role
Abnormal Behaviour
Health
Ritalin
PS
Belligerence
Dissociation
Hallucination
Medication Error
Psychotic Disorder
Speech Disorder
Professional
Date:01/02/98ISR Number: 3112228-1Report Type:Periodic
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization 12.5 MG, BID
Initial or Prolonged
C
C
Manufacturer
Route
ORAL
Company Report #97USA11284
PT
Report Source
Product
Role
Arthralgia
Health
Ritalin
PS
Autoimmune Disorder
Dermatitis
Rash Maculo-Papular
Urticaria
Professional
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/06/98ISR Number: 4517471-2Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #USP 080952
Report Source
Product
Role
Manufacturer
Ritalin
PS
Ciba(Brand)
Ritalin
SS
Ciba C Brand
Manufacturer
Route
Duration
Medication Error
TABLET
TAB
Date:01/08/98ISR Number: 3017194-5Report Type:Expedited (15-DaCompany Report #97D-10668
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
10 MG DAILY
PT
Report Source
Product
Role
Agranulocytosis
Foreign
Ritalin
PS
Bronchitis
Health
Ear Infection
Viral Infection
Professional
Route
Duration
ORAL
ORAL
Date:01/14/98ISR Number: 3015202-9Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Other
1 PO BID
PT
Tic
BID
Product
Role
Methylphenidate
PS
Manufacturer
Route
PT
ORAL
Company Report #
Report Source
Product
Role
Methylphenidate
PS
Manufacturer
Route
Duration
Drug Ineffective
20MG SR PO
Report Source
Duration
Date:01/28/98ISR Number: 3087036-0Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Company Report #
ORAL
Date:01/29/98ISR Number: 3089734-1Report Type:Periodic
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
ORAL
Company Report #8-97297-087K
PT
Report Source
Product
Role
Chest Pain
Consumer
Redux
PS
Ritalin
SS
2
Date:01/29/98ISR Number: 3112079-8Report Type:Periodic
Age:
Gender:Unknown
I/FU:F
Outcome
Dose
Duration
Hospitalization DAILY, ORAL
2
YR
Initial or Prolonged
RESPIRATORY
18-Aug-2005
Page: 3
ORAL
Company Report #8-97197-001L
PT
Report Source
Product
Role
Nervousness
Health
Redux
PS
Sedation
Professional
Company
Representative
Ritalin
SS
Manufacturer
Route
Duration
Date:01/29/98ISR Number: 3112226-8Report Type:Periodic
Age:15 YR
Gender:Male
I/FU:I
(INHALATION)
Route
YR
Palpitations
Outcome
Dose
Other
ORAL
Manufacturer
Duration
11:49 AM
Company Report #97USA10832
PT
Report Source
Product
Role
Convulsion
Consumer
Ritalin
PS
Marijuana
SS
INHALATION
ORAL
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/02/98ISR Number: 3021792-2Report Type:Expedited (15-DaCompany Report #9720178
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization 12.50 MG
Initial or Prolonged
TOTAL:
PT
Report Source
Product
Role
Manufacturer
Route
Aggression
Consumer
Zoloft
PS
ORAL
Drug Interaction
Health
Insomnia
Professional
Ritalin
SS
ORAL
DAILY:ORAL
30.00 MG
TOTAL:TID
:ORAL
Date:02/04/98ISR Number: 3023923-7Report Type:Expedited (15-DaCompany Report #98CDN10042
Age:
Gender:
I/FU:I
Outcome
Dose
Other
DAILY ORAL
PT
Report Source
Product
Role
Systemic Lupus
Foreign
Ritalin
PS
Erythematosus
Health
Professional
Other
Manufacturer
Route
Duration
ORAL
Date:02/05/98ISR Number: 3024031-1Report Type:Expedited (15-DaCompany Report #98USA10139
Age:45 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
50MG,DAILY,OR
PT
Report Source
Product
Role
Chest Pain
Health
Ritalin
PS
Myocardial Infarction
Professional
Wellbutrin
C
AL
Manufacturer
Route
ORAL
Date:02/05/98ISR Number: 3024423-0Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
1T TAB BID PO
PT
Company Report #
Report Source
Rash Generalised
Product
Role
Ritalin
PS
Manufacturer
Route
ORAL
10MG/1T TAB
QD PO 5MG
(GENERIC)
Date:02/09/98ISR Number: 3026190-3Report Type:Expedited (15-DaCompany Report #98J-10049
Age:64 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
DAILY
PT
Report Source
Product
Role
Dry Mouth
Foreign
Ritalin
PS
Eating Disorder
Oesophageal Stenosis
Thirst
Health
Professional
Halcion
Meilax
Rhythmy
Sediel
C
C
C
C
Date:02/12/98ISR Number: 3087877-XReport Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
4
YR
Route
PT
Dermatitis
11:49 AM
ORAL
Company Report #
Report Source
Product
Role
Ritalin
PS
Duration
Therapeutic Response
Decreased
18-Aug-2005
Page: 4
Manufacturer
Duration
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/20/98ISR Number: 3032689-6Report Type:Expedited (15-DaCompany Report #98USA10222
Age:29 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
20MG, TID,
PT
Report Source
Product
Role
Pulmonary Hypertension
Health
Ritalin
PS
Pondimin
SS
Manufacturer
Route
Manufacturer
Route
Duration
Professional
ORAL
5
MON
60MG, DAILY,
ORAL
7
MON
Date:02/20/98ISR Number: 3032697-5Report Type:Expedited (15-DaCompany Report #98F--10079
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
25 MG, DAILY,
PT
Report Source
Product
Role
Aggression
Foreign
Ritaline
PS
Homosexuality
Health
ORAL
ORAL
Professional
Other
Date:02/27/98ISR Number: 3037659-XReport Type:Expedited (15-DaCompany Report #98USA10270
Age:21 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
20 MG, TID,
PT
Report Source
Product
Role
Visual Acuity Reduced
Health
Ritalin
PS
Manufacturer
Route
Duration
ORAL
Professional
ORAL
Date:02/27/98ISR Number: 3043674-2Report Type:Direct
Age:25 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #
Report Source
Product
Role
Manufacturer
Route
Hospitalization 10MG/DAY
Initial or Prolonged
Disability
Epilepsy
Ritalin
Mental Impairment
Nervous System Disorder
Date:03/02/98ISR Number: 3132722-7Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
50.00 MG
PS
Company Report #9712159
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Zoloft
PS
ORAL
Dizziness
Ritalin
SS
ORAL
Drug Ineffective
Xanax
SS
ORAL
Solumedrol
SS
Duration
Accommodation Disorder
TOTAL: DAILY:
Constipation
ORAL
ORAL
ORAL
Dyspepsia
INTRAVENOUS
Libido Decreased
Nervousness
INTRAVENOUS
Date:03/02/98ISR Number: 3132826-9Report Type:Periodic
Age:52 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
200.00 MG
Company Report #9706889
PT
Report Source
Product
Role
Coordination Abnormal
Consumer
Zoloft
PS
ORAL
Paraesthesia
Health
Thinking Abnormal
Professional
Ritalin
SS
ORAL
Manufacturer
Route
Duration
TOTAL: DAILY:
ORAL
200.00 MG
TOTAL: DAILY:
ORAL
18-Aug-2005
Page: 5
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/02/98ISR Number: 3132962-7Report Type:Periodic
Age:59 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
150.00 MG
Company Report #9700569
PT
Report Source
Product
Role
Manufacturer
Route
Alopecia
Consumer
Zoloft
PS
ORAL
Hyperhidrosis
Ritalin
SS
ORAL
Tinnitus
Premarin
SS
ORAL
Zocor
Synthroid
Melatonin
C
C
C
Duration
Depersonalisation
TOTAL:BID:ORA
Dizziness
L
ORAL
ORAL
Date:03/02/98ISR Number: 3140842-6Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
25.00 MG
Company Report #9622246
PT
Report Source
Product
Role
Manufacturer
Agitation
Consumer
Zoloft
PS
ORAL
Mania
Health
Ritalin
SS
ORAL
Seldane
C
Route
Duration
TOTAL:DAILY:O
Professional
RAL
ORAL
Date:03/02/98ISR Number: 3144219-9Report Type:Periodic
Age:14 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
75.00 MG
Company Report #9702398
PT
Report Source
Product
Role
Dermatitis
Consumer
Zoloft
PS
Neurosis
Health
Manufacturer
Route
Duration
TOTAL:DAILY:O
ORAL
Oedema Peripheral
Professional
RAL
Pruritus
Ritalin
SS
Prednisone
C
ORAL
20.00 MG
Suicidal Ideation
TOTAL:DAILY:O
Urticaria
RAL
Date:03/02/98ISR Number: 3148580-0Report Type:Periodic
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
50.00 MG
Company Report #9617586
PT
Report Source
Product
Role
Manufacturer
Route
Dizziness
Consumer
Zoloft Tablets
PS
ORAL
Nausea
Health
Ritalin
SS
ORAL
Ambien
C
Duration
TOTAL DAILY
Professional
ORAL
ORAL
Date:03/02/98ISR Number: 3149433-4Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
100.00 MG
Company Report #9708479
PT
Report Source
Product
Role
Manufacturer
Route
Abnormal Dreams
Consumer
Zoloft
PS
ORAL
Klonopin
SS
ORAL
Ritalin
SS
ORAL
Tegretol
Zantac
C
C
Duration
Arthropathy
TOTAL: DAILY:
Condition Aggravated
ORAL
Emotional Disorder
4.50 MG
Nervousness
TOTAL: TID:
Rotator Cuff Syndrome
ORAL
ORAL
18-Aug-2005
Page: 6
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/06/98ISR Number: 3127759-8Report Type:Periodic
Age:28 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
37.5 MG DAILY
Company Report #8-97072-003B
PT
Report Source
Product
Role
Drug Interaction
Health
Effexor
PS
Drug Tolerance Increased
Professional
Dexedrine
Methamphetamine
Ritalin
SS
SS
SS
Manufacturer
Route
ORAL
ORAL
Headache
Skin Discolouration
40 MG
Date:03/06/98ISR Number: 3146617-6Report Type:Periodic
Age:
Gender:
I/FU:F
Outcome
Dose
Other
ORAL
Company Report #8-96358-003B
PT
Report Source
Product
Role
Manufacturer
Stupor
Health
Effexor
PS
ORAL
Professional
Ritalin
SS
ORAL
Ritalin Oral
C
Route
Duration
ORAL
Date:03/12/98ISR Number: 3140499-4Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 12 MG DAILY
Initial or Prolonged
ORAL
Company Report #JAUSA-27007
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Risperdal
PS
Janssen
ORAL
Ritalin
SS
Manufacturer
Route
Back Pain
Extrapyramidal Disorder
Date:03/16/98ISR Number: 3056072-2Report Type:Expedited (15-DaCompany Report #8-97199-009S
Age:39 YR
Gender:Female
I/FU:F
Outcome
Dose
PT
Duration
Report Source
Product
Role
Death
60 MG DAILY
Life-Threatening
ORAL
Hospitalization 20 MG THREE
Initial or Prolonged
TIMES DAILY
Ascites
Health
Coma
Professional
Oedema Peripheral
Other
Pondimin
PS
ORAL
Ritalin
SS
ORAL
Kcl
Klonopin
Lasix
Lithium
Methyltestosterone
Synthroid
Triazolam
Ritalin
C
C
C
C
C
C
C
C
Pneumonia
Pulmonary Hypertension
ORAL
Date:03/19/98ISR Number: 3057890-7Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Methylphenidate
Clonidine
PS
SS
Duration
Aggression
Date:03/20/98ISR Number: 3059845-5Report Type:Expedited (15-DaCompany Report #9805481
Age:15 YR
Gender:Male
I/FU:I
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 7
11:49 AM
PT
Coordination Abnormal
Diarrhoea
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Gait Disturbance
Headache
Otitis Media
Report Source
Product
Role
Pharyngolaryngeal Pain
Foreign
Zoloft
PS
ORAL
Photophobia
Health
Pyrexia
Professional
Methylphenidate
SS
ORAL
Manufacturer
Route
Duration
100.00 MG
TOTAL:DAILY:O
RAL
Company
50.00 MG
Representative
TOTAL:TID:ORA
L
Date:03/25/98ISR Number: 3062047-XReport Type:Expedited (15-DaCompany Report #9804260
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
50.00 MG
PT
Report Source
Product
Role
Manufacturer
Route
Acidosis
Literature
Zoloft
PS
ORAL
Blood Ph Decreased
Health
Decreased Appetite
Professional
Methylphenidate
SS
ORAL
Duration
TOTAL:DAILY:O
RAL; TAB
Grand Mal Convulsion
80.00 MG
TOTAL:ORAL
Date:03/31/98ISR Number: 3066461-8Report Type:Expedited (15-DaCompany Report #98USA10422
Age:7 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization 20 MG DAILY
Initial or Prolonged
ORAL
PT
Report Source
Product
Role
Dystonia
Consumer
Ritalin
PS
Oculogyration
Health
Tic
Professional
Manufacturer
Route
ORAL
Date:03/31/98ISR Number: 3066465-5Report Type:Expedited (15-DaCompany Report #98D--10222
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
15 MG ORAL
PT
Report Source
Product
Role
Thrombocythaemia
Foreign
Ritalin
PS
Manufacturer
Route
Duration
ORAL
Health
BID
Professional
Date:04/06/98ISR Number: 3062930-5Report Type:Expedited (15-DaCompany Report #98 USA 10475
Age:34 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 120 MG,
Initial or Prolonged
DAILY, ORAL
PT
Report Source
Product
Role
Attention
Health
Ritalin
PS
Deficit/Hyperactivity
Professional
Zoloft
C
Disorder
Condition Aggravated
Drug Ineffective
Date:04/09/98ISR Number: 3064067-8Report Type:Direct
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
PT
11:49 AM
Route
ORAL
Company Report #
Report Source
Product
Role
Manufacturer
Methylphenidate
PS
Schein
Duration
No Adverse Drug Effect
18-Aug-2005
Page: 8
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/10/98ISR Number: 3062912-3Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Methylphenidate
Clonidine
Nortriptyline
PS
SS
SS
Manufacturer
Route
Manufacturer
Route
Duration
Aggression
Drug Ineffective
Date:04/15/98ISR Number: 3065705-6Report Type:Expedited (15-DaCompany Report #98D-10222
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
15 MG, BID,
PT
Report Source
Product
Role
Thrombocythaemia
Foreign
Ritalin
PS
Duration
ORAL
Health
ORAL
40
DAY
Professional
Other
Date:04/27/98ISR Number: 3071064-5Report Type:Expedited (15-DaCompany Report #98USA10611
Age:
Gender:
I/FU:I
Outcome
PT
Dose
Duration
Congenital Anomaly
Arrhythmia
TRANSPLACENTAL
5 MG, ONCE,
Other
Complications Of Maternal
TRANSPLACENTA
Exposure To Therapeutic
L
Drugs
Report Source
Product
Role
Health
Ritalin
PS
Manufacturer
Route
Manufacturer
Route
Professional
Date:05/05/98ISR Number: 3073598-6Report Type:Expedited (15-DaCompany Report #98USA10632
Age:50 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 10 MG, BID
PT
Report Source
Product
Role
Blood Pressure Abnormal
Health
Ritalin
PS
ORAL
Initial or Prolonged
Bradycardia
Chest Pain
Dyspnoea Exertional
Eosinophil Count
Increased
Hypotension
Myocardial Infarction
Nausea
Pyrexia
White Blood Cell Count
Increased
Professional
Droperidol Solution
Heparin Solution
Colace
Serax
Phenylephrine
Aspirin
Nitroglycerine
Maalox
Milk Of Magnesia
Tylenol
C
C
C
C
C
C
C
C
C
C
Date:05/05/98ISR Number: 3073716-XReport Type:Expedited (15-DaCompany Report #8-97199-009S
Age:39 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Death
60 MG DAILY
Life-Threatening
ORAL
Hospitalization 20 MG THREE
Initial or Prolonged
TIMES DAILY
Other
ORAL
PT
Report Source
Product
Role
Ascites
Consumer
Pondimin
PS
ORAL
Ritalin
SS
ORAL
Phentermine
SS
ORAL
Kcl
Klonopin
Lasix
Lithium
Methyltestosterone
C
C
C
C
C
Dyspnoea Exertional
Oedema Peripheral
Pneumonia
Pulmonary Hypertension
11:49 AM
Route
Condition Aggravated
ORAL
18-Aug-2005
Page: 9
Manufacturer
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Synthroid
Triazolam
Ritalin
Phentermine
C
C
C
C
Date:05/15/98ISR Number: 3079178-0Report Type:Expedited (15-DaCompany Report #98D--10317
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization DAILY, ORAL
Initial or Prolonged
PT
Report Source
Product
Role
Pain In Extremity
Foreign
Ritalin
PS
Swelling
Health
Professional
Manufacturer
Route
ORAL
Date:05/20/98ISR Number: 3081539-0Report Type:Expedited (15-DaCompany Report #98CDN 10042
Age:16 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Alopecia
Fatigue
Pain In Extremity
Foreign
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
PS
Subcutaneous Haematoma
Other
Ventolin
C
Manufacturer
Route
Duration
ORAL
5 MG, BID,
ORAL
2
MON
Subcutaneous Nodule
Systemic Lupus
Erythematosus
Date:05/22/98ISR Number: 3083542-3Report Type:Expedited (15-DaCompany Report #98USA10731
Age:13 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
DAILY, ORAL
PT
Report Source
Product
Role
Menorrhagia
Other
Ritalin
PS
Manufacturer
Route
Duration
ORAL
Date:05/22/98ISR Number: 3083545-9Report Type:Expedited (15-DaCompany Report #98USA10723
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
20 MG, BID,
PT
Report Source
Product
Role
Blood Creatinine
Health
Ritalin
PS
Increased
Professional
Sertraline
Loratadine
C
C
Manufacturer
Route
Duration
ORAL
ORAL
Nephritis Interstitial
Date:05/26/98ISR Number: 3167664-4Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 700 MG (100
Initial or Prolonged
MG, 7 TIMES
Company Report #001-0916-970004
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Health
Carbamazepine
PS
Convulsion
Professional
Neurontin
(Gabapentin)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
Otitis Media
DAILY)
400 MG (100
MG, QID)
5
DAY
18-Aug-2005
Page: 10
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/26/98ISR Number: 3167667-XReport Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 700 MG (100
Initial or Prolonged
MG, 7 TIMES
Company Report #001-0916-970004
PT
Report Source
Product
Role
Manufacturer
Route
Convulsion
Health
Carbamazepine
PS
Otitis Media
Professional
Neurontin
(Gabapentin)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
DAILY)
400 MG (100
MG QID)
5
DAY
Date:05/28/98ISR Number: 3084833-2Report Type:Expedited (15-DaCompany Report #98D--10334
Age:46 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
60 MG, DAILY,
PT
Report Source
Product
Role
Headache
Foreign
Ritalin
PS
Monoparesis
Health
Nuclear Magnetic
Resonance Imaging
Abnormal
Professional
Other
Manufacturer
Route
ORAL
ORAL
Date:05/29/98ISR Number: 3085978-3Report Type:Direct
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
10 MG TID
PT
Company Report #
Report Source
Product
Role
Ritalin
PS
Duration
Dyskinesia
Manufacturer
Route
Date:06/01/98ISR Number: 3088623-6Report Type:Expedited (15-DaCompany Report #98USA10749
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
DAILY,
PT
Report Source
Product
Role
Renal Failure
Other
Ritalin
PS
Manufacturer
Route
Manufacturer
Route
Duration
Renal Tubular Necrosis
INTRANASAL
Date:06/09/98ISR Number: 3091168-0Report Type:Expedited (15-DaCompany Report #98GB-10522
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
5MG BID ORAL
PT
Report Source
Product
Role
Depression
Foreign
Ritalin
PS
Suicide Attempt
Health
Professional
ORAL
Date:06/10/98ISR Number: 3091704-4Report Type:Expedited (15-DaCompany Report #98HQ 10208
Age:57 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization INTRAVENOUS
DAILY
Initial or Prolonged
INTRAVENOUS
18-Aug-2005
Page: 11
11:49 AM
PT
Report Source
Product
Role
Condition Aggravated
Foreign
Ritalin
PS
Cough
Literature
Pulmonary Granuloma
Pyrexia
Silicon Granuloma
Health
Professional
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/11/98ISR Number: 3096322-XReport Type:Periodic
Age:51 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
10 MG ORAL
Company Report #97-11-0589
PT
Report Source
Product
Role
Manufacturer
Route
Dizziness
Drug Interaction
Consumer
Claritin
(Loratadine) Tablets
PS
ORAL
Ritalin
SS
ORAL
Duration
1
Flushing
DOSE
Headache
PO
Hypertension
Nausea
Nervousness
Tremor
Date:06/16/98ISR Number: 3094143-5Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Required
2-3 TIMES
Intervention to
DAILY
Prevent Permanent
1-2 DAILY
Impairment/Damage
PT
Company Report #
Report Source
Abnormal Behaviour
Product
Role
Ritalin
PS
Clonidine
SS
Manufacturer
Route
Manufacturer
Route
Cough
Depressed Level Of
Consciousness
Dermatitis
Emotional Disorder
Growth Retardation
Insomnia
Mood Swings
Muscle Twitching
Nervousness
Sedation
Date:06/16/98ISR Number: 3094976-5Report Type:Expedited (15-DaCompany Report #98HQ-10219
Age:30 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Hospitalization 100 MG, DAILY
Initial or Prolonged
Abdominal Pain
Foreign
Drug Withdrawal Syndrome
Suicidal Ideation
Literature
Health
Professional
Ritalin
PS
Date:06/19/98ISR Number: 3096692-2Report Type:Expedited (15-DaCompany Report #98HQ-10221
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization DAILY
Initial or Prolonged
PT
Report Source
Product
Role
Depressed Mood
Literature
Ritalin
PS
Drug Ineffective
Emotional Distress
Mood Altered
Suicidal Ideation
Health
Professional
Sertraline
C
Manufacturer
Route
Manufacturer
Route
Date:06/19/98ISR Number: 3096702-2Report Type:Expedited (15-DaCompany Report #98HQ-10221
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization 3
DAY
Initial or Prolonged
18-Aug-2005
Page: 12
11:49 AM
PT
Report Source
Product
Role
Bipolar Disorder
Literature
Ritalin
PS
Depressed Mood
Emotional Distress
Suicidal Ideation
Health
Professional
Sertraline
C
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/19/98ISR Number: 3096703-4Report Type:Expedited (15-DaCompany Report #98HQ-10217
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
DAILY
PT
Report Source
Product
Role
Arrhythmia
Literature
Ritalin
PS
Grand Mal Convulsion
Syncope
Tic
Transient Ischaemic
Attack
Health
Professional
Clonidine
SS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
Date:06/19/98ISR Number: 3096712-5Report Type:Expedited (15-DaCompany Report #98HQ-10217
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Grand Mal Convulsion
Syncope
Tic
Health
Professional
Ritalin
Clonidine
PS
SS
Duration
Date:06/19/98ISR Number: 3096914-8Report Type:Expedited (15-DaCompany Report #98HQ-10209
Age:57 YR
Gender:Male
I/FU:F
Outcome
PT
Dose
Duration
Hospitalization Condition Aggravated
INTRAVENOUS
DAILY,
Initial or Prolonged
Cough
INTRAVENOUS
Dyspnoea
Pulmonary Granuloma
Pyrexia
Report Source
Product
Role
Foreign
Ritalin
PS
Literature
Health
Professional
Date:06/19/98ISR Number: 3096917-3Report Type:Expedited (15-DaCompany Report #98HQ-10220
Age:39 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Hospitalization Drug Abuser
INTRAVENOUS
DAILY,
Initial or Prolonged
Neovascularisation
INTRAVENOUS
Other
Retinal Exudates
INTRAVENOUS
INTRAVENOUS
Retinal Haemorrhage
Retinopathy
Vision Blurred
Literature
Ritalin
PS
Talwin
SS
Heroin
C
Health
Professional
Date:06/19/98ISR Number: 3096918-5Report Type:Expedited (15-DaCompany Report #J980990
Age:57 YR
Gender:Male
I/FU:I
Outcome
PT
Dose
Duration
Hospitalization Chest X-Ray Abnormal
INTRAVENOUS
INTRAVENOUS
Initial or Prolonged
Condition Aggravated
Cough
Dyspnoea
Pulmonary Granuloma
Pyrexia
Date:06/24/98ISR Number: 3098700-1Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Other
18-Aug-2005
Page: 13
PT
Aggression
Amnesia
11:49 AM
Report Source
Product
Role
Literature
Ritalin
PS
Health
Professional
Company Report #
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disturbance In Social
Behaviour
Drug Effect Decreased
Dose
Report Source
Product
Role
Manufacturer
Route
Methylphenidate Hcl
PS
Danbury
ORAL
Duration
1@ 730A PO 1@
12NOON
2
MON
Date:06/24/98ISR Number: 3098866-3Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
2 TABS @ 730A
Company Report #
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Health
Ritalin (Generic)
PS
Danbury
ORAL
Educational Problem
Professional
Route
PO; 1 1/2 TAB
@ 1130A PM;
1@410O PO;
STRARTED
Date:06/24/98ISR Number: 3098870-5Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
1@8A,
1/2@4P;1@12N
Company Report #
PT
Report Source
Product
Role
Manufacturer
Abdominal Pain Upper
Health
Methylphenidate
PS
Danbury
Abnormal Behaviour
Professional
Duration
2
MON
Memory Impairment
Restlessness
Date:06/24/98ISR Number: 3098871-7Report Type:Direct
Age:
Gender:Female
I/FU:I
Company Report #
Outcome
Dose
Duration
Other
1@8A; 1/2 @3
PT
Report Source
Aggression
Product
Role
Manufacturer
Route
Methylphenidate
PS
Danbury
ORAL
Manufacturer
Route
Social Avoidant Behaviour
PO
2
MON
Date:06/25/98ISR Number: 3098541-5Report Type:Expedited (15-DaCompany Report #83505
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization 20 MG 1 X ONE
Initial or Prolonged
DOSE ORAL
PT
Report Source
Product
Role
Dehydration
Literature
Midazolam
PS
Ritalin
SS
Ketamine
SS
Midazolam
Hydrochloride
SS
*
C
ORAL
Drug Effect Decreased
Drug Ineffective
5 MG 2 X PER
Drug Interaction
DAY
Lethargy
60 MG 1 X PER
Medication Error
ONE DOSE
INTRAVENOUS
Nausea
Overdose
5 MG 1 X PER
Vomiting
ONE DOSE
INTRAVENOUS
Date:06/30/98ISR Number: 3100716-3Report Type:Expedited (15-DaCompany Report #98D-10222
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
15 MG, BID,
PT
Report Source
Product
Role
Thrombocythaemia
Foreign
Ritalin
PS
Health
ORAL
40
DAY
Professional
18-Aug-2005
Page: 14
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/07/98ISR Number: 3102770-1Report Type:Expedited (15-DaCompany Report #98D--10317
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization 10 MG, TID,
Initial or Prolonged
ORAL
PT
Report Source
Product
Role
Arthralgia
Foreign
Ritalin
PS
Arthritis
Health
Manufacturer
Route
ORAL
Professional
Other
Date:07/07/98ISR Number: 3185379-3Report Type:Periodic
Age:40 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
Company Report #AR-1040
PT
Report Source
Product
Role
Manufacturer
Route
Blood Pressure Increased
Chest Discomfort
Drug Ineffective
Consumer
Methylphenidate Hci
Tablets 10 Mg
(Danbury/Schein)
PS
Danbury/Schein
ORAL
Prozac
Clonipin
Inhaler
C
C
C
Manufacturer
Route
Duration
40MG/DAY
Hypoaesthesia
(ORAL)
Nausea
Palpitations
Panic Attack
Date:07/08/98ISR Number: 3104178-1Report Type:Direct
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
25 MG BID PO
PT
PT
Duration
Report Source
Drug Effect Decreased
Date:07/21/98ISR Number: 3108440-8Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #
Product
Role
Ritalin
PS
ORAL
Company Report #
Report Source
Product
Role
Manufacturer
Route
Other
PO BID
Swelling
Ritalin
PS
Weight Increased
Loxapine
C
Date:07/28/98ISR Number: 3113159-3Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
PT
Janssen
ORAL
Manufacturer
Route
Manufacturer
Route
Company Report #
Report Source
Product
Role
Ritalin
PS
Duration
Drug Effect Decreased
20MG 4 PER
DAY
Date:07/31/98ISR Number: 3181709-7Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Other
ORAL
Company Report #8-97364-028B
PT
Report Source
Product
Role
Chest Pain
Consumer
Pondimin
PS
Effexor
SS
Phentermine
Ritalin
Erall
Effexor
Phentermine
Ritalin
SS
SS
C
C
C
C
Duration
Dyspnoea
150 MG
18-Aug-2005
Page: 15
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/03/98ISR Number: 3112492-9Report Type:Expedited (15-DaCompany Report #98USA10723
Age:17 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Other
20MG,BID,ORAL
PT
Report Source
Product
Role
Blood Creatinine
Health
Ritalin
PS
Increased
Nephritis Interstitial
Professional
Pseudoephedrine
Ibuprofen
Ceftin
Zoloft
Growth Hormone
Unknown
Zyrtec
Claritin
Sertraline
Loratadine
C
C
C
C
Manufacturer
Route
ORAL
C
C
C
C
C
Date:08/04/98ISR Number: 3112488-7Report Type:Expedited (15-DaCompany Report #98GB-10779
Age:
Gender:Male
I/FU:I
Outcome
Dose
Death
DAILY,
PT
Report Source
Product
Role
Hepatic Neoplasm
Foreign
Ritalin
PS
Manufacturer
Route
Manufacturer
Route
Duration
Health
Professional
Other
Date:08/04/98ISR Number: 3226773-1Report Type:Periodic
Age:20 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Drug Abuser
Consumer
Methylphenidate
Hydrochloride
Extended-Release
Tablets Usp, 20 Mg
PS
Duration
12 TABLETS
DAILY (240 MG
ER), PO 3.5
Company Report #MPI-98182
ORAL
YEARS
Effexor
Date:08/05/98ISR Number: 3113328-2Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
20 MG SR PO
C
Company Report #
PT
Report Source
Product
Role
Drug Effect Decreased
Health
Methylphenidate
PS
Manufacturer
Route
Duration
ORAL
Professional
/
10MG PO
Date:08/09/98ISR Number: 3185364-1Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
10.00 MG
Company Report #9807623
PT
Report Source
Product
Role
Alopecia
Health
Zyrtec Tablets
PS
Drug Interaction
Professional
Ritalin
SS
TOTAL; DAILY;
Company
ORAL; SEVERAL
Representative
MONTHS
18-Aug-2005
Page: 16
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/11/98ISR Number: 3115530-2Report Type:Expedited (15-DaCompany Report #98-07-444
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Death
30MG, 1440 MG
Other
PSEUDOEPHEDRI
PT
Report Source
Product
Role
Manufacturer
Route
Intentional Misuse
Consumer
Sudafed
PS
ORAL
Alcohol
SS
ORAL
Antihypertensive
SS
ORAL
Ritalin
SS
ORAL
NE; ORAL
UNK; ORAL
UNK; ORAL
UNK; ORAL
Date:08/18/98ISR Number: 3118737-3Report Type:Expedited (15-DaCompany Report #98GB-10779
Age:
Gender:
I/FU:F
Outcome
Dose
Death
DAILY
PT
Report Source
Product
Role
Sarcoma
Foreign
Ritalin
PS
Manufacturer
Route
Manufacturer
Route
Duration
Health
Professional
Date:08/21/98ISR Number: 3120455-2Report Type:Expedited (15-DaCompany Report #98GB 10779
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
55 MG DAILY
PT
Report Source
Product
Role
Abdominal Pain
Foreign
Ritalin
PS
Ascites
Health
Fibrosarcoma
Hepatic Neoplasm
Malignant
Pleural Effusion
Weight Decreased
Professional
Duration
ORAL
ORAL
Date:08/25/98ISR Number: 3122062-4Report Type:Expedited (15-DaCompany Report #98HQ-10328
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Death
20 MG, DAILY
PT
Report Source
Product
Role
Anorexia
Foreign
Ritalin
PS
Brain Herniation
Literature
Pemoline
SS
Brain Oedema
Health
Cholestasis
Encephalopathy
Eosinophilia
Fatigue
Hepatic Necrosis
Hepatomegaly
Jaundice
Liver Function Test
Abnormal
Liver Tenderness
Liver Transplant
Rejection
Necrosis
Renal Failure Acute
Weight Decreased
Professional
37.5 MG,
DAILY
18-Aug-2005
Page: 17
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/27/98ISR Number: 3124026-3Report Type:Direct
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Methylphenidate
Hydrochlomide Sr
PS
Methylphenidite
Hydrochloride
SS
Manufacturer
Route
Duration
Drug Ineffective
1T AM
ORAL
2T 3:30PM
Date:08/28/98ISR Number: 3123480-0Report Type:Expedited (15-DaCompany Report #8-98187-014A
Age:40 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Required
150 MG THREE
Intervention to
TIMES DAILY
Prevent Permanent
ORAL
Impairment/Damage
5 MG THREE
PT
Report Source
Product
Role
Manufacturer
Route
Abortion Spontaneous
Health
Effexor Xr
PS
ORAL
Complications Of Maternal
Professional
Ritalin
SS
ORAL
Synthroid
SS
ORAL
Ritalin
Synthroid
C
C
Exposure To Therapeutic
Drugs
TIMES DAILY
ORAL
0.1 MG DAILY
ORAL
Date:09/03/98ISR Number: 3125679-6Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Other
1 PO TID
PT
Company Report #
Report Source
Product
Role
Ritalin
PS
Manufacturer
Route
Duration
Abdominal Pain Upper
2
YR
ORAL
Date:09/04/98ISR Number: 3126263-0Report Type:Expedited (15-DaCompany Report #98USA11254
Age:17 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization 10 MG TID
Initial or Prolonged
ORAL
PT
Report Source
Product
Role
Aggression
Health
Ritalin
PS
ORAL
Emotional Disorder
Professional
Adderall 20
SS
ORAL
Psychotic Disorder
Manufacturer
Route
60 MG DAILY
ORAL
Date:09/09/98ISR Number: 3126562-2Report Type:Direct
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
20 MG SR, 1 Q
PT
Company Report #
Report Source
Drug Ineffective
Product
Role
Methylphenidate
PS
Manufacturer
Route
Manufacturer
Route
AM AND 10 MG
AM + AFT
Date:09/11/98ISR Number: 3127686-6Report Type:Expedited (15-DaCompany Report #98USA11287
Age:91 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization DAILY, ORAL
Initial or Prolonged
18-Aug-2005
Page: 18
11:49 AM
PT
Report Source
Product
Role
Urinary Tract Obstruction
Health
Ritalin
PS
Professional
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/14/98ISR Number: 3130221-XReport Type:Expedited (15-DaCompany Report #98USA 11335
Age:40 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
5 MG, TID,
Required
ORAL
Intervention to
.1MG, DAILY,
Prevent Permanent
ORAL
Impairment/Damage
450 MG,
PT
Report Source
Product
Role
Manufacturer
Route
Abortion Spontaneous
Health
Ritalin
PS
ORAL
Complications Of Maternal
Professional
Exposure To Therapeutic
Other
Synthroid
SS
ORAL
Effexor
SS
ORAL
Drugs
Pain
DAILY, ORAL
Date:09/18/98ISR Number: 3132770-7Report Type:Expedited (15-DaCompany Report #1998-09-0369
Age:46 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization 3 MU TIW
Initial or Prolonged
1200 MG QD
PT
Report Source
Product
Role
Manufacturer
Route
Acute Psychosis
Study
Intron A
PS
ORAL
Aggression
Health
Ribavirin
SS
ORAL
Confusional State
Professional
Memory Impairment
Ritalin
SS
ORAL
Speech Disorder
Prozac
SS
ORAL
Buspar
SS
ORAL
Ampicillin
C
ORAL
ORAL
ORAL
ORAL
Date:09/18/98ISR Number: 3133033-6Report Type:Expedited (15-DaCompany Report #USA004414
Age:40 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Required
100 MCG OD PO
Intervention to
5 MG TID PO
Prevent Permanent
150 MG TID
Impairment/Damage
PO, 150 MG OD
Abdominal Pain Lower
Health
Synthroid
PS
ORAL
Abortion Spontaneous
Professional
Ritalin
SS
ORAL
Twin Pregnancy
Other
Effexor
SS
PO-SEE IMAGE
Date:09/21/98ISR Number: 3133873-3Report Type:Expedited (15-DaCompany Report #98USA11381
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization DAILY, ORAL
Initial or Prolonged
PT
Report Source
Product
Role
Amnesia
Health
Ritalin
PS
Confusional State
Laboratory Test Abnormal
Mental Impairment
Professional
Date:09/28/98ISR Number: 3233550-4Report Type:Periodic
Age:57 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
5.00 MG
Manufacturer
Route
ORAL
Company Report #9714665
PT
Report Source
Product
Role
Manufacturer
Route
Anxiety
Consumer
Norvasc Tablets
PS
ORAL
Ritalin
SS
ORAL
Dexedrine
SS
ORAL
Ativan
Xanax
Ventolin
C
C
C
Duration
Attention
TOTAL:DAILY:O
Deficit/Hyperactivity
RAL
Disorder
15.00 MG
Depression
TOTAL:TID:ORA
Hypertension
L
Myalgia
15.00 MG
TOTAL:TID:ORA
L
18-Aug-2005
Page: 19
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Zocor
Date:09/29/98ISR Number: 3136504-1Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
7.5 MG QID
Company Report #
PT
Report Source
Product
Role
Attention
Health
Ritalin
PS
Deficit/Hyperactivity
Disorder
Condition Aggravated
Excitability
Professional
Manufacturer
Route
Route
Duration
Date:09/29/98ISR Number: 3136589-2Report Type:Direct
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
2 GM, - 1
C
PT
Company Report #
Report Source
Product
Role
Manufacturer
Methylphenidate
PS
Schein
Manufacturer
Duration
Drug Ineffective
Psychomotor Hyperactivity
NOON, 1 @ 3
PM:NDC#0364-0
561-01
Date:10/01/98ISR Number: 3137282-2Report Type:Expedited (15-DaCompany Report #98D-10831
Age:8 YR
Gender:Male
I/FU:I
Outcome
PT
Dose
Duration
Hospitalization Bronchospasm
1 DF TID ORAL 3
MON
Initial or Prolonged
Hallucination
Status Asthmaticus
Report Source
Product
Role
Foreign
Ritalin
PS
Health
Professional
Other
Route
ORAL
Date:10/08/98ISR Number: 3140263-6Report Type:Expedited (15-DaCompany Report #98D-10860
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
15 MG, DAILY,
PT
Report Source
Product
Role
Eyelid Oedema
Foreign
Ritalin
PS
Face Oedema
Health
Rash Macular
Professional
Manufacturer
Route
ORAL
ORAL
Date:10/08/98ISR Number: 3260757-2Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
10.00 MG
Company Report #9828157
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Zyrtec Tablets
PS
ORAL
Ritalin
SS
ORAL
Clonidine
C
Duration
Anorexia
TOTAL;DAILY;O
Diarrhoea
RAL
Drug Ineffective
15.00 MG
Thinking Abnormal
TOTAL;TID;ORA
L
18-Aug-2005
Page: 20
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/08/98ISR Number: 3262241-9Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
10.00 MG
Company Report #9807623
PT
Report Source
Product
Role
Manufacturer
Route
Alopecia
Health
Zyrtec Tablets
PS
ORAL
Drug Interaction
Professional
Ritalin
SS
ORAL
Duration
TOTAL:DAILY:O
RAL
7.50 MG
TOTAL:DAILY:O
RAL
Date:10/13/98ISR Number: 3141051-7Report Type:Expedited (15-DaCompany Report #98HQ-10359
Age:42 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 120MG DAILY
Initial or Prolonged
ORAL
PT
Report Source
Product
Role
Anxiety
Foreign
Ritalin
PS
Cerebral Atrophy
Literature
Depression
Drug Dependence
Drug Withdrawal Syndrome
Electroencephalogram
Abnormal
Malaise
Movement Disorder
Nuclear Magnetic
Resonance Imaging
Abnormal
Palpitations
Panic Attack
Respiratory Distress
Social Phobia
Suicidal Ideation
Thought Blocking
Health
Professional
Other
Manufacturer
Route
ORAL
Date:10/19/98ISR Number: 3142785-0Report Type:Direct
Age:19 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Life-Threatening
5 MG
PT
Company Report #
Report Source
Convulsion
Product
Role
Manufacturer
Ritalin
PS
Mfg: Ciba Gigy
Dilantin
Phenobarb
Pepcid
C
C
C
Route
Date:10/19/98ISR Number: 3143306-9Report Type:Expedited (15-DaCompany Report #98D--10831
Age:8 YR
Gender:Male
I/FU:F
Outcome
PT
Dose
Duration
Hospitalization Bronchospasm
25 MG DAILY
Initial or Prolonged
Status Asthmaticus
ORAL
3
MON
Report Source
Product
Role
Foreign
Ritalin
PS
Manufacturer
Route
ORAL
Health
Professional
Date:10/19/98ISR Number: 3143903-0Report Type:Direct
Age:17 YR
Gender:
I/FU:I
Outcome
Dose
Duration
Other
1.5 TAB BID,
1 TAB AFTER
SCHOOL
18-Aug-2005
Page: 21
11:49 AM
PT
Drug Ineffective
Company Report #
Report Source
Product
Role
Manufacturer
Route
Methylphenidate
PS
Schein
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/19/98ISR Number: 3143905-4Report Type:Direct
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
1.5 TAB QAM,
PT
Company Report #
Report Source
Drug Ineffective
Product
Role
Manufacturer
Route
Methylphenidate
PS
Schein
ORAL
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
1 TAB AT NOON
Date:10/22/98ISR Number: 3144917-7Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
20 MG/ TAB/ 1
Company Report #
PT
Report Source
Product
Role
Drug Ineffective
Health
Methylphenidate
PS
Ritalin
C
Professional
TID
Date:10/26/98ISR Number: 3146467-0Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
20 MG., 1 TID
PT
Company Report #
Report Source
Drug Ineffective
Product
Role
Methylphenidate
PS
Ritalin
C
TAB
Date:10/26/98ISR Number: 3147013-8Report Type:Expedited (15-DaCompany Report #98USA11530
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Required
DAILY, ORAL
Intervention to
Prevent Permanent
PT
Report Source
Product
Role
Overdose
Health
Ritalin
PS
Professional
ORAL
Impairment/Damage
Date:10/27/98ISR Number: 3243926-7Report Type:Periodic
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
5.00 MG
Company Report #9820743
PT
Report Source
Product
Role
Manufacturer
Apathy
Consumer
Zyrtec Syrup
PS
ORAL
Ritalin
SS
ORAL
Route
Duration
Emotional Disorder
TOTAL:PRN:ORA
L
ORAL
Date:10/30/98ISR Number: 3150426-1Report Type:Expedited (15-DaCompany Report #98USA11335
Age:40 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Other
10MG, TIDI,
Required
ORAL
Intervention to
1 MG, DAILY,
Prevent Permanent
ORAL
Impairment/Damage
375 MG,
DAILY, ORAL
18-Aug-2005
Page: 22
11:49 AM
PT
Report Source
Product
Role
Abortion Spontaneous
Health
Ritalin
PS
ORAL
Pain
Professional
Synthroid
SS
ORAL
Effexor
SS
ORAL
Other
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/03/98ISR Number: 3151245-2Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Methylphenidate
PS
Aspirin
C
Manufacturer
Route
Duration
Burning Sensation
ORAL
5MG PO Q AM ,
Dermatitis
5 MG PO Q__
Rash Papular
Rash Vesicular
Date:11/04/98ISR Number: 3152005-9Report Type:Direct
Age:10 MON Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Ritalin
PS
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
10MG QID
Date:11/17/98ISR Number: 3160554-2Report Type:Expedited (15-DaCompany Report #98USA11679
Age:47 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abdominal Pain
Burning Sensation
Chest Wall Pain
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
PS
ORAL
10 MG BID
Liver Function Test
ORAL
Abnormal
Odynophagia
Date:11/19/98ISR Number: 3161209-0Report Type:Direct
Age:41 YR
Gender:Female
I/FU:I
Outcome
Dose
Disability
20 MG QID
PT
Company Report #
Report Source
Product
Role
Manufacturer
Methylphenidate Hcl
PS
Novartis
Duration
Agitation
Route
Other
(4X DA)
Anxiety
Asthenia
Depression
Disturbance In Attention
Drug Ineffective
Prozac
Zyprexia
Klonopin
C
C
C
Date:11/23/98ISR Number: 3163255-XReport Type:Expedited (15-DaCompany Report #98USA11589
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
65 MG, DAILY,
PT
Report Source
Product
Role
Body Height Below Normal
Health
Methylphenidate
PS
Brain Damage
Professional
Tylenol Talbet
C
Manufacturer
Route
ORAL
ORAL
Headache
Nausea
Reading Disorder
Date:11/24/98ISR Number: 3162993-2Report Type:Direct
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #
PT
Report Source
Product
Role
Psychomotor Hyperactivity
Health
Methylphenidate Hcl
PS
Duration
15MG @ 800;
Professional
10MG @ 1200 &
1600
18-Aug-2005
Page: 23
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/01/98ISR Number: 3164971-6Report Type:Direct
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
15 MG PO BID
PT
Company Report #
Report Source
Drug Ineffective
Date:12/02/98ISR Number: 3165975-XReport Type:Direct
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
15MG PO BID
Product
Role
Ritalin
PS
Manufacturer
Route
ORAL
Company Report #
PT
Report Source
Product
Role
Drug Ineffective
Health
Ritalin
PS
Manufacturer
Route
Duration
ORAL
Professional
Date:12/07/98ISR Number: 3168246-0Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Company Report #
PT
Report Source
Product
Role
Drug Ineffective
Health
Professional
Ritalin
PS
Manufacturer
Route
Manufacturer
Route
Duration
Date:12/09/98ISR Number: 3169099-7Report Type:Expedited (15-DaCompany Report #98D--10860
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Other
15 MG, DAILY,
PT
Report Source
Product
Role
Eyelid Oedema
Foreign
Ritalin
PS
Face Oedema
Health
Rash Generalised
Rash Macular
Professional
ORAL
Date:12/16/98ISR Number: 3290754-2Report Type:Periodic
Age:34 YR
Gender:Female
I/FU:I
Company Report #93396
ORAL
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Mental Impairment
Other
Valium (Diazepam)
5.000 Mg
PS
ORAL
Klonopin Tablets
(Clonazepam) 1.000mg
SS
ORAL
Prozac (Fluoxetine)
20 Mg
SS
ORAL
Zoloft (Sertraline
Hydrochloride)
100.00 Mg
SS
ORAL
Paxil (Paroxetine)
20 Mg
SS
ORAL
Nortriptyline
(Nortriptyline
Hydrochloride) 50.00
Mg
SS
ORAL
Methylphenidate
(Methylphenidate
Hydrochloride) 10.00
Mg
SS
ORAL
Duration
5 MG DAILY
ORAL
1 MG DAILY
ORAL
20 MG DAILY
ORAL
100 MG 5 X
PER DAY ORAL
10 MG DAILY
ORAL
50 MG DAILY
ORAL
10 MG DAILY
18-Aug-2005
Page: 24
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
ORAL
Date:12/21/98ISR Number: 3172602-4Report Type:Expedited (15-DaCompany Report #98USA11815
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
20 MG BID,
PT
Report Source
Product
Role
Coma
Health
Ritalin-Sr
PS
Eye Rolling
Professional
Remeron Tablet
..
..
C
C
C
Manufacturer
Route
Duration
ORAL
ORAL
Syncope
Date:01/07/99ISR Number: 3177675-0Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Ritalin
PS
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
30 MG QD
Date:01/08/99ISR Number: 3179055-0Report Type:Direct
Age:14 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
5 MG Q AM +
Company Report #
PT
Report Source
Product
Role
Anxiety
Health
Ritalin
PS
Depressed Level Of
Professional
Depakote
Prozac
C
C
Duration
NOON
Consciousness
Hallucination, Auditory
Headache
Tremor
Vision Blurred
ORAL
Date:01/11/99ISR Number: 3179585-1Report Type:Expedited (15-DaCompany Report #98D--11041
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization 10 MG DAILY,
Initial or Prolonged
ORAL
Other
PT
Report Source
Product
Role
Angioneurotic Oedema
Foreign
Ritalin
PS
Manufacturer
Route
ORAL
Health
Professional
Other
Date:01/13/99ISR Number: 3180308-0Report Type:Expedited (15-DaCompany Report #99CDN10013
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Disability
15MG, BID,
PT
Report Source
Product
Role
Diplopia
Foreign
Ritalin
PS
Manufacturer
Route
Duration
ORAL
Other
ORAL
Date:01/15/99ISR Number: 3181050-2Report Type:Direct
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Manufacturer
Route
Methylphenidate
PS
Schien
ORAL
Duration
Abnormal Behaviour
TABLETS/ORAL
Nightmare
7 1/2MG AM &
NOON
18-Aug-2005
Page: 25
Company Report #
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/21/99ISR Number: 3183216-4Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
20MG TID
PT
Company Report #
Report Source
Product
Role
Ritalin
PS
Manufacturer
Route
Manufacturer
Route
Duration
Anorexia
Crying
BEGAN AT
Depression
40MG-60MG
Headache
SEVERE
3
MON
Nausea
Weight Decreased
Date:01/21/99ISR Number: 3183735-0Report Type:Expedited (15-DaCompany Report #98D--11041
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization 10 MG, DAILY,
Initial or Prolonged
ORAL
Other
PT
Report Source
Product
Role
Angioneurotic Oedema
Foreign
Ritalin
PS
Oedema Peripheral
Health
ORAL
Professional
Date:01/22/99ISR Number: 3184611-XReport Type:Expedited (15-DaCompany Report #98USA10035
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Blood Creatine
Phosphokinase Increased
Chest Pain
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
DAILY ORAL
Date:01/25/99ISR Number: 3198616-6Report Type:Periodic
Age:
Gender:Female
I/FU:F
Company Report #9820743
Manufacturer
Route
ORAL
Outcome
Dose
Other
5.00 MG
PT
Report Source
Product
Role
Manufacturer
Route
Apathy
Consumer
Zyrtec Syrup
PS
ORAL
Emotional Disorder
Health
Ritalin
SS
ORAL
Duration
TOTAL:PRN:ORA
Professional
L
ORAL
Date:01/27/99ISR Number: 3186639-2Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
5MG QAM
PT
Company Report #
Report Source
Product
Role
Manufacturer
Generic Ritalin
PS
Schien
Manufacturer
Route
Duration
Tic
Date:01/27/99ISR Number: 3186812-3Report Type:Expedited (15-DaCompany Report #1999-000075
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Route
Accommodation Disorder
Binocular Eye Movement
Foreign
Other
Clonidine
Hydrochloride
PS
ORAL
Ritalin
SS
ORAL
Duration
PO
Disorder
5 MG PO
39
MON
Condition Aggravated
Visual Disturbance
18-Aug-2005
Page: 26
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/29/99ISR Number: 3188498-0Report Type:Expedited (15-DaCompany Report #1999-000075
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Accommodation Disorder
Binocular Eye Movement
Foreign
Other
Clonidine
Hydrochloride
PS
ORAL
Ritalin
SS
ORAL
Duration
PO
Disorder
5 MG;
PO
39
MON
Condition Aggravated
Visual Disturbance
Date:01/29/99ISR Number: 3188605-XReport Type:Expedited (15-DaCompany Report #99HQ-10010
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 1000 MG,
Initial or Prolonged
DAILY
PT
Report Source
Product
Role
Drug Interaction
Literature
Carbamazepine
PS
Methylphenidate
Unknown
(Methylphenidate)
Thiothixene Unknown
SS
C
Manufacturer
Route
Manufacturer
Route
Health
Professional
Date:02/01/99ISR Number: 3189575-0Report Type:Expedited (15-DaCompany Report #99USA10081
Age:51 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Disability
10 MG QD ORAL 2
WK
PT
Report Source
Product
Role
Tinnitus
Health
Ritalin
PS
ORAL
Professional
Date:02/01/99ISR Number: 3189577-4Report Type:Expedited (15-DaCompany Report #97USA11732
Age:50 YR
Gender:Male
I/FU:F
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Life-Threatening
Cerebrovascular Accident
60 MG, QD
Hospitalization Haemorrhage Intracranial
ORAL
14
MON
Initial or Prolonged
Hypertension
Ruptured Cerebral
Aneurysm
Health
PS
Company Report #7394727
PT
Report Source
Product
Role
Manufacturer
Route
Aspartate
Health
Abbott-Cylert
PS
Abbott
ORAL
Aminotransferase
Professional
Increased
Ritalin
SS
Blood Lactate
Dehydrogenase Increased
Claritin
Ritalin
C
C
QD
20.000 MG QD
Date:02/03/99ISR Number: 3191349-1Report Type:Expedited (15-DaCompany Report #8-97199-009S
Age:39 YR
Gender:Female
I/FU:F
Outcome
Death
Life-Threatening
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 27
11:49 AM
ORAL
Professional
Date:02/01/99ISR Number: 3196882-4Report Type:Periodic
Age:27 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
37.500 MG PO
Ritalin
PT
Abdominal Distension
Ascites
Cardiac Failure
Congestive
Cardiac Murmur
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Cardiogenic Shock
Cardiomegaly
Cough
Report Source
Product
Role
Dyspnoea
Consumer
Pondimin
PS
ORAL
Ritalin
SS
ORAL
Cafergot
Estrogen
Klonopin
Lithium
Methyltestosterone
Synthroid
Triazolam
C
C
C
C
C
C
C
Manufacturer
Route
Duration
60 MG DAILY
Dyspnoea Exertional
ORAL
Electrocardiogram St
20 MG THREE
Segment Abnormal
TIMES DAILY
Fatigue
ORAL
Hepatic Function Abnormal
Hepatomegaly
Hypoxia
Malaise
Mania
Mitral Valve Incompetence
Oedema Peripheral
Orthopnoea
Pneumonia
Postnasal Drip
Pulmonary Hypertension
Pyrexia
Respiratory Failure
Right Ventricular Failure
Sinusitis
Tricuspid Valve
Incompetence
Weight Decreased
Date:02/04/99ISR Number: 3197993-XReport Type:Periodic
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
DAILY ORAL
Company Report #98USA10490
PT
Report Source
Product
Role
Convulsion
Consumer
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
Date:02/04/99ISR Number: 3197999-0Report Type:Periodic
Age:30 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
10 MG TID
Company Report #98USA11678
PT
Report Source
Product
Role
Aggression
Euphoric Mood
Health
Professional
Methylphenidate
Tablet 10 Mg
PS
Paxil Capsule
Clonidine Tablet
C
C
Manufacturer
Route
ORAL
Jaundice
ORAL
Liver Disorder
Psychotic Disorder
Date:02/04/99ISR Number: 3404468-9Report Type:Periodic
Age:52 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11402
PT
Report Source
Product
Role
Dizziness
Hypertension
Metanephrine Urine
Increased
Health
Professional
Ritalin Tablet
Unknown
(Methylphenidate
Hydrochloride)
PS
Zoloft Tablet
Effexor Tablet
///Zodone Tablet
Buspar Tablet
Iron Tablet
C
C
C
C
C
DAILY, ORAL
Palpitations
18-Aug-2005
Page: 28
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3404474-4Report Type:Periodic
Age:
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11404
PT
Report Source
Product
Role
Psychotic Disorder
Other
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3404479-3Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11405
PT
Report Source
Product
Role
Psychotic Disorder
Consumer
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3404483-5Report Type:Periodic
Age:47 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11406
PT
Report Source
Product
Role
Bursitis
Carpal Tunnel Syndrome
Intervertebral Disc
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Xanax Tablet
Effexor Tablet
Zyrtec Tablet
Prilosec Tablet
C
C
C
C
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Disorder
Date:02/04/99ISR Number: 3404486-0Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11409
PT
Report Source
Product
Dysphonia
Health
Professional
Ritalin Tablet
(Methylphenidate
Duration
Role
Manufacturer
Route
Hydrochloride)
PS
ORAL
Ritalin-Sr Slow
Release Tablet 20
(Methylphenidate
Hydrochloride)
SS
ORAL
Claritin Tablet
C
12.5 MG, TID,
ORAL
20 MG, DAILY,
ORAL
Date:02/04/99ISR Number: 3404488-4Report Type:Periodic
Age:23 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11411
PT
Report Source
Product
Role
Palpitations
Restlessness
Tachycardia
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3404491-4Report Type:Periodic
Age:48 YR
Gender:Male
I/FU:I
Outcome
Dose
18-Aug-2005
Page: 29
Company Report #98USA11423
PT
Report Source
Product
Drug Level Above
Therapeutic
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Duration
11:49 AM
Role
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hydrochloride)
PS
Sudafed Tablet
Ibuprofen Tablet
C
C
ORAL
5 MG, TID,
ORAL
Date:02/04/99ISR Number: 3404493-8Report Type:Periodic
Age:65 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11442
PT
Report Source
Product
Role
Hyponatraemia
Inappropriate
Antidiuretic Hormone
Health
Professional
Methylphenidate
Tablet 5 Mg
(Methylphenidate)
PS
Colace Capsule
Pepcid Tablet
C
C
Manufacturer
Route
Duration
ORAL
5 MG, BID,
Secretion
ORAL
Date:02/04/99ISR Number: 3404495-1Report Type:Periodic
Age:47 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11443
PT
Report Source
Product
Role
Pelvic Pain
Pollakiuria
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
30 MG, DAILY,
ORAL
Date:02/04/99ISR Number: 3404496-3Report Type:Periodic
Age:46 YR
Gender:Female
I/FU:I
Outcome
Dose
DAILY, ORAL
Company Report #98USA11445
PT
Report Source
Product
Role
Hypoaesthesia
Joint Stiffness
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
Date:02/04/99ISR Number: 3404497-5Report Type:Periodic
Age:60 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11456
PT
Report Source
Product
Role
Manufacturer
Route
Arthralgia
Fatigue
Headache
Consumer
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
ORAL
Imipramine Tablet
(Imipramine)
SS
ORAL
Alprazolam Tablet
C
Duration
DAILY, ORAL
Nightmare
Pain
ORAL
Date:02/04/99ISR Number: 3404500-2Report Type:Periodic
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Decreased Appetite
Nausea
Weight Decreased
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
25 MG, BID,
ORAL
18-Aug-2005
Page: 30
Company Report #98USA11457
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3404503-8Report Type:Periodic
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11458
PT
Report Source
Product
Role
Decreased Appetite
Vomiting
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
45 MG, DAILY,
ORAL
Date:02/04/99ISR Number: 3404505-1Report Type:Periodic
Age:47 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11462
PT
Report Source
Product
Role
Manufacturer
Route
Dermatitis
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
ORAL
Desoxyn Tablet
(Metamfetamine
Hydrochloride)
SS
ORAL
Duration
DAILY, ORAL
ORAL
Date:02/04/99ISR Number: 3404506-3Report Type:Periodic
Age:44 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11463
PT
Report Source
Product
Role
Glycosuria
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3404509-9Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #98USA11496
Report Source
Product
Role
Manufacturer
Route
Epistaxis
Health
Professional
Ritalin Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
ORAL
20 MG, TID,
ORAL
Date:02/04/99ISR Number: 3404512-9Report Type:Periodic
Age:40 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11497
PT
Report Source
Product
Role
Alopecia
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Zoloft Aerosol
C
Manufacturer
Route
Duration
ORAL
15 MG, BID,
ORAL
Date:02/04/99ISR Number: 3404514-2Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Trichotillomania
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
25 MG, DAILY,
ORAL
18-Aug-2005
Page: 31
Company Report #98USA11506
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3404516-6Report Type:Periodic
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11508
PT
Report Source
Product
Role
Hypervigilance
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10 MG, ONCE,
ORAL
Date:02/04/99ISR Number: 3404519-1Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11515
PT
Report Source
Product
Role
Oedema Peripheral
Health
Professional
Ritalin Tablet 15 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
15 MG, QD,
ORAL
Date:02/04/99ISR Number: 3405177-2Report Type:Periodic
Age:84 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11059
PT
Report Source
Product
Role
Depressed Level Of
Consciousness
Sedation
Health
Professional
Ritalin Tablet 5mg
(Methylphenidate
Hydrochloride)
PS
Remeron Tablet
Persantine Tablet
Lasix Tablet
K-Dur Tablet
Mvi
C
C
C
C
C
Manufacturer
Route
Duration
5 MG, QD,
ORAL
ORAL
Date:02/04/99ISR Number: 3405181-4Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11146
PT
Report Source
Product
Role
Haematuria
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
No Comedication
C
Manufacturer
Route
Duration
ORAL
30 MG, DAILY,
ORAL
Date:02/04/99ISR Number: 3405182-6Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11153
PT
Report Source
Product
Role
Manufacturer
Route
Aggression
Health
Professional
Other
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
ORAL
Claritin Tablet
(Loratadine)
SS
ORAL
Duration
DAILY, ORAL
10 MG, DAILY,
ORAL
18-Aug-2005
Page: 32
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3405185-1Report Type:Periodic
Age:13 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11163
PT
Report Source
Product
Role
Eosinophilia
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10 MG, BID,
ORAL
Date:02/04/99ISR Number: 3405189-9Report Type:Periodic
Age:42 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11168
PT
Report Source
Product
Role
Muscle Rigidity
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Klonopin Tablet
C
Manufacturer
Route
Duration
ORAL
70 MG, DAILY,
ORAL
Date:02/04/99ISR Number: 3405193-0Report Type:Periodic
Age:58 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11172
PT
Report Source
Product
Role
Drug Ineffective
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Xanax Tablet
Ativan Tablet
Lipitor Tablet
Cardizem
C
C
C
C
Manufacturer
Route
Duration
5 MG, TID,
ORAL
ORAL
Date:02/04/99ISR Number: 3405195-4Report Type:Periodic
Age:50 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11239
PT
Report Source
Product
Role
Fatigue
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Xanax Tablet
Activan Tablet
Lipitor
Cardizem
C
C
C
C
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3405197-8Report Type:Periodic
Age:52 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11242
PT
Report Source
Product
Role
Laboratory Test Abnormal
Health
Professional
Ritalin Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
Cardizem Cd Capsule
C
20 MG, QID,
ORAL
18-Aug-2005
Page: 33
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3405199-1Report Type:Periodic
Age:17 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11254
PT
Report Source
Product
Role
Manufacturer
Route
Aggression
Emotional Disorder
Psychotic Disorder
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
ORAL
Adderall Tablet 20
Mg (Adderall)
SS
ORAL
Duration
10 MG, TID,
ORAL
60 MG,DAILY,
ORAL
Date:02/04/99ISR Number: 3405202-9Report Type:Periodic
Age:21 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11257
PT
Report Source
Product
Role
Hallucination
Insomnia
Overdose
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Marijuana (Cannabis)
SS
Wellbutrin Tablet
(Amfebutamone
Hydrochloride)
SS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Psychotic Disorder
RESPIRATORY
(INHALATION)
INHALATION
ORAL
ORAL
Date:02/04/99ISR Number: 3405208-XReport Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11263
PT
Report Source
Product
Dermatitis
Haematuria
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Duration
Role
Manufacturer
Route
Liver Function Test
Hydrochloride)
PS
ORAL
7.5 MG, BID,
Abnormal
ORAL
Date:02/04/99ISR Number: 3405210-8Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11303
PT
Report Source
Product
Role
Insomnia
Tourette'S Disorder
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Prozac
Risperdal
C
C
Manufacturer
Route
Duration
ORAL
15 MG, DAILY,
ORAL
Date:02/04/99ISR Number: 3405211-XReport Type:Periodic
Age:53 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11306
PT
Report Source
Product
Role
Hypoglycaemia
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Insulin Suspension
For Injec
Calcium Tablet
Vitamins
Prozac
C
C
C
C
5 MG, BID,
ORAL
18-Aug-2005
Page: 34
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3405212-1Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11307
PT
Report Source
Product
Role
Liver Function Test
Abnormal
Muscle Spasms
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10 MG, BID,
ORAL
Date:02/04/99ISR Number: 3405213-3Report Type:Periodic
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11342
PT
Report Source
Product
Role
Diplopia
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Laxatives
C
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3405214-5Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11344
PT
Report Source
Product
Role
Dyspnoea
Consumer
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10 MG, TID,
ORAL
Date:02/04/99ISR Number: 3405216-9Report Type:Periodic
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11347
PT
Report Source
Product
Drug Ineffective
Health
Ritalin Tablet 10 Mg
Duration
Role
Manufacturer
Route
Professional
(Methylphenidate
Hydrochloride)
PS
Ritalin-Sr
C
ORAL
10 MG, QD,
ORAL
Date:02/04/99ISR Number: 3405217-0Report Type:Periodic
Age:42 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11357
PT
Report Source
Product
Role
Vision Blurred
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
5 MG, BID,
ORAL
Date:02/04/99ISR Number: 3405218-2Report Type:Periodic
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Hypertension
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
10 MG, BID,
ORAL
18-Aug-2005
Page: 35
Company Report #98USA11358
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3405219-4Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11382
PT
Report Source
Product
Role
Headache
Tic
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
5 MG, BID,
ORAL
Date:02/04/99ISR Number: 3405891-9Report Type:Periodic
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10597
PT
Report Source
Product
Role
Eye Disorder
Muscle Twitching
Consumer
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
7.5 MG, BID,
ORAL
Date:02/04/99ISR Number: 3405896-8Report Type:Periodic
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10601
PT
Report Source
Product
Role
Drug Ineffective
Health
Professional
Ritalin Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
Prevacid Capsule
C
Manufacturer
Route
Duration
20 MG, TID,
ORAL
Date:02/04/99ISR Number: 3405901-9Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Company Report #98USA10602
ORAL
Outcome
Dose
PT
Report Source
Product
Role
Enuresis
Health
Professional
Ritalin Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
20 MG, BID,
ORAL
Date:02/04/99ISR Number: 3405906-8Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Company Report #98USA10603
PT
Report Source
Product
Role
Photosensitivity Reaction
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3405912-3Report Type:Periodic
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Diarrhoea
Headache
Muscle Spasms
Consumer
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
DAILY, ORAL
Nausea
18-Aug-2005
Page: 36
Company Report #98USA10604
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3405918-4Report Type:Periodic
Age:44 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10643
PT
Report Source
Product
Role
Semen Abnormal
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3405925-1Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10644
PT
Report Source
Product
Role
Drug Ineffective
Medication Error
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10MG, BID,
ORAL
Date:02/04/99ISR Number: 3405928-7Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10658
PT
Report Source
Product
Role
Drug Ineffective
Psychomotor Hyperactivity
Health
Professional
Ritalin Tablet 5mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3405932-9Report Type:Periodic
Age:18 YR
Gender:Male
I/FU:I
Outcome
Dose
5 MG, BID,
Company Report #98USA10661
PT
Report Source
Product
Role
Epistaxis
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
ORAL
Caffeine Unknown
(Caffeine)
Ephedrine Unknown
(Ephedrine)
Date:02/04/99ISR Number: 3405936-6Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
SS
SS
Company Report #98USA10679
PT
Report Source
Product
Role
Crying
Irritability
Pollakiuria
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
5 MG BID,
ORAL
Date:02/04/99ISR Number: 3405939-1Report Type:Periodic
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Gynaecomastia
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
60 MG, DAILY,
ORAL
18-Aug-2005
Page: 37
Company Report #98USA10680
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3405941-XReport Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10703
PT
Report Source
Product
Role
Inappropriate Affect
Mood Swings
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3405962-7Report Type:Periodic
Age:55 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10714
PT
Report Source
Product
Role
Headache
Consumer
Ritalin Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
Elavil Tablet
C
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3406028-2Report Type:Periodic
Age:48 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA10769
PT
Report Source
Product
Role
Headache
Nausea
Tremor
Consumer
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3406032-4Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
10MG, BID,
Company Report #98USA10793
PT
Report Source
Product
Role
Drug Ineffective
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
ORAL
Ritalin-Sr Slow
Release Tablet 20 Mg
(Methylphenidate
Hydrochloride)
SS
ORAL
20 MG, DAILY,
ORAL
Date:02/04/99ISR Number: 3406034-8Report Type:Periodic
Age:
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA10803
PT
Report Source
Product
Role
Drug Ineffective
Health
Professional
Ritalin Tablet 5mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
5MG, BID,
ORAL
Date:02/04/99ISR Number: 3406035-XReport Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Headache
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
5MG, BID,
ORAL
18-Aug-2005
Page: 38
Company Report #98USA10815
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3406037-3Report Type:Periodic
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA10879
PT
Report Source
Product
Role
Ecchymosis
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Lithium Tablet
C
Manufacturer
Route
Duration
ORAL
10MG, BID,
ORAL
Date:02/04/99ISR Number: 3406045-2Report Type:Periodic
Age:49 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA10881
PT
Report Source
Product
Role
Muscle Spasms
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3406052-XReport Type:Periodic
Age:47 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10908
PT
Report Source
Product
Role
Hypertension
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Luvox Tablet
Klonopin Tablet
Buspar Tablet
C
C
C
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3406064-6Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #98USA11568
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Consumer
Methylphenidate
Tablet 20 Mg
(Methylphenidate)
PS
Clonidine Tablet
C
ORAL
20 MG, QID,
ORAL
Date:02/04/99ISR Number: 3406066-XReport Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11569
PT
Report Source
Product
Role
Drug Ineffective
Consumer
Methylphenidate
Tablet
(Methylphenidate)
PS
Clonidine Tablet
Trazodone Tablet
C
C
Manufacturer
Route
Duration
ORAL
40 MG, QID,
ORAL
Date:02/04/99ISR Number: 3406071-3Report Type:Periodic
Age:61 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Abdominal Pain
Headache
Vaginal Haemorrhage
Consumer
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
DAILY, ORAL
18-Aug-2005
Page: 39
Company Report #98USA11587
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dexedrine Tablet
Premarin Tablet
Trental Tablet
Lipitor Tablet
Synthroid Tablet
Vitamins Tablet
Date:02/04/99ISR Number: 3406092-0Report Type:Periodic
Age:46 YR
Gender:Female
I/FU:I
Outcome
Dose
C
C
C
C
C
C
Company Report #98USA11594
PT
Report Source
Product
Role
Drug Ineffective
Consumer
Ritalin Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
Zoloft Tablet
C
Manufacturer
Route
Duration
ORAL
20 MG, TID,
ORAL
Date:02/04/99ISR Number: 3406094-4Report Type:Periodic
Age:19 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11595
PT
Report Source
Product
Role
Eosinophilia
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
40 MG, DAILY,
ORAL
Date:02/04/99ISR Number: 3406097-XReport Type:Periodic
Age:36 YR
Gender:Male
I/FU:I
Outcome
Dose
20 MG, TID,
Company Report #98USA11596
PT
Report Source
Product
Role
Anxiety
Headache
Liver Function Test
Health
Professional
Ritalin Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
Abnormal
ORAL
Buspar Tablet
Zyprexa Tablet
Depakote Tablet
Neurontin Tablet
Claritin Tablet
Date:02/04/99ISR Number: 3406105-6Report Type:Periodic
Age:25 YR
Gender:Female
I/FU:I
Outcome
Dose
C
C
C
C
C
Company Report #98USA11597
PT
Report Source
Product
Role
Pregnancy
Consumer
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Klonopin Tablet
C
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3406106-8Report Type:Periodic
Age:16 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Pregnancy
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
DAILY, ORAL
18-Aug-2005
Page: 40
Company Report #98USA11645
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Flagyl Tablet
Zithromax Tablet
Date:02/04/99ISR Number: 3406108-1Report Type:Periodic
Age:20 YR
Gender:Male
I/FU:I
Outcome
Dose
C
C
Company Report #98USA11646
PT
Report Source
Product
Role
Alopecia
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3406109-3Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11694
PT
Report Source
Product
Role
Anorexia
Disturbance In Attention
Insomnia
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10 MG, BID,
Irritability
ORAL
Nervousness
Date:02/04/99ISR Number: 3407533-5Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
10 MG, BID,
ORAL
Company Report #98USA10333
PT
Report Source
Product
Role
Dermatitis
Peripheral Coldness
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
Date:02/04/99ISR Number: 3407534-7Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10334
PT
Report Source
Product
Role
Tic
Consumer
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
5 MG , BID,
ORAL
6
WK
Date:02/04/99ISR Number: 3407535-9Report Type:Periodic
Age:5 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA10366
PT
Report Source
Product
Role
Bronchospasm
Cough
Sneezing
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Vanceril Solution
Aerosol Met
Albuterol Unknown
C
C
Duration
DAILY,
UNKNOWN
18-Aug-2005
Page: 41
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3407536-0Report Type:Periodic
Age:45 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA10367
PT
Report Source
Product
Role
Manufacturer
Route
Arthralgia
Gout
Health
Professional
Ritalin Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
ORAL
Ritalin-Sr Slow
Release Tablet 20 Mg
(Methylphenidate
Hydrochloride)
SS
ORAL
Duration
20 MG , QD,
ORAL
40 MG, DAILY,
ORAL
Date:02/04/99ISR Number: 3407537-2Report Type:Periodic
Age:45 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10383
PT
Report Source
Product
Role
Arthralgia
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
5 MG, BID,
ORAL
3
MON
Date:02/04/99ISR Number: 3407538-4Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Tic
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
25 MG, DAILY,
ORAL
Company Report #98USA10384
ORAL
Date:02/04/99ISR Number: 3407539-6Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10387
PT
Report Source
Product
Role
Tic
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Zoloft Tablet 50 Mg
C
Manufacturer
Route
Duration
ORAL
10 MG, BID,
ORAL
Date:02/04/99ISR Number: 3407540-2Report Type:Periodic
Age:33 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA10404
PT
Report Source
Product
Role
Alopecia
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Prozac Unknown
C
10 MG, TID,
ORAL
18-Aug-2005
Page: 42
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3407541-4Report Type:Periodic
Age:33 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA10419
PT
Report Source
Product
Role
Alopecia
Blood Uric Acid Decreased
Consumer
Ritalin Tablet 10mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10 MG, TID,
ORAL
Date:02/04/99ISR Number: 3407542-6Report Type:Periodic
Age:65 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA10446
PT
Report Source
Product
Role
Convulsion
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10 MG, 5QD,
ORAL
Date:02/04/99ISR Number: 3407543-8Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10465
PT
Report Source
Product
Role
Headache
Health
Professional
Ritalin Tablet 5.0
Mg (Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
5 MG, TID,
ORAL
Date:02/04/99ISR Number: 3407544-XReport Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #98USA10477
Report Source
Product
Role
Manufacturer
Route
Abnormal Behaviour
Anger
Emotional Disorder
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
ORAL
15 MG, TID,
ORAL
Date:02/04/99ISR Number: 3407545-1Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10501
PT
Report Source
Product
Role
Sneezing
Urticaria
Consumer
Health
Professional
Ritalin Tablet 5.0
Mg (Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3407546-3Report Type:Periodic
Age:23 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Drug Ineffective
Consumer
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
DAILY, ORAL
18-Aug-2005
Page: 43
Company Report #98USA10503
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3407547-5Report Type:Periodic
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10516
PT
Report Source
Product
Role
Haematuria
Health
Professional
User Facility
Ritalin Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
20 MG, BID,
ORAL
Date:02/04/99ISR Number: 3407548-7Report Type:Periodic
Age:56 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10530
PT
Report Source
Product
Role
Ejaculation Disorder
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
15 MG, BID,
ORAL
Date:02/04/99ISR Number: 3407549-9Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10531
PT
Report Source
Product
Role
Aggression
Agitation
Depression
Health
Professional
Other
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
10 MG, BID,
Emotional Disorder
ORAL
Manufacturer
Route
Duration
2
DAY
Nervousness
Psychotic Disorder
Suicidal Ideation
Date:02/04/99ISR Number: 3407550-5Report Type:Periodic
Age:18 YR
Gender:Male
I/FU:I
Company Report #98USA10537
ORAL
Outcome
Dose
PT
Report Source
Product
Role
Manufacturer
Route
Abnormal Behaviour
Drug Interaction
Irritability
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
ORAL
Ritalin-Sr Slow
Release Tablet 20 Mg
(Methylphenidate
Hydrochloride)
SS
ORAL
Marijuana Unknown
(Cannabis)
SS
Duration
10 MG, QD,
ORAL
20 MG, DAILY,
ORAL
INHALATION
Date:02/04/99ISR Number: 3407551-7Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10544
PT
Report Source
Product
Role
Alopecia
Health
Professional
Ritalin Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
Prednisone Tablet
Amoxicillin Unknown
C
C
20 MG, QD,
ORAL
18-Aug-2005
Page: 44
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3407553-0Report Type:Periodic
Age:48 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10596
PT
Report Source
Product
Role
Abnormal Behaviour
Dry Skin
Erythema
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
600 MG,
DAILY, ORAL
Date:02/04/99ISR Number: 3407586-4Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10137
PT
Report Source
Product
Role
Raynaud'S Phenomenon
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Tofranil Tablet
C
Manufacturer
Route
Duration
ORAL
10 MG TID
ORAL
Date:02/04/99ISR Number: 3407588-8Report Type:Periodic
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA10138
PT
Report Source
Product
Role
Visual Disturbance
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
5 MG TID ORAL
Date:02/04/99ISR Number: 3407591-8Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10157
PT
Report Source
Product
Anxiety
Consumer
Ritalin Tablet 5mg
Duration
Role
Manufacturer
Route
Chest Pain
(Methylphenidate
Hydrochloride)
PS
ORAL
5 MG BID ORAL
Date:02/04/99ISR Number: 3407594-3Report Type:Periodic
Age:19 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA10181
PT
Report Source
Product
Role
Abdominal Pain
Health
Professional
Ritalin Tablet 10mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10 MG TID
ORAL
Date:02/04/99ISR Number: 3407596-7Report Type:Periodic
Age:54 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Arthralgia
Neck Pain
Health
Professional
Ritalin Tablet
Unknown
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
60 MG DAILY
ORAL
18-Aug-2005
Page: 45
Company Report #98USA10182
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3407599-2Report Type:Periodic
Age:43 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA10183
PT
Report Source
Product
Role
Lethargy
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Prevacid Capsule
C
Manufacturer
Route
Duration
ORAL
DAILY ORAL
Date:02/04/99ISR Number: 3407601-8Report Type:Periodic
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA10225
PT
Report Source
Product
Role
Alopecia
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10 MG TID
ORAL
Date:02/04/99ISR Number: 3407603-1Report Type:Periodic
Age:43 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA10237
PT
Report Source
Product
Role
Manufacturer
Route
Drug Effect Decreased
Drug Interaction
Consumer
Ritalin Tablet 10mg
(Methylphenidate
Hydrochloride)
PS
ORAL
Suprax Tablet
(Cefixime)
SS
ORAL
Nordette Tablet
Pred Forte
C
C
Duration
15 MG TID
ORAL
ORAL
9
DAY
Date:02/04/99ISR Number: 3407606-7Report Type:Periodic
Age:45 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10247
PT
Report Source
Product
Role
Liver Function Test
Abnormal
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY ORAL
Date:02/04/99ISR Number: 3407608-0Report Type:Periodic
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA10254
PT
Report Source
Product
Role
Liver Function Test
Abnormal
Health
Professional
Ritalin Tablet
Unknown
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY ORAL
Date:02/04/99ISR Number: 3407610-9Report Type:Periodic
Age:30 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10257
PT
Report Source
Product
Role
Infertility Male
Health
Professional
Ritalin Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
Antacid
C
20 MG QD ORAL
18-Aug-2005
Page: 46
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3407613-4Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10269
PT
Report Source
Product
Role
Drug Ineffective
Consumer
Ritalin Tablet 10mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10 MG BID
ORAL
Date:02/04/99ISR Number: 3407615-8Report Type:Periodic
Age:32 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA10272
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
ORAL
Ritalin-Sr Slow
Release Tablet 20 Mg
(Methylphenidate
Hydrochloride)
SS
ORAL
Duration
DAILY ORAL
ORAL
Date:02/04/99ISR Number: 3407617-1Report Type:Periodic
Age:22 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10273
PT
Report Source
Product
Role
Alopecia
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Zoloft
C
Manufacturer
Route
Duration
10 MG QD ORAL
Date:02/04/99ISR Number: 3407620-1Report Type:Periodic
Age:53 YR
Gender:Female
I/FU:I
Company Report #98USA10290
ORAL
Outcome
Dose
PT
Report Source
Product
Role
Alopecia
Health
Professional
Ritalin Tablet 5mg
(Methylphenidate
Hydrochloride)
PS
Zoloft
Wellbutrin
C
C
Manufacturer
Route
Duration
ORAL
5 MG PRN ORAL
Date:02/04/99ISR Number: 3407622-5Report Type:Periodic
Age:21 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10292
PT
Report Source
Product
Role
Drug Ineffective
Feeling Jittery
Nausea
Consumer
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10 MG TID
ORAL
Date:02/04/99ISR Number: 3407624-9Report Type:Periodic
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Halitosis
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
20 MG BID
ORAL
18-Aug-2005
Page: 47
Company Report #98USA10293
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3407626-2Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10306
PT
Report Source
Product
Role
Dermatitis
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
5 MG BID ORAL
Date:02/04/99ISR Number: 3407629-8Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10308
PT
Report Source
Product
Role
Dysuria
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
12.5 MG DAILY
ORAL
Date:02/04/99ISR Number: 3407631-6Report Type:Periodic
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10325
PT
Report Source
Product
Role
Headache
Nausea
Consumer
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
15 MG DAILY
ORAL
Date:02/04/99ISR Number: 3407818-2Report Type:Periodic
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #97USA12165
PT
Report Source
Product
Pyrexia
Health
Professional
Ritalin Tablet
Unknown
Duration
Role
Manufacturer
Route
(Methylphenidate
Hydrochloride)
PS
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3407824-8Report Type:Periodic
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #97USA12170
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Discomfort
Health
Professional
Ritalin Tablet 10
(Methylphenidate
Hydrochloride)
PS
ORAL
Ritalin-Sr Slow
Release Tablet 20 Mg
(Methylphenidate
Hydrochoride)
SS
ORAL
Duration
10 MG, QD,
ORAL
20 MG, DAILY,
ORAL
Date:02/04/99ISR Number: 3407826-1Report Type:Periodic
Age:40 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Anxiety
Drug Ineffective
Consumer
Ritalin Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
20 MG, TID,
ORAL
18-Aug-2005
Page: 48
Company Report #97USA12198
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3407829-7Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #97USA12201
PT
Report Source
Product
Role
Abdominal Pain
Health
Professional
Ritalin Tablet 12.5
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
12.5 MG, QD,
ORAL
Date:02/04/99ISR Number: 3407832-7Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Company Report #97USA12298
PT
Report Source
Product
Role
Dizziness
Drug Interaction
Health
Professional
Other
Ritalin Tablet
Unknown
(Methylphenidate
Hydrochloride)
PS
ORAL
Claritin Tablet 10mg
(Loratadine)
SS
ORAL
Manufacturer
Route
Duration
DAILY, ORAL
10 MG DAILY,
ORAL
Date:02/04/99ISR Number: 3407835-2Report Type:Periodic
Age:23 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #97USA12304
PT
Report Source
Product
Role
Depression
Insomnia
Health
Professional
Ritalin Tablet 5.0
Mg (Methylphenidate
Hydrochloride)
PS
Zoloft
C
Manufacturer
Route
Duration
5 MG, QD,
ORAL
ORAL
Date:02/04/99ISR Number: 3407838-8Report Type:Periodic
Age:20 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #97USA12306
PT
Report Source
Product
Role
Hypertension
Health
Professional
Ritalin Tablet
Unknown
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3407842-XReport Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Company Report #97USA12346
PT
Report Source
Product
Role
Diarrhoea
Health
Professional
Ritalin Tablet
Unknown
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3407844-3Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Liver Function Test
Abnormal
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
10 MG, TID,
ORAL
18-Aug-2005
Page: 49
Company Report #97USA12350
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Paxil
Date:02/04/99ISR Number: 3407847-9Report Type:Periodic
Age:19 YR
Gender:Male
I/FU:I
Outcome
Dose
C
Company Report #97USA12364
PT
Report Source
Product
Role
Decreased Appetite
Erectile Dysfunction
Health
Professional
Ritalin Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
20 MG, TID,
ORAL
Date:02/04/99ISR Number: 3407851-0Report Type:Periodic
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #97USA12365
PT
Report Source
Product
Role
Flushing
Peripheral Coldness
Pyrexia
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
5 MG, DAILY,
ORAL
Date:02/04/99ISR Number: 3407854-6Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Company Report #97USA12424
PT
Report Source
Product
Role
Rash Macular
Health
Professional
Ritalin Tablet
Unknown
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
DAILY, ORAL
Date:02/04/99ISR Number: 3407856-XReport Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Company Report #97USA12442
ORAL
Outcome
Dose
PT
Report Source
Product
Role
Salivary Hypersecretion
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
15 MG, QID,
ORAL
Date:02/04/99ISR Number: 3407858-3Report Type:Periodic
Age:6 YR
Gender:
I/FU:I
Outcome
Dose
Company Report #97USA12450
PT
Report Source
Product
Role
Blood Alkaline
Phosphatase Increased
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
35 MG, DAILY,
ORAL
Date:02/04/99ISR Number: 3407861-3Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Chest Pain
Health
Professional
Ritalin Tablet
Unknown
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
DAILY, ORAL
18-Aug-2005
Page: 50
Company Report #98USA10034
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3407864-9Report Type:Periodic
Age:69 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10051
PT
Report Source
Product
Role
Cough
Consumer
Ritalin Tablet
Unknown
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3407867-4Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Company Report #98USA10085
PT
Report Source
Product
Role
Alopecia
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3407870-4Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Company Report #98USA10086
PT
Report Source
Product
Role
Drug Ineffective
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3407873-XReport Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
DAILY, ORAL
Company Report #98USA10117
PT
Report Source
Product
Role
Psychotic Disorder
Consumer
Ritalin Tablet
Unknown
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
30
DAY
ORAL
Date:02/04/99ISR Number: 3407875-3Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10126
PT
Report Source
Product
Role
Leukopenia
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
15 MG, BID,
ORAL
Date:02/04/99ISR Number: 3408045-5Report Type:Periodic
Age:48 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11715
PT
Report Source
Product
Role
Anxiety
Headache
Muscle Rigidity
Consumer
Ritalin Tablet 5mg
(Methylphenidate
Hydrochloride
PS
Premarin
C
5MG, BID,
Muscle Spasms
ORAL
Nausea
18-Aug-2005
Page: 51
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3408052-2Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11716
PT
Report Source
Product
Role
Weight Decreased
Consumer
Ritalin Tablet 10mg
(Methylphenidate)
Hydrochlore)
PS
Manufacturer
Route
Duration
ORAL
10 MG,
BID,ORAL
Date:02/04/99ISR Number: 3408054-6Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11717
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Drug Interaction
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
ORAL
Claritin Tablet
(Loratadine)
SS
ORAL
Duration
DAILY, ORAL
ORAL
Date:02/04/99ISR Number: 3408056-XReport Type:Periodic
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11718
PT
Report Source
Product
Role
Drug Interaction
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride
PS
Claritin Tablet
(Loratadine)
Depakote
SS
C
Manufacturer
Route
Duration
DAILY, ORAL
Date:02/04/99ISR Number: 3408058-3Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Company Report #98USA11719
ORAL
Outcome
Dose
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Drug Interaction
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride
PS
ORAL
Claritin Tablet
(Loratadine)
SS
ORAL
Duration
DAILY, ORAL
ORAL
Date:02/04/99ISR Number: 3408061-3Report Type:Periodic
Age:47 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11726
PT
Report Source
Product
Role
Hypertension
Consumer
Ritalin Tablet
(Methylphenidate
Hydrochloride
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3408063-7Report Type:Periodic
Age:21 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Abdominal Pain
Asthenia
Diarrhoea
Health
Professional
Ritalin Tablet 5mg
(Methylphenidate
Hydrochloride
PS
Manufacturer
Route
Duration
DAILY, ORAL
Nausea
Vomiting
18-Aug-2005
Page: 52
Company Report #98USA11753
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3408068-6Report Type:Periodic
Age:43 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11759
PT
Report Source
Product
Role
Drug Tolerance Increased
Health
Professional
Ritalin Tablet 420mg
(Methylphenidate
Hydrochloride)
PS
Prozac
Flexeril
Vicodin
C
C
C
Manufacturer
Route
Duration
ORAL
DAILY ORAL
Date:02/04/99ISR Number: 3408072-8Report Type:Periodic
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11761
PT
Report Source
Product
Role
Abnormal Behaviour
Drug Ineffective
Consumer
Ritalin Tablet 10mg
(Methylphenidate
Hydrochloride)
PS
Atrohist Syrup
C
Manufacturer
Route
Duration
ORAL
10 MG, QID,
ORAL
Date:02/04/99ISR Number: 3408076-5Report Type:Periodic
Age:55 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11771
PT
Report Source
Product
Role
Vision Blurred
Health
Professional
Ritalin Tablet 5mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
5 MG TID,
ORAL
Date:02/04/99ISR Number: 3408078-9Report Type:Periodic
Age:6 YR
Gender:Female
I/FU:I
Company Report #98USA11773
ORAL
Outcome
Dose
PT
Report Source
Product
Role
Dyskinesia
Insomnia
Health
Professional
Ritalin Tablet 40mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
40 MG, QD,
ORAL
Date:02/04/99ISR Number: 3408080-7Report Type:Periodic
Age:57 YR
Gender:Male
I/FU:F
Outcome
Dose
Company Report #97USA11956
PT
Report Source
Product
Role
Drug Interaction
Drug Tolerance Decreased
Consumer
Ritalin Tablet 15mg
(Methylphenidate
Hydrochloride)
PS
Ativan
C
Manufacturer
Route
Duration
ORAL
15 MG, DAILY,
ORAL
Date:02/04/99ISR Number: 3408083-2Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:F
Outcome
Dose
18-Aug-2005
Page: 53
PT
Report Source
Product
Role
Urinary Incontinence
Health
Professional
Ritalin Tablet 10.0
Mg ( Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
10 MGM BID,
ORAL
Company Report #97USA11990
4
YR
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Ddavp
Date:02/04/99ISR Number: 3408251-XReport Type:Periodic
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
C
Company Report #98USA10910
PT
Report Source
Product
Role
Abnormal Behaviour
Health
Professional
Ritalin Tablet
Unknown
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3408255-7Report Type:Periodic
Age:49 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10920
PT
Report Source
Product
Role
Blood Thyroid Stimulating
Hormone Increased
Lymphadenopathy
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3408261-2Report Type:Periodic
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10922
PT
Report Source
Product
Role
Blood Bilirubin Increased
Jaundice
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Prozac
C
Manufacturer
Route
Duration
5 MG, QD,
ORAL
Date:02/04/99ISR Number: 3408265-XReport Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Company Report #98USA10923
ORAL
Outcome
Dose
PT
Report Source
Product
Role
Amnesia
Aphasia
Consumer
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
5 MG, QD,
ORAL
Date:02/04/99ISR Number: 3408268-5Report Type:Periodic
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10950
PT
Report Source
Product
Role
Tic
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10 MG, BID,
ORAL
Date:02/04/99ISR Number: 3408271-5Report Type:Periodic
Age:72 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Dyspnoea
Insomnia
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
10 MG, QD,
ORAL
18-Aug-2005
Page: 54
Company Report #98USA10953
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Theophylline
Lasix
Acetazolamide
Date:02/04/99ISR Number: 3408299-5Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
C
C
C
Company Report #98USA10960
PT
Report Source
Product
Role
Epistaxis
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10 MG, TID,
ORAL
Date:02/04/99ISR Number: 3408301-0Report Type:Periodic
Age:21 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA10964
PT
Report Source
Product
Role
Nausea
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3408303-4Report Type:Periodic
Age:7 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #98USA11014
PT
Report Source
Product
Role
Hypothyroidism
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Ritalin-Sr Slow
Release
Clonidine Tablet
C
C
Manufacturer
Route
Duration
DAILY, ORAL
ORAL
Date:02/04/99ISR Number: 3408305-8Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #98USA11038
PT
Report Source
Product
Role
Alopecia
Health
Professional
Ritalin Tablet Unk
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3408307-1Report Type:Periodic
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #97USA12046
PT
Report Source
Product
Role
Confusional State
Motor Dysfunction
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Depakote Tablet
Tenex Tablet
C
C
DAILY, ORAL
18-Aug-2005
Page: 55
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3408311-3Report Type:Periodic
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #97USA12048
PT
Report Source
Product
Role
Face Oedema
Urticaria
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
5 MG, BID,
ORAL
3
DAY
Date:02/04/99ISR Number: 3408314-9Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #97USA12054
PT
Report Source
Product
Role
Drug Ineffective
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
5 MG, BID,
ORAL
Date:02/04/99ISR Number: 3408319-8Report Type:Periodic
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Company Report #97USA12077
PT
Report Source
Product
Role
Alopecia
Health
Professional
Ritalin Tablet Ukn
(Methylpenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3408322-8Report Type:Periodic
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Company Report #97USA12078
PT
Report Source
Product
Ecchymosis
Health
Professional
Ritalin Tablet Ukn
(Methylpenidate
Duration
Role
Manufacturer
Route
Hydrochloride)
PS
ORAL
RAILY, ORAL
Date:02/04/99ISR Number: 3408328-9Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
DAILY, ORAL
PT
Report Source
Product
Role
Erythema Multiforme
Health
Professional
Ritalin Tablet
Uknown
(Methylpenidate
Hydrochloride)
PS
5
Route
ORAL
MON
Company Report #97USA12110
PT
Report Source
Product
Role
Anaemia
Health
Professional
Ritalin Tablet Ukn
Own (Methylpenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
DAILY, ORAL
18-Aug-2005
Page: 56
Manufacturer
Duration
Date:02/04/99ISR Number: 3408332-0Report Type:Periodic
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Company Report #97USA12109
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/99ISR Number: 3408335-6Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #97USA12131
PT
Report Source
Product
Role
Erythema Multiforme
Urticaria
Health
Professional
Ritalin Tablet 10 Mg
(Methylpenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10 MG, BID,
ORAL
4
MON
Date:02/04/99ISR Number: 3408340-XReport Type:Periodic
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Company Report #97USA12136
PT
Report Source
Product
Role
Pollakiuria
Health
Professional
Ritalin Tablet
Uknown
(Methylpenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/04/99ISR Number: 3408345-9Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #97USA12164
PT
Report Source
Product
Role
Abdominal Pain
Health
Professional
Ritalin Tablet
Uknown
(Methylpenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/05/99ISR Number: 3199100-6Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #FLUV002980049
PT
Report Source
Product
Alopecia
Drug Interaction
Health
Professional
Luvox Tablets 50 Mg
(Fluvoxamine
Duration
Role
Manufacturer
Route
10 MG ,
Maleate)
PS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
PER
ORAL
15 MG
ORAL ;
PER
1YR
Date:02/10/99ISR Number: 3195467-3Report Type:Expedited (15-DaCompany Report #99USA10109
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
TABLET,
PT
Report Source
Product
Role
Vasculitis
Health
Ritalin-Sr
PS
Wegener'S Granulomatosis
Professional
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:02/12/99ISR Number: 3203031-2Report Type:Expedited (15-DaCompany Report #99USA10109
Age:30 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
20 MG,QD,
PT
Report Source
Product
Role
Manufacturer
Route
Malaise
Health
Ritalin-Sr
PS
ORAL
Vasculitis
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
SS
ORAL
ORAL
Wegener'S Granulomatosis
20 MG, DAILY,
ORAL
18-Aug-2005
Page: 57
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/18/99ISR Number: 3203028-2Report Type:Expedited (15-DaCompany Report #99USA10179
Age:35 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
20 MG, BID,
PT
Report Source
Product
Role
Antinuclear Antibody
Health
Ritalin-Sr
PS
Positive
Professional
Nortriptyline
Capsule
Citrucel Dry Powder
C
C
Manufacturer
Route
Duration
ORAL
ORAL
Asthma
Gastrointestinal Disorder
Medication Error
Mucous Membrane Disorder
Night Sweats
Systemic Lupus
Erythematosus
Date:02/23/99ISR Number: 3204642-0Report Type:Expedited (15-DaCompany Report #MPI-97418(1)
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Aggression
Agitation
Intermittent Explosive
Disorder
Health
Professional
Methylphenidate
Tablets 10 Mg
(Methylphenidate
Hydrochloride 10 Mg)
PS
ORAL
Clonidine
Hydrochloride
(Clonidine
Hydrochloride)
SS
ORAL
Bupropion
(Amfebutamone)
SS
ORAL
55 MG, PO
Memory Impairment
Parent-Child Problem
0.1 MG PO
150 MG PO
Date:02/25/99ISR Number: 3207887-9Report Type:Periodic
Age:16 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
Company Report #9726880
PT
Report Source
Product
Role
Catatonia
Social Problem
Consumer
Zoloft Tablets
Ritalin
PS
SS
Manufacturer
Route
Duration
ORAL
ORAL
Tenex
Risperdal
Date:02/25/99ISR Number: 3209993-1Report Type:Periodic
Age:18 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
50.00MG TOTAL
SS
SS
ORAL
ORAL
Company Report #9828259
PT
Report Source
Product
Role
Amnesia
Consumer
Zoloft Tablets
PS
ORAL
Ritalin
SS
ORAL
Birth Control Pills
SS
ORAL
Synthroid
C
Manufacturer
Route
Confusional State
DAILY ORAL
Coordination Abnormal
60.00MG TOTAL
Insomnia
DAILY ORAL
ORAL
Date:02/25/99ISR Number: 3211473-4Report Type:Periodic
Age:28 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
200.OO MG
Company Report #9808200
PT
Report Source
Product
Role
Manufacturer
Route
Hypoaesthesia
Health
Zoloft Tablets
PS
ORAL
Oedema Peripheral
Professional
Ritalin
SS
ORAL
Duration
TOTAL; DAILY;
ORAL
30.00 MG
TOTAL; TID;
18-Aug-2005
Page: 58
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
ORAL
Vitamin C
Vitamin D
Antioxidants
Date:02/25/99ISR Number: 3211929-4Report Type:Periodic
Age:38 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
100.00 MG
C
C
C
Company Report #9804561
PT
Report Source
Product
Role
Manufacturer
Route
Drug Abuser
Consumer
Zoloft Tablets
PS
ORAL
Drug Interaction
Health
Ritalin
SS
ORAL
Marijuana
SS
Duration
TOTAL:DAILY:O
Professional
RAL
40.00 MG
TOTAL:DAILY:O
RAL
Date:02/25/99ISR Number: 3212214-7Report Type:Periodic
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
50.00 MG
Company Report #9802532
PT
Report Source
Product
Role
Manufacturer
Route
Depersonalisation
Consumer
Zoloft Tablets
PS
ORAL
Hallucination
Health
Thinking Abnormal
Professional
Accutane
SS
ORAL
Ritalin
SS
ORAL
Duration
TOTAL: DAILY:
ORAL
40.00 MG
TOTAL: DAILY
: ORAL
10.00 MG
TOTAL: DAILY:
ORAL
Date:02/25/99ISR Number: 3212730-8Report Type:Periodic
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
150.00 MG
Company Report #9803621
PT
Report Source
Product
Role
Manufacturer
Route
Anorexia
Consumer
Zoloft Tablets
PS
ORAL
Intentional Misuse
Ritalin
SS
ORAL
Libido Decreased
Pollakiuria
Vitamin E
C
Duration
Depression
TOTAL:DAILY:O
Drug Ineffective
RAL
ORAL
Date:02/25/99ISR Number: 3216492-XReport Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
50.00MG TOTAL
Company Report #9803250
PT
Report Source
Product
Role
Manufacturer
Route
Choreoathetosis
Health
Zoloft Tablets
PS
ORAL
Drug Interaction
Professional
Ritalin
SS
ORAL
Dexedrine
SS
ORAL
DAILY ORAL
Tardive Dyskinesia
ORAL
ORAL
Date:02/25/99ISR Number: 3217091-6Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
25 MG TOTAL
PT
Report Source
Product
Role
Drug Interaction
Health
Zoloft Tablets
PS
Ecchymosis
Professional
Manufacturer
Route
Duration
DAILYORAL
18-Aug-2005
Page: 59
Company Report #9812057
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Ritalin
SS
Clonidine
C
ORAL
15 MG TOTAL
TID ORAL
Date:02/26/99ISR Number: 3214260-6Report Type:Periodic
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
150 MG
Company Report #8-98128-002T
PT
Report Source
Product
Role
Chest Pain
Consumer
Effexor
PS
Phentermine
Pondimin
Ritalin
Adderall
Phentermine
Pondimin Oral
Ritalin
SS
SS
SS
C
C
C
C
Manufacturer
Route
Duration
Dyspnoea
ORAL
ORAL
Date:03/01/99ISR Number: 3209268-0Report Type:Expedited (15-DaCompany Report #99NZ-10005
Age:
Gender:
I/FU:I
Outcome
Dose
Death
INTRAVENOUS
PT
Report Source
Product
Role
Haemorrhagic Stroke
Foreign
Health
Professional
Ritalin Unknown
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Duration
DAILY,
Other
INTRAVENOUS
Date:03/01/99ISR Number: 3209324-7Report Type:Expedited (15-DaCompany Report #99USA10226
Age:18 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Drug Interaction
Lethargy
Health
Professional
Ritalin Tablet 15 Mg
(Methylphenidate
Role
Stupor
Hydrochloride)
PS
Depakote Tablet
Klonopin Tablet
Tegretol Tablet
Augmentin Tablet
C
C
C
C
15 MG, QD,
UNKNOWN
Date:03/01/99ISR Number: 3432298-0Report Type:Periodic
Age:8 YR
Gender:Female
I/FU:F
Outcome
Dose
Company Report #MPI-98055
PT
Report Source
Product
Role
Manufacturer
Route
Personality Disorder
Health
Professional
Methylphenidate Hcl
PS
Md Pharmaceutical
Inc
ORAL
Duration
10 MG DAILY,
PO
Date:03/01/99ISR Number: 3432301-8Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
PT
Report Source
Product
Role
Manufacturer
Route
Muscle Twitching
Consumer
Methylphenidate Hcl
PS
Md Pharmaceutical
Inc
ORAL
Duration
10 MG BID, PO
18-Aug-2005
Page: 60
Company Report #MPI-98056
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/01/99ISR Number: 3432308-0Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Company Report #MPI-98179
PT
Report Source
Product
Role
Manufacturer
Route
Asthenia
Drug Ineffective
Health
Professional
Methylphenidate Hcl
PS
Md Pharmaceutical
Inc
ORAL
Duration
15 MG TID, PO
Clonadine
Date:03/01/99ISR Number: 3432314-6Report Type:Periodic
Age:45 YR
Gender:Female
I/FU:F
Outcome
Dose
C
Company Report #MPI-98181
PT
Report Source
Product
Role
Manufacturer
Route
Drug Effect Decreased
Drug Ineffective
Consumer
Methylphenidate Hcl
PS
Md Pharmaceutical
Inc
ORAL
Manufacturer
Route
Duration
10 MG QID, PO
Estrogen (Estrogenic
Substance)
Vasotec (Enalapril
Maleate)
Date:03/01/99ISR Number: 3440908-7Report Type:Periodic
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
C
C
Company Report #98USA10258
PT
Report Source
Product
Role
Hypothyroidism
Health
Professional
Anafranil Capsule 25
Mg (Clomipramine
Hydrochloride)
PS
ORAL
Ritalin Tablet
(Methylphenidrate
Hydrochloride)
SS
ORAL
Duration
25 MG, QD,
ORAL
40 MG, DAILY,
ORAL
Date:03/02/99ISR Number: 3209329-6Report Type:Expedited (15-DaCompany Report #99USA10225
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Intentional Misuse
Medication Error
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Duration
UNK, DAILY,
INTRANASAL
Date:03/03/99ISR Number: 3211815-XReport Type:Expedited (15-DaCompany Report #WAES 99020288
Age:7 YR
Gender:Male
I/FU:F
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 61
11:49 AM
PT
Anorexia
Attention
Deficit/Hyperactivity
Disorder
Blood Cortisol Increased
Conjunctivitis
Cushingoid
Cystitis
Encephalopathy
Haematuria
Hyperreflexia
Hypertension
Labile Blood Pressure
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Nephritis Interstitial
Proteinuria
Pyrexia
Report Source
Product
Role
Pyuria
Health
Crixivan
PS
ORAL
Renal Tubular Acidosis
Professional
Megace
SS
ORAL
Company
Ritalin
SS
ORAL
Representative
Lamivudine
Sulfamethoxazole (+)
Trimethopril
Zidovudine
C
Manufacturer
Route
Duration
PO
PO
PO
C
C
Date:03/05/99ISR Number: 3214371-5Report Type:Expedited (15-DaCompany Report #99USA10246
Age:50 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Ventricular Tachycardia
Health
Professional
Ritalin Tablet 10mg
(Methylphenidate
Hydrochloride)
PS
Tiazac
C
Manufacturer
Route
ORAL
10 MG, TID,
ORAL
1
YR
Date:03/12/99ISR Number: 3218855-5Report Type:Direct
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
20MG AM 10MG
PT
Headache
Company Report #
Report Source
Product
Role
Ritalin
PS
Jaw Disorder
NOON
30#
Muscle Twitching
Date:03/17/99ISR Number: 3222278-2Report Type:Direct
Age:
Gender:Male
I/FU:I
Company Report #
Manufacturer
Route
Outcome
Dose
PT
Report Source
Product
Role
Ritalin
PS
Manufacturer
Route
Duration
Abnormal Behaviour
ORAL
1 5 MG TAB Q
AM AND 1 Q
NOON
Date:03/22/99ISR Number: 3224116-0Report Type:Expedited (15-DaCompany Report #9904511
Age:35 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Required
100.00 MG
Intervention to
TOTAL: DAILY:
Prevent Permanent
ORAL
Impairment/Damage
30.00 MG
PT
Report Source
Product
Role
Manufacturer
Route
Breast Discharge
Health
Zoloft Tablets
PS
ORAL
Breast Haemorrhage
Professional
Ritalin
SS
ORAL
Fatigue
Mastitis
Staphylococcal Infection
TOTAL: TID:
ORAL
Date:03/22/99ISR Number: 3224294-3Report Type:Expedited (15-DaCompany Report #99USA10246
Age:50 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
10 MG, TID
18-Aug-2005
Page: 62
1
YR
11:49 AM
PT
Report Source
Product
Role
Chest Pain
Exercise Test Abnormal
Ventricular Tachycardia
Health
Professional
Ritalin Tablet 10 Mg
(Methyphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/24/99ISR Number: 3319281-0Report Type:Periodic
Age:11 YR
Gender:Female
I/FU:F
Outcome
Dose
Company Report #WAES 98101346
PT
Report Source
Product
Role
Attention
Health
Tab Singulair 5 Mg
PS
Deficit/Hyperactivity
Disorder
Drug Interaction
Professional
Ritalin Unk
SS
Manufacturer
Route
Duration
ORAL
PO
Date:03/30/99ISR Number: 3418515-1Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Company Report #AR-1199
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Other
Methylphenidate Hcl
PS
Danbury Pharmacal
Inc
ORAL
SS
Danbury/Schein
ORAL
Duration
10MG/DAY
(ORAL)
Methylphenidate Hcl
Tablets, 5mg
(Danbury/Schein)
5 MG/DAY
(ORAL)
Date:03/30/99ISR Number: 3418521-7Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
8:00A.M.(ORAL
NOON (ORAL),
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Other
Methylphenidate Hcl
PS
Danbury Pharmacal
Inc
ORAL
Duration
10 MG AT
),10 MG AT
Company Report #AR-1235
7.5 MG AT
Date:03/30/99ISR Number: 3418528-XReport Type:Periodic
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #AR-1236
PT
Report Source
Product
Role
Manufacturer
Route
Drug Effect Decreased
Consumer
Health
Methylphenidate Hcl
PS
Danbury Pharmacal
Inc
ORAL
Duration
3 TABS. 6:00
Professional
A.M. (ORAL);
3 TABS. 10:30
A.M. (ORAL);
3 TABS. 3:00
Vanceril
Vancenase
Claritin
Albuterol
Date:03/30/99ISR Number: 3418535-7Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
C
C
C
C
Company Report #AR-1237
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Other
Methylphenidate Hcl
PS
Danbury Pharmacal
Inc
ORAL
Duration
10 MG IN A.M.
(ORAL)
Methylphenidate Hcl
Tablets, 5 Mg
(Danbury/Schein)
5 MG AT LUNCH
(ORAL)
18-Aug-2005
Page: 63
11:49 AM
SS
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/30/99ISR Number: 3418546-1Report Type:Periodic
Age:48 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #AR -1239
PT
Report Source
Product
Role
Manufacturer
Route
Drug Effect Decreased
Company
Representative
Methylphenidate Hcl
PS
Danbury Pharmacal
Inc
ORAL
Route
Duration
25 MG PO OD
5
YR
Anaprox
Date:03/30/99ISR Number: 3418550-3Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
C
Company Report #AR - 1240
PT
Report Source
Product
Role
Manufacturer
Drug Effect Decreased
Consumer
Health
Methylphenidate Hcl
PS
Danbury Pharmacal
Inc
Methylphenidate
Tabs 10 Mg
SS
Duration
15 MG AM, 10
Professional
MG NOON, 10MG
4PM
Date:03/30/99ISR Number: 3418552-7Report Type:Periodic
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Company Report #AR - 1241
PT
Report Source
Product
Role
Manufacturer
Drug Ineffective
Health
Professional
Methylphenidate Hcl
PS
Danbury Pharmacal
Inc
Role
Manufacturer
Route
Duration
Date:04/05/99ISR Number: 3232860-4Report Type:Expedited (15-DaCompany Report #99D--10259
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Anaemia
Leukocytosis
Foreign
Health
Ritalin Tablet
(Methylphenidate
Route
Pyrexia
Professional
Thrombocythaemia
Other
Hydrochloride)
PS
ORAL
1.5 DF,
DAILY, ORAL
Urinary Tract Infection
Date:04/07/99ISR Number: 3234266-0Report Type:Direct
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #
Report Source
Product
Role
Manufacturer
Ritalin
(Methylphenidate
Hydrochloride)
PS
Danbury Pharmacol,
Inc.
Ritalin
(Methylphenidate
Hydrochloride)
SS
Medeva
Pharmaceuticals
Duration
Medication Error
Date:04/15/99ISR Number: 3240721-XReport Type:Expedited (15-DaCompany Report #98HQ-10217
Age:10 YR
Gender:Male
I/FU:F
Outcome
Death
18-Aug-2005
Page: 64
PT
Arrhythmia
Condition Aggravated
Dizziness
Grand Mal Convulsion
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Psychomotor Hyperactivity
Syncope
Tic
Dose
Report Source
Product
Role
Literature
Health
Professional
Ritalin Unknown
(Methylphenidate
Hydrochloride)
PS
Clonidine Unknown
(Clonidine)
SS
Manufacturer
Route
Manufacturer
Route
Duration
Transient Ischaemic
Attack
DAILY
Date:04/15/99ISR Number: 3240724-5Report Type:Expedited (15-DaCompany Report #96USA13072
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Arrhythmia
Grand Mal Convulsion
Psychomotor Hyperactivity
Literature
Health
Professional
Methylphenidate
Tablet
(Methylphenidate)
PS
ORAL
Clonidine
Trans-Therapeutic
System
SS
ORAL
Duration
20 MG, DAILY
Syncope
, ORAL
Tic
Transient Ischaemic
Attack
ORAL
Date:04/19/99ISR Number: 3242995-8Report Type:Expedited (15-DaCompany Report #96J-10255
Age:18 MON Gender:Female
I/FU:F
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
3 MG DAILY
PT
Report Source
Product
Role
Blood Creatine
Phosphokinase Increased
Cellulitis
Foreign
Literature
Health
Methylphenidate
Tablet
(Methylphenidate)
PS
Face Oedema
Hyperhidrosis
Hypertension
Hypertonia
Leukocytosis
Muscle Rigidity
Neuroleptic Malignant
Professional
Other
Amoxicillin
C
Manufacturer
Route
ORAL
Syndrome
Opisthotonus
Otitis Media
Pseudobulbar Palsy
Pyrexia
Quadriplegia
Tachycardia
Tachypnoea
Date:04/22/99ISR Number: 3244544-7Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
2TABS 8AM 1
PT
Report Source
Product
Role
Ritalin
PS
Duration
Decreased Appetite
Dermatitis
1/2 TABS 12
Headache
NOON & 1 TAB
Nausea
3PM
Nervousness
18-Aug-2005
Page: 65
Company Report #
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/26/99ISR Number: 3245749-1Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PS
PT
Company Report #
Report Source
Product
Role
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
ORAL
Methylphenidate
10MG ORAL
-TWICE DAY
Date:04/27/99ISR Number: 3247542-2Report Type:Expedited (15-DaCompany Report #99USA10443
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Monocyte Count Increased
Platelet Count Decreased
White Blood Cell Count
Health
Professional
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
PS
Duration
ORAL
20 MG, QD,
Decreased
ORAL
Albuterol Aerosol
Multivitamin With M
Tablet
Date:04/28/99ISR Number: 3248421-7Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
3
DAY
PT
C
C
Company Report #
Report Source
Product
Role
Ritalin
PS
Manufacturer
Route
Manufacturer
Route
Duration
Mental Disorder
Paraesthesia
Date:04/30/99ISR Number: 3250846-0Report Type:Expedited (15-DaCompany Report #99NL-10016
Age:26 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Abortion
Foreign
Health
Ritalin Unknown
(Methylphenidate
Duration
Role
Professional
Hydrochloride)
PS
ORAL
30 MG,
Other
DAILY, ORAL
Date:05/17/99ISR Number: 3263693-0Report Type:Expedited (15-DaCompany Report #99USA10510
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Aggression
Pyromania
Health
Professional
Ritalin Tablet
(Methlphenidate
Hydrochloride)
PS
Depakote Tablet
C
Manufacturer
Route
Manufacturer
Route
25 MG, QD,
Date:05/24/99ISR Number: 3269217-6Report Type:Expedited (15-DaCompany Report #99D--10259
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Anaemia
Blood Iron Decreased
Haemoglobin Decreased
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Iron Deficiency
Other
20 MG, DAILY,
ORAL
Leukocytosis
Pyrexia
Thrombocythaemia
Urinary Tract Infection
18-Aug-2005
Page: 66
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/28/99ISR Number: 3272815-7Report Type:Direct
Age:38 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Company Report #
Report Source
Product
Role
Manufacturer
Methylphenidate 5 Mg
Tablets
PS
Danbury / Schein
Thyroid Tablets
C
Route
Duration
Feeling Jittery
Gastrointestinal Disorder
3 TABS 3X/DAY
Date:05/28/99ISR Number: 3274100-6Report Type:Periodic
Age:
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Company Report #98USA10571
PT
Report Source
Product
Role
Manufacturer
Route
Insomnia
Overdose
Psychotic Disorder
Health
Professional
Ritalin-Sr Slow
Release Tablet 20mg
(Methylphenidate
Hydrochloride)
PS
ORAL
Ritalin Tablet 5.0
Mg (Methylphenidate
Hydrochloride)
SS
ORAL
20 MG, QD,
ORAL
5 MG, DAILY,
ORAL
Tavist-D Tablets
Armour Thyroid
Tablet 60mg
Insomnia
Date:06/03/99ISR Number: 3275255-XReport Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
C
C
Company Report #
Report Source
Product
Role
Ritalin 5mg (Generic
Brand)
PS
Duration
Feeling Abnormal
Sedation
1 MONTH
C
1
MON
Manufacturer
Route
Date:06/04/99ISR Number: 3276719-5Report Type:Expedited (15-DaCompany Report #99HQ-10217
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
INTRAVENOUS
PT
Cough
Drug Dependence
Dyspnoea
UNK, DAILY,
Emphysema
Report Source
Product
Role
Foreign
Literature
Health
Ritalin Unknown
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Professional
INTRAVENOUS
Lung Disorder
Lung Transplant
Respiratory Failure
Rhinorrhoea
Septic Embolus
Silicon Granuloma
Date:06/07/99ISR Number: 3277483-6Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Methylphenidate
PS
Duration
Drug Ineffective
25 MG TID
18-Aug-2005
Page: 67
Other
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/07/99ISR Number: 3277798-1Report Type:Expedited (15-DaCompany Report #99USA10649
Age:21 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Bilirubin Increased
Blood Lactate
Dehydrogenase Increased
Consumer
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
20 MG, QD,
Haemolytic Anaemia
ORAL
Jaundice
Splenomegaly
Date:06/10/99ISR Number: 3280427-4Report Type:Expedited (15-DaCompany Report #99USA10656
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Bipolar Disorder
Depressed Level Of
Consciousness
Consumer
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY ORAL
Drug Withdrawal Syndrome
Dysphonia
Hearing Impaired
Libido Increased
Muscle Disorder
Myalgia
Pain
Suicide Attempt
Ulcer Haemorrhage
Date:06/10/99ISR Number: 3281899-1Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #1998-07-0504
PT
Report Source
Product
Role
Manufacturer
Route
Aggression
Drug Interaction
Health
Professional
Claritin
(Loratadine) Tablets
PS
ORAL
Company
Ritalin Tablets
SS
ORAL
Duration
10 MG QD ORAL
UNKNOWN ORAL
Representative
Date:06/11/99ISR Number: 3281234-9Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Allergy
Desensitization
Medication
C
Company Report #
Report Source
Product
Role
Manufacturer
Route
Ritalin 20 Mg Sr
Each Am
PS
ORAL
Ritalin 5 Mg Am,
Noon, Pm
SS
ORAL
Duration
Abnormal Behaviour
20 MG PO EACH
AM
5 MG PO AM,
NOON, PM
Date:06/16/99ISR Number: 3284273-7Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Methylphenidate
PS
Duration
Drug Ineffective
25 MG TID
18-Aug-2005
Page: 68
Company Report #
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/16/99ISR Number: 3285829-8Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
10MG 3AM, 2Q
Company Report #
PT
Report Source
Product
Role
Drug Effect Decreased
Health
Ritalin
PS
Manufacturer
Route
ORAL
Professional
NOON
Date:06/16/99ISR Number: 3285845-6Report Type:Direct
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PO TID
PT
Company Report #
Report Source
Product
Role
Ritalin (Generic)
PS
Manufacturer
Route
Duration
Drug Effect Decreased
Date:06/16/99ISR Number: 3285846-8Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
10MG PO QAM;
PT
ORAL
Company Report #
Report Source
Drug Ineffective
Product
Role
Ritalin
PS
Manufacturer
Route
ORAL
5MG PO TID
Date:06/17/99ISR Number: 3286223-6Report Type:Expedited (15-DaCompany Report #99GB-10262
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Arrhythmia
Cardiac Murmur
Heart Rate Irregular
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Palpitations
Other
10 MG, BID,
ORAL
Manufacturer
Route
Duration
20
MON
ORAL
Date:06/17/99ISR Number: 3286266-2Report Type:Expedited (15-DaCompany Report #A0094748
Age:31 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
SINGLE DOSE
Hospitalization SINGLE DOSE
Initial or Prolonged
Other
PT
Report Source
Product
Role
Aggression
Health
Lamictal Tablet
PS
ORAL
Aspiration
Professional
Cabapentin Capsule
SS
ORAL
Fluoxetine
Hydrochloride
Risperidone
Methylphenidate
Thioridazine
Ethanol
SS
SS
SS
SS
SS
ORAL
ORAL
ORAL
Electrocardiogram Qrs
Complex Prolonged
Intentional Misuse
Lung Infiltration
Suicide Attempt
Tachypnoea
Ventricular Tachycardia
Vomiting
Manufacturer
Route
ORAL
Date:06/18/99ISR Number: 3286401-6Report Type:Expedited (15-DaCompany Report #99USA10510
Age:12 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Aggression
Pyromania
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Depakote Tablet
C
25 MG, QD
18-Aug-2005
Page: 69
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/21/99ISR Number: 3286460-0Report Type:Direct
Age:8 YR
Gender:
I/FU:I
Outcome
Dose
Duration
Other
5MG TID ORAL
PT
Company Report #
Report Source
Decreased Appetite
Product
Role
Ritalin
PS
Manufacturer
Route
ORAL
Erection Increased
Weight Decreased
Date:06/22/99ISR Number: 3288939-4Report Type:Expedited (15-DaCompany Report #1191252A
Age:39 YR
Gender:
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Analgesic Drug Level
Above Therapeutic
Completed Suicide
Literature
Health
Professional
Unknown
Acetaminophen
Product
PS
ORAL
Salicylate
SS
ORAL
Methylphenidate
SS
ORAL
Duration
UNKNOWN DOSE,
Intentional Misuse
PO
UNKNOWN DOSE,
PO
UNKNOWN DOSE,
PO
Date:06/24/99ISR Number: 3290928-0Report Type:Expedited (15-DaCompany Report #208382
Age:29 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Agitation
Anxiety
Ecchymosis
Foreign
Other
Laroxyl
(Amitriptyline
Hydrochloride) 25 Mg
PS
250 MG 1 PER
Fall
1 ONE DOSE
Hallucination
Zoloft (Sertraline
Manufacturer
Route
ORAL
Overdose
Hydrochloride)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride
SS
ORAL
Stilnox (Zolpidem
Tartrate)
SS
ORAL
1.4 GRAM 1
PER 1 ONE
DOSE
600 MG 1 PER
1 ONE DOSE
400 MG 1 PER
1 ONE DOSE
Tranxene
(Clorazepate
Dipotassium)
Vivalan (Viloxazine
Hydrochloride)
Athymil (Mianserin
Hydrochoride)
C
C
C
Date:06/28/99ISR Number: 3292921-0Report Type:Expedited (15-DaCompany Report #99D-10497
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Attention
Deficit/Hyperactivity
Disorder
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Condition Aggravated
Other
UNK, DAILY,
ORAL
56
MON
Syncope
18-Aug-2005
Page: 70
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/28/99ISR Number: 3292935-0Report Type:Expedited (15-DaCompany Report #99F--10541
Age:29 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Agitation
Anxiety
Ecchymosis
Foreign
Health
Professional
Ritaline Tablet
(Methylphenidate
Hydrochloride)
PS
ORAL
Fall
Other
Laroxyl Tablet
(Amitriptyline
Hydrochloride)
SS
ORAL
Tranxene Tablet
(Dipotassium
Clorazepate)
SS
ORAL
Athymil Tablet
(Mianserin
Hydrochloride)
SS
ORAL
Vivalan Tablet
(Viloxazine
Hydrochloride)
SS
ORAL
Stilnox Tablet
(Zolpidem)
SS
ORAL
Zoloft Tablet
(Sertraline
Hydrochloride)
SS
ORAL
600 MG, ONCE,
ORAL
1
DAY
Hallucination
Intentional Misuse
250 MG, ONCE,
ORAL
1
DAY
UNK, UNK,
ORAL
UNK, UNK,
ORAL
UNK, UNK,
ORAL
1
DAY
400 MG, ONCE,
ORAL
1.4 G, ONCE,
ORAL
1
DAY
Date:06/30/99ISR Number: 3295078-5Report Type:Expedited (15-DaCompany Report #99NZ-10075
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abdominal Pain Lower
Conjunctivitis
Convulsion
Foreign
Health
Professional
Ritalin Unknown
(Methylphenidate
Hydrochloride)
PS
Dermatitis
Other
Nitriderm Tts
Trans-Therapeutic-Sy
stem (Glyceryl
Trinitrate)
SS
Clamoxyl Solution
For Injection
(Amoxicillin)
SS
Clamoxyl Tablet
(Amoxicillin)
SS
Gastrografin
Solution
(Gastrografin)
SS
Triflucan Capsule
(Fluconazole)
SS
Manufacturer
Route
ORAL
70 MG, DAILY,
ORAL
TRANSDERMAL
TRANSDERMAL
INTRAVENOUS
Dermatitis Bullous
Diverticulum
Genital Ulceration
Stevens-Johnson Syndrome
10 MG, DAILY,
Syncope
4
DAY
Urinary Tract Infection
Vomiting
3 G, DAILY,
INTRAVENOUS
ORAL
3 G, DAILY,
ORAL
RECTAL
UNK, UNK,
RECTAL
200 MG,
DAILY, ORAL
Amlor Capsule
Insulatard
18-Aug-2005
Page: 71
11:49 AM
C
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Suspension For Inj
Digoxine Tablet
Solupsan Tablet
Lasilix Tablet
Alpress Tablet
Mopral Unknown
C
C
C
C
C
C
Date:06/30/99ISR Number: 3295090-6Report Type:Expedited (15-DaCompany Report #9926807
Age:29 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization 1400.00 MG
Initial or Prolonged
TOTAL:DAILY:O
PT
Report Source
Product
Role
Manufacturer
Route
Agitation
Foreign
Zoloft Tablets
PS
ORAL
Anxiety
Health
Ecchymosis
Professional
Fall
Other
Zolpidem
SS
ORAL
Methylphenidate
SS
ORAL
Amitriptyline
SS
ORAL
Potassium
Clorazepate
Viloxazine
Mianserine
C
C
C
RAL
400.00 MG
Hallucination
TOTAL:DAILY:O
Medication Error
RAL
Overdose
600.00 MG
TOTAL:DAILY:O
RAL
250.00 MG
TOTAL:DAILY:O
RAL
Date:07/01/99ISR Number: 3294960-2Report Type:Expedited (15-DaCompany Report #AR-1238
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Other
Methylphenidate Hcl
Tablets, 5mg
(Danbury/Schein)
PS
Danbury / Schein
ORAL
Risperdal
C
Manufacturer
Route
Duration
4 TABS/DAY
ORAL
Date:07/06/99ISR Number: 3298013-9Report Type:Expedited (15-DaCompany Report #99D--10497
Age:15 YR
Gender:
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
50 MG
PT
Report Source
Product
Role
Attention
Deficit/Hyperactivity
Disorder
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
ORAL
QD
Rebound Effect
ORAL
57
MON
Shock
Syncope
Date:07/07/99ISR Number: 3297512-3Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
5MG 1/2 TAB
PT
Report Source
Product
Role
Methlyphenidate
PS
Duration
Abnormal Behaviour
Aggression
TID
Condition Aggravated
Impulsive Behaviour
18-Aug-2005
Page: 72
Company Report #
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/07/99ISR Number: 3298032-2Report Type:Direct
Age:5.5 YR Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Company Report #
Report Source
Product
Role
Manufacturer
(Ritalin)-Methylin
Malincroft
PS
Malinccott
Manufacturer
Route
Duration
Abnormal Behaviour
Aggression
5MG 1/2 TAB
Impulsive Behaviour
TID
Date:07/12/99ISR Number: 3301507-0Report Type:Expedited (15-DaCompany Report #9714665
Age:57 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Required
5.00 MG
Intervention to
TOTAL:DAILY:O
Prevent Permanent
RAL
Impairment/Damage
15.00 MG
PT
Report Source
Product
Role
Route
Angioplasty
Consumer
Norvasc Tablets
PS
ORAL
Ritalin
SS
ORAL
Dexedrine
SS
ORAL
Ativan
Xanax
Ventolin
Zocor
Fioricet
Tylenol #3
Aspirin
Bethanechol
Benzodiazepine
C
C
C
C
C
C
C
C
C
Anxiety
Condition Aggravated
Drug Ineffective
Drug Interaction
TOTAL:TID:ORA
Gastrointestinal Motility
L
Disorder
15.00 MG
Myalgia
TOTAL:TID:ORA
Pain In Extremity
L
Psychomotor Hyperactivity
Date:07/12/99ISR Number: 3301622-1Report Type:Expedited (15-DaCompany Report #9828259
Age:18 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Required
50.00 MG
Intervention to
TOTAL:DAILY:O
Prevent Permanent
RAL
Impairment/Damage
60.00 MG
PT
Report Source
Product
Role
Amnesia
Consumer
Zoloft Tablets
PS
ORAL
Confusional State
Health
Drug Interaction
Professional
Ritalin
SS
ORAL
Birth Control Pills
SS
ORAL
Synthroid
C
Insomnia
Manufacturer
Route
Medication Error
TOTAL:DAILY:O
Movement Disorder
RAL
Nervous System Disorder
ORAL
Date:07/13/99ISR Number: 3302540-5Report Type:Expedited (15-DaCompany Report #95USA10000
Age:19 YR
Gender:Male
I/FU:F
Outcome
Death
18-Aug-2005
Page: 73
PT
Alcohol Poisoning
Arrhythmia
Blood Creatine
Phosphokinase Mb
Increased
Brain Hypoxia
Cardiac Arrest
Cardiac Disorder
Cardio-Respiratory Arrest
Cardiomyopathy
Circulatory Collapse
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Ejection Fraction
Abnormal
Fall
Report Source
Product
Role
Head Injury
Hypokinesia
Hypotension
Literature
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Duration
DAILY,
Loss Of Consciousness
INTRANASAL
Myocardial Infarction
Myocardial Ischaemia
Overdose
Pyrexia
Tachycardia
Toxicologic Test Abnormal
Date:07/13/99ISR Number: 3357958-1Report Type:Periodic
Age:20 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #M0206-99
PT
Report Source
Product
Role
Drug Interaction
Health
Remeron
PS
ORAL
Dyspnoea
Professional
Ritalin
SS
ORAL
Depakote
Lithium Carbonate
C
C
Duration
14-45 MG/DAY
PO
Tachycardia
2.5-20 MG PO
Date:07/14/99ISR Number: 3303992-7Report Type:Expedited (15-DaCompany Report #A0094748
Age:31 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
SINGLE DOSE
Hospitalization ORAL
Initial or Prolonged
SINGLE DOSE
PT
Report Source
Product
Role
Aggression
Health
Lamictal Tablet
PS
ORAL
Aspiration
Professional
Gabapentin Capsule
SS
ORAL
Electrocardiogram Qrs
Manufacturer
Route
Other
ORAL
Complex Prolonged
Intentional Misuse
Lung Infiltration
Suicide Attempt
Tachypnoea
Fluoxetine
Hydrochloride
(Formulation
Unknown)
SS
ORAL
Ventricular Tachycardia
Vomiting
Risperidone
(Formulation
Unknown)
SS
ORAL
Methylphenidate
(Formulation
Unknown)
SS
ORAL
Thioridazine
(Formulation
Unknown)
SS
ORAL
Ethanol (Formulation
Unknown)
SS
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
Date:07/14/99ISR Number: 3304026-0Report Type:Expedited (15-DaCompany Report #A0094619
Age:31 YR
Gender:Male
I/FU:F
Outcome
Hospitalization Initial or Prolonged
Other
18-Aug-2005
Page: 74
11:49 AM
PT
Aggression
Aspiration
Electrocardiogram Qrs
Complex Prolonged
Intentional Misuse
Lung Infiltration
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Suicide Attempt
Ventricular Tachycardia
Vomiting
Dose
Report Source
Product
Role
Manufacturer
Route
Health
Lamictal Tablet
PS
ORAL
Professional
Gabapentin
SS
ORAL
Fluoxetine
Hydrochloride
Risperidone
Thioridazine
Methylphenidate
Ethanol
SS
SS
SS
SS
SS
Duration
ORAL
SINGLE DOSE/
ORAL
Date:07/19/99ISR Number: 3306831-3Report Type:Expedited (15-DaCompany Report #1191252A
Age:39 YR
Gender:Female
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Completed Suicide
Drug Level Above
Literature
Health
Regular Strength
Tylenol Tablets
PS
ORAL
Therapeutic
Professional
Salicylate
SS
ORAL
Methylphenidate
SS
ORAL
Ibuprofen
SS
ORAL
Duration
10 G, PO
UNKNOWN DOSE,
PO
1.2 G PO
12 G PO
Date:07/26/99ISR Number: 3310951-7Report Type:Expedited (15-DaCompany Report #99D--10621
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
15 MG , QD,
PT
Report Source
Product
Role
Abdominal Pain Upper
Blood Amylase Increased
Lipase Increased
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
Nausea
ORAL
6
Other
WK
Pancreatitis
Pyrexia
Date:07/26/99ISR Number: 3311949-5Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
11,800MG PO
Company Report #CEPH-1538-99-5082
PT
Report Source
Product
Role
Bradycardia
Diarrhoea
Health
Professional
Provigil 200mg
Tablets
PS
Ritalin Tablet
SS
Manufacturer
Route
ORAL
Insomnia
AT ONCE
Nausea
Suicide Attempt
Date:07/27/99ISR Number: 3313038-2Report Type:Periodic
Age:40 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
50.00 MG
Company Report #9903183
PT
Report Source
Product
Role
Attention
Health
Viagra Tablets
PS
Deficit/Hyperactivity
Professional
Ritalin
SS
TOTAL:PRN:ORA
Disorder
L
Drug Interaction
NOT SPECIFIED
Headache
Rhinitis
18-Aug-2005
Page: 75
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/03/99ISR Number: 3317611-7Report Type:Expedited (15-DaCompany Report #MPI-1999-01603 (0)
Age:15 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Conversion Disorder
Crying
Depersonalisation
Depression
Consumer
Methylphenidate
Tablets 5mg
(Methylphenidate
Hydrochloride 5mg)
PS
Methylphenidate
Tablets 10 Mg
(Methylphenidate
Hydrochloride 10 Mg)
SS
Manufacturer
Route
Manufacturer
Route
Duration
SEE IMAGE
Intentional Self-Injury
STARTED
Laceration
3-4 WEEKS AGO
Paranoia
Speech Disorder
SEE IMAGE
Date:08/04/99ISR Number: 3319410-9Report Type:Expedited (15-DaCompany Report #8-97345-009L
Age:38 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
20 MG DAILY
Required
Intervention to
5 MG TWICE
Prevent Permanent
DAILY
Impairment/Damage
PT
Report Source
Product
Role
Arthralgia
Atrioventricular Block
Consumer
Redux
Prozac (Fluoxetine)
PS
SS
Ritalin
(Methylphenidate)
SS
Complete
Cardiac Arrest
Cardiac Pacemaker
Insertion
Chest Pain
Dyspnoea
Ejaculation Disorder
Erectile Dysfunction
Fatigue
Gastrooesophageal Reflux
Disease
Hypertension
Libido Decreased
Mitral Valve Incompetence
Prostatitis
ORAL
Pulmonary Valve
Incompetence
Sinus Bradycardia
Sleep Apnoea Syndrome
Sleep Disorder
Tachycardia
Tricuspid Valve
Incompetence
Date:08/05/99ISR Number: 3321958-8Report Type:Direct
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
ORAL - NO
Company Report #
PT
Report Source
Product
Role
Agitation
Health
Ritalin
PS
Dysphonia
Professional
Cylert
Imipramine
C
C
DOSAGE DATA
Tic
18-Aug-2005
Page: 76
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/11/99ISR Number: 3324016-1Report Type:Expedited (15-DaCompany Report #19990800145
Age:67 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
TOPICAL
PT
Report Source
Product
Role
Foreign
Xylocaine Jell
PS
Other
Gastrogel
Panadol
Ciprofloxacin
Coloxyl With Senna
Ms Contin Tab
Slow-K
Dothiepin
Ritalin Tab
Dexamethasone
Metoclopramide
SS
SS
SS
SS
SS
SS
SS
SS
C
C
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
Confusional State
TOPICAL
Hallucination
Date:08/12/99ISR Number: 3324856-9Report Type:Expedited (15-DaCompany Report #99HQ-10325
Age:22 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Mania
Literature
Health
Professional
Methylphenidate
Unknown
(Methylphenidate)
PS
Venlafaxine Unknown
(Venlafaxine)
SS
15 MG, DAILY
187.5 MG,
DAILY
Date:08/18/99ISR Number: 3328625-5Report Type:Expedited (15-DaCompany Report #J/99/02235/MEL
Age:23 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Required
Intervention to
Prevent Permanent
PT
Report Source
Product
Role
Abdominal Pain
Blood Amylase Increased
Cardiac Arrest
Coma
Electrocardiogram
Foreign
Health
Professional
Melleril
(Thioridazine
Hydrochloride)
Anafranil
(Clomipramine
PS
Impairment/Damage
Abnormal
Hypothermia
Intentional Misuse
Mydriasis
Oedema
Pancreatic Pseudocyst
Pancreatitis Acute
Suicide Attempt
Hydrochloride)
Lexotan (Bromazepam)
Pyrethia
(Promethazine
Hydrochloride)
Vegetamin-A
(Vegetamin A)
Hirnamin
(Levomepromazine)
Isomytal
(Amobarbital)
Halcion (Triazolam)
Ritalin
(Methylphenidate
Hydrochloride)
Date:08/20/99ISR Number: 3330904-2Report Type:Expedited (15-DaCompany Report #99NZ-10075
Age:
Gender:Female
I/FU:F
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 77
11:49 AM
PT
Convulsion
Syncope
Syncope Vasovagal
Report Source
Foreign
Health
Professional
SS
SS
SS
SS
SS
SS
SS
SS
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Other
Dose
Product
Role
Ritalin Unknown
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
70 MG, DAILY,
ORAL
Date:08/24/99ISR Number: 3333417-7Report Type:Expedited (15-DaCompany Report #99D--10724
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Convulsion
Drug Interaction
Drug Level Above
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Therapeutic
Hallucination
Sedation
Other
Tofranil Mite
Sugar-Coated Table
C
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:08/30/99ISR Number: 3337715-2Report Type:Expedited (15-DaCompany Report #1999-08-0877
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Drug Interaction
Electrocardiogram Qt
Health
Professional
Claritin
(Loratadine)
PS
ORAL
Prolonged
Company
Ritalin Tablets
SS
ORAL
Duration
ORAL
ORAL
Representative
Date:08/30/99ISR Number: 3339376-5Report Type:Expedited (15-DaCompany Report #99USA10970
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Hospitalization Initial or Prolonged
Fatigue
Feeling Abnormal
Gait Disturbance
Sedation
Health
Professional
Ritalin-Sr Slow
Release Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
ORAL
Ritalin Tablet 5 Mg
(Methylphenidate
Hydrochloride)
SS
ORAL
20 MG, QD,
Viral Infection
ORAL
5 MG, DAILY,
ORAL
Date:09/01/99ISR Number: 3339334-0Report Type:Expedited (15-DaCompany Report #99F--10782
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Agitation
Clonic Convulsion
Electroencephalogram
Foreign
Health
Professional
Ritaline Tablet
(Methylphenidate
Hydrochloride)
PS
Abnormal
Other
10 MG, DAILY,
ORAL
Epilepsy
18-Aug-2005
Page: 78
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/03/99ISR Number: 3341479-6Report Type:Expedited (15-DaCompany Report #99HQ-10348
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Blood Pressure Systolic
Increased
Bradycardia
Literature
Health
Professional
Methylphenidate
Unknown
(Methylphenidate)
PS
ORAL
Propranolol Unknown
(Propranolol)
SS
ORAL
30 MG, DAILY,
Coma
ORAL
Confusional State
Difficulty In Walking
180 MG,
Hypoglycaemia
DAILY, ORAL
Pupil Fixed
Date:09/03/99ISR Number: 3341481-4Report Type:Expedited (15-DaCompany Report #99HQ-10349
Age:6 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Blood Pressure Increased
Coma
Depressed Level Of
Literature
Health
Professional
Methylphenidate
Unknown
(Methylphenidate)
PS
ORAL
Propranolol Unknown
SS
ORAL
Guanfacine
Hydrochloride
Unknown (Guanfacine
Hydrochloride)
SS
ORAL
20 MG, DAILY,
Consciousness
ORAL
Heart Rate Decreased
240 MG,
Hypoglycaemia
DAILY, ORAL
Hypoventilation
Respiratory Rate
Decreased
1 MG DAILY,
ORAL
Date:09/07/99ISR Number: 3341951-9Report Type:Expedited (15-DaCompany Report #99USA11007
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Drug Abuser
Stupor
Health
Professional
Other
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
NASAL
Ativan Tablet
(Lorazepam)
SS
NASAL
DAILY,
INTRANASAL
INTRANASAL
Date:09/09/99ISR Number: 3343224-7Report Type:Direct
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
15MG BID PO
Company Report #
PT
Report Source
Product
Role
Abnormal Behaviour
Health
Ritalin
PS
Anger
Anorexia Nervosa
Obsessive-Compulsive
Disorder
Professional
Manufacturer
Route
Duration
1
ORAL
YR
Date:09/14/99ISR Number: 3347407-1Report Type:Expedited (15-DaCompany Report #MPI-1999-01847(0)
Age:1 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 79
PT
Report Source
Product
Neuroleptic Malignant
Syndrome
Literature
Health
Professional
Methylphenidate
Tablets
(Unspecified)
(Methylphenidate
Duration
11:49 AM
Role
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hydrochloride)
PS
Date:09/20/99ISR Number: 3352444-7Report Type:Expedited (15-DaCompany Report #99HQ-10373
Age:36 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Completed Suicide
Hypothermia
Intentional Misuse
Literature
Health
Professional
Methylphenidate
Unknown
(Methylphenidate)
PS
Lorazepam
L-Thyroxine
Alprazolam
C
C
C
Manufacturer
Route
Manufacturer
Route
Duration
DAILY
Date:09/20/99ISR Number: 3352445-9Report Type:Expedited (15-DaCompany Report #99HQ-10374
Age:
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Intentional Misuse
Literature
Health
Professional
Methylphenidate
Tablet
(Methylphenidate)
PS
ORAL
Desipramine Tablet
(Desipramine)
SS
ORAL
Duration
DAILY ORAL
ORAL
Date:09/21/99ISR Number: 3353239-0Report Type:Expedited (15-DaCompany Report #8-99222-001A
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization OVERDOSE
Initial or Prolonged
AMOUNT ORAL
Other
Required
Intervention to
OVERDOSE
PT
Drug Abuser
Report Source
Product
Role
Manufacturer
Route
Ativan Tablets
PS
ORAL
Ritalin
(Methylphenidate)
Tablets
SS
ORAL
Stupor
Prevent Permanent
AMOUNT ORAL
Impairment/Damage
Ritalin
Date:09/23/99ISR Number: 3355682-2Report Type:Direct
Age:9 YR
Gender:
I/FU:I
Outcome
Dose
C
Company Report #
PT
Report Source
Product
Role
Malabsorption
Health
Ritalin
PS
Manufacturer
Route
Duration
ORAL
10MG PO TID
Professional
Date:10/05/99ISR Number: 3363618-3Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Company Report #
PT
Report Source
Product
Role
Drug Effect Decreased
Health
Professional
Ritalin
PS
Duration
Date:10/14/99ISR Number: 3372702-XReport Type:Expedited (15-DaCompany Report #99D--10902
Age:35 YR
Gender:Female
I/FU:I
Outcome
Life-Threatening
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 80
11:49 AM
PT
Arrhythmia
Cardio-Respiratory Arrest
Coma
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Coordination Abnormal
Intentional Misuse
Mental Disorder Due To A
Dose
Report Source
Product
Role
Manufacturer
Route
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
ORAL
Other
Alcohol Unknown
(Ethanol)
SS
ORAL
Trevilor Unknown
(Venlafaxine
Hydrochloride)
SS
ORAL
Duration
General Medical Condition
Suicide Attempt
DAILY, ORAL
ORAL
ORAL
Date:10/25/99ISR Number: 3395686-7Report Type:Periodic
Age:48 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #CEPH-1538-99-5141
PT
Report Source
Product
Role
Arthralgia
Joint Stiffness
Consumer
Health
Provigil 200mg
Tablets
PS
Nasopharyngitis
Professional
Ritalin 5mg
SS
Manufacturer
Route
Duration
ORAL
100-200MG PO
ONCE
Pharyngitis
Date:10/27/99ISR Number: 3383045-2Report Type:Expedited (15-DaCompany Report #9944977
Age:1 DY
Gender:Female
I/FU:I
Outcome
Dose
Duration
Congenital Anomaly
ORAL
PT
Report Source
Product
Role
Complications Of Maternal
Foreign
Zithromax Capsules
PS
ORAL
Exposure To Therapeutic
Health
Methylphenidate
SS
ORAL
Drugs
Polydactyly
Pregnancy
Syndactyly
Professional
Other
Cannabis
SS
ORAL
Manufacturer
Route
Date:11/01/99ISR Number: 3386909-9Report Type:Expedited (15-DaCompany Report #99GB-10725
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Congenital Anomaly
TRANSPLACENTAL
PT
Complications Of Maternal
Exposure To Therapeutic
Drugs
TRANSPLACENTA
Congenital Foot
Report Source
Product
Role
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Azithromycin
Dihydrate Unknown
(Azithromycin
Dihydrate)
SS
Cannabis
C
Manufacturer
Route
Route
Other
L
TRANSPLACENTAL
Malformation
Congenital Hand
Malformation
Polydactyly
TRANSPLACENTA
Syndactyly
L
Date:11/03/99ISR Number: 3387766-7Report Type:Direct
Age:13 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Methylphenidite /
Novartis
PS
Novartis
Duration
Abdominal Pain
Diarrhoea
20MG AM & PM,
WEEKLY
18-Aug-2005
Page: 81
Company Report #
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/03/99ISR Number: 3390230-2Report Type:Periodic
Age:32 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
30 MG
Company Report #077-99
PT
Report Source
Product
Role
Aortic Valve Incompetence
Other
Phentermine Hcl
PS
Pondimin
Redux
Ritalin
Zoloft
SS
SS
SS
SS
Manufacturer
Route
Manufacturer
Route
Duration
Chest Pain
Dizziness
Dysphagia
Headache
Nausea
Palpitations
Restlessness
Sedation
Date:11/04/99ISR Number: 3389048-6Report Type:Expedited (15-DaCompany Report #99GB-10745
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Coma
Hypotonia
Vomiting
Foreign
Health
Professional
Ritalin Unknown
(Methylprednisolone
Hydrochloride)
PS
ORAL
20 MG QD PO
Other
Date:11/08/99ISR Number: 3391522-3Report Type:Expedited (15-DaCompany Report #J/99/02235/MEL
Age:23 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Required
UNSPECIFIED
Intervention to
Prevent Permanent
Impairment/Damage
UNSPECIFIED
PT
Report Source
Product
Role
Abdominal Pain
Cardiac Arrest
Depressed Level Of
Foreign
Health
Professional
Melleril
(Thioridazine
Hydrochloride)
PS
Consciousness
Hypothermia
Mydriasis
Anafranil
(Clomipramine
Hydrochloride)
SS
Oedema
Lexotan (Bromazepam)
SS
Overdose
Pyrethia
UNSPECIFIED
Manufacturer
Route
Pancreatic Pseudocyst
Pancreatitis
(Promethazine
Hydrochloride)
SS
Pancreatitis Acute
Pupillary Reflex Impaired
Vegetamin-A
(Vegetamin A)
SS
Respiratory Disorder
Stupor
Hirnamin
(Levomepromazine)
SS
Suicide Attempt
Isomytal
(Amobarbital)
SS
Halcion (Triazolam)
SS
Ritalin
(Methylphenidate
Hydrochloride)
SS
UNSPECIFIED
UNSPECIFIED
UNSPECIFIED
UNSPECIFIED
UNSPECIFIED
UNSPECIFED
Date:11/10/99ISR Number: 3394020-6Report Type:Expedited (15-DaCompany Report #99CH-10068
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
10 MG DAILY,
ORAL
18-Aug-2005
Page: 82
11:49 AM
PT
Report Source
Product
Role
Priapism
Foreign
Health
Professional
Ritalin Unknown
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/12/99ISR Number: 3394739-7Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Metnylphenidate 5mg
Twice A Day
PS
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
Date:11/15/99ISR Number: 3397378-7Report Type:Expedited (15-DaCompany Report #99D--11002
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Glomerulonephritis
Haematuria
Proteinuria
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Duration
ORAL
20 MG, DAILY
Other
Date:11/15/99ISR Number: 3397778-5Report Type:Expedited (15-DaCompany Report #99USA11278
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Henoch-Schonlein Purpura
Petechiae
Health
Professional
Ritalin Tablet 200
Mg (Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
200 MG, BID,
ORAL
Date:11/22/99ISR Number: 3405379-5Report Type:Expedited (15-DaCompany Report #99USA11295
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
B-Cell Type Acute
Leukaemia
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Risperdal Tablet
C
Duration
DAILY
Manufacturer
Route
Cogentin Tablet
Date:11/24/99ISR Number: 3406913-1Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
10MG TID
C
Company Report #
PT
Report Source
Product
Role
Therapeutic Response
Health
Generic Ritalin
PS
Unexpected
Professional
Manufacturer
Route
Manufacturer
Route
Duration
Date:11/29/99ISR Number: 3410334-5Report Type:Expedited (15-DaCompany Report #MPI-1999-02971(0)
Age:36 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
INTRAVENOUS
Report Source
Product
Role
Delusional Disorder,
Persecutory Type
Medication Error
Literature
Health
Professional
Methylphenidate
Tablets 10 Mg
(Methylphenidate
Hydrochloride)
PS
SEE IMAGE FOR
DOSAGE/AND
THERAPY DATES
18-Aug-2005
Page: 83
PT
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/29/99ISR Number: 3410337-0Report Type:Expedited (15-DaCompany Report #MPI-1999-02973(0)
Age:28 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Delusion
Depression
Hallucination
Medication Error
SEE IMAGE FOR
INTRAVENOUS
Report Source
Product
Role
Literature
Health
Professional
Methylphenidate
Tablets 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
DOSAGE /AND
THERAPY DATES
Date:12/02/99ISR Number: 3411898-8Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Ritalin
PS
Duration
Drug Effect Decreased
10MG 1T TAB Q
AM; 20MG SR
1T TAB Q
1015A
Date:12/02/99ISR Number: 3412577-3Report Type:Direct
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #
PT
Report Source
Product
Role
Drug Effect Decreased
Health
Professional
Methyphenidate 20 Mg
Sr 0730
PS
Methylphenidate 5mg
C
Duration
20MG SR
5 MG
Date:12/03/99ISR Number: 3413475-1Report Type:Expedited (15-DaCompany Report #99A--10016
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Choreoathetosis
Foreign
Other
Ritalin Unknown
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:12/08/99ISR Number: 3416579-2Report Type:Expedited (15-DaCompany Report #9949846
Age:13 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
Blood Pressure Increased
Literature
Zoloft Tablets
PS
ORAL
Chest Pain
Health
Dyspnoea
Professional
Methylphenidate
SS
ORAL
Adderall
SS
ORAL
RAL
Dyspnoea Exertional
30.00 MG
Hyperhidrosis
TOTAL:BID:ORA
Nodal Arrhythmia
L
Palpitations
10.00 MG
Paraesthesia
TOTAL:DAILY:O
Tachycardia
RAL
Date:12/09/99ISR Number: 3417864-0Report Type:Expedited (15-DaCompany Report #99CDN10751
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Disability
15 MG BID
1
YR
18-Aug-2005
Page: 84
11:49 AM
PT
Report Source
Product
Role
Compartment Syndrome
Muscle Atrophy
Wheelchair User
Foreign
Consumer
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Ritalin-Sr Slow
Release Tablet 20 Mg
(Methylphenidate
Hydrochloride)
20 MG, DAILY
1
SS
ORAL
YR
Date:12/13/99ISR Number: 3420463-8Report Type:Expedited (15-DaCompany Report #99USA11392
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Constipation
Urinary Retention
Consumer
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
DAILY, ORAL
Date:12/17/99ISR Number: 3425635-4Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #9912251
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Dysgeusia
Health
Professional
Zithromax Pediatric
Oral Suspension
PS
ORAL
Ritalin
SS
ORAL
Flovent
Ativan
C
C
Duration
ORAL
Muscle Twitching
TID: ORAL
Date:12/20/99ISR Number: 3425966-8Report Type:Expedited (15-DaCompany Report #99D--11076
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Arthralgia
Henoch-Schonlein Purpura
Otitis Media
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
10 MG, DAILY,
Other
ORAL
Manufacturer
Route
ORAL
Date:12/21/99ISR Number: 3426768-9Report Type:Expedited (15-DaCompany Report #MPI-1999-03009 (0)
Age:41 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Halo Vision
Headache
Retinal Artery Thrombosis
Visual Acuity Reduced
Health
Professional
Methylphenidate
Tablets 10mg
(Methylphenidate
Hydrochloride 10 Mg)
PS
Ibuprofen
Asa
C
C
Manufacturer
Route
Manufacturer
Route
Duration
10 MG
Date:12/22/99ISR Number: 3428384-1Report Type:Expedited (15-DaCompany Report #99USA11278
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
20 MG BID
ORAL
18-Aug-2005
Page: 85
PT
Report Source
Product
Role
Henoch-Schonlein Purpura
Petechiae
Rash Generalised
Health
Professional
Ritalin-Sr Slow
Release Tablet 20 Mg
(Methyphenidate
Hydrochloride)
PS
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/22/99ISR Number: 3428577-3Report Type:Expedited (15-DaCompany Report #99USA11442
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abdominal Discomfort
Cough
Depression
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Paxil Tablet
C
Manufacturer
Route
Duration
ORAL
7.5 MG BID
Headache
ORAL
Suicidal Ideation
Date:12/22/99ISR Number: 3428581-5Report Type:Expedited (15-DaCompany Report #99HQ-10540
Age:84 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Eye Disorder
Fibrosis
Retinal
Literature
Health
Professional
Methylphenidate
Unknown
(Methylphenidate)
PS
Manufacturer
Route
Duration
ORAL
UNK, DAILY,
Neovascularisation
ORAL
Date:12/22/99ISR Number: 3428591-8Report Type:Expedited (15-DaCompany Report #99AUS10330
Age:37 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Amylase Increased
Pancreatitis Relapsing
Foreign
Health
Professional
Ritalin Tablet
(Methyphenidate
Hydrochloride)
PS
Lithicare
Aropax
Kapanol
Entocort
C
C
C
C
Manufacturer
Route
Duration
10 MG, BID,
Other
ORAL
ORAL
Date:12/23/99ISR Number: 3432580-7Report Type:Expedited (15-DaCompany Report #99HQ-10540
Age:64 YR
Gender:Male
I/FU:F
Outcome
Dose
Disability
PT
Report Source
Product
Role
Drug Abuser
Fibrosis
Literature
Health
Methylphenidate
(Methylphenidate)
PS
Fundoscopy Abnormal
Retinal Ischaemia
Retinal
Neovascularisation
Visual Acuity Reduced
Professional
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:01/20/00ISR Number: 3446728-1Report Type:Expedited (15-DaCompany Report #00USA10062
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
DAILY, ORAL
18-Aug-2005
Page: 86
PT
Report Source
Product
Role
Tachycardia
Other
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/27/00ISR Number: 3447327-8Report Type:Expedited (15-DaCompany Report #00GB-10053
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Retinopathy
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Other
Date:01/27/00ISR Number: 3447328-XReport Type:Expedited (15-DaCompany Report #00GB-10044
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Pulmonary Hypertension
Foreign
Health
Professional
Ritalin Unknown
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Duration
DAILY
Other
Date:02/02/00ISR Number: 3455582-3Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #99USA10011
PT
Report Source
Product
Role
Leukopenia
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydorchloride)
PS
Duration
ORAL
10 MG, TID
ORAL
Date:02/02/00ISR Number: 3455583-5Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #99USA10182
PT
Report Source
Product
Arrhythmia
Ecchymosis
Consumer
Ritalin Tablet 5 Mg
(Methylphenidate
Duration
Role
Manufacturer
Route
Headache
Hydrochloride)
PS
ORAL
5 MG TID,
Weight Decreased
ORAL
Date:02/02/00ISR Number: 3455584-7Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Company Report #99USA10673
PT
Report Source
Product
Role
Manufacturer
Route
Bradycardia
Diarrhoea
Insomnia
Health
Professional
Other
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
ORAL
Modafinil Tablet 200
Mg (Modafinil)
SS
ORAL
ORAL
Nausea
ORAL
Date:02/02/00ISR Number: 3455585-9Report Type:Periodic
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Company Report #99USA10710
PT
Report Source
Product
Role
Erythema Multiforme
Consumer
Ritalin Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
Cynocobalamin
Ampoule
Prilosec
C
C
20 MG, TID,
ORAL
18-Aug-2005
Page: 87
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Celebrex
Prozac
Propulsid
Librax
Effexor
Xanax
Phenergan
Date:02/02/00ISR Number: 3455586-0Report Type:Periodic
Age:7 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
C
C
C
C
C
C
C
Company Report #99USA11070
PT
Report Source
Product
Role
Sinus Arrhythmia
Ventricular Extrasystoles
Health
Professional
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Hydroxyzine
C
Manufacturer
Route
Duration
ORAL
10 MG, QD,
ORAL
Date:02/02/00ISR Number: 3455587-2Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #99USA11131
PT
Report Source
Product
Role
Hallucination, Visual
Psychotic Disorder
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Prozac
Depakote
Tofranil
C
C
C
Manufacturer
Route
Duration
ORAL
50 MG, QD,
ORAL
Date:02/02/00ISR Number: 3455588-4Report Type:Periodic
Age:54 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #99USA11147
Report Source
Product
Role
Manufacturer
Route
Hospitalization Initial or Prolonged
Grand Mal Convulsion
Consumer
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Claritin
C
ORAL
17.5 MG, QD,
ORAL
9
YR
Date:02/07/00ISR Number: 3453563-7Report Type:Expedited (15-DaCompany Report #99GB-10716
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
40 MG, FAILY,
PT
Report Source
Product
Role
Blood Alkaline
Phosphatase Increased
Blood Bilirubin Increased
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
Jaundice
ORAL
Date:02/10/00ISR Number: 3456366-2Report Type:Expedited (15-DaCompany Report #00USA10140
Age:55 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
60 MG, QD, PO
18-Aug-2005
Page: 88
PT
Report Source
Product
Role
Pericarditis
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Ambien
Prinivil
C
C
Date:02/10/00ISR Number: 3456407-2Report Type:Expedited (15-DaCompany Report #00GB-10044
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Pulmonary Hypertension
Foreign
Health
Professional
Ritalin
Tablet(Methylphenida
te Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
40 MG, DAILY,
Other
ORAL
Date:02/11/00ISR Number: 3456996-8Report Type:Expedited (15-DaCompany Report #99D--11024
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Hypoglycaemia
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
10 MG, BID,
Other
ORAL
Date:02/22/00ISR Number: 3460653-1Report Type:Expedited (15-DaCompany Report #99CDN10751
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Compartment Syndrome
Muscle Atrophy
Post Procedural
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Complication
Other
15 MG, BID
ORAL
1
YR
Wheelchair User
Ritalin-Sr Slow
Release Tablet 20 Mg
(Methylphenidate
Manufacturer
Route
ORAL
Hydrochloride)
SS
ORAL
20 MG, DAILY,
ORAL
1
YR
Date:02/22/00ISR Number: 3460768-8Report Type:Expedited (15-DaCompany Report #99D--11024
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Blood Glucose Decreased
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
10 MG, BID,
Other
ORAL
Date:02/23/00ISR Number: 3461462-XReport Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 89
PT
Company Report #
Report Source
Product
Role
Ritalin Generic
PS
Duration
Drug Ineffective
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/23/00ISR Number: 3461727-1Report Type:Expedited (15-DaCompany Report #MPI-1999-03009 (1)
Age:41 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Halo Vision
Headache
Retinal Artery Thrombosis
Visual Acuity Reduced
Health
Professional
Methyphenidate
Tablets 10mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Duration
10 MG,
UNKNOWN, UNK
Ibuprofen
(Ibuprofen)
Asa (Acetylsalicylic
Acid)
C
C
Date:02/23/00ISR Number: 3461824-0Report Type:Expedited (15-DaCompany Report #MPI-2000-00696 (0)
Age:64 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abnormal Behaviour
Alcoholic
Anxiety
Delusional Disorder,
Persecutory Type
Literature
Health
Professional
Methlphenidate
Tablets
(Unspecified)(Methyl
phenidate
Hydrochloride)
PS
Protriptyline(Protri
ptyline)
Alcohol (Ethanol)
C
C
UP TO 200 MG
Depression
PER DAY/ FIVE
Disturbance In Attention
YRS PRIOR TO
Drug Abuser
ADMISSION
Feelings Of Worthlessness
Hallucination, Auditory
Insomnia
Loose Associations
Medication Error
Persecutory Delusion
Suicidal Ideation
Tangentiality
Date:02/23/00ISR Number: 3462399-2Report Type:Periodic
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
50.00 MG
Company Report #9905148
PT
Report Source
Product
Role
Laboratory Test Abnormal
Health
Zoloft Tablets
PS
Personality Disorder
Professional
Ritalin
SS
Manufacturer
Route
Duration
ORAL
TOTAL: DAILY:
ORAL
Date:02/23/00ISR Number: 3467364-7Report Type:Periodic
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
100.00 MG
Company Report #9911172
PT
Report Source
Product
Role
Manufacturer
Route
Alopecia
Health
Zoloft Tablets
PS
ORAL
Ritalin
SS
ORAL
Duration
Professional
TOTAL:DAILY:O
RAL
ORAL
18-Aug-2005
Page: 90
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/25/00ISR Number: 3463980-7Report Type:Expedited (15-DaCompany Report #00CDN10125
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
DAILY, ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Abnormal Behaviour
Foreign
Ritalin
PS
ORAL
Aggression
Consumer
Ritalin-Sr
SS
ORAL
Amnesia
Bipolar I Disorder
Psychotic Disorder
Suicidal Ideation
Other
Luvox
Risperdal
C
C
Duration
ORAL
Date:02/25/00ISR Number: 3464240-0Report Type:Expedited (15-DaCompany Report #99GB-10262
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Arrhythmia
Cardiac Murmur
Heart Rate Increased
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Palpitations
Other
Manufacturer
Route
Duration
ORAL
10 MG, BID,
ORAL
20
MON
Date:02/28/00ISR Number: 3464430-7Report Type:Expedited (15-DaCompany Report #00HQ-10097
Age:37 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Disability
INTRAVENOUS
DAILY,
PT
Report Source
Product
Role
Lung Transplant
Pneumoconiosis
Progressive Massive
Foreign
Literature
Health
Ritalin Unknown
(Methylphenidate
Hydrochloride)
PS
Fibrosis
Professional
Respiratory Depression
Other
INTRAVENOUS
Date:03/01/00ISR Number: 3466997-1Report Type:Expedited (15-DaCompany Report #00USA10248
Age:35 YR
Gender:Male
I/FU:I
Manufacturer
Route
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Catatonia
Confusional State
Insomnia
Consumer
Ritalin
(Methylphenidate
Hydrochloride)
PS
ORAL
Valium
SS
ORAL
Duration
20 MG, QD,
Logorrhoea
ORAL
Neurosis
ORAL
5
YR
Oral Intake Reduced
Psychotic Disorder
Date:03/08/00ISR Number: 3472172-7Report Type:Expedited (15-DaCompany Report #00CDN10161
Age:
Gender:
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Drug Abuser
Loss Of Consciousness
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Methadon Tablet
C
DAILY
INTRANASAL
18-Aug-2005
Page: 91
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/08/00ISR Number: 3472177-6Report Type:Expedited (15-DaCompany Report #00USA10278
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hypoaesthesia
Syncope
Consumer
Ritalin Tablet 10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10 MG, TID,
ORAL
2
YR
Date:03/10/00ISR Number: 3474517-0Report Type:Expedited (15-DaCompany Report #A007267
Age:18 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Required
5.00 MG
Intervention to
TOTAL; DAILY;
Prevent Permanent
ORAL
Impairment/Damage
PT
Report Source
Product
Role
Bone Marrow Depression
Drug Interaction
Infection In An
Health
Professional
Company
Glucotrol Xl
Extended Release
Tablets
PS
Immunocompromised Host
Representative
Wellbutin
Ritalin
SS
SS
Manufacturer
Route
ORAL
Leukopenia
Varicella
Vomiting
Date:03/13/00ISR Number: 3473931-7Report Type:Expedited (15-DaCompany Report #99USA11278
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
20 MG, BID,
ORAL
PT
Report Source
Product
Role
Henoch-Schonlein Purpura
Petechiae
Health
Professional
Ritalin-Sr Slow
Release Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
Date:03/14/00ISR Number: 3544072-5Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #14375-00M/1272
PT
Report Source
Product
Role
Manufacturer
Route
Hair Disorder
Consumer
Methylphenidate Hcl
PS
Mallinckrodt Inc
ORAL
Manufacturer
Route
Duration
ORAL
Date:03/16/00ISR Number: 3476257-0Report Type:Direct
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #
PT
Report Source
Product
Role
Abnormal Behaviour
Aggression
Health
Professional
Ritalin Sr 20 Mg
Generic
PS
Duration
ORAL
1 PO QD PO
Date:03/17/00ISR Number: 3476455-6Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #
Report Source
Product
Role
Methylphenidate 10mg
Morning & Noon
PS
Methylphenidate
4pm
SS
Duration
Abnormal Behaviour
Aggression
10MG MORNING
& NOON
4MG 4PM
18-Aug-2005
Page: 92
11:49 AM
5mg
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/20/00ISR Number: 3477601-0Report Type:Expedited (15-DaCompany Report #00D--10326
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Headache
Speech Disorder
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
1 DF, TID,
Other
ORAL
Date:03/21/00ISR Number: 3477728-3Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
ORAL
Report Source
Abdominal Pain Upper
Blood Creatine
Phosphokinase Increased
Confusional State
Dyskinesia
Loss Of Consciousness
Neuroleptic Malignant
Syndrome
Pallor
Refusal Of Treatment By
Patient
Respiratory Rate
Increased
Speech Disorder
Urinary Incontinence
Weight Gain Poor
Date:03/23/00ISR Number: 3479000-4Report Type:Direct
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
10 MG 2X DAY
Company Report #
PT
Drug Ineffective
Product
Role
Clozapine
Trifluperazine
Ritalin
Lopid (Gemfibrozol)
Docusate Sodium
Metamucil
Multivitamin
PS
SS
SS
C
C
C
C
Manufacturer
Route
Company Report #
Report Source
Product
Role
Manufacturer
Route
Ritalin 10 Mg Schein
PS
Schein
ORAL
Date:03/24/00ISR Number: 3480099-XReport Type:Expedited (15-DaCompany Report #A0109179A
Age:42 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Required
Intervention to
Prevent Permanent
Impairment/Damage
PT
Report Source
Product
Role
Manufacturer
Route
Chest Pain
Drug Interaction
Health
Professional
Company
Representative
Bupropion
Hydrochloride
Tablet-Controlled
Release (Bupropion
Hydrochloride)
PS
ORAL
Pemoline Unspecified
Tablet (Pemoline)
SS
ORAL
Methylphenidate Hc1
Tablet
SS
ORAL
100
MG/VARIABLE
DOSE/ORAL
ORAL
5 MG TWICE
PER DAY ORAL
18-Aug-2005
Page: 93
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/27/00ISR Number: 3480286-0Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
10 MG DAILY
PT
Company Report #
Report Source
Product
Role
Methylphenidate
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
Abnormal Behaviour
Dermatitis Exfoliative
Eye Movement Disorder
Hallucination
Hallucination, Auditory
Nightmare
Paraesthesia
Paranoia
Phobia
Pruritus
Rash Erythematous
Strabismus
Tic
Date:03/28/00ISR Number: 3480945-XReport Type:Expedited (15-DaCompany Report #00GB-10156
Age:17 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abortion Spontaneous
Haemorrhage
Pain
Foreign
Health
Professional
Ritalin Unknown
(Methylphenidate
Hydrochloride)
PS
Duration
90 MG, DAILY
Other
Date:03/30/00ISR Number: 3482408-4Report Type:Expedited (15-DaCompany Report #00USA10364
Age:47 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hepatic Neoplasm
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Duration
60 MG, DAILY,
ORAL
Climara
ORAL
Trans-Therapeutic
Date:04/04/00ISR Number: 3483595-4Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
HALF TAB TID
Other
ORAL
PT
C
Company Report #
Report Source
Crying
Neurological Symptom
Product
Role
Manufacturer
Route
Methylphenidate 10
Mg Schein
PS
Schein
ORAL
Methylphenidate 5 Mg
Schein
SS
Schein
ORAL
Product
Role
Manufacturer
Route
Ritalin (Generic)
PS
Torticollis
Trismus
Vision Blurred
HALF TAB TID
ORAL
Date:04/17/00ISR Number: 3488913-9Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Duration
Drug Effect Decreased
18-Aug-2005
Page: 94
Company Report #
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/18/00ISR Number: 3489120-6Report Type:Direct
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Company Report #
Report Source
Product
Role
Ritalin
(Methylphenidate)
PS
Manufacturer
Route
Duration
Coronary Artery Disease
20 MG TID;
CONTINUOUSLY
SINCE AGE OF
FOUR
Date:04/18/00ISR Number: 3558459-8Report Type:Periodic
Age:30 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #US002553
PT
Report Source
Product
Role
Manufacturer
Route
Dizziness
Health
Provigil
PS
Cephalon Inc
ORAL
Ritalin
SS
Ephedrine
Caffeine
Wellbutrin Sr
SS
SS
C
Manufacturer
Route
Duration
200 MG QAM
Professional
ORAL
10 MG BID
Date:04/20/00ISR Number: 3490634-3Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Ritalin Generic
PS
Duration
Drug Ineffective
Date:04/24/00ISR Number: 3491839-8Report Type:Expedited (15-DaCompany Report #00CDN10247
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Cold Exposure Injury
Foreign
Health
Professional
Other
Ritalin-Sr Slow
Release Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:04/24/00ISR Number: 3491848-9Report Type:Expedited (15-DaCompany Report #00GB-10044
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Malaise
Pulmonary Hypertension
Foreign
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
40 MGF,
Other
DAILY, ORAL
Date:04/24/00ISR Number: 3491856-8Report Type:Expedited (15-DaCompany Report #00HQ-10193
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
DAILY
18-Aug-2005
Page: 95
PT
Report Source
Product
Role
Coronary Artery Disease
Myocardial Infarction
Literature
Other
Ritalin
(Methylphenidate
Hydrochloride)
PS
Duration
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/28/00ISR Number: 3494278-9Report Type:Expedited (15-DaCompany Report #00HQ-10193
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Coronary Artery Disease
Myocardial Infarction
Literature
Other
Ritalin Unknown
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Duration
DAILY
Date:05/01/00ISR Number: 3495529-7Report Type:Expedited (15-DaCompany Report #00USA10444
Age:76 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Blister
Dermatitis
Pemphigoid
Health
Professional
Ritalin Tablet
(Methylphenidate
Hydrocloride)
PS
Steroids Nos Tablet
C
ORAL
40 MG, DAILY,
ORAL
Date:05/01/00ISR Number: 3495530-3Report Type:Expedited (15-DaCompany Report #00USA10248
Age:35 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Catatonia
Confusional State
Eating Disorder
Consumer
Ritalin Tablet 20 Mg
(Methylphenidate
Hydrochloride)
PS
ORAL
Valium Tablet 40 Mg
(Diazepam)
SS
ORAL
Duration
20 MG, QD, PO
Insomnia
Neurosis
ORAL
5
YR
Psychotic Disorder
Speech Disorder
Date:05/12/00ISR Number: 3499710-2Report Type:Expedited (15-DaCompany Report #00D--10581
Age:3 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Visual Acuity Reduced
Foreign
Consumer
Other
Ritalin Tablet
(Methylphenidate
Hydrochloride)
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
DAILY , ORAL
Date:05/15/00ISR Number: 3500493-8Report Type:Expedited (15-DaCompany Report #00GB-10290
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
5 MG, BID,
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Anorexia
Foreign
Health
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Circulatory Collapse
Professional
Nausea
Pallor
Other
ORAL
Date:05/15/00ISR Number: 3501204-2Report Type:Expedited (15-DaCompany Report #00P-163-0089665-00(0)
Age:42 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Required
Intervention to
Prevent Permanent
PER ORAL
Impairment/Damage
18-Aug-2005
Page: 96
11:49 AM
PT
Report Source
Product
Role
Manufacturer
Route
Chest Pain
Drug Interaction
Health
Professional
Cylert
PS
Abbott Laboratories
Pharmaceutical
Products Div
ORAL
Amfebutamone
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hydrochloride
(Amfebutamone
Hydrochloride)
SS
ORAL
Methylphenidate
Hydrochloride
(Methylphenidate
Hydrochloride)
SS
ORAL
400 MG, 1 IN
1 D, PER ORAL
5 MG, 2 IN 1
D, PER ORAL
Date:05/18/00ISR Number: 3501382-5Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Company Report #USP 081278
Report Source
Medication Error
Date:05/18/00ISR Number: 3501383-7Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Other
Product
Role
Manufacturer
Ritalin
(Methlylphenidate)
Methlylphenidate
PS
SS
Novartis
Product
Role
Manufacturer
Ritalin
(Methlylphenidate)
Methlylphenidate
PS
SS
Novartis
Malllunkrodt
Route
Duration
PT
Company Report #USP 081277
Report Source
Route
Duration
Medication Error
Date:05/18/00ISR Number: 3501826-9Report Type:Expedited (15-DaCompany Report #00D--10618
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Disability
INTRAVENOUS
PT
Report Source
Product
Role
Manufacturer
Hearing Impaired
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
Duration
DAILY,
Professional
INTRAVENOUS
Route
Other
Date:05/19/00ISR Number: 3503435-4Report Type:Expedited (15-DaCompany Report #20000500303
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Retinal Artery Thrombosis
Foreign
Health
Professional
Toprol-Xl
Ritalin
PS
SS
Astrazeneca Lp
Route
Duration
Date:05/22/00ISR Number: 3502832-0Report Type:Expedited (15-DaCompany Report #00USA10364
Age:47 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Benign Hepatic Neoplasm
Health
Professional
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
60 MG, DAILY,
ORAL
Climara
Trans-Therapeutic
18-Aug-2005
Page: 97
11:49 AM
C
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/22/00ISR Number: 3503423-8Report Type:Expedited (15-DaCompany Report #00D--10627
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Aphasia
Cerebral Infarction
Foreign
Health
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Hemiplegia
Professional
Other
Route
Duration
DAILY, ORAL
Date:05/30/00ISR Number: 3505737-4Report Type:Expedited (15-DaCompany Report #00N--10021
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Blood Cholesterol
Increased
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
Hypoproteinaemia
Nephrotic Syndrome
Professional
Other
Duration
DAILY
Date:06/02/00ISR Number: 3507662-1Report Type:Expedited (15-DaCompany Report #00D--10627
Age:12 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
1 DF. QD.
Other
ORAL
4
MON
PT
Report Source
Product
Role
Manufacturer
Route
Aphasia
Cerebral Infarction
Foreign
Health
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Cerebral Ischaemia
Professional
Hemiplegia
Other
Route
Date:06/05/00ISR Number: 3508414-9Report Type:Expedited (15-DaCompany Report #00GB-10290
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization -
PT
Report Source
Product
Role
Manufacturer
Abdominal Pain
Foreign
Ritalin
PS
Novartis
Initial or Prolonged
Anorexia
5 MG, BID,
Other
Circulatory Collapse
ORAL
25
DAY
Gait Disturbance
Nausea
Pallor
Parkinson'S Disease
Weight Decreased
Health
Pharmaceuticals Corp
ORAL
Professional
Other
Date:06/05/00ISR Number: 3509918-5Report Type:Expedited (15-DaCompany Report #00CDN10247
Age:17 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Death
Foreign
Health
Ritalin-Sr
PS
Novartis
Pharmaceuticals Corp
ORAL
Manufacturer
Route
Duration
40 MG, DAILY,
Professional
ORAL
2
YR
Other
Date:06/06/00ISR Number: 3508822-6Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Required
20MG TID PO
5
YR
Intervention to
Prevent Permanent
Impairment/Damage
18-Aug-2005
Page: 98
11:49 AM
Risperdal Tablet
C
Company Report #
PT
Report Source
Product
Role
Blood Creatine
Health
Ritalin 20 Mg Tid
PS
Phosphokinase Increased
Liver Function Test
Abnormal
Professional
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/07/00ISR Number: 3509562-XReport Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
5MG 3X DAY
(2X DAY)
PT
Company Report #
Report Source
Product
Role
Ritalin
PS
Manufacturer
Route
Duration
Tic
3
YR
Date:06/08/00ISR Number: 3510563-6Report Type:Expedited (15-DaCompany Report #A007267
Age:18 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization 10.00 MG
Initial or Prolonged
TOTAL; DAILY;
Required
ORAL
Intervention to
200.00 MG
Prevent Permanent
TOTAL; BID
Impairment/Damage
100.00 MG
PT
Report Source
Product
Role
Manufacturer
Route
Bone Marrow Depression
Health
Glucotrol Xl
PS
Pfizer Inc
ORAL
Diabetes Mellitus
Professional
Wellbutrin
SS
Ritalin
SS
Inadequate Control
Drug Interaction
Fatigue
Herpes Zoster
Leukopenia
TOTAL; QID
Urine Glucose False
Positive
Vomiting
Date:06/08/00ISR Number: 3510757-XReport Type:Expedited (15-DaCompany Report #97GB-10373
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Haemorrhage
Spinal Disorder
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
DAILY, ORAL
Professional
Other
Date:06/09/00ISR Number: 3511614-5Report Type:Expedited (15-DaCompany Report #00ZA-10015
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
10 MG DAILY
PT
Report Source
Product
Role
Manufacturer
Coma
Fatigue
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
Route
Professional
Other
Date:06/12/00ISR Number: 3512311-2Report Type:Expedited (15-DaCompany Report #MPI-2000-04548(0)
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Blood Ph Decreased
Decreased Appetite
Literature
Health
Methylphenidate Hcl
PS
Md Pharmaceutical
Inc
Grand Mal Convulsion
Hyperphagia
Professional
Sertraline
(Sertraline)
SS
Sertraline
(Sertraline)
SS
Route
Duration
80 MG, DAY
25 MG,
50 MG
7
1
DAY
WK
Date:06/15/00ISR Number: 3513628-8Report Type:Direct
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Manufacturer
Methylphenidate
PS
Medeva/Danbury
Pharmacal
Duration
Medication Error
18-Aug-2005
Page: 99
Company Report #USP 53123
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Chlorpheniramine
SS
Goldline
Date:06/19/00ISR Number: 3515543-2Report Type:Expedited (15-DaCompany Report #MPI-2000-04567 (0)
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
Required
AGE 5- AGE 8
Intervention to
Prevent Permanent
Impairment/Damage
PT
Report Source
Product
Role
Manufacturer
Abnormal Behaviour
Aggression
Literature
Health
Methylphenidate Hcl
PS
Md Pharmaceutical
Inc
Anxiety
Condition Aggravated
Depression
Disturbance In Attention
Drug Withdrawal Syndrome
Irritability
Paranoia
Psychomotor Hyperactivity
Psychotic Disorder
Relationship Breakdown
Suicidal Ideation
Professional
Route
Date:06/21/00ISR Number: 3517289-3Report Type:Expedited (15-DaCompany Report #00ZA-10015
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Manufacturer
Route
Circulatory Collapse
Coma
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Diarrhoea
Professional
Fatigue
Sedation
Vomiting
Other
Manufacturer
Route
10 MG, BID;
ORAL
Date:06/22/00ISR Number: 3517799-9Report Type:Periodic
Age:48 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #14550-00M/1514
Report Source
Product
Role
Other
10 MG BID TO
Drug Ineffective
Health
Methylphenidate Hcl
PS
Ritalin
C
Mallinckrodt Inc
ORAL
Professional
QI ORAL
Date:06/22/00ISR Number: 3517801-4Report Type:Periodic
Age:20 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
10 MG BID
Company Report #14549-00M/1513
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Health
Methylphenidate Hcl
PS
Mallinckrodt Inc
ORAL
Duration
Professional
ORAL
Date:06/22/00ISR Number: 3517802-6Report Type:Periodic
Age:7.5 YR Gender:Male
I/FU:I
Outcome
Dose
Other
10 MG AM &
PT
Report Source
Product
Role
Manufacturer
Route
Drug Effect Decreased
Health
Methylphenidate Hcl
PS
Mallinckrodt Inc
ORAL
Medication Error
Professional
Duration
NOON ORAL
18-Aug-2005
Page: 100
Company Report #14562-00M/1529
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/22/00ISR Number: 3517806-3Report Type:Periodic
Age:8.5 YR Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
5MG TID ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Drug Effect Decreased
Health
Methylphenidate Hcl
PS
Mallinckrodt Inc
ORAL
Educational Problem
Professional
Product
Role
Manufacturer
Route
Generic Ritalin
PS
Date:06/26/00ISR Number: 3519104-0Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
10MG TID
Company Report #14489-00M/1415
PT
Company Report #
Report Source
Duration
Unevaluable Event
Date:06/26/00ISR Number: 3519997-7Report Type:Expedited (15-DaCompany Report #00D--10581
Age:3 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Visual Acuity Reduced
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Manufacturer
Route
Duration
DAILY, ORAL
Professional
Other
Date:06/27/00ISR Number: 3520172-0Report Type:Direct
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
1 PILL EVERY
Company Report #
PT
Report Source
Product
Role
Headache
Consumer
Ritalin
PS
Quanfacnie
SS
MORN
1 PILL EVERY
MORNING
Date:06/27/00ISR Number: 3520431-1Report Type:Expedited (15-DaCompany Report #MPI-2000-04574(0)
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Blood Creatine
Phosphokinase Increased
Literature
Methylphenidate Hcl
PS
Md Pharmaceutical
Inc
Product
Role
Manufacturer
Route
Attention
Deficit/Hyperactivity
Disorder
(Geneva)
Methylphenidate 10
Mg
PS
Geneva
ORAL
Condition Aggravated
Prozac
C
Duration
100MG/DAY,
Blood Creatine
THREE TIMES A
Phosphokinase Mb
DAY IN THREE
Increased
DOSES
Chest Pain
Emotional Distress
Hypertension
Intermittent Claudication
Myocardial Ischaemia
Tachycardia
Date:06/28/00ISR Number: 3521047-3Report Type:Direct
Age:19 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Duration
10MG BID ORAL
18-Aug-2005
Page: 101
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/30/00ISR Number: 3523158-5Report Type:Expedited (15-DaCompany Report #00GB-10368
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Rash Pustular
Scab
Foreign
Health
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Skin Lesion
Professional
Duration
20 MG, DAILY,
ORAL
Other
Date:07/03/00ISR Number: 3525243-0Report Type:Periodic
Age:62 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
Salbutamol
Pulmicort Turbohaler
C
C
Company Report #212938
PT
Report Source
Product
Role
Manufacturer
Route
Completed Suicide
Other
Klonopin
PS
Hoffmann La Roche
Inc
ORAL
Duration
1 MG 1 PER 8
HOUR ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
10 MG 2 PER
DAY ORAL
Paxil (Paroxetine)
Pavabid (Papaverine
Hydrochloride)
Date:07/03/00ISR Number: 3583856-4Report Type:Periodic
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
10 MG A.M.
C
Company Report #AR-1373
PT
Report Source
Product
Role
Manufacturer
Route
Agitation
Dizziness
Health
Professional
Methylphenidate Hcl
PS
Danbury Pharmacal
Inc
ORAL
Duration
5
Nausea
MG AT NOON
C
Sedation
(ORAL)
Vomiting
Date:07/03/00ISR Number: 3583857-6Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #AR-1374
PT
Report Source
Product
Role
Manufacturer
Route
Abnormal Behaviour
Condition Aggravated
Health
Professional
Methylphenidate Hcl
PS
Danbury Pharmacal
Inc
ORAL
Duration
10 MG 6:30
A.M., 9:30
A.M., 1 TAB.
AT NOON
(ORAL)
Date:07/03/00ISR Number: 3583859-XReport Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Company Report #AR-1375
PT
Report Source
Product
Role
Manufacturer
Route
Abnormal Behaviour
Condition Aggravated
Health
Professional
Methylphenidate Hcl
PS
Danbury Pharmacal
Inc
ORAL
Duration
10 MG
Disturbance In Attention
BREAKFAST AND
Headache
LUNCH (ORAL)
Guanfacine (Sic)
18-Aug-2005
Page: 102
11:49 AM
C
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/03/00ISR Number: 3583861-8Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Company Report #AR-1376
PT
Report Source
Product
Role
Manufacturer
Route
Abnormal Behaviour
Health
Professional
Methylphenidate Hcl
PS
Danbury Pharmacal
Inc
ORAL
Route
Duration
20 MG AM, 15
MG 10:30 AM
AND 15 MG
1:30 PM
(ORAL)
Guafacine (Sic)
Date:07/03/00ISR Number: 3583864-3Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
C
Company Report #AR-1377
PT
Report Source
Product
Role
Manufacturer
Abnormal Behaviour
Condition Aggravated
Other
Methylphenidate Hcl
PS
Danbury Pharmacal
Inc
Celexa
C
Duration
15 MG DOSE
Date:07/10/00ISR Number: 3527266-4Report Type:Expedited (15-DaCompany Report #00GB-10507
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
DAILY , ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Drug Interaction
Priapism
Foreign
Health
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Professional
Other
Risperidone
(Risperidone)
Date:07/10/00ISR Number: 3527271-8Report Type:Expedited (15-DaCompany Report #99NZ-10075
Age:23 YR
Gender:Female
I/FU:F
SS
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
70 MG DAILY
PT
Report Source
Product
Role
Manufacturer
Route
Convulsion
Syncope
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Syncope Vasovagal
Professional
Route
ORAL
Other
Date:07/18/00ISR Number: 3531187-0Report Type:Expedited (15-DaCompany Report #MPI-2000-04610 (0)
Age:55 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Choreoathetosis
Drug Abuser
Literature
Health
Methylphenidate Hcl
PS
Md Pharmaceutical
Inc
Dry Mouth
Dyskinesia
Hypomania
Movement Disorder
Pupillary Reflex Impaired
Tachycardia
Professional
Lithium (Lithium)
Methapyrilene
(Methapyrilene)
Antipshychotic
Medication
(Antipsychotics)
C
Duration
30-100MG, DAY
Date:07/21/00ISR Number: 3533745-6Report Type:Expedited (15-DaCompany Report #A024623
Age:
Gender:Female
I/FU:I
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 103
11:49 AM
C
C
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
Manufacturer
Route
Asthma
Drug Ineffective
Consumer
Zoloft
PS
Pfizer
Pharmaceuticals Inc
ORAL
50.00 MG
Fatigue
TOTAL:DAILY:O
Road Traffic Accident
RAL
Methylphenidate
SS
Ventolin
C
ORAL
ORAL
Date:07/24/00ISR Number: 3534488-5Report Type:Expedited (15-DaCompany Report #00GB-10507
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
30 MG, DAILY,
PT
Report Source
Product
Role
Manufacturer
Route
Drug Interaction
Priapism
Foreign
Health
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Professional
ORAL
1
MON
Other
Ritalin-Sr Slow
Release Tablet
(Methylphenidate
Hydrochloride)
SS
Clonidine
Risperdal
C
C
ORAL
20 MG, DAILY,
ORAL
1
MON
Date:07/25/00ISR Number: 3534561-1Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Ritalin
PS
Duration
Antisocial Behaviour
Personality Change
Manufacturer
Route
Date:07/25/00ISR Number: 3534580-5Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Life-Threatening
PT
Company Report #
Report Source
Bundle Branch Block
Cardiac Disorder
Cardiac Failure
Product
Role
Ritalin (Beginning
Dosage 5 Mg Increased To 60 Mg)
PS
Manufacturer
Route
Manufacturer
Route
ONCE A DAY
Hypertension
Myocardial Infarction
Date:07/31/00ISR Number: 3537461-6Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Ritalin-Generic
PS
Duration
Reaction To Medical Agent
P.O
Preservatives
Date:07/31/00ISR Number: 3538816-6Report Type:Expedited (15-DaCompany Report #JACGBR2000000458
Age:13 YR
Gender:Male
I/FU:I
Outcome
Hospitalization Initial or Prolonged
Disability
18-Aug-2005
Page: 104
11:49 AM
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
Manufacturer
Route
Drug Interaction
Priapism
Sedation
Foreign
Health
Professional
Risperdal
PS
Janssen Research Fdn
Div Johnson And
Johnson
ORAL
Manufacturer
Route
1 MG, 1 IN 1
DAY(S), ORAL
Ritalin Sr
(Methilphenidate
Hydrochloride)
SS
Clonidine
C
20 MG , 1 IN
1 DAY(S), 10
MG , 3 IN 1
DAY(S)
Date:08/04/00ISR Number: 3541248-8Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
10 MG TID
Company Report #
PT
Report Source
Product
Role
Aggression
Consumer
Ritalin (5-10mg)
PS
ORAL
Clonidine
SS
ORAL
Duration
Growth Retardation
ORAL
Insomnia
0.2 MG BID
Obsessive-Compulsive
ORAL
Disorder
Weight Decreased
Date:08/07/00ISR Number: 3543520-4Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #
Report Source
Product
Role
Manufacturer
Route
Other
No Adverse Drug Effect
Ritalin 20mg Tablets
(Bno)
PS
Generic Ritalin
Generic Adderall
C
C
Bno
ORAL
Manufacturer
Route
Manufacturer
Route
1T BID ORALLY
SINCE 4/99
Date:08/08/00ISR Number: 3544624-2Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Drug Ineffective
Date:08/10/00ISR Number: 3546986-9Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Required
20MG TID PO
5
YR
Intervention to
Prevent Permanent
Impairment/Damage
18-Aug-2005
Page: 105
Product
Role
Methylphenidate
PS
Duration
11:49 AM
Company Report #
PT
Report Source
Product
Role
Blood Creatine
Health
Ritalin 20mg Tid
PS
Phosphokinase Increased
Liver Function Test
Abnormal
Professional
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/14/00ISR Number: 3550521-9Report Type:Expedited (15-DaCompany Report #MPI-2000-04658 (0)
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Angiogram Cerebral
Abnormal
Literature
Health
Methylphenidate Hcl
PS
Md Pharmaceutical
Inc
Cerebellar Syndrome
Cerebral Arteritis
Computerised Tomogram
Abnormal
Coordination Abnormal
Difficulty In Walking
Dystonia
Erectile Dysfunction
Hemiparesis
Hyperreflexia
Nuclear Magnetic
Resonance Imaging
Abnormal
Paraesthesia
Precerebral Artery
Occlusion
Vasculitis
Professional
Manufacturer
Route
Duration
20 MG PER DAY
Date:08/15/00ISR Number: 3551923-7Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Required
20 MG TID PO
5
YR
Intervention to
Prevent Permanent
Impairment/Damage
Company Report #
PT
Report Source
Product
Role
Blood Creatine
Health
Ritalin 20 Mg Tid
PS
Phosphokinase Increased
Liver Function Test
Abnormal
Professional
Route
ORAL
Date:08/16/00ISR Number: 3551473-8Report Type:Expedited (15-DaCompany Report #MPI-2000-04567 (1)
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Abnormal Behaviour
Literature
Ritalin
Duration
Role
Manufacturer
Route
Required
Intervention to
AGE 5 - AGE 8
Prevent Permanent
Impairment/Damage
Aggression
Anxiety
Health
Professional
(Methylphenidate
Hydrochloride)
PS
Condition Aggravated
Depression
Disturbance In Attention
Drug Withdrawal Syndrome
Feeling Abnormal
Irritability
Medication Error
Paranoia
Psychomotor Hyperactivity
Speech Disorder
Suicidal Ideation
Date:08/22/00ISR Number: 3555733-6Report Type:Expedited (15-DaCompany Report #MPI-2000-04709(0)
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 106
PT
Report Source
Product
Role
Manufacturer
Psychotic Disorder
Company
Representative
Metadate Er
PS
Medeva
Pharmaceuticals Inc
Duration
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
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
Date:08/28/00ISR Number: 3560361-2Report Type:Expedited (15-DaCompany Report #PHFR2000GB00618
Age:15 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
10 MG/DAY
PT
Report Source
Product
Role
Manufacturer
Route
Amnesia
Overdose
Foreign
Health
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Photopsia
Professional
Respiratory Arrest
Other
ORAL
Alcohol (Ethanol)
C
Date:08/31/00ISR Number: 3565752-1Report Type:Expedited (15-DaCompany Report #PHFR1999GB00655
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Blood Alkaline
Phosphatase Increased
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Blood Bilirubin Increased
Professional
Duration
DIVIDED
DOSES:
Cholestasis
Other
15,15,10MG ,
Decreased Appetite
ORAL
Jaundice
Weight Decreased
Date:09/05/00ISR Number: 3565478-4Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #
PT
Report Source
Product
Role
Drug Ineffective
Health
Professional
Methylphenidate
PS
Manufacturer
Route
Route
Duration
Date:09/07/00ISR Number: 3567587-2Report Type:Expedited (15-DaCompany Report #MPI-2000-04731(0)
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Supraventricular
Tachycardia
Company
Representative
Metadate Er
PS
Medeva
Pharmaceuticals Inc
Duration
10 MG
Date:09/12/00ISR Number: 3570553-4Report Type:Expedited (15-DaCompany Report #PHEH2000US08076
Age:17 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 107
PT
Aggression
Anger
Drug Abuser
Murder
Mydriasis
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Overdose
Panic Attack
Psychomotor Hyperactivity
Report Source
Product
Role
Psychotic Disorder
Consumer
Ritalin Tab
PS
Prozac (Fluoxetine
Hydrochloride)
Klonopin
C
C
Manufacturer
Route
Duration
ORAL
10 MG, TID,
Suicidal Ideation
ORAL
Toxicologic Test Abnormal
Date:09/12/00ISR Number: 3570772-7Report Type:Expedited (15-DaCompany Report #MPI-2000-04709(1)
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
30 MG TWICE A
PT
Report Source
Product
Role
Manufacturer
Route
Hallucination
Psychotic Disorder
Health
Professional
Metadate Er
PS
Medeva
Pharmaceuticals Inc
ORAL
Company
DAY PO
Representative
Efexor Xr
(Venlafaxine
Hydrochloride)
SS
ORAL
75 MG EVERY
DAY PO
Date:09/18/00ISR Number: 3574574-7Report Type:Expedited (15-DaCompany Report #PHNU2000DE01585
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
20 MG, QD,
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Epistaxis
Foreign
Health
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Von Willebrand'S Disease
Professional
ORAL
Other
Date:09/18/00ISR Number: 3575224-6Report Type:Expedited (15-DaCompany Report #MPI-2000-04756 (0)
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Aggression
Drug Abuser
Other
Methylphenidate Hcl
PS
Md Pharmaceutical
Inc
Murder
Psychotic Disorder
Prozac (Fluoxetine
Hydrochloride)
SS
ORAL
Suicidal Ideation
Klonopin
(Clonazepam)
SS
ORAL
Duration
SEE IMAGE
SEE IMAGE
SEE IMAGE
Date:09/25/00ISR Number: 3579682-2Report Type:Expedited (15-DaCompany Report #PHEH2000US08181
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Coombs Direct Test
Positive
Health
Professional
Ritalin-Sr
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
30 MG, QD,
Haemolytic Anaemia
ORAL
Macrocytosis
18-Aug-2005
Page: 108
11:49 AM
Nutropin Aq
(Somatropin)
C
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/27/00ISR Number: 3581989-XReport Type:Periodic
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #AR - 1398
PT
Report Source
Product
Role
Manufacturer
Decreased Appetite
Weight Decreased
Consumer
Health
Methylphenidate 5mg
Schein
PS
Schein
Albutenol Nebulizer
Motrin Ped. Susp.
C
C
Route
Duration
1/2 TABLET
Professional
BID
Date:09/27/00ISR Number: 3581991-8Report Type:Periodic
Age:5.6 YR Gender:Female
I/FU:I
Outcome
Dose
Other
5 MG PO AM,
Company Report #AR - 1396
PT
Report Source
Product
Role
Manufacturer
Route
Abnormal Behaviour
Consumer
Methylphenidate Hcl
PS
Schein
ORAL
Aggression
Health
Condition Aggravated
Professional
Route
Duration
2.5 PM; 7 1/2
MG PO AM, 5
Drug Effect Decreased
PM
Date:10/02/00ISR Number: 3585710-0Report Type:Expedited (15-DaCompany Report #PHFR2000GB01403
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Manufacturer
Blood Pressure Increased
Cyanosis
Drug Abuser
Hyperhidrosis
Respiratory Arrest
Foreign
Health
Professional
Other
Ritalin
PS
Novartis
Pharmaceuticals Corp
Date:10/04/00ISR Number: 3586658-8Report Type:Direct
Age:12 YR
Gender:Male
I/FU:I
Company Report #
Outcome
Dose
Duration
Other
10MG 2 BID, 1
PT
Report Source
Anxiety
Product
Role
Generic Ritalin
PS
Manufacturer
Route
Disturbance In Attention
HS
Drug Ineffective
Sleep Disorder
Date:10/13/00ISR Number: 3594981-6Report Type:Expedited (15-DaCompany Report #PHBS2000JP09715
Age:16 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Abnormal Behaviour
Delusion
Foreign
Literature
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Depression
Health
Excitability
Professional
Psychotic Disorder
Other
Duration
10 MG/DAY,
ORAL
Ritaline
5 MG/DAY,
ORAL
Schizophrenia
Thought Blocking
Date:10/13/00ISR Number: 3595481-XReport Type:Expedited (15-DaCompany Report #PHFR2000GB01403
Age:15 YR
Gender:Female
I/FU:F
Outcome
Life-Threatening
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 109
11:49 AM
PT
Asthenia
Blood Pressure Increased
Circulatory Collapse
SS
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Cyanosis
Drug Abuser
Feeling Hot
Report Source
Product
Role
Manufacturer
Route
Hyperhidrosis
Respiratory Arrest
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Skin Discolouration
Professional
Visual Disturbance
Other
Manufacturer
Route
Duration
10 MG,
ONCE/SINGLE,
ORAL
Date:10/23/00ISR Number: 3599865-5Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
20 MG EVERY
PT
Company Report #
Report Source
Product
Role
Ritalin Sr 20
PS
Duration
Medication Error
ORAL
MORNING ORAL
Date:10/24/00ISR Number: 3601316-9Report Type:Expedited (15-DaCompany Report #MPI-2000-04731 (1)
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Chest Pain
Dizziness
Health
Professional
Metadate Er
PS
Medeva
Pharmaceuticals Inc
Supraventricular
Tachycardia
Tachycardia
Company
Representative
Prozac
C
Route
Duration
10 MG
Date:10/26/00ISR Number: 3602257-3Report Type:Expedited (15-DaCompany Report #PHNU2000DE01916
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization -
PT
Report Source
Product
Role
Manufacturer
Hypotonia
Foreign
Ritalin
PS
Novartis
Route
Initial or Prolonged
1.25 DF, QD,
Loss Of Consciousness
Health
Sedation
Professional
Pharmaceuticals Corp
ORAL
Route
ORAL
Other
Date:10/31/00ISR Number: 3609836-8Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #MPI-2000-04729 (0)
PT
Report Source
Product
Role
Manufacturer
Abdominal Pain
Hypersensitivity
Health
Professional
Metadate Er
PS
Medeva
Pharmaceuticals Inc
Vomiting
Company
Representative
Duration
10 MG
Date:10/31/00ISR Number: 3609842-3Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Emotional Disorder
Health
Professional
Metadate Er
PS
Medeva
Pharmaceuticals Inc
ORAL
Duration
10 MG, ONCE A
DAY, PO
18-Aug-2005
Page: 110
Company Report #MPI-2000-04633 (0)
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/31/00ISR Number: 3609845-9Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Company Report #MPI-2000-04763(0)
PT
Report Source
Product
Role
Manufacturer
Tachycardia
Health
Professional
Metadate Er
PS
Medeva
Pharmaceuticals Inc
Product
Role
Manufacturer
Salmeterol
PS
Glaxo Wellcome
Singulair
Atrovent
C
C
Glaxo Wellcome
Clonazepam
C
Respolin
Pulmicort
C
C
Glaxo Wellcome
Role
Manufacturer
Route
Duration
10 MG
Company
Representative
Date:11/01/00ISR Number: 3604026-7Report Type:Expedited (15-DaCompany Report #B0090064A
Age:82 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Death
RESPIRATORY
Hospitalization (INHALATION)
100MCG
Initial or Prolonged
PER DAY
484 DAY
PT
Report Source
Chronic Obstructive
Route
Airways Disease
TWICE
Exacerbated
2PUFF TWICE
PER DAY
.5MG AS
REQUIRED
800MCG TWICE
PER DAY
Date:11/01/00ISR Number: 3604027-9Report Type:Expedited (15-DaCompany Report #B0090065A
Age:75 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Route
Death
Cardiac Disorder
RESPIRATORY
Hospitalization (INHALATION)
50MCG TWICE
Initial or Prolonged
PER DAY
907 DAY
Salmeterol
PS
Glaxo Wellcome
Product
Role
Manufacturer
Salmeterol
PS
Glaxo Wellcome
Product
Role
Manufacturer
Salmeterol
PS
Glaxo Wellcome
Date:11/01/00ISR Number: 3604028-0Report Type:Expedited (15-DaCompany Report #B0090066A
Age:57 YR
Gender:Female
I/FU:I
Outcome
PT
Dose
Duration
Death
Death
RESPIRATORY
Life-Threatening
(INHALATION)
50MCG TWICE
Hospitalization PER DAY
124 DAY
Initial or Prolonged
Report Source
Route
Date:11/01/00ISR Number: 3604029-2Report Type:Expedited (15-DaCompany Report #B0090068A
Age:65 YR
Gender:Male
I/FU:I
Outcome
PT
Dose
Duration
Death
Chronic Obstructive
RESPIRATORY
Life-Threatening
Airways Disease
(INHALATION)
50MCG TWICE
Hospitalization Exacerbated
PER DAY
810 DAY
Initial or Prolonged
Myocardial Infarction
Report Source
Date:11/01/00ISR Number: 3604030-9Report Type:Expedited (15-DaCompany Report #B0090069A
Age:87 YR
Gender:Male
I/FU:I
Outcome
Death
Life-Threatening
18-Aug-2005
Page: 111
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hospitalization Initial or Prolonged
PT
Dose
Report Source
Product
Role
Manufacturer
Salmeterol
PS
Glaxo Wellcome
Route
Duration
Pneumonia
RESPIRATORY
(INHALATION)
PER DAY
50MCG TWICE
240
DAY
Date:11/06/00ISR Number: 3608057-2Report Type:Expedited (15-DaCompany Report #PHEH2000US09739
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Abdominal Pain Upper
Consumer
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
15 MG, BID,
Aggression
ORAL
Anger
Anxiety
Depression
Drug Dependence
Ritalin-Sr(Methylphe
nidate
Hydrochloride) Slow
Release Tablet
SS
Cocaine
SS
ORAL
30 MG, QD,
Drug Withdrawal Syndrome
ORAL
Fatigue
Headache
Hostility
Insomnia
Mental Disorder
Murder
Physical Assault
Suicidal Ideation
Weight Decreased
Date:11/06/00ISR Number: 3608162-0Report Type:Expedited (15-DaCompany Report #PHFR2000GB00671
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Other
Fundoscopy Abnormal
Optic Disc Disorder
Foreign
Health
Ritalin
Retinal Pigmentation
Professional
PS
Novartis
Pharmaceuticals Corp
ORAL
Manufacturer
Route
25 MG/DAY,
ORAL
Other
Date:11/09/00ISR Number: 3609604-7Report Type:Direct
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Life-Threatening
1 QD ORAL
PT
Company Report #
Report Source
Product
Role
Grand Mal Convulsion
Concerta 18mg
PS
ORAL
Insomnia
Wellbutrin Sr 100mg
SS
ORAL
2 BID ORAL
Medication Error
Date:11/09/00ISR Number: 3610165-7Report Type:Expedited (15-DaCompany Report #CIP00000967
Age:65 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Chills
Choking
Drug Interaction
Dyspnoea
Health
Professional
Company
Representative
Actonel
PS
Procter And Gamble
Pharmaceuticals Inc
Sub Procter And
Gambl
ORAL
Duration
5 MG DAILY,
Hypersensitivity
ORAL
Palpitations
Pharyngeal Oedema
ORAL
18-Aug-2005
Page: 112
11:49 AM
Buspar (Buspirone
Hydrochloride)
SS
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Serzone (Nefazodone
Hydrochloride)
SS
ORAL
Synthroid
(Levothyroxine
Sodium)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
ORAL
ORAL
ORAL
Date:11/13/00ISR Number: 3613368-0Report Type:Periodic
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #FLUV00299001834
PT
Report Source
Product
Role
Manufacturer
Route
Hostility
Muscle Twitching
Consumer
Luvox
PS
Solvay
Pharmaceuticals
ORAL
Duration
50 MG DAILY
PO;
75 MG
DAILY PO
Ritalin - Slow
Release
(Methylphenidate
Hydrochloride)
SS
ORAL
10 MG DAILY
PO
Date:11/20/00ISR Number: 3614618-7Report Type:Expedited (15-DaCompany Report #FLUV00300005819
Age:71 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Depressed Level Of
Consciousness
Foreign
Health
Luvox
PS
Solvay
Pharmaceuticals
ORAL
Depression
Professional
Duration
25 MG DAILY
PO,50 MG
Haemoglobin Decreased
Other
DAILY PO, 75
Leukopenia
MG DAILY PO,
Muscular Weakness
25 MG DAILY
Pancytopenia
Constan (Alprazolam)
SS
ORAL
Depas (Etizolam)
SS
ORAL
Besacolin
(Bethanechol
Chloride)
SS
ORAL
Lendormin
(Brotizolam)
SS
ORAL
Magnesium Oxide
(Magnesium Oxide)
SS
ORAL
Methylphenidate
Hydrochloride
(Methylphenidate
Hydrochloride)
SS
ORAL
Tsukushi
Miya Bm
C
C
0.8 MG DAILY
Platelet Count Decreased
PO
Splenomegaly
1 MG DAILY PO
50 MG DAILY
PO
0.5 MG DIALY
PO
1.59 G DAILY
PO
10 MG DAILY
PO
18-Aug-2005
Page: 113
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/24/00ISR Number: 3616770-6Report Type:Expedited (15-DaCompany Report #PHBS2000US08065
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Coronary Artery Disease
Myocardial Infarction
Sudden Death
Literature
Health
Professional
Ritalin
PS
Novartis
Pharmaceuticals Corp
Route
Duration
Date:11/27/00ISR Number: 3617254-1Report Type:Expedited (15-DaCompany Report #PHNU2000DE02170
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Cerebrovascular Disorder
Facial Palsy
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
ORAL
Professional
Other
Date:12/01/00ISR Number: 3624878-4Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18 MG - 36 MG
Company Report #6980
PT
Report Source
Product
Role
Manufacturer
Route
Anorexia
Consumer
Concerta
PS
Alza Corp
ORAL
Drug Ineffective
1 X /
1 DAY
ORAL
Date:12/01/00ISR Number: 3624879-6Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG 1 X
/1DAY, ORAL
Company Report #6984
PT
Report Source
Product
Role
Manufacturer
Route
Agitation
Health
Concerta
PS
Alza Corp
ORAL
Emotional Disorder
Professional
Duration
Insomnia
Company
Representative
Date:12/01/00ISR Number: 3624880-2Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18 MG - 36MG
Imipramine
Zyprexa
C
C
Company Report #6985
PT
Report Source
Product
Role
Manufacturer
Agitation
Consumer
Concerta
PS
Alza Corp
Route
Drug Ineffective
1 X /1 DAY
Mania
Date:12/01/00ISR Number: 3624881-4Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #6993
PT
Report Source
Product
Role
Manufacturer
Route
Muscle Twitching
Health
Concerta
PS
Alza Corp
ORAL
Professional
ORAL
Company
Representative
18-Aug-2005
Page: 114
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/01/00ISR Number: 3624882-6Report Type:Periodic
Age:13 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
36MG 1X/1DAY,
Company Report #6994
PT
Report Source
Product
Role
Manufacturer
Route
Dermatitis
Consumer
Concerta
PS
Alza Corp
ORAL
Wellbutrin Sr
C
ORAL
Date:12/01/00ISR Number: 3624883-8Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #6999
PT
Report Source
Product
Role
Manufacturer
Route
Drug Effect Decreased
Consumer
Concerta
PS
Alza Corp
ORAL
Tegretol
Neurontin
Luvox
C
C
C
Route
ORAL
Date:12/01/00ISR Number: 3624884-XReport Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Concerta
PS
Alza Corp
Duration
Dyspepsia
Date:12/01/00ISR Number: 3624885-1Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Other
ORAL,
Company Report #7633
Company Report #7641
PT
Report Source
Product
Role
Manufacturer
Route
Mydriasis
Health
Concerta
PS
Alza Corp
ORAL
Duration
Professional
DOSE/FREQ UNK
Company
Representative
Date:12/01/00ISR Number: 3624886-3Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Diarrhoea
Health
Professional
Company
Representative
Concerta
PS
Alza Corp
Company Report #7665
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Consumer
Concerta
PS
Alza Corp
ORAL
..
C
Duration
1X/1DAY,ORAL;
18MG 2 TABS 1
X /DAY;18MG
1X/DAY,ORAL
18-Aug-2005
Page: 115
Route
Duration
Date:12/01/00ISR Number: 3624887-5Report Type:Periodic
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36MG
Company Report #7642
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/01/00ISR Number: 3624888-7Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36M
Company Report #6899
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Health
Concerta
PS
Alza Corp
ORAL
Hallucination
Professional
Paxil
Buspar
C
C
Duration
1X/1DAY,ORAL
Nausea
Vomiting
Date:12/01/00ISR Number: 3624889-9Report Type:Periodic
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
75MG
Company Report #6951
PT
Report Source
Product
Role
Manufacturer
Route
Arrhythmia
Consumer
Concerta
PS
Alza Corp
ORAL
Chest Pain
Health
Condition Aggravated
Hyperhidrosis
Insomnia
Overdose
Palpitations
Professional
Depakote
C
Duration
1X/1DAY,ORAL
Date:12/01/00ISR Number: 3624890-5Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
DOSE
Company Report #6952
PT
Report Source
Product
Role
Manufacturer
Route
Pollakiuria
Health
Concerta
PS
Alza Corp
ORAL
Duration
Professional
UNKN-ORAL
Company
Representative
Date:12/01/00ISR Number: 3624891-7Report Type:Periodic
Age:14 YR
Gender:Female
I/FU:I
Company Report #6954
Outcome
Dose
Other
36MG
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Depakote
SS
Duration
Dizziness
1X/1DAY,ORAL
250MG QAM &
500MG QHS
Date:12/01/00ISR Number: 3624892-9Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #6957
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Consumer
Concerta
PS
Alza Corp
ORAL
Hostility
Health
Prozac
SS
Zoloft
SS
ORAL
Professional
15MG 1X/1DAY
ORAL
25MG
1X/1DAY,PO
Date:12/01/00ISR Number: 3624893-0Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG
Company Report #6961
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Celexa
C
Duration
1X/1DAY,PO
18-Aug-2005
Page: 116
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/01/00ISR Number: 3624896-6Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #6969
PT
Report Source
Product
Role
Manufacturer
Route
Emotional Disorder
Consumer
Concerta
PS
Alza Corp
ORAL
Rhinitis
ORAL
Date:12/01/00ISR Number: 3624897-8Report Type:Periodic
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18MG
Company Report #6976
PT
Report Source
Product
Role
Manufacturer
Route
Dizziness
Health
Concerta
PS
Alza Corp
ORAL
Pallor
Professional
Duration
1X/1DAY,ORAL
Date:12/01/00ISR Number: 3624898-XReport Type:Periodic
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36MG
Company Report #6978
PT
Report Source
Product
Role
Manufacturer
Route
Hyperhidrosis
Consumer
Concerta
PS
Alza Corp
ORAL
Prozac
C
Duration
1X/1DAY,ORAL
Date:12/01/00ISR Number: 3624900-5Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
ORAL
Company Report #6979
PT
Report Source
Product
Role
Manufacturer
Route
Pruritus
Health
Concerta
PS
Alza Corp
ORAL
Urticaria
Professional
Company
Representative
Duration
Date:12/01/00ISR Number: 3625300-4Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
54 MG 1X/ 1
Company Report #7669
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Health
Concerta
PS
Alza Corp
ORAL
Duration
Professional
DAY, ORAL
Date:12/01/00ISR Number: 3625301-6Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG 1 X /
Company Report #7671
PT
Report Source
Product
Role
Manufacturer
Route
Depersonalisation
Health
Concerta
PS
Alza Corp
ORAL
Headache
Professional
Nausea
Company
Representative
Route
Duration
DAY ORAL
Date:12/01/00ISR Number: 3625302-8Report Type:Periodic
Age:40 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
54 MG > TO 72
Company Report #7672
PT
Report Source
Product
Role
Manufacturer
Haemorrhage
Consumer
Concerta
PS
Alza Corp
Ritalin
Methotrexate
C
C
MG 1X / 1
DAY,
18-Aug-2005
Page: 117
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Wellbutrin
Celexa
Vioxx
Allegra
Diovan
Pepcid
Flonase
Niacin
Date:12/01/00ISR Number: 3625304-1Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18 MG - 36 PO
C
C
C
C
C
C
C
C
Company Report #7684
PT
Report Source
Product
Role
Manufacturer
Hallucination
Health
Concerta
PS
Alza Corp
Headache
Professional
Visual Disturbance
Company
Representative
Zyrtec
C
Route
1X/ 1 DAY
Date:12/01/00ISR Number: 3625305-3Report Type:Periodic
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
36 MG 1X/ 1
Company Report #7686
PT
Report Source
Product
Role
Manufacturer
Route
Dermatitis
Health
Concerta
PS
Alza Corp
ORAL
Duration
Professional
DAY, ORAL
Date:12/01/00ISR Number: 3625306-5Report Type:Periodic
Age:18 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
54 MG 1 X / 1
Company Report #7706
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Consumer
Concerta
PS
Alza Corp
ORAL
Wellbutrin
C
Confusional State
DAY, ORAL
Insomnia
Speech Disorder
Date:12/01/00ISR Number: 3625307-7Report Type:Periodic
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
54 MG 1 X / 1
Company Report #7707
PT
Report Source
Product
Role
Manufacturer
Route
Abnormal Behaviour
Consumer
Concerta
PS
Alza Corp
ORAL
Drug Ineffective
DAY , ORAL
Date:12/01/00ISR Number: 3625309-0Report Type:Periodic
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36 MG 1 X / 1
Company Report #7710
PT
Report Source
Product
Role
Manufacturer
Route
Urticaria
Health
Concerta
PS
Alza Corp
ORAL
Professional
DAY , PO
Company
Representative
18-Aug-2005
Page: 118
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/01/00ISR Number: 3625311-9Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18 MG 1 X/ 1
Company Report #7711
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Health
Concerta
PS
Alza Corp
ORAL
Laryngeal Oedema
Professional
Palpitations
Pruritus
Company
Representative
DAY, ORAL
Date:12/01/00ISR Number: 3625312-0Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG 1X/ 1
Company Report #7712
PT
Report Source
Product
Role
Manufacturer
Route
Urticaria
Health
Concerta
PS
Alza Corp
ORAL
Duration
Professional
DAY , ORAL
Company
Representative
Date:12/01/00ISR Number: 3625314-4Report Type:Periodic
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18 MG 1 X/ 1
Company Report #7719
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Consumer
Concerta
PS
Alza Corp
ORAL
Insomnia
DAY, ORAL
Muscle Twitching
Nervousness
Pain
Date:12/01/00ISR Number: 3625315-6Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Company Report #7727
Outcome
Dose
Other
36 MG 1X/ 1
PT
Report Source
Product
Role
Manufacturer
Route
Insomnia
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
DAY, ORAL
Date:12/05/00ISR Number: 3622696-4Report Type:Expedited (15-DaCompany Report #PHNU2000DE02259
Age:44 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
2 DF, TID,
PT
Report Source
Product
Role
Manufacturer
Route
Cardiomegaly
Dyspnoea
Foreign
Consumer
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Heart Rate Increased
Other
Manufacturer
Route
ORAL
Hyperhidrosis
Date:12/11/00ISR Number: 3626760-5Report Type:Expedited (15-DaCompany Report #MPI-2000-04574(1)
Age:16 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Pressure Increased
Emotional Distress
Heart Rate Increased
Literature
Ritalin
(Methylphenidate
Hydrochloride)
PS
Duration
100MG/DAY (IN
Intermittent Claudication
THREE DOSES)
Myocardial Ischaemia
18-Aug-2005
Page: 119
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/13/00ISR Number: 3629216-9Report Type:Expedited (15-DaCompany Report #7835
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 36MG 1X/DAY,
Initial or Prolonged
ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Arthralgia
Consumer
Concerta
PS
Alza Corp
ORAL
Myalgia
Red Blood Cell
Sedimentation Rate
Increased
White Blood Cell Count
Increased
Date:12/13/00ISR Number: 3629507-1Report Type:Expedited (15-DaCompany Report #PHFR2000GB02022
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Circulatory Collapse
Hyperventilation
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Professional
Other
Klaricid
(Clarithromycin)
Duration
ORAL
C
Date:12/14/00ISR Number: 3630240-0Report Type:Expedited (15-DaCompany Report #PHNU2000DE02170
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Facial Palsy
Herpes Virus Infection
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
ORAL
Professional
Other
Date:12/15/00ISR Number: 3631713-7Report Type:Expedited (15-DaCompany Report #PHRM2000FR01504
Age:45 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Intentional Misuse
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
500 MG,
Professional
ONCE/SINGLE,
ORAL
Date:12/18/00ISR Number: 3633261-7Report Type:Expedited (15-DaCompany Report #PHFR2000GB02126
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Oculogyration
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Manufacturer
Route
Duration
30 MG DAY
Professional
ORAL
Other
Date:12/19/00ISR Number: 3633742-6Report Type:Direct
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Generic
Methylphenidate
PS
Duration
Drug Ineffective
18-Aug-2005
Page: 120
Company Report #
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/21/00ISR Number: 3635559-5Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Ritalin (5mg)
PS
Manufacturer
Route
Manufacturer
Route
Route
Duration
Drug Effect Decreased
1T NOON,
SEVERAL YEARS
Date:12/21/00ISR Number: 3635560-1Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Ritalin 5
PS
Duration
No Adverse Drug Effect
1 1/ 2 AM 1T
PM FOR PAST
SEVERAL YEARS
7
YR
Date:12/21/00ISR Number: 3635682-5Report Type:Expedited (15-DaCompany Report #PHEH2000US11269
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Abdominal Pain Upper
Aggression
Depression
Fatigue
Headache
Insomnia
Physical Assault
Weight Decreased
Consumer
Ritalin
PS
Novartis
Pharmaceuticals Corp
Role
Manufacturer
Duration
Date:12/22/00ISR Number: 3636064-2Report Type:Expedited (15-DaCompany Report #7922
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Route
Other
18 MG 1X/1
Dizziness
Health
Fall
Professional
Loss Of Consciousness
Company
Representative
Concerta
PS
Alza Corp
ORAL
DAY, ORAL
Date:12/26/00ISR Number: 3638133-XReport Type:Expedited (15-DaCompany Report #PHEH2000US11194
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Hallucination, Visual
Health
Professional
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
10 MG, BID,
ORAL
Antihistaminics
(Antihistaminics)
Date:01/03/01ISR Number: 3641648-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000196
Age:40 YR
Gender:Female
I/FU:F
Outcome
Hospitalization Initial or Prolonged
Other
18-Aug-2005
Page: 121
11:49 AM
PT
Arthralgia
Asthenia
Blood Potassium Decreased
Carpal Tunnel Syndrome
Cholelithiasis
Cholestasis
C
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Decreased Activity
Dental Caries
Depression
Dose
Report Source
Product
Role
Manufacturer
Route
Consumer
Neurontin
PS
Parke Davis
Pharmaceuticals Ltd
ORAL
Duration
Difficulty In Walking
Dry Mouth
900 MG(300 MG
Fall
TID):2400MG(8
Fatigue
00MG
Gallbladder Disorder
TID):2100MG(7
Gallbladder Pain
00MG
Headache
Baclofen
SS
ORAL
Hypothyroidism
Ms Contin
SS
Joint Dislocation
Lethargy
Propulsid
Methadone
SS
SS
Liver Function Test
Percocet
SS
Lymphadenopathy
Valium
SS
Malnutrition
Zanaflex
SS
ORAL
Movement Disorder
Zoloft
SS
ORAL
Hydrochlorothiazide
SS
ORAL
Veetids
SS
ORAL
Synthroid
Oxy Ir (Oxycodone
SS
80 MG PER
Hypoaesthesia
ORAL
1600 MG
2500 MG
1 OR 2 (Q 4 H
Abnormal
PRN)
80 MG
8 MG PER ORAL
200 MG PER
Nervous System Disorder
ORAL
Oedema Peripheral
100 MG PER
Osteoporosis
ORAL
Ovarian Cyst
2000 MG PER
Pain In Extremity
ORAL
1
WK
Pruritus
Skin Discolouration
Skin Ulcer
Hydrochloride)
SS
Tendon Disorder
Lasix
SS
Vomiting
Ritalin
SS
Weight Decreased
K-Dur
SS
Weight Increased
Seroquel
Ketamine
Klonopin
Corgard
Relafen
Celebrex
SS
SS
SS
SS
SS
SS
Carafate
SS
Dextromethorphan
SS
Nadolol
Tegaderm
SS
SS
8-10 DAILY
80 MG
80 MG
20 MCG
800 MG
4 MG
200 MG
Date:01/10/01ISR Number: 3645534-2Report Type:Direct
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
1T PO TID
PT
Company Report #
Report Source
Product
Role
Ritalin (10mg)
PS
Manufacturer
Route
Duration
Abdominal Pain Upper
ORAL
Date:01/10/01ISR Number: 3645551-2Report Type:Expedited (15-DaCompany Report #CIP00000967
Age:65 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Chills
Choking
Drug Hypersensitivity
Drug Interaction
Health
Professional
Company
Representative
Actonel
PS
Procter And Gamble
Pharmaceuticals Inc
Sub Procter And
Gambl
ORAL
Duration
5 MG TWICE
Dyspnoea
DAILY, ORAL
Palpitations
Pharyngeal Oedema
Throat Tightness
18-Aug-2005
Page: 122
11:49 AM
Buspar (Buspirone
Hydrochloride)
Serzone (Nefazodone
SS
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hydrochloride)
SS
ORAL
Synthroid
(Levothyroxine
Sodium)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
300 MG IN THE
EVENING, ORAL
/ 150 MG AM &
300 MG PM,
ORAL
0.75 MG
DAILY, ORAL
ORAL
Date:01/10/01ISR Number: 3645583-4Report Type:Direct
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
72MG Q AM
PT
Company Report #
Report Source
Product
Role
Concerta 72mg Q Am
PS
Manufacturer
Route
Duration
Dizziness
Vomiting
Date:01/16/01ISR Number: 3648759-5Report Type:Expedited (15-DaCompany Report #PHBS2000AU08649
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Aplastic Anaemia
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
ORAL
Professional
Other
Date:01/17/01ISR Number: 3649160-0Report Type:Expedited (15-DaCompany Report #MPI-2000-04709 (2)
Age:
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Abnormal Behaviour
Hallucinations, Mixed
Psychotic Disorder
Health
Professional
Company
Metadate Er
PS
Medeva
Pharmaceuticals Ca
Inc
Representative
Efexor
Xr(Venlafaxine
Hydrochloride)
SS
Route
TWICE A DAY
75 , EVERY
DAY
Date:01/17/01ISR Number: 3649326-XReport Type:Expedited (15-DaCompany Report #PHEH2001US00560
Age:79 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Abnormal Behaviour
Aggression
Consumer
Ritalin
PS
Novartis
Pharmaceuticals Corp
Zyprexa (Olanzapine)
Oxycodone
C
C
Duration
5 MG, QD; 5
Dementia Alzheimer'S Type
MG, BID
Dermatitis
Pruritus
Date:01/17/01ISR Number: 3649689-5Report Type:Expedited (15-DaCompany Report #PHRM2000FR01504
Age:45 YR
Gender:Female
I/FU:F
Outcome
Death
18-Aug-2005
Page: 123
PT
Intentional Misuse
11:49 AM
Report Source
Foreign
Health
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Professional
Other
Dose
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
500 MG,
ONCE/SINGLE,
ORAL
Meprobamate
Amisulpride
Codeine
Lorazepam
Acepromazine
Paracetamol
Propanolol
SS
SS
C
C
C
C
C
Date:01/19/01ISR Number: 3651598-2Report Type:Expedited (15-DaCompany Report #PHNU2001DE00478
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Pulmonary Hypertension
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Route
Duration
ORAL
Professional
Other
Date:01/22/01ISR Number: 3652960-4Report Type:Expedited (15-DaCompany Report #PHEH2001US00655
Age:
Gender:
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Asthenia
Paraesthesia
Health
Professional
Ritalin
PS
Novartis
Pharmaceuticals Corp
Date:01/22/01ISR Number: 3652961-6Report Type:Expedited (15-DaCompany Report #PHEH2001US00654
Age:
Gender:
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Asthenia
Paraesthesia
Health
Professional
Ritalin
PS
Novartis
Pharmaceuticals Corp
Route
Date:01/29/01ISR Number: 3657246-XReport Type:Expedited (15-DaCompany Report #PHBS2001JP00910
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
Anafranil
SS
Wintermin
Serenace
C
C
Duration
TRANSPLACENTAL
Complications Of Maternal
Exposure To Therapeutic
TRANSPLACENTA
Drugs
Professional
L
TRANSPLACENTAL
Convulsion Neonatal
TRANSPLACENTA
L
Date:02/02/01ISR Number: 3663605-1Report Type:Periodic
Age:27 YR
Gender:Female
I/FU:I
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 124
11:49 AM
PT
Abdominal Pain
Amenorrhoea
Company Report #HQ6586830MAY2000
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Application Site Reaction
Dose
Report Source
Product
Role
Consumer
Norplant System
(Levonorgestrel,
Implant)
PS
Fluoxetine
Diazepam
Methylphenidate
C
C
I
SUBCUTANEOUS
Route
Manufacturer
Route
SUBCUTANEOUS
Date:02/05/01ISR Number: 3662759-0Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
10.00 MG
Manufacturer
Duration
Company Report #A015134
PT
Report Source
Product
Role
Hostility
Health
Zyrtec Tablets
PS
Ritalin
Valium
SS
SS
Duration
ORAL
Professional
TOTAL:DAILY:O
RAL
DAILY
Date:02/05/01ISR Number: 3663486-6Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #PHEH1999US17294
PT
Report Source
Product
Role
Manufacturer
Route
Convulsion
Health
Professional
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
10 MG, BID,
Other
ORAL
Date:02/05/01ISR Number: 3663487-8Report Type:Periodic
Age:5 YR
Gender:Male
I/FU:I
Company Report #PHEH2000US03611
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Dyskinesia
Other
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Risperidone
(Risperidone)
Solution, 1.2mg
SS
Tegretal
(Carbamazepine)
Depakote
C
C
ORAL
1.2 MG, QD,
ORAL
Date:02/05/01ISR Number: 3663488-XReport Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
20 MG, BID,
ORAL
6
Company Report #PHEH2000US04072
PT
Report Source
Product
Role
Manufacturer
Route
Tardive Dyskinesia
Other
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
MON
Risperidone
(Risperidone) Tablet
SS
Paxil (Paroxetine
Hydrochloride)
Tablet, 20 Mg
SS
Depakote
C
MG, QD
20 MG, QD,
ORAL
18-Aug-2005
Page: 125
6
MON
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/05/01ISR Number: 3663489-1Report Type:Periodic
Age:7 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Life-Threatening
Hospitalization 1) 40 MG, QD,
Initial or Prolonged
ORAL; 2) 20
Company Report #PHEH2000US07991
PT
Report Source
Product
Role
Manufacturer
Route
Convulsion
Health
Professional
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
MG QD, ORAL
Tegretol
(Carbamazepine)
Date:02/05/01ISR Number: 3663490-8Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
ORAL
Company Report #PHEH2000US09745
PT
Report Source
Product
Role
Manufacturer
Route
Arrhythmia
Hypertension
Health
Professional
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
1460 DAY
Ritalin-Sr
(Methylphenidate
Hydrochloride) Slow
Release Tablet
ORAL
C
SS
ORAL
1460 DAY
Date:02/06/01ISR Number: 3661388-2Report Type:Expedited (15-DaCompany Report #10130
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Death
36MG 1X/1DAY,
PT
Report Source
Product
Role
Manufacturer
Route
Completed Suicide
Health
Concerta
PS
Alza Corp
ORAL
Zoloft
C
Professional
ORAL
Company
Representative
Date:02/07/01ISR Number: 3660812-9Report Type:Expedited (15-DaCompany Report #A0138544A
Age:15 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization 450MG Per day 1
YR
Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Convulsion
Wellbutrin
PS
Glaxo Wellcome
ORAL
Drug Interaction
Doxycycline
Acne Medication
C
C
Methylphenidate
I
Manufacturer
Route
TOPICAL
18MG Per day
Date:02/08/01ISR Number: 3662243-4Report Type:Direct
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Ritalin 15mg
(10+5mg) Generic
PS
Ritalin 15mg
(10+5mg)
SS
Duration
Drug Ineffective
15MG BID
-MOUTH
15MG BID
-MOUTH
Date:02/08/01ISR Number: 3662872-8Report Type:Expedited (15-DaCompany Report #A0138544A
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 450 MG/PER
Initial or Prolonged
DAY/ORAL
1
YR
18-Aug-2005
Page: 126
11:49 AM
PT
Report Source
Product
Role
Manufacturer
Route
Convulsion
Health
Wellbutrin Sr
PS
Glaxo Wellcome Inc
ORAL
Drug Interaction
Professional
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Methylphenidate
(Formulation
Unknown)
SS
Doxycyline
Acne Medication
C
C
18 MG/PER DAY
Date:02/09/01ISR Number: 3665904-6Report Type:Periodic
Age:54 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
Company Report #00-10-0117
PT
Report Source
Product
Role
Manufacturer
Route
Constipation
Dry Mouth
Sedation
Consumer
Thalomid
(Thalidomide 50 Mg)
Capsules
PS
Celgene Corp
ORAL
Ritalin Tablets
SS
Estrace
Vitamin Nos
Herbal Preparation
C
C
C
Duration
100 MG QD
Thinking Abnormal
ORAL
Tremor
ORAL
ORAL
Date:02/12/01ISR Number: 3663416-7Report Type:Expedited (15-DaCompany Report #254260
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
366 DAY
PT
Product
Role
Manufacturer
Aggression
Accutane Capsules
PS
Roche
Depression
Panic Attack
Sleep Disorder
Ritalin
SS
Date:02/12/01ISR Number: 3663813-XReport Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
Report Source
Route
Duration
PT
Company Report #
Report Source
Product
Duration
Medication Error
Metadate Er 10mg
Role
Manufacturer
Route
Tabs
PS
Methadone 10 Mg Tabs
SS
10 MG QD
Date:02/13/01ISR Number: 3665029-XReport Type:Expedited (15-DaCompany Report #PHBS2001JP00910
Age:3 DY
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Foreign
Health
Professional
Other
Ritalin Tab
Anafranil(Clomiprami
ne Hydrochloride)
Tablet
Wintermin(Chlorproma
zine Hydrochloride)
PS
Duration
TRANSPLACENTAL
Clonic Convulsion
Complications Of Maternal
Exposure To Therapeutic
Drugs
Convulsion Neonatal
Dyskinesia
TRANSPLACENTA
Jaundice Neonatal
SS
SS
L
Neonatal Disorder
TRANSPLACENTAL
Serenace(Haloperidol
)
Contomin(Chlorpromaz
ine Hydrochloride)
SS
SS
TRANSPLACENTA
L
Artane(Trihexyphenid
yl Hydrochloride)
TRANSPLACENTAL
TRANSPLACENTA
L
18-Aug-2005
Page: 127
11:49 AM
SS
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/13/01ISR Number: 3665357-8Report Type:Expedited (15-DaCompany Report #254260
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
2 PER DAY
PT
Report Source
Product
Role
Manufacturer
Route
Aggression
Consumer
Accutane
PS
Hlr Technology
ORAL
Ritalin
(Methylphenidated
Hydrochloride)
SS
Duration
Depression
ORAL
Panic Attack
Sleep Disorder
ORAL
ORAL
Date:02/15/01ISR Number: 3666633-5Report Type:Expedited (15-DaCompany Report #PHBS2001NL01558
Age:35 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Manufacturer
Route
Shock
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
PS
Novartis
Pharmaceuticals
Corp. Clinical
Safety And
Epidemiology
ORAL
Manufacturer
Route
2 DF, QID,
ORAL
Morphine
Hydrochloride
Ampoule
SS
Amitriptyline Tablet
Zoplicon Tablet
Seroxat Tablet
C
C
C
5 MG/DAY
Date:02/15/01ISR Number: 3666634-7Report Type:Expedited (15-DaCompany Report #PHNU2001DE00642
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Haematoma
Foreign
Ritalin-Sr(Methylphe
Duration
Role
Thrombocytopenia
Health
Professional
Other
nidate
Hydrochloride) Slow
Release Tablet
PS
Novartis
Pharmaceuticals
Corp.
ORAL
Manufacturer
Route
20 MG, QD,
ORAL
Zyrtec (Cetirizine
Hydrochloride)
C
Date:02/16/01ISR Number: 3667396-XReport Type:Expedited (15-DaCompany Report #PHEH2001US01470
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Suicidal Ideation
Weight Increased
Consumer
Ritalin
(Methylphenidate
Hydrochloride)
PS
ORAL
Risperdal
(Risperidone)
SS
ORAL
ORAL
1) 0.5 MG,
TID, ORAL;
2) 2.5 MG,
QD, ORAL
Ddavp (Desmopressin)
Zoloft (Sertraline
Hydrochloride)
Buspar (Buspirone
18-Aug-2005
Page: 128
11:49 AM
C
C
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hydrochloride)
C
Date:02/16/01ISR Number: 3667530-1Report Type:Expedited (15-DaCompany Report #PHBS2001JP00910
Age:3 DY
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Foreign
Health
Professional
Anafranil(Clomiprami
ne Hydrochloride)
Tablet
PS
Ritaline(Methylpheni
date Hydrochloride)
Tablet
SS
Wintermin(Chlorproma
zine Hydrochloride)
SS
Serenace(Haloperidol
)
SS
Contomin(Chlorpromaz
ine Hydrcochloride)
SS
Artane(Trihexyphenid
yl Hydrochloride)
SS
Duration
TRANSPLACENTAL
Clonic Convulsion
Complications Of Maternal
Exposure To Therapeutic
TRANSPLACENTA
Drugs
Other
L
TRANSPLACENTAL
Convulsion Neonatal
Crying
Dyskinesia Neonatal
TRANSPLACENTA
Jaundice Neonatal
L
TRANSPLACENTAL
TRANSPLACENTA
L
TRANSPLACENTAL
TRANSPLACENTA
L
TRANSPLACENTAL
TRANSPLACENTA
L
TRANSPLACENTAL
TRANSPLACENTA
L
Date:02/22/01ISR Number: 3669407-4Report Type:Expedited (15-DaCompany Report #MPI-2001-00073(0)
Age:
Gender:
I/FU:I
Manufacturer
Route
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Depression
Foreign
Literature
Health
Professional
Methylphenidate Hcl
PS
Md Pharmaceutical
Inc
Route
Date:02/22/01ISR Number: 3669935-1Report Type:Expedited (15-DaCompany Report #PHFR2001GB00735
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Eosinophilia
Hepatosplenomegaly
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Pericardial Effusion
Pleural Effusion
Professional
Other
Date:02/26/01ISR Number: 3670035-5Report Type:Direct
Age:35 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Manufacturer
Route
Concerta (36mg) Alza
Pharm
PS
Alza Pharm
ORAL
Duration
Hepatitis
36MG PO QD
18-Aug-2005
Page: 129
Company Report #
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/26/01ISR Number: 3670732-1Report Type:Expedited (15-DaCompany Report #PHNU2001DE00652
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Dyskinesia
Dysphagia
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Paresis
Professional
Speech Disorder
Other
Duration
10 MG, BID,
ORAL
Date:02/26/01ISR Number: 3670874-0Report Type:Expedited (15-DaCompany Report #PHNU2001DE00694
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ventricular Extrasystoles
Foreign
Health
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Route
Duration
1.5 - 0.5,
Professional
ORAL
730
DAY
Other
Date:02/28/01ISR Number: 3681336-9Report Type:Periodic
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
Company Report #A010258
PT
Report Source
Product
Role
Manufacturer
Surgery
Tremor
Health
Professional
Zoloft
PS
Pfizer
Pharmaceuticals Inc
Ritalin
SS
Imitrex Nasal Spray
Clonidine
C
C
Duration
50.00 MG
TOTAL
110.00 MG
TOTAL:TID:ORA
L
ORAL
Date:02/28/01ISR Number: 3683192-1Report Type:Periodic
Age:8 YR
Gender:
I/FU:I
Outcome
Dose
Other
Company Report #A016005
PT
Report Source
Product
Role
Manufacturer
Drug Interaction
Mania
Health
Professional
Zoloft
PS
Pfizer
Pharmaceuticals Inc
Ritalin
SS
Route
Duration
50.00 MG
Company
TOTAL:DAILY
Representative
30.00 MG
TOTAL:DAILY
Date:02/28/01ISR Number: 3683193-3Report Type:Periodic
Age:10 YR
Gender:
I/FU:I
Outcome
Dose
Other
Company Report #A016011
PT
Report Source
Product
Role
Manufacturer
Drug Interaction
Mania
Health
Professional
Zoloft
PS
Pfizer
Pharmaceuticals Inc
Ritalin
SS
Duration
50.00 MG
Company
TOTAL:DAILY
Representative
30.00 MG
TOTAL:DAILY
Date:02/28/01ISR Number: 3683204-5Report Type:Periodic
Age:14 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 130
PT
Agitation
Attention
11:49 AM
Company Report #A015780
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Deficit/Hyperactivity
Disorder
Mania
Dose
Report Source
Product
Role
Manufacturer
Route
Health
Professional
Zoloft
PS
Pfizer
Pharmaceuticals Inc
ORAL
Duration
50.00 MG
TOTAL:DAILY:O
RAL
Ritalin
SS
30.00 MG
TOTAL:DAILY
Date:02/28/01ISR Number: 3683205-7Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Other
Company Report #A015783
PT
Report Source
Product
Role
Manufacturer
Route
Mania
Health
Professional
Zoloft
PS
Pfizer
Pharmaceuticals Inc
ORAL
Duration
50.00 MG
Company
TOTAL:DAILY:O
Representative
RAL
Ritalin
SS
30.00 MG
TOTAL:DAILY
Date:03/02/01ISR Number: 3673506-0Report Type:Expedited (15-DaCompany Report #PHFR2000GB02126
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Dyskinesia
Eye Movement Disorder
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Myopia
Professional
Duration
15 MG, BID,
ORAL
Oculogyration
Tic
Vision Blurred
Other
Date:03/05/01ISR Number: 3674153-7Report Type:Expedited (15-DaCompany Report #PHFR1999GB00655
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Blood Alkaline
Phosphatase Increased
Foreign
Health
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Blood Bilirubin Increased
Professional
Cholestasis
Other
Duration
DIVIDED
DOSES:
15,
15, 10MG,
Decreased Appetite
ORAL
Gilbert'S Syndrome
Jaundice
Weight Decreased
Date:03/05/01ISR Number: 3674484-0Report Type:Expedited (15-DaCompany Report #PHBS2000JP09475
Age:24 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
10
PT
Report Source
Product
Role
Manufacturer
Route
Decreased Appetite
Drug Dependence
Foreign
Literature
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Drug Withdrawal Syndrome
Health
Fatigue
Professional
Malaise
Overdose
Other
TABLETS/DAY,
ORAL
18-Aug-2005
Page: 131
11:49 AM
Tryptanol
(Amitriptyline
Hydrochloride)
Dogmatyl (Sulpiride)
C
C
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Horizon
Rohypnol
(Flunitrazepam)
Doral (Quazepam)
Contomin
(Chlorpromazine
Hydrochloride)
Pyrethia
Date:03/05/01ISR Number: 3679185-0Report Type:Periodic
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36MG 1X/1
C
C
C
C
C
Company Report #10116
PT
Report Source
Product
Role
Manufacturer
Route
Blood Alkaline
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
Phosphatase Increased
DAY, ORAL
Date:03/05/01ISR Number: 3679186-2Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG 1X/1
Company Report #10117
PT
Report Source
Product
Role
Manufacturer
Route
Muscle Twitching
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
DAY, ORAL
Date:03/05/01ISR Number: 3679187-4Report Type:Periodic
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG (2-18MG)
Company Report #10118
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Consumer
Concerta
PS
Alza Corp
ORAL
Sedation
1X1/DAY, PO
Concerta
(Methylphenidate
Hcl)
18MG
SS
ORAL
1X/1
DAY, PO
Date:03/05/01ISR Number: 3679188-6Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG 1X/1
Company Report #10119
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Consumer
Concerta
PS
Alza Corp
ORAL
Clonidine
C
Route
Duration
Tremor
DAY, ORAL
Date:03/05/01ISR Number: 3679189-8Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 132
Company Report #10120
PT
Report Source
Product
Role
Manufacturer
Convulsion
Health
Professional
Company
Representative
Concerta
PS
Alza Corp
Duration
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/05/01ISR Number: 3679190-4Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG 1X/1DAY,
Company Report #10123
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Health
Concerta
PS
Alza Corp
ORAL
Concerta
(Methylphenidate
Hcl)
SS
Concerta
(Methylphenidate
Hcl)
SS
Professional
ORAL
36MG (2-18MG
TABLETS QD).
ORAL
18MG 1X/1DAY,
ORAL
Date:03/05/01ISR Number: 3679191-6Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG 1X/1DAY
Company Report #10124
PT
Report Source
Product
Role
Manufacturer
Drug Ineffective
Health
Concerta
PS
Alza Corp
Professional
Concerta
(Methylphenidate
Hcl)
SS
Concerta
(Methylphenidate
Hcl)
SS
Route
36MG (2-18MG
TABLETS QD)
18MG
1X/1DAY, ORAL
ORAL
Date:03/05/01ISR Number: 3679192-8Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #10145
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Consumer
Concerta
PS
Alza Corp
ORAL
Route
ORAL
Date:03/05/01ISR Number: 3679193-XReport Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
72MG (2-36MG)
Company Report #10149
PT
Report Source
Product
Role
Manufacturer
Muscle Twitching
Consumer
Concerta
PS
Alza Corp
Concerta
(Methylphenidate
Hcl)
SS
Claritin
C
1X / 1 DAY
54MG
(18MG&36MG
1X/1DAY)
Date:03/05/01ISR Number: 3679194-1Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 133
Company Report #10222
PT
Report Source
Product
Role
Manufacturer
Drug Ineffective
Company
Representative
Concerta
Miralax
PS
C
Alza Corp
Duration
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/05/01ISR Number: 3679479-9Report Type:Periodic
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG
Company Report #7997
PT
Report Source
Product
Role
Manufacturer
Route
Dysphagia
Health
Concerta
PS
Alza Corp
ORAL
Depakote
Clonidine
Stimulants (Nos)
C
C
C
Duration
Professional
1X/1DAY, PO
Date:03/05/01ISR Number: 3679480-5Report Type:Periodic
Age:13 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18 MG
Company Report #7738
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Health
Concerta
PS
Alza Corp
ORAL
Anaphylactic Reaction
Professional
Chest Pain
Dyspnoea
Company
Representative
Route
Duration
1X/1DAY, ORAL
Date:03/05/01ISR Number: 3679481-7Report Type:Periodic
Age:42 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18 MG-9 MG
Company Report #7739
PT
Report Source
Product
Role
Manufacturer
Diarrhoea
Consumer
Concerta
PS
Alza Corp
Duration
Headache
1X/1 DAY
Tachycardia
Vomiting
Date:03/05/01ISR Number: 3679482-9Report Type:Periodic
Age:13 YR
Gender:Male
I/FU:I
Company Report #7740
Outcome
Dose
Other
18 MG 1X/1
PT
Report Source
Product
Role
Manufacturer
Route
Skin Atrophy
Consumer
Concerta
PS
Alza Corp
ORAL
Wellbutrin Sr
C
Route
Duration
DAY, ORAL
Date:03/05/01ISR Number: 3679483-0Report Type:Periodic
Age:13 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18-36 MG PO
Company Report #7748
PT
Report Source
Product
Role
Manufacturer
Condition Aggravated
Health
Concerta
PS
Alza Corp
Gait Disturbance
Professional
Duration
1X/1 DAY
Tremor
Date:03/05/01ISR Number: 3679484-2Report Type:Periodic
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
36 MG 1X/ 1
Company Report #7749
PT
Report Source
Product
Role
Manufacturer
Route
Alopecia
Consumer
Concerta
PS
Alza Corp
ORAL
Adderall
SS
Prozac
C
Duration
DAY, ORAL
DOSE/FREQUENC
Y
18-Aug-2005
Page: 134
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/05/01ISR Number: 3679485-4Report Type:Periodic
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG 1X/1
Company Report #7750
PT
Report Source
Product
Role
Manufacturer
Route
Chest Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Dyspnoea
Health
Nervousness
Vasodilatation
Professional
Route
Duration
DAY, ORAL
Date:03/05/01ISR Number: 3679486-6Report Type:Periodic
Age:6 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18-36 MG PO
Company Report #7751
PT
Report Source
Product
Role
Manufacturer
Vision Blurred
Consumer
Concerta
PS
Alza Corp
Duration
1X/1 DAY
Date:03/05/01ISR Number: 3679487-8Report Type:Periodic
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG 1X/1
Company Report #7752
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Anorexia
Health
Chest Pain
Headache
Professional
Duration
DAY, ORAL
Date:03/05/01ISR Number: 3679488-XReport Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36MG 1X/1
Company Report #7766
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
Hostility
DAY, ORAL
Nervousness
Remeron
Date:03/05/01ISR Number: 3679489-1Report Type:Periodic
Age:46 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG 1X/DAY
C
Company Report #7770
PT
Report Source
Product
Role
Manufacturer
Route
Back Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
Hypertonia
ORAL
Date:03/05/01ISR Number: 3679490-8Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #7771
PT
Report Source
Product
Role
Manufacturer
Route
Anorexia
Consumer
Concerta
PS
Alza Corp
ORAL
Calcium
Vitamin D
C
C
Condition Aggravated
ORAL
Headache
Insomnia
Date:03/05/01ISR Number: 3679491-XReport Type:Periodic
Age:21 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18 - 54 MG PO
Company Report #7772
PT
Report Source
Product
Role
Manufacturer
Route
Rectal Haemorrhage
Health
Concerta
PS
Alza Corp
ORAL
Aerobid
C
Professional
QD
18-Aug-2005
Page: 135
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Serevent Inhaler
Maxair
Date:03/05/01ISR Number: 3679492-1Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY
C
C
Company Report #7773
PT
Report Source
Product
Role
Manufacturer
Route
Muscle Twitching
Consumer
Concerta
PS
Alza Corp
ORAL
Singulair
Claritin
Proventil Inhaler
C
C
C
Health
ORAL
Professional
Date:03/05/01ISR Number: 3679493-3Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
10 MG 1X/1DAY
Company Report #7787
PT
Report Source
Product
Role
Manufacturer
Route
Micturition Urgency
Health
Concerta
PS
Alza Corp
ORAL
Pollakiuria
Professional
ORAL
Urinary Incontinence
Date:03/05/01ISR Number: 3679494-5Report Type:Periodic
Age:17 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY
Company Report #7788
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Dyspepsia
Health
Flatulence
Professional
ORAL
Date:03/05/01ISR Number: 3679495-7Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG
Company Report #7789
PT
Report Source
Product
Role
Manufacturer
Route
Arrhythmia
Consumer
Concerta
PS
Alza Corp
ORAL
Paxil
C
Route
Duration
Hypertonia
1X/1DAY/ORAL
Pharyngitis
Date:03/05/01ISR Number: 3679496-9Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
54 MG QD > 72
Company Report #7790
PT
Report Source
Product
Role
Manufacturer
Drug Ineffective
Consumer
Concerta
PS
Alza Corp
MG QD
Date:03/05/01ISR Number: 3679497-0Report Type:Periodic
Age:49 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
36 MG 1X/1DAY
Company Report #7791
PT
Report Source
Product
Role
Manufacturer
Route
Anxiety
Consumer
Concerta
PS
Alza Corp
ORAL
Celebrex
Glucophage
Actos
C
C
C
Health
ORAL
Professional
18-Aug-2005
Page: 136
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/05/01ISR Number: 3679498-2Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG 1X/1
Company Report #7792
PT
Report Source
Product
Role
Manufacturer
Route
Dyskinesia
Health
Concerta
PS
Alza Corp
ORAL
Duration
Professional
DAY ORAL
Company
Representative
Date:03/05/01ISR Number: 3679499-4Report Type:Periodic
Age:14 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #7793
PT
Report Source
Product
Role
Manufacturer
Route
Emotional Disorder
Health
Concerta
PS
Alza Corp
ORAL
Nervousness
Professional
ORAL
Date:03/05/01ISR Number: 3679500-8Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #7801
PT
Report Source
Product
Role
Manufacturer
Route
Depression
Consumer
Concerta
PS
Alza Corp
ORAL
Thinking Abnormal
Health
Concerta (Oros
Methylphenidate
Hydrochloride)
SS
ORAL
Professional
1/2 18MG TAB
1X/1DAY
Date:03/05/01ISR Number: 3679501-XReport Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Company Report #7802
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
PT
Report Source
Product
Role
Manufacturer
Route
Pruritus
Consumer
Concerta
PS
Alza Corp
ORAL
Paxil
C
Skin Odour Abnormal
ORAL
Date:03/05/01ISR Number: 3679502-1Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #7814
PT
Report Source
Product
Role
Manufacturer
Route
Cough
Consumer
Concerta
PS
Alza Corp
ORAL
Gastrointestinal Disorder
Health
Vomiting
Professional
Route
ORAL
Date:03/05/01ISR Number: 3679503-3Report Type:Periodic
Age:34 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
DOSE AND
Company Report #7815
PT
Report Source
Product
Role
Manufacturer
Respiratory Disorder
Consumer
Concerta
PS
Alza Corp
Wellburtin
C
Duration
FREQUENCY UNK
18-Aug-2005
Page: 137
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/05/01ISR Number: 3679504-5Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG-36MG-54M
Company Report #7819
PT
Report Source
Product
Role
Manufacturer
Emotional Disorder
Consumer
Concerta
PS
Alza Corp
Route
Headache
G 1X/1DAY
Date:03/05/01ISR Number: 3679505-7Report Type:Periodic
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG
Company Report #7823
PT
Report Source
Product
Role
Manufacturer
Route
Convulsion
Consumer
Concerta
PS
Alza Corp
ORAL
Headache
Health
Route
Duration
1X/1DAY, ORAL
Professional
Date:03/05/01ISR Number: 3679506-9Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG/QD>36MG
Company Report #7833
PT
Report Source
Product
Role
Manufacturer
Headache
Consumer
Concerta
PS
Alza Corp
Catapres
Tegretol
C
C
Hypertension
QAM &
18MG@2PM
Date:03/05/01ISR Number: 3679507-0Report Type:Periodic
Age:37 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Duration
Company Report #7834
Report Source
Product
Role
Manufacturer
Route
Other
72MG
Overdose
Consumer
Concerta
PS
Ritalin
SS
Creon 10
Librax
C
C
Alza Corp
ORAL
Vision Blurred
1X/1DAY,ORAL
ORAL
20MG 4X/1DAY,
PO
Date:03/05/01ISR Number: 3679508-2Report Type:Periodic
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #7840
PT
Report Source
Product
Role
Manufacturer
Route
Abnormal Dreams
Health
Concerta
PS
Alza Corp
ORAL
Hallucination
Professional
Clonidine
C
ORAL
Date:03/05/01ISR Number: 3679509-4Report Type:Periodic
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18 MG @ 7AM
Company Report #7843
PT
Report Source
Product
Role
Manufacturer
Route
Headache
Consumer
Concerta
PS
Alza Corp
ORAL
Insulin
Rhinocort
C
C
Duration
PO 5X/WK M-F
18-Aug-2005
Page: 138
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/05/01ISR Number: 3679510-0Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18 MG 1 X / 1
Company Report #7844
PT
Report Source
Product
Role
Manufacturer
Route
Insomnia
Consumer
Concerta
PS
Alza Corp
ORAL
DAY, ORAL
Date:03/05/01ISR Number: 3679511-2Report Type:Periodic
Age:48 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
36 MG 1X /
Company Report #7909
PT
Report Source
Product
Role
Manufacturer
Route
Coordination Abnormal
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
Dizziness
1D, ORAL
Thinking Abnormal
Date:03/05/01ISR Number: 3679512-4Report Type:Periodic
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36 MG 1X / 1
Company Report #7911
PT
Report Source
Product
Role
Manufacturer
Route
Face Oedema
Consumer
Concerta
PS
Alza Corp
ORAL
Pruritus
Health
Tongue Oedema
Urticaria
Professional
Concerta (Oros
Methylphenidate
Hydrochloride)
SS
Concerta (Oros
Methylphenidate
Hydrochloride)
SS
DAY, ORAL
2 TO 3 18 MG
TABS 1X / 1
DAY
18 MG 1X / 1
ORAL
DAY, PO
Nortriptyline
Date:03/05/01ISR Number: 3679513-6Report Type:Periodic
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
C
Company Report #7912
PT
Report Source
Product
Role
Manufacturer
Drug Ineffective
Consumer
Concerta
PS
Alza Corp
Route
Duration
Date:03/05/01ISR Number: 3679514-8Report Type:Periodic
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
18 MG 1X / 1
Company Report #7916
PT
Report Source
Product
Role
Manufacturer
Route
Asthenia
Consumer
Concerta
PS
Alza Corp
ORAL
Chest Pain
Company
Ear Pain
Tinnitus
Vertigo
Representative
DAY, ORAL
Date:03/05/01ISR Number: 3679515-XReport Type:Periodic
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
36 MG 1XC/ 1
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Cough
DAY, ORAL
Headache
Pharyngitis
18-Aug-2005
Page: 139
11:49 AM
Company Report #7917
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/05/01ISR Number: 3679516-1Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18 MG 1X / 1
Company Report #7928
PT
Report Source
Product
Role
Manufacturer
Route
Muscle Twitching
Consumer
Concerta
PS
Alza Corp
ORAL
Health
DAY,
PO
Professional
Date:03/05/01ISR Number: 3679517-3Report Type:Periodic
Age:16 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18 MG 1X /
Company Report #7929
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Concerta (Oros
Methylphenidate
Hydrochloride)
SS
Paxil
C
Duration
Anorexia
1DAY, PO
Diarrhoea
Flatulence
Headache
ORAL
36 MG 1X /
Weight Decreased
1DAY, ORAL
Date:03/05/01ISR Number: 3679518-5Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG 1X /1
Company Report #7939
PT
Report Source
Product
Role
Manufacturer
Route
Dermatitis
Consumer
Concerta
PS
Alza Corp
ORAL
Concerta (Oros
Methylphenidate
Hydrochloride)
SS
Duration
Hypersensitivity
DAY, PO
Osteoarthritis
18 MG 1X/ 1
DAY, ORAL
ORAL
Prozac
Date:03/05/01ISR Number: 3679813-XReport Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Other
C
Company Report #10237
PT
Report Source
Product
Role
Manufacturer
Epistaxis
Headache
Hypertension
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Alza Corp
Date:03/05/01ISR Number: 3679815-3Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization 1/2 TAB PO
Initial or Prolonged
X1/DAY
Other
Outcome
Dose
Duration
Other
18MG-36MG PO
Company Report #7671
PT
Report Source
Product
Role
Manufacturer
Depersonalisation
Health
Concerta
PS
Alza Corp
Headache
Professional
Nausea
Company
Representative
Date:03/05/01ISR Number: 3679817-7Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:F
11:49 AM
Route
Company Report #7684
PT
Report Source
Product
Role
Manufacturer
Route
Hallucination
Health
Concerta
PS
Alza Corp
ORAL
Migraine
Professional
Visual Disturbance
Company
Representative
Zyrtec
C
1X/1 DAY
18-Aug-2005
Page: 140
Route
Duration
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/05/01ISR Number: 3679820-7Report Type:Periodic
Age:18 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Other
54MG 1X/1DAY
Company Report #7706
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Consumer
Concerta
PS
Alza Corp
ORAL
Confusional State
Health
Insomnia
Speech Disorder
Professional
Wellbutrin
C
, ORAL
Date:03/05/01ISR Number: 3679823-2Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
18MG 1X /1
Company Report #7711
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Health
Concerta
PS
Alza Corp
ORAL
Face Oedema
Professional
Headache
Laryngeal Oedema
Palpitations
Pruritus
Urticaria
Company
Representative
Route
Duration
DAY ORAL
Date:03/05/01ISR Number: 3680459-8Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG-72MG PO
Company Report #10024
PT
Report Source
Product
Role
Manufacturer
Anorexia
Consumer
Concerta
PS
Alza Corp
Asthenia
1X/1 DAY
Insomnia
Date:03/05/01ISR Number: 3680460-4Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Company Report #10036
Outcome
Dose
Other
54 MG 1X/1
PT
Report Source
Product
Role
Manufacturer
Route
Paraesthesia
Consumer
Concerta
PS
Alza Corp
ORAL
Concerta (Oros
Methylphenidate
Hydrochloride)
SS
Duration
Health
DAY, ORAL
Professional
18 MG TO 36
MG 1X/1DAY
Date:03/05/01ISR Number: 3680461-6Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG 1X/1
Company Report #10039
PT
Report Source
Product
Role
Manufacturer
Route
Headache
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
DAY, ORAL
Date:03/05/01ISR Number: 3680466-5Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18 MG 1X/1DAY
Company Report #10045
PT
Report Source
Product
Role
Manufacturer
Route
Dermatitis
Consumer
Concerta
PS
Alza Corp
ORAL
Face Oedema
Health
Allergy Shots (Nos)
C
, ORAL
Professional
18-Aug-2005
Page: 141
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/05/01ISR Number: 3680471-9Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG 1X/ 1
Company Report #10046
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
DAY, ORAL
Date:03/05/01ISR Number: 3680472-0Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG 1X/1
Company Report #10047
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Consumer
Concerta
PS
Alza Corp
ORAL
Concerta (Oros
Methylphenidate
Hydrochloride)
SS
Duration
DAY, ORAL
ORAL
18 MG, 1X/1
DAY, ORAL
Date:03/05/01ISR Number: 3680473-2Report Type:Periodic
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18 MG 1X/1
Company Report #10049
PT
Report Source
Product
Role
Manufacturer
Route
Personality Disorder
Consumer
Concerta
PS
Alza Corp
ORAL
Role
Manufacturer
Route
Duration
DAY, ORAL
Date:03/05/01ISR Number: 3680474-4Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #10104
Report Source
Product
Other
36 MG 1X/1
Angioneurotic Oedema
Health
Dermatitis
Professional
Concerta
PS
Clonidine
C
Alza Corp
ORAL
DAY, ORAL
Face Oedema
Urticaria
Date:03/05/01ISR Number: 3680475-6Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG
Company Report #10105
PT
Report Source
Product
Role
Manufacturer
Route
Agitation
Consumer
Concerta
PS
Alza Corp
ORAL
Singulair
C
Duration
Anxiety
1X/1DAY, ORAL
Eye Disorder
Date:03/05/01ISR Number: 3680476-8Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG 1X/1
Company Report #10115
PT
Report Source
Product
Role
Manufacturer
Route
Vomiting
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
DAY, ORAL
Date:03/05/01ISR Number: 3681337-0Report Type:Periodic
Age:17 YR
Gender:Female
I/FU:I
Outcome
Other
18-Aug-2005
Page: 142
PT
Chills
Face Oedema
Pruritus
11:49 AM
Company Report #7942
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Urticaria
Dose
Report Source
Product
Role
Manufacturer
Route
Consumer
Concerta
PS
Alza Corp
ORAL
Tylenol
C
Duration
35 MG 1X/1
DAY, ORAL
Date:03/05/01ISR Number: 3681338-2Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG
Company Report #7975
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Consumer
Concerta
PS
Alza Corp
ORAL
Manufacturer
Route
Duration
Insomnia
1X/1DAY, ORAL
Date:03/05/01ISR Number: 3681339-4Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #7979
PT
Report Source
Product
Role
Headache
Health
Professional
Concerta (Oros
Methylphenidate
Hydrochloride)
PS
Duration
ORAL
36 MG
1X/1DAY, ORAL
Date:03/05/01ISR Number: 3681340-0Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36 MG 1X/DAY,
PT
Report Source
Product
Role
Manufacturer
Route
Dizziness
Consumer
Concerta
PS
Alza Corp
ORAL
Headache
ORAL
Company Report #7985
Vomiting
Paxil
Date:03/05/01ISR Number: 3681341-2Report Type:Periodic
Age:15 YR
Gender:Not SpecifiI/FU:I
Outcome
Dose
Other
1-18 MG TAB
C
Company Report #7986
PT
Report Source
Product
Role
Manufacturer
Agitation
Consumer
Concerta
PS
Alza Corp
Concerta (Oros
Methylphenidate
Hydrochloride)
SS
Zoloft
C
Route
Duration
Anxiety
1X/DAY
Hyperhidrosis
Nervousness
ORAL
18 MG
1X/1DAY, PO
Date:03/05/01ISR Number: 3681342-4Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG TAB
PT
Report Source
Product
Role
Manufacturer
Agitation
Consumer
Concerta
PS
Alza Corp
Duration
Anxiety
1X/1DAY
Hostility
18-Aug-2005
Page: 143
Company Report #7987
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/05/01ISR Number: 3681343-6Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG
Company Report #7989
PT
Report Source
Product
Role
Manufacturer
Route
Anorexia
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
Arrhythmia
1X/1DAY, ORAL
Constipation
Dyspnoea
Date:03/05/01ISR Number: 3681344-8Report Type:Periodic
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18 - 36 MG PO
Company Report #7990
PT
Report Source
Product
Role
Manufacturer
Route
Nausea
Consumer
Concerta
PS
Alza Corp
ORAL
Serevent
Singulair
Proventil
C
C
C
Overdose
1X/1DAY
Tachycardia
Vasodilatation
Date:03/05/01ISR Number: 3681345-XReport Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
54 MG 1X/DAY,
Company Report #7991
PT
Report Source
Product
Role
Manufacturer
Route
Paraesthesia
Consumer
Concerta
PS
Alza Corp
ORAL
Role
Manufacturer
Route
Pruritus
ORAL
Date:03/05/01ISR Number: 3681346-1Report Type:Periodic
Age:34 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #7992
Report Source
Product
Other
36MG TAB-1
Constipation
Consumer
Concerta
PS
Concerta (Oros
Methylphenidate
Hydrochloride)
SS
Alza Corp
Drug Ineffective
1/21X/1DAY
Gastrointestinal Disorder
Tremor
ORAL
36MG 1X/1DAY,
PO
Date:03/05/01ISR Number: 3681358-8Report Type:Periodic
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
36MG 1X/1
Company Report #7996
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Allegra
C
Route
Duration
Health
DAY, ORAL
Professional
Date:03/05/01ISR Number: 3681359-XReport Type:Periodic
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
1TAB1X/1DAY-2
PT
Report Source
Product
Role
Manufacturer
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
Anorexia
TAB1X/1DAY
Depression
Insomnia
Weight Decreased
18-Aug-2005
Page: 144
11:49 AM
Company Report #7998
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/05/01ISR Number: 3681360-6Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG
Company Report #7999
PT
Report Source
Product
Role
Manufacturer
Route
Anaphylactic Reaction
Health
Concerta
PS
Alza Corp
ORAL
Dermatitis
Professional
Dyspnoea
Face Oedema
Company
Representative
Concerta (Oros
Methylphenidate
Hydrochloride)
SS
Duration
1X/1DAY, PO
ORAL
18MG 1X/1DAY,
ORAL
Date:03/05/01ISR Number: 3681361-8Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG - 72 MG
Company Report #10001
PT
Report Source
Product
Role
Manufacturer
Halitosis
Consumer
Concerta
PS
Alza Corp
Route
Stomatitis
1X/1DAY
Date:03/05/01ISR Number: 3681362-XReport Type:Periodic
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG - 54MG
Company Report #10002
PT
Report Source
Product
Role
Manufacturer
Route
Agitation
Consumer
Concerta
PS
Alza Corp
ORAL
Role
Manufacturer
Route
Duration
Hostility
PO 1X/1 DAY
Date:03/05/01ISR Number: 3681363-1Report Type:Periodic
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Duration
Company Report #10014
Report Source
Product
Other
36MG TO 18MG
Anorexia
Consumer
Concerta
PS
Alza Corp
Insomnia
1X/1 DAY
Pain In Extremity
Sedation
Date:03/05/01ISR Number: 3681364-3Report Type:Periodic
Age:17 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
18MG - 36 MG
Company Report #10015
PT
Report Source
Product
Role
Manufacturer
Dermatitis
Consumer
Concerta
PS
Alza Corp
Benzamycin
C
Route
Headache
QD
Muscle Twitching
Skin Discolouration
Date:03/05/01ISR Number: 3681365-5Report Type:Periodic
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
54MG 1X/1DAY,
PT
Report Source
Product
Role
Manufacturer
Route
Cough
Consumer
Concerta
PS
Alza Corp
ORAL
Sinusitis
ORAL
Upper Respiratory Tract
Infection
18-Aug-2005
Page: 145
11:49 AM
Company Report #10016
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/05/01ISR Number: 3681366-7Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
72MG TO 36 MG
Company Report #10017
PT
Report Source
Product
Role
Manufacturer
Route
Anorexia
Consumer
Concerta
PS
Alza Corp
ORAL
Imipramine
Clonidine
C
C
Dyspepsia
PO 1X/1DAY
Date:03/05/01ISR Number: 3681367-9Report Type:Periodic
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #10023
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Anorexia
ORAL
Emotional Disorder
Date:03/12/01ISR Number: 3681651-9Report Type:Expedited (15-DaCompany Report #PHBS2001AR02330
Age:15 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
10 MG ONCE
PT
Report Source
Product
Role
Manufacturer
Route
Blood Pressure Increased
Body Temperature
Foreign
Literature
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Increased
Health
Circulatory Collapse
Cyanosis
Hallucination, Visual
Heart Rate Decreased
Medication Error
Respiratory Depression
Professional
Other
ORAL
Date:03/14/01ISR Number: 3680933-4Report Type:Expedited (15-DaCompany Report #PHEH2001US02106
Age:
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Abnormal Behaviour
Anxiety
Consumer
Ritalin
PS
Novartis
Pharmaceuticals Corp
Prozac (Fluoxetine
Hydrochloride)
SS
Route
Duration
2555 DAY
Completed Suicide
Depression
2555 DAY
Drug Dependence
Personality Change
Date:03/14/01ISR Number: 3680974-7Report Type:Expedited (15-DaCompany Report #PHEH2001US02103
Age:17 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
55 MG QAM, 15
PT
Report Source
Product
Role
Manufacturer
Route
Headache
Hypoaesthesia
Health
Professional
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Loss Of Consciousness
MG Q PM, ORAL
Date:03/14/01ISR Number: 3681714-8Report Type:Expedited (15-DaCompany Report #PHNU2001DE00642
Age:9 YR
Gender:Female
I/FU:F
Outcome
Hospitalization Initial or Prolonged
Other
18-Aug-2005
Page: 146
11:49 AM
PT
Drug Ineffective
Haematoma
Idiopathic
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Thrombocytopenic Purpura
Dose
Report Source
Product
Role
Manufacturer
Route
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
20MG/DAY,
Professional
ORAL
Other
Ritalin-Sr(Methylphe
nidate
Hydrochloride)Slow
Release Tablet, 20mg
SS
Zyrtec (Cetirizine
Hydrochloride)
C
ORAL
20 MG, QD,
ORAL
Date:03/19/01ISR Number: 3683421-4Report Type:Direct
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #USP 53796
Report Source
Product
Role
Manufacturer
Metadate Er
Methadone
Hydrochloride
PS
Medava
Route
Duration
Medication Error
SS
Date:03/20/01ISR Number: 3685655-1Report Type:Expedited (15-DaCompany Report #10405
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 18 MG 1X/1
Initial or Prolonged
DAY, ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Convulsion
Health
Concerta
PS
Alza Corp
ORAL
Drug Interaction
Professional
Wellbutrin
SS
Doxycycline
Acne Cream
C
C
Other
450 MG 1X/1
DAY, PO
ORAL
Date:03/20/01ISR Number: 3685775-1Report Type:Expedited (15-DaCompany Report #001-0073-M0100130
Age:20 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PER ORAL
Other
PT
Report Source
Product
Role
Manufacturer
Route
Blood Albumin Decreased
Convulsion
Consumer
Dilantin
PS
Parke Davis Div
Warner Lambert Co
ORAL
Drug Interaction
Drug Level Below
Therapeutic
Hypoventilation
Pneumonia
Sinusitis
Status Epilepticus
Urinary Tract Infection
Methylphenidate
(Methylphenidate)
Hydrocortisone
(Hydrocortisone)
Testosterone
(Testosterone)
Levothyroxine
(Levothyroxine)
SS
SS
SS
SS
Date:03/27/01ISR Number: 3690489-8Report Type:Expedited (15-DaCompany Report #10397
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36MG 1X/1
PT
Report Source
Product
Role
Manufacturer
Route
Hallucination, Auditory
Consumer
Concerta
PS
Alza Corp
ORAL
Concerta
(Methylphenidate
Hc1)
SS
Duration
DAY, ORAL
18MG 1X/1DAY,
18-Aug-2005
Page: 147
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
ORAL
Date:03/27/01ISR Number: 3690491-6Report Type:Expedited (15-DaCompany Report #10438
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
54 (>THAN 10
PT
Report Source
Product
Role
Manufacturer
Medication Error
Health
Concerta
PS
Alza Corp
Product
Role
Manufacturer
Route
Methylphenidate
PS
Route
Route
Professional
PILLS)
Date:03/27/01ISR Number: 3690649-6Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #
Report Source
Duration
Abnormal Behaviour
Aggression
Anger
Anxiety
Date:03/28/01ISR Number: 3691922-8Report Type:Expedited (15-DaCompany Report #10451
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 36 MG QAM +
Initial or Prolonged
18 MG Q NOON
PT
Report Source
Product
Role
Manufacturer
Aggression
Health
Concerta
PS
Alza Corp
Agitation
Professional
Risperdal
Clonidine
Albuterol
Dexedrine
C
C
C
C
Irritability
Date:03/28/01ISR Number: 3691925-3Report Type:Expedited (15-DaCompany Report #10449
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 54 MG 1
Initial or Prolonged
X/1DAY, ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Abnormal Behaviour
Health
Concerta
PS
Alza Corp
ORAL
Aggression
Professional
Zyprexa
Depakote Er
C
C
Route
Date:03/29/01ISR Number: 3692637-2Report Type:Expedited (15-DaCompany Report #10456
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 108 MG 1X 1
Initial or Prolonged
DAY
PT
Report Source
Product
Role
Manufacturer
Abnormal Behaviour
Health
Concerta
PS
Alza Corp
Anxiety
Professional
Wellbutrin
Dexedrine
Desyrel
Methylin
C
C
C
C
Dysarthria
Grunting
Lethargy
Respiratory Rate
Increased
Date:04/02/01ISR Number: 3694653-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB01061
Age:12 YR
Gender:Male
I/FU:I
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 148
11:49 AM
PT
Allergic Granulomatous
Angiitis
Report Source
Foreign
Health
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Professional
Other
Dose
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
25 MG/D, ORAL
Beclometasone
Ventolin
C
C
Date:04/02/01ISR Number: 3694683-1Report Type:Expedited (15-DaCompany Report #PHNU2001DE004778
Age:7 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Manufacturer
Route
Cardiomegaly
Pulmonary Hypertension
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
1-0.5, ORAL
Professional
Date:04/03/01ISR Number: 3695478-5Report Type:Expedited (15-DaCompany Report #10502
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
54MG
PT
Report Source
Product
Role
Manufacturer
Route
Overdose
Health
Concerta
PS
Alza Corp
ORAL
Route
Duration
Professional
1X/1DAY,ORAL
Date:04/05/01ISR Number: 3698250-5Report Type:Expedited (15-DaCompany Report #10503
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36-54MG 1 X /
PT
Report Source
Product
Role
Manufacturer
Abdominal Pain Upper
Consumer
Concerta
PS
Alza Corp
Blood Bilirubin Increased
1 DAY
Diarrhoea
Hepatitis B Surface
Antigen Positive
Jaundice
Ph Urine Increased
Vomiting
White Blood Cells Urine
Positive
Date:04/06/01ISR Number: 3700272-2Report Type:Expedited (15-DaCompany Report #MPU-2001-00156 (0)
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
25MG DAILY
PT
Report Source
Product
Role
Manufacturer
Allergic Granulomatous
Angiitis
Foreign
Methylphenidate Hcl
PS
Md Pharmaceutical
Inc
Beclomethasone
Dipropionate
Ventolin
(Salbutamol)
Date:04/12/01ISR Number: 3704071-7Report Type:Expedited (15-DaCompany Report #10449
Age:15 YR
Gender:Male
I/FU:F
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 149
11:49 AM
PT
Abnormal Behaviour
Aggression
Agitation
C
C
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Irritability
Dose
Report Source
Product
Role
Manufacturer
Route
Health
Concerta
PS
Alza Corp
ORAL
Zyprexa
Depakote Er
C
C
Route
Duration
54MG 1X/1DAY,
Professional
ORAL
Date:04/12/01ISR Number: 3704072-9Report Type:Expedited (15-DaCompany Report #10451
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization 36 MG GAM +
Initial or Prolonged
18MG Q NOON
PT
Report Source
Product
Role
Manufacturer
Aggression
Health
Concerta
PS
Alza Corp
Agitation
Professional
Risperdal
Clonidine
Albuterol
Dexedrine
Theophyl-Sr
C
C
C
C
C
Irritability
Date:04/13/01ISR Number: 3704415-6Report Type:Direct
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
5 MG & X3
Hospitalization 0.25MQ0.10
Initial or Prolonged
X1X1
Disability
Required
Intervention to
Prevent Permanent
Impairment/Damage
PT
Company Report #
Product
Role
Aggression
Ritalin 5 Mg&10 Mg
PS
Catatonia
Clonidine 0.5 Mg
SS
Depression
Dry Mouth
Growth Retardation
Headache
Keratoconjunctivitis
Sicca
Mania
Report Source
Manufacturer
Route
Mood Swings
Palpitations
Psychomotor Hyperactivity
Pyrexia
Sleep Disorder
Vision Blurred
Weight Gain Poor
Date:04/13/01ISR Number: 3705111-1Report Type:Expedited (15-DaCompany Report #10597
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 54MG (36MG +
Initial or Prolonged
18MG) 1X/DAY
PT
Report Source
Product
Role
Manufacturer
Abnormal Behaviour
Health
Concerta
PS
Alza Corp
Aggression
Professional
Route
Anxiety
Date:04/16/01ISR Number: 3705953-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB01248
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 150
PT
Report Source
Product
Role
Manufacturer
Papilloedema
Foreign
Health
Professional
Other
Ritalin
PS
Novartis
Pharmaceuticals Corp
Duration
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/16/01ISR Number: 3706159-3Report Type:Expedited (15-DaCompany Report #PHBS2001JP00910
Age:3 DY
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Complications Of Maternal
Exposure To Therapeutic
TRANSPLACENTA
Drugs
Foreign
Health
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
Convulsion Neonatal
Dyskinesia
Jaundice Neonatal
TRANSPLACENTA
Other
Anafranil(Clomiprami
ne Hydrochloride)
Tablet
SS
Wintermin(Chlorproma
zine Hydrochloride)
SS
Serenace(Haloperidol
)
SS
Contomin(Chlorpromaz
ine
SS
Artane
(Trihexyphenidyl
Hydrochloride)
SS
Route
Duration
TRANSPLACENTAL
Professional
L
TRANSPLACENTAL
L
TRANSPLACENTAL
TRANSPLACENTA
L
TRANSPLACENTAL
TRANSPLACENTA
L
TRANSPLACENTAL
TRANSPLACENTA
L
TRANSPLACENTAL
TRANSPLACENTA
L
Date:04/17/01ISR Number: 3707365-4Report Type:Expedited (15-DaCompany Report #10600
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36 MG 1X/1DAY
PT
Report Source
Product
Role
Manufacturer
Dyssomnia
Consumer
Concerta
PS
Alza Corp
Route
Concerta
(Methylphenidate
Hcl)
SS
Prozac
C
ORAL
18 MG
1X/1DAY, ORAL
Date:04/19/01ISR Number: 3708275-9Report Type:Expedited (15-DaCompany Report #10585
Age:7 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 151
PT
Report Source
Product
Role
Manufacturer
Abdominal Pain
Agitation
Arthralgia
Decreased Appetite
Dysarthria
Dyskinesia
Headache
Heart Rate Increased
Hyperhidrosis
Muscle Twitching
Nervousness
Palpitations
Pruritus
Pulse Pressure Increased
Tremor
Vision Blurred
Visual Disturbance
Consumer
Concerta
PS
Alza Corp
Duration
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/19/01ISR Number: 3708276-0Report Type:Expedited (15-DaCompany Report #10502
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Death
54MG 1X/1DAY,
PT
Report Source
Product
Role
Manufacturer
Route
Abnormal Behaviour
Health
Concerta
PS
Alza Corp
ORAL
Cardiac Disorder
Professional
ORAL
Coma
Drug Level Above
Therapeutic
Hepatic Steatosis
Overdose
Pulmonary Congestion
Pulmonary Oedema
Date:04/20/01ISR Number: 3708677-0Report Type:Expedited (15-DaCompany Report #10598
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG
PT
Report Source
Product
Role
Manufacturer
Route
Anger
Health
Concerta
PS
Alza Corp
ORAL
Bipolar Disorder
Professional
Multivitamin
C
Route
Duration
1X/1DAY, ORAL
Condition Aggravated
Depressed Mood
Depression
Disturbance In Attention
Educational Problem
Feeling Abnormal
Insomnia
Nightmare
Suicidal Ideation
Thinking Abnormal
Date:04/24/01ISR Number: 3710572-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB01262
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Manufacturer
Medulloblastoma
Foreign
Ritalin
PS
Novartis
Health
Pharmaceuticals Corp
ORAL
ORAL
Professional
Other
Date:04/30/01ISR Number: 3715284-2Report Type:Expedited (15-DaCompany Report #PHNU2000DE02259
Age:44 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Manufacturer
Route
Cardiomegaly
Cerebral Ischaemia
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Coma
Professional
Congestive Cardiomyopathy
Dyspnoea
Heart Rate Increased
Hyperhidrosis
Hypoxia
Ventricular Fibrillation
Other
2 DF, TID,
ORAL
18-Aug-2005
Page: 152
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/30/01ISR Number: 3715288-XReport Type:Expedited (15-DaCompany Report #PHBS2001CA03983
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Manufacturer
Route
Anorexia
Weight Decreased
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Route
Duration
ORAL
Professional
Other
Date:05/02/01ISR Number: 3715637-2Report Type:Expedited (15-DaCompany Report #10597
Age:16 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization 54MG (36MG +
Initial or Prolonged
18MG) 1X/1DAY
PT
Report Source
Product
Role
Manufacturer
Abnormal Behaviour
Health
Concerta
PS
Alza Corp
Aggression
Professional
Blood Alkaline
Phosphatase Increased
Date:05/02/01ISR Number: 3715640-2Report Type:Expedited (15-DaCompany Report #10646
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG
PT
Report Source
Product
Role
Manufacturer
Route
Hepatitis C
Health
Concerta
PS
Alza Corp
ORAL
Platelet Count Decreased
Professional
Haldol
Tenex
Depakote
C
C
C
Manufacturer
Route
Duration
1X1/DAY, ORAL
Other
Date:05/02/01ISR Number: 3715753-5Report Type:Expedited (15-DaCompany Report #MPI-2001-05038(0)
Age:
Gender:Female
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Hospitalization Initial or Prolonged
90MG DAILY
Obsessive-Compulsive
Disorder
Foreign
Literature
Methylphenidate Hcl
Theft
Health
Professional
Sertraline
(Sertraline)
Clonidine
(Clonidine)
PS
Md Pharmaceutical
Inc
C
C
Date:05/03/01ISR Number: 3717120-7Report Type:Expedited (15-DaCompany Report #PHNU2000DE01232
Age:
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Chest Pain
Cyanosis
Foreign
Health
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Professional
Other
Date:05/03/01ISR Number: 3717369-3Report Type:Expedited (15-DaCompany Report #10502
Age:13 YR
Gender:Male
I/FU:F
Outcome
Death
18-Aug-2005
Page: 153
PT
Bicuspid Aortic Valve
Cardiomegaly
Coma
Drug Toxicity
Hepatic Steatosis
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Overdose
Pulmonary Congestion
Pulmonary Oedema
Dose
Report Source
Product
Role
Manufacturer
Route
Health
Concerta
PS
Alza Corp
ORAL
Wellbutrin
C
Route
Duration
54MG 1X/1DAY,
Professional
ORAL
Date:05/07/01ISR Number: 3718237-3Report Type:Expedited (15-DaCompany Report #MPI-2001-05047 (0)
Age:15 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
10 MG ONCE
Required
Intervention to
Prevent Permanent
Impairment/Damage
PT
Report Source
Product
Role
Manufacturer
Blood Pressure Increased
Body Temperature
Foreign
Literature
Methylphenidate Hcl
PS
Md Pharmaceutical
Inc
Increased
Circulatory Collapse
Cyanosis
Hallucination, Visual
Pulse Absent
Respiratory Arrest
Health
Professional
Date:05/07/01ISR Number: 3718639-5Report Type:Expedited (15-DaCompany Report #10723
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 18 MG 1X/1DAY
Initial or Prolonged
ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Headache
Health
Concerta
PS
Alza Corp
ORAL
Lethargy
Professional
Zoloft
Clonidine
C
C
Pyrexia
Sinusitis
Tachycardia
Date:05/08/01ISR Number: 3718338-XReport Type:Expedited (15-DaCompany Report #259738
Age:44 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Life-Threatening
8
DAY
11
18
PT
Report Source
Product
Role
Manufacturer
Anaemia
Trimethoprim
PS
Roche
Leukopenia
Ritalin
SS
Purpura
Thrombocytopenia
Lansoprazole
Lorazepam
Citalopram
C
C
C
Dexamethasone
C
Co-Danthramer
C
Atenolol
C
Diamorphine
C
Metoclopramide
C
Haloperidol
C
Magnesium
C
Route
DAY
DAY
DOSE
VARIABLE.
8
DAY
7
DAY
VARIABLE
DOSE.
29
DAY
67
DAY
67
DAY
36
DAY
Date:05/08/01ISR Number: 3718816-3Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Duration
Other
1 PO X 1 ONLY
PT
Product
Role
Aggression
Claritin Reditab
PS
Muscle Twitching
Ritalin
SS
7MG BID
Psychotic Disorder
Self Mutilation
18-Aug-2005
Page: 154
11:49 AM
Company Report #
Report Source
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/08/01ISR Number: 3719318-0Report Type:Expedited (15-DaCompany Report #PHBS2000AU08649
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
10 MG/DAY,
PT
Report Source
Product
Role
Manufacturer
Route
Aplastic Anaemia
Foreign
Health
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Route
Professional
ORAL
Other
Date:05/08/01ISR Number: 3719700-1Report Type:Expedited (15-DaCompany Report #10503
Age:16 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
36-54MG
PT
Report Source
Product
Role
Manufacturer
Abdominal Pain Upper
Consumer
Concerta
PS
Alza Corp
Blood Bilirubin Increased
Health
Diarrhoea
Hepatitis B Surface
Antigen Positive
Jaundice
Nausea
Ph Urine Increased
Urine Analysis Abnormal
Vomiting
Professional
Duration
1X/1DAY
Date:05/09/01ISR Number: 3720421-XReport Type:Expedited (15-DaCompany Report #10739
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
72 MG (1-36
PT
Report Source
Product
Role
Manufacturer
Condition Aggravated
Literature
Concerta
PS
Alza Corp
Nephrolithiasis
Health
Duration
MG+2-18
Professional
MG)/DAY
Route
Date:05/09/01ISR Number: 3720462-2Report Type:Expedited (15-DaCompany Report #259738
Age:44 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Manufacturer
Route
Anaemia
Folate Deficiency
Foreign
Other
Trimpex
PS
Hoffmann La Roche
Inc
ORAL
200 MG 2 PER
Leukopenia
DAY ORAL
Purpura
Serum Ferritin Increased
Thrombocytopenia
Ritalin
(Methylphenidate
Hydrochloride)
SS
15 MG 2 PER
Vitamin B12 Increased
DAY ORAL
Lansoprazole
(Lansoprazole)
Lorazepam
(Lorazepam)
Citalopram
(Citalopram)
Dexamethasone
(Dexamethasone)
Co-Danthramer
(Danthopron/Poloxame
r)
Atenolol (Atenolol)
Diamorphine
(Diacetylmorphine)
Metoclopramide
(Metoclopramide
18-Aug-2005
Page: 155
11:49 AM
C
C
C
C
C
C
C
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hydrochloride)
Haloperidol
(Haloperidol)
Magnesium (Magnesium
Nos)
C
C
C
Date:05/10/01ISR Number: 3720724-9Report Type:Expedited (15-DaCompany Report #PHEH2001US02103
Age:17 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
15 MG Q PM,
PT
Report Source
Product
Role
Manufacturer
Route
Headache
Hypoaesthesia
Health
Professional
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Loss Of Consciousness
ORAL
Visual Disturbance
Methylphenidate
(Methylphenidate
Hydrochloride ) Slow
Release Tablet
SS
40 MG, QD
Date:05/11/01ISR Number: 3722364-4Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #
Report Source
Product
Role
Manufacturer
Route
Aggression
Condition Aggravated
Concerta 18/36 Mg
Alza
PS
Alza
ORAL
Hallucination, Visual
Adderral 2.5/5 Mg
SS
Duration
CONCERTA PO
ORAL
ADDERRAL PO
Psychotic Disorder
Date:05/11/01ISR Number: 3722418-2Report Type:Expedited (15-DaCompany Report #PHNU1996DE00281
Age:14 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Life-Threatening
ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Aplastic Anaemia
Leukopenia
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Thrombocytopenia
Professional
Other
Date:05/14/01ISR Number: 3724080-1Report Type:Expedited (15-DaCompany Report #PHNU2000DE02259
Age:44 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Manufacturer
Route
Cardiomegaly
Cerebral Ischaemia
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Coma
Professional
Congestive Cardiomyopathy
Dyspnoea
Heart Rate Increased
Hyperhidrosis
Hypoxia
Ventricular Fibrillation
Other
90 MG/DAY,
ORAL
Date:05/14/01ISR Number: 3724103-XReport Type:Expedited (15-DaCompany Report #PHBS2001JP04522
Age:28 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Drug Abuser
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
NASAL
Duration
MORE THAN 100
Professional
MG, NASAL
18-Aug-2005
Page: 156
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Lexotan (Bromazepam)
Serenace
Restas
(Flutoprazepam)
C
C
C
Date:05/24/01ISR Number: 3728689-0Report Type:Expedited (15-DaCompany Report #PHNU2001DE01271
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
0.75 DF, 5QD,
PT
Report Source
Product
Role
Manufacturer
Route
Back Pain
Benign Intracranial
Foreign
Health
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
ORAL
Hypertension
Professional
Brain Oedema
Diplopia
Other
ORAL
Date:05/25/01ISR Number: 3729295-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB01248
Age:
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Papilloedema
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
ORAL
Professional
Other
Date:05/25/01ISR Number: 3730539-3Report Type:Expedited (15-DaCompany Report #PHNU2001DE01271
Age:11 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
0.75 DF, 5QD,
PT
Report Source
Product
Role
Manufacturer
Route
Back Pain
Benign Intracranial
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Hypertension
Professional
Brain Oedema
Diplopia
Other
ORAL
Jodthyrox
C
Hormone Level Abnormal
Date:05/29/01ISR Number: 3730093-6Report Type:Expedited (15-DaCompany Report #MPI-2001-05385(0)
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
90 MG, OVER
PT
Report Source
Product
Role
Manufacturer
Route
Adjustment Disorder With
Depressed Mood
Health
Professional
Metadate Er
PS
Celltech
Pharmaceuticals Inc
ORAL
Delirium
12 HRS, PO
Dysarthria
Eye Rolling
Malaise
Date:05/29/01ISR Number: 3731055-5Report Type:Periodic
Age:41 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
20 MG, QD,
Company Report #PHEH2000US09485
PT
Report Source
Product
Role
Manufacturer
Route
Blood Alkaline
Phosphatase Increased
Health
Professional
Ritalin-Sr
PS
Novartis
Pharmaceuticals Corp
ORAL
Blood Bilirubin Increased
ORAL
Liver Function Test
Abnormal
18-Aug-2005
Page: 157
11:49 AM
Claritin
(Loratadine)
St. John;S Wort
C
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
(Hypericum
Perforatum)
Kava "Ratiopharm"
(Kava-Kava Rhizoma)
Date:05/29/01ISR Number: 3731058-0Report Type:Periodic
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
C
C
Company Report #PHEH2000US09742
PT
Report Source
Product
Role
Manufacturer
Route
Arthralgia
Convulsion
Health
Professional
Methylphendate Hcl
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
30 MG, QD,
Fall
ORAL
Gaze Palsy
Methylphenidate Hcl
SS
Minocycline
Aleve
C
C
ORAL
20 MG, QD,
Headache
ORAL
Myalgia
Date:05/30/01ISR Number: 3730744-6Report Type:Expedited (15-DaCompany Report #MPU-2001-00181 (0)
Age:
Gender:Male
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Manufacturer
Cyanosis
Erythema
Foreign
Health
Methylphenidate Hcl
PS
Md Pharmaceutical
Inc
Feeling Cold
Professional
Duration
10 MG
(MORNING &
Skin Disorder
MIDDAY),
5
MG (TEATIME),
2.5 MG
Date:05/31/01ISR Number: 3731134-2Report Type:Expedited (15-DaCompany Report #261128
Age:17 YR
Gender:Male
I/FU:I
Route
Outcome
Dose
Other
34
PT
Report Source
Product
Role
Manufacturer
Accutane Capsules
Concerta
PS
SS
Roche
Route
Duration
Attention
Deficit/Hyperactivity
DAY
Disorder
Leukopenia
Thrombocytopenia
Date:06/01/01ISR Number: 3732249-5Report Type:Expedited (15-DaCompany Report #PHBS1999NO08474
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Arterial Disorder
Eye Disorder
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Migraine
Papilloedema
Professional
Other
Selo-Zok (Metoprolol
Tartrate)
Duration
ORAL
C
Date:06/01/01ISR Number: 3732259-8Report Type:Expedited (15-DaCompany Report #PHNU2000DE02274
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Electrocardiogram Qt
Prolonged
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
10MG/DAY,
Professional
ORAL
Other
18-Aug-2005
Page: 158
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/01ISR Number: 3732278-1Report Type:Expedited (15-DaCompany Report #261128
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Attention
Consumer
Accutane
PS
Hlr Technology
ORAL
Deficit/Hyperactivity
Disorder
Leukopenia
Health
Professional
Other
Concerta
(Methylphenidate
Hydrochloride)
SS
Duration
ORAL
36 MG DAILY
Thrombocytopenia
ORAL
Viral Infection
Date:06/01/01ISR Number: 3733519-7Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
Company Report #7802
PT
Report Source
Product
Role
Manufacturer
Route
Pruritus
Skin Odour Abnormal
Consumer
Health
Professional
Concerta (Oros
Methylphenidate
Hydrochloride)
PS
Alza Corp
ORAL
Paxil
C
Duration
18MG 1X /
1DAY, ORAL
ORAL
10MG 1X / 1
DAY, PO
Date:06/01/01ISR Number: 3733521-5Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Agitation
Anxiety
Confusional State
Consumer
Health
Professional
Concerta
(Methylphenidate
Hc1)
PS
Alza Corp
Duration
54 MG (3-18MG
Hostility
TAB) 1X/1D
Company Report #7987
Route
Date:06/01/01ISR Number: 3733523-9Report Type:Periodic
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
Company Report #7990
PT
Report Source
Product
Role
Manufacturer
Accidental Overdose
Asthenia
Headache
Consumer
Health
Professional
Concerta (Oros
Methylphenidate
Hydrochloride)
PS
Alza Corp
Serevent
C
Singulair
C
Proventil
C
Route
Duration
72 MG X 1
Nausea
DOSE
Tachycardia
2X / 1 DAY
Vasodilatation
PRESENT
1 X / 1 DAY
PRESENT
PRN PRESENT
Date:06/01/01ISR Number: 3733528-8Report Type:Periodic
Age:34 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
Company Report #7992
PT
Report Source
Product
Role
Manufacturer
Constipation
Drug Ineffective
Gastrointestinal Disorder
Consumer
Health
Professional
Concerta (Oros
Methylphenidate
Hydrochloride)
PS
Alza Corp
Concerta (Oros
Methylphenidate
Hydrochloride)
SS
Route
Duration
36MG TAB-1
Tremor
1/2 1X/ 1 DAY
36MG 1X / 1
DAY, PO
18-Aug-2005
Page: 159
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/01ISR Number: 3733531-8Report Type:Periodic
Age:17 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
Company Report #10015
PT
Report Source
Product
Role
Manufacturer
Dermatitis
Headache
Muscle Twitching
Consumer
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Alza Corp
Concerta
(Methylphenidate
Hcl)
SS
Benzamycin
C
Route
Duration
36MG 1X / 1
Skin Discolouration
DAY
Tremor
ORAL
18MG 1X / 1
DAY, ORAL
TOPICAL
USE TOPICALLY
BID PRESENT
Date:06/01/01ISR Number: 3733534-3Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
Company Report #10045
PT
Report Source
Product
Role
Manufacturer
Face Oedema
Pruritus
Consumer
Health
Professional
Concerta (Oros
Methylphenidate
Hydrochloride)
PS
Alza Corp
Allergy Shots (Nos)
C
Route
Duration
18-36 MG 1X /
1 DAY
Q 2 WEEKS
PRESENT
2
WK
Date:06/01/01ISR Number: 3733535-5Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
PT
Duration
Company Report #10105
Report Source
Product
Role
Manufacturer
Route
Other
Agitation
Anxiety
Eye Disorder
Consumer
Health
Professional
Concerta (Oros
Methyphenidate
Hydrochloride)
PS
Singulair
C
Alza Corp
ORAL
Route
18MG 1X / 1
DAY, ORAL
PRN PRESENT
Date:06/01/01ISR Number: 3733538-0Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
Company Report #10237
PT
Report Source
Product
Role
Manufacturer
Epistaxis
Headache
Hypertension
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Alza Corp
Duration
36MG 1X / 1
DAY
Date:06/01/01ISR Number: 3733541-0Report Type:Periodic
Age:15 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Company Report #10449
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Hostility
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Alza Corp
ORAL
Zyprexa
C
Depakote
C
54MG 1X / 1
DAY, ORAL
500MG 1X / 1
DAY PRESENT
ER 500MG 1X /
1 DAY PRESENT
18-Aug-2005
Page: 160
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/01ISR Number: 3733543-4Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Company Report #10451
PT
Report Source
Product
Role
Manufacturer
Agitation
Condition Aggravated
Hostility
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Alza Corp
Risperdal
C
ORAL
Clonidine
C
ORAL
Albuterol
C
Dexedrine
C
Theophyl-Sr
C
Route
36 MG QAM +
18 MG Q NOON
1MG 2X / 1
DAY, PO
PRESENT
0.1MG 1X / 1
DAY, PO
PRESENT
2 PUFFS BID
PRN PRESENT
PRESENT
200 MG
PRESENT
Date:06/01/01ISR Number: 3733545-8Report Type:Periodic
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
Company Report #10502
PT
Report Source
Product
Role
Manufacturer
Route
Intentional Misuse
Health
Professional
Concerta
(Methlphenidate Hcl)
PS
Alza Corp
ORAL
Wellbutrin
C
Duration
54G 1X / 1
DAY, ORAL
Date:06/01/01ISR Number: 3733547-1Report Type:Periodic
Age:16 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
Company Report #10503
PT
Report Source
Product
Role
Manufacturer
Abdominal Pain
Diarrhoea
Jaundice
Consumer
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Alza Corp
Route
Duration
54MG 1X / 1
Nausea
DAY
Vomiting
Date:06/01/01ISR Number: 3733550-1Report Type:Periodic
Age:16 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Company Report #10597
PT
Report Source
Product
Role
Manufacturer
Condition Aggravated
Hostility
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Alza Corp
Route
54MG (36MG +
18MG) 1X / 1
DAY
Date:06/01/01ISR Number: 3734201-2Report Type:Periodic
Age:3 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #10274
PT
Report Source
Product
Role
Manufacturer
Route
Hallucination
Health
Concerta
PS
Alza Corp
ORAL
Clonidine
SS
Professional
ORAL
.1MG (2TAB
QHS) - .1MG
(QHS)
18-Aug-2005
Page: 161
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Claritin
Date:06/01/01ISR Number: 3734202-4Report Type:Periodic
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
54MG (3-18MG
C
Company Report #10281
PT
Report Source
Product
Role
Manufacturer
Route
Skin Discolouration
Consumer
Concerta
PS
Alza Corp
ORAL
Route
Health
TABS) / DAY
Professional
Date:06/01/01ISR Number: 3734203-6Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Other
Company Report #10282
PT
Report Source
Product
Role
Manufacturer
Emotional Disorder
Hostility
Health
Professional
Company
Representative
Concerta
PS
Alza Corp
Duration
Date:06/01/01ISR Number: 3734204-8Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG 1X/1DAY,
Company Report #10290
PT
Report Source
Product
Role
Manufacturer
Route
Alopecia
Consumer
Concerta
PS
Alza Corp
ORAL
Clonidine
Zyrtec
C
C
ORAL
Date:06/01/01ISR Number: 3734205-XReport Type:Periodic
Age:3 YR
Gender:Female
I/FU:I
Company Report #10297
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Consumer
Concerta
PS
Alza Corp
ORAL
Personality Disorder
ORAL
Date:06/01/01ISR Number: 3734206-1Report Type:Periodic
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG 1X/
Company Report #10300
PT
Report Source
Product
Role
Manufacturer
Route
Anorexia
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
Nystagmus
1DAY, ORAL
Tic
Vision Blurred
Visual Disturbance
Date:06/01/01ISR Number: 3734207-3Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG 1X/
Company Report #10351
PT
Report Source
Product
Role
Manufacturer
Route
Dizziness
Consumer
Concerta
PS
Alza Corp
ORAL
Visual Disturbance
Health
Duration
1DAY, ORAL
Professional
18-Aug-2005
Page: 162
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/01ISR Number: 3734208-5Report Type:Periodic
Age:15 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/ 1DAY
PT
Report Source
Product
Role
Manufacturer
Confusional State
Consumer
Concerta
PS
Alza Corp
Insomnia
Health
Professional
Tylenol
Motrin
C
C
Date:06/01/01ISR Number: 3734209-7Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG 1X/ 1
Company Report #10352
Route
Company Report #10353
PT
Report Source
Product
Role
Manufacturer
Route
Insomnia
Consumer
Concerta
PS
Alza Corp
ORAL
Rynatan
Mvi
Acidophilos
Vitamin C
C
C
C
C
Duration
Muscle Twitching
DAY, ORAL
Upper Respiratory Tract
Infection
Date:06/01/01ISR Number: 3734210-3Report Type:Periodic
Age:38 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18MG 1X/
Company Report #10363
PT
Report Source
Product
Role
Manufacturer
Route
Diarrhoea
Consumer
Concerta
PS
Alza Corp
ORAL
Role
Manufacturer
Route
Duration
Company
1DAY, ORAL
Representative
Date:06/01/01ISR Number: 3734211-5Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #10367
Report Source
Product
Other
54 MG
Aggression
Consumer
Concerta
PS
Prozac
C
Alza Corp
Condition Aggravated
(3-18,G)1X/1D
Drug Ineffective
AY
Date:06/01/01ISR Number: 3734212-7Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG 1X/1
Company Report #10369
PT
Report Source
Product
Role
Manufacturer
Route
Dermatitis
Consumer
Concerta
PS
Alza Corp
ORAL
Drug Ineffective
Health
Ritalin
C
Duration
DAY, ORAL
Professional
Date:06/01/01ISR Number: 3734213-9Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36MG 1X/1
Company Report #10371
PT
Report Source
Product
Role
Manufacturer
Route
Insomnia
Consumer
Concerta
PS
Alza Corp
ORAL
Clonidine
Claritin
C
C
Duration
DAY, ORAL
18-Aug-2005
Page: 163
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/01ISR Number: 3734214-0Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
ADHD
Company Report #10376
PT
Report Source
Product
Role
Manufacturer
Muscle Twitching
Consumer
Concerta
PS
Alza Corp
Health
Professional
Zoloft
Claritin
Zyrtec
C
C
C
Route
Duration
Date:06/01/01ISR Number: 3734215-2Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
72 MG (2-36MG
Company Report #10379
PT
Report Source
Product
Role
Manufacturer
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
Chest Pain
Health
Headache
Professional
Route
TABS) /DAY
Date:06/01/01ISR Number: 3734216-4Report Type:Periodic
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
36MG TO 18MG
Company Report #10383
PT
Report Source
Product
Role
Manufacturer
Face Oedema
Consumer
Concerta
PS
Alza Corp
Muscle Twitching
Health
Pain
Professional
Route
1X/1DAY
Date:06/01/01ISR Number: 3734217-6Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG 1X/1DAY,
Company Report #10389
PT
Report Source
Product
Role
Manufacturer
Route
Aggression
Health
Concerta
PS
Alza Corp
ORAL
Anxiety
Professional
ORAL
Irritability
Melatonin
Date:06/01/01ISR Number: 3734218-8Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG (2-18MG)
C
Company Report #10396
PT
Report Source
Product
Role
Manufacturer
Route
Hostility
Consumer
Concerta
PS
Alza Corp
ORAL
Nervousness
Health
Tegretol
C
/DAY PO
Professional
Date:06/01/01ISR Number: 3734219-XReport Type:Periodic
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG
Company Report #10398
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
1X/1DAY, ORAL
Date:06/01/01ISR Number: 3734220-6Report Type:Periodic
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36MG-54MG
PT
Report Source
Product
Role
Manufacturer
Route
Asthenia
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
Hyperhidrosis
1X/1DAY, PO
Sedation
18-Aug-2005
Page: 164
Company Report #10407
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/01ISR Number: 3734221-8Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36MG
Company Report #10414
PT
Report Source
Product
Role
Manufacturer
Insomnia
Consumer
Concerta
PS
Alza Corp
Claritin
C
Route
Duration
(2-18MG)/DAY
Date:06/01/01ISR Number: 3734222-XReport Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Duration
Other
54MG(18MG+36M
Company Report #10415
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Health
Concerta
PS
Alza Corp
ORAL
Professional
G)/DAY PO
Company
Representative
Date:06/01/01ISR Number: 3734223-1Report Type:Periodic
Age:60 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
18 MG 1X 1DAY
Company Report #10419
PT
Report Source
Product
Role
Manufacturer
Route
Hostility
Health
Concerta
PS
Alza Corp
ORAL
Professional
ORAL
Date:06/01/01ISR Number: 3734224-3Report Type:Periodic
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #10420
PT
Report Source
Product
Role
Manufacturer
Route
Dermatitis
Health
Concerta
PS
Alza Corp
ORAL
Professional
PO
Concerta
(Methylphenidate
Hcl0
SS
ORAL
18 MG 1X/DAY,
ORAL
Date:06/01/01ISR Number: 3734225-5Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAT
Company Report #10421
PT
Report Source
Product
Role
Manufacturer
Route
Pruritus
Health
Concerta
PS
Alza Corp
ORAL
Rash Maculo-Papular
Professional
ORAL
Date:06/01/01ISR Number: 3734226-7Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36MG 1X/DAY
Company Report #10434
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Consumer
Concerta
PS
Alza Corp
ORAL
Prozac
C
Duration
ORAL
Date:06/01/01ISR Number: 3734227-9Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG-36MG
Company Report #10435
PT
Report Source
Product
Role
Manufacturer
Route
Hostility
Health
Concerta
PS
Alza Corp
ORAL
Duration
Professional
1X/1DAY, PO
18-Aug-2005
Page: 165
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/01ISR Number: 3734228-0Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG
Company Report #10439
PT
Report Source
Product
Role
Manufacturer
Route
Muscle Twitching
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
1X/1DAY, ORAL
Date:06/01/01ISR Number: 3734229-2Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY
Company Report #10442
PT
Report Source
Product
Role
Manufacturer
Route
Dysphonia
Consumer
Concerta
PS
Alza Corp
ORAL
ORAL
Date:06/01/01ISR Number: 3734230-9Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG 1X/1DAY,
Company Report #10446
PT
Report Source
Product
Role
Manufacturer
Route
Anorexia
Consumer
Concerta
PS
Alza Corp
ORAL
Asthenia
PO
Dizziness
Insomnia
Nausea
Date:06/01/01ISR Number: 3734231-0Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #10447
PT
Report Source
Product
Role
Manufacturer
Route
Central Nervous System
Consumer
Concerta
PS
Alza Corp
ORAL
Stimulation
Health
Insomnia
Professional
ORAL
Date:06/01/01ISR Number: 3734232-2Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
54MG/
Company Report #10450
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Consumer
Concerta
PS
Alza Corp
ORAL
Insomnia
Health
Ddavp
C
Duration
1X/1DAY, ORAL
Professional
Date:06/01/01ISR Number: 3734233-4Report Type:Periodic
Age:50 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
72MG 1X/1DAY,
Company Report #10452
PT
Report Source
Product
Role
Manufacturer
Route
Asthenia
Health
Concerta
PS
Alza Corp
ORAL
Dizziness
Professional
Methlyphenidate
C
PO
Date:06/01/01ISR Number: 3734234-6Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
PT
Report Source
Product
Role
Manufacturer
Route
Anorexia
Consumer
Concerta
PS
Alza Corp
ORAL
Vomiting
ORAL
18-Aug-2005
Page: 166
11:49 AM
Company Report #10453
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/01ISR Number: 3734235-8Report Type:Periodic
Age:13 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
54MG 1X/1DAY,
Company Report #10454
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Consumer
Concerta
PS
Alza Corp
ORAL
Haldol
C
ORAL
Date:06/01/01ISR Number: 3734236-XReport Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
72MG(4-18MG)/
Company Report #10466
PT
Report Source
Product
Role
Manufacturer
Route
Confusional State
Consumer
Concerta
PS
Alza Corp
ORAL
Concerta
(Methylphenidate
Hcl)
SS
Clonidine
C
Depression
DAY PO
Emotional Disorder
Sedation
ORAL
72 MG (2-36
MG) DAY PO
Date:06/01/01ISR Number: 3734237-1Report Type:Periodic
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
54MG 1X/1DAY,
Company Report #10467
PT
Report Source
Product
Role
Manufacturer
Route
Pyrexia
Health
Concerta
PS
Alza Corp
ORAL
Vasodilatation
Professional
Clonidine
C
ORAL
Date:06/01/01ISR Number: 3734238-3Report Type:Periodic
Age:14 YR
Gender:Male
I/FU:I
Company Report #10475
Outcome
Dose
Duration
Other
36MG 1X/1DAY,
PT
Report Source
Product
Role
Manufacturer
Route
Hallucination
Health
Concerta
PS
Alza Corp
ORAL
Professional
PO
Date:06/01/01ISR Number: 3734239-5Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAT,
Company Report #10478
PT
Report Source
Product
Role
Manufacturer
Route
Dyskinesia
Health
Concerta
PS
Alza Corp
ORAL
Gait Disturbance
Professional
ORAL
Muscle Twitching
Date:06/01/01ISR Number: 3734240-1Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
54 MG
Company Report #10480
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Consumer
Concerta
PS
Alza Corp
ORAL
Clonidine
C
Duration
1X/1DAY, PO
18-Aug-2005
Page: 167
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/01ISR Number: 3734241-3Report Type:Periodic
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
72MG (54MG +
Company Report #10481
PT
Report Source
Product
Role
Manufacturer
Route
Accidental Overdose
Health
Concerta
PS
Alza Corp
ORAL
Agitation
Professional
Growth Hormone
C
18MG) 2X /
DAY PO
Date:06/01/01ISR Number: 3734242-5Report Type:Periodic
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
54MG 1X/
Company Report #10486
PT
Report Source
Product
Role
Manufacturer
Route
Dermatitis
Health
Concerta
PS
Alza Corp
ORAL
Duration
Professional
1DAY, ORAL
Date:06/01/01ISR Number: 3734243-7Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG PO 5X/ 1
Company Report #10498
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Role
Manufacturer
Route
Headache
WEEK
Pallor
Vomiting
Date:06/01/01ISR Number: 3734244-9Report Type:Periodic
Age:13 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Duration
Company Report #10499
Report Source
Product
Other
36MG (2 -
Hostility
Consumer
Concerta
PS
Clonidine
C
Alza Corp
18MG TAB) 1X/
1 DAY
Date:06/01/01ISR Number: 3734245-0Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG 1X/1DAY,
Company Report #10500
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Anorexia
Health
ORAL
Professional
Date:06/01/01ISR Number: 3734246-2Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG 1X/
Company Report #10508
PT
Report Source
Product
Role
Manufacturer
Route
Tremor
Consumer
Concerta
PS
Alza Corp
ORAL
Zoloft
C
Duration
1DAY, ORAL
Date:06/01/01ISR Number: 3734247-4Report Type:Periodic
Age:13 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 168
PT
Abdominal Pain
Anorexia
11:49 AM
Company Report #10514
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Headache
Dose
Report Source
Product
Role
Manufacturer
Route
Consumer
Concerta
PS
Alza Corp
ORAL
Route
Duration
36MG 1X/
1DAY, ORAL
Date:06/01/01ISR Number: 3734248-6Report Type:Periodic
Age:15 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/ 1DAY
Company Report #10574
PT
Report Source
Product
Role
Manufacturer
Anxiety
Consumer
Concerta
PS
Alza Corp
Concerta
(Methylphenidate
Hcl)
SS
Alza Corp
Drug Ineffective
Headache
36MG (2 18MG TABS)
1X/ 1 DAY
Date:06/01/01ISR Number: 3734249-8Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG 1X/
Company Report #10577
PT
Report Source
Product
Role
Manufacturer
Route
Bradycardia
Health
Concerta
PS
Alza Corp
ORAL
Headache
Professional
Role
Manufacturer
Route
Duration
1DAY, ORAL
Hypotension
Date:06/01/01ISR Number: 3734250-4Report Type:Periodic
Age:13 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Duration
Company Report #10578
Report Source
Product
Other
36MG 1X/
Anxiety
Consumer
Concerta
PS
Alza Corp
ORAL
Dizziness
1DAY, ORAL
Hypertonia
Palpitations
Date:06/01/01ISR Number: 3734251-6Report Type:Periodic
Age:21 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #10579
PT
Report Source
Product
Role
Manufacturer
Route
Epistaxis
Consumer
Concerta
PS
Alza Corp
ORAL
Headache
Health
Glucophage
SS
Birth Control Pill
(Nos)
C
ORAL
Professional
500MG 2X/
1DAY
Date:06/01/01ISR Number: 3734252-8Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG 1X/
PT
Report Source
Product
Role
Manufacturer
Route
Coagulation Time
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
Prolonged
1DAY, ORAL
18-Aug-2005
Page: 169
Company Report #10580
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/01ISR Number: 3734253-XReport Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG 1X/
Company Report #10581
PT
Report Source
Product
Role
Manufacturer
Route
Anxiety
Health
Concerta
PS
Alza Corp
ORAL
Hypertension
Professional
Duration
1DAY, ORAL
Tachycardia
Date:06/01/01ISR Number: 3734254-1Report Type:Periodic
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
54MG 1X/
Company Report #10588
PT
Report Source
Product
Role
Manufacturer
Route
Halitosis
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
Health
1DAY, ORAL
Professional
Date:06/01/01ISR Number: 3734255-3Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG 1X/
Company Report #10589
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Route
Duration
Insomnia
1DAY, ORAL
Rhinitis
Date:06/01/01ISR Number: 3734256-5Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG 1X/
Company Report #10601
PT
Report Source
Product
Role
Manufacturer
Drug Ineffective
Consumer
Concerta
PS
Alza Corp
Duration
Health
1DAY
Professional
Date:06/01/01ISR Number: 3734257-7Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36MG 1X/
Company Report #10602
PT
Report Source
Product
Role
Manufacturer
Route
Attention
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
Deficit/Hyperactivity
1DAY, ORAL
Disorder
Condition Aggravated
Date:06/01/01ISR Number: 3734258-9Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG 1X/
Company Report #10610
PT
Report Source
Product
Role
Manufacturer
Route
Pruritus
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
Urticaria
1DAY, ORAL
Date:06/01/01ISR Number: 3734259-0Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36 MG 1X/ 1
Company Report #10611
PT
Report Source
Product
Role
Manufacturer
Route
Drug Effect Decreased
Health
Concerta
PS
Alza Corp
ORAL
Professional
DAY, ORAL
18-Aug-2005
Page: 170
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/01ISR Number: 3734260-7Report Type:Periodic
Age:4 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG 1X/
Company Report #10612
PT
Report Source
Product
Role
Manufacturer
Route
Agitation
Health
Concerta
PS
Alza Corp
ORAL
Emotional Disorder
Professional
Gait Disturbance
Hallucination
Insomnia
Company
Representative
Depakote
C
Duration
1DAY, ORAL
Date:06/01/01ISR Number: 3734261-9Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY
Company Report #10617
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Consumer
Concerta
PS
Alza Corp
ORAL
Eructation
ORAL
Date:06/01/01ISR Number: 3734262-0Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18 MG 1X/1DAY
Company Report #10618
PT
Report Source
Product
Role
Manufacturer
Route
Emotional Disorder
Health
Concerta
PS
Alza Corp
ORAL
Insomnia
Professional
Proventil
C
ORAL
Date:06/01/01ISR Number: 3734263-2Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY
Company Report #10619
PT
Report Source
Product
Role
Manufacturer
Route
Emotional Disorder
Health
Concerta
PS
Alza Corp
ORAL
Professional
ORAL
Date:06/01/01ISR Number: 3734264-4Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY
Company Report #10620
PT
Report Source
Product
Role
Manufacturer
Route
Emotional Disorder
Health
Concerta
PS
Alza Corp
ORAL
Hyperventilation
Professional
ORAL
Tachycardia
Tremor
Date:06/01/01ISR Number: 3734265-6Report Type:Periodic
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18MG
Company Report #10621
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Health
Concerta
PS
Alza Corp
ORAL
Duration
Professional
1X/1DAY/ORAL
Date:06/01/01ISR Number: 3734266-8Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG 2X/2DAY,
Company Report #10626
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Consumer
Concerta
PS
Alza Corp
ORAL
Metadate Er
Ritalin
C
C
PO
18-Aug-2005
Page: 171
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/01ISR Number: 3734267-XReport Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36MG
Company Report #10627
PT
Report Source
Product
Role
Manufacturer
Route
Chest Pain
Health
Concerta
PS
Alza Corp
ORAL
Dyspnoea
Professional
Route
Duration
1X/1DAY/ORAL
Date:06/01/01ISR Number: 3734268-1Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Other
UNKNOWN
PT
Company Report #10628
Report Source
Product
Role
Manufacturer
Health
Concerta
PS
Alza Corp
Duration
Back Pain
DOSE/FREQUENC
Professional
Y UNK
Company
Representative
Date:06/01/01ISR Number: 3734269-3Report Type:Periodic
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
UNKNOWN
PT
Company Report #10633
Report Source
Product
Role
Manufacturer
Health
Concerta
PS
Alza Corp
Zoloft
SS
Route
Duration
Laboratory Test Abnormal
DOSAGE/FREQUE
Professional
NCY UNKNOWN
50MG
Date:06/01/01ISR Number: 3734270-XReport Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
72 MG 1X/1DAY
Company Report #10634
PT
Report Source
Product
Role
Manufacturer
Weight Increased
Consumer
Concerta
PS
Alza Corp
Route
Date:06/01/01ISR Number: 3734271-1Report Type:Periodic
Age:44 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
54MG
Company Report #10637
PT
Report Source
Product
Role
Manufacturer
Route
Headache
Consumer
Concerta
PS
Alza Corp
ORAL
Imitrex
Amerge
C
C
Route
Duration
(2-18+1-18MG)
/DAY PO
Date:06/01/01ISR Number: 3734272-3Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY
Company Report #10638
PT
Report Source
Product
Role
Manufacturer
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
Concerta
(Methylphenidate
Hcl)
SS
Drug Ineffective
36MG 1X/1DAY
Date:06/01/01ISR Number: 3734273-5Report Type:Periodic
Age:13 YR
Gender:Female
I/FU:I
Outcome
Other
18-Aug-2005
Page: 172
PT
Dizziness
Muscle Twitching
Oedema Peripheral
11:49 AM
Company Report #10645
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Skin Discolouration
Dose
Report Source
Product
Role
Manufacturer
Consumer
Concerta
PS
Alza Corp
Route
Duration
36MG (2-18MG
Health
TAB)
Professional
Date:06/01/01ISR Number: 3734274-7Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG ((2-18MG
Company Report #10650
PT
Report Source
Product
Role
Manufacturer
Route
Headache
Consumer
Concerta
PS
Alza Corp
ORAL
Concerta
(Methylphenidate
Hcl)
SS
Nausea
TAB) 1 DAY PO
Vomiting
ORAL
18MG
(1X-1DAY,
ORAL)
Date:06/01/01ISR Number: 3734275-9Report Type:Periodic
Age:40 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
72MG
Company Report #10660
PT
Report Source
Product
Role
Manufacturer
Anxiety
Health
Concerta
PS
Alza Corp
Back Pain
Professional
Grifulvin
Ventolin
C
C
Duration
(54MG+18MG1X/
Myalgia
X1DAY)
Pyrexia
Route
Date:06/01/01ISR Number: 3734276-0Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
54MG 1X/1DAY,
Company Report #10663
PT
Report Source
Product
Role
Manufacturer
Route
Headache
Consumer
Concerta
PS
Alza Corp
ORAL
Route
Nausea
ORAL
Nervousness
Sedation
Date:06/01/01ISR Number: 3734277-2Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Other
UNKNOWN
PT
Company Report #10666
Report Source
Product
Role
Manufacturer
Health
Concerta
PS
Alza Corp
Duration
Dyspnoea
DOSAGE-UNK
Professional
Company
Representative
Date:06/01/01ISR Number: 3734278-4Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
PT
Report Source
Product
Role
Manufacturer
Route
Dyskinesia
Consumer
Concerta
PS
Alza Corp
ORAL
Paranoia
ORAL
Sedation
Speech Disorder
18-Aug-2005
Page: 173
11:49 AM
Company Report #10667
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/01ISR Number: 3734279-6Report Type:Periodic
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
UNKNOWN
PT
Company Report #10721
Report Source
Product
Role
Manufacturer
Health
Concerta
PS
Alza Corp
Route
Duration
Hypertension
DOSE UNKNOWN
Professional
Company
Representative
Date:06/01/01ISR Number: 3734280-2Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
54MG
Company Report #10727
PT
Report Source
Product
Role
Manufacturer
Route
Growth Retardation
Health
Concerta
PS
Alza Corp
ORAL
Headache
Professional
Duration
(18+36MG)1X/1
Nausea
DAY PO
Vomiting
Date:06/01/01ISR Number: 3734281-4Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG(2-18MG)
Company Report #10728
PT
Report Source
Product
Role
Manufacturer
Route
Hypertension
Health
Concerta
PS
Alza Corp
ORAL
Lisinopril
Amlodipine
C
C
Manufacturer
Route
Professional
1X/1DAY PO
Date:06/01/01ISR Number: 3734282-6Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #10730
Report Source
Product
Role
Other
18MG 1X/1DAY,
Leukocytosis
Consumer
Concerta
PS
Alza Corp
ORAL
Purpura
ORAL
Date:06/01/01ISR Number: 3734283-8Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG 1X/1DAY,
Company Report #10731
PT
Report Source
Product
Role
Manufacturer
Route
Dermatitis
Consumer
Concerta
PS
Alza Corp
ORAL
Topamax
C
Face Oedema
ORAL
Date:06/01/01ISR Number: 3734284-XReport Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #10732
PT
Report Source
Product
Role
Manufacturer
Route
Agitation
Health
Concerta
PS
Alza Corp
ORAL
Hostility
Professional
ORAL
Nervousness
Date:06/01/01ISR Number: 3734285-1Report Type:Periodic
Age:12 YR
Gender:Female
I/FU:I
Outcome
Other
18-Aug-2005
Page: 174
PT
Confusional State
Muscle Twitching
11:49 AM
Company Report #10733
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Personality Disorder
Thinking Abnormal
Dose
Report Source
Product
Role
Manufacturer
Route
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
36 1X/1DAY,
PO
Date:06/01/01ISR Number: 3734286-3Report Type:Periodic
Age:68 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG 1X/1DAY,
Company Report #10734
PT
Report Source
Product
Role
Manufacturer
Route
Anxiety
Consumer
Concerta
PS
Alza Corp
ORAL
Triamterene
Atenolol
C
C
Nervousness
ORAL
Thinking Abnormal
Date:06/01/01ISR Number: 3734287-5Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #10743
PT
Report Source
Product
Role
Manufacturer
Route
Anxiety
Consumer
Concerta
PS
Alza Corp
ORAL
Paxil
C
Depression
ORAL
2
DAY
Muscle Twitching
Date:06/01/01ISR Number: 3734288-7Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG 1X/1DAY,
PT
Report Source
Product
Role
Manufacturer
Route
Keratoconjunctivitis
Consumer
Concerta
PS
Alza Corp
ORAL
Sicca
ORAL
Company Report #10747
Muscle Twitching
Date:06/01/01ISR Number: 3734289-9Report Type:Periodic
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
18MG TO 54MG
Company Report #10748
PT
Report Source
Product
Role
Manufacturer
Attention
Consumer
Concerta
PS
Alza Corp
Akne-Mycin Cream
C
Route
Deficit/Hyperactivity
1X/1DAY
Disorder
Emotional Disorder
Personality Disorder
Thinking Abnormal
Date:06/01/01ISR Number: 3734290-5Report Type:Periodic
Age:
Gender:Not SpecifiI/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #10781
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Consumer
Concerta
PS
Alza Corp
ORAL
Health
ORAL
Professional
18-Aug-2005
Page: 175
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/01ISR Number: 3734462-XReport Type:Periodic
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG 1X/1DAY,
Company Report #10639
PT
Report Source
Product
Role
Manufacturer
Route
Leukopenia
Consumer
Concerta
PS
Alza Corp
ORAL
Thrombocytopenia
Health
Accutane
SS
ORAL
Professional
Date:06/01/01ISR Number: 3734463-1Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #10214
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Route
Diarrhoea
ORAL
Headache
Vomiting
Date:06/01/01ISR Number: 3734464-3Report Type:Periodic
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
27MG
Company Report #10221
PT
Report Source
Product
Role
Manufacturer
Dyskinesia
Consumer
Concerta
PS
Alza Corp
Ritalin
Proventil
Centrum Vitamins
Citracal Calcium
Supplement
C
C
C
Duration
Health
(1.5-18MG
Professional
TAB) / 1DAY
C
Date:06/01/01ISR Number: 3734466-7Report Type:Periodic
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #10235
PT
Report Source
Product
Role
Manufacturer
Route
Urticaria
Consumer
Concerta
PS
Alza Corp
ORAL
Health
ORAL
Professional
Date:06/01/01ISR Number: 3734467-9Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG
Company Report #10239
PT
Report Source
Product
Role
Manufacturer
Route
Abnormal Dreams
Health
Concerta
PS
Alza Corp
ORAL
Hallucination
Professional
Augmentin
Guaifenesin
C
C
Duration
1X/1DAY, PO
Company
Representative
Date:06/01/01ISR Number: 3734468-0Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 176
PT
Chest Pain
Dyspnoea
Emotional Disorder
Hostility
Insomnia
Nausea
11:49 AM
Company Report #10241
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Vomiting
Dose
Report Source
Product
Role
Manufacturer
Route
Consumer
Concerta
PS
Alza Corp
ORAL
Route
Duration
18-36MG
Health
1X/1DAY, PO
Professional
Date:06/01/01ISR Number: 3734470-9Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
72MG (4-18MG
Company Report #10242
PT
Report Source
Product
Role
Manufacturer
Condition Aggravated
Consumer
Concerta
PS
Alza Corp
Clonidine
Catapressan
C
C
Personality Disorder
TABS)/1DAY
Date:06/01/01ISR Number: 3734471-0Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
54MG
Company Report #10243
PT
Report Source
Product
Role
Manufacturer
Agitation
Consumer
Concerta
PS
Alza Corp
Route
Duration
Mydriasis
(36MG+18MG)
1X/1DAY
Date:06/01/01ISR Number: 3734472-2Report Type:Periodic
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG
Company Report #10244
PT
Report Source
Product
Role
Manufacturer
Route
Amnesia
Consumer
Concerta
PS
Alza Corp
ORAL
Duration
Skin Disorder
1X/1DAY, ORAL
Tachycardia
Date:06/01/01ISR Number: 3734474-6Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36 MG 1X/1DAY
Company Report #10245
PT
Report Source
Product
Role
Manufacturer
Drug Ineffective
Consumer
Concerta
PS
Alza Corp
Route
Health
Professional
Date:06/01/01ISR Number: 3734476-XReport Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #10246
PT
Report Source
Product
Role
Manufacturer
Route
Chest Pain
Health
Concerta
PS
Alza Corp
ORAL
Paraesthesia
Professional
Route
ORAL
Date:06/01/01ISR Number: 3734477-1Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG-54MG
Company Report #10247
PT
Report Source
Product
Role
Manufacturer
Drug Ineffective
Consumer
Concerta
PS
Alza Corp
Zyprexa
Mvi
C
C
Duration
1X/1DAY
18-Aug-2005
Page: 177
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/01ISR Number: 3734479-5Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Other
DOSAGE-
Company Report #10248
PT
Report Source
Product
Role
Manufacturer
Psychomotor Hyperactivity
Health
Concerta
PS
Alza Corp
Route
Duration
Professional
Company
Representative
Date:06/01/01ISR Number: 3734480-1Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
54MG (3-18MG)
Company Report #10249
PT
Report Source
Product
Role
Manufacturer
Drug Ineffective
Consumer
Concerta
PS
Alza Corp
Tenex
Ritalin
C
C
Route
1X/1 DAY
Date:06/01/01ISR Number: 3734481-3Report Type:Periodic
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG (2-18MG)
Company Report #10257
PT
Report Source
Product
Role
Manufacturer
Tremor
Consumer
Concerta
PS
Alza Corp
Route
Health
1X/1DAY
Professional
Date:06/01/01ISR Number: 3734483-7Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG 1X/1DAY,
Company Report #10258
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Consumer
Concerta
PS
Alza Corp
ORAL
Hostility
PO
Mvi
Date:06/01/01ISR Number: 3734484-9Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
C
Company Report #10259
PT
Report Source
Product
Role
Manufacturer
Route
Headache
Consumer
Concerta
PS
Alza Corp
ORAL
Penicillin
C
ORAL
Date:06/01/01ISR Number: 3734486-2Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18MG 1X/1DAY,
Company Report #10271
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
ORAL
Route
Drug Ineffective
ORAL
Date:06/01/01ISR Number: 3734487-4Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG (2-18MG
Company Report #10272
PT
Report Source
Product
Role
Manufacturer
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
Anxiety
Health
Hyperacusis
Professional
1X/DAY)
18-Aug-2005
Page: 178
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/01/01ISR Number: 3734489-8Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
72MG PO X
Company Report #10273
PT
Report Source
Product
Role
Manufacturer
Abdominal Pain
Consumer
Concerta
PS
Alza Corp
Paxil
Risperdal
Allegra
Accolate
Ranitidine
Atrovent
Promethazine
Benadryl
Epipen Prn
C
C
C
C
C
C
C
C
C
Route
Duration
1/DAY
Date:06/04/01ISR Number: 3733536-7Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #A107244
PT
Report Source
Product
Role
Manufacturer
Sedation
Health
Professional
Geodon
PS
Pfizer Central
Research
Methyphenidate
SS
Clonidine
C
Route
Duration
20.00 MG
TOTAL:DAILY
5.00 MG TOTAL
Date:06/06/01ISR Number: 3736117-4Report Type:Periodic
Age:38 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
20 MG ER, TID
Company Report #MK200105-0085-1
PT
Report Source
Product
Role
Manufacturer
Drug Ineffective
Health
Methylin Er
PS
Mallinckrodt Inc
Professional
Route
Date:06/11/01ISR Number: 3737167-4Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Company Report #2000-10-1252
PT
Report Source
Product
Role
Manufacturer
Route
Drug Effect Decreased
Drug Interaction
Health
Professional
Claritin
PS
Schering Corp Sub
Schering Plough Corp
ORAL
Duration
ORAL
Ritalin
SS
UNKNOWN
Date:06/11/01ISR Number: 3737979-7Report Type:Expedited (15-DaCompany Report #PHBS2001JP05750
Age:49 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
150
PT
Report Source
Product
Role
Manufacturer
Route
Intentional Misuse
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Professional
TABLETS/D,
Other
ORAL
Date:06/18/01ISR Number: 3741505-6Report Type:Expedited (15-DaCompany Report #MPI-2001-05755 (0)
Age:13 YR
Gender:Male
I/FU:I
Outcome
Death
Other
18-Aug-2005
Page: 179
PT
Abdominal Pain
Abdominal Pain Upper
Anger
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Anxiety
Depression
Emotional Disorder
Dose
Report Source
Product
Role
Manufacturer
Consumer
Other
Methylphenidate Hcl
PS
Celltech
Manufacturing Inc
Ritalin
(Methylphenidate
Hydrochloride)
SS
Route
Duration
Fatigue
Fear
Headache
Hostility
Injury
30MG PER DAY,
Insomnia
UNK
Mental Disorder
Murder
Personality Disorder
Suicidal Ideation
Weight Decreased
Date:06/19/01ISR Number: 3742460-5Report Type:Expedited (15-DaCompany Report #10908
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 18MG 1X/1
Initial or Prolonged
DAY, ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Agitation
Health
Concerta
PS
Alza Corp
ORAL
Condition Aggravated
Professional
Delsym
Ibuprofen
C
C
Dystonia
Irritability
Psychomotor Hyperactivity
Date:06/20/01ISR Number: 3743570-9Report Type:Expedited (15-DaCompany Report #MPI-2001-05759(0)
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Platelet Count Decreased
Viral Infection
Health
Professional
Metadate Er
PS
Celltech
Manufacturing Inc
ORAL
Duration
40MG IN AM &
20MG
AFTERNOON, PO
Date:06/21/01ISR Number: 3743750-2Report Type:Direct
Age:5 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Required
Intervention to
18MG 3X IN
Prevent Permanent
THE AM ORAL
Impairment/Damage
PT
18-Aug-2005
Page: 180
11:49 AM
Report Source
Aggression
Date:06/21/01ISR Number: 3743751-4Report Type:Direct
Age:4 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Required
5MG 2X A DAY
Intervention to
ORAL
Prevent Permanent
Impairment/Damage
Company Report #
PT
Aggression
Product
Role
Manufacturer
Route
Concerta Er 1mg Tab
Alza
PS
Tab A;Z
ORAL
Buspar
Zyprexa
Topamax
Claritin
C
C
C
C
Manufacturer
Route
Company Report #
Report Source
Product
Role
Methylphenidate 5mg
PS
Buspar
Zyprexa
Topomax
C
C
C
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/25/01ISR Number: 3747230-XReport Type:Expedited (15-DaCompany Report #MPI-2001-05776 (0)
Age:3 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
20 MG, ONCE
PT
Report Source
Product
Role
Manufacturer
Abnormal Behaviour
Health
Professional
Metadate Cd
PS
Celltech
Pharmaceuticals Inc
Route
Date:06/29/01ISR Number: 3750829-8Report Type:Expedited (15-DaCompany Report #MPI-2001-05774(0)
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Aggression
Condition Aggravated
Foreign
Literature
Methylphenidate Hcl
PS
Celltech
Manufacturing Inc
Drug Tolerance Decreased
Feeling Abnormal
Impulsive Behaviour
Obsessive-Compulsive
Disorder
Tic
Health
Professional
Route
Duration
40MG DAILY,
Date:07/02/01ISR Number: 3751030-4Report Type:Expedited (15-DaCompany Report #PHEH2001US05251
Age:
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Drug Interaction
Psychotic Disorder
Health
Professional
Ritalin
PS
Novartis
Pharmaceuticals Corp
Provigil (Modafinil)
Corticosteroids (No
Ingredients/Substanc
es)
SS
Route
Duration
C
Date:07/02/01ISR Number: 3751453-3Report Type:Expedited (15-DaCompany Report #001-0981-M0104621
Age:56 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Hospitalization 10 MG
Initial or Prolonged
(DAILY), PER
Other
ORAL
Alanine Aminotransferase
Health
Increased
Professional
Lipitor
PS
Pfizer Inc
ORAL
Fluoxetine
(Fluoxetine)
SS
ORAL
Omeprazole
(Omeprazole)
SS
ORAL
Methylphenidate
(Methylphenidate)
SS
ORAL
Alprazolam
(Alprazolam)
SS
Aspartate
Aminotransferase
Increased
60 MG (TWICE
Blood Bilirubin Increased
DAY), PER
Clumsiness
ORAL
Electrocardiogram
Abnormal
40 MG
Global Amnesia
(DAILY), PER
Weight Increased
ORAL
30 MG (TWICE
DAILY), PER
ORAL
18-Aug-2005
Page: 181
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/02/01ISR Number: 3751793-8Report Type:Expedited (15-DaCompany Report #PHBS2001JP06327
Age:86 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Delirium
Hallucination, Visual
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
40 MG/DAY,
Professional
ORAL
Other
Fluvoxamine Maleate
(Fluvoxamine
Maleate)
SS
ORAL
Loramet
(Lormetazepam)
SS
ORAL
75 MG/DAY,
ORAL
2 MG/DAY,
ORAL
Date:07/03/01ISR Number: 3752105-6Report Type:Expedited (15-DaCompany Report #MPU-2001-00179(0)
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Arrhythmia
Electrocardiogram Qt
Foreign
Health
Methylphenidate Hcl
PS
Celltech
Manufacturing Inc
Prolonged
Professional
Duration
5MG ONCE
DAILY, 10MG
TWICE DAILY,
AND 5 MG AT
4:00 PM
Date:07/05/01ISR Number: 3753020-4Report Type:Expedited (15-DaCompany Report #PHBS2001JP06554
Age:16 YR
Gender:Male
I/FU:I
Route
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Hallucination
Foreign
Literature
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Health
Professional
Anafranil
(Clomipramine)
SS
Other
Pemoline
C
ORAL
ORAL
Date:07/09/01ISR Number: 3754852-9Report Type:Direct
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
72 MG ONCE IN
PT
Company Report #
Report Source
Aggression
Product
Role
Manufacturer
Route
Concerta 36 Mg Alza
PS
Alza
ORAL
Manufacturer
Route
Hallucination
AM ORAL
Suicidal Ideation
Date:07/10/01ISR Number: 3755727-1Report Type:Expedited (15-DaCompany Report #2013273
Age:45 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
18-Aug-2005
Page: 182
PT
Report Source
Product
Role
Drug Toxicity
Toxicologic Test Abnormal
Health
Professional
Other
Morphine Sulfate
(Similar To Nda
19-516)
Alprazolam
Methylphenidate Hcl
Nordiazepam
Chlordiazepoxide
PS
SS
SS
SS
SS
Duration
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/10/01ISR Number: 3756640-6Report Type:Expedited (15-DaCompany Report #2013274
Age:45 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Accidental Overdose
Health
Professional
Other
Morphine Sulfate
(Similar To Andas
74-769 And 74-862)
Alprazolam
Methylphenidate Hcl
Nordiazepam
Chlordiazepoxide
PS
SS
SS
SS
SS
Manufacturer
Route
Route
Duration
Date:07/11/01ISR Number: 3756815-6Report Type:Expedited (15-DaCompany Report #PHFR2001IE01924
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Circulatory Collapse
Foreign
Health
Professional
Other
Ritalin
PS
Novartis
Pharmaceuticals Corp
Date:07/13/01ISR Number: 3758454-XReport Type:Expedited (15-DaCompany Report #PHBS2001JP06554
Age:16 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Hallucination, Tactile
Hallucinations, Mixed
Foreign
Literature
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Health
Professional
Anafranil
(Clomipramine)
SS
Other
Pemoline
SS
ORAL
ORAL
Date:07/16/01ISR Number: 3759030-5Report Type:Direct
Age:35 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Duration
Company Report #
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Methylin 20mg
Mallinckrod
PS
Mallinckrod
2 TIMES
Date:07/16/01ISR Number: 3759488-1Report Type:Expedited (15-DaCompany Report #HQ3176612JUL2001
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Death
Health
Professional
Effexor Xr
PS
Wyeth Ayerst
Laboratories
ORAL
Company
Representative
Methylphenidate
(Methylphenidate)
Duration
ORAL
Date:07/18/01ISR Number: 3760233-4Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
SS
Company Report #
Report Source
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis
ORAL
Ritalin
SS
Novartis
ORAL
Duration
Medication Error
400 TABS
270 TABS
18-Aug-2005
Page: 183
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/18/01ISR Number: 3761064-1Report Type:Expedited (15-DaCompany Report #PERCODAN2001-00174
Age:44 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Atherosclerosis
Blood Alcohol Increased
Coronary Artery Disease
Ecchymosis
Excoriation
Haemangioma Of Liver
Laceration
Laryngeal Disorder
Lung Disorder
Overdose
Pericardial Effusion
Pleural Disorder
Spleen Disorder
Sputum Discoloured
Health
Professional
Percodan
PS
Endo Pharmaceuticals
Inc
Alfentanil
Fentanyl
Sufentanil
Methyl-Phenidate
SS
SS
SS
SS
Route
Duration
Date:07/19/01ISR Number: 3762218-0Report Type:Expedited (15-DaCompany Report #PHBS2001JP00910
Age:3 DY
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Clonic Convulsion
Complications Of Maternal
Foreign
Literature
Ritalin
PS
Novartis
Pharmaceuticals Corp
Exposure To Therapeutic
Drugs
Convulsion Neonatal
Dyskinesia
Health
Professional
Other
Anafranil
(Clomipramine
Hydrochloride)
Tablet
SS
Wintermin
(Chlorpromazine
Hydrochloride)
SS
Serenace
(Haloperidol)
SS
Contomin
(Chlorpromazine
Hydrochloride)
SS
Duration
TRANSPLACENTAL
TRANSPLACENTAL
Jaundice Neonatal
Neonatal Disorder
TRANSPLACENTAL
TRANSPLACENTAL
TRANSPLACENTAL
Artane
Route
(Trihexyphenidyl
Hydrochloride)
SS
TRANSPLACENTAL
Date:07/20/01ISR Number: 3762329-XReport Type:Direct
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #
Report Source
Product
Role
Manufacturer
Route
PS
Alza Corporation
ORAL
SS
Ciba
ORAL
Product
Role
Manufacturer
Route
Ritalin (5 Mg)
PS
Duration
Abnormal Behaviour
Psychomotor Hyperactivity
Concerta 18mg
Corporation
Alza
18MG QAM ORAL
Ritalin 10mg Ciba
10MG 11AM
ORAL
Date:07/20/01ISR Number: 3762381-1Report Type:Direct
Age:
Gender:Male
I/FU:U
Outcome
Dose
PT
Report Source
Duration
Dermatitis
Hypersensitivity
Psychomotor Hyperactivity
18-Aug-2005
Page: 184
Company Report #
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/23/01ISR Number: 3763706-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB02046
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Aggression
Feeling Abnormal
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
Obsessive-Compulsive
Disorder
Tic
Professional
Other
Route
Duration
20-40 MG/DAY
Date:07/23/01ISR Number: 3766038-2Report Type:Periodic
Age:
Gender:Female
I/FU:I
Outcome
Dose
Death
Company Report #US008207
PT
Report Source
Product
Role
Manufacturer
Drug Interaction
Psychotic Disorder
Health
Professional
Company
Representative
Provigil
Ritalin
Corticosteroids
PS
SS
SS
Cephalon Inc
Route
Duration
Date:07/26/01ISR Number: 3766406-9Report Type:Expedited (15-DaCompany Report #PHFR2001GB02070
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Dysphoria
Foreign
Health
Professional
Ritalin
PS
Novartis
Pharmaceuticals Corp
Route
Duration
Date:07/27/01ISR Number: 3766931-0Report Type:Expedited (15-DaCompany Report #PHFR2001GB02086
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Electrocardiogram Qt
Prolonged
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
5 0MG DAILY,
Professional
ORAL
Other
Date:07/27/01ISR Number: 3767108-5Report Type:Expedited (15-DaCompany Report #2001065051US
Age:9 YR
Gender:Male
I/FU:I
Outcome
PT
Dose
Duration
Life-Threatening
Pituitary Tumour
Hospitalization Initial or Prolonged
Disability
Other
Required
Intervention to
15 MG, QD
1203 DAY
Prevent Permanent
Impairment/Damage
500 MG, QD
25 MG, QD
18-Aug-2005
Page: 185
11:49 AM
Report Source
Product
Role
Manufacturer
Study
Health
Professional
Genotropin
(Somatropin) Powder,
Sterile
PS
Pharmacia And Upjohn
Co
Cortef
(Hydrocortisone)
Tablet
SS
Tegretol
(Carbamazepine)
SS
Ritalin
(Methylphenidate
Hydrochloride)
SS
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/31/01ISR Number: 3768556-XReport Type:Expedited (15-DaCompany Report #MPI-2001-05047(1)
Age:15 YR
Gender:Female
I/FU:F
Outcome
Dose
PT
Report Source
Product
Role
Manufacturer
Amnesia
Blood Pressure Increased
Foreign
Literature
Methylphenidate Hcl
PS
Celltech
Manufacturing Inc
Circulatory Collapse
Health
Cyanosis
Pulse Absent
Pyrexia
Respiratory Arrest
Visual Disturbance
Professional
Route
Duration
10 OR 20 MG
ONCE;
Date:07/31/01ISR Number: 3769099-XReport Type:Expedited (15-DaCompany Report #PHBS2001JP00910
Age:4 DY
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Complications Of Maternal
Exposure To Therapeutic
TRANSPLACENTA
Drugs
Foreign
Literature
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
Convulsion Neonatal
Drug Withdrawal Syndrome
Neonatal
TRANSPLACENTA
Dyskinesia
Professional
Other
Anafranil
(Clomipramine
Hydrochloride)
SS
Wintermin
(Chlorpromazine
Hydrochloride)
SS
Serenace
(Haloperidol)
SS
Duration
TRANSPLACENTAL
Health
L
TRANSPLACENTAL
L
Jaundice Neonatal
TRANSPLACENTAL
TRANSPLACENTA
L
TRANSPLACENTAL
TRANSPLACENTA
L
Contomin
(Chlorpromazine
Route
TRANSPLACENTAL
Hydrochloride)
SS
Artane
(Trihexyphenidyl
Hydrochloride)
SS
TRANSPLACENTA
L
TRANSPLACENTAL
TRANSPLACENTA
L
Date:08/01/01ISR Number: 3769511-6Report Type:Expedited (15-DaCompany Report #MPI-2001-05759(1)
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Platelet Count Decreased
Health
Professional
Metadate Er
PS
Celltech
Manufacturing Inc
ORAL
Duration
30 MG, QAM,
PO
Date:08/08/01ISR Number: 3773299-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02070
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
20 MG/DAY,
ORAL
18-Aug-2005
Page: 186
PT
Report Source
Product
Role
Manufacturer
Route
Dysphoria
Foreign
Health
Professional
Other
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/08/01ISR Number: 3773455-3Report Type:Expedited (15-DaCompany Report #PHBS2001US07798
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Drug Interaction
Drug Level Above
Literature
Health
Sandimmune
PS
Novartis
Pharmaceuticals Corp
ORAL
Therapeutic
Professional
Duration
420 MG/D,
ORAL
22
DAY
Drug Level Below
Therapeutic
75 MG, BID
5 MG, BID
22
22
Bupropion
(Amfebutamone)
SS
Methylphenidate
(Methylphenidate
Hydrochloride)
SS
DAY
DAY
Azathioprine
(Azathioprine)
Prednisone
Dipyridamole
(Dipyridamole)
Nifedipine
Sulfamethoxazole
W/Trimethoprim
(Sulfamethoxazole)
Calcium Carbonate
Aluminium Hyrdoxide
W/Magnesium
Hydroxide
C
C
C
C
C
C
C
Date:08/09/01ISR Number: 3775251-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB02214
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Electrocardiogram Qt
Prolonged
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
10 MG, TID,
Professional
ORAL
Other
Date:08/09/01ISR Number: 3775259-4Report Type:Expedited (15-DaCompany Report #PHFR2001IE01924
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Circulatory Collapse
Foreign
Health
Professional
Other
Ritalin
PS
Novartis
Pharmaceuticals Corp
Product
Role
Manufacturer
Route
Ritalin / 25&15 Mgs
/ Novartis
PS
Novartis
ORAL
Date:08/13/01ISR Number: 3775962-6Report Type:Direct
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Company Report #
Report Source
Duration
Arrhythmia
Headache
25 MGS AM, 15
Nausea
MGS NOON ORAL
Date:08/13/01ISR Number: 3775981-XReport Type:Expedited (15-DaCompany Report #HQ3176612JUL2001
Age:
Gender:Unknown
I/FU:F
Outcome
Death
18-Aug-2005
Page: 187
Route
PT
No Adverse Drug Effect
11:49 AM
Report Source
Health
Professional
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Company
Representative
Dose
Product
Role
Manufacturer
Route
Effexor Xr
PS
Wyeth Ayerst
Laboratories
ORAL
Route
Duration
ORAL
Methylphenidate
(Methylphenidate,)
SS
Date:08/13/01ISR Number: 3776024-4Report Type:Expedited (15-DaCompany Report #PHEH2001US06527
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Murder
Consumer
Ritalin Tab
PS
Novartis
Pharmaceuticals Corp
Prozac (Fluoxetine
Hydrochloride)
SS
Duration
Date:08/14/01ISR Number: 3777337-2Report Type:Expedited (15-DaCompany Report #MPI-2001-05948 (0)
Age:16 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Delusion Of Reference
Depressed Mood
Foreign
Literature
Methylphenidate Hcl
PS
Celltech
Manufacturing Inc
Depression
Health
Persecutory Delusion
Schizophreniform Disorder
Professional
Product
Role
Manufacturer
Concerta All
Strengths Alza
PS
Alza
Route
Duration
10MG DAY IN
AM
Date:08/15/01ISR Number: 3777453-5Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Duration
Drug Effect Decreased
Medication Error
Route
Date:08/16/01ISR Number: 3779010-3Report Type:Expedited (15-DaCompany Report #MPU-2001-00393 (0)
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Electrocardiogram Qt
Prolonged
Foreign
Other
Methylphenidate Hcl
PS
Celltech
Manufacturing Inc
Product
Role
Manufacturer
Concerta
PS
Alza
Ativan
SS
Mylan
Route
Duration
10 MG THREE
TIMES A DAY
Date:08/20/01ISR Number: 3779881-0Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #USP 081460
Report Source
Duration
Medication Error
TABLET,
EXTENDED
RELEASE
TABLET
18-Aug-2005
Page: 188
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/20/01ISR Number: 3780626-9Report Type:Expedited (15-DaCompany Report #PHBS2001CH08192
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Platelet Aggregation
Decreased
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Duration
20 MG/DAY,
Professional
ORAL
Other
Date:08/20/01ISR Number: 3780651-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB02271
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Attention
Deficit/Hyperactivity
Foreign
Health
Ritalin
PS
Novartis
Pharmaceuticals Corp
ORAL
Disorder
Professional
Condition Aggravated
Drug Interaction
Other
Duration
5 MG, BID,
ORAL
Clarityn
(Loratadine)
SS
ORAL
ORAL
Date:08/20/01ISR Number: 3780811-6Report Type:Expedited (15-DaCompany Report #2001-08-0812
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Attention
Deficit/Hyperactivity
Foreign
Health
Claritin
PS
Schering Corp Sub
Schering Plough Corp
ORAL
Disorder
Professional
Ritalin Tablets
Condition Aggravated
Drug Interaction
Inhibition
Other
Duration
ORAL
5MG BID ORAL
SS
ORAL
Date:08/23/01ISR Number: 3782489-4Report Type:Direct
Age:41 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Company Report #
Report Source
Product
Role
Manufacturer
Route
Ritalin-Ciba-16 Sr
20mg Novartis
PS
Novartis
ORAL
Manufacturer
Route
Duration
Agitation
Cognitive Disorder
SR 20MG/ONCE
Decreased Appetite
IN/ORAL
Insomnia
Motor Dysfunction
Paranoia
Speech Disorder
Date:08/27/01ISR Number: 3783487-7Report Type:Expedited (15-DaCompany Report #MPU-2001-00412(0)
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
2.5 MG THREE
TIMES DAILY,
PO
18-Aug-2005
Page: 189
11:49 AM
PT
Report Source
Product
Role
Face Oedema
Tongue Oedema
Foreign
Equasym
5mg(Methylphenidate
Hydrochloride Usp
5mg)
PS
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/27/01ISR Number: 3783538-XReport Type:Expedited (15-DaCompany Report #MPI-2001-05758 (0)
Age:
Gender:Female
I/FU:I
Outcome
Dose
Death
Disability
Other
PT
Report Source
Product
Abnormal Behaviour
Anxiety
Completed Suicide
Depression
Drug Dependence
Injury
Pain
Personality Change
Consumer
Other
Methylphenidate
Tablets
(Unspecified)
(Methylpheniate
Metadate Er Tablets
(Strength
Unspecified)
(Methylphenidate
Hydrochloride
Ritalin
(Methylphenidate
Hydrochloride)
Methylphenidate
Sustained Release
Methylin
Methylin Er
Prozac (Fluoxetine
Hydrochloride)
Date:09/04/01ISR Number: 3787992-9Report Type:Direct
Age:43 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG 4 AM
250 MG
Manufacturer
Route
PT
Route
PS
SS
SS
SS
SS
SS
SS
Company Report #
Report Source
Product
Role
Manufacturer
Concerta 18mg Alza
PS
Alza
Cephalexin 250 Mg
Teva 1 Qid
SS
Teva
Vicodin
C
Duration
Insomnia
1 QID
Date:09/04/01ISR Number: 3791056-8Report Type:Periodic
Age:20 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Role
Duration
Company Report #10776
PT
Report Source
Product
Convulsion
Health
Professional
Concerta
(Methylphenidate
Duration
Role
Manufacturer
Route
Company
Hcl)
PS
ORAL
18MG
Representative
1X/1DAY,ORAL
Date:09/04/01ISR Number: 3791057-XReport Type:Periodic
Age:14 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Company Report #10773
PT
Report Source
Product
Role
Tachycardia
Consumer
Concerta
(Methylphenidate
Hc1)
PS
Celexa
Wellbutrin Sr
C
C
54MG 1X/1DAY,
ORAL
Date:09/04/01ISR Number: 3791058-1Report Type:Periodic
Age:58 YR
Gender:Female
I/FU:I
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 190
11:49 AM
PT
Angina Pectoris
Chest Pain
Company Report #10777
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Laryngospasm
Malaise
Pain
Dose
Report Source
Product
Role
Consumer
Concerta
(Methylphenidate
Hc1)
PS
Premarin
Prilosec
Detrol
C
C
C
Manufacturer
Route
Duration
Palpitations
Ventricular Extrasystoles
ORAL
18MG 1X/1DAY,
ORAL
Date:09/05/01ISR Number: 3788578-2Report Type:Expedited (15-DaCompany Report #PHFR2001GB02434
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Chest Pain
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:09/05/01ISR Number: 3788583-6Report Type:Expedited (15-DaCompany Report #PHBS2001JP08737
Age:19 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Blood Creatine
Phosphokinase Increased
Convulsion
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
Depressed Level Of
Consciousness
Hyperthermia Malignant
Shock
Other
ORAL
Date:09/05/01ISR Number: 3788595-2Report Type:Expedited (15-DaCompany Report #PHNU2001DE01943
Age:18 YR
Gender:Male
I/FU:I
Manufacturer
Route
ORAL
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Blood Creatine
Phosphokinase Increased
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
ORAL
Ritaline
(Methylphenidate
Hydrocholride) Slow
Release Tablet
SS
ORAL
Duration
10 MG, BID,
ORAL
20
MG/DAY,ORAL
Date:09/06/01ISR Number: 3789771-5Report Type:Periodic
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 191
Company Report #260601
PT
Report Source
Product
Anxiety
Drug Interaction
Hyperhidrosis
Palpitations
Tachycardia
Health
Professional
Rocaltrol
(Calcitriol)
Concerta
(Methylphenidate
Hydrochloride)
Adderall
Role
Duration
11:49 AM
PS
SS
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
(Amphetamine
Aspartate/Amphetamin
e
Sulfate/Dextroamphet
Calcium (Calcium
Nos)
C
C
Date:09/07/01ISR Number: 3790162-1Report Type:Expedited (15-DaCompany Report #11308
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Dysphagia
Health
Professional
Other
Concerta
(Methylphenidate
Hcl)
PS
Wellbutrin
Depakote
C
C
Manufacturer
Route
Manufacturer
Route
Duration
36MG 1X/1DAY
ONE DOSE
Date:09/07/01ISR Number: 3790184-0Report Type:Expedited (15-DaCompany Report #10908
Age:5 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Psychomotor Hyperactivity
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Delsym
Ibuprofen
C
C
ORAL
18MG 1X/1DAY,
ORAL
Date:09/12/01ISR Number: 3791865-5Report Type:Direct
Age:43 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
5 AM
PT
Company Report #
Report Source
Product
Role
Manufacturer
Concerta 18 Mg, Alza
PS
Alza
Duration
Insomnia
Route
Cephalexin 250 Mg
Teva
SS
Vicodin
C
Teva
1 QID
Date:09/17/01ISR Number: 3793836-1Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #
Report Source
Product
Role
Manufacturer
Methylphenidate 5mg
Geneva
PS
Geneva
Methylphenidate 10mg
Geneva
SS
Geneva
Allegra
Advair
Flonase
C
C
C
Duration
Drug Effect Decreased
1 TID 047
1 TID 047
Date:09/17/01ISR Number: 3794516-9Report Type:Expedited (15-DaCompany Report #PHBS2001JP09045
Age:80 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 192
PT
Blood Creatine
Phosphokinase Increased
Depressed Level Of
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Consciousness
Pyrexia
Urinary Tract Infection
Dose
Report Source
Product
Role
Foreign
Health
Professional
Other
Ritaline(Methylpheni
datate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
10 MG/D, ORAL
Bufferin (Aluminium
Glycinate, Magnesium
Carbonate)
Mexitil (Mexdiletine
Hydrochloride)
Adalat Xl
C
C
C
Date:09/18/01ISR Number: 3795191-XReport Type:Expedited (15-DaCompany Report #2001065051US
Age:9 YR
Gender:Male
I/FU:F
Outcome
PT
Dose
Duration
Life-Threatening
Pituitary Tumour
Hospitalization Initial or Prolonged
Disability
Other
Required
15 MG, QD,
1203 DAY
Intervention to
Prevent Permanent
500 M G, QD,
Impairment/Damage
Report Source
Product
Study
Health
Professional
Genotropin
(Somatropin) Powder,
Sterile
Cortef
(Hydrocortisone)
Tablet
Role
Manufacturer
Route
Manufacturer
Route
PS
SS
Tegretol
(Carbamazepine)
SS
Ritalin
(Methylphenidate
Hydrochloride)
SS
25 MG, QD,
Date:09/19/01ISR Number: 3795135-0Report Type:Direct
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Concerta 36 Mg
PS
Duration
Face Oedema
36 MG + PO Q
Company Report #
ORAL
DAY
Date:09/21/01ISR Number: 3797420-5Report Type:Expedited (15-DaCompany Report #HQ6112118SEP2001
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Clonic Convulsion
Drug Interaction
Loss Of Consciousness
Health
Professional
Company
Representative
Effexor Xr
(Venlafaxine
Hydrochloride,
Capsule, Extended
Release)
PS
ORAL
Klonopin
(Clonazepam)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
Duration
150 MG 3X PER
1 DAY, ORAL
SEE IMAGE
SEE IMAGE
18-Aug-2005
Page: 193
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/24/01ISR Number: 3797912-9Report Type:Expedited (15-DaCompany Report #MPI-2001-05988(0)
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Laboratory Test Abnormal
Syncope
Health
Professional
Methylphenidate
Tablets 10mg
(Methylphenidate
Hydrochloride 10mg)
PS
Manufacturer
Route
10MG
Date:09/24/01ISR Number: 3798375-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB02434
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Chest Pain
Medication Error
Stomach Discomfort
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Novartis
Pharmaceuticals
Corp.
ORAL
Manufacturer
Route
Duration
20 MG, BID,
ORAL
Date:09/28/01ISR Number: 3802102-7Report Type:Expedited (15-DaCompany Report #PHBS2001NZ09415
Age:18 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Anaphylactoid Reaction
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Unknown
PS
Duration
50 MG/DAY,
ORAL
Date:09/28/01ISR Number: 3802671-7Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Company Report #2000UW03120
ORAL
Outcome
Dose
Duration
Hospitalization 50 MG QAM PO
Initial or Prolonged
25 MG PO
Required
75 MG HS PO
Intervention to
50 MG QAM PO
Prevent Permanent
10 MG QID
Impairment/Damage
30 MG BID
PT
Report Source
Product
Role
Manufacturer
Route
Priapism
Health
Seroquel
PS
ORAL
Professional
Seroquel
SS
ORAL
Seroquel
SS
ORAL
Seroquel
SS
ORAL
Ritalin
SS
Ritalin
SS
Ritalin
SS
Lithium
C
20 MG BID
Date:10/01/01ISR Number: 3802601-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB02623
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Neutropenia
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
PS
25 MG, TID,
Other
ORAL
18-Aug-2005
Page: 194
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/01/01ISR Number: 3802743-7Report Type:Expedited (15-DaCompany Report #FLUV00301003977
Age:30 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Death
Life-Threatening
PT
Report Source
Product
Role
Manufacturer
Route
Cerebral Infarction
Depressed Level Of
Consciousness
Foreign
Health
Professional
Luvox 25
(Fluvoxamine
Maleate)
PS
ORAL
Drug Toxicity
Other
Toledomin
(Milnacipran)
SS
ORAL
Amoxan (Amoxapine)
SS
ORAL
Paxil (Paroxetine
Hydrochloride)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
Rize (Clotiazepam)
Solanax (Alprazolam)
C
C
50 MG DAILY
PO
Neuroleptic Malignant
Syndrome
150 MG DAILY
Pupils Unequal
PO
Renal Failure Acute
300 MG DAILY
PO
10 MG DAILY
PO
10 MG DAILY
PO
Date:10/04/01ISR Number: 3806044-2Report Type:Expedited (15-DaCompany Report #11308
Age:16 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Dysphagia
Foreign Body Trauma
Health
Professional
Other
Concerta
(Methylphenidate
Hcl)
PS
Wellbutrin
Depakote
C
C
Duration
36 MG 1X/DAY
Manufacturer
Route
Date:10/05/01ISR Number: 3805407-9Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Manufacturer
Metadate Cd
(Methylphenidate
Hydrochloride)
Capsule, Extended
Release
Metadate Er
(Methylphenidate
Hydrochloride)
Extended Release
PS
Celltech
SS
Medeva
Pharmaceuticals
Manufacturer
Route
Duration
Medication Error
Date:10/10/01ISR Number: 3807021-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB02702
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Route
Condition Aggravated
Impulsive Behaviour
Increased Appetite
Foreign
Health
Professional
Ritaline
(Methylphenidat
20+20+15 Mg/Day
PS
ORAL
Psychomotor Hyperactivity
Other
Clarityn
(Loratadine)
SS
ORAL
Duration
20+20+15MG
/DAY,ORAL
10 MG/DAY,
ORAL
18-Aug-2005
Page: 195
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/10/01ISR Number: 3807028-0Report Type:Expedited (15-DaCompany Report #PHNU2001DE02264
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Aplastic Anaemia
Neutrophil Count
Decreased
Platelet Count Decreased
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
10 MG, DU,
Skin Discolouration
ORAL
White Blood Cell Count
Decreased
Date:10/11/01ISR Number: 3807714-2Report Type:Direct
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Manufacturer
Methylphenidate -(10
Mg) (Shein)
PS
Shein
Methylphenidate(10mg
)(Mallinolsudt)
SS
Mallinolsudt
Manufacturer
Route
Duration
Aggression
Educational Problem
20MG -20MG
Impulse-Control Disorder
-10
20MG-20MG-10
Date:10/12/01ISR Number: 3809379-2Report Type:Expedited (15-DaCompany Report #MPI-2001-05774 (1)
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Aggression
Feeling Abnormal
Obsessive-Compulsive
Disorder
Foreign
Literature
Health
Professional
Methylphenidate
Tablets 20 Mg
(Methylphenidate
Hydrochloride 20 Mg)
PS
Imipramine
(Imipramine)
C
Route
Duration
40MG, BID, PO
Tic
ORAL
Date:10/15/01ISR Number: 3809541-9Report Type:Expedited (15-DaCompany Report #11308
Age:16 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Dysphagia
Foreign Body Trauma
Health
Professional
Other
Concerta
(Methylphenidate
Hcl)
PS
Wellbutrin
Depakote
Clonidine
Stimulants (Nos)
C
C
C
C
Manufacturer
Route
Manufacturer
Route
Duration
36MG 1X/1DAY
Date:10/16/01ISR Number: 3810291-3Report Type:Expedited (15-DaCompany Report #PHBS2001CA09991
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
Disability
18-Aug-2005
Page: 196
11:49 AM
PT
Report Source
Product
Role
Compartment Syndrome
Muscle Disorder
Foreign
Consumer
Other
Ritaline
(Methylphenidate
Hydrochloride)
PS
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/16/01ISR Number: 3810623-6Report Type:Expedited (15-DaCompany Report #PHEH2001US08070
Age:45 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Ammonia Increased
Asthenia
Blood Creatinine
Study
Health
Professional
Ritalin(Methylphenid
ate Hydrochloride)
Gleevec
PS
SS
Manufacturer
Route
ORAL
100 MG, QD,
Increased
ORAL
Blood Urea Increased
Coordination Abnormal
Creatine Urine Increased
Fatigue
Gait Disturbance
Lethargy
Sedation
Ambien(Zolpidem
Tartrate)
Ibuprofen
(Ibuprofen)
Morphine
Sulfate(Morphine
Sulfate)
Oxycodone(Oxycodone)
Bromfed
(Brompheniramine
Maleate)
Centrum(Vitamin Nos)
Chlorpromazine
(Chlorpromazine)
Spironolactone
SS
SS
SS
SS
C
C
C
C
Date:10/18/01ISR Number: 3811406-3Report Type:Expedited (15-DaCompany Report #PHNU2001DE02288
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Aggression
Delusion
Hallucination
Obsessive-Compulsive
Foreign
Health
Professional
Company
Ritaline
(Methylphenidate
Hydrochloride)
Sugar-Coated Tablet
PS
Disorder
Representative
Manufacturer
Route
Duration
25 MG/DAY,
ORAL
Other
Date:10/18/01ISR Number: 3811619-0Report Type:Expedited (15-DaCompany Report #PHEH2001US07958
Age:48 YR
Gender:Female
I/FU:I
ORAL
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Pressure Increased
Thyroid Neoplasm
Health
Professional
Ritalin
(Methylphenidat
Hydrochloride)
Tablet, 5 Mg
PS
Manufacturer
Route
Duration
ORAL
5 MG, QID,
ORAL
Date:10/22/01ISR Number: 3813504-7Report Type:Expedited (15-DaCompany Report #HQ7290318OCT2001
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Drug Interaction
Neuroleptic Malignant
Syndrome
Health
Professional
Company
Representative
Effexor Xr
(Venlafaxine
Hydrochloride,
Capsule,
PS
Methylphenidate
(Methylphenidate)
SS
ORAL
18-Aug-2005
Page: 197
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/23/01ISR Number: 3813651-XReport Type:Expedited (15-DaCompany Report #HQ7334618OCT2001
Age:16 YR
Gender:
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Completed Suicide
Intentional Misuse
Literature
Hydroxyzine Hcl
(I.M.) (Hydroxyzine
Hydrochloride,
Injection)
PS
Amitriptyline
(Amitriptyline, )
SS
ORAL
Methypenidate
Hydrochloride
(Methylpenidate
Hydrochloride, )
SS
ORAL
Route
Duration
OVERDOSE
AMOUNT
UNKNOWN
OVERDOSE
AMOUNT
UNKNOWN, ORAL
OVERDOSE
AMOUNT
UNKNOWN, ORAL
Date:10/31/01ISR Number: 3818201-XReport Type:Expedited (15-DaCompany Report #PHNU2001DE02290
Age:20 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abortion
Complications Of Maternal
Exposure To Therapeutic
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Drugs
Other
Manufacturer
Route
Duration
30-40MG/DAY,
ORAL
Psoriasis
ORAL
Date:10/31/01ISR Number: 3818202-1Report Type:Expedited (15-DaCompany Report #PHNU2001DE02288
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Acrophobia
Delusion
Hallucination
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Sugar-Coated Tablet
PS
ORAL
Obsessive-Compulsive
Company
Disorder
Representative
Other
Fenistil(Dimetindene
Maleate)
SS
ORAL
Cortisone(Cortisone)
Spray
SS
Duration
20 MG/DAY,
ORAL
ORAL
RESPIRATORY
(INHALATION)
INHALATION
Date:10/31/01ISR Number: 3818754-1Report Type:Expedited (15-DaCompany Report #99CDN10751
Age:7 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Compartment Syndrome
Muscle Disorder
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
ORAL
Ritalin-Sr
(Metyhylphenidate
Hydrochloride) Slow
Release Tablet, 20
Mg
SS
ORAL
15 MG, BID,
ORAL
20 MG, QD,
18-Aug-2005
Page: 198
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
ORAL
Date:11/01/01ISR Number: 3819864-5Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
5MG TID ORAL
Hospitalization Initial or Prolonged
PT
Product
Role
Supraventricular
Methylphenidate 5mg
PS
Tachycardia
Celexa
C
Date:11/01/01ISR Number: 3819895-5Report Type:Direct
Age:15 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
15 MG PO Q AM
Company Report #
PT
Report Source
Manufacturer
Route
ORAL
Company Report #
Report Source
Drug Ineffective
Product
Role
Ritalin
PS
Manufacturer
Route
ORAL
Date:11/02/01ISR Number: 3820193-4Report Type:Expedited (15-DaCompany Report #PHNU2001DE02485
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Ventricular Extrasystoles
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
10 MG, QID,
ORAL
Date:11/07/01ISR Number: 3822082-8Report Type:Expedited (15-DaCompany Report #A044-002-003326
Age:72 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Hospitalization SEE IMAGE
Initial or Prolonged
SEE IMAGE
Drug Interaction
Foreign
Aricept (Donepezil)
PS
ORAL
Posture Abnormal
Health
Zyprexa (Olanzapine)
SS
ORAL
Professional
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
SEE IMAGE
Thrombran (Trazodone
Hydrochloride)
Ass (Acetylsalicylic
Acid)
Date:11/07/01ISR Number: 3824092-3Report Type:Expedited (15-DaCompany Report #2001-10-1935
Age:66 YR
Gender:Male
I/FU:I
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 199
11:49 AM
PT
Atelectasis
Decreased Appetite
Demyelinating
Polyneuropathy
Difficulty In Walking
Drug Interaction
Dysphagia
Faecal Incontinence
Guillain-Barre Syndrome
Haemoglobin Decreased
Joint Stiffness
Metabolic Acidosis
Muscular Weakness
C
C
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Nervous System Disorder
Neuropathy Peripheral
Oral Candidiasis
Report Source
Product
Role
Oxygen Saturation
Decreased
Platelet Count Decreased
Study
Health
Professional
Intron A (Interferon
Alfa-2b Recombinant)
Injectable
PS
Pneumonia
Other
Ritalin Blinded
Study
SS
Manufacturer
Route
Duration
SUBCUTANEOUS
10 MU
SUBCUTANEOUS;
Renal Cyst
6 MU
Urinary Incontinence
SUBCUTANEOUS
Weight Decreased
ORAL
ORAL
Lipitor
(Atorvastatin)
Prilosec
Lasix
Glucophage
Micronase
K-Dur (Potassium
Chloride)
Inderal
Zyloprim
Multivitamins
Tylenol
C
C
C
C
C
C
C
C
C
C
Date:11/08/01ISR Number: 3822918-0Report Type:Expedited (15-DaCompany Report #PHBS2001CH10815
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Anxiety
Chest Pain
Confusional State
Dyspnoea
Foreign
Health
Professional
Other
Ritalin-Sr
(Methylphenidate
Hydrochloride) Slow
Release Tablet
PS
10 TO 20
Hallucination
MG/DAY, ORAL
Hyperhidrosis
Palpitations
Psychotic Disorder
Manufacturer
Route
ORAL
Syncope
Date:11/13/01ISR Number: 3824180-1Report Type:Direct
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
5MG 1 QD M-F
PT
Company Report #
Report Source
Drug Ineffective
Product
Role
Manufacturer
Ritalin Generic
PS
Generic
Role
Manufacturer
Route
Fatigue
Date:11/13/01ISR Number: 3824766-4Report Type:Expedited (15-DaCompany Report #PHBS2001US11161
Age:39 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Depression
Drug Dependence
Literature
Consumer
Ritaline
(Methylphenidate
Hydrochloride)
Oxycontin (Oxycodone
Hydrochloride)
Tablet
PS
SS
ORAL
Percocet (Oxycodone
Hydrochloride,
Paracetamol)
18-Aug-2005
Page: 200
Route
Duration
11:49 AM
SS
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/13/01ISR Number: 3824839-6Report Type:Expedited (15-DaCompany Report #96USA13341
Age:20 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Overdose
Schizophrenia, Paranoid
Type
Suicidal Ideation
Health
Professional
Ritalin-Sr
(Methylphenidate
Hydrochloride) Slow
Release Tablet
PS
Paxil (Paroxetine
Hydrochloride)
Tablet
C
Manufacturer
Route
ORAL
ORAL
Date:11/13/01ISR Number: 3825469-2Report Type:Expedited (15-DaCompany Report #96USA13562
Age:20 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
ORAL
364
PT
Report Source
Product
Role
Intentional Misuse
Suicide Attempt
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Paxil (Paroxetine
Hydrochloride)
C
Manufacturer
Route
ORAL
DAY
Date:11/13/01ISR Number: 3826153-1Report Type:Expedited (15-DaCompany Report #PHNU2001DE02553
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Pleurothotonus
Foreign
Study
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
ORAL
Other
Zyprexa (Olanzapine)
SS
ORAL
Aricept (Donepezil
Hydrochloride)
SS
ORAL
SEE IMAGE
SEE IMAGE
SEE IMAGE
Thombran (Trazodone
Hydrochloride)
Acetylsalicylate
Date:11/14/01ISR Number: 3823926-6Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
C
C
Company Report #
Report Source
Product
Role
Methylphenidate (5
Mg)
PS
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
5 MG Q AM &
2.5 MG Q PM
Date:11/16/01ISR Number: 3825932-4Report Type:Expedited (15-DaCompany Report #PHNU2001DE02393
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 30MG/DAY,
Initial or Prolonged
ORAL
PT
Report Source
Product
Role
Eosinophilia
Foreign
Ritaline
PS
Health
Professional
Other
18-Aug-2005
Page: 201
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/16/01ISR Number: 3827521-4Report Type:Expedited (15-DaCompany Report #PHEH2001US09161
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Haematochezia
Consumer
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
Date:11/16/01ISR Number: 3827883-8Report Type:Expedited (15-DaCompany Report #PHEH2001US09260
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Accidental Overdose
Medication Error
Consumer
Health
Professional
Methyphenidate
(Methylphenidate
Hydrochloride)
Tablet
Methadone
(Methadone)
Role
Duration
PS
SS
Date:11/19/01ISR Number: 3827316-1Report Type:Expedited (15-DaCompany Report #HQ6112118SEP2001
Age:41 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Clonic Convulsion
Drug Interaction
Loss Of Consciousness
Health
Professional
Company
Representative
Effexor Xr
(Venlafaxine
Hydrochloride,
Capsule, Extended
Release)
PS
ORAL
Klonopin
(Clonazepam)
SS
ORAL
Duration
150 MG 3X PER
1 DAY, ORAL
0.5 MG 1X PER
1 DAY, ORAL;
1 MG 1X PER 1
DAY, ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
20 MG 3X PER
1 DAY, ORAL
Date:11/20/01ISR Number: 3827907-8Report Type:Expedited (15-DaCompany Report #PHNU2001DE02391
Age:63 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Agitation
Amnestic Disorder
Cerebral Ischaemia
Confusional State
Foreign
Health
Professional
Other
Ritaline
(Methylphenidat
Hydrochloride)
Tablet
PS
20 MG/DAY,
Disorientation
ORAL
Malaise
Memory Impairment
Pyrexia
Simple Partial Seizures
Vasculitis Cerebral
Vasospasm
18-Aug-2005
Page: 202
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/20/01ISR Number: 3828074-7Report Type:Expedited (15-DaCompany Report #PHNU2001DE02641
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Difficulty In Walking
Paraesthesia
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
10 MG, BID,
ORAL
Date:11/21/01ISR Number: 3827119-8Report Type:Expedited (15-DaCompany Report #D0022804A
Age:43 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
800MG per day
PT
Report Source
Product
Role
Manufacturer
Route
Bowel Sounds Abnormal
Coma
Zyban
Amphetamine Sulphate
PS
SS
Glaxo Wellcome
ORAL
ORAL
Drug Toxicity
Ritalin
SS
ORAL
Fatigue
Wine
SS
ORAL
60MG per day
3BT per day
Suicide Attempt
Tachycardia
Date:11/21/01ISR Number: 3829479-0Report Type:Expedited (15-DaCompany Report #MPI-2001-06087
Age:36 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
40 MG
PT
Report Source
Product
Role
Dyskinesia
Tic
Health
Professional
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride
Extended-Release
PS
Duration
Manufacturer
Route
Date:11/21/01ISR Number: 3829526-6Report Type:Expedited (15-DaCompany Report #MPI-2001-06089(0)
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Anger
Depression
Social Avoidant Behaviour
Suicidal Ideation
Health
Professional
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride
Extended-Release
PS
Benadryl
(Diphenhydramine
Hydrochloride)
C
Manufacturer
Route
Manufacturer
Route
Duration
20 MG OR 40MG
Date:11/23/01ISR Number: 3829120-7Report Type:Expedited (15-DaCompany Report #PHNU2001DE01943
Age:18 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Creatine
Phosphokinase Increased
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
ORAL
Rtaline
(Methylphenidate
Hydrochloride) Slow
Release Tablet
SS
ORAL
Duration
ORAL
ORAL
18-Aug-2005
Page: 203
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/23/01ISR Number: 3829381-4Report Type:Expedited (15-DaCompany Report #11775
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Gastric Ulcer
Consumer
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Manufacturer
Route
Duration
ORAL
18MG 1X/1DAY,
ORAL
Date:11/27/01ISR Number: 3830985-3Report Type:Direct
Age:15 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Methylphenidate
Ritalin 20mg
PS
C
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
Date:11/27/01ISR Number: 3832629-3Report Type:Direct
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
Required
15-17 TABLE
Intervention to
PER DAY ORAL
Prevent Permanent
Impairment/Damage
PT
Company Report #
Report Source
Medication Error
Product
Ritalin
Tablets
Role
10 Mg
PS
ORAL
Date:11/28/01ISR Number: 3831419-5Report Type:Expedited (15-DaCompany Report #2001UW14835
Age:47 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization 50 MG BID PO
PT
Report Source
Product
Role
Accidental Overdose
Other
Seroquel
PS
Manufacturer
Route
ORAL
Initial or Prolonged
A FEW YEARS
Blood Creatine
Phosphokinase Increased
Seroquel
SS
ORAL
Phosphokinase Mb
Gabitril
SS
ORAL
Increased
Paxil
SS
ORAL
Complex Partial Seizures
Ritalin
SS
ORAL
Delirium
Faecal Incontinence
Grand Mal Convulsion
Leukocytosis
Major Depression
Mental Impairment
Migraine
Urinary Incontinence
White Blood Cell Count
Increased
Lamictal
Biaxin
Neurontin
Zomig
Imitrex
"Glaxo-Wellcome"
Ranitidine
Remeron
Synthroid
C
C
C
C
500 MG HS PO
Blood Creatine
A FEW YEARS
14 MG QD PO
30 MG QD PO
20 MG QID PO
Date:11/28/01ISR Number: 3844334-8Report Type:Periodic
Age:37 YR
Gender:Female
I/FU:I
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 204
11:49 AM
PT
Crying
Depression
Feeling Abnormal
Hypoaesthesia
Hypoaesthesia Oral
Sedation
Company Report #A0160503A
C
C
C
C
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Suicide Attempt
Dose
Report Source
Product
Role
Consumer
Wellbutrin Sr
Tablet-Controlled
Release (Bupropion
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
150 MG /
TWICE PER DAY
/ ORAL
Paracetamol
(Formulation
Unknown)
(Acetaminophen)
Sertraline
Hydrochloride
(Formulation
Unknown) (Sertraline
Hydrochloride)
SS
SS
100 MG / PER
DAY
Methylphenidate Hc1
(Formulation
Unknown)
(Methylphenidate
Hcl)
SS
Disulfiram
(Formulation
Unknown)
(Disulfiram)
SS
Lorazepam
(Formulation
Unknown) (Lorazepam)
SS
20 MG
250 MG / PER
DAY
5 MG / AS
REQUIRED /
ORAL
ORAL
Date:11/29/01ISR Number: 3832143-5Report Type:Expedited (15-DaCompany Report #PHNU2001DE02716
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Diplopia
Strabismus
Foreign
Health
Professional
Ritaline(Methylpheni
date
Hydrochloride)Tablet
PS
Manufacturer
Route
ORAL
20MG/DAY,
Other
ORAL
Date:11/29/01ISR Number: 3832509-3Report Type:Expedited (15-DaCompany Report #PHBS2001DK11767
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Atrial Fibrillation
Syncope
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
30 MG/DAY
Other
18-Aug-2005
Page: 205
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/29/01ISR Number: 3832525-1Report Type:Expedited (15-DaCompany Report #PHNU2001DE00522
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Activated Partial
Thromboplastin Time
Prolonged
Coagulation Factor
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
30 MG/DAY,
Decreased
ORAL
Factor Ix Deficiency
Date:11/29/01ISR Number: 3832526-3Report Type:Expedited (15-DaCompany Report #PHNU2001DE02710
Age:39 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Aphasia
Blood Immunoglobulin G
Increased
Cerebral Artery
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
20-30 MG/DAY,
Thrombosis
ORAL
Cerebrovascular Accident
Hemiparesis
Vasculitis Cerebral
Date:11/29/01ISR Number: 3832543-3Report Type:Expedited (15-DaCompany Report #PHRM2001FR02590
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
15 MG/DAY,
ORAL
PT
Report Source
Product
Role
Hyperaemia
Pain
Pain In Extremity
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
Date:11/29/01ISR Number: 3832552-4Report Type:Expedited (15-DaCompany Report #PHBS2001JP09045
Age:80 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Depressed Level Of
Consciousness
Neuroleptic Malignant
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
Syndrome
Other
Manufacturer
Route
ORAL
10 MG/DAY,
ORAL
Urinary Tract Infection
White Blood Cell Count
Increased
Bufferin (Aluminium
Glycinate, Magnesium
Carbonate)
Mexetil (Mexilentine
Hydrochloride)
Adalat Xl
Date:11/29/01ISR Number: 3837056-0Report Type:Periodic
Age:47 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization 2 MG QD ORAL
Initial or Prolonged
16 MG QD ORAL
C
C
C
Company Report #US009033
PT
Report Source
Product
Role
Manufacturer
Route
Accidental Overdose
Health
Gabitril
PS
ORAL
Complex Partial Seizures
Professional
Gabitril
SS
ORAL
Faecal Incontinence
Company
Gabitril
SS
ORAL
Urinary Incontinence
Representative
Seroquel
SS
ORAL
16 MG QD ORAL
50 MG BID
ORAL
A FEW
18-Aug-2005
Page: 206
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
YEARS
Seroquel
SS
ORAL
Ritalin
SS
ORAL
Paxil
SS
ORAL
Lamictal
Biaxin
Neurontin
Zomig
Imitrex
Ranitidine
Remeron
Synthroid
C
C
C
C
C
C
C
C
500 MG QHS
ORAL
A FEW
YEARS
20 MG QID
ORAL
30 MG DAILY
ORAL
Glaxo-Welcome
Date:11/30/01ISR Number: 3833165-0Report Type:Expedited (15-DaCompany Report #PHNU2001DE02711
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Chills
Diplopia
Dyskinesia
Oculogyration
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
ORAL
Strabismus
Date:12/03/01ISR Number: 3833892-5Report Type:Expedited (15-DaCompany Report #PHNU2001DE02391
Age:63 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Agitation
Amnestic Disorder
Foreign
Health
Ritaline
(Methylphenidate
Role
Manufacturer
Route
Cerebral Ischaemia
Confusional State
Professional
Other
Hydrochloride)
Tablet
PS
ORAL
200 MG/DAY,
Disorientation
ORAL
Memory Impairment
Nervous System Disorder
Pyrexia
Simple Partial Seizures
Vasculitis Cerebral
Vasospasm
Date:12/03/01ISR Number: 3844166-0Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #11437
PT
Report Source
Product
Role
Agitation
Anxiety
Personality Disorder
Consumer
Concerta
(Methylphenidate
Hcl)
PS
Prozac
C
18MG 1X/DAY,
ORAL
18-Aug-2005
Page: 207
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/04/01ISR Number: 3834953-7Report Type:Expedited (15-DaCompany Report #MPI-2001-06121 (0)
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
20MG QD
PT
Report Source
Product
Role
Aggression
Homicidal Ideation
Health
Professional
Metadate Cd Capsule
20 Mg
(Methylphenidate
Hydrochloride
Extended-Release
PS
Manufacturer
Route
Duration
ORAL
PO
Date:12/06/01ISR Number: 3836979-6Report Type:Expedited (15-DaCompany Report #PHBS2001CA03983
Age:
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Anorexia
Weight Decreased
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
Trazodone
(Trazodone)
C
Manufacturer
Route
Duration
ORAL
20 MG/DAY,
Other
ORAL
Date:12/06/01ISR Number: 3837293-5Report Type:Expedited (15-DaCompany Report #PHNU2001DE02711
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Chills
Diplopia
Dyskinesia
Oculogyration
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
ORAL
Strabismus
Date:12/06/01ISR Number: 3837306-0Report Type:Expedited (15-DaCompany Report #PHNU2001DE02753
Age:30 YR
Gender:Male
I/FU:I
Manufacturer
Route
ORAL
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Cerebral Venous
Thrombosis
Headache
Product
Role
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Marcumar
(Phenprocoumon)
C
Manufacturer
Route
ORAL
ORAL
Date:12/06/01ISR Number: 3837308-4Report Type:Expedited (15-DaCompany Report #PHNU2001DE02785
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Bleeding Time Prolonged
Oedema Peripheral
Platelet Disorder
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
ORAL
Date:12/07/01ISR Number: 3837529-0Report Type:Expedited (15-DaCompany Report #MPI-2001-06089(1)
Age:10 YR
Gender:Male
I/FU:F
Outcome
Other
18-Aug-2005
Page: 208
Manufacturer
Route
Duration
PT
Anger
Depression
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Educational Problem
Irritability
Personality Change
Report Source
Product
Role
Social Avoidant Behaviour
Suicidal Ideation
Health
Professional
Metadate Cd Capsules
20mg
(Methylphenidate
Hydrochloride
Extended-Release
PS
Benadryl
(Diphenhydramine
Hydrochloride)
C
Manufacturer
Route
Duration
ORAL
20 MG QAM PO
Date:12/07/01ISR Number: 3837533-2Report Type:Expedited (15-DaCompany Report #MPI-2001-06106 (0)
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Aggression
Agitation
Belligerence
Delusion
Depression
Health
Professional
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride
Extended-Release
PS
Depakote (Valproate
Semisodium)
C
Manufacturer
Route
Duration
ORAL
20 MG QAM PO
Hallucination, Auditory
Negativism
Psychotic Disorder
Social Avoidant Behaviour
Suicidal Ideation
Date:12/10/01ISR Number: 3837493-4Report Type:Expedited (15-DaCompany Report #PHBS2001NZ12212
Age:24 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Drug Dependence
Medication Error
Oedema Peripheral
Foreign
Literature
Health
Methylphenidate
(Methylphenidate
Hydrochloride)
PS
Skin Discolouration
Professional
Other
INJECTION NOS
Manufacturer
Route
Date:12/10/01ISR Number: 3839244-6Report Type:Expedited (15-DaCompany Report #PHBS2001NZ12213
Age:42 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Drug Abuser
Erythema
Groin Pain
Foreign
Literature
Health
Methylphenidate
(Methylphenidate
Hydrochloride)
PS
Inguinal Mass
Medication Error
Oedema Peripheral
Pitting Oedema
Sepsis
Vascular Pseudoaneurysm
Professional
Other
INJECTION,NOS
Date:12/11/01ISR Number: 3838344-4Report Type:Expedited (15-DaCompany Report #PHEH2001US09873
Age:17 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 209
PT
Growth Retardation
Mentally Late Developer
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Underweight
Dose
Report Source
Product
Role
Consumer
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Manufacturer
Route
Duration
Date:12/12/01ISR Number: 3839057-5Report Type:Direct
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
15MG-10MG-10M
PT
Company Report #
Report Source
Drug Effect Decreased
Product
Role
Ritalin Generic
PS
ORAL
G ORAL LACK
OF EFFECT
Date:12/12/01ISR Number: 3839425-1Report Type:Expedited (15-DaCompany Report #PHNU2001DE02819
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hallucination, Auditory
Foreign
Health
Professional
Ritaline(Methyphenid
ate Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
15MG/DAY,
Other
ORAL
Date:12/12/01ISR Number: 3839772-3Report Type:Expedited (15-DaCompany Report #PHBS2001US12331
Age:
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Cardiac Arrest Neonatal
Coma
Literature
Health
Ritaline
(Methylphenidate
Duration
Role
Manufacturer
Route
TRANSPLACENTAL
Cyanosis Neonatal
TRANSPLACENTA
Hyporeflexia
Professional
Hydrocloride)
PS
Wellbutrin
(Amfebutamone
Hydrochloride)
SS
Benadryl
(Diphenhydramine
Hydrochloride)
SS
L
TRANSPLACENTAL
Hypotonia Neonatal
Maternal Drugs Affecting
Foetus
TRANSPLACENTA
Neonatal Apnoeic Attack
L
Oliguria
Tremor Neonatal
TRANSPLACENTAL
TRANSPLACENTA
L
Date:12/12/01ISR Number: 3839930-8Report Type:Expedited (15-DaCompany Report #PHRM2001FR02590
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
C-Reactive Protein
Increased
Hyperaemia
Hyperaesthesia
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
17.5 MG/DAY,
Pain
ORAL
Red Blood Cell
Sedimentation Rate
Increased
White Blood Cell Count
Increased
18-Aug-2005
Page: 210
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/12/01ISR Number: 3839931-XReport Type:Expedited (15-DaCompany Report #PHNU2001DE02391
Age:63 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Agitation
Amnestic Disorder
Cerebral Ischaemia
Confusional State
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
10 MG/DAY,
Disorientation
ORAL
Malaise
Memory Impairment
Nuclear Magnetic
Resonance Imaging
Abnormal
Pyrexia
Simple Partial Seizures
Vasculitis Cerebral
Vasospasm
Date:12/12/01ISR Number: 3839932-1Report Type:Expedited (15-DaCompany Report #PHBS2001NZ12212
Age:24 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Drug Abuser
Medication Error
Oedema Peripheral
Peripheral Ischaemia
Foreign
Literature
Health
Professional
Ritaline
(Methylpenidate
Hydrochloride)
Unknown
PS
Skin Discolouration
Other
Manufacturer
Route
Manufacturer
Route
INJECTION NOS
Date:12/12/01ISR Number: 3839945-XReport Type:Expedited (15-DaCompany Report #PHBS2001NZ12213
Age:42 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
INJECTION NOS
PT
Report Source
Product
Role
Drug Abuser
Erythema
Medication Error
Foreign
Literature
Health
Ritaline
(Methylphenidate
Hydrochloride)
PS
Mycotic Aneurysm
Necrosis
Oedema Peripheral
Pain
Pitting Oedema
Postoperative Infection
Sepsis
Vascular Pseudoaneurysm
Professional
Other
Date:12/13/01ISR Number: 3841455-0Report Type:Expedited (15-DaCompany Report #2001-10-1935
Age:66 YR
Gender:Male
I/FU:F
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 211
11:49 AM
PT
Blood Folate Abnormal
Csf Cell Count Abnormal
Csf Lymphocyte Count
Abnormal
Decreased Appetite
Demyelinating
Polyneuropathy
Difficulty In Walking
Dysphagia
Faecal Incontinence
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Guillain-Barre Syndrome
Haemoglobin Decreased
Joint Stiffness
Dose
Report Source
Product
Role
Study
Health
Professional
Intron A (Interferon
Alfa-2b Recombinant)
Injectable
PS
Pneumonia
Renal Cyst
Ritalin Blinded
Study
SS
Serum Ferritin Abnormal
Urinary Incontinence
Vitamin B12 Abnormal
Weight Decreased
White Blood Cell Count
Abnormal
Lipitor
(Atorvastatin)
Prilosec
Lasix
Glucophage
Micronase
K-Dur (Potassium
Chloride)
Inderal
Zyloprim
Multivitamins
Tylenol
Manufacturer
Route
Duration
Metabolic Acidosis
Metastasis
Muscular Weakness
10-6MU*
Oral Candidiasis
SUBCUTANEOUS
Other
SUBCUTANEOUS;
Oxygen Saturation
10 MU
Decreased
SUBCUTANEOUS;
Platelet Count Abnormal
6 MU
ORAL
5MG BID ORAL
C
C
C
C
C
C
C
C
C
C
Date:12/14/01ISR Number: 3841056-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB03375
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Cardiomegaly
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
PS
Duration
Manufacturer
Route
Date:12/17/01ISR Number: 3839983-7Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
20MG SR Q AM
PT
Company Report #
Report Source
Educational Problem
Product
Role
Ritalin (Generic)
PS
Ritalin(Generic)
SS
Manufacturer
Route
ORAL
Fight In School
ORAL
15MG REGULAR
PM
Date:12/18/01ISR Number: 3841893-6Report Type:Expedited (15-DaCompany Report #PHBS2001US12381
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Attention
Deficit/Hyperactivity
Disorder
Literature
Health
Professional
Methylphenidate
(Methylphenidate
Hydrochloride)
PS
Duration
10 MG, TID
Condition Aggravated
Depression
Hallucination, Auditory
Headache
Middle Insomnia
Nightmare
Psychotic Disorder
18-Aug-2005
Page: 212
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/19/01ISR Number: 3841595-6Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Ritalin
PS
Manufacturer
Route
Route
Duration
Drug Effect Decreased
Date:12/20/01ISR Number: 3843304-3Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Company Report #
PT
Company Report #
Report Source
Product
Role
Manufacturer
Ritalin (Novartis)
PS
Novartis
Product
Role
Manufacturer
Ritalin
PS
Duration
Drug Ineffective
10MG IN AM
Date:12/21/01ISR Number: 3843674-6Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
5 MG PM PO
PT
Company Report #
Report Source
Route
Duration
Unevaluable Event
ORAL
PRN
Date:12/21/01ISR Number: 3843679-5Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
5 MG TID PO
PT
Report Source
Product
Role
Ritalin 5 Mg
PS
Manufacturer
Route
Duration
Unevaluable Event
Date:12/21/01ISR Number: 3844008-3Report Type:Direct
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #
PT
Company Report #
Report Source
Product
Duration
Sedation
ORAL
Methylphenidate (5
Role
Manufacturer
Route
Mg) (Able
Laboratories)
PS
Able Laboratories
ORAL
Manufacturer
Route
7.5 MG BID
ORAL
Date:12/27/01ISR Number: 3845579-3Report Type:Expedited (15-DaCompany Report #MPI-2001-06344 (0)
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Required
Intervention to
Prevent Permanent
200 MG AT
Impairment/Damage
ONCE PO
PT
Report Source
Product
Role
Bruxism
Drug Ineffective
Feeling Hot
Insomnia
Medication Error
Health
Professional
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride
Extended-Release
PS
Ritalin
(Methylphenidate
Hydrochloride)
C
Muscle Twitching
Speech Disorder
Thinking Abnormal
Tremor
Date:12/28/01ISR Number: 3846028-1Report Type:Direct
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #157914
PT
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Health
Professional
Methylphenidate 5mg
Geneva
PS
Geneva
ORAL
Duration
7.5MG PO BID
18-Aug-2005
Page: 213
ORAL
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/28/01ISR Number: 3846480-1Report Type:Expedited (15-DaCompany Report #PHBS2001CH12577
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Hallucination, Tactile
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
15 MG/DAY,
Other
ORAL
Date:12/28/01ISR Number: 3846509-0Report Type:Expedited (15-DaCompany Report #PHNU2001DE02553
Age:72 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Dystonia
Foreign
Study
Health
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
ORAL
Professional
Zyprexa(Olanzapine)
SS
ORAL
Other
Aricept(Donepezil
Hydrochloride)
SS
ORAL
Thrombran(Trazodone
Hydrochloride)
Acetylsalicylate
C
C
SEE IMAGE
SEE IMAGE
SEE IMAGE
Date:12/28/01ISR Number: 3846524-7Report Type:Expedited (15-DaCompany Report #PHNU2001DE02819
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
15MG/DAY,
ORAL
PT
Report Source
Product
Role
Hallucination, Auditory
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
Date:12/31/01ISR Number: 3845997-3Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
5 MG TID PO
PT
Report Source
Product
Role
Affect Lability
Methylphenidate
PS
Affective Disorder
Drug Effect Decreased
Irritability
Pharmaceutical Product
Complaint
Risperdal
Clonidine
C
C
Route
PT
Report Source
Product
Role
Metadate Cd
PS
Duration
Medication Error
Date:01/03/02ISR Number: 3848170-8Report Type:Expedited (15-DaCompany Report #PHNU2001DE02753
Age:30 YR
Gender:Male
I/FU:F
Outcome
Hospitalization Initial or Prolonged
Other
11:49 AM
PT
Cerebral Venous
Thrombosis
Coagulopathy
ORAL
Company Report #
20 MG
18-Aug-2005
Page: 214
Manufacturer
Duration
Date:01/03/02ISR Number: 3847567-XReport Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Company Report #CTU 157928
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Headache
Dose
Report Source
Product
Role
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
20 MG/DAY,
ORAL
Marcumar
(Phenprocoumon)
Tablet
Edronax (Reboxetine)
Tablet
Doxycycline
(Doxycycline)
Omnic (Tamsulosin
Hydrochloride) Slow
Release Capsules
Date:01/03/02ISR Number: 3848715-8Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
1 1/ 2 Q 7AM;
PT
C
C
C
C
Company Report #CTU 158206
Report Source
Drug Ineffective
Product
Role
Ritalin 20mg Generic
PS
Manufacturer
Route
Manufacturer
Route
Pharmaceutical Product
1 1/ 2 Q
Complaint
10AM; 1/ 2 Q
2 PM; 1/ 2 PM
PRN
Date:01/04/02ISR Number: 3849615-XReport Type:Expedited (15-DaCompany Report #PHNU2001DE02785
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
PT
Duration
Report Source
Product
Role
Other
Bleeding Time Prolonged
Injury
Oedema Peripheral
Platelet Disorder
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
ORAL
Aspirin "Bayer"
(Acetylsaliculic
Acid)
SS
ORAL
ORAL
Platelet Function Test
Abnormal
ORAL
Date:01/04/02ISR Number: 3849617-3Report Type:Expedited (15-DaCompany Report #PHBS2001SE12774
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Pancytopenia
Foreign
Health
Professional
Other
Ritalina(Methylpheni
date Hydrochloride)
PS
Duration
Date:01/07/02ISR Number: 3852719-9Report Type:Expedited (15-DaCompany Report #2001-10-1935
Age:66 YR
Gender:Male
I/FU:F
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 215
11:49 AM
PT
Anorexia
Atelectasis
Demyelinating
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
SUBCUTANEOUS
Polyneuropathy
Difficulty In Walking
Drug Interaction
Dysphagia
Report Source
Product
Role
Faecal Incontinence
Guillain-Barre Syndrome
Haemoglobin Decreased
Study
Health
Professional
Intron A (Interferon
Alfa-2b Recombinant)
Injectable
PS
Joint Stiffness
Other
Metabolic Acidosis
Muscular Weakness
Ritalin Blinded
Study
SS
Nervous System Disorder
Platelet Count Decreased
Pneumonia
Po2 Decreased
Renal Cyst
Urinary Incontinence
Weight Decreased
Lipitor
(Atorvastatin)
Prilosec
Lasix
Glucophage
Micronase
K-Dur (Potassium
Chloride)
Inderal
Zyloprim
Multivitamins
Tylenol
Manufacturer
Route
Duration
10-6MU
SUBCUTANEOUS
ORAL
5MG BID ORAL
Date:01/08/02ISR Number: 3850075-3Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
C
C
C
C
C
C
C
C
C
C
Company Report #USP 54677
Report Source
Product
Role
Manufacturer
Metadate Er
(Methylphenidate
Hydrochloride)
PS
Medeva
Pharmaceuticals
Metadate Cd
(Methylphenidate
Hydrochloride)
SS
Celltech
Pharmaceuticals
Duration
Medication Error
Date:01/08/02ISR Number: 3850605-1Report Type:Direct
Age:4 YR
Gender:Female
I/FU:I
Company Report #CTU 158675
Route
Outcome
Dose
PT
Report Source
Product
Role
Ritalin
PS
Manufacturer
Route
Duration
Drug Ineffective
ORAL
20 MG BID PO
Pharmaceutical Product
Complaint
Date:01/09/02ISR Number: 3850212-0Report Type:Expedited (15-DaCompany Report #FLUV00301005243
Age:31 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Depressed Level Of
Consciousness
Dysarthria
Foreign
Literature
Health
Luvox 25
(Fluvoxamine
Maleate)
PS
ORAL
Pulmonary Infarction
Professional
Tryptanol
(Amitriptyline
Hydrochloride)
SS
ORAL
Wypax (Lorazepam)
SS
ORAL
75 MG DAILY
PO
Respiratory Disorder
Somnolence
Speech Disorder
75 MG DAILY;
PO
6 MG DAILY;
PO
Myonal (Eperisone
18-Aug-2005
Page: 216
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hydrochloride)
SS
ORAL
Perphenazine
(Perphenazine)
SS
ORAL
Lexotan (Bromazepam)
SS
ORAL
Halcion (Triazolam)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
Ravona
(Pentobarbital
Calcium)
SS
ORAL
Depas (Etizolam)
SS
ORAL
Brovarin
(Bromisoval)
SS
ORAL
300 MG DAILY;
PO
3 DF DAILY;
PO
15 MG DAILY;
PO
0.75 MG
DAILY; PO
20 MG DAILY;
PO
150 MG DAILY;
PO
6 MG DAILY;PO
0.5 G DAILY;
PO
Date:01/09/02ISR Number: 3850524-0Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
5MG Q AM,
NOON
PT
Company Report #CTU 158662
Report Source
Product
Role
Methylphenidate Hci
PS
Duration
Drug Ineffective
Manufacturer
Route
Methylphenidate Hci
SS
20MG Q AM,
NOON
Date:01/10/02ISR Number: 3851100-6Report Type:Direct
Age:37 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
PT
Company Report #CTU 158836
Report Source
Abnormal Behaviour
Anger
Product
Role
Methylphenidate
Tablets 20mg
PS
Zoloft
C
Manufacturer
Route
Manufacturer
Route
3 TABS, 5
Belligerence
TIMES/DAY
Chest Pain
(300 MG
Delusion
DAILY)/ 4 1/2
Myocardial Infarction
- 5 YRS OR
Date:01/10/02ISR Number: 3852294-9Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #CTU 158905
Report Source
Product
Role
Methylphenidate Generic
PS
Duration
Drug Ineffective
Pharmaceutical Product
Complaint
Date:01/11/02ISR Number: 3852041-0Report Type:Expedited (15-DaCompany Report #PHBS2002CH00502
Age:15 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 217
PT
Aggression
Agitation
Crying
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Depression
Disturbance In Attention
Drug Interaction
Dose
Report Source
Product
Role
Manufacturer
Route
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
ORAL
St. John'S Wort
(Hypericum
Perforatum)
SS
ORAL
Duration
20 MG/DAY,
Other
ORAL
5 GOUTES/DAY,
ORAL
Date:01/11/02ISR Number: 3852111-7Report Type:Direct
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 158975
Report Source
Product
Role
Abnormal Behaviour
Aggression
Methylphenidate
(Generic)
PS
Agitation
Clonidine
C
Manufacturer
Route
Duration
ORAL
20MG PO BID
Date:01/11/02ISR Number: 3852282-2Report Type:Direct
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
20 MG PO 2
PT
Company Report #CTU 158914
Report Source
Product
Role
Generic Ritalin
PS
Manufacturer
Route
Duration
Abnormal Behaviour
Agitation
TID
Drug Effect Decreased
Pharmaceutical Product
Complaint
Screaming
ORAL
Date:01/11/02ISR Number: 3852284-6Report Type:Direct
Age:16 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
2 AM AND 1
PT
Company Report #CTU 158916
Report Source
Product
Role
Ritalin (10mg)
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
Pharmaceutical Product
1/2 NOON
Complaint
EVERY DAY
Date:01/11/02ISR Number: 3852290-1Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 158898
Report Source
Product
Role
Methylphenidate
(Generic)
PS
Duration
Drug Effect Decreased
Pharmaceutical Product
RITALIN 5MG 2
Complaint
QAM 2 NOON 1
1/2 PM
Date:01/14/02ISR Number: 3852289-5Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Methylphenidate
PS
Duration
Drug Ineffective
20 MG AM AND
Pharmaceutical Product
NOON
Complaint
18-Aug-2005
Page: 218
Company Report #CTU 158897
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/14/02ISR Number: 3852748-5Report Type:Direct
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 159131
Report Source
Product
Role
Manufacturer
Route
Methylphenidate (20
Mg-Apothecon )
PS
Apothecon
ORAL
Product
Role
Manufacturer
Route
Methylphenidate
(Generic)
PS
Manufacturer
Route
Duration
Abnormal Behaviour
Agitation
20 MG PO TID
Drug Effect Decreased
Pharmaceutical Product
Complaint
Screaming
Date:01/14/02ISR Number: 3867402-3Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 161311
Report Source
Duration
Hallucination
5MG 1 BID
1
YR
Date:01/15/02ISR Number: 3852683-2Report Type:Direct
Age:57 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Disability
Other
20 MG PO TID
PT
Company Report #CTU 159129
Report Source
Disturbance In Attention
Drug Effect Decreased
Product
Role
Ritalin Sr Generic
20mg
PS
ORAL
Homeless
Pharmaceutical Product
Complaint
Relationship Breakdown
Date:01/15/02ISR Number: 3852755-2Report Type:Direct
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #CTU 159098
Report Source
Product
Role
Manufacturer
Route
Other
10MG 1 1/2
Drug Effect Decreased
Ritalin 10mg
PS
Pharmaceutical Product
TAB BID
Complaint
Date:01/15/02ISR Number: 3852759-XReport Type:Direct
Age:57 YR
Gender:Female
I/FU:I
Outcome
Dose
Disability
Other
20MG 1 PO
PT
Company Report #CTU 159126
Report Source
Product
Role
Manufacturer
Route
Ritalin Sr 20mg
Generic
PS
Generic
ORAL
Psychopharm
C
Manufacturer
Route
Duration
Disturbance In Attention
Drug Effect Decreased
Homeless
TID
Pharmaceutical Product
Complaint
Relationship Breakdown
Date:01/15/02ISR Number: 3853289-1Report Type:Expedited (15-DaCompany Report #PHEH2001US10491
Age:
Gender:Male
I/FU:I
Outcome
Dose
Death
18-Aug-2005
Page: 219
PT
Report Source
Product
Role
Death
Health
Professional
Ritalin(Methylphenid
ate Hydrochloride)
Tablet
PS
Duration
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/15/02ISR Number: 3853313-6Report Type:Direct
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 159204
Report Source
Product
Role
(Methylphenidate
Hcl) (20mg)
PS
Methylphenidate Hcl
10mg
SS
Manufacturer
Route
Manufacturer
Route
Duration
Aggression
Condition Aggravated
20MG Q AM,
Drug Ineffective
NOON
Impulsive Behaviour
Pharmaceutical Product
10MG Q Y PM
Complaint
Date:01/15/02ISR Number: 3853362-8Report Type:Direct
Age:14 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
36MG 1 DAY
PT
Company Report #CTU 159315
Report Source
Product
Role
Concerta Er 36mg
PS
Claritin
C
Duration
Abnormal Behaviour
ORAL
Aggression
ORAL
Alcoholism
Pyromania
Tobacco Abuse
Date:01/16/02ISR Number: 3854034-6Report Type:Expedited (15-DaCompany Report #PHBS2002GB00557
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abdominal Pain Upper
Aggression
Headache
Insomnia
Foreign
Literature
Health
Professional
Methylphenidate
(Methylphenidate
Hydrochloride)
Tablet
PS
Suicidal Ideation
Other
Manufacturer
Route
Duration
10 MG, TID,
ORAL
Vomiting
ORAL
Date:01/16/02ISR Number: 3854038-3Report Type:Expedited (15-DaCompany Report #PHNU2001DE02391
Age:63 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Disability
PT
Report Source
Product
Role
Agitation
Amnestic Disorder
C-Reactive Protein
Increased
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
10 MG/DAY,
Cerebral Artery Occlusion
ORAL
Cerebral Ischaemia
Confusional State
Disorientation
Electroencephalogram
Abnormal
Headache
Malaise
Memory Impairment
Monoparesis
Paresis
Pyrexia
Sensorimotor Disorder
Simple Partial Seizures
Speech Disorder
Vasculitis Cerebral
Vasospasm
Visual Disturbance
Visual Field Defect
18-Aug-2005
Page: 220
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/16/02ISR Number: 3854077-2Report Type:Expedited (15-DaCompany Report #PHBS2002GB00561
Age:20 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abdominal Pain Upper
Aggression
Drug Abuser
Nausea
Foreign
Literature
Health
Professional
Methylphenidate
(Methylphenidate
Hydrochloride)
Unknown
PS
Suicide Attempt
Other
Manufacturer
Route
Duration
ORAL
100 MG/DAY,
ORAL
Weight Decreased
Date:01/16/02ISR Number: 3854097-8Report Type:Expedited (15-DaCompany Report #PHBS2002GB00556
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abdominal Pain Upper
Aggression
Anorexia
Foreign
Literature
Health
Methylphenidate
(Methylphenidate
Hydrochloride)
PS
Chest Pain
Diarrhoea
Headache
Nightmare
Suicidal Ideation
Thirst
Vomiting
Professional
Other
Manufacturer
Route
Manufacturer
Route
Duration
75 MG/DAY
Date:01/16/02ISR Number: 3854099-1Report Type:Expedited (15-DaCompany Report #PHBS2002GB00559
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Aggression
Depression
Eyelid Function Disorder
Foreign
Literature
Health
Methylphenidate
(Methylphenidate
Hydrochloride)
PS
Headache
Professional
Insomnia
Other
Duration
10 MG, TID,
ORAL
ORAL
Suicidal Ideation
Tic
Weight Decreased
Date:01/17/02ISR Number: 3855648-XReport Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 159538
Report Source
Product
Role
Manufacturer
Methylphenidate
PS
Apothecon
Manufacturer
Route
Duration
Abnormal Behaviour
20MG AM,
Drug Ineffective
NOON, 4 PM
Pharmaceutical Product
Complaint
Date:01/17/02ISR Number: 3855905-7Report Type:Expedited (15-DaCompany Report #11973
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Idiopathic
Thrombocytopenic Purpura
Consumer
Concerta
(Methylphenidate
Hc1)
PS
Zyrtec
C
36MG 1X/1DAY,
ORAL
18-Aug-2005
Page: 221
11:49 AM
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/18/02ISR Number: 3856602-4Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
10MG 1 TAB
PT
Company Report #CTU 159618
Report Source
Product
Role
Methylphenidate 10mg
PS
Manufacturer
Route
Route
Duration
Abdominal Pain Upper
Decreased Appetite
T.I.D.
Fatigue
Nausea
Date:01/18/02ISR Number: 3856763-7Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 159685
Report Source
Product
Role
Manufacturer
Methylphenidate
10mg Watson
PS
Watson
Product
Role
Manufacturer
Methylphenidate 5 Mg
Screin
PS
Screin
Role
Manufacturer
Duration
Abdominal Pain Upper
Decreased Appetite
10MG 1T TAB
Fatigue
TID
Nausea
Date:01/22/02ISR Number: 3856949-1Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 159714
Report Source
Route
Duration
Anger
Drug Effect Decreased
5 MG TID
Pharmaceutical Product
Complaint
Date:01/22/02ISR Number: 3857625-1Report Type:Expedited (15-DaCompany Report #FLUV00301005243
Age:31 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization -
PT
Report Source
Product
Depressed Level Of
Foreign
Luvox 25
Route
Initial or Prolonged
Consciousness
Dysarthria
Literature
Health
Pulmonary Infarction
Professional
Refusal Of Treatment By
Relative
Somnolence
Other
(Fluvoxamine
Maleate)
PS
ORAL
Tryptanol
(Amitriptyline
Hydrochloride)
SS
ORAL
Wypax (Lorazepam)
SS
ORAL
Myonal (Eperisone
Hydrochloride)
SS
ORAL
Perphenazine
(Perphenazine)
SS
ORAL
Lexotan (Bromazepam)
SS
ORAL
Halcion (Triazolam)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
Ravona
(Pentobarbital
Calcium)
SS
ORAL
75 MG DAILY;
PO
75 MG DAILY;
Ventilation/Perfusion
PO
Scan Abnormal
6 MG DAILY;
PO
300 MG DAILY;
PO
3 DF DAILY;
PO
15 MG DAILY;
PO
0.75 MG
DAILY; PO
20 MG DAILY;
PO
150 MG DAILY;
PO
18-Aug-2005
Page: 222
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Depas (Etizolam)
SS
ORAL
Brovarin
(Bromisoval)
SS
ORAL
6 MG DAILY;
PO
0.5 G DAILY;
PO
Date:01/23/02ISR Number: 3856927-2Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #CTU 159736
Report Source
Product
Role
Methylphenidate
PS
Manufacturer
Route
Manufacturer
Route
Duration
Abnormal Behaviour
Drug Effect Decreased
Pharmaceutical Product
Complaint
Date:01/23/02ISR Number: 3857933-4Report Type:Expedited (15-DaCompany Report #PHBS2001JP06554
Age:16 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Cataplexy
Hallucination
Hallucinations, Mixed
Foreign
Literature
Health
Ritaline
(Methylphenidate
Hydrochloride)
PS
ORAL
Professional
Other
Anafranil
(Clomipramine
Hydrochloride)
SS
ORAL
Pemoline (Pemoline)
SS
ORAL
ORAL
Date:01/23/02ISR Number: 3858190-5Report Type:Direct
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #CTU 159758
Report Source
Product
Role
Manufacturer
Route
Other
5MG IN AM 15
Drug Ineffective
Methylphenidate
PS
MG @ NOON
Date:01/23/02ISR Number: 3859599-6Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #CTU 159974
Report Source
Product
Role
Methylphenidate
PS
Manufacturer
Route
Manufacturer
Route
Duration
Abnormal Behaviour
Date:01/23/02ISR Number: 3859792-2Report Type:Periodic
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Company Report #NSADSS2001002131
PT
Report Source
Product
Role
Suicide Attempt
Weight Increased
Consumer
Risperdal
(Unspecified)
(Risperidone)
PS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
0.5 MG, 3 IN
1 DAY(S),
ORAL
ORAL
Ddavp (Desmopressin)
Zoloft (Sertraline
Hydrochloride)
Buspar (Buspirone
18-Aug-2005
Page: 223
11:49 AM
C
C
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hydrochloride)
C
Date:01/24/02ISR Number: 3860016-0Report Type:Expedited (15-DaCompany Report #PHBS2002BR01038
Age:28 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Anorexia
Anxiety
Crying
Depressed Mood
Foreign
Consumer
Other
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
10 MG, BID,
Dry Mouth
ORAL
Dysphemia
Hyperhidrosis
Mood Swings
Nervousness
Tachycardia
Tremor
Date:01/24/02ISR Number: 3860033-0Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
20MG TID/PO
PT
Flurazepam
(Flurazepam) Tablet
Tryptanol
(Amitriptline
Hydrochloride)
Tablet
C
C
Company Report #CTU 159933
Report Source
Product
Role
Methylphenidate 20mg
PS
Manufacturer
Route
Duration
Dyspepsia
ORAL
Pharmaceutical Product
Complaint
Date:01/24/02ISR Number: 3860037-8Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 159937
Report Source
Product
Role
Manufacturer
Ritalin (Daw)
PS
Daw
Duration
Abnormal Behaviour
10MG 2 1/2
Drug Effect Decreased
TAB TID
Pharmaceutical Product
Complaint
Route
Psychomotor Hyperactivity
Date:01/24/02ISR Number: 3860100-1Report Type:Direct
Age:39 YR
Gender:Female
I/FU:I
Outcome
Dose
Disability
PT
Company Report #CTU 159932
Report Source
Product
Role
Drug Ineffective
Pharmaceutical Product
Methylphenidate
(20mg 1 Tid)
PS
Complaint
Lorazepam
Tylenol #4
Protriptyline
C
C
C
Manufacturer
Route
Duration
ORAL
20 MG PO TID
Date:01/25/02ISR Number: 3860247-XReport Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 224
PT
Company Report #USP 54716
Report Source
Product
Role
Manufacturer
Metadate Cd
Metadate Er
PS
SS
Medeva
Medeva
Duration
Medication Error
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/25/02ISR Number: 3860610-7Report Type:Expedited (15-DaCompany Report #MPI-2002-00008 (0)
Age:4 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abnormal Behaviour
Aggression
Medication Error
Screaming
Health
Professional
Company
Representative
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride
Extended-Release
PS
Manufacturer
Route
ORAL
40 MG QD PO
Date:01/28/02ISR Number: 3862130-2Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Methylphenidate
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
Appetite Disorder
Drug Effect Decreased
Pharmaceutical Product
Complaint
Date:01/29/02ISR Number: 3860905-7Report Type:Direct
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
20MG SR
Company Report #CTU 160276
PT
Company Report #CTU 160382
Report Source
Product
Role
Ritalin - Generic
PS
Duration
Drug Effect Decreased
IN
Educational Problem
AM & 10 MG
Pharmaceutical Product
-BETWEEN 2-3
Complaint
PM
Date:01/29/02ISR Number: 3862102-8Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #CTU 160360
Report Source
Product
Role
Drug Effect Decreased
20 MG AM
Ritalin [Generic]
PS
ORAL
AND
Pharmaceutical Product
PM PO
Complaint
Date:01/30/02ISR Number: 3861745-5Report Type:Direct
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
5 MG
PT
Company Report #CTU 160380
Report Source
Product
Role
Manufacturer
PS
Medeva
Product
Role
Manufacturer
Ritalin
PS
Generic Ritalin
C
Route
Duration
Abnormal Behaviour
Drug Effect Decreased
Methylphenidate
Mg) - (Medeva)
(5
3-TABS
Pharmaceutical Product
BID
Complaint
Psychomotor Hyperactivity
Date:01/30/02ISR Number: 3862336-2Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
AM &
Pharmaceutical Product
PM
PO
Complaint
18-Aug-2005
Page: 225
Route
Duration
Drug Effect Decreased
20 MG
Company Report #CTU 160448
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/30/02ISR Number: 3862360-XReport Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Disability
ONE IN AM
Other
ONE TID
PT
Company Report #CTU 160459
Report Source
Product
Role
Drug Effect Decreased
Methylphenidate
PS
Pharmaceutical Product
Methylphenidate
SS
Complaint
Tenex
C
Manufacturer
Route
Manufacturer
Route
Duration
Date:01/30/02ISR Number: 3862504-XReport Type:Expedited (15-DaCompany Report #PHBS2001JP06554
Age:16 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Hallucination
Foreign
Literature
Health
Professional
Ritaline
(Methlpenidate
Hydrochloride)
Unknown
PS
ORAL
Anafranil
(Clomipramine
Hydrochloride)
Unknown
SS
ORAL
Pemoline (Pemoline)
SS
ORAL
ORAL
Date:01/30/02ISR Number: 3863606-4Report Type:Periodic
Age:41 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Company Report #PHEH2000US11744
PT
Report Source
Product
Role
Manufacturer
Abnormal Behaviour
Anorexia
Dry Skin
Insomnia
Consumer
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
ORAL
Prozac (Fluoxetine
Hydrochloride)
SS
ORAL
Route
3 TABS DAILY,
Skin Discolouration
ORAL
Weight Decreased
ORAL
Zantac
Prilosec
(Omeprazole)
Date:01/30/02ISR Number: 3863609-XReport Type:Periodic
Age:73 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
C
C
Company Report #PHEH2001US01007
PT
Report Source
Product
Role
Manufacturer
Route
Convulsion
Fall
Loss Of Consciousness
Health
Professional
Ritalin(Methylphenid
ate Hydrochloride)
Tablet, 10mg
PS
ORAL
Wellbutrin-Slow
Release
(Amfebutamone
Hydrochloride) 150mg
SS
ORAL
Duration
5 0MG QD,
ORAL
2190 DAY
150 MG, BID,
ORAL
30
DAY
Date:01/30/02ISR Number: 3863612-XReport Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 226
PT
Aggression
Depression
Panic Attack
11:49 AM
Company Report #PHEH2001US01545
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Somnolence
Dose
Report Source
Product
Role
Consumer
Ritalin(Methylphenid
ate Hydrochloride)
Tablet
PS
Accutane(Isotretinoi
n)
SS
Manufacturer
Route
Duration
ORAL
ORAL
ORAL
Date:01/30/02ISR Number: 3863615-5Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #PHEH2001US03183
PT
Report Source
Product
Role
Petit Mal Epilepsy
Staring
Health
Professional
Ritalin(Methylphenid
ate Hydrochloride)
Tablet
PS
Multivitamins
(Panthenol, Retinol,
Ascorbic Acid)
C
Manufacturer
Route
Duration
ORAL
15-25 MG QD,
ORAL
Date:01/30/02ISR Number: 3863617-9Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #PHEH2001US03784
PT
Report Source
Product
Role
Tourette'S Disorder
Consumer
Ritalin(Methylphenid
ate Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
22.5 MG
DAILY, ORAL
Date:01/30/02ISR Number: 3863620-9Report Type:Periodic
Age:86 YR
Gender:Female
I/FU:I
Company Report #PHEH2001US04868
ORAL
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Delirium
Health
Professional
Ritalin(Methylphenid
ate Hydrochloride)
Tablet
PS
ORAL
Fluvoxamine(Fluvoxam
ine)
SS
ORAL
Loramet(Lormetazepam
)
SS
Duration
40 MG, QD,
ORAL
75 MG, QD,
ORAL
2 MG, QD
Date:01/30/02ISR Number: 3863622-2Report Type:Periodic
Age:47 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Company Report #PHEH2001US08877
PT
Report Source
Product
Role
Manufacturer
Route
Accidental Overdose
Faecal Incontinence
Grand Mal Convulsion
Health
Professional
Ritalin(Methylphenid
ate Hydrochloride)
Tablet, 20mg
PS
ORAL
Gabitril(Tiagabine
Hydrochloride)
SS
ORAL
20 MG, QID,
Mental Status Changes
ORAL
Urinary Incontinence
2 MG, QD,
ORAL; 16 MG,
QD, ORAL; 32
MG, QD
18-Aug-2005
Page: 227
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Seroquel(Quetiapine)
SS
ORAL
Paxil (Paroxetine
Hydrochloride)
SS
ORAL
50 MG, BID,
ORAL; 500 MG,
QHS, ORAL
30 MG, QD,
ORAL
Lamictal
Biaxin
(Clarithromycin)
Neurontin
(Gabapentin)
Imitrex "Glaxo"
(Sumatriptan)
Ranitidine
(Mirtazapine)
Synthroid
Date:01/31/02ISR Number: 3862355-6Report Type:Direct
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
C
C
C
C
C
C
Company Report #CTU 160458
Report Source
Product
Role
Drug Ineffective
Impulsive Behaviour
Ritalin - Sr 20mg
Generic Brand
PS
Pharmaceutical Product
Ritalin Tab 10 + 5mg
SS
Manufacturer
Route
Duration
ORAL
1 PO Q AM
15 MG Q 7AM &
Complaint
11AM
Psychomotor Hyperactivity
Date:01/31/02ISR Number: 3862729-3Report Type:Direct
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 160532
Report Source
Product
Duration
Rash
Methylphenidate(-Med
Role
Manufacturer
Route
eva)
PS
5MG QD
Date:02/01/02ISR Number: 3863268-6Report Type:Direct
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 160576
Report Source
Product
Role
Manufacturer
Route
Duration
Abnormal Behaviour
Aggression
Methylphenidate
Mg
20
PS
ORAL
20 MG TID PO
Disturbance In Attention
Pharmaceutical Product
Complaint
Date:02/01/02ISR Number: 3863271-6Report Type:Direct
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
7.5 MG TID
PT
Report Source
Product
Role
Ritalin Generic
PS
Duration
Drug Effect Decreased
Pharmaceutical Product
Complaint
18-Aug-2005
Page: 228
Company Report #CTU 160578
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/04/02ISR Number: 3863871-3Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 160684
Report Source
Product
Role
Manufacturer
Route
Methylphenidate
10mg Watson
PS
Watson
Product
Role
Manufacturer
Ritalin (Brand Name)
Manufacturer Schein
5mg Tid
PS
Schein
Product
Role
Manufacturer
Route
Methylphenidate
PS
Alprazolam
Darvocet
Hctz
Hydroxyzine
Protriptyline
Nexium
C
C
C
C
C
C
Manufacturer
Route
Duration
Drug Ineffective
10 MG TAB TID
Date:02/04/02ISR Number: 3863885-3Report Type:Direct
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 160688
Report Source
Route
Duration
Drug Effect Decreased
ADHD
Date:02/04/02ISR Number: 3863887-7Report Type:Direct
Age:40 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #CTU 160690
Report Source
Duration
Drug Ineffective
20 MG TID
Date:02/04/02ISR Number: 3865366-XReport Type:Expedited (15-DaCompany Report #PHBS2002DK01472
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Colitis Ulcerative
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
PS
Duration
Other
Date:02/05/02ISR Number: 3865327-0Report Type:Direct
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 160859
Report Source
Product
Role
Manufacturer
Methylphenidate 5mg
Medeva
PS
Medeva
Duration
Abnormal Behaviour
Attention
5MG 3 TABS
Deficit/Hyperactivity
BID
Disorder
Drug Effect Decreased
Pharmaceutical Product
Complaint
Date:02/05/02ISR Number: 3865806-6Report Type:Expedited (15-DaCompany Report #MPU-2002-00041(0)
Age:
Gender:Female
I/FU:I
Outcome
Other
18-Aug-2005
Page: 229
PT
Abdominal Pain Upper
Aggression
Headache
Insomnia
Suicidal Ideation
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Vomiting
Dose
Report Source
Product
Role
Foreign
Health
Professional
Other
Methylphenidate
Tablets
(Unspecified)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
10MG THREE
TIMES DAILY
Date:02/05/02ISR Number: 3865809-1Report Type:Expedited (15-DaCompany Report #MPU-2002-00040(0)
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
10MG THREE
PT
Report Source
Product
Role
Aggression
Foreign
Methylphenidate
PS
Depression
Health
Headache
Insomnia
Self-Injurious Ideation
Suicidal Ideation
Tic
Weight Decreased
Professional
Other
Duration
TIMES DAILY
Date:02/05/02ISR Number: 3865816-9Report Type:Expedited (15-DaCompany Report #MPU-2002-00039(0)
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
75MG DAILY
PT
Report Source
Product
Role
Abdominal Pain Upper
Foreign
Methylphenidate
PS
Aggression
Chest Pain
Decreased Appetite
Diarrhoea
Headache
Medication Error
Nightmare
Health
Professional
Other
Duration
Self Injurious Behaviour
Suicidal Ideation
Thirst
Vomiting
Date:02/05/02ISR Number: 3865820-0Report Type:Expedited (15-DaCompany Report #MPU-2002-00032(0)
Age:20 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abdominal Pain Upper
Aggression
Nausea
Foreign
Health
Professional
Methylphenidate
Methylphenidate
Hydrochloride)
PS
Suicide Attempt
Weight Decreased
Other
Manufacturer
Route
Manufacturer
Route
Duration
100 MG/DAY
Date:02/05/02ISR Number: 3865977-1Report Type:Expedited (15-DaCompany Report #MK200201-0326-1
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 230
11:49 AM
PT
Report Source
Product
Role
Hallucination
Hallucination, Tactile
Hallucinations, Mixed
Foreign
Literature
Anafranil 25mg
Capsules 100
Ritalin
PS
SS
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pemoline
SS
Date:02/05/02ISR Number: 3866813-XReport Type:Expedited (15-DaCompany Report #MPI-2002-00044 (0)
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
INTRAVENOUS
PT
Report Source
Product
Role
Medication Error
Health
Professional
Company
Representative
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride
Extended-Release
PS
Manufacturer
Route
Manufacturer
Route
IV
Date:02/05/02ISR Number: 3866902-XReport Type:Expedited (15-DaCompany Report #MPI-2002-00008(1)
Age:4 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abnormal Behaviour
Aggression
Medication Error
Physical Assault
Screaming
Health
Professional
Company
Representative
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride
Extended-Release
PS
ORAL
40MG QD PO
Date:02/06/02ISR Number: 3865148-9Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Pharmaceutical Product
Complaint
Social Avoidant Behaviour
Tic
MG AT 3 PM
Report Source
Product
Role
Methylphenidate
20mg Am, 15mg At
Noon & 75 Mg At 3 Pm
PS
Duration
20MG AM, 15MG
AT NOON & 75
Company Report #CTU 160957
Manufacturer
Route
Date:02/06/02ISR Number: 3866329-0Report Type:Expedited (15-DaCompany Report #PHBS2002DK01505
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Eye Pain
Glaucoma
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Unknown
PS
Manufacturer
Route
Duration
ORAL
40 MG/DAY,
Other
ORAL
Date:02/06/02ISR Number: 3866477-5Report Type:Expedited (15-DaCompany Report #PHNU2001DE02641
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
10 MG, BID,
ORAL
18-Aug-2005
Page: 231
PT
Report Source
Product
Role
Asthenia
Difficulty In Walking
Paraesthesia
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/07/02ISR Number: 3866152-7Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 161215
Report Source
Product
Role
Manufacturer
Route
Route
Duration
Crying
Emotional Disorder
Headache
Ritalin 10mg
12 Pm, 4 Pm
Generic
1 8am,
PS
10MG, 8 AM,
Pharmaceutical Product
12 PM, 4 PM
Complaint
Date:02/07/02ISR Number: 3866154-0Report Type:Direct
Age:13.5 YR Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
25 MG AM,
PT
Trazadone
C
Company Report #CTU 161217
Report Source
Abnormal Behaviour
Condition Aggravated
Product
Role
Manufacturer
Ritalin 20mg &
Generic Ritalin 5mg
PS
Novartis
Product
Role
Manufacturer
Route
Ritalin
PS
Manufacturer
Route
Homicidal Ideation
25MG NOON
Impulsive Behaviour
10MG @ 1600
Date:02/07/02ISR Number: 3866315-0Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Duration
Drug Ineffective
Pharmaceutical Product
Complaint
Date:02/07/02ISR Number: 3866319-8Report Type:Direct
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #CTU 161153
PT
Company Report #CTU 161164
Report Source
Product
Duration
Abnormal Behaviour
Methylfenidate
Role
Agitation
(Mallinckrodt)
PS
Mallinckrodt
Product
Role
Manufacturer
Route
Methylphenidate 5mg
Medeva
PS
Medeva
ORAL
Product
Role
Manufacturer
Route
Ritalin 10mg
PS
5 MG 1/2 TAB
AM NOON, 4 PM
Date:02/07/02ISR Number: 3866321-6Report Type:Direct
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
5MG
PT
Company Report #CTU 161165
Report Source
Duration
Attention
Deficit/Hyperactivity
3 TABS
Disorder
BID
Pharmaceutical Product
Complaint
Speech Disorder
Date:02/07/02ISR Number: 3866324-1Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Duration
Drug Effect Decreased
1 1/2 TID PO
Pharmaceutical Product
Complaint
18-Aug-2005
Page: 232
Company Report #CTU 161169
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/07/02ISR Number: 3867761-1Report Type:Expedited (15-DaCompany Report #2002-01-2338
Age:31 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
3 DF QD ORAL
Other
75 MG QD ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Depressed Level Of
Consciousness
Foreign
Literature
Trilafon
(Perphenazine)
PS
ORAL
Dysarthria
Health
Luvox
SS
ORAL
Electrocardiogram
Professional
Tryptanol
SS
ORAL
Abnormal
Other
Wypax
SS
ORAL
Myonal
SS
ORAL
Lexotan
SS
ORAL
Halcion
SS
ORAL
Ritalin
SS
ORAL
Ravona
SS
ORAL
Depas
SS
ORAL
Brovarin
SS
ORAL
75 MG QD ORAL
6 MG QD ORAL
Pulmonary Infarction
300
MG QD
Respiratory Disorder
ORAL
Somnolence
15 MG QD ORAL
0.75 MG QD
ORAL
20 MG QD ORAL
150 MG QD
ORAL
6 MG QD ORAL
0.5 G QD ORAL
Date:02/08/02ISR Number: 3866155-2Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 161218
Report Source
Product
Role
Ritalin
PS
Duration
Drug Ineffective
Manufacturer
Route
Date:02/08/02ISR Number: 3866982-1Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 161310
Report Source
Product
Role
Manufacturer
Route
Methylphenidate Made
By Geneva
PS
Geneva
ORAL
Manufacturer
Route
Duration
Drug Effect Decreased
Pharmaceutical Product
1 1/2 TID PO
Complaint
Date:02/08/02ISR Number: 3867360-1Report Type:Expedited (15-DaCompany Report #2002091771JP
Age:31 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
ORAL
PT
Report Source
Product
Role
Depressed Level Of
Consciousness
Foreign
Literature
Halcion (Triazolam)
Tablet
PS
ORAL
Drug Interaction
Gamma-Glutamyltransferase
Other
Luvox (Fluvoxamine
Maleate)
SS
ORAL
Increased
Hypothermia
Pulmonary Infarction
Tryptanol
(Amitriptyline
Hydrochloride)
SS
ORAL
Respiratory Disorder
Wypax (Lorazepam)
SS
ORAL
Somnolence
Speech Disorder
Myonal (Eperisone
Hydrochloride)
SS
ORAL
Stupor
Tachycardia
Perphenazine
(Perphenazine)
SS
ORAL
Lexotan (Bromazepam)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
Ravona
(Pentobarbital
Calcium)
SS
ORAL
Depas (Etizolam)
C
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
18-Aug-2005
Page: 233
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/08/02ISR Number: 3868544-9Report Type:Expedited (15-DaCompany Report #11973
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Idiopathic
Thrombocytopenic Purpura
Consumer
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Zyrtec
C
Manufacturer
Route
ORAL
36MG 1X/1DAY,
ORAL
Date:02/11/02ISR Number: 3868515-2Report Type:Expedited (15-DaCompany Report #PHBS2002JP01199
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
SEE IMAGE
PT
Report Source
Product
Role
Manufacturer
Route
Anaemia
Aplasia Pure Red Cell
Foreign
Health
Tegretol(Carbamazepi
ne)
PS
ORAL
Dizziness
Dyspnoea Exertional
Nausea
Pallor
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Unknown
SS
ORAL
5 MG/DAY,
Vomiting
ORAL
Date:02/12/02ISR Number: 3868427-4Report Type:Direct
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
10MG TID
PT
Company Report #CTU 161455
Report Source
Product
Role
Ritalin(Generic)
Methylphenidate
PS
Duration
Condition Aggravated
Diarrhoea
1
MON
Disturbance In Attention
Drug Ineffective
Dyspepsia
Headache
Insomnia
Irritability
Manufacturer
Route
Pharmaceutical Product
Complaint
Restlessness
Date:02/13/02ISR Number: 3870462-7Report Type:Expedited (15-DaCompany Report #PHBS2002JP01502
Age:32 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Drug Interaction
Dysarthria
Electrocardiogram
Foreign
Literature
Health
Ritaline
(Methylphenidate
Hydrochloride)
PS
ORAL
Abnormal
Professional
Gamma-Glutamyltransferase
Increased
Other
Luvox (Fluvoxamine
Maleate)
SS
ORAL
Tryptanol
(Amitriptyline
Hydrochloride)
SS
ORAL
Somnolence
Wypax (Lorazepam)
SS
ORAL
Speech Disorder
Stupor
Myonal (Eperisone
Hydrochloride)
SS
ORAL
Perphenazine
(Perphenazine)
SS
ORAL
20 MG/DAY
ORAL
75 MG/DAY
Hypothermia
ORAL
Pulmonary Infarction
Refusal Of Treatment By
Patient
75 MG/DAY
Respiratory Disorder
ORAL
6 MG/DAY ORAL
300MG/DAY
Tachycardia
ORAL
Ventilation/Perfusion
Scan Abnormal
3 DF/DAY ORAL
18-Aug-2005
Page: 234
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Lexotan (Bromazepam)
SS
ORAL
Ravona
(Pentobarbital
Calcium)
SS
ORAL
Depas (Etizolam)
SS
ORAL
Halcion (Triazolam)
SS
ORAL
Brovarin
(Bromisoval)
SS
ORAL
15 MG/DAY
ORAL
150 MG/DAY,
ORAL
6 MG/DAY ORAL
0.75 MG /DAY
ORAL
0.5 G/DAY
ORAL
Date:02/13/02ISR Number: 3877738-8Report Type:Periodic
Age:45 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Intentional Misuse
Health
Professional
Other
Oxycodone
Hydrochloride
Bupropion
Meperidine
Acetaminophen
Ketamine
Hydrochloride
Ritalin
(Methylphenidate)
Role
Manufacturer
Route
Manufacturer
Route
Duration
Date:02/15/02ISR Number: 3870865-0Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Company Report #2013023
PT
Duration
PS
SS
SS
SS
SS
SS
Company Report #CTU 161733
Report Source
Product
Role
Appetite Disorder
Ritalin
PS
10 MG QAM & Q
Attention
NOON
Deficit/Hyperactivity
Disorder
Drug Effect Decreased
Pharmaceutical Product
Complaint
Date:02/19/02ISR Number: 3870763-2Report Type:Direct
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
5MG 1 IN AM
PT
Company Report #CTU 161769
Report Source
Product
Role
Methylphenidate
PS
Manufacturer
Route
Route
Duration
Drug Ineffective
15 MG @ NOON
Date:02/19/02ISR Number: 3871241-7Report Type:Direct
Age:6 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Manufacturer
Ritalin (Generic)
Methylphenidate By
Watson
PS
Watson
Duration
Nausea
Pharmaceutical Product
Complaint
10MG PO Q AM,
Q NOON, 5MG Q
3:30
18-Aug-2005
Page: 235
Company Report #CTU 161842
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/19/02ISR Number: 3871972-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB00758
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Systemic Lupus
Erythematosus
Foreign
Health
Professional
Other
Ritaline(Methylpheni
date Hydrochloride)
PS
Date:02/20/02ISR Number: 3872639-3Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
Manufacturer
Route
Manufacturer
Route
Duration
PT
Company Report #CTU 161943
Report Source
Product
Role
Methylphenidate(Gene
ric)
PS
Duration
Drug Effect Decreased
Pharmaceutical Product
ORAL
5MG, PO CP UP
Complaint
TO TID
Date:02/21/02ISR Number: 3872778-7Report Type:Direct
Age:16 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 162062
Report Source
Product
Role
Manufacturer
Ritalin 10mg Generic
Medeva Rochester Ny
PS
Medeva
Role
Manufacturer
Route
Duration
Drug Effect Decreased
Pharmaceutical Product
2 AM + 1 1/2
Complaint
NOON EVERY
DAY
Date:02/21/02ISR Number: 3906552-XReport Type:Periodic
Age:52 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
Company Report #300991
PT
Report Source
Product
Diarrhoea
Consumer
Xenical (Orlistat)
Duration
Route
Haematochezia
120 Mg
PS
ORAL
120 MG 2 PER
Rectal Discharge
DAY ORAL
Herbal Medicine
(Herbal Extract Nos)
Ritalin
(Methylphenidate
Hydrochloride)
Effexor (Vanlafaxine
Hydrochloride)
SS
SS
C
Date:02/22/02ISR Number: 3875210-2Report Type:Expedited (15-DaCompany Report #PHBS2002JP01199
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
SEE IMAGE
PT
Report Source
Product
Role
Anaemia
Aplasia Pure Red Cell
Foreign
Health
Tegretol
(Carbamazepine)
PS
ORAL
Dizziness
Dyspnoea Exertional
Nausea
Pallor
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
SS
ORAL
5 MG/DAY,
Vomiting
ORAL
18-Aug-2005
Page: 236
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/25/02ISR Number: 3874259-3Report Type:Expedited (15-DaCompany Report #2002UW02017
Age:31 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 75 MG DAILY
Initial or Prolonged
PO
PT
Report Source
Product
Role
Manufacturer
Route
Blood Pressure Increased
Foreign
Elavil
PS
ORAL
Body Temperature
Literature
Decreased
Health
Luvox
SS
ORAL
Depressed Level Of
Professional
Wypax
SS
ORAL
Consciousness
Other
Myonal
SS
ORAL
Electrocardiogram
Perphenazine
SS
ORAL
Abnormal
Lexotan
SS
ORAL
Lung Disorder
Halcion
SS
ORAL
Po2 Decreased
Ritalin
SS
ORAL
Pulmonary Infarction
Ravona
SS
ORAL
Respiratory Disorder
Depas
SS
ORAL
Scintigraphy
Brovarin
SS
ORAL
75 MG QD PO
6 MG QD PO
300 MG DAILY
Dysarthria
PO
3 DF QD PO
15 MG DAILY
Hypothermia
PO
0.75 MG QD PO
20 MG QD PO
150 MG QD PO
6 MG QD PO
0.5 G DAILY
Somnolence
PO
Tachycardia
Ventilation/Perfusion
Scan Abnormal
Date:02/25/02ISR Number: 3875151-0Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #CTU 162272
Report Source
Product
Role
Manufacturer
Route
Attention
Methylphenidate
10MG PO TID
Deficit/Hyperactivity
PRIOR TO
Disorder
11/18/1998
Pharmaceutical Product
Complaint
Date:02/25/02ISR Number: 3875165-0Report Type:Direct
Age:7 YR
Gender:Male
I/FU:I
Outcome
Life-Threatening
Hospitalization Initial or Prolonged
Disability
Required
Intervention to
Prevent Permanent
Impairment/Damage
18-Aug-2005
Page: 237
11:49 AM
PT
Abdominal Pain
Adjustment Disorder
Aggression
Agitation
Anxiety
Catatonia
Chest Pain
Constipation
Decreased Appetite
Depression
Dry Mouth
Headache
Keratoconjunctivitis
Sicca
Mood Altered
Obsessive-Compulsive
Disorder
Palpitations
Personality Disorder Of
Childhood
Post-Traumatic Stress
Disorder
Psychomotor Hyperactivity
Company Report #CTU 162289
PS
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Psychomotor Skills
Impaired
Psychotic Disorder
Dose
Report Source
Product
Role
Manufacturer
Route
Route
Duration
Pyrexia
Sleep Disorder
Suicidal Ideation
Vision Blurred
Vomiting
Ritalin
10mg
Clondine
.5mg Then
PS
SS
Date:02/26/02ISR Number: 3873642-XReport Type:Expedited (15-DaCompany Report #306100
Age:31 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization 1
DAY
Initial or Prolonged
2
PT
Report Source
Product
Role
Manufacturer
Drug Interaction
Health
Cercine
PS
Roche
Gamma-Glutamyltransferase
Increased
Hypothermia
Pulmonary Infarction
Stupor
Tachycardia
Professional
Lexotan
Luvox
Tryptanol
Wypax
Myonal
Perphenazine
Halcion
Ritalin
Ravona
Depas
Brovarin
Vegetamin A
Kefral
Cefzon
Voltaren
Erispan
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
Roche
DAY
Date:02/26/02ISR Number: 3873643-1Report Type:Expedited (15-DaCompany Report #306100
Age:31 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization 1
DAY
Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Drug Interaction
Health
Cercine
PS
Roche
Gamma-Glutamyltransferase
Professional
Lexotan
I
Roche
Route
Increased
Hypothermia
Pulmonary Infarction
Stupor
Tachycardia
2
DAY
18-Aug-2005
Page: 238
11:49 AM
Luvox
Tryptanol
Wypax
Myonal
Perphenazine
Halcion
Ritalin
Ravona
Depas
Brovarin
Vegetamin A
Kefral
Cefzon
Voltaren
Erispan
I
I
I
I
I
I
I
I
I
I
I
I
I
I
I
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/26/02ISR Number: 3874972-8Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 162337
Report Source
Product
Role
Manufacturer
Route
Methylphenidate 10mg
PS
Geneva
ORAL
Product
Role
Manufacturer
Route
Luvox 25
(Fluvoxamine
Maleate)
PS
ORAL
Abnormal
Overdose
Pulmonary Infarction
Tryptanol
(Amitriptyline
Hydrochloride)
SS
ORAL
Respiratory Disorder
Wypax (Lorazepam)
SS
ORAL
Somnolence
Speech Disorder
Myonal (Eperisone
Hydrochloride)
SS
ORAL
Perphenazine
(Perphenazine)
SS
ORAL
Lexotan (Bromazepam)
SS
ORAL
Halcion (Triazolam)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
Duration
Drug Effect Decreased
10 MG PO QID
Pharmaceutical Product
Complaint
Date:02/27/02ISR Number: 3876472-8Report Type:Expedited (15-DaCompany Report #FLUV00301005243
Age:31 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Abnormal Behaviour
Depressed Level Of
Consciousness
Report Source
75 MG DAILY
Electrocardiogram
PO
75 MG DAIL PO
6 MG DAILY PO
300 MG DAILY
PO
3 DF DAILY PO
15 DAILY PO
0.75 MG DAILY
PO
20 MG DAILY
PO
Ravona
(Pentobarbital
Calcium)
SS
ORAL
Depas (Etizolam)
SS
ORAL
Brovarin
(Bromisoval)
SS
ORAL
150 MG DAILY
PO
6 MG DAILY PO
0.5 G DAILY
PO
Date:02/28/02ISR Number: 3878392-1Report Type:Expedited (15-DaCompany Report #306100
Age:31 YR
Gender:Male
I/FU:F
Outcome
PT
Dose
Duration
Hospitalization Depressed Level Of
INTRAMUSCULAR
INTRAMUSCULAR
Initial or Prolonged
Consciousness
Dilatation Atrial
15 MG DAILY
Drug Interaction
ORAL
Dysarthria
Dyspnoea
75 MG DAILY
Gamma-Glutamyltransferase
ORAL
Increased
Hypothermia
Pulmonary Infarction
Somnolence
75 MG DAILY
Speech Disorder
ORAL
Stupor
Tachycardia
6 MG DAILY
Tremor
ORAL
18-Aug-2005
Page: 239
11:49 AM
Report Source
Product
Role
Manufacturer
Route
Foreign
Cercine (Diazepam)
PS
Literature
Health
Lexotan (Bromazepam)
50 Unit
SS
ORAL
Luvox (Fluvoxamine)
25 Unit
SS
ORAL
Tryptanol
(Amitriptyline
Hydrochloride) 25
Unit
SS
ORAL
Wypax (Lorazepam) 1
Unit
SS
ORAL
Professional
Other
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Myonal (Eperisone) 5
Unit
SS
ORAL
Perphenazine
(Perphenazine) 4
Unit
SS
ORAL
Halcion (Triazolam)
0.25 Unit
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
Ravona
(Pentobarbital
SS
ORAL
Depas (Etizolam)
SS
ORAL
Brovarin
(Bromisovalum)
SS
ORAL
Vegetamin A
(Chlorpromazine
Hydrochloride/Phenob
arbital/Promethazine
Hydrochloride)
SS
ORAL
Kefral (Cefaclor)
250 Unit
SS
ORAL
Cefzon (Cefdinir)
SS
ORAL
300 MG DAILY
ORAL
3 DOSE FORM
DAILY ORAL
0.75 MG DAILY
ORAL
20 MG DAILY
ORAL
150 MG DAILY
ORAL
6 MG DAILY
ORAL
0.5 GRAM
DAILY ORAL
ORAL
ORAL
ORAL
Voltaren (Diclofenac
Sodium)
SS
ORAL
Erispan
(Fludiazepam)
SS
ORAL
ORAL
ORAL
Date:02/28/02ISR Number: 3886280-XReport Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Company Report #12137
PT
Report Source
Product
Role
Agitation
Hallucination
Headache
Consumer
Concerta
(Methylphenidate
Hcl)
PS
Risperdal
Remeron
Clonidine
C
C
C
Manufacturer
Route
Manufacturer
Route
108MG (2-54MG
Hostility
TABS) X/1 DAY
Date:03/01/02ISR Number: 3876673-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE00855
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Growth Retardation
Skin Striae
Weight Increased
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Captagon
(Fenetylline
Hydrochloride)
C
Duration
ORAL
18-Aug-2005
Page: 240
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/04/02ISR Number: 3877938-7Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Medication Error
Date:03/04/02ISR Number: 3879763-XReport Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Product
Role
Metadate Er Tablets
(Methylphenidate
Hydrochloride
Extended-Release
Tablets, Usp)
PS
Manufacturer
Route
Route
Duration
PT
Company Report #CTU 162732
Report Source
Product
Role
Manufacturer
Methylphenidate
20mg Sr
PS
Apothecon
Product
Role
Manufacturer
Methylphenidate
10mg Tablets
Schein
PS
Schein
Duration
Abdominal Pain Upper
Agitation
1 Q AM
Disturbance In Attention
Drug Effect Decreased
Mood Altered
Restlessness
Date:03/04/02ISR Number: 3879764-1Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
PT
Report Source
Duration
Abdominal Pain Upper
Agitation
Condition Aggravated
1 TAB
Company Report #CTU 162733
AM,
Disturbance In Attention
2 TABS LUNCH,
Drug Effect Decreased
1 TO 2 AT
Mood Altered
6PM
Restlessness
Route
Date:03/05/02ISR Number: 3879121-8Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #CTU 162836
Report Source
Product
Role
Methylphenidate
(Generic)
PS
Manufacturer
Route
Manufacturer
Route
Duration
Drug Effect Decreased
Pharmaceutical Product
Complaint
Date:03/05/02ISR Number: 3879129-2Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
5MG PO DAILY
PT
Company Report #CTU 162838
Report Source
Drug Effect Decreased
Product
Role
Methylphenidate
PS
ORAL
Drug Tolerance Decreased
Pharmaceutical Product
Complaint
Date:03/06/02ISR Number: 3879623-4Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
- TID
Complaint
18-Aug-2005
Page: 241
Report Source
Product
Role
Ritalin 10 Mg
(Methylphenidate)
PS
Manufacturer
Route
Duration
Drug Ineffective
Pharmaceutical Product
P.O.
Company Report #CTU 162881
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/06/02ISR Number: 3880047-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE00870
Age:44 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Basedow'S Disease
Drug Abuser
Hyperthyroidism
Foreign
Health
Professional
Other
Ritaline
(Methylphenidat
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
5 MG, Q4H,
ORAL
Date:03/06/02ISR Number: 3880565-9Report Type:Expedited (15-DaCompany Report #PHBS2002CA02858
Age:13 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abdominal Pain
Depression
Foreign
Consumer
Other
Ritalin-Sr
(Methylphenidate
Hydrochloride)
PS
Celexa
C
Manufacturer
Route
Manufacturer
Route
Duration
20 MG/DAY
Date:03/06/02ISR Number: 3880576-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE00904
Age:36 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Visual Field Defect
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Duration
80 MG/DAY,
ORAL
Date:03/08/02ISR Number: 3882010-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE00915
Age:14 YR
Gender:Male
I/FU:I
ORAL
Outcome
Dose
Other
PT
Report Source
Product
Role
Hypertension
Hypoaesthesia
Nervous System Disorder
Paraesthesia
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
50MG/DAY,
ORAL
Date:03/11/02ISR Number: 3881514-XReport Type:Direct
Age:18 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
10 PO TIP
PT
Company Report #CTU 163217
Report Source
Product
Role
Drug Effect Decreased
Pharmaceutical Product
Generic
Methylphenidate
PS
Complaint
Buspar
C
Manufacturer
Route
Duration
2
ORAL
MON
Date:03/12/02ISR Number: 3882768-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE00619
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Activated Partial
Thromboplastin Time
Prolonged
Factor Viii Deficiency
Foreign
Health
Professional
Other
Ritalin-Sr
(Methylphenidate
Hydrochloride) Slow
Release Tablet
PS
20 MG, QD,
Haematoma
ORAL
Von Willebrand'S Disease
18-Aug-2005
Page: 242
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/13/02ISR Number: 3883301-5Report Type:Expedited (15-DaCompany Report #12222
Age:39 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
144 MG (36 MG
PT
Report Source
Product
Role
Agitation
Condition Aggravated
Irritability
Consumer
Concerta
(Methylphenidate
Hcl)
PS
Zoloft
Clonazepam
Hydroxyzine
Trazadone
C
C
C
C
Manufacturer
Route
Manufacturer
Route
Memory Impairment
X 4 TAB) 1
Paranoia
X/DAY
Personality Change
Suicidal Ideation
Date:03/14/02ISR Number: 3884852-XReport Type:Expedited (15-DaCompany Report #PHBS2002JP01502
Age:32 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Depressed Level Of
Consciousness
Drug Interaction
Gamma-Glutamyltransferase
Foreign
Literature
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
Unknown
PS
ORAL
Increased
Other
Luvox (Fluvoxamine
Maleate)
SS
ORAL
Tryptanol
(Amitriptyline
Hydrochloride)
SS
ORAL
Wypax (Lorazepam)
SS
ORAL
20 MG/DAY,
ORAL
Hypothermia
Overdose
75 MG/DAY,
Pulmonary Infarction
ORAL
Respiratory Disorder
Somnolence
Speech Disorder
75 MG/DAY,
Stupor
ORAL
Tachycardia
6 MG/DAY,
ORAL
Myonal (Eperisone
Hydrochloride)
SS
ORAL
Perphenazine
(Perphenazine)
SS
ORAL
Lexotan (Bromazepam)
SS
ORAL
Ravona
(Pentobarbital
Calcium)
SS
ORAL
Depas (Etizolam)
SS
ORAL
Halcion (Triazolam)
SS
ORAL
Brovarin
(Bromisoval)
SS
ORAL
300 MG/DAY,
ORAL
3 DF/DAY,
ORAL
15 MG/DAY,
ORAL
150 MG/DAY,
ORAL
6 MG/DAY,
ORAL
0.75 MG/DAY,
ORAL
0.5 G/DAY,
ORAL
Date:03/19/02ISR Number: 3885372-9Report Type:Expedited (15-DaCompany Report #PHBS2002DK01505
Age:
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Eye Pain
Iritis
Foreign
Health
Ritaline(Methylpheni
date Hydrochloride)
PS
40MG/DAY,
Professional
ORAL
Other
18-Aug-2005
Page: 243
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/19/02ISR Number: 3885495-4Report Type:Expedited (15-DaCompany Report #CEL-2002-00037-ROC (0)
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
Required
Intervention to
Prevent Permanent
40 MG
Impairment/Damage
(DAILY), PO
PT
Report Source
Product
Role
Coma
Electroencephalogram
Abnormal
Syncope
Consumer
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Date:03/19/02ISR Number: 3885605-9Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Manufacturer
Route
ORAL
Company Report #CYU 163724
Report Source
Product
Role
Manufacturer
Route
Duration
Drug Ineffective
Pharmaceutical Product
Methylphenidate
Mg
5
PS
5-4-1
Complaint
Date:03/19/02ISR Number: 3885627-8Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 163693
Report Source
Product
Role
Manufacturer
Route
Methyphenidate 5 Mg
Geneva
PS
Geneva
ORAL
Duration
Abnormal Behaviour
Aggression
5 MG 1 Q AM
Condition Aggravated
PO 5 MG 1 PO
Disturbance In Attention
Q LUNCH
Pharmaceutical Product
Complaint
Date:03/19/02ISR Number: 3886090-3Report Type:Expedited (15-DaCompany Report #CEL-2002-00056-ROC(0)
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Crying
Depression
Social Avoidant Behaviour
Suicidal Ideation
Health
Professional
Company
Representative
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
20 MG (20 MG,
QAM), PO
Clonidine
(Clonidine)
Claritin
(Loratadine)
Date:03/20/02ISR Number: 3885669-2Report Type:Direct
Age:4 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Drug Ineffective
Pharmaceutical Product
Complaint
AM 1 1/2 @
18-Aug-2005
Page: 244
C
Company Report #CTU 163780
Report Source
Product
Role
Methylphenidate 10mg
1/2 In Am
PS
Manufacturer
Route
Duration
10 MG 1/2 IN
NOON PO
C
1
MON
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/20/02ISR Number: 3886180-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE01023
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
20MG/DAY,
PT
Report Source
Product
Role
Rhabdomyolysis
Foreign
Health
Professional
Ritaline(Methylpheni
dat Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
Other
ORAL
Date:03/22/02ISR Number: 3886726-7Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11771532
Age:24 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Blood Creatinine
Increased
Blood Pressure Decreased
C-Reactive Protein
Increased
Decubitus Ulcer
Depressed Level Of
Consciousness
Hypoventilation
Lung Infiltration
Pupillary Reflex Impaired
Respiratory Rate
Increased
Suicide Attempt
Product
Role
Manufacturer
Route
Reslin
Sulpiride
Etizolam
Bromperidol
Biperiden Hcl
Ritalin
Flunitrazepam
Erimin
PS
SS
SS
SS
SS
SS
SS
SS
Apothecon
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
Manufacturer
Route
Date:03/22/02ISR Number: 3887726-3Report Type:Expedited (15-DaCompany Report #12499
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Anger
Disturbance In Social
Behaviour
Consumer
Concerta
(Methylphenidate
Hcl)
PS
Duration
18MG 1X/1DAY,
Dysphonia
ORAL
ORAL
Homicidal Ideation
Personality Change
Sleep Disorder
Date:03/25/02ISR Number: 3887763-9Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Minocycline
Company Report #CTU 163979
Report Source
Product
Role
Metadate Er
Tablets(Methylphenid
ate Hydrochloride
Extended-Releas
Tables, Usp)
PS
Duration
Medication Error
Date:03/25/02ISR Number: 3889028-8Report Type:Expedited (15-DaCompany Report #2002091771JP
Age:31 YR
Gender:Male
I/FU:F
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 245
C
11:49 AM
PT
Dehydration
Drug Interaction
Dysarthria
Gamma-Glutamyltransferase
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Increased
Hypothermia
Overdose
Pulmonary Infarction
Report Source
Product
Role
Respiratory Disorder
Somnolence
Foreign
Literature
Halcion (Triazolam)
Tablet
PS
ORAL
Speech Disorder
Stupor
Luvox (Fluvoxamine
Maleate)
SS
ORAL
Tachycardia
Tryptanol
(Amitriptyline
Hydrochloride)
SS
ORAL
Wypax (Lorazepam)
SS
ORAL
Myonal (Eperisone
Hydrochloride)
SS
ORAL
Perphenazine
(Perphenazine)
SS
ORAL
Lexotan (Bromazepam)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
Ravona
(Pentobarbital
Calcium)
SS
ORAL
Depas (Etizolam)
SS
ORAL
Manufacturer
Route
Duration
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
Date:03/26/02ISR Number: 3889090-2Report Type:Expedited (15-DaCompany Report #12222
Age:39 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
144MG(36MGX4T
PT
Report Source
Product
Role
Agitation
Irritability
Memory Impairment
Consumer
Concerta
(Methylphenidate
Hcl)
PS
Manufacturer
Route
Paranoia
AB) 1X/DAY
Personality Change
Suicidal Ideation
Date:03/27/02ISR Number: 3890252-9Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Zoloft
Clonazepam
Hydroxyzine
Trazadone
Company Report #CTU 164348
Report Source
Product
Role
Methylphenidate
Hydrochloride
Extended-Release
Tablets Usp 20mg
PS
Duration
Medication Error
Date:03/27/02ISR Number: 3890931-3Report Type:Expedited (15-DaCompany Report #2002UW02017
Age:31 YR
Gender:Male
I/FU:F
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 246
C
C
C
C
11:49 AM
PT
Body Temperature
Decreased
Dehydration
Depressed Level Of
Consciousness
Dysarthria
Overdose
Po2 Decreased
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Pulmonary Infarction
Refusal Of Treatment By
Patient
Report Source
Product
Role
Respiratory Disorder
Foreign
Elavil
PS
ORAL
Somnolence
Literature
Tachycardia
Health
Luvox
SS
ORAL
Ventilation/Perfusion
Professional
Wypax
SS
ORAL
Scan Abnormal
Other
Myonal
SS
ORAL
Perphenazine
SS
ORAL
Lexotan
SS
ORAL
Halcion
SS
ORAL
Ritalin
SS
ORAL
Ravona
SS
ORAL
Depas
SS
ORAL
Brovarin
SS
ORAL
Manufacturer
Route
Duration
75 MG DAILY
PO
75 MG QD PO
6 MG QD PO
300 MG DAILY
PO
3 DF QD PO
15 MG DAILY
PO
0.75 MG QD PO
20 MG QD PO
150 MG QD PO
6 MG QD PO
0.5 G DAILY
PO
Date:03/27/02ISR Number: 3891242-2Report Type:Expedited (15-DaCompany Report #2002-01-2338
Age:31 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization 3 DF QD ORAL
Initial or Prolonged
75 MG QD ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Dysarthria
Foreign
Perphenazine
PS
ORAL
Electrocardiogram
Literature
Luvox
SS
ORAL
Other
75 MG QD ORAL
Abnormal
Health
Tryptanol
SS
ORAL
Pulmonary Infarction
Professional
Wypax
SS
ORAL
Respiratory Disorder
Other
Myonal
SS
ORAL
Lexotan
SS
ORAL
Halcion
SS
ORAL
Ritalin
SS
ORAL
Ravona
SS
ORAL
Depas
SS
ORAL
Brovarin
SS
ORAL
6 MG QD ORAL
300 MG QD
Somnolence
ORAL
15 MG QD ORAL
0.75 MG QD
ORAL
20 MG QD ORAL
150 MG QD
ORAL
6 MG QD ORAL
0.5 G QD ORAL
Date:03/28/02ISR Number: 3892173-4Report Type:Expedited (15-DaCompany Report #12545
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abdominal Pain
Foreign Body Trauma
Literature
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hcl)
PS
Manufacturer
Route
Manufacturer
Route
Duration
Date:03/29/02ISR Number: 3891960-6Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization 5-10 MG DAY
Initial or Prolonged
INTERMIT ORAL
PT
Delusion
Hallucination
Mania
Psychotic Disorder
Company Report #CTU 164481
Report Source
Product
Role
Ritalin 5mg
PS
ORAL
18-Aug-2005
Page: 247
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/01/02ISR Number: 3893266-8Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 164704
Report Source
Product
Role
Manufacturer
Route
Methylphenidate 10mg
Geneva
PS
Geneva
ORAL
Manufacturer
Route
Manufacturer
Route
Duration
Educational Problem
Pharmaceutical Product
10MG PO TID
Complaint
Date:04/01/02ISR Number: 3893526-0Report Type:Expedited (15-DaCompany Report #12577
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Aplastic Anaemia
Gingival Bleeding
Hepatitis Viral
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Duration
18MG TO
36MG1X/DAY
Date:04/02/02ISR Number: 3893900-2Report Type:Direct
Age:48 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 164736
Report Source
Product
Role
Dexedrine 15mg
PS
ORAL
Desoxyn 15mg
SS
ORAL
Methylphenidate
SS
ORAL
Duration
Bone Marrow Depression
2 TABS TID
Bone Pain
ORAL
Hairy Cell Leukaemia
1 TAB TID
Pancytopenia
ORAL
30-40 MG/ DAY
ORAL
Date:04/02/02ISR Number: 3894266-4Report Type:Expedited (15-DaCompany Report #PHEH2002US02950
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Drug Withdrawal Syndrome
Epilepsy
Consumer
Ritalin
(Methylphenidat)
PS
Manufacturer
Route
Manufacturer
Route
Duration
Date:04/03/02ISR Number: 3895299-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB03375
Age:15 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Cardiac Disorder
Cardiomegaly
Circulatory Collapse
Sudden Death
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Unknown
PS
Duration
ORAL
0, ORAL
Date:04/08/02ISR Number: 3896875-5Report Type:Expedited (15-DaCompany Report #12642
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
36MG 1X/1DAY,
ORAL
18-Aug-2005
Page: 248
11:49 AM
PT
Report Source
Product
Role
Acute Myeloid Leukaemia
Contusion
Consumer
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/08/02ISR Number: 3896924-4Report Type:Expedited (15-DaCompany Report #CEL-2002-00194-ROC (0)
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Balance Disorder
Coma
Crying
Petit Mal Epilepsy
Consumer
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:04/09/02ISR Number: 3897024-XReport Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 165292
Report Source
Product
Role
Manufacturer
Route
Methylphenidate 10
Mg Novartis
PS
Novartis
ORAL
Methylphenidate 10
Mg Novartis
SS
Novartis
ORAL
Manufacturer
Route
Duration
Abnormal Behaviour
Disturbance In Attention
10 MG PO 1 Q
Drug Effect Decreased
AM
Pharmaceutical Product
Complaint
10 MG 1 PO
Q
Psychomotor Hyperactivity
NOON
Restlessness
Date:04/09/02ISR Number: 3897717-4Report Type:Expedited (15-DaCompany Report #CEL-2002-0086-SLO (0)
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
50 MG (10 MG,
FIVE TIMES
DAILY), PO
PT
Report Source
Product
Role
Vision Blurred
Foreign
Health
Professional
Equasym (Strength
Unspecified)
(Methylphenidate
PS
Duration
ORAL
Date:04/10/02ISR Number: 3898153-7Report Type:Expedited (15-DaCompany Report #12784
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Complex Regional Pain
Syndrome
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Neurontin
Nortriptyline
C
C
Manufacturer
Route
Duration
ORAL
18MG 1X/
1DAY, ORAL
Date:04/11/02ISR Number: 3899522-1Report Type:Expedited (15-DaCompany Report #CEL-2002-00214-ROC (0)
Age:18 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 80 MG (40 MG,
Initial or Prolonged
BID), PO
PT
Report Source
Product
Role
Agitation
Health
Metadate Cd
PS
Psychotic Disorder
Professional
Somatic Delusion
Company
Representative
Date:04/11/02ISR Number: 3899523-3Report Type:Expedited (15-DaCompany Report #CEL-2002-00056-ROC(0)
Age:8 YR
Gender:Male
I/FU:F
Outcome
Other
18-Aug-2005
Page: 249
PT
Crying
Depression
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Homicidal Ideation
Self-Injurious Ideation
Social Avoidant Behaviour
Dose
Report Source
Product
Role
Health
Professional
Company
Metade Cd
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
Suicidal Ideation
ORAL
20 MG (20 MG,
Representative
QAM), PO
Clonidine
(Clonidine)
Claritin
(Loratadine)
C
C
Date:04/11/02ISR Number: 3899558-0Report Type:Expedited (15-DaCompany Report #US009560
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization 2 MG QD ORAL
Initial or Prolonged
12 MG TID
PT
Report Source
Product
Role
Manufacturer
Route
Aphasia
Health
Gabitril
PS
ORAL
Convulsion
Professional
Gabitril
SS
ORAL
Depressed Level Of
Company
Consciousness
Representative
Concerta
SS
ORAL
Concerta
SS
ORAL
Zarontin
C
ORAL
36 MG QAM
ORAL
18 MG QHS
ORAL
Date:04/11/02ISR Number: 3899803-1Report Type:Expedited (15-DaCompany Report #CEL-2002-00212-ROC (0)
Age:55 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Affective Disorder
Agitation
Health
Professional
Metadate Cd Capsules
20 Mg
Duration
Role
Manufacturer
Route
Excitability
Irritability
Company
Representative
(Methylphenidate
Hydrochloride)
PS
Methylphenidate
Tablets
(Methylphenidate
Hydrochloride)
SS
ORAL
(BID), PO
Date:04/12/02ISR Number: 3899673-1Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 165582
Report Source
Product
Role
Methylphenidate
PS
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
Pharmaceutical Product
Complaint
Date:04/16/02ISR Number: 3901883-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE01236
Age:33 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Csf Oligoclonal Band
Present
Multiple Sclerosis
Optic Neuritis
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
ORAL
Retrobulbar
Visual Disturbance
18-Aug-2005
Page: 250
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/16/02ISR Number: 3902185-XReport Type:Expedited (15-DaCompany Report #PHBS2002BR01038
Age:28 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Anorexia
Anxiety
Crying
Depressed Mood
Foreign
Consumer
Other
Ritalina
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
10 MG, BID,
Dry Mouth
ORAL
Dysphemia
Hyperhidrosis
Mood Swings
Nervousness
Tachycardia
Tremor
Flurazepam
(Flurazepam0
Tryptanol
(Amitriptyline
Hydrochloride)
Tablet
C
C
Date:04/17/02ISR Number: 3902495-6Report Type:Expedited (15-DaCompany Report #CEL-2002-00263-ROC (0)
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
Required
SEE IMAGE
Intervention to
Prevent Permanent
Impairment/Damage
PT
Report Source
Product
Role
Manufacturer
Route
Dialysis
Nephrotic Syndrome
Renal Failure Chronic
Consumer
Health
Professional
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
ORAL
Metadate Er Tablets
20 Mg
(Methylphenidate
Hydrochloride)
SS
ORAL
Albuterol
(Salbutamol)
Singulair
SS
C
SEE IMAGE
Date:04/18/02ISR Number: 3901933-2Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #CTU 166047
Report Source
Product
Role
Manufacturer
Route
Other
Condition Aggravated
Drug Effect Decreased
Methylphenidate 10mg
Apothecon
PS
Apothecon
ORAL
Product
Role
Manufacturer
Route
Methylpenidate 5mg
Tabs (Generic)
PS
Manufacturer
Route
10MG Q AM,
Irritability
10MG Q NOON
PO
Date:04/18/02ISR Number: 3902426-9Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 166099
Report Source
Duration
Drug Ineffective
Pharmaceutical Product
3 TABS BID
Complaint
Date:04/18/02ISR Number: 3902428-2Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Methylpenidate 20
Mg Tabs (Generic
PS
Duration
Drug Ineffective
Pharmaceutical Product
20 MG TID
Complaint
18-Aug-2005
Page: 251
Company Report #CTU 166100
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/18/02ISR Number: 3903039-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE00915
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Antibody Test Positive
Complement Factor
Increased
Herpes Zoster
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Talbet
PS
Manufacturer
Route
ORAL
ORAL; 60
Hypertension
MG/DAY, ORAL
Hypoaesthesia
Inflammation
Nervous System Disorder
Paraesthesia
Date:04/18/02ISR Number: 3903102-9Report Type:Expedited (15-DaCompany Report #PHBS2002AU04398
Age:7 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Dry Skin
Movement Disorder
Nightmare
Foreign
Consumer
Other
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Efalex (Evening
Primrose Oil,
Omega-3 Marine
Triglycerides, Thyme
Oil)
C
Manufacturer
Route
Duration
ORAL
10 MG/DAY
Rash
ORAL
Sleep Terror
Tic
Date:04/22/02ISR Number: 3904542-4Report Type:Expedited (15-DaCompany Report #CEL-2002-00284-ROC (0)
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Aggression
Hallucination
Insomnia
Consumer
Metadate Cd Capsules
20 Mg
(Methylphenidate
Duration
Role
Manufacturer
Route
Psychomotor Hyperactivity
Hydrochloride)
PS
Zoloft (Sertraliine
Hydrochloride)
Ddavp (Desmopressin)
C
C
ORAL
20 MG (20 MG,
Vision Blurred
EVERY AM), PO
Date:04/23/02ISR Number: 3906679-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE01357
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Intentional Misuse
Suicide Attempt
Tachycardia
Foreign
Health
Professional
Ritalin(Methylphenid
ate Hydrochloride)
Tablet, 10mg
PS
Manufacturer
Route
ORAL
SEE IMAGE
Other
Date:04/23/02ISR Number: 3906732-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE01391
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Concussion
Fall
Tinnitus
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
5 MG/DAY,
Other
ORAL
18-Aug-2005
Page: 252
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/23/02ISR Number: 3906733-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE01373
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Glucose Increased
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
ORAL
Other
Date:04/23/02ISR Number: 3906735-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE01023
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
20MG/DAY,
PT
Report Source
Product
Role
Rhabdomyolysis
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
Other
ORAL
Date:04/25/02ISR Number: 3906986-3Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 166591
Report Source
Product
Role
Ritalin 10 Mg
Generic
PS
Manufacturer
Route
Duration
Drug Ineffective
ORAL
10 MG PO BID
Date:04/26/02ISR Number: 3907934-2Report Type:Expedited (15-DaCompany Report #PHRM2002FR01172
Age:53 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Movement Disorder
Paraesthesia
Foreign
Consumer
Other
Ritaline
(Methylphenidate
Hydrochloride)
Role
Manufacturer
Route
Tablet
PS
Levothyrox
Teralithe
Effexor (Venlafaxine
Hydrochloride)
C
C
ORAL
20 MG, BID,
ORAL
C
Date:04/26/02ISR Number: 3908135-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE01407
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Glucose Increased
Diabetes Mellitus
Glycosylated Haemoglobin
Increased
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
10 MG TID
Hypertriglyceridaemia
ORAL
Thirst
Weight Decreased
Date:04/26/02ISR Number: 3908801-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE01236
Age:33 YR
Gender:Male
I/FU:F
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 253
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Other
Dose
PT
Report Source
Product
Role
Csf Oligoclonal Band
Present
Multiple Sclerosis
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Optic Neuritis
Retrobulbar
Visual Disturbance
Other
Manufacturer
Route
Duration
ORAL
ORAL
Date:04/29/02ISR Number: 3908383-3Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 166767
Report Source
Product
Role
Concerta
Depakote
Wellbutrin Sr
PS
C
C
Manufacturer
Route
Manufacturer
Route
Duration
Hallucination
Date:04/30/02ISR Number: 3911387-8Report Type:Expedited (15-DaCompany Report #12785
Age:18 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hepatic Failure
Health
Professional
Company
Concerta
(Methylphenidate
Hcl)
PS
Celebrex
C
Duration
ORAL
18MG 1X/1 DAY
Representative
ORAL
Date:05/01/02ISR Number: 3910574-2Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
ORAL
PT
Company Report #CTU 167149
Report Source
Product
Role
Generic Ritalin
PS
Manufacturer
Route
Duration
Abnormal Behaviour
1
MON
ORAL
Condition Aggravated
Drug Ineffective
Educational Problem
Pharmaceutical Product
Complaint
Date:05/01/02ISR Number: 3911122-3Report Type:Expedited (15-DaCompany Report #PHBS2002CA05190
Age:18 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Depression
Foreign
Health
Professional
Ritalin-Sr
(Methylphenidate
Hydrochloride)
Tablet
PS
180MG/DAY,
ORAL
Date:05/01/02ISR Number: 3911124-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB01415
Age:6 YR
Gender:Female
I/FU:I
Outcome
Other
18-Aug-2005
Page: 254
Manufacturer
Route
Duration
PT
Attention
Deficit/Hyperactivity
Disorder
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Muscle Twitching
Restlessness
Screaming
Dose
Report Source
Product
Role
Foreign
Health
Professional
Other
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
Urinary Incontinence
ORAL
5MG/DAY, ORAL
Date:05/01/02ISR Number: 3911156-9Report Type:Expedited (15-DaCompany Report #PHBS2002AU04398
Age:7 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Dry Skin
Movement Disorder
Nightmare
Rash
Foreign
Consumer
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Efalex (Evening
Primrose Oil,
Omega-3 Marine
Triglycerides, Thyme
Oil)
C
Manufacturer
Route
Duration
ORAL
10MG/DAY,
Sleep Terror
ORAL
Tic
Date:05/01/02ISR Number: 3911195-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB01418
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Electrocardiogram Qt
Prolonged
Foreign
Health
Professional
Ritaline(Methylpheni
dat Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
Date:05/01/02ISR Number: 3911413-6Report Type:Expedited (15-DaCompany Report #12965
Age:15 YR
Gender:Male
I/FU:I
ORAL
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
54MG 1X/1DAY
PT
Report Source
Product
Role
Fatigue
Pancreatitis Acute
Consumer
Concerta
(Methylphenidate
Hcl)
PS
Date:05/03/02ISR Number: 3911656-1Report Type:Direct
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Manufacturer
Route
Manufacturer
Route
Company Report #CTU 167241
Report Source
Product
Role
Ritalin (Generic) Sr
20mg Tabs
PS
Duration
Drug Effect Decreased
ORAL
20MG 2 PO QD
Date:05/06/02ISR Number: 3912489-2Report Type:Direct
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 167392
Report Source
Product
Role
Manufacturer
Methylphenidate 10
Mg Watson
PS
Watson
Concerta
C
Duration
Drug Effect Decreased
Pharmaceutical Product
10 MG IN AM
Complaint
AND
AFTERNOON/
5-6 MONTHS
18-Aug-2005
Page: 255
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Tenex
C
Date:05/07/02ISR Number: 3913418-8Report Type:Expedited (15-DaCompany Report #PHNU2002DE01517
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Infection
Myositis
Pain In Extremity
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
20MG/DAY,
Other
ORAL
Date:05/07/02ISR Number: 3913722-3Report Type:Expedited (15-DaCompany Report #PHFR2001GB03227
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Eosinophil Count
Decreased
Epistaxis
Lymphocyte Count
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
ORAL
Decreased
Neutropenia
Pharyngolaryngeal Pain
White Blood Cell Count
Decreased
Date:05/07/02ISR Number: 3913723-5Report Type:Expedited (15-DaCompany Report #PHBS2002CA05418
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Haemolytic Anaemia
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
PS
Duration
Manufacturer
Route
Date:05/07/02ISR Number: 3913901-5Report Type:Expedited (15-DaCompany Report #A209655
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Required
Intervention to
20.00
Prevent Permanent
MG/TOTAL/DAIL
Impairment/Damage
Y/ORAL
PT
Report Source
Product
Role
Abnormal Behaviour
Aggression
Health
Professional
Zoloft Tablets
Methylphenidate
PS
SS
Desmopressin
C
PT
Company Report #CTU 167511
Report Source
Product
Role
Abnormal Behaviour
Ritalin Sr 20mg Bid
PS
Aggression
Pharmaceutical Product
Ritalin 15mg Tid
(10mg Tab)
SS
Duration
WK
15MG TID
Complaint
18-Aug-2005
Page: 256
11:49 AM
ORAL
Insomnia
Date:05/08/02ISR Number: 3913190-1Report Type:Direct
Age:17 YR
Gender:Male
I/FU:I
3
Route
Hallucination
Psychomotor Hyperactivity
Pyromania
Vision Blurred
Outcome
Dose
Other
20MG BID
Manufacturer
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/08/02ISR Number: 3913261-XReport Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #USP 54855
Report Source
Product
Role
Manufacturer
PS
Medeva
SS
Alltech
Product
Role
Manufacturer
Ritalin 10 Mg
PS
Route
Duration
Medication Error
Date:05/08/02ISR Number: 3914332-4Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
10 MG PO BID
PT
Metadate Er
(Methylphemadate
Hydrochloride)
Metadate Cd
(Methylphemadate
Hydrochloride)
Company Report #CTU 167668
Report Source
Drug Ineffective
Route
ORAL
Date:05/09/02ISR Number: 3915338-1Report Type:Expedited (15-DaCompany Report #12784
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
18 MG 1X/1DAY
Other
ORAL
PT
Report Source
Product
Role
Complex Regional Pain
Syndrome
Health
Professional
Concerta(Methylpheni
date Hcl)
PS
Neurontin
Nortriptyline
C
C
Manufacturer
Route
ORAL
Date:05/09/02ISR Number: 3915441-6Report Type:Expedited (15-DaCompany Report #PHRM2002FR01329
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Alanine Aminotransferase
Increased
Aspartate
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
Duration
Role
Manufacturer
Route
Aminotransferase
Tablet
PS
ORAL
Drug Interaction
Hepatic Enzyme Increased
Dafalgan
(Paracetamol)
SS
ORAL
Hyperpyrexia
Lung Disorder
Augmentin
(Clavulanate
Potassium)
C
5 MG, BID,
Increased
ORAL
ORAL
Date:05/14/02ISR Number: 3916573-9Report Type:Expedited (15-DaCompany Report #13166
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Convulsion
Health
Professional
Company
Concerta
(Methylphenidate
Hcl)
PS
Representative
Ritalin
C
Duration
54MG 1X/1DAY
Date:05/14/02ISR Number: 3916619-8Report Type:Expedited (15-DaCompany Report #CEL-2002-00364-ROC(0)
Age:33 YR
Gender:Female
I/FU:I
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 257
11:49 AM
PT
Blood Pressure Increased
Dizziness
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Orthostatic Hypotension
Rash
Dose
Report Source
Product
Role
Health
Professional
Company
Metadate Cd
(Methylphenidate
Hydrochloride)
PS
Paxil (Paroxetine
Hydrochloride)
C
Manufacturer
Route
Duration
ORAL
20 MG (20 MG,
Representative
TWICE A DAY),
PO
Date:05/14/02ISR Number: 3916621-6Report Type:Expedited (15-DaCompany Report #CEL-2002-00388-ROC(0)
Age:45 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Convulsion
Consumer
Health
Professional
Metadate Cd
20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
20 MG (20 MG,
Company
DAILY), PO
4
DAY
Representative
Verapamil
(Verapamil)
Proventil
(Salbutamol)
Motrin (Ibuprofen)
C
C
C
Date:05/14/02ISR Number: 3916622-8Report Type:Expedited (15-DaCompany Report #CEL-2002-00194-ROC(1)
Age:5 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
1/2 CAPSULE,
PT
Report Source
Product
Role
Convulsion
Petit Mal Epilepsy
Consumer
Health
Professional
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
PO:20MG QD,PO
Date:05/14/02ISR Number: 3916937-3Report Type:Expedited (15-DaCompany Report #12785
Age:18 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
18 MG
PT
Report Source
Product
Role
Abdominal Pain
Hepatic Failure
Vomiting
Health
Professional
Company
Concerta
(Methylphenidate
Hcl)
PS
Celebrex
C
Manufacturer
Route
ORAL
Representative
1X/1DAY, ORAL
Date:05/15/02ISR Number: 3917456-0Report Type:Expedited (15-DaCompany Report #12965
Age:15 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
54MG 1X/1DAY
18-Aug-2005
Page: 258
11:49 AM
PT
Report Source
Product
Role
Pancreatitis Acute
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/16/02ISR Number: 3917822-3Report Type:Expedited (15-DaCompany Report #A0367651A
Age:33 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Blood Potassium Decreased
Dehydration
Dizziness
Health
Professional
Company
Paxil (Formulation
Unknown) (Paroxetine
Hydrochloride)
PS
ORAL
Mitral Valve Prolapse
Nervous System Disorder
Orthostatic Hypotension
Tachycardia
Representative
Methylphenidate Hcl
(Formulation
Unknown)
(Methylphenidate
Hcl)
SS
ORAL
Clozapine
(Formulation Unkown)
(Clozapine)
SS
ORAL
ORAL
ORAL
ORAL
Date:05/17/02ISR Number: 3918783-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE01592
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abscess Limb
Red Blood Cell
Sedimentation Rate
Increased
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
1 DF, QD,
White Blood Cell Count
ORAL
Decreased
Date:05/17/02ISR Number: 3918918-2Report Type:Expedited (15-DaCompany Report #12642
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
36MG 1X/1DAY,
PT
Report Source
Product
Role
Acute Myeloid Leukaemia
Consumer
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Manufacturer
Route
ORAL
ORAL
Date:05/20/02ISR Number: 3918860-7Report Type:Direct
Age:13 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #CTU 168426
Report Source
Product
Role
Abnormal Behaviour
Aggression
Agitation
Metadate Cd
(Methylphenidate
Extended Release)
PS
Decreased Appetite
Headache
Psychomotor Hyperactivity
Screaming
Trazodone
C
Manufacturer
Route
Manufacturer
Route
Duration
40 MG Q AM
Date:05/20/02ISR Number: 3919280-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE01646
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Depression
Suicide Attempt
Foreign
Consumer
Other
Ritalin(Methylphenid
at Hydrochloride)
Tablet, 10 Mg
PS
L-Thyroxin
C
Duration
10 MG, QID,
ORAL
18-Aug-2005
Page: 259
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/20/02ISR Number: 3919321-1Report Type:Direct
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
20MG 3 PO QD
PT
Company Report #CTU 168453
Report Source
Drug Effect Decreased
Product
Role
Ritalin(Generic) Sr
PS
Manufacturer
Route
ORAL
Pharmaceutical Product
DAILY
Complaint
Date:05/20/02ISR Number: 3919345-4Report Type:Expedited (15-DaCompany Report #12863
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abnormal Behaviour
Palpitations
Paranoia
Consumer
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Manufacturer
Route
Duration
ORAL
54MG 1X/
1DAY, ORAL
Date:05/20/02ISR Number: 3919505-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE01637
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Dermatomyositis
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
10 TO 15
MG/DAY, ORAL
Date:05/22/02ISR Number: 3922336-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE00904
Age:36 YR
Gender:Male
I/FU:F
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Other
Optic Neuritis
Visual Field Defect
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
ORAL
80 MG/DAY,
Other
ORAL
Date:05/22/02ISR Number: 3922401-8Report Type:Expedited (15-DaCompany Report #PHNU2002DE01666
Age:15 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Shock
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Slow Release Tablet
PS
Manufacturer
Route
Duration
ORAL
15 MG/DAY;
Other
ORAL
Date:05/22/02ISR Number: 3922402-XReport Type:Expedited (15-DaCompany Report #PHNU2002DE01667
Age:23 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Aggression
Depression
Psychotic Disorder
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
30 MG/DAY,
Other
ORAL
18-Aug-2005
Page: 260
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/23/02ISR Number: 3921807-0Report Type:Expedited (15-DaCompany Report #12863
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Bruxism
Hallucination
Hyperhidrosis
Consumer
Health
Professional
Concreta
(Methylphenidate
Hcl)
PS
Manufacturer
Route
Duration
ORAL
54MG
Overdose
1X/DAY,ORAL
Palpitations
Paranoia
Date:05/24/02ISR Number: 3922960-5Report Type:Expedited (15-DaCompany Report #12784
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
18MG 1X/1DAY,
PT
Report Source
Product
Role
Complex Regional Pain
Syndrome
Health
Professional
Concerta
(Methylphenidate
Hc1)
PS
Neurontin
Nortriptyline
C
C
Manufacturer
Route
ORAL
ORAL
Date:05/28/02ISR Number: 3923383-5Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 168983
Report Source
Product
Role
Methylphenidate
PS
Duration
Drug Ineffective
Pharmaceutical Product
Complaint
Date:05/29/02ISR Number: 3925231-6Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Company Report #CTU 169114
Manufacturer
Route
Outcome
Dose
PT
Report Source
Drug Ineffective
PO 20 MG TID
Product
Role
Ritalin Generic Form
PS
Manufacturer
Route
Duration
4
ORAL
WK
Pharmaceutical Product
Complaint
Date:05/29/02ISR Number: 3926275-0Report Type:Expedited (15-DaCompany Report #PHBS2002BE06071
Age:14 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abdominal Pain
Hepatitis
Nausea
Foreign
Consumer
Other
Ritaline
(Methylphenidate
Hydrochloride)
PS
25 MG/DAY,
ORAL
Date:05/31/02ISR Number: 3926900-4Report Type:Expedited (15-DaCompany Report #200215052US
Age:10 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 261
PT
Abnormal Behaviour
Aggression
Hallucination
Injury
Insomnia
Psychomotor Hyperactivity
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Vision Blurred
Report Source
Dose
Product
Role
Manufacturer
Desmopressin (Ddavp)
Tablets
PS
ORAL
Methylphenidate
Hydrochloride
Capsules
SS
ORAL
Sertraline
Hydrochloride
(Zoloft)
C
Route
Duration
PO
20 MG QAM PO
3
DAY
Date:05/31/02ISR Number: 3927123-5Report Type:Expedited (15-DaCompany Report #13166
Age:5 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Convulsion
Grand Mal Convulsion
Health
Professional
Concerta(Methylpheni
date Hcl)
PS
Petit Mal Epilepsy
Company
Ritalin
C
Manufacturer
Route
Duration
ORAL
54MG 1X/1DAY,
PO
Representative
Date:06/03/02ISR Number: 3926877-1Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
54MG 1 Q DAY
PT
Aggression
Anhedonia
ORAL
Anxiety
Decreased Appetite
Depression
Feeling Of Despair
Irritability
Suicidal Ideation
Company Report #CTU 169351
Report Source
Product
Role
Concerta 54mg
PS
Manufacturer
Route
ORAL
Date:06/03/02ISR Number: 3968568-7Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #12551
PT
Report Source
Product
Role
Leukopenia
Health
Professional
Concerta
(Methylphenidate
Hci)
PS
Manufacturer
Route
Manufacturer
Route
Duration
36MG 1X/1 DAY
Date:06/03/02ISR Number: 3968570-5Report Type:Periodic
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abdominal Pain
Anorexia
Insomnia
Consumer
Health
Professional
Concerta
(Methylphenidate
Hc1)
PS
Duration
54MG 1X/1DAY,
Weight
ORAL
18-Aug-2005
Page: 262
Company Report #12636
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/03/02ISR Number: 3968575-4Report Type:Periodic
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
Company Report #12640
PT
Report Source
Product
Role
Hallucination
Consumer
Concerta
(Methylphenidate
Hc1)
PS
Manufacturer
Route
Duration
ORAL
36MG 1X/1
DAY; ORAL
Date:06/03/02ISR Number: 3968579-1Report Type:Periodic
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #13104
PT
Report Source
Product
Role
Convulsion
Health
Professional
Concerta
(Methylphenidate
Hc1)
PS
Manufacturer
Route
Duration
ORAL
36MG 1X/1DAY,
ORAL
Date:06/04/02ISR Number: 3928278-9Report Type:Expedited (15-DaCompany Report #USA-2002-0001129
Age:48 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
MG
PT
Report Source
Product
Role
Alcohol Problem
Biliary Cirrhosis
Hepatic Failure
Overdose
Health
Professional
Oxycontin
Tablets(Oxycodon
Hydrochloride) Cr
Tablet
PS
Ritalin(Methylphenid
ate Hydrochloride)
Cocaine(Cocaine)
Insulin (Insulin)
SS
SS
C
Duration
UNKNOWN
Date:06/04/02ISR Number: 3928967-6Report Type:Expedited (15-DaCompany Report #PHBS2002BE06222
Age:9 YR
Gender:Male
I/FU:U
Manufacturer
Route
Outcome
Dose
Other
PT
Report Source
Product
Role
Accommodation Disorder
Binocular Eye Movement
Disorder
Visual Disturbance
Foreign
Consumer
Other
Ritaline
(Methylphenidate
Hydrochloride)
Unknown
PS
Zyrtec (Cetirizine
Hydrochloride)
C
Manufacturer
Route
Duration
ORAL
10 MG, BID,
ORAL
Date:06/05/02ISR Number: 3928552-6Report Type:Direct
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
2 TABS Q AM
PT
Company Report #CTU 169572
Report Source
Product
Role
Ritalin 20 Mg Sr Po
PS
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
Pharmaceutical Product
Complaint
Date:06/05/02ISR Number: 3929863-0Report Type:Expedited (15-DaCompany Report #CEL-2002-00466-ROC(0)
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 263
PT
Report Source
Product
Drug Interaction
Dysphoria
Health
Professional
Metadate Cd Capsules
20 Mg
Duration
11:49 AM
Role
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
(Methylphenidate
Hydrochloride)
PS
ORAL
Allegra
(Fexofenadine
Hydrochloride)
SS
ORAL
Augmentin (Clavulin)
C
20 MG (20 MG,
Q AM), PO
60 MG (30 MG,
TWICE QD), PO
Date:06/07/02ISR Number: 3934082-8Report Type:Expedited (15-DaCompany Report #B0269193A
Age:42 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
PER DAY/ ORAL
PT
Report Source
Product
Role
Gingival Bleeding
Hepatocellular Damage
Idiopathic
Foreign
Health
Professional
Paxil Tablet
(Paroxetine
Hydrochloride)
PS
Thrombocytopenic Purpura
Company
Representative
Methylphenidate Hcl
(Formulation
Unknown)
(Methylphenidate
Hcl)
Magnesium Oxide
SS
C
Date:06/10/02ISR Number: 3930890-8Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Dyspepsia
Flatulence
Nausea
Pharmaceutical Product
Complaint
Route
ORAL
Company Report #CTU 169806
Report Source
Product
Role
Methylphenidate
PS
Duration
10MG TID
Manufacturer
Manufacturer
Route
Date:06/12/02ISR Number: 3931663-2Report Type:Direct
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
3 TABS Q AM
PT
Company Report #CTU 169942
Report Source
Product
Role
Ritalin 20mg Sr
PS
Manufacturer
Route
Duration
Aggression
ORAL
Disturbance In Attention
PO
Drug Ineffective
Pharmaceutical Product
Complaint
Date:06/12/02ISR Number: 3932830-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB00758
Age:
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Systemic Lupus
Erythematosus
Foreign
Health
Ritaline(Methylpheni
date Hydrochloride)
PS
Duration
40 MG, QD
Professional
Other
18-Aug-2005
Page: 264
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/12/02ISR Number: 3932906-1Report Type:Expedited (15-DaCompany Report #PHEH2002US04957
Age:74 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Syncope
Health
Professional
Ritalin(Methylphenid
ate Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
5 MG, 2-3
TIMES DAILY,
ORAL
Zoloft (Sertraline
Hydrochloride)
Lipitor
(Atorvastatin)
Prevacid
(Lansoprazole)
C
C
C
Date:06/12/02ISR Number: 3933230-3Report Type:Expedited (15-DaCompany Report #13400
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hypoglycaemia
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Manufacturer
Route
Duration
ORAL
36MG 1X/DAY,
ORAL
Date:06/12/02ISR Number: 3933261-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE01874
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
ORAL; SEE
PT
Report Source
Product
Role
Obsessive-Compulsive
Disorder
Foreign
Consumer
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
IMAGE
Ritalin-Sr
(Methylphenidate
Hydrochloride) Slow
Release Tablet
SS
ORAL
ORAL; SEE
IMAGE
Date:06/12/02ISR Number: 3933267-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE01895
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Aggression
Depressed Mood
Tearfulness
Foreign
Other
Ritalin
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:06/12/02ISR Number: 3933349-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE01782
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
ORAL
PT
Report Source
Product
Role
Electrocardiogram
Abnormal
Pulmonary Hypertension
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Other
18-Aug-2005
Page: 265
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/12/02ISR Number: 3933635-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB01687
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Dysarthria
Speech Disorder
Foreign
Health
Professional
Methylphenidate
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
36MG/DAY,
Other
ORAL
Date:06/14/02ISR Number: 3934694-1Report Type:Expedited (15-DaCompany Report #13467
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Influenza Like Illness
Platelet Count Decreased
Pyrexia
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Manufacturer
Route
Manufacturer
Route
Duration
18MG TO 36MG
White Blood Cell Count
1X/1DAY
Decreased
Date:06/14/02ISR Number: 3934695-3Report Type:Expedited (15-DaCompany Report #13483
Age:38 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Arthralgia
Iron Deficiency Anaemia
Pruritus
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Ortho-Tri-Cyclen
Celexa
Seroquel
Nexium
Singulair
Advair
Nasonex
SS
C
C
C
C
C
C
Duration
54MG 1X/DAY,
Red Blood Cell
ORAL
Sedimentation Rate
Increased
Serum Sickness
Urticaria
ORAL
Albuterol
Date:06/14/02ISR Number: 3978957-2Report Type:Periodic
Age:
Gender:Female
I/FU:I
Outcome
PT
Dose
Duration
Other
Convulsion
SUBCUTANEOUS
25 MG, BIW,
C
Company Report #02040196
Report Source
Product
Role
Health
Enbrel 25 Mg
PS
Concerta
SS
Loratadine
Ibuprofen
Diphenhydramine
C
C
C
Professional
SUBCUTANEOUS
SUBCUTANEOUS
25 MG, BIW,
SUBCUTANEOUS
Date:06/17/02ISR Number: 3934799-5Report Type:Direct
Age:42 YR
Gender:Female
I/FU:I
Outcome
Hospitalization Initial or Prolonged
Disability
Required
Intervention to
Prevent Permanent
18-Aug-2005
Page: 266
11:49 AM
Company Report #CTU 170281
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Impairment/Damage
PT
Dose
Report Source
Product
Role
Ritalin
Adderall
PS
SS
Manufacturer
Route
Manufacturer
Route
Duration
Anger
Bipolar Disorder
Crying
Fear
Feeling Abnormal
Hallucination, Auditory
Loss Of Employment
Memory Impairment
Paranoia
Personality Change
Thinking Abnormal
Date:06/18/02ISR Number: 3936126-6Report Type:Expedited (15-DaCompany Report #PHRM2001FR02804
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Decreased Appetite
Hypertension
Tachycardia
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Weight Decreased
Other
Duration
ORAL
SEE IMAGE
Date:06/19/02ISR Number: 3936538-0Report Type:Expedited (15-DaCompany Report #NSADSS2002020120
Age:38 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
Required
Intervention to
Prevent Permanent
1 TABLE,
Impairment/Damage
DAILY, ORAL
PT
Report Source
Product
Role
Arthralgia
Iron Deficiency Anaemia
Pruritus
Red Blood Cell
Health
Professional
Ortho Tri-Cyclen
(Tablet)
(Norgestimate/Ethiny
lestradiol)
PS
Sedimentation Rate
Increased
Serum Sickness
Urticaria
Concerta (54 Mg
Tablet)
(Methylphenidate
Manufacturer
Route
ORAL
Hydrochloride)
SS
ORAL
54 MG, 1 IN 1
DAILY, ORAL
Celexa (Citalopram
Hydrobromide)
Seroquel (Seroquel)
Singulair
(Montelukast Sodium)
Advair
Nasonex (Mometasone
Furoate)
Albuterol
(Salbutamol)
C
C
C
C
C
C
Date:06/21/02ISR Number: 3937806-9Report Type:Expedited (15-DaCompany Report #13624
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36MG 1X/1DAY
PT
Report Source
Product
Role
Abdominal Pain Upper
Consumer
Concerta
PS
Grand Mal Convulsion
ORAL
18-Aug-2005
Page: 267
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/25/02ISR Number: 3938541-3Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
1-1 1/2 TAB
PT
Company Report #CTU 170809
Report Source
Product
Role
Ritalin 10mg
PS
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
Pharmaceutical Product
AFTER SCHOOL
Complaint
Date:06/25/02ISR Number: 3938565-6Report Type:Direct
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 170814
Report Source
Product
Role
Concerta 54 Mg 1 Po
Qam
PS
Duration
Abdominal Pain Upper
Jaundice
ORAL
1 PO QAM
Liver Function Test
Abnormal
Malaise
Pyrexia
Rash
Date:06/25/02ISR Number: 3939623-2Report Type:Expedited (15-DaCompany Report #13693
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Aphasia
Complex Partial Seizures
Convulsion
Health
Professional
Company
Concerta
(Methylphenidate
Hci)
PS
Depressed Level Of
Representative
Gabitril
SS
Zarontin
C
36MG QAM+18MG
QPM
Consciousness
2MG QD TO
Petit Mal Epilepsy
12MG TID
Status Epilepticus
Manufacturer
Route
Date:06/25/02ISR Number: 3939624-4Report Type:Expedited (15-DaCompany Report #13624
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abdominal Pain Upper
Grand Mal Convulsion
Consumer
Concerta
(Methylphenidate
Hcl)
PS
Manufacturer
Route
Duration
ORAL
36MG 1X/1DAY,
ORAL
Date:06/25/02ISR Number: 3940388-9Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
Disability
Required
Intervention to
Prevent Permanent
Impairment/Damage
18-Aug-2005
Page: 268
11:49 AM
PT
Insomnia
Irritability
Self-Injurious Ideation
Sleep Terror
Tourette'S Disorder
Company Report #CTU 170847
Report Source
Product
Role
Ritalin
PS
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/26/02ISR Number: 3940262-8Report Type:Expedited (15-DaCompany Report #PHNU2002DE02013
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
1 DF, QD,
PT
Report Source
Product
Role
Manufacturer
Route
Obsessive-Compulsive
Foreign
Ritaline
PS
ORAL
Disorder
Consumer
Ritalin-Sr
(Methylphenidate
Hydrochloride) Slow
Release
SS
ORAL
Duration
ORAL
Other
1 DF, QD,
ORAL
Date:06/26/02ISR Number: 3940305-1Report Type:Expedited (15-DaCompany Report #13715
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
54MG 1X/1DAY,
PT
Report Source
Product
Role
Grand Mal Convulsion
Vomiting
Foreign
Health
Professional
Concerta
(Methylphenidate
Mcl)
PS
Fluoxetine
SS
Fluoxetine
SS
Lactulose
C
Manufacturer
Route
ORAL
ORAL
4MG 1X/1DAY
12MG 1X/1DAY
Date:06/26/02ISR Number: 3940488-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB01755
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Cyanosis
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydorochloride)
Duration
Role
Manufacturer
Route
Other
Tablet
PS
ORAL
ORAL
Date:06/27/02ISR Number: 3940940-0Report Type:Expedited (15-DaCompany Report #872475F001
Age:25 YR
Gender:Female
I/FU:F
Outcome
Dose
Death
INTRAVENOUS
PT
Report Source
Product
Role
Literature
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Manufacturer
Route
Duration
Bundle Branch Block
Cardiomegaly
Dissociative Disorder
Drug Abuser
INTRAVENOUS
Dyspnoea
Granuloma
Hypotension
Liver Disorder
Pulmonary Granuloma
Tachycardia
Ventricular Hypertrophy
Talwin Tablet
Darvon-N Tablet
Acetaminophen
(Acetaminophen
(Paracetamol))
Tablet
C
C
C
Date:06/27/02ISR Number: 3941374-5Report Type:Expedited (15-DaCompany Report #PHBS2002BE06071
Age:14 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
25 MG/DAY,
ORAL
18-Aug-2005
Page: 269
11:49 AM
PT
Report Source
Product
Role
Abdominal Pain
Hepatitis
Nausea
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Unknown
PS
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/28/02ISR Number: 3941498-2Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
1-1 1/2 TAB
PT
Company Report #CTU 171264
Report Source
Product
Role
Ritalin 10 Mg
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
Pharmaceutical Product
AFTER SCHOOL
Complaint
Date:07/01/02ISR Number: 3941974-2Report Type:Direct
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 171286
Report Source
Product
Role
Ritalin
PS
Duration
Attention
10 MG 1 1/2
Deficit/Hyperactivity
TABS TID
Disorder
Condition Aggravated
Pharmaceutical Product
Complaint
Date:07/01/02ISR Number: 3943032-XReport Type:Expedited (15-DaCompany Report #CEL-2002-00206-SLO (0)
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Attention
Deficit/Hyperactivity
Disorder
Condition Aggravated
Foreign
Health
Professional
Equasym (Strength
Unspecified)
(Methylphenidate
Hydrochloride)
PS
Ritalin
(Methylphenidate
Hydrochloride)
C
Duration
60 MG (20 MG,
Drug Ineffective
THREE TIMES
Emotional Disorder
DAILY), PO
Tic
ORAL
Date:07/01/02ISR Number: 3943805-3Report Type:Expedited (15-DaCompany Report #PHBS2002CA05418
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Haemolytic Anaemia
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Unknown
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:07/02/02ISR Number: 3943518-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB01989
Age:20 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Obsessive-Compulsive
Disorder
Psychotic Disorder
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
60MG/DAY,
Other
ORAL
Date:07/02/02ISR Number: 3943692-3Report Type:Expedited (15-DaCompany Report #13754
Age:14 YR
Gender:Female
I/FU:I
Outcome
Other
18-Aug-2005
Page: 270
Manufacturer
Route
Duration
PT
Suicide Attempt
11:49 AM
Report Source
Health
Professional
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Company
Representative
Dose
Product
Role
Concerta
(Methylphenidate
Hcl)
PS
Manufacturer
Route
Duration
ORAL
18 MG
1X/1DAY, ORAL
Date:07/03/02ISR Number: 3944659-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE01373
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Diabetes Mellitus
Foreign
Health
Professional
Other
Ritaline
(Methylphendiate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
20 MG/DAY;
ORAL
Date:07/03/02ISR Number: 3944785-7Report Type:Expedited (15-DaCompany Report #200216620US
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
30 MG BID PO
PT
Report Source
Product
Role
Condition Aggravated
Drug Interaction
Dysphoria
Health
Professional
Fexofenadine
Hydrochloride
(Allegra)
4
Route
PS
ORAL
Methylphenidate
Hydrochloride
Capsules
SS
ORAL
DAY
Major Depression
Suicide Attempt
20 MG QAM PO
Manufacturer
Duration
10
MON
Clavulanate
Potassium
Amoxicillin
Trihydrate
(Augmentin)
C
C
Date:07/03/02ISR Number: 3944907-8Report Type:Expedited (15-DaCompany Report #US009560
Age:12 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization 2 MG QD ORAL
Initial or Prolonged
4 MG TID ORAL
PT
Report Source
Product
Role
Manufacturer
Route
Convulsion
Health
Gabitril
PS
ORAL
Status Epilepticus
Professional
Gabitril
SS
ORAL
Company
Gabitril
SS
ORAL
Gabitril
SS
ORAL
Concerta
SS
ORAL
Concerta
SS
ORAL
Concerta
SS
ORAL
Concerta
SS
Zarontin
C
12 MG TID
Representative
ORAL
12 MG QID
ORAL
36 MG QAM
ORAL
18 MG QHS
ORAL
18 MG BID
ORAL
32 MG DAILY
18-Aug-2005
Page: 271
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/05/02ISR Number: 3946648-XReport Type:Expedited (15-DaCompany Report #13774
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Epistaxis
Foreign
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Manufacturer
Route
Duration
ORAL
18MG 1X/1DAY,
ORAL
Date:07/09/02ISR Number: 3945650-1Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 171855
Report Source
Product
Role
Ritalin Sr 20mg Generic
PS
Manufacturer
Route
Duration
Headache
Pharmaceutical Product
ORAL
40MG PO QAM
Complaint
Date:07/09/02ISR Number: 3947254-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE02251
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
ORAL
PT
Report Source
Product
Role
Acute Abdomen
Constipation
Flatulence
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
Other
Date:07/09/02ISR Number: 3947317-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE02147
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Anaemia
Contusion
Haematoma
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
Role
Manufacturer
Route
Leukopenia
Other
Tablet
PS
ORAL
7.5MG/DAY,
Myelodysplastic Syndrome
ORAL
Thrombocytopenia
Date:07/11/02ISR Number: 3948183-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE02271
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Chest Discomfort
Dyspnoea Exertional
Electrocardiogram St
Segment Depression
Foreign
Health
Professional
Other
Ritalin
(Methylphenidate
Hydrochloride)Tablet
, 10mg
PS
10 MG, QD,
Electrocardiogram T Wave
ORAL
Biphasic
Date:07/11/02ISR Number: 3948974-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE01637
Age:12 YR
Gender:Male
I/FU:F
Outcome
Hospitalization Initial or Prolonged
Other
18-Aug-2005
Page: 272
Manufacturer
Route
Duration
11:49 AM
PT
Arthropathy
Blood Creatine
Phosphokinase Increased
Blood Immunoglobulin E
Increased
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Blood Lactate
Dehydrogenase Increased
Dermatomyositis
Report Source
Product
Role
Electrophoresis Protein
Abnormal
Erythema
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Infection
Other
Manufacturer
Route
Duration
ORAL
15MG/DAY,
ORAL
Influenza Like Illness
Muscular Weakness
Pruritus
Red Blood Cell
Sedimentation Rate
Increased
Skin Disorder
Date:07/15/02ISR Number: 3948475-6Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
20 G TID
PT
Company Report #CTU 172279
Report Source
Product
Role
Ritalin Sr
PS
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
Pharmaceutical Product
Complaint
Date:07/15/02ISR Number: 3949749-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02090
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Deafness Neurosensory
Foreign
Health
Professional
Other
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Risperdal
(Risperidone)
SS
Duration
25 MG, TID
0.5 MG, QID,
ORAL
ORAL
Date:07/16/02ISR Number: 3949384-9Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 172423
Report Source
Product
Role
Concerta 54 Mg + 18
Mg
PS
Manufacturer
Route
Duration
Drug Effect Decreased
Pharmaceutical Product
ORAL
72 MG PO QD
Complaint
Date:07/16/02ISR Number: 3949755-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE01391
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
5 MG/DAY,
ORAL
18-Aug-2005
Page: 273
11:49 AM
PT
Report Source
Product
Role
Concussion
Fall
Tinnitus
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/16/02ISR Number: 3950092-9Report Type:Expedited (15-DaCompany Report #13833
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Arteriovenous
Malformation
Cerebrovascular Accident
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Manufacturer
Route
ORAL
36MG 1X/1DAY,
ORAL
Date:07/19/02ISR Number: 3950953-0Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Product
Role
Metadate Cd
(Methylphenidate
Hcl, Usp)
Extended-Release
Capsules 20 Mg
PS
Manufacturer
Route
Manufacturer
Route
Duration
Medication Error
Date:07/19/02ISR Number: 3951513-8Report Type:Expedited (15-DaCompany Report #PHBS2002AU08184
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Dysarthria
Dysphonia
Dyspnoea
Dystonia
Foreign
Literature
Health
Professional
Methylphenidate
(Methylphenidate
Hydrochloride)
Unknown
PS
Extrapyramidal Disorder
Joint Stiffness
Other
Risperidone
(Risperidone)
SS
Sertraline
(Sertraline)
SS
Morphine (Morphine)
SS
Ketorolac
(Ketorolac)
SS
10 MG/DAY,
1 MG, BID,
Movement Disorder
Muscle Twitching
25 MG/DAY,
INTRAVENOUS
INTRAVENOUS
Tropisetron
(Tropisetron
Hydrochloride)
Unknown
SS
Date:07/25/02ISR Number: 3953275-7Report Type:Expedited (15-DaCompany Report #WAES 0207SWE00008
Age:76 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
36
PT
Liver Disorder
Report Source
Product
Role
Manufacturer
Route
Zocor
Enalapril Maleate
Methylphenidate
Clindamycin
Hydrochloride
PS
SS
SS
Merck & Co., Inc
ORAL
ORAL
Bisacodyl
Metformin
Hydrochloride
Furosemide Sodium
Metoprolol Tartrate
Aspirin
Isosorbide
Mononitrate
C
SS
DAY
18-Aug-2005
Page: 274
11:49 AM
C
C
C
C
C
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/25/02ISR Number: 3953899-7Report Type:Expedited (15-DaCompany Report #CEL-2002-00577-SLO(0)
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
54 MG (54 MG,
PT
Report Source
Product
Role
Grand Mal Convulsion
Vomiting
Foreign
Health
Methylphenidate
(Brand Unspecified)
PS
Manufacturer
Route
ORAL
Professional
DAILY) PO
Fluoxetine
(Fluoxetine)
Lactulose
(Lactulose)
C
C
Date:07/25/02ISR Number: 3953968-1Report Type:Expedited (15-DaCompany Report #13754
Age:8 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Suicide Attempt
Health
Professional
Company
Concerta
(Methylphenidate
Hcl)
PS
Manufacturer
Route
Duration
ORAL
18MG 1X/1DAY,
Representative
ORAL
Date:07/25/02ISR Number: 3954094-8Report Type:Expedited (15-DaCompany Report #CEL-2002-00571-ROC(0)
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
20 MG, (20
MG, QD), PO
PT
Report Source
Product
Role
Abnormal Behaviour
Hallucination
Thrombocytopenic Purpura
Health
Professional
Company
Representative
Metadate Cd Capsule
20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
Date:07/26/02ISR Number: 3956673-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE02392
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Cerebral Perfusion
Pressure Decreased
Nuclear Magnetic
Resonance Imaging Brain
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
ORAL
Abnormal
Paraesthesia
Date:07/29/02ISR Number: 3956344-0Report Type:Expedited (15-DaCompany Report #PHBS2002DK01472
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
30 MG/DAY,
ORAL
18-Aug-2005
Page: 275
11:49 AM
PT
Report Source
Product
Role
Colitis Ulcerative
Diarrhoea
Foreign
Health
Professional
Other
Ritaline
(Methylphenidat
Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/31/02ISR Number: 3956299-9Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #CTU 173263
Report Source
Product
Role
Metadate Cd
(Methylphenidate
Hcl, Usp)
Extended-Release
Capsules
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
Medication Error
Date:08/01/02ISR Number: 3957547-1Report Type:Expedited (15-DaCompany Report #PHFR2002GB02307
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Chest Pain
Foreign
Health
Professional
Other
Ritaline
(Methylphenidat
Hydrochloride)
Tablet
PS
Duration
Date:08/02/02ISR Number: 3959865-XReport Type:Periodic
Age:18 YR
Gender:
I/FU:I
Outcome
Dose
Death
Company Report #2001AP05245
PT
Report Source
Product
Role
Completed Suicide
Literature
Health
Professional
Amitriptylline
Hydroxyzine
Methylphenidate
PS
SS
SS
Duration
Date:08/06/02ISR Number: 3959112-9Report Type:Expedited (15-DaCompany Report #FLUV00301003977
Age:30 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Death
Life-Threatening
PT
Report Source
Product
Role
Accidental Overdose
Alanine Aminotransferase
Increased
Foreign
Health
Professional
Luvox 25
(Fluvoxamine
Maleate)
PS
Aspartate
Other
50 MG DAILY
PO
ORAL
Aminotransferase
Increased
Toledomin
(Milnacipran)
SS
ORAL
Amoxan (Amoxapine)
SS
ORAL
Paxil (Paroxetine
Hydrochloride)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
Rize (Clotiazepam)
Solanax (Alprazolam)
C
C
150 MG DAILY
Blood Lactate
PO
Dehydrogenase Increased
300 MG DAILY
Blood Pressure Increased
PO
Depressed Level Of
Consciousness
10 MG DAILY
Drug Toxicity
PO
Grand Mal Convulsion
Haemodialysis
Haemorrhagic Cerebral
10 MG DAILY
Infarction
PO
Neuroleptic Malignant
Syndrome
Pyrexia
Renal Disorder
Renal Failure Acute
18-Aug-2005
Page: 276
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/07/02ISR Number: 3959526-7Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
20 MG PO TID
PT
Company Report #CTU 173699
Report Source
Coordination Abnormal
Product
Role
Ritalin
PS
Manufacturer
Route
ORAL
Disturbance In Attention
Pharmaceutical Product
Complaint
Date:08/07/02ISR Number: 3959541-3Report Type:Direct
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
AS NEEDE
PT
Company Report #CTU 173708
Report Source
Product
Role
Manufacturer
Route
Methylphenidate 5mg
PS
ORAL
Methylphenidate 10mg
SS
ORAL
Duration
Abnormal Behaviour
Delinquency
SCHOOL DAYS
Theft
ORAL
AS NEEDE
SCHOOL DAYS
ORAL
Date:08/07/02ISR Number: 3960115-9Report Type:Expedited (15-DaCompany Report #US0225000
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
SEE NARRATIVE
PT
Report Source
Product
Role
Feeling Cold
Consumer
Adderall Xr
PS
Ritalin
Birth Control Pills
Wellbutrin
(Buproprion
Hydrochloride) ("Not
On Long")
Prozac (Fluoxetine
SS
C
Hypothyroidism
Memory Impairment
C
Manufacturer
Route
Hydrochloride) (Not
On Long)
Date:08/08/02ISR Number: 3959900-9Report Type:Direct
Age:20 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
C
Company Report #CTU 173809
Report Source
Product
Role
Ritalin (Generic
Given)
PS
Manufacturer
Route
Duration
Dyspepsia
Headache
ORAL
10MG 1T PO
Pharmaceutical Product
BID
Complaint
Date:08/08/02ISR Number: 3960798-3Report Type:Expedited (15-DaCompany Report #13467
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
18MG TO 36MG
1X/1DAY
18-Aug-2005
Page: 277
PT
Report Source
Product
Role
Influenza Like Illness
Pancytopenia
Health
Professional
Concerta
(Methylphenidate
Hcl)
PS
Duration
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/08/02ISR Number: 3961109-XReport Type:Expedited (15-DaCompany Report #PHNU2002DE02392
Age:
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Cerebrovascular Disorder
Nuclear Magnetic
Resonance Imaging
Abnormal
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
ORAL
Paraesthesia
Date:08/08/02ISR Number: 3961122-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE00915
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Blood Creatinine
Increased
Candidiasis
Central Nervous System
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
SEE IMAGE,
Viral Infection
ORAL
Chlamydial Infection
Drug Withdrawal Syndrome
Herpes Zoster Infection
Neurological
Hypertension
Hypoaesthesia
Multiple Sclerosis
Nervous System Disorder
Nuclear Magnetic
Resonance Imaging Brain
Abnormal
Paraesthesia
White Blood Cell Count
Increased
Date:08/08/02ISR Number: 3961323-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE02597
Age:11 YR
Gender:Male
I/FU:I
Manufacturer
Route
ORAL
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
ORAL
PT
Report Source
Product
Role
Cold Sweat
Dizziness
Fatigue
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
Hypotension
Miosis
Neck Pain
Other
Manufacturer
Route
ORAL
Date:08/09/02ISR Number: 3962437-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE02251
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
10MG/DAY,
ORAL
18-Aug-2005
Page: 278
11:49 AM
PT
Report Source
Product
Role
Acute Abdomen
Constipation
Flatulence
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/09/02ISR Number: 3962441-6Report Type:Expedited (15-DaCompany Report #PHFR2002IE02406
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Diabetes Mellitus
Inadequate Control
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
5 MG, QD,
ORAL
Date:08/09/02ISR Number: 3993984-7Report Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #PHEH2002US05111
PT
Report Source
Product
Role
Manufacturer
Route
Attention
Deficit/Hyperactivity
Disorder
Health
Professional
Company
Trileptal
(Oxcarbazepine)
Tablet
PS
ORAL
Concomitant Disease
Representative
Concerta
(Methylphenidate
Hydrochloride)
SS
ORAL
Duration
900 MG/DAY,
ORAL
Aggravated
Drug Interaction
Inhibition
54 MG/DAY,
ORAL
Date:08/14/02ISR Number: 3962127-8Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #CTU 174166
Report Source
Product
Role
Manufacturer
Route
Methylphenidate
Mallinckrodt
PS
Mallinckrodt
ORAL
Duration
Drug Ineffective
Pharmaceutical Product
10MG PO BID
Complaint
Date:08/14/02ISR Number: 3962133-3Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
1 1/2 AM PO 1
PT
Company Report #CTU 174167
Report Source
Drug Ineffective
Product
Role
Ritalin 10mg
PS
Manufacturer
Route
ORAL
Pharmaceutical Product
NOON PO
7
YR
Complaint
Date:08/15/02ISR Number: 3963676-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE02713
Age:31 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Coronary Artery Occlusion
Myocardial Infarction
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
7.5 MG/DAY;
ORAL
Date:08/15/02ISR Number: 3963711-8Report Type:Expedited (15-DaCompany Report #PHNU2002DE00915
Age:14 YR
Gender:Male
I/FU:F
Outcome
Hospitalization Initial or Prolonged
Other
18-Aug-2005
Page: 279
11:49 AM
PT
Antibody Test Abnormal
Blood Creatinine
Increased
Central Nervous System
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Viral Infection
Drug Withdrawal Syndrome
Flushing
Hypertension
Report Source
Product
Role
Hypoaesthesia
Multiple Sclerosis
Nervous System Disorder
Nuclear Magnetic
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
UNK, UNK,
Resonance Imaging Brain
ORAL;
Abnormal
60MG/DAY
Paraesthesia
Date:08/15/02ISR Number: 3963712-XReport Type:Expedited (15-DaCompany Report #PHNU2002DE02597
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Manufacturer
Route
Cold Sweat
Dizziness
Fatigue
Hypotension
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
ORAL
Pipamperone(Pipamper
one) Unknown
SS
ORAL
UNK, UNK,
Miosis
ORAL
Neck Pain
Urine Analysis Abnormal
UNK, UNK,
ORAL
Date:08/15/02ISR Number: 3964053-7Report Type:Expedited (15-DaCompany Report #14192
Age:40 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
36MG 1X/1
PT
Report Source
Product
Role
Appendicitis
Volvulus Of Bowel
Health
Professional
Concerta
(Methylphenidate
Hci)
PS
Manufacturer
Route
ORAL
DAY, ORAL
2
WK
Date:08/15/02ISR Number: 3964124-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02307
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Creatine
Phosphokinase Increased
Chest Pain
Electrocardiogram
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Clonidine
(Clonidine)
C
SEE IMAGE
Repolarisation
Abnormality
Electrocardiogram St
Segment Elevation
Palpitations
Date:08/15/02ISR Number: 3964125-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE01637
Age:12 YR
Gender:Male
I/FU:F
Outcome
Hospitalization Initial or Prolonged
Other
18-Aug-2005
Page: 280
Manufacturer
Route
Duration
11:49 AM
PT
Angiotensin Converting
Enzyme Increased
Autoimmune Disorder
Blood Parathyroid Hormone
Decreased
Cardiomegaly
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Dermatomyositis
Glomerular Vascular
Disorder
Report Source
Product
Role
Hepatomegaly
Influenza Like Illness
Livedo Reticularis
Lymphadenopathy
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
15MG/DAY,
Pruritus
ORAL
Serum Ferritin Increased
Date:08/16/02ISR Number: 3962951-1Report Type:Direct
Age:39 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 174334
Report Source
Product
Role
Methylphenidate
(Ritalin) 10 Mg Qd X
2 Wks And Then 10mg
Bid
PS
Manufacturer
Route
Manufacturer
Route
Duration
Headache
Nausea
10 MG QD X 2
WKS AND THEN
10MG BID
Date:08/19/02ISR Number: 3964780-1Report Type:Expedited (15-DaCompany Report #PHBS2002BR09348
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hypertrichosis
Penis Disorder
Foreign
Health
Professional
Ritalina(Methylpheni
date Hydrochloride)
Unknown
PS
Duration
10 MG/DAY,
Other
ORAL
ORAL
Date:08/20/02ISR Number: 3964270-6Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
1.5 TABS
PT
Company Report #CTU 174577
Report Source
Product
Role
Methylphenidate 10mg
PS
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
AM
Pharmaceutical Product
AND NOON
Complaint
Date:08/20/02ISR Number: 3965811-5Report Type:Expedited (15-DaCompany Report #PHBS2002JP08682
Age:74 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Anorexia
Depression
Diarrhoea
Foreign
Literature
Health
Parlodel
(Bromocriptine
Mesilate)
PS
ORAL
Disease Progression
Professional
Dizziness
Drug Effect Decreased
Dysuria
Extrapyramidal Disorder
Other
Ludiomil Tablet
(Maprotiline
Hydrochloridle)
Tablet
SS
ORAL
Methylphenidate
Hydrochloride
(Methylphenidate
Hydrochloride)
SS
ORAL
Duration
5 MG/DAY,
ORAL
10 UG/DAY,
Gait Disturbance
ORAL
Irritability
Nausea
Somnolence
10 MG/DAY,
ORAL
Sulpiride
18-Aug-2005
Page: 281
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
(Sulpiride)
Trazodone
(Trazodone)
Lithium Carbonate
Mianserin
(Mianserin)
Pergolide
(Pergolide)
Levothyrox
C
C
C
C
C
C
Date:08/21/02ISR Number: 3965784-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02520
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Disability
Other
60 MG MANE +
PT
Report Source
Product
Role
Manufacturer
Route
Dystonia
Emotional Distress
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
ORAL
Risperidone
(Risperidone)
SS
ORAL
30 MG TID,
ORAL
0.5 G MANE,
ORAL
Date:08/21/02ISR Number: 3966622-7Report Type:Expedited (15-DaCompany Report #CEL-2002-00967-SLO(0)
Age:24 YR
Gender:Male
I/FU:U
Outcome
Dose
Other
PT
Report Source
Product
Role
Alanine Aminotransferase
Increased
Aspartate
Foreign
Health
Professional
Equasym 5mg
(Methylphenidate
Hydrochloride)
PS
Neurontin
(Gabapentin)
C
Manufacturer
Route
Duration
SEE IMAGE
Aminotransferase
Increased
Haematocrit Decreased
Haemoglobin Decreased
Thrombocytopenia
ORAL
Date:08/26/02ISR Number: 3966953-0Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 175042
Report Source
Product
Role
Ritalin
PS
Manufacturer
Route
Duration
Antiphospholipid
ORAL
15 MG PO BID
Antibodies Positive
Coagulopathy
Date:08/26/02ISR Number: 3966954-2Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
10 MG PO BID
PT
Antiphospholipid
Antibodies Positive
Coagulopathy
18-Aug-2005
Page: 282
11:49 AM
Company Report #CTU 175043
Report Source
Product
Role
Ritalin
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/26/02ISR Number: 3966955-4Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
15 MG PO BID
PT
Company Report #CTU 175044
Report Source
Antiphospholipid
Product
Role
Ritalin
PS
Manufacturer
Route
ORAL
Antibodies Positive
Coagulopathy
Date:08/26/02ISR Number: 3967035-4Report Type:Direct
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
10 MG PO BID
PT
Company Report #CTU 175041
Report Source
Antinuclear Antibody
Product
Role
Ritalin
PS
Manufacturer
Route
ORAL
Positive
Antiphospholipid
Antibodies Positive
Date:08/26/02ISR Number: 3967037-8Report Type:Direct
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
30 MG PO
PT
Company Report #CTU 175040
Report Source
Product
Role
Ritalin
PS
Manufacturer
Route
Duration
Coagulopathy
ORAL
DAILY DIVIDED
DOSES
Date:08/26/02ISR Number: 3967121-9Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
20MG BID
PT
Company Report #CTU 175066
Report Source
Product
Role
Generic Ritalin 20
Bid
PS
Duration
Dyspepsia
Pharmaceutical Product
Manufacturer
Route
Complaint
Vomiting
Date:08/27/02ISR Number: 3968304-4Report Type:Expedited (15-DaCompany Report #CEL-2002-00991-SLO (0)
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Aggression
Formication
Foreign
Health
Methylphenidate
(Brand Unspecified)
PS
Hallucination
Professional
Manufacturer
Route
Duration
ORAL
18 MG (18 MG,
UNKNOWN), PO
Tic
Date:08/28/02ISR Number: 3968199-9Report Type:Direct
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 283
PT
Company Report #CTU 175257
Report Source
Product
Role
Ritalin (Generic)
PS
Duration
Agitation
Headache
Pharmaceutical Product
Complaint
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/28/02ISR Number: 3968200-2Report Type:Direct
Age:40 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 175258
Report Source
Agitation
Headache
Pharmaceutical Product
Complaint
Date:09/04/02ISR Number: 3970837-1Report Type:Direct
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Role
Ritalin (Generic)
PS
Manufacturer
Route
PT
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Company Report #CTU 175664
Report Source
Product
Role
Ritalin (Generic)
PS
Duration
Agitation
Headache
Pharmaceutical Product
Complaint
Date:09/04/02ISR Number: 3970838-3Report Type:Direct
Age:40 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Product
Duration
PT
Company Report #CTU 175666
Report Source
Product
Role
Ritalin (Generic)
PS
Duration
Agitation
Headache
Pharmaceutical Product
Complaint
Date:09/05/02ISR Number: 3973029-5Report Type:Expedited (15-DaCompany Report #PHBS2002BE09839
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Congenital Anomaly
Papilloedema
Foreign
Health
Professional
Ritaline(Methylpheni
dat Hydrochloride)
Unknown
PS
Duration
10 MG, BID,
Other
ORAL
ORAL
Date:09/06/02ISR Number: 3972444-3Report Type:Direct
Age:9 YR
Gender:
I/FU:I
Outcome
Dose
Other
PT
18-Aug-2005
Page: 284
Report Source
Product
Role
Manufacturer
Metadate Er
PS
Metadate Cd
SS
Medeva
Pharmaceuticals
Medeva
Pharmaceuticals
Route
Duration
Medication Error
Date:09/06/02ISR Number: 3972519-9Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #USP 54964
PT
Company Report #USP 55033
Report Source
Product
Role
Manufacturer
Metadate Cd
PS
Metadate Er
SS
Celltech
Pharmaceuticals
Celltech
Pharmaceuticals
Duration
Medication Error
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/06/02ISR Number: 4008042-5Report Type:Periodic
Age:21 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Convulsion
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hcl)
Prozac
PS
C
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
Date:09/06/02ISR Number: 4008060-7Report Type:Periodic
Age:7 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
Company Report #13130
Company Report #13605
PT
Report Source
Product
Role
Growth Retardation
Weight Decreased
Consumer
Concerta
(Methylphenidate
Hcl)
PS
Duration
72 MG(4-18MG
TABS) 1X/1DAY
Date:09/06/02ISR Number: 4008064-4Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #13714
PT
Report Source
Product
Role
Anxiety
Delusion
Hallucination
Consumer
Concerta
(Methylphenidate
Hcl)
PS
Risperdal
C
Duration
18MG ( 1 IN
Neurosis
AM-1 @LUNCH)
Date:09/06/02ISR Number: 4008066-8Report Type:Periodic
Age:6 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
Company Report #13787
PT
Report Source
Product
Abnormal Dreams
Consumer
Concerta
Duration
Role
Growth Retardation
Muscle Twitching
(Methylphenidate
Hcl)
PS
ORAL
36 MG
1X/1DAY, ORAL
Date:09/09/02ISR Number: 3973215-4Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 175898
Report Source
Product
Role
Generic Ritalin
PS
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
Pharmaceutical Product
Complaint
Date:09/09/02ISR Number: 3974009-6Report Type:Expedited (15-DaCompany Report #PHBS2002CA10340
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Cataract
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Risperdal
(Risperidone)
C
Duration
ORAL
18-Aug-2005
Page: 285
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/09/02ISR Number: 3974027-8Report Type:Expedited (15-DaCompany Report #ALZ-14192
Age:40 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Appendicitis
Volvulus Of Bowel
Health
Professional
Concerta
(Methylphenidate
Hcl) (Unspecified)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
36 MG, 1 IN 1
DAY (S), ORAL
Date:09/09/02ISR Number: 3974504-XReport Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #CTU 175997
Report Source
Product
Role
Metadate Er Tablets
(Methylphenidate
Hydrochloride
Extended-Release
Tablets, Usp)20mg
PS
Manufacturer
Route
Manufacturer
Route
Duration
Medication Error
Date:09/11/02ISR Number: 3974530-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE03005
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Accident
Angina Pectoris
Blood Creatine
Phosphokinase Increased
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
12.5 MG/DAY,
Blood Creatine
ORAL
Phosphokinase Mb
Increased
Electrocardiogram St
Segment Elevation
Heart Injury
Sinus Arrhythmia
ORAL
Date:09/12/02ISR Number: 3975236-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE03018
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Diabetes Mellitus
Foreign
Health
Professional
Other
Ritalin-Sr
(Methlphenidate
Hydrochloride)
Tablet
PS
ORAL
Medikinet
(Methylphenidate
Hydrochloride)
SS
ORAL
Duration
ORAL
ORAL
Date:09/12/02ISR Number: 3975569-1Report Type:Expedited (15-DaCompany Report #PHEH2002US07830
Age:
Gender:Female
I/FU:I
Outcome
Dose
Death
20 UNK, QD,
18-Aug-2005
Page: 286
PT
Report Source
Product
Role
Completed Suicide
Health
Professional
Ritalin La
(Methylphenid
Hydrochloride)
Extended Release
Capsules
PS
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
ORAL
Date:09/13/02ISR Number: 3975684-2Report Type:Direct
Age:39 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 176334
Report Source
Product
Role
Methylphenidate
(Ritalin)10mg Qd X
2wk And Then 10mg
Bid
PS
Amphetamine Salts
20mg
SS
Adderall
C
Manufacturer
Route
Duration
Headache
Muscle Spasms
Muscle Twitching
Nausea
10MG PO QD X
Visual Disturbance
2WK AND THEN
10MG BID
ORAL
20MG 1 TAB
QID PO
Date:09/13/02ISR Number: 3975833-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE03023
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Fibrinogen
Decreased
Coagulation Factor
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Decreased
Other
Manufacturer
Route
Duration
20 MG/DAY,
ORAL
Coagulation Time
Prolonged
Prothrombin Time
Shortened
Date:09/13/02ISR Number: 3975839-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE03067
Age:
Gender:Male
I/FU:I
ORAL
Outcome
Dose
Other
PT
Report Source
Product
Role
Haematoma
Weight Decreased
Foreign
Health
Professional
Other
Ritalin
(Methylphenidate
Hydrochloride)
Tablet, 10 Mg
PS
Manufacturer
Route
Duration
ORAL
5 MG, BID,
ORAL
Date:09/13/02ISR Number: 3976076-2Report Type:Expedited (15-DaCompany Report #PHEH2002US07830
Age:
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Completed Suicide
Health
Professional
Ritalin La
(Methylphenidate
Hydrochloride)
Extended Release
Capsules
PS
20 UNK, QD,
ORAL
Date:09/16/02ISR Number: 3976553-4Report Type:Expedited (15-DaCompany Report #NSADSS2002030267
Age:9 YR
Gender:Female
I/FU:I
Outcome
Death
Hospitalization 18-Aug-2005
Page: 287
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Initial or Prolonged
Dose
PT
Report Source
Product
Role
Blood Glucose Increased
Cardio-Respiratory Arrest
Cough
Ear Operation
Influenza Like Illness
Health
Professional
Concerta (18 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
Respiratory Disorder
DAY(S), ORAL
Vomiting
Ceftin (Cefuroxime
Axetil)
Rocephin
(Ceftriaxone Sodium)
Albuterol
(Salbutamol)
Date:09/16/02ISR Number: 3977002-2Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
C
C
C
Company Report #CTU 176485
Report Source
Product
Role
Manufacturer
Route
Methylphenidate
Sr-Concerta-18mg
PS
Concerta
ORAL
Manufacturer
Route
Duration
Chest Pain
Muscle Twitching
18MG QD ORAL
Date:09/17/02ISR Number: 3976701-6Report Type:Expedited (15-DaCompany Report #FLUV00302002273
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Complications Of Maternal
Exposure To Therapeutic
Drugs
Foreign
Health
Professional
Depromel 25
(Fluvoxamine
Maleate)
PS
Condition Aggravated
Drug Withdrawal Syndrome
Other
Meilax (Ethyl
Loflazepate)
SS
Duration
DAILY BF
DAILY BF
Hypertonia Neonatal
Maternal Drugs Affecting
Anafranil
(Clomipramine
Foetus
Hydrochloride)
SS
Mental Disorder
Amoxan (Amoxapine)
SS
Somnolence Neonatal
Tremor Neonatal
Impromen
(Bromperidol)
SS
Ritalin
(Methylphenidate
Hydrochloride)
SS
DAILY BF
DAILY BF
ORAL
SEE IMAGE
DAILY BF
Date:09/17/02ISR Number: 3976805-8Report Type:Expedited (15-DaCompany Report #PHBS2002JP10841
Age:22 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Dystonia
Muscle Contractions
Involuntary
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Unknown
PS
Trismus
Other
Miradol (Sulpiride)
Depas (Etizolam)
C
C
SEE IMAGE
18-Aug-2005
Page: 288
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/18/02ISR Number: 3978783-4Report Type:Expedited (15-DaCompany Report #NSADSS2002031832
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Grand Mal Convulsion
Loss Of Consciousness
Consumer
Concerta ( 18 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
18 MG, 1 IN 1
DAY(S), ORAL
Date:09/18/02ISR Number: 3978804-9Report Type:Expedited (15-DaCompany Report #CEL-2002-00263-ROC(0)
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
Required
20 MG (2DMG,
Intervention to
OD), PO; SEE
Prevent Permanent
IMAGE
Impairment/Damage
PT
Report Source
Product
Role
Manufacturer
Route
Dialysis
Nephrotic Syndrome
Renal Failure Chronic
Consumer
Health
Professional
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
ORAL
Metadate Er Tablets
20mg
(Methylphenidate
Hydrochloride)
SS
ORAL
Singulair
C
20 MG (20 MG,
QAM), PO
Date:09/19/02ISR Number: 3978460-XReport Type:Expedited (15-DaCompany Report #A0379987A
Age:35 YR
Gender:
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Completed Suicide
Literature
Wellbutrin Sr
Duration
Role
Manufacturer
Route
Intentional Misuse
Health
Professional
Tablet-Controlled
Release (Bupropion
Hydrochloride)
PS
ORAL
ORAL
Venlafaxine
Hydrochloride
(Formulation
Unknown)
(Venlafaxine
Methylphenidate
(Formulation
Unknown)
(Methylphenidate)
Date:09/20/02ISR Number: 3978632-4Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
SS
Company Report #CTU 176901
Report Source
Product
Role
Manufacturer
Route
Ritalin Hcl 5mg
Novartis
PS
Novartis
ORAL
Duration
Drug Ineffective
Pharmaceutical Product
5MG 1 1/2 PO
Complaint
Q AM AND NOON
18-Aug-2005
Page: 289
SS
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/23/02ISR Number: 3981279-7Report Type:Direct
Age:30 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 177036
Report Source
Product
Role
Adderall
Ritalin
Gen Dexadrine
PS
SS
SS
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
Pharmaceutical Product
Complaint
Date:09/24/02ISR Number: 3981046-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE03133
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Aggression
Foreign
Consumer
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Duration
ORAL
ORAL
Date:09/24/02ISR Number: 3981318-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE03132
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Electrocardiogram
Abnormal
Electrocardiogram Qt
Corrected Interval
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
20MG/DAY,
Prolonged
ORAL
Hyperhidrosis
Loss Of Consciousness
Somnolence
Ventricular Extrasystoles
Date:09/24/02ISR Number: 3981839-3Report Type:Expedited (15-DaCompany Report #NSADSS2002030267
Age:9 YR
Gender:Female
I/FU:I
Manufacturer
Route
ORAL
Outcome
Dose
Duration
Death
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Blood Glucose Increased
Cardio-Respiratory Arrest
Cough
Drug Level Increased
Influenza Like Illness
Health
Professional
Concerta (18 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
18 MG, 1 IN 1
DAY(S), ORAL
Ceftin (Cefuroxime
Axetil)
Rocephin
(Ceftriaxone Sodium)
Albuterol
(Salbutamol)
Date:09/25/02ISR Number: 3981379-1Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
C
C
Company Report #CTU 177222
Report Source
Product
Role
Mallinckrodt
(Methylin 10 Mg
9/25/02 )
PS
Manufacturer
Route
Duration
Drug Ineffective
Pharmaceutical Product
Complaint
10MG PO BID
18-Aug-2005
Page: 290
C
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/25/02ISR Number: 3982315-4Report Type:Expedited (15-DaCompany Report #CEL-2002-00263-ROC (1)
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
Required
20 MG (20 MG,
Intervention to
QD), PO
Prevent Permanent
Impairment/Damage
PT
Report Source
Product
Role
Manufacturer
Route
Dialysis
Nephrotic Syndrome
Renal Failure Chronic
Consumer
Health
Professional
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
ORAL
Metadate Er Tablets
20mg (Methyphenidate
Hydrochloride)
SS
ORAL
20 MG (20 MG,
QAM), PO
Albuterol
(Salbutamol)
Singulair
Aerobid
(Flunisolide)
Zyrtec (Cetirizine
Hydrochloride)
SS
C
C
C
Date:09/27/02ISR Number: 3982877-7Report Type:Expedited (15-DaCompany Report #NSADSS2002032843
Age:42 YR
Gender:
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Completed Suicide
Toxicologic Test Abnormal
Literature
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylpehenidate
Hydrochloride)
Bupropion(Amfebutamo
ne)
Role
Manufacturer
Route
Manufacturer
Route
Duration
PS
SS
Date:09/27/02ISR Number: 3982889-3Report Type:Expedited (15-DaCompany Report #NSADSS2002032842
Age:42 YR
Gender:
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Death
Death
Literature
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
Bupropion
PS
SS
Date:09/27/02ISR Number: 3982891-1Report Type:Expedited (15-DaCompany Report #NSADSS2002032841
Age:41 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Death
Hospitalization Initial or Prolonged
Required
Intervention to
Prevent Permanent
Impairment/Damage
18-Aug-2005
Page: 291
11:49 AM
PT
Report Source
Product
Agitation
Coma
Pulmonary Oedema
Respiratory Arrest
Somnolence
Stupor
Literature
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
Methadone
(Methadone)
Crack Cocaine
(Cocaine)
Role
PS
SS
SS
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/27/02ISR Number: 3984220-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE03165
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
ORAL
PT
Report Source
Product
Role
Diabetes Mellitus
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
ORAL
Other
Ritalin-Sr
(Methylphenidate
Hydrochloride) Slow
Release Tablet
SS
ORAL
Manufacturer
Route
40MG/DAY,
ORAL
Date:09/27/02ISR Number: 3984262-0Report Type:Expedited (15-DaCompany Report #PHBS2002BR09348
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Growth Accelerated
Hair Growth Abnormal
Penis Disorder
Precocious Puberty
Foreign
Health
Professional
Other
Ritalin
(Methylphenidate
Hydrochloride)
Unknown
PS
Manufacturer
Route
Duration
ORAL
10 MG/DAY,
ORAL
Date:10/02/02ISR Number: 3986870-XReport Type:Expedited (15-DaCompany Report #NSADSS2002030267
Age:9 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Death
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Acute Sinusitis
Alanine Aminotransferase
Increased
Aspartate
Aminotransferase
Health
Professional
Concerta (18 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
18 MG, 1 IN 1
Increased
DAY(S), ORAL
Manufacturer
Route
ORAL
Blood Glucose Increased
Cardio-Respiratory Arrest
Influenza Like Illness
Respiratory Disorder
Vomiting
Ceftin (Cefuroxime
Axetil)
Rocephin
(Ceftriaxone Sodium)
Albuterol
(Salbutamol)
Claritin
(Loratadine)
Flovent (Fluticasone
Propionate)
C
C
C
C
C
Date:10/02/02ISR Number: 3986873-5Report Type:Expedited (15-DaCompany Report #NSADSS2002033023
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
ORAL
18-Aug-2005
Page: 292
11:49 AM
PT
Report Source
Product
Role
Dystonia
Health
Professional
Company
Representative
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/03/02ISR Number: 3986336-7Report Type:Expedited (15-DaCompany Report #NSADSS2002031834
Age:6 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abnormal Behaviour
Aggression
Kidney Infection
Consumer
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
DAY (S), ORAL
Date:10/03/02ISR Number: 3988011-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE01782
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
ORAL
PT
Report Source
Product
Role
Arrhythmia
Blood Pressure Increased
Bundle Branch Block Right
Foreign
Health
Professional
Ritaline(Methylpheni
date
Hydrochloride)Tablet
PS
Cardiac Murmur
Electrocardiogram
Abnormal
Fatigue
Heart Sounds Abnormal
Pulmonary Hypertension
Pulmonary Valve
Incompetence
Tricuspid Valve
Incompetence
Ventricular Hypertrophy
Other
Manufacturer
Route
ORAL
Date:10/03/02ISR Number: 3988013-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE03133
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
20 MG, BID,
PT
Report Source
Product
Role
Aggression
Anorexia
Foreign
Consumer
Other
Ritaline(Methylpheni
date
Hydrochloride)Tablet
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:10/04/02ISR Number: 3985759-XReport Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Company Report #CTU 177953
Report Source
Nausea
Pharmaceutical Product
Complaint
Vomiting
Product
Role
Ritalin
PS
Manufacturer
Route
Manufacturer
Route
Date:10/04/02ISR Number: 3988233-XReport Type:Expedited (15-DaCompany Report #CEL-2002-01062-ROC (0)
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Chest Pain
Headache
Hypertension
Nausea
Health
Professional
Metadate Er Tablets
20mg
(Methylphenidate
Hydrochloride)
PS
Duration
40MG QAM,
Ventricular Extrasystoles
20MG Q NOON,
Vomiting
PO; 20MG QAM,
20MG Q NOON,
PO
18-Aug-2005
Page: 293
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Clonidine
(Clonidine)
SS
ORAL
0.2 MG (0.2
MG, QHS),
PO;. 0.5 MG
(0.05 MG,QHS)
PO
Date:10/04/02ISR Number: 3988234-1Report Type:Expedited (15-DaCompany Report #CEL-2002-00571-ROC (1)
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abnormal Behaviour
Hallucination
Medication Error
Thrombocytopenic Purpura
Health
Professional
Company
Representative
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
20 MG (20 MG,
QAM), PO
Date:10/07/02ISR Number: 3984496-5Report Type:Expedited (15-DaCompany Report #WAES 0207SWE00008
Age:76 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
36
PT
Report Source
Product
Role
Manufacturer
Route
Liver Disorder
Health
Professional
Zocor
Enalapril Maleate
Methylphenidate
Clindamycin
Hydrochloride
PS
SS
SS
Merck & Co., Inc
ORAL
ORAL
Bisacodyl
Metformin
Hydrochloride
Furosemide Sodium
Metoprolol Tartrate
Aspirin
Isosorbide
C
SS
DAY
C
C
C
C
Mononitrate
C
Date:10/07/02ISR Number: 3987398-3Report Type:Expedited (15-DaCompany Report #NSADSS2002034127
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Caecitis
Health
Professional
Concerta (36 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Albuterol
(Salbutamol)
C
36 MG, 1 IN 1
DAY(S), ORAL
Date:10/07/02ISR Number: 3989871-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE03005
Age:11 YR
Gender:Male
I/FU:F
Outcome
Hospitalization Initial or Prolonged
Other
18-Aug-2005
Page: 294
11:49 AM
PT
Accident
Angina Pectoris
Blood Creatine
Phosphokinase Increased
Blood Creatine
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Phosphokinase Mb
Increased
Brain Contusion
Cardiac Disorder
Report Source
Product
Role
Cardiomyopathy
Contusion
Electrocardiogram St
Segment Elevation
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
25 MG/DAY,
Sinus Arrhythmia
ORAL
Date:10/08/02ISR Number: 3987210-2Report Type:Expedited (15-DaCompany Report #USA-2002-0001929
Age:31 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Coma
Overdose
Toxicologic Test Abnormal
Consumer
Health
Professional
Other
Oxycodone
Hydrochloride
(Similar To Nda
20-553) (Oxycodone
Hydrochloride) Cr
PS
Cocaine (Cocaine)
SS
Methylphenidate
(Methylphenidate)
Tablet
SS
Diazepam (Diazepam)
Unknown
SS
Doxepin (Doxepin)
Tablet, 50 Mg
SS
ORAL
Fluoxetine
Hydrochloride(Fluoxe
tine Hydrochloride)
Tablet
SS
ORAL
Duration
MG
MG
ORAL
10 MG, SEE
TEXT, ORAL
MG
200 MG,
NOCTE, ORAL
20 MG, DAILY,
ORAL
Date:10/08/02ISR Number: 3989913-2Report Type:Expedited (15-DaCompany Report #CEL-2002-01111-ROC(0)
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Chronic Hepatitis
Health
Professional
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Duration
Date:10/10/02ISR Number: 3991867-XReport Type:Expedited (15-DaCompany Report #NSADSS2002034861
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG, 1 IN 1
DAY(S), ORAL
18-Aug-2005
Page: 295
PT
Report Source
Product
Role
Crying
Depression
Suicidal Ideation
Consumer
Concerta (36 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/15/02ISR Number: 3993728-9Report Type:Expedited (15-DaCompany Report #PHEH2002US06619
Age:20 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Lupus-Like Syndrome
Polycythaemia
Rheumatoid Arthritis
Consumer
Ritalin
(Methylphenidate
Hydrochloride)
Tablet, 10 Mg
PS
Minocin
(Minocycline)
C
Manufacturer
Route
Duration
ORAL
10 MG, BID,
ORAL
Date:10/15/02ISR Number: 3994024-6Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG PO
10 MG
PT
Company Report #CTU 178615
Report Source
Product
Role
Agitation
Concerta
PS
Drug Ineffective
Dexedrine
SS
Manufacturer
Route
Duration
ORAL
PO
Educational Problem
DEXEDRINE
Fear
Heart Rate Increased
Panic Reaction
Date:10/15/02ISR Number: 3994093-3Report Type:Direct
Age:18 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
10 PO TID
PT
Company Report #CTU 178664
Report Source
Product
Role
Generic
Methylphenidate
PS
Manufacturer
Route
Duration
Drug Effect Decreased
Pharmaceutical Product
2
MON
Complaint
ORAL
Date:10/16/02ISR Number: 3992965-7Report Type:Direct
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 178804
Report Source
Product
Role
Generic Ritalin
(10mg)
(Methylphenidate)
PS
Manufacturer
Route
Manufacturer
Route
Duration
Depression
Excitability
Mood Swings
RITALIN 15 MG
Pharmaceutical Product
BID (0)
Complaint
Date:10/16/02ISR Number: 3993136-0Report Type:Expedited (15-DaCompany Report #PHBS2002JP10841
Age:22 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Dystonia
Hyperhidrosis
Medication Error
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
Muscle Contractions
Other
....
Miradol (Sulpiride)
Depas (Etizolam)
C
C
C
30 MG/D;
ORAL, SEE
Involuntary
IMAGE
Tetanus
Trismus
18-Aug-2005
Page: 296
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/16/02ISR Number: 3993182-7Report Type:Expedited (15-DaCompany Report #A0381652A
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Anxiety
Hallucination, Auditory
Insomnia
Medication Error
Psychotic Disorder
Literature
Consumer
Paxil (Formulation
Unknown) (Paroxetine
Hydrochloride)
Dexedrine
(Formulation
Unknown)
(Dextroamphetamine
Sulfate)
Role
Manufacturer
Route
Duration
PS
SS
ORAL
Methylphenidate Hcl
(Formulation
Unknown)
(Methylphenidate
Hcl)
SS
ORAL
ORAL
Date:10/16/02ISR Number: 3994948-XReport Type:Expedited (15-DaCompany Report #PHNU2002DE03393
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Blindness
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:10/16/02ISR Number: 3994952-1Report Type:Expedited (15-DaCompany Report #PHBS2002NO12114
Age:25 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Psychotic Disorder
Foreign
Consumer
Other
Ritaline
(Methylphenidate
Hydrochloride)
Unknown
PS
Topimax (Topiramate)
C
ORAL
Manufacturer
Route
ORAL
Oxcarbazepine
Date:10/17/02ISR Number: 3993793-9Report Type:Direct
Age:65 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Asthenia
Pain
C
Company Report #CTU 178896
Report Source
Product
Role
Manufacturer
D-Threo-Methylphenid
ate Hcl Celgene /
Biologics
PS
Celgene/Biologics
Megace
Decadron
Arimidex
C
C
C
5 MG BID
Date:10/17/02ISR Number: 3997352-3Report Type:Expedited (15-DaCompany Report #HQ4590910OCT2002
Age:
Gender:Unknown
I/FU:I
Outcome
Other
18-Aug-2005
Page: 297
PT
Drug Exposure Via Breast
Milk
Drug Withdrawal Syndrome
Neonatal
Hypertonia Neonatal
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Maternal Drugs Affecting
Foetus
Somnolence Neonatal
Dose
Report Source
Product
Role
Health
Professional
Amoxan (Amoxapine,
Capsule)
PS
Anafranil
(Clomipramine
Hydrochloride, )
SS
Amoxan (Amoxapine,
Capsule)
SS
Anafranil
(Clomipramine
Hydrochloride, )
SS
Fluvoxamine Maleate
(Fluvoxamine
Maleate, )
SS
Duration
Tremor Neonatal
TRANSPLACENTAL
DAILY,
TRANSPLANCENT
AL; GESTATION
UNTIL
DELIVERY
TRANSPLACENTAL
DAILY,
TRANSPLACENTA
L; GESTATION
UNTIL
DELIVERY
TRANSMAMMARY
DAILY,
TRANSMAMMARY
TRANSMAMMARY
DAILY,
TRANSMAMMARY
TRANSPLACENTAL
TRANSPLACENTA
L; GESTATION
DAILY,
Manufacturer
Route
UNTIL
DELIVERY
TRANSMAMMARY
Fluvoxamine Maleate
(Fluvoxamine
Maleate, )
SS
Impromen
(Bromperidol, )
SS
Impromen
(Bromperidol, )
SS
Meilax (Ethyl
Loflazepate, )
SS
Meilax (Ethyl
Loflazepate, )
SS
Ritalin
(Methylphenidate
Hydrochloride, )
SS
DAILY,
TRANSMAMMARY
TRANSPLACENTAL
DAILY,
TRANSPLACENTA
L; GESTATION
UNTIL
DELIVERY
TRANSMAMMARY
DAILY,
TRANSMAMMARY
TRANSPLACENTAL
DAILY,
TRANSPLACENTA
L; GESTATION
UNTIL
DELIVERY
TRANSMAMMARY
DAILY,
TRANSMAMMARY
TRANSPLACENTAL
TRANSPLACENTA
L; GESTATION
UNTIL
DAILY,
DELIVERY
Ritalin
(Methylphenidate
18-Aug-2005
Page: 298
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hydrochloride, )
TRANSMAMMARY
SS
DAILY,
TRANSMAMMARY
Date:10/18/02ISR Number: 3995635-4Report Type:Expedited (15-DaCompany Report #C2002-2994.01
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Chest Pain
Headache
Health
Professional
Metadate Er Tablets
20mg Celltech
PS
ORAL
Heart Rate Irregular
Hypertension
Ventricular Extrasystoles
Other
Clonidine
Hydrochloride
Tablets 0.2 Mg Mylan
SS
ORAL
Duration
SEE IMAGE
SEE IMAGE
Vomiting
Date:10/18/02ISR Number: 3996781-1Report Type:Expedited (15-DaCompany Report #PHBS2002CH12291
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Aggression
Agitation
Foreign
Health
Ritaline(Methylpheni
date Hydrochloride)
PS
Confusional State
Professional
Screaming
Other
Manufacturer
Route
Manufacturer
Route
Duration
5 TO 10
MG/DAY
Date:10/18/02ISR Number: 3998156-8Report Type:Expedited (15-DaCompany Report #PHEH2002US08968
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
20 MG,
PT
Report Source
Product
Role
Dyskinesia
Hallucination
Movement Disorder
Muscle Contractions
Involuntary
Other
Ritalin La
(Methylphenidate
Hydrochloride)
Extended Release
Capsules
PS
ORAL
Pain In Extremity
ONCE/SINGLE,
Tic
ORAL
Claritin
(Loratadine)
Antibiotics
C
C
Date:10/21/02ISR Number: 3998546-3Report Type:Expedited (15-DaCompany Report #NSADSS2002033025
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Duodenal Ulcer
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:10/22/02ISR Number: 3996066-3Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Ritalin Methylphenidate
PS
Manufacturer
Route
Duration
Drug Effect Decreased
Pharmaceutical Product
15MG BID PO
Complaint
18-Aug-2005
Page: 299
Company Report #CTU 179178
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/22/02ISR Number: 3997497-8Report Type:Expedited (15-DaCompany Report #NSADSS2002033565
Age:48 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
36 MG, 1 IN 1
PT
Report Source
Product
Role
Open Angle Glaucoma
Consumer
Concerta
PS
Manufacturer
Route
ORAL
DAY(S), ORAL
Amoxicillin
(Amoxicillin)
Acidophyllus
Carafate
(Sucralfate)
Tamoxifen(Tamoxifen)
Prilosec(Omeprazole)
Xanax (Alprazolam)
Flexeril
(Cyclobenzaprine
Hydrochloride)
Celexa (Citalopram
Hydrobromide)
Ambien (Zolpidem
Tartrate)
Multi -Vits
C
C
C
C
C
C
C
C
C
C
Date:10/22/02ISR Number: 3997498-XReport Type:Expedited (15-DaCompany Report #NSADSS2002037454
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abdominal Pain
Chromaturia
Decreased Appetite
Haematochezia
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Depakote(Valproate
Semisodium)
C
SEE IMAGE, 1
Vomiting
IN 1 DAY(S),
Weight Decreased
ORAL
Manufacturer
Route
ORAL
Date:10/22/02ISR Number: 3997822-8Report Type:Expedited (15-DaCompany Report #NSADSS2002032842
Age:42 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Death
Required
Intervention to
Prevent Permanent
Impairment/Damage
PT
Report Source
Product
Coma
Convulsion
Drug Ineffective
Literature
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
Bupropion Sr
(Amfebutamone)
Chlordiazepoxide/Cli
dinium (Nirvaxal)
Singulair
(Montelukast Sodium)
Levothyroxine Sodium
(Levothyroxine)
Date:10/22/02ISR Number: 3997826-5Report Type:Expedited (15-DaCompany Report #NSADSS2002032843
Age:42 YR
Gender:Male
I/FU:F
Outcome
Death
Hospitalization 18-Aug-2005
Page: 300
11:49 AM
Role
PS
C
C
C
C
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Initial or Prolonged
Required
Intervention to
Prevent Permanent
Dose
Duration
Impairment/Damage
PT
Report Source
Product
Role
Brain Herniation
Brain Oedema
Cardiomegaly
Cerebral Artery Occlusion
Literature
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Bupropion
(Amfebutamone)
SS
Manufacturer
Route
ORAL
ORAL
Coma
Completed Suicide
Cyanosis
Hepatosplenomegaly
Loss Of Consciousness
Moaning
Pulmonary Congestion
Renal Failure
Respiratory Failure
Retroperitoneal
Haemorrhage
Shock
Ventricular Hypertrophy
Date:10/22/02ISR Number: 3998212-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE03132
Age:16 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Electrocardiogram Pq
Interval Prolonged
Hyperhidrosis
Loss Of Consciousness
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
20 MG/DAY,
Somnolence
ORAL
Ventricular Extrasystoles
Date:10/23/02ISR Number: 3999526-4Report Type:Expedited (15-DaCompany Report #PHEH2002US09000
Age:13 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Nerve Block
Consumer
Focalin
Duration
Role
Manufacturer
Route
Neuropathy Peripheral
Peroneal Nerve Palsy
(Dexmethylphenidate
Hydrochloride)
Tablet
Ritalin (La
(Methylphenidate
Hydrochloride)
Extended Release
Capsules
PS
SS
Date:10/23/02ISR Number: 3999617-8Report Type:Expedited (15-DaCompany Report #A0383130A
Age:42 YR
Gender:
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Completed Suicide
Intentional Misuse
Literature
Health
Professional
Wellbutrin
Unspecified Tablet
(Bupropion
Hydrochloride)
PS
Methylphenidate
(Formulation
Unknown)
(Methylphenidate)
SS
ORAL
18-Aug-2005
Page: 301
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/23/02ISR Number: 3999628-2Report Type:Expedited (15-DaCompany Report #A0383131A
Age:42 YR
Gender:
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Completed Suicide
Intentional Misuse
Literature
Health
Professional
Wellbutrin
Unspecified Tablet
(Bupropion
Hydrochloride)
PS
Methylphenidate
(Formulation
Unknown)
(Methylphenidate)
SS
Manufacturer
Route
Duration
ORAL
ORAL
Date:10/24/02ISR Number: 3996270-4Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #
Report Source
Medication Error
Date:10/24/02ISR Number: 3997493-0Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Product
Role
Metadate Cd
(Methylphenidate
Hcl, Usp)
Extended-Release
Capsules
PS
Manufacturer
Route
Duration
PT
Company Report #CTU 179404
Report Source
Product
Role
Manufacturer
Route
Ritalin Methylphenidate
(Watson)
PS
Watson
ORAL
Manufacturer
Route
Duration
Drug Effect Decreased
Pharmaceutical Product
Complaint
15 MG BID PO
Date:10/24/02ISR Number: 4000753-0Report Type:Expedited (15-DaCompany Report #CEL-2002-01172-ROC(0)
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Other
Anorexia
Growth Retardation
Foreign
Literature
Health
Professional
Methylphenidate
Tablets
(Unspecified)
(Methylphendate
Hydrochloride
PS
Fluticasone
(Fluticasone)
C
SEE IMAGE
Date:10/28/02ISR Number: 4001345-XReport Type:Expedited (15-DaCompany Report #NSADSS2002037679
Age:32 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Coordination Abnormal
Cyanosis
Oedema Peripheral
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
36 MG, 1 IN 1
Sensory Loss
DAY(S), ORAL
Tremor
18-Aug-2005
Page: 302
Manufacturer
Route
Duration
11:49 AM
Remeron
(Mirtazapine)
Effexor (Venlafaxine
Hydrochloride)
SS
SS
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/29/02ISR Number: 4001638-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB03393
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Pallor
Pancytopenia
Weight Gain Poor
Foreign
Health
Professional
Other
Methylphenidate
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
30 MG/DAY,
ORAL
Date:10/29/02ISR Number: 4001702-1Report Type:Expedited (15-DaCompany Report #PHEH2002US09182
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Completed Suicide
Health
Professional
Ritalin-Sr
(Methylphenidate
Hydrochloride) Slow
Release Tablet
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
30 MG, QD,
Date:10/29/02ISR Number: 4003196-9Report Type:Expedited (15-DaCompany Report #PHEH2002US09315
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Coronary Artery Disease
Health
Professional
Company
Representative
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Duration
Date:10/29/02ISR Number: 4003458-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE03483
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Crohn'S Disease
Gastrointestinal
Foreign
Health
Ritalin-Sr
(Methylphenidate
Duration
Role
Haemorrhage
Professional
Other
Hydrochloride) Slow
Release Tablet
PS
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
C
ORAL
ORAL
Date:10/30/02ISR Number: 4002281-5Report Type:Direct
Age:65 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Company Report #CTU 179980
Report Source
Product
Role
Manufacturer
Route
Malignant Neoplasm
Progression
Metastases To Central
D-Threo-Methylphenid
ate Hcl Celgene /
Biologics
PS
Celgene/Biologics
ORAL
Nervous System
Megace
Decadron
Toradal
Humalin 70/30
Lortab
Arimidex
C
C
C
C
C
C
Duration
5MG BID PO
18-Aug-2005
Page: 303
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/30/02ISR Number: 4004494-5Report Type:Expedited (15-DaCompany Report #NSADSS2002038373
Age:5 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Psychotic Disorder
Health
Professional
Company
Representative
Concerta (27 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
ORAL
Zoloft (Sertraline
Hydrochloride)
SS
ORAL
27 MG, 1 IN 1
DAY(S), ORAL
25 MG, ORAL
Date:10/30/02ISR Number: 4004497-0Report Type:Expedited (15-DaCompany Report #NSADSS2002038321
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Hepatic Cirrhosis
Joint Swelling
Consumer
Concerta (18 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
18 MG , 1 IN
1 DAY(S) ORAL
Date:10/31/02ISR Number: 4004157-6Report Type:Expedited (15-DaCompany Report #PHEH2002US09142
Age:18 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abdominal Pain Upper
Dilatation Ventricular
Gilbert'S Syndrome
Oesophageal Disorder
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
10 MG, TID,
Syncope
ORAL
Manufacturer
Route
Duration
ORAL
Date:11/01/02ISR Number: 4005266-8Report Type:Expedited (15-DaCompany Report #NSADSS2002038971
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Required
Intervention to
Prevent Permanent
18 MG, 1 IN 1
Impairment/Damage
DAY(S), ORAL
PT
Report Source
Product
Role
Drug Interaction
Fall
Formication
Gait Disturbance
Hallucination
Consumer
Concerta (18 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
Movement Disorder
Pelvic Pain
Self Mutilation
Tic
Tourette'S Disorder
Risperdal
(Risperidone)
Clonidine
(Clonidine)
SS
SS
Date:11/01/02ISR Number: 4005285-1Report Type:Expedited (15-DaCompany Report #NSADSS2002038993
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
36 MG, 1 IN 1
18-Aug-2005
Page: 304
11:49 AM
PT
Report Source
Product
Role
Pancreatitis
Health
Professional
Concerta (36 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
DAY(S), ORAL
18
MON
Date:11/04/02ISR Number: 4003448-2Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
ORAL
PT
Company Report #CTU 180282
Report Source
Product
Role
Ritalin
PS
Manufacturer
Route
Duration
Drug Ineffective
ORAL
Pharmaceutical Product
Complaint
Date:11/04/02ISR Number: 4003509-8Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Cylert
Ritalin
PS
SS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
Depression
Suicidal Ideation
Date:11/04/02ISR Number: 4003673-0Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Company Report #CTU 180264
PT
Company Report #CTU 180304
Report Source
Product
Role
Metadate Cd
(Methylphenidate
Hcl, Usp)
Extended-Release
Capsules 20mg
PS
Metadate Er 20mg
SS
Duration
Medication Error
20 MG
Date:11/04/02ISR Number: 4003677-8Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 180301
Report Source
Product
Duration
Medication Error
Metadate Cd
Role
(Methylphenidate
Hcl,Usp)
Extended-Release
Capsules 20mg
PS
Metadate Er 10mg
SS
20MG
Date:11/04/02ISR Number: 4003680-8Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Other
20 MG
PT
Report Source
Product
Role
Metadate Cd
PS
Metadate Er
SS
Medication Error
Route
PT
Manufacturer
Route
Company Report #CTU 180303
Report Source
Product
Role
Metadate Er Tablets
(Methylphenidate
Hydrochloride
Extended-Release
Tablets, Usp ) 20 Mg
PS
Metadate Tid 20
SS
Duration
Medication Error
20MG
18-Aug-2005
Page: 305
Manufacturer
Duration
Date:11/04/02ISR Number: 4003682-1Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Other
Company Report #CTU 180302
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/04/02ISR Number: 4006027-6Report Type:Expedited (15-DaCompany Report #NSADSS2002038539
Age:7 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abnormal Behaviour
Learning Disorder
Sleep Disorder
Consumer
Concerta (54 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
54 MG, 1 IN 1
DAY(S), ORAL;
36 MG, 1 IN 1
DAY(S, ORAL
Seroquel (Seroquel)
Ddavp (Desmopressin)
Clonidine
(Clonidine)
C
C
C
Date:11/04/02ISR Number: 4006032-XReport Type:Expedited (15-DaCompany Report #NSADSS2002038804
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Psychotic Disorder
Health
Professional
Company
Representative
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
ORAL
Date:11/04/02ISR Number: 4006036-7Report Type:Expedited (15-DaCompany Report #NSADSS2002038977
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
ORAL
PT
Report Source
Product
Role
Psychotic Disorder
Health
Professional
Company
Representative
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
Date:11/04/02ISR Number: 4006041-0Report Type:Expedited (15-DaCompany Report #NSADSS2002038971
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Required
Intervention to
Prevent Permanent
Impairment/Damage
18 MG, 1 IN 1
PT
Report Source
Product
Drug Interaction
Fall
Formication
Gait Disturbance
Hallucination
Intentional Self-Injury
Consumer
Risperdal
(Risperidone)
Concerta (18 Mg
Sustained Release
Tablet)(Methylphenid
ate Hydrochloride)
Role
Manufacturer
Route
PS
ORAL
SS
ORAL
Paralysis
DAY(S), ORAL
Pelvic Pain
Tourette'S Disorder
Date:11/05/02ISR Number: 4004000-5Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
ORAL
18-Aug-2005
Page: 306
PT
Clonidine
(Clonidine)
SS
Company Report #CTU 180356
Report Source
Product
Role
Abnormal Behaviour
Ritalin Generic
PS
Educational Problem
Pharmaceutical Product
Complaint
Methylphenidate 10mg
Apothecon
Methylphenidate 20mg
Generic
Manufacturer
Route
Duration
11:49 AM
SS
SS
ORAL
Apothecon
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/05/02ISR Number: 4006198-1Report Type:Expedited (15-DaCompany Report #CEL-2002-01236-ROC(0)
Age:16 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Pyrexia
Health
Professional
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
UNKNOWN
Date:11/05/02ISR Number: 4006938-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE03165
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Diabetes Mellitus
Non-Insulin-Dependent
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
ORAL
Ritalin-Sr
(Methylphenidate
Hydrochloride) Slow
Release Tablet
SS
ORAL
10 MG, BID,
ORAL
10 MG, QD,
ORAL
Date:11/06/02ISR Number: 4007848-6Report Type:Expedited (15-DaCompany Report #NSADSS2002037724
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
SEE IMAGE
PT
Report Source
Product
Role
Idiopathic
Thrombocytopenic Purpura
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
Date:11/06/02ISR Number: 4008530-1Report Type:Expedited (15-DaCompany Report #PHBS2002NZ12666
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Drug Abuser
Foreign
Consumer
Other
Ritaline
(Methylphenidate
Hydrochloride)
PS
Date:11/07/02ISR Number: 4005531-4Report Type:Direct
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Manufacturer
Route
Manufacturer
Route
Route
Company Report #CTU 180526
Report Source
Product
Role
Methylphenidate 10mg
Tab At Lunch
PS
Methylphenidate 20
Mg Er Morning
SS
Duration
Completed Suicide
Injury Asphyxiation
10
20 MG ER/QD
Date:11/07/02ISR Number: 4005809-4Report Type:Direct
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
BUCCAL
PT
Report Source
Product
Role
Manufacturer
Methylphenydate
Concerta Alza Corp
PS
Alza Corp
Duration
Drug Effect Decreased
Pharmaceutical Product
54 MG 1/DAY
Complaint
BUCCAL
18-Aug-2005
Page: 307
Company Report #CTU 180569
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/07/02ISR Number: 4007593-7Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Required
1 1/2 TB Q
Intervention to
BID
Prevent Permanent
Impairment/Damage
PT
Company Report #CTU 180580
Report Source
Drug Effect Decreased
Product
Ritalin
Role
5 Mg
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
PS
Pharmaceutical Product
Complaint
Date:11/07/02ISR Number: 4009219-5Report Type:Expedited (15-DaCompany Report #CEL-2002-01227-ROC (0)
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Medication Error
Literature
Health
Professional
Methylphenidate
Tablets
(Unspecified)
(Methylphenidate
Hydrochloride)
Methadone
(Methadone)
Role
Duration
PS
SS
Date:11/07/02ISR Number: 4009221-3Report Type:Expedited (15-DaCompany Report #CEL-2002-01240-ROC (0)
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abnormal Behaviour
Anger
Crying
Feeling Abnormal
Consumer
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Prozac (Fluoxetine
Hydrochloride)
C
SEE IMAGE
Hyperhidrosis
Date:11/07/02ISR Number: 4009295-XReport Type:Expedited (15-DaCompany Report #PHEH2002US09394
Age:
Gender:Male
I/FU:I
ORAL
Outcome
Dose
Other
PT
Report Source
Product
Role
Memory Impairment
Consumer
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Manufacturer
Route
Duration
2555 DAY
Date:11/07/02ISR Number: 4009322-XReport Type:Expedited (15-DaCompany Report #NSADSS2002039317
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Petit Mal Epilepsy
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Duration
ORAL
Date:11/08/02ISR Number: 4009760-5Report Type:Expedited (15-DaCompany Report #PHEH2002US09518
Age:13 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 308
PT
Diabetes Mellitus
Non-Insulin-Dependent
Increased Appetite
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Renal Disorder
Weight Increased
Dose
Report Source
Product
Role
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
20 MG, QD,
ORAL
Date:11/08/02ISR Number: 4010140-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE03018
Age:18 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Diabetes Mellitus
Foreign
Health
Professional
Other
Ritalin-Sr
(Methylphenidate
Hydrochloride) Slow
Release Tablet
PS
ORAL
Medikinet
(Methylphenidate
Hydrochloride)
SS
ORAL
Route
Duration
20MG/DAY,
ORAL
10MG/DAY,
ORAL
Date:11/12/02ISR Number: 4011629-7Report Type:Expedited (15-DaCompany Report #NSADSS2002039773
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Anorexia
Crying
Emotional Disorder
Insomnia
Weight Decreased
Consumer
Concerta (18 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
18 MG, 1 IN 1
ORAL
DAILY, ORAL
Date:11/13/02ISR Number: 4012101-0Report Type:Expedited (15-DaCompany Report #NSADSS2002039317
Age:19 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Condition Aggravated
Feeling Abnormal
Generalised
Non-Convulsive Epilepsy
Health
Professional
Concerta(Sustained
Release
Tablet)(Methylphenid
ate Hydrochloride)
PS
Zoloft (Sertraline
Hydrochloride)
C
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:11/15/02ISR Number: 4011265-2Report Type:Direct
Age:10.5 YR Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
5MG BID BRAND
PT
Drug Effect Decreased
Pharmaceutical Product
NAME
Complaint
18-Aug-2005
Page: 309
11:49 AM
Company Report #CTU 181003
Report Source
Product
Role
Generic Ritalin
PS
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/15/02ISR Number: 4014029-9Report Type:Expedited (15-DaCompany Report #PHBS2002US13526
Age:41 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Death
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Acute Respiratory
Distress Syndrome
Agitation
Coma
Pulmonary Oedema
Respiratory Disorder
Snoring
Somnolence
Stupor
Literature
Health
Professional
Methylphenidate
(Methylphenidate
Hydrochloride)Unknow
n
Methadone
(Methadone)
Cocaine(Cocaine)
PS
Manufacturer
Route
Manufacturer
Route
SS
SS
Date:11/15/02ISR Number: 4014069-XReport Type:Expedited (15-DaCompany Report #PHBS2002CA13562
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Syncope
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Duration
ORAL
20 MG/DAY,
ORAL
Date:11/15/02ISR Number: 4014249-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE03067
Age:6 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Activated Partial
Thromboplastin Time
Prolonged
Coagulation Factor Ix
Foreign
Health
Professional
Other
Ritalin
(Methylphenidate
Hydrochloride)
Tablet, 10 Mg
PS
Manufacturer
Route
Duration
5 MG, BID,
Level Decreased
ORAL
Coagulation Factor Viii
Level Decreased
Haematoma
Haemoglobin Decreased
Goldgeist (Pyrethrum
Extract, Piperonyl
Butoxide, Diethylene
Glycol,
ORAL
International Normalised
Ratio Decreased
Platelet Count Increased
Streptococcal Serology
Positive
Weight Decreased
Date:11/18/02ISR Number: 4011305-0Report Type:Direct
Age:4.5 YR Gender:Female
I/FU:I
Outcome
Dose
Other
5MG TABS PO
PT
Chlorocresol)
Infectopedicul
(Permethrin)
Solution
C
C
Company Report #CTU 181079
Report Source
Product
Role
Ritalin Generic
PS
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
1
MON
Pharmaceutical Product
Complaint
Date:11/18/02ISR Number: 4013164-9Report Type:Expedited (15-DaCompany Report #NSADSS2002041230
Age:14 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 310
PT
Report Source
Product
Hepatitis
Migraine
Consumer
Concerta (18 Mg
Sustained Release
Tablet )
Duration
11:49 AM
Role
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
(Methylphenidate
Hydrochloride)
PS
ORAL
18 MG, 1 IN 1
DAY(S), ORAL
Acetaminophen/Codein
e
(Acetaminophen/Codei
ne)
Sudafed
(Pseudoephedrine
Hydrochloride)
C
C
Date:11/18/02ISR Number: 4014524-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE03706
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Dyskinesia
Hypoglycaemia
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
25 MG/DAY,
ORAL
Date:11/19/02ISR Number: 4011732-1Report Type:Direct
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
ONCE DAILY PO
PT
Company Report #CTU 181184
Report Source
Product
Role
Drug Ineffective
Metadate Cd 20 Mg
PS
ORAL
Dyspepsia
Methyplenidate 5 Mg
SS
ORAL
TWICE DAILY
PO
Date:11/19/02ISR Number: 4012816-4Report Type:Direct
Age:4.5 YR Gender:Female
I/FU:I
Company Report #CTU 181278
Manufacturer
Route
Outcome
Dose
PT
Report Source
Product
Role
Methalphenadate 5 Mg
Tabs. = Major
Pharmaceutical
009042768-80
PS
Manufacturer
Route
Duration
Pharmaceutical Product
Complaint
ORAL
1/2 TAB PO
QAM AT 1200 +
1600
1
MON
Date:11/20/02ISR Number: 4012678-5Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 181399
Report Source
Product
Role
Generic Ritalin 5 Mg
PS
Duration
Blood Pressure Increased
Headache
Pharmaceutical Product
Complaint
Date:11/20/02ISR Number: 4015262-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE03748
Age:12 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 311
PT
Activated Partial
Thromboplastin Time
Prolonged
Autoimmune Thyroiditis
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Blood Creatinine
Increased
Blood Urea Increased
Dose
Report Source
Product
Role
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
Weight Increased
ORAL
10 MG, BID,
ORAL
Date:11/20/02ISR Number: 4015472-4Report Type:Expedited (15-DaCompany Report #PHBS2002CA13834
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Psychotic Disorder
Foreign
Consumer
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
Ritalin-Sr
(Methylphenidate
Hydrochloride)
Tablet
Role
Manufacturer
Route
Manufacturer
Route
Duration
PS
SS
Date:11/20/02ISR Number: 4015682-6Report Type:Expedited (15-DaCompany Report #PHBS2002JP13750
Age:19 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Life-Threatening
ORAL
PT
Report Source
Product
Cardiac Arrest
Hyperpyrexia
Loss Of Consciousness
Overdose
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Unknown
Anafranil
(Clomipramine
Hydrochloride)
Tablet
Role
PS
SS
ORAL
Date:11/21/02ISR Number: 4016888-2Report Type:Expedited (15-DaCompany Report #2002-101654-NL
Age:32 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Coordination Abnormal
Cyanosis
Health
Professional
Remeron
Concerta
PS
SS
Effexor
SS
Manufacturer
Route
Duration
ORAL
36 MG DAILY
Faecal Incontinence
ORAL
Oedema Peripheral
Sensory Loss
Tremor
Urinary Incontinence
Date:11/22/02ISR Number: 4014506-0Report Type:Direct
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 181577
Report Source
Product
Role
Manufacturer
Route
Drug Ineffective
Dyspepsia
Metadate Cd 20mg
Celltech
PS
Celltech
ORAL
Pharmaceutical Product
Complaint
Methyphenidate 5mg
Geneva
SS
Geneva
ORAL
Duration
ONCE DAILY PO
TWICE DAILY
PO
18-Aug-2005
Page: 312
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/25/02ISR Number: 4017279-0Report Type:Expedited (15-DaCompany Report #CEL-2002-01391-ROC(0)
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Grand Mal Convulsion
Foreign
Literature
Health
Professional
Methylphenidate
Tablets
(Unspecified)
(Methylphenidate
Hydrochloride)
PS
Bupropion
(Bupropion)
SS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
60 MG (UNK,
DAILY)
SEE IMAGE
4
WK
Date:11/25/02ISR Number: 4017426-0Report Type:Expedited (15-DaCompany Report #MK200211-0156-1
Age:19 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization ONE TIME
Initial or Prolonged
PT
Report Source
Product
Role
Cardiac Arrest
Foreign
Anafranil
PS
Ritalin
SS
Hyperpyrexia
Loss Of Consciousness
Overdose
Date:11/26/02ISR Number: 4015461-XReport Type:Direct
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Required
20MG PO QAM
Intervention to
Prevent Permanent
Impairment/Damage
PT
Anorexia
Attention
Deficit/Hyperactivity
Disorder
Condition Aggravated
Company Report #CTU 181674
Report Source
Product
Role
Ritalin Er
PS
ORAL
Date:11/26/02ISR Number: 4017452-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE03759
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Thyroid Stimulating
Hormone Increased
Thyroxine Normal
Tri-Iodothyronine Normal
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:11/26/02ISR Number: 4017889-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB03612
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Disability
PT
Report Source
Product
Role
Manufacturer
Route
Drug Interaction
Erectile Dysfunction
Priapism
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
ORAL
Risperidone
(Risperidone)
SS
ORAL
30 MG/DAY,
ORAL
ONCE/SINGLE,
ORAL
18-Aug-2005
Page: 313
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/26/02ISR Number: 4017891-9Report Type:Expedited (15-DaCompany Report #PHFR2002GB03782
Age:16 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Systemic Lupus
Erythematosus
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Unknown
PS
Manufacturer
Route
Manufacturer
Route
Duration
Date:11/26/02ISR Number: 4017924-XReport Type:Expedited (15-DaCompany Report #PHBS2002CA13562
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Blindness
Orthostatic Hypotension
Syncope
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
Visual Disturbance
Other
Duration
ORAL
20 MG/DAY,
ORAL
Date:11/26/02ISR Number: 4018147-0Report Type:Expedited (15-DaCompany Report #HQ5434520NOV2002
Age:50 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Confusional State
Feeling Abnormal
Memory Impairment
Road Traffic Accident
Health
Professional
Effexor Xr
(Venlafaxine
Hydrochloride,
Capsule, Extended
Release)
PS
Allegra-D
(Fexofenadine
Hydrochloride/Pseudo
ephedrine
Hydrochloride,)
SS
600 MG 1X PER
2 DAY, ORAL
"TWICE DAILY"
Ambien (Zolpidem
Manufacturer
Route
ORAL
Tartrate,)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride,)
SS
ORAL
10 MG 1X PER
1 DAY, ORAL
20 MG DAILY,
INTERMITTENTL
Y, ORAL
Date:11/26/02ISR Number: 4018172-XReport Type:Expedited (15-DaCompany Report #PHBS2002US13526
Age:41 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Death
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 314
11:49 AM
PT
Report Source
Product
Role
Acute Respiratory
Distress Syndrome
Agitation
Coma
Oxygen Saturation
Decreased
Pulmonary Oedema
Respiration Abnormal
Snoring
Somnolence
Stupor
Literature
Health
Professional
Methylphenidate
(Methylphenidate
Hydrochloride)
Unknown
Methadone
(Methadone)
Cocaine (Cocaine)
PS
SS
SS
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/27/02ISR Number: 4015700-5Report Type:Direct
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Company Report #USP 55367
Report Source
Product
Role
Manufacturer
PS
Alza
SS
A;Za
Route
Duration
Medication Error
Concerta
(Methlphenidate
Hydrochloride)
Concerta
(Methlphenidate
Hydrochloride)
Date:11/29/02ISR Number: 4019720-6Report Type:Expedited (15-DaCompany Report #CEL-2002-01441-ROC (0)
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Asthenia
Blindness Transient
Blindness Unilateral
Hypoaesthesia
Health
Professional
Metadate Cd Capsules
20
Mg(Methylphenidate
Hydrochloride)
PS
Geodon (Ziprasidone
Hydrochloride)
SS
Duration
60 MG(60 MG,
Muscle Disorder
DAILY)/
Vision Blurred
SEVERAL
MONTHS AGO-
LOW DOSE
(DAILY)/
SEVERAL
MONTHS AGOEffexor(Venlafaxine
Hydrochloride)
Wellbutrin - Slow
Release (Bupropion
Hydrochloride)
C
C
Manufacturer
Route
Date:11/29/02ISR Number: 4027447-XReport Type:Periodic
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
Company Report #NSADSS2002039219
PT
Report Source
Product
Role
Abdominal Pain
Weight Decreased
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:11/29/02ISR Number: 4027448-1Report Type:Periodic
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #NSADSS2002038359
PT
Report Source
Product
Role
Growth Retardation
Weight Gain Poor
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
ORAL
Date:11/29/02ISR Number: 4027450-XReport Type:Periodic
Age:9 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 315
Manufacturer
Route
Duration
PT
Aggression
Emotional Disorder
Personality Disorder
11:49 AM
Company Report #NSADSS2002037041
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Weight Decreased
Dose
Report Source
Product
Role
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
18 MG, 2 IN 1
DAY(S), ORAL
Date:11/29/02ISR Number: 4027452-3Report Type:Periodic
Age:6 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
Company Report #NSADSS2002034260
PT
Report Source
Product
Role
Anorexia
Insomnia
Weight Gain Poor
Consumer
Concerta (18 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Ritalin
(Methylphenidate
Hydrochloride)
Imipramine
(Imipramine)
Date:11/29/02ISR Number: 4027454-7Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
C
C
Company Report #NSADSS2002030960
PT
Report Source
Product
Role
Convulsion
Epileptic Aura
Headache
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
Proventil
(Salbutamol)
Rhinocort
(Budesonide)
C
C
ORAL
Date:11/29/02ISR Number: 4027459-6Report Type:Periodic
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
Company Report #NSADSS2002038799
PT
Report Source
Product
Role
Anorexia
Muscular Weakness
Weight Decreased
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
DAY(S), ORAL
Date:11/29/02ISR Number: 4027501-2Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Aggression
Anorexia
Weight Decreased
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
SEE IMAGE
18-Aug-2005
Page: 316
Company Report #NSADSS2002029232
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/03/02ISR Number: 4021755-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE01782
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Arrhythmia
Blood Pressure Increased
Bundle Branch Block Right
Cardiac Murmur
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
10 MG, QD
Ejection Fraction
ORAL
Decreased
Electrocardiogram
Abnormal
Electrocardiogram T Wave
Amplitude Decreased
Fatigue
Heart Sounds Abnormal
Pulmonary Hypertension
Pulmonary Valve
Incompetence
Thrombosis
Tricuspid Valve
Incompetence
Ventricular Hypertrophy
Date:12/04/02ISR Number: 4019552-9Report Type:Direct
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Required
20 MG PO QAM
Intervention to
Prevent Permanent
Impairment/Damage
PT
Anorexia
Company Report #CTU 182123
Report Source
Product
Role
Ritalin Er
PS
Attention
Deficit/Hyperactivity
Disorder
Disease Recurrence
Date:12/04/02ISR Number: 4022327-8Report Type:Expedited (15-DaCompany Report #PHNU2002DE03908
Age:8 YR
Gender:Male
I/FU:I
Manufacturer
Route
ORAL
Outcome
Dose
Other
PT
Report Source
Product
Role
Disturbance In Attention
Fatigue
Visual Acuity Reduced
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
15MG/DAY,
ORAL
Date:12/05/02ISR Number: 4021652-4Report Type:Expedited (15-DaCompany Report #NSADSS2002043428
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
18 MG 1 IN 1
DAY(S), ORAL
18-Aug-2005
Page: 317
11:49 AM
PT
Report Source
Product
Role
Delusion
Emotional Disorder
Psychotic Disorder
Foreign
Study
Health
Professional
Concerta(18 Mg
Sustained Release
Tablet)(Methylphenid
ate Hydrochloride)
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/05/02ISR Number: 4025837-2Report Type:Periodic
Age:51 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
Company Report #HQ1166204MAR2002
PT
Report Source
Product
Role
Manufacturer
Route
Hypertension
Vision Blurred
Health
Professional
Effexor Xr
(Venlafaxine
Hydrochloride,
Capsule, Extended
Release)
PS
ORAL
Methylphenidate-Slow
Release
(Methylphenidate
Hydrochloride, )
SS
ORAL
Unspecified Hormone
Replacement Therapy
Agent (Unspecified
Hormone Replacement
Therapy Agent)
..
C
C
Duration
3.75 MG ;
112.5 MG :1X
PER 1 DAY,
ORAL
20 MG 1X PER
1 DAY, ORAL
Date:12/06/02ISR Number: 4020328-7Report Type:Direct
Age:10.5 YR Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 182296
Report Source
Product
Role
Manufacturer
Route
Abdominal Discomfort
Abnormal Behaviour
Generic Ritalin 5 Mg
Tab
PS
ORAL
Aggression
Adderall 10mg Tab
SS
ORAL
Decreased Appetite
Concerta 18 Mg Tab
SS
ORAL
Duration
5 MG PO BID
10 MG PO QD
18 MG PO QD
Drug Ineffective
Educational Problem
Headache
Hostility
Insomnia
Irritability
Pharmaceutical Product
Complaint
Psychomotor Hyperactivity
Pyromania
Vomiting
Date:12/06/02ISR Number: 4022696-9Report Type:Expedited (15-DaCompany Report #MK200212-0087-1
Age:
Gender:
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 318
11:49 AM
PT
Report Source
Product
Role
Drug Withdrawal Syndrome
Neonatal
Maternal Drugs Affecting
Foetus
Foreign
Anafranil 25 Mg
Capsules 100
Ritalin
Impromen
Meilax
Depromel
Amoxan
PS
SS
SS
SS
SS
SS
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/06/02ISR Number: 4022807-5Report Type:Expedited (15-DaCompany Report #NSADSS2002038373
Age:4 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Formication
Hallucination, Tactile
Psychotic Disorder
Screaming
Health
Professional
Company
Representative
Concerta (27 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
ORAL
Zoloft (Sertraline
Hydrochloride)
SS
ORAL
Clonidine
C
27 MG, 1 IN 1
DAY(S), ORAL
25 MG, ORAL
Date:12/09/02ISR Number: 4023099-3Report Type:Expedited (15-DaCompany Report #PHBS2002JP14252
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Foreign
Health
Anafranil(Clomiprami
ne) Unknown
PS
Ritaline(Methylpheni
date Hydrochloride)
Unknown
SS
Depromel(Fluvoxamine
)
SS
Duration
TRANSPLACENTAL
Drug Exposure Via Breast
Milk
UNK, UNK,
Drug Withdrawal Syndrome
Professional
TRANSPLACENTA
Neonatal
Other
L
TRANSPLACENTAL
Maternal Drugs Affecting
Foetus
Pregnancy
UNK, UNK,
TRANSPLACENTA
L
TRANSPLACENTAL
TRANSPLACENTA
L
UNK, UNK,
Manufacturer
Route
TRANSPLACENTAL
Meilax(Ethyl
Loflazepate)
SS
Amoxan(Amoxapine)
SS
Impromen(Bromperidol
)
SS
UNK, UNK,
TRANSPLACENTA
L
TRANSPLACENTAL
UNK, UNK,
TRANSPLACENTA
L
TRANSPLACENTAL
UNK, UNK,
TRANSPLACENTA
L
Date:12/09/02ISR Number: 4023107-XReport Type:Expedited (15-DaCompany Report #PHBS2002NO14330
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Diabetes Mellitus
Insulin-Dependent
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
10 MG, TID,
Other
ORAL
Dexamin (Amfetamine
Sulfate)
Dexidrine
(Dexamfetamine
Sulfate)
18-Aug-2005
Page: 319
11:49 AM
C
C
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/09/02ISR Number: 4023108-1Report Type:Expedited (15-DaCompany Report #PHBS2002NO14329
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Diabetes Mellitus
Insulin-Dependent
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
SEE IMAGE,
Other
ORAL
Date:12/09/02ISR Number: 4023111-1Report Type:Expedited (15-DaCompany Report #PHRM2002FR02903
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abdominal Pain
Arthralgia
Rash
Rash Macular
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
SEE IMAGE
Systemic Inflammatory
ORAL
Response Syndrome
Urinary Tract Infection
Vomiting
Weight Decreased
Date:12/09/02ISR Number: 4023119-6Report Type:Expedited (15-DaCompany Report #PHBS2002NO14341
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Disability
10 MG, TID,
PT
Report Source
Product
Role
Diabetes Mellitus
Insulin-Dependent
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
Other
ORAL
Manufacturer
Route
ORAL
Date:12/09/02ISR Number: 4023467-XReport Type:Expedited (15-DaCompany Report #2002069463
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
DAILY
PT
Report Source
Product
Role
Blindness Transient
Health
Geodon (Ziprasidone)
PS
Blindness Unilateral
Multiple Sclerosis
Professional
Methylphenidate
Hydrochloride
SS
Manufacturer
Route
Manufacturer
Route
Duration
60 MG (DAILY)
Vision Blurred
Date:12/10/02ISR Number: 4022052-3Report Type:Direct
Age:47 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization 400MG DAILY
Initial or Prolonged
PO [CHRONIC]
PT
Hepatitis
Venlafaxine
Hydrochloride
Bupropion
Hydrochloride
C
C
Company Report #CTU 182491
Report Source
Product
Role
Methylphenidate
PS
Ethanol
SS
Cocaine
SS
Barbiturates
SS
Opiates
SS
CHRONIC
CHRONIC
CHRONIC
18-Aug-2005
Page: 320
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/10/02ISR Number: 4024989-8Report Type:Expedited (15-DaCompany Report #PHBS2002JP13750
Age:19 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Manufacturer
Route
Blood Creatine
Phosphokinase Increased
Convulsion
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
ORAL
Depression
Other
Anafranil
(Clomipramine
Hydrochloride)Tablet
SS
ORAL
Condition (Diazepam)
SS
Toledomin
(Milnacipran
Hydrochloride)
SS
Imidiol
SS
Normaln
(Amitriptyline
Hydrochloride)
SS
20 MG/DAY,
ORAL
Hallucination, Auditory
Hepatic Function Abnormal
Hyperpyrexia
10 MG, TID,
Insomnia
ORAL
Memory Impairment
2 MG, TID,
Overdose
UNK
Respiratory Arrest
Vomiting
15 MG, TID,
UNK
200 MG/DAY
UNK, UNK, UNK
Date:12/12/02ISR Number: 4026382-0Report Type:Expedited (15-DaCompany Report #PHEH2002US08968
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization 20 MG,
Initial or Prolonged
ONCE/SINGLE/
PT
Report Source
Product
Role
Dyskinesia
Other
Ritalin La
PS
Hallucination
Muscle Contractions
ORAL
Manufacturer
Route
ORAL
Involuntary
Pain In Extremity
Tic
Claritin
(Loratadine)
Antibiotics
C
C
Date:12/12/02ISR Number: 4026394-7Report Type:Expedited (15-DaCompany Report #PHEH2002US09000
Age:13 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
C-Reactive Protein
Increased
Neuropathy Peripheral
Peroneal Nerve Palsy
Consumer
Focalin
(Dexmethylphine
Hydrochloride)
Tablet
PS
Ritalin La
(Methylphenidate
Hydrochloride)
Extended Release
Capsules
SS
Duration
10 MG, BID,
20 MG, QD
Date:12/16/02ISR Number: 4026771-4Report Type:Expedited (15-DaCompany Report #MK200211-0156-2
Age:19 YR
Gender:Female
I/FU:F
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 321
11:49 AM
PT
Blood Creatine
Phosphokinase Increased
Convulsion
Drug Ineffective
Hallucination, Auditory
Hepatic Function Abnormal
Hyperphagia
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Hyperpyrexia
Insomnia
Lethargy
Report Source
Product
Role
Loss Of Consciousness
Foreign
Anafranil
PS
Memory Impairment
Overdose
Respiratory Arrest
Milnacipran
Hydrochloride
Ritalin
SS
SS
Suicidal Ideation
Ritalin
SS
Condition
Normaln
Imidiol
SS
SS
SS
Manufacturer
Route
Manufacturer
Route
Duration
60MG DAILY
40MG/DAY
ONE TIME DOSE
Vomiting
30 TABLETS
FOR SUICIDE
ATTEMPT
Date:12/16/02ISR Number: 4027547-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE04059
Age:
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Sudden Cardiac Death
Ventricular Extrasystoles
Foreign
Health
Professional
Other
Ritalin-Sr
(Methylphenidate
Hydrochloride) Slow
Release Tablet
PS
ORAL
Zoloft (Sertraline
Hydrochloride)
SS
ORAL
Duration
60MG/DAY,
ORAL
100 MG/DAY,
ORAL
Date:12/16/02ISR Number: 4028166-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB04019
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Allergic Granulomatous
Angiitis
Foreign
Health
Methylphenidate
Hydrochloride
PS
Manufacturer
Route
Duration
ORAL
ORAL
Professional
Other
Date:12/18/02ISR Number: 4025741-XReport Type:Direct
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 182899
Report Source
Product
Role
Ritalin Methylphenidate
PS
Manufacturer
Route
Duration
Drug Effect Decreased
Pharmaceutical Product
ORAL
5MG - PO AM
Complaint
Date:12/18/02ISR Number: 4029125-XReport Type:Expedited (15-DaCompany Report #NSADSS2002045737
Age:14 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Confusional State
Hypertension
Health
Professional
Concerta (Sustained
Release
Tablet)(Methylphenid
ate Hydrochloride)
PS
Celexa (Citalopram
Hydrobromide)
C
Duration
18 MG, 1 IN 1
DAY(S), ORAL;
SEE IMAGE
18-Aug-2005
Page: 322
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/18/02ISR Number: 4029213-8Report Type:Expedited (15-DaCompany Report #CEL-2002-01509-SLO(0)
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Eosinophilia
Neutrophil Count
Decreased
Shift To The Left
Foreign
Health
Professional
Equasym (Strength
Unspecified)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
30 MG (10 MG,
White Blood Cell Count
THREE TIMES
Decreased
DAILY), PO
Date:12/18/02ISR Number: 4029418-6Report Type:Expedited (15-DaCompany Report #A0387790A
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Confusional State
Drug Interaction
Grand Mal Convulsion
Somnolence
Foreign
Literature
Health
Professional
Wellbutrin
Unspecified Tablet
(Bupropion
Hydrochloride)
PS
Methylphenidate
(Formulation Unknown
) (Methylphenidate)
SS
Manufacturer
Route
Duration
ORAL
PER DAY/ORAL
60 MG/PER DAY
Date:12/19/02ISR Number: 4029731-2Report Type:Expedited (15-DaCompany Report #PHBS2002US15140
Age:45 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abnormal Behaviour
Depression
Drug Dependence
Drug Withdrawal Syndrome
Literature
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
Unknown
PS
Manufacturer
Route
Duration
SEE IMAGE
Hypertension
Paranoia
Personality Disorder
Marijuana (Cannabis)
Vicodin
Amfetamine
C
C
ORAL
(Amfetamine)
Opiates
Bupropion
(Bupropion)
C
C
C
Date:12/19/02ISR Number: 4030288-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB04081
Age:
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Circulatory Collapse
Shock
Foreign
Health
Professional
Other
Ritalin-Sr(Methylphe
nidate
Hydrochloride) Slow
Release Tablet
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:12/20/02ISR Number: 4028717-1Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
30MG DAILY
PT
Bone Marrow Depression
Laboratory Test Abnormal
Company Report #CTU 183140
Report Source
Product
Remeron
Organon
Role
Manufacturer
Route
PS
Organon
ORAL
SS
Mcneil
ORAL
30mg
Pyrexia
ORAL
White Blood Cell Count
Decreased
54MG DAILY
ORAL
18-Aug-2005
Page: 323
11:49 AM
Concerta Er 54mg
Mcneil
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/20/02ISR Number: 4030477-5Report Type:Expedited (15-DaCompany Report #NSADSS2002043428
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Delusion
Emotional Disorder
Psychotic Disorder
Foreign
Study
Health
Professional
Concerta (18 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
18 MG, 1 IN 1
DAY (S), ORAL
Date:12/23/02ISR Number: 4032832-6Report Type:Expedited (15-DaCompany Report #ALZ-13483
Age:38 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Iron Deficiency Anaemia
Serum Sickness
Health
Professional
Concerta (54 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Ortho Tri-Cyclen
Tablets (Tablet
(Acne))
(Norgestimate/Ethiny
lestradiol)
SS
Manufacturer
Route
Duration
54 MG, 1 IN 1
DAYS (S),
ORAL
1 IN 1 DAY
(S)
Celexa (Citalopram
Hydrobromide)
Seroquel (Seroquel)
Nexium (Esomeprazole
Magnesium)
Singulair
(Montelukast Sodium)
Advair
C
C
C
C
C
ORAL
Nasonex (Mometasone
Furoate)
Albuterol
(Salbutamol)
C
C
Date:12/23/02ISR Number: 4032893-4Report Type:Expedited (15-DaCompany Report #NSADSS2002046188
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
ORAL
PT
Report Source
Product
Role
Congenital Cardiovascular
Health
Concerta
PS
Anomaly
Electrocardiogram Qt
Prolonged
Sudden Cardiac Death
Professional
Manufacturer
Route
Duration
ORAL
Date:12/26/02ISR Number: 4034273-4Report Type:Expedited (15-DaCompany Report #PHEH2002US09315
Age:
Gender:
I/FU:F
Outcome
Dose
Death
18-Aug-2005
Page: 324
PT
Report Source
Product
Role
Coronary Artery Disease
Health
Professional
Company
Representative
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Duration
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/26/02ISR Number: 4035002-0Report Type:Expedited (15-DaCompany Report #PHEH2001US10491
Age:
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Death
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Manufacturer
Route
Duration
Date:12/26/02ISR Number: 4035236-5Report Type:Expedited (15-DaCompany Report #PHBS2002JP13750
Age:19 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Blood Creatine
Phosphokinase Increased
Convulsion
Hallucination, Auditory
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
ORAL
Hyperphagia
Hyperpyrexia
Insomnia
Lethargy
Anafranil
(Clomipramine
Hydrochloride)
Tablet
SS
ORAL
Liver Function Test
Condition (Diazepam)
SS
Loss Of Consciousness
Memory Impairment
Overdose
Toledomin
(Milnacipran
Hydrochloride)
SS
Respiratory Arrest
Imidiol()
SS
Suicidal Ideation
Vomiting
Normaln
(Amitriptyline
Hydrochloride)
SS
Diazepam (Diazepam)
SS
SEE IMAGE
SEE IMAGE
2 MG, TID;
Abnormal
25 MG/DAY
15 MG, TID
150 MG/DAY
SEE IMAGE
15 MG/DAY
Date:12/26/02ISR Number: 4035272-9Report Type:Expedited (15-DaCompany Report #2002069463
Age:
Gender:Female
I/FU:F
Outcome
Dose
Duration
Other
40 MG (BID),
PT
Report Source
Product
Role
Manufacturer
Route
Asthenia
Health
Geodon (Ziprasidone)
PS
ORAL
Blindness Transient
Professional
Methylphenidate
Hydrochloride
SS
ORAL
ORAL
Feeling Abnormal
Hypoaesthesia
60 MG
Multiple Sclerosis
(DAILY), ORAL
Vision Blurred
Venlafaxine
Hydrochloride
Bupropion
Hydrochloride
C
C
Date:12/30/02ISR Number: 4035840-4Report Type:Expedited (15-DaCompany Report #PHBS2002JP15313
Age:12 YR
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Growth Retardation
Foreign
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
PS
Other
Depromel
(Fluvoxamine)
C
ORAL
18-Aug-2005
Page: 325
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/30/02ISR Number: 4035868-4Report Type:Expedited (15-DaCompany Report #00HQ-10193
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Coronary Artery Disease
Coronary Artery
Insufficiency
Myocardial Ischaemia
Sudden Cardiac Death
Literature
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Duration
Date:12/30/02ISR Number: 4035935-5Report Type:Expedited (15-DaCompany Report #PHEH2002US10433
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Leukocytoclastic
Vasculitis
Pharmaceutical Product
Complaint
Consumer
Methylphenidate
(Methylphenidate
Hydrochloride)
Tablet
PS
Duration
ORAL
10 MG, TID,
ORAL
Date:12/30/02ISR Number: 4036065-9Report Type:Expedited (15-DaCompany Report #EMADSS2002007059
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Disability
1 MG, 1 IN 1
Required
TIME (S),
Intervention to
ORAL
Prevent Permanent
Impairment/Damage
30 MG, DAILY,
PT
Report Source
Product
Role
Manufacturer
Drug Interaction
Erectile Dysfunction
Post Procedural
Foreign
Health
Professional
Risperdal
(Unspecified)
(Risperidone)
PS
ORAL
Methylphenidate
(Methylphenidate)
SS
ORAL
Route
Complication
Priapism
ORAL
Clonidine
(Clonidine)
C
Date:12/30/02ISR Number: 4036106-9Report Type:Expedited (15-DaCompany Report #PHBS2002JP15313
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Growth Retardation
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
Other
Depromel
(Fluvoxamine)
SS
Manufacturer
Route
Duration
ORAL
ORAL
Date:12/30/02ISR Number: 4036185-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE03748
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Activated Partial
Thromboplastin Time
Prolonged
Foreign
Health
Professional
Ritaline(Methylpheni
dat Hydrochloride)
Tablet
PS
Autoimmune Thyroiditis
Other
10 MG, BID,
ORAL
Blood Creatinine
Increased
Blood Urea Increased
Hypothyroidism
Weight Increased
18-Aug-2005
Page: 326
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/30/02ISR Number: 4036540-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB04247
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Photosensitivity Reaction
Systemic Lupus
Erythematosus
Foreign
Health
Professional
Other
Ritaline(Methylpheni
date Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Duration
Date:01/02/03ISR Number: 4038472-7Report Type:Expedited (15-DaCompany Report #NSADSS2002045734
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hypoglycaemia
Consumer
Concerta (18 Mg
Sustained Release
Tablet)(Methylphenid
ate
PS
Duration
ORAL
18 MG, 1 IN 1
DAY(S), ORAL
Effexor (Venlafaxine
Hydrochloride)
Ultralente (Insulin
Zinc Suspension)
Humalog (Insulin
Lispro)
Date:01/06/03ISR Number: 4036893-XReport Type:Direct
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
Disability
Required
Intervention to
Prevent Permanent
Impairment/Damage
PT
Tourette'S Disorder
SS
C
C
Company Report #CTU 183819
Report Source
Product
Role
Ritalin
PS
Manufacturer
Route
Date:01/06/03ISR Number: 4039988-XReport Type:Expedited (15-DaCompany Report #NSADSS2002047632
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Weight Decreased
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Zoloft (Sertraline
Hydrochloride)
C
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
DAY(S), ORAL;
36 MG, 1 IN 1
DAY(S), ORAL
Date:01/07/03ISR Number: 4040233-XReport Type:Expedited (15-DaCompany Report #NSADSS2002046654
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
SEE IMAGE
18-Aug-2005
Page: 327
PT
Report Source
Product
Role
Anorexia
Leukopenia
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Concerta (Sustained
Release Tablet )
(Methylphenidate
Hydrochloride)
SS
ORAL
36 MG, 1 IN 1
DAY(S); ORAL,
18 MG, 1 IN 1
DAY(S); ORAL;
27 MG, 1 IN 1
Date:01/08/03ISR Number: 4040543-6Report Type:Expedited (15-DaCompany Report #NSADSS2003000409
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Dysarthria
Dyskinesia
Oral Intake Reduced
Pharyngitis
Torticollis
Health
Professional
Concerta (36 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Evening Primrose Oil
(Evening Primrose
Oil)
Fish Oil (Fish Oil)
C
C
Manufacturer
Route
ORAL
36 MG, 1 IN 1
DAY (S), ORAL
Date:01/09/03ISR Number: 4039789-2Report Type:Direct
Age:19 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization 60MG DAILY
Initial or Prolonged
40MG /DAY
PT
Company Report #CTU 184177
Report Source
Product
Role
Blood Creatine
Anafranil
PS
Phosphokinase Increased
Convulsion
Depression
Milnacipran
Hydrochloride
Ritalin
SS
SS
Manufacturer
Route
Hallucination, Auditory
Ritalin
SS
Condition
Normaln
Imidol
SS
SS
SS
ONE TIME DOSE
Hepatic Function Abnormal
30 TABLETS
Hyperphagia
FOR SUICIDE
Hyperpyrexia
ATTEMPT
Hypersomnia
Insomnia
Lethargy
Loss Of Consciousness
Memory Impairment
Overdose
Respiratory Arrest
Suicidal Ideation
Vomiting
Date:01/10/03ISR Number: 4041128-8Report Type:Expedited (15-DaCompany Report #NSADSS2002034127
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abdominal Pain Lower
Anorexia
Blood Pressure Increased
Caecitis
Vomiting
Health
Professional
Concerta (36 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Albuterol
(Salbutamol)
C
36 MG, 1 IN 1
DAY (S), ORAL
18-Aug-2005
Page: 328
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Prevacid
(Lansoprazole)
C
Date:01/10/03ISR Number: 4041278-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE04262
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Impaired Healing
Peripheral Coldness
Peripheral Vascular
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
ORAL
Disorder
Other
Ritalin-Sr
(Methylphenidate
Hydrochloride) Slow
Release Tablet
SS
ORAL
Duration
ORAL
1 DF, QD,
ORAL
Date:01/10/03ISR Number: 4041329-9Report Type:Expedited (15-DaCompany Report #PHBS2002JP15313
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Growth Retardation
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
ORAL
Other
Depromel
(Fluvoxamine)
SS
ORAL
Pydoxal (Pyridoxal
Phosphate)
C
Duration
20 MG/D, ORAL
25 MG/D, ORAL
Date:01/13/03ISR Number: 4041694-2Report Type:Expedited (15-DaCompany Report #NSADSS2003000619
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization -
PT
Report Source
Product
Abdominal Pain Upper
Consumer
Concerta (Sustained
Role
Manufacturer
Route
Initial or Prolonged
Convulsion
Hallucination
Loss Of Consciousness
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Nausea
Vomiting
Clonidine
(Clonidine)
C
ORAL
SEE IMAGE
Date:01/13/03ISR Number: 4041852-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB03612
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Disability
PT
Report Source
Product
Role
Manufacturer
Route
Drug Interaction
Erectile Dysfunction
Priapism
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
ORAL
Risperidone(Risperid
one)
SS
ORAL
Clonidine
(Clonidine)
C
30 MG/DAY,
ORAL
ONCE/SINGLE,
ORAL
18-Aug-2005
Page: 329
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/13/03ISR Number: 4041859-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB03782
Age:16 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Systemic Lupus
Erythematosus
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Duration
Date:01/13/03ISR Number: 4041910-7Report Type:Expedited (15-DaCompany Report #PHBS2002NL15740
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Agranulocytosis
Stomatitis
Vomiting
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Duration
ORAL
ORAL
Other
Date:01/14/03ISR Number: 4042683-4Report Type:Expedited (15-DaCompany Report #2002-101654-NL
Age:32 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Coordination Abnormal
Cyanosis
Health
Professional
Remeron
Concerta
PS
SS
Effexor
SS
Manufacturer
Route
Duration
36 MG DAILY
Faecal Incontinence
ORAL
Muscle Spasms
Oedema Peripheral
Sensory Loss
Tremor
Urinary Incontinence
Date:01/16/03ISR Number: 4042958-9Report Type:Direct
Age:
Gender:
I/FU:I
Company Report #CTU 184758
ORAL
Outcome
Dose
PT
Report Source
Product
Role
Methylphenidate Hcl,
Usp
PS
Manufacturer
Route
Manufacturer
Route
Duration
Medication Error
20MG CAPSULES
IN DOSE PACKS
CONTAINING 30
CAPSULES EACH
Date:01/17/03ISR Number: 4044305-5Report Type:Expedited (15-DaCompany Report #NSADSS2003002020
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18 MG, 1 IN 1
DAY (S),
ORAL; 36 MG,
1 IN 1
DAY(S), ORAL
18-Aug-2005
Page: 330
PT
Report Source
Product
Role
Syncope
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/21/03ISR Number: 4045483-4Report Type:Expedited (15-DaCompany Report #PHEH2002US09142
Age:17 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Dilatation Ventricular
Gilbert'S Syndrome
Oesophageal Disorder
Syncope
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
10 MG, TID,
Ventricular Arrhythmia
ORAL
Date:01/21/03ISR Number: 4048140-3Report Type:Expedited (15-DaCompany Report #EMADSS2002007793
Age:21 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Pressure Increased
Emotional Disorder
Overdose
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
Suicide Attempt
DAY(S) ,
ORAL; 5
TABLE, 1 IN 1
TIME(S), ORAL
Date:01/23/03ISR Number: 4045531-1Report Type:Direct
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
5 MG PO A.M.
PT
Company Report #CTU 185092
Report Source
Product
Role
Manufacturer
Route
Ritalin Methylphenidate
Geneva
PS
Geneva
ORAL
Duration
Drug Effect Decreased
Pharmaceutical Product
Complaint
Date:01/23/03ISR Number: 4046107-2Report Type:Expedited (15-DaCompany Report #CEL-2002-01236-ROC(1)
Age:16 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Meningitis
Health
Professional
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Date:01/27/03ISR Number: 4048706-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE00485
Age:47 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Endometrial Hyperplasia
Psychotic Disorder
Speech Disorder
Uterine Leiomyoma
Foreign
Consumer
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Duration
ORAL
ORAL
Date:01/27/03ISR Number: 4048811-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE00479
Age:21 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
ORAL
18-Aug-2005
Page: 331
PT
Report Source
Product
Role
Persecutory Delusion
Foreign
Consumer
Other
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/27/03ISR Number: 4048813-2Report Type:Expedited (15-DaCompany Report #PHBS2003JP00907
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Foreign
Health
Ritalin(Methylphenid
ate Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Duration
Congenital Hydronephrosis
Haemangioma
TRANSPLACENTA
Maternal Drugs Affecting
TRANSPLACENTAL
Professional
L
Foetus
Spina Bifida
Other
Date:01/28/03ISR Number: 4049370-7Report Type:Expedited (15-DaCompany Report #HQ5434520NOV2002
Age:50 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Confusional State
Feeling Abnormal
Memory Impairment
Road Traffic Accident
Health
Professional
Effexor Xr
(Venlafaxine
Hydrochloride,
Capsule, Extended
Release)
PS
ORAL
Allegra-D
(Fexofenadine
Hydrochloride/
Pseudoephedrine
Hydrochloride, )
SS
ORAL
Ambien (Zolpidem
Tartrate, )
SS
ORAL
Ritalin
(Methylphenidate
Hydrocholoride,)
SS
ORAL
Duration
300 MG 2X PER
1 DAY, ORAL
1 TABLET 2X
PER 1 DAY,
ORAL
6
MON
5 MG 1X PER 1
DAY, ORAL
20 MG DAILY,
6
MON
INTERMITTENTL
Y, ORAL
Date:01/28/03ISR Number: 4049822-XReport Type:Expedited (15-DaCompany Report #NSADSS2003000409
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Dysarthria
Movement Disorder
Oligodipsia
Oral Intake Reduced
Parapharyngeal Abscess
Pharyngitis
Torticollis
Health
Professional
Concerta (36 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
Evening Primrose Oil
(Evening Primrose
Oil)
Fish Oil (Fish Oil)
PS
Date:01/29/03ISR Number: 4049815-2Report Type:Expedited (15-DaCompany Report #PHBS2003NL00948
Age:19 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 332
PT
Abdominal Distension
Blood Pressure Increased
Blood Urine Present
Fungal Infection
Lymphadenopathy
11:49 AM
C
C
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pyrexia
Stress
Dose
Report Source
Product
Role
Foreign
Consumer
Other
Ritalin(Methylphenid
ate Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:01/30/03ISR Number: 4049563-9Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
RITALIN LA 30
PT
Company Report #CTU 185648
Report Source
Condition Aggravated
Product
Role
Manufacturer
Ritalin La 30
PS
Novartis
Route
Disturbance In Attention
MG 1 Q AM
Impulsive Behaviour
Psychomotor Hyperactivity
Date:01/31/03ISR Number: 4050776-0Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Death
Company Report #CEL-2002-01433-ROC (0)
PT
Report Source
Product
Role
Death
Health
Professional
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Duration
20 MG (20 MG,
DAILY)
Date:01/31/03ISR Number: 4051164-3Report Type:Expedited (15-DaCompany Report #CEL-2002-01441-ROC (1)
Age:37 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Asthenia
Blindness Transient
Health
Professional
Metadate Cd Capsules
20 Mg
Duration
Role
Hypoaesthesia
Muscle Disorder
(Methylphenidate
Hydrochloride)
PS
Geodon (Ziprasidone
Hydrochloride)
SS
ORAL
60 MG (20 MG,
Paraesthesia
TID), PO
Viral Infection
Vision Blurred
LOW DOSE
(DAILY)
Effexor (Venlafaxine
Hydrochloride)
Wellbutrin- Slow
Release (Bupropion
Hydrochloride)
C
C
Date:01/31/03ISR Number: 4051188-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE03023
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Fibrinogen
Decreased
Coagulation Factor
Decreased
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
20MG/DAY,
Coagulopathy
ORAL
Prothrombin Time Abnormal
Prothrombin Time
Shortened
18-Aug-2005
Page: 333
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/31/03ISR Number: 4051693-2Report Type:Expedited (15-DaCompany Report #EMADSS2003000688
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Hypoglycaemia
Foreign
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
PS
Manufacturer
Route
ORAL
TABLE, ORAL
Date:02/03/03ISR Number: 4050301-4Report Type:Direct
Age:49 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 185808
Report Source
Product
Role
Manufacturer
Route
Ritalin 20mg
Novartis
PS
Novartis
ORAL
Product
Role
Manufacturer
Route
Methylphenidate
PS
Manufacturer
Route
Duration
Depression
Drug Effect Decreased
20 MG 2X A
Fatigue
DAY ORAL
Pharmaceutical Product
Complaint
Date:02/05/03ISR Number: 4052103-1Report Type:Direct
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 186007
Report Source
Duration
Abnormal Behaviour
20 MG AM NOON
Drug Ineffective
4 PM
Pharmaceutical Product
Complaint
Date:02/07/03ISR Number: 4054405-1Report Type:Expedited (15-DaCompany Report #03-00182
Age:42 YR
Gender:
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Completed Suicide
Literature
Methylphenidate
PS
Duration
Intentional Misuse
Health
Professional
Other
Bupropion
C
Date:02/07/03ISR Number: 4054409-9Report Type:Expedited (15-DaCompany Report #03-00181
Age:42 YR
Gender:
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Overdose
Literature
Health
Professional
Other
Methylphenidate
Bupropion
PS
C
Duration
Date:02/07/03ISR Number: 4054470-1Report Type:Expedited (15-DaCompany Report #03-00120
Age:41 YR
Gender:Female
I/FU:I
Outcome
Death
18-Aug-2005
Page: 334
PT
Agitation
Coma
Condition Aggravated
Drug Abuser
Intentional Misuse
Oxygen Saturation
Decreased
Pulmonary Oedema
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Respiratory Disorder
Snoring
Dose
Report Source
Product
Role
Literature
Health
Professional
Other
Methylphenidate
Methadone
Cocaine (Crack)
PS
C
C
Manufacturer
Route
Manufacturer
Route
Duration
Date:02/10/03ISR Number: 4054838-3Report Type:Direct
Age:11 YR
Gender:Male
I/FU:I
Outcome
PT
Dose
Duration
Other
Hallucination, Visual
18-36MGM ORAL 5
DAY
Insomnia
Sleep Disorder
Company Report #CTU 186336
Report Source
Product
Role
Concerta (Ritalin)
PS
ORAL
Date:02/10/03ISR Number: 4054843-7Report Type:Expedited (15-DaCompany Report #PHNR2003AU00498
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Anxiety
Bronchospasm
Foreign
Consumer
Other
Ritalin La
(Methylphenidate
Hydrochloride)
Extended Release
Capsules
PS
Lomotil
(Diphenoxylate
Hydrochloride)
C
Manufacturer
Route
Duration
ORAL
40 MG, QD,
ORAL
Date:02/11/03ISR Number: 4055961-XReport Type:Expedited (15-DaCompany Report #PHEH2003US00938
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Hospitalization Initial or Prolonged
Duodenal Ulcer
Gastric Ulcer
Gastrooesophageal Reflux
Disease
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
40 MG, QD
Hiatus Hernia
Oesophageal Ulcer
Oesophagitis
Date:02/11/03ISR Number: 4056196-7Report Type:Expedited (15-DaCompany Report #2003004699
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
100 MG
PT
Report Source
Product
Role
Manufacturer
Route
Convulsion
Consumer
Zoloft (Sertraline)
PS
ORAL
Methylphenidate
Hydrochloride
SS
ORAL
Duration
Drug Interaction
(DAILY) ,
Dysphonia
ORAL
Eye Pain
Keratoconjunctivitis
20 MG
Sicca
(DAILY), ORAL
Sleep Apnoea Syndrome
Somnolence
Visual Disturbance
18-Aug-2005
Page: 335
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/11/03ISR Number: 4056724-1Report Type:Expedited (15-DaCompany Report #PHNU2003DE00644
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Nodal Arrhythmia
Palpitations
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
15 MG/DAY,
ORAL
Date:02/12/03ISR Number: 4057752-2Report Type:Expedited (15-DaCompany Report #NSADSS2003005851
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
Required
Intervention to
54 MG, 1 IN 1
Prevent Permanent
DAY (S), ORAL
Impairment/Damage
PT
Report Source
Product
Role
Cardiac Arrest
Ventricular Arrhythmia
Health
Professional
Concerta (54 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Remeron
(Mirtazapine)
C
Manufacturer
Route
ORAL
Date:02/12/03ISR Number: 4057753-4Report Type:Expedited (15-DaCompany Report #NSADSS2003005850
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Lymphatic System Neoplasm
Consumer
Concerta (54 Mg
Sustained Frelease
Tablet)
(Methylphenidate
Hydrochloride)
PS
54 MG, 1 IN 1
DAY (S), ORAL
Celexa (Citalopram
Manufacturer
Route
ORAL
Hydrobromide)
C
Date:02/13/03ISR Number: 4057528-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE00479
Age:
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Drug Intolerance
Persecutory Delusion
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Zoloft (Sertraline
Hydrochloride)
Film-Coated Tablet
C
Manufacturer
Route
Duration
ORAL
ORAL
Date:02/13/03ISR Number: 4057935-1Report Type:Expedited (15-DaCompany Report #NSADSS2003006196
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Dystonia
Health
Professional
Company
Representative
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Risperdal
(Risperidone)
C
ORAL
18-Aug-2005
Page: 336
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Depakote (Valproate
Semisodium)
Celexa (Citalopram
Hydrobromide)
Buspar (Buspirone
Hydrochloride)
Benadryl
(Diphenhydramine
Hydrochloride)
C
C
C
C
Date:02/13/03ISR Number: 4057936-3Report Type:Expedited (15-DaCompany Report #NSADSS2003006182
Age:17 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Abnormal Behaviour
Agitation
Consumer
Concerta
Role
(Methylphenidate)
PS
Prozac
(Fluoxetine
Hydrochloride)
C
Manufacturer
Route
ORAL
108 MG, 1 IN
1 DAY (S),
ORAL; SEE
IMAGE
Date:02/13/03ISR Number: 4057967-3Report Type:Expedited (15-DaCompany Report #PHEH2003US00938
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Duodenal Ulcer
Gastric Ulcer
Gastrooesophageal Reflux
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
PS
40 MG, QD
Disease
Hiatus Hernia
Oesophageal Ulcer
Oesophagitis
Manufacturer
Route
Date:02/13/03ISR Number: 4058100-4Report Type:Expedited (15-DaCompany Report #PHEH2002US09142
Age:17 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Abdominal Pain Upper
Cardiac Disorder
Dilatation Ventricular
Gilbert'S Syndrome
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
10 MG, TID,
Oesophageal Disorder
ORAL
Syncope
Ventricular Arrhythmia
Date:02/14/03ISR Number: 4056667-3Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Generic
Methylphenidate
PS
Duration
Drug Ineffective
Irritability
PRIOR TO
ESTABLISH
WITH ME
18-Aug-2005
Page: 337
Company Report #CTU 186752
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/19/03ISR Number: 4059710-0Report Type:Expedited (15-DaCompany Report #EMADSS2003001178
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Body Temperature
Increased
Confusional State
Hyperhidrosis
Foreign
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
54 MG, DAILY,
Mydriasis
ORAL
Overdose
Tachycardia
Date:02/19/03ISR Number: 4059781-1Report Type:Expedited (15-DaCompany Report #NSADSS2003005978
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Elevated Mood
Hallucination
Headache
Pyrexia
Rash
Consumer
Concerta (36 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
36, ORAL
Date:02/20/03ISR Number: 4058069-2Report Type:Direct
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18MG PO QD
PT
Report Source
Product
Role
Concerta
PS
Manufacturer
Route
Duration
Tremor
Date:02/20/03ISR Number: 4058202-2Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Other
Company Report #CTU 186996
PT
ORAL
Company Report #USP 55449
Report Source
Product
Role
Manufacturer
Methylin
PS
Mallinckrodt Pharm
Duration
Medication Error
Route
Methylin
Date:02/20/03ISR Number: 4058601-9Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
10MG IN AM
PT
SS
Mallinckrodt Pharm
Product
Role
Manufacturer
Route
Methylphenidate
PS
Manufacturer
Route
Company Report #CTU 186908
Report Source
Duration
Drug Ineffective
Pharmaceutical Product
Complaint
Date:02/20/03ISR Number: 4060732-4Report Type:Expedited (15-DaCompany Report #2002069463
Age:
Gender:Female
I/FU:F
Outcome
Dose
Duration
Other
40 MG (BID),
PT
Report Source
Product
Role
Asthenia
Consumer
Geodon (Ziprasidone)
PS
ORAL
Blindness Transient
Health
Blindness Unilateral
Hypoaesthesia
Professional
Methylphenidate
Hydrochloride
SS
ORAL
ORAL
60 MG (TID),
Sensory Disturbance
ORAL
Vision Blurred
18-Aug-2005
Page: 338
11:49 AM
Venlafaxine
Hydrochloride
Bupropion
Hydrochloride
C
C
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/21/03ISR Number: 4062207-5Report Type:Expedited (15-DaCompany Report #EMADSS2003000688
Age:16 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abnormal Behaviour
Emotional Disorder
Hypoglycaemia
Foreign
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
ORAL
Date:02/24/03ISR Number: 4064903-2Report Type:Expedited (15-DaCompany Report #NSADSS2003007333
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Hallucination
Ill-Defined Disorder
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Promethazine With
Codeine
C
Manufacturer
Route
ORAL
SEE IMAGE
Date:02/25/03ISR Number: 4065360-2Report Type:Expedited (15-DaCompany Report #PHBS2003CA01572
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Neurofibromatosis
Skin Lesion
Foreign
Health
Professional
Other
Ritalin-Sr
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:02/26/03ISR Number: 4066897-2Report Type:Expedited (15-DaCompany Report #PHFR2003IE00874
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Epistaxis
Foreign
Ritaline(Methylpheni
Duration
Role
Manufacturer
Route
Consumer
Other
date Hydrochloride)
Tablet
PS
ORAL
7.5 TID,
5MG/EVE, ORAL
Date:02/27/03ISR Number: 4066928-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB04247
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Systemic Lupus
Erythematosus
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Unknown
PS
Other
Melatonin
(Melatonin)
C
Manufacturer
Route
Duration
ORAL
ORAL
Date:02/27/03ISR Number: 4067855-4Report Type:Expedited (15-DaCompany Report #NSADSS2003006196
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Drug Ineffective
Drug Interaction
Dystonia
Health
Professional
Company
Concerta
(Methyphenidate
Hydrochloride)
PS
Tic
Representative
54 MG TO 126
MG02
Risperdal
18-Aug-2005
Page: 339
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
(Risperidone)
Celexa
(Citalopram
Hydrobromide)
Strattera
(Atomoxetine)
Depakote
(Valproate
Semisodium)
Buspar
(Buspirone
Hydrochloride)
Benadryl
(Diphenhydramine
Hydrochloride)
SS
SS
SS
C
C
C
Date:02/27/03ISR Number: 4068352-2Report Type:Expedited (15-DaCompany Report #NSADSS2003006196
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Drug Ineffective
Drug Interaction
Dystonia
Health
Professional
Company
Risperdal
(Unspecified)
(Risperidone)
PS
Tic
Representative
Concerta *Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
SS
Strattera
(Atomoxetine)
SS
Celexa (Citalopram
Hydrobromide)
SS
UNK
54 MG TO 126
MG
UNK
UNK
Depakote (Valproate
Semisodium)
Buspar (Buspirone
Hydrochloride)
Benadryl
(Diphenhydramine
Hydrochloride)
C
C
C
Manufacturer
Route
Date:02/28/03ISR Number: 4067644-0Report Type:Expedited (15-DaCompany Report #EMADSS2003000793
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hallucinations, Mixed
Vision Blurred
Foreign
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Anaesthetics
(Anaesthetics)
C
SEE IMAGE
Date:02/28/03ISR Number: 4068092-XReport Type:Expedited (15-DaCompany Report #HQWYE482319FEB03
Age:75 YR
Gender:Female
I/FU:I
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 340
Manufacturer
Route
Duration
11:49 AM
PT
Drug Interaction
Flushing
Hypotension
Malaise
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Medication Error
Myalgia
Nausea
Dose
Report Source
Product
Role
Manufacturer
Route
Health
Professional
Efexor (Venlafaxine
Hydrochloride,
Tablet)
PS
ORAL
Aurorix
(Moclobemide)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
Unspecified Herbal
Product
SS
ORAL
Tranxilium
(Clorazepate
Dipotassium)
C
Duration
Serotonin Syndrome
Vertigo
Vomiting
37.5 MG 1X
PER 1 DAY,
ORAL
1
DAY
450 MG 1X PER
1 DAY, ORAL
20 MG 1X PER
1 DAY, ORAL
20 ML 1X PER
1 DAY, ORAL
1
DAY
Date:03/03/03ISR Number: 4069057-4Report Type:Expedited (15-DaCompany Report #EMADSS2003001588
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hallucination, Visual
Foreign
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
36 MG, 1 IN 1
DAY(S), ORAL
Ritalin
ORAL
(Methylphenidate
Hydrochloride)
SS
ORAL
10 MG, DAILY,
ORAL
Date:03/03/03ISR Number: 4069153-1Report Type:Expedited (15-DaCompany Report #NSADSS2003009091
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hallucinations, Mixed
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:03/03/03ISR Number: 4069810-7Report Type:Expedited (15-DaCompany Report #M01304-2002
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization 30 MG DAILY
Initial or Prolonged
54 MG DAILY
PT
Report Source
Product
Role
Biopsy Bone Marrow
Health
Remeron
PS
Abnormal
Professional
Concerta
SS
Pancytopenia
Pyrexia
18-Aug-2005
Page: 341
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/03/03ISR Number: 4084931-0Report Type:Periodic
Age:5 YR
Gender:
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Company Report #NSADSS2002041857
PT
Report Source
Product
Role
Vomiting
Health
Professional
Company
Representative
Concerta (18 Mg
Sustained Release
Tablet)
(Methylphenidate)
PS
Manufacturer
Route
ORAL
18 MG, ORAL
Date:03/03/03ISR Number: 4084933-4Report Type:Periodic
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #NSADSS2003002006
PT
Report Source
Product
Role
Growth Retardation
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
54 MG, 1 IN 1
DAY (S), ORAL
Date:03/04/03ISR Number: 4066219-7Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #USP 55554
Report Source
Product
Role
Manufacturer
Metadate Er
PS
Celltech
Metadate Cd
SS
Celltech
Duration
Medication Error
EXTENDED
RELEASE
EXTENDED
RELEASE
Date:03/04/03ISR Number: 4071093-9Report Type:Expedited (15-DaCompany Report #PHBS2003CH02114
Age:
Gender:Female
I/FU:I
Route
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Flushing
Hypotension
Malaise
Myalgia
Nausea
Vomiting
Foreign
Health
Professional
Other
Ritalin
(Methylphenidate
Hydrochloride)
Efexor (Venlfaxine
Hydrochloride)
Elisir Roborans Pm
(Magnesium-,Calcium,Natriumglycerophosp
horicum; Strychnin
Nitrate)
Aurorix
(Moclobemide)
Tranxilium
(Clorazepate
Dipotassium)
Role
Manufacturer
Route
Manufacturer
Route
PS
SS
SS
C
C
Date:03/04/03ISR Number: 4071095-2Report Type:Expedited (15-DaCompany Report #PHBS2003SE02090
Age:18 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 342
PT
Report Source
Product
Role
Angioneurotic Oedema
Foreign
Health
Professional
Other
Ritalin
(Methlphenidate
Hydrochloride)
PS
Duration
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/05/03ISR Number: 4071224-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE01089
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hypothyroidism
Thyroid Atrophy
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
10
Other
MG-0-5MG/DAY,
ORAL
Date:03/07/03ISR Number: 4072728-7Report Type:Expedited (15-DaCompany Report #PHEH2003US01685
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Obsessive-Compulsive
Disorder
Tourette'S Disorder
Consumer
Ritalin(Methylphenid
ate Hydrochloride)
Concerta
(Methylphenidate
Hydrochloride)
Role
Manufacturer
Route
Manufacturer
Route
Duration
PS
SS
Date:03/10/03ISR Number: 4073121-3Report Type:Expedited (15-DaCompany Report #NSADSS2003010350
Age:7 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Anorexia
Depression
Self-Induced Vomiting
Consumer
Concerta (54 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
54MG, 1 IN 1
DAY (S), ORAL
Date:03/10/03ISR Number: 4073522-3Report Type:Expedited (15-DaCompany Report #NSADSS2003009649
Age:5 YR
Gender:Male
I/FU:I
ORAL
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Depression
Suicidal Ideation
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Date:03/10/03ISR Number: 4073527-2Report Type:Expedited (15-DaCompany Report #NSADSS2003009651
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Idiopathic
Thrombocytopenic Purpura
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Duration
ORAL
ORAL
Date:03/10/03ISR Number: 4074467-5Report Type:Expedited (15-DaCompany Report #EMADSS2003001829
Age:7 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
ORAL
18-Aug-2005
Page: 343
11:49 AM
PT
Report Source
Product
Role
Dehydration
Haematemesis
Foreign
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/12/03ISR Number: 4072011-XReport Type:Direct
Age:73 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
15 MG BID
PT
Company Report #CTU 188576
Report Source
Diarrhoea
Febrile Neutropenia
Product
Role
D-Methylphenidate 5
Mg Tabs Biologics
PS
Placebo 5 Mg Tabs
Biologics
SS
Manufacturer
Route
ORAL
Nausea
ORAL
Vomiting
Date:03/12/03ISR Number: 4072071-6Report Type:Direct
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Concerta
Concerta
PS
SS
Sandoz Alza
Product
Role
Manufacturer
Route
Ritalin Sr 20mg Qd
PS
Manufacturer
Route
Duration
Medication Error
Date:03/13/03ISR Number: 4074031-8Report Type:Direct
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Company Report #USP 55494
PT
Company Report #CTU 188661
Report Source
Duration
Disturbance In Attention
20 1 QD
Date:03/13/03ISR Number: 4076034-6Report Type:Expedited (15-DaCompany Report #PHEH2002US10433
Age:
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Leukocytoclastic
Vasculitis
Petechiae
Pharmaceutical Product
Consumer
Methylphenidate
(Methylphenidate
Hydrochloride)
Tablet
PS
Duration
10 MG, TID,
Complaint
ORAL
ORAL
Date:03/13/03ISR Number: 4076078-4Report Type:Expedited (15-DaCompany Report #PHBS2003NO02324
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hallucination, Visual
Foreign
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
PS
Concerta
C
Manufacturer
Route
Duration
ORAL
10 MG/DAY
Other
ORAL
Date:03/13/03ISR Number: 4076079-6Report Type:Expedited (15-DaCompany Report #PHNR2003AU00606
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
40 MG
18-Aug-2005
Page: 344
PT
Report Source
Product
Role
Hallucination
Foreign
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
PS
Duration
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/13/03ISR Number: 4076128-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE04262
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Impaired Healing
Peripheral Coldness
Peripheral Vascular
Foreign
Health
Professional
Ritalin-Sr(Methylphe
nid Hydrochloride)
Slow Release Tablet
PS
Disorder
Other
Manufacturer
Route
Duration
ORAL
20MG/DAY,
ORAL
Date:03/14/03ISR Number: 4074119-1Report Type:Direct
Age:48 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Required
Intervention to
1 TAB BID
Prevent Permanent
ORAL
Impairment/Damage
1 TAB BID
PT
Company Report #CTU 188714
Report Source
Blindness
Cataract
Product
Role
Manufacturer
Route
PS
Nova
ORAL
Ritalin 10 Mg Nova
SS
Nova
ORAL
Synthroid
Climara
Paxil
C
C
C
Manufacturer
Route
Trileptal
Nova
300 Mg
ORAL
Date:03/17/03ISR Number: 4077432-7Report Type:Expedited (15-DaCompany Report #NSADSS2003011394
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
54 MG, DAILY,
ORAL
PT
Report Source
Product
Role
Pancytopenia
Pyrexia
Health
Professional
Concerta (54 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
ORAL
Remeron
(Mirtazapine)
SS
ORAL
30 MG, DAILY,
ORAL
Date:03/17/03ISR Number: 4077435-2Report Type:Expedited (15-DaCompany Report #NSADSS2002038813
Age:21 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Libido Decreased
Testis Cancer
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
54 MG, 1 IN 1
DAY(S), ORAL
Date:03/17/03ISR Number: 4077569-2Report Type:Expedited (15-DaCompany Report #EMADSS2003002050
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG, 1 IN 1
DAILY, ORAL;
36 MG, 1 IN
1 DAILY, ORAL
18-Aug-2005
Page: 345
PT
Report Source
Product
Role
Cerebrovascular Accident
Foreign
Health
Professional
Concerta (18 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Methylphenidate It
(Methylphenidate)
C
Date:03/17/03ISR Number: 4077575-8Report Type:Expedited (15-DaCompany Report #EMADSS2003001983
Age:5 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Blood Pressure Increased
Gastrointestinal
Infection
Medication Error
Pyrexia
Foreign
Health
Professional
Concerta (36 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
36 MG, 1 IN 1
DAILY, ORAL
Date:03/18/03ISR Number: 4078062-3Report Type:Expedited (15-DaCompany Report #NSADSS2003011185
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Cerebral Cyst
Sinusitis
Upper Respiratory Tract
Infection
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Clonidine
(Clonidine)
C
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
DAILY, ORAL
Date:03/19/03ISR Number: 4078137-9Report Type:Direct
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
20MG TID PO
PT
Company Report #CTU 189122
Report Source
Product
Role
Manufacturer
Route
Ritalin
(Methlphenidate)
20mg Geneva
PS
Geneva
ORAL
Duration
Drug Effect Decreased
Educational Problem
Pharmaceutical Product
Complaint
Date:03/19/03ISR Number: 4078871-0Report Type:Expedited (15-DaCompany Report #NSADSS2003012338
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Chest Pain
Fall
Gait Disturbance
Loss Of Consciousness
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Clonidine
C
54 MG, 1 IN 1
Medication Error
DAY(S), ORAL;
72 MG, 1 IN 1
TIME(S)
Date:03/20/03ISR Number: 4080450-6Report Type:Expedited (15-DaCompany Report #NSADSS2002038993
Age:15 YR
Gender:Male
I/FU:F
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 346
Manufacturer
Route
Duration
11:49 AM
PT
Alanine Aminotransferase
Increased
Aspartate
Aminotransferase
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Increased
Pancreatitis
Dose
Report Source
Product
Role
Health
Professional
Concerta (36 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:03/20/03ISR Number: 4080739-0Report Type:Expedited (15-DaCompany Report #PHBS2003NL02778
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Chest Pain
Dyspnoea
Foreign
Consumer
Other
Ritalin(Methylphenid
ate Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
30 MG/DAY,
ORAL
Date:03/20/03ISR Number: 4080820-6Report Type:Expedited (15-DaCompany Report #EMADSS2003002190
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Apathy
Depressed Mood
Sedation
Social Avoidant Behaviour
Foreign
Health
Professional
Concerta (54 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
54 MG, DAILY,
ORAL
Date:03/25/03ISR Number: 4080170-8Report Type:Direct
Age:
Gender:Male
I/FU:I
Company Report #CTU 189407
ORAL
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Methylphenidate 5mg
Geneva Ndc
00781-8841-01
PS
Geneva
ORAL
Tenex
C
Manufacturer
Route
Duration
Face Oedema
Feeling Hot
Flushing
5MG PO Q AM
Rash
AND QHS
Urticaria
Date:03/26/03ISR Number: 4084114-4Report Type:Expedited (15-DaCompany Report #EMADSS2003002050
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Cerebrovascular Accident
Haemorrhage Intracranial
Foreign
Health
Professional
Concerta (18 Mg
Sustained Release
Tablet )
(Methylphenidate
Hydrochloride)
PS
Mehylphenidate Ir
(Methylphenidate)
C
SEE IMAGE
18-Aug-2005
Page: 347
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/28/03ISR Number: 4080241-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12217170
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
50-100 mg
PT
Report Source
Product
Role
Manufacturer
Route
Alanine Aminotransferase
Trazodone Hcl Tabs
PS
Apothecon
ORAL
Increased
Aspartate
Aminotransferase
Increased
Blood Triglycerides
Abnormal
Epistaxis
Gamma-Glutamyltransferase
Increased
Lipids Increased
Concerta Xl
Isotretinoin
SS
C
Duration
Date:03/28/03ISR Number: 4083381-0Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
5MG Q AM AND
PT
ORAL
Company Report #CTU 189700
Report Source
Drug Effect Decreased
Product
Role
Methylphenidate Hcl
PS
Methylphenidate Hcl
SS
Manufacturer
Route
Manufacturer
Route
Pharmaceutical Product
NOON
Complaint
20MG Q AM AND
NOON
Date:03/28/03ISR Number: 4083568-7Report Type:Periodic
Age:18 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Required
40 MG QD PO
Intervention to
36 MG QD PO
Prevent Permanent
Impairment/Damage
Company Report #2002UW14531
PT
Report Source
Product
Role
Bradycardia
Distributor
Zestril
PS
ORAL
Concerta
SS
ORAL
Syncope
Date:03/28/03ISR Number: 4083684-XReport Type:Direct
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
PT
Company Report #CTU 189715
Report Source
Abnormal Behaviour
Crying
Physical Assault
Psychiatric Symptom
Skin Discolouration
Weight Decreased
Product
Role
Depakote 250 Mg X6
Ritilan 20mg X3
PS
SS
Manufacturer
Route
Manufacturer
Route
Date:03/28/03ISR Number: 4086792-2Report Type:Expedited (15-DaCompany Report #EMADSS2003001829
Age:7 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Dehydration
Dyspraxia
Haematemesis
Insomnia
Learning Disorder
Foreign
Health
Professional
Concerta(18 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
18 MG, 1 IN 1
DAY(S), ORAL
Melatonin
(Melatonin)
Vallergen
18-Aug-2005
Page: 348
11:49 AM
C
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
(Alimemazine
Tartrate)
Date:03/31/03ISR Number: 4083947-8Report Type:Direct
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PO TID
PT
C
Company Report #CTU 189823
Report Source
Product
Role
Methylphenidate 20mg
PS
Manufacturer
Route
Duration
Drug Ineffective
ORAL
Pharmaceutical Product
[SEVERAL
Complaint
MONTHS]
Date:03/31/03ISR Number: 4087342-7Report Type:Expedited (15-DaCompany Report #EMADSS2003002413
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Body Temperature
Increased
Disorientation
Dysarthria
Foreign
Health
Professional
Concerta (Sustained
Release Tablets)
(Methylphenidate
Hydrochloride)
PS
Clonidine
(Clonidine)
C
Manufacturer
Route
Duration
ORAL
54 MG , ORAL
Facial Paresis
Headache
Date:03/31/03ISR Number: 4087520-7Report Type:Expedited (15-DaCompany Report #PHBS2003CA01572
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
20; 40 MG,
QD, ORAL
PT
Report Source
Product
Role
Neurofibromatosis
Foreign
Health
Professional
Other
Ritalin-Sr
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
Date:03/31/03ISR Number: 4087553-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE03759
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Thyroid Stimulating
Hormone Increased
Thyroid Adenoma
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
20 MG, QD,
Other
ORAL
Date:03/31/03ISR Number: 4087609-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE01337
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
365
PT
Report Source
Product
Role
Activated Partial
Thromboplastin Time
Prolonged
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Antiphospholipid
Antibodies Positive
Von Willebrand'S Disease
Other
Duration
DAY
18-Aug-2005
Page: 349
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/02/03ISR Number: 4088103-5Report Type:Expedited (15-DaCompany Report #CEL-2003-00606-ROC
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
General Physical Health
Deterioration
Tic
Health
Professional
Metadate Cd
(Methylphenidate
Hydrochloride)
PS
Depakote (Valproate
Semisodium)
Ssri (Ssri)
C
C
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
20 MG (20 MG,
QD), UNK
Date:04/04/03ISR Number: 4089913-0Report Type:Expedited (15-DaCompany Report #PHEH2003US02507
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Cardiac Arrest
Consumer
Ritalin
(Methylphenidate
Hydrochloride)
PS
Duration
Date:04/04/03ISR Number: 4090090-0Report Type:Expedited (15-DaCompany Report #PHBS2003UY03435
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Oral Infection
Oral Soft Tissue Disorder
Viral Infection
Foreign
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
PS
ORAL
1 MG/KG/DAY,
Other
ORAL
Date:04/04/03ISR Number: 4090124-3Report Type:Expedited (15-DaCompany Report #CEL-2003-00586-ROC (0)
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Other
Epilepsy
Health
Professional
Company
Representative
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
ORAL
40 MG (40 MG,
Q AM), PO
Date:04/04/03ISR Number: 4090814-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE00892
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Electrocardiogram Qt
Corrected Interval
Prolonged
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
30 MG/DAY,
ORAL
Date:04/04/03ISR Number: 4091005-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB01311
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
20MG/DAY;
18-Aug-2005
Page: 350
PT
Report Source
Product
Role
Raynaud'S Phenomenon
Tachycardia
Foreign
Health
Professional
Other
Ritalin-Sr
(Methylphenidate
Hydrochloride) Slow
Release Tablet
PS
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
40MG/DAY :
ORAL
74
DAY
Date:04/07/03ISR Number: 4093384-8Report Type:Expedited (15-DaCompany Report #2003-03-2806
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
SUBCUTANEOUS
PT
Report Source
Product
Role
Adrenal Insufficiency
Deafness Neurosensory
Intracranial Pressure
Increased
Foreign
Health
Professional
Other
Viraferonpeg (Peg
Interferon Alfa-2b
Recombinant)
Viraferon
(Interferon Alfa-2b)
PS
Ritalin Tablets
SS
Manufacturer
Route
SS
SUBCUTANEOUS
ORAL
ORAL
Date:04/07/03ISR Number: 4093386-1Report Type:Expedited (15-DaCompany Report #2003-03-2595
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
PT
Adrenal Insufficiency
Intracranial Pressure
SUBCUTANEOUS
Increased
SUBCUTANEOUS
Report Source
Product
Role
Foreign
Health
Viraferon
(Interferon Alfa-2b)
PS
Professional
Ritalin Tablets
SS
Manufacturer
Route
ORAL
ORAL
Other
Date:04/09/03ISR Number: 4092483-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE03908
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Disturbance In Attention
Fatigue
Visual Acuity Reduced
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
10-15 MG/DAY,
Other
ORAL
Manufacturer
Route
Duration
ORAL
Date:04/11/03ISR Number: 4094191-2Report Type:Expedited (15-DaCompany Report #NSADSS2003016574
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Anger
Health
Professional
Company
Representative
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Strattera/Atomoxetin
e
C
Manufacturer
Route
Duration
ORAL
72 MG, 1 IN 1
DAILY; ORAL;
36 MG, 1 IN 1
DAY(S); ORAL
Date:04/15/03ISR Number: 4095884-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE01527
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Cerebral Haemorrhage
Coagulopathy
Haemorrhage
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
0.5 DF QD
ORAL
Ritalin-Sr
(Methylphenidate
18-Aug-2005
Page: 351
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hydrochloride) Slow
Release Tablet
SS
ORAL
1 DF QD ORAL
Date:04/15/03ISR Number: 4096014-4Report Type:Expedited (15-DaCompany Report #PHBS2003JP03691
Age:36 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Overdose
Renal Failure Acute
Rhabdomyolysis
Foreign
Health
Professional
Other
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
50 TABLETS,
ONCE/SINGLE,
ORAL
Date:04/18/03ISR Number: 4098819-2Report Type:Expedited (15-DaCompany Report #NSADSS2003008050
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Headache
Pyrexia
Thrombocythaemia
Health
Professional
Company
Representative
Concerta (18 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
18, 1 IN 1
DAY(S), ORAL
Date:04/18/03ISR Number: 4098846-5Report Type:Expedited (15-DaCompany Report #PHRM2003FR01240
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
ORAL
PT
Report Source
Product
Role
Adrenal Insufficiency
Headache
Hearing Impaired
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
SUBCUTANEOUS
Intracranial Pressure
Increased
Vision Blurred
SUBCUTANEOUS
Other
Viraferon(Interferon
Alfa-2b) Solution
For Injection
SS
Date:04/21/03ISR Number: 4093998-5Report Type:Expedited (15-DaCompany Report #CH-ROCHE-335934
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Condition Aggravated
Electrocardiogram Qt
Prolonged
Hypomagnesaemia
Loss Of Consciousness
Consumer
Valium
Ketalgine
(Switzerland)
Ketalgine
(Switzerland)
PS
Roche
ORAL
SS
ORAL
SS
ORAL
Risperdal
Ritalin
SS
SS
ORAL
Ritalin
SS
Cocaine
SS
Ilomedin
SS
Mst
Seresta
Liquemin
C
C
C
DOSAGE
Syncope
DECREASED IN
Torsade De Pointes
RESPONSE TO
EVENTS.
UNKNOWN
UNKNOWN
UNKNOWN
INTRAVENOUS
INTRAVENOUS
AND 25000 U.
18-Aug-2005
Page: 352
30
STRENGH: 5000
29
DAY
11:49 AM
DAY
ORAL
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/21/03ISR Number: 4099224-5Report Type:Expedited (15-DaCompany Report #EMADSS2003003151
Age:37 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
2 MG, DAILY,
PT
Report Source
Product
Role
Manufacturer
Drug Abuser
Injection Site Pain
Loss Of Consciousness
Foreign
Health
Professional
Risperdal (2 Mg
Tablet)
(Risperidone)
PS
ORAL
Ketalgin (Methadone
Hydrochloride)
SS
ORAL
Route
Medication Error
ORAL
Peripheral Ischaemia
Torsade De Pointes
160 MG,
Ventricular Tachycardia
DAILY, ORAL
INTRA-ARTERIAL
Kokain (Cocaine)
Ritalin
(Methylphenidate
Hydrochloride)
SS
Valium (Diazepam)
SS
Ilomedin (Iloprost)
SS
Seresta (Oxazepam)
Mst (Morphine
Sulfate)
Liquemin (Heparin)
C
SS
ARTER
ORAL
20 MG, DAILY,
ORAL
INTRAVENOUS
50 MG, DAILY,
IV
C
C
Date:04/21/03ISR Number: 4099606-1Report Type:Expedited (15-DaCompany Report #PHRM2003FR01253
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Conduction Disorder
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
Other
ORAL
Date:04/22/03ISR Number: 4099931-4Report Type:Expedited (15-DaCompany Report #EMADSS2003003300
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Pseudo Lymphoma
Skin Disorder
Foreign
Health
Professional
Concerta Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10
ORAL
WK
Date:04/22/03ISR Number: 4100751-2Report Type:Expedited (15-DaCompany Report #CEL-2003-00606-ROC
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Tic
Health
Professional
Metadate Cd
Role
(Methylphenidate
Hydrochloride)
PS
Depakote (Valproate
Semisodium)
Ssri
C
C
20 MG (20 MG,
QD);
40 MG
(20 MG, QD)
18-Aug-2005
Page: 353
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/23/03ISR Number: 4101649-6Report Type:Expedited (15-DaCompany Report #CEL-2003-00919-ROC
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Headache
Petit Mal Epilepsy
Health
Professional
Metadate
(Formulation
Unspecified)
Methylphenidate
Hydrochloride)
Strattera
Celexa (Citalopram
Hydrobromide)
Role
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
PS
SS
C
Date:04/23/03ISR Number: 4101676-9Report Type:Expedited (15-DaCompany Report #CEL-2003-00606-ROC(2)
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Anxiety
Tic
Health
Professional
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Depakote (Valproate
Semisodium)
Ssri (Ssri)
C
C
SEE IMAGE
Date:04/24/03ISR Number: 4102312-8Report Type:Expedited (15-DaCompany Report #NSADSS2003018777
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
TRANSDERMAL
PT
Report Source
Product
Role
Other
Duragesic ( 100 Mcg/
Hr Patch) (Fentanyl)
PS
Duration
Brain Oedema
Drug Abuser
100 MCG/H,
Endocardial Disease
TRANSD
Haemorrhage
Overdose
Petechiae
Pleural Disorder
Pulmonary Congestion
Darvon
(Dextropropoxyphene
Hydrochloride)
Ritalin
(Methylphenidate
SS
Pulmonary Oedema
Respiratory Arrest
Toxicologic Test Abnormal
Hydrochloride)
Marijuana (Cannabis)
SS
SS
Date:04/24/03ISR Number: 4102482-1Report Type:Expedited (15-DaCompany Report #PHEH2003US03056
Age:19 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Glaucoma
Consumer
Ritalin(Methylphenid
ate Hydrochloride)
Unknown
PS
Manufacturer
Route
Duration
ORAL
20 MG, QD,
ORAL
Date:04/25/03ISR Number: 4097931-1Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Manufacturer
Ritalin Sr
Ritalin
PS
SS
Ciba
Ciba
Duration
Medication Error
18-Aug-2005
Page: 354
Company Report #USP 51470
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/25/03ISR Number: 4103211-8Report Type:Expedited (15-DaCompany Report #2003016398
Age:16 YR
Gender:
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Completed Suicide
Drug Level Increased
Literature
Health
Professional
Hydroxyzine
Hydrochloride
(Tablet)
(Hydroxyzine
Hydrochloride)
PS
ORAL
Amitriptyline
(Amitriptyline)
SS
ORAL
Methylphenidate
(Methylphenidate)
SS
ORAL
Nortriptyline
(Nortriptyline)
SS
ORAL
Duration
ORAL
ORAL
ORAL
ORAL
Date:04/28/03ISR Number: 4104145-5Report Type:Expedited (15-DaCompany Report #NSADSS2003018691
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Dizziness
Syncope
Vomiting
Health
Professional
Company
Representative
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:04/28/03ISR Number: 4104199-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE01648
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
25MG/DAY,
PT
Report Source
Product
Role
Circulatory Collapse
Ventricular Extrasystoles
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
ORAL
Date:04/28/03ISR Number: 4104233-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB04019
Age:
Gender:
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Allergic Granulomatous
Angiitis
Foreign
Health
Professional
Other
Methylphenidate
Hydrochloride
(Methylphenidate
Hydrochloride)
Unknown
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:04/28/03ISR Number: 4104488-5Report Type:Expedited (15-DaCompany Report #PHBS2003JP03109
Age:46 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Erythema
Ichthyosis Acquired
Pigmentation Disorder
Other
Anafranil(Clomiprami
ne Hydrochloride)
Tablet
PS
ORAL
Ritalin(Methylphenid
ate Hydrochloride)
SS
ORAL
Rohypnol
(Flunitrazepam)
C
Duration
10 MG/DAY,
Rash Papular
ORAL
Xerosis
20 MG/DAY,
ORAL
18-Aug-2005
Page: 355
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Serenzin
Reslin (Trazodone
Hydrochloride)
Ethyl Loflazepate
(Ethyl Loflazepate)
Miradol (Sulpiride)
C
C
C
C
Date:04/30/03ISR Number: 4104588-XReport Type:Expedited (15-DaCompany Report #US010793
Age:32 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Convulsion
Health
Professional
Actiq
Methadone
PS
SS
ORAL
Morphine Sulfate
SS
ORAL
Ritalin
SS
ORAL
Duration
100 MG TID
ORAL
60 MG PRN
ORAL
25 MG TID
ORAL
Date:04/30/03ISR Number: 4104590-8Report Type:Expedited (15-DaCompany Report #US010793
Age:33 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Convulsion
Depression
Health
Professional
Actiq
Provigil
PS
SS
ORAL
Provigil
SS
ORAL
Methadone
SS
ORAL
Duration
200 MG QAM
Somnolence
ORAL
100 MG QPM
ORAL
100 MG TID
ORAL
Morphine Sulfate
SS
ORAL
Ritalin
SS
ORAL
Effexor
SS
ORAL
Effexor
SS
ORAL
60 MG PRN
ORAL
25 MG TID
ORAL
150 MG QHS
ORAL
225 MG QHS
ORAL
Date:04/30/03ISR Number: 4105121-9Report Type:Expedited (15-DaCompany Report #A001-002-005498
Age:18 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Required
Intervention to
Prevent Permanent
10 MG, 1 IN 1
Impairment/Damage
D, PER ORAL
PT
Report Source
Product
Role
Asthenia
Nausea
Vomiting
Health
Professional
Aricept (Donepezil)
(Donepezil
Hydrochloride)
PS
ORAL
Ritalin Sr
(Methylphenidate
Hydrochloride)
SS
ORAL
Albuterol
(Salbutamol)
C
20 MG, ORAL;
40 MG, ORAL
11:49 AM
Route
White Blood Cell Count
Decreased
18-Aug-2005
Page: 356
Manufacturer
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/30/03ISR Number: 4105775-7Report Type:Expedited (15-DaCompany Report #CEL-2003-00925-ROC(0)
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Creatine
Phosphokinase
Monoplegia
Pain In Extremity
Health
Professional
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
20 MG (20 MG,
QAM SCHOOL
DAYS); PO/
APROXI. 1 1/2
WEEKS
Date:05/01/03ISR Number: 4106368-8Report Type:Expedited (15-DaCompany Report #NSADSS2003020304
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abnormal Behaviour
Aggression
Anxiety
Hallucination
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Paxil (Parozetine
Hydrochloride)
C
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Nightmare
Date:05/01/03ISR Number: 4106370-6Report Type:Expedited (15-DaCompany Report #NSADSS2003020199
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
ORAL
PT
Report Source
Product
Role
Accident
Drowning
Treatment Noncompliance
Consumer
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
Date:05/02/03ISR Number: 4107010-2Report Type:Expedited (15-DaCompany Report #PHBS2003CH03918
Age:36 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Disability
PT
Report Source
Product
Role
Arthralgia
Blood Magnesium Decreased
Drug Abuser
Electrocardiogram Qt
Foreign
Health
Professional
Other
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Extremity Necrosis
Finger Amputation
Ketalgin(Methadone
Hydrochloride)
SS
Gangrene
Intentional Misuse
Risperdal(Risperidon
e)
SS
Loss Of Consciousness
Valium(Diazepam)
SS
Urokinase(Urokinase)
SS
Ilomedin(Iloprost)
SS
Mst (Morphine
Sulfate)
Seresta (Oxazepam)
Liquemin (Heparin)
C
C
C
10 MG/DAY,
Prolonged
INJECTION NOS
160 MG/DAY
2 MG/DAY
20 MG/DAY
INTRAVENOUS
Medication Error
5000 IU,
Necrosis Ischaemic
INTRAVENOUS
Peripheral Ischaemia
INTRAVENOUS
50 MG,
Syncope
INTRAVENOUS
Torsade De Pointes
Ventricular Tachycardia
18-Aug-2005
Page: 357
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/07/03ISR Number: 4109224-4Report Type:Expedited (15-DaCompany Report #PHBS2003BE04237
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Increased Appetite
Weight Increased
Foreign
Health
Professional
Other
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:05/07/03ISR Number: 4109247-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB01785
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Activated Partial
Thromboplastin Time
Prolonged
Foreign
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
PS
Contusion
Other
Manufacturer
Route
Duration
ORAL
ORAL
Date:05/07/03ISR Number: 4109719-3Report Type:Expedited (15-DaCompany Report #NSADSS2003021341
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Headache
Loss Of Consciousness
Ventricular Extrasystoles
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
SEE IMAGE
Motrin (Ibuprofen)
Tylenol
(Paracetamol)
Date:05/09/03ISR Number: 4110831-3Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Duration
C
C
Company Report #
Report Source
Product
Role
Manufacturer
Route
Medication Error
Date:05/12/03ISR Number: 4110935-5Report Type:Direct
Age:8.5 YR Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Metadate Er 20 Mg
PS
Company Report #CTU 192758
Report Source
Product
Role
Ritalin 10mg
Methaphildate
PS
Manufacturer
Route
Duration
Abnormal Behaviour
Aggression
ORAL
10MG 3X ORAL
Depression
Emotional Disorder
Date:05/13/03ISR Number: 4111930-2Report Type:Expedited (15-DaCompany Report #NSADSS2003017198
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
72 MG, 1 IN 1
DAY (S), ORAL
18-Aug-2005
Page: 358
11:49 AM
PT
Report Source
Product
Role
Crying
Emotional Disorder
Hallucination, Tactile
Hallucination, Visual
Health
Professional
Concerta (36 Mg
Sustained Release
Tablet)
(Methyphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/15/03ISR Number: 4112929-2Report Type:Expedited (15-DaCompany Report #PHEH2003US03697
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
TRANSDERMAL
PT
Report Source
Product
Role
Other
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
Fentanyl(Fentanyl)
PS
SS
Dextropropoxyphene(D
extropropoxyphene)
Marijuana(Cannabis)
SS
SS
Manufacturer
Route
Manufacturer
Route
Duration
Brain Oedema
Endocardial Disease
Haemorrhage
Intentional Misuse
Medication Tampering
100 MCG/HR,
Petechiae
TRANSDERMAL
Pleural Haemorrhage
Pulmonary Congestion
Pulmonary Oedema
Respiratory Arrest
Toxicologic Test Abnormal
Date:05/15/03ISR Number: 4112974-7Report Type:Expedited (15-DaCompany Report #PHRM2003FR01240
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Adrenal Insufficiency
Hearing Impaired
Intracranial Pressure
Increased
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Viraferon
(Interferon Alfa-2b)
Solution For
Injection
SS
ORAL
ORAL
SUBCUTANEOUS
SUBCUTANEOUS
Date:05/15/03ISR Number: 4113342-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB01831
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Cardiac Arrest
Cardiac Disorder
Circulatory Collapse
Foreign
Health
Professional
Methylphenidate(Meth
ylphenidate
Hydrochloride)
Duration
Role
Manufacturer
Route
Electrocardiogram
Other
Unknown
PS
Ritalin-Sr(Methylphe
nidate
Hydrochloride)
Unknown
SS
ORAL
ORAL
Abnormal
Electrocardiogram
Repolarisation
Abnormality
20 MG/DAY
Myocardial Infarction
Ventricular Tachycardia
Date:05/19/03ISR Number: 4113174-7Report Type:Expedited (15-DaCompany Report #PHBS2003US04722
Age:48 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Back Pain
Confusional State
Disorientation
Drug Interaction
Literature
Health
Professional
Methylphenidate(Meth
ylphenidate
Hydrochloride)
Unknown
PS
Drug Withdrawal Syndrome
Grand Mal Convulsion
Venlafaxine(Venlafax
ine)
SS
Insomnia
Zolpidem(Zolpidem)
SS
10 MG, TID,
SEE IMAGE
10 MG, QHS,
Muscle Spasms
Nausea
Serotonin Syndrome
Somnolence
18-Aug-2005
Page: 359
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/19/03ISR Number: 4113272-8Report Type:Expedited (15-DaCompany Report #PHEH2003US03667
Age:22 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Convulsion
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
Effexor (Venlafaxine
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Duration
SS
Date:05/19/03ISR Number: 4115106-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE01648
Age:17 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
25 MG/DAY,
PT
Report Source
Product
Role
Syncope
Ventricular Extrasystoles
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
ORAL
Other
ORAL
Date:05/19/03ISR Number: 4115292-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE00993
Age:19 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Henoch-Schonlein Purpura
Leukopenia
Lymphopenia
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Other
Cipramil Film-Coated
Tablet
Fenistil
C
C
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:05/20/03ISR Number: 4115319-1Report Type:Expedited (15-DaCompany Report #NSADSS2003022622
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Other
Delirium
Mydriasis
Health
Professional
Concerta (36 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
ORAL
36 MG, 1 IN
12 DAY(S),
ORAL
Date:05/20/03ISR Number: 4115320-8Report Type:Expedited (15-DaCompany Report #NSADSS2003022997
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
27 MG, 1 IN 1
DAY(S), ORAL
18-Aug-2005
Page: 360
PT
Report Source
Product
Role
Agitation
Hallucination, Visual
Screaming
Health
Professional
Concerta (27 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/20/03ISR Number: 4115322-1Report Type:Expedited (15-DaCompany Report #NSADSS2003007333
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Hallucination
Malaise
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Promethazine With
Codeine
C
Manufacturer
Route
ORAL
SEE IMAGE
Date:05/20/03ISR Number: 4115324-5Report Type:Expedited (15-DaCompany Report #NSADSS2002046188
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Sudden Cardiac Death
Ventricular Tachycardia
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate)
PS
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:05/21/03ISR Number: 4115891-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB01961
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Leukaemia Monocytic
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
PS
Date:05/21/03ISR Number: 4118082-3Report Type:Direct
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
20MG AM, 15
PT
Route
Manufacturer
Route
Company Report #CTU 193534
Report Source
Product
Role
Ritalin
PS
Duration
Abnormal Behaviour
Manufacturer
Crying
AT NOON, 5 AT
Pharmaceutical Product
3PM
Complaint
Date:05/21/03ISR Number: 4118088-4Report Type:Direct
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18MG ORAL
PT
Company Report #CTU 193536
Report Source
Product
Role
Manufacturer
Route
Concerta 18mg Mcneil
PS
Mcneil
ORAL
Manufacturer
Route
Duration
Disturbance In Attention
Educational Problem
Pharmaceutical Product
Complaint
Date:05/22/03ISR Number: 4116744-5Report Type:Expedited (15-DaCompany Report #PHNR2003AU00498
Age:16 YR
Gender:Male
I/FU:F
Outcome
Dose
PT
Report Source
Product
Role
Anxiety
Bronchospasm
Foreign
Other
Ritalin La
(Methylphenidate
Hydrochloride)
Extended Release
Capsules
PS
Duration
40 MG,
QD,ORAL
Lomotil
18-Aug-2005
Page: 361
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
(Diphenoxylate
Hydrochloride)
C
Date:05/23/03ISR Number: 4116815-3Report Type:Expedited (15-DaCompany Report #EMADSS2003004081
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Eosinophilia
Foreign
Health
Professional
Concerta (36 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
DAY (S), ORAL
Date:05/23/03ISR Number: 4117123-7Report Type:Expedited (15-DaCompany Report #DSA_70099_2003
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
TRANSDERMAL
PT
Report Source
Product
Role
Darvon
Fentanyl
PS
SS
Ritalin
Marijuana
SS
SS
Manufacturer
Route
Manufacturer
Route
Duration
Brain Oedema
Haemorrhage
100 MCG/HR TD
Medication Error
Nervous System Disorder
VAR
Petechiae
Pleural Haemorrhage
Pulmonary Congestion
Pulmonary Oedema
Respiratory Arrest
Date:05/23/03ISR Number: 4117169-9Report Type:Expedited (15-DaCompany Report #NSADSS2003023571
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Neutrophil Count
Decreased
Health
Professional
Risperdal
(Unspecified)
Duration
Role
White Blood Cell Count
(Risperidone)
PS
ORAL
Concerta
(Methylphenidate
Hydrochloride)
SS
ORAL
1.5 MG,
Decreased
DAILY, ORAL
36 MG, 1 IN 1
DAY(S), ORAL
Date:05/27/03ISR Number: 4119141-1Report Type:Direct
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 193931
Report Source
Product
Role
Concerta 36 Mg And
54 Mg Separately
PS
Manufacturer
Route
Duration
Dysphemia
Painful Erection
ORAL
1 X DAY PO
Priapism
Date:05/28/03ISR Number: 4117845-8Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
27MG Q D
PT
Company Report #CTU 194075
Report Source
Product
Role
Concerta 27mg Qd
PS
Rifamipin
SS
Duration
Arthritis Infective
Hallucination
EXISTING
Headache
150MG TWO BID
Staphylococcal Infection
18-Aug-2005
Page: 362
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/28/03ISR Number: 4122691-5Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
Other
Company Report #NSADSS2003016575
PT
Report Source
Product
Role
Psychotic Disorder
Therapeutic Response
Increased
Health
Professional
Company
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
54 MG DAILY,
Representative
2 IN 1 DAILY,
ORAL
Date:05/28/03ISR Number: 4122769-6Report Type:Expedited (15-DaCompany Report #2003-03-2595
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
SUBCUTANEOUS
PT
Intracranial Pressure
Increased
SUBCUTANEOUS
Report Source
Product
Role
Foreign
Health
Viraferon
(Interferon Alfa-2b)
PS
Professional
Ritalin Tablets
SS
Manufacturer
Route
ORAL
ORAL
Other
Date:05/29/03ISR Number: 4120090-3Report Type:Expedited (15-DaCompany Report #PHBS2003JP03691
Age:36 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
Disability
50 TO 100
TABLETS/DAY;
ORAL; REGIMEN
2, 40 MG/DAY;
PT
Report Source
Product
Role
Haemodialysis
Overdose
Renal Failure Acute
Rhabdomyolysis
Foreign
Health
Professional
Other
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
ORAL
ORAL
Depromel
(Fluvoxamine)
Depas (Etizolam)
Halcion (Triazolam)
Rohypnol
(Flunitrazepam)
Constan (Alprazolam)
C
C
C
C
C
Date:05/29/03ISR Number: 4124828-0Report Type:Expedited (15-DaCompany Report #PHEH2003US04330
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Chest Pain
Cough
Dyspnoea
Consumer
Ritalin-Sr
(Methylphenidate
Hydrochloride) Slow
Release Tablet
PS
Manufacturer
20 MG, QD,
ORAL
Date:05/30/03ISR Number: 4119520-2Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0409464A
Age:44 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 363
Route
Duration
PT
Abdominal Distension
Condition Aggravated
Constipation
Dizziness
Drug Withdrawal Syndrome
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Flatulence
Heart Rate Irregular
Hypersomnia
Dose
1
Report Source
Product
Role
Manufacturer
Route
Nausea
Paxil
PS
Glaxosmithkline
ORAL
Oliguria
Paraesthesia
Paralysis
Performance Status
Decreased
Ritalin
Adderall
SS
C
Duration
YR
ORAL
ORAL
Date:05/30/03ISR Number: 4120597-9Report Type:Expedited (15-DaCompany Report #NSADSS2003022356
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Condition Aggravated
Juvenile Arthritis
Tremor
Health
Professional
Concerta (18 Mg
Sustained Release
Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
DAY(S), ORAL
Date:05/30/03ISR Number: 4121513-6Report Type:Expedited (15-DaCompany Report #2003-05-3818
Age:36 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Fatigue
Overdose
Suicide Attempt
Foreign
Health
Professional
Aerius
(Desloratadine)
Tablets Like
Clarinex
PS
ORAL
Loratadine Tablets
SS
ORAL
Ritalin Tablets
SS
ORAL
5 X 5 MG ORAL
20 X 10 MG
ORAL
40 X 10 MG
ORAL
Cetirizine Tablets
SS
ORAL
Cefuroxime Tablets
SS
ORAL
Kepinol Tablets
SS
ORAL
Furosemid Tablets
SS
ORAL
7 X 10 MG
ORAL
12 X 250 MG
ORAL
9600 MG ORAL
26 X 40 MG
ORAL
Date:06/02/03ISR Number: 4121836-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB04081
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Cardiac Arrest
Circulatory Collapse
Electrocardiogram
Foreign
Health
Professional
Ritalin-Sr(Methylphe
nid Hydrochloride)
Slow Release Tablet
PS
ORAL
Abnormal
Other
Methylphenidate(Meth
ylphenidate
Hydrochloride)
SS
ORAL
Duration
20MG/DAY,
ORAL
Myocardial Infarction
Sudden Death
Ventricular Tachycardia
ORAL
18-Aug-2005
Page: 364
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/02/03ISR Number: 4121941-9Report Type:Expedited (15-DaCompany Report #PHFR2003GB01831
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Cardiac Arrest
Echocardiogram Abnormal
Electrocardiogram Qt
Foreign
Health
Professional
Methylphenidate(Meth
ylphenidate
Hydrochloride)
PS
Prolonged
Myocardial Infarction
Sudden Death
Other
Ritalin-Sr
(Methylphenidate
Hydrochloride)
SS
Manufacturer
Route
Duration
ORAL
ORAL
20 MG/DAY
Ventricular Tachycardia
Date:06/02/03ISR Number: 4121985-7Report Type:Expedited (15-DaCompany Report #PHBS2003JP03109
Age:46 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Erythema
Flushing
Ichthyosis Acquired
Foreign
Health
Professional
Anafranil(Clomiprami
ne
Hydrochloride)Tablet
PS
ORAL
Pigmentation Disorder
Other
Ritalin(Methylphenid
ate Hydrochloride)
SS
ORAL
Rohypnol(Flunitrazep
am)
SS
ORAL
Serenzin(Diazepam)
SS
ORAL
Reslin(Trazodone
Hydrochloride)
SS
ORAL
Duration
10 MG/DAY,
ORAL
Rash Papular
Xerosis
20 MG/DAY,
ORAL
2 MG/DAY,
ORAL
5 MG/DAY,
ORAL
75 MG/DAY,
ORAL
Miradol(Sulpiride)
SS
Ethyl Loflazepate
(Ethyl Loflazepate)
C
ORAL
300 MG/DAY,
ORAL
Date:06/05/03ISR Number: 4123732-1Report Type:Direct
Age:43 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization 5 MG BID ORAL
Initial or Prolonged
PT
Company Report #CTU 195062
Report Source
Product
Role
Nausea
Ritalin 5mg
PS
Vomiting
Placebo
SS
Manufacturer
Route
ORAL
Date:06/05/03ISR Number: 4125233-3Report Type:Expedited (15-DaCompany Report #CEL-2003-01087-SLO(0)
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Epistaxis
Foreign
Health
Professional
Equasym (Strength
Unspecified)
(Methylphenidate
Hydrochloride)
PS
Antibiotics
(Antibiotics)
C
SEE IMAGE
18-Aug-2005
Page: 365
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/05/03ISR Number: 4125604-5Report Type:Expedited (15-DaCompany Report #NSADSS2003024815
Age:13 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abdominal Pain Upper
Condition Aggravated
Dyspnoea
Electrocardiogram Qt
Health
Professional
Company
Representative
Concerta (36 Mg
Sustained Release
Tablet)
(Methylphenidate)
PS
Manufacturer
Route
ORAL
36 MG, 1 IN 1
Prolonged
DAILY, ORAL
Nausea
Date:06/09/03ISR Number: 4126414-5Report Type:Expedited (15-DaCompany Report #EMADSS2003004553
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hallucination
Insomnia
Foreign
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:06/09/03ISR Number: 4126416-9Report Type:Expedited (15-DaCompany Report #EMADSS2003004554
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Facial Palsy
Hemiplegia
Iiird Nerve Paralysis
Foreign
Health
Professional
Concerta(Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
DAILY, ORAL
Date:06/09/03ISR Number: 4126444-3Report Type:Expedited (15-DaCompany Report #EMADSS2003004226
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Disability
Chest Pain
Musculoskeletal Pain
Viral Infection
Foreign
Health
Professional
Concerta (Sustained
Release Tablet)
(Methylphenidate
Hydrochloride)
PS
ORAL
36 MG, 1 IN 1
TIME(S), ORAL
Melatonin
(Melatonin)
Ritalin
(Methylphenidate
Hydrochloride)
..
Date:06/13/03ISR Number: 4128430-6Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Disability
18-Aug-2005
Page: 366
PT
C
C
C
Company Report #CTU 195703
Report Source
Product
Role
Ritalin
Zoloft
PS
SS
Duration
Bedridden
Fatigue
Rhinorrhoea
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/16/03ISR Number: 4129396-5Report Type:Direct
Age:30 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
30MG BID
PT
Company Report #CTU 195803
Report Source
Product
Role
Manufacturer
Route
Adderall
PS
ORAL
Ritalin
SS
ORAL
Duration
Ear Pain
Facial Pain
DAILY ORAL
Gingival Disorder
70MG DAILY
Hyperacusis
ORAL
Hypoaesthesia
Mastication Disorder
Mobility Decreased
Muscle Spasms
Myalgia
Pain In Jaw
Paraesthesia
Trismus
Date:06/16/03ISR Number: 4130471-XReport Type:Expedited (15-DaCompany Report #PHBS2003CH05877
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Appendicectomy
Pancreatitis Acute
Foreign
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
10 MG/DAY
Other
Date:06/16/03ISR Number: 4130472-1Report Type:Expedited (15-DaCompany Report #PHNU2003DE02168
Age:37 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
30MG/DAY,
PT
Report Source
Product
Role
Blood Creatine
Phosphokinase Increased
Blood Creatine
Phosphokinase Mb
Foreign
Consumer
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
ORAL
Increased
ORAL
Chest Pain
Date:06/17/03ISR Number: 4131597-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030600089
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Growth Retardation
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:06/17/03ISR Number: 4131873-8Report Type:Expedited (15-DaCompany Report #EMADSS2003004554
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
ORAL
18-Aug-2005
Page: 367
11:49 AM
PT
Report Source
Product
Role
Cerebral Artery Occlusion
Facial Palsy
Hemiplegia
Iiird Nerve Paralysis
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/17/03ISR Number: 4131901-XReport Type:Expedited (15-DaCompany Report #EMADSS2003001241
Age:10 YR
Gender:
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Decreased Appetite
Gilbert'S Syndrome
Headache
Jaundice
Nausea
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
DAY; ORAL
Equasym
(Unspecified)
Methylphenidate
Hydrochloride
Melatonin
(Unspecified)
Melatonin
Date:06/18/03ISR Number: 4131168-2Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
54 MG
PO
Required
QAM
Intervention to
Prevent Permanent
Impairment/Damage
PT
Outcome
Dose
Duration
Hospitalization -
PT
Hallucinations, Mixed
C
Company Report #CTU 196121
Report Source
Hallucination, Visual
Date:06/18/03ISR Number: 4131169-4Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
C
Product
Role
Manufacturer
Route
Concerta (Johnson &
Johnson)
PS
Johnson & Johnson
ORAL
Risperdal
Zoloft
Tenez
Depakote
Dexadrine
C
C
C
C
C
Manufacturer
Route
Company Report #CTU 196122
Report Source
Product
Concerta Johnson &
Role
Initial or Prolonged
54 MG PO Q AM
Required
Intervention to
Prevent Permanent
Impairment/Damage
Suicide Attempt
Date:06/18/03ISR Number: 4131170-0Report Type:Direct
Age:6 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
36 MG PO QAM
Required
Intervention to
Prevent Permanent
Impairment/Damage
18-Aug-2005
Page: 368
11:49 AM
PT
Hallucinations, Mixed
Johnson
PS
Wellbutrin Se
Zyprexa
Colace
Maalox
C
C
C
C
Johnson & Johnson
ORAL
Company Report #CTU 196123
Report Source
Product
Role
Manufacturer
Route
Concerta, Johnson &
Johnson
PS
Johnson & Johnson
ORAL
Dexadrine
Prozac
C
C
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/18/03ISR Number: 4131171-2Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
36 MG PO QAM
Required
Intervention to
Prevent Permanent
Impairment/Damage
PT
Company Report #CTU 196124
Report Source
Product
Role
Manufacturer
Route
Abnormal Behaviour
Disorientation
Concerta, Johnson &
Johnson
PS
Johnson & Johnson
ORAL
Excitability
Mania
Lithium
Zyprexa
Clonidine
Paxil
Ritalin
C
C
C
C
C
Manufacturer
Route
Date:06/18/03ISR Number: 4132138-0Report Type:Expedited (15-DaCompany Report #PHBS2003JP05996
Age:20 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Death
Foreign
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
PS
Duration
ORAL
ORAL
Other
Date:06/19/03ISR Number: 4133059-XReport Type:Expedited (15-DaCompany Report #HQWYE536110JUN03
Age:48 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Anorexia
Back Pain
Confusional State
Literature
Effexor (Venlafaxine
Hydrochloride,
Unspec)
PS
Methylphenidate
(Methylphenidate,)
SS
Zolpidem (Zolpidem,)
SS
SEE IMAGE
Depressed Level Of
Consciousness
10 MG 3X PER
Depressed Mood
1 DAY
7
YR
Disorientation
10 MG 1X PER
Drug Interaction
1 DAY
Manufacturer
Route
ORAL
Drug Withdrawal Syndrome
Electrolyte Imbalance
Grand Mal Convulsion
Insomnia
Intentional Misuse
Metabolic Disorder
Mood Altered
Muscle Spasms
Nausea
Somnolence
Date:06/20/03ISR Number: 4133714-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030600095
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG, ORAL
18-Aug-2005
Page: 369
PT
Report Source
Product
Role
Confusional State
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/20/03ISR Number: 4133715-3Report Type:Expedited (15-DaCompany Report #NSADSS2003011394
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Biopsy Bone Marrow
Abnormal
Pancytopenia
Pyrexia
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)Sustai
ned
PS
ORAL
Remeron
(Mirtazapine)
SS
ORAL
54 MG, 1 IN 1
DAY, ORAL
30 MG, 1 IN 1
DAY, ORAL
Date:06/20/03ISR Number: 4133717-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030600600
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Chills
Cough
Fatigue
Listless
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Tegretol
(Carbamazepine)
C
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
Pallor
DAY, ORAL
Date:06/20/03ISR Number: 4133722-0Report Type:Expedited (15-DaCompany Report #NSADSS2003024815
Age:13 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Abdominal Pain Upper
Dyspnoea
Electrocardiogram Qt
Prolonged
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Role
Manufacturer
Route
Nausea
Tablets
PS
ORAL
36 MG, 1 IN 1
DAY, ORAL
Date:06/20/03ISR Number: 4134188-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB02326
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abnormal Behaviour
Agitation
Mydriasis
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
Other
Methylenedioxyamphet
amine
C
Manufacturer
Route
Duration
ORAL
ORAL
Date:06/25/03ISR Number: 4135688-6Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Ritalin 30mg At
800am, 20mg At 200
PS
Duration
Drug Hypersensitivity
Pharmaceutical Product
Complaint
18-Aug-2005
Page: 370
Company Report #CTU 196638
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/25/03ISR Number: 4136208-2Report Type:Expedited (15-DaCompany Report #NSADSS2003012338
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Chest Pain
Fall
Gait Disturbance
Heart Rate Decreased
Lethargy
Consumer
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Clonidine (Tablets)
Clonidine
C
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Loss Of Consciousness
Medication Error
Date:06/25/03ISR Number: 4163033-9Report Type:Periodic
Age:
Gender:Female
I/FU:I
Outcome
Dose
Company Report #USA030229857
PT
Report Source
Product
Role
Cough
Feeling Cold
Malaise
Consumer
Strattera
(Atomoxetine
Hydrochloride)
PS
Prozac-Oral
(Fluoxetine)
(Fluoxetine
Hydrochloride)
SS
Manufacturer
Route
Manufacturer
Route
Duration
25 MG/DAY
Pulmonary Congestion
60 MG/DAY
Concerta
Methylphenidate
Hydrochloride)
Provigi; (Modafinil)
Wellbutrin
(Bupropion
Hydrochloride)
Date:06/25/03ISR Number: 4163415-5Report Type:Periodic
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
SS
C
C
Company Report #USA030229650
PT
Report Source
Product
Abdominal Pain Upper
Abnormal Behaviour
Consumer
Strattera
(Atomoxetine
Duration
Role
Crying
Hydrochloride)
PS
Decreased Appetite
Dizziness
Eye Disorder
Flushing
Concerta
(Methylphenidate
Hydrochloride)
SS
18 MG/DAY
Date:06/27/03ISR Number: 4138233-4Report Type:Expedited (15-DaCompany Report #PHFR2002GB04081
Age:13 YR
Gender:Male
I/FU:F
Outcome
Death
18-Aug-2005
Page: 371
PT
Arrhythmia
Cardiac Arrest
Chromosome Abnormality
Circulatory Collapse
Echocardiogram Abnormal
Electrocardiogram
Repolarisation
Abnormality
Medication Error
Mineral Metabolism
Disorder
Myocardial Infarction
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pupil Fixed
Sudden Death
Ventricular Tachycardia
Dose
Report Source
Product
Role
Manufacturer
Route
Foreign
Health
Professional
Other
Ritalin-Sr(Methylphe
nidate
Hydrochloride) Slow
Release Tablet
PS
ORAL
Methylphenidate(Meth
ylphenidate
Hydrochloride)
Unknown
SS
ORAL
Duration
20MG/DAY,
ORAL
UNK, UNK,
ORAL
Date:06/27/03ISR Number: 4138241-3Report Type:Expedited (15-DaCompany Report #2003-05-3818
Age:36 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Excitability
Fatigue
Intentional Misuse
Suicide Attempt
Foreign
Health
Professional
Aerius
(Desloratadine)
Tablets "Like
Clarinex"
PS
ORAL
Loratadine Tablets
SS
ORAL
Ritalin Tablets
SS
ORAL
Cetirizine Tablets
SS
ORAL
Cefuroxime Tablets
SS
ORAL
Manufacturer
Route
5 X 5 MG ORAL
Tachycardia
20 X 10 MG
ORAL
40 X 10 MG
ORAL
7 X 10 MG
ORAL
12 X 250 MG
ORAL
Kepinol Tablets
SS
ORAL
Furosemid Tablets
SS
ORAL
9600 MG ORAL
26 X 40 MG
ORAL
Date:06/27/03ISR Number: 4138503-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE02262
Age:18 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Prolactinoma
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:06/27/03ISR Number: 4138534-XReport Type:Expedited (15-DaCompany Report #EMADSS2003004554
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Cerebral Artery Occlusion
Echopraxia
Facial Palsy
Hemiplegia
Iiird Nerve Paralysis
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
Laboratory Test Abnormal
Vasculitis
18-Aug-2005
Page: 372
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/27/03ISR Number: 4139357-8Report Type:Expedited (15-DaCompany Report #PHEH2003US04978
Age:49 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Drug Dependence
Consumer
Ritalin(Methylphenid
ate Hydrochloride)
Unknown
PS
Manufacturer
Route
Manufacturer
Route
Duration
2190 DAY
Date:06/27/03ISR Number: 4139366-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030603190
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Medication Residue
Pharmaceutical Product
Complaint
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained
PS
Duration
ORAL
ORAL
Date:06/27/03ISR Number: 4195954-5Report Type:Periodic
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
Company Report #PHEH2003US01390
PT
Report Source
Product
Role
Manufacturer
Route
Chest Pain
Health
Professional
Ritalin
La(Methylphenidate
Hydrochloride)
Extended Release
Capsules
PS
ORAL
Ritalin(Methylphenid
ate Hydrochloride)
Tablet
SS
ORAL
Duration
40 MG, QD
ORAL
10 MG. Q4PM,
ORAL
Date:07/01/03ISR Number: 4140763-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030602875
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Abnormal Behaviour
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Ritalin
(Methylphenidate
Hydrochloride)
C
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
DAY, ORAL
Date:07/01/03ISR Number: 4140765-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030603416
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Abnormal Behaviour
Drug Ineffective
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Ritalin
(Methylphenidate
Hydrochloride)
Unknown
C
18 MG, 2 IN 1
DAY, ORAL
18-Aug-2005
Page: 373
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/01/03ISR Number: 4140775-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030602880
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Attention
Deficit/Hyperactivity
Disorder
Condition Aggravated
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Melatonin
(Melatonin) Unknown
C
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
DAY, ORAL
Date:07/02/03ISR Number: 4141677-8Report Type:Expedited (15-DaCompany Report #NSADSS2003024795
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abdominal Pain Upper
Anorexia
Weight Decreased
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
18 MG 1 IN 1
DAY ORAL
Qvar ()
Beclometasone
Dipropionate
Albuterol ()
Salbutamol
Motrin () Ibuprofen
Claritin
(Loratadine)
C
C
C
C
Date:07/02/03ISR Number: 4141691-2Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20030602514
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Amnesia
Foreign
Concerta
Duration
Role
Manufacturer
Route
Confusional State
Depressed Level Of
Consciousness
Health
Professional
(Methylphenidate
Hydrochloride)
Sustained
PS
ORAL
36 MG, 1 IN 1
Hallucination, Visual
DAY, ORAL
Myalgia
Restlessness
Retrograde Amnesia
Self Mutilation
Date:07/02/03ISR Number: 4141696-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB02426
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 374
PT
Report Source
Product
Role
Platelet Count Increased
Red Blood Cell Count
Increased
White Blood Cell Count
Increased
Foreign
Health
Professional
Other
Ritaline(Methylpheni
date Hydrochloride)
Unknown
PS
Duration
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/07/03ISR Number: 4142846-3Report Type:Direct
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 197281
Report Source
Product
Role
Generic
Methylphenidate
PS
Manufacturer
Route
Manufacturer
Route
Duration
Drug Ineffective
Pharmaceutical Product
15 MGM BID
Complaint
(O)
7
YR
Date:07/07/03ISR Number: 4144100-2Report Type:Expedited (15-DaCompany Report #NSADSS2003022997
Age:8 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Agitation
Hallucination
Medication Error
Health
Professional
Conerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
ORAL
27 MG, 1 IN 1
DAY, ORAL
Date:07/07/03ISR Number: 4144103-8Report Type:Expedited (15-DaCompany Report #NSADSS2002038804
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Hallucinations, Mixed
Psychotic Disorder
Suicide Attempt
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
54 MG, 1 IN 1
DAY, ORAL
Wellbutrin
(Bupropion
Hydrochloride)
Tablets
Zyprexa (Olanzapine)
C
Manufacturer
Route
ORAL
Tablets
Colace (Docusate
Sodium) Capsules
C
C
Date:07/07/03ISR Number: 4144628-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030603419
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Thrombocytopenia
Foreign
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Medikinet
(Methylphenidate
Hydrochloride)
Tablets
C
1 TABLET,
DAILY.
18-Aug-2005
Page: 375
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/08/03ISR Number: 4143391-1Report Type:Direct
Age:13 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Company Report #CTU 197475
Report Source
Product
Role
Concerta 36 Mg
PS
Manufacturer
Route
Manufacturer
Route
Duration
Sinus Arrhythmia
Date:07/08/03ISR Number: 4144785-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE02168
Age:37 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Blood Creatine
Phosphokinase Increased
Blood Creatine
Foreign
Health
Professional
Ritaline(Methylpheni
date
Hydrochloride)Tablet
PS
Phosphokinase Mb
Other
Citalopram
(Citalopram)
C
ORAL
10 MG, TID,
ORAL
Increased
Chest Discomfort
Chest Pain
Date:07/08/03ISR Number: 4144815-6Report Type:Expedited (15-DaCompany Report #CEL-2003-00916-ROC
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Drug Ineffective
Health
Methylphenidate
PS
Pharmaceutical Product
Complaint
Professional
Other
Manufacturer
Route
Manufacturer
Route
Duration
20 MG
Date:07/08/03ISR Number: 4145198-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE02444
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Blood Alkaline
Phosphatase Increased
Blood Glucose Decreased
Foreign
Health
Professional
Ritalin-Sr
(Methylphenidate
Hydrochloride)
Duration
Role
Hypoglycaemia
Other
Tablet
PS
ORAL
ORAL
Leukocytosis
Sinus Tachycardia
Date:07/08/03ISR Number: 4145274-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE02428
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Erectile Dysfunction
Prescribed Overdose
Foreign
Consumer
Other
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
UP TO
300MG/DAY,
ORAL
Date:07/08/03ISR Number: 4145289-1Report Type:Expedited (15-DaCompany Report #PHEH2003US05290
Age:81 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
UNKNOWN
Report Source
Product
Role
Aortic Valve Disease
Overdose
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
Unknown
PS
100 MG 5
TIMES A DAY
UNK
18-Aug-2005
Page: 376
PT
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
UNKNOWN
40 MG UNK
UNKNOWN
1.2 G, QD,
Ritalin-Sr
(Methylphenidate
Hydrochloride) Slow
Release Tablet
SS
Provigil (Modafinil)
SS
UNK
Date:07/08/03ISR Number: 4145302-1Report Type:Expedited (15-DaCompany Report #PHBS2003JP06699
Age:29 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Drug Dependence
Foreign
Literature
Health
Ritalin(Methylphenid
ate Hydrochloride)
Unknown
PS
Manufacturer
Route
Duration
ORAL
20 MG/DAY,
Professional
ORAL
Other
Date:07/09/03ISR Number: 4144411-0Report Type:Direct
Age:43 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Anafranil
Sulpiride
Trazodone
Hydrochloride
Fluvoxamine
Milnacipran
Hydrochloride
Valproate Sodium
Amoxapine
C
C
C
C
C
C
C
Company Report #USP 55957
Report Source
Product
Role
Manufacturer
Methylphenidate
Methadone
PS
SS
Mallinckrodt
Mallinckrodt
Duration
Dizziness
Feeling Abnormal
Medication Error
Route
Date:07/09/03ISR Number: 4146261-8Report Type:Expedited (15-DaCompany Report #NSADSS2002038977
Age:7 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Hallucinations, Mixed
Psychotic Disorder
Health
Professional
Company
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
36 MG, 1 IN 1
Representative
DAY, ORAL
Prozac (Fluoxetine
Hydrochloride)
Albuterol Mdi
(Salbutamol)
C
C
Date:07/10/03ISR Number: 4146674-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030600469
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Anaemia
Anorexia
Inflammatory Bowel
Disease
Liver Function Test
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
36 MG, 1 IN 1
Abnormal
DAY, ORAL
18-Aug-2005
Page: 377
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/10/03ISR Number: 4146893-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030701084
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Cyanosis
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Manufacturer
Route
Duration
54 MG
Date:07/11/03ISR Number: 4145267-2Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0302394A
Age:20 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization 20MG per day
Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Neuroleptic Malignant
Paroxetine
PS
Glaxosmithkline
ORAL
Syndrome
Methylphenidate
Hydrochloride
Milnacipran
Hydrochloride
Date:07/14/03ISR Number: 4146439-3Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Life-Threatening
Other
6 DAY
PT
SS
ORAL
C
ORAL
Company Report #CTU 197846
Report Source
Drug Ineffective
Drug Screen Negative
Product
Role
Methylphenidate 20
Milligrams
PS
Manufacturer
Route
Manufacturer
Route
Pharmaceutical Product
Complaint
Weight Increased
Date:07/14/03ISR Number: 4147962-8Report Type:Expedited (15-DaCompany Report #PHEH2003US05548
Age:41 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization -
PT
Report Source
Product
Arterial Occlusive
Health
Ritalin(Methylphenid
Role
Initial or Prolonged
Disease
Myocardial Infarction
Professional
ate Hydrochloride)
Tablet, 5mg
PS
ORAL
5 MG, QD,
ORAL
Levothyroxine
(Levothyroxine)
Prozac (Fluoxetine
Hydrochloride)
C
C
Date:07/14/03ISR Number: 4148288-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030702159
Age:
Gender:
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Accidental Exposure
Insomnia
Muscle Twitching
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
27MG, 1 OR 2
Psychomotor Hyperactivity
CAPSULES
Date:07/16/03ISR Number: 4150419-1Report Type:Expedited (15-DaCompany Report #PHNU2003DE02480
Age:
Gender:Female
I/FU:I
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 378
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Other
Dose
PT
Report Source
Product
Role
Manufacturer
Route
Arrhythmia
Blood Potassium Decreased
Foreign
Consumer
Other
Ritaline(Methylpheni
date
Hydrochloride)Tablet
PS
ORAL
Ritalin-Sr(Methylphe
nidate
Hydrochloride)Slow
Release Tablet
SS
ORAL
Trevilor
(Venlafaxine
Hydrochloride)
SS
ORAL
Lorzaar Plus
(Losartan Potassium)
C
Duration
ORAL
ORAL
1 DF,
ONCE/SINGLE,
ORAL
Date:07/21/03ISR Number: 4150385-9Report Type:Expedited (15-DaCompany Report #CA-GLAXOSMITHKLINE-A0417271A
Age:33 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
Other
PT
Report Source
Product
Role
Manufacturer
Bupropion
Benadryl
Ritalin
Codeine
Acetaminophen
PS
SS
SS
SS
SS
Glaxosmithkline
Glaxosmithkline
Product
Role
Manufacturer
Concerta 38 Mcneil
Pharmaceutical
PS
Mcneil
Route
Duration
Completed Suicide
Intentional Misuse
Oedema
Pulmonary Congestion
Date:07/21/03ISR Number: 4151192-3Report Type:Direct
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Life-Threatening
Required
PT
Anxiety
Gastrointestinal Ulcer
Glaxosmithkline
Company Report #CTU 198301
Report Source
Route
Intervention to
1 CAPSU ONCE
Prevent Permanent
A DAY ORAL
Impairment/Damage
Gastrooesophagitis
Pharmaceutical
ORAL
Manufacturer
Route
Manufacturer
Route
Date:07/21/03ISR Number: 4152910-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB02426
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Platelet Count Increased
Red Blood Cell Count
Increased
White Blood Cell Count
Increased
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
PS
Duration
Date:07/21/03ISR Number: 4152943-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB02326
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Abnormal Behaviour
Agitation
Drug Abuser
Foreign
Health
Professional
Ritaline(Methylpheni
date Hydrochloride)
Tablet
PS
Mydriasis
Other
Methylenedioxyamphet
amine(Methylenedioxy
Duration
ORAL
18-Aug-2005
Page: 379
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
amphetamine)
SS
Date:07/21/03ISR Number: 4153194-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030703323
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Arthralgia
Haematuria
Pyrexia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Released
Tablets
PS
Phenergan
(Promethazine
Hydrochloride)
C
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
DAY, ORAL
Date:07/22/03ISR Number: 4153693-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE02607
Age:15 YR
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Amaurosis Fugax
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
15 MG/DAY,
ORAL
Date:07/22/03ISR Number: 4154074-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE02679
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
15 TO 20
PT
Report Source
Product
Role
Hydrocele
Post Procedural
Haemorrhage
Foreign
Health
Professional
Ritaline
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
Varicocele
Other
MG/DAY, ORAL
Date:07/22/03ISR Number: 4154087-4Report Type:Expedited (15-DaCompany Report #PHBS2003JP06699
Age:29 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Drug Dependence
Drug Effect Decreased
Mania
Foreign
Literature
Health
Ritalin
(Methylphenidate
Hydrochloride)
PS
20 MG/DAY,
Professional
ORAL
Other
18-Aug-2005
Page: 380
Manufacturer
Route
Duration
11:49 AM
Anafranil Tablet
Sulpiride
(Sulpiride)
Trazodone
Hydrochloride
Fluvoxamine
(Fluvoxamine)
Milnacipran
Hydrochloride
(Milnacipran
Hydrochloride)
Valproate Sodium
Amoxapine
(Amoxapine)
C
C
C
C
C
C
C
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/24/03ISR Number: 4153418-9Report Type:Expedited (15-DaCompany Report #PHBS2003ES05736
Age:47 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
UNKNOWN
UNKNOWN
PT
Report Source
Product
Role
Manufacturer
Methylphenidate
PS
Novartis Sector:
Pharma
Clomipramine
SS
Route
Duration
Cataplexy
Drug Withdrawal Syndrome
10 mg/day
Somnolence
75 mg/day
Date:07/24/03ISR Number: 4153421-9Report Type:Expedited (15-DaCompany Report #PHBS2003ES05735
Age:81 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
UNKNOWN
UNKNOWN
PT
Report Source
Product
Role
Manufacturer
Methylphenidate
PS
Novartis Sector:
Pharma
Clomipramine
SS
Route
Duration
Asthenia
Cataplexy
20 mg/day
Drug Withdrawal Syndrome
75 mg/day
Somnolence
Date:07/24/03ISR Number: 4156064-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030704561
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hypersomnia
Idiopathic
Thrombocytopenic Purpura
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Risperidal
(Risperidone)
Tablets
C
Manufacturer
Route
Duration
SEE IMAGE
Date:07/24/03ISR Number: 4156369-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030701084
Age:6 YR
Gender:Male
I/FU:F
ORAL
Outcome
Dose
Other
PT
Report Source
Product
Role
Cyanosis
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
B-Calm (Herbal
Preparation) Tablets
C
Manufacturer
Route
Manufacturer
Route
Duration
SEE IMAGE
Date:07/25/03ISR Number: 4156880-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB02426
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
18-Aug-2005
Page: 381
PT
Report Source
Product
Role
Neutropenia
Red Blood Cell Count
Increased
Thrombocythaemia
White Blood Cell Count
Increased
Foreign
Health
Professional
Other
Ritaline(Methylpheni
date Hydrochloride)
Unknown
PS
Duration
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/28/03ISR Number: 4155476-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12217170
Age:16 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
50-100 mg
PT
Product
Role
Alanine Aminotransferase
Trazodone Hcl Tabs
PS
ORAL
Increased
Aspartate
Aminotransferase
Increased
Epistaxis
Gamma-Glutamyltransferase
Increased
Lipids Increased
Liver Function Test
Abnormal
Concerta Xl
Isotretinoin
SS
C
ORAL
Date:07/28/03ISR Number: 4155863-4Report Type:Direct
Age:7 YR
Gender:
I/FU:I
Outcome
Dose
Report Source
Manufacturer
Route
Duration
PT
Company Report #USP 50341
Report Source
Product
Role
Manufacturer
Blood Glucose Decreased
Ritalin
PS
Ciba
Brain Damage
Glynase
SS
Upjohn
Route
Duration
TABLET
TABLET
Coma
Convulsion
Medication Error
Mental Retardation
Severity Unspecified
Overdose
Date:07/29/03ISR Number: 4159715-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030706353
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Serum Sickness
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Duration
Role
Manufacturer
Route
Tablets
PS
ORAL
ORAL
Date:07/30/03ISR Number: 4158968-7Report Type:Expedited (15-DaCompany Report #PHBS2003NL07681
Age:37 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Duration
Affect Lability
Apathy
Chest Pain
Dyspnoea
Jaundice
Pneumothorax
Rash
Vision Blurred
Date:07/30/03ISR Number: 4158969-9Report Type:Expedited (15-DaCompany Report #PHBS2003JP06515
Age:88 YR
Gender:Female
I/FU:F
Outcome
Death
Other
18-Aug-2005
Page: 382
PT
Death
Hallucination
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Nausea
Tremor
Report Source
Dose
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Duration
10 mg/day
Symmetrel
SS
ORAL
Symmetrel
SS
ORAL
Gramalil
C
ORAL
150 mg/day
100 mg/day
1 tablet/day
Date:07/30/03ISR Number: 4161019-1Report Type:Expedited (15-DaCompany Report #MK200307-0716-1
Age:81 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Anal Neoplasm
Cataplexy
Drug Withdrawal Syndrome
Narcolepsy
Foreign
Literature
Clomipramine 75mg
(Mrf Unknown)
Methylphenidate (Mfr
Unknown)
Role
Manufacturer
Route
Manufacturer
Route
PS
SS
Date:07/30/03ISR Number: 4162102-7Report Type:Expedited (15-DaCompany Report #PHBS2003ES05736
Age:47 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Cataplexy
Drug Withdrawal Syndrome
Foreign
Literature
Health
Clomipramine(Clomipr
amine Hydrochloride)
Unknown
PS
Professional
Other
Methylphenidate
(Methylphenidate
Hydrochloride)
Unknown
SS
Duration
75 MG/DAY
10 MG/DAY
Date:07/30/03ISR Number: 4162117-9Report Type:Expedited (15-DaCompany Report #PHBS2003ES05735
Age:81 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abnormal Dreams
Anal Neoplasm
Asthenia
Foreign
Literature
Health
Clomipramine(Clomipr
amin Hydrochloride)
Unknown
PS
Cataplexy
Drug Withdrawal Syndrome
Narcolepsy
Somnolence
Professional
Other
Methylphenidate(Meth
ylphenidate
Hydrochloride)
Unknown
SS
Manufacturer
Route
Manufacturer
Route
Duration
75 MG/DAY
20 MG/DAY
Date:07/31/03ISR Number: 4162040-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030602880
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Attention
Deficit/Hyperactivity
Disorder
Condition Aggravated
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Melatonin
(Melatonin)
C
Duration
36 MG, 1 IN 1
DAY, ORAL
18-Aug-2005
Page: 383
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/31/03ISR Number: 4162041-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030603416
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Abnormal Behaviour
Drug Ineffective
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Rtalin
(Methylphenidate
Hydrochloride)
C
Manufacturer
Route
Duration
ORAL
18 MG, 2 IN 1
DAY, ORAL
Date:07/31/03ISR Number: 4162042-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030602875
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Abnormal Behaviour
Condition Aggravated
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Ritalin
(Methylphenidate
Hydrochloride)
C
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
DAY, ORAL
Date:07/31/03ISR Number: 4162045-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030600095
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG, ORAL
PT
Report Source
Product
Role
Confusional State
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
Date:07/31/03ISR Number: 4162068-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030600089
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Growth Retardation
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:08/01/03ISR Number: 4206308-7Report Type:Periodic
Age:13 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Company Report #CEL-2003-01115-ROC (0)
PT
Report Source
Product
Role
Convulsion
Face Injury
Fall
Loss Of Consciousness
Consumer
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Theraflu (Theraflu)
SS
20 MG (20 MG,
Streptococcal Infection
Q AM), PO
18-Aug-2005
Page: 384
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/04/03ISR Number: 4160293-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB02426
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
Product
Role
Manufacturer
Ritalin
PS
Novartis Sector:
Pharma
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Infection
Neutrophilia
UNKNOWN
Rash
Red Blood Cell Count
Increased
Thrombocythaemia
White Blood Cell Count
Increased
Date:08/04/03ISR Number: 4160491-0Report Type:Expedited (15-DaCompany Report #PHBS2001NZ12212
Age:24 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Drug Abuser
Medication Error
Oedema Peripheral
Peripheral Ischaemia
Skin Discolouration
Route
Date:08/04/03ISR Number: 4160577-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE02679
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
15 to 20
PT
Hydrocele
Post Procedural
Report Source
Haemorrhage
mg/day
Varicocele
Date:08/04/03ISR Number: 4161001-4Report Type:Direct
Age:
Gender:Male
I/FU:I
Company Report #CTU 199127
Outcome
Dose
PT
Report Source
Abnormal Behaviour
Mood Altered
Date:08/04/03ISR Number: 4161245-1Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Other
Product
Role
Ritalin 30-10-10
Celexa 20
PS
SS
Manufacturer
Route
Route
Duration
PT
Company Report #USP 50174
Report Source
Product
Role
Manufacturer
Ritodrine
Ritalin
PS
SS
Ciba
Role
Manufacturer
Duration
Developmental Delay
Maternal Drugs Affecting
Foetus
Medication Error
Date:08/04/03ISR Number: 4163841-4Report Type:Expedited (15-DaCompany Report #2003-BP-05192RO
Age:41 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Death
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 385
11:49 AM
PT
Report Source
Product
Agitation
Coma
Oxygen Saturation
Decreased
Snoring
Literature
Health
Professional
Other
Methadone
(Methadone)
Methylphenidate
(Methylphenidate)
Crack Cocaine
PS
SS
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
(Cocaine)
SS
Date:08/04/03ISR Number: 4163913-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030707098
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Oculogyration
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
DAY, ORAL
Date:08/04/03ISR Number: 4164217-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030706439
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Photosensitivity Reaction
Systemic Lupus
Erythematosus
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Manufacturer
Route
Manufacturer
Route
Duration
Date:08/05/03ISR Number: 4165416-XReport Type:Expedited (15-DaCompany Report #CEL-2003-02764-ROC
Age:41 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Agitation
Coma
Drug Abuser
Oxygen Saturation
Decreased
Pulmonary Oedema
Respiratory Disorder
Snoring
Somnolence
Stupor
Literature
Health
Professional
Methylphenidate
Tablets
(Unspecified)(Methyl
phenidate
Hydrochloride)
Methadone
(Methadone)
Cocaine (Cocaine)
Role
Duration
PS
SS
SS
Date:08/05/03ISR Number: 4165483-3Report Type:Expedited (15-DaCompany Report #CEL-2003-02704-ROC
Age:48 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Back Pain
Blood Calcium Decreased
Blood Potassium Decreased
Blood Sodium Decreased
Condition Aggravated
Literature
Health
Professional
Methylphenidate
Tablets
(Unspecified)
(Methylphenidate
Hydrochloride)
PS
ORAL
Venlafaxine
(Venlafaxine)
SS
ORAL
Zolpidem (Zolpidem)
SS
ORAL
30 MG (10 MG,
Drug Withdrawal Syndrome
TID), PO
Grand Mal Convulsion
Haematocrit Decreased
600 MG
Haemoglobin Decreased
(DAILY), PO
Insomnia
10 MG (10 MG,
Muscle Spasms
HS), PO
Nausea
Platelet Count
Red Blood Cell Count
Decreased
Self-Medication
White Blood Cell Count
Increased
18-Aug-2005
Page: 386
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/06/03ISR Number: 4162496-2Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0383131A
Age:42 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Bupropion
Methylphenidate
PS
SS
Glaxosmithkline
ORAL
Manufacturer
Route
Duration
Cerebral Infarction
Completed Suicide
UNKNOWN
Cyanosis
Drug Level Increased
Intentional Misuse
Loss Of Consciousness
Nervous System Disorder
Renal Failure
Respiratory Failure
Shock
Date:08/06/03ISR Number: 4165420-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030603419
Age:
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Fall
Haematoma
Petechiae
Skin Haemorrhage
Thrombocytopenia
Foreign
Consumer
Concerta
(Methylphenidate
Hydrochloride) Sus
Tained Release
Tablets
PS
Medikinet (Tablets(
Methylphenidate
Hydrochloride
C
1
TABLET/DAILY.
Date:08/07/03ISR Number: 4163239-9Report Type:Expedited (15-DaCompany Report #PHEH2003US06719
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Coordination Abnormal
Dysarthria
Ritalin La
PS
Novartis Sector:
Pharma
ORAL
Musculoskeletal Stiffness
Flonase
Duration
20 mg, QD
C
Montelukast Sodium
C
Date:08/08/03ISR Number: 4163969-9Report Type:Expedited (15-DaCompany Report #PHBS2001NZ12213
Age:42 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Erythema
Groin Pain
Local Swelling
Mycotic Aneurysm
Oedema Peripheral
Pitting Oedema
Sepsis
Vascular Pseudoaneurysm
Wound Necrosis
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Pharma
Date:08/09/03ISR Number: 4167362-4Report Type:Expedited (15-DaCompany Report #HQWYE525831JUL03
Age:18 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 387
PT
Gun Shot Wound
Murder
11:49 AM
Report Source
Consumer
Company
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Representative
Dose
Product
Role
Effexor (Venlafaxine
Hydrochloride,
Tablet)
PS
Manufacturer
Route
Duration
ORAL
ORAL
Ambien (Zolpidem
Tartrate)
Clonazepam
(Clonazepam)
Methylphenidate
(Methylphenidate)
Wellbutrin
(Amfebutamone
Hydrochloride)
SS
SS
SS
SS
Date:08/11/03ISR Number: 4164614-9Report Type:Expedited (15-DaCompany Report #PHEH2003US06788
Age:
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Ritalin
PS
Novartis Sector:
Pharma
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Pharma
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Route
Duration
Sudden Death
Unk/Unk
Date:08/11/03ISR Number: 4165371-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB03027
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Route
Duration
Tachycardia
Ventricular Hypertrophy
Date:08/11/03ISR Number: 4165373-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE02428
Age:
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Duration
Erectile Dysfunction
Route
Prescribed Overdose
Pharma
ORAL
up to
300mg/day
Date:08/12/03ISR Number: 4166035-1Report Type:Expedited (15-DaCompany Report #PHNU2003DE02965
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
20mg/day
PT
Report Source
Ear Discomfort
Hypoacusis
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Vertigo
Date:08/12/03ISR Number: 4168814-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030603419
Age:
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
1 TABLET,
DAILY.
18-Aug-2005
Page: 388
11:49 AM
PT
Report Source
Product
Role
Fall
Haematoma
Petechiae
Skin Haemorrhage
Thrombocytopenia
Foreign
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Medikinet
(Methylphenidate
Hydrochloride)
Tablets
C
Date:08/13/03ISR Number: 4166789-4Report Type:Expedited (15-DaCompany Report #PHBS2003JP03691
Age:36 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
Hospitalization 50 to 100
Initial or Prolonged
tablets/day
2880 MIN
PT
Report Source
Depressed Mood
Dialysis
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Muscular Weakness
Overdose
Renal Failure Acute
Ritalin
SS
Rhabdomyolysis
Depromel
C
ORAL
Depas
C
ORAL
Halcion
C
ORAL
Rohypnol
C
ORAL
Constan
C
ORAL
40 mg/day
150 mg/day
5 mg/day
0.25 mg/day
1 mg/day
1.2 mg/day
Date:08/13/03ISR Number: 4167012-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE02967
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Morphoea
15mg/day
Date:08/13/03ISR Number: 4169430-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030707380
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abnormal Behaviour
Akathisia
Insomnia
Logorrhoea
Mania
Study
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
Psychomotor Hyperactivity
DAY, ORAL
Date:08/15/03ISR Number: 4169436-0Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Methylphenidate 10mg
Methadone 10 Mg
PS
SS
Parmed
Roxane
Product
Role
Manufacturer
Medication Error
Nausea
Methadone
Hydrochloride
PS
Roxane
Tremor
Vomiting
Methylphenidate
Hydrochloride
SS
Apothecon
Medication Error
PT
Company Report #USP 50803
Report Source
Duration
TABLET 5MG
TABLET 5MG
18-Aug-2005
Page: 389
Route
Duration
Date:08/15/03ISR Number: 4169469-4Report Type:Direct
Age:61 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
Company Report #USP 50592
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/15/03ISR Number: 4170193-2Report Type:Direct
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
TABLET
PT
Company Report #USP 50139
Report Source
Product
Role
Manufacturer
Blood Glucose Decreased
Ritalin
PS
Ciba
Brain Damage
Glynase
SS
Pharmacia And Upjohn
Product
Role
Manufacturer
Cardiac Disorder
Cardio-Respiratory Arrest
Ritalin
PS
Novartis Sector:
Pharma
Leg Amputation
Sudden Death
Ritalin
SS
Novartis Sector:
Pharma
Wound Infection
Mirtazapine
C
Route
Duration
TABLET
Coma
Convulsion
Medication Error
Mental Retardation
Severity Unspecified
Date:08/18/03ISR Number: 4169310-XReport Type:Expedited (15-DaCompany Report #PHEH2003US06788
Age:
Gender:Male
I/FU:F
Outcome
Dose
Duration
Death
Hospitalization 80 mg, UNK
Initial or Prolonged
PT
Report Source
Route
60 mg, UNK
Date:08/18/03ISR Number: 4173742-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030801274
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Attention
Deficit/Hyperactivity
Disorder
Condition Aggravated
Hypomania
Foreign
Health
Professional
Concerta Xl
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
18 MG, 1 IN 1
DAY, ORAL
Ritalin
(Methylphenidate
ORAL
Hydrochlorde)
C
Date:08/20/03ISR Number: 4171016-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE03032
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Aggression
Blister
Dependence
Depression
Heart Rate Increased
Renal Pain
Date:08/20/03ISR Number: 4172195-9Report Type:Direct
Age:13 YR
Gender:Female
I/FU:I
Outcome
Hospitalization Initial or Prolonged
Required
Intervention to
Prevent Permanent
Impairment/Damage
18-Aug-2005
Page: 390
11:49 AM
PT
Anorexia
Asthenia
Blood Creatinine
Increased
Blood Urea Increased
Cachexia
Disturbance In Attention
Report Source
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Pharma
Company Report #CTU 200270E
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Stress
Weight Decreased
Report Source
Dose
Product
Role
Manufacturer
Route
Concerta 36 Mg
PS
ORAL
Strattera 40 Mg
SS
ORAL
Duration
36 MG ONCE A
DAY ORAL
40 MG ONCE A
DAY ORAL
Date:08/20/03ISR Number: 4172973-6Report Type:Direct
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 200336
Report Source
Product
Role
Metadate Cd - 20 Mg
Tabs
PS
Manufacturer
Route
Duration
Aggression
Anger
ORAL
3 TABS PO Q
AM
Date:08/21/03ISR Number: 4173428-5Report Type:Direct
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 200455
Report Source
Product
Role
Methylphenidate Sr
20 Mg
PS
Manufacturer
Route
Duration
Aggression
Drug Ineffective
20 MG PO AT 4
Impulse-Control Disorder
PM
Psychomotor Hyperactivity
Theft
Date:08/25/03ISR Number: 4177638-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030803159
Age:18 YR
Gender:Male
I/FU:I
ORAL
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abdominal Discomfort
Agitation
Disturbance In Attention
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Medikinet (Tablets)
Methylphenidate
Hydrochloride
C
18 MG, 1 IN 1
Miosis
DAY, ORAL
Restlessness
Tachycardia
Date:08/26/03ISR Number: 4173418-2Report Type:Expedited (15-DaCompany Report #PHBS2003JP06515
Age:89 YR
Gender:Female
I/FU:F
Outcome
Death
Other
18-Aug-2005
Page: 391
PT
Asthenia
Blood Pressure Decreased
Body Temperature
Increased
C-Reactive Protein
Eating Disorder
Hallucination, Visual
Mental Impairment
Nausea
Pneumonia Aspiration
Po2 Decreased
Respiratory Distress
Somnolence
Suicidal Ideation
Tremor
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
White Blood Cell Count
Report Source
Dose
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Duration
10 mg/day
69120MIN
150 mg/day
34560MIN
100 mg/day
23040MIN
50 mg/day
11520MIN
25 mg/day
57600MIN
5 mg/day
11520MIN
Symmetrel
SS
ORAL
Symmetrel
SS
ORAL
Gramalil
C
ORAL
Gramalil
C
ORAL
Myslee
C
ORAL
Vitaject
C
Hicaliq
C
Glucose
C
Mineralin
C
Amiparen
C
INTRAVENOUS
INTRAVENOUS
INTRAVENOUS
INTRAVENOUS
INTRAVENOUS
Date:08/27/03ISR Number: 4180718-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030704702
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Cardiac Flutter
Chest Pain
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Manufacturer
Route
Duration
18 MG, 1 IN 1
DAY, ORAL
Neoclarityn
(Desloratadine)
Unknown
Salbutamol
(Salbutamol)
C
ORAL
Inhalation
C
Date:08/27/03ISR Number: 4180725-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030704702
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Cardiac Flutter
Chest Pain
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
18 MG, 1 IN 1
DAY, ORAL
Neoclarityn
(Desloratadine)
Unknown
Salbutamol
(Salbutamol)
Inhalation
Date:08/28/03ISR Number: 4175016-3Report Type:Expedited (15-DaCompany Report #PHNR2003AU01172
Age:
Gender:Female
I/FU:F
Outcome
Other
18-Aug-2005
Page: 392
Manufacturer
Route
Duration
PT
Anaemia
Anxiety
Drug Interaction
Fatigue
Heart Rate Irregular
Lethargy
11:49 AM
C
C
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Nausea
Palpitations
Pruritus
Dose
Report Source
Product
Role
Manufacturer
Route
Ritalin La
PS
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Duration
Somnolence
40 mg, QD,
mane
Ritalin La
SS
2 capsules, 1
in am, 1 in
pm
Ritalin La
SS
40 mg, QD,
mane
Tegretol
200 mg
SS
ORAL
2880 MIN
Date:08/28/03ISR Number: 4175021-7Report Type:Expedited (15-DaCompany Report #PHNR2003AU01176
Age:
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritalin La
PS
Novartis Sector:
Pharma
ORAL
Duration
Drug Ineffective
Increased Appetite
30 mg, QD,
mane
Catapres
C
Ventolin
C
Flixotide
C
Unspecified
Unspecified
Unspecified
Date:08/28/03ISR Number: 4182101-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030804648
Age:7 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Gastrooesophageal Reflux
Disease
Vomiting
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:08/29/03ISR Number: 4175821-3Report Type:Expedited (15-DaCompany Report #PHBS2003ZA09019
Age:12 YR
Gender:Unknown
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Ritalin
PS
Novartis Sector:
Pharma
Manufacturer
Route
Duration
Sudden Death
UNKNOWN
Date:08/29/03ISR Number: 4182478-4Report Type:Expedited (15-DaCompany Report #2003UW10598
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Dysphagia
Hallucination
Respiratory Arrest
Health
Professional
Iressa
Iressa
Baclofen
PS
SS
SS
Clonidine
SS
Methylphenidate
SS
START DATE IS
PRIOR TO
02-AUG-2003
START DATE IS
PRIOR TO
02-AUG-2003
START DATE IS
PRIOR TO
18-Aug-2005
Page: 393
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
02-AUG-2003
Lorazepam
SS
Zoloft
SS
Benadryl
SS
START DATE IS
PRIOR TO
02-AUG-2003
START DATE IS
PRIOR TO
02-AUG-2003
START DATE IS
PRIOR TO
02-AUG-2003
Date:08/29/03ISR Number: 4202553-5Report Type:Periodic
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #NSADSS2003024795
PT
Report Source
Product
Role
Abdominal Pain
Anorexia
Weight Decreased
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
18 MG, 1 IN 1
DAY, ORAL
Qvar (Beclometasone
Dipropionate)
Albuterol
(Salbutamol)
Motrin (Ibuprofen)
Claritin
(Loratadine)
Date:08/29/03ISR Number: 4202554-7Report Type:Periodic
Age:12 YR
Gender:Male
I/FU:I
C
C
C
C
Company Report #US-JNJFOC-20030706262
ORAL
Outcome
Dose
Other
PT
Report Source
Product
Role
Convulsion
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Manufacturer
Route
Duration
54 MG, 1 IN 1
DAY
Date:08/29/03ISR Number: 4202555-9Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #US-JNJFOC-20030600089
PT
Report Source
Product
Role
Growth Retardation
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
ORAL
ORAL
Date:09/02/03ISR Number: 4176974-3Report Type:Expedited (15-DaCompany Report #PHNR2003AU01199
Age:16 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Anxiety
Tachycardia
30 mg, QD,
mane
18-Aug-2005
Page: 394
Report Source
Product
Role
Manufacturer
Route
Ritalin La
PS
Novartis Sector:
Pharma
ORAL
Duration
2880 MIN
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/02/03ISR Number: 4177207-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE01527
Age:15 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Cerebral Haemorrhage
Coagulopathy
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Disseminated
Ritalin-Sr
Duration
.5 DF, QD
SS
ORAL
1 DF, QD
Intravascular Coagulation
Haemorrhage
Injury
Nervous System Disorder
Skin Haemorrhage
Date:09/02/03ISR Number: 4177208-6Report Type:Expedited (15-DaCompany Report #PHRM2002FR02903
Age:9 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
20 mg/day
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain
Arthralgia
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Inflammation
Pyelonephritis Chronic
Ritaline
Novartis Sector:
Pharma
ORAL
Pyrexia
Rash Macular
Ritaline
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
SS
30 mg/day
SS
20 mg/day
Urinary Tract Infection
Vomiting
Weight Decreased
Date:09/02/03ISR Number: 4178575-XReport Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
1-1/2-1/2
PT
Company Report #CTU 201140
Report Source
Product
Role
Generic Ritalin 20
Mg
PS
Duration
Drug Ineffective
Pharmaceutical Product
ORAL
Complaint
ORAL
Weight Decreased
Generic Ritalin 5 Mg
SS
ORAL
Q-1-1 ORAL
Weight Increased
Date:09/02/03ISR Number: 4183468-8Report Type:Expedited (15-DaCompany Report #NSADSS2003024795
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abdominal Pain Upper
Anorexia
Hyperphagia
Weight Decreased
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
SEE IMAGE
Qvar (Beclometasone
Dipropionate)
Albuterol
(Salbutamol)
Motrin (Ibuprofen)
Claritin
(Loratadine)
18-Aug-2005
Page: 395
Manufacturer
Route
Duration
11:49 AM
C
C
C
C
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/02/03ISR Number: 4184810-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030603419
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Fall
Skin Haemorrhage
Thrombocytopenia
Foreign
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Medikinet Tablets)
Methylphenidate
Hydrochloride
C
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
1
TABLET/DAILY
Date:09/03/03ISR Number: 4184946-8Report Type:Expedited (15-DaCompany Report #CEL-2003-03092-ROC
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Cerebrovascular Accident
Coma
Medication Error
Poisoning
Somnolence
Consumer
Methylphenidate
Tablets
(Unspecified)
(Methylphenidate
Hydrochloride)
Methadone
(Methadone)
Date:09/04/03ISR Number: 4179809-8Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Role
PS
SS
Company Report #CTU 201285
Report Source
Product
Role
Ritalin
PS
Duration
Drug Ineffective
10 MG #90
Pharmaceutical Product
Complaint
Date:09/04/03ISR Number: 4181198-XReport Type:Direct
Age:88 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #USP 042257
Report Source
Product
Role
Methylphenidate 5 Mg
Metolazone
PS
SS
Manufacturer
Route
Manufacturer
Route
Duration
Agitation
Aphonia
Confusional State
Disorientation
Medication Error
Date:09/04/03ISR Number: 4183795-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030603419
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Bleeding Time Prolonged
Fall
Haematoma
Petechiae
Skin Haemorrhage
Foreign
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Medikinet (Tablets)
Methylphenidate
Hydrochloride
C
1
Thrombocytopenia
TABLET/DAILY
18-Aug-2005
Page: 396
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/04/03ISR Number: 4185071-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030805307
Age:2 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Apathy
Mydriasis
Tachycardia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
18 MG, 1 IN 1
DAY, ORAL
Date:09/05/03ISR Number: 4180647-0Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 201336
Report Source
Drug Ineffective
10 MG
Product
Role
Ritalin
PS
Manufacturer
Route
Route
Duration
#90
Pharmaceutical Product
Complaint
Date:09/08/03ISR Number: 4181062-6Report Type:Expedited (15-DaCompany Report #PHBS2003ZA09019
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Ritalin
PS
Novartis Sector:
Pharma
Budesonide
C
Flixonase
C
Inflammide
C
Duration
UNKNOWN
Circulatory Collapse
Sudden Death
20 mg/d
90
DAY
UNKNOWN
50
microgram/d
UNKNOWN
UNKNOWN
73
DAY
Date:09/08/03ISR Number: 4186487-0Report Type:Expedited (15-DaCompany Report #NSADSS2002033023
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Conversion Disorder
Dystonia
Tonic Clonic Movements
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
ORAL
18 MG, 1 IN 1
DAY, ORAL
Singulair
(Montelukast Sodium)
Phenergan
(Promethazine
Hydrochloride)
C
C
Date:09/08/03ISR Number: 4186488-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030604709
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abnormal Behaviour
Dyskinesia
Flushing
Muscle Twitching
Nausea
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
54 MG, 1 IN 1
Tic
DAY, ORAL
18-Aug-2005
Page: 397
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/09/03ISR Number: 4181251-0Report Type:Expedited (15-DaCompany Report #PHNR2003AU01252
Age:14 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Route
Duration
Androgens Increased
Drug Ineffective
1 tablet
Muscle Twitching
morning and
Tremor
noon
Vision Blurred
Zoloft
C
Risperidone
C
Seroquel
C
Unspecified
Unspecified
Unspecified
Date:09/09/03ISR Number: 4184756-1Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 201447
Report Source
Product
Role
Ritalin
PS
Duration
Drug Ineffective
10 MG #90
Pharmaceutical Product
Complaint
Date:09/10/03ISR Number: 4183089-7Report Type:Expedited (15-DaCompany Report #PHBS2003US09314
Age:82 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
5 mg, BID
PT
Report Source
Product
Role
Manufacturer
Methylphenidate
PS
Novartis Sector:
Pharma
Methylphenidate
SS
Novartis Sector:
Pharma
Donepezil
C
Duration
Obsessive-Compulsive
Disorder
20160MIN
10 mg, BID
Date:09/10/03ISR Number: 4183095-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB03421
Age:6 HR
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Drug Exposure During
Pregnancy
Ritaline
PS
Novartis Sector:
Pharma
Neonatal Respiratory
Distalgesic "Lilly"
C
Route
Duration
TRANSPLACENTAL
TRANSPLACENTAL
Distress Syndrome
Premature Baby
Date:09/10/03ISR Number: 4183098-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB03494
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Pharma
Duration
Bradycardia Foetal
Caesarean Section
TRANSPLACENTAL
Drug Exposure During
Pregnancy
Date:09/10/03ISR Number: 4183112-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB01311
Age:14 YR
Gender:Male
I/FU:F
Outcome
Disability
18-Aug-2005
Page: 398
PT
Cyanosis
Echocardiogram Abnormal
Livedo Reticularis
Pain In Extremity
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Peripheral Coldness
Poor Peripheral
Circulation
Dose
Report Source
Product
Role
Manufacturer
Route
Raynaud'S Phenomenon
Tachycardia
Ritalin-Sr
PS
Novartis Sector:
Pharma
ORAL
Ventricular Septal Defect
Ritalin-Sr
SS
Lactulose
C
Duration
20mg/day
20160MIN
40mg/day
Novartis Sector:
Pharma
10080MIN
ORAL
10-20ml/BID/P
RN
Date:09/10/03ISR Number: 4188648-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030600551
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Intentional Misuse
Medication Error
Literature
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
NASAL
INTRA-NASAL
Date:09/10/03ISR Number: 4188649-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030600552
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Intentional Misuse
Literature
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
SEE IMAGE
Date:09/10/03ISR Number: 4188660-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030600491
Age:
Gender:
I/FU:I
NASAL
Outcome
Dose
Other
PT
Report Source
Product
Role
Intentional Misuse
Literature
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
NASAL
INTRA-NASAL
Date:09/11/03ISR Number: 4183882-0Report Type:Expedited (15-DaCompany Report #PHBS2003ZA09019
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
UNKNOWN
UNKNOWN
PT
Report Source
Product
Role
Manufacturer
Ritalin
PS
Novartis Sector:
Pharma
Budesonide
C
Flixonase
C
Inflammide
C
Duration
Brain Oedema
Circulatory Collapse
20 mg/d
90
DAY
Sudden Death
50
microgram/d
UNKNOWN
UNKNOWN
18-Aug-2005
Page: 399
73
11:49 AM
DAY
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/11/03ISR Number: 4189714-9Report Type:Direct
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #USP 042095
Report Source
Product
Role
Manufacturer
Ritalin
PS
Md Pharmaceut
Ritalin
SS
Md Pharmaceut
Product
Role
Manufacturer
Ritalin
PS
Novartis Sector:
Pharma
Route
Duration
Medication Error
TABLET
TABLET
Date:09/15/03ISR Number: 4186451-1Report Type:Expedited (15-DaCompany Report #PHEH2003US07979
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Route
Duration
Diabetes Mellitus
Insulin-Dependent
UNK/UNK
Date:09/15/03ISR Number: 4190633-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030603419
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Bleeding Time Prolonged
Blood Glucose Increased
Fall
Glucose Urine Present
Haematoma
Foreign
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Medikinet
(Methylphenidate
Hydrochloride)
Tablets
C
Manufacturer
1
Mouth Haemorrhage
TABLET/DAILY.
Nasopharyngitis
Oral Mucosal Petechiae
Petechiae
Skin Haemorrhage
Thrombocytopenia
Date:09/16/03ISR Number: 4187008-9Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0409645A
Age:7 YR
Gender:Male
I/FU:F
Route
Outcome
Dose
Duration
Hospitalization 12
DAY
Initial or Prolonged
5MG At night
Other
22
DAY
PT
Report Source
Product
Role
Manufacturer
Route
Aggression
Paxil Cr
PS
Glaxosmithkline
ORAL
Drug Interaction
Zyprexa
SS
ORAL
Excoriation
Metadate
SS
ORAL
Hallucination
Concerta
C
ORAL
36MG Twice
Hallucination, Auditory
per day
Laceration
Nightmare
Psychotic Disorder
Self Mutilation
Date:09/16/03ISR Number: 4190693-9Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #USP 080683
Report Source
Product
Role
Manufacturer
Ritalin
PS
Ciba
Ritalin Sr
SS
Ciba
Duration
Medication Error
TABLET
TABLET,
EXTENDED
RELEASE
18-Aug-2005
Page: 400
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/16/03ISR Number: 4190912-9Report Type:Direct
Age:
Gender:Not SpecifiI/FU:I
Outcome
Dose
PT
Company Report #USP 080533
Report Source
Product
Role
Manufacturer
Route
Ritalin
PS
Md Pharmaceutical
Methylphenidate
SS
Md Pharmaceutical
Product
Role
Manufacturer
Ritalin
PS
Ciba
Ritalin
SS
Ciba
Product
Role
Manufacturer
Route
Methylphenidate 20
Mg Sr
PS
Methylphenidate 20
Mg
SS
Manufacturer
Route
Duration
Medication Error
TABLET
20MG TABLET
Date:09/16/03ISR Number: 4191180-4Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #USP 080618
Report Source
Route
Duration
Medication Error
TABLET
TABLET
Date:09/16/03ISR Number: 4192712-2Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #USP 080648
Report Source
Duration
Medication Error
TAB ,
EXTENDED
RELEASE
TAB
Date:09/16/03ISR Number: 4192896-6Report Type:Direct
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Company Report #CTU 201942
Report Source
Product
Role
Other
(75 LBS) 36
Anorexia
Concerta 36 Mg
PS
Advair
C
ORAL
MG ORAL
Date:09/17/03ISR Number: 4188691-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE01337
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
365
PT
Report Source
Product
Role
Manufacturer
Activated Partial
Thromboplastin Time
Ritaline
PS
Novartis Sector:
Pharma
Prolonged
Antibody Test Positive
Antinuclear Antibody
Positive
Von Willebrand'S Disease
Ritaline
SS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Route
Duration
DAY
Date:09/17/03ISR Number: 4191788-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030901965
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
27 MG, 1 IN 1
DAY, ORAL
18-Aug-2005
Page: 401
PT
Report Source
Product
Role
Anger
Intentional Self-Injury
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/17/03ISR Number: 4192841-3Report Type:Expedited (15-DaCompany Report #CEL-2003-01127-ROC
Age:7 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Aggression
Anxiety
Blood Glucose
Health
Professional
Metadate Er
(Methylphenidate
Hydrochloride)
PS
ORAL
Zyprexa
(Olanzapine)
SS
ORAL
Paxil Cr
(Paroxetine
Hydrochloride)
SS
ORAL
Concerta
(Methylphenidate
Hydrochloride)
SS
ORAL
20 MG (20 MG,
Blood Thyroid Stimulating
DAILY AT 3
Hormone
PM), PO
Depression
Dissociation
5 MG (5 MG,
Excoriation
HS), PO
Haematocrit
Haemoglobin
Hallucination
12.5 MG (12.5
Hallucination, Auditory
MG, IN THE
Laceration
MORNING), PO
Nightmare
Platelet Count Increased
Psychotic Disorder
72 MG (72 MG,
Red Blood Cell Count
IN THE
Self Mutilation
MORNING)
White Blood Cell Count
Date:09/17/03ISR Number: 4193520-9Report Type:Expedited (15-DaCompany Report #PHBS2003ZA0919
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
20 MG/D,
PT
Report Source
Product
Role
Brain Oedema
Circulatory Collapse
Speech Disorder
Foreign
Health
Professional
Ritalin(Methylphenid
ate Hydrochloride)
Unknown
PS
Duration
Manufacturer
Route
Sudden Death
Company
UNKNOWN
Representative
Other
Budesonide
Flixonase
Inflammide
C
C
C
Date:09/17/03ISR Number: 4193535-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB01311
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Disability
SEE IMAGE
PT
Report Source
Product
Role
Cyanosis
Echocardiogram Abnormal
Livedo Reticularis
Pain In Extremity
Foreign
Health
Professional
Other
Ritalin-Sr(Methylphe
nidate
Hydrochloride) Slow
Release Tablet
PS
Lactulose
C
Duration
74
DAY
Peripheral Coldness
Pharmaceutical Product
Complaint
Poor Peripheral
Circulation
Raynaud'S Phenomenon
Tachycardia
Ventricular Septal Defect
Date:09/19/03ISR Number: 4189237-7Report Type:Expedited (15-DaCompany Report #PHBS2003JP06515
Age:89 YR
Gender:Female
I/FU:F
Outcome
Death
Other
18-Aug-2005
Page: 402
PT
Blood Pressure Decreased
C-Reactive Protein
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Eating Disorder
Hallucination
Hallucination, Visual
Dose
Report Source
Product
Role
Manufacturer
Route
Mental Impairment
Nausea
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Pneumonia Aspiration
Symmetrel
SS
ORAL
Po2 Decreased
Symmetrel
SS
ORAL
Pyrexia
Gramalil
C
ORAL
Respiratory Distress
Gramalil
C
ORAL
Somnolence
Myslee
C
ORAL
Tremor
Vitaject
C
White Blood Cell Count
Hicaliq
C
Glucose
C
Mineralin
C
Amiparen
C
Duration
10 mg/day
69120MIN
150 mg/day
34560MIN
100 mg/day
23040MIN
50 mg/day
11520MIN
25 mg/day
57600MIN
5 mg/day
11520MIN
INTRAVENOUS
INTRAVENOUS
INTRAVENOUS
INTRAVENOUS
INTRAVENOUS
Date:09/22/03ISR Number: 4189437-6Report Type:Expedited (15-DaCompany Report #PHEH2003US05548
Age:41 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
5 mg, QD
PT
Report Source
Product
Role
Manufacturer
Route
Arterial Occlusive
Disease
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Chest Pain
Myocardial Infarction
Levothyroxine
Prozac
C
C
Date:09/22/03ISR Number: 4194070-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030600469
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Alanine Aminotransferase
Anaemia
Aspartate
Aminotransferase
Blood Albumin
Consumer
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Crohn'S Disease
Decreased Appetite
Defaecation Urgency
Fatigue
Haemoglobin
Headache
Inflammatory Bowel
Disease
Insomnia
Lipoma
Liver Function Test
Abnormal
Rectal Haemorrhage
Red Blood Cell
Sedimentation Rate
Somnolence
Weight Decreased
Date:09/23/03ISR Number: 4191752-7Report Type:Expedited (15-DaCompany Report #PHRM2003FR02358
Age:6 YR
Gender:Unknown
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 403
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Colitis
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/23/03ISR Number: 4195122-7Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #USP 08024
Report Source
Product
Role
Methylphenidale 5 Mg
And 10 Mg
PS
Methadone 5 Mg And
10 Mg
SS
Manufacturer
Route
Route
Duration
Medication Error
TAB
TAB
Date:09/23/03ISR Number: 4195230-0Report Type:Direct
Age:
Gender:Not SpecifiI/FU:I
Outcome
Dose
PT
Company Report #USP 080297
Report Source
Product
Role
Manufacturer
Ritalin 10 Mg
Methylphenidate
PS
Ciba
Reglan 10 Mg
Metoclorpamide
SS
Duration
Medication Error
Overdose
10 MG TAB
10 MG TAB
Date:09/23/03ISR Number: 4195296-8Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Other
TABLET
PT
Company Report #USP 080035
Report Source
Product
Role
Methylphenidate
PS
Methyclothiazide
SS
Manufacturer
Route
Manufacturer
Route
Duration
Medication Error
TABLET
Date:09/23/03ISR Number: 4198095-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030903850
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
ORAL
PT
Report Source
Product
Role
Convulsion
Health
Concerta
PS
Duration
Mania
Professional
Date:09/23/03ISR Number: 4198230-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030706439
Age:8 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Blister
Photosensitivity Reaction
Systemic Lupus
Erythematosus
Urticaria
Foreign
Health
Professional
Concerta Xl
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
DAY; ORAL
Date:09/24/03ISR Number: 4192164-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE03424
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Blood Creatine
Phosphokinase Increased
20 mg/day
Date:09/24/03ISR Number: 4192169-1Report Type:Expedited (15-DaCompany Report #PHNU2003DE03430
Age:
Gender:Female
I/FU:I
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 404
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Other
PT
Dose
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Diarrhoea
Palpitations
10 mg, QD
Psychosomatic Disease
Weight Decreased
Date:09/24/03ISR Number: 4193177-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE02967
Age:
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Morphoea
Health
Professional
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
15mg/day
Date:09/24/03ISR Number: 4193179-0Report Type:Expedited (15-DaCompany Report #PHBS2003NO02324
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Confusional State
Hallucination, Visual
Health
Professional
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Duration
10 mg/day
Concerta
UNKNOWN
I
36 mg/day
Date:09/29/03ISR Number: 4197047-XReport Type:Expedited (15-DaCompany Report #PHRM2003FR02358
Age:6 YR
Gender:Unknown
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Colitis
Date:09/29/03ISR Number: 4202430-XReport Type:Expedited (15-DaCompany Report #CEL-2003-02764-ROC
Age:41 YR
Gender:Female
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Agitation
Coma
Intentional Misuse
Oxygen Saturation
Decreased
Pulmonary Oedema
Respiratory Disorder
Somnolence
Stupor
Literature
Health
Professional
Methylphenidate(Meth
ylphenidate)
Methadone
(Methadone)
Cocaine (Cocaine)
Date:09/30/03ISR Number: 4199141-6Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
Role
Route
PT
Route
PS
SS
SS
Company Report #USP 080374
Report Source
Product
Role
Manufacturer
Ritalin
PS
Md Pharmaceutical
Methylphenidate
SS
Duration
Medication Error
TABLET
18-Aug-2005
Page: 405
Manufacturer
Duration
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/01/03ISR Number: 4204360-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030904646
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
Other
PT
Report Source
Product
Role
Systemic Lupus
Erythematosus
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
DAY, ORAL
Date:10/02/03ISR Number: 4199649-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE02965
Age:
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
20mg/day
PT
Report Source
Ear Discomfort
Hypoacusis
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Vertigo
Date:10/02/03ISR Number: 4199694-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE02479
Age:
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Anxiety
Decreased Activity
Ritalin-Sr
PS
Novartis Sector:
Pharma
ORAL
Depression
Telfast
Duration
20 mg, BID
120 mg, QD
20160MIN
Drug Interaction
Hearing Impaired
Hyperacusis
Psychiatric Symptom
Stress
C
ORAL
Date:10/02/03ISR Number: 4199837-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE03439
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Bundle Branch Block Right
Electrocardiogram Qt
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Corrected Interval
Prolonged
Ritaline
Novartis Sector:
Pharma
ORAL
Electrocardiogram Qt
Prolonged
Ritaline
Novartis Sector:
Pharma
ORAL
Duration
5 mg/day
SS
10 mg/day
SS
5 mg/day
Date:10/02/03ISR Number: 4199840-6Report Type:Expedited (15-DaCompany Report #PHRM2003FR02358
Age:6 YR
Gender:Unknown
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
No Adverse Drug Effect
Date:10/03/03ISR Number: 4206150-7Report Type:Expedited (15-DaCompany Report #EMADSS2003001588
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
18-Aug-2005
Page: 406
PT
Report Source
Product
Hallucination, Visual
Foreign
Health
Professional
Concerta
Methylphenidate
Hydrochloride)
Duration
11:49 AM
Role
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Sustained Release
Tablets
PS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
Tablets
SS
ORAL
36 MG, 1 IN 1
DAY, ORAL
10 MG, ORAL
Date:10/03/03ISR Number: 4206152-0Report Type:Expedited (15-DaCompany Report #EMADSS2003001588
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Hallucination, Visual
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
Tablets
SS
ORAL
Duration
36 MG, 1 IN 1
DAY, ORAL
10 MG, ORAL
Date:10/03/03ISR Number: 4206153-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030906118
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Alanine Aminotransferase
Increased
Aspartate
Aminotransferase
Increased
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
36 MG, 1 IN 1
Blood Lactate
DAY, ORAL
Dehydrogenase Increased
ORAL
Gamma-Glutamyltransferase
Increased
Date:10/03/03ISR Number: 4206154-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030906118
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
36 MG, 1 IN 1
PT
Report Source
Product
Role
Alanine Aminotransferase
Foreign
Concerta
PS
Increased
Health
Aspartate
Aminotransferase
Increased
Blood Lactate
Dehydrogenase Increased
Gamma-Glutamyltransferase
Increased
Professional
DAY, ORAL
Date:10/07/03ISR Number: 4206077-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE03439
Age:9 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 407
PT
Bundle Branch Block Right
Electrocardiogram Qt
Corrected Interval
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Prolonged
Electrocardiogram Qt
Prolonged
Dose
Report Source
Product
Role
Foreign
Health
Professional
Other
Ritaline
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Duration
ORAL
5 MG/DAY,
ORAL; 10
MG/DAY, ORAL;
5 MG/DAY,
ORAL
Date:10/07/03ISR Number: 4207598-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030906286
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Dyspnoea
Influenza Like Illness
Foreign
Health
Professional
Concerta Xl
(Methylphenidate
Hydrochloride)
Sustained
PS
Ritalin
(Methylphenidate
Hydrochloride)
C
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
DAY, ORAL
Date:10/08/03ISR Number: 4203694-9Report Type:Expedited (15-DaCompany Report #PHRM2003FR02631
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
40 mg/day
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Hepatitis
Date:10/08/03ISR Number: 4206134-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE02479
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Decreased Activity
Depression
Drug Interaction
Foreign
Health
Professional
Ritalin-Sr(Methylphe
nidate
Hydrochloride)Tablet
PS
Hyperacusis
Other
Telfast
(Fexofenadine)
Film-Coated Tablet
C
Manufacturer
Route
Duration
ORAL
20 MG, BID,
ORAL
Mental Impairment
Stress
Date:10/08/03ISR Number: 4206258-6Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #USP 080109
Report Source
Product
Role
Manufacturer
Ritalin Sr 20
PS
Ciba
Ritalin 20 Mg
SS
Ciba
Duration
Medication Error
TAB
TAB
18-Aug-2005
Page: 408
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/08/03ISR Number: 4207859-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030906368
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
72 MG, IN 1
PT
Report Source
Product
Role
Aggression
Anxiety
Blood Glucose
Health
Professional
Concerta
(Methylphenidate
Hydrochloride) S R
PS
Zyprexa (Olanzapine)
SS
Paxil Cr (Paroxetine
Hydrochloride)
SS
Metadate Er
(Methylphenidate)
SS
Manufacturer
Route
Blood Thyroid Stimulating
DAY
Hormone
5 MG, 1 IN 1
Depression
DAY
Excoriation
Haematocrit
12.5 MG, 1 IN
Haemoglobin
1 DAY
Hallucination, Auditory
Initial Insomnia
20 MG, 1 IN 1
Laceration
DAY
Nightmare
Platelet Count Increased
Psychotic Disorder
Red Blood Cell Count
Refusal Of Treatment By
Relative
Self Mutilation
White Blood Cell Count
Date:10/08/03ISR Number: 4208733-7Report Type:Direct
Age:20 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Manufacturer
Route
Concerta
PS
Mcneil
ORAL
Duration
Dizziness
2 TAB BY
Dyspnoea
MOUTH IN
Ear Pain
MORNING
Company Report #CTU 203517
Glossodynia
Headache
Lymphadenopathy
Swollen Tongue
Tongue Disorder
Trileptal
Piroxicam
Clonidine Hcl
Zoloft
C
C
C
C
Date:10/09/03ISR Number: 4205158-5Report Type:Expedited (15-DaCompany Report #PHEH2003US06719
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
20 mg, QD
PT
Report Source
Product
Role
Manufacturer
Route
Balance Disorder
Dysarthria
Ritalin La
PS
Novartis Sector:
Pharma
ORAL
Mood Swings
Musculoskeletal Stiffness
Posture Abnormal
Flonase
Montelukast Sodium
Duration
38880MIN
C
C
Date:10/10/03ISR Number: 4206183-0Report Type:Expedited (15-DaCompany Report #PHBS2003JP10909
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Duration
Drug Dependence
60 mg/day
Ludiomil
C
ORAL
Paxil
C
ORAL
50 mg/day
4 mg/day
18-Aug-2005
Page: 409
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/10/03ISR Number: 4209062-8Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20031000841
Age:11 YR
Gender:
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Cold Sweat
Hyperhidrosis
Palpitations
Panic Attack
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Luvox (Fluvoxamine
Maleate)
C
Manufacturer
Route
ORAL
1 IN 1 DAY,
ORAL
Date:10/10/03ISR Number: 4209921-6Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #USP 080710
Report Source
Product
Role
Manufacturer
Ritalin
PS
Ciba Geigy
Ritalin
SS
Ciba Geigy
Route
Duration
Medication Error
TABLET
TABLET
Date:10/15/03ISR Number: 4208728-3Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0311627A
Age:7 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
UNKNOWN
PT
Report Source
Product
Role
Manufacturer
Amoxycillin
PS
Glaxosmithkline
Concerta
SS
Melatonin
C
Duration
times per day
UNKNOWN
Attention
5ML Four
Deficit/Hyperactivity
7
DAY
Disorder
36MG Per day
Condition Aggravated
3MG Twice per
Drug Interaction
day
Intentional Self-Injury
Route
Date:10/15/03ISR Number: 4208983-XReport Type:Expedited (15-DaCompany Report #PHBS2003ZA09019
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
UNKNOWN
UNKNOWN
PT
Report Source
Product
Role
Manufacturer
Ritalin
PS
Novartis Sector:
Pharma
Budesonide
C
Lung Disorder
Flixonase
C
Sudden Death
Inflammide
C
Route
Duration
Brain Oedema
Circulatory Collapse
20 mg/d
Fall
50
Inflammation
microgram/d
UNKNOWN
UNKNOWN
Date:10/15/03ISR Number: 4210983-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031000797
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
SEE IMAGE
18-Aug-2005
Page: 410
PT
Report Source
Product
Role
Growth Retardation
Weight Decreased
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/15/03ISR Number: 4213606-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030603419
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Fall
Haematoma
Petechiae
Thrombocytopenia
Foreign
Consumer
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Medikinet
(Methylphenidate
Hydrochloride)
Tablets
C
Manufacturer
Route
Manufacturer
Route
1
TABLET/DAILY.
Date:10/17/03ISR Number: 4214621-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030705720
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Anxiety
Gastrooesophageal Reflux
Disease
Ulcer
Vomiting
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
ORAL
SEE IMAGE
Date:10/20/03ISR Number: 4211945-XReport Type:Expedited (15-DaCompany Report #PHNU2003DE03424
Age:5 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Blood Creatine
Phosphokinase Increased
20 mg/day
Date:10/20/03ISR Number: 4211947-3Report Type:Expedited (15-DaCompany Report #PHBS2003ZA09019
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Arrhythmia
Brain Oedema
Ritalin La
PS
Novartis Sector:
Pharma
ORAL
Circulatory Collapse
Budesonide
C
Flixonase
Inflammide
C
C
Ventolin
C
Duration
20 mg/day
UNKNOWN
50
Sudden Death
microgram/d
NASAL
200 ug, BID
UNKNOWN
one or twice
every three
months
Date:10/20/03ISR Number: 4214877-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031002540
Age:45 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Myocardial Infarction
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Vioxx (Rofecoxib)
C
ORAL
18-Aug-2005
Page: 411
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/21/03ISR Number: 4215874-7Report Type:Expedited (15-DaCompany Report #HQWYE149510OCT03
Age:20 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
150 MG 1X PER
PT
Report Source
Product
Role
Manufacturer
Route
Confusional State
Drug Interaction
Feeling Hot
Health
Professional
Other
Efexor (Venlafaxine
Hydrochloride,
Tablet)
PS
ORAL
Bexin
(Dextromethorphan
Hydrobromide, )
SS
ORAL
Nemexin (Naltrexone
Hydrochloride, )
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride, )
SS
ORAL
Sinquan (Doxepin
Hydrochloride, )
SS
ORAL
Vertigo
1 DAY
25 MG 1X PER
1 DAY
1
DAY
100 MG 1X PER
1 DAY
60 MG 1X PER
1 DAY
50 MG 1X PER
1 DAY
Date:10/21/03ISR Number: 4215945-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031002658
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Asthenia
Blood Lactate
Dehydrogenase Increased
Gamma-Glutamyltransferase
Increased
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
36 MG, 1 IN 1
ORAL
DAY, ORAL
Date:10/21/03ISR Number: 4215950-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031002658
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Asthenia
Blood Lactate
Dehydrogenase Increased
Gamma-Glutamyltransferase
Increased
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
DAY, ORAL
Date:10/22/03ISR Number: 4215399-9Report Type:Direct
Age:26 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 204306
Report Source
Product
Role
Methylphenidate
PS
Duration
Agitation
Date:10/23/03ISR Number: 4215648-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE02479
Age:
Gender:Male
I/FU:F
Outcome
Other
18-Aug-2005
Page: 412
PT
Anxiety
Decreased Activity
Delusion
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Depression
Drug Ineffective
Drug Interaction
Dose
Report Source
Product
Role
Manufacturer
Route
Ritalin-Sr
PS
Novartis Sector:
Pharma
ORAL
Duration
Hearing Impaired
Stress
20 to 40
mg/day
Telfast
120 mg, QD
SS
ORAL
20160MIN
Date:10/23/03ISR Number: 4215650-5Report Type:Expedited (15-DaCompany Report #PHNU2003DE01089
Age:7 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Manufacturer
Route
Duration
Autoimmune Thyroiditis
Blood Thyroid Stimulating
10mg-0-5mg/da
Hormone Increased
y
Hypothyroidism
Thyroid Atrophy
Date:10/23/03ISR Number: 4224064-3Report Type:Expedited (15-DaCompany Report #CEL-2003-03447-ROC
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Stevens-Johnson Syndrome
Health
Professional
Methylphenidate Er
Tablets (Strength
Unspecified)
(Methlphenidate
Hydrochloride)
PS
Date:10/24/03ISR Number: 4219241-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031001855
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Other
Contusion
Rash Pruritic
Foreign
Health
Professional
Concerta Xl
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
SEE IMAGE
Date:10/24/03ISR Number: 4219464-1Report Type:Expedited (15-DaCompany Report #DK-JNJFOC-20031003529
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Depression
Psychiatric Symptom
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
54 MG, 1 IN 1
DAY,
Date:10/24/03ISR Number: 4219467-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031003840
Age:7 YR
Gender:Female
I/FU:I
Outcome
Other
18-Aug-2005
Page: 413
PT
Abnormal Behaviour
Attention
Deficit/Hyperactivity
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Disorder
Condition Aggravated
Disturbance In Attention
Drug Interaction
Dose
Report Source
Product
Role
Foreign
Health
Professional
Concerta Xl
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Amoxycillin
(Amoxicillin)
SS
Melatonin
(Melatonin)
C
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
36 MG, 1 IN 1
DAY,
5 ML, 4 IN 1
DAY,
Date:10/24/03ISR Number: 4219667-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031004151
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hepatitis
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
Date:10/24/03ISR Number: 4219674-3Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20031003637
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
18 MG, 1 IN 1
PT
Report Source
Product
Role
Constipation
Gastrointestinal
Obstruction
Foreign
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
DAY, ORAL
Clonidine
(Clonidine) Tablets
C
Date:10/24/03ISR Number: 4219682-2Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20030902595
Age:39 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Alanine Aminotransferase
Aspartate
Aminotransferase
Blood Creatine
Phosphokinase
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Seroxat (Paroxetine
Hydrochloride)
Unknown
C
36 MG, 1 IN 1
Delusion
DAY, ORAL
Hallucination, Auditory
Mania
Psychotic Disorder
Suicide Attempt
18-Aug-2005
Page: 414
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/24/03ISR Number: 4219757-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031003780
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Pica
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Albuterol
(Salbutamol)
C
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:10/24/03ISR Number: 4219774-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031003652
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Stevens-Johnson Syndrome
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:10/24/03ISR Number: 4219794-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031003781
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Sleep Walking
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Wellbutrin
(Bupropion
Hydrochloride)
SS
54 MG, 1 IN 1
DAY, ORAL
150 MG
Manufacturer
Route
Duration
ORAL
Date:10/24/03ISR Number: 4220199-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031004293
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Tourette'S Disorder
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
36 MG, 1 IN 1
DAY
Date:10/27/03ISR Number: 4218853-9Report Type:Expedited (15-DaCompany Report #PHRM2003FR02822
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Abdominal Pain
Gastritis
10 mg/day
Syncope
18-Aug-2005
Page: 415
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/27/03ISR Number: 4221093-0Report Type:Expedited (15-DaCompany Report #2003111995
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization 50 MG, ORAL
Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Confusional State
Foreign
Sinequan (Doxepin)
PS
ORAL
Drug Interaction
Temperature Intolerance
Vertigo
Health
Professional
Dextromethorphan
Hydrobromide
(Bextromethorpahn
Hydrobromide)
SS
ORAL
Venlafaxine
Hydrochloride
(Venlfafaxine
Hydrochloride)
SS
ORAL
Methylpehenidate
Hydrochloride
(Methylphenidate
Hydrochloride)
SS
ORAL
Naltrexone
Hydrochloride
(Naltrexone
Hydrochloride)
SS
ORAL
50 MG, (BID),
ORAL
150 MG, ORAL
60 MG, ORAL
100 MG, ORAL
Date:10/28/03ISR Number: 4219888-2Report Type:Expedited (15-DaCompany Report #PHBS2003ZA09019
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Arrhythmia
Brain Oedema
Ritalin La
PS
Novartis Sector:
Pharma
ORAL
Circulatory Collapse
Budesonide
C
Flixonase
Inflammide
C
C
Duration
20 mg/day
UNKNOWN
50
Sudden Death
microgram/d
200 ug, BID
NASAL
Ventolin
UNKNOWN
C
one or twice
every three
months
Date:10/28/03ISR Number: 4220499-3Report Type:Direct
Age:22 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 204718
Report Source
Product
Role
Methyphenydate Sr 20
Ritalin Manufacturer
PS
Manufacturer
Route
Duration
Drug Ineffective
Pharmaceutical Product
ORAL
2 PO BID, 3-4
Complaint
YRS
Date:10/28/03ISR Number: 4222815-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031002164
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG, 1 IN 1
DAY,ORAL
18-Aug-2005
Page: 416
PT
Report Source
Product
Role
Obsessive-Compulsive
Disorder
Study
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:10/28/03ISR Number: 4222818-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031002164
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abnormal Behaviour
Obsessive-Compulsive
Disorder
Study
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
DAY, ORAL
Date:10/28/03ISR Number: 4223336-6Report Type:Expedited (15-DaCompany Report #CEL-2003-03436-ROC
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Convulsion
Health
Professional
Metadate Cd
(Methylphenite
Hydrochloride)
PS
Ssi (Ssri)
C
Manufacturer
Route
Manufacturer
Route
Duration
60 MG
Date:10/29/03ISR Number: 4221835-4Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 204803
Report Source
Product
Role
Methylphenidate 20
Mg
PS
Duration
Abnormal Behaviour
Aggression
1 1/2 TAB @
Pharmaceutical Product
0800/1200/160
Complaint
0
Psychomotor Hyperactivity
Date:10/29/03ISR Number: 4221837-8Report Type:Direct
Age:51 YR
Gender:Male
I/FU:I
Company Report #CTU 204804
Outcome
Dose
Other
ONE DOSE PO
PT
Report Source
Product
Role
Ritalin 10 Mg
PS
Manufacturer
Route
Duration
Drug Ineffective
ORAL
QID
Date:10/30/03ISR Number: 4224266-6Report Type:Expedited (15-DaCompany Report #KII-2003-0002834
Age:26 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Manufacturer
Route
Abnormal Behaviour
Body Temperature
Increased
Confusional State
Health
Professional
Oxycontin Tablets
(Oxycodone
Hydrochloride) Cr
Tablet
PS
ORAL
Disorientation
Dyslogia
Logorrhoea
Multiple Drug Overdose
Oxycodone
Hydrochloride
(Oxycodone
Hydrochloride)
SS
ORAL
Pain
Tachycardia
Tremor
Promethazine
(Promethazine)
Paregoric (Benzoic
Acid, Camphor, Anise
Oil, Opium)
Protonix
(Pantoprazole)
Ambien (Zolpidem
Tartrate)
ORAL
ORAL
18-Aug-2005
Page: 417
11:49 AM
SS
SS
SS
SS
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Prednisone
(Prednisone)
Amitriptyline
(Amitriptyline)
Strattera
(Atomoxetine)
Ocean Nasal Spray
(Sodium Chloride)
SS
SS
SS
SS
UMOL,
Metronidazole
(Metronidazole)
Methylphenidate
(Methylphenidate)
SS
SS
Date:10/31/03ISR Number: 4224791-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031004165
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abnormal Behaviour
Aggression
Paranoia
Study
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
DAY, ORAL
Date:10/31/03ISR Number: 4225613-1Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20031001540
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG, 1 IN 1
DAY, ORAL
PT
Report Source
Product
Role
Alopecia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tabltes
PS
Manufacturer
Route
Duration
ORAL
Date:10/31/03ISR Number: 4225615-5Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20031005088
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Delusion
Disorientation
Feeling Abnormal
Gastroenteritis Viral
Hallucination
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
ORAL
36 MG, 1 IN 1
Medication Error
DAY, ORAL
Nausea
Overdose
Vomiting
Date:11/03/03ISR Number: 4226107-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20031005987
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
18 MG, ORAL
18-Aug-2005
Page: 418
11:49 AM
PT
Report Source
Product
Role
Hallucination
Medication Error
Psychotic Disorder
Skin Disorder
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/03/03ISR Number: 4226201-3Report Type:Expedited (15-DaCompany Report #NSADSS2002046188
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Cardiac Arrest
Circulatory Collapse
Sudden Cardiac Death
Syncope
Ventricular Tachycardia
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
DAY, ORAL; 36
MG, 1 IN 1
DAY, ORAL
Date:11/04/03ISR Number: 4225361-8Report Type:Expedited (15-DaCompany Report #PHNU2003DE02607
Age:15 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Route
Duration
Amaurosis Fugax
Scotoma
15 mg/day
Date:11/04/03ISR Number: 4225366-7Report Type:Expedited (15-DaCompany Report #PHBS2003CA11766
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
UNKNOWN
PT
Report Source
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Pharma
Dilantin
C
Perseveration
Warfarin
C
Sexual Activity Increased
Losec
C
Colace
C
Duration
Aggression
High Risk Sexual
5 mg, BID
Behaviour
UNKNOWN
UNKNOWN
UNKNOWN
UNKNOWN
Tylenol
UNKNOWN
C
UNK, UNK
Date:11/04/03ISR Number: 4227518-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031004293
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Tourette'S Disorder
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Duration
36 MG, 1 IN 1
DAY
Date:11/06/03ISR Number: 4230649-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031006198
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Mechanical Ileus
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
54 MG, ORAL
Date:11/07/03ISR Number: 4230015-8Report Type:Periodic
Age:
Gender:Female
I/FU:F
Outcome
18-Aug-2005
Page: 419
PT
Drug Interaction
Liver Function Test
11:49 AM
Company Report #US-GLAXOSMITHKLINE-A0392935A
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Abnormal
Road Traffic Accident
Report Source
Dose
Product
Role
Manufacturer
Route
Wellbutrin
PS
Glaxosmithkline
ORAL
Ritalin
SS
Duration
YR
YR
Date:11/10/03ISR Number: 4231205-0Report Type:Expedited (15-DaCompany Report #PHBS2003CA12032
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritalin-Sr
PS
Novartis Sector:
Pharma
ORAL
Duration
Chest Discomfort
Depressed Level Of
Consciousness
Dyspepsia
Glossodynia
Headache
Date:11/12/03ISR Number: 4234039-6Report Type:Direct
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization ORAL
Initial or Prolonged
PT
Company Report #CTU 205842
Report Source
Antibody Test Positive
Product
Role
Manufacturer
Route
Concerta ? J&J
PS
J&J
ORAL
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
Dermatitis Exfoliative
Erythema Multiforme
Penile Ulceration
Skin Depigmentation
Date:11/13/03ISR Number: 4234113-4Report Type:Expedited (15-DaCompany Report #PHBS2003CH05877
Age:8 YR
Gender:Male
I/FU:F
Outcome
PT
Dose
Duration
Hospitalization Abdominal Pain
Initial or Prolonged
Pancreatitis
UNKNOWN
10 mg/day
Report Source
Ritalin
SS
Novartis Sector:
Pharma
Product
Role
Manufacturer
Route
Condition Aggravated
Decreased Appetite
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Nausea
Decortin
C
ORAL
Rheumatoid Arthritis
Methotrexat
C
ORAL
UNKNOWN
Date:11/13/03ISR Number: 4234122-5Report Type:Expedited (15-DaCompany Report #PHNU2003DE03876
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Duration
Unknown
2.5 mg/day
Unknown
Date:11/13/03ISR Number: 4235760-6Report Type:Expedited (15-DaCompany Report #CEL-2003-03659-ROC (0)
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Eye Movement Disorder
Hallucination
Insomnia
Oral Intake Reduced
Consumer
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
ORAL
Paxil (Paroxetine
Hydrochloride)
SS
ORAL
Duration
20 MG (20 MG,
Psychotic Disorder
OAM), PO
Schizophrenia
20 MG (20 MG
18-Aug-2005
Page: 420
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Q HS), PO
Date:11/14/03ISR Number: 4235463-8Report Type:Expedited (15-DaCompany Report #PHEH2003US06984
Age:33 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Alcohol Use
Amnesia
Tegretol
PS
Novartis Sector:
Pharma
Bradyphrenia
Drug Interaction
Tegretol
SS
Novartis Sector:
Pharma
Hallucination
Judgement Impaired
Ritalin
Luvox
SS
SS
Loss Of Consciousness
Luvox
SS
Memory Impairment
Sexual Offence
Theft
Thinking Abnormal
Alcohol
SS
Route
Duration
UNK,UNK
UNK,UNK
UNK,UNK
UNK,UNK
Date:11/17/03ISR Number: 4237033-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031002658
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Asthenia
Blood Lactate
Dehydrogenase Increased
Gamma-Glutamyltransferase
Increased
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
36 MG, 1 IN 1
DAY, ORAL
Date:11/17/03ISR Number: 4237053-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031100962
Age:11 YR
Gender:Male
I/FU:I
ORAL
Outcome
Dose
Duration
Life-Threatening
Other
PT
Report Source
Product
Role
Aggression
Laceration
Suicide Attempt
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
18 MG
Date:11/17/03ISR Number: 4237057-7Report Type:Expedited (15-DaCompany Report #DK-JNJFOC-20031100693
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Malaise
Palpitations
Sinus Tachycardia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
36 MG, 1 IN 1
DAY
Date:11/17/03ISR Number: 4237060-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031100960
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 421
11:49 AM
PT
Report Source
Product
Blood Pressure Decreased
Syncope
Foreign
Health
Professional
Concerta Xl
(Methylphenidate
Hydrochloride)
Role
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Sustained Release
Tablets
PS
36 MG, 1 IN 1
DAY
Date:11/17/03ISR Number: 4237063-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031001518
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Alkaline
Phosphatase Increased
Haemoglobin Decreased
Liver Function Test
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
Abnormal
DAY ORAL
Date:11/18/03ISR Number: 4237721-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20031003652
Age:15 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
ORAL
PT
Report Source
Product
Role
Mycoplasma Infection
Health
Concerta
PS
Stevens-Johnson Syndrome
Professional
Manufacturer
Route
Duration
ORAL
Date:11/18/03ISR Number: 4237722-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031100660
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
27 MG, 1 IN 1
DAY, ORAL
PT
Report Source
Product
Role
Body Height Below Normal
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
Date:11/19/03ISR Number: 4237465-4Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0379987A
Age:35 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Death
Hospitalization UNKNOWN
Initial or Prolonged
UNKNOWN
PT
Report Source
Product
Role
Manufacturer
Route
Acidosis
Cardiovascular Disorder
Consumer
Bupropion
Venlafaxine
PS
SS
Glaxosmithkline
ORAL
Completed Suicide
Methylphenidate
SS
Convulsion
Depressed Level Of
Consciousness
Hypotension
Hypothermia
Intentional Misuse
Respiratory Depression
Quetiapine
Clonazepam
Trazodone
Gabapentin
Lansoprazole
SS
SS
SS
SS
SS
Manufacturer
Route
Date:11/19/03ISR Number: 4238576-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031100960
Age:
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
36 MG, 1 IN 1
DAY
18-Aug-2005
Page: 422
11:49 AM
PT
Report Source
Product
Role
Hypotension
Syncope
Foreign
Health
Professional
Concerta Xl
(Methylphenidate
Hydrochloride)
Sustained
PS
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/19/03ISR Number: 4238945-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031002300
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Growth Retardation
Weight Gain Poor
White Blood Cell Count
Decreased
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:11/19/03ISR Number: 4239181-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031103067
Age:30 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Heart Rate Irregular
Medication Error
Overdose
Consumer
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
INJECTION
Date:11/20/03ISR Number: 4238136-0Report Type:Periodic
Age:15 YR
Gender:Male
I/FU:F
Outcome
Dose
PT
Company Report #US-GLAXOSMITHKLINE-A0430642A
Report Source
Product
Role
Manufacturer
Route
Joint Sprain
Wellbutrin
PS
Glaxosmithkline
ORAL
Sleep Walking
Concerta
SS
Duration
150MG Per day
2
MON
ORAL
54MG Per day
Date:11/21/03ISR Number: 4239170-7Report Type:Expedited (15-DaCompany Report #PHBS2003JP12770
Age:34 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
30 mg/day
PT
Report Source
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Duration
Drug Dependence
Date:11/21/03ISR Number: 4239370-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB04372
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
Anaemia
Contusion
10 mg, TID
Date:11/21/03ISR Number: 4239952-1Report Type:Direct
Age:27 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Suicidal Ideation
Company Report #CTU 206624
Report Source
Product
Role
Ritalin
PS
Date:11/21/03ISR Number: 4240503-6Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20031005088
Age:11 YR
Gender:Female
I/FU:F
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 423
11:49 AM
PT
Delusion
Diarrhoea
Disorientation
Feeling Abnormal
Gastroenteritis Viral
Hallucination
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Nausea
Vomiting
Dose
Report Source
Product
Role
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:11/24/03ISR Number: 4241392-6Report Type:Expedited (15-DaCompany Report #2003-03948
Age:38 YR
Gender:Unknown
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Death
Literature
Health
Professional
Methylphenidate
Hydrochloride
(Watson
Laboratories)(Methyl
phenidate
Verapamil (Watson
Laboratories)
(Verapamil
Hydrochloride)
Unknopwn
Trandolapril
(Trandolapril)
Role
Manufacturer
PS
Watson Laboratories
Route
Duration
SS
SS
Date:11/24/03ISR Number: 4241769-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031103820
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Brain Death
Cardiac Arrest
Cerebral Haemorrhage
Drug Abuser
Drug Ineffective
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Adderall (Obetrol)
SS
Manufacturer
Route
Duration
36 MG, 3 IN 1
Drug Interaction
DAY, ORAL
ORAL
Cocaine (Cocaine)
SS
Date:11/24/03ISR Number: 4242046-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031103246
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Leukopenia
Foreign
Health
Professional
Concerta Xl
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
54 MG, 1 IN 1
DAY, ORAL
Date:11/24/03ISR Number: 4242047-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031100962
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
Other
18-Aug-2005
Page: 424
11:49 AM
PT
Report Source
Product
Aggression
Intentional Self-Injury
Suicidal Ideation
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Role
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Sustained Release
Tablets
PS
ORAL
18 MG, 1 IN 1
DAY, ORAL
Date:11/25/03ISR Number: 4240737-0Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0383130A
Age:42 YR
Gender:Female
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Coma
Convulsion
Bupropion
Methylphenidate
PS
SS
Glaxosmithkline
ORAL
Depressed Level Of
Consciousness
Drug Ineffective
Intentional Misuse
Librax
Montelukast
Synthroid
C
C
C
Glaxosmithkline
Product
Role
Manufacturer
Route
Generic Ritalin 10
Mg
PS
Manufacturer
Route
Duration
UNKNOWN
Date:11/25/03ISR Number: 4242238-2Report Type:Direct
Age:60 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #CTU 206868
Report Source
Duration
Fatigue
Pharmaceutical Product
2 Q AM 1 Q
Complaint
NOON
30
DAY
Date:11/25/03ISR Number: 4242349-1Report Type:Expedited (15-DaCompany Report #HQWYE168918NOV03
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
1 TABLET
EVERY OTHER
PT
Report Source
Product
Role
Convulsion
Drug Interaction
Dyskinesia
Consumer
Dimetapp Nd
(Loratadine, Tablet,
Orally
Disintegrating)
PS
Duration
ORAL
DAY, ORAL
Concerta
(Methylphenidate, )
SS
ORAL
54 MG DAILY,
ORAL
Date:11/25/03ISR Number: 4242524-6Report Type:Expedited (15-DaCompany Report #03P-163-0241068-00
Age:38 YR
Gender:
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Completed Suicide
Literature
Health
Trandolapril/Verapam
il (Tarka Er)
PS
ORAL
Professional
Methylphenidate
SS
ORAL
Duration
ORAL
ORAL
Date:11/26/03ISR Number: 4242202-3Report Type:Direct
Age:60 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Manufacturer
Fatigue
Pharmaceutical Product
Generic Ritalin 10
Mg
PS
Geneva
Complaint
Methylphenidate 10
Mg
SS
Mallinckrodt
Duration
2Q AM 1Q NOON
18-Aug-2005
Page: 425
Company Report #CTU 206943
30
DAY
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:11/28/03ISR Number: 4243218-3Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #USP 56179
Report Source
Product
Role
Manufacturer
Methylphenidate
PS
Watson
Route
Duration
Medication Error
TABLET
Date:12/02/03ISR Number: 4246500-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030906118
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Alanine Aminotransferase
Increased
Aspartate
Aminotransferase
Increased
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
Blood Lactate
DAY, ORAL
Dehydrogenase Increased
Gamma-Glutamyltransferase
Increased
Liver Function Test
Abnormal
Date:12/03/03ISR Number: 4244708-XReport Type:Expedited (15-DaCompany Report #PHNR2003AU01641
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
40 mg mance
PT
Report Source
Product
Role
Manufacturer
Route
Ritalin La
PS
Novartis Sector:
Pharma
ORAL
Duration
Anorexia
Confusional State
2880 MIN
Crying
Discomfort
Dry Mouth
Fatigue
Headache
Heart Rate Increased
Muscle Twitching
Pain
Panic Attack
Tremor
Date:12/03/03ISR Number: 4245233-2Report Type:Expedited (15-DaCompany Report #PHBS2001JP08737
Age:19 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Blood Creatine
Phosphokinase Increased
Convulsion
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Psychotropic Agents
C
UNKNOWN
Depressed Level Of
Consciousness
Hyperthermia Malignant
Shock
Date:12/03/03ISR Number: 4246675-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031002540
Age:45 YR
Gender:Male
I/FU:F
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 426
11:49 AM
PT
Acute Myocardial
Infarction
Report Source
Health
Professional
Company
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Representative
Dose
Product
Role
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Vioxx (Rofecoxib)
C
Manufacturer
Route
Duration
ORAL
ORAL
Date:12/03/03ISR Number: 4246799-9Report Type:Expedited (15-DaCompany Report #CEL-2003-03659-ROC
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Eye Movement Disorder
Fear
Hallucination
Insomnia
Consumer
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
ORAL
Paxil (Paroxetine
Hydrochloride)
SS
ORAL
Duration
20 MG (20 MG,
Muscle Twitching
QAM), PO
Oral Intake Reduced
Psychotic Disorder
20 MG, (20
Schizophrenia
MG, Q HS), PO
Thinking Abnormal
Date:12/03/03ISR Number: 4246841-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030906118
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Alanine Aminotransferase
Increased
Aspartate
Aminotransferase
Increased
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablet
PS
Manufacturer
Route
Duration
36 MG, 1 IN 1
ORAL
Blood Lactate
DAY, ORAL
Dehydrogenase Increased
Gamma-Glutamyltransferase
Increased
Date:12/05/03ISR Number: 4251824-5Report Type:Expedited (15-DaCompany Report #CEL-2003-04227-ROC
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Psychotic Disorder
Health
Professional
Company
Representative
Metadate Cd Capsules
(Strength
Unspecified)
(Methylphenidate
PS
Manufacturer
Route
Manufacturer
Route
Duration
Date:12/08/03ISR Number: 4248762-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031105182
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG, 1 IN 1
DAY, ORAL
18-Aug-2005
Page: 427
PT
Report Source
Product
Role
Hypothyroidism
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/08/03ISR Number: 4248763-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030803159
Age:18 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abdominal Discomfort
Agitation
Disturbance In Attention
Miosis
Nausea
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Medikinet
(Methylphenidate
Hydrochloride)
C
Manufacturer
Route
ORAL
18 MG, 1 IN 1
Restlessness
DAY, ORAL
Tachycardia
Vertigo
Date:12/08/03ISR Number: 4248764-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031105179
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hypothyroidism
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
DAY, ORAL
Date:12/08/03ISR Number: 4248765-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031200008
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hyperthyroidism
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
18 MG, 1 IN 1
ORAL
DAY, ORAL
Date:12/08/03ISR Number: 4249345-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-200030705724
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Glossodynia
Local Swelling
Oedema Peripheral
Platelet Count Decreased
Pyrexia
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
54 MG, 1 IN 1
Rash Erythematous
DAY, ORAL
Swollen Tongue
18-Aug-2005
Page: 428
Manufacturer
Route
Duration
11:49 AM
Risperdal
(Risperidone)
Unspecified
Keflex (Cefalexin
Monohydrate)
Prozac (Fluoxetine
Hydrochloride)
SS
C
C
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/09/03ISR Number: 4248604-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE04286
Age:19 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
40mg/day
Other
PT
Report Source
Drug Dependence
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Sinquan
/Den/
C
ORAL
Date:12/11/03ISR Number: 4250967-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20031103067
Age:30 YR
Gender:Female
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Depressed Level Of
Consciousness
Glomerulosclerosis
Heart Rate Irregular
Consumer
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Manufacturer
Route
Duration
INJECTION
Overdose
Self-Medication
Date:12/12/03ISR Number: 4250320-9Report Type:Expedited (15-DaCompany Report #PHBS2001JP08737
Age:19 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Manufacturer
Route
Blood Creatine
Phosphokinase Increased
Convulsion
Health
Professional
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Psychotropic Agents
C
UNKNOWN
Depressed Level Of
Consciousness
Enteritis
Extrapyramidal Disorder
Gastrointestinal Necrosis
Hyperthermia Malignant
Multi-Organ Failure
Nasopharyngitis
Neuroleptic Malignant
Syndrome
Rhabdomyolysis
Self-Medication
Shock
Tremor
Date:12/12/03ISR Number: 4250324-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE04299
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Ventricular Extrasystoles
30mg/day
Bisoprolol
C
ORAL
Date:12/15/03ISR Number: 4251323-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE04318
Age:16 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Joint Effusion
Juvenile Arthritis
35 mg/day
18-Aug-2005
Page: 429
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/16/03ISR Number: 4252008-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE04298
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
10mg/day
Other
PT
Product
Role
Manufacturer
Route
Coma
Difficulty In Walking
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Drug Level Increased
Electroencephalogram
Abnormal
Tic
Ritaline
Date:12/17/03ISR Number: 4253201-XReport Type:Direct
Age:49 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
SS
Novartis Sector:
Pharma
Product
Role
Manufacturer
Route
Generic Ritalin
PS
Route
Company Report #CTU 208200
Report Source
Duration
Asthenia
Headache
Nausea
Pharmaceutical Product
Complaint
Vision Blurred
Vomiting
Date:12/17/03ISR Number: 4253334-8Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Report Source
PT
Company Report #CTU 208195
Report Source
Product
Role
Manufacturer
Methylphenidate 20
Mg (Celltech Brand)
PS
Celltech
Duration
Pharmaceutical Product
Complaint
20 MG THREE
Psychomotor Hyperactivity
TIMES DAY BY
MOUTH
Date:12/17/03ISR Number: 4254297-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031201156
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
18 MG, 1 IN 1
PT
Report Source
Product
Role
Delusion
Foreign
Concerta Xl
PS
Hallucination, Auditory
Health
Hallucination, Visual
Psychotic Disorder
Thinking Abnormal
Professional
Manufacturer
Route
Manufacturer
Route
DAY
Date:12/17/03ISR Number: 4254300-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031201154
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
18-Aug-2005
Page: 430
11:49 AM
PT
Report Source
Product
Role
Grand Mal Convulsion
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/17/03ISR Number: 4254304-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031200590
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Confusional State
Epilepsy
Eye Pain
Restlessness
Retrograde Amnesia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
ORAL
36 MG, 1 IN 1
Sleep Walking
DAY, ORAL
Tremor
Date:12/17/03ISR Number: 4267017-1Report Type:Periodic
Age:44 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
Company Report #2013191
PT
Report Source
Product
Overdose
Health
Professional
Oxycodone
Hydrochloride
(Similar To Nda
20-553) (Oxycodone
Hydrochloride
Ethyl Alcohol
(Ethanol)
Alfenta (Alfentanil
Hydrochloride)
Sublimaze (Fentanyl)
Sufenta (Sufentanil
Citrate)
Ritalin
(Methylphenidate
Hydrochloride)
Percodan
(Acetylsalicylic
Acid, Oxycodone
Hydrochl)
Role
Duration
PS
SS
SS
SS
SS
SS
SS
Date:12/18/03ISR Number: 4255942-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031105182
Age:14 YR
Gender:Male
I/FU:F
Manufacturer
Route
Outcome
Dose
Other
PT
Report Source
Product
Role
Hypothyroidism
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Equasym
(Methylphenidate
Hydrochloride)
C
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
DAY, ORAL
Date:12/18/03ISR Number: 4255950-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031105179
Age:
Gender:Female
I/FU:F
Outcome
Dose
Other
36 MG, 1 IN 1
18-Aug-2005
Page: 431
PT
Report Source
Product
Role
Hypothyroidism
Thyroiditis
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
DAY, ORAL
Date:12/18/03ISR Number: 4273919-2Report Type:Periodic
Age:31 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
Company Report #HQ9570718DEC2001
PT
Report Source
Product
Role
Abortion Spontaneous
Drug Withdrawal Syndrome
Infertility Female
Nausea
Pregnancy
Health
Professional
Effexor Xr
(Venlafaxine
Hydrochloride,
Capsule, Extended
Release)
PS
Manufacturer
Route
Duration
ORAL
SEE IMAGE
ORAL
Ritalin
(Methylphenidate
Hydrochloride, )
Wellbutrin
(Amfebutamone
Hydrochloride)
Methylphenidate
(Methylphenidate)
SS
C
C
Date:12/19/03ISR Number: 4254769-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB04698
Age:
Gender:
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Pharma
Product
Role
Manufacturer
Ritalin
PS
Novartis Sector:
Pharma
Route
Duration
Paraplegia
5 mg, BID
Date:12/19/03ISR Number: 4254792-5Report Type:Expedited (15-DaCompany Report #PHBS2003JP13732
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Duration
TRANSPLACENTAL
Drug Exposure During
Pregnancy
Route
Drug Toxicity
Paxil
C
Flunitrazepam
C
TRANSPLACENTAL
TRANSPLACENTAL
Date:12/19/03ISR Number: 4254816-5Report Type:Expedited (15-DaCompany Report #PHNR2003AU01542
Age:
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Route
Duration
Abdominal Pain Upper
Chest Pain
10 mg morning
Diarrhoea
and 10 mg
Nausea
noon
Pharmaceutical Product
Complaint
Ritalin
SS
unspecified
Date:12/19/03ISR Number: 4254824-4Report Type:Expedited (15-DaCompany Report #PHBS2003JP13893
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Drug Abuser
UNKNOWN
18-Aug-2005
Page: 432
Report Source
Product
Role
Manufacturer
Ritalin
PS
Novartis Sector:
Pharma
Duration
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/19/03ISR Number: 4256482-1Report Type:Expedited (15-DaCompany Report #DK-JNJFOC-20031201656
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Chest Wall Pain
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Manufacturer
Route
18 MG, 1 IN 1
DAY ; 36 MG
Date:12/19/03ISR Number: 4256552-8Report Type:Expedited (15-DaCompany Report #SUSI-2003-00501
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Brain Death
Cardiac Arrest
Cerebral Haemorrhage
Drug Ineffective
Other
Adderall
(Amphetamine
Aspartate,
Amphetamine Sulfate,
Dextroamphetamine
Concerta
(Methylphenidate
Hydrochloride)
Role
Duration
PS
SS
ORAL
36 MG 3 IN 1
DAY, ORAL
Cocaine (Cocaine)
SS
Date:12/19/03ISR Number: 4256580-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030803159
Age:18 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
18 MG, 1 IN 1
PT
Report Source
Product
Role
Abdominal Discomfort
Agitation
Disturbance In Attention
Miosis
Nausea
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
ORAL
Paraesthesia
DAY, ORAL
Restlessness
Tachycardia
Vertigo
Medikinet (Tablets)
Methylphenidate
Hydrochloride
C
Date:12/22/03ISR Number: 4256155-5Report Type:Expedited (15-DaCompany Report #PHBS2003JP13732
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Cyanosis Neonatal
Drug Exposure During
Health
Professional
Ritalin
PS
Novartis Sector:
Pharma
Pregnancy
Solanax
SS
Drug Toxicity
Paxil
C
Maternal Drugs Affecting
Flunitrazepam
C
Route
Duration
TRANSPLACENTAL
TRANSPLACENTAL
TRANSPLACENTAL
TRANSPLACENTAL
Foetus
Date:12/23/03ISR Number: 4256921-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE04364
Age:6 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
15 mg/day
PT
Henoch-Schonlein Purpura
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Ritaline
18-Aug-2005
Page: 433
11:49 AM
SS
Novartis Sector:
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Pharma
ORAL
Route
15 mg/day
Date:12/23/03ISR Number: 4256922-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB04787
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Pharma
Duration
Mania
Date:12/23/03ISR Number: 4258081-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031202846
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Confusional State
Disorientation
Nervousness
Pain In Extremity
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained
PS
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
Tremor
DAY, ORAL
Visual Brightness
Date:12/23/03ISR Number: 4258208-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031203572
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
RECEIVED OROS
METHYLPHENIDA
TE
HYDROCHLORIDE
PT
Report Source
Product
Role
Sudden Cardiac Death
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
FOR EXTENDED
Date:12/23/03ISR Number: 4258417-4Report Type:Direct
Age:26 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 208657
Report Source
Product
Role
Methylphenidate
PS
Manufacturer
Route
Manufacturer
Route
Duration
Agitation
Date:12/23/03ISR Number: 4258940-2Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20031000841
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Cold Sweat
Crying
Dyspnoea
Ear Discomfort
Hyperhidrosis
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Luvox (Fluvoxamine
Maleate)
C
1 IN 1 DAY,
Oral Intake Reduced
ORAL
Pallor
Palpitations
Panic Attack
Salivary Hypersecretion
18-Aug-2005
Page: 434
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/24/03ISR Number: 4257435-XReport Type:Expedited (15-DaCompany Report #PHBS2003NL14116
Age:24 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Citalopram
C
Duration
Abnormal Behaviour
Alcohol Use
Dyspnoea
UNKNOWN
Date:12/24/03ISR Number: 4257507-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB03027
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Sinus Tachycardia
Ventricular Hypertrophy
Health
Professional
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Route
Duration
15 mg, BID
Date:12/24/03ISR Number: 4257728-6Report Type:Expedited (15-DaCompany Report #PHBS2003JP13732
Age:
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Manufacturer
Apnoea
Cyanosis Neonatal
Ritalin
PS
Novartis Sector:
Pharma
Drug Exposure During
Paxil
SS
Pregnancy
Rohypnol
SS
Drug Toxicity
Solanax
SS
TRANSPLACENTAL
TRANSPLACENTAL
TRANSPLACENTAL
TRANSPLACENTAL
Hypotonia Neonatal
Irritability
Neonatal Disorder
Tremor
Date:12/26/03ISR Number: 4258306-5Report Type:Expedited (15-DaCompany Report #PHNU2003DE04318
Age:15 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Arthralgia
Blood Immunoglobulin G
Health
Professional
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
35 mg/day
Increased
Blood Immunoglobulin M
Ritaline
SS
35 mg/day
Increased
Erythema Infectiosum
Joint Effusion
Joint Warmth
Juvenile Arthritis
Date:12/26/03ISR Number: 4260481-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031204142
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Blood Creatine
Phosphokinase Increased
Blood Uric Acid Increased
Muscle Enzyme Increased
Renal Failure
Health
Professional
Concerta
(Methyylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Docycyline
(Doxycycline)
C
ORAL
Vomiting
18-Aug-2005
Page: 435
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:12/26/03ISR Number: 4260485-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031103427
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abnormal Behaviour
Aggression
Antisocial Behaviour
Pyromania
Refusal Of Treatment By
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
ORAL
Relative
Date:12/26/03ISR Number: 4260493-XReport Type:Expedited (15-DaCompany Report #CEL-2003-04228-SLO
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Alanine Aminotransferase
Increased
Aspartate
Foreign
Health
Professional
Equasym 20mg
(Methylphenidate
Hydrochloride)
PS
Aminotransferase
Other
Manufacturer
Route
ORAL
20 MG (20 MG,
DAILY), PO
Increased
Blood Creatine
Phosphokinase Increased
Blood Lactate
Dehydrogenase Increased
Viral Myositis
Date:12/30/03ISR Number: 4260450-3Report Type:Expedited (15-DaCompany Report #PHBS2003CA11766
Age:69 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Abnormal Behaviour
Aggression
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Disinhibition
High Risk Sexual
Ritalin
Novartis Sector:
Pharma
ORAL
Behaviour
Ritalin
Duration
2.5 mg, BID
SS
5 mg, BID
SS
Novartis Sector:
Perseveration
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
12.5 mg/day
Sexual Activity Increased
Ritalin
SS
5 mg, BID
Ritalin
SS
7.5 mg, BID
UNKNOWN
Phenytoin
C
Salbutamol
Asa
C
C
Allopurinol
C
Lactulose
C
Domperidone
C
Pulmicort
Tylenol
C
C
Colace
C
Losec
C
Warfarin
C
Dilantin
C
Symbicort
C
Acetaminophen
C
Diazepam
C
Mom
C
Dulcolax
C
Selsun
C
Aveeno Oil
C
225 mg, QHS
UNKNOWN
80 mg/day
UNKNOWN
20 mg/day
UNKNOWN
UNKNOWN
20 mg, Q6H
UNKNOWN
UNK, UNK
UNKNOWN
UNKNOWN
UNKNOWN
UNKNOWN
UNKNOWN
UNKNOWN
PRN
INTRAMUSCULAR
PRN
UNKNOWN
PRN
UNKNOWN
PRN
PRN
UNKNOWN
18-Aug-2005
Page: 436
PRN
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/02/04ISR Number: 4264591-6Report Type:Expedited (15-DaCompany Report #CEL-2003-03447-ROC
Age:
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Stevens-Johnson Syndrome
Health
Professional
Methylphenidate Slow Release
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Date:01/02/04ISR Number: 4264642-9Report Type:Expedited (15-DaCompany Report #2003189650JP
Age:1 DY
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Apgar Score Abnormal
Cyanosis Central
Foreign
Health
Solanax (Alprazolam)
Tablet
PS
ORAL
Drug Exposure During
Professional
Pregnancy
Drug Withdrawal Syndrome
Other
Paxil (Paroxetine
Hydrochloride)
SS
ORAL
Rohypnol
(Flunitrazepam)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
0.8 MG/DAY,
ORAL
30 MG/DAY,
Neonatal
ORAL
Hypersensitivity
Hypopnoea
2 MG/DAY,
Hypotonia
ORAL
Irritability
Muscle Twitching
Neonatal Apnoeic Attack
100 MG/DAY,
Therapeutic Agent
ORAL
Toxicity
Date:01/04/04ISR Number: 4263190-XReport Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Duration
Company Report #CTU 209285
Report Source
Product
Role
Manufacturer
Route
Drug Effect Decreased
Ritalin
PS
20 MG TID
Pharmaceutical Product
Complaint
Date:01/06/04ISR Number: 4263860-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE04299
Age:
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Ventricular Extrasystoles
10 mg, TID
Bisoprolol
C
ORAL
10 mg, QD
Date:01/06/04ISR Number: 4265397-4Report Type:Direct
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization GIVEN 2 ONLY
Initial or Prolonged
18-Aug-2005
Page: 437
11:49 AM
PT
Abnormal Behaviour
Blood Pressure Increased
Crying
Difficulty In Walking
Hyperventilation
Medication Error
Posturing
Company Report #CTU 209435
Report Source
Product
Role
Concerta 54 Mg
PS
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/06/04ISR Number: 4266079-5Report Type:Expedited (15-DaCompany Report #TW-JNJFOC-20031204885
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Depressed Level Of
Consciousness
Medication Error
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
ORAL
18 MG, 1 IN 1
DAY, ORAL
Date:01/07/04ISR Number: 4267018-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031203572
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Sudden Cardiac Death
Ventricular Extrasystoles
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
ORAL
SEE IMAGE
Coumadin (Warfarin
Sodium)
Lanoxin (Digoxin)
Lasix (Furosemide)
Prozac (Fluoxetine
Hydrochloride)
Zyrtec (Cetirizine
Hydrochloride)
Capoten (Captopril)
Cordarone
(Amiodarone
Hydrochloride)
C
C
C
C
C
C
C
Date:01/08/04ISR Number: 4267082-1Report Type:Expedited (15-DaCompany Report #PHBS2003JP13732
Age:
Gender:Male
I/FU:F
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Life-Threatening
Apgar Score Low
Cyanosis Central
Health
Professional
Ritalin
PS
Drug Abuser
Paxil
SS
Drug Exposure During
Rohypnol
SS
Pregnancy
Solanax
SS
TRANSPLACENTAL
TRANSPLACENTAL
TRANSPLACENTAL
TRANSPLACENTAL
Drug Toxicity
Drug Withdrawal Syndrome
Neonatal
Hypotonia Neonatal
Irritability
Meconium Stain
Neonatal Apnoeic Attack
Neonatal Disorder
Tremor Neonatal
Date:01/08/04ISR Number: 4268596-0Report Type:Expedited (15-DaCompany Report #IL-JNJFOC-20040100024
Age:11 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 438
PT
Chest Pain
Electrocardiogram Qt
Prolonged
11:49 AM
Novartis Sector:
Pharma
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Tachycardia
Dose
Report Source
Product
Role
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
36 MG, ORAL
Date:01/08/04ISR Number: 4268603-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031002658
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Asthenia
Blood Lactate
Dehydrogenase Increased
Gamma-Glutamyltransferase
Increased
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
Liver Function Test
DAY, ORAL
Abnormal
Date:01/09/04ISR Number: 4267535-6Report Type:Periodic
Age:33 YR
Gender:Male
I/FU:F
Outcome
Dose
PT
Company Report #US-GLAXOSMITHKLINE-A0422163A
Report Source
Product
Role
Manufacturer
Route
Wellbutrin
PS
Glaxosmithkline
ORAL
Concerta
SS
Duration
Drug Interaction
150MG Twice
Drug Screen False
per day
Positive
54MG Per day
Date:01/09/04ISR Number: 4267638-6Report Type:Periodic
Age:
Gender:Male
I/FU:I
Company Report #US-GLAXOSMITHKLINE-A0433001A
ORAL
Outcome
Dose
PT
Report Source
Product
Role
Manufacturer
Route
Wellbutrin
PS
Glaxosmithkline
ORAL
Concerta
SS
Duration
Heart Rate Increased
150MG Unknown
ORAL
18MG Per day
Date:01/09/04ISR Number: 4269136-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031105477
Age:15 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Abortion Spontaneous
Complications Of Maternal
Exposure To Therapeutic
Drugs
Foreign
Health
Professional
Concerta Xr Concerta
Xr (Methylphenidate
Hydrochloride)Sustai
ned Release Tablets
PS
Manufacturer
Route
Duration
ORAL
54 MG, IN 1
Drug Exposure During
DAY, ORAL
Pregnancy
Unintended Pregnancy
Date:01/12/04ISR Number: 4269346-4Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Ritalin
PS
Duration
Drug Ineffective
20 MG TID
Pharmaceutical Product
Complaint
18-Aug-2005
Page: 439
Company Report #CTU 209767
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/13/04ISR Number: 4270799-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031002164
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Abnormal Behaviour
Obsessive-Compulsive
Disorder
Study
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
DAY, ORAL
Date:01/13/04ISR Number: 4271521-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031002658
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Alanine Aminotransferase
Increased
Aspartate
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
Aminotransferase
DAY, ORAL
Increased
Asthenia
Blood Lactate
Dehydrogenase Increased
Gamma-Glutamyltransferase
Increased
Date:01/14/04ISR Number: 4270535-3Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0319266A
Age:42 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Zyban
Ritalin
PS
SS
Glaxosmithkline
Duration
Drug Abuser
Route
Date:01/15/04ISR Number: 4274303-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040101263
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
Other
PT
Report Source
Product
Role
Headache
Leukopenia
Neutropenia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
18 MG, ORAL
Date:01/16/04ISR Number: 4273163-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE03876
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Anorexia
Nausea
Health
Professional
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Unknown
Decortin
C
ORAL
Methotrexat
C
ORAL
2.5 mg/day
Unknown
Date:01/16/04ISR Number: 4276414-XReport Type:Expedited (15-DaCompany Report #DK-JNJFOC-20031201656
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 440
11:49 AM
PT
Report Source
Product
Chest Pain
Dyslexia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Role
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Sustained Release
Tablets
PS
18 MG, 1 IN 1
DAY; SEE
IMAGE
Date:01/20/04ISR Number: 4274637-7Report Type:Expedited (15-DaCompany Report #PHBS2004SE00847
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Abdominal Pain Upper
Aggression
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Decreased Appetite
Depression
Ritalin
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Manufacturer
Route
Duration
0.5 mg/day
SS
60 mg/day
Dry Mouth
Hallucination
Palpitations
Psychomotor Hyperactivity
Sleep Disorder
Suicidal Ideation
Date:01/20/04ISR Number: 4276318-2Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 210483
Report Source
Product
Role
Methylphenidate
10mg
PS
Duration
Educational Problem
Pharmaceutical Product
1 1/2 TABS
Complaint
TID
Date:01/21/04ISR Number: 4275165-5Report Type:Expedited (15-DaCompany Report #PHBS2003JP13732
Age:
Gender:Male
I/FU:F
Outcome
Dose
PT
Duration
Report Source
Product
Role
Life-Threatening
Hospitalization TRANSPLACENTAL
Initial or Prolonged
TRANSPLACENTAL
Apgar Score Low
Cyanosis Neonatal
Health
Professional
Ritalin
PS
Drug Abuser
Paxil
SS
Drug Exposure During
Rohypnol
SS
Pregnancy
Solanax
SS
Novartis Sector:
Pharma
TRANSPLACENTAL
TRANSPLACENTAL
Drug Toxicity
Drug Withdrawal Syndrome
Neonatal
Hypotonia Neonatal
Irritability
Meconium Stain
Neonatal Apnoeic Attack
Neonatal Disorder
Tremor Neonatal
Date:01/23/04ISR Number: 4316812-9Report Type:Direct
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #USP 56369
Report Source
Product
Role
Manufacturer
Methylin 5 Mg
PS
Mallincrodt
Methadone 5 Mg
SS
Roxane
Duration
Medication Error
TABLET
TABLET
18-Aug-2005
Page: 441
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/26/04ISR Number: 4279919-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040101913
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Alopecia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Ritalin
(Methylphenidate
Hydrochloride)
Unknown
C
Manufacturer
Route
Duration
ORAL
36 MG, ORAL
Date:01/26/04ISR Number: 4280106-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040101912
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Haemoglobin Decreased
Leukopenia
Red Blood Cell Count
Decreased
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Manufacturer
Route
Duration
ORAL
36 MG, ORAL
White Blood Cell Count
Decreased
Date:01/26/04ISR Number: 4280109-6Report Type:Expedited (15-DaCompany Report #TW-JNJFOC-20031204885
Age:7 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
18 MG, 1 IN 1
DAY, ORAL
PT
Report Source
Product
Role
Depressed Level Of
Consciousness
Heart Rate Increased
Hypokinesia
Medication Error
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
ORAL
Date:01/26/04ISR Number: 4280110-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031002658
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Alanine Aminotransferase
Increased
Aspartate
Aminotransferase
Increased
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
36 MG, 1 IN 1
Asthenia
DAY, ORAL
Blood Lactate
Dehydrogenase Increased
Gamma-Glutamyltransferase
Increased
Date:01/27/04ISR Number: 4280381-2Report Type:Expedited (15-DaCompany Report #MK200401-0144-1
Age:48 YR
Gender:Female
I/FU:I
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 442
Manufacturer
Route
Duration
11:49 AM
PT
Back Pain
Confusional State
Convulsion
Disorientation
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Insomnia
Medication Error
Muscle Spasms
Report Source
Product
Role
Nausea
Serotonin Syndrome
Literature
Health
Methylphenidate Hcl
Tabs, Usp 10mg
PS
Somnolence
Professional
Venlafaxine
SS
Zolpidem
SS
Manufacturer
Route
Manufacturer
Route
Duration
10 MG, TID
600 MG/DAY
FOR THREE
WEEKS PRIOR
TO EVENT
10 MG/DAY FOR
FOUR WEEKS
PRIOR TO
EVENT
Date:01/27/04ISR Number: 4280661-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031201154
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Fall
Grand Mal Convulsion
Muscle Rigidity
Petit Mal Epilepsy
Photosensitivity Reaction
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Relese
Tablets
PS
ORAL
36 MG, 1 IN 1
DAY, ORAL
Date:01/30/04ISR Number: 4284049-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040104848
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Other
Tachycardia
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Zoloft (Sertraline
Hydrochloride)
SS
ORAL
54 MG, 1 IN 1
DAY, ORAL
25 MG
Date:01/30/04ISR Number: 4284453-8Report Type:Direct
Age:
Gender:
I/FU:I
Outcome
Dose
PT
Company Report #USP 56289
Report Source
Product
Role
Manufacturer
Oxycontin
PS
Mallinckrodt
Methylin
SS
Mallinckrodt
Route
Duration
Medication Error
TABLET
TABLET
Date:01/30/04ISR Number: 4284709-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040103489
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
18 MG, ORAL
18-Aug-2005
Page: 443
PT
Report Source
Product
Role
Blindness
Coloboma
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/30/04ISR Number: 4288742-2Report Type:Periodic
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Mania
Consumer
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
Date:01/30/04ISR Number: 4288748-3Report Type:Periodic
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
Company Report #PHEH2003US01093
PT
Report Source
Product
Role
Dependence
Psychotic Disorder
Other
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
PS
Date:01/30/04ISR Number: 4288752-5Report Type:Periodic
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #PHEH2003US00900
Company Report #PHEH2003US01390
PT
Report Source
Product
Role
Chest Pain
Health
Professional
Company
Representative
Ritalin
La(Methylphenidate
Hydrochloride)
Extended Release
Capsules
PS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
Tablet
SS
ORAL
Duration
40 MG, QD,
ORAL
10 MG, Q4PM,
ORAL
Date:01/30/04ISR Number: 4288753-7Report Type:Periodic
Age:32 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
Company Report #PHEH2003US02537
PT
Report Source
Product
Role
Convulsion
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride), 5 Mg
PS
Methadone
Hydrochloride
(Methadone
Hydrochloride) 10 Mg
SS
Msir (Morphine
Sulfate) 15 Mg
SS
Actiq(Fentanyl
Citrate)
SS
Provigil (Modafinil)
SS
Efexor (Venlafaxine
Hydrochloride)
SS
Manufacturer
Route
Duration
25 MG, TID
100 MG, TID
60 MG, Q3-4HR
PRN
PRN, ORAL
300MG/DAY
225 MG, QHS
18-Aug-2005
Page: 444
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:01/30/04ISR Number: 4288767-7Report Type:Periodic
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #PHEH2003US02805
PT
Report Source
Product
Role
Mental Disorder
Consumer
Ritalin
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
Date:01/30/04ISR Number: 4288789-6Report Type:Periodic
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abnormal Behaviour
Consumer
Ritalin
(Methylphenidate
Hydrochloride)
PS
Date:01/30/04ISR Number: 4288792-6Report Type:Periodic
Age:39 YR
Gender:
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Company Report #PHEH2003US04566
Company Report #PHEH2003US04816
PT
Report Source
Product
Role
Abnormal Behaviour
Overdose
Health
Professional
Ritalin
(Methylphenidate
Hydrochloride)
PS
Methylphenidate
Hydrochloride
(Methylphenidate)
SS
Ddvat
C
5 MG
5 MG
Date:01/30/04ISR Number: 4288794-XReport Type:Periodic
Age:34 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #PHEH2003US04828
PT
Report Source
Product
Role
Arrhythmia
Condition Aggravated
Health
Professional
Ritalin(Methylphenid
ate Hydrochloride)
PS
Duration
Date:01/30/04ISR Number: 4288796-3Report Type:Periodic
Age:2 YR
Gender:
I/FU:I
Outcome
Dose
Other
Company Report #PHEH2003US05205
PT
Report Source
Product
Role
Accidental Exposure
Dyskinesia
Heart Rate Abnormal
Health
Professional
Ritalin La
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
40 MG,
Insomnia
ONCE/SINGLE,
Logorrhoea
ORAL
Psychomotor Hyperactivity
Vomiting
Date:02/02/04ISR Number: 4283366-5Report Type:Expedited (15-DaCompany Report #PHNU2004DE00618
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Blood Creatinine
Increased
Health
Professional
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
10 mg, BID
Glomerulonephritis
Proteinuria
18-Aug-2005
Page: 445
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/02/04ISR Number: 4284784-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031201156
Age:
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Delusion
Hallucinations, Mixed
Psychotic Disorder
Thinking Abnormal
Foreign
Health
Professional
Concerta Xl
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
18 MG, 1 IN 1
DAY
Date:02/02/04ISR Number: 4285493-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040103955
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Intracranial Aneurysm
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Duration
Date:02/02/04ISR Number: 4285495-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031100960
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Condition Aggravated
Loss Of Consciousness
Orthostatic Hypotension
Syncope
Foreign
Health
Professional
Concerta Xl
(Methylphenidate
Hydrochloride
)Sustained Release
Tablets
PS
SEE IMAGE
Becotide
(Beclometasone
Dipropionate)Inhalat
ion
Ventolin
(Salbutamol)
Inhalation
C
C
Date:02/03/04ISR Number: 4284419-8Report Type:Expedited (15-DaCompany Report #PHBS2004JP00800
Age:48 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
80 mg/day
PT
Report Source
Product
Role
Manufacturer
Route
Depression
Palpitations
Health
Professional
Diovan
PS
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Duration
99360MIN
Psychotic Disorder
Tachycardia
160 mg/day
Diovan
7200 MIN
Diovan
40 mg/day
SS
SS
10080MIN
Ritalin
Amoxan
Serenal
Rohypnol
Lofepramine
Hydrochloride
Toledomin
Diovan
SS
SS
SS
SS
ORAL
ORAL
ORAL
ORAL
SS
SS
SS
ORAL
ORAL
Novartis Sector:
Pharma
ORAL
80 mg/day
40 mg/day
Adalat
C
ORAL
Bayaspirin
C
ORAL
Herbesser "Tanabe"
C
ORAL
8640 MIN
100 mg, UNK
200 mg, UNK
18-Aug-2005
Page: 446
10080MIN
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Nitroderm Tts
TRANSDERMAL
Date:02/03/04ISR Number: 4601314-2Report Type:Periodic
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
C
50 mg/dat
Company Report #PHEH2004US12534
PT
Report Source
Product
Role
Aggression
Eye Rolling
Headache
Consumer
Ritalin(Methylphenid
ate Hydrochloride)
Tablet
PS
Manufacturer
Route
Manufacturer
Route
Duration
5 MG, BID
Psychomotor Hyperactivity
Psychotic Disorder
Date:02/03/04ISR Number: 4601316-6Report Type:Periodic
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #PHEH2004US12841
PT
Report Source
Product
Role
Drug Withdrawal Syndrome
Sleep Disorder
Consumer
Ritalin
La(Methylphenidate
Hydrochloride)
Extended Release
Capsules
PS
Unspecified
Medication For
Adhd()
SS
Duration
ORAL
50 MG, QD,
ORAL
Date:02/04/04ISR Number: 4284872-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB00789
Age:18 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Aggression
Drug Dependence
20 mg, BID
Psychiatric Symptom
Schizophrenia
Date:02/04/04ISR Number: 4284879-2Report Type:Expedited (15-DaCompany Report #PHBS2003ZA09019
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Arrhythmia
Brain Oedema
Health
Professional
Ritalin La
PS
Novartis Sector:
Pharma
ORAL
Duration
20 mg/day
Circulatory Collapse
UNKNOWN
Budesonide
C
Flixonase
Inflammide
C
C
Ventolin
C
50
Rhinitis Allergic
microgram/d
Sudden Death
Wheezing
200 ug, BID
UNKNOWN
one or twice
every three
months
Date:02/04/04ISR Number: 4285301-2Report Type:Expedited (15-DaCompany Report #PHBS2004JP01478
Age:
Gender:Male
I/FU:I
Outcome
Death
Other
18-Aug-2005
Page: 447
PT
Completed Suicide
Depression
Drug Abuser
11:49 AM
NASAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Insomnia
Intentional Misuse
Overdose
Dose
Report Source
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Lexotan
Wypax
Flumezin
Akineton
Brovarin
Isomytal
C
C
C
C
C
C
Manufacturer
Route
Duration
Suicide Attempt
Date:02/05/04ISR Number: 4287303-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040200246
Age:7 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Glaucoma
Optic Nerve Cupping
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
ORAL
18 MG, 1 IN 1
DAY, ORAL
Date:02/05/04ISR Number: 4288543-5Report Type:Expedited (15-DaCompany Report #2003189650JP
Age:1 DY
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
PT
Report Source
Product
Role
Manufacturer
Route
Apgar Score Low
Cyanosis Central
Foreign
Health
Solanax (Alprazolam)
Tablet
PS
ORAL
Drug Toxicity
Professional
Drug Withdrawal Syndrome
Heart Rate Increased
Other
Paxil (Paroxetine
Hydrochloride)
SS
ORAL
0.8 MG/DAY,
ORAL
30 MG/DAY,
Hypersensitivity
ORAL
Hypopnoea
Rohypnol
Hypotonia
(Flunitrazepam)
SS
ORAL
Ritalin
(Methylphenidate
Hydrochloride)
SS
ORAL
2 MG/DAY,
Hypotonia Neonatal
ORAL
Irritability
Maternal Drugs Affecting
Foetus
100 MG/DAY,
Muscle Twitching
ORAL
Neonatal Apnoeic Attack
Date:02/06/04ISR Number: 4289271-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040103955
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Intracranial Aneurysm
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Duration
Date:02/06/04ISR Number: 4290062-7Report Type:Direct
Age:12 YR
Gender:Female
I/FU:I
Outcome
Life-Threatening
Required
18-Aug-2005
Page: 448
11:49 AM
Company Report #CTU 211694
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Intervention to
Prevent Permanent
Impairment/Damage
PT
Dose
Report Source
Product
Role
Manufacturer
Route
Concerta 27 Mg Alza
PS
Alza
ORAL
Product
Role
Manufacturer
Route
Aggression
Drug Dependence
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Persecutory Delusion
Ritalin
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Duration
Depression
27 MG ONE
Suicidal Ideation
DAILY ORAL
Date:02/09/04ISR Number: 4289948-9Report Type:Expedited (15-DaCompany Report #PHBS2004JP01531
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
10 mg/day
PT
Report Source
SS
80 mg/day
Ritalin
300 mg
SS
1440 MIN
Tofranil
Lexotan
C
C
Depas
C
ORAL
UNKNOWN
UNKNOWN
Date:02/09/04ISR Number: 4290182-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031103481
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
SEE IMAGE
PT
Report Source
Product
Role
Disorientation
Grand Mal Convulsion
Incontinence
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
ORAL
Date:02/09/04ISR Number: 4290188-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031003780
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Anxiety
Pica
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablet
PS
SEE IMAGE
Albuterol
(Salbutamol)
Singulair (Tablets)
Montelukast Sodium
Tablets
C
C
Date:02/09/04ISR Number: 4290900-8Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040106204
Age:9 YR
Gender:Female
I/FU:I
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 449
Manufacturer
Route
Duration
11:49 AM
PT
Abdominal Pain
Dehydration
Enterococcal Infection
Hypertension
Insomnia
Nausea
Psychomotor Hyperactivity
Urinary Tract Infection
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Vomiting
Dose
Report Source
Product
Role
Foreign
Study
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Clonidine
(Clonidine)
C
Manufacturer
Route
Duration
ORAL
54 MG, 1 IN 1
DAY, ORAL
Date:02/10/04ISR Number: 4290240-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE03032
Age:
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Unknown
Other
18mg/day
PT
Report Source
Product
Role
Manufacturer
Route
Aggression
Anger
Consumer
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Anxiety
Concerta
C
ORAL
Blister
Truxal
C
ORAL
Cardiovascular Disorder
Atosil
C
ORAL
Chest Pain
Tegretal
C
75 mg/day
75 mg/day
1600 mg/day
Depression
Drug Dependence
Drug Toxicity
Drug Withdrawal Syndrome
Erectile Dysfunction
Fatigue
Feeling Abnormal
Heart Rate Increased
Libido Increased
Nervousness
Nightmare
Rash
Renal Pain
Restlessness
Sleep Disorder
Suicide Attempt
Date:02/10/04ISR Number: 4293368-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040200827
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Anxiety
Crying
Depressed Mood
Fear
Insomnia
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
18 MG, 1 IN 1
Nervousness
DAY, ORAL
Speech Disorder
Suicidal Ideation
Date:02/11/04ISR Number: 4291423-2Report Type:Expedited (15-DaCompany Report #PHBS2004JP00800
Age:48 YR
Gender:Male
I/FU:F
Outcome
Other
18-Aug-2005
Page: 450
Manufacturer
Route
Duration
PT
Depression
Palpitations
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Psychotic Disorder
Tachycardia
Report Source
Dose
Product
Role
Manufacturer
Route
Diovan
PS
ORAL
Diovan
SS
ORAL
Diovan
SS
ORAL
Ritalin
SS
ORAL
Amoxan
SS
ORAL
Serenal
SS
ORAL
Rohypnol
SS
ORAL
Lofepramine
Hydrochloride
SS
ORAL
Toledomin
SS
ORAL
Diovan
SS
ORAL
Adalat
C
ORAL
Bayaspirin
C
ORAL
Herbesser "Tanabe"
C
ORAL
Nitroderm Tts
C
Duration
80 mg/day
99360MIN
160 mg/day
7200 MIN
40 mg/day
10080MIN
10 mg/day
25 mg/day
10 mg/day
1 mg/day
25 mg/day
25 mg/day
80 mg/day
40 mg/day
8640 MIN
100 mg, UNK
200 mg, UNK
TRANSDERMAL
10080MIN
50 mg/dat
Date:02/11/04ISR Number: 4294240-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031204142
Age:15 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
54 MG 1 IN 1
PT
Report Source
Product
Role
Abdominal Pain
Blood Creatine
Phosphokinase Increased
Blood Uric Acid Increased
Muscle Enzyme Increased
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
ORAL
Nausea
DAY ORAL
Renal Failure Acute
Vomiting
Docycyline
C
Date:02/12/04ISR Number: 4293858-0Report Type:Expedited (15-DaCompany Report #PHFR2003GB04698
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Asthenia
Hypokinesia
Health
Professional
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
5 mg, BID
Nasopharyngitis
Pain In Extremity
Paraplegia
Date:02/12/04ISR Number: 4295943-6Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040201870
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Amnesia
Bipolar Disorder
Childhood Psychosis
Drug Effect Decreased
Mania
Foreign
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
72 MG, 1 IN 1
Overdose
DAY, ORAL
18-Aug-2005
Page: 451
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/13/04ISR Number: 4294170-6Report Type:Expedited (15-DaCompany Report #PHEH2004US01627
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Ritalin La
PS
Novartis Sector:
Pharma
Albuterol
C
Route
Duration
Asthma
Tachycardia
20 mg, QD
UNK, PRN
Date:02/13/04ISR Number: 4297425-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040102092
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Decreased Appetite
Drug Ineffective
Fear
Hallucination, Visual
Headache
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Atropine Drops
(Atropine)
C
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Medication Error
Date:02/13/04ISR Number: 4297427-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202177
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Depression
Suicidal Ideation
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:02/16/04ISR Number: 4295347-6Report Type:Periodic
Age:
Gender:Female
I/FU:I
Outcome
Dose
PT
Duration
Company Report #US-GLAXOSMITHKLINE-A0413387A
Report Source
Product
Role
Manufacturer
Route
Other
Colitis
Lamictal
Ritalin
Date:02/16/04ISR Number: 4295863-7Report Type:Periodic
Age:
Gender:
I/FU:I
Outcome
Dose
PT
PS
SS
Glaxosmithkline
ORAL
Company Report #US-GLAXOSMITHKLINE-A0440866A
Report Source
Product
Role
Manufacturer
Route
Lamictal
Ritalin
PS
SS
Glaxosmithkline
ORAL
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Drug Interaction
Sedation
Date:02/17/04ISR Number: 4296344-7Report Type:Expedited (15-DaCompany Report #PHNU2004DE00823
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
400 mg,
PT
Agitation
General Physical Health
Deterioration
ONCE/SINGLE
Heart Rate Increased
Overdose
Poor Peripheral
Circulation
Tachycardia
18-Aug-2005
Page: 452
11:49 AM
Report Source
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/17/04ISR Number: 4299018-1Report Type:Expedited (15-DaCompany Report #2004007535
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
50 MG
PT
Report Source
Product
Role
Abnormal Behaviour
Consumer
Zoloft (Sertraline)
PS
Asthma
Emotional Disorder
Feeling Abnormal
Psychotic Disorder
Methylphenidate
Hydrochloride
(Methylphenidate
Hydrochloride)
SS
Screaming
Atomoxetine
Hydrochloride
(Atomoxetine
Hydrochloride)
SS
Manufacturer
Route
Duration
ORAL
Anger
(DAILY), ORAL
20 MG (DAILY)
36 MG (BID),
Salmeterol Xinafoate
(Salmeterol
Xinafoate)
Levothyroxine Sodium
(Levothyroxine
Sodium)
Bupropion
Hydrochloride
(Bypropion
Hydrochloride)
Fluticasone
Propionate
(Fluticasone
Propionate)
Salbutamol
(Salbutamol)
SS
C
C
C
C
Date:02/17/04ISR Number: 4299495-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040201307
Age:6 YR
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Hallucination
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Duration
Role
Manufacturer
Route
Sustained
PS
36 MG
Date:02/19/04ISR Number: 4299470-1Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0498217A
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
20MG At night
PT
Report Source
Product
Role
Manufacturer
Route
Abnormal Dreams
Paxil
PS
Glaxosmithkline
ORAL
Decreased Appetite
Metadate Cd
SS
ORAL
20MG In the
Hallucination
morning
1
YR
Insomnia
Muscle Twitching
Psychotic Disorder
Schizophrenia
Date:02/19/04ISR Number: 4301422-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040201255
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 453
PT
Report Source
Product
Hepatitis
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Duration
11:49 AM
Role
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Sustained Release
Tablets
PS
ORAL
54 MG, IN 1
DAY, ORAL
Date:02/20/04ISR Number: 4300540-XReport Type:Expedited (15-DaCompany Report #PHBS2004DK02324
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
Anxiety
Confusional State
40320MIN
Eye Movement Disorder
Date:02/20/04ISR Number: 4301926-XReport Type:Expedited (15-DaCompany Report #CEL-2003-04228-SLO
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Alanine Aminotransferase
Increased
Aspartate
Foreign
Health
Professional
Equasym 20mg
(Methylphenidate
Hydrochloride)
PS
ORAL
20 MG (20 MG,
Aminotransferase
DAILY), PO
Increased
Blood Creatine
Phosphokinase Increased
Blood Lactate
Dehydrogenase Increased
Viral Myositis
Date:02/20/04ISR Number: 4301973-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040203041
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Concussion
Vomiting
Health
Professional
Company
Concerta
(Methylphenidate
Hydrochloride)
Duration
Role
Manufacturer
Route
Representative
Sustained Release
Tablets
PS
ORAL
36 MG, 1 IN 1
DAY, ORAL
Date:02/20/04ISR Number: 4301978-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202455
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
ORAL;
PT
Report Source
Product
Role
Cholelithiasis
Decreased Appetite
Eating Disorder
Insomnia
Weight Gain Poor
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Methylphenidate
(Methylphenidate)
C
54 MG,
1 IN 1 DAY,
ORAL
18-Aug-2005
Page: 454
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/20/04ISR Number: 4302144-1Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040106204
Age:9 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abdominal Pain
Dehydration
Enterococcal Infection
Hypertension
Insomnia
Foreign
Study
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Clonidine
C
Manufacturer
Route
ORAL
54 MG 1 IN 1
Nausea
DAY ORAL
Psychomotor Hyperactivity
Urinary Tract Infection
Vomiting
White Blood Cell Count
Increased
Date:02/23/04ISR Number: 4302697-3Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Methylphenidate 5 Mg
Able Laboratories,
Inc
PS
Able Laboratories,
Inc
Product
Role
Manufacturer
Methylphenidate
Hydrochloride 20 Mg
Able Labratories,
Inc
PS
Able Laboratories,
Inc
Route
Duration
Pharmaceutical Product
Complaint
Sedation
Date:02/23/04ISR Number: 4302837-6Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #CTU 212870
PT
Company Report #CTU 212846
Report Source
Duration
Drug Ineffective
Route
Date:02/23/04ISR Number: 4303324-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030603419
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Blood Glucose Increased
Fall
Haematoma
Haemorrhage
Helicobacter Infection
Foreign
Consumer
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Medikinet
(Methylphenidate
Hydrochloride)
Tablets
C
1 TABLET
Idiopathic
DAILY
Thrombocytopenic Purpura
Mouth Haemorrhage
Nasopharyngitis
Petechiae
Pharyngolaryngeal Pain
Purulence
Road Traffic Accident
Thrombocytopenia
Traumatic Haematoma
18-Aug-2005
Page: 455
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:02/24/04ISR Number: 4302712-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE04286
Age:19 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
20 mg, BID
Other
PT
Report Source
Product
Role
Manufacturer
Route
Drug Dependence
Personality Disorder
Health
Professional
Ritalin-Sr
PS
Novartis Sector:
Pharma
ORAL
Sinquan
/Den/
C
ORAL
Date:02/24/04ISR Number: 4304573-9Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20040202794
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Neutrophil Count
Decreased
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Date:02/26/04ISR Number: 4304886-0Report Type:Periodic
Age:75 YR
Gender:Female
I/FU:I
Outcome
Dose
Route
PT
Company Report #US-GLAXOSMITHKLINE-A0491723A
Report Source
Product
Role
Manufacturer
Route
Abnormal Behaviour
Wellbutrin
PS
Glaxosmithkline
ORAL
Constipation
Dissociative Identity
Wellbutrin
Ritalin
SS
SS
Glaxosmithkline
ORAL
ORAL
Role
Manufacturer
Route
Duration
150MG Per day
14
Manufacturer
Duration
1
MON
MON
Disorder
Gallbladder Operation
Date:02/26/04ISR Number: 4305792-8Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 213275
Report Source
Product
Duration
Dyspepsia
Methylphenidate 5 Mg
Irritability
Nausea
Mfr-Sandoz Pharm
(Geneva)
PS
Sandoz Pharm
(Geneva)
ORAL
Route
5 MG PO BID
Date:02/27/04ISR Number: 4307089-9Report Type:Expedited (15-DaCompany Report #PHNR2004AU00583
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
30 mg, QD
PT
Report Source
Product
Role
Manufacturer
Ritalin La
PS
Novartis Sector:
Pharma
Ritalin
C
Duration
Epistaxis
1440 MIN
unspecified
Date:02/27/04ISR Number: 4307090-5Report Type:Expedited (15-DaCompany Report #PHBS2004BR01969
Age:24 YR
Gender:Male
I/FU:F
Outcome
Other
18-Aug-2005
Page: 456
PT
Aggression
Depression
Divorced
Dizziness
Irritability
Loss Of Employment
Physical Assault
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Treatment Noncompliance
Dose
Report Source
Product
Role
Manufacturer
Route
Consumer
Ritalina
PS
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Manufacturer
Route
Duration
1 tablet, BID
Ritalina
SS
1 tablet/day
Ritalina
SS
3 tablets/day
Ritalina
SS
2 tablets/day
Date:02/27/04ISR Number: 4308855-6Report Type:Expedited (15-DaCompany Report #MK200402-0235-1
Age:23 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Cardiac Arrest
Loss Of Consciousness
Pancreatic Pseudocyst
Pancreatitis Acute
Foreign
Anafranil Capsules
Melleril
Lexotan
Pyrethia
Vegetamin A
Hirnamin
Isomytal
Halcion
Ritalin
PS
SS
SS
SS
SS
SS
SS
SS
SS
Date:03/01/04ISR Number: 4308498-4Report Type:Expedited (15-DaCompany Report #99J--10250
Age:23 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization UNKNOWN
Initial or Prolonged
UNKNOWN
UNKNOWN
PT
Report Source
Product
Role
Cardiac Arrest
1440 MIN
Cardiac Fibrillation
1440 MIN
Coma
Health
Melleril
PS
Professional
Anafranil
SS
Lexotan
SS
Electrocardiogram
Pyrethia
SS
Abnormal
Vegetamin A
SS
Hypothermia
Hirnamin
SS
Inflammation
Isomytal
SS
Loss Of Consciousness
1440 MIN
Multiple Drug Overdose
1440 MIN
Mydriasis
Oedema
Overdose
Pancreatic Pseudocyst
Pancreatitis Acute
Pupillary Reflex Impaired
Suicide Attempt
Halcion
SS
Ritalin
SS
UNKNOWN
UNKNOWN
UNKNOWN
UNKNOWN
UNKNOWN
UNKNOWN
Date:03/01/04ISR Number: 4309700-5Report Type:Expedited (15-DaCompany Report #MK200402-0202-1
Age:22 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
10 MG, BID
PT
Report Source
Product
Role
Nausea
Paraesthesia
Consumer
Methylphenidate Hcl
Tabs, Usp. 10mg
PS
Pyrexia
Rash
18-Aug-2005
Page: 457
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/02/04ISR Number: 4310829-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040203651
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Urine
Renal Pain
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Manufacturer
Route
Duration
SEE IMAGE
Date:03/02/04ISR Number: 4310872-7Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040204255
Age:7 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abnormal Behaviour
Bipolar Disorder
Drug Interaction
Hallucination, Auditory
Mood Swings
Foreign
Study
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
Celexa (Citalopram
Hydrobromide)
SS
ORAL
54 MG, 1 IN 1
DAY, ORAL
10 MG, 2 IN 1
DAY, ORAL
Risperidone
(Risperidone)
Ditropan Ir
(Oxybutynin
Hydrochloride)
C
C
Date:03/03/04ISR Number: 4310428-6Report Type:Expedited (15-DaCompany Report #PHBS1999JP03379
Age:23 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Abdominal Pain
Cardiac Arrest
Health
Professional
Melleril
(Thioridazine
Role
Manufacturer
Route
UNKNOWN
UNKNOWN
UNKNOWN
UNKNOWN
UNKNOWN
UNKNOWN
Cardiac Fibrillation
UNSPECIFIED
1440 MIN
Electrocardiogram
UNSPECIFIED
1440 MIN
Abnormal
UNSPECIFIED
1440 MIN
Hypothermia
Loss Of Consciousness
Mydriasis
UNSPECIFIED
1440 MIN
Overdose
Pancreatic Pseudocyst
UNSPECIFIED
1440 MIN
Pancreatitis Acute
Pupillary Reflex Impaired
UNSPECIFIED
1440 MIN
UNKNOWN
UNSPECIFIED
1440 MIN
UNKNOWN
UNSPECIFIED
1440 MIN
UNKNOWN
UNSPECIFIED
1440 MIN
Hydrochloride)
PS
Anafranil
SS
Lexotan (Bromazepam)
SS
Pyrethia
(Promethazine
Hydrochloride)
SS
Vegetamin-A
(Vegetamin A)
SS
Hirnamin
(Levomepromazine)
SS
Isomytal
(Amobarbital)
SS
Halcion (Triazolam)
SS
Ritalin
SS
Date:03/03/04ISR Number: 4311943-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040206108
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG, IN 1
18-Aug-2005
Page: 458
PT
Report Source
Product
Role
Blood Creatine
Phosphokinase Increased
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablet
PS
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
DAY, ORAL
Date:03/04/04ISR Number: 4311745-6Report Type:Direct
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Required
ONE DOSE
Intervention to
DAILY
Prevent Permanent
ONE DOSE Q AM
Impairment/Damage
PT
Company Report #CTU 213852
Report Source
Trichotillomania
Product
Role
Strattera 60 Mg
PS
Ritalin La 20 Mg
SS
Manufacturer
Route
Manufacturer
Route
Date:03/04/04ISR Number: 4313184-0Report Type:Expedited (15-DaCompany Report #CEL-2004-00224-ROC
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
Required
Intervention to
Prevent Permanent
40 MG QAM
Impairment/Damage
PT
Report Source
Product
Role
Abnormal Behaviour
Grand Mal Convulsion
Incoherent
Postictal State
Health
Professional
Company
Representative
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Metadate Er Tablets
10mg (Methylphnidate
Hydrochloride)
SS
Thinking Abnormal
10 MG QD
Date:03/08/04ISR Number: 4313671-5Report Type:Expedited (15-DaCompany Report #PHBS2004BR01969
Age:24 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Aggression
Depression
Ritalina
PS
Novartis Sector:
Pharma
ORAL
Dizziness
Irritability
Ritalina
Novartis Sector:
Pharma
ORAL
Duration
1 tablet, BID
1 tablet/day
SS
Ritalina
SS
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
3 tablets/day
Ritalina
SS
2 tablets/day
Date:03/08/04ISR Number: 4314090-8Report Type:Direct
Age:15 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Life-Threatening
PT
Company Report #CTU 214038
Report Source
Idiopathic
Thrombocytopenic Purpura
Product
Role
Manufacturer
Route
Methylphenidate
Methylin-20 Mg Tab
Mallinkckro
PS
Mallinkckro
ORAL
Product
Role
Manufacturer
Route
D-Threo-Methylphenid
ate Hcl (D-Mph)
PS
Radiation
Temodar
C
C
2 1/2 DAILY
ORAL
Date:03/10/04ISR Number: 4315319-2Report Type:Direct
Age:52 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
15 MG BID 1
PT
Febrile Neutropenia
Pneumonia
Company Report #CTU 214234
Report Source
PO
18-Aug-2005
Page: 459
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/10/04ISR Number: 4315325-8Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 214246
Report Source
Product
Role
Adderall Generic And
Brand Name
PS
Concerta
SS
Strattera
SS
Manufacturer
Route
Route
Duration
Drug Ineffective
Pharmaceutical Product
5 MG
Complaint
INCREASED TO
20
18 INCREASING
TO 54
Date:03/10/04ISR Number: 4315477-XReport Type:Direct
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
TAKE 1 TABLET
PT
Company Report #CTU 214226
Report Source
Abnormal Behaviour
Product
Role
Manufacturer
Concerta Er
PS
Alza
Claritin
C
Pharmaceutical Product
EVERY MORNING
Complaint
Date:03/10/04ISR Number: 4315723-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040300344
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Anxiety
Fear
Hallucination, Visual
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Duration
SEE IMAGE
Sleep Disorder
Manufacturer
Route
Date:03/10/04ISR Number: 4315727-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040300560
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hallucination
Nightmare
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Duration
Date:03/10/04ISR Number: 4315837-7Report Type:Expedited (15-DaCompany Report #MK200402-0235-2
Age:23 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
ONE TIME DOSE
PT
Report Source
Product
Role
Cardiac Arrest
Cardiac Fibrillation
Foreign
Health
Anafranil Capsules
Melleril
PS
SS
Hypothermia
Professional
Lexotan
SS
Loss Of Consciousness
Other
Pyrethia
SS
Mydriasis
Vegetamin A
SS
Oedematous Pancreatitis
Hirnamin
SS
Overdose
Isomytal
SS
Pancreatic Pseudocyst
Halcion
SS
Pancreatitis Acute
Ritalin
SS
ONE TIME DOSE
ONE TIME DOSE
ONE TIME DOSE
ONE TIME DOSE
ONE TIME DOSE
ONE TIME DOSE
ONE TIME DOSE
Pupil Fixed
Suicide Attempt
18-Aug-2005
Page: 460
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/11/04ISR Number: 4315619-6Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0502000A
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Anger
Depression
Diabetes Mellitus
Fear
Feeling Abnormal
Homicidal Ideation
Hypertension
Nightmare
Suicidal Ideation
Suicide Attempt
Product
Role
Manufacturer
Route
Paxil
Zoloft
Effexor
Ritalin
PS
SS
SS
SS
Glaxosmithkline
ORAL
ORAL
ORAL
ORAL
Manufacturer
Route
Date:03/11/04ISR Number: 4316851-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040206433
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Suicide Attempt
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
18 MG, 1 IN 1
DAY, ORAL
Date:03/12/04ISR Number: 4316039-0Report Type:Expedited (15-DaCompany Report #99J--10250
Age:23 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization UNKNOWN
Initial or Prolonged
UNKNOWN
PT
Report Source
Product
Role
Cardiac Arrest
1440 MIN
Cardiac Fibrillation
1440 MIN
Electrocardiogram
Melleril
PS
Anafranil
SS
Lexotan
SS
Abnormal
Pyrethia
SS
UNKNOWN
UNKNOWN
Manufacturer
Route
Hypothermia
Vegetamin A
SS
Loss Of Consciousness
Hirnamin
SS
Multiple Drug Overdose
Isomytal
SS
Mydriasis
1440 MIN
Oedema
1440 MIN
Overdose
Pancreatic Pseudocyst
Pancreatitis Acute
Pupillary Reflex Impaired
Suicide Attempt
Halcion
SS
Ritalin
SS
UNKNOWN
UNKNOWN
UNKNOWN
UNKNOWN
UNKNOWN
Date:03/12/04ISR Number: 4317155-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030603419
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Fall
Haematoma
Iron Deficiency
Petechiae
Skin Haemorrhage
Foreign
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Mediknet
(Methylphenidate
Hydrochloride)
Tablet
C
1 TABLET
Thrombocytopenia
DAILY
18-Aug-2005
Page: 461
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/12/04ISR Number: 4317158-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040301164
Age:34 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Chest Discomfort
Heart Rate Increased
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
Ritalin
(Methylphenidate
Hydrochloride)
Unknown
PS
Manufacturer
Route
Route
Duration
C
Date:03/15/04ISR Number: 4317741-7Report Type:Expedited (15-DaCompany Report #PHHO2004CH03334
Age:54 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Aggression
Drug Level Decreased
Methylphenidate
PS
Novartis Sector:
Pharma
Drug Level Increased
Remeron
SS
Irritability
Becozym
Benerva
C
C
Orfiril
C
Duration
10 mg, UNK
15 mg, QD
23040MIN
300 mg, QD
900 mg, QD
34560MIN
Date:03/15/04ISR Number: 4318196-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040200246
Age:7 YR
Gender:Female
I/FU:F
Outcome
Dose
PT
Report Source
Product
Role
Glaucoma
Consumer
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
18 MG, 1 IN 1
ORAL
DAY, ORAL
Date:03/16/04ISR Number: 4317807-1Report Type:Expedited (15-DaCompany Report #PHBS2004BR02935
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritalina
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
Agitation
Developmental Delay
2.5
Eosinophil Count
tablets/day
Increased
Growth Retardation
Insomnia
Skin Odour Abnormal
Tooth Disorder
Vomiting
Weight Gain Poor
Date:03/16/04ISR Number: 4318475-5Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
TWO AM, NOON
PT
Drug Resistance
Pharmaceutical Product
, 3 PM PO
Complaint
18-Aug-2005
Page: 462
11:49 AM
Company Report #CTU 214446
Report Source
Product
Role
Ritalin 20 Mg
PS
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/17/04ISR Number: 4320336-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040301166
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Dyspnoea
Tachycardia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
36 MG
Date:03/19/04ISR Number: 4320565-8Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #CTU 214836
Report Source
Product
Role
Adderall Xr
Ritalin La 20 Mg
PS
SS
Duration
Hallucination, Visual
Pharmaceutical Product
Complaint
Date:03/19/04ISR Number: 4322060-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040302317
Age:9 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Drug Ineffective
Erythema
Heart Rate Increased
Initial Insomnia
Medication Error
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
18 MG, 1 IN 1
Psychomotor Hyperactivity
DAY, ORAL;
Rash
27 MG, 1 IN 1
Urinary Incontinence
DAY, ORAL;
Prevacid
(Lansoprazole)
Albuterol
(Salbutamol)
Atrovent
C
C
ORAL
(Ipratropium
Bromide)
C
Date:03/22/04ISR Number: 4321088-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE00635
Age:39 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Abortion Induced
Anxiety
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Complications Of Maternal
Exposure To Therapeutic
Trevilor - Slow
Release
Duration
60 mg/day
450 mg/day
Drugs
Condition Aggravated
Depressive Symptom
Maternal Drugs Affecting
Foetus
Pregnancy
18-Aug-2005
Page: 463
11:49 AM
C
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/22/04ISR Number: 4322289-XReport Type:Direct
Age:63 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization 15 MG PO BID
Initial or Prolonged
PT
Product
Role
Manufacturer
Route
Agitation
D-Mph 5 Mg Celgene
PS
Celgene
ORAL
Disorientation
Mental Status Changes
Thrombocytopenia
Urinary Tract Infection
Decadron
Zoloft
Detrol La
Xanax
Celebrax
Ambien
Diflucan
Cipro
C
C
C
C
C
C
C
C
Manufacturer
Route
Date:03/22/04ISR Number: 4322291-8Report Type:Direct
Age:45 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 5 MG ONE BID
Initial or Prolonged
INCREASED TO
Company Report #CTU 214981
PT
Report Source
Company Report #CTU 214979
Report Source
Mass
Product
Role
D-Mph 5 Mg Tablets
PS
Mental Status Changes
Neoplasm
THREE BID
Nuclear Magnetic
Resonance Imaging
Abnormal
Date:03/22/04ISR Number: 4322293-1Report Type:Direct
Age:60 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 15 MG BID PO
Initial or Prolonged
PT
Company Report #CTU 214978
Report Source
Product
Role
Manufacturer
Route
Convulsion
D-Mph 5 Mg -Celgene
PS
Celgene
ORAL
Depression
Disease Recurrence
Mental Status Changes
Celebrax
Dilantin
Decadron
.
Imiprazole
C
C
C
C
C
Zantac
Date:03/22/04ISR Number: 4322294-3Report Type:Direct
Age:52 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
15 MG BID /PO
PT
Outcome
Dose
Duration
Hospitalization 15 MG BID PO
Initial or Prolonged
18-Aug-2005
Page: 464
11:49 AM
Company Report #CTU 214977
Report Source
Febrile Neutropenia
Pneumonia
Date:03/22/04ISR Number: 4322297-9Report Type:Direct
Age:63 YR
Gender:Female
I/FU:I
PT
C
Product
Role
D-Threo-Methylphenid
ate Hic (D-Mph)
PS
Temodar
Rt
C
C
Manufacturer
Route
ORAL
Company Report #CTU 214976
Report Source
Product
Role
Manufacturer
Route
Abnormal Behaviour
D-Mph 5 Mg Celgene
PS
Celgene
ORAL
Agitation
Hallucination, Visual
Insomnia
Treatment Noncompliance
Zoloft
Decadron
Detrol
Xanax
Celebrex
Ambien
Blinded Study Drug
C
C
C
C
C
C
C
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/22/04ISR Number: 4324653-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040302004
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Aggression
Drug Ineffective
Food Craving
Self Esteem Inflated
Suicidal Ideation
Foreign
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
36 MG, IN 1
DAY, ORAL
Date:03/23/04ISR Number: 4323752-8Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040204255
Age:7 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abnormal Behaviour
Anger
Bipolar Disorder
Crying
Decreased Appetite
Foreign
Study
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
Celexa (Citalopram
Hydrobromide)
SS
ORAL
Manufacturer
Route
54 MG, 1 IN 1
Drug Interaction
DAY, ORAL
Hallucination, Auditory
Homicidal Ideation
10 MG, 3 IN 1
Mood Swings
DAY, ORAL
Nausea
Vomiting
Risperidone
(Risperidone)
Ditropan Ir
(Oxybutynin
Hydrochloride)
C
C
Date:03/23/04ISR Number: 4323753-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040302348
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Other
Eosinophilia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
18 MG, IN 1
DAY, ORAL
Date:03/23/04ISR Number: 4323754-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040302601
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 465
PT
Report Source
Product
Abnormal Dreams
Hallucination
Post Procedural
Complication
Skin Laceration
Foreign
Health
Professional
Concerta Xl
(Methylphenidate
Hydrochloride)
Cefuroxime
(Cefuroxime)
Ondansetron
(Ondansetron)
Paracetamol
(Paracetamol)
Diclofenac
(Diclofenac)
Cyclizine
(Cyclizine)
Co-Codamol
Role
Duration
11:49 AM
PS
C
C
C
C
C
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
(Panadeine Co)
C
Date:03/23/04ISR Number: 4323756-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040303081
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Aspartate
Aminotransferase
Increased
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
36 MG, IN 1
Eosinophilia
DAY, ORAL
Date:03/23/04ISR Number: 4323757-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030603419
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
1 TABLET
PT
Report Source
Product
Role
Biopsy Bone Marrow
Abnormal
Blood Glucose Increased
Foreign
Consumer
Health
Concerta
(Methylphenidate
Hydrochloride)
PS
Glucose Urine Present
Professional
Helicobacter Infection
Hyperplasia
Iron Deficiency
Nasopharyngitis
Petechiae
Pharyngolaryngeal Pain
Poikilocytosis
Purulence
Skin Haemorrhage
Thrombocytopenia
Other
Medikinet
(Methylphenidate
Hydrochloride)
C
Manufacturer
Route
Route
/DAILY
Date:03/25/04ISR Number: 4322971-4Report Type:Expedited (15-DaCompany Report #PHBS2004BR03858
Age:
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Ritalina
PS
Novartis Sector:
Duration
Completed Suicide
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
40 mg/day
Ritalina
SS
30 mg/day
Ritalina
SS
20 mg/day
Sertraline
UNKNOWN
C
25 to 50
mg/day
Date:03/25/04ISR Number: 4327846-2Report Type:Expedited (15-DaCompany Report #PT-JNJFOC-20040302154
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG, IN 1
DAY, ORAL
18-Aug-2005
Page: 466
PT
Report Source
Product
Role
Back Pain
Chest Pain
Delusion
Diplopia
Headache
Foreign
Health
Professional
Other
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:03/29/04ISR Number: 4330576-4Report Type:Expedited (15-DaCompany Report #CEL-2004-00320-ROC
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
Required
Intervention to
Prevent Permanent
Impairment/Damage
60MG
PT
Report Source
Product
Role
Depressed Level Of
Consciousness
Incontinence
Postictal State
Somnolence
Health
Professional
Metadate Cd Capsules
(Strength
Unspecified)
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Date:03/29/04ISR Number: 4331403-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040304100
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Cerebral Haemorrhage
Cerebrovascular Accident
Headache
Hemiplegia
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Remeron (Mitazapine)
C
ORAL
54 MG, 1 IN 1
DAY, ORAL
Date:03/29/04ISR Number: 4336843-2Report Type:Periodic
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
25 MG/DAY
Company Report #USA040156295
PT
Report Source
Product
Role
Disturbance In Attention
Psychomotor Hyperactivity
Tic
Consumer
Strattera
(Atomoxetine
Hydrochloride)
PS
Concerta(Methylpheni
date Hydrochloride)
I
Duration
6
WK
Date:03/30/04ISR Number: 4332568-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040101912
Age:13 YR
Gender:Male
I/FU:F
Manufacturer
Route
Outcome
Dose
Other
36 MG,
PT
Report Source
Product
Role
Iron Deficiency Anaemia
Leukopenia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:03/30/04ISR Number: 4332569-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040201307
Age:6 YR
Gender:Unknown
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Hallucination, Visual
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
36 MG
Date:03/30/04ISR Number: 4332570-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040201665
Age:11 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 467
PT
Anorexia
Gynaecomastia
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Insomnia
Weight Decreased
Dose
Report Source
Product
Role
Foreign
Health
Professional
Concerta Xl
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
54 MG, ORAL
Date:03/31/04ISR Number: 4331141-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040203041
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Concussion
Head Injury
Malabsorption
Vomiting
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
DAY, ORAL
Clonidine
(Clonidine) Tablets
Ritalin
(Methylphenidate
Hydrochloride)
C
C
Date:03/31/04ISR Number: 4332112-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040305787
Age:
Gender:
I/FU:I
Outcome
Dose
Other
ORAL
PT
Report Source
Product
Role
Depressive Symptom
Suicidal Ideation
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
Date:03/31/04ISR Number: 4332113-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040305786
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Depressive Symptom
Suicidal Ideation
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:03/31/04ISR Number: 4332116-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040304599
Age:12 YR
Gender:
I/FU:I
Outcome
Dose
Other
54 MG,
UNKNOWN
18-Aug-2005
Page: 468
PT
Report Source
Product
Role
Blindness Transient
Blindness Unilateral
Colour Blindness Acquired
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Duration
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/01/04ISR Number: 4333345-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040104848
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Asthenia
Loss Of Consciousness
Tachycardia
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
Zoloft (Sertraline
Hydrochloride)
SS
ORAL
Duration
54 MG, 1 IN 1
DAY, ORAL
25 MG, ORAL
Date:04/02/04ISR Number: 4333770-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040304857
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Haematuria
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Manufacturer
Route
Manufacturer
Route
Duration
54 MG, IN 1
DAY
Date:04/02/04ISR Number: 4333771-3Report Type:Expedited (15-DaCompany Report #DK-JNJFOC-20040304590
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
36 MG, IN 1
DAY, ORAL
PT
Report Source
Product
Role
Henoch-Schonlein Purpura
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Talbets
PS
ORAL
Date:04/02/04ISR Number: 4333773-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031105477
Age:15 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Abortion Spontaneous
Complications Of Maternal
Exposure To Therapeutic
Drugs
Maternal Drugs Affecting
Foreign
Health
Professional
Concerta Xl
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
54 MG, IN 1
Foetus
DAY, ORAL
Unintended Pregnancy
Date:04/02/04ISR Number: 4337205-4Report Type:Periodic
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 469
Company Report #PHEH2004US01439
PT
Report Source
Product
Anxiety
Confusional State
Drug Abuser
Fatigue
Headache
Lethargy
Consumer
Ritalin La
(Methylphenidate
Hydrochloride)
Extended Release
Capsules
Accutane
(Isotretinoin)
Over The Conter
Role
Duration
11:49 AM
PS
C
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Antihistamines
C
Date:04/05/04ISR Number: 4331504-8Report Type:Expedited (15-DaCompany Report #PHNU2004DE01402
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritalin-Sr
PS
Novartis Sector:
Pharma
ORAL
Route
Duration
Facial Paresis
Date:04/05/04ISR Number: 4331621-2Report Type:Expedited (15-DaCompany Report #PHBS2004BR04217
Age:69 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
UNKNOWN
UNKNOWN
UNKNOWN
PT
Report Source
Product
Role
Manufacturer
Health
Professional
Methylphenidate
PS
Novartis Sector:
Pharma
Methylphenidate
SS
Novartis Sector:
Pharma
Sertraline
C
Duration
Apathy
Confusional State
5 mg/day
Crying
Hypersomnia
2.5 mg/day
Respiratory Depression
50 mg/day
Respiratory Failure
Date:04/05/04ISR Number: 4334745-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040306437
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
27 MG ORAL
PT
Report Source
Product
Role
Blood Pressure Increased
Headache
Health
Professional
Company
Concerta
(Methylphenidate
Hydrochloride)
PS
Representative
Risperdal
(Risperidone)
C
Date:04/05/04ISR Number: 4334746-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040306436
Age:10 YR
Gender:Male
I/FU:I
Manufacturer
Route
ORAL
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Pressure Increased
Dizziness
Headache
Health
Professional
Company
Concerta
(Methylphenidate
Hydrochloride)
PS
Risperdal
(Risperidone)
C
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
Representative
DAY, ORAL; 27
MG, 1 IN 1
DAY, ORAL; 18
MG, 1 IN 1
Date:04/05/04ISR Number: 4334747-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040304599
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Blindness Transient
Blindness Unilateral
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
54 MG ORAL
Other
18-Aug-2005
Page: 470
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/05/04ISR Number: 4334819-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040305776
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Psychotic Disorder
Suicidal Ideation
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
36 MG, IN 1
DAY, ORAL
Date:04/06/04ISR Number: 4333699-9Report Type:Direct
Age:49 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
150 MG
PT
Company Report #CTU 216062
Report Source
Product
Role
Effexor 150 Mg
PS
Concerta 27 Mg
SS
Risperdal
Synthroid
Atkins Diet
C
C
C
Manufacturer
Route
Manufacturer
Route
Duration
Intentional Self-Injury
NIGHTLY
27 MG DAILY +
Date:04/07/04ISR Number: 4334699-5Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Life-Threatening
1 DAY ORAL
PT
Company Report #CTU 216102
Report Source
Product
Role
Hair Plucking
Paxil
Intentional Self-Injury
Concerta
1 DAY ORAL
Self Injurious Behaviour
Suicidal Ideation
20 Mg
35 Mg
PS
ORAL
SS
ORAL
Date:04/07/04ISR Number: 4336343-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040306782
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Dyspnoea
Oesophageal Spasm
Oesophagitis
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Dexmethylphenidate
Hydrochloride
(Methylphenidate)
C
Manufacturer
Route
Duration
ORAL
108 MG, 1IN 1
DAY, ORAL
Date:04/08/04ISR Number: 4335301-9Report Type:Direct
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Ritalin (Sr) 20 Mg 1
Po Qd
PS
Manufacturer
Route
Duration
Drug Effect Decreased
1 PO QD
18-Aug-2005
Page: 471
Company Report #CTU 216204
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/08/04ISR Number: 4337854-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040400309
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Aggression
Oral Intake Reduced
Urticaria
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Oxybutynin
Methylphenidate
C
C
Manufacturer
Route
Duration
ORAL
1 DOSE (S), 1
IN 1 DAY,
ORAL
Date:04/09/04ISR Number: 4335446-3Report Type:Expedited (15-DaCompany Report #PHBS2004BE04601
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Pharma
Route
Duration
Dependence
Date:04/09/04ISR Number: 4338458-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040400865
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Abnormal Dreams
Hallucination
Insomnia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Melatonin (Tablets)
C
Manufacturer
Route
Duration
18 MG, 1 IN 1
DAY, ORAL
ORAL
Date:04/09/04ISR Number: 4338460-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040305396
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Alanine Aminotransferase
Increased
Cyanosis
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
18 MG, IN 1
DAY, ORAL
Date:04/09/04ISR Number: 4338461-9Report Type:Expedited (15-DaCompany Report #PT-JNJFOC-20040400024
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Body Temperature
Decreased
Cyanosis
Difficulty In Walking
Pain In Extremity
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
Paraesthesia
Vascular Occlusion
18-Aug-2005
Page: 472
11:49 AM
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/09/04ISR Number: 4338462-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040303081
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Aspartate
Aminotransferase
Increased
Eosinophilia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
PS
Manufacturer
Route
Duration
ORAL
36 MG, IN 1
DAY, ORAL
Date:04/09/04ISR Number: 4338469-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040303304
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Chest Pain
Circulatory Collapse
Dyspnoea
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
54 MG, 1 IN 1
Pain In Extremity
DAY, ORAL
Pallor
Date:04/14/04ISR Number: 4338655-2Report Type:Expedited (15-DaCompany Report #PHNU2004DE01468
Age:11 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Aplastic Anaemia
Biopsy Bone Marrow
1095 DAY
Abnormal
Pancytopenia
Date:04/14/04ISR Number: 4340628-0Report Type:Expedited (15-DaCompany Report #CEL-2004-00589-ROC
Age:16 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abdominal Pain
Chest Pain
Drug Ineffective
Headache
Consumer
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
20MG ONCE PO
Hyperventilation
Hypoaesthesia
Joint Stiffness
Palpitations
Ditropan
(Oxybutynin)
Sudafed
(Pseudoephedrine
Hydrochloride)
C
C
Date:04/15/04ISR Number: 4339419-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE01472
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Myocardial Infarction
Date:04/15/04ISR Number: 4339855-8Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
TWO DAILY
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
PT
Company Report #CTU 216731
Report Source
Product
Role
Ritalin Sr 20 Mg
PS
ORAL
Ritalin 10 Mg
SS
ORAL
Duration
Migraine
Pharmaceutical Product
ORAL
1
YR
Complaint
TWO DAILY
18-Aug-2005
Page: 473
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
ORAL
1
YR
Date:04/15/04ISR Number: 4340039-8Report Type:Direct
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 216720
Report Source
Product
Role
Ritalin
(Methylphenidate )
Generic
PS
Manufacturer
Route
Duration
Pharmaceutical Product
Complaint
Rash
15 GM Q 4 PRN
Date:04/19/04ISR Number: 4341108-9Report Type:Expedited (15-DaCompany Report #PHEH2004US02905
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Disability
PT
Report Source
Product
Role
Manufacturer
Route
Ritalin-Sr
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Manufacturer
Route
Duration
Movement Disorder
Throat Irritation
20 mg, QD
Tic
Date:04/19/04ISR Number: 4343669-2Report Type:Expedited (15-DaCompany Report #CEL-2003-04227-ROC
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Other
Required
Intervention to
Prevent Permanent
Impairment/Damage
PT
Report Source
Product
Role
Psychotic Disorder
Health
Professional
Company
Representative
Metadate Cd Capsules
(Strength
Unspecified)
(Methylphenidate
Hydrochloride)
PS
Date:04/19/04ISR Number: 4343732-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040200827
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Anxiety
Consumer
Concerta
Duration
Role
Crying
Depressed Mood
Fear
Head Injury
Health
Professional
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
18 MG, 1 IN 1
Insomnia
DAY, ORAL
Nervousness
Pressure Of Speech
Suicidal Ideation
Date:04/21/04ISR Number: 4345216-8Report Type:Direct
Age:42 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Ritalin La 30 Mg
Novaritis
PS
Novaritis
Duration
Abnormal Behaviour
Activities Of Daily
1 CAPSUL
Living Impaired
MORNING
Feeling Abnormal
Paranoia
Staring
Suicidal Ideation
18-Aug-2005
Page: 474
Company Report #CTU 217150
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/22/04ISR Number: 4347965-4Report Type:Expedited (15-DaCompany Report #PHEH2004US02905
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Movement Disorder
Throat Irritation
Tic
Health
Professional
Ritalin-Sr(Methylphe
nidate
Hydrochloride) Slow
Release Tablet
PS
Manufacturer
Route
Duration
ORAL
20 MG,
QD,ORAL
Date:04/26/04ISR Number: 4349407-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040301164
Age:34 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Chest Discomfort
Dyspnoea
Heart Rate Increased
Palpitations
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Release Tablets
PS
Manufacturer
Route
Duration
ORAL
90 MG, IN 1
DAY, ORAL
Date:04/27/04ISR Number: 4348366-5Report Type:Expedited (15-DaCompany Report #PHBS2004BR02935
Age:7 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritalina
PS
Novartis Sector:
Pharma
ORAL
Duration
Agitation
Asthma
2.5
Developmental Delay
tablets/day
Eosinophil Count
Increased
Growth Retardation
Headache
Insomnia
Penis Disorder
Skin Odour Abnormal
Polivitamine
Revitam Jr
C
C
Testicular Retraction
Tooth Disorder
Vomiting
Weight Gain Poor
Date:04/27/04ISR Number: 4348378-1Report Type:Expedited (15-DaCompany Report #PHEH2004US04276
Age:35 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Ritalin La
PS
Novartis Sector:
Pharma
Wellbutrin
Serzone
Allegra-D
C
C
/01367401/
C
Route
Duration
Depression Suicidal
20 mg, QD
Date:04/27/04ISR Number: 4348971-6Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Report Source
Product
Role
Ritalin
Concerta
Adderal
PS
SS
SS
Duration
Decreased Appetite
Drug Effect Decreased
Tic
18-Aug-2005
Page: 475
Company Report #CTU 217488
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/27/04ISR Number: 4350817-7Report Type:Expedited (15-DaCompany Report #CEL-2004-00656-ROC
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Hepatic Failure
Health
Professional
Company
Representative
Metadate Cd Capsules
(Strength
Unspecified)
(Methylphenidate
Hydrochloride)
PS
Methylphenidate
(Brand Unspecified )
Methylphenidate
SS
Manufacturer
Route
40MG ONCE
DAILY
;
SEVERAL YEARS
AGO
10 MG
FREQUENCY AND
ROUTE UNKNOWN
Date:04/28/04ISR Number: 4349418-6Report Type:Expedited (15-DaCompany Report #PHBS2004BE04601
Age:
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Duration
Dependence
Drug Abuser
150 mg/day
Ritaline
SS
60 mg/day
Prozac
UNKNOWN
Date:04/28/04ISR Number: 4351507-7Report Type:Expedited (15-DaCompany Report #CEL-2004-00675-ROC
Age:26 YR
Gender:Male
I/FU:I
C
Outcome
Dose
Duration
Other
Required
Intervention to
Prevent Permanent
20MG DAILY PO
Impairment/Damage
PT
Report Source
Product
Role
Facial Palsy
Muscle Twitching
Tympanic Membrane
Perforation
Consumer
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
Date:04/28/04ISR Number: 4352177-4Report Type:Expedited (15-DaCompany Report #CEL-2004-00330-SLO
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Initial Insomnia
Paradoxical Drug Reaction
Tic
Foreign
Health
Professional
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
20 MG ONCE
DAILY, ORALLY
Ritalin
(Methylphenidate
Hydrochloride)
Clonidine
(Clonidine)
18-Aug-2005
Page: 476
Manufacturer
Route
Duration
11:49 AM
C
C
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:04/29/04ISR Number: 4353060-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040404867
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Dyskinesia
Foreign
Health
Professional
Concerta(Methylpheni
date Hydrochloride )
Sustained Release
Tablets
PS
Catapresan
(Clonidine)
C
Manufacturer
Route
Duration
ORAL
18 MG, IN 1
DAY, ORAL
Date:04/30/04ISR Number: 4352687-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040405349
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abnormal Behaviour
Alcohol Poisoning
Legal Problem
Physical Assault
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Antidepressant
(Antidepressants)
SS
Manufacturer
Route
ORAL
SEE IMAGE
Date:04/30/04ISR Number: 4352688-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040405591
Age:21 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
54 MG, 1 IN 1
DAY, ORAL
PT
Report Source
Product
Role
Hypertension
Palpitations
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained
PS
Manufacturer
Route
Duration
ORAL
Date:04/30/04ISR Number: 4353380-XReport Type:Expedited (15-DaCompany Report #CEL-2004-00656-ROC
Age:8 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Life-Threatening
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Hepatic Failure
Health
Professional
Company
Representative
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
ORAL
Methylphenidate
(Brand Unspecified)
(Methylphenidate)
SS
ORAL
40 MG QAM PO
10 MG DAILY
PO
Date:05/04/04ISR Number: 4352632-7Report Type:Expedited (15-DaCompany Report #PHEH2004US04593
Age:72 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Medication Error
Movement Disorder
Ritalin
PS
Novartis Sector:
Pharma
Sudden Death
Clozapine
SS
Compazine
Percocet
Paxil
SS
SS
C
Duration
20 mg, BID
200 mg, QHS
50 mg, QD
(50mg QAM)
18-Aug-2005
Page: 477
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Ativan
C
1 mg, TID
Date:05/04/04ISR Number: 4352724-2Report Type:Expedited (15-DaCompany Report #04-03-0377
Age:72 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Compazine
Clozapine
PS
SS
Glaxosmithkline
Ritalin
SS
Percocet
Paxil Cr
Ativan
SS
C
C
Route
Duration
Death
ORAL
200MG At
night
ORAL
20MG Twice
per day
Glaxosmithkline
ORAL
ORAL
Manufacturer
Route
1MG Three
times per day
Date:05/04/04ISR Number: 4355363-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040405168
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Inner Ear Disorder
Nausea
Nystagmus
Vertigo
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
36 MG, 1 IN 1
DAY, ORAL
Date:05/04/04ISR Number: 4355365-6Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20040400872
Age:16 YR
Gender:Male
I/FU:I
ORAL
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Agitation
Burns Second Degree
Hypoaesthesia Oral
Insomnia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Manufacturer
Route
ORAL
ORAL
Logorrhoea
Memory Impairment
Muscle Twitching
Mydriasis
Overdose
Self Mutilation
Vision Blurred
Date:05/06/04ISR Number: 4353919-4Report Type:Periodic
Age:17 YR
Gender:Female
I/FU:I
Outcome
Dose
PT
Company Report #20030906351
Report Source
Urticaria
3
Product
Role
Manufacturer
Route
Amoxillin
PS
Glaxosmithkline
ORAL
Concerta
SS
Duration
DAY
18MG Per day
ORAL
DAY
Date:05/06/04ISR Number: 4354107-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040404867
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
OROPHARINGEAL
18-Aug-2005
Page: 478
11:49 AM
PT
Report Source
Product
Role
Drug Ineffective
Concerta
PS
Dyskinesia
Medikinet
SS
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Medikinet
Catapresan
SS
C
Date:05/06/04ISR Number: 4354108-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040303304
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
OROPHARINGEAL
PT
Report Source
Chest Pain
Product
Role
Concerta
PS
Manufacturer
Route
Manufacturer
Route
Circulatory Collapse
Dyspnoea
Pain In Extremity
Pallor
Date:05/06/04ISR Number: 4354109-1Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040402217
Age:
Gender:Male
I/FU:F
Outcome
Dose
Duration
Other
OROPHARINGEAL
PT
Report Source
Anorexia
Product
Role
Concerta
PS
Weight Decreased
Date:05/06/04ISR Number: 4354265-5Report Type:Expedited (15-DaCompany Report #PHBS2004CA05701
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
Dyspepsia
Date:05/06/04ISR Number: 4357303-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040500445
Age:38 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Bundle Branch Block Left
Electrocardiogram Qt
Health
Professional
Concreta(Methylpheni
date Hydrochloride)
Duration
Role
Prolonged
Muscle Twitching
Company
Representative
Sustained Release
Tablets
PS
ORAL
SEE IMAGE
Nervousness
Tremor
Date:05/06/04ISR Number: 4357305-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040406592
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Intestinal Obstruction
Consumer
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
Date:05/06/04ISR Number: 4357306-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040406333
Age:11 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 479
Manufacturer
Route
Duration
PT
Blood Pressure Increased
Chest Pain
Dilatation Atrial
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dizziness
Dose
Report Source
Product
Role
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:05/07/04ISR Number: 4356824-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040404867
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Condition Aggravated
Dyskinesia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Medikinet
(Methylphenidate
Hydrochloride)
SS
Catapresan(Clonidine
)
C
Manufacturer
Route
Duration
ORAL
18 MG, IN 1
DAY, ORAL
SEE IMAGE
Date:05/07/04ISR Number: 4356827-8Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040402217
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Anorexia
Weight Decreased
Foreign
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
54 MG, 1 IN 1
ORAL
DAY, ORAL
Date:05/07/04ISR Number: 4356830-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040303304
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Chest Pain
Circulatory Collapse
Dyspnoea
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
54 MG, 1 IN 1
Pain In Extremity
DAY, ORAL
Pallor
Date:05/10/04ISR Number: 4354920-7Report Type:Expedited (15-DaCompany Report #PHEH2004US04863
Age:
Gender:
I/FU:I
Outcome
Dose
Death
18-Aug-2005
Page: 480
PT
Report Source
Product
Role
Manufacturer
Ritalin
PS
Novartis Sector:
Pharma
Duration
Renal Failure
11:49 AM
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/10/04ISR Number: 4354930-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB01949
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Pharma
Route
Duration
Accommodation Disorder
UNKNOWN
Date:05/10/04ISR Number: 4357504-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040406129
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Aggression
Psychotic Disorder
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Manufacturer
Route
Duration
ORAL
54 MG, IN 1
DAY, ORAL
Date:05/11/04ISR Number: 4356663-2Report Type:Direct
Age:5 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 218312
Report Source
Product
Role
Ritalin 10 Mg
PS
Manufacturer
Route
Duration
Drug Effect Decreased
ORAL
1 PO BID
Pharmaceutical Product
Complaint
Date:05/12/04ISR Number: 4357226-5Report Type:Direct
Age:40 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG
PT
Company Report #CTU 218503
Report Source
Product
Role
Concerta 36 Mg
PS
Duration
Heart Rate Increased
Manufacturer
Route
Date:05/12/04ISR Number: 4359306-7Report Type:Expedited (15-DaCompany Report #CEL-2004-0224-ROC
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Other
Required
Intervention to
Prevent Permanent
40MG QAM PO
Impairment/Damage
PT
Report Source
Product
Role
Abnormal Behaviour
Grand Mal Convulsion
Incoherent
Postictal State
Health
Professional
Company
Representative
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Metadate Er Tablets
10mg
(Methylphenidate
Hydrochloride)
SS
Thinking Abnormal
Manufacturer
Route
ORAL
10MG AT 5:00
PM,
Date:05/12/04ISR Number: 4359349-3Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20040500353
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
36 MG, IN 1
DAY; ORAL
18-Aug-2005
Page: 481
PT
Report Source
Product
Role
Depression
Self Injurious Behaviour
Suicidal Ideation
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/12/04ISR Number: 4359472-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040500741
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Cholecystitis Acute
Dehydration
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
ORAL
18 MG, 1 IN 1
DAY, ORAL
Date:05/14/04ISR Number: 4358356-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE04364
Age:6 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
15 mg/day
PT
Report Source
Henoch-Schonlein Purpura
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Route
Ritaline
SS
15 mg/day
Date:05/14/04ISR Number: 4358696-9Report Type:Direct
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 218657
Report Source
Product
Role
Manufacturer
Methylin 5mg
Mallinckrot
PS
Mallinckrot
Duration
Drug Ineffective
Pharmaceutical Product
AURICULAR
(OTIC)
DAILY
AURICULAR (OT
Complaint
5MG ONCE
Psychomotor Hyperactivity
Date:05/14/04ISR Number: 4360267-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040502040
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Aggression
Condition Aggravated
Psychomotor Hyperactivity
Consumer
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:05/14/04ISR Number: 4360268-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040502012
Age:12 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Pressure Increased
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:05/17/04ISR Number: 4358726-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB02013
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Aggression
5-10mg prn
Concerta
54mg/day
18-Aug-2005
Page: 482
11:49 AM
SS
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/17/04ISR Number: 4360344-9Report Type:Expedited (15-DaCompany Report #C03-T-061
Age:18 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Drug Ineffective
Consumer
Methylphenidate
Hydrochloride
Tablets, Usp 20mg
PS
Able Laboratories,
Inc.
Route
Duration
Date:05/18/04ISR Number: 4359423-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040501520
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization OROPHARINGEAL
Initial or Prolonged
Other
PT
Report Source
Hallucinations, Mixed
6
WK
Schizoaffective Disorder
Thinking Abnormal
Product
Role
Concerta
PS
Manufacturer
Route
Manufacturer
Route
Date:05/18/04ISR Number: 4362690-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040405591
Age:21 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Heart Rate Increased
Hypertension
Palpitations
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
ORAL
54 MG, 1 IN 1
DAY, ORAL
Date:05/18/04ISR Number: 4363193-0Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040502767
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Intentional Misuse
Medication Error
Foreign
Health
Concerta
(Methylphenidate
Duration
Role
Manufacturer
Route
Professional
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
54 MG, ORAL
Date:05/18/04ISR Number: 4363194-2Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040406054
Age:16 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Intentional Misuse
Medication Error
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Dexedrine Extended
Release
(Dexamfetamine
Sulfate)
C
54 MG,
INTRA-NASAL
18-Aug-2005
Page: 483
Manufacturer
Route
Duration
11:49 AM
NASAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/18/04ISR Number: 4363198-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040203651
Age:15 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Back Pain
Haematuria
Renal Pain
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
54 MG; 72 MG,
1 IN 1 DAY,
Date:05/19/04ISR Number: 4360127-XReport Type:Expedited (15-DaCompany Report #PT-JNJFOC-20040501746
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
OROPHARINGEAL
PT
Report Source
Diarrhoea
Product
Role
Concerta
PS
Diarrhoea Haemorrhagic
Date:05/19/04ISR Number: 4363892-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040501520
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Hallucinations, Mixed
Schizophrenia
Thinking Abnormal
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
36 MG, 1 IN 1
DAY, ORAL
Date:05/20/04ISR Number: 4361257-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE01767
Age:37 YR
Gender:Male
I/FU:I
ORAL
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
25 mg/day
PT
Report Source
Chest Pain
Troponin I Increased
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Rytmonorm
C
ORAL
Unknown
Date:05/20/04ISR Number: 4361258-0Report Type:Expedited (15-DaCompany Report #PHFR2004GB02075
Age:40 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Methylphenidate
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
Blindness Transient
10 mg, TID
Date:05/20/04ISR Number: 4365919-9Report Type:Expedited (15-DaCompany Report #PT-JNJFOC-20040501746
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18 MG, IN 1
DAY, ORAL
18-Aug-2005
Page: 484
PT
Report Source
Product
Role
Diarrhoea Haemorrhagic
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/21/04ISR Number: 4362495-1Report Type:Expedited (15-DaCompany Report #PHNU2004DE01816
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Electroencephalogram
Abnormal
Fall
Loss Of Consciousness
Syncope
Date:05/21/04ISR Number: 4363857-9Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
PT
Company Report #CTU 219257
Report Source
Product
Role
Metadate Sr 10 Mg
PS
Duration
Abnormal Behaviour
ORAL
ONE PO QD
Distractibility
Pharmaceutical Product
Complaint
Date:05/25/04ISR Number: 4364357-2Report Type:Expedited (15-DaCompany Report #PHNU2004DE01846
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Unknown
PT
Report Source
Product
Role
Manufacturer
Route
Methylphenidate
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
Cerebral Artery Occlusion
Cerebral Infarction
60480MIN
Dysarthria
Facial Paresis
Monoparesis
Vith Nerve Paralysis
Date:05/25/04ISR Number: 4369041-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040104427
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Angina Pectoris
Foreign
Concerta
Duration
Role
Dyspnoea Exertional
Electrocardiogram St
Health
Professional
(Methylphenidate
Hydrochloride)
PS
ORAL
36 MG, IN 1
Segment Elevation
DAY, ORAL
Sinus Tachycardia
Date:05/25/04ISR Number: 4369044-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040302601
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Abnormal Dreams
Anticipatory Anxiety
Hallucination, Visual
Foreign
Health
Professional
Concerta Xl
(Methylphenidate
Hydrochloride)
PS
72 MG, 1 IN 1
Post Procedural
DAY, ORAL
Complication
Skin Laceration
Tendon Injury
Thermal Burn
Vascular Injury
18-Aug-2005
Page: 485
Manufacturer
Route
Duration
11:49 AM
Cefuroxime
(Cefuroxime)
Ondansetron
(Ondansetron)
Paracetamol
(Paracetamol)
Diclofenac
(Diclofenac)
Cyclizine
(Cyclizine)
C
C
C
C
C
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Co-Codamol
(Panadeine Co)
Cefuroxine
(Cefuroxime) Unknown
C
C
Date:05/26/04ISR Number: 4367230-9Report Type:Expedited (15-DaCompany Report #2004-116006-NL
Age:74 YR
Gender:Female
I/FU:I
Outcome
Dose
Death
7.5 MG QD
PT
Report Source
Product
Role
Manufacturer
Route
Asthenia
Health
Remeron Soltab
PS
ORAL
Depressed Level Of
Professional
Consciousness
Remeron Soltab
SS
ORAL
Dysarthria
Remeron Soltab
SS
ORAL
Oedema
Remeron Soltab
SS
ORAL
Renal Failure
Ritalin
SS
ORAL
Ritalin
SS
ORAL
Ritalin
SS
ORAL
Bextra
SS
ORAL
Prevacid
SS
ORAL
Avandia
SS
ORAL
Avandia
SS
ORAL
Duration
ORAL
2
DAY
15 MG QD ORAL
4
DAY
22.5 MG QD
Hepatic Failure
ORAL
3
DAY
30 MG QD ORAL
2.5 MG BID
ORAL
5 MG BID ORAL
7.5 MG BID
ORAL
10 MG QD ORAL
30 MG QD ORAL
4 MG DAILY
ORAL
8 MG DAILY
ORAL
Norvasc
SS
Hydrochlorothiazide
Levaquin
Ativan
Actonel
Dilantin
Wygesic
Altace
Os-Cal
Catapressan
Persantine
Colace
Lexapro
Pepcid
Coumadine
Flonase
Glyburide
C
C
C
C
C
C
C
C
C
C
C
C
C
C
C
C
ORAL
5 MG QD ORAL
Date:05/26/04ISR Number: 4372657-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040504699
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Hypertension
Pulmonary Oedema
Health
Professional
Concerta
(Methylphenidate
(Hydrochloride)
Sustained Release
Tablets
PS
ORAL
Neo-Synephrine
(Phenylephrine
Hydrochloride)
SS
NASAL
ORAL
NASAL
18-Aug-2005
Page: 486
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/27/04ISR Number: 4369418-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040504699
Age:10 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Manufacturer
Route
Hypertension
Pulmonary Oedema
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)Sustai
ned Release Tablets
PS
ORAL
Neo-Synephrine
(Phenylphrine
Hydrochloride)
SS
NASAL
54 MG, 1 IN 1
DY, ORAL
NASAL
Date:05/27/04ISR Number: 4370101-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040503465
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Cholestasis
Hepatitis
Rash Scaly
Urticaria
Foreign
Health
Professional
Concerta(Methylpheni
date
Hydrochloride)Sustai
ned Release Tablets
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:05/28/04ISR Number: 4366761-5Report Type:Expedited (15-DaCompany Report #PHBS2004BR06639
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
1 tablet/d
PT
Report Source
Product
Role
Manufacturer
Route
Ritalina
PS
Novartis Sector:
Pharma
ORAL
Duration
Paralysis
21600MIN
Date:05/28/04ISR Number: 4366764-0Report Type:Expedited (15-DaCompany Report #PHEH2004US05626
Age:8 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Overdose
Date:05/28/04ISR Number: 4367404-7Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization 54 MG QD ORAL
Initial or Prolonged
18-Aug-2005
Page: 487
11:49 AM
Report Source
PT
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Company Report #CTU 219727
Report Source
Product
Role
Atrial Fibrillation
Concerta
PS
Blood Pressure Diastolic
Decreased
Cardiac Failure
Congestive
Cardiomyopathy
Drug Abuser
Ejection Fraction
Decreased
Fall
Heart Rate Increased
Hypomagnesaemia
Hypoxia
Loss Of Consciousness
Metabolic Acidosis
Pulmonary Congestion
Respiratory Acidosis
Ventricular Hypokinesia
Zyrtec
Creatine
C
C
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:05/28/04ISR Number: 4370531-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040504718
Age:
Gender:
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Movement Disorder
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Seroquel (Quetiapine
Fumarate)
C
Manufacturer
Route
ORAL
ORAL
Date:06/01/04ISR Number: 4367303-0Report Type:Expedited (15-DaCompany Report #PHBS2004BR06886
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritalina
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
Asthma
1.5 DF/d
Nasonex
C
Aerolin "Glaxo
Wellcome"
C
Clenil
C
UNK, QD
UNK, QID
UNK, BID
Date:06/01/04ISR Number: 4370915-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040501520
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
36 MG, 1 IN1
DAY, ORAL
PT
Report Source
Product
Role
Hallucination, Auditory
Hallucination, Visual
Paranoia
Thinking Abnormal
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
Dipiperon
(Unspecified)
Pipamperone
C
Date:06/02/04ISR Number: 4372116-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040300993
Age:13 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Anorexia
Weight Decreased
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Ritalin
(Methylphenidate
Hydrochloride)
SS
36 MG, 1 IN 1
DAY, ORAL
10 MG, IN 1
DAY; 15 MG, 2
IN 1 DAY
18-Aug-2005
Page: 488
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/02/04ISR Number: 4372225-5Report Type:Expedited (15-DaCompany Report #MK200405-0425-1
Age:24 YR
Gender:Male
I/FU:I
Outcome
PT
Dose
Duration
Hospitalization Cerebral Infarction
Initial or Prolonged
Lacunar Infarction
60MG, DAILY
6
MON
Report Source
Product
Role
Foreign
Literature
Methylphenidate Hcl
Tabs, Usp 20mg
PS
Date:06/04/04ISR Number: 4371829-3Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Manufacturer
Route
Manufacturer
Route
Company Report #CTU 220139
Report Source
Product
Role
Methylphenidate 10
Mg 00406-1122-10
PS
Duration
Nausea
Pharmaceutical Product
ORAL
1 TAB BID
Complaint
ORAL
Date:06/04/04ISR Number: 4374198-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040506500
Age:16 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Dizziness
Drug Screen Positive
Fall
Head Injury
Nausea
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Lamictal
(Lamotrigine)
C
Manufacturer
Route
Duration
ORAL
ORAL
Syncope
Date:06/08/04ISR Number: 4377851-5Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20040500353
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Depression
Intentional Self-Injury
Foreign
Health
Concerta
(Methylphenidate
Duration
Role
Manufacturer
Route
Suicidal Ideation
Professional
Hydrochloride)
Unspecified
PS
ORAL
36 MG, IN 1
DAY, ORAL
Date:06/10/04ISR Number: 4378820-1Report Type:Expedited (15-DaCompany Report #CEL-2004-01183-SLO
Age:40 YR
Gender:Male
I/FU:I
Outcome
Dose
Disability
PT
Report Source
Product
Role
Blindness Transient
Foreign
Health
Professional
Methylphenidate
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10MG THREE
TIMES DAILY,
ORALLY
Date:06/10/04ISR Number: 4385322-5Report Type:Direct
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #USP 56655
Report Source
Product
Role
Adderall 10 Mg
PS
Methylphenidate 10
Mg
SS
Duration
Medication Error
TABLET
TABLET
18-Aug-2005
Page: 489
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:06/14/04ISR Number: 4379969-XReport Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040601564
Age:46 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Condition Aggravated
Drug Level Below
Therapeutic
Grand Mal Convulsion
Foreign
Health
Professional
Company
Concerta
(Methylphenidate
Hydrochloride)
Sustained
PS
Oral Intake Reduced
Representative
Manufacturer
Route
Duration
ORAL
54 MG, 1 IN 1
DAY, ORAL
Petit Mal Epilepsy
Sleep Disorder
Treatment Noncompliance
Divalproex Sodium
(Valproate
Semisodium)
Lamotrigine
(Lamotrigine)
C
C
Date:06/15/04ISR Number: 4381800-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040304599
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Blindness Transient
Colour Blindness
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
54 MG, 1 IN 1
DAY, ORAL
Date:06/15/04ISR Number: 4382204-XReport Type:Expedited (15-DaCompany Report #2004037749
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Gastrointestinal Disorder
Health
Professional
Company
Representative
Zoloft (Sertraline)
Methylphenidate
Hydrochloride
(Methylphenidate
Hydrochloride)
PS
Duration
SS
Manufacturer
Route
Date:06/15/04ISR Number: 4382229-4Report Type:Expedited (15-DaCompany Report #CEL-2004-01190-ROC
Age:24 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Suicidal Ideation
Consumer
Metadate Cd Capsules
10 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
10 MG, TWICE
DAILY, ROUTE
PO
Depo Provera
(Medroxyprogesterone
Acetate)
Effexor (Venlafaxine
Hydrochloride)
C
C
Date:06/16/04ISR Number: 4381215-8Report Type:Expedited (15-DaCompany Report #200412747BCC
Age:10 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Hypertension
Pulmonary Oedema
Health
Professional
Other
Neo-Synephrine
(Phenylephrine
Hydrochloride)
PS
NASAL
Concerta
18-Aug-2005
Page: 490
11:49 AM
Manufacturer
Route
NASAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
(Methylphenidate
Hydrochloride)
SS
ORAL
54 MG, QD,
ORAL
Date:06/17/04ISR Number: 4379409-0Report Type:Expedited (15-DaCompany Report #PHEH2004US06099
Age:56 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
30 mg, QD
PT
Report Source
Dysuria
Pelvic Deformity
Product
Role
Manufacturer
Route
Ritalin La
PS
Novartis Sector:
Pharma
ORAL
Ritalin-Sr
SS
Lexapro
C
ORAL
20 mg, QD
10 mg, UNK
Date:06/17/04ISR Number: 4381209-2Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Life-Threatening
PT
Company Report #CTU 221010
Report Source
Drug Interaction
Hypertension
Product
Concerta
Mcneil
Role
Manufacturer
Route
PS
Mc Neil
SS
Bayer
NASAL
Manufacturer
Route
54 Mg.
54 MG QD X 3
Pulmonary Oedema
YEARS
Neosynephriene 1%
Nasal Spray Bayer
3 NASAL
SPRAYS
Date:06/18/04ISR Number: 4383574-9Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040601564
Age:46 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Anticonvulsant Drug Level
Below Therapeutic
Foreign
Health
Concerta
(Methylphenidate
Duration
Role
Excessive Exercise
Grand Mal Convulsion
Insomnia
Professional
Company
Representative
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
54 MG, 1 IN 1
Medication Error
DAY, ORAL
Petit Mal Epilepsy
Somnolence
Treatment Noncompliance
Divalproex Sodium
(Valproate
Semisodium))
Lamotrigine
(Lamotrigine)
C
C
Date:06/21/04ISR Number: 4383922-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040302004
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Abnormal Behaviour
Aggression
Drug Ineffective
Food Craving
Suicidal Ideation
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
36 MG, IN 1
DAY, ORAL
Date:06/21/04ISR Number: 4397233-XReport Type:Periodic
Age:47 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 491
Company Report #USA-2004-0013440
PT
Report Source
Product
Polysubstance Abuse
Consumer
Other
Oxycontin Tablets
(Oxycodone
Duration
11:49 AM
Role
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Hydrochloride)
Morphine Sulfate
(Similar To Nda
19-516) (Morphine
Sulfate)
Ritalin
(Methylphenidate
Hydrochloride)
Codeine (Codeine)
Date:06/22/04ISR Number: 4383170-3Report Type:Direct
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
PS
SS
SS
SS
Company Report #CTU 221221
Report Source
Product
Role
Hallucination, Auditory
Methylphenidate Er
PS
Insomnia
Irritability
Sleep Talking
Guanfacine
C
Manufacturer
Route
Duration
ORAL
18 MG PO QAM
Date:06/22/04ISR Number: 4385130-5Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20040602728
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Depression
Suicide Attempt
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
36 MG, 1 IN 1
DAY, ORAL
Date:06/23/04ISR Number: 4383185-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB02495
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Pharma
Duration
Cardiac Murmur
Route
Date:06/23/04ISR Number: 4386271-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040603060
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Medication Error
Overdose
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
54 MG, 1 IN 1
DAY, ORAL
Date:06/24/04ISR Number: 4388674-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040603003
Age:
Gender:Unknown
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Blood Pressure Increased
Heart Rate Increased
Nasal Congestion
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
Phenylephrine
Hydrochloride Nasal
18-Aug-2005
Page: 492
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Spray (Phenylephrine
Hydrochloride) Spray
SS
NASAL
NASAL
Date:06/24/04ISR Number: 4388686-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040603068
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Disease Recurrence
Herpes Ophthalmic
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Manufacturer
Route
Duration
Date:06/28/04ISR Number: 4385340-7Report Type:Expedited (15-DaCompany Report #PHBS2004JP08068
Age:36 YR
Gender:Male
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Duration
Death
Drug Withdrawal Syndrome
1095 DAY
Joint Stiffness
Date:06/28/04ISR Number: 4385839-3Report Type:Expedited (15-DaCompany Report #PHBS2004NL08230
Age:42 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
Abortion Spontaneous
Depression
Dry Mouth
Date:06/28/04ISR Number: 4386816-9Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
18 MGS TWICE
PT
Abnormal Behaviour
Company Report #CTU 221695
Report Source
Product
Role
Concerta 18 Mgs
PS
ORAL
Confusional State
DAIL ORAL
Memory Impairment
Zoloft
C
Date:06/28/04ISR Number: 4389486-9Report Type:Expedited (15-DaCompany Report #DK-JNJFOC-20040304590
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Blood Pressure Increased
Henoch-Schonlein Purpura
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
36 MG, IN 1
DAY, ORAL
Date:06/29/04ISR Number: 4388089-XReport Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Hospitalization Initial or Prolonged
18-Aug-2005
Page: 493
11:49 AM
PT
Abnormal Behaviour
Affective Disorder
Bipolar Disorder
Intentional Self-Injury
Social Avoidant Behaviour
Company Report #CTU 221758
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Suicide Attempt
Report Source
Dose
Product
Role
Manufacturer
Route
Concerta 36 Mg.
PS
ORAL
Zoloft 25 Mg
SS
ORAL
Duration
36 MG ORAL
25 MG ORAL
Date:06/30/04ISR Number: 4389476-6Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20040604900
Age:18 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Chest Pain
Foreign
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:06/30/04ISR Number: 4415346-0Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Company Report #2003021340
PT
Report Source
Product
Role
Agitation
Convulsion
Consumer
Zoloft (Sertraline)
Methylphenidate
Hydrochloride
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Duration
Date:06/30/04ISR Number: 4415719-6Report Type:Periodic
Age:11 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
SS
Company Report #2004014632
PT
Report Source
Product
Role
Aggression
Depression
Suicidal Ideation
Consumer
Zoloft (Sertraline)
Methylphenidate
Hydrochloride
(Methylphenidate
Hydrochloride)
PS
SS
Date:07/01/04ISR Number: 4391901-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040605147
Age:6 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Hallucination, Visual
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:07/01/04ISR Number: 4393566-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040604066
Age:15 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Eye Movement Disorder
Foreign
Health
Professional
Risperdal
(Risperidone)
Unspecified
PS
Topiramate
(Topiramate)
SS
Duration
1 MG, 1 IN 1
DAY
50 MG, 2 IN 1
DAY
18-Aug-2005
Page: 494
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Concerta Xl
(Methylphenidate
Hydrochloride)
SS
54 MG
Date:07/02/04ISR Number: 4389456-0Report Type:Expedited (15-DaCompany Report #PHNU2004DE02303
Age:
Gender:Female
I/FU:I
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Death
Poisoning Deliberate
Unknown
Asa
C
ORAL
Furosemide
C
ORAL
Haldol "Janssen"
C
ORAL
Digitoxin
C
ORAL
Unknown
Unknown
Unknown
Unknown
Date:07/02/04ISR Number: 4389475-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB02075
Age:40 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Blindness Transient
Health
Professional
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
10 mg, TID
Date:07/02/04ISR Number: 4392542-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040406592
Age:44 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Gastrointestinal
Obstruction
Gastrointestinal
Perforation
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Role
Tablets
PS
ORAL
54 MG, 1 IN 1
DAY, ORAL
Date:07/02/04ISR Number: 4392604-XReport Type:Expedited (15-DaCompany Report #HQWYE647924JUN04
Age:36 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Enuresis
Feeling Abnormal
Formication
Foreign
Consumer
Other
Efexor
(Venlafaxine
Hydrochloride)
PS
Ritalin
(Methylphenidate
Hydrochloride)
Ativan (Lorazepam)
SS
C
Manufacturer
Route
ORAL
150 MG 1X PER
General Physical Health
1 DAY ORAL
Deterioration
Insomnia
Weight Decreased
Date:07/02/04ISR Number: 4392692-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040606160
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Tachycardia
Foreign
Health
Risperdal
(Risperidone)
PS
3 MG, IN 1
Professional
DAY, ORAL
Concerta
(Methylphenidate
Hydrochloride)
18-Aug-2005
Page: 495
Manufacturer
Route
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Sustained Release
Tablets
SS
ORAL
SEE IMAGE
Date:07/02/04ISR Number: 4392698-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040605857
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Diplopia
Strabismus
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
ORAL
18 MG, IN 1
DAY, ORAL
Date:07/07/04ISR Number: 4394262-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040405591
Age:21 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Hypertension
Palpitations
Consumer
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Released
Tablets
PS
Manufacturer
Route
Duration
ORAL
54 MG, 1 IN 1
DAY, ORAL
Date:07/07/04ISR Number: 4394264-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040406333
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Blood Pressure Increased
Chest Pain
Dilatation Atrial
Dizziness
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Duration
Role
Manufacturer
Route
Heart Rate Increased
Tablets
PS
ORAL
SEE IMAGE
Date:07/07/04ISR Number: 4395758-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040603068
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
UNKNOWN
PT
Report Source
Product
Role
Disease Recurrence
Eye Infection
Herpes Virus Infection
Foreign
Health
Professional
Concentra
(Methylphenidate
Hydrochloride)
Unspecified
PS
Manufacturer
Route
Manufacturer
Route
Duration
54 MG, 1 IN 1
DAY; UNKNOWN
Date:07/07/04ISR Number: 4395761-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040606829
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Delusion
Extrapyramidal Disorder
Hallucination, Auditory
Foreign
Health
Professional
Concentra Xl
(Methylphenidate
Hydrochloride)
PS
Melatonin (Unknown)
Melatonin
C
54MG IN 1
Hypothermia
DAY; ORAL
Medication Error
Photosensitivity Reaction
18-Aug-2005
Page: 496
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/07/04ISR Number: 4395764-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040608216
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
UNKNOWN
PT
Report Source
Product
Role
Social Avoidant Behaviour
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
UNKNOWN
Date:07/08/04ISR Number: 4392046-7Report Type:Expedited (15-DaCompany Report #PHBS2004JP08725
Age:52 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Aggression
Gait Disturbance
Parkinson'S Disease
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Date:07/08/04ISR Number: 4393027-XReport Type:Expedited (15-DaCompany Report #DK-GLAXOSMITHKLINE-B0337688A
Age:9 YR
Gender:Male
I/FU:F
Outcome
PT
Dose
Duration
Hospitalization Acute Psychosis
RESPIRATORY
Initial or Prolonged
Agitation
(INHALATION)
2PUFF Twice
Anxiety
per day
Confusional State
5MG Three
Drug Interaction
times per day 2
DAY
Hyperhidrosis
Hyperventilation
Social Avoidant Behaviour
Tremor
Date:07/08/04ISR Number: 4394099-9Report Type:Direct
Age:
Gender:Male
I/FU:I
Report Source
Product
Role
Manufacturer
Seretide
PS
Glaxosmithkline
Methylphenidate
SS
Company Report #CTU 222406
Route
ORAL
Outcome
Dose
Duration
Disability
Required
1 DAY
Intervention to
Prevent Permanent
Impairment/Damage
PT
Tic
Vocal Cord Disorder
Date:07/08/04ISR Number: 4394140-3Report Type:Direct
Age:41 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
Report Source
PT
Product
Role
Manufacturer
Methylphenidate 10
Mg Novartis
PS
Novartis
Product
Role
Manufacturer
Route
Methylphenidate
10mg
PS
Manufacturer
Route
Route
Company Report #CTU 222435
Report Source
Duration
Insomnia
Migraine
Date:07/08/04ISR Number: 4395831-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040206433
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
18 MG, 1 IN 1
DAY, ORAL
18-Aug-2005
Page: 497
11:49 AM
PT
Report Source
Product
Role
Near Drowning
Suicide Attempt
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustaines Release
Tablet
PS
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/09/04ISR Number: 4396478-2Report Type:Expedited (15-DaCompany Report #PT-JNJFOC-20040607708
Age:8 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Electrooculogram Abnormal
Maculopathy
Retinal Disorder
Retinopathy
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
18 MG, ORAL
Date:07/12/04ISR Number: 4394728-XReport Type:Expedited (15-DaCompany Report #PHBS2004JP08725
Age:52 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Manufacturer
Aggression
Drug Dependence
Gait Disturbance
Parkinson'S Disease
Health
Professional
Ritalin
PS
Ritalin
SS
Novartis Sector:
Pharma
Novartis Sector:
Pharma
Route
ORAL
ORAL
50 DF, QD
Tremor
Date:07/14/04ISR Number: 4400039-6Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20040604900
Age:16 YR
Gender:Male
I/FU:F
Outcome
Dose
Disability
Other
PT
Report Source
Product
Role
Chest Pain
Cold Sweat
Dyspnoea
Foreign
Health
Professional
Concerta
(Methyphenidate
Hydrochloride)
PS
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
Vomiting
DAY, ORAL
Date:07/14/04ISR Number: 4400046-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040605857
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Hospitalization Initial or Prolonged
Diplopia
Strabismus
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
18 MG, IN 1
DAY, ORAL
Date:07/14/04ISR Number: 4400049-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040700659
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Diabetes Mellitus
Insulin-Dependent
Foreign
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
36 MG, IN 1
DAY,ORAL
Date:07/14/04ISR Number: 4400052-9Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20040604519
Age:12 YR
Gender:Male
I/FU:I
Outcome
Other
18-Aug-2005
Page: 498
Manufacturer
Route
Duration
PT
Drug Interaction
Gynaecomastia
11:49 AM
Report Source
Foreign
Health
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Professional
Dose
Product
Role
Manufacturer
Route
Risperdal
(Risperidone)
PS
ORAL
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
SS
ORAL
Duration
0.5 MG, ORAL
54 MG, ORAL
Date:07/15/04ISR Number: 4398924-7Report Type:Expedited (15-DaCompany Report #PHBS2003JP13732
Age:
Gender:Male
I/FU:F
Outcome
Dose
Duration
Life-Threatening
Hospitalization TRANSPLACENTAL
Initial or Prolonged
TRANSPLACENTAL
PT
Report Source
Product
Role
Manufacturer
Apnoea
Cyanosis
Ritalin
PS
Novartis Sector:
Pharma
Drug Exposure During
Paxil
SS
Pregnancy
Rohypnol
SS
Irritability
Solanax
SS
Route
TRANSPLACENTAL
TRANSPLACENTAL
Tremor
Date:07/15/04ISR Number: 4398925-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE02413
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Hypothyroidism
Date:07/15/04ISR Number: 4398926-0Report Type:Expedited (15-DaCompany Report #PHNU2004DE02414
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Hypothyroidism
Date:07/15/04ISR Number: 4398928-4Report Type:Expedited (15-DaCompany Report #PHNU2004DE02412
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
Hypothyroidism
Date:07/19/04ISR Number: 4403904-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040701677
Age:18 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Life-Threatening
ORAL
18-Aug-2005
Page: 499
11:49 AM
PT
Report Source
Product
Role
Injury Asphyxiation
Suicide Attempt
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/20/04ISR Number: 4402017-XReport Type:Expedited (15-DaCompany Report #PHFR2003GB01311
Age:14 YR
Gender:Male
I/FU:F
Outcome
Dose
Disability
PT
Report Source
Product
Role
Manufacturer
Route
Cyanosis
Echocardiogram Abnormal
Ritalin-Sr
PS
Novartis Sector:
Pharma
ORAL
Livedo Reticularis
Pain In Extremity
Ritalin-Sr
SS
Peripheral Coldness
Lactulose
C
Duration
20mg/day
40mg/day
20160MIN
Novartis Sector:
Pharma
10080MIN
ORAL
10-20ml/BID/P
Poor Peripheral
RN
Circulation
Raynaud'S Phenomenon
Skin Discolouration
Tachycardia
Ventricular Septal Defect
Ventricular Septal Defect
Acquired
Date:07/20/04ISR Number: 4402018-1Report Type:Expedited (15-DaCompany Report #PHBS2004JP08725
Age:52 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
Other
PT
Report Source
Product
Role
Manufacturer
Aggression
Drug Dependence
Gait Disturbance
Parkinson'S Disease
Health
Professional
Ritalin
PS
Ritalin
SS
Novartis Sector:
Pharma
Novartis Sector:
Pharma
Route
ORAL
ORAL
50 DF, QD
Tremor
Date:07/20/04ISR Number: 4404445-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040405349
Age:15 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Abnormal Behaviour
Aggression
Alcohol Poisoning
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Role
Manufacturer
Route
Apathy
Depression
Sustained Release
Tablets
PS
ORAL
Impulse-Control Disorder
Weight Increased
Lexapro
(Escitalopram
Oxalate) (All Other
Therapeutic
Products)
SS
ORAL
SEE IMAGE
SEE IMAGE
Date:07/20/04ISR Number: 4404706-XReport Type:Expedited (15-DaCompany Report #CEL-2004-00320-ROC(1)
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Other
Required
Intervention to
Prevent Permanent
SEE IMAGE
Impairment/Damage
18-Aug-2005
Page: 500
11:49 AM
PT
Report Source
Product
Role
Grand Mal Convulsion
Health
Professional
Metadate Cd Capsules
20 Mg
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/20/04ISR Number: 4404757-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040608216
Age:8 YR
Gender:Male
I/FU:F
Outcome
Dose
Disability
PT
Report Source
Product
Role
Anxiety
Fear
Listless
Merycism
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Manufacturer
Route
Duration
ORAL
18 MG, 1 IN 1
Psychiatric Symptom
DAY, ORAL
Social Avoidant Behaviour
Date:07/22/04ISR Number: 4408175-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040702344
Age:21 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Haematuria
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Route
Duration
54 MG
Date:07/22/04ISR Number: 4408205-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040704183
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Haematuria
Vasculitis Necrotising
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
PS
Duration
54 MG
Date:07/23/04ISR Number: 4405149-5Report Type:Expedited (15-DaCompany Report #PHNU2004DE01468
Age:11 YR
Gender:Female
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Duration
Aplastic Anaemia
Biopsy Bone Marrow
15mg/day
71
Pharma
ORAL
DAY
Abnormal
Haematocrit Decreased
Haemoglobin Decreased
Mean Cell Haemoglobin
Mean Cell Volume Abnormal
Pancytopenia
Platelet Count Decreased
Red Blood Cell Count
Decreased
Reticulocyte Percentage
Decreased
White Blood Cell Count
Decreased
Date:07/23/04ISR Number: 4405225-7Report Type:Expedited (15-DaCompany Report #PHNU2004DE02414
Age:
Gender:Male
I/FU:F
Outcome
Dose
Other
18-Aug-2005
Page: 501
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Blood Thyroid Stimulating
Hormone Increased
Hypothyroidism
Laboratory Test
Interference
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/23/04ISR Number: 4405226-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE02412
Age:
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
Blood Thyroid Stimulating
Hormone Increased
Hypothyroidism
Date:07/23/04ISR Number: 4408574-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040702720
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Cardiac Disorder
Exercise Tolerance
Decreased
Heart Rate Increased
Foreign
Consumer
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
ORAL
18 MG, IN 1
DAY, ORAL
Date:07/23/04ISR Number: 4408591-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040704248
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
C-Reactive Protein
Increased
Leukopenia
Lymphopenia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
ORAL
ORAL
Date:07/26/04ISR Number: 4408372-9Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
PT
Duration
Company Report #CTU 223564
Report Source
Product
Role
Manufacturer
Route
Disability
18MG QAM
Unevaluable Event
Concerta
PS
Date:07/27/04ISR Number: 4411206-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040704267
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Headache
Pyrexia
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Manufacturer
Route
18 MG, IN 1
DAY
Date:07/28/04ISR Number: 4413987-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040201665
Age:11 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
54 MG, ORAL
18-Aug-2005
Page: 502
PT
Report Source
Product
Role
Anorexia
Gynaecomastia
Insomnia
Weight Decreased
Foreign
Health
Professional
Concerta Xl
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:07/28/04ISR Number: 4440673-0Report Type:Periodic
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Company Report #USA040259420
PT
Report Source
Product
Role
Anger
Anorexia
Fatigue
Consumer
Strattera
(Atomoxetine
Hydrochloride)
PS
Concerta(Methylpheni
date Hydrochloride)
Vitamins
SS
C
Manufacturer
Route
Duration
40 MG DAY
Personality Change
Sleep Disorder
Somnolence
Date:07/29/04ISR Number: 4411155-7Report Type:Expedited (15-DaCompany Report #PHBS2004JP08871
Age:7 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
Blood Creatine
Phosphokinase Increased
1 mg/d
Date:07/29/04ISR Number: 4414277-XReport Type:Expedited (15-DaCompany Report #CEL-2004-01474-SLO
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
Required
Intervention to
5 MG TWICE
Prevent Permanent
DAILY, PER
Impairment/Damage
ORAL
PT
Report Source
Product
Role
Drug Ineffective
Foreign
Health
Professional
Equasym 5mg
(Methylphenidate
Hydrochloride)
PS
ORAL
Date:07/29/04ISR Number: 4414598-0Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040402217
Age:12 YR
Gender:Male
I/FU:F
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Other
Anorexia
Weight Decreased
Weight Increased
Foreign
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
ORAL
54 MG, 1 IN 1
DAY, ORAL
Date:07/29/04ISR Number: 4414939-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040704979
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Choreoathetosis
Euphoric Mood
Insomnia
Health
Professional
Company
Representative
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
ORAL
36 MG, 1 IN 1
DAY, ORAL
Date:07/29/04ISR Number: 4443825-9Report Type:Periodic
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
2 MG, 2 IN 1
18-Aug-2005
Page: 503
11:49 AM
Company Report #US-JNJFOC-20040400832
PT
Report Source
Product
Role
Convulsion
Consumer
Risperdal
(Risperidone)
Tablets
PS
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
DAY, ORAL
Concerta
(Methylphenidate
Hydrochloride)
Unspecified
SS
Date:07/30/04ISR Number: 4411684-6Report Type:Expedited (15-DaCompany Report #PHBS2004JP10015
Age:70 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Delirium
Dizziness
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Tremor
Vomiting
Morphine
Hydrochloride
Manufacturer
Route
Duration
20 mg/d
C
Date:07/30/04ISR Number: 4418089-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040503465
Age:9 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
C-Reactive Protein
Increased
Cholestasis
Hepatitis
Rash Scaly
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Duration
ORAL
36 MG, IN 1
DAY, ORAL
Date:08/02/04ISR Number: 4413817-4Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
5 MG
PT
Company Report #CTU 224076
Report Source
Product
Role
Methylphenidate
PS
Duration
Drug Ineffective
Manufacturer
Route
Date:08/03/04ISR Number: 4414271-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB02985
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
UNKNOWN
PT
Report Source
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Pharma
Route
Duration
Asthma
5 mg, BID
Date:08/03/04ISR Number: 4416161-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040605147
Age:6 YR
Gender:
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Drug Effect Decreased
Hallucination, Visual
Screaming
Treatment Noncompliance
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
SEE IMAGE
Date:08/03/04ISR Number: 4416170-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040705611
Age:
Gender:Female
I/FU:I
Outcome
Other
18-Aug-2005
Page: 504
Manufacturer
Route
Duration
PT
Anaphylactic Reaction
11:49 AM
Report Source
Health
Professional
Company
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Representative
Dose
Product
Role
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Other Unspecified
Medications (All
Other Therapeutic
Product)
C
Manufacturer
Route
Duration
ORAL
SEE IMAGE
Date:08/04/04ISR Number: 4421560-0Report Type:Expedited (15-DaCompany Report #CEL-2004-01480-ROC
Age:6 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
Required
Intervention to
10MG
Prevent Permanent
INCREASED TO
Impairment/Damage
20MG DAILY,
PT
Report Source
Product
Role
Headache
Optic Atrophy
Optic Nerve Injury
Health
Professional
Metadate Cd
(Methylphenidate
Hydrochloride)
PS
Strattera
C
Manufacturer
Route
ORAL
ROUTE PO
Date:08/04/04ISR Number: 4422858-2Report Type:Expedited (15-DaCompany Report #S04-USA-04485-01
Age:15 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
10 MG QD PO
Other
15 MG QD PO
PT
Report Source
Product
Role
Abnormal Behaviour
Alcoholism
Health
Professional
Lexapro
(Escitalopram)
PS
ORAL
Lexapro
(Escitalopram)
SS
ORAL
Apathy
Belligerence
Manufacturer
Route
Depression
Disinhibition
Legal Problem
Concerta
(Methylphenidate
Hydrochloride)
SS
Personality Change
Physical Assault
School Refusal
Thinking Abnormal
Weight Increased
Alcohol (Alcohol)
SS
135 MG QD
Date:08/05/04ISR Number: 4418124-1Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Company Report #CTU 224292
Report Source
Product
Role
Generic Ritalin Sr
20 Mg
PS
Disturbance In Attention
Feeling Abnormal
TID PO
Psychomotor Hyperactivity
Stress
Date:08/06/04ISR Number: 4417181-6Report Type:Expedited (15-DaCompany Report #PHBS2004JP10015
Age:70 YR
Gender:Female
I/FU:F
Outcome
Other
18-Aug-2005
Page: 505
Manufacturer
Route
Duration
PT
Delirium
Dizziness
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Drug Toxicity
Tremor
Vomiting
Dose
Report Source
Product
Role
Manufacturer
Route
Health
Professional
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Role
Manufacturer
Route
PS
Eli Lilly
ORAL
Duration
10 mg/d
21600MIN
Ritalin
20 mg/d
SS
4320 MIN
Morphine
Hydrochloride
Durotep Janssen
Date:08/06/04ISR Number: 4424339-9Report Type:Direct
Age:16 YR
Gender:Female
I/FU:I
Outcome
Dose
Disability
80 MGS
PT
C
C
Company Report #CTU 2244425E
Report Source
Product
Duration
Visual Acuity Reduced
Strattera
Eli Lilly
80 Mgs
DAILY
ORAL
Concerta
Date:08/09/04ISR Number: 4420654-3Report Type:Periodic
Age:13 YR
Gender:Male
I/FU:F
Outcome
Dose
PT
SS
Company Report #US-GLAXOSMITHKLINE-A0507436A
Report Source
Product
Role
Manufacturer
Paxil
PS
Glaxosmithkline
Ritalin
SS
Route
Duration
Hallucination
2
YR
Mood Swings
UNKNOWN
UNKNOWN
Date:08/09/04ISR Number: 4421006-2Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0333314A
Age:66 YR
Gender:Female
I/FU:F
Outcome
Dose
PT
Duration
Report Source
Product
Role
Manufacturer
Route
Life-Threatening
10MG Twice
Blood Pressure Decreased
Health
Paxil
PS
Coagulopathy
Professional
Glaxosmithkline
ORAL
Ritalin
SS
ORAL
Consciousness
Tetramide
SS
ORAL
Disseminated
Amoxan
SS
ORAL
Empyema
Depas
SS
ORAL
Glossoptosis
Rohypnol
SS
ORAL
Hyperpyrexia
Sepazon
SS
ORAL
per day
Cyanosis
3U Three
Depressed Level Of
times per day
30MG Per day
25MG Three
Intravascular Coagulation
times per day
1MG Per day
2MG Per day
2MG Three
Infection
times per day
Multi-Organ Failure
Myoclonus
Myoglobinuria
Neuroleptic Malignant
Syndrome
Respiratory Failure
Serotonin Syndrome
Shock
Somnolence
18-Aug-2005
Page: 506
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:08/09/04ISR Number: 4424814-7Report Type:Expedited (15-DaCompany Report #PT-JNJFOC-20040801064
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Depression
Suicidal Ideation
Foreign
Health
Professional
Concerta
(Methylphenidate
Hydrochloride)
Sustained Release
Tablets
PS
Manufacturer
Route
Duration
ORAL
ORAL
Date:08/12/04ISR Number: 4424399-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040603102
Age:
Gender:Male
I/FU:I
Outcome
PT
Dose
Duration
Other
Arthritis
OROPHARINGEAL
0.125mg in
Serum Sickness
am/0.25mg at
HS
3
Report Source
Product
Role
Risperdal
PS
Risperdal
SS
Concerta
Clonidine
Clonidine
Zyrtec
SS
C
C
C
Pepcid
Nasonex
C
C
Flovent
C
MON
OROPHARINGEAL
3
OROPHARINGEAL
27
MON
DAY
RESPIRATORY
(INHALATION)
50mcg
RESPIRATORY
(INHALATION)
needed
2 puffs as
27
DAY
27
DAY
Manufacturer
Route
Date:08/13/04ISR Number: 4427903-6Report Type:Expedited (15-DaCompany Report #CEL-2004-01190-ROC
Age:24 YR
Gender:Female
I/FU:F
Outcome
Dose
Duration
Other
Required
Intervention to
Prevent Permanent
10 MG, TWICE
Impairment/Damage
DAILY, ROUTE
PT
Report Source
Product
Role
Suicidal Ideation
Consumer
Health
Professional
Metadate Cd Capsules
10 Mg
(Methylphenidate
Hydrochloride)
PS
PO
Depo Provera
(Medroxyprogesterone
Acetate)
Effexor (Venlafaxine
Hydrochloride)
Date:08/13/04ISR Number: 4428093-6Report Type:Expedited (15-DaCompany Report #2004052733
Age:47 YR
Gender:Female
I/FU:I
Outcome
Hospitalization Initial or Prolonged
Other
18-Aug-2005
Page: 507
11:49 AM
PT
Abnormal Behaviour
Agitation
Anger
Feeling Abnormal
Homicidal Ideation
Insomnia
Marital Problem
Paranoia
Relationship Breakdown
Thinking Abnormal
C
C
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Treatment Noncompliance
Victim Of Spousal Abuse
Dose
Report Source
Product
Role
Consumer
Neurontin
(Gabapentin)
PS
Manufacturer
Route
Duration
ORAL
ORAL
Methylphenidate
Hydrochloride
All Other
Therapeutic Products
SS
SS
Date:08/16/04ISR Number: 4426843-6Report Type:Expedited (15-DaCompany Report #PHBS2004CA10581
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Blood Thyroid Stimulating
Hormone Increased
Tri-Iodothyronine
Increased
Date:08/19/04ISR Number: 4430593-XReport Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Report Source
Product
Role
Manufacturer
Route
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Manufacturer
Route
Duration
PT
Company Report #CTU 225264
Report Source
Product
Role
Methylphenidate
PS
Duration
Pharmaceutical Product
20 MG - ONCE
Complaint
1/2 AT 4PM
Date:08/23/04ISR Number: 4431211-7Report Type:Direct
Age:33 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
DAILY
DAILY
PT
Company Report #CTU 225422
Report Source
Product
Role
Duration
Agitation
Zoloft
50
Attention
Concerta
PS
36
SS
Deficit/Hyperactivity
Disorder
Emotional Disorder
Euphoric Mood
Feeling Abnormal
Impulse-Control Disorder
Insomnia
Libido Increased
Mood Swings
Palpitations
Paraphilia
Parent-Child Problem
Relationship Breakdown
Somnolence
Suicidal Ideation
Date:08/24/04ISR Number: 4431099-4Report Type:Expedited (15-DaCompany Report #PHBS2004JP10015
Age:75 YR
Gender:Female
I/FU:F
Outcome
Other
18-Aug-2005
Page: 508
PT
Delirium
Depressed Level Of
Consciousness
Dizziness
Malaise
11:49 AM
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Dose
Oxygen Saturation
Decreased
Somnolence
Report Source
Product
Role
Manufacturer
Route
Speech Disorder
Tremor
Health
Professional
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Duration
10 mg/d
Vomiting
20 mg/d
Ritalin
SS
5760 MIN
Morphine
Hydrochloride
Durotep
C
C
Diovan
C
ORAL
Protecadin
Loxonin
Ganaton
C
C
C
ORAL
Rize
C
ORAL
Novamin
C
ORAL
25 mg/d
80 mg/d
150 mg/d
15 mg/d
15 mg/d
Date:08/24/04ISR Number: 4431336-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040702721
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization OROPHARINGEAL
Initial or Prolonged
OROPHARINGEAL
Other
PT
Product
Role
Haematocrit Decreased
Concerta
PS
Haemoglobin Decreased
Medikinet
C
Infectious Mononucleosis
Lymphocyte Percentage
Decreased
Mean Cell Haemoglobin
Concentration Decreased
Monocyte Percentage
Decreased
Neutrophil Percentage
Decreased
White Blood Cell Count
Decreased
Report Source
Manufacturer
Route
Date:08/25/04ISR Number: 4431725-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040504699
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization OROPHARINGEAL
Initial or Prolonged
PT
Report Source
Product
Role
Drug Interaction
Concerta
PS
Malignant Hypertension
Pulmonary Oedema
Tooth Extraction
Neo-Synephrine
SS
Manufacturer
Route
NASAL
Date:08/25/04ISR Number: 4432286-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040702344
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
OROPHARINGEAL
PT
Haematuria
Report Source
Product
Role
Concerta
PS
Manufacturer
Haemorrhage Urinary Tract
Date:08/25/04ISR Number: 4432393-3Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0333314A
Age:66 YR
Gender:Female
I/FU:F
Outcome
Life-Threatening
18-Aug-2005
Page: 509
11:49 AM
PT
Blood Pressure Decreased
Coagulopathy
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Cyanosis
Depressed Level Of
Consciousness
Dose
Report Source
Product
Role
Manufacturer
Route
Paxil
PS
Glaxosmithkline
ORAL
Ritalin
SS
ORAL
Hyperpyrexia
Tetramide
SS
ORAL
Infection
Amoxan
SS
ORAL
Myoclonus
Depas
SS
ORAL
Myoglobinuria
Rohypnol
SS
ORAL
Neuroleptic Malignant
Sepazon
SS
ORAL
Duration
Disseminated
10MG Twice
Intravascular Coagulation
per day
Empyema
3U Three
Glossoptosis
times per day
30MG Per day
25MG Three
Multi-Organ Failure
times per day
1MG Per day
2MG Per day
2MG Three
Syndrome
times per day
Respiratory Failure
Serotonin Syndrome
Shock
Somnolence
Date:08/25/04ISR Number: 4432533-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE02413
Age:10 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Blood Thyroid Stimulating
Hormone Increased
15 mg/day
Hypothyroidism
Date:08/25/04ISR Number: 4432679-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040702344
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
OROPHARINGEAL
PT
Report Source
Haematuria
Product
Role
Concerta
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Date:08/26/04ISR Number: 4433285-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040702720
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
OROPHARINGEAL
PT
Report Source
Heart Rate Increased
Date:08/26/04ISR Number: 4454690-8Report Type:Periodic
Age:69 YR
Gender:Female
I/FU:I
Outcome
Dose
Product
Role
Concerta
PS
Company Report #WAES 0406USA02224
PT
Report Source
Product
Role
Disturbance In Attention
Consumer
Tab Zetia 10 Mg
PS
ORAL
Drug Interaction
Health
Psychomotor Hyperactivity
Professional
Tab Ritalin 40 Mg
SS
ORAL
Celebrex
Zoloft
C
C
Duration
10
MG/DAILY/PO
40
MG/DAILY/PO
Date:08/27/04ISR Number: 4436699-3Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Other
18-Aug-2005
Page: 510
PT
Pharmaceutical Product
Complaint
11:49 AM
Company Report #CTU 225815
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Somnolence
Report Source
Dose
Product
Role
Ritalin Generic
(Methylin)
PS
Manufacturer
Route
Manufacturer
Route
Route
Duration
5 MG DLY
Date:08/31/04ISR Number: 4437824-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040806637
Age:15 YR
Gender:Female
I/FU:I
Outcome
Dose
Duration
Other
OROPHARINGEAL
PT
Report Source
Phobia
Product
Role
Concerta
PS
Concerta
SS
OROPHARINGEAL
Date:08/31/04ISR Number: 4438436-5Report Type:Expedited (15-DaCompany Report #PHBS2004NO11152
Age:
Gender:
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Asthenia
Muscle Fatigue
Health
Professional
Ritalina
PS
Novartis Sector:
Pharma
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
UNKNOWN
Weight Decreased
Date:08/31/04ISR Number: 4438437-7Report Type:Expedited (15-DaCompany Report #PHNU2004DE03040
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Duration
Blood Creatine
Phosphokinase Abnormal
5 to 10mg/day
Date:08/31/04ISR Number: 4439194-0Report Type:Expedited (15-DaCompany Report #CEL-2004-01604-ROC
Age:17 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
Required
Intervention to
Prevent Permanent
Impairment/Damage
PT
Report Source
Product
Role
Blindness
Maculopathy
Retinal Disorder
Health
Professional
Metadate Cd Capsules
(Methylphenidate
Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Date:09/02/04ISR Number: 4440298-7Report Type:Expedited (15-DaCompany Report #C04-T-137
Age:23 YR
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Dizziness
Consumer
Methylphenidate Hcl
Tablets, Usp 10 Mg
PS
Duration
Date:09/02/04ISR Number: 4441083-2Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Required
5 MG BID ORAL
Intervention to
Prevent Permanent
Impairment/Damage
18-Aug-2005
Page: 511
11:49 AM
PT
Abdominal Pain
Cholelithiasis
Company Report #CTU 226183
Report Source
Product
Role
Ritalin 5 Mg
PS
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/02/04ISR Number: 4441084-4Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Required
5-20 MG DAILY
Intervention to
ORAL
Prevent Permanent
36MG DAILY
Impairment/Damage
ORAL
PT
Company Report #CTU 226184
Report Source
Abdominal Pain
Role
Manufacturer
Route
Ritalin
PS
ORAL
Concerta
SS
ORAL
Cholelithiasis
Date:09/03/04ISR Number: 4601412-3Report Type:Periodic
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
Product
Company Report #PHEH2004US03872
PT
Report Source
Product
Role
Convulsion
Consumer
Ritalin(Methylphenid
ate Hydrochloride)
PS
Manufacturer
Route
Manufacturer
Route
Route
Duration
Date:09/07/04ISR Number: 4441616-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040704248
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization OROPHARINGEAL
Initial or Prolonged
OROPHARINGEAL
Other
OROPHARINGEAL
PT
Report Source
Product
Role
C-Reactive Protein
Health
Concerta
PS
Increased
Professional
Concerta
SS
Concerta
SS
Granulocytopenia
Lymphopenia
Date:09/07/04ISR Number: 4441712-3Report Type:Expedited (15-DaCompany Report #PHNU2004DE03099
Age:25 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Duration
Hyperthyroidism
Sleep Disorder
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Unknown
Ritaline
SS
Unknown
Ritalin-Sr
SS
ORAL
1 tab/day
Date:09/07/04ISR Number: 4441750-0Report Type:Expedited (15-DaCompany Report #PHNU2004DE03086
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
Hyperthyroidism
50 to 60
mg/day
Date:09/07/04ISR Number: 4442906-3Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 226386
Report Source
Product
Role
Ritalin Brand Name
Med Necessary
PS
Xanax Brand Name Med
Necessary
SS
Duration
Drug Ineffective
Pharmaceutical Product
20 MG 3 QID
Complaint
(PO)
2 MG 3 BID
HIGH DOSE
18-Aug-2005
Page: 512
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/08/04ISR Number: 4443812-0Report Type:Expedited (15-DaCompany Report #PHBS2004IL11384
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
UNKNOWN
PT
Report Source
Product
Role
Manufacturer
Route
Methylphenidate
PS
Novartis Sector:
Pharma
Product
Role
Manufacturer
Methylphenidate
PS
Novartis Sector:
Pharma
Product
Role
Manufacturer
Methylphenidate
PS
Novartis Sector:
Pharma
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Hallucinations, Mixed
.3 mg/kg, QD
Date:09/08/04ISR Number: 4443828-4Report Type:Expedited (15-DaCompany Report #PHBS2004IL11386
Age:12 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
UNKNOWN
PT
Report Source
Route
Duration
Hallucination
.3 mg/kg, QD
Date:09/08/04ISR Number: 4443829-6Report Type:Expedited (15-DaCompany Report #PHBS2004IL11387
Age:7 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
UNKNOWN
PT
Report Source
Route
Duration
Hallucinations, Mixed
Stress
.25 mg/kg, QD
Date:09/08/04ISR Number: 4443847-8Report Type:Expedited (15-DaCompany Report #PHNU2004DE02817
Age:
Gender:Male
I/FU:F
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Abdominal Pain Upper
Blood Creatine
Phosphokinase Increased
Blood Creatine
Phosphokinase Mb
Diarrhoea
Nausea
Report Source
Date:09/08/04ISR Number: 4443849-1Report Type:Expedited (15-DaCompany Report #PHRM2004FR02704
Age:40 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Bradycardia
Health
Professional
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
30 mg daily
Zoloft
Lithium
SS
SS
Date:09/10/04ISR Number: 4445603-3Report Type:Expedited (15-DaCompany Report #PHNU2004DE03154
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Duration
Vasculitic Rash
Unknown
Date:09/10/04ISR Number: 4445729-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040502040
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
OROPHARINGEAL
18-Aug-2005
Page: 513
11:49 AM
PT
Report Source
Product
Role
Aggression
Health
Concerta
PS
Condition Aggravated
Weight Decreased
Professional
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/10/04ISR Number: 4445832-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040809695
Age:
Gender:Male
I/FU:F
Outcome
Dose
Duration
Other
OROPHARINGEAL
PT
Report Source
Product
Role
Cerebellar Infarction
Concerta
PS
Cerebral Artery Occlusion
Ritalin
SS
Manufacturer
Route
Manufacturer
Route
OROPHARINGEAL
Date:09/10/04ISR Number: 4448389-1Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 226847
Report Source
Product
Role
Ritalin Brand Name
Med Necessary
PS
Xanax Brand Name Med
Necessary
SS
Duration
Drug Ineffective
Pharmaceutical Product
ORAL
20 MG 1 QID
Complaint
(PO)
2 MG 1 BID 3
QHS DOSE
Date:09/13/04ISR Number: 4449142-5Report Type:Expedited (15-DaCompany Report #LBID00204003065
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
PT
Report Source
Product
Role
Abdominal Pain
Atrioventricular Block
First Degree
Literature
Health
Professional
Lithium
Carbonate(Lithium
Carbonate)
PS
PO, 300 MG
Blood Thyroid Stimulating
QID PO
Hormone Decreased
Chest Pain
Conduction Disorder
Diarrhoea
Disorientation
Dizziness
Methylphenidate
(Methylphenidate
Hydrochloride)
Escitalopram
(Escitalopram)
Clonodine
SS
SS
Manufacturer
Route
ORAL
Drug Level Above
Therapeutic
Electrocardiogram Qrs
Complex Prolonged
Fluid Intake Reduced
Hyperhidrosis
Hypotension
Mania
Oral Intake Reduced
Pallor
Palpitations
Tachyarrhythmia
Therapeutic Agent
Toxicity
Ventricular Extrasystoles
Ventricular Tachycardia
Vomiting
White Blood Cell Count
Increased
Date:09/13/04ISR Number: 4449749-5Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
18-Aug-2005
Page: 514
PT
Aggression
Impulsive Behaviour
Pharmaceutical Product
11:49 AM
(Clonodine)
Company Report #CTU 226852
SS
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Complaint
Report Source
Dose
Product
Role
Ritalin - Brand Name
PS
Manufacturer
Route
Manufacturer
Route
Manufacturer
Route
Duration
20 MG SR
TWICE TAB
DAILY
Date:09/13/04ISR Number: 4449751-3Report Type:Direct
Age:14 YR
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 226853
Report Source
No Adverse Drug Effect
20 MG SR
Product
Role
Ritalin
PS
Duration
2
TABS DAILY
Date:09/15/04ISR Number: 4449858-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040901057
Age:13 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
OROPHARINGEAL
PT
Report Source
Product
Role
Leukopenia
Health
Concerta
PS
Monocytosis
Neutropenia
Professional
Date:09/15/04ISR Number: 4449950-0Report Type:Expedited (15-DaCompany Report #PHNU2004DE02303
Age:
Gender:Female
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Death
Overdose
Health
Professional
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Unknown
Poisoning Deliberate
Unknown
Asa
C
ORAL
Furosemide
C
ORAL
Haldol "Janssen"
C
ORAL
Digitoxin
C
ORAL
Unknown
Unknown
Unknown
Date:09/15/04ISR Number: 4449994-9Report Type:Expedited (15-DaCompany Report #PHBS2004JP11753
Age:25 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
Duration
Drug Abuser
Theft
40 mg/d
Ritaline
SS
3 - 4 DF/d
INTRAVENOUS
Ritaline
SS
Novartis Sector:
Pharma
Ritaline
SS
Novartis Sector:
Pharma
Mianserin
C
Sulpiride
C
Fluoxetine
C
Sulpiride
C
1 DF, QD to
TID
INTRAVENOUS
45 mg/day
UNKNOWN
20 mg/d
UNKNOWN
300 mg/d
3 DF/day
INTRAVENOUS
18-Aug-2005
Page: 515
60 mg/d
11:49 AM
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/15/04ISR Number: 4450006-1Report Type:Expedited (15-DaCompany Report #PHBS2004JP10015
Age:75 YR
Gender:Female
I/FU:F
Outcome
Dose
Death
Other
10 mg/d
20 mg/d
PT
Report Source
Product
Role
Manufacturer
Route
Death
Delirium
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Depressed Level Of
Consciousness
Ritalin
Novartis Sector:
Pharma
ORAL
Dizziness
Malaise
Oxygen Saturation
Morphine
Hydrochloride
Durotep
C
C
Decreased
Diovan
C
ORAL
Somnolence
Speech Disorder
Tremor
Protecadin
Loxonin
Ganaton
C
C
C
ORAL
Vomiting
Rize
C
ORAL
Novamin
C
ORAL
Duration
SS
5760 MIN
25 mg/d
80 mg/d
150 mg/d
15 mg/d
15 mg/d
Date:09/15/04ISR Number: 4450027-9Report Type:Expedited (15-DaCompany Report #PHBS2004JP11891
Age:33 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Priapism
Health
Professional
Ritaline
PS
Novartis Sector:
Pharma
Tegretol
Akineton
Erimin
Wintermin
Risperdal
Depas
Myslee
SS
SS
SS
SS
SS
SS
SS
Route
Duration
Date:09/15/04ISR Number: 4450029-2Report Type:Expedited (15-DaCompany Report #PHFR2004GB03398
Age:
Gender:Male
I/FU:I
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
Outcome
Dose
Other
UNKNOWN
PT
Report Source
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Pharma
Antibiotics
C
Route
Duration
Benign Intracranial
Hypertension
40mg/day
UNKNOWN
Date:09/15/04ISR Number: 4450040-1Report Type:Expedited (15-DaCompany Report #PHNU2004DE03197
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Strabismus
Health
Professional
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Unknown
Medikinet
SS
ORAL
Unknown
Date:09/15/04ISR Number: 4451998-7Report Type:Direct
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization PO [PRIOR TO
Initial or Prolonged
ADMISSION]
18-Aug-2005
Page: 516
11:49 AM
PT
Headache
Company Report #CTU 227206
Report Source
Product
Role
Ritalin
PS
Albuterol
C
Vomiting
Manufacturer
Route
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/16/04ISR Number: 4451377-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040901570
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
OROPHARINGEAL
PT
Report Source
Vasoconstriction
Product
Role
Concerta Xl
PS
Melatonin
C
Manufacturer
Route
Manufacturer
Route
UNKNOWN
Date:09/16/04ISR Number: 4451378-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040504699
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization OROPHARINGEAL
Initial or Prolonged
PT
Report Source
Product
Role
Acute Pulmonary Oedema
Health
Concerta
PS
Anaesthetic Complication
Cardiac
Anaesthetic Complication
Pulmonary
Drug Interaction
Malignant Hypertension
Tachycardia
Professional
Neo-Synephrine
Propofol
Fentanyl
Midazolam
Rocuronium
SS
SS
C
C
C
NASAL
Date:09/16/04ISR Number: 4451379-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040704183
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
OROPHARINGEAL
PT
Report Source
Product
Role
Haematuria
Health
Concerta Xl
PS
Vasculitis Necrotising
Professional
Manufacturer
Route
Manufacturer
Route
Date:09/16/04ISR Number: 4452897-7Report Type:Expedited (15-DaCompany Report #2004029622
Age:52 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Anticonvulsant Drug Level
Consumer
Dilantin Kapseals
Duration
Role
Decreased
(Phenytoin Sodium)
PS
Increased
Convulsion
Phenytoin
(Phenytoin)
SS
Drug Effect Decreased
Epilepsy
Fatigue
Ill-Defined Disorder
Memory Impairment
Nervousness
Pharmaceutical Product
Complaint
Treatment Noncompliance
Methylphenidate
Hydrochloride
(Methylphenidate
Hydrochloride)
Gabapentin
(Gabapentin)
Clonazepam
(Clonazepam)
Buspirone
Hydrochloride
(Buspirone
Hydrochloride)
Tamsulosin
Hydrochloride
(Tamsulosin
Hydrochloride)
Enalapril Maleate
(Enalapril Maleate)
Yohimbine
(Yohimbine)
Axotal (Old Form)
(Butalbital,
Caffeine,
300 MG (1 D),
Anticonvulsant Drug Level
ORAL
500 MG (1 D)
18-Aug-2005
Page: 517
11:49 AM
SS
C
C
C
C
C
C
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Paracetamol)
Donepezil
Hydrochloride
(Donepezil
Hydrochloride)
Lomotil (Atropine
Sulfate,
Diphenoxylate
Hydrochloride)
C
C
C
Date:09/16/04ISR Number: 4452910-7Report Type:Expedited (15-DaCompany Report #2004-DE-04634GD
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Hospitalization Initial or Prolonged
1200 MG
Required
(TWICE
Intervention to
DAILY),
Prevent Permanent
Impairment/Damage
0.4 MG (TWICE
PT
Report Source
Product
Role
Abdominal Pain
Atrioventricular Block
Literature
Lithium Carbonate
(Lithium Carbonate)
PS
Clonidine
(Clonidine)
SS
Methylphenidate
(Methylphenidate)
SS
Escitalopram
(Escitalopram)
SS
Oxacarbazine
(Antiepileptics)
SS
First Degree
Chest Pain
Conduction Disorder
Diarrhoea
Disorientation
DAILY)
Dizziness
Drug Interaction
36 MG (ONCE
Drug Level Increased
DAILY), IN
Electrocardiogram Qrs
THE MORNING
Complex Prolonged
Hyperhidrosis
10 MG (ONCE
Hypotension
DAILY),
Hypothyroidism
Oral Intake Reduced
600 MG (ONCE
Pallor
DAILY)
Palpitations
Depakote (Valproate
Manufacturer
Route
Tachyarrhythmia
Semisodium)
SS
Levothyroxine
(Levothyroxine)
SS
1500 MG (ONE
Tachycardia
THIRD OF
Therapeutic Agent
DAILY DOSE IN
Toxicity
THE MORNING
Ventricular Extrasystoles
AND TWO
Ventricular Tachycardia
Vomiting
White Blood Cell Count
Increased
Date:09/17/04ISR Number: 4451971-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040903736
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
OROPHARINGEAL
PT
Report Source
Product
Role
Apraxia
Concerta
PS
Asthenia
Concerta
SS
OROPHARINGEAL
Brain Neoplasm
Cerebral Cyst
Hypoaesthesia
Date:09/17/04ISR Number: 4452383-4Report Type:Expedited (15-DaCompany Report #PHBS2004JP10015
Age:75 YR
Gender:Female
I/FU:F
Outcome
Death
Other
18-Aug-2005
Page: 518
PT
Death
Delirium
Depressed Level Of
11:49 AM
Manufacturer
Route
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Consciousness
Dizziness
Malaise
Oxygen Saturation
Dose
Report Source
Product
Role
Manufacturer
Route
Decreased
Somnolence
Ritalin
PS
Novartis Sector:
Pharma
ORAL
Speech Disorder
Tremor
Ritalin
Novartis Sector:
Pharma
ORAL
Vomiting
Morphine
Hydrochloride
Durotep
C
C
Diovan
C
ORAL
Protecadin
Loxonin
Ganaton
C
C
C
ORAL
Rize
C
ORAL
Novamin
C
ORAL
Duration
10 mg/d
20 mg/d
SS
5760 MIN
25 mg/d
80 mg/d
150 mg/d
15 mg/d
15 mg/d
Date:09/17/04ISR Number: 4452384-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB03398
Age:
Gender:Male
I/FU:I
Outcome
Dose
Other
UNKNOWN
PT
Report Source
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Pharma
Antibiotics
C
Route
Duration
Benign Intracranial
Hypertension
40mg/day
UNKNOWN
Date:09/17/04ISR Number: 4452385-8Report Type:Expedited (15-DaCompany Report #PHBS2004JP11753
Age:25 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Duration
Drug Abuser
Route
Medication Error
Pharma
ORAL
Novartis Sector:
Pharma
ORAL
40 mg/d
Theft
Ritaline
SS
3 - 4 DF/d
INTRAVENOUS
Ritaline
SS
Novartis Sector:
Pharma
Ritaline
SS
Novartis Sector:
Pharma
Mianserin
C
Sulpiride
C
Fluoxetine
C
Sulpiride
C
1 DF, QD to
TID
INTRAVENOUS
45 mg/day
UNKNOWN
20 mg/d
UNKNOWN
300 mg/d
ORAL
3 DF/day
INTRAVENOUS
60 mg/d
Date:09/17/04ISR Number: 4452387-1Report Type:Expedited (15-DaCompany Report #PHBS2004JP11891
Age:33 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
18-Aug-2005
Page: 519
PT
Report Source
Product
Role
Manufacturer
Ritaline
PS
Novartis Sector:
Pharma
Tegretol
Akineton
Erimin
Wintermin
Risperdal
Depas
Myslee
SS
SS
SS
SS
SS
SS
SS
Route
Duration
Priapism
11:49 AM
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Date:09/17/04ISR Number: 4452388-3Report Type:Expedited (15-DaCompany Report #PHNU2004DE03197
Age:
Gender:Female
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Duration
Strabismus
Unknown
Medikinet
SS
ORAL
Unknown
Date:09/17/04ISR Number: 4452411-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE02303
Age:
Gender:Female
I/FU:F
Outcome
Dose
Death
PT
Report Source
Product
Role
Manufacturer
Route
Death
Overdose
Ritaline
PS
Novartis Sector:
Pharma
ORAL
Poisoning Deliberate
Asa
C
ORAL
Furosemide
C
ORAL
Haldol "Janssen"
C
ORAL
Digitoxin
C
ORAL
Duration
Unknown
Unknown
Unknown
Unknown
Unknown
Date:09/17/04ISR Number: 4454414-4Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
PT
Company Report #CTU 227479
Report Source
Product
Role
Manufacturer
Route
Ritalin Brand Name
Med Necessary
PS
ORAL
Xanax Brand Name Med
Necessary
SS
ORAL
Duration
Drug Ineffective
20 MG 1 QID
(PO)
2 MG 1 BID 3
QID PO
Date:09/17/04ISR Number: 4454445-4Report Type:Direct
Age:
Gender:Male
I/FU:I
Outcome
Dose
Duration
Required
Intervention to
20MG QID ORAL
Prevent Permanent
Impairment/Damage
PT
Company Report #CTU 227450
Report Source
Blood Pressure Increased
Condition Aggravated
Product
Role
Manufacturer
Route
Methylphenidate Sr
20 Mg
Geneva
PS
Geneva
ORAL
Hydrochlorothiazide
Etodolac
Wellbutrin
Lisinopril
Aciphex
C
C
C
C
C
Manufacturer
Route
Date:09/17/04ISR Number: 4455545-5Report Type:Expedited (15-DaCompany Report #CEL-2004-01480-ROC
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Duration
Other
Required
Intervention to
Prevent Permanent
Impairment/Damage
10MG,
PT
Report Source
Product
Role
Headache
Mydriasis
Optic Atrophy
Visual Disturbance
Health
Professional
Metadate Cd Capsules
(Strength
Unspecified)
(Methylphenidate
Hydrochloride)
PS
INCREASED TO
20 MG THEN
DECREASED TO
10MG, QAM,
Strattera
Ddavp (Desmopressin)
Luvox (Fluvoxamine
18-Aug-2005
Page: 520
11:49 AM
C
C
ORAL
FDA - Adverse Event Reporting System (AERS)
Freedom Of Information (FOI) Report
Maleate)
C
Date:09/20/04ISR Number: 4453340-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB02985
Age:6 YR
Gender:Male
I/FU:F
Outcome
Dose
Other
UNKNOWN
PT
Report Source
Product
Role
Manufacturer
Health
Professional
Ritaline
PS
Novartis Sector:
Pharma
Route
Duration
Asthma
Condition Aggravated
5 mg, BID
Date:09/20/04ISR Number: 4453343-XReport Type:Expedited (15-DaCompany Report #PHBS2004BR12227
Age:10 YR
Gender:Male
I/FU:I
Outcome
Dose
Other
PT
Report Source
Product
Role
Manufacturer
Route
Hyperthyroidism
Consumer
Ritalina
PS
Novartis Sector:
Pharma
ORAL
Manufacturer
Route
Manufacturer
Route
Duration
1 DF, QD
Date:09/20/04ISR Number: 4453417-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040901570
Age:9 YR
Gender:Male
I/FU:I
Outcome
Dose
Duration
Other
OROPHARINGEAL
PT
Report Source
Product
Role
Vasoconstriction
Health
Concerta Xl
PS
Professional
Melatonin
C
UNKNOWN
Date:09/20/04ISR Number: 4453418-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040504699
Age:
Gender:Female
I/FU:I
Outcome
Dose
Duration
Hospitalization OROPHARINGEAL
Initial or Prolonged
PT
Report Source
Product
Role
Acute Pulmonary Oedema
Health
Concerta
PS
Drug Interaction
Malignant Hypertension
Tachyc