FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/97ISR Number: 100000057Report Type:Expedited (15-DaCompany Report #97HQ-10259 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Anafranil PS 150 MG, DAILY Agitation Literature Erythromycin SS 750 MG, DAILY Drug Interaction Health Risperidone SS 1 MG, DAILY Mood Altered Professional Other Date:11/03/97ISR Number: 3013109-4Report Type:Periodic Company Report #001-0970-970488 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Consumer Cognex PS 40 MG, QID, Fatigue UNKNOWN Hallucination Risperdal SS 2 MG, UNKNOWN Zestril C Tenormin C Occupress C Macrodantin C Colace C Centrum Silver C Xalatam C Date:11/04/97ISR Number: 100000150Report Type:Expedited (15-DaCompany Report #JAFRA-35167 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Risperdal PS Janssen ORAL 1 MG 1 DAILY Aspiration Health ORAL Asthenia Professional Risperdal SS ORAL 2MG DAILY Fall ORAL 3 DAY Loss Of Consciousness Risperdal SS ORAL 2 MG 2 DAILY Malaise Depamide SS ORAL 1200MG DAILY Mania ORAL Pallor Largactil SS ORAL Resuscitation Noctamide SS ORAL 1 DAILY ORAL 16 DAY Lepticur SS ORAL 10MG 1 DAILY ORAL 4 DAY Risperdal SS ORAL 2 MG 3 DAILY 2 DAY Date:11/04/97ISR Number: 100000150Report Type:Expedited (15-DaCompany Report #JAUSA-28540 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Risperdal Professional (Risperidone) PS Janssen, Tablet 1 Mg ORAL 1 MG 2 DAILY ORAL Rispedal (Risperidone) SS ORAL 4 MG 2 DAILY Cogentin (Benztropine) C Prozac (Fuloxetine) C 22-Feb-2006 08:20 AM Page: 1 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/97ISR Number: 3005563-9Report Type:Direct Company Report # Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperpyrexia Health Risperidone PS Initial or Prolonged Temperature Regulation Professional Disorder Date:11/06/97ISR Number: 3005650-5Report Type:Direct Company Report # Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Risperidone PS ORAL 0.5MG, TID PO Intervention to Klonopin C Prevent Permanent Impairment/Damage Date:11/06/97ISR Number: 3005663-3Report Type:Direct Company Report # Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperidone PS 0.25MG Q HS Initial or Prolonged Phosphokinase Increased CHRONIC Dehydration Prozac C Dementia Ativan C Emotional Disorder Synmetrol C Hyperhidrosis Riperdal C Muscle Rigidity Neuroleptic Malignant Syndrome Parkinsonism Pyrexia Date:11/12/97ISR Number: 3000328-6Report Type:Expedited (15-DaCompany Report #8789-AR Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Orap (Pimozide) Initial or Prolonged Prolonged Professional Tablets 2mg PS Other Risperidone SS Date:11/12/97ISR Number: 3000539-XReport Type:Expedited (15-DaCompany Report #FLUV002970427 Age:11 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Luvox PS ORAL 75 MG, ORAL Drug Interaction Professional Risperdal SS ORAL 1ST DOSE Sedation REGIMEN - UNKNOWN, ORAL; 2ND: 1.5 MG ORAL 22-Feb-2006 08:20 AM Page: 2 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/97ISR Number: 3000895-2Report Type:Expedited (15-DaCompany Report #B0050640 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Kemadrin PS ORAL 5 MG/THREE Hospitalization - Dna Antibody Positive Health TIMES PER Initial or Prolonged Fatigue Professional DAY/ORAL TAB Proteinuria Flupenthixol Hc1 SS INTRAMUSCULAR 40 Raynaud'S Phenomenon MG/WEEKLY/INT Schizophrenia RAMUSCULAR Systemic Lupus Risperidone SS ORAL 2 MG/THREE Erythematosus TIMES PER DAY/ORAL Chlorpromazine C Date:11/17/97ISR Number: 3000906-4Report Type:Expedited (15-DaCompany Report #JAUSA-30301 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalopathy Health Risperdal PS Janssen ORAL ORAL Initial or Prolonged Professional Date:11/17/97ISR Number: 3000908-8Report Type:Expedited (15-DaCompany Report #JAFRA-35951 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Face Oedema Foreign Risperdal PS Janssen ORAL Initial or Prolonged Hypernatraemia Health Depamide SS Weight Increased Professional Date:11/17/97ISR Number: 3000909-XReport Type:Expedited (15-DaCompany Report #JAUSA-30326 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen ORAL 18 MG DAILY Professional ORAL Trazodone C Artane C Zyprexa C Klonopin C Date:11/17/97ISR Number: 3006072-3Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Risperidone PS ORAL 2MG PO BID Obsessive-Compulsive Prozac C Disorder Axid C Benadryl C Depo Provera C Date:11/18/97ISR Number: 3005856-5Report Type:Direct Company Report # Age:88 YR Gender:Female I/FU:I Outcome PT Abdominal Distension Abdominal Tenderness 22-Feb-2006 08:20 AM Page: 3 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Faecaloma Ileus Paralytic Pyrexia Report Source Product Role Manufacturer Route Dose Duration Urinary Tract Infection Risperidone PS ORAL 0.5 MG PO BID Date:11/20/97ISR Number: 3005763-8Report Type:Direct Company Report # Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Jittery Risperidone PS ORAL 5 MG BID PO Initial or Prolonged Joint Stiffness Muscle Rigidity Parkinsonian Gait Parkinsonism Date:11/21/97ISR Number: 3002209-0Report Type:Expedited (15-DaCompany Report #001-0945-970680 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Health Neurontin PS ORAL 300 MG TID, Initial or Prolonged Gastroenteritis Professional PER ORAL Helicobacter Risperidone Joint Stiffness (Risperidone) SS Sedation Prevacid (Lansoprazole) C Propulsid (Cisapride) C Xanax (Alprazolam) C Date:11/21/97ISR Number: 3002275-2Report Type:Expedited (15-DaCompany Report #JAUK-36216 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alveolitis Fibrosing Foreign Risperidone (Risperidone), Tablet PS Janssen ORAL 8 MG DAILY ORAL Date:11/21/97ISR Number: 3002276-4Report Type:Expedited (15-DaCompany Report #JAUSA-30419 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Health Risperdal Distress Syndrome Professional (Risperidone ), Aspiration Tablet PS Janssen ORAL 1 MG DAILY Condition Aggravated ORAL Status Epilepticus Date:11/25/97ISR Number: 3002622-1Report Type:Expedited (15-DaCompany Report #JAUSA-30372 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Risperdal PS Janssen Research Professional Foundation ORAL 6MG; 1 TABLET DAILY; ORAL Mellaril C 22-Feb-2006 08:20 AM Page: 4 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Synthroid C Date:11/25/97ISR Number: 3002624-5Report Type:Expedited (15-DaCompany Report #JAUK-33278 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Risperidone PS ORAL 1 MG 3 DAILY Hospitalization - Hypotension Health ORAL TAB Initial or Prolonged Hypothermia Professional Frusemide C Theiohyllin C Lisinopril C Date:11/25/97ISR Number: 3002627-0Report Type:Expedited (15-DaCompany Report #JAUK-36278 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Systemic Lupus Foreign Risperdal PS ORAL 6 MG DAILY Initial or Prolonged Erythematosus Health ORAL; 2MG AM, Professional 4 MG NOCTE; Other USED FOR OVER 3 MONTHS Depixol SS INTRAMUSCULAR 40 MG; 1 WEEKLY; INTRAMUSCULAR ; USED FOR OVER 3 MONTHS Date:11/25/97ISR Number: 3006159-5Report Type:Direct Company Report # Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Cold Risperidone PS Janssen 2MG BID Muscle Spasms Trifluoperazine Hcl SS Bolar 5 MG DAY Parosmia Vision Blurred Date:11/25/97ISR Number: 3038666-3Report Type:Periodic Company Report #9704905 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Sinequan PS ORAL Akathisia Haldol Decanoate SS INTRAMUSCULAR 125.00 MG Blunted Affect TOTAL:MONTHLY Constipation Risperdal SS ORAL 4.00 MG Drug Interaction TOTAL:BID Euphoric Mood Cogentin C Tremor Date:11/26/97ISR Number: 3002924-9Report Type:Expedited (15-DaCompany Report #JAUSA-27702 Age:50 YR Gender:Female I/FU:F Outcome PT Other Asthenia Chest Pain Constipation Difficulty In Walking 22-Feb-2006 08:20 AM Page: 5 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyspnoea Hypoaesthesia Multiple Sclerosis Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Consumer Risperdal PS ORAL 80MG DAILY Neuropathy Peripheral ORAL Pain Zyprexa C Paraesthesia Depakote C Urinary Incontinence Milk Of Magnesia C Date:12/01/97ISR Number: 3003007-4Report Type:Expedited (15-DaCompany Report #971121-008013188 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Foreign Haldol PS ORAL ORAL Hypokalaemia Health Risperidone SS ORAL ORAL Hyponatraemia Professional Cisapride SS ORAL 10 MG, TID, ORAL Buflomedil SS ORAL 15O MG, QD, ORAL Propafenone SS 300 MG, QD Zopiclone SS ORAL 7.5 MG,ORAL Paroxetine SS ORAL 20 MG, ORAL Macrogol SS ORAL ORAL Gaviscon SS ORAL ORAL Efferalgan SS ORAL ORAL Unknown C Date:12/01/97ISR Number: 3003494-1Report Type:Expedited (15-DaCompany Report #JAFRA-36318 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Propulsid PS Janssen ORAL 10 MG 3 DAILY Health ORAL Professional Risperdal SS Janssen ORAL .5 MG DAILY Other ORAL Haldol SS ORAL 25 DROPS/DAY 1 DAILY Fonzylane SS ORAL 150 MG DAILY ORAL Rythmol SS ORAL 150 MG 3 DAILY Imovane SS ORAL 7.5 MG 1 DAILY ORAL Transipeg SS ORAL ORAL Gaviscon SS ORAL ORAL Efferalgan SS Deroxat C ORAL 20 MG 1 DAILY ORAL Date:12/02/97ISR Number: 3004115-4Report Type:Expedited (15-DaCompany Report #N/96/00043/LEX Age:40 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:20 AM Page: 6 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Hypercapnia Health Leponex PS ORAL 100 MG ORAL Hypoxia Professional Risperdal SS ORAL 8 MG ORAL Respiratory Disorder Petidin SS 100 MG Dormicum SS UNSPECIFIED Rapifen SS UNSPECIFIED Date:12/05/97ISR Number: 3003968-3Report Type:Expedited (15-DaCompany Report #JAUSA-30492 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Risperdal PS ORAL 4.5 MG DAILY Initial or Prolonged Disorientation Professional ORAL Dizziness Depakote C Encephalopathy Clozapine C Muscle Rigidity Parkinsonian Gait Date:12/05/97ISR Number: 3003972-5Report Type:Expedited (15-DaCompany Report #JAKYO-35296 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholinesterase Foreign Risperidone PS Janssen ORAL 5 MG DAILY Initial or Prolonged Decreased Health Haloperidol C Cerebral Infarction Professional Diazepam C Depressed Level Of Sennosides C Consciousness Biperiden C Diarrhoea Thioridazine C Hyperhidrosis Zotepine C Hypoxic Encephalopathy Timiperone C Increased Bronchial Secretion Miosis Pneumonia Pulmonary Oedema Pyrexia Respiratory Arrest Speech Disorder Date:12/05/97ISR Number: 3003975-0Report Type:Expedited (15-DaCompany Report #JAFRA-36319 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Risperdal PS Janssen ORAL 1 MG DAILY Life-Threatening Abdominal Pain Upper Health Dipiperon SS Janssen ORAL 20 MG DAILY Bradycardia Professional ORAL Cerebrovascular Accident Equanil SS ORAL 250 MG; 3 Cyanosis DAILY; ORAL Delirium Athymil SS ORAL 60 MG 1 DAILY Dyspnoea ORAL Flatulence Imovane SS ORAL 7.5 MG; 1 Hypertensive Crisis DAILY; ORAL Loss Of Consciousness Akineton SS ORAL 4 MG DAILY; Malaise ORAL Urinary Incontinence Lactulose SS 10 G 22-Feb-2006 08:20 AM Page: 7 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/97ISR Number: 3018319-8Report Type:Direct Company Report # Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Risperdal PS Janssen ORAL 4 MG BID TAB Anxiety Professional Dermatitis Dyspepsia Headache Nausea Tachycardia Vomiting Date:12/09/97ISR Number: 3004564-4Report Type:Expedited (15-DaCompany Report #JACAN-16535 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oligohydramnios Foreign Risperdal PS ORAL ORAL Premature Baby Health Professional Date:12/09/97ISR Number: 3004648-0Report Type:Expedited (15-DaCompany Report #JACAN-16553 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Risperdal PS ORAL ORAL Circulatory Collapse Health Professional Date:12/11/97ISR Number: 3006472-1Report Type:Expedited (15-DaCompany Report #JAKYO-33785 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Risperdal PS Janssen ORAL 6 MG DAILY Initial or Prolonged Depressed Level Of Health Impromen C Consciousness Professional Nimetazepam C Empyema Rohypnol C Encephalopathy Hirnamin C Hepatic Function Abnormal Tasmolin C Neuroleptic Malignant Syndrome Pneumonia Pyrexia Respiratory Failure Sedation Date:12/11/97ISR Number: 3007633-8Report Type:Direct Company Report # Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Risperdal PS ORAL 6 MG QD 1 YR Sedation Benztropine C Urinary Incontinence Luvox C Weight Increased 22-Feb-2006 08:20 AM Page: 8 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/97ISR Number: 3006919-0Report Type:Expedited (15-DaCompany Report #JAKYO-32632 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Risperdal PS Janssen ORAL 3MG DAILY Health ORAL;1MG Professional DAILY Valproate Sodium C Pantethine C Magnesium Oxide C Lactomin C Estazolam C Zotepine C Levomepromazine C Date:12/15/97ISR Number: 3006984-0Report Type:Direct Company Report # Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Health Risperdal PS ORAL 1.5 MG BID PO Gynaecomastia Professional Other Date:12/15/97ISR Number: 3009468-9Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperidone PS ORAL 2 G BID Dry Skin Extrapyramidal Disorder Libido Decreased Tachycardia Tremor Date:12/16/97ISR Number: 3008067-2Report Type:Expedited (15-DaCompany Report #JAUK-33278 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Risperidone PS Janssen ORAL 1 MG 2 DAILY Life-Threatening Depressed Level Of ORAL Hospitalization - Consciousness Frusemide C Initial or Prolonged Hypotension Theophyllin Hypothermia (Theophylline) C Lisinopril (Lisinopril) C Co-Proxamol C Date:12/16/97ISR Number: 3008283-XReport Type:Direct Company Report # Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Risperdal PS Janssen ORAL 6MG PO BID Required Thorazine C Intervention to Trazodone C Prevent Permanent Paxil C Impairment/Damage Klonopin C Lasix C Zestril C 22-Feb-2006 08:20 AM Page: 9 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premarin C Date:12/16/97ISR Number: 3008286-5Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Risperdal PS Janssen ORAL 1MG PO BD Intervention to Depakote C Prevent Permanent Lithium C Impairment/Damage Prilosec C Trazode C Restoril C Date:12/16/97ISR Number: 3008288-9Report Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Restlessness Risperdal PS Janssen ORAL 1MG BID PO Synthroid C Effexor C Date:12/16/97ISR Number: 3008289-0Report Type:Direct Company Report # Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Risperdal PS Janssen ORAL 1/2MG PO BID Extrapyramidal Disorder Clonidine C Prozac C Date:12/16/97ISR Number: 3008337-8Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Risperidone PS ORAL 2 MG PO BID Obsessive-Compulsive Prozac C Disorder Axid C Benadryl C Depo-Provera C Date:12/17/97ISR Number: 3010089-2Report Type:Expedited (15-DaCompany Report #9726081 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Rash Erythematous Health Navane PS ORAL 10.00 MG Intervention to Swelling Professional TOTAL:DAILY:O Prevent Permanent RAL Impairment/Damage Risperdal SS ORAL ORAL Date:12/22/97ISR Number: 3012638-7Report Type:Expedited (15-DaCompany Report #JAFRA-35572 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Foreign Risperdal PS Janssen ORAL 2 MG 1 DAILY Hospitalization - Dyskinesia Health ORAL Initial or Prolonged Pain Professional Risperdal SS ORAL 4 MG 1 DAILY 23 DAY 22-Feb-2006 08:20 AM Page: 10 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal SS ORAL 2 MG 1 DAILY 5 WK Date:12/22/97ISR Number: 3012642-9Report Type:Expedited (15-DaCompany Report #JAUSA-30704 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Risperdal PS ORAL 10 MON Life-Threatening Professional Date:12/22/97ISR Number: 3012703-4Report Type:Expedited (15-DaCompany Report #JAHOL-36853 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oedema Peripheral Foreign Risperdal PS ORAL 4MG2DAILY Pain In Extremity Health ORAL Pulmonary Embolism Professional Temazepam C Promethazine C Oxazepam C Date:12/23/97ISR Number: 3012061-5Report Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperaesthesia Risperidone PS Jannsen 3MG BID PO Intervention to Pain Prevent Permanent Priapism Impairment/Damage Date:12/23/97ISR Number: 3012092-5Report Type:Direct Company Report # Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Risperdal PS Janssen ORAL 0.5MG PO BID; Initial or Prolonged Pyrexia TAB Required Depakote C Intervention to Prevent Permanent Impairment/Damage Date:12/29/97ISR Number: 3014364-7Report Type:Expedited (15-DaCompany Report #JAUSA-30809 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Health Risperdal PS Janssen ORAL ORAL Initial or Prolonged Blood Lactate Professional Dehydrogenase Increased Coombs Direct Test Positive Dizziness Fatigue Haematocrit Decreased Haemoglobin Decreased Haemolytic Anaemia 22-Feb-2006 08:20 AM Page: 11 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/97ISR Number: 3014368-4Report Type:Expedited (15-DaCompany Report #JAUSA-30326 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Risperdal PS Janssen ORAL 18 MG DAILY, Professional ORAL Trazodone C Artane C Zyprexa C Klonopin C Date:12/29/97ISR Number: 3015056-0Report Type:Expedited (15-DaCompany Report #001-0945-970680 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Health Neurontin PS ORAL 900 MG (300 Initial or Prolonged Blood Thyroid Stimulating Professional MG, TID) PER Hormone Increased ORAL 1 MON Joint Stiffness Risperidone SS ORAL 0.5 MG (,HS), Reiter'S Syndrome PER ORAL Sedation Xanax C Thyroxine Decreased Prevacid C Propulsid C Date:12/30/97ISR Number: 3015260-1Report Type:Direct Company Report # Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Risperdal PS Janssen ORAL 0.5 MG PO Body Temperature BID; AT LEAST Decreased 3 MONTHS THERAPY 3 MON Alendronate C Amitriptyline C Calcium C Enalapril C Furosemide C Multivitamins C Nu-Iron C Potassium Chloride C Zolpidem C Date:12/31/97ISR Number: 3012884-2Report Type:Direct Company Report # Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Resperidol PS TITRATE 3MG Initial or Prolonged Phosphokinase Increased BID Depressed Level Of Haloperidol SS Consciousness Feeling Jittery Neuroleptic Malignant Syndrome Pyrexia 22-Feb-2006 08:20 AM Page: 12 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/02/98ISR Number: 3013826-6Report Type:Expedited (15-DaCompany Report #JAGER-27702 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Risperdal PS Janssen ORAL 12 MG DAILY Initial or Prolonged Blood Creatine Health ORAL Phosphokinase Increased Professional Laxoberal C Hypochondriasis Lactulose C Infection Muscle Rigidity Muscular Weakness Myalgia Pneumonia Polyuria Pyrexia Rales Restlessness Rhabdomyolysis Tachycardia Tenderness Vomiting Date:01/02/98ISR Number: 3013829-1Report Type:Expedited (15-DaCompany Report #JAFRA-37077 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal PS Janssen ORAL 2 MG DAILY Initial or Prolonged Phosphokinase Increased Health ORAL Myalgia Professional Tercian C Myoglobinuria Coversyl C Renal Impairment Rhabdomyolysis Date:01/02/98ISR Number: 3013832-1Report Type:Expedited (15-DaCompany Report #JAKYO-37064 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Foreign Risperdal PS Janssen ORAL 6 MG DAILY Health ORAL Professional Haloperidol Decanoate SS Janssen INTRAMUSCULAR 100 MG INTRAMUSCULAR Date:01/02/98ISR Number: 3013835-7Report Type:Expedited (15-DaCompany Report #JASWE-36976 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Vasculitis Foreign Risperidone PS Janssen ORAL 4 MG 2 DAILY Initial or Prolonged Health ORAL Professional Litarex C Cisordinol Depot C Disipal C 22-Feb-2006 08:20 AM Page: 13 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/02/98ISR Number: 3013837-0Report Type:Expedited (15-DaCompany Report #JASWE-36975 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Vasculitis Foreign Risperidone PS Janssen ORAL 2 MG DAILY Initial or Prolonged Health ORAL 1 YR Professional Zoloft C Effexor C Date:01/02/98ISR Number: 3014210-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Zyprexa PS ORAL TABS; 20 MG Joint Stiffness PO HS Restlessness Risperdal SS ORAL TABS; 2 MG PO BID Triphasil-28 C Date:01/02/98ISR Number: 3014216-2Report Type:Direct Company Report # Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Paxil PS Skb ORAL 20 MG QAM PO Hospitalization - Infection Olanzapine SS Lilly ORAL 5 MG Q HS PO Initial or Prolonged Pyrexia Risperdal SS Janssen ORAL 2MG PO BID Required Serotonin Syndrome (TAPERING) Intervention to Tremor Sinemet C Prevent Permanent Ativan C Impairment/Damage Colace C Levothyroxine C Multivitamin C Axid C Tegretol C Date:01/08/98ISR Number: 3015495-8Report Type:Direct Company Report # Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Insipidus Risperdal PS 1 MG QD Initial or Prolonged Date:01/08/98ISR Number: 3017154-4Report Type:Expedited (15-DaCompany Report #JAUSA-30902 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Consumer Risperdal PS Janssen ORAL 3 MG DAILY ORAL Prozac C Temazepam C Date:01/12/98ISR Number: 3018461-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Hospitalization - Hypertonia Initial or Prolonged Hypotension 22-Feb-2006 08:20 AM Page: 14 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypothermia Joint Stiffness Pyrexia Report Source Product Role Manufacturer Route Dose Duration Risperidol PS ORAL 0.5 MG PO BID Paxil SS ORAL 20 MG PO QD Dantrolene C IVP Oxygen C Date:01/13/98ISR Number: 3016621-7Report Type:Expedited (15-DaCompany Report #001-0945-970680 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Health Neurontin PS ORAL 900 MG (300 Initial or Prolonged Blood Thyroid Stimulating Professional MG, TID), PER Hormone Increased ORAL Joint Stiffness Risperidone SS ORAL 0.5 MG (,HS), Sedation PER ORAL Thyroxine Decreased Depakote C Xanax C Prevacid C Propulsid C Mellaril C Date:01/14/98ISR Number: 3016959-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Flat Affect Risperidal PS ORAL 2MG PO BID; Muscle Rigidity NDC#50458-032 Psychomotor Retardation 0-01 Zyprexa SS ORAL 15 MG PO Q 9 PM; NDC# 0002-4115-33 Zyprexa SS 15MG PO Q9PM; NDC# 0002-4117-33 Date:01/15/98ISR Number: 3018444-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Discharge Risperdal PS Janssen 2MG @0800 HS Galactorrhoea & 1MG @ 1200 Hyperprolactinaemia Date:01/20/98ISR Number: 3017412-3Report Type:Expedited (15-DaCompany Report #JAUSA-25008 Age:48 YR Gender:Male I/FU:F Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Mm Increased Bundle Branch Block Left Cellulitis Condition Aggravated Convulsion Cyanosis 22-Feb-2006 08:20 AM Page: 15 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrocardiogram St Segment Elevation Hyperglycaemia Report Source Product Role Manufacturer Route Dose Duration Hyponatraemia Literature Risperdal PS ORAL 1MG 2 DAILY Inappropriate Health ORAL Antidiuretic Hormone Professional Secretion Myocardial Infarction Pneumonia Aspiration Rhabdomyolysis Date:01/20/98ISR Number: 3017947-3Report Type:Expedited (15-DaCompany Report #JAUSA-31021 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Risperdal PS 5 MG 2 DAILY Initial or Prolonged Dehydration ORAL Disability Diabetes Mellitus Haldol SS 1 MG 1 DAILY Insulin-Dependent ORAL Haematochezia Klonopil C Joint Stiffness Lethargy Respiratory Failure Sepsis Date:01/26/98ISR Number: 3019308-XReport Type:Expedited (15-DaCompany Report #9800488 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Zoloft PS ORAL 50.00 MG Hospitalization - Bipolar Disorder Professional TOTAL:DAILY:O Initial or Prolonged Blood Lactate RAL Dehydrogenase Decreased Xanax SS Blood Sodium Decreased Lithium SS ORAL 900.00 MG Completed Suicide TOTAL:TID:ORA Crystalluria L Cystitis Risperidone SS ORAL 9.00 MG Depression TOTAL:TID:ORA Drug Interaction L Potentiation Cogentin C Dyskinesia Ativan C Electroencephalogram Restoril C Abnormal Haldol Decanoate C Eye Movement Disorder Haldol C Haematuria Intentional Overdose Ketonuria Nervous System Disorder Urinary Tract Infection Urine Analysis Abnormal Date:01/28/98ISR Number: 3021255-4Report Type:Expedited (15-DaCompany Report #980121-008010207 Age:82 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Dehydration Disability Lethargy 22-Feb-2006 08:20 AM Page: 16 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Occult Blood Positive Respiratory Failure Sepsis Report Source Product Role Manufacturer Route Dose Duration Health Haloperidol PS ORAL 1 MG, QD Professional Risperidone SS ORAL .5 MG QD Clonazepam C Date:01/28/98ISR Number: 3022603-1Report Type:Direct Company Report # Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Serzone PS ORAL 50MG PO BID Initial or Prolonged Megacolon Risperdal SS ORAL 2MG PO BID Date:01/28/98ISR Number: 3022744-9Report Type:Direct Company Report # Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anoxia Zyprexia PS ORAL ORAL DOSE UNK Initial or Prolonged Blood Creatine Risperidal SS ORAL ORAL DOSE UNK Phosphokinase Increased Blood Creatine Phosphokinase Mb Increased Encephalopathy Laceration Neuroleptic Malignant Syndrome Respiratory Distress White Blood Cell Count Increased Date:01/29/98ISR Number: 3106534-4Report Type:Periodic Company Report #8-97299-104K Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Consumer Redux PS ORAL 15 MG TWICE DAILY ORAL Risperdal SS ONCE DAILY Desyrel C Nitrobid C Premarin C Risperdal C Zantac C Date:01/30/98ISR Number: 3021722-3Report Type:Expedited (15-DaCompany Report #JAUSA-31160 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Consumer Risperdal PS Janssen ORAL .5 MG DAILY Convulsion ORAL; Pulmonary Embolism RECEIVED 1 DOSE Neptazane C 22-Feb-2006 08:20 AM Page: 17 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/98ISR Number: 3021723-5Report Type:Expedited (15-DaCompany Report #JAUSA-31098 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Risperdal PS Janssen ORAL 6 MG DAILY Initial or Prolonged Constipation Professional ORAL Ileus Paralytic Thyroid C Trazodone C Date:01/30/98ISR Number: 3021724-7Report Type:Expedited (15-DaCompany Report #JAUSA-31103 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Activated Partial Health Risperdal PS Janssen ORAL 1 MG, 3 Life-Threatening Thromboplastin Time Professional DAILY, ORAL Hospitalization - Prolonged Mellaril SS ORAL 50 MG 3 Initial or Prolonged Acute Respiratory DAILY, ORAL Distress Syndrome Lithium C Anorexia Depakote C Body Temperature Claritin-D C Decreased Cardiac Arrest Cardio-Respiratory Arrest Cardiogenic Shock Coordination Abnormal Disseminated Intravascular Coagulation Drug Level Above Therapeutic Drug Toxicity Gait Disturbance Lethargy Otitis Media Pancreatitis Platelet Count Decreased Pneumonia Renal Failure Renal Failure Acute Temperature Regulation Disorder Date:01/30/98ISR Number: 3021725-9Report Type:Expedited (15-DaCompany Report #JAUSA-26256 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Migraine Consumer Risperdal PS Janssen ORAL DAILY ORAL Movement Disorder Zoloft C Sedation Tenormin C Date:02/03/98ISR Number: 3022199-4Report Type:Expedited (15-DaCompany Report #001-0916-980001 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Literature Carbamazepine PS ORAL 600 MG, PER Initial or Prolonged Health ORAL Professional Risperidone SS ORAL 4 TO 8 MG/DAY PER ORAL 22-Feb-2006 08:20 AM Page: 18 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/98ISR Number: 3028915-XReport Type:Direct Company Report # Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Risperdal PS ORAL 3MG PO TID Initial or Prolonged Insomnia Benadryl C Restlessness Cogentin C Date:02/04/98ISR Number: 3027242-4Report Type:Direct Company Report # Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dystonia Risperdal PS ORAL .5-1.0MG Tardive Dyskinesia ORAL; DAILY .5-1MG 9 MOS, PM 4 MOS Lithium C Lorazepam C Synthroid C Premarin C Provera C Carbamazepine C Venlafaxine C Lamotrigine C Date:02/05/98ISR Number: 3024084-0Report Type:Expedited (15-DaCompany Report #971121-008013188 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Haldol PS ORAL UNK, UNK, Health ORAL Professional Risperidone SS ORAL UNK, UNK, ORAL Cisapride SS ORAL 10 MG, TID, ORAL Buflomedil SS ORAL 150 MG, QD, ORAL Propafenone SS 300 MG, QD, UNK Zopiclone SS ORAL 7.5 MG, UNK, ORAL Paroxetine SS ORAL 20 MG, UNK, ORAL Macrogol SS ORAL UNK, UNK, ORAL Gaviscon SS ORAL UNK, UNK, ORAL Efferalgan SS ORAL UNK, UNK, ORAL Date:02/05/98ISR Number: 3024471-0Report Type:Direct Company Report # Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperidone PS ORAL 1 MG PO Q 8 Psychomotor Hyperactivity Professional HR Percocet C 22-Feb-2006 08:20 AM Page: 19 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/98ISR Number: 3026289-1Report Type:Expedited (15-DaCompany Report #JAFRA-37077 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal PS Janssen ORAL 2 MG DAILY Initial or Prolonged Phosphokinase Increased Health ORAL Chromaturia Professional Tercian SS ORAL 25 MG DAILY Myalgia ORAL Myoglobinuria Coversyl C Pyrexia Renal Impairment Rhabdomyolysis Date:02/09/98ISR Number: 3026291-XReport Type:Expedited (15-DaCompany Report #JABEL-37444 Age:20 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Risperidone PS Janssen ORAL ORAL 2 WK Hypervigilance Health Haloperidol C Professional Date:02/09/98ISR Number: 3026294-5Report Type:Expedited (15-DaCompany Report #JAFRA-36322 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Risperdal PS Janssen ORAL .75 MG 2 Anxiety Health DAILY ORAL Blood Pressure Professional Dipiperon Solution SS Janseen ORAL 3 DAILY Fluctuation ORAL;20 DROPS Cardio-Respiratory Arrest TID Circulatory Collapse Seresta C Depression Stilnox C Drug Ineffective Voltarene C Hyperhidrosis Anafranil C Hypertensive Crisis Equinil C Malaise Floxyfral C Suicidal Ideation Dogmatil C Tercian C Date:02/09/98ISR Number: 3026297-0Report Type:Expedited (15-DaCompany Report #JAFRA-37447 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Risperdal PS Janssen ORAL ORAL Health Professional Date:02/09/98ISR Number: 3026299-4Report Type:Expedited (15-DaCompany Report #JAKYO-33837 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal PS Janssen ORAL 2 MG DAILY Health ORAL Professional Haloperidol C Levomepromazine C Flunitrazepam C Voglibose C Benefibrate C 22-Feb-2006 08:20 AM Page: 20 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insulin C Etizolam C Date:02/09/98ISR Number: 3026303-3Report Type:Expedited (15-DaCompany Report #JAKYO-37064 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Risperdal PS Janssen ORAL 6 MG DAILY Phosphokinase Increased Health ORAL Chromaturia Professional Haloperidol SS Janssen ORAL 6 MG DAILY Condition Aggravated ORAL Hallucination, Auditory Flunitrazepam C Hepatic Necrosis Diazepam C Myalgia Biperiden Pain In Extremity Hydrochloride C Renal Impairment Rhabdomyolysis Date:02/09/98ISR Number: 3026306-9Report Type:Expedited (15-DaCompany Report #JAFRA-36319 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Foreign Risperdal PS Janssen ORAL 1 MG DAILY Life-Threatening Aggression Health ORAL Cerebrovascular Accident Professional Dipiperon SS Janssen ORAL 20 MG 2 DAILY Condition Aggravated ORAL Delirium Hypertensive Crisis Loss Of Consciousness Malaise Date:02/09/98ISR Number: 3026314-8Report Type:Expedited (15-DaCompany Report #JACAN-16535 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Risperdal PS Janssen ORAL 2.5 MG DAILY Exposure To Therapeutic Health ORAL Drugs Professional Paxil SS ORAL 20 MG DAILY Oligohydramnios ORAL Premature Baby Umbilical Cord Prolapse Date:02/09/98ISR Number: 3026319-7Report Type:Expedited (15-DaCompany Report #JAUK-36278 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Haemolytic Foreign Risperdal PS Janssen ORAL 6 MG DAILY Initial or Prolonged Autoimmune Health ORAL Antinuclear Antibody Professional Depixol SS INTRAMUSCULAR 40 MG 1 Antinuclear Antibody WEEKLY Positive INTRAMUSCULAR Dyspnoea Raynaud'S Phenomenon Renal Impairment Systemic Lupus Erythematosus 22-Feb-2006 08:20 AM Page: 21 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/98ISR Number: 3029667-XReport Type:Expedited (15-DaCompany Report #HOAFF-32016 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Risperidone PS ORAL 228 MG SINGLE Initial or Prolonged Blood Lactate Literature Dehydrogenase Increased Health Depression Professional Hallucination Overdose Tearfulness Date:02/11/98ISR Number: 3029672-3Report Type:Expedited (15-DaCompany Report #JAGER-37304 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Foreign Risperdal PS ORAL 1 MG DAILY Initial or Prolonged Hallucination, Visual Health Tregor C Oedema Professional Akineton Retard C Speech Disorder Madopar C Date:02/13/98ISR Number: 3030108-7Report Type:Expedited (15-DaCompany Report #JACAN-16617 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Risperdal PS Janssen ORAL 1 MG 1 DAILY Initial or Prolonged Depression ORAL; 1 MG 2 Drug Withdrawal Syndrome DAILY ORAL; 1 Dyspnoea MG 4 DAILY Fall ORAL Fluid Overload Levothyroxine C Mania Asa Enteric Coated C Pulmonary Congestion Colace C Pulmonary Oedema Milk Of Magnesia C Weight Increased Cascara C Temazepam C Paxil C Date:02/13/98ISR Number: 3030116-6Report Type:Expedited (15-DaCompany Report #JAFRA-36387 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Risperdal PS Janssen ORAL .75MG 2 DAILY Initial or Prolonged Aspergilloma Health ORAL Cyanosis Professional Dipiperon SS Janssen ORAL 20 DROPS Dyspnoea DAILY (IN TWO Electrocardiogram St TIMES) ORAL Segment Abnormal Theostat SS ORAL ORAL Fall Bricanyl SS ORAL TABLET 2.5 MG Heart Rate Irregular ORAL Hypothyroidism Raniplex SS ORAL ORAL TABLET Malaise Cordarone SS ORAL TABLET 200MG Pallor ORAL Productive Cough Dogmatil SS ORAL 100 MG DAILY Respiratory Failure ORAL Superinfection Aldactazine SS ORAL 1/2 TABLET Tuberculosis ALT DAY ORAL Digoxine C Rocephine C 22-Feb-2006 08:20 AM Page: 22 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mucomyst C Prozac C Date:02/13/98ISR Number: 3030121-XReport Type:Expedited (15-DaCompany Report #JAUSA-31021 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Risperdal PS Janssen ORAL .5 MG 2 DAILY Initial or Prolonged Dehydration ORAL Disability Diabetes Mellitus Haldol SS Janssen ORAL 1 MG 1 DAILY Insulin-Dependent ORAL Joint Stiffness Klonopin C Lethargy Respiratory Failure Sepsis Date:02/13/98ISR Number: 3030126-9Report Type:Expedited (15-DaCompany Report #JAUK-36278 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Haemolytic Foreign Risperdal PS Janssen ORAL 6 MG DIALY Initial or Prolonged Autoimmune Health ORAL TABLET; Dyspnoea Professional COMMENTS: Fatigue USED FOR MORE Proteinuria THAN 3 Raynaud'S Phenomenon Depixol SS INTRAMUSCULAR 40 MG 1 Renal Impairment WEEKLY Systemic Lupus INTRAMUSCULAR Erythematosus ; COMMENTS: USED FOR MORE Chlorpromazine C Kemadrin C Date:02/17/98ISR Number: 3030480-8Report Type:Expedited (15-DaCompany Report #JAFRA-37598 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrooesophageal Reflux Foreign Risperdal PS ORAL 2 MG DAILY Disease ORAL Impaired Gastric Emptying Rohypnol SS ORAL I MG 1 DAILY Medication Error ORAL Nozinan SS ORAL 50 MG DAILY ORAL 27 MON Date:02/17/98ISR Number: 3030481-XReport Type:Expedited (15-DaCompany Report #JAUSA-30301 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalopathy Health Risperdal PS ORAL Initial or Prolonged Professional 22-Feb-2006 08:20 AM Page: 23 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/98ISR Number: 3030482-1Report Type:Expedited (15-DaCompany Report #JAUSA-29879 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Risperdal PS ORAL 6 MG DAILY Phosphokinase Increased Professional Buspar C Myalgia Lithium C Rhabdomyolysis Paxil C Cogentin C Klonopin C Date:02/17/98ISR Number: 3030608-XReport Type:Direct Company Report # Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Risperidone PS Confusional State Clonidine C Tremor Lithium C Verapamil C Divalproex C Fluoxetine C Date:02/17/98ISR Number: 3030638-8Report Type:Direct Company Report # Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Health Risperdal PS ORAL 0.5 MG PO HS Initial or Prolonged Diverticulitis Professional STOP DATE Neutropenia 2/3/98 , 1 White Blood Cell Count MG PO BID Decreased THERAPY DATES Buspar SS Bristol Myers 10 MG PO BID Ecotrin C Cimetidine C Diltiazem C Diphenhydramine C Paxil C Verapamil C Hycodan C Date:02/18/98ISR Number: 3036408-9Report Type:Direct Company Report # Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothermia Risperdal PS Janssen ORAL 0.5 MG PO BID Aspirin C Depakote C Pepsid C Isordil C Levothyroxine C Mvi C Risperdal C Sorbitol C Ativan C 22-Feb-2006 08:20 AM Page: 24 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/98ISR Number: 3032445-9Report Type:Expedited (15-DaCompany Report #JAFIN-37709 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Foreign Risperdal PS ORAL 2 MG DAILY Initial or Prolonged Decreased Study ORAL Health Olanzapine SS ORAL 2 MG DAILY Professional ORAL Date:02/19/98ISR Number: 3032449-6Report Type:Expedited (15-DaCompany Report #JAFRA-37077 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal PS Janssen Research Initial or Prolonged Phosphokinase Increased Health Foundation ORAL ORAL Disability Chromaturia Professional Tercian SS ORAL 25 MG DAILY Myalgia ORAL Myoglobinuria Coversyl C Pyrexia Prozac C Renal Impairment Stilnox C Rhabdomyolysis Date:02/19/98ISR Number: 3032453-8Report Type:Expedited (15-DaCompany Report #JAFRA-36387 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Risperdal PS Janssen Research Initial or Prolonged Aspergilloma Health Foundation ORAL .75 MG 2 Cyanosis Professional DAILY ORAL Dyspnoea Dipiperon SS Janssen Research Electrocardiogram St Foundation ORAL ORAL Segment Abnormal Bricanyl SS ORAL 2.5 MG ORAL Fall Cordarone SS ORAL 200 MG ORAL Heart Rate Irregular Theostat SS ORAL ORAL Hypothyroidism Dogmatil SS ORAL 100 MG DAILY Leukocytosis ORAL Malaise Aldactazine SS ORAL 1/2 TABLET Pallor ORAL ALT DAY Productive Cough Digoxine C Respiratory Failure Rocephine C Superinfection Prozac C Tuberculosis Raniplex C ORAL ORAL Mucomyst C Date:02/23/98ISR Number: 3034736-4Report Type:Expedited (15-DaCompany Report #JAUSA-31565 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sepsis Health Risperdal PS Janssen ORAL 2 Initial or Prolonged Professional MG/2DAILY/ORA L Depakote C Artane C Monopril C Adalate C Lithium C 22-Feb-2006 08:20 AM Page: 25 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/98ISR Number: 3034772-8Report Type:Expedited (15-DaCompany Report #JAUSA-31103 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Activated Partial Health Risperdal PS Janssen ORAL 1 MG 3 DAILY Life-Threatening Thromboplastin Time Professional ORAL Hospitalization - Prolonged Mellaril SS ORAL 50 MG 3 DAILY Initial or Prolonged Acute Respiratory ORAL Distress Syndrome Lithium C Anorexia Depakote C Blood Potassium Decreased Claritin-D C Blood Sodium Decreased Amoxicillin C Body Temperature Cefzil C Decreased Cardio-Respiratory Arrest Cardiogenic Shock Coordination Abnormal Disseminated Intravascular Coagulation Gait Disturbance Heart Rate Increased Lethargy Otitis Media Platelet Count Decreased Pneumonia Renal Failure Respiratory Rate Increased Sepsis Stupor Therapeutic Agent Toxicity Date:02/25/98ISR Number: 3212691-1Report Type:Periodic Company Report #JAUSA-33746 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Risperdal PS Janssen ORAL SEE IMAGE Klonopin C Date:02/25/98ISR Number: 3213238-6Report Type:Periodic Company Report #JAUSA-32473 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nervousness Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY Palpitations ORAL Lithium C Alcohol C Ativan C Date:02/25/98ISR Number: 3213278-7Report Type:Periodic Company Report #JAUSA-32531 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Professional ORAL Dilantin C Adderall C Imipramine C 22-Feb-2006 08:20 AM Page: 26 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/26/98ISR Number: 3039793-7Report Type:Direct Company Report # Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Zyprexa PS ORAL 7.5 MG PO QHS Congestive Risperidol SS Depressed Level Of Consciousness Leukocytosis Muscle Rigidity Myalgia Neuroleptic Malignant Syndrome Pyrexia Respiratory Failure Sepsis Tremor Date:02/26/98ISR Number: 3088079-3Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Risperdal PS 1MG BID Date:02/27/98ISR Number: 3041744-6Report Type:Direct Company Report # Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Joint Stiffness Risperidone PS Janssen ORAL 1 MG BID Parkinson'S Disease Date:02/27/98ISR Number: 3041978-0Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Risperdal Liquid PS ORAL 3 MG BID Professional Date:02/27/98ISR Number: 3042823-XReport Type:Direct Company Report # Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Heart Rate Increased Risperdal PS Janssen 2 MG HS AND 1 Intervention to Tremor MG BID Prevent Permanent Benztropine C 1 MG Impairment/Damage Synthroid C Zoloft C Lorazepam C Date:02/27/98ISR Number: 3043692-4Report Type:Direct Company Report # Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Risperidone PS ORAL 2 MG QAM ORAL, 2MG BID ORAL Carbamazepine C 22-Feb-2006 08:20 AM Page: 27 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Perphenazine C Trazodone C Date:03/02/98ISR Number: 3034770-4Report Type:Expedited (15-DaCompany Report #JAFRA-37782 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal PS Janssen ORAL 1 MG/1DAILY Health ORAL Professional Tercian C Tranxene C Praxilene C Zyloric C Xatral C Torental C Pindione C Laroxyl C Date:03/02/98ISR Number: 3039641-5Report Type:Expedited (15-DaCompany Report #JACAN-16646 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Crohn'S Disease Foreign Risperdal PS Janssen ORAL DAILY, ORAL; Rectal Haemorrhage Health TX TIMES: 1) Professional UNKNOWN DOSE; 2) 1.5 MG; 3) 2 MG Date:03/02/98ISR Number: 3039643-9Report Type:Expedited (15-DaCompany Report #JAFRA-35572 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chorea Foreign Risperdal PS Janssen ORAL 2 MG 1 DAILY Hospitalization - Confusional State Health ORAL; 4MG Initial or Prolonged Pain Professional DAILY 2MG DAILY 53 WKY Risperdal SS ORAL 2, 4 MG 1 DAILY ORAL 23 WK Date:03/02/98ISR Number: 3039645-2Report Type:Expedited (15-DaCompany Report #JAFRA-37851 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Foreign Risperdal PS Janssen ORAL 4 MG DAILY Headache Health ORAL Professional Xanax C Prozac C Stilnox C Date:03/02/98ISR Number: 3039647-6Report Type:Expedited (15-DaCompany Report #JAGER-37304 Age:87 YR Gender:Female I/FU:F Outcome Death Life-Threatening Hospitalization - 22-Feb-2006 08:20 AM Page: 28 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Foreign Risperdal PS Janssen ORAL 1 MG DAILY Dementia Health ORAL TAB Hallucination, Auditory Professional Tregor C Hallucination, Visual Akineton Retard C Oedema Madopar C Speech Disorder Date:03/02/98ISR Number: 3039648-8Report Type:Expedited (15-DaCompany Report #JAFIN-37709 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutrophil Count Foreign Risperdal PS Janssen ORAL 2 MG DAILY Initial or Prolonged Decreased Study ORAL Health Olanzapine SS ORAL 2 MG DAILY Professional ORAL Flixonase C Duact C Tenox C Date:03/02/98ISR Number: 3129684-5Report Type:Periodic Company Report #JAUSA-26350 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal PS Janssen ORAL .5 MG 1 DAILY Initial or Prolonged Dyspnoea Professional ORAL-1 MG 1 Hypoxia DAILY ORAL- 1.5 MG 1 DAILY ORAL 1 WK Date:03/02/98ISR Number: 3133220-7Report Type:Periodic Company Report #9624546 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depersonalisation Consumer Zoloft PS ORAL 50.00 MG TOTAL: DAILY: ORAL Risperdal SS ORAL ORAL Capoten C Diabinese C Date:03/02/98ISR Number: 3144794-4Report Type:Periodic Company Report #9726880 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Consumer Zoloft PS ORAL ORAL Xanax SS Risperdal SS Ritalin C 22-Feb-2006 08:20 AM Page: 29 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/98ISR Number: 3145136-0Report Type:Periodic Company Report #9722554 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Zoloft Tablets PS ORAL 50 MG TOTAL: Headache DAILY: ORAL Pain Risperdal SS ORAL 1.00 MG TOTAL: DAILY: ORAL Verapamil C Date:03/02/98ISR Number: 3149776-4Report Type:Periodic Company Report #9709592 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Zoloft PS ORAL 25 MG TOTAL Gait Disturbance Professional DAILY ORAL Tremor Risperdal SS Desyrel C Cogentin C Date:03/03/98ISR Number: 3049911-2Report Type:Direct Company Report # Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Clomipramine PS 175 MG Q HS Gaze Palsy Professional Risperidone SS 0.5 MG BID Muscle Twitching Vision Blurred Vomiting Date:03/03/98ISR Number: 3049923-9Report Type:Direct Company Report # Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Parkinson'S Disease Risperidal PS 0.5 BID Intervention to ? C Prevent Permanent Impairment/Damage Date:03/03/98ISR Number: 3142896-XReport Type:Periodic Company Report #JAUSA-31272 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Propulsid PS Janssen ORAL 10 MG 3 DAILY Atrial Fibrillation Professional ORAL Coagulation Time Risperdal SS Janssen ORAL 5 MG 1 DAILY Prolonged ORAL Drug Interaction Coumadin SS Insulin (Insulin, Unspec) C 22-Feb-2006 08:20 AM Page: 30 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/98ISR Number: 3040385-4Report Type:Expedited (15-DaCompany Report #980109-008010040 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chromaturia Foreign Haloperidol Initial or Prolonged Myalgia Health Decanoate PS INTRAMUSCULAR 100MG, Pain In Extremity Professional 1X/MO,IM Rhabdomyolysis (INTRAMUSCULA R) Risperidone SS ORAL 6MG, QD, ORAL Biperiden Hydrochloride C Flunitrazepam C Diazepam C Date:03/05/98ISR Number: 3050058-XReport Type:Direct Company Report # Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Risperdal PS ORAL 2MG PO BID; Hospitalization - Consciousness APPROX 2 Initial or Prolonged Malabsorption WEEKS PRIOR Muscle Rigidity TO ADMISSION 2 WK Pain Buspar C Pyrexia Dilantin C Artane C Macrodantin C Date:03/06/98ISR Number: 3131452-5Report Type:Periodic Company Report #8-97343-016H Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Effexor PS ORAL 225 MG ONCE Muscle Rigidity Professional DAILY Risperdal SS 1 MG DAILY Cogentin C Date:03/06/98ISR Number: 3137900-9Report Type:Periodic Company Report #8-97258-013T Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperpituitarism Health Effexor PS ORAL 187.5 & 225 Professional MG DAILY ORAL Risperdal SS Tegretol C Date:03/06/98ISR Number: 3145214-6Report Type:Periodic Company Report #8-97192-007L Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ecchymosis Health Effexor PS ORAL 112.5 MG Thrombocytopenia Professional TWICE DAILY ORAL Risperdal SS Risperdal C 22-Feb-2006 08:20 AM Page: 31 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/98ISR Number: 3145270-5Report Type:Periodic Company Report #8-97195-005L Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Effexor PS ORAL <150MG TWICE Syncope DAILY ORAL Weight Increased ,150MG TWICE DAILY Alcohol Unspecified SS UNKNOWN UNK Risperdal SS UNKNOWN UNK Depakote C Date:03/11/98ISR Number: 3055955-7Report Type:Expedited (15-DaCompany Report #8-98063-009D Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Parkinane PS ORAL 2 MG ONCE Initial or Prolonged Dehydration Health DAILY ORAL Other Disorientation Professional Depamide SS ORAL 300 MG DAILY Hyperthermia Malignant ORAL Pyrexia Mepronizine SS ORAL ORAL Risperdal SS 2 MG DAILY (UNTIL 11/26), 1MG DAILY Rohypnol SS ORAL 1 MG DAILY ORAL Date:03/12/98ISR Number: 3124985-9Report Type:Periodic Company Report #JAUSA-30537 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Risperdal PS Janssen ORAL .25 MG 1 Fatigue Professional DAILY ORAL Gait Disturbance Aricept SS ORAL 5 MG 1 DAILY Tremor ORAL Potassium C Aspirin C Desyrel C Date:03/12/98ISR Number: 3124988-4Report Type:Periodic Company Report #JAUSA-30538 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactoid Reaction Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3124989-6Report Type:Periodic Company Report #JAUSA-30539 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Consumer Risperdal PS Janssen ORAL 4 MG 2 DAILY ORAL Doxepin C 22-Feb-2006 08:20 AM Page: 32 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3124990-2Report Type:Periodic Company Report #JAUSA-30541 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 4 MG 2 DAILY Dermatitis Professional ORAL Depakote C Imipramine C Procardia C Date:03/12/98ISR Number: 3124991-4Report Type:Periodic Company Report #JAUSA-30551 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 2 MG DAILY Oedema Professional ORAL Cytomel C Diuretics C Date:03/12/98ISR Number: 3124992-6Report Type:Periodic Company Report #JAUSA-30562 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal PS ORAL 1 MG 2 DAILY Initial or Prolonged Syndrome Professional ORAL, 2 MG 2 DAILY, 3 MG SINGLE 4 DAY Paxil C Depakote C Congentin C Date:03/12/98ISR Number: 3124993-8Report Type:Periodic Company Report #JAUSA-30592 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL 4 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3124994-XReport Type:Periodic Company Report #JAUSA-30593 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Risperdal PS Janssen ORAL 2 MG DAILY Dysphagia Professional ORAL Dyspnoea Luvox SS Tachycardia Date:03/12/98ISR Number: 3124995-1Report Type:Periodic Company Report #JAUSA-30594 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Consumer Risperdal PS Janssen ORAL 8 MG DAILY ORAL Zyprexa C Depakote C Milk Of Magnesia C 22-Feb-2006 08:20 AM Page: 33 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3124996-3Report Type:Periodic Company Report #JAUSA-30595 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Jaundice Health Risperdal PS Janssen ORAL 8 MG DAILY Professional ORAL Elavil C Date:03/12/98ISR Number: 3124997-5Report Type:Periodic Company Report #JAUSA-30612 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Consumer Risperdal PS Janssen ORAL 1 MG 3 DAILY Deficit/Hyperactivity ORAL Disorder Tegretol C Convulsion Date:03/12/98ISR Number: 3124998-7Report Type:Periodic Company Report #JAUSA-30617 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Oedema Health Risperdal PS Janssen ORAL 2 MG 2 DAILY Initial or Prolonged Suicide Attempt Professional ORAL Tachycardia Effexor C Therapeutic Response Valium C Increased Date:03/12/98ISR Number: 3124999-9Report Type:Periodic Company Report #JAUSA-30631 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL 1 MG ORAL Professional Date:03/12/98ISR Number: 3125000-3Report Type:Periodic Company Report #JAUSA-30647 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intracranial Pressure Health Risperdal PS Janssen ORAL 8 MG DAILY Increased Professional ORAL Date:03/12/98ISR Number: 3125001-5Report Type:Periodic Company Report #JAUSA-30659 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3125002-7Report Type:Periodic Company Report #JAUSA-30660 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal PS Janssen ORAL ORAL Professional 22-Feb-2006 08:20 AM Page: 34 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3125003-9Report Type:Periodic Company Report #JAUSA-30661 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Professional ORAL Prozac C Date:03/12/98ISR Number: 3125004-0Report Type:Periodic Company Report #JAUSA-30662 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diverticulitis Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3125005-2Report Type:Periodic Company Report #JAUSA-30664 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL 4 MG 2 DAILY Hyperprolactinaemia Professional ORAL Prozac C Date:03/12/98ISR Number: 3125006-4Report Type:Periodic Company Report #JAUSA-30665 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL ORAL Mania Professional Date:03/12/98ISR Number: 3125007-6Report Type:Periodic Company Report #JAUSA-30757 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Consumer Risperdal Headache (Risperidone) PS Janssen ORAL 1 MG 2 DAILY Hypertension ORAL Tachycardia Ritalin C Keflex C Date:03/12/98ISR Number: 3125008-8Report Type:Periodic Company Report #JAUSA-30758 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Risperdal Initial or Prolonged Professional (Risperidone) PS Janssen ORAL 2 MG 3 DAILY ORAL Cogentin C Fosamax C Prempro C Desyrel C Multivitamins C Laxative Unspec C 22-Feb-2006 08:20 AM Page: 35 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3125009-XReport Type:Periodic Company Report #JAUSA-30759 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Risperdal Agitation (Risperidone) PS Janssen ORAL 1 MG DAILY Arthritis ORAL Breast Neoplasm Oral Contracept C Depression Laboratory Test Abnormal Weight Decreased Date:03/12/98ISR Number: 3125010-6Report Type:Periodic Company Report #JAUSA-30761 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bruxism Consumer Risperdal Dyskinesia (Risperidone) PS Janssen ORAL .5 MG DAILY Speech Disorder ORAL Paxil C Buspar C Klonopin C Date:03/12/98ISR Number: 3125012-XReport Type:Periodic Company Report #JAUSA-30764 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal Initial or Prolonged Sedation (Risperidone) PS Janssen ORAL 4.5 MG DAILY ORAL; 3 MG 3 DAILY Clozaril C Date:03/12/98ISR Number: 3125014-3Report Type:Periodic Company Report #JAUSA-30765 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3125015-5Report Type:Periodic Company Report #JAUSA-30769 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urine Abnormality Consumer Risperdal (Risperidone) PS Janssen ORAL 3 MG 1 DAILY ORAL Benzodiazepines SS Depakote C Date:03/12/98ISR Number: 3125017-9Report Type:Periodic Company Report #JAUSA-30771 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cough Consumer Risperdal Dermatitis (Risperidone) PS Janssen ORAL 6 MG DAILY 22-Feb-2006 08:20 AM Page: 36 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Robitussin (Guaifenesine) SS ORAL -, 2 DAILY ORAL Mellaril C Date:03/12/98ISR Number: 3125018-0Report Type:Periodic Company Report #JAUSA-30774 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Hyperhidrosis (Risperidone) PS Janssen ORAL 3 MG 2 DAILY Thinking Abnormal ORAL Tremor Synthroid C Weight Increased Date:03/12/98ISR Number: 3125019-2Report Type:Periodic Company Report #JAUSA-30776 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psoriasis Health Risperdal Professional (Risperidone) PS Janssen ORAL 1.5 MG DAILY ORAL Date:03/12/98ISR Number: 3125021-0Report Type:Periodic Company Report #JAUSA-30794 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Risperdal Initial or Prolonged Drug Interaction Professional (Risperidone) PS Janssen ORAL -, ORAL Prothrombin Level Coumadin C Increased Date:03/12/98ISR Number: 3125022-2Report Type:Periodic Company Report #JAUSA-30796 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3125024-6Report Type:Periodic Company Report #JAUSA-30797 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Weight Increased Professional (Risperidone) PS Janssen ORAL 2 MG 2 DAILY ORAL Prozac C Lithium C Depakote C 22-Feb-2006 08:20 AM Page: 37 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3125026-XReport Type:Periodic Company Report #JAUSA-30799 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Paraesthesia Professional (Risperidone) PS Janssen ORAL -, ORAL Date:03/12/98ISR Number: 3125028-3Report Type:Periodic Company Report #JAUSA-30802 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Consumer Risperdal Deficit/Hyperactivity (Risperidone) PS Janssen ORAL 3 MG 2 DAILY Disorder ORAL Navane C Lithium C Anafranil C Xanax C Mellaril C Date:03/12/98ISR Number: 3125029-5Report Type:Periodic Company Report #JAUSA-30803 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Libido Decreased Professional (Risperidone) PS Janssen ORAL 1.5 MG DAILY ORAL Date:03/12/98ISR Number: 3125031-3Report Type:Periodic Company Report #JAUSA-30805 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Health Risperdal Professional (Risperidone) PS Janssen ORAL 2.5 MG DAILY ORAL; .5 MG DAILY Date:03/12/98ISR Number: 3125032-5Report Type:Periodic Company Report #JAUSA-30807 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Risperdal Nervousness Professional (Risperidone) PS Janseen ORAL 1 MG DAILY ORAL; .5 MG DAILY; .25 MG DAILY Depakote C Effexor C Date:03/12/98ISR Number: 3125034-9Report Type:Periodic Company Report #JAUSA-30811 Age:36 YR Gender:Female I/FU:I Outcome PT Hospitalization - Hallucination Initial or Prolonged Hallucination, Visual Medication Error Paranoia 22-Feb-2006 08:20 AM Page: 38 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Schizophrenia Tremor Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal (Risperidone) PS Janssen ORAL 3 MG DAILY ORAL Ultram C Vistaril C Inderal C Trazodone C Date:03/12/98ISR Number: 3125035-0Report Type:Periodic Company Report #JAUSA-30829 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 1.5 MG DAILY ORAL Date:03/12/98ISR Number: 3125037-4Report Type:Periodic Company Report #JAUSA-30729 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Risperdal PS Jannsen ORAL .5 MG 2 DAILY Anxiety ORAL-1 MG 2 Back Pain DAILY ORAL Chest Pain Tegretol C Cough Ativan C Dermatitis Benadryl C Dysphagia Sudafed C Dyspnoea Oedema Pruritus Rhinitis Tremor Date:03/12/98ISR Number: 3125038-6Report Type:Periodic Company Report #JAUSA-30730 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Consumer Risperdal PS Janssen ORAL 2 MG DAILY Libido Decreased ORAL-6 MG DAILY ORAL Zoloft C Lithium C Date:03/12/98ISR Number: 3125040-4Report Type:Periodic Company Report #JAUSA-30732 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY Initial or Prolonged Psychotic Disorder ORAL-8 MG DAILY ORAL Mellaril C Depakote C Klonopin C Cozaar C 22-Feb-2006 08:20 AM Page: 39 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report K-Dur C Glucosamine Sulfate C Demadex C Glucosamine C Date:03/12/98ISR Number: 3125042-8Report Type:Periodic Company Report #JAUSA-30734 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neurosis Health Risperdal PS Janssen ORAL .5 MG 1 DAILY Professional ORAL Adderall C Date:03/12/98ISR Number: 3125045-3Report Type:Periodic Company Report #JAUSA-30736 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Consumer Risperdal PS Janssen ORAL 1 MG 2 DAILY Ejaculation Disorder ORAL-3 MG Tachycardia DAILY ORAL 26 DAY Date:03/12/98ISR Number: 3125046-5Report Type:Periodic Company Report #JAUSA-30737 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal PS Janssen ORAL 3 MG DAILY Dysphagia ORAL-2 MG IN Hyperprolactinaemia AM, 1 MG HS Benadryl C Vitamin E C Amantadine C Cogentin C Date:03/12/98ISR Number: 3125047-7Report Type:Periodic Company Report #JAUSA-30738 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal PS Janssen ORAL 2 MG DAILY ORAL Zoloft C Fenfluramine C Date:03/12/98ISR Number: 3125049-0Report Type:Periodic Company Report #JAUSA-30740 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Libido Decreased Risperdal PS Janssen ORAL 2 MG 2 DAILY Vulval Disorder ORAL-3 MG DAILY-2 MG DAILY-1 MG DAILY ORAL 11 MON Imipramine C 22-Feb-2006 08:20 AM Page: 40 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3125050-7Report Type:Periodic Company Report #JAUSA-30743 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal PS Janssen ORAL 3 MG 1 DAILY Disturbance In Attention ORAL-2 MG Dystonia DAILY ORAL- 1 Sedation MG DAILY ORAL 20 DAY Speech Disorder Ativan C Urinary Incontinence Cogentin C Date:03/12/98ISR Number: 3125052-0Report Type:Periodic Company Report #JAUSA-30744 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal PS Janssen ORAL 6 MG DAILY Professional ORAL- 3 MG DAILY ORAL Paxil C Date:03/12/98ISR Number: 3125053-2Report Type:Periodic Company Report #JAUSA-30746 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Risperdal PS Janssen ORAL 1 MG DAILY Professional ORAL Cogentin C Ativan C Multivitamins C Date:03/12/98ISR Number: 3125054-4Report Type:Periodic Company Report #JAUSA-30747 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Risperdal PS Janssen ORAL 2 MG 2 DAILY Professional ORAL Cogentin C Eskalith C Date:03/12/98ISR Number: 3125057-XReport Type:Periodic Company Report #JAUSA-30748 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Consumer Risperdal PS Janssen ORAL 1 MG 3 DAILY Oedema ORAL Orap C Luvox C Klonopin C Date:03/12/98ISR Number: 3125059-3Report Type:Periodic Company Report #JAUSA-30749 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Professional ORAL Lopressor C 22-Feb-2006 08:20 AM Page: 41 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3125060-XReport Type:Periodic Company Report #JAUSA-30751 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY Anxiety ORAL-3 MG IN Hypothermia AM 3 MG IN PM Lithium C Date:03/12/98ISR Number: 3125061-1Report Type:Periodic Company Report #JAUSA-30752 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Professional ORAL Aricept C Date:03/12/98ISR Number: 3125063-5Report Type:Periodic Company Report #JAUSA-30753 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Consumer Risperdal PS Janssen ORAL 3 MG DAILY Tremor ORAL Clonidine C Advil C Date:03/12/98ISR Number: 3125065-9Report Type:Periodic Company Report #JAUSA-30754 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY Hyperprolactinaemia ORAL- 3 MG 3 DAILY ORAL 2 WK Date:03/12/98ISR Number: 3125066-0Report Type:Periodic Company Report #JAUSA-30755 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY Deficit/Hyperactivity ORAL Disorder Mellaril SS 400 MG DAILY- TAPERED DOWN BY 50 MG OVER EIGHT DAYS Navane C Lithium C Anafranil C Xanax C Date:03/12/98ISR Number: 3125068-4Report Type:Periodic Company Report #JAUSA-30756 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Professional ORAL 22-Feb-2006 08:20 AM Page: 42 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3125070-2Report Type:Periodic Company Report #JAUSA-30666 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Health Risperdal PS Janssen ORAL TABLET, ORAL Professional Date:03/12/98ISR Number: 3125072-6Report Type:Periodic Company Report #JAUSA-30667 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Risperdal PS Janssen ORAL TABLET, ORAL Professional Date:03/12/98ISR Number: 3125074-XReport Type:Periodic Company Report #JAUSA-30668 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Risperdal PS Janssen ORAL TABLET, ORAL Face Oedema Professional Claritin-D C Synthroid C Nortriptyline C Lithium C Depakote C Date:03/12/98ISR Number: 3125075-1Report Type:Periodic Company Report #JAUSA-30687 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal PS Jansen ORAL TABLET, 2 MG Decreased Professional 2 DAILY ORAL Haldol C Vitamin E C Date:03/12/98ISR Number: 3125077-5Report Type:Periodic Company Report #JAUSA-30689 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal PS Janssen ORAL 2 MG 2 DAILY Decreased Professional ORAL Cogentin C Ativan C Date:03/12/98ISR Number: 3125079-9Report Type:Periodic Company Report #JAUSA-30698 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal PS Janssen ORAL TABLET, ORAL Professional Date:03/12/98ISR Number: 3125081-7Report Type:Periodic Company Report #JAUSA-30699 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal PS Janssen ORAL SEE IMAGE Decreased Professional Klonopin C 22-Feb-2006 08:20 AM Page: 43 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3125083-0Report Type:Periodic Company Report #JAUSA-30702 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3125085-4Report Type:Periodic Company Report #JAUSA-30705 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Orthostatic Hypotension Health Risperdal PS Janssen ORAL TABLET, ORAL Professional Date:03/12/98ISR Number: 3125087-8Report Type:Periodic Company Report #JAUSA-30710 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL SEE IMAGE Hyperprolactinaemia Professional Date:03/12/98ISR Number: 3125089-1Report Type:Periodic Company Report #JAUSA-30712 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Risperdal PS Janssen ORAL SEE IMAGE Initial or Prolonged Pancreatitis Professional Date:03/12/98ISR Number: 3125091-XReport Type:Periodic Company Report #JAUSA-30713 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Professional ORAL Date:03/12/98ISR Number: 3125093-3Report Type:Periodic Company Report #JAUSA-30714 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal PS Janssen ORAL TABLET, ORAL Professional Paxil C Date:03/12/98ISR Number: 3125095-7Report Type:Periodic Company Report #JAUSA-30716 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Professional ORAL Depakote C Adderall C 22-Feb-2006 08:20 AM Page: 44 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3125097-0Report Type:Periodic Company Report #JAUSA-30717 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Health Risperdal PS Janssen ORAL SEE IMAGE Professional Date:03/12/98ISR Number: 3125099-4Report Type:Periodic Company Report #JAUSA-30719 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Skin Discolouration Health Risperdal PS Janssen ORAL 2 MG DAILY Professional ORAL 1 WK Depakote C Navane C Paxil C Date:03/12/98ISR Number: 3125101-XReport Type:Periodic Company Report #JAUSA-30721 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Consumer Risperdal PS Janssen ORAL .5 MG 2 DAILY Involuntary ORAL Minocycline C Date:03/12/98ISR Number: 3125103-3Report Type:Periodic Company Report #JAUSA-30722 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal PS Janssen ORAL SEE IMAGE Professional Paxil C Date:03/12/98ISR Number: 3125104-5Report Type:Periodic Company Report #JAUSA-30725 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Health Risperdal PS Jansen ORAL SEE IMAGE Pruritus Professional Rash Erythematous Tremor Urinary Retention Weight Increased Date:03/12/98ISR Number: 3125106-9Report Type:Periodic Company Report #JAUSA-30728 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperacusis Consumer Risperdal PS Janssen ORAL SEE IMAGE Nausea Lithium C Vomiting 22-Feb-2006 08:20 AM Page: 45 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3127090-0Report Type:Periodic Company Report #JAUSA-30929 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Risperdal Phosphokinase Increased Professional (Risperidone) PS Janssen ORAL 1 MG ORAL Leukopenia Pamelor Weight Increased (Nortriptyline) C Date:03/12/98ISR Number: 3127093-6Report Type:Periodic Company Report #JAUSA-30930 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Health Risperdal Initial or Prolonged Professional (Risperidone) PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3127098-5Report Type:Periodic Company Report #JAUSA-30931 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blepharospasm Health Risperdal Professional (Risperidone) PS Janssen ORAL 6 MG ORAL Date:03/12/98ISR Number: 3127101-2Report Type:Periodic Company Report #JAUSA-30932 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3127104-8Report Type:Periodic Company Report #JAUSA-30933 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Risperdal Initial or Prolonged Professional (Risperidone) PS Janssen ORAL 3 MG DAILY ORAL Zoloft (Sertraline) C Wellbutrin (Amfebutamone) C Date:03/12/98ISR Number: 3127108-5Report Type:Periodic Company Report #JAUSA-30934 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 2 DAILY ORAL Cogentin (Benztropine) C Lithium (Lithium) C 22-Feb-2006 08:20 AM Page: 46 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3127110-3Report Type:Periodic Company Report #JAUSA-30935 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone) PS Janssen ORAL 2 MG 1 DAILY ORAL Date:03/12/98ISR Number: 3127112-7Report Type:Periodic Company Report #JAUSA-30936 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Risperdal Initial or Prolonged Professional (Risperidone) PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3127115-2Report Type:Periodic Company Report #JAUSA-30937 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Engorgement Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 2 MG DAILY ORAL; 1 MG DAILY Date:03/12/98ISR Number: 3127118-8Report Type:Periodic Company Report #JAUSA-30938 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 4 MG 3 DAILY ORAL Cogentin (Benztropine) C Tegretol (Carbamazepine) C Dapakote (Valproate Sodium) C Date:03/12/98ISR Number: 3127164-4Report Type:Periodic Company Report #JAUSA-30832 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone) PS Janssen, ORAL TABLET; 3 DAILY ORAL Buspar (Buspirone) C Date:03/12/98ISR Number: 3127166-8Report Type:Periodic Company Report #JAUSA-30854 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal PS Janssen ORAL TABLET; 2 MG Periorbital Oedema Professional DAILY ORAL Prednisone C 22-Feb-2006 08:20 AM Page: 47 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3127167-XReport Type:Periodic Company Report #JAUSA-30869 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Palpitations Health Risperdal PS Janssen ORAL TABLET; 2 MG Tachycardia Professional 1 DAILY ORAL Trilafon C Zoloft C Date:03/12/98ISR Number: 3127168-1Report Type:Periodic Company Report #JAUSA-30870 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET; 1 MG 1 DAILY ORAL Zoloft C Date:03/12/98ISR Number: 3127170-XReport Type:Periodic Company Report #JAUSA-30871 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Gynaecomastia Professional (Risperidone) PS Janssen ORAL TABLET; ORAL Hyperprolactinaemia Anafranil C Weight Increased Date:03/12/98ISR Number: 3127172-3Report Type:Periodic Company Report #JAUSA-30872 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal PS Janssen ORAL TABLET, ORAL Professional Date:03/12/98ISR Number: 3127174-7Report Type:Periodic Company Report #JAUSA-30874 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Failure Health Risperdal Rhinitis Professional (Risperidone) PS Janssen ORAL TABLET, ORAL Lithium C Zyprexa C Date:03/12/98ISR Number: 3127177-2Report Type:Periodic Company Report #JAUSA-30875 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Risperdal PS Janssen ORAL TABLET, ORAL Professional Date:03/12/98ISR Number: 3127180-2Report Type:Periodic Company Report #JAUSA-30876 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL TABLET, ORAL Professional 22-Feb-2006 08:20 AM Page: 48 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3127183-8Report Type:Periodic Company Report #JAUSA-30877 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL TABLET, ORAL Professional Date:03/12/98ISR Number: 3127185-1Report Type:Periodic Company Report #JAUSA-30878 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Consumer Risperdal Chest Pain (Risperidone) PS Janssen ORAL TABLET, 1 Palpitations DAILY ORAL Lithium C Zoloft C Artane C Date:03/12/98ISR Number: 3127186-3Report Type:Periodic Company Report #JAUSA-30880 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Health Risperdal Hypercholesterolaemia Professional (Risperidone) PS Janssen ORAL TABLET, ORAL Hypertriglyceridaemia Weight Increased Date:03/12/98ISR Number: 3127187-5Report Type:Periodic Company Report #JAUSA-30904 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Gynaecomastia Professional (Risperidone) PS Janssen ORAL TABLET, ORAL Date:03/12/98ISR Number: 3127189-9Report Type:Periodic Company Report #JAUSA-30905 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Consumer Risperdal PS Janssen ORAL SEE IMAGE Vitamins C (Vitamins, Unspec) C Guaifenesin C Date:03/12/98ISR Number: 3127195-4Report Type:Periodic Company Report #JAUSA-30922 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL TABLET, ORAL Gynaecomastia Professional Date:03/12/98ISR Number: 3127199-1Report Type:Periodic Company Report #JAUSA-30923 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal PS Janssen ORAL TABLET, ORAL Professional 22-Feb-2006 08:20 AM Page: 49 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3127202-9Report Type:Periodic Company Report #JAUSA-30924 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hiccups Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, 3 MG 2 DAILY ORAL Thorazine C Date:03/12/98ISR Number: 3127204-2Report Type:Periodic Company Report #JAUSA-30926 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hiccups Health Risperdal PS Janssen ORAL TABLET, 1 MG Professional 2 DAILY ORAL Date:03/12/98ISR Number: 3127205-4Report Type:Periodic Company Report #JAUSA-30927 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hiccups Health Risperdal PS Janssen ORAL TABLET, 2 MG Professional 2 DAILY ORAL 1 MON Date:03/12/98ISR Number: 3127208-XReport Type:Periodic Company Report #JAUSA-30928 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hiccups Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, 3 MG 2 DAILY ORAL 5 DAY Date:03/12/98ISR Number: 3127339-4Report Type:Periodic Company Report #JAUSA-28403 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal PS Professional Clonidine (Clonidine) SS Wellbutrin (Amfebutamone) SS Date:03/12/98ISR Number: 3127342-4Report Type:Periodic Company Report #JAUSA-28420 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal PS Janssen ORAL ORAL 3 WK Professional Date:03/12/98ISR Number: 3127345-XReport Type:Periodic Company Report #JAUSA-28421 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal PS Janssen ORAL ORAL Anxiety Professional Condition Aggravated 22-Feb-2006 08:20 AM Page: 50 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3127347-3Report Type:Periodic Company Report #JAUSA-28423 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Consumer Risperdal PS Janssen ORAL 2 MG DAILY Involuntary ORAL Paxil C Premarin C Axid C Allopurinol C Clarityn C Maxzide C Synthroid C Date:03/12/98ISR Number: 3127351-5Report Type:Periodic Company Report #JAUSA-28424 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal PS Janssen ORAL 4 MG DAILY Weight Increased ORAL Thorazine C Date:03/12/98ISR Number: 3127354-0Report Type:Periodic Company Report #JAUSA-28440 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Risperdal PS Janssen ORAL 11 MG DAILY 7 DAY Priapism Professional Date:03/12/98ISR Number: 3127356-4Report Type:Periodic Company Report #JAUSA-28442 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal PS Janssen ORAL 2 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3127359-XReport Type:Periodic Company Report #JAUSA-28443 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Consumer Risperdal PS Janssen ORAL 1 MG 3 DAILY Confusional State ORAL Hyperhidrosis Lacrimal Disorder Polyuria Date:03/12/98ISR Number: 3127362-XReport Type:Periodic Company Report #JAUSA-28444 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Risperdal PS Janssen ORAL 1 MG DAILY Oedema Professional ORAL Depakote C Insulin C 22-Feb-2006 08:20 AM Page: 51 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3127364-3Report Type:Periodic Company Report #JAUSA-28452 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Consumer Risperdal PS Janssen ORAL 5 MG DAILY Pollakiuria ORAL Date:03/12/98ISR Number: 3127368-0Report Type:Periodic Company Report #JAUSA-28453 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Risperdal PS Janssen ORAL 4 MG DAILY Initial or Prolonged Insomnia ORAL Sedation Lithium C Serzone C Lorazepam C Date:03/12/98ISR Number: 3127371-0Report Type:Periodic Company Report #JAUSA-28455 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 6 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3127375-8Report Type:Periodic Company Report #JAUSA-28457 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 2.5 MG DAILY Professional ORAL Lithium C Tegretol C Date:03/12/98ISR Number: 3127379-5Report Type:Periodic Company Report #JAUSA-28459 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 6, & 12 MG Professional DAILY ORAL 22 WK Date:03/12/98ISR Number: 3127382-5Report Type:Periodic Company Report #JAUSA-28467 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Purpura Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Professional ORAL Paxil C Date:03/12/98ISR Number: 3127386-2Report Type:Periodic Company Report #JAUSA-28497 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 1 MG DAILY Professional ORAL 22-Feb-2006 08:20 AM Page: 52 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3127388-6Report Type:Periodic Company Report #JAUSA-28498 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperdal PS Janssen ORAL 6 MG DAILY ORAL Haldol C Date:03/12/98ISR Number: 3127391-6Report Type:Periodic Company Report #JAUSA-28499 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 8 MG DAILY Professional ORAL Congentin C Vistaril C Date:03/12/98ISR Number: 3127394-1Report Type:Periodic Company Report #JAUSA-28515 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Weight Increased Professional ORAL Date:03/12/98ISR Number: 3127397-7Report Type:Periodic Company Report #JAUSA-28516 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3127624-6Report Type:Periodic Company Report #JAUSA-28206 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Deficit/Hyperactivity Professional ORAL;2MG Disorder 2DAILY ORAL; Condition Aggravated 2MG 3 DAILY ORAL 2 YR Verapamil C Naprosyn C Date:03/12/98ISR Number: 3127627-1Report Type:Periodic Company Report #JAUSA-28207 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Professional ORAL Date:03/12/98ISR Number: 3127629-5Report Type:Periodic Company Report #JAUSA-28208 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL ORAL Professional 22-Feb-2006 08:20 AM Page: 53 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3127634-9Report Type:Periodic Company Report #JAUSA-28209 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal PS Janssen ORAL 3, & 4 MG Professional DAILY ORAL 19 DAY Date:03/12/98ISR Number: 3127658-1Report Type:Periodic Company Report #JAUSA-28210 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Risperdal PS Janssen ORAL ORAL Gait Disturbance Professional Date:03/12/98ISR Number: 3127662-3Report Type:Periodic Company Report #JAUSA-28211 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL .5 & 1.5 MG Professional DAILY Paxil C Date:03/12/98ISR Number: 3127664-7Report Type:Periodic Company Report #JAUSA-28213 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3127675-1Report Type:Periodic Company Report #JAUSA-28214 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal PS Janssen ORAL ORAL Muscle Contractions Involuntary Pain Sedation Date:03/12/98ISR Number: 3127677-5Report Type:Periodic Company Report #JAUSA-28216 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphadenopathy Health Risperdal PS Janssen ORAL 5 MG ORAL Professional Date:03/12/98ISR Number: 3127680-5Report Type:Periodic Company Report #JAUSA-28218 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Albuminuria Health Risperdal PS Janssen ORAL ORAL Professional Clozaril C 22-Feb-2006 08:20 AM Page: 54 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3127684-2Report Type:Periodic Company Report #JAUSA-28220 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Risperdal PS Janssen ORAL 1 MG DAILY Constipation Professional ORAL Date:03/12/98ISR Number: 3127687-8Report Type:Periodic Company Report #JAUSA-28221 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal PS Janssen ORAL 2 MG DAILY Professional ORAL Paxil C Trazodone C Date:03/12/98ISR Number: 3127690-8Report Type:Periodic Company Report #JAUSA-28230 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Consumer Risperdal PS Janssen ORAL 2 & 3 MG 2 Initial or Prolonged Urinary Incontinence DAILY ORAL Lithium C Depakote C Clonopin C Inderal C Prilosec C Date:03/12/98ISR Number: 3127693-3Report Type:Periodic Company Report #JAUSA-28257 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Professional ORAL;1MG 1 DAILY ORAL Benzotropine C Dilantin C Klonopin C Date:03/12/98ISR Number: 3127696-9Report Type:Periodic Company Report #JAUSA-28259 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Risperdal PS Janssen ORAL 4 MG DAILY Migraine Professional ORAL Date:03/12/98ISR Number: 3127698-2Report Type:Periodic Company Report #JAUSA-28260 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal PS Janssen ORAL 4 MG DAILY Professional ORAL 22-Feb-2006 08:20 AM Page: 55 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3127700-8Report Type:Periodic Company Report #JAUSA-28262 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Risperdal PS Janssen ORAL 6 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3127702-1Report Type:Periodic Company Report #JAUSA-28264 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL DAILY ORAL 26 WK Professional Serzone C Date:03/12/98ISR Number: 3127704-5Report Type:Periodic Company Report #JAUSA-28265 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Deficit/Hyperactivity Professional ORAL Disorder Date:03/12/98ISR Number: 3127706-9Report Type:Periodic Company Report #JAUSA-28267 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Health Risperdal PS Janssen ORAL 6 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3127711-2Report Type:Periodic Company Report #JAUSA-28069 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Urea Increased Health Risperidal Professional (Risperidone) PS ORAL 6 MG DAILY ORAL Clozapine C Date:03/12/98ISR Number: 3127714-8Report Type:Periodic Company Report #JAUSA-28070 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Consumer Risperidal Involuntary (Risperidone) PS ORAL 2 MG 2 DAILY ORAL Paxil C Date:03/12/98ISR Number: 3127716-1Report Type:Periodic Company Report #JAUSA-28071 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Increased Appetite Consumer Risperidal Muscle Spasms (Risperidone) PS ORAL 1.25 MG DAILY Weight Increased ORAL Catapres C 22-Feb-2006 08:20 AM Page: 56 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3127719-7Report Type:Periodic Company Report #JAUSA-28072 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperidal Sedation (Risperidone) PS ORAL 6 MG DAILY ORAL; 4 MG DAILY ORAL TABLET Klonopin C Date:03/12/98ISR Number: 3127723-9Report Type:Periodic Company Report #JAUSA-28073 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Risperdal Professional (Risperidone) PS ORAL 3 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3127727-6Report Type:Periodic Company Report #JAUSA-28075 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Risperidal (Risperidone) PS ORAL 6 MG 2 DAILY ORAL Lithium C Date:03/12/98ISR Number: 3127730-6Report Type:Periodic Company Report #JAUSA-28076 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Health Risperidal Professional (Risperidone) PS ORAL ORAL Unspecified C Date:03/12/98ISR Number: 3127734-3Report Type:Periodic Company Report #JAUSA-28077 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Health Risperdal Professional (Risperidone) PS ORAL 3 MG DAILY ORAL 3 YR Date:03/12/98ISR Number: 3127740-9Report Type:Periodic Company Report #JAUSA-28079 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Spasms Health Risperdal Professional (Risperidone) PS ORAL 1 MG 1 DAILY ORAL 22-Feb-2006 08:20 AM Page: 57 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3127744-6Report Type:Periodic Company Report #JAUSA28080 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal Tardive Dyskinesia (Risperidone) PS ORAL 3 MG ORAL Thorazine C Date:03/12/98ISR Number: 3127749-5Report Type:Periodic Company Report #JAUSA-28083 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Albuminuria Health Risperdal Attention Professional (Risperidone) PS ORAL 8 MG DAILY Deficit/Hyperactivity ORAL; 2 MG Disorder DAILY ORAL 6 MON Blood Urea Increased Cogentin C Date:03/12/98ISR Number: 3127753-7Report Type:Periodic Company Report #JAUSA-28112 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Health Risperdal Initial or Prolonged Professional (Risperidone) PS ORAL 2 MG DAILY ORAL; 3 MG DAILY ORAL TABLET; 3 MG DAILY ORAL 10 MON Date:03/12/98ISR Number: 3127757-4Report Type:Periodic Company Report #JAUSA-28113 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS ORAL 6 MG DAILY ORAL Date:03/12/98ISR Number: 3127762-8Report Type:Periodic Company Report #JAUSA-28114 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS ORAL 8 MG DAILY ORAL;2 MG IN AM, 6 MG IN PM Date:03/12/98ISR Number: 3127767-7Report Type:Periodic Company Report #JAUSA-28115 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS ORAL 2 MG DAILY ORAL 22-Feb-2006 08:20 AM Page: 58 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3127771-9Report Type:Periodic Company Report #JAUSA-28116 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS ORAL 12 MG DAILY ORAL Paxil C Cogentin C Date:03/12/98ISR Number: 3127774-4Report Type:Periodic Company Report #JAUSA-28117 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS ORAL 7 MG DAILY ORAL Date:03/12/98ISR Number: 3127777-XReport Type:Periodic Company Report #JAUSA-28118 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Arrest Health Risperdal Professional (Risperidone) PS ORAL ORAL Unspecified C Date:03/12/98ISR Number: 3127783-5Report Type:Periodic Company Report #JAUSA-28120 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS ORAL DAILY, ORAL Prolixin C Date:03/12/98ISR Number: 3127787-2Report Type:Periodic Company Report #JAUSA-28122 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS ORAL 2 MG DAILY ORAL Valium C Date:03/12/98ISR Number: 3127985-8Report Type:Periodic Company Report #JAUSA-28632 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Semen Abnormal Health Risperdal PS Janssen ORAL 2 MG DAILY Professional ORAL Depakote C 22-Feb-2006 08:20 AM Page: 59 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3127988-3Report Type:Periodic Company Report #JAUSA-28633 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Photosensitivity Reaction Health Risperdal PS Janssen ORAL 3 MG DAILY Professional ORAL; 2 MG DAILY ORAL; TABLET Date:03/12/98ISR Number: 3127991-3Report Type:Periodic Company Report #JAUSA-28634 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen ORAL 1 MG DAILY Initial or Prolonged Depression ORAL; 4 MG DAILY ORAL; 6 MG DAILY ORAL; TABLET Klonopin C Date:03/12/98ISR Number: 3127995-0Report Type:Periodic Company Report #JAUSA-28635 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Increased Appetite Consumer Risperdal PS Janssen ORAL 8 MG DAILY Weight Increased ORAL Depakote C Lithium C Prozac C Date:03/12/98ISR Number: 3127999-8Report Type:Periodic Company Report #JAUSA-28637 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothermia Health Risperdal PS Janssen ORAL ORAL Injury Professional Date:03/12/98ISR Number: 3128002-6Report Type:Periodic Company Report #JAUSA-28639 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Consumer Risperdal PS Janssen ORAL 3 MG,4 MG,5 Initial or Prolonged Condition Aggravated MG, 3 MG; 2 Dyskinesia DAILY; ORAL; Weight Increased TABLET 8 WK Cogentin C Cogentin C Klonopin C Vasotec C Xanax C Date:03/12/98ISR Number: 3128004-XReport Type:Periodic Company Report #JAUSA-28640 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal PS Janssen ORAL ORAL Professional 22-Feb-2006 08:20 AM Page: 60 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3128006-3Report Type:Periodic Company Report #JAUSA-28641 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Consumer Risperdal PS Janssen ORAL 2 MG 2 DAILY Deficit/Hyperactivity ORAL Disorder Ativan (Lorazepam) C Sedation Date:03/12/98ISR Number: 3128008-7Report Type:Periodic Company Report #JAUSA-28642 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Risperdal PS Janssen ORAL 1 MG 3 DAILY Attention ORAL Deficit/Hyperactivity Disorder Date:03/12/98ISR Number: 3128012-9Report Type:Periodic Company Report #JAUSA-28643 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3128014-2Report Type:Periodic Company Report #JAUSA-28644 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL .5 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3128016-6Report Type:Periodic Company Report #JAUSA-28667 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3128019-1Report Type:Periodic Company Report #JAUSA-28673 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gingivitis Health Risperdal PS Janssen ORAL 1 MG 1 DAILY Professional ORAL; 2 MG 1 DAILY Paxil C Zoloft C Date:03/12/98ISR Number: 3128023-3Report Type:Periodic Company Report #JAUSA-28711 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Risperdal PS Janssen ORAL 2.5 MG, 3 MG, Professional 2 MG; 1 DAILY; ORAL; 22-Feb-2006 08:20 AM Page: 61 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report TABLET Prozac C Date:03/12/98ISR Number: 3128024-5Report Type:Periodic Company Report #JAUSA-28713 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Risperdal PS Janssen ORAL ORAL Tremor Professional Date:03/12/98ISR Number: 3128026-9Report Type:Periodic Company Report #JAUSA-28714 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Risperdal PS Janssen ORAL ORAL Professional Dilantin SS Nortriptyline C Date:03/12/98ISR Number: 3128029-4Report Type:Periodic Company Report #JAUSA-28716 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY Libido Decreased ORAL Prolixin C Ativan C Trazodone C Date:03/12/98ISR Number: 3128032-4Report Type:Periodic Company Report #JAUSA-28718 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL 3 MG 1 DAILY Galactorrhoea Professional ORAL Sedation Zoloft C Visual Disturbance Date:03/12/98ISR Number: 3128039-7Report Type:Periodic Company Report #JAUSA-28720 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal PS Janssen ORAL 1 MG 1 DAILY Professional ORAL Date:03/12/98ISR Number: 3128041-5Report Type:Periodic Company Report #JAUSA-28721 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicide Attempt Consumer Risperdal PS Janssen ORAL 2 MG 2 DAILY ORAL Lithium C 22-Feb-2006 08:20 AM Page: 62 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3128486-3Report Type:Periodic Company Report #JAUSA-28126 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3128488-7Report Type:Periodic Company Report #JAUSA-28166 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Risperdal PS Janssen ORAL 1 MG DAILY ORAL,4 MG DAILY ORAL ... C Date:03/12/98ISR Number: 3128492-9Report Type:Periodic Company Report #JAUSA-28170 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 3 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3128494-2Report Type:Periodic Company Report #JAUSA-28171 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 12 MG DAILY Professional ORAL Klonopin C Effexor C Depakote C Date:03/12/98ISR Number: 3128497-8Report Type:Periodic Company Report #JAUSA-28172 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Risperdal PS Janssen ORAL 1 MG DAILY ORAL Sinequan C Date:03/12/98ISR Number: 3128502-9Report Type:Periodic Company Report #JAUSA-28173 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 6 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3128503-0Report Type:Periodic Company Report #JAUSA-28174 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 6 MG DAILY Professional ORAL Cogentin C 22-Feb-2006 08:20 AM Page: 63 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3128504-2Report Type:Periodic Company Report #JAUSA-28175 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 6 MG DAILY Professional ORAL Lithium C Ativan C Date:03/12/98ISR Number: 3128505-4Report Type:Periodic Company Report #JAUSA-28176 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Consumer Risperdal PS ORAL -,ORAL Lithium C Date:03/12/98ISR Number: 3128508-XReport Type:Periodic Company Report #JAUSA-28180 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3128509-1Report Type:Periodic Company Report #JAUSA-28182 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Risperdal PS Janssen ORAL 3 MG 2 DAILY Hyperglycaemia ORAL, Date:03/12/98ISR Number: 3128512-1Report Type:Periodic Company Report #JAUSA-28186 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal PS ORAL 1 MG 2 DAILY Tremor ORAL Weight Increased Benztropine C Date:03/12/98ISR Number: 3128515-7Report Type:Periodic Company Report #JAUSA-28190 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS ORAL -, ORAL Professional Zoloft C Date:03/12/98ISR Number: 3128519-4Report Type:Periodic Company Report #JAUSA-28192 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Consumer Risperdal PS Janssen ORAL 1 MG DAILY Vomiting ORAL 22-Feb-2006 08:20 AM Page: 64 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3128523-6Report Type:Periodic Company Report #JAUSA-28193 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chills Health Risperdal PS Janssen ORAL 2 MG DAILY Galactorrhoea Professional ORAL,1 MG Tremor DAILY ORAL 4 MON Effexor C Xanax C Date:03/12/98ISR Number: 3128525-XReport Type:Periodic Company Report #JAUSA-28196 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Palpitations Consumer Risperdal PS Janssen ORAL -, ORAL Paraesthesia Mellaril C Dilantin C Date:03/12/98ISR Number: 3128528-5Report Type:Periodic Company Report #JAUSA-28200 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL 2 MG 2 DAILY Professional ORAL Date:03/12/98ISR Number: 3128533-9Report Type:Periodic Company Report #JAUSA-28202 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 2 MG 2 DAILY Galactorrhoea Professional ORAL Hyperprolactinaemia Date:03/12/98ISR Number: 3128535-2Report Type:Periodic Company Report #JAUSA-28204 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Galactorrhoea Professional ORAL;2 MG 2 DAILY Date:03/12/98ISR Number: 3128537-6Report Type:Periodic Company Report #JAUSA-28205 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Professional ORAL Date:03/12/98ISR Number: 3128635-7Report Type:Periodic Company Report #JAUSA-28271 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL .5 MG DAILY Professional ORAL Depakote C 22-Feb-2006 08:20 AM Page: 65 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3128638-2Report Type:Periodic Company Report #JAUSA-28272 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscular Weakness Consumer Risperdal PS Janssen ORAL .25 MG 1 Sedation WEEKLY ORAL Depakote C Aricept C Date:03/12/98ISR Number: 3128711-9Report Type:Periodic Company Report #JAUSA-28517 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Risperdal PS Janssen ORAL 4MG DAILY Pain Professional ORAL, .5MG 2 Tremor DAILY ORAL Estrogens C Date:03/12/98ISR Number: 3128713-2Report Type:Periodic Company Report #JAUSA-28518 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3128715-6Report Type:Periodic Company Report #JAUSA-28519 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 8MG DAILY Muscle Contractions Professional ORAL Involuntary Date:03/12/98ISR Number: 3128717-XReport Type:Periodic Company Report #JAUSA-28520 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal PS Janssen ORAL 12MG DAILY Decreased Professional ORAL AT BED TIME Zoloft C Date:03/12/98ISR Number: 3128719-3Report Type:Periodic Company Report #JAUSA-28528 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Consumer Risperdal PS Janssen ORAL 1MG DAILY Decreased ORAL Ativan C Date:03/12/98ISR Number: 3128720-XReport Type:Periodic Company Report #JAUSA-28529 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 6MG DAILY Professional ORAL 22-Feb-2006 08:20 AM Page: 66 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3128721-1Report Type:Periodic Company Report #JAUSA-28530 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Consumer Risperdal PS Janssen ORAL 6MG DAILY Decreased ORAL Date:03/12/98ISR Number: 3128722-3Report Type:Periodic Company Report #JAUSA-28531 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal PS Janssen ORAL 3MG DAILY Decreased Professional ORAL Date:03/12/98ISR Number: 3128723-5Report Type:Periodic Company Report #JAUSA-28534 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 6MG DAILY Professional ORAL Date:03/12/98ISR Number: 3128724-7Report Type:Periodic Company Report #JAUSA-28543 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Risperdal PS Janssen ORAL 1MG 2 DAILY Initial or Prolonged Professional ORAL Buspar C Trazodone C Reglan C Pepcid C Date:03/12/98ISR Number: 3128725-9Report Type:Periodic Company Report #JAUSA-28544 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Contractions Health Risperdal PS Janssen ORAL 1MG 1 DAILY Initial or Prolonged Involuntary Professional ORAL TAKEN AT BEDTIME Wellbutrin C Tenex C Date:03/12/98ISR Number: 3128726-0Report Type:Periodic Company Report #JAUSA-28545 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Angioneurotic Oedema Health Risperdal PS Janssen Hospitalization - Professional Initial or Prolonged Date:03/12/98ISR Number: 3128727-2Report Type:Periodic Company Report #JAUSA-28546 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL 9MG DAILY Professional ORAL NOT 22-Feb-2006 08:20 AM Page: 67 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report TREATED FOR YEARS Date:03/12/98ISR Number: 3128728-4Report Type:Periodic Company Report #JAUSA-28547 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS Janssen ORAL 2MG 2 DAILY Hyperprolactinaemia ORAL, 1MG Menstrual Disorder DAILY ORAL Date:03/12/98ISR Number: 3128729-6Report Type:Periodic Company Report #JAUSA-28548 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL 1MG 2 DAILY Leukopenia Professional ORAL 1MG A.M. 1MG P.M. Ativan C Cogentin C Date:03/12/98ISR Number: 3128730-2Report Type:Periodic Company Report #JAUSA-28549 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal PS Janssen ORAL 6MG 2 DAILY Professional ORAL Artane C Mellaril C Date:03/12/98ISR Number: 3128731-4Report Type:Periodic Company Report #JAUSA-28550 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 3MG 2 DAILY Professional ORAL, 1 MG .4MG 2 DAILY ORAL Date:03/12/98ISR Number: 3128732-6Report Type:Periodic Company Report #JAUSA-28551 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal PS Janssen ORAL 1MG DAILY ORAL,6MG DAILY ORAL Depakote C Klonopin C Date:03/12/98ISR Number: 3128733-8Report Type:Periodic Company Report #JAUSA-28552 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Health Risperidal PS Janssen ORAL 2MG 2 DAILY Professional ORAL Cogentin C 22-Feb-2006 08:20 AM Page: 68 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3128734-XReport Type:Periodic Company Report #JAUSA-28553 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Maculo-Papular Health Risperdal PS Janssen ORAL 1.5MG DAILY Professional ORAL. , .5 MG DAILY ORAL Tegretol C Date:03/12/98ISR Number: 3128741-7Report Type:Periodic Company Report #JAUSA-28275 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperdal PS Janssen ORAL 12 MG DAILY Weight Increased ORAL 7 MON Depakote C Cogentin C Donipramine C Date:03/12/98ISR Number: 3128743-0Report Type:Periodic Company Report #JAUSA-28287 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal PS Janssen ORAL -, ORAL Professional Date:03/12/98ISR Number: 3128745-4Report Type:Periodic Company Report #JAUSA-28290(E) Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hair Texture Abnormal Consumer Risperdal PS Janssen ORAL .5 MG 2 DAILY ORAL Depakote C Date:03/12/98ISR Number: 3128749-1Report Type:Periodic Company Report #JAUSA-28291 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Health Risperdal PS Janssen ORAL 3 MG DAILY Purpura Professional ORAL Date:03/12/98ISR Number: 3128752-1Report Type:Periodic Company Report #JAUSA-28295 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL 3 MG ORAL; Pollakiuria Professional 4MG Zoloft C Date:03/12/98ISR Number: 3128753-3Report Type:Periodic Company Report #JAUSA-28297 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS ORAL 3 MG DAILY Hyperprolactinaemia ORAL Platelet Disorder Mellaril C 22-Feb-2006 08:20 AM Page: 69 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Macrodantin C Date:03/12/98ISR Number: 3128754-5Report Type:Periodic Company Report #JAUSA-28298 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal PS Janssen ORAL 1 MG DAILY Professional ORAL; 2 MG DAILY; 1.5 MG DAILY Date:03/12/98ISR Number: 3128755-7Report Type:Periodic Company Report #JAUSA-28300 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Consumer Risperdal PS Janssen ORAL 1 MG DAILY Hyperprolactinaemia ORAL Date:03/12/98ISR Number: 3128757-0Report Type:Periodic Company Report #JAUSA-28301 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Health Risperdal PS Janssen ORAL .5 MG DAILY Sedation Professional ORAL; .15 MG DAILY ORAL Isosorbide C Date:03/12/98ISR Number: 3128759-4Report Type:Periodic Company Report #JAUSA-28310 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 14 MG DAILY Hyperprolactinaemia Professional ORAL Libido Decreased Prolixin C Date:03/12/98ISR Number: 3128761-2Report Type:Periodic Company Report #JAUSA-28311 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 1.5 MG DAILY Sedation Professional ORAL Luvox C Date:03/12/98ISR Number: 3128764-8Report Type:Periodic Company Report #JAUSA-28312 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 6 MG DAILY Extrapyramidal Disorder Professional ORAL 22-Feb-2006 08:20 AM Page: 70 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3128767-3Report Type:Periodic Company Report #JAUSA-28314 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Risperdal PS Janssen ORAL -, ORAL Drug Interaction Professional Depakote C Dyspnoea Oedema Weight Increased Date:03/12/98ISR Number: 3128770-3Report Type:Periodic Company Report #JAUSA-28316 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS Janssen ORAL 4 MG 2 DAILY ORAL Cogentin C Date:03/12/98ISR Number: 3128772-7Report Type:Periodic Company Report #JAUSA-28317 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Consumer Risperdal PS Janssen ORAL 1 MG ORAL Weight Increased Date:03/12/98ISR Number: 3128775-2Report Type:Periodic Company Report #JAUSA-28318 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Health Risperdal PS Janssen ORAL 2 MG DAILY Professional ORAL Lithium C Inhalant Unspec. C Date:03/12/98ISR Number: 3128780-6Report Type:Periodic Company Report #JAUSA-28323 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Risperdal PS Janssen ORAL 8 MG DAILY Phosphokinase Increased Professional ORAL; 10 MG Dizziness DAILY Tegretol C Depakote C Date:03/12/98ISR Number: 3128784-3Report Type:Periodic Company Report #JAUSA-28325 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pollakiuria Health Risperdal PS Janssen ORAL 8 MG DAILY Polyuria Professional ORAL 22-Feb-2006 08:20 AM Page: 71 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3128982-9Report Type:Periodic Company Report #JAUSA-28722 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nail Disorder Risperdal (Risperidone) PS Janssen ORAL 6MG DAILY ORAL Antidepressants C Date:03/12/98ISR Number: 3128984-2Report Type:Periodic Company Report #JAUSA-28723 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal Injury (Risperidone) PS Janssen ORAL 1MG 1 DAILY Purpura ORAL Sedation Date:03/12/98ISR Number: 3128987-8Report Type:Periodic Company Report #JAUSA-28728 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Zoloft C Date:03/12/98ISR Number: 3128989-1Report Type:Periodic Company Report #JAUSA-28554 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Consumer Risperdal PS ORAL DAILY Involuntary Date:03/12/98ISR Number: 3128991-XReport Type:Periodic Company Report #JAUSA-28731 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Increased Appetite Health Risperdal Professional (Risperidone) PS Janssen ORAL .5MG 2 DAILY ORAL, 2.5MG DAILY ORAL, 1MG IN AM, 1.5MG IN PM, Prednisone C Date:03/12/98ISR Number: 3128993-3Report Type:Periodic Company Report #JAUSA-28555 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal PS ORAL 2 MG DAILY Professional 22-Feb-2006 08:20 AM Page: 72 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3128995-7Report Type:Periodic Company Report #JAUSA-28732 Age:97 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tongue Discolouration Health Risperdal Professional (Risperidone) PS Janssen ORAL .5MG 1 DAILY ORAL, .25MG 1 DAILY ORAL Ferrous Sulfate C Date:03/12/98ISR Number: 3128996-9Report Type:Periodic Company Report #JAUSA-28556 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Risperdal PS ORAL 1 MG DAILY Vomiting Professional Date:03/12/98ISR Number: 3128999-4Report Type:Periodic Company Report #JAUSA-28558 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS ORAL 6 MG DAILY Breast Pain Professional Artane Galactorrhoea (Trihexyphenidyl) C Hyperprolactinaemia Luvox (Fluvoxamine) C Date:03/12/98ISR Number: 3129001-0Report Type:Periodic Company Report #JAUSA-28560 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Risperdal PS ORAL 6 MG DAILY Muscle Contractions Professional Involuntary Date:03/12/98ISR Number: 3129002-2Report Type:Periodic Company Report #JAUSA-28561 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal PS ORAL 3 MG 2 DAILY 3 MON Professional Date:03/12/98ISR Number: 3129005-8Report Type:Periodic Company Report #JAUSA-28562 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Health Risperdal PS ORAL DAILY Oculogyration Professional Date:03/12/98ISR Number: 3129008-3Report Type:Periodic Company Report #JAUSA-28563 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyponatraemia Health Risperdal PS ORAL Professional 22-Feb-2006 08:20 AM Page: 73 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3129011-3Report Type:Periodic Company Report #JAUSA-28564 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal PS ORAL 3 MG DAILY Professional Date:03/12/98ISR Number: 3129015-0Report Type:Periodic Company Report #JAUSA-28565 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS ORAL 8 MG DAILY Professional Date:03/12/98ISR Number: 3129030-7Report Type:Periodic Company Report #JAUSA-28566 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Health Risperdal PS ORAL 3 MG DAILY Professional Navane SS Cogentin (Benztropine) C Elavil (Amitriptyline) C Valium (Diazepam) C Date:03/12/98ISR Number: 3129034-4Report Type:Periodic Company Report #JAUSA-28326 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal PS ORAL 3 MG DAILY Galactorrhoea Professional ORAL Hypertonia Urinary Incontinence Date:03/12/98ISR Number: 3129038-1Report Type:Periodic Company Report #JAUSA-28329 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Menorrhagia Consumer Risperdal PS Janssen ORAL 3 MG DAILY Thrombocythaemia ORAL Weight Increased Paxil C Adderall C Date:03/12/98ISR Number: 3129040-XReport Type:Periodic Company Report #JAUSA-28567 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gingival Infection Health Risperdal PS ORAL 4 MG 2 DAILY Hypertonia Professional 22-Feb-2006 08:20 AM Page: 74 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3129042-3Report Type:Periodic Company Report #JAUSA-28336 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal PS Janssen ORAL 3 MG DAILY Suicide Attempt Professional ORAL Depakote SS 500 MG 3 DAILY Klonopin (Clonazepam) C Date:03/12/98ISR Number: 3129043-5Report Type:Periodic Company Report #JAUSA-28366 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cough Health Risperdal PS Janssen ORAL 10 MG DAILY Professional ORAL Haldol (Haloperidol0 C Date:03/12/98ISR Number: 3129045-9Report Type:Periodic Company Report #JAUSA-28368 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal PS ORAL 3 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3129047-2Report Type:Periodic Company Report #JAUSA-28369 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Health Risperdal PS Janssen ORAL 8 MG DAILY Fatigue Professional ORAL Haldol (Haloperidol) C Date:03/12/98ISR Number: 3129049-6Report Type:Periodic Company Report #JAUSA-28371 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Risperdal PS Janssen ORAL 2 MG DAILY Condition Aggravated Professional ORAL Date:03/12/98ISR Number: 3129051-4Report Type:Periodic Company Report #JAUSA-28372 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Health Risperdal PS Janssen ORAL 6 MG DAILY Thinking Abnormal Professional ORAL Ephedrine SS ORAL DAILY ORAL Date:03/12/98ISR Number: 3129053-8Report Type:Periodic Company Report #JAUSA-28374 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal PS Janssen ORAL 6 MG DAILY Professional ORAL Paxil (Paroxetine) C 22-Feb-2006 08:20 AM Page: 75 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Buspar (Buspirone) C Date:03/12/98ISR Number: 3129068-XReport Type:Periodic Company Report #JAUSA-28568 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal PS ORAL 6 MG DAILY Anxiety Antihistamines SS ORAL 6 MG DAILY Zoloft (Sertraline) C Date:03/12/98ISR Number: 3129069-1Report Type:Periodic Company Report #JAUSA-28569 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS ORAL 6 MG DAY Galactorrhoea Professional Date:03/12/98ISR Number: 3129071-XReport Type:Periodic Company Report #JAUSA-28571 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal PS ORAL 5 MG DAILY Dry Mouth Professional Procardia C Hyponatraemia Polyuria Thirst Date:03/12/98ISR Number: 3129075-7Report Type:Periodic Company Report #JAUSA-28572 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal PS ORAL .5 MG 2 DAILY Professional Date:03/12/98ISR Number: 3129078-2Report Type:Periodic Company Report #JAUSA-28578(E) Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal PS ORAL 1 MG 1 DAILY Date:03/12/98ISR Number: 3129080-0Report Type:Periodic Company Report #JAUSA-28579 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Risperdal PS ORAL 4 MG 4 WK Asthenia Ambien (Zolpidem) C Confusional State Ativan (Lorazepam) C Muscle Contractions Paxil (Paroxetine) C Involuntary Sedation Tremor Visual Disturbance 22-Feb-2006 08:20 AM Page: 76 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3129119-2Report Type:Periodic Company Report #JAUSA-28581 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Urea Increased Health Risperdal PS ORAL .5 MG 1 DAILY Condition Aggravated Professional Date:03/12/98ISR Number: 3129121-0Report Type:Periodic Company Report #JAUSA-28614 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Health Risperdal PS ORAL Professional Date:03/12/98ISR Number: 3129557-8Report Type:Periodic Company Report #JAUSA-28009 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS ORAL 9 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3129560-8Report Type:Periodic Company Report #JAUSA-28010 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 1.5 MG 1 Professional DAILY ORAL Xanax C Restoril C Prozac C Date:03/12/98ISR Number: 3129561-XReport Type:Periodic Company Report #JAUSA-28012 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 3 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3129563-3Report Type:Periodic Company Report #JAUSA-28013 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal PS Janssen ORAL 6 MG DAILY Decreased Professional ORAL Date:03/12/98ISR Number: 3129564-5Report Type:Periodic Company Report #JAUSA-26317 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Risperdal PS ORAL ORAL Oedema Professional Lasix C Zantac C 22-Feb-2006 08:20 AM Page: 77 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3129566-9Report Type:Periodic Company Report #JAUSA-28015 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal PS Janssen ORAL 2 MG DAILY Decreased Professional ORAL Date:03/12/98ISR Number: 3129567-0Report Type:Periodic Company Report #JAUSA-26318 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Health Risperdal PS Janssen ORAL .5 MG 1 DAILY Oedema Peripheral Professional ORAL Paxil C Ativan C Lotensin C Vitamin B12 C Date:03/12/98ISR Number: 3129570-0Report Type:Periodic Company Report #JAUSA-26319 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Menstrual Disorder Consumer Risperdal PS Janssen ORAL 8 MG DAILY ORAL Date:03/12/98ISR Number: 3129571-2Report Type:Periodic Company Report #JAUSA-26322 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS ORAL .5 MG DAILY Fall Professional ORAL Gait Disturbance Prozac C Date:03/12/98ISR Number: 3129574-8Report Type:Periodic Company Report #JAUSA-28017 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal PS Janssen ORAL DAILY ORAL Decreased Professional Haldol C Date:03/12/98ISR Number: 3129575-XReport Type:Periodic Company Report #JAUSA-26332 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Health Risperdal PS Janssen ORAL DAILY ORAL Professional Date:03/12/98ISR Number: 3129577-3Report Type:Periodic Company Report #JAUSA-28018 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Consumer Risperdal PS Janssen ORAL 6 MG 1 DAILY Decreased ORAL Cogentin C 22-Feb-2006 08:20 AM Page: 78 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3129578-5Report Type:Periodic Company Report #JAUSA-26333 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Dermatitis Professional ORAL- 3 MG 2 Muscle Contractions DAILY ORSL- 2 Involuntary MG 2 DAILY Skin Striae ORAL 12 WK Weight Increased Date:03/12/98ISR Number: 3129581-5Report Type:Periodic Company Report #JAUSA-28019 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Risperdal PS Janssen ORAL 12 MG DAILY Professional ORAL Prozac C Date:03/12/98ISR Number: 3129582-7Report Type:Periodic Company Report #JAUSA-26335 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal PS Janssen ORAL 2 MG DAILY Weight Increased ORAL Date:03/12/98ISR Number: 3129584-0Report Type:Periodic Company Report #JAUSA-28022 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal PS Janssen ORAL 4 MG 1 DAILY Decreased Professional ORAL Cogentin C Date:03/12/98ISR Number: 3129585-2Report Type:Periodic Company Report #JAUSA-26336 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal PS Janssen ORAL 8 MG DAILY Deficit/Hyperactivity Professional ORAL Disorder Zyprexa C Dyskinesia Zoloft C Date:03/12/98ISR Number: 3129587-6Report Type:Periodic Company Report #JAUSA-26338 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Consumer Risperdal PS Janssen ORAL 4 MG DAILY ORAL Date:03/12/98ISR Number: 3129588-8Report Type:Periodic Company Report #JAUSA-28026 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Health Risperdal PS ORAL DAILY, ORAL Professional Desipramine C 22-Feb-2006 08:20 AM Page: 79 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3129590-6Report Type:Periodic Company Report #JAUSA-26340 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Health Risperdal PS Janssen ORAL 3 MG 1 DAILY Weight Increased Professional ORAL-.5 MG 2 DAILY ORAL Depakote C Date:03/12/98ISR Number: 3129591-8Report Type:Periodic Company Report #JAUSA-28030 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal PS Janssen ORAL DAILY ORAL Decreased Professional Date:03/12/98ISR Number: 3129593-1Report Type:Periodic Company Report #JAUSA-26343 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Health Risperdal PS Janssen ORAL DAILY ORAL Involuntary Professional Lithium C Inderal C Date:03/12/98ISR Number: 3129594-3Report Type:Periodic Company Report #JAUSA-28034 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 4 MG 3 DAILY Professional ORAL Date:03/12/98ISR Number: 3129596-7Report Type:Periodic Company Report #JAUSA-28036 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Study Risperdal PS Janssen ORAL 2 MG DAILY Initial or Prolonged Tooth Disorder Health ORAL Professional Depakote C Klonokin C Cogentin C Synthroid C Lithium C Date:03/12/98ISR Number: 3129599-2Report Type:Periodic Company Report #JAUSA-28039 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Abnormal Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3129601-8Report Type:Periodic Company Report #JAUSA-28040 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Death Embolism Study Life-Threatening Health 22-Feb-2006 08:20 AM Page: 80 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal PS Janssen ORAL 6 MG DAILY ORAL Prolixin C Cogentin C Glipizide C Fluphenazine C Furosemide C Lotensin C Date:03/12/98ISR Number: 3129603-1Report Type:Periodic Company Report #JAUSA-28041 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Consumer Risperdal PS ORAL ORAL Date:03/12/98ISR Number: 3129606-7Report Type:Periodic Company Report #JAUSA-28042 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Study Risperdal PS Janssen ORAL 6 MG 2 DAILY Initial or Prolonged Confusional State Health ORAL Gait Disturbance Professional Prozac C Goitre Thorazine C Hypercalcaemia Ativan C Lithium C Tegretol C Caladryl C Date:03/12/98ISR Number: 3129609-2Report Type:Periodic Company Report #JAUSA-28045 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal PS Janssen ORAL 4MG DAILY Initial or Prolonged Drug Effect Increased Professional ORAL Suicide Attempt Cogentin C Date:03/12/98ISR Number: 3129612-2Report Type:Periodic Company Report #JAUSA-28066 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Consumer Risperdal PS Janssen ORAL 3 MG ORAL Fatigue Paxil C Flushing Laboratory Test Abnormal Leukocytosis Menorrhagia Sedation Weight Increased 22-Feb-2006 08:20 AM Page: 81 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3129615-8Report Type:Periodic Company Report #JAUSA-28068 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal PS Janssen ORAL 7 MG DAILY Crying ORAL Lithobid C Buspar C Paxil C Synthroid C Cardizem C Date:03/12/98ISR Number: 3129682-1Report Type:Periodic Company Report #JAUSA-26347 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Deficit/Hyperactivity Professional ORAL Disorder Extrapyramidal Disorder Date:03/12/98ISR Number: 3129686-9Report Type:Periodic Company Report #JAUSA-26353 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Diarrhoea Professional ORAL Dizziness Dry Mouth Nausea Weight Increased Date:03/12/98ISR Number: 3129688-2Report Type:Periodic Company Report #JAUSA-26354 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Risperdal PS Janssen ORAL 5 MG DAILY Condition Aggravated Professional ORAL Galactorrhoea Ativan C Hyperprolactinaemia Date:03/12/98ISR Number: 3129691-2Report Type:Periodic Company Report #JAUSA-26357 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal PS Janssen ORAL 5 MG DAILY Hyperprolactinaemia Professional ORAL- 1 MG DAILY ORAL Date:03/12/98ISR Number: 3129706-1Report Type:Periodic Company Report #JAUSA-26366 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Risperdal PS Janssen ORAL 2MG DAILY Condition Aggravated Professional ORAL Speech Disorder Zoloft C Amantadine C 22-Feb-2006 08:20 AM Page: 82 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3129708-5Report Type:Periodic Company Report #JAUSA-26367 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertrophy Breast Health Risperdal PS Janssen ORAL DAILY ORAL Professional Tegretol C Date:03/12/98ISR Number: 3129710-3Report Type:Periodic Company Report #JAUSA-26376 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Risperdal PS Janssen ORAL DAILY ORAL Professional Date:03/12/98ISR Number: 3129711-5Report Type:Periodic Company Report #JAUSA-26362 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Consumer Risperdal PS Janssen ORAL DAILY ORAL Date:03/12/98ISR Number: 3130401-3Report Type:Periodic Company Report #JAUSA-26081 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Health Risperdal PS Janssen ORAL 2 MG DAILY Muscular Weakness Professional ORAL Depakote C Artane C Date:03/12/98ISR Number: 3130404-9Report Type:Periodic Company Report #JAUSA-26082 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Consumer Risperdal PS Janssen ORAL 2 MG DAILY Weight Increased ORAL Lithium C Date:03/12/98ISR Number: 3130408-6Report Type:Periodic Company Report #JAUSA-26083 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Consumer Risperdal PS Janssen ORAL 6 MG DAILY Hyperprolactinaemia ORAL Lithium C Date:03/12/98ISR Number: 3130411-6Report Type:Periodic Company Report #JAUSA-26084 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal PS Janssen ORAL 3 MG 1 DAILY Erectile Dysfunction Professional ORAL 22-Feb-2006 08:20 AM Page: 83 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3130414-1Report Type:Periodic Company Report #JAUSA-26085 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal PS Janssen ORAL 1 MG 3 DAILY Hyperprolactinaemia Professional ORAL Weight Increased Depakote C Date:03/12/98ISR Number: 3130418-9Report Type:Periodic Company Report #JAUSA-26086 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal PS ORAL 1 MG 3 DAILY Hyperprolactinaemia Professional ORAL Weight Increased Depakote C Benadryl C Ritalin C Zoloft C Guanfacine C Date:03/12/98ISR Number: 3130423-2Report Type:Periodic Company Report #JAUSA-26087 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal PS Janssen ORAL DAILY ORAL 4 WK Insomnia Xanax C Paranoia Date:03/12/98ISR Number: 3130426-8Report Type:Periodic Company Report #JAUSA-26089 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3130430-XReport Type:Periodic Company Report #JAUSA-26093 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL DAILY ORAL Galactorrhoea Professional Hyperprolactinaemia Date:03/12/98ISR Number: 3130435-9Report Type:Periodic Company Report #JAUSA-26096 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Risperdal PS Janssen ORAL 6 MG DAILY Libido Decreased Professional ORAL; 4 MG DAILY ORAL 22-Feb-2006 08:20 AM Page: 84 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3130440-2Report Type:Periodic Company Report #JAUSA-26098 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Risperdal PS Janssen ORAL 6 MG DAILY Libido Decreased Professional ORAL, 3 MG DAILY ORAL Date:03/12/98ISR Number: 3130444-XReport Type:Periodic Company Report #JAUSA-26099 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Risperdal PS Janssen ORAL 6 MG DAILY Libido Decreased Professional ORAL Date:03/12/98ISR Number: 3130448-7Report Type:Periodic Company Report #JAUSA-26102 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blepharospasm Health Risperdal PS Janssen ORAL DAILY ORAL; Tardive Dyskinesia Professional .5 MG DAILY ORAL Prozac C Tofranil C Date:03/12/98ISR Number: 3130454-2Report Type:Periodic Company Report #JAUSA-26104 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY Attention ORAL Deficit/Hyperactivity Lithium C Disorder Insomnia Date:03/12/98ISR Number: 3130456-6Report Type:Periodic Company Report #JAUSA-26105 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal PS Janssen ORAL .5 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3130460-8Report Type:Periodic Company Report #JAUSA-26107 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sleep Walking Health Risperdal PS Janssen ORAL 3 MG DAILY Professional ORAL; 1MG IN AM, 2 MG HS Date:03/12/98ISR Number: 3130464-5Report Type:Periodic Company Report #JAUSA-26108 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Health Risperdal PS Janssen ORAL 1 MG DAILY Professional ORAL 22-Feb-2006 08:20 AM Page: 85 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vasotec C Lasix C Date:03/12/98ISR Number: 3130468-2Report Type:Periodic Company Report #JAUSA-26110 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Discharge Health Risperdal PS Janssen ORAL 2 MG DAILY Electrocardiogram Professional ORAL Abnormal Tegretol SS ORAL DAILY ORAL Gynaecomastia Zoloft C Date:03/12/98ISR Number: 3130474-8Report Type:Periodic Company Report #JAUSA-26111 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS ORAL 6 MG DAILY Dermatitis Professional ORAL;3 MG Tremor DAILY; 4 MG DAILY 10 WK Luvox C Date:03/12/98ISR Number: 3130478-5Report Type:Periodic Company Report #JAUSA-26112 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL DAILY ORAL Hyperprolactinaemia Professional Date:03/12/98ISR Number: 3130483-9Report Type:Periodic Company Report #JAUSA-25982 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperdal PS Janssen ORAL 8 MG DAILY, Thinking Abnormal ORAL Date:03/12/98ISR Number: 3130489-XReport Type:Periodic Company Report #JAUSA-25999 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY ORAL Haldol (Haloperidol) C Zoloft (Sertraline) C Date:03/12/98ISR Number: 3130495-5Report Type:Periodic Company Report #JAUSA-26001 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Below Health Risperdal PS ORAL 2 MG 2 DAILY Therapeutic Professional ORAL; 2 MG 1 DAILY ORAL; 1MG 2 DAILY ORAL Depakote SS ORAL 1050 MG DAILY 22-Feb-2006 08:20 AM Page: 86 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL: 50 MG IN A.M. 1000 MG HS. Fluoxetine SS ORAL 1O MG 1 DAILY ORAL Date:03/12/98ISR Number: 3130499-2Report Type:Periodic Company Report #JAUSA-26002 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS ORAL 2.5 MG 1 Condition Aggravated DAILY ORAL; Sedation 3.5 MG 1 Weight Increased DAILY ORAL; 3 MG 1 DAILY Date:03/12/98ISR Number: 3130503-1Report Type:Periodic Company Report #JAUSA-26007 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Risperdal PS Janssen ORAL 1 MG DAILY Dyspnoea Professional ORAL AT BEDTIME; 2 MG DAILY ORAL AT BEDTIME Date:03/12/98ISR Number: 3130505-5Report Type:Periodic Company Report #JAUSA-26009 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Risperdal PS Janssen ORAL ORAL 1 WK Tachycardia Professional Date:03/12/98ISR Number: 3130510-9Report Type:Periodic Company Report #JAUSA-26010 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY ORAL; 5 MG 2 DAILY ORAL; 4 MG 2 DAILY ORAL 8 WK Cogentin (Benzotropine) C Klonopin (Clonazepam) C Vasotec (Enalapril) C Date:03/12/98ISR Number: 3130513-4Report Type:Periodic Company Report #JAUSA-26013 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS Janssen ORAL ORAL Keratoconjunctivitis Sicca Weight Increased 22-Feb-2006 08:20 AM Page: 87 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3130517-1Report Type:Periodic Company Report #JAUSA-26064 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Consumer Risperdal PS Janssen ORAL 1 MG DIALY Involuntary ORAL Lithium (Lithium) C Date:03/12/98ISR Number: 3130521-3Report Type:Periodic Company Report #JAUSA-26065 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL DAILY ORAL Hyperprolactinaemia Professional Date:03/12/98ISR Number: 3130526-2Report Type:Periodic Company Report #JAUSA-26066 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pain In Extremity Consumer Risperdal PS Janssen ORAL 2 MG DAILY ORAL; 3 MG DAILY ORAL Dalmane (Flurazepam) C Benadryl (Diphenhydramine) C Date:03/12/98ISR Number: 3130530-4Report Type:Periodic Company Report #JAUSA-26067 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspepsia Consumer Risperdal PS Janssen ORAL 1 MG DAILY ORAL Date:03/12/98ISR Number: 3130535-3Report Type:Periodic Company Report #JAUSA-26068 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Euphoric Mood Consumer Risperdal PS Janssen ORAL DAILY ORAL Initial or Prolonged Effexor SS ORAL 5-6 TABLETS DAILY ORAL Buspar (Buspirone) C Date:03/12/98ISR Number: 3130541-9Report Type:Periodic Company Report #JAUSA-26069 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS Janssen ORAL 4 MG DAILY Hyperprolactinaemia ORAL Sedation Date:03/12/98ISR Number: 3130544-4Report Type:Periodic Company Report #JAUSA-26071 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 3 MG DAILY Leukopenia Professional ORAL 22-Feb-2006 08:20 AM Page: 88 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Artane C Lithium C Buspar C Clonopin C Date:03/12/98ISR Number: 3130545-6Report Type:Periodic Company Report #JAUSA-26072 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Risperdal PS ORAL 1 MG DAILY ORAL Depakote C Serzone C Date:03/12/98ISR Number: 3130583-3Report Type:Periodic Company Report #JAUSA-26075 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL 3 MG DAILY Hyperprolactinaemia Professional ORAL Date:03/12/98ISR Number: 3130586-9Report Type:Periodic Company Report #JAUSA-26078 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicide Attempt Health Risperdal PS Janssen ORAL ORAL Professional Paxil SS ORAL ORAL Date:03/12/98ISR Number: 3130590-0Report Type:Periodic Company Report #JAUSA-26079 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal PS Janssen ORAL 4 MG DAILY Deficit/Hyperactivity Professional ORAL Disorder Ativan C Depakote C Date:03/12/98ISR Number: 3130592-4Report Type:Periodic Company Report #JAUSA-26080 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Amylase Increased Health Risperdal PS Janssen ORAL DAILY ORAL Professional Lithium C Date:03/12/98ISR Number: 3130597-3Report Type:Periodic Company Report #JAUSA-26113 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL DAILY ORAL Lithium (Lithium) C Prozac (Fluoxetine) C 22-Feb-2006 08:20 AM Page: 89 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3130601-2Report Type:Periodic Company Report #JAUSA-26114 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3130604-8Report Type:Periodic Company Report #JAUSA-26167 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Risperdal Initial or Prolonged Respiratory Failure Professional (Risperidone) PS ORAL 2 MG DAILY ORAL Prozac (Fluoxetine) C Xanax (Alprazolam) C Date:03/12/98ISR Number: 3130608-5Report Type:Periodic Company Report #JAUSA-26187 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Risperdal Convulsion Professional (Risperidone) PS ORAL .5 MG 2 DAILY Hyponatraemia ORAL Date:03/12/98ISR Number: 3130610-3Report Type:Periodic Company Report #JAUSA-26200 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Risperdal Initial or Prolonged Professional (Risperidone) PS Janssen ORAL 1 MG DAILY ORAL Sudafed (Pseudoephedrine) SS ORAL ORAL Date:03/12/98ISR Number: 3130613-9Report Type:Periodic Company Report #JAUSA-26203 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperedal Professional (Risperidone) PS Janssen ORAL DAILY ORAL Date:03/12/98ISR Number: 3130617-6Report Type:Periodic Company Report #JAUSA-26210 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Health Risperdal Initial or Prolonged Ketoacidosis Professional (Risperidone) PS Janssen ORAL 6 MG DAILY Pancreatitis ORAL Renal Failure Acute Depakote (Valproate Rhabdomyolysis Sodium) C Ativan (Lorazepam) C 22-Feb-2006 08:20 AM Page: 90 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3130621-8Report Type:Periodic Company Report #JAUSA-26213 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Depakote (Valproate Sodium) C Zyprexa (Olanzapine) C Prozac (Fluoxetine) C Date:03/12/98ISR Number: 3130624-3Report Type:Periodic Company Report #JAUSA-26214 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Professional (Risperidone) PS ORAL 3 MG DAILY ORAL Xanax (Alprazolam) C Zoloft (Sertraline) C Anafranil (Clomipramine) C Date:03/12/98ISR Number: 3130627-9Report Type:Periodic Company Report #JAUSA-26215 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Headache (Risperidone) PS ORAL 1 MG DAILY Sedation ORAL Tremor Synthroid (Levothyroxine) C Date:03/12/98ISR Number: 3130629-2Report Type:Periodic Company Report #JAUSA-26217 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Risperdal Professional (Risperidone) PS Janssen ORAL 1.5 MG DAILY ORAL Depakote (Valproate Sodium) C Effexor (Venlafexine) C Date:03/12/98ISR Number: 3130632-2Report Type:Periodic Company Report #JAUSA-26219 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal Professional (Risperidone) PS ORAL 1 MG 2 DAILY ORAL Tegretol (Carbamazepine) C 22-Feb-2006 08:20 AM Page: 91 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3130636-XReport Type:Periodic Company Report #JAUSA-26220 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Health Risperdal Urinary Incontinence Professional (Risperidone) PS Janssen ORAL DAILY ORAL Date:03/12/98ISR Number: 3130639-5Report Type:Periodic Company Report #JAUSA-26221 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thinking Abnormal Health Risperdal Professional (Risperidone) PS Janssen ORAL 8 MG DAILY ORAL Paxil (Paroxetine) C Date:03/12/98ISR Number: 3130642-5Report Type:Periodic Company Report #JAUSA-26232 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bleeding Time Prolonged Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG DAILY ORAL Lithuim (Lithium) C Desipramine (Desipramine) C Date:03/12/98ISR Number: 3130644-9Report Type:Periodic Company Report #JAUSA-26255 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Risperdal Phosphokinase Increased Professional (Risperidone) PS Janssen ORAL 3 MG DAILY Malaise ORAL Lithium (Lithium) C Wellbutrin (Amfebutamone) C Klonopin (Clonazepam) C Date:03/12/98ISR Number: 3130646-2Report Type:Periodic Company Report #JAUSA-26276 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Paranoia (Risperidone) PS Janssen ORAL 6 MG DAILY ORAL Date:03/12/98ISR Number: 3130649-8Report Type:Periodic Company Report #JAUSA-26293 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL, ONLY RECEIVED 2 DOSES, ONE IN 22-Feb-2006 08:20 AM Page: 92 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PM AND ONE IN Valium (Diazepam) C Benedryl (Diphenhydramine) C Nicardipine (Nicardipine) C Theophylline (Theophylline) C Date:03/12/98ISR Number: 3130650-4Report Type:Periodic Company Report #JAUSA-26314 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Paxil (Paroxetine) C Date:03/12/98ISR Number: 3130652-8Report Type:Periodic Company Report #JAUSA-26316 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Consumer Risperdal Insomnia (Risperidone) PS Janssen ORAL 4 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3131373-8Report Type:Periodic Company Report #JAUSA-26457 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertrophy Breast Health Risperdal PS Janssen ORAL DAILY, ORAL Professional Date:03/12/98ISR Number: 3131375-1Report Type:Periodic Company Report #JAUSA-26459 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL 6 MG, DAILY, Hyperprolactinaemia Professional ORAL Muscle Contractions Cogentin C Involuntary Date:03/12/98ISR Number: 3131383-0Report Type:Periodic Company Report #JAUSA-26462 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Engorgement Health Risperal PS Janssen ORAL 2 MG, D Breast Pain Professional DAILY, ORAL Galactorrhoea Date:03/12/98ISR Number: 3131386-6Report Type:Periodic Company Report #JAUSA-26463 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal PS Janssen ORAL DAILY, ORAL Professional 22-Feb-2006 08:20 AM Page: 93 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3131404-5Report Type:Periodic Company Report #JAUSA-26464 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tooth Malformation Consumer Risperdal (Risperidone) PS Janssen ORAL 2 MG 2 DAILY, ORAL; TABLET Tegretol C Neurontin C Date:03/12/98ISR Number: 3131415-XReport Type:Periodic Company Report #JAUSA-26466 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 2 MG DAILY , ORAL 3 DAY Date:03/12/98ISR Number: 3131418-5Report Type:Periodic Company Report #JAUSA-26469 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperdal PS Janssen ORAL 3 MG 3 DAILY, ORAL 4 YR Date:03/12/98ISR Number: 3131424-0Report Type:Periodic Company Report #JAUSA-26472 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3131437-9Report Type:Periodic Company Report #JAUSA-26478 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 6 MG, DAILY, ORAL Depakote C Date:03/12/98ISR Number: 3132194-2Report Type:Periodic Company Report #JAUSA-26382 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polyuria Health Risperdal PS Janssen ORAL ORAL Thirst Professional Date:03/12/98ISR Number: 3132198-XReport Type:Periodic Company Report #JAUSA-26383 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urticaria Health Risperdal PS Janssen ORAL 1MG 2 DAILY Professional ORAL Clonidine C 22-Feb-2006 08:20 AM Page: 94 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3132201-7Report Type:Periodic Company Report #JAUSA-26384 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal PS Janssen ORAL .5MG 2 DAILY Confusional State Professional ORAL Prothrombin Level Coumadin C Increased Flagyl C Sedation Pamelor C Ofloxacin C Cipro C Periactin C Lasix C Lactulose C Zantac C Date:03/12/98ISR Number: 3132205-4Report Type:Periodic Company Report #JAUSA-26388 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal PS Janssen ORAL 6MG DAILY Sedation Professional ORAL Depakote SS ORAL -,DAILY ORAL Clonopin (Clonazepam) C Date:03/12/98ISR Number: 3132208-XReport Type:Periodic Company Report #JAUSA-26390 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL -, ORAL Hyperprolactinaemia Professional Date:03/12/98ISR Number: 3132211-XReport Type:Periodic Company Report #JAUSA-26393 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL 6MG 1 DAILY Hyperprolactinaemia Professional ORAL, 3MG DAILY ORAL Date:03/12/98ISR Number: 3132215-7Report Type:Periodic Company Report #JAUSA-26394 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal PS Janssen ORAL 2MG 2 DAILY Professional ORAL Haldol C Clonazepam C Zoloft C Date:03/12/98ISR Number: 3132218-2Report Type:Periodic Company Report #JAUSA-26395 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL 5MG DAILY Professional ORAL 22-Feb-2006 08:20 AM Page: 95 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3132222-4Report Type:Periodic Company Report #JAUSA-26396 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL 5MG DAILY Professional ORAL 18 MON Date:03/12/98ISR Number: 3132224-8Report Type:Periodic Company Report #JAUSA-26397 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Risperdal PS Janssen ORAL 2.5 MG DAILY Professional ORAL Loxitane C Amitriptyline C Premarin C Vitamin E C Lasix C Ditropan C Baclofen C Nitrofurantoin C Date:03/12/98ISR Number: 3132227-3Report Type:Periodic Company Report #JAUSA-26399 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Consumer Risperdal PS Janssen ORAL 1MG DAILY Weight Increased ORAL Date:03/12/98ISR Number: 3132229-7Report Type:Periodic Company Report #JAUSA-26400 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL 3MG DAILY Professional ORAL SEC Estrogens C Depakote C Date:03/12/98ISR Number: 3132232-7Report Type:Periodic Company Report #JAUSA-26401 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Health Risperdal PS Janssen ORAL 4MG DAILY Emotional Disorder Professional ORAL Nervousness Haldol C Visual Disturbance Lithium C Tegretol C Date:03/12/98ISR Number: 3132234-0Report Type:Periodic Company Report #JAUSA-26402 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhinitis Health Risperdal PS Janssen ORAL 2MG DAILY Professional ORAL 22-Feb-2006 08:20 AM Page: 96 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3132236-4Report Type:Periodic Company Report #JAUSA-26421 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depersonalisation Consumer Risperdal PS Janssen ORAL 3MG DAILY Visual Disturbance ORAL, TABLET Risperdal SS Janssen ORAL 3ML DAILY ORAL, SOLUTION Date:03/12/98ISR Number: 3132237-6Report Type:Periodic Company Report #JAUSA-26430 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal PS Janssen ORAL -, DAILY ORAL, TABLET Risperdal SS Janssen ORAL .15ML DAILY ORAL, SOLUTION Depakene C Date:03/12/98ISR Number: 3132238-8Report Type:Periodic Company Report #JAUSA-26443 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Health Risperdal PS Janssen ORAL -, DAILY ORAL Professional Depakote C Date:03/12/98ISR Number: 3132240-6Report Type:Periodic Company Report #JAUSA-26444 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal PS Janssen ORAL -, DAILY ORAL Condition Aggravated Date:03/12/98ISR Number: 3132242-XReport Type:Periodic Company Report #JAUSA-26454 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal PS Janssen ORAL -, DAILY ORAL Salivary Hypersecretion Thinking Abnormal Date:03/12/98ISR Number: 3132244-3Report Type:Periodic Company Report #JAUSA-26456 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL -, DAILY ORAL Professional Date:03/12/98ISR Number: 3134483-4Report Type:Periodic Company Report #JAUSA-27807 Age:62 YR Gender:Female I/FU:I Outcome PT Other Condition Aggravated Insomnia 22-Feb-2006 08:20 AM Page: 97 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Malaise Report Source Product Role Manufacturer Route Dose Duration Health Risperdal Professional (Risperidone) PS Janssen ORAL 3 MG DAILY DAILY ORAL Date:03/12/98ISR Number: 3134484-6Report Type:Periodic Company Report #JAUSA-27808 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Confusional State Professional (Risperidone) PS Janssen ORAL 1- 2 MG DAILY Hallucination ORAL 1 MON Nausea Glyburide C Vomiting Glucophage C Lopid C Date:03/12/98ISR Number: 3134485-8Report Type:Periodic Company Report #JAUSA-27811 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal Decreased Professional (Risperidone) PS Janssen ORAL TABLET 3 MG DAILY ORAL Date:03/12/98ISR Number: 3134486-XReport Type:Periodic Company Report #JAUSA-27813 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal Decreased Professional (Risperidone) PS Janssen ORAL TABLET 1 MG 2 DAILY ORAL 10 DAY Albuterol C Beclomethasone C Date:03/12/98ISR Number: 3134487-1Report Type:Periodic Company Report #JAUSA-27814 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypokinesia Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET 3 MG DAILY ORAL Date:03/12/98ISR Number: 3134488-3Report Type:Periodic Company Report #JAUSA-27818 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Study Risperdal Initial or Prolonged Nausea Health (Risperidone) PS Janssen ORAL 3 MG 2 DAILY Oedema Peripheral Professional ORAL Vomiting Insulin, Nph C Insulin, Regular C 22-Feb-2006 08:20 AM Page: 98 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3134489-5Report Type:Periodic Company Report #JAUSA-27826 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal Decreased Professional (Risperidone) PS Janssen ORAL TABLET, ORAL Date:03/12/98ISR Number: 3134490-1Report Type:Periodic Company Report #JAUSA-27834 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Above Health Risperdal(Risperidon Initial or Prolonged Therapeutic Professional e) PS Janssen ORAL TABLET, ORAL Neuroleptic Malignant Lithium C Syndrome Date:03/12/98ISR Number: 3134491-3Report Type:Periodic Company Report #JAUSA-27842 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Professional (Risperidone) PS Janssen ORAL SEE IMAGE 6 MON Date:03/12/98ISR Number: 3134492-5Report Type:Periodic Company Report #JAUSA-27845 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone) PS Janssen ORAL TABLET, 1 MG 1 DAILY ORAL Date:03/12/98ISR Number: 3134493-7Report Type:Periodic Company Report #JAUSA-27846 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone) PS Janssen ORAL SEE IMAGE Date:03/12/98ISR Number: 3134563-3Report Type:Periodic Company Report #JAUSA-27848 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone) PS Janssen ORAL SEE IMAGE Date:03/12/98ISR Number: 3134564-5Report Type:Periodic Company Report #JAUSA-27849 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone) PS Janssen ORAL TABLET, 6 MG DAILY ORAL 22-Feb-2006 08:20 AM Page: 99 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3134565-7Report Type:Periodic Company Report #JAUSA-27850 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone) PS Janssen ORAL TABLET, 3 MG DAILY ORAL Date:03/12/98ISR Number: 3134569-4Report Type:Periodic Company Report #JAUSA-27852 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone) PS Janssen ORAL TABLET, DAILY ORAL Date:03/12/98ISR Number: 3134570-0Report Type:Periodic Company Report #JAUSA-27854 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sleep Disorder Consumer Risperdal (Risperidone) PS Janssen ORAL TABLET, 3 MG DAILY ORAL Date:03/12/98ISR Number: 3134572-4Report Type:Periodic Company Report #JAUSA-27855 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone) PS Janssen ORAL TABLET, 4 MG DAILY ORAL Date:03/12/98ISR Number: 3134574-8Report Type:Periodic Company Report #JAUSA-27857 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Risperdal Professional (Risperidone) PS Janssen ORAL 2 MG 3 DAILY ORAL Zoloft C Date:03/12/98ISR Number: 3134575-XReport Type:Periodic Company Report #JAUSA-27859 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Professional (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3134581-5Report Type:Periodic Company Report #JAUSA-27943 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 3 MG 3 DAILY Professional ORAL 25 WK Luvox C 22-Feb-2006 08:20 AM Page: 100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3134583-9Report Type:Periodic Company Report #JAUSA-27945 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Professional ORAL Stezaline C Prozac C Date:03/12/98ISR Number: 3134585-2Report Type:Periodic Company Report #JAUSA-27947 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 9 MG DAILY Professional ORAL Effexor C Date:03/12/98ISR Number: 3134587-6Report Type:Periodic Company Report #JAUSA-27949 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal PS Janssen ORAL 2 MG 2 DAILY Decreased Professional ORAL Date:03/12/98ISR Number: 3134591-8Report Type:Periodic Company Report #JAUSA-27952 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Effect Decreased Health Risperdal PS Janssen ORAL 2 MG 3 DAILY Professional ORAL Date:03/12/98ISR Number: 3134593-1Report Type:Periodic Company Report #JAUSA-27954 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Risperdal PS Janssen ORAL 3 MG 1 DAILY Professional ORAL Date:03/12/98ISR Number: 3134595-5Report Type:Periodic Company Report #JAUSA-27955 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Hallucination Professional ORAL Date:03/12/98ISR Number: 3134596-7Report Type:Periodic Company Report #JAUSA-27956 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Risperdal PS Janssen ORAL 4.5 MG 1 Professional DAILY ORAL AT BED TIME 22-Feb-2006 08:20 AM Page: 101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3134598-0Report Type:Periodic Company Report #JAUSA-27957 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Health Risperdal PS Janssen ORAL 1 MG 2 DAILY, Professional ORAL Zoloft C Surmontil C Date:03/12/98ISR Number: 3134600-6Report Type:Periodic Company Report #JAUSA-27960 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Pain Health Risperdal PS Janssen ORAL 2 MG 1 DAILY Bruxism Professional AT BEDTIME Gynaecomastia Date:03/12/98ISR Number: 3134611-0Report Type:Periodic Company Report #JAUSA-27962 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Health Risperdal PS Janssen ORAL 3 MG 1 DAILY Professional ORAL AT BEDTIME Date:03/12/98ISR Number: 3134613-4Report Type:Periodic Company Report #JAUSA-27963 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Health Risperdal PS Janssen ORAL 6 MG DAILY Professional ORAL (2MG AM AND 4 MG AT BEDTIME) Date:03/12/98ISR Number: 3134615-8Report Type:Periodic Company Report #JAUSA-27965 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS ORAL -, 1 DAILY Hyperprolactinaemia Professional ORAL Triphasil C Date:03/12/98ISR Number: 3134617-1Report Type:Periodic Company Report #JAUSA-27967 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dry Skin Consumer Risperdal PS Janssen ORAL -. DAILY ORAL Initial or Prolonged Flushing Hyperhidrosis Tachycardia 22-Feb-2006 08:20 AM Page: 102 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3134619-5Report Type:Periodic Company Report #JAUSA-27969 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Consumer Risperdal PS Janssen ORAL -, DAILY ORAL Initial or Prolonged Date:03/12/98ISR Number: 3134621-3Report Type:Periodic Company Report #JAUSA-27972 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Health Risperdal PS Janssen ORAL 3 MG 1 DAILY Professional ORAL AT BED TIME Nortriptypline C Glucotrol C Cortone Acetate C Date:03/12/98ISR Number: 3134623-7Report Type:Periodic Company Report #JAUSA-27973 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal PS Janssen ORAL -, ORAL Dyskinesia Parnate C Weight Increased Unspecified C Date:03/12/98ISR Number: 3134625-0Report Type:Periodic Company Report #JAUSA-27975 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Consumer Risperdal PS Janssen ORAL 1 MG 2 DAILY Vomiting ORAL Mellaril C Date:03/12/98ISR Number: 3134627-4Report Type:Periodic Company Report #JAUSA-27979 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epistaxis Health Risperdal PS Janssen .5 MG 3 DAILY Professional ORAL Date:03/12/98ISR Number: 3134713-9Report Type:Periodic Company Report #JAUSA-27860 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Professional ORAL Date:03/12/98ISR Number: 3134719-XReport Type:Periodic Company Report #JAUSA-27861 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Tremor Professional ORAL Elavil C 22-Feb-2006 08:20 AM Page: 103 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3134722-XReport Type:Periodic Company Report #JAUSA-27863 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Consumer Risperdal PS Janssen ORAL 12 MG DAILY Weight Increased ORAL Date:03/12/98ISR Number: 3134725-5Report Type:Periodic Company Report #JAUSA-27864 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Consumer Risperdal PS Janssen ORAL ORAL/ 3 MG Hypertonia DAILY Increased Appetite Norpramin C Weight Increased Cogentin C Eskalith C Date:03/12/98ISR Number: 3134728-0Report Type:Periodic Company Report #JAUSA-27865 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3134730-9Report Type:Periodic Company Report #JAUSA-27866 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Risperdal PS ORAL 2 MG 1 DAILY Oedema ORAL Lithium C Date:03/12/98ISR Number: 3134733-4Report Type:Periodic Company Report #JAUSA-27869 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal PS Janssen ORAL 1 MG 2 DAILY Euphoric Mood ORAL Prozac C Trazodone C Date:03/12/98ISR Number: 3134737-1Report Type:Periodic Company Report #JAUSA-27879 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Consumer Risperdal PS Janssen ORAL 1 MG 3 DAILY Muscle Contractions ORAL Involuntary Wellbutrin C Date:03/12/98ISR Number: 3134739-5Report Type:Periodic Company Report #JAUSA-27880 Age:44 YR Gender:Female I/FU:I Outcome PT Other Condition Aggravated Disturbance In Attention Muscle Contractions 22-Feb-2006 08:20 AM Page: 104 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Involuntary Urinary Retention Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal PS Jannssen ORAL 3 MG 1 DAILY ORAL Macrodantin C Date:03/12/98ISR Number: 3134743-7Report Type:Periodic Company Report #JAUSA-27882 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3134745-0Report Type:Periodic Company Report #JAUSA-27884 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal PS ORAL 2 MG 1 DAILY Professional ORAL Cogentin C Date:03/12/98ISR Number: 3134749-8Report Type:Periodic Company Report #JAUSA-27888 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal PS ORAL 1.5 MG 1 Disturbance In Attention DAILY ORAL Cylert C Tenex C Date:03/12/98ISR Number: 3134750-4Report Type:Periodic Company Report #JAUSA-27892 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Health Risperdal PS ORAL 9 MG 1 DAILY Professional ORAL Lithium C Anafranil C Klonopin C Thyroid C Estrogen Replacement Therapy C Date:03/12/98ISR Number: 3134751-6Report Type:Periodic Company Report #JAUSA-27895 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pigmentation Disorder Health Risperdal PS Janssen ORAL 2 MG 1 DAILY Professional ORAL 22-Feb-2006 08:20 AM Page: 105 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3134752-8Report Type:Periodic Company Report #JAUSA-27896 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Maculo-Papular Health Risperdal PS Janssen ORAL 1 MG SINGLE Vomiting Professional ORAL Lithium C Date:03/12/98ISR Number: 3134753-XReport Type:Periodic Company Report #JAUSA-27898 Age:74 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Consumer Risperdal PS Janssen ORAL 2 MG 1 DAILY Sedation ORAL; .5 MG 1 Tremor DAILY; SEE IMAGE 9 WK Paxil C Corgard C Date:03/12/98ISR Number: 3134754-1Report Type:Periodic Company Report #JAUSA-27899 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL 3 MG 1 DAILY Galactorrhoea Professional ORAL, 2 MG 1 DAILY Paxil C Klonopin C Date:03/12/98ISR Number: 3134755-3Report Type:Periodic Company Report #JAUSA-27901 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Consumer Risperdal PS Janssen ORAL 1 MG 1 DAILY Condition Aggravated ORAL Dilantin C Date:03/12/98ISR Number: 3134756-5Report Type:Periodic Company Report #JAUSA-27902 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Urea Increased Health Risperdal PS Janssen ORAL 6 MG 1 DAILY Professional ORAL Clozapine C Inderal C Cogentin C .. C Date:03/12/98ISR Number: 3134757-7Report Type:Periodic Company Report #JAUSA-27921 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Depression Health Risperdal PS Janssen ORAL 1 MG DAILY Suicide Attempt Professional ORAL Effexor C Wellbutrin C Restoril C 22-Feb-2006 08:20 AM Page: 106 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3134760-7Report Type:Periodic Company Report #JAUSA-26809 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Risperdal PS ORAL -,ORAL 5 DAY Syndrome Professional Date:03/12/98ISR Number: 3134762-0Report Type:Periodic Company Report #JAUSA-26822 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal PS ORAL 6 MG DAILY Professional ORAL Valproic Acid C Lithium C Date:03/12/98ISR Number: 3134763-2Report Type:Periodic Company Report #JAUSA-26877 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS ORAL -,ORAL Galactorrhoea Professional Hyperprolactinaemia Date:03/12/98ISR Number: 3134765-6Report Type:Periodic Company Report #JAUSA-26879 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Risperdal PS Janssen ORAL 2 MG DAILY Professional ORAL Risperdal SS ORAL 1 MG DAILY ORAL Date:03/12/98ISR Number: 3134768-1Report Type:Periodic Company Report #JAUSA-26880 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Risperdal PS Janssen ORAL 5 MG DAILY Professional ORAL; TREATMENT BEGAN IN 1994 Date:03/12/98ISR Number: 3134770-XReport Type:Periodic Company Report #JAUSA-26881 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Risperdal PS Janssen ORAL 2 MG DAILY Professional ORAL Risperdal SS 1 MG DAILY ORAL 22-Feb-2006 08:20 AM Page: 107 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3134771-1Report Type:Periodic Company Report #JAUSA-26883 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Engorgement Consumer Risperdal PS Janssen ORAL Galactorrhoea Metrorrhagia Weight Increased Date:03/12/98ISR Number: 3134774-7Report Type:Periodic Company Report #JAUSA-26884 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Peripheral Ischaemia Health Risperdal PS Janssen ORAL 1 MG DAILY Weight Decreased Professional ORAL Date:03/12/98ISR Number: 3134775-9Report Type:Periodic Company Report #JAUSA-26885 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Risperdal PS Janssen ORAL 6 MG DAILY Initial or Prolonged Condition Aggravated Professional ORAL Psychotic Disorder Depakote C Date:03/12/98ISR Number: 3134777-2Report Type:Periodic Company Report #JAUSA-26888 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Consumer Risperdal PS Janssen ORAL 1 MG DAILY ORAL Congentin C Date:03/12/98ISR Number: 3134779-6Report Type:Periodic Company Report #JAUSA-26890 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal PS Janssen ORAL 6 MG DAILY ORAL Zyprexa SS ORAL DAILY ORAL Lithium C Congentin C Date:03/12/98ISR Number: 3134780-2Report Type:Periodic Company Report #JAUSA-26891 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal PS Janssen ORAL 9 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3134781-4Report Type:Periodic Company Report #JAUSA-26897 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL -DAILY ORAL Professional 22-Feb-2006 08:20 AM Page: 108 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3134783-8Report Type:Periodic Company Report #JAUSA-26898 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Consumer Risperdal PS Janssen ORAL -, DAILY ORAL Tinnitus Prolixin SS ORAL -,DAILY ORAL Clozapine C Cogentin C Date:03/12/98ISR Number: 3134785-1Report Type:Periodic Company Report #JAUSA-26899 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL DAILY ORAL Professional Date:03/12/98ISR Number: 3134786-3Report Type:Periodic Company Report #JAUSA-26900 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polyuria Health Risperdal PS Janssen ORAL -, DAILY ORAL Professional Date:03/12/98ISR Number: 3134788-7Report Type:Periodic Company Report #JAUSA-26903 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polyuria Health Risperdal PS Janssen ORAL -, ORAL Professional Date:03/12/98ISR Number: 3134790-5Report Type:Periodic Company Report #JAUSA-26906 Age:12 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Risperdal PS Janssen ORAL 6 MG DAILY Sedation Professional ORAL Clonopin C Date:03/12/98ISR Number: 3134791-7Report Type:Periodic Company Report #JAUSA-26907 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Suicide Attempt Health Risperdal PS Janssen ORAL -, ORAL Therapeutic Response Professional Decreased Date:03/12/98ISR Number: 3134793-0Report Type:Periodic Company Report #JAUSA-26927 Age:11 YR Gender:Female I/FU:I Outcome PT Other Attention Deficit/Hyperactivity Disorder Disturbance In Attention Fatigue Insomnia 22-Feb-2006 08:20 AM Page: 109 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurosis Sedation Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal PS Janssen ORAL 2 MG 1 DAILY ORAL Date:03/12/98ISR Number: 3135128-XReport Type:Periodic Company Report #JAUSA-27983 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Consumer Risperdal (Risperidone), Janssen, Tablet 4 Mg PS Janssen ORAL 4 MG 2 DAILY ORAL Cogentin C Date:03/12/98ISR Number: 3135130-8Report Type:Periodic Company Report #JAUSA-27984 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG DAILY ORAL Loxapine C Lithium C Cogentin C Date:03/12/98ISR Number: 3135133-3Report Type:Periodic Company Report #JAUSA-27986 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG DAILY ORAL Date:03/12/98ISR Number: 3135135-7Report Type:Periodic Company Report #JAUSA-27988 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG DAILY ORAL Lithium SS Date:03/12/98ISR Number: 3135137-0Report Type:Periodic Company Report #JAUSA-27989 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Risperdal Extrapyramidal Disorder Professional (Risperidone), Sedation Janssen, Tablet PS Janssen ORAL 1.5 MG DAILY ORAL Lithium (Lithium) SS 22-Feb-2006 08:20 AM Page: 110 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3135139-4Report Type:Periodic Company Report #JAUSA-27990 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhinitis Health Risperdal Professional (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY ORAL Oral Contracept. Unsp C Date:03/12/98ISR Number: 3135141-2Report Type:Periodic Company Report #JAUSA-27992 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal Dyspnoea (Risperidone), Fall Janssen, Tablet PS Janssen ORAL 3 MG DAILY Visual Disturbance ORAL Date:03/12/98ISR Number: 3135143-6Report Type:Periodic Company Report #JAUSA-27994 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG DAILY ORAL; 2MG IN AM, 4MG IN PM Prozac C Date:03/12/98ISR Number: 3135145-XReport Type:Periodic Company Report #JAUSA-27995 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3135147-3Report Type:Periodic Company Report #JAUSA-27996 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 12 MG DAILY ORAL Date:03/12/98ISR Number: 3135148-5Report Type:Periodic Company Report #JAUSA-27997 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 6 MG DAILY ORAL 22-Feb-2006 08:20 AM Page: 111 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3135150-3Report Type:Periodic Company Report #JAUSA-27999 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperdal (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 6 MG DAILY ORAL Date:03/12/98ISR Number: 3135153-9Report Type:Periodic Company Report #JAUSA-28003 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG 2 DAILY ORAL Cogentin C Date:03/12/98ISR Number: 3135154-0Report Type:Periodic Company Report #JAUSA-28004 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1.5 MG DAILY ORAL Date:03/12/98ISR Number: 3135155-2Report Type:Periodic Company Report #JAUSA-28005 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 3 MG DAILY ORAL Mellaril C Date:03/12/98ISR Number: 3135156-4Report Type:Periodic Company Report #JAUSA-28007 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Risperdal (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 6 MG DAILY ORAL Date:03/12/98ISR Number: 3135157-6Report Type:Periodic Company Report #JAUSA-27708 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Consumer Risperdal Weight Increased (Risperidone) Janssen Tablet PS Janssen ORAL 6 MG 1 DAILY ORAL Synthroid C 22-Feb-2006 08:20 AM Page: 112 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3135158-8Report Type:Periodic Company Report #JAUSA-27709 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Hyperprolactinaemia (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Lithium C Desipramine C Loestrin C Date:03/12/98ISR Number: 3135159-XReport Type:Periodic Company Report #JAUSA-27710 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - No Adverse Drug Effect Consumer Risperdal Initial or Prolonged (Risperidone), Janssen, Tablet PS Janssen ORAL 4 MG DAILY ORAL Zoloft C Date:03/12/98ISR Number: 3135160-6Report Type:Periodic Company Report #JAUSA-27711 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Consumer Risperdal Flushing (Risperidone), Rhinitis Janssen, Tablet PS Janssen ORAL 2 MG DAILY ORAL Cardura C Imipramine C Xanax C Date:03/12/98ISR Number: 3135163-1Report Type:Periodic Company Report #JAUSA-27713 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Galactorrhoea (Risperidone), Hyperprolactinaemia Janssen, Tablet PS Janssen ORAL ORAL Vomiting Prozac C Ambien C Ortho-Novum C Date:03/12/98ISR Number: 3135165-5Report Type:Periodic Company Report #JAUSA-27714 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Health Risperdal Professional (Risperidone), Janssen, Tablet PS Jannsen ORAL ORAL 22-Feb-2006 08:20 AM Page: 113 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3135167-9Report Type:Periodic Company Report #JAUSA-27715 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Menstrual Disorder Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG DAILY ORAL Date:03/12/98ISR Number: 3135168-0Report Type:Periodic Company Report #JAUSA-27719 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Anxiety (Risperidone), Depression Janssen, Tablet PS Janssen ORAL 1 MG 2 DAILY Fatigue ORAL Malaise Date:03/12/98ISR Number: 3135170-9Report Type:Periodic Company Report #JAUSA-27720 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Failure Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3135172-2Report Type:Periodic Company Report #JAUSA-27721 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 4 MG 1 DAILY ORAL Ativan C Date:03/12/98ISR Number: 3135174-6Report Type:Periodic Company Report #JAUSA-27722 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3135175-8Report Type:Periodic Company Report #JAUSA-27723 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Consumer Risperdal Dysphagia (Risperidone), Syncope Janssen, Tablet PS Janssen ORAL 6 MG DAILY ORAL-4 MG DAILY ORAL Zoloft C Cogentin C 22-Feb-2006 08:20 AM Page: 114 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3135178-3Report Type:Periodic Company Report #JAUSA-27724 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematuria Consumer Risperdal (Risperidone), Janssen, Tablet PS Janssen ORAL 9 MG DAILY ORAL Klonopin C Date:03/12/98ISR Number: 3135179-5Report Type:Periodic Company Report #JAUSA-27725 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Consumer Risperdal Insomnia (Risperidone), Weight Increased Janssen, Tablet PS Janssen ORAL 6 MG 1 DAILY ORAL Lorazepam C Benadryl C Date:03/12/98ISR Number: 3135181-3Report Type:Periodic Company Report #JAUSA-27726 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gingival Hyperplasia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3135183-7Report Type:Periodic Company Report #JAUSA-27727 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal (Risperidone), Janssen, Tablet PS Janssen ORAL 3 MG 2 DAILY ORAL Klonopin C Sinequan C Date:03/12/98ISR Number: 3135185-0Report Type:Periodic Company Report #JAUSA-27728 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG DAILY ORAL-1.5 MG DAILY ORAL Date:03/12/98ISR Number: 3135187-4Report Type:Periodic Company Report #JAUSA-27730 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG DAILY 22-Feb-2006 08:20 AM Page: 115 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:03/12/98ISR Number: 3135189-8Report Type:Periodic Company Report #JAUSA-27738 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 7 MG 1 DAILY ORAL Date:03/12/98ISR Number: 3135191-6Report Type:Periodic Company Report #JAUSA-27739 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thirst Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3135194-1Report Type:Periodic Company Report #JAUSA-27741 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paralysis Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 4MG DAILY ORAL Date:03/12/98ISR Number: 3135197-7Report Type:Periodic Company Report #JAUSA-27742 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Risperdal Condition Aggravated (Risperidone), Janssen Tablet PS Janssen ORAL 4MG DAILY ORAL Tegretol C Lithium C Date:03/12/98ISR Number: 3135200-4Report Type:Periodic Company Report #JAUSA-27746 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone), Janssen Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3135201-6Report Type:Periodic Company Report #JAUSA-27750 Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocarditis Health Risperdal Professional (Risperidone) Janssen Tablet PS Janssen ORAL 1MG 2 DAILY ORAL 22-Feb-2006 08:20 AM Page: 116 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3135209-0Report Type:Periodic Company Report #JAUSA-27753 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Consumer Risperdal Oedema (Risperidone) Janssen Tablet PS Janssen ORAL ORAL Sinemet C Date:03/12/98ISR Number: 3135212-0Report Type:Periodic Company Report #JAUSA-27755 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Risperdal Initial or Prolonged Professional (Risperidone), Janssen, Tablets PS Janssen ORAL 2MG 2 DAILY ORAL, 3MG 2 DAILY ORAL Premarin (Estrogens Conjugated) SS 03MG DAILY Provera C Valproic Acid C Date:03/12/98ISR Number: 3135214-4Report Type:Periodic Company Report #JAUSA-27757 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Torticollis (Risperidone) Janssen Tablets PS Janssen ORAL 3MG 2 DAILY ORAL Date:03/12/98ISR Number: 3135217-XReport Type:Periodic Company Report #JAUSA-27758 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Osteoporosis Consumer Risperdal (Risperidone), Janssen, Img PS Janssen ORAL 1MG 2 DAILY ORAL Valium C Date:03/12/98ISR Number: 3135219-3Report Type:Periodic Company Report #JAUSA-27760 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Consumer Risperdal Erectile Dysfunction (Risperidone) Janssen Tablet PS Janssen ORAL 2.5MG DAILY ORAL Date:03/12/98ISR Number: 3135225-9Report Type:Periodic Company Report #JAUSA-27761 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accommodation Disorder Consumer Risperdal Vomiting (Risperidone), 22-Feb-2006 08:20 AM Page: 117 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Janssen Tablets PS Janssen ORAL 1MG SINGLE ORAL Date:03/12/98ISR Number: 3135228-4Report Type:Periodic Company Report #JAUSA-27773 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Consumer Risperdal Pain (Risperidone), Pain In Extremity Janssen Tablet 3mg PS Janssen ORAL 3MG DAILY ORAL Depakote C Date:03/12/98ISR Number: 3135230-2Report Type:Periodic Company Report #JAUSA-27780 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Pituitary Tumour Professional (Risperidone) Janssen Tablet PS Janssen ORAL 6MG DAILY ORAL Haldol (Haloperidol) Janssen Tablet SS Janssen ORAL 20MG DAILY ORAL Doxepin (Doxepin) SS ORAL 75MG DAILY ORAL, 150MG DAILY ORAL CAPSULES Date:03/12/98ISR Number: 3135233-8Report Type:Periodic Company Report #JAUSA-27790 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Risperdal Initial or Prolonged Pneumonia Professional (Risperidone), Janssen Tablet PS Janssen ORAL .5MG 2 DAILY ORAL Synthroid C Coumadin C Date:03/12/98ISR Number: 3135235-1Report Type:Periodic Company Report #JAUSA-27793 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Drug Level Below Professional (Risperidone), Therapeutic Janssen Tablet PS Janssen ORAL .5MG 2 DAILY Galactorrhoea ORAL Hyperprolactinaemia Paxil C Libido Decreased Depakote C Sedation Weight Increased 22-Feb-2006 08:20 AM Page: 118 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3135237-5Report Type:Periodic Company Report #JAUSA-27794 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Galactorrhoea Professional (Risperidone), Hyperprolactinaemia Janssen Tablet PS Janssen ORAL 3MG DAILY ORAL Luvox C Ambien C Date:03/12/98ISR Number: 3135240-5Report Type:Periodic Company Report #JAUSA-27796 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Professional (Risperidone) Janssen Tablet PS Janssen ORAL 6MG DAILY ORAL Date:03/12/98ISR Number: 3135242-9Report Type:Periodic Company Report #JAUSA-27802 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Professional (Risperidone) Janssen Tablet PS Janssen ORAL 2MG 2 DAILY ORAL Haldol-Decanoas C Depakote C Date:03/12/98ISR Number: 3135244-2Report Type:Periodic Company Report #JAUSA-27803 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Menstrual Disorder Professional (Risperidone) Nausea Janssen Tablet PS Janssen ORAL 4MG DAILY ORAL Klonopin C Date:03/12/98ISR Number: 3135247-8Report Type:Periodic Company Report #JAUSA-27804 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Leukopenia Professional (Risperidone) Janssen Tablet PS Janssen ORAL 3MG 2 DAILY ORAL Clozapine C Imipramine C Ativan C 22-Feb-2006 08:20 AM Page: 119 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3135248-XReport Type:Periodic Company Report #JAUSA-27806 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Vomiting Professional (Risperidone) Janssen Tablet PS Janssen ORAL 6MG DAILY ORAL Date:03/12/98ISR Number: 3135482-9Report Type:Periodic Company Report #JAUSA-25535 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal Deficit/Hyperactivity Professional (Risperidone) PS ORAL DAILY Disorder Date:03/12/98ISR Number: 3135485-4Report Type:Periodic Company Report #JAUSA-25544 Age:8 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone) PS ORAL 2 MG DAILY Date:03/12/98ISR Number: 3135488-XReport Type:Periodic Company Report #JAUSA-25547 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone) PS ORAL DAILY Date:03/12/98ISR Number: 3135490-8Report Type:Periodic Company Report #JAUSA-25634 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS ORAL 2 MG 2 DAILY Pituitary Tumour Benign Ativan (Lorazepam) C Visual Disturbance Wellbutrin (Amfebutamone) C Cogentin (Benztropine) C Vitamin A (Retional) C Zoloft (Sertraline) C Date:03/12/98ISR Number: 3135495-7Report Type:Periodic Company Report #JAUSA-25637 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Risperdal Initial or Prolonged Phosphokinase Increased Professional (Risperidone) PS ORAL DAILY Blood Lactate Prozac (Fluoxetine) C Dehydrogenase Increased Influenza Like Illness Respiratory Failure 22-Feb-2006 08:20 AM Page: 120 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3135498-2Report Type:Periodic Company Report #JAUSA-25681 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Photosensitivity Reaction Consumer Risperdal (Risperidone) PS ORAL DAILY Lithium (Lithium) C Clonopin (Clonazepam) C Tegratol (Carbamazepine) C Provera (Medroxyprogesterone ) C Date:03/12/98ISR Number: 3135502-1Report Type:Periodic Company Report #JAUSA-25739 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal Initial or Prolonged Professional (Risperidone) PS ORAL 1 MG 1 DAILY Propulsid (Cisapride) C Insulin, Nph (Insulin Interm. Act.) C Prilosec (Omeprazole) C Zoloft (Sertraline) C Aspirin (Acetylsalicylic-Aci d) C Colace (Docusate Sodium) C Metoprolol (Metoprolol) C Date:03/12/98ISR Number: 3135504-5Report Type:Periodic Company Report #JAUSA-25741 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthritis Consumer Risperdal Gait Disturbance (Risperidone) PS ORAL .5 MG 1 DAILY Hypertonia Atenolol (Atenolol) C Myalgia Lithium (Lithium) C Doxepin (Doxepin) C Date:03/12/98ISR Number: 3135506-9Report Type:Periodic Company Report #JAUSA-26153 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal Deficit/Hyperactivity Professional (Risperidone) PS ORAL DAILY Disorder Elavil (Amitriptyline) Tablet SS ORAL DAILY 22-Feb-2006 08:20 AM Page: 121 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3135713-5Report Type:Periodic Company Report #JAUSA-26930 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal PS Janssen ORAL Professional Haldol SS Janssen ORAL 7 MG DAILY Date:03/12/98ISR Number: 3135717-2Report Type:Periodic Company Report #JAUSA-26945 Age:94 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Risperdal PS ORAL DAILY Professional Trazodone C Date:03/12/98ISR Number: 3135721-4Report Type:Periodic Company Report #JAUSA-26722 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal PS Janssen ORAL TABLET, DAILY Amnesia ORAL Anorexia Nervousness Salivary Hypersecretion Weight Decreased Date:03/12/98ISR Number: 3135725-1Report Type:Periodic Company Report #JAUSA-26729 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hearing Impaired Health Risperdal PS Janssen ORAL TABLET, .5 MG Professional 2 DAILY ORAL Cogentin C Benadryl C Date:03/12/98ISR Number: 3135727-5Report Type:Periodic Company Report #JAUSA-26738 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Risperdal PS Janssen ORAL 2 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3135728-7Report Type:Periodic Company Report #JAUSA-26741 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Risperdal PS Janssen ORAL SEE IMAGE Professional Haldol C Buspar C Paxil C Retrovir C 22-Feb-2006 08:20 AM Page: 122 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3135733-0Report Type:Periodic Company Report #JAUSA-26762 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Study Risperdal PS Janssen ORAL 3 MG 2 DAILY Initial or Prolonged Diabetes Mellitus Health ORAL Hyperglycaemia Professional Nph C Hyponatraemia Insulin, Regular C Leukopenia Oedema Vomiting Date:03/12/98ISR Number: 3135738-XReport Type:Periodic Company Report #JAUSA-26766 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Retention Health Risperdal PS Janssen ORAL TABLET, DAILY Professional ORAL Date:03/12/98ISR Number: 3135740-8Report Type:Periodic Company Report #JAUSA-26770 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperparathyroidism Health Risperdal PS Janssen ORAL TABLET, DAILY Professional ORAL Date:03/12/98ISR Number: 3135743-3Report Type:Periodic Company Report #JAUSA-26772 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Risperdal PS Janssen ORAL TABLET, DAILY Professional ORAL Date:03/12/98ISR Number: 3135745-7Report Type:Periodic Company Report #JAUSA-26773 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal PS Janssen ORAL TABLET, 4 MG DAILY ORAL Date:03/12/98ISR Number: 3135748-2Report Type:Periodic Company Report #JAUSA-26782 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Consumer Risperdal PS Janssen ORAL TABLET, ORAL Initial or Prolonged Aphasia Insomnia Date:03/12/98ISR Number: 3135751-2Report Type:Periodic Company Report #JAUSA-26783 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Consumer Risperdal PS Janssen ORAL TABLET, DAILY ORAL 22-Feb-2006 08:20 AM Page: 123 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3135753-6Report Type:Periodic Company Report #JAUSA-26785 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Health Risperdal PS Janssen ORAL TABLET, DAILY Professional ORAL Date:03/12/98ISR Number: 3135755-XReport Type:Periodic Company Report #JAUSA-26786 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Risperdal PS Janssen ORAL TABLET, 1.5 Prolonged Professional MG DAILY ORAL Lithium C Depakote C Date:03/12/98ISR Number: 3135758-5Report Type:Periodic Company Report #JAUSA-26787 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS Janssen ORAL TABLET, 9 MG Galactorrhoea DAILY ORAL Hyperprolactinaemia Prozac C Weight Increased Diphenhydramine C Hormones Unsp. C Date:03/12/98ISR Number: 3135760-3Report Type:Periodic Company Report #JAUSA-26788 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal PS Janssen ORAL SEE IMAGE Hypoglycaemia Sedation Date:03/12/98ISR Number: 3135766-4Report Type:Periodic Company Report #JAUSA-26791 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Health Risperdal PS Janssen ORAL 1 MG DAILY Vomiting Professional ORAL Date:03/12/98ISR Number: 3135768-8Report Type:Periodic Company Report #JAUSA-26762 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, DAILY ORAL Anafranil C Depakote C Ativan C 22-Feb-2006 08:20 AM Page: 124 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3135773-1Report Type:Periodic Company Report #JAUSA-26793 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Health Risperdal PS Janssen ORAL TABLET, 5 MG Urinary Incontinence Professional DAILY ORAL AT BEDTIME Date:03/12/98ISR Number: 3135774-3Report Type:Periodic Company Report #JAUSA-26801 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Palpitations Health Risperdal PS Janssen ORAL TABLET, ORAL Professional Date:03/12/98ISR Number: 3135775-5Report Type:Periodic Company Report #JAUSA-26807 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal PS Janssen ORAL TABLET, ORAL Professional Prozac C Date:03/12/98ISR Number: 3135777-9Report Type:Periodic Company Report #JAUSA-29638 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Risperdal Initial or Prolonged Anxiety (Risperidone) PS Janssen ORAL TABLET, 7 MG Condition Aggravated DAILY ORAL Paraesthesia Synthroid C Sedation Tremor Weight Increased Date:03/12/98ISR Number: 3135778-0Report Type:Periodic Company Report #JAUSA-29639 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL TABLET, 1 MG 2 DAILY ORAL Prozac C Date:03/12/98ISR Number: 3135780-9Report Type:Periodic Company Report #JAUSA-29640 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal Professional (Risperidone) PS Janssen ORAL SEE IMAGE Date:03/12/98ISR Number: 3135782-2Report Type:Periodic Company Report #JAUSA-29641 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, 6 MG 22-Feb-2006 08:20 AM Page: 125 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAILY ORAL Date:03/12/98ISR Number: 3135784-6Report Type:Periodic Company Report #JAUSA-29642 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Initial or Prolonged Syndrome Professional (Risperidone) PS Janssen ORAL TABLET, ORAL Date:03/12/98ISR Number: 3135785-8Report Type:Periodic Company Report #JAUSA-29643 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, .5 MG 4 DAILY ORAL Date:03/12/98ISR Number: 3135787-1Report Type:Periodic Company Report #JAUSA-29644 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal Professional (Risperidone) PS Janssen ORAL SEE IMAGE Date:03/12/98ISR Number: 3135789-5Report Type:Periodic Company Report #JAUSA-29645 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Neuritis Professional (Risperidone) PS Janssen ORAL TABLET, 2 MG 2 DAILY ORAL Premarin C Date:03/12/98ISR Number: 3135791-3Report Type:Periodic Company Report #JAUSA-29646 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Pituitary Tumour Professional (Risperidone) PS Janssen ORAL SEE IMAGE 8 MON Date:03/12/98ISR Number: 3135793-7Report Type:Periodic Company Report #JAUSA-29647 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal Ejaculation Disorder (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Lithium C Date:03/12/98ISR Number: 3135795-0Report Type:Periodic Company Report #JAUSA-29649 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone) PS ORAL SEE IMAGE 22-Feb-2006 08:20 AM Page: 126 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lisinopril C Atenolol C Date:03/12/98ISR Number: 3135797-4Report Type:Periodic Company Report #JAUSA-29654 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Health Risperdal Osteoarthritis Professional (Risperidone) PS Janssen ORAL TABLET, 1 MG 3 DAILY ORAL Klonopin C Buspar C Prozac C Elavil C Ambien C Date:03/12/98ISR Number: 3135800-1Report Type:Periodic Company Report #JAUSA-29655 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Anorexia (Risperidone) PS Janssen ORAL 2 MG 1 DAILY Dystonia ORAL Salivary Hypersecretion Date:03/12/98ISR Number: 3135801-3Report Type:Periodic Company Report #JAUSA-29659 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Risperdal Syndrome Professional (Risperidone) PS Janssen ORAL TABLET, ORAL Date:03/12/98ISR Number: 3135802-5Report Type:Periodic Company Report #JAUSA-29662 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal Deficit/Hyperactivity Professional (Risperidone) PS Janssen ORAL TABLET, 1.5 Disorder MG 2 DAILY ORAL Date:03/12/98ISR Number: 3135803-7Report Type:Periodic Company Report #JAUSA-29665 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, .5 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3135805-0Report Type:Periodic Company Report #JAUSA-29666 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epistaxis Health Risperdal Professional (Risperidone) PS Janssen ORAL SEE IMAGE 22-Feb-2006 08:20 AM Page: 127 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C Date:03/12/98ISR Number: 3135807-4Report Type:Periodic Company Report #JAUSA-29668 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Consumer Risperdal (Risperidone) PS Janssen ORAL SEE IMAGE Zoloft C Xanax C Ambien C Date:03/12/98ISR Number: 3135809-8Report Type:Periodic Company Report #JAUSA-29669 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Neurosis Professional (Risperidone) PS Janssen ORAL TABLET, 3 MG 2 DAILY ORAL Paxil C Date:03/12/98ISR Number: 3135810-4Report Type:Periodic Company Report #JAUSA-29670 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Risperdal Oedema Professional (Risperidone) PS Janssen ORAL TABLET, ORAL Suicide Attempt Date:03/12/98ISR Number: 3135811-6Report Type:Periodic Company Report #JAUSA-29672 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hearing Impaired Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, ORAL Date:03/12/98ISR Number: 3135813-XReport Type:Periodic Company Report #JAUSA-29675 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Galactorrhoea Professional (Risperidone) PS Janssen ORAL 4 MG DAILY ORAL Date:03/12/98ISR Number: 3135816-5Report Type:Periodic Company Report #JAUSA-29676 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, ORAL 22-Feb-2006 08:20 AM Page: 128 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3137942-3Report Type:Periodic Company Report #JAUSA-26476 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal Professional (Risperidone) Janssen, Tablet PS Janssen ORAL ORAL (DOSES RANGE FORM 4-6 MG) Date:03/12/98ISR Number: 3137947-2Report Type:Periodic Company Report #JAUSA-26479 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Risperidal Constipation (Risperidone) Dysphagia Janssen Tablet PS Janssen ORAL .5 MG DAILY Gait Disturbance ORAL Salivary Hypersecretion Lanoxin C Urinary Incontinence Potassium C Lasix C Cardiazem C Sinemet C Date:03/12/98ISR Number: 3137949-6Report Type:Periodic Company Report #JAUSA-26480 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Risperdal Professional (Risperidone) Janssen, Tablet PS Janssen ORAL DAILY ORAL Date:03/12/98ISR Number: 3137951-4Report Type:Periodic Company Report #JAUSA-26485 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal Speech Disorder Professional (Risperidone) Janssen, Tablet PS Janssen ORAL 3 MG DAILY ORAL Date:03/12/98ISR Number: 3137952-6Report Type:Periodic Company Report #JAUSA-26495 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Speech Disorder Consumer Risperdal (Risperidone) Janssen, Tablet1 Mg PS Janssen ORAL 1 MG 2 DAILY ORAL Artane C Date:03/12/98ISR Number: 3137954-XReport Type:Periodic Company Report #JAUSA-26497 Age:50 YR Gender:Female I/FU:I Outcome PT Other Agitation Condition Aggravated 22-Feb-2006 08:20 AM Page: 129 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Contractions Involuntary Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal (Risperidone) Janssen, Tablet PS Janssen ORAL ORAL 5 MON Lithium C Date:03/12/98ISR Number: 3137956-3Report Type:Periodic Company Report #JAUSA-26499 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Study Risperdal Life-Threatening Health (Risperidone) Professional Janssen, Tablet PS Janssen ORAL DAILY ORAL Lithium C Trazodone C Depakote C Date:03/12/98ISR Number: 3137958-7Report Type:Periodic Company Report #JAUSA-26500 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Study Risperdal Initial or Prolonged Hyperglycaemia Health (Risperidone) Professional Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3137960-5Report Type:Periodic Company Report #JAUSA-26501 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Study Risperdal Initial or Prolonged Fall Health (Risperidone) Injury Professional Janssen, Tablet 2 Mg PS Janssen ORAL 4 MG DAILY Stupor ORAL Upper Respiratory Tract Ibuprofen C Infection Diazepam C Urinary Tract Infection Date:03/12/98ISR Number: 3137963-0Report Type:Periodic Company Report #JAUSA-26524 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Risperdal Dyspnoea Professional (Risperidone) Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY ORAL Anafranil C Trazodone C Clozapine C 22-Feb-2006 08:20 AM Page: 130 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3137965-4Report Type:Periodic Company Report #JAUSA-26527 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Consumer Risperdal (Risperidone) Janssen, Tablet PS Janssen ORAL 1 MG DAILY ORAL Date:03/12/98ISR Number: 3137967-8Report Type:Periodic Company Report #JAUSA-26528 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Menstrual Disorder Professional (Risperidone) Janssen, Tablet PS Janssen ORAL ORAL Eskalith C Klonopin C Synthroid C Date:03/12/98ISR Number: 3137968-XReport Type:Periodic Company Report #JAUSA-26529 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Consumer Risperdal Hypercholesterolaemia (Risperidone) Janssen, Tablet PS Janssen ORAL DAILY ORAL Zyprexa (Olanzapine) Tablet SS ORAL DAILY ORAL Date:03/12/98ISR Number: 3137969-1Report Type:Periodic Company Report #JAUSA-26546 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Professional (Risperidone) Janssen, Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3137975-7Report Type:Periodic Company Report #JAUSA-26547 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Risperdal Syndrome Professional (Risperidone) Janssen, Tablet PS Janssen ORAL DAILY ORAL Date:03/12/98ISR Number: 3137977-0Report Type:Periodic Company Report #JAUSA-26562 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Benign Health Risperdal Skin Striae Professional (Risperidone) Visual Disturbance Janssen, Tablet PS Janssen ORAL 6 MG DAILY Weight Increased ORAL-7.5 MG DAILY ORAL-9 MG DAILY ORAL (SEE IMAGE) 3 DAY 22-Feb-2006 08:20 AM Page: 131 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoloft C Stelazine C Prozac C Date:03/12/98ISR Number: 3137978-2Report Type:Periodic Company Report #JAUSA-26600 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Risperdal Initial or Prolonged Phosphokinase Increased Professional (Risperidone) Pneumonia Janssen, Tablet PS Janssen ORAL 2 MG DAILY ORAL Paxil C Date:03/12/98ISR Number: 3137979-4Report Type:Periodic Company Report #JAUSA-26601 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Risperdal Drug Abuser Professional (Risperidone) Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY ORAL Ridaura C Steroids C Date:03/12/98ISR Number: 3137980-0Report Type:Periodic Company Report #JAUSA-26602 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Risperdal (Risperidone) Janssen, Tablet PS Janssen ORAL ORAL Depakote (Valproate Sodium)Tablet SS ORAL ORAL Date:03/12/98ISR Number: 3138989-3Report Type:Periodic Company Report #JAUSA-26603 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Night Blindness Health Risperdal Professional (Risperidone) PS ORAL 3 MG 2 DAILY Trazodone (Trazodone) C Buspar (Buspirone) C Date:03/12/98ISR Number: 3138993-5Report Type:Periodic Company Report #JAUSA-26604 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Professional (Risperidone) PS ORAL DAILY 22-Feb-2006 08:20 AM Page: 132 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3138995-9Report Type:Periodic Company Report #JAUSA-26605 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Professional (Risperidone) PS ORAL DAILY Date:03/12/98ISR Number: 3138998-4Report Type:Periodic Company Report #JAUSA-26613 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Syncope Health Risperdal Professional (Risperidone) PS ORAL Digoxin (Digoxine) SS ORAL Verapamil (Verapamil) SS Date:03/12/98ISR Number: 3139000-0Report Type:Periodic Company Report #JAUSA-26614 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Hyponatraemia Professional (Risperidone) PS ORAL DAILY Respiratory Disorder Date:03/12/98ISR Number: 3139002-4Report Type:Periodic Company Report #JAUSA-26617 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal (Risperidone) PS ORAL Date:03/12/98ISR Number: 3139007-3Report Type:Periodic Company Report #JAUSA-26618 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Health Risperdal Extrapyramidal Disorder Professional (Risperidone) PS ORAL 1.5 MG DAILY Date:03/12/98ISR Number: 3139009-7Report Type:Periodic Company Report #JAUSA-26620 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Galactorrhoea (Risperidone) PS ORAL 4 MG DAILY 2 YR Hyperprolactinaemia Phenobarbital Tremor (Phenobarbital) C Urinary Incontinence Mellaril Weight Increased (Thioridazone) C Date:03/12/98ISR Number: 3139011-5Report Type:Periodic Company Report #JAUSA-26623 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Dyspnoea Initial or Prolonged Hypertonia 22-Feb-2006 08:20 AM Page: 133 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Sedation Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal (Risperidone) PS ORAL 2.5 MG DAILY Lanoxin (Digoxine) C Vasotec (Enalapril) C Date:03/12/98ISR Number: 3139014-0Report Type:Periodic Company Report #JAUSA-26628 Age:26 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paralysis Health Risperdal Sedation Professional (Risperidone) PS ORAL 6 MG DAILY 1 YR Date:03/12/98ISR Number: 3139017-6Report Type:Periodic Company Report #JAUSA-26631 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Consumer Risperdal Weight Increased (Risperidone) PS Janssen ORAL 1 MG 2 DAILY Trazodone (Trazodone) C Lorazepam (Lorazepam C Date:03/12/98ISR Number: 3139018-8Report Type:Periodic Company Report #JAUSA-26632 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal(Risperidon Hyperprolactinaemia Professional e) PS Janssen ORAL 2 MG DAILY Prozac (Fluoxetine) C Desyrel (Trazodone) C Klonopin (Clonazepam) C Contracept. Unsp (Oral Contracept. Unsp) C Date:03/12/98ISR Number: 3139022-XReport Type:Periodic Company Report #JAUSA-26634 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS ORAL 5 MG 3 DAILY Weight Increased Paxil (Paroxetine) C Date:03/12/98ISR Number: 3139024-3Report Type:Periodic Company Report #JAUSA-26653 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Distension Initial or Prolonged Amnesia Confusional State Dizziness Dysgeusia 22-Feb-2006 08:20 AM Page: 134 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Headache Hypoaesthesia Nightmare Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal (Risperidone) PS Janssen ORAL 2.5 MG DAILY Date:03/12/98ISR Number: 3139028-0Report Type:Periodic Company Report #JAUSA-26655 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Risperdal Prolonged Professional (Risperidone) PS Janssen ORAL 1 MG DAILY Nortriptyline (Nortiptyline) C Date:03/12/98ISR Number: 3139037-1Report Type:Periodic Company Report #JAUSA-26656 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Injection Site Health Risperdal Inflammation Professional (Risperidone) PS Janssen ORAL PRN Pain In Extremity Relafen (Nabumetone) C Date:03/12/98ISR Number: 3139042-5Report Type:Periodic Company Report #JAUSA-26657 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Coordination Abnormal Professional (Risperidone) PS Janssen ORAL 1.5 MG 4 Speech Disorder DAILY Urinary Tract Infection Glucotrol (Glipizide) C Aspirin (Acetylsalicylic-Aci d) C Urispas (Flavoxate) C Date:03/12/98ISR Number: 3139047-4Report Type:Periodic Company Report #JAUSA-26659 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Risperdal Initial or Prolonged Professional (Risperidone) PS Janssen ORAL 5 MG 1 DAILY Ativan (Lorazepam) C Zoloft (Sertraline) C Stelazine (Trifluoperazine) C Date:03/12/98ISR Number: 3139050-4Report Type:Periodic Company Report #JAUSA-26663 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Consumer Risperdal Hypertonia (Risperidone) PS Janssen ORAL 3 MG 2 DAILY Weight Increased Cogentin (Benztropine) C 22-Feb-2006 08:20 AM Page: 135 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139053-XReport Type:Periodic Company Report #JAUSA-26664 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Consumer Risperdal Eye Disorder (Risperidone) PS Janssen ORAL DAILY Torticollis Clozarinl (Clozapine) C Date:03/12/98ISR Number: 3139090-5Report Type:Periodic Company Report #JAUSA-29885 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Foetal Distress Syndrome Health Risperdal PS Janssen ORAL 6 MG DAILY Professional ORAL; 9 MG DAILY ORAL Date:03/12/98ISR Number: 3139094-2Report Type:Periodic Company Report #JAUSA-29899 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Risperdal PS ORAL 1 MG 1 DAILY Syncope Professional ORAL Prempro C Neurontin C Date:03/12/98ISR Number: 3139098-XReport Type:Periodic Company Report #JAUSA-29905 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal PS ORAL .5 MG 2 DAILY Initial or Prolonged Professional ORAL Ritalin C Date:03/12/98ISR Number: 3139102-9Report Type:Periodic Company Report #JAUSA-29908 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3139105-4Report Type:Periodic Company Report #JAUSA-29931 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Risperdal PS Janssen ORAL 12MG DAILY Hypertrichosis ORAL; Weight Increased INCREASED TO 16MG DAILY ORAL Risperdal SS ORAL 16 MG DAILY ORAL TABLET; DECREASED TO 12MG DAILY ORAL TABLET 22-Feb-2006 08:20 AM Page: 136 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139107-8Report Type:Periodic Company Report #JAUSA-29935 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3139109-1Report Type:Periodic Company Report #JAUSA-29938 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 3 MG 3 DAILY Extrapyramidal Disorder Professional ORAL/.25 MG DAILY ORAL Lithium C Date:03/12/98ISR Number: 3139111-XReport Type:Periodic Company Report #JAUSA-30967 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Consumer Risperidone PS Janssen ORAL 2 MG DAILY ORAL Hydrochlorothiazide C Date:03/12/98ISR Number: 3139112-1Report Type:Periodic Company Report #JAUSA-29939 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Libido Decreased Health Risperdal PS Janssen ORAL ORAL Tremor Professional Lithium C Date:03/12/98ISR Number: 3139113-3Report Type:Periodic Company Report #JAUSA-30970 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Consumer Risperidone PS Janssen ORAL 12 MG 1 DAILY Weight Increased ORAL Ativan C Melatonin C Prozac C Date:03/12/98ISR Number: 3139114-5Report Type:Periodic Company Report #JAUSA-29941 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombosis Health Risperdal PS Janssen ORAL .5MG 2 DAILY Initial or Prolonged Professional ORAL; 1 MG 2 DAILY ORAL TABLET Zoloft C 22-Feb-2006 08:20 AM Page: 137 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139115-7Report Type:Periodic Company Report #JAUSA-30972 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperidone PS Janssen ORAL .5 TO I. MG Professional DAILY ORAL Date:03/12/98ISR Number: 3139116-9Report Type:Periodic Company Report #JAUSA-29944 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Consumer Risperdal PS Janssen ORAL 3MG 2 DAILY ORAL; 1 MG 2 DAILY ORAL TABLET 1MG Lorazepam C Paxil C Date:03/12/98ISR Number: 3139117-0Report Type:Periodic Company Report #JAUSA-29946 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Risperdal PS Janssen ORAL 2MG 2 DAILY Professional ORAL Date:03/12/98ISR Number: 3139118-2Report Type:Periodic Company Report #JAUSA-30973 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperidone PS ORAL 1 MG 2 DAILY Galactorrhoea Professional ORAL Hyperprolactinaemia Date:03/12/98ISR Number: 3139119-4Report Type:Periodic Company Report #JAUSA-29948 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Risperdal PS Janssen ORAL 2 MG T DAILY Professional ORAL Date:03/12/98ISR Number: 3139120-0Report Type:Periodic Company Report #JAUSA-30976 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Health Risperidone PS Janssen ORAL 2 MG DAILY Hospitalization - Confusional State Professional ORAL Initial or Prolonged Pyrexia Paxil C Tremor Olanzapine C Sinemet C Ativan C Colace C Levothyroxine C Tegretol C Axid C Multivitamins C 22-Feb-2006 08:20 AM Page: 138 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139121-2Report Type:Periodic Company Report #JAUSA-29950 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Professional ORAL Date:03/12/98ISR Number: 3139122-4Report Type:Periodic Company Report #JAUSA-29953 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3139123-6Report Type:Periodic Company Report #JAUSA-29954 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Consumer Risperdal PS Janssen ORAL 3MG 2 DAILY Hyperacusis ORAL Hypoglycaemia Prolixin C Eskalith C Date:03/12/98ISR Number: 3139124-8Report Type:Periodic Company Report #JAUSA-29956 Age:97 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Consumer Risperdal PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3139125-XReport Type:Periodic Company Report #JAUSA-29962 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL 1.5 MG DAILY Professional ORAL Effexor C Date:03/12/98ISR Number: 3139127-3Report Type:Periodic Company Report #JAUSA-29963 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Risperdal PS Janssen ORAL 3MG 2 DAILY Initial or Prolonged Coma ORAL/3MG 1 Depression DAILY ORAL Drug Effect Increased TABLET 3MG/84 Muscular Weakness MG SINGLE Date:03/12/98ISR Number: 3139128-5Report Type:Periodic Company Report #JAUSA-29967 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Consumer Risperdal PS Janssen ORAL 1 MG 2 DAILY ORAL Provera C Cogentin C 22-Feb-2006 08:20 AM Page: 139 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139129-7Report Type:Periodic Company Report #JAUSA-29971 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Consumer Risperdal PS Janssen ORAL .5 MG 1 DAILY ORAL Mellaril C Ativan C Buspar C Date:03/12/98ISR Number: 3139130-3Report Type:Periodic Company Report #JAUSA-30983 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperidone PS Janssen ORAL -, ORAL Professional Date:03/12/98ISR Number: 3139131-5Report Type:Periodic Company Report #JAUSA-29972 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myalgia Consumer Risperdal PS Janssen ORAL .5MG 1 DAILY ORAL; ONLY 2 DOSES WERE TAKEN Xanax C Date:03/12/98ISR Number: 3139139-XReport Type:Periodic Company Report #JAUSA-30984 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Risperdal PS Janssen ORAL 1MG 1 DAILY Agitation ORAL Attention Doxepin C Deficit/Hyperactivity Disorder Libido Increased Date:03/12/98ISR Number: 3139141-8Report Type:Periodic Company Report #JAUSA-30986 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperidone PS Janssen ORAL -, ORAL Professional Eskalith C Artane C Bentyl C Amantadine C Date:03/12/98ISR Number: 3139145-5Report Type:Periodic Company Report #JAUSA-31022 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Risperidone PS Janssen ORAL 1 MG DAILY Hypothermia Professional ORAL Alendronate C Amitriptyline C Enalpril C 22-Feb-2006 08:20 AM Page: 140 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Furosemide C Zolpidem C Mvi C Potassium Chloride C Iron C Calcium C Date:03/12/98ISR Number: 3139147-9Report Type:Periodic Company Report #JAUSA-31026 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperidone PS ORAL 1 MG 1 DAILY ORAL Risperidone SS Paxil C Date:03/12/98ISR Number: 3139150-9Report Type:Periodic Company Report #JAUSA-31039 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Risperidone PS Janssen ORAL 1.5 MG DAILY ORAL Date:03/12/98ISR Number: 3139154-6Report Type:Periodic Company Report #JAUSA-31040 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Health Risperidone PS Janssen ORAL 3 MG 1 DAILY Professional ORAL Zoloft C Date:03/12/98ISR Number: 3139156-XReport Type:Periodic Company Report #JAUSA-31041 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Risperidone PS ORAL -, ORAL Date:03/12/98ISR Number: 3139160-1Report Type:Periodic Company Report #JAUSA-16623 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Risperidone PS Janssen ORAL 3 MG 2 DAILY Erectile Dysfunction ORAL Insomnia Risperidone SS 3 MG IN AM Sedation AND 3 MG AT BEDTIME Risperidone SS ORAL 6 MG DAILY ORAL 1 MG Lithium C ORAL 300 MG 3 DAILY ORAL 22-Feb-2006 08:20 AM Page: 141 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139163-7Report Type:Periodic Company Report #JAUSA-16859 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paraesthesia Literature Risperidone PS Janssen ORAL 1 MG 2 DAILY Health ORAL Professional Alprazolam C Propanolol C L-Thyroxine C Antacids C Date:03/12/98ISR Number: 3139167-4Report Type:Periodic Company Report #JAUSA-16860 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Pain Literature Risperidone PS Janssen ORAL 2 MG DAILY Paraesthesia Health ORAL Visual Disturbance Professional Risperidone SS ORAL 6 MG DAILY 2 MG 2 DAILY ORAL 11 WK Date:03/12/98ISR Number: 3139170-4Report Type:Periodic Company Report #JAUSA-16880 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperidone PS Janssen ORAL 2 MG 2 DAILY Hypertonia ORAL Increased Appetite Risperidone SS ORAL 1 MG 2 DAILY ORAL Risperidone SS ORAL 4 MG 1 DAILY ORAL Risperidone SS ORAL 6 MG 1 DAILY ORAL Date:03/12/98ISR Number: 3139172-8Report Type:Periodic Company Report #JAUSA-18554 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Photophobia Health Risperidone PS ORAL 12 MG DAILY Pituitary Tumour Benign Professional ORAL Visual Field Defect Risperidone SS 16MG Risperidone SS 16 MG DAILY ORAL Risperidone SS 12 MG DAILY ORAL Zoloft C Date:03/12/98ISR Number: 3139175-3Report Type:Periodic Company Report #JAUSA-18658 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Consumer Risperidone PS Janssen ORAL -,ORAL Initial or Prolonged Gait Disturbance Thorazine SS -,- Pituitary Tumour Thorazine SS Salivary Hypersecretion Haldol C Speech Disorder Lithium C Tongue Disorder Thyroid C Cogentin C 22-Feb-2006 08:20 AM Page: 142 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139181-9Report Type:Periodic Company Report #JAUSA-21801 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Health Risperidone PS ORAL 3 MG 1 DAILY Initial or Prolonged Confusional State Professional ORAL Risperidone SS 1 MG 1 DAILY ORAL Date:03/12/98ISR Number: 3139361-2Report Type:Periodic Company Report #JAUSA-26666 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Study Risperdal Initial or Prolonged Health (Risperidone),Jansse Professional n, Tablet 1 Mg PS Janssen ORAL 1 MG 2 DAILY ORAL Klonopin (Clonazepam) C Ativan (Lorazepam) C Date:03/12/98ISR Number: 3139363-6Report Type:Periodic Company Report #JAUSA-26685 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Risperdal Initial or Prolonged Professional (Risperidone),Jansse n, Tablet 1 Mg PS Janssen ORAL 3 MG 4 DAILY ORAL Ativan (Lorazepam) C Dilantin (Phenytoin) C Multivit C Date:03/12/98ISR Number: 3139364-8Report Type:Periodic Company Report #JAUSA-26686 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Risperdal Initial or Prolonged Ketoacidosis Professional (Risperidone),Jansse n, Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3139366-1Report Type:Periodic Company Report #JAUSA-26698(E) Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Galactorrhoea Professional (Risperidone),Jansse Hyperprolactinaemia n, Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3139369-7Report Type:Periodic Company Report #JAUSA-26699 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Dermatitis Professional (Risperidone),Jansse Extrapyramidal Disorder n, Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY Hyperprolactinaemia ORAL 22-Feb-2006 08:20 AM Page: 143 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin (Benztropine) C Hydrocortisone (Hydrocortisone) C Synthroid (Levothyroxine) C Date:03/12/98ISR Number: 3139370-3Report Type:Periodic Company Report #JAUSA-26700 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Consumer Risperdal (Risperidone),Jansse n, Tablet PS Janssen ORAL 6 MG DAILY ORAL Nortriptyline (Nortriptyline) C Klonopin (Clonazepam) C Cardiazem (Nitrendipine) C Ambien (Zolpidem) C Cogentin (Benztropine) C Date:03/12/98ISR Number: 3139372-7Report Type:Periodic Company Report #JAUSA-26702 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone),Jansse n, Tablet PS Janssen ORAL 3 MG DAILY ORAL Date:03/12/98ISR Number: 3139374-0Report Type:Periodic Company Report #JAUSA-26703 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Consumer Risperdal Hallucination (Risperidone),Jansse n, Tablet PS Janssen ORAL DAILY ORAL; PATIENT TAKES BETWEEN 8 MG TO 20 MG DAILY. Date:03/12/98ISR Number: 3139375-2Report Type:Periodic Company Report #JAUSA-26704 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cyanosis Health Risperdal Professional (Risperidone),Jansse n, Tablet 1 Mg PS ORAL 1.5 MG DAILY ORAL 22-Feb-2006 08:20 AM Page: 144 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139377-6Report Type:Periodic Company Report #JAUSA-26705 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal (Risperidone),Jansse n, Tablet PS Janssen ORAL 1.5 MG DAILY ORAL Artane (Trihexyphenidyl) C Date:03/12/98ISR Number: 3139378-8Report Type:Periodic Company Report #JAUSA-26706 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone),Jansse n, Tablet PS Janssen ORAL 1.5 MG 2 DAILY ORAL Depakote (Valproate Sodium) C Date:03/12/98ISR Number: 3139379-XReport Type:Periodic Company Report #JAUSA-26707 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal Professional (Risperidone),Jansse n, Tablet PS Janssen ORAL -, DAILY ORAL Zoloft (Sertraline) C Date:03/12/98ISR Number: 3139381-8Report Type:Periodic Company Report #JAUSA-26709 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Study Risperdal Initial or Prolonged Pain In Extremity Health (Risperidone),Jansse Professional n, Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY ORAL Stelazine (Triflyoperazine) C Maxzide (Maxzide(R)) C Altace (Ramipril) C Vicodin (Vicodin(R)) C Date:03/12/98ISR Number: 3139383-1Report Type:Periodic Company Report #JAUSA-26710 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG DAILY ORAL Lithium (Lithium) C Zantac (Ranitidine) C Diabeta (Glibenclamide) C 22-Feb-2006 08:20 AM Page: 145 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139384-3Report Type:Periodic Company Report #JAUSA-26711 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL 4 MG DAILY Pituitary Tumour Benign Professional ORAL Date:03/12/98ISR Number: 3139386-7Report Type:Periodic Company Report #JAUSA-26714 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal Attention (Risperidone),Jansse Deficit/Hyperactivity n, Tablet PS Janssen ORAL 9 MG DAILY Disorder ORAL Depression Insomnia Date:03/12/98ISR Number: 3139388-0Report Type:Periodic Company Report #JAUSA-26717 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epistaxis Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL -, DAILY ORAL Date:03/12/98ISR Number: 3139390-9Report Type:Periodic Company Report #JAUSA-26718 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Consumer Risperdal Vomiting (Risperidone),Jansse n, Tablet PS Janssen ORAL -, DAILY ORAL Date:03/12/98ISR Number: 3139392-2Report Type:Periodic Company Report #JAUSA-26720 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Injury (Risperidone),Jansse Tremor n, Tablet PS Janssen ORAL 2 MG DAILY ORAL Date:03/12/98ISR Number: 3139394-6Report Type:Periodic Company Report #JAUSA-26721 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Health Risperdal Photosensitivity Reaction Professional (Risperidone),Jansse n, Tablet 1 Mg PS Janssen ORAL 1 MG 2 DAILY ORAL; 3 MG 2 DAILY Thorazine (Chlorpromazine) C 22-Feb-2006 08:20 AM Page: 146 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139501-5Report Type:Periodic Company Report #JAUSA-30939 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Acute Health Risperidal PS Janseen ORAL ORAL Initial or Prolonged Professional Date:03/12/98ISR Number: 3139503-9Report Type:Periodic Company Report #JAUSA-30940 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Health Risperidal PS Janseen ORAL 2 MG 2 DAILY Drug Ineffective Professional ORAL Cogentin C Symmetrel C Date:03/12/98ISR Number: 3139506-4Report Type:Periodic Company Report #JAUSA-30941 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Health Risperidal PS Janseen ORAL 1.5 MG DAILY Gynaecomastia Professional ORAL/ 1 MG DAILY TAB Date:03/12/98ISR Number: 3139510-6Report Type:Periodic Company Report #JAUSA-30944 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Twitching Health Risperidal PS Janseen ORAL 8 MG DAILY Professional ORAL-DOSE WAS TITRATED DOWN UNTIL ITS DISCONTINUATI Clonazepam C Date:03/12/98ISR Number: 3139528-3Report Type:Periodic Company Report #JAUSA-30946 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperidal PS Janseen ORAL 1 MG 1 DAILY Hallucination ORAL TAKEN Nightmare AT HS ESTIMATED START DATE Zestoretic C Unspecified C Date:03/12/98ISR Number: 3139543-XReport Type:Periodic Company Report #JAUSA-30947 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Health Risperidal PS Janseen ORAL 1 MG 1 DAILY Professional ORAL TAKEN AT BEDTIME 22-Feb-2006 08:20 AM Page: 147 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139548-9Report Type:Periodic Company Report #JAUSA-30948 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Risperidal PS Janseen ORAL 3 MG ORAL- 1 Adrenal Insufficiency MG 2 DAILY Disorientation ORAL Repetitive Speech Date:03/12/98ISR Number: 3139552-0Report Type:Periodic Company Report #JAUSA-30950 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sluggishness Consumer Risperidal PS Janseen ORAL 3 MG 1 DAILY Vision Blurred ORAL Date:03/12/98ISR Number: 3139555-6Report Type:Periodic Company Report #JAUSA-30953 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Respiratory Depression Health Risperdal PS Janseen ORAL ORAL Professional Date:03/12/98ISR Number: 3139558-1Report Type:Periodic Company Report #JAUSA-30954 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Joint Stiffness Consumer Risperdal PS Janseen ORAL 2 MG 1 DAILY Muscular Weakness ORAL TAB Risperdal SS Jenseen ORAL 2 ML 1 DAILY ORAL SOL Haldol C Zyprexa C Tegretol C Date:03/12/98ISR Number: 3139561-1Report Type:Periodic Company Report #JAUSA-30955 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal PS Janseen ORAL 1 MG 1 DAILY Initial or Prolonged Haematocrit Decreased Professional ORAL Leukopenia Depakote C White Blood Cell Count Tegretol C Increased Akineton C Date:03/12/98ISR Number: 3139565-9Report Type:Periodic Company Report #JAUSA-30956 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Health Risperdal PS Janseen ORAL 1.5 MG DAILY Initial or Prolonged Dyskinesia Professional 0.5 MG ORAL Nausea IN AM, 1 MG Sedation IN PM Stupor Dexedrine C 22-Feb-2006 08:20 AM Page: 148 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139569-6Report Type:Periodic Company Report #JAUSA-30957 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Risperdal PS Janseen ORAL 3 MG DAILY Professional ORAL Depaktoe C Mevacor C Cogentin C Reglan C Date:03/12/98ISR Number: 3139573-8Report Type:Periodic Company Report #JAUSA-30958 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Risperdal PS Janseen ORAL ORAL Influenza Like Illness Professional Pyrexia Date:03/12/98ISR Number: 3139575-1Report Type:Periodic Company Report #JAUSA-30959 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Electrolytes Consumer Risperdal PS Janseen ORAL ORAL 3 MG 2 Increased DAILY 13 WK Dystonia Haldol C Tremor Erythromycin C Tetracycline C Zyprexa C Moban C Date:03/12/98ISR Number: 3139580-5Report Type:Periodic Company Report #JAUSA-30960 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janseen ORAL 4 MG DAILY Blood Prolactin Increased Professional ORAL- (1 MG Galactorrhoea IN AM; 3 MG IN PM) Date:03/12/98ISR Number: 3139584-2Report Type:Periodic Company Report #JAUSA-30961 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperidal PS Janseen ORAL ORAL Professional Date:03/12/98ISR Number: 3139587-8Report Type:Periodic Company Report #JAUSA-30962 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperidal PS Janseen ORAL 2 DAILY ORAL Blood Prolactin Increased Professional SEVERAL MONTHS 22-Feb-2006 08:20 AM Page: 149 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139590-8Report Type:Periodic Company Report #JAUSA-30963 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nasal Congestion Health Risperdal PS Janseen ORAL ORAL Reproductive Tract Professional Disorder Date:03/12/98ISR Number: 3139593-3Report Type:Periodic Company Report #JAUSA-30966 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Face Oedema Consumer Risperdal PS Janseen ORAL .5 MG 2 DAILY Galactorrhoea ORAL .5 MG IN Nasal Oedema THE AM, 0.5 Urinary Incontinence MG IN THE PM Provera C Estrogens Unspec C Slow Fe (Ferrous Sulfate) C Synthroid C Vancenase C Fosamax C Theragran-M C Os-Cal C Lithium C Klonopin C Mysoline C Levsinex C Date:03/12/98ISR Number: 3139647-1Report Type:Periodic Company Report #JAUSA-22560 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Study Risperdal PS ORAL 6 MG DAILY Hypercholesterolaemia Literature ORAL AT Hypertriglyceridaemia Health BEDTIME 7 MON Weight Increased Professional Risperdal (Risperidone) SS Guanfacine C Date:03/12/98ISR Number: 3139650-1Report Type:Periodic Company Report #JAUSA-22563 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Steatosis Study Risperdal PS Janssen ORAL 4 MG 2 DAILY Liver Function Test Literature ORAL 17 MON Abnormal Health Tetracycline C Weight Increased Professional Sertraline C Antipsychostic Unsp C Date:03/12/98ISR Number: 3139653-7Report Type:Periodic Company Report #JAUSA-22649 Age:43 YR Gender:Female I/FU:F Outcome PT Other Amenorrhoea Condition Aggravated Galactorrhoea 22-Feb-2006 08:20 AM Page: 150 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperprolactinaemia Pituitary Tumour Benign Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal PS Janssen ORAL 3 MG DAILY ORAL Risperdal SS ORAL 2 MG DAILY ORAL Risperdal SS ORAL 1.5 MG DAILY ORAL Risperdal SS ORAL 2.5 MG DAILY ORAL Depakote C Zoloft C Congentin C Bumex C Micro-K C Date:03/12/98ISR Number: 3139655-0Report Type:Periodic Company Report #JAUSA-23375 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Study Risperdal PS Janssen ORAL 2 MG 3 DAILY Initial or Prolonged Suicide Attempt Health ORAL Vomiting Professional Date:03/12/98ISR Number: 3139657-4Report Type:Periodic Company Report #JAUSA-23983 Age:48 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Foreign Risperal PS Janssen ORAL ORAL Life-Threatening Pulmonary Embolism Health Hospitalization - Professional Initial or Prolonged Date:03/12/98ISR Number: 3139659-8Report Type:Periodic Company Report #JAUSA-24090 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchospasm Health Risperda PS ORAL 3 MG 2 DAILY Initial or Prolonged Condition Aggravated Professional ORAL Conjunctivitis Risperdal SS ORAL 1 MG DAILY Convulsion ORAL Dyspnoea Atrovent C Oedema Proventil C Pneumonia Lanoxin C Rhinitis Ativan C Urinary Incontinence Artane C Urine Abnormality Benadryl C Date:03/12/98ISR Number: 3139661-6Report Type:Periodic Company Report #JAUSA-24349 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL ORAL Hyperprolactinaemia Professional 22-Feb-2006 08:20 AM Page: 151 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139663-XReport Type:Periodic Company Report #JAUSA-24796 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Riperdal PS ORAL 4 MG DAILY Phosphokinase Increased Professional ORAL Hypertension MAXIMUMM DOSE Risperdal SS Date:03/12/98ISR Number: 3139668-9Report Type:Periodic Company Report #JAUSA-24925 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Risperdal PS ORAL 2 MG ORAL Initial or Prolonged Gait Disturbance Hypokinesia Oculogyration Salivary Hypersecretion Speech Disorder Date:03/12/98ISR Number: 3139673-2Report Type:Periodic Company Report #JAUSA-25049 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Risperdal PS ORAL 3 MG 2 DAILY Leukopenia Professional ORAL Haldol C Dorzolamide C Timoptic C Tylenol C Ativan C Maalox C Date:03/12/98ISR Number: 3139676-8Report Type:Periodic Company Report #JAUSA-25085 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Folate Deficiency Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Initial or Prolonged Anaemia Vitamin B12 Professional ORAL Deficiency Dyspnoea Nausea Vomiting Date:03/12/98ISR Number: 3139679-3Report Type:Periodic Company Report #JAUSA-25271 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Health Risperdal PS Janssen ORAL 6 MG DAILY Life-Threatening Professional ORAL Thorazine SS Janssen ORAL DAILY ORAL Prolixin SS ORAL 20 MG DAILY ORAL Congentin C 22-Feb-2006 08:20 AM Page: 152 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139682-3Report Type:Periodic Company Report #JAUSA-25272 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Health Risperdal PS ORAL DAILY ORAL Hospitalization - Professional Initial or Prolonged Date:03/12/98ISR Number: 3139684-7Report Type:Periodic Company Report #JAUSA-25273 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Health Risperdal PS ORAL 6 MG DAILY Life-Threatening Professional ORAL Artane C Depakote C Klonopin C Effexor C Date:03/12/98ISR Number: 3139687-2Report Type:Periodic Company Report #JAUSA-25313 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Risperdal PS ORAL 2 MG DAILY Initial or Prolonged Thrombocytopenia Professional ORAL 1 WK Risperdal SS Date:03/12/98ISR Number: 3139689-6Report Type:Periodic Company Report #JAUSA-25314 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS ORAL 1 MG DAILY Hyperprolactinaemia Professional ORAL Risperdal (Risperidone) SS Date:03/12/98ISR Number: 3139692-6Report Type:Periodic Company Report #JAUSA-25398 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Health Risperdal PS ORAL DAILY ORAL Urinary Incontinence Professional Date:03/12/98ISR Number: 3139694-XReport Type:Periodic Company Report #JAUSA-25488 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Risperdal PS Janssen ORAL 6 MG DAILY Initial or Prolonged Dizziness Professional ORAL Dyspnoea Serzone SS ORAL 150 MG 2 Hypertension DAILY ORAL Hyperthermia Malignant Synthroid C Influenza Like Illness Malaise Tachycardia 22-Feb-2006 08:20 AM Page: 153 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139698-7Report Type:Periodic Company Report #JAUSA-25503 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal PS ORAL 5 MG DAILY Therapeutic Response Professional ORAL Unexpected Antiepileptic C Date:03/12/98ISR Number: 3139701-4Report Type:Periodic Company Report #JAUSA-25534 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Libido Decreased Health Risperdal PS ORAL 8 MG DAILY Professional ORAL Tegretol C Lithium C Date:03/12/98ISR Number: 3139709-9Report Type:Periodic Company Report #JAUSA-29790 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 2 MG 1 DAILY Drug Effect Decreased Professional ORAL Zoloft SS ORAL 100 MG 1 DAILY ORAL Inderal C Date:03/12/98ISR Number: 3139714-2Report Type:Periodic Company Report #JAUSA-29791 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3139717-8Report Type:Periodic Company Report #JAUSA-29793 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL _, ORAL, ON Professional DRUG TWO WEEKS 2 WK Date:03/12/98ISR Number: 3139722-1Report Type:Periodic Company Report #JAUSA-29794 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal PS Janssen ORAL 5 MG 2 DAILY Visual Disturbance ORAL Date:03/12/98ISR Number: 3139726-9Report Type:Periodic Company Report #JAUSA-29795 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal PS Janssen ORAL 2 MG 2 DAILY Professional ORAL Haldol SS Janssen 22-Feb-2006 08:20 AM Page: 154 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139730-0Report Type:Periodic Company Report #JAUSA-29798 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL _, ORAL Professional Date:03/12/98ISR Number: 3139732-4Report Type:Periodic Company Report #JAUSA-29800 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal PS Janssen ORAL _, ORAL Deficit/Hyperactivity Professional Disorder Date:03/12/98ISR Number: 3139735-XReport Type:Periodic Company Report #JAUSA-29801 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Professional ORAL Phenytoin C Valproic Acid C Cogentin C Depakene C Date:03/12/98ISR Number: 3139737-3Report Type:Periodic Company Report #JAUSA-29803 (') Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Libido Decreased Consumer Risperdal PS Janssen ORAL 5 MG 1 DAILY Weight Decreased ORAL Date:03/12/98ISR Number: 3139740-3Report Type:Periodic Company Report #JAUSA-29804 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal PS Janssen ORAL 3 MG DAILY ORAL Paxil C Date:03/12/98ISR Number: 3139742-7Report Type:Periodic Company Report #JAUSA-29805 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL _, ORAL Professional Date:03/12/98ISR Number: 3139764-6Report Type:Periodic Company Report #JAUSA-28930 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Albuminuria Health Risperdal Haematuria Professional (Risperidone), Polyuria Janssen, Tablet PS Janssen ORAL 8 MG DAILY Thirst ORAL 22-Feb-2006 08:20 AM Page: 155 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium (Lithium) Tablet SS ORAL -, ORAL,STOPPED DUE TO POLYURIA, POLYDIPSIA Depakote C Ritalin C Zoloft C Date:03/12/98ISR Number: 3139765-8Report Type:Periodic Company Report #JAUSA-28931 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Consumer Risperdal PS Janssen ORAL 3 MG 1 DAILY Menstrual Disorder ORAL Vomiting Date:03/12/98ISR Number: 3139766-XReport Type:Periodic Company Report #JAUSA-28932 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Malaise Consumer Risperdal (Risperidone) PS Janssen ORAL 1MG ORAL Aricept C Date:03/12/98ISR Number: 3139767-1Report Type:Periodic Company Report #JAUSA-28933 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Consumer Risperdal (Risperidone) PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3139768-3Report Type:Periodic Company Report #JAUSA-28934 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Risperdal Professional (Risperidone) PS Janssen ORAL 1MG 2 DAILY ORAL Tegretol (Carbamazepine) SS Date:03/12/98ISR Number: 3139769-5Report Type:Periodic Company Report #JAUSA-28938 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Weight Increased (Risperidone) PS Janssen ORAL 3MG 2 DAILY ORAL, 2MG 2 DAILY ORAL 22-Feb-2006 08:20 AM Page: 156 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139770-1Report Type:Periodic Company Report #JAUSA-28939 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Health Risperdal Professional (Risperidone) PS Janssen ORAL 8MG DAILY ORAL, 3MG 2 DAILY ORAL Lithium C Tegretol C Ativan C Date:03/12/98ISR Number: 3139771-3Report Type:Periodic Company Report #JAUSA-28940 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Health Risperdal Leukocytosis Professional (Risperidone) PS Janssen ORAL .25MG PM ORAL Neuroleptic Malignant Phenobarbital C Syndrome Vitamins C Folic Acid C Date:03/12/98ISR Number: 3139773-7Report Type:Periodic Company Report #JAUSA-29808 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Risperidal PS Janssen ORAL 3 MG DAILY Initial or Prolonged Condition Aggravated Professional ORAL Nausea Depakote SS Vomiting Weight Decreased Date:03/12/98ISR Number: 3139774-9Report Type:Periodic Company Report #JAUSA-29809 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Risperdal PS Janssen ORAL 2 MG DAILY Gait Disturbance Professional ORAL Oedema Peripheral Osteoarthritis Pain In Extremity Date:03/12/98ISR Number: 3139775-0Report Type:Periodic Company Report #JAUSA-29834 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 1 MG / 2 MG 1 Psychotic Disorder Professional DAILY ORAL SEE IMAGE 20 DAY Haldol C Ativan C Tegretol C Vistaril C Cogentin C 22-Feb-2006 08:20 AM Page: 157 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139776-2Report Type:Periodic Company Report #JAUSA-29859 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal PS Janssen ORAL _, ORAL Torticollis Professional Date:03/12/98ISR Number: 3139778-6Report Type:Periodic Company Report #JAUSA-29861 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Consumer Risperdal PS Janssen ORAL 2 MG 2 DAILY Convulsion ORAL Klonopin C Tenex C Date:03/12/98ISR Number: 3139780-4Report Type:Periodic Company Report #JAUSA-29877 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Risperdal PS Janssen ORAL 4 MG 1 DAILY Chest Pain Professional ORAL Electrocardiogram Asa C Abnormal Atenolol C Date:03/12/98ISR Number: 3139781-6Report Type:Periodic Company Report #JAUSA-29882 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Skin Discolouration Health Risperdal PS Janssen ORAL _, ORAL Professional Neurontin C Date:03/12/98ISR Number: 3139783-XReport Type:Periodic Company Report #JAUSA-29883 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL _, ORAL Professional Date:03/12/98ISR Number: 3139785-3Report Type:Periodic Company Report #JAUSA-29884 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS Janssen ORAL _, ORAL Date:03/12/98ISR Number: 3139786-5Report Type:Periodic Company Report #JAUSA-28942 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Muscle Contractions Professional (Risperidone) PS Janssen ORAL ORAL Involuntary 22-Feb-2006 08:20 AM Page: 158 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139787-7Report Type:Periodic Company Report #JAUSA-28948 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal PS Janssen ORAL 2MG 2 DAILY Condition Aggravated ORAL Dizziness Anafranil C Syncope Date:03/12/98ISR Number: 3139788-9Report Type:Periodic Company Report #JAUSA-28949 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Consumer Risperdal Priapism (Risperidone) PS Janssen ORAL 2MG 2 DAILY ORAL,3MG 2 DAILY ORAL Date:03/12/98ISR Number: 3139789-0Report Type:Periodic Company Report #JAUSA-28950 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Risperdal Dystonia Professional (Risperidone) PS Janssen ORAL 1MG 3 DAILY Salivary Hypersecretion ORAL Tremor Imipramine C Lithium C Melleril C Ritalin C Date:03/12/98ISR Number: 3139790-7Report Type:Periodic Company Report #JAUSA-28952 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Ritalin C Date:03/12/98ISR Number: 3139791-9Report Type:Periodic Company Report #JAUSA-28954 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Ritalin C Date:03/12/98ISR Number: 3139793-2Report Type:Periodic Company Report #JAUSA-28958 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal Deficit/Hyperactivity Professional (Risperidone) PS Janssen ORAL 2MG 1 DAILY Disorder ORAL,05MG 1 Depression DAILY ORAL 22-Feb-2006 08:20 AM Page: 159 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139801-9Report Type:Periodic Company Report #JAUSA-28959 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Risperdal Professional (Risperidone) PS Janssen ORAL 3MG 2 DAILY ORAL Cogentin C Doxepin C Date:03/12/98ISR Number: 3139804-4Report Type:Periodic Company Report #JAUSA-28960 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Paxil C Synthroid C Date:03/12/98ISR Number: 3139807-XReport Type:Periodic Company Report #JAUSA-28961 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal Deficit/Hyperactivity Professional (Risperidone) PS Janssen ORAL .5MG 2 DAILY Disorder ORAL, .5MG 3 Sedation DAILY ORAL Glucagon C Date:03/12/98ISR Number: 3139810-XReport Type:Periodic Company Report #JAUSA-28963 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 1.5MG 2 DAILY ORAL Date:03/12/98ISR Number: 3139813-5Report Type:Periodic Company Report #JAUSA-28964 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Consumer Risperdal Decreased (Risperidone) PS Janssen ORAL 3MG 2 DAILY ORAL Zoloft C Date:03/12/98ISR Number: 3139815-9Report Type:Periodic Company Report #JAUSA-28792 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Health Risperdal Professional (Risperidone), Janssen,Tablet PS ORAL ORAL Unspecified C 22-Feb-2006 08:20 AM Page: 160 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139819-6Report Type:Periodic Company Report #JAUSA-28794 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Anxiety (Risperidone), Insomnia Janssen, Tablet PS ORAL 4 MG DAILY Paranoia ORAL Wellbutrin C Buspar C Klonopin C Date:03/12/98ISR Number: 3139823-8Report Type:Periodic Company Report #JAUSA-28795 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Risperdal Professional (Risperidone) Janssen Tablet PS ORAL 5 MG DAILY ORAL Depakote C Date:03/12/98ISR Number: 3139825-1Report Type:Periodic Company Report #JAUSA-28796 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Consumer Risperdal Involuntary (Risperidone) Sedation Janssen Tablet PS ORAL 4 MG DAILY ORAL Trilafon C Pamelor C Benadryl C Date:03/12/98ISR Number: 3139828-7Report Type:Periodic Company Report #JAUSA-28797 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Health Risperdal Weight Decreased Professional (Risperidone), Janssen Tablet PS ORAL ORAL Date:03/12/98ISR Number: 3139831-7Report Type:Periodic Company Report #JAUSA-28799 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Risperdal Erectile Dysfunction (Risperidone), Visual Disturbance Janssen, Tablet 1 Mg PS ORAL 1 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3139833-0Report Type:Periodic Company Report #JAUSA-28801 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Health Risperdal Weight Decreased Professional (Risperidone) 22-Feb-2006 08:20 AM Page: 161 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Janssen Tablet PS ORAL ORAL Date:03/12/98ISR Number: 3139837-8Report Type:Periodic Company Report #JAUSA-28830 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Increased Health Risperdal Initial or Prolonged Electrocardiogram Qt Professional (Risperidone) Prolonged Janssen Tablet 12 Mg PS ORAL 4 MG DAILY Suicide Attempt ORAL Risperdal (Risperidone) SS ORAL 100 MG SINGLE ORAL TABLET 2 MG Lithium Carbonate C Ascorbic-Acid C Thiamine C Carafate C Folic Acid C Trazodone C Trazadone C Date:03/12/98ISR Number: 3139839-1Report Type:Periodic Company Report #JAUSA-28831 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone) Janssen Tablet 1 Mg PS ORAL 2 MG DAILY ORAL Date:03/12/98ISR Number: 3139841-XReport Type:Periodic Company Report #JAUSA-29753 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperdal (Risperidone) PS ORAL 3 MG DAILY Klonopin (Clonazepam) C Date:03/12/98ISR Number: 3139843-3Report Type:Periodic Company Report #JAUSA-28845 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Speech Disorder Consumer Risperdal Thinking Abnormal (Risperidone) Janssen Tablet PS ORAL ORAL Specified C Date:03/12/98ISR Number: 3139845-7Report Type:Periodic Company Report #JAUSA-28854 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperdone) ,Janssen Tablet PS ORAL 1 MG 2 DAILY ORAL 22-Feb-2006 08:20 AM Page: 162 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139846-9Report Type:Periodic Company Report #JAUSA-29754 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Urea Increased Health Risperdal Pruritus Professional (Risperidone) PS ORAL 2 MG DAILY Rash Erythematous Benztropine (Benztropine) SS ORAL Depakote (Valproate Sodium) C Ativan (Lorazepam) C Date:03/12/98ISR Number: 3139847-0Report Type:Periodic Company Report #JAUSA-28856 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Health Risperdal Professional (Risperidone) Janssen Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3139848-2Report Type:Periodic Company Report #JAUSA-29755 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Health Risperdal Professional (Risperidone) PS ORAL 1 MG DAILY Luvox (Fluvoxamine) C Prozac (Fluoxetine) C Imipramine (Imipramine) C Date:03/12/98ISR Number: 3139849-4Report Type:Periodic Company Report #JAUSA-29756 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Risperdal Salivary Hypersecretion Professional (Risperidone) PS ORAL 12 MG DAILY Speech Disorder Eskalith (Lithium) C Date:03/12/98ISR Number: 3139850-0Report Type:Periodic Company Report #JAUSA-29757 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone) PS ORAL 9 MG DAILY Haldol (Haloperidol) C Trilafon (Perphenazine) C Stelazine (Trifluoperazine) C Date:03/12/98ISR Number: 3139851-2Report Type:Periodic Company Report #JAUSA-29758 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Skin Striae Health Risperdal Weight Increased Professional (Risperidone) PS ORAL 2 MG DAILY 22-Feb-2006 08:20 AM Page: 163 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Wellbutrin (Amfebutamone) C Date:03/12/98ISR Number: 3139852-4Report Type:Periodic Company Report #JAUSA-29759 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Skin Striae Health Risperdal Professional (Risperidone) PS ORAL Date:03/12/98ISR Number: 3139853-6Report Type:Periodic Company Report #JAUSA-29760 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal Professional (Risperidone) PS ORAL 3 MG 1 DAILY Date:03/12/98ISR Number: 3139854-8Report Type:Periodic Company Report #JAUSA-28857 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Increased Health Risperdal Initial or Prolonged Suicide Attempt Professional (Risperidone) Janssen Tablet PS Janssen ORAL 2 MG 2 DAILY ORAL Effexor C Date:03/12/98ISR Number: 3139855-XReport Type:Periodic Company Report #JAUSA-29762 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS ORAL 2 MG 1 DAILY Pituitary Tumour Date:03/12/98ISR Number: 3139857-3Report Type:Periodic Company Report #JAUSA-29763 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Risperidal Prolonged Professional (Risperidone) PS ORAL .5MG 2 DAILY 2 WK Klonopin (Clonazepam) C Prozac (Fluoxetine) C Date:03/12/98ISR Number: 3139859-7Report Type:Periodic Company Report #JAUSA-29764 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone) PS ORAL 2 MG 1 DAILY Prozac (Fluoxetine) C 22-Feb-2006 08:20 AM Page: 164 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139861-5Report Type:Periodic Company Report #JAUSA-29765 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Health Risperdal Professional (Risperidone) PS ORAL 6 MG DAILY Depakote C Trazodine (Trazodone) C Date:03/12/98ISR Number: 3139863-9Report Type:Periodic Company Report #JAUSA-29766 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscular Weakness Health Risperdal Initial or Prolonged Neuroleptic Malignant Professional (Risperidone) PS ORAL 1 MG 2 DAILY Syndrome Prolixin (Fluphenzine) C Cogentin (Benztropine) C Date:03/12/98ISR Number: 3139865-2Report Type:Periodic Company Report #JAUSA-29768 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal Deficit/Hyperactivity Professional (Risperidone) PS ORAL Disorder Date:03/12/98ISR Number: 3139867-6Report Type:Periodic Company Report #JAUSA-29779 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal (Risperidone) PS ORAL 1 MG 1 DAILY Date:03/12/98ISR Number: 3139869-XReport Type:Periodic Company Report #JAUSA-29780 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Risperdal Abnormal Professional (Risperidone) PS ORAL .5MG 2 DAILY Thorazine (Chlorpromazine) Tablet SS ORAL 50 MG Depakote C Date:03/12/98ISR Number: 3139871-8Report Type:Periodic Company Report #JAUSA-29781 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cystitis Consumer Risperdal Drug Withdrawal Syndrome (Risperidone) PS ORAL 1 MG 2 DAILY Lorazepam (Lorazepam) C 22-Feb-2006 08:20 AM Page: 165 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139874-3Report Type:Periodic Company Report #JAUSA-29782 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone) PS ORAL Date:03/12/98ISR Number: 3139877-9Report Type:Periodic Company Report #JAUSA-29787 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Consumer Risperdal Insomnia (Risperidone) PS ORAL 2 MG 1 DAILY Sedation Dilantin (Phenytoin) C Lanoxin (Digoxine) C Date:03/12/98ISR Number: 3139881-0Report Type:Periodic Company Report #JAUSA-29788 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Health Risperdal Headache Professional (Risperidone) PS ORAL 1 MG 2 DAILY Hypertension Paxil (Paroxetine) C Oculogyration Thorazine Speech Disorder (Chlorpromazine) C Moban (Molindone) C Cogentin (Benztropine) C Date:03/12/98ISR Number: 3139926-8Report Type:Periodic Company Report #JAUSA-28904 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Risperdal Phosphokinase Increased Professional (Risperidone) Janssen Tablet PS Janssen ORAL 4 MG DAILY ORAL Risperdal (Risperidone) SS ORAL 6 MG DAILY ORAL Date:03/12/98ISR Number: 3139931-1Report Type:Periodic Company Report #JAUSA-28919 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Abnormal Health Risperdal Professional (Risperidone) Janssen Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3139934-7Report Type:Periodic Company Report #JAUSA-28921 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Risperdal Dizziness (Risperidone) PS Janssen ORAL 2MG 2 DAILY Nausea ORAL Sedation 22-Feb-2006 08:20 AM Page: 166 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139937-2Report Type:Periodic Company Report #JAUSA-28923 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone) PS Janssen ORAL 1MG 1 DAILY ORAL Date:03/12/98ISR Number: 3139940-2Report Type:Periodic Company Report #JAUSA-28924 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal Attention (Risperidone) PS Janssen ORAL ORAL Deficit/Hyperactivity Prolixin Disorder (Fluphenazine) SS Date:03/12/98ISR Number: 3139943-8Report Type:Periodic Company Report #JAUSA-28925 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hypertrophy Breast Professional (Risperidone) PS Janssen ORAL 2MG 2 DAILY ORAL,3MG 2 DAY ORAL 14 DAY Date:03/12/98ISR Number: 3139948-7Report Type:Periodic Company Report #JAUSA-28926 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Health Risperdal Professional (Risperidone) PS Janssen ORAL 4MG DAILY ORAL Multivitamins C Diphenhydramine C Date:03/12/98ISR Number: 3139950-5Report Type:Periodic Company Report #JAUSA-28967 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Consumer Risperdal Decreased (Risperidone), Janssen, Tablet PS Janssen ORAL /6 MG 1 DAILY ORAL/3MG IN AM 3 MG AT PM Prolixin C Date:03/12/98ISR Number: 3139957-8Report Type:Periodic Company Report #JAUSA-28968 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Risperdal Professional (Risperidone), Janssen, Tablet 3mg PS Janssen ORAL 3 MG 2 DAILY ORAL/2 MG 2 DAILY ORAL Olanzapine SS 50MG 1 DAILY 22-Feb-2006 08:20 AM Page: 167 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report - TAKEN AT BEDTIME Benztropine C Date:03/12/98ISR Number: 3139960-8Report Type:Periodic Company Report #JAUSA-28969 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cough Consumer Risperdal Dizziness (Risperidone), Insomnia Janssen, Tablet PS Janssen ORAL 4 MG 1 DAILY Nausea ORAL Palpitations Zyprexa C Rhinitis Thinking Abnormal Date:03/12/98ISR Number: 3139961-XReport Type:Periodic Company Report #JAUSA-28972 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Weight Increased Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 4 MG DAILY ORAL Neurontin C Date:03/12/98ISR Number: 3139962-1Report Type:Periodic Company Report #JAUSA-28973 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Health Risperdal Initial or Prolonged Therapeutic Response Professional (Risperidone), Increased Janssen, Tablet PS Janssen ORAL -, ORAL Cardizem C Lotensin C Date:03/12/98ISR Number: 3139963-3Report Type:Periodic Company Report #JAUSA-28974 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL -, ORAL Date:03/12/98ISR Number: 3139964-5Report Type:Periodic Company Report #JAUSA-28975 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL -, ORAL 22-Feb-2006 08:20 AM Page: 168 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3139965-7Report Type:Periodic Company Report #JAUSA-28978 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Pain Health Risperdal Gynaecomastia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 5 MG DAILY ORAL Tegretol (Carbamazepine) SS ORAL 900 MG DAIL ORAL Paxil C Date:03/12/98ISR Number: 3139966-9Report Type:Periodic Company Report #JAUSA-28979 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL -, ORAL Date:03/12/98ISR Number: 3139967-0Report Type:Periodic Company Report #JAUSA-28981 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Risperdal Professional (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY ORAL Cogentin C Date:03/12/98ISR Number: 3139968-2Report Type:Periodic Company Report #JAUSA-28982 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Health Risperdal Dystonia Professional (Risperidone), Janssen, Tablets PS Janssen ORAL 2 MG 2 DAILY ORAL/PRN ORAL Aricept (Donepezil) SS ORAL -, ORAL Cognex C Date:03/12/98ISR Number: 3139969-4Report Type:Periodic Company Report #JAUSA-28983 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL -, ORAL Date:03/12/98ISR Number: 3139971-2Report Type:Periodic Company Report #JAUSA-28985 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Risperdal Professional (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG 3 DAILY 22-Feb-2006 08:20 AM Page: 169 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Restoril (Temazepam) Capsules SS ORAL -, DAILY ORAL Cogentin C Klonopin C Date:03/12/98ISR Number: 3139973-6Report Type:Periodic Company Report #JAUSA-28988 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL -, ORAL Date:03/12/98ISR Number: 3139975-XReport Type:Periodic Company Report #JAUSA-28989 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Libido Decreased Consumer Risperdal Weight Increased (Risperidone), Janssen, Tablet PS Janssen ORAL -, ORAL Estrogens C Date:03/12/98ISR Number: 3139977-3Report Type:Periodic Company Report #JAUSA-28990 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Weight Increased Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG 1 DAILY ORAL Depakote C Date:03/12/98ISR Number: 3139979-7Report Type:Periodic Company Report #JAUSA-29029 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Consumer Risperdal (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL 4.5 MG DAILY ORAL Date:03/12/98ISR Number: 3139981-5Report Type:Periodic Company Report #JAUSA-29032 Age:52 YR Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Alopecia Anxiety Arrhythmia Attention Deficit/Hyperactivity Disorder Chest Pain Constipation Coordination Abnormal Dry Mouth 22-Feb-2006 08:20 AM Page: 170 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyspnoea Dystonia Fatigue Report Source Product Role Manufacturer Route Dose Duration Gait Disturbance Consumer Risperdal Galactorrhoea (Risperidone), Hyperhidrosis Janssen, Tablet PS Janssen ORAL 6 MG DAILY Insomnia ORAL Neuropathy Peripheral Synthroid C Pain Promethazine C Pain In Extremity Cogentin C Pallor Paraesthesia Purpura Rhinitis Speech Disorder Suicide Attempt Syncope Tachycardia Thirst Tongue Discolouration Urinary Incontinence Visual Disturbance Date:03/12/98ISR Number: 3139985-2Report Type:Periodic Company Report #JAUSA-29034 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Consumer Risperdal Speech Disorder (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG 2 DAILY ORAL Lithium C Date:03/12/98ISR Number: 3139988-8Report Type:Periodic Company Report #JAUSA-29035 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysuria Health Risperdal Pollakiuria Professional (Risperidone), Janssen, Tablet PS Janssen ORAL -, ORAL Date:03/12/98ISR Number: 3140104-7Report Type:Periodic Company Report #JAUSA-28734 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS Janssen ORAL SEE IMAGE Diarrhoea Ativan C Vomiting Cogentin C Date:03/12/98ISR Number: 3140106-0Report Type:Periodic Company Report #JAUSA-28738 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL SEE IMAGE Hyperprolactinaemia Professional Antibiot. Unspec C Zoloft C 22-Feb-2006 08:20 AM Page: 171 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3140108-4Report Type:Periodic Company Report #JAUSA-28741 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal PS Janssen ORAL TABLET, ORAL Urinary Incontinence Professional Date:03/12/98ISR Number: 3140110-2Report Type:Periodic Company Report #JAUSA-28743 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal PS Janssen ORAL TABLET, DAILY Tinnitus ORAL Lithium C Date:03/12/98ISR Number: 3140112-6Report Type:Periodic Company Report #JAUSA-28746 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal PS Janssen ORAL TABLET, 1.5 Deficit/Hyperactivity Professional MG 2 DAILY Disorder ORAL Zoloft C Date:03/12/98ISR Number: 3140114-XReport Type:Periodic Company Report #JAUSA-28749 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal PS Janssen ORAL SEE IMAGE Hallucination Couadin C Thrombosis Zestril C Lasix C Potassium C Date:03/12/98ISR Number: 3140115-1Report Type:Periodic Company Report #JAUSA-28753 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Consumer Risperdal PS Janssen ORAL 2 MG 2 DAILY Speech Disorder ORAL Insulin, Nph C Trazodone C Klonopin C Isordil C Digoxin C Lasix C Coumadin C Vitamin E C Date:03/12/98ISR Number: 3140117-5Report Type:Periodic Company Report #JAUSA-28761 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL TABLET, ORAL Professional Unspecified C 22-Feb-2006 08:20 AM Page: 172 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3140123-0Report Type:Periodic Company Report #JAUSA-28766 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Consumer Risperdal PS Janssen ORAL TABLET, ORAL Date:03/12/98ISR Number: 3140252-1Report Type:Periodic Company Report #JAUSA-28767 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY ORAL Depakote SS Date:03/12/98ISR Number: 3140253-3Report Type:Periodic Company Report #JAUSA-28769 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal PS Janssen ORAL 1 MG 1 DAILY ORAL Prozac SS Date:03/12/98ISR Number: 3140254-5Report Type:Periodic Company Report #JAUSA-28778 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urea Increased Health Risperdal PS Janssen ORAL TABLET, 5 Initial or Prolonged Convulsion Professional DAILY ORAL 5 DAY Drug Abuser Date:03/12/98ISR Number: 3140255-7Report Type:Periodic Company Report #JAUSA-28779 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Risperdal PS Janssen ORAL TABLET, ORAL Initial or Prolonged Blood Creatine Professional Haldol SS Janssen ORAL ORAL Phosphokinase Increased Cogentin C Confusional State Hypokalaemia Date:03/12/98ISR Number: 3140256-9Report Type:Periodic Company Report #JAUSA-28782 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal PS Janssen ORAL TABLET, ORAL 5 MON Delusion Date:03/12/98ISR Number: 3140257-0Report Type:Periodic Company Report #JAUSA-28784 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epistaxis Consumer Risperdal PS Janssen ORAL TABLET, ORAL Syncope 22-Feb-2006 08:20 AM Page: 173 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3140258-2Report Type:Periodic Company Report #JAUSA-28785 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal PS Janssen ORAL TABLET, ORAL Professional Unspecified C Date:03/12/98ISR Number: 3140259-4Report Type:Periodic Company Report #JAUSA-28786 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Risperdal PS Janssen ORAL SEE IMAGE Tachycardia Professional Date:03/12/98ISR Number: 3140260-0Report Type:Periodic Company Report #JAUSA-28787 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL TABLET, 5 MG Professional ORAL Hormones C Nefazodone C Date:03/12/98ISR Number: 3140261-2Report Type:Periodic Company Report #JAUSA-28788 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 4 MG 2 DAILY Porphyria Non-Acute Professional ORAL Date:03/12/98ISR Number: 3140262-4Report Type:Periodic Company Report #JAUSA-28791 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS Janssen ORAL SEE IMAGE Hepatic Function Abnormal Hyperprolactinaemia Weight Increased Date:03/12/98ISR Number: 3140315-0Report Type:Periodic Company Report #JAUSA-27256 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal PS Janssen ORAL 3 MG DAILY ORAL Date:03/12/98ISR Number: 3140317-4Report Type:Periodic Company Report #JAUSA-27258 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal PS Janssen ORAL 6 MG DAILY Professional ORAL 2MG IN AM; 4MG IN PM. Propulsid SS Janssen ORAL DAILY ORAL 22-Feb-2006 08:20 AM Page: 174 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3140319-8Report Type:Periodic Company Report #JAUSA-27260 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Consumer Risperdal PS Janssen ORAL DAILY, ORAL Headache Date:03/12/98ISR Number: 3140320-4Report Type:Periodic Company Report #JAUSA-27262 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Consumer Risperdal PS Janssen ORAL 3 MG DAILY ORAL Chloral-Hydrate C Trazodone C Date:03/12/98ISR Number: 3140324-1Report Type:Periodic Company Report #JAUSA-27263 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Risperdal PS Janssen ORAL ORAL Phosphokinase Increased Professional Blood Lactate Dehydrogenase Increased Date:03/12/98ISR Number: 3140327-7Report Type:Periodic Company Report #JAUSA-27264 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Consumer Risperdal PS Janssen ORAL ORAL Eye Disorder Benadryl C Respiratory Disorder Cogentin C Date:03/12/98ISR Number: 3140329-0Report Type:Periodic Company Report #JAUSA-27265 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Risperdal PS Janssen ORAL 1 MG 1 DAILY Professional ORAL 1.25 MG 1 DAILY 5 WK Date:03/12/98ISR Number: 3140331-9Report Type:Periodic Company Report #JAUSA-27267 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Weight Decreased Professional ORAL Date:03/12/98ISR Number: 3140334-4Report Type:Periodic Company Report #JAUSA-27269 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Consumer Risperdal PS Janssen ORAL 1 MG 2 DAILY ORAL Mellaril C 22-Feb-2006 08:20 AM Page: 175 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3140336-8Report Type:Periodic Company Report #JAUSA-27270 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL 6 MG DAILY Professional ORAL 3 MG Anafranil C Tegretol C Date:03/12/98ISR Number: 3140339-3Report Type:Periodic Company Report #JAUSA-27271 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL 6 MG DAILY Hyperprolactinaemia Professional ORAL 4 MG 19 DAY Date:03/12/98ISR Number: 3140342-3Report Type:Periodic Company Report #JAUSA-29036 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Risperdal PS Janssen ORAL 7.5 MG DAILY Initial or Prolonged Neuroleptic Malignant Professional ORAL Syndrome Date:03/12/98ISR Number: 3140343-5Report Type:Periodic Company Report #JAUSA-29037 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Risperdal PS Janssen ORAL 4 MG 2 DAILY Initial or Prolonged Phosphokinase Increased Professional ORAL 3 DAY Hyperpyrexia Clozapine Hypertension (Clozapine) C Hypertonia Robinul Leukocytosis (Glycopyrronium) C Syncope Tachycardia Date:03/12/98ISR Number: 3140346-0Report Type:Periodic Company Report #JAUSA-29038 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Consumer Risperdal PS Janssen ORAL 3 MG DAILY Initial or Prolonged Cough ORAL Dizziness Depakote (Valproate Dysphagia Sodium) C Gamma-Glutamyltransferase Eye Drops, Unsp (Eye Increased Drops, Unsp) C Hyponatraemia Myalgia Productive Cough Sedation Thirst Urinary Tract Infection 22-Feb-2006 08:20 AM Page: 176 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3140349-6Report Type:Periodic Company Report #JAUSA-29055 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal PS Janssen ORAL 6 MG DAILY Decreased Professional ORAL; 8 MG DAILY Date:03/12/98ISR Number: 3140353-8Report Type:Periodic Company Report #JAUSA-29058 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal PS Janssen ORAL ORAL Initial or Prolonged Syndrome Professional Pneumonia Rhabdomyolysis Date:03/12/98ISR Number: 3140356-3Report Type:Periodic Company Report #JAUSA-29078 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal PS Janssen ORAL 1.5 MG 2 Professional DAILY ORAL (DOSE TITRATED DOWN TO Depakote (Valproate Sodium) C Buspar (Buspirone) C Date:03/12/98ISR Number: 3140359-9Report Type:Periodic Company Report #JAUSA-29079 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Risperdal PS Janssen ORAL .5 MG PM ORAL Professional Dexedrine (Dexamphetamine) C Ventolin (Salbutamol) C Date:03/12/98ISR Number: 3140365-4Report Type:Periodic Company Report #JAUSA-29083 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Disorder Consumer Risperdal PS Janssen ORAL 3 MG 1 DAILY Epiphysiolysis ORAL Pepcid (Famotidine) C Date:03/12/98ISR Number: 3140368-XReport Type:Periodic Company Report #JAUSA-29084 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Risperdal PS Janssen ORAL DAILY ORAL Attention Professional (DOSE VARIED Deficit/Hyperactivity DAILY) Disorder Depakote (Valproate Sodium) C 22-Feb-2006 08:20 AM Page: 177 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neutrontin (Gabapentin) C Felbatol (Felbamate) C Date:03/12/98ISR Number: 3140369-1Report Type:Periodic Company Report #JAUSA-29085 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Risperdal PS Janssen ORAL 1) 1 MG DAILY Libido Decreased ORAL (DOSE Sedation VARIED Speech Disorder BETWEEN 0.5 Tongue Disorder AND 1 MG Tremor Lithonate (Lithium) C Tegretol (Carbamazepine) C Date:03/12/98ISR Number: 3140373-3Report Type:Periodic Company Report #JAUSA-29087 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Health Risperdal PS Janssen ORAL 3 MG DAILY Professional ORAL (COMMENTS: TITRATED UP OVER THREE Date:03/12/98ISR Number: 3140376-9Report Type:Periodic Company Report #JAUSA-29089 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal PS Janssen ORAL 20 MG DAILY Professional ORAL Tegretol (Carbamazepine) C Zoloft (Sertraline) C Hypoglycemics (Hypoglycemics) C Pepcid (Famotidine) C Date:03/12/98ISR Number: 3140379-4Report Type:Periodic Company Report #JAUSA-29090 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Consumer Risperdal PS Janssen ORAL 3 MG DAILY Tardive Dyskinesia ORAL MON Chloral-Hydrate (Chloral-Hydrate) SS (COMMENTS: STARTED AFTER DISCONTINUING RISPERDAL) Phenobarbital (Phenobarbital) SS Thorazine (Chlorpromazine) SS (COMMENTS: STARTED AFTER DISCONTINUING 22-Feb-2006 08:20 AM Page: 178 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report RISPERDAL) Prozac (Fluoxetine) SS Ambien (Zolpidem) SS Date:03/12/98ISR Number: 3140381-2Report Type:Periodic Company Report #JAUSA-29093 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Health Risperdal PS Janssen ORAL 9 MG DAILY Muscle Contractions Professional ORAL Involuntary Date:03/12/98ISR Number: 3140384-8Report Type:Periodic Company Report #JAUSA-29096 Age:3 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Risperdal PS Janssen ORAL 1) .5 MG DAILY ORAL, 2) 1 MG DAILY ORAL 2 DAY Date:03/12/98ISR Number: 3140386-1Report Type:Periodic Company Report #JAUSA-29097 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Drug Interaction Professional ORAL Sedation Trazodone (Trazodone) SS 50 MG DAILY Aricept (Donepezil) SS 5 MG DAILY Date:03/12/98ISR Number: 3140390-3Report Type:Periodic Company Report #JAUSA-29098 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vomiting Health Risperdal PS Janssen ORAL ORAL Professional Depakote (Valproate Sodium) C Neurontin (Gabapentin) C Date:03/12/98ISR Number: 3140392-7Report Type:Periodic Company Report #JAUSA-29099 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Professional ORAL Date:03/12/98ISR Number: 3140466-0Report Type:Periodic Company Report #JAUSA-26983 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen ORAL 6 MG DAILY Initial or Prolonged Increased Appetite ORAL; 4 MG Sedation DAILY 7 WK Speech Disorder Olanzapine SS ORAL 10 MG DAILY 22-Feb-2006 08:20 AM Page: 179 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:03/12/98ISR Number: 3140469-6Report Type:Periodic Company Report #JAUSA-26985 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Urea Increased Health Risperdal PS Janssen ORAL .5 MG DAILY Hyperkalaemia Professional ORAL AT BEDTIME Luvox SS ORAL -,DAILY ORAL Dilantin C Micronase C Lisinopril C Date:03/12/98ISR Number: 3140471-4Report Type:Periodic Company Report #JAUSA-26986 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrasystoles Health Risperdal PS Janssen ORAL 2 MG 2 DAILY Professional ORAL Flagyl C Levsinex C Mag Oxide C Pepcid C Procardia C Tetracycline C Depakote C Date:03/12/98ISR Number: 3140473-8Report Type:Periodic Company Report #JAUSA-26987 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Retention Health Risperdal PS Janssen ORAL 2 MG DAILY Professional ORAL 1 WK Ativan C Date:03/12/98ISR Number: 3140475-1Report Type:Periodic Company Report #JAUSA-26990 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Retention Health Risperdal PS Janssen ORAL 3 MG ORAL; 2 Professional MG 1 WK Prozac C Date:03/12/98ISR Number: 3140477-5Report Type:Periodic Company Report #JAUSA-26991 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Risperdal PS Janssen ORAL 6 MG DAILY Hyperglycaemia ORAL Lithium C Synthroid C Artane C Klonopin C 22-Feb-2006 08:20 AM Page: 180 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3140478-7Report Type:Periodic Company Report #JAUSA-26992 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Dysphagia Professional ORAL Date:03/12/98ISR Number: 3140481-7Report Type:Periodic Company Report #JAUSA-26993 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Consumer Risperdal PS Janssen ORAL ORAL Tremor Date:03/12/98ISR Number: 3140484-2Report Type:Periodic Company Report #JAUSA-26997 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Risperdal PS Janssen ORAL -, ORAL; 4 MG 2 DAILY Date:03/12/98ISR Number: 3140486-6Report Type:Periodic Company Report #JAUSA-27000 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Risperdal PS Janssen ORAL 1 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3140490-8Report Type:Periodic Company Report #JAUSA-27002 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal PS Janssen ORAL 8 MG DAILY Drug Effect Decreased ORAL; 12 MG Hallucination, Auditory DAILY Date:03/12/98ISR Number: 3140492-1Report Type:Periodic Company Report #JAUSA-27003 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Professional ORAL Date:03/12/98ISR Number: 3140494-5Report Type:Periodic Company Report #JAUSA-27004 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Risperdal PS Janssen ORAL 4 MG DAILY Dizziness ORAL Nausea Navane C Salivary Hypersecretion Depo-Provera C Sedation Speech Disorder Vomiting 22-Feb-2006 08:20 AM Page: 181 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3140497-0Report Type:Periodic Company Report #JAUSA-27005 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Consumer Risperdal PS Janssen ORAL 3 MG DAILY ORAL Date:03/12/98ISR Number: 3140499-4Report Type:Periodic Company Report #JAUSA-27007 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Risperdal PS Janssen ORAL 12 MG DAILY Initial or Prolonged Back Pain ORAL Extrapyramidal Disorder Ritalin SS Date:03/12/98ISR Number: 3140501-XReport Type:Periodic Company Report #JAUSA-27008 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal PS Janssen ORAL -, ORAL Professional Date:03/12/98ISR Number: 3140504-5Report Type:Periodic Company Report #JAUSA-27015 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL -, ORAL Professional Date:03/12/98ISR Number: 3140506-9Report Type:Periodic Company Report #JAUSA-27016 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 5 MG DAILY Professional ORAL; 2 MG IN AM, 3 MG IN PM Date:03/12/98ISR Number: 3140509-4Report Type:Periodic Company Report #JAUSA-27018 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL -, DAILY ORAL Professional Date:03/12/98ISR Number: 3140511-2Report Type:Periodic Company Report #JAUSA-27020 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL 5 MG 2 DAILY Hyperprolactinaemia Professional ORAL Depakote C Lithium C 22-Feb-2006 08:20 AM Page: 182 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3140513-6Report Type:Periodic Company Report #JAUSA-26938 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Consumer Risperdal Drug Abuser (Risperidone) PS Janssen ORAL ORAL Dyspnoea Effexor Hyperhidrosis (Venlafexine) SS ORAL ORAL Sedation Tachycardia Date:03/12/98ISR Number: 3140515-XReport Type:Periodic Company Report #JAUSA-26946 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Risperdal Initial or Prolonged Gait Disturbance (Risperidone) PS Janssen ORAL 2MG DAILY Hyperprolactinaemia ORAL Muscle Contractions Involuntary Pituitary Tumour Benign Urinary Incontinence Date:03/12/98ISR Number: 3140517-3Report Type:Periodic Company Report #JAUSA-26947 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Risperdal Professional (Risperidone) PS Janssen ORAL DAILY ORAL Date:03/12/98ISR Number: 3140519-7Report Type:Periodic Company Report #JAUSA-26949 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Health Risperdal Professional (Risperidone) PS Janssen ORAL DAILY ORAL Date:03/12/98ISR Number: 3140521-5Report Type:Periodic Company Report #JAUSA-26950 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal Initial or Prolonged Professional (Risperidone) PS Janssen ORAL DAILY ORAL Date:03/12/98ISR Number: 3140523-9Report Type:Periodic Company Report #JAUSA-26951 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Professional (Risdperidone) PS Janssen ORAL .5MG 1 DAILY ORAL 22-Feb-2006 08:20 AM Page: 183 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3140526-4Report Type:Periodic Company Report #JAUSA-26963 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone) PS Janssen ORAL 4MG DAILY ORAL,6MG DAILY Tegretol C Date:03/12/98ISR Number: 3140529-XReport Type:Periodic Company Report #JAUSA-26965 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ear Pain Consumer Risperdal (Risperidone) PS Janssen ORAL 4MG DAILY ORAL Cogentin C Clonopin C Date:03/12/98ISR Number: 3140531-8Report Type:Periodic Company Report #JAUSA-26966 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal Professional (Risperidone) PS Janssen ORAL 1MG DAILY ORAL Date:03/12/98ISR Number: 3140538-0Report Type:Periodic Company Report #JAUSA-26967 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal Professional (Risperidone) PS Janssen ORAL 2MG DAILY ORAL Date:03/12/98ISR Number: 3140541-0Report Type:Periodic Company Report #JAUSA-26969 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Tremor Professional (Risperidone) PS Janssen ORAL 6MG DAILY ORAL Cogentin C Date:03/12/98ISR Number: 3140543-4Report Type:Periodic Company Report #JAUSA-26970 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone) PS Janssen ORAL 4MG DAILY ORAL 22-Feb-2006 08:20 AM Page: 184 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3140546-XReport Type:Periodic Company Report #JAUSA-26971 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone) PS Janssen ORAL DAILY ORAL Date:03/12/98ISR Number: 3140549-5Report Type:Periodic Company Report #JAUSA-26972 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone) PS Janssen ORAL 4MG DAILY ORAL Date:03/12/98ISR Number: 3140551-3Report Type:Periodic Company Report #JAUSA-26975 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Drug Abuser (Risperidone) PS Janssen ORAL DAILY ORAL Date:03/12/98ISR Number: 3140553-7Report Type:Periodic Company Report #JAUSA-26977 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Consumer Risperdal Involuntary (Risperidone) PS Janssen ORAL 1MG DAILY ORAL,2MG DAILY Prozac C Ritalin C Date:03/12/98ISR Number: 3140557-4Report Type:Periodic Company Report #JAUSA-26978 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Eye Disorder Professional (Risperidone) PS Janssen ORAL 2MG 2 DAILY ORAL Date:03/12/98ISR Number: 3140560-4Report Type:Periodic Company Report #JAUSA-26979 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Consumer Risperdal (Risperidone) PS Janssen ORAL 1.5MG DAILY ORAL Haldol C Cogentin C Clonopin C 22-Feb-2006 08:20 AM Page: 185 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3140561-6Report Type:Periodic Company Report #JAUSA-26980 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Syncope Health Risperdal Professional (Risperidone) PS Janssen ORAL 6MG DAILY ORAL, 4MG DAILY Prozac C Date:03/12/98ISR Number: 3140563-XReport Type:Periodic Company Report #JAUSA-26981 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Risperdal (Risperidone) PS Janssen ORAL DAILY ORAL Prolixin C Date:03/12/98ISR Number: 3140873-6Report Type:Periodic Company Report #JAUSA-29442 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Risperdal PS ORAL 2 MG 2 DAILY Initial or Prolonged Phosphokinase Increased Professional ORAL Hypertonia Risperdal SS Pyrexia Lithium C Ativan C Date:03/12/98ISR Number: 3140875-XReport Type:Periodic Company Report #JAUSA-29463 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delirium Risperdal PS ORAL ORAL Unspecified C Date:03/12/98ISR Number: 3140878-5Report Type:Periodic Company Report #JAUSA-29465 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Risperdal PS ORAL 180 MG SINGLE Therapeutic Response Professional ORAL Increased Date:03/12/98ISR Number: 3140880-3Report Type:Periodic Company Report #JAUSA-29467 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sarcoidosis Health Risperdal PS Professional Date:03/12/98ISR Number: 3140882-7Report Type:Periodic Company Report #JAUSA-29469 Age:58 YR Gender:Female I/FU:I Outcome PT Other Abdominal Pain Convulsion 22-Feb-2006 08:20 AM Page: 186 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Report Source Product Role Manufacturer Route Dose Duration Study Risperdal PS ORAL PM ORAL Health Levsinex SS ORAL ORAL Professional Levsinex SS Date:03/12/98ISR Number: 3140884-0Report Type:Periodic Company Report #JAUSA-29470 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Health Risperdal PS ORAL 1 MG DAILY Hypercholesterolaemia Professional ORAL Hypertriglyceridaemia Risperdal SS Date:03/12/98ISR Number: 3140887-6Report Type:Periodic Company Report #JAUSA-29475 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Professional ORAL Ambien C Klonopin C Date:03/12/98ISR Number: 3140889-XReport Type:Periodic Company Report #JAUSA-29478 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen ORAL 6 MG DAILY Initial or Prolonged Fatigue ORAL Headache Risperdal SS ORAL 6 MG DAILY Insomnia ORAL Tremor Congentin C Visual Disturbance Date:03/12/98ISR Number: 3140892-XReport Type:Periodic Company Report #JAUSA-29486 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neurosis Health Risperdal PS Janssen ORAL 5 MG DAILY Professional ORAL Risperdal SS Symmetrel C Anafranil C Date:03/12/98ISR Number: 3140894-3Report Type:Periodic Company Report #JAUSA-29499 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cyanosis Health Risperdal PS Janssen ORAL 5 MG 2 DAILY Hypotension Professional ORAL Sedation Risperdal SS Lanoxin C Inderal C Axid C 22-Feb-2006 08:20 AM Page: 187 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3140896-7Report Type:Periodic Company Report #JAUSA-29502 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Health Risperdal PS ORAL 4 MG 2 DAILY Weight Increased Professional ORAL Date:03/12/98ISR Number: 3140898-0Report Type:Periodic Company Report #JAUSA-29524 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Consumer Risperdal PS Janssen ORAL 1 MG 2 DAILY ORAL Cylert SS ORAL 18.75 MG 3 DAILY ORAL Xanax C Welbutrin C Date:03/12/98ISR Number: 3140901-8Report Type:Periodic Company Report #JAUSA-29525 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS ORAL DAILY ORAL Galactorrhoea Risperdal SS Visual Disturbance Date:03/12/98ISR Number: 3140903-1Report Type:Periodic Company Report #JAUSA-29528 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alkaline Health Risperdal PS ORAL 2 MG DAILY Phosphatase Increased Professional ORAL Jaundice Risperdal SS Date:03/12/98ISR Number: 3140905-5Report Type:Periodic Company Report #JAUSA-29531 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS ORAL 6 MG DAILY Hyperprolactinaemia ORAL Date:03/12/98ISR Number: 3140906-7Report Type:Periodic Company Report #JAUSA-29532 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Discharge Health Risperdal PS ORAL 1 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3140907-9Report Type:Periodic Company Report #JAUSA-29533 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal PS ORAL 2 MG DAILY Erectile Dysfunction ORAL 22-Feb-2006 08:20 AM Page: 188 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3140914-6Report Type:Periodic Company Report #JAUSA-29534 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Risperdal PS ORAL 3 MG DAILY Hypotension Professional ORAL Hypothermia Nitroglycerin C Date:03/12/98ISR Number: 3140915-8Report Type:Periodic Company Report #JAUSA-29537 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Consumer Risperdal PS ORAL 1 MG DAILY Cough ORAL Dizziness Increased Appetite Tremor Date:03/12/98ISR Number: 3140917-1Report Type:Periodic Company Report #JAUSA-29612 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Health Risperdal PS Janssen ORAL ORAL Tremor Neonatal Professional Sertraline C Date:03/12/98ISR Number: 3140919-5Report Type:Periodic Company Report #JAUSA-29613 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cough Health Risperdal PS Janssen ORAL PM ORAL Nausea Professional Tegretol C Sedation Date:03/12/98ISR Number: 3140965-1Report Type:Periodic Company Report #JAUSA-27024 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL DAILY ORAL Pituitary Tumour Benign Date:03/12/98ISR Number: 3140967-5Report Type:Periodic Company Report #JAUSA-27025 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Pituitary Tumour Benign Professional (Risperidone) PS Janssen ORAL DAILY ORAL Date:03/12/98ISR Number: 3141402-3Report Type:Periodic Company Report #JAUSA-27026 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL DAILY ORAL Hypothyroidism Pituitary Tumour Benign 22-Feb-2006 08:20 AM Page: 189 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3141405-9Report Type:Periodic Company Report #JAUSA-27027 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Risperdal Respiratory Disorder Professional (Risperidone) PS Janssen ORAL 2 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3141407-2Report Type:Periodic Company Report #JAUSA-27032 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pain In Extremity Consumer Risperdal Tremor (Risperidone) PS Janssen ORAL DAILY ORAL Synthroid C Nortriptyline C Pamelor C Lithium C Date:03/12/98ISR Number: 3141411-4Report Type:Periodic Company Report #JAUSA-27034 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Hyperprolactinaemia (Risperidone) PS Janssen ORAL 4 MG DAILY Nightmare ORAL Effexor C Ritalin C Date:03/12/98ISR Number: 3141414-XReport Type:Periodic Company Report #JAUSA-27036 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Risperdal Fatigue (Risperidone) PS Janssen ORAL 1 MG DAILY Sedation ORAL Lithium C Date:03/12/98ISR Number: 3141419-9Report Type:Periodic Company Report #JAUSA-27039 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Drug Interaction Professional (Risperidone) PS Janssen ORAL 2.5 MG DAILY ORAL-DAILY ORAL CAPSULES Chemet C Date:03/12/98ISR Number: 3141421-7Report Type:Periodic Company Report #JAUSA-27041 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal PS ORAL 1 MG DAILY ORAL Dexedrine (Dexamphetamine) C Zoloft (Sertraline) C 22-Feb-2006 08:20 AM Page: 190 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3141424-2Report Type:Periodic Company Report #JAUSA-27042 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Consumer Risperdal PS Janssen ORAL DAILY ORAL Pituitary Tumour Date:03/12/98ISR Number: 3141428-XReport Type:Periodic Company Report #JAUSA-27044 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Health Risperdal PS Janssen ORAL DAILY ORAL Professional Date:03/12/98ISR Number: 3141498-9Report Type:Periodic Company Report #JAUSA-27046 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone) PS Janssen ORAL DAILY ORAL Date:03/12/98ISR Number: 3141501-6Report Type:Periodic Company Report #JAUSA-27047 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal Thrombocytopenia Professional (Risperidone) PS Janssen ORAL 6 MG DAILY ORAL Date:03/12/98ISR Number: 3141503-XReport Type:Periodic Company Report #JAUSA-27049 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL DAILY ORAL Date:03/12/98ISR Number: 3141504-1Report Type:Periodic Company Report #JAUSA-27136 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Malaise Risperdal PS Janssen ORAL 4MG DAILY ORAL Date:03/12/98ISR Number: 3141505-3Report Type:Periodic Company Report #JAUSA-27050 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL DAILY ORAL 22-Feb-2006 08:20 AM Page: 191 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3141507-7Report Type:Periodic Company Report #JAUSA-27138 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal PS Janssen ORAL 1MG DAILY Visual Disturbance ORAL Haldol C Date:03/12/98ISR Number: 3141508-9Report Type:Periodic Company Report #JAUSA-27051 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Professional (Risperidone) PS Janssen ORAL DAILY ORAL Date:03/12/98ISR Number: 3141509-0Report Type:Periodic Company Report #JAUSA-27140 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Consumer Risperdal PS Janssen ORAL 1MG DAILY Muscle Contractions ORAL Involuntary Tylenol C Tinnitus Relafen C Date:03/12/98ISR Number: 3141510-7Report Type:Periodic Company Report #JAUSA-27053 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3141512-0Report Type:Periodic Company Report #JAUSA-27054 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone) PS Janssen ORAL 6 MG DAILY ORAL Date:03/12/98ISR Number: 3141513-2Report Type:Periodic Company Report #JAUSA-27141 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal PS Janssen ORAL 4MG DAILY Professional ORAL Cogentin C Elavil C Klonopin C Thiamine C Date:03/12/98ISR Number: 3141514-4Report Type:Periodic Company Report #JAUSA-27055 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Consumer Risperdal (Risperidone) PS Janssen ORAL DAILY ORAL 22-Feb-2006 08:20 AM Page: 192 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Norvasc C Accupril C Date:03/12/98ISR Number: 3141515-6Report Type:Periodic Company Report #JAUSA-27146 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Health Risperdal PS Janssen ORAL -, DAILY ORAL Hypertonia Professional Haldol C Injury Klonopin C Salivary Hypersecretion Lopressor C Sedation Apresoline C Date:03/12/98ISR Number: 3141517-XReport Type:Periodic Company Report #JAUSA-27149 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Risperdal PS Janssen ORAL 4MG DAILY Initial or Prolonged Phosphokinase Increased Professional ORAL Convulsion Wellbutrin C Hyponatraemia Date:03/12/98ISR Number: 3141519-3Report Type:Periodic Company Report #JAUSA-27152 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL -, ORAL, 6MG Galactorrhoea Professional DAILY ORAL Hyperprolactinaemia Date:03/12/98ISR Number: 3141522-3Report Type:Periodic Company Report #JAUSA-27056 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Risperdal Speech Disorder (Risperidone) PS Janssen ORAL 4 MG DAILY ORAL - 6 MG DAILY ORAL Serzone C Date:03/12/98ISR Number: 3141525-9Report Type:Periodic Company Report #JAUSA-27157 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Risperdal PS Janssen ORAL -, ORAL Professional Date:03/12/98ISR Number: 3141528-4Report Type:Periodic Company Report #JAUSA-27158 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acne Health Risperdal PS Janssen ORAL -, ORAL Professional 22-Feb-2006 08:20 AM Page: 193 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3141532-6Report Type:Periodic Company Report #JAUSA-27181 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Study Risperdal PS Janssen ORAL DAILY ORAL Life-Threatening Health Trilafon C Professional Amantadine C Bupropion C Lithium C Date:03/12/98ISR Number: 3141537-5Report Type:Periodic Company Report #JAUSA-27183 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Consumer Risperdal PS Janssen ORAL 2MG DAILY Initial or Prolonged Malaise ORAL, 4MG DAILY ORAL 18 MON Date:03/12/98ISR Number: 3141544-2Report Type:Periodic Company Report #JAUSA-27233 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Risperdal PS Janssen ORAL 3MG DAILY Initial or Prolonged Visual Disturbance Professional ORAL, 1MG A.M, 2MG H.S. Date:03/12/98ISR Number: 3141547-8Report Type:Periodic Company Report #JAUSA-27236 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Consumer Risperdal PS Janssen ORAL 3MG 2 DAILY Initial or Prolonged Hepatic Function Abnormal ORAL Weight Increased Date:03/12/98ISR Number: 3141548-XReport Type:Periodic Company Report #JAUSA-27245 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhinitis Health Risperdal PS Janssen ORAL -, ORAL Professional Date:03/12/98ISR Number: 3141551-XReport Type:Periodic Company Report #JAUSA-27247 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tooth Disorder Health Risperdal PS Janssen ORAL -, ORAL Professional Date:03/12/98ISR Number: 3141554-5Report Type:Periodic Company Report #JAUSA-27248 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Pain Consumer Risperdal PS Janssen ORAL 2MG 2 DAILY Visual Disturbance ORAL, 1MG 2 DAILY Zyrtec C 22-Feb-2006 08:20 AM Page: 194 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3141556-9Report Type:Periodic Company Report #JAUSA-27250 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal PS Janssen ORAL 1MG 2 DAILY Deficit/Hyperactivity Professional ORAL Disorder Extrapyramidal Disorder Date:03/12/98ISR Number: 3141557-0Report Type:Periodic Company Report #JAUSA-27251 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal PS Janssen ORAL 2MG 2 DAILY Deficit/Hyperactivity Professional ORAL Disorder Extrapyramidal Disorder Date:03/12/98ISR Number: 3141559-4Report Type:Periodic Company Report #JAUSA-27252 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Stridor Health Risperdal PS Janssen ORAL -, ORAL Professional Date:03/12/98ISR Number: 3141562-4Report Type:Periodic Company Report #JAUSA-27255 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Consumer Risperdal PS Janssen ORAL 4MG DAILY Muscle Contractions ORAL Involuntary Trazodone C Pain Date:03/12/98ISR Number: 3142647-9Report Type:Periodic Company Report #JAUSA-27057 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothermia Health Risperdal PS ORAL 2 MG DAILY Professional Date:03/12/98ISR Number: 3142649-2Report Type:Periodic Company Report #JAUSA-27059 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal PS ORAL 2 MG DAILY Professional Date:03/12/98ISR Number: 3142651-0Report Type:Periodic Company Report #JAUSA-27062 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal PS ORAL Professional 22-Feb-2006 08:20 AM Page: 195 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3142653-4Report Type:Periodic Company Report #JAUSA-27063 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tongue Discolouration Health Risperdal PS ORAL DAILY Professional Date:03/12/98ISR Number: 3142655-8Report Type:Periodic Company Report #JAUSA-27064 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal PS ORAL 3 MG DAILY Professional Zantac (Ranitidine) C Date:03/12/98ISR Number: 3142656-XReport Type:Periodic Company Report #JAUSA-27065 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Consumer Risperdal PS ORAL 6 MG DAILY Pain In Extremity Lithium (Lithium) C Sedation Date:03/12/98ISR Number: 3142658-3Report Type:Periodic Company Report #JAUSA-27066 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS ORAL 4 MG DAILY Professional Date:03/12/98ISR Number: 3142660-1Report Type:Periodic Company Report #JAUSA-27067 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Engorgement Health Risperdal PS ORAL 1 MG DAILY Galactorrhoea Professional Zoloft (Sertraline) C Weight Increased Adderall (-) C Date:03/12/98ISR Number: 3142662-5Report Type:Periodic Company Report #JAUSA-27070 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risderal PS ORAL DAILY Professional Ritalin (Methylphenidate) C Date:03/12/98ISR Number: 3142664-9Report Type:Periodic Company Report #JAUSA-27071 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS ORAL 3 MG DAILY Hyperprolactinaemia Professional Myalgia 22-Feb-2006 08:20 AM Page: 196 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3142665-0Report Type:Periodic Company Report #JAUSA-27073 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspartate Consumer Risperdal PS ORAL 1 MG DAILY Aminotransferase Increased Date:03/12/98ISR Number: 3142667-4Report Type:Periodic Company Report #JAUSA-27074 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS ORAL 9 MG DAILY Professional Zoloft (Sertraline) C Date:03/12/98ISR Number: 3142669-8Report Type:Periodic Company Report #JAUSA-27075 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Risperdal PS ORAL 4 MG DAILY Professional Date:03/12/98ISR Number: 3142671-6Report Type:Periodic Company Report #JAUSA-27076 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Increased Appetite Consumer Risperdal PS ORAL 1 MG DAILY Weight Increased Date:03/12/98ISR Number: 3142673-XReport Type:Periodic Company Report #JAUSA-27082 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS ORAL 3 MG 2 DAILY Galactorrhoea Professional Eskalith (Lithium) C Hyperprolactinaemia Date:03/12/98ISR Number: 3142675-3Report Type:Periodic Company Report #JAUSA-27084 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal PS ORAL 10 MG DAILY Haldol (Haloperidol) C Loxitane (Loxapine) C Cogentin (Benztropine) C Ativan (Lorazepam) C Date:03/12/98ISR Number: 3142677-7Report Type:Periodic Company Report #JAUSA-27085 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Risperdal PS ORAL 3 MG 2 DAILY Initial or Prolonged Health Elavil SS ORAL 150 MG DAILY Professional Haldol (Haloperidol) C Prozac (Fluoxetine) C 22-Feb-2006 08:20 AM Page: 197 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin (Benztropine) C Bactrim Ds (Bactrim Ds (R) ) C Depakote (Valproate Sodium) C Date:03/12/98ISR Number: 3142679-0Report Type:Periodic Company Report #JAUSA-27092 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS ORAL Professional Date:03/12/98ISR Number: 3142681-9Report Type:Periodic Company Report #JAUSA-27126 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Consumer Risperdal PS ORAL 1 MG 3 DAILY Flushing Depakote (Valproate Hyperhidrosis Sodium) C Hypertonia Valium (Diazepam) C Pain Depo-Provera (Medroxyprogesterone ) C Bactrim (Bactrim (R) ) C Prilosec (Omeprazole) C Date:03/12/98ISR Number: 3142683-2Report Type:Periodic Company Report #JAUSA-27130 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Risperdal PS ORAL 6 MG DAILY Professional Date:03/12/98ISR Number: 3144345-4Report Type:Periodic Company Report #JAUSA-29081 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Riisperdal PS Janssen ORAL 3 MG 2 DAILY ORAL ( 1 MG IN MORNING AND 2 MG IN EVENING) Depakote (Valproate Sodium) C Diabeta (Glibenclamide) C Aspirin (Acetylsalicylic-Aci d) C Zocor (Simvastatin) C 22-Feb-2006 08:20 AM Page: 198 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3144686-0Report Type:Periodic Company Report #JAUSA-29100 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glaucoma Health Risperdal PS Janssen ORAL 2MG 1 DAILY Professional ORAL Lithium C Date:03/12/98ISR Number: 3144688-4Report Type:Periodic Company Report #JAUSA-29102 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Consumer Risperdal PS Janssen ORAL 1.5MG 2 DAILY Vomiting ORAL Tegretol SS ORAL -, DAILY ORAL Lamictal C Date:03/12/98ISR Number: 3144690-2Report Type:Periodic Company Report #JAUSA-29103 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysuria Consumer Risperdal PS Janssen ORAL 4MG DAILY Ejaculation Failure ORAL Rhinocort C Date:03/12/98ISR Number: 3144692-6Report Type:Periodic Company Report #JAUSA-29105 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Consumer Risperdal PS Janssen ORAL 2MG 2 DAILY Deficit/Hyperactivity ORAL Disorder Chlorpromazine C Constipation Date:03/12/98ISR Number: 3144695-1Report Type:Periodic Company Report #JAUSA-29107 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Health Risperdal PS ORAL 2MG DAILY Professional ORAL Desyrel C Trilafon C Xanax C Luvox C Date:03/12/98ISR Number: 3144698-7Report Type:Periodic Company Report #JAUSA-29108 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal PS Janssen ORAL 2MG 2 DAILY Professional ORAL Insulin C Remeron C Ativan C Iron C Questran C Lopid C 22-Feb-2006 08:20 AM Page: 199 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3144703-8Report Type:Periodic Company Report #JAUSA-29109 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal PS Janssen ORAL 2MG DAILY Salivary Hypersecretion Professional ORAL, 1MG DAILY ORAL Date:03/12/98ISR Number: 3144716-6Report Type:Periodic Company Report #JAUSA-29110 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL .5MG 2 DAILY Weight Increased Professional ORAL Luvox C Date:03/12/98ISR Number: 3144718-XReport Type:Periodic Company Report #JAUSA-29111 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS Janssen ORAL 4MG 2 DAILY Hyperprolactinaemia ORAL Prozac C Cogentin C Wellbutrin C Date:03/12/98ISR Number: 3144722-1Report Type:Periodic Company Report #JAUSA-29112 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal PS Janssen ORAL 1MG 2 DAILY Hyperprolactinaemia Professional ORAL Date:03/12/98ISR Number: 3144725-7Report Type:Periodic Company Report #JAUSA-29113 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal PS Janssen ORAL 1MG 2 DAILY Professional ORAL Depakote C Effexor C Date:03/12/98ISR Number: 3144727-0Report Type:Periodic Company Report #JAUSA-29114 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Risperdal PS Janssen ORAL 1MG 1 DAILY Chest Pain Professional ORAL, 2MG 2 Hypertension DAILY ORAL Remeron C Hydralazine C Biotin C Serzone C 22-Feb-2006 08:20 AM Page: 200 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3144730-0Report Type:Periodic Company Report #JAUSA-29115 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal PS Janssen ORAL 3MG DAILY Orthostatic Hypotension Professional ORAL, 1MG 2 DAILY ORAL Zoloft C Date:03/12/98ISR Number: 3144734-8Report Type:Periodic Company Report #JAUSA-29116 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Jannsen ORAL 1MG 2 DAILY Professional ORAL Date:03/12/98ISR Number: 3144738-5Report Type:Periodic Company Report #JAUSA-29117 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL .5MG 2 DAILY Professional ORAL Date:03/12/98ISR Number: 3144741-5Report Type:Periodic Company Report #JAUSA-29118 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL 1.5MG DAILY Professional ORAL Trazone C Date:03/12/98ISR Number: 3144746-4Report Type:Periodic Company Report #JAUSA-29120 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Consumer Risperdal PS Janssen ORAL 3MG DAILY ORAL Date:03/12/98ISR Number: 3144750-6Report Type:Periodic Company Report #JAUSA-29121 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Productive Cough Consumer Risperdal PS Janssen ORAL 05MG 2 DAILY Salivary Hypersecretion ORAL Sedation Aricept C Prozac C Iron C Colace C Ecotrin C Date:03/12/98ISR Number: 3144753-1Report Type:Periodic Company Report #JAUSA-29123 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 1.5MG DAILY Professional ORAL 22-Feb-2006 08:20 AM Page: 201 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3144755-5Report Type:Periodic Company Report #JAUSA-29126 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vomiting Health Risperdal PS Janssen ORAL 4MG DAILY Professional ORAL Date:03/12/98ISR Number: 3144762-2Report Type:Periodic Company Report #JAUSA-29355 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Engorgement Health Risperdal Electrocardiogram Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY Abnormal ORAL Galactorrhoea Tachycardia Date:03/12/98ISR Number: 3144767-1Report Type:Periodic Company Report #JAUSA-29358 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone) PS Janssen ORAL 3 MG 2 X DAILY ORAL Date:03/12/98ISR Number: 3144769-5Report Type:Periodic Company Report #JAUSA-29360 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone) PS Janssen ORAL 5 MG 3 X DAILY ORAL Date:03/12/98ISR Number: 3144774-9Report Type:Periodic Company Report #JAUSA-29361 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone) PS Janssen ORAL 2 MG 3 TIMES DAILY ORAL Date:03/12/98ISR Number: 3144777-4Report Type:Periodic Company Report #JAUSA-29365 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL ORAL Weight Increased Date:03/12/98ISR Number: 3144781-6Report Type:Periodic Company Report #JAUSA-29366 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Nervousness (Risperidone) PS Janssen ORAL .5 MG 2 DAILY ORAL 22-Feb-2006 08:20 AM Page: 202 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3144788-9Report Type:Periodic Company Report #JAUSA-29368 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL; SPORADIC THERAPY USE Date:03/12/98ISR Number: 3144810-XReport Type:Periodic Company Report #JAUSA-29370 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Consumer Risperdal (Risperidone) PS ORAL 3 MG DAILY ORAL Date:03/12/98ISR Number: 3144812-3Report Type:Periodic Company Report #JAUSA-29371 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3144822-6Report Type:Periodic Company Report #JAUSA-29374 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Malaise Health Rispersal Pyrexia Professional (Risperidone) PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3144824-XReport Type:Periodic Company Report #JAUSA-29384 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Consumer Risperdal Palpitations (Risperidone) PS Janssen ORAL 8 MG DAILY ORAL Date:03/12/98ISR Number: 3144825-1Report Type:Periodic Company Report #JAUSA-29386 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Risperdal Prothrombin Level Professional (Risperidone) PS Janssen ORAL 1 MG DAILY Decreased ORAL; DRUG STOPPED, THEN RESTARTED AND INCREASED Coumadin (Warfarin) SS 22-Feb-2006 08:20 AM Page: 203 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3144826-3Report Type:Periodic Company Report #JAUSA-29398 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Withdrawal Arrhythmia Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3144827-5Report Type:Periodic Company Report #JAUSA-29399 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal Professional (Risperidone) PS Janssen ORAL 6 MG DAILY ORAL Date:03/12/98ISR Number: 3144830-5Report Type:Periodic Company Report #JAUSA-29405 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thyroid Disorder Consumer Risperdal (Risperidone) PS Janssen ORAL .5 MG 2 TIME DAILY ORAL Date:03/12/98ISR Number: 3144832-9Report Type:Periodic Company Report #JAUSA-29408 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal Deficit/Hyperactivity Professional (Risperidone) PS Janssen ORAL ORAL Disorder Date:03/12/98ISR Number: 3144833-0Report Type:Periodic Company Report #JAUSA-29409 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal Deficit/Hyperactivity Professional (Risperidone) PS Janssen ORAL ORAL Disorder Date:03/12/98ISR Number: 3144834-2Report Type:Periodic Company Report #JAUSA-29419 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Risperdal Condition Aggravated (Risperidone) PS Janssen ORAL 3 MG DAILY Weight Increased ORAL Date:03/12/98ISR Number: 3144836-6Report Type:Periodic Company Report #JAUSA-29420 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 1 MG 2 X DAILY ORAL Dilantin (Phenytoin) C Paxil (Paroxetine) C 22-Feb-2006 08:20 AM Page: 204 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamins, Unspecified C Date:03/12/98ISR Number: 3144837-8Report Type:Periodic Company Report #JAUSA-29435 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pollakiuria Health Risperdal Urinary Incontinence Professional (Risperidone) PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3144883-4Report Type:Periodic Company Report #JAUSA-29261 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS Janssen ORAL 6 MG DAILY ORAL Date:03/12/98ISR Number: 3144885-8Report Type:Periodic Company Report #JAUSA-29263 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal PS Janssen ORAL 1 MG DAILY Professional ORAL .5 MG DAILY Serzone SS 100 MG DAILY Date:03/12/98ISR Number: 3144886-XReport Type:Periodic Company Report #JAUSA-29266 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal PS Janssen ORAL 8 MG DAILY Deficit/Hyperactivity Professional ORAL 7 MG Disorder DAILY Dyskinesia Weight Increased Date:03/12/98ISR Number: 3144888-3Report Type:Periodic Company Report #JAUSA-29267 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Professional ORAL Date:03/12/98ISR Number: 3144890-1Report Type:Periodic Company Report #JAUSA-29270 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Extrasystoles Professional ORAL Hypotension Buspar SS 7.5 MG 2 DAILY Lotensin SS 20 MG 2 DAILY Norvasc SS 22-Feb-2006 08:20 AM Page: 205 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3144892-5Report Type:Periodic Company Report #JAUSA-29273 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Risperdal PS Janssen ORAL 2 MG 2 DAILY Hyperprolactinaemia Professional ORAL Date:03/12/98ISR Number: 3144897-4Report Type:Periodic Company Report #JAUSA-29277 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vomiting Consumer Risperdal PS Janssen ORAL 2 MG DAILY ORAL DOSE TITRATED DOWN FROM 4 MG DAILY. Asa C Antacids C Date:03/12/98ISR Number: 3144900-1Report Type:Periodic Company Report #JAUSA-29279 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glycosuria Health Risperdal PS Janssen ORAL 2 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3144903-7Report Type:Periodic Company Report #JAUSA-29281 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Health Risperdal PS Janssen ORAL 3 MG DAILY Professional ORAL Date:03/12/98ISR Number: 3144904-9Report Type:Periodic Company Report #JAUSA-29282 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY Sedation ORAL Weight Increased Cogentin C Paxil C Date:03/12/98ISR Number: 3144906-2Report Type:Periodic Company Report #JAUSA-29283 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Consumer Risperdal PS Janssen ORAL 12 MG DAILY Sedation ORAL Lithium C Zoloft C Benadryl C 22-Feb-2006 08:20 AM Page: 206 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3144912-8Report Type:Periodic Company Report #JAUSA-29285 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL ORAL Hyperprolactinaemia Professional Zoloft C Depakote C Oral Contracept. Unsp C Date:03/12/98ISR Number: 3144915-3Report Type:Periodic Company Report #JAUSA-29289 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal PS Janssen ORAL 6 MG DAILY ORAL Lorazepam C Date:03/12/98ISR Number: 3144919-0Report Type:Periodic Company Report #JAUSA-29323 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY Initial or Prolonged Galactorrhoea ORAL Hyperprolactinaemia Klonopin C Date:03/12/98ISR Number: 3144921-9Report Type:Periodic Company Report #JAUSA-29328 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Phosphokinase Increased Professional ORAL Dystonia Ativan C Date:03/12/98ISR Number: 3144924-4Report Type:Periodic Company Report #JAUSA-29333 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY Initial or Prolonged ORAL Zyprexa SS ORAL ORAL Date:03/12/98ISR Number: 3144927-XReport Type:Periodic Company Report #JAUSA-29348 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyponatraemia Health Risperdal PS Janssen ORAL ORAL Thirst Professional Date:03/12/98ISR Number: 3144936-0Report Type:Periodic Company Report #JAUSA-29349 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal PS Janssen ORAL 4 MG DAILY Professional ORAL 6 MG DAILY 22-Feb-2006 08:20 AM Page: 207 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium C Cogentin C Date:03/12/98ISR Number: 3144938-4Report Type:Periodic Company Report #JAUSA-29350 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Risperdal PS Janssen ORAL 1 MG 3 DAILY Galactorrhoea Professional ORAL 1MG 2 Hypertrophy Breast DAILY Nightmare Cogentin C Visual Disturbance Anafranil C Date:03/12/98ISR Number: 3144940-2Report Type:Periodic Company Report #JAUSA-29352 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Health Risperdal PS Janssen ORAL 1.5 MG DAILY Professional ORAL 0.5 MG IN THE AM AND 1MG IN THE EVENING, Bactrim SS ORAL ORAL, DATES ESTIMATED. Paxil C Mvi C Asa C Date:03/12/98ISR Number: 3145876-3Report Type:Periodic Company Report #JAUSA-29127 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vomiting Health Risperdal(Risperidon Professional e),Janssen, Tablet PS Janssen ORAL 10 MG DAILY ORAL Date:03/12/98ISR Number: 3145877-5Report Type:Periodic Company Report #JAUSA-29129 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Consumer Risperdal(Risperidon Oedema e),Janssen, Tablet PS Janssen ORAL 1.5 MG DAILY Rhinitis ORAL Tremor Wellbutrin (Amfebutamone) C Klonopin (Clonazepam) C Buspar (Buspirone) C Xanax (Alprazolam) C Date:03/12/98ISR Number: 3145878-7Report Type:Periodic Company Report #JAUSA-29130 Age:39 YR Gender:Male I/FU:I Outcome PT Other Constipation Flatulence 22-Feb-2006 08:20 AM Page: 208 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Libido Decreased Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal(Risperidon e),Janssen, Tablet PS Janssen ORAL 4 MG DAILY ORAL Date:03/12/98ISR Number: 3145879-9Report Type:Periodic Company Report #JAUSA-29131 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Consumer Risperdal(Risperidon Libido Decreased e),Janssen, Tablet PS Janssen ORAL 4 MG DAILY ORAL Trazodone (Trazodone) C Date:03/12/98ISR Number: 3145880-5Report Type:Periodic Company Report #JAUSA-29132 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone),Jansse n, Tablet PS Janssen ORAL DAILY ORAL Date:03/12/98ISR Number: 3145881-7Report Type:Periodic Company Report #JAUSA-29133 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal(Risperidon Professional e),Janssen, Tablet PS Janssen ORAL DAILY ORAL Date:03/12/98ISR Number: 3145883-0Report Type:Periodic Company Report #JAUSA-29135 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Penis Disorder Health Risperdal Professional (Risperidone),Jansse n, Tablet PS Janssen ORAL .5 MG 1 DAILY ORAL; 1 MG 1 DAILY ORAL Paxil (Paroxetine) C Date:03/12/98ISR Number: 3145885-4Report Type:Periodic Company Report #JAUSA-29136 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dementia Health Risperdal Drug Interaction Professional (Risperidone),Jansse Sedation n, Tablet PS Janssen ORAL 1.5 MG DAILY Urinary Incontinence ORAL; .5 MG 2 DAILY ORAL Aricept (Donepezil) - SS ORAL 5 MG 1 DAILY ORAL 22-Feb-2006 08:20 AM Page: 209 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3145886-6Report Type:Periodic Company Report #JAUSA-29138 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysuria Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3145887-8Report Type:Periodic Company Report #JAUSA-29152 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal Initial or Prolonged Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG 2 DAILY ORAL; 1 MG 1 DAILY ORAL Nortriptyline (Nortriptyline) - SS ORAL 45 MG DAILY ORAL; 75 MG DAILY ORAL; 10 MG 2 DAILY ORAL 8 WK Tegretol (Carbamazepine) C Lactulose (Lactulose) C Date:03/12/98ISR Number: 3145896-9Report Type:Periodic Company Report #JAUSA-29154 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Consumer Risperdal Initial or Prolonged Hypertonia (Risperidone),Jansse Stupor n, Tablet PS Janssen ORAL 3 MG DAILY ORAL Ativan (Lorazepam) C Xanax (Alprazolam) C Date:03/12/98ISR Number: 3145901-XReport Type:Periodic Company Report #JAUSA-29157 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal(Risperidon Hypoaesthesia e),Janssen, Tablet PS Janssen ORAL 2 MG 2 DAILY Hypotension ORAL; .5 MG 2 Muscle Contractions DAILY ORAL Involuntary Corticosteroids (Corticosteroids) Ampule SS INTRAMUSCULAR SINGLE INTRAMUSCULAR Nortriptyline (Nortriptyline) C Premarin (Estrogens Conjugated) C Provera (Medroxyprogesterone ) C Azulfidine 22-Feb-2006 08:20 AM Page: 210 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Salazosulfapyridine ) C Nsaid Unspec (Nsaid Unspec) C Date:03/12/98ISR Number: 3145904-5Report Type:Periodic Company Report #JAUSA-29164 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pain Consumer Risperdal (Risperidone), Janssen, Tablet PS Janssen Date:03/12/98ISR Number: 3145906-9Report Type:Periodic Company Report #JAUSA-29165 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Depression (Risperidone),Jansse Dry Mouth n, Tablet PS Janssen ORAL 1 MG 2 DAILY Pollakiuria ORAL Urinary Tract Infection Depakote (Valproate Visual Disturbance Sodium) Tablet SS ORAL DAILY ORAL Date:03/12/98ISR Number: 3145910-0Report Type:Periodic Company Report #JAUSA-29167 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Speech Disorder Health Risperdal Tongue Oedema Professional (Risperidone),Jansse n, Tablet PS Janssen ORAL 1 MG 2 DAILY ORAL Stelazine (Trifluoperazine) C Cogentin (Benztropine) C Date:03/12/98ISR Number: 3145914-8Report Type:Periodic Company Report #JAUSA-29174 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paraesthesia Health Risperdal Professional (Risperidone),Jansse n, Tablet PS Janssen ORAL 1 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3145916-1Report Type:Periodic Company Report #JAUSA-29176 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal Professional (Risperidone),Jansse n, Tablet PS Janssen ORAL 1 MG 2 DAILY ORAL 22-Feb-2006 08:20 AM Page: 211 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3145918-5Report Type:Periodic Company Report #JAUSA-29206 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal Decreased Professional (Risperidone),Jansse Visual Disturbance n, Tablet PS Janssen ORAL 2 DAILY ORAL Date:03/12/98ISR Number: 3145919-7Report Type:Periodic Company Report #JAUSA-29254 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone),Jansse n, Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3145920-3Report Type:Periodic Company Report #JAUSA-29259 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Drug Interaction Professional (Risperidone),Jansse Drug Level Above n, Tablet PS Janssen ORAL 1 MG 1 DAILY Therapeutic ORAL Hyperprolactinaemia Depakote (Valproate Sodium) - SS 625 MG 3 DAILY - Date:03/12/98ISR Number: 3146478-5Report Type:Periodic Company Report #JAUSA-27398 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Extrapyramidal Disorder Professional (Risperidone), PS Janssen, ORAL 6 MG DAILY Paxil (Paroxetine) C Klonopin (Clonazepam) C Date:03/12/98ISR Number: 3146479-7Report Type:Periodic Company Report #JAUSA-27399 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Eye Pain (Risperidone), Headache Janssen, Tablet PS Janssen, ORAL 5.5 MG DAILY Nausea Klonopin C Pain Verapamil (Verapamil) C Ativan (Lorazepam) C Date:03/12/98ISR Number: 3146480-3Report Type:Periodic Company Report #JAUSA-27400 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal (Risperidone), Janssen, Tablet PS Janssen ORAL 22-Feb-2006 08:20 AM Page: 212 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3146481-5Report Type:Periodic Company Report #JAUSA-27401 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Consumer Risperdal Sedation (Risperidone), Janssen, Tablet PS ORAL .25 MG 1 WEEKLY Depakote (Valproate Sodium) Capsules SS ORAL 600 MG 1 DAILY Lasix (Furosemide) C Theo-Dur (Theophlline) C K-Dur (Potassium Chloride) C Date:03/12/98ISR Number: 3146483-9Report Type:Periodic Company Report #JAUSA-27402 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Risperdal Sedation (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG 1 DAILY Date:03/12/98ISR Number: 3146485-2Report Type:Periodic Company Report #JAUSA-27403 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG Date:03/12/98ISR Number: 3146487-6Report Type:Periodic Company Report #JAUSA-27404 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Consumer Risperdal Vomiting (Risperidone), Janssen, Tablet PS Janssen ORAL 3 MG 1 DAILY Date:03/12/98ISR Number: 3146489-XReport Type:Periodic Company Report #JAUSA-27415 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG DAILY Paxil (Paroxetine) C Depakote (Valproate Sodium) C Elavil (Amitriptyline) C 22-Feb-2006 08:20 AM Page: 213 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3146491-8Report Type:Periodic Company Report #JAUSA-27416 (E) Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blepharospasm Health Risperdal Muscle Contractions Professional (Reisperidone), Involuntary Jansse, Tablet PS Janssen ORAL 1 MG 1 DAILY Haldol C Date:03/12/98ISR Number: 3146493-1Report Type:Periodic Company Report #JAUSA-27417 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Cough Professional (Risperidone), Drug Effect Decreased Janssen, Tablet PS Janssen ORAL 6 MG 1 DAILY Rhinitis Date:03/12/98ISR Number: 3146495-5Report Type:Periodic Company Report #JAUSA-27420 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Purpura Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY Date:03/12/98ISR Number: 3146497-9Report Type:Periodic Company Report #JAUSA-27421 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperdal (Ridperidone), Janssen, Tablet PS Janssen ORAL 10 MG 1 DAILY Cogentin (Benztropine) C Depakote (Valproate Sodium) C Tylenol/Codeine (Tylenol/Codeine (R)) C Date:03/12/98ISR Number: 3146500-6Report Type:Periodic Company Report #JAUSA-27422 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Weight Increased (Risperidone), Janssen, Tablet PS Janssen ORAL 3 MG 1 DAILY Tegretol (Carbamazepine) C Date:03/12/98ISR Number: 3146503-1Report Type:Periodic Company Report #JAUSA-27423 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal Professional (Risperidone), 22-Feb-2006 08:20 AM Page: 214 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Janssen, Tablet PS Janssen ORAL Date:03/12/98ISR Number: 3146505-5Report Type:Periodic Company Report #JAUSA-27424 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Galactorrhoea Professional (Risperidone), Hyperprolactinaemia Janssen, Tablet PS Janssen ORAL 4 MG 1 DAILY Pituitary Tumour Benign Date:03/12/98ISR Number: 3146508-0Report Type:Periodic Company Report #JAUSA-27425 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1.5 MG 1 DAILY Date:03/12/98ISR Number: 3146510-9Report Type:Periodic Company Report #JAUSA-27426 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 3 MG 1 DAILY Effexor (Venlafexine) C Buspar (Buspirone) C Date:03/12/98ISR Number: 3146513-4Report Type:Periodic Company Report #JAUSA-27427 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Acute Health Risperdal Initial or Prolonged Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 DAILY Sinemet (Sinemet (R) ) C Date:03/12/98ISR Number: 3146514-6Report Type:Periodic Company Report #JAUSA-27428 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG DAILY Inderal (Propranolol) Tablet SS ORAL 20 MG 1 DAILY Zoloft (Sertraline) C Klonopin (Clonazepam) C 22-Feb-2006 08:20 AM Page: 215 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3146517-1Report Type:Periodic Company Report #JAUSA-27441 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal Deficit/Hyperactivity Professional (Risperidone), Disorder Janssen, Tablet PS Janssen ORAL 4 MG 1 DAILY Hyperglycaemia Benadryl Tremor (Diphenhydramine) C Date:03/12/98ISR Number: 3146548-1Report Type:Periodic Company Report #JAUSA-30391 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Risperdal Initial or Prolonged Confusional State Professional (Risperidone), Dizziness Janssen, Tablet PS Janssen ORAL 5 MG 2 DAILY Electrocardiogram Qt ORAL; 5MG 3 Prolonged DAILY Orthostatic Hypotension Thorazine C Pyrexia Paxil C Renal Impairment Capoten C Cogentin C Date:03/12/98ISR Number: 3146551-1Report Type:Periodic Company Report #JAUSA-30392 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nightmare Consumer Risperdal Palpitations (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3146556-0Report Type:Periodic Company Report #JAUSA-30394 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Consumer Risperdal Deficit/Hyperactivity (Risperidone), Disorder Janssen Tablet PS Janssen ORAL 1.5 MG DAILY Cough ORAL Prozac C Date:03/12/98ISR Number: 3146560-2Report Type:Periodic Company Report #JAUSA-30396 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 3 MG 2 DAILY ORAL 22-Feb-2006 08:20 AM Page: 216 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3146567-5Report Type:Periodic Company Report #JAUSA-30398 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Increased Appetite (Risperidone) Tachycardia Janssen, Tablet PS Janssen ORAL 1 MG DAILY Thirst ORAL Weight Increased Lithonate C Ortho C Date:03/12/98ISR Number: 3146582-1Report Type:Periodic Company Report #JAUSA-30400 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Consumer Risperdal Involuntary (Risperidone) Janssen, Tablet PS Janssen ORAL 2 MG 2 DAILY ORAL Tegretol C Depakote C Cylert C Date:03/12/98ISR Number: 3146586-9Report Type:Periodic Company Report #JAUSA-30407 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypokinesia Health Risperdal Professional (Risperidone) Janssen, Tablet PS Janssen ORAL 2 MG 1 DAILY ORAL, GIVEN AT HS Date:03/12/98ISR Number: 3146591-2Report Type:Periodic Company Report #JAUSA-30408 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Health Risperdal Involuntary Professional (Risperidone) Janssen, Tablet PS Janssen ORAL 3 MG 2 DAILY ORAL Prozac C Date:03/12/98ISR Number: 3146596-1Report Type:Periodic Company Report #JAUSA-30409 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sedation Health Risperdal Initial or Prolonged Stupor Professional (Risperidone) Janssen, Tablet PS Janssen ORAL 2 MG 2 DAILY ORAL Tegretol C 22-Feb-2006 08:20 AM Page: 217 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3146600-0Report Type:Periodic Company Report #JAUSA-30410 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal Professional (Risperidone) Janssen, Tablet PS Janssen ORAL 2 MG 1 DAILY ORAL Xanax C Date:03/12/98ISR Number: 3146605-XReport Type:Periodic Company Report #JAUSA-30433 Age:10 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Health Risperdal Involuntary Professional (Risperidone) Janssen, Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3146610-3Report Type:Periodic Company Report #JAUSA-30434 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Galactorrhoea Professional (Risperidone) Hyperprolactinaemia Janssen, Tablet PS Janssen ORAL 2 MG DAILY ORAL; 1.5MG DAILY; 1MG DAILY; 0.5MG DAILY Zoloft C Date:03/12/98ISR Number: 3146615-2Report Type:Periodic Company Report #JAUSA-30438 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Menstrual Disorder Health Risperdal Professional (Risperidone) Janssen, Tablet PS Janssen ORAL 1 MG ORAL Date:03/12/98ISR Number: 3146620-6Report Type:Periodic Company Report #JAUSA-30441 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Galactorrhoea Professional (Risperidone), Hyperprolactinaemia Janssen, Tablet PS Janssen ORAL 2 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3146623-1Report Type:Periodic Company Report #JAUSA-30442 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL 22-Feb-2006 08:20 AM Page: 218 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3146627-9Report Type:Periodic Company Report #JAUSA-30443 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hiccups Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG 2 DAILY ORAL; 1MG 1 DAILY, TAKEN AT BEDTIME Tegretol C Ativan C Chloral-Hydrate C Date:03/12/98ISR Number: 3146629-2Report Type:Periodic Company Report #JAUSA-30457 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Professional (Risperidone) Janssen, Tablet PS Janssen ORAL 3 MG DAILY ORAL Zoloft C Date:03/12/98ISR Number: 3146632-2Report Type:Periodic Company Report #JAUSA-30460 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Professional (Risperidone) Janssen, Tablet PS Janssen ORAL 1 MG 2 DAILY ORAL Paxil C Date:03/12/98ISR Number: 3146638-3Report Type:Periodic Company Report #JAUSA-27443 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Consumer Risperdal Deficit/Hyperactivity (Risperidone) PS Janssen ORAL SEE IMAGE Disorder Condition Aggravated Disturbance In Attention Erectile Dysfunction Hypertonia Palpitations Date:03/12/98ISR Number: 3146642-5Report Type:Periodic Company Report #JAUSA-27496 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal Initial or Prolonged Injury Professional (Risperidone) PS Janssen ORAL SEE IMAGE Tardive Dyskinesia Cogentin C 22-Feb-2006 08:20 AM Page: 219 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3146645-0Report Type:Periodic Company Report #JAUSA-27499 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Risperdal Initial or Prolonged Convulsion (Risperidone) PS Janssen ORAL 3 MG 2 DAILY Salivary Hypersecretion ORAL Dilantin C Buspar C Date:03/12/98ISR Number: 3146649-8Report Type:Periodic Company Report #JAUSA-27500 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone) PS Janssen ORAL TABLET, 8 MG DAILY ORAL Date:03/12/98ISR Number: 3146653-XReport Type:Periodic Company Report #JAUSA-27541 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Muscle Contractions Professional (Risperidone) PS Janssen ORAL SEE IMAGE Involuntary Haldol (Haloperidol) SS Janssen ORAL 1 MG 2 DAILY ORAL Zyprexa (Olanzapine) SS ORAL SEE IMAGE 9 WK Prozac (Fluoxetine) C Depakote C Eskalith C Atenolol C Date:03/12/98ISR Number: 3146657-7Report Type:Periodic Company Report #JAUSA-27544 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Risperdal Professional (Risperidone) PS Janssen ORAL .5 MG 2 DAILY ORAL Coumadin C Date:03/12/98ISR Number: 3146662-0Report Type:Periodic Company Report #JAUSA-27545 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrasystoles Health Risperdal Ventricular Tachycardia Professional (Risperidone) PS Janssen ORAL .5 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3146666-8Report Type:Periodic Company Report #JAUSA-27547 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Prolonged Health Risperdal Initial or Prolonged Sedation Professional (Risperidone) PS Janssen ORAL SINGLE ORAL, Tachycardia CHILD INGESTED 4 TO 22-Feb-2006 08:20 AM Page: 220 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 5 TABLETS. Date:03/12/98ISR Number: 3146671-1Report Type:Periodic Company Report #JAUSA-27594 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Risperdal Initial or Prolonged Increased Professional (Risperidone) PS Janssen ORAL 4-6 MG DAILY Blood Lactate ORAL Dehydrogenase Increased Artane C Cholelithiasis Ativan C Hyperbilirubinaemia Jaundice Date:03/12/98ISR Number: 3146675-9Report Type:Periodic Company Report #JAUSA-27634 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Risperdal Initial or Prolonged Grand Mal Convulsion Health (Risperidone) PS Janssen ORAL 4 MG DAILY Tachycardia Professional ORAL Folate C Date:03/12/98ISR Number: 3146678-4Report Type:Periodic Company Report #JAUSA-27641 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Study Risperdal Initial or Prolonged Health (Risperidone) PS Janssen ORAL 2 MG 2 DAILY Professional ORAL Tofranil C Zoloft C Klonopin C Depakote C Hytrin C Axid C Date:03/12/98ISR Number: 3146681-4Report Type:Periodic Company Report #JAUSA-27658 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3146685-1Report Type:Periodic Company Report #JAUSA-27660 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL SEEN IMAGE Albuterol C Theophylline C Salmeterol C Magnesium Oxide C Diazepam C Beclomethasone C 22-Feb-2006 08:20 AM Page: 221 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3146689-9Report Type:Periodic Company Report #JAUSA-27663 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Consumer Risperdal (Risperidone) PS Janssen ORAL 2 MG 2 DAILY ORAL Digoxin C Lasix C Isordil C Date:03/12/98ISR Number: 3146691-7Report Type:Periodic Company Report #JAUSA-27664 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL Prolixin-Decanoate C Artane C Zoloft C Prolixin C Date:03/12/98ISR Number: 3146693-0Report Type:Periodic Company Report #JAUSA-27665 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Schizoaffective Disorder Health Risperdal Professional (Risperidone) PS Janssen ORAL 2 DAILY ORAL Cogentin C Glyburide C Date:03/12/98ISR Number: 3146695-4Report Type:Periodic Company Report #JAUSA-27666 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3146697-8Report Type:Periodic Company Report #JAUSA-27671 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 1MG 2 DAILY ORAL Prozac C Date:03/12/98ISR Number: 3146700-5Report Type:Periodic Company Report #JAUSA-27674 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Paxil C 22-Feb-2006 08:20 AM Page: 222 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unspecified C Date:03/12/98ISR Number: 3146703-0Report Type:Periodic Company Report #JAUSA-27676 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3146858-8Report Type:Periodic Company Report #JAUSA-30315 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Consumer Risperdal Libido Decreased (Risperidone) PS Janssen ORAL 4 MG 2 DAILY Weight Increased ORAL Depakote (Valproate Sodium) C Tetracycline (Tetracycline) C Date:03/12/98ISR Number: 3146862-XReport Type:Periodic Company Report #JAUSA-30317 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3146864-3Report Type:Periodic Company Report #JAUSA-30318 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertriglyceridaemia Consumer Risperdal Increased Appetite (Risperidone) PS Janssen ORAL 2 MG ORAL Thirst Paxil C Weight Increased Date:03/12/98ISR Number: 3146866-7Report Type:Periodic Company Report #JAUSA-30320 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Risperdal Initial or Prolonged Nightmare (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL 5 DAY Date:03/12/98ISR Number: 3146869-2Report Type:Periodic Company Report #JAUSA-30322 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal (Risperidone) PS Janssen ORAL 4 MG DAILY ORAL Depakote C 22-Feb-2006 08:20 AM Page: 223 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Propantheline (Propantheline) C Ativan (Lorezepam) C Date:03/12/98ISR Number: 3146871-0Report Type:Periodic Company Report #JAUSA-30325 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acne Consumer Risperdal Alopecia (Risperidone) PS Janssen ORAL 1 MG 2 DAILY Libido Decreased ORAL Date:03/12/98ISR Number: 3146873-4Report Type:Periodic Company Report #JAUSA-30329 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertrophy Breast Consumer Risperdal (Risperidone) PS Janssen ORAL 0.5 MG 2 DAILY ORAL Luvox C Date:03/12/98ISR Number: 3146875-8Report Type:Periodic Company Report #JAUSA-30358 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Prozac C Trazodone C Anafranil C Remeron C Date:03/12/98ISR Number: 3146878-3Report Type:Periodic Company Report #JAUSA-30359 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3146880-1Report Type:Periodic Company Report #JAUSA-30361 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Risperdal Depersonalisation (Risperidone) PS Janssen ORAL 1 MG 2 DAILY Dizziness ORAL Headache Artane Muscle Spasms (Trihexyphenidryl) C Pain Thinking Abnormal 22-Feb-2006 08:20 AM Page: 224 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3146884-9Report Type:Periodic Company Report #JAUSA-30364 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3146886-2Report Type:Periodic Company Report #JAUSA-30365 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Risperdal Initial or Prolonged Agitation (Risperidone) PS Janssen ORAL 6 MG DAILY Mood Swings ORAL Paranoia Repetitive Speech Date:03/12/98ISR Number: 3146887-4Report Type:Periodic Company Report #JAUSA-30366 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Consumer Risperdal Paranoia (Risperidone) PS Janssen ORAL 2 MG 2 DAILY ORAL Prilosec C Entex C Insulin C Diabeta C Date:03/12/98ISR Number: 3146888-6Report Type:Periodic Company Report #JAUSA-30369 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Withdrawal Arrhythmia Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3146889-8Report Type:Periodic Company Report #JAUSA-30370 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Consumer Risperdal Dyspnoea (Risperidone) PS Janssen ORAL 1 MG 2 DAILY Fatigue ORAL Tachycardia Catapres C Weight Increased Luvox C Prozac C Date:03/12/98ISR Number: 3146890-4Report Type:Periodic Company Report #JAUSA-30373 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Palpitations Consumer Risperdal (Risperidone) PS Janssen ORAL 2 MG DAILY ORAL Norvasc C Captopril C Premarin C 22-Feb-2006 08:20 AM Page: 225 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Albuterol C Atrovent C Klonopin C Benztropine C Date:03/12/98ISR Number: 3146891-6Report Type:Periodic Company Report #JAUSA-30375 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Attention Professional (Risperidone) PS Janssen ORAL 4 MG 2 DAILY Deficit/Hyperactivity ORAL Disorder Cogentin C Nicoderm C Motrin C Date:03/12/98ISR Number: 3146892-8Report Type:Periodic Company Report #JAUSA-30376 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Consumer Risperdal (Risperidone) PS Janssen ORAL 2 MG DAILY ORAL Prednisone C Antibiot. Unspec C Date:03/12/98ISR Number: 3146893-XReport Type:Periodic Company Report #JAUSA-30378 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Pain Consumer Risperdal Gynaecomastia (Risperidone) PS Janssen ORAL 1 MG 2 DAILY Hyperprolactinaemia ORAL Imodium (Loperamide) C Imuran (Azathioprine) C Lithium (Lithium) C Date:03/12/98ISR Number: 3146894-1Report Type:Periodic Company Report #JAUSA-30389 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Inderal (Propranolol) SS Date:03/12/98ISR Number: 3147973-5Report Type:Periodic Company Report #JAUSA-30499 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Tongue Paralysis Professional (Risperidone), Tremor Janssen PS Janssen 5 DAY Clonpin (Clonazepam) C Prevacid 22-Feb-2006 08:20 AM Page: 226 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Lansprazole) C Date:03/12/98ISR Number: 3147975-9Report Type:Periodic Company Report #JAUSA-30500 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3147977-2Report Type:Periodic Company Report #JAUSA-30501 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone),Jansse n, Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3147978-4Report Type:Periodic Company Report #JAUSA-30503 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Risperdal (Risperidone), Janssen, Tablet PS Janssen ORAL 8 MG DAILY ORAL Paxil (Paroxetine) C Date:03/12/98ISR Number: 3147979-6Report Type:Periodic Company Report #JAUSA-30504 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 3 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3147981-4Report Type:Periodic Company Report #JAUSA-30505 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Consumer Risperdal (Risperidone), Janssen, Tablet PS Janssen ORAL .5 MG 4 DAILY ORAL Ativan (Lorazepam) C Date:03/12/98ISR Number: 3147983-8Report Type:Periodic Company Report #JAUSA-30510 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Pain Consumer Risperdal Diarrhoea (Risperidone), Pain In Extremity Janssen, Tablet PS Janssen ORAL .5 MG DAILY ORAL Depakote (Valproate 22-Feb-2006 08:20 AM Page: 227 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Lasix (Furosemide) C Monopril (Fosinopril) C Mortin (Ibuprofen) C Vitamin B-1 (Thiamine) C Date:03/12/98ISR Number: 3147984-XReport Type:Periodic Company Report #JAUSA-30194 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3147985-1Report Type:Periodic Company Report #JAUSA-30498 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal Vomiting Professional (Risperidone), Janssen, Tablet PS ORAL 2 MG DAILY ORAL Prilosec (Omerpazole) C Date:03/12/98ISR Number: 3148262-5Report Type:Periodic Company Report #JAUSA-29677 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blepharospasm Risperdal (Risperidone) Janssen Tablet PS Janssen ORAL 6MG DAILY ORAL Haldol C Lithobid C Deconanoid C Date:03/12/98ISR Number: 3148263-7Report Type:Periodic Company Report #JAUSA-29678 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal Professional (Risperidone) Janssen Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3148265-0Report Type:Periodic Company Report #JAUSA-29679 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tremor Risperdal (Risperidone) Janssen Tablet PS Janssen ORAL ORAL Wellbutrin (Amfebutamone) SS Depakote SS 22-Feb-2006 08:20 AM Page: 228 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3148267-4Report Type:Periodic Company Report #JAUSA-29695 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Health Risperdal Professional (Risperidone) Janssen Tablet PS Janssen ORAL 6MG 1 DAILY ORAL Prozac C Date:03/12/98ISR Number: 3148269-8Report Type:Periodic Company Report #JAUSA-29704 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Crying Health Risperdal Drug Effect Increased Professional (Risperidone) Personality Disorder Janssen Tablet 2mg PS Janssen ORAL 12MG SINGLE Sedation DOSE ORAL; 6 Tachycardia TABLETS INGESTED Date:03/12/98ISR Number: 3148273-XReport Type:Periodic Company Report #JAUSA-29707 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Above Health Risperdal Therapeutic Professional (Risperidone) Sedation Janssen Tablet PS Janssen ORAL 8MG 2 DAILY ORAL Haldol C Haldol-Decanoas C Effexor C Prozac C Depakene C Klonopin C Date:03/12/98ISR Number: 3148274-1Report Type:Periodic Company Report #JAUSA-29711 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Risperdal Abnormal (Risperidone) Janssen Tablet PS Janssen ORAL 12MG DAILY ORAL, 8MG IN AM 4 MG H.S. Date:03/12/98ISR Number: 3148277-7Report Type:Periodic Company Report #JAUSA-29712 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Risperdal Abnormal Professional (Risperidone) Janssen Tablet 1mg PS Janssen ORAL 1MG 2 DAILY ORAL 22-Feb-2006 08:20 AM Page: 229 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3148283-2Report Type:Periodic Company Report #JAUSA-29713 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal Condition Aggravated (Risperidone) Insomnia Janssen Tablet 3mg PS Janssen ORAL 3MG 2 DAILY Sedation ORAL; 8MG Eskalith C Xanax C Ambien C Tenoretic C Calan C Benadryl C Nyquil C Date:03/12/98ISR Number: 3148286-8Report Type:Periodic Company Report #JAUSA-29714 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Risperdal Weight Increased Professional (Risperidone) Janssen Tablet PS Janssen ORAL 3MG DAILY ORAL Methadone C Date:03/12/98ISR Number: 3148289-3Report Type:Periodic Company Report #JAUSA-29715 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Consumer Risperdal Anxiety (Risperidone) Headache Janssen Tablet PS Janssen ORAL 1.5MG DAILY Hypersensitivity ORAL Zoloft (Sertraline) SS ORAL ORAL Atneolol (Atenolol) SS ORAL 0.5 IN AM, 1.0 IN PM Trazodone (Trazodone) SS ORAL ORAL Zantac (Ranitidine) SS ORAL ORAL Date:03/12/98ISR Number: 3148293-5Report Type:Periodic Company Report #JAUSA-29718 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Obsessive-Compulsive (Risperidone) Disorder Janssen Tablet PS Janssen ORAL 3MG 2 DAILY ORAL, 2MG 2 DAILY ORAL Anafranil C Stelazine C Olanzapine C 22-Feb-2006 08:20 AM Page: 230 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3148295-9Report Type:Periodic Company Report #JAUSA-29732 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Prothrombin Level Risperdal Increased (Risperidone) Janssen Tablets PS Janssen ORAL ORAL Coumadin SS Date:03/12/98ISR Number: 3148297-2Report Type:Periodic Company Report #JAUSA-29736 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Risperdal ( Risperidone) Janssen Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3148299-6Report Type:Periodic Company Report #JAUSA-29737 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Consumer Risperdal Gynaecomastia (Risperidone) Hyperprolactinaemia Janssen Tablet PS Janssen ORAL 6MG DAILY ORAL, 7MG DAILY Motrin C Tylenol C Amantadine C Hydrocortisone-Cream C Date:03/12/98ISR Number: 3148304-7Report Type:Periodic Company Report #JAUSA-29749 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Chest Pain (Risperidone) Tachycardia Janssen Tablets PS Janssen ORAL 3MG 2 DAILY ORAL, AN OCASSINAL 1MG IS ADDED DAILY WHEN Wellbutrin (Amfebutamone) SS ORAL 75MG 2 DAILY ORAL,75MG 3 DAILY 6 DAY Claritin-D C Date:03/12/98ISR Number: 3148307-2Report Type:Periodic Company Report #JAUSA-29751 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neurosis Consumer Risperdal (Risperidone) Janssen Tablet PS Janssen ORAL .5MG 1 DAILY ORAL 22-Feb-2006 08:20 AM Page: 231 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3148308-4Report Type:Periodic Company Report #JAUSA-29752 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone) Janssen Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3148370-9Report Type:Periodic Company Report #JAUSA-29748 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Consumer Risperdal (Risperidone) Janssen Tablet PS Janssen ORAL 2MG 2 DAILY ORAL Xanax C Date:03/12/98ISR Number: 3148649-0Report Type:Periodic Company Report #JAUSA-27700 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone),Jansse n, Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3148650-7Report Type:Periodic Company Report #JAUSA-27705 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG DAILY ORAL; 3MG DAILY 27 DAY Paxil C Cogentin C Valproic Acid C Clozaril C Prolixin D C Date:03/12/98ISR Number: 3148651-9Report Type:Periodic Company Report #JAUSA-27706 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Consumer Risperdal Dry Skin (Risperidone), Flushing Janssen, Tablet PS Janssen ORAL .5 MG 1 DAILY Hyperhidrosis ORAL Insomnia Xanax C Myalgia Palpitations Tachycardia Urine Abnormality 22-Feb-2006 08:20 AM Page: 232 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3148652-0Report Type:Periodic Company Report #JAUSA-28373 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Risperdal Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 2.5 MG DAILY ORAL (1.5 MG IN AM/1 MG IN PM) Thorazine C Lithium C Date:03/12/98ISR Number: 3148653-2Report Type:Periodic Company Report #JAUSA-28375 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Parkinsonism Professional (Risperidone), Janssen, Tablet PS Janssen ORAL DAILY, ORAL Sinemet (Sinemet (R)) SS Date:03/12/98ISR Number: 3148654-4Report Type:Periodic Company Report #JAUSA-28377 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Hyperprolactinaemia (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3148655-6Report Type:Periodic Company Report #JAUSA-28387 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pain Health Risperdal Initial or Prolonged Thrombophlebitis Pelvic Professional (Risperidone), Vein Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG DAILY Vena Cava Thrombosis ORAL AT BEDTIME Date:03/12/98ISR Number: 3148656-8Report Type:Periodic Company Report #JAUSA-28392 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Health Risperdal Initial or Prolonged Injury Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 4 MG 2 DAILY ORAL; 3MG 2 DAILY Valproic Acid C Prozac C Lasix C 22-Feb-2006 08:20 AM Page: 233 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3148657-XReport Type:Periodic Company Report #JAUSA-28393 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cough Consumer Risperdal (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG DAILY ORAL, WEANING TO 0.25MG/DAY Wellbutrin C Date:03/12/98ISR Number: 3148658-1Report Type:Periodic Company Report #JAUSA-28394 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Consumer Risperdal Sedation (Risperidone) PS Janssen ORAL 2 MG 2 DAILY Syncope ORAL;3 MG 3 DAILY ORAL 2 YR Prozac C Date:03/12/98ISR Number: 3148659-3Report Type:Periodic Company Report #JAUSA-28395 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Health Risperdal Condition Aggravated Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG 1 DAILY ORAL Date:03/12/98ISR Number: 3148660-XReport Type:Periodic Company Report #JAUSA-28396 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone), Janssen, Tablet PS Janssen ORAL 1.5 MG 1 DAILY ORAL Date:03/12/98ISR Number: 3148661-1Report Type:Periodic Company Report #JAUSA-28397 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Consumer Risperdal Weight Increased (Risperidone), Janssen, Tablet PS Janssen ORAL .5 MG 1 DAILY ORAL 10 MON Date:03/12/98ISR Number: 3148662-3Report Type:Periodic Company Report #JAUSA-28398 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Tardive Dyskinesia (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG 1 DAILY ORAL; 1MG 2 DAILY; .5MG 1 22-Feb-2006 08:20 AM Page: 234 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAILY 3 YR Risperdal (Risperidone) SS ORAL 1 MG 2 DAILY ORAL TABLET Risperdal (Risperidone) SS ORAL .5 MG 1 DAILY ORAL TABLET Date:03/12/98ISR Number: 3148663-5Report Type:Periodic Company Report #JAUSA-28400 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 4 MG 1 DAILY ORAL; 1MG 1 DAILY Date:03/12/98ISR Number: 3148664-7Report Type:Periodic Company Report #JAUSA-28402 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL .5 MG 2 DAILY ORAL . C Paxil C Trazodone C Date:03/12/98ISR Number: 3149395-XReport Type:Periodic Company Report #JAUSA-30213 (E) Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Professional ORAL Paxil C Cogentin C Date:03/12/98ISR Number: 3149398-5Report Type:Periodic Company Report #JAUSA-30214 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Consumer Risperdal PS Janssen ORAL 3MG 3 DAILY ORAL Depakote SS ORAL 250MG 4 DAILY ORAL Date:03/12/98ISR Number: 3149400-0Report Type:Periodic Company Report #JAUSA-30216 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Consumer Risperdal PS ORAL -, ORAL 22-Feb-2006 08:20 AM Page: 235 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3149402-4Report Type:Periodic Company Report #JAUSA-30217 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertrophy Breast Consumer Risperdal PS Janssen ORAL 1.5MG DAILY ORAL Date:03/12/98ISR Number: 3149404-8Report Type:Periodic Company Report #JAUSA-30219 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paranoia Health Risperdal PS ORAL -, ORAL Professional Date:03/12/98ISR Number: 3149405-XReport Type:Periodic Company Report #JAUSA-30222 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal PS Janssen ORAL -, ORAL Professional Date:03/12/98ISR Number: 3149407-3Report Type:Periodic Company Report #JAUSA-30223 Age:13 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Health Risperdal PS Janssen ORAL -, DAILY Infection Professional ORAL; UP TO 9 MG DAILY Anafranil C Date:03/12/98ISR Number: 3149408-5Report Type:Periodic Company Report #JAUSA-30226 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal PS Janssen ORAL 4MG DAILY Professional ORAL Paxil C Date:03/12/98ISR Number: 3149410-3Report Type:Periodic Company Report #JAUSA-30227 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Flushing Consumer Risperdal PS Janssen ORAL 4 MG DAILY Hypertension ORAL Tinnitus Risperdal SS ORAL 8MG DAILY Weight Increased ORAL TABLET Klonopin C Zoloft C Artame C Prevacid C Theo-Dur C Accolate C Beclovent C Atrovent C Proventil C Serevent C Mysoline C 22-Feb-2006 08:20 AM Page: 236 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3149411-5Report Type:Periodic Company Report #JAUSA-30232 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal PS Janssen ORAL 4MG 2 DAILY Attention Professional ORAL Deficit/Hyperactivity Nicoderm C Disorder Cogentin C Motrin C Date:03/12/98ISR Number: 3149413-9Report Type:Periodic Company Report #JAUSA-30234 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thirst Health Risperdal PS Janssen ORAL -, ORAL Urinary Incontinence Professional Date:03/12/98ISR Number: 3149414-0Report Type:Periodic Company Report #JAUSA-30237 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal PS ORAL -, ORAL Professional Date:03/12/98ISR Number: 3149415-2Report Type:Periodic Company Report #JAUSA-30257 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperdal PS ORAL 2 MG DAILY ORAL TABLET/1 MG DAIL ORAL TABLET 4 WK Risperdal SS ORAL 1 MG DAILY ORAL TABLET 4 WK Date:03/12/98ISR Number: 3149416-4Report Type:Periodic Company Report #JAUSA-30284 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL 2 MG 2 DAILY Hyperprolactinaemia Professional ORAL 2 YR Pituitary Tumour Risperdal SS ORAL 2MG 1 DAILY ORAL TABLET Lithium C Date:03/12/98ISR Number: 3149417-6Report Type:Periodic Company Report #JAUSA-30287 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sleep Disorder Health Risperdal PS Janssen ORAL 4 MG DAILY Thinking Abnormal Professional ORAL 22-Feb-2006 08:20 AM Page: 237 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3149418-8Report Type:Periodic Company Report #JAUSA-30289 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal PS Janssen ORAL -, ORAL Initial or Prolonged Syndrome Professional Date:03/12/98ISR Number: 3149419-XReport Type:Periodic Company Report #JAUSA-30291 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Consumer Risperdal PS Janssen ORAL -, ORAL Haldol SS Janssen Date:03/12/98ISR Number: 3149420-6Report Type:Periodic Company Report #JAUSA-30293 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Risperdal PS Janssen ORAL -, ORAL Professional Date:03/12/98ISR Number: 3149421-8Report Type:Periodic Company Report #JAUSA-30295 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL -, ORAL Professional Date:03/12/98ISR Number: 3149423-1Report Type:Periodic Company Report #JAUSA-30297 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Faecal Incontinence Health Risperdal PS Janssen ORAL .25 MG 1 Urinary Incontinence Professional DAILY ORAL/.25 MG 2 DAILY ORAL/.25 MG 3 7 DAY .. C ... C Date:03/12/98ISR Number: 3149637-0Report Type:Periodic Company Report #JAUSA-27359 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Risperdal PS ORAL ORAL Professional Date:03/12/98ISR Number: 3149640-0Report Type:Periodic Company Report #JAUSA-27360 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Consumer Risperdal PS ORAL ORAL Libido Increased Clonidine C Muscle Contractions Lescol C Involuntary Benadryl C Pollakiuria 22-Feb-2006 08:20 AM Page: 238 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3149642-4Report Type:Periodic Company Report #JAUSA-27361 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL 3 MG 1 DAY Galactorrhoea Professional ORAL;6MG 1 Hyperprolactinaemia DAILY ... C Date:03/12/98ISR Number: 3149654-0Report Type:Periodic Company Report #JAUSA-29974 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Consumer Risperdal PS Janssen ORAL 1.5 MG DAILY Gastritis ORAL- 0.5 MG IN AM, 1 MG IN PM. Date:03/12/98ISR Number: 3149655-2Report Type:Periodic Company Report #JAUSA-29979 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscular Weakness Consumer Risperdal PS Janssen ORAL 2 MG 2 DAILY ORAL-3 MG 3 DAILY ORAL- 3 MG 4 DAILY ORAL Depakote C Date:03/12/98ISR Number: 3149656-4Report Type:Periodic Company Report #JAUSA-29981 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Consumer Risperdal PS Janssen ORAL ORAL Date:03/12/98ISR Number: 3149659-XReport Type:Periodic Company Report #JAUSA-29982 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hearing Impaired Health Risperdal PS Janssen ORAL 2 DAILY ORAL- Professional UP TO 1 MG TWO TIMES DAILY Date:03/12/98ISR Number: 3149660-6Report Type:Periodic Company Report #JAUSA-30012 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Risperdal PS Janssen ORAL 4 MG 2 DAILY Agitation ORAL- 3 MG 2 DAILY ORAL Lithium C Depakote C Xanax C 22-Feb-2006 08:20 AM Page: 239 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3149661-8Report Type:Periodic Company Report #JAUSA-30082 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrolyte Imbalance Consumer Risperdal PS Janssen ORAL 6 MG DAILY Initial or Prolonged Hyperhidrosis ORAL- 1.5 MG Hyponatraemia DAILY ORAL Zyprexa C Tegretal C Depakote C Micronase C Prinivil C Hydrochlorothiazide C Date:03/12/98ISR Number: 3149663-1Report Type:Periodic Company Report #JAUSA-30104 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal PS Janssen ORAL 1 MG 1 DAILY Extrapyramidal Disorder ORAL Procardia C Chlorothiazide C Aspirin C Date:03/12/98ISR Number: 3149664-3Report Type:Periodic Company Report #JAUSA-30112 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen ORAL 3 MG 1 DAILY Initial or Prolonged Hyponatraemia ORAL Visual Disturbance Tegretol C Depakote C Date:03/12/98ISR Number: 3149666-7Report Type:Periodic Company Report #JAUSA-30117 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Consumer Risperdal PS Janssen ORAL .5 MG ORAL Klonopin SS ORAL ORAL Desyrel C Date:03/12/98ISR Number: 3149667-9Report Type:Periodic Company Report #JAUSA-30120 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bruxism Health Risperdal PS Janssen ORAL 5 MG ORAL- 2 Ejaculation Disorder Professional MG IN AM, 3 MG IN PM Depakote C Date:03/12/98ISR Number: 3149669-2Report Type:Periodic Company Report #JAUSA-30123 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Health Risperdal PS Janssen ORAL 3 MG DAILY Thirst Professional ORAL 22-Feb-2006 08:20 AM Page: 240 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3149670-9Report Type:Periodic Company Report #JAUSA-30126 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen Professional Date:03/12/98ISR Number: 3149672-2Report Type:Periodic Company Report #JAUSA-30158 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gamma-Glutamyltransferase Health Risperdal PS Janssen ORAL 16 MG DAILY Increased Professional ORAL Haldol C Lithium C Date:03/12/98ISR Number: 3149673-4Report Type:Periodic Company Report #JAUSA-30160 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Consumer Risperdal PS Janssen ORAL 2 DAILY ORAL- Deficit/Hyperactivity 2 MG 2 DAILY Disorder ORAL-0.5-1 MG DAILY Paxil C Zyprexa C Pindolol C Date:03/12/98ISR Number: 3149674-6Report Type:Periodic Company Report #JAUSA-30161 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal PS Janssen ORAL ORAL Professional Lamictal C Date:03/12/98ISR Number: 3149676-XReport Type:Periodic Company Report #JAUSA-30162 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Risperdal PS Janssen ORAL 2 MG 2 DAILY Drug Interaction ORAL Tegretol SS ORAL 700 MG 3 DAILY ORAL- 300 MG IN AM, 400 MG IN PM Date:03/12/98ISR Number: 3149677-1Report Type:Periodic Company Report #JAUSA-30167 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal PS Janssen ORAL 2 MG 2 DAILY Initial or Prolonged Hyponatraemia Professional ORAL- 1 MG 2 DAILY ORAL Paxil C 22-Feb-2006 08:20 AM Page: 241 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3149679-5Report Type:Periodic Company Report #JAUSA-30177 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epistaxis Health Risperdal PS Janssen ORAL .5 MG 1 DAILY Thrombocytopenia Professional ORAL Zoloft C Asa C Pericolace C Dulcolax C Tylenol C Citrucal C Date:03/12/98ISR Number: 3149680-1Report Type:Periodic Company Report #JAUSA-27362 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Health Risperdal PS Janssen ORAL .5 MG DAILY Professional ORAL Prozac C Date:03/12/98ISR Number: 3149681-3Report Type:Periodic Company Report #JAUSA-30189 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal PS Janssen ORAL 1 MG DAILY Headache ORAL Zoloft C Verapamil C Date:03/12/98ISR Number: 3149683-7Report Type:Periodic Company Report #JAUSA-30192 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal PS Janssen ORAL 4 MG DAILY ORAL Ativan C Wellbutrin C Date:03/12/98ISR Number: 3149684-9Report Type:Periodic Company Report #JAUSA-27363 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Health Risperdal PS Janssen ORAL 8 MG DAILY Professional ORAL Tegretol C Depakote C Cogentin C Tegretol C Date:03/12/98ISR Number: 3149686-2Report Type:Periodic Company Report #JAUSA-27365 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Consumer Risperdal PS ORAL ORAL Initial or Prolonged Anafranil C Niferex C 22-Feb-2006 08:20 AM Page: 242 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Peridex C Iron C Date:03/12/98ISR Number: 3149688-6Report Type:Periodic Company Report #JAUSA-27366 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3149689-8Report Type:Periodic Company Report #JAUSA-27272 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vertigo Health Risperdal PS Janssen ORAL 1 MG DAILY Professional ORAL-2 MG DAILY ORAL- 2.5 MG DAILY ORAL 9 DAY Date:03/12/98ISR Number: 3149690-4Report Type:Periodic Company Report #JAUSA-27273 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Professional ORAL-1 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3149692-8Report Type:Periodic Company Report #JAUSA-27274 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Flushing Health Risperdal PS Janssen ORAL 2.5 MG DAILY Professional ORAL- 2 MG DAILY ORAL Date:03/12/98ISR Number: 3149693-XReport Type:Periodic Company Report #JAUSA-27294 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal PS Janssen ORAL 1 MG 1 DAILY Professional ORAL- 2 MG 2 DAILY ORAL Imipramine C Date:03/12/98ISR Number: 3149694-1Report Type:Periodic Company Report #JAUSA-27368 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Risperdal PS Janssen ORAL 6 MG DAILY Professional ORAL 22-Feb-2006 08:20 AM Page: 243 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3149695-3Report Type:Periodic Company Report #JAUSA-27295 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal PS Janssen ORAL 2 MG DAILY ORAL Date:03/12/98ISR Number: 3149696-5Report Type:Periodic Company Report #JAUSA-27370 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pyrexia Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Professional ORAL;8 MG DAILY ORAL 3 DAY ... C Date:03/12/98ISR Number: 3149697-7Report Type:Periodic Company Report #JAUSA-27301 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Torticollis Health Risperdal PS Janssen ORAL 1.5 MG DAILY Professional ORAL Depakote C Estrogens Conjugated C Date:03/12/98ISR Number: 3149698-9Report Type:Periodic Company Report #JAUSA-27371 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Risperdal PS Janssen ORAL ORAL Increased Professional Aspartate Aminotransferase Increased Date:03/12/98ISR Number: 3149699-0Report Type:Periodic Company Report #JAUSA-27302 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Risperdal PS Janssen ORAL 1.5 MG DAILY Initial or Prolonged Condition Aggravated ORAL Headache Estrafon C Hypertonia Thorazine C Muscle Contractions Involuntary Date:03/12/98ISR Number: 3149700-4Report Type:Periodic Company Report #JAUSA-27375 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL ORAL Professional Tenex C Tegretol C 22-Feb-2006 08:20 AM Page: 244 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3149702-8Report Type:Periodic Company Report #JAUSA-27303 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal PS Janssen ORAL 1 MG 2 DAILY Paraesthesia ORAL- 1 MG DAILY ORAL Date:03/12/98ISR Number: 3149703-XReport Type:Periodic Company Report #JAUSA-27376 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal PS Janssen ORAL ORAL Torticollis Professional Wellbutrin C Date:03/12/98ISR Number: 3149704-1Report Type:Periodic Company Report #JAUSA-27305 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS Janssen ORAL 3 MG DAILY Galactorrhoea ORAL Thyroid Disorder Lithium C Depakote C Date:03/12/98ISR Number: 3149705-3Report Type:Periodic Company Report #JAUSA-27377 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal PS Janssen ORAL DAILY ORAL Professional Date:03/12/98ISR Number: 3149707-7Report Type:Periodic Company Report #JAUSA-27306 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL ORAL Galactorrhoea Professional Hyperprolactinaemia Date:03/12/98ISR Number: 3149708-9Report Type:Periodic Company Report #JAUSA-27380 Age:16 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3149710-7Report Type:Periodic Company Report #JAUSA-27308 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Consumer Risperdal PS Janssen ORAL ORAL Gait Disturbance 22-Feb-2006 08:20 AM Page: 245 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3149711-9Report Type:Periodic Company Report #JAUSA-27381 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL ORAL Professional Date:03/12/98ISR Number: 3149712-0Report Type:Periodic Company Report #JAUSA-27309 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Consumer Risperdal PS Janssen ORAL 4 MG DAILY ORAL Zoloft SS ORAL 50 MG DAILY ORAL Date:03/12/98ISR Number: 3149714-4Report Type:Periodic Company Report #JAUSA-27393 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL 2 DAILY ORAL Hyperprolactinaemia Professional Amitriptyline C Date:03/12/98ISR Number: 3149715-6Report Type:Periodic Company Report #JAUSA-27311(W) Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothyroidism Consumer Risperdal PS Janssen ORAL .5 MG 2 DAILY Weight Increased ORAL Date:03/12/98ISR Number: 3149716-8Report Type:Periodic Company Report #JAUSA-27394 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS ORAL 1 MG 2 DAILY Hyperprolactinaemia Professional ORAL;.5MG 2 DAILY ORAL Paxil C ... C Date:03/12/98ISR Number: 3149718-1Report Type:Periodic Company Report #JAUSA-27312 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal PS Janssen ORAL 4 MG ORAL- 4 MG ORAL Cogentin C Date:03/12/98ISR Number: 3149719-3Report Type:Periodic Company Report #JAUSA-27395 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal PS Janssen ORAL 6 MG 1 DAILY Neutropenia Professional ORAL Depakote C 22-Feb-2006 08:20 AM Page: 246 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3149721-1Report Type:Periodic Company Report #JAUSA-27396 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Risperdal PS Janssen ORAL 6 MG 1 DAILY Professional ORAL Buspar C ... C Date:03/12/98ISR Number: 3149722-3Report Type:Periodic Company Report #JAUSA-27313 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Consumer Risperdal PS Janssen ORAL 3 MG DAILY ORAL- 6 MG DAILY ORAL Cogentin C Date:03/12/98ISR Number: 3149723-5Report Type:Periodic Company Report #JAUSA-27316 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Health Risperdal PS Janssen ORAL 3 MG DAILY Professional ORAL- AT BEDTIME Date:03/12/98ISR Number: 3149724-7Report Type:Periodic Company Report #JAUSA-27397 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Risperdal PS Janssen ORAL 2.5 MG 1 Professional DAILY ORAL Paxil C Lithium C Mevacor C Klonopin C Date:03/12/98ISR Number: 3149725-9Report Type:Periodic Company Report #JAUSA-27317 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Risperdal PS Janssen . 5 MG 1 Speech Disorder Professional DAILY Visual Disturbance Relafen C Prozac C Xanax C Date:03/12/98ISR Number: 3149726-0Report Type:Periodic Company Report #JAUSA-27320 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Consumer Risperdal PS Janssen ORAL 3 MG DAILY Haematuria ORAL- 6 MG Perineal Pain DAILY 22-Feb-2006 08:20 AM Page: 247 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3149728-4Report Type:Periodic Company Report #JAUSA-27322 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Risperdal PS Janssen ORAL ORAL Professional Unspecified C Date:03/12/98ISR Number: 3149730-2Report Type:Periodic Company Report #JAUSA-27344 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Disorder Study Risperdal PS Janssen ORAL 6 MG DAILY Initial or Prolonged Endocarditis Health ORAL Gait Disturbance Professional Chlopromazine C Headache Glyburide C Hyperglycaemia Leukocytosis Nausea Vomiting Date:03/12/98ISR Number: 3149862-9Report Type:Periodic Company Report #JAUSA-30465 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal PS Janssen ORAL 2 -6 MG , Professional DAILY, PO Date:03/12/98ISR Number: 3149865-4Report Type:Periodic Company Report #JAUSA-30468 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Health Risperdal PS Janssen ORAL 1.5 MG DAILY Liver Function Test Professional ORAL Abnormal Date:03/12/98ISR Number: 3149870-8Report Type:Periodic Company Report #JAUSA-30469 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Risperdal PS Janssen ORAL 1.5 MG/ 3 MG Apathy DAILY ORAL Insomnia SEE IMAGE Libido Decreased Date:03/12/98ISR Number: 3149873-3Report Type:Periodic Company Report #JAUSA-30470 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal PS Janssen ORAL 10 MG DAILY Myalgia ORAL Procardia C 22-Feb-2006 08:20 AM Page: 248 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3149877-0Report Type:Periodic Company Report #JAUSA-30471 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Risperdal PS Janssen ORAL 4 MG DAILY Professional ORAL Zoloft C Zyprexa C Tegretal C Date:03/12/98ISR Number: 3149881-2Report Type:Periodic Company Report #JAUSA-30472 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nervousness Consumer Risperdal PS Janssen ORAL 1/3 OF A Palpitations TABLET/ / 0. 5 MG 2 DAILY SEE IMAGE, ORAL Ativan C Date:03/12/98ISR Number: 3149899-XReport Type:Periodic Company Report #JAUSA-30476 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Libido Decreased Consumer Risperdal PS ORAL .5 MG DAILY ORAL Lithium C Date:03/12/98ISR Number: 3149902-7Report Type:Periodic Company Report #JAUSA-30478 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal PS Janssen ORAL _, ORAL Drug Interaction Professional Luvox SS ORAL 75 MG 1 DAILY ORAL Date:03/12/98ISR Number: 3149906-4Report Type:Periodic Company Report #JAUSA-30482 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS Janssen ORAL 1 MG /.5 MG Thinking Abnormal ORAL /SEE IMAGE Depakote C Date:03/12/98ISR Number: 3149910-6Report Type:Periodic Company Report #JAUSA-30483 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal PS Janssen ORAL 1.5 MG SINGLE Condition Aggravated ORAL 22-Feb-2006 08:20 AM Page: 249 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3149914-3Report Type:Periodic Company Report #JAUSA-30485 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 1 MG / 2 MG 2 Professional DAILY ORAL SEE IMAGE 11 DAY Hydrochlorothiazide C Triamtere C Clonidine C Date:03/12/98ISR Number: 3149916-7Report Type:Periodic Company Report #JAUSA-30486 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal PS Janssen ORAL 4 MG 2 DAILY ORAL Tetracycline C Depakote C Date:03/12/98ISR Number: 3149917-9Report Type:Periodic Company Report #JAUSA-30487 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Risperdal PS Janssen ORAL 1 MG 2 DAILY ORAL Date:03/12/98ISR Number: 3149918-0Report Type:Periodic Company Report #JAUSA-30488 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal PS Janssen ORAL 2.5 MG DAILY Professional ORAL Lithiun Carbonate C Depakote C Date:03/12/98ISR Number: 3149919-2Report Type:Periodic Company Report #JAUSA-30489 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal PS Janssen ORAL 3 MG 4 DAILY Bone Pain ORAL Osteoarthritis Chlor-Trimeton C Depakote C Benadryl C Date:03/12/98ISR Number: 3149921-0Report Type:Periodic Company Report #JAUSA-30493 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Professional ORAL 22-Feb-2006 08:20 AM Page: 250 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/98ISR Number: 3149922-2Report Type:Periodic Company Report #JAUSA-30494 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal PS Janssen ORAL 2 MG 1 DAILY Professional ORAL Depakote C Date:03/12/98ISR Number: 3149923-4Report Type:Periodic Company Report #JAUSA-30495 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal PS Janssen ORAL 3 MG / 5MG 2 Professional DAILY ORAL / SEE IMAGE Klonopin C Date:03/12/98ISR Number: 3149925-8Report Type:Periodic Company Report #JAUSA-30496 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Risperdal PS Janssen ORAL .5 MG 2 DAILY Sedation ORAL Buspar C Paxil C Date:03/12/98ISR Number: 3149926-XReport Type:Periodic Company Report #JAUSA-30497 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal PS Janssen ORAL _. ORAL Professional Date:03/13/98ISR Number: 3053536-2Report Type:Expedited (15-DaCompany Report #JAUSA-31098 Age:42 YR Gender: I/FU:F Outcome PT Hospitalization - Abdominal Distension Initial or Prolonged Abdominal Pain Acidosis Activated Partial Thromboplastin Time Prolonged Acute Respiratory Distress Syndrome Allergic Granulomatous Angiitis Blood Bicarbonate Decreased Blood Chloride Increased Blood Gases Abnormal Blood Glucose Increased Central Venous Pressure Increased Colitis Ischaemic Constipation Diarrhoea Fibrin D Dimer Increased 22-Feb-2006 08:20 AM Page: 251 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gastroenteritis Clostridial Gastrointestinal Necrosis Report Source Product Role Manufacturer Route Dose Duration Haemorrhage Health Risperdal PS Janseen ORAL 6 MG DAILY Heart Rate Increased Professional ORAL Hypersensitivity Thyrolar C Hypertension Trazodone C Ileus Paralytic Intestinal Infarction Intestinal Ischaemia Liver Function Test Abnormal Metabolic Acidosis Pain Peritoneal Haemorrhage Petechiae Phlebitis Prothrombin Time Prolonged Pulmonary Arterial Wedge Pressure Increased Pyrexia Rash Erythematous Respiratory Rate Increased Rhonchi Sepsis Tachycardia Transfusion Reaction Vaginal Haemorrhage White Blood Cell Count Increased Date:03/13/98ISR Number: 3053540-4Report Type:Expedited (15-DaCompany Report #JABEL-37444 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Risperidal PS Janssen ORAL 3 MG 2 DAILY Logorrhoea Health ORAL 2 WK Psychomotor Hyperactivity Professional Haloperidol C Etumine C Disipal C Valium C Audmentin C Date:03/13/98ISR Number: 3053543-XReport Type:Expedited (15-DaCompany Report #JAFRA-37782 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperidal PS Janssen ORAL 1 MG 1 DAILY Nervous System Disorder Health ORAL Professional Laroxyl C Tercian C Tranxene C Praxilene C Zyloric C Xatral C Torental C Pindione C 22-Feb-2006 08:20 AM Page: 252 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/98ISR Number: 3053547-7Report Type:Expedited (15-DaCompany Report #JAFRA-37447 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Foreign Risperdal PS Janssen ORAL DOSE Bradypnoea Health PROGRESSIVELY Cardiac Arrest Professional INCREASED Cyanosis STARTING FROM Hypothermia 1 MG/DAY, Mental Disorder Risperdal SS ORAL 2 MG 3 DAILY Pyrexia ORAL TO 2 MG 13 WK Respiratory Arrest Tranxene C Korec C Akineton C Duohalac C Nutridoral (-) C Polysilane C Date:03/13/98ISR Number: 3053549-0Report Type:Expedited (15-DaCompany Report #JAFRA-35572 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chorea Foreign Risperdal PS Janssen ORAL 2 MG 1 DAILY Hospitalization - Confusional State Health ORAL, 4 MG 1 Initial or Prolonged Pain In Extremity Professional DAILY ORAL, 2 MG 1 DAILY ORAL 58 DAY Date:03/13/98ISR Number: 3053552-0Report Type:Expedited (15-DaCompany Report #JAUSA-31718 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoxia Health Risperdal PS Janssen ORAL ORAL Initial or Prolonged Professional Date:03/13/98ISR Number: 3053558-1Report Type:Expedited (15-DaCompany Report #JAFRA-37920 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal PS Janssen ORAL 2 MG AND 4MG Initial or Prolonged Platelet Count Decreased Health DAILY ORAL 5 DAY Professional Haldol C Tercian C Date:03/13/98ISR Number: 3053561-1Report Type:Expedited (15-DaCompany Report #JAUK-37279 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatinine Foreign Risperdal PS ORAL 0.5 MG 2 Hospitalization - Increased DAILY ORAL Initial or Prolonged Blood Potassium Increased Thyroxine C Renal Failure Amlopidine C Ismn C Aspirin C 22-Feb-2006 08:20 AM Page: 253 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/98ISR Number: 3066769-6Report Type:Direct Company Report # Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Movement Disorder Risperdal PS 2MG Q HS 1 MON Initial or Prolonged Muscle Twitching Depakote C Neuroleptic Malignant Syndrome Date:03/16/98ISR Number: 3055367-6Report Type:Expedited (15-DaCompany Report #JAFRA-37851 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Foreign Risperdal PS Janssen 1MG 2 DAILY Headache Health ORAL Professional Xanax C Prozac C Stilnox (Zolpidem) C Date:03/20/98ISR Number: 3057117-6Report Type:Expedited (15-DaCompany Report #980316-008010925 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Paralysis Health Haloperidol PS ORAL ORAL Hospitalization - Professional Risperidone SS ORAL ORAL 12 MON Initial or Prolonged Date:03/20/98ISR Number: 3057118-8Report Type:Expedited (15-DaCompany Report #960227-107050555 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Study Haldol PS ORAL 15 MG, QD, Fall Health ORAL Respiratory Disorder Professional Haldol SS INTRAMUSCULAR 200 MG, 1X/MO, IM Depakote SS ORAL 1000 MG, BID, ORAL Risperidone SS ORAL Date:03/20/98ISR Number: 3059772-3Report Type:Expedited (15-DaCompany Report #JACAN-16678 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Paralysis Foreign Risperdal PS Janssen ORAL ORAL 12 MON Hospitalization - Consumer Haldol SS Janssen ORAL ORAL Initial or Prolonged Ativan SS ORAL ORAL Date:03/20/98ISR Number: 3059774-7Report Type:Expedited (15-DaCompany Report #JAUSA-31722 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Consumer Risperdal PS Janssen ORAL .5 MG 2 DAILY Initial or Prolonged Oedema ORAL Oedema Peripheral Aldactone C Rash Pruritic Lasix C Weight Increased 22-Feb-2006 08:20 AM Page: 254 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/98ISR Number: 3059776-0Report Type:Expedited (15-DaCompany Report #JAUSA-31742 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Risperdal PS Janssen ORAL 1 MG 2 DAILY Initial or Prolonged Cough ORAL (1 MG IN Dermatitis Exfoliative A.M., 1 MG IN Dyskinesia P.M. Hallucination Adderall C Major Depression Movement Disorder Muscle Rigidity Nausea Tic Vomiting Date:03/20/98ISR Number: 3059778-4Report Type:Expedited (15-DaCompany Report #JAUK-38058 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Risperdal PS Janssen ORAL ORAL Decreased Health Captopril C Professional Dothiapen C Aspirin C Co-Proxamol C Date:03/25/98ISR Number: 3058932-5Report Type:Expedited (15-DaCompany Report #JAGER-38017 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Depressed Level Of Foreign Risperidon PS Janssen ORAL .5 MG DAILY Hospitalization - Consciousness Study ORAL Initial or Prolonged Sedation Health Placebo SS ORAL DAILY ORAL Professional Date:03/25/98ISR Number: 3058933-7Report Type:Expedited (15-DaCompany Report #JAUSA-31912 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Health Risperdal PS ORAL .5 ML 2 DAILY Initial or Prolonged Eye Movement Disorder Professional ORAL Lethargy Medication Error Sedation Date:03/25/98ISR Number: 3060633-4Report Type:Direct Company Report # Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Risperidone PS Janssen ORAL 0.5MG BID ORAL Lorazepam C Asa C Caco3 C Docusate/Casanthrama l C Levo Hyrokine C Sertraline C 22-Feb-2006 08:20 AM Page: 255 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/98ISR Number: 3137811-9Report Type:Periodic Company Report #9715024 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Zoloft PS ORAL 75.00 MG Drug Interaction Professional TOTAL; DAILY; Psychotic Disorder ORAL Risperdal SS ORAL 6.00 MG TOTAL; BID; ORAL Date:03/25/98ISR Number: 3213178-2Report Type:Periodic Company Report #JAUSA-32920 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Laboratory Test Abnormal Professional Date:03/30/98ISR Number: 3053555-6Report Type:Expedited (15-DaCompany Report #JACAN-16588 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Risperdal PS Janssen ORAL 1 MG DAILY Hospitalization - Haematuria Health ORAL Initial or Prolonged Hypothermia Professional Risperdal SS ORAL 1.5 MG DAILY Sepsis ORAL Upper Respiratory Tract Sinement Cr C Infection Adalat Xl C Asa C Date:03/30/98ISR Number: 3059106-4Report Type:Expedited (15-DaCompany Report #JACAN-16678 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Risperdal PS Janssen ORAL ORAL; ON FOR Hospitalization - Coma Consumer ABOUT 1 YEAR, Initial or Prolonged Paralysis 5 YEARS AGO 12 MON Tremor Haldol SS Janssen ORAL ORAL Ativan SS TABLET; ORAL Date:03/30/98ISR Number: 3059107-6Report Type:Expedited (15-DaCompany Report #JAFRA-38346 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Risperdal PS Janssen ORAL ORAL Initial or Prolonged Health Professional Date:03/30/98ISR Number: 3059109-XReport Type:Expedited (15-DaCompany Report #JABEL-38319 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperidone PS Janssen Health Professional 22-Feb-2006 08:20 AM Page: 256 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/30/98ISR Number: 3059110-6Report Type:Expedited (15-DaCompany Report #JABEL-38320 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperidone PS Janssen Health Professional Date:03/30/98ISR Number: 3059111-8Report Type:Expedited (15-DaCompany Report #JACAN-16681 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal PS ORAL ORAL Health Professional Date:03/30/98ISR Number: 3059112-XReport Type:Expedited (15-DaCompany Report #JACAN-16682 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal PS Janssen ORAL ORAL Health Professional Date:03/30/98ISR Number: 3059114-3Report Type:Expedited (15-DaCompany Report #JAUSA-31919 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Weight Increased Health Risperdal PS Janssen ORAL 6 MG 2 DAILY Professional ORAL Date:03/30/98ISR Number: 3059116-7Report Type:Expedited (15-DaCompany Report #JAUSA-31920 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Risperdal PS Janssen ORAL RECEIVED 3 Life-Threatening Blood Chloride Increased Professional DOSES, .5MG Blood Creatinine AT HS ON Increased 2/16/98, .5MG Blood Glucose Increased AM, PM ON Blood Urea Increased Levofloxacin SS ORAL 500 MG 4 Hypernatraemia DAILY ORAL Hypokalaemia Ibuprofen C Infection Megace C Pco2 Decreased Multivitamins C Pneumonia Aspiration Respiratory Arrest Date:03/31/98ISR Number: 3067083-5Report Type:Direct Company Report # Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Risperidone PS ORAL PO Initial or Prolonged Dysphagia 22-Feb-2006 08:20 AM Page: 257 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/98ISR Number: 3058796-XReport Type:Expedited (15-DaCompany Report #JAUSA-30704 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Risperdal PS Janssen ORAL ORAL 10 MON Life-Threatening Professional Date:04/01/98ISR Number: 3058807-1Report Type:Expedited (15-DaCompany Report #980324-008010997 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Depression Foreign Haloperidol PS ORAL ONCE, ORAL Suicide Attempt Health Doxepin SS ORAL ONCE, ORAL Professional Diclofenac SS ORAL ONCE, ORAL Risperidone SS ORAL ONCE, ORAL Alcohol SS ORAL ONCE, ORAL Date:04/01/98ISR Number: 3065084-4Report Type:Direct Company Report # Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Risperidone PS ORAL 4MG BID PO Initial or Prolonged Hypothermia Klonopin C Date:04/02/98ISR Number: 3064045-9Report Type:Expedited (15-DaCompany Report #980327-008011067 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Haldol PS ORAL 4.5 MG QD, Hospitalization - Drug Ineffective Health ORAL Initial or Prolonged Hallucination, Auditory Professional Risperidone SS ORAL 1 MG, QD ORAL Levomepromazine SS ORAL 15 MG, QD, ORAL Date:04/03/98ISR Number: 3061341-6Report Type:Expedited (15-DaCompany Report #980316-008010925 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Health Haloperidol PS ORAL ORAL Hospitalization - Paralysis Professional Risperidone SS ORAL ORAL 12 MON Initial or Prolonged Lorazepam SS ORAL ORAL Date:04/06/98ISR Number: 3063086-5Report Type:Expedited (15-DaCompany Report #VARCY-38555 Age:28 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal PS Janssen ORAL -,ORAL Health Professional Date:04/06/98ISR Number: 3063089-0Report Type:Expedited (15-DaCompany Report #JACAN-16706 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Death Death Foreign Health 22-Feb-2006 08:20 AM Page: 258 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal PS Janssen ORAL -, ORAL Date:04/06/98ISR Number: 3063091-9Report Type:Expedited (15-DaCompany Report #JAUK-37925 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Systemic Lupus Foreign Risperidone PS Janssen ORAL 3 MG 2 DAILY Erythematosus Health ORAL Urticaria Professional Epilim C Date:04/06/98ISR Number: 3063093-2Report Type:Expedited (15-DaCompany Report #JAGER-38471 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal PS Janssen ORAL 6 MG DAILY ; Initial or Prolonged Phosphokinase Increased Health ORAL Brain Oedema Professional Risperdal SS Janssen ORAL 4 MG DAILY; Hyponatraemia ORAL Leukocytosis Polydipsia Pyrexia Sedation Water Intoxication Date:04/06/98ISR Number: 3063095-6Report Type:Expedited (15-DaCompany Report #JAKYO-38525 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ileus Paralytic Foreign Risperidone PS Janssen ORAL 2 MG DAILY Health ORAL 6 MON Professional Date:04/06/98ISR Number: 3063096-8Report Type:Expedited (15-DaCompany Report #JACAN-16700 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Risperdal PS Janssen ORAL -, ORAL 2 MON Health Professional Date:04/06/98ISR Number: 3063098-1Report Type:Expedited (15-DaCompany Report #JAKYO-37811 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Risperidone PS Janssen ORAL 4 MG DAILY Leukopenia Health ORAL Professional Trihexyphenidyl SS ORAL 4 MG DAILY ORAL Flunitrazepam SS ORAL 4 MG DAILY ORAL 5 DAY Antibiot. Unspec. C 22-Feb-2006 08:20 AM Page: 259 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/98ISR Number: 3063100-7Report Type:Expedited (15-DaCompany Report #JACAN-16681 Age:84 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal PS Janssen ORAL 0.5-1MG Condition Aggravated Health DAILY;ORAL Professional Nardil SS ORAL -,SINGLE ORAL Date:04/06/98ISR Number: 3063102-0Report Type:Expedited (15-DaCompany Report #JACAN-16682 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Foreign Risperdal PS Janssen ORAL DAILY ORAL Health Nardil SS ORAL -,ORAL Professional Date:04/09/98ISR Number: 3062298-4Report Type:Expedited (15-DaCompany Report #JAUSA-31919 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Health Risperdal PS Janssen ORAL 10 MG DAILY Drug Level Above Professional ORAL Therapeutic Haldol C Electrocardiogram Qt Sertraline C Prolonged Pepcid C Hepatomegaly Temazepam C Splenomegaly Date:04/09/98ISR Number: 3134567-0Report Type:Periodic Company Report #JAUSA-27851 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone) PS Janssen ORAL TABLET, 4 MG DAILY ORAL Date:04/10/98ISR Number: 3062328-XReport Type:Expedited (15-DaCompany Report #JAGER-38017 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Risperidone PS Janssen .5MG DAILY Hospitalization - Apallic Syndrome ORAL Initial or Prolonged Blood Creatinine Placebo SS DAILY ORAL Increased Blood Urea Abnormal Brain Hypoxia Cardiac Failure Condition Aggravated Encephalitis Oliguria Renal Impairment Sedation Sepsis 22-Feb-2006 08:20 AM Page: 260 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/10/98ISR Number: 3062769-0Report Type:Expedited (15-DaCompany Report #JAUSA-32035 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Consumer Risperdal PS Janssen ORAL 30 ML SINGLE Pneumonia ORAL Date:04/13/98ISR Number: 3063899-XReport Type:Expedited (15-DaCompany Report #JAKYO-38525 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colonic Obstruction Foreign Risperidone PS Janssen ORAL 2 MG DAILY Initial or Prolonged Constipation Health ORAL Ileus Paralytic Professional Date:04/13/98ISR Number: 3063901-5Report Type:Expedited (15-DaCompany Report #JAUSA-32169 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Consumer Risperdal PS Janssen ORAL 3 MG 2 DALIY Initial or Prolonged Chromaturia ORAL 2 YR Dyskinesia Benztropine C Embolism L-Dopa C Hyperhidrosis Muscle Rigidity Myalgia Pyrexia Tachycardia Tremor Weight Decreased Date:04/13/98ISR Number: 3063902-7Report Type:Expedited (15-DaCompany Report #JAKYO-37432 Age:1 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Artery Occlusion Foreign Risperidone PS Janssen ORAL 1 MG DAILY Initial or Prolonged Cerebral Infarction Health ORAL Disability Complications Of Maternal Professional Pipamperone C Exposure To Therapeutic Other Ethyl Loflazepate C Drugs Trihexyphenidyl C Hemiplegia Brotizolam C Moyamoya Disease Date:04/14/98ISR Number: 3063979-9Report Type:Expedited (15-DaCompany Report #980409-008011213 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Foreign Haloperidol PS ORAL 5MG/QD/ORAL Health Risperidone SS ORAL ORAL Professional Date:04/14/98ISR Number: 3072758-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retrograde Ejaculation Risperdal PS ORAL 2MG BID PO Testicular Pain 22-Feb-2006 08:20 AM Page: 261 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/98ISR Number: 3073112-5Report Type:Direct Company Report # Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dysarthria Health Risperidone PS 1 MG BID Intervention to Lethargy Professional Levaquin C Prevent Permanent Miosis Atrovent C Impairment/Damage Muscle Rigidity Multivitamin C Neuroleptic Malignant Pepcid C Syndrome Flovent C Pyrexia Date:04/15/98ISR Number: 3065649-XReport Type:Expedited (15-DaCompany Report #JAUSA-31920 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Risperdal PS OCCLUSIVE Life-Threatening Blood Creatinine Professional DRESSING .5 MG 2 DAILY Increased ORAL Medication Error Levofloxacin SS ORAL 500 MG 4 Pneumonia Aspiration DAILY ORAL Respiratory Arrest Motrin C Megace C Multivitamins C Synthroid C Date:04/15/98ISR Number: 3065650-6Report Type:Expedited (15-DaCompany Report #JAUSA-32160 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Health Risperdal PS Janssen ORAL 8 MG DAILY Initial or Prolonged Chest Pain Professional ORAL Drug Ineffective Parnate (Tranylcypromine) C Vasotec (Enalapril) C Date:04/15/98ISR Number: 3071771-4Report Type:Direct Company Report # Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ejaculation Failure Risperidol PS ORAL 5MG DAILY PO 9 MON Sexual Dysfunction Date:04/15/98ISR Number: 3071908-7Report Type:Direct Company Report # Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Binocular Eye Movement Risperidone PS Initial or Prolonged Disorder Musculoskeletal Stiffness Date:04/16/98ISR Number: 3072564-4Report Type:Direct Company Report #CTU 80962 Age:69 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:20 AM Page: 262 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Disorientation Health Risperidone PS ORAL 0.5 MG PO BID Hypervolaemia Professional Phenobarbital C Hyponatraemia Depakote C Lethargy Date:04/17/98ISR Number: 3154412-7Report Type:Periodic Company Report #JAUSA-31677 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Increased Health Risperdal Initial or Prolonged Professional (Risperidone) PS Janssen ORAL ORAL-30 ML 2 SINGLE Date:04/17/98ISR Number: 3154419-XReport Type:Periodic Company Report #JAUSA-31404 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paranoia Health Risperdal Sedation Professional (Risperidone) PS Janssen RESPIRATORY (INHALATION) INHALATION Date:04/17/98ISR Number: 3154426-7Report Type:Periodic Company Report #JAUSA-31391 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Consumer Risperdal (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL- 2.5 MG 1 DAILY ORAL Estrogens C Vitamin E C Multivit C Zoloft C Date:04/17/98ISR Number: 3154428-0Report Type:Periodic Company Report #JAUSA-31166 Age:5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Above Consumer Risperdal PS Janssen ORAL 1.5 MG DAILY Therapeutic ORAL-0.25 MG Hepatic Function Abnormal IN AM, 0.25 IN AFTERNOON, 1 MG AT Tegretal (Carbamazepine) SS Date:04/20/98ISR Number: 3065264-8Report Type:Expedited (15-DaCompany Report #JAGER-38649 Age:29 YR Gender:Male I/FU:I Outcome PT Other Aspiration Blood Creatine Phosphokinase Increased 22-Feb-2006 08:20 AM Page: 263 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Suicide Attempt Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal PS Janssen ORAL ORAL Health Biperiden SS ORAL ORAL Professional Taxilan SS ORAL PO Neogama SS Deprilept SS Date:04/20/98ISR Number: 3065265-XReport Type:Expedited (15-DaCompany Report #JACAN-16700 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Risperdal PS Janssen ORAL ORAL 2 MON Initial or Prolonged Health Professional Date:04/20/98ISR Number: 3066560-0Report Type:Expedited (15-DaCompany Report #JAGER-38649 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspiration Foreign Risperidal PS ORAL ORAL Blood Creatine Health Bisperiden SS ORAL ORAL Phosphokinase Increased Professional Taxilan SS ORAL ORAL Somnolence Neogama SS ORAL ORAL Suicide Attempt Deprilept SS ORAL ORAL Tachycardia Date:04/20/98ISR Number: 3066562-4Report Type:Expedited (15-DaCompany Report #JACAN-16700 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Risperdal PS ORAL ORAL 2 MON Initial or Prolonged Health Professional Date:04/20/98ISR Number: 3071853-7Report Type:Direct Company Report # Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Apathy Health Risperdal PS Janssen Pharmaceutic 1 MG Difficulty In Walking Professional BID(4/7-4/8); Flat Affect 0.5MG Gait Disturbance BID(4/8-4/11) Lack Of Spontaneous .. SS Speech Date:04/22/98ISR Number: 3071698-8Report Type:Direct Company Report # Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Health Risperidone PS ORAL . 5 MG QD Movement Disorder Professional Parkinsonism 22-Feb-2006 08:20 AM Page: 264 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/98ISR Number: 3066933-6Report Type:Expedited (15-DaCompany Report #JAUSA-32169 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY Initial or Prolonged Chromaturia ORAL Embolism Benztropine C Hyperhidrosis L-Dopa C Muscle Rigidity Myalgia Neuroleptic Malignant Syndrome Parkinsonism Pyrexia Tachycardia Tremor Weight Decreased Date:04/23/98ISR Number: 3066935-XReport Type:Expedited (15-DaCompany Report #JACAN-16726 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Risperdal PS Janssen ORAL 3 MG 2 DAILY Initial or Prolonged Drug Abuser Health ORAL Professional Procyclifine C Clonazepam C Date:04/23/98ISR Number: 3071831-8Report Type:Direct Company Report # Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Health Clozaril PS ORAL 100MG QAM, Hallucination Professional 50MG QNOON, Nocturia 300MG QHS Suicidal Ideation Risperdal SS ORAL 3MG QAM + Urinary Retention 1.5MG QHS Date:04/23/98ISR Number: 3072744-8Report Type:Direct Company Report # Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperidone PS 0.5MG BID Lorazepam C D.S.S. C Casanthranol C Sertraline C Aspirin C Calcium Carbonate C Beclomethasone C Levothyroxine C Date:04/23/98ISR Number: 3073182-4Report Type:Direct Company Report # Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Risperidone PS 2 MG Q AM 22-Feb-2006 08:20 AM Page: 265 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/24/98ISR Number: 3072360-8Report Type:Direct Company Report # Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Clomiptanzine PS ORAL 50 MG HS PO; Initial or Prolonged THERAPY FOR SEVERAL MONTHS Venlafaxine SS ORAL 300 MG QD, PO Risperidone SS ORAL PO HS 1 WK Metformin C Abmlen C Date:04/24/98ISR Number: 3072425-0Report Type:Direct Company Report # Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram St Risperdal PS Janssen 1ST 2 DAYS Disability Segment Depression .5MG QD; NEXT Mental Impairment 2 DAYS .5 MG Orthostatic Hypotension Syncope Date:04/26/98ISR Number: 3066938-5Report Type:Expedited (15-DaCompany Report #JAUSA-32288 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Consumer Risperdal PS Janssen ORAL 5 MG DAILY Breast Mass ORAL Date:04/27/98ISR Number: 3071222-XReport Type:Expedited (15-DaCompany Report #JAUK-38835 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Risperdal PS Janssen .5 MG 2 DAILY Initial or Prolonged Hypothermia ORAL Pancreatitis Acute Sinemet C Date:04/27/98ISR Number: 3071224-3Report Type:Expedited (15-DaCompany Report #JAFRA-37920 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Fibrinogen Foreign Risperdal PS Janssen ORAL 2 MG DAILY Initial or Prolonged Decreased Health ORAL Coagulation Time Professional Loxapac C Shortened Loxapac C Neutropenia Lepticur C Platelet Count Decreased Theralene C Thrombocytopenia Date:04/27/98ISR Number: 3075320-6Report Type:Expedited (15-DaCompany Report #JACAN-16729 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Risperdal PS Janssen ORAL 1 YR Health Arthrotec C Professional 22-Feb-2006 08:20 AM Page: 266 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/98ISR Number: 3072055-0Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Parkinsonism Risperidone PS Trazodone SS Date:04/29/98ISR Number: 3070550-1Report Type:Expedited (15-DaCompany Report #980421-008011344 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Foreign Haloperidol PS ORAL 9 MG QD Initial or Prolonged Health Risperidone SS ORAL 3 MG QD Professional Trihexyphenidyl SS ORAL 3 MG QD Flunitrazepam SS ORAL 2 MG QD Mexazolam SS ORAL 2 MG QD Date:04/29/98ISR Number: 3073016-8Report Type:Expedited (15-DaCompany Report #USA/98/00619/LEX Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Clozaril PS ORAL 450 MG ORAL Initial or Prolonged Hallucination Professional Risperdal SS ORAL 4.5 MG ORAL Required Nocturia Prozac C Intervention to Suicidal Ideation Prevent Permanent Urinary Retention Impairment/Damage Date:04/30/98ISR Number: 3070686-5Report Type:Expedited (15-DaCompany Report #9800488 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Zoloft PS ORAL 50.00 MG Hospitalization - Bipolar Disorder Professional TOTAL:DAILY:O Initial or Prolonged Blood Lactate RAL Dehydrogenase Decreased Xanax SS Blood Sodium Decreased Lithium SS ORAL 900.00 MG Eye Movement Disorder TOTAL:TID:ORA Haematuria L Ketonuria Risperidone SS ORAL 9.00 MG Movement Disorder TOTAL:TID:ORA Nervous System Disorder L Urinary Tract Infection Cogentin C Ativan C Restoril C Haldol Decanoate C Haldol C Date:04/30/98ISR Number: 3070689-0Report Type:Expedited (15-DaCompany Report #9800488 Age:19 YR Gender:Male I/FU:I Outcome PT Death Abdominal Pain Hospitalization - Blood Lactate Initial or Prolonged Dehydrogenase Decreased Blood Sodium Decreased Eye Movement Disorder Haematuria 22-Feb-2006 08:20 AM Page: 267 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ketonuria Movement Disorder Nervous System Disorder Report Source Product Role Manufacturer Route Dose Duration Overdose Health Zoloft PS ORAL 50.00 MG Urinary Tract Infection Professional TOTAL:DAILY:O RAL Xanax SS Lithium SS ORAL 900.00 MG TOTAL:TID:ORA L Risperidone SS ORAL 9.00 MG TOTAL:TID:ORA L Cogentin C Ativan C Restoril C Haldol Decanoate C Haldol C Date:04/30/98ISR Number: 3073829-2Report Type:Direct Company Report # Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Risperdal PS ORAL 2 MG X2 DAYS Hospitalization - Syndrome Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:05/01/98ISR Number: 3073733-XReport Type:Expedited (15-DaCompany Report #JACAN -16726 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Risperdal PS Janssen ORAL 3 MG 2 DAILY Palpitations Health ORAL Sinus Tachycardia Professional Procyclidine C Clonazepam C Date:05/04/98ISR Number: 3073982-0Report Type:Expedited (15-DaCompany Report #JACAN-16700 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Risperdal PS ORAL 2MG 2 DAILY Initial or Prolonged Reticulocyte Count Health ORAL Decreased Professional Effexor C Rivotril C Manerix C Date:05/04/98ISR Number: 3073983-2Report Type:Expedited (15-DaCompany Report #JASWE-37681 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cutaneous Vasculitis Foreign Risperidone PS Janssen ORAL .5 MG 2 DAILY Initial or Prolonged Streptococcal Infection Health ORAL Professional Effexor SS ORAL 225MG DAILY 22-Feb-2006 08:20 AM Page: 268 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:05/05/98ISR Number: 3087869-0Report Type:Direct Company Report # Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Risperdal PS ORAL 0.5MG Q HS PO Drooling Monopril C Fall Sedation Urinary Incontinence Date:05/07/98ISR Number: 3074526-XReport Type:Expedited (15-DaCompany Report #9810990 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Zoloft PS ORAL 150.00 MG Psychotic Disorder Health (TABLET) Suicide Attempt Professional TOTAL:DAILY Company Risperidone SS ORAL 1.00 MG Representative TOTAL:DAILY Date:05/11/98ISR Number: 3084218-9Report Type:Direct Company Report # Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Risperidol PS ORAL 1MG TID PO 2 YR Initial or Prolonged Date:05/13/98ISR Number: 3076112-4Report Type:Direct Company Report # Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lethargy Risperdal PS 0.5MG BID VIA G TUBE Valproic Acid C Questran C Nitrodur Ii C Lanoxin C Lasix C Mycelex Cr C Coumadin C Flagyl C Lotrisone C Lomotil C Rocephin C Date:05/14/98ISR Number: 3078261-3Report Type:Expedited (15-DaCompany Report #KEM-71240598 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Retention Foreign Kemadrin PS ORAL 5 MG PER DAY Initial or Prolonged PO Risperidone SS ORAL .5 MG PER DAY PO Throxine Sodium C Sennosides C 22-Feb-2006 08:20 AM Page: 269 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chlormathiazole C Magnesium Sulfate C Date:05/14/98ISR Number: 3078264-9Report Type:Expedited (15-DaCompany Report #B0056325 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Retention Foreign Kemadrin PS ORAL 5 MG PER DAY Initial or Prolonged ORAL Risperidone SS ORAL .5 MG PER DAY ORAL Thyroxine Sodium C Chlormethiazole C Sennosides C Magnesium Sulfate C Date:05/14/98ISR Number: 3078913-5Report Type:Expedited (15-DaCompany Report #8-98125-052A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Foreign Effexor PS ORAL 450 MG ONE Initial or Prolonged Miosis Health TIME ORAL Overdose Professional Risperidone SS ORAL 10 MG ORAL Sedation Tachycardia Date:05/19/98ISR Number: 3080951-3Report Type:Expedited (15-DaCompany Report #JAUSA-31920 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Chloride Increased Health Risperdal PS ORAL .5 MG 1 DAILY Life-Threatening Blood Creatinine Professional ORAL/.5 MG 2 Increased DAILY Blood Glucose Increased Levofloxacin SS ORAL 500 MG 4 Blood Potassium Decreased DAILY ORAL Blood Urea Increased Motrin C Coma Megace C Lethargy Multivitamins C Lung Infiltration Synthroid C Pco2 Decreased Pneumonia Aspiration Pulmonary Congestion Respiratory Arrest Urinary Tract Infection Date:05/19/98ISR Number: 3080954-9Report Type:Expedited (15-DaCompany Report #JASWE-36976 Age:32 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Blister Blood Creatinine Increased C-Reactive Protein Increased Erysipelas Glomerulonephritis 22-Feb-2006 08:20 AM Page: 270 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatitis C Antibody Positive Ileus Paralytic Report Source Product Role Manufacturer Route Dose Duration Infection Foreign Risperidone PS ORAL 4 MG 2 DAILY Oliguria Health ORAL Renal Failure Professional Litarex C Vasculitis Cisordinol Depot C Date:05/19/98ISR Number: 3080958-6Report Type:Expedited (15-DaCompany Report #JAUK-37925 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Foreign Risperidone PS Janssen ORAL 3 MG 2 DAILY Gastric Cancer Health ORAL Urticaria Professional Epilim (Valproate Sodium) C Phenobarb (Phenobarbital) C Praquenil (Hydroxychloroquine) C Calvepen (Phenoxymethylpenici llin) C Prednisolone C Date:05/19/98ISR Number: 3080960-4Report Type:Expedited (15-DaCompany Report #JAFRA-39059 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Risperdal PS Janssen ORAL ORAL Health Teralithe (Lithium) C Professional Xanax C Tercian (Cyamemazine) C Botox C Date:05/19/98ISR Number: 3080961-6Report Type:Expedited (15-DaCompany Report #JABEL-39064 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Risperdal PS Janssen ORAL 1 MG 2 DAILY Myocardial Infarction Health ORAL Restlessness Professional Haldol Decanoas (Haloperidol Decanoate) C Asaflow (Acetylsalicylic-Aci d) C Sotalex (Sotalol) C Capoten C Corvaton (Molsidomine) C 22-Feb-2006 08:20 AM Page: 271 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/98ISR Number: 3080963-XReport Type:Expedited (15-DaCompany Report #JAUK-39049 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Foreign Risperdal PS Janssen ORAL 4 MG 1 DAILY Coronary Artery Disease Health ORAL Hyperhidrosis Professional Myocardial Infarction Date:05/21/98ISR Number: 3082104-1Report Type:Expedited (15-DaCompany Report #JAUSA-32661 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Initial or Prolonged Positive Professional ; 2 MG 2 Aplastic Anaemia DAILY ORAL Asthenia Zyrlex (Cetirizine) C Blood Immunoglobulin G Ativan (Lorazepam) C Increased Cogentin Bone Marrow Depression (Benztropine) C Ecchymosis .. C Erythema Infectiosum Gingival Bleeding Haemoglobin Decreased Hepatitis A Antibody Positive Hepatitis B Antibody Positive Infectious Mononucleosis Loss Of Consciousness Macrocytosis Pancytopenia Platelet Count Decreased White Blood Cell Count Decreased Date:05/21/98ISR Number: 3083176-0Report Type:Expedited (15-DaCompany Report #980421-008011344 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Foreign Haloperidol PS ORAL 9MG QD ORAL Initial or Prolonged Health Risperidone SS ORAL 3MG QD ORAL Professional Trihexyphenidyl SS ORAL 3MG QD ORAL Flunitrazepam SS ORAL 2MG, QD, ORAL Mexazolam SS ORAL 2MG QD ORAL Date:05/22/98ISR Number: 3081850-3Report Type:Expedited (15-DaCompany Report #9810990 Age:7 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Foreign Zoloft PS ORAL 150.00 MG Anger Health TOTAL:DAILY:O Anxiety Professional RAL Decreased Appetite Risperidone SS ORAL 0.50 MG Ecchymosis TOTAL:DAILY:O Emotional Disorder RAL Intentional Self-Injury Muscle Twitching Pain In Extremity 22-Feb-2006 08:20 AM Page: 272 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/22/98ISR Number: 3087328-5Report Type:Direct Company Report # Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Athetosis Risperdal PS ORAL 3 MG PO BID Intervention to Muscle Twitching Tardive Depkineria C Prevent Permanent Tardive Dyskinesia Impairment/Damage Date:05/23/98ISR Number: 3134577-3Report Type:Periodic Company Report #JAUSA-27923 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal PS Janssen ORAL 2 MG/1 MG 2 Initial or Prolonged Syndrome Professional DAILY ORAL/ SEE IMAGE Date:05/26/98ISR Number: 3082386-6Report Type:Expedited (15-DaCompany Report #PRIUS-36259 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Risperidone PS Janssen ORAL .5 MG 2 DAILY Hospitalization - Condition Aggravated Health ORAL Initial or Prolonged Depressed Level Of Professional Haldol SS Janssen ORAL .5 MG DAILY Consciousness ORAL Drug Interaction Aricept SS ORAL 5MG/DAILY/ORA Muscle Rigidity L 2 DAY Pyrexia Paroxetine C Sedation Anticoagulants C Subdural Haematoma Tremor Date:05/26/98ISR Number: 3082633-0Report Type:Expedited (15-DaCompany Report #JAUSA-32169 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Consumer Risperdal PS ORAL 3 MG 2 DAILY Initial or Prolonged Chromaturia ORAL/4 MG Embolism DAILY ORAL 9 DAY Hyperhidrosis L-Dopa C Muscle Rigidity Myalgia Neuroleptic Malignant Syndrome Parkinsonism Pyrexia Tachycardia Tongue Disorder Tremor Weight Decreased Date:05/26/98ISR Number: 3082635-4Report Type:Expedited (15-DaCompany Report #JASWE-36976 Age:32 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Anuria Blister 22-Feb-2006 08:20 AM Page: 273 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Creatinine Increased C-Reactive Protein Report Source Product Role Manufacturer Route Dose Duration Increased Foreign Risperidone PS ORAL 4 MG 2 DAILY Cutaneous Vasculitis Health ORAL Erysipelas Professional Litarex C Glomerulonephritis Cisordinol C Hepatitis C Hepatitis Viral Ileus Paralytic Infection Inflammation Renal Failure Vasculitis Date:05/26/98ISR Number: 3082638-XReport Type:Expedited (15-DaCompany Report #JAAUS-39273 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Crohn'S Disease Foreign Risperdal PS Janssen ORAL ORAL Health Professional Date:05/26/98ISR Number: 3082641-XReport Type:Expedited (15-DaCompany Report #JAGER-38795 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Foreign Risperidon PS ORAL 2 MG 1 DAILY Hospitalization - Femoral Neck Fracture Study ORAL Initial or Prolonged Health Placebo SS ORAL 1 DAILY ORAL Professional Date:05/26/98ISR Number: 3082644-5Report Type:Expedited (15-DaCompany Report #JACAN-16565 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Face Oedema Foreign Risperdal PS ORAL .5 MG ORAL Oedema Peripheral Health Cipro C Professional Atarax C Ativan C Dulcolax C Doxepin C Polysporin C Tetracycline C Bactroban C Betamethasone C Fucidin C Tylenol C Date:05/26/98ISR Number: 3082645-7Report Type:Expedited (15-DaCompany Report #HOAFF-39132 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Foreign Risperidone PS .5 MG 2 DAILY Parkinsonism Literature Sedation Health Professional 22-Feb-2006 08:20 AM Page: 274 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/98ISR Number: 3082647-0Report Type:Expedited (15-DaCompany Report #HOAFF-39131 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cognitive Disorder Foreign Risperidone PS .5 MG 1 DAILY 4 DAY Condition Aggravated Literature Health Professional Date:05/26/98ISR Number: 3082862-6Report Type:Expedited (15-DaCompany Report #980518-008011732 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Health Haloperidol PS ORAL 20 MG, QD, Initial or Prolonged Galactorrhoea Professional ORAL Pituitary Tumour Benign Risperidone SS ORAL 6 MG, QD, Psychotic Disorder ORAL/4 MG, Tremor QD, ORAL Doxepin SS ORAL 75 MG, QD, ORAL/100 MG, QD, ORAL Risperidone SS ORAL 4 MG, QD, ORAL Doxepin SS Risperidone SS ORAL 6 MG, QD, ORAL Medoxyprogesterone C Date:06/01/98ISR Number: 3087267-XReport Type:Direct Company Report # Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Accident Navane PS Hospitalization - Blood Disorder Respiradol SS Initial or Prolonged Convulsion Haldol SS Disability Ecchymosis Aspirin C Other Fatigue Nitropaste C Required Parkinson'S Disease Intervention to Pulmonary Congestion Prevent Permanent Sepsis Impairment/Damage Urinary Tract Infection Date:06/01/98ISR Number: 3088132-4Report Type:Expedited (15-DaCompany Report #JAUK-39233 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Foreign Risperidone PS Janssen 2MG DAILY Exposure To Therapeutic ORAL Drugs Hypoplastic Left Heart Syndrome Date:06/01/98ISR Number: 3088136-1Report Type:Expedited (15-DaCompany Report #ORGUK-39249 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Death Condition Aggravated Foreign Myocardial Infarction Health 22-Feb-2006 08:20 AM Page: 275 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal PS Janssen ORAL ORAL Date:06/01/98ISR Number: 3088140-3Report Type:Expedited (15-DaCompany Report #JAUK-39049 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arterial Thrombosis Foreign Risperdal PS Janssen ORAL 4 MG 1 DAILY Chest Pain ORAL; APPROX. Coronary Artery Disease DATE - USED Hyperhidrosis FOR 6 WEEKS. Loss Of Consciousness ASSUMED FORM. 6 WK Myocardial Infarction Date:06/01/98ISR Number: 3088142-7Report Type:Expedited (15-DaCompany Report #JAUK-38058 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Risperdal PS Janssen ORAL 500 MCG 1 Decreased DAILY ORAL Non-Hodgkin'S Lymphoma Aspirin C White Blood Cell Count Folic Acid C Decreased Date:06/01/98ISR Number: 3088266-4Report Type:Expedited (15-DaCompany Report #JAUSA-32693 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen ORAL 8 MG DAILY Professional ORAL Mellaril SS 75 MG DAILY/PRN Pamelor C Date:06/01/98ISR Number: 3088268-8Report Type:Expedited (15-DaCompany Report #JAUSA-32695 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen ORAL 10 MG DAILY Professional ORAL Mellaril SS 800 MG DAILY/PRN Date:06/02/98ISR Number: 3088664-9Report Type:Direct Company Report # Age:88 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradykinesia Risperidone PS ORAL #1: 0.5 MG Extrapyramidal Disorder QHS PO; #2: Muscle Rigidity 1MG QHS PO Tremor Risperidone SS ORAL #3: 1 MG BID PO; #4: 1.5MG QD PO Snythroid C 22-Feb-2006 08:20 AM Page: 276 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multivitamin C Doss C Oscal C Vitamin B12 C Date:06/02/98ISR Number: 3088829-6Report Type:Direct Company Report # Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Rispiridone PS ORAL 1MG PO BID; Required Psychotic Disorder 2MG PO BID Intervention to Clonazepam C Prevent Permanent Divalproex C Impairment/Damage Olanzapine C Paxil C Date:06/02/98ISR Number: 3161044-3Report Type:Periodic Company Report #7394797 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Abbott-Biaxin PS Abbott ORAL 250.000MG PO Dystonia Professional BID Torticollis Risperdal SS ORAL 3.000MG PO QD Date:06/04/98ISR Number: 3090212-4Report Type:Expedited (15-DaCompany Report #JAUSA-28046 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Literature Risperdal PS Janssen ORAL Initial or Prolonged Hypotension Health Intentional Overdose Professional Lethargy Orthostatic Hypotension Suicide Attempt Date:06/08/98ISR Number: 3091282-XReport Type:Expedited (15-DaCompany Report #JAUSA-32270 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Professional Klonopin C Paxil C Date:06/08/98ISR Number: 3091625-7Report Type:Expedited (15-DaCompany Report #8-98149-002A Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Foreign Surmontil PS ORAL 28 TABLETS Initial or Prolonged Overdose Health ORAL Professional Chloral Hydrate SS ORAL 30 TABLETS ORAL Risperidone SS ORAL ORAL Sertraline SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 277 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/98ISR Number: 3091987-0Report Type:Expedited (15-DaCompany Report #JAKYO-39383 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Foreign Risperidone PS Janssen ORAL 2 MG DAILY Initial or Prolonged Health ORAL Professional Mosapramine C Levomepromazine C Triazolam C Saiko-Ka-Ryukotsu-Bo rei-To (Chinese Herbs) C Oren-Gedoku-To (Chinese Herbs) C Date:06/08/98ISR Number: 3091991-2Report Type:Expedited (15-DaCompany Report #JAGER-38795 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperidone PS ORAL 2 MG 1 DAILY Hospitalization - Fall Study ORAL Initial or Prolonged Femur Fracture Health Placebo SS ORAL -, 1 DAILY Shock Professional ORAL; SOLUTION Lasix 40 C Ismo 20 C Novodigal C Date:06/08/98ISR Number: 3091993-6Report Type:Expedited (15-DaCompany Report #ORGUK-39249 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Risperdal PS Janssen ORAL .5 MG 2 DAILY Myocardial Infarction Health ORAL Professional Date:06/10/98ISR Number: 3092370-4Report Type:Expedited (15-DaCompany Report #JAFRA-38346 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Risperdal PS Janssen ORAL ORAL Initial or Prolonged Neutropenia Date:06/10/98ISR Number: 3092372-8Report Type:Expedited (15-DaCompany Report #JAUK-39316 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphopenia Foreign Risperidone PS Janssen ORAL 2 MG DAILY Initial or Prolonged Monocytosis ORAL Neutropenia Folic Acid C Platelet Count Decreased Simple Linctus Bp C 22-Feb-2006 08:20 AM Page: 278 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/11/98ISR Number: 3092748-9Report Type:Expedited (15-DaCompany Report #LIT/98/00131/LEX Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Literature Leponex PS ORAL 150 MG ORAL 2 WK Initial or Prolonged Ammonia Increased Health Risperidone SS Required Anorexia Professional Lithium C Intervention to Aspartate Clonazepam C Prevent Permanent Aminotransferase Niacin-Hypercholeste Impairment/Damage Blood Alkaline rolemia C Phosphatase Pantothenic Acid C Blood Bilirubin Increased Multivitamin C Chromaturia Chromium Picolonate C Cough Eosinophilia Gamma-Glutamyltransferase Increased Haematuria Headache Hepatitis B Hyperglycaemia Malaise Nausea Pleural Effusion Pleuritic Pain Proteinuria White Blood Cell Count Increased Date:06/11/98ISR Number: 3092847-1Report Type:Expedited (15-DaCompany Report #JAUSA-32885 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen ORAL 3 MG 1 DAILY Professional ORAL Date:06/11/98ISR Number: 3092848-3Report Type:Expedited (15-DaCompany Report #JAAUS-39273 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Crohn'S Disease Foreign Risperdal PS Janssen ORAL 6 MG 2 DAILY Initial or Prolonged Irritable Bowel Syndrome Health ORAL Disability Professional Date:06/12/98ISR Number: 3093131-2Report Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Risperidone PS Initial or Prolonged Risperdal SS 3MG BID Other Depakote C Date:06/12/98ISR Number: 3093144-0Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Blood Creatine 22-Feb-2006 08:20 AM Page: 279 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphokinase Increased Depressed Level Of Consciousness Hypernatraemia Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Risperdal PS ORAL 1.5 MG PO BID Pyrexia Haldol SS INTRAMUSCULAR 5MG TID PRN Tachycardia N/IM 3 DAY Tremor Rocephin C Doxycycline C Zovirax C Date:06/12/98ISR Number: 3093154-3Report Type:Direct Company Report # Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Risperidone PS ORAL 1MG TAB 0.5MG Tongue Oedema BID PO Urinary Incontinence Tylenol C Baclofen C Diazepam C Famotidine C Hctz C Lisinopril C Daypro C Dilantin C Compazine C Psyllium C Date:06/12/98ISR Number: 3093712-6Report Type:Expedited (15-DaCompany Report #9815361 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Zoloft PS ORAL ORAL Initial or Prolonged Priapism Professional Risperidone SS Company Representative Date:06/16/98ISR Number: 3093913-7Report Type:Direct Company Report # Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Risperdal PS .5 MG BID Difficulty In Walking Drug Tolerance Decreased Muscle Rigidity Musculoskeletal Stiffness Neck Deformity Nervous System Disorder Neuroleptic Malignant Syndrome Parkinson'S Disease Stupor Tremor Urinary Incontinence 22-Feb-2006 08:20 AM Page: 280 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/18/98ISR Number: 3095349-1Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Mellaril PS ORAL 300MG PO Q Coma AM/500MG PO Q PM 3 MON Risperidone SS 5MG BID 6 MON Colace C Motrin C Aspirin Ii C Date:06/18/98ISR Number: 3095457-5Report Type:Expedited (15-DaCompany Report #HOAFF-39505 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Risperidone PS Janssen ORAL 4 MG DAILY Literature ORAL Health Professional Date:06/18/98ISR Number: 3097309-3Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Risperdal PS Janssen ORAL 4 MG, BID PO Coronary Artery Disease Thioridazine SS ORAL 100 MG , QHS, Coronary Artery Occlusion PO + 100 MG PRN. Nortriptyline C Disulfiram C Date:06/22/98ISR Number: 3097081-7Report Type:Expedited (15-DaCompany Report #JAKYO-39553 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Risperidone PS Janssen ORAL ORAL Rhabdomyolysis Health Clocapramine SS Professional Brotizolam C Dipyridamole C Nitrazepam C Sodium Picosulfate C Magnesium Oxide C Date:06/22/98ISR Number: 3097083-0Report Type:Expedited (15-DaCompany Report #JAGER-39534 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal PS Janssen ORAL 6 MG DAILY Phosphokinase Increased ORAL Gastroenteritis Furosemide C Infection Dociton C Pyrexia Gastrozeptin Rhabdomyolysis (Pirenzepine) C 22-Feb-2006 08:20 AM Page: 281 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/22/98ISR Number: 3097085-4Report Type:Expedited (15-DaCompany Report #JAUSA-32989 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer In Situ Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Myocardial Infarction Professional ORAL Synthroid C Lipitor C Insulin C Date:06/22/98ISR Number: 3097222-1Report Type:Expedited (15-DaCompany Report #JABEL-39064 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Risperdal PS Janssen ORAL 1 MG 2 DAILY Anxiety Health ORAL 3 MON Myocardial Infarction Professional Haldol C Asaflow C Sotalex C Capoten C Corvation C Date:06/24/98ISR Number: 3097949-1Report Type:Expedited (15-DaCompany Report #JAUSA-33009 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Angiopathy Health Risperdal PS ORAL ORAL Arteriosclerosis Professional Valproic Acid C Lorazepam C Propoxyphene C Chloroiazepoxide C Darvocet-N C Folic Acid C Date:06/26/98ISR Number: 3100285-8Report Type:Expedited (15-DaCompany Report #JACAN-16796 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal PS Janssen ORAL 9 MG 1 DAILY Health ORAL Professional Gabapentin (Gabapentin) C Lorazepam (Lorazepam) C Date:06/26/98ISR Number: 3100286-XReport Type:Expedited (15-DaCompany Report #JACOL-39714 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Risperidone PS Janssen ORAL ORAL Health Professional 22-Feb-2006 08:20 AM Page: 282 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/98ISR Number: 3100287-1Report Type:Expedited (15-DaCompany Report #JAFRA-39660 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Conjunctivitis Foreign Risperdal PS Janssen ORAL ORAL Initial or Prolonged Myasthenic Syndrome Health Tercian Scleritis Professional (Cyamemazine) C Imovane C Date:06/26/98ISR Number: 3100290-1Report Type:Expedited (15-DaCompany Report #JACAN-16565 Age:103 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Risperdal PS Janssen ORAL .5 MG ORAL; Cardiac Arrest Health .5 MG 3 DAILY Cardiac Failure Professional ORAL; 1 MG 2 Congestive DAILY ORAL 9 DAY Dementia Atarax C Fluid Retention Ativan C Mitral Valve Incompetence Dulcolax C Oedema Doxepin C Polysporin C Tetracycline C Bactroban C Betamethasone C Fudicin C Tylenol C Date:06/26/98ISR Number: 3100293-7Report Type:Expedited (15-DaCompany Report #JAGER-38017 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Risperidone PS Janssen ORAL .5 MG DAILY Hospitalization - Apallic Syndrome Study ORAL Initial or Prolonged Blood Creatinine Health Placebo SS ORAL DAILY ORAL Increased Professional Mcp (Metoclopramide) C Blood Urea Increased Nystatin (Nystatin) C Brain Hypoxia Pasta Cordes (Pasta Depressed Level Of Cordes (R)) C Consciousness Linola-Fett N Encephalitis (Linola-Fett N (R)) C Oliguria Effekton Renal Impairment (Diclofenac) C Sedation Darebon (Darebon Sepsis (R)) C Shock Dridase (Oxybutynine) C Solidargoren (Solidago (R)) C Ambroxol (Ambroxol) C Date:06/26/98ISR Number: 3100330-XReport Type:Expedited (15-DaCompany Report #JAUSA-33061 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Risperdal Initial or Prolonged Hypotension Professional (Risperidone) PS Janssen ORAL .5 MG 2 DAILY Hypothermia ORAL Pancytopenia Synthroid 22-Feb-2006 08:20 AM Page: 283 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Levothyroxine) C Date:06/26/98ISR Number: 3100332-3Report Type:Expedited (15-DaCompany Report #HOAFF-39132 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Risperidone PS Janssen .5 MG 2 DAILY Confusional State Literature Parkinsonism Health Sedation Professional Date:06/26/98ISR Number: 3100333-5Report Type:Expedited (15-DaCompany Report #JACAN-16729 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Risperdal PS Janssen ORAL 2 MG 2 DAILY Thrombocytopenia Health ORAL Professional Arthrotec (Arthrotec (R)) C Date:06/26/98ISR Number: 3100336-0Report Type:Expedited (15-DaCompany Report #HOAFF-39131 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cognitive Disorder Foreign Risperidone PS Janssen .5 MG 1 DAILY 4 DAY Literature Health Professional Date:06/29/98ISR Number: 3101897-8Report Type:Periodic Company Report #KEM-51110398 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Kemadrin PS ORAL 5 MG ONCE IN Other AM PO Risperidone (Formulation Unk) SS Nifedipine C Haloperidol C Date:06/29/98ISR Number: 3173374-XReport Type:Periodic Company Report #7395796 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Other Abbott - Depakote PS Abbott ORAL 750.000MG PO Increased QD Aspartate Risperdal SS UNKNOWN UNK Aminotransferase Increased Jaundice Nausea Vomiting 22-Feb-2006 08:20 AM Page: 284 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/98ISR Number: 3099905-6Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eyelid Ptosis Risperidone PS Janssen ORAL ORAL Initial or Prolonged Facial Palsy Buproprion C Musculoskeletal Stiffness Methylphenidate C Neck Pain Pain In Jaw Date:06/30/98ISR Number: 3100061-6Report Type:Expedited (15-DaCompany Report #90578 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Health Versed PS INTRAVENOUS 5 MG 1 X PER Disorientation Professional ONE DOSE Feeling Jittery Other INTRAVENOUS Hallucination, Visual Paxil SS ORAL ORAL Hypoaesthesia Risperdal SS ORAL 1 DOSE FORM 1 Sensory Loss X PER DAY Tremor ORAL Demerol C Date:07/01/98ISR Number: 3104422-0Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Ativan PS Medication Error Buspar SS Psychotic Disorder Cardura SS Depakote SS Desyrel SS Haldol SS Mellaril SS Neurontin SS Propilsid SS Risperdal SS Date:07/02/98ISR Number: 3101025-9Report Type:Expedited (15-DaCompany Report #JAUSA-32693 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Coronary Artery Disease Professional ORAL STOPPED; Coronary Artery Occlusion 4 MG 2 DAILY ORAL Mellaril SS ORAL 100 MG 1 DAILY ORAL; ALSO 100 MG GIVEN PRN. TAKEN AT Pamelor C Disulfiram C 22-Feb-2006 08:20 AM Page: 285 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/98ISR Number: 3101027-2Report Type:Expedited (15-DaCompany Report #JAUSA-33165 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Convulsion Professional ORAL / 1 MG Fall 2 DAILY ORAL / 2.5 MG DAILY ORAL 1 15 DAY .. SS .. SS .. SS Potassium C Synthroid C Atenolol C Pericolace C Cardilate C Date:07/02/98ISR Number: 3101028-4Report Type:Expedited (15-DaCompany Report #YOSJA-39475 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Pain Foreign Risperdal PS Janssen ORAL 4 MG DAILY Initial or Prolonged Cellulitis Health ORAL Lactation Puerperal Professional Impromen SS Janssen ORAL 11 MG DAILY Increased ORAL Mastitis Contomin SS ORAL 100 MG DAILY Contomin SS ORAL 150 MG DAILY ORAL 23 MON Levotomin SS ORAL 10 MG DAILY ORAL 23 MON Date:07/02/98ISR Number: 3108724-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypertension Risperdal PS Janssen ORAL 3MG BID ORAL Oedema Valproic Acid SS Uol/Scherer ORAL 500MG 8 & 12 Weight Increased N; 750 MG QHS ORAL Aldactone C Date:07/02/98ISR Number: 3108728-0Report Type:Direct Company Report # Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complex Partial Seizures Risperidone PS ORAL 2MG PO BID Initial or Prolonged Depressed Level Of Consciousness Staring Tardive Dyskinesia Date:07/06/98ISR Number: 3102122-4Report Type:Expedited (15-DaCompany Report #JAFRA-39784 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Death Cardiogenic Shock Foreign Cyanosis Health 22-Feb-2006 08:20 AM Page: 286 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal (Risperidone), Tablet PS Janssen ORAL 12 MG DAILY ORAL Nozinan (Levomepromazine) C Hydrate De Chloral (Chloral-Hydrate) C Date:07/06/98ISR Number: 3102123-6Report Type:Expedited (15-DaCompany Report #JAFRA-39785 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Health (Risperidone), Professional Tablet PS Janssen ORAL 12 MG DAILY ORAL Nozinan (Levomepromazine) C Hydrate De Chloral (Chloral-Hydrate) C Date:07/09/98ISR Number: 3108953-9Report Type:Direct Company Report # Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Risperdal PS 2 MG BID PO 1 MON Flomax C Accupril C Norvasc C Furosemide C Date:07/09/98ISR Number: 3108956-4Report Type:Direct Company Report # Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Risperdal PS ORAL 0.5 MG PO BID 3 MON Flomax C Pepcid C Cardizem C Paxil C Fe So4 C Vitamin C C Propulsid C Tegretol C Date:07/09/98ISR Number: 3185119-8Report Type:Periodic Company Report #JAUSA-31997 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Disorder Health Risperdal Professional (Risperidone), Janssen, Solution PS Janssen ORAL 2.5 MG DAILY ORAL 5 22-Feb-2006 08:20 AM Page: 287 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report TEASPOON DAILY Restoril C Zolft C Vitamins C Date:07/09/98ISR Number: 3185124-1Report Type:Periodic Company Report #JAUSA-32202 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Consumer Risperdal (Risperidone), Janssen, Solution 1 Mg/Ml PS Janssen ORAL 1.5 MG DAILY ORAL (1 MG IN AM, 0.5 MG AT BEDTIME) Motrin C Theophylline C Date:07/09/98ISR Number: 3185129-0Report Type:Periodic Company Report #JAUSA-32208 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Risperdal (Risperidone), Janssen, Solution PS Janssen ORAL ORAL Artane C Date:07/09/98ISR Number: 3185131-9Report Type:Periodic Company Report #JAUSA-32222 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal Initial or Prolonged Drug Abuser Professional (Risperidone), Sedation Janssen, Solution PS Janssen ORAL 5 ML 2 DAILY Supraventricular ORAL Tachycardia Ritalin C Clonidine C Date:07/09/98ISR Number: 3185133-2Report Type:Periodic Company Report #JAUSA-32425 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Health Risperdal Professional (Risperidone), Janssen, Solution PS Janssen ORAL .3 MG DAILY ORAL; 2.5 MG DAILY ORAL Haldol C Tegretol C Klolnopin C Trazodone C 22-Feb-2006 08:20 AM Page: 288 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/98ISR Number: 3185136-8Report Type:Periodic Company Report #JAUSA-32705 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Risperdal Initial or Prolonged Malaise Professional (Risperidone), Sedation Janssen, Solution PS Janssen ORAL .1 MG 1 DAILY Stupor ORAL SOLUTION Trazodone C Buspar C Zoloft C Date:07/09/98ISR Number: 3185139-3Report Type:Periodic Company Report #JAUSA-32895 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Health Risperdal Life-Threatening Neuroleptic Malignant Professional (Risperidone), Hospitalization - Syndrome Janssen, Solution PS Janssen ORAL 2 ML SINGLE Initial or Prolonged Rhabdomyolysis ORAL Stupor Haldol (Haloperidol), Janssen, Tablet SS Janssen ORAL SINGLE ORAL Benadryl C Pen-Vee K C Erythromycin C Date:07/13/98ISR Number: 3105083-7Report Type:Expedited (15-DaCompany Report #980707-008012397 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Foreign Haloperidol PS ORAL 2 MG, QD, Initial or Prolonged Hallucination, Auditory Health ORAL Suicide Attempt Professional Risperidone SS ORAL 2 MG, QD, ORAL Date:07/13/98ISR Number: 3105332-5Report Type:Expedited (15-DaCompany Report #JAUSA-33244 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Risperdal PS Janssen ORAL 4 MG 2 DAILY Diabetic Ketoacidosis Professional ORAL Weight Increased Prolixin C Cogentin C Depakene C Ibuprofen C Colace C Ativan C Date:07/13/98ISR Number: 3105333-7Report Type:Expedited (15-DaCompany Report #JAGER-39837 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chest Pain Foreign Risperdal PS Janssen ORAL 4 MG DAILY Hospitalization - Condition Aggravated Health ORAL Initial or Prolonged Pleural Effusion Professional Melleril SS ORAL 150 MG DAILY, Pulmonary Embolism ORAL Cipramil C 22-Feb-2006 08:20 AM Page: 289 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dytide H C L-Thyroxin C Date:07/13/98ISR Number: 3105334-9Report Type:Expedited (15-DaCompany Report #JAGER-39534 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Foreign Risperdal PS Janssen ORAL 6 MG DAILY, Initial or Prolonged Blood Creatine Health ORAL Phosphokinase Increased Professional Dociton C Gastrointestinal Gastrozepin C Infection Lasix C Pyrexia Rhabdomyolysis Date:07/13/98ISR Number: 3105335-0Report Type:Expedited (15-DaCompany Report #JAKYO-39553 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Risperidone PS Janssen ORAL 4 MG DAILY Cardiac Failure Health ORAL Condition Aggravated Professional Clocapramine C Hepatic Function Abnormal Mosapramine C Neuroleptic Malignant Brotizolam C Syndrome Nitrazepam C Renal Impairment Senna Extract C Rhabdomyolysis Promethazine C Sedation Polyenephosphatidylc Sinus Tachycardia holine C Magnesium Oxide C Protoporphyrin C Epinephrine C Dopamine C Dobutamine C Unspecified C Date:07/13/98ISR Number: 3108259-8Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chills Riseperdal PS UNKNOWN UNKNOWN Dermatitis Exfoliative Vistaril C Pyrexia Rash Pruritic Date:07/14/98ISR Number: 3108192-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Movement Disorder Clozapine PS Novartis ORAL 300 MG BID PO Resperidone SS Janssen ORAL 1 MG BID PO 22-Feb-2006 08:20 AM Page: 290 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/98ISR Number: 3108194-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Movement Disorder Risperidone PS Rousseau ORAL 2 MG BID PO Date:07/15/98ISR Number: 3105558-0Report Type:Expedited (15-DaCompany Report #JAGER-39845 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Foreign Risperdal PS Janssen ORAL 6 MG DAILY Initial or Prolonged Neck Pain ORAL; 4 MG Neutropenia DAILY ORAL;3 Pyrexia MG DAILY Rhinitis ORAL; SEE 9 DAY Leponex (Clozapine) C 15 DAY N/A C N/A C N/A C Date:07/15/98ISR Number: 3105560-9Report Type:Expedited (15-DaCompany Report #JAUSA-32885 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Risperdal PS Janssen ORAL 3 MG 1 DAILY Professional ORAL 8 WK Date:07/15/98ISR Number: 3105562-2Report Type:Expedited (15-DaCompany Report #JAUSA-33361 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Macrocytic Health Risperdal PS Janssen ORAL ORAL 3 MON Initial or Prolonged Bone Marrow Depression Professional Leukopenia Pancytopenia Pyrexia Sepsis Date:07/15/98ISR Number: 3105564-6Report Type:Expedited (15-DaCompany Report #JAFRA-39785 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Mania Foreign Risperdal PS Janssen ORAL 10 MG DAILY Hospitalization - Vasodilatation Health ORAL; 12 MG Initial or Prolonged Professional DAILY ORAL 8 WK Haldol Decanoas (Haloperidone) Solution SS INTRAMUSCULAR 300 MG 3 WEEKLY INTRAMUSCULAR Nozinan (Levomepromazine) SS ORAL 300 MG DAILY ORAL 14 MON Hydrate De Chloral (Chloral-Hydrate) Syrup SS ORAL SINGLE ORAL 2 SOUP SPOONS Depamide 22-Feb-2006 08:20 AM Page: 291 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Valpromide) SS ORAL 30 MG DAILY ORAL; 600 MG DAILY ORAL Theralene (Alimemazine) Solution SS ORAL SINGLE ORAL 100 DROPS Theralite (Lithium) SS ORAL DAILY ORAL, 5 CAPSULES/DAY 14 MON Date:07/15/98ISR Number: 3105566-XReport Type:Expedited (15-DaCompany Report #JAFRA-39784 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bundle Branch Block Right Foreign Risperdal PS Janssen ORAL 6 MG DAILY Hospitalization - Cardiogenic Shock Health ORAL; 16 MG Initial or Prolonged Condition Aggravated Professional DAILY ORAL 6 DAY Cyanosis Nozinan SS ORAL 600 MG Gamma-Glutamyltransferase DAILYORAL Increased Gardenal SS ORAL 100 MG 1 Hypertension DAILY ORAL Hyponatraemia Depamide SS ORAL 600 MG DAILY Mouth Haemorrhage ORAL; 3 DAILY Psychotic Disorder ORAL 60 DAY Pulmonary Oedema Rohypnol SS 2 MG 1 DAILY ORAL 6 DAY Theralene Solution SS ORAL 150 MG DAILY ORAL, 150 DROPS/DAY 6 DAY Melleril SS ORAL 200 MG 1 DAILY ORAL 5 DAY Renitec SS ORAL 20 MG 1 DAILY ORAL 10 MON Lepticur (Tropatepine) C Efferalgan Vitamine C (Efferalgan (R)) C Brufen (Ibuprofen) C Date:07/15/98ISR Number: 3105567-1Report Type:Expedited (15-DaCompany Report #JAKYO-39553 Age:47 YR Gender:Female I/FU:F Outcome PT Death Brain Oedema Cardiac Arrest Cardiac Index Abnormal Cardio-Respiratory Arrest Chest X-Ray Abnormal Crying Decreased Activity Depressed Level Of Consciousness Electrocardiogram Abnormal Electrocardiogram St Segment Depression Fall Hypopnoea Hypotension Intracranial Pressure 22-Feb-2006 08:20 AM Page: 292 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Miosis Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Oxygen Saturation Foreign Risperidone PS Janssen ORAL 4 MG DAILY Decreased Health ORAL Pupillary Reflex Impaired Professional Mosapramine SS ORAL 75 MG DAILY Renal Failure ORAL Rhabdomyolysis Clocapramine C Sinus Tachycardia Brotizolam C Ventricular Fibrillation Nitrazepam C Senna Extract C Promethazine C Polyenephosphatidych oline C Magnesium Oxide C Protoporhyrin C Epinephrine C Dopamine C Dobutamine C Date:07/15/98ISR Number: 3105568-3Report Type:Expedited (15-DaCompany Report #JAUSA-32270 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Health Risperdal PS Janssen ORAL .5 MG DAILY Abdominal Tenderness Professional ORAL,TAKEN AT Arrhythmia HS, HALF A Asthenia TABLET Blood Cortisol Increased Klonopin C Breath Sounds Abnormal Paxil C Excoriation Fall Grand Mal Convulsion Hallucination, Auditory Hypotension Hypovolaemic Shock Labile Blood Pressure Nausea Pulse Absent Staring Ventricular Hypertrophy Date:07/16/98ISR Number: 3105882-1Report Type:Expedited (15-DaCompany Report #980710-008012494 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Haloperidol PS ORAL 10 MG, QD, Erectile Dysfunction Health ORAL Poisoning Deliberate Professional Risperidone SS ORAL 2 MG, QD, Thinking Abnormal ORAL Haloperidol Decanoate SS INTRAMUSCULAR 50 MG, QD, IM (INTRAMUSCULA R) Risperidone SS ORAL 4 MG, QD, ORAL Risperidone SS ORAL 6 MG, QD, ORAL Chlorprothixene C 22-Feb-2006 08:20 AM Page: 293 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Biperiden C Date:07/17/98ISR Number: 3106328-XReport Type:Expedited (15-DaCompany Report #JAUSA-33496 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Health Risperdal PS ORAL ORAL Initial or Prolonged Coma Professional Infection Laceration Leukocytosis Pyrexia Date:07/17/98ISR Number: 3108214-8Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Risperdiol PS Coma Difficulty In Walking Feeding Disorder Insomnia Loss Of Consciousness Mastication Disorder Restlessness Sedation Speech Disorder Thinking Abnormal Urinary Incontinence Date:07/20/98ISR Number: 3107080-4Report Type:Expedited (15-DaCompany Report #JAFRA-39858 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Colitis Foreign Risperdal PS ORAL 8 MG DAILY Hospitalization - Diarrhoea Health ORAL Initial or Prolonged Gastroenteritis Professional Antibiotherapie C Aerobacter Large Intestinal Ulcer Sepsis Date:07/23/98ISR Number: 3109290-9Report Type:Expedited (15-DaCompany Report #JAUSA-33506 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Distress Health Risperdal PS Janssen ORAL Initial or Prolonged Professional Date:07/23/98ISR Number: 3109292-2Report Type:Expedited (15-DaCompany Report #JAFRA-39660 Age:27 YR Gender:Female I/FU:I Outcome PT Hospitalization - Conjunctival Hyperaemia Initial or Prolonged Conjunctivitis Eye Pain Lacrimation Increased 22-Feb-2006 08:20 AM Page: 294 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myasthenic Syndrome Scleritis Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal PS Janssen ORAL 6 MG DAILY Health Tercian Professional (Cyamemazine) C Imovance (Zopiclone) C Xanax (Alprazolam) C Hept-A-Myl (Heptaminol) C Date:07/23/98ISR Number: 3109294-6Report Type:Expedited (15-DaCompany Report #JAAUS-39909 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Ecchymosis Foreign Risperidone PS Janssen ORAL 1 MG 2 DAILY Haemorrhage Study Placebo SS ORAL 2 DAILY Health Professional Date:07/23/98ISR Number: 3109296-XReport Type:Expedited (15-DaCompany Report #JAGER-39845 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Foreign Risperdal Initial or Prolonged Neck Pain (Risperidone), Neutropenia Janssen, Tablet PS Janssen ORAL 6 MG DAILY Pyrexia Leponex (Clozapine) C Rhinitis Date:07/27/98ISR Number: 3109675-0Report Type:Direct Company Report # Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Thrombocytopenia Risperidone PS ORAL 0.25 MG TID PO Zosyn SS INTRAVENOUS 3.375 Q8 IV Date:07/27/98ISR Number: 3110110-7Report Type:Expedited (15-DaCompany Report #JAFRA-37621 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Risperdal PS Janssen ORAL 2 MG 2 DAILY Initial or Prolonged Increased Health Haldol SS Janssen ORAL 12 MG DAILY Disability Blood Creatine Professional Phosphokinase Increased Cachexia Cerebellar Syndrome Diarrhoea Hepatocellular Damage Hypoglycaemia Malaise Mutism Neuroleptic Malignant Syndrome Pyrexia Thrombocytopenia 22-Feb-2006 08:20 AM Page: 295 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/98ISR Number: 3110111-9Report Type:Expedited (15-DaCompany Report #JAKYO-39917 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Risperidone PS Janssen ORAL 3 MG DAILY 2 YR Bundle Branch Block Left Health Haloperidol Professional (Haloeridol) C Pimozide (Pimozide) C Sulpiride (Sulpiride) C Date:07/31/98ISR Number: 3111328-XReport Type:Expedited (15-DaCompany Report #JAAUS-39909 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Foreign Risperidone PS Janssen ORAL 1MG 2 DAILY Ecchymosis Study ORAL Fall Health Placebo SS ORAL -, 2 DAILY Gait Disturbance Professional ORAL Haemorrhagic Stroke Date:07/31/98ISR Number: 3111329-1Report Type:Expedited (15-DaCompany Report #JAUSA-33734 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eye Rolling Health Risperdal PS Janssen ORAL -, ORAL Initial or Prolonged Professional Ativan C Pproventil C Atrovent C Klonopin C Prozac C Macrobid C Theophylline C Ensure C Date:07/31/98ISR Number: 3111632-5Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Risperidone PS ORAL 2MG BID, ORAL Isosorbide Dinitrate C Multivitamin C Furosemide C Potassium Chloride C Famotidine C Albuterol C Ipratropium Bromide C Valproic Acid C Naproxen C Nitroglycerin C Nicotrol C Carisoprodol C 22-Feb-2006 08:20 AM Page: 296 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/98ISR Number: 3116527-9Report Type:Expedited (15-DaCompany Report #M0374-98 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Remeron PS ORAL 15 MG/DAY PO Initial or Prolonged Drug Interaction Professional Risperdal SS Pneumonia Date:07/31/98ISR Number: 3155686-9Report Type:Periodic Company Report #8-97192-003R Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Pondimin PS ORAL 20 MG THREE Oedema Peripheral Professional TIMES DAILY ORAL Fastin SS ORAL 30 MG DAILY (1 TABLET 2 HRS AFTER BREAKFAST) ORAL Risperdal SS 2 MG EVERY DAY Prozac C 40 MG ONCE DAILY 7 YR Klonopin C Lasix C Risperda C Soma C Tegretol C Date:08/03/98ISR Number: 3155236-7Report Type:Periodic Company Report #8-98035-008J Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Consumer Pondimin PS ORAL 20 MG TWICE Skin Disorder DAILY ORAL Tachycardia Phentermine SS ORAL 30 MG DAILY ORAL Risperdal SS Potassium C Date:08/05/98ISR Number: 3113462-7Report Type:Expedited (15-DaCompany Report #JACAN-16833 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Above Foreign Risperdal PS Janssen ORAL ORAL Initial or Prolonged Therapeutic Health Lithium C Professional Date:08/06/98ISR Number: 3113697-3Report Type:Direct Company Report # Age:13 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Risperdal PS ORAL 1 MG PO 22-Feb-2006 08:20 AM Page: 297 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/10/98ISR Number: 3114787-1Report Type:Expedited (15-DaCompany Report #JAUK-40064 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Foreign Risperidone PS Janssen ORAL 6 MG DAILY Congestive ORAL Dyspnoea Procyclidine C Pulmonary Oedema Paroxetine C Diazepam C Trifluoperazine C Date:08/10/98ISR Number: 3114788-3Report Type:Expedited (15-DaCompany Report #JAUK-40062 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperidone PS Janssen ORAL 2 MG DAILY Initial or Prolonged Electrocardiogram Qt ORAL Prolonged Olanzapine C Hypotension Date:08/10/98ISR Number: 3114789-5Report Type:Expedited (15-DaCompany Report #JAAUT-40053 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myoglobinuria Foreign Risperdal PS Janssen ORAL 2 MG 3 DAILY Initial or Prolonged ORAL Date:08/10/98ISR Number: 3114790-1Report Type:Expedited (15-DaCompany Report #JAAUS-39909 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Ecchymosis Foreign Risperidone PS Janssen ORAL 1 MG 2 DAILY Fall Study ORAL Gait Disturbance Health Placebo SS ORAL -, 2 DAILY Haemorrhagic Stroke Professional ORAL Date:08/13/98ISR Number: 3116525-5Report Type:Expedited (15-DaCompany Report #M0372-98 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Health Remeron PS ORAL 30 MG/DAY PO Initial or Prolonged Deep Vein Thrombosis Professional Risperdal SS Drug Interaction Oedema Peripheral Date:08/13/98ISR Number: 3116526-7Report Type:Expedited (15-DaCompany Report #M0373-98 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Remeron PS ORAL 15 MG PO Initial or Prolonged Drug Interaction Professional Risperdal SS Pulmonary Embolism 22-Feb-2006 08:20 AM Page: 298 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/14/98ISR Number: 3116895-8Report Type:Expedited (15-DaCompany Report #JAUSA-33916 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Amylase Increased Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Blood Creatine Professional ORAL Phosphokinase Increased (12/13/97 - Blood Creatinine 07/08/98); 2 Increased MG 2 DAILY Blood Glucose Increased Microzide SS Blood Potassium Decreased Wellbutrin Electrocardiogram (Amfebutamone) C Abnormal Azmacort Haematuria (Triamcinolone) C Palpitations Albuterol Proteinuria (Salbutamol) C Sinus Arrhythmia Peridex Sinus Bradycardia (Chlorhexidine) C Zextril (Lisinopril) C Date:08/14/98ISR Number: 3117003-XReport Type:Direct Company Report # Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Risperdal PS ORAL 1MG PO BID 3 DAY Required Gait Disturbance Intervention to Muscle Rigidity Prevent Permanent Parkinsonism Impairment/Damage Tremor Date:08/14/98ISR Number: 3117005-3Report Type:Direct Company Report # Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyspnoea Risperdal PS ORAL 2MG PO 15 WK Intervention to Dystonia Prevent Permanent Tongue Oedema Impairment/Damage Date:08/14/98ISR Number: 3117007-7Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Risperdol PS ORAL 1MG QD PO 6 DAY Required Confusional State Mesoridazine SS ORAL 500MG PO BID Intervention to Disorientation Amantadine SS ORAL 100MG PO QD Prevent Permanent Impairment/Damage Date:08/14/98ISR Number: 3117016-8Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Risperdal PS Janssen ORAL 3MG PO BID Hospitalization - Phosphokinase Increased Haloperidol SS INTRAMUSCULAR 5MG POOR IM Q Initial or Prolonged Body Temperature B' PRN Increased Muscle Rigidity 22-Feb-2006 08:20 AM Page: 299 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/14/98ISR Number: 3117018-1Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysarthria Risperdol PS ORAL 1MG PO QD 3 MON Gait Disturbance Date:08/17/98ISR Number: 3118028-0Report Type:Expedited (15-DaCompany Report #JAUSA-33982 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Consumer Risperdal PS Janssen ORAL 1 MG ; 2 Hospitalization - Colour Blindness DAILY; ORAL Initial or Prolonged Confusional State Navane C Conjunctivitis Amantadine C Convulsion Difficulty In Walking Dysarthria Ecchymosis Lacrimation Increased Lethargy Memory Impairment Muscle Rigidity Nasal Congestion Ocular Hyperaemia Pneumonia Urinary Retention Urinary Tract Infection Date:08/17/98ISR Number: 3118030-9Report Type:Expedited (15-DaCompany Report #JAUSA-33361 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Macrocytic Health Risperdal PS Janssen ORAL ORAL 3 MON Initial or Prolonged Bone Marrow Depression Professional Vitamins C Cardiac Failure High Effexor C Output Pilocarpine C Cholelithiasis Serax C Hydronephrosis Leukopenia Myeloid Metaplasia Pancytopenia Pyrexia Sepsis Date:08/17/98ISR Number: 3118336-3Report Type:Expedited (15-DaCompany Report #JAKYO-39553 Age:47 YR Gender:Female I/FU:F Outcome PT Death Brain Oedema Cardio-Respiratory Arrest Crying Electrocardiogram St Segment Depression Fall Intracranial Pressure Increased Mydriasis Neuroleptic Malignant 22-Feb-2006 08:20 AM Page: 300 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Renal Impairment Rhabdomyolysis Sinus Tachycardia Report Source Product Role Manufacturer Route Dose Duration Ventricular Fibrillation Foreign Risperidone PS Janssen ORAL 4 MG DAILY Health ORAL Professional Mosapramine SS ORAL 75 MG DAILY ORAL Clocapramine C Brotizolam C Nitrazepam C Senna Extract C Promethazine C Polyenephosphatidylc holine C Magnesium Oxide C Protoporphyrin C Epinephrine C Dopamine C Dobutamine C Date:08/18/98ISR Number: 3117876-0Report Type:Expedited (15-DaCompany Report #8-98216-010A Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Seresta PS ORAL 10 MG DAILY Initial or Prolonged Hypertonia Health ORAL Other Professional Deroxat (Paroxetine) SS ORAL 10 MG DAILY ORAL Tranxene (Potassium Clorazepate) Capsules SS ORAL 5 MG DAILY ORAL Risperdal (Risperidone) SS ORAL 1 MG DAILY ORAL Deroxat (Paroxetine) C Risperdal (Risperidone) C Tranxene (Potassiumm Clorazepate) C Date:08/19/98ISR Number: 3118734-8Report Type:Expedited (15-DaCompany Report #DEU000686 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaphylactic Shock Foreign Akineton PS ORAL 3MG DAILY PO Initial or Prolonged Hepatic Function Abnormal Other Akineton SS ORAL 6MG DAILY PO Liver Function Test Rohypnol SS ORAL 2MG DAILY PO Abnormal Mellax SS ORAL 2MG DAILY PO Emilace SS ORAL 60MG DAILY PO Benzalin SS ORAL 5MG DAILY PO Risperdal SS ORAL 3MG DAILY PO Flunitrazepam C Ethyl Loflazepate C Nemonapride C Nitrazepam C Risperidone C Mosapramine C Tetramide C 22-Feb-2006 08:20 AM Page: 301 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rohypnol C Melleril C Dogmatyl C Cremin C Date:08/19/98ISR Number: 3118790-7Report Type:Expedited (15-DaCompany Report #JAKYO-40149 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Risperidone PS Janssen ORAL 2 MG DAILY Health ORAL Professional Propericiazine C Date:08/19/98ISR Number: 3118792-0Report Type:Expedited (15-DaCompany Report #JACAN-16858 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Exhaustion Foreign Risperidone PS Janssen ORAL 4 MG 2 DAILY Heat Stroke Consumer ORAL Ranitidine SS ORAL 150 MG 1 DAILY ORAL Benztropine C Clonazepam C Date:08/19/98ISR Number: 3118794-4Report Type:Expedited (15-DaCompany Report #JAKYO-40153 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Pain Foreign Risperidone PS Janssen ORAL 4 MG DAILY Initial or Prolonged Cellulitis Health ORAL Lactation Puerperal Professional Bromperidol SS Janssen ORAL DAILY, ORAL Increased Chlorpromazine SS ORAL 150 MG DAILY 23 MON Mastitis Levomepromazine SS ORAL 10 MG DAILY 23 MON Date:08/19/98ISR Number: 3119045-7Report Type:Expedited (15-DaCompany Report #JAUSA-25236 Age:42 YR Gender:Male I/FU:F Outcome PT Other Abdominal Distension Abdominal Pain Amnesia Aneurysm Blood Cholesterol Increased Blood Glucose Increased Blood Pressure Increased Blood Triglycerides Increased Cardiac Aneurysm Chest Pain Circulatory Collapse Cyanosis Dermatitis Dizziness Drooling Dyskinesia Dyspnoea 22-Feb-2006 08:20 AM Page: 302 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ear Discomfort Ecchymosis Electrocardiogram Qt Report Source Product Role Manufacturer Route Dose Duration Prolonged Consumer Risperdal PS Janssen ORAL 1 MG 2 DAILY Embolism ORAL\2 MG Fatigue DAILY\3 MG 2 Gingival Bleeding DAILY\4 MG 2 Head Injury DAILY\2 MG 2 22 WK Headache Pravachol C Hearing Impaired Selenium C Heart Rate Irregular Lotrisone Cream C Hypertension Niacin C Hypoaesthesia Vitamin E C Liver Disorder Tyenol C Liver Function Test Ibruprofen C Abnormal Fish Oil Concentrate C Memory Impairment Maalox C Muscle Rigidity Nausea Oedema Peripheral Embolism Pharyngeal Haemorrhage Psychomotor Retardation Skin Discolouration Testicular Disorder Testicular Pain Tooth Disorder Visual Acuity Reduced Weight Increased Date:08/19/98ISR Number: 3119047-0Report Type:Expedited (15-DaCompany Report #JAUSA-33061 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Hypotension Professional ORAL Hypothermia Synthroid C Pancytopenia Zantac C Cipro C Unasyn C Date:08/21/98ISR Number: 3120396-0Report Type:Expedited (15-DaCompany Report #JAUSA-34024 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal PS ORAL 4 MG 1 DAILY Neutropenia Professional ORAL Tuberculosis Isoniazide SS 300 MG White Blood Cell Count Pyrazinamide C Decreased Zantac C Vitamin B-6 C Date:08/24/98ISR Number: 3121401-8Report Type:Expedited (15-DaCompany Report #JAFRA-39936 Age: Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Pyrexia Foreign Initial or Prolonged Urinary Tract Infection Health 22-Feb-2006 08:20 AM Page: 303 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal PS Janssen ORAL 2 MG DAILY; ORAL Date:08/25/98ISR Number: 3121398-0Report Type:Expedited (15-DaCompany Report #JAUSA-34083 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disseminated Health Risperdal PS Janssen ORAL 1 MG 2 DAILY; Intravascular Coagulation Professional ORAL ; 3 Hypotension DOSES Neutrophil Count Tamoxifen C Increased Tegretol C Oliguria Tomoptic (-) C White Blood Cell Count Increased Date:08/26/98ISR Number: 3121995-2Report Type:Expedited (15-DaCompany Report #JAUSA-34068 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomegaly Health Risperdal PS Janssen ORAL ORAL 3 YR Initial or Prolonged Dyspnoea Professional Thiazide C Pleural Effusion Zoloft (Sertraline) C Date:08/26/98ISR Number: 3121999-XReport Type:Expedited (15-DaCompany Report #JAFRA-39059 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Riperdal PS Janssen ORAL DAILY ORAL Health Teralithe (Lithium) C Professional Xanax (Alprazolam) C Tercian (Cyamemazine) C Dysport (Clostridium Botulinum Toxin Type A) C Ivadal (Zolpidem) C Date:08/27/98ISR Number: 3122628-1Report Type:Expedited (15-DaCompany Report #M072939 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Other Stadol Nasal Spray PS NASAL 1 BOTTLE Q2D Initial or Prolonged Decreased Appetite NASAL SP 5 YR Disability Depression Demerol SS 3 YR Drug Dependence Lorcet SS 3 YR Drug Withdrawal Syndrome Risperdal SS 3 YR Dysarthria Marijuana SS 3 YR Insomnia Alcohol C Weight Decreased Valium C Xanax C Norplant C 22-Feb-2006 08:20 AM Page: 304 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/98ISR Number: 3123296-5Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Risperidone PS ORAL 2MG BID PO Blood Testosterone Increased Male Sexual Dysfunction Date:09/01/98ISR Number: 3124434-0Report Type:Direct Company Report # Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Risperdal PS 1 TAB BID Chronic Fatigue Syndrome EVERY OTHER Deafness THRU 3 YRS 3 YR Ear Pain Hypoaesthesia Insomnia Sensory Loss Tinnitus Date:09/01/98ISR Number: 3124720-4Report Type:Expedited (15-DaCompany Report #HOAFF-40193 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Disorder Foreign Risperidone PS Janssen ORAL ORAL 1 WK Initial or Prolonged Dysuria Literature Haloperidol Haematuria Health (Haloperidol) C Hydronephrosis Professional Haloperidol Inflammation (Haloperidol) C Necrosis Fluoxetine Pollakiuria (Fluoxetine) C Rhabdomyosarcoma Valproic Acid (Valproic Acid) C Benztropine (Benztropine) C Clonidine (Clonidine) C Trazodone (Trazodone) C Desmopressin (Desmoprssin) C Date:09/02/98ISR Number: 3126391-XReport Type:Direct Company Report # Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Depakote PS 250 MG TID Increased Zoloft SS 100 MG DAILY Blood Thyroid Stimulating Risperdal SS 4 MG QHS Hormone Increased Hypertriglyceridaemia 22-Feb-2006 08:20 AM Page: 305 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/04/98ISR Number: 3126339-8Report Type:Expedited (15-DaCompany Report #JAKYO-39818 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Risperidone PS Janssen ORAL 2 MG DAILY; Cardiac Arrest Health ORAL Condition Aggravated Professional Trihexyphenidyl C Eating Disorder Propericiazine C Injury Asphyxiation Nemonapride C Date:09/09/98ISR Number: 3126432-XReport Type:Expedited (15-DaCompany Report #JAKYO-40303 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Risperidone PS Janssen ORAL 1-2MG/DAY Blood Creatine Health ORAL Phosphokinase Increased Professional Hyperhidrosis Neuroleptic Malignant Syndrome Pyrexia Rhabdomyolysis Date:09/09/98ISR Number: 3126766-9Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Risperdal PS 2 MG BID Date:09/10/98ISR Number: 3127921-4Report Type:Expedited (15-DaCompany Report #JAUSA-34245 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Risperdal PS Janssen ORAL ORAL Initial or Prolonged Phosphokinase Increased Professional Cocaine SS Blood Creatinine Diphenhydramine SS Increased Blood Potassium Increased Chromaturia Coma Compartment Syndrome Depression Drug Abuser Fall Haematuria Injury Intentional Overdose Lethargy Myoglobinuria Oedema Peripheral Rhabdomyolysis Sedation Suicide Attempt 22-Feb-2006 08:20 AM Page: 306 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/10/98ISR Number: 3128395-XReport Type:Direct Company Report # Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypotension Risperidone PS ORAL PO Hospitalization - Respiratory Arrest Sular C Initial or Prolonged Lopressor C Required Intervention to Prevent Permanent Impairment/Damage Date:09/11/98ISR Number: 3128266-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Risperidone PS ORAL 1MG PO BID Tongue Disorder Date:09/11/98ISR Number: 3128343-2Report Type:Expedited (15-DaCompany Report #980904-008013267 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Haloperidol PS ORAL 9 MG, QD, Initial or Prolonged Hallucination, Auditory Health ORAL Supraventricular Professional Risperidone SS ORAL SEE IMAGE Extrasystoles Bromperidol SS ORAL 6 MG, QD, ORAL Chlorpromazine SS ORAL 75 MG, QD, ORAL Flunitrazepam C Biperiden Hydrochloride C Zonisamide C Pilsicainide Hydrochloride C Date:09/11/98ISR Number: 3128357-2Report Type:Expedited (15-DaCompany Report #980904-008013270 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Haldol PS Initial or Prolonged Syndrome Professional Risperidone SS ORAL ORAL Respiratory Depression Fluphenazine Hydrochloride SS Fluphenazine Decanoate SS INTRAMUSCULAR IM Date:09/11/98ISR Number: 3128361-4Report Type:Expedited (15-DaCompany Report #980908-008013291 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Haloperidol PS ORAL 4.5 MG, QD, Hospitalization - Bundle Branch Block Left Health ORAL Initial or Prolonged Electrocardiogram Professional Risperidone SS ORAL 3 MG, QD, Abnormal ORAL Sinus Arrhythmia Sulpiride SS ORAL 600 MG, QD, ORAL 22-Feb-2006 08:20 AM Page: 307 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report * C Mazaticol Hydrochloride C Pantethine C Clocapramine Hydrochloride C Pimozide C Date:09/12/98ISR Number: 3137955-1Report Type:Periodic Company Report #JAUSA-26498 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Risperdal Professional (Risperidone) Janssen, Tablet PS Janssen ORAL ORAL Effexor (Venlafexine) SS ORAL 150 MG DAILY ORAL 2 MON Date:09/14/98ISR Number: 3129146-5Report Type:Expedited (15-DaCompany Report #JAKYO-39917 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Risperidone PS Janssen ORAL 3 MG DAILY Bundle Branch Block Left Health ORAL Condition Aggravated Professional Haloperidol SS Janssen ORAL 4.5 MG DAILY Electrocardiogram Delta ORAL Waves Abnormal Sulpiride SS ORAL 600 MG DAILY Sinus Arrhythmia ORAL 5 YR Pimozide (Pimozide) C Mazaticol (Mazaticol) C Pantethine (Pantethine) C Date:09/17/98ISR Number: 3131956-5Report Type:Expedited (15-DaCompany Report #JAFRA-40439 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Foreign Risperdal PS ORAL 1MG DAILY Health ORAL Professional Oflocet C Nitriderm C Stilnox C Date:09/18/98ISR Number: 3132248-0Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyponatraemia Risperidone PS ORAL 1 MG PO BID Risperidone SS ORAL 1 MG 96 HOURS PRN, 2 MG PO BID 22-Feb-2006 08:20 AM Page: 308 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/18/98ISR Number: 3132804-XReport Type:Expedited (15-DaCompany Report #JAFRA-40440 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Abortion Spontaneous Foreign Risperda PS Jassen ORAL DAILY, ORAL Complications Of Maternal Health Risperdal SS INTRA-UTERINE 2 MG LATER Exposure To Therapeutic Professional 6MG; END-DATE Drugs OF TREATMENT WAS ESTIMATED INTRAUTERINE Tercian C Imovane C Stilnox C Date:09/18/98ISR Number: 3132805-1Report Type:Expedited (15-DaCompany Report #JASWE-27997 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Risperidone PS Janssen ORAL .25 MG 2 Study DAILY ORAL Health Professional Date:09/18/98ISR Number: 3132842-7Report Type:Expedited (15-DaCompany Report #JAKYO-40473 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Risperidone PS Janssen ORAL INTRAUTERINE, Initial or Prolonged Exposure To Therapeutic Health ORAL Drugs Professional Flunitrazepam SS Janssen ORAL INTRAUTERINE, Irritability ORAL Transient Tachypnoea Of Clomipramine SS ORAL INTRAUTERINE, The Newborn ORAL Date:09/24/98ISR Number: 3134653-5Report Type:Expedited (15-DaCompany Report #9828633 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aggression Consumer Zoloft PS ORAL 100.00 MG Intervention to Alopecia TOTAL:DAILY:O Prevent Permanent Anger RAL Impairment/Damage Condition Aggravated Depakote SS ORAL ORAL Hepatitis Risperdal SS ORAL ORAL Intentional Self-Injury Tegretol SS ORAL ORAL Movement Disorder Obsessive-Compulsive Disorder Psychomotor Hyperactivity Pupil Fixed Tourette'S Disorder Date:09/24/98ISR Number: 3134884-4Report Type:Expedited (15-DaCompany Report #8-98260-022A Age:20 YR Gender:Female I/FU:I Outcome PT Hospitalization - Depressed Level Of Initial or Prolonged Consciousness Other Hallucination 22-Feb-2006 08:20 AM Page: 309 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Increased Hyperreflexia Hypoglycaemia Report Source Product Role Manufacturer Route Dose Duration Intentional Overdose Foreign Efexor PS ORAL ORAL Loss Of Consciousness Health Buspar SS ORAL ORAL Oxygen Saturation Professional Propavan SS ORAL ORAL Decreased Risperdal SS ORAL ORAL Pneumonia Aspiration Stilnoct C Respiratory Depression Zopiclone C Date:09/24/98ISR Number: 3134964-3Report Type:Expedited (15-DaCompany Report #B041162 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Buspar PS ORAL ORAL 1 DAY Initial or Prolonged Consciousness Health Propavan SS ORAL ORAL 1 DAY Hallucination Professional Risperdal SS ORAL 2 MG ORAL Heart Rate Increased Effexor SS ORAL 37.5 MG-75 MG Hyperreflexia ORAL Hypoglycaemia Stilnoct SS ORAL 5 MG ORAL 1 DAY Intentional Overdose Loss Of Consciousness Pneumonia Aspiration Respiratory Depression Suicide Attempt Date:09/28/98ISR Number: 3135868-2Report Type:Expedited (15-DaCompany Report #9829037 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Thyroid Stimulating Health Zoloft PS ORAL 100.00 MG Initial or Prolonged Hormone Increased Professional TOTAL:DAILY:O Hypercholesterolaemia RAL Hypertriglyceridaemia Depakote SS UNKNOWN 750.00 MG TOTAL:TID Risperidal SS UNKNOWN 4.00 MG TOTAL:DAILY Date:09/28/98ISR Number: 3136064-5Report Type:Expedited (15-DaCompany Report #JAUSA-25236 Age:42 YR Gender:Male I/FU:F Outcome PT Other Abdominal Distension Abdominal Pain Amnesia Aneurysm Blood Glucose Increased Blood Pressure Increased Cardiac Aneurysm Chest Pain Circulatory Collapse Constipation Dermatitis Dizziness Drooling Dyskinesia Dyspnoea Ear Discomfort 22-Feb-2006 08:20 AM Page: 310 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ecchymosis Electrocardiogram Qt Prolonged Report Source Product Role Manufacturer Route Dose Duration Embolism Consumer Risperdal PS Janssen ORAL 1MG 2 DAILY Fatigue ORAL Gingival Bleeding Pravachol C Haematemesis Selenium Sulfate C Head Injury Lotrisone Cream C Headache Niacin C Hearing Impaired Vitamin E C Heart Rate Increased Tylenol C Heart Rate Irregular Ibruprofen C Hypoaesthesia Fish Oil Concentrate C Hypothermia Maalox C Liver Function Test Abnormal Movement Disorder Muscle Rigidity Nausea Oedema Palpitations Skin Discolouration Testicular Disorder Testicular Pain Tooth Injury Toothache Urinary Incontinence Visual Acuity Reduced Weight Increased Date:09/29/98ISR Number: 3136522-3Report Type:Direct Company Report # Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypothermia Risperdal PS ORAL 4 MG BID 1 YR Pco2 Increased Date:09/29/98ISR Number: 3136527-2Report Type:Direct Company Report # Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Risperdal PS Initial or Prolonged Blood Pressure Diastolic Cogentin C Increased Depakote C Muscle Rigidity Neuroleptic Malignant Syndrome Urinary Incontinence Date:09/29/98ISR Number: 3136586-7Report Type:Direct Company Report # Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyskinesia Risperdil PS ORAL 1 MG PO BID 22-Feb-2006 08:20 AM Page: 311 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/30/98ISR Number: 3136972-5Report Type:Direct Company Report # Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Risperdal PS Initial or Prolonged Blood Pressure Decreased Other Body Temperature Decreased Coma Convulsion Dyskinesia Facial Palsy Hypothermia Respiratory Rate Decreased Date:09/30/98ISR Number: 3136974-9Report Type:Direct Company Report # Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Risperdal PS Initial or Prolonged Congestive Other Chronic Obstructive Pulmonary Disease Hypothermia Urinary Tract Infection Date:10/01/98ISR Number: 3137000-8Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Risperdal PS ORAL 3MG PO BID 30 DAY Dyspnoea Galactorrhoea Date:10/02/98ISR Number: 3137718-7Report Type:Expedited (15-DaCompany Report #JAKYO-40629 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Polydipsia Psychogenic Foreign Risperidone PS Janssen ORAL 3 MG DAILY Thirst Health ORAL Water Intoxication Professional Carpipramine C Vegetamin A(R) C Date:10/02/98ISR Number: 3137888-0Report Type:Expedited (15-DaCompany Report #JAUK-36451 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal PS Janssen ORAL ORAL Health Professional 22-Feb-2006 08:20 AM Page: 312 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/98ISR Number: 3137891-0Report Type:Expedited (15-DaCompany Report #JACOL-39714 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Risperidone PS Janssen ORAL ORAL Therapeutic Agent Health Toxicity Professional Date:10/05/98ISR Number: 3138327-6Report Type:Expedited (15-DaCompany Report #JAKYO-40670 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Risperidone PS Janssen ORAL 2 MG DAILY Neuroleptic Malignant Health ORAL Syndrome Professional Risperidone SS ORAL 4 MG DAILY Pneumonia ORAL Psychotic Disorder Haloperidol C Ubidecarenone C Biperiden Hydrochloride C Zotepine C Date:10/07/98ISR Number: 3139029-2Report Type:Direct Company Report # Age:86.5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Medication Error Risperdal PS 3 - 24 HRS Alprazolam SS Digoxin SS Date:10/07/98ISR Number: 3139071-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Risperdal PS Janssen 0.5 MG BID; INCREAED TO 1 MG BID Date:10/07/98ISR Number: 3139236-9Report Type:Expedited (15-DaCompany Report #YOSJA-40735 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Risamol PS ORAL 7.5 MG DAILY Cerebral Circulatory Health ORAL Failure Professional Risperidal SS ORAL 2 MG DAILY Dizziness ORAL Electrocardiogram St Tasmolin (Biperiden) C Segment Elevation Elen (Indeloxazine) C Hypertension Gaster (Famotidine) C Ileus Paralytic Selbex (Teprenone) C Loss Of Consciousness Rhythmy Pyrexia (Rilmazafone) C Supraventricular Hemocuron Extrasystoles (Tribenoside) C Transient Ischaemic Picoben (Sodium Attack Picosulfate) C Ventricular Extrasystoles Mucosta (Rebamipide) C Vomiting 22-Feb-2006 08:20 AM Page: 313 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/98ISR Number: 3140218-1Report Type:Expedited (15-DaCompany Report #JAUK-38785 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Foreign Risperdal PS Janssen ORAL 1 MG 2 DAILY Initial or Prolonged Dyspnoea Health ORAL Influenza Like Illness Professional Folic Acid C Lymphopenia Simple Linctus C Monocytosis Nasal Congestion Neutrophil Count Decreased Platelet Count Decreased Pyrexia White Blood Cell Count Decreased Date:10/08/98ISR Number: 3140347-2Report Type:Expedited (15-DaCompany Report #981005-008013816 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Haloperidol PS ORAL 1 MG BID ORAL Initial or Prolonged Increased Professional Risperidone SS ORAL .5 MG BID Haematuria ORAL/ 1 MG Kidney Infection BID ORAL Urinary Retention Valproate Sodium C Alprazolam C Sertraline C Olanzapine C Date:10/09/98ISR Number: 3140440-4Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Health Risperidone PS Janssen ORAL 1MG PO QD 1 MON Hospitalization - Blood Creatine Professional Initial or Prolonged Phosphokinase Increased Required Confusional State Intervention to Convulsion Prevent Permanent Difficulty In Walking Impairment/Damage Fear Pyrexia Tachycardia Tremor Urinary Incontinence Date:10/09/98ISR Number: 3141124-9Report Type:Expedited (15-DaCompany Report #JAUSA-34511 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Initial or Prolonged Haematuria Professional ORAL ; 1 MG 2 Kidney Infection DAILY ORAL Renal Failure Haldol SS Janssen ORAL 1 MG 2 DAILY Tremor ORAL Urinary Retention Depakote C Vesicoureteric Reflux Xanax C Zoloft C Zyprexa C 22-Feb-2006 08:20 AM Page: 314 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/98ISR Number: 3146563-8Report Type:Periodic Company Report #JAUSA-30397 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Consumer Risperdal Back Pain (Risperidone) Condition Aggravated Janssen, Tablet PS Janssen ORAL 1 MG DAILY Constipation ORAL Dizziness Zoloft C Eructation Synthroid C Hypothermia Estrace C Oedema Urinary Incontinence Urinary Tract Infection Date:10/12/98ISR Number: 3146571-7Report Type:Periodic Company Report #JAUSA-30399 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal (Risperidone) Janssen, Tablet PS Janssen ORAL 2 MG DAILY ORAL Lithium C Klonopin C Date:10/12/98ISR Number: 3148291-1Report Type:Periodic Company Report #JAUSA-29716 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Risperdal (Risperidone) Janssen Tablet PS Janssen ORAL 3MG 2 DAILY ORAL Wellbutrin C Date:10/13/98ISR Number: 3141338-8Report Type:Expedited (15-DaCompany Report #JAKYO-40157 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Risperidone PS Janssen ORAL 2 MG DAILY Abnormal Faeces Health ORAL/ 2 MG Anorexia Professional DAILY ORAL/ 1 Appendicitis MG DAILY Constipation ORAL; SEE 3 DAY Haematochezia Flunitrazepam C Ileus Paralytic Bulkosol C Pyrexia Simvastatin C Vomiting Magnesium Oxide C Date:10/13/98ISR Number: 3142367-0Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Risperdal PS ORAL 3 MG BID PO Disturbance In Attention Acetaminophen C Extrapyramidal Disorder Vitamin E C Benztropine C 22-Feb-2006 08:20 AM Page: 315 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/98ISR Number: 3142374-8Report Type:Expedited (15-DaCompany Report #981005-008013817 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Angioneurotic Oedema Foreign Haloperidol PS INTRAMUSCULAR TIW, IM, Oedema Peripheral Health (INTRAMUSCULA Psychiatric Symptom Professional R) Risperidone SS ORAL 1 TAB, QD, ORAL Inovane SS ORAL 3.75 MG, BID, ORAL Artane SS ORAL 10 MG.; QD; ORAL Lysanxia SS ORAL 40 MG; QD; ORAL Date:10/13/98ISR Number: 3267127-1Report Type:Periodic Company Report #JAUSA-33462 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epistaxis Health Risperdal Professional (Risperidone), Janssen, Solution 1 Mg/Ml PS Janssen ORAL .7 MG 1 DAILY ORAL COMMENTS: GIVEN AT BEDTIME; Date:10/13/98ISR Number: 3267132-5Report Type:Periodic Company Report #JAUSA-33472 Age:3 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Risperdal Professional (Risperidone), Janssen, Solution PS Janssen ORAL .5 MG 1 DAILY ORAL Date:10/13/98ISR Number: 3267135-0Report Type:Periodic Company Report #JAUSA-33525 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet 1 Mg/Ml PS Janssen ORAL 3 M 2 DAILY ORAL Clonazepam (Clonazepam) C Benztropine (Benztropine) C Date:10/13/98ISR Number: 3267140-4Report Type:Periodic Company Report #JAUSA-33875 Age:7 YR Gender:Male I/FU:I Outcome PT Other Drug Abuser Increased Appetite 22-Feb-2006 08:20 AM Page: 316 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Salivary Hypersecretion Sedation Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal (Risperidone), Janssen, Solution 1 Mg/Ml PS Janssen ORAL 2 ML 2 DAILY ORAL COMMENTS: ESTIMATED START DATE Date:10/13/98ISR Number: 3267144-1Report Type:Periodic Company Report #JAUSA-33928 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Consumer Risperdal Hallucination (Risperidone), Parkinsonism Janssen, Solution .5 Salivary Hypersecretion Mg PS Janssen ORAL .5 MG 2 DAILY ORAL Prozac (Fluoxetine) C Hytrin (Terazosin) C Amantadine (Amantadine) C Requip (Ropinirole) C Tylenol (Paracetamol) C Mom (Midecamycine) C Multivit (Multivit (R) ) C Vitam. B12 (Vitam. B12) C Vitamin E (Vitamin E) C Ritalin (Methylphenidate) C Date:10/13/98ISR Number: 3267149-0Report Type:Periodic Company Report #JAUSA-33939 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Palpitations Health Risperdal Tachycardia Professional (Risperidone), Janssen, Solution PS Janssen ORAL .25 MG ORAL; .5 MG ORAL Date:10/13/98ISR Number: 3267151-9Report Type:Periodic Company Report #JAUSA-34112 Age:5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Risperdal Chest Pain Professional (Risperidone), Dyskinesia Janssen, Solution PS Janssen ORAL .5 MG 2 DAILY Sedation ORAL Prozac (Fluoxetine) Solution SS ORAL 5 MG 1 DAILY ORAL 22-Feb-2006 08:20 AM Page: 317 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report COMMENTS: USED BEFORE CONVERSION TO 2 WK Date:10/13/98ISR Number: 3267153-2Report Type:Periodic Company Report #JAUSA-34251 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apnoea Consumer Risperdal (Risperidone), Janssen, Solution 1 Mg/Ml PS Janssen ORAL 2 MG 2 DAILY ORAL COMMENTS: ESTIMATED START DATE Date:10/13/98ISR Number: 3267159-3Report Type:Periodic Company Report #JAUSA-32895 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Health Risperdal Life-Threatening Neuroleptic Malignant Professional (Risperidone), Hospitalization - Syndrome Janssen, Solution PS ORAL 2 ML SINGLE Initial or Prolonged Rhabdomyolysis ORAL Stupor COMMENTS: ONE DOSE TAKEN IN P.M. Haldol (Haloperidol), Janssen, Tablet SS Janssen ORAL SINGLE ORAL; TAKEN ONCE PRIOR TO 11/12/97; PRESCRIPTION Prolixin (Fluphenazine) SS ORAL 5 MG 2 DAILY ORAL Benadryl (Diphenhydramine) C Pen-Vee K (Penicillin V Potassium) C Erythromycin (Erythromycin) C Date:10/14/98ISR Number: 3141381-9Report Type:Expedited (15-DaCompany Report #JAKYO-40808 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperidone PS Janssen ORAL 3 MG DAILY Initial or Prolonged Phosphokinase Increased Health ORAL Difficulty In Walking Professional Nifedipine C Myoglobinuria Pain In Extremity Rhabdomyolysis 22-Feb-2006 08:20 AM Page: 318 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/98ISR Number: 3142004-5Report Type:Expedited (15-DaCompany Report #JAKYO-40829 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperidone PS ORAL ORAL Initial or Prolonged Phosphokinase Increased Chromaturia Infection Pericarditis Pyrexia Date:10/15/98ISR Number: 3142005-7Report Type:Expedited (15-DaCompany Report #JAKYO-40670 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Risperidone PS ORAL 2 TO 4 MG Blood Pressure Decreased Health DAILY ORAL 9 WK Cachexia Professional Haloperidol C Cardiac Failure Ubidecarenone C Condition Aggravated Biperiden C Cough Zotepine C Cyanosis Flunitrazepam C Decreased Appetite Pantethine C Hyperhidrosis Neuroleptic Malignant Syndrome Pneumonia Productive Cough Psychotic Disorder Pyrexia Respiratory Failure Speech Disorder Upper Respiratory Tract Infection Date:10/15/98ISR Number: 3142453-5Report Type:Expedited (15-DaCompany Report #9832343 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Zoloft PS ORAL 50.00 MG Initial or Prolonged Drug Interaction Health TOTAL:DAILY:O Professional RAL Risperidone SS ORAL 2.00 MG TOTAL:BID:ORA L Nifedipine Xl C Indapamide C Metformin C Date:10/15/98ISR Number: 3142757-6Report Type:Direct Company Report # Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Risperidone PS ORAL 1 MG PO Q HS 6 MON Hallucination, Auditory Zoloft SS ORAL 50 MG PO Q Muscle Twitching AM01 1 YR Amantadine SS ORAL 100 MG PO Q HS 6 MON 22-Feb-2006 08:20 AM Page: 319 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/98ISR Number: 3143981-9Report Type:Direct Company Report # Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Decreased Ambien PS 15 MG HS Fall Klonopin SS 0.5 MG HS Mental Impairment Risperdal SS 0.5 MG BID Nausea Lithium Carbonate C Vomiting Date:10/16/98ISR Number: 3142802-8Report Type:Expedited (15-DaCompany Report #YOSJA-40735 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Risamol PS Janssen ORAL 7.5 MG DAILY Blood Pressure Increased Health ORAL ; 15 MG Cerebral Circulatory Professional DAILY ORAL 25 MON Failure Risperdal SS Janssen ORAL 2 MG DAILY Cerebral Ischaemia ORAL Dizziness Impromen SS ORAL 9 MG DAILY Electrocardiogram St ORAL 8 YR Segment Elevation Tasmolin C Ileus Paralytic Elen C Loss Of Consciousness Gaster C Pyrexia Selbex C Ventricular Extrasystoles Rhythmy C Vomiting Hemocuron C Picoben C Mucosta C Date:10/16/98ISR Number: 3143986-8Report Type:Direct Company Report # Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Risperdal PS Janssen Drooling Pharmaceutica Inc ORAL 1MG QD Dyskinesia Aricept C 10MG QD Dysphagia Aspirin Enteric Lethargy Coated C 81MG QD Tremor Metamucil C 1 TSP TID Depakote C 125MG TID Date:10/19/98ISR Number: 3143636-0Report Type:Expedited (15-DaCompany Report #HOAFF-40855 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Risperidone PS Janssen ORAL -, ORAL Dry Mouth Literature Ileus Paralytic Health Mydriasis Professional Overdose Sinus Tachycardia Supraventricular Tachycardia 22-Feb-2006 08:20 AM Page: 320 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/98ISR Number: 3143637-2Report Type:Expedited (15-DaCompany Report #HOAFF-40862 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Foreign Risperidone PS Janssen ORAL -, ORAL Distress Syndrome Literature Imipramine Coma Health (Imipramine) SS Electrocardiogram Qt Professional Benzitropine Prolonged Mesylate Hypotension (Benzitropine) C Overdose Ibuprofen Sepsis (Ibuprofen) C Tachycardia Date:10/19/98ISR Number: 3143638-4Report Type:Expedited (15-DaCompany Report #JAUK-38972 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Foreign Risperidone PS ORAL 2 MG 2 DAILY Bundle Branch Block Health ORAL Electrocardiogram St Professional Venlafaxine Segment Depression (Venlafaxine)- SS 37.5 MG 2 Oedema Peripheral DAILY Ventricular Hypertrophy Bendrofluazide (Bendroflumethiazide ) C Atenolol (Atenolol) C Digoxin (Digoxine) C Dothiepin (Dosulepine) C Aspirin (Acetylsalicylic-Aci d) C Date:10/19/98ISR Number: 3143639-6Report Type:Expedited (15-DaCompany Report #JAFRA-40475 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperdal PS Janssen ORAL ORAL Hospitalization - Coma Health Prothiaden Initial or Prolonged Electrocardiogram Qrs Professional (Dosulepine) SS Complex Prolonged Fall Malaise Mydriasis Sinus Bradycardia Date:10/19/98ISR Number: 3143640-2Report Type:Expedited (15-DaCompany Report #JAUSA-34330 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Health Risperdal PS ORAL 10 MG DAILY Dizziness Professional ORAL Hypertension Asa Myocardial Infarction (Acetylsalicylic-Aci d) C Artane (Trihexyphenidyl) C 22-Feb-2006 08:20 AM Page: 321 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/98ISR Number: 3143641-4Report Type:Expedited (15-DaCompany Report #JAKYO-40835 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malaise Foreign Risperidone PS Janssen ORAL ORAL Health Antipsychotics Unsp. Professional (Antipsychotics Unsp.) C Date:10/19/98ISR Number: 3143642-6Report Type:Expedited (15-DaCompany Report #JAUSA-33916 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Blood Creatine Professional ORAL; 2 MG 2 Phosphokinase Increased DAILY ORAL; 1 Blood Creatinine MG 2 DAILY Increased ORAL 28 DAY Condition Aggravated Microzide Electrocardiogram (Hydrochlorothiazide Abnormal )- SS Eyelid Function Disorder Wellbutrin Fatigue (Amfebutamone) C Haematuria Azmacort Hyperglycaemia (Triamcinolone) C Hypokalaemia Albuterol Palpitations (Salbutamol) C Proteinuria Peridex Renal Disorder (Chlorhexidine) C Sinus Arrhythmia Zestril (Lisinopril) C Sinus Bradycardia Vitamins, Unspec (Vitamins, Unspec) C Date:10/19/98ISR Number: 3143643-8Report Type:Expedited (15-DaCompany Report #JAKYO-40808 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Foreign Risperidone PS Janssen ORAL 3 MG DAILY Initial or Prolonged Blood Creatine Health ORAL Phosphokinase Increased Professional Nifedipine C Difficulty In Walking Myalgia Myoglobinuria Oliguria Rhabdomyolysis Date:10/19/98ISR Number: 3143644-XReport Type:Expedited (15-DaCompany Report #JAKYO-40629 Age:29 YR Gender:Male I/FU:F Outcome PT Death Body Temperature Decreased Cardio-Respiratory Arrest Cyanosis Depressed Level Of Consciousness Heart Rate Increased Mydriasis Pulse Pressure Decreased 22-Feb-2006 08:20 AM Page: 322 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Restlessness Thirst Water Intoxication Report Source Product Role Manufacturer Route Dose Duration Foreign Risperidone PS Janssen ORAL 3 MG DAILY Health ORAL; 4 MG Professional DAILY ORAL; 1 MG DAILY ORAL 7 MON Carpipramine (Carpipramine) C Vegetamin B(R) (Vegetamin B(R) ) C Trihexyphenidyl (Trihexyphenidyl) C Triazolam (Triazolam) C Date:10/19/98ISR Number: 3143785-7Report Type:Expedited (15-DaCompany Report #JAFRA-40953 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypotension Foreign Risperdal PS Janssen ORAL ORAL Hospitalization - Health Initial or Prolonged Professional Date:10/19/98ISR Number: 3143787-0Report Type:Expedited (15-DaCompany Report #JAKYO-40829 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Risperidone PS Janssen ORAL 3 MG DAILY Initial or Prolonged Blood Creatine Health ORAL Phosphokinase Increased Professional Pipamperone C Chromaturia Chlorpromazine C Convulsion Promethazine C Electrocardiogram Qt Prolonged Pericarditis Pyrexia Ventricular Fibrillation Date:10/19/98ISR Number: 3143788-2Report Type:Expedited (15-DaCompany Report #JACAN-16889 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Foreign Risperidone PS Janssen ORAL 3 MG 2 DAILY Hospitalization - Perforation Health ORAL Initial or Prolonged Hyperthermia Malignant Professional Anaestetics, General Neuroleptic Malignant Unspecified Syndrome (Unspecified) Ampoule SS INTRAVENOUS INTRAVENOUS Procyclidine C Date:10/19/98ISR Number: 3144492-7Report Type:Expedited (15-DaCompany Report #JAUSA-34068 Age:28 YR Gender:Female I/FU:F Outcome PT Hospitalization - Dyspnoea Initial or Prolonged Neoplasm 22-Feb-2006 08:20 AM Page: 323 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pericardial Disease Pleural Effusion Report Source Product Role Manufacturer Route Dose Duration Health Risperdal Professional (Risperidone) PS ORAL ORAL 3 YR Thiazide (Thiazid-Comp(R) C Zoloft (Sertraline) C Date:10/19/98ISR Number: 3144493-9Report Type:Expedited (15-DaCompany Report #JAUSA-33496 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Health Risperdal Initial or Prolonged Body Temperature Professional (Risperidone) PS ORAL ORAL Increased Coma Laceration Leukocytosis Skin Injury Date:10/22/98ISR Number: 3145405-4Report Type:Expedited (15-DaCompany Report #LIT/98/00270/LEX Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Choreoathetosis Literature Leponex / Clozaril Initial or Prolonged Dyskinesia Health (Clozapine) PS ORAL 400 MG ORAL Required Dystonia Professional Risperidone Intervention to Nausea (Risperidone) SS 5 MG Prevent Permanent Opisthotonus Perphenazine Impairment/Damage Retching (Perphenazine) C Date:10/23/98ISR Number: 3146664-4Report Type:Direct Company Report # Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Propulsid PS Jassen ORAL 10MG ACHS Required Prolonged PO/1MG GHS MD Intervention to Ventricular Tachycardia Respiradol SS Janssen ORAL 1MG Q12H PRN Prevent Permanent PO Impairment/Damage Paxil C Zantac C Reabilan C Lorazepam C Ssi-Reunar C Vancomycin C Date:10/26/98ISR Number: 3147066-7Report Type:Expedited (15-DaCompany Report #JAKYO-40671 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Risperidone PS ORAL 2 MG DAILY Initial or Prolonged Abdominal Pain Lower Health ORAL Constipation Professional Levomepromazine Ileus Paralytic (Levomepromazine) C Promethazine (Promethazine) C 22-Feb-2006 08:20 AM Page: 324 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rilmazafone (Filmazafone) C Date:10/26/98ISR Number: 3147068-0Report Type:Expedited (15-DaCompany Report #JAKYO-40808 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Foreign Risperidone PS Janssen ORAL 3 MG DAILY Initial or Prolonged Blood Creatine Health ORAL Phosphokinase Increased Professional Nifedipine C Difficulty In Walking Gait Disturbance Myalgia Myoglobinuria Oliguria Pain In Extremity Pyrexia Rhabdomyolysis Date:10/26/98ISR Number: 3147215-0Report Type:Expedited (15-DaCompany Report #US 981011475 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Study Olanzapine PS Initial or Prolonged Delusion Other Risperidone SS Psychotic Disorder Date:10/26/98ISR Number: 3147439-2Report Type:Expedited (15-DaCompany Report #LIT/98/00270/LEX Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Leponex PS ORAL 400MG ORAL Initial or Prolonged Choreoathetosis Health Risperidone SS ORAL 5MG ORAL Required Drug Withdrawal Syndrome Professional Perphenazine C Intervention to Dyskinesia Prevent Permanent Dystonia Impairment/Damage Movement Disorder Nausea Retching Date:10/26/98ISR Number: 3147468-9Report Type:Expedited (15-DaCompany Report #JAKYO-40473 Age: Gender:Male I/FU:F Outcome PT Hospitalization - Benign Congenital Initial or Prolonged Hypotonia Blood Creatine Phosphokinase Increased Clonic Convulsion Complications Of Maternal Exposure To Therapeutic Drugs Cyanosis Neonatal Drug Withdrawal Syndrome Neonatal Foetal Distress Syndrome Hyperreflexia 22-Feb-2006 08:20 AM Page: 325 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Irritability Liver Function Test Abnormal Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Foreign Risperidone PS Janssen ORAL 1 MG DAILY Nystagmus Health ORAL Pco2 Increased Professional Flunitrazepam SS ORAL 2 MG DAILY Transient Tachypnoea Of ORAL The Newborn Tremor Date:10/27/98ISR Number: 3148860-9Report Type:Expedited (15-DaCompany Report #JAUSA-34505 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Health Risperdal PS Janssen ORAL 4 MG 1 DAILY Coronary Artery Disease Professional ORAL Drug Toxicity Depakote C Pulmonary Congestion Pulmonary Oedema Date:10/28/98ISR Number: 3148857-9Report Type:Expedited (15-DaCompany Report #HOAFF-41072 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperidone PS Janssen Literature Antidepress. Health Tricyclic Professional (Antidepress. Tricyclic) SS ORAL Valproic Acid (Valproic Acid) SS Date:10/28/98ISR Number: 3148862-2Report Type:Expedited (15-DaCompany Report #HOAFF-41061 Age:58 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperidone PS Janssen ORAL ORAL Literature Health Professional Date:10/28/98ISR Number: 3148865-8Report Type:Expedited (15-DaCompany Report #HOAFF-41072 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperidone PS Janssen VAGINAL Literature Antidepress. Health Tricyclic Professional (Antidepress. Ticyclic) SS ORAL ORAL Valproic Acid SS 22-Feb-2006 08:20 AM Page: 326 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/98ISR Number: 3150109-8Report Type:Expedited (15-DaCompany Report #JAKYO-41126 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myeloid Leukaemia Foreign Risperidone PS Janssen ORAL 2 MG DAILY Initial or Prolonged Health ORAL Professional Haloperidol C Pipamperone Dihydrochloride C Biperiden Hydrochloride C Date:10/30/98ISR Number: 3150110-4Report Type:Expedited (15-DaCompany Report #JAKYO-40829 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Risperidone PS Janssen ORAL 1 MG DAILY Initial or Prolonged Arrhythmia Health ORAL Asthenia Professional Risperidone SS Janssen ORAL 3 MG DAILY Blood Creatine ORAL Phosphokinase Increased Pipamperone SS Janssen ORAL 150 MG DAILY Blood Magnesium Decreased ORAL Cardiac Arrest Chlorpromazine SS ORAL 300 MG DAILY Chills ORAL 9 WK Chromaturia Promethazine C Circulatory Collapse Levomepromazine Convulsion Maleate C Dehydration Nitrazepam C Dyspnoea Pravastatin Sodium C Electrocardiogram Qt Camostat C Prolonged Hyperpyrexia Pericarditis Respiratory Arrest Urinary Tract Disorder Ventricular Fibrillation Ventricular Tachycardia Date:10/30/98ISR Number: 3150120-7Report Type:Expedited (15-DaCompany Report #HOAFF-41072 Age:32 YR Gender:Not SpecifiI/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperidone PS Janssen Literature Antidepress.Tricycli Health c SS ORAL ORAL Professional Valproic Acid SS Date:11/02/98ISR Number: 3150648-XReport Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperidone PS ORAL 2MG BID PO Professional 22-Feb-2006 08:20 AM Page: 327 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/98ISR Number: 3150672-7Report Type:Direct Company Report # Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Penile Pain Health Risperidone PS Janssen 6 MG DAILY 8 WK Priapism Professional Lithium C Depakene C Date:11/02/98ISR Number: 3151635-8Report Type:Expedited (15-DaCompany Report #981005-008013816 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Haloperidol PS ORAL 1 MG, BID, Initial or Prolonged Increased Professional ORAL Haematuria Risperidone SS ORAL .5 MG, BID Kidney Infection ORAL Urinary Retention Risperidone SS ORAL .5 MG, BID, Vesicoureteric Reflux ORAL Sertraline SS ORAL 25 MG, QD, ORAL Valproate Sodium C Olanzapine C Benzatropine Mesilate C Date:11/02/98ISR Number: 3152030-8Report Type:Expedited (15-DaCompany Report #JAKYO-41140 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Foreign Risperidone PS Janssen ORAL 3 MG DAILY Initial or Prolonged Decreased Health ORAL, 2 MG Blood Urea Decreased Professional DAILY 16 DAY Electrolyte Imbalance Haloperidol C Face Oedema Sulpiride C Hepatic Function Abnormal Amitriptyline Oedema Peripheral Hydochloride C Tiaride Hydrochloride C Levomepromazine Maleate C Promethazine Hydrochloride C Biperiden Hydrochlorde C Lithium Carbonate C Spironolactone C Vegetamin B C Date:11/02/98ISR Number: 3152035-7Report Type:Expedited (15-DaCompany Report #JAUSA-33982 Age:92 YR Gender:Male I/FU:F Outcome PT Death Agitation Hospitalization - Aneurysm Initial or Prolonged Atherosclerosis Atrial Fibrillation Cardiomegaly Colour Blindness Confusional State 22-Feb-2006 08:20 AM Page: 328 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Conjunctivitis Convulsion Coronary Artery Disease Report Source Product Role Manufacturer Route Dose Duration Dementia Alzheimer'S Type Consumer Risperdal PS Janssen ORAL 1 MG 2 DAILY Difficulty In Walking ORAL Dysarthria Navane C Ecchymosis Amanadine C Haemorrhagic Stroke Hypertension Lacrimation Increased Lethargy Memory Impairment Muscle Rigidity Nasal Congestion Ocular Hyperaemia Parkinson'S Disease Pneumonia Purpura Subdural Haematoma Urinary Retention Urinary Tract Infection Date:11/03/98ISR Number: 3151493-1Report Type:Expedited (15-DaCompany Report #981005-008013817 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Angioneurotic Oedema Health Haloperidol PS INTRAMUSCULAR UNKNOWN, TIW, Mental Disorder Professional IM Oedema Peripheral (INTRAMUSCULA R) Risperidone SS ORAL 1 TAB, QD, ORAL Inovane SS ORAL 3.75 MG, BID, ORAL Artane SS ORAL 10 MG, QD, ORAL Lysanxia SS ORAL 40 MG, QD, ORAL Date:11/04/98ISR Number: 3151829-1Report Type:Direct Company Report # Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Risperdal PS ORAL 1 MG PO Q4HR 3 DAY Consciousness Feosol C 300 MG BID Lethargy Zoloft C 100 MG BID Ditropan C 5 MG TID Sinemet 50-200 C ORAL 1 TABLET TID Sinemet 25 - 100 C 1 TABLET QD Imdur C 60 MG QD Pepcid C 40 MG QD Mirapex 0.25 Mg C 1 1/2 TID Butizol 30 Mg C 30 MG TID Synthroid 0.1 Mg C 0.1MG QD 22-Feb-2006 08:20 AM Page: 329 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/98ISR Number: 3152466-5Report Type:Expedited (15-DaCompany Report #JAKYO-40522 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Risperidone PS Janssen ORAL SEE IMAGE / Body Temperature Health ORAL; Increased Professional GRANULES 20 DAY Electrocardiogram Clocapramine SS ORAL SEE IMAGE / Abnormal ORAL 9 DAY Neuroleptic Malignant Brotizolam C Syndrome Biperiden Sinus Arrhythmia Hydrochloride C Sinus Bradycardia Etizolam C Date:11/09/98ISR Number: 3153538-1Report Type:Expedited (15-DaCompany Report #JAUSA-33815 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amyotrophic Lateral Health Risperdal PS Jansen ORAL 2 MG 1 DAILY Sclerosis Professional ORAL Condition Aggravated Sedation Speech Disorder Tremor Date:11/10/98ISR Number: 3154448-6Report Type:Expedited (15-DaCompany Report #JANZL-41339 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Qt Foreign Risperdal PS Janssen ORAL ORAL Prolonged Health Benztropine Hepatic Steatosis Professional (Benztropine) SS Temazepam (Temazepam) SS Date:11/10/98ISR Number: 3154450-4Report Type:Expedited (15-DaCompany Report #JAUK-41084 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Foreign Risperdal PS Janssen ORAL 4 MG 2 DAILY Interstitial Lung Disease Health ORAL Professional Gliclazide (Gliclazide) C Amoxycillin (Amoxicillin) C Ciprofloxazin (Ciprofloxacin) C Date:11/10/98ISR Number: 3154452-8Report Type:Expedited (15-DaCompany Report #JAKYO-40671 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Risperidone PS Janssen ORAL 2 MG DAILY Initial or Prolonged Constipation Health ORAL Gastric Cancer Professional Levomepromazine SS ORAL 100 MG DAILY Ileus Paralytic ORAL Promethazine (Promethazine) C 22-Feb-2006 08:20 AM Page: 330 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rilmazafone (Rilmazafone) C Thioridazine Hydrochloride (Thioridazine) C Date:11/10/98ISR Number: 3154453-XReport Type:Expedited (15-DaCompany Report #JAKYO-40829 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Risperidone PS Janssen ORAL 1 MG DAILY Initial or Prolonged Arrhythmia Health ORAL Asthenia Professional Pipamperone Blood Creatine (Pipamperone), Phosphokinase Increased Janssen, Tablet SS Janssen ORAL 150 MG DAILY Blood Magnesium Decreased ORAL Cardio-Respiratory Arrest Chlorpromazine Chromaturia (Chlorpromazine) SS ORAL 300 MG DAILY 9 WK Circulatory Collapse Promethazine Convulsion (Promethazine) C Dehydration Levomepromazine Dyspnoea Maleate Electrocardiogram Qt (Levomepromazine) C Prolonged Nitrazepam Heart Rate Irregular (Nitrazepam) C Infection Pravastatin Sodium Pericarditis (Pravastatin) C Pyrexia Camostat (Camostat) C Torsade De Pointes Ventricular Fibrillation Ventricular Tachycardia Date:11/11/98ISR Number: 3155019-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apnoea Risperidone PS 3 MG BID Drug Effect Decreased Oxazepam C Dyspnoea Trazodone C Sertraline C Date:11/12/98ISR Number: 3156429-5Report Type:Direct Company Report # Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Serzone PS 250MG BID Coma Risperdal SS 1.0 MG Q PM Hypotension Date:11/12/98ISR Number: 3156522-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyskinesia Risperdal PS ORAL 4MG DAILY PO Intervention to Extrapyramidal Disorder Prevent Permanent Speech Disorder Impairment/Damage 22-Feb-2006 08:20 AM Page: 331 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/98ISR Number: 3156643-9Report Type:Expedited (15-DaCompany Report #USA/98/02630/REST Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Restoril PS ORAL 30 MG ORAL Initial or Prolonged Consciousness Risperdal SS ORAL 2 MG ORAL Pupillary Reflex Impaired Paxil SS ORAL 20 MG ORAL Pupils Unequal Antibiotics C Stupor Date:11/16/98ISR Number: 3158310-4Report Type:Expedited (15-DaCompany Report #JAFRA-40475 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Foreign Risperdal Hospitalization - Completed Suicide Health (Risperidone) PS Janssen ORAL ORAL Initial or Prolonged Electrocardiogram Qrs Professional Prothiaden Complex Prolonged (Dosulepine) SS Fall Malaise Mydriasis Sinus Bradycardia Date:11/16/98ISR Number: 3158313-XReport Type:Expedited (15-DaCompany Report #JAUK-40753 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Thyroid Stimulating Foreign Risperdal Initial or Prolonged Hormone Decreased Health (Risperidone) PS Janssen ORAL .5 MG 2 DAILY Circulatory Collapse Professional ORAL Hyperthyroidism Digoxin C Tri-Iodothyronine Aspirin C Increased Date:11/16/98ISR Number: 3158316-5Report Type:Expedited (15-DaCompany Report #JAUK-41476 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Foreign Risperdal Femur Fracture Health (Risperidone) PS Janssen ORAL .5 MG DAILY Pneumonia Professional ORAL 4 DAY Pyelonephritis Date:11/17/98ISR Number: 3158577-2Report Type:Expedited (15-DaCompany Report #JAKYO-40473 Age: Gender:Male I/FU:F Outcome PT Hospitalization - Benign Congenital Initial or Prolonged Hypotonia Bradycardia Foetal Complications Of Maternal Exposure To Therapeutic Drugs Congenital Anomaly Convulsion Neonatal Cyanosis Neonatal Eye Movement Disorder Hyperreflexia 22-Feb-2006 08:20 AM Page: 332 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Irritability Liver Function Test Abnormal Report Source Product Role Manufacturer Route Dose Duration Muscle Twitching Foreign Risperidone PS Janssen ORAL 1MG DAILY Nystagmus Health ORAL Prolonged Labour Professional Flunitrazepam Transient Tachypnoea Of (Flunitrazepam) The Newborn Tablet SS ORAL 2MG DAILY Tremor Neonatal ORAL Date:11/18/98ISR Number: 3159468-3Report Type:Expedited (15-DaCompany Report #JAKYO-41126 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Genital Ulceration Foreign Risperidone Initial or Prolonged Haemoglobin Decreased Health (Risperidone) PS Janssen ORAL 1 MG DAILY Hepatocellular Damage Professional ORAL AND 2 MG Liver Function Test DAILY Abnormal Haloperidol Myeloid Leukaemia (Haloperidol) C Pancytopenia Pipamperone Platelet Count Decreased Dihydrochloride White Blood Cell Count (Pipamperone) C Increased Date:11/18/98ISR Number: 3159469-5Report Type:Expedited (15-DaCompany Report #JAUK-41539 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aplastic Anaemia Foreign Risperidone Pancytopenia (Risperidone) PS Janssen ORAL ORAL Thrombocytopenia Date:11/18/98ISR Number: 3163714-XReport Type:Expedited (15-DaCompany Report #JANZL-41339 Age:22 YR Gender:Male I/FU:F Outcome PT Death Adrenal Disorder Atelectasis Atherosclerosis Cardiac Disorder Drug Interaction Electrocardiogram Qt Prolonged Electrolyte Imbalance Hepatic Function Abnormal Hepatic Necrosis Hepatic Steatosis Hepatotoxicity Lipid Metabolism Disorder Lung Disorder Overdose Pancreatic Disorder Pleural Effusion Pulmonary Congestion Pulmonary Oedema Pulmonary Vascular Disorder 22-Feb-2006 08:20 AM Page: 333 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Tubular Necrosis Renal Vessel Disorder Spleen Disorder Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal PS ORAL ORAL Health Benztropine SS ORAL ORAL Professional Temazepam SS ORAL ORAL Date:11/19/98ISR Number: 3160962-XReport Type:Direct Company Report # Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Risperidone PS QD Initial or Prolonged Coma Paxil SS QD Headache Intentional Overdose Orthostatic Hypotension Sedation Speech Disorder Vomiting Date:11/20/98ISR Number: 3160796-6Report Type:Expedited (15-DaCompany Report #JABEL-41591 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Foreign Risperdal PS ORAL 7 MG 1 DAILY Initial or Prolonged Fluctuation Study ORAL Cardiac Disorder Health Supradyn C Heart Rate Irregular Professional Hydergine C Stilnoct C Date:11/20/98ISR Number: 3160924-2Report Type:Expedited (15-DaCompany Report #B042479 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Dutonin PS ORAL ORAL Initial or Prolonged Drug Interaction Health Risperidone SS ORAL ORAL Professional Date:11/24/98ISR Number: 3162347-9Report Type:Expedited (15-DaCompany Report #JAUK-41610 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Foreign Risperidone Initial or Prolonged Study (Risperidone) PS ORAL 6 MG DAILY Health ORAL; 4 MG Professional DAILY Date:11/25/98ISR Number: 3164052-1Report Type:Direct Company Report # Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperidone PS Phosphokinase Increased Body Temperature Increased Hypertension 22-Feb-2006 08:20 AM Page: 334 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/98ISR Number: 3164124-1Report Type:Direct Company Report # Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lactation Disorder Risperdal PS 2 MG Q HS Menstruation Irregular Serzone C Date:11/27/98ISR Number: 3163634-0Report Type:Expedited (15-DaCompany Report #JAKYO-40829 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Risperidone PS Janssen ORAL 3 MG DAILY Initial or Prolonged Asthenia Health ORAL (SEE Blood Creatine Professional IMAGE) Phosphokinase Increased Pipamperone SS Janssen ORAL 150 MG DAILY Blood Magnesium Decreased ORAL (SEE Cardio-Respiratory Arrest IMAGE) Chills Chlorpromazine SS ORAL 300 MG DAILY Chromaturia ORAL 26 MON Circulatory Collapse Levomepromazine Coma Maleae Convulsion (Levomepromazine) SS ORAL 25 MG DAILY Dyspnoea ORAL 26 MON Electrocardiogram Qt Promethazine C Prolonged Nitrazepam C Heart Rate Irregular Pravastatin Sodium C Myopericarditis Camostat C Pyrexia Vegetamin A C Urinary Tract Infection Ventricular Fibrillation Date:11/27/98ISR Number: 3163636-4Report Type:Expedited (15-DaCompany Report #JAKYO-41126 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myeloid Leukaemia Foreign Risperidone PS Janssen ORAL 1 MG DAILY Initial or Prolonged Dermatitis Health ORAL-2 MG Genital Ulceration Professional DAILY ORAL Hepatocellular Damage Haloperidol C Liver Function Test Pipamperone Abnormal Dihydrochloride C Pancytopenia Biperiden White Blood Cell Count Hydrochloride C Decreased Date:11/27/98ISR Number: 3163638-8Report Type:Expedited (15-DaCompany Report #JAKYO-41608 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Risperidone PS Janssen ORAL 2 MG DAILY Blood Urea Decreased Health ORAL Depressed Level Of Professional Haloperidol C Consciousness Brotizolam C Immune System Disorder Sodium Valproate C Pneumonia Subarachnoid Haemorrhage White Blood Cell Count Increased 22-Feb-2006 08:20 AM Page: 335 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/98ISR Number: 3163872-7Report Type:Expedited (15-DaCompany Report #JAKYO-41140 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Decreased Foreign Risperidone PS Janssen ORAL 3 MG DAILY Initial or Prolonged Blood Urea Decreased Health ORAL Dizziness Professional Lithium Carbonate SS ORAL 300 MG DAILY Drug Ineffective ORAL Electrolyte Imbalance Haloperidol C Face Oedema Sulpiride C Ileus Paralytic Amitriptyline Liver Disorder Hydrochloride C Oedema Peripheral Tiapride Hydrochloride C Promethazine Hydrochloride C Biperiden Hydrochloride C Flunitrazepam C Spironolactone C Vegetamin B C Levomepromzine Maleate C Alosenn C Sennoside C Sodium Picosulfate C Date:11/30/98ISR Number: 3163915-0Report Type:Expedited (15-DaCompany Report #9907779 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Depakene PS ORAL PO Initial or Prolonged Hyponatraemia Health Risperidone SS ORAL PO Other Pneumonia Aspiration Professional Risperidone C Polydipsia Other Levomepromazine C Date:11/30/98ISR Number: 3164060-0Report Type:Expedited (15-DaCompany Report #9277/18276 Age:57 YR Gender:Female I/FU:I Outcome PT Death Acute Respiratory Hospitalization - Distress Syndrome Initial or Prolonged Binocular Eye Movement Disorder Blood Pressure Decreased Bowel Sounds Abnormal Breath Sounds Abnormal Cardio-Respiratory Arrest Cold Sweat Coma Completed Suicide Condition Aggravated Corneal Reflex Decreased Crepitations Drug Level Above Therapeutic Hyporeflexia Hypotension Hypothermia Hypoventilation 22-Feb-2006 08:20 AM Page: 336 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intentional Overdose Malaise Nausea Report Source Product Role Manufacturer Route Dose Duration Pallor Health Xanax PS ORAL OD-MG-1 Paranoia Professional DOSE;ORAL Pneumonia Aspiration Xanax SS ORAL TABLETS/.25 Pneumothorax Traumatic MG/DAY Pupillary Reflex Impaired PRN;ORAL;01 Respiratory Depression DO Vein Disorder Ibuprofen SS ORAL ORAL Vomiting Risperdal SS ORAL OD - 15-1DOSE (A);ORAL Anafranil C Paxil C Tranxene C Medroxyprogesterone Acetate C Dicyclomine C Propulsid C Ibuprofen C Midrin C Premarin C Poly-Histine-D C Norvasc C Prilosec C Restoril C Prempro C Date:12/01/98ISR Number: 3164972-8Report Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Risperdal PS ORAL 1 MG PO BID Illusion Benadryl SS ORAL 25 MG PO BID Date:12/01/98ISR Number: 3165171-6Report Type:Expedited (15-DaCompany Report #981124-008014689 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Consumer Haldol PS ORAL ORAL Hospitalization - Fracture Risperidone SS ORAL 10 MG, QD, Initial or Prolonged Miosis ORAL Myocardial Infarction Tamoxifen C Schizophrenia Levothyroxine C Alcohol C Date:12/02/98ISR Number: 3165575-1Report Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Risperdal PS ORAL 1 MG PO BID Illusion Benadryl SS ORAL 25MG PO BID 22-Feb-2006 08:20 AM Page: 337 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/98ISR Number: 3166582-5Report Type:Expedited (15-DaCompany Report #981124-008014689 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Consumer Haldol PS ORAL ORAL Hospitalization - Hip Fracture Risperidone SS ORAL 10 MG, QD, Initial or Prolonged Miosis ORAL Myocardial Infarction Tamoxifen C Schizophrenia Levothyroxine C Alcohol C Date:12/04/98ISR Number: 3167234-8Report Type:Expedited (15-DaCompany Report #M090167 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Mitral Valve Prolapse Health Trazodone PS ORAL 150 MG QD Hospitalization - Professional ORAL 1 MON Initial or Prolonged Serzone SS ORAL 300 MG QD ORAL Risperdal SS 3 MG Xanax SS 2.5 MG QD Klonopin SS 1 MG QID Date:12/04/98ISR Number: 3167554-7Report Type:Expedited (15-DaCompany Report #JACAN -16889 Age:24 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diverticular Perforation Foreign Risperidone PS Janssen ORAL 3 MG 2 DAILY Hospitalization - Hyperthermia Malignant Health ORAL Initial or Prolonged Lung Disorder Professional Anaestetics, General Neuroleptic Malignant Unspecified Ampoule SS INTRAVENOUS INTRAVENOUS Syndrome Procyclydine C Pulmonary Oedema Renal Tubular Necrosis Steatorrhoea Date:12/04/98ISR Number: 3167556-0Report Type:Expedited (15-DaCompany Report #JAUK-41539 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aplastic Anaemia Foreign Risperidone PS Janssen ORAL ORAL Pancytopenia Carbamazepine SS ORAL ORAL Thrombocytopenia Phenytoin SS Date:12/04/98ISR Number: 3167559-6Report Type:Expedited (15-DaCompany Report #JAKYO-40522 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Risperidone PS Janssen ORAL 6 MG DAILY Neuroleptic Malignant Health ORAL Syndrome Professional Biperiden Sinus Arrhythmia Hydrochloride SS ORAL 3 MG DAILY Sinus Bradycardia ORAL Brotizolam SS Etizolam SS ORAL 3 MG DAILY 3 DAY Clocapramine SS ORAL 50 MG DAILY ORAL 98 DAY 22-Feb-2006 08:20 AM Page: 338 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/98ISR Number: 3167562-6Report Type:Expedited (15-DaCompany Report #JAKYO-40829 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Risperidone PS Janssen ORAL 3 MG DAILY Initial or Prolonged Arrhythmia Health ORAL Blood Creatine Professional Pipamperone SS Janssen ORAL 150 MG DAILY Phosphokinase Increased ORAL Blood Magnesium Decreased Chlorpromazine SS ORAL 300 MG DAILY Chills ORAL 26 MON Chromaturia Levomepromazine Convulsion Maleate SS ORAL 25 MG DAILY Dehydration Camostat C Dyspnoea Vegetamin A C Electrocardiogram Promethazine C Abnormal Nitrazepam C Electrocardiogram Qt Pravastatin Sodium C Prolonged Myocardial Ischaemia Myopericarditis Pyrexia Shock Torsade De Pointes Urinary Tract Infection Ventricular Fibrillation Ventricular Tachycardia Date:12/04/98ISR Number: 3167564-XReport Type:Expedited (15-DaCompany Report #JAUK-41713 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Foreign Risperidone PS Janssen ORAL 2 MG DAILY Hospitalization - Malnutrition ORAL Initial or Prolonged Pancytopenia Fluoxetine C Protein Total Decreased Iv Fluids C Pulmonary Oedema Starvation Date:12/04/98ISR Number: 3167566-3Report Type:Expedited (15-DaCompany Report #JAESP-41736 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eosinophilia Foreign Risperdal PS Janssen ORAL 5 MG DAILY Initial or Prolonged Rash Maculo-Papular Health ORAL Professional Tegretol SS ORAL 1.2 G DAILY ORAL Akineton SS ORAL DAILY 23 DAY Noctamid C Emportal C Seroxat C Date:12/04/98ISR Number: 3167568-7Report Type:Expedited (15-DaCompany Report #JAKYO-41660 Age:66 YR Gender:Female I/FU:I Outcome PT Other Abdominal Distension Abdominal Pain Constipation Ileus Paralytic 22-Feb-2006 08:20 AM Page: 339 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Risperidone PS Janssen ORAL 2 MG DAILY Health ORAL Professional Flunitrazepam C Biperiden Hydrochloride C Alosenn C Famotidine C Teprenone C Emedastine Difunarate C Zopliclone C Tiapride Hydrochloride C Date:12/04/98ISR Number: 3167570-5Report Type:Expedited (15-DaCompany Report #JAUSA-35231 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Consumer Risperdal PS Janssen ORAL 10 MG DAILY Miosis ORAL Myocardial Infarction Haldol (Haloperidol) SS Janssen ORAL ORAL Tamoxifen C Synthroid C Alcohol C Date:12/04/98ISR Number: 3167572-9Report Type:Expedited (15-DaCompany Report #JAUSA-35258 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Risperdal PS Janssen ORAL ORAL Initial or Prolonged Prolonged Professional Date:12/07/98ISR Number: 3167804-7Report Type:Expedited (15-DaCompany Report #JAUK-41539 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aplastic Anaemia Foreign Risperidone PS Janssen ORAL Pancytopenia Carbamazepine SS ORAL Sepsis Phenytoin SS 6 MON Thrombocytopenia Date:12/07/98ISR Number: 3167902-8Report Type:Expedited (15-DaCompany Report #981202-008014808 Age:49 YR Gender:Male I/FU:I Outcome PT Death Alanine Aminotransferase Hospitalization - Increased Initial or Prolonged Blood Creatine Phosphokinase Increased Cachexia Cerebellar Syndrome Communication Disorder Depressed Level Of Consciousness 22-Feb-2006 08:20 AM Page: 340 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Malaise Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Pyrexia Foreign Haloperidol PS ORAL 12 MG, QD, Thrombocytopenia Health ORAL Professional Risperidone SS ORAL 2 MG, QD, ORAL Perciazine SS ORAL 90 DROP, QD, ORAL Levomepromazine SS INTRAMUSCULAR 75 MG, QD, IM Loxapac SS INTRAMUSCULAR 200 MG, QD, IM Largactil SS ORAL ORAL Laxpine C Chlorpromazine C Date:12/07/98ISR Number: 3167938-7Report Type:Expedited (15-DaCompany Report #JAAUS-41725 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperidone PS Janssen ORAL 1 MG DAILY Health Lithium Carbonate Professional (Litium Carbonate) C Lithium Carbonate (Lithium Carbonate) C Venlafaxine (Venlafaxine) C Iron (Iron) C Coloxyl With Senna C Lactulose C Date:12/07/98ISR Number: 3167950-8Report Type:Expedited (15-DaCompany Report #JAUSA-35300 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Health Risperdal PS Janssen ORAL 1 MG 1 DAILY Hospitalization - Phosphokinase Increased Professional Initial or Prolonged Confusional State Muscle Rigidity Neuroleptic Malignant Syndrome Pneumonia Pyrexia Date:12/07/98ISR Number: 3167952-1Report Type:Expedited (15-DaCompany Report #JAUSA-35231 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Consumer Risperdal PS Janssen ORAL 10 MG DAILY Coronary Artery Haldol SS Janssen ORAL Atherosclerosis Tamoxifen Hip Fracture (Tamoxifen) C Mental Disorder Synthroid Miosis (Levothyroxine) C Myocardial Infarction Alcohol (Alcohol) C 22-Feb-2006 08:20 AM Page: 341 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/98ISR Number: 3168249-6Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Risperidone PS ORAL 8MG / HS / PO Phosphokinase Increased Benztropine Mesylate C Depressed Level Of Buspirone Hcl C Consciousness Bisacodyl C Pyrexia Lactulose C Restless Legs Syndrome Trazodone C Multi-Vitamin C Paroxetine C Date:12/08/98ISR Number: 3167930-2Report Type:Expedited (15-DaCompany Report #9839924 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Consumer Navane PS ORAL ORAL Initial or Prolonged Drug Ineffective Olanzapine SS ORAL ORAL Required Hallucination Risperidone SS ORAL ORAL Intervention to Sedation Prozac SS ORAL ORAL Prevent Permanent Social Avoidant Behaviour Cogentin C Impairment/Damage Suicide Attempt Thinking Abnormal Date:12/08/98ISR Number: 3167959-4Report Type:Expedited (15-DaCompany Report #1078035A Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Health Ibuprofen PS ORAL PO Hospitalization - Distress Syndrome Professional Risperdal SS ORAL APPROX 15 MG, Initial or Prolonged Cardio-Respiratory Arrest Other ONCE, PO Coma Xanax SS ORAL 15MG, ONCE, Completed Suicide PO Hypotension Tranxene SS Hypothermia Midrin SS Intentional Overdose Medroxyprogesterone SS Pneumonia Aspiration Premarin SS Pneumothorax Histine SS Respiratory Distress Dicyclomine SS Propulsid C Anafranil C Paxil C Norvasc C Prilosec C Restoril C Prempro C Date:12/09/98ISR Number: 3168762-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Risperidal PS ORAL 2 MG PO QHS Initial or Prolonged Neuroleptic Malignant Tegretol SS ORAL 200 MG PO TID Other Syndrome 22-Feb-2006 08:20 AM Page: 342 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/98ISR Number: 3169495-8Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diplopia Plaquenil PS ORAL 200MG PO QHS Initial or Prolonged Heat Stroke Risperdol SS ORAL 3.5MG PO BID Other Hyperventilation Loss Of Consciousness Date:12/09/98ISR Number: 3169515-0Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperidal PS ORAL 4 MG PO BID Initial or Prolonged Dehydration Other Ventricular Tachycardia Date:12/09/98ISR Number: 3169551-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Risperidone PS ORAL 1MG PO Q HS Initial or Prolonged Agitation Other Difficulty In Walking Hallucination Muscle Rigidity Date:12/09/98ISR Number: 3170427-7Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradykinesia Risperidone PS ORAL 2MG PO QID Initial or Prolonged Dysphagia Other Muscle Rigidity Parkinsonism Date:12/10/98ISR Number: 3169930-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Galactorrhoea Health Risperidone PS ORAL ORAL Intervention to Professional Prevent Permanent Impairment/Damage Date:12/11/98ISR Number: 3169717-3Report Type:Expedited (15-DaCompany Report #AUS/98/00160/LEX Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Study Clozaril (Clozapine) PS ORAL 700 MG ORAL Hospitalization - Bone Marrow Depression Health Risperidone Initial or Prolonged Dementia Professional (Risperidone) SS ORAL 4 MG ORAL Required Leukopenia Lithium (Lithium) C Intervention to Mental Impairment Fluoxetine Prevent Permanent Sepsis (Fluoxetine) C Impairment/Damage Thrombocytopenia Valproate (Valproate Sodium) C 22-Feb-2006 08:20 AM Page: 343 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/98ISR Number: 3169747-1Report Type:Expedited (15-DaCompany Report #JAUSA-35068 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anticholinergic Syndrome Health Risperdal PS ORAL 3 MG 2 DAILY 3 WK Completed Suicide Professional Artane SS ORAL 5 MG 2 DAILY Cyproheptadine SS Klonopin C Xanax (Alprazolam) C Date:12/11/98ISR Number: 3169800-2Report Type:Expedited (15-DaCompany Report #JAFRA-40953 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradyphrenia Foreign Risperdal PS Janssen ORAL SEE IMAGE Hospitalization - Cardiac Arrest Health Bricanyl C Initial or Prolonged Hypotension Professional Mopral C Levothyrox C Fludrocortisone C Hydrocortisone C Depakine Chrono C Rivotril C Theralene C Date:12/11/98ISR Number: 3170133-9Report Type:Direct Company Report # Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperidone PS 1 MG BID Initial or Prolonged Insomnia Professional Sertraline SS 50 MG QD Irritability Valium C Mood Swings St. Johns Wort C Restlessness Valerian Root C Tremor Date:12/14/98ISR Number: 3170557-XReport Type:Expedited (15-DaCompany Report #9835988 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Foreign Zoloft PS ORAL 50.00 MG Intervention to Depression Health TOTAL : Prevent Permanent Diarrhoea Professional DAILY: ORAL Impairment/Damage Drug Interaction Risperidone SS ORAL 4.00 MG Extrapyramidal Disorder TOTAL: BID: Hyperhidrosis ORAL Salivary Hypersecretion Amisulpride C Sedation Potassium Serotonin Syndrome Chlorazepate C Vomiting Date:12/16/98ISR Number: 3171144-XReport Type:Expedited (15-DaCompany Report #JAUSA-35345 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Risperdal Initial or Prolonged Pulmonary Embolism Professional (Risperidone) PS Janssen ORAL -, ORAL Remeron C 22-Feb-2006 08:20 AM Page: 344 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/98ISR Number: 3171146-3Report Type:Expedited (15-DaCompany Report #JAUSA-35415 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperdal Initial or Prolonged Hallucination Professional (Risperidone) PS Janssen ORAL 6 MG DAILY ORAL; 1 MG DAILY Date:12/16/98ISR Number: 3171147-5Report Type:Expedited (15-DaCompany Report #JAUSA-35300 Age:84 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Risperdal Hospitalization - Blood Creatine Professional (Risperidone) PS Janssen ORAL 1 MG 1 DAILY Initial or Prolonged Phosphokinase Increased ORAL 2 MG 1 Confusional State DAILY 6 MON Dysphagia Muscle Rigidity Myocardial Infarction Neuroleptic Malignant Syndrome Pneumonia Pyrexia Weight Decreased Date:12/16/98ISR Number: 3171149-9Report Type:Expedited (15-DaCompany Report #JAUSA-35331 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Risperdal Cardiac Failure Professional (Risperidone) PS Janssen ORAL 1 MG 1 DAILY Congestive ORAL Date:12/16/98ISR Number: 3171151-7Report Type:Expedited (15-DaCompany Report #JAUSA-35335 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Risperdal Hospitalization - Congestive Professional (Risperidone) PS Janssen ORAL .5 MG 1 DAILY Initial or Prolonged Respiratory Failure ORAL Date:12/16/98ISR Number: 3171154-2Report Type:Expedited (15-DaCompany Report #JAUSA-35390 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Risperdal Initial or Prolonged Hip Fracture Professional (Risperidone) PS Janssen ORAL .5 MG 1 DAILY Muscle Spasms ORAL Respiratory Arrest Demerol (Pethidine) Ampoule SS INTRAVENOUS 50 MG SINGLE INTRAVENOUS Lanoxin C Toprol Xl C Diovan C Nitroglycerin C Procardia C 22-Feb-2006 08:20 AM Page: 345 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/98ISR Number: 3171158-XReport Type:Expedited (15-DaCompany Report #JAKYO-41647 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death C-Reactive Protein Foreign Risperidone PS Janssen ORAL 2 MG DAILY Hospitalization - Increased Health ORAL Initial or Prolonged Decreased Activity Professional Methylphenidate Depressed Level Of Hydrochloride SS ORAL 20 MG DAILY Consciousness ORAL Disseminated Sodium Valproate SS ORAL 600 MG DAILY Intravascular Coagulation ORAL 17 MON Flatulence Pravastatin Sodium SS ORAL 20 MG DAILY Hyperhidrosis ORAL 14 MON Hyperthermia Malignant Cetraxate Hypoxia Hydrochloride SS ORAL 400 MG DAILY Malaise ORAL 5 DAY Multi-Organ Failure Muscle Rigidity Neuroleptic Malignant Syndrome Renal Failure Vomiting Date:12/17/98ISR Number: 3170827-5Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Risperidal PS ORAL 1 ORALLY AT Delusional Disorder, BEDTIME 5 DAY Persecutory Type Zoloft SS Nausea Date:12/18/98ISR Number: 3171656-9Report Type:Expedited (15-DaCompany Report #981001-107013759 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Haldol PS 10 DAY Confusional State Professional Risperidone SS ORAL .5 MG, BID Depressed Level Of ORAL Consciousness Quetiapine Fumarate SS ORAL 12.5 MG, BID Haematuria ORAL Joint Stiffness Neuroleptic Malignant Syndrome Pyrexia Date:12/18/98ISR Number: 3172439-6Report Type:Direct Company Report # Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Withdrawal Syndrome Risperidone PS ORAL 2MG BID PO Intervention to Dyskinesia Multivitamin C Prevent Permanent Tardive Dyskinesia Cozaar C Impairment/Damage Tongue Disorder Isopto Carbachol C Aziphagan C Nortriptylline C Vitamin C Clotrimazole C Klonopin C 22-Feb-2006 08:20 AM Page: 346 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hctz C Atrovent C Vitamin E C Ambien C Date:12/18/98ISR Number: 3172610-3Report Type:Direct Company Report # Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Risperdal PS ORAL 3 MGM BID PO Depakote SS ORAL 500 MGM PO BID Date:12/21/98ISR Number: 3172204-XReport Type:Expedited (15-DaCompany Report #8-98345-069A Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Discomfort Health Effexor PS ORAL ORAL Initial or Prolonged Drooling Professional Risperdal Dystonia (Risperidone) Eye Rolling Tablets SS ORAL 1 MG DAILY Tongue Oedema ORAL Date:12/21/98ISR Number: 3172692-9Report Type:Expedited (15-DaCompany Report #JAKYO-41734 Age:50 YR Gender:Female I/FU:I Outcome PT Death Akathisia Anxiety Binocular Eye Movement Disorder Blister Blood Creatine Phosphokinase Increased Blood Pressure Decreased Body Temperature Decreased Cardiac Disorder Cardiac Fibrillation Coma Corneal Reflex Decreased Cyanosis Delusion Diarrhoea Dyspnoea Electrocardiogram Abnormal Gastric Dilatation Hallucination Hyperhidrosis Hypotension Lacrimation Increased Liver Function Test Abnormal Muscle Rigidity Musculoskeletal Stiffness Myoglobin Blood Increased Negativism 22-Feb-2006 08:20 AM Page: 347 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Pain Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Foreign Risperidone PS ORAL 2 MG DAILY Pupil Fixed Health ORAL Rash Erythematous Professional Levomepromazine Speech Disorder Maleate SS ORAL 160 MG DAILY Stupor ORAL Suicidal Ideation Risperidone (Risperidone) SS Levomepromazine Maleate SS Risperidone SS ORAL 14 MG DAILY ORAL Sulpiride (Sulpiride) SS 800 MG DAILY ORAL Sulpiride (Sulpiride) SS Sodium Valproate C Diazepam (Diazepam) C Flunitrazepam (Flunitrazepam) C Sennoside (Sennosides) C Carbamazepine (Carbamazepine) C Levomepromazine Maleate C Triazolam (Triazolam) C Date:12/21/98ISR Number: 3172693-0Report Type:Expedited (15-DaCompany Report #JADEN-42225 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Function Abnormal Foreign Risperdal PS ORAL 1 MG DAILY ORAL Risperdal (Risperidone) SS Cardil (Diltiazem) C Panodil (Paracetamol) C Date:12/21/98ISR Number: 3172694-2Report Type:Expedited (15-DaCompany Report #JAKYO-41580 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Risperidone PS ORAL 2 MG DAILY Initial or Prolonged Delusion Health ORAL Drug Effect Decreased Professional Pimozide (Pimozide) C Excitability Haloperidol Suicide Attempt (Haloperidol) C Trihexyphenidyl Hydrochloride (Trihexyphenidyl) C Flunitrazepam (Flunitrazepam) C 22-Feb-2006 08:20 AM Page: 348 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/98ISR Number: 3173412-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombotic Risperidol PS ORAL 4 MG PO HS Thrombocytopenic Purpura Date:12/23/98ISR Number: 3173367-2Report Type:Direct Company Report # Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypotension Risperidone PS Jannsen ORAL 0.5 MG BID PO Hospitalization - Hypoventilation Paxil C Initial or Prolonged Loss Of Consciousness Sinemet Cr C Muscle Rigidity Lorazepam C Respiratory Failure Date:12/24/98ISR Number: 3229424-5Report Type:Periodic Company Report #A001-002-002684 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Aricept (Donepezil) PS ORAL 5 MG (1 IN 1 Initial or Prolonged Muscular Weakness Professional D), PER ORAL Risperdal (Risperidone) SS ORAL 1 MG (1 IN 1 D), PER ORAL; .5 MG DAILY, PER ORAL Ativan C Prozac C ..... C Date:12/28/98ISR Number: 3176366-XReport Type:Expedited (15-DaCompany Report #981218-107058966 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Haldol Injection Initial or Prolonged Phosphokinase Increased Professional (Haloperidol) PS INTRAMUSCULAR PRN, IM Catatonia (INTRAMUSCULA Muscle Rigidity R) Neuroleptic Malignant Risperidal Syndrome (Risperidone) SS ORAL 2 MG, BID, Pneumonia ORAL Pupils Unequal Antibiotic, Nos C Pyrexia Rhabdomyolysis Urinary Tract Infection Date:12/29/98ISR Number: 3174132-2Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janessen 0.5MG Q AM 3 DAY Confusional State Professional Monopril C Decreased Appetite Multivitamin C Difficulty In Walking Furosemide C Hallucination K-Dur C Muscular Weakness Temazrpam C 22-Feb-2006 08:20 AM Page: 349 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Timolol C Date:12/29/98ISR Number: 3176503-7Report Type:Expedited (15-DaCompany Report #JAUSA-35445 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Risperdal Initial or Prolonged Phosphokinase Increased Professional (Risperidone) PS Janssen ORAL 2 MG 2 DAILY Catatonia ORAL Muscle Rigidity Haldol (Haloperidol) SS Janssen INTRAMUSCULAR PRN Neuroleptic Malignant INTRAMUSCULAR Syndrome Pneumonia Pyrexia Rhabdomyolysis Urinary Tract Infection Date:12/29/98ISR Number: 3176504-9Report Type:Expedited (15-DaCompany Report #JAKYO-41608 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Risperidone PS Janssen ORAL 2 MG DAILY Blood Urea Decreased Health ORAL Chest X-Ray Abnormal Professional Haloperidol Depressed Level Of (Haloperidol) C Consciousness Brotizolam Immune System Disorder (Brotizolam) C Malnutrition Sodium Valproate Pneumonia (Valproate Sodium) C Pyrexia Subarachnoid Haemorrhage White Blood Cell Count Increased Date:12/29/98ISR Number: 3176505-0Report Type:Expedited (15-DaCompany Report #JAUSA-35464 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Risperdal Initial or Prolonged Inadequate Control Professional (Risperidone) PS Janssen ORAL 3 MG 2 DAILY Diabetic Ketoacidosis ORAL Ketonuria Loxitane (Loxapine) C Zoloft (Sertraline) C Depakote (Valproate Sodium) C Date:12/31/98ISR Number: 3176969-2Report Type:Expedited (15-DaCompany Report #JAUSA-35300 Age:84 YR Gender:Male I/FU:F Outcome PT Death Arrhythmia Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Confusional State Dysphagia Muscle Rigidity Myocardial Infarction 22-Feb-2006 08:20 AM Page: 350 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Pneumonia Report Source Product Role Manufacturer Route Dose Duration Pyrexia Health Risperdal PS Janssen ORAL 1 MG 1 DAILY Weight Decreased Professional ORAL; TAKEN AT BEDTIME; 2 MG TABLET 1 DAILY ORAL 6 MON Date:12/31/98ISR Number: 3177238-7Report Type:Expedited (15-DaCompany Report #980518-008011725 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Study Haloperidol PS ORAL 1 TAB, QD, Initial or Prolonged Diabetes Mellitus Health ORAL Dizziness Professional Riseperidone SS ORAL TAB, QD, Hyperglycaemia ORAL Benztropine C Date:12/31/98ISR Number: 3177510-0Report Type:Expedited (15-DaCompany Report #8-98355-088A Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Foreign Temesta (Lorazepam) PS ORAL 250 MG ONE Initial or Prolonged Overdose Health TIME ORAL Other Suicide Attempt Professional Risperdal Required (Risperidone) Intervention to Tablets SS ORAL 220 MG ONE Prevent Permanent TIME ORAL Impairment/Damage Stablon (Tianeptine) Tablets SS ORAL 500 MG ONE TIME ORAL Teralithe Lp (Lithium) Tablets SS ORAL 28 GRAMS ONE TIME ORAL Stablon C Teralithe Lp C Risperdal C Date:01/05/99ISR Number: 3176743-7Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paranoia Risperidal 1 Mg PS ORAL 1 ORALLY AT Psychotic Disorder BEDTIME 5 DAY Date:01/05/99ISR Number: 3176770-XReport Type:Direct Company Report # Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Respiridone Required Drug Interaction (Janssen) PS Janssen ORAL 3MG ORAL BID; 1 WK Intervention to Hypotonia Loxazepam, Ativan , Prevent Permanent Wyeth-Ayeast SS Wyeth-Ayeast ORAL 1MG ORAL BID 1 WK Impairment/Damage Ativan SS Citraliprm C Celexa C 22-Feb-2006 08:20 AM Page: 351 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/05/99ISR Number: 3177594-XReport Type:Expedited (15-DaCompany Report #JAKYO-41734 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Foreign Risperidone PS Janssen ORAL 2 MG DAILY Anxiety Health ORAL 14 MG Apnoea Professional Levomepromazine Blister Maleate SS ORAL 160 MG DAILY Blood Creatine ORAL Phosphokinase Increased Sulpiride SS ORAL 800 MG DAILY Blood Pressure Decreased ORAL 1.2 G Condition Aggravated DAILY Corneal Reflex Decreased Sodium Valproate C Cyanosis Diazepam C Depressed Level Of Triazolam C Consciousness Flunitrazepam C Diarrhoea Sennoside C Electrocardiogram Carbamazepine C Abnormal Gastric Dilatation Heart Sounds Abnormal Hyperhidrosis Liver Function Test Abnormal Muscle Rigidity Mydriasis Myoglobin Blood Increased Negativism Neuroleptic Malignant Syndrome Pain Rash Erythematous Respiratory Failure Shock Speech Disorder Staring Stupor Suicidal Ideation Ventricular Fibrillation Date:01/05/99ISR Number: 3177596-3Report Type:Expedited (15-DaCompany Report #JAFRA-42291 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Risperdal PS Janssen ORAL 220 MG SINGLE Initial or Prolonged Dysarthria Health ORAL Overdose Professional Tianeptine SS ORAL 500 MG SINGLE ORAL Lorazepam SS ORAL 250 MG SINGLE ORAL FORM:TABLET 2.5 MG Lithium SS ORAL 2800 MG SINGLE ORAL FORM:TABLET 400 MG 22-Feb-2006 08:20 AM Page: 352 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/05/99ISR Number: 3177598-7Report Type:Expedited (15-DaCompany Report #JAKYO-41608 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abscess Bacterial Foreign Risperidone PS Janssen ORAL 2 MG DAILY Anaemia Health ORAL Blood Urea Decreased Professional Haloperidol C Depressed Level Of Brotizolam C Consciousness Sodium Valproate C Immune System Disorder Malnutrition Pneumonia Pneumonia Bacterial Pyrexia Subarachnoid Haemorrhage White Blood Cell Count Increased Date:01/05/99ISR Number: 3177601-4Report Type:Expedited (15-DaCompany Report #JAKYO-41580 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Risperidone PS Janssen ORAL 2 MG DAILY Initial or Prolonged Condition Aggravated Health ORAL Delusion Professional Pimozide C Excitability Haloperidol C Suicidal Ideation Trihexyphenidyl Hydrochloride C Flunitrazepam C Date:01/07/99ISR Number: 3177679-8Report Type:Direct Company Report # Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Doxepin PS Every Day Condition Aggravated Lortab SS Nightmare Clonazepam SS Post-Traumatic Stress Risperidone SS Disorder Suicidal Ideation Thinking Abnormal Date:01/07/99ISR Number: 3177703-2Report Type:Direct Company Report # Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Risperdal PS Janssen .05 MG 9 AM, Initial or Prolonged Pneumonia I MG 9 PM Neupogen C Date:01/07/99ISR Number: 3178004-9Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Atrioventricular Block Risperidone PS ORAL 4MG PO HS First Degree Keflex C Syncope 22-Feb-2006 08:20 AM Page: 353 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/99ISR Number: 3190898-XReport Type:Periodic Company Report #7397312 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Other Abbott - Depakote PS Abbott ORAL 500 MG PO BID Risperdal SS ORAL 4.00 MG PO QD Risperdal C Prolixin C Cogentin C Date:01/11/99ISR Number: 3179805-3Report Type:Expedited (15-DaCompany Report #JAAUS-42033 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Foreign Risperdal Hospitalization - Drug Interaction Health (Risperidone) PS Janssen ORAL 2MG 2 DAILY Initial or Prolonged Respiratory Depression Professional ORAL Methadone (Methadone) Syrup SS ORAL 10 MG 1 DAILY ORAL Date:01/12/99ISR Number: 3179828-4Report Type:Expedited (15-DaCompany Report #990106-008010055 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Haloperidol PS ORAL ORAL Initial or Prolonged Phosphokinase Increased Professional Risperidone SS ORAL ORAL Sinus Tachycardia Temazepam C Lithium Carbonate C Psyllium C Theophylline C Ipratropium Bromide C Date:01/14/99ISR Number: 3180748-XReport Type:Expedited (15-DaCompany Report #JAAUS-42033 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Foreign Risperidone PS Janssen ORAL 3 MG 2 DAILY Hospitalization - Drug Interaction Health ORAL Initial or Prolonged Respiratory Depression Professional Methadone (Methadone) Syrup SS ORAL 10 MG 1 DAILY ORAL Risperidone (Risperidone) SS ORAL 2 MG 2 DAILY ORAL Metoclopramide (Metoclopramide) SS Date:01/14/99ISR Number: 3180750-8Report Type:Expedited (15-DaCompany Report #JAAUS-41725 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperidone PS ORAL 1 MG DAILY Health ORAL Professional Risperidone (Risperidone) SS ORAL 2 MG DAILY ORAL 8 DAY Risperidone 22-Feb-2006 08:20 AM Page: 354 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) SS ORAL 2 MG DAILY ORAL Lithium Carbonate C Venlafaxine C Iron C Coloxyl With Senna C Lactulose C Date:01/14/99ISR Number: 3180752-1Report Type:Expedited (15-DaCompany Report #JAKYO-42597 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Foreign Risperidone PS Janssen Tablet ORAL 2 MG DAILY Health ORAL Professional Risperidone (Risperidone) SS ORAL 4 MG DAILY ORAL 14 DAY Risperidone (Risperidone) SS 2 MG DAILY ORAL 20 DAY Risperidone (Risperidone) SS ORAL 1 MG DAILY ORAL 7 DAY Tiapride Hydrochloride C Amantadine Hydrochloride C Vegetamin-B C Amoxapine C Date:01/14/99ISR Number: 3180753-3Report Type:Expedited (15-DaCompany Report #JASAF-42624 Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Risperidone PS Janssen ORAL 3 MG DAILY Drug Level Below Health ORAL Therapeutic Professional Risperidone SS 0.4 MG/KG/DAY Electrocardiogram Qt Tegretol C Prolonged Epilim C Injury Asphyxiation Melleril C Torsade De Pointes Ritalin C Tofranil C Date:01/14/99ISR Number: 3180754-5Report Type:Expedited (15-DaCompany Report #JAUSA-35739 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Health Risperidone PS Janssen ORAL 1 MG 3 DAILY Initial or Prolonged First Degree Professional ORAL Body Temperature Risperidone Decreased (Risperidone) SS Bradycardia Lasix C Coma Potassium C Eating Disorder Synthroid C Heart Rate Decreased Hypothermia Stupor Ventricular Extrasystoles 22-Feb-2006 08:20 AM Page: 355 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/99ISR Number: 3181928-XReport Type:Expedited (15-DaCompany Report #JAUSA-35390 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Risperdal PS Janssen ORAL .5 MG 1 DAILY Initial or Prolonged Hip Fracture Professional ORAL Muscle Spasms Demerol SS INTRAVENOUS 20 MG SINGLE Pain INTRAVENOUS Respiratory Arrest Lanoxin C Toprol Xl C Diovan C Nitroglycerin C Procardia C Date:01/19/99ISR Number: 3181929-1Report Type:Expedited (15-DaCompany Report #JAUSA-35763 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Osmolarity Health Risperdal PS Janssen ORAL 2 MG 2 DAILY Initial or Prolonged Decreased Professional ORAL Blood Sodium Increased Coma Diabetes Insipidus Nephrogenic Diabetes Insipidus Nervous System Disorder Polyuria Subarachnoid Haemorrhage Date:01/20/99ISR Number: 3182537-9Report Type:Direct Company Report # Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Torticollis Risperdal PS Janssen ORAL 2MG PO BID Lasix C Slow-Mag C Triavil C Mvi C Apap C Mom C Date:01/20/99ISR Number: 3182638-5Report Type:Expedited (15-DaCompany Report #JAKYO-37064 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Risperidal PS Janssen ORAL 6 MG DAILY Phosphokinase Increased Literature ORAL Chromaturia Health Haloperidol Condition Aggravated Professional Decanoate SS Janssen INTRAMUSCULAR 100 MG Confusional State MONTHLY Hallucination INTRAMUSCULAR Hepatic Function Abnormal Biperiden Myalgia Hydrochloride C Pain In Extremity Flunitrazepam C Renal Impairment Diazepam C Rhabdomyolysis 22-Feb-2006 08:20 AM Page: 356 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/99ISR Number: 3183194-8Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Movement Disorder Risperdal PS ORAL SEE IMAGE Restlessness R/O Influence Of Diatropan & Bentyl SS SEE IMAGE 3 WK Date:01/22/99ISR Number: 3184624-8Report Type:Expedited (15-DaCompany Report #JCLAT-42549 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalitis Foreign Risperidone PS ORAL 40 MG SINGLE Initial or Prolonged Overdose Health ORAL Suicide Attempt Professional Date:01/22/99ISR Number: 3184626-1Report Type:Expedited (15-DaCompany Report #JAUSA-35068 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Mitral Valve Prolapse Professional ORAL 3 WK Artane SS ORAL 5 MG 2 DAILY ORAL Cyproheptadine SS ORAL ORAL Serxone C Desyrel C Klonopin C Xanax C Desyrel C Date:01/22/99ISR Number: 3184645-5Report Type:Expedited (15-DaCompany Report #990106-008010055 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Haloperidol PS ORAL ORAL Initial or Prolonged Phosphokinase Increased Professional Placebo SS ORAL ORAL Muscular Weakness Risperidone SS ORAL ORAL Rhabdomyolysis Temazapam C Sinus Tachycardia Lithium Carbonate C Psyllium C Theophylline C Ipratropium Bromide C Benztropeine C Docusate Sodium C Lorazepam C Date:01/25/99ISR Number: 3185396-3Report Type:Expedited (15-DaCompany Report #JAFRA-42695 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal PS Janssen ORAL 4 MG 1 DAILY Initial or Prolonged Phosphokinase Increased ORAL Drug Withdrawal Syndrome Hyperhidrosis Pyrexia Rhabdomyolysis Tremor 22-Feb-2006 08:20 AM Page: 357 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/25/99ISR Number: 3185579-2Report Type:Expedited (15-DaCompany Report #JAUSA-35799 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Health Risperdal PS Janssen ORAL ORAL Initial or Prolonged Akinesia Professional Cocaine SS ORAL ORAL Bowel Sounds Abnormal Marijuana (Opiate Cardiac Murmur Unspec.) SS Complications Of Maternal Benzodiazepines SS Exposure To Therapeutic Depakote C Drugs Zoloft C Cyanosis Ventolin C Grand Mal Convulsion Hyperreflexia Neonatal Complications Of Substance Abuse Pallor Petechiae Date:01/26/99ISR Number: 3186114-5Report Type:Expedited (15-DaCompany Report #980109-008010040 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Haloperidol Initial or Prolonged Increased Literature Decanoate, Aspartate Health Unspecified PS INTRAMUSCULAR 100 MG, Aminotransferase Professional 1X/MO, IM Increased (INTRAMUSCULA Blood Creatine Increased R) Blood Creatine Risperidone SS ORAL 6 MG, QD, Phosphokinase Increased ORAL Blood Urea Increased Biperiden C Chromaturia Flunitrazepam C Movement Disorder Diazepam C Myalgia Pain In Extremity Paralysis Rhabdomyolysis Date:01/27/99ISR Number: 3186960-8Report Type:Expedited (15-DaCompany Report #990121-008010276 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Study Haloperidol PS ORAL 1 TAB, BID , Initial or Prolonged Health ORAL Professional Risperidone SS ORAL 1 TAB, BID, ORAL Propranolol SS ORAL 40 TAB, ORAL Date:01/29/99ISR Number: 3188686-3Report Type:Direct Company Report # Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Health Respiridone PS Initial or Prolonged Professional 22-Feb-2006 08:20 AM Page: 358 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/99ISR Number: 3188717-0Report Type:Direct Company Report # Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Health Risperidone PS ORAL 1 MG BID PO 7 MON Professional Date:02/01/99ISR Number: 3189802-XReport Type:Expedited (15-DaCompany Report #JAUK-41476 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Foreign Risperdal PS Janssen ORAL .5 MG DAILY Fracture Health ORAL 4 DAY Pneumonia Professional Pyelonephritis Date:02/01/99ISR Number: 3189804-3Report Type:Expedited (15-DaCompany Report #JAKYO-42779 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Risperidone PS Janssen ORAL SEE IMAGE Initial or Prolonged Bronchitis Health Trihexiphenidyl Nasopharyngitis Professional Hydrochloride C Pantethine C Amezinii Metylsulfate C Nitrazepam C Mosapramine Hydrochloride C Clarithromycin C Mashi-Nin-Gan C Magnesium Oxide C Date:02/01/99ISR Number: 3189977-2Report Type:Expedited (15-DaCompany Report #JAKYO-41126 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Myeloid Leukaemia Foreign Risperidone PS Janssen ORAL SEE IMAGE Initial or Prolonged Dermatitis Health Haloperidol C Haemoglobin Decreased Professional Pipamperone C Hepatocellular Damage Biperiden Liver Function Test Hydrochloride C Abnormal Pancytopenia Platelet Count Decreased Date:02/01/99ISR Number: 3198520-3Report Type:Periodic Company Report #JAUSA-34545 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal PS ORAL 1 MG 2 DAILY Professional ORAL 22-Feb-2006 08:20 AM Page: 359 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/99ISR Number: 3198522-7Report Type:Periodic Company Report #JAUSA-34667 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Consumer Risperdal PS ORAL ORAL Date:02/01/99ISR Number: 3198525-2Report Type:Periodic Company Report #JAUSA-34783 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Health Risperdal PS ORAL 5MG 1 DAILY Emotional Disorder Professional ORAL Hallucination Headache Date:02/01/99ISR Number: 3198529-XReport Type:Periodic Company Report #JAUSA-35177 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Health Risperdal PS ORAL 1 MG 1 DAILY Fall Professional ORAL Date:02/01/99ISR Number: 3198531-8Report Type:Periodic Company Report #JAUSA-34406 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Health Risperdal PS ORAL .5 MG 2 DAILY Hypoglycaemia Professional ORAL Periactin C Ativan C Doxepin C Betoptic C Date:02/01/99ISR Number: 3395550-3Report Type:Periodic Company Report #M083092 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypertrophy Breast Consumer Desyrel Tabs 50 Mg PS ORAL 50 MG HS ORAL 2 YR Weight Increased Risperdal SS Prozac C Ritalin C Melatonin C Date:02/01/99ISR Number: 3410974-3Report Type:Periodic Company Report #A0072240 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Movement Disorder Health Wellbutrin Professional (Formulation Other Unknown) PS ORAL 150 MG / PER DAY / ORAL Risperidone Tablet SS ORAL .5 MG / TWICE PER DAY / ORAL 22-Feb-2006 08:20 AM Page: 360 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/99ISR Number: 3190250-7Report Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Headache Health Risperdal PS ORAL 3 MG PO BID 2 DAY Professional Date:02/02/99ISR Number: 3190284-2Report Type:Direct Company Report # Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Risperidone PS ORAL 1MG HS PO Intervention to Eye Movement Disorder Prevent Permanent Schizophrenia, Paranoid Impairment/Damage Type Tardive Dyskinesia Date:02/04/99ISR Number: 3191989-XReport Type:Expedited (15-DaCompany Report #JAKYO-42852 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Risperidone PS Janssen ORAL 2 MG DAILY Phosphokinase Increased Health ORAL Eosinophilia Professional Risperidone SS ORAL 3 MG DAILY Gastric Cancer ORAL 9 DAY Hypochloraemia Haloperidol C Hypokalaemia Biperiden Liver Function Test Hydrochloride C Abnormal Nitrazepam C Lymphopenia Flunitrazepam C Neutrophilia Flurazepam Urobilinuria Hydrochloride C Aniracetam C Date:02/04/99ISR Number: 3191991-8Report Type:Expedited (15-DaCompany Report #JAKYO-42895 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Risperidone PS Janssen ORAL 4.5 MG DAILY Initial or Prolonged Health ORAL Professional Levomepromazine Maleate SS ORAL 30 MG DAILY ORAL Teprenone C Flunitrazepam C Amobarbital C Promethazine Hydrochloride C Bromazepam C Sennoside C Date:02/04/99ISR Number: 3191994-3Report Type:Expedited (15-DaCompany Report #JADEN-42225 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Foreign Risperdal Hepatic Function Abnormal (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG DAILY 22-Feb-2006 08:20 AM Page: 361 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Cardil C Panodil C Date:02/04/99ISR Number: 3192152-9Report Type:Direct Company Report # Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening No Adverse Drug Effect Luvox PS (Solvay) ORAL ORAL Other Risperidone SS ORAL Required Lorazepam SS ORAL Intervention to Prevent Permanent Impairment/Damage Date:02/04/99ISR Number: 3298784-1Report Type:Periodic Company Report #M087732 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bradycardia Health Serzone Tabs 50 Mg PS ORAL 50 MG HS ORAL 6 DAY Ventricular Extrasystoles Professional Risperidal SS Buspar C Ativan C Zoloft C Melatonin C Date:02/04/99ISR Number: 3298799-3Report Type:Periodic Company Report #M087754 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Serzone Tabs PS ORAL ORAL Professional Risperidone SS Date:02/04/99ISR Number: 3298803-2Report Type:Periodic Company Report #M087755 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Serzone Tabs PS ORAL ORAL Professional Risperidone SS Date:02/04/99ISR Number: 3301170-9Report Type:Periodic Company Report #M079296 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Serzone Tabs 150 Mg PS ORAL 150 MG BID Chills Professional ORAL Movement Disorder Risperdal SS Pain Valium C Tremor Luvox C Amantadine C 22-Feb-2006 08:20 AM Page: 362 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/99ISR Number: 3303619-4Report Type:Periodic Company Report #M081335 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Serzone Tabs PS ORAL 300 MG QD Professional ORAL Risperidone SS Date:02/05/99ISR Number: 3198954-7Report Type:Periodic Company Report #FLUV002980256 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Luvox Tablets Initial or Prolonged Hypertonia Professional (Fluvoxamine Leukocytosis Maleate) PS ORAL PER ORAL Neuroleptic Malignant Lithium Carbonate Syndrome Capsules (Lithium Pyrexia Carbonate) SS ORAL 300 MG , PER Urinary Incontinence ORAL Risperdal (Risperidone) SS ORAL 4.5 MG , PER ORAL Thorazine (Chlorpromazine Hydrochloride) SS ORAL PER ORAL Effexor C Date:02/08/99ISR Number: 3193382-2Report Type:Direct Company Report # Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Risperdal PS ?OUT PT Dystonia Prozac SS ? OUTPT Date:02/08/99ISR Number: 3193416-5Report Type:Direct Company Report # Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Paxil PS Extrapyramidal Disorder Risperdal SS Date:02/08/99ISR Number: 3193641-3Report Type:Expedited (15-DaCompany Report #JAKYO-42871 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Risperidone PS Janssen ORAL 2 MG DAILY Initial or Prolonged Diarrhoea Health ORAL Enterocolitis Professional Headache Hepatitis Liver Function Test Abnormal Pyrexia White Blood Cell Count Decreased 22-Feb-2006 08:20 AM Page: 363 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/99ISR Number: 3193643-7Report Type:Expedited (15-DaCompany Report #JAUK-42882 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephrotic Syndrome Foreign Risperidone PS Janssen ORAL 2 MG 1 DAILY Initial or Prolonged Systemic Lupus ORAL Erythematosus Paramax C Date:02/08/99ISR Number: 3193753-4Report Type:Direct Company Report # Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Luvox 300mg/Day PS ORAL PO 150MG BID Initial or Prolonged Dystonia PRIOR TO Extrapyramidal Disorder ADMISSION Malaise Risperdal 3mg/Day SS ORAL 1MG TID PO Social Avoidant Behaviour PRIOR TO Tongue Disorder ADMISSION Prilosec C Artificaial Tears & Gentamicin Eye Drops C Date:02/08/99ISR Number: 3194308-8Report Type:Expedited (15-DaCompany Report #990201-008010431 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Mood Foreign Haloperidol Tablets PS ORAL 2 MG, QD, Initial or Prolonged Extrapyramidal Disorder Study ORAL Fatigue Health Risperidone SS ORAL 3 MG, QD, Malaise Professional ORAL/ 2MG Sedation Paroxetine C Suicidal Ideation Lorazepam C Date:02/10/99ISR Number: 3195517-4Report Type:Expedited (15-DaCompany Report #990204-107050809 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Haldol, Tablets Hospitalization - Congestive Professional (Haloperidol) PS ORAL 1) 5 MG, QD, Initial or Prolonged Dyspnoea ORAL 2) Myocardial Infarction 2.5 MG, QD, Oxygen Saturation ORAL Decreased Risperdal Pleural Effusion (Risperidone) SS ORAL 1) .5 MG, Pneumonia BID, ORAL Pulmonary Congestion 2) 1MG, BID, ORAL Benzitropine C Ramipril C Paracetamol C Digoxin C Ipratropium Bromide C Salbutamol C Vitamin C C Calcium Carbonate C Amantadine C Nitrofurantoin C Guaifenesin C 22-Feb-2006 08:20 AM Page: 364 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/12/99ISR Number: 3197944-8Report Type:Expedited (15-DaCompany Report #JAUSA-35335 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Risperdal Hospitalization - Congestive Professional (Risperidone), Initial or Prolonged Condition Aggravated Janssen, Tablet 1 Mg PS Janssen ORAL .5 MG 2 DAILY Dyspnoea Exacerbated ORAL Myocardial Infarction Haldol Oxygen Saturation (Haloperidol), Decreased Janssen, Tablet SS Janssen ORAL .5 MG 1 DAILY Pleural Effusion ORAL Pneumonia Cogentin Pulmonary Congestion (Benztropine) C Respiratory Failure Ramipril (Ramipril) C Acetaminophen (Paracetamol) C Digoxin (Digoxine) C Atrovent (Ipratropium Bromide) C Albuterol (Salbutamol) C Vitamine C (Ascorbic-Acid) C Tums (Ca-Carbonate) C Amantadine (Amantadine) C Macrobid (Nitrofurantoin) C Robitussin (Guaifenesine) C Date:02/15/99ISR Number: 3211359-5Report Type:Periodic Company Report #JAUSA-31844 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Consumer Risperdal (Risperidone) PS Janssen ORAL 3MG 2 DAILY ORAL Valproic Acid C Hydrochlorothiazide C Date:02/15/99ISR Number: 3211365-0Report Type:Periodic Company Report #JAUSA-31847 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Consumer Risperdal Dystonia (Risperidone) PS Janssen ORAL 2MG DAILY Nausea ORAL Pharyngitis Metamucil C Rhinitis Wellbutrin C Date:02/16/99ISR Number: 3199571-5Report Type:Expedited (15-DaCompany Report #JAKYO-42852 Age:67 YR Gender:Male I/FU:F Outcome PT Death Blood Creatine Phosphokinase Increased 22-Feb-2006 08:20 AM Page: 365 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eosinophilia Gastric Cancer Hypochloraemia Report Source Product Role Manufacturer Route Dose Duration Hypokalaemia Foreign Risperidone Liver Function Test Health (Risperidone) PS ORAL 2 MG DAILY Abnormal Professional ORAL Lymphopenia Haloperidol Neutrophilia (Haloperidol) C Urobilinuria Biperiden Hydrochloride (Biperiden Hydrochloride) C Nitrazepam (Nitrazepam) C Flunitrazepam (Flunitrazepam) C Flurazepam Hydrochoride (Flurazepam) C Aniracetam (Aniracetam) C Date:02/16/99ISR Number: 3199583-1Report Type:Expedited (15-DaCompany Report #JAFRA-41715 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Risperdal Hospitalization - Phosphokinase Increased Health (Risperidone), Initial or Prolonged Blood Creatine Professional Janssen, Tablet 2 Mg PS Janssen ORAL 3 MG 2 DAILY Phosphokinase Mb ORAL Increased Loxapac C Catatonia Seresta C Delirium Hyperhidrosis Hypotension Malaise Myoglobin Blood Increased Tachycardia Date:02/16/99ISR Number: 3199587-9Report Type:Expedited (15-DaCompany Report #JAUSA-36070 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Risperdal Initial or Prolonged Lethargy Professional (Risperidone), Sinus Bradycardia Janssen, Tablet PS Janssen ORAL _, ORAL Urinary Tract Infection Zyprexa C Zoloft C Ativan C Date:02/16/99ISR Number: 3199608-3Report Type:Expedited (15-DaCompany Report #JAKYO-43001 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Risperidone PS Janssen ORAL 68 MG SINGLE Initial or Prolonged Health ORAL Professional Trihexyphenidyl Hydrochloride 22-Feb-2006 08:20 AM Page: 366 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Trihexyphenidyl) Tablet SS ORAL 184 MG SINGLE ORAL Sulpiride (Sulpiride) SS ORAL SINGLE ORAL; 31 TABLETS Date:02/16/99ISR Number: 3199677-0Report Type:Expedited (15-DaCompany Report #JAKYO-42999 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bulimia Nervosa Foreign Risperidone Initial or Prolonged Irritability Health (Risperidone), Professional Janssen, Tablet PS Janssen ORAL 2 MG DAILY ORAL Bromazepam C Chlorpromazine Hydrochloride C Etizolam C Brotizolam C Date:02/17/99ISR Number: 3200354-8Report Type:Direct Company Report # Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Depakote PS Abbott ORAL 500MG PO BID 2 DAY Abnormal Risperdal SS Janssen 2MG BID 2 WK White Blood Cell Count Decreased Date:02/17/99ISR Number: 3200523-7Report Type:Expedited (15-DaCompany Report #1999UW00528 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Seroquel PS 600 MG DAILY Initial or Prolonged Blood Creatine Professional Risperdal SS ORAL 4.5 MG QD PO; Phosphokinase Increased 3 MG BID PO Coma Thorazine SS ORAL 3 MG BID PO Confusional State Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Tachycardia Tremor Date:02/18/99ISR Number: 3201075-8Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Liver Function Test Risperdal PS ORAL PO 1MG BID Intervention to Abnormal Depakote SS ORAL PO 375MG BID Prevent Permanent Albuterol Inhale C Impairment/Damage Buspar C 22-Feb-2006 08:20 AM Page: 367 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/99ISR Number: 3201129-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chorea Risperdal PS ORAL UP TO 6MG QD Muscle Twitching PO; SINCE AGE 3 Date:02/18/99ISR Number: 3201338-6Report Type:Direct Company Report # Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Disorientation Risperdal PS 1MG-.05 MG & Faecal Incontinence .02 1/2 MG 20 DAY Date:02/18/99ISR Number: 3203040-3Report Type:Expedited (15-DaCompany Report #JAKYO-42895 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperidone PS Janssen ORAL SEE IMAGE 14 WK Initial or Prolonged Phosphokinase Increased Health Levomepromazine Chromaturia Professional Maleate Decreased Activity (Levomepromazine) Difficulty In Walking Granules SS ORAL 30 MG DAILY Fall ORAL Haematuria Flunitrazepam C Liver Function Test Amobarbital C Abnormal Promethazine Pain In Extremity Hydrochloride C Restlessness Bromazepam C Rhabdomyolysis Sennoside C Sleep Disorder Biperidem Urinary Incontinence Hydrochloride C Date:02/18/99ISR Number: 3203382-1Report Type:Expedited (15-DaCompany Report #JAKYO-43056 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Risperidone Hospitalization - Drowning Health (Risperidone), Initial or Prolonged Professional Janssen, Tablet PS Janssen ORAL 4 MG DAILY ORAL Date:02/18/99ISR Number: 3203399-7Report Type:Expedited (15-DaCompany Report #990209-008010538 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Decreased Foreign Haloperidol PS ORAL 5 MG, QD Intervention to Chest Pain Health Risperidone SS ORAL 4 MG, QD Prevent Permanent Cyanosis Professional Levomepromazine Impairment/Damage Loss Of Consciousness Maleate C Transient Ischaemic Magnesium Oxide C Attack Levoglutamide, Urinary Incontinence Sodium Gualenate C Biperiden Hydrochloride C Rihexyphenidyl Hydrochloride C 22-Feb-2006 08:20 AM Page: 368 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chlorpromazine C Bromperidol C Flunitrazepam C Triazolam C Estazolam C Hydrocyzine C Date:02/18/99ISR Number: 3203402-4Report Type:Expedited (15-DaCompany Report #99USA10177 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Tegretol PS ORAL DAILY, ORAL Initial or Prolonged Drug Interaction Professional Risperdal Tablet 10 Drug Level Below Other Mg (Risperidone) SS ORAL DAILY, ORAL Therapeutic Luvox Tablet C Psychotic Disorder Depakote Tablet C Cogentin Tablet C Date:02/19/99ISR Number: 3202628-3Report Type:Direct Company Report # Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Risperdal PS Janssen ORAL 1 MG PO BID Initial or Prolonged Confusional State Diltiazem C Mental Impairment Glipizide C Restlessness Alprazolam C Nitro Patch C Date:02/19/99ISR Number: 3202650-7Report Type:Direct Company Report # Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradykinesia Risperdal PS Janssen ORAL 1 MG BID PO Initial or Prolonged Decreased Activity Valproic Acid C Other Extrapyramidal Disorder Warfarin C Required Hypokinesia Sotalol C Intervention to Immobile Propoxyphene/Apap C Prevent Permanent Joint Stiffness Benztropine C Impairment/Damage Date:02/22/99ISR Number: 3204835-2Report Type:Expedited (15-DaCompany Report #JAGER-43123 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Systemic Lupus Foreign Risperdal Erythematosus Health (Risperidone), Thrombosis Professional Janssen, Tablet PS Janssen ORAL ORAL Orap (Pimozide), Janssen, Tablet SS Janssen ORAL ORAL Haldol (Haloperidol) SS 22-Feb-2006 08:20 AM Page: 369 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/99ISR Number: 3206484-9Report Type:Expedited (15-DaCompany Report #JAKYO-42871 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Risperidone Initial or Prolonged Ascites Health (Risperidone) PS Janssen ORAL 2 MG DAILY Diarrhoea Professional ORAL Gastroenteritis Viral Headache Hepatitis Hepatomegaly Liver Function Test Abnormal Pyrexia White Blood Cell Count Decreased Date:02/24/99ISR Number: 3206486-2Report Type:Expedited (15-DaCompany Report #JAUK-40753 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Thyroid Stimulating Foreign Risperidal Initial or Prolonged Hormone Decreased Health (Risperidone) PS Janssen ORAL .5 MG 2 DAILY Circulatory Collapse Professional ORAL Hyperthyroidism Digoxin (Digoxine) C Thyroxine Increased Aspirin Tri-Iodothyronine (Acetylsalicylic-Aci Decreased d(Plat Aggr Inh)) C Date:02/24/99ISR Number: 3206488-6Report Type:Expedited (15-DaCompany Report #HOAFF-43183 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperidone Neutropenia Literature (Risperidone) PS Janssen ORAL .5 MG DAILY Health ORAL 3 DAY Professional Zuclopentixol (Zuclopenthixol) C Date:02/25/99ISR Number: 3207339-6Report Type:Periodic Company Report #9839833 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Health Zoloft Tablets PS ORAL 100.00 MG Confusional State Professional TOTAL:DAILY:O RAL Risperdal SS ORAL 1.50 MG TOTAL:DAILY:O RAL Date:02/25/99ISR Number: 3207637-6Report Type:Periodic Company Report #9823529 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Health Zoloft Tablets PS ORAL 200.00 MG Drug Ineffective Professional TOTAL:DAILY:O Face Oedema RAL Risperdal SS ORAL DAILY:ORAL 22-Feb-2006 08:20 AM Page: 370 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depo Estrogen C Date:02/25/99ISR Number: 3207887-9Report Type:Periodic Company Report #9726880 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Consumer Zoloft Tablets PS ORAL Social Problem Ritalin SS ORAL Tenex SS ORAL Risperdal SS ORAL Date:02/25/99ISR Number: 3208129-0Report Type:Expedited (15-DaCompany Report #JAGER-43199 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Foreign Risperdal Hospitalization - Circulatory Collapse Health (Risperidone), Initial or Prolonged Cold Sweat Professional Janssen, Tablet PS ORAL 4 MG DAILY Deep Vein Thrombosis ORAL Dyspnoea Fevarin Pulmonary Embolism (Fluvoxamine) Tablet SS ORAL 50 MG DAILY ORAL/100 MG DAIL ORAL/150 MG DAILY ORAL Amaryl C Bifiteral C Cisday C Isoglaucon-Augentrop fen C Trusopt C Date:02/25/99ISR Number: 3208132-0Report Type:Expedited (15-DaCompany Report #JAKYO-43056 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Risperidone Hospitalization - Drowning Health (Risperidone), Initial or Prolonged Professional Janssen, Tablet PS Janssen ORAL 2-10 MG DAILY ORAL/7-5-4-2 MG 3 WKN Chlorpromazine (Chlorpromazine)- SS ORAL 7.5 MG DAILY ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) SS ORAL 6 MG DAILY ORAL 3 WK Date:02/25/99ISR Number: 3208172-1Report Type:Expedited (15-DaCompany Report #990216-008010659 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Systemic Lupus Foreign Haldol, Unspecified Erythematosus Health (Haloperidol) PS UNKNOWN, Thrombosis Professional UNKNOWN, UNKNOWN 22-Feb-2006 08:20 AM Page: 371 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal (Risperidone) SS ORAL UNKNOWN, UNKNOWN, ORAL Orap (Pimozide) SS ORAL UNKNOWN, UNKNOWN, ORAL Date:02/25/99ISR Number: 3209722-1Report Type:Periodic Company Report #9722554 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Zoloft Tablets PS ORAL 50.00MG TOTAL Headache Health DAILY ORAL Migraine Professional Risperdal SS ORAL 1.00MG TOTAL Pain DAILY ORAL Verapamil C Date:02/25/99ISR Number: 3209899-8Report Type:Periodic Company Report #9826587 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Zoloft Tablets PS ORAL 50.00 MG Diplopia Health TOTAL: DAILY: Professional ORAL Risperdal SS ORAL 1.00 MG TOTAL: DAILY: ORAL Date:02/25/99ISR Number: 3210924-9Report Type:Periodic Company Report #JAUSA-31751 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Risperdal PS Janssen ORAL 2 MG 2 DAILY Hospitalization - Suicide Attempt Professional ORAL Initial or Prolonged Aspirin (Acetylsalicylic-Aci d) SS ORAL 325 MG SINGLE ORAL Date:02/25/99ISR Number: 3210930-4Report Type:Periodic Company Report #JAUSA-31753 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Weight Increased Professional ORAL Prozac C Date:02/25/99ISR Number: 3210943-2Report Type:Periodic Company Report #JAUSA-31756 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epistaxis Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Professional ORAL Theo-Dur C Neurontin C 22-Feb-2006 08:20 AM Page: 372 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3210951-1Report Type:Periodic Company Report #JAUSA-31757 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Risperdal PS Janssen ORAL -, ORAL Increased Professional Aspartate Aminotransferase Increased Date:02/25/99ISR Number: 3210955-9Report Type:Periodic Company Report #JAUSA-31758 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Risperdal PS Janssen ORAL 2 MG DAILY Oedema Peripheral Professional ORAL Fastin C Klonopin C Lasix C Prozac C Tegretol C Pondimin C Date:02/25/99ISR Number: 3210961-4Report Type:Periodic Company Report #JAUSA-31759 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Consumer Risperdal PS Janssen ORAL 4 MG DAILY Fungal Infection ORAL; 3 MG Hypoaesthesia DAILY; 2.5 MG Pollakiuria DAILY ORAL 11 MON Urinary Incontinence Lithium C Calcium C Synthroid C Lotrisone C Date:02/25/99ISR Number: 3210967-5Report Type:Periodic Company Report #JAUSA-31768 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Torticollis Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3210971-7Report Type:Periodic Company Report #JAUSA-31769 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sensory Disturbance Consumer Risperdal PS Janssen ORAL -, 2 DAILY ORAL Date:02/25/99ISR Number: 3210977-8Report Type:Periodic Company Report #JAUSA-31774 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Professional ORAL 22-Feb-2006 08:20 AM Page: 373 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3210980-8Report Type:Periodic Company Report #JUSA-31776 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal Professional (Risperidone) PS Janssen ORAL -, ORAL Date:02/25/99ISR Number: 3210986-9Report Type:Periodic Company Report #JAUSA-31779 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Flushing Health Risperdal Professional (Risperidone) PS Janssen ORAL -, ORAL Date:02/25/99ISR Number: 3210990-0Report Type:Periodic Company Report #JAUSA-31781 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 6 MG 1 DAILY ORAL;4.5 MG 1 DAILY;3 MG 1 DAILY 5 WK Propulsid C Tegretol C Synthroid C Prozac C Claritin-D C Calcium C Estrogens Unspec C Cytotec C Fibrocol C Vitamins C Date:02/25/99ISR Number: 3210996-1Report Type:Periodic Company Report #JAUSA-31787 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Consumer Risperdal (Risperidone) PS Janssen ORAL 3 MG DAILY ORAL Cogentin C Date:02/25/99ISR Number: 3211002-5Report Type:Periodic Company Report #JAUSA-31790 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal PS Janssen ORAL 4 MG DAILY Deficit/Hyperactivity Professional ORAL; 2 MON Disorder Condition Aggravated 22-Feb-2006 08:20 AM Page: 374 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3211007-4Report Type:Periodic Company Report #JAUSA-31834 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Consumer Risperdal Initial or Prolonged Phosphokinase Increased (Risperidone) PS Janssen ORAL -, DAILY ORAL Chest Pain Neurontin C Paxil C Tenormin C Date:02/25/99ISR Number: 3211012-8Report Type:Periodic Company Report #JAUSA-31835 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Risperdal Initial or Prolonged Medication Error Health (Risperidone) PS Janssen ORAL 3 MG DAILY Psychotic Disorder Professional ORAL Haldol (Haloperidol) SS Janssen ORAL 3 MG DAILY ORAL Date:02/25/99ISR Number: 3211019-0Report Type:Periodic Company Report #JAUSA-31838 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Health Risperdal Oedema Professional (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL; 2 MG 1 DAILY Prolixin C Date:02/25/99ISR Number: 3211024-4Report Type:Periodic Company Report #JAUSA-31839 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epistaxis Consumer Risperdal Rhinitis (Risperidone) PS Janssen ORAL 1.5 MG DAILY Sedation ORAL; 0.5 MG Sinusitis AT 3 PM AND 1 MG 8 PM. Cylert C Triaminic C Antibiot. Unspec C Date:02/25/99ISR Number: 3211042-6Report Type:Periodic Company Report #JAUSA-31840 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Risperdal Professional (Risperidone) PS Janssen ORAL 6 MG 1 DAILY ORAL Klonopin C Docusate C Cytptec C 22-Feb-2006 08:20 AM Page: 375 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3211048-7Report Type:Periodic Company Report #JAUSA-31841 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Dreams Consumer Risperdal Insomnia (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL Donnatal C Lotensin C Premarin C Xanax C Synthroid C Remeron C Navane C Date:02/25/99ISR Number: 3211068-2Report Type:Periodic Company Report #JAUSA-31395 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Weight Increased Professional (Risperidone) PS Janssen ORAL TABLET, 1 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3211073-6Report Type:Periodic Company Report #JAUSA-31397 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glaucoma Consumer Risperdal (Risperidone) PS Janssen ORAL 1.5 MG 1 DAILY ORAL Cardizem C Atenolol C Date:02/25/99ISR Number: 3211079-7Report Type:Periodic Company Report #JAUSA-31398 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Emotional Disorder Consumer Risperdal Nervousness (Risperidone) PS Janssen ORAL SEE IMAGE Therapeutic Response Ativan C Decreased Desipramine C Tremor Date:02/25/99ISR Number: 3211090-6Report Type:Periodic Company Report #JAUSA-31399 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, ORAL Date:02/25/99ISR Number: 3211095-5Report Type:Periodic Company Report #JAUSA-31401 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone) PS Janssen ORAL .5 MG 1 DAILY ORAL 22-Feb-2006 08:20 AM Page: 376 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paxil C Klonopin C Mevacor C Date:02/25/99ISR Number: 3211102-XReport Type:Periodic Company Report #JAUSA-31424 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Health Risperdal Initial or Prolonged Deficit/Hyperactivity Professional (Risperidone) PS Janssen ORAL TABLET, 3 MG Disorder 2 DAILY ORAL 2 WK Neuroleptic Malignant Zoloft C Syndrome Date:02/25/99ISR Number: 3211109-2Report Type:Periodic Company Report #JAUSA-31427 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL TABLET, 3 MG 2 DAILY ORAL Depakote C Date:02/25/99ISR Number: 3211114-6Report Type:Periodic Company Report #JAUSA-31431 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, 2 DAILY ORAL Haldol C Bumex C Ativan C Date:02/25/99ISR Number: 3211122-5Report Type:Periodic Company Report #JAUSA-31434 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, 6 MG 1 DAILY ORAL Proventil C Date:02/25/99ISR Number: 3211127-4Report Type:Periodic Company Report #JAUSA-31437 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apnoea Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, ORAL 2 DAY 22-Feb-2006 08:20 AM Page: 377 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3211131-6Report Type:Periodic Company Report #JAUSA-31438 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Risperdal Bronchitis Professional (Risperidone) PS Janssen ORAL TABLET, 6MG 1 Drug Level Above DAILY ORAL Therapeutic Lithium C Extrapyramidal Disorder Erythromycin C Salivary Hypersecretion Date:02/25/99ISR Number: 3211138-9Report Type:Periodic Company Report #JAUSA-31439 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Risperdal Aphasia Professional (Risperidone) PS Janssen ORAL 3MG 2 DAILY Breath Odour ORAL Constipation Antihypertensive Depression Agents C Faeces Discoloured Insomnia Myalgia Oedema Peripheral Orthostatic Hypotension Skin Discolouration Thinking Abnormal Date:02/25/99ISR Number: 3211148-1Report Type:Periodic Company Report #JAUSA-31440 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Risperdal Dystonia Professional (Risperidone) PS Janssen SEE IMAGE Sinusitis Biaxin Therapeutic Response (Clarithromycin) SS Decreased Date:02/25/99ISR Number: 3211154-7Report Type:Periodic Company Report #JAUSA-31442 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Consumer Risperdal Muscle Contractions (Rispeidone) PS Janssen ORAL 1 MG 2 DAILY Involuntary ORAL Date:02/25/99ISR Number: 3211159-6Report Type:Periodic Company Report #JAUSA-31443 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Jansen ORAL TABLET, 4 MG 2 DAILY ORAL Clozapine C Depakote C Verapamil C Cimetidine C Clonazepam C 22-Feb-2006 08:20 AM Page: 378 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insulin C Date:02/25/99ISR Number: 3211165-1Report Type:Periodic Company Report #JAUSA-31445 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Risperdal Coordination Abnormal (Risperidone) PS Janssen ORAL 3 MG 2 DAILY Salivary Hypersecretion ORAL Suicide Attempt Luvox C Urinary Incontinence Klonopin C Date:02/25/99ISR Number: 3211172-9Report Type:Periodic Company Report #JAUSA-31447 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Consumer Risperdal Initial or Prolonged Drug Effect Decreased (Risperidone) PS Janssen SEE IMAGE Headache Hyperhidrosis Vomiting Date:02/25/99ISR Number: 3211176-6Report Type:Periodic Company Report #JAUSA-31448 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal Initial or Prolonged Fatigue (Risperidone) PS Janssen SEE IMAGE Insomnia Effexor C Sedation Effexor C Tremor Weight Increased Date:02/25/99ISR Number: 3211183-3Report Type:Periodic Company Report #JAUSA-31450 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Faecal Incontinence Health Risperdal Periorbital Oedema Professional (Risperidone) PS Janssen ORAL SEE IMAGE Paxil C Klonopin C Pravachol C Diabeta C Date:02/25/99ISR Number: 3211189-4Report Type:Periodic Company Report #JAUSA-31451 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone) PS Janssen ORAL 3 MG 1 DAILY ORAL 22-Feb-2006 08:20 AM Page: 379 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3211198-5Report Type:Periodic Company Report #JAUSA-31452 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL; 1 MG 2 DAILY ORL 16 WK Zoloft C Ritalin C Date:02/25/99ISR Number: 3211204-8Report Type:Periodic Company Report #JAUSA-31454 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone) PS Janssen ORAL ORAL Mellaril C Date:02/25/99ISR Number: 3211212-7Report Type:Periodic Company Report #JAUSA-31455 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epistaxis Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG 1 DAILY ORAL;4 MG 1 DAILY ORAL 7 DAY Benztropine C Fluoxetine C Carbamazepine C Navane C Date:02/25/99ISR Number: 3211219-XReport Type:Periodic Company Report #JAUSA-31457 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal Decreased Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG 2 DAILY ORAL Paxil C Symmetrel C Vitamin E C Date:02/25/99ISR Number: 3211225-5Report Type:Periodic Company Report #JAUSA-31458 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal Decreased Professional (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Prolixin C 22-Feb-2006 08:20 AM Page: 380 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3211232-2Report Type:Periodic Company Report #JAUSA-31459 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal Decreased Professional (Risperidone) PS Janssen ORAL 7 MG 2 DAILY ORAL Haldol C Clonazepam C Cogentin C Date:02/25/99ISR Number: 3211239-5Report Type:Periodic Company Report #JAUSA-31460 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Tinnitus Professional (Risperidone) PS Janssen ORAL 3 MG 1 DAILY ORAL; 4.5 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3211245-0Report Type:Periodic Company Report #JAUSA-31461 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL Metamucil C Wellbutrin C Date:02/25/99ISR Number: 3211252-8Report Type:Periodic Company Report #JAUSA-31464 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Consumer Risperdal Drug Effect Decreased (Risperidone), Salivary Hypersecretion Janssen, Tablet PS Janssen ORAL 6 MG DAILY ORAL Klonopin C Lithium C Date:02/25/99ISR Number: 3211260-7Report Type:Periodic Company Report #JAUSA-31466 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3211268-1Report Type:Periodic Company Report #JAUSA-31478 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG 1 DAILY ORAL Klonopin C 22-Feb-2006 08:20 AM Page: 381 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paxil C Date:02/25/99ISR Number: 3211274-7Report Type:Periodic Company Report #JAUSA-31479 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Erythematous Consumer Risperdal Sedation (Risperidone) PS Janssen ORAL 8 MG DAILY ORAL Synthroid C Sulindac C Maxzide C Norvasc C Levatol C Date:02/25/99ISR Number: 3211282-6Report Type:Periodic Company Report #JAUSA-31480 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Consumer Risperdal (Risperidone) PS Janssen ORAL 3 MG DAILY ORAL Wellbutrin C Date:02/25/99ISR Number: 3211289-9Report Type:Periodic Company Report #JAUSA-31481 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone) PS Janssen ORAL 1 MG 3 DAILY ORAL Mellaril C Date:02/25/99ISR Number: 3211296-6Report Type:Periodic Company Report #JAUSA-31482 Age:61 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lacrimal Disorder Consumer Risperdal Rhinitis (Risperidone) PS Janssen ORAL 1 MG DAILY ORAL; 4 MG DAILY ORAL 10 WK Zoloft C Date:02/25/99ISR Number: 3211303-0Report Type:Periodic Company Report #JAUSA-31483 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL 22-Feb-2006 08:20 AM Page: 382 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3211307-8Report Type:Periodic Company Report #JAUSA-31485 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Risperdal Sedation Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG DAILY ORAL Date:02/25/99ISR Number: 3211310-8Report Type:Periodic Company Report #JAUSA-31487 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal Deficit/Hyperactivity Professional (Risperidone) PS Janssen ORAL 4 MG DAILY Disorder ORAL Galactorrhoea Cogentin C Hyperprolactinaemia Motrin C Proventil C Date:02/25/99ISR Number: 3211317-0Report Type:Periodic Company Report #JAUSA-31488 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Risperdal Professional (Risperidone) PS Janssen ORAL 3 MG DAILY ORAL; 2 MG DAILY Vitamin E C Date:02/25/99ISR Number: 3211324-8Report Type:Periodic Company Report #JAUSA-31489 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Consumer Risperdal (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL Prozac C Date:02/25/99ISR Number: 3211331-5Report Type:Periodic Company Report #JAUSA-31490 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet PS ORAL 2 MG 1 DAILY Date:02/25/99ISR Number: 3211337-6Report Type:Periodic Company Report #JAUSA-31491 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone), Janssen, Tablet PS ORAL 6 MG DAILY 22-Feb-2006 08:20 AM Page: 383 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3211341-8Report Type:Periodic Company Report #JAUSA-31492 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Risperdal Dyspnoea Professional (Risperidone), Tremor Janssen, Tablet PS ORAL 1.5 MG 2 DAILY Date:02/25/99ISR Number: 3211347-9Report Type:Periodic Company Report #JAUSA-31493 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Consumer Risperdal Dizziness (Risperidone), Insomnia Janssen, Tablet PS ORAL 1 MG 1 DAILY Tremor Luvox (Fluvoxamine) C Levoxyl (Levothyroxine) C Benadryl (Diphenhydramine) C Ambien (Zolpidem) C Vitamin B-12 (Cyanocobalamine) C Date:02/25/99ISR Number: 3211352-2Report Type:Periodic Company Report #JAUSA-31494 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Abnormal Consumer Risperdal Libido Decreased (Risperidone), Janssen, Tablet PS ORAL 6 MG 1 DAILY Zoloft (Sertraline) C Date:02/25/99ISR Number: 3211362-5Report Type:Periodic Company Report #JAUSA-31845 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Consumer Risperdal (Risperidone) PS Janssen ORAL 4MG 2 DAILY ORAL Benztropine C Levothyroxine C Date:02/25/99ISR Number: 3211369-8Report Type:Periodic Company Report #JAUSA-31848 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Galactorrhoea (Risperidone) PS Janssen ORAL 2 MG 1 DAILY Hyperprolactinaemia ORAL Libido Decreased Metamucil (Psyllium) C Wellbutrin (Amfebutamone) C 22-Feb-2006 08:20 AM Page: 384 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3211372-8Report Type:Periodic Company Report #JAUSA-31852 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Consumer Risperdal Gait Disturbance (Risperidone) PS Janssen ORAL 1MG 3 DAILY Menstrual Disorder ORAL Date:02/25/99ISR Number: 3211374-1Report Type:Periodic Company Report #JAUSA-31853 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 3MG 2 DAILY ORAL Date:02/25/99ISR Number: 3211376-5Report Type:Periodic Company Report #JAUSA-31854 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Systemic Lupus Health Risperdal Erythematosus Professional (Risperidone) PS Janssen ORAL 3MG 2 DAILY ORAL Date:02/25/99ISR Number: 3211381-9Report Type:Periodic Company Report #JAUSA-31495 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Consumer Risperdal Weight Increased (Risperidone), Janssen, Tablet 3 Mg PS ORAL 3 MG 2 DAILY Cogentin (Benztropine) C Lithium (Lithium) C Date:02/25/99ISR Number: 3211384-4Report Type:Periodic Company Report #JAUSA-31882 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal (Risperidone) PS Janssen ORAL 3MG 2 DAILY ORAL, 3MG 1 DAILY ORAL Date:02/25/99ISR Number: 3211387-XReport Type:Periodic Company Report #JAUSA-31893 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Risperdal Phosphokinase Increased Professional (Risperidone) PS Janssen ORAL ORAL 22-Feb-2006 08:20 AM Page: 385 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3211388-1Report Type:Periodic Company Report #JAUSA-31496 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Pain Consumer Risperdal Hyperhidrosis (Risperidone), Janssen, Tablet PS ORAL .5 MG 2 DAILY Depakote (Valproate Sodium) C Monopril (Fosinopril) C Lasix (Furosemide) C Date:02/25/99ISR Number: 3211391-1Report Type:Periodic Company Report #JAUSA-31894 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal (Risperidone) PS Janssen ORAL 2MG 2 DAILY ORAL, 3MG 2 DAILY ORAL Date:02/25/99ISR Number: 3211394-7Report Type:Periodic Company Report #JAUSA-31497 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Libido Decreased Health Risperdal Therapeutic Response Professional (Risperidone), Decreased Janssen, Tablet PS ORAL 4 MG DAILY Simethicone (Simethicone (R) ) C Pepcid (Famotidine) C Date:02/25/99ISR Number: 3211395-9Report Type:Periodic Company Report #JAUSA-31895 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Consumer Risperdal (Risperidone) PS Janssen ORAL 2MG 2 DAILY ORAL Date:02/25/99ISR Number: 3211398-4Report Type:Periodic Company Report #JAUSA-31913 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Consumer Risperdal Hallucination (Risperidone) PS Janssen ORAL 6MG DAILY Insomnia ORAL Vomiting Ativan C Date:02/25/99ISR Number: 3211400-XReport Type:Periodic Company Report #JAUSA-31914 Age:42 YR Gender:Male I/FU:I Outcome PT Other Condition Aggravated Delusion Depression 22-Feb-2006 08:20 AM Page: 386 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disturbance In Attention Hallucination Mania Report Source Product Role Manufacturer Route Dose Duration Thinking Abnormal Consumer Risperdal (Risperidone) PS Janssen ORAL 3MG 2 DAILY ORAL Zoloft C Date:02/25/99ISR Number: 3211401-1Report Type:Periodic Company Report #JAUSA-31498 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspartate Health Risperdal Aminotransferase Professional (Risperidone), Increased Janssen, Tablet 4 Mg PS ORAL 4 MG DAILY Date:02/25/99ISR Number: 3211404-7Report Type:Periodic Company Report #JAUSA-31917 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3211406-0Report Type:Periodic Company Report #JAUSA-31500 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal Deficit/Hyperactivity Professional (Risperidone), Disorder Janssen, Tablet PS ORAL 2 MG 2 DAILY Extrapyramidal Disorder Depakote (Valproate Sodium) C Vitamin E (Vitamin E) C Date:02/25/99ISR Number: 3211407-2Report Type:Periodic Company Report #JAUSA-31918 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3211412-6Report Type:Periodic Company Report #JAUSA-31928 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Libido Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3211413-8Report Type:Periodic Company Report #JAUSA-31579 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Risperdal Syndrome Professional (Riseridone), 22-Feb-2006 08:20 AM Page: 387 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Janssen, Tablet PS ORAL 2 DAILY Humulin R (Insulin Rapid Act.) C Nitroderm (Nitroglycerin) C Coumadin (Warfarin) C Date:02/25/99ISR Number: 3211417-5Report Type:Periodic Company Report #JAUSA-31938 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal Deficit/Hyperactivity Professional (Risperidone) PS Janssen ORAL 3MG 1 DAILY Disorder ORAL Date:02/25/99ISR Number: 3211420-5Report Type:Periodic Company Report #JAUSA-31939 Age:97 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vomiting Health Risperdal Professional (Risperidone) PS Janssen ORAL 1MG DAILY ORAL, 1MG ALT DAY ORAL, .5MG DAILY ORAL 26 DAY Prilosec (Omeprazole) SS ORAL 10MG ALT DAY ORAL, 10MG 1 DAILY ORAL Lanoxin C Date:02/25/99ISR Number: 3211421-7Report Type:Periodic Company Report #JAUSA-31594 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Consumer Risperdal (Risperidone), Janssen, Tablet PS ORAL SINGLE Date:02/25/99ISR Number: 3211425-4Report Type:Periodic Company Report #JAUSA-31595 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone), Janssen, Tablet PS ORAL 2 MG 2 DAILY Date:02/25/99ISR Number: 3211428-XReport Type:Periodic Company Report #JAUSA-31940 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pruritus Health Risperdal Rash Erythematous Professional (Risperidone) PS Janssen ORAL 4MG 2 DAILY Weight Increased ORAL 22-Feb-2006 08:20 AM Page: 388 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3211430-8Report Type:Periodic Company Report #JAUSA-31941 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal Visual Disturbance (Risperidone) PS Janssen ORAL 4MG 1 DAILY ORAL Benztropine C Date:02/25/99ISR Number: 3211433-3Report Type:Periodic Company Report #JAUSA-31597 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhinitis Consumer Risperdal (Risperidone), Janssen, Tablet PS ORAL 6 MG DAILY Cogentin (Benztropine) C Lithium (Lithium) C Anafranil (Clomipramine) C Xanax (Alprazolam) C Date:02/25/99ISR Number: 3211438-2Report Type:Periodic Company Report #JAUSA-31598 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Consumer Risperdal Paraesthesia (Risperidone), Janssen, Tablet PS ORAL 3 MG DAILY Glucotrol (Glipizide) C Zoloft (Sertraline) C Levothyroid (Levothyroxine) C Date:02/25/99ISR Number: 3211446-1Report Type:Periodic Company Report #JAUSA-31600 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Risperdal Professional (Risperidone), Janssen, Tablet PS ORAL 4 MG DAILY Date:02/25/99ISR Number: 3211454-0Report Type:Periodic Company Report #JAUSA-31601 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Risperdal Initial or Prolonged Diarrhoea Professional (Risperidone), Gastroenteritis Janssen, Tablet PS ORAL 8 MG 2 DAILY Influenza Like Illness Prozac (Fluoxetine) C Melaena Vomiting 22-Feb-2006 08:20 AM Page: 389 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3211460-6Report Type:Periodic Company Report #JAUSA-31606 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Health Risperdal Professional (Risperidone), Janssen, Tablet PS ORAL 1 MG 2 DAILY Date:02/25/99ISR Number: 3211467-9Report Type:Periodic Company Report #JAUSA-31607 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone), Janssen, Tablet PS ORAL 1 MG DAILY Paxil (Paroxetine) C Depakote (Valproate Sodium) C Date:02/25/99ISR Number: 3211475-8Report Type:Periodic Company Report #JAUSA-31608 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Risperdal Diarrhoea Professional (Risperidone), Janssen, Tablet PS ORAL .5 MG DAILY Oxybutynine (Oxybutnine) C Date:02/25/99ISR Number: 3211486-2Report Type:Periodic Company Report #JAUSA-31611 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paraesthesia Consumer Risperdal PS Janssen ORAL 3MG 2 DAILY ORAL Date:02/25/99ISR Number: 3211492-8Report Type:Periodic Company Report #JAUSA-31625 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Increased Health Risperdal PS Janssen ORAL 50MG SINGLE Initial or Prolonged Fatigue Professional ORAL Hypotension Suicide Attempt Tachycardia Date:02/25/99ISR Number: 3211499-0Report Type:Periodic Company Report #JAUSA-31627 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 1MG 2 DAILY Professional ORAL, 2MG 2 DAILY ORAL 20 DAY Lorazepam C 22-Feb-2006 08:20 AM Page: 390 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3211502-8Report Type:Periodic Company Report #JAUSA-31649 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL ORAL Depression Professional Asendin C Fatigue Suicide Attempt Date:02/25/99ISR Number: 3211505-3Report Type:Periodic Company Report #JAUSA-31684 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Increased Health Risperdal PS Janssen ORAL ORAL Initial or Prolonged Professional Carbamazepine SS Date:02/25/99ISR Number: 3211507-7Report Type:Periodic Company Report #JAUSA-31692 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Health Risperdal PS Janssen ORAL .5MG 2 DAILY Coagulopathy Professional ORAL Drug Interaction Coumadin SS Fall Humulin N C Injury Ativan C Sedation Zoloft C Lanoxin C Date:02/25/99ISR Number: 3211509-0Report Type:Periodic Company Report #JAUSA-31695 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Health Risperdal PS Janssen ORAL 4MG 2 DAILY Paraesthesia Professional ORAL Date:02/25/99ISR Number: 3211512-0Report Type:Periodic Company Report #JAUSA-31697 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL ORAL Professional Date:02/25/99ISR Number: 3211513-2Report Type:Periodic Company Report #JAUSA-31699 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL ORAL Professional Date:02/25/99ISR Number: 3211516-8Report Type:Periodic Company Report #JAUSA-31701 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal PS Janssen ORAL 3MG 2 DAILY Sedation Professional ORAL, 2MG 2 DAILY ORAL, 22-Feb-2006 08:20 AM Page: 391 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1MG 2 DAILY ORAL Effexor C Date:02/25/99ISR Number: 3211519-3Report Type:Periodic Company Report #JAUSA-31702 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nightmare Health Risperdal PS Janssen ORAL 2MG 2 DAILY Professional ORAL Depakote C Lithium C Effexor C Vistaril C Klonopin C Date:02/25/99ISR Number: 3211523-5Report Type:Periodic Company Report #JAUSA-31703 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL ORAL Professional Date:02/25/99ISR Number: 3211528-4Report Type:Periodic Company Report #JAUSA-31705 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Consumer Risperdal PS Janssen ORAL ORAL Effexor C Zoloft C Synthroid C Date:02/25/99ISR Number: 3211534-XReport Type:Periodic Company Report #JAUSA-31706 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL 2MG DAILY Professional ORAL Date:02/25/99ISR Number: 3211541-7Report Type:Periodic Company Report #JAUSA-31708 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL ORAL Professional Date:02/25/99ISR Number: 3211547-8Report Type:Periodic Company Report #JAUSA-31709 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal PS Janssen ORAL 4MG 2 DAILY Galactorrhoea Professional ORAL Hyperprolactinaemia Cogentin C Amantadine C 22-Feb-2006 08:20 AM Page: 392 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3211555-7Report Type:Periodic Company Report #JAUSA-31711 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperidal PS Janssen ORAL 4MG 2 DAILY Professional ORAL Glucophage C Date:02/25/99ISR Number: 3211561-2Report Type:Periodic Company Report #JAUSA-31724 (RSP-113) Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Health Risperdal PS Janssen ORAL 2MG 2 DAILY Professional ORAL Lorazepam C Date:02/25/99ISR Number: 3211568-5Report Type:Periodic Company Report #JAUSA-31738 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal PS Janssen ORAL 2MG 1 DAILY Initial or Prolonged Influenza Like Illness Professional ORAL Date:02/25/99ISR Number: 3211574-0Report Type:Periodic Company Report #JAUSA-31744 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Consumer Risperdal PS Janssen ORAL .5MG 2 DAILY Urinary Retention ORAL Trazodone C Aspirin C Date:02/25/99ISR Number: 3212051-3Report Type:Periodic Company Report #9813811 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Zoloft Tablets PS ORAL 50.00 MG Initial or Prolonged Pyrexia Professional TOTAL:DAILY:O Sedation RAL Risperdal SS ORAL 1.00 MG TOTAL:DAILY:O RAL Buspar C Trazodone C Date:02/25/99ISR Number: 3212074-4Report Type:Periodic Company Report #JAUSA-33111 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Extrapyramidal Disorder Professional (Risperidone), Sedation Janssen Tablet PS Janssen ORAL ORAL Tachycardia Paxil C Cogentin C Sinemet C Zyprexa C 22-Feb-2006 08:20 AM Page: 393 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212077-XReport Type:Periodic Company Report #JAUSA-33112 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Gait Disturbance Professional (Risperidone) Speech Disorder Janssen Tablet PS Janssen ORAL 1 DAILY ORAL Levothyroxine C Cozaar C Ambien C Date:02/25/99ISR Number: 3212080-XReport Type:Periodic Company Report #JAUSA-33113 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Menstrual Disorder Professional (Risperidone) Weight Increased Janssen Tablet PS Janssen ORAL 1MG 2 DAILY ORAL, 1MG 1 DAILY ORAL, .5MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212085-9Report Type:Periodic Company Report #JAUSA-33116 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Risperdal Professional (Risperidone) Janssen Tablet PS Janssen ORAL DAILY ORAL, ESTIMATED START DATE 4.5 TO 4MG / DAY Date:02/25/99ISR Number: 3212099-9Report Type:Periodic Company Report #JAUSA-33118 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal Professional (Risperidone) Janssen Tablet PS Janssen ORAL 1MG DAILY ORAL, 3MG 2 DAILY ORAL Haldol C Clozaril C Date:02/25/99ISR Number: 3212103-8Report Type:Periodic Company Report #JAUSA-33138 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Health Risperdal Initial or Prolonged Inappropriate Professional (Risperidone) Antidiuretic Hormone Janssen Tablet PS Janssen ORAL 6MG 1 DAILY Secretion ORAL Vomiting Naproxen C Isosorbide C Docusate Sodium C 22-Feb-2006 08:20 AM Page: 394 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cimetidine C Clonazepam C Date:02/25/99ISR Number: 3212107-5Report Type:Periodic Company Report #JAUSA-33142 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Consumer Risperdal Fatigue (Risperidone) Osteoarthritis Janssen Tablet 3mg PS Janssen ORAL 3MG 1 DAILY ORAL Sporanox C Cogentin C Naprosyn C Date:02/25/99ISR Number: 3212110-5Report Type:Periodic Company Report #JAUSA-33143 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Consumer Risperdal Disturbance In Attention (Risperidone) Sedation Janssen Tablet 1mg PS Janssen ORAL 2MG 1 DAILY ORAL, 1MG 1 DAILY ORAL Paxil C Date:02/25/99ISR Number: 3212113-0Report Type:Periodic Company Report #JAUSA-33146 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Skin Consumer Risperdal Erectile Dysfunction (Risperidone) Muscle Contractions Janssen Tablet 2mg PS Janssen ORAL 2MG 2 DAILY Involuntary ORAL Date:02/25/99ISR Number: 3212117-8Report Type:Periodic Company Report #JAUSA-33149 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Consumer Risperdal (Risperidone) Janssen Tablet PS Janssen ORAL 2 DAILY ORAL Klonopin C Lithium C Anafranil C Synthroid C Zoloft C Date:02/25/99ISR Number: 3212120-8Report Type:Periodic Company Report #JAUSA-33154 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Priapism Professional (Risperidone) Janssen Tablet PS Janssen ORAL 4MG 2 DAILY ORAL, 3MG 2 22-Feb-2006 08:20 AM Page: 395 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAILY ORAL, 2MG 2 DAILY ORAL 8 DAY Depakote C Date:02/25/99ISR Number: 3212123-3Report Type:Periodic Company Report #JAUSA-33155 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Health Risperdal Initial or Prolonged Aminotransferase Professional (Risperidone) Increased Janssen Tablet PS Janssen ORAL .5MG 2 DAILY Pancreatitis ORAL 2 WK Glynase C Hydrochlorothiazide C Lisinopril C Date:02/25/99ISR Number: 3212126-9Report Type:Periodic Company Report #JAUSA-33170 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Professional (Risperidone) Janssen Tablet PS Janssen ORAL 2MG 2 DAILY ORAL, 3MG 2 DAILY ORAL Date:02/25/99ISR Number: 3212129-4Report Type:Periodic Company Report #JAUSA-33201 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Dyskinesia Professional (Risperidone) Sedation Janssen Tablet PS Janssen ORAL 18MG DAILY ORAL, 17.5MG ORAL Date:02/25/99ISR Number: 3212132-4Report Type:Periodic Company Report #JAUSA-33203 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Flushing (Risperidone) Nightmare Janssen Tablet 3mg PS Janssen ORAL 3MG 1 DAILY Weight Increased ORAL Klonopin C Macrodantin C Vitamin C C Vitamin D C Vitamin E C Naproxen C Lodine C 22-Feb-2006 08:20 AM Page: 396 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212135-XReport Type:Periodic Company Report #JAUSA-33205 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) Janssen Tablet 2mg PS Janssen ORAL 2MG DAILY ORAL AT BEDTIME Potassium C Tenormin C Hydrochlorothiazide C Date:02/25/99ISR Number: 3212138-5Report Type:Periodic Company Report #JAUSA-33206 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pigmentation Disorder Health Risperdal Professional (Risperidone) Janssen Tablet PS Janssen ORAL .5MG 1 DAILY ORAL 3 DAY Date:02/25/99ISR Number: 3212141-5Report Type:Periodic Company Report #JAUSA-33208 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal Professional (Risperidone) Janssen Tablet PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3212144-0Report Type:Periodic Company Report #JAUSA-33209 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Consumer Risperdal Headache (Risperidone) Insomnia Janssen Tablet 1mg PS Janssen ORAL .1 MG SINGLE ORAL Mellaril C Progesterone C Soma C Estrace C Synthroid C Vitamin B C Date:02/25/99ISR Number: 3212147-6Report Type:Periodic Company Report #JAUSA-33210 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Health Risperdal Involuntary Professional (Risperidone) Janssen Tablet PS Janssen ORAL 4MG 1 DAILY ORAL 22-Feb-2006 08:20 AM Page: 397 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212156-7Report Type:Periodic Company Report #JAUSA-34644 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Consumer Risperdal PS ORAL 12 MG 1 Erectile Dysfunction DAILY, ORAL Wellbutrin C Flomax C Tegretol C Date:02/25/99ISR Number: 3212160-9Report Type:Periodic Company Report #JAUSA-34646 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Disorder Health Risperdal Condition Aggravated Professional (Risperidone), Dystonia Janssen, Tablet 1 Mg PS ORAL 3 MG 1 DAILY Extrapyramidal Disorder ORAL Pain Benadryl C Tranxene C Effexor C Restoril C Date:02/25/99ISR Number: 3212164-6Report Type:Periodic Company Report #JAUSA-35340 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Consumer Risperdal Increased (Risperidone), Weight Increased Janssen, Tablet 4 Mg PS ORAL 8 MG, 1 DAILY, ORAL Date:02/25/99ISR Number: 3212168-3Report Type:Periodic Company Report #JAUSA-35342 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal Dyspnoea (Risperidone), Weight Increased Janssen, Tablet 4 Mg PS ORAL 4 MG, 3 DAILY, ORAL Lithium Tablet SS ORAL ORAL Date:02/25/99ISR Number: 3212170-1Report Type:Periodic Company Report #JAUSA-34341 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Consumer Risperdal Extrapyramidal Disorder (Risperidone), Photosensitivity Reaction Janssen, Tablet PS ORAL DAILY, ORAL Risperdal (Risperidone) SS ORAL 1 MG 1 DAILY ORAL Risperdal (Risperidone) SS ORAL 12 MG 1 DAILY ORAL Zoloft (Sertraline) C 22-Feb-2006 08:20 AM Page: 398 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212172-5Report Type:Periodic Company Report #JAUSA-35343 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Metrorrhagia (Risperidone), Janssen, Tablet 1 Mg PS ORAL 1.5 MG 1 DAILY, ORAL Date:02/25/99ISR Number: 3212175-0Report Type:Periodic Company Report #JAUSA-34344 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Consumer Risperdal (Risperidone), Janssen, Solution 2 Mg PS ORAL 2 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212176-2Report Type:Periodic Company Report #JAUSA-35344 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Risperdal Fall Professional (Risperidone), Hypertension Janssen, Tablet 1 Mg PS ORAL 1 MG SINGLE, Orthostatic Hypotension ORAL Tachycardia Ativan C Vomiting Date:02/25/99ISR Number: 3212178-6Report Type:Periodic Company Report #JAUSA-34345 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Hypokinesia (Risperidone), Sedation Janssen, Tablet PS ORAL 6 MG DAILY ORAL Risperdal (Risperidone) SS ORAL 4 MG DAILY ORAL Date:02/25/99ISR Number: 3212179-8Report Type:Periodic Company Report #JAUSA-35348 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Risperdal Hyperprolactinaemia Professional (Risperidone), Laboratory Test Abnormal Janssen, Tablet PS ORAL ORAL Effexor C Date:02/25/99ISR Number: 3212181-6Report Type:Periodic Company Report #JAUSA-34350 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertrichosis Health Risperdal Professional (Risperidone), 22-Feb-2006 08:20 AM Page: 399 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Janssen, Tablet PS ORAL ORAL, PATIENT ONLY HAD TWO DOSES Risperdal (Risperidone) SS Date:02/25/99ISR Number: 3212182-8Report Type:Periodic Company Report #JAUSA-35349 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Risperdal PS ORAL 1 MG, 1 Hypertension Professional DAILY, ORAL Ativan C Remeron C Date:02/25/99ISR Number: 3212184-1Report Type:Periodic Company Report #JAUSA-34351 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Health Risperdal Professional (Risperidone), Janssen , Tablet PS ORAL ORAL Date:02/25/99ISR Number: 3212186-5Report Type:Periodic Company Report #JAUSA-35350 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Risperdal Fatigue (Risperidone), Muscle Contractions Janssen, Tablet 1 Mg PS ORAL .5 MG 2 DAILY Involuntary ORAL Date:02/25/99ISR Number: 3212188-9Report Type:Periodic Company Report #JAUSA-34356 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Risperdal Hyperventilation (Risperidone), Speech Disorder Janssen, Tablet 2 Mg PS ORAL 2 MG 2 DAILY Weight Increased ORAL Risperdal (Risperidone) SS Ritalin (Methylphenidate) C Vancenase (Beclomethasone) C Date:02/25/99ISR Number: 3212190-7Report Type:Periodic Company Report #JAUSA-35351 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal Dyspnoea (Risperidone), Oculogyration Janssen, Tablet 1 Mg PS ORAL 1 MG, 1 DAILY, ORAL Halcion C 22-Feb-2006 08:20 AM Page: 400 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212192-0Report Type:Periodic Company Report #JAUSA-34357 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone), Janssen, Tablet PS ORAL ORAL Olanzapine (Olanzapine) Capsules SS ORAL 10 MG 1 DAILY ORAL Clozaril (Clozapine) SS Date:02/25/99ISR Number: 3212195-6Report Type:Periodic Company Report #JAUSA-35353 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone), Janssen, Tablet 1 Mg PS ORAL 1 MG 1 DAILY, ORAL Date:02/25/99ISR Number: 3212197-XReport Type:Periodic Company Report #JAUSA-34358 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal Professional (Risperidone), Janssen, Tablet PS ORAL 1 MG 2 DAILY ORAL Risperdal (Risperidone) SS 2 MG 2 DAILY ORAL 10 DAY Risperdal (Risperidone) SS ORAL 3 MG 2 DAILY ORAL 6 WK Date:02/25/99ISR Number: 3212198-1Report Type:Periodic Company Report #JAUSA-35362 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Risperdal PS ORAL 2 MG, 2 DAILY, ORAL Lamictal C Date:02/25/99ISR Number: 3212200-7Report Type:Periodic Company Report #JAUSA-34362 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Diabetes Mellitus Professional (Risperidone), Headache Janssen, Tablet PS ORAL 2 MG DAILY Hyperprolactinaemia ORAL Pituitary Tumour Unspecified (Unspecified) SS 22-Feb-2006 08:20 AM Page: 401 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212203-2Report Type:Periodic Company Report #JAUSA-11289 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Asthenia (Risperidone), Depression Janssen, Tablet 3 Mg PS ORAL 3 MG, 2 Erectile Dysfunction DAILY, ORAL Insomnia Nausea Date:02/25/99ISR Number: 3212204-4Report Type:Periodic Company Report #JAUSA-34363 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Health Risperdal Initial or Prolonged Dry Mouth Professional (Risperidone), Dyskinesia Janssen, Tablet 1 Mg PS ORAL 3 MG SINGLE Eye Disorder ORAL Suicide Attempt Risperdal (Risperidone) SS TOOK 3 TABLETS Date:02/25/99ISR Number: 3212207-XReport Type:Periodic Company Report #JAUSA-34365 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Risperdal Initial or Prolonged Drug Effect Increased Professional (Risperidone), Hypotension Janssen, Tablet 2 Mg PS ORAL SINGLE ORAL Suicide Attempt Risperdal Tachycardia (Risperidone) SS TOOK 70-75 TABLETS Date:02/25/99ISR Number: 3212208-1Report Type:Periodic Company Report #JAUSA-20438 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Dizziness (Risperidone), Erectile Dysfunction Janssen, Tablet 1 Mg PS ORAL 1 MG 2 DAILY, Fatigue ORAL Insomnia Date:02/25/99ISR Number: 3212210-XReport Type:Periodic Company Report #JAUSA-34366 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Flushing Consumer Risperdal Myalgia (Risperidone), Sedation Janssen, Tablet 1 Mg PS ORAL .5 MG 1 DAILY ORAL Risperdal (Risperidone) SS ORAL .25 MG 1 DAILY ORAL Risperdal (Risperidone) SS .25 MG 1 DAILY ORAL 22-Feb-2006 08:20 AM Page: 402 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Micronor (Norethisterone) C Date:02/25/99ISR Number: 3212211-1Report Type:Periodic Company Report #JAUSA-26102 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blepharospasm Literature Risperdal Initial or Prolonged Condition Aggravated Health (Risperidone), Dyspnoea Professional Janssen, Tablet PS ORAL .5 MG, DAILY Suicide Attempt ORAL Tardive Dyskinesia Prozac C Tremor Fluvoxamine C Clorazepate C Date:02/25/99ISR Number: 3212212-3Report Type:Periodic Company Report #JAUSA-34368 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypokalaemia Health Risperdal Professional (Risperidone), Janssen, Tablet PS ORAL ORAL Triamterene (Triamterene) C Fludrocortisone (Fludrocortisone) C Date:02/25/99ISR Number: 3212213-5Report Type:Periodic Company Report #JAUSA-27780 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Galactorrhoea Professional (Risperidone), Hyperprolactinaemia Janssen, Tablet PS ORAL 4 MG DAILY, Pituitary Tumour ORAL Haldol (Haloperidol), Janssen, Tablet SS ORAL 20 MG DAILY, ORAL Depo-Provera C Date:02/25/99ISR Number: 3212216-0Report Type:Periodic Company Report #JAUSA-34379 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Risperdal Attention Professional (Risperidone), Deficit/Hyperactivity Janssen, Tablet 3 Mg PS ORAL 1.5 MG 1 Disorder DAILY ORAL, Condition Aggravated 1/2 TABLET Tachycardia TAKEN DAILY, 3MG DAILY Navane (Tiotixene) C Thorazine(Chlorproma zine) C 22-Feb-2006 08:20 AM Page: 403 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212219-6Report Type:Periodic Company Report #JAUSA-28793 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Health Risperdal PS ORAL ORAL Professional Unspecified C Date:02/25/99ISR Number: 3212220-2Report Type:Periodic Company Report #JAUSA-34384 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Risperdal (Risperidone), Janssen Tablet PS ORAL ORAL Haldol (Haloperidol), Janssen SS Date:02/25/99ISR Number: 3212223-8Report Type:Periodic Company Report #JAUSA-34386 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthritis Consumer Risperdal Drug Effect Decreased (Risperidone), Janssen, Tablet 1 Mg PS ORAL 4 MG 1 DAILY ORAL Prempro (Prempro(R)) Tablet .625 Mg SS .625 MG 1 DAILY Risperdal (Risperidone) SS TAKEN AT BEDTIME, ESTIMATED START DATE Prempro (Prempro(R)) SS ONLY TOOK FIVE TABLETS Zoloft (Sertraline) C Lactaid (Tilactase) C Lo-Ovral (Lo-Ovral(R)) C Date:02/25/99ISR Number: 3212224-XReport Type:Periodic Company Report #JAUSA-30315 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Pain Consumer Risperdal Dry Mouth (Risperidone), Gynaecomastia Janssen, Tablet 1 Mg PS ORAL 2 MG 2 DAILY Libido Decreased OTAL Depakote C Tetracycline C Unspecified C 22-Feb-2006 08:20 AM Page: 404 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212227-5Report Type:Periodic Company Report #JAUSA-34392 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Risperdal Initial or Prolonged Professional (Risperidone), Janssen, Tablet 3 Mg PS ORAL 3 MG 1 DAILY ORAL Risperdal (Risperidone) SS ORAL 1.5 MG 1 DAILY ORAL 14 DAY Prozac (Fluoxetine) C Date:02/25/99ISR Number: 3212231-7Report Type:Periodic Company Report #JAUSA-34393 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet 2 Mg PS ORAL 2 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212232-9Report Type:Periodic Company Report #JAUSA-33211 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 4 MG 1 DAILY ORAL Lithium C Date:02/25/99ISR Number: 3212234-2Report Type:Periodic Company Report #JAUSA-34394 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Effect Increased Health Risperdal Suicide Attempt Professional (Risperidone), Janssen, Tablet PS ORAL ORAL Date:02/25/99ISR Number: 3212237-8Report Type:Periodic Company Report #JAUSA-33212 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal Professional (Risperidone), Janssen, Tablet PS ORAL .5 MG 1 DAILY ORAL Zoloft C Date:02/25/99ISR Number: 3212239-1Report Type:Periodic Company Report #JAUSA-34424 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet 2 Mg PS ORAL 2 MG 4 DAILY 22-Feb-2006 08:20 AM Page: 405 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Risperdal (Risperidone) SS ORAL 4 MG 2 DAILY ORAL 1 DAY Risperdal (Risperidone) SS ORAL 2 MG 2 DAILY ORAL 3 DAY Stelazine (Trifluoperazine) C Klonopin (Clonazepam) C Tegretal (Carbamazepine) C Date:02/25/99ISR Number: 3212240-8Report Type:Periodic Company Report #JAUSA-33215 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Consumer Risperdal Sedation (Risperidone), Weight Increased Janssen, Tablet 5 Mg PS Janssen ORAL 5 MG DAILY ORAL Date:02/25/99ISR Number: 3212242-1Report Type:Periodic Company Report #JAUSA-32941 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Myocardial Infarction Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 3.5 MG DAILY ORAL Date:02/25/99ISR Number: 3212244-5Report Type:Periodic Company Report #JAUSA-33217 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperdal Gait Disturbance (Risperidone), Urinary Incontinence Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 2 DAILY ORAL Valproic Acid C Norvasc C Synthroid C Inderal C Axid C Coumadin C Glucophage C Date:02/25/99ISR Number: 3212246-9Report Type:Periodic Company Report #JAUSA-32942 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL .5 MG 1 DAYLY ORAL Klonopin C Pamelor C 22-Feb-2006 08:20 AM Page: 406 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Antihypertensive Agents C Date:02/25/99ISR Number: 3212248-2Report Type:Periodic Company Report #JAUSA-33219 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vulvovaginal Dryness Consumer Risperdal Weight Increased (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG 1 DAILY ORAL GIVEN AT BEDTIME Date:02/25/99ISR Number: 3212249-4Report Type:Periodic Company Report #JAUSA-32943 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Risperdal Initial or Prolonged Oculogyration Professional (Risperidone), Salivary Hypersecretion Janssen, Tablet PS Janssen ORAL 6 MG DAILY ORAL Depakote (Valproate Sodium SS Thorazine (Chlorpromazine) SS ORAL ORAL Date:02/25/99ISR Number: 3212252-4Report Type:Periodic Company Report #JAUSA-32944 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Risperdal Tachycardia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 4.5 MG DAILY ORAL; 3 MG IN AM, 1.5 MG AT BEDTIME Date:02/25/99ISR Number: 3212253-6Report Type:Periodic Company Report #JAUSA-33220 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL .5 MG 1 DAILY ORAL TAKEN AT BEDTIME; 1 MG DAILY; 1 MG 2 DAILY; 1.5 MG 49 WKY Date:02/25/99ISR Number: 3212257-3Report Type:Periodic Company Report #JAUSA-32916 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2.5 MG DAILY 22-Feb-2006 08:20 AM Page: 407 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:02/25/99ISR Number: 3212258-5Report Type:Periodic Company Report #JAUSA-33222 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet PS Tablet ORAL 6 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212260-3Report Type:Periodic Company Report #JAUSA-33225 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3212261-5Report Type:Periodic Company Report #JAUSA-32947 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 3 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212263-9Report Type:Periodic Company Report #JAUSA-33226 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 4 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212264-0Report Type:Periodic Company Report #JAUSA-32949 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 5 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212266-4Report Type:Periodic Company Report #JAUSA-32950 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Consumer Risperdal Paranoia (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL Inderal C Pravachol C 22-Feb-2006 08:20 AM Page: 408 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Restoril C Date:02/25/99ISR Number: 3212267-6Report Type:Periodic Company Report #JAUSA-33227 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal Thinking Abnormal (Risperidone), Visual Disturbance Janssen, Tablet 1 Mg PS Janssen ORAL .5 MG 2 DAILY ORAL; 0.5 MG AT 10:30 PM Pen-Vee K C Date:02/25/99ISR Number: 3212269-XReport Type:Periodic Company Report #JAUSA-32952 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Risperdal Insomnia Professional (Risperidone), Urinary Incontinence Janssen, Tablet 1 Mg PS Janssen ORAL .5 MG 1 DAILY ORAL; TAKEN AT BEDTIME Date:02/25/99ISR Number: 3212270-6Report Type:Periodic Company Report #JAUSA-33230 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Consumer Risperdal (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Dapakote C Date:02/25/99ISR Number: 3212272-XReport Type:Periodic Company Report #JAUSA-32955 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Disorder Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL .5 MG DAILY ORAL 2 DOSES Antihypertensive Agents C Date:02/25/99ISR Number: 3212273-1Report Type:Periodic Company Report #JAUSA-33231 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL .6 MG 2 DAILY ORAL; 1 MG 2 DAILY 3 DAY Aerobid C Albuterol C Nitroglycerin C 22-Feb-2006 08:20 AM Page: 409 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212274-3Report Type:Periodic Company Report #JAUSA-32956 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Flushing Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1.5 MG 2 DAILY ORAL Buspar C Date:02/25/99ISR Number: 3212275-5Report Type:Periodic Company Report #JAUSA-33233 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG 2 DAILY ORAL; 1 MG 2 DAILY ORAL 3 DAY Tegretol C Date:02/25/99ISR Number: 3212276-7Report Type:Periodic Company Report #JAUSA-32957 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Consumer Risperdal (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 1 DAILY ORAL Tiazac C Maxzide C Zocor C Aspirin C Date:02/25/99ISR Number: 3212277-9Report Type:Periodic Company Report #JAUSA-33234 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Consumer Risperdal Speech Disorder (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 2 DAILY ORAL; 1 MG IN THE AM; 1 MG IN THE PM Lithium C Elavil C Potassium C Vitamins C Aspirin C Date:02/25/99ISR Number: 3212278-0Report Type:Periodic Company Report #JAUSA-32958 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Risperdal Abnormal Professional (Risperidone), Weight Increased Janssen, Tablet PS Janssen ORAL 1 MG 1 DAILY ORAL 22-Feb-2006 08:20 AM Page: 410 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoloft C Date:02/25/99ISR Number: 3212279-2Report Type:Periodic Company Report #JAUSA-33235 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Risperdal (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3212280-9Report Type:Periodic Company Report #JAUSA-33236 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Consumer Risperdal Oedema (Risperidone), Osteoarthritis Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG DAILY Tremor ORAL; .5 MG 2 DAILY ORAL Depakoe C Imdur C Coumadin C Glucophage C Axid C Date:02/25/99ISR Number: 3212281-0Report Type:Periodic Company Report #JAUSA-33237 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 3 MG 1 DAILY ORAL; 1.5 MG 1 DAILY ORAL Zoloft C Tenex C Date:02/25/99ISR Number: 3212282-2Report Type:Periodic Company Report #JAUSA-33238 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY ORAL Divalproex Sodium C Date:02/25/99ISR Number: 3212284-6Report Type:Periodic Company Report #JAUSA-33260 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Consumer Risperdal Nausea (Risperidone), Tachycardia Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL; 1Q MG 30 DAY 22-Feb-2006 08:20 AM Page: 411 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212285-8Report Type:Periodic Company Report #JAUSA-33261 Age:5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Consumer Risperdal Vomiting (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1.5 MG 2 DAILY ORAL Propulsid C Carnitor C Zantac C Depakote C Lamictal C Date:02/25/99ISR Number: 3212286-XReport Type:Periodic Company Report #JAUSA-32962 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myalgia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 3 MG 2 DAILY ORAL; 2 MG 2 DAILY ORAL 2 MON Date:02/25/99ISR Number: 3212287-1Report Type:Periodic Company Report #JAUSA-32872 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothermia Health Risperdal Weight Decrease Neonatal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 10 MG 1 DAILY ORAL Paxil (Paroxetine)- SS ORAL 20 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212288-3Report Type:Periodic Company Report #JAUSA-32966 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Consumer Risperdal Tremor (Risperidone), Janssen, Tablet PS Janssen ORAL SEE IMAGE Hydrochlorothiazide C Trazodone C Valproic Acid C Date:02/25/99ISR Number: 3212289-5Report Type:Periodic Company Report #JAUSA-32874 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Libido Decreased Health Risperdal Weight Increased Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG 2 DAILY ORAL Wellbutrin C 22-Feb-2006 08:20 AM Page: 412 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212290-1Report Type:Periodic Company Report #JAUSA-32967 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1.5 MG 1 DAILY ORAL Prozac C Ativan C Date:02/25/99ISR Number: 3212292-5Report Type:Periodic Company Report #JAUSA-32875 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Health Risperdal Sedation Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL;3 MG SINGLE ORAL Depakote C Wellbutrin C Klonopin C Date:02/25/99ISR Number: 3212293-7Report Type:Periodic Company Report #JAUSA-32975 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal Professional (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG DAILY ORAL Date:02/25/99ISR Number: 3212294-9Report Type:Periodic Company Report #JAUSA-32605 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS ORAL 1 MG 1 DAILY Sedation ORAL Tremor Lithium Carbonate Visual Disturbance (Lithium Carbonate) C Weight Increased Synthroid (Levothyroxine) C Contraceptives (Oral Contracept.Unsp) C Cogentin (Benztropine) C Date:02/25/99ISR Number: 3212295-0Report Type:Periodic Company Report #JAUSA-32978 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL .5 MG 2 DAILY ORAL; 1 MG 2 DAILY ORAL 5 DAY 22-Feb-2006 08:20 AM Page: 413 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paxil C Synthroid C Cogentin C Date:02/25/99ISR Number: 3212296-2Report Type:Periodic Company Report #JAUSA-32877 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Syncope Health Risperdal Tongue Oedema Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG SINGLE ORAL Depakote C Date:02/25/99ISR Number: 3212297-4Report Type:Periodic Company Report #JAUSA-32606 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Consumer Risperdal (Risperidone) PS ORAL 3 MG 1 DAILY ORAL Luvox (Fluvoxamine) C Date:02/25/99ISR Number: 3212298-6Report Type:Periodic Company Report #JAUSA-32979 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet 2 Mg PS Janssen 2 MG 2 DAILY ORAL; 3 MG 2 DAILY ORAL 4 DAY Tegretol C Date:02/25/99ISR Number: 3212299-8Report Type:Periodic Company Report #JAUSA-32878 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Consumer Risperdal Pain (Risperidone), Palpitations Janssen, Tablet PS ORAL SEE IMAGE Date:02/25/99ISR Number: 3212301-3Report Type:Periodic Company Report #JAUSA-32608 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Risperdal Neurosis Professional (Risperidone) PS ORAL 1 MG DAILY Nightmare ORAL Rhinitis Depakote (Valproate Weight Increased Sodium) C 22-Feb-2006 08:20 AM Page: 414 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212303-7Report Type:Periodic Company Report #JAUSA-32618 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone) PS ORAL 4 MG DAILY ORAL Lithium (Lithium) C Anafranil (Clomipramine) C Manganese (Manganese) C Date:02/25/99ISR Number: 3212304-9Report Type:Periodic Company Report #JAUSA-32879 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Risperdal Initial or Prolonged Jaundice Professional (Risperidone), Liver Function Test Janssen, Tablet PS Janssen ORAL 1 MG 1 DAILY Abnormal ORAL Vomiting Adderall C Valproic Acid C Date:02/25/99ISR Number: 3212305-0Report Type:Periodic Company Report #JAUSA-32619 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Risperdal Professional (Risperidone) PS ORAL 1 MG DAILY ORAL Prozac (Fluoxetine) C Date:02/25/99ISR Number: 3212306-2Report Type:Periodic Company Report #JAUSA-32961 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myalgia Health Risperdal Professional (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG 2 DAILY ORAL; .5 MG 2 DAILY ORAL 2 WK Lithium C Date:02/25/99ISR Number: 3212307-4Report Type:Periodic Company Report #JAUSA-32621 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Anxiety (Risperidone) PS ORAL 3 MG 2 DAILY Condition Aggravated ORAL Headache Klonopin (Clonazepam) C Remeryl C Tegretol (Carbamazepine) C 22-Feb-2006 08:20 AM Page: 415 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212309-8Report Type:Periodic Company Report #JAUSA-32881 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Nervousness (Risperidone),Jansse Sedation n, Tablet 1 Mg PS Janssen ORAL SEE IMAGE 13 DAY Urinary Incontinence Adderall C Luvox C Date:02/25/99ISR Number: 3212311-6Report Type:Periodic Company Report #JAUSA-32624 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Consumer Risperdal Speech Disorder (Risperidone) PS ORAL ORAL 2 WK Date:02/25/99ISR Number: 3212312-8Report Type:Periodic Company Report #JAUSA-32883 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Risperdal Nausea (Risperidone), Vomiting Janssen, Tablet 1 Mg PS Janssen ORAL SEE IMAGE Date:02/25/99ISR Number: 3212314-1Report Type:Periodic Company Report #JAUSA-32631 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal Speech Disorder Professional (Risperidone) PS ORAL 6 MG 2 DAILY Syncope ORAL Cogentin (Benztropine) C Tegretol (Carbamazepine) C Klonopin (Clonazepam) C Paxil (Paroxetine) C Date:02/25/99ISR Number: 3212316-5Report Type:Periodic Company Report #JAUSA-32886 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Consumer Risperdal Insomnia (Risperidone), Nausea Janssen, Tablet PS Janssen ORAL ORAL Sedation Zantac C Visual Disturbance Aricept C Vomiting Date:02/25/99ISR Number: 3212317-7Report Type:Periodic Company Report #JAUSA-32691 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Dysphagia Professional (Risperidone) PS ORAL DAILY ORAL 22-Feb-2006 08:20 AM Page: 416 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212318-9Report Type:Periodic Company Report #JAUSA-32980 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Extrapyramidal Disorder Professional (Risperidone) PS Janssen ORAL SEE IMAGE Cogentin C Wellbutrin C Bactrim Ds C Date:02/25/99ISR Number: 3212319-0Report Type:Periodic Company Report #JAUSA-32888 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal Orthostatic Hypotension Professional (Risperidone), Janssen, Tablet PS Janssen ORAL SEE IMAGE 11 DAY Dilantin C Ferrous Sulfate C Fludrocortisone C Levothyroxine C Vitamins C Ativan C Date:02/25/99ISR Number: 3212320-7Report Type:Periodic Company Report #JAUSA-32692 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Health Risperdal Initial or Prolonged Stupor Professional (Risperidone) PS ORAL 9 MG DAILY ORAL Date:02/25/99ISR Number: 3212321-9Report Type:Periodic Company Report #JAUSA-32981 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 4 MG 1 DAILY ORAL Eskalith C Date:02/25/99ISR Number: 3212322-0Report Type:Periodic Company Report #JAUSA-32694 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Consumer Risperdal (Risperidone) PS ORAL .5 MG 1 DAILY ORAL Depakote (Valproate Sodium) C Luvox (Fluvoxamine) C Dexedrine (Dexamphetamine) C 22-Feb-2006 08:20 AM Page: 417 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212324-4Report Type:Periodic Company Report #JAUSA-32893 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Risperdal Professional (Risperidone),Jansse n, Tablet PS Janssen ORAL 2.5 MG DAILY, 0.5MG IN AM, 2MG AT BEDTIME. Ativan C Trazodone C Date:02/25/99ISR Number: 3212325-6Report Type:Periodic Company Report #JAUSA-32993 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Consumer Risperdal (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Haldol C Cogentin C Colace C Cimetidine C Date:02/25/99ISR Number: 3212326-8Report Type:Periodic Company Report #JAUSA-32697 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Consumer Risperdal Increased Appetite (Risperidone) PS ORAL 6 MG DAILY Sedation ORAL; 3 MG DAILY ORAL Depakote (Valproate Sodium) C Date:02/25/99ISR Number: 3212328-1Report Type:Periodic Company Report #JAUSA-32894 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Risperdal Drug Level Above Professional (Risperidone), Therapeutic Janssen, Tablet PS ORAL 6 MG DAILY Leukopenia ORAL Carbamazepine C Phenobarbital C Multivit (Multivit (R)) C Ativan C Date:02/25/99ISR Number: 3212329-3Report Type:Periodic Company Report #JAUSA-32698 Age:50 YR Gender:Female I/FU:I Outcome PT Other Agitation Cough Dyspnoea Fatigue 22-Feb-2006 08:20 AM Page: 418 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rhinitis Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal (Risperidone) PS ORAL 1 MG 2 DAILY ORAL; 2 MG 2 DAILY; 2 MG 3 DAILY 25 WK Date:02/25/99ISR Number: 3212330-XReport Type:Periodic Company Report #JAUSA-32995 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Consumer Risperdal Pituitary Tumour (Risperidone) PS Janssen TABLET, 1.5-2MG DAILY Date:02/25/99ISR Number: 3212331-1Report Type:Periodic Company Report #JAUSA-32896 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG 1 DAILY ORAL Zoloft C Date:02/25/99ISR Number: 3212334-7Report Type:Periodic Company Report #JAUSA-33000 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal (Risperidone) PS Janssen ORAL 4.5 MG 1 DAILY ORAL Wellbutrin C Synthroid C Date:02/25/99ISR Number: 3212335-9Report Type:Periodic Company Report #JAUSA-32700 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acne Health Risperdal Professional (Risperidone) PS ORAL .5 MG 2 DAILY ORAL Propulsid (Cisapride) C Navane (Tiotixene) C Zoloft (Sertraline) C Pepcid (Famotidine) C Date:02/25/99ISR Number: 3212337-2Report Type:Periodic Company Report #JAUSA-32897 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone), 22-Feb-2006 08:20 AM Page: 419 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Janssen,Tablet PS Janssen ORAL 3 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212338-4Report Type:Periodic Company Report #JAUSA-32702 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Consumer Risperdal Abdominal Pain (Risperidone) PS ORAL 3 MG 2 DAILY Amenorrhoea ORAL; 3 MG Fatigue DAILY Date:02/25/99ISR Number: 3212339-6Report Type:Periodic Company Report #JAUSA-33006 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Health Risperdal Professional (Risperidone) PS ORAL SEE IMAGE Date:02/25/99ISR Number: 3212341-4Report Type:Periodic Company Report #JAUSA-33010 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Consumer Risperdal Fatigue (Risperidone) PS Janssen ORAL 3MG 2 DAILY ORAL Date:02/25/99ISR Number: 3212343-8Report Type:Periodic Company Report #JAUSA-32703 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal Weight Increased Professional (Risperidone) PS ORAL .5 MG 2 DAILY ORAL Nardil (Phenelzine) C Clonidine (Clonidine) C Trazodone (Trazodone) C Lamictal (Lamotrigine) C Date:02/25/99ISR Number: 3212344-XReport Type:Periodic Company Report #JAUSA-32898 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Professional (Risperidone), Janssen,- PS Janssen ORAL 3 MG 2 DAILY ORAL Ambien C 22-Feb-2006 08:20 AM Page: 420 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212346-3Report Type:Periodic Company Report #JAUSA-33014 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Consumer Risperdal Oedema Peripheral (Risperidone) PS Janssen ORAL 3 MG 2 DAILY Weight Increased ORAL Lorazepam C Cogentin C Date:02/25/99ISR Number: 3212347-5Report Type:Periodic Company Report #JAUSA-32704 Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Risperdal Gait Disturbance Professional (Risperidone) PS ORAL 1.5 MG DAILY Speech Disorder ORAL Amoxicillin (Amoxicillin) SS ORAL ORAL Date:02/25/99ISR Number: 3212348-7Report Type:Periodic Company Report #JAUSA-32899 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Neuroleptic Malignant Professional (Risperidone),Jansse Syndrome n, Tablet PS Janssen ORAL 3 MG DAILY ORAL;6 MG DAILY Date:02/25/99ISR Number: 3212349-9Report Type:Periodic Company Report #JAUSA-33015 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal Initial or Prolonged Tardive Dyskinesia (Risperidone) PS Janssen ORAL SEE IMAGE Urinary Incontinence Prozac C Prozac C Prozac C Prozac C Ambien C Ativan C Theragran C Nicoderm C Date:02/25/99ISR Number: 3212350-5Report Type:Periodic Company Report #JAUSA-32706 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Risperdal Vomiting (Risperidone) PS ORAL .5 MG 1 DAILY ORAL; 2 MG 5 WK Duragesic (Fentanyl) C 22-Feb-2006 08:20 AM Page: 421 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212351-7Report Type:Periodic Company Report #JAUSA-32901 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 3 MG 2 DAILY ORAL Lithium C Depakote C Date:02/25/99ISR Number: 3212352-9Report Type:Periodic Company Report #JAUSA-33023 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Schizoaffective Disorder Professional (Risperidone) PS Janssen ORAL TABLET, 2 MG 2 DAILY ORAL Insulin C Novolin C Catapres C Hydrochlorothiazide C Date:02/25/99ISR Number: 3212355-4Report Type:Periodic Company Report #JAUSA-32709 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Disorder Health Risperdal Initial or Prolonged Hypotension Professional (Risperidone) PS ORAL 1 MG SINGLE ORAL Posicor (Mibefradil) SS Ativan (Lorazepam) C Cardizem (Diltiazem) C Monopril (Fosinopril) C Hydrochlorothiazide (Hydrochlorothiazide ) C Date:02/25/99ISR Number: 3212356-6Report Type:Periodic Company Report #JAUSA-32902 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Libido Decreased Health Risperdal Professional (Risperidone), Janssen,Tablet PS Janssen ORAL 1 MG 2 DAILY ORAL Hydrochlorothiazide C Date:02/25/99ISR Number: 3212357-8Report Type:Periodic Company Report #JAUSA-33025 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Consumer Risperdal (Risperidone) PS Janssen ORAL TABLET, ORAL Zyprexa C Depakote C Milk Of Magnesia C 22-Feb-2006 08:20 AM Page: 422 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212359-1Report Type:Periodic Company Report #JAUSA-32723 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Consumer Risperdal Decreased (Risperidone) PS ORAL 1 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212360-8Report Type:Periodic Company Report #JAUSA-32905 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Health Risperdal Professional (Risperidone),Jansse n, Tablet PS Janssen ORAL SEE IMAGE Mellaril C Date:02/25/99ISR Number: 3212361-XReport Type:Periodic Company Report #JAUSA-33052 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Hepatic Function Abnormal Professional (Risperidone) PS Janssen ORAL Nausea Depakote C Weight Increased Lithium C Date:02/25/99ISR Number: 3212362-1Report Type:Periodic Company Report #JAUSA-33056 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Risperdal Oedema Professional (Risperidone) PS Janssen ORAL SEE IMAGE Prolixin C Date:02/25/99ISR Number: 3212363-3Report Type:Periodic Company Report #JAUSA-32906 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Health Risperdal Professional (Risperidone),Jansse n, Tablet PS Janssen ORAL SEE IMAGE Effexor C Date:02/25/99ISR Number: 3212364-5Report Type:Periodic Company Report #JAUSA-32538 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Risperdal (Risperidone) PS ORAL .5 MG 2 DAILY, ORAL 22-Feb-2006 08:20 AM Page: 423 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212365-7Report Type:Periodic Company Report #JAUSA-33078 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone) PS Janssen ORAL SEE IMAGE Date:02/25/99ISR Number: 3212368-2Report Type:Periodic Company Report #JAUSA-33316 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Condition Aggravated (Risperidone), Mania Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL; .5 MG 1 DAILY ORAL Tranxene C Date:02/25/99ISR Number: 3212369-4Report Type:Periodic Company Report #JAUSA-32540 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone) PS Janssen ORAL 1 MG, 2 DAILY, ORAL Date:02/25/99ISR Number: 3212370-0Report Type:Periodic Company Report #JAUSA-33081 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laryngospasm Health Risperdal Professional (Risperidone) PS Janssen ORAL SEE IMAGE Luvox C Nortriptyline C Date:02/25/99ISR Number: 3212373-6Report Type:Periodic Company Report #JAUSA-33321 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL Paxil C Klonopin C Date:02/25/99ISR Number: 3212374-8Report Type:Periodic Company Report #JAUSA-32541 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Consumer Risperdal Initial or Prolonged Dysphagia (Risperidone) PS Janssen ORAL .5 MG 1 DAILY Muscle Contractions ORAL Involuntary Synthroid C Sedation Vitamin B-12 C Tachycardia Weight Decreased 22-Feb-2006 08:20 AM Page: 424 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212375-XReport Type:Periodic Company Report #JAUSA-33093 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Risperdal Faeces Discoloured Professional (Risperidone) PS Janssen ORAL TABLET, 1.5 MG ORAL Eskalith C Date:02/25/99ISR Number: 3212376-1Report Type:Periodic Company Report #JAUSA-32548 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal (Risperidone) PS Janssen ORAL 3 MG DAILY, ORAL Synthroid C Insulin C Date:02/25/99ISR Number: 3212377-3Report Type:Periodic Company Report #JAUSA-33327 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Leukopenia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG DAILY ORAL Dilantin (Phenytoin) SS Date:02/25/99ISR Number: 3212378-5Report Type:Periodic Company Report #JAUSA-33095 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Schizophrenia Professional (Risperidone) PS Janssen ORAL 2 MG 2 DAILY ORAL Cogentin C Date:02/25/99ISR Number: 3212381-5Report Type:Periodic Company Report #JAUSA-33096 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Risperdal Professional (Risperidone) PS Janssen ORAL SEE IMAGE Artane C Date:02/25/99ISR Number: 3212382-7Report Type:Periodic Company Report #JAUSA-32550 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Consumer Risperdal Personality Disorder (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Clozapine C 22-Feb-2006 08:20 AM Page: 425 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212383-9Report Type:Periodic Company Report #JAUSA-33329 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Risperdal Abnormal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 3 MG DAILY ORAL Zoloft C Date:02/25/99ISR Number: 3212384-0Report Type:Periodic Company Report #JAUSA-33097 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Risperdal Irritability Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL Cogentin C Tegretol C Depakote C Effexor C Klonopin C Synthroid C Maxzide C Date:02/25/99ISR Number: 3212386-4Report Type:Periodic Company Report #JAUSA-32551 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Consumer Risperdal Dysgeusia (Risperidone) PS Janssen ORAL 4 MG, 1 Fall DAILY, ORAL Nausea Parosmia Date:02/25/99ISR Number: 3212388-8Report Type:Periodic Company Report #JAUSA-33331 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Consumer Risperdal (Risperidone), Janssen, Tablet 1mg PS Janssen ORAL SEE IMAGE Benadryl C Date:02/25/99ISR Number: 3212389-XReport Type:Periodic Company Report #JAUSA-33099 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 G 2 DAILY ORAL Xanax C Pamelor C Benadryl C 22-Feb-2006 08:20 AM Page: 426 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212390-6Report Type:Periodic Company Report #JAUSA-32555 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apathy Health Risperdal Professional (Risperidone) PS Janssen ORAL .5 MG 2 DAILY, ORAL Effexor C Date:02/25/99ISR Number: 3212391-8Report Type:Periodic Company Report #JAUSA-33341 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Abnormal Consumer Risperdal (Risperidone), Janssen, Tablet PS Janssen ORAL 3 MG 2 DAILY ORAL ; START DATE ESTIMATED Amitriptyline C Date:02/25/99ISR Number: 3212393-1Report Type:Periodic Company Report #JAUSA-32556 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Consumer Risperdal Menstrual Disorder (Risperidone) PS Janssen ORAL 1 MG 2 DAILY, Weight Increased ORAL Loestrin SS 1, DAILY Date:02/25/99ISR Number: 3212395-5Report Type:Periodic Company Report #JAUSA-33342 Age:47 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Risperdal (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 3 DAILY ORAL ; ESTIMATED START DATE Haldol C Cogentin C Date:02/25/99ISR Number: 3212396-7Report Type:Periodic Company Report #JAUSA-32557 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Consumer Risperdal Convulsion (Risperidone) PS Janssen ORAL 4 MG DAILY Fatigue ORAL Weight Increased Tranxene C 22-Feb-2006 08:20 AM Page: 427 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212397-9Report Type:Periodic Company Report #JAUSA-33345 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL .5 MG 3 DAILY ORAL Date:02/25/99ISR Number: 3212398-0Report Type:Periodic Company Report #JAUSA-32560 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Health Risperdal Professional (Risperidone) PS ORAL 3 GM, 1 DAILY, ORAL Luvox C Date:02/25/99ISR Number: 3212400-6Report Type:Periodic Company Report #JAUSA-32561 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Health Risperdal Involuntary Professional (Risperidone) PS ORAL 3 MG DAILY Purpura ORAL Tremor Xanax C Valium C Ephedrine C Bromfed C Luvox C Serzone C Date:02/25/99ISR Number: 3212402-XReport Type:Periodic Company Report #JAUSA-33346 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperbilirubinaemia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG 2 DAILY ORAL, START DATE PRECEDED CARE WITH PHYSICIAN Depakote C Dexedrine C Date:02/25/99ISR Number: 3212403-1Report Type:Periodic Company Report #JAUSA-32568 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Consumer Risperdal Weight Increased (Risperidone) PS Janssen ORAL 2 MG, 1 DAILY, ORAL Klonopin C 22-Feb-2006 08:20 AM Page: 428 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212405-5Report Type:Periodic Company Report #JAUSA-33354 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Health Risperdal Initial or Prolonged Syncope Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1.5 MG SINGLE ORAL; ONE DOSE Lisinopril C Hydrocholorothiazide C Stelazine C Trazodone C Cogentin C Zoloft C Date:02/25/99ISR Number: 3212407-9Report Type:Periodic Company Report #JAUSA-32570 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ventricular Tachycardia Risperdal Initial or Prolonged (Risperidone) PS Janssen ORAL 1 MG DAILY, ORAL Haldol (Haloperidol) C Date:02/25/99ISR Number: 3212408-0Report Type:Periodic Company Report #JAUSA-33357 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal Oculogyration Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL ; RECEIVED ONLY 2 DAYS Gabitril (Tiagabine) SS Date:02/25/99ISR Number: 3212409-2Report Type:Periodic Company Report #JAUSA-32575 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Health Risperdal Initial or Prolonged Professional (Risperidone) PS Janssen ORAL 2 MG 2 DAILY, ORAL Neurontin C Date:02/25/99ISR Number: 3212411-0Report Type:Periodic Company Report #JAUSA-33358 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Health Risperdal Vaginal Haemorrhage Professional (Risperidone), Janssen, Tablet PS Janssen ORAL -, ORAL; 6 MONTHS 22-Feb-2006 08:20 AM Page: 429 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212412-2Report Type:Periodic Company Report #JAUSA-34445 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothermia Health Risperdal Professional (Risperidone) PS Janssen ORAL 12 MG DAILY ORAL/8 MG DAILY/ 10 MG DAILY ORAL Motrin C Date:02/25/99ISR Number: 3212413-4Report Type:Periodic Company Report #JAUSA-32576 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Risperdal Tremor (Risperidone) PS ORAL 1 MG DAILY ORAL Klonopin C Paxil C Lithium C Verapamil C Lotensin C Cogentin C Date:02/25/99ISR Number: 3212416-XReport Type:Periodic Company Report #JAUSA-32590 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone) PS ORAL 1 MG, 2 DAILY, ORAL Haldol C Date:02/25/99ISR Number: 3212417-1Report Type:Periodic Company Report #JAUSA-32102 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3212418-3Report Type:Periodic Company Report #JAUSA-32597 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY, ORAL Lorazepam C Benztropine C Date:02/25/99ISR Number: 3212419-5Report Type:Periodic Company Report #JAUSA-32105 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nervousness Consumer Risperdal (Risperidone) PS Janssen ORAL 1 MG; 2 22-Feb-2006 08:20 AM Page: 430 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAILY; ORAL Lithium C Tofranil C Date:02/25/99ISR Number: 3212420-1Report Type:Periodic Company Report #JAUSA-32599 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Depakote C Septra C Gabapentin C Date:02/25/99ISR Number: 3212421-3Report Type:Periodic Company Report #JAUSA-32600 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG DAILY, ORAL Serzone C Navane C Date:02/25/99ISR Number: 3212422-5Report Type:Periodic Company Report #JAUSA-32110 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Engorgement Health Risperdal Galactorrhoea Professional (Risperidone) PS Janssen ORAL 1 MG; 1 Hyperprolactinaemia DAILY; ORAL Date:02/25/99ISR Number: 3212424-9Report Type:Periodic Company Report #JAUSA-32602 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Consumer Risperdal Involuntary (Risperidone) PS Janssen ORAL 1 MG 4 DAILY ORAL Thyroid C Cardizem C Inderal C Aspirin C Date:02/25/99ISR Number: 3212425-0Report Type:Periodic Company Report #JAUSA-32111 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Risperdal Insomnia (Risperidone) PS Janssen ORAL 1 MG; 2 DAILY; ORAL Clonidine C 22-Feb-2006 08:20 AM Page: 431 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212426-2Report Type:Periodic Company Report #JAUSA-34446 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone) PS Janssen ORAL 3 MG DAILY ORAL Date:02/25/99ISR Number: 3212427-4Report Type:Periodic Company Report #JAUSA-32112 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3212428-6Report Type:Periodic Company Report #JAUSA-34447 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL ORAL Prozac C Date:02/25/99ISR Number: 3212429-8Report Type:Periodic Company Report #JAUSA-32113 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal Decreased Professional (Risperidone) PS Janssen ORAL 3 MG; 2 DAILY; ORAL Date:02/25/99ISR Number: 3212430-4Report Type:Periodic Company Report #JAUSA-33262 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Consumer Risperdal Hypertonia (Risperidone) PS Janssen ORAL 2 MG 1 DAILY Muscle Contractions ORAL Involuntary Lithium (Lithium) C Urinary Retention Desipramine (Desipramine) C Benadryl (Diphenhydramine) C Date:02/25/99ISR Number: 3212432-8Report Type:Periodic Company Report #JAUSA-32114 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 3 MG; 2 DAILY; ORAL Cogentin C 22-Feb-2006 08:20 AM Page: 432 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212433-XReport Type:Periodic Company Report #JAUSA-34448 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Risperdal Initial or Prolonged Condition Aggravated (Risperidone) PS Janssen ORAL 1 MG 1 DAILY Palpitations ORAL Prozac (Fluoxetine) SS ORAL 20 MG 1 DAILY ORAL Buspar (Buspirone) SS ORAL ORAL Date:02/25/99ISR Number: 3212434-1Report Type:Periodic Company Report #JAUSA-32115 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Extrapyramidal Disorder Professional (Risperidone) PS Janssen ORAL 4 MG DAILY; ORAL Date:02/25/99ISR Number: 3212435-3Report Type:Periodic Company Report #JAUSA-33263 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Consumer Risperdal Antinuclear Antibody (Risperidone) PS Janssen ORAL 1 MG 3 DAILY Positive ORAL Cogentin (Benztropine) C Zoloft (Sertraline) C Ortho-Novum (Ortho-Novum (R)) C Trilafon (Perphenazine) C Date:02/25/99ISR Number: 3212436-5Report Type:Periodic Company Report #JAUSA-33264 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Consumer Risperdal Infection (Risperidone) PS Janssen ORAL .5 MG W DAILY Pruritus ORAL Date:02/25/99ISR Number: 3212437-7Report Type:Periodic Company Report #JAUSA-32116 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Risperdal Condition Aggravated Professional (Risperidone) PS Janssen ORAL 2.5 MG; Delusion DAILY; ORAL Inderal C Date:02/25/99ISR Number: 3212438-9Report Type:Periodic Company Report #JAUSA-33265 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscular Weakness Consumer Risperdal Pain In Extremity (Risperidone) PS Janssen ORAL 1 MG 1 DAILY 22-Feb-2006 08:20 AM Page: 433 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Atenolol (Atenolol) C Aspirin (Acetylsalicylic-Aci d) C Vasotec (Enalapril) C Pravachol (Pravastatin) C Tylenol (Paracetamol) C Nitroglycerin (Nitroglycerin) C Date:02/25/99ISR Number: 3212440-7Report Type:Periodic Company Report #JAUSA-32121 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG; 1 DAILY; ORAL Tegretol C Date:02/25/99ISR Number: 3212442-0Report Type:Periodic Company Report #JAUSA-33266 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hearing Impaired Consumer Risperdal Visual Disturbance (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL Paxil (Paroxetine) C Ativan (Lorazepam) C Date:02/25/99ISR Number: 3212443-2Report Type:Periodic Company Report #JAUSA-34449 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Health Risperdal Lymphadenopathy Professional (Risperidone) PS Janssen ORAL .5 MG 2 DAILY Speech Disorder ORAL Tongue Paralysis Depakote C Clonidine C Date:02/25/99ISR Number: 3212444-4Report Type:Periodic Company Report #JAUSA-33267 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parosmia Consumer Risperdal (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL Timoptic (Timolol) C Date:02/25/99ISR Number: 3212445-6Report Type:Periodic Company Report #JAUSA-32122 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apathy Consumer Risperdal Condition Aggravated (Risperidone) PS Janssen ORAL 6 MG; DAILY; 22-Feb-2006 08:20 AM Page: 434 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Ativan C Date:02/25/99ISR Number: 3212447-XReport Type:Periodic Company Report #JAUSA-33268 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epistaxis Health Risperdal Purpura Professional (Risperidone) PS Janssen OPHTHALMIC .5 MG 2 DAILY Thrombocytopenia ORAL Zoloft (Sertraline) C Date:02/25/99ISR Number: 3212448-1Report Type:Periodic Company Report #JAUSA-34451 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delirium Health Risperdal Urinary Tract Infection Professional (Risperidone) PS Janssen ORAL 3.5 MG 1 DAILY ORAL / 3 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212449-3Report Type:Periodic Company Report #JAUSA-32123 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Fibroadenoma Of Breast (Risperidone) PS Janssen ORAL 2 MG; DAILY; Galactorrhoea ORAL - 4MG DAILY; ORAL - 2 MG DAILY; 94 DAY Tegretol C Klonopin C Serzone C Prozac C Date:02/25/99ISR Number: 3212450-XReport Type:Periodic Company Report #JAUSA-33269 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Extrapyramidal Disorder Professional (Risperidone) PS Janssen ORAL 8 MG DAILY Hyperprolactinaemia ORAL Prozac (Fluoxetine) C Date:02/25/99ISR Number: 3212453-5Report Type:Periodic Company Report #JAUSA-32124 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Condition Aggravated Professional (Risperidone) PS Janssen ORAL 3 MG; 2 Muscular Weakness DAILY; ORAL - 3MG; DAILY; ORAL 4MG DAILY; 4 WK 22-Feb-2006 08:20 AM Page: 435 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212454-7Report Type:Periodic Company Report #JAUSA-34454 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Risperdal Initial or Prolonged Diabetes Mellitus Professional (Risperidone) PS Janssen .5 MG 2 DAILY Tegretol C Date:02/25/99ISR Number: 3212455-9Report Type:Periodic Company Report #JAUSA-33270 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Risperdal Professional (Risperidone) PS Janssen ORAL 2 MG 2 DAILY ORAL Risperdal (Risperidone) SS Janssen ORAL 1 MG 2 DAILY ORAL Paxil (Paroxetine) C Date:02/25/99ISR Number: 3212456-0Report Type:Periodic Company Report #JAUSA-34456 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Risperdal Initial or Prolonged Confusional State Professional (Risperidone) PS Janssen ORAL 4 MG 1 DAILY Thrombocytopenia ORAL Prolixin-Decanoate C Cogentin C Date:02/25/99ISR Number: 3212457-2Report Type:Periodic Company Report #JAUSA-32125 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal Headache (Risperidone) PS Janssen ORAL 2 MG; SINGLE Sedation ORAL Amitriptyline C Date:02/25/99ISR Number: 3212458-4Report Type:Periodic Company Report #JAUSA-33271 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 6 MG DAILY ORAL; 1 MG 1 DAILY; .5 MG 1 DAILY Date:02/25/99ISR Number: 3212461-4Report Type:Periodic Company Report #JAUSA-34465 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Consumer Risperdal (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Buspar (Buspirone) SS ORAL 15 MG 2 DAILY 22-Feb-2006 08:20 AM Page: 436 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:02/25/99ISR Number: 3212462-6Report Type:Periodic Company Report #JAUSA-33272 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3212463-8Report Type:Periodic Company Report #JAUSA-32126 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Risperdal Vomiting (Risperidone) PS Janssen ORAL 2MG; 2 Weight Decreased DAILY; ORAL Date:02/25/99ISR Number: 3212465-1Report Type:Periodic Company Report #JAUSA-33304 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Consumer Risperdal (Risperidone) PS Janssen ORAL 1.5 MG 1 DAILY ORAL Lithium (Lithium) C Paxil (Paroxetine) C Lotensin (Benazepril) C Verapamil (Verapamil) C Date:02/25/99ISR Number: 3212466-3Report Type:Periodic Company Report #JAUSA-34478 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Health Risperdal Involuntary Professional (Risperidone) PS Janssen ORAL .5 MG DAILY ORAL/ .5 MG 2 DAILY ORAL Wellbutrin (Amfebutamone) SS ORAL 150 MG DAILY ORAL/ 100 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212468-7Report Type:Periodic Company Report #JAUSA-32138 Age:11 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematuria Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Ritalin C Lithobid C 22-Feb-2006 08:20 AM Page: 437 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212470-5Report Type:Periodic Company Report #JAUSA-33306 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal Depersonalisation (Risperidone) PS Janssen ORAL 4 MG 1 DAILY Dyspepsia ORAL; 2 MG 1 Sedation DAILY ORAL Tranxene (Clorazepate) C Date:02/25/99ISR Number: 3212471-7Report Type:Periodic Company Report #JAUSA-34481 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone) PS Janssen ORAL 6 MG DAILY ORAL / 12 MG DAILY ORAL 7 MON Depakote C Date:02/25/99ISR Number: 3212472-9Report Type:Periodic Company Report #JAUSA-32140 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal Tremor Professional (Risperidone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3212473-0Report Type:Periodic Company Report #JAUSA-33307 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Salivary Hypersecretion Professional (Risperidone) PS Janssen ORAL 2 MG 1 DAILY Tongue Paralysis ORAL Depakote (Valproate Sodium) C Effexor (Venlafexine) C Klonopin (Clonazepam) C Date:02/25/99ISR Number: 3212474-2Report Type:Periodic Company Report #JAUSA-34489 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperdal Initial or Prolonged Sedation Professional (Risperidone) PS Janssen ORAL .5 MG 1 DAILY Urinary Retention ORAL / 1 MG 2 DAILY ORAL Neurontin C Lanoxin C Trusopt C Timoptic C 22-Feb-2006 08:20 AM Page: 438 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212477-8Report Type:Periodic Company Report #JAUSA-32148 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone) PS Janssen ORAL 3 MG; 2 DAILY; ORAL Date:02/25/99ISR Number: 3212478-XReport Type:Periodic Company Report #JAUSA-33308 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Risperdal Nervousness (Risperidone) PS Janssen ORAL 1 DAILY ORAL Klonopin (Clonazepam) C Lithium (Lithium) C Betapace (Sotalol) C Lanoxin (Digoxine) C Coumadin (Warfarin) C Prevacid (Lansoprazole) C Cogentin (Benztropine) C Date:02/25/99ISR Number: 3212479-1Report Type:Periodic Company Report #JAUSA-34490 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Risperdal Drug Effect Decreased (Risperidone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3212480-8Report Type:Periodic Company Report #JAUSA-32149 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Health Risperdal Involuntary Professional (Risperidone) PS Janssen ORAL ORAL Paraesthesia Date:02/25/99ISR Number: 3212481-XReport Type:Periodic Company Report #JAUSA-33309 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone) PS Janssen ORAL ORAL 6 MON Luvox (Fluvoxamine) C Trazodone (Trazodone) C Ritalin (Methylphenidate) C Relafen (Nabumetone) C 22-Feb-2006 08:20 AM Page: 439 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212482-1Report Type:Periodic Company Report #JAUSA-34492 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL Serzone C Ativan C Date:02/25/99ISR Number: 3212484-5Report Type:Periodic Company Report #JAUSA-32188 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematuria Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3212485-7Report Type:Periodic Company Report #JAUSA-33310 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Orthostatic Hypotension Consumer Risperdal Palpitations (Risperidone) PS Janssen ORAL 1 MG SINGLE Sedation ORAL Date:02/25/99ISR Number: 3212486-9Report Type:Periodic Company Report #JAUSA-34493 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Palpitations Health Risperdal Initial or Prolonged Professional (Risperidone) PS Janssen ORAL 8 MG DAILY ORAL Trilafon C Date:02/25/99ISR Number: 3212487-0Report Type:Periodic Company Report #JAUSA-33311 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Consumer Risperdal (Risperidone) PS Janssen ORAL 2 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3212488-2Report Type:Periodic Company Report #JAUSA-34494 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Health Risperdal Emotional Disorder Professional (Risperidone) PS Janssen ORAL ORAL Headache Paxil (Paroxetine) Hyperhidrosis Tablet SS ORAL ORAL Speech Disorder Clonidine C Visual Disturbance Ritalin C Cogentin C 22-Feb-2006 08:20 AM Page: 440 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212489-4Report Type:Periodic Company Report #JAUSA-32755 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Consumer Risperdal Hypoaesthesia (Risperidone), Oedema Mouth Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY Sedation ORAL Urinary Retention Anafranil C Weight Increased Date:02/25/99ISR Number: 3212491-2Report Type:Periodic Company Report #JAUSA-33313 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Consumer Risperdal (Risperidone) PS Janssen ORAL 2 DAILY ORAL Zoloft (Sertraline) C Artane (Trihexyphenidyl) C Date:02/25/99ISR Number: 3212492-4Report Type:Periodic Company Report #JAUSA-34501 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 2 MG 2 DAILY ORAL / 3 MG 2 DAILY ORAL 28 DAY Klonopin C Depakote C Cogentin C Date:02/25/99ISR Number: 3212493-6Report Type:Periodic Company Report #JAUSA-32798 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Risperdal Professional (Risperidone), Janssen, Tablet .5 Mg PS Janssen ORAL SEE IMAGE Ritalin C Oxybutynine C Imipramine C Date:02/25/99ISR Number: 3212494-8Report Type:Periodic Company Report #JAUSA-33315 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pituitary Tumour Health Risperdal Initial or Prolonged Visual Disturbance Professional (Risperidone) PS Janssen ORAL ORAL 22-Feb-2006 08:20 AM Page: 441 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212496-1Report Type:Periodic Company Report #JAUSA-34502 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 2 MG 2 DAILY ORAL Multivitamin C Thiamine C Date:02/25/99ISR Number: 3212498-5Report Type:Periodic Company Report #JAUSA-32799 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Hallucination Professional (Risperidone), Janssen, Tablet PS Janssen ORAL SEE IMAGE Ritalin C Imipramine C Date:02/25/99ISR Number: 3212499-7Report Type:Periodic Company Report #JAUSA-34507 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Health Risperdal Fatigue Professional (Risperidone) PS Janssen ORAL 3 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212501-2Report Type:Periodic Company Report #JAUSA-34508 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3212503-6Report Type:Periodic Company Report #JAUSA-32800 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Risperdal Initial or Prolonged Hallucination Professional (Risperidone), Janssen, Tablet PS Janssen ORAL SEE IMAGE Ritalin C Prozac C Date:02/25/99ISR Number: 3212504-8Report Type:Periodic Company Report #JAUSA-34510 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Health Risperdal PS ORAL 4 MG 1 DAILY Hypertriglyceridaemia Professional ORAL Laboratory Test Abnormal Zoloft C Depakote C 22-Feb-2006 08:20 AM Page: 442 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212506-1Report Type:Periodic Company Report #JAUSA-34512 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal PS ORAL 3 MG 2 DAILY ORAL Eskalith C Lithonate C Amantadine C Date:02/25/99ISR Number: 3212508-5Report Type:Periodic Company Report #JAUSA-32801 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polyuria Health Risperdal Urinary Incontinence Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG 1 DAILY ORAL Faxil C Date:02/25/99ISR Number: 3212509-7Report Type:Periodic Company Report #JAUSA-34520 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Consumer Risperdal PS ORAL 1 MG 2 DAILY Tremor ORAL Depakote C Artane C Halcion C Date:02/25/99ISR Number: 3212511-5Report Type:Periodic Company Report #JAUSA-34527 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal PS ORAL ORAL Paxil C Date:02/25/99ISR Number: 3212512-7Report Type:Periodic Company Report #JAUSA-32802 Age:9 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Infection Professional (Risperidone), Sedation Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3212514-0Report Type:Periodic Company Report #JAUSA-34529 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pollakiuria Consumer Risperdal PS ORAL .5 MG 2 DAILY ORAL Phenobarbital C Synthroid C 22-Feb-2006 08:20 AM Page: 443 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212516-4Report Type:Periodic Company Report #JAUSA-32803 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cough Health Risperdal Hypertrophy Breast Professional (Risperidone), Laboratory Test Abnormal Janssen, Tablet PS Janssen ORAL .25 MG 2 Muscle Contractions DAILY ORAL Involuntary Luvox C Weight Increased Date:02/25/99ISR Number: 3212517-6Report Type:Periodic Company Report #JAUSA-34533 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Consumer Risperdal PS ORAL 1 MG 1 DAILY Emotional Disorder ORAL Nausea Depakote C Nervousness Weight Increased Date:02/25/99ISR Number: 3212519-XReport Type:Periodic Company Report #JAUSA-32807 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL SEE IMAGE Prozac C Date:02/25/99ISR Number: 3212520-6Report Type:Periodic Company Report #JAUSA-34535 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Risperdal PS ORAL .5 MG 2 DAILY Disturbance In Attention ORAL Speech Disorder Ativan (Lorazepam) SS ORAL ORAL Ambien C Date:02/25/99ISR Number: 3212523-1Report Type:Periodic Company Report #JAUSA-34537 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS ORAL .25 MG 1 Professional DAILY ORAL Risperdal (Risperidone) SS ORAL .5 MG 3 DAILY Date:02/25/99ISR Number: 3212524-3Report Type:Periodic Company Report #JAUSA-32820 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Increased Appetite Consumer Risperdal Libido Increased (Risperidone), Menorrhagia Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 1 DAILY Menstrual Disorder ORAL Inderide C 22-Feb-2006 08:20 AM Page: 444 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212525-5Report Type:Periodic Company Report #JAUSA-34538 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Health Risperdal PS ORAL 6 MG DAILY Skin Discolouration Professional ORAL Tachycardia Hytrin C Weight Increased Vasoretic C Date:02/25/99ISR Number: 3212526-7Report Type:Periodic Company Report #JAUSA-32822 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL SEE IMAGE Tenormin C Prilosec C Cogentin C Date:02/25/99ISR Number: 3212528-0Report Type:Periodic Company Report #JAUSA-34540 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Consumer Risperdal PS ORAL .5 MG 3 DAILY ORAL Buspar C Neurontin C Insulin C Date:02/25/99ISR Number: 3212529-2Report Type:Periodic Company Report #JAUSA-32823 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG 2 DAILY ORAL ; 1 MG 3 DAILY Paxil C Tegretol C Multivitamins C Mom C Date:02/25/99ISR Number: 3212530-9Report Type:Periodic Company Report #JAUSA-34547 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal PS ORAL 3 MG 1 DAILY ORAL Zoloft C 22-Feb-2006 08:20 AM Page: 445 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212532-2Report Type:Periodic Company Report #JAUSA-33445 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Health Risperdal Hypertriglyceridaemia Professional (Risperidone), Laboratory Test Abnormal Janssen, Tablet PS Janssen ORAL ORAL 3 WK Therapeutic Response Depakote C Decreased Lithium C Zoloft C Date:02/25/99ISR Number: 3212533-4Report Type:Periodic Company Report #JAUSA-34577 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Health Risperdal PS ORAL .5 MG 2 DAILY Initial or Prolonged Thrombocytopenia Professional ORAL Zoloft C Synthroid C Inderal C Actigall C Insulin C Date:02/25/99ISR Number: 3212534-6Report Type:Periodic Company Report #JAUSA-32824 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG DAILY ORAL Date:02/25/99ISR Number: 3212536-XReport Type:Periodic Company Report #JAUSA-34604 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal PS ORAL 4 MG 3 DAILY Initial or Prolonged Priapism Professional ORAL Tegretol C Phenobarbital C Date:02/25/99ISR Number: 3212537-1Report Type:Periodic Company Report #JAUSA-32825 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL SEE IMAGE Aspirin C Adalat C Perphenazine C Zoloft C Lorazepam C 22-Feb-2006 08:20 AM Page: 446 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212539-5Report Type:Periodic Company Report #JAUSA-33454 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal PS Janssen ORAL 4 MG 2 DAILY Dyskinesia Professional ORAL/2 MG 2 DAILY ORAL Valium (Diazepam) SS Prozac C Date:02/25/99ISR Number: 3212540-1Report Type:Periodic Company Report #JAUSA-34607 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Risperdal PS ORAL 12 MG DAILY Agitation Professional ORAL Condition Aggravated Luvox (Fluoxamine) Tablet SS ORAL 25 MG DAILY ORAL Date:02/25/99ISR Number: 3212541-3Report Type:Periodic Company Report #JAUSA-32826 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG 1 DAILY ORAL ; IN THE MORNING Asa C Ativan C Verapamil C Stelazine C Dyazide C Lescol C Date:02/25/99ISR Number: 3212542-5Report Type:Periodic Company Report #JAUSA-33458 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Depression Professional (Risperidone), Psychotic Disorder Janssen, Tablet PS Janssen ORAL 6 MG DAILY Weight Increased ORAL/ 4 MG DAILY Zoloft C Date:02/25/99ISR Number: 3212543-7Report Type:Periodic Company Report #JAUSA-34608 Age:67 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS ORAL 10 MG 1 DAILY Professional ORAL 22-Feb-2006 08:20 AM Page: 447 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212544-9Report Type:Periodic Company Report #JAUSA-33466 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Professional ORAL Haloperidol (Haloperidol), Janssen, Ampoule SS Janssen INTRAMUSCULAR INTRAMUSCULAR Date:02/25/99ISR Number: 3212545-0Report Type:Periodic Company Report #JAUSA-32830 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG 2 DAILY ORAL; ESTIMATED DATES Paxil C Adderall C Date:02/25/99ISR Number: 3212546-2Report Type:Periodic Company Report #JAUSA-34625 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal PS ORAL ORAL Professional Date:02/25/99ISR Number: 3212548-6Report Type:Periodic Company Report #JAUSA-33480 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuropathy Peripheral Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL DAILY ORAL/ 2-3 MG DAILY Date:02/25/99ISR Number: 3212549-8Report Type:Periodic Company Report #JAUSA-34637 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Risperdal PS ORAL ORAL Phosphokinase Increased Professional Hypertonia Date:02/25/99ISR Number: 3212550-4Report Type:Periodic Company Report #JAUSA-32850 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperdal (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG 2 DAILY ORAL 22-Feb-2006 08:20 AM Page: 448 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212551-6Report Type:Periodic Company Report #JAUSA-34639 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS ORAL 2 MG 1 DAILY Initial or Prolonged Fatigue ORAL Headache Risperdal Suicide Attempt (Risperidone) SS ORAL 2 MG 1 DAILY Valium C Valproic Acid C Lithium C Unspecified C Date:02/25/99ISR Number: 3212553-XReport Type:Periodic Company Report #JAUSA-33482 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Consumer Risperdal PS Janssen ORAL 2 MG 1 DAILY Phosphokinase Increased ORAL Paxil C Desyrel C Date:02/25/99ISR Number: 3212555-3Report Type:Periodic Company Report #JAUSA-34642 Age:102 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal PS ORAL .5 MG DAILY Drug Abuser ORAL Sedation Risperdal (Risperidone) SS .25 MG TWO TIMES DAILY, 0.5 MG AT BEDTIME Risperdal (Risperidone) SS ORAL 1 MG 1 SINGLE 1 DAY Serax C Aspirin C Lanoxin C Synthroid C Date:02/25/99ISR Number: 3212556-5Report Type:Periodic Company Report #JAUSA-32866 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1MG1 DAILY ORAL; .5 MG 1DAILY Date:02/25/99ISR Number: 3212558-9Report Type:Periodic Company Report #JAUSA-33484 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Consumer Risperdal Dry Mouth (Risperidone), Headache Janssen, Tablet 4 Mg PS Janssen ORAL 4 MG 2 DAILY Weight Increased ORAL 22-Feb-2006 08:20 AM Page: 449 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C Klonopin C Date:02/25/99ISR Number: 3212559-0Report Type:Periodic Company Report #JAUSA-34643 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Consumer Risperdal PS ORAL 2 MG 1 DAILY ORAL Lithium C Premarin C Date:02/25/99ISR Number: 3212560-7Report Type:Periodic Company Report #JAUSA-32869 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 4 MG DAILY ORAL,6 MG DAILY Paxil C Date:02/25/99ISR Number: 3212562-0Report Type:Periodic Company Report #JAUSA-33495 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematemesis Health Risperdal Initial or Prolonged Infection Professional (Risperidone), Melaena Janssen, Tablet PS Janssen ORAL 6 MG DAILY ORAL Date:02/25/99ISR Number: 3212565-6Report Type:Periodic Company Report #JAUSA-32870 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypoaesthesia Consumer Risperdal Tremor (Risperidone), Janssen, Tablet PS Janssen ORAL .5 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212568-1Report Type:Periodic Company Report #JAUSA-33497 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL/5 MG DAILY Paxil C 22-Feb-2006 08:20 AM Page: 450 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212570-XReport Type:Periodic Company Report #JAUSA-32871 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Risperdal Syndrome Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212573-5Report Type:Periodic Company Report #JAUSA-33498 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Drug Ineffective (Risperidone), Psychotic Disorder Janssen, Tablet PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3212575-9Report Type:Periodic Company Report #JAUSA-31943 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3212576-0Report Type:Periodic Company Report #JAUSA-33502 Age:4 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL .5 MG DAILY ORAL 8 WK Date:02/25/99ISR Number: 3212579-6Report Type:Periodic Company Report #JAUSA-31944 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Pain Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3212582-6Report Type:Periodic Company Report #JAUSA-33503 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL Depakote C Zoloft C Prevacid C 22-Feb-2006 08:20 AM Page: 451 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212585-1Report Type:Periodic Company Report #JAUSA-31945 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paraesthesia Health Risperdal Professional (Risperidone) PS Janssen ORAL 5 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212586-3Report Type:Periodic Company Report #JAUSA-33505 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Galactorrhoea (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212587-5Report Type:Periodic Company Report #JAUSA-31946 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Risperdal Professional (Risperidone) PS Janssen ORAL 2 MG 2 DAILY ORAL Zoloft C Vitamins, Unspec C Date:02/25/99ISR Number: 3212590-5Report Type:Periodic Company Report #JAUSA-33507 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Risperdal Aggression Professional (Risperidone), Condition Aggravated Janssen, Tablet PS Janssen ORAL .5 MG 2 DAILY Disturbance In Attention ORAL Depakote C Date:02/25/99ISR Number: 3212592-9Report Type:Periodic Company Report #JAUSA-31947 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 2 MG DAILY ORAL 6 MON Lithium C Synthroid C Date:02/25/99ISR Number: 3212594-2Report Type:Periodic Company Report #JAUSA-33526 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Jaundice Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG DAILY ORAL 22-Feb-2006 08:20 AM Page: 452 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212596-6Report Type:Periodic Company Report #JAUSA-31949 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Consumer Risperdal Deficit/Hyperactivity (Risperidone) PS Janssen ORAL ORAL Disorder Prozac C Dystonia Increased Appetite Date:02/25/99ISR Number: 3212599-1Report Type:Periodic Company Report #JAUSA-33529 Age:77 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3212601-7Report Type:Periodic Company Report #JAUSA-31954 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Urea Increased Health Risperdal Hyperkalaemia Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY Hypochloraemia ORAL Hyponatraemia Benzodiazepines C Diuretics C Date:02/25/99ISR Number: 3212602-9Report Type:Periodic Company Report #JAUSA-33530 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Consumer Risperdal PS Janssen ORAL DAILY ORAL Involuntary Klonopin C Eskalith C Ativan C Synthroid C Date:02/25/99ISR Number: 3212605-4Report Type:Periodic Company Report #JAUSA-31960 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3212607-8Report Type:Periodic Company Report #JAUSA-33544 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Consumer Risperdal PS Jassen ORAL 1.5 MG ORAL Chest Pain Synthroid C 22-Feb-2006 08:20 AM Page: 453 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212608-XReport Type:Periodic Company Report #JAUSA-31964 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone) PS Janssen ORAL UP TO 6 MG DAILY ORAL Date:02/25/99ISR Number: 3212611-XReport Type:Periodic Company Report #JAUSA-33595 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Health Risperdal Abnormal Professional (Risperidone), Electrocardiogram Qt Janssen, Tablet PS Janssen ORAL 2 MG 1 DAILY Prolonged ORAL Date:02/25/99ISR Number: 3212614-5Report Type:Periodic Company Report #JAUSA-31965 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Consumer Risperdal Involuntary (Risperidone) PS Janssen ORAL (SEE IMAGE) DAILY ORAL Paxil C Thyrolar C Lithium C Nortriptyline C Date:02/25/99ISR Number: 3212615-7Report Type:Periodic Company Report #JAUSA-33604 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal PS Janssen ORAL 1.5 MG 3 Professional DAILY ORAL/ 1.5 MG 2 DAILY ORAL Klonopin (Clonazepam) SS ORAL 1 MG 2 DAILY ORAL Paxil C Date:02/25/99ISR Number: 3212618-2Report Type:Periodic Company Report #JAUSA-31970 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Sedation (Risperidone) PS Janssen ORAL (SEE IMAGE) DAILY ORAL Aricept C Thiazid-Comp C Procardia C Levothyroid C Paxil C Klonopin C K-Dur C 22-Feb-2006 08:20 AM Page: 454 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212621-2Report Type:Periodic Company Report #JAUSA-31972 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Ativan (Lorazepam) SS ORAL ORAL Date:02/25/99ISR Number: 3212622-4Report Type:Periodic Company Report #JAUSA-33660 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Drug Withdrawal Syndrome Professional (Risperidone), Nervousness Janssen, Tablet 1 Mg PS ORAL 1.5 MG 1 DAILY ORAL/1 MG 1 DAILY/.5 MG 1 DAILY/.5 MG 1 DAILY 11 WK Diazoxide C Naproxen C Deseril C Glucophage C Proventil C Date:02/25/99ISR Number: 3212625-XReport Type:Periodic Company Report #JAUSA-31974 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Risperdal Hypertonia Professional (Risperidone) PS Janssen ORAL (SEE IMAGE) Pyrexia DAILY ORAL Salivary Hypersecretion Sedation Tachycardia Date:02/25/99ISR Number: 3212628-5Report Type:Periodic Company Report #JAUSA-33667 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL -, 1 DAILY ORAL/ 1 TO 2 MG DAILY Date:02/25/99ISR Number: 3212631-5Report Type:Periodic Company Report #JAUSA-33669 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Libido Decreased Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS ORAL 2 MG 2 DAILY ORAL Lithium C Thyroid Armour C Calcium C 22-Feb-2006 08:20 AM Page: 455 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212633-9Report Type:Periodic Company Report #JAUSA-31978 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Drug Withdrawal Syndrome Professional (Risperidone) PS Janssen ORAL 3 MG 1 DAILY Dystonia ORAL Extrapyramidal Disorder Clarithromycin Sinusitis (Clarithromycin) SS Date:02/25/99ISR Number: 3212634-0Report Type:Periodic Company Report #JAUSA-31981 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Consumer Risperdal (Risperidone) PS Janssen ORAL 1 MG DAILY ORAL Depakote C Coumadin C Lorazepam C Date:02/25/99ISR Number: 3212635-2Report Type:Periodic Company Report #JAUSA-33670 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212636-4Report Type:Periodic Company Report #JAUSA-31982 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Risperdal Initial or Prolonged Aggression Professional (Risperidone) PS Janssen ORAL 6 MG 1 DAILY Agitation ORAL Disorientation Medication Error Paranoia Date:02/25/99ISR Number: 3212637-6Report Type:Periodic Company Report #JAUSA-33671 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Risperdal (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Propranolol C Date:02/25/99ISR Number: 3212638-8Report Type:Periodic Company Report #JAUSA-31985 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Professional (Risperidone) PS Janssen ORAL (SEE IMAGE) DAILY ORAL 22-Feb-2006 08:20 AM Page: 456 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium C Date:02/25/99ISR Number: 3212639-XReport Type:Periodic Company Report #JAUSA-33672 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Risperdal (Risperidone), Janssen, Tablet 2 Mg PS ORAL 2 MG 1 DAILY ORAL Lithium C Prozac C Effexor C Ativan C Plendil C Premarin C Progesterone C Synthroid C Date:02/25/99ISR Number: 3212641-8Report Type:Periodic Company Report #JAUSA-31992 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Professional (Risperidone) PS Janssen ORAL .5 MG 1 DAILY ORAL Insulin C Date:02/25/99ISR Number: 3212642-XReport Type:Periodic Company Report #JAUSA-33674 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 3 MG 2 DAILY ORAL Effexor (Venlafexine) SS 6 MON Date:02/25/99ISR Number: 3212643-1Report Type:Periodic Company Report #JAUSA-33675 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL/ .5 MG 1 DAILY Depakota C Dexamethasone C 22-Feb-2006 08:20 AM Page: 457 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212644-3Report Type:Periodic Company Report #JAUSA-32004 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Fear Professional (Risperidone) PS Janssen ORAL (SEE IMAGE) Psychotic Disorder DAILY ORAL Date:02/25/99ISR Number: 3212646-7Report Type:Periodic Company Report #JAUSA-33676 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Health Risperdal Dysphagia Professional (Risperidone), Sedation Janssen, Tablet 1 Mg PS Janssen ORAL .5 MG 1 DAILY ORAL/1 MG 2 DAILY/2 MG 3 DAILY/1 MG 3 DAILY Depakote C Tegretol C Benztropine C Date:02/25/99ISR Number: 3212647-9Report Type:Periodic Company Report #JAUSA-32005 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Consumer Risperdal Weight Increased (Risperidone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3212650-9Report Type:Periodic Company Report #JAUSA-33677 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Consumer Risperdal Condition Aggravated (Risperidone), Constipation Janssen, Tablet 1 Mg PS Janssen ORAL 2 MG 1 DAILY Gait Disturbance ORAL Gingival Atrophy Depakote C Skin Disorder Cogentin C Thrombocytopenia Cardura C Urinary Incontinence Date:02/25/99ISR Number: 3212652-2Report Type:Periodic Company Report #JAUSA-33678 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Drooling Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG 1 DAILY ORAL/ 4 MG 1 DAILY/ 3 MG 1 DAILY 22-Feb-2006 08:20 AM Page: 458 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212656-XReport Type:Periodic Company Report #JAUSA-33681 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 5 MG 1 DAILY ORAL Olanzapine (Olanzapine) Capsules SS ORAL ORAL Date:02/25/99ISR Number: 3212660-1Report Type:Periodic Company Report #JAUSA-33682 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Consumer Risperdal Hypothyroidism (Risperidone), Laboratory Test Abnormal Janssen, Tablet 3 Mg PS Janssen ORAL 6 MG 1 DAILY ORAL Lithium C Date:02/25/99ISR Number: 3212662-5Report Type:Periodic Company Report #JAUSA-33687 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Risperdal Initial or Prolonged Drug Effect Increased Professional (Risperidone), Electrocardiogram Qt Janssen, Tablet PS Janssen ORAL 100 MG SINGLE Prolonged ORAL Extrapyramidal Disorder Alcohol (Alcohol) SS ORAL ORAL Hallucination Prozac C Orthostatic Hypotension Clozapine C Sedation Suicide Attempt Date:02/25/99ISR Number: 3212664-9Report Type:Periodic Company Report #JAUSA-33730 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Risperdal Eye Disorder Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Paxil C Cephalexin C Date:02/25/99ISR Number: 3212671-6Report Type:Periodic Company Report #JAUSA-33740 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Phlebitis Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL DAILY ORAL/ 1 TO 1.5 MG DAILY Wellbutrin (Amfebutamone) C 22-Feb-2006 08:20 AM Page: 459 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212679-0Report Type:Periodic Company Report #JAUSA-33741 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Risperdal Menorrhagia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG 2 DAILY ORAL/4 MG DAILY/ 3 MG DAILY Lodine C Date:02/25/99ISR Number: 3212686-8Report Type:Periodic Company Report #JAUSA-33744 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Risperdal Laboratory Test Abnormal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL , ORAL Coumadin (Warfarin) SS Date:02/25/99ISR Number: 3212692-3Report Type:Periodic Company Report #JAUSA-33967 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Risperdal Phosphokinase Increased Professional (Risperidone) PS Janssen ORAL 2MG 1 DAILY Condition Aggravated ORAL 3 YR Fatigue Muscular Weakness Date:02/25/99ISR Number: 3212696-0Report Type:Periodic Company Report #JAUSA-33753 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal Initial or Prolonged Hepatitis (Risperidone), Visual Disturbance Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG 2 DAILY ORAL; .5 MG ORAL Klonopin C Zoloft C Date:02/25/99ISR Number: 3212700-XReport Type:Periodic Company Report #JAUSA-33969 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal Tardive Dyskinesia Professional (Risperidone) PS Janssen ORAL ORAL Buspar (Buspirone) SS ORAL 15MG 2 DAILY ORAL Trazodone (Trazodone) SS ORAL 350MG 1 DAILY ORAL Paxil C 22-Feb-2006 08:20 AM Page: 460 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212708-4Report Type:Periodic Company Report #JAUSA-33973 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Eskalith C Date:02/25/99ISR Number: 3212714-XReport Type:Periodic Company Report #JAUSA-33974 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Risperdal Therapeutic Response (Risperidone) PS Janssen ORAL ORAL Decreased Date:02/25/99ISR Number: 3212720-5Report Type:Periodic Company Report #JAUSA-33975 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothermia Health Risperdal Professional (Risperidone) PS Janssen ORAL 1MG 2 DAILY ORAL Imodium C Buspar C Percocet C Compazine C Milk Of Magnesia C Desyrel C Mysoline C Date:02/25/99ISR Number: 3212727-8Report Type:Periodic Company Report #JAUSA-33986 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone) PS Janssen ORAL 1MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212733-3Report Type:Periodic Company Report #JAUSA-33988 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal (Risperidone) PS Janssen ORAL 2MG 1 DAILY ORAL Tegretol C Date:02/25/99ISR Number: 3212740-0Report Type:Periodic Company Report #JAUSA-33989 Age:31 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Professional (Risperidone) PS Janssen ORAL 1MG 2 DAILY ORAL 1 MON 22-Feb-2006 08:20 AM Page: 461 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212754-0Report Type:Periodic Company Report #JAUSA-33993 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Consumer Risperdal Initial or Prolonged (Risperidone) PS Janssen ORAL 1MG 2 DAILY ORAL ... C Cogentin C Percocet C Date:02/25/99ISR Number: 3212758-8Report Type:Periodic Company Report #JAUSA-34004 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Convulsion Professional (Risperidone) PS Janssen ORAL 2MG 2 DAILY Grand Mal Convulsion ORAL Depakote C Neurontin C Date:02/25/99ISR Number: 3212767-9Report Type:Periodic Company Report #JAUSA-34016 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Health Risperdal Professional (Risperidone) PS Janssen ORAL .5MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212773-4Report Type:Periodic Company Report #JAUSA-34018 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Erectile Dysfunction Professional (Risperidone) PS Janssen ORAL 1MG 2 DAILY ORAL, 2MG 2 DAILY ORAL,2MG 1 DAILY 62 DAY Risperdal (Risperidone) Solution SS Janssen ORAL 8MG 1 DAILY ORAL, 6 MG 1 DAILY Date:02/25/99ISR Number: 3212779-5Report Type:Periodic Company Report #JAUSA-34077 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Risperdal Initial or Prolonged Neuroleptic Malignant Professional (Risperidone) PS Janssen ORAL 1MG 1 DAILY Syndrome ORAL Haldol (Haloperidol) SS Janssen ORAL ORAL Prolixin (Fluphenazine) SS Prolixin-Deconate SS 7 DAY 22-Feb-2006 08:20 AM Page: 462 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212783-7Report Type:Periodic Company Report #JAUSA-34088 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone) PS Janssen ORAL 1.5MG 2 DAILY ORAL,3MG 2 DAILY ORAL Date:02/25/99ISR Number: 3212789-8Report Type:Periodic Company Report #JAUSA-34089 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 3MG DAILY Menstrual Disorder ORAL Visual Disturbance Loxitane C Date:02/25/99ISR Number: 3212796-5Report Type:Periodic Company Report #JAUSA-34090 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Consumer Risperdal Dystonia (Risperidone) PS Janssen ORAL 3MG 1 DAILY Malaise ORAL Date:02/25/99ISR Number: 3212847-8Report Type:Periodic Company Report #JAUSA-34091 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal Condition Aggravated (Risperidone) PS Janssen ORAL .5MG 3 DAILY Conjunctivitis ORAL Keratoconjunctivitis Librium C Sicca Valium C Pruritus Lodine C Therapeutic Response Tylenol C Unexpected Visual Disturbance Date:02/25/99ISR Number: 3212852-1Report Type:Periodic Company Report #JAUSA-34093 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal Professional (Risperidone) PS Janssen ORAL 1MG 2 DAILY ORAL Date:02/25/99ISR Number: 3212856-9Report Type:Periodic Company Report #JAUSA-34095 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal Decreased Professional (Risperidone) PS Janssen ORAL .5MG 2 DAILY ORAL, 1MG 2 DAILY, 3MG 2 DAILY,1.5MG 2 22-Feb-2006 08:20 AM Page: 463 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAILY, 2MG 2 63 DAY Neurontin C Date:02/25/99ISR Number: 3212865-XReport Type:Periodic Company Report #JAUSA-34097 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 3MG 2 DAILY ORAL Effexor C Date:02/25/99ISR Number: 3212961-7Report Type:Periodic Company Report #JAUSA-34182 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Professional (Risperidone) PS Janssen ORAL 6 MG / 9 MG ORAL Date:02/25/99ISR Number: 3212964-2Report Type:Periodic Company Report #JAUSA-34185 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Consumer Risperdal Alopecia (Risperidone), Anorexia Janssen, Tablet PS Janssen ORAL ORAL Conjunctivitis Ativan C Depersonalisation Restoril C Dermatitis Exfoliative Insomnia Libido Decreased Tooth Disorder Weight Decreased Date:02/25/99ISR Number: 3212967-8Report Type:Periodic Company Report #JAUSA-34202 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Risperdal Sedation (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL Vitamins And Mineral (Vitamins And Minerals) C Date:02/25/99ISR Number: 3212970-8Report Type:Periodic Company Report #JAUSA-34203 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Risperdal PS Janssen ORAL .5 MG 3 DAILY Initial or Prolonged Fall ORAL Gait Disturbance Xanax C Pneumonia Vitam. B12 C Temazepam C Prozac C 22-Feb-2006 08:20 AM Page: 464 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dapsone C Wellbutrin C Promethazine C Morphine Sr C Morphine Ir C Procrit C Date:02/25/99ISR Number: 3212972-1Report Type:Periodic Company Report #JAUSA-34228 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Risperdal Professional (Risperidone), Janssen Tablet PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3212975-7Report Type:Periodic Company Report #JAUSA-34229 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal White Blood Cell Count Professional (Risperidone), Decreased Janssen, Tablet PS Janssen ORAL ORAL Ritalin C Trazodone C Date:02/25/99ISR Number: 3212977-0Report Type:Periodic Company Report #JAUSA-34230 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 8 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3212979-4Report Type:Periodic Company Report #JAUSA-34233 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 4 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3212980-0Report Type:Periodic Company Report #JAUSA-34234 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG 2 DAILY ORAL/5 MG DAILY/3 MG 2 DAILY Lithium C 22-Feb-2006 08:20 AM Page: 465 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212982-4Report Type:Periodic Company Report #JAUSA-34235 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Pain Health Risperdal Galactorrhoea Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG 1 DAILY ORAL / .5 1 DAILY ORAL Date:02/25/99ISR Number: 3212984-8Report Type:Periodic Company Report #JAUSA-34241 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Consumer Risperdal Sedation (Risperidone), Janssen Tablet 3 Mg PS Janssen ORAL 3 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212985-XReport Type:Periodic Company Report #JAUSA-34244 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Insomnia (Risperidone), Sedation Janssen, Tablet 1 Mg PS Janssen ORAL 4 MG 1 DAILY ORAL / 3 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3212987-3Report Type:Periodic Company Report #JAUSA-34246 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Testicular Disorder Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3212990-3Report Type:Periodic Company Report #JAUSA-34247 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG DAILY ORAL Cogentin C Date:02/25/99ISR Number: 3212992-7Report Type:Periodic Company Report #JAUSA-34250 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG DAILY ORAL Cogentin C 22-Feb-2006 08:20 AM Page: 466 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3212995-2Report Type:Periodic Company Report #JAUSA-34253 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG 1 DAILY ORAL Wellbutrin C Date:02/25/99ISR Number: 3212996-4Report Type:Periodic Company Report #JAUSA-34254 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pruritus Consumer Risperdal Weight Increased (Risperidone) Janssen, Tablet PS Janssen ORAL ORAL Benadryl C Date:02/25/99ISR Number: 3212997-6Report Type:Periodic Company Report #JAUSA-34257 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thinking Abnormal Consumer Risperdal (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL 4 MG 2 DAILY ORAL Lithium C Vitamin B6 C Vitamins C Amadryl C Date:02/25/99ISR Number: 3212998-8Report Type:Periodic Company Report #JAUSA-34271 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG 4 DAILY ORAL/4 MG 2 DAILY ORAL/2 MG 2 DAILY ORAL 2 DAY Klonopin C Tegretal C Date:02/25/99ISR Number: 3212999-XReport Type:Periodic Company Report #JAUSA-34287 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Risperdal Initial or Prolonged Hypotension Professional (Risperidone), Hypothermia Janssen, Tablet 1 Mg PS Janssen ORAL 1.5 MG 2 DAILY ORAL Klonopin C Asa C Synthroid C 22-Feb-2006 08:20 AM Page: 467 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trazodone C Date:02/25/99ISR Number: 3213004-1Report Type:Periodic Company Report #JAUSA-33934 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Rispredal PS Janssen ORAL 1 MG 1 DAILY Fatigue ORAL; SEE Visual Disturbance IMAGE Xanax (Alprazolam) C Depakote (Valproate Sodium) C Date:02/25/99ISR Number: 3213005-3Report Type:Periodic Company Report #JAUSA-33935 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Decreased Professional ORAL; 2MG 1DAILY; 3 MG 2 DAILY;4 MG 2 DAILY 4 DAY Haldol (Haloperidol) C Date:02/25/99ISR Number: 3213006-5Report Type:Periodic Company Report #JAUSA-33937 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen ORAL ORAL Initial or Prolonged Date:02/25/99ISR Number: 3213007-7Report Type:Periodic Company Report #JAUSA-33938 Age:71 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Professional ORAL Multivitamins C Vitamin B Complex With C C Date:02/25/99ISR Number: 3213008-9Report Type:Periodic Company Report #JAUSA-33940 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal PS Janssen ORAL 1 MG 1 DAILY Decreased Professional ORAL Multivitamins C Thiamine C 22-Feb-2006 08:20 AM Page: 468 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213009-0Report Type:Periodic Company Report #JAUSA-33941 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhinitis Consumer Risperdal PS Janssen ORAL .5 MG 2 DAY Salivary Hypersecretion ORAL Aricept C Desyrel C Date:02/25/99ISR Number: 3213010-7Report Type:Periodic Company Report #JAUSA-33942 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Deposits Health Risperdal PS Janssen ORAL ORAL Professional Date:02/25/99ISR Number: 3213011-9Report Type:Periodic Company Report #JAUSA-33943 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperidal PS Jenssen ORAL 3 MG 2 DAILY Mania Professional ORAL Date:02/25/99ISR Number: 3213012-0Report Type:Periodic Company Report #JAUSA-33944 Age:83 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Risperdal PS Janssen ORAL 1 DAILY ORAL Gait Disturbance Lasix C Tremor Nitafuratin C Date:02/25/99ISR Number: 3213013-2Report Type:Periodic Company Report #JAUSA-33945 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Professional ORAL Haldol C Date:02/25/99ISR Number: 3213014-4Report Type:Periodic Company Report #JAUSA-33947 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Vomiting Consumer Risperdal PS Janssen ORAL 4 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3213015-6Report Type:Periodic Company Report #JAUSA-33948 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal PS Janssen ORAL 3 MG DAILY Arthralgia ORAL SEE Confusional State IMAGE; 1 MG 1 Dizziness DAILY Dyspnoea Depakote C 22-Feb-2006 08:20 AM Page: 469 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213016-8Report Type:Periodic Company Report #JAUSA-33949 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 2 MG 1 DAILY Diabetes Mellitus Professional ORAL; Diarrhoea ESTIMATED Thrombocytopenia DATES Glucophage (Metformin) SS ORAL ORAL; ESTIMATED DATES Senoquan C Date:02/25/99ISR Number: 3213017-XReport Type:Periodic Company Report #JAUSA-33951 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal PS Janssen ORAL 2 MG 3 DAILY Professional ORAL Date:02/25/99ISR Number: 3213018-1Report Type:Periodic Company Report #JAUSA-33953 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Consumer Risperdal PS Janssen ORAL .5 MG 1 DAILY ORAL Lanoxin C Glucotrol C Potassium C Ativan C Prozac C Vasotec C Allopurinol C Estratab C Sinement C Axid C Darvocet C Date:02/25/99ISR Number: 3213019-3Report Type:Periodic Company Report #JAUSA-33956 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Consumer Risperdal PS Janssen ORAL 9 MG DAILY ORAL Date:02/25/99ISR Number: 3213020-XReport Type:Periodic Company Report #JAUSA-33957 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Consumer Risperdal PS Janssen ORAL ORAL Unspecified Psychotropic Drugs SS 22-Feb-2006 08:20 AM Page: 470 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213021-1Report Type:Periodic Company Report #JAUSA-33959 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Consumer Risperdal PS Janssen ORAL 3 MG 2 DAILY Salivary Hypersecretion ORAL; 1.5 MG 2 DAILY ORAL Norvasc C Cogentin C Synthroid C Date:02/25/99ISR Number: 3213022-3Report Type:Periodic Company Report #JAUSA-33960 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Keratoconjunctivitis Consumer Risperdal PS Janssen ORAL ORAL 3 DAY Sicca Valium C Visual Disturbance Librium C Date:02/25/99ISR Number: 3213023-5Report Type:Periodic Company Report #JAUSA-33962 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Consumer Risperdal PS Janssen ORAL 4 MG 2 DAILY Tremor ORAL Lithium C Date:02/25/99ISR Number: 3213024-7Report Type:Periodic Company Report #JAUSA-34104 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diplopia Health Risperdal Professional (Risperidone), Janssen, Tablet PS ORAL .5 MG 1 DAILY Lipitor (Atorvastatin) C Clonidine (Clonidine) C Hypertension C Verapamil (Verapamil) C Date:02/25/99ISR Number: 3213025-9Report Type:Periodic Company Report #JAUSA-34111 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuropathy Peripheral Health Risperdal Professional (Risperidone), Janssen, Tablet PS ORAL 1 MG Multivitamins (R) C Date:02/25/99ISR Number: 3213026-0Report Type:Periodic Company Report #JAUSA-34113 Age:52 YR Gender:Female I/FU:I Outcome PT Hospitalization - Apnoea Initial or Prolonged Dystonia 22-Feb-2006 08:20 AM Page: 471 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal (Risperidone), Janssen, Tablet PS ORAL SINGLE ORAL; 3 & 1/2 YEARS AGO Date:02/25/99ISR Number: 3213027-2Report Type:Periodic Company Report #JAUSA-34118 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Pituitary Tumour Benign Professional (Risperidone), Janssen PS Date:02/25/99ISR Number: 3213028-4Report Type:Periodic Company Report #JAUSA-34126 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Risperdal Hypertrophy Breast (Risperidone), Janssen, Tablet PS ORAL Date:02/25/99ISR Number: 3213029-6Report Type:Periodic Company Report #JAUSA-34127 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Consumer Risperdal Diplopia (Risperidone), Dizziness Janssen, Tablet 1mg PS ORAL 1 MG 2 DAILY Photophobia Zoloft (Sertraline) C Date:02/25/99ISR Number: 3213030-2Report Type:Periodic Company Report #JAUSA-34132 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone), Janssen, Tablet 1mg PS ORAL 1 MG DAILY Depakote (Valproate Sodium) C Lithium (Lithium) C Date:02/25/99ISR Number: 3213072-7Report Type:Periodic Company Report #JAUSA-32234 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Risperdal Abnormal Professional (Risperidone) PS Janssen ORAL 11.5 MG DAILY ORAL Zoloft (Sertraline) C 22-Feb-2006 08:20 AM Page: 472 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213073-9Report Type:Periodic Company Report #JAUSA-32239 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Professional (Risperdone) PS Janssen ORAL 0.5 MG ORAL Date:02/25/99ISR Number: 3213075-2Report Type:Periodic Company Report #JAUSA-32240 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal Hyperprolactinaemia Professional (Risperdone) PS Janssen ORAL 6 MG DAILY ORAL Stelazine (Trifluoperazine) C Date:02/25/99ISR Number: 3213076-4Report Type:Periodic Company Report #JAUSA-32241 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Engorgement Health Risperdal Galactorrhoea Professional (Risperdone) PS Janssen ORAL 7 MG DAILY ORAL Neurontin (Gabapentin) C Prozac (Fluoxetine) C Date:02/25/99ISR Number: 3213078-8Report Type:Periodic Company Report #JAUSA-32244 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Orthostatic Hypotension Professional (Risperdone) PS Janssen ORAL .5 MG DAILY Sedation ORAL Aspirin (Acetylsalicylic-Aci d) C Timoptic (Tinolol) C Lorazepam (Lorazepam) C Date:02/25/99ISR Number: 3213080-6Report Type:Periodic Company Report #JAUSA-32245 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Headache Professional (Risperdone) PS Janssen ORAL 1 MG 2 DAILY Hyperprolactinaemia ORAL Oedema Lithium (Lithium) C Visual Disturbance Benztropine Weight Increased (Benztropine) C Ortho-Novum (Ortho-Novum(R)) C Hyperprolactinaemia C 22-Feb-2006 08:20 AM Page: 473 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213082-XReport Type:Periodic Company Report #JAUSA-32247 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal Deficit/Hyperactivity Professional (Risperdone) PS Janssen ORAL 3 MG 2 DAILY Disorder ORAL Galactorrhoea Cogentin (Benztropine) C Motrin (Ibuprofen) C Date:02/25/99ISR Number: 3213084-3Report Type:Periodic Company Report #JAUSA-32308 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Risperdal Initial or Prolonged Hypothermia Professional (Risperdone) PS Janssen ORAL 1 MG 2 DAILY Laboratory Test Abnormal ORAL Pneumonia Zyprexa (Olanzapine) C Neurontin (Gabapentin) C Ativan (Lorazepam) C Synthroid (Levothyroxine) C Date:02/25/99ISR Number: 3213086-7Report Type:Periodic Company Report #JAUSA-32310 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Risperdal Initial or Prolonged Professional (Risperdone) PS Janssen ORAL 1 MG 2 DAILY ORAL 6 WK Date:02/25/99ISR Number: 3213087-9Report Type:Periodic Company Report #JAUSA-32316 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Photosensitivity Reaction Health Risperdal Professional (Risperdone) PS ORAL 3 MG 2 DAILY ORAL Trazodone (Trazodone) C Date:02/25/99ISR Number: 3213089-2Report Type:Periodic Company Report #JAUSA-32325 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperdone) PS Janssen ORAL 1 MG 2 DAILY ORAL Zoloft (Sertraline) C Norvasc (Amlodipine) C Capoten (Captopril) C Benadryl (Diphenhydramine) C Glucotrol (Glipizide) C Maxzide (Maxzide 22-Feb-2006 08:20 AM Page: 474 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (R)) C Folic Acid (Folic Acid) C Multivit (Multivit (R)) C Date:02/25/99ISR Number: 3213090-9Report Type:Periodic Company Report #JAUSA-32327 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperdone) PS Janssen ORAL 3 MG DAILY ORAL Date:02/25/99ISR Number: 3213091-0Report Type:Periodic Company Report #JAUSA-32342 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urine Abnormality Health Risperdal Professional (Risperdone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3213093-4Report Type:Periodic Company Report #JAUSA-32384 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Salivary Hypersecretion Study Risperdal Initial or Prolonged Sedation Health (Risperdone) PS Janssen ORAL 6 MG DAILY Speech Disorder Professional ORAL Clozapine (Clozapine) SS ORAL -- , DAILY, ORAL Depakote (Valproate Sodium) C Trazodone (Trazodone) C Date:02/25/99ISR Number: 3213094-6Report Type:Periodic Company Report #JAUSA-32385 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urine Abnormality Health Risperdal Professional (Risperdone) PS Janssen ORAL 2 MG 1 DAILY ORAL Lithium (Lithium) C Date:02/25/99ISR Number: 3213096-XReport Type:Periodic Company Report #JAUSA-32388 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Health Risperdal Involuntary Professional (Risperdone) PS Janssen ORAL --, ORAL Prozac (Fluoxetine) C Akineton (Biperiden) C 22-Feb-2006 08:20 AM Page: 475 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213097-1Report Type:Periodic Company Report #JAUSA-32391 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Risperdal Urinary Incontinence Professional (Risperdone) PS Janssen ORAL 6 MG 1 DAILY Weight Increased ORAL Prozac (Fluoxetine) C Artane (Trihexyphenidryl) C Date:02/25/99ISR Number: 3213099-5Report Type:Periodic Company Report #JAUSA-32393 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urticaria Health Risperdal Professional (Risperdone) PS Janssen ORAL 5 MG 2 DAILY ORAL Clonidine (Clonidine) C Date:02/25/99ISR Number: 3213102-2Report Type:Periodic Company Report #JAUSA-32394 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Professional (Risperdone) PS Janssen ORAL 1 MG 2 DAILY ORAL Dilantin (Phenytoin) C Date:02/25/99ISR Number: 3213103-4Report Type:Periodic Company Report #JAUSA-32398 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Conjunctival Haemorrhage Health Risperdal Electrocardiogram Professional (Risperdone) PS Janssen ORAL 0.5 MG DAILY Abnormal ORAL 2 DAY Orthostatic Hypotension Prozac (Fluoxetine) C Syncope Aricept (Donepezil) C Premarin (Estrogens Conjugated) C Date:02/25/99ISR Number: 3213106-XReport Type:Periodic Company Report #JAUSA-32399 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Neutropenia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG DAILY ORAL Cogentin C 22-Feb-2006 08:20 AM Page: 476 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213108-3Report Type:Periodic Company Report #JAUSA-32400 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Health Risperdal Orthostatic Hypotension Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG DAILY ORAL Date:02/25/99ISR Number: 3213109-5Report Type:Periodic Company Report #JAUSA-32401 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Health Risperdal Initial or Prolonged Deficit/Hyperactivity Professional (Risperidone), Disorder Janssen, Tablet PS Janssen ORAL 2 MG DAILY Condition Aggravated ORAL Muscle Contractions Depakote C Involuntary Date:02/25/99ISR Number: 3213110-1Report Type:Periodic Company Report #JAUSA-32405 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Risperdal Confusional State Professional (Risperidone), Gait Disturbance Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG DAILY Speech Disorder ORAL .25MG IN AM .75MG IN PM ESTIMATED DATE Date:02/25/99ISR Number: 3213112-5Report Type:Periodic Company Report #JAUSA-32408 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neurosis Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL DAILY, ORAL TREATMENT WAS LESS THEN 4 MG DAILY. Cogentin C Date:02/25/99ISR Number: 3213116-2Report Type:Periodic Company Report #JAUSA-32410 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Lithium C 22-Feb-2006 08:20 AM Page: 477 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213117-4Report Type:Periodic Company Report #JAUSA-32411 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG 2 DAILY ORAL Wellbutrin C Tegretol C Date:02/25/99ISR Number: 3213118-6Report Type:Periodic Company Report #JAUSA-33868 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Risperdal Condition Aggravated Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3213120-4Report Type:Periodic Company Report #JAUSA-32412 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Consumer Risperdal Involuntary (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG 1 DAILY ORAL Ritalin Sr C Date:02/25/99ISR Number: 3213121-6Report Type:Periodic Company Report #JAUSA-33874 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Faecal Incontinence (Risperidone), Migraine Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 1 DAILY Vomiting ORAL; ESTIMATED START DATE Depakote (Valproate Sodium) C Ativan (Lorazepam) C Date:02/25/99ISR Number: 3213123-XReport Type:Periodic Company Report #JAUSA-33876 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Muscle Contractions Professional (Risperidone), Involuntary Janssen, Tablet PS Janssen ORAL 8 MG DAILY ORAL; HAS BEEN TAKING IT FOR MORE THAN TWO 22-Feb-2006 08:20 AM Page: 478 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213125-3Report Type:Periodic Company Report #JAUSA-33878 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Consumer Risperdal Initial or Prolonged (Risperidone), Janssen, Tablet PS Janssen ORAL DAILY ORAL; DOSE RANGED FROM 7.5 - 9 MG Olanzapine (Olanzapine) C Prozac (Fluoxetine) C Date:02/25/99ISR Number: 3213126-5Report Type:Periodic Company Report #JAUSA-32413 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Risperdal Syncope Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG 2 DAILY ORAL Zoloft C Date:02/25/99ISR Number: 3213128-9Report Type:Periodic Company Report #JAUSA-33885 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Risperdal Initial or Prolonged Cyanosis Professional (Risperidone), Tremor Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 2 DAILY Urinary Incontinence ORAL Levodopa (Levodopa) C Date:02/25/99ISR Number: 3213129-0Report Type:Periodic Company Report #JAUSA-32414 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Consumer Risperdal Abdominal Pain (Risperidone), Diarrhoea Janssen, Tablet 3 Mg PS Janssen ORAL SEE IMAGE Hepatic Function Abnormal Depakote C Pituitary Tumour Zoloft C Weight Decreased Cogentin C Date:02/25/99ISR Number: 3213130-7Report Type:Periodic Company Report #JAUSA-33894 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Consumer Risperdal Insomnia (Risperidone), Thinking Abnormal Janssen, Tablet 3 Mg PS Janssen ORAL 6 MG 1 DAILY Urine Abnormality ORAL; 2 MG 1 DAILY ORAL TABLET 2 MG Depakote (Valproate Sodium) C 22-Feb-2006 08:20 AM Page: 479 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213132-0Report Type:Periodic Company Report #JAUSA-32415 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Risperdal Apathy Professional (Risperidone), Disturbance In Attention Janssen, Tablet PS Janssen ORAL ORAL Suicide Attempt Diazepam (Diazepam) SS 10 MG DAILY 15 YR Date:02/25/99ISR Number: 3213133-2Report Type:Periodic Company Report #JAUSA-33896 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Keratoconjunctivitis (Risperidone), Sicca Janssen, Tablet 1 Mg PS Janssen ORAL 1.5 MG 2 DAILY ORAL Valium (Diazepam) C Librium (Chlordiazepoxide) C Date:02/25/99ISR Number: 3213134-4Report Type:Periodic Company Report #JAUSA-32416 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 5 MG DAILY ORAL 2 MG IN THE MORNING, 3 MG AT BEDTIME. Ritalin C Date:02/25/99ISR Number: 3213136-8Report Type:Periodic Company Report #JAUSA-33901 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Anxiety (Risperidone), Dizziness Janssen, Tablet PS Janssen ORAL 2 MG 1 DAILY Emotional Disorder ORAL Extrapyramidal Disorder Ativan C Insomnia Periactin Nervousness (Cyproheptadine) C Oedema Tenormin (Atenolol) C Nsaid Unspec (Nsaid Unspec) C Acetaminophen (Paracetamol) C Date:02/25/99ISR Number: 3213137-XReport Type:Periodic Company Report #JAUSA-32418 Age:30 YR Gender:Female I/FU:I Outcome PT Other Agitation Condition Aggravated Muscle Contractions 22-Feb-2006 08:20 AM Page: 480 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Involuntary Sedation Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL 6 MG DAILY ORAL 4 MG 2 DAILY Date:02/25/99ISR Number: 3213138-1Report Type:Periodic Company Report #JAUSA-33907 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal Deficit/Hyperactivity Professional (Risperidone), Disorder Janssen, Tablet PS Janssen ORAL ORAL Respiratory Disorder Unspecified (Unspecified) C Date:02/25/99ISR Number: 3213139-3Report Type:Periodic Company Report #JAUSA-32419 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL SEE IMAGE 9 MON Date:02/25/99ISR Number: 3213140-XReport Type:Periodic Company Report #JAUSA-33910 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Health Risperdal Keratoconjunctivitis Professional (Risperidone), Sicca Janssen,Tablet 1 Mg PS Janssen ORAL 1 MG DAILY ORAL;ESTIMATE D START DATE; 12 MG ORAL TABLET Lithium (Lithium) C Benadryl (Diphenhydramine) C Date:02/25/99ISR Number: 3213141-1Report Type:Periodic Company Report #JAUSA-33380 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Drug Withdrawal Syndrome Professional (Risperidone), Disability Dyskinesia Janssen, Tablet PS Janssen ORAL DAILY, ORAL 6 TO 9 MG 2 TO 3 TIMES DAILY. Haloperidol C Hydroxyzine C Diphenhydramine C Tofranil C Mellaril C 22-Feb-2006 08:20 AM Page: 481 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ritalin C Clomipramine C Vistaril C Buspar C Clonidine C Date:02/25/99ISR Number: 3213142-3Report Type:Periodic Company Report #JAUSA-33397 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Upper Respiratory Tract Professional (Risperidone), Infection Janssen, Tablet PS Janssen ORAL ORAL Erythromycin C Date:02/25/99ISR Number: 3213143-5Report Type:Periodic Company Report #JAUSA-33912 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Disorder Health Risperdal Sedation Professional (Risperidone),Jansse n, Tablet PS Janssen ORAL 1 MG 2 DAILY ORAL Clonidine (Clonidine) C Norvasc (Amlodipine) C Zoloft (Sertraline) C Date:02/25/99ISR Number: 3213144-7Report Type:Periodic Company Report #JAUSA-32008 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypokalaemia Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, ORAL Date:02/25/99ISR Number: 3213145-9Report Type:Periodic Company Report #JAUSA-33425 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Risperdal Phosphokinase Increased Professional (Risperidone), Electrocardiogram Qt Janssen, Tablet PS Janssen ORAL DAILY, ORAL Corrected Interval Thioridazine Prolonged (Thioridazine) SS ORAL 100 MG DAILY Hepatic Function Abnormal ORAL Amantadine C Buspar C Motrin C Date:02/25/99ISR Number: 3213146-0Report Type:Periodic Company Report #JAUSA-33920 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sleep Walking Health Risperdal Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 2 DAILY 22-Feb-2006 08:20 AM Page: 482 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL; 2 MG, 3 MG 2 DAILY; 3 MG 1 DAILY ORAL TABLET 14 DAY Ativan C Paxil C Lithium C Trilafon (Perphenazine) C Ambien (Zolpidem) C Date:02/25/99ISR Number: 3213147-2Report Type:Periodic Company Report #JAUSA-32010 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Professional (Risperidone) PS Janssen ORAL 6 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3213148-4Report Type:Periodic Company Report #JAUSA-33437 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL .5 MG 2 DAILY ORAL Tegretol C Depakote C Ritalin C Date:02/25/99ISR Number: 3213149-6Report Type:Periodic Company Report #JAUSA-33921 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 3 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3213150-2Report Type:Periodic Company Report #JAUSA-33441 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1.5 MG DAILY ORAL 1 MG IN AM AND 0.5 MG AT BEDTIME Clonidine (Clonidine) SS 22-Feb-2006 08:20 AM Page: 483 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213151-4Report Type:Periodic Company Report #JAUSA-32014 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Idiopathic Health Risperdal Thrombocytopenic Purpura Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL Indocin (Indomethacin) SS ORAL ORAL Vitamins C Ultram C Date:02/25/99ISR Number: 3213152-6Report Type:Periodic Company Report #JAUSA-33926 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinsonism Health Risperdal Professional (Risperidone), Janssen PS Janssen ORAL .5 MG DAILY ORAL Clozaril (Clozapine) SS ORAL ORAL Sinemet (Sinemet(R)) C Date:02/25/99ISR Number: 3213153-8Report Type:Periodic Company Report #JAUSA-33444 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG DAILY ORAL 5 MG IN AM, 1 MG ADMINISTERED AT Date:02/25/99ISR Number: 3213154-XReport Type:Periodic Company Report #JAUSA-33927 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal Decreased Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 4 MG 1 DAILY; 5 MG 1 DAILY; ORAL GIVEN AT BEDTIME Date:02/25/99ISR Number: 3213155-1Report Type:Periodic Company Report #JAUSA-32018 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone) PS Janssen ORAL SEE IMAGE 22-Feb-2006 08:20 AM Page: 484 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213156-3Report Type:Periodic Company Report #JAUSA-33929 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Consumer Risperdal Involuntary (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL .25 MG 1 DAILY ORAL Adderall (Adderall(R)) C Claritine (Loratadine) C Date:02/25/99ISR Number: 3213157-5Report Type:Periodic Company Report #JAUSA-32019 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone) PS Janssen ORAL SEE IMAGE Date:02/25/99ISR Number: 3213158-7Report Type:Periodic Company Report #JAUSA-33930 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone), Pituitary Tumour Janssen, Tablet PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3213159-9Report Type:Periodic Company Report #JAUSA-32908 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS Janssen ORAL Hyperprolactinaemia Professional Date:02/25/99ISR Number: 3213160-5Report Type:Periodic Company Report #JAUSA-33931 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3213161-7Report Type:Periodic Company Report #JAUSA-32909 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal PS ORAL 3 MG 2 DAILY Thrombocytopenia Professional Date:02/25/99ISR Number: 3213162-9Report Type:Periodic Company Report #JAUSA-33932 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal Professional (Risperidone), 22-Feb-2006 08:20 AM Page: 485 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Janssen, Tablet PS Janssen ORAL ORAL; ESTIMATED START DATE Date:02/25/99ISR Number: 3213163-0Report Type:Periodic Company Report #JAUSA-33933 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone),Jansse n, Tablet 1 Mg PS Janssen ORAL 1 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3213164-2Report Type:Periodic Company Report #JAUSA-32911 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Health Risperdal PS ORAL 2-5 MG DAILY Dyskinesia Professional Effexor C Date:02/25/99ISR Number: 3213165-4Report Type:Periodic Company Report #JAUSA-32196 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Psychotic Disorder Professional (Risperidone) Tablet PS Janssen ORAL 2 MG DAILY ORAL Paxil (Paroxetine) C Cogentin (Benztropine) C Date:02/25/99ISR Number: 3213166-6Report Type:Periodic Company Report #JAUSA-32197 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Dialysis Professional (Risperidone) PS Janssen ORAL 4 MG DAILY Psychotic Disorder ORAL Zoloft (Sertraline) C Phoslo (Calcium Acetate) C Synthroid (Levothyroxine) C Nephrocaps (Nephrocaps R) C Ferrous Sulfate (Ferrous Sulfate) C Colace (Docusate Sodium) C Date:02/25/99ISR Number: 3213167-8Report Type:Periodic Company Report #JAUSA-32912 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Consumer Risperdal PS ORAL PRN Zyprexa (Olanzapine) SS 22-Feb-2006 08:20 AM Page: 486 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213168-XReport Type:Periodic Company Report #JAUSA-32198 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Consumer Risperdal White Blood Cell Disorder (Resperidone) PS Janssen ORAL .5 MG 2 DALY ORAL Zoloft (Sertraline) C Ativan (Loraxepam) C Lasix (Furosemide) C Date:02/25/99ISR Number: 3213169-1Report Type:Periodic Company Report #JAUSA-32914 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal PS ORAL .5 MG 1 DAILY Professional Date:02/25/99ISR Number: 3213170-8Report Type:Periodic Company Report #JAUSA-33758 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Consumer Risperdal Hypertrophy Breast (Risperidone), Increased Appetite Janssen, Tablet PS Janssen ORAL 3 MG DAILY Menstrual Disorder ORAL / 2 MG DAILY 21 WK Date:02/25/99ISR Number: 3213171-XReport Type:Periodic Company Report #JAUSA-32200 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Consumer Risperdal (Risperidone) PS Janssen ORAL ORAL TABLET Ativan (Lorazepam) C Cogentin (Benztropine) C Date:02/25/99ISR Number: 3213172-1Report Type:Periodic Company Report #JAUSA-32915 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone) PS ORAL 1 MG 2 DAILY Lasix (Furosemide) C Insulin (Insulin, Unspec) C Fosamax (Alendronate) C Date:02/25/99ISR Number: 3213173-3Report Type:Periodic Company Report #JAUSA-32201 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Libido Decreased Consumer Risperdal (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL 22-Feb-2006 08:20 AM Page: 487 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Wellbutrin (Amfebutamone) C Date:02/25/99ISR Number: 3213174-5Report Type:Periodic Company Report #JAUSA-33761 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematuria Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 4 MG 2 DAILY ORAL / 3 MG 2 DAILY Paxil (Paroxetine) C Date:02/25/99ISR Number: 3213175-7Report Type:Periodic Company Report #JAUSA-32917 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS Janssen ORAL 6 MG DAILY Galactorrhoea Zoloft (Sertraline) C Hyperhidrosis Hypertrophy Breast Paraesthesia Tremor Date:02/25/99ISR Number: 3213176-9Report Type:Periodic Company Report #JAUSA-32205 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Abnormal Health Risperdal White Blood Cell Count Professional (Risperidone) PS Janssen ORAL 3 MG DAILY Decreased ORAL Date:02/25/99ISR Number: 3213177-0Report Type:Periodic Company Report #JAUSA-33764 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Consumer Risperdal Pruritus (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 1 DAILY ORAL 4 MON Date:02/25/99ISR Number: 3213179-4Report Type:Periodic Company Report #JAUSA-32206 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Dermatitis Bullous Professional (Risperidone) PS Janssen ORAL 1 MG DAILY Flushing ORAL Prozac (Fluoxetine) C Prilosec (Omeprazole) C 22-Feb-2006 08:20 AM Page: 488 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213180-0Report Type:Periodic Company Report #JAUSA-33766 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal Insomnia (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG A DAILY ORAL Lithium (Lithium) C Serzone (Nefazodone) C Date:02/25/99ISR Number: 3213181-2Report Type:Periodic Company Report #JAUSA-32921 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Professional Ativan C Date:02/25/99ISR Number: 3213182-4Report Type:Periodic Company Report #JAUSA-32209 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acne Health Risperdal Condition Aggravated Professional (Risperidone) PS Janssen ORAL DAILY ORAL Zantac (Ranitidine) C Prozac (Fluoxetine) C Differin C Doxycycline C Klaron C Date:02/25/99ISR Number: 3213183-6Report Type:Periodic Company Report #JAUSA-32922 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Consumer Risperdal PS Janssen ORAL .5 MG 2 DAILY Nephrolithiasis Megace (Megestrol) C Urinary Incontinence Lasix Urinary Retention Urinary Tract Infection (Furosemide) C Hydrochlorothiazide C Benemid C Date:02/25/99ISR Number: 3213184-8Report Type:Periodic Company Report #JAUSA-33770 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone), Pituitary Tumour Benign Janssen, Tablet PS Janssen ORAL 2 MG 2 DAILY ORAL / 3 MG 1 DAILY 22-Feb-2006 08:20 AM Page: 489 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213185-XReport Type:Periodic Company Report #JAUSA-32215 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone) PS Janssen ORAL 5 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3213186-1Report Type:Periodic Company Report #JAUSA-32923 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Risperdal PS Janssen ORAL 3 MG 1 DAILY Nortriptyline (Nortriptyline) C Prozac (Fluoxetine) C Ativan (Lorazepam) C Date:02/25/99ISR Number: 3213187-3Report Type:Periodic Company Report #JAUSA-32020 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone) PS Janssen ORAL SEE IMAGE Date:02/25/99ISR Number: 3213188-5Report Type:Periodic Company Report #JAUSA-33803 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG 2 DAILY ORAL / 1.5 MG 1 DAILY 16 DAY Date:02/25/99ISR Number: 3213189-7Report Type:Periodic Company Report #JAUSA-32924 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal PS Janssen ORAL 1.5 MG 1 Depression DAILY Galactorrhoea Ativan (Lorazepam) C Hyperprolactinaemia Libido Decreased Date:02/25/99ISR Number: 3213190-3Report Type:Periodic Company Report #JAUSA-32217 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Increased Appetite Consumer Risperdal Weight Increased (Risperidone) PS Janssen ORAL .5 MG DAILY ORAL Depakote (Valproate Sodium) C 22-Feb-2006 08:20 AM Page: 490 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213191-5Report Type:Periodic Company Report #JAUSA-33808 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL -, ORAL Date:02/25/99ISR Number: 3213192-7Report Type:Periodic Company Report #JAUSA-32925 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Risperdal PS Janssen ORAL 1 MG 1 DAILY Depression Zoloft (Sertraline) C Headache Date:02/25/99ISR Number: 3213193-9Report Type:Periodic Company Report #JAUSA-32218 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cystitis Health Risperdal Professional (Risperidone) PS ORAL 3 MG DAILY ORAL Zyprexa (Olanzapine) C Mellaril (Thioridazone) C Luvox (Fluvoxamine) C Catapres (Clonidine) C Date:02/25/99ISR Number: 3213194-0Report Type:Periodic Company Report #JAUSA-32021 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone) PS Janssen ORAL UP TO 6MG DAILY Date:02/25/99ISR Number: 3213195-2Report Type:Periodic Company Report #JAUSA-33810 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL -, ORAL Insulin (Insulin, Unspec) C Date:02/25/99ISR Number: 3213196-4Report Type:Periodic Company Report #JAUSA-32219 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL Pamelor (Nortriptyline) C Diflucan 22-Feb-2006 08:20 AM Page: 491 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Fluconazole) C Date:02/25/99ISR Number: 3213197-6Report Type:Periodic Company Report #JAUSA-32926 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL Professional Date:02/25/99ISR Number: 3213198-8Report Type:Periodic Company Report #JAUSA-33822 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Engorgement Consumer Risperdal Condition Aggravated (Risperidone), Dyspnoea Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 2 DAILY Menstrual Disorder ORAL Myalgia Navane (Tiotixene) C Paranoia Lithium (Lithium) C Suicide Attempt Asacol (Mesalazine) C Weight Increased Date:02/25/99ISR Number: 3213199-XReport Type:Periodic Company Report #JAUSA-32022 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone) PS Janssen ORAL UP TO 6MG DAILY Date:02/25/99ISR Number: 3213200-3Report Type:Periodic Company Report #JAUSA-32927 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL 2 MG DAILY Professional Tegretol C Date:02/25/99ISR Number: 3213201-5Report Type:Periodic Company Report #JAUSA-32224 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone) PS Janssen ORAL .5 MG 2 DAILY ORAL Depakote (Valproate Sodium) SS ORAL 1000 MG DAILY ORAL Eskalith (Lithium) C Adderall C Date:02/25/99ISR Number: 3213202-7Report Type:Periodic Company Report #JAUSA-33823 Age:31 YR Gender:Male I/FU:I Outcome PT Other Agitation Hallucination, Auditory 22-Feb-2006 08:20 AM Page: 492 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paranoia Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG DAILY ORAL Prilosec C Klonopin (Clonazepam) C Nortriptyline (Nortriptyline) C Date:02/25/99ISR Number: 3213203-9Report Type:Periodic Company Report #JAUSA-32929 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL Professional Date:02/25/99ISR Number: 3213204-0Report Type:Periodic Company Report #JAUSA-32024 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone) PS Janssen ORAL UP TO 6MG DAILY Date:02/25/99ISR Number: 3213205-2Report Type:Periodic Company Report #JAUSA-32226 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Health Risperdal Professional (Risperidone) PS Janssen ORAL 2 MG 2 DALY ORAL Effexor (Venlafaxine) SS ORAL Depakote (Valproate Sodium) C Date:02/25/99ISR Number: 3213206-4Report Type:Periodic Company Report #JAUSA-33824 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 2 MG 2 DAILY ORAL Tegretol (Carbamezepine) C Norvasc (Amlodipine) C 22-Feb-2006 08:20 AM Page: 493 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213207-6Report Type:Periodic Company Report #JAUSA-32930 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal PS Jandden ORAL 1 MG DAILY Professional Date:02/25/99ISR Number: 3213208-8Report Type:Periodic Company Report #JAUSA-32227 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Health Risperdal Involuntary Professional (Risperidone) PS Janssen ORAL 9 MG 1 DAILY Tardive Dyskinesia ORAL Date:02/25/99ISR Number: 3213209-XReport Type:Periodic Company Report #JAUSA-33825 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL -, ORAL Aricept C Paxil (Paroxetine) C Digoxin C Lasix (Furosemide) C Diltiazem (Diltiazem) C Ambien (Zolpidem) C Date:02/25/99ISR Number: 3213210-6Report Type:Periodic Company Report #JAUSA-32932 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Macrocytic Health Risperdal PS Janssen ORAL Professional Tegretol C Date:02/25/99ISR Number: 3213211-8Report Type:Periodic Company Report #JAUSA-32025 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone) PS Janssen ORAL UP TO 6MG DAILY Date:02/25/99ISR Number: 3213212-XReport Type:Periodic Company Report #JAUSA-32228 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Health Risperdal Professional (Risperidone) PS Janssen ORAL 3 MG DAILY ORAL 22-Feb-2006 08:20 AM Page: 494 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213213-1Report Type:Periodic Company Report #JAUSA-32936 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Risperdal PS Janssen ORAL 3 MG 1 DAILY Paraesthesia Lipitor C Urinary Retention Cogentin C Klonopin C Deseril C Paxil C Date:02/25/99ISR Number: 3213214-3Report Type:Periodic Company Report #JAUSA-33831 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Risperdal Initial or Prolonged Professional (Risperidone),Jansse n, Tablet PS ORAL 3 MG 2 DAILY ORAL Eskalith C Glucotrol C Date:02/25/99ISR Number: 3213215-5Report Type:Periodic Company Report #JAUSA-32229 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 6 MG 1 DAILY Laboratory Test Abnormal ORAL Haloperidol C Trazodone C Amantadine C Clonazepam C Date:02/25/99ISR Number: 3213216-7Report Type:Periodic Company Report #JAUSA-32939 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen ORAL 5 MG 1 DAILY Initial or Prolonged Date:02/25/99ISR Number: 3213217-9Report Type:Periodic Company Report #JAUSA-33834 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Risperdal Hospitalization - Coma Professional (Risperidone), Initial or Prolonged Drug Effect Increased Janssen, Tablet 1 Mg PS Janssen ORAL SEE IMAGE Dyspnoea Xanax (Alprazolam) SS ORAL -, SINGLE Hypertension ORAL / .25 MG Hypothermia PRN Malaise Propulsid Pneumonitis (Cisapride) C Pneumothorax Anafranil Suicide Attempt (Clomipramine) C Paxil (Paroxetine) C Norvasc (Amlodipine) C Prilosec 22-Feb-2006 08:20 AM Page: 495 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Omeprazole) C Restoril (Temazepam C Prempro (Prempro (R)) C Poly-Histine-D (Poly-Histine-D (R)) C Tranxene (Clorazepate) C Premarin (Estrogens Conjugated) C Medroxyprogesterone (Medroxyprogesterone ) C Midrin (Midrin (R)) C Dicyclomine (Dicycloverine) C Date:02/25/99ISR Number: 3213218-0Report Type:Periodic Company Report #JAUSA-32027 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Risperdal Eye Pain Professional (Risperidone) PS Janssen ORAL SEE IMAGE Hypertonia Wellbutrin C Optic Neuritis Depakote C Date:02/25/99ISR Number: 3213219-2Report Type:Periodic Company Report #JAUSA-32230 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphadenopathy Health Risperdal Professional (Risperidone) PS Janssen ORAL 1.5 MG 1 DAILY ORAL Zyprexa (Olanzapine) Suspension SS ORAL 2.5 MG 1 DAILY ORAL Propulsid C Humulin 70/30 C Synthroid C Ferrous Sulfate C Hytrin C Zocor C Erythropoietin C Calcitrol C Losartan C Phoslo C Darvon C Atenolol C Nephro-Vite C Lactulose C Date:02/25/99ISR Number: 3213220-9Report Type:Periodic Company Report #JAUSA-32421 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Penis Disorder Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Professional ORAL; 1 MG 2 DAILY ORAL 11 DAY Albuterol C 22-Feb-2006 08:20 AM Page: 496 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213221-0Report Type:Periodic Company Report #JAUSA-33836 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG DAILY ORAL Depakote (Valproate Sodium) C Dexamethasone (Dexamethasone) C Ortho (Ortho (R)) C Date:02/25/99ISR Number: 3213222-2Report Type:Periodic Company Report #JAUSA-32036 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, ORAL Date:02/25/99ISR Number: 3213223-4Report Type:Periodic Company Report #JAUSA-32231 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertrophy Breast Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL Prozac C Cogentin C Date:02/25/99ISR Number: 3213224-6Report Type:Periodic Company Report #JAUSA-32424 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal PS ORAL ORAL Professional Paxil C Date:02/25/99ISR Number: 3213225-8Report Type:Periodic Company Report #JAUSA-33837 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depersonalisation Consumer Risperdal Depression (Risperidone), Increased Appetite Janssen, Tablet 1 Mg PS Janssen ORAL SEE IMAGE Insomnia Depakote (Valproate Weight Increased Sodium) C Prozac (Fluoxetine) C Lorazepam (Lorazepam) C Synthroid (Levothyroxine) C Tagamet (Cimetidine) C Calcium Lactate (Calcium Lactate) C 22-Feb-2006 08:20 AM Page: 497 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213226-XReport Type:Periodic Company Report #JAUSA-32428 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Miosis Health Risperdal PS Janssen ORAL 1 MG 2 DAILY Neuroleptic Malignant Professional ORAL Syndrome Levofloxacin C Pepcid C Atrovent C Flovent C Humibid C Ceclor C Clonidine C Vitamins, Unspec C Date:02/25/99ISR Number: 3213227-1Report Type:Periodic Company Report #JAUSA-32462 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Initial or Prolonged Anaemia Professional ORAL; 1.5 MG Condition Aggravated DAILY Convulsion ORAL;1.5 MG 2 Fatigue DAILY ORAL 5 WK Leukopenia Date:02/25/99ISR Number: 3213228-3Report Type:Periodic Company Report #JAUSA-33838 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Health Risperdal Initial or Prolonged Diabetes Mellitus Professional (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3213230-1Report Type:Periodic Company Report #JAUSA-32465 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen ORAL .5 MG 1 DAILY Initial or Prolonged Insomnia ORAL 2 DOSES Mania Lanoxin C Speech Disorder Aspirin C Centrum C Date:02/25/99ISR Number: 3213231-3Report Type:Periodic Company Report #JAUSA-33839 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL -, ORAL 22-Feb-2006 08:20 AM Page: 498 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213232-5Report Type:Periodic Company Report #JAUSA-32060 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Libido Decreased Professional (Risperidone) PS Janssen ORAL TABLET, ORAL Weight Increased Date:02/25/99ISR Number: 3213234-9Report Type:Periodic Company Report #JAUSA-32469 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Risperdal PS ORAL 3 MG 1DAILY Anorexia Professional ORAL; 2 MG 1 Condition Aggravated DAILY ORAL Dehydration Senokot C Insomnia Vitaplex Mineral C Weight Decreased Prevacid C Fibercon C Acidophilus C Date:02/25/99ISR Number: 3213236-2Report Type:Periodic Company Report #JAUSA-33844 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal Nausea (Risperidone), Janssen, Tablet PS Janssen ORAL -, ORAL Unspecified (Unspedified) C Date:02/25/99ISR Number: 3213240-4Report Type:Periodic Company Report #JAUSA-33859 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myocardial Infarction Health Risperdal Thinking Abnormal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL SEE IMAGE 30 DAY Klonopin (Clonazepam) C Trazodone (Trazodone) C Date:02/25/99ISR Number: 3213241-6Report Type:Periodic Company Report #JAUSA-32065 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Choreoathetosis Health Risperdal PS Janssen ORAL 3 MG 2 DAILY Hallucination Professional ORAL Mania Haldol C Depakote C Ritalin C 22-Feb-2006 08:20 AM Page: 499 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213243-XReport Type:Periodic Company Report #JAUSA-32475 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastrointestinal Disorder Consumer Risperdal PS Janssen ORAL 3 MG 1 DAILY ORAL; 4 MG DAILY ORAL Klonopin C Buspar C Paxil C Date:02/25/99ISR Number: 3213244-1Report Type:Periodic Company Report #JAUSA-34289 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Convulsion Professional (Risperidone) Sedation Janssen Tablet PS ORAL SEE IMAGE Urinary Incontinence Clozaril (Clozapine) SS ORAL SEE IMAGE Desmopressin (Desmopressin) SS INHALATION Date:02/25/99ISR Number: 3213246-5Report Type:Periodic Company Report #JAUSA-32076 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Risperdal Professional (Risperidone) PS Janssen ORAL SEE IMAGE Depakote C Effexor C Tenex C Date:02/25/99ISR Number: 3213247-7Report Type:Periodic Company Report #JAUSA-32491 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS Janssen ORAL ORAL Hyponatraemia Professional Date:02/25/99ISR Number: 3213249-0Report Type:Periodic Company Report #JAUSA-34293 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Extrapyramidal Disorder Professional (Risperidone) Janssen Tablets PS Janssen ORAL SEE IMAGE Propanolol C Sertraline C Wellbutrin C Date:02/25/99ISR Number: 3213250-7Report Type:Periodic Company Report #JAUSA-32498 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Personality Disorder Consumer Risperdal PS Janssen ORAL .5 MG 1 DAILY ORAL Buspar C 22-Feb-2006 08:20 AM Page: 500 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ritalin C Date:02/25/99ISR Number: 3213252-0Report Type:Periodic Company Report #JAUSA-32081 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Salivary Hypersecretion Professional (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Valproic Acid C Levothyroxine C Lotensin C Date:02/25/99ISR Number: 3213253-2Report Type:Periodic Company Report #JAUSA-34297 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Health Risperdal Professional (Risperidone) Janssen Tablets PS Janssen ORAL 1.5 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3213254-4Report Type:Periodic Company Report #JAUSA-32499 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Consumer Risperdal PS Janssen ORAL 1 MG 2 DAILY ORAL; 1 MG 1 DAILY ORAL 5 WK Eskalith C Verapamil C Date:02/25/99ISR Number: 3213256-8Report Type:Periodic Company Report #JAUSA-32501 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Emotional Disorder Consumer Risperdal PS Janssen ORAL 1 MG 1 DAILY Sedation ORAL Tylenol C Senokot C Date:02/25/99ISR Number: 3213258-1Report Type:Periodic Company Report #JAUSA-34301 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glaucoma Health Risperdal Professional (Risperidone) Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 1 DAILY ORAL; TAKEN AT BEDTIME Lithium C 22-Feb-2006 08:20 AM Page: 501 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213259-3Report Type:Periodic Company Report #JAUSA-32096 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Abnormal Health Risperdal Skin Ulcer Professional (Risperidone) PS Janssen ORAL TABLET, ORAL Weight Decreased Date:02/25/99ISR Number: 3213260-XReport Type:Periodic Company Report #JAUSA-32507 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Consumer Risperdal PS Janssen ORAL 4 MG 1 DAILY Hyperprolactinaemia ORAL Menstrual Disorder Date:02/25/99ISR Number: 3213262-3Report Type:Periodic Company Report #JAUSA-34302 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Toothache Health Risperdal Professional (Risperidone) ,Janssen ,Tablet PS Janssen ORAL DAILY ON A DOSE OF 1-3MG Date:02/25/99ISR Number: 3213264-7Report Type:Periodic Company Report #JAUSA-32097 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, ORAL Date:02/25/99ISR Number: 3213265-9Report Type:Periodic Company Report #JAUSA-34303 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Libido Decreased Professional (Risperidone), Janssen, Tablet PS ORAL ORAL Date:02/25/99ISR Number: 3213267-2Report Type:Periodic Company Report #JAUSA-34304 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apathy Consumer Risperdal Disturbance In Attention (Risperidone) Weight Increased Janssen Tablet PS Janssen ORAL 4MG OR 5MG FREQUENCY UNK. Date:02/25/99ISR Number: 3213269-6Report Type:Periodic Company Report #JAUSA-32508 (RSP-124) Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Consumer Risperdal PS Janssen ORAL 3 MG DAILY ORAL 22-Feb-2006 08:20 AM Page: 502 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213270-2Report Type:Periodic Company Report #JAUSA-34305 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Risperdal Hypertension (Risperidone),Jansse Hypotension n, Tablet 1 Mg PS ORAL 1 MG 1 DAILY Weight Increased ORAL Wellbutrin C Depakote C Estrogen C Prempro C Date:02/25/99ISR Number: 3213271-4Report Type:Periodic Company Report #JAUSA-34306 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Libido Decreased Consumer Risperdal (Risperidone),Jansse n, Tablet 3 Mg PS ORAL 3 MG 1 DAILY ORAL Paxil C Flomax C Tegretal C Date:02/25/99ISR Number: 3213272-6Report Type:Periodic Company Report #JAUSA-32511 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Consumer Risperdal PS Janssen ORAL 2 MG DAILY ORAL Date:02/25/99ISR Number: 3213274-XReport Type:Periodic Company Report #JAUSA-32514 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psychotic Disorder Consumer Risperdal PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3213275-1Report Type:Periodic Company Report #JAUSA-34309 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Hearing Impaired (Risperidone),Jansse n, Tablet 1 Mg PS Janssen ORAL 1.5 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3213276-3Report Type:Periodic Company Report #JAUSA-32519 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Consumer Risperdal PS Janssen ORAL .5 MG 2 DAILY Initial or Prolonged Pneumonia ORAL Weight Increased Lithium C Wellbutrin C Klonopin C Paxil C 22-Feb-2006 08:20 AM Page: 503 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213279-9Report Type:Periodic Company Report #JAUSA-34314 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Hyperprolactinaemia Professional (Risperidone), Laboratory Test Abnormal Janssen, Tablet 2 Mg PS ORAL 2 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3213280-5Report Type:Periodic Company Report #JAUSA-32536 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Consumer Risperdal PS Janssen ORAL ORAL Nausea Date:02/25/99ISR Number: 3213282-9Report Type:Periodic Company Report #JAUSA-34319 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchitis Health Risperdal Professional (Risperidone) Janssen Tablet 2 Mg PS Janssen ORAL 2 MG DAILY ORAL Mellaril C Lithium C Paxil C Date:02/25/99ISR Number: 3213283-0Report Type:Periodic Company Report #JAUSA-32537 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Consumer Risperdal PS Janssen ORAL 3 MG DAILY Involuntary ORAL Zoloft C Date:02/25/99ISR Number: 3213285-4Report Type:Periodic Company Report #JAUSA-34320 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis A Health Risperdal Professional (Risperidone) ,Janssen ,Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3213287-8Report Type:Periodic Company Report #JAUSA-34332 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal Professional (Risperidone), Janssen, Tablet PS ORAL 6 MG DAILY ORAL 22-Feb-2006 08:20 AM Page: 504 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213288-XReport Type:Periodic Company Report #JAUSA-32098 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, ORAL Date:02/25/99ISR Number: 3213289-1Report Type:Periodic Company Report #JAUSA-34333 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Health Risperdal Pain Professional (Risperidone), Janssen ,Tablet 3 Mg PS Janssen ORAL 3 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3213290-8Report Type:Periodic Company Report #JAUSA-34334 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Health Risperdal Blood Creatine Professional (Risperidone) Phosphokinase Increased ,Janssen, Tablets PS ORAL .5 MG 1 Fatigue DAILY; .5MG 2 Sedation DAILY Weight Increased Risperdal (Risperidone) SS ORAL 1MG 2 DAILY 9 WK Date:02/25/99ISR Number: 3213291-XReport Type:Periodic Company Report #JAUSA-32100 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone) PS Janssen ORAL TABLET, ORAL Date:02/25/99ISR Number: 3213292-1Report Type:Periodic Company Report #JAUSA-34335 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Abnormal Health Risperdal Professional (Risperidone) Janssen Tablet PS Janssen ORAL 6 MG 1 DAILY ORAL; TAKEN AT BEDTIME Klonopin C Lithium C Date:02/25/99ISR Number: 3213293-3Report Type:Periodic Company Report #JAUSA-34337 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Faecal Incontinence Health Risperdal Flatulence Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG 2 DAILY ORAL Atarax (Hydroxyzine) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 505 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213294-5Report Type:Periodic Company Report #JAUSA-34338 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dental Caries Health Risperdal Professional (Risperidone),Jansse n, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL; TAKEN AT BEDTIME Prozac C Lithium C Date:02/25/99ISR Number: 3213295-7Report Type:Periodic Company Report #JAUSA-34340 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal Professional (Risperidone) Janssen Tablet PS Janssen ORAL TITRATED SLOWLY 4 MG 1 DAILY Depakote C Zoloft C Date:02/25/99ISR Number: 3213296-9Report Type:Periodic Company Report #JAUSA-34647 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 2 MG 2 DAILY ORAL / 4 MG 2 DAILY ORAL 10 DAY Date:02/25/99ISR Number: 3213297-0Report Type:Periodic Company Report #JAUSA-34650 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Anxiety (Risperidone), Attention Janssen, Tablet PS Janssen ORAL ORAL 7 MON Deficit/Hyperactivity Klonopin C Disorder Lithium C Date:02/25/99ISR Number: 3213302-1Report Type:Periodic Company Report #JAUSA-34651 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL TAKES 8:00 PM 22-Feb-2006 08:20 AM Page: 506 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213308-2Report Type:Periodic Company Report #JAUSA-31297 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperdone) Janssen, Tablet PS Janssen ORAL 3 MG 2 DAILY ORAL Symmetrel C Date:02/25/99ISR Number: 3213309-4Report Type:Periodic Company Report #JAUSA-34652 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal Hyperhidrosis (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 1 DAILY ORAL / 2 MG DAILY 3 DAY Trilafon C Klonopin C Date:02/25/99ISR Number: 3213312-4Report Type:Periodic Company Report #JAUSA-31304 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Insomnia (Risperdone), Urinary Incontinence Janssen, Tablet PS Janssen ORAL 2 MG DAILY ORAL Cogentin C Date:02/25/99ISR Number: 3213316-1Report Type:Periodic Company Report #JAUSA-34653 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Candidiasis Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3213317-3Report Type:Periodic Company Report #JAUSA-31332 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Risperdal Convulsion Professional (Risperdone), Drug Abuser Janssen, Tablet PS Janssen ORAL -, ORAL Therapeutic Response Desipramine Increased (Desipramine) SS ORAL -, ORAL Date:02/25/99ISR Number: 3213322-7Report Type:Periodic Company Report #JAUSA-34656 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Torticollis Health Risperdal Initial or Prolonged Professional (Risperidone), Janssen, Tablet .5 22-Feb-2006 08:20 AM Page: 507 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mg PS Janssen ORAL .5 MG 2 DAILY ORAL / 2 MG 1 DAILY ORAL 1 DAY Megestrol C Inderal C Zantac C Date:02/25/99ISR Number: 3213323-9Report Type:Periodic Company Report #JAUSA-31348 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperdal Myalgia (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY ORAL;2 MG 2 DAILY Seroquel C Date:02/25/99ISR Number: 3213329-XReport Type:Periodic Company Report #JAUSA-31369 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Health Risperdal Professional (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG DAILY ORAL Prolixin C Date:02/25/99ISR Number: 3213332-XReport Type:Periodic Company Report #JAUSA-31370 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal Professional (Risperdone), Janssen, Tablet PS Janssen ORAL 3 MG 1 DAILY ORAL; 1.5 MG 11 DAY Date:02/25/99ISR Number: 3213336-7Report Type:Periodic Company Report #JAUSA-31371 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Condition Aggravated Professional (Risperidone), Janssen, Tablet 3 Mg PS ORAL 3 MG 2 DAILY ORAL Depakote C Date:02/25/99ISR Number: 3213341-0Report Type:Periodic Company Report #JAUSA-31372 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone),Jansse n PS Janssen ORAL 3MG 2 DAILY ORAL;2MG 2 DAILY ORAL;1 MG 1 DAILY 22-Feb-2006 08:20 AM Page: 508 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:02/25/99ISR Number: 3213344-6Report Type:Periodic Company Report #JAUSA-31373 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Amenorrhoea Professional (Risperidone), Anxiety Janssen, Tablet PS ORAL -, ORAL Galactorrhoea Cogentin C Hypertonia Visual Disturbance Date:02/25/99ISR Number: 3213347-1Report Type:Periodic Company Report #JAUSA-31374 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Insomnia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL -, ORAL Xanax C Date:02/25/99ISR Number: 3213351-3Report Type:Periodic Company Report #JAUSA-31375 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Insomnia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 8 MG DAILY ORAL Lithium C Date:02/25/99ISR Number: 3213352-5Report Type:Periodic Company Report #JAUSA-34663 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperdal (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 6 MG 1 DAILY ORAL / 3 MG DAILY Zyprexa C Fluvoxamine Maleate C Cogentin C Date:02/25/99ISR Number: 3213355-0Report Type:Periodic Company Report #JAUSA-31378 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Insomnia Professional (Risperidone), Janssen,Tablet PS Janssen ORAL 1 MG DAILY ORAL;.5 MG DAILY 22-Feb-2006 08:20 AM Page: 509 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213361-6Report Type:Periodic Company Report #JAUSA-31380 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Insomnia Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG 1 DAILY ORAL Wellbutrin C Date:02/25/99ISR Number: 3213363-XReport Type:Periodic Company Report #JAUSA-34665 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Emotional Disorder (Risperidone), Hyperreflexia Janssen, Tablet 1 Mg PS Janssen ORAL .5 MG 2 DAILY Pyrexia ORAL Tachycardia Cogentin C Thirst Tremor Date:02/25/99ISR Number: 3213365-3Report Type:Periodic Company Report #JAUSA-31381 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Insomnia Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL Paxil C ... C ... C Date:02/25/99ISR Number: 3213368-9Report Type:Periodic Company Report #JAUSA-31382 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Insomnia Professional (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG DAILY ORAL Effexor C Date:02/25/99ISR Number: 3213369-0Report Type:Periodic Company Report #JAUSA-34666 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Consumer Risperdal Libido Decreased (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY ORAL Depakote C Wellbutrin C Cogentin C Fortovase C Norvir C Azt C 22-Feb-2006 08:20 AM Page: 510 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rescriptor C Compazine C Claritin-D C Date:02/25/99ISR Number: 3213372-0Report Type:Periodic Company Report #JAUSA-31383 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3213374-4Report Type:Periodic Company Report #JAUSA-31384 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG DAILY ORAL Date:02/25/99ISR Number: 3213375-6Report Type:Periodic Company Report #JAUSA-34669 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Consumer Risperdal Deficit/Hyperactivity (Risperidone), Disorder Janssen, Tablet PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3213379-3Report Type:Periodic Company Report #JAUSA-31386 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal Professional (Risperidone), Janssen PS ORAL 3 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3213381-1Report Type:Periodic Company Report #JAUSA-34670 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Risperdal Pallor Professional (Risperidone), Thirst Janssen, Tablet PS Janssen ORAL ORAL 6 WK Date:02/25/99ISR Number: 3213383-5Report Type:Periodic Company Report #JAUSA-31388 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Discharge Health Risperdal Professional (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG DAILY ORAL 22-Feb-2006 08:20 AM Page: 511 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213385-9Report Type:Periodic Company Report #JAUSA-34671 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal Professional (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG 2 DAILY ORAL Klonopin C Date:02/25/99ISR Number: 3213387-2Report Type:Periodic Company Report #JAUSA-31394 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Initial or Prolonged Syndrome Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 2 DAILY ORAL;2 MG 2 DAILY ORAL 4 DAY Date:02/25/99ISR Number: 3213388-4Report Type:Periodic Company Report #JAUSA-35074 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Risperdal Condition Aggravated Professional (Risperidone), Leukopenia Janssen, Tablet 3 Mg PS ORAL 3 MG 1 DAILY Thrombocytopenia ORAL Date:02/25/99ISR Number: 3213390-2Report Type:Periodic Company Report #JAUSA-34676 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal Pigmentation Disorder Professional (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3213392-6Report Type:Periodic Company Report #JAUSA-35076 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet PS ORAL ORAL Lithobid (Lithium) C Date:02/25/99ISR Number: 3213395-1Report Type:Periodic Company Report #JAUSA-34677 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen ORAL ORAL Professional 22-Feb-2006 08:20 AM Page: 512 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213396-3Report Type:Periodic Company Report #JAUSA-35077 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL .5 MG 2 DAILY ORAL Digitalis C Aspirin C Date:02/25/99ISR Number: 3213399-9Report Type:Periodic Company Report #JAUSA-35085 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Health Risperdal Initial or Prolonged Hypertension Professional (Risperidone), Nervousness Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG 1 DAILY Suicide Attempt ORAL AT Tachycardia BEDTIME Tremor Depakote (Valproate Sodium) Tablet 500 Mg SS ORAL 500 MG 1 DAILY ORAL IN THE MORNING Date:02/25/99ISR Number: 3213402-6Report Type:Periodic Company Report #JAUSA-34679 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Increased Appetite Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Weight Increased Professional ORAL Ritalin C Date:02/25/99ISR Number: 3213403-8Report Type:Periodic Company Report #JAUSA-35089 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3213405-1Report Type:Periodic Company Report #JAUSA-34680 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Professional ORAL Date:02/25/99ISR Number: 3213406-3Report Type:Periodic Company Report #JAUSA-35090 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL .5 MG 1 DAILY 22-Feb-2006 08:20 AM Page: 513 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:02/25/99ISR Number: 3213410-5Report Type:Periodic Company Report #JAUSA-35091 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Health Risperdal Initial or Prolonged Anaemia Professional (Risperidone), Condition Aggravated Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 2 DAILY Leukopenia ORAL; SEE IMAGE Benadryl C Date:02/25/99ISR Number: 3213411-7Report Type:Periodic Company Report #JAUSA-34682 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Increased Appetite Health Risperdal PS Janssen ORAL .5 MG 2 DAILY Weight Increased Professional ORAL Depakote C Ritalin C C Date:02/25/99ISR Number: 3213413-0Report Type:Periodic Company Report #JAUSA-35107 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eye Disorder Health Risperdal Initial or Prolonged Glossitis Professional (Risperidone), Salivary Hypersecretion Janssen, Tablet 1 Mg PS Janssen ORAL .5 MG 2 DAILY Tongue Oedema ORAL; 2 DOSES GIVEN Effexor (Venlafexine) Tablet SS ORAL ORAL Date:02/25/99ISR Number: 3213417-8Report Type:Periodic Company Report #JAUSA-35112 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Risperdal Initial or Prolonged Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1MG 2 DAILY ORAL; 4 DOSES GIVEN Zyprexa (Olanzapine) Tablet SS ORAL ORAL Date:02/25/99ISR Number: 3213418-XReport Type:Periodic Company Report #JAUSA-34685 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Risperdal (Risperidone), Janssen, Tablet PS Janssen ORAL 4 MG 1 DAILY ORAL Depakote (Valproate Sodium) Tablet 500 Mg SS ORAL 500 MG 2 22-Feb-2006 08:20 AM Page: 514 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAILY ORAL Prolixin C Cogentin C Date:02/25/99ISR Number: 3213420-8Report Type:Periodic Company Report #JAUSA-35125 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Risperdal Professional (Risperidone), Janssen Tablet PS Janssen ORAL ORAL Klonopin (Clonazepam) Tablet SS ORAL ORAL Paxil (Paroxetine) SS ORAL TABLET ORAL Wellbutrin (Amfebutamone) SS TABLET Date:02/25/99ISR Number: 3213422-1Report Type:Periodic Company Report #JAUSA-34769 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Risperdal PS Janssen ORAL 6 MG SINGLE Professional ORAL / 1 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3213425-7Report Type:Periodic Company Report #JAUSA-35137 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3213428-2Report Type:Periodic Company Report #JAUSA-34770 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Health Risperdal Initial or Prolonged Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL / 11 MG 1 SINGLE ORAL Depakote C Anafranil C Date:02/25/99ISR Number: 3213429-4Report Type:Periodic Company Report #JAUSA-35140 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 2 DAILY ORAL 22-Feb-2006 08:20 AM Page: 515 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213432-4Report Type:Periodic Company Report #JAUSA-35150 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Consumer Risperdal Hepatitis (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3213435-XReport Type:Periodic Company Report #JAUSA-35152 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL; 2 MG 2 DAILY 11 DAY Bactrim Ds C Zoloft C Dilantin C Depakote C Pepcid C Combivir C Crixivan C Mycelex C Date:02/25/99ISR Number: 3213439-7Report Type:Periodic Company Report #JAUSA-35155 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Health Risperdal Hyperprolactinaemia Professional (Risperidone), Libido Decreased Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL Luvox C Date:02/25/99ISR Number: 3213442-7Report Type:Periodic Company Report #JAUSA-35157 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Risperdal Condition Aggravated (Risperidone), Depression Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 3 DAILY Gout ORAL; .5MG 1 DAILY Allopurinol C Niacin C Colace C Fibercon C Multivit C Demadex C K-Dur C Aricept C Insulin, Regular C Rezulin C Celexa C 22-Feb-2006 08:20 AM Page: 516 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213443-9Report Type:Periodic Company Report #JAUSA-35159 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothermia Health Risperdal Professional (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY ORAL Cogentin C Ativan C Inderal C Vasotec C Date:02/25/99ISR Number: 3213447-6Report Type:Periodic Company Report #JAUSA-35165 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Tremor Professional (Risperidone), Weight Increased Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG 2 DAILY ORAL; 1 MG 2 DAILY Date:02/25/99ISR Number: 3213448-8Report Type:Periodic Company Report #JAUSA-31115 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coagulopathy Health Risperdal Initial or Prolonged Laboratory Test Abnormal Professional (Risperidone) PS Janssen ORAL 2MG 1 DAILY Phlebitis ORAL; 4 MG DAILY AS NEEDED Depakote C Wellbutrin C Date:02/25/99ISR Number: 3213450-6Report Type:Periodic Company Report #JAUSA-35166 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acute Psychosis Consumer Risperdal Condition Aggravated (Risperidone), Janssen, Tablet PS Janssen ORAL ORAL Depakote C Ativan C Date:02/25/99ISR Number: 3213452-XReport Type:Periodic Company Report #JAUSA-35167 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 6 MG DAILY ORAL Lithium C Depakene C 22-Feb-2006 08:20 AM Page: 517 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213453-1Report Type:Periodic Company Report #JAUSA-31152 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Mouth Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3213455-5Report Type:Periodic Company Report #JAUSA-31153 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tachycardia Consumer Risperdal Initial or Prolonged Urinary Incontinence (Risperidone) PS Janssen ORAL 1MG 2 DAILY ORAL; 1MG IN THE AM 1 MG IN THE PM; 3MG 2 DAILY 3 Micronase C Verapamil C Date:02/25/99ISR Number: 3213457-9Report Type:Periodic Company Report #JAUSA-31156 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Risperdal Anorexia (Risperidone) PS ORAL ORAL Dizziness Dyspnoea Muscular Weakness Nervousness Sedation Tremor Date:02/25/99ISR Number: 3213460-9Report Type:Periodic Company Report #JAUSA-31163 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Consumer Risperdal (Risperidone) PS Janssen ORAL 3MG 1 DAILY ORAL Date:02/25/99ISR Number: 3213462-2Report Type:Periodic Company Report #JAUSA-31168 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Risperdal (Risperidone) PS Janssen ORAL .5MG 2 DAILY ORAL Insulin C Date:02/25/99ISR Number: 3213468-3Report Type:Periodic Company Report #JAUSA-31171 Age:32 YR Gender:Female I/FU:I Outcome PT Other Condition Aggravated Palpitations Upper Respiratory Tract 22-Feb-2006 08:20 AM Page: 518 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Infection Report Source Product Role Manufacturer Route Dose Duration Health Risperdal Professional (Risperidone) PS Janssen ORAL 4MG 2 DAILY ORAL; ESTIMATED TREATMENT MONTH AND DAY Prozac C Nyquil C Date:02/25/99ISR Number: 3213471-3Report Type:Periodic Company Report #JAUSA-31173 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 2MG DAILY ORAL Date:02/25/99ISR Number: 3213475-0Report Type:Periodic Company Report #JAUSA-31176 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematemesis Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3213480-4Report Type:Periodic Company Report #JAUSA-31177 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 6MG DAILY ORAL; 4MG IN AM, 2MG IN PM Tegretol C Date:02/25/99ISR Number: 3213483-XReport Type:Periodic Company Report #JAUSA-31178 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematuria Health Risperdal Professional (Risperidone) PS Janssen ORAL 2 MG 2 DAILY ORAL; 2MG IN AM, 2 MG IN PM Date:02/25/99ISR Number: 3213490-7Report Type:Periodic Company Report #JAUSA-31179 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL DAILY, ORAL; ONE TABLET 22-Feb-2006 08:20 AM Page: 519 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213493-2Report Type:Periodic Company Report #JAUSA-31181 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Libido Decreased Consumer Risperdal (Risperidone) PS Janssen ORAL 2MG 1 DAILY ORAL: 2MG ALT DAY ORAL Nasal Spray C Zoloft C Buspar C Date:02/25/99ISR Number: 3213499-3Report Type:Periodic Company Report #JAUSA-31231 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Study Risperdal Initial or Prolonged Drug Abuser Health (Risperidone) PS Janssen ORAL 3MG 2 DAILY Professional ORAL Navane (Tiotixene) SS ORAL 5MG ORAL 21 DAY Verapamil SS 1 TABLET 1 DAY Date:02/25/99ISR Number: 3213503-2Report Type:Periodic Company Report #JAUSA-31240 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal Decreased Professional (Risperidone) PS Janssen ORAL 3MG 2 DAILY ORAL Benztropine C Hydrochlorothiazide C Klonopin C Date:02/25/99ISR Number: 3213506-8Report Type:Periodic Company Report #JAUSA-31266 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3213510-XReport Type:Periodic Company Report #JAUSA-31273 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Consumer Risperdal Visual Disturbance (Risperidone) PS Janssen ORAL 3MG 2 DAILY Weight Increased ORAL; ESTIMATED START DATE Date:02/25/99ISR Number: 3213513-5Report Type:Periodic Company Report #JAUSA-31276 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Health Risperdal Initial or Prolonged Pyrexia Professional (Risperidone) PS Janssen ORAL .5MG 2 DAILY ORAL 22-Feb-2006 08:20 AM Page: 520 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C Date:02/25/99ISR Number: 3213517-2Report Type:Periodic Company Report #JAUSA-31277 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Health Risperdal Involuntary Professional (Risperidone) PS Janssen ORAL 1MG 1 DAILY ORAL 3 YR Date:02/25/99ISR Number: 3213521-4Report Type:Periodic Company Report #JAUSA-31278 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Disorder Health Risperdal Initial or Prolonged Condition Aggravated Professional (Risperidone) PS Janssen ORAL 1.5 MG DAILY Hypertension ORAL Lithium C Mellaril C Effexor C Hytrin C Date:02/25/99ISR Number: 3213528-7Report Type:Periodic Company Report #JAUSA-35219 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Disorder Health Risperdal Initial or Prolonged Coma Professional (Risperidone) PS Janssen ORAL .5 MG 1 DAILY ORAL Haldol (Haloperidol) C Tegretol (Carbamezipine) C Date:02/25/99ISR Number: 3213532-9Report Type:Periodic Company Report #JAUSA-35226 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Nausea (Risperidone) PS Janssen ORAL 2 MG DAILY ORAL; .5 MG 1 DAILY ORAL Luvox (Fluvoxamine) C Date:02/25/99ISR Number: 3213534-2Report Type:Periodic Company Report #JAUSA-35227 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Health Risperdal Professional (Risperidone) PS Janssen ORAL 3 MG 1 DAILY ORAL Pravachol (Pravastatin) C Micronase (Glibenclamide) C Artane (Trihexyphenidyl) C 22-Feb-2006 08:20 AM Page: 521 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213538-XReport Type:Periodic Company Report #JAUSA-35234 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Diabetes Mellitus Professional (Risperidone) PS Janssen ORAL 6 MG 1 DAILY Renal Impairment ORAL Glucotrol (Glipizide) C Date:02/25/99ISR Number: 3213540-8Report Type:Periodic Company Report #JAUSA-35239 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal Professional (Risperidone) PS Janssen ORAL .5 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3213544-5Report Type:Periodic Company Report #JAUSA-35255 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thirst Health Risperdal Weight Increased Professional (Risperidone) PS Janssen ORAL 2 MG 2 DAILY ORAL Eskalith (Lithium) Tablet SS ORAL 450 MG 3 DAILY ORAL Paxil (Paroxetine) SS ORAL 20 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3213548-2Report Type:Periodic Company Report #JAUSA-35256 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL; 2 MG 2 DAILY ORAL; 1 MG 2 DAILY ORAL 21 DAY Date:02/25/99ISR Number: 3213551-2Report Type:Periodic Company Report #JAUSA-35257 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Risperdal Sedation (Risperidone) PS Janssen ORAL 1 MG 4 DAILY ORAL Date:02/25/99ISR Number: 3213554-8Report Type:Periodic Company Report #JAUSA-35259 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Risperdal (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL 22-Feb-2006 08:20 AM Page: 522 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Darvon (Dextropropoxyphene) C Zoloft (Sertraline) C Date:02/25/99ISR Number: 3213557-3Report Type:Periodic Company Report #JAUSA-35260 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Consumer Risperdal (Risperidone) PS Janssen ORAL 1.5 MG DAILY ORAL Diabeta (Glibenclamide) C Prevacid (Lansoprazole) C Date:02/25/99ISR Number: 3213562-7Report Type:Periodic Company Report #JAUSA-35261 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Consumer Risperdal Menstrual Disorder (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Zoloft (Sertraline) C Cogentin (Benztropine) C Date:02/25/99ISR Number: 3213567-6Report Type:Periodic Company Report #JAUSA-35270 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone) PS Janssen ORAL .5 MG 1 DAILY ORAL 3 WK Tranxene (Clorazepate) C Prozac (Fluoxetine) C Date:02/25/99ISR Number: 3213569-XReport Type:Periodic Company Report #JAUSA-35276 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 3 DAILY ORAL; DAILY ORAL 7 WK Date:02/25/99ISR Number: 3213573-1Report Type:Periodic Company Report #JAUSA-35277 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 2 MG 2 DAILY ORAL 8 WK Adderall (Adderall 22-Feb-2006 08:20 AM Page: 523 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (R)) C Clonidine (Clonidine) C Date:02/25/99ISR Number: 3213578-0Report Type:Periodic Company Report #JAUSA-35285 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Health Risperdal Initial or Prolonged Confusional State Professional (Risperidone) PS Janssen ORAL .5 MG 2 DAILY Dyspnoea ORAL; .5 MG 1 Neuroleptic Malignant DAILY ORAL 3 DAY Syndrome Zyprexa (Olanzapine) Sedation Tablet 5 Mg SS ORAL 5 MG 2 DAILY Tachycardia ORAL Date:02/25/99ISR Number: 3213582-2Report Type:Periodic Company Report #JAUSA-35296 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Dyspnoea Professional (Risperidone) PS Janssen ORAL 1 MG 1 DAILY Dystonia ORAL; 2 MG 1 Oculogyration DAILY; 3 MG 1 Salivary Hypersecretion DAILY; 4 MG 1 Tongue Paralysis DAILY; 2 MG 1 6 DAY Benadryl (Diphenhydramine) C Date:02/25/99ISR Number: 3213586-XReport Type:Periodic Company Report #JAUSA-35332 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Risperdal Professional (Risperidone) PS Janssen ORAL .5 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3213590-1Report Type:Periodic Company Report #JAUSA-35333 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ovarian Cyst Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3213592-5Report Type:Periodic Company Report #JAUSA-35336 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Consumer Risperdal (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL 22-Feb-2006 08:20 AM Page: 524 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213596-2Report Type:Periodic Company Report #JAUSA-35338 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Consumer Risperdal Sedation (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL; .5 MG 1 DAILY; 1 MG 1 DAILY 55 WK Synthroid (Levothyroxine) C Vitam. B12 (Vitam. B12) C Date:02/25/99ISR Number: 3213866-8Report Type:Periodic Company Report #JAUSA-35168 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Hyperprolactinaemia Professional (Risperidone) Menstrual Disorder Janssen, Tablet PS ORAL ORAL Depakote C Date:02/25/99ISR Number: 3213874-7Report Type:Periodic Company Report #JAUSA-35169 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Health Risperdal Paranoia Professional (Risperidone) Janssen, Tablet 1 Mg PS ORAL 1.5 MG 1 DAILY ORAL; 1MG 2 DAILY Date:02/25/99ISR Number: 3213885-1Report Type:Periodic Company Report #JAUSA-35170 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal Thrombocytopenia Professional (Risperidone) Janssen, Tablet PS ORAL 8 MG DAILY ORAL, TAKEN AT BEDTIME Date:02/25/99ISR Number: 3213890-5Report Type:Periodic Company Report #JAUSA-35171 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Consumer Risperdal Hyperventilation (Risperidone) Insomnia Janssen, Tablet 3 Mg PS ORAL 3 MG 2 DAILY Thirst ORAL (1 IN AM, 1 AT BEDTIME); 6MG 1 DAILY Risperdal (Risperidone) SS ORAL 6 MG 1 DAILY 22-Feb-2006 08:20 AM Page: 525 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213895-4Report Type:Periodic Company Report #JAUSA-35172 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhinitis Health Risperdal Professional (Risperidone) Janssen, Tablet PS ORAL 6 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3213900-5Report Type:Periodic Company Report #JAUSA-35173 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone) Janssen, Tablet 1 Mg PS ORAL .5 MG 1 DAILY ORAL Luvox C Date:02/25/99ISR Number: 3213907-8Report Type:Periodic Company Report #JAUSA-35174 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal Weight Increased (Risperidone) Janssen, Tablet 1 Mg PS ORAL .5 MG 1 DAILY ORAL Wellbutrin Sr C Zoloft C Xanax C Aspirin C Zestoretic C Vitamin E C Metamucil C Date:02/25/99ISR Number: 3213916-9Report Type:Periodic Company Report #JAUSA-35175 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Consumer Risperdal (Risperidone) Janssen, Tablet PS ORAL ORAL Date:02/25/99ISR Number: 3213921-2Report Type:Periodic Company Report #JAUSA-35176 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blepharospasm Health Risperdal Eyelid Ptosis Professional (Risperidone) Strabismus Janssen, Tablet 3 Mg PS ORAL 3 MG 1 DAILY Visual Disturbance ORAL AT BEDTIME Risperdal (Risperidone) SS ORAL 2 MG 1 DAILY AT BEDTIME 7 WK Risperdal (Risperidone) SS ORAL 1 MG 1 DAILY AT BEDTIME 4 WK 22-Feb-2006 08:20 AM Page: 526 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal (Risperidone) SS ORAL .5 MG 1 DAILY AT BEDTIME 7 DAY Paxil (Paroxetine) Tablet 10 Mg SS ORAL 10 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3213927-3Report Type:Periodic Company Report #JAUSA-35178 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Pain Health Risperdal Gynaecomastia Professional (Risperidone) Janssen, Tablet 1 Mg PS ORAL 1 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3213934-0Report Type:Periodic Company Report #JAUSA-35179 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Consumer Risperdal Abnormal (Risperidone) Janssen, Tablet 2 Mg PS ORAL 2 MG 1 DAILY ORAL Nortriptyline C Sertraline C Date:02/25/99ISR Number: 3213942-XReport Type:Periodic Company Report #JAUSA-35180 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Health Risperdal Professional (Risperidone) Janssen, Tablet 4 Mg PS ORAL 4 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3213949-2Report Type:Periodic Company Report #JAUSA-35182 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Function Abnormal Health Risperdal Professional (Risperidone) Janssen, Tablet 1 Mg PS ORAL 1 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3213957-1Report Type:Periodic Company Report #JAUSA-35186 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Nightmare Professional (Risperidone) Suicide Attempt Janssen, Tablet PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 527 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3213962-5Report Type:Periodic Company Report #JAUSA-35191 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Health Risperdal Confusional State Professional (Risperidone) Janssen, Tablet 1 Mg PS ORAL 1.5 MG 1 DAILY ORAL Zoloft (Sertraline) Tablet 100 Mg SS ORAL 100 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3213969-8Report Type:Periodic Company Report #JAUSA-35192 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Risperdal Initial or Prolonged Professional (Risperidone) Janssen, Tablet 1 Mg PS ORAL 1 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3213975-3Report Type:Periodic Company Report #JAUSA-35193 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Hypoaesthesia (Risperidone)Janssen Paraesthesia , Tablet PS ORAL ORAL Date:02/25/99ISR Number: 3214001-2Report Type:Periodic Company Report #JAUSA-35194 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Flushing Professional (Risperidone) Hypertrophy Breast Janssen, Tablet 1 Mg PS ORAL .5 MG 2 DAILY Weight Increased ORAL Risperdal (Risperidone) SS ORAL .5 MG 2 DAILY Zyprexa (Olanzapine) Tablet SS ORAL ORAL Date:02/25/99ISR Number: 3214008-5Report Type:Periodic Company Report #JAUSA-35201 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Laboratory Test Abnormal Health Risperdal Initial or Prolonged Neuroleptic Malignant Professional (Risperidone) Syndrome Janssen, Tablet PS ORAL 10 MG DAILY Tongue Ulceration ORAL Urinary Incontinence Risperdal (Risperidone) SS ORAL 10 MG DAILY; 4MG IN AM , 6MG IN PM 14 DAY Imipramine C 22-Feb-2006 08:20 AM Page: 528 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3214014-0Report Type:Periodic Company Report #JAUSA-35215 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) Janssen, Tablet 1 Mg PS ORAL 1 MG 2 DAILY ORAL Risperdal (Risperidone) SS ORAL 2 MG 2 DAILY 3 DAY Risperdal (Risperidone) SS ORAL 3 MG 2 DAILY 9 DAY Risperdal (Risperidone) SS ORAL 4 MG 2 DAILY 5 DAY Date:02/25/99ISR Number: 3214024-3Report Type:Periodic Company Report #JAUSA-34133 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Risperdal Professional (Risperidone), Janssen, Tablet PS ORAL 2 MG DAILY; APPROXIMATELY ONE WEEK 1 WK Adderall (Adderall (R) ) C Depakote (Valproate Sodium) C Date:02/25/99ISR Number: 3214027-9Report Type:Periodic Company Report #JAUSA-34137 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal Deficit/Hyperactivity Professional (Risperidone), Disorder Janssen, Tablet PS ORAL 4 MG DAILY Tardive Dyskinesia Ritalin Weight Increased (Methylphenidate) C Zoloft (Sertraline) C Date:02/25/99ISR Number: 3214030-9Report Type:Periodic Company Report #JAUSA-34139 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Precocious Puberty Health Risperdal Professional (Risperidone), Janssen, Tablet PS ORAL 1 MG DAILY; APPROXIMATELY 2 YEARS Zoloft (Sertraline) C Date:02/25/99ISR Number: 3214033-4Report Type:Periodic Company Report #JAUSA-34153 Age:48 YR Gender:Female I/FU:I Outcome PT Other Abdominal Distension Hearing Impaired Hypertrophy Breast 22-Feb-2006 08:20 AM Page: 529 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lymphadenopathy Tinnitus Report Source Product Role Manufacturer Route Dose Duration Health Risperdal Professional (Risperidone), Janssen, Tablet PS ORAL 0.5MG TO 1MG DAILY. START DATE APPROXIMATELY 2 YEARS AGO. Date:02/25/99ISR Number: 3214038-3Report Type:Periodic Company Report #JAUSA-34156 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Professional (Risperidone), Janssen, Tablet PS ORAL 4 MG DAILY; APPROXIMATELY ONE YEAR AGO. ESTIMATED DATE Cogentin (Benztropine) C Fioricet (Fioricet (R) ) C Ativan (Lorazepam) C Date:02/25/99ISR Number: 3214040-1Report Type:Periodic Company Report #JAUSA-34158 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Mania Professional (Risperidone), Janssen, Tablet PS ORAL 2 MG 2 DAILY Risperdal (Risperidone) SS ORAL 3 MG 2 DAILY 5 DAY Cogentin (Benztropine) C Lithium (Lithium) C Multivit (Multivit (R) ) C Ortho-Novum (Otho-Novum (R) ) C Date:02/25/99ISR Number: 3214041-3Report Type:Periodic Company Report #JAUSA-34162 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Schizophrenia Professional (Risperidone), Janssen, Tablet PS ORAL 3 MG 2 DAILY Risperdal (Risperidone) SS ORAL 4 MG 2 DAILY 10 DAY Cogentin (Benztropine) C Lithium (Lithium) C 22-Feb-2006 08:20 AM Page: 530 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3214044-9Report Type:Periodic Company Report #JAUSA-34163 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone), Janssen, Tablet PS ORAL 2 MG 2 DAILY Zoloft (Sertraline) C Leukotrol (Mirimostim) C Insulin (Insulin, Unspec) C Date:02/25/99ISR Number: 3214048-6Report Type:Periodic Company Report #JAUSA-34165 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperaesthesia Health Risperdal Paraesthesia Professional (Risperidone), Janssen, Tablet PS ORAL 2 MG 2 DAILY Date:02/25/99ISR Number: 3214049-8Report Type:Periodic Company Report #JAUSA-34176 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hearing Impaired Consumer Risperdal Tinnitus (Risperidone), Janssen, Tablet PS ORAL .5 MG 1 DAILY; TAKE AT HS. Thyroid (Thyroid) C Premarin (Estogens Conjugated) C Cycrin (Medroxyprogesterone ) C Talwin (Pentazocine) C Valium (Diazepam) C Date:02/25/99ISR Number: 3214064-4Report Type:Periodic Company Report #JAUSA-34177 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Risperdal (Risperidone), Janssen, Tablet PS ORAL .5 MG DAILY; SEE IMAGE Topamax (Topiramate) C Date:02/25/99ISR Number: 3214066-8Report Type:Periodic Company Report #JAUSA-34178 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Deposits Health Risperdal Professional (Risperidone), Janssen, Tablet PS ORAL 3 MG 1 DAILY; TAKEN AT BEDTIME 22-Feb-2006 08:20 AM Page: 531 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3214069-3Report Type:Periodic Company Report #JAUSA-34179 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Consumer Risperdal Erectile Dysfunction (Risperidone), Janssen, Tablet PS ORAL 4 MG 2 DAILY; 1 TAB IN AM; 1 TAB AT BEDTIME Depakote (Valproate Sodium) C Artane (Trihexyphenidyl) C Klonopin (Clonazepam) C Tegretol (Carbamazepine) C Date:02/25/99ISR Number: 3214237-0Report Type:Periodic Company Report #9815075 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Consumer Zoloft Tablets PS ORAL 50.00 MG Emotional Disorder TOTAL:DAILY:O Headache RAL Paraesthesia Risperdal SS ORAL 1.00 MG Thinking Abnormal TOTAL:DAILY:O RAL Date:02/25/99ISR Number: 3214570-2Report Type:Periodic Company Report #JAUSA-34908 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL; ESTIMATED START DATE Date:02/25/99ISR Number: 3214572-6Report Type:Periodic Company Report #JAUSA-34909 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Delirium Professional (Risperidone) PS Janssen ORAL -, ORAL ; ESTIMATED START DATE Atenol C Hydrochlorothiazide C Date:02/25/99ISR Number: 3214574-XReport Type:Periodic Company Report #JAUSA-34910 Age:20 YR Gender:Male I/FU:I Outcome PT Other Increased Appetite Myalgia Rhinitis 22-Feb-2006 08:20 AM Page: 532 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal (Risperidone) PS Janssen ORAL SEE IMAGE Date:02/25/99ISR Number: 3214577-5Report Type:Periodic Company Report #JAUSA-34918 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Risperdal Hypotension (Risperidone) PS Janssen ORAL .25 MG 1 Sedation DAILY ORAL Tachycardia Date:02/25/99ISR Number: 3214581-7Report Type:Periodic Company Report #JAUSA-34920 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Risperdal Initial or Prolonged Fatigue Professional (Risperidone) PS Janssen ORAL 1 MG 1 DAILY Hallucination ORAL ; 3 MG Thinking Abnormal 1DAILY ORAL Date:02/25/99ISR Number: 3214583-0Report Type:Periodic Company Report #JAUSA-34926 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Consumer Risperdal Initial or Prolonged Suicide Attempt (Risperidone) PS Janssen ORAL SEE IMAGE Tremor Zyprexa C Neurontin C Lamietyl C Cogentin C Inderal C Date:02/25/99ISR Number: 3214586-6Report Type:Periodic Company Report #JAUSA-34943 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Health Risperdal Asthenia Professional (Risperidone) PS Janssen ORAL SEE IMAGE Condition Aggravated Desyrel C Dizziness Serzone C Dyspepsia Doxepin C Epistaxis Ativan C Flushing Sedation Date:02/25/99ISR Number: 3214592-1Report Type:Periodic Company Report #JAUSA-34945 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mania Health Risperdal Professional (Risperidone) PS Janssen ORAL 4 MG 1 DAILY ORAL 22-Feb-2006 08:20 AM Page: 533 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3214594-5Report Type:Periodic Company Report #JAUSA-34946 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Skin Odour Abnormal Health Risperdal Professional (Risperidone) PS Janssen ORAL 2 MG 3 DAILY ORAL; ESTIMATED START DATE Luvox C Date:02/25/99ISR Number: 3214597-0Report Type:Periodic Company Report #JAUSA-34948 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone) PS Janssen ORAL .5 MG 2 DAILY ORAL ; ESTIMATED START DATE Effexor C Date:02/25/99ISR Number: 3214599-4Report Type:Periodic Company Report #JAUSA-34950 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Dreams Consumer Risperdal Asthenia (Risperidone) PS Janssen ORAL SEE IMAGE Confusional State Sulfasalazine C Constipation Phenylpropanolamine C Dizziness Postural Dry Mouth Fatigue Hypertonia Hypotension Libido Decreased Malaise Sedation Visual Disturbance Weight Increased Date:02/25/99ISR Number: 3214602-1Report Type:Periodic Company Report #JAUSA-34955 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urine Abnormality Health Risperdal Professional (Risperidone) PS Janssen ORAL 6 MG DAILY ORAL; ESTIMATED DATE Zoloft C Date:02/25/99ISR Number: 3214604-5Report Type:Periodic Company Report #JAUSA-34956 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL 22-Feb-2006 08:20 AM Page: 534 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3214606-9Report Type:Periodic Company Report #JAUSA-34974 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pupillary Reflex Impaired Health Risperdal Initial or Prolonged Stupor Professional (Risperidone) PS Janssen ORAL SEE IMAGE Restoril (Temazepam) SS ORAL 30 MG ORAL Paxil SS ORAL 20 MG 1 DAILY ; ORAL Antibiot. Unspec. C Date:02/25/99ISR Number: 3214607-0Report Type:Periodic Company Report #JAUSA-35001 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL; ESTIMATED START DATE Date:02/25/99ISR Number: 3214609-4Report Type:Periodic Company Report #JAUSA-35004 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL ORAL , DOSAGE Lactation Puerperal / DURATION Increased UNKNOWN Paxil C Depakote C Depo-Provera C Date:02/25/99ISR Number: 3214612-4Report Type:Periodic Company Report #JAUSA-35006 Age:5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertrophy Breast Consumer Risperdal Increased Appetite (Risperidone) PS Janssen ORAL SEE IMAGE Weight Increased Depakote C Tegretol C Neurotin C Clonidine C Date:02/25/99ISR Number: 3214614-8Report Type:Periodic Company Report #JAUSA-35007 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Consumer Risperdal Illusion (Risperidone) PS Janssen ORAL 3 MG 1 DAILY Weight Increased ORAL Neurontin C 22-Feb-2006 08:20 AM Page: 535 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3214617-3Report Type:Periodic Company Report #JAUSA-35021 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL TAKEN AT NIGHT. Paxil C Date:02/25/99ISR Number: 3214619-7Report Type:Periodic Company Report #JAUSA-35022 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhinitis Health Risperdal Professional (Risperidone) PS Janssen ORAL SEE IMAGE Prolixin C Date:02/25/99ISR Number: 3216024-6Report Type:Periodic Company Report #JAUSA-34802 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Health Risperdal Professional (Risperidone) PS ORAL 1 MG 2 DAILY ORAL Trazodone C Celex C Date:02/25/99ISR Number: 3216029-5Report Type:Periodic Company Report #JAUSA-34876 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Consumer Risperdal Increased Appetite (Risperidone) PS Janssen ORAL 2 MG I DAILY Nervousness ORAL Eskalith C Date:02/25/99ISR Number: 3216033-7Report Type:Periodic Company Report #JAUSA-34879 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal (Risperidone) PS Janssen ORAL 3 MG DAILY ORAL Zoloft C Date:02/25/99ISR Number: 3216038-6Report Type:Periodic Company Report #JAUSA-34903 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal Professional (Risperidone) PS Janssen ORAL 5 MG 2 DAILY ORAL 22-Feb-2006 08:20 AM Page: 536 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3216041-6Report Type:Periodic Company Report #JAUSA-34906 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Health Risperdal Hyperprolactinaemia Professional (Risperidone) PS Janssen ORAL 5 MG 2 DAILY Weight Increased ORAL Risperdal (Risperidone) SS Luvox C Date:02/25/99ISR Number: 3216044-1Report Type:Periodic Company Report #JAUSA-34886 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3216047-7Report Type:Periodic Company Report #JAUSA-34887 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal Professional (Risperidone) PS Janssen ORAL 5 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3216051-9Report Type:Periodic Company Report #JAUSA-34888 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal Professional (Risperidone) PS Janssen ORAL 5 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3216055-6Report Type:Periodic Company Report #JAUSA-34889 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal Professional (Risperidone) 1 Mg PS ORAL 5 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3216061-1Report Type:Periodic Company Report #JAUSA-34823 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Risperdal Increased Professional (Risperidone) PS ORAL 5 MG 1 DAILY Aspartate ORAL Aminotransferase Risperdal Increased (Risperidone) SS ORAL 1 MG 1 DAILY Gamma-Glutamyltransferase ORAL 14 DAY Increased Hepatomegaly 22-Feb-2006 08:20 AM Page: 537 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3216065-9Report Type:Periodic Company Report #JAUSA-34804 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperdal (Risperidone) PS Janssen ORAL 1.5 MG 2 DAILY ORAL Hydrochlorothoazide C Lodine C Nitro C Date:02/25/99ISR Number: 3216069-6Report Type:Periodic Company Report #JAUSA-34806 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Hyperprolactinaemia (Risperidone) PS ORAL 4 MG 1 DAILY Weight Increased ORAL Risperdal (Risperidone) SS Antidepressant SS Klonopin C Date:02/25/99ISR Number: 3216074-XReport Type:Periodic Company Report #JAUSA-34808 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apathy Consumer Risperdal Condition Aggravated (Risperidone) PS Janssen ORAL 14 MG 1 DAILY ORAL Risperdal (Risperidone) SS Risperdal (Risperidone) SS ORAL 2 MG DAILY ORAL Date:02/25/99ISR Number: 3216078-7Report Type:Periodic Company Report #JAUSA-34839 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Neoplasm Male Health Risperdal Professional (Risperidone) PS Janssen ORAL 15 MG 1 DAILY ORAL Lithum C Date:02/25/99ISR Number: 3216082-9Report Type:Periodic Company Report #JAUSA-34842 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Health Risperdal Amenorrhoea Professional (Risperidone) PS Janssen ORAL 1.5 MG 1 Hyperprolactinaemia DAILY ORAL Risperdal (Risperidone) SS Lithium C Effexor C Klonopin C Synthroid C 22-Feb-2006 08:20 AM Page: 538 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sinemet C Neurontin C Date:02/25/99ISR Number: 3216084-2Report Type:Periodic Company Report #JAUSA-34865 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amenorrhoea Health Risperdal Initial or Prolonged Condition Aggravated Professional (Risperidone) Galactorrhoea Janssen Tablets PS Janssen ORAL 3 MG 2 MG Hyperprolactinaemia DAILY ORAL Date:02/25/99ISR Number: 3216088-XReport Type:Periodic Company Report #JAUSA-34871 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Leukopenia Professional (Risperidone) PS ORAL 8 MG DAILY Thrombocytopenia ORAL Risperdal (Risperidone) SS Date:02/25/99ISR Number: 3216093-3Report Type:Periodic Company Report #JAUSA-34878 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Risperdal Dizziness (Risperidone) PS Janssen ORAL 2 MG 1 DAILY Eructation ORAL Hypertonia Tylenol C Nausea Aspirin C Date:02/25/99ISR Number: 3216097-0Report Type:Periodic Company Report #JAUSA-34885 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspartate Health Risperdal Aminotransferase Professional (Risperidone) PS Janssen ORAL -, ORAL Increased Trazodone Neutropenia (Trazodone) SS ORAL -, ORAL Risperdal (Risperidone) SS Date:02/25/99ISR Number: 3216102-1Report Type:Periodic Company Report #JAUSA-34897 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphadenopathy Health Risperdal Professional (Risperidone) PS ORAL 8 MG DAILY ORAL Depakote C Ativan C 22-Feb-2006 08:20 AM Page: 539 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3216257-9Report Type:Periodic Company Report #JAUSA-35023 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG PRN ORAL Date:02/25/99ISR Number: 3216260-9Report Type:Periodic Company Report #JAUSA-35024 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Health Risperdal Professional (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3216265-8Report Type:Periodic Company Report #JAUSA-35027 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1.5 MG DAILY ORAL; 1MG IN THE A.M., .5 MG IN THE P.M. Allegra C Date:02/25/99ISR Number: 3216268-3Report Type:Periodic Company Report #JAUSA-35033 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Risperdal Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL; 3.5 MG 1 DAILY; 5 MG 1 DAILY; 6 MG 1 DAILY ORAL 8 WK Date:02/25/99ISR Number: 3216271-3Report Type:Periodic Company Report #JAUSA-35035 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL .5 MG 2 DAILY ORAL Imipramine C Micronase C Xanax C Verapamil C Betoptic C 22-Feb-2006 08:20 AM Page: 540 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3216279-8Report Type:Periodic Company Report #JAUSA-35036 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Consumer Risperdal (Risperidone), Janssen, Tablet 2 Mg PS Janssen ORAL .5 MG 1 DAILY ORAL Lithonate C Armour Thyroid C Date:02/25/99ISR Number: 3216283-XReport Type:Periodic Company Report #JAUSA-35037 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Pain Health Risperdal Galactorrhoea Professional (Risperidone), Sedation Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG 1 DAILY ORAL; 1 MG 1 DAILY Zoloft C Date:02/25/99ISR Number: 3216286-5Report Type:Periodic Company Report #JAUSA-35038 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Pain Health Risperdal Hypertrophy Breast Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3216290-7Report Type:Periodic Company Report #JAUSA-35039 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Increased Appetite Health Risperdal Weight Increased Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY ORAL Ritalin C Date:02/25/99ISR Number: 3216296-8Report Type:Periodic Company Report #JAUSA-35040 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Hyperprolactinaemia Professional (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3216298-1Report Type:Periodic Company Report #JAUSA-35041 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Salivary Hypersecretion Professional (Risperidone), 22-Feb-2006 08:20 AM Page: 541 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Janssen, Tablet 1 Mg PS Janssen ORAL .5 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3216303-2Report Type:Periodic Company Report #JAUSA-35042 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Professional (Risperdone), Janssen, Tablet PS ORAL 8 MG DAILY ORAL;12 MG DAILY ORAL Insulin C Date:02/25/99ISR Number: 3216305-6Report Type:Periodic Company Report #JAUSA-35043 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL .5 MG 2 DAILY ORAL; .5 MG 1 DAILY Zoloft C Potassium C Hytrin C Date:02/25/99ISR Number: 3216308-1Report Type:Periodic Company Report #JAUSA-35044 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal Professional (Risperidone), Janssen, Tablet One Week Ago PS Janssen ORAL 3 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3216310-XReport Type:Periodic Company Report #JAUSA-35045 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Consumer Risperdal (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3216312-3Report Type:Periodic Company Report #JAUSA-35047 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Initial or Prolonged Syndrome Professional (Risperidone), Janssen, Tablet PS Janssen ORAL 1 MG 1 DAILY ORAL; 2 MG 2 DAILY ORAL 14 MON 22-Feb-2006 08:20 AM Page: 542 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3216314-7Report Type:Periodic Company Report #JAUSA-35048 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Health Risperdal Hypertonia Professional (Risperidone), Psychotic Disorder Janssen, Tablet PS ORAL -, ORAL Tachycardia Haldol C Tegretol C Zoloft C Anafranil C Date:02/25/99ISR Number: 3216315-9Report Type:Periodic Company Report #JAUSA-35050 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal Decreased Professional (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 2 DAILY ORAL;2 MG 2 DAILY; 3 MG 2 DAILY 5 DAY Zoloft C Date:02/25/99ISR Number: 3216316-0Report Type:Periodic Company Report #JAUSA-35070 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Risperdal Agitation (Risperidone), Depression Janssen, Tablet PS Janssen ORAL 7 MG 2 DAILY Insomnia ORAL; 2 MG 1 Nausea DAILY; 4 MG Weight Increased DAILY;1.5 MG 2 DAILY ORAL 31 DAY Paxil (Paroxetine) Tablet 20 Mg SS ORAL 20 MG 2 DAILY ORAL Buspar C Synthroid C Date:02/25/99ISR Number: 3216319-6Report Type:Periodic Company Report #JAUSA-35073 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Consumer Risperdal (Risperidone), Janssen, Tablet 1 Mg PS Janssen ORAL .5 MG 2 DAILY ORAL Lanoxin C Atenolol C Lasix C 22-Feb-2006 08:20 AM Page: 543 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3216327-5Report Type:Periodic Company Report #JAUSA-34777 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Leukopenia Professional (Risperidone) PS Janssen ORAL 1 MG 1 DAILY Muscle Contractions ORAL Involuntary Thorazine Neuroleptic Malignant (Chlorpromazine) SS ORAL ORAL Syndrome Luvox (Fluvoxamine) SS Urinary Incontinence Effexor C Lithium C Date:02/25/99ISR Number: 3216329-9Report Type:Periodic Company Report #JAUSA-34778 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Risperdal Agitation Professional (Risperidone) PS Janssen ORAL 5 MG DAILY Condition Aggravated ORAL Droperidol C Chlorpromazine C Trazodone C Date:02/25/99ISR Number: 3216335-4Report Type:Periodic Company Report #JAUSA-34779 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pollakiuria Health Risperdal Professional (Risperidone) PS Janssen ORAL 2 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3216339-1Report Type:Periodic Company Report #JAUSA-34782 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Atrophic Vulvovaginitis (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Depakote C Trazadone C Date:02/25/99ISR Number: 3216343-3Report Type:Periodic Company Report #JAUSA-34784 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Consumer Risperdal (Risperidone) PS Janssen ORAL 6 MG 1 DAILY ORAL Dextroamphetamine C Date:02/25/99ISR Number: 3216345-7Report Type:Periodic Company Report #JAUSA-34785 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polyuria Health Risperdal Thirst Professional (Risperidone) PS Janssen ORAL 2 MG 1 DAILY 22-Feb-2006 08:20 AM Page: 544 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Depakote C Date:02/25/99ISR Number: 3216347-0Report Type:Periodic Company Report #JAUSA-34786 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Disturbance Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL Prozac C Xanax C Date:02/25/99ISR Number: 3216348-2Report Type:Periodic Company Report #JAUSA-34787 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Health Risperdal Professional (Risperidone) PS Janssen ORAL DAILY, ORAL Prozac C Klonopin C Atenolol C Trazodone C Date:02/25/99ISR Number: 3216350-0Report Type:Periodic Company Report #JAUSA-34788 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Health Risperdal Salivary Hypersecretion Professional (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL; .25 MG DAILY ORAL Date:02/25/99ISR Number: 3216353-6Report Type:Periodic Company Report #JAUSA-34789 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Health Risperdal Salivary Hypersecretion Professional (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL Date:02/25/99ISR Number: 3216355-XReport Type:Periodic Company Report #JAUSA-34790 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Consumer Risperdal (Risperidone) PS Janssen ORAL ORAL Date:02/25/99ISR Number: 3216357-3Report Type:Periodic Company Report #JAUSA-34791 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Health Risperdal Salivary Hypersecretion Professional (Risperidone) PS Janssen ORAL 1 MG 1 DAILY ORAL 22-Feb-2006 08:20 AM Page: 545 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/99ISR Number: 3216359-7Report Type:Periodic Company Report #JAUSA-34793 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal Fatigue (Risperidone) PS Janssen ORAL 1 MG 1 DAILY Hyperhidrosis ORAL Pain In Extremity Luvox C Date:02/25/99ISR Number: 3216369-XReport Type:Periodic Company Report #JAUSA-34794 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Risperdal Galactorrhoea Professional (Risperidone) PS Janssen ORAL 2 MG 2 DAILY Hyperprolactinaemia ORAL Lithium C Date:02/25/99ISR Number: 3216372-XReport Type:Periodic Company Report #JAUSA-34795 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Abnormal Health Risperdal Professional (Risperidone) PS Janssen ORAL 1 MG 2 DAILY ORAL Sulfasalazine C Atarax C Date:02/25/99ISR Number: 3216375-5Report Type:Periodic Company Report #JAUSA-34796 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Osteoporosis Health Risperdal Professional (Risperidone) PS Janssen ORAL .5 MG 2 DAILY ORAL; 1 MG 2 DAILY ORAL Date:02/25/99ISR Number: 3216379-2Report Type:Periodic Company Report #JAUSA-34797 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Consumer Risperdal Blepharitis (Risperidone) PS Janssen ORAL .5 MG 2 DAILY Convulsion ORAL; 1 MG 2 Cough DAILY ORAL 17 DAY Cystitis Synthroid C Dermatitis Zinc C Flushing Imdur C Nightmare Xanax C Date:02/25/99ISR Number: 3216383-4Report Type:Periodic Company Report #JAUSA-34798 Age:58 YR Gender:Male I/FU:I Outcome PT Other Agitation Apathy Asthenia 22-Feb-2006 08:20 AM Page: 546 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Extrapyramidal Disorder Hypokalaemia Orthostatic Hypotension Report Source Product Role Manufacturer Route Dose Duration Tremor Health Risperdal Professional (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Lithium C Date:02/25/99ISR Number: 3216386-XReport Type:Periodic Company Report #JAUSA-34799 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Erectile Dysfunction Professional (Risperidone) PS Janssen ORAL 3 MG 2 DAILY ORAL Serzone C Zyprexa C Prozac C Paxil C Symmetrel C Cotensin C Diazide C Date:02/25/99ISR Number: 3216389-5Report Type:Periodic Company Report #JAUSA-34801 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Therapeutic Response Health Risperdal Decreased Professional (Risperidone) PS Janssen ORAL 1 MG;2 MG; 3 MG 2 DAILY ORAL 4 DAY Zoloft C Date:02/25/99ISR Number: 3216708-XReport Type:Periodic Company Report #9809463 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Zoloft Tablets PS ORAL ORAL Professional Risperdal SS ORAL ORAL Company Representative Date:02/25/99ISR Number: 3417220-5Report Type:Periodic Company Report #JAUSA-34277 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Attention Consumer Risperdal Deficit/Hyperactivity (Risperidone), Disorder Janssen, Tablet 3 Mg PS Janssen ORAL 1.5 MG 2 Insomnia DAILY ORAL - SEE IMAGE Navane (Tiotixene) C Thorazine (Chlorpromazine) C Loestrin (Loestrin (R)) C Benadryl 22-Feb-2006 08:20 AM Page: 547 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Diphenhydramine) C Date:02/26/99ISR Number: 3208445-2Report Type:Expedited (15-DaCompany Report #10717-AR Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Systemic Lupus Foreign Orap (Pimozide Erythematosus Health Tablets Usp) PS ORAL ORAL Thrombosis Professional Risperidone Tablets SS Other Haloperidol SS Date:02/26/99ISR Number: 3208519-6Report Type:Expedited (15-DaCompany Report #JAUSA-36293 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Health Risperdal Initial or Prolonged Blood Creatine Professional (Risperisone), Phosphokinase Increased Janssen, Tablet 3 Mg PS Janssen 3 MG 2 DAILY Confusional State ORAL Hallucination Prozac (Fluoxetine) C Hypotonia Depakote (Valproate Myoglobin Urine Sodium) C Rhabdomyolysis Date:02/26/99ISR Number: 3213477-4Report Type:Periodic Company Report #8-98225-084A Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Effexor PS ORAL 75 MG DAILY Galactorrhoea ORAL; 150 MG Headache DAILY; 300 MG Hormone Level Abnormal DAILY 3 MON Risperdal (Risperidone) Tablets SS ORAL ORAL Tri-Leven (Ethinyl Estradiol / Levonorgestrel) Tablets C Date:02/26/99ISR Number: 3214390-9Report Type:Periodic Company Report #8-98279-036A Age:34 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Overdose Literature Venlafaxine Hydrochloride PS ORAL ORAL Acetaminophen/Propox yphene SS ORAL ORAL Risperidone SS ORAL ORAL Date:02/26/99ISR Number: 3214491-5Report Type:Periodic Company Report #8-98141-020A Age: Gender:Male I/FU:I Outcome PT Report Source Other Erectile Dysfunction Health Professional Company 22-Feb-2006 08:20 AM Page: 548 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Effexor PS ORAL ORAL Risperdal (Risperidone) Tablets SS ORAL 3MG TWICE DAILY ORAL Date:02/26/99ISR Number: 3215547-3Report Type:Periodic Company Report #8-98062-030D Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Effexor PS 75 MG TWICE Professional DAILY Company Quinine Sulfate SS 1 AT BEDTIME Representative Risperdal (Risperidone) SS 1 MG AT BEDTIME Glucophage C Trental C Date:02/26/99ISR Number: 3217017-5Report Type:Periodic Company Report #8-98345-071A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thirst Health Effexor PS ORAL ORAL Weight Increased Professional Eskalith (Lithium) Tablets SS ORAL 450 MG THREE TIMES DAILY ORAL Paxil (Paroxetine) SS ORAL 20 MG TWICE DAILY ORAL Risperdal (Risperidone) Tablets SS ORAL 2 MG TWICE DAILY ORAL Date:02/26/99ISR Number: 3408310-1Report Type:Periodic Company Report #001-0073-980355 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Dilantin Suspension Drug Level Changed Professional 125 Mg/5 Ml (Phenytoin Sodium) PS Lamotrigine SS Neurontin(Gabapentin ) SS Carbamazepine SS Declomycin(Demeclocy cline Hydrochloride) SS Risperdal(Risperidon e) SS Ativan (Lorazepam) SS Jevity (Potassium Bicarbonate, Potassium Bitartrate, Soya 22-Feb-2006 08:20 AM Page: 549 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oil, Corn Oil, SS PER TUBE Vagal Nerve Stimulator SS Date:02/26/99ISR Number: 3417057-7Report Type:Periodic Company Report #001-0945-980233 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Bilirubin Increased Consumer Neurontin Capsules Depression 100 Mg (Gabapentin) PS ORAL 300 MG (100 Drug Interaction MG, TID), PER Gallbladder Disorder ORAL Sedation Risperdal (Risperidone) SS Paxil (Paroxetine Hydrochloride) C Klonopin (Clonazepam) C Date:03/05/99ISR Number: 3214418-6Report Type:Expedited (15-DaCompany Report #JAUSA-43407 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arthralgia Foreign Risperidone Asthenia Study (Risperidone), Atrial Fibrillation Health Janssen, Solution PS ORAL .25 ML 2 Cardiac Failure Professional DAILY ORAL Congestive Imdur C Cardiomegaly Ural C Cerebrovascular Accident Digoxin C Crepitations Lanoxin C Facial Palsy Neo-Cytamen C Hypertension Infarction Loss Of Consciousness Pulmonary Oedema Tachycardia Tachypnoea Date:03/05/99ISR Number: 3214552-0Report Type:Expedited (15-DaCompany Report #JAFIN-43416 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Risperdal PS ORAL 8 MG DAILY Initial or Prolonged Neutropenia ORAL Zyprexa (Olanzapine) Tablet SS ORAL 5 MG DAILY ORAL Risperdal (Risperidone) SS ORAL 5 MG DAILY ORAL 4 DAY Zyprexa (Olanzapine) SS ORAL 10 MG DAILY ORAL Diapam (Diazepam) C 22-Feb-2006 08:20 AM Page: 550 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/99ISR Number: 3214557-XReport Type:Expedited (15-DaCompany Report #JAKYO-42895 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Risperidone PS ORAL 9 MG DAILY Hospitalization - Phosphokinase Increased Health ORAL (SEE Initial or Prolonged Chromaturia Professional IMAGE) Constipation Levomepromazine Difficulty In Walking Maleate Fall (Levomepromazine) Gastritis Granules SS ORAL 30 MG DAILY Haematuria ORAL Liver Function Test Flunitrazepam Abnormal (Flunitrazepam) C Myoglobinuria Amobarbital Nuclear Magnetic (Amobarbital) C Resonance Imaging Promethazine Abnormal Hydrochloride Pain In Extremity (Promethazine) C Restlessness ... C ORAL 6 MG DAILY Rhabdomyolysis ORAL, 4.5 MG Sleep Disorder DAILY 14 WK Urinary Incontinence Bromazepam (Bromazepam) C Sennoside (Sennosides) C Biperiden Hydrochloride (Cetraxate) C Date:03/05/99ISR Number: 3214563-5Report Type:Expedited (15-DaCompany Report #JAKYO-43326 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperidone Tablet PS Janssen ORAL 4 MG DAILY Initial or Prolonged Phosphokinase Increased Health ORAL (SEE Blood Urea Increased Professional IMAGE) Fall Levomepromazine Hepatic Enzyme Increased Maleate (Levomepromazine) C ... C ORAL 6 MG DAILY ORAL 29 DAY Sennosides (Sennosides) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:03/08/99ISR Number: 3214964-5Report Type:Expedited (15-DaCompany Report #JAUSA-36334 Age:78 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Culture Positive Initial or Prolonged Catatonia Coma Gastrointestinal Haemorrhage Haemoglobin Decreased Hyperhidrosis 22-Feb-2006 08:20 AM Page: 551 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Rigidity Occult Blood Positive Oral Intake Reduced Report Source Product Role Manufacturer Route Dose Duration Pneumonia Health Risperdal Pyrexia Professional (Risperidone), Sepsis Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 2 DAILY Staphylococcal Infection ORAL Weight Decreased Date:03/08/99ISR Number: 3214965-7Report Type:Expedited (15-DaCompany Report #JAUSA-36247 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Idiopathic Professional (Risperidone), Thrombocytopenic Purpura Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 2 DAILY Increased Tendency To ORAL 2 MG 2 Bruise DAILY Medication Error Haldol Platelet Count Decreased (Haloperidol), Psychotic Disorder Janssen, Tablet SS Janssen ORAL 5 MG 1 DAILY Red Blood Cell Count ORAL Decreased Lithium (Lithium) SS ORAL 300 MG 3 White Blood Cell Count DAILY ORAL 8 DAY Increased Depakote (Valproate Sodium) SS ORAL 1250 MG DAILY ORAL 500 MG AT 8 AM AND 8 PM, 250 MG AT 12 N 8 DAY Nifedipine C Klonopin C Prednisone C Date:03/08/99ISR Number: 3215026-3Report Type:Expedited (15-DaCompany Report #JAKYO-42895 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Risperidone Hospitalization - Increased Health (Risperidone), Initial or Prolonged Aspartate Professional Janssen, Granules PS Janssen ORAL 9 MG DAILY Aminotransferase ORAL/6 MG Increased DAILY/4.5 MG Blood Creatine DAILY 14 WK Phosphokinase Increased Levomepromazine Blood Lactate Maleate Dehydrogenase Increased (Levomepromazine) Constipation Granules SS ORAL 30 MG DAILY Difficulty In Walking ORAL Enzyme Abnormality Flunitrazepam C Gastritis Amobarbital C Haematuria Promethazine Haemoglobinaemia Hydrochloride C Myoglobinuria Bromazepam C Pain In Extremity Sennoside C Restlessness Biperiden Rhabdomyolysis Hydrochloride C Sleep Disorder Cetraxate Urinary Incontinence Hydrochloride C 22-Feb-2006 08:20 AM Page: 552 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/10/99ISR Number: 3218236-4Report Type:Direct Company Report # Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dermatitis Bullous Health Risperidone 3 Mg Bid PS ORAL 3 MG BID PO 4 DAY Hospitalization - Dermatitis Exfoliative Professional Initial or Prolonged Hypotension Required Mental Impairment Intervention to Mouth Ulceration Prevent Permanent Oliguria Impairment/Damage Shock Stevens-Johnson Syndrome Tachycardia Date:03/11/99ISR Number: 3218265-0Report Type:Expedited (15-DaCompany Report #980311-107051438 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Chloride Increased Health Levaquin Life-Threatening Blood Urea Increased Professional (Levofloxacin) Other Coma Tablets PS ORAL 500 MG QID Hyperkalaemia ORAL-500 MG Lethargy ONCE ORAL Lung Infiltration Risperidone SS ORAL .5 MG QD Medication Error ORAL, .5 BID Overdose ORAL, .5 MG Pco2 Decreased ONCE ORAL Pneumonia Aspiration Ibuprofen C Pulmonary Congestion Megesterol Acetate C Respiratory Arrest Respiratory Distress Date:03/12/99ISR Number: 3219229-3Report Type:Expedited (15-DaCompany Report #JAUSA-36476 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Risperdal PS ORAL 1 MG 1 DAILY Initial or Prolonged Prolonged Professional ORAL Pneumonia Remeron C Urinary Tract Infection Wellbutrin C Date:03/12/99ISR Number: 3219266-9Report Type:Expedited (15-DaCompany Report #JAUSA-36513 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemorrhage Health Risperdal PS ORAL 3 MG 2 DAILY Initial or Prolonged Idiopathic Professional ORAL Thrombocytopenic Purpura Risperdal Thrombocytopenia (Risperidone) SS Vaginal Haemorrhage Date:03/12/99ISR Number: 3219269-4Report Type:Expedited (15-DaCompany Report #JAUSA-36512 Age:65 YR Gender:Male I/FU:I Outcome PT Hospitalization - Asthenia Initial or Prolonged Dehydration Fall 22-Feb-2006 08:20 AM Page: 553 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Flat Affect Parkinson'S Disease Pyrexia Report Source Product Role Manufacturer Route Dose Duration Respiratory Distress Health Risperdal PS Janssen ORAL -, ORAL Professional Risperdal (Risperidone) SS Date:03/15/99ISR Number: 3221134-3Report Type:Expedited (15-DaCompany Report #JAUSA-36522 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:03/15/99ISR Number: 3221511-0Report Type:Expedited (15-DaCompany Report #JASWE-43555 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytoclastic Foreign Risperdal PS Janssen ORAL 0.5 MG DAILY Initial or Prolonged Vasculitis ORAL Pruritus Optimol (Timolol) C Rash Erythematous Timpilo Forte (Timpilo(R)) C Zantac (Ranitidine) C Trusopt (Dorzolamide) C Date:03/15/99ISR Number: 3221566-3Report Type:Expedited (15-DaCompany Report #JAKYO-42779 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Risperidone PS Janssen ORAL 11 MG DAILY Bronchitis Health ORAL Nasopharyngitis Professional Nitrazepam C Trihexiphenidyl Hydrochloride C Amezinii Metylsulfate C Nitrazepam C Mosapramine C Clarithromycin C Magnesium Oxide C Date:03/15/99ISR Number: 3221640-1Report Type:Expedited (15-DaCompany Report #9909495 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Complications Of Maternal Health Zoloft PS ORAL 50.00 MG Intervention to Exposure To Therapeutic Professional TOTAL:DAILY; Prevent Permanent Drugs TAB Impairment/Damage Drug Withdrawal Syndrome Risperdal SS INTRA-UTERINE 1.00 MG Neonatal TOTAL:DAILY:I Feeding Disorder Neonatal NTRAUTERINE Feeling Jittery Hyperreflexia Irritability 22-Feb-2006 08:20 AM Page: 554 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/99ISR Number: 3220194-3Report Type:Expedited (15-DaCompany Report #JACAN-16858 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Risperidone Heat Exhaustion Consumer (Risperidone) PS Janssen ORAL 4 MG 2 DAILY Heat Stroke ORAL Pyrexia Ranitidine (Ranitidine)- SS ORAL 150 MG 1 DAILY ORAL Benztropine C Clonazepam C Date:03/17/99ISR Number: 3222151-XReport Type:Expedited (15-DaCompany Report #9909177 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Literature Zoloft PS ORAL TABLET, 50.00 Initial or Prolonged Automatism Health MG Catatonia Professional TOTAL:DAILY:O Condition Aggravated RAL Depression Valproic Acid SS ORAL 500.00 MG Disorientation TOTAL:BID:ORA Dizziness L Drug Interaction Risperidone SS ORAL 8.00 MG Flat Affect TOTAL:ORAL Hallucination, Auditory Hypomania Immobile Mutism Negativism Social Avoidant Behaviour Somatic Delusion Staring Suicidal Ideation Thinking Abnormal Thought Blocking Tremor Date:03/18/99ISR Number: 3222397-0Report Type:Direct Company Report # Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Risperidone PS ORAL 1MG PO QD Hospitalization - Phosphokinase Increased Initial or Prolonged Circulatory Collapse Required Hypertension Intervention to Neuroleptic Malignant Prevent Permanent Syndrome Impairment/Damage Pyrexia Tachycardia Date:03/18/99ISR Number: 3223462-4Report Type:Direct Company Report # Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Risperidone PS ORAL 3 MG PO BID Initial or Prolonged Dyskinesia Olanzapine C 22-Feb-2006 08:20 AM Page: 555 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/99ISR Number: 3223465-XReport Type:Direct Company Report # Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Risperidone PS 6 MG BID Initial or Prolonged Date:03/18/99ISR Number: 3223468-5Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Breast Discharge Risperidone PS ORAL 3 MG PO BID 2 MON Intervention to Breast Pain Prevent Permanent Hyperprolactinaemia Impairment/Damage Hypertrophy Breast Date:03/19/99ISR Number: 3223451-XReport Type:Expedited (15-DaCompany Report #JAAUS-43407 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arthralgia Foreign Risperidone Atrial Fibrillation Study (Risperidone), Blood Pressure Systolic Health Janssen, Solution PS Janssen ORAL .25 MG 2 Increased Professional DAILY ORAL Blood Urea Increased Imdur C Cardiac Failure Ural C Congestive Digoxin C Cardiomegaly Lanoxin C Cerebrovascular Accident Neo-Cytamen C Crepitations Folate Sodium C Facial Palsy Hemiparesis Infarction Loss Of Consciousness Pain Pulmonary Oedema Refusal Of Treatment By Patient Tachycardia Tachypnoea Date:03/19/99ISR Number: 3223460-0Report Type:Expedited (15-DaCompany Report #JAKYO-43493 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperidone Myocardial Infarction Health (Risperidone) PS Janssen ORAL 3 MG DAILY Professional ORAL Fluphenazine Maleate C Sulpiride C Biperiden Hydrochloride C 22-Feb-2006 08:20 AM Page: 556 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/99ISR Number: 3223463-6Report Type:Expedited (15-DaCompany Report #JAKYO-43544 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Influenza Like Illness Foreign Risperidone Hospitalization - Pneumonia Health (Risperidone) PS ORAL 2 MG DAILY Initial or Prolonged Pyrexia Professional ORAL Respiratory Failure Cisapride C Carbamazepine C Oxypertine C Biperiden Hydrochloride C Marzulene-S C Levomepromazine Maleate C Date:03/19/99ISR Number: 3223715-XReport Type:Expedited (15-DaCompany Report #990315-008011096 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cachexia Foreign Haloperidol, Delirium Health Unspecified PS ORAL SEE IMAGE Eosinophilia Professional Risperidone SS ORAL SEE IMAGE Gastric Cancer Stage Iv Biperiden Hypochloraemia Hydrochloride SS ORAL 5 MG, QD, Hypokalaemia ORAL Liver Function Test Nitrazepam SS ORAL 5 MG, QD, Abnormal ORAL Lymphopenia Flunitrazepam SS ORAL 2 MG, QD, Metastases To Lung ORAL Neutrophilia Flurazepam Pneumonia Hydrchloride SS ORAL 20 MG, QD, Urobilinuria ORAL Cilastatin Soduim W/Imipenem SS INTRAVENOUS 500 MG, QD, IV (INTRAVEOUS) Piperacillin Sodium SS INTRAVENOUS 2 MG, QD, IV Desozopram Hydrochloride SS INTRAVENOUS 2 G, QD, IV (INTRAVEOUS) Oxiracetam C Cefozopran Hydrochloride C Cefotiam Hydrochloride C Clindamycin C Isepamicin Sulfate C Date:03/22/99ISR Number: 3224305-5Report Type:Expedited (15-DaCompany Report #JAKYO-43326 Age:54 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Blood Urea Increased Condition Aggravated Fall Liver Function Test Abnormal 22-Feb-2006 08:20 AM Page: 557 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Persecutory Delusion Report Source Product Role Manufacturer Route Dose Duration Foreign Risperidone Health (Risperidone) PS Janssen ORAL 4 MG DAILY Professional ORAL Risperidone (Risperidone) Tablet SS ORAL 6 MG DAILY ORAL 29 DAY Levomepromazine Maleate C Sennosides C Biperiden Hydrochloride C Date:03/22/99ISR Number: 3224308-0Report Type:Expedited (15-DaCompany Report #JAKYO-42852 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Risperidone Phosphokinase Increased Health (Risperidone) PS Janssen ORAL 2 MG DAILY Cachexia Professional ORAL Delirium Haloperidol Eosinophilia (Haloperidol) SS Janssen ORAL 2.25 MG DAILY Gastric Cancer ORAL Gastric Polyps Risperidone Gastritis Erosive (Risperidone) Tablet SS ORAL 3 MG DAILY Hypocalcaemia ORAL 9 DAY Hypochloraemia Haloperidol Hypokalaemia (Haloperidol) SS ORAL 6 MG DAILY Liver Function Test ORAL Abnormal Biperiden Lymphopenia Hydrochloride Metastases To Lung (Biperiden Neutrophilia Hydrochloride) SS ORAL 3 MG DAILY Pneumonia ORAL Urobilinuria Nitrazepam (Nitrazepam) SS ORAL 5 MG DAILY ORAL 10 MON Flunitrazepam (Flunitrazepam) SS ORAL 2 MG DAILY ORAL 6 MON Flurazepam Hydrochloride (Flurazepam) SS ORAL 20 MG DAILY ORAL 6 MON Tienam (Tienam (R) ) SS 500 MG DAILY INTRAJEJUNAL 4 DAY Piperacillin Sodium (Piperacillin) SS 2 G DAILY INTRAJEJUNAL 10 DAY Cefozopran Hydrochloride (Cefozopran) SS 2 G DAILY INTRAJEJUNAL 2 G DAILY INTRAJEJUNAL 10 DAY Aniracetam C Cefotiam 22-Feb-2006 08:20 AM Page: 558 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride C Clindamycin C Isepamicin Sulfate C Date:03/22/99ISR Number: 3224310-9Report Type:Expedited (15-DaCompany Report #JAKYO-43565 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Risperidone Erythema Annulare Health (Risperidone) Pneumonia Professional Granules PS Janssen ORAL 6 MG DAILY Pyrexia ORAL Carbamazepine (Carbamazepine)- SS ORAL 600 MG DAILY ORAL Haloperidol C Levomepromazine Maleate C Promethazine Hydrochloride C Flunitrazepam C Biperiden Hydrochloride C Sultiame C Clonazepam C Date:03/24/99ISR Number: 3224446-2Report Type:Direct Company Report # Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Body Temperature Lithium PS 300MG Q AM Intervention to Decreased 2PM LONG-TERM Prevent Permanent Confusional State Risperidone 0.5mg Impairment/Damage Drooling Bid SS +450MG QHS Exophthalmos Benztropine C Dipherhydramine C Lorazepam C Risperidone C Date:03/24/99ISR Number: 3225571-2Report Type:Direct Company Report # Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Risperdol PS ORAL 3 MG PO QHS, Initial or Prolonged Blood Creatine 1.5 MG PO Phosphokinase Increased QHS; 1.0 MG Depressed Level Of PO QHS. Consciousness Nortriptyline C Depression Xanax C Fall Aricept C Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Thermal Burn 22-Feb-2006 08:20 AM Page: 559 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/99ISR Number: 3225709-7Report Type:Expedited (15-DaCompany Report #JAKYO-43493 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperidone Myocardial Infarction Health (Risperidone), Professional Janssen, Granules PS Janssen ORAL 3 MG DAILY ORAL Fluphenazine Maleate (Fluphenazine) C Sulpiride (Sulpiride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:03/24/99ISR Number: 3225713-9Report Type:Expedited (15-DaCompany Report #JAUSA-36544 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Health Risperdal Initial or Prolonged Condition Aggravated Professional (Risperidone), Ileus Paralytic Janssen, Tablet PS Janssen ORAL 6 MG 1 DAY Psychotic Disorder ORAL Rectal Haemorrhage Remeron (Mirtazapine) C Date:03/24/99ISR Number: 3225771-1Report Type:Expedited (15-DaCompany Report #JASWZ-43625 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal (Risperidone), Janssen PS Janssen ORAL 2 MG DAILY ORAL Date:03/24/99ISR Number: 3225882-0Report Type:Direct Company Report # Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Risperdal Jannsen Tongue Disorder Pharm PS Jannsen Pharm 2MG BID Date:03/25/99ISR Number: 3225716-4Report Type:Expedited (15-DaCompany Report #JAFRA-43573 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Bullous Foreign Risperdal Initial or Prolonged Pemphigoid (Risperidone), Janssen, Tablet 1 Mg PS Jansssen ORAL .5 MG ORAL Modopar (Modopar (R)) C 22-Feb-2006 08:20 AM Page: 560 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/99ISR Number: 3226315-0Report Type:Direct Company Report # Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Risperdal PS Janssen 3MG PO BID Hospitalization - Idiopathic Artane C Initial or Prolonged Thrombocytopenic Purpura Cylert C Required Splenectomy Serax C Intervention to Thrombocytopenia Fosamax C Prevent Permanent Cromolyn C Impairment/Damage Date:03/26/99ISR Number: 3227695-2Report Type:Expedited (15-DaCompany Report #JAFRA-43617 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Oedema Foreign Risperdal Initial or Prolonged Coma Health (Risperidone) PS Janssen ORAL ORAL Inappropriate Professional Daflon (Daflon(R)) C Antidiuretic Hormone Secretion Date:03/26/99ISR Number: 3228560-7Report Type:Expedited (15-DaCompany Report #JABEL-41591 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Foreign Risperdal Initial or Prolonged Fluctuation Study (Risperidone) Cardiac Disorder Health Janssen, Tablet PS ORAL 7 MG 1 DAILY Heart Rate Irregular Professional ORAL Hypotension Risperdal Supraventricular (Risperidone) SS ORAL 6 MG 1 DAILY Extrasystoles ORAL 3 DAY Ventricular Extrasystoles Supradyn C Stilnoct C Hydergine C Date:03/29/99ISR Number: 3228768-0Report Type:Expedited (15-DaCompany Report #US_990319449 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Risperidone PS 2 DSG FORM Initial or Prolonged Asthenia Health Aricept C Dysarthria Professional Imdur C Movement Disorder Ecotrin C Transient Ischaemic Ibuprofen C Attack Lescol C Ogen C Multivitamin C Vitamin C C Folic Acid C Covera-Hs C Detrol C Benadryl C Vitamin B12 C Calcium C K-Dur C Vitamin E C 22-Feb-2006 08:20 AM Page: 561 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/99ISR Number: 3228829-6Report Type:Expedited (15-DaCompany Report #JAFRA-40439 Age:92 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Foreign Risperdal Neutropenia Health (Risperidone), Professional Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG DAILY ORAL Stilnox (Zolpidem) Tablet 10 Mg SS ORAL 5 MG 1 DAILY ORAL Oflocet (Ofloxacin) SS ORAL 200 MG 2 DAILY ORAL 7 DAY Nitriderm C Lanzor C Date:03/30/99ISR Number: 3229723-7Report Type:Direct Company Report # Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Disorientation Risperdal PS 1 MG -.05MG & Faecal Incontinence .02 1/2MG 20 DAY Hypersomnia Date:03/31/99ISR Number: 3230694-8Report Type:Direct Company Report # Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sluggishness Health Risperdal 1 Mg PS ORAL 1/2 MG, BID, Initial or Prolonged Tardive Dyskinesia Professional PO Haldol SS INTRAMUSCULAR 5 MG, X 1 DOSE, IM Asa C Kcl C Glucotrol C Lopressor C Florinef C Date:03/31/99ISR Number: 3230845-5Report Type:Expedited (15-DaCompany Report #10759-AR Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Orap (Pimozide Health Tablets Usp), 2 Mg PS Professional Orap (Pimozide Other Tablets Usp), 2 Mg SS ORAL 9 MG ORAL Risperdone SS UNKNOWN DAILY DOSE Lorazepam C Promethazine C Biperiden Hydrochloride C Mexazolam C Flunitrazepam C Lorazepam C Promethazine C 22-Feb-2006 08:20 AM Page: 562 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/99ISR Number: 3232150-XReport Type:Expedited (15-DaCompany Report #7398177 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Palpitations Health Abbott-Depakote PS Abbott ORAL 1.000 GM PO Intervention to Sinus Arrhythmia Professional QD Prevent Permanent Ventricular Extrasystoles Risperdal SS Impairment/Damage Ventricular Tachycardia Risperdal C Date:04/02/99ISR Number: 3232152-3Report Type:Expedited (15-DaCompany Report #7398151 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ecchymosis Other Depakote PS ORAL 1.250 GM QD Initial or Prolonged Idiopathic Risperdal SS ORAL 2.000 MG BID Other Thrombocytopenic Purpura Risperdal C Medication Error Haldol C Platelet Count Decreased Lithium C Red Blood Cell Count Decreased Schizophrenia White Blood Cell Count Increased Date:04/02/99ISR Number: 3232211-5Report Type:Expedited (15-DaCompany Report #JAKYO-43653 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperidone Granules PS Janssen ORAL 4-8 MG/DAY Health DAILY ORAL Professional Pimozide (Pimozide), Tablet SS Janssen ORAL 3-9 MG DAILY ORAL Lorazepam C Promethazine Hydrochloride C Mexazolam C Flunitrazepam C Biperiden Hydrochloride C Mexazolam C Promethazine C Date:04/05/99ISR Number: 3232850-1Report Type:Expedited (15-DaCompany Report #JAUSA-36775 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Catatonia Health Risperdal Hospitalization - Haematoma Professional (Risperidone) PS Janssen ORAL 2 MG 1 DAILY Initial or Prolonged Monoparesis ORAL Neuroleptic Malignant Unspecified C Syndrome ... C Pyrexia Tachycardia Tremor 22-Feb-2006 08:20 AM Page: 563 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/99ISR Number: 3233075-6Report Type:Expedited (15-DaCompany Report #US_990319449 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Risperidone PS 2 DSG FORM Initial or Prolonged Asthenia Health Aricept C Cerebrovascular Accident Professional Imdur C Dysarthria Ecotrin C Movement Disorder Ibuprofen C Lescol C Ogen C Multivitamin C Vitamin C C Folic Acid C Covera-Hs C Detrol C Benadryl C Vitamin B12 C Calcium C K-Dur C Vitamin E C Date:04/05/99ISR Number: 3233081-1Report Type:Expedited (15-DaCompany Report #9911521 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Navane Capsules PS ORAL 10.00 MG Initial or Prolonged Disturbance In Attention TOTAL:DAILY:O Drug Ineffective RAL Zoloft SS ORAL ORAL Zyprexa SS Risperdal SS Date:04/06/99ISR Number: 3233831-4Report Type:Expedited (15-DaCompany Report #7398197 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Abbott - Norvir PS Abbott ORAL PO Initial or Prolonged Extrapyramidal Disorder Professional Risperdal SS Other Heart Rate Increased Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Tachycardia Tremor Date:04/07/99ISR Number: 3234286-6Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Clozaril PS ORAL 100MG BID PO Decreased Risperidone SS ORAL 4MG AM 2MG HS White Blood Cell Count PO Decreased 22-Feb-2006 08:20 AM Page: 564 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/99ISR Number: 3234492-0Report Type:Direct Company Report # Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coma Risperidone PS ORAL 1 MG BID PO Lanoxin C Cozaar C Lasix C K Dur C Lovenox C Colace C Lopressor C Levaquin C Voltaren Xr C Tylenol C Date:04/07/99ISR Number: 3234613-XReport Type:Expedited (15-DaCompany Report #JAKYO-43204 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Marrow Depression Foreign Risperidone Haemoglobin Decreased Health (Risperidone), Metastasis Professional Janssen, Granules PS Janssen .5 MG DAILY Purpura ORAL; 2 MG Rash Maculo-Papular DAILY ORAL 25 WK White Blood Cell Count Indometacin C Increased Famotidine C Rhei-Mag C Rilmafazone Hydrochloride C Date:04/07/99ISR Number: 3234656-6Report Type:Expedited (15-DaCompany Report #990325-008011210 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Serenace Tablets Hospitalization - Health (Haloperidol) PS ORAL 1 MG, QD, Initial or Prolonged Professional ORAL Risperidone SS ORAL 1 MG, QD, ORAL Chlorprothixene Hydrochloride SS ORAL 30 MG, QD, ORAL Metoprolol Succinate C Amlodipine Besilate C Propranolol Hydrochloride C Calcium Carbonate C Citalopram C Epoetin Alfa C Beko Forte C Ascorbic Acid C Date:04/07/99ISR Number: 3234785-7Report Type:Expedited (15-DaCompany Report #JAUK-43858 Age:45 YR Gender:Male I/FU:I Outcome Death Hospitalization - 22-Feb-2006 08:20 AM Page: 565 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Death Foreign Risperidone Health (Risperidone) PS ORAL ORAL Professional Verapamil (Verapamil) SS Risperidone (Risperidone) C Date:04/07/99ISR Number: 3234786-9Report Type:Expedited (15-DaCompany Report #JAGER-43791 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypersensitivity Foreign Risperdal Lethargy Health (Risperidone) PS ORAL ORAL Pulmonary Embolism Professional Remergil Thrombosis (Mirtazapine) C Date:04/08/99ISR Number: 3235124-8Report Type:Expedited (15-DaCompany Report #8-99090-008A Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Stangyl Initial or Prolonged Tardive Dyskinesia Health (Trimipramine Other Professional Maleate) PS ORAL 50 MG ONCE DAILY ORAL Biperiden Hydrochloride SS 4 MG DAILY Risperidone SS 6 MG DAILY Date:04/09/99ISR Number: 3236558-8Report Type:Expedited (15-DaCompany Report #JAGER-43823 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anhedonia Foreign Risperdal Hospitalization - Dizziness Health (Risperidone) PS Janssen ORAL 7 MG DAILY Initial or Prolonged Fall Professional ORAL Lethargy Risperdal Memory Impairment (Risperidone) SS ORAL 6 MG DAILY Radius Fracture Risperdal Sedation (Risperidone) SS ORAL 8 MG DAILY Leponex (Clozapine) SS 300 MG DAILY Leponex (Clozapine) SS 275 MG DAILY 4 DAY Leponex (Clozapine) SS 250 MG DAILY Aponal (Doxepin) SS 150 MG DAILY 29 MON Aponal (Doxepin) SS 75 MG DAILY Fevarin (Fluvoxamin) SS ORAL 50 MG DAILY Date:04/12/99ISR Number: 3238089-8Report Type:Expedited (15-DaCompany Report #JASWE-43623 Age:82 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Glucose Decreased Initial or Prolonged Cardiac Failure Confusional State Epilepsy 22-Feb-2006 08:20 AM Page: 566 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypokalaemia Hypothermia Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal (Risperidone), Janssen, Solution 1 Mg/Ml PS ORAL 3 MG DAILY ORAL Folacin (Folic Acid) C Propavol (Propiomazine) C Kalium Retard (Potassium Chloride) C Sparkal (Sparkal(R)) C Date:04/12/99ISR Number: 3238098-9Report Type:Expedited (15-DaCompany Report #JAKYO-43931 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thermal Burn Foreign Risperidone Initial or Prolonged Health (Risperidone),Jansse Professional n, Tablet PS Janssen ORAL 2 MG DAILY ORAL; 4 MG DAILY ORAL Promethazine Hydrochloride (Promethazine) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Bromazepam (Bromazepam) C Levomepromazine Hamleate (Levomepromazine) C Pentobarbital Calcium (Pentobarbital) C Magnesium Oxide (Magnesium Oxide) C Pantethine (Pantethine) C Carbamazepine (Carbamazepine) C Zotepine (Zotepine) C Timiperone (Timiperone) C Date:04/12/99ISR Number: 3238099-0Report Type:Expedited (15-DaCompany Report #JAKYO-43653 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperidone Health (Risperidone),Jansse Professional n, Granules PS Janssen ORAL 4 MG DAILY ORAL; 6 MG DAILY ORAL; 8 MG DAILY ORAL 11 MON 22-Feb-2006 08:20 AM Page: 567 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pimozide (Pimozide),Janssen, Tablet SS Janssen ORAL DAILY ORAL; 9 MG DAILY Flunitrazepam (Flunitrazepam) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Mexazolam (Mexazolam) C Lorazepam (Lorazepam) C Promethazine (Promethazine) C Date:04/12/99ISR Number: 3238100-4Report Type:Expedited (15-DaCompany Report #JAKYO-43204 Age:92 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Systolic Foreign Risperidone Decreased Health (Risperidone),Jansse Condition Aggravated Professional n, Tablet PS Janssen ORAL 2 MG DAILY Delirium ORAL Disseminated Indometacin Intravascular Coagulation (Indomethacin) - SS ORAL 50 MG DAILY Haemoglobin Decreased ORAL Metastases To Lymph Nodes Famotidine Metastatic Neoplasm (Famotidine) SS ORAL 40 MG DAILY Myelodysplastic Syndrome ORAL Purpura Rilmazafone Sedation Hydrochloride Skin Discolouration (Rilmazafone) SS 2 MG DAILY White Blood Cell Count Rhei-Mag (Rhubarb Increased Powder) C Estazolam (Estazolam) C Cetilo (Cetilo(R)) C Date:04/12/99ISR Number: 3238101-6Report Type:Expedited (15-DaCompany Report #JAAUS-43906 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal Viral Myocarditis Health (Risperidone),Jansse Professional n, Tablet PS Janssen ORAL 2 MG 1 DAILY ORAL Diazepam (Diazepam) C Date:04/12/99ISR Number: 3238102-8Report Type:Expedited (15-DaCompany Report #JAUSA-36958 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Consumer Risperdal Life-Threatening Myocardial Infarction (Risperidone),Jansse n, Tablet 1 Mg PS Janssen ORAL 2 MG DAILY ORAL 22-Feb-2006 08:20 AM Page: 568 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glyburide (Glibenclamide) C Vitamine E (Vitamin E) C Zestril (Lisinopril) C Date:04/12/99ISR Number: 3238172-7Report Type:Expedited (15-DaCompany Report #A001-002-003088 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Aricept (Donepezil) PS ORAL 5 MG (1 IN 1 Initial or Prolonged Dehydration Professional D) Drug Interaction Risperdal Immobile (Risperidone) SS ORAL 0.5 MG Influenza Like Illness Cardizem (Diltiazem Muscular Weakness Hydrochloride) C Tremor Asa 9acetylsalicylic Acid) C Vitamins C Date:04/12/99ISR Number: 3238497-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Muscle Rigidity Health Risperidone PS ORAL 2MG PO Q HS 3 WK Intervention to Priapism Professional Stelazine C Prevent Permanent Vit E C Impairment/Damage Artane C Ativan C Date:04/15/99ISR Number: 3240550-7Report Type:Expedited (15-DaCompany Report #JAUSA-36976 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Consumer Risperdal Initial or Prolonged Condition Aggravated (Risperidone), Difficulty In Walking Janssen, Tablet 1 Mg PS Janssen ORAL 1 MG 1 DAILY Fall ORAL 2 MG Hip Fracture Clonidine C Muscle Rigidity Valium C Tourette'S Disorder Date:04/15/99ISR Number: 3240553-2Report Type:Expedited (15-DaCompany Report #JAUSA-35074 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Risperdal Myelodysplastic Syndrome Professional (Risperidone), Pancytopenia Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG DAILY ORAL 1 MG IN AM, 2 MG AT BEDTIME. 22-Feb-2006 08:20 AM Page: 569 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/99ISR Number: 3240556-8Report Type:Expedited (15-DaCompany Report #JAUSA-36992 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lymphadenopathy Consumer Risperdal Initial or Prolonged Platelet Count Decreased (Risperidone), Janssen, Tablet 3 Mg PS Janssen ORAL 3 MG 2 DAILY ORAL Depakote C Buspar C Amaryl C Date:04/15/99ISR Number: 3240672-0Report Type:Expedited (15-DaCompany Report #JAUK-43909 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Abortion Induced Foreign Risperidone Complications Of Maternal Health (Risperidone), Exposure To Therapeutic Professional Janssen, Tablet PS ORAL 3 MG Drugs Procyclidine Congenital Spinal Cord (Procyclidine) C Anomaly Procyclidine Meningomyelocele (Procyclidine) C Multiple Congenital Abnormalities Date:04/15/99ISR Number: 3240673-2Report Type:Expedited (15-DaCompany Report #JAGER-43791 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Hypersensitivity Foreign Risperdal Pulmonary Embolism Health (Risperidone) PS ORAL Thrombosis Professional Depression C Date:04/16/99ISR Number: 3241008-1Report Type:Direct Company Report # Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aphasia Health Risperdal PS ORAL 1 MG PO QHS 1 DAY Joint Stiffness Professional Zoloft C Ambien C Tylenol C Date:04/16/99ISR Number: 3241015-9Report Type:Direct Company Report # Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Health Risperdal PS ORAL 2 MG PO BID 6 DAY Professional Cogentin C Date:04/16/99ISR Number: 3241537-0Report Type:Expedited (15-DaCompany Report #D/97/02896/LEX Age:57 YR Gender:Female I/FU:F Outcome Death Life-Threatening Required 22-Feb-2006 08:20 AM Page: 570 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Aspiration Foreign Leponex (Clozapine) PS ORAL 250 MG ORAL Coronary Artery Disease Study Risperdal SS 6 MG Dizziness Health Aponal SS 75MG Dysphagia Professional Xanef C Embolism Isoket Retard C Fall Ximovan C Pulmonary Embolism Fevarin C Radius Fracture Ass C Respiratory Arrest Bella Isodonnys C Respiratory Depression Heparin C Tremor Vertigo Date:04/19/99ISR Number: 3242370-6Report Type:Expedited (15-DaCompany Report #JAUSA-37117 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Exposure To Extreme Consumer Risperdal Life-Threatening Temperature (Risperidone), Hypothermia Janssen, Tablet 3 Mg PS Janssen ORAL 9 MG 1 DAILY ORAL Propranolol C Clonazepam C Date:04/19/99ISR Number: 3242371-8Report Type:Expedited (15-DaCompany Report #JRFBEL1999000048 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Risperdal Initial or Prolonged Bradykinesia Health (Unspecified) Chills Professional (Risperidone) PS LONG PERIOD Drug Interaction Fluctine (Fluoxetine Masked Facies Hydrochloride) SS LONG PERIOD Parkinsonism Tardyferon C Tremor Temesta C Tranxilium C Date:04/19/99ISR Number: 3242372-XReport Type:Expedited (15-DaCompany Report #JRFBEL1999000044 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Foreign Risperidone Required Blood Creatine Health (Unspecified) Intervention to Phosphokinase Increased Professional (Risperidone) PS ORAL 3 MG, DAILY, Prevent Permanent Hallucination ORAL Impairment/Damage Hyperhidrosis Nemonapride Muscle Rigidity (Nemonapride) SS ORAL 5 MG, DAILY, Neuroleptic Malignant ORAL / 15 MG, Syndrome DAILY, ORAL / Oral Intake Reduced 10 MG, DAILY, Persecutory Delusion ORAL Pyrexia Biperiden C Etilefrine C Levomepromazine Maleate C 22-Feb-2006 08:20 AM Page: 571 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/19/99ISR Number: 3242373-1Report Type:Expedited (15-DaCompany Report #JAKYO43056 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Risperidone Hospitalization - Drowning Health (Unspecified) Initial or Prolonged Professional (Risperidone) PS ORAL DAILY, ORAL / 6 MG, DAILY, ORAL Chlorpromazine C Biperiden Hydrochloride C Date:04/19/99ISR Number: 3242921-1Report Type:Expedited (15-DaCompany Report #990416-008011435 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizoaffective Disorder Health Haloperidol Initial or Prolonged Schizophrenia Professional Decanoate PS INTRAMUSCULAR 100 MG, 1X/MO, IM (INTRAMUSCULA R) Risperidone SS ORAL 4 MG, QD, ORAL Carbamazepine C Benzotropine C Fluoxetine C Date:04/22/99ISR Number: 3244691-XReport Type:Direct Company Report # Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complex Partial Seizures Risperdal (Risperidone) PS Janssen ORAL ORAL 14MG 1/2AM & 1T HS Imipramine SS 50MG 1T BID Addreall C Tenex C Date:04/26/99ISR Number: 3247057-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999000058 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arteritis Foreign Risperdal PS ORAL ORAL 1 YR Initial or Prolonged Eosinophil Count Health Increased Professional Eyelid Oedema Hypersensitivity Pruritus Skin Injury Skin Lesion Skin Ulcer 22-Feb-2006 08:20 AM Page: 572 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/99ISR Number: 3247165-5Report Type:Expedited (15-DaCompany Report #JAUSA-36599 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bladder Cancer Consumer Risperdal Parkinson'S Disease (Risperidone), Prostate Cancer Janssen, Tablet 2 Mg PS ORAL 2 MG 1 DAILY ORAL AT BEDTIME Lisinopril C Multivitamins C Date:04/26/99ISR Number: 3250373-0Report Type:Periodic Company Report #JAUSA-35556 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Consumer Risperdal Nausea (Risperidone), Sedation Janssen, Solution 1 Visual Disturbance Mg/Ml PS ORAL SEE IMAGE 5 DAY Paxil C Date:04/26/99ISR Number: 3250376-6Report Type:Periodic Company Report #JAUSA-35686 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Risperdal Agitation Professional (Risperidone), Dizziness Janssen, Solution 1mg/Ml PS Janssen ORAL .5 MG 1 DAILY ORAL Date:04/26/99ISR Number: 3250382-1Report Type:Periodic Company Report #JAUSA-35778 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Conjunctivitis Health Risperdal Drug Abuser Professional (Risperidone), Janssen, Solution PS -, SINGLE INTRAOCULAR Date:04/26/99ISR Number: 3250384-5Report Type:Periodic Company Report #JAUSA-35865 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Health Risperdal Professional (Risperidone), Janssen, Solution 1.5 Mg PS Janssen ORAL 1.5 MG DAILY ORAL/.25 MG 2 DAILY ORAL SOLUTION 1MG/GL 6 DAY 22-Feb-2006 08:20 AM Page: 573 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/99ISR Number: 3250387-0Report Type:Periodic Company Report #JAUSA-36047 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Health Risperdal Dyspnoea Professional (Risperidone), Dystonia Janssen, Solution 1 Mg/Ml PS Janssen ORAL 3 MG 2 SINGLE ORAL/ONE DOSE GIVEN AT 9 P.M. 28-JAN-99, Date:04/26/99ISR Number: 3250392-4Report Type:Periodic Company Report #JAUSA-36518 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal Initial or Prolonged Dysphagia Professional (Risperidone), Pneumonia Janssen, Solution 1 Sedation Mg/Ml PS Janssen ORAL .25 MG PRN ORAL/EVERY EIGHT HOURS Ambien C Atenol C Prilosec C Norvasc C Dilantin C Aricept C Date:04/26/99ISR Number: 3250396-1Report Type:Periodic Company Report #JAUSA-36579 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Consumer Risperdal Involuntary (Risperidone), Janssen, Solution 1 Mg/Ml PS Janssen ORAL 1.5 MG DAILY ORAL/0.5 MG IN AM, 1 MG IN PM. Cardiazem C Prednisone C Cardura C Date:04/26/99ISR Number: 3250399-7Report Type:Periodic Company Report #JAUSA-36584 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Attention (Risperidone), Deficit/Hyperactivity Janssen, Solution 1 Disorder Mg/Ml PS Janssen ORAL 1 MG 2 DAILY ORAL/ESTIMATE D START DATE 22-Feb-2006 08:20 AM Page: 574 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/99ISR Number: 3250401-2Report Type:Periodic Company Report #JAUSA-36671 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Contractions Consumer Risperdal Involuntary (Risperidone), Janssen, Solution 1 Mg/Ml PS Janssen ORAL .5 MG 1 DAILY ORAL/ESTIMATE D START DATE./5 MG 2 DAILY ORAL 25 DAY Date:04/26/99ISR Number: 3250405-XReport Type:Periodic Company Report #JAUSA-34112 Age:5 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Risperdal Chest Pain Professional (Risperidone), Dyskinesia Janssen, Solution PS Janssen ORAL .5 MG 2 DAILY Nausea ORAL Sedation Prozac (Fluoxetine) Solution SS ORAL 5 MG 1 DAILY ORAL/USED BEFORE CONVERSION TO RISPERDAL 2 WK Date:04/27/99ISR Number: 3247442-8Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Risperidone PS ORAL 1MG PO QD 2 YR Hospitalization - Phosphokinase Increased Insulin C Initial or Prolonged Coma Lithium C Confusional State Famotidine C Depressed Level Of Troglitazone C Consciousness Buproprim C Dysarthria Hyosemide C Hypotension Leukocytosis Neuroleptic Malignant Syndrome Pyrexia Renal Failure Acute Tremor Vomiting Date:04/28/99ISR Number: 3248456-4Report Type:Direct Company Report # Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Risperdal PS ORAL 2MG PO BID Cogentin C 22-Feb-2006 08:20 AM Page: 575 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/99ISR Number: 3250141-XReport Type:Expedited (15-DaCompany Report #JRFBEL1999000061 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ileus Paralytic Foreign Risperidone Health (Unspecified) Professional (Risperidone) PS ORAL 3 MG, DAILY ORAL; 1 MG DAILY ORAL Iron Compounds C Date:04/29/99ISR Number: 3250269-4Report Type:Expedited (15-DaCompany Report #JAKYO043493 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperidone Myocardial Infarction Health (Unspecified) Professional (Risperidone) PS ORAL 3 MG, DAILY ORAL Fluphenazine Maleate C Sulpiride C Biperiden Hydrochloride C Date:04/29/99ISR Number: 3250273-6Report Type:Expedited (15-DaCompany Report #JAUSA35332 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Failure Health Risperdal Congestive Professional (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY ORAL Date:04/29/99ISR Number: 3250276-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999000082 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Keratitis Herpetic Foreign Risperdal Health (Risperidone) PS ORAL MG DAILY ORAL Professional Timiperone C Chlorpromazine Hydrochloride C Biperiden Hydrochloride C Promethazine Hydrochloride C Nifedipine C Daio-Kanzo-To C Sennoside C Fluphenazine C Date:04/30/99ISR Number: 3260940-6Report Type:Expedited (15-DaCompany Report #JAOCAN1999000062 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatinine Foreign Risperdal Increased Health (Unspecified) Nephritis Interstitial Professional (Risperidone) PS ORAL 22-Feb-2006 08:20 AM Page: 576 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/99ISR Number: 3252002-9Report Type:Expedited (15-DaCompany Report #JAFRA-43617 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Osmolarity Foreign Risperdal Initial or Prolonged Decreased Health (Risperidone) Tablet PS Janssen ORAL 4 MG 2 DAILY Brain Oedema Professional ORAL/2 MG 2 Coma DAILY ORAL Fall TABLET 4 MG/4 Grand Mal Convulsion MG 2 DAILY 21 DAY Hyponatraemia Hypothyroidism Inappropriate Antidiuretic Hormone Secretion Polydipsia Psychogenic Sedation Thirst Urine Osmolarity Increased Vomiting Date:05/03/99ISR Number: 3252126-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperidone 3 Mg Bid PS ORAL 3 MG PO BID Initial or Prolonged Phosphokinase Increased Other Coma Required Dialysis Intervention to Lethargy Prevent Permanent Muscle Rigidity Impairment/Damage Psychotic Disorder Date:05/04/99ISR Number: 3253810-0Report Type:Expedited (15-DaCompany Report #FLUV00399000016 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrial Fibrillation Foreign Fevarin PS ORAL PO 50 MG Hospitalization - Bundle Branch Block Right Health TID PO Initial or Prolonged Circulatory Collapse Professional Risperdal SS Deep Vein Thrombosis Other Cisday C Dyspnoea Amaryl C Hypotension Bifiteral C Pulmonary Embolism Isoglaucon C Tachycardia Trusopt C Date:05/05/99ISR Number: 3253954-3Report Type:Expedited (15-DaCompany Report #980604-008011956 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Delusion Foreign Haloperidol Tablets Hospitalization - Hallucination, Auditory Study (Haloperidol) PS ORAL 10 MG, 1 IN 1 Initial or Prolonged Schizophrenia Health DAY(S), ORAL Suicidal Ideation Professional Risperidone (Risperidone) SS ORAL 10 MG, 1 IN 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 577 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/99ISR Number: 3255465-8Report Type:Expedited (15-DaCompany Report #9913245 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Distension Health Zoloft Tablets PS ORAL 100.00MG Intervention to Abdominal Pain Upper Professional TOTAL DAILY Prevent Permanent Agitation ORAL Impairment/Damage Ascites Risperdal SS ORAL 1.00MG TOTAL Chills DAILY ORAL Condition Aggravated Risperidone C Decreased Appetite Dulcolax C Depression Motrin C Diarrhoea Relafen C Dizziness Acetaminophen C Dyspnoea Headache Hepatitis A Ileus Paralytic Laboratory Test Abnormal Nausea Oedema Peripheral Weight Increased X-Ray Gastrointestinal Tract Abnormal Date:05/06/99ISR Number: 3255583-4Report Type:Periodic Company Report #JAUSA35074 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pancytopenia Health Risperdal Intervention to Professional (Risperidone) PS (3 MG DAILY Prevent Permanent 28-FEB-96) : Impairment/Damage 1 MG IN AM, 2 MG AT BEDTIME. Sorbitol (Sorbitol) C Prempro (Provette/Generic) C Bisacodyl (Bisacodyl) C Multivitamins (Multivitamins) C Date:05/07/99ISR Number: 3256530-1Report Type:Expedited (15-DaCompany Report #JRFUSA1999000038 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Risperdal (1 Mg Fibrin Increased Professional Tablet) Lethargy (Risperidone) PS ORAL 4 MG, DAILY, Myocarditis ORAL Pericarditis Depakote C Shock Swelling 22-Feb-2006 08:20 AM Page: 578 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/99ISR Number: 3256540-4Report Type:Expedited (15-DaCompany Report #JRFUSA1999000040 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Health Risperdal (3 Mg Hospitalization - Phosphokinase Increased Professional Tablet) Initial or Prolonged Dialysis (Risperidone) PS ORAL 3 MG, 2 IN 1 Required Lethargy DAY(S), ORAL Intervention to Muscle Rigidity Moban (Molindone) SS ORAL ORAL Prevent Permanent Pneumothorax Trazadone C Impairment/Damage Renal Failure Klonopin C Rhabdomyolysis Ativan C Date:05/07/99ISR Number: 3256542-8Report Type:Expedited (15-DaCompany Report #JRFUSA19990000104 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Balance Disorder Consumer Risperdal (1 Mg Blepharospasm Tablet) Hemiplegia (Risperidone) PS ORAL 1 MG, 1 IN 1 Hypoaesthesia DAYS(S), ORAL Menorrhagia Klonopin C Mood Swings Claritin C Paraesthesia Zantac C Prilosec C Ambien C Date:05/07/99ISR Number: 3256630-6Report Type:Expedited (15-DaCompany Report #JAFIN43776 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Serenase(Haloperidol Required Condition Aggravated Health ) PS ORAL 0.5 MG, 2 IN Intervention to Electrocardiogram Qt Professional 1 DAY(S), Prevent Permanent Prolonged ORAL Impairment/Damage Glomerulonephritis Risperdal(Risperidon Chronic e) SS Haematemesis Truxal(Chlorprothixe Haemodialysis ne) SS ORAL 15 MG, 2 IN 1 Tachycardia DAY(S), ORAL Torsade De Pointes Seloken Zoc Ventricular Fibrillation (Metoprolol) C Ventricular Tachycardia Norvasc(Tablet) (Amlodipine) C Furesis(Tablet) (Furosemide) C Obsidan(Capsules) (Propranolol) C Calcium Carbonate(Tablet) (Calcium Carbonate) C Cipramil(Tablet)(Cit alopram) C Eprex(Ampoule)(Epoet in Alfa) C Beko Forte(Tablet) (Vitamine B Complex) C Ascorbin (Tablet) (Ascorbic Acid) C 22-Feb-2006 08:20 AM Page: 579 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/99ISR Number: 3256958-XReport Type:Expedited (15-DaCompany Report #JAGER-44017 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Risperdal Initial or Prolonged Benign Gastrointestinal Health (Risperidone), Neoplasm Professional Janssen, Tablet 2 Mg PS Janssen ORAL 2 MG 3 DAILY Biopsy Bone Marrow ORAL Abnormal Date:05/07/99ISR Number: 3256959-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999000106 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Inguinal Hernia Foreign Risperidone (Tablet) Initial or Prolonged Health (Risperidone) PS ORAL 2 MG DAILY Required Professional ORAL Intervention to Aniracetam C Prevent Permanent Nicergoline C Impairment/Damage Mazaticol C Oxypertine C Pravastatin Sodium C Date:05/10/99ISR Number: 3257865-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999000061 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Risperidone Initial or Prolonged Feeling Abnormal Health (Tablet)( Required Haematochezia Professional Risperidone) PS ORAL 3 MG, DAILY, Intervention to Hydronephrosis ORAL Prevent Permanent Ileus Paralytic Risperidone (Tablet) Impairment/Damage Mental Impairment (Risperidone) SS ORAL 1 MG, DAILY Speech Disorder ORAL Urinary Retention Sennosides (Sennosides) C Biperiden (Biperiden) C Flunitrazepam (Flunitrazepam) C Trimebutine (Trimebutine) C Sodium Ferrous Sulfate (Ferrous Sulfate) C Carbazochrome Sodium Sulfonate (Carbazochrome Sodium Sulfonate) C Teprenone (Terprenone) C Magnesium Oxide (Magnesium Oxide) C 22-Feb-2006 08:20 AM Page: 580 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/99ISR Number: 3257870-2Report Type:Expedited (15-DaCompany Report #JAUSA36522 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Congestive Cardiomyopathy Health Risperdal (Tablet) Coronary Artery Disease Professional (Risperidone) PS ORAL 3 MG, 2 IN 1 DAY(S), ORAL Date:05/10/99ISR Number: 3257909-4Report Type:Expedited (15-DaCompany Report #JAFIN43776 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Qt Foreign Risperdal Required Prolonged (Risperidone) PS (.5 MG 2 Intervention to Haemodialysis DAILY Prevent Permanent Tachycardia 01-JUL-97) Impairment/Damage Torsade De Pointes Serenase (Haloperidol) SS ORAL 0.5 MG, 2 IN 1 DAY (S), ORAL Truxal (Chlorprothixene) SS ORAL 15 MG, 2 IN 1 DAY (S) ORAL Seloken C Norvasc C Furesis C Obsidan C Calcium Carbonate C Cipramil C Eprex C Beko Forte C Ascorbin C Date:05/10/99ISR Number: 3258000-3Report Type:Expedited (15-DaCompany Report #JACGBR1999000021 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Qt Foreign Risperdal Prolonged Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Sulpiride (Sulpiride) C Procyclidine (Procyclidine) C Depo-Provera (Medroxyprogesterone Acetate) C Date:05/10/99ISR Number: 3258001-5Report Type:Expedited (15-DaCompany Report #JRFBEL1999000087 Age:50 YR Gender:Female I/FU:I Outcome Death Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:20 AM Page: 581 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Lower Foreign Risperdal Acidosis Literature (Unspecified) Acute Abdomen Health (Risperidone) PS ORAL MG, DAILY, Ascites Professional ORAL Blood Electrolytes Sodium Valproate Abnormal (Valproate Sodium) C Coma Trihexyphenidyl Cyanosis Hydrochloride Diarrhoea (Trihexyphenidyl Dyspnoea Hydrochloride) C Hepatic Enzyme Increased Hypotension Intestinal Perforation Melaena Pallor Pancytopenia Platelet Count Decreased Red Blood Cell Count Decreased Shock White Blood Cell Count Decreased Date:05/13/99ISR Number: 3260809-7Report Type:Direct Company Report # Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Risperidone Initial or Prolonged Blood Amylase Increased Professional (Risperidal) 0.5 Mg PS ORAL 0.5 MG HS, Lipase Increased PO Nausea Mirtazapine Pancreatitis (Remeron) 30mg SS ORAL 30MG HS, PO 6 DAY Vomiting Furosemide C Venlafaxine C Ginkgo And Omeprazole C Morphine C Hydergine C Notco C Premarin C Nefazodone C Alprazolam C Zanaflex C Midrin C Ranitidine C Date:05/13/99ISR Number: 3260834-6Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dyskinesia Health Risperdal 2mg Required Masked Facies Professional Janssen PS ORAL 2 1/2 MG PO Intervention to Muscle Rigidity QAM Prevent Permanent Impairment/Damage 22-Feb-2006 08:20 AM Page: 582 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/99ISR Number: 3260930-3Report Type:Expedited (15-DaCompany Report #JAUK43395 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Overdose Foreign Risperdal Respiratory Arrest Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, ORAL Hypnotic (Hypnotic) SS Didronel (Etidronic Acid) C Date:05/13/99ISR Number: 3260934-0Report Type:Expedited (15-DaCompany Report #JRFUSA1999000113 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Risperdal (1 Mg Initial or Prolonged Professional Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Date:05/13/99ISR Number: 3260942-XReport Type:Expedited (15-DaCompany Report #JRFBEL1999000133 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Foreign Risperdal (Tablet) Initial or Prolonged Positive Health (Risperidone) PS ORAL MG, DAILY, C-Reactive Protein Professional ORAL Increased Zyprexa (Olanzapine) SS ORAL DAILY, ORAL Creatinine Renal Klorproman Clearance Decreased (Chlorpromazine Drug Ineffective Hydrochloride) SS 50 MG, 3 IN 1 Extrapyramidal Disorder DAY(S) Headache Orsanil Liver Function Test (Thioridazine Abnormal Hydrochloride) SS 50 MG, 3 IN 1 Lupus-Like Syndrome DAY(S) Mental Impairment Cloxan Nail Disorder (Chlorprothixene Pyrexia Hydrochloride) SS 50 MG, 3 IN 1 Vomiting DAY(S) Minulet (Femodene) SS ORAL ORAL Date:05/13/99ISR Number: 3261063-2Report Type:Expedited (15-DaCompany Report #1999MOB0001 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Health Moban PS ORAL PO Hospitalization - Phosphokinase Increased Professional Risperdal SS ORAL 3 MG, 2 IN 1 Initial or Prolonged Dialysis DAY PO Other Lethargy Trazodone C Muscle Rigidity Klonopin C Pneumothorax Ativan C Renal Failure Rhabdomyolysis 22-Feb-2006 08:20 AM Page: 583 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/99ISR Number: 3261089-9Report Type:Expedited (15-DaCompany Report #970611-008011932 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Restlessness Foreign Haloperidol PS ORAL 2 MG, QD, Initial or Prolonged Suicidal Ideation Study ORAL Health Risperidone SS ORAL 2 MG, QD, Professional ORAL Date:05/13/99ISR Number: 3261092-9Report Type:Expedited (15-DaCompany Report #971202-008013270 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicidal Ideation Foreign Haloperidol Tablets PS ORAL 4 MG, QD, Study ORAL Health Risperidone SS ORAL 2 MG, QD, Professional ORAL Date:05/14/99ISR Number: 3262519-9Report Type:Expedited (15-DaCompany Report #JACFRA1999000018 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phlebitis Foreign Risperdal Initial or Prolonged Pulmonary Embolism Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:05/14/99ISR Number: 3262526-6Report Type:Expedited (15-DaCompany Report #JRFBEL1999000145 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Risperdal Hospitalization - Health (Risperidone) PS ORAL MG, DAILY, Initial or Prolonged Professional ORAL Date:05/14/99ISR Number: 3262539-4Report Type:Expedited (15-DaCompany Report #JRFBEL1999000132 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Bullous Foreign Risperdal (2 Mg Initial or Prolonged Mouth Ulceration Health Tablet) Pyrexia Professional (Risperidone) PS ORAL 2 TABLE, 2 IN Rash Papular 1 DAY (S), Rash Vesicular ORAL Stevens-Johnson Syndrome Tegretol Stomatitis Necrotising (Carbamazepine) SS Tranxene C Date:05/14/99ISR Number: 3262914-8Report Type:Expedited (15-DaCompany Report #980616-008012087 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Haloperidol PS ORAL 10 MG, QD, Initial or Prolonged Lethargy Study ORAL Schizophrenia Health Risperidone SS ORAL 5 MG, QD, Social Avoidant Behaviour Professional ORAL Weight Decreased 22-Feb-2006 08:20 AM Page: 584 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/99ISR Number: 3263703-0Report Type:Expedited (15-DaCompany Report #JRFBEL1999000134 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Risperdal Condition Aggravated Health (Unspecified) Delirium Professional (Risperidone) PS ORAL MG, DAILY, Pyrexia ORAL Loperamide (Loperamide) C Nicergoline (Nicergoline) C Amantadine Hcl (Amantadine) C Etizolam (Etizolam) C Date:05/17/99ISR Number: 3263828-XReport Type:Expedited (15-DaCompany Report #JACGBR1999000016 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Risperdal Hospitalization - Circulatory Collapse Health (Unspecified) ( Initial or Prolonged Cough Professional Risperidone) PS ORAL 6 MG, 2 IN 1 Haematemesis DAY (S), ORAL Schizophrenia Date:05/18/99ISR Number: 3329898-5Report Type:Periodic Company Report #S99-USA-00338-01 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Celexa PS Arthritis Professional Risperdal SS ORAL 3 MG PO Chest Pain Lithium C Insomnia Celex C Osteoarthritis Pyrexia Vasodilatation Date:05/19/99ISR Number: 3266939-8Report Type:Periodic Company Report #8-99034-089A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Health Effexor Xr Capsules PS ORAL 150 MG ONCE Headache Professional DAILY ORAL Unintended Pregnancy Risperdal (Risperidone) SS 1 MG TWICE DAILY UNKNOWN Date:05/21/99ISR Number: 3267552-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999000132 Age:15 YR Gender:Female I/FU:F Outcome PT Hospitalization - Conjunctivitis Initial or Prolonged Dermatitis Bullous Lymphadenopathy Mouth Ulceration Pyrexia Rash Papular 22-Feb-2006 08:20 AM Page: 585 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rash Vesicular Stevens-Johnson Syndrome Stomatitis Necrotising Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal (2 Mg Health Tablet) Professional (Risperidone) PS DOSE: 2 TABLETS BID Risperdal (2 Mg Tablet) (Risperidone) SS DOSE: 2 TABLETS BID Tegretol (Carbamazepine) SS ORAL 1 TABLET, 2 IN 1 DAYS (S), ORAL Akineton C Tranxene C Homeop. Prep. Unsp. C Nozinan C Microgynon C Date:05/21/99ISR Number: 3267554-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999000152 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aplastic Anaemia Foreign Risperdal Hospitalization - Haemoglobin Decreased Health (Unspecified) Initial or Prolonged Haemorrhagic Stroke Professional (Risperidone) PS ORAL DAILY, ORAL Pneumonia Perphenazine C Red Blood Cell Count Biperiden C Decreased White Blood Cell Count Decreased Date:05/24/99ISR Number: 3269092-XReport Type:Expedited (15-DaCompany Report #JRFBEL1999000134 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Foreign Risperdal Hospitalization - Delirium Health (Unspecified) Initial or Prolonged Dysarthria Professional (Risperidone) PS ORAL MG, DAILY , Dysphagia ORAL Muscle Rigidity Haloperidol (Tablet) Muscle Spasms (Haloperidol) SS ORAL MCG, DAILY , Pyrexia ORAL Renal Failure Lofepramine Respiratory Arrest Hydrochloride C Tremor Nicergoline C Amantadine Hcl C Etilozam C Zopiclone C Bromazepam C Aniracetam C Neurovitan C 22-Feb-2006 08:20 AM Page: 586 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/99ISR Number: 3269176-6Report Type:Expedited (15-DaCompany Report #JRFBEL1999000132 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Risperdal (2 Mg Initial or Prolonged Increased Health Tablet) Conjunctivitis Professional (Risperidone) PS 2 TABLETS BID Dermatitis Bullous Tegretol Eczema (Carbamazepine) SS ORAL 1 TABLE, 2 IN Lymphadenopathy 1 DAY(S) Mouth Ulceration Akineton (Biperiden Oliguria Hydrochloride) C Pyrexia Tranxene Rash Papular (Clorazepate Rash Vesicular Dipotassium) C Stevens-Johnson Syndrome Homeop. Prep. Stomatitis Necrotising Unsp(Homeop.Prep.Uns p) C Nozinan (Levomepromazine) C Microgynon (Eugynon) C Date:05/24/99ISR Number: 3269178-XReport Type:Expedited (15-DaCompany Report #JAOCAN1999000062 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Risperdal Initial or Prolonged Abdominal Pain Health (Unspecified) Required Blood Creatinine Professional (Risperidone) PS ORAL 0.5 MG, 2 IN Intervention to Increased 1 DAY(S) Prevent Permanent Blood Sodium Decreased Olanzapine Impairment/Damage Blood Urea Increased (Olanzapine) SS ORAL 2.5 MG, 1 IN Crystalluria 1 DAY(S) Dermatitis Thioridazine Dialysis (Thioridazine) C Nasopharyngitis Domeperidone Nephritis Interstitial (Domeperidone) C Oliguria Hydroxyzine Urinary Casts (Hydroxyzine) C Vomiting Timolol (Timolol) C Date:05/24/99ISR Number: 3283917-3Report Type:Periodic Company Report #JAUSA-37331 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Propulsid Drug Abuser (Cisapride), Janssen, Tablet 10 Mg PS Janssen ORAL 10 MG 2 DAILY ORAL Risperdal (Risperidone), Janssen, Tablet 1 Mg SS Janssen ORAL 1 MG 2 DAILY ORAL Prozac C 22-Feb-2006 08:20 AM Page: 587 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/99ISR Number: 3269488-6Report Type:Expedited (15-DaCompany Report #PRIUSA1999001034 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Topamax (Tablet) Hospitalization - Decubitus Ulcer Health Topiramate) PS ORAL 1000MG DAILY Initial or Prolonged Drug Level Above Professional ORAL Therapeutic Risperidone Hypertonia (Risperidone) SS ORAL ORAL Hyporeflexia Tegretol Injury (Carbamazepine) SS ORAL 400MG ORAL Intentional Overdose Benzodiazepine SS ORAL ORAL Medication Error Muscle Contractions Involuntary Pneumonitis Suicide Attempt Vocal Cord Disorder Vocal Cord Paralysis Date:05/25/99ISR Number: 3269496-5Report Type:Expedited (15-DaCompany Report #JRFBEL1999000134 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Haloperidol (Tablet) Hospitalization - Anorexia Health (Haloperidol) PS ORAL MCG, DAILY Initial or Prolonged Condition Aggravated Professional ORAL Decreased Appetite Risperdal Delirium (Unspecified) Dysarthria (Risperidone) SS ORAL MG DAILY ORAL Dysphagia Lofepramine Malnutrition Hydrochloride C Muscle Rigidity Nicergoline C Musculoskeletal Stiffness Amantadine Hcl C Pyrexia Zopiclone C Respiratory Arrest Bromazepam C Tremor Aniracetam C Neurovitan C Date:05/25/99ISR Number: 3270427-2Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Jaw Disorder Zyprexa 10 Mg 2 Q Hs PS Tardive Dyskinesia Risperidone 3mg 1 Q Trismus Hs SS Paxil C Date:05/27/99ISR Number: 3271185-8Report Type:Expedited (15-DaCompany Report #PRIUSA1999001034 Age:29 YR Gender:Male I/FU:I Outcome PT Life-Threatening Coma Hospitalization - Decubitus Ulcer Initial or Prolonged Drug Level Above Therapeutic Hemiparesis Hypertonia Muscle Contractions 22-Feb-2006 08:20 AM Page: 588 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Involuntary Overdose Pneumonitis Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Vocal Cord Disorder Foreign Risperidone Health (Risperidone) PS ORAL ORAL Professional Topamax (Tablet) (Topiramate) SS ORAL 1000 MG, DAILY, ORAL Tegretol (Carbamazepine) SS ORAL 400 MG, ORAL Benzodiazepine SS ORAL ORAL Date:05/27/99ISR Number: 3271209-8Report Type:Expedited (15-DaCompany Report #JRFBEL1999000170 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Risperdal Hospitalization - Complete Health (Unspecified) Initial or Prolonged Bradycardia Professional (Risperidone) PS ORAL MG, DAILY, Required Drug Interaction ORAL Intervention to Electrocardiogram Qt Bromperidol Prevent Permanent Prolonged (Bromperidol) SS ORAL MG, DAILY, Impairment/Damage Ileus Paralytic ORAL Respiratory Arrest Clofekton Ventricular Tachycardia (Clocapramine Hydrochloride) SS ORAL MG, DAILY, ORAL Dogmatyl (Sulpiride) SS ORAL ORAL Levomepromazine (Levomepromazine) SS ORAL MG, DAILY, ORAL Rilmazafone (Rilmazafone) SS ORAL MG, DAILY, ORAL Metligine C Date:05/27/99ISR Number: 3271231-1Report Type:Direct Company Report # Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperidone PS ORAL 2-8 MG QHS, Professional PO 1 YR Sertraline C Depakote C Buproprion C Date:05/28/99ISR Number: 3273389-7Report Type:Periodic Company Report #LITH002980028 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Lithium Carbonate Initial or Prolonged Hypertonia Professional Capsules 300 Mg Leukocytosis (Lithium) PS ORAL 300 MG , PER Neuroleptic Malignant ORAL Syndrome Luvox Tablets 50 Mg Pyrexia (Fluvoxamine Urinary Incontinence Maleate) SS ORAL PER ORAL Risperdal 22-Feb-2006 08:20 AM Page: 589 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) SS ORAL 4.5 MG , PER ORAL Thorazine (Chlorpromazine Hydrochloride) SS ORAL PER ORAL Effexor C Date:05/28/99ISR Number: 3273417-9Report Type:Periodic Company Report #LITH002980031 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Lithium (Lithium) PS ORAL ORAL Dyspnoea Professional Risperdal Weight Increased (Risperidone) SS ORAL 4 MG, PER ORAL Loestrin (Norethisterone Acetate, Ethinylestradiol) SS ORAL ONE TABLET PER DAY, PER ORAL Date:05/28/99ISR Number: 3273469-6Report Type:Periodic Company Report #8-98362-127A Age:102 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Overdose Consumer Serax Tablets PS ORAL 10 MG, AS Sedation NEEDED ORAL Stupor Risperdal (Risperidone) Tablets SS ORAL 0.25 MG TWICE DAILY - 5 MG TWICE DAILY TABLET (1 MG) GIVEN ORAL Cardizem Cd C Nitroglycerin (Nifendipine) C Nitroglycerin C Pepcid (Famotidine) C Remeron (Mirtazapine) C Synthroid (Levothyroxine) C Date:06/01/99ISR Number: 3275287-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999000108 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Haloperidol (Tablet) Initial or Prolonged Hepatitis Health (Haloperidol) PS ORAL MG, DAILY, Liver Function Test Professional ORAL Abnormal Risperidone (Tablet) (Risperidone) SS ORAL MG, DAILY, ORAL Nitrazepam C Tocopherol Acetate C Clotiazepam C 22-Feb-2006 08:20 AM Page: 590 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/99ISR Number: 3275290-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999000092 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Haloperidol Initial or Prolonged Blood Chloride Decreased Health (Unspecified) Blood Creatine Professional (Haloperidol) PS ORAL MG, DAILY, Phosphokinase Increased ORAL Blood Sodium Decreased Risperidone (Tablet) Confusional State (Risperidone) SS ORAL MG DAILY, Hyperhidrosis ORAL Leukocytosis Pipamperone Lymphopenia Dihydrochloride Muscle Rigidity (Unspecified) Neutrophilia (Pipamperone) SS ORAL MG, DAILY, Salivary Hypersecretion ORAL Thrombocythaemia Sultopride Hydrochloride (Sultopride Hydrochloride) SS ORAL MG, DAILY, ORAL Levomepromazine Hydrochloride (Levomepromazine) SS ORAL MG, DAILY, ORAL Promethazine Hydrochloride (Promethazine Hydrochloride) SS ORAL MG, DAILY, ORAL Sennosides (Sennosides) SS ORAL MG, DAILY, ORAL Famotidine (Famotidine) SS ORAL MG, DAILY, ORAL Cetilo SS ORAL DAILY, ORAL Teprenone (Teprenone) SS ORAL MG, DAILY, ORAL Vegetamin-A (Vegetamin A) SS ORAL ORAL Zotepine (Zotepine) SS ORAL MG, DAILY, ORAL Flunitrazepam (Flunitrazepam) SS ORAL MG, DAILY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) SS ORAL MG, DAILY, ORAL Date:06/02/99ISR Number: 3274299-1Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Relafen PS Smithkline Risperdal (Risperidone) SS Janssen 22-Feb-2006 08:20 AM Page: 591 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/99ISR Number: 3276801-2Report Type:Expedited (15-DaCompany Report #JAUK43909 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abortion Induced Foreign Risperdal Congenital Anomaly Complications Of Maternal Health (Unspecified) Exposure To Therapeutic Professional (Risperidone) PS 3 MG DAILY : Drugs TAKEN BY Congenital Central MOTHER FOR Nervous System Anomaly SEVERAL YEARS Head Deformity FOR Meningomyelocele Procyclidine C Multiple Congenital Clomiphene C Abnormalities Date:06/04/99ISR Number: 3276804-8Report Type:Expedited (15-DaCompany Report #JAFRA42175 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Foreign Risperdal (2 Mg Initial or Prolonged Bronchitis Health Tablet) Required Coma Professional (Risperidone) PS ORAL 2 MG, 3 IN 1 Intervention to Dyskinesia DAY(S), ORAL Prevent Permanent Hyporeflexia ; 4 MG, 1 IN Impairment/Damage Lower Respiratory Tract 1 DAILY, Infection ORAL; 6 MG, 1 Lung Disorder Risperdal (1 Mg/Ml Nasopharyngeal Disorder Oral Suspension) Pyrexia (Risperidone) SS ORAL 2 MG, 1 IN 1 Tracheitis DAILY ORAL Nozinan C Rivotril C Depakine C Valium C Date:06/04/99ISR Number: 3276847-4Report Type:Expedited (15-DaCompany Report #JAUSA36992 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Disorder Consumer Risperdal (Tablet) Initial or Prolonged Lymphadenopathy Health (Risperidone) PS (3 MG 2 DAILY Required Platelet Count Decreased Professional 15-JAN-95) : Intervention to ESTIMATED Prevent Permanent START DATE Impairment/Damage Depakote (Tablet 1000 Mg) (Valproate Sodium) C Buspar (Tablet 5 Mg) (Buspirone) C Amaryl (Tablet 1 Mg) (Glimepiride) C Date:06/04/99ISR Number: 3276852-8Report Type:Expedited (15-DaCompany Report #JRFBEL1999000214 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Foreign Risperdal (Tablet) Ileus Paralytic Health (Risperidone) PS ORAL MG DAILY ORAL Professional Chlorpromazine And 22-Feb-2006 08:20 AM Page: 592 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Preparations C Levomepromazine Maleate C Carbamazepine C Trihexyphenidyl Hydrochloride C Date:06/07/99ISR Number: 3277450-2Report Type:Expedited (15-DaCompany Report #JRFUSA1999000424 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Consumer Risperdal (Tablet) Initial or Prolonged Haematocrit Decreased (Risperidone) PS ORAL ORAL Required Haemorrhage Prolixin C Intervention to Prevent Permanent Impairment/Damage Date:06/07/99ISR Number: 3277455-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999000245 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal (1 Mg Cerebrovascular Disorder Health Tablet) Confusional State Professional (Risperidone) PS ORAL 0.5 MG , 2 IN Dizziness 1 DAY (S) , Hallucination ORAL Hypothermia Impugan C Oedema Peripheral Levaxin C Date:06/07/99ISR Number: 3277695-1Report Type:Direct Company Report # Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiovascular Disorder Risperdal 2mg PS 2MG 2X DAY Hospitalization - Coma Initial or Prolonged Dyspnoea Disability Hypotension Required Oxygen Saturation Intervention to Decreased Prevent Permanent Paralysis Impairment/Damage Respiratory Disorder Date:06/08/99ISR Number: 3278946-XReport Type:Direct Company Report # Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypotension Zoloft PS ORAL 50MG PO Q AM Risperdol SS ORAL 0.5 MG PO QD Nelosef SS ORAL 250MG PO Q 6H Motrin C Tylenol C Baurovin C 22-Feb-2006 08:20 AM Page: 593 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/99ISR Number: 3278955-0Report Type:Expedited (15-DaCompany Report #JRFBEL1999000262 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Literature Risperidone Initial or Prolonged Consciousness Health (Unspecified) Electroencephalogram Professional (Risperidone) PS ORAL MG, DAILY, Abnormal ORAL Nuclear Magnetic Resonance Imaging Brain Abnormal Date:06/09/99ISR Number: 3278956-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999000261 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Laryngopharyngitis Foreign Risperidone (Tablet) Initial or Prolonged Nasopharyngitis Health (Risperidone) PS ORAL MG, DAILY, Pyrexia Professional ORAL Stomatitis Biperiden Hydrochloride (Biperiden Hydrochloride) C Flunitrazepam (Flunitrazepam) C Sulpiride (Sulpiride) C Nitrazepam (Nitrazepam) C Date:06/09/99ISR Number: 3278961-6Report Type:Expedited (15-DaCompany Report #JRFUSA1999000082 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Facial Palsy Consumer Risperdal (1 Mg Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Ariceppt (Donepeil Hydrochloride) C Vitamin E (Tocopherol) C Ginko Biloba (Herbal Preparation) C Ginger Tabs (Herbal Preparation) C Date:06/09/99ISR Number: 3279039-8Report Type:Expedited (15-DaCompany Report #JRFBEL1999000134 Age:82 YR Gender:Female I/FU:F Outcome PT Death Anorexia Hospitalization - Cardiac Failure Initial or Prolonged Cardiovascular Disorder Condition Aggravated Decreased Appetite Delirium Dysarthria 22-Feb-2006 08:20 AM Page: 594 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysphagia Hallucination Hypertonia Report Source Product Role Manufacturer Route Dose Duration Insomnia Foreign Haloperidol (Tablet) Malnutrition Health (Haloperidol) PS ORAL MCG, DAILY, Muscle Rigidity Professional ORAL Pyrexia Risperdal Renal Failure (Unspecified) Respiratory Arrest (Risperidone) SS ORAL MG, DAILY, Tremor ORAL Aniracetam (Aniracetam0 SS ORAL MG, DAILY, ORAL Lofepramine Hydrochloride C Nicergoline C Amantadine Hcl C Bromazepam C Neurovitan C Date:06/09/99ISR Number: 3279046-5Report Type:Expedited (15-DaCompany Report #JRFBEL1999000275 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Haldol (Unspecified) Initial or Prolonged Overdose Health (Haloperidol) PS ORAL ORAL Professional Risperdal (Unspecified) (Risperidone) SS ORAL ORAL Date:06/09/99ISR Number: 3279216-6Report Type:Expedited (15-DaCompany Report #7398177 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Health Abbott-Depakote PS Abbott ORAL 1.000 GM QD Intervention to Ambulatory Abnormal Professional Risperdal SS Prevent Permanent Palpitations Impairment/Damage Sinus Arrhythmia Ventricular Extrasystoles Ventricular Tachycardia Date:06/09/99ISR Number: 3279319-6Report Type:Expedited (15-DaCompany Report #JRFBEL1999000134 Age:82 YR Gender:Female I/FU:F Outcome PT Death Anorexia Hospitalization - Condition Aggravated Initial or Prolonged Decreased Appetite Delirium Dysarthria Dysphagia Eating Disorder Fall Hypertonia Malnutrition Muscle Rigidity Pyrexia Respiratory Arrest 22-Feb-2006 08:20 AM Page: 595 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Speech Disorder Tremor Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Unspecified)(Risper Professional idone) PS ORAL MG, DAILY, ORAL Haloperidol (Tabler)(Haloperidol ) SS ORAL MCG, DAILY, ORAL Aniracetam (Aniracetam) SS ORAL MG, DAILY, ORAL Lofepramine Hydrochloride C ORAL MG, DAILY, ORAL Nicergoline C Amantadine Hcl C Bromazepam C Neurovitan C Date:06/10/99ISR Number: 3280033-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Autonomic Nervous System Risperdal PS 1 MG BID 2 MG Hospitalization - Imbalance HS Initial or Prolonged Condition Aggravated Anafranil 150 Mg Hs SS 150 MG HS Dyskinesia Hyperpyrexia Mental Impairment Neuroleptic Malignant Syndrome Date:06/10/99ISR Number: 3281292-1Report Type:Expedited (15-DaCompany Report #JAUSA36522 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Risperdal (Tablet) Congestive Cardiomyopathy Professional (Risperidone) PS ORAL 3 MG 2 IN 1 Coronary Artery Disease DAY ORAL Date:06/10/99ISR Number: 3281293-3Report Type:Expedited (15-DaCompany Report #JAUSA37136 Age:30 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Culture Urine Positive Drug Interaction Encephalopathy Extrapyramidal Disorder Hypernatraemia Hypotension Muscle Rigidity Neuroleptic Malignant Syndrome 22-Feb-2006 08:20 AM Page: 596 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pseudomonas Infection Pyrexia Tachycardia Report Source Product Role Manufacturer Route Dose Duration Tremor Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 1.5 MG 1 IN 1 DAY ORAL Norvir (Ritonavir) SS ORAL 400MG, 2 IN 1 DAY, ORAL Sporanox C Crixivan C Didanosine C Biaxin C Prednisone C Bactrim Ds C Ethambutol C Cipro C Amphotericin B C Tylenol C Benadryl C Ativan C Date:06/10/99ISR Number: 3281335-5Report Type:Expedited (15-DaCompany Report #JAUK43400 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Risperdal (2mg Initial or Prolonged Depressed Level Of Health Tablet) Consciousness Professional (Risperidone) PS ORAL 2 MG, DAILY, Hypercalcaemia ORAL Metastases To Lung Risperdal (2 Mg Overdose Tablet) Sedation (Risperidone) SS Stupor Date:06/11/99ISR Number: 3281938-8Report Type:Expedited (15-DaCompany Report #JACFRA1999000064 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Foreign Risperdal Hospitalization - Depressed Level Of Health (Unspecified) Initial or Prolonged Consciousness Professional (Risperidone) PS ORAL MG, DAILY, Required Hyponatraemia ORAL Intervention to Vomiting Prevent Permanent Impairment/Damage Date:06/14/99ISR Number: 3282607-0Report Type:Expedited (15-DaCompany Report #A044-002-001576 Age:80 YR Gender:Female I/FU:I Outcome PT Hospitalization - Coordination Abnormal Initial or Prolonged Dizziness Dizziness Postural Electroencephalogram Abnormal Fall Gait Disturbance 22-Feb-2006 08:20 AM Page: 597 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Report Source Product Role Manufacturer Route Dose Duration Foreign Aricept (Donepezil) PS ORAL 5 MG (1 IN 1 Health D), PER ORAL Professional Risperdal (Risperidone) SS ORAL 2 MG, PER ORAL Date:06/15/99ISR Number: 3285181-8Report Type:Expedited (15-DaCompany Report #1999CAP0003 Age:63 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Captopril Health (Captopril) PS ORAL PO Professional (Diltiazem) SS ORAL PO (Risperidone) SS ORAL PO Date:06/16/99ISR Number: 3284106-9Report Type:Direct Company Report # Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Risperidone PS Initial or Prolonged Dysarthria Muscle Rigidity Musculoskeletal Stiffness Date:06/16/99ISR Number: 3284254-3Report Type:Expedited (15-DaCompany Report #JACGBR1999000123 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Acute Foreign Risperdal Rhabdomyolysis Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:06/16/99ISR Number: 3284256-7Report Type:Expedited (15-DaCompany Report #JRFUSA1999000617 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hodgkin'S Disease Health Risperdal (Tablet) Hospitalization - Liver Function Test Professional (Risperidone) PS ORAL 3.5 MG, Initial or Prolonged Abnormal DAILY, ORAL Required Cytoxan C Intervention to Acyclovir C Prevent Permanent Impairment/Damage Date:06/16/99ISR Number: 3284789-3Report Type:Expedited (15-DaCompany Report #JRFUSA1999000578 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Chloride Increased Health Risperdal (Tablet) Initial or Prolonged Blood Sodium Increased Professional (Risperidone) PS ORAL 2 MG, 1 IN 1 Dehydration DAY(S), ORAL Diabetes Insipidus Depakote (Valproate Hypotension Semisodium) C 22-Feb-2006 08:20 AM Page: 598 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trazodone (Trazodone) C Ativan (Lorazepam) C Date:06/16/99ISR Number: 3285133-8Report Type:Expedited (15-DaCompany Report #JRFBEL1999000311 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Foreign Haldol (Unspecified) Irritability Health (Haloperidol) PS ORAL MG, DAILY, Suicidal Ideation Professional ORAL Risperidone (Tablet) (Risperidone) SS ORAL MG, DAILY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Vegetamin A C Zopiclone (Zopiclone) C Ruefrien (Ruefrien) C Vegetamin B (Vegetamin B (R)) C Date:06/17/99ISR Number: 3286266-2Report Type:Expedited (15-DaCompany Report #A0094748 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Health Lamictal Tablet PS ORAL SINGLE DOSE Hospitalization - Aspiration Professional Cabapentin Capsule SS ORAL SINGLE DOSE Initial or Prolonged Electrocardiogram Qrs Fluoxetine Other Complex Prolonged Hydrochloride SS ORAL Intentional Overdose Risperidone SS ORAL Lung Infiltration Methylphenidate SS ORAL Suicide Attempt Thioridazine SS Tachypnoea Ethanol SS ORAL Ventricular Tachycardia Vomiting Date:06/18/99ISR Number: 3286509-5Report Type:Expedited (15-DaCompany Report #JACGER1999000122 Age:39 YR Gender:Female I/FU:I Outcome PT Life-Threatening Blood Creatine Hospitalization - Phosphokinase Increased Initial or Prolonged Chills Required Cognitive Disorder Intervention to Condition Aggravated Prevent Permanent Electroencephalogram Impairment/Damage Abnormal Neuroleptic Malignant Syndrome Pneumonia Aspiration Psychotic Disorder Psychotic Disorder Due To A General Medical Condition 22-Feb-2006 08:20 AM Page: 599 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Stupor Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Unspecified Tablet) Professional (Risperidone) PS ORAL 2 MG, DAILY, ORAL Date:06/18/99ISR Number: 3286510-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999000134 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Risperdal Hospitalization - Anorexia Health (Unspecified) Initial or Prolonged Cardiac Failure Professional (Risperidone) PS ORAL MG, DAILY, Condition Aggravated ORAL Delirium Haloperidol (Tablet) Dysarthria (Haloperidol) SS ORAL MCG, DAILY, Dysphagia ORAL Hypertonia Aniracetam Malnutrition (Aniracetam) SS ORAL MG, DAILY, Muscle Rigidity ORAL Musculoskeletal Stiffness Lofepramine Oral Intake Reduced Hydrochloride Pyrexia (Lofepramine Respiratory Arrest Hydrochloride) C Tremor Nicergoline (Nicergoline) C Amantadine Hcl (Amantadine Hydrochloride) C Bromazepam (Bromazepam) C Neurovitan (Neurovitan) C Date:06/18/99ISR Number: 3286518-6Report Type:Expedited (15-DaCompany Report #7398151 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ecchymosis Health Abbott - Depakote PS ORAL 1.250 GM PO Initial or Prolonged Idiopathic Professional QD Other Thrombocytopenic Purpura Other Risperdal SS ORAL 2.00 MG PO Medication Error BID Red Blood Cell Count Haldol C Decreased Lithium C Schizophrenia Nifedipine C White Blood Cell Count Increased Date:06/21/99ISR Number: 3288122-2Report Type:Expedited (15-DaCompany Report #JACGER1999000126 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal Initial or Prolonged Health (Unspecified Tablet) Professional (Risperidone) PS ORAL 6 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 600 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leponex (Clozapine) SS 12.5 MG, DAILY Diazepam C Date:06/22/99ISR Number: 3288977-1Report Type:Expedited (15-DaCompany Report #1191226A Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Unknown Drug Level Above Health Acetaminophen Therapeutic Professional Product PS ORAL UNKNOWN DOSE, PO Risperidone SS ORAL UNKNOWN DOSE, PO Date:06/23/99ISR Number: 3289886-4Report Type:Expedited (15-DaCompany Report #JRFBEL1999000344 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperidone (Tablet) Initial or Prolonged Delusion Health (Risperidone) PS ORAL MG, DAILY, Subdural Haematoma Professional ORAL Cloxazolam C Trihexyphenidyl Hydrochloride C Biperiden Hydrochloride C Bromperidol C Vegetamin A C Levomepromazine Maleate C Sennoside C Flunitrazepam C Nitrazepam C Voglibose C Alosenn C Date:06/23/99ISR Number: 3289887-6Report Type:Expedited (15-DaCompany Report #JAKY043538 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Risperidone (Tablet) Initial or Prolonged Dyskinesia Health (Risperidone) PS ORAL 6 MG, DAILY, Salivary Hypersecretion Professional ORAL Stomatitis Bromperidol (Unspecified) (Bromperidol) SS ORAL 3 MG, DAILY, ORAL (SEE IMAGE) Haloperidol Decanoate (Injection) (Haloperidol Decanoate) SS INTRAVENOUS DRIP (100 MG DAILY 24-AUG-98) (50 MG DAILY 14-OCT-98) 22-Feb-2006 08:20 AM Page: 601 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Biperiden Hydrochloride C Sennoside (Tablet) C Tolbutamide (Tablet) C Date:06/23/99ISR Number: 3290024-2Report Type:Expedited (15-DaCompany Report #USA/99/01161/PAM Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Pamelor Initial or Prolonged (Nortriptyline Required Hydrochloride) PS ORAL 50 MG, ONCE A Intervention to DAY Prevent Permanent Risperdal SS ORAL 2 MG, ONCE A Impairment/Damage DAY Zantac (Ranitidine Hydrochloride) C Singulair (Montelukast) C Cromolyn Sodium (Cromoglicate Sodium) C Reglan (Metoclopramide) C Date:06/24/99ISR Number: 3291141-3Report Type:Expedited (15-DaCompany Report #JAOCAN1999000130 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Consumer (Unspecified) Health (Risperidone) PS ORAL ORAL Professional Imipramine (Imipramine) SS ORAL ORAL Date:06/24/99ISR Number: 3291143-7Report Type:Expedited (15-DaCompany Report #JAOCAN1999000131 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Consumer (Unspecified) Health (Risperidone) PS ORAL ORAL Professional Imipramine (Imipramine) SS ORAL ORAL Date:06/24/99ISR Number: 3291144-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999000355 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL MG, DAILY, ORAL Lopirin C Lasix C 22-Feb-2006 08:20 AM Page: 602 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/99ISR Number: 3291145-0Report Type:Expedited (15-DaCompany Report #JRFUSA1999000781 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Risperdal (1 Mg Initial or Prolonged Hypernatraemia Professional Tablet) Required (Risperidone) PS ORAL 1 MG, 2 IN 1 Intervention to DAY (S), ORAL Prevent Permanent Depakote C Impairment/Damage Klonopin C Vasopressin C Date:06/24/99ISR Number: 3291146-2Report Type:Expedited (15-DaCompany Report #JRFUSA1999000787 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Hypoxia Health Risperdal (Tablet) Initial or Prolonged Hypoxia Professional (Risperidone) PS ORAL ORAL Pulmonary Oedema Local Anaesthetic (Local-Anaesthetic) SS Date:06/24/99ISR Number: 3291147-4Report Type:Expedited (15-DaCompany Report #JACGBR1999000138 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiovascular Disorder Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Date:06/24/99ISR Number: 3291148-6Report Type:Expedited (15-DaCompany Report #JACGBR1999000139 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiovascular Disorder Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Date:06/24/99ISR Number: 3291149-8Report Type:Expedited (15-DaCompany Report #JRFUSA1999000082 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Palsy Health Risperdal (1 Mg Sedation Professional Tablet) Tremor (Risperidone) PS ORAL SEE IMAGE Aricept C Vitamin E C Ginko C Ginger Tabs C Ambien C Date:06/24/99ISR Number: 3291150-4Report Type:Expedited (15-DaCompany Report #JAUSA35074 Age:51 YR Gender:Female I/FU:F Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:20 AM Page: 603 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Megaloblastic Health Risperdal (3 Mg Blood Iron Decreased Professional Tablet) Ecchymosis (Risperidone) PS SEE IMAGE Marrow Hyperplasia Sorbitol C Myelodysplastic Syndrome Prempro C Oxygen Saturation Bisacodyl C Decreased Multivitamins C Pancytopenia Platelet Count Decreased Date:06/28/99ISR Number: 3292869-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999000367 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nasopharyngitis Foreign Risperidone Initial or Prolonged Health (Unspecified Tablet) Professional (Risperidone) PS ORAL MG, DAILY Biperiden Hydrochloride (Biperiden Hydrochloride) C Aldioxa (Aldioxa) C Levomepromazine Maleate (Levomepromazine Maleate) C Alprazolam (Alprazolam) C Diazepam (Diazepam) C Flunitrazepam (Flunitrazepam) C Date:06/28/99ISR Number: 3292871-XReport Type:Expedited (15-DaCompany Report #JRFBEL1999000351 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pancytopenia Foreign Risperidone Health (Unspecified) Professional (Risperidone) PS ORAL MG, DAILY Haloperidol (Unspecified) (Haloperidol) C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Diazepam (Diazepam) C Date:06/28/99ISR Number: 3292952-0Report Type:Expedited (15-DaCompany Report #JACAN16858 Age:23 YR Gender:Male I/FU:F Outcome PT Death Circulatory Collapse Heat Exhaustion Heat Stroke 22-Feb-2006 08:20 AM Page: 604 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Temperature Regulation Disorder Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal (2 Mg Literature Tablet) Health (Risperidone) PS ORAL 4 MG, 2 IN 1 Professional DAY(S), ORAL Benztropine (Benzatropine Mesilate) SS ORAL 2 MG, 1 IN 1 DAY(S), ORAL Ranitidine C Clonazepam C Date:06/28/99ISR Number: 3293295-1Report Type:Expedited (15-DaCompany Report #JRFUSA1999000866 Age:39 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Tranylcypromine (Tranylcypromine) SS ORAL ORAL Fluoxetine (Fluoxetine) SS ORAL ORAL Date:06/29/99ISR Number: 3295220-6Report Type:Expedited (15-DaCompany Report #JRFBEL1999000275 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Haldol (Tablet) Initial or Prolonged Loss Of Consciousness Health (Haloperidol) PS ORAL MG, DAILY, Suicide Attempt Professional ORAL Risperdal (Tablet) (Risperidone) SS ORAL MG, DAILY, ORAL Brotizolam C Zopiclone C Nitrazepam C Promethazine Hydrochloride C Date:07/01/99ISR Number: 3294917-1Report Type:Direct Company Report # Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Risperidone 1mg Intervention to Jaw Disorder Janssen Ortho PS Janssen Ortho 1MG BID Prevent Permanent Muscle Rigidity Impairment/Damage Paranoia Parkinsonian Gait Tardive Dyskinesia Tongue Disorder 22-Feb-2006 08:20 AM Page: 605 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/99ISR Number: 3298563-5Report Type:Expedited (15-DaCompany Report #JAOCAN1999000131 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Consumer (Unspecified) Health (Risperidone) PS ORAL ORAL Professional Imipramine (Imipramine) SS ORAL ORAL Date:07/01/99ISR Number: 3298727-0Report Type:Expedited (15-DaCompany Report #JAOCAN1999000130 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Consumer (Unspecified) Health (Risperidone) PS ORAL ORAL Professional Date:07/01/99ISR Number: 3298742-7Report Type:Expedited (15-DaCompany Report #JRFBEL1999000433 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Date:07/01/99ISR Number: 3298745-2Report Type:Expedited (15-DaCompany Report #JRFUSA1999000868 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Infertility Female Consumer Risperdal (Tablet) Medication Error (Risperidone) PS ORAL ORAL Date:07/01/99ISR Number: 3298752-XReport Type:Expedited (15-DaCompany Report #JRFUSA1999000845 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Health Risperdal (1mg Initial or Prolonged Blood Alkaline Professional Tablet) Phosphatase Increased (Risperidone) PS ORAL 1MG, 2 IN 1 Blood Amylase Increased DAY (S) ORAL Bowel Sounds Abnormal Depakote (Valproate Pancreatitis Semisodium) SS ORAL ORAL Staphylococcal Infection Dilantin (Phenytoin Vomiting Sodium) SS Date:07/02/99ISR Number: 3298566-0Report Type:Expedited (15-DaCompany Report #JACFRA1999000142 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Risperdal Initial or Prolonged Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Tranxene C Cordarone C Nitriderm C 22-Feb-2006 08:20 AM Page: 606 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lasilix C Insuline Nordisk C Aldalix C Diffu K C Clivarine C Date:07/02/99ISR Number: 3298567-2Report Type:Expedited (15-DaCompany Report #JACGBR1999000147 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Delta Foreign Risperdal Waves Abnormal Health (Unspecified) Myocardial Infarction Professional (Risperidone) PS ORAL 2 MG, 2 IN 1 Myocardial Ischaemia DAILY, ORAL Date:07/06/99ISR Number: 3298165-0Report Type:Expedited (15-DaCompany Report #JAGER43791 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arterial Occlusive Foreign Risperdal Disease Health (Unspecified) Deep Vein Thrombosis Professional (Risperidone) PS ORAL ORAL Hypersensitivity Remergil C Lethargy Pulmonary Embolism Thrombosis Date:07/06/99ISR Number: 3298172-8Report Type:Expedited (15-DaCompany Report #JRFBEL1999000351 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Foreign Risperidone Leukopenia Health (Unspecified) Pancytopenia Professional (Risperidone) PS ORAL SEE IMAGE Haloperidol C Chlorpromazine C Diazepam C Date:07/06/99ISR Number: 3298177-7Report Type:Expedited (15-DaCompany Report #JACFRA1999000018 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phlebitis Foreign Risperdal Initial or Prolonged Pulmonary Embolism Health (Unspecified) Professional (Risperidone) PS ORAL MG , DAILY, ORAL Levothyrox C Lepticur C Tercian C Date:07/06/99ISR Number: 3298181-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999000407 Age:81 YR Gender:Female I/FU:I Outcome PT Hospitalization - Cholecystitis Initial or Prolonged Depressed Level Of 22-Feb-2006 08:20 AM Page: 607 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Consciousness Fall Head Injury Jaundice Report Source Product Role Manufacturer Route Dose Duration Foreign Risperidone Health (Unspecified Tablet) Professional (Risperidone) PS ORAL MG, DAILY , ORAL Alprazolam C Estazolam C Biperiden C Chlorpromazine Hydrochloride C Date:07/06/99ISR Number: 3298300-4Report Type:Expedited (15-DaCompany Report #JAUSA37115 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal (1 Mg Blood Prolactin Increased Tablet) Cerebrovascular Accident (Risperidone) PS ORAL 1 MG, 1 IN 1 Emotional Disorder DAY(S), ORAL Empty Sella Syndrome Prozac C Galactorrhoea Zestril C Headache Procardia C Hypoaesthesia Axid C Muscle Twitching Darvocet C Thyroid Gland Cancer Xanax C Thyroid Neoplasm Bentyl C Visual Disturbance Prilosec C Ambien C Claritin-D C Ibuprofen C Amitriptyline C Cyclobenzaprine C Lotensin C Date:07/06/99ISR Number: 3298308-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999000459 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal Initial or Prolonged Phosphokinase Increased Health (Unspecified) Myositis Professional (Risperidone) PS CURRENT DOSE: Respiratory Arrest 2 MG OD 4 YR Date:07/06/99ISR Number: 3298318-1Report Type:Expedited (15-DaCompany Report #JACGBR1999000163 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Foreign Risperdal Initial or Prolonged Health (Unspecified) Professional (Risperidone) PS ORAL 6 MG, 1 IN 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 608 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/99ISR Number: 3298379-XReport Type:Expedited (15-DaCompany Report #JAGER43791 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arterial Occlusive Foreign Risperdal Disease Health (Unspecified) Deep Vein Thrombosis Professional (Risperidone) PS ORAL ORAL Hypersensitivity Remergil C Pulmonary Embolism Date:07/06/99ISR Number: 3300833-9Report Type:Periodic Company Report #203305 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Klonopin Tablets Professional (Clonazepam) PS ORAL 1.5 MG 1 PER DAY ORAL Risperdal (Risperidone) SS ORAL ORAL Date:07/07/99ISR Number: 3298523-4Report Type:Expedited (15-DaCompany Report #JACFRA1999000149 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Haldol Decanoas (50 Initial or Prolonged Intentional Overdose Health Mg/Ml Injection) Suicide Attempt Professional (Haloperidol Decanoate) PS INTRAMUSCULAR Risperdal (Unspecified) (Risperidone) SS ORAL Date:07/07/99ISR Number: 3298638-0Report Type:Expedited (15-DaCompany Report #JRFBEL1999000275 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Risperdal (Tablet) Initial or Prolonged Loss Of Consciousness Health (Risperidone) PS ORAL MG, DAILY, Required Schizophrenia Professional ORAL Intervention to Suicide Attempt Haldol C Prevent Permanent Brotizolam C Impairment/Damage Zopiclone C Promethazine Hydrochloride C Triazolam C Date:07/07/99ISR Number: 3298641-0Report Type:Expedited (15-DaCompany Report #JACFRA1999000139 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Haldol (5 Mg Tablet) Initial or Prolonged Pancreatitis Acute Health (Haloperidol) PS ORAL MG, TOTAL, Suicide Attempt Professional ORAL Risperdal (2 Mg Tablet) (Risperidone) SS ORAL MG, TOTAL, ORAL Aspirine 22-Feb-2006 08:20 AM Page: 609 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Acetylsalicylic Acid) SS ORAL G, TOTAL, ORAL Solian (Amisulpride) SS ORAL G, TOTAL, ORAL Augmentin (Augmentin Injection) SS INTRAVENOUS G, TOTAL, IV Athymil C Temesta C Rohypnol C Valium C Tercian C Equanil C Tranxene C Mopral C Date:07/08/99ISR Number: 3299570-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999000407 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Foreign Risperidone Initial or Prolonged Cholecystitis Health (Unspecified Tablet) Depressed Level Of Professional (Risperidone) PS ORAL MG, DAILY, Consciousness ORAL Fall Risperidone Jaundice (Unspecified Tablet) Muscle Spasms (Risperidone) SS ORAL MG, DAILY, Subdural Haematoma ORAL Alprazolam C Estazolam C Biperiden Hydrochloride C Chlorpromazine Hydrochloride C Date:07/08/99ISR Number: 3299576-XReport Type:Expedited (15-DaCompany Report #JACGBR1999000016 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Poisoning Foreign Risperdal Hospitalization - Aspiration Health (Unspecified) Initial or Prolonged Circulatory Collapse Professional (Risperidone) PS ORAL 6 MG, 2 IN 1 Cough DAY(S), ORAL Delusion Risperdal Haematemesis (Unspecified) Pulmonary Oedema (Risperidone) SS Snoring Date:07/08/99ISR Number: 3299581-3Report Type:Expedited (15-DaCompany Report #JRFBEL1999000433 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL MG, DAILY, ORAL Lysanxia C 22-Feb-2006 08:20 AM Page: 610 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/99ISR Number: 3301930-4Report Type:Expedited (15-DaCompany Report #JACFRA1999000152 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Foreign Haldol (5 Mg Tablet) Initial or Prolonged Health (Haloperidol) PS ORAL 5 MG, 1 IN 1 Professional DAY(S), ORAL Company Risperdal (2 Mg Representative Tablet) (Risperidone) SS ORAL MG, DAILY, ORAL Temesta (Lorazepam) SS ORAL ORAL Date:07/13/99ISR Number: 3302490-4Report Type:Expedited (15-DaCompany Report #JACFRA1999000153 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thirst Foreign Haldol (Solution) Initial or Prolonged Weight Decreased Health (Haloperidol) PS ORAL ORAL Professional Risperdal Company (Tablet)(Risperidone Representative ) SS ORAL MG, DAILY, ORAL Nozinan C Depakine C Date:07/14/99ISR Number: 3303823-5Report Type:Expedited (15-DaCompany Report #JACFRA1999000120 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Foreign Risperdal (4 Mg Initial or Prolonged Fall Health Tablet) Other Professional (Risperidone) PS ORAL 4 MG, 1 IN 1 Company DAY(S) , ORAL Representative Imovane (Zopiclone) SS ORAL 7.5 MG, 1 IN 1 DAY(S) , ORAL Date:07/14/99ISR Number: 3303992-7Report Type:Expedited (15-DaCompany Report #A0094748 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Health Lamictal Tablet PS ORAL SINGLE DOSE Hospitalization - Aspiration Professional ORAL Initial or Prolonged Electrocardiogram Qrs Gabapentin Capsule SS ORAL SINGLE DOSE Other Complex Prolonged ORAL Intentional Overdose Fluoxetine Lung Infiltration Hydrochloride Suicide Attempt (Formulation Tachypnoea Unknown) SS ORAL ORAL Ventricular Tachycardia Risperidone Vomiting (Formulation Unknown) SS ORAL ORAL Methylphenidate (Formulation Unknown) SS ORAL ORAL Thioridazine (Formulation Unknown) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 611 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ethanol (Formulation Unknown) SS ORAL ORAL Date:07/14/99ISR Number: 3304026-0Report Type:Expedited (15-DaCompany Report #A0094619 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Lamictal Tablet PS ORAL ORAL Initial or Prolonged Aspiration Professional Gabapentin SS ORAL SINGLE DOSE/ Other Electrocardiogram Qrs ORAL Complex Prolonged Fluoxetine Intentional Overdose Hydrochloride SS Lung Infiltration Risperidone SS Suicide Attempt Thioridazine SS Ventricular Tachycardia Methylphenidate SS Vomiting Ethanol SS Date:07/16/99ISR Number: 3305353-3Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Risperidone PS ORAL 6 MG PO QD Neutrophil Count Professional Olanzepine SS ORAL 12.5 MG PO Decreased QHS White Blood Cell Count Decreased Date:07/16/99ISR Number: 3305379-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Clozaril PS Novartis ORAL 200MG BID Initial or Prolonged Increased ORAL Blood Urea Increased Risperidone SS Renal Failure Acute Levothyroxine C Fluphenazine C Benztropine C Diphenhydramine C Aspirin C Docusate C Atorvastatin C Divalproex Sodium C Trazodone C Enalapril C Atenolol C Date:07/16/99ISR Number: 3305599-4Report Type:Expedited (15-DaCompany Report #JAUSA25236 Age:42 YR Gender: I/FU:F Outcome PT Required Amnesia Intervention to Aneurysm Prevent Permanent Blood Glucose Increased Impairment/Damage Blood Pressure Increased Chest Pain Circulatory Collapse Dizziness 22-Feb-2006 08:20 AM Page: 612 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyskinesia Electrocardiogram Qt Prolonged Report Source Product Role Manufacturer Route Dose Duration Embolism Consumer Risperdal (Tablet) Haematuria Health (Risperidone) PS ORAL 1 MG, 2 IN 1 Hearing Impaired Professional DAY (S), ORAL Heart Rate Irregular Pravachol C Hypoaesthesia Selenium C Liver Function Test Lotrisone C Abnormal Niacin C Pyrexia Vitamin E C Sperm Count Decreased Tylenol C Urinary Incontinence Ibruprofen C Visual Acuity Reduced Fish Oilo White Blood Cells Urine Concentrate C Positive Maalox C Date:07/16/99ISR Number: 3305613-6Report Type:Expedited (15-DaCompany Report #JRFUSA1999001103 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aphonia Consumer Risperdal (Tablet) Catatonia (Risperidone) PS ORAL 2 TABLE, 2 IN Depressed Level Of 1 DAY(S), Consciousness ORAL Disturbance In Attention Restoril (Temazepam) C Fear Medication Error Mental Impairment Paraparesis Date:07/16/99ISR Number: 3305614-8Report Type:Expedited (15-DaCompany Report #JACFRA1999000122 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperdal(2 Mg Initial or Prolonged Blood Creatine Health Tablet) (Riperidone) PS ORAL SEE IMAGE Phosphokinase Increased Professional Valium (Diazepam) C Chest Pain Imovane (Zopiclone) C Fall Lepticur (Tropaterine Hydrchloride) C Levothyrox (Levothyroxine Sodium) C Date:07/16/99ISR Number: 3305843-3Report Type:Expedited (15-DaCompany Report #JACFRA1999000139 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Self-Injury Foreign Haldol (5 Mg Tablet) Initial or Prolonged Necrosis Health (Haloperidol) PS ORAL MG, TOTAL, Pancreatitis Acute Professional ORAL Pancreatitis Relapsing Risperdal (2 Mg Tablet) (Risperidone) SS ORAL MG, TOTAL, ORAL Aspirine 22-Feb-2006 08:20 AM Page: 613 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Acetylsalicylic Acid) SS ORAL G, TOTAL, ORAL Solian (Amisulpride) SS ORAL G, TOTAL, ORAL Augmentin (Augmentin Injection) SS INTRAVENOUS G, TOTAL, IV Athymil C Temesta C Rohypnol C Valium C Terican C Equanil C Tranxene C Mopral C Date:07/19/99ISR Number: 3306605-3Report Type:Expedited (15-DaCompany Report #JRFUSA1999001195 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Health Risperdal (1 Mg Initial or Prolonged Coma Professional Tablet) Required Pyrexia (Risperidone) PS ORAL 0.75 MG, Intervention to Urinary Tract Infection DAILY, ORAL Prevent Permanent Vasotec C Impairment/Damage Prednisone C Synthroid C Lasix C Normodyne C Date:07/19/99ISR Number: 3306608-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999000355 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL MG, DAILY, ORAL Lopirin C Lasix C Date:07/19/99ISR Number: 3306610-7Report Type:Expedited (15-DaCompany Report #JACFRA1999000182 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Risperdal Initial or Prolonged Health (Unspecified) Professional (Risperidone) PS ORAL MG, DAILY, ORAL Antivirals For Systemic Use C Date:07/19/99ISR Number: 3306819-2Report Type:Expedited (15-DaCompany Report #1191245A Age:51 YR Gender:Female I/FU:F Outcome PT Death Analgesic Drug Level Above Therapeutic 22-Feb-2006 08:20 AM Page: 614 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Completed Suicide Drug Level Above Therapeutic Report Source Product Role Manufacturer Route Dose Duration Literature Unknown Health Acetaminophen Professional Product PS ORAL UNKNOWN DOSE, PO 48 HR Aspirin SS ORAL UNKNOWN DOSE, PO 48 HR Verapamil SS Valproic Acid SS Risperidone SS Alprazolam SS Venlafaxine SS Olanzapine SS Ibuprofen SS Date:07/19/99ISR Number: 3307044-1Report Type:Expedited (15-DaCompany Report #JACGER1999000174 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Risperdal Initial or Prolonged Electrocardiogram Qt Health (Unspecified Tablet) Required Prolonged Professional ( Risperidone) PS ORAL 150 MG 1 Intervention to Intentional Overdose IN 1 TIME(S) Prevent Permanent Suicide Attempt ORAL/3 MG Impairment/Damage Torsade De Pointes DAILY ORAL Tagonis (Paroxetine Hydrochloride) SS ORAL 400 MG 1 IN 1 TIME(S) ORAL Date:07/19/99ISR Number: 3307342-1Report Type:Expedited (15-DaCompany Report #1191226A Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Unknown Tylenol Drug Level Above Health Product PS ORAL PO, 4 DAYS Therapeutic Professional PRIOR TO COMING TOHOSP Risperidone SS ORAL PO Date:07/20/99ISR Number: 3306768-XReport Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Risperdol 1mg (1mg O PS 1T MG Q AM, 1 1/2 Q HS Depakote 250mg SS BID Date:07/20/99ISR Number: 3306772-1Report Type:Direct Company Report # Age:17 YR Gender:Male I/FU:I Outcome PT Other Hypoaesthesia Sedation 22-Feb-2006 08:20 AM Page: 615 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sensation Of Heaviness Report Source Product Role Manufacturer Route Dose Duration Resperdol 1 G PS ORAL 1MG PO BID Date:07/21/99ISR Number: 3308150-8Report Type:Expedited (15-DaCompany Report #JRFBEL1999000608 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Renal Failure Acute Foreign Risperdal Hospitalization - Suicide Attempt Health (Unspecified) Initial or Prolonged Professional (Risperidone) PS ORAL 1.5 MG, 1 IN 1 DAY(S), ORAL Digoxine C Prozac C Date:07/22/99ISR Number: 3309949-4Report Type:Direct Company Report # Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Below Deapakote PS Abbott ORAL 500-250-500 / Required Therapeutic TID / ORAL Intervention to Liver Function Test Resperal SS Jansen ORAL 2MG / BID / Prevent Permanent Abnormal ORAL Impairment/Damage Mania Dexedrine C Neurontin C Date:07/22/99ISR Number: 3309951-2Report Type:Direct Company Report # Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Percentage Risperidone PS ORAL 6 MG PO QD Decreased Olanzepine SS 12.5 MG PO Treatment Noncompliance QHS White Blood Cell Count Decreased Date:07/22/99ISR Number: 3309959-7Report Type:Direct Company Report # Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Heart Rate Increased Risperidone PS ORAL 4 MG ONCE A Disability Libido Decreased DAY Congenital Anomaly Weight Increased Sex Pills C Other Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:20 AM Page: 616 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/22/99ISR Number: 3309978-0Report Type:Direct Company Report # Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Rigidity Risperidone PS 2MG BID Sertraline SS 50MG QD Lorazepam C Valproic Acid C Date:07/23/99ISR Number: 3310009-7Report Type:Expedited (15-DaCompany Report #JRFBEL1999000541 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Haloperidol Initial or Prolonged Drug Eruption Literature (Unspecified) Dyskinesia Health (Haloperidol) PS MG, DAILY, Hallucination, Auditory Professional UNKNOWN 9 DAY Irritability Risperidone Malaise (Unspecified) Restlessness (Risperidone) SS ORAL MG, DAILY, ORAL Bromperidol (Unspecified) (Bromperidol) SS MG, DAILY Haloperidol (Unspecified) (Haloperidol) SS MD, DAILY, UNKNOWN Sulpiride (Sulpiride) SS MG, DAILY Risperidone (Unspecified) (Risperisone) SS ORAL MG, DAILY, ORAL Sulpiride (Sulpiride) SS MG, DAILY Biperiden (Biperiden) C Promethazine (Promethazine) C Etizolam (Etizolam) C Periciazine (Periciazine) C Date:07/26/99ISR Number: 3311208-0Report Type:Expedited (15-DaCompany Report #JRFUSA1999001432 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Literature Risperdal Hospitalization - Distress Syndrome Health (Unspecified) Initial or Prolonged Blood Ph Increased Professional (Risperidone) PS ORAL ORAL Required Coma Aspirin Intervention to Completed Suicide (Acetylsalicylic Prevent Permanent Intentional Overdose Acid) SS ORAL ORAL Impairment/Damage Loss Of Consciousness Acetaminophen, Multi-Organ Failure (Paracetamol) SS ORAL ORAL Pco2 Decreased Verapamil Po2 Increased (Verapamil) SS ORAL ORAL Valproic Acid (Valproic Acid) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 617 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Alprazolam (Alprazolam) SS ORAL ORAL Venlafaxine (Venlafaxine) SS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Ibuprofen (Ibuprofen) SS ORAL ORAL Date:07/27/99ISR Number: 3313893-6Report Type:Direct Company Report # Age:15.6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Health Risperadol 1.5mg Galactorrhoea Professional Bid, Decreased 1mg Bid, Decreased 0.5mg Bid PS 1.5MG BID, DECREASES 1MG BID, DECREASED 0.5MG BID Wellbutrin 75mg Q Am SS ORAL 75MG PO Q AM Date:07/28/99ISR Number: 3312764-9Report Type:Expedited (15-DaCompany Report #210470 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastric Ulcer Foreign Valium (Diazepam) 5 Initial or Prolonged Overdose Other Mg PS ORAL ORAL Suicide Attempt Aspirine (Aspirin) 500 Mg SS ORAL ORAL Rohypnol (Flunitrazepam) SS ORAL ORAL Temesta (Lorazepam) 1 Mg SS ORAL ORAL Solian (Amisulpride) 200 Mg SS ORAL ORAL Haldol (Haloperidol) 5 Mg SS ORAL ORAL Athymil (Mianserin Hydrochloride) 60 Mg SS ORAL ORAL Risperdal (Risperidone) 2 Mg SS ORAL ORAL Tercian (Cyamemazine) 100 Mg SS ORAL ORAL Equanil (Meprobamate) 400 Mg SS ORAL ORAL Tranxene (Clorazepate Dipotassium) 10 Mg SS ORAL ORAL Date:07/28/99ISR Number: 3312806-0Report Type:Expedited (15-DaCompany Report #8-99196-162A Age:22 YR Gender:Female I/FU:I Outcome PT Hospitalization - Body Temperature Initial or Prolonged Decreased Hallucination 22-Feb-2006 08:20 AM Page: 618 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Overdose Sedation Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Efexor Tablets Health (Venlafaxine Professional Hydrochloride) PS ORAL 2025MG OVERDOSE AMOUNT ORAL Risperidone SS ORAL 45MG OVERDOSE AMOUNT ORAL Zopiclone Tablets SS ORAL 52.5MG OVERDOSE AMOUNT ORAL Date:07/28/99ISR Number: 3312946-6Report Type:Expedited (15-DaCompany Report #JRFUSA1999001379 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoventilation Health Risperdal (1mg Initial or Prolonged Muscular Weakness Professional Tablet) Pco2 Increased (Risperidone) PS ORAL 0.5MG, 2 IN 1 Pneumonia DAY (S) ORAL Po2 Decreased Celexa C Urinary Retention Date:07/28/99ISR Number: 3312947-8Report Type:Expedited (15-DaCompany Report #JRFUSA1999001315 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aneurysm Consumer Risperdal (2mg Tablet) (Risperidone) PS ORAL 2MG, 2 IN 1 DAY (S) ORAL Zoloft C Lescol C Prilosec C Date:07/29/99ISR Number: 3313914-0Report Type:Expedited (15-DaCompany Report #JRFUSA1999001553 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Health Risperdal (Tablet) Initial or Prolonged Increased Professional (Risperidone) PS ORAL 3 MG, 2 IN 1 Bradycardia DAY(S), ORAL Renal Impairment Date:07/29/99ISR Number: 3314134-6Report Type:Expedited (15-DaCompany Report #9843322 Age: Gender:Male I/FU:F Outcome PT Hospitalization - Aggression Initial or Prolonged Agitation Required Anger Intervention to Dermatitis Prevent Permanent Drug Interaction Impairment/Damage Hypersomnia Nervousness 22-Feb-2006 08:20 AM Page: 619 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Transient Ischaemic Attack Report Source Product Role Manufacturer Route Dose Duration Consumer Zoloft Tablets PS ORAL 25.00 MG TOTAL:DAILY:O RAL Aricept SS Xanax SS Risperidol SS ORAL 1.50 MG TOTAL:BID:ORA L Ben Gay C Zyprexa C Cardizem Cd C Gingko C Unspecified Antioxidants C Tylenol C St. John'S Wort C Date:07/29/99ISR Number: 3314221-2Report Type:Expedited (15-DaCompany Report #JAOCAN1999000223 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Delirium Foreign Risperdal Diabetes Mellitus Health (Unspecified) Inadequate Control Professional (Risperidone) PS ORAL 4MG DAILY Extrapyramidal Disorder ORAL, 5MG Heart Rate Abnormal DAILY ORAL Labile Blood Pressure Lithium C Muscle Rigidity Cogentin C Neuroleptic Malignant Insulin C Syndrome Antihypertensives C Pyrexia White Blood Cell Count Increased Date:07/30/99ISR Number: 3315350-XReport Type:Expedited (15-DaCompany Report #JRFBEL1999000613 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastric Ulcer Foreign Risperidone (Tablet) Initial or Prolonged Ileus Paralytic Health (Risperidone) PS ORAL SEE IMAGE Professional Haloperidol C Biperiden Hydrochloride C Zotepine C Esberiven C Levomepromazine C Sennosides C Magnesium Oxide C Hizulen-S C Teprenone C Aluminium Hydroxide C Trimebutine Maleate C Famotidine C Glucose-Acetated Ringer'S Solution C Dinoprost C 22-Feb-2006 08:20 AM Page: 620 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Carbamazepine C Bromvalerylurea C Amobarbital C Minocycline Hydrochloride C Chlorpromazine Hydrochloride C Estazolam C Cisapride C Soldem C Panthenol C Haloperidol C Biperiden Lactate C Fosfomycin Sodium C Crude Drugs C Erythromycin Ethylsuccinate C Gentamicin Sucinate C Date:07/30/99ISR Number: 3315352-3Report Type:Expedited (15-DaCompany Report #JRFUSA1999001554 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Risperdal (Tablet) Porphyria Professional (Risperidone) PS ORAL ORAL Date:07/30/99ISR Number: 3315552-2Report Type:Direct Company Report # Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Risperdal 1mg Once Dystonia Bid PS 1MG BID Prozac C Date:07/30/99ISR Number: 3316051-4Report Type:Expedited (15-DaCompany Report #8-99204-023A Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Health Ativan Tablets PS ORAL 1 MG THREE Increased Professional TIMES DAILY Blood Glucose Increased ORAL Blood Urea Increased Risperdal Body Temperature (Risperidone) Increased Tablets SS ORAL 1 MG TWICE Coma DAILY Medication Error INCREASED ON Schizophrenia 10-JUL-99 TO Sedation 2 MG TWICE Zoloft (Sertraline) SS ORAL 50 MG ONCE DAILY ORAL Date:08/02/99ISR Number: 3316124-6Report Type:Expedited (15-DaCompany Report #99F--10685 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Confusional State Foreign Initial or Prolonged Delirium Health 22-Feb-2006 08:20 AM Page: 621 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Tegretol Tablet (Carbamazepine) PS ORAL 200 MG, DAILY, ORAL Cortancyl Tablet (Prednisone) SS ORAL 5 MG, DAILY, ORAL Solu-Medrol Solution Dor Injection (Methylprednisolone Sodium Succinate) SS Endoxan Solution For Injection (Cyclophosphamide) SS INTRAVENOUS INTRAVENOUS Levothyrox Tablet (Levothyroxine Sodium) SS ORAL ORAL 5 MON Depakine Tablet (Valproate Sodium) SS ORAL ORAL 13 MON Mopral Tablet (Omeprazole) SS ORAL ORAL Risperdal Tablet (Risperidone) SS ORAL 4 GMG DAILY ORAL Tranxene Tablet C Date:08/02/99ISR Number: 3316297-5Report Type:Expedited (15-DaCompany Report #JACGER1999000126 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal Initial or Prolonged Health (Unspecified Tablet) Professional (Risperidone) PS ORAL 6MG DAILY ORAL Leponex (Clozapine) SS 12.5MG DAILY Diazepam C Date:08/02/99ISR Number: 3316299-9Report Type:Expedited (15-DaCompany Report #JRFUSA1999001552 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Csf Test Abnormal Health Risperdal (3mg Initial or Prolonged Hypertension Professional Tablet) Mental Disorder (Risperidone) PS ORAL 3MG DAILY Pyrexia ORAL Tachycardia Date:08/02/99ISR Number: 3317744-5Report Type:Direct Company Report # Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Movement Disorder Risperdal - 4 Mgm Restlessness Per Day (Janssen ) PS Janssen ORAL Diatropan SS Bentyl SS 22-Feb-2006 08:20 AM Page: 622 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/05/99ISR Number: 3318098-0Report Type:Direct Company Report # Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Risperidone PS Initial or Prolonged Drooling Dystonia Date:08/06/99ISR Number: 3320324-9Report Type:Expedited (15-DaCompany Report #7398564 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Health Abbott-Depakote PS Abbott ORAL 500.000 MG PO Hospitalization - Abscess Professional BID Initial or Prolonged Ascites Risperdal SS Aspartate Klonopin C Aminotransferase Cipro C Increased Dilantin C Blood Alkaline Synthroid C Phosphatase Increased Ddavp C Leukocytosis Peri-Colace C Pancreatitis Ativan C Pleural Effusion Sepsis Staphylococcal Infection Vomiting Date:08/09/99ISR Number: 3321504-9Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Risperadol 1 Mg Po Initial or Prolonged Dysphagia Professional Qd PS ORAL 1MG PO UD; Dyspnoea OVER 1 YEAR Hypersensitivity Hypertension Laryngeal Oedema Oesophageal Obstruction Panic Reaction Pharyngeal Oedema Sciatica Spondylolisthesis Acquired Stridor Date:08/09/99ISR Number: 3321734-6Report Type:Expedited (15-DaCompany Report #JRFUSA1999001589 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Consumer Risperdal (Tablet) Initial or Prolonged Condition Aggravated (Risperidone) PS ORAL 4 MG, 1 IN 1 Muscle Twitching DAY (S), ORAL Tardive Dyskinesia 22-Feb-2006 08:20 AM Page: 623 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/99ISR Number: 3321738-3Report Type:Expedited (15-DaCompany Report #JRFUSA1999000617 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hodgkin'S Disease Health Risperdal (Tablet) Hospitalization - Liver Function Test Professional (Risperidone) PS ORAL 3.5 MG, Initial or Prolonged Abnormal DAILY, ORAL Required Cytoxan Intervention to (Cyclophosphamide) SS INTRAVENOUS 120 MG/KG, IV Prevent Permanent Acyclovir C Impairment/Damage Date:08/09/99ISR Number: 3321741-3Report Type:Expedited (15-DaCompany Report #JACGER1999000313 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Filariasis Foreign Risperdal (6 Mg Initial or Prolonged Insomnia Health Tablet) Lymphoedema Professional (Risperidone) PS ORAL 6 MG, 1 IN 1 Oedema Peripheral DAY (S), ORAL Neurocil (Levomepromazine Maleate) SS ORAL 25 MG, 1 IN 1 DAY (S), ORAL Date:08/09/99ISR Number: 3321746-2Report Type:Expedited (15-DaCompany Report #JAKYO43708 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bundle Branch Block Right Foreign Risperiodone Subarachnoid Haemorrhage Health (Tablet) Professional (Risperidone) PS ORAL MG, DAILY, ORAL Pimozide C Cisapride C Lithium C Flunitrazepam C Biperiden Hydrochloride C Flurazepam C Levomepromazine Maleate C Clarithromycin C Sultopride C Sennoside C Marzulene C Brotizolam C Date:08/09/99ISR Number: 3321752-8Report Type:Expedited (15-DaCompany Report #JACGER1999000321 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Risperdal Initial or Prolonged Leukopenia Health (Unspecified Tablet) Neutropenia Professional (Risperidone) PS ORAL 7 MG, DIALY, Company ORAL Representative 22-Feb-2006 08:20 AM Page: 624 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/10/99ISR Number: 3322420-9Report Type:Expedited (15-DaCompany Report #9933830 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Health Zoloft Tablets PS ORAL 50.00 MG Increased Professional TOTAL; Blood Glucose Increased DAILY;ORAL Blood Urea Increased Risperdal SS 2.00 MG Body Temperature TOTAL;BID Increased Lorazepam SS ORAL 3.00 MG Cardio-Respiratory Arrest TOTAL;TID;ORA Coma L Pulse Absent Sedation Date:08/11/99ISR Number: 3323967-1Report Type:Expedited (15-DaCompany Report #9933620 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Sinequan Capsules PS ORAL 400.00 MG Initial or Prolonged Suicide Attempt Professional TOTAL:DAILY Risperdal SS ORAL 2.00 MG TOTAL:DAILY Remeron C Date:08/11/99ISR Number: 3324466-3Report Type:Expedited (15-DaCompany Report #JRFBEL1999000407 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Infarction Foreign Risperidone Hospitalization - Cerebrovascular Spasm Health (Unspecified Tablet) Initial or Prolonged Cholecystitis Professional (Risperidone) PS ORAL MG, DAILY, Depressed Level Of ORAL Consciousness Alprazolam C Fall Estazolam C Jaundice Biperiden C Subdural Haematoma Chlorpromazine Hydrochloride C Date:08/13/99ISR Number: 3324364-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Distension Zyprexa 54mg PS ORAL PO QHS Weight Increased Risperdal 1mg SS ORAL PO TID Effexor C Depakote C Neurontin C Date:08/13/99ISR Number: 3324396-7Report Type:Direct Company Report # Age:20 YR Gender:Female I/FU:I Outcome PT Hospitalization - Dyskinesia Initial or Prolonged Macroglossia Speech Disorder Tardive Dyskinesia Tongue Discolouration 22-Feb-2006 08:20 AM Page: 625 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tongue Oedema Report Source Product Role Manufacturer Route Dose Duration Health Risperdal PS ORAL 3 MG PO BID 2 DAY Professional Date:08/16/99ISR Number: 3326503-9Report Type:Direct Company Report # Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Haldol 5mg Injection PS 1MG/M Q 3-4 Initial or Prolonged Condition Aggravated Professional HRS PRN 2 DAY Required Delirium Risperdal 1mg Tab SS ORAL 1MG 1 PO QHS 2 DAY Intervention to Hallucination Prevent Permanent Impairment/Damage Date:08/16/99ISR Number: 3326649-5Report Type:Expedited (15-DaCompany Report #JRFUSA1999001759 Age:13 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Exposure Consumer Risperdal (1 Mg Required Condition Aggravated Tablets) Intervention to Cyanosis (Risperidone) PS ORAL 1 MG, 1 IN 1 Prevent Permanent Injury Asphyxiation TIME(S), ORAL Impairment/Damage Medication Error Sedation Sleep Apnoea Syndrome Date:08/16/99ISR Number: 3326844-5Report Type:Expedited (15-DaCompany Report #JRFUSA1999000866 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Risperdal Hospitalization - Hepatic Failure Professional (Unspecified) Initial or Prolonged Hypotension (Risperidone) PS ORAL ORAL Required Muscle Rigidity Tranylcypromine Intervention to Neuroleptic Malignant (Tranylcypromine) SS ORAL ORAL Prevent Permanent Syndrome Fluoxetine Impairment/Damage Pyrexia (Fluoxetine) SS ORAL ORAL Renal Failure Date:08/17/99ISR Number: 3329432-XReport Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hyperglycaemia Health Risperidone 3mg Intervention to Professional (Janssen) PS Janssen ORAL 3MG BID PO Prevent Permanent Depakote 125mg + Impairment/Damage 500mg (Abbott) SS Abbott 1125 MG HS Remeron C Mylanta C Mom C Acetaminophen C Diphenhydramine C Propranolol C 22-Feb-2006 08:20 AM Page: 626 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/19/99ISR Number: 3330235-0Report Type:Expedited (15-DaCompany Report #JAKYO31766 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Foreign Risperidone (Tablet) Drug Interaction Literature (Risperidone) PS ORAL 2 MG, DAILY, Drug Level Below Health ORAL; 4 MG, Therapeutic Professional DAILY, ORAL; Loss Of Consciousness 8 MG, DAILY ORAL; 10 MG, Zonisamide(Tablet) (Zonisamide) SS ORAL 300 MG, DAILY, ORAL Amantadine C Levomepromazine C Sultopride C Chlorpromazine C Promethazine C Famotidine C Date:08/19/99ISR Number: 3330257-XReport Type:Expedited (15-DaCompany Report #9934882 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Macular Degeneration Foreign Zoloft Tablets PS ORAL 50.00 MG Health TOTAL:DAILY:O Professional RAL Company Risperadone SS ORAL 4.00 MG Representative TOTAL:ORAL Benztropine C Date:08/20/99ISR Number: 3331201-1Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Risperdal (Janssen) PS Janssen ORAL PO Intervention to Dyskinesia Prozaac C Prevent Permanent Speech Disorder Impairment/Damage Tongue Oedema Date:08/23/99ISR Number: 3331937-2Report Type:Expedited (15-DaCompany Report #JACGER1999000404 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Risperdal Initial or Prolonged Health (Unspecified Tablet) Required Professional (Risperidone) PS ORAL 2MG DAILY Intervention to ORAL Prevent Permanent Atendol C Impairment/Damage Date:08/23/99ISR Number: 3331945-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999000661 Age: Gender:Unknown I/FU:I Outcome PT Death Cardiac Arrest Cardiac Fibrillation Coma 22-Feb-2006 08:20 AM Page: 627 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Level Below Therapeutic Medication Error Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS MG DAILY Date:08/23/99ISR Number: 3331952-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999000739 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal (Tablet) Initial or Prolonged Phosphokinase Increased Health (Risperidone) PS ORAL MG DAILY ORAL Required Dialysis Professional Intervention to Intra-Abdominal Prevent Permanent Haemorrhage Impairment/Damage Neuroleptic Malignant Syndrome Pyrexia Renal Failure Shock Date:08/23/99ISR Number: 3331955-4Report Type:Expedited (15-DaCompany Report #JRFBEL1999000752 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Foreign Risperdal (2mg Initial or Prolonged Bradycardia Health Tablet) Fatigue Professional (Risperidone) PS ORAL MG DAILY ORAL Syncope Date:08/23/99ISR Number: 3331985-2Report Type:Expedited (15-DaCompany Report #JRFUSA1999001892 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Risperdal (2 Mg Neutropenia Professional Tablet) (Risperidone) PS ORAL 2 MG 2 IN 1 DAY(S) ORAL Neutrontin C Date:08/23/99ISR Number: 3331987-6Report Type:Expedited (15-DaCompany Report #JRFUSA1999001876 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dystonia Consumer Risperdal (1 Mg Lethargy Tablet) Muscular Weakness (Risperidone) PS ORAL 1 MG 1 IN Musculoskeletal Stiffness 1 DAY(S)/2 IN Sedation 1 DAY Tremor ORAL Trazodone C Zoloft C Antihypertensives C Synthroid C Vitam. B12 C Premarin C 22-Feb-2006 08:20 AM Page: 628 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/99ISR Number: 3332539-4Report Type:Expedited (15-DaCompany Report #JAUK43858 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchospasm Foreign Risperdal Hospitalization - Cardiomegaly Health (Unspecified) Initial or Prolonged Cardiomyopathy Professional (Risperidone) PS ORAL ORAL Supraventricular Verapamil SS Tachycardia Date:08/24/99ISR Number: 3333041-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drooling Risperidone PS 2MG Q HS Intervention to Fall Prevent Permanent Immobile Impairment/Damage Date:08/24/99ISR Number: 3333058-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyskinesia Resperidone 0.5 Mg PS 0.5MG Q 6S ; Intervention to Muscle Rigidity CHRONIC Prevent Permanent Impairment/Damage Date:08/25/99ISR Number: 3333968-5Report Type:Direct Company Report # Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Risperidone PS 3MG BID; 6MG Blood Creatine 7/26 Phosphokinase Increased Fluoxetine SS 40MG Q AM Cellulitis Amoxicillin C Confusional State Diarrhoea Difficulty In Walking Dysarthria Dystonia Flat Affect Joint Stiffness Muscle Rigidity Myoglobinuria Nasopharyngitis Posture Abnormal Pyrexia Restlessness Speech Disorder Tachycardia Tremor 22-Feb-2006 08:20 AM Page: 629 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/99ISR Number: 3334273-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Health Risperdal PS ORAL 2MG PO BID 61 WKN Required Professional Trilafon SS ORAL 4MG PO BID 15 DAY Intervention to Prevent Permanent Impairment/Damage Date:08/25/99ISR Number: 3334432-XReport Type:Expedited (15-DaCompany Report #JRFUSA1999001909 Age:94 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Burns Second Degree Health Risperdal (Tablet) Hospitalization - Hyperpyrexia Professional (Risperidone) PS ORAL 0.5 MG, 2 IN Initial or Prolonged Neuroleptic Malignant 1 DAY(S), Required Syndrome ORAL Intervention to Respiratory Distress Vasotec C Prevent Permanent Lasix C Impairment/Damage Potassium C Date:08/26/99ISR Number: 3334917-6Report Type:Expedited (15-DaCompany Report #10084556 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Liver Function Test Health Cytoxan PS INTRAVENOUS 120 MG/KG, Hospitalization - Abnormal Professional 1/1 CYCLE IV Initial or Prolonged Risperdal Required (Risperidone) SS ORAL 3.5 Intervention to MILLIGRAMS, Prevent Permanent 1/1 DAY ORAL Impairment/Damage Acyclovir C Date:08/26/99ISR Number: 3335394-1Report Type:Expedited (15-DaCompany Report #JACGBR1999000159 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Foreign Risperdal (2 Mg Initial or Prolonged Chest X-Ray Abnormal Health Tablet) Crepitations Professional (Risperidone) PS ORAL 2 MG 2 IN Dyspnoea 1 DAY(S) Myocarditis ORAL Valproate C Mirtazapine C Zimovane C Ibuprofen C Clarithromycin C Date:08/27/99ISR Number: 3336455-3Report Type:Expedited (15-DaCompany Report #99F--10777 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Bullous Foreign Anafranil Tablet Initial or Prolonged Leukocytoclastic Health (Clomipramine Vasculitis Professional Hydrochloride) PS ORAL 75 MG, DAILY, Urticaria Other ORAL Dipiperon Tablet 22-Feb-2006 08:20 AM Page: 630 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Pipamperone Hydrochloride) SS ORAL 160 MG, DAILY, ORAL Theralene Solution (Alimemazine Tartrate) SS ORAL 1.5 MG, DAILY, ORAL Lysanxia Tablet (Prazepam) SS ORAL 80 MG, DAILY, ORAL Lepticur Tablet (Tropatepine Hydrochloride) SS ORAL ORAL Risperdal (Risperidone) SS ORAL ORAL Date:08/27/99ISR Number: 3336896-4Report Type:Expedited (15-DaCompany Report #10084556 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Liver Function Test Health Cytoxan PS ORAL 120 MG/KG, Hospitalization - Abnormal Professional 1/1 CYCLE Initial or Prolonged Risperdal Required (Risperidone) SS ORAL 3.5 MG, 1/1, Intervention to DAY ORAL 5 YR Prevent Permanent Acyclovir C Impairment/Damage Date:08/30/99ISR Number: 3337362-2Report Type:Expedited (15-DaCompany Report #9936071 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Zoloft Tablets PS ORAL 25.00 MG Initial or Prolonged Biliary Colic Health TOTAL; Cholecystectomy Professional DAILY; ORAL Lymphocytosis Company Risperidone SS ORAL 2.00 MG Metabolic Disorder Representative TOTAL; BID; Red Blood Cell ORAL Sedimentation Rate Increased Rouleaux Formation Date:08/30/99ISR Number: 3337524-4Report Type:Expedited (15-DaCompany Report #JRFUSA1999001888 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematocrit Decreased Health Risperdal (1 Mg Haemoglobin Abnormal Professional Tablet) Hepatic Cirrhosis (Risperidone) PS ORAL 1 MG, DAILY, Liver Function Test ORAL Abnormal Depakote (Valproate Platelet Count Abnormal Semidosium) SS ORAL 675 MG, Red Blood Cell DAILY, ORAL Abnormality Clonazepam Splenomegaly (Clonazepam) SS ORAL ORAL Weight Decreased Synthroid C White Blood Cell Disorder Benadryl C Colace C 22-Feb-2006 08:20 AM Page: 631 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/99ISR Number: 3337525-6Report Type:Expedited (15-DaCompany Report #JRFBEL1999000261 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laryngitis Foreign Risperidone (Tablet) Nasopharyngitis Health (Risperidone) PS ORAL MG, DAILY, Pyrexia Professional ORAL Biperiden Hydrochloride C Flunitrazepam C Sulpiride C Nitrazepam C Vegetamin B C Triazolam C Date:08/30/99ISR Number: 3337532-3Report Type:Expedited (15-DaCompany Report #JRFBEL1999000661 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Risperdal (3 Mg Cardiac Fibrillation Health Tablet) Coma Professional (Risperidone) PS ORAL MG, DAILY, Medication Error ORAL Toxicologic Test Abnormal Date:08/30/99ISR Number: 3337541-4Report Type:Expedited (15-DaCompany Report #JRFUSA1999001589 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aplastic Anaemia Health Risperdal (Tablet) Initial or Prolonged Epistaxis Professional (Risperidone) PS ORAL 3 MG, 1 IN 1 Haematocrit Decreased DAY(S), ORAL Haemoglobin Decreased (SEE IMAGE) Leukopenia Muscle Twitching Platelet Count Decreased Tardive Dyskinesia Thrombocytopenia Date:08/30/99ISR Number: 3337545-1Report Type:Expedited (15-DaCompany Report #JRFUSA1999000787 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Hypoxia Health Risperdal (Tablet) Initial or Prolonged Collapse Of Lung Professional (Risperidone) PS ORAL ORAL Pulmonary Oedema Local Anaesthetic (Local-Anaesthetics) SS Date:08/30/99ISR Number: 3337550-5Report Type:Expedited (15-DaCompany Report #JRFBEL1999000914 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Candidiasis Foreign Risperdal (Tablet) Initial or Prolonged Dysphagia Health (Risperidone) PS ORAL MG, DAILY, Required Leukopenia Professional ORAL Intervention to Pyrexia Neozine C Prevent Permanent Tonsillitis Artane C Impairment/Damage Fenergan C 22-Feb-2006 08:20 AM Page: 632 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/99ISR Number: 3339389-3Report Type:Expedited (15-DaCompany Report #98HQ-10020 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Carbamazepine Initial or Prolonged Drug Interaction Health Unknown Drug Level Below Professional (Carbamazepine) PS 600 MG, Therapeutic DAILY, Risperidone (Risperidone) SS 4 MG DAILY, Date:08/30/99ISR Number: 3339775-1Report Type:Expedited (15-DaCompany Report #JAOCAN199000274 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Haldol (1 Mg Tablet) Initial or Prolonged Fear Study (Haloperidol) PS ORAL 3 MG, DAILY, Hallucination Health ORAL Hallucination, Auditory Professional Risperdal (1 Mg Schizophrenia Tablet) Suicidal Ideation (Risperidone) SS ORAL 3 MG, DAILY, ORAL Date:08/31/99ISR Number: 3337231-8Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Akinesia Risperidone PS ORAL 6MG HS ORAL Hospitalization - Aphasia Lithium SS ORAL 300MG BID Initial or Prolonged Catatonia ORAL Coma Levothyroxine C Confusional State Dysphagia Extrapyramidal Disorder Joint Stiffness Labile Blood Pressure Laryngospasm Leukocytosis Liver Function Test Abnormal Muscle Rigidity Neuroleptic Malignant Syndrome Parkinsonism Proteinuria Pulmonary Congestion Pyrexia Speech Disorder White Blood Cell Count Increased Date:08/31/99ISR Number: 3337236-7Report Type:Direct Company Report # Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Tenderness Risperidone PS ORAL 0.5MG AM / Galactorrhoea 1.5MG HS / ORAL 22-Feb-2006 08:20 AM Page: 633 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/01/99ISR Number: 3339058-XReport Type:Expedited (15-DaCompany Report #JACFRA1999000270 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Foreign Risperdal (1 Mg Health Tablet) Professional (Risperidone) PS ORAL 0.5 MG, DAILY, ORAL Packed Blood Cells (Blood Cells, Packed Human) SS INTRAVENOUS 1 OTHER, DAILY, IV INF Efferalgan C Duphalac C Date:09/02/99ISR Number: 3339668-XReport Type:Direct Company Report # Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dystonia Risperidone PS Hospitalization - Muscle Rigidity Carbamazepine C Initial or Prolonged Neuroleptic Malignant Hydrocortisone C Required Syndrome Levothyroxine Sodium C Intervention to Olanzapine C Prevent Permanent Sertraline C Impairment/Damage Lorazepam C Docusate Na C Guaifensin Dm C Acetaminophen C Warfarin (Coumadin) C Betaxolol C Date:09/02/99ISR Number: 3339680-0Report Type:Direct Company Report # Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tic Risperidone PS ORAL 0.5MG BID ORAL Depakote C Date:09/02/99ISR Number: 3339715-5Report Type:Direct Company Report # Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholestasis Risperidone PS Initial or Prolonged Lorazepam C Required Hydrochlorothiazide C Intervention to Buspirone C Prevent Permanent Impairment/Damage Date:09/02/99ISR Number: 3339717-9Report Type:Direct Company Report # Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Risperidone PS ORAL 1MG BID Hospitalization - Prolonged ORALLY Initial or Prolonged Hydroxyzine C 22-Feb-2006 08:20 AM Page: 634 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sertraline C Trazodone C Date:09/02/99ISR Number: 3339938-5Report Type:Expedited (15-DaCompany Report #JRFBEL1999000430 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Risperdal Initial or Prolonged Condition Aggravated Health (Unspecified) Depression Professional (Risperidone) PS SEE IMAGE Infection Olanzapine Medication Error (Olanzapine) SS SEE IMAGE Psychotic Disorder Paroxetine C Restlessness Benztropine C Tremor Clonazepam C Paraxetine C Benztropine C Clonazepam C Flucytosine C Dideoxyinosine C D4t C Saquinavir C Ritonavir C Date:09/07/99ISR Number: 3342422-6Report Type:Expedited (15-DaCompany Report #JAKY043708 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bundle Branch Block Right Foreign Risperidone (Tablet) Hospitalization - Depressed Level Of Health (Risperidone) PS ORAL MG DAILY ORAL Initial or Prolonged Consciousness Professional Pimozide C Required Fall Cisapride C Intervention to Subarachnoid Haemorrhage Lithium C Prevent Permanent Flunitrazepam C Impairment/Damage Biperiden Hydrochloride C Flurazepam Hydrochloride C Levomepromazine Maleate C Clarithromnycin C Sultopride Hydrochloride C Sennoside C Marzulene C Brotizolam C Kakkon-To-Ka-Senkyu- Sin C Date:09/07/99ISR Number: 3342429-9Report Type:Expedited (15-DaCompany Report #JACGER1999000313 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthropod Bite Foreign Risperdal (6mg Initial or Prolonged Filariasis Health Tablet) Lymphoedema Professional (Risperidone) PS ORAL MG DAILY ORAL Oedema Peripheral Neurocil (Levomepromazine 22-Feb-2006 08:20 AM Page: 635 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maleate) SS ORAL 25MG 1 IN 1 DAY (S) ORAL Date:09/07/99ISR Number: 3344489-8Report Type:Expedited (15-DaCompany Report #JRFUSA1999002230 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Risperdal (Tablet) Convulsion Professional (Risperidone) PS ORAL 0.25 MG, 1 IN 1 DAY(S) Tegretol (Carbamazepine) SS ORAL Date:09/07/99ISR Number: 3344494-1Report Type:Expedited (15-DaCompany Report #JACRA1999000182 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Distension Foreign Risperdal Intervention to Ileus Paralytic Health (Unspecified) Prevent Permanent Professional (Risperidone) PS ORAL MG, DAILY Impairment/Damage Zerit (Stavudine) C Epivir (Lamivudine) C Viramune (Nevirapine) C Date:09/07/99ISR Number: 3344499-0Report Type:Expedited (15-DaCompany Report #JRFBEL1999000739 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Risperdal (Tablet) Initial or Prolonged Blood Creatine Health (Risperidone) PS ORAL MG, DAILY Required Phosphokinase Increased Professional Biperiden Intervention to Dehydration Hydrochloride Prevent Permanent Fall (Biperiden Impairment/Damage Haematoma Hydrochloride) SS ORAL MG, DAILY Hepatic Enzyme Increased Vegetamin A Hypotension (Vegetamin A) SS ORAL TABLE, DAILY Intra-Abdominal Thioridazine Haemorrhage Hydrochloride Muscle Necrosis (Thioridazine Muscle Rigidity Hydrochloride) SS ORAL MG, DAILY Neuroleptic Malignant Sultopride Syndrome Hydrochloride Oliguria (Sultopride Pyrexia Hydrochloride) C Renal Failure Lithium Carbonate Renal Failure Acute (Lithium Carbonate) C Rhabdomyolysis Flunitrazepam Shock (Flunitrazepam) C Swelling Distigmine Bromide Tachycardia (Distigmine Bromide) C Tremor Tamsulosin Hydrochloride (Tamsulosin Hydrochloride) C Pantethine (Pantethine) C Magnesium Oxide (Magnesium Oxide) C 22-Feb-2006 08:20 AM Page: 636 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sennosides (Sennosides) C Date:09/09/99ISR Number: 3343750-0Report Type:Expedited (15-DaCompany Report #JAUSA25101 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Study Risperdal (Tablet) Initial or Prolonged Congestive (Risperidone) PS ORAL Condition Aggravated Risperidone (Tablet) (Risperidone) SS ORAL Placebo (Placebo) SS ORAL 2 IN 1 DAY (S) Granulex (Spray) (G- Ranulex (R)) C Albuterol (Salbutamol) C Glyburide (Tablet) (Glibenclamide) C Ketoprofen (Tablet) (Ketoprofen) C Senokot (Tablet) (Sennosides) C Enalapril (Enalapril) C Guanfacine (Tablet) (Guanfacine) C Promethazine (Promethazine) C Acetaminophen (Paracetamol) C Phenergan (Promethazine) C Furosemide Tablet) (Furosemide) C Date:09/10/99ISR Number: 3345220-2Report Type:Direct Company Report # Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Risperidone PS Date:09/10/99ISR Number: 3345573-5Report Type:Expedited (15-DaCompany Report #JACGBR1999000323 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Risperdal Surgery Health (Unspecified) Professional (Risperidone) PS ORAL 4 MG DAILY ORAL Atenolol C Pain Killers C 22-Feb-2006 08:20 AM Page: 637 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/10/99ISR Number: 3345577-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999000800 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Angina Pectoris Foreign Risperidone Chest Pain Health (Unspecified) Condition Aggravated Professional (Risperidone) PS ORAL MG DAILY ORAL Fall Chlorpromazine And Mental Disorder Preparations Myocardial Infarction (Chlorpromazine) SS ORAL MG DAILY ORAL Oedema Peripheral Bromperidol Sudden Death (Unspecified) (Bromperidol) SS ORAL MG DAILY ORAL Timiperone (Timiperone) SS ORAL MG DAILY ORAL Biperiden And Preparations C Zopiclone C Brotizolam C Date:09/13/99ISR Number: 3344746-5Report Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Haloperidol Initial or Prolonged Heart Rate Increased Decanoate 100 Mg Required Hyperhidrosis American Intervention to Muscle Rigidity Pharmaceutical Inc. PS American Pharmacists Prevent Permanent Neuroleptic Malignant Inc INTRAVENOUS 0.8MG IM Impairment/Damage Syndrome 0.4MG/M Schizophrenia Thioridazine? Tremor Risperdal? SS Date:09/13/99ISR Number: 3345659-5Report Type:Expedited (15-DaCompany Report #99USA11023 Age:7 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Health Tofranil Tablet 25 Face Oedema Professional Mg (Imipramine Rash Erythematous Other Hydrochloride) PS ORAL 25 MG DAILY ORAL Risperdal Tablet (Risperidone) SS ORAL .5 MG DAILY ORAL Date:09/13/99ISR Number: 3346669-4Report Type:Expedited (15-DaCompany Report #JAUK43858 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchospasm Foreign Risperdal Hospitalization - Cardiac Arrest Health (Unspecified) Initial or Prolonged Cardiac Failure Professional (Risperidone) PS ORAL ORAL Cardiomegaly Cardiomyopathy Drug Interaction Pulmonary Oedema Supraventricular Tachycardia Tachycardia 22-Feb-2006 08:20 AM Page: 638 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/13/99ISR Number: 3346674-8Report Type:Expedited (15-DaCompany Report #JRFBEL1999000898 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Risperidone (Tablet) Hospitalization - Blood Creatine Increased Health (Risperidone) PS ORAL MG, DAILY, Initial or Prolonged Blood Creatine Professional ORAL Disability Phosphokinase Increased Haloperidol Required Blood Urea Increased (Unspecified) Intervention to C-Reactive Protein (Haloperidol) SS ORAL MG, DAILY, Prevent Permanent Increased ORAL Impairment/Damage Clonic Convulsion Levodopa Condition Aggravated (Benserazide Convulsion Hhydrochloride) SS ORAL ORAL Dialysis Trihexyphenidyl Difficulty In Walking Hydrochloride Dyskinesia (Trihexyphenidyl Eye Movement Disorder Hydrochloride) SS ORAL MG, DAILY, Fall ORAL Muscle Rigidity Amantadine Nasopharyngitis Hydrochloride Psychotic Disorder (Amantadine Pyrexia Hydrochloride) SS ORAL MG, DAILY, Renal Failure ORAL Respiratory Rate Bromocryptine Increased Mesylate Serotonin Syndrome (Bromocriptine Upper Respiratory Tract Mesilate) SS ORAL MG, DAILY, Infection ORAL Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) SS ORAL MG, DAILY, ORAL Biperiden And Preparations C Sennosides C Date:09/13/99ISR Number: 3346682-7Report Type:Expedited (15-DaCompany Report #JACGBR1999000330 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Serum Ferritin Decreased Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Depixol (Flupentixol Decanoate) SS Date:09/13/99ISR Number: 3346707-9Report Type:Expedited (15-DaCompany Report #JAUSA35799 Age:1 DY Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Distension Initial or Prolonged Blood Ph Decreased Bowel Sounds Abnormal Caesarean Section Cardiac Murmur Complications Of Maternal Exposure To Therapeutic Drugs 22-Feb-2006 08:20 AM Page: 639 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Convulsion Neonatal Cyanosis Neonatal Drug Withdrawal Syndrome Report Source Product Role Manufacturer Route Dose Duration Neonatal Health Risperdal(Tablet) Foetal Distress Syndrome Professional (Risperidone) PS ORAL ORAL Haematocrit Decreased Cocaine(Cocaine) SS ORAL ORAL Hyperreflexia Marijuana(Opiat) SS NASAL INHALA Intestinal Functional Unspecified Disorder (Benzodiazepine Maternal Use Of Illicit Derivatives) SS ORAL ORAL Drugs Depakote C Pallor Zoloft C Pco2 Decreased Ventolin C Petechiae Ventricular Septal Defect Date:09/17/99ISR Number: 3350095-1Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Clozapine PS 650 MG /DAY Neutrophil Count Risperidone SS 5MG/ DAY Decreased Lithium C White Blood Cell Count Benztropine C Decreased Date:09/17/99ISR Number: 3350194-4Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Joint Stiffness Risperdal PS CHRONIC Hospitalization - Mental Impairment THERAPY Initial or Prolonged Pyrexia Date:09/20/99ISR Number: 3351777-8Report Type:Expedited (15-DaCompany Report #JRFUSA1999002409 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Consumer Risperdal (Tablet) (Risperidone) PS ORAL ORAL Date:09/20/99ISR Number: 3351782-1Report Type:Expedited (15-DaCompany Report #JRFUSA1999002430 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Maculopathy Health Risperdal (Tablet) Vision Blurred Professional (Risperidone) PS ORAL 2 MG, 1 IN 1 DAY(S), ORAL Mellaril (Thioridazine Hydrochloride) SS ORAL 50 MG, 1 IN 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 640 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/99ISR Number: 3354890-4Report Type:Expedited (15-DaCompany Report #USA/99/02253/MEL Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Mellaril Initial or Prolonged Agitation (Thioridazine Required Drug Interaction Hydrochloride) PS ORAL 100 MG - 500 Intervention to Drug Level Above MG,ORAL Prevent Permanent Therapeutic Risperdal SS ORAL 10 MG, ONCE A Impairment/Damage Drug Level Below DAY, ORAL Therapeutic Tegretol SS 1000 MG, Psychotic Disorder Luvox SS ORAL ORAL Depakote C Cogentin C Mysoline C Date:09/22/99ISR Number: 3355083-7Report Type:Expedited (15-DaCompany Report #JRFUSA1999002392 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ear Infection Consumer Risperdal (Tablet) Initial or Prolonged (Risperidone) PS ORAL 3 MG, DAILY, Required ORAL Intervention to Doxepin C Prevent Permanent Cogentin C Impairment/Damage Hydroxyzine C ... C ... C Date:09/22/99ISR Number: 3355084-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999001192 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Risperidone Hospitalization - Neuroleptic Malignant (Unspecified) Initial or Prolonged Syndrome (Risperidone) PS MG, DAILY, ORAL ... C Date:09/22/99ISR Number: 3355085-0Report Type:Expedited (15-DaCompany Report #JACGER1999000529 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Foreign Risperdal Hospitalization - Fall Health (Unspecified Tablet) Initial or Prolonged Lethargy Professional (Risperidone) PS ORAL SEE IMAGE Required Mental Retardation Leponex (Clozapine) SS SEE IMAGE Intervention to Severity Unspecified Aponal (Doxepin Prevent Permanent Radius Fracture Hydrochloride) SS SEE IMAGE Impairment/Damage Sedation Fevarin (Fluvoxamine Maleate) SS ORAL DAILY, ORAL Ass C Xanef C 22-Feb-2006 08:20 AM Page: 641 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/99ISR Number: 3355086-2Report Type:Expedited (15-DaCompany Report #JRFUSA1999001379 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoventilation Health Risperdal ( 1 Mg Initial or Prolonged Muscular Weakness Professional Tablet) Required Pco2 Increased (Risperidone) PS ORAL 0.5 MG, 2 IN Intervention to Pneumonia 1 DAY(S), Prevent Permanent Respiratory Failure ORAL Impairment/Damage Urinary Retention Remeron (Mirtazapine) SS Celexa C Date:09/24/99ISR Number: 3356866-XReport Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Risperidone Initial or Prolonged Dystonia (Risperdal) PS Other Speech Disorder Date:09/24/99ISR Number: 3357554-6Report Type:Expedited (15-DaCompany Report #JAGER43823 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Foreign Risperdal (Tablet) Hospitalization - Fall Health (Risperidone) PS ORAL MG, DAILY, Initial or Prolonged Lethargy Professional ORAL Required Memory Impairment Leponex (Clozapine) SS MG, DAILY Intervention to Radius Fracture Aponal (Doxepin Prevent Permanent Sedation Hydrochloride) SS MG, DAILY Impairment/Damage Fevarin (Fluvoxamine Maleate) SS Ass C Xanef C Date:09/24/99ISR Number: 3357555-8Report Type:Expedited (15-DaCompany Report #JACGBR1999000034 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperdal (3 Mg Initial or Prolonged Dizziness Health Tablet) Loss Of Consciousness Professional (Risperidone) PS ORAL 3 MG, 2 IN 1 Meniere'S Disease DAY(S), ORAL Imdur C Nifedipine C Date:09/27/99ISR Number: 3357336-5Report Type:Direct Company Report # Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicidal Ideation Health Risperdal PS TABLETS 3 Hospitalization - Professional WEEKS 3 WK Initial or Prolonged 22-Feb-2006 08:20 AM Page: 642 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/99ISR Number: 3357383-3Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Erectile Dysfunction Risperidone PS Intervention to Prevent Permanent Impairment/Damage Date:09/27/99ISR Number: 3366244-5Report Type:Periodic Company Report #A001-002-003445 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Aricept (Donepezil) PS ORAL SEE IMAGE Hypotension Risperdal (Risperidone) SS ORAL NA, PER ORAL Zoloft (Sertraline Hydrochloride) C Date:09/28/99ISR Number: 3361695-7Report Type:Expedited (15-DaCompany Report #A044-002-001790 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Aricept (Donepezil) PS ORAL 10 MG (1 IN 1 Blood Creatine Health D), PER ORAL Phosphokinase Increased Professional Risperidone Drug Interaction (Risperidone) SS 0.5 MG Hyperhidrosis Pallor Date:09/29/99ISR Number: 3360672-XReport Type:Expedited (15-DaCompany Report #8-99264-156A Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blindness Health Ativan Tablet PS ORAL 1 DOSE , ORAL Initial or Prolonged Condition Aggravated Professional Depakote SS ORAL 250 MG, 3 IN Mental Disorder Other ONE DAY, ORAL Myopia Prozac SS ORAL 20 MG, 2 IN 1 Vision Blurred DAY, ORAL Visual Acuity Reduced Risperdal SS ORAL 2 MG, 2 IN ONE DAY, ORAL Date:10/01/99ISR Number: 3362845-9Report Type:Expedited (15-DaCompany Report #99USA10177 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Tegretol Tablet Initial or Prolonged Agitation Professional (Carbamazepine) PS ORAL 1000 MG DAILY Agranulocytosis Other ORAL Condition Aggravated Mellaril Unknown Drug Interaction (Thioridazine Drug Level Below Hydrochloride) SS ORAL ORAL Therapeutic Luvox Tablet Psychotic Disorder (Fluvoxamine Maleate) SS ORAL 200 MG DAILY ORAL Risperdal Tablet 10 Mg (Risperidone) SS ORAL 10 MG DAILY 22-Feb-2006 08:20 AM Page: 643 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Depakote C Cogentin C Mysoline C Date:10/01/99ISR Number: 3362975-1Report Type:Expedited (15-DaCompany Report #7398564 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Upper Health Abbott-Depakote PS Abbott ORAL 500.000 MG PO Hospitalization - Abscess Professional BID Initial or Prolonged Ascites Risperdal SS Inflammation Risperdal C Leukocytosis Klonopin C Liver Function Test Cipro C Abnormal Dilantin C Pancreatic Disorder Synthroid C Pancreatitis Ddavp C Pleural Effusion Peri-Colace C Sepsis Ativan C Staphylococcal Infection Vomiting Date:10/01/99ISR Number: 3373393-4Report Type:Periodic Company Report #001-0970-990014 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Consumer Cognex Capsules 30 Condition Aggravated Mg (Tacrine Postnasal Drip Hydrochloride) PS ORAL 120 MG (30 Salivary Hypersecretion MG, QID), PER Tardive Dyskinesia ORAL Vitamin B12 Decreased Risperdal (Risperidone) SS (Hydrochlorothiazide ) C Claritin (Loratadine) C Baby Asa (Acetylsalicylic Acid) C Vitamin B12 (Cyanocobalamin) C Vitamin E (Tocopherol) C Multivitamin (Vitamins Nos) C Date:10/04/99ISR Number: 3363292-6Report Type:Expedited (15-DaCompany Report #JRFBEL1999001314 Age:68 YR Gender:Female I/FU:I Outcome PT Hospitalization - Cerebral Infarction Initial or Prolonged Crying Required Delirium Intervention to Dialysis Prevent Permanent Drug Level Above Impairment/Damage Therapeutic Dysarthria 22-Feb-2006 08:20 AM Page: 644 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Faecal Incontinence Gait Disturbance Inadequate Diet Report Source Product Role Manufacturer Route Dose Duration Insomnia Foreign Risperidone (Tablet) Iron Deficiency Anaemia Health (Risperidone) PS ORAL MG, DAILY, Logorrhoea Professional ORAL Medication Error Lithium Carbonate Renal Impairment (Lithium Carbonate) SS ORAL MG, DAILY, Restlessness ORAL Therapeutic Agent Trihexyphenidyl Toxicity Hydrochloride C Thirst Brotizolam C Tremor Zopiclone C Aniracetam C Furosemide C Allopurinol C Probucol C Flunitrazepam C Temocapril Hydrochloride C Date:10/04/99ISR Number: 3363602-XReport Type:Expedited (15-DaCompany Report #JACGBR1999000323 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Risperdal (1 Mg/Ml Required Atrioventricular Block Health Liquid) Intervention to Cardiac Arrest Professional (Risperidone) PS ORAL 2 MG, 2 IN 1 Prevent Permanent Cardiovascular Disorder DAY(S), ORAL Impairment/Damage Circulatory Collapse Atenolol (Atenolol) C Deep Vein Thrombosis Co-Proxamol (Aporex) C Hypotension Diclofenac Pain (Diclofenac) C Pulmonary Embolism Cefadroxil (Cefadroxil) C Lactulose (Lactulose) C Senna (Senna) C Cefuroxime (Cefuroxime) C Flagyl (Metronidazole) C Gentamicin (Gentamicin) C Sucralfate (Sucralfate) C Date:10/04/99ISR Number: 3363612-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999001294 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Risperidone Initial or Prolonged Intestinal Obstruction Health (Unspecified) Professional (Risperidone) PS ORAL MG, DAILY, ORAL Paroxetine (Paroxetine) C 22-Feb-2006 08:20 AM Page: 645 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/99ISR Number: 3363904-7Report Type:Expedited (15-DaCompany Report #JRFUSA1999002524 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Health Risperdal (Tablet) Initial or Prolonged Breast Cancer Female Professional (Risperidone) PS ORAL 5 MG, DAILY, Required ORAL Intervention to Prevent Permanent Impairment/Damage Date:10/04/99ISR Number: 3363905-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999000380 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Foreign Risperidone Phosphokinase Increased Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Haloperidol (Unspecified) (Haloperidol) C Mosapramine Hydrochloride (Mosapramine Hydrochloride) C Levomepromazine Maleate (Levomepromazine Maleate) C Date:10/04/99ISR Number: 3363910-2Report Type:Expedited (15-DaCompany Report #JRFUSA1999002637 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Health Risperdal (1 Mg Initial or Prolonged Chest Pain Professional Tablet) Required Extrasystoles (Risperidone) PS ORAL 1 MG, DAILY , Intervention to Fall ORAL : 1.5 Prevent Permanent Gaze Palsy MG, DAILY, Impairment/Damage Mental Impairment ORAL Muscle Rigidity Ditropan Oxygen Saturation (Oxybutynin) C Decreased Amitriptyline Sedation (Amitriptyline) C Wrist Fracture Tylenol (Gel) (Acetic Acid) C Hydrocodone (Hydrocodone) C Date:10/04/99ISR Number: 3363912-6Report Type:Expedited (15-DaCompany Report #JRFUSA1999001909 Age:94 YR Gender:Male I/FU:F Outcome Life-Threatening Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:20 AM Page: 646 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Burns Second Degree Health Risperdal (Tablet) Hyperpyrexia Professional (Risperidone) PS ORAL 0.5 MG , 2 IN Neuroleptic Malignant 1 DAY(S), Syndrome ORAL Respiratory Distress Vasotec (Enalapril Maleate) C Lasix (Furosemide) C Potassium (Potassium) C Date:10/04/99ISR Number: 3363917-5Report Type:Expedited (15-DaCompany Report #JACGBR1999000355 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Foreign Risperdal Muscle Rigidity Health (Unspecified) Professional (Risperidone) PS ORAL 1 IN TIME(S), ORAL Date:10/06/99ISR Number: 3365890-2Report Type:Expedited (15-DaCompany Report #9940425 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zoloft Tablets PS ORAL 100.00 MG Drug Interaction Professional TOTAL:DAILY:O Drug Level Above RAL Therapeutic Cisapride SS ORAL ORAL Overdose Risperidone SS ORAL Sudden Death Bactrim Ds SS ORAL Norvasc C Prilosec C Hydrochlorothiazide C Cotrimoxazole C Date:10/07/99ISR Number: 3366977-0Report Type:Expedited (15-DaCompany Report #JAUSA25236 Age:42 YR Gender:Male I/FU:F Outcome PT Required Blood Cholesterol Intervention to Increased Prevent Permanent Blood Triglycerides Impairment/Damage Increased Chest Pain Dyskinesia Dyspnoea Electrocardiogram Qt Prolonged Erectile Dysfunction Gastrointestinal Disorder Haematuria Hypertension Jaundice Liver Function Test Abnormal Monoparesis 22-Feb-2006 08:20 AM Page: 647 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Rigidity Palpitations Pancreatic Disorder Report Source Product Role Manufacturer Route Dose Duration Psychomotor Retardation Consumer Risperdal (Tablet) Pyuria Health (Risperidone) PS ORAL 1 MG, 2 IN 1 Rectal Haemorrhage Professional DAY(S), ORAL Sperm Count Decreased Pravachol (Pravastatin) C Selenium Sulfate (Selenium Sulfide) C Lotrisone Cream (Lotrisone) C Niacin (Nicotinic-Acid) C Vitamin E (Tocopherol) C Tylenol (Paracetamol) C Ibruprofen (Ibuprofen) C Fish Oil Concentrate (Fish Oil) C Maalox (Maalox) C Date:10/07/99ISR Number: 3367642-6Report Type:Expedited (15-DaCompany Report #7399198 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Penile Pain Health Abbott - Depakote PS Abbott ORAL 500.000 MG PO Intervention to Priapism Professional TID Prevent Permanent Company Risperdal SS ORAL 3.000 MG PO Impairment/Damage Representative TID Other Risperdal C Zoloft C Date:10/07/99ISR Number: 3369286-9Report Type:Periodic Company Report #JRFUSA1999002320 Age:4 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pyrexia Consumer Risperdal (1mg/Ml Solution) (Risperidone) PS ORAL 0.25MG, I1 IN 1 DAY (S) ORAL Date:10/07/99ISR Number: 3369290-0Report Type:Periodic Company Report #JRFUSA1999002424 Age:4 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Headache Consumer Risperdal (1mg/Ml Initial or Prolonged Pneumonia Solution) (Risperidone) PS ORAL 0.5MG 1 IN 1 DAY (S) ORAL Nystatin (Nystatin) C 22-Feb-2006 08:20 AM Page: 648 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/99ISR Number: 3373371-5Report Type:Periodic Company Report #JRFUSA1999002037 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Risperdal (1 Mg/Ml Solution ) (Risperidone) PS ORAL 2 MG/ML, 2 IN 1 DAY(S) ORAL Haldol (Tablet) (Haloperidol) SS ORAL 5 MG, 2 IN 1 DAY(S) ORAL Cogentin (Benzatro-Pine Mesilate) C Date:10/07/99ISR Number: 3373372-7Report Type:Periodic Company Report #JRFUSA1999001067 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspepsia Consumer Risperdal (1 Mg/Ml Solution ) (Risperidone) PS ORAL 0.5 MG 2 IN 1 DAY(S) ORAL Depakote (Valproate Semisodium) C Clonidine (Clonidine) C Date:10/07/99ISR Number: 3373374-0Report Type:Periodic Company Report #JRFUSA1999002054 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nausea Consumer Risperdal (1 Mg/Ml Solution ) (Risperidone) PS ORAL 1 MG 1 IN 1 DAY(S) ORAL Date:10/07/99ISR Number: 3373376-4Report Type:Periodic Company Report #JRFUSA1999001008 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Risperdal (1 Mg/Ml Sedation Solution) (Risperidone) PS ORAL ORAL Risperdal (Tablet) (Risperidone) SS ORAL ORAL Date:10/08/99ISR Number: 3368940-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999001379 Age:26 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Risperidone Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Fluoxetine (Fluoxetine) SS ORAL ORAL Diphenhydramine (Diphenhydramine) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 649 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/99ISR Number: 3370171-7Report Type:Expedited (15-DaCompany Report #JACGER1999000624 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Risperdal (Tablet) Hospitalization - Phosphokinase Increased Health (Risperidone) PS ORAL 2 MG, DAILY, Initial or Prolonged Ecchymosis Professional ORAL Fall Haemorrhagic Stroke Hyponatraemia Inappropriate Antidiuretic Hormone Secretion Pyrexia Sedation Date:10/12/99ISR Number: 3370668-XReport Type:Expedited (15-DaCompany Report #9934510 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Apallic Syndrome Health Zoloft Tablets PS Intervention to Drug Interaction Professional Donepezil SS Prevent Permanent Insomnia Risperdal SS Impairment/Damage Syncope Date:10/12/99ISR Number: 3370787-8Report Type:Expedited (15-DaCompany Report #10130557 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Questran Drug Interaction Health (Cholestyramine) PS ORAL ORAL 2 MON Psychotic Disorder Professional Sulpiride SS 400 MILLIGRAM 2/1 DAY Risperidone SS Date:10/12/99ISR Number: 3370793-3Report Type:Expedited (15-DaCompany Report #9942186 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Pain Foreign Zoloft Tablets PS ORAL 50.00 MG Intervention to Asthenia Health TOTAL:DAILY:O Prevent Permanent Chest Pain Professional RAL Impairment/Damage Feeling Cold Risperidone SS ORAL 3.00 MG Fluid Overload TOTAL:BID:ORA Hyponatraemia L Malaise Levothyroxine C Muscle Spasms Date:10/12/99ISR Number: 3370823-9Report Type:Expedited (15-DaCompany Report #JRFUSA1999002694 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Meningitis Health Risperdal Initial or Prolonged Pyrexia Professional (Unspecified) Required (Risperidone) PS ORAL 6 MG, DAILY, Intervention to ORAL Prevent Permanent Impairment/Damage 22-Feb-2006 08:20 AM Page: 650 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/99ISR Number: 3370826-4Report Type:Expedited (15-DaCompany Report #JRFBEL1999001438 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Foreign Risperidone Phosphokinase Increased Health (Unspecified) Rhabdomyolysis Professional (Risperidone) PS ORAL ORAL Haldol (Unspecified) (Haloperidol) SS Date:10/12/99ISR Number: 3370828-8Report Type:Expedited (15-DaCompany Report #JRFBEL1999001434 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Risperidone (Tablet) Initial or Prolonged Appendicitis Health (Risperidone) PS ORAL MG, DAILY, Decreased Appetite Professional ORAL Headache Profenamine Malaise Hydrochloride Oral Intake Reduced (Profenamine) C Pallor Biperiden Hydrochloride (Biperiden Hydrochloride) C Clonazepam (Clonazepam) C Levomepromazine Maleate (Levomepromazine Maleate) C Rilmazafone Hydrochloride (Rilmazafone) C Date:10/12/99ISR Number: 3372919-4Report Type:Expedited (15-DaCompany Report #PRIUSA1999006850 Age:39 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Ultram (50 Mg Hospitalization - Completed Suicide Health Tablet) (Tramadol Initial or Prolonged Intentional Overdose Professional Hydrochloride) PS ORAL ORAL Risperdal (Unspecified) (Risperidone) SS ORAL ORAL Amitriptyline (Amitriptyline) SS ORAL ORAL Risperdal (Unspecified) (Risperidone) SS Date:10/13/99ISR Number: 3371580-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999001438 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Foreign Haldol (Unspecified) Phosphokinase Increased Health (Haloperidol) PS Rhabdomyolysis Professional Risperidone (Unspecified) (Risperidone) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 651 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/14/99ISR Number: 3373242-4Report Type:Expedited (15-DaCompany Report #JACFRA1999000364 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Foreign Risperdal (1 Mg Initial or Prolonged Convulsion Health Tablet) Electroencephalogram Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 Abnormal DAY (S), ORAL Pyrexia Xanax (Alprazolam) SS ORAL 1 MG, 1 IN 1 DAY (S), ORAL;0.5 MG, 1 IN 1 DAY(S), ORAL Date:10/14/99ISR Number: 3373246-1Report Type:Expedited (15-DaCompany Report #JAKYO40181 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Akinesia Foreign Risperidone Bradykinesia Health (Unspecified) Condition Aggravated Professional (Risperidone) PS ORAL 2 MG, DAILY, Difficulty In Walking ORAL; 4 MG, Dysphonia DAILY, ORAL Eating Disorder Domperidone (Tablet) Hallucination (Domperidone) SS ORAL 20 MG, DAILY, Hyperhidrosis ORAL Muscle Rigidity Pentobarbital Paralysis Calcium (Tablet) Parkinson'S Disease (Pentobarbital) C Brotizolam (Tablet) (Brotizolam) C Rebamipide (Tablet) (Rebamipide) C Neodopaston (R) (Tablet) (Neodopaston (R)) C Bromocriptine (Tablet) (Bromocriptine) C Droxidopa (Droxidopa) C Sennosides (Tablet) (Sennosides) C Date:10/15/99ISR Number: 3373513-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999001602 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Risperidone Initial or Prolonged Health (Unspecified) Professional (Risperidone) PS ORAL MG, DAILY, ORAL Haldol Deconate (Unspecified) (Haloperidoldeconate ) C 22-Feb-2006 08:20 AM Page: 652 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/99ISR Number: 3373536-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999001438 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Foreign Risperidone Initial or Prolonged Anuria Health (Unspecified) Other Blood Creatine Professional (Risperidone) PS ORAL MG, DAILY, Required Phosphokinase Increased ORAL Intervention to Blood Creatinine Haldol (Unspecified) Prevent Permanent Increased (Haloperidol) SS ORAL DAILY, ORAL Impairment/Damage Blood Urea Increased Pravastatin Chromaturia (Pravastatin Sodium) SS ORAL MG, DAILY, Pyelonephritis ORAL Renal Failure Fluphenazine Maleate SS ORAL DAILY, ORAL Rhabdomyolysis Carbamazepine Urinary Retention (Carbamazepine) C Promazine Hydrochloride (Promazine Hydrochloride) C Levopromazine Maleate (Levopromazine Maleate) C Date:10/15/99ISR Number: 3373538-6Report Type:Expedited (15-DaCompany Report #JRFBEL1999001314 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperidone (Tablet) Initial or Prolonged Phosphokinase Increased Health (Risperidone) PS PT TOOK 5 MG Required Blood Prolactin Increased Professional INSTEAD OF 2 Intervention to C-Reactive Protein MG Prevent Permanent Increased (MISUNDERSTOO Impairment/Damage Crying D) Delirium Lithium Carbonate Difficulty In Walking (Lithium Carbonate) C Dry Mouth Trihexyphenidyl Dysarthria Hydrochloride Faecal Incontinence (Trihexyphenidyl Gait Disturbance Hydrochloride) C Iron Deficiency Anaemia Brotizolam Logorrhoea (Brotizolam) C Mania Zopiclone Medication Error (Zopiclone) C Nervous System Disorder Aniracetam Renal Disorder (Aniracetam) C Restlessness Furosemide Sedation (Furosemide) C Therapeutic Agent Allopurinol Toxicity (Allopurinol) C Thirst Probucol (Probucol) C Tremor Flunitrazepam (Flunitrazepam) C Temocapril Hydrochloride (Temocapril Hydrochloride) C 22-Feb-2006 08:20 AM Page: 653 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/99ISR Number: 3373540-4Report Type:Expedited (15-DaCompany Report #JAKYO10473 Age:0 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Congenital Foreign Risperidone Initial or Prolonged Hypotonia Health (Risperidone) PS TAKEN BY Required Cardiac Disorder Professional MOTHER DURING Intervention to Complications Of Maternal PREGNANCY Prevent Permanent Exposure To Therapeutic Flunitrazepam Impairment/Damage Drugs (Flunitrazepam) SS TAKEN BY Congenital Nystagmus MOTHER DURING Convulsion Neonatal PREGNANCY Cyanosis Neonatal Clomipramine Drug Withdrawal Syndrome Hydroxide Neonatal (Clomipramine Foetal Distress Syndrome Hydrochloride) SS TAKEN BY Hyperreflexia MOTHER DURING Irritability PREGNANCY Liver Function Test Trimipramine Maleate Abnormal (Trimipramine Muscle Twitching Maleate) C Pco2 Increased Transient Tachypnoea Of The Newborn Tremor Neonatal Date:10/15/99ISR Number: 3374207-9Report Type:Expedited (15-DaCompany Report #9843322 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zoloft Tablets PS ORAL 25.00MG TOTAL Initial or Prolonged Agitation DAILY ORAL Required Anger Aricept SS Intervention to Cerebrovascular Accident Xanax SS Prevent Permanent Dementia Alzheimer'S Type Risperidol SS ORAL 1.50MG TOTAL Impairment/Damage Dermatitis BID ORAL Diarrhoea Ben Cay C Disturbance In Social Zyprexa C Behaviour Klonapin C Dizziness Serzone C Drug Effect Decreased Unspecified Drug Ineffective Antioxidants C Drug Interaction Tylendol C Feeling Jittery Hypersomnia Kyphosis Nervousness Restlessness Sedation Thinking Abnormal Vomiting Date:10/18/99ISR Number: 3374952-5Report Type:Expedited (15-DaCompany Report #A044-002-001790 Age:67 YR Gender:Male I/FU:F Outcome PT Other Blood Creatine Phosphokinase Increased Drug Interaction Dysgeusia 22-Feb-2006 08:20 AM Page: 654 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperhidrosis Pallor Report Source Product Role Manufacturer Route Dose Duration Foreign Aricept (Donepezil) PS ORAL 5 MG, 1 IN 1 Health D, PER ORAL Professional Risperidone (Risperidone) SS 0.05 MG Aricept SS ORAL 10 MG, 1 IN 1 D, PER ORAL Date:10/18/99ISR Number: 3375765-0Report Type:Expedited (15-DaCompany Report #JRFBEL1999000289 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Risperidone (Tablet) Myocardial Infarction Health (Risperidone) PS ORAL MG, DAILY, Thrombocytopenia Professional ORAL Bezafibrate (Bezafibrate) C Sulpiride (Sulpiride) C Date:10/18/99ISR Number: 3380979-XReport Type:Periodic Company Report #990705-SK783 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Celebrex PS ORAL 100.000 MG Extrapyramidal Disorder Professional BID PO Sedation Risperdal SS ORAL 3.000 MG QD PO Furosemide C Doxazosin C Date:10/19/99ISR Number: 3375144-6Report Type:Direct Company Report # Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal 2mg Tabs PS ORAL 2MG PO HS Phosphokinase Increased Confusional State Difficulty In Walking Hallucination Joint Stiffness Mental Impairment Neuroleptic Malignant Syndrome Paranoia Pyrexia Speech Disorder Date:10/21/99ISR Number: 3378155-XReport Type:Expedited (15-DaCompany Report #JRFBEL1999001438 Age:43 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged Other 22-Feb-2006 08:20 AM Page: 655 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Acidosis Foreign Haldol PS ORAL DAILY, ORAL Anuria Health (SEE IMAGE) Blood Creatine Professional Risperidone Phosphokinase Increased (Risperidone) SS ORAL MG, DAILY, Blood Creatinine ORAL Increased Pravastatin Blood Urea Increased (Pravastatin Chromaturia Sodium) SS ORAL MG, DAILY, Haemodialysis ORAL Pyelonephritis Fluphenazine Maleate SS ORAL MG, DAILY, Renal Failure ORAL Rhabdomyolysis Carbamazepine Urinary Retention (Carbamazepine) C Promazine Hydrochloride (Promazine Hydrochloride) C Levomepromazine Maleate (Levomepromazine Maleate) C . Date:10/21/99ISR Number: 3378233-5Report Type:Expedited (15-DaCompany Report #JRFBEL1999001659 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Health Risperdal Exposure To Therapeutic Professional (Unspecified) Drugs (Risperidone) PS SEE IMAGE Congenital Genitourinary Clopixol Abnormality (Zuclopenthixol Hydrocele Decanoate) C Pregnancy Carbamazepine (Carbamazepine) C Flupentixol (Flupentixol) C Clonazepam (Clonazepam) C Nitrous Oxide (Nitrous Oxide) C Haloperidol (Haloperidol) C Benztropine C Date:10/21/99ISR Number: 3378987-8Report Type:Periodic Company Report #JRFUSA1999002960 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Health Risperdal Initial or Prolonged Complete Professional (Unspecified) Bradycardia (Risperidone) PS ORAL ORAL Cardio-Respiratory Arrest Sedation 22-Feb-2006 08:20 AM Page: 656 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/99ISR Number: 3378989-1Report Type:Expedited (15-DaCompany Report #JACGBR1999000401 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Foreign Risperdal (3 Mg Consciousness Tablet)(Risperidone) PS ORAL 15 MG, 1 IN 1 Medication Error TIME(S), ORAL Mental Impairment Date:10/22/99ISR Number: 3379460-3Report Type:Expedited (15-DaCompany Report #7399261 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Depakote PS Abbott ORAL PO Initial or Prolonged Sedation Professional Risperdal SS ORAL 2.000 MG PO Other TID Synthroid C Nifedipine C Aspirin C Date:10/22/99ISR Number: 3379578-5Report Type:Expedited (15-DaCompany Report #JAUSA35881 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Health Risperdal (3 Mg Initial or Prolonged Binocular Eye Movement Professional Tablet) Required Disorder (Risperidone) PS ORAL 9 MG, DAILY, Intervention to Blood Creatine ORAL: 3 MG, 1 Prevent Permanent Phosphokinase Increased IN 1 DAY(S), Impairment/Damage Clonic Convulsion ORAL: 3MG, 2 Coma IN 1 DAY(S), Confusional State Seroquel Dementia (Quetiapine) SS ORAL 600 MG , Dysarthria DAILY, ORAL Encephalopathy Thorazine (Tablet) Extensor Plantar Response (Chlorpromazine) SS ORAL 200 MG, 1 IN Eye Rolling 1 DAY(S), Hypoxia ORAL Muscle Rigidity Phencyclidine Neuroleptic Malignant (Phencyclidine) SS Syndrome Klonopin (Tablet) Pyrexia (Clonazepam) C Respiratory Failure Prolixin Stupor (Fluphenazine Tachycardia Hydrochloride) C Tremor Olanzapine Vomiting (Olanzapine C Date:10/22/99ISR Number: 3379581-5Report Type:Expedited (15-DaCompany Report #JRFUSA1999002961 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Risperdal Initial or Prolonged Drug Level Above Professional (Unspecified) Therapeutic (Risperidone) PS ORAL ORAL Inderal (Propranolol Hydrochloride) SS 22-Feb-2006 08:20 AM Page: 657 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/99ISR Number: 3379662-6Report Type:Direct Company Report # Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Risperidone Musculoskeletal Stiffness (Risperdal) PS 0.25MG BID Speech Disorder Trazodone C Torticollis Ibuprofen C Date:10/25/99ISR Number: 3381372-6Report Type:Expedited (15-DaCompany Report #1999001588FR Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Health Xanax (Alprazolam) Initial or Prolonged Convulsion Professional Tablet, 0,5mg PS ORAL 2 MG, QD, Febrile Convulsion ORAL Infection Risperdal Muscle Rigidity (Risperidone) Pyrexia Tablet, 1 Mg SS ORAL 2 MG, QD, Sedation ORAL Date:10/25/99ISR Number: 3381833-XReport Type:Expedited (15-DaCompany Report #JRFBEL1999001679 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Literature Risperidone Cardiac Disorder Health (Unspecified) Coronary Artery Disease Professional (Risperidone) PS Ecchymosis Alprazolam Excoriation (Alprazolam) SS Fall Paroxetine Pulmonary Congestion (Paroxetine) SS Pulmonary Oedema Remeron Toxicologic Test Abnormal (Mirtazapine) SS ORAL ORAL Date:10/25/99ISR Number: 3381834-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999001677 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Literature Risperidone Cardio-Respiratory Arrest Health (Unspecified) Coma Professional (Risperidone) PS ORAL 1 MG 2 Coronary Artery Disease IN 1 DAY(S) Toxicologic Test Abnormal ORAL Gabapentin (Gabapentin) SS 300 MG 2 IN 1 DAY(S) Clonazepam (Clonazepam) SS 10 MG 1 IN 1 DAY(S) Paroxetine (Paroxetine) SS 10 MG 1 IN 1 DAY(S) Remeron (Mirtazapine) SS ORAL 15 MG 3 IN 1 DAY(S) ORAL 22-Feb-2006 08:20 AM Page: 658 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/99ISR Number: 3384065-4Report Type:Expedited (15-DaCompany Report #JRFUSA1999002984 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Health Risperdal (Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL 4 MG, DAILY, Required ORAL Intervention to Prevent Permanent Impairment/Damage Date:10/29/99ISR Number: 3392347-5Report Type:Periodic Company Report #8-99113-032A Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Ativan Tablets PS ORAL DOSE UNKNOWN Drug Withdrawal Syndrome ORAL Gait Disturbance Risperdal Visual Disturbance (Risperidone) Tablets SS ORAL 5 MG, ONCE DAILY, 4 MG ON 30-MAR-99 ORAL Paxil (Paroxetine) C Atenolol C Date:10/29/99ISR Number: 3392856-9Report Type:Periodic Company Report #8-98313-022A Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Consumer Ativan Tablets PS ORAL DOSE UNKNOWN ORAL Depakote (Valproic Acid) SS ORAL DOSE UNKNOWN ORAL Risperdal (Risperidal) SS ORAL DOSE UNKNOWN ORAL Date:10/29/99ISR Number: 3393338-0Report Type:Periodic Company Report #8-98345-066A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Health Ativan Tablets PS ORAL DOSE UNKNOWN Sedation Professional ORAL Duragesic (Fentanyl) Patch SS TRANSDERMAL DOSE UNKNOWN TRANSDERMAL Risperdal (Risperidone) Tablets SS ORAL 0.5 MG (2 TABLETS) DAILY (IN MORNING AND AT BEDTIME) 22-Feb-2006 08:20 AM Page: 659 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/99ISR Number: 3393359-8Report Type:Periodic Company Report #8-98281-023A Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Ativan Tablets PS ORAL DOSE UNKNOWN Speech Disorder ORAL Thinking Abnormal Risperdal (Risperidone) Tablets SS ORAL 0.5 MG TWICE DAILY ORAL Ambien (Zolpidem) C Risperdal (Ripseridone) C Date:11/01/99ISR Number: 3385425-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Risperidol PS Phosphokinase Increased Muscle Spasms Date:11/01/99ISR Number: 3385574-4Report Type:Direct Company Report # Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Risperidone 0.5ng Initial or Prolonged Depressed Level Of 1/2 Am 1/2 Pm PS Consciousness Amitriptyline 10mg SS Extrapyramidal Disorder Darvocet N-100 SS Joint Stiffness Ditropan 1qd SS Lethargy Muscle Rigidity Date:11/01/99ISR Number: 3386313-3Report Type:Direct Company Report # Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Risperidone 1 Mg Tab PS ORAL 0.5MG (1/2 OF Drooling Professional A 1 MG TAB) QHS PO Acetaminophen C Aloh/Mgoh/Simth C Alprazolam C Artificial Tears Poly Vinyl Alcohol C Cyanocobalamin C Docusate C Donepezil Hcl C Imipramine Hcl C Lorazepam C Propoxyphene-N-100 & Apap C Psyllium C Trazodone C Multivitamin/Mineral C 22-Feb-2006 08:20 AM Page: 660 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/99ISR Number: 3387512-7Report Type:Expedited (15-DaCompany Report #JRFBEL1999001735 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Literature Risperidone Hospitalization - Blood Ph Increased Health (Unspecified) Initial or Prolonged Cardiac Arrest Professional (Risperidone) PS ORAL 28, 1 IN 1 Required Completed Suicide TIME (S), Intervention to Confusional State ORAL Prevent Permanent Disorientation Aspirin SS ORAL ORAL Impairment/Damage Drug Level Above Lithium (Lithium) SS ORAL ORAL Therapeutic Dyspnoea Hyperhidrosis Intentional Overdose Nausea Pco2 Decreased Respiratory Rate Increased Vomiting Date:11/02/99ISR Number: 3387313-XReport Type:Direct Company Report # Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dyskinesia Health Risperdal 2mg Muscle Twitching Professional Tablets PS ORAL 2MG ORALLY BID Ranitidine C Tranzodone C Clonazepam C Pentoxyfilline C Date:11/02/99ISR Number: 3387850-8Report Type:Expedited (15-DaCompany Report #US_991030118 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Sleep-Related Study Risperidone PS Initial or Prolonged Event Health Delusional Disorder, Professional Persecutory Type Date:11/03/99ISR Number: 3389113-3Report Type:Expedited (15-DaCompany Report #JACGER1999000699 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Risperdal Hospitalization - Health (Unspecified) Initial or Prolonged Professional (Risperidone) PS ORAL ORAL Company Representative Date:11/03/99ISR Number: 3389115-7Report Type:Expedited (15-DaCompany Report #JRFBEL1999001602 Age:52 YR Gender:Male I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:20 AM Page: 661 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Blood Creatine Foreign Risperidone Phosphokinase Increased Health (Unspecified) Blood Creatinine Professional (Risperidone) PS ORAL MG, DAILY, Increased ORAL Blood Urea Increased Haldol Decanoate Myoglobinuria (Unspecified) Oral Intake Reduced (Haloperidol Paralysis Decanoate) SS INTRAMUSCULAR 50 MG, 1 IN 1 Pyrexia MONTH(S), IM Rhabdomyolysis Date:11/03/99ISR Number: 3389116-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999001438 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Foreign Risperidone Initial or Prolonged Anuria Health (Unspecified) Other Blood Creatine Increased Professional (Risperidone) PS ORAL MG, DAILY, Required Blood Creatine ORAL Intervention to Phosphokinase Increased Haloperidol Prevent Permanent Blood Urea Increased (Unspecified) Impairment/Damage Chromaturia (Haloperidol) SS ORAL G, DAILY, Haemodialysis ORAL (SEE Myocardial Infarction IMAGE) Pyelonephritis Pravastatin Sodium Renal Failure (Pravastatin Sodium) SS ORAL MG, DAILY, Rhabdomyolysis ORAL Urinary Retention Fluphenazine Maleate SS ORAL MG, DAILY, ORAL Carbamazepine (Carbamazepine) C Promazine Hydrochloride (Promazine Hydrochloride) C Levomepromazine Maleate (Levomepromazine Maleate) C Date:11/03/99ISR Number: 3389117-0Report Type:Expedited (15-DaCompany Report #JRFUSA1999003142 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Health Risperdal (1 Mg/Ml Initial or Prolonged Professional Solution) (Risperidone) PS ORAL 2.5 MG, 1 IN 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 662 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/04/99ISR Number: 3388811-5Report Type:Expedited (15-DaCompany Report #JRFBEL1999001775 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Risperidone (Tablet) Initial or Prolonged Consciousness Health (Risperidone) PS ORAL MG DAILY ORAL Gastrointestinal Professional Amezinium Haemorrhage Metilsulfate Haematemesis (Amezinium Hepatic Encephalopathy Metilsulfate) C Tremor Sennoside (Sennosides) C Magnesium Oxide (Magnesium Oxide) C Ursodesoxycholic Acid (Tauroursodesoxychol ic Acid) C Diazepam (Diazepam) C Sodium Valproate (Valproate Sodium) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Cisapride (Unspecified) (Cisapride) C Brotizolam (Brotizolam) C Amantadine Hydrochloride (Amantadine Hydrochloride) C Lactulose (Lactulose) C Kanamycin Monosulfate (Kanamycin) C Furosemide (Furosemide) C Spironolactone (Spironolactone) C Human Serum Albumin (Human Albumin) C Date:11/04/99ISR Number: 3388883-8Report Type:Expedited (15-DaCompany Report #A044-002-001834 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Foreign Aricept (Donepezil) PS ORAL 10 MG, 1 IN 1 Discomfort Health D, PER ORAL Drug Interaction Professional Zuclopenthixol Extrapyramidal Disorder (Zuclopenthixol) SS Oral Intake Reduced Fluvoxamine Parkinson'S Disease (Fluvoxamine) SS ORAL PER ORAL Salivary Hypersecretion Risperdal Sedation (Risperidone) SS ORAL PER ORAL Oxprenolol (Oxprenolol) C Bisoprolol 22-Feb-2006 08:20 AM Page: 663 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Bisoprolol) C Omeprazole (Omeprazole) C Prazepam (Prazepam) C Date:11/05/99ISR Number: 3389424-1Report Type:Direct Company Report # Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperthermia Malignant Haldol PS Muscle Rigidity Risperidal SS Neuroleptic Malignant Syndrome Date:11/05/99ISR Number: 3390213-2Report Type:Expedited (15-DaCompany Report #1999001588FR Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Foreign Xanax (Alprazolam) Initial or Prolonged Convulsion Health Tablet, 0.5mg PS ORAL 2 MG, QD, Febrile Convulsion Professional ORAL Infection Other Risperdal Movement Disorder (Risperidone) Muscle Rigidity Tablet, 1 Mg SS ORAL 2 MG, QD, Nervous System Disorder ORAL Poverty Of Speech Pyrexia Sedation Date:11/08/99ISR Number: 3390658-0Report Type:Expedited (15-DaCompany Report #JRFBEL1999000914 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Candidiasis Foreign Risperdal (Tablet) Hospitalization - Dysphagia Health (Risperidone) PS ORAL MG, DAILY, Initial or Prolonged Laryngeal Oedema Professional ORAL Required Leukopenia Neozine Intervention to Neutropenia (Levomepromazine Prevent Permanent Pyrexia Hydrochloride) C Impairment/Damage Respiratory Failure Artane Tonsillitis (Trihexyphenidyl Hydrochloride) C Fenergan (Promethazine) C Date:11/08/99ISR Number: 3390661-0Report Type:Expedited (15-DaCompany Report #JRFBEL1999001747 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperidone Choking Health (Unspecified) Depressed Level Of Professional (Risperidone) PS ORAL MG, DAILY, Consciousness ORAL Epilepsy Sodium Valproate Injury Asphyxiation (Valproic Acid) SS ORAL MG, DAILY, Vomiting ORAL Polaramine (Dexchlorpheniramine 22-Feb-2006 08:20 AM Page: 664 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maleate) SS ORAL MG, DAILY, ORAL Carbocisteine (Carbocisteine) SS ORAL MG, DAILY, ORAL Date:11/08/99ISR Number: 3390760-3Report Type:Expedited (15-DaCompany Report #9946209 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Health Zoloft Tablets PS Drug Level Above Professional Risperdal SS Therapeutic Company Norvasc C Drug Toxicity Representative Prilosec C Propulsid C Hydrochlorothiazide C Date:11/08/99ISR Number: 3390791-3Report Type:Expedited (15-DaCompany Report #JRFBEL1999001438 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Foreign Haloperidol(Unspecif Initial or Prolonged Anuria Health ied)(Haloperidol) PS ORAL MG, DAILY, Other Blood Creatine Professional ORAL Required Phosphokinase Increased Risperidone Intervention to Blood Creatinine (Unspecified) Prevent Permanent Increased (Risperidone) SS ORAL MG, DAILY, Impairment/Damage Blood Urea Increased ORAL Chromaturia Pravastatin Sodium Haemodialysis (Pravastatin Sodium) SS ORAL MG, DAILY, Pyelonephritis ORAL Renal Failure Fluphenazine Maleate Rhabdomyolysis (Fluphenazine Urinary Retention Maleate) SS ORAL MG, DAILY, ORAL Carbamazepine (Carbamazepine) C Promazine Hydrochloride (Promazine Hydrochloride) C Levomepromazine Maleate (Levomepromazine Maleate) C Date:11/08/99ISR Number: 3391300-5Report Type:Expedited (15-DaCompany Report #US_991030118 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Study Risperidone PS Initial or Prolonged Insomnia Health Paranoia Professional Schizophrenia 22-Feb-2006 08:20 AM Page: 665 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/99ISR Number: 3391463-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999001602 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Haldol Decanoate Hospitalization - Phosphokinase Increased Health (Unspecified) Initial or Prolonged Blood Creatinine Professional (Haloperidol Required Increased Decanoate) PS INTRAMUSCULAR 50 MG, 1 IN 1 Intervention to Blood Urea Increased MONTH(S), IM Prevent Permanent Haemodialysis Risperidone Impairment/Damage Myoglobin Blood Increased (Unspecified) Myoglobinuria (Risperidone) SS ORAL MG, DAILY, Oral Intake Reduced ORAL Paralysis Pyrexia Rhabdomyolysis Date:11/09/99ISR Number: 3392865-XReport Type:Direct Company Report #USP 081224 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Synthroid (Levothyroxine) PS Qualitest Risperdal(Risperidon e) SS Janssen Date:11/12/99ISR Number: 3396428-1Report Type:Expedited (15-DaCompany Report #JACGBR1999000420 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:11/12/99ISR Number: 3397070-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999001477 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysuria Foreign Haloperidol Initial or Prolonged Health (Injection) Required Professional (Haloperidol) PS INTRAVENOUS MG, DAILY, IV Intervention to Haloperidol Prevent Permanent (Unspecified) Impairment/Damage (Haloperidol) SS ORAL MG, DAILY, ORAL Risperidone (Unspecified) (Risperidone) SS ORAL MG, DAILY, ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS ORAL MG, DAILY, ORAL Bromazepam (Bromazepam) SS ORAL MG, DAILY, ORAL Trihexyphenidyl Hydrochloride 22-Feb-2006 08:20 AM Page: 666 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Trihexyphenidyl Hydrochloride) SS ORAL MG, DAILY, ORAL Date:11/16/99ISR Number: 3397466-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Nifedipine 30mg Xr PS ORAL 30MG AM ORAL White Blood Cell Count Risperidone 4mg Decreased Tablets SS ORAL 4MG HS ORAL Fluphenazine C Decanoate C Gabapentin C Benztropine C Kytrin C Doxepin C Date:11/16/99ISR Number: 3398648-9Report Type:Direct Company Report # Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Risperidone PS Life-Threatening Professional Valproic Acid SS Hospitalization - Prednisone C Initial or Prolonged Disability Congenital Anomaly Other Date:11/17/99ISR Number: 3399561-3Report Type:Expedited (15-DaCompany Report #JRFUSA1999003523 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ammonia Increased Health Risperdal (Tablet) Initial or Prolonged Dehydration Professional (Risperidone) PS ORAL ORAL Required Dizziness Zoloft (Sertraline Intervention to Nausea Hydrochloride) C Prevent Permanent Trazodone Impairment/Damage (Trazodone) C Date:11/17/99ISR Number: 3399562-5Report Type:Expedited (15-DaCompany Report #JRFUSA1999003577 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Risperdal Therapeutic Agent Professional (Unspecified) Toxicity (Risperidone) PS ORAL ORAL Digoxin (Digoxin) SS Date:11/17/99ISR Number: 3399769-7Report Type:Expedited (15-DaCompany Report #JRFUSA1999001315 Age:69 YR Gender:Male I/FU:F Outcome Life-Threatening Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 667 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Aortic Aneurysm Consumer Risperdal (2 Mg Tablet) (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY(S), ORAL Zoloft (Sertraline Hydrochloride) C Lescol (Fluvastatin Sodium) C Prilosec (Omeprazole) C Date:11/17/99ISR Number: 3400289-1Report Type:Expedited (15-DaCompany Report #9940425 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Antidepressant Drug Level Health Zoloft Tablets PS ORAL 100.00 MG Above Therapeutic Professional TOTAL: DAILY: Arrhythmia ORAL Drug Interaction Cisapride SS ORAL 40.00 MG Myocardial Fibrosis TOTAL: QID: Overdose ORAL Urinary Incontinence Risperidone SS ORAL 6.00 MG TOTAL: BID: ORAL Bactrim Ds SS ORAL BID: ORAL Norvasc C Prilosec C Hydrochlorothiazide C Cotrimoxazole C Date:11/18/99ISR Number: 3401599-4Report Type:Expedited (15-DaCompany Report #JRFUSA1999003509 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Lymphocytic Health Risperdal (1 Mg Hospitalization - Leukaemia Professional Tablet) Initial or Prolonged (Risperidone) PS ORAL 1 MG, 1 IN 1 Required DAY(S), ORAL Intervention to Ritalin Prevent Permanent (Methylphenidate Impairment/Damage Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:11/18/99ISR Number: 3402525-4Report Type:Periodic Company Report #9839429 Age:85 YR Gender:Female I/FU:I Outcome PT Other Anorexia Asthenia Dizziness Dyspepsia Epistaxis Psychotic Disorder 22-Feb-2006 08:20 AM Page: 668 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Vasodilatation Report Source Product Role Manufacturer Route Dose Duration Health Sinequan Capsules PS Professional Risperdal SS ORAL 1.00 MG TOTAL;BID; ORAL Desyrel C Serzone C Ativan C Date:11/19/99ISR Number: 3402997-5Report Type:Expedited (15-DaCompany Report #JRFBEL1999001857 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Risperidone Initial or Prolonged Anxiety Literature (Unspecified) Blood Pressure Increased Health (Risperidone) PS ORAL 1 MG 2 Condition Aggravated Professional IN 1 DAY(S) Decreased Activity ORAL Decreased Appetite Haldol (Unspecified) Depressed Mood (Haloperidol) SS ORAL MG DAILY Dyspnoea ORAL 6 YR Dystonia Buspirone Hyperhidrosis (Buspirone) C Intraocular Pressure Timolol (Timolol) C Increased Lethargy Movement Disorder Panic Reaction Polydipsia Polyuria Posture Abnormal Respiratory Disorder Tachycardia Date:11/19/99ISR Number: 3403001-5Report Type:Expedited (15-DaCompany Report #JRFUSA1999003642 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Consumer Risperdal (Tablet) Initial or Prolonged Fracture (Risperidone) PS ORAL ORAL Date:11/19/99ISR Number: 3403004-0Report Type:Expedited (15-DaCompany Report #JACGBR1999000496 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal Glaucoma Health (Unspecified) Retinal Detachment Professional (Risperidone) PS ORAL ORAL Company Representative 22-Feb-2006 08:20 AM Page: 669 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/99ISR Number: 3403006-4Report Type:Expedited (15-DaCompany Report #JACGBR1999000498 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Disorder Foreign Risperdal Retinal Vascular Consumer (Unspecified) Occlusion (Risperidone) PS ORAL ORAL Visual Disturbance Date:11/22/99ISR Number: 3404162-4Report Type:Direct Company Report # Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Enzymes Increased Health Risperidone PS 1MG TID Hospitalization - Hypertension Professional 4/3-4/4 Initial or Prolonged Risperidone SS 1MG BID 4/5-4/12 Risperidone SS 0.5MG BID 4/13-4/18 Risperidone SS 0.5MG AM + 1 MG HS 4/19-4/26 Date:11/22/99ISR Number: 3415585-1Report Type:Periodic Company Report #S99-USA-01646-01 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Celexa PS ORAL 20 MG QD PO Attention Risperdal SS Deficit/Hyperactivity Glucophage C Disorder Chest Pain Hypertonia Insomnia Vomiting Date:11/23/99ISR Number: 3405871-3Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Penile Pain Risperidone PS ORAL 3MG HS OI Initial or Prolonged Priapism Multivitamins C Required Intervention to Prevent Permanent Impairment/Damage Date:11/23/99ISR Number: 3406618-7Report Type:Periodic Company Report #USA/99/01013/LEX Age:45 YR Gender:Female I/FU:I Outcome PT Hospitalization - Attention Initial or Prolonged Deficit/Hyperactivity Required Disorder Intervention to Confusional State Prevent Permanent Emotional Disorder Impairment/Damage Extrapyramidal Disorder Hallucination 22-Feb-2006 08:20 AM Page: 670 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paranoia Tachycardia Report Source Product Role Manufacturer Route Dose Duration Health Clozaril (Clozapine) PS ORAL 112.5 MG, Professional ORAL Risperdal (Risperidone) SS Prozac C Cogentin C Benadryl C Date:11/23/99ISR Number: 3406741-7Report Type:Periodic Company Report #USA/98/02405/LEX Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril (Clozapine) PS ORAL 750 MG, ORAL Initial or Prolonged Phosphokinase Increased Professional Risperdal Required Dysphagia (Risperidone) SS ORAL 2 MG, ORAL Intervention to Leukocytosis Sporanox C Prevent Permanent Muscle Contractions Clonidine C Impairment/Damage Involuntary Myalgia Pharyngitis Date:11/24/99ISR Number: 3408994-8Report Type:Expedited (15-DaCompany Report #JRFBEL1999001602 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Haldol Decanoate Hospitalization - Phosphokinase Increased Health (Unspecified) Initial or Prolonged Blood Creatinine Professional (Haloperidol Required Increased Decanoate) PS INTRAMUSCULAR 50 MG, 1 IN 1 Intervention to Blood Urea Increased MONTH (S), IM Prevent Permanent Immobile Risperidone Impairment/Damage Myoglobinuria (Unspecified) Oral Intake Reduced (Risperidone) SS ORAL MG, DAILY, Paralysis ORAL Pyrexia Rhabdomyolysis Date:11/26/99ISR Number: 3408876-1Report Type:Expedited (15-DaCompany Report #JRFUSA1999003767 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Risperdal Depression Professional (Unspecified) Dyspnoea (Risperidone) PS ORAL ORAL Date:11/26/99ISR Number: 3408880-3Report Type:Expedited (15-DaCompany Report #JRFBEL1999001902 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Risperidone (Tablet) Initial or Prolonged Syndrome Health (Risperidone) PS ORAL MG, DAILY, Water Intoxication Professional ORAL 22-Feb-2006 08:20 AM Page: 671 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/99ISR Number: 3408914-6Report Type:Expedited (15-DaCompany Report #JRFUSA1999001888 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Haematocrit Decreased Health Risperdal (Tablet) Haemoglobin Abnormal Professional (Risperidone) PS ORAL 1 IN 1 Hepatic Cirrhosis DAY(S), ORAL; Hepatic Function Abnormal 0.5 MG, 1IN Platelet Disorder 1 DAY(S), Red Blood Cell ORAL Abnormality Depakote (Valproate Splenomegaly Semisodium) SS ORAL 675 MG, Weight Decreased DAILY, ORAL White Blood Cell Disorder Clonazepam (Clonazepam) SS ORAL ORAL Synthroid (Levothyroxine Sodium) C Benadryl (Diphenhydramine Hydrochloride) C Colace (Docusate Sodium) C Date:11/26/99ISR Number: 3408918-3Report Type:Expedited (15-DaCompany Report #JRFBEL1999001747 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperidone(Unspecif Choking Health ied) (Risperidone) PS ORAL MG, DAILY, Dyskinesia Professional ORAL Epilepsy Haloperidol Injury Asphyxiation (Haloperidol) SS ORAL MG, DAILY, Stupor ORAL Vomiting Sodium Valproate (Valproic Acid) SS ORAL MG, DAILY, ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS ORAL MG, DAILY, ORAL Carbocisteine (Carbocisteine) C Polaramine (Dexchlorpheniramine Maleate) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Flunitrazepam (Flunitrazepam) C Bacampicillin Hydrochloride (Bacampicillin Hydrochloride) C Teprenone (Teprenone) C Lithium Carbonate (Lithium Carbonate) C 22-Feb-2006 08:20 AM Page: 672 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clonazepam (Clonazepam) C Date:11/26/99ISR Number: 3408921-3Report Type:Expedited (15-DaCompany Report #JRFBEL1999001775 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Risperidone(Tablet) Hospitalization - Depressed Level Of Health (Risperidone) PS ORAL MG, DAILY, Initial or Prolonged Consciousness Professional ORAL Dysphagia Amezinium Gastrointestinal Metilsulfate Haemorrhage (Amezinium Haematemesis Metilsulfate) C Hepatic Cirrhosis Sennoside Hepatic Encephalopathy (Sennosides) C Tremor Magnesium Oxide (Magnesium Oxide) C Ursodesoxycholic Acid (Tauroursodesoxychol ic Acid) C Diazepam (Diazepam) C Sodium Valproate (Valproate Sodium) C Biperden Hydrochloride (Biperiden Hydrochloride) C Cisapride (Cisapride) C Brotizolam (Brotizolam) C Amantadine Hydrochloride (Amantadine Hydrochloride) C Lactulose (Lactulose) C Kanamycin Monosulfate (Kanamycin) C Furosemide (Furosemide) C Spironolactone (Spironolactone) C Human Serum Albumin (Human Albumin) C Date:11/26/99ISR Number: 3409847-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999001747 Age:19 YR Gender:Female I/FU:I Outcome PT Death Cardio-Respiratory Arrest Choking Dyskinesia Epilepsy Injury Asphyxiation Stupor 22-Feb-2006 08:20 AM Page: 673 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tongue Disorder Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Haloperidol Health (Unspecified) Professional (Haloperidol) PS ORAL MG, DAILY, ORAL Risperidone (Unspecified) (Risperidone) SS ORAL NG, DAILY, ORAL Sodium Valproate (Valproic Acid) SS ORAL MG, DAILY, ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS ORAL MG, DAILY, ORAL Carbocisteine (Carbocisteine) C Polaramine (Dexchlorpheniramine Maleate) C Biperiden Hydrochloride (Hydrochloride (Biperiden Hydrochloride) C Flunitrazepam (Flunitrazepam) C Bacampicillin Hydrochloride (Bacampicillin Hydrochloride) C Teprenone (Teprenone) C Lithium Carbonate (Lithium Carbonate) C Clonazepam (Clonazepam) C Date:11/26/99ISR Number: 3409945-2Report Type:Expedited (15-DaCompany Report #I/99/00001/MEL Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aseptic Necrosis Bone Foreign Mellerette Required Health (Thioridazine Intervention to Professional Hydrochloride) PS ORAL 45MG ORAL Prevent Permanent Seroxat (Parocetine Impairment/Damage Hydrochloride) SS ORAL 20MG ORAL Belivon (Risperidone) SS ORAL .5MG ORAL 22-Feb-2006 08:20 AM Page: 674 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/99ISR Number: 3410198-XReport Type:Expedited (15-DaCompany Report #JAKY042873 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Foreign Risperidone Phosphokinase Increased Literature (Unspecified) Cyanosis Health (Risperidone) PS ORAL MG, DAILY, Headache Professional ORAL Hyperhidrosis Sulpiride Liver Function Test (Sulpiride) C Abnormal Myalgia Myoglobin Blood Increased Neuroleptic Malignant Syndrome Pyrexia Date:11/26/99ISR Number: 3410199-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999001942 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aseptic Necrosis Bone Foreign Risperidone Health (Unspecified) Professional (Risperidone) PS ORAL MG, DAILY, ORAL Seroxat (Paroxetine Hydrochloride) SS ORAL MG, DAILY, ORAL Mellerette (Thioridazine) SS ORAL MG, DAILY, ORAL Date:11/26/99ISR Number: 3410200-5Report Type:Expedited (15-DaCompany Report #JAOCAN1999000320 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Risperdal (1 Mg Tourette'S Disorder Health Tablet) Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Luvox (Fluvoxamine Maleate) SS ORAL ORAL Date:12/01/99ISR Number: 3411128-7Report Type:Direct Company Report # Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drooling Risperdal Intervention to Speech Disorder 2mg-Janssen PS Janssen 2MG TID Prevent Permanent Tongue Disorder Impairment/Damage Date:12/01/99ISR Number: 3412307-5Report Type:Expedited (15-DaCompany Report #JAOCAN1999000488 Age:53 YR Gender:Female I/FU:I Outcome PT Other Diabetes Insipidus Dyskinesia 22-Feb-2006 08:20 AM Page: 675 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Polydipsia Polyuria Report Source Product Role Manufacturer Route Dose Duration Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Luvox (Fluvoxamine Maleate) C Valproic Acid (Valproic Acid) C Lamictal (Lamotrigine) C Date:12/01/99ISR Number: 3412308-7Report Type:Expedited (15-DaCompany Report #JACGBR1999000498 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arterial Occlusive Foreign Risperdal Disease Consumer (Unspecified) Eye Disorder (Risperidone) PS ORAL ORAL Retinal Disorder Steroids C Scotoma Antihistamines (Antihistamines) C Date:12/01/99ISR Number: 3412309-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999001902 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperidone (Tablet) Initial or Prolonged Phosphokinase Increased Health (Risperidone) PS ORAL MG, DAILY, Coma Professional ORAL Hypertonia Flunitrazepam Hyponatraemia (Flunitrazepam) SS ORAL MG, DAILY, Muscle Rigidity ORAL Neuroleptic Malignant Pantenthine Syndrome (Pantethine) C Nystagmus Barnidipine Polydipsia Hydrochloride Pupillary Reflex Impaired (Barnidipine) C Pyrexia Alosenn (Alosenn) C Vomiting Water Intoxication Date:12/03/99ISR Number: 3413322-8Report Type:Direct Company Report # Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Amenorrhoea Consumer Risperdal 2 Mg Am, Required Ovarian Cyst 3mg Pm, Depakote Intervention to Weight Increased 125mg Am, 500mg Pm Prevent Permanent Also Klowpin 0.5mg, Impairment/Damage Doxepin 50 Mg, PS RISPERDAL 2MGAM,3MGPM Depakote 125mg Am 500mg Pm SS 125MG AM, 500MG PM Klonopin 0.5mg SS 0.5MG 22-Feb-2006 08:20 AM Page: 676 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Doxepin 50mg SS 50MG Olanzapine 5mg SS 5MG Mellarill 50 To 100mg SS 50 TO 100MG Progestin C Date:12/08/99ISR Number: 3416309-4Report Type:Expedited (15-DaCompany Report #JRFBEL1999001988 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Ageusia Foreign Risperdal Difficulty In Walking (Unspecified) Dry Mouth (Risperidone) PS ORAL ORAL 5 YR Emotional Disorder Joint Stiffness Motor Dysfunction Palpitations Psychotic Disorder Date:12/08/99ISR Number: 3417123-6Report Type:Expedited (15-DaCompany Report #JRFUSA1999003853 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Consumer Risperdal (1 Mg Initial or Prolonged Decubitus Ulcer Tablet) Hyperhidrosis (Risperidone) PS ORAL 0.5 MG, 2 IN Muscle Rigidity 1 DAY(S), Neuroleptic Malignant ORAL Syndrome Unspecified Urinary Incontinence Antihypertensive (Antihypertensive) C Estrace (Estradiol) C Glucotrol (Glipizide) C Thyroid (Thyroid) C Date:12/08/99ISR Number: 3417124-8Report Type:Expedited (15-DaCompany Report #JRFUSA1999003934 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:12/09/99ISR Number: 3417829-9Report Type:Expedited (15-DaCompany Report #HQ7484106DEC1999 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Health Efexor (Venlafaxine Initial or Prolonged Fluctuation Professional Hydrochloride) PS ORAL 375.5 MG 2X Other Confusional State PER 1 DAY 3 DAY Disorientation Efexor (Venlafaxine Drug Withdrawal Syndrome Hydrochloride) SS ORAL 75 MG 2X PER Hypomania 1 DAY 10 DAY Speech Disorder Efexor (Venlafaxine Hydrochloride) SS ORAL 150 MG 2X PER 1 DAY 38 DAY 22-Feb-2006 08:20 AM Page: 677 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Efexor (Venlafaxine Hydrochloride) SS ORAL 75 MG 2X PER 1 DAY 3 DAY Risperidone (Risperidone) SS ORAL 1-2 MG DAILY Carbamazepine C Lorazepam C Flurazepam C Date:12/09/99ISR Number: 3418032-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999001989 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myositis Foreign Risperidone Initial or Prolonged Neuroleptic Malignant Literature (Unspecified ) Syndrome Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Clocapramine Dihydrochloride (Clocapramine Hydrochloride) SS DAILY Mosapramine Hydrochloride (Mosapramine Hydrochloride) SS DAILY Biperiden Hydrochloride (Biperiden Hydrochloride) SS DAILY Date:12/09/99ISR Number: 3418034-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999001990 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Risperidone (Tablet) Initial or Prolonged Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Sulpiride C Haldol C Mianserin C Biperiden Hydrochloride C Chlorpromazine And Preparations C Promethazine Hydrochloride C Phenobarbital C Flunitrazepam C Alosenn C Sennoside C Protoporphyrin Disodium C Allopurinol C Magnesium Oxide C Cisapride C Inosine C Etilefrine Hydrochloride C 22-Feb-2006 08:20 AM Page: 678 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/99ISR Number: 3417884-6Report Type:Direct Company Report # Age:22.8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Health Seroquel PS 150MG QHS Initial or Prolonged Professional Risperdal SS 3MG QHS Date:12/10/99ISR Number: 3418852-0Report Type:Expedited (15-DaCompany Report #PRIUSA1999006850 Age:39 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Ultram (50 Mg Intentional Overdose Health Tablet) (Tramadol Professional Hydrochloride) PS ORAL ORAL Risperdal (Unspecified) (Risperidone) SS ORAL ORAL Amitriptyline (Amitriptyline) SS ORAL ORAL Date:12/10/99ISR Number: 3418902-1Report Type:Direct Company Report # Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Risperidone PS Initial or Prolonged Professional Date:12/13/99ISR Number: 3421548-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999001989 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Foreign Risperidone Initial or Prolonged Back Pain Literature (Risperidone) PS ORAL MG, DAILY, Disability Blood Calcium Increased Health ORAL Required Blood Creatine Professional Clocapramine Intervention to Phosphokinase Increased Dihydrochloride Prevent Permanent Calcinosis (Clocapramine Impairment/Damage Convulsion Hydrochloride) SS MG, DAILY Dysphagia Mosapramine Dyspnoea Hydrochloride Gait Disturbance (Mosapramine Immobile Hydrochloride) SS MG, DAILY Insomnia Biperiden Malaise Hydrochloride Muscle Rigidity (Biperiden Myositis Hydrochloride) SS MG, DAILY Neuroleptic Malignant Dantrolene Sodium Syndrome (Dantrolene Sodium) SS MG, DAILY Oral Intake Reduced Pyrexia Schizophrenia Tremor Urinary Retention 22-Feb-2006 08:20 AM Page: 679 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/99ISR Number: 3422797-XReport Type:Expedited (15-DaCompany Report #JACAN16942 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autonomic Nervous System Foreign Risperidone (Tablet) Initial or Prolonged Imbalance Health (Risperidone) PS (1 MG 2 DAILY Blood Creatine Professional 15-APR-98) : Phosphokinase Increased Modecate (Solution) Neuroleptic Malignant (Fluphenazine-Decano Syndrome ate) SS (18.75 MG 1 Pyrexia 2WEEKLY Renal Failure 15-APR-98) : Rhabdomyolysis START AND STOP DATES Rivotril (Tablet) Clonazepam C Date:12/13/99ISR Number: 3422799-3Report Type:Expedited (15-DaCompany Report #JACGER1999000847 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal (Tablet) Initial or Prolonged Phosphokinase Increased Health (Risperidone) PS ORAL MG, DAILY, Hypothermia Professional ORAL Myoglobinuria Date:12/14/99ISR Number: 3420700-XReport Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Risperdal 2mg PS ORAL 2MG PO Initial or Prolonged Asthenia Dizziness Vomiting Date:12/16/99ISR Number: 3423461-3Report Type:Expedited (15-DaCompany Report #JRFBEL1999002093 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Red Blood Cell Count Foreign Risperdal Decreased Health (Unspecified) Professional (Risperidone) PS DAILY, UTERINE Date:12/17/99ISR Number: 3424640-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999001902 Age:44 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Coma Hypertonia Hyponatraemia Muscle Rigidity Mydriasis Neuroleptic Malignant Syndrome Nystagmus 22-Feb-2006 08:20 AM Page: 680 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pupillary Reflex Impaired Pyrexia Vomiting Report Source Product Role Manufacturer Route Dose Duration Water Intoxication Foreign Risperidone (Tablet) Health (Risperidone) PS ORAL MG DAILY ORAL Professional Flunitrazepam (Flunitrazepam) SS ORAL MG DAILY ORAL Sennoside (Sennosides) SS ORAL ORAL Pantethine (Pantethine) C Barnidipine Hydrochloride (Barnidipine) C Alosenn (Aslosenn) C Date:12/17/99ISR Number: 3424644-9Report Type:Expedited (15-DaCompany Report #JRFUSA1999004310 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Consumer Risperdal Initial or Prolonged Bronchitis (Unspecified) Cerebrovascular Accident (Risperidone) PS Date:12/17/99ISR Number: 3424647-4Report Type:Expedited (15-DaCompany Report #JRFBEL1999002076 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperidone (Tablet) Cardiomegaly Health (Risperidone) PS ORAL 6MG DAILY Congestive Cardiomyopathy Professional ORAL Hepatomegaly Sulpiride Sudden Death (Sulpiride) C Biperiden Hydrochloride (Biperiden) C Vegetamin A (Vegetamin A) C Nitrazepam (Nitrazepam) C Triazolam (Triazolam) C Flunitrazepam (Flunitrazepam) C Brotizolam (Brotizolam) C Pantethine (Panterhine) C Magnesium Oxide (Magnesium Oxide) C Date:12/17/99ISR Number: 3424649-8Report Type:Expedited (15-DaCompany Report #JRFUSA1999004259 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paralysis Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 681 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/17/99ISR Number: 3424651-6Report Type:Expedited (15-DaCompany Report #JACFRA1999000498 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Polydipsia Foreign Risperdal (Tablet) Health (Risperidone) PS ORAL MG DAILY ORAL Professional Company Representative Date:12/17/99ISR Number: 3425372-6Report Type:Expedited (15-DaCompany Report #9940425 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Zoloft Tablets PS ORAL 10.00 MG Cardiac Arrest Professional TOTAL:DAILY:O Drug Interaction Company RAL Drug Level Above Representative Amlodipine SS ORAL 5.00 MG Therapeutic TOTAL:DAILY:O Drug Toxicity RAL Hepatic Congestion Risperidone SS ORAL 6.00 MG Liver Disorder TOTAL:BID:ORA Myocardial Fibrosis L Overdose Cisapride SS ORAL 40.00 MG Pulmonary Congestion TOTAL:QID:ORA Sudden Death L Toxicologic Test Abnormal Prilosec C Urinary Incontinence Hydrochlorothiazide C Cotrimoxazole C Bactrim Ds C Date:12/17/99ISR Number: 3425518-XReport Type:Expedited (15-DaCompany Report #10130557 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Questran Drug Interaction Health (Cholestyramine) PS ORAL ORAL 2 MON Psychotic Disorder Professional Sulpiride SS 400 Other MILLIGRAM, 2/1 DAY Risperidone SS Date:12/20/99ISR Number: 3425817-1Report Type:Expedited (15-DaCompany Report #JAOCAN1999000544 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Risperdal Initial or Prolonged Congestive Health (Unspecified) Pulmonary Oedema Professional (Risperidone) PS ORAL MG, DAILY Date:12/20/99ISR Number: 3425917-6Report Type:Expedited (15-DaCompany Report #JACGBR1999000355 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Risperdal Coma Health (Unspecified) Muscle Rigidity Professional (Risperidone) PS ORAL Oral Intake Reduced 22-Feb-2006 08:20 AM Page: 682 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/99ISR Number: 3425940-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999001990 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Risperidone (Tablet) Initial or Prolonged Flatulence Health (Risperidone ) PS ORAL MG, DAILY, Ileus Paralytic Professional ORAL Schizophrenia Haldol (Unspecified) (Haloperidol) SS ORAL MG, DAILY, ORAL Chlorpromazine And Preparations (Chlorpromazine) SS ORAL MG, DAILY, ORAL Sulpiride (Sulpiride) C Mianserin Hydrochloride (Mianserin Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Promethazine Hydrochloride (Promethazine Hydrochloride) C Phenobarbital (Phenobarbital) C Flunitrazepam (Flunitrazepam) C Alosenn (Alosenn) C Sennoside (Sennosides) C Protoporphyrin Disodium (Protoporphyrin Disodium) C Allopurinol (Allopurinol) C Etilefrine Hydrochloride (Etilefrine Hydrochloride) C Magnesium Oxide (Magnesium Oxide) C Cisapride (Unspecified) (Cisapride) C Inosine (Inosine) C Date:12/20/99ISR Number: 3426044-4Report Type:Direct Company Report # Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Seroquel 100mg- Zeneca PS Zeneca 1T QAM 2T QHS Risperdal 3mg SS 1T QID Depakene C Ativan C 22-Feb-2006 08:20 AM Page: 683 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/99ISR Number: 3426075-4Report Type:Expedited (15-DaCompany Report #JACGBR1999000356 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypersensitivity Foreign Risperdal Oral Intake Reduced Health (Risperidone) PS ORAL ORAL Professional Date:12/22/99ISR Number: 3428278-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999001990 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Haldol (Unspecified) Initial or Prolonged Flatulence Health (Haloperidol) PS ORAL MG, DAILY, Ileus Paralytic Professional ORAL Risperidone (Tablet) (Risperidone) SS MG, DAILY, ORAL Chlorpromazine And Preprations (Chlorpromazine) SS ORAL MG, DAILY, ORAL Sulpiride C Mianserin Hydrochloride C Biperiden Hydrochloride C Promethazine Hydrochloride C Phenobarbital C Flunitrazepam C Alosenn C Sennoside C Protoporphyrin Disodium C Allopurinol C Etilefrine Hydrochloride C Magnesium Oxide C Magnesium Oxide C Cisapride C Inosine C Date:12/22/99ISR Number: 3429151-5Report Type:Periodic Company Report #A001-002-003644 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Aricept (Donepezil) PS ORAL PER ORAL Hallucination Lorazepam Hypertonia (Lorazepam) SS Oedema Peripheral Risperidone Periorbital Oedema (Risperidone) SS Date:12/23/99ISR Number: 3431007-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999002076 Age:28 YR Gender:Female I/FU:F Outcome PT Death Cardiac Failure Cardiomegaly 22-Feb-2006 08:20 AM Page: 684 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Congestive Cardiomyopathy Hepatomegaly Sudden Death Report Source Product Role Manufacturer Route Dose Duration Foreign Risperidone Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Other Sulpiride (Sulpiride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Vegetamin A (Vegetamin A) C Nitrazepam (Nitrazepam) C Triazolam (Triazolam) C Flunitrazepam (Flunitrazepam) C Brotizolam (Brotizolam) C Pantethine (Pantethine) C Magnesium Oxide (Magnesium Oxide) C Date:12/23/99ISR Number: 3431012-2Report Type:Expedited (15-DaCompany Report #JRFUSA1999004307 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Activated Partial Health Risperdal Thromboplastin Time Professional (Risperidone) PS ORAL 8 MG, 1 IN 1 Prolonged DAY(S), ORAL Antibody Test Positive Depakote (Valproate Blood Fibrinogen Semisodium) C Decreased Cogentin Muscle Haemorrhage (Benzatropine Thrombocytopenia Mesilate) C Date:12/27/99ISR Number: 3431386-2Report Type:Expedited (15-DaCompany Report #JAUSA25236 Age:42 YR Gender:Male I/FU:F Outcome PT Required Amnesia Intervention to Aneurysm Prevent Permanent Blood Pressure Increased Impairment/Damage Chest Pain Circulatory Collapse Dyskinesia Embolism Haemoptysis Hearing Impaired Heart Rate Irregular Hypoaesthesia Liver Function Test Abnormal Monoparesis Pancreatic Disorder 22-Feb-2006 08:20 AM Page: 685 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sperm Count Decreased Testicular Pain Tooth Disorder Report Source Product Role Manufacturer Route Dose Duration Urine Analysis Abnormal Consumer Risperdal (Tablet) Visual Acuity Reduced Health (Risperidone) PS ORAL 1 MG, 2 IN 1 Weight Increased Professional DAY(S),ORAL Betoptic (Betaxolol Hydrochloride) SS OPHTHALMIC OPTHA Pravachol (Pravastatin) C Selenium Sulfate (Selenium Sulfide) C Lotrisone Cream (Lotrisone) C Niacin (Nicotinic Acid) C Vitamin E (Tocopherol) C Tylenol (Paracetamol) C Ibruprofen (Ibuprofen) C Fish Oil Concentrate (Fish Oil) C Maalox (Maalox) C Date:12/27/99ISR Number: 3431390-4Report Type:Expedited (15-DaCompany Report #JACGER1999000920 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lower Respiratory Tract Foreign Risperdal (Tablet) Infection Health (Risperidone) PS ORAL MG, DAILY, Pleural Calcification Professional ORAL Pleural Effusion Date:12/27/99ISR Number: 3431521-6Report Type:Expedited (15-DaCompany Report #JRFBEL1999002142 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Risperdal (2 Mg Initial or Prolonged Consciousness Health Tablet) Required Dysphagia Professional (Risperidone) PS ORAL MG, DAILY, Intervention to Epilepsy ORAL Prevent Permanent Gait Disturbance Imovane (Zopiclone) C Impairment/Damage Hallucination, Auditory Stesolid (Diazepam) C Muscle Rigidity Akineton (Biperiden Neuroleptic Malignant Hydrochloride) C Syndrome Dantrium (Dantrolene Obsessive-Compulsive Sodium) C Disorder Pravidel Pain (Bromocriptine Parkinsonism Mesilate) C Poverty Of Speech Pyrexia Sepsis Tachycardia Tremor 22-Feb-2006 08:20 AM Page: 686 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/99ISR Number: 3431522-8Report Type:Expedited (15-DaCompany Report #JRFUSA1999004513 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Consumer Risperdal (Tablet) Dyspnoea (Risperidone) PS ORAL ORAL Nightmare Nardil (Phenelzine Sleep Paralysis Sulfate) C Date:12/27/99ISR Number: 3431572-1Report Type:Expedited (15-DaCompany Report #JRFUSA1999002817 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Basal Cell Carcinoma Health Risperdal (1 Mg Intervention to Skin Lesion Professional Tablet) Prevent Permanent (Risperidone) PS ORAL 1 MG, 1 IN 1 Impairment/Damage DAY(S), ORAL Date:12/30/99ISR Number: 3435085-2Report Type:Expedited (15-DaCompany Report #JRUSA1999004522 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Risperdal (Tablet) Initial or Prolonged Hyponatraemia Professional (Risperidone) PS ORAL 3 MG, PRN, Hypothyroidism ORAL Medication Error Date:12/30/99ISR Number: 3435089-XReport Type:Expedited (15-DaCompany Report #JRFBE1999002226 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Foreign Risperidone Health (Unspecified) Professional (Risperidone) PS ORAL MG, DAILY, ORAL Trihexyphenidyl Hcl (Trihexyphenidyl Hydrochloride) C Date:01/03/00ISR Number: 3436040-9Report Type:Expedited (15-DaCompany Report #JACGBR1999000598 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Foreign Risperdal Stevens-Johnson Syndrome Health (Unspecified) Professional (Risperidone) PS MG, DAILY, Carbamazepine (Carbamazepine) C Venlafazine (Venlafaxine) C Date:01/03/00ISR Number: 3436042-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999002076 Age:28 YR Gender:Female I/FU:F Outcome PT Death Apnoea Cardiac Failure 22-Feb-2006 08:20 AM Page: 687 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Congestive Cardiomyopathy Electrocardiogram Abnormal Report Source Product Role Manufacturer Route Dose Duration Hepatic Congestion Foreign Risperidone (Tablet) Hepatic Rupture Health (Risperidone) PS ORAL MG, DAILY, Hepatomegaly Professional ORAL Hypertrophic Obstructive Biperiden Cardiomyopathy Hydrochloride Intra-Abdominal (Biperiden) C Haemorrhage Vegetamin A Mydriasis (Vegatamin A) C Sudden Death Brotizolam (Brotizolam) C Magnesium Oxide (Magnexium Oxide) C Pantethine (Pantethine) C Nitrazepam (Nitrazepam) C Triazolam (Triazolam) I Date:01/06/00ISR Number: 3438685-9Report Type:Direct Company Report # Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Serotonin Syndrome Risperidone PS N.A. Sertraline SS Dextromethorphan C 2 TEASPOONS Q PM Date:01/07/00ISR Number: 3440004-9Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Clonazepam PS .5 Q AM + 2 Initial or Prolonged Drug Toxicity Professional HS Dysarthria Risperidone SS 3MG Q AM 4 MG Fall HS Sedation Benadryl C Date:01/10/00ISR Number: 3441616-9Report Type:Expedited (15-DaCompany Report #JRFUSA1999004259 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paralysis Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:01/10/00ISR Number: 3441617-0Report Type:Expedited (15-DaCompany Report #JRFUSA1999004157 Age:9 YR Gender:Female I/FU:I Outcome PT Ecchymosis Epistaxis Platelet Count Decreased Purpura 22-Feb-2006 08:20 AM Page: 688 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Thrombocytopenia Report Source Product Role Manufacturer Route Dose Duration Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAY(S), ORAL Depakote (Valproate Semisodium) C Eskalith Cr (Lithium Carbonate) C Date:01/11/00ISR Number: 3442498-1Report Type:Direct Company Report # Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Risperidone PS Initial or Prolonged Drooling Depakote C Dysarthria Cogentin C Muscle Rigidity Clonazepam C Parkinsonism Tremor Trismus Date:01/12/00ISR Number: 3443399-5Report Type:Expedited (15-DaCompany Report #JACGER2000000014 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pulmonary Oedema Foreign Risperdal ( 1 Mg Health Tablet) Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Date:01/12/00ISR Number: 3443401-0Report Type:Expedited (15-DaCompany Report #JRFUSA1999002960 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Health Risperdal Initial or Prolonged Complete Professional (Unspecified) Required Bradycardia (Risperidone) PS ORAL 5 MG, 1 IN 1 Intervention to Depressed Level Of NIGHT(S), Prevent Permanent Consciousness ORAL Impairment/Damage Risperdal (Unspecified) (Risperidone) SS Inderal C Inderal C Date:01/12/00ISR Number: 3443404-6Report Type:Expedited (15-DaCompany Report #JRFBEL1999001775 Age:51 YR Gender:Male I/FU:F Outcome PT Death Condition Aggravated Hospitalization - Depressed Level Of Initial or Prolonged Consciousness Gastrointestinal 22-Feb-2006 08:20 AM Page: 689 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemorrhage Haematemesis Hepatic Cirrhosis Hepatic Encephalopathy Report Source Product Role Manufacturer Route Dose Duration Tremor Foreign Risperidone (Tablet) Health (Risperidone) PS ORAL MG, DAILY,M Professional ORAL` Risperidone (Tablet) (Risperidone) SS Cisapride C Amezinium C Cisapride C Amezinium C Sennoside C Magnesium Oxide C Ursodesoxycholic Acid C Diazepam C Sodium Valproate C Biperriden Hydrochloride C Brotizolam C Amantadine Hydrochloride C Lactulose C Kanamycin Monosulfate C Furosemide C Spironolactone C Human Serum Albumin C Date:01/12/00ISR Number: 3443514-3Report Type:Expedited (15-DaCompany Report #216589 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Rivotril (Clonazepam Blood Creatine Other ) PS 1 MG 1 PER Phosphokinase Increased ONE DOSE Blood Creatine Risperidone Phosphokinase Mb (Risperidone) SS ORAL 6 MG DAILY Increased ORAL Confusional State Chlorpromazine Flushing (Chlorpromazine) SS 200 MG 1 PER Hepatic Function Abnormal ONE DOSE Liver Function Test Abnormal Neuroleptic Malignant Syndrome Tachycardia Date:01/12/00ISR Number: 3443900-1Report Type:Expedited (15-DaCompany Report #JACGER2000000025 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Risperidal Neutropenia Health (Resperidone) PS ORAL 1 MG, DAILY, Professional ORAL Tavor (Lorazepam) C 22-Feb-2006 08:20 AM Page: 690 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/12/00ISR Number: 3443901-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000000095 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Risperdal (Tablet) Initial or Prolonged Cardiac Arrest Risperidone) PS ORAL 3 MG, 2 IN 1 Required Chest Pain DAY(S), ORAL Intervention to Headache Haloperidol Prevent Permanent Parkinsonism (Haloperidol) SS ORAL 2 MG, 4 IN 1 Impairment/Damage Tachycardia DAY(S), ORAL Tremor Risperdal (Tablet) (Risperidone) SS ORAL 1.5 MG, 4 IN 1 DAY(S), ORAL Risperdal (Tablet) Risperidone) SS ORAL 7.5 MG, 1 IN 1 DAY(S), ORAL Risperdal (Tablet) (Risperidone) SS ORAL 8.5 MG, 1 IN 1 DAY(S), ORAL Ativan (Lorazepam) C Olanzapine (Olanzapine) C Date:01/12/00ISR Number: 3443902-5Report Type:Expedited (15-DaCompany Report #JRFUSA1999001399 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspartate Health Risperdal (1 Mg Required Aminotransferase Professional Tablet) Intervention to Increased (Risperidone) PS ORAL 1 MG, 2 IN 1 Prevent Permanent Blood Bilirubin Increased DAY(S), ORAL Impairment/Damage Blood Creatine Increased Ativan (Lorazepam) SS ORAL 5, TOTAL, Blood Potassium Decreased ORAL Blood Urea Increased Zoloft (Sertraline Coma Hydrochloride) SS ORAL 50 MG, 1 IN 1 Hyperglycaemia DAY(S), ORAL Pulse Absent Pyrexia Sedation Sudden Death Date:01/13/00ISR Number: 3443601-XReport Type:Expedited (15-DaCompany Report #JRFUSA2000000095 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Haloperidol Initial or Prolonged Cardiac Arrest (Haloperidol) PS ORAL 2 MG, 4 IN 1 Required Chest Pain DAY(S), ORAL Intervention to Feeling Cold Risperdal (Tablet) Prevent Permanent Headache (Risperidone) SS ORAL 3MG, 2 IN 1 Impairment/Damage Parkinsonism 1.5MG, 4IN1, Pulse Absent 7.5MG, 1IN1, Tachycardia 8.5MG, Tremor 1IN1DAY(S), Ativan (Lorazepam) C Olanzapine (Olanzapine) C 22-Feb-2006 08:20 AM Page: 691 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/00ISR Number: 3443739-7Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cough Venlafaxine PS 100 MG BID Intervention to Fluid Overload Risperidone SS 2MG BID Prevent Permanent Hyperkalaemia Albuterol C Impairment/Damage Hyponatraemia Acetaminophen C Hypovolaemic Shock Diphenhydramine C Inappropriate Doss C Antidiuretic Hormone Secretion Pleural Effusion Pulmonary Oedema Date:01/14/00ISR Number: 3444291-2Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qrs Risperdal PS SEE ITEM B5 Initial or Prolonged Complex Prolonged Ambien C Electrocardiogram Qt Premarin C Prolonged Paxil C Medication Error Overdose Date:01/18/00ISR Number: 3444736-8Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Micturition Urgency Celexa PS SEE NOTE Middle Insomnia Risperdal SS Urinary Incontinence Date:01/18/00ISR Number: 3444797-6Report Type:Direct Company Report # Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Health Risperdal ? 5mg PS NOT SURE 5MG Disturbance In Attention Professional 2X/DAY Palpitations Date:01/18/00ISR Number: 3445741-8Report Type:Expedited (15-DaCompany Report #JRFBEL1999002226 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Lactate Foreign Risperidone (Tablet) Initial or Prolonged Dehydrogenase Increased Health (Risperidone) PS ORAL MG, DAILY, Haematuria Professional ORAL Nephrotic Syndrome Trihexyphenidyl Hcl Oedema (Trihexphenidyl Proteinuria Hydrochloride) SS ORAL MG, DAILY, Rhabdomyolysis ORAL Furosemide (Furosemide) C 22-Feb-2006 08:20 AM Page: 692 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/00ISR Number: 3445194-XReport Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Nightmare Health Risperdal 1mg Professional Janssen PS Janssen ORAL RISPERDAL 1MG PO QAM Risperdal 2mg Janssen SS Janssen ORAL RISPERDAL 2MG PO QHS Date:01/21/00ISR Number: 3446235-6Report Type:Expedited (15-DaCompany Report #HQ0548918JAN2000 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Health Efexor (Venlafaxine Initial or Prolonged Mydriasis Professional Hydrochloride) PS ORAL 6000 MG Overdose Other OVERDOSE Sedation AMOUNT, ORAL 1 DAY Risperidone (Risperidone) SS ORAL 40 MG OVERDOSE AMOUNT, ORAL 1 DAY Zopiclone (Zopiclone) SS ORAL 60 MG OVERDOSE AMOUNT, ORAL 1 DAY Date:01/24/00ISR Number: 3446109-0Report Type:Direct Company Report # Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Galactorrhoea Health Risperdal PS Professional Date:01/24/00ISR Number: 3446801-8Report Type:Expedited (15-DaCompany Report #A0109367A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Wellbutrin Non-Insulin-Dependent Professional (Formulation Other Unknown) (Bupropion Hydrochloride) PS ORAL ORAL Risperidone (Formulation Unknown) (Risperidone) SS ORAL ORAL Date:01/24/00ISR Number: 3447243-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000000200 Age:13 YR Gender:Female I/FU:I Outcome PT Autonomic Nervous System Imbalance Blood Creatine Phosphokinase Increased Conjunctivitis Dehydration 22-Feb-2006 08:20 AM Page: 693 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Level Above Therapeutic Drug Toxicity Report Source Product Role Manufacturer Route Dose Duration Hypertension Health Risperdal (Tablet) Leukopenia Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 Mental Impairment DAY(S) ORAL Muscle Rigidity Seroquel (Seroquel) SS ORAL 600 MG, DAILY Neuroleptic Malignant ORAL Syndrome Loxitane (Loxapine Pyrexia Succinate) SS ORAL ORAL Lithium (Lithium) SS ORAL ORAL Synthroid (Levothyroxine Sodium) C Depakote (Valproate Semisodium) C Date:01/24/00ISR Number: 3447245-5Report Type:Expedited (15-DaCompany Report #JACGBR1999000598 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dermatitis Foreign Risperdal Malaise Health (Unspecified) Pyrexia Professional (Risperidone) PS ORAL 3 MG, 1 IN 1 Rash Erythematous NIGHT (S), Rash Maculo-Papular ORAL Stevens-Johnson Syndrome Carbamazepine Stomatitis (Carbamazepine) SS 100 MG, 1 IN 1 NIGHT (S) Carbamazepine(Carbam azepine) SS 100 MG, 3 IN 1 DAY(S) Effexor (Venlafaxine Hydrochloride) C Diazepam (Diazepam) C Date:01/24/00ISR Number: 3447477-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000000209 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Health Risperdal Initial or Prolonged Fluid Overload Professional (Risperidone) PS ORAL 2 MG, 2 IN 1 Required Hyperkalaemia DAY(S), ORAL Intervention to Hyponatraemia Venlafaxine Prevent Permanent Hypovolaemia (Venlafaxine) SS 100 MG, 2 IN Impairment/Damage Inappropriate 1 DAY(S) Antidiuretic Hormone Secretion Pleural Effusion Pulmonary Oedema Date:01/24/00ISR Number: 3447490-9Report Type:Expedited (15-DaCompany Report #JRFUSA2000000192 Age:47 YR Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:20 AM Page: 694 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Consumer Risperdal (3 Mg Breast Cancer Female Tablet) Dyskinesia (Risperidone) PS ORAL 6; 3 MG, 1 IN Hyperprolactinaemia 1 DAY(S), ORAL Nortriptyline (Nortriptyline) C Date:01/24/00ISR Number: 3447529-0Report Type:Expedited (15-DaCompany Report #JRFBEL2000000084 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticholinergic Syndrome Foreign Risperdal Initial or Prolonged Cardiac Disorder Literature (Unspecified) Required Cardiogenic Shock Health (Risperidone) PS ORAL MG, DAILY, Intervention to Coma Professional ORAL Prevent Permanent Dysuria Loxapac (Loxapine Impairment/Damage Hypotension Succinate) SS MG, DAILY Multi-Organ Failure Seresta (Oxazepam) SS Nosocomial Infection Hea (Hetastarch) SS 500 MG Palpitations Striadyne (Adenosine Pulmonary Oedema Triphosphate) SS INTRAVENOUS 40 MG, IV Rales Alvocardyl Renal Impairment (Propranolol) SS 20 MG, 1 IN 4 Sepsis HOUR (S) Syncope Tachycardia Toxicologic Test Abnormal Date:01/24/00ISR Number: 3447540-XReport Type:Expedited (15-DaCompany Report #JACGBR1999000330 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Risperidone (Tablet) Serum Ferritin Decreased Health (Risperidone) PS ORAL 3 MG, 2 IN 1 Professional DAY (S), ORAL Depixol (Flupentixol Decanoate) SS Procyclidine C Zimovane C Venlafaxine C Diazepam C Haldol Decanoate C Date:01/24/00ISR Number: 3447545-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999002226 Age:49 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Blood Lactate Dehydrogenase Increased Dysuria Eyelid Oedema Haematuria 22-Feb-2006 08:20 AM Page: 695 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nephrotic Syndrome Oedema Oliguria Report Source Product Role Manufacturer Route Dose Duration Proteinuria Foreign Risperidone (Tablet) Rhabdomyolysis Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Trihexyphenidyl Hcl SS ORAL MG, DAILY, ORAL Furosemide C Date:01/24/00ISR Number: 3447608-8Report Type:Expedited (15-DaCompany Report #JACFRA2000000021 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Foreign Risperdal PS ORAL 0.25 MG, 2 IN Initial or Prolonged Thrombocytopenic Purpura Health 1 DAY (S), Professional ORAL Company Depamide Representative (Valpromide) C Date:01/24/00ISR Number: 3447613-1Report Type:Expedited (15-DaCompany Report #JRFBEL1999001890 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dehydration Foreign Risperidone Hospitalization - Drug Interaction Health (Risperidone) PS ORAL MG, DAILY, Initial or Prolonged Hypotension Professional ORAL Required Neutropenia Denopamine Intervention to Shock (Denopamine) C ORAL TABLE,DAILY, Prevent Permanent ORAL Impairment/Damage Morphine Hydrochloride (Morphine Hydrochloride0 C Hicaliq (Tm) (Hicaliq) C Sulfamethoxazole/Tri methoprikm (Bactrim) C Famotidine (Famotidine) C Amphotericin B(Amphotericin B) C Ciprofloxacin Hydrochloride (Ciprofloxacin Hydrochloride) C Brotizolam (Brotizolam) C Flunitrazepam (Flunitrazepam) C Lenograstim (Lenograstim) C Imipenem/Cilastatin Sodium (Primaxin) C 22-Feb-2006 08:20 AM Page: 696 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/24/00ISR Number: 3447614-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000000112 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Basophil Count Increased Foreign Risperidone Eosinophil Count Health (Risperidone) PS ORAL ORAL Increased Professional Fatigue Lethargy Liver Function Test Abnormal Monocyte Count Increased Tardive Dyskinesia Date:01/24/00ISR Number: 3447635-0Report Type:Expedited (15-DaCompany Report #JRFBEL2000000104 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blepharospasm Literature Risperidone Eyelid Function Disorder Health (Unspecified) Lymphoedema Professional (Risperidone) PS MG, DAILY Stress Thioridazine Visual Disturbance (Thioridazine0 SS MG, DAILY Date:01/24/00ISR Number: 3447637-4Report Type:Expedited (15-DaCompany Report #JRFUSA2000000224 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Above Health Risperdal Initial or Prolonged Therapeutic Professional (Unspecified) Required Miosis (Risperidone) PS ORAL 1 IN 1 Intervention to Sedation TIME(S), ORAL Prevent Permanent Aspirin Bayer Am Impairment/Damage (Acetylsalicylic Acid) SS ORAL 1 IN 1 TIME(S), ORAL Zoloft (Sertraline Hydrochloride) SS ORAL 1 IN 1 TIME(S), ORAL Depakote (Valproate Semisodium) SS ORAL 1 IN 1 TIME(S), ORAL Date:01/24/00ISR Number: 3447904-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000000097 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Sodium Decreased Foreign Risperdal Hospitalization - Circulatory Collapse Health (Unspecified) Initial or Prolonged Hyponatraemia Professional (Risperidone) PS ORAL MG, DAILY, Liver Function Test ORAL Abnormal Orphendarine Citrate (Orphenadrine Citrate) SS ORAL ORAL Latanoprost (Latanoprost) C Frusemide (Furosemide) C Roxithromycin 22-Feb-2006 08:20 AM Page: 697 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Roxithromycin) C Date:01/26/00ISR Number: 3454496-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999002226 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperidone (Tablet) Initial or Prolonged Phosphokinase Increased Health (Risperidone) PS ORAL MG, DAILY, Blood Lactate Professional ORAL Dehydrogenase Increased Trihexyphenidyl Hcl Dysuria (Trihexyphenidyl Eyelid Oedema Hydrochloride) SS ORAL MG, DAILY, Haematuria ORAL Nephrotic Syndrome Furosemide Oedema (Furosemide) C Oliguria Proteinuria Rhabdomyolysis Date:01/28/00ISR Number: 3448283-9Report Type:Expedited (15-DaCompany Report #S00-GER-00037-01 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Cipramil (Citalopram Initial or Prolonged Akathisia Health Hydrobromide) PS ORAL 20 MG QD PO Anxiety Professional Cipramil (Citalopram Insomnia Hydrobromide) SS ORAL 40 MG QD PO Cipramil (Citalopram Hydrobromide) SS ORAL 20 MG QD PO Risperdal (Risperidone) SS ORAL 2 MG QD PO Risperdal (Risperidone) SS ORAL 4 MG QD PO Risperdal (Risperidone) SS ORAL 6 MG QD PO Risperdal (Risperidone) SS ORAL 4 MG QD PO Risperdal (Risperidone) SS ORAL 3 MG QD PO Dociton C Date:01/31/00ISR Number: 3448556-XReport Type:Expedited (15-DaCompany Report #A001638 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anxiety Consumer Zoloft Tablets PS 50.00 MG Intervention to Aphasia TOTAL:DAILY Prevent Permanent Decreased Activity Celebrex SS Impairment/Damage Depression Risperdal SS Dizziness Quinine Sulfate C Haematochezia Prilosec C Haemoglobin Decreased Furosemide C Hallucination Captopril C Lethargy Toprol Xl C Oral Intake Reduced 22-Feb-2006 08:20 AM Page: 698 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/00ISR Number: 3448631-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000000163 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Foreign Risperdal (1 Mg Initial or Prolonged Decubitus Ulcer Health Tablet) Sedation Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY(S), ORAL Atenololum (Atenolol) C Madopar (Madopar) C Strumazol (Thiamazole) C Date:01/31/00ISR Number: 3449078-2Report Type:Expedited (15-DaCompany Report #JRFBEL2000000155 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Flutter Foreign Risperidone (3 Mg Initial or Prolonged Dystonia Literature Tablet) Required Electrocardiogram Qt Health (Risperidone) PS ORAL ORAL 270MG,1 Intervention to Corrected Interval Professional IN 1 TIME Prevent Permanent Prolonged Benzodiazepine C Impairment/Damage Extrapyramidal Disorder Hypotension Intentional Overdose Lethargy Miosis Muscle Spasms Pyrexia Sinus Bradycardia Stupor Supraventricular Tachycardia Date:01/31/00ISR Number: 3449081-2Report Type:Expedited (15-DaCompany Report #JACFRA2000000021 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Risperdal (1 Mg Initial or Prolonged Increased Health Tablet) Idiopathic Professional (Risperidone) PS ORAL 0.25 MG, 2 IN Thrombocytopenic Purpura Company 1 DAY(S), Representative ORAL Depamide (Valpromide) C Aldactone 50 (Spironolactone) C Medrol (Methylprednisolone) C Tercian (Cyamemazine ) C Date:02/01/00ISR Number: 3449833-9Report Type:Expedited (15-DaCompany Report #JRFUSA2000000315 Age:49 YR Gender:Male I/FU:I Outcome PT Death Emphysema Headache 22-Feb-2006 08:20 AM Page: 699 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sudden Death Report Source Product Role Manufacturer Route Dose Duration Health Haldol (Injection) Professional (Haloperidol) PS ORAL 150 MG, 1 IN 1 MONTH(S), ORAL Risperdal (4 Mg Tablet) (Risperidone) SS ORAL 4 MG, 1 IN 1 DAY(S), ORAL Date:02/01/00ISR Number: 3449864-9Report Type:Expedited (15-DaCompany Report #JRFUSA1999001892 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Risperdal (Tablet) Leukopenia Professional (Risperidone) PS ORAL 2 MG, 2 IN 1 Neutropenia DAY(S), ORAL Thrombocytopenia 3 MG, 1 IN 1 DAY(S), ORAL 2 MG, 1IN 1 Neurontin (Gabapentin) C Vitamin E (Tocopherol) C Date:02/03/00ISR Number: 3450738-8Report Type:Direct Company Report #USP 081234 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Risperdal PS Janssen Remeron (Mirtazapine) SS Organon Date:02/03/00ISR Number: 3451446-XReport Type:Expedited (15-DaCompany Report #JACFRA2000000060 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Risperdal (Tablet) Initial or Prolonged Haemoglobin Decreased Health (Risperidone) PS ORAL TABLE, DAILY, Professional ORAL Imovane (Zopiclone) SS ORAL MG, DAILY, ORAL Sintrom (Acenocoumarol) SS ORAL MG, DAILY, ORAL 7 DAY Adalate Lp (Nifedipine) SS ORAL MG, DAILY, ORAL 7 DAY Praxilene (Naftidrofuryl Oxalate) SS ORAL MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 700 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/00ISR Number: 3451450-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000000415 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Risperdal (Tablet) (Risperidone) PS ORAL ORAL Depakote (Valproate Semisodium) C Date:02/03/00ISR Number: 3451454-9Report Type:Expedited (15-DaCompany Report #JRFUSA2000000409 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Consumer Risperdal (Solution) Initial or Prolonged (Risperidone) PS ORAL ORAL Date:02/04/00ISR Number: 3453057-9Report Type:Expedited (15-DaCompany Report #00P-163-0086516-00(0) Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Depakote (Depakote) Initial or Prolonged Intentional Overdose Professional (Divalproex Sodium) PS Miosis Other Tri-Buffered Sedation Bufferin SS ORAL PER ORAL Risperidone (Risperidone) SS Sertraline Hydrochloride (Sertraline Hydrochloride) SS Date:02/04/00ISR Number: 3457813-2Report Type:Expedited (15-DaCompany Report #JACGER2000000164 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal (1mg Health Tablet) Professional (Risperidone) PS ORAL 0.5 MG 1 IN 1 DAY(S) ORAL L-Dopa (Levodopa) C Pk-Merz (Amantadine Sulfate) C Date:02/07/00ISR Number: 3453421-8Report Type:Expedited (15-DaCompany Report #JRFUSA2000000365 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Risperdal Initial or Prolonged Cough (Risperidone) PS ORAL 1 MG, 2 IN 1 Required Dysphagia DAY(S), ORAL Intervention to Dyspnoea Pepcid (Famotidine) C Prevent Permanent Myocardial Infarction Remeron Impairment/Damage Nasopharyngeal Disorder (Mirtazapine) C Pharyngeal Neoplasm Ativan (Lorazepam) C Benign Lisinopril Renal Impairment (Lisinopril) C Salivary Hypersecretion Trazodone Swelling (Trazodone) C 22-Feb-2006 08:20 AM Page: 701 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspirin (Acetylsalicylic Acid) C Coumadin (Warfarin Sodium) C Prednisone (Prednisone) C Date:02/07/00ISR Number: 3453424-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000000485 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Risperdal Required Hyponatraemia Professional (Risperidone) PS ORAL 0.5 MG, 2 IN Intervention to Inappropriate 1 DAY(S), Prevent Permanent Antidiuretic Hormone ORAL;1 MG, 2 Impairment/Damage Secretion IN 1 DAY(S), Pneumonia Aspiration ORAL; 3 MG, 1 Zoloft (Sertraline Hydrochloride) C 25MG, 1 IN 1 TIME (S), ORAL Date:02/07/00ISR Number: 3454179-9Report Type:Expedited (15-DaCompany Report #JACGER2000000109 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Haldol (Tablet) Initial or Prolonged Suicidal Ideation Study (Haloperidol) PS ORAL 2 MG, 2 IN 1 Health DAY(S), ORAL Professional Risperdal (2 Mg Tablet) (Risperidone) SS ORAL 1 MG, 2 IN 1 DAY(S), ORAL Valverde (Valerian Extract) C Date:02/08/00ISR Number: 3454499-8Report Type:Expedited (15-DaCompany Report #JRFUSA2000000537 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paraplegia Consumer Risperdal (3 Mg Tablet) (Risperidone) PS ORAL 3 MG, 4 IN 1 DAY(S), ORAL Klonopin (Clonazepam) C Paxil (Paroxetine Hydrochloride) C Artane (Trihexyphenidyl Hydrocyloride) C Gllucophage (Metformin Hydrochloride) C Glyburide (Glibenclamide) C 22-Feb-2006 08:20 AM Page: 702 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/00ISR Number: 3457125-7Report Type:Expedited (15-DaCompany Report #A003388 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Health Zoloft Tablets PS ORAL ORAL Initial or Prolonged Drug Level Above Professional Extra Strength Bayer Required Therapeutic Pm SS ORAL ORAL Intervention to Heart Rate Increased Depakote SS ORAL ORAL Prevent Permanent Miosis Resperdal SS ORAL ORAL Impairment/Damage Sedation Date:02/14/00ISR Number: 3457178-6Report Type:Direct Company Report # Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Risperdal 1mg PS ORAL 0.5MG PO BID Lethargy Multi-Vitamin C Phoslo C Vasotec C Ec Asa C Nystatin C Date:02/15/00ISR Number: 3458216-7Report Type:Expedited (15-DaCompany Report #JRFUSA2000000579 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Dreams Consumer Risperdal (4 Mg Aphasia Tablet) Bradycardia (Risperidone) PS ORAL 4 MG, 1 IN 1 Liver Function Test DAY(S), ORAL Abnormal Cogentin Tongue Paralysis (Benzatropine Mesilate) C Unspecified C Date:02/15/00ISR Number: 3458217-9Report Type:Expedited (15-DaCompany Report #JRFUSA2000000471 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Health Risperdal (Tablet) Galactorrhoea Professional (Risperidone) PS ORAL 0.5, 3 MG, 1 Neutropenia IN 1 DAY(S), White Blood Cell Count ORAL Decreased Zoloft (Sertraline Hydrochloride) C Lactaid (Tilactase) C Date:02/15/00ISR Number: 3458447-6Report Type:Expedited (15-DaCompany Report #JRFUSA1999004157 Age:9 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Health Risperdal (1 Mg Epistaxis Professional Tablet) Purpura (Risperidone) PS ORAL 0.5 MG , 2 IN Pyrexia 1 DAY(S), Thrombocytopenia ORAL Depakote (Valproate Semisodium) C 22-Feb-2006 08:20 AM Page: 703 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eskalith Cr (Lithium Carbonate) C Date:02/15/00ISR Number: 3458448-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000000250 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnestic Disorder Literature Risperidone Initial or Prolonged Apraxia Health (Unspecified) Cerebral Ischaemia Professional (Risperidone) PS ORAL MG, DAILY, Chills ORAL Confusional State Paroxetine Coordination Abnormal (Paroxetine) SS DAILY Depressed Level Of Consciousness Depressed Mood Dyskinesia Electroencephalogram Abnormal Hallucination, Auditory Hyperreflexia Insomnia Lethargy Mental Disorder Movement Disorder Mydriasis Neuroleptic Malignant Syndrome Nuclear Magnetic Resonance Imaging Abnormal Overdose Restlessness Serotonin Syndrome Tachycardia Tremor Date:02/15/00ISR Number: 3458450-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000000449 Age:7 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Complications Of Maternal Consumer Risperdal (Tablet) Exposure To Therapeutic (Risperidone) PS 8 MG DAILY Drugs ORAL Convulsion Neonatal Cogentin Developmental Delay (Benzatropine Foetal Disorder Mesilate) SS ORAL Induced Labour Prozac (Fluoxetine Pregnancy Hydrochloride) SS ORAL ORAL Premature Baby Risperdal (Tablet) (Risperidone) SS UTERINE Congentin(Benzatropi ne Mesilate) SS UTERINE Prozac (Fluoxentine Hydrochloride) SS UTERINE 22-Feb-2006 08:20 AM Page: 704 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/15/00ISR Number: 3458452-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000000284 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal (Tablet) Thrombocytopenia Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Valproate Sodium (Valproate Sodium) SS ORAL MG DAILY ORAL Date:02/15/00ISR Number: 3458454-3Report Type:Expedited (15-DaCompany Report #JACGBR2000000063 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Renal Failure Acute Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Company Representative Date:02/15/00ISR Number: 3458457-9Report Type:Expedited (15-DaCompany Report #JACGBR2000000060 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Company Representative Date:02/15/00ISR Number: 3458491-9Report Type:Expedited (15-DaCompany Report #JRFBEL2000000279 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Risperidone Health (Unspecified) Professional (Risperidone) PS Flunitrazepam (Flunitrazepam) SS Date:02/15/00ISR Number: 3458516-0Report Type:Periodic Company Report #M094176 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lethargy Health Serzone Tabs Initial or Prolonged Professional (Nefazodone Hcl) PS ORAL ORAL Wellbutrin (Bupropion Hcl) SS ORAL ORAL Risperidone SS ORAL ORAL Date:02/15/00ISR Number: 3458577-9Report Type:Expedited (15-DaCompany Report #JRFBEL2000000269 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Risperdal (2 Mg Initial or Prolonged Health Tablet) Professional (Risperidone) PS ORAL MG, DAILY, 22-Feb-2006 08:20 AM Page: 705 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Marevan C Cisordinol C Lactulose C Furix C Date:02/15/00ISR Number: 3459660-4Report Type:Periodic Company Report #10051977 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Trazodone Hcl PS Overdose Professional Effexor (Venlafaxine Hcl) SS Risperdal (Risperidone) SS Date:02/17/00ISR Number: 3459064-4Report Type:Direct Company Report # Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Risperidone PS Muscle Rigidity Date:02/17/00ISR Number: 3459193-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Risperdal 1 Mg Bid PS ORAL PO BID Weight Increased Effexor C Depakote C Date:02/17/00ISR Number: 3459314-4Report Type:Expedited (15-DaCompany Report #JRFBEL1999002000 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Haloperidol Required Phosphokinase Increased Health (Haloperidol) PS ORAL MG, DAILY, Intervention to Hypokalaemia Professional ORAL Prevent Permanent Hyponatraemia Risperidone (Tablet) Impairment/Damage Inappropriate (Risperidone) SS ORAL MG, DAILY, Antidiuretic Hormone ORAL Secretion Risperidone (Tablet) Muscle Rigidity (Risperidone) SS ORAL MG, DAILY, Neuroleptic Malignant ORAL Syndrome Levomepromazine Polydipsia Maleate Polyuria (Levomepromazine Pyrexia Maleate) C Tremor Water Intoxication Date:02/17/00ISR Number: 3459412-5Report Type:Expedited (15-DaCompany Report #2000-02-0484 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Hospitalization - Mania Foreign Initial or Prolonged Health 22-Feb-2006 08:20 AM Page: 706 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Intron A (Interferon Alfa-2b Recombinant) Injectable Solution PS SUBCUTANEOUS 3 MU TIW SUBCUTANEOUS Ribavirin Capsules SS ORAL 1000 MG QD ORAL Sulpiride Tablets SS 100 MG QD Risperidone Tablets SS 4 MG QD Date:02/17/00ISR Number: 3459471-XReport Type:Expedited (15-DaCompany Report #JRFUSA2000000553 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ammonia Increased Health Risperdal(Risperdion Initial or Prolonged Coma Professional e) PS ORAL ORAL Required Condition Aggravated Depakote (Valproate Intervention to Hepatic Failure Semisodium) SS ORAL ORAL Prevent Permanent Nervous System Disorder Effexor (Venlafaxine Impairment/Damage Hydrochloride) SS ORAL ORAL Date:02/17/00ISR Number: 3459477-0Report Type:Expedited (15-DaCompany Report #JRFUSA2000000738 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:02/18/00ISR Number: 3459792-0Report Type:Expedited (15-DaCompany Report #JRFUSA2000000591 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL DAILY ORAL Imipramine (Imipramine) C Date:02/18/00ISR Number: 3459798-1Report Type:Expedited (15-DaCompany Report #JACGBR2000000089 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Foreign Risperdal Convulsion Health (Unspecified) Professional (Risperidone) PS ORAL MG DAILY ORAL Thioridazine (Thioridazine) C 22-Feb-2006 08:20 AM Page: 707 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/00ISR Number: 3459803-2Report Type:Expedited (15-DaCompany Report #JRFBEL2000000269 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bone Marrow Depression Foreign Risperdal (1 Mg Hospitalization - C-Reactive Protein Health Tablet) Initial or Prolonged Increased Professional (Risperidone) PS ORAL MG, 2 IN 1 Lung Infiltration DAY (S) ORAL Pneumonia Prednisolon Respiratory Failure (Prednisolone) SS Thrombocytopenia Marevan (Warfarin White Blood Cell Count Sodium) C Increased Cisordinol (Clopenthixol Hydrochloride) C Lactulose (Lactulose) C Furix (Furosemide) C Prednisone (Prednisone) C Date:02/18/00ISR Number: 3459808-1Report Type:Expedited (15-DaCompany Report #JRFUSA1999004307 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Activated Partial Health Risperdal (Tablet) Thromboplastin Time Professional (Risperidone) PS ORAL 8MG 1 IN 1 Prolonged DAY (S) ORAL Agitation Depakote (Valproate Blood Fibrinogen Semisodium) C Decreased Cogentin Cardiac Murmur (Benzatropine Coagulation Factor Xi Mesilate) C Level Decreased Coagulation Factor Xii Level Decreased Haematoma Haemorrhage Hyperkeratosis Intentional Self-Injury Le Cells Present Oedema Peripheral Prothrombin Level Decreased Skin Injury Thrombocytopenia Date:02/18/00ISR Number: 3459913-XReport Type:Periodic Company Report #8-99156-060A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Syncope Health Effexor PS ORAL 37.5 MG 3X Professional PER 1 DAY, ORAL Claritin SS ORAL ORAL Guaifenesin SS ORAL ORAL Risperdal SS ORAL 0.5MG DAILY INCREASED TO 1 MG DAILY, ORAL 22-Feb-2006 08:20 AM Page: 708 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Halotussin C Date:02/18/00ISR Number: 3460122-9Report Type:Periodic Company Report #8-99263-027A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Health Effexor PS ORAL ORAL Stupor Professional Risperdal SS ORAL ORAL Risperdal (Risperidone) C Date:02/18/00ISR Number: 3462350-5Report Type:Periodic Company Report #8-99153-133A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Effexor PS ORAL ORAL Initial or Prolonged Confusional State Professional Risperdal SS ORAL DOSE UNKNOWN, Other Delirium ORAL Hostility Risperdal (Risperidone) C Date:02/22/00ISR Number: 3460742-1Report Type:Expedited (15-DaCompany Report #JACGBR1999000496 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Foreign Risperdal Condition Aggravated Health (Unspecified) Glaucoma Professional (Risperidone) PS ORAL 1 MG 2 IN 1 Retinal Detachment Company DAY(S), ORAL Representative ; 2 MG 2 IN 1 DAY(S) ORAL Temazepam (Temazepam) C Thioridazine (Thioridazine) C Diazepam (Diazepam) C Date:02/22/00ISR Number: 3460745-7Report Type:Expedited (15-DaCompany Report #JRFUSA2000000344 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Polycythaemia Vera Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Atenolol (Atenolol) C Clonazepam (Clonazepam) C Cogentin (Benzatropine Mesilate) C 22-Feb-2006 08:20 AM Page: 709 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/00ISR Number: 3460780-9Report Type:Expedited (15-DaCompany Report #JACGER2000000196 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Brain Oedema Foreign Risperdal (4 Mg Convulsion Health Tablet) Fall Professional (Risperidone) PS ORAL 4 MG, 2 IN 1 Hyperkalaemia DAY (S), ORAL Hyponatraemia Atosil (Isopromethazine Hydrochloride) C Ritonavir (Ritonavir) C Beta-Blocker (Beta Blocking Agents) C Date:02/22/00ISR Number: 3460926-2Report Type:Expedited (15-DaCompany Report #JRFUSA1999004259 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:02/22/00ISR Number: 3463802-4Report Type:Periodic Company Report #JRFUSA1999003039 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Risperdal (3 Mg Initial or Prolonged Phosphokinase Increased Professional Tablet) Required Convulsion (Risperidone) PS ORAL 3 MG, 2 IN 1 Intervention to Hyponatraemia DAY(S), ORAL Prevent Permanent Pyrexia Clozaril (Clozapine) SS ORAL ORAL Impairment/Damage Date:02/22/00ISR Number: 3538646-5Report Type:Periodic Company Report #S00-USA-00008-01 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Urinary Incontinence Health Celexa PS Forest Laboratories Professional Inc ORAL 20 MG QD PO Risperdal SS ORAL 0.5 MG QD PO Date:02/23/00ISR Number: 3461384-4Report Type:Direct Company Report # Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Risperidone PS 0.25 MG QD Delirium Sedation Date:02/23/00ISR Number: 3461422-9Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Risperidone PS Syndrome 22-Feb-2006 08:20 AM Page: 710 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3462265-2Report Type:Periodic Company Report #9939186 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Zoloft Tablets PS Professional Risperdal SS Company Representative Date:02/23/00ISR Number: 3463649-9Report Type:Periodic Company Report #JRFUSA1999003170 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Risperdal (4 Mg Initial or Prolonged Condition Aggravated Tablet) Libido Decreased (Risperidone) PS ORAL 12 MG, DAILY, ORAL Tegretol (Carbamazepine) C Cogentin (Benzatropine Mesilate) C Date:02/23/00ISR Number: 3463652-9Report Type:Periodic Company Report #JRFUSA1999003173 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Increased Health Risperdal (Tablet) Initial or Prolonged Electrocardiogram Professional (Risperidone) PS ORAL 60 MG, 1 IN Abnormal 1TME(S), ORAL Tachycardia Motrin (Ibuprofen) SS ORAL 2400 MG, 1 IN 1 TIME(S), ORAL Cocaine (Cocaine) SS ORAL ORAL Date:02/23/00ISR Number: 3463656-6Report Type:Periodic Company Report #JRFUSA1999003190 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Risperdal (Tablet) Initial or Prolonged (Risperidone) PS ORAL ORAL Date:02/23/00ISR Number: 3463658-XReport Type:Periodic Company Report #JRFUSA1999003278 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Risperdal Initial or Prolonged Phosphokinase Increased Professional (Unspecified) Required Pneumonia (Risperidone) PS ORAL ORAL Intervention to Unspecified Prevent Permanent (Unspecified) SS Impairment/Damage 22-Feb-2006 08:20 AM Page: 711 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3463662-1Report Type:Periodic Company Report #JRFUSA1999003280 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (4 Mg Initial or Prolonged Nausea Tablet) (Risperidone) PS ORAL ORAL Risperdal(4 Mg Tablet) (Risperidone) SS 4 MG, 1 IN 1 DAY(S), ORAL Date:02/23/00ISR Number: 3463666-9Report Type:Periodic Company Report #JRFUSA1999003382 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal (3 Mg Initial or Prolonged Condition Aggravated Tablet) (Risperidone) PS ORAL 3 MG, 1 IN 1 DAY(S), ORAL Date:02/23/00ISR Number: 3463670-0Report Type:Periodic Company Report #JRFUSA1999003385 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Risperdal (Tablet) Initial or Prolonged (Risperidone) PS ORAL 5 MG, 2 IN 1 DAY(S), ORAL Folic Acid (Folic Cid) C Date:02/23/00ISR Number: 3463674-8Report Type:Periodic Company Report #JRFUSA1999003386 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (Tablet) Initial or Prolonged (Risperidone) PS ORAL ORAL Seroquel (Seroquel) C Date:02/23/00ISR Number: 3463677-3Report Type:Periodic Company Report #JRFUSA1999003389 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoglycaemia Health Risperdal (Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL 0.25 MG, 2 IN Required 1 DAY(S), Intervention to ORAL Prevent Permanent Impairment/Damage Date:02/23/00ISR Number: 3463702-XReport Type:Periodic Company Report #JRFUSA1999003408 Age: Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:20 AM Page: 712 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Risperdal Phosphokinase Increased Professional (Unspecified) Pneumonia (Risperidone) PS ORAL ORAL Unspecified (Unspecified) C Date:02/23/00ISR Number: 3463705-5Report Type:Periodic Company Report #JRFUSA1999003415 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Health Risperdal Initial or Prolonged Ear Disorder Professional (Unspecified) Leukocytosis (Risperidone) PS ORAL ORAL Lymphadenopathy Tegretol Pyrexia (Carbamazepine) SS ORAL 100 MG, 2 IN Rhinitis 1 DAY(S), ORAL/200 MG, 2 IN 1 DAY(S), ORAL Date:02/23/00ISR Number: 3463711-0Report Type:Periodic Company Report #JRFUSA1999003418 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL ORAL Zyprexa (Olanzapine) SS ORAL ORAL Date:02/23/00ISR Number: 3463713-4Report Type:Periodic Company Report #JRFUSA1999003420 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Health Risperdal (Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL ORAL Required Intervention to Prevent Permanent Impairment/Damage Date:02/23/00ISR Number: 3463717-1Report Type:Periodic Company Report #JRFUSA1999003615 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Risperdal (Tablet) Initial or Prolonged (Risperidone) PS ORAL ORAL Trazodone (Trazodone) C Depakote (Valproate Semisodium) C Zoloft (Sertraline Hydrochloride) C 22-Feb-2006 08:20 AM Page: 713 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3463727-4Report Type:Periodic Company Report #JRFUSA1999003651 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal (1 Mg Initial or Prolonged Syndrome Professional Tablet) Required (Risperidone) PS ORAL 1 MG, 2 IN 1 Intervention to DAY(S), ORAL Prevent Permanent Impairment/Damage Date:02/23/00ISR Number: 3463734-1Report Type:Periodic Company Report #JRFUSA1999003652 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal (0.5 Mg Initial or Prolonged Syndrome Professional Tablet) Required (Risperidone) PS ORAL 0.5 MG, 2 IN Intervention to 1 DAY(S), Prevent Permanent ORAL Impairment/Damage Paxil (Paroxetine Hydrochloride) C Date:02/23/00ISR Number: 3463739-0Report Type:Periodic Company Report #JRFUSA1999003653 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal (1 Mg Initial or Prolonged Syndrome Professional Tablet) Required (Risperidone) PS ORAL 1 MG, 2 IN 1 Intervention to DAY(S), ORAL Prevent Permanent Impairment/Damage Date:02/23/00ISR Number: 3463743-2Report Type:Periodic Company Report #JRFUSA1999003679 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Risperdal (Tablet) Initial or Prolonged (Risperidone) PS ORAL ORAL Date:02/23/00ISR Number: 3463747-XReport Type:Periodic Company Report #JRFUSA1999003776 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Risperdal (3 Mg Initial or Prolonged Hallucination Tablet) (Risperidone) PS ORAL 3 MG, 2 IN 1 DAY(S), ORAL Trazodone (Trazodone) SS ORAL 150 MG, 1 IN 1 DAY(S), ORAL Depakote (Valproate Semisodium) C Zoloft (Sertraline Hydrochloride) C Lipitor 22-Feb-2006 08:20 AM Page: 714 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Atorvastatin) C Date:02/23/00ISR Number: 3463755-9Report Type:Periodic Company Report #JAUSA27714 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oculogyration Health Risperdal Initial or Prolonged Professional (Risperidone) PS ORAL ORAL Date:02/23/00ISR Number: 3463757-2Report Type:Periodic Company Report #JRFUSA1999002411 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Risperdal (Tablet) Initial or Prolonged (Risperidone) PS ORAL ORAL Date:02/23/00ISR Number: 3463759-6Report Type:Periodic Company Report #JRFUSA1999002412 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Risperdal (Tablet) Initial or Prolonged (Risperidone) PS ORAL ORAL Date:02/23/00ISR Number: 3463761-4Report Type:Periodic Company Report #JRFUSA1999002423 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (Tablet) Initial or Prolonged Weight Decreased (Risperidone) PS ORAL 6 MG, DAILY, ORAL Date:02/23/00ISR Number: 3463764-XReport Type:Periodic Company Report #JRFUSA1999002436 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (Tablet) Initial or Prolonged Diabetes Mellitus Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL (SEE IMAGE) Date:02/23/00ISR Number: 3463767-5Report Type:Periodic Company Report #JRFUSA1999002438 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (2 Mg Initial or Prolonged Professional Tablet) (Risperidone) PS ORAL 2 MG, PRN, ORAL Haldol (Injection ) (Haloperidol) SS INTRAMUSCULAR PRN, IM 22-Feb-2006 08:20 AM Page: 715 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3463769-9Report Type:Periodic Company Report #JRFUSA1999002446 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Health Risperdal (1 Mg Initial or Prolonged Professional Tablet) (Risperidone) PS ORAL 1 MG, DAILY, ORAL (SEE IMAGE) Elavil (Amitriptyline Hydrochloride) C Date:02/23/00ISR Number: 3463772-9Report Type:Periodic Company Report #JRFUSA1999002494 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Health Risperdal (1 Mg Blood Ethanol Increased Professional Tablet) Cardio-Respiratory Arrest (Risperidone) PS ORAL 1 MG, 2 IN 1 Circulatory Collapse DAY(S), ORAL Sudden Death Zyprexa (Olanzapine) SS ORAL 10 MG, DAILY, ORAL Depakote (Valproate Semisodium) C Klonopin (Clonazepam) C Zocor (Simvastatin) C Altace (Ramipril) C Aspirin (Acetylsalicylic Acid) C Colace (Docusate Sodium) C Date:02/23/00ISR Number: 3463774-2Report Type:Periodic Company Report #JRFUSA1999002500 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (2 Mg Initial or Prolonged Visual Disturbance Professional Tablet) (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY(S), ORAL Depakote (Valproate Semisodium) SS ORAL 250 MG, 3 IN 1 DAY(S), ORAL (SEE IMAGE) Prozac (Fluoxetine Hydrochloride) SS ORAL 20 MG, 2 IN 1 DAY(S), ORAL Ativan (Lorazepam) SS ORAL ORAL Date:02/23/00ISR Number: 3463775-4Report Type:Periodic Company Report #JRFUSA1999002656 Age:25 YR Gender:Female I/FU:I Outcome PT Hospitalization - Neuroleptic Malignant Initial or Prolonged Syndrome 22-Feb-2006 08:20 AM Page: 716 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, 1 IN 1 DAY(S), ORAL (SEE IMAGE) Haldol Decanoate (Injection) (Haloperidol Decanoate) SS INTRAMUSCULAR 1 IN 1 MONTH(S), IM Date:02/23/00ISR Number: 3463776-6Report Type:Periodic Company Report #JRFUSA1999002661 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (Tablet) Initial or Prolonged Convulsion (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL (SEE IMAGE) Dilantin (Phenytoin Sodium) C Phenobarbitol (Phenobarbital) C Ativan (Lorazepam) C Date:02/23/00ISR Number: 3463778-XReport Type:Periodic Company Report #JRFUSA1999002697 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Risperdal (3 Mg Initial or Prolonged Professional Tablet) Required (Risperidone) PS ORAL 9 MG, DAILY, Intervention to ORAL Prevent Permanent Zyprexa (Olanzapine) C Impairment/Damage Thiothixene (Tiotixene) C Cogentin (Benzatropine Mesilate) C Date:02/23/00ISR Number: 3463780-8Report Type:Periodic Company Report #JRFUSA1999002709 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Risperdal (Tablet) Initial or Prolonged Sedation Professional (Risperidone) PS ORAL 2 MG, 3 IN 1 Required DAY(S), ORAL Intervention to (SEE IMAGE) Prevent Permanent Depakote (Valproate Impairment/Damage Semisodium) SS ORAL ORAL Synthroid (Levothyroxine Sodium) C Nifedipine (Nifedipine) C 22-Feb-2006 08:20 AM Page: 717 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspirin (Acetylsalicylic Acid) C Date:02/23/00ISR Number: 3463784-5Report Type:Periodic Company Report #JRFUSA1999002715 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Initial or Prolonged Syndrome Professional (Unspecified) Tardive Dyskinesia (Risperidone) PS ORAL ORAL Navane (Tiotixene) C Date:02/23/00ISR Number: 3463787-0Report Type:Periodic Company Report #JRFUSA1999002739 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (Tablet) Initial or Prolonged Galactorrhoea Professional (Risperidone) PS ORAL 2 MG, DAILY, Hyperprolactinaemia ORAL (SEE IMAGE) Date:02/23/00ISR Number: 3463789-4Report Type:Periodic Company Report #JRFUSA1999002833 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (1 Mg Initial or Prolonged Professional Tablet) (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY(S), ORAL Haldol (Tablet) (Haloperidol) SS ORAL 10 MG, DAILY, ORAL Date:02/23/00ISR Number: 3463791-2Report Type:Periodic Company Report #JRFUSA1999002870 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phlebitis Health Risperdal (Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL 0.5 MG, 1 IN Required 1 DAY(S), Intervention to ORAL Prevent Permanent Depakote (Valproate Impairment/Damage Semisodium) C Hypoglycemic (Hypoglycemics) C Benadryl (Diphenhydramine Hydrochloride) C Date:02/23/00ISR Number: 3463794-8Report Type:Periodic Company Report #JRFUSA1999002963 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Consumer Risperdal (Tablet) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 718 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3463797-3Report Type:Periodic Company Report #JRFUSA1999002986 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Therapeutic Response Consumer Risperdal (2 Mg Initial or Prolonged Decreased Tablet) (Risperidone) PS ORAL 2 MG, 1 IN 1 DAY(S), ORAL Prescription Medication, Nos C Date:02/23/00ISR Number: 3463799-7Report Type:Periodic Company Report #JRFUSA1999002988 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal (2 Mg Initial or Prolonged Tablet) (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY(S), ORAL Depakote (Valproate Semisodium) C Unspecified (Unspecified) C Date:02/23/00ISR Number: 3466371-8Report Type:Periodic Company Report #9919124 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Zoloft Tablets PS Thrombocytopenia Professional Risperdal SS Company Representative Date:02/23/00ISR Number: 3466375-5Report Type:Periodic Company Report #9919127 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Zoloft Tablets PS 150.00 MG Menstrual Disorder Professional TOTAL DAILY Company Risperdal SS 1.00 MG TOTAL Representative DAILY Prednisone SS Date:02/23/00ISR Number: 3466903-XReport Type:Periodic Company Report #JAUSA36133 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Risperdal Initial or Prolonged Condition Aggravated Professional (Risperidone) PS ORAL ORAL Suicide Attempt Zyprexa (Olanzapine) SS ORAL ORAL Lithium (Lithium) SS ORAL ORAL Prozac (Fluoxetine) C 22-Feb-2006 08:20 AM Page: 719 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3466907-7Report Type:Periodic Company Report #JAUSA36166 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Professional (Risperidone) PS ORAL ORAL Remeron (Mirtazapine) C Date:02/23/00ISR Number: 3466910-7Report Type:Periodic Company Report #JAUSA36172 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Consumer Risperdal (Tablet 4 Initial or Prolonged Diabetes Mellitus Mg) (Risperidone) PS ORAL 4 MG, 1 IN 1 Increased Appetite DAY(S), ORAL Tachycardia Lithium (Tablet) Thirst (Lithium) C Depakote (Tablet) (Valproate Sodium) C Klonopin (Tablet) (Clonazepam) C Date:02/23/00ISR Number: 3466912-0Report Type:Periodic Company Report #JAUSA36209 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Risperdal (Tablet 2 Initial or Prolonged Condition Aggravated Professional Mg) (Risperidone) PS (1 MG 2 DAILY Suicide Attempt 28-JAN-99):(2 MG 2 DAILY 04-FEB-99) Date:02/23/00ISR Number: 3466916-8Report Type:Periodic Company Report #JAUSA36236 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Risperdal Initial or Prolonged Phosphokinase Increased Professional (Risperidone) PS (1 MG 2 DAILY Condition Aggravated 30-JUN-97):(2 MG DAILY 16-JAN-99) Lithium (Lithium) SS (16-JAN-99):D OSE INCREASED (NOS)600 MG 2 DAILY Date:02/23/00ISR Number: 3466920-XReport Type:Periodic Company Report #JAUSA36406 Age:25 YR Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Albumin Globulin Ratio Abnormal Condition Aggravated Depression Drug Abuser Galactorrhoea 22-Feb-2006 08:20 AM Page: 720 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paranoia Suicide Attempt Vomiting Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal (Tablet) ( Risperidone) PS ORAL 4 MG, 1 IN 1 DAY(S), ORAL2)5MG,DAI LY, ORAL3)4 MG, 3 IN 1 Haldol (Tablet) (Haloperidol) C Haldol Decanoas(50 Mg/Ml Injection)(Haloperid ol Decanoate) C Date:02/23/00ISR Number: 3466922-3Report Type:Periodic Company Report #JAUSA36444 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Risperdal (Tablet 3 Initial or Prolonged Depression Mg) (Risperidone) PS (2 MG 1 DAILY Suicide Attempt 15-AUG-94):(1 Thinking Abnormal MG 1 DAILY 16-FEB-98) Depakote (Tablet 250 Mg)(Valproate Sodium) C Klonopin (Tablet .5 Mg)(Clonazepam) C Date:02/23/00ISR Number: 3466935-1Report Type:Periodic Company Report #JAUSA36453 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Risperdal (Tablet 2 Initial or Prolonged Hepatitis Cholestatic Professional Mg) (Risperidone) PS (2MG 1 DAILY Required Nausea 15-DEC-98): Intervention to Pruritus Insulin Prevent Permanent (Suspension)(Insulin Impairment/Damage ) C Feosol (Tablet)(Ferrous Sulfate) C Ativan (Tablet)(Lorazepam) C Date:02/23/00ISR Number: 3466936-3Report Type:Periodic Company Report #JAUSA36466 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal (Tablet 1 Initial or Prolonged Hypertonia Mg) (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Requip (Tablet)(Ropinirole) C 22-Feb-2006 08:20 AM Page: 721 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3466938-7Report Type:Periodic Company Report #JAUSA36487 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Risperdal Initial or Prolonged Insomnia (Tablet)(Risperidone Suicide Attempt ) PS ORAL 2 MG, 1 IN 1 DAY(S), ORAL/3 MG, 1 IN 1 DAY(S), ORAL Relafen (Tablet)(Nabumetone) C Robaxin (Tablet)(Methocarbam ol) C Ambien (Tablet)(Zolpidem) C Klonopin (Tablet 1 Mg)(Clonazepam) C Effexor (Tablet)(Venlafexine ) C Prozac (Capsules)(Fluoxetin e) C Remeron (Mirtazapine) C Singulair (Montelukast Sodium) C Celebrex (Celecoxib) C Date:02/23/00ISR Number: 3466990-9Report Type:Periodic Company Report #JAUSA36668 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Health Risperdal (Tablet 3 Initial or Prolonged Suicide Attempt Professional Mg)(Risperidone) PS (240 MG SINGLE 15-MAR-99):TO OK EIGHTY 3 MG TABLETS Date:02/23/00ISR Number: 3466993-4Report Type:Periodic Company Report #JAUSA36684 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Hypothermia Professional (Risperidone) PS ORAL 0.5 MG, 2 IN Required 1 DAY(S), Intervention to ORAL Prevent Permanent Impairment/Damage 22-Feb-2006 08:20 AM Page: 722 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3467000-XReport Type:Periodic Company Report #JAUSA36742 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Risperdal (3mg Initial or Prolonged Apathy Tablet)(Risperidone) PS Gait Disturbance Lithium (Lithium) C Nervousness Cogentin (Tablet 2 Sedation Mg)(Benzatropine Speech Disorder Mesilate) C Ramipril (Capsules)(Ramipril) C Antihypertensive Agents (Tablet)(Antihyperte nsive Agents) C Wellbutrin (Amfebutamone Hydrochloride) C Date:02/23/00ISR Number: 3467001-1Report Type:Periodic Company Report #JAUSA36751 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal Initial or Prolonged Eyelid Ptosis (Tablet)(Risperidone Oedema ) PS (6 MG DAILY Weight Increased 15-MAR-96):TI TRATED UP TO 10 MG DAILY Risperdal (Solution 1 Mg/Ml)Risperidone) SS ORAL 10 MG, DAILY, ORAL Date:02/23/00ISR Number: 3467007-2Report Type:Periodic Company Report #JAUSA36761 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Risperdal (4 Mg Initial or Prolonged Chest Pain Professional Tablet) Condition Aggravated (Risperidone) PS ORAL 4 MG, 2 IN 1 Depression DAY(S), ORAL Eye Disorder Artane (Tablet 2 Face Oedema Mg)(Trihexyphenidyl) C Pain Seroquel(Seroquel) C Photosensitivity Reaction Paxil (Paroxetine Visual Disturbance Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:02/23/00ISR Number: 3467009-6Report Type:Periodic Company Report #JAUSA36786 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal Initial or Prolonged Erectile Dysfunction (Tablet)(Tisperidone Nervousness ) PS (1 MG 2 DAILY 15-MAR-98):(3 22-Feb-2006 08:20 AM Page: 723 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report MG DAILY 08-MAR-99):1 MG INAM, 2 MG Motrin (Tablet)(Ibuprofen) C Date:02/23/00ISR Number: 3467012-6Report Type:Periodic Company Report #JAUSA36789 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Risperdal (Tablet) Initial or Prolonged Aggression (Risperidone) PS ORAL 1 MG, 1 IN 1 Agitation DAY(S), ORAL Anorgasmia Seroquel Libido Decreased (Quetiapine) C Thirst Effexor Weight Increased (Tablet)(Venlafexine ) C Klonopin (Tablet .5 Mg)(Clonazepam) C Artane (Tablet 2 Mg)(Trihexyphenidyl) C Aldactone (Tablet 50 Mg)(Spironolactone) C Levothroid (Tablet .1 Mg)(Levothyroxine) C Date:02/23/00ISR Number: 3467017-5Report Type:Periodic Company Report #JAUSA36795 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Risperdal Initial or Prolonged Arthralgia (Tablet)(Risperidone Headache ) PS (3 MG 4 DAILY Pneumonia 15-FEB-94): Klonopin (Tablet 2 Mg)(Clonazepam) C Artane (Tablet 2mg)(Trihexyphenidyl ) C Gluophage (Tablet 500 Mg)(Metformin) C Paxil (Tablet)(Paroxetine) C Glyburide (Tablet 5 Mg)(Glibenclamide) C Date:02/23/00ISR Number: 3467021-7Report Type:Periodic Company Report #JAUSA36796 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Health Risperdal Initial or Prolonged Urticaria Professional (Tablet)(Risperidone ) PS ORAL ORAL Glipizide (Glipizide) C Tegretol (Carbamazepine) C 22-Feb-2006 08:20 AM Page: 724 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lipitor (Atorvastatin) C Lodine (Etodolac) C Aspirin (Acetylsalicylic Acid) C Ibuprofen (Ibuprofen) C Date:02/23/00ISR Number: 3467025-4Report Type:Periodic Company Report #JAUSA36988 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Risperdal Initial or Prolonged Laboratory Test Abnormal Professional (Tablet)(Risperidone Required ) PS ORAL Intervention to Prevent Permanent Impairment/Damage Date:02/23/00ISR Number: 3467028-XReport Type:Periodic Company Report #JAUSA36994 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Consumer Risperdal (Tablet 1 Initial or Prolonged Cerebrovascular Disorder Health Mg)(Risperidone) PS ORAL 1 MG, 1 IN 1 Dermatitis Professional DAY(S), ORAL Hypokinesia Megestrol Sedation (Megestrol) C Aricept (Tablet 10 Mg)(Donepezil) C Date:02/23/00ISR Number: 3467032-1Report Type:Periodic Company Report #JAUSA36996 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (Tablet 3 Initial or Prolonged Sedation Mg)(Risperidone) PS SEE IMAGE Date:02/23/00ISR Number: 3467033-3Report Type:Periodic Company Report #JAUSA37003 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (1 Mg Initial or Prolonged Emotional Disorder Professional Tablet)(Risperidone) PS ORAL 1 MG, 2 IN 1 Insomnia DAY(S), ORAL Mania Date:02/23/00ISR Number: 3467036-9Report Type:Periodic Company Report #JAUSA37034 Age:70 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:20 AM Page: 725 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Risperdal (Tablet 1 Professional Mg) (Risperidone) PS SEE IMAGE Thyroxine (Tablet)(Levothyroxi ne) C Rezulin (Tablet)(Troglitazon e) C Plavix (Tablet)(Valproate Sodium) C Trazodone (Tablet)(Trazodone) C Date:02/23/00ISR Number: 3467043-6Report Type:Periodic Company Report #JAUSA37035 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (Tablet 2 Initial or Prolonged Mg)(Risperidone) PS SEE IMAGE Zoloft (Sertraline) C Clozaril (-Clozapine) C Lescol (Fluvastatin) C Prilosec (Omeprazole) C Date:02/23/00ISR Number: 3467049-7Report Type:Periodic Company Report #JAUSA37116 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Health Risperdal (2 Mg Initial or Prolonged Abnormal Professional Tablet)(Risperidone) PS ORAL 2 MG, 1 IN 1 Electrocardiogram Qt DAY(S), ORAL Prolonged Artane Mitral Valve Incompetence (Trihexyphenidyl) C Syncope Prozac (Fluoxetine Hydrochloride) C Date:02/23/00ISR Number: 3467052-7Report Type:Periodic Company Report #JAUSA37119 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (Tablet 3 Initial or Prolonged Mg)(Risperidone) PS SEE IMAGE Depakote (Valproate Sodium) C Date:02/23/00ISR Number: 3467055-2Report Type:Periodic Company Report #JAUSA37223 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Diabetes Mellitus Professional (Tablet)(Risperidone 22-Feb-2006 08:20 AM Page: 726 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ) PS ORAL ORAL Date:02/23/00ISR Number: 3467059-XReport Type:Periodic Company Report #JAUSA37224 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Risperdal Initial or Prolonged (Tablet)(Risperidone ) PS SEE IMAGE Date:02/23/00ISR Number: 3467063-1Report Type:Periodic Company Report #JAUSA37247 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Disorder Consumer Risperdal (Tablet) Initial or Prolonged (Risperidone) PS ORAL ORAL Lanoxin (Digoxin) C Klonopin (Clonazepam) C Date:02/23/00ISR Number: 3467071-0Report Type:Periodic Company Report #JAUSA37280 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Risperdal (Tablet 2 Initial or Prolonged Sedation Mg)(Risperidone) PS ORAL 2 MG, 3 IN 1 DAY(S), ORAL Depakote (Valproate Sodium) C Date:02/23/00ISR Number: 3467073-4Report Type:Periodic Company Report #JAUSA37287 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urea Increased Health Risperdal (1 Mg Initial or Prolonged Condition Aggravated Professional Tablet)(Risperidone) PS ORAL SEE IMAGE , Dehydration ORAL Pneumonia Diphenoxylate (Diphenoxylate) C Dilantin (Phenytoin) C Prednisone (Prednisone) C Flomax (Tamsulosin) C Atenolol (Atenolol) C Detrol (Tolterodine) C Prinivil (Lisinopril) C Hctz (Hctz/Reserpine) C Tenopt (Timolol) C Lasix (Furosemide) C Furosemide (Furosemide) C 22-Feb-2006 08:20 AM Page: 727 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3467077-1Report Type:Periodic Company Report #JRFUSA1999000022 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Risperdal (1 Mg Condition Aggravated Professional Tablet)(Risperidone) PS ORAL MG, DAILY, Insomnia ORAL Suicide Attempt Congentin Vomiting (Benzatropine Mesilate) SS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Date:02/23/00ISR Number: 3467081-3Report Type:Periodic Company Report #JRFUSA1999000041 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bursitis Consumer Risperdal Initial or Prolonged Condition Aggravated Health (Unspecified) Dermatitis Professional (Risperidone) PS ORAL SEE IMAGE , Scoliosis ORAL Depakote (Valproate Semisodium) SS ORAL ORAL Celebrex (Celecoxib) C Date:02/23/00ISR Number: 3467084-9Report Type:Periodic Company Report #JRFUSA1999000060 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Risperdal Initial or Prolonged Professional (Unspecified)(Risper idone) PS ORAL ORAL Ritalin (Methylphenidate Hydrochloride) C Date:02/23/00ISR Number: 3467090-4Report Type:Periodic Company Report #JRFUSA1999000069 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Risperdal (1 Mg Initial or Prolonged Drug Withdrawal Syndrome Professional Tablet)(Risperidone) PS ORAL 1.5 MG, 1 IN 1 DAY(S), ORAL Insulin (Insulin) C Date:02/23/00ISR Number: 3467094-1Report Type:Periodic Company Report #JRFUSA1999000190 Age:28 YR Gender:Male I/FU:I Outcome PT Hospitalization - Aggression Initial or Prolonged Alopecia Anxiety Condition Aggravated Coordination Abnormal Dermatitis Dystonia Gastrointestinal Disorder 22-Feb-2006 08:20 AM Page: 728 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Headache Hepatocellular Damage Herpes Zoster Report Source Product Role Manufacturer Route Dose Duration Hypersensitivity Consumer Risperdal Hypertension (Tablet)(Risperidone Injury ) PS ORAL SEE IMAGE , Insomnia ORAL Muscular Weakness Haldol Sedation (Tablet)(Halopeidol) SS ORAL ORAL Tachycardia Zinc (Zinc) C Thinking Abnormal Date:02/23/00ISR Number: 3467097-7Report Type:Periodic Company Report #JRFUSA1999000209 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaphylactoid Reaction Health Risperdal Initial or Prolonged Professional (Unspecified) (Risperidone) PS ORAL 3 MG, DAILY, ORAL 9 MON Date:02/23/00ISR Number: 3467100-4Report Type:Periodic Company Report #JRFUSA1999000218 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal (1 Mg Initial or Prolonged Syndrome Professional Tablet)(Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Congentin (Benzatropine Mesilate) C Date:02/23/00ISR Number: 3467104-1Report Type:Periodic Company Report #JRFUSA1999000254 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Health Risperdal Initial or Prolonged Neurosis Professional (Tablet)(Risperidone Required Suicide Attempt ) PS ORAL 2 MG, 1 IN 1 Intervention to DAY(S), ORAL Prevent Permanent Tylenol Extra Impairment/Damage Strength (Paracetamol) SS ORAL 15 MG, 30 IN 1 TIME(S), ORAL Celexa (Citalopram Hydrobromide) SS ORAL SEE IMAGE, ORAL Lithium Carbonate (Lithium Carbonate) C Prozac (Fluoxetine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 729 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3467114-4Report Type:Periodic Company Report #JRFUSA1999000259 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Health Risperdal (Tablet) Initial or Prolonged Psychotic Disorder Professional (Risperidone) PS ORAL ORAL Date:02/23/00ISR Number: 3467118-1Report Type:Periodic Company Report #JRFUSA1999000271 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Risperdal (Tablet) Initial or Prolonged Attention Professional (Risperidone) PS ORAL ORAL Deficit/Hyperactivity Venlafaxine Disorder (Venlafaxine) SS ORAL ORAL Confusional State Delirium Date:02/23/00ISR Number: 3467121-1Report Type:Periodic Company Report #JRFUSA1999000459 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (4 Mg Initial or Prolonged Hyperprolactinaemia Professional Tablet) (Risperidone) PS ORAL 4 MG, 1 IN 1 DAY(S), ORAL Haldol (Tablet) (Haloperidol) C Cogentin (Benzatropine Mesilate) C Claritin (Loratadine) C Propranolol) (Propranolol) C Ambien (Zolpidem Tartrate) C Acetaminophen (Paracetamol) C Levoxyl (Levothyroxine Sodium) C Minocycline (Minocycline) C Date:02/23/00ISR Number: 3467125-9Report Type:Periodic Company Report #JRFUSA1999000481 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gynaecomastia Consumer Risperdal (1 Mg Initial or Prolonged Mania Tablet) Weight Increased (Risperidone) PS ORAL 0.25 MG, 0.5 MG 1 IN 1 DAY(S), ORAL Periactin (Cyproheptadine Hydrochloride) C Depakote (Valproate Semisodium) C 22-Feb-2006 08:20 AM Page: 730 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Wellbutrin (Amfebutamone Hydrochloride) C Date:02/23/00ISR Number: 3467128-4Report Type:Periodic Company Report #JRFUSA1999000490 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 3 MG, 1 IN 1 DAY(S), ORAL Zyprexa (Olanzapine) SS ORAL 10 MG, 2 IN 1 DAY(S), ORAL Paxil (Paroxetine Hydrochloride) C Date:02/23/00ISR Number: 3467131-4Report Type:Periodic Company Report #JRFUSA1999000568 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Risperdal (2 Mg Initial or Prolonged Ketoacidosis Professional Tablet) (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY (S), ORAL Prozac (Fluoxetine Hydrochloride) C Trazodone (Trazodone) C Date:02/23/00ISR Number: 3467135-1Report Type:Periodic Company Report #JRFUSA1999000573 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Health Risperdal (3 Mg Initial or Prolonged Hepatitis Professional Tablet) Weight Decreased (Risperidone) PS ORAL 3 MG, 2 IN 1 DAY(S), ORAL Lithium (Lithium) C Date:02/23/00ISR Number: 3467136-3Report Type:Periodic Company Report #JRFUSA1999000644 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Health Risperdal (Tablet) Initial or Prolonged Hepatic Enzyme Increased Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 Required DAY(S), ORAL Intervention to Prevent Permanent Impairment/Damage Date:02/23/00ISR Number: 3467143-0Report Type:Periodic Company Report #JRFUSA1999000725 Age:9 YR Gender:Female I/FU:I Outcome PT Hospitalization - Aggression Initial or Prolonged Drug Withdrawal Syndrome 22-Feb-2006 08:20 AM Page: 731 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyskinesia Gait Disturbance Hypertonia Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 9 MG, DAILY, ORAL Prozac (Fluoxetine Hydrochloride) C Depakote (Valproate Semisodium) C Date:02/23/00ISR Number: 3467155-7Report Type:Periodic Company Report #JRFUSA1999000865 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Risperdal (1 Mg Initial or Prolonged Oedema Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAY(S), ORAL Artane (Triheyphenidyl Hydrochloride) C Lescol (Fluvastatin Sodium) C Timoptic (Timolol Maleate) C Klonopin (Clonazepam) C Thorazine (Chlorpromazine Hydrochloride) C Date:02/23/00ISR Number: 3467163-6Report Type:Periodic Company Report #JRFUSA1999000880 Age:23 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Literature Risperdal (Tablet) Health (Risperidone) PS ORAL ORAL Professional Benzotropine (Benzatropine Mesilate) SS ORAL ORAL Date:02/23/00ISR Number: 3467167-3Report Type:Periodic Company Report #JRFUSA1999000881 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Literature Risperdal (Tablet) Health (Risperidone) PS ORAL ORAL Professional Acetaminophen (Paracetamol) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 732 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3467171-5Report Type:Periodic Company Report #JRFUSA1999000882 Age:44 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Literature Risperdal (Tablet) Health (Risperidone) PS ORAL ORAL Professional Propanolol (Propranolol) SS ORAL ORAL Clonazepam (Clonazepam) SS ORAL ORAL Date:02/23/00ISR Number: 3467176-4Report Type:Periodic Company Report #JRFUSA1999000883 Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Literature Risperdal (Tablet) Health (Risperidone) PS ORAL ORAL Professional Aspirin (Acetylsalicylic Acid) SS ORAL ORAL Date:02/23/00ISR Number: 3467180-6Report Type:Periodic Company Report #JRFUSA1999000884 Age:28 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Literature Risperdal (Tablet) Health (Risperidone) PS ORAL ORAL Professional Verapamil (Verapamil) SS ORAL ORAL Cocaine (Cocaine) SS ORAL ORAL Date:02/23/00ISR Number: 3467186-7Report Type:Periodic Company Report #JRFUSA1999000987 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal (Tablet) Initial or Prolonged Cough (Risperidone) PS ORAL 2 MG, 6MG, Muscle Contractions DAILY, ORAL Involuntary Ritalin Tremor (Methylphenidate Hydrochloride) C Date:02/23/00ISR Number: 3467196-XReport Type:Periodic Company Report #JRFUSA1999001101 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Consumer Risperdal (1 Mg Initial or Prolonged Tablet) (Risperidone) PS ORAL 2 MG, 1MG, 1 IN 1 DAY(S), ORAL Doxepin (Doxepin) SS ORAL 400 MG, 1 IN 1 DAY(S), ORAL Remeron (Mirtazapine) C 22-Feb-2006 08:20 AM Page: 733 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3467203-4Report Type:Periodic Company Report #JRFUSA1999001119 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, 1 IN 1 DAY(S), ORAL Depakote (Valproate Semisodium) SS ORAL ORAL Date:02/23/00ISR Number: 3467207-1Report Type:Periodic Company Report #JRFUSA1999001143 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastritis Consumer Risperdal (Tablet) Initial or Prolonged (Risperidone) PS ORAL ORAL Date:02/23/00ISR Number: 3467211-3Report Type:Periodic Company Report #JRFUSA1999001234 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Risperdal (Tablet) Initial or Prolonged Hypotension (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Lorazepam (Lorazepam) C Date:02/23/00ISR Number: 3467285-XReport Type:Periodic Company Report #JRFUSA1999001259 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Risperdal (Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL ORAL Date:02/23/00ISR Number: 3467286-1Report Type:Periodic Company Report #9919846 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Zoloft Tablets PS ORAL 50.00 MG: Professional TOTAL: DAILY: ORAL Risperdal SS ORAL 2.00 MG TOTAL: BID: ORAL Benadryl C Date:02/23/00ISR Number: 3467293-9Report Type:Periodic Company Report #JRFUSA1999001298 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Consumer Risperdal (1 Mg Initial or Prolonged Urinary Incontinence Tablet) (Risperidone) PS ORAL 3 MG, 2 IN 1 DAY (S) ORAL Doxepin (Doxepin) C 22-Feb-2006 08:20 AM Page: 734 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote (Valproate Semisodium) C Prilosec (Omeprazole) C Centrum (Centrum) C Atrovent (Ipratropium Bromide) C Coreg (Carvedilol) C Lopressor (Metoprolol Tartrate) C Darvocet (Darvocet) C Ambien (Zolpidem Tartrate) C Asa (Acetylsalicylic Acid) C Valium (Diazepam) C Verapamil (Verapamil) C Celexa (Citalopram Hydrobromide) C Motrin C Iron (Iron) C (Glucotrol (Glipizide) C Montelukast (Montelukast) C Intal (Cromoglicate Sodium) C Ventolin (Salbutamol) C Date:02/23/00ISR Number: 3467297-6Report Type:Periodic Company Report #JRFUSA1999001325 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal (Tablet) Initial or Prolonged Syndrome Professional (Risperidone) PS ORAL ORAL Required Suicide Attempt Intervention to Prevent Permanent Impairment/Damage Date:02/23/00ISR Number: 3467300-3Report Type:Periodic Company Report #JRFUSA1999001352 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Consumer Risperdal (2 Mg Initial or Prolonged Tablet) (Risperidone) PS ORAL 5 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 735 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3467305-2Report Type:Periodic Company Report #JRFUSA1999001399 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hyperglycaemia Health Risperdal (1 Mg Required Pyrexia Professional Tablet) Intervention to Renal Impairment (Risperidone) PS ORAL 1 MG, 2 IN 1 Prevent Permanent Sedation DAY (S) ORAL Impairment/Damage Sudden Death SEE IMAGE Ativan (Lorazepam) SS ORAL 1 MG, 3 IN 1 DAY (S) ORAL Zoloft (Sertraline Hydrochloride) SS ORAL 50 MG, 1 IN 1 DAY, ORAL Date:02/23/00ISR Number: 3467309-XReport Type:Periodic Company Report #JRFUSA1999001464 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Risperdal (1 Mg Initial or Prolonged Tablet) (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY(S), ORAL Date:02/23/00ISR Number: 3467313-1Report Type:Periodic Company Report #JRFUSA1999001483 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, 2 IN 1 DAY(S) ORAL Zoloft (Sertraline Hydrochloride) SS ORAL 50 MG 1 IN 1 DAY(S), ORAL Depakote (Valproate Semisodium) SS ORAL 500 MG, 3 IN 1 DAY (S) , ORAL Date:02/23/00ISR Number: 3467319-2Report Type:Periodic Company Report #JRFUSA1999001632 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (4 Mg Initial or Prolonged Hypokinesia Tablet) Tremor (Risperidone) PS ORAL 4 MG , 1 IN 1 DAY(S), ORAL Seroquel (Seroquel) C Date:02/23/00ISR Number: 3467323-4Report Type:Periodic Company Report #JRFUSA1999001758 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Consumer Risperdal (1 Mg Initial or Prolonged Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 736 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haldol (Tablet ) (Haloperidol) C Depakote (Valproate Semisodium) C Serzone(Nefazodone Hydrochloride) C Date:02/23/00ISR Number: 3467326-XReport Type:Periodic Company Report #JRFUSA1999001782 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Risperdal (1 Mg Initial or Prolonged Fatigue Tablet) Suicide Attempt (Risperidone) PS ORAL 0.5 MG , 3 IN 1 DAY(S), ORAL Risperdal (1 Mg Tablet) (Risperidone) SS Wellbutrin (Amfebutamone Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Antihypersensitive Nos (Antihypersensitives ) C Date:02/23/00ISR Number: 3467332-5Report Type:Periodic Company Report #JRFUSA1999001783 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Risperdal (Tablet) Initial or Prolonged Hypertonia (Risperidone) PS ORAL 1 MG, 2 IN 1 Sedation DAY (S) ORAL Stupor Risperdal (Tablet) (Risperidone) SS ORAL 0.5 MG , 3 IN 1 DAY (S) ORAL Risperdal (Tablet) (Risperidone) SS ORAL 1.25 MG, DAILY, ORAL Aricept (Donepezil Hydrochloride) C Synthroid (Levothyroxine Sodium) C Glipizide (Glipizide) C Date:02/23/00ISR Number: 3467336-2Report Type:Periodic Company Report #JRFUSA1999001910 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (3 Mg Initial or Prolonged Tablet) (Risperidone) PS ORAL 6 MG, 2 IN 1 22-Feb-2006 08:20 AM Page: 737 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY(S), ORAL Luvox (Fluvoxamine Maleate) C Date:02/23/00ISR Number: 3467341-6Report Type:Periodic Company Report #JRFUSA1999001916 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Condition Aggravated Health Risperdal (Tablet) Tardive Dyskinesia Professional (Risperidone) PS ORAL 2.5 MG, DAILY, ORAL Risperdal (Tablet) (Risperidone) SS ORAL 3 MG, DAILY, ORAL Date:02/23/00ISR Number: 3467345-3Report Type:Periodic Company Report #JRFUSA1999002007 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (Tablet) Initial or Prolonged Insomnia (Risperidone) PS ORAL ORAL Tremor Risperdal (Tablet) (Risperidone) SS ORAL 12 MG, DAILY , ORAL Risperdal (Tablet) ( Risperidone ) SS ORAL 2 MG, DAILY , ORAL Risperdal (Tablet) (Risperidone) SS ORAL 3 MG, 2 IN 1 DAY (S) ORAL Depakote (Valproate Semisodium) C Zyprexa (Olanzapine) C Date:02/23/00ISR Number: 3467351-9Report Type:Periodic Company Report #JRFUSA1999002087 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Health Risperdal (Tablet) Initial or Prolonged Speech Disorder Professional Risperidone PS ORAL 1 MG 2 IN 1 Tongue Discolouration DAY(S) ORAL 5 DAY Tongue Oedema Risperdal (Tablet ) (Risperidone) SS ORAL 2 MG, 2 IN 1 DAY (S) ORAL Risperdal (Tablet) (Risperidone) SS ORAL 2 MG, 2 IN 1 DAY (S) ORAL Risperdal (Tablet) (Risperidone) SS Date:02/23/00ISR Number: 3467359-3Report Type:Periodic Company Report #JRFUSA1999002088 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (3 Mg Initial or Prolonged Tablet) (Risperidone) PS ORAL 3 MG, 2 IN 1 DAY (S) , 22-Feb-2006 08:20 AM Page: 738 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Ambien (Zolpidem Tartrate) C Date:02/23/00ISR Number: 3467393-3Report Type:Periodic Company Report #JRFUSA1999002093 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chills Consumer Risperdal (Tablet) Headache (Risperidone) PS ORAL ORAL Hyperhidrosis Zoloft (Sertraline Suicide Attempt Hydrochloride) C Decongestant (Decongestants And Antiallergics) C Diabetic Medication (Drug Used In Diabetes) C Hypertensive Medication (Antihypertensives) C Date:02/23/00ISR Number: 3467408-2Report Type:Periodic Company Report #JRFUSA1999002109 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Torticollis Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, DAILY , ORAL 3 MON Prozac (Fluoxetine Hydrochloride) C Date:02/23/00ISR Number: 3467409-4Report Type:Periodic Company Report #JRFUSA1999002110 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Risperdal (Tablet) Initial or Prolonged Hyponatraemia Professional (Risperidone) PS ORAL 5 MG, DAILY, ORAL Benadryl (Diphenhydramine Hydrochloride) C Date:02/23/00ISR Number: 3467415-XReport Type:Periodic Company Report #JRFUSA1999002284 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Risperdal (Tablet) Initial or Prolonged Condition Aggravated (Risperidone) PS ORAL 2 MG, 2 IN 1 Insomnia DAY(S), ORAL Risperdal (Tablet) (Risperidone) SS ORAL 3 MG, 2 IN 1 DAY(S), ORAL Effexor (Venlafaxine Hydrochloride) C Celebrex (Celecoxib) C Ambien (Zolpidem 22-Feb-2006 08:20 AM Page: 739 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tartrate) C Date:02/23/00ISR Number: 3468244-3Report Type:Periodic Company Report #JAUSA35361 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Risperdal Initial or Prolonged Professional (Risperidone) PS ORAL ORAL Remeron C Date:02/23/00ISR Number: 3468249-2Report Type:Periodic Company Report #JAUSA35364 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (Tablet) Initial or Prolonged Ejaculation Failure Professional (Risperidone) PS ORAL 6 MG, 1 IN 1 Libido Decreased DAY (S), ORAL Depakote C Date:02/23/00ISR Number: 3468251-0Report Type:Periodic Company Report #JAUSA35395 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Risperdal Initial or Prolonged Extrapyramidal Disorder Professional (Risperidone) PS (.5 MG 1 Hypokinesia DAILY Sedation 29-NOV-98): HS Haldol (Haloperidol) SS INTRAVENOUS 15 MG, 1 IN 1 TIME (S), IV Date:02/23/00ISR Number: 3468256-XReport Type:Periodic Company Report #JAUSA35434 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Risperdal Initial or Prolonged Professional (Risperidone) PS ORAL ORAL Remeron C Date:02/23/00ISR Number: 3468260-1Report Type:Periodic Company Report #JAUSA35440 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertonia Health Risperdal Initial or Prolonged Therapeutic Response Professional (Risperidone) PS ORAL ORAL Required Increased Intervention to Prevent Permanent Impairment/Damage Date:02/23/00ISR Number: 3468263-7Report Type:Periodic Company Report #JAUSA35494 Age:40 YR Gender:Male I/FU:I Outcome PT Hospitalization - Diabetes Mellitus Initial or Prolonged Fatigue 22-Feb-2006 08:20 AM Page: 740 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Polyuria Thirst Report Source Product Role Manufacturer Route Dose Duration Health Risperdal Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY (S), ORAL Date:02/23/00ISR Number: 3468267-4Report Type:Periodic Company Report #JAUSA35546 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Risperdal (Tablet 2 Initial or Prolonged Depression Professional Mg) (Risperidone) PS SEE IMAGE Dyskinesia Cozaar C Hypokalaemia Isopto-Carbachol C Laboratory Test Abnormal Alphagan C Date:02/23/00ISR Number: 3468270-4Report Type:Periodic Company Report #JAUSA35550 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (Tablet 1 Initial or Prolonged Dyspnoea Professional Mg ) (Risperidone) PS (1.5 MG DAILY Leukopenia 15-APR-98): Pneumonia 0.5 MG IN AM, 1 MG IN PM, ESTIMATED Procrit C Synthroid C Calcium C Lanoxin C Insulin C Date:02/23/00ISR Number: 3468277-7Report Type:Periodic Company Report #JAUSA35570 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Choreoathetosis Health Risperdal (Tablet) Initial or Prolonged Condition Aggravated Professional (Risperidone) PS SEE IMAGE Dyskinesia Seroquel Gynaecomastia (Quetiapine) SS (08-NOV-98): Weight Decreased ESTIMATED STOP DATE Lithium C Prozac C Date:02/23/00ISR Number: 3468280-7Report Type:Periodic Company Report #JAUSA35645 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Risperdal (Tablet) Initial or Prolonged Aphasia (Risperidone) PS SEE IMAGE Gait Disturbance Ativan C Tremor 22-Feb-2006 08:20 AM Page: 741 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3468285-6Report Type:Periodic Company Report #JAUSA35705 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (Tablet 1 Initial or Prolonged Delirium Professional Mg) (Risperidone) PS 1 MG 1 DAILY SEE IMAGE Aricept C Folic Acid C Date:02/23/00ISR Number: 3468289-3Report Type:Periodic Company Report #JAUSA35768 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Risperdal (Tablet) Initial or Prolonged Agitation Professional (Risperidone) PS ORAL 10 MG, DAILY, Condition Aggravated ORAL Drug Interaction Tegretol (Tablet) Drug Level Above (Carbamazepine) SS ORAL 1000 MG, Therapeutic DAILY, ORAL Drug Level Below Luvox (Fluvoxamine Therapeutic Maleate) SS ORAL 200 MG, DAILY, ORAL Mellaril (Thioridazine Hydrochloride) SS ORAL PRN, ORAL Depakote C Cogentin C Mysoline C Date:02/23/00ISR Number: 3468294-7Report Type:Periodic Company Report #JAUSA35797 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscular Weakness Health Risperdal (Tablet 2 Initial or Prolonged Neuroleptic Malignant Professional Mg) (Risperidone) PS ORAL SEE IMAGE Syndrome Buspar C Tachycardia Glyburide C Ciprofloxacin C Trazodone C Date:02/23/00ISR Number: 3468298-4Report Type:Periodic Company Report #JAUSA35829 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Risperdal (Tablet 2 Initial or Prolonged Mg) (Risperidone) PS (4 MG 2 DAILY 15-JUN-97): ESTIMATED START DATE Propulsid C Colace C Senokot C Prilosec C Cogentin C Paxil C Vistaril C K-Du C Darvocet C 22-Feb-2006 08:20 AM Page: 742 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3468302-3Report Type:Periodic Company Report #JAUSA35853 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Initial or Prolonged Syndrome Professional (Risperidone) PS ORAL ORAL Date:02/23/00ISR Number: 3468308-4Report Type:Periodic Company Report #JAUSA35879 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Risperdal (Tablet) Initial or Prolonged Agitation (Risperidone) PS SEE IMAGE Other Anorexia Zinc C Required Arthralgia Vitamin C C Intervention to Arthropathy Multi Vitamin C Prevent Permanent Condition Aggravated Impairment/Damage Conjunctivitis Constipation Depression Diarrhoea Erectile Dysfunction Fatigue Headache Hypertonia Melaena Osteoarthritis Pain In Extremity Pyrexia Sedation Stupor Suicide Attempt Thinking Abnormal Weight Decreased Date:02/23/00ISR Number: 3468311-4Report Type:Periodic Company Report #JAUSA35899 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Risperdal (Tablet) Initial or Prolonged Dermatitis Bullous (Risperidone) PS (30-JUN-97): Insomnia ESTIMATED DATES Haldol Decanoas (Haloperidol Decanoate) SS (01-JUL-97): ESTIMATED DATES Benzodiazepines C Date:02/23/00ISR Number: 3468315-1Report Type:Periodic Company Report #JAUSA36012 Age:12 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:20 AM Page: 743 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Risperdal (Tablet 2 Dyspnoea Professional Mg) (Risperidone) PS SEE IMAGE Electrocardiogram Qt Buspar C Prolonged Amitriptyline C Hypertension Hypokalaemia Suicide Attempt Tachycardia Therapeutic Response Increased Date:02/23/00ISR Number: 3468321-7Report Type:Periodic Company Report #JAUSA36015 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Risperdal (1 Mg Initial or Prolonged Condition Aggravated Professional Tablet) Leukopenia (Risperidone) PS ORAL 1 MG, 3 IN 1 DAY (S) ORAL Date:02/23/00ISR Number: 3468324-2Report Type:Periodic Company Report #JAUSA36029 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Health Risperdal (Tablet 2 Initial or Prolonged Professional Mg) (Risperidone) PS ORAL 2 MG, 1 IN 1 Required DAY (S) ORAL Intervention to Nortriptyline Prevent Permanent (Nortriptyline) SS ORAL 50 MG, 1 IN 1 Impairment/Damage DAY (S), ORAL Albuterol C Zantac C Singulair C Cromolyn Sodium C Reglan C Date:02/23/00ISR Number: 3468787-2Report Type:Periodic Company Report #JAUSA34770 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Health Risperdal (Tablet 1 Initial or Prolonged Professional Mg) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY (S), ORAL Depakote (Tablet 250 Mg) (Valproate Sodium) C Anafranil (Tablet 25 Mg) (Clomipramine) C 22-Feb-2006 08:20 AM Page: 744 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/00ISR Number: 3468789-6Report Type:Periodic Company Report #JAUSA35085 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Risperdal (Tablet 2 Initial or Prolonged Drug Effect Decreased Professional Mg) (Risperidone) PS (2 MG 1 DAILY Hypertension 03-SEP-98): Nervousness AT BEDTIME Suicide Attempt Depakote (Tablet 500 Tachycardia Mg) (Valproate Tremor Sodium0 SS (500 MG 1 DAILY): IN THE MORNING Date:02/23/00ISR Number: 3468793-8Report Type:Periodic Company Report #JAUSA36953 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal (Tablet 2 Initial or Prolonged Condition Aggravated Health Mg) (Risperidone) PS (2 MG 2 DAILY Professional 15-APR-98): Haldol Decanoas (Solution 100 Mg/Ml) (Haloperidol Decanoate) SS INTRAMUSCULAR 100 MG, 1 IN 1 MONTH(S), IM Tegretol (Tablet) (Carbamepine) C Cogentin (Tablet) Benzatropine Mesilate C Prozac (Capsules) (Fluoxetine) C Date:02/23/00ISR Number: 3468796-3Report Type:Periodic Company Report #JRFUSA1999002721 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Risperdal Initial or Prolonged Condition Aggravated Professional (Unspecified) Drug Abuser (Risperidone) PS ORAL 8 MG, DAILY, ORAL Phencyclidine (Phencyclidine) SS ORAL ORAL Fluoxetine (Fluoxetine) C Clonazepam (Clonzepam) C Date:02/23/00ISR Number: 3468799-9Report Type:Periodic Company Report #JRFUSA1999002915 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (Tablet) Initial or Prolonged Drug Abuser (Risperidone) PS ORAL 1 TABLE, DAILY, ORAL Vistaril (Hydroxyzine 22-Feb-2006 08:20 AM Page: 745 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Embonate) C Klonopin (Clonazepam) C Date:02/23/00ISR Number: 3468802-6Report Type:Periodic Company Report #JRFUSA1999001463 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Health Risperdal Professional (Unspecified) (Risperidone) PS Date:02/23/00ISR Number: 3468805-1Report Type:Periodic Company Report #JRFUSA1999000081 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradykinesia Risperdal (Tablet) (Risperidone) PS ORAL 2 MG, 1 IN 1 DAY(S), ORAL Diphenhydramine (Diphenhydramine) C Date:02/23/00ISR Number: 3469588-1Report Type:Periodic Company Report #9906995 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Health Zoloft Tablets PS ORAL ORAL Professional Risperidal SS Date:02/23/00ISR Number: 3469916-7Report Type:Periodic Company Report #9941411 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Zoloft Tablets PS ORAL 200.00 MG Deficit/Hyperactivity Professional TOTAL: DAILY: Disorder ORAL Drug Interaction Cylert SS ORAL 75.00 MG Emotional Disorder TOTAL: DAILY Hostility : ORAL Risperdal SS ORAL 3.00 MG TOTAL: DAILY: ORAL Date:02/24/00ISR Number: 3462689-3Report Type:Expedited (15-DaCompany Report #A001638 Age:87 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Consumer Zoloft Tablets PS 50.00 MG Intervention to Dementia Alzheimer'S Type Health TOTAL:DAILY Prevent Permanent Depression Professional Celebrex SS Impairment/Damage Dizziness Risperdal SS Haematochezia Toprol Xl C Haemoglobin Decreased Quinine Sulfate C Hallucination Prilosec C Lethargy Furosemide C Oral Intake Reduced Captopril C Speech Disorder 22-Feb-2006 08:20 AM Page: 746 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/00ISR Number: 3463508-1Report Type:Direct Company Report # Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Risperdal 2mg Qid PS 4 YR Initial or Prolonged Lethargy Benadryl C Pneumonia Aspiration Synthroid C Pyrexia Diffican C Valmin C Topramil C Ultram C Date:02/28/00ISR Number: 3464451-4Report Type:Expedited (15-DaCompany Report #JRFUSA1999003665 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abnormal Behaviour Consumer Risperdal (Tablet) Accident (Risperidone) PS ORAL 8 MG, DAILY, Hallucination, Auditory ORAL Impaired Healing Seroquel (Seroquel) C Injury Depakote (Valproate Pain In Extremity Semisodium) C Thinking Abnormal Navane (Tiotixene) C Vioxx (Rofecoxib) C Oxycodone (Oxycodone) C Colace (Docusate Sodium) C Elavil (Amitriptyline Hydrochloride) C Cogentin (Benzatropine Mesilate) C Prilosec (Omeprazole) C Date:02/28/00ISR Number: 3464454-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000000279 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperidone (2 Mg Drug Toxicity Health Tablet) Loss Of Consciousness Professional (Risperidone) PS ORAL 2 MG, 3 IN 1 Overdose DAY(S), ORAL Pallor Flunitrazepam Pulmonary Oedema (Flunitrazepam) SS ORAL 1 MG, 1 IN 1 NIGHT(S), ORAL Date:02/28/00ISR Number: 3464455-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000000842 Age:58 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Coma Haematuria Hypotonia 22-Feb-2006 08:20 AM Page: 747 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Proteinuria Pyrexia Rhabdomyolysis Report Source Product Role Manufacturer Route Dose Duration Urea Urine Increased Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Date:02/28/00ISR Number: 3464457-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000000399 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bulimia Nervosa Foreign Risperdal Initial or Prolonged Condition Aggravated Health (Unspecified) Gastric Dilatation Professional (Risperidone) PS ORAL MG, DAILY, Respiratory Disorder ORAL Atarax (Hydroxyzine Hydrochloride) SS Date:02/28/00ISR Number: 3464468-XReport Type:Expedited (15-DaCompany Report #JAOCAN2000000118 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Antinuclear Antibody Foreign Risperdal Positive Health (Unspecified) Complement Factor Professional (Risperidone) PS ORAL DAILY, ORAL Decreased Company Chloral Hydrate Dyspnoea Representative (Chloral Hydrate) C Interstitial Lung Disease Systemic Lupus Erythematosus Date:02/28/00ISR Number: 3464471-XReport Type:Expedited (15-DaCompany Report #JACFRA2000000135 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal (1 Mg Initial or Prolonged Health Tablet) Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Fragmin (Heparin-Fraction, Sodium Salt) C Diantalvic (Diantalvic) C Augmentin (Clavulin) C Athymil (Mianserin Hydrochloride) C Kardegic (Acetylsalicylate Lysine) C Atrovent (Ipratropium Bromide) C Solucort (Prednisolone) C Oropivalone (Oropivalone) C 22-Feb-2006 08:20 AM Page: 748 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Didronel (Etidronate Disodium) C Cordipath (Glyceryl Trinitrate) C Kaleorid (Potassium Chloride) C Imovane (Zopiclone) C Dafalgan (Paracetamol) C Discotrine (Glyceryl Trinitrate) C Date:02/28/00ISR Number: 3464474-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000000398 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Disorder Foreign Risperidone (Tablet) Sick Sinus Syndrome Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Lithium Carbonate (Lithium Carbonate) C Date:02/28/00ISR Number: 3464476-9Report Type:Expedited (15-DaCompany Report #JACGER2000000222 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal (Tablet) Initial or Prolonged Health (Risperidone) PS ORAL SEE IMAGE Professional Haldol (Tablet) (Haloperidol) SS ORAL SEE IMAGE Leponex (Clozapine) SS ORAL SEE IMAGE Ciatyl-Z (Zuclopenthixol Hydrochloride) SS ORAL MG, ORAL Taxilan (Perazine) SS MG, DAILY; MG, DAILY Tavor (Lorazepam) SS SEE IMAGE Sulp (Sulpiride) SS ORAL SEE IMAGE Akineton (Biperiden Hydrochloride) C Date:02/28/00ISR Number: 3464477-0Report Type:Expedited (15-DaCompany Report #JRFBEL2000000357 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Deafness Foreign Risperdal (Tablet) Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Date:02/28/00ISR Number: 3465521-7Report Type:Expedited (15-DaCompany Report #WAES 00021654 Age:7 MON Gender: I/FU:I Outcome PT Congenital Anomaly Complications Of Maternal Exposure To Therapeutic Drugs Convulsion 22-Feb-2006 08:20 AM Page: 749 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Developmental Delay Foetal Distress Syndrome Induced Labour Report Source Product Role Manufacturer Route Dose Duration Premature Baby Tab Cogentin Unk PS ORAL PO Tab Risperdal 8 Mg SS ORAL 8 MG/DAILY/PO Prozac Unk SS ORAL PO Date:02/29/00ISR Number: 3465869-6Report Type:Expedited (15-DaCompany Report #HQ1152922FEB2000 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Study Tavor (Lorazepam) PS ORAL "2 MG, 8 MG, Initial or Prolonged Health 0.5 MG" ORAL 62 DAY Other Professional Ciatyl (Clopenthixol Hydrochloride) SS 600 MG 1X PER 1 DAY 1 DAY Clozapine (Clozapine0 SS 100 MG-250 MG DAILY 15 DAY Haldol (Haloperidol) SS 5 MG - 50 MG DAILY 26 DAY Risperdal (Risperidone) SS 2MG - 4 MG DAILY 5 DAY Sulpiride (Sulpiride) SS 100 MG - 200 MG DAILY 5 DAY Taxilan (Perazine) C 100 MG - 200 MG DAILY Akineton C Date:02/29/00ISR Number: 3465891-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000000172 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amenorrhoea Foreign Haldol (Tablet) Initial or Prolonged Hyperprolactinaemia Health (Haloperidol) PS ORAL MG, DAILY, Pituitary Tumour Professional ORAL Risperidone (Tablet) (Risperidone) SS ORAL MG, DAILY, ORAL Flunitrazepam (Flunitrazepam) C Mianserin Hydrochloride (Mianserin Hydrochloride) C Chlordiazepoxide (Chlordiazepoxide) C Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C 22-Feb-2006 08:20 AM Page: 750 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/29/00ISR Number: 3465897-0Report Type:Expedited (15-DaCompany Report #JACGER2000000222 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Haldol (Tablet) Initial or Prolonged Health (Haloperidol) PS ORAL SEE IMAGE Professional Leponex (Clozapine) SS ORAL SEE IMAGE Ciatyl-Z (Zuclopenthixol Hydrochloride) SS MG, DAILY Taxilan (Perazine) SS ORAL SEE IMAGE Tavor (Lorazepam) SS SEE IMAGE Sulp (Sulpiride) SS ORAL SEE IMAGE Risperidal (Tablet) (Risperidone) SS ORAL SEE IMAGE Akineton (Biperiden Hydrochloride) C Date:02/29/00ISR Number: 3465902-1Report Type:Expedited (15-DaCompany Report #JACFRA2000000136 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Attention Foreign Haldol (Unspecified) Hospitalization - Deficit/Hyperactivity Health (Haloperidol) PS ORAL ORAL Initial or Prolonged Disorder Professional Risperdal (1 Mg Cardiac Arrest Company Tablet) Coma Representative (Risperidone) SS ORAL SEE IMAGE Infection Tranxene Labile Blood Pressure (Clorazepate Pyrexia Dipotassium) SS ORAL ORAL Tiapridal (Tiapride) SS ORAL ORAL Date:02/29/00ISR Number: 3466012-XReport Type:Direct Company Report # Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Health Risperidone 3mg Bid PS 3MG BID Headache Professional Restlessness Tremor Date:03/01/00ISR Number: 3466212-9Report Type:Direct Company Report # Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Risperdal 2mg Q Am, Intervention to Eyelid Ptosis 1mg Q1300 PS 2MG Q AM, 1MG Prevent Permanent Muscle Rigidity Q 1300 Impairment/Damage Sedation Cogentin C Date:03/01/00ISR Number: 3466924-7Report Type:Expedited (15-DaCompany Report #A006008 Age: Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:20 AM Page: 751 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Consumer Navane Capsules PS ORAL ORAL Risperidone SS Date:03/01/00ISR Number: 3466959-4Report Type:Expedited (15-DaCompany Report #A005496 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Consumer Zoloft Tablets PS ORAL DAILY ORAL Initial or Prolonged Fluctuation Luvox SS ORAL ORAL Required Cardiac Disorder Risperdal SS ORAL ORAL Intervention to Clonic Convulsion Florinef C Prevent Permanent Feeling Abnormal Vitamins C Impairment/Damage Feeling Hot Acidophyllus C Headache Tylenol C Heart Rate Irregular Ibuprofen C Heat Exhaustion Aspirin C Malaise Nausea Orthostatic Hypotension Paraesthesia Serotonin Syndrome Tic Tourette'S Disorder Tremor Weight Decreased Weight Increased Date:03/01/00ISR Number: 3467062-XReport Type:Expedited (15-DaCompany Report #FLUV00399000016 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrial Fibrillation Foreign Fevarin PS ORAL 50 MG DAILY Hospitalization - Bundle Branch Block Right Health PO, 100 MG Initial or Prolonged Circulatory Collapse Professional DAILY PO, 50 Deep Vein Thrombosis Other MG TID PO Dyspnoea Risperdal SS 4 MG DAILY Hypotension Cisday C Pulmonary Embolism Amaryl C Tachyarrhythmia Bifiteral C Isoglaucon C Trusopt C Date:03/01/00ISR Number: 3467190-9Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dialysis Health Quetiapine PS ORAL 50 MG QHS Hospitalization - Renal Failure Professional ORAL Initial or Prolonged Risperidone SS ORAL 1MG QHS ORAL Disability 22-Feb-2006 08:20 AM Page: 752 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/00ISR Number: 3467241-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000000344 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Polycythaemia Vera Study Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Atenolol (Atenolol) C Clonazepam (Clonazepam) C Cogentin (Benzatropine Mesilate) C Date:03/01/00ISR Number: 3467509-9Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Risperdal 3 Mg PS 3MG BID; 3MG Increased HS Catatonia Depakene C Concussion Cogentin C Depression Benadrl C Dysthymic Disorder Gait Disturbance Intentional Self-Injury Lethargy Muscle Rigidity Waxy Flexibility Date:03/02/00ISR Number: 3467144-2Report Type:Direct Company Report # Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Amenorrhoea Risperadone PS DIFFERENT Life-Threatening Drug Withdrawal Syndrome DOSES Disability Influenza Like Illness Other Insomnia Required Tardive Dyskinesia Intervention to Weight Increased Prevent Permanent Impairment/Damage Date:03/02/00ISR Number: 3469467-XReport Type:Expedited (15-DaCompany Report #JRFUSA2000000871 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Zyprexa (Olanzapine) SS Benzatropine Mesilate SS 22-Feb-2006 08:20 AM Page: 753 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/00ISR Number: 3469188-3Report Type:Direct Company Report # Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Celexa (20mg Qd) PS ORAL 20MG PO QD 4 MON Initial or Prolonged Risperidone (1mg Qd) SS ORAL 1MG PO QD 5 MON Depakote C Date:03/06/00ISR Number: 3470411-XReport Type:Expedited (15-DaCompany Report #JAUSA37062 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Risperdal (3 Mg Initial or Prolonged Delusion Tablet) Dyspnoea (Risperidone) PS Head Injury Buspar (Tablet 15 Heart Rate Increased Mg) (Buspirone) C Memory Impairment Serzone (Tablet 100 Musculoskeletal Stiffness Mg) (Nefazodone) C Paranoia Road Traffic Accident Weight Increased Date:03/06/00ISR Number: 3470591-6Report Type:Expedited (15-DaCompany Report #JACGER2000000243 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Haemolytic Foreign Risperdal (Tablet) Initial or Prolonged Autoimmune Health (Risperidone) PS ORAL DAILY, ORAL Cardiovascular Disorder Professional Zoloft (Sertraline Hydrochloride) SS ORAL ORAL Date:03/06/00ISR Number: 3470630-2Report Type:Expedited (15-DaCompany Report #JRFUSA1999004310 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Health Risperdal (0.5 Mg Initial or Prolonged Bronchitis Professional Tablet) Required Cardiac Failure (Risperidone) PS ORAL 0.5 MG 2 IN 1 Intervention to Congestive DAY(S) ORAL Prevent Permanent Cerebrovascular Accident Depakote (Valproate Impairment/Damage Semisodium) C Cardizem (Diltiazem Hydrochloride) C Unspecified (Unspecified) C Date:03/06/00ISR Number: 3470632-6Report Type:Expedited (15-DaCompany Report #JACGER1999000624 Age:64 YR Gender:Female I/FU:F Outcome PT Life-Threatening Blood Creatine Hospitalization - Phosphokinase Increased Initial or Prolonged Dehydration Ecchymosis Fall Haemorrhagic Stroke Hyponatraemia 22-Feb-2006 08:20 AM Page: 754 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inappropriate Antidiuretic Hormone Secretion Report Source Product Role Manufacturer Route Dose Duration Polyuria Foreign Risperdal (Tablet) Pyrexia Health (Risperidone) PS ORAL MG DAILY ORAL Sedation Professional Date:03/06/00ISR Number: 3470633-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000000398 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Decreased Foreign Risperidone (Tablet) Bradycardia Health (Risperidone) PS ORAL MG DAILY ORAL Drug Interaction Professional Lithium Carbonate Sick Sinus Syndrome (Lithium Carbonate) SS ORAL MG DAILY ORAL Fluvoxamine Maleate (Fluvoxamine Maleate) SS ORAL MG DAILY ORAL Magnesium Oxide (Magnesium Oxide) C Date:03/06/00ISR Number: 3470636-3Report Type:Expedited (15-DaCompany Report #JAFIN37709 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal (Capsules) Initial or Prolonged Study (Risperidone) PS (2 MG DAILY Health 18-NOV-97) : Professional 2 CAPSULES SEE IMAGE Flixonase (Fluticasone) C Duact (Duact) C Tenox (Temazepam) C Date:03/06/00ISR Number: 3470657-0Report Type:Expedited (15-DaCompany Report #JRFBEL2000000432 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Thyroid Stimulating Foreign Risperdal (1 Mg Hormone Increased Health Tablet) Hypothermia Professional (Risperidone) PS ORAL 1 MG 2 IN 1 Myocardial Ischaemia DAY(S) ORAL Magnesium Hydroxide (Magnesium Hydroxide) C Oxazepam (Oxazepam) C Paracetamol (Paracetamol) C Date:03/06/00ISR Number: 3470662-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000000484 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Risperdal Water Intoxication Health (Unspecified) Professional (Risperidone) PS ORAL MG ,DAILY, 22-Feb-2006 08:20 AM Page: 755 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Sodium Valproate (Valproate Sodium) SS Unspecified Medication Regimen (Unspecified) SS Date:03/06/00ISR Number: 3470676-4Report Type:Expedited (15-DaCompany Report #JRFUSA2000001027 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Cancer Recurrent Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG 2 IN 1 DAY(S) ORAL Date:03/06/00ISR Number: 3470680-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000001080 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gamma-Glutamyltransferase Health Risperdal (3 Mg Increased Professional Tablet) Leukopenia (Risperidone) PS ORAL 3 MG 2 IN 1 DAY(S) ORAL Ritalin (Methylphenidate Hydrochloride) C Cogetin (Benzatropine Mesilate) C Date:03/06/00ISR Number: 3471244-0Report Type:Expedited (15-DaCompany Report #JRFUSA2000001013 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Health Risperdal (0.5 Mg Initial or Prolonged Complete Professional Tablet) Blood Pressure Increased (Risperidone) PS ORAL 0.5 MG, 1 IN Dermatitis Bullous 1 DAY(S), Dermatitis Exfoliative ORAL Electrocardiogram Q Waves Electrocardiogram Qt Prolonged Lethargy Rash Erythematous Rash Generalised Rash Pruritic Date:03/06/00ISR Number: 3471292-0Report Type:Expedited (15-DaCompany Report #JACGBR1999000601 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Foreign Risperdal Initial or Prolonged Cerebral Infarction Health (Unspecified) Cerebral Ischaemia Professional (Risperidone) PS ORAL MG, 1 IN 1 Cerebrovascular Disorder NIGHT(S), Paralysis ORAL Paroxetine 22-Feb-2006 08:20 AM Page: 756 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Paroxetine) C Fursemide (Furosemide) C Prednisolone (Prednisolone) C Ismo (Isosorbide Mononitrate) C Azathioprine (Azathioprine) C Zopiclone (Zopiclone) C Cyclosporin (Ciclosporin) C Date:03/08/00ISR Number: 3472125-9Report Type:Expedited (15-DaCompany Report #00-02-0070 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Clozapine -Zenith Initial or Prolonged Hyponatraemia Professional Goldline PS ORAL 125MG ORAL Leukocytosis Seroquel Tablets SS Lower Limb Fracture Risperdal Tablets SS ORAL ORAL Pneumonia Aspiration Respiratory Distress Date:03/08/00ISR Number: 3472277-0Report Type:Expedited (15-DaCompany Report #JAOCAN2000000141 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Risperdal (Tablet) Initial or Prolonged Health (Risperidone) PS ORAL 0.5 MG, 2 IN Required Professional 1 DAY(S), Intervention to ORAL Prevent Permanent Apresoline Impairment/Damage (Hydralazine Hydrochloride) SS ORAL DAILY ORAL Date:03/08/00ISR Number: 3472278-2Report Type:Expedited (15-DaCompany Report #JACGBR1999000372 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Leukopenia Foreign Risperdal Rheumatoid Arthritis Health (Tablet)(Risperidone Professional ) PS ORAL 1 MG, 2 IN 1 DAY(S), ORAL Risperdal (Tablet) (Risperidone) SS ORAL 0.5 MG, 2 IN 1 DAY(S),ORAL Temazepam (Temazepan) C Thyroxine (Levothyroxine Sodium) C Amlodipine (Amlodipine)C C Sodium Valproate (Valproate Sodium) C Prednisolone (Prednisolone) C 22-Feb-2006 08:20 AM Page: 757 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ranitidine (Ranitidine) C Coproxamol (Aporex) C Calcichew (Calcium Carbonate) C Date:03/09/00ISR Number: 3472169-7Report Type:Direct Company Report # Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Gynaecomastia Risperidone 2mg PS ORAL 2MG BID ORAL Intervention to Gabapentin C Prevent Permanent Clonidine C Impairment/Damage Date:03/09/00ISR Number: 3473521-6Report Type:Expedited (15-DaCompany Report #230027 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Inappropriate Foreign Valium Tablets Initial or Prolonged Antidiuretic Hormone Other (Diazepam) 10 Mg PS ORAL 300 MG MG 1 Secretion PER 1 ONE Intentional Overdose DOSE ORAL Pyrexia Imovane (Zopiclone) Rhabdomyolysis 7.5 Mg SS ORAL 150 MG 1 PER Urine Osmolarity 1 ONE DOSE Decreased ORAL Neuleptil (Periciazine) 10 Mg SS ORAL ORAL Risperdal (Risperidone) 4 Mg SS ORAL 120 MG 1 PER 1 ONE DOSE ORAL Date:03/09/00ISR Number: 3473541-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000000095 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal (Tablet) Initial or Prolonged Arthralgia (Risperidone) PS ORAL 3 MG, 2 IN 1 Required Asthenia DAY (S), ORAL Intervention to Cardiac Arrest Risperdal (Tablet) Prevent Permanent Chest Pain (Risperidone) SS ORAL 7 MG, Impairment/Damage Condition Aggravated DAILY,ORAL Difficulty In Walking Risperdal (Tablet) Drug Withdrawal Syndrome (Risperidone) SS ORAL 6 MG, DAILY, Headache ORAL Joint Stiffness Risperdal (Tablet) Memory Impairment (Risperidone) SS ORAL 7.5 MG, Overdose DAILY, ORAL Parkinsonism Risperdal (Tablet) Psychiatric Symptom (Risperidone) SS ORAL 8.5 MG, Pulse Absent DAILY,ORAL Restlessness Haloperidol Sleep Disorder (Haloperidol) SS ORAL 2 MG, 4 IN 1 Tachycardia DAY (S), ORAL Tremor Ativan (Lorazepam) SS ORAL 2 MG, 4 IN 1 Weight Decreased DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 758 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Olanzapine (Olanzapine) C Date:03/09/00ISR Number: 3473553-8Report Type:Expedited (15-DaCompany Report #JRFUSA2000000485 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Risperdal (Tablet) Life-Threatening Hyponatraemia Professional (Risperidone) PS ORAL 0.5 MG, 2 IN Required Inappropriate 1 DAY(S) , Intervention to Antidiuretic Hormone ORAL Prevent Permanent Secretion Risperdal (Tablet) Impairment/Damage Pneumonia Aspiration (Risperidone) SS ORAL 1 MG, 2 IN 1 Posturing DAY(S), ORAL Risperdal (Tablet) (Risperidone) SS ORAL 3 MG, 1 IN 1 DAY(S), ORAL Zoloft (Sertraline Hydrochloride) C Date:03/10/00ISR Number: 3473545-9Report Type:Expedited (15-DaCompany Report #JAUSA36761 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accommodation Disorder Health Risperdal (4 Mg Initial or Prolonged Asthenia Professional Tablet) Cataract (Risperidone) PS ORAL 4 MG, 2 IN 1 Chest Discomfort DAY (S), ORAL Condition Aggravated Seroquel (Seroquel) SS ORAL 100 MG, 3 IN Depression 1 DAY (S), Disturbance In Attention ORAL Eye Disorder Seroquel (Seroquel) SS ORAL 300 MG, 3 IN Face Oedema 1 DAY(S), Pain ORAL Photosensitivity Reaction Artane (Tablet 2 Mg) Psychotic Disorder (Trihexyphenidyl) C Sensation Of Heaviness Paxil (Paroxetine Vision Blurred Hydrochloride) C Visual Disturbance Cogentin Weight Increased (Benzatropine Mesilate) C Date:03/13/00ISR Number: 3474739-9Report Type:Expedited (15-DaCompany Report #DEU001760 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Akineton Retard PS ORAL 4 MG PO Initial or Prolonged Other Stangyl (Trimipramine Maleate) SS ORAL 50 MG PO Risperdal (Risperidone) SS ORAL 6 MG PO 22-Feb-2006 08:20 AM Page: 759 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/13/00ISR Number: 3474791-0Report Type:Expedited (15-DaCompany Report #HQ1292229FEB2000 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Health Efexor (Venlafaxine Chest Pain Professional Hydrochloride) PS ORAL 75 MG 1X PER Syncope 1 DAY ORAL Beloc Zok (Metorolol Succinate) SS ORAL 100 MG 1X PER 1 DAY ORAL Reniten (Enalapril Maleate) SS ORAL 20 MG 1X PER DAY ORAL Risperdal (Risperidone) SS ORAL 2 MG 1X PER DAY ORAL 1 DAY Risperdal (Risperidone) SS ORAL 0.5 MG 1X PER DAY ORAL 22 DAY Risperdal (Risperidone) SS ORAL 4 MG 1X PER DAY ORAL Stilnox (Zolpidem) SS ORAL 10 MG DAILY AS NEEDED ORAL Temesta Tablet (Lorazepam) SS ORAL 1.5 MG 1X PER 1 DAY ORAL Date:03/13/00ISR Number: 3475098-8Report Type:Expedited (15-DaCompany Report #A001638 Age:87 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akinesia Consumer Zoloft PS 50.00 MG Intervention to Anaemia Health TOTAL:DAILY Prevent Permanent Anxiety Professional Celebrex SS Impairment/Damage Aphasia Risperdal SS Condition Aggravated Toprol Xl C Dementia Alzheimer'S Type Quinine Sulfate C Depression Prilosec C Dizziness Furosemide C Haematochezia Captopril C Hallucination Lethargy Oral Intake Reduced Date:03/13/00ISR Number: 3477431-XReport Type:Periodic Company Report #JRFUSA1999002656 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Haldol Decanoate Initial or Prolonged Syndrome Professional (Injection ) Tachycardia (Haloperidol Decanoate) PS INTRAMUSCULAR 1 IN 1 MONTH (S) IM Risperdal (3 Mg Tablet) (Risperidone) SS ORAL 3 MG, 1 IN 1 DAY (S), ORAL 22-Feb-2006 08:20 AM Page: 760 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/14/00ISR Number: 3475631-6Report Type:Expedited (15-DaCompany Report #JRFBEL2000000556 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Literature Risperidone Initial or Prolonged Blood Potassium Decreased Health (Unspecified) Cerebral Atrophy Professional (Risperidone) PS ORAL 2 MG, 2 IN 1 Chorea DAY (S), ORAL Condition Aggravated Citalopram Confusional State (Citalopram) SS MG, DAILY Depression Losartan (Losartan) SS Drug Level Below Carbachol Therapeutic (Carbachol) SS CUTANEOUS CUTANE Drug Withdrawal Syndrome Brimonidine Dyskinesia (Brimonidine) SS Dysphoria Nortriptyline Tardive Dyskinesia (Nortriptyline) SS 25 MG, 1 IN 1 NIGHT (S); 35 MG, 1 IN 1 NIGHT (S) Potassium Chloride (Potassium Chloride) SS MEQ, DAILY Vitamin B12 (Cyanocobalamin) SS ORAL MCG, DAILY, ORAL Zolpidem (Zolpidem) SS 5 MG, PRN Lorazepam (Lorazepam) SS 0.5 MG, 1 IN 2 HOUR (S) Vitamin E (Tocopherol) SS IU, DAILY Clonazepam (Clonazepam) SS 0.25 MG, 2 IN 1 DAY (S); 0.5 MG, 2 IN 1 DAY (S) Date:03/14/00ISR Number: 3475644-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000000546 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Petechiae Foreign Risperidone (Tablet) Thrombocytopenia Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Bromperidol (Unspecified) (Bromperidol) C Promethazine Hydrochloride (Promethazine Hydrochloride) C Date:03/14/00ISR Number: 3475795-4Report Type:Expedited (15-DaCompany Report #JRFUSA2000000095 Age:52 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:20 AM Page: 761 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Aggression Consumer Haloperidol Arthralgia (Haloperidol) PS ORAL 2 MG, 4 IN 1 Asthenia DAY(S), ORAL Cardiac Arrest Risperdal (Tablet) Chest Pain (Risperidone) SS ORAL SEE IMAGE Difficulty In Walking Ativan (Lorazepam) SS ORAL 2 MG, 4 IN 1 Drug Effect Decreased DAY(S), ORAL Drug Withdrawal Syndrome Olanzapine Headache (Olanzapine) C Heart Rate Increased Ill-Defined Disorder Joint Stiffness Memory Impairment Overdose Parkinson'S Disease Peripheral Coldness Pulse Absent Restlessness Sleep Disorder Tachycardia Tremor Weight Decreased Date:03/14/00ISR Number: 3475800-5Report Type:Expedited (15-DaCompany Report #JRFUSA2000001497 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pituitary Tumour Benign Health Haldol (Tablet) Intervention to Professional (Haloperidol) PS ORAL ORAL Prevent Permanent Risperdal (Tablet) Impairment/Damage (Risperidone) SS ORAL 5 MG, DAILY,ORAL Date:03/15/00ISR Number: 3475514-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Death Of Relative Risperdal 1 Mg Bid PS Intervention to Simple Partial Seizures Prevent Permanent Impairment/Damage Date:03/15/00ISR Number: 3475918-7Report Type:Expedited (15-DaCompany Report #JRFUSA2000001604 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Clozapine (Clozapine) SS 22-Feb-2006 08:20 AM Page: 762 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/00ISR Number: 3475920-5Report Type:Expedited (15-DaCompany Report #JACGBR2000000137 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epistaxis Foreign Risperdal Initial or Prolonged Thrombocytopenia Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAY(S), ORAL Venlafaxine (Venlafaxine) SS ORAL 37.5 MG, 2 IN 1 DAY(S), ORAL Co-Danthramer (Dorbanex) SS ORAL ML, DAILY, ORAL Thyroxine (Levothyroxine Sodium) C Lisinopril (Lisinopril) C Gliclazide (Gliclazide) C Calcichew (Calcium Carbonate) C Date:03/15/00ISR Number: 3476223-5Report Type:Expedited (15-DaCompany Report #A006008 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Weight Increased Consumer Navane Capsules PS ORAL ORAL Initial or Prolonged Risperidone SS Required Intervention to Prevent Permanent Impairment/Damage Date:03/15/00ISR Number: 3476228-4Report Type:Expedited (15-DaCompany Report #JACGER2000000290 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Psychosis Foreign Risperdal (Tablet) Initial or Prolonged Consumer (Risperidone) PS ORAL ORAL Date:03/15/00ISR Number: 3476289-2Report Type:Direct Company Report # Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Risperdal PS 2MG HS;4MG HS Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:20 AM Page: 763 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/00ISR Number: 3477149-3Report Type:Expedited (15-DaCompany Report #A008674 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoglycaemia Health Glucotrol Tablets PS ORAL ORAL Initial or Prolonged Suicide Attempt Professional Risperdal SS ORAL ORAL Date:03/17/00ISR Number: 3477405-9Report Type:Expedited (15-DaCompany Report #USA/00/00442/LEX Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Health Clozaril (Clozapine) PS ORAL 350 MG, Hospitalization - Diabetes Mellitus Professional OTHER, ORAL 1 YR Initial or Prolonged Insulin-Dependent Risperdal Required Hyperglycaemia (Risperidone) SS Intervention to Psychotic Disorder Reglan Prevent Permanent (Metoclopramide) C Impairment/Damage Vitamin B6 (Pyridoxine Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Isoniazid C Date:03/20/00ISR Number: 3478337-2Report Type:Expedited (15-DaCompany Report #JRFBEL2000000546 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperidone (Tablet) Initial or Prolonged Petechiae Health (Risperidone) PS ORAL MG, DAILY, Psychotic Disorder Professional ORAL Thrombocytopenia Bromperidol (Unspecified) (Bromperidol) C Promethazine Hydrochloride (Promethazine Hydrochloride) C Date:03/20/00ISR Number: 3478338-4Report Type:Expedited (15-DaCompany Report #JACFRA2000000135 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal (1mg Initial or Prolonged Health Tablet) Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Fragmin (Heparin-Fraction, Sodium Salt) C Diantalvic (Diantalvic) C Augmentin (Clavulin) C Athymil (Mianserin Hydrochloride) C Kardegic (Acetylsalicylate Lysine) C Atrovent 22-Feb-2006 08:20 AM Page: 764 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Ipratropium Bromide) C Solucort (Prednisolone) C Oropivalone (Oropivalone) C Didronel (Etidronate Disodium) C Cordipatch 9clyceryl Trinitrate) C Kaleorid (Potassium Chloride) C Imovane (Zopiclone) C Dafalgan (Paracetamol) C Discotrine (Glyceryl Trinitrate) C Date:03/20/00ISR Number: 3478339-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000001777 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Risperdal (0.5 Mg Initial or Prolonged Asthenia Tablet) Required Blood Creatinine (Risperidone) PS ORAL 0.5 MG, 1 IN Intervention to Increased 1 DAY(S), Prevent Permanent Blood Potassium Increased ORAL Impairment/Damage Condition Aggravated Dehydration Difficulty In Walking Haematuria Haemorrhage Insomnia Nausea Pneumonia Red Blood Cell Count Increased Renal Failure Acute White Blood Cell Count Increased Date:03/20/00ISR Number: 3478340-2Report Type:Expedited (15-DaCompany Report #JACGER2000000297 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amenorrhoea Foreign Risperdal (Tablet) Initial or Prolonged Breast Cancer Female Health (Risperidone) PS ORAL MG, DAILY, Required Hyperprolactinaemia Professional ORAL Intervention to Risperdal (Tablet) Prevent Permanent (Risperidone) SS ORAL MG, DAILY, Impairment/Damage ORAL Date:03/20/00ISR Number: 3478341-4Report Type:Expedited (15-DaCompany Report #JRFUSA2000001750 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 765 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cogentin (Benzatropine Mesilate) C Date:03/22/00ISR Number: 3478994-0Report Type:Expedited (15-DaCompany Report #JACFRA2000000136 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Attention Foreign Haldol (5 Mg/Ml Hospitalization - Deficit/Hyperactivity Health Injection) Initial or Prolonged Disorder Professional (Haloperidol) PS INTRAMUSCULAR INJECT Blood Creatine Company Haldol Faible (0.5 Phosphokinase Increased Representative Mg/Ml Solution) Cardiac Arrest (Haloperidol) SS ORAL 15 DROP, 2 IN Coma 1 DAY(S), Electrolyte Imbalance ORAL Enzyme Abnormality Risperdal (1 Mg Gastrointestinal Tablet) Haemorrhage (Risperidone) SS ORAL 1 MG, 1 IN 1 Haemoglobin Decreased DAY(S), ORAL Hypoxia Tiapridal (Tiapride) SS ORAL ORAL Infection Tranxene Labile Blood Pressure (Clorazepate Pyrexia Dipotassium) C Staphylococcal Infection Depakine (Valproate Thrombocytopenia Sodium) C Date:03/23/00ISR Number: 3479006-5Report Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Risperdal PS ORAL 1 MG PO HS Eye Movement Disorder Nausea Trismus Date:03/23/00ISR Number: 3479378-1Report Type:Expedited (15-DaCompany Report #JRFBEL2000000284 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Level Above Foreign Risperdal (Tablet) Therapeutic Health (Risperidone) PS ORAL MG, DAILY, Neutropenia Professional ORAL Thrombocytopenia Valproate Sodium (Valproate Sodium) SS ORAL MG, DAILY, ORAL Date:03/23/00ISR Number: 3479379-3Report Type:Expedited (15-DaCompany Report #JACFRA2000000136 Age:20 YR Gender:Male I/FU:I Outcome PT Life-Threatening Attention Hospitalization - Deficit/Hyperactivity Initial or Prolonged Disorder Blood Creatine Phosphokinase Increased Blood Electrolytes 22-Feb-2006 08:20 AM Page: 766 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Cardiac Arrest Coma Enzyme Abnormality Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Foreign Risperdal (1 Mg Gastrointestinal Health Tablet) Haemorrhage Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 Hypoxia Company DAY (S), ORAL Infection Representative Haldol (5 Mg/Ml Labile Blood Pressure Injection) Pyrexia (Haloperidol) SS INJECT Staphylococcal Infection Haldol Faible (0.5 Thrombocytopenia Mg/Ml Solution) (Haloperidol) SS ORAL 15 DROPS, 2 IN 1 DAY (S), ORAL Tiapridal (Tiapride) SS ORAL ORAL Tranxene (Clorazepate Dipotassium) C Depakine (Valproate Sodium) C Date:03/23/00ISR Number: 3479380-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000000603 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Foreign Risperidone (Tablet) Conjunctivitis Health (Risperidone) PS ORAL MG, DAILY, Glaucoma Professional ORAL Keratitis Ecolicin (Ecolicin) C Ocular Hyperaemia Biperiden (Hydrochloride (Biperiden Hydrochloride) C Date:03/24/00ISR Number: 3480106-4Report Type:Expedited (15-DaCompany Report #2000UW00926 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Creatine Health Seroquel "Zeneca" PS Zeneca ORAL 600 MG QD PO Phosphokinase Increased Professional Seroquel "Zeneca" SS Zeneca ORAL 400 MG BID PO Conjunctivitis Risperdal SS ORAL 1 MG BID PO Dehydration Risperdal SS ORAL 3 MG QD PO Drug Toxicity Risperdal SS ORAL 4 MG QD PO Leukopenia Loxitane SS Mental Impairment Lithium SS Muscle Rigidity Synthroid C Neuroleptic Malignant Depakote C Syndrome Pyrexia Date:03/24/00ISR Number: 3480310-5Report Type:Expedited (15-DaCompany Report #JRFUSA2000001786 Age:69 YR Gender:Male I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:20 AM Page: 767 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Atrioventricular Block Health Risperdal (Tablet) Complete Professional (Risperidone) PS ORAL 0.75 MG, Overdose DAILY, ORAL Thorazine (Chlorpromazine Hydrochloride) C Date:03/24/00ISR Number: 3480311-7Report Type:Expedited (15-DaCompany Report #JAAUS27806 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hydronephrosis Foreign Risperidone (Tablet) Health (Risperidone) PS ORAL 8 MG, DAILY, Professional ORAL, 6 MG, DAILY, ORAL Date:03/24/00ISR Number: 3480312-9Report Type:Expedited (15-DaCompany Report #JRFBEL2000000398 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bradycardia Foreign Risperidone (Tablet) Cardiac Output Decreased Health (Risperidone) PS ORAL MG, DAILY, Condition Aggravated Professional ORAL Dizziness Lithium Carbonate Drug Interaction (Lithium Carbonate) SS ORAL MG, DAILY, Hypotension ORAL Kleptomania Fluvoxamine Maleate Nausea (Fluvoxamine Sick Sinus Syndrome Maleate) SS ORAL MG, DAILY, ORAL Magnesium Oxide (Magnesium Oxide) C Date:03/24/00ISR Number: 3480687-0Report Type:Expedited (15-DaCompany Report #JRFUSA2000002006 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Risperdal (Tablet) Initial or Prolonged Leukopenia Professional (Ridperidone) PS ORAL 4 MG, DAILY, Required Neutropenia ORAL Intervention to Pyrexia Prevent Permanent Impairment/Damage Date:03/24/00ISR Number: 3480691-2Report Type:Expedited (15-DaCompany Report #JRFUSA2000002001 Age:51 YR Gender:Female I/FU:I Outcome PT Hospitalization - Delirium Initial or Prolonged Hyponatraemia Required Leukocytosis Intervention to Lower Limb Fracture Prevent Permanent Pneumonia Aspiration Impairment/Damage Respiratory Distress 22-Feb-2006 08:20 AM Page: 768 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Failure Report Source Product Role Manufacturer Route Dose Duration Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Clozapine (Clozapine) SS ORAL ORAL Seroquel (Seroquel) SS ORAL ORAL Date:03/24/00ISR Number: 3480711-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000000546 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Foreign Risperidone (Tablet) Initial or Prolonged Thrombocytopenic Purpura Health (Risperidone) PS ORAL MG, DAILY, Required Mouth Haemorrhage Professional ORAL 5 YR Intervention to Petechiae Bromperidol Prevent Permanent Psychotic Disorder (Unspecified) Impairment/Damage Thrombocytopenia (Bromperidol) SS ORAL MG, DAILY, ORAL 5 YR Promethazine Hydrochloride (Promethazine Hydrochloride) SS ORAL MG, DAILY, ORAL 5 YR Date:03/24/00ISR Number: 3544519-4Report Type:Periodic Company Report #USA011996 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Consumer Meridia PS Knoll Pharmaceutical Co Sub Basf Corp ORAL 15 MG OD PO Xanax SS ORAL 0.05 MG OD PO Risperdal SS ORAL 1 MG BID PO Risperdal SS ORAL 1 MG NOCTE PO Celebrex SS ORAL 200 MG OD PO Wellbutrin C Prilosec C Folic Acid C Ecotrin C Vitamin E C Date:03/27/00ISR Number: 3480500-1Report Type:Expedited (15-DaCompany Report #JAUSA36761 Age:47 YR Gender:Male I/FU:F Outcome PT Hospitalization - Asthenia Initial or Prolonged Cataract Chest Discomfort Condition Aggravated Depression Disturbance In Attention Face Oedema Intraocular Pressure Increased Pain Photosensitivity Reaction Psychotic Disorder 22-Feb-2006 08:20 AM Page: 769 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vision Blurred Visual Acuity Reduced Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal (4 Mg Tablet) (Risperidone) PS ORAL 4 MG, 2 IN 1 DAY (S), ORAL Seroquel (Seroquel) SS ORAL 100 MG; 300 MG, 3 IN 1 DAY (S), ORAL .. C Artane (Trihexyphenidyl) C Paxil (Paroxetine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:03/27/00ISR Number: 3480501-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000000603 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Foreign Risperidone (Tablet) Conjunctivitis Health (Risperidone) PS ORAL MG, DAILY, Drug Interaction Professional ORAL Glaucoma Biperiden Keratitis Hydrochloride Ocular Hyperaemia (Biperiden Visual Disturbance Hydrochloride) SS ORAL MG, DAILY, ORAL Ecolicin (Ecolicin) C Date:03/27/00ISR Number: 3480544-XReport Type:Expedited (15-DaCompany Report #JRFUSA1999001672 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Consumer Risperdal (1 Mg Hospitalization - Diarrhoea Tablet) Initial or Prolonged Drooling (Risperidone) PS ORAL 1 MG, 1 IN 1 Hallucinations, Mixed DAY(S), ORAL Nausea (SEE IMAGE) Urinary Incontinence Tylenol (Paracetamol) C Claritin (Loratadine) C Date:03/27/00ISR Number: 3480546-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000002023 Age:52 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Convulsion Required Electrocardiogram Intervention to Abnormal Prevent Permanent Grand Mal Convulsion Impairment/Damage Heart Rate Increased Hypochloraemia 22-Feb-2006 08:20 AM Page: 770 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypokalaemia Hyponatraemia Pyrexia Report Source Product Role Manufacturer Route Dose Duration Vomiting Health Risperdal (4 Mg Professional Tablet) (Risperidone) PS ORAL 4 MG, DAILY, ORAL Prolixin (Fluphenazine Hydrochloride) C Symmetrel (Amantadine Hydrochloride) C Clonazepam (Clonazepam) C Date:03/27/00ISR Number: 3480550-5Report Type:Expedited (15-DaCompany Report #JRFUSA2000001956 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bleeding Time Prolonged Consumer Risperdal (1 Mg Laboratory Test Abnormal Tablet) (Risperidone) PS ORAL 1 MG, 4 IN 1 DAY(S), ORAL Clonidine (Clonidine) C Paxil (Paroxetine Hydrochloride) C Neurontin (Gabapentin) C Date:03/29/00ISR Number: 3481528-8Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Androgen Insensitivity Consumer Risperdal 2mg Disability Syndrome Tablets PS 1 TABLET TWIC Required 1 TABLET EVER Intervention to Prevent Permanent Impairment/Damage Date:03/30/00ISR Number: 3481868-2Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Health Risperidone PS 1 MG AM/ 2 MG Required Muscle Rigidity Professional HS Intervention to Tremor Multivitamin C Prevent Permanent Calcium C Impairment/Damage Acetaminophen C Benzatropine C Levothyroxine C Lithium C Trazodone C Divalproex (Valproate) C Omeprazole C 22-Feb-2006 08:20 AM Page: 771 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Timisatin C Ciprofloxacin C Heparin C Roxicet C Date:03/30/00ISR Number: 3482042-6Report Type:Expedited (15-DaCompany Report #JACGER2000000380 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Foreign Risperdal (Tablet) Initial or Prolonged Dysphagia Health (Risperidone) PS ORAL MG, DAILY, Required Feeding Disorder Professional ORAL Intervention to Haemoglobin Decreased Eunerpan (Melperone Prevent Permanent Leukopenia Hydrochloride) C Impairment/Damage Parkinsonism Tremor Date:03/30/00ISR Number: 3482046-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000002213 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cyanosis Health Risperdal (2 Mg Loss Of Consciousness Professional Tablet) Myocardial Infarction (Risperidone) PS ORAL 2 MG, 1 IN 1 DAY(S), ORAL; 4 MG, 1 IN 1 NIGHT(S) ORAL Celexa (Citalopram Hydrobromide) C Vicoprofen (Vicoprofen) C Wellbutrin (Amfebutamone Hydrchloride) C Flexeril (Cyclobenzaprine Hydrochloride) C Date:03/30/00ISR Number: 3482052-9Report Type:Expedited (15-DaCompany Report #JRFBEL2000000879 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Lower Foreign Risperidone (Tablet) Ileus Paralytic Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Nitrazepam (Nitrazepam) C Date:03/30/00ISR Number: 3482054-2Report Type:Expedited (15-DaCompany Report #JAOCAN2000000202 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Consumer (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 772 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/30/00ISR Number: 3482056-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000002248 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Carbamazepine (Carbamazepine) SS Doxepin (Doxepin) SS Fluoxetine (Fluoxetine) SS Cocaine (Cocaine) SS Date:03/31/00ISR Number: 3482508-9Report Type:Expedited (15-DaCompany Report #JACFRA2000000136 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Attention Foreign Risperdal Hospitalization - Deficit/Hyperactivity Health (Risperidone) PS ORAL 1 MG, 1 IN 1 Initial or Prolonged Disorder Professional DAY(S), ORAL Bacterial Infection Company Haldol Blood Creatine Representative (Haloperidol) SS INJECT Phosphokinase Increased Haldol Faible Blood Electrolytes (Haloperidol) SS ORAL 15 DROP, 2 IN Abnormal 1 DAY(S), Cardiac Arrest ORAL Coma Tiapridal (Tiapride) SS ORAL ORAL Enzyme Abnormality Tranxene Extrapyramidal Disorder (Clorazepate Gastrointestinal Dipotassium) C Haemorrhage Depakine (Valproate Hypoxia Sodium) C Labile Blood Pressure Liver Function Test Abnormal Lung Disorder Muscle Disorder Pyrexia Skin Infection Staphylococcal Infection Thrombocytopenia Date:03/31/00ISR Number: 3482512-0Report Type:Expedited (15-DaCompany Report #JAUK23074 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Risperdal PS ORAL 3 MG, 1 IN 1 Agitation Health DAY(S), ORAL Blood Creatine Professional Droleptan Phosphokinase Increased (Unspecified)(Droper Cardiac Arrest idol) C Coma Diazepam (Diazepam) C Coordination Abnormal Procyclidine Emotional Distress (Tablet) Neuroleptic Malignant (Trocyclidine) C Syndrome Carbamazepine(Carbam azepine) C 22-Feb-2006 08:20 AM Page: 773 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/31/00ISR Number: 3482514-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000000357 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deafness Foreign Risperdal Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Date:03/31/00ISR Number: 3482518-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000002244 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Risperdal (1 Mg Initial or Prolonged Pulmonary Oedema Professional Tablet) Respiratory Distress (Risperidone) PS ORAL 1 MG, 2 IN 1 Ventricular Extrasystoles DAY(S), ORAL Date:03/31/00ISR Number: 3482520-XReport Type:Expedited (15-DaCompany Report #JRFUSA2000002076 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Health Risperdal (Tablet) Thrombocytopenia Professional (Risperidone) PS ORAL 1.5 MG, 1 IN 1 NIGHT(S), ORAL Date:03/31/00ISR Number: 3482523-5Report Type:Expedited (15-DaCompany Report #JACGER2000000374 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adams-Stokes Syndrome Foreign Risperdal Initial or Prolonged Electrocardiogram Qt Health (Risperidone) PS ORAL MG, DAILY, Prolonged Professional ORAL Cardiac Therapy C Date:03/31/00ISR Number: 3482525-9Report Type:Expedited (15-DaCompany Report #JRFUSA2000002246 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS ORAL ORAL Professional Date:04/04/00ISR Number: 3483590-5Report Type:Direct Company Report # Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Risperdal 1 T0 4 Mg Intervention to Phosphokinase Abnormal Janssen PS Janssen ORAL 1 TO 4 MG Prevent Permanent Hypertension DAILY ORAL Impairment/Damage Neuroleptic Malignant Lorazepam C Syndrome Influenza Virus Pyrexia Vaccine C Tachycardia 22-Feb-2006 08:20 AM Page: 774 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/00ISR Number: 3484185-XReport Type:Expedited (15-DaCompany Report #FLUV00300001630 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Fluvoxamine Initial or Prolonged First Degree Literature (Fluvoxamine) PS 100 DAILY Bundle Branch Block Other UNK, 150 MG Bilateral DAILY UNK, 50 Constipation MG DAILY UNK Dizziness Haloperidol Drug Interaction (Haloperidol) SS UNK DAILY UNK Extrapyramidal Disorder Risperidone Fatigue (Risperidone) SS ORAL 2 MG DAILY Intentional Overdose UNK, 4 MG Joint Stiffness DAILY UNK, 2 Nausea MG DAILY UNK, Orthostatic Hypotension 24 MG DAILY Paranoia Sinus Tachycardia Suicide Attempt Syncope Thinking Abnormal Date:04/04/00ISR Number: 3484216-7Report Type:Expedited (15-DaCompany Report #JRFBEL2000000646 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Haloperidol Completed Suicide Health (Unspecified) Condition Aggravated Professional (Haloperidol) PS ORAL MG, DAILY, Hallucination ORAL Overdose Risperidone (Tablet) Persecutory Delusion (Risperidone) SS ORAL MG, DAILY, ORAL Perphenazine Fendizoate (Perphenazine) SS ORAL MG, DAILY, ORAL Fluphenazine Maleate (Fluphenazine Maleste) C Clonazepam (Clonazepam) C Trihexyphenidyl Hydrcholoride (Trihexyphenidyl Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Flunitrazepam (Flunitrazepam) C Zopiclone (Zopiclone) C Vegetamin A (Vegetamin A) C 22-Feb-2006 08:20 AM Page: 775 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/00ISR Number: 3484454-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000000200 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Risperdal (1 Mg Initial or Prolonged Phosphokinase Increased Professional Tablet) Conjunctivitis (Risperidone) PS ORAL SEE IMAGE Dehydration Seroquel (Seroquel) SS ORAL SEE IMAGE Diabetes Mellitus Loxitane (Loxitane Drug Level Above Succinate) SS ORAL SEE IMAGE Therapeutic Lithium (Lithium) SS ORAL SEE IMAGE Drug Toxicity Depakote (Valproate Hypertension Semisodium) SS ORAL SEE IMAGE Lethargy Fiber Lax Leukopenia (Polycarbophl Mental Impairment Calcium) C Muscle Rigidity Synthroid Neuroleptic Malignant (Levothyroxine Syndrome Sodium) C Neutropenia Trazodone Polyuria (Trazodone) C Pyrexia Cogentin Tachycardia (Benzatropine Tremor Mesilate) C Colace (Docusate Sodium) C Ddavrp (Desmopressin) C Zoloft (Sertraline Hydrochloride) C Lactaid (Tilactase) C Erythromycin (Erythromycin) C Lac-Hydrin (Ammonium Lactate) C Date:04/06/00ISR Number: 3484838-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000000398 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bradycardia Foreign Risperidone (Tablet) Cardiac Disorder Health (Risperidone) PS ORAL MG, DAILY, Condition Aggravated Professional ORAL Dizziness Lithium Carbonate Drug Interaction (Lithium Carbonate) SS ORAL MG, Hypotension DAILY,ORAL Kleptomania Fluvoxamine Maleate Nausea (Fluvoxamine Sick Sinus Syndrome Maleate) SS ORAL MG, DAILY,ORAL Magnesium Oxide (Magnesium Oxide) C Date:04/06/00ISR Number: 3484841-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000000344 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Polycythaemia Vera Study Risperdal Health (Risperidone) PS ORAL 8 MG, DAILY, Professional ORAL 22-Feb-2006 08:20 AM Page: 776 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haldol (Unspecified) (Haloperidol) SS ORAL 14 MG, DAILY, ORAL Olanzapine (Olanzapine) SS ORAL 17.5 MG, DAILY, ORAL Atenolol (Atenolol) C Clonazepam (Clonazepam) C Cogentin (Benzatropine Mesilate) C Atenolol (Atenolol) C Clonazepam (Clonazepam) C Cogentin (Benzatropine Mesilate) C Date:04/06/00ISR Number: 3484842-5Report Type:Expedited (15-DaCompany Report #JAOCAN2000000202 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Depressed Level Of Foreign Risperdal Consciousness Consumer (Risperidone) PS ORAL ORAL Dyspnoea Company Representative Date:04/06/00ISR Number: 3484843-7Report Type:Expedited (15-DaCompany Report #JAUK32453 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Depixol (Flupentixol) C Benztropine (Benztropine) C Date:04/06/00ISR Number: 3484845-0Report Type:Expedited (15-DaCompany Report #JRFUSA2000002286 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Breast Cancer Female Health Risperdal (2 Mg Intervention to Mastectomy Professional Tablet) Prevent Permanent (Risperidone) PS ORAL 2 MG, 1 IN 1 Impairment/Damage DAY(S), ORAL Date:04/06/00ISR Number: 3484847-4Report Type:Expedited (15-DaCompany Report #JACFRA200000231 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Death Pulmonary Embolism Foreign Health Professional Company 22-Feb-2006 08:20 AM Page: 777 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Risperdal (Tablet) (Risperidone) PS ORAL MG, DAILY, ORAL Tercian (Cyamemazine) SS ORAL ORAL Date:04/06/00ISR Number: 3484892-9Report Type:Direct Company Report # Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delirium Health Risperdal 4mg Sedation Professional Janssen PS Janssen 4MG QHS 1 WK Verapamil Sr 240mg Udl SS Udl SR 240 QD 1 WK Meclizine 25 Mg SS Udl 75 MG BID @ WEEK Klonopin 1 Mg SS 1 MG TID @ WEEK Date:04/07/00ISR Number: 3485276-XReport Type:Expedited (15-DaCompany Report #20000300816 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Foreign Atacand PS ORAL PO Initial or Prolonged Face Oedema Study Risperdal SS Sedation Health Risperdal SS Professional Trazodone Hydrochloride C Date:04/07/00ISR Number: 3485367-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000002365 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Consumer Risperdal Initial or Prolonged Constipation (Risperidone) PS ORAL ORAL Intentional Overdose Effexor (Venlafaxine Oedema Hydrochloride) C Suicide Attempt Weight Increased Date:04/10/00ISR Number: 3485958-XReport Type:Expedited (15-DaCompany Report #WAES 00033001 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Tab Vioxx PS ORAL PO Initial or Prolonged Aphasia Risperdal SS Condition Aggravated Celebrex C Decreased Activity Zoloft C Dementia Alzheimer'S Type Captopril C Haematochezia Furosemide C Haemoglobin Decreased Metoprolol Succinate C Hallucination Omeprazole C Lethargy Quinine Sulfate C Rectal Haemorrhage 22-Feb-2006 08:20 AM Page: 778 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/10/00ISR Number: 3486479-0Report Type:Expedited (15-DaCompany Report #WAES 00033001 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Tab Vioxx PS ORAL PO Initial or Prolonged Condition Aggravated Risperdal SS Dementia Alzheimer'S Type Celebrex C Haematochezia Zoloft C Hallucination Captopril C Lethargy Furosemide C Oral Intake Reduced Metoprolol Succinate C Poverty Of Speech Omeprazole C Rectal Haemorrhage Quinine Sulfate C Date:04/11/00ISR Number: 3486855-6Report Type:Expedited (15-DaCompany Report #HQ2128506APR2000 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Efexor (Venlafaxine Initial or Prolonged Hyponatraemia Health Hydrochloride) PS ORAL 150 MG 1X PER Other Professional 1 DAY ORAL Other Risperidone SS ORAL 2.5MG 1XPER 1 DAY Co-Dydramol C Lactulose C Date:04/12/00ISR Number: 3487547-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000000913 Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Risperdal (1 Mg Initial or Prolonged Dizziness Health Tablet) Hemiparesis Professional (Risperidone) PS ORAL MG, DAILY, ORAL Selen E-Vitamin (Selen Med Naturligt E-Vitamin) C Nitromex (Glyceryl Trinitrate) C Renitec (Enalapril Maleate) C Trombyl (Acetylsalicylic Acid) C Date:04/12/00ISR Number: 3487549-3Report Type:Expedited (15-DaCompany Report #JAOCAN2000000087 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cough Foreign Risperdal Hospitalization - Dysphagia Health (Unspecified ) Initial or Prolonged Pneumonia Aspiration Professional (Risperidone) PS ORAL 3 MG, DAILY, Required Respiratory Failure Company ORAL Intervention to Representative Prevent Permanent Impairment/Damage 22-Feb-2006 08:20 AM Page: 779 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/00ISR Number: 3487553-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000000765 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Foreign Risperidone (Tablet) Hospitalization - Cyanosis Health (Risperidone) PS ORAL MG, DAILY, Initial or Prolonged Depressed Level Of Professional ORAL Consciousness Haldol (Unspecified) Dysarthria (Haloperidol) C Eye Rolling Promethazine Fall Hydrochloride Grand Mal Convulsion (Promethazine Respiratory Disorder Hydrochloride) C Sedation Pantethine Sleep Disorder (Pantethine) C Snoring Teprenone Speech Disorder (Teprenone) C Protoporphyrin Disodium (Protoporphyrin Disodium) C Clinofibrate (Cliofibrate) C Vegetamin-B (Vegetamin B (R) ) C Flunitrazepam (Flunitrazepam) C Nitrazepam (Nitrazepam) C Sennoside (Sennosides) C Date:04/12/00ISR Number: 3487557-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999002000 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Risperidone (Tablet) Required Phosphokinase Increased Health (Risperidone) PS ORAL MG, TABLET, Intervention to Hypokalaemia Professional ORAL Prevent Permanent Hyponatraemia Haloperidol (Tablet) Impairment/Damage Inappropriate (Haloperidol) SS ORAL MG, DAILY, Antidiuretic Hormone ORAL Secretion Levomepromazine Muscle Rigidity Maleate Neuroleptic Malignant (Levomepromazine Syndrome Maleate) C Polydipsia Polyuria Pyrexia Tremor Water Intoxication Date:04/12/00ISR Number: 3487589-4Report Type:Expedited (15-DaCompany Report #JRFUSA2000000591 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Differential White Blood Health Risperdal (Tablet) Initial or Prolonged Cell Count Abnormal Professional (Risperdone) PS ORAL 2 MG, 2 IN 1 Leukopenia DAY(S); 1 MG, Neutropenia 2 IN 1 22-Feb-2006 08:20 AM Page: 780 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY(S), ORAL Imipramine (Imipramine) C Multivit (Multivit) C Date:04/12/00ISR Number: 3487591-2Report Type:Expedited (15-DaCompany Report #JRFBEL2000000484 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Risperdal (1 Mg Initial or Prolonged Hyponatraemia Health Tablet) (Rispridone) PS ORAL ORAL; 2 MG, 2 Polydipsia Professional IN 1 DAY(S), Water Intoxication ORAL Sodium Valproate (Valproate Sodium) SS ORAL MG, DAILY, ORAL Thyroxin (Levothyroxine Sodium) C Date:04/12/00ISR Number: 3487593-6Report Type:Expedited (15-DaCompany Report #JRFBEL2000000546 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperidone (Tablet) Initial or Prolonged Idiopathic Health (Risperidone) PS ORAL MG, DAILY, Required Thrombocytopenic Purpura Professional ORAL 5 YR Intervention to Mouth Haemorrhage Bromperidol Prevent Permanent Petechiae (Unspecified) Impairment/Damage Psychotic Disorder (Bromperidol) SS ORAL MG, DAILY, Thrombocytopenia ORAL 5 YR Viral Infection Promethazine Hydrochloride ( Promethazine Hydrochloride) SS ORAL MG, DAILY, ORAL 5 YR Promethazine Hydrochloride (Premethazine Hydrochloride) SS Date:04/13/00ISR Number: 3488089-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000000991 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amyotrophic Lateral Foreign Risperdal Sclerosis Health (Unspecified) Professional (Risperidone) PS Date:04/13/00ISR Number: 3488092-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000000907 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Foreign Risperdal (1 Mg Initial or Prolonged Cerebrovascular Disorder Health Tablet) Condition Aggravated Professional (Risperidone) PS ORAL ORAL Dizziness Alvedon Hemiparesis (Paracetamol) C 22-Feb-2006 08:20 AM Page: 781 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Propavan (Propiomazine Maleate) C Esucos (Dixyrazine) C Importal (Lactitol) C Efexor (Venlafaxine Hydrochloride) C Asasantin Retard (Asasantin) C Losec (Omeprazole) C Date:04/17/00ISR Number: 3488876-6Report Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dyspnoea Resperidol 4mg PS Q DINNER Muscle Rigidity Prozac C Tongue Disorder Tongue Oedema Date:04/17/00ISR Number: 3489025-0Report Type:Expedited (15-DaCompany Report #JAOCAN1999000488 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetes Mellitus Foreign Risperdal (Tablet) Dyskinesia Health (Risperidone) PS ORAL SEE IMAGE Parkinson'S Disease Professional Glyburide Polydipsia Company (Glibenclamide) SS Polyuria Representative Luvox C Tremor Epival C Lamictal C Date:04/17/00ISR Number: 3489109-7Report Type:Expedited (15-DaCompany Report #00-02-0070 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Clozapine - Zenith Initial or Prolonged Convulsion Professional Goldline Pharm. Delirium Tablets PS Zenith Goldline Hyponatraemia Pharm. ORAL 125MG ORAL Leukocytosis Seroquel Tablets SS ORAL ORAL Lower Limb Fracture Risperdal Tablets SS ORAL ORAL Oxygen Saturation Prozac C Decreased Pneumonia Aspiration Psychotic Disorder Respiratory Distress Respiratory Failure Respiratory Rate Increased Date:04/17/00ISR Number: 3551712-3Report Type:Periodic Company Report #JRFUSA2000000804 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthma Health Propulsid PS Janssen Research Fdn Professional Div Johnson And 22-Feb-2006 08:20 AM Page: 782 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Johnson ORAL 10 MG, 3 IN 1 DAY (S), ORAL Risperdal (Unspecified) (Risperidone) SS ORAL 0.5 MG 1 IN 1 DAY (S), ORAL Vitamin (Multiple Vitamins) C Co-Enzymes Q10 (Ubidecarenone) C Valium (Diazepam) C Flovent (Fluticasone Propionate) C Mellaril (Thiotidazine Hydrochloride) C Inderal (Propranolol Hydrochloride) C Prevacid (Lansoprazole) C Date:04/19/00ISR Number: 3490179-0Report Type:Direct Company Report # Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Health Risperidone PS UNK Hospitalization - Prolonged Professional Clindamycin C Initial or Prolonged Heart Rate Decreased Levofloxacin C Required Ambien C Intervention to Phenytoin C Prevent Permanent Aspirin C Impairment/Damage Date:04/19/00ISR Number: 3490200-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000000603 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blindness Foreign Risperidone (Tablet) Blood Cholesterol Health (Risperidone) PS ORAL MG, DAILY, Increased Professional ORAL Conjunctivitis Biperiden Drug Interaction Hydrochloride Glaucoma (Biperiden Intraocular Pressure Hydrochloride) SS ORAL MG, DAILY, Increased ORAL Keratitis Ecolicin (Ecolicin) C Keratopathy Ocular Hyperaemia Protein Total Increased Visual Acuity Reduced Visual Disturbance Date:04/19/00ISR Number: 3490201-1Report Type:Expedited (15-DaCompany Report #JRFBEL2000000097 Age:70 YR Gender:Female I/FU:F Outcome PT Death Circulatory Collapse Hospitalization - Hyponatraemia Initial or Prolonged Liver Function Test 22-Feb-2006 08:20 AM Page: 783 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL MG, DAILY, ORAL Orphenadrine Citrate (Orphenadrine Citrate) SS ORAL ORAL Latanoprost (Latanoprost) C Frusemide (Furosemide) C Roxithromycin (Roxithromycin) C Date:04/19/00ISR Number: 3490202-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000000907 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Foreign Risperdal (1 Mg Initial or Prolonged Cerebrovascular Disorder Health Tablet) Condition Aggravated Professional (Risperidone) PS ORAL ORAL Dizziness Alvedon Hemiparesis (Paracetamol) C Propavan (Propiomazine Maleate) C Esucos (Dixyrazine) C Importal (Lactitol) C Efexor (Venlafaxine Hydrochloride) C Asasantin Retard (Asasantin) C Losec (Omeprazole) C Date:04/19/00ISR Number: 3490203-5Report Type:Expedited (15-DaCompany Report #JAFRA38773 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Foreign Risperdal (Tablet) Initial or Prolonged Bronchial Obstruction Literature (Risperidone) PS ORAL MG, DAILY, Bronchospasm Health ORAL Cough Professional Paroxetine Cyanosis (Paroxetine) C Dyspnoea Exertional Bromocriptine Neutrophilia (Bromocriptine) C Pyrexia Rales Date:04/19/00ISR Number: 3490207-2Report Type:Expedited (15-DaCompany Report #JAFRA38925 Age:33 YR Gender:Female I/FU:I Outcome PT Death Asthenia Hospitalization - Completed Suicide Initial or Prolonged Cough 22-Feb-2006 08:20 AM Page: 784 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyspnoea Face Oedema Neutrophilia Report Source Product Role Manufacturer Route Dose Duration Urticaria Foreign Risperdal (Tablet) Literature (Risperidone) PS ORAL ORAL Health Tercian Professional (Cyamemazine) C Lexomil (Bromazepam) C Hep-A-Myl (Heptaminol Hydrochloride) C Date:04/19/00ISR Number: 3490917-7Report Type:Expedited (15-DaCompany Report #JACFRA2000000255 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Foreign Risperdal Initial or Prolonged Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Company Representative Date:04/20/00ISR Number: 3490826-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000000546 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperidone (Tablet) Initial or Prolonged Drug Hypersensitivity Health (Risperidone) PS ORAL MG, DAILY, Required Idiopathic Professional ORAL 5 YR Intervention to Thrombocytopenic Purpura Impromen Prevent Permanent Mouth Haemorrhage (Unspecified) Impairment/Damage Nasopharyngitis (Bromperidol) SS ORAL MG, DAILY, Petechiae ORAL 5 YR Psychotic Disorder Promethazine Thrombocytopenia Hydrochloride (Promethazine Hydrochloride) SS ORAL MG, DAILY ORAL 5 YR Haldol (Haloperidol) C Chlorpromazine (Chlorpromazine) C Cinal (Cinal) C Sairei-To (Sairei-To) C Date:04/20/00ISR Number: 3490829-9Report Type:Expedited (15-DaCompany Report #JACGBR2000000232 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Hyponatraemia Health (Unspecified) Professional (Risperidone) PS ORAL MG DAILY, ORAL Venlafaxine (Venlafaxine) SS ORAL DAILY, ORAL Co-Dydramol (Paramol-118) C Lactulose 22-Feb-2006 08:20 AM Page: 785 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Lactulose) C Date:04/20/00ISR Number: 3490830-5Report Type:Expedited (15-DaCompany Report #JACGBR2000000231 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Peripheral Ischaemia Foreign Risperdal Initial or Prolonged Health (Risperidone) PS ORAL 1 MG, 1 IN 1 Professional DAY(S), ORAL Date:04/21/00ISR Number: 3491068-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000000868 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Risperidone (Tablet) Hospitalization - Phosphokinase Increased Health (Risperidone) PS ORAL MG. DAILY, Initial or Prolonged Constipation Professional ORAL Required Diarrhoea Despa C Intervention to Dry Mouth Sodium Picosulfate Prevent Permanent Face Oedema (Sodium Picosulfate) C Impairment/Damage Haematuria Nitrazepam Headache (Nitrazepam) C Hyperhidrosis Biperiden Ileus Paralytic Hydrochloride Muscle Rigidity (Biperiden Myocardial Ischaemia Hydrochloride) C Neuroleptic Malignant Syndrome Oedema Peripheral Skin Exfoliation Stomatitis Stupor Vomiting Date:04/21/00ISR Number: 3491069-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000001093 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laryngospasm Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS MG, DAILY Cipramil (Citalopram) SS Date:04/21/00ISR Number: 3491070-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000002664 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 6 MG, DAILY, ORAL Neurontin (Gabapentin) C Congentin (Benzatropine Mesilate) C Levothroid 22-Feb-2006 08:20 AM Page: 786 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Levothroxine Sodium) C Tenormin (Atenolol) C Albuterol (Salbutamol) C Date:04/21/00ISR Number: 3491115-3Report Type:Expedited (15-DaCompany Report #WAES 00040025 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Tab Vioxx Unk PS ORAL PO Initial or Prolonged Condition Aggravated Professional Risperdal Ukn SS 2 MG/HS Drug Interaction Depakote C Hallucination Clonazepam C Imprisonment Psychotic Disorder Date:04/21/00ISR Number: 3491145-1Report Type:Expedited (15-DaCompany Report #JRFBEL2000000879 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Lower Foreign Risperidone (Tablet) Initial or Prolonged Ileus Paralytic Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Nitrazepam (Nitrazepam) C Date:04/24/00ISR Number: 3491744-7Report Type:Expedited (15-DaCompany Report #JRFUSA2000002734 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 16 MG DAILY ORAL Date:04/24/00ISR Number: 3491746-0Report Type:Expedited (15-DaCompany Report #JRFBEL2000001048 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Decreased Foreign Risperidone Initial or Prolonged Medication Error Literature (Unspecified) Other Murder Health (Risperidone) PS ORAL 1 MG, 2 IN 1 Sedation Professional DAY(S) ORAL , Suicidal Ideation MG DAILY ORAL Sulpiride (Sulpiride) SS ORAL 200 MG , 2 IN 1 DAY(S) ORAL 3 MON Date:04/24/00ISR Number: 3491748-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000001095 Age:64 YR Gender:Female I/FU:I Outcome PT Death Coma Hospitalization - Condition Aggravated Initial or Prolonged Hepatic Failure Hepatotoxicity Multi-Organ Failure 22-Feb-2006 08:20 AM Page: 787 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychiatric Symptom Sepsis Stupor Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL MG , DAILY , ORAL Diazepam (Diazepam) C Lithium Carbonate (Lithium Carbonate) C Date:04/26/00ISR Number: 3493161-2Report Type:Expedited (15-DaCompany Report #HQ3778619APR2000 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Efexor (Venlafaxine Supraventricular Professional Hydrochloride) PS ORAL 1125 MG DAILY Supraventricular Other ORAL Tachycardia Risperidone Ventricular Arrhythmia (Risperidone) SS ORAL 0.5 MG 2X PER 1 DAY ORAL Date:04/28/00ISR Number: 3494019-5Report Type:Direct Company Report # Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Heart Rate Decreased Health Risperidone PS UNKNOWN UNK Professional Clindamycin C Levofloxacin C Ambien C Phenytoin C Aspirin C Date:04/28/00ISR Number: 3494315-1Report Type:Expedited (15-DaCompany Report #M0277-2000 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Remeron PS Abdominal Pain Upper Professional Risperdal SS Cholecystitis Other Paxil SS Gallbladder Disorder Liver Function Test Abnormal Date:04/28/00ISR Number: 3494362-XReport Type:Expedited (15-DaCompany Report #USA013488 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Meridia PS Initial or Prolonged Drug Ineffective Risperdal SS Drug Interaction Paxil SS Feeling Abnormal Prevacid C Hypothalamo-Pituitary Ativan C Disorders Pituitary Tumour Suicidal Ideation 22-Feb-2006 08:20 AM Page: 788 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/00ISR Number: 3494782-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000001096 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Risperidone (Tablet) Phosphokinase Increased Health (Risperidone) PS ORAL DAILY, ORAL Rhabdomyolysis Professional Vegetamin-B (Vegetamin B (R)) C Triazolam (Triazolam) C Zotepine (Zotepine) C Pravastatin Sodium (Pravastatin Sodium) C Cisapride (Cisapride) C Furosemide (Furosemide) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Quazepam (Quazepam) C Date:05/01/00ISR Number: 3495616-3Report Type:Expedited (15-DaCompany Report #JAOCAN1999000544 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Foreign Risperdal Hospitalization - Cardiac Failure Health (Unspecified) Initial or Prolonged Congestive Professional (Risperidone) PS ORAL ORAL (SEE Oedema IMAGE) Pulmonary Oedema Haldol C Largactil C Kemadrin C Ativan C Date:05/03/00ISR Number: 3495729-6Report Type:Direct Company Report # Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Health Risperidone / Initial or Prolonged Nausea Professional Risperdal 1mg PS ORAL 1 MG PO QHS Vomiting Date:05/03/00ISR Number: 3496743-7Report Type:Expedited (15-DaCompany Report #JRFBEL2000000646 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Haloperidol Completed Suicide Health (Unspecified) Dystonia Professional (Haloperidol) PS ORAL MG, DAILY, ORAL Risperidone (Tablet) (Risperidone) SS ORAL MG, DAILY, ORAL Perphenazine Fendizoate (Perphenazine) SS ORAL MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 789 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluphenazine Maleate (Fluphenazine Maleate) C Clonazepam (Clonazepam) C Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Flunitrazepam (Flunitrazepam) C Zopiclone (Zopiclone) C Vegetamin A (Vegetamin A) C Date:05/03/00ISR Number: 3496928-XReport Type:Expedited (15-DaCompany Report #J081-002-000377 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Aricept (Donepezil) PS ORAL 3 MG, 1 IN 1 Amnesia Health D, PER ORAL Blood Creatine Professional Risperdal Phosphokinase Increased (Risperidone) SS ORAL 1 MG X 2 Coma TABS, PER Facial Pain ORAL Hepatic Function Abnormal Vegetamin B Impulse-Control Disorder (Combination Drug) C Insomnia Tetramide (Mianserin Leukocytosis Hydrochloride) C Loss Of Consciousness Benzalin Neuroleptic Malignant (Nitrazepam) C Syndrome Date:05/04/00ISR Number: 3496658-4Report Type:Expedited (15-DaCompany Report #JRFUSA2000002933 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 3 MG, 2 IN 1 DAY(S), ORAL Clozaril (Clozapine) SS ORAL ORAL Risperdal (Tablet) (Risperidone) SS ORAL 2 MG, 2 IN 1 DAY(S), ORAL Haldol (Tablet) Haloperidol) C Date:05/04/00ISR Number: 3496782-6Report Type:Expedited (15-DaCompany Report #JRFBEL2000001095 Age:64 YR Gender:Female I/FU:F Outcome Death Hospitalization - 22-Feb-2006 08:20 AM Page: 790 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Coma Foreign Risperdal Condition Aggravated Health (Unspecified) Hepatic Failure Professional (Risperidone) PS Janssen Research Fdn Hepatotoxicity Div Johnson And Multi-Organ Failure Johnson ORAL MG, DAILY, Psychiatric Symptom ORAL Sepsis Diazepam (Diazepam) C Stupor Lithium Carbonate (Lithium Carbonate) C Date:05/05/00ISR Number: 3497054-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000002244 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Risperdal (1 Mg Initial or Prolonged Pulmonary Oedema Professional Tablet) Respiratory Distress (Risperidone) PS ORAL 1 MG, 2 IN 1 Ventricular Arrhythmia DAY (S), ORAL Ventricular Extrasystoles Date:05/05/00ISR Number: 3497055-8Report Type:Expedited (15-DaCompany Report #JACGBR2000000249 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arrhythmia Foreign Risperdal Supraventricular Health (Unspecified) Ventricular Arrhythmia Professional (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAY (S), ORAL Venlafaxine (Venlafaxine) SS ORAL MG, DAILY, ORAL Date:05/05/00ISR Number: 3497058-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000001141 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Duodenal Ulcer Foreign Risperdal (Tablet) Initial or Prolonged Perforation Health (Risperidone) PS ORAL MG, DAILY, Required Professional ORAL Intervention to Prevent Permanent Impairment/Damage Date:05/05/00ISR Number: 3497059-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000001096 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Foreign Risperidone (Tablet) Phosphokinase Increased Health (Risperidone) PS ORAL MG, DAILY, Neuroleptic Malignant Professional ORAL Syndrome Zotepine (Zotepine) SS ORAL MG, DAILY, Respiratory Failure ORAL Rhabdomyolysis Pravastatin Sodium 22-Feb-2006 08:20 AM Page: 791 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Pravastatin Sodium) SS ORAL MG, DAILY, ORAL Vegetamin-B (Vegetamin B (R) ) C Triazolam (Triazolam) C Cisapride (Unspecified) (Cisapride) C Fuosemide (Furosemide) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Quazepam (Quazepam) C Date:05/05/00ISR Number: 3497218-1Report Type:Expedited (15-DaCompany Report #00P-163-0089497-00 (0) Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Autonomic Nervous System Health Depakote (Depakote) Intervention to Imbalance Professional (Divalproex Sodium) PS ORAL 1500 MG, 1 IN Prevent Permanent Blood Creatine Other 1 D, PER ORAL Impairment/Damage Phosphokinase Increased (SEE IMAGE) Conjunctivitis Risperidone Dehydration (Risperidone) SS ORAL 1 MG, 2 IN 1 Diabetes Mellitus D, PER ORAL Drug Level Above (SEE IMAGE) Therapeutic Seroquel (Seroquel) SS ORAL 600 MG, 1 IN Drug Toxicity 1 D, PER ORAL Enuresis (SEE IMAGE) Feeling Abnormal Loxapine Succinate Hypertension (Loxapine Succinate) SS ORAL 10 MG, 1 IN 1 Lethargy D, PER ORAL Leukopenia (SEE IMAGE) Mental Impairment Lithium (Lithium) SS ORAL 300 MG, 2 IN Muscle Rigidity 1 D, PER ORAL Neuroleptic Malignant (SEE IMAGE) Syndrome Polycarbophil Neutropenia Calcium Pyrexia (Polycarbophil Tachycardia Calcium) C Tremor Levothyroxine Sodium (Levothyroxine Sodium) C Trazodone (Trazodone) C Benzatropine Mesilate (Benzatropine Mesilate) C Docusate Sodium (Docusate Sodium) C Desmopressin (Desmopressin) C Sertraline Hydrochloride (Sertraline Hydrochloride) C Tilactase 22-Feb-2006 08:20 AM Page: 792 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Tilactase) C Erythromycin (Erythromycin) (Erythromycin) C Ammonium Lactate (Ammonium Lactate) C Date:05/08/00ISR Number: 3497164-3Report Type:Direct Company Report # Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Risperidone PS ORAL 3 MG PO Initial or Prolonged Feeling Jittery Haldol SS PRN AT MHC Other Muscle Rigidity Benadryl SS ORAL 25 MG PO Neuroleptic Malignant Syndrome Pyrexia Speech Disorder Tachycardia Tremor Date:05/08/00ISR Number: 3497794-9Report Type:Direct Company Report # Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Risperdol 0.5mg Tab Initial or Prolonged Confusional State X 1 Or 4/12 (Started Post Procedural On 4/11/00) PS ORAL 0.5MG (PO) Complication Tylenol#3 (Acetaminophen #3) X 1 SS ORAL 30MG (PO) Date:05/08/00ISR Number: 3498217-6Report Type:Expedited (15-DaCompany Report #JACGER2000000243 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Haemolytic Foreign Risperdal Initial or Prolonged Autoimmune Health (Risperidone) PS ORAL MG DAILY Professional ORAL Zoloft (Sertraline Hydrochloride) SS ORAL ORAL Date:05/08/00ISR Number: 3498218-8Report Type:Expedited (15-DaCompany Report #JACGBR2000000063 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal (1 Mg Hospitalization - Dehydration Health Tablet) Initial or Prolonged Depressed Level Of Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 Other Consciousness Company DAY(S) , ORAL Renal Failure Representative Digoxin (Digoxin) C Aspirin (Acetylsalicylic Acid) C Lisinopril (Lisinopril) C Frusemide (Furosemide) C 22-Feb-2006 08:20 AM Page: 793 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amiloride (Amiloride) C Date:05/09/00ISR Number: 3497979-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Health Risperdal 1mg Intervention to Dystonia Professional Janssen PS Janssen ORAL 1MG TWICE Prevent Permanent Eye Rolling DAILY ORAL Impairment/Damage Date:05/09/00ISR Number: 3500221-6Report Type:Periodic Company Report #99P-163-0059102-00 (0) Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Depakote (Depakote) Dystonia Professional (Divalproex Sodium) PS Leukopenia Other Risperdal SS ORAL 3 MG, BID, PER ORAL Depakote (Depakote) (Divalproex Sodium) SS ORAL 500 MG, BID, PER ORAL Haldol C Olanzapine C Date:05/10/00ISR Number: 3498120-1Report Type:Direct Company Report # Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Thioridazine PS ORAL 100 MG Q HS Hospitalization - Phosphokinase Increased PO Initial or Prolonged Diabetic Ketoacidosis Risperidone SS ORAL 3 MG Q D PO Required Dyspnoea Lithium C Intervention to Neuroleptic Malignant Depakote C Prevent Permanent Syndrome Impairment/Damage Pharyngolaryngeal Pain Polydipsia Pyrexia Sedation Vision Blurred Date:05/10/00ISR Number: 3499354-2Report Type:Periodic Company Report #99USA11235 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Health Tegretol Tablet 200 Initial or Prolonged Lymphadenopathy Professional Mg (Carbamazepine) PS ORAL 200 MG, BID, Nasopharyngitis ORAL Oedema Risperidone Unknown Pyrexia (Risperidone) SS White Blood Cell Count Increased 22-Feb-2006 08:20 AM Page: 794 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/00ISR Number: 3498723-4Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Risperidol PS ORAL 5MG PO BID Initial or Prolonged Petit Mal Epilepsy Tremor Date:05/11/00ISR Number: 3499199-3Report Type:Expedited (15-DaCompany Report #J081-002-000377 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Aricept PS Eisai Inc ORAL 3 MG, 1 IN 1 Amnesia Health D, PER ORAL Blood Creatine Professional Risperdal Phosphokinase Increased (Risperidone) SS ORAL 1 MG X 2 Blood Lactate TABS, PER Dehydrogenase Increased ORAL Coma Vegetamin B C Facial Pain Tetramide C Hepatic Enzyme Increased Benzalin C Impulse-Control Disorder Insomnia Loss Of Consciousness Neuroleptic Malignant Syndrome Date:05/11/00ISR Number: 3499570-XReport Type:Expedited (15-DaCompany Report #2000UW01557 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Health Seroquel PS Astrazeneca Uk Ltd Hospitalization - Delirium Professional Risperdal SS Initial or Prolonged Fracture Clozapine SS Required Hyponatraemia Intervention to Leukocytosis Prevent Permanent Pneumonia Aspiration Impairment/Damage Respiratory Failure Date:05/12/00ISR Number: 3499659-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000001096 Age:59 YR Gender:Female I/FU:F Outcome PT Death Anxiety Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Cyanosis Decreased Activity Delirium Difficulty In Walking Impulse-Control Disorder Insomnia Neuroleptic Malignant Syndrome Obesity Productive Cough Pyrexia Respiratory Arrest Respiratory Failure 22-Feb-2006 08:20 AM Page: 795 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Rate Decreased Rhabdomyolysis Report Source Product Role Manufacturer Route Dose Duration Foreign Risperidone (Tablet) Health (Risperidone) PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL DAILY, ORAL Zotepine (Zotepine) SS ORAL MG, DAILY, ORAL Pravastatin Sodium (Pravastatin Sodium) SS ORAL MG, DAILY, ORAL Dantrolene Sodium (Dantrolene Sodium) SS ORAL MG, DAILY, ORAL Vegetamin-B (Vegetamin B (R) ) C Triazolam (Triazolam) C Cisapride (Cisapride) C Furosemide (Furosemide) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Quazepam (Quazepam) C Bofu-Tsusho-San (Chinese Herbs) C Date:05/12/00ISR Number: 3499721-7Report Type:Expedited (15-DaCompany Report #JRFUSA1999003642 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Consumer Risperdal (Tablet) Initial or Prolonged Upper Limb Fracture Health (Risperidone) PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL ORAL Cogentin (Benzatropine Mesilate) C Depakate (Valproate Semisodium) C Zoloft (Sertraline Hydrochloride) C Accupril (Quinapril Hydrochloride) C Lasix (Furosemide) C Digoxin (Digoxin) C Zocor (Simavastatin) C Oral Hypoglycemic Nos (Hypoglycemics) C 22-Feb-2006 08:20 AM Page: 796 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/00ISR Number: 3499726-6Report Type:Expedited (15-DaCompany Report #JRFBEL2000001167 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Foreign Risperdal (Tablet) Initial or Prolonged Arrhythmia Health (Risperidone) PS Janssen Research Fdn Convulsion Professional Div Johnson And Loss Of Consciousness Johnson ORAL MG, DAILY, Palpitations ORAL Date:05/12/00ISR Number: 3499731-XReport Type:Expedited (15-DaCompany Report #JRFUSA2000003223 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Consumer Risperdal Health (Unspecified) Professional (Risperidone) PS Janssen Research Fdn Div Johnson And Johnson ORAL ORAL Lasix (Furosemide) C Accupril (Quinapril Hydrochloride) C Digoxin (Digoxin) C Zocor (Simvastatin) C Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Zoloft (Sertraline Hydrochloride) C Oral Hypoglycemic (Hyoglycemics) C Date:05/12/00ISR Number: 3499735-7Report Type:Expedited (15-DaCompany Report #JRFUSA2000003302 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperthermia Malignant Health Risperdal Initial or Prolonged Professional (Unspecified) (Risperidone) PS Janssen Research Fdn Div Johnson And Johnson ORAL ORAL Date:05/12/00ISR Number: 3499832-6Report Type:Expedited (15-DaCompany Report #JACGER2000000374 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Adams-Stokes Syndrome Foreign Risperdal PS Janssen Research Fdn Hospitalization - Electrocardiogram Qt Health Div Johnson And Initial or Prolonged Prolonged Professional Johnson ORAL DAILY, ORAL Sedation Stilnox C Dipiperon C Iso Mack C Beloc Mite C Kalinor C Diclofenac C Antra C Allohexal C 22-Feb-2006 08:20 AM Page: 797 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ambroxol C Date:05/12/00ISR Number: 3499834-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000001212 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Convulsion Health Div Johnson And Professional Johnson ORAL SEE IMAGE Date:05/15/00ISR Number: 3500753-0Report Type:Expedited (15-DaCompany Report #HQ3778619APR2000 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Health Effexor PS Wyeth Ayerst Supraventricular Professional Laboratories Inc ORAL 112.5 MG Ventricular Arrhythmia Other DAILY ORAL Risperidone SS ORAL 0.5 MG 2X PER 1 DAY Date:05/17/00ISR Number: 3501128-0Report Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cachexia Risperdal 2-6mg Initial or Prolonged Condition Aggravated Janssen PS Janssen ORAL 2-6MG QHS PO Laboratory Test Abnormal Medication Error Oedema Peripheral Oral Intake Reduced Schizoaffective Disorder Weight Increased Date:05/17/00ISR Number: 3502747-8Report Type:Expedited (15-DaCompany Report #JACGER2000000597 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Risperdal PS Janssen Research Fdn Hospitalization - Complete Health Div Johnson And Initial or Prolonged Bundle Branch Block Left Professional Johnson ORAL 1.5 MG, 2 IN Required 1 DAY(S), Intervention to ORAL Prevent Permanent Remergil Impairment/Damage (Mirtazapine) C Movergan (Selegiline Hydrochloride) C Madopar (Madopar) C Date:05/17/00ISR Number: 3502748-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000001289 Age: Gender:Female I/FU:I Outcome PT Accidental Overdose Blood Creatine Phosphokinase Increased Extrapyramidal Disorder 22-Feb-2006 08:20 AM Page: 798 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Medication Error Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Pyrexia Foreign Risperdal PS Janssen Research Fdn Rhabdomyolysis Health Div Johnson And Professional Johnson SEE IMAGE Dominal (Prothipendyl Hydrochloride) C Date:05/17/00ISR Number: 3502749-1Report Type:Expedited (15-DaCompany Report #JACGBR2000000274 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypotension Foreign Risperdal PS Janssen Research Fdn Hypothermia Health Div Johnson And Respiratory Arrest Professional Johnson ORAL MG, DAILY, ORAL Iron Sulphate (Ferrous Sulfate) C Nifedipine (Nifedipine) C Buspirone (Buspirone) C Bendrofluazide (Bendroflumethiazide ) C Senokot (Senna Fruit) C Procyclidine (Procyclidine) C Date:05/17/00ISR Number: 3502750-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000000915 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytoclastic Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Vasculitis Health Div Johnson And Rash Maculo-Papular Professional Johnson ORAL MG, DAILY, ORAL Cardegic (Acetylsalicylate Lysine) C Nootropil (Piracetem) C Corvatard (Molsidomine) C Emconcar (Bisoprolol) C Loramet (Lormetazepam) C Zyrtec (Cetirizine Hydrochloride) C Strumazol (Thiamazole) C Glurenorm (Gliquidone) C Nozinan (Levomepromazine) C 22-Feb-2006 08:20 AM Page: 799 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Distraneurine (Clomethiazole Edisilate) C Temesta (Lorazepam) C Date:05/17/00ISR Number: 3562360-3Report Type:Periodic Company Report #S00-USA-00444-01 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Celexa PS Forest Laboratories Professional Inc ORAL SEE IMAGE Risperdal SS ORAL 3 MG QD PO Date:05/18/00ISR Number: 3501470-3Report Type:Direct Company Report # Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Health Imipramine 25 Mg V Intervention to Abnormal Professional Qhs PS 25MG V QHS Prevent Permanent Ventricular Hypertrophy Risperidal 1mg 1/2 Impairment/Damage Qhs SS ORAL 1MG 1/2 QHS Date:05/19/00ISR Number: 3501887-7Report Type:Expedited (15-DaCompany Report #A015177 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Zoloft PS Pfizer Health Pharmaceuticals Inc ORAL 50.00 MG Professional TOTAL:DAILY:O Other RAL Thioridazine SS ORAL 400.00 MG TOTAL:QID:ORA L Risperidone SS ORAL 10.00 MG TOTAL:DAILY:O RAL Zopiclone C Omeprazole C Date:05/22/00ISR Number: 3502681-3Report Type:Expedited (15-DaCompany Report #A016244 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Balance Disorder Health Zoloft PS Pfizer Intervention to Drug Effect Decreased Professional Pharmaceuticals Inc ORAL 50.00 MG Prevent Permanent Drug Interaction TOTAL DAILY Impairment/Damage Epilepsy ORAL Hypotonia Risperdal SS 0.50 MG TOTAL Sedation BID Topiramate C Valproic Acid C 22-Feb-2006 08:20 AM Page: 800 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/22/00ISR Number: 3502993-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000001786 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Atrioventricular Block Health Risperdal PS Janssen Research Fdn Intervention to Complete Professional Div Johnson And Prevent Permanent Johnson ORAL 0.75 MG, Impairment/Damage DAILY, ORAL Thorazine (Chlorpromazine) C Date:05/22/00ISR Number: 3503340-3Report Type:Expedited (15-DaCompany Report #JACGER1999000321 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal Initial or Prolonged Health (Unspecified Tablet) Professional (Risperidone) PS Janssen Research Fdn Company Div Johnson And Representative Johnson ORAL DAILY, ORAL Diazepam (Diazepam) C Date:05/22/00ISR Number: 3503519-0Report Type:Expedited (15-DaCompany Report #JRFBEL2000001285 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Foreign Risperdal PS Janssen Research Fdn Gastric Ulcer Health Div Johnson And Haemoglobin S Decreased Professional Johnson ORAL MG, DAILY, ORAL Sm (Sm) C Trihexyphenidyl Hcl (Trihexyphenidyl Hydrochloride) C Famotidine (Famotidine) C Date:05/22/00ISR Number: 3503520-7Report Type:Expedited (15-DaCompany Report #JRFBEL2000001275 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Foreign Risperdal PS Janssen Research Fdn Electroencephalogram Health Div Johnson And Abnormal Professional Johnson MG, DAILY, Psychotic Disorder Haldol (Unspecified) (Haloperidol) C Levomepromazine Maleate (Levomepromazine Maleate) C Vegetamin A (Vegetamin A) C Valproate Sodium (Valproate Sodium) C Carbamazepine (Carbamazepine) C 22-Feb-2006 08:20 AM Page: 801 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/22/00ISR Number: 3503521-9Report Type:Expedited (15-DaCompany Report #JRFUSA2000003541 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epistaxis Health Risperdal PS Janssen Research Fdn Hospitalization - Feeling Cold Professional Div Johnson And Initial or Prolonged Haemorrhage Johnson ORAL 1 MG, 1 IN 1 Required Mouth Haemorrhage DAY(S), ORAL Intervention to Oesophageal Carcinoma Hydrocodone Prevent Permanent Pulse Absent (Hydrocodone) C Impairment/Damage Respiratory Arrest Docusate Sodium (Docusate Sodium) C Date:05/23/00ISR Number: 3503579-7Report Type:Expedited (15-DaCompany Report #20000300816 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Foreign Atacand PS Astrazeneca Lp ORAL PO Initial or Prolonged Face Oedema Study Risperdal SS Sedation Health Trazodone SS Professional Ascardia C Cedocard C Cystrin C Transipeg C Seroxat "Novo Nordisk" C Date:05/23/00ISR Number: 3503674-2Report Type:Expedited (15-DaCompany Report #J081-002-000377 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Aricept PS Eisai Inc ORAL 3 MG, 1 IN 1 Blood Creatine Health D, PER ORAL Phosphokinase Increased Professional Risperdal Condition Aggravated (Risperidone) SS ORAL 1 MG X 2 Dementia Alzheimer'S Type TABS, PER Facial Pain ORAL Hepatic Function Abnormal Vegetamin B Impulse-Control Disorder (Combination Drug) C Loss Of Consciousness Tetramide (Mianserin Neuroleptic Malignant Hydrochloride) C Syndrome Benzalin (Initrazepam) C Date:05/24/00ISR Number: 3504071-6Report Type:Direct Company Report # Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oculogyration Consumer Risperdal PS 6 WK Date:05/24/00ISR Number: 3504075-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000001303 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Foreign Haldol PS Rw Johnson Initial or Prolonged Sedation Health Pharmaceutical Professional Research Institute Div Ortho Pharm ORAL MG, DAILY, 22-Feb-2006 08:20 AM Page: 802 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Risperdal (Tablet) (Risperidone) SS ORAL MG, DAILY, ORAL Disipal (Orphenadrine Hydrochloride) C Oxabenz (Oxazepam) C Date:05/24/00ISR Number: 3504109-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Risperdal PS 2MG AT 8:00AM Weight Increased Professional + 3MG AT 8:00 PM Depakote 1000mg At 8am + 8pm & 250 Mg At 1 Am SS 1000MG AT 8AM + 8PM & 250 MG AT 1 AM Lithium Cr C Date:05/24/00ISR Number: 3504497-0Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Risperidone Hospitalization - (Risperdal) PS SEE ATTACHED Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Date:05/25/00ISR Number: 3504685-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000001275 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electroencephalogram Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Abnormal Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Haldol (Haloperidol) C Levomepromazine Maleate (Levomepromazine Maleate) C Vegetamin A (Vegetamin A) C Valproate Sodium (Valproate Sodium) C Carbamazepine (Carbamazepine) C 22-Feb-2006 08:20 AM Page: 803 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/00ISR Number: 3505431-XReport Type:Expedited (15-DaCompany Report #JACFRA2000000255 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Bronchospasm Health Div Johnson And Required Respiratory Failure Professional Johnson ORAL 0.5MG, 1 IN 1 Intervention to Company DAY(S), ORAL Prevent Permanent Representative Serevent (Salmeterol Impairment/Damage Xinafoate) C Flixotide (Fluticasone Propionate) C Diamicron (Gliclazide) C Modopar (Madopar) C Renitec (Enalapril Maleate) C Androcur(Cyproterone Acetate) C Athymil (Mianserin Hydrochloride) C Date:05/30/00ISR Number: 3505917-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000001386 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cystitis Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Leukopenia Health Div Johnson And Pyrexia Professional Johnson ORAL MG, DAILY, ORAL Clotiapine (Clotiapine) C Alprazolam (Alprazolam) C Date:05/30/00ISR Number: 3506852-1Report Type:Periodic Company Report #1999-10-0863 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Trilafon PS Schering Corp Sub Other Schering Plough Corp 2 MG Lorazepam Tablets SS ORAL 2 MG ORAL Luvox Tablets SS ORAL UNKNOWN ORAL Riperdal SS UNKNOWN Zyprexa (Olanzapine) SS Date:06/02/00ISR Number: 3507810-3Report Type:Expedited (15-DaCompany Report #JACGER2000000664 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Sedation Consumer Div Johnson And Required Suicide Attempt Health Johnson ORAL 12 MG, 1IN 1 Intervention to Tachycardia Professional TIM(S), ORAL Prevent Permanent Ventricular Fibrillation Melperon (Melperone) SS ORAL 2500 MG, 1IN Impairment/Damage 1 TIME(S), ORAL 22-Feb-2006 08:20 AM Page: 804 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/00ISR Number: 3507812-7Report Type:Expedited (15-DaCompany Report #JACGER2000000711 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sedation Foreign Risperdal (3 Mg Initial or Prolonged Suicide Attempt Health Tablet) Required Tachycardia Professional (Risperidone) PS Janssen Research Fdn Intervention to Div Johnson And Prevent Permanent Johnson ORAL 48 MG, 1 IN Impairment/Damage 1 TIME(S) , ORAL Truxal (Chlorprothixene Hydrochloride) SS ORAL ORAL Atosil (Isopromethazine Hydrochloride) SS ORAL Date:06/02/00ISR Number: 3507813-9Report Type:Expedited (15-DaCompany Report #JACGER2000000750 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Consciousness Health Div Johnson And Respiratory Depression Professional Johnson ORAL 10 TABLE, 1 Suicide Attempt IN 1 TIME(S) , ORAL Paracetamol (Paracetamol) SS ORAL 30000 MG, 1 IN 1 TIME(S), ORAL Alcohol (Ethanol) SS ORAL 1.5 L, 1 IN 1 TIME(S), ORAL Date:06/02/00ISR Number: 3507814-0Report Type:Expedited (15-DaCompany Report #JACGER2000000682 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mydriasis Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Suicide Attempt Health Div Johnson And Required Tachycardia Professional Johnson ORAL ORAL Intervention to Saroten Prevent Permanent (Amitriptyline Impairment/Damage Hydrochloride) SS ORAL 80 MG, 1 IN 1 TIME(S), ORAL Diazepam (Diazepam) SS 150 MG, 1 IN 1 TIME(S) Date:06/02/00ISR Number: 3507817-6Report Type:Expedited (15-DaCompany Report #JACGER2000000765 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Sedation Health Div Johnson And Required Suicide Attempt Professional Johnson ORAL 100 MG, 1 IN Intervention to 1 TIME(S), Prevent Permanent ORAL Impairment/Damage Nipolept (Zotepine) SS ORAL 6000 MG, 1 IN 22-Feb-2006 08:20 AM Page: 805 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 TIME(S), ORAL Date:06/02/00ISR Number: 3507818-8Report Type:Expedited (15-DaCompany Report #JACGER2000000697 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Sedation Health Div Johnson And Suicide Attempt Professional Johnson ORAL 20 MG, 1 IN 1 TIME(S), ORAL Melperon (Melperone) SS ORAL 500 MG, 1 IN 1 TIME(S), ORAL Date:06/02/00ISR Number: 3507819-XReport Type:Expedited (15-DaCompany Report #JACGER2000000706 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Fatigue Health Div Johnson And Suicide Attempt Professional Johnson ORAL 1 IN 1 Tachycardia TIME(S), ORAL Halbmond (Diphenhydramine) SS ORAL 1 IN 1 TIME(S) ORAL Saroten (Amitriptyline Hydrochloride) SS 1 IN 1 TIME(S) Alcohol (Ethanol) SS ORAL ORAL Date:06/02/00ISR Number: 3507820-6Report Type:Expedited (15-DaCompany Report #JACGER2000000691 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Sedation Health Div Johnson And Suicide Attempt Professional Johnson ORAL 42 MG, 1 IN 1 Tachycardia TIME(S), ORAL Stilnox (Zolpidem) SS ORAL 60 MG, 1 IN 1 TIME(S), ORAL Neurocil (Levomepromazine Maleate) SS ORAL 150 MG, 1 IN 1 TIME(S), ORAL Rohypnol (Flunitrazepam) SS ORAL 2 MG, 1 IN 1 TIME(S), ORAL Diazepam "Ratiopharm" (Diazepam) SS ORAL 5 MG, 1 IN 1 TIME(S), ORAL 22-Feb-2006 08:20 AM Page: 806 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/00ISR Number: 3507824-3Report Type:Expedited (15-DaCompany Report #JACGER2000000692 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Fatigue Foreign Risperdal PS Janssen Research Fdn Intervention to Health Div Johnson And Prevent Permanent Professional Johnson ORAL 40 MG, 1 IN 1 Impairment/Damage TIME(S), ORAL Remergil (Mirtazapine) SS ORAL 450 MG, 1 IN 1 TIME(S), ORAL Remestan (Temazepam) SS ORAL 400 MG, 1 IN 1 TIME(S), ORAL Akineton (Biperidan Hydrochloride) SS ORAL 160 MG, 1 IN 1 TIME(S), ORAL Alcohol (Ehtanol) SS ORAL ORAL Date:06/02/00ISR Number: 3507825-5Report Type:Expedited (15-DaCompany Report #JACGER2000000753 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Foreign Risperdal PS Janssen Research Fdn Suicide Attempt Health Div Johnson And Professional Johnson ORAL 50 MG, 1 IN 1 TIME(S), ORAL Levomepromazine (Levomepromazine) SS ORAL 1200 MG, 1 IN 1 TIME(S), ORAL Date:06/02/00ISR Number: 3507827-9Report Type:Expedited (15-DaCompany Report #JACGER2000000714 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sedation Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Suicide Attempt Health Div Johnson And Required Professional Johnson ORAL 150 MG, 1 IN Intervention to 1 TIME(S), Prevent Permanent ORAL Impairment/Damage Akineton Retard (Biperiden Hydrochloride) SS ORAL 60 MG, 1 IN 1 TIME(S), ORAL Solian (Amisulpride) SS ORAL 4000 MG, 1 IN 1 TIME(S),ORAL Neurocil (Levomepromazine Maleate) SS ORAL 250 MG, 1 IN 1 TIME(S), ORAL 22-Feb-2006 08:20 AM Page: 807 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/00ISR Number: 3507828-0Report Type:Expedited (15-DaCompany Report #JACGER2000000734 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Foreign Risperdal PS Janssen Research Fdn Suicide Attempt Health Div Johnson And Professional Johnson ORAL 60 MG, 1 IN 1 TIME(S), ORAL Durazanil (Bromazepam) SS ORAL 48 MG, 1 IN 1 TIME(S), ORAL Diazepam (Diazepam) SS ORAL 4 MG, 1 IN 1 TIME(S), ORAL Date:06/02/00ISR Number: 3507830-9Report Type:Expedited (15-DaCompany Report #JACGER2000000716 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Sedation Health Div Johnson And Professional Johnson ORAL 2 MG, 1 IN 1 TIME(S), ORAL Eunerpan (Melperone Hydrochloride) SS ORAL 100 MG, 1 IN 1 TIME(S), ORAL Tavor (Lorazepam) SS ORAL 4 MG, 1 IN 1 TIME(S), ORAL Taxilan (Perazine) SS ORAL 100 MG, 1 IN 1 TIME(S), ORAL Date:06/02/00ISR Number: 3507831-0Report Type:Expedited (15-DaCompany Report #JACGER2000000748 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coma Foreign Risperdal PS Janssen Research Fdn Completed Suicide Health Div Johnson And Professional Johnson ORAL 10 MG, 1 IN 1 TIME(S), ORAL Sulpiride (Sulpiride) SS ORAL 200 MG, 1 IN 1 TIME(S), ORAL Docepin Dura (Doxepin) SS ORAL 250 MG, 1 IN 1 TIME(S), ORAL Date:06/02/00ISR Number: 3507840-1Report Type:Expedited (15-DaCompany Report #JRFBEL2000001386 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cystitis Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Leukopenia Health Div Johnson And Pyrexia Professional Johnson ORAL MG, DAILY, ORAL Clotiapine (Clotiapine) C 22-Feb-2006 08:20 AM Page: 808 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Alprazolam (Alprazolam) C Date:06/02/00ISR Number: 3507842-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000001423 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Literature Risperdal PS Janssen Research Fdn Initial or Prolonged Akathisia Health Div Johnson And Anxiety Professional Johnson ORAL MG, DAILY, Bradykinesia ORAL Catatonia Lithium Carbonate Cognitive Disorder (Lithium Carbonate) SS MG, DIALY Constipation Paroxetine Depression (Paroxetine) SS MG, DAILY Drug Interaction Olanzapine Dry Mouth (Olanzapine) SS MG, DAILY Fatigue Benztropine Insomnia (Benztropine) SS MG, DAILY Irritability Nortriptyline SS MG, DAILY Mania Muscle Rigidity Parkinsonism Pressure Of Speech Pyrexia Thinking Abnormal Tremor Vision Blurred Date:06/02/00ISR Number: 3507844-9Report Type:Expedited (15-DaCompany Report #JACGER2000000756 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Completed Suicide Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Sedation Health Div Johnson And Professional Johnson ORAL 40 MG, 1 IN 1 TIME(S), ORAL Tafil (Alprazolam) SS ORAL 10 MG, 1 IN 1 TIME(S), ORAL Date:06/02/00ISR Number: 3507846-2Report Type:Expedited (15-DaCompany Report #JACBR2000000339 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Respiratory Arrest Foreign Risperdal PS Janssen Research Fdn Required Health Div Johnson And Intervention to Professional Johnson ORAL MG, DAILY, Prevent Permanent ORAL SEE Impairment/Damage IMAGE Droleptan (Droperidol) SS INTRAVENOUS 5 MG, 1 IN 1 DAY9S), IV Sulpiride (Sulpiride) C 22-Feb-2006 08:20 AM Page: 809 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/00ISR Number: 3508019-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000001411 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Haldol PS Rw Johnson Other Intentional Overdose Health Pharmaceutical Suicide Attempt Professional Research Institute Div Ortho Pharm ORAL DAILY, ORAL Risperidone (Unspecified) ( Risperidone) SS ORAL DAILY, ORAL Promethazine Hcl C Biperiden C Brotizolam C Flunitrazepam C Levomepromazine C Date:06/02/00ISR Number: 3508220-5Report Type:Expedited (15-DaCompany Report #JACGER2000000684 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Risperdal (2 Mg Hospitalization - Coordination Abnormal Health Tablet) Initial or Prolonged Loss Of Consciousness Professional (Risperidone) PS Janssen Research Fdn Required Miosis Div Johnson And Intervention to Psychotic Disorder Johnson ORAL 100 MG, 1 IN Prevent Permanent Sedation 1 TIME(S), Impairment/Damage Suicide Attempt ORAL Tachycardia Nipolept 50 Tremor (Zotepine) SS ORAL 5000 MG, 1 IN 1 TIME(S), ORAL Truxal 50 (Chlorprothixene Hydrochloride) SS ORAL 5000 MG, 1 IN 1 TIME(S), ORAL Diazepam (Diazepam) SS ORAL 200 MG, 1 IN 1 TIME(S), ORAL Date:06/02/00ISR Number: 3508222-9Report Type:Expedited (15-DaCompany Report #JACGER2000000671 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Foreign Risperdal (2 Mg Initial or Prolonged Respiratory Depression Health Tablet) Required Sedation Professional (Risperidone) PS Janssen Research Fdn Intervention to Suicide Attempt Div Johnson And Prevent Permanent Tachycardia Johnson ORAL 100 MG, 1 IN Impairment/Damage 1 TIME(S), ORAL Nipolept 50 (Zotepine) SS ORAL 5000 MG, 1 IN 1 TIME(S), ORAL Truxal 50 (Chlorprothixene Hydrochloride) SS ORAL 5000 MG, 1IN 1 TIME(S), 22-Feb-2006 08:20 AM Page: 810 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Diazepam (Diazepam) SS ORAL 250 MG, 1IN 1 TIME(S), ORAL Date:06/05/00ISR Number: 3508387-9Report Type:Expedited (15-DaCompany Report #AUS/99/01567/LEX Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Clozaril PS Novartis Initial or Prolonged Blood Albumin Decreased Study Pharmaceuticals Corp ORAL 250 MG, ORAL Delirium Health Risperidone Hypoproteinaemia Professional (Risperidone) SS Hypotension Valproate (Valproate Hypoxia Sodium) C Myocarditis Tachycardia Date:06/05/00ISR Number: 3509261-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000001285 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Endoscopy Upper Health Div Johnson And Required Gastrointestinal Tract Professional Johnson ORAL MG. DAILY, Intervention to Abnormal ORAL Prevent Permanent Gastric Ulcer Haemorrhage Trihexyphenidyl Hcl Impairment/Damage Haematocrit Decreased (Trihexyphenidyl Haemoglobin Decreased Hydrochloride) C Hypoproteinaemia Flunitrazepam Red Blood Cell Count (Flunitrazepam) C Decreased Flurazepam Hcl (Flurazepam Hydrochloride) C Sennoside (Sennosides) C Alosenn (Alosenn) C Alprazolam (Alprazolam) C Date:06/05/00ISR Number: 3509262-6Report Type:Expedited (15-DaCompany Report #JRFBEL2000001141 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Duodenal Ulcer Health Div Johnson And Required Perforation Professional Johnson ORAL MG, DAILY, Intervention to Dyspepsia ORAL Prevent Permanent Leukocytosis Impairment/Damage Peritoneal Disorder Peritonitis Date:06/06/00ISR Number: 3508688-4Report Type:Direct Company Report # Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Valproic Acid 250mg Hospitalization - Abbott PS Abbott ORAL 250MG QAM Initial or Prolonged 625MG HS 22-Feb-2006 08:20 AM Page: 811 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Risperidone 0.5mg Janssen SS Janssen ORAL 0.5MG AM 0.5MG HS ORAL Adderall C Date:06/07/00ISR Number: 3508601-XReport Type:Direct Company Report #USP 53111 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Risperdal PS Janssen Rocaltrol SS Roche Date:06/07/00ISR Number: 3509865-9Report Type:Direct Company Report # Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Face Oedema Risperdol 1mg Tab PS ORAL PO 1 DAY Hospitalization - Gingivitis Initial or Prolonged Necrotising Ulcerative Required Gingivostomatitis Intervention to Sepsis Prevent Permanent Stevens-Johnson Syndrome Impairment/Damage Date:06/08/00ISR Number: 3510179-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000001080 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gamma-Glutamyltransferase Health Risperdal PS Janssen Research Fdn Increased Professional Div Johnson And Leukopenia Johnson ORAL 3 MG, 2 IN 1 DAY (S), ORAL Ritalin (Methylphenidate Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:06/08/00ISR Number: 3510687-3Report Type:Expedited (15-DaCompany Report #2000UW01557 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apnoea Health Seroquel PS Astrazeneca Uk Ltd Hospitalization - Convulsion Professional Risperdal SS 4 MG QD Initial or Prolonged Delirium Clozapine SS ORAL 125 MG QD Required Hyponatraemia Intervention to Leukocytosis Prevent Permanent Lower Limb Fracture Impairment/Damage Pneumonia Aspiration Po2 Decreased Respiratory Failure 22-Feb-2006 08:20 AM Page: 812 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/00ISR Number: 3564782-3Report Type:Periodic Company Report #2000UW00926 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Conjunctivitis Health Seroquel PS Astrazeneca Uk Ltd ORAL 600 MG QD PO Dehydration Professional Seroquel SS ORAL 600 MG QD PO Drug Toxicity Risperdal SS ORAL 1 MG BID PO Neuroleptic Malignant Risperdal SS ORAL 3 MG PO Syndrome Risperdal SS ORAL 4 MG QD PO White Blood Cell Count Loxitane SS Decreased Lithium SS Synthroid C Depakote C Date:06/09/00ISR Number: 3510711-8Report Type:Direct Company Report # Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Risperdal 2mg Bid Gynaecomastia (Janssen) PS Janseen ORAL 2MG PO BID Depakote 500mg Bid (Abbott) SS Abbott ORAL 500MG PO BID Date:06/09/00ISR Number: 3510902-6Report Type:Expedited (15-DaCompany Report #JRFBEL2000001096 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Risperdal PS Janssen Research Fdn Hospitalization - Blood Creatine Health Div Johnson And Initial or Prolonged Phosphokinase Increased Professional Johnson ORAL , DAILY, ORAL Cyanosis Zotepine (Xotepine) SS ORAL MG, DAILY, Decreased Activity ORAL Delirium Pravastatin Sodium Impulse-Control Disorder (Pravastatin Sodium) SS ORAL MG, DAILY, Insomnia ORAL Neuroleptic Malignant Dantrolene Sodium Syndrome (Dantrolene Sodium) SS INTRAVENOUS MG, DAILY, IV Productive Cough Vegetamin-B Pyrexia (Vegetamin B(R)) SS ORAL ORAL Respiratory Arrest Triazolam Respiratory Failure (Triazolam) SS ORAL MG, DAILY, Respiratory Rate ORAL Decreased Quazepam (Quazepam) SS ORAL MG, DAILY, Restlessness ORAL Rhabdomyolysis Cisapride (Tablet) Weight Decreased (Cisapride) C Furosemide (Furosemide) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Bofu-Tsusho-San (Chinese Herbs) C 22-Feb-2006 08:20 AM Page: 813 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/00ISR Number: 3510903-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000001386 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cystitis Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Leukopenia Health Div Johnson And Neutropenia Professional Johnson ORAL MG, DAILY, Pyrexia ORAL Clotiapine (Clotiapine) C Alprazolam (Alprazolam) C Date:06/09/00ISR Number: 3510907-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000001275 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Deficit/Hyperactivity Health Div Johnson And Disorder Professional Johnson ORAL MG, DAILY, Condition Aggravated ORAL Confusional State Risperidone (Tablet) Electroencephalogram (Risperidone) SS ORAL MG, DAILY, Abnormal ORAL Emotional Disorder Haldol (Unspecified) Excitability (Haloperidol) SS ORAL MG, DAILY, Psychotic Disorder ORAL Haldol (Tablet) (Haloperidol) SS ORAL MG, DAILY, ORAL Levomepromazine Maleate (Levomepromazine Maleate) SS ORAL MG, DAILY, ORAL Vegetamin A (Vegetamin A) SS ORAL TABLE, DAILY, ORAL Vegetamin B (Vegetamin B (R)) SS ORAL TABLET, DAILY, ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS ORAL MG, DAILY, ORAL Valproate Sodium (Valproate Sodium) C Carbamazeepine (Carbamazepine) C Fluoxetine (Fluoxetine) C Biperiden Hydrochloride (Biperiden Hydrochoride) C Flunitrazepam (Flunitrazepam) C Phenobarbital (Phenobarbital) C 22-Feb-2006 08:20 AM Page: 814 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/00ISR Number: 3510910-5Report Type:Expedited (15-DaCompany Report #JRFBEL1999001434 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Anxiety Health Div Johnson And Required Appendicitis Professional Johnson ORAL MG, DAILY, Intervention to Condition Aggravated ORAL Prevent Permanent Decreased Appetite Biperiden Impairment/Damage Delusion Hydrochloride Hallucination (Biperiden Headache Hydrochloride) C Malaise Clonazepam Pallor (Clonazepam) C Psychotic Disorder Levomepromazine Maleate (Levomepromazine Maleate) C Rilmazafone Hydrochloride (Rilmazafone) C Date:06/09/00ISR Number: 3511605-4Report Type:Expedited (15-DaCompany Report #JAKYO43538 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Foreign Risperdal PS Janssen Research Fdn Dyskinesia Health Div Johnson And Salivary Hypersecretion Professional Johnson ORAL MG, DAILY, Stomatitis ORAL Bromperidol (Unspecified) (Bromperidol) SS ORAL 3 MG, DAILY, ORA;6MG;9MG;6 MG;3MG, DAILY, ORAL Haloperidol Decanoate (Injection) (Haloperidol) SS INTRAMUSCULAR MG, DAILY; MG, DAILY IM Biperiden Hydrochloride (Biperiden Hydrochloride) C Sennoside (Tablet ) (Sennosides) C Tolbutamide(Tablet) (Tolbutamide) C Magnesium Oxide (Magnesium Oxide) C Date:06/09/00ISR Number: 3511607-8Report Type:Expedited (15-DaCompany Report #JRFUSA2000001307 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Risperdal PS Janssen Research Fdn Enuresis Professional Div Johnson And Leukopenia Johnson ORAL 05 MG, 1 IN 1 NIGHT(S) 22-Feb-2006 08:20 AM Page: 815 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Depakote (Valproate Semisodium) C Clonidine (Clonidine) C Date:06/09/00ISR Number: 3511609-1Report Type:Expedited (15-DaCompany Report #JRFBEL2000001505 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cough Foreign Risperdal PS Janssen Research Fdn Hospitalization - Pneumonia Health Div Johnson And Initial or Prolonged Pyrexia Professional Johnson ORAL MG, DAILY, ORAL Haldol (Unspecified)(Halope ridol) C Pantethine (Pantethine) C Date:06/09/00ISR Number: 3511610-8Report Type:Expedited (15-DaCompany Report #JRFUSA2000001301 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Risperdal PS Janssen Research Fdn Enuresis Professional Div Johnson And Laboratory Test Abnormal Johnson ORAL 1 MG, 2 IN 1 DAY(S), ORAL Clonazepam (Clonazepam) C Ritalin (Methylphenidate Hydrochloride) C Clonazepam (Clonazepam) C Ritalin (Methylphenidate Hydrochloride) C Date:06/09/00ISR Number: 3511611-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000001469 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Oedema Foreign Risperdal PS Janssen Research Fdn Depressed Level Of Health Div Johnson And Consciousness Professional Johnson ORAL MG, DAILY, Hyponatraemia ORAL Inappropriate Carbamazepine Antidiuretic Hormone (Carbamazepine) C Secretion Haldol (Unspecified) (Haloperidol) C Date:06/09/00ISR Number: 3511612-1Report Type:Expedited (15-DaCompany Report #JAKYO42924 Age:64 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 816 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Appendicitis Foreign Risperdal PS Janssen Research Fdn Dysuria Health Div Johnson And Hypoproteinaemia Professional Johnson ORAL 2 MG DAILY, Ileus Paralytic ORAL Retroperitoneal Abscess Haloperidol (Injection) (Haloperidol) C Chlorpromazine (Chlorpromazine) C Haloxazolam C Triazolam C Lofepramine Hydrochloride C Date:06/12/00ISR Number: 3512025-9Report Type:Expedited (15-DaCompany Report #JRFBEL2000001532 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Duodenal Ulcer Foreign Risperdal PS Janssen Research Fdn Hospitalization - Haemorrhage Health Div Johnson And Initial or Prolonged Faeces Discoloured Professional Johnson ORAL MG DAILY ORAL Gastrointestinal Haldol (Unspecified) Haemorrhage (Haloperidol) C Ileus Paralytic Biperiden Impetigo Hydrochloride Pancreatic Carcinoma (Biperiden Hydrochloride) C Zopiclone (Zopiclone) C Nitrazepam (Nitrazepam) C Vitaneurin (Thiamine Hydrochloride) C Clomipramine Hydrochloride (Clomipramine Hydrochloride) C Pentobarbital Calcium (Pentobarbital Calcium) C Levomepromazine Maleate (Levomepromazine Maleate) C Date:06/12/00ISR Number: 3512027-2Report Type:Expedited (15-DaCompany Report #JAKYO41054 Age:65 YR Gender:Female I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Anorexia Constipation Depressed Mood Dyskinesia Hypotension 22-Feb-2006 08:20 AM Page: 817 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Rigidity Thinking Abnormal Tremor Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL 4 MG DAILY ORAL; 6 MG DAILY ORAL Levomepromazine Maleate (Levomepromazine) SS ORAL 50 MG DAILY ORAL Sulpiride (Sulpiride) SS OTHER MG DAILY INFUSI Tiapride Hydrochloride (Tiapride) SS ORAL 150 MG DAILY ORAL Amitriptyline Hydrochloride (Tablet) (Amitriptyline) SS ORAL MG DAILY ORAL Mosapramine Hydrochloride (Mosapramine) C ORAL MG DAILY ORAL Trihexyphenidayl Hydrochloride (Trihexyphenidyl) C Pantethine (Pantethine) C Magnesium Oxide (Granules) (Magnesium Oxide) C Etizolam (Etizolam) C Sennoside (Sennosides) C Soldem (Soldem (R)) C Amicaliq (Amino Acids) C Solotax-H (Sodium Chloride) C Date:06/12/00ISR Number: 3512150-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999000060 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Haldol PS Rw Johnson Initial or Prolonged Phosphokinase Increased Health Pharmaceutical Required Chills Professional Research Institute Intervention to Constipation Div Ortho Pharm ORAL MG, DAILY, Prevent Permanent Haematuria ORAL Impairment/Damage Haemorrhage Risperidone SS ORAL MG, DAILY, Infection ORAL Laryngitis Levomepromazine Leukocytosis Maleate Nephrolithiasis (Levomepromazine Neuroleptic Malignant Maleate) SS ORAL MG, DAILY, Syndrome ORAL Pyrexia Halosten C 22-Feb-2006 08:20 AM Page: 818 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Biperiden Hydrochloride C Flunitrazepam C Date:06/12/00ISR Number: 3512356-2Report Type:Expedited (15-DaCompany Report #JRFBEL1999000082 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Keratitis Herpetic Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Timiperone (Timiperone) C Chlorpromazine (Chilorpromazine) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Promethazine Hydrochloride (Promethazine Hydrochloride) C Nifedipine (Nifedipine) C Daio-Kanzo-To (Daiokanzoto) C Sennoside (Sennosides)(Fluphen azine) C Date:06/12/00ISR Number: 3512358-6Report Type:Expedited (15-DaCompany Report #JRFBEL2000001539 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Spastic Paralysis Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Bromperidol(Unspecif ied ) (Bromperidol) C Promethazine (Promethazine) C Levomepromazine (Levomepromazine) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Piroheptine Hydrochloride (Piroheptine) C Marzulene S (Marzulene S) C Brotizolam (Brotizolam) C Diazepam (Diazepam) C Alosenn (Alosenn) C 22-Feb-2006 08:20 AM Page: 819 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nivldipine (Nilvadipine) C Date:06/14/00ISR Number: 3513677-XReport Type:Expedited (15-DaCompany Report #JAKYO42878 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decubitus Ulcer Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Ecchymosis Health Div Johnson And Required Fall Professional Johnson ORAL SEE IMAGE Intervention to Femoral Neck Fracture Haloperidol Prevent Permanent Hepatocellular Damage (Haloperidol) C Impairment/Damage Vegetamin-A (Tablet) (Vegetamin A) C Estazolam (Estazolam) C Sennoside (Tabelt ) (Sennosides) C Carbamazepine (Carbamazepine) C Trihexyphenidyl Hydrochloride (Trihexyphenidyl) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Pentobarbital Calcium (Tablet) (Pentobarbital) C Etizolam (Etizolam) C Triazolam (Tablet) (Triazolam) C Pl (Pl (R)) C Levomepromazine Maleate (Levomepromazine) C Date:06/14/00ISR Number: 3513891-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000001507 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Aminotransferase Health Div Johnson And Required Increased Professional Johnson ORAL ORAL Intervention to Blood Creatine Haloxazolam Prevent Permanent Phosphokinase Increased (Haloxazolam) C Impairment/Damage Subdural Haematoma Vegetamin A (Vegetamin A) C Sennosides (Sennosides) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Haloperidol (Injection) (Haloperidol) C Biperiden Lactate 22-Feb-2006 08:20 AM Page: 820 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Biperiden Lactate) C Levomepromazine Hydrochloride (Levomepromazine Hydrochloride) C Date:06/14/00ISR Number: 3513894-9Report Type:Expedited (15-DaCompany Report #JACGBR2000000164 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Crying Foreign Risperdal PS Janssen Research Fdn Decreased Activity Health Div Johnson And Decreased Appetite Professional Johnson ORAL 2 MG, 1 IN 1 Feeling Abnormal DAY (S), ORAL Hyperhidrosis Sinemet (Sinemet) C Medication Error Ventolin Panic Attack (Salbutamol) C Restlessness Losec (Omeprazole) C Gtn Spray (Glyceryl Trinitrate) C Simvastatin (Simvastatin) C Ismo (Isosorbide Mononitrate) C Furosemdie (Furosemide) C Spironolactone (Spironolactone) C Becotide (Beclometasone Dipropionate) C Date:06/14/00ISR Number: 3516315-5Report Type:Periodic Company Report #JRFUSA1999000190 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Haldol PS Rw Johnson Initial or Prolonged Alopecia Pharmaceutical Anxiety Research Institute Condition Aggravated Div Ortho Pharm ORAL ORAL Convulsion Risperdal Coordination Abnormal (Tablet)(Risperidone Dermatitis ) SS ORAL SEE IMAGE Dystonia Zinc (Zinc) C Gastrointestinal Disorder Headache Hepatocellular Damage Herpes Zoster Hypersensitivity Hypertension Injury Insomnia Muscular Weakness Sedation Tachycardia Thinking Abnormal 22-Feb-2006 08:20 AM Page: 821 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/00ISR Number: 3516316-7Report Type:Periodic Company Report #JRFUSA1999001216 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Haldol PS Rw Johnson Initial or Prolonged Dizziness Pharmaceutical Malaise Research Institute Div Ortho Pharm ORAL ORAL Risperdal (Tablet)(Risperidone ) SS ORAL ORAL Date:06/14/00ISR Number: 3516323-4Report Type:Periodic Company Report #JRFUSA1999002438 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Haldol PS Rw Johnson Initial or Prolonged Professional Pharmaceutical Research Institute INTRAMUSCULAR PRN, IM Risperdal (2 Mg Tablet) (Risperidone) SS ORAL 2 MG, PRN, ORAL Date:06/14/00ISR Number: 3516326-XReport Type:Periodic Company Report #JRFUSA1999002833 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Haldol PS Rw Johnson Initial or Prolonged Professional Pharmaceutical Research Institute Div Ortho Pharm ORAL 10 MG, DAILY, ORAL Risperdal (1 Mg Tablet) (Risperidone) SS ORAL 1 MG, 2 IN 1 DAY(S), ORAL Date:06/14/00ISR Number: 3516330-1Report Type:Periodic Company Report #JRFUSA2000000014 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Haldol PS Rw Johnson Initial or Prolonged Pharmaceutical Research Institute Div Ortho Pharm ORAL ORAL Risperdal (Tablet)(Risperidone ) SS ORAL SEE IMAGE Cogentin (Benzatropine Mesilate) C Ativan (Lorazepam) C 22-Feb-2006 08:20 AM Page: 822 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/00ISR Number: 3516335-0Report Type:Periodic Company Report #JRFUSA2000000064 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Haldol PS Rw Johnson Initial or Prolonged Neuroleptic Malignant Professional Pharmaceutical Required Syndrome Research Institute Intervention to Div Ortho Pharm ORAL ORAL Prevent Permanent Haldol Decanoate Impairment/Damage (100 Mg/Ml Injection)(Haloperid ol Decanoate) SS INTRAMUSCULAR 100 MG, 1 IN 1 MONTH(S), IM Risperdal (Tablet)(Risperidone ) SS ORAL 2 MG, 1 IN 1 DAY(S), ORAL Klonopin (Clonazepam) C Depakote (Valproate Semisodium) C Date:06/14/00ISR Number: 3536890-4Report Type:Periodic Company Report #HQ4304102NOV1999 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Arteriosclerosis Consumer Artane PS Lederle Laboratories Dizziness Div American Pain In Extremity Cyanamid Co ORAL 2 MG 3X PER 1 Panic Disorder DAY, ORAL Tardive Dyskinesia Risperdal SS ORAL 3 MG 2X PER 1 DAY, ORAL Lithium C Nolvadex C Stelazine C Date:06/14/00ISR Number: 3538089-4Report Type:Periodic Company Report #PRIUSA1999003679 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cellulitis Consumer Haldol PS Rw Johnson Dermatitis Pharmaceutical Dysphagia Research Institute Hyperhidrosis Div Ortho Pharm Paraesthesia Risperdal (Risperidone) SS Erythromycin (Erythromycin) SS Date:06/14/00ISR Number: 3538169-3Report Type:Periodic Company Report #JRFUSA1999001663 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Consumer Haldol PS Rw Johnson Confusional State Pharmaceutical Dry Mouth Research Institute Gait Disturbance Div Ortho Pharm ORAL SEE IMAGE Sedation Risperdal (1 Mg 22-Feb-2006 08:20 AM Page: 823 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablet) (Risperidone) SS ORAL SEE IMAGE Paxil C Effexor C Aricept C Date:06/14/00ISR Number: 3538170-XReport Type:Periodic Company Report #JRFUSA2000001377 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Consumer Haldol PS Rw Johnson Fatigue Pharmaceutical Research Institute Div Ortho Pharm ORAL ORAL Haldol (Injection) (Haloperidol) SS INTRAMUSCULAR IM Risperdal (Tablet) (Risperidone) SS ORAL 5 MG, DAILY, PO Date:06/14/00ISR Number: 3538171-1Report Type:Periodic Company Report #JRFUSA1999001854 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Attention Health Haldol PS Rw Johnson Deficit/Hyperactivity Professional Pharmaceutical Disorder Research Institute INTRAMUSCULAR IM Malaise Risperdal (Tablet) (Risperidone) SS ORAL SEE IMAGE Ativan C Oxycontin C Date:06/14/00ISR Number: 3538172-3Report Type:Periodic Company Report #JRFUSA2000000250 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypotension Health Haldol PS Rw Johnson Syncope Professional Pharmaceutical Research Institute ORAL 17.5 MG, DAILY, ORAL Risperdal (3 Mg Tablet) (Risperidone) SS ORAL 3 MG, 2 IN 1 DAY (S) , ORAL Date:06/15/00ISR Number: 3514558-8Report Type:Expedited (15-DaCompany Report #A018811 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dementia Foreign Zoloft PS Pfizer Intervention to Disorientation Health Pharmaceuticals Inc ORAL ORAL Prevent Permanent Professional Risperdal SS Impairment/Damage Company Representative 22-Feb-2006 08:20 AM Page: 824 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/00ISR Number: 3515666-8Report Type:Expedited (15-DaCompany Report #JRFBEL1999000413 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Risperidone PS Janssen Research Fdn Blood Creatine Health Div Johnson And Phosphokinase Increased Professional Johnson ORAL MG, DAILY , Constipation ORAL Cystitis Zotepine SS ORAL MG,DAILY,ORAL Hepatic Enzyme Increased Furosemide SS ORAL MG,DAILY,ORAL Hypokalaemia Fluphenazine SS INTRAMUSCULAR 75 MG, 1 IN 4 Ileus Paralytic WEEKS, IM Parkinsonism Trihexyphenidyl SS ORAL DAILY,ORAL Respiratory Arrest Sennosides C Vomiting Spironolactone C White Blood Cells Urine Dihydroergotamine C Positive Flunitrazepam C X-Ray Abnormal Potassium Chloride C Amantadine Hydrochloride C Biperiden C Sparflozacin C Date:06/21/00ISR Number: 3517312-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000004381 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Risperdal PS Janssen Research Fdn Initial or Prolonged Thrombocytopenia Professional Div Johnson And Johnson ORAL ORAL Seroquel (Seroquel) C Ativan (Lorazepam) C Trazodone (Trazodone) C Date:06/21/00ISR Number: 3517313-8Report Type:Expedited (15-DaCompany Report #JRFUSA2000004410 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Health Risperdal PS Janssen Research Fdn Initial or Prolonged Feeling Hot And Cold Professional Div Johnson And Required Myoglobinuria Johnson ORAL 1 MG, 1 IN 1 Intervention to DAY(S), ORAL Prevent Permanent 1.75 MG, 1 Impairment/Damage IN 1 DAY(S), ORAL Prozac (Fluoxetine Hydrochloride) C Adderall (Obetrol) C Date:06/21/00ISR Number: 3517314-XReport Type:Expedited (15-DaCompany Report #JRFUSA2000000095 Age:52 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:20 AM Page: 825 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Aggression Consumer Risperdal PS Janssen Research Fdn Akathisia Div Johnson And Arthralgia Johnson ORAL SEE IMAGE Asthenia Haloperidol Bradykinesia (Haloperidol) SS ORAL 2 MG, 4 IN 1 Cardiac Arrest DAY (S), ORAL Chest Pain Ativan (Lorazepam) SS ORAL 2 MG, 4 IN 1 Difficulty In Walking DAY (S), ORAL Drug Withdrawal Syndrome Olanzapine Memory Impairment (Olanzapine) C Muscle Rigidity Overdose Parkinson'S Disease Peripheral Coldness Pulse Absent Red Blood Cell Count Decreased Restlessness Sleep Disorder Tachycardia Tardive Dyskinesia Tremor Weight Decreased White Blood Cell Count Decreased Date:06/21/00ISR Number: 3517315-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000000591 Age:12 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal PS Janssen Research Fdn Initial or Prolonged Leukopenia Professional Div Johnson And Neutropenia Johnson ORAL 2 MG, 2 IN 1 Psychotic Disorder DAY (S), ORAL 1 MG, 2 IN 1 DAY (S), ORAL Imipramine (Imipramine) C Multivit (Multivit) C Date:06/21/00ISR Number: 3517432-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000004138 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Perforation Health Risperdal PS Janssen Research Fdn Initial or Prolonged Professional Div Johnson And Required Johnson ORAL 4 MG, 1 IN 1 Intervention to NIGHT(S), Prevent Permanent ORAL Impairment/Damage 22-Feb-2006 08:20 AM Page: 826 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/00ISR Number: 3517435-1Report Type:Expedited (15-DaCompany Report #JACFRA200000399 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Catatonia Foreign Risperdal PS Janssen Research Fdn Hospitalization - Confusional State Health Div Johnson And Initial or Prolonged Professional Johnson ORAL MG, DAILY, ORAL Urbanyl (Clobazam) C Date:06/21/00ISR Number: 3517436-3Report Type:Expedited (15-DaCompany Report #JACGER2000000956 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Foreign Risperdal PS Janssen Research Fdn Urinary Tract Infection Study Div Johnson And Health Johnson ORAL MG, DAILY, Professional ORAL (SEE IMAGE) Biperiden (Biperiden) C Akatinol (Memantine Hydrochloride) C Biperiden (Biperiden) C Date:06/23/00ISR Number: 3518782-XReport Type:Expedited (15-DaCompany Report #JRFUSA2000004283 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Risperdal PS Janssen Research Fdn Condition Aggravated Div Johnson And Coordination Abnormal Johnson ORAL 0.5 MG, 1 IN Dysphagia 1 DAY(S), Speech Disorder ORAL Antihypertensives (Antihypertensives) C Date:06/23/00ISR Number: 3518783-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000004281 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Consumer Risperdal PS Janssen Research Fdn Initial or Prolonged Kidney Infection Div Johnson And Required Johnson ORAL ORAL Intervention to Prozac (Fluoxetine Prevent Permanent Hydrochloride) C Impairment/Damage Cogentin (Benzatorpine Mesilate) C Date:06/23/00ISR Number: 3518784-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000004280 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pancytopenia Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL 2 MG, 2 IN 1 22-Feb-2006 08:20 AM Page: 827 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY(S), ORAL Bactrim (Bactrim) SS Date:06/23/00ISR Number: 3518786-7Report Type:Expedited (15-DaCompany Report #JAOCAN2000000462 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Risperdal PS Janssen Research Fdn Disability Depression Health Div Johnson And Dyskinesia Professional Johnson ORAL 0.5 MG, 2 IN Tardive Dyskinesia 1 DAY(S), ORAL Verapamil (Verapamil) C Colace (Docusate Sodium) C Tylenol (Paracetamol) C Senokot (Senna Fruit) C Date:06/23/00ISR Number: 3518788-0Report Type:Expedited (15-DaCompany Report #JACFRA2000000410 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Health Div Johnson And Professional Johnson ORAL Ikaran (Dihydroergotamine Mesilate) SS ORAL ORAL Tercian (Cyamemazine) SS ORAL ORAL Lactulose (Lactulose) SS ORAL ORAL Tranxene (Clorazepate Dipotassium) SS ORAL ORAL Deroxat (Paroxetine Hydrochloride) SS ORAL ORAL Date:06/23/00ISR Number: 3518789-2Report Type:Expedited (15-DaCompany Report #JRFBEL2000001582 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Foreign Risperdal PS Janssen Research Fdn Drug Interaction Literature Div Johnson And Encephalopathy Health Johnson MG, DAILY, Extrapyramidal Disorder Professional UNKNOWN Grand Mal Convulsion Doxepin (Doxepin) SS BIPOLAR Hepatic Enzyme Increased AFFECTIVE Sedation DISORDERR, Tremor UNSPECIFIED Valproic Acid (Valproic Acid) SS DAILY, UNKNOWN Biperiden (Biperiden) SS DAILY, UNKNOWN 22-Feb-2006 08:20 AM Page: 828 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam (Lorazepam) C Date:06/27/00ISR Number: 3519981-3Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Risperidone PS ORAL 4MG QD PO Initial or Prolonged Confusional State Other Hyponatraemia Date:06/27/00ISR Number: 3520142-2Report Type:Direct Company Report # Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Risperidone 1 Mg Hospitalization - Tablet Jansen PS Jansen ORAL 1 MG BID ORAL Initial or Prolonged Date:06/27/00ISR Number: 3520944-2Report Type:Expedited (15-DaCompany Report #JACFRA2000000405 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Depressed Level Of Health Div Johnson And Consciousness Professional Johnson ORAL ORAL Electrocardiogram Qt Seropram C Prolonged Benzodiazepine Malaise Derivatives C Date:06/27/00ISR Number: 3520945-4Report Type:Expedited (15-DaCompany Report #JACGER2000000971 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Petechiae Foreign Risperdal PS Janssen Research Fdn Thrombocytopenia Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Date:06/27/00ISR Number: 3520948-XReport Type:Expedited (15-DaCompany Report #JRFUSA2000004434 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Arrest Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Company Johnson Representative Date:06/27/00ISR Number: 3520950-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000001285 Age:47 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:20 AM Page: 829 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Upper Foreign Risperdal PS Janssen Research Fdn Gastric Ulcer Haemorrhage Health Div Johnson And Haematocrit Decreased Professional Johnson ORAL MG, DAILY, Haemoglobin Decreased ORAL Hypoproteinaemia Trihexyphenidyl Hcl SS ORAL MG, DAILY, Protein Total Decreased ORAL Red Blood Cell Count Flunitrazepam SS ORAL MG, DAILY, Decreased ORAL Flurazepam Hcl SS ORAL MG, DAILY, ORAL Sennoside SS ORAL MG, ORAL Alosenn SS ORAL G, DAILY, ORAL Alprazolam SS ORAL MG, DAILY, ORAL Date:06/28/00ISR Number: 3521600-7Report Type:Expedited (15-DaCompany Report #JRFBEL2000001594 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Risperdal PS Janssen Research Fdn Blood Follicle Literature Div Johnson And Stimulating Hormone Health Johnson Decreased Professional Flunitracepam Blood Prolactin Increased (Flunitrazepam) SS Bone Disorder Central Nervous System Neoplasm Cerebrovascular Disorder Depression Dizziness Fall Gait Disturbance Headache Mood Altered Nervous System Disorder Nuclear Magnetic Resonance Imaging Abnormal Optic Nerve Disorder Prolactinoma Social Avoidant Behaviour Visual Field Defect Visual Pathway Disorder Vomiting Date:06/29/00ISR Number: 3522247-9Report Type:Expedited (15-DaCompany Report #00P-167-0091164-00 (0) Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyspnoea Foreign Depakene PS Abbott Laboratories Intervention to Hypercalcaemia Health Pharmaceutical Prevent Permanent Professional Products Div ORAL 200 MG, 1 IN Impairment/Damage 1 D, PER ORAL Risperidone (Risperidone) SS ORAL 1 MG, 1 IN 1 22-Feb-2006 08:20 AM Page: 830 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report EVERY OTHER DAY, PER ORAL; 2 MG, 1 IN 1 EVERY Paroxetine (Paroxetine) SS ORAL 40 MG, 1 IN 1 D, PER ORAL Amlodipine C Furosemide C Acetylsalicylic Acid C Levothyroxine Sodium C Date:06/30/00ISR Number: 3522968-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000001469 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Anxiety Health Div Johnson And Brain Oedema Professional Johnson ORAL MG, DAILY, Convulsion ORAL Depressed Level Of Carbamazepine C Consciousness Haldol C Hyponatraemia Levomepromazine Inappropriate Meleate C Antidiuretic Hormone Dimeticone C Secretion Biperiden Logorrhoea Hydrochloride C Restlessness Pantethine C Flunitrazepam C Promethazine Hydrochloride C Magnesium Oxide C Bromvalerylurea C Nitrazepam C Sennoside C Alosenn C Diazepam C Date:06/30/00ISR Number: 3522973-1Report Type:Expedited (15-DaCompany Report #JACGER2000000597 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Risperdal PS Janssen Research Fdn Life-Threatening Complete Health Div Johnson And Hospitalization - Bundle Branch Block Left Professional Johnson ORAL 1.5 MG, 2 IN Initial or Prolonged Cardiac Failure 1 DAY(S), Required ORAL;1 MG, 2 Intervention to IN 1 DAY, Prevent Permanent ORAL Impairment/Damage Haldol (Haloperidol) SS MG ,DAILY Remergil (Mirtazapine) C Movergan (Selegiline Hydrochoride) C Madopar (Madopar C 22-Feb-2006 08:20 AM Page: 831 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/00ISR Number: 3522974-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000001608 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Systolic Foreign Risperdal PS Janssen Research Fdn Decreased Literature Div Johnson And Dizziness Health Johnson MG, DAILY, Drug Interaction Professional ORAL Dyskinesia Midodrine Dystonia (Medodrine) SS MG, DAILY Oculogyration Orthostatic Hypotension Torticollis Date:06/30/00ISR Number: 3522975-5Report Type:Expedited (15-DaCompany Report #JACGBR2000000431 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Encephalopathy Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL ORAL Date:06/30/00ISR Number: 3522976-7Report Type:Expedited (15-DaCompany Report #JACGER2000001034 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusional Disorder, Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Persecutory Type Health Div Johnson And Dyspnoea Professional Johnson ORAL MG, DAILY, Erysipelas ORAL Face Oedema Tramal (Tramadol Oedema Peripheral Hydrochloride) C Diazepam (Diazepam) C Diclofenac (Diclofenac) C Jodid (Potassium Iodide) C Date:06/30/00ISR Number: 3522977-9Report Type:Expedited (15-DaCompany Report #JRFUSA2000004281 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Consumer Risperdal PS Janssen Research Fdn Initial or Prolonged Kidney Infection Health Div Johnson And Required Urinary Tract Infection Professional Johnson ORAL ORAL Intervention to Prozac (Fluoxetine Prevent Permanent Hydrochloride) C Impairment/Damage Cogentin (Benzatropine Mesilate) C Date:07/03/00ISR Number: 3524561-XReport Type:Expedited (15-DaCompany Report #JACGER2000001037 Age:52 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:20 AM Page: 832 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Foreign Risperdal PS Janssen Research Fdn Condition Aggravated Health Div Johnson And Dysphagia Professional Johnson ORAL MG, Gastrointestinal Disorder DAILY,ORAL Hyperpyrexia Cipramil Lung Infiltration (Citalopram) SS ORAL MG, DAILY, Mastication Disorder ORAL Metastases To Lung Saroten C Pneumonia Aspiration Tavor C Speech Disorder Date:07/03/00ISR Number: 3524571-2Report Type:Expedited (15-DaCompany Report #JRFBEL2000001617 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fall Literature Risperdal PS Janssen Research Fdn Hallucination, Auditory Health Div Johnson And Hip Fracture Professional Johnson ORAL 1 MG, 1 IN 1 Paranoia DAY(S), ORAL Torticollis Lorazepam C Trifluoperazine C Trazodone C Thyroxine C Bactrim Ds C Timolol C Olanzapine C Benztropine C Date:07/03/00ISR Number: 3524576-1Report Type:Expedited (15-DaCompany Report #JRFBEL2000001618 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Literature Risperdal PS Janssen Research Fdn Initial or Prolonged Condition Aggravated Health Div Johnson And Confusional State Professional Johnson ORAL 0.5 MG, 1 IN1 Decreased Appetite DAY (S), ORAL Depression Donepezil C Dystonia Docusate C Hallucination Hydrochlorothiazide C Myasthenia Gravis Benztropine C Neck Pain Diphenhydramine C Paranoia Vitamin E C Psychotic Disorder Clozapine C Suicidal Ideation Tension Thinking Abnormal Torticollis Date:07/03/00ISR Number: 3524579-7Report Type:Expedited (15-DaCompany Report #JRFBEL2000001620 Age:63 YR Gender:Female I/FU:I Outcome PT Aggression Agitation Eating Disorder 22-Feb-2006 08:20 AM Page: 833 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fall Pelvic Fracture Tearfulness Report Source Product Role Manufacturer Route Dose Duration Torticollis Literature Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Lorazepam C Metoprolol C Calcium C Vitamin C Miacalcin C Multivitamin C Sertraline C Trazodone C Date:07/03/00ISR Number: 3524585-2Report Type:Expedited (15-DaCompany Report #JRFBEL2000001643 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Asthenia Health Div Johnson And Blood Folate Decreased Professional Johnson ORAL 1 MG, Blood Iron Decreased DAILY,ORAL C-Reactive Protein Sobril C Increased Duroferon C Decreased Activity Ismo C Decreased Appetite Seloken C Depressed Mood Depression Dyskinesia Dysphagia Haematochezia Haemoglobin Increased Joint Stiffness Leukocytosis Nervous System Disorder Parkinsonism Red Blood Cell Sedimentation Rate Increased Thrombocythaemia Transferrin Decreased Tremor Weight Decreased Date:07/03/00ISR Number: 3524587-6Report Type:Expedited (15-DaCompany Report #JRFBEL2000001646 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Electrolytes Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Decreased Health Div Johnson And Required Condition Aggravated Professional Johnson ORAL MG, DAILY, Intervention to Confusional State ORAL Prevent Permanent Fatigue Thacapzol SS ORAL MG, Impairment/Damage Haemoglobin Decreased DAILY,ORAL Hypothermia Lasix Retard SS ORAL MG, Thrombocytopenia DAILY,ORAL Imovane C 22-Feb-2006 08:20 AM Page: 834 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Midamor C Cipramil C Fosamax C Calcichew C Date:07/05/00ISR Number: 3524320-8Report Type:Expedited (15-DaCompany Report #239346 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Foreign Valium PS Hoffmann La Roche Therapeutic Study Inc INTRAVENOUS 30 MG DAILY ; Mania Health 10 MG DAILY Pulse Absent Professional INTRAVENOUS Respiratory Arrest Quilonium Retard Stupor (Lithium Carbonate) SS 1350 MG DAILY Orfiril (Valproate Sodium) SS 600 MG DAILY Truxal (Chlorprothixene) SS INTRAVENOUS 150 MG DAILY; 100 MG INTRAVENOUS ; 100 MG DAILY ORAL Risperdal (Risperidone) SS 6 MG DAILY Amaryl (Glimepiride) C Pirenzepine (Pirenzepine Hydrochloride) C Heparin (Heparin Sodium) C Date:07/05/00ISR Number: 3524808-XReport Type:Expedited (15-DaCompany Report #239584 Age:42 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Bactrim PS Hoffmann La Roche Initial or Prolonged Neutrophil Count Professional Inc Decreased Risperdal Pancytopenia (Risperidone) 2 Mg SS ORAL 2 MG 2 PER Psychotic Disorder DAY ORAL Pyrexia Thrombocytopenia Date:07/06/00ISR Number: 3525637-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000001411 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Contusion Foreign Risperdal PS Janssen Research Fdn Completed Suicide Health Div Johnson And Intentional Overdose Professional Johnson ORAL MG DAILY ORAL Skull Fracture Haldol (Haloperidol) C Promethazine Hcl (Promethazine Hydrochloride) C Biperiden Hcl (Biperiden Hydrochloride) C 22-Feb-2006 08:20 AM Page: 835 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Brotizolam (Brotizolam) C Flunitrazepam (Flunitrazepam) C Levomepromazine (Levomepromazine) C Date:07/06/00ISR Number: 3525676-2Report Type:Expedited (15-DaCompany Report #JRFUSA2000000095 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Haldol PS Rw Johnson Initial or Prolonged Akathisia Pharmaceutical Required Arthralgia Research Institute Intervention to Asthenia Div Ortho Pharm ORAL 2 MG 4 IN 1 Prevent Permanent Bradykinesia DAY(S) ORAL Impairment/Damage Cardiac Arrest Risperdal (Tablet) Chest Pain (Risperidone) SS ORAL 3 MG 2 IN 1 Difficulty In Walking DAY(S) ORAL Drug Withdrawal Syndrome Risperdal (Tablet) Feeling Cold (Risperidone) SS ORAL 7 MG DAILY Headache ORAL Memory Impairment Risperdal (Tablet) Muscle Rigidity (Risperidone) SS ORAL 6 MG DAILY Nausea ORAL Overdose Risperdal (Tablet) Parkinson'S Disease (Risperidone) SS ORAL 7.5 MG DAILY Red Blood Cell Count ORAL Decreased Risperdal (Tablet) Restlessness (Risperidone) SS ORAL 8.5 MG DAILY Sleep Disorder ORAL Tachycardia Ativan (Lorazepam) SS ORAL 2 MG 4 IN 1 Tardive Dyskinesia DAY (S) ORAL Tremor Olanzapine Weight Decreased (Olanzapine) C White Blood Cell Count Increased Date:07/07/00ISR Number: 3526596-XReport Type:Expedited (15-DaCompany Report #JACGER2000000597 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Haldol PS Rw Johnson Life-Threatening Complete Health Pharmaceutical Hospitalization - Bundle Branch Block Left Professional Research Institute Initial or Prolonged Cardiac Failure Div Ortho Pharm DAILY Required Electrocardiogram Risperdal (1 Mg/Ml Intervention to Abnormal Solution) Prevent Permanent (Risperidone) SS ORAL 1.5 MG, 2 IN Impairment/Damage 1 DAY (S), ORAL; 1 MG, 2 IN 1 DAY (S), ORAL Remergil C Movergan C Madopar C 22-Feb-2006 08:20 AM Page: 836 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/10/00ISR Number: 3527266-4Report Type:Expedited (15-DaCompany Report #00GB-10507 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Ritalin Tab PS Novartis Initial or Prolonged Priapism Health Pharmaceuticals Corp ORAL DAILY , ORAL Professional Risperidone Other (Risperidone) SS Date:07/10/00ISR Number: 3527316-5Report Type:Direct Company Report # Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Respiradone PS PRIOR TO Hyperpyrexia ADMISSION Mental Impairment Perfenazine SS Muscle Rigidity Valproic Acid SS PRIOR TO Neuroleptic Malignant ADMISSION Syndrome Perfenazine SS Neutropenia Clonazepam C Renal Failure Tussin Dm C Rhabdomyolysis Augmentin C Thrombocytopenia Tylenol C Respiridone C Date:07/11/00ISR Number: 3527342-6Report Type:Expedited (15-DaCompany Report #JRFBEL2000001663 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ascites Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Ovarian Cancer Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Haldol (Haloperidol) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Promethazine Hydrochloride (Promethazine Hydrochloride) C Vegetamin B (Vegetamin B (R) ) C Flunitrazepam (Flunitrazepam) C Sennosides (Sennosides) C Doxifluridine (Doxifluridine) C Tamoxifen Citrate (Tamoxifen Citrate) C Teprenone (Teprenone) C Glibenclamide (Glibenclamide) C 22-Feb-2006 08:20 AM Page: 837 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/00ISR Number: 3527346-3Report Type:Expedited (15-DaCompany Report #JRFBEL1999000582 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Aggression Health Div Johnson And Condition Aggravated Professional Johnson ORAL SEE IMAGE Dystonia Haloperidol Gastric Ulcer (Haloperidol) C Haematemesis Biperiden Impulsive Behaviour Hydrochloride Mallory-Weiss Syndrome (Biperiden Medication Error Hydrochloride) C Movement Disorder Schizophrenia Date:07/11/00ISR Number: 3527347-5Report Type:Expedited (15-DaCompany Report #JAOCAN2000000539 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Detachment Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Celexa (Citalopram Hydrobromide) SS ORAL ORAL Acetaminophen (Paracetamol) C Date:07/11/00ISR Number: 3527350-5Report Type:Expedited (15-DaCompany Report #JACFRA2000000459 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Exposure To Therapeutic Health Div Johnson And Drugs Professional Johnson ORAL 2 MG, 1 IN 1 Drug Withdrawal Syndrome DAY(S), ORAL; Neonatal UTERINE Tercian (Cyamemazine) SS ORAL DAILY ORAL; UTERINE Methadone (Methadone) SS ORAL 70 MG, 1 IN 1 DAY(S), ORAL; UTERINE Date:07/11/00ISR Number: 3527352-9Report Type:Expedited (15-DaCompany Report #JACGER2000000992 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Study Div Johnson And Health Johnson ORAL 1 MG, 2 IN 1 Professional DAY(S), ORAL Timonil (Carbamazepine) C Valoron N (Valoron N) C 22-Feb-2006 08:20 AM Page: 838 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dipiperon (Pipamperone) C Zantac (Ranitidine Hydrochloride) C Bifiteral (Lactulose) C Date:07/11/00ISR Number: 3527834-XReport Type:Expedited (15-DaCompany Report #HQ8196206JUL2000 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Surmontil PS Wyeth Ayerst Dysphemia Professional Laboratories Inc ORAL SEE IMAGE Muscle Twitching ORAL 14 DAY Visual Acuity Reduced Risperidone (Risperidone) SS ORAL SEE IMAGE / ORAL 8 DAY Levothyroxine C Date:07/12/00ISR Number: 3528447-6Report Type:Expedited (15-DaCompany Report #S00-GER-00965-01 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Celexa PS Forest Laboratories Initial or Prolonged Cough Health Inc 20 MG QD Dysphagia Professional Cipramil (Citalopram Hypokinesia Other Hydrobromide) SS 40 MG QD Mastication Disorder Cipramil (Citalopram Pyrexia Hydrobromide) SS 60 MG QD NG Speech Disorder Cipramil (Citalopram Tachypnoea Hydrobromide) SS 50 MG QD NG Tongue Paralysis Risperdal (Risperidone) SS 6 MG QD Risperdal (Risperidone) SS 8 MG QD Risperdal (Risperidone) SS 6 MG QD Risperdal (Risperidone) SS 8 MG QD NG Risperdal (Risperidone) SS 6 MG QD NG Saroten (Amitriptyline Hydrochloride) C Tavor (Lorazepam) C Date:07/13/00ISR Number: 3528978-9Report Type:Expedited (15-DaCompany Report #JRFUSA2000000415 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Risperdal PS Janssen Research Fdn Div Johnson And Johnson ORAL 4 MG, 2 IN 1 DAY(S), ORAL Depakote (Valproate Semisodium) C Zoloft (Sertraline Hydrochloride) C 22-Feb-2006 08:20 AM Page: 839 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/13/00ISR Number: 3528990-XReport Type:Expedited (15-DaCompany Report #JRFUSA2000002001 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal PS Janssen Research Fdn Initial or Prolonged Delirium Professional Div Johnson And Required Fibula Fracture Johnson ORAL 9 MG, DAILY, Intervention to Hyponatraemia ORAL Prevent Permanent Leukocytosis Clozapine Impairment/Damage Lower Limb Fracture (Clozapine) SS ORAL ORAL Pneumonia Aspiration Seroquel (Seroquel) SS ORAL ORAL Respiratory Distress Respiratory Failure Tibia Fracture Date:07/13/00ISR Number: 3529059-0Report Type:Expedited (15-DaCompany Report #9843322 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Consumer Zoloft PS Pfizer Initial or Prolonged Abnormal Behaviour Pharmaceuticals Inc ORAL 25.00 MG Required Aggression TOTAL: Intervention to Agitation DAILY:ORAL Prevent Permanent Anger Aricept SS Impairment/Damage Angina Pectoris Xanax SS Arthritis Risperidol SS ORAL 1.50 MG Cerebrovascular Accident TOTAL:BID: Depression ORAL Dermatitis Ben Gay C Diarrhoea Zyprexa C Dizziness Klonopin C Drug Ineffective Serzone C Drug Interaction Unspecified Hallucination Antioxidants C Hypersomnia Tylenol C Kyphosis Vitamins C Nervousness St. John'S Wort C Sedation Cardizem Cd C Thinking Abnormal Gingko C Tremor Celebrex C Vomiting Ativan C Date:07/13/00ISR Number: 3529230-8Report Type:Expedited (15-DaCompany Report #200012981DDC Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Electrolytes Foreign Furosemide (Lasix Initial or Prolonged Decreased Health Retard) PS ORAL 30 MG/DAY PO Other Hypothermia Professional Risperidone Pancytopenia Other (Risperdal) SS Thiamazole (Thacapzol) SS Zopiclone (Imovane) C Amiloride Hydrochloride (Midamor) C Citalopram Hydrochloride (Cipramil) C Alendronate Sodium 22-Feb-2006 08:20 AM Page: 840 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Fosamax) C Colecalciferol C Calcium Carbonate (Calcichew-D3) C Date:07/13/00ISR Number: 3529308-9Report Type:Expedited (15-DaCompany Report #JACGBR2000000465 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sleep Apnoea Syndrome Foreign Risperdal PS Janssen Research Fdn Vaginal Haemorrhage Health Div Johnson And Professional Johnson Date:07/13/00ISR Number: 3529309-0Report Type:Expedited (15-DaCompany Report #JACFRA2000000478 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL 2 MG, 6 IN 1 WEEK(S), ORAL Temesta (Lorazepam) C Stilnox (Zolpidem) C Euphytose (Euphytose) C Date:07/13/00ISR Number: 3529310-7Report Type:Expedited (15-DaCompany Report #JRFUSA2000004782 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ovarian Cancer Consumer Risperdal PS Janssen Research Fdn Div Johnson And Johnson ORAL 5 MG, 1 IN 1 DAY(S), ORAL Zyprexa (Olanzapine) C Zoloft (Sertraline Hydrochloride) C Xanax (Alprazolam) C Klonopin (Clonazepam) C Date:07/13/00ISR Number: 3529311-9Report Type:Expedited (15-DaCompany Report #JACGER2000001070 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Hydrocephalus Study Div Johnson And Health Johnson ORAL 0.5 MG, 1 IN Professional 1 DAY(S), ORAL Furosemide (Furosemide) C Bronchoretard (Theophylline) C Ranitidine (Ranitidine) C Acimethin (Methione) C Valoron N (Valoron 22-Feb-2006 08:20 AM Page: 841 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report N) C Zopiclone (Zopiclone) C Date:07/13/00ISR Number: 3529312-0Report Type:Expedited (15-DaCompany Report #JACGER2000001117 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Drug Ineffective Study Div Johnson And Health Johnson ORAL MG, 2 IN 1 Professional DAY(S), ORAL Spasmo-Mucosolvan (Spasmo-Mucosolvan) C Date:07/13/00ISR Number: 3529313-2Report Type:Expedited (15-DaCompany Report #JRFBEL2000001688 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Risperdal PS Janssen Research Fdn Required Cardiac Valve Disease Health Div Johnson And Intervention to Chest X-Ray Abnormal Professional Johnson ORAL MG, DAILY, Prevent Permanent Mental Disorder ORAL Impairment/Damage Pericarditis Impromen (Unspecified) (Bromperidol) SS ORAL MG, DAILY, ORAL Levomepromazine (Levomepromazine) C Akineton (Biperiden Hydrochloride) C Hiberna (Promethazine Hydrochloride) C Resmit (Medazepam) C Halcion (Triazolam) C Pantosin (Panthethine) C Pursennid (Senna Leaf0 C Date:07/13/00ISR Number: 3529314-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000001703 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Oral Intake Reduced Health Div Johnson And Professional Johnson ORAL ORAL Trihexyphenidyl (Trihexyphenidyl) C Vaben (Oxazepam) C Date:07/13/00ISR Number: 3529315-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000000365 Age:82 YR Gender:Male I/FU:F Outcome Death Hospitalization - 22-Feb-2006 08:20 AM Page: 842 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Anaemia Consumer Risperdal PS Janssen Research Fdn Cough Div Johnson And Dysphagia Johnson ORAL 1 MG, 2 IN 1 Dyspnoea DAY(S), ORAL Mental Impairment Pepcid (Famotidine) C Myocardial Infarction Remeron Nasopharyngeal Disorder (Mirtazapine) C Renal Impairment Ativan (Lorazepam) C Salivary Hypersecretion Lisinopril Swelling (Lisinopril) C Trazodone (Trtazodone) C Aspirin (Acetylsalicylic Acid) C Coumadin (Warfarin Sodium) C Prednisone (Prednisone) C Date:07/13/00ISR Number: 3529640-9Report Type:Expedited (15-DaCompany Report #JAOCAN2000000529 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson 3 MG, 2 IN 1 DAY (S) Cogentin C Date:07/14/00ISR Number: 3530133-3Report Type:Expedited (15-DaCompany Report #2000-UK-03982 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Catapres PS Boehringer Ingelheim ORAL NR/0.2 MG Initial or Prolonged Medication Error Health NOCTE/PO 1 MON Priapism Professional Risperdal SS Date:07/14/00ISR Number: 3530134-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000001752 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Risperdal PS Janssen Research Fdn Murder Health Div Johnson And Nervousness Professional Johnson ORAL MG, DAILY, ORAL Date:07/14/00ISR Number: 3530135-7Report Type:Expedited (15-DaCompany Report #JACGBR2000000431 Age:27 YR Gender:Male I/FU:F Outcome PT Hospitalization - Depressed Level Of Initial or Prolonged Consciousness Encephalopathy 22-Feb-2006 08:20 AM Page: 843 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeling Abnormal Head Banging Intentional Self-Injury Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL 0.5 MG, 2 IN 1 DAY, PO; 4 MG, 2 IN 1 DAY, PO; 3.5 MG, 2 IN 1 Droperidol (Droperidol) SS 10 MG, 3 IN 1 DAY(S), Thioridazine (Thioridazine) C Fluoxetine (Fluoxetine) C Gaviscon (Gaviscon / Old Form/ ) C Diazepam (Diazepam) C Date:07/17/00ISR Number: 3529844-5Report Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akathisia Health Zyprexa 10mg PS ORAL 10MG PO QD Tardive Dyskinesia Professional Risperidone SS ORAL 8MG PO QD Effexor C Cogentin C Amantadine C Date:07/17/00ISR Number: 3584787-6Report Type:Periodic Company Report #000627-SK060 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Celebrex PS Gd Searle And Co ORAL PO Anxiety Risperdal SS ORAL 0.750 MG QD Sedation PO Advil SS ORAL PO Motrin SS ORAL PO Propranolol Hydrochloride C Date:07/18/00ISR Number: 3530568-9Report Type:Direct Company Report # Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Health Risperidone 2mg Initial or Prolonged Professional Tablets Janssen PS Janssen ORAL 2 MG BID ORAL Carbamazepine 100 And 200 Mg Tablets Generic SS Generic ORAL 100MG AM NO/ 200 MG HS ORAL Venlafaxine C Gabapentin C Vitamin E C Pyridoxine C 22-Feb-2006 08:20 AM Page: 844 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ... C Date:07/18/00ISR Number: 3530895-5Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Rigidity Risperidone 1mg Initial or Prolonged Abdominal Tenderness (Jansen) PS Janssen ORAL 0.5MG PO HS Hepatitis Liver Function Test Abnormal Pyrexia Date:07/18/00ISR Number: 3531359-5Report Type:Expedited (15-DaCompany Report #JAKYO41864 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Haldol PS Rw Johnson Initial or Prolonged Consciousness Health Pharmaceutical Extrapyramidal Disorder Professional Research Institute Nervous System Disorder Div Ortho Pharm ORAL MG, DAILY, Tardive Dyskinesia ORAL Risperidone (Tablet) (Risperidone) SS ORAL MG, DAILY, ORAL Thioridazine Hydrochloride (Thioridazine) SS ORAL MG, DAILY, ORAL Fluphenazine (Fluphenazine) SS INTRAMUSCULAR 25 MG, 1 IN 4 WEEK(S), IM Haloperidol Decanoate (Injection) (Haloperidol Decanoate) SS Biperiden Hydrochloride (Biperiden Hydrochloride) C Brotizolam (Tablet) (Brotizolam) C Promethazine Hydrochloride (Promethazine) C Clonazepam (Clonazepam) C Date:07/20/00ISR Number: 3532287-1Report Type:Expedited (15-DaCompany Report #240197 Age:47 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Blood Creatine Phosphokinase Increased Blood Creatinine Increased 22-Feb-2006 08:20 AM Page: 845 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Urea Increased Confusional State Delirium Report Source Product Role Manufacturer Route Dose Duration Disorientation Foreign Valium PS Hoffmann La Roche Disturbance In Attention Literature Inc 60 MG DAILY 1826 DAY Drug Abuser Health Meprobamate Drug Withdrawal Syndrome Professional (Meprobamate) SS 2400 MG DAILY 1826 DAY Hallucinations, Mixed Risperidone Heart Rate Irregular (Risperidone) SS 2 MG DAILY 5 DAY Leukocytosis Medication Error Muscle Rigidity Neuroleptic Malignant Syndrome Paranoia Persecutory Delusion Pyrexia Renal Failure Tremor Date:07/21/00ISR Number: 3533531-7Report Type:Expedited (15-DaCompany Report #JRFBEL2000001805 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Brain Scan Abnormal Foreign Risperdal PS Janssen Research Fdn Dementia Literature Div Johnson And Hypersensitivity Health Johnson ORAL MG, DAILY, Nervous System Disorder Professional ORAL 2 WK Citalopram (Citalopram) C Date:07/21/00ISR Number: 3533532-9Report Type:Expedited (15-DaCompany Report #HOAFF36510 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Risperdal PS Janssen Research Fdn Decreased Literature Div Johnson And White Blood Cell Count Health Johnson ORAL 2 MG, 2 IN 1 Decreased Professional DAY, ORAL Methotrimeprazine C Lorazepam C Biperiden(Biperiden) C Date:07/24/00ISR Number: 3533629-3Report Type:Direct Company Report # Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Impairment Risperdal 1mg PS ORAL 1MG BID PO Initial or Prolonged Urinary Tract Infection Felodipine C Lisinoprist C Hydrea C Hctz C Phenytoin C Asa C Prazosin C 22-Feb-2006 08:20 AM Page: 846 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/00ISR Number: 3534245-XReport Type:Expedited (15-DaCompany Report #JACGER2000001178 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal PS Janssen Research Fdn Hospitalization - Drug Ineffective Study Div Johnson And Initial or Prolonged Pneumonia Health Johnson ORAL 0.5 MG, 2 IN Professional 1 DAY(S), ORAL Dipiperon (Pipamperone) C Vitaferro (Kendural C) C Novaminsulfon (Metamizole Sodium) C Date:07/24/00ISR Number: 3534247-3Report Type:Expedited (15-DaCompany Report #JACGER2000001177 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysarthria Foreign Risperdal PS Janssen Research Fdn Transient Ischaemic Study Div Johnson And Attack Health Johnson ORAL MG DAILY Professional ORAL Diclofenac (Diclofenac) C Ass (Acetylsalicylic Acid) C Date:07/24/00ISR Number: 3534248-5Report Type:Expedited (15-DaCompany Report #JACFRA2000000505 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Brain Oedema Health Div Johnson And Required Brain Scan Abnormal Professional Johnson ORAL ORAL Intervention to Convulsion Tegretol Prevent Permanent Depressed Level Of (Carbamazepine) SS ORAL ORAL Impairment/Damage Consciousness Tercian Disorientation (Cyamemazine) C Hyponatraemia Toxicologic Test Normal Date:07/24/00ISR Number: 3534777-4Report Type:Expedited (15-DaCompany Report #JACFRA2000000500 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infectious Mononucleosis Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Neutropenia Health Div Johnson And Professional Johnson ORAL 1 MG, 1 IN DAY(S), ORAL Leponex (Clozapine) C 22-Feb-2006 08:20 AM Page: 847 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/00ISR Number: 3534781-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000005323 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Laryngeal Disorder Consumer Risperdal PS Janssen Research Fdn Required Oral Intake Reduced Div Johnson And Intervention to Starvation Johnson ORAL ORAL Prevent Permanent Weight Decreased Impairment/Damage Date:07/25/00ISR Number: 3534602-1Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Fatigue Risperidone 1mg PS ORAL 1 MG/3 Food Interaction QAM/QPM Sedation ORAL Fluoxetine 40 Mg SS ORAL 40 MG QD ORAL Grapefruit Juice C Date:07/26/00ISR Number: 3536244-0Report Type:Expedited (15-DaCompany Report #2000-UK-03982 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erectile Dysfunction Foreign Catapres PS Boehringer Ingelheim ORAL NR/0.2 MG Initial or Prolonged Priapism Health NOCTE/PO Disability Sedation Professional APPROX 1 MONTH Risperdal SS ORAL 1 MG/PO 2 DAY Ritalin Sr C Ritalin C Date:07/27/00ISR Number: 3536500-6Report Type:Expedited (15-DaCompany Report #JRFBEL2000001864 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Haldol (Unspecified) (Haloperidol) C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Levomepromazine Maleate (Levomepromazine Maleate) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Sultopride Hydrochloride (Sultopride Hydrochloride) C 22-Feb-2006 08:20 AM Page: 848 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/00ISR Number: 3536620-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000005409 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rhabdomyolysis Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL ORAL Date:07/28/00ISR Number: 3537193-4Report Type:Direct Company Report # Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Fall Risperdal PS SEE ITEM B5 Gait Disturbance High Blood Pressure Peripheral Nerve Injury Medication C Upper Limb Fracture Atrovent/Albuterol C Date:07/28/00ISR Number: 3537794-3Report Type:Expedited (15-DaCompany Report #FLUV00300005064 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Foreign Luvox PS Solvay Laboratory Test Abnormal Health Pharmaceuticals ORAL 150 MG DAILY Muscle Rigidity Professional PO Neuroleptic Malignant Other Serenace Syndrome (Haloperidol) SS ORAL 2 MG DAILY PO Pyrexia Risperdal (Risperidone) SS ORAL 1 MG DAILY PO Date:07/31/00ISR Number: 3538243-1Report Type:Expedited (15-DaCompany Report #JRFBEL2000001897 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Idiopathic Foreign Risperdal PS Janssen Research Fdn Hospitalization - Thrombocytopenic Purpura Health Div Johnson And Initial or Prolonged Professional Johnson ORAL ML, DAILY, ORAL Date:07/31/00ISR Number: 3538816-6Report Type:Expedited (15-DaCompany Report #JACGBR2000000458 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Priapism Health Div Johnson And Disability Sedation Professional Johnson ORAL 1 MG, 1 IN 1 Required DAY(S), ORAL Intervention to Ritalin Sr Prevent Permanent (Methilphenidate Impairment/Damage Hydrochloride) SS 20 MG , 1 IN 1 DAY(S), 10 MG , 3 IN 1 DAY(S) Clonidine C 22-Feb-2006 08:20 AM Page: 849 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/00ISR Number: 3538820-8Report Type:Expedited (15-DaCompany Report #JRFUSA2000005502 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Company Johnson Representative Date:07/31/00ISR Number: 3538829-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000001864 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal PS Janssen Research Fdn Condition Aggravated Health Div Johnson And Hallucination, Auditory Professional Johnson ORAL MG, DAILY, Impulse-Control Disorder ORAL Insomnia Haldol C Chlorpromazine Hydrochloride C Levomepromazine C Biperiden C Sultopride Hydrochloride C Date:07/31/00ISR Number: 3538830-0Report Type:Expedited (15-DaCompany Report #JRFUSA2000002933 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Risperdal PS Janssen Research Fdn Initial or Prolonged Anticholinergic Syndrome Professional Div Johnson And Diarrhoea Johnson ORAL 3 MG, 2 IN Erythropenia DAY(S), ORAL Hypotension SEE IMAGE Leukopenia Clozaril SS ORAL ORAL Thrombocytopenia Paroxetine SS ORAL ORAL Vomiting Haldol (Tablet) Loperidol C Date:07/31/00ISR Number: 3539468-1Report Type:Expedited (15-DaCompany Report #JAOCAN2000000615 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Cancer Female Foreign Risperdal PS Janssen Research Fdn Galactorrhoea Health Div Johnson And Hyperprolactinaemia Professional Johnson ORAL ORAL Company Representative Other Date:08/01/00ISR Number: 3538344-8Report Type:Expedited (15-DaCompany Report #2000AP03521 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chorea Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 200 MG BID PO Initial or Prolonged Drug Interaction Health Risperdal SS ORAL 8 MG DAILY PO Tardive Dyskinesia Professional Artane C Other Valium C 22-Feb-2006 08:20 AM Page: 850 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/00ISR Number: 3540132-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000001899 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aplastic Anaemia Foreign Risperdal PS Janssen Research Fdn Hospitalization - Bone Marrow Transplant Health Div Johnson And Initial or Prolonged Haemoglobin Decreased Professional Johnson ORAL 8 MG, 1 IN 1 Required Spinal Cord Injury NIGHT(S), Intervention to Syncope ORAL Prevent Permanent Lamictin Impairment/Damage (Lamotrigine) SS ORAL 200 MG, 2 IN 1 DAY (S), ORAL Voltaren (Diclofenac Sodium) SS Date:08/02/00ISR Number: 3540133-5Report Type:Expedited (15-DaCompany Report #JACGBR2000000519 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL 4 MG, 1 IN 1 DAILY, ORAL Atenolol (Atenolol) C Droleptan (Unspecified) (Droperidol) C Diazepam (Diazepam) C Date:08/02/00ISR Number: 3540134-7Report Type:Expedited (15-DaCompany Report #JRFUSA1999001672 Age:73 YR Gender:Female I/FU:F Outcome PT Death Abdominal Pain Hospitalization - Anaemia Initial or Prolonged Arthralgia Required Back Pain Intervention to Dehydration Prevent Permanent Depressed Level Of Impairment/Damage Consciousness Depression Diarrhoea Duodenal Ulcer Ecchymosis Embolism Escherichia Infection Gastrointestinal Haemorrhage Hallucination Hypotension Myalgia Nausea Parkinson'S Disease Pneumonia Rectal Haemorrhage Tachypnoea Tardive Dyskinesia Tremor Urinary Incontinence 22-Feb-2006 08:20 AM Page: 851 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Urinary Tract Infection Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal PS Janssen Research Fdn Div Johnson And Johnson ORAL 1 MG, 1 IN1 DAY (S), ORAL Duragesic (Patch) (Fentanyl) SS TRANSDERMAL TRANSD Naprosyn (Naproxen) SS ORAL 500 MG, 2 IN1 , DAY (S), ORAL Ibuprofen (Ibuprofen) SS ORAL PRN, ORAL Prednisone (Prednisone) SS ORAL ORAL Tylenol (Paracetamol) C Claritin (Sinemet) C Synthroid (Levothyroxine Sodium) C Zoloft (Sertraline Hydrochloride) C Restoril (Temazepam) C Ventolin (Salbutamol) C Atrovent (Ipratropium Bromide) C Lorazepam (Lorazepam) C Ceftin (Cefuroxime Sodium) C Sinemet C Date:08/02/00ISR Number: 3540135-9Report Type:Expedited (15-DaCompany Report #JAKYO33736 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal PS Janssen Research Fdn Influenza Health Div Johnson And Respiratory Failure Professional Johnson ORAL MG, DAILY, ORAL Cisapride (Unspecified) (Cisapride) C Clothiazepam (Clothiazepam) C Mexazolam (Mexazolam) C Flunitrazepam (Flunitrazepam) C Pirenzepine (Pirenzepine) C Cetraxate Hydrochloride (Cetraxate Hydrochloride) C 22-Feb-2006 08:20 AM Page: 852 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/00ISR Number: 3540141-4Report Type:Expedited (15-DaCompany Report #JRFUSA2000005503 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Disorder Health Risperdal PS Janssen Research Fdn Initial or Prolonged Professional Div Johnson And Johnson ORAL ORAL Date:08/03/00ISR Number: 3541462-1Report Type:Expedited (15-DaCompany Report #JRFBEL2000001596 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Haldol PS Rw Johnson Hospitalization - Delusion Health Pharmaceutical Initial or Prolonged Dystonia Professional Research Institute Hallucination, Auditory Div Ortho Pharm ORAL ORAL Malaise Risperidone (Tablet) Pain (Risperidone) SS ORAL MG, DAILY, Schizophrenia ORAL Speech Disorder Zotepine (Zotepine) SS ORAL MG, DAILY, Suicidal Ideation ORAL Tongue Disorder Tiapride Hydrochloride (Tiapride Hydrochloride) C Levomepromazine Maleate (Levomepromazine Maleate) C Lorazepam (Lorazepam) C Biperiden Hydrochloride (Biperiden Hydrochloride ) C Tocopherol Acetate (Tocopherol) C Flunitrazepam (Flunitrazepam) C Date:08/04/00ISR Number: 3542765-7Report Type:Expedited (15-DaCompany Report #PHBS2000GB03226 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Foreign Mellaril PS Novartis Therapeutic Health Pharmaceuticals Corp ORAL 100 MG, QID, Professional ORAL Other Risperidone (Risperidone) SS ORAL SEE IMAGE Sertraline (Sertraline) SS Omeprazole (Omeprazole) C Zopiclone C 22-Feb-2006 08:20 AM Page: 853 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/00ISR Number: 3544258-XReport Type:Expedited (15-DaCompany Report #00P-062-0095688-00 (0) Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Depakene PS Abbott Laboratories Initial or Prolonged Coordination Abnormal Literature Pharmaceutical Depressed Level Of Health Products Div ORAL 600 MG, 1 IN Consciousness Professional 1 D, PER ORAL Disorientation Doxepin (Doxepin) SS ORAL 200 MG, 1 IN Drug Interaction 1 D, PER ORAL Drug Level Above Risperidone Therapeutic (Risperidone) SS ORAL 4 MG, 1 IN 1 Electroencephalogram D, PER ORAL Abnormal Biperiden Encephalopathy (Biperiden) SS ORAL 4 MG, 1 IN 1 Fatigue D, PER ORAL Sedation Lorazepam Tremor (Lorazepam) C Date:08/07/00ISR Number: 3544759-4Report Type:Expedited (15-DaCompany Report #JRFUSA2000000095 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Risperdal PS Janssen Research Fdn Initial or Prolonged Akathisia Professional Div Johnson And Required Amnesia Johnson ORAL 3 MG, 2 IN 1 Intervention to Angina Pectoris DAY (S), ORAL Prevent Permanent Arthralgia (SEE IMAGE) Impairment/Damage Asthenia Haldol (Tablet) Bradykinesia (Haloperidol) SS ORAL 2 MG, 4 IN 1 Cardiac Arrest DAY (S), ORAL Chest Pain Ativan (Lorazepam) SS ORAL 2 MG, 4 IN 1 Difficulty In Walking DAY (S), ORAL Drug Withdrawal Syndrome Olanzapine C Dyskinesia Seroquel C Feeling Cold Headache Heart Rate Increased Joint Stiffness Malaise Overdose Parkinsonism Psychotic Disorder Pulse Absent Restlessness Sleep Disorder Tachycardia Tardive Dyskinesia Tremor Weight Decreased Date:08/07/00ISR Number: 3544787-9Report Type:Expedited (15-DaCompany Report #JRFUSA2000004283 Age:92 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Consumer Risperdal PS Janssen Research Fdn Coordination Abnormal Health Div Johnson And Decreased Activity Professional Johnson ORAL 2 IN 1 DAY Dysphagia (S), ORAL Speech Disorder Antihypertensives C 22-Feb-2006 08:20 AM Page: 854 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/00ISR Number: 3544790-9Report Type:Expedited (15-DaCompany Report #JRFUSA2000005758 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Risperdal PS Janssen Research Fdn Leukopenia Professional Div Johnson And Lymphocytosis Johnson ORAL 3 MG, 2 IN 1 Neutropenia DAY (S), ORAL Remeron C Date:08/07/00ISR Number: 3544793-4Report Type:Expedited (15-DaCompany Report #JRFUSA2000005744 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Laboratory Test Abnormal Company Risperdal PS Janssen Research Fdn Initial or Prolonged Overdose Representative Div Johnson And Renal Failure Johnson ORAL 90 MG, 1 IN 1 TIME (S), ORAL Effexor (Venlafaxine Hydrochloride) SS ORAL ORAL Date:08/09/00ISR Number: 3546634-8Report Type:Expedited (15-DaCompany Report #JACGER2000001249 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL DAILY, ORAL (SEE IMAGE) Diazepam C Date:08/09/00ISR Number: 3546705-6Report Type:Expedited (15-DaCompany Report #JACGBR2000000534 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Health Div Johnson And Professional Johnson ORAL SEE IMAGE Thioridazine (Thioridazine) SS ORAL 25 MG, 3 IN 1 DAY(S), ORAL Date:08/09/00ISR Number: 3546706-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000001938 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Risperdal PS Janssen Research Fdn Complete Consumer Div Johnson And Bradycardia Johnson 0.25 MG , 1 Dyspnoea IN 1 DAY(S), 5 WK Electrocardiogram Qt Zoloft (Sertraline Corrected Interval Hydrochloride) C Prolonged 22-Feb-2006 08:20 AM Page: 855 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/00ISR Number: 3546708-1Report Type:Expedited (15-DaCompany Report #JRFBEL2000001926 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Drug Interaction Health Div Johnson And Hyperhidrosis Professional Johnson ORAL 4 MG, 1 IN 1 Muscle Rigidity DAY(S), ORAL Neuroleptic Malignant Cipramil Syndrome (Citalopram) SS ORAL 20 MG, 1 IN 1 Pallor DAY(S), ORAL Pyrexia Captoprilium Staring (Captopril) C Tremor Oxazepam (Oxazepam) C Temazepamum (Temazepam) C Thiamini Hcl (Thiamine Hydrochloride) C Date:08/10/00ISR Number: 3547876-8Report Type:Expedited (15-DaCompany Report #JRFUSA2000000095 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Haldol PS Rw Johnson Initial or Prolonged Akathisia Professional Pharmaceutical Required Arthralgia Research Institute Intervention to Asthenia Div Ortho Pharm ORAL 2 MG, 4 IN 1 Prevent Permanent Bradykinesia DAY(S), ORAL Impairment/Damage Cardiac Arrest Risperdal (Tablet) Cardio-Respiratory Arrest (Risperidone) SS ORAL 3 MG, 2 IN 1 Chest Pain DAY(S), ORAL Difficulty In Walking Ativan (Lorazepam) SS ORAL 2 MG, 4 IN 1 Drug Effect Decreased DAY(S), ORAL Drug Withdrawal Syndrome Risperdal (Tablet) Headache (Risperidone) SS ORAL 7 MG, DAILY, Heart Rate Increased ORAL Leukopenia Risperdal (Tablet) Malaise (Risperidone) SS ORAL 7.5 MG, Memory Impairment DAILY, ORAL Muscle Rigidity Risperdal (Tablet) Overdose (Risperdone) SS ORAL 1.5 MG, 4 IN Parkinsonism 1 DAY(S), Peripheral Coldness ORAL Pulse Absent Risperdal (Tablet) Red Blood Cell Count (Risperidone) SS ORAL 8.5 MG, Decreased DAILY, ORAL Restlessness Risperdal (Tablet) Sleep Disorder (Risperidone) SS ORAL 6 MG, DAILY, Tachycardia ORAL Tardive Dyskinesia Olanzapine Tremor (Olanzapine) C Weight Decreased Seroquel (Seroquel) C White Blood Cell Count Decreased 22-Feb-2006 08:20 AM Page: 856 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/14/00ISR Number: 3550017-4Report Type:Expedited (15-DaCompany Report #PHBS2000AU04453 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Lamisil PS Novartis Drug Effect Decreased Health Pharmaceuticals Corp ORAL 250 MG, QD, Drug Interaction Professional ORAL Psychotic Disorder Other Risperidone (Risperidone) SS 2 MG, QD; 3 MG, QD Date:08/15/00ISR Number: 3551198-9Report Type:Expedited (15-DaCompany Report #DEU003149 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Foreign Akineton PS Knoll Pharmaceutical Initial or Prolonged Face Oedema Health Co ORAL 4 MG PO Hypersensitivity Professional Risperdal SS ORAL 6 MG PO Oedema Peripheral Other Truxal SS ORAL 100 MG PO Pruritus Skin Test Positive Tachycardia Urticaria Date:08/16/00ISR Number: 3551454-4Report Type:Expedited (15-DaCompany Report #JRFUSA2000001777 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Risperdal PS Janssen Research Fdn Initial or Prolonged Asthenia Health Div Johnson And Required Blood Creatinine Professional Johnson ORAL 1 MG, 1 IN 1 Intervention to Increased DAY (S) , Prevent Permanent Blood Potassium Increased ORAL Impairment/Damage Blood Urea Increased Prozac (Fluoxetine Condition Aggravated Hydrochloride) SS ORAL ORAL Dehydration Difficulty In Walking Haematuria Insomnia Malaise Nausea Pneumonia Red Blood Cell Count Increased Renal Failure Acute White Blood Cell Count Increased Date:08/16/00ISR Number: 3551455-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000005786 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypernatraemia Health Risperdal PS Janssen Research Fdn Initial or Prolonged Professional Div Johnson And Company Johnson ORAL PO Representative 22-Feb-2006 08:20 AM Page: 857 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/16/00ISR Number: 3551502-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000006051 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Consumer Risperdal PS Janssen Research Fdn Div Johnson And Johnson ORAL 2 MG, 2 IN 1 DAY (S), ORAL Date:08/16/00ISR Number: 3551504-5Report Type:Expedited (15-DaCompany Report #JACFRA2000000536 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Fall Health Div Johnson And Hallucination Professional Johnson ORAL 2 MG, DAILY, Orthostatic Hypotension ORAL Norset (Mirtazapine) SS ORAL DAILY, ORAL Exelon (Rivastigmine) C Cordarone (Amiodarone Hydrochloride) C Triatec (Ramipril) C Permixon (Serenoa Repens) C Elisor (Pravastatin Sodium) C Diffu K (Potassium Chloride) C Digoxine (Digoxin) C Naftilux (Naftidrofuryl Oxalate) C Date:08/16/00ISR Number: 3551506-9Report Type:Expedited (15-DaCompany Report #JRFUSA2000006048 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration International Normalised Health Risperdal PS Janssen Research Fdn Ratio Increased Professional Div Johnson And Johnson ORAL ORAL Coumadin (Warfarin Sodium) SS ORAL ORAL Date:08/17/00ISR Number: 3552234-6Report Type:Direct Company Report # Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Health Risperidal PS 1 GM QHS Intervention to Professional Prevent Permanent Impairment/Damage 22-Feb-2006 08:20 AM Page: 858 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/00ISR Number: 3552263-2Report Type:Direct Company Report # Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Health Haldol PS INTRAVENOUS IV PRN; TOTAL Abnormal Professional DOSE 97.5 MG Electrocardiogram Qt Respiridone SS 4 MG QD Prolonged Torsade De Pointes Date:08/18/00ISR Number: 3589007-4Report Type:Periodic Company Report #S99-USA-02348-01 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Health Celexa PS Forest Laboratories Blood Prolactin Increased Professional Inc ORAL 20 MG QD PO Depression Company Celexa (Citalopram) SS 20 MG QD PO Diarrhoea Representative Risperdal Muscle Twitching (Risperidone) SS Paranoia Zyprexa (Olanzapine) SS ORAL 2.5 MG PRN PO Sedation Caffeine SS Sinusitis Lithium Carbonate C Ambien (Zolpidem Tartrate) C Date:08/18/00ISR Number: 3591374-2Report Type:Periodic Company Report #S00-USA-00444-01 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Health Celexa PS Forest Laboratories Drug Interaction Professional Inc ORAL 40 MG QD PO Celexa (Citalopram) SS ORAL 20 MG QD PO Celexa (Citaloprame) SS ORAL 20 MG QD PO Risperdal (Risperidone) SS ORAL 3 MG QD PO Risperdal (Risperidone) SS ORAL 6 MG QD PO Date:08/21/00ISR Number: 3554929-7Report Type:Expedited (15-DaCompany Report #JRFUSA2000006106 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ammonia Increased Health Risperdal PS Janssen Research Fdn Hospitalization - Blood Creatinine Professional Div Johnson And Initial or Prolonged Increased Johnson ORAL 0.5 MG, 2 IN Required Coma 2 DAY(S), Intervention to Confusional State ORAL; 0.5 MG, Prevent Permanent Cor Pulmonale 1 IN 1 Impairment/Damage Coronary Artery Disease DAY(S), ORAL Hallucination Hepatic Failure Hepatorenal Syndrome Mental Impairment Oliguria Renal Failure Renal Impairment 22-Feb-2006 08:20 AM Page: 859 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/21/00ISR Number: 3554932-7Report Type:Expedited (15-DaCompany Report #JACGER2000001352 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Second Degree Health Div Johnson And Cardiac Arrest Professional Johnson ORAL MG, DAILY, Sinus Arrest ORAL Haldol (Haloperidol) SS ORAL DAILY, ORAL Zyprexa (Olanzapine) SS ORAL DAILY, ORAL Eunerpan (Melperone Hydrochloride) SS ORAL MG, DAILY, ORAL Date:08/21/00ISR Number: 3554935-2Report Type:Expedited (15-DaCompany Report #JACGBR2000000584 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Encephalopathy Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL ORAL Date:08/22/00ISR Number: 3555291-6Report Type:Expedited (15-DaCompany Report #JACGER2000001352 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Haldol PS Rw Johnson Initial or Prolonged Sinus Arrest Health Pharmaceutical Professional Research Institute Div Ortho Pharm ORAL DAILY ORAL Risperdal (Tablet) (Risperidone) SS ORAL DAILY, ORAL Zyprexa (Olanzapine) SS ORAL DAILY, ORAL Eunerpan (Melperone Hydrochloride0 SS ORAL DAILY, ORAL Date:08/22/00ISR Number: 3555928-1Report Type:Expedited (15-DaCompany Report #S00-GER-00965-01 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Citalopram PS Forest Laboratories Initial or Prolonged Cough Health Inc ORAL 20 MG QD PO Dysphagia Professional Cipramil (Citalopram Hypokinesia Other Hydrobromide) SS ORAL 40 MG QD PO Pyrexia Cipramil (Citalopram Speech Disorder Hydrobromide) SS 60 MG QD NG Tachypnoea Cipramil (Citalopram Tongue Disorder Hydrobromide) SS 50 MG QD NG Trismus Risperdal (Risperidone) SS ORAL 6 MG QD PO Risperdal (Risperidone) SS ORAL 8 MG QD PO Risperdal (Risperidone) SS ORAL 6 MG QD PO Risperdal (Risperidone) SS ORAL 8 MG QD PO Risperdal (Risperidone) SS 6 MG QD NG 22-Feb-2006 08:20 AM Page: 860 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Saroten C Tavor C Date:08/23/00ISR Number: 3556372-3Report Type:Direct Company Report # Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Risperidone PS ORAL 5MG PO QHS Date:08/23/00ISR Number: 3556462-5Report Type:Expedited (15-DaCompany Report #S00-NLD-01228-00 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Celexa PS Forest Laboratories Initial or Prolonged Drug Interaction Health Inc ORAL 20 MG QD PO Hyperhidrosis Professional Risperdal Muscle Rigidity Other (Risperidone) SS ORAL 4 MG QD PO Neuroleptic Malignant Oxazepam C Syndrome Temazepam C Pallor Thiamine Pyrexia Hydrochloride C Staring Captoprilum Tremor (Captopril) C Date:08/24/00ISR Number: 3557500-6Report Type:Expedited (15-DaCompany Report #JAOCAN2000000707 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Syncope Health Div Johnson And Professional Johnson ORAL 0.25 MG 1 IN Company 1 TIME (S), Representative ORAL Date:08/24/00ISR Number: 3557503-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000006104 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heat Stroke Health Risperdal PS Janssen Research Fdn Initial or Prolonged Hyperpyrexia Professional Div Johnson And Johnson ORAL 5.5 MG, 1 DAILY ORAL Valproic Acid (Valproic Acid) C Clonazepam (Clonazepam) C Benztropine (Benztropine) C Diphenhydramine (Diphenhydramine) C Vitamin E (Tocopherol) C Vitamin C (Ascorbic Acid) C 22-Feb-2006 08:20 AM Page: 861 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/24/00ISR Number: 3557647-4Report Type:Expedited (15-DaCompany Report #JACGER2000001329 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Foreign Risperdal PS Janssen Research Fdn Cardiac Failure Study Div Johnson And Health Johnson ORAL MG, DAILY, Professional ORAL Mianserin (Mianserin) C Temazepam (Temazepam) C Date:08/24/00ISR Number: 3557786-8Report Type:Expedited (15-DaCompany Report #JRFUSA2000006211 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Petechiae Consumer Risperdal PS Janssen Research Fdn Platelet Count Abnormal Div Johnson And Johnson ORAL 1.5 MG, 2 IN 1 DAY(S), ORAL Cogentin C Paxil C Date:08/24/00ISR Number: 3557789-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000006275 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiomyopathy Health Risperdal PS Janssen Research Fdn Condition Aggravated Professional Div Johnson And Johnson ORAL ORAL Date:08/24/00ISR Number: 3557791-1Report Type:Expedited (15-DaCompany Report #JACFRA2000000500 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Health Div Johnson And Professional Johnson ORAL 1 MG, 1 IN 1 DAY(S), ORAL; SEE IMAGE Leponex C Depakine Chrono C Chrono C Date:08/24/00ISR Number: 3557793-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000001981 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatorenal Failure Foreign Risperdal PS Janssen Research Fdn Hospitalization - Sedation Health Div Johnson And Initial or Prolonged Professional Johnson ORAL MG, DAILY, ORAL 1 YR Trileptal C 22-Feb-2006 08:20 AM Page: 862 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/24/00ISR Number: 3557797-2Report Type:Expedited (15-DaCompany Report #JRFUSA2000005503 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Neoplasm Malignant Health Risperdal PS Janssen Research Fdn Initial or Prolonged Respiratory Disorder Professional Div Johnson And Johnson ORAL ORAL Date:08/25/00ISR Number: 3559139-5Report Type:Expedited (15-DaCompany Report #JACGER2000001367 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Femoral Neck Fracture Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Pulmonary Embolism Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Mono-Embolex (Heparin-Fraction, Sodium Salt) SS SUBCUTANEOUS ML, DAILY, SUBCU Date:08/25/00ISR Number: 3559234-0Report Type:Expedited (15-DaCompany Report #JACGER2000001373 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paralysis Foreign Risperdal PS Janssen Research Fdn Study Div Johnson And Health Johnson ORAL 0.5 MG , 1 IN Professional 1 DAY(S) ORAL Koffein (Caffeine) C Insuman Comb (Insuman) C Acerbon (Lisinopril) C Aquaphor (Aquaphor) C Hypericum (Hypericum Extract) C Date:08/25/00ISR Number: 3559242-XReport Type:Expedited (15-DaCompany Report #JAKYO33859 Age:61 YR Gender:Female I/FU:I Outcome PT Other Anaemia Blood Alkaline Phosphatase Increased Blood Creatine Phosphokinase Increased Blood Potassium Decreased Decreased Appetite Differential White Blood Cell Count Abnormal Dizziness Fatigue Haematocrit Decreased Haemoglobin Decreased Lymphopenia Red Blood Cell Count Decreased Tremor Weight Decreased 22-Feb-2006 08:20 AM Page: 863 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Ubidecarenone (Ubidecarenone) C Trapidil (Trapidil) C Estazolam (Estazolam) C Sennosides (Tablet) (Sennosides) C Sodium Picosulfate (Solution) (Sodium Picosulfate) C Peroretard (Tablet) (Ferrous Sulfate) C Folic Acid (Tablet) (Folic Acid) C Date:08/25/00ISR Number: 3559250-9Report Type:Expedited (15-DaCompany Report #JRFBEL2000002066 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Risperdal PS Janssen Research Fdn Biopsy Bone Marrow Literature Div Johnson And Abnormal Health Johnson MG, DAILY Leukopenia Professional Clozapine Neutropenia (Clozapine) SS Date:08/25/00ISR Number: 3559254-6Report Type:Expedited (15-DaCompany Report #JACFRA2000000478 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL 2 MG, 6 IN 1 WEEK(S), ORAL Temesta (Lorazepam) C Stilnox (Zolpidem) C Euphytose (Euphytose) C Date:08/25/00ISR Number: 3559264-9Report Type:Expedited (15-DaCompany Report #JACGBR2000000339 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal PS Janssen Research Fdn Required Cardio-Respiratory Arrest Health Div Johnson And Intervention to Respiratory Arrest Professional Johnson ORAL SEE IMAGE Prevent Permanent Respiratory Failure Sulpiride Impairment/Damage Sudden Death (Sulpiride) SS ORAL 2400 MG, DAILY, ORAL Clozapine (Clozapine) SS ORAL 700, DAILY,ORAL 22-Feb-2006 08:20 AM Page: 864 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Procyclidine (Procyclidine) SS ORAL 15 MG, ORAL Droleptan (Unspecified) (Droperidol) C Lorazepam (Lorazepam) C Date:08/28/00ISR Number: 3559602-7Report Type:Direct Company Report # Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Depakote PS Eye Movement Disorder Risperidone SS Speech Disorder Tic Tongue Disorder Weight Decreased Date:08/28/00ISR Number: 3559640-4Report Type:Direct Company Report # Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Risperidone PS Aggression Disorientation Drug Abuser Headache Hyperplasia Hyperprolactinaemia Hypertension Hypothalamo-Pituitary Disorders Irritability Medication Error Vision Blurred Date:08/28/00ISR Number: 3560236-9Report Type:Expedited (15-DaCompany Report #JRFUSA2000002006 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Health Risperdal PS Janssen Research Fdn Initial or Prolonged Leukopenia Professional Div Johnson And Required Neutropenia Johnson ORAL 2 MG, 1 IN 1 Intervention to Pyrexia NIGHT(S), Prevent Permanent Thrombocytopenia ORAL; 3 MG, 1 Impairment/Damage IN 1 NIGHT(S), Date:08/28/00ISR Number: 3560466-6Report Type:Expedited (15-DaCompany Report #JACGBR2000000553 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson 3 MG, DAILY Modurectic 22-Feb-2006 08:20 AM Page: 865 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Moduretic) C Exelon (Rivastigmine) C Date:08/28/00ISR Number: 3560486-1Report Type:Expedited (15-DaCompany Report #JACFRA2000000533 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Confusional State Health Div Johnson And Disorientation Professional Johnson ORAL 12 MG, DAILY, Sedation ORAL Imovane (Zoplicone) SS ORAL 7.5 MG, DAILY, ORAL Nozinan (Levomepromazine) SS ORAL ORAL Prozac (Fluoxetine Hydrochloride) SS ORAL 20 MG, DAILY, ORAL Tranxene (Clorazepate Dipotassium) SS ORAL 200 MG, DAILY, ORAL Date:08/28/00ISR Number: 3560520-9Report Type:Expedited (15-DaCompany Report #JRFBEL2000001974 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Literature Risperdal PS Janssen Research Fdn Exposure To Therapeutic Health Div Johnson And Drugs Professional Johnson Intra-Uterine Death Olanzapine (Olanzapine) SS Date:08/28/00ISR Number: 3560521-0Report Type:Expedited (15-DaCompany Report #JRFBEL2000001981 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Foreign Risperdal PS Janssen Research Fdn Hospitalization - Renal Failure Health Div Johnson And Initial or Prolonged Sedation Professional Johnson ORAL MG, DAILY, ORAL 1 YR Tegretol (Carbamazepine) C Date:08/28/00ISR Number: 3560522-2Report Type:Expedited (15-DaCompany Report #JACFRA2000000459 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Exposure To Therapeutic Health Div Johnson And Drugs Professional Johnson ORAL 2 MG, 1 IN 1 Drug Withdrawal Syndrome DAY(S), ORAL Neonatal Tercian (Cyamemazine) SS ORAL MG, DAILY, ORAL Methadone (Methadone) SS ORAL 70 MG, 1 IN 1 22-Feb-2006 08:20 AM Page: 866 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY(S), ORAL Methadone (Methadone) SS UTERINE Date:08/28/00ISR Number: 3560524-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000003302 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Risperdal PS Janssen Research Fdn Initial or Prolonged Blood Creatine Professional Div Johnson And Phosphokinase Increased Johnson ORAL 1 MG, 2 IN 1 Hyperglycaemia DAY(S), ORAL Hypermagnesaemia Hyperthermia Malignant Hypokalaemia Mental Impairment Metabolic Acidosis Neuroleptic Malignant Syndrome Date:08/31/00ISR Number: 3563243-5Report Type:Expedited (15-DaCompany Report #DEU003391 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Conduction Disorder Foreign Akineton PS Knoll Pharmaceutical Initial or Prolonged Health Co ORAL 4 MG PO Professional Haldol SS ORAL 5 MG PO Other Risperdal SS ORAL 2 MG PO Date:09/01/00ISR Number: 3564158-9Report Type:Expedited (15-DaCompany Report #JACFRA2000000559 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Withdrawal Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Syndrome Health Div Johnson And Blood Creatine Professional Johnson ORAL 5 MG, DAILY, Phosphokinase Increased ORAL Hallucination Topalgic (Tramadol Muscle Rigidity Hydrochloride) C Neuroleptic Malignant Depamide Syndrome (Valpromide) C Tachycardia Myolastan (Tetrazepam) C Loxapac (Loxapine Succinate) C Floxyfral (Fluvoxamine Maleate) C Cozzar (Losartan Potassium) C Date:09/01/00ISR Number: 3564159-0Report Type:Expedited (15-DaCompany Report #JRFUSA2000005758 Age:58 YR Gender:Female I/FU:F Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:20 AM Page: 867 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Health Risperdal PS Janssen Research Fdn Leukopenia Professional Div Johnson And Lymphocytosis Johnson ORAL 6 MG, 1 IN 1 Neutropenia DAY (S), ORAL Remeron (Mirtazapine) C Date:09/01/00ISR Number: 3564160-7Report Type:Expedited (15-DaCompany Report #JRFUSA2000006749 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen Research Fdn Initial or Prolonged Hallucination, Auditory Div Johnson And Insomnia Johnson ORAL ORAL Date:09/01/00ISR Number: 3564161-9Report Type:Expedited (15-DaCompany Report #JRFBEL2000002116 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nephritis Interstitial Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson Date:09/01/00ISR Number: 3564191-7Report Type:Expedited (15-DaCompany Report #JRFBEL2000002104 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Convulsion Foreign Risperdal PS Janssen Research Fdn Electroencephalogram Health Div Johnson And Abnormal Professional Johnson ORAL MG, DAILY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Haloperidol (Haloperdiol) C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Amezinium Metilsulfate (Amezinium Metilsulfate) C Date:09/02/00ISR Number: 3564073-0Report Type:Expedited (15-DaCompany Report #FLUV00300005064 Age:67 YR Gender:Female I/FU:F Outcome PT Hospitalization - Hyperhidrosis Initial or Prolonged Muscle Rigidity Neuroleptic Malignant Syndrome 22-Feb-2006 08:20 AM Page: 868 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Report Source Product Role Manufacturer Route Dose Duration Foreign Luvox PS Solvay Health Pharmaceuticals ORAL 150 MG DAILY Professional PO Other Serenace (Haloperidol) SS ORAL 2 MG DAILY PO Risperdal (Risperidone) SS ORAL 1 MG DAILY PO Date:09/06/00ISR Number: 3566401-9Report Type:Expedited (15-DaCompany Report #JRFUSA1999001672 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Consumer Risperdal PS Janssen Research Fdn Hospitalization - Anaemia Div Johnson And Initial or Prolonged Arthralgia Johnson ORAL 1 MG, 1 IN 1 Required Back Pain DAY(S), ORAL; Intervention to Dehydration 2 IN 1 DAY Prevent Permanent Dementia Duragesic (Patch) Impairment/Damage Depressed Level Of (Fentanyl) SS TRANSDERMAL TRANSD Consciousness Naprosyn (Naproxen) SS ORAL 500 MG, 2 IN Depression 1 DAY(S), Diarrhoea ORAL Drooling Ibuprofen Duodenal Ulcer (Ibuprofen) SS ORAL PRN, ORAL Ecchymosis Prednisone Escherichia Infection (Prednisone) SS ORAL ORAL Gastrointestinal Tylenol Haemorrhage (Paracetamol) C Haematemesis Claritin Hallucinations, Mixed (Loratadine) C Hiatus Hernia Sinemet (Sinemet) C Hypotension Synthroid Malformation Venous (Levothyroxine) C Myalgia Zoloft (Sertraline Nausea Hydrochloride) C Parkinson'S Disease Restoril (Temazepam) C Pneumonia Ventolin Rectal Haemorrhage (Salbutamol) C Respiratory Disorder Atrovent Respiratory Rate (Ipratropium) C Increased Lorazepam Schizophrenia (Lorazepam) C Tardive Dyskinesia Ceftin (Cefuroxime Tremor Axetil) C Urinary Incontinence Urinary Tract Infection Date:09/06/00ISR Number: 3566532-3Report Type:Expedited (15-DaCompany Report #JAOCAN2000000825 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Increased Health Div Johnson And Professional Johnson ORAL 0.5 MG, 1 IN 1 NIGHT(S), 22-Feb-2006 08:20 AM Page: 869 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL 1 YR Laxatives (Laxatives) C Date:09/06/00ISR Number: 3566533-5Report Type:Expedited (15-DaCompany Report #JACGBR2000000339 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal PS Janssen Research Fdn Required Cardio-Respiratory Arrest Health Div Johnson And Intervention to Circulatory Collapse Professional Johnson Prevent Permanent Loss Of Consciousness Sulpiride Impairment/Damage Respiratory Failure (Sulpiride) SS ORAL 2400 MG, DAILY, ORAL Clozapine (Clozapine SS ORAL 700 , DAILY, ORAL Procyclidine (Procyclidine) SS ORAL 15 MG, ORAL Droleptan (Droperidol) C Lorazepam (Lorazepam) C Date:09/07/00ISR Number: 3566477-9Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperdal 3mg Non-Insulin-Dependent (Janssen) PS Janssen ORAL 3MG PO QHS Remeron C Paxil C Prilosec C Dilantin C Tylenol C Multiple Vitamins C Maalox C Date:09/08/00ISR Number: 3568251-6Report Type:Direct Company Report # Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dry Mouth Risperidone 2mg And Initial or Prolonged Dyskinesia 4mg PS Janssen ORAL 2MG/4MG AM/HS Other Muscle Spasms ORAL Speech Disorder Fluvoxamine 100mg Tablet Upjohn SS Upjohn ORAL 100MG BID ORAL Dexedrine Sr C Synthroid C Clonidine C Lithium C Date:09/08/00ISR Number: 3568467-9Report Type:Expedited (15-DaCompany Report #JACFRA2000000478 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Other Leukopenia Foreign Neutropenia Health 22-Feb-2006 08:20 AM Page: 870 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal PS Janssen Research Fdn Div Johnson And Johnson ORAL 2 MG, 6 IN 1 WEEK(S), ORAL Temesta (Lorazepam) C Stilnox (Zolpidem) C Euphytose (Euphytose) C Date:09/08/00ISR Number: 3568803-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000002116 Age:66 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephritis Interstitial Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Health Div Johnson And Professional Johnson MG, DAILY, Date:09/08/00ISR Number: 3568804-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000002104 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Circadian Rhythm Sleep Foreign Risperdal PS Janssen Research Fdn Disorder Health Div Johnson And Circulatory Collapse Professional Johnson ORAL MG, DAILY, Convulsion ORAL Electroencephalogram Biperiden Abnormal Hydrochloride C Fatigue Haloperidol C Grand Mal Convulsion Chlorpromaxine Headache Hydrochloride C Listless Amezinium Malaise Metilsulfate C Suicidal Ideation Flunitrazepam C Urinary Incontinence Date:09/08/00ISR Number: 3568805-7Report Type:Expedited (15-DaCompany Report #JRFBEL2000002173 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Risperdal PS Janssen Research Fdn Vomiting Health Div Johnson And Professional Johnson ORAL MG, DAILY, Other ORAL Metoclopramide (Metoclopramide) SS INTRAVENOUS IV Date:09/08/00ISR Number: 3568806-9Report Type:Expedited (15-DaCompany Report #JRFBEL2000002179 Age:40 YR Gender:Female I/FU:I Outcome PT Death Depressed Level Of Consciousness Drug Interaction Drug Level Above 22-Feb-2006 08:20 AM Page: 871 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Therapeutic Agent Toxicity Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Hydroxyzine Hydrochloride (Hydroxyzine Hydrochloride) SS Flunitrazepam (Flunitrazepam) SS Phenobarbital (Phenobarbital) SS Promethazine Hydrochloride (Promethazine Hydrochloride) SS Chlorpromazine And Preparations (Chlorpromazine) SS Biperiden And Preparations (Biperiden) SS Etizolam (Etizolam) SS Date:09/08/00ISR Number: 3568807-0Report Type:Expedited (15-DaCompany Report #JACGBR2000000657 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glomerulonephritis Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL 0.5 MG, DAILY, ORAL Date:09/08/00ISR Number: 3568808-2Report Type:Expedited (15-DaCompany Report #JACGER2000001422 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Condition Aggravated Health Div Johnson And Hyperprolactinaemia Professional Johnson ORAL MG, DAILY, Pericardial Effusion ORAL Pericarditis Date:09/11/00ISR Number: 3568187-0Report Type:Expedited (15-DaCompany Report #244216 Age:73 YR Gender:Female I/FU:I Outcome PT Death Abdominal Pain Hospitalization - Anaemia Initial or Prolonged Arthralgia Back Pain Condition Aggravated Dehydration Depressed Level Of Consciousness 22-Feb-2006 08:20 AM Page: 872 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Duodenal Ulcer Haemorrhage Report Source Product Role Manufacturer Route Dose Duration Ecchymosis Risperdal PS Embolism Naprosyn SS Roche 5 DAY Escherichia Infection Duragesic Patch SS Haematemesis Ibuprofen SS Roche Hiatus Hernia Prednisone SS Hypotension Tylenol C Musculoskeletal Pain Claritin C Myalgia Sinemet C Parkinson'S Disease Synthroid C Pathogen Resistance Zoloft C TAKEN AT Pneumonia NIGHT. Tardive Dyskinesia Restoril C TAKEN AT Tremor NIGHT. Urinary Tract Infection Ventolin C Vascular Malformation Atrovent C Peripheral Ceftin C Lorazepam C Date:09/11/00ISR Number: 3568208-5Report Type:Expedited (15-DaCompany Report #239346 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Valium PS Roche 1 DAY Inadequate Control Quilonum Retard SS 243 DAY Drug Level Above Orfiril SS 12 DAY Therapeutic Truxal SS 10 DAY Mania Truxal SS 8 DAY Pulse Absent Valium SS Roche 3 DAY Respiratory Arrest Truxal SS 7 DAY Stupor Risperdal SS 243 DAY Amaryl C 243 DAY Pirenzepine C 9 DAY Heparin C 5 DAY Date:09/11/00ISR Number: 3568899-9Report Type:Direct Company Report # Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bone Disorder Consumer Risperdal PS 1MG Hospitalization - Confusional State Temazepan C Initial or Prolonged Decreased Activity Restoril C Disability Decubitus Ulcer Paxil C Other Diabetes Mellitus Required Difficulty In Walking Intervention to Joint Stiffness Prevent Permanent Malaise Impairment/Damage Muscle Rigidity Neuroleptic Malignant Syndrome Senile Dementia Staphylococcal Infection Tremor Urinary Incontinence 22-Feb-2006 08:20 AM Page: 873 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/13/00ISR Number: 3571243-4Report Type:Expedited (15-DaCompany Report #00P-062-0097019-00(0) Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Depakene PS Abbott Laboratories Initial or Prolonged Confusional State Health Pharmaceutical Dizziness Professional Products Div ORAL 750 MG, 1 IN Fall Other 1 D, PER ORAL Grand Mal Convulsion Doxepin Nausea Hydrochloride Psychomotor Retardation (Doxepin Sedation Hydrochloride) SS ORAL 200 MG, 1 IN Tremor 1 D, PER ORAL Risperidone (Risperidone) SS ORAL 3 MG, 1 IN 1 D, PER ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) SS ORAL 0.5 IU, 1 IN 1 D, PER ORAL Date:09/13/00ISR Number: 3571414-7Report Type:Expedited (15-DaCompany Report #244216 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Consumer Naprosyn PS Syntex Fp Inc ORAL 500 MG ORAL Hospitalization - Anaemia Risperdal Initial or Prolonged Arthralgia (Risperidone) 1 Mg SS ORAL 1 MG DAILY 1 Back Pain PER DAY ORAL Blood Pressure Decreased Duragesic Patch Dehydration (Fentanyl Citrate) SS TOPICAL TOPICAL Depressed Level Of Ibuprofen Consciousness (Ibuprofen) SS ORAL 1 PER PRN Depression ORAL Duodenal Ulcer Prednisone Haemorrhage (Prednisone) SS ORAL ORAL Ecchymosis Tylenol C Escherichia Infection Claritin C Hiatus Hernia Sinemet C Musculoskeletal Pain Synthroid C Myalgia Zoloft C Parkinson'S Disease Restoril C Pneumonia Ventolin C Tardive Dyskinesia Atrovent C Tremor Ceftin C Urinary Tract Infection Lorazepam C Date:09/14/00ISR Number: 3571678-XReport Type:Expedited (15-DaCompany Report #239346 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Foreign Valium PS Hoffmann La Roche Drug Level Above Study Inc ORAL 30 MG DAILY Therapeutic Health ORAL Mania Professional Valium (Diazepam) SS INTRATUMOR 10 MG DAILY Pulse Absent INTRAVENOUS Respiratory Disorder Quilonum Retard Stupor (Lithium Carbonate) SS 1350 MG DAILY Orfiril (Valproate 22-Feb-2006 08:20 AM Page: 874 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) SS 600 MG DAILY Truxal (Chlorprothixene) SS ORAL 150 MG DAILY ORAL Truxal (Chlorprothixene) SS INTRAVENOUS 100 MG DAILY INTRAVENOUS Truxal (Chlorprothixene) SS ORAL 100 MG DAILY ORAL Risperdal (Risperidone) SS 6 MG DAILY Amaryl(Glimepiride) C Pirenzepine (Pirenzepine Hydrochloride) C Heparin (Heparin Sodium) C Date:09/15/00ISR Number: 3572035-2Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Risperdal 1mg PS ORAL 1MG QD ORAL Initial or Prolonged Lethargy Klonopin C Required Muscle Rigidity Intervention to Neuroleptic Malignant Prevent Permanent Syndrome Impairment/Damage Pyrexia Date:09/15/00ISR Number: 3572611-7Report Type:Expedited (15-DaCompany Report #JRFUSA2000007203 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Company Johnson ORAL ORAL Representative Mellaril (Thioridazine Hydrochloride) C Date:09/15/00ISR Number: 3572612-9Report Type:Expedited (15-DaCompany Report #JRFUSA2000004782 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ovarian Neoplasm Consumer Risperdal PS Janssen Research Fdn Div Johnson And Johnson ORAL 5 MG, 1 IN 1 DAY(S) ORAL ; 0.5 MG 1 IN 1 DAY(S) ORAL Zyprexa (Olanzapine) C Zoloft (Sertraline Hydrochloride) C Xanax (Alprazolam) C Klonopin (Clonazepam) C 22-Feb-2006 08:20 AM Page: 875 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/00ISR Number: 3572677-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000002189 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Paralysis Health Div Johnson And Required Rhabdomyolysis Professional Johnson ORAL MG, DAILY, Intervention to ORAL Prevent Permanent Luvox (Fluvoxamine Impairment/Damage Maleate) C Date:09/15/00ISR Number: 3572678-6Report Type:Expedited (15-DaCompany Report #JRFBEL2000001167 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Melleril (Thioridazine Hydrochloride) C Date:09/15/00ISR Number: 3572692-0Report Type:Expedited (15-DaCompany Report #JACFRA2000000588 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Risperdal PS Janssen Research Fdn Required Blood Creatine Health Div Johnson And Intervention to Phosphokinase Increased Professional Johnson ORAL ORAL Prevent Permanent Cardiac Arrest Laroxyl Impairment/Damage Condition Aggravated (Amitriptyline Convulsion Hydrochloride) C Drug Level Above Theralithe (Lithium Therapeutic Carbonate) C Dyskinesia Equanil Hyperreflexia (Meprobamate) C Neuroleptic Malignant Neurontin Syndrome (Gabapentin) C Pyrexia Rivotril Streptococcal Infection (Clonazepam) C Imovane (Zopiclone) C Sulfarlem (Anethole Trithione) C Skenan (Morphine Sulfate) C Date:09/15/00ISR Number: 3572693-2Report Type:Expedited (15-DaCompany Report #JACGER2000001129 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Hyponatraemia Health Div Johnson And Inappropriate Professional Johnson ORAL MG, DAILY, Antidiuretic Hormone ORAL Secretion Noveril (Dibenzepin Rhabdomyolysis Hydrochloride) C Stupor Orfiril (Valproate Sodium) C 22-Feb-2006 08:20 AM Page: 876 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/00ISR Number: 3572694-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000002167 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Increased Health Div Johnson And Chills Professional Johnson ORAL 2 MG, 1 IN 1 Dizziness DAY (S), ORAL Haematuria Orfiril (Valproate Liver Function Test Sodium) SS ORAL 600 MG, 2 IN Abnormal 1 DAY (S), Malaise ORAL Proteinuria Lithionit (Lithium Pyrexia Sulfate) C Rash Maculo-Papular Thrombocytopenia Date:09/15/00ISR Number: 3572819-0Report Type:Expedited (15-DaCompany Report #FLUV00300005064 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autonomic Nervous System Foreign Luvox PS Solvay Initial or Prolonged Imbalance Health Pharmaceuticals ORAL 150 MG DAILY Hyperhidrosis Professional PO Muscle Rigidity Other Serenace Neuroleptic Malignant (Haloperidol) SS ORAL 2 MG DAILY PO Syndrome Risperdal Pyrexia (Risperidone) SS ORAL 1 MG DAILY PO Stupor Date:09/18/00ISR Number: 3573057-8Report Type:Direct Company Report # Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Risperidone PS Initial or Prolonged Fall Fluoxetine SS Date:09/18/00ISR Number: 3573437-0Report Type:Periodic Company Report #A010999 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Consumer Navane PS Roerig Div Pfizer Pain Inc ORAL 10MG Rhinitis TOTAL/DAILY/O Sedation RAL Risperdal SS ORAL ORAL Zyprexa SS ORAL 20MG TOTAL/DAILY/O RAL Date:09/18/00ISR Number: 3574511-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000001608 Age:33 YR Gender:Female I/FU:F Outcome PT Other Catatonia Condition Aggravated Dizziness Drug Interaction 22-Feb-2006 08:20 AM Page: 877 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyskinesia Dystonia Ileus Paralytic Report Source Product Role Manufacturer Route Dose Duration Oculogyration Foreign Risperdal PS Janssen Research Fdn Orthostatic Hypotension Literature Div Johnson And Health Johnson ORAL MG, DAILY, Professional ORAL Midodrine (Midodrine) SS MG, DAILY Date:09/18/00ISR Number: 3574706-0Report Type:Expedited (15-DaCompany Report #JACFRA2000000593 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL MG, DAILY, Company ORAL Representative Anafranil (Clomipramine Hydrochloride) C Depamide (Valpromide) C Date:09/18/00ISR Number: 3574708-4Report Type:Expedited (15-DaCompany Report #JACGER2000001455 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Risperdal PS Janssen Research Fdn Hospitalization - Blood Creatinine Health Div Johnson And Initial or Prolonged Increased Professional Johnson ORAL MG, DAILY, Condition Aggravated Company ORAL Erysipelas Representative Aspirin Haematuria (Acetylsalicylic Pulmonary Oedema Acid) C Renal Impairment Voltaren (Diclofenac Sodium) C Date:09/18/00ISR Number: 3574709-6Report Type:Expedited (15-DaCompany Report #JACGER2000001456 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Myocardial Infarction Health Div Johnson And Renal Failure Professional Johnson ORAL MG, DAILY, Company ORAL Representative Date:09/18/00ISR Number: 3574710-2Report Type:Expedited (15-DaCompany Report #JACGER2000001422 Age:59 YR Gender:Female I/FU:F Outcome PT Hospitalization - Arrhythmia Initial or Prolonged Arthralgia Condition Aggravated Hyperprolactinaemia Joint Swelling 22-Feb-2006 08:20 AM Page: 878 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pericardial Effusion Pericarditis Pyrexia Report Source Product Role Manufacturer Route Dose Duration Viral Infection Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Date:09/18/00ISR Number: 3574888-0Report Type:Expedited (15-DaCompany Report #JRFUSA1999001399 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspartate Health Risperdal PS Janssen Research Fdn Required Aminotransferase Professional Div Johnson And Intervention to Increased Johnson ORAL 1 MG, 2 IN 1 Prevent Permanent Atherosclerosis DAY(S) ORAL; Impairment/Damage Blood Bilirubin Increased 2 MG, 2 IN 1 Blood Creatinine DAY(S), ORAL Increased Ativan SS ORAL 5, TOTAL, Blood Potassium Decreased ORAL Coma Zoloft (Sertraline Glomerulonephritis Hydrochloride) SS ORAL 50 MG, 1 IN 1 Chronic DAY(S), ORAL Hepatic Congestion Hyperglycaemia Pleural Infection Pulmonary Infarction Pulmonary Oedema Pulse Absent Pyrexia Renal Failure Acute Renal Tubular Necrosis Schizophrenia Date:09/20/00ISR Number: 3575613-XReport Type:Expedited (15-DaCompany Report #JACGBR2000000657 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Glomerulonephritis Foreign Risperdal PS Janssen Research Fdn Hospitalization - Health Div Johnson And Initial or Prolonged Professional Johnson ORAL MG, DAILY, Other ORAL Date:09/20/00ISR Number: 3575614-1Report Type:Expedited (15-DaCompany Report #JRFBEL2000002116 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephritis Interstitial Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Pollakiuria Health Div Johnson And Polydipsia Professional Johnson ORAL 1 MG, 1 IN 1 Polyuria Other NIGHT (S), Renal Impairment ORAL Urinary Incontinence Norvasc C Diaformin C Minidiab C Zoloft C Aldactone C Lanoxin C 22-Feb-2006 08:20 AM Page: 879 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Frusemide C Allopurinol C Date:09/20/00ISR Number: 3575682-7Report Type:Expedited (15-DaCompany Report #JRFBEL2000002215 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Haldol PS Rw Johnson Initial or Prolonged Suicidal Ideation Study Pharmaceutical Health Research Institute Professional Div Ortho Pharm ORAL 3 MG, 1 IN 1 DAY(S), ORAL Risperidone (Tablet) (Resperidone) SS ORAL 3 MG, , 1 IN 1 DAY(S), ORAL Date:09/20/00ISR Number: 3575940-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000007333 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Consumer Risperdal PS Janssen Research Fdn Div Johnson And Johnson ORAL ORAL Date:09/21/00ISR Number: 3576914-1Report Type:Expedited (15-DaCompany Report #A001638 Age:87 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anxiety Consumer Zoloft PS Pfizer Intervention to Condition Aggravated Health Pharmaceuticals Inc 50.00 MG Prevent Permanent Dementia Alzheimer'S Type Professional TOTAL:DAILY Impairment/Damage Depression Celebrex SS Dizziness Risperdal SS Gastrointestinal Toprol Xl C Haemorrhage Quinine Sulfate C Haematochezia Prilosec C Haemoglobin Decreased Furosemide C Hallucination Captopril C Lethargy Movement Disorder Oral Intake Reduced Speech Disorder Date:09/22/00ISR Number: 3577049-4Report Type:Direct Company Report # Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Coma Consumer Risperidal 1 Mg Intervention to Drooling Janssen PS Janssen 1 1/2MGS AM 3 Prevent Permanent Dysarthria 1/2 MGS PM Impairment/Damage Hemiplegia Depakote C Tremor Clonidine C 22-Feb-2006 08:20 AM Page: 880 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/00ISR Number: 3577061-5Report Type:Direct Company Report # Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperidone PS Professional Date:09/25/00ISR Number: 3579579-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000002241 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Risperdal PS Janssen Research Fdn Hospitalization - Syndrome Health Div Johnson And Initial or Prolonged Professional Johnson ORAL MG, DAILY, ORAL Tolvon (Mianserin Hydrochloride) C Efexor (Venlafaxine Hydrochloride) C .. C .. C Date:09/25/00ISR Number: 3579807-9Report Type:Expedited (15-DaCompany Report #JAUSA25236 Age:42 YR Gender:Male I/FU:F Outcome PT Required Abdominal Distension Intervention to Abdominal Pain Prevent Permanent Amnesia Impairment/Damage Aneurysm Angina Pectoris Blood Pressure Increased Borderline Glaucoma Burning Sensation Cardiac Aneurysm Cardiac Disorder Chest Pain Choroidal Dystrophy Circulatory Collapse Constipation Cyanosis Dermatitis Dizziness Drooling Dyskinesia Dyspepsia Dyspnoea Ear Discomfort Ecchymosis Electrocardiogram Qt Prolonged Embolism Erythema Eye Disorder Eye Pain Fatigue Gastrointestinal Disorder Gingival Bleeding Haematuria Haemoptysis 22-Feb-2006 08:20 AM Page: 881 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Head Injury Headache Hearing Impaired Report Source Product Role Manufacturer Route Dose Duration Hyperglycaemia Consumer Risperdal PS Janssen Research Fdn Hypoaesthesia Health Div Johnson And Hypotension Professional Johnson ORAL 1 MG, 2 IN 1 Hypothermia DAY (S), ORAL Infertility (SEE IMAGE) Keratoconjunctivitis Betoptic SS OPHTHALMIC OPHTHA Sicca Pravachol C Liver Disorder Selenium Sulfate C Liver Function Test Lotrisone Cream C Abnormal Niacin C Lymphoma Vitamin E C Movement Disorder Tylenol C Muscle Rigidity Ibuprofen C Nausea Fish Oil Concentrate C Neoplasm Maalox C Neoplasm Skin Neuroleptic Malignant Syndrome Oedema Pain Palpitations Pancreatic Disorder Paralysis Polyp Psychomotor Retardation Pyrexia Rash Erythematous Rash Macular Renal Failure Skin Discolouration Skin Disorder Sleep Apnoea Syndrome Sperm Count Decreased Spleen Disorder Systemic Lupus Erythematosus Tachycardia Testicular Disorder Testicular Pain Thinking Abnormal Tooth Disorder Toothache Urinary Incontinence Visual Acuity Reduced Visual Disturbance Visual Field Defect Weight Increased White Blood Cells Urine Positive Date:09/25/00ISR Number: 3579817-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000005786 Age: Gender:Unknown I/FU:F Outcome PT Report Source Hospitalization - Hyponatraemia Health Initial or Prolonged Professional Company 22-Feb-2006 08:20 AM Page: 882 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Risperdal PS Janssen Research Fdn Div Johnson And Johnson ORAL ORAL Date:09/25/00ISR Number: 3580029-6Report Type:Periodic Company Report #JAUSA37120 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen Research Fdn Initial or Prolonged Injury Div Johnson And Sedation Johnson ORAL 4 MG, 2 IN 1 Tardive Dyskinesia DAY(S) ORAL Tremor Depakote(Tablet) (Valproate Sodium) C Zyprexa (Tablet) (Olanzapine) C Cogentin (Benzatropine Mesilate) C Ativan (Lorazepam) C Date:09/25/00ISR Number: 3580030-2Report Type:Periodic Company Report #JRFUSA2000000786 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Increased Health Risperdal PS Janssen Research Fdn Initial or Prolonged Professional Div Johnson And Required Johnson ORAL 12 MG, DAILY, Intervention to ORAL, 120 MG, Prevent Permanent 1 IN 1 Impairment/Damage TIME(S), ORAL Cogentin (Benzatropine Mesilate) C Date:09/25/00ISR Number: 3580031-4Report Type:Periodic Company Report #JRFUSA2000004600 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal PS Janssen Research Fdn Initial or Prolonged Professional Div Johnson And Johnson ORAL 1.5 MG, 2 IN 1 DAY(S) ORAL Dextrose W/Potassium Chloride And Nacl (Galenic /Glucose/Sodiumcl/Po tassium Cl) C Ceftriaxone (Ceftriaxone) C Acetaminophen (Paracetamol) C 22-Feb-2006 08:20 AM Page: 883 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/00ISR Number: 3580032-6Report Type:Periodic Company Report #JRFUSA1999004355 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Speech Disorder Consumer Risperdal PS Janssen Research Fdn Initial or Prolonged Tardive Dyskinesia Div Johnson And Thinking Abnormal Johnson ORAL 4 MG 1 IN 1 DAY(S) ORAL Dexedrine (Dexamfetamine Sulfate) C Klonopin (Clonazepam) C Date:09/25/00ISR Number: 3591316-XReport Type:Periodic Company Report #JRFUSA2000004658 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Constipation Consumer Propulsid PS Janssen Research Fdn Diarrhoea Div Johnson And Johnson ORAL 10 MG, 2 IN 1 DAY (S), ORAL Risperdal (0.5 Mg Tablet) (Risperidone) SS ORAL 0.5 MG, 1 IN 1 DAY (S), ORAL Zantac C Baclofen C Bentyl C Dilacor C Date:09/26/00ISR Number: 3582119-0Report Type:Periodic Company Report #00-06-0319 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anticholinergic Syndrome Health Clozapine PS Zenith Goldline ORAL 25-300 MG Hospitalization - Diarrhoea Professional ORAL Initial or Prolonged Hyponatraemia Risperdal Tablets SS ORAL 4MG ORAL Hypotension Risperidone C Nausea Paroxetine C Thrombocytopenia Haloperidol C Vomiting Date:09/29/00ISR Number: 3584423-9Report Type:Expedited (15-DaCompany Report #A032221 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Health Zoloft PS Pfizer Initial or Prolonged Akathisia Professional Pharmaceuticals Inc ORAL ORAL Confusional State Risperdal SS ORAL 2.00 MG Grand Mal Convulsion TOTAL:BID:ORA Movement Disorder L Photosensitivity Reaction Depakote SS ORAL ORAL Ativan SS 22-Feb-2006 08:20 AM Page: 884 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/00ISR Number: 3585345-XReport Type:Expedited (15-DaCompany Report #PHRM2000FR01412 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malaise Foreign Exelon PS Novartis Other Nausea Health Pharmaceuticals Corp ORAL 3 MG, BID, Orthostatic Hypotension Professional ORAL Sudden Death Other Risperdal Urinary Retention (Risperidone) SS ORAL ORAL Seresta (Oxazepam) C Equanil (Meprobamate) C Duphalac C Speciafoldine Tablet C Date:10/02/00ISR Number: 3584714-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Risperidone PS Syndrome Date:10/02/00ISR Number: 3584721-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Risperidone PS Syndrome Date:10/02/00ISR Number: 3585621-0Report Type:Expedited (15-DaCompany Report #JACFRA2000000559 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Phosphokinase Increased Health Div Johnson And Depressed Level Of Professional Johnson ORAL MG, DAILY, Consciousness ORAL 57 DAY Hallucination Loxapac (Loxapine Muscle Rigidity Succinate) SS ORAL ML, DAILY, Neuroleptic Malignant ORAL Syndrome Topalgic (Tramadol Tachycardia Hydrochloride) C Depamide (Valpromide) C Myolastan (Tetrazepam) C Floxyfral (Fluvoxamine Maleate) C Cozzar (Losartan Potassium) C Date:10/02/00ISR Number: 3585638-6Report Type:Expedited (15-DaCompany Report #JACGBR2000000690 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Other Neutropenia Foreign Health 22-Feb-2006 08:20 AM Page: 885 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal PS Janssen Research Fdn Div Johnson And Johnson ORAL 0.5 MG, 2 IN 1 DAY(S), ORAL Paroxetine (Paroxetine) SS ORAL 20 MG, 1 IN 1 DAY(S), ORAL Becotide (Beclometasone Dipropionate) C Salbutamol (Salbutamol) C Date:10/02/00ISR Number: 3585642-8Report Type:Expedited (15-DaCompany Report #JRFBEL1999000345 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Autonomic Nervous System Literature Div Johnson And Required Imbalance Health Johnson ORAL MG, DAILY, Intervention to Blood Creatine Professional ORAL Prevent Permanent Phosphokinase Increased Madopar Hbs Impairment/Damage Bradykinesia (Madopar) SS LEVODOPA 100 Condition Aggravated MG/BENSERAZID Decreased Activity E 25 MG Delusion Trifluoperazine Extrapyramidal Disorder (Trifluoperazine) C Hyperhidrosis Bromocriptine Hypertension (Bromocriptine) C Muscle Rigidity Amitriptyline Neuroleptic Malignant (Amitriptyline) C Syndrome Paroxetine Neurotransmitter Level (Paroxetine) C Altered Oliguria Pyrexia Stupor Tachycardia Date:10/02/00ISR Number: 3585643-XReport Type:Expedited (15-DaCompany Report #JAKYO43538 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Foreign Risperdal PS Janssen Research Fdn Cholelithiasis Health Div Johnson And Dyskinesia Professional Johnson ORAL MG, DAILY, Hepatic Function Abnormal ORAL Salivary Hypersecretion Bromperidol Stomatitis (Unspecified) (Bromperidol) SS ORAL SEE IMAGE Haloperidol Decanoate (Injection) (Haloperidol Decanoate) SS INTRAMUSCULAR MG, DAILY, 22-Feb-2006 08:20 AM Page: 886 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report INFUSION, MG, DAILY, IM Fluphenazine (Fluphenazine) SS INTRAMUSCULAR 25 MG, DAILY, IM Biperiden Hydrochloride (Biperiden Hydrochloride) C Sennoside (Tablet) (Sennosides) C Tolbutamide (Tablet) (Tolbutamide) C Magnesium Oxide (Magnesium Oxide) C Daio-Kanzo-To (Daiokanzoto) C Date:10/02/00ISR Number: 3585725-2Report Type:Expedited (15-DaCompany Report #JRFBEL2000002285 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Supraventricular Foreign Risperdal PS Janssen Research Fdn Tachycardia Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Risperdal (Unspecified) (Risperidone) SS ORAL MG, DAILY, ORAL Meleril (Thioridazine Hydrochloride) C Benztropine (Benztropine) C Thyroxin (Levothyroxine Sodium) C Date:10/02/00ISR Number: 3585728-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000002319 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Water Intoxication Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Pentobarbital Calcium (Pentobarbital Calcium) C Flunitrazepam (Flunitrazepam) C Propericiazine (Perciazine) C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Haloperidol 22-Feb-2006 08:20 AM Page: 887 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Haloperidol) C Levomepromazine Maleate (Levomepromazine Maleate) C Promethazine Hydrochloride (Promethazine Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochlordie) C Sennoside (Sennoside A + B) C Carbamazepine (Carbamazepine) C Date:10/02/00ISR Number: 3585731-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000002326 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Decreased Health Div Johnson And Professional Johnson ORAL 2 MG, DAILY ORAL Effexor (Venlafaxine) C Date:10/02/00ISR Number: 3585733-1Report Type:Expedited (15-DaCompany Report #JRFBEL2000002189 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Risperdal PS Janssen Research Fdn Hospitalization - Blood Creatine Health Div Johnson And Initial or Prolonged Phosphokinase Increased Professional Johnson ORAL 2 MG, DAILY, Required Blood Pressure Diastolic ORAL Intervention to Decreased Luvox (Fluvoxamine Prevent Permanent Depressed Level Of Maleate) C Impairment/Damage Consciousness Prochlorperazine Difficulty In Walking Maleate Liver Function Test (Prochlorperazine Abnormal Maleate) C Pain Biperiden Paralysis Hydrochloride Renal Impairment (Biperiden Rhabdomyolysis Hydrochloride) C Thirst Date:10/02/00ISR Number: 3585736-7Report Type:Expedited (15-DaCompany Report #JRFBEL2000002335 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Food Poisoning Foreign Risperdal PS Janssen Research Fdn Foreign Body Aspiration Health Div Johnson And Vomiting Professional Johnson ORAL 3 MG, DAILY, ORAL Haloperidol (Haloperidol) C 22-Feb-2006 08:20 AM Page: 888 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Sultopride Hydrochloride (Sultopride Hydrochloride) C Levomepromazine Maleate (Levomepromazine Maleate) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Carbamazepine (Carbamazepine) C Brotizolam (Brotizolam) C Estazolam (Estazolam) C Vegetamin A (Vegetamin A) C Date:10/02/00ISR Number: 3585838-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000002327 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Depression Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Health Div Johnson And Required Professional Johnson ORAL ORAL Intervention to Chlorpromazine C Prevent Permanent Valproate C Impairment/Damage Date:10/02/00ISR Number: 3585889-0Report Type:Expedited (15-DaCompany Report #2000-09-0279 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tic Health Claritin PS Schering Corp Sub Professional Schering Plough Corp ORAL 10 MG/QD/PRN Company ORAL; 2-3 Representative MONTHS Risperdal SS Prozac C Flovent 2 Puffs/Bid C Flonase C Serevent Inhalation Aerosol 2puffs/Bid C Singulair (Montelukast Sodium) 5 Mg/Qhs C Rhinocort 2-4 Spry/Bid Intranasal C 22-Feb-2006 08:20 AM Page: 889 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/00ISR Number: 3586257-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mental Impairment Health Risperidone PS Professional Lorazepam SS Date:10/02/00ISR Number: 3586260-8Report Type:Direct Company Report # Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Health Risperidone 1mg PS BID 4 DAY Intervention to Professional Sinemet Cr 50/200 C Prevent Permanent Impairment/Damage Date:10/03/00ISR Number: 3586439-5Report Type:Direct Company Report # Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Risperidone 2mg Tab PS Initial or Prolonged Lisinopril C Donepezil Hcl C Cyanocobalamin Inj C Syringe C Vitamin E C Furosemide C Trazodone Hcl C Oxybutynin Chloride C Underpad, Bed Large Extra Absorbent C Diltiazem (Tiazac) C Cimetidine C Calcium Carbonate C Date:10/06/00ISR Number: 3589384-4Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Acrochordon Risperidone PS ORAL PATIENT NOT Complications Of Maternal SURE OF PO Exposure To Therapeutic DOSE 1ST 8 Drugs WKS OF Congenital Central PREGNANCY Nervous System Anomaly Valproic Acid SS Congenital Foot Malformation Microcephaly Neonatal Disorder Neonatal Respiratory Distress Syndrome Skin Disorder Skin Malformation Syndactyly 22-Feb-2006 08:20 AM Page: 890 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/00ISR Number: 3590818-XReport Type:Expedited (15-DaCompany Report #FLUV00200005918 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Consumer Luvox PS Solvay Initial or Prolonged Akathisia Pharmaceuticals ORAL DAILY PO Confusional State Risperdal Dyskinesia (Risperidone) SS ORAL 2 MG BID PO, Grand Mal Convulsion 1 MG BID PO, Photosensitivity Reaction 2 MG BID PO Depakote SS ORAL DAILY PO Zoloft (Sertraline Hydrochloride) SS ORAL DAILY PO Ativan C Date:10/06/00ISR Number: 3590888-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999000582 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Dystonia Health Div Johnson And Excitability Professional Johnson ORAL SEE IMAGE Haematemesis Haloperidol Impulse-Control Disorder (Unspecified) C Impulsive Behaviour Biperiden Jaw Disorder Hydrochloride C Mallory-Weiss Syndrome Refusal Of Treatment By Patient Schizophrenia Date:10/06/00ISR Number: 3590890-7Report Type:Expedited (15-DaCompany Report #JACGER2000001456 Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal PS Janssen Research Fdn Hospitalization - Myocardial Infarction Health Div Johnson And Initial or Prolonged Renal Failure Professional Johnson ORAL MG, DAILY, Company ORAL Representative Date:10/06/00ISR Number: 3590892-0Report Type:Expedited (15-DaCompany Report #JACGER2000001455 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Risperdal PS Janssen Research Fdn Condition Aggravated Health Div Johnson And Erysipelas Professional Johnson ORAL MG, DAILY, Haematuria Company ORAL Hyperkalaemia Representative Aspirin Pulmonary Oedema (Acetylsalicylic Pyrexia Acid) C Renal Impairment Voltaren (Diclofenac Sodium) C 22-Feb-2006 08:20 AM Page: 891 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/00ISR Number: 3590895-6Report Type:Expedited (15-DaCompany Report #JACGER2000000196 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Oedema Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Convulsion Health Div Johnson And Required Fall Professional Johnson ORAL 4 MG, 2 IN 1 Intervention to Hyperkalaemia DAY (S), ORAL Prevent Permanent Hyponatraemia Atosil Impairment/Damage Laceration (Isopromethazine Hydrochloride) C Ritonavir C Beta-Blocker ( Beta Blocking Agents) C Date:10/06/00ISR Number: 3590896-8Report Type:Expedited (15-DaCompany Report #JACGER2000000431 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Phosphokinase Increased Health Div Johnson And Depressed Level Of Professional Johnson ORAL SEE IMAGE Consciousness Droperidol SS 10 MG, 3 IN 1 Emotional Distress DAY (S), Encephalopathy Thioridazine C Feeling Jittery Fluoxetine C Head Banging Gaviscon C Hyperpyrexia Diazepam C Intentional Self-Injury Carbamazepine C Neuroleptic Malignant Syndrome Pyrexia Tremor White Blood Cell Count Increased Date:10/10/00ISR Number: 3591834-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000002370 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Literature Risperdal PS Janssen Research Fdn Initial or Prolonged Health Div Johnson And Professional Johnson 2 MG 2 IN 1 DAY(S) Valproic Acid (Valproic Acid) C Date:10/10/00ISR Number: 3591976-3Report Type:Direct Company Report # Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Risperidone PS 22-Feb-2006 08:20 AM Page: 892 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/10/00ISR Number: 3592542-6Report Type:Expedited (15-DaCompany Report #JACGER2000001557 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Tavor (Lorazepam) C Date:10/10/00ISR Number: 3592543-8Report Type:Expedited (15-DaCompany Report #JACGBR2000000756 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL 2 MG , DAILY, ORAL Donepezil (Donepezil) C Diazepam (Diazepam) C Citalopram (Citalopram) C Bendrofluazide (Bendroflumethiazide ) C Date:10/10/00ISR Number: 3592544-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000002319 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Pentobarbital Calcium (Pentobarbital Calcium) C Flunitrazepam (Flunitrazepam) C Propericiazine (Periciazine) C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Haloperidol (Haroperidol) C Levomepromzine Maleate (Levomepromazine Maleate) C Promethazine Hydrochloride (Promethazine Hydrochloride) C Biperidien Hydrochloride (Biperiden 22-Feb-2006 08:20 AM Page: 893 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Sennoside (Sennoside A+B) C Carbamazepine (Carbamazepine) C Date:10/10/00ISR Number: 3592545-1Report Type:Expedited (15-DaCompany Report #JAOCAN2000000938 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL ORAL Lithium (Lithium) SS ORAL ORAL Date:10/11/00ISR Number: 3592888-1Report Type:Direct Company Report # Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Risperidone 2 Mg Initial or Prolonged Restlessness (Janseen) PS (Janseen) ORAL PO BID Tardive Dyskinesia Clonidine C Multiple Vitamins With Minerals C Date:10/16/00ISR Number: 3595987-3Report Type:Expedited (15-DaCompany Report #JRFUSA000002365 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Female Consumer Risperdal PS Janssen Research Fdn Hospitalization - Constipation Div Johnson And Initial or Prolonged Metastases To Central Johnson ORAL ORAL Nervous System Effexor (Venlafaxine Oedema Hydrochloride) C Suicide Attempt Weight Increased Date:10/16/00ISR Number: 3596042-9Report Type:Expedited (15-DaCompany Report #JACFRA2000000593 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Risperdal PS Janssen Research Fdn Neutropenia Health Div Johnson And Professional Johnson ORAL 2 MG, 1 IN 1 Company DAY (S), ORAL Representative Anafranil C Depamide C Date:10/16/00ISR Number: 3596060-0Report Type:Expedited (15-DaCompany Report #FRFBEL2000002285 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Supraventricular Foreign Risperdal PS Janssen Research Fdn Tachycardia Health Div Johnson And Professional Johnson ORAL SEE IMAGE Meleril C Benztropine C 22-Feb-2006 08:20 AM Page: 894 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thyroxin C Date:10/16/00ISR Number: 3596061-2Report Type:Expedited (15-DaCompany Report #JACGBR2000000657 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Glomerulonephritis Foreign Risperdal PS Janssen Research Fdn Hospitalization - Renal Impairment Health Div Johnson And Initial or Prolonged Professional Johnson ORAL MG, DAILY, Disability ORAL Date:10/16/00ISR Number: 3596062-4Report Type:Expedited (15-DaCompany Report #JACFRA2000000649 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Aminotransferase Health Div Johnson And Increased Professional Johnson ORAL 1 MG, 1 IN 1 Blood Creatine DAY (S) , Phosphokinase Increased ORAL Blood Lactate Lysanxia C Dehydrogenase Increased Levothyrox C Myalgia Previscan C Euphytose C Date:10/16/00ISR Number: 3596063-6Report Type:Expedited (15-DaCompany Report #JACFRA2000000669 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Tegretol (Carbamazepine) SS ORAL MG, DAILY, ORAL Date:10/16/00ISR Number: 3596417-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000002454 Age:53 YR Gender:Male I/FU:I Outcome PT Death Calculus Urinary Haematuria Hepatic Steatosis Hyperpyrexia Inflammation Myocardial Fibrosis Neuroleptic Malignant Syndrome Prothrombin Time Prolonged Pyrexia Renal Neoplasm Renal Tubular Disorder Renal Tubular Necrosis Spleen Disorder Ultrasound Doppler 22-Feb-2006 08:20 AM Page: 895 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Urinary Tract Obstruction Ventricular Hypertrophy Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Entumin(Clotiapine) SS ORAL MG, DIALY, ORAL Akineton(Biperiden Hydrochloride) C Acetalgin(Paracetamo l) C Date:10/16/00ISR Number: 3596418-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000002463 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal PS Janssen Research Fdn Study Div Johnson And Health Johnson ORAL MG, DAILY, Professional ORAL Aldozone(Aldactone-S altucin) C Lasix(Furosemide) C Uniphyl(Theophylline ) C Date:10/17/00ISR Number: 3596646-3Report Type:Direct Company Report # Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Risperidone PS Date:10/19/00ISR Number: 3597698-7Report Type:Direct Company Report # Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperidone 25 Mg - Initial or Prolonged Binocular Eye Movement Janssen PS Janssen ORAL 2 MG PO BID Disorder Depakote C Heart Rate Increased Nicotine C Tongue Disorder Visual Disturbance Date:10/20/00ISR Number: 3598930-6Report Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I Outcome PT Life-Threatening Bradykinesia Hospitalization - Eye Movement Disorder Initial or Prolonged Joint Stiffness Required Muscle Rigidity Intervention to Neuroleptic Malignant Prevent Permanent Syndrome Impairment/Damage Physical Examination Abnormal 22-Feb-2006 08:20 AM Page: 896 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Posturing Restlessness Report Source Product Role Manufacturer Route Dose Duration Zyprexa -Olanzapine- 10mg Eli Lilly PS Eli Lilly ORAL 10MG QHS ORAL Risperdal -Risperidone- 2mg Janssen SS Janssen ORAL 2MG TID ORAL Date:10/23/00ISR Number: 3599967-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000000365 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Consumer Risperdal PS Janssen Research Fdn Hospitalization - Coronary Artery Disease Health Div Johnson And Initial or Prolonged Cough Professional Johnson ORAL 1 MG, 2 IN 1 Required Dysphagia DAY(S), ORAL Intervention to Dyspnoea Pepcid (Famotidine) C Prevent Permanent Ill-Defined Disorder Remeron Impairment/Damage Mental Impairment (Mirtazapine) C Myocardial Infarction Ativan (Lorazepam) C Nasopharyngeal Disorder Lisinopril Neoplasm (Lisinopril) C Peripheral Vascular Trazodone Disorder (Trazodone) C Prostate Cancer Aspirin Renal Impairment (Acetylsalicylic Salivary Hypersecretion Acid) C Coumadin (Warfarin Sodium) C Prednisone (Predinisone) C Date:10/23/00ISR Number: 3599969-7Report Type:Expedited (15-DaCompany Report #JRFUSA2000008201 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Company Risperdal PS Janssen Research Fdn Representative Div Johnson And Johnson ORAL ORAL Date:10/23/00ISR Number: 3600548-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000002285 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Risperdal PS Janssen Research Fdn Prolonged Health Div Johnson And Supraventricular Professional Johnson ORAL SEE IMAGE Tachycardia Meleril C Benztropine C Thyroxin C 22-Feb-2006 08:20 AM Page: 897 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/23/00ISR Number: 3600549-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000002104 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circadian Rhythm Sleep Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Disorder Health Div Johnson And Circulatory Collapse Professional Johnson ORAL SEE IMAGE Convulsion Biperiden Crying Hydrochloride C Depressed Level Of Haloperidol C Consciousness Chlorpromazine Electroencephalogram Hydrochloride C Abnormal Amezinium Fatigue Metilsulfaate C Headache Flunitrazepam C Suicidal Ideation Urinary Incontinence Date:10/23/00ISR Number: 3600550-1Report Type:Expedited (15-DaCompany Report #JACGER2000001557 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Tavor C Date:10/23/00ISR Number: 3600554-9Report Type:Expedited (15-DaCompany Report #JACGER2000001608 Age:96 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal PS Janssen Research Fdn Leukopenia Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Dipiperon C Ismo C Dytide C Novodigal C Date:10/25/00ISR Number: 3601303-0Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Risperdal 1mg & 2mg PS TITRATED FROM Initial or Prolonged 0.3MG BID TO 2MG AND 3MGHS Acetaminophen C Aldactazide C Cogentin C Date:10/26/00ISR Number: 3602156-7Report Type:Expedited (15-DaCompany Report #JRFUSA2000002365 Age:47 YR Gender:Female I/FU:F Outcome Death Hospitalization - 22-Feb-2006 08:20 AM Page: 898 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Consumer Risperdal PS Janssen Research Fdn Breast Disorder Health Div Johnson And Breast Engorgement Professional Johnson ORAL ORAL Constipation Effexor (Venlafaxine Cough Hydrochloride) C Depression Klonopin Dyspnoea (Clonazepam) C Erythema Headache Inflammatory Carcinoma Of The Breast Lymphadenopathy Mastitis Metastases To Central Nervous System Nausea Oedema Pain Suicide Attempt Weight Increased Date:10/26/00ISR Number: 3602157-9Report Type:Expedited (15-DaCompany Report #JRFUSA2000005952 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Posturing Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL ORAL Date:10/26/00ISR Number: 3602213-5Report Type:Expedited (15-DaCompany Report #PHRM2000FR01529 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Distension Foreign Exelon PS Novartis Bladder Disorder Health Pharmaceuticals Corp ORAL 3 MG, BID, Malaise Professional ORAL Nausea Other Risperdal Syncope (Risperidone) Tablet SS ORAL 1 MG, QD, ORAL Equanil (Meprobamate) C Speciafoldine C Seresta (Oxazepam) C Duphalac C Date:10/26/00ISR Number: 3602230-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000002541 Age:78 YR Gender:Female I/FU:I Outcome PT Death Agitation Crying Depression Excitability Pneumonia Sleep Phase Rhythm 22-Feb-2006 08:20 AM Page: 899 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disturbance Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal PS Janssen Research Fdn Study Div Johnson And Health Johnson ORAL MG, DAILY, Professional ORAL Clopixol (Zuclopenthixol Decanoate) C Augmentin (Clavulin) C Date:10/26/00ISR Number: 3602232-9Report Type:Expedited (15-DaCompany Report #JACFRA2000000698 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malaise Foreign Risperdal PS Janssen Research Fdn Life-Threatening Nausea Health Div Johnson And Syncope Professional Johnson ORAL 1 MG, 1 IN 1 DAY(S), ORAL Exelon (Rivastigmine) SS ORAL 3 MG, 2 IN 1 DAY(S), ORAL Equanil (Meprobamate) C Speciafoldine (Folic Acid) C Seresta (Oxazepam) C Duphalac (Lactulose) C Date:10/26/00ISR Number: 3602233-0Report Type:Expedited (15-DaCompany Report #JACGER2000001630 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Risperdal PS Janssen Research Fdn Hypotension Health Div Johnson And Loss Of Consciousness Professional Johnson ORAL 1 MG, 2 IN 1 Syncope Other DAY (S), ORAL Dipiperon C Isoket C Lopirin C Date:10/26/00ISR Number: 3602234-2Report Type:Expedited (15-DaCompany Report #JRFBEL2000002531 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Facial Palsy Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Monoparesis Health Div Johnson And Tongue Paralysis Professional Johnson ORAL 1 MG, 1 IN 1 Other DAY (S), ORAL; 2 MG, 1 IN 1 DAY (S), ORAL; 0.5 MG, Prothiaden C 22-Feb-2006 08:20 AM Page: 900 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/00ISR Number: 3602165-8Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Risperidone PS Date:10/27/00ISR Number: 3609775-2Report Type:Periodic Company Report #8-99257-001A Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Ativan PS Wyeth Ayerst Initial or Prolonged Drug Withdrawal Syndrome Laboratories ORAL 0.5 MG 1X PER 1 DAY, ORAL Risperdal (Risperidone, Tablet) SS ORAL .5 MG DAILY, ORAL Synthroid (Levothyroxine) C Glipizide (Glipizide) C Date:10/30/00ISR Number: 3603003-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Risperdal 2 Mg Intervention to Janssen PS Janssen Prevent Permanent Impairment/Damage Date:10/30/00ISR Number: 3603004-1Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Erection Increased Risperdal 0.5 Mg Intervention to Urinary Hesitation Janssen PS Janssen ORAL 0.5 MG HS Prevent Permanent ORAL Impairment/Damage Date:10/30/00ISR Number: 3603801-2Report Type:Expedited (15-DaCompany Report #9940425 Age:58 YR Gender:Male I/FU:I Outcome PT Death Arrhythmia Cardiac Arrest Drug Interaction Drug Level Above Therapeutic Gastrooesophageal Reflux Disease Hepatic Artery Thrombosis Hepatic Congestion Myocardial Fibrosis Oesophageal Stenosis Oesophagitis Overdose Pulmonary Congestion 22-Feb-2006 08:20 AM Page: 901 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sudden Death Urinary Incontinence Report Source Product Role Manufacturer Route Dose Duration Health Zoloft PS Pfizer Professional Pharmaceuticals Inc ORAL 100.00 MG Company TOTAL:DAILY:O Representative RAL Amlodipine SS ORAL 5.00 MG TOTAL:DAILY:O RAL Risperidone SS ORAL 6.00 MG TOTAL:BID:ORA L Cisapride SS ORAL 40.00 MG TOTAL:QID:ORA L Prilosec C Hydrochlorothiazide C Cotrimoxazole C Bactrim Ds C Date:10/31/00ISR Number: 3603586-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemolysis Risperdal 1mg Po Bid PS ORAL 1 MG PO BID Jaundice Cholestatic Phenytoin 800 Mg Iv Qd SS INTRAVENOUS 800 MG/ 16 ML IV QD Busprone C Digoxin C Enalaprilat C Lovenox C Levaquin C Metoprolol C Ranitidine C Morphine C Apap C Lorazepam C Date:10/31/00ISR Number: 3604799-3Report Type:Expedited (15-DaCompany Report #200021342FR Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Foreign Lasix PS Aventis Hospitalization - Distress Syndrome Other Pharmaceuticals Inc ORAL 100 MG DAY PO Initial or Prolonged Convulsion Ambroxol Hypotension Hydrochloride Loss Of Consciousness (Surbronc) SS ORAL 4 U/DAY PO Shock Milnacipran (Ixel) Syncope Capsules SS ORAL 100 MG/DAY PO Vomiting Theophylline (Euphylline L.A.) Capsules SS ORAL 800 MG DAY PO Furosemide (Lasilix Faible) Tablets SS ORAL 1 U/DAY PO Risperidone (Risperdal) Tablets SS ORAL 4 MG/DAY PO 22-Feb-2006 08:20 AM Page: 902 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/00ISR Number: 3605626-0Report Type:Expedited (15-DaCompany Report #FLUV00200005918 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Consumer Luvox PS Solvay Hospitalization - Aggression Pharmaceuticals ORAL SEE IMAGE Initial or Prolonged Akathisia Risperdal Attention (Risperidone) SS ORAL SEE IMAGE Deficit/Hyperactivity Depakote (Valproate Disorder Semisodium) SS ORAL 500 MG BID PO Confusional State Zoloft (Sertraline Disorientation Hydrochloride) SS ORAL 50 MG DAILY Grand Mal Convulsion PO Hyperacusis Ativan C Movement Disorder Photophobia Serotonin Syndrome Urinary Incontinence Date:11/01/00ISR Number: 3606664-4Report Type:Periodic Company Report #JRFUSA2000005328 Age:3 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sedation Health Sporanox PS Janssen Research Fdn Initial or Prolonged Professional Div Johnson And Required Johnson Intervention to Risperdal Prevent Permanent (Risperidone) SS Impairment/Damage Date:11/02/00ISR Number: 3606590-0Report Type:Periodic Company Report #10414217 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Buspar PS Bristol Myers Squibb Professional Co Pharmaceutical Research Institute ORAL ORAL Serzone Tabs (Nefazodone Hcl) SS ORAL ORAL Risperdal (Risperidone) SS Dilantin (Phenytoin) SS Date:11/03/00ISR Number: 3606649-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Zyprexa 25mg Qd PS 5 MG AM 20 MG Initial or Prolonged HS Risperdal 5mg Qd SS 2MG AM 3 MG HS Cogentin C Depakote C Ativan C 22-Feb-2006 08:20 AM Page: 903 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/00ISR Number: 3607025-4Report Type:Expedited (15-DaCompany Report #00P-163-0099113-00(0) Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Consumer Depakote PS Abbott Laboratories ORAL PER ORAL Initial or Prolonged Akathisia Other Risperidone Confusional State (Risperidone) SS ORAL 2 MG, 2 IN 1 Dyskinesia D, PER ORAL Grand Mal Convulsion Lorazepam Photosensitivity Reaction (Lorazepam) C Date:11/06/00ISR Number: 3607369-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Risperadal PS Date:11/06/00ISR Number: 3607604-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000002573 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Risperdal PS Janssen Research Fdn Hospitalization - Body Temperature Health Div Johnson And Initial or Prolonged Decreased Professional Johnson ORAL MG, DAILY, Depressed Level Of ORAL Consciousness Biperiden Hcl Dysphagia (Biperiden Hypothermia Hydrochloride) SS ORAL TABLE, DAILY, ORAL Estazolam (Estazolam) SS ORAL MG, DAILY, ORAL Date:11/06/00ISR Number: 3607606-8Report Type:Expedited (15-DaCompany Report #JACGER2000001632 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eyelid Ptosis Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Remergil (Mirtazapine) SS ORAL MG, DAILY, ORAL Date:11/06/00ISR Number: 3607607-XReport Type:Expedited (15-DaCompany Report #JACFRA2000000709 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Benign Congenital Initial or Prolonged Hypotonia Required Complications Of Maternal Intervention to Exposure To Therapeutic Prevent Permanent Drugs Impairment/Damage Depressed Level Of Consciousness Electroencephalogram Abnormal 22-Feb-2006 08:20 AM Page: 904 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeding Disorder Neonatal Foetal Macrosomia Hypoglycaemia Neonatal Report Source Product Role Manufacturer Route Dose Duration Leukopenia Neonatal Foreign Risperdal PS Janssen Research Fdn Pregnancy Health Div Johnson And Somnolence Neonatal Professional Johnson ORAL ORAL Toxicologic Test Abnormal Nozinan Vasodilatation (Levomepromazine) SS ORAL MG, DAILY, ORAL Tranxene (Clorazepate Dipotassium) SS SEE IMAGE Haldol (Unspecified)(Halope ridol) C Largactil (Chlorpromazine Hydrochloride) C Dogmatil (Sulpiride) C Hept-A-Myl (Heptaminol Hydrochloride) C Artane (Trihexyphenidyl Hydrochloride) C Rivotril (Clonazepam) C Valium (Diazepam) C Lepticur (Tropatepine Hydrochloride) C Ginkor Fort (Ginkor) C Tercian (Cyamemazine) C Date:11/06/00ISR Number: 3607609-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000002326 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Decreased Health Div Johnson And Professional Johnson ORAL 2 MG, DAILY, ORAL Efexor (Venlafaxine Hydrochloride) C Date:11/06/00ISR Number: 3608059-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000008618 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Risperdal PS Janssen Research Fdn Decreased Professional Div Johnson And Johnson ORAL 3 MG, 1 IN 1 DAY(S); ORAL Adderall (Obetrol) C Depakote (Valproate Semisodium) C 22-Feb-2006 08:20 AM Page: 905 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/00ISR Number: 3608060-2Report Type:Expedited (15-DaCompany Report #JRFUSA2000007203 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Risperdal PS Janssen Research Fdn Hospitalization - Fall Professional Div Johnson And Initial or Prolonged Pulse Absent Company Johnson ORAL 2 MG, 1 IN 1 Required Representative DAY(S); ORAL Intervention to Mellaril Prevent Permanent (Thioridazine Impairment/Damage Hydrochloride) SS ORAL 200 MG, 1 IN 1 DAY(S); ORAL Tegretol (Carbamazepine) C Prevacid (Lansoprazole) C Axpirin (Acetylsalicylic Acid) C Tofranol (Imipramine Hydrochloride) C Date:11/06/00ISR Number: 3608061-4Report Type:Expedited (15-DaCompany Report #JRFUSA2000008746 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pancytopenia Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL 0.5 MG, 3 IN 1 DAY(S); ORAL Date:11/06/00ISR Number: 3608062-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000008742 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Risperdal PS Janssen Research Fdn Hospitalization - Coma Professional Div Johnson And Initial or Prolonged Johnson ORAL 1 MG, 1 IN 1 Required NIGHT(S); Intervention to ORAL Prevent Permanent Mellaril Impairment/Damage (Thioridazine Hydrochloride) SS 50 MG; 75 MG, 2 IN 1 DAY(S) Zantac (Ranitidine Hydrochloride) C Vitamin C (Ascorbic Acid) C Lopid (Gemfibrozil) C Date:11/06/00ISR Number: 3610475-3Report Type:Periodic Company Report #2000027047US Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Consumer Detrol PS Pharmacia And Upjohn Penis Disorder Co ORAL ORAL Risperidone SS 22-Feb-2006 08:20 AM Page: 906 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tylenol SS Benadryl SS Colace(Docusate Sodium) SS Deltasone (Prednisone) SS Flomax SS Nefazogone SS Gabapentin C Date:11/07/00ISR Number: 3608377-1Report Type:Expedited (15-DaCompany Report #JRFBEL2000000935 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Disorder Foreign Risperdal PS Janssen Research Fdn Conduction Disorder Study Div Johnson And Electrocardiogram Health Johnson ORAL 4 MG, 1 IN 1 Abnormal Professional DAY(S), ORAL Date:11/09/00ISR Number: 3610333-4Report Type:Expedited (15-DaCompany Report #HQ3200303NOV2000 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Study Ativan PS Wyeth Ayerst Initial or Prolonged Consciousness Laboratories ORAL 0.5 MG, 1.0 Other Dysarthria MG, 1.5 MG, Fatigue 0.75 MG DAILY Sedation ORAL 4 DAY Speech Disorder Akineton (Biperidem Hydrochloride, ) SS ORAL 4 MG, 2 MG (NORMAL RELEASE), 8 MG DAILY 3 DAY Amitriptyline (Amitriptyline, ) SS ORAL 25 MG DAILY "MONTHS" Risperdal (Risperidone, ) SS ORAL 2 MG, 3MG, 4 MG, DAILY ORAL 5 DAY Glucophage (Metformin Hydrochloride) C Sonata (Zaleplon) C Clexane (Heparin-Fraction, Sodium Salt) C Torasemide (Torasemide) C Isosorbide (Isosorbide) C Date:11/09/00ISR Number: 3612999-1Report Type:Expedited (15-DaCompany Report #JRFBEL2000002736 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Death Death Foreign Health 22-Feb-2006 08:20 AM Page: 907 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal PS Janssen Research Fdn Div Johnson And Johnson Entumin (Clotiapine) SS Date:11/13/00ISR Number: 3610768-XReport Type:Direct Company Report # Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Risperidone / 0.5mg Hospitalization - Cyanosis Tablet / Janssen PS Janssen ORAL 0.5MG , BID, Initial or Prolonged Dyspnoea ORAL Other Dystonia Paroxetine , 10mg Sedation Tablet , Skb SS Skb ORAL 10MG, QAM, Torticollis ORAL Tremor Dexadrine C Date:11/13/00ISR Number: 3610808-8Report Type:Expedited (15-DaCompany Report #JRFUSA2000005328 Age:3 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Sporanox PS Janssen Research Fdn Initial or Prolonged Drug Level Above Professional Div Johnson And Required Therapeutic Johnson ORAL 40 MG, 1 IN 1 Intervention to Mental Impairment DAY (S), ORAL Prevent Permanent Oliguria Risperdal Impairment/Damage Oral Intake Reduced (Unspecified) Sedation (Risperidone) SS ORAL Pseudoephedrine (Pseudoephedrine) SS Ibuprofin C Date:11/13/00ISR Number: 3611217-8Report Type:Periodic Company Report #FLUV00299000923 Age:8 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Incontinence Health Luvox PS Solvay Professional Pharmaceuticals ORAL 25 MG QD PO Depakote (Valproate Semisodium) SS ORAL PO Risperdal (Risperidone) SS ORAL PO Date:11/13/00ISR Number: 3614246-3Report Type:Periodic Company Report #FLUV00299001195 Age:23 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Drug Interaction Drug Level Above Therapeutic Drug Level Below Therapeutic Hostility 22-Feb-2006 08:20 AM Page: 908 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychotic Disorder Report Source Product Role Manufacturer Route Dose Duration Literature Luvox PS Solvay Pharmaceuticals ORAL 200 MG DAILY PO, 100 MG DAILY PO, 50 MG DAILY PO, 25 MG DAILY Risperdal SS ORAL 10 MG DAILY PO Mellaril SS ORAL 300 MG DAILY PO, 500 MG DAILY PO, 300 MG DAILY PO, 200 MG DAILY Tegretol SS ORAL 1000 MG DAILY PO, 800 MG DAILY PO, 200 MG DAILY PO Clozapine SS ORAL SEE IMAGE Depakote C Cogentin C Mysoline C Date:11/14/00ISR Number: 3611449-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Asthenopia Lamictal PS ORAL LAM: 75 MG PO Other Chills Q 12 H Decreased Activity Risperdal SS ORAL RISP: 1 MG Eye Movement Disorder QD, PO Muscle Contractions Involuntary Nausea Palpitations Paraesthesia Pruritus Sedation Tremor Date:11/14/00ISR Number: 3611582-1Report Type:Expedited (15-DaCompany Report #PHEH2000US10152 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Mellaril PS Novartis Hospitalization - Drug Interaction Professional Pharmaceuticals Corp ORAL SEE IMAGE, Initial or Prolonged BID, ORAL Risperdal(Risperidon e) Tablet SS ORAL 1 MG, QHS, ORAL Zantac C Vitamin C (Ascorbic Acid) C Lopid (Gemfibrozil) C 22-Feb-2006 08:20 AM Page: 909 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/00ISR Number: 3612112-0Report Type:Expedited (15-DaCompany Report #PHEH1999US16225 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Tegretol PS Novartis Initial or Prolonged Agitation Professional Pharmaceuticals Corp MG, QD, ORAL Condition Aggravated Mellaril Drug Interaction (Thioridazine Drug Level Below Hydrochloride) SS ORAL ORAL Therapeutic Luvox(Fluvixamine Psychotic Disorder Maleate) Tablet SS ORAL MG, QD, ORAL Risperdal (Risperidone) Tablet, 10 Mg SS ORAL 10 MG, QD, ORAL Mysoline Tablet C Cogentin Tablet C Depakote Tablet C Clozapine C Date:11/15/00ISR Number: 3612207-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000008742 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxia Health Risperdal PS Janssen Research Fdn Hospitalization - Cardiac Arrest Professional Div Johnson And Initial or Prolonged Chest Pain Johnson ORAL 1 MG, 1 IN 1 Required Coma NIGHT (S), Intervention to Coronary Artery Disease ORAL Prevent Permanent Encephalopathy Mellaril SS 50 MG, 2 IN 1 Impairment/Damage DAY(S) (SEE IMAGE) Zantac C Vitamin C C Lopid C Date:11/15/00ISR Number: 3612209-5Report Type:Expedited (15-DaCompany Report #JRFUSA2000009107 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Risperdal PS Janssen Research Fdn Initial or Prolonged Electrocardiogram Professional Div Johnson And Abnormal Johnson ORAL 1 MG, 2 IN 1 Wolff-Parkinson-White DAY(S), ORAL Syndrome Depakote C Date:11/15/00ISR Number: 3612472-0Report Type:Expedited (15-DaCompany Report #2000034422ES Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Rhabdomyolysis Foreign Xanax PS Pharmacia And Upjohn Hospitalization - Health Co ORAL ORAL Initial or Prolonged Professional Risperdal(Risperidon Other e)1mg SS ORAL ORAL Lantanon(Mianserin Hydrochloride)30mg SS ORAL 30 MG, TID, ORAL 22-Feb-2006 08:20 AM Page: 910 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/00ISR Number: 3612533-6Report Type:Expedited (15-DaCompany Report #JRFBEL2000002651 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Laryngospasm Health Div Johnson And Suspiciousness Professional Johnson 4 MG, 1 IN 1 DAY(S) Zyprexa (Olanzapine) C Phenergan (Promethazine Hydrochloride) C Date:11/15/00ISR Number: 3612536-1Report Type:Expedited (15-DaCompany Report #JACGER2000001717 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Orthostatic Hypotension Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Entumin (Clotiapine) SS ORAL MG, DAILY, ORAL Lasix (Furosemide) SS ORAL MG, DAILY, ORAL Tenormin (Atenolol) SS ORAL MG, DAILY, ORAL Seropram (Citalopram Hydrobromide) C Bactrim Forte (Bactrim) C Date:11/15/00ISR Number: 3612537-3Report Type:Expedited (15-DaCompany Report #JACGER2000001703 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Sedation Health Div Johnson And Required Professional Johnson ORAL MG, DAILY, Intervention to ORAL Prevent Permanent Methadon (Methadone) SS ORAL MG, DAILY, Impairment/Damage ORAL Date:11/15/00ISR Number: 3612538-5Report Type:Expedited (15-DaCompany Report #JACFRA2000000741 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autonomic Nervous System Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Imbalance Health Div Johnson And Confusional State Professional Johnson ORAL ORAL Pyrexia Company Haldol (Unspecified) Representative (Haloperidol) C 22-Feb-2006 08:20 AM Page: 911 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/00ISR Number: 3612539-7Report Type:Expedited (15-DaCompany Report #JRFBEL2000002696 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Rhabdomyolysis Foreign Risperdal PS Janssen Research Fdn Hospitalization - Health Div Johnson And Initial or Prolonged Professional Johnson ORAL MG, DAILY, ORAL Lantanon (Mianserin Hydrochloride) SS ORAL MG, DAILY, ORAL Trankimazin Retard (Alprazolam) SS ORAL ORAL Date:11/15/00ISR Number: 3612540-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000002463 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal PS Janssen Research Fdn Condition Aggravated Study Div Johnson And Dyspnoea Health Johnson ORAL MG DAILY ORAL Psychotic Disorder Professional Aldozone Sedation (Aldactone-Saltucin) C Lasix (Furosemide) C Uniphyl (Theophylline) C Date:11/15/00ISR Number: 3612579-8Report Type:Expedited (15-DaCompany Report #PHEH2000US10151 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Mellaril PS Novartis Hospitalization - Drug Interaction Professional Pharmaceuticals Corp ORAL 200 MG, QD, Initial or Prolonged Fall ORAL Pulse Absent Risperdal (Risperidone) SS ORAL 2 MG, QD, ORAL Prevacid (Lansoprazole) C Acetylsalicylic Acid C Tofranil C Tegretol C Date:11/15/00ISR Number: 3612767-0Report Type:Expedited (15-DaCompany Report #JRFUSA2000009006 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL ORAL Date:11/15/00ISR Number: 3612768-2Report Type:Expedited (15-DaCompany Report #JRFUSA2000008980 Age:43 YR Gender:Female I/FU:I Outcome Death Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 912 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Apnoea Health Risperdal PS Janssen Research Fdn Hypoventilation Professional Div Johnson And Pulse Absent Johnson ORAL 1 MG, 2 IN 1 Tachycardia DAY(S), ORAL Levaquin (Levofloxacin) C Kcl (Potassium Chloride) C Dyazide (Dyazide) C Date:11/15/00ISR Number: 3612771-2Report Type:Expedited (15-DaCompany Report #JRFUSA2000005870 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Johnson Date:11/15/00ISR Number: 3612772-4Report Type:Expedited (15-DaCompany Report #JRFUSA2000009068 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Arrest Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL ORAL Date:11/15/00ISR Number: 3612774-8Report Type:Expedited (15-DaCompany Report #JRFUSA2000009066 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Arrest Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL ORAL Date:11/15/00ISR Number: 3612776-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000009063 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Arrest Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL ORAL Date:11/15/00ISR Number: 3612777-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000009047 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Arrest Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL ORAL 22-Feb-2006 08:20 AM Page: 913 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/00ISR Number: 3612918-8Report Type:Expedited (15-DaCompany Report #JRFUSA2000008903 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Glaucoma Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Company Johnson ORAL ORAL Representative Date:11/16/00ISR Number: 3612919-XReport Type:Expedited (15-DaCompany Report #JRFUSA2000000365 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Consumer Risperdal PS Janssen Research Fdn Cerebrovascular Accident Health Div Johnson And Chronic Obstructive Professional Johnson ORAL 1 MG, 2 IN 1 Pulmonary Disease DAY (S) , Condition Aggravated ORAL Cough Levaquin C Dysphagia Pepcid C Dyspnoea Remeron C Mental Impairment Ativan C Myocardial Infarction Lisinopril C Nasopharyngeal Disorder Trazodone C Neoplasm Aspirin C Pneumonia Coumadin C Renal Impairment Prednisone C Salivary Hypersecretion Nitro-Bid C Nitro C Lasix C Ranitidine C Demadex C Cozaar C K-Effervesce C Lonox C Hydrocodone C Date:11/16/00ISR Number: 3612937-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000008897 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL ORAL Date:11/16/00ISR Number: 3612946-2Report Type:Expedited (15-DaCompany Report #JACGBR2000000756 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Health Div Johnson And Professional Johnson ORAL 2 MG, DAILY, ORAL Thyroxine (Levothyroxine Sodium) C Donepezil (Donepezil) C Diazepam (Diazepam) C 22-Feb-2006 08:20 AM Page: 914 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Citalopram (Citalopram) C Bendrofluazide (Bendroflumethiazide ) C Ferrous Sulphate (Ferrous Sulfate) C Co-Proxamol (Aporex) C Lorazepam (Lorazepam) C Temazepam (Temazepam) C Calciferol (Ergocalciferol) C Date:11/16/00ISR Number: 3612947-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000002573 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Risperdal PS Janssen Research Fdn Hospitalization - Bradycardia Health Div Johnson And Initial or Prolonged Depressed Level Of Professional Johnson ORAL MG, DAILY, Consciousness ORAL Dysphagia Biperiden Hcl Hypothermia (Biperiden Hydrochloride) SS ORAL TABLE, DAILY, ORAL Estazolam (Estazolam) SS ORAL MG, DAILY, ORAL Date:11/16/00ISR Number: 3612956-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000002486 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Risperdal PS Janssen Research Fdn Blood Chloride Decreased Health Div Johnson And Convulsion Professional Johnson ORAL MG, DAILY, Hallucination, Auditory ORAL Hyperhidrosis Chlorpromazine Hyponatraemia Hydrochloride Loss Of Consciousness (Chlorpromazine Mydriasis Hydrochloride) C Water Intoxication Zotepine (Zotepine) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Levomepromazine Maleate (Levomepromazine Maleate) C Flunitrazepam (Flunitrazepam) C Vegetamin A (Vegetamin A) C 22-Feb-2006 08:20 AM Page: 915 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/00ISR Number: 3612981-4Report Type:Expedited (15-DaCompany Report #WAES 00102077 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Prinivil PS Merck Research Initial or Prolonged Hyponatraemia Professional Laboratories Div Polyuria Merck Co Inc ORAL 10 MG/DAILY/PO Risperidone SS ORAL 3 MG/BID/PO Atenolol C Diphenhydramine C Lorazepam C Date:11/16/00ISR Number: 3612997-8Report Type:Expedited (15-DaCompany Report #JACGER2000001734 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Oedema Health Div Johnson And Pleural Effusion Professional Johnson ORAL 0.5 MG, 1 IN Weight Increased 1 DAY(S), ORAL Risperdal (1 Mg/Ml Solution) (Risperidone) C Date:11/16/00ISR Number: 3612998-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000002573 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Risperdal PS Janssen Research Fdn Hospitalization - Bradycardia Health Div Johnson And Initial or Prolonged Cardio-Respiratory Arrest Professional Johnson ORAL MG, DAILY, Depressed Level Of ORAL Consciousness Biperiden Hcl Dysphagia (Biperiden Hypothermia Hydrochloride) SS ORAL TABLET, Pneumonia Aspiration DAILY, ORAL Weight Decreased Estazolam (Estazolam) SS ORAL MG, DAILY, ORAL Date:11/16/00ISR Number: 3613011-0Report Type:Expedited (15-DaCompany Report #00P-056-0099639-00(0) Age:1 DY Gender:Female I/FU:I Outcome PT Hospitalization - Benign Congenital Initial or Prolonged Hypotonia Complications Of Maternal Exposure To Therapeutic Drugs Electroencephalogram Abnormal Feeding Disorder Neonatal Foetal Macrosomia Gastrointestinal Disorder Hypoglycaemia Leukopenia Neonatal Disorder 22-Feb-2006 08:20 AM Page: 916 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premature Baby Sedation Vasodilatation Report Source Product Role Manufacturer Route Dose Duration Foreign Tranxene PS Abbott Laboratories Health Pharmaceutical Professional Products Div Levomepromazine (Levomepromazine) SS Risperidone (Risperidone) SS Haloperidol (Haloperidol) SS Diazepam (Diazepam) SS Date:11/20/00ISR Number: 3614453-XReport Type:Expedited (15-DaCompany Report #JACGER2000001733 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Risperdal PS Janssen Research Fdn Required Complete Health Div Johnson And Intervention to Professional Johnson ORAL MG, DAILY, Prevent Permanent ORAL Impairment/Damage Lithium C L-Thyroxin C Date:11/20/00ISR Number: 3614456-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000002694 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Femoral Neck Fracture Foreign Risperdal 7-Day Hospitalization - Study Starter Pack PS Janssen Research Fdn Initial or Prolonged Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Haldol C Date:11/20/00ISR Number: 3614459-0Report Type:Expedited (15-DaCompany Report #JRFBEL2000002695 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal 7-Day Study Starter Pack PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL DAILY, ORAL Seropram C Date:11/20/00ISR Number: 3614556-XReport Type:Expedited (15-DaCompany Report #JACGBR2000000657 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Glomerulonephritis Foreign Risperdal PS Janssen Research Fdn Hospitalization - Proliferative Health Div Johnson And Initial or Prolonged Professional Johnson ORAL 1.5 MG, 1 IN Disability 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 917 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/00ISR Number: 3614557-1Report Type:Expedited (15-DaCompany Report #JACGER2000001732 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemorrhagic Stroke Foreign Risperdal PS Janssen Research Fdn Lip Disorder Health Div Johnson And Sedation Professional Johnson ORAL 0.5 MG, 1 IN Transient Ischaemic 1 TIME(S) Attack ORAL Digitalis (Digitalis) C Insidon (Opipramol Hydrochloride) C Date:11/20/00ISR Number: 3614914-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000009298 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL 6, DAILY, ORAL Date:11/20/00ISR Number: 3614915-5Report Type:Expedited (15-DaCompany Report #JRFUSA2000005502 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Company Johnson ORAL ORAL Representative Date:11/20/00ISR Number: 3615459-7Report Type:Expedited (15-DaCompany Report #JRFUSA2000009300 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Risperdal PS Janssen Research Fdn Leukopenia Professional Div Johnson And Johnson ORAL 1.5 MG, 1 IN DAILY, ORAL Klonopin C Depakote C Date:11/20/00ISR Number: 3615460-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000009257 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL 2 MG, 1 IN 1 DAY(S), ORAL Clozaril SS ORAL ORAL Zyprexa SS ORAL ORAL Lorazepam C Benztropine C 22-Feb-2006 08:20 AM Page: 918 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/00ISR Number: 3614401-2Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Risperidone PS Required Intervention to Prevent Permanent Impairment/Damage Date:11/21/00ISR Number: 3615433-0Report Type:Direct Company Report # Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sedation Risperidone PS ORAL 2MG/DAY Vision Blurred DECREASED TO 0.75MG/DAY PO Fluoxetine C Divalproex C Folic Acid C Trazodone C Lotrisone C Date:11/21/00ISR Number: 3624342-2Report Type:Periodic Company Report #S00-USA-00890-01 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Health Celexa PS Forest Laboratories Galactorrhoea Professional Inc ORAL 20 MG QD PO Company Celexa (Citalopram) SS ORAL 60 MG QD PO Representative Risperdal (Risperidone) SS ORAL 1.5 MG QD PO Depakote (Valproate Semisodium) C Nortriptyline C Ativan C Date:11/21/00ISR Number: 3627046-5Report Type:Periodic Company Report #S00-USA-01331-01 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hirsutism Health Celexa PS Forest Laboratories Professional Inc Risperdal (Risperidone) SS Date:11/21/00ISR Number: 3627047-7Report Type:Periodic Company Report #S00-USA-01331-02 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hirsutism Health Celexa PS Forest Laboratories Professional Inc Risperdal (Risperidone) SS 22-Feb-2006 08:20 AM Page: 919 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/00ISR Number: 3617647-2Report Type:Expedited (15-DaCompany Report #001-0073-M0000440 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dry Mouth Consumer Dilantin PS Parke Davis Div Initial or Prolonged Epilepsy Warner Lambert Co ORAL 300 MG Extrapyramidal Disorder (DAILY), PER Fall ORAL Foot Fracture Zyprexa(Olanzapine) SS 20 MG (QHS) Grand Mal Convulsion Phenobarbital(Phenob Hallucination arbital) SS ORAL 60 MG Head Injury (DAILY), PER Loss Of Consciousness ORAL Orthostatic Hypotension Luvox(Fluvoxamine Psychotic Disorder Maleate) SS ORAL 25 MG Schizophrenia (DAILY), PER Simple Partial Seizures ORAL Vertigo Valproate(Valproate Bismuth) SS Risperidone(Risperid one) SS Date:11/24/00ISR Number: 3616389-7Report Type:Expedited (15-DaCompany Report #FLUV00200005918 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Consumer Luvox PS Solvay Hospitalization - Aggression Pharmaceuticals ORAL SEE IMAGE Initial or Prolonged Akathisia Risperdal Attention (Risperidone) SS ORAL SEE IMAGE Deficit/Hyperactivity Depakote (Valproate Disorder Semisodium) SS ORAL 500 MG BID Confusional State PO, 750 MG Disorientation DAILY PO Grand Mal Convulsion Zoloft (Sertraline Hyperacusis Hydrochloride) SS ORAL 50 MG DAILY Movement Disorder PO Photophobia Ativan (Lorazepam) C Photosensitivity Reaction Serotonin Syndrome Urinary Incontinence Date:11/24/00ISR Number: 3617213-9Report Type:Expedited (15-DaCompany Report #JACGER2000001759 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn Study Div Johnson And Health Johnson ORAL MG, DAILY, Professional ORAL Tavor C Dihydergot C Date:11/24/00ISR Number: 3617217-6Report Type:Expedited (15-DaCompany Report #JRFBEL2000002660 Age:50 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 920 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Blood Creatine Foreign Risperdal PS Janssen Research Fdn Phosphokinase Increased Health Div Johnson And C-Reactive Protein Professional Johnson ORAL MG, DAILY, Increased ORAL Cystitis Timiperone C Hyperhidrosis Haldol Decanoate C Infection Levomepromazine Pyrexia Maleate C Trihexyphenidyl Hydrochloride C Date:11/24/00ISR Number: 3617220-6Report Type:Expedited (15-DaCompany Report #JRFBEL2000002737 Age:40 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal PS Janssen Research Fdn Coordination Abnormal Health Div Johnson And Diabetes Insipidus Professional Johnson ORAL 4 MG, 2 IN 1 Drug Interaction DAY(S), ORAL Epilepsy Akineton SS ORAL 2 MG, 3 IN 1 Psychiatric Symptom DAY(S), ORAL Thirst Diphantoine C Urinary Incontinence Trileptal C Date:11/24/00ISR Number: 3617222-XReport Type:Expedited (15-DaCompany Report #JRFBEL2000000935 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Conduction Disorder Foreign Risperdal PS Janssen Research Fdn Electrocardiogram Study Div Johnson And Abnormal Health Johnson ORAL 2 MG,1 IN 1 Professional DAY(S), ORAL Date:11/27/00ISR Number: 3621602-6Report Type:Periodic Company Report #PHEH2000US08164 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Health Clozaril PS Novartis Initial or Prolonged Leukopenia Professional Pharmaceuticals Corp ORAL 300 MG, QHS, Pyrexia ORAL Risperdal (Risperidone) SS 35 DAY Trazodone (Trazodone) C Vancenase (Beclometasone Dipropionate) C Atrovent (Ipratropium Bromide) C Nitroglycerin C Aspirin C Vitamin E C Metamucil (Psyllium Hydrophilic 22-Feb-2006 08:20 AM Page: 921 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mucilloid) C Dss C Date:11/27/00ISR Number: 3621605-1Report Type:Periodic Company Report #PHEH2000US01926 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL ORAL Risperdal (Risperidone) (Risperidone) SS ORAL 3 MG, BID, ORAL Haldol C Date:11/27/00ISR Number: 3621977-8Report Type:Periodic Company Report #PHEH2000US09071 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Clozaril PS Novartis Professional Pharmaceuticals Corp ORAL 1000 MG, QD, ORAL Risperdal(Risperidon e) SS Olanzapine(Olanzapin e) C Date:11/27/00ISR Number: 3622166-3Report Type:Periodic Company Report #PHEH1999US04723 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Clozaril PS Novartis Initial or Prolonged Phosphokinase Increased Professional Pharmaceuticals Corp ORAL ORAL Convulsion Risperdal Hyponatraemia (Risperidone) Pyrexia (Risperidone) SS ORAL 3 MG, ORAL Date:11/27/00ISR Number: 3622944-0Report Type:Periodic Company Report #PHEH1999US04459 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Clozaril PS Novartis Hospitalization - Cardiac Failure Professional Pharmaceuticals Corp ORAL 650 MG, ORAL Initial or Prolonged Condition Aggravated Risperdal Other Leukopenia (Risperidone) SS Neutropenia Lithium C Pharyngolaryngeal Pain Cogentin Psychotic Disorder (Benzatropine Pyrexia Mesilate) C Benztropine (Benzatropine) C 22-Feb-2006 08:20 AM Page: 922 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/00ISR Number: 3618123-3Report Type:Direct Company Report # Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Risperidone PS Date:11/29/00ISR Number: 3618724-2Report Type:Direct Company Report # Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Risperdal PS Initial or Prolonged Dysarthria Celexa SS Required Flat Affect Intervention to Hyperhidrosis Prevent Permanent Muscle Rigidity Impairment/Damage Social Avoidant Behaviour Speech Disorder Staring Date:11/29/00ISR Number: 3618786-2Report Type:Expedited (15-DaCompany Report #JRFUSA2000009421 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Bradycardia Literature Risperdal PS Janssen Research Fdn Intervention to Health Div Johnson And Prevent Permanent Professional Johnson ORAL ORAL Impairment/Damage Ssri (Ssri) C Date:11/29/00ISR Number: 3618823-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000002694 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Femoral Neck Fracture Foreign Risperdal PS Janssen Research Fdn Hospitalization - Pulmonary Embolism Study Div Johnson And Initial or Prolonged Health Johnson ORAL MG, DAILY, Professional ORAL Haldol (Unspecified) (Haloperidol) C Date:11/29/00ISR Number: 3618826-0Report Type:Expedited (15-DaCompany Report #JRFBEL2000002695 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Foreign Risperdal PS Janssen Research Fdn Pneumonia Study Div Johnson And Health Johnson ORAL DAILY, ORAL Professional Seropram (Citalopram Hydrobromide) C Date:11/29/00ISR Number: 3618859-4Report Type:Expedited (15-DaCompany Report #JACGBR2000000917 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal PS Janssen Research Fdn Thrombocytopenia Health Div Johnson And Professional Johnson ORAL 1 MG 2 IN 1 DAY(S) ORAL 22-Feb-2006 08:20 AM Page: 923 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3619158-7Report Type:Expedited (15-DaCompany Report #JACGBR2000000567 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abdominal Pain Foreign Risperdal PS Janssen Research Fdn Other Alanine Aminotransferase Health Div Johnson And Increased Professional Johnson 4 MG, 2 IN 1 Blood Viscosity Increased DAY(S), Constipation Diarrhoea Rectal Haemorrhage Date:11/29/00ISR Number: 3619159-9Report Type:Expedited (15-DaCompany Report #JACGBR2000000188 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL ORAL Paroxetine (Paroxetine) SS Date:11/29/00ISR Number: 3619161-7Report Type:Expedited (15-DaCompany Report #JACFRA2000000776 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cleft Palate Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Complications Of Maternal Health Div Johnson And Congenital Anomaly Exposure To Therapeutic Professional Johnson ORAL 2 MG, 1 IN 1 Drugs Company DAY(S), ORAL Micrognathia Representative Urbanyl (Clobazam) SS ORAL ORAL Pierre Robin Syndrome Tongue Disorder Date:11/29/00ISR Number: 3624148-4Report Type:Periodic Company Report #US_000541109 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Study Zyprexa PS Eli Lilly And Co 2.5 MG Initial or Prolonged Health Risperidone SS Professional Paxil C Ativan C Date:11/30/00ISR Number: 3619914-5Report Type:Expedited (15-DaCompany Report #JRFBEL2000002749 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Foreign Haldol PS Rw Johnson Completed Suicide Health Pharmaceutical Dyskinesia Professional Research Institute Div Ortho Pharm Risperidone(Tablet)( Risperidone) SS ORAL DAILY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C 22-Feb-2006 08:20 AM Page: 924 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/00ISR Number: 3619978-9Report Type:Expedited (15-DaCompany Report #JACFRA2000000750 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Disseminated Health Div Johnson And Intravascular Coagulation Professional Johnson ORAL 4 MG, 1 IN 1 Escherichia Infection Company DAY(S) ORAL Extrapyramidal Disorder Representative Tercian Hepatotoxicity (Cyamemazine) SS ORAL DAILY, ORAL Hyperpyrexia Paracetamol Neuroleptic Malignant (Paracetamol) SS ORAL ORAL Syndrome Depamide Urinary Tract Infection (Valpromide) C Laroxyl (Amitriptyline Hydrochloride) C Lepticur (Tropatepine Hydrochloride) C Tocopherol (Tocopherol) C Date:11/30/00ISR Number: 3619996-0Report Type:Expedited (15-DaCompany Report #JACFRA2000000761 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Suicide Attempt Health Div Johnson And Vomiting Professional Johnson ORAL ORAL Seloken (Metoprolol Tartrate) C Kardegic (Acetylsalicylate Lysine) C Date:11/30/00ISR Number: 3619997-2Report Type:Expedited (15-DaCompany Report #JACFRA2000000741 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Confusional State Company Div Johnson And Decreased Activity Representative Johnson ORAL 1 MG, 1 IN 1 Disorientation DAY(S), ORAL Extrapyramidal Disorder Hald0l (1 Mg Tablet) Fall (Haloperidol) SS ORAL MG, DAILY, Pyrexia ORAL Surmontil (Trimipramine) SS ORAL 12.5 , MG, 1 IN 1 DAY(S), ORAL Date:11/30/00ISR Number: 3619998-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000002104 Age:25 YR Gender:Female I/FU:F Outcome PT Hospitalization - Circadian Rhythm Sleep Initial or Prolonged Disorder Circulatory Collapse 22-Feb-2006 08:20 AM Page: 925 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Convulsion Depressed Level Of Consciousness Report Source Product Role Manufacturer Route Dose Duration Electroencephalogram Foreign Risperdal PS Janssen Research Fdn Abnormal Health Div Johnson And Grand Mal Convulsion Professional Johnson ORAL MG, DAILY, Hallucination, Auditory ORAL Headache Biperiden Listless Hydrochloride Malaise (Biperiden) C Persecutory Delusion Haloperidol (Tablet) Screaming (Haloperidol) C Suicidal Ideation Chlorpromazine Urinary Incontinence Hydrochloride (Chlorpromazine Hydrochloride) C Amezinium Metilsulfate (Amezinium Metilsulfate) C Flunitrazepam (Flunitrazepam) C Date:11/30/00ISR Number: 3619999-6Report Type:Expedited (15-DaCompany Report #JACGER2000001773 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Change Foreign Risperdal PS Janssen Research Fdn ORAL MG, DAILY, Initial or Prolonged Sedation Study ORAL Transient Ischaemic Health Melneurin (Melperone Attack Professional Hydrochloride) SS ORAL MG, DAILY, ORAL Fluninoc (Flunitrazepam0 SS ORAL MG, DAILY, ORAL Date:11/30/00ISR Number: 3620034-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000002132 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperdal PS Janssen Research Fdn Gait Disturbance Health Div Johnson And Haemorrhage Professional Johnson ORAL 4 MG, DAILY, Hepatocellular Damage ORAL Nasopharyngitis Haloperidol Pneumonia (Haloperidol) SS ORAL 5 MG, DAILY, Pyrexia ORAL Sudden Death Bromperidol (Bromperidol) SS ORAL 4 MG DAILY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Hydroxyzine Pamoate (Hydroxyzine) C Etizolam (Etizolam) C Propericiazine (Periciazine) C 22-Feb-2006 08:20 AM Page: 926 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/00ISR Number: 3620087-3Report Type:Expedited (15-DaCompany Report #20001100476 Age:69 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Toprol-Xl PS Astrazeneca Intentional Overdose Health Pharmaceuticals Lp Professional Verapamil SS Risperidone SS Date:11/30/00ISR Number: 3620190-8Report Type:Expedited (15-DaCompany Report #JRFUSA2000009515 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Oedema Consumer Risperdal PS Janssen Research Fdn Computerised Tomogram Div Johnson And Abnormal Johnson ORAL 1 MG, 1 IN 1 Feeling Cold DAY(S), ORAL; Feeling Hot 0.5 MG, 1 IN Headache 1 DAY(S), Pain In Extremity ORAL; 0.25 Pyrexia Syncope Tardive Dyskinesia Viral Infection Weight Increased Date:11/30/00ISR Number: 3620437-8Report Type:Expedited (15-DaCompany Report #S00-GER-01905-01 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Foreign Celexa PS Forest Laboratories Initial or Prolonged Health Inc ORAL 20 MG QD PO Professional Cipramil Other (Citalopram) SS ORAL 30 MG QD PO Cipramil (Citalopram) SS ORAL 40 MG QD PO Cipramil (Citalopram) SS ORAL 20 MG QD PO Cipramil (Citalopram) SS ORAL 40 MG QD PO Cipramil (Citalopram) SS ORAL 60 MG QD PO Fluanxol "Lundbeck" (Flupentixol Dihydrachloride) SS ORAL 20 MG QD PO Fluanxol "Lundbeck" (Flupentixol Dihydrochloride) SS ORAL 30 MG QD PO Fluanxol "Lundbech" (Flupentixol Dihydrochloride) SS ORAL 25 MG QD PO Risperdal (Risperidone) SS 2 MG QD Risperdal (Risperidone) SS 4 MG QD Risperdal (Risperidone) SS 6 MG QD Risperdal (Risperidone) SS 4 MG QD Risperdal 22-Feb-2006 08:20 AM Page: 927 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) SS 3 MG QD Risperdal (Risperidone) SS 2 MG QD Haldol (Haloperidol) SS 5 MG QD Haldol (Haloperidol) SS 10 MG QD Haldol (Haloperidol) SS 5 MG QD Haldol (Haloperidol) SS 3 MG QD Haldol (Haloperidol) SS 10 MG QD Haldol (Haloperidol) SS 12.5 MG QD Haldol (Haloperidol) SS 10 MG QD Haldol (Haloperidol) SS 5 MG QD Akineton (Biperiden Hydrochloride) C Trevilor (Venlafaxine Hydrochloride) C Date:12/01/00ISR Number: 3624904-2Report Type:Periodic Company Report #1258681A Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Health Motrin PS Mcneil Consumer Initial or Prolonged Abnormal Professional Healthcare ORAL 2400MG, ONCE, Other Tachycardia PO Risperdal SS ORAL 60 MG, ONCE, PO Rock Of Crack Cocaine SS Date:12/05/00ISR Number: 3621773-1Report Type:Direct Company Report # Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Risperdal 3mg PS ORAL 3MG BID PO Initial or Prolonged Date:12/06/00ISR Number: 3623396-7Report Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Risperidone PS 0.5 MG BID Joint Stiffness AND PRN NTE 4MG/24 HR Nicotine Patch C Effexor C Depakote C Date:12/06/00ISR Number: 3623398-0Report Type:Direct Company Report # Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Galactorrhoea Risperidone PS 0.5MG QD 8/15 - 9/18/00 Trazodone C Claritin C Buprofen C Chlorpromazine C Benztropine C 22-Feb-2006 08:20 AM Page: 928 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/00ISR Number: 3624570-6Report Type:Expedited (15-DaCompany Report #PHEH2000US10152 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Mellaril PS Novartis Hospitalization - Drug Interaction Professional Pharmaceuticals Corp ORAL 50 MG, BID, Initial or Prolonged ORAL Risperdal(Risperidon e) Tablet SS ORAL 1 MG, QHS, ORAL Mellaril C ORAL 75 MG, BID, ORAL Zantac C Vitamin C (Ascorbic Acid) C Lopid C Date:12/07/00ISR Number: 3624572-XReport Type:Expedited (15-DaCompany Report #PHEH2000US10151 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Mellaril PS Novartis Life-Threatening Cardiac Disorder Professional Pharmaceuticals Corp ORAL 200 MG, QD, Hospitalization - Drug Interaction ORAL Initial or Prolonged Fall Risperdal(Risperidon e) Tablet SS ORAL 2 MG, QD, ORAL Prevacid (Lansoprazole) C Acetylsalicylic Acid C Tofranil C Tegretol C Date:12/08/00ISR Number: 3624513-5Report Type:Direct Company Report # Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Wellbutrin Sr PS ORAL 100 MG BID PO Anger Tenex SS ORAL 0.5 MG Q AM Epilepsy PO Headache Risperdal SS ORAL 1 MG Q HS PO Loss Of Consciousness Risperdal SS ORAL 1 MG BID PO Memory Impairment Adderal C Vision Blurred Flonase C Haldol Im C Haldol C Tylenol C Vistaril Im C Vistaril C Maalox C Mom C Date:12/11/00ISR Number: 3626379-6Report Type:Direct Company Report #USP 53475 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Risperdal PS Janssen Requip SS Smithkline Beecham 22-Feb-2006 08:20 AM Page: 929 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/00ISR Number: 3626852-0Report Type:Expedited (15-DaCompany Report #JACGBR2000000955 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL ORAL Company Representative Date:12/11/00ISR Number: 3626853-2Report Type:Expedited (15-DaCompany Report #JAOCAN2000001168 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Risperdal PS Janssen Research Fdn Syncope Health Div Johnson And Ventricular Hypertrophy Professional Johnson ORAL 2 MG, 2 IN 1 Company DAY (S), ORAL Representative Zoloft C Date:12/11/00ISR Number: 3626854-4Report Type:Expedited (15-DaCompany Report #JAOCAN2000001170 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL ORAL Date:12/11/00ISR Number: 3626855-6Report Type:Expedited (15-DaCompany Report #JACGER2000001830 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Risperdal PS Janssen Research Fdn Hospitalization - Phosphokinase Increased Health Div Johnson And Initial or Prolonged Cold Sweat Professional Johnson ORAL DAILY, ORAL Cyanosis Nipolept C Muscle Rigidity Oekolp C Opisthotonus Acetylsalicylic Acid C Pyrexia Shock Date:12/11/00ISR Number: 3626857-XReport Type:Expedited (15-DaCompany Report #JACGER2000001833 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL DAILY, ORAL Stangyl C Diazepam C Date:12/11/00ISR Number: 3626859-3Report Type:Expedited (15-DaCompany Report #JRFBEL2000002573 Age:62 YR Gender:Female I/FU:F Outcome Death Hospitalization - 22-Feb-2006 08:20 AM Page: 930 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Foreign Risperdal PS Janssen Research Fdn Aspiration Health Div Johnson And Bradycardia Professional Johnson ORAL DAILY, ORAL Cardio-Respiratory Arrest Biperiden Hcl C Depressed Level Of Estazolam C Consciousness Dysphagia Hypothermia Pneumonia Weight Decreased Date:12/13/00ISR Number: 3627770-4Report Type:Direct Company Report # Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Risperidone PS Date:12/14/00ISR Number: 3630072-3Report Type:Expedited (15-DaCompany Report #M0886-2000 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Health Remeron PS Organon Inc Sub Increased Professional Akzona Inc ORAL 5 ML IV, THEN Aspartate 30-45 MG PO Aminotransferase Trimipramine SS Increased Risperidone SS Atrioventricular Block Lorazepam SS Blood Alkaline Citalopram C Phosphatase Increased Blood Bilirubin Increased Gamma-Glutamyltransferase Increased Date:12/14/00ISR Number: 3630127-3Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Risperidone PS Date:12/15/00ISR Number: 3631532-1Report Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sinus Arrhythmia Risperidone PS ORAL 1-2 MG PO & M Sinus Bradycardia & 2,G PO PM Nefazodone SS ORAL 300MG PO Sliding Scale Insulin (Regular) C Vitrolente Insulin C Nph Insulin C 22-Feb-2006 08:20 AM Page: 931 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/00ISR Number: 3631742-3Report Type:Expedited (15-DaCompany Report #200021342FR Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Foreign Lasix PS Aventis Hospitalization - Distress Syndrome Other Pharmaceuticals Inc ORAL 1 U/DAY PO Initial or Prolonged Convulsion Cyamemazine Orthostatic Hypotension (Tercian) Solution Shock Nos SS ORAL 100 MG/DAY PO Syncope Ambroxol Vomiting Hydrochloride (Surbronc) SS ORAL 4 U/DAY PO Milnacipran (Ikel) Capsules SS ORAL 100 MG/DAY PO Theophylline (Euphylline L.A.) Capsules SS ORAL 800 MG/DAY PO Risperidone (Risperdal) Tablets SS ORAL 4 MG/DAY PO Date:12/18/00ISR Number: 3632810-2Report Type:Expedited (15-DaCompany Report #NSADSS2000002207 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Health Risperdal PS Janssen Research Fdn ORAL 0.5 MG, 2 IN Initial or Prolonged Professional 1 DAY(S), ORAL Date:12/18/00ISR Number: 3632952-1Report Type:Expedited (15-DaCompany Report #NSADSS2000002048 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Health Risperdal PS Janssen Research Fdn Glaucoma Professional Div Johnson And Intraocular Pressure Johnson ORAL 4 MG, DAILY, Increased ORAL; 1.5 MG, Retinitis Pigmentosa 1IN 1 DAY(S), ORAL Depakote (Valproate Semisodium) C Date:12/18/00ISR Number: 3632953-3Report Type:Expedited (15-DaCompany Report #NSADSS2000002064 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Risperdal(2 Mg Decreased Professional Tablet) (Risperidone) PS Janssen Research Fdn Div Johnson And Johnson ORAL 2 MG, 2 IN 2 DAY(S), ORAL Clozapine(Clozapine) SS ORAL ORAL Depakote(Valproate Semisodium) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 932 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/00ISR Number: 3632955-7Report Type:Expedited (15-DaCompany Report #NSADSS2000002211 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Risperdal(3 Mg Initial or Prolonged Renal Failure Professional Tablet)(Risperidone) PS Janssen Research Fdn Suicidal Ideation Div Johnson And Johnson ORAL 3 MG, 2 IN 1 DAY(S), ORAL Paxil(Paroxetine Hydrochloride) C Date:12/18/00ISR Number: 3633040-0Report Type:Expedited (15-DaCompany Report #PHEH2000US09071 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Clozaril PS Novartis Electrocardiogram Qt Professional Pharmaceuticals Corp ORAL 1000 MG, QD, Prolonged ORAL Overdose Serentil (Mesoridazine) SS Risperdal (Risperidone) SS Olanzapine (Olanzapine) SS Date:12/18/00ISR Number: 3633315-5Report Type:Expedited (15-DaCompany Report #JACFRA2000000803 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Risperdal 7-Day Hypercalcaemia Health Starter Pack PS Janssen Research Fdn Hypernatraemia Professional Div Johnson And Johnson ORAL ORAL Lithium Microsol SS ORAL ORAL Date:12/18/00ISR Number: 3633316-7Report Type:Expedited (15-DaCompany Report #JACGBR2000000958 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL ORAL Date:12/18/00ISR Number: 3633317-9Report Type:Expedited (15-DaCompany Report #JACGER2000001836 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL 0.5 MG, 2 IN Company 1 DAY(S), Representative ORAL 22-Feb-2006 08:20 AM Page: 933 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/00ISR Number: 3633318-0Report Type:Expedited (15-DaCompany Report #JRFBEL2000002798 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Delirium Foreign Risperdal 7-Day Stupor Literature Starter Pack PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL MG, DAILY, ORAL Prednisolone C Vincristine Sulfate C Pirarubicin Hydrochloride C Date:12/18/00ISR Number: 3633319-2Report Type:Expedited (15-DaCompany Report #JACGER2000001734 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Risperdal 7-Day Initial or Prolonged Oedema Health Starter Pack PS Janssen Research Fdn Professional Div Johnson And Johnson ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Risperdal C Date:12/19/00ISR Number: 3633686-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Supraventricular Thorazine PS INTRAMUSCULAR 30 MG IM Tachycardia Risperidone SS ORAL 1 MG PO Ativan C Benadryl C Date:12/20/00ISR Number: 3635047-6Report Type:Expedited (15-DaCompany Report #200021559DE Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Lasix PS Aventis Initial or Prolonged Shock Health Pharmaceuticals Inc ORAL PO 10 DAY Professional Risperidone Other (Risperdal) SS SEE IMAGE Clotiapine (Entumin) SS Atenolol (Tenormin) SS 9 DAY Citalopram Hydrobromide (Seropram) C Sulfamethoxazole, Trimethoprim (Bactrim Forte) C Date:12/21/00ISR Number: 3634639-8Report Type:Direct Company Report # Age:45 YR Gender:Female I/FU:I Outcome Required Intervention to 22-Feb-2006 08:20 AM Page: 934 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Risperdal 1mg Janss PS Janss 2MG PER Osteoporosis Wellburtin C Date:12/22/00ISR Number: 3636141-6Report Type:Expedited (15-DaCompany Report #EMADSS2000002062 Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL 0.5 MG, 2 IN1 DAY(S), ORAL Entumine (Clotiapine) C Date:12/22/00ISR Number: 3636143-XReport Type:Expedited (15-DaCompany Report #EMADSS2000002065 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL 0.5 MG, 2 IN 1 DAY(S), ORAL Calcichew-D3 (Lekovit Ca) C Moduretic (Moduretic) C Antra (Omeprazole) C Date:12/22/00ISR Number: 3636145-3Report Type:Expedited (15-DaCompany Report #JACGBR2000000917 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Foreign Risperdal PS Janssen Research Fdn Hospitalization - Thrombocytopenia Health Div Johnson And Initial or Prolonged Professional Johnson ORAL 1 MG, 2 IN 1 Required DAY(S), ORAL Intervention to Thyroxine Prevent Permanent (Levothyroxine Impairment/Damage Sodium) C Amitriptyline (Amitryltyline) C Aspirin (Acetylsalicylic Acid) C Trimethoprim (Trimethoprim) C Date:12/22/00ISR Number: 3636566-9Report Type:Expedited (15-DaCompany Report #EMADSS2000002052 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Aggression Foreign Initial or Prolonged Insomnia Study 22-Feb-2006 08:20 AM Page: 935 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Product Role Manufacturer Route Dose Duration Haldol PS Rw Johnson Pharmaceutical Research Institute Div Ortho Pharm SEE IMAGE Risperidone (Tablet) (Risperidone) SS SEE IMAGE Date:12/26/00ISR Number: 3635889-7Report Type:Direct Company Report # Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Torsade De Pointes Procainamide (Iv) PS INTRAVENOUS 2MG/MIN IV Risperidone SS ORAL 1MG PO TID Date:12/26/00ISR Number: 3638148-1Report Type:Expedited (15-DaCompany Report #JRFUSA2000000095 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Consumer Risperdal PS Janssen Research Fdn Initial or Prolonged Aggression Health Div Johnson And Required Akathisia Professional Johnson ORAL 3 MG, 7MG, Intervention to Asthenia 6MG, 7.5MG, Prevent Permanent Body Temperature 8.5MG, 1.5MG, Impairment/Damage Decreased 4 IN 1 , 2 IN Bradykinesia 1 DAY(S), Cardiac Arrest Haldol (Tablet) Chest Pain (Haloperidol) SS ORAL 2 MG, 4 IN 1 Convulsion DAY(S), ORAL Drug Effect Decreased Ativan (Lorazepam) SS ORAL 2 MG, 4 IN 1 Drug Withdrawal Syndrome DAY(S), ORAL Headache Olanzapine Hyperhidrosis (Olanzapine) C Memory Impairment Seroquel (Seroquel) C Parkinsonism Zyprexa (Olanzapine) C Pyrexia Remeron Red Blood Cell Count (Mirtazapine) C Decreased Sleep Disorder Suicidal Ideation Tachycardia Tardive Dyskinesia Weight Decreased White Blood Cell Count Decreased Date:12/26/00ISR Number: 3638624-1Report Type:Expedited (15-DaCompany Report #A039421 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Zoloft PS Pfizer Initial or Prolonged Dysarthria Professional Pharmaceuticals Inc ORAL 25.00 MG Required Electroencephalogram TOTAL:DAILY:O Intervention to Abnormal RAL Prevent Permanent Hypotension Risperidal SS ORAL 1.00 MG Impairment/Damage Lethargy TOTAL:DAILY:O 22-Feb-2006 08:20 AM Page: 936 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report RAL Haldol SS INTRAMUSCULAR 4.00 MG TOTAL:PRN:INT RAMUSCULAR Hydrodiuril SS ORAL 25.00 MG TOTAL:DAILY:O RAL Aricept C Levaquin C Ativan C Mellaril C Diovan C Timoptic C Ecotrin C Multivitamin C Vitamin E C Prozac C Date:12/26/00ISR Number: 3639398-0Report Type:Expedited (15-DaCompany Report #EMADSS2000002058 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypothermia Foreign Risperdal PS Janssen Research Fdn Hospitalization - Leukopenia Health Div Johnson And Initial or Prolonged Thrombocytopenia Professional Johnson ORAL 0.5 MG, 3 IN 1 DAILY, ORAL Date:12/26/00ISR Number: 3639400-6Report Type:Expedited (15-DaCompany Report #JACGER2000001836 Age:96 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myelofibrosis Foreign Risperdal PS Janssen Research Fdn Pancytopenia Health Div Johnson And Professional Johnson ORAL 0.5 MG, 2 IN Company 1 DAY, ORAL Representative Captopril (Captopril) C Date:12/26/00ISR Number: 3639401-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000002798 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death B-Cell Lymphoma Foreign Risperdal PS Janssen Research Fdn Catatonia Literature Div Johnson And Delirium Health Johnson ORAL 2 MG, DAILY, Electroencephalogram Professional ORAL; 3 MG, Abnormal DAILY, ORAL; Insomnia 2 MG, DAILY, Normochromic Normocytic ORAL Anaemia Haloperidol Stupor (Haloperidol) C Thrombocytopenia Prednisolone (Prednisolone) C Vincristine Sulfate (Vincristine Sulfate) C Pirarubcin Hydrochloride (Pirarubicin) C 22-Feb-2006 08:20 AM Page: 937 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/00ISR Number: 3638053-0Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Risperdal 3 Mg Intervention to Corrected Interval Janssen PS Janssen ORAL 6MG HS ORAL Prevent Permanent Prolonged Depakote C Impairment/Damage Hypoaesthesia Multivitamin C Calcium Supplement C Date:12/28/00ISR Number: 3638055-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Risperdal 0.5mg Intervention to Corrected Interval Janssen PS Janssen ORAL 0.5 MG QHS Prevent Permanent Prolonged ORAL Impairment/Damage Prozac C Benadryl C Centrum C Benzamycin Gel. C Date:01/02/01ISR Number: 3640451-6Report Type:Expedited (15-DaCompany Report #WAES 00102077 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Prinivil PS Merck Research Hospitalization - Head Injury Professional Laboratories Div Initial or Prolonged Hyponatraemia Merck Co Inc ORAL 10 Other Inappropriate MG/DAILY/PO Antidiuretic Hormone Risperidone SS ORAL 3 MG/BID/PO Secretion Atenolol C Polydipsia Diphenhydramine C Polyuria Lorazepam C Date:01/02/01ISR Number: 3640876-9Report Type:Expedited (15-DaCompany Report #WAES 00102077 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Health Prinivil PS Merck Research Hospitalization - Depressed Level Of Professional Laboratories Div Initial or Prolonged Consciousness Merck Co Inc ORAL 10 MG, DAILY, Other Head Injury PO Hyponatraemia Risperidone SS ORAL 3 MG, BID, PO Polydipsia Atenolol C Polyuria Diphenhydramine C Vomiting Lorazepam C Date:01/02/01ISR Number: 3640907-6Report Type:Expedited (15-DaCompany Report #NSADSS2000002905 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Risperdal PS Janssen Research Fdn Sudden Death Professional Div Johnson And Johnson ORAL 2 MG, 3 IN 1 DAY(S), ORAL Tylenol W/Codeine No. 3 (Tablet) 22-Feb-2006 08:20 AM Page: 938 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Acetaminophen/Codei ne) SS ORAL ORAL Neurontin (Gabapentin) C Date:01/02/01ISR Number: 3640990-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000002486 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Chloride Decreased Foreign Risperdal PS Janssen Research Fdn Blood Potassium Decreased Health Div Johnson And Blood Sodium Decreased Professional Johnson ORAL MG, Convulsion DAILY,ORAL Fall Vegetamin A SS ORAL TABLE, DAILY, Hallucination, Auditory ORAL Hyperhidrosis Chlorpromazine Loss Of Consciousness Hydrochloride C Mydriasis Zotepine C Water Intoxication Biperiden Hydrochloride C Levomepromazine Maleate C Flunitrazepam C Date:01/03/01ISR Number: 3640284-0Report Type:Expedited (15-DaCompany Report #251515 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Rivotril PS Roche THE PATIENT Agitation RECEIVED 10 Cardio-Respiratory Arrest DROPS AT Refusal Of Treatment By NIGHT 2 DAY Relative Clopixol SS Clopixol - Slow Release SS 3 DAY Risperdal SS 3 DAY Nozinan SS Tercian C Depamide C Lepticur C Cannabis C Nozinan C Date:01/03/01ISR Number: 3641599-2Report Type:Expedited (15-DaCompany Report #PHRM2000FR01923 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Anafranil PS Novartis Initial or Prolonged Encephalopathy Health Pharmaceuticals Corp ORAL 112.5 MG/DAY, Hyperhidrosis Professional ORAL Muscle Rigidity Other Risperdal(Risperidon Pyrexia e) SS ORAL 1 DF/DAY, Tremor ORAL Efferalgan (Pacetamol) C Zetril (Lisnopril) Tablet C 22-Feb-2006 08:20 AM Page: 939 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/01ISR Number: 3641646-8Report Type:Expedited (15-DaCompany Report #JACGBR2000000958 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Foreign Risperdal PS Janssen Research Fdn First Degree Health Div Johnson And Brain Scan Abnormal Professional Johnson ORAL 1 MG, 2 IN 1 Cerebral Ischaemia DAY, ORAL; Electrocardiogram 0.5 MG, 2 IN Abnormal 1 DAY, ORAL Myalgia Fluoxetine Myocardial Ischaemia (Fluoxetine) C Date:01/04/01ISR Number: 3640669-2Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Risperdal PS Janssen Pharmaceutica Inc Date:01/04/01ISR Number: 3641825-XReport Type:Expedited (15-DaCompany Report #251515 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Clonopin PS Hoffmann La Roche Agitation Other Inc ORAL 10 DROP DAILY Cardio-Respiratory Arrest ORAL Medication Error Clopixol Refusal Of Treatment By (Zuclopenthixol) SS ORAL 50 DROP 3 PER Patient DAY ORAL Clopixol - Slow Release (Clopenthixol) SS INTRAMUSCULAR 150 MG 1 PER ONE DOSE INTRAMUSCULAR Risperdal (Risperidone) SS ORAL 2 MG DAILY 1 PER DAY ORAL Nozinan (Methotrimeprazine) SS INTRAMUSCULAR 100 MG 2 PER DAY INTRAMUSCULAR Tercian C Depamide C Lepticur C Cannabis C Nozinan C Date:01/04/01ISR Number: 3641922-9Report Type:Direct Company Report # Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Risperdal PS Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:20 AM Page: 940 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/05/01ISR Number: 3641957-6Report Type:Direct Company Report # Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Risperdal 1 + 2 Mg Initial or Prolonged Autonomic Nervous System Tabs PS OTHER 1 MG AM, 2 MG Imbalance HS PER G TUBE Mental Disorder Jevity Plus C Muscle Rigidity Benadryl C Neuroleptic Malignant Colace C Syndrome Sinemet C Date:01/08/01ISR Number: 3642826-8Report Type:Expedited (15-DaCompany Report #00-12-0623 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drooling Health Clozapine PS Zenith Goldline ORAL 225-550MD QD Ovarian Neoplasm Professional ORAL Renal Failure Risperdal Tablets SS ORAL 1MG PO QD Sedation Depakote C Zoloft C Ibuprofen C Amiloride C Date:01/09/01ISR Number: 3644515-2Report Type:Direct Company Report # Age:89 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Risperidal/ Dehydration Risperdal .05 PS ORAL .05 Q PO BID Dysphagia VIA GT MON Eyelid Function Disorder Hyperhidrosis Paralysis Date:01/10/01ISR Number: 3645432-4Report Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sedation Risperdal PS ORAL 2MG PO HS Date:01/10/01ISR Number: 3645575-5Report Type:Expedited (15-DaCompany Report #EMADSS2001000027 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL 0.5 MG, TOTAL, ORAL Fluanxol (Flupentixol) C Oxazepam (Oxazepam) C Sertraline (Sertraline) C ... C 22-Feb-2006 08:20 AM Page: 941 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/10/01ISR Number: 3645667-0Report Type:Expedited (15-DaCompany Report #NSADSS2001000350 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypothermia Health Risperdal PS Janssen Research Fdn Professional Div Johnson And Company Johnson ORAL ORAL Representative Date:01/10/01ISR Number: 3645706-7Report Type:Expedited (15-DaCompany Report #EMADSS2001000033 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Phlebitis Foreign Risperdal PS Janssen Research Fdn Pulmonary Embolism Health Div Johnson And Professional Johnson 1.5 Fluoxetine (Fluoxetine) C Date:01/10/01ISR Number: 3645709-2Report Type:Expedited (15-DaCompany Report #EMADSS2000002111 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Risperdal PS Janssen Research Fdn Hospitalization - Cardiac Arrest Health Div Johnson And Initial or Prolonged Delusion Professional Johnson ORAL 2 MG, 1 IN 1 DAILY, ORAL Clopixol (Zuclopenthixol Decanoate) C Lepticur (Tropatepin E Hydrochloride) C Rivotril (Clonazepam) C Tercian (Cyamemazine) C Nozinan (Levomepromazine) C Date:01/10/01ISR Number: 3653022-2Report Type:Periodic Company Report #000627-SK060 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agitation Consumer Celebrex PS Gd Searle And Co ORAL PO Risperdal SS ORAL 0.750 MG QD PO Advil SS ORAL PO Motrin SS ORAL PO Propranolol Hydrochloride C Date:01/11/01ISR Number: 3646608-2Report Type:Expedited (15-DaCompany Report #01P-056-0101875-00 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Foreign Tranxene PS Abbott Laboratories Initial or Prolonged Health Pharmaceutical Professional Products Div ORAL 40 MG 1 IN 1 22-Feb-2006 08:20 AM Page: 942 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report D PER ORAL Zolpidem (Zolpidem) SS ORAL 10 MG 1 IN 1 D PER ORAL Risperidone (Risperidone) SS ORAL 2 MG 2 IN 1 D PER ORAL Novothyral (Levothyroxine Sodium, Liothyronine Sodium) C Tropatepine Hydrochloride (Tropatepine Hydrochloride) C ORAL PER ORAL Haloperidol (Haloperidol) C Cyamemazine (Cyamemazine) C ORAL 100 MG 1 IN 1 D EPR ORAL Date:01/12/01ISR Number: 3648969-7Report Type:Periodic Company Report #000811-LX831 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Ambien PS Lorex Initial or Prolonged Professional Pharmaceuticals ORAL 30,000 MG PO Risperidone SS IM Hydrocortisone Acetate C Lorazepam C Date:01/16/01ISR Number: 3648227-0Report Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Haloperidol PS OTHER 5MG Q 4 H PRN Speech Disorder Risperidone SS ORAL 1 MG BID Throat Tightness Lithium C Tongue Oedema Melatonin C Multivitamin C Date:01/16/01ISR Number: 3648849-7Report Type:Expedited (15-DaCompany Report #JACFRA2000000588 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Risperdal PS Janssen Research Fdn Required Blood Creatine Health Div Johnson And Intervention to Phosphokinase Increased Professional Johnson ORAL ORAL Prevent Permanent Cardiac Arrest Laroxyl Impairment/Damage Congenital Limb (Amitriptyline Hyperextension Hydrochloride) C Convulsion Theralithe (Lithium Drug Level Above Carbonate) C Therapeutic Equanil Dyskinesia (Meprobamate) C Neuroleptic Malignant Neurontin Syndrome (Gabapentin) C Pyrexia Rivotril Streptococcal Infection (Clonazepam) C 22-Feb-2006 08:20 AM Page: 943 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Imovane (Zopiclone) C Sulfarlem (Anethole Trithione) C Skenan (Morphine Sulfate) C Date:01/16/01ISR Number: 3648850-3Report Type:Expedited (15-DaCompany Report #JACGER2000001773 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Change Foreign Risperdal PS Janssen Research Fdn ORAL MG, DAILY, Initial or Prolonged Sedation Study ORAL Other Health Melneurin (Melperone Professional Hydrochloride) C Fluninoc (Flunitrazepam) C Date:01/16/01ISR Number: 3648851-5Report Type:Expedited (15-DaCompany Report #NSADSS2001000588 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Abscess Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson Company Representative Date:01/16/01ISR Number: 3648879-5Report Type:Expedited (15-DaCompany Report #EMADSS2001000097 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson 0.5 MG, DAILY Tolvon (Mianserin Hydrochloride) C Date:01/18/01ISR Number: 3651124-8Report Type:Periodic Company Report #PRIUSA2000005449 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Weight Increased Consumer Micronor PS Rw Johnson Pharmaceutical Research Institute Div Ortho Pharm ORAL 1, DAILY, ORAL Risperdal SS Synthroid C Prevacid C Depakote C 22-Feb-2006 08:20 AM Page: 944 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/01ISR Number: 3650304-5Report Type:Expedited (15-DaCompany Report #252685 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Rivotril PS Roche Initial or Prolonged Increased Influvac SS 1 DAY Coagulation Factor Vii Sulfarlem SS Level Decreased Deroxat SS Coagulation Factor X Risperdal SS 86 DAY Level Decreased Gutron SS Diarrhoea Eosinophil Count Increased Faecal Incontinence Haemoglobin Decreased Hypoproteinaemia Pemphigoid Platelet Count Decreased Pruritus Red Blood Cell Sedimentation Rate Increased Urinary Incontinence Urticaria Date:01/19/01ISR Number: 3650545-7Report Type:Direct Company Report # Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Lipitor 10mg Qd PS ORAL 10MG PO QD Increased Risperdal SS ORAL 2MG PO BID Aspartate Aminotransferase Increased Blood Creatine Phosphokinase Increased Date:01/19/01ISR Number: 3650644-XReport Type:Direct Company Report # Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Risperidone PS ORAL 4MG,4MG QD Initial or Prolonged Syndrome ORAL Haloperidol Tablet Tab SS ORAL 2MG PO Haloperidol 5mg/Ml Inj, Soln SS INTRAMUSCULAR 2MG,Q4H, PRN , IM Date:01/22/01ISR Number: 3651346-6Report Type:Expedited (15-DaCompany Report #02302 Age:42 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Clonazepam PS Purepac Intentional Overdose Pharmaceutical Co Div Purepac Inc ORAL ORAL Risperidone SS ORAL ORAL Valproic Acid SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 945 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/01ISR Number: 3651349-1Report Type:Expedited (15-DaCompany Report #02336 Age:72 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Clonazepam PS Purepac Intentional Overdose Pharmaceutical Co Div Purepac Inc ORAL ORAL Verapamil SS ORAL ORAL Risperidone SS ORAL ORAL Date:01/22/01ISR Number: 3651423-XReport Type:Direct Company Report # Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lethargy Risperidal PS 2MG QD /OUTPT Initial or Prolonged NH Restoril SS 15MG HS Date:01/22/01ISR Number: 3652276-6Report Type:Expedited (15-DaCompany Report #02262 Age:48 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Trazodone Hcl PS Purepac Intentional Overdose Pharmaceutical Co Div Purepac Inc ORAL ORAL Doxepin SS ORAL ORAL Risperidone SS ORAL ORAL Date:01/22/01ISR Number: 3652365-6Report Type:Expedited (15-DaCompany Report #EMADSS2001000094 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acidosis Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Depressed Level Of Health Div Johnson And Required Consciousness Professional Johnson Intervention to Epilepsy Prevent Permanent Hypernatraemia Impairment/Damage Polyuria Date:01/22/01ISR Number: 3652373-5Report Type:Expedited (15-DaCompany Report #00P-163-0085997-00(1) Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Literature Depakote PS Abbott Laboratories ORAL 500 MG, 2 IN Initial or Prolonged Neutropenia Health 1 D, PER ORAL White Blood Cell Count Professional Risperidone Decreased (Risperidone) SS ORAL PER ORAL Sertraline Hydrochloride (Sertraline Hydrochloride) C 22-Feb-2006 08:20 AM Page: 946 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/01ISR Number: 3652386-3Report Type:Expedited (15-DaCompany Report #EMADSS2001000104 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Haldol PS Rw Johnson Initial or Prolonged Atrial Fibrillation Health Pharmaceutical Blood Pressure Decreased Professional Research Institute Dizziness Risperdal (1 Mg/Ml Dyspnoea Exertional Solution)( Heart Rate Increased Risperidone) SS 2 M., 1 DAILY Insomnia Artane Palpitations (Trihexyphenidyl Hydrochloride) SS Date:01/22/01ISR Number: 3652699-5Report Type:Expedited (15-DaCompany Report #252685 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coagulation Factor Vii Foreign Clonopin PS Hoffmann La Roche Initial or Prolonged Level Decreased Other Inc ORAL 50 DOSE FORM Coagulation Factor X DAILY ORAL Level Decreased Influvac (Influenza Haemoglobin Decreased Virus Vaccine) SS SUBCUTANEOUS 1 DOSE FORM Hypoproteinaemia 1 PER ONE Pemphigoid DOSE Prothrombin Time SUBCUTANEOUS Prolonged Sulfarlem (Anetholtrithion) 25 Mg SS ORAL 1 DOSE FORM 3 PER DAY ORAL Deroxat (Paroxetine) 20 Mg SS ORAL 1 DOSE FORM DAILY ORAL Risperdal (Risperidone) 1 Mg SS ORAL 1 DOSE FORM 3 PER DAY ORAL Gutron (Midodrine Hydrochloride) 25 Mg SS ORAL 7 DOSE FORM DAILY ORAL Date:01/22/01ISR Number: 3652953-7Report Type:Expedited (15-DaCompany Report #NSADSS2001000854 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal PS Janssen Research Fdn Initial or Prolonged Anaemia Div Johnson And Required Road Traffic Accident Johnson ORAL ORAL Intervention to Syncope Prevent Permanent Impairment/Damage Date:01/24/01ISR Number: 3654169-7Report Type:Expedited (15-DaCompany Report #NSADSS2001001163 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Failure Health Risperdal PS Janssen Research Fdn Initial or Prolonged Professional Div Johnson And 22-Feb-2006 08:20 AM Page: 947 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Johnson ORAL ORAL Antipsychotics (Antipsychotics) C Date:01/24/01ISR Number: 3654190-9Report Type:Expedited (15-DaCompany Report #JACFRA2000000776 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Exposure To Therapeutic Health Div Johnson And Congenital Anomaly Drugs Professional Johnson SEE IMAGE Pierre Robin Syndrome Company Urbanyl (Clobazam) SS SEE IMAGE Pregnancy Representative Other Date:01/24/01ISR Number: 3654218-6Report Type:Expedited (15-DaCompany Report #200021342FR Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Foreign Lasix PS Aventis Hospitalization - Hypotension Other Pharmaceuticals Inc ORAL 1 U/DAY PO Initial or Prolonged Respiratory Distress Cyamemazine Shock (Tercian) Solution Vomiting Nos SS ORAL 100 MG/DAY PO Ambroxol Hydrochloride (Surbronc) SS ORAL 4 U/DAY PO Milnacipran (Ixel) Capsules SS ORAL 100 MG/DAY PO Theophylline (Euphylline L.A.) Capsules SS ORAL 800 MG/DAY PO Risperidone (Risperdal) Tablets SS ORAL 4 MG/DAY PO Date:01/24/01ISR Number: 3654529-4Report Type:Expedited (15-DaCompany Report #A044-002-002692 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Aricept PS Eisai Inc ORAL PER ORAL Initial or Prolonged Consciousness Health Risperdal Loss Of Consciousness Professional (Risperidone) SS ORAL PER ORAL Other Cipramil (Citalopriam) C Lasix (Retard Prolonged Release Capsule) (Furosemide) C Folacin (Folacin) C Behepan (Cyanocobalamin) C Kalium Duretter (Potassium Chloride) C Seloken Zok (Metoprolol Succinate) C Trombyl (Acetylsalicylic Acid) C 22-Feb-2006 08:20 AM Page: 948 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/24/01ISR Number: 3654662-7Report Type:Expedited (15-DaCompany Report #S01-SWE-00104-01 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Celexa PS Forest Laboratories Initial or Prolonged Health Inc Professional Aricept (Donepezil Other Hydrochloride) SS Risperdal (Risperidone) SS Lasix Retard (Furosemide) C Folacin C Behepan (Cyanocobalamin) C Kalium Duretter (Potassium Chloride) C Seloken Zoc (Metoprolol Succinate) C Trombyl (Acetysalicylic Acide) C Date:01/25/01ISR Number: 3654202-2Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Risperidol PS Janssen Pharmaceutica Inc Date:01/25/01ISR Number: 3655184-XReport Type:Expedited (15-DaCompany Report #NSADSS2001001367 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Benign Ovarian Tumour Consumer Risperdal PS Janssen Research Fdn Drooling Health Div Johnson And Renal Failure Professional Johnson ORAL ORAL Sedation Topamax SS ORAL ORAL Clozapine SS ORAL 550 MG, DAILY, ORAL Depakote C Amiloride C Ibuprofen C Zoloft C Lisinopril C Date:01/29/01ISR Number: 3656434-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Risperidone Initial or Prolonged (Risperdal/Janssen) PS Janssen ORAL 2MG-BID-PO Divalproex (Depakote/Abbot) SS Abbot ORAL 750 MG-BID-PO 22-Feb-2006 08:20 AM Page: 949 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/01ISR Number: 3657395-6Report Type:Expedited (15-DaCompany Report #A044-002-002692 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Aricept PS Eisai Inc ORAL PER ORAL Initial or Prolonged Health Risperdal Professional (Risperidone) SS ORAL PER ORAL Cipramil (Citalopram) C Lasix (Retard Prolonged Release Capsule) (Furosemide) C Folacin (Folacin) C Behepan (Cyanocobalamin) C Kalium Duretter (Potassium Chloride) C Seloken Zok (Metoprolol Succinate) C Trombyl (Acetylsalicylic Acid) C Date:01/30/01ISR Number: 3656681-3Report Type:Direct Company Report # Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Risperidone PS Urticaria Date:01/30/01ISR Number: 3657916-3Report Type:Expedited (15-DaCompany Report #JAOCAN2000001168 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Risperdal PS Janssen Research Fdn Loss Of Consciousness Health Div Johnson And Syncope Professional Johnson ORAL 2 MG, 2 IN 1 Ventricular Hypertrophy Company DAY(S), ORAL Representative Zoloft (Sertraline Hydrochloride) SS ORAL 100 MG, 1 IN 1 DAY(S), ORAL Date:01/30/01ISR Number: 3659892-6Report Type:Expedited (15-DaCompany Report #NSADSS2001001731 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Mutism Consumer Risperdal PS Janssen Research Fdn Div Johnson And Johnson ORAL 0.5 MG, 2 IN 1 DAY (S), ORAL; 1 MG IN 1 NIGHT (S), ORAL Tylenol W/ Codeine No. 3 C Pamelor C 22-Feb-2006 08:20 AM Page: 950 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trilafon C Solumedrol C Xanax C Ativan C Compazine C Zantac C Mevacor C Capoten C Lasix C Proventil C Prednisone C Restoril C Lomotil C Megace C Tpn C Theodur C Date:01/30/01ISR Number: 3659896-3Report Type:Expedited (15-DaCompany Report #JRFUSA2000006686 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Risperdal PS Janssen Research Fdn Initial or Prolonged Fall Professional Div Johnson And Required Hypercapnia Company Johnson ORAL 1 MG, 2 IN 1 Intervention to Lethargy Representative DAY (S), ORAL Prevent Permanent Lower Respiratory Tract Mellaril Impairment/Damage Infection (Thioridazine Purulence Hydrochloride) SS ORAL 150 MG, 1 IN Respiratory Failure 1 NIGHT (S), Syncope ORAL Lithium C Date:01/31/01ISR Number: 3658137-0Report Type:Periodic Company Report #A0129999A Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Wellbutrin PS Glaxo Wellcome Inc ORAL ORAL Initial or Prolonged Bipolar Disorder Professional Risperidone Crying Other (Risperidone) SS ORAL ORAL Delusion Human Insulin C Depression Alendronate Sodium C Disturbance In Attention Aspirin C Elevated Mood Multivitamin C Fatigue Paracetamol C Ideas Of Reference Ibuprofen C Insomnia Carmellose Sodium C Logorrhoea Mania Pressure Of Speech Psychomotor Hyperactivity Psychotic Disorder Suicidal Ideation Thinking Abnormal 22-Feb-2006 08:20 AM Page: 951 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/01ISR Number: 3659268-1Report Type:Expedited (15-DaCompany Report #EMADSS2001000183 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Clonic Convulsion Foreign Risperdal PS Janssen Research Fdn Hospitalization - Fall Health Div Johnson And Initial or Prolonged Muscle Rigidity Professional Johnson ORAL 1 MG, DAILY, Disability Sedation ORAL Haldol (Haloperidol) C Ceftriaxone (Ceftriaxone) C Morphine (Morphine) C Fraxiparine (Heparin-Fraction, Calcium Salt) C Antra (Omeprazole) C Aspirine Cardio (Acetylsalicylic Acid) C Diclofenac (Diclofenac) C Date:02/01/01ISR Number: 3659269-3Report Type:Expedited (15-DaCompany Report #EMADSS2001000188 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn Thrombocytopenia Health Div Johnson And Professional Johnson ORAL 0.5 MG, DAILY, ORAL Fentanyl (Fentanyl) C Clexane (Heparin-Fraction, Sodium-Salt) C Ampho-Moronal (Amphotericin B) C Tavor (Lorazepam) C Digimerck (Digitoxin) C Antra (Omeprazole) C Acc (Acetylcysteine) C Mst (Morphine Sulfate) C Mst (Morphine Sulfate) C Catapresan (Clonidine) C Disoprivan (Propofol) C Date:02/01/01ISR Number: 3659270-XReport Type:Expedited (15-DaCompany Report #EMADSS2000002111 Age:18 YR Gender:Male I/FU:F Outcome PT Death Abnormal Behaviour Hospitalization - Agitation Initial or Prolonged Blood Pressure Decreased Cardiac Arrest Coma Delusion 22-Feb-2006 08:20 AM Page: 952 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeling Hot Injury Asphyxiation Localised Oedema Report Source Product Role Manufacturer Route Dose Duration Medication Error Foreign Risperdal PS Janssen Research Fdn Mydriasis Health Div Johnson And Pallor Professional Johnson ORAL 2 MG, DAILY, Pulse Absent ORAL Pyrexia Risperdal (2mg Sinus Tachycardia Tablet) (Risperidone) SS ORAL 4 MG, 3 IN 1 DAY(S), ORAL Clopixol (Zuclopenthixol Decanoate) SS PATIENT RECEIVED 150MG Lepticur (Tropatepine Hydrochloride) SS ORAL 10 MG, DAILY, ORAL Rivotril (Clonazepam) SS ON 07-DEC-2000, 20 DROPS Tercian (Cyamemazine) SS 300 MG, DAILY Nozinan (Levomepromazine) SS INTRAMUSCULAR 100 MG (IM) 2X DAY; 12/10 ORAL Date:02/01/01ISR Number: 3659271-1Report Type:Expedited (15-DaCompany Report #EMADSS2001000177 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tendonitis Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Health Div Johnson And Professional Johnson ORAL 1 MG, DAILY, ORAL Cordarone (Amiodarone Hydrochloride) C Bambuterol (Bambuterol) C Aricept (Donepezil Hydrochloride) C Equanil (Meprobamate) C Date:02/01/01ISR Number: 3659272-3Report Type:Expedited (15-DaCompany Report #EMADSS2001000179 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypoglycaemic Coma Foreign Risperdal PS Janssen Research Fdn Health Div Johnson And Professional Johnson ORAL ORAL Peridys (Domperidone) SS ORAL 30 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 953 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Exelon (Rivastigmine) SS ORAL 3 MG, DAILY, ORAL Mopral (Omeprazole) SS ORAL 20 MG, DAILY, ORAL Tercian (Cyamemazine) SS ORAL ORAL Date:02/01/01ISR Number: 3659883-5Report Type:Expedited (15-DaCompany Report #NSADSS2001001866 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Risperdal PS Janssen Research Fdn Hospitalization - Coma Professional Div Johnson And Initial or Prolonged Electrocardiogram Johnson ORAL 2 MG, 2 IN 1 Required Abnormal DAY(S), ORAL; Intervention to Sinus Tachycardia 3 MG, ORAL Prevent Permanent Haldol (Injection) Impairment/Damage (Haloperidol) SS INTRAMUSCULAR 5, IM Ativan (Lorazepam) C Date:02/01/01ISR Number: 3659884-7Report Type:Expedited (15-DaCompany Report #NSADSS2001001942 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cardiac Pacemaker Consumer Risperdal PS Janssen Research Fdn Intervention to Insertion Div Johnson And Prevent Permanent Heart Rate Irregular Johnson ORAL 2 MG, 2 IN Impairment/Damage Neuroleptic Malignant DAILY, ORAL Syndrome Date:02/02/01ISR Number: 3660133-4Report Type:Periodic Company Report #FLUV00200002851 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Luvox PS Solvay Pharmaceuticals ORAL 150 MG BID PO Risperdal (Risperidone) SS ORAL PO Date:02/02/01ISR Number: 3661464-4Report Type:Periodic Company Report #FLUV00200002450 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psoriasis Consumer Luvox (Fluvoxamine Maleate) PS ORAL 100 MG BID PO Risperdal (Risperidone) SS ORAL 3 MG QD PO Effexor (Venlafaxine Hydrochloride) SS ORAL 75 MG TID PO Methotrexate (Methotrexate) SS ORAL DAILY PO 22-Feb-2006 08:20 AM Page: 954 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/01ISR Number: 3661497-8Report Type:Periodic Company Report #FLUV00200006312 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertonia Health Luvox PS Solvay Professional Pharmaceuticals ORAL DAILY PO Company Depakote (Valproate Representative Semisodium) SS ORAL DAILY PO Risperdal (Risperidone) SS ORAL DAILY PO Date:02/05/01ISR Number: 3659324-8Report Type:Expedited (15-DaCompany Report #251515 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Rivotril PS Roche THE PATIENT Agitation RECEIVED 10 Brain Stem Auditory DROPS AT Evoked Response Abnormal NIGHT 2 DAY Cardiac Arrest Clopixol SS THE DOSE WAS Electroencephalogram 50-50-150 BUT Abnormal THE PATIENT Hypotension WOULD HAVE Localised Oedema TAKEN ONLY Loss Of Consciousness Clopixol - Slow Medication Error Release SS 3 DAY Mydriasis Risperdal SS 3 DAY Pallor Nozinan SS 3 DAY Pyrexia Tercian C Respiratory Arrest Depamide C Sinus Tachycardia Lepticur C Cannabis C Nozinan C Date:02/05/01ISR Number: 3661280-3Report Type:Expedited (15-DaCompany Report #2001UW00985 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required White Blood Cell Count Health Seroquel PS Astrazeneca Intervention to Decreased Professional Pharmaceuticals Lp ORAL 200 MG TID PO Prevent Permanent Risperdal SS Impairment/Damage Depakote C Date:02/05/01ISR Number: 3662808-XReport Type:Expedited (15-DaCompany Report #EMADSS2001000217 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Health Haldol (Unspecified) Professional (Haloperidol) SS Lepticur (Tropatepine Hydrochloride) SS Theralene (Alimemazine Tartrate) SS Imovane (Zopiclone) SS Tercian (Cyamemazine) SS 22-Feb-2006 08:20 AM Page: 955 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/01ISR Number: 3663487-8Report Type:Periodic Company Report #PHEH2000US03611 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Other Ritalin Tab PS Novartis Initial or Prolonged Dyskinesia Pharmaceuticals Corp ORAL ORAL Risperidone (Risperidone) Solution, 1.2mg SS ORAL 1.2 MG, QD, ORAL Tegretal (Carbamazepine) C Depakote C Date:02/05/01ISR Number: 3663488-XReport Type:Periodic Company Report #PHEH2000US04072 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Other Ritalin PS Novartis Initial or Prolonged Pharmaceuticals Corp ORAL 20 MG, BID, ORAL 6 MON Risperidone (Risperidone) Tablet SS MG, QD Paxil (Paroxetine Hydrochloride) Tablet, 20 Mg SS ORAL 20 MG, QD, ORAL 6 MON Depakote C Date:02/05/01ISR Number: 3666238-6Report Type:Expedited (15-DaCompany Report #EMADSS2001000440 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eyelid Ptosis Foreign Risperdal (3 Mg Health Tablet) PS Janssen Research Professional Foundation 6 MG, DAILY Lexatin (Bromazepam) SS ORAL 1.5 MG, NIGHT(S), ORAL Date:02/06/01ISR Number: 3662585-2Report Type:Expedited (15-DaCompany Report #251515 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Clonopin PS Hoffmann La Roche Required Agitation Other Inc ORAL 10 DROP DAILY Intervention to Blood Pressure Diastolic ORAL Prevent Permanent Decreased Clopixol Impairment/Damage Cardiac Arrest (Zuclopenthixol) 2% SS ORAL 50 DROP 3 Delusion PER DAY ORAL Electroencephalogram Clopixol - Slow Abnormal Release Injury Asphyxiation (Clopenthixol) 100 Localised Oedema Mg/2ml SS INTRAMUSCULAR 150 MG 1 PER Loss Of Consciousness ONE DOSE Mydriasis INTRAMUSCULAR Pyrexia Risperdal Respiratory Arrest (Risperidone) SS ORAL 2 MG DAILY 1 Sinus Tachycardia PER DAY ORAL 22-Feb-2006 08:20 AM Page: 956 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nozinan (Methotrimeprazine) SS INTRAMUSCULAR 100 MG 2 PER DAY INTRAMUSCULAR Tercian (Cyamemazine) C Depamide (Valpromide) C Lepticur (Tropatepine) C Cannabis (Cannabis) C Nozinan (Methotrimeprazine) C Date:02/07/01ISR Number: 3662326-9Report Type:Expedited (15-DaCompany Report #NSADSS2001001866 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Hospitalization - Electrocardiogram Professional Haldol (Injection) SS Initial or Prolonged Abnormal Ativan (Lorazepam) C Required Electrocardiogram T Wave Intervention to Inversion Prevent Permanent Heart Disease Congenital Impairment/Damage Sinus Tachycardia Date:02/08/01ISR Number: 3662450-0Report Type:Expedited (15-DaCompany Report #EMADSS2001000303 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL 5 MG, 1 IN 1 Health DAILY, ORAL Professional Atorvastatin (Atorvastatin) C Truxal (Chlorprothixene Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Date:02/08/01ISR Number: 3662454-8Report Type:Expedited (15-DaCompany Report #NSADSS2001000588 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Risperdal PS Janssen Research Fdn Meningitis Health Sudden Death Professional Company Representative Date:02/08/01ISR Number: 3662817-0Report Type:Expedited (15-DaCompany Report #NSADSS2001002458 Age:48 YR Gender:Male I/FU:I Outcome PT Death Cardiac Failure Congestive Medication Error 22-Feb-2006 08:20 AM Page: 957 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oedema Peripheral Report Source Product Role Manufacturer Route Dose Duration Health Risperdal PS Janssen Research Fdn ORAL 4 MG 1 IN 1 Professional NIGHT(S), ORAL Date:02/08/01ISR Number: 3662819-4Report Type:Expedited (15-DaCompany Report #NSADSS2001002460 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Disorder Health Risperdal PS Janssen Research Fdn ORAL 3 MG 2 IN Hospitalization - Professional DAILY ORAL Initial or Prolonged Date:02/08/01ISR Number: 3662820-0Report Type:Expedited (15-DaCompany Report #NSADSS2001002465 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Health Risperdal PS Janssen Research Fdn ORAL 3 MG 2 IN 1 Myocardial Infarction Professional DAY(S) ORAL Nasal Congestion Haldol (Injection) (Haloperidol) SS INTRAMUSCULAR 25 MG 1 IN 2 WEEK(S) IM Trazodone (Trazodone) C Cogentin (Benzatropine Mesilate) C Date:02/09/01ISR Number: 3663633-6Report Type:Expedited (15-DaCompany Report #S01-SWE-00104-01 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Celexa PS Forest Laboratories Initial or Prolonged Sedation Health Inc Professional Aricept (Donepezil Other Hydrochloride) SS Risperdal (Risperidone) SS Lasix Retard (Furosemide) C Folacin C Behepan (Cyanocobalamin) C Kalium Duretter (Potassium Chloride) C Seloken Zoc (Metoprolol Succinate) C Trombyl (Acetylsalicylic Acid) C 22-Feb-2006 08:20 AM Page: 958 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/01ISR Number: 3664260-7Report Type:Expedited (15-DaCompany Report #JRFUSA2000000095 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal PS Janssen Research Fdn ORAL 3 MG, 2 IN 1 Initial or Prolonged Akathisia Health DAY(S), ORAL Required Arthralgia Professional ; 7 MG, Intervention to Asthenia DAILY, ORAL ; Prevent Permanent Body Temperature 6 MG, DAILY, Impairment/Damage Decreased Risperdal(Tablet) Bone Marrow Depression (Risperidone) SS ORAL 7.5 MG, Bradykinesia DAILY, ORAL ; Cardiac Arrest 8.5 MG, Chest Pain DAILY, ORAL ; Confusional State 1.5 MG, 4 IN Convulsion Haldol(Tablet) Difficulty In Walking (Haloperidol) SS ORAL 2 MG, 4 IN 1 Drug Withdrawal Syndrome DAY(S), ORAL Dyskinesia Ativan(Lorazepam) SS ORAL 2 MG, 4 IN 1 Headache DAY(S), ORAL Hyperhidrosis Olanzapine C Memory Impairment Seroquel C Parkinsonism Zyprexa(Olanzapine) C Peripheral Coldness Remeron(Mirtazapine) C Psychotic Disorder Pulse Absent Pyrexia Red Blood Cell Count Decreased Sleep Disorder Suicidal Ideation Tachycardia Tardive Dyskinesia Weight Decreased White Blood Cell Count Decreased Date:02/09/01ISR Number: 3664602-2Report Type:Expedited (15-DaCompany Report #EMADSS2001000364 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Potassium Increased Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG, DAILY, Life-Threatening Depressed Level Of Health ORAL Consciousness Professional Ecazide (Capozide) C Extrapyramidal Disorder Glucophage Hypothermia (Metformin Renal Failure Acute Hydrochloride) C Renal Failure Chronic Lasilix (Furosemide) C Digoxine (Digoxin) C Triatec (Ramipril) C Date:02/09/01ISR Number: 3664603-4Report Type:Expedited (15-DaCompany Report #EMADSS2001000368 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Risperdal PS Janssen Research Fdn DAILY DOSE 1 Haemorrhagic Stroke Health TO 3 MG. Professional Propranolol (Propranolol) C 22-Feb-2006 08:20 AM Page: 959 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/01ISR Number: 3664604-6Report Type:Expedited (15-DaCompany Report #EMADSS2001000379 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Angiopathy Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG, ORAL Hemiplegia Health Piracetam Professional (Piracetam) C Enelbin Retard (Naftidrofuryl Oxalate) C Tebokan (Ginkgo Tree Leaves Extract) C Tiapridal (Tiapride) C Date:02/09/01ISR Number: 3664605-8Report Type:Expedited (15-DaCompany Report #JRFBEL2000000279 Age:27 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG, 3 IN 1 Drug Level Above Health DAY (S), ORAL Therapeutic Professional Flunitrazepam Intentional Overdose (Flunitrazepam) SS ORAL 1 MG, 1 IN 1 Loss Of Consciousness NIGHT (S), Pallor ORAL Pulmonary Oedema Date:02/12/01ISR Number: 3664038-4Report Type:Periodic Company Report #HQ5936716MAY2000 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Health Effexor PS Wyeth Ayerst Professional Laboratories ORAL SEE IMAGE Risperdal (Risperidone) SS ORAL 2 MG 1X PER 1 DAY, ORAL Date:02/12/01ISR Number: 3664101-8Report Type:Periodic Company Report #HQ0470113JAN2000 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Health Effexor PS Wyeth Ayerst Initial or Prolonged Inappropriate Professional Laboratories 100 MG TWICE Other Antidiuretic Hormone DAILY Secretion Risperidone (Risperidone) SS 2 MG TWICE DAILY Albuterol (Salbutamol) C Acetaminophen (Paracetamol) C Diphenhydramine (Diphenhydramine Hydrochloride) C Doss (Dantron/Docusate Sodium) C 22-Feb-2006 08:20 AM Page: 960 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/12/01ISR Number: 3664341-8Report Type:Expedited (15-DaCompany Report #EMADSS2001000104 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Risperdal PS Janssen Research Fdn ORAL 2 ML 1 DAILY Initial or Prolonged Atrial Fibrillation Health ORAL Dizziness Professional Artane Dyspnoea Exertional (Trihexyphenidyl Insomnia Hdyrochloride) C Palpitations Haldol (Haloperidol) C Ventricular Tachycardia Date:02/12/01ISR Number: 3668961-6Report Type:Periodic Company Report #JAUSA37120 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Dyskinesia Depakote (Valproate Injury Sodium) C Sedation Zyprexa (Olanzapine) C Tremor Cogentin (Benzatropine Mesilate) C Ativan (Lorazepam) C Date:02/12/01ISR Number: 3668969-0Report Type:Periodic Company Report #JRFUSA2000008051 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Health Risperdal PS Janssen Research Fdn ORAL 0.5 MG, 2 IN Initial or Prolonged Diarrhoea Professional 1 DAY(S), Dizziness ORAL Dystonia Benadryl Faecal Incontinence (Diphenhydramine Salivary Hypersecretion Hydrochloride) C Urinary Incontinence Ritalin (Methylphenidate Hydrochloride) C Date:02/14/01ISR Number: 3665455-9Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dystonia Risperidone PS ORAL 1MG QHS ORAL Date:02/14/01ISR Number: 3666237-4Report Type:Expedited (15-DaCompany Report #JRFBEL2000002189 Age:23 YR Gender:Male I/FU:F Outcome PT Life-Threatening Aspartate Hospitalization - Aminotransferase Initial or Prolonged Increased Disability Blood Creatine Required Phosphokinase Mb Intervention to Increased Prevent Permanent Blood Pressure Diastolic Impairment/Damage Decreased Malnutrition 22-Feb-2006 08:20 AM Page: 961 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paralysis Renal Impairment Rhabdomyolysis Report Source Product Role Manufacturer Route Dose Duration Stress Foreign Risperidone (Tablet) PS Janssen Research Thirst Health Foundation ORAL 2 MG, DAILY, Professional ORAL Luvox (Fluvoxamine Maleate) C Prochlorperazine Maleate C Biperiden Hydrochloride C Date:02/14/01ISR Number: 3666880-2Report Type:Expedited (15-DaCompany Report #01P-056-0103095-00 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Status Epilepticus Foreign Tranxene (Tranxene) Initial or Prolonged Temporal Lobe Epilepsy Health (Clorazepate Professional Dipotassium) PS ORAL PER ORAL Peridone (Risperidone) SS Date:02/16/01ISR Number: 3667396-XReport Type:Expedited (15-DaCompany Report #PHEH2001US01470 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicidal Ideation Consumer Ritalin Initial or Prolonged Weight Increased (Methylphenidate Hydrochloride) PS ORAL ORAL Risperdal (Risperidone) SS ORAL 1) 0.5 MG, TID, ORAL; 2) 2.5 MG, QD, ORAL Ddavp (Desmopressin) C Zoloft (Sertraline Hydrochloride) C Buspar (Buspirone Hydrochloride) C Date:02/16/01ISR Number: 3667939-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000008903 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Glaucoma Health Risperdal Professional (Unspecified) Company (Risperidone) PS Janssen Research Fdn ORAL 3 MG, 2 IN 1 Representative DAY(S), ORAL Trazodone (Trazodone) C Vitamin E (Tocopherol) C Benadryl (Diphenhydramine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 962 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/01ISR Number: 3668220-1Report Type:Expedited (15-DaCompany Report #EMADSS2001000267 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Risperdal PS Janssen Research Fdn 0.5 - 1 M1 Parkinson'S Disease Health DAILY Professional Madopar C Date:02/20/01ISR Number: 3667876-7Report Type:Expedited (15-DaCompany Report #EMADSS2001000450 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Coordination Abnormal Foreign Risperdal PS Janssen Research Fdn DAILY DOSE 1 Drooling Health ML OF 1 Dysarthria Professional MG/5ML Muscle Rigidity Ritalin Strabismus (Methylphenidate Hydrochloride) C Date:02/20/01ISR Number: 3667878-0Report Type:Expedited (15-DaCompany Report #EMADSS2001000580 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG, 2 IN 1 Decreased Health DAY(S), ORAL Professional Date:02/21/01ISR Number: 3668697-1Report Type:Expedited (15-DaCompany Report #A102763 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Zoloft Tablets PS Pfizer Initial or Prolonged Aggression Professional Pharmaceuticals Inc Required Agitation Risperdal SS Intervention to Akathisia Prolixin SS Prevent Permanent Attention Paxil C Impairment/Damage Deficit/Hyperactivity Ativan C Disorder Cognitive Disorder Confusional State Difficulty In Walking Extrapyramidal Disorder Fall Fatigue Gait Disturbance Hallucination, Visual Hearing Impaired Medication Error Memory Impairment Mental Impairment Sedation Sleep Disorder Speech Disorder Tremor 22-Feb-2006 08:20 AM Page: 963 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3668844-1Report Type:Expedited (15-DaCompany Report #A100663 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Zoloft Tablets PS Pfizer Initial or Prolonged Erectile Dysfunction Professional Pharmaceuticals Inc ORAL 200.00 MG Other Priapism TOTAL; DAILY; Required ORAL Intervention to Risperidone SS ORAL 1.00 MG Prevent Permanent TOTAL; DAILY; Impairment/Damage ORAL Depakote C Dilantin C Lipitor C Promethazine C Synthroid C Singulair C Date:02/21/01ISR Number: 3668928-8Report Type:Periodic Company Report #PHEH2001US00582 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Exelon PS Novartis Initial or Prolonged Convulsion Professional Pharmaceuticals Corp ORAL 6 MG, BID, Salivary Hypersecretion ORAL Sedation Risperidal (Risperidone) SS ORAL ORAL Citalopram (Citalopram) C Date:02/21/01ISR Number: 3668953-7Report Type:Periodic Company Report #JRFUSA2000008622 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Risperdal PS Janssen Research Fdn ORAL 1 MG, 2 IN 1 Initial or Prolonged Condition Aggravated Professional DAY (S), ORAL Weight Increased Depakote (Valproate Semisodium) C Ativan (Lorazepam) C Date:02/21/01ISR Number: 3668954-9Report Type:Periodic Company Report #JRFUSA2000008624 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal PS Janssen Research Fdn ORAL 2 MG, 2 IN 1 Initial or Prolonged Weight Increased Professional DAY (S), ORAL Lithium (Lithium) C Trazodone (Trazodone) C Activan (Lorazepam) C Tegretal (Carbamazepine) C Cogentin (Benzatropine Mesilate) C 22-Feb-2006 08:20 AM Page: 964 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3668955-0Report Type:Periodic Company Report #JRFUSA2000008627 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal PS Janssen Research Fdn ORAL 2 MG, 2 IN 1 Initial or Prolonged Weight Increased Professional DAY (S), ORAL Ativan (Lorazepam) C Restoril (Temazepam) C Cpgentin (Benzatropine Mesilate) C Tegretol (Carbamazepine) C Depakote (Valproate Semisodium) C Inderal (Propranolol Hydrochloride) C Lithium (Lithium) C Date:02/21/01ISR Number: 3668956-2Report Type:Periodic Company Report #JRFUSA2000008628 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Health Risperdal PS Janssen Research Fdn ORAL 3 MG, 2 IN 1 Initial or Prolonged Weight Increased Professional DAY (S) , ORAL Date:02/21/01ISR Number: 3668957-4Report Type:Periodic Company Report #JRFUSA2000008898 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Neoplasm Foreign Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Thinking Abnormal Consumer Date:02/21/01ISR Number: 3668958-6Report Type:Periodic Company Report #JRFUSA2000009081 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Risperdal PS Janssen Research Fdn ORAL 6, DAILY, Initial or Prolonged Professional ORAL Date:02/21/01ISR Number: 3668959-8Report Type:Periodic Company Report #JAUSA36375 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal PS Janssen Research Fdn Initial or Prolonged Depersonalisation Zoloft (Sertraline) C Clozaril (Clozapine) C Lescol (Fluvastatin) C Prilosec (Omeprazole) C 22-Feb-2006 08:20 AM Page: 965 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3668960-4Report Type:Periodic Company Report #JAUSA36406 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Albumin Globulin Ratio Haldol (Haloperidol) C Abnormal Haldol Decanoas Back Pain (Haloperidol Condition Aggravated Decaonate) C Depression Drug Abuser Fatigue Fibroadenoma Of Breast Galactorrhoea Headache Pain Paranoia Sedation Suicide Attempt Vomiting Weight Increased Date:02/21/01ISR Number: 3668962-8Report Type:Periodic Company Report #JRFUSA1999000190 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Alopecia Haldol (Tablet) Anxiety (Haloperidol) SS ORAL ORAL Condition Aggravated Zinc (Zinc) C Convulsion Coordination Abnormal Dermatitis Dystonia Gastrointestinal Disorder Headache Hepatocellular Damage Herpes Zoster Hypersensitivity Hypertension Injury Insomnia Muscular Weakness Sedation Tachycardia Thinking Abnormal Date:02/21/01ISR Number: 3668963-XReport Type:Periodic Company Report #JRFUSA2000006734 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Pain Consumer Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Condition Aggravated Health Luvox (Fluvoxamine Required Fatigue Professional Maleate) C Intervention to Hyperprolactinaemia Pamelor Prevent Permanent Pituitary Tumour Benign (Nortriptyline Impairment/Damage Hydrochloride) C 22-Feb-2006 08:20 AM Page: 966 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3668964-1Report Type:Periodic Company Report #JRFUSA2000006969 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Disorder Consumer Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Hypotension Risperdal SS Sedation Haldol (Unspecified) (Haloperdiol) C Cardizem (Diltiazem Hydrochloride) C Xanax (Alprazolam) C Inderal (Propranolol Hydrochloride) C Pepcid (Famotidine) C Date:02/21/01ISR Number: 3668965-3Report Type:Periodic Company Report #JRFUSA2000007073 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Neuroleptic Malignant Professional Olanzapine Required Syndrome (Olanzapine) SS ORAL 10 MG, 1 IN 1 Intervention to NIGHT(S), Prevent Permanent ORAL Impairment/Damage Lithium (Lithium) C Zoloft (Sertraline Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:02/21/01ISR Number: 3668966-5Report Type:Periodic Company Report #JRFUSA2000007162 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Consumer Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Attention Luvox (Fluvoxamine Deficit/Hyperactivity Maleate) SS Disorder Depakote (Valproate Confusional State Semisodium) SS ORAL ORAL Convulsion Zoloft (Sertraline Dyskinesia Hydrochloride) SS Photosensitivity Reaction Ativan (Lorazepam) C Date:02/21/01ISR Number: 3668967-7Report Type:Periodic Company Report #JRFUSA2000007421 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Risperdal PS Janssen Research Fdn ORAL 0.5 MG, 1 IN Initial or Prolonged Tongue Paralysis Professional 1 DAY(S), ORAL Premarin (Estrogens Conjugated) C Lansoprazole (Lansoprazole) C Thyroid Replacement (Thyroid Prep Unsp) C 22-Feb-2006 08:20 AM Page: 967 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3668968-9Report Type:Periodic Company Report #JRFUSA2000007789 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Consumer Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Deficit/Hyperactivity Risperdal SS Disorder Zoloft (Sertraline Condition Aggravated Hydrochloride0 SS ORAL ORAL Sedation Remeron (Mirtazapine) SS ORAL ORAL Coumadin (Warfarin Sodium) C Diabeta 2 C Lotensin (Benzaepril Hydrochloride) C Premarin (Estrogens Conjugated) C Vitamin B12 (Cyanocobalamin) C Lanoxin (Digoxin) C Cardizem (Diltiazem Hydrochloride) C Miralax (Macrogol) C Konsyl (Psyllium Hydrophilic Mucilloid) C Inhaler, Nos (Inhalant Unspec.) C Date:02/21/01ISR Number: 3668970-7Report Type:Periodic Company Report #JRFUSA2000008198 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Health Risperdal PS Janssen Research Fdn ORAL 2 MG, 2 IN 1 Initial or Prolonged Deficit/Hyperactivity Professional DAY(S), ORAL Disorder Clonidine Tardive Dyskinesia (Clonidine) C Vitamins (Vitamins) C Date:02/21/01ISR Number: 3668971-9Report Type:Periodic Company Report #JRFUSA2000008330 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Risperdal PS Janssen Research Fdn ORAL 4 MG, 1 IN 1 Initial or Prolonged Professional NIGHT(S), ORAL Celexa (Citalopram Hydrobromide) C Trazodone (Trazodone) C Monopril (Fosinopril Sodium) C Glyburide (Glibenclamide) C 22-Feb-2006 08:20 AM Page: 968 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3668972-0Report Type:Periodic Company Report #JRFUSA2000008363 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Urea Decreased Health Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Hepatic Function Abnormal Professional Paxil (Paroxetine Hyponatraemia Hydrochloride) C Leukocytosis Neuroleptic Malignant Syndrome Sinusitis Thrombocythaemia Date:02/21/01ISR Number: 3668973-2Report Type:Periodic Company Report #JRFUSA2000004668 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal PS Janssen Research Fdn ORAL 3.5 MG, Initial or Prolonged Agitation DAILY, ORAL Confusional State Hytrin (Terazosin Hypertension Hydrochloride) C Tremor Lisinopril (Lisinopril) C Trental (Pentoxifylline) C Asa (Acetylsalicylic Acid) C Benadryl (Diphenhydramine Hydrochloride) C Diuril (Chlorothiazide) C Lopressor (Metoprolol Tartrate) C Quinine (Quinine) C Synthroid (Levothyroxine Sodium) C Date:02/21/01ISR Number: 3668974-4Report Type:Periodic Company Report #JRFUSA2000004698 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Retention Consumer Risperdal PS Janssen Research Fdn ORAL 1 MG, 3 IN 1 Initial or Prolonged DAY (S), ORAL Isosorbide (Isosorbide) C Imdur (Isosorbinde Mononitrate) C Coumadin (Warfarin Sodium) C Date:02/21/01ISR Number: 3668975-6Report Type:Periodic Company Report #JRFUSA2000004756 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged 22-Feb-2006 08:20 AM Page: 969 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3668976-8Report Type:Periodic Company Report #JRFUSA2000004758 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Risperdal PS Janssen Research Fdn ORAL 3 MG, 1 IN 1 Initial or Prolonged Visual Disturbance DAY (S), ORAL Prozac (Fluoxetine Hydrochloride) C Depakote (Valproate Semisodium) C Date:02/21/01ISR Number: 3668977-XReport Type:Periodic Company Report #JRFUSA2000004784 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Consumer Risperdal PS Janssen Research Fdn ORAL 4 MG, 2 IN 1 Initial or Prolonged Condition Aggravated DAY (S), ORAL Constipation Zoloft (Sertraline Hyperhidrosis Hydrochloride) C Suicide Attempt Buspar (Buspirone Urinary Incontinence Hydrochloride) C Loxitane (Loxapine Succinate) C Klonopin (Clonazepam) C Neurontin (Gabapentin) C Ambien (Zolpidem Tartrate) C Trazodone (Trazodone) C Celebrex (Celecoxib) C Desyrel (Trazodone Hydrochloride) C Date:02/21/01ISR Number: 3668978-1Report Type:Periodic Company Report #JRFUSA2000005192 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaphylactic Shock Health Risperdal PS Janssen Research Fdn ORAL 2 MG, 1 IN 1 Initial or Prolonged Professional DAY (S), ORAL Celexa (Citalopram Hydrobromide) C Date:02/21/01ISR Number: 3668979-3Report Type:Periodic Company Report #JRFUSA2000005459 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Cystitis Restoril (Temazepam) C Diabetes Mellitus Hypertonia Infection Injury Skin Ulcer Tremor Urinary Incontinence 22-Feb-2006 08:20 AM Page: 970 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3668980-XReport Type:Periodic Company Report #JRFUSA2000006101 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Consumer Risperdal PS Janssen Research Fdn ORAL 0;5 MG, 3 IN Initial or Prolonged Sedation Health 1 DAY (S), Professional ORAL Effexor Xr (Venlafaxine Hydrochloride) SS ORAL 75 MG, 2 IN 1 DAY (S), ORAL Paxil (Paroxetine Hydrochloride) C Date:02/21/01ISR Number: 3668981-1Report Type:Periodic Company Report #JRFUSA2000006568 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Professional Company Representative Date:02/21/01ISR Number: 3668982-3Report Type:Periodic Company Report #JRFUSA2000006686 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal PS Janssen Research Fdn ORAL 1 MG, 2 IN 1 Initial or Prolonged Professional DAY (S), ORAL Company Mellaril Representative (Thioridazine Hydrochloride) C Date:02/21/01ISR Number: 3668983-5Report Type:Periodic Company Report #JRFUSA2000003665 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Attention Consumer Risperdal PS Janssen Research Fdn ORAL 3 MG, 1 IN 1 Initial or Prolonged Injury DAY (S), ORAL Prozac (Fluoxetine Hydrochloride) C Date:02/21/01ISR Number: 3668984-7Report Type:Periodic Company Report #JRFUSA2000003879 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Photosensitivity Reaction Consumer Risperdal PS Janssen Research Fdn ORAL 1.5 MG, 2 IN Initial or Prolonged 1 DAY (S), ORAL Tegretol (Carbamazepine) C 22-Feb-2006 08:20 AM Page: 971 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3668985-9Report Type:Periodic Company Report #JRFUSA2000004065 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Risperdal PS Janssen Research Fdn ORAL 4 MG, 2 IN 1 Initial or Prolonged Professional DAY (S), ORAL Other Required Intervention to Prevent Permanent Impairment/Damage Date:02/21/01ISR Number: 3668986-0Report Type:Periodic Company Report #JRFUSA2000004236 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Risperdal PS Janssen Research Fdn ORAL 3 MG, 1 IN 1 Initial or Prolonged Professional DAY (S), ORAL Depakote (Valproate Semisodium) C Clozaril (Clozapine) C Remeron (Mirtazapine) C Cogentin (Benzatropine Mesilate) C Ativan (Lorazepam) C Date:02/21/01ISR Number: 3668987-2Report Type:Periodic Company Report #JRFUSA2000004238 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Health Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Professional Date:02/21/01ISR Number: 3668988-4Report Type:Periodic Company Report #JRFUSA2000004352 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Health Risperdal PS Janssen Research Fdn ORAL 3 MG , 1 IN 1 Initial or Prolonged Professional DAY (S), ORAL Lithium (Lithium) C Date:02/21/01ISR Number: 3668989-6Report Type:Periodic Company Report #JRFUSA2000004408 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen Research Fdn ORAL 3 MG, 2 IN 1 Initial or Prolonged DAY (S), ORAL Date:02/21/01ISR Number: 3668990-2Report Type:Periodic Company Report #JRFUSA2000004411 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged 22-Feb-2006 08:20 AM Page: 972 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3668991-4Report Type:Periodic Company Report #JRFUSA2000004485 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Influenza Like Illness Consumer Risperdal PS Janssen Research Fdn ORAL 3 MG, 2 IN 1 Initial or Prolonged DAY (S), ORAL Buspar (Buspirone Hydrochloride) C Serzone (Nefazodone Hydrochloride) C Date:02/21/01ISR Number: 3668992-6Report Type:Periodic Company Report #JRFUSA2000004664 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen Research Fdn ORAL 1 MG, 2 IN 1 Initial or Prolonged DAY (S), ORAL Adderall (Obetrol) C Seroquel (Seroquel) C Cogentin (Benzatropine Mesilate) C Dexedrine (Dexamfetamine Sulfate) C Date:02/21/01ISR Number: 3668993-8Report Type:Periodic Company Report #JRFUSA2000002628 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Date:02/21/01ISR Number: 3668994-XReport Type:Periodic Company Report #JRFUSA2000002634 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Risperdal PS Janssen Research Fdn ORAL DAILY, ORAL Initial or Prolonged Muscle Relaxants (Muscle Relaxants) C Motrin (Ibuprofen) C Date:02/21/01ISR Number: 3668995-1Report Type:Periodic Company Report #JRFUSA2000002656 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cough Health Risperdal PS Janssen Research Fdn ORAL 8 MG, DAILY, Oedema Professional ORAL; 2 MG, 1 Urinary Incontinence IN 1 DAY (S), Weight Increased ORAL Lithium (Lithium) C Allopurinol (Allopurinol) C Atenolol (Atenolol) C 22-Feb-2006 08:20 AM Page: 973 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3668996-3Report Type:Periodic Company Report #JRFUSA2000002754 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ketoacidosis Health Risperdal PS Janssen Research Fdn 8 MG,DAILY, Initial or Prolonged Professional ORAL Prozac C Cogentin C Reglan C Prilosec C Date:02/21/01ISR Number: 3668997-5Report Type:Periodic Company Report #JRFUSA2000003138 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Risperdal PS Janssen Research Fdn ORAL 2 MG, 2 IN 1 Initial or Prolonged Headache DAY (S), ORAL Sexual Dysfunction Weight Increased Date:02/21/01ISR Number: 3668998-7Report Type:Periodic Company Report #JRFUSA2000003274 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Remeron (Mirtazapine) C Date:02/21/01ISR Number: 3668999-9Report Type:Periodic Company Report #JRFUSA2000003320 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Health Risperdal PS Janssen Research Fdn ORAL 6 MG, DAILY, Initial or Prolonged Professional ORAL; (SEE Required IMAGE) Intervention to Lithium (Lithium) C Prevent Permanent Valproic Acid Impairment/Damage (Valproic Acid) C Benzotropine (Benzotropine) C Date:02/21/01ISR Number: 3669000-3Report Type:Periodic Company Report #JRFUSA2000003369 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Date:02/21/01ISR Number: 3669001-5Report Type:Periodic Company Report #JRFUSA2000003603 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Risperdal PS Janssen Research Fdn ORAL 3 MG, 1 IN 1 Initial or Prolonged Professional DAY (S), ORAL 22-Feb-2006 08:20 AM Page: 974 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3669002-7Report Type:Periodic Company Report #JRFUSA2000003610 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Risperdal PS Janssen Research Fdn ORAL 3 MG, 1 IN 1 Initial or Prolonged Professional DAY (S), ORAL Date:02/21/01ISR Number: 3669003-9Report Type:Periodic Company Report #JRFUSA2000001095 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Risperdal PS Janssen Research Fdn ORAL 1 MG, 3 IN 1 Initial or Prolonged DAY(S), ORAL Neurontin (Gabapentin) C Cogentin (Benzatropine Mesilate) C Wellbutrin (Amfebutamone Hydrochloride) C Zyprexa (Olanzapine) C Date:02/21/01ISR Number: 3669004-0Report Type:Periodic Company Report #JRFUSA2000001298 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Date:02/21/01ISR Number: 3669005-2Report Type:Periodic Company Report #JRFUSA2000001403 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Hyponatraemia Professional Haldol Decanoate Required (Injection) Intervention to (Haloperidol Prevent Permanent Decanoate) SS INTRAMUSCULAR 100 MG, 1 IN Impairment/Damage 2 WEEK(S), IM Cogentin (Benzatropine Mesilate) C Date:02/21/01ISR Number: 3669006-4Report Type:Periodic Company Report #JRFUSA2000001574 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal PS Janssen Research Fdn ORAL 0.5 MG, 1 IN Initial or Prolonged 1 DAY(S), ORAL Ritalin (Methylphenidate Hydrochloride) C 22-Feb-2006 08:20 AM Page: 975 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3669007-6Report Type:Periodic Company Report #JRFUSA2000001856 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Date:02/21/01ISR Number: 3669008-8Report Type:Periodic Company Report #JRFUSA2000001949 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Date:02/21/01ISR Number: 3669009-XReport Type:Periodic Company Report #JRFUSA2000001990 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Mania Health Risperdal SS Sedation Professional Risperdal SS Wellbutrin (Amfebutamone Hydrochloride) SS ORAL ORAL Humulin Insulin 70/30 (Humulin 70/30) C Fosamax (Alendronate Sodium) C Aspirin (Acetylsalicylic Acid) C Multivitamin (Multiple Vitamins) C Acetaminophen (Paracetamol) C Motrin (Ibuprofen) C Celluvisc (Celluvisc) C Date:02/21/01ISR Number: 3669010-6Report Type:Periodic Company Report #JRFUSA2000002215 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Date:02/21/01ISR Number: 3669011-8Report Type:Periodic Company Report #JRFUSA2000002255 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal PS Janssen Research Fdn ORAL 8 MG, DAILY, Initial or Prolonged Syndrome Professional ORAL Required Prozac (Fluoxetine Intervention to Hydrochloride) C Prevent Permanent Cogentin Impairment/Damage (Benzatropine Mesilate) C 22-Feb-2006 08:20 AM Page: 976 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3669012-XReport Type:Periodic Company Report #JRFUSA2000002595 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amenorrhoea Health Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Galactorrhoea Professional Mysoline (Primidone) C Hyperprolactinaemia Serevent (Salmeterol Tremor Xinafoate) C Theophylline (Theophylline) C Depakote (Valproate Semisodium) C Ativan (Lorazepam) C Albuterol (Salbutamol) C Date:02/21/01ISR Number: 3669013-1Report Type:Periodic Company Report #JRFUSA2000000341 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Risperdal (Tablet) Initial or Prolonged (Risperidone) PS Janssen Research Foundation ORAL ORAL Date:02/21/01ISR Number: 3669014-3Report Type:Periodic Company Report #JRFUSA2000000378 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Risperdal (1 Mg Initial or Prolonged Tablet) (Risperidone) PS Janssen Research Foundation ORAL 5 MG, 1 IN 1 DAY(S), ORAL Klonopin (Clonazepam) C Zoloft (Sertraline Hydrochloride) C Date:02/21/01ISR Number: 3669015-5Report Type:Periodic Company Report #JRFUSA2000000405 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Murmur Consumer Risperdal (Tablet) Initial or Prolonged Condition Aggravated (Risperidone) PS Janssen Foundation ORAL 3 MG.1 IN 1, Headache DAY(S), ORAL Sedation Date:02/21/01ISR Number: 3669647-4Report Type:Periodic Company Report #JRFUSA2000000540 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Health Risperdal ( 1 Mg. Professional Tablet) (Risperidone) PS Janssen Research Foundation ORAL 1 MG. 1 IN 1 DAY(S), ORAL Effexor (Venlafaxine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 977 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cytomel (Liothyronine Sodium) C Anfranil (Clomipramine Hydrochloride) C Neurontin (Gabapentin) C Date:02/21/01ISR Number: 3669648-6Report Type:Periodic Company Report #JRFUSA2000000711 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal ( 3 Initial or Prolonged Drug Abuser Tablet) Dyspepsia (Risperidone) PS Janssen Research Injury Foundation ORAL 6 MG. 5 IN 1 Sedation DAY(S), ORAL Therapeutic Response Thorazine Increased (Chlorpromazine Hydrochloride) C Benadryl (Diphenhydramine Hydrochloride) C Lithium (Lithium) C Antihypertensives (Antihypertensives) C Date:02/21/01ISR Number: 3669649-8Report Type:Periodic Company Report #JRFUSA2000000838 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Risperdal ( Tablet) Initial or Prolonged Coma Professional (Risperidone) PS Janssen Fdn ORAL 1 MG. 2 IN 1 Required Condition Aggravated DAY(S), ORAL Intervention to Sedation SEE IMAGE Prevent Permanent Impairment/Damage Date:02/21/01ISR Number: 3669650-4Report Type:Periodic Company Report #JRFUSA2000000844 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (3 Mg Initial or Prolonged Coordination Abnormal Tablet) Insomnia (Risperidone) PS Janssen Fds ORAL 3 MG. 2 IN Sedation 1 DAY(S), ORAL Depakote (Valproae Semisodium) C Ambien (Zolpidem Tartrate) C 22-Feb-2006 08:20 AM Page: 978 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3669651-6Report Type:Periodic Company Report #JRFUSA2000000951 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Effect Increased Consumer Risperdal (Tablet) Suicide Attempt (Risperidone) PS Janssen Research Fdn ORAL ORAL Date:02/21/01ISR Number: 3669652-8Report Type:Periodic Company Report #JRFUSA2000000995 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Health Risperdal Initial or Prolonged Professional (Unspecified) (Risperidone) PS Janssen Research Fds ORAL ORAL Glucotrol (Glipizide) SS ORAL ORAL Date:02/21/01ISR Number: 3669653-XReport Type:Periodic Company Report #JRFUSA2000001056 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Health Risperdal (2 Mg Initial or Prolonged Tachycardia Professional Tablet) Required (Tisperidone) PS Janssen Research Fdn ORAL 2 MG. 2 IN 1 Intervention to DAY(S), ORAL Prevent Permanent Impairment/Damage Date:02/21/01ISR Number: 3669654-1Report Type:Periodic Company Report #JRFUSA1999004203 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Depression Depakote (Valproate Mania Semisodium) C Date:02/21/01ISR Number: 3669655-3Report Type:Periodic Company Report #JRFUSA1999004358 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Confusional State Aricept (Donepezil Depression Hydrochloride) C Extrapyramidal Disorder Prozac (Fluoxetine Speech Disorder Hydrochloride) C Urinary Incontinence Cozaar (Losartan Potassium) C Mevacor (Lovastatin) C Date:02/21/01ISR Number: 3669656-5Report Type:Periodic Company Report #JRFUSA1999004363 Age:68 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:20 AM Page: 979 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Agitation Health Risperdal PS Janssen Research Fdn ORAL ORAL Confusional State Professional Olanzapine Extrapyramidal Disorder (Olanzapine) SS Bupropion (Amfebutamone) C Depakote (Valproate Semisodium) C Prednisone (Prednisone) C Date:02/21/01ISR Number: 3669659-0Report Type:Periodic Company Report #JRFUSA1999004368 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Sexual Dysfunction Depakote (Valproate Semisodium) C Prednisone (Predni- C Bupropion (Amfebutamone) C Date:02/21/01ISR Number: 3669661-9Report Type:Periodic Company Report #JRFUSA1999004393 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Date:02/21/01ISR Number: 3669663-2Report Type:Periodic Company Report #JRFUSA1999004409 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Weight Decreased Date:02/21/01ISR Number: 3669665-6Report Type:Periodic Company Report #JRFUSA1999004454 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen Research Fdn ORAL 4 MG, 2 IN Initial or Prolonged Suicide Attempt DAY(S), ORAL Seroquel (Seroquel) C Relafen (Nabumetone) C Neurontin(Gabapentin ) C Klonopin (Clonazepam) C 22-Feb-2006 08:20 AM Page: 980 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3669667-XReport Type:Periodic Company Report #JRFUSA1999004468 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Risperdal PS Janssen Research Fdn ORAL 2 MG, 2 IN 1 Initial or Prolonged Professional DAY(S), ORAL Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Date:02/21/01ISR Number: 3669669-3Report Type:Periodic Company Report #JRFUSA1999004501 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Risperdal PS Janssen Research Fdn ORAL 1 MG, 2 IN 1 Initial or Prolonged DAY(S), ORAL Thorazine (Chlorpromazine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Benadryl (Diphenhydramine Hydrochloride) C Date:02/21/01ISR Number: 3669671-1Report Type:Periodic Company Report #JRFUSA1999004531 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dry Mouth Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Injury Date:02/21/01ISR Number: 3669674-7Report Type:Periodic Company Report #JRFUSA2000000013 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Health Risperdal PS Janssen Research Fdn ORAL 2 MG, 1 IN Initial or Prolonged Extrapyramidal Disorder Professional 1 DAY(S), Gait Disturbance ORAL Hypertonia Paxil (Paroxetine Pyrexia Hydrochloride) C Salivary Hypersecretion Date:02/21/01ISR Number: 3669677-2Report Type:Periodic Company Report #JRFUSA2000000014 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen Research Fdn ORAL 1 MG. 1 IN 1 Initial or Prolonged DAY(S), ORAL Haldol SS ORAL ORAL Cogentin(Benzatropin e Mesilate) C Ativan(Lorazepam) C 22-Feb-2006 08:20 AM Page: 981 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3669679-6Report Type:Periodic Company Report #JRFUSA2000000029 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal PS Janssen Research Fdn ORAL 2.5 MG, 1 IN Initial or Prolonged Salivary Hypersecretion Professional 1 DAY(S), ORAL Depakote (Valproate Semisodium) C Synthroid (Levothyroxine Sodium) C Date:02/21/01ISR Number: 3669681-4Report Type:Periodic Company Report #JRFUSA2000000060 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthma Consumer Risperdal PS Janssen Research Fdn ORAL 1 MG. 2 IN 1 Initial or Prolonged Cough DAY(S), ORAL Albuterol(Salbutamol ) C Date:02/21/01ISR Number: 3669683-8Report Type:Periodic Company Report #JRFUSA2000000064 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Risperdal PS Janssen Research Fdn ORAL 2 MG 1 IN 2 Initial or Prolonged Neuroleptic Malignant Professional DAY(S), ORAL Required Syndrome Haldol Decanoate SS 100 MG, 1 IN Intervention to 1 MONTH(S) IM Prevent Permanent Haldol SS ORAL Impairment/Damage Klonopin (Clonazepam) C Depakote (Valproate Semisodium) C Date:02/21/01ISR Number: 3669685-1Report Type:Periodic Company Report #JRFUSA2000000095 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Risperdal PS Janssen Research Fdn ORAL 3 MG. 2 IN 1 Initial or Prolonged Cardiac Arrest DAY(S), ORAL Required Chest Pain Haloperidol SS ORAL 2 MG, 4 IN 1 Intervention to Extrapyramidal Disorder DAY(S), ORAL Prevent Permanent Feeling Of Body Avitan(Lorazepam) C Impairment/Damage Temperature Change Olanzapine Headache (Olanzapine) C Sensory Disturbance Tachycardia Date:02/21/01ISR Number: 3669691-7Report Type:Periodic Company Report #JRFUSA2000000146 Age:24 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged 22-Feb-2006 08:20 AM Page: 982 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3669693-0Report Type:Periodic Company Report #JRFUSA2000000154 Age:24 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Consumer Risperdal PS Janssen Research Fdn ORAL 3 MG. 2 IN 1 Initial or Prolonged DAY(S), ORAL Paxil(Paroxetine Hydrochloride) C Trazodone (Trazodone) C Date:02/21/01ISR Number: 3669706-6Report Type:Periodic Company Report #JRFUSA2000000203 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Consumer Risperdal PS Janssen Research Fdn OPHTHALMIC 2 MG. 1 IN 1 Initial or Prolonged Deficit/Hyperactivity DAY(S), ORAL Disorder Depakote SS ORAL 1250 MG. Condition Aggravated DAILY, ORAL Libido Decreased Glucophage(Metformin Tremor Hydrochloride) C Micronase(Glibenclam ide) C Date:02/21/01ISR Number: 3669707-8Report Type:Periodic Company Report #JRFUSA000000232 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Syndrome Professional Date:02/21/01ISR Number: 3673800-3Report Type:Periodic Company Report #JRFUSA1999000326 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Risperdal PS Janssen Research Fdn ORAL 1 MG, 2 IN 1 Initial or Prolonged Constipation DAY(S), ORAL Depression Prozac(Fluoxetine Dizziness Hydrochloride) SS ORAL 1 TIME(S), Drug Effect Decreased ORAL Flushing Thorazine C Suicide Attempt Zoloft(Sertraline Hydrochloride) C Date:02/21/01ISR Number: 3673804-0Report Type:Periodic Company Report #JRFUSA1999000568 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Literature Risperdal PS Janssen Research Fdn ORAL 2 MG, 2 IN 1 Hospitalization - Ketoacidosis Health DAY(S), ORAL Initial or Prolonged Professional Prozac(Fluoexetine Disability Company Hydrochloride) C Required Representative Trazodone C Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:20 AM Page: 983 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3673806-4Report Type:Periodic Company Report #JRFUSA1999001216 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Dizziness Haldol SS ORAL ORAL Malaise Date:02/21/01ISR Number: 3673807-6Report Type:Periodic Company Report #JRFUSA1999001645 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Risperdal PS Janssen Research Fdn ORAL 3 MG, 2 IN 1 Initial or Prolonged Anxiety DAY(S), ORAL Arteriosclerosis Artane(Trihexyphenid Depression yl Hydrochloride) SS ORAL 2 MG, 3 IN 1 Dizziness DAY (S), ORAL Injury Stelazine C Suicide Attempt Lithium C Tardive Dyskinesia Nolvadex (Tamoxifen) C Date:02/21/01ISR Number: 3673809-XReport Type:Periodic Company Report #JRFUSA1999002697 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Consumer Risperdal PS Janssen Research Fdn ORAL 9 MG, DAILY, Initial or Prolonged Health ORAL Required Professional Zyprexa (Olanzapine) C Intervention to Thiothixene(Tiotixen Prevent Permanent e) C Impairment/Damage Cogentin (Benzatropine Besilate) C Date:02/21/01ISR Number: 3673818-0Report Type:Periodic Company Report #JRFUSA1999002986 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Consumer Risperdal PS Janssen Research Fdn ORAL 2 MG, 1 IN 1 Initial or Prolonged Condition Aggravated DAY(S), ORAL Depression Prescription C Drug Effect Decreased Remeron(Mirtazapine) C Injury Ambien C Sedation Robaxin C Suicide Attempt Prozac C Klonopin C Date:02/21/01ISR Number: 3673820-9Report Type:Periodic Company Report #JRFUSA1999003521 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Risperdal PS Janssen Research Fdn ORAL 1 MG, 2 IN 1 Initial or Prolonged Paranoia DAY(S), ORAL Prozac(Fluoexetine Hydrochloride) C Neurontin(Gabapentin ) C Wellbutrin(Amfebutam 22-Feb-2006 08:20 AM Page: 984 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report one Hydrochloride) C Date:02/21/01ISR Number: 3673822-2Report Type:Periodic Company Report #JRFUSA1999003652 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Nausea Health Risperdal PS Janssen Research Fdn ORAL 2 MG, 2 IN 1 Hospitalization - Neuroleptic Malignant Professional DAY(S) ORAL Initial or Prolonged Syndrome Paxil(Paroxetine Required Hydrochloride) SS ORAL 20 MG, 1 IN 1 Intervention to DAY(S), ORAL Prevent Permanent Impairment/Damage Date:02/21/01ISR Number: 3673827-1Report Type:Periodic Company Report #JRFUSA1999003653 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Gait Disturbance Health Risperdal PS Janssen Research Fdn ORAL 4 MG, 1 IN 1 Hospitalization - Hyponatraemia Professional DAY(S) ORAL Initial or Prolonged Neuroleptic Malignant Required Syndrome Intervention to Prevent Permanent Impairment/Damage Date:02/21/01ISR Number: 3673830-1Report Type:Periodic Company Report #JRFUSA2000004461 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Risperdal PS Janssen Research Fdn ORAL 1 MG, 1 IN 1 Initial or Prolonged Orthostatic Hypotension Professional DAY, ORAL Required Sedation Zoloft(Sertraline Intervention to Speech Disorder Hydrochloride) SS ORAL 25 MG, 1 IN 1 Prevent Permanent DAY(S), ORAL Impairment/Damage Haldol(Injection) C Aricept(Donepezil Hydrochloride) C Prozac(Fluoxetine Hydrochloride) C Hydrodiuril C Levaquin(Levofloxaci n) C Ativan(Lorazepam) C Multiple Vitamins C Mellaril(Thioridazin e Hydrochloride) C Vitamin E (Tocopherol) C Diovan (Valsartan) C Timoptic (Timolol Maleate) C Ecotrin (Acetylsalicylic Acid) C 22-Feb-2006 08:20 AM Page: 985 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/01ISR Number: 3675530-0Report Type:Periodic Company Report #JRFUSA2000005322 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Date:02/21/01ISR Number: 3675540-3Report Type:Periodic Company Report #JRFUSA2000006104 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heat Stroke Health Risperdal PS Janssen Research Fdn ORAL 5.5 MG, 1 Initial or Prolonged Professional DAILY, ORAL Valproic Acid (Valproic Acid) C Clonazepam (Clonazepam) C Benztropine (Bentropine) C Diphenhydramine (Diphenhydramine) C Vitamin E (Tocopherol) C Vitamin C (Ascoribic Acid) C Date:02/21/01ISR Number: 3675544-0Report Type:Periodic Company Report #JRFUSA2000004785 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal PS Janssen Research Pituitary Tumour Benign Professional Foundation ORAL DAILY, ORAL Company Zoloft (Setraline Representative Hydrochloride) C Date:02/21/01ISR Number: 3675546-4Report Type:Periodic Company Report #JRFUSA2000008707 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Consumer Risperdal PS Janssen Research Fdn ORAL 1 MG, 1 IN 1 DAY (S), ORAL Date:02/22/01ISR Number: 3668429-7Report Type:Direct Company Report # Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Delirium Risperidone 2mg Hospitalization - Haemolysis Janssen PS Janssen ORAL 2MG BID ORAL Initial or Prolonged Medication Error Required Mental Disorder Intervention to Nervous System Disorder Prevent Permanent Thrombotic Impairment/Damage Thrombocytopenic Purpura 22-Feb-2006 08:20 AM Page: 986 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/01ISR Number: 3669766-2Report Type:Expedited (15-DaCompany Report #NSADSS2001003698 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Delirium Professional Lithium (Lithium) SS ORAL ORAL Required Diabetes Insipidus Intervention to Platelet Count Decreased Prevent Permanent Thrombotic Impairment/Damage Thrombocytopenic Purpura Date:02/23/01ISR Number: 3669767-4Report Type:Expedited (15-DaCompany Report #NSADSS2001003705 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Consumer Risperdal PS Janssen Research Fdn ORAL 4 MG, DAILY, Initial or Prolonged Constipation ORAL Pneumonia Date:02/23/01ISR Number: 3670196-8Report Type:Expedited (15-DaCompany Report #EMADSS2001000694 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Foreign Risperdal PS Janssen Research Fdn DOSAGE NOT Health THERAPY NOT Professional Tercian C Date:02/23/01ISR Number: 3670198-1Report Type:Expedited (15-DaCompany Report #EMADSS2001000719 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG, 1 IN 1 Health DAILY, ORAL Professional Date:02/23/01ISR Number: 3670201-9Report Type:Expedited (15-DaCompany Report #EMADSS2001000693 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Toxic Epidermal Health Dehydrobenzperidol Necrolysis Professional (Droperidol) SS Date:02/23/01ISR Number: 3670205-6Report Type:Expedited (15-DaCompany Report #EMADSS2001000710 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Risperdal PS Janssen Research Fdn DOSE AND Hospitalization - Medication Error Health THERAPY DATES Initial or Prolonged Psychotic Disorder Professional NOT KNOWN Sudden Death 22-Feb-2006 08:20 AM Page: 987 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/01ISR Number: 3670208-1Report Type:Expedited (15-DaCompany Report #NSADSS20010003731 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Hospitalization - Cardiac Arrest Health Haloperidol SS INTRAMUSCULAR 10 MG, 1 IN 8 Initial or Prolonged Professional HOUR(S), IM Diacepam SS INTRAMUSCULAR 20 MG, 1 IN 8 HOUR(S), IM Levopromacine SS INTRAMUSCULAR 25 MG, 1 IN 8 HOUR(S), IM Date:02/23/01ISR Number: 3670210-XReport Type:Expedited (15-DaCompany Report #EMADSS2001000688 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypersensitivity Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG, 2 IN 1 Health DAILY, ORAL Professional Lisinopril C Zopiclone C Spironolactone C Cabamazepine C Warfarin C Allopurinol C Digoxin C Date:02/26/01ISR Number: 3670694-7Report Type:Expedited (15-DaCompany Report #EMADSS2001000693 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Toxic Epidermal Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Necrolysis Health Professional Date:02/26/01ISR Number: 3671139-3Report Type:Expedited (15-DaCompany Report #EMADSS2001000437 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL 3 MG, DAILY, Health ORAL Professional Plenur (Lithium Carbonate) C Date:02/27/01ISR Number: 3670689-3Report Type:Expedited (15-DaCompany Report #EMADSS2001000738 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Aspiration Foreign Risperdal PS Janssen Research Fdn OPHTHALMIC 2 MG, 2 IN 1 Initial or Prolonged Health DAILY, ORAL Professional Tiapridal (Tiapride) SS Sectral (Acebutol Hydrochloride) C Fenofibrate (Fenofibrate) C Exelon (Rivastigmine) C 22-Feb-2006 08:20 AM Page: 988 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/01ISR Number: 3671220-9Report Type:Expedited (15-DaCompany Report #EMADSS2001000708 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG, DAILY, Health ORAL Professional Moldidomin (Molsidomine) C Furosemid (Furosemide) C Fosinopril (Fosinopril) C Prednisolone (Prednisolone) C Date:02/27/01ISR Number: 3671221-0Report Type:Expedited (15-DaCompany Report #EMADSS2001000730 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL 5 MG, 1 IN 1 Health DAILY, ORAL Professional Tavor (Lorazepam) C Date:02/27/01ISR Number: 3671222-2Report Type:Expedited (15-DaCompany Report #EMADSS2001000735 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn 2-8 MG DAILY Health Timonil Professional (Carbamazepine) SS 450-750 MG DAILY Tavor (Lorazepam) C Hepa-Loges N (Fructus Cardui Mariae) C Date:02/27/01ISR Number: 3671289-1Report Type:Direct Company Report # Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Prolixin Decanoate Initial or Prolonged Loss Of Consciousness 50 Mg (High Neuroleptic Malignant Probability) PS INTRAMUSCULAR 50 MG IM Syndrome Risperdal 3 Mg Qd Pyrexia (Low Probability) SS 3 MG QD Tachycardia Tachypnoea Tremor Date:02/28/01ISR Number: 3671053-3Report Type:Direct Company Report # Age:32 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:20 AM Page: 989 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Risperdal 2 Mg Po Dysarthria Bid PS ORAL 2 MG BID PO Extrapyramidal Disorder Zyprexa 10 Mg X 1 Hallucination, Visual Dose SS ORAL 10 MG MS PO Heart Rate Increased Trazodone 100 Mg Hs SS 100 MG HS Pyrexia Haldol 5 Mg 1m X 1 SS INTRAMUSCULAR 5 MG IM X 1 Restlessness Effexor 75 Mg Xr Po Speech Disorder Qd SS ORAL 75 MG XR PO QD Benztropine 2 Mg Po Bid SS ORAL 2 MG PO BID Cogentin C Effexor C Wellbutrin C Gabapentin C Paxil C Compazine C Meclizine C Trazodone C Acyclovir C Thiamine C Mvi C Unasyin C Date:02/28/01ISR Number: 3671628-1Report Type:Direct Company Report # Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Body Temperature Risperidal PS 8MG Q D / Hospitalization - Increased APPROX. 4-6 Initial or Prolonged Dysuria WEEKS 4 WK Required Fall Clozapine SS 450 QHS Intervention to Hyperhidrosis Prevent Permanent Pyrexia Impairment/Damage Tachycardia Tachypnoea Date:02/28/01ISR Number: 3671857-7Report Type:Periodic Company Report #001-0945-M0001176 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Neurontin PS Parke Davis Initial or Prolonged Uterine Haemorrhage Professional Pharmaceuticals Ltd ORAL 600 MG (300 MG BID) PER ORAL Depo-Provera (Medroxyprogesterone Acetate) SS Risperdal (Risperidone) SS ORAL 4 MG (2 MG, BID) PER ORAL Serzone (Nefazodone Hydrochloride) C (Trazodone) C 22-Feb-2006 08:20 AM Page: 990 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3672647-1Report Type:Periodic Company Report #A038759 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Zoloft PS Pfizer Headache Professional Pharmaceuticals Inc Company Risperidone SS Representative Date:02/28/01ISR Number: 3672705-1Report Type:Periodic Company Report #A037625 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Other Zoloft PS Pfizer Initial or Prolonged Neuroleptic Malignant Pharmaceuticals Inc Required Syndrome Risperidone SS ORAL 6.00 MG Intervention to TOTAL:BID:ORA Prevent Permanent L Impairment/Damage Date:02/28/01ISR Number: 3676183-8Report Type:Periodic Company Report #9934713 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Zoloft PS Pfizer Drug Ineffective Pharmaceuticals Inc ORAL 50.00 MG Haematuria TOTAL:DAILY:O Insomnia RAL Sedation Zyprexa SS Weight Increased Risperdal SS ORAL 1.00 MG TOTAL:DAILY:O RAL Vitamins C Date:02/28/01ISR Number: 3677685-0Report Type:Periodic Company Report #A037783 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Zoloft PS Pfizer Initial or Prolonged Attention Pharmaceuticals Inc ORAL ORAL Deficit/Hyperactivity Risperdal SS ORAL ORAL Disorder Mirtazapine SS ORAL ORAL Emotional Disorder Warfarin C Hallucination Benazepril C Psychotic Disorder Conjugated Estrogens C Sedation Cyanocobalamin C Thinking Abnormal Digoxin C Diltiazem C Macrogol C Psyllium Hydrophillic Mucilloid C Inhaler-Type Unknown C Unknown Tablet C 22-Feb-2006 08:20 AM Page: 991 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/01ISR Number: 3678017-4Report Type:Periodic Company Report #A020879 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Caffeine Increased Other Zoloft PS Pfizer Completed Suicide Pharmaceuticals Inc Injury Asphyxiation Haloperidol SS Risperdal SS Other Medication (Unspecified) SS Vicks Vaporub C Nicobid C Meclizine C Date:02/28/01ISR Number: 3679251-XReport Type:Periodic Company Report #A030376 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Zoloft PS Pfizer Drug Ineffective Pharmaceuticals Inc 200.00 MG Intentional Overdose TOTAL:DAILY Risperdal SS Xanax C Evista C Date:02/28/01ISR Number: 3679796-2Report Type:Periodic Company Report #A007919 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Zoloft PS Pfizer Arrhythmia Pharmaceuticals Inc 150.00 MG Asthenia TOTAL DAILY Chest Pain Riperdal SS DAILY Drug Ineffective Eye Pain Headache Hypertonia Muscle Twitching Neurosis Oedema Oedema Peripheral Orthostatic Hypotension Pain Paraesthesia Skin Discolouration Tremor Weight Increased Date:02/28/01ISR Number: 3679840-2Report Type:Periodic Company Report #A036781 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pruritus Health Zoloft PS Pfizer Urticaria Professional Pharmaceuticals Inc ORAL 10.00 MG TOTAL;DAILY;O RAL Risperdal SS ORAL 0.25 MG TOTAL;DAILY;O RAL 22-Feb-2006 08:20 AM Page: 992 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/01ISR Number: 3672132-7Report Type:Expedited (15-DaCompany Report #2001045788US Age:69 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Covera-Hs PS Gd Searle And Co ORAL ORAL Professional Metoprolol(Metoprolo l) SS ORAL ORAL Risperidone(Risperid one) SS ORAL ORAL Date:03/01/01ISR Number: 3672182-0Report Type:Expedited (15-DaCompany Report #2001045716US Age:72 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Calan PS Gd Searle And Co ORAL ORAL Professional Clonazepam (Clonazepam) SS ORAL ORAL Risperidone (Risperidone) SS ORAL ORAL Date:03/01/01ISR Number: 3672312-0Report Type:Expedited (15-DaCompany Report #EMADSS2001000695 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal PS Janssen Research Fdn 0.25 MG, Health DAILY; 0.75 Professional MG, DAILY Date:03/01/01ISR Number: 3672313-2Report Type:Expedited (15-DaCompany Report #EMADSS2001000697 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Risperdal PS Janssen Research Fdn DAILY, Health UNKNOWN; 2.5 Professional DAILY Enalapril (Enalapril) C Torem (Torsemide) C Isosorbide Dinitrate (Isosorbide Dinitrate) C Beloc Zok (Metoprolol Succinate) C Sigaperidol (Haloperidol) C Date:03/02/01ISR Number: 3672992-XReport Type:Expedited (15-DaCompany Report #EMADSS2001000838 Age:56 YR Gender:Male I/FU:I Outcome PT Other Abscess Aplastic Anaemia Bone Marrow Depression Carbuncle Diabetes Mellitus Diarrhoea Dyspnoea 22-Feb-2006 08:20 AM Page: 993 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eyelid Oedema Muscle Spasms Restlessness Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal PS Janssen Research Fdn ORAL ORAL Health Mallorol Professional (Thioridazine Hydrochloride) SS ORAL 25 MG, ORAL Panodil (Paracetamol) C Inderal (Propranolol Hydrochloride) C Litiumkarbonat (Lithium Carbonate) C Acetylcystein C Imodium (Unspecified) (Loperamide Hydrochloride) C Date:03/02/01ISR Number: 3672994-3Report Type:Expedited (15-DaCompany Report #EMADSS2001000702 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal PS Janssen Research Fdn 1.5 MG, 1 IN Fall Health 1 DAILY Professional Depakine (Valproate Sodium) C Phenobarbital C Date:03/05/01ISR Number: 3673934-3Report Type:Expedited (15-DaCompany Report #EMADSS2001000862 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal PS Janssen Research Fdn ORAL 6 MG, DAILY, Drug Ineffective Health ORAL Neutrophil Count Professional Leponex (Clozapine) SS ORAL 100 MG, Decreased DAILY, ORAL Psychotic Disorder Zyprexa (Olanzapine) SS ORAL 10 MG, DAILY, White Blood Cell Count ORAL Decreased Disipal (Orphenadrine Hydrochloride) C Propavan (Propiomazine Maleate) C Zolfot (Sertraline Hydrochloride) C Date:03/05/01ISR Number: 3673936-7Report Type:Expedited (15-DaCompany Report #EMADSS2001000873 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gamma-Glutamyltransferase Foreign Risperdal PS Janssen Research Fdn ORAL 3 MG, DAILY, Increased Health ORAL Red Blood Cell Count Professional Decreased 22-Feb-2006 08:20 AM Page: 994 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/01ISR Number: 3673939-2Report Type:Expedited (15-DaCompany Report #JAKYO33837 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG, DAILY, Health ORAL Professional Haldol (Tablet) (Haloperidol) C Levomepromazine (Levomepromazine) C Flunitrazepam (Tablet) (Flunitrazepam) C Voglibose (Tablet) (Voglibose) C Bezafibrate (Tablet) (Bezafibrate) C Insulin (Insulin) C Etizolam (Etizolam) C Date:03/05/01ISR Number: 3673941-0Report Type:Expedited (15-DaCompany Report #NSADSS2001004413 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal PS Janssen Research Fdn ORAL ORAL Health Professional Company Representative Date:03/05/01ISR Number: 3674202-6Report Type:Expedited (15-DaCompany Report #JRFBEL2000002189 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspartate Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG, DAILY, Hospitalization - Aminotransferase Health ORAL Initial or Prolonged Increased Professional Luvox (Fluvoxamine) C Disability Paralysis Prochlorperazine Required Renal Impairment (Prochlorperazine Intervention to Rhabdomyolysis Maleate) C Prevent Permanent Thirst Biperiden Impairment/Damage Hydrochloride C Date:03/05/01ISR Number: 3674204-XReport Type:Expedited (15-DaCompany Report #NSADSS2001004721 Age:5 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Henoch-Schonlein Purpura Health Ritalin Professional (Methylphenidate Hydrochloride) C Date:03/05/01ISR Number: 3674206-3Report Type:Expedited (15-DaCompany Report #EMADSS2001000766 Age:70 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:20 AM Page: 995 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Pyrexia Foreign Risperdal PS Janssen Research Fdn Toxic Epidermal Health Imovane (Zopiclone) C Necrolysis Professional Xanax (Alprazolam) C Company Aldalix Representative (Osyrol-Lasix) C Date:03/05/01ISR Number: 3674605-XReport Type:Expedited (15-DaCompany Report #NSADSS2001003731 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Foreign Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Hospitalization - Cardiac Arrest Health Haloperidol Initial or Prolonged Professional (Haloperidol) SS INTRAMUSCULAR 10 MG, 1 IN 8 HOUR(S), IM Diacepam SS INTRAMUSCULAR 20 MG, 1 IN 8 HOUR(S), IM Levopromacine SS INTRAMUSCULAR 25 MG, 1 IN 8 HOUR(S), IM .. SS .. SS Date:03/06/01ISR Number: 3674958-2Report Type:Expedited (15-DaCompany Report #01P-163-0103666-00 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutrophil Count Health Depakote PS Abbott Laboratories ORAL PER ORAL Intervention to Decreased Professional Risperidone Prevent Permanent (Risperidone) SS ORAL 2 MG, 1 IN 1 Impairment/Damage D, PER ORAL Clozapine (Clozapine) SS ORAL PER ORAL Date:03/09/01ISR Number: 3676794-XReport Type:Expedited (15-DaCompany Report #255822 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Sodium Increased Bactrim Ds Tablets PS Roche Life-Threatening Encephalopathy Risperdal SS 1 MG AT 09.00 Hospitalization - Malnutrition AM AND 0.5 MG Initial or Prolonged Neuroleptic Malignant AT 2 PM. Syndrome START DATE Pneumonia REPORTED AS Renal Failure Symmetrel SS Respiratory Failure Norvasc C Shock Prilosec C Urinary Incontinence Eldepryl C Fosamax C Date:03/09/01ISR Number: 3677629-1Report Type:Direct Company Report # Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Risperdal 2mg, 3mg PS ORAL (PO) 2MG AM, 3MG HS 22-Feb-2006 08:20 AM Page: 996 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium Carbonate C Date:03/09/01ISR Number: 3678114-3Report Type:Expedited (15-DaCompany Report #EMADSS2001000865 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dermatitis Foreign Duragesic PS Alza Corp TRANSDERMAL 25 MCG TRANSD Dyspnoea Health Risperdal Gastrooesophageal Reflux Professional (Risperidone) SS ORAL 1.5 MG DAILY Disease ORAL Lip Ulceration Heminevrin Mouth Ulceration (Clomethiazole Oral Intake Reduced Edisilate) SS UNKNOWN 300 MG DAILY Pruritus Propavan Toxic Epidermal (Propiomazine Necrolysis Maleate) SS ORAL 25 MG DAILY ORAL Mycostatin (Nystatin) SS UNKNOWN 4 ML DAILY Plavix (Clopidogrel Sulfate) SS ORAL 75 MG DAILY ORAL Imovane (Zopiclone) C Erco-Fer (Ferrous Fumarate) C Theo (Theophylline) C Spironolakton (Spironolactone) C Date:03/09/01ISR Number: 3678122-2Report Type:Expedited (15-DaCompany Report #EMADSS2001000865 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrooesophageal Reflux Foreign Risperdal PS Janssen Research Fdn ORAL 1.5 MG, Disease Health DAILY, ORAL Oral Intake Reduced Professional Durogesic (Patch) Oral Mucosal Exfoliation (Fentanyl) SS TRANSDERMAL 25 MCG, Rash Pruritic TRANSD Respiratory Disorder Heminevrin Toxic Epidermal (Clomethiazole Necrolysis Edisilate) SS 300 MG, DAILY, Propavan (Propiomazine Maleate) SS ORAL 25 MG, DAILY, ORAL Mycostatin (Nystatin) SS 4 ML, DAILY, Plavix (Clopidogrel Sulfate) SS ORAL 75 MG, DAILY, ORAL Imovane (Zopiclone) C Erco-Fer (Ferrous Fumarate) C Theo (Theophylline) C Spironolakton (Spironolactone) C 22-Feb-2006 08:20 AM Page: 997 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/09/01ISR Number: 3678127-1Report Type:Expedited (15-DaCompany Report #EMADSS2001000997 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Hypotension Health Tercian Professional (Cyamemazine) SS ORAL ORAL Lexomil (Bromazepam) C Noctamide (Lormetazepam) C Bromazepam (Bromazepam) C Lormetazepam (Lormetazepam) C Date:03/09/01ISR Number: 3678132-5Report Type:Expedited (15-DaCompany Report #EMADSS2001000885 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn DOSE BETWEEN Health 2 AND 4MG PER Professional DAY Date:03/09/01ISR Number: 3678140-4Report Type:Expedited (15-DaCompany Report #EMADSS2001000895 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal PS Janssen Research Fdn 0.5 MG, 3 IN Health 1 DAY(S), Professional Stilnox (Zolpidem) C Date:03/09/01ISR Number: 3678174-XReport Type:Expedited (15-DaCompany Report #EMADSS2001000738 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchial Obstruction Foreign Risperdal PS Janssen Research Fdn ORAL 4 MG, 2 IN 1 Initial or Prolonged Pneumonia Aspiration Health DAILY, ORAL Rales Professional Tiapridal (Tiapride) SS Respiratory Distress Exelon (Rivastigmine) C Zestril (Lisinopril) C Esidrex (Hydrochlorothiazide ) C Date:03/09/01ISR Number: 3678245-8Report Type:Expedited (15-DaCompany Report #NSADSS2001004888 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Health Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Schizophrenia Professional 22-Feb-2006 08:20 AM Page: 998 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/01ISR Number: 3680317-9Report Type:Expedited (15-DaCompany Report #S01-USA-00393-01 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorectal Disorder Health Celexa PS Forest Laboratories Initial or Prolonged Colitis Professional Inc ORAL 40 MG QD PO Colitis Ulcerative Celexa (Citalopram Diarrhoea Haemorrhagic Hydrobromide) SS ORAL 30 MG QD PO Haematocrit Decreased Neurontin Haemoglobin Decreased (Gabapentin) SS Rectal Haemorrhage Risperdal Sinusitis (Risperidone) SS Date:03/12/01ISR Number: 3680513-0Report Type:Expedited (15-DaCompany Report #255822 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Consumer Bactrim Ds PS Hoffmann La Roche Life-Threatening Fluctuation Inc ORAL 2 PER DAY Hospitalization - Blood Sodium Increased ORAL Initial or Prolonged Dehydration Risperdal Dystonia (Risperidone) SS ORAL 1.5 MG DAILY Encephalopathy 2 PER DAY Leukocytosis ORAL Malnutrition Symmetrel Mental Disorder (Amantadine Multi-Organ Failure Hydrochloride) SS ORAL 100 MG 2 PER Muscle Rigidity DAY ORAL Neuroleptic Malignant Norvasc (Amlodipine Syndrome Besylate) C Pneumonia Prilosec Pyrexia (Omeprazole) C Respiratory Rate Eldepryl (Selegiline Increased Hydrochloride) C Tachycardia Fosamax (Alendronate Tremor Sodium) C Urinary Incontinence Weight Decreased Date:03/12/01ISR Number: 3680518-XReport Type:Expedited (15-DaCompany Report #2000UW01591 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cataract Health Seroquel PS Astrazeneca Uk Ltd ORAL 250 MG HS PO 10 WK Intervention to Visual Acuity Reduced Professional Zyprexa SS Prevent Permanent Risperdal SS Impairment/Damage Date:03/12/01ISR Number: 3680548-8Report Type:Expedited (15-DaCompany Report #EMADSS2001001000 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperprolactinaemia Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG, 2 IN 1 Leukopenia Health DAY(S), ORAL Professional 22-Feb-2006 08:20 AM Page: 999 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/01ISR Number: 3680552-XReport Type:Expedited (15-DaCompany Report #EMADSS2001001027 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Shock Foreign Risperdal PS Janssen Research Fdn ORAL 0.5 MG, 1 IN Health 1 DAILY, ORAL Professional Haldol (Unspecified) (Haloperidol) C Metformin (Metformin) C Glibenclamid (Glibenclamide) C Nacom Retard (Sinemet) C Nacom (Sinemet) C Date:03/13/01ISR Number: 3679854-2Report Type:Direct Company Report # Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Quetiapine PS ORAL NOT A Initial or Prolonged Diabetes Mellitus RELIABLE PT Other Diabetic Ketoacidosis PO Disorientation Valproic Acid SS Thrombocytopenia Risperidone SS Haldol SS Benztropine SS Date:03/14/01ISR Number: 3680741-4Report Type:Direct Company Report # Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Enuresis Risperidone 1mg Initial or Prolonged Gynaecomastia Tablet PS ORAL 1 MG BID ORAL Other Quetiapine C Date:03/16/01ISR Number: 3683163-5Report Type:Expedited (15-DaCompany Report #NSADSS2001005556 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Consumer Risperdal PS Janssen Research Fdn ORAL 3 MG, 2 IN 1 Initial or Prolonged Condition Aggravated DAY(S), ORAL Emphysema Theophylline Insomnia (Theophylline) C Nasopharyngitis Nicotine Patch (Nicotine) C Albuterol (Salbutamol) C Atrovent (Ipratropium Bromide) C Flovent (Fluticasone Propionate) C 22-Feb-2006 08:20 AM Page: 1000 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/01ISR Number: 3683466-4Report Type:Expedited (15-DaCompany Report #EMADSS2001001145 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal PS Janssen Research Fdn ORAL 0.5 MG, Drug Ineffective Health DAILY, ORAL Professional Melperone C Furosemide C Tromcardin C Sotahexal C Date:03/16/01ISR Number: 3683468-8Report Type:Expedited (15-DaCompany Report #EMADSS2001001307 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Foreign Risperdal PS Janssen Research Fdn 3 MG, DAILY Hospitalization - Cystitis Health Trazolan Retard C Initial or Prolonged Pyrexia Professional Quitaxon C Stupor Dominal C Thrombotic Tranxene C Thrombocytopenic Purpura Ditropan C Logastric C Zyrtec C Date:03/16/01ISR Number: 3683470-6Report Type:Expedited (15-DaCompany Report #EMADSS2001001171 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal PS Janssen Research Fdn PATIENT WAS Health TAKING THIS Professional MEDICATION INTERMITTENTL Y PRIOR TO Tercian C Date:03/16/01ISR Number: 3683474-3Report Type:Expedited (15-DaCompany Report #EMADSS2001001241 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hydrocele Foreign Risperdal PS Janssen Research Fdn 0.5 - 1.5 MG Health DAILY Professional Glucobay C Acetylsalicylate C Isosorbide Mononitrate C Nifedipine C Date:03/16/01ISR Number: 3683475-5Report Type:Expedited (15-DaCompany Report #NSADSS2001005434 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal PS Janssen Research Fdn ORAL ORAL Health Professional 22-Feb-2006 08:20 AM Page: 1001 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/01ISR Number: 3683480-9Report Type:Expedited (15-DaCompany Report #NSADSS2001005494 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal PS Janssen Research Fdn ORAL 3 MG, 1 IN 1 Health DAY, ORAL Professional Date:03/16/01ISR Number: 3683482-2Report Type:Expedited (15-DaCompany Report #EMADSS2001000766 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blister Foreign Risperdal PS Janssen Research Fdn 1MG Hospitalization - Erythema Health PROGRESSIVELY Initial or Prolonged Pyrexia Professional INCREASED TO Toxic Epidermal Company 4MG Necrolysis Representative Imovane C Toxic Skin Eruption Xanax C Ixel C Date:03/16/01ISR Number: 3683717-6Report Type:Expedited (15-DaCompany Report #JRFUSA2000000409 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Foetal Distress Syndrome Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Date:03/19/01ISR Number: 3682881-2Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Klonopin (2 Mg Tid) PS Initial or Prolonged Risperdol (4mg Hs) SS Luvox 100 Mg Bid SS Zyprexa Po 200 SS Date:03/19/01ISR Number: 3684647-6Report Type:Expedited (15-DaCompany Report #EMADSS2001001410 Age:60 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Red Blood Cell Count Foreign Risperdal PS Janssen Research Fdn ORAL ORAL Decreased Health Professional Date:03/19/01ISR Number: 3684648-8Report Type:Expedited (15-DaCompany Report #JAKYO29715 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG DAILY Life-Threatening Coma Health ORAL ; 4 MG Required Depressed Level Of Professional DAILY ORAL Intervention to Consciousness Diazepam (Diazepam) C Prevent Permanent Hallucination, Auditory Promethazine Impairment/Damage Nasopharyngitis (Promethazine) C Respiratory Failure Perazine Fendizoate Shock (Perazine) C Tachycardia Trihexyphenidyl 22-Feb-2006 08:20 AM Page: 1002 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride (Trihexyphenidyl Hydochloride) C Stomachics And Digestive (Unspecified) C Brotizolam (Brotizolam) C Alprazolam (Alprazolam) C Nifedipine (Nifedipine) C Fluphenazine Enantate (Fluphenazine Enantate) C Serrapeptase (Serrapeptase) C Methylcysteine Hydrochloride (Unspecified) C Pelex (Pelex) C Chlorpheniramine Maleate (Chlorphenamine Maleate) C Tosufloxacin Tosilate (Tosufloxacin Tosilate) C Date:03/20/01ISR Number: 3685076-1Report Type:Direct Company Report # Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Bupropion PS Initial or Prolonged Medication Error Risperidone SS Clonazepam SS Venlafaxine SS Date:03/20/01ISR Number: 3685666-6Report Type:Direct Company Report # Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Risperdal / 0.5mg / Intervention to Corrected Interval Janssen PS Janssen ORAL 2.5MG QHS Prevent Permanent Prolonged ORAL Impairment/Damage Risperdal 2 Mg Janssen SS Janssen ORAL 0.5MG QAM ORAL Protonix C Celexa C Date:03/22/01ISR Number: 3687356-2Report Type:Expedited (15-DaCompany Report #256624 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Rivotril PS Roche Initial or Prolonged Clopixol - Slow 22-Feb-2006 08:20 AM Page: 1003 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Release SS Risperdal SS 7 DAY Depakine Chrono SS Date:03/22/01ISR Number: 3687916-9Report Type:Expedited (15-DaCompany Report #NSADSS2001005844 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Risperdal PS Janssen Research Fdn Therapeutic Professional Topamax (Tablet) (Topiramate) SS ORAL ORAL Zyprexa (Olanzapine) C Valproic Acid (Valproix Acid) C Date:03/22/01ISR Number: 3687925-XReport Type:Expedited (15-DaCompany Report #M0767-2000 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Remeron PS Organon Inc Sub Initial or Prolonged Psychotic Disorder Other Akzona Inc Risperidone SS 1-3 NG/DAY Sertraline Hcl (Zoloft) SS UNKNOWN Benazepri Hcl 20 Mg/Day C Cyanocobalamin C Digoxin C Diltiazem Hcl C Estrogens Conjugated 0.625 Mg.Day C Inhalant Unspecified (Acrosol) C Macrogol C Psyllium Hydrophilic Mucilloid Tablet C Warfarin Sodium 2-5 Mg/Day C Date:03/22/01ISR Number: 3687983-2Report Type:Expedited (15-DaCompany Report #EMADSS2001001357 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Tachycardia Foreign Risperdal PS Janssen Research Fdn TAKEN FOR A Health COUPLE OF Professional YEARS Date:03/22/01ISR Number: 3687985-6Report Type:Expedited (15-DaCompany Report #EMADSS2001001424 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Foreign Risperdal PS Janssen Research Fdn ORAL 10 MG, DAILY, Initial or Prolonged Formication Health ORAL Tongue Disorder Professional Zolpidem (Zolpidem) C Disipal (Orphenadrine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1004 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/22/01ISR Number: 3687986-8Report Type:Expedited (15-DaCompany Report #JACAN16646 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Crohn'S Disease Foreign Risperdal PS Janssen Research Fdn ORAL 1) 0.5 MG, Hospitalization - Rectal Haemorrhage Health DAILY, ORAL; Initial or Prolonged Professional 2) 1.5 MG, Disability DAILY, ORAL; Required 3) 1 MG, 2 IN Intervention to Trifluoperazine Prevent Permanent (Trifluoperazine) C Impairment/Damage Benztropine (Benztropine) C Moclobemide (Moclobemide) C Divalproex (Valproate Semisodium) C Docusate (Docusate) C Date:03/22/01ISR Number: 3687987-XReport Type:Expedited (15-DaCompany Report #NSADSS2001005434 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal PS Janssen Research Fdn ORAL 4 MG, 1 IN 1 Health DAY(S), ORAL Professional K-Dur (Potassium Chloride) C Clonazepam (Clonazepam) C Methotrimeprazine (Levomepromazine) C Lithium (Lithium) C Date:03/22/01ISR Number: 3687991-1Report Type:Expedited (15-DaCompany Report #NSADSS2001006935 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Above Consumer Risperdal PS Janssen Research Fdn ORAL 2 MG, 2 IN 1 Initial or Prolonged Therapeutic DAY(S), ORAL Disability Pneumonia Lithium (Lithium) SS ORAL 900 MG, Tongue Disorder DAILY, ORAL Tremor Synthroid (Levothyroxine Sodium) C Cogentin (Benzatropine Mesilate) C Neurontin (Gabapentin) C Depakote (Valproate Semisodium) C Date:03/22/01ISR Number: 3688045-0Report Type:Expedited (15-DaCompany Report #EMADSS2001001412 Age:77 YR Gender:Female I/FU:I Outcome Disability Required 22-Feb-2006 08:20 AM Page: 1005 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Nasal Septum Perforation Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG, 2 IN 1 Rhinitis Health DAY(S), ORAL Rhinorrhoea Professional Procyclidine (Procyclidine) C Thyroxine Na (Levothyroxine Sodium) C Bendrofluazide (Bendroflumethiazide ) C Senna (Senna) C Lactulose (Lactulose) C Frusemide (Furosemide) C Date:03/23/01ISR Number: 3689549-7Report Type:Expedited (15-DaCompany Report #256624 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Foreign Clonopin PS Hoffmann La Roche Initial or Prolonged Other Inc ORAL 45 DOSE FORM DAIL ORAL Clopixol - Slow Release (Clopenthixol) 200 Mg/Ml SS INTRAMUSCULAR 500 MG 2 PER MONTH INTRAMUSCULAR Risperdal (Risperidone) SS ORAL 6 MG DAILY ORAL Depakine Chrono (Valproate Sodium/Valproic Acid) 500 Mg SS ORAL 700 MG 3 PER DAY ORAL Date:03/26/01ISR Number: 3689734-4Report Type:Expedited (15-DaCompany Report #PHEH2001US01076 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Health Pamelor PS Novartis Professional Pharmaceuticals Corp ORAL 50 MG, QD, ORAL Risperdal (Risperidone) SS ORAL 3 MG, BID, ORAL Date:03/27/01ISR Number: 3690817-3Report Type:Expedited (15-DaCompany Report #EMADSS2001000865 Age:86 YR Gender:Male I/FU:F Outcome PT Death Dermatitis Gastrooesophageal Reflux 22-Feb-2006 08:20 AM Page: 1006 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disease Lip Ulceration Mouth Ulceration Oral Intake Reduced Report Source Product Role Manufacturer Route Dose Duration Pruritus Foreign Duragesic PS Alza Corp TRANSDERMAL 25 MCG, Skin Disorder Health TRANSD Toxic Epidermal Professional Risperdal (Tablet) Necrolysis (Risperidone) SS ORAL 1.5 MG, DAILY, ORAL Heminevrin (Clomethiazole Edisilate) SS 300 MG, DAILY Propavan (Propiomazine Maleate) SS ORAL 25 MG, DAILY, ORAL Mycostatin (Nystatin) SS 4 ML, DAILY Plavix (Clopidogrel Sulfate) SS ORAL 75 MG, DAILY, ORAL Lanzo (Lansoprazole) SS ORAL 30 MG, ORAL Imovane (Zopiclone) C Erco-Fer (Ferrous Fumarate) C Theo (Theophylline) C Spirololakton (Spironolactone) C Duphalac (Lactulose) C Date:03/30/01ISR Number: 3693434-4Report Type:Expedited (15-DaCompany Report #EMADSS2001000865 Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrooesophageal Reflux Foreign Risperdal PS Janssen Research Fdn ORAL 1.5 MG, Disease Health DAILY, ORAL Oral Intake Reduced Professional Durogesic (Patch) Respiratory Disorder (Fentanyl) SS TRANSDERMAL 25 MCG, Toxic Epidermal TRANSD Necrolysis Propavan (Propiomazine Maleate) SS ORAL 25 MG, DAILY, ORAL Plavix (Clopidogrel Sulfate) SS ORAL 75 MG, DAILY, ORAL Lanzo (Lansoprazole) SS ORAL 30 MG, ORAL Mycostatin (Nystatin) SS 4 ML, DAILY Heminevrin (Clomethiazole Edisilate) C 300 MG, DAILY Imovane (Zopiclone) C Erco-Fer (Ferrous Fumarate) C Theo (Theophylline) C Spironolakton (Spironolactone) C Duphalac (Lactulose) C 22-Feb-2006 08:20 AM Page: 1007 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/30/01ISR Number: 3693435-6Report Type:Expedited (15-DaCompany Report #EMADSS2001001307 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Foreign Risperdal PS Janssen Research Fdn ORAL 3 MG, DAILY, Hospitalization - Cystitis Health ORAL Initial or Prolonged Haemolytic Anaemia Professional Ciproxine Pyrexia (Ciprofloxacin) SS ORAL 500 MG, ORAL Renal Failure Trazolan Retard Stupor (Trazodone Systemic Lupus Hydrochloride) C Erythematosus Quitaxon (Doxepin Thrombotic Hydrochloride) C Thrombocytopenic Purpura Dominal (Prothipendyl Hydrochloride) C Tranxene (Clorazepate Dipotassium) C Ditropan (Oxybutynin) C Logastric (Omeprazole) C Zyrtec (Cetirizine Hydrochloride) C Date:03/31/01ISR Number: 3693565-9Report Type:Expedited (15-DaCompany Report #EMADSS2001001462 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL 0.5 MG, 3 IN Thrombocytopenia Health 1 DAILY, ORAL Professional Date:03/31/01ISR Number: 3693566-0Report Type:Expedited (15-DaCompany Report #EMADSS2001001468 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Foreign Risperdal (1 Mg Leukopenia Health Tablet) Professional (Risperidone) PS Janssen Research Fdn Date:03/31/01ISR Number: 3693567-2Report Type:Expedited (15-DaCompany Report #NSADSS2001008394 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Risperidone Initial or Prolonged Prolonged Literature (Unspecified) Torsade De Pointes Health (Risperidone) PS Janssen Research Fdn ORAL ORAL Professional Chlorpromazine Hydrochloride (Chlorpromazine) C Flunitrazepam (Flunitrazepam) C 22-Feb-2006 08:20 AM Page: 1008 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/31/01ISR Number: 3693568-4Report Type:Expedited (15-DaCompany Report #NSADSS2001008399 Age:48 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyskinesia Foreign Risperidone Throat Tightness Health (Unspecified) Professional (Risperidone) PS Janssen Research Fdn ORAL 0.5 MG, ORAL Quetiapine SS Date:04/03/01ISR Number: 3694955-0Report Type:Direct Company Report # Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Risperidone PS Initial or Prolonged Captopril C Ecotrin C Date:04/03/01ISR Number: 3695951-XReport Type:Expedited (15-DaCompany Report #2001AP01543 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyskinesia Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 400 MG DAILY Dysphagia Health PO Foreign Body Aspiration Professional Risperdal SS Other Rohypnol C Eurodin C Tasmolin C Date:04/05/01ISR Number: 3698638-2Report Type:Expedited (15-DaCompany Report #EMADSS2001001661 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Foreign Risperdal PS Janssen Research Fdn ORAL 13.5 MG, Life-Threatening Cardiac Arrest Health DAILY, ORAL Hospitalization - Cyanosis Professional Mitrazepin Initial or Prolonged (Mirtazapine) SS ORAL 30 MG, DAILY, Required ORAL Intervention to Ximovan(Zopiclone) SS ORAL 7.5 MG, Prevent Permanent DAILY, ORAL Impairment/Damage Ofiril (Valproate Sodium) SS ORAL 300 MG, DAILY, ORAL Falithrom(Phenprocou mon) C Arelix C Norvasc C Actraphane (Insulin Injection, Isophane) C Date:04/05/01ISR Number: 3698643-6Report Type:Expedited (15-DaCompany Report #EMADSS2001001634 Age:71 YR Gender:Male I/FU:I Outcome PT Life-Threatening C-Reactive Protein Hospitalization - Increased Initial or Prolonged Depressed Level Of Consciousness Oxygen Saturation 22-Feb-2006 08:20 AM Page: 1009 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Tachypnoea Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal PS Janssen Research Fdn ORAL 13.5 MG, Health DAILY, ORAL Professional Lorazepam(Lorazepam) SS ORAL 4 MG, DAILY, ORAL Date:04/05/01ISR Number: 3698648-5Report Type:Expedited (15-DaCompany Report #NSADSS2001009674 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG, 2 IN Thrombocytopenia Health DAILY, ORAL Professional Sertraline (Sertraline) C Lorazepam(Lorazepam) C Zopl C Milk Of Magnesia C Tylenol (Paracetmol) C Senokot (Senna Fruit) C Loxapine (Loxapine) C Date:04/05/01ISR Number: 3698709-0Report Type:Expedited (15-DaCompany Report #NSADSS2001009357 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperdal PS Janssen Research Fdn ORAL 6 MG, DAILY, Initial or Prolonged Hyponatraemia Health ORAL Water Intoxication Professional Quinapril (Quinapril) C Zopiclone (Zopiclone) C Clonazepam (Clonazepam) C Date:04/05/01ISR Number: 3698761-2Report Type:Expedited (15-DaCompany Report #EMADSS2001001678 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn Health Tercian Professional (Cyamemazidine) C Company Tegretol Representative (Carbamazepine) C Date:04/05/01ISR Number: 3698876-9Report Type:Direct Company Report # Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dysphagia Risperidone PS 1MG QHS Other Stridor Thioridazine Hcl C Docusate Ca C Psyllium Sf C Buspirone Hcl C Fluoxetine Hcl C 22-Feb-2006 08:20 AM Page: 1010 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Finasteride C Clonazepam C Benzonatate C Donepezil Hcl C Cefuroxime Axetil C Potassium Chloride C Furosemide C Ipratropium Bromide C Albuterol C Morphine Sulfate C Ceftriaxone C Famotidine C Lorazepam C Date:04/05/01ISR Number: 3699591-8Report Type:Expedited (15-DaCompany Report #M0157-2001 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Remeron PS Organon Inc Sub Hospitalization - Cyanosis Health Akzona Inc ORAL 75 MG/DAY PO Initial or Prolonged Foreign Body Aspiration Professional Risperidoen SS Required Sodium Valproate SS Intervention to Zopiclone SS Prevent Permanent Insulin/Isophane Impairment/Damage Insulin C Norvasc C Phenprocoumon C Piretanide Or Piretanide Sodium C Date:04/06/01ISR Number: 3698908-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Thioridazine PS ORAL 100 MG PO QHS Initial or Prolonged / LONG DURATION Risperidone SS 0 - 5MG Q PM Aspirin C Dig C Furosemide C Levothyroxine C Lisinopril C Lovastatin C Nitroglycerin C Kcl C Date:04/06/01ISR Number: 3700189-3Report Type:Expedited (15-DaCompany Report #S01-USA-00393-01 Age:38 YR Gender:Female I/FU:F Outcome PT Hospitalization - Abnormal Faeces Initial or Prolonged Colitis Ulcerative Dehydration Diarrhoea Haemorrhagic Haematocrit Decreased Haemoglobin Decreased Haemorrhage 22-Feb-2006 08:20 AM Page: 1011 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pain Rectal Haemorrhage Sinusitis Report Source Product Role Manufacturer Route Dose Duration Vomiting Health Celexa PS Forest Laboratories Professional Inc ORAL 40 MG QD PO Celexa (Citalopram Hydrobromide) SS ORAL 30 MG QD PO Neurontin (Gabapentin) SS Risperdal (Risperidone) SS Asacol (Mesalazine) SS Prednisone SS Date:04/09/01ISR Number: 3701498-4Report Type:Expedited (15-DaCompany Report #PHEH2001US01076 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Tardive Dyskinesia Health Pamelor PS Novartis Professional Pharmaceuticals Corp ORAL 50 MG, QD, ORAL Risperdal (Risperidone) SS ORAL 3 MG, BID, ORAL Date:04/10/01ISR Number: 3702183-5Report Type:Expedited (15-DaCompany Report #NSADSS2001009761 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Consumer Risperdal PS Janssen Research Fdn ORAL 1.5 MG, Life-Threatening Fluctuation DAILY, ORAL Hospitalization - Blood Sodium Increased Bactrim Ds (Bactrim) SS ORAL 2 IN 1 DAY Initial or Prolonged Condition Aggravated (S), ORAL Required Dehydration Symmetrel Intervention to Drug Ineffective (Amantadine Prevent Permanent Dystonia Hydrochloride) SS ORAL 100 MG, 2 IN Impairment/Damage Encephalopathy 1 DAY (S), Leukocytosis ORAL Malnutrition Norvasc (Amlodipine Multi-Organ Failure Besilate) C Muscle Rigidity Prilosec Neuroleptic Malignant (Omeprazole) C Syndrome Eldepryl (Selegiline Pneumonia Hydrochloride) C Respiratory Rate Fosamax (Alendronate Increased Sodium) C Tachycardia Urinary Incontinence Urinary Tract Infection Weight Decreased Date:04/10/01ISR Number: 3702185-9Report Type:Expedited (15-DaCompany Report #NSADSS2001009898 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal PS Janssen Research Fdn ORAL 2 MG, 1 IN 1 DAY (S), ORAL 22-Feb-2006 08:20 AM Page: 1012 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/10/01ISR Number: 3702188-4Report Type:Expedited (15-DaCompany Report #NSADSS2001010069 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:04/10/01ISR Number: 3702192-6Report Type:Expedited (15-DaCompany Report #NSADSS2001010073 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:04/10/01ISR Number: 3702198-7Report Type:Expedited (15-DaCompany Report #NSADSS2001010075 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mouth Haemorrhage Health Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Pancytopenia Professional Date:04/10/01ISR Number: 3702200-2Report Type:Expedited (15-DaCompany Report #NSADSS2001010130 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Movement Disorder Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Hospitalization - Muscle Rigidity Haldol (Injection) Initial or Prolonged Pneumonia (Haloperidol) SS INTRAMUSCULAR 2 MG, 1 IN 1 Tongue Disorder DAY (S), IM Weight Decreased Ativan (Lorazepam) C Date:04/10/01ISR Number: 3702623-1Report Type:Expedited (15-DaCompany Report #EMADSS2001001730 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Health Taxilan (Perazine) SS ORAL SEE IMAGE Professional Remergil (Mirtazapine) SS ORAL 30 MG, ORAL Neurocil (Levomepromazine Maleate) SS DOSE VARIED FROM 25-125 MG/DAY ON 17 MAY - 12 JUN; AND FROM Valproat Sodium (Valproate Sodium) C Fluracepam (Flurazepam) C Tranxillium (Clorazepate Dipotassium) C 22-Feb-2006 08:20 AM Page: 1013 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/10/01ISR Number: 3702624-3Report Type:Expedited (15-DaCompany Report #EMADSS2001001819 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal PS Janssen Research Fdn FREQUENCY AND Initial or Prolonged Health DOSE UNKNOWN Professional Tercian (Cyamemazine) C Date:04/10/01ISR Number: 3702625-5Report Type:Expedited (15-DaCompany Report #EMADSS2001001876 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination, Auditory Foreign Risperdal PS Janssen Research Fdn DOSAGE 0.5 MG Health - 1 MG DAILY Professional 0.5 MG SINCE 15-FEB-01. 11-MAR-01-1MG Digitalis Antitoxin (Digitalis-Sntitoxin ) SS Diuretikum (Dyazide) C Ace Hemmer (Captopril) C Date:04/10/01ISR Number: 3702627-9Report Type:Expedited (15-DaCompany Report #EMADSS2001001881 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Foreign Risperdal PS Janssen Research Fdn ORAL 6 MG, DAILY, Breast Mass Health ORAL Breast Pain Professional Date:04/11/01ISR Number: 3702524-9Report Type:Direct Company Report # Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperidone PS ORAL 4 MG, 2 MG Initial or Prolonged Phosphokinase Increased BID, ORAL Pyrexia Haloperidol C Date:04/11/01ISR Number: 3703236-8Report Type:Expedited (15-DaCompany Report #01P-163-0105441-00 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Sodium Increased Literature Norvir PS Abbott Laboratories 400 MG, 1 IN Intervention to Blood Urea Increased Health 1 D SEE IMAGE Prevent Permanent Convulsion Professional Ritonavir Soft Impairment/Damage Drug Interaction Gelatin Capsules Neuroleptic Malignant (Norvir) (Ritonavir) SS 200 MG, 1 IN Syndrome 1 D 8 DAY Risperidone (Risperidone) (Risperidone) SS Risperidone ( Risperidone) (Risperidone) SS 1.5 MG, 1 IN 1 D 22-Feb-2006 08:20 AM Page: 1014 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperidone (Risperidone) (Risperidone) SS 1 MG, 1 IN 1 D 2 DAY Indinavir (Indinavir) (Indinavir) SS 800 MG, 1 IN 1 D Indinavir (Indinavir) (Indinavir) SS 400 MG, 1 IN 1 D Sertraline (Sertraline) C Clonazepam (Clonazepam) C Ciprofloxacin (Ciprofloxacin) C Ethionamide (Ethionamide) C Ethambutol Dihydrochloride (Ethambutol Dihydrochloride) C Rifabutin (Rifabutin) C Fluconazole (Fluconazole) C Itraconazole (Itraconazole) C Clotrimazole (Clotrimazole) C Prednisone (Prednisone) C Morphine Sulfate (Morphine Sulfate) C Bactrim (Sulfamethoxazole, Trimethoprim) C Aciclovir (Aciclovir) C Lorazepam (Lorazepam) C Didanosine (Didanosine) C Abacavir C Date:04/11/01ISR Number: 3704163-2Report Type:Expedited (15-DaCompany Report #01P-056-0105030-00 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Foreign Depakene PS Abbott Laboratories Initial or Prolonged Health Pharmaceutical Professional Products Div ORAL 2100 MG, 1 IN 1 D, PER ORAL Risperidone (Risperidone) SS ORAL 6 MG, 1 IN 1 D, PER ORAL Zuclopenthixol Decanoate 22-Feb-2006 08:20 AM Page: 1015 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Zuclopenthixol Decanoate) SS ORAL 500 MG, 2 IN 1 M, PER ORAL Clonazepam (Clonazepam) SS ORAL 4.5 MG, 1 IN 1 D, PER ORAL Date:04/12/01ISR Number: 3703893-6Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Zyprexa "Olanzapine" Muscle Rigidity 2.5 Mg Eli Lilly PS Eli Lilly ORAL 2.5 MG BID Neuroleptic Malignant ORAL Syndrome Risperdol Pyrexia "Risperidal" SS ORAL 0.5 MG BID ORAL Date:04/12/01ISR Number: 3704278-9Report Type:Expedited (15-DaCompany Report #EMADSS2001001790 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG, 2 IN 1 Insomnia Health DAILY, ORAL Muscle Rigidity Professional Lactulose Posture Abnormal (Lactulose) C Salivary Hypersecretion Thioridazine (Thioridazine) C Date:04/12/01ISR Number: 3704279-0Report Type:Expedited (15-DaCompany Report #EMADSS2001001913 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Foreign Risperdal PS Janssen Research Fdn ORAL 0.5 MG, 2 IN Attack Health 1 DAILY, ORAL Professional Aspirin (Acetylsalicylic Acid) C Ferrous Sulphate (Ferrous Sulfate) C Thioridazine (Thioridazine) C Nitrazepam (Nitrazepam) C Date:04/12/01ISR Number: 3704280-7Report Type:Expedited (15-DaCompany Report #EMADSS2001001762 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Foreign Risperdal PS Janssen Research Fdn ORAL 3 MG, DAILY, Initial or Prolonged Study ORAL Health Professional 22-Feb-2006 08:20 AM Page: 1016 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/01ISR Number: 3704281-9Report Type:Expedited (15-DaCompany Report #EMADSS2001001474 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG, DAILY, Initial or Prolonged Convulsion Health ORAL Electroencephalogram Professional Tranxene Abnormal (Clorazepate Femur Fracture Dipotassium) C Hyponatraemia Mepronizine Medication Error (Mepronizine) C Sedation Lepticur Status Epilepticus (Tropatepine Hydrochloride) C Hept-A-Myl (Heptaminol Hydrochloride) C Clopixol (Zuclopenthixol Decnoate) C Theralene (Alimemazine Tartrate) C Smecta (Smecta) C Date:04/13/01ISR Number: 3704410-7Report Type:Direct Company Report # Age:84 YR Gender:Female I/FU:I Outcome PT Death Agitation Anaemia Atrophy Blood Sodium Increased Cardiac Failure Condition Aggravated Dehydration Drug Interaction Ecchymosis Electrocardiogram Abnormal Electrolyte Imbalance Extrapyramidal Disorder Fall Hallucination Lower Respiratory Tract Infection Malnutrition Medication Error Mental Disorder Due To A General Medical Condition Mental Impairment Multi-Organ Failure Mutism Nervous System Disorder Neuroleptic Malignant Syndrome Psychotic Disorder Pulmonary Oedema Renal Failure Respiratory Failure Rib Fracture 22-Feb-2006 08:20 AM Page: 1017 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Shock Urinary Tract Infection Ventricular Hypertrophy Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Risperdal / 0.5 Mg / 1.0 Mg Am/Pm / Janssen PS Janssen ORAL 0.5MG/1 AM/PM ORAL Risperdal 0.25mg/0.50 Mg Am/Pm Janssen SS Janssen ORAL 0/25/0.5MG AM/PM ORAL Symmetrel SS Amantadine -Symmetrel- C Eldepryl C Norvasc C Prevacid C Oscal C Date:04/13/01ISR Number: 3704646-5Report Type:Expedited (15-DaCompany Report #200012981DDC Age:92 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Electrolytes Foreign Furosemide (Lasix Initial or Prolonged Decreased Health Retard) PS Aventis Other Hypothermia Professional Pharmaceuticals Inc ORAL 30 MG/DAY PO Pancytopenia Thiamazole (Thacapzol) SS Risperidone (Risperdal) SS Zopiclone (Imovane) C Amiloride Hydrochloride (Midamor) C Colecalciferon, Calcium Carbonate (Calcichew D3) C Citalopram Hydrobromide (Cipramil) C Alendronate Sodium (Fosamax) C Date:04/16/01ISR Number: 3705596-0Report Type:Expedited (15-DaCompany Report #N128292 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrooesophageal Reflux Health Plavix PS Sanofi Synthelabo Hospitalization - Disease Professional Inc ORAL 75 MG PO 37 DAY Initial or Prolonged Respiratory Disorder Risperidal Toxic Epidermal (Risperidone) SS ORAL 5 MG PO 31 DAY Necrolysis Heminevrin (Clomethiazole Edisilate) SS 300 MG 24 DAY Propavan (Propiomazine Maleate) SS ORAL 25 MG PO 18 DAY Mycostatin Mixture (Nystatin) SS 400000 IU 9 DAY 22-Feb-2006 08:20 AM Page: 1018 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Durogesic (Fentanyl) SS TRANSDERMAL 25 MCG/"TIME" TD 25 DAY Lanzo (Lansoprazole) SS ORAL 30 MG PO 54 DAY Imovane (Zopiclone) C Erco-Fer(Ferrous Fumarate) C Theo-Dur (Theophylline) C Spironolactone Nm Pharma (Spironolactone) C Duphalac (Lactulose) C Date:04/18/01ISR Number: 3706330-0Report Type:Expedited (15-DaCompany Report #258262 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hepatic Steatosis Invirase PS Roche Risperdal SS Lipur SS Combivir SS Retrovir C Videx C Viramune C Epivir C Zerit C Date:04/18/01ISR Number: 3706470-6Report Type:Direct Company Report # Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Risperidone 4 Mg Bid PS ORAL 8 MG PO 15 DAY Drooling Chlorpheniramine Dysarthria Tabs C Gait Disturbance Tylenol C Vomiting Date:04/18/01ISR Number: 3707246-6Report Type:Expedited (15-DaCompany Report #NSADSS2001010881 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Janssen Research Fdn Date:04/18/01ISR Number: 3707248-XReport Type:Expedited (15-DaCompany Report #JRFUSA2000000095 Age:52 YR Gender:Male I/FU:F Outcome PT Hospitalization - Aggression Initial or Prolonged Akathisia Required Arthralgia Intervention to Asthenia Prevent Permanent Body Temperature Impairment/Damage Decreased Bone Marrow Depression Bradykinesia 22-Feb-2006 08:20 AM Page: 1019 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiac Arrest Chest Pain Confusional State Report Source Product Role Manufacturer Route Dose Duration Convulsion Consumer Risperdal (Tablet) Difficulty In Walking Health (Risperidone) PS Janssen Research Fdn ORAL 3 MG, 2 IN 1 Drug Withdrawal Syndrome Professional DAY(S), ORAL Dyskinesia Haldol (Tablet) Feeling Cold Haloperidol SS ORAL 2 MG, 4 IN 1 Headache DAY(S), ORAL Hyperhidrosis Ativan (Lorazepam) SS ORAL 2 MG, 4 IN 1 Leukopenia DAY(S), ORAL Memory Impairment Olanzapine Overdose (Olanzapine) C Parkinsonism Seroquel (Seroquel) C Psychotic Disorder Zyprexa (Olanzapine) C Pulse Absent Remeron Pyrexia (Mirtazapine) C Red Blood Cell Count Decreased Sleep Disorder Suicidal Ideation Tachycardia Tardive Dyskinesia Tremor Weight Decreased Date:04/18/01ISR Number: 3707257-0Report Type:Expedited (15-DaCompany Report #NSADSS2001010130 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Muscle Rigidity Consumer Haldol PS Rw Johnson Hospitalization - Pneumonia Pharmaceutical Initial or Prolonged Tongue Disorder Research Institute INTRAMUSCULAR 2 MG, 2 IN 1 Weight Decreased DAY, IM Risperdal (Unspecified) (Risperidone) SS ORAL ORAL Ativan (Lorazepam) C Date:04/18/01ISR Number: 3707561-6Report Type:Expedited (15-DaCompany Report #EMADSS2001002292 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laryngospasm Foreign Risperdal PS Janssen Research Fdn Health Professional Date:04/18/01ISR Number: 3707562-8Report Type:Expedited (15-DaCompany Report #EMADSS2001002225 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperthyroidism Foreign Risperdal PS Janssen Research Fdn ORAL 6 MG, DAILY, Health ORAL Professional Procyclidine (Procyclidine) C Lithium (Lithium) C 22-Feb-2006 08:20 AM Page: 1020 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/01ISR Number: 3707654-3Report Type:Expedited (15-DaCompany Report #NSADSS2001010816 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Encephalopathy Health Risperdal PS Janssen Research Fdn ORAL 0.5 MG, 1 IN Professional 1 DAY(S), ORAL Date:04/18/01ISR Number: 3707655-5Report Type:Expedited (15-DaCompany Report #NSADSS2001010884 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Consumer Risperdal PS Janssen Research Fdn ORAL 1 MG, 1 IN 1 Initial or Prolonged Lethargy DAY(S), ORAL Listless Insulin C Polymyalgia Rheumatica Glynase (Glybenclamide) C Vasotec (Enalapril Maleate) C Lanoxin (Digoxin) C Allopurinol C Date:04/18/01ISR Number: 3707789-5Report Type:Expedited (15-DaCompany Report #EMADSS2001002268 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Steatosis Foreign Risperdal PS Janssen Research Fdn DOSE AND Health FREQUENCY NOT Professional Lipur (Gemfibrozil) SS Invirase (Saquinavir) SS ORAL ORAL Combivir (Zidovudine W/Lamivudine) SS ORAL ORAL Retrovir C Videx (Didanosine) C Viramune (Nevirapine) C Epivir (Lamivudine) C Zerit (Stavudine) C Date:04/18/01ISR Number: 3707790-1Report Type:Expedited (15-DaCompany Report #EMADSS2001002300 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Flutter Foreign Risperdal PS Janssen Research Fdn ORAL 0.5 MG, Atrioventricular Block Health DAILY, ORAL Dyspnoea Professional Burinex A C Flat Affect Arthrotec C Oral Intake Reduced Flavoxate C Renal Impairment Nifedipine C Sedation Aspirin C Tachycardia 22-Feb-2006 08:20 AM Page: 1021 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/01ISR Number: 3707791-3Report Type:Expedited (15-DaCompany Report #EMADSS2001002351 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL 0.5 MG, Health DAILY, ORAL Professional Paroxetine C Furosemide (Furosemide) C Date:04/18/01ISR Number: 3707792-5Report Type:Expedited (15-DaCompany Report #EMADSS2001002353 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fatigue Foreign Risperdal PS Janssen Research Fdn 1 MG, 1 IN 1 Study DAILY, Health Floxyfral Professional (Fluvoxamine Maleate) C Adalat (Nifedipine) C Zaroxolyn C Date:04/18/01ISR Number: 3707793-7Report Type:Expedited (15-DaCompany Report #NSADSS2001008394 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Risperdal PS Janssen Research Fdn ORAL 6 MG, DAILY, Initial or Prolonged Cardiac Arrest Literature ORAL Required Chromosome Abnormality Health Haldol (Unspecified0 Intervention to Electrocardiogram Qt Professional (Haloperidol) SS 7.5 MG, Prevent Permanent Prolonged DAILY, Impairment/Damage Myocarditis Chlorpromazine Oral Intake Reduced Hydrochloride Pneumonia (Chlorpromazine Torsade De Pointes Hydrochloride) SS 300 MG, DAILY Ventricular Tachycardia Flunitrazepam C Levomepromazine C Date:04/19/01ISR Number: 3707400-3Report Type:Expedited (15-DaCompany Report #B0103418A Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hepatic Steatosis Combivir PS Glaxo Wellcome ORAL 41 DAY Hepatitis B Antibody Combivir SS Glaxo Wellcome ORAL Abnormal Gemfibrozil SS ORAL Hepatocellular Damage Risperidone SS ORAL Saquinavir SS ORAL Lamivudine C Glaxo Wellcome ORAL Zidovudine C Glaxo Wellcome ORAL 598 DAY Didanosine C ORAL 598 DAY Nevirapine C ORAL Stavudine C ORAL 22-Feb-2006 08:20 AM Page: 1022 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/19/01ISR Number: 3708220-6Report Type:Expedited (15-DaCompany Report #2001AP01543 Age:48 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyskinesia Foreign Seroquel PS Astrazeneca Uk Ltd ORAL 50 MG DAILY Hospitalization - Dysphagia Health PO Initial or Prolonged Injury Asphyxiation Professional Seroquel "Zeneca" SS ORAL 75 MG DAILY Tardive Dyskinesia Other PO Seroquel "Zeneca" SS ORAL 100 MG DAILY PO Seroquel "Zeneca" SS ORAL 200 MG DAILY PO Seroquel "Zeneca" SS ORAL 300 MG DAILY PO Seroquel "Zeneca" SS ORAL 400 MG DAILY PO Risperdal SS ORAL 6 MG DAILY PO Risperdal SS ORAL 4 MG DAILY PO Risperdal SS ORAL 3.5 MG DAILY PO Risperdal SS ORAL 3 MG DAILY PO Risperdal SS ORAL 2.5 MG DAILY PO Risperdal SS ORAL 2 MG DAILY PO Risperdal SS ORAL 1 MG DAILY PO Risperdal SS ORAL 0.5 MG DAILY PO Rohypnol C Eurodin C Tasmolin C Date:04/19/01ISR Number: 3708311-XReport Type:Expedited (15-DaCompany Report #258262 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Alanine Aminotransferase Foreign Invirase PS Hlr Technology ORAL ORAL Increased Other Risperdal Aspartate (Risperidone) SS ORAL ORAL Aminotransferase Lipur (Gemfibrozil) SS Increased Combivir Blood Amylase Increased (Lamivudine/Zidovudi Hepatic Steatosis ne) SS ORAL ORAL Lipase Increased Retrovir (Zidovudine) C Videx (Didanosine) C Viramune (Nevirapine) C Epivir (Lamuvidine) C Zerit (Stavudine) C Date:04/20/01ISR Number: 3709118-XReport Type:Expedited (15-DaCompany Report #9621760 Age: Gender:Female I/FU:F Outcome Life-Threatening Hospitalization - Initial or Prolonged Other Required Intervention to 22-Feb-2006 08:20 AM Page: 1023 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Cardio-Respiratory Arrest Consumer Navane PS Roerig Div Pfizer Cholecystectomy Health Inc ORAL 5.00 MG Intentional Overdose Professional TOTAL: ORAL Other Cogentin SS ORAL 1.00 MG TOTAL: DAILY: ORAL Verapamil SS ORAL ORAL Risperdal SS ORAL 6.00 MG TOTAL: BID: ORAL Nortriptyline C Date:04/23/01ISR Number: 3708874-4Report Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chest Pain Risperdal / Janssen PS Janssen Date:04/23/01ISR Number: 3709284-6Report Type:Expedited (15-DaCompany Report #NSADSS2001008394 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Haldol PS Rw Johnson Initial or Prolonged Cardiac Arrest Literature Pharmaceutical Required Chromosome Abnormality Health Research Institute Intervention to Decreased Appetite Professional Div Ortho Pharm 7.5 MG DIALY Prevent Permanent Electrocardiogram Qt Risperidone Impairment/Damage Prolonged (Unspecified) Myocarditis (Risperidone) SS ORAL SEE IMAGE Oral Intake Reduced Chlorpromazine Pneumonia Hydrochloride Torsade De Pointes (Chlorpromazine Ventricular Tachycardia Hydrochloride) SS SEE IMAGE Flunitrazepam (Flunitrazepam) C Levomepromazine (Levomepromazine) C Date:04/24/01ISR Number: 3710493-0Report Type:Direct Company Report # Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Risperdal PS DC'D PRIOR TO Syndrome ARRIVAL AT Pyrexia BENEFIS Celexa SS ORAL 20 MG PO QD Levothyroxine C Date:04/24/01ISR Number: 3710542-XReport Type:Expedited (15-DaCompany Report #NSADSS2001011239 Age:38 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 1024 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Colectomy Total Health Risperdal PS Janssen Research Fdn Colitis Ulcerative Professional Celexa (Citalopram Dehydration Hydrobromide) SS ORAL SEE IMAGE Haematocrit Decreased Neurontin Haemoglobin Decreased (Gabapentin) SS Laboratory Test Abnormal Sinusitis Vomiting Date:04/24/01ISR Number: 3710545-5Report Type:Expedited (15-DaCompany Report #NSADSS2001011334 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:04/24/01ISR Number: 3710583-2Report Type:Expedited (15-DaCompany Report #EMADSS2001002426 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Foreign Risperdal PS Janssen Research Fdn UNKNOWN Health Professional Date:04/24/01ISR Number: 3710586-8Report Type:Expedited (15-DaCompany Report #NSADSS2001011135 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG, DAILY, Initial or Prolonged Haemorrhagic Stroke Health ORAL Disability Orthostatic Hypotension Professional Milnacipran Subdural Haematoma Hydrochloride (Milnacipran) SS ORAL 30 MG , DAILY, ORAL Estazolam (Estazolam) C Date:04/24/01ISR Number: 3710588-1Report Type:Expedited (15-DaCompany Report #EMADSS2001001762 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Foreign Risperdal PS Janssen Research Fdn ORAL 0.5 MG Initial or Prolonged Study DAILY, ORAL Health SEE IMAGE Professional Selegin (Selegiline) C Madopar (Madopar) C Eunerpan (Melperone Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1025 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/24/01ISR Number: 3710591-1Report Type:Expedited (15-DaCompany Report #EMADSS2001002313 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Foreign Risperdal PS Janssen Research Fdn ORAL 2.5 MG , ORAL Overdose Date:04/24/01ISR Number: 3710728-4Report Type:Expedited (15-DaCompany Report #033-0719-M0100005 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Steatosis Foreign Lopid PS Parke Davis Consumer Pharmaceuticals Ltd Other Riperidone (Risperidone) SS ORAL PER ORAL Invirase (Saquinavir) SS Zidovudine /Lamvudine (Lamivudine, Azidovudine) SS ORAL PER ORAL Didanosine (Didanosine) C Nevirapine (Nevirapine) C Stavudine (Stavudine) C Date:04/25/01ISR Number: 3711005-8Report Type:Expedited (15-DaCompany Report #NSADSS2001011846 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Electrocardiogram Qt Health Risperdal PS Janssen Research Fdn ORAL 4 MG, 1 IN 1 Corrected Interval Professional DAY(S), ORAL; Prolonged Company 2 MG, 1 IN 1 Representative DAY(S), ORAL Celexa(Citalopram Hydrobromide) C Date:04/25/01ISR Number: 3711006-XReport Type:Expedited (15-DaCompany Report #NSADSS2001011938 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Date:04/25/01ISR Number: 3711007-1Report Type:Expedited (15-DaCompany Report #NSADSS2001012049 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Dementia Alzheimer'S Type 22-Feb-2006 08:20 AM Page: 1026 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/01ISR Number: 3711008-3Report Type:Expedited (15-DaCompany Report #NSADSS2001012050 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal PS Janssen Research Fdn ORAL 3 MG, 1 IN 1 Professional DAY(S), ORAL Date:04/25/01ISR Number: 3711152-0Report Type:Expedited (15-DaCompany Report #NSADSS2001011598 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:04/25/01ISR Number: 3711244-6Report Type:Expedited (15-DaCompany Report #2001AP01543 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyskinesia Foreign Seroquel PS Astrazeneca Lp ORAL SEE IMAGE Hospitalization - Dysphagia Health Risperdal SS ORAL SEE IMAGE Initial or Prolonged Injury Asphyxiation Professional Rohypnol C Required Tardive Dyskinesia Other Eurodin C Intervention to Tasmolin C Prevent Permanent Impairment/Damage Date:04/25/01ISR Number: 3711353-1Report Type:Expedited (15-DaCompany Report #EMADSS2001002531 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Risperdal PS Janssen Research Fdn Initial or Prolonged Exposure To Therapeutic Health Paroxetine Other Drugs Professional (Paroxetine) SS Convulsion Neonatal Drug Withdrawal Syndrome Neonatal Feeling Jittery Date:04/25/01ISR Number: 3711354-3Report Type:Expedited (15-DaCompany Report #EMADSS2001001410 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Red Blood Cell Count Foreign Risperdal PS Janssen Research Fdn ORAL ORAL Decreased Health Professional Date:04/25/01ISR Number: 3711366-XReport Type:Expedited (15-DaCompany Report #B0103418A Age:36 YR Gender:Male I/FU:I Outcome PT Disability Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Amylase Increased Hepatic Steatosis 22-Feb-2006 08:20 AM Page: 1027 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatocellular Damage Lipase Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Combivir PS Glaxo Wellcome Inc ORAL ORAL Gemfibrozil SS ORAL ORAL Risperidone SS ORAL ORAL Saquinavir SS ORAL ORAL Lamivudine C Zidovudine C Didanosine C Nevirapine C Stavudine C Date:04/25/01ISR Number: 3711528-1Report Type:Expedited (15-DaCompany Report #2001AP01543 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyskinesia Foreign Seroquel PS Astrazeneca Lp ORAL 50 MG DAILY Hospitalization - Dysphagia Health PO Initial or Prolonged Injury Asphyxiation Professional Seroquel "Zeneca" SS Zeneca ORAL 75 MG DAILY Required Tardive Dyskinesia Other PO Intervention to Seroquel "Zeneca" SS Zeneca ORAL 100 MG DAILY Prevent Permanent PO Impairment/Damage Seroquel "Zeneca" SS Zeneca ORAL 200 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 300 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 400 MG DAILY PO Risperdal SS ORAL 6 MG DAILY PO Risperdal SS ORAL 4 MG DAILY PO Risperdal SS ORAL 3.5 MG DAILY PO Risperdal SS ORAL 3 MG DAILY PO Risperdal SS ORAL 2.5 MG DAILY PO Risperdal SS ORAL 2 MG DAILY PO Risperdal SS ORAL 1 MG DAILY PO Risperdal SS ORAL 0.5 MG DAILY PO Rohypnol C Eurodin C Tasmolin C Date:04/26/01ISR Number: 3711901-1Report Type:Expedited (15-DaCompany Report #001-0945-M0100486 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Colitis Ulcerative Health Neurontin PS Parke Davis Initial or Prolonged Dehydration Professional Pharmaceuticals Ltd UNKNOWN Other Diarrhoea Haemorrhagic Celexa (Citalopram Required Haematocrit Decreased Hydrobromide) SS ORAL DAILY PER Intervention to Haemoglobin Decreased ORAL Prevent Permanent Pain Risperdal Impairment/Damage Rectal Haemorrhage (Risperidone) SS UNKNOWN Vomiting Asacol (Mesalazine) SS UNKNOWN Prednisone (Prednisone) SS UNKNOWN 22-Feb-2006 08:20 AM Page: 1028 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Solu-Medrol (Methylprednisolone Sodium Succinate) SS UNKNOWN Cyclosporine SS UNKNOWN Date:04/26/01ISR Number: 3711912-6Report Type:Expedited (15-DaCompany Report #A107661 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Health Geodon PS Pfizer Central Intervention to Anxiety Professional Research ORAL 40.00 MG Prevent Permanent Bundle Branch Block Right TOTAL BID Impairment/Damage Constipation ORAL Electrocardiogram Risperidone SS Abnormal Thorazine C Electrocardiogram Qt Asa C Prolonged Lorazepam C Insomnia Vitamin B12 C Pain Neutra-Phos C Lithium C Tylenol C Cogentin C Chloral Hydrate C Mom With Cascara C Fleet Enema C Hydrocortisone C Sebulex C Olanzepine C Mevacor C Imodium C Phenolated Resorcinol C Terbinafine C Date:04/27/01ISR Number: 3713516-8Report Type:Expedited (15-DaCompany Report #EMADSS2001002292 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dystonia Foreign Risperdal PS Janssen Research Fdn Other Injury Asphyxiation Health Diazepam C Laryngospasm Professional Respiratory Disorder Date:04/27/01ISR Number: 3713517-XReport Type:Expedited (15-DaCompany Report #NSADSS2001008394 Age:50 YR Gender:Female I/FU:F Outcome PT Hospitalization - Asthenia Initial or Prolonged Cachexia Required Cardiac Arrest Intervention to Electrocardiogram Qt Prevent Permanent Prolonged Impairment/Damage Inflammation Myocarditis Oral Intake Reduced Pneumonia Respiratory Disorder Schizophrenia 22-Feb-2006 08:20 AM Page: 1029 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Torsade De Pointes Ventricular Tachycardia Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal PS Janssen Research Fdn ORAL 2MG, DAILY, Literature ORAL Health Haldol (Unspecified) Professional (Haloperidol) SS 7.5; 5.25 MG, DAILY Chlorpormazine Hydrochloride SS 300; 200; 300 MG, DAILY Flunitrazepam C Levomepromazine C Date:04/27/01ISR Number: 3713570-3Report Type:Expedited (15-DaCompany Report #NSADSS2001011939 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL 0.5ML, 1 IN 1 Professional DAY(S), ORAL Date:05/01/01ISR Number: 3714400-6Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blood Pressure Increased Risperdal PS 0.25 MG AT Blood Pressure Systolic BEDTIME Increased Accupril C Condition Aggravated Lasix C Coordination Abnormal Aspirin C Crying Premarin C Depressed Mood Difficulty In Walking Repetitive Speech Date:05/01/01ISR Number: 3714401-8Report Type:Direct Company Report # Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Increased Risperdal PS 0.5 MG, ONE Life-Threatening Cognitive Disorder DOSE ONLY Hospitalization - Lung Neoplasm Malignant Initial or Prolonged Morose Disability Date:05/01/01ISR Number: 3714403-1Report Type:Direct Company Report # Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Asthenia Risperdal PS 10-15 DAYS Balance Disorder Condition Aggravated Difficulty In Walking 22-Feb-2006 08:20 AM Page: 1030 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/01ISR Number: 3714488-2Report Type:Direct Company Report # Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Risperidone PS Date:05/01/01ISR Number: 3714529-2Report Type:Direct Company Report # Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Risperidal (4mg) PS 4MG AT Dizziness BEDTIME Drug Level Above Depakote (250mg) SS 750MG TWICE Therapeutic DAILY Flushing Hyperventilation Date:05/01/01ISR Number: 3714622-4Report Type:Expedited (15-DaCompany Report #NSADSS2001012517 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombosis Health Risperdal 7-Day Professional Starter Pack PS Janssen Research Fdn ORAL 4 MG, DAILY, ORAL Coumadin C Date:05/01/01ISR Number: 3714625-XReport Type:Expedited (15-DaCompany Report #NSADSS2001009898 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Consumer Risperdal PS Janssen Research Fdn ORAL 2 MG, 1 IN 1 DAY(S), ORAL Remeron C Effexor C Xanax C Asthma Inhaler C Date:05/01/01ISR Number: 3714627-3Report Type:Expedited (15-DaCompany Report #NSADSS2001010069 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL UNK, ORAL Professional Date:05/01/01ISR Number: 3714628-5Report Type:Expedited (15-DaCompany Report #NSADSS2001008379 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Risperdal PS Janssen Research Fdn ORAL 1 MG, 2 IN 1 Hospitalization - Foreign Body Trauma Professional DAILY, ORAL Initial or Prolonged 22-Feb-2006 08:20 AM Page: 1031 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/01ISR Number: 3715178-2Report Type:Expedited (15-DaCompany Report #EMADSS2001002636 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Encephalopathy Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG, 2 IN 1 Initial or Prolonged Hyponatraemia Health DAILY, ORAL Muscle Contractions Professional Depakine (Valproate Involuntary Sodium) SS ORAL 200 MG, 2 IN 1 DAILY, ORAL Deprax (Trazodone Hydrochloride) SS ORAL 100 MG, 2 IN 1, ORAL Distraneurine (Clomethiazole Edisilate) SS ORAL 192 MG, 2 IN 1, ORAL Zyprexa (Olanzapine) SS ORAL 10 MG, DAILY, ORAL Date:05/03/01ISR Number: 3717151-7Report Type:Expedited (15-DaCompany Report #EMADSS2001000885 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG, DAILY, Neutropenia Health ORAL Professional Lovenox (Heparin-Fraction, Sodium Salt) C Seropram (Citalopram Hydrobromide) C Amoxicillin (Amoxicillin) C Date:05/03/01ISR Number: 3717155-4Report Type:Expedited (15-DaCompany Report #EMADSS2001001462 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG, DAILY, Cystitis Health ORAL Leukopenia Professional Phenytoin Myeloid Metaplasia (Phenytoin) C Thrombocytopenia Antibiotic C Date:05/03/01ISR Number: 3717156-6Report Type:Expedited (15-DaCompany Report #EMADSS2001002686 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL 3 MG, DAILY, Thrombocytopenia Health ORAL Professional Akineton (Biperiden Hydrochloride) C Date:05/03/01ISR Number: 3717418-2Report Type:Expedited (15-DaCompany Report #001-0945-M0100522 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Other Priapism Literature Health 22-Feb-2006 08:20 AM Page: 1032 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Neurontin PS Parke Davis Pharmaceuticals Ltd 900 MG (DAILY) Risperidone (Risperidone) SS 6 MG (DAILY) Olanzapine (Olanzapine) SS 7.5 MG (DAILY) Fluvoxamine (Fluvoxamine) SS 300 MG (DAILY) Oxazepam (Oxazepam) SS 25 MG (DAILY) Date:05/03/01ISR Number: 3717541-2Report Type:Expedited (15-DaCompany Report #NSADSS2001009003 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Risperdal PS Janssen Research Fdn Decreased Professional Date:05/03/01ISR Number: 3717543-6Report Type:Expedited (15-DaCompany Report #NSADSS2001012656 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Health Risperdal PS Janssen Research Fdn ORAL 1 MG, 1 IN 1 Initial or Prolonged Drug Toxicity Professional DAY(S), ORAL Myocarditis Pleural Effusion Date:05/03/01ISR Number: 3717553-9Report Type:Expedited (15-DaCompany Report #NSADSS2001003698 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Delirium Professional Lithium (Lithium) SS ORAL ORAL Required Diabetes Insipidus Intervention to Thrombotic Prevent Permanent Thrombocytopenic Purpura Impairment/Damage Date:05/04/01ISR Number: 3717606-5Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Risperidone PS Initial or Prolonged Syndrome Pneumonia 22-Feb-2006 08:20 AM Page: 1033 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/04/01ISR Number: 3717931-8Report Type:Expedited (15-DaCompany Report #EMADSS2001002703 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Circulatory Collapse Foreign Risperdal PS Janssen Research Fdn ORAL 0.5 MG, 2 IN Condition Aggravated Health 1 DAY(S), Drug Interaction Professional ORAL Sinus Bradycardia Amiodarone (Amiodarone) SS Frusemide (Furosemide) C Pravastatin C Captropril C Losec (Omeprazole) C Clopidrogrel C Date:05/04/01ISR Number: 3717934-3Report Type:Expedited (15-DaCompany Report #EMADSS2001001819 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal PS Janssen Research Fdn ORAL 4 MG, DAILY, Initial or Prolonged Pyrexia Health ORAL Professional Tercian (Cyamemazine) SS Tenormin (Atenolol) C Coversyl (Perindopril) C Seresta (Oxazepam) C Date:05/04/01ISR Number: 3717937-9Report Type:Expedited (15-DaCompany Report #NSADSS2001002459 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal PS Janssen Research Fdn ORAL 12 MG, DAILY, Initial or Prolonged Phosphokinase Increased Health ORAL; 9 MG, 6 Other Condition Aggravated Professional MG, 12 MG, 9 Delirium MG, 6 MG, 1 Dysarthria IN 1 DAY(S), Dysphagia Impromen C Hallucination, Auditory Thioridazine C Hyperhidrosis Levomepromaxine Insomnia Maleate C Leukopenia Trihexyphenidyl Nasopharyngitis Hydrochloride C Pyrexia Lorazepam C Salivary Hypersecretion Gloriamin C Schizophrenia Nitrazepam C Sedation Levofloxacin Urinary Incontinence (Tablet) C Magnesium Oxide C Flunitrazepam C Perphenazine C Date:05/04/01ISR Number: 3718056-8Report Type:Expedited (15-DaCompany Report #NSADSS2001008461 Age:25 YR Gender:Female I/FU:I Outcome PT Other Hyperprolactinaemia Platelet Count Decreased 22-Feb-2006 08:20 AM Page: 1034 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thrombocytopenia Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal PS Janssen Research Fdn ORAL 7 MG DAILY, Health ORAL Professional Lithium (Lithium) C Date:05/04/01ISR Number: 3718192-6Report Type:Expedited (15-DaCompany Report #NSADSS2001008394 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Haldol PS Rw Johnson Initial or Prolonged Cachexia Literature Pharmaceutical Required Cardiac Arrest Health Research Institute Intervention to Chromosome Analysis Professional Div Ortho Pharm 7.5; 5.25 MG, Prevent Permanent Abnormal DAILY Impairment/Damage Electrocardiogram Qt Risperidone Prolonged (Risperidone) SS ORAL 2; 12; 5; 9 Inflammation MG, DAILY, Myocarditis ORAL Oral Intake Reduced Chlorpromazine Pneumonia Hydrochloride Respiratory Disorder (Chlorpromazine Schizophrenia Hydrochloride) SS 300; 200; 300 Torsade De Pointes MG, DAILY Ventricular Tachycardia Flunitrazepam (Flunitrazepam) C Levomepromazine (Levomepromazine) C Date:05/07/01ISR Number: 3719046-1Report Type:Expedited (15-DaCompany Report #NSADSS2001008399 Age:48 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Foreign Risperdal PS Janssen Research Fdn ORAL ORAL 0.5 MG, Alanine Aminotransferase Health ORAL SEE Increased Professional IMAGE Aspartate Quetiapine Aminotransferase (Quetiapine) SS 400 MG Increased Biperiden Blood Lactate Hydrochloride Dehydrogenase Increased (Biperiden Cardio-Respiratory Arrest Hydrochloride) C Dyskinesia Flunitrazepam Foreign Body Aspiration (Flunitrazepam) C Hallucination, Auditory Estazolam Restlessness (Estazolam) C Date:05/08/01ISR Number: 3719381-7Report Type:Direct Company Report # Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Pain Lower Depakote PS ORAL PO 250MG Q AM Intervention to Blood Amylase Increased 325HS Prevent Permanent Risperidol SS 1 MG BID Impairment/Damage 22-Feb-2006 08:20 AM Page: 1035 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/09/01ISR Number: 3720415-4Report Type:Expedited (15-DaCompany Report #FLUV00301001982 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Literature Luvox PS Solvay Initial or Prolonged Pharmaceuticals ORAL 300 MG DAILY PO Risperidone (Risperidone) SS 6 MG DAILY Olanzapine (Olanzapine) C 7.5 MG DAILY Date:05/09/01ISR Number: 3721165-0Report Type:Expedited (15-DaCompany Report #10824720 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Encephalopathy Desyrel PS Apothecon Inc Div Hospitalization - Hyponatraemia Bristol Myers Squibb ORAL 100 Initial or Prolonged Muscle Contractions MILLIGRAM, Involuntary ORAL Depakine (Valproate Sodium) SS ORAL 200 MILLIGRAM, ORAL Risperdal (Risperidone) SS 1 MILLIGRAM, ORAL Distraneurine (Chlormethiazole) SS ORAL 192 MILLIGRAM, ORAL Zyprexa (Olanzapine) SS ORAL 100 MILLIGRAM, ORAL Date:05/11/01ISR Number: 3721926-8Report Type:Expedited (15-DaCompany Report #NSADSS2001013200 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Consumer Risperdal PS Janssen Research Fdn ORAL 2 MG, 1 IN 1 Required Small Intestinal DAY, ORAL Intervention to Perforation Prevent Permanent Impairment/Damage Date:05/11/01ISR Number: 3721960-8Report Type:Expedited (15-DaCompany Report #NSADSS2001013210 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1036 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/01ISR Number: 3721962-1Report Type:Expedited (15-DaCompany Report #NSADSS2001011334 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:05/11/01ISR Number: 3722524-2Report Type:Expedited (15-DaCompany Report #00P-062-0097019-00 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Depakene PS Abbott Laboratories Initial or Prolonged Confusional State Literature Pharmaceutical Coordination Abnormal Health Products Div ORAL 600 MG, 1 Dizziness Professional IN 1 D, Drug Interaction PER ORAL Drug Level Above Doxepin Therapeutic Hydrochloride Electroencephalogram (Doxepin Abnormal Hydrochloride) Encephalopathy (Doxepin SS ORAL 200 MG, 1 Fall IN 1 D, PER Fatigue ORAL Grand Mal Convulsion Risperidone Nausea (Risperidone) Psychomotor Retardation (Risperidone) SS ORAL 4 MG, 1 Sedation IN 1 D, Tremor PER ORAL Biperiden Hydrochloride (Bisperiden Hydrochloride) (Biperiden SS ORAL 4 MG, 1 IN 1 D, PER ORAL Lorazepam (Lorazepam) (Lorazepam) C Date:05/11/01ISR Number: 3722528-XReport Type:Expedited (15-DaCompany Report #EMADSS2001002032 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG, DAILY, Health ORAL Professional Date:05/14/01ISR Number: 3724087-4Report Type:Expedited (15-DaCompany Report #10824720 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Encephalopathy Foreign Desyrel PS Apothecon Inc Div Hospitalization - Hyponatraemia Health Bristol Myers Squibb ORAL 200 Initial or Prolonged Muscle Contractions Professional MILLIGRAMS, 1 Involuntary Other DAY ORAL Depakine (Valproate Sodium) SS ORAL 200 MILLIGRAM, 2/1 DAY ORAL 22-Feb-2006 08:20 AM Page: 1037 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal (Risperidone) SS ORAL 2 MILLIGRAM, 1 DAY ORAL Distraneurine (Chlormethiazole) SS ORAL 194 MILLIGRAM, 2/1 DAY ORAL Zyprexa (Olanzapine) SS ORAL 10 MILLIGRAM, 1 DAY ORAL Date:05/15/01ISR Number: 3723654-1Report Type:Expedited (15-DaCompany Report #JACGER2000001747 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Disorder Foreign Risperdal PS Janssen Research Fdn ORAL MG, DAILY, Leukopenia Health ORAL Thrombocytopenia Professional Date:05/16/01ISR Number: 3724172-7Report Type:Direct Company Report # Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Risperidone PS Initial or Prolonged Date:05/17/01ISR Number: 3724360-XReport Type:Direct Company Report #USP 54048 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Risperdal PS Janssen Blood Test Abnormal Difficulty In Walking Disorientation Encephalopathy Medication Error Parkinson'S Disease Date:05/17/01ISR Number: 3724473-2Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Haloperidol PS INTRAVENOUS 1MG IV Q 6H Hospitalization - Confusional State PRN Initial or Prolonged Drug Ineffective Risperidone SS Required Hypertension Lorazepam C Intervention to Multiple Sclerosis Ranitidine C Prevent Permanent Pyrexia Naficillin C Impairment/Damage Tachycardia Lactalose C Mvi C Thiamine C Folate C Heparin C 22-Feb-2006 08:20 AM Page: 1038 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/01ISR Number: 3724651-2Report Type:Expedited (15-DaCompany Report #NSADSS2001014105 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Health Risperdal PS Janssen Research Fdn ORAL 0.5 MG, 2 IN Initial or Prolonged Professional 1 DAY(S), Other ORAL Li Co4 (Lithium Carbonate) C Date:05/17/01ISR Number: 3724652-4Report Type:Expedited (15-DaCompany Report #NSADSS2001014037 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Risperdal PS Janssen Research Fdn ORAL 0.5 MG, 3 IN Congestive 1 DAY(S), Pneumonia ORAL Renal Failure Date:05/17/01ISR Number: 3724749-9Report Type:Expedited (15-DaCompany Report #NSADSS2001008394 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Foreign Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Chromosome Abnormality Literature Haldol (Unspecified) Required Electrocardiogram Qt Health (Haloperidol) SS SEE IMAGE Intervention to Prolonged Professional Chlorpromazine Prevent Permanent Myocarditis Hydrochloride Impairment/Damage Oral Intake Reduced (Chlorpromazine Pneumonia Hydrochloride) SS SEE IMAGE Torsade De Pointes Flunitrazepam Ventricular Tachycardia (Flunitrazepam) C Levomepromazine (Levomepromazine) C Date:05/17/01ISR Number: 3724750-5Report Type:Expedited (15-DaCompany Report #EMADSS2001002353 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fatigue Foreign Risperdal PS Janssen Research Fdn 1 MG, 1 IN 1 Study DAILY Health Floxyfral Professional (Fluvoxamine Maleate) C Adalat (Nifedipine) C Zaroxolyn (Metolazone) C Date:05/18/01ISR Number: 3725963-9Report Type:Expedited (15-DaCompany Report #EMADSS2001002032 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG, DAILY, Health ORAL Professional 22-Feb-2006 08:20 AM Page: 1039 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/01ISR Number: 3725965-2Report Type:Expedited (15-DaCompany Report #EMADSS2001002906 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG, 2 IN 1 Initial or Prolonged Health DAY(S), ORAL Required Professional Mepronizine Intervention to (Mepronizine) SS ORAL 1 CAP, DAILY, Prevent Permanent ORAL Impairment/Damage Buspar (Buspirone Hydrochloride) SS DOSE AND FREQUENCY Ixel (Milnacipran) SS ORAL 2 CAP, DAILY, ORAL Athymil (Mianserin Hydrochloride) SS ORAL 30 MG, 1 IN 1 DAY(S), ORAL Seropram (Citalopram Hydrobromide) SS ORAL 1, DAILY, ORAL Xanax (Alprazolam) C Date:05/18/01ISR Number: 3726213-XReport Type:Expedited (15-DaCompany Report #NSADSS2001013450 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pericarditis Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG, DAILY, Health ORAL Professional Date:05/18/01ISR Number: 3726214-1Report Type:Expedited (15-DaCompany Report #NSADSS2001013504 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Foreign Risperdal PS Janssen Research Fdn Health Seroquel (Seroquel) C Professional Date:05/18/01ISR Number: 3726274-8Report Type:Expedited (15-DaCompany Report #NSADSS2001011598 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Risperdal PS Janssen Research Fdn ORAL 1 MG, 3 IN Professional DAILY, ORAL Donnatal (Donnatal) C Exelon (Rivastigmine) C Zosyn (Pip / Tazo) C Detrol (Tolterodine L-Tartrate) C Verapamil (Verapamil) C Coumadin (Warfarin Sodium) C Clonazepam (Clonazepam) C Lanoxin (Digoxin) C Niacin (Nicotinic Acid) C 22-Feb-2006 08:20 AM Page: 1040 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tylenol W/Codeine No. 3 (Tablet) (Acetaminophen / Codeine) C Benadryl (Diphenhydramine Hydrochloride) C Pepcid (Famotidine) C St John'S Wort (Hypericum Perforatum) C Date:05/18/01ISR Number: 3726275-XReport Type:Expedited (15-DaCompany Report #NSADSS2001013757 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL 1 MG, 2 IN Professional DAILY, ORAL Date:05/18/01ISR Number: 3726276-1Report Type:Expedited (15-DaCompany Report #NSADSS2001013893 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:05/18/01ISR Number: 3726277-3Report Type:Expedited (15-DaCompany Report #NSADSS2001013711 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Haemorrhage Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Company Representative Date:05/18/01ISR Number: 3726278-5Report Type:Expedited (15-DaCompany Report #NSADSS2001013623 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL UNK, ORAL Professional Date:05/21/01ISR Number: 3726436-XReport Type:Expedited (15-DaCompany Report #NSADSS2001014532 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angle Closure Glaucoma Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Topamax (Unspecified) (Topiramate) SS Effexor (Venlafaxine Hydrochloride) SS 22-Feb-2006 08:20 AM Page: 1041 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/01ISR Number: 3726437-1Report Type:Expedited (15-DaCompany Report #NSADSS2001010073 Age:84 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Risperdal PS Janssen Research Fdn ORAL ORAL Hospitalization - Pulmonary Disease Professional Initial or Prolonged Respiratory Arrest Date:05/21/01ISR Number: 3726659-XReport Type:Periodic Company Report #PHEH2001US00582 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Exelon PS Novartis Initial or Prolonged Convulsion Professional Pharmaceuticals Corp ORAL 6 MG, BID, Salivary Hypersecretion ORAL Sedation Risperdal Risperidone) SS ORAL ORAL Citalopram (Citalopram) C Date:05/21/01ISR Number: 3726818-6Report Type:Expedited (15-DaCompany Report #NSADSS2001013504 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Foreign Risperdal PS Janssen Research Fdn Health Seroquel (Seroquel) SS ORAL ORAL Professional Date:05/21/01ISR Number: 3726819-8Report Type:Expedited (15-DaCompany Report #EMADSS2001001661 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Foreign Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Life-Threatening Cardiac Arrest Health Mitrazapin Hospitalization - Coma Professional (Mirtazapine) SS ORAL SEE IMAGE Initial or Prolonged Cyanosis Ofiril (Valproate Required Foreign Body Aspiration Sodium) SS ORAL SEE IMAGE Intervention to Ximovan (Zopiclone) SS ORAL 7.5 MG, Prevent Permanent DAILY, ORAL Impairment/Damage Falithrom (Phenproccumon) C Arelix(Piretanide) C Norvasc(Amlodipine Besilate) C Actraphane(Insulin Injection, Isophane) C Date:05/21/01ISR Number: 3726948-9Report Type:Expedited (15-DaCompany Report #S01-FRA-00940-01 Age:43 YR Gender:Male I/FU:I Outcome PT Hospitalization - Bronchial Obstruction Initial or Prolonged Dehydration Hyperhidrosis Prostration Respiratory Distress Rhabdomyolysis Serotonin Syndrome 22-Feb-2006 08:20 AM Page: 1042 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Foreign Celexa PS Forest Laboratories Health Inc ORAL 20 MG QD PO Professional Mepronizine SS ORAL 1 TABLET QD Other PO Buspar (Buspirone Hydrochloride) SS Ixel (Milnacipran) SS ORAL 2 CAPSULE QD PO Athymil (Mianserin Hydrochloride) SS ORAL 30 MG QD PO Risperidal (Risperidone) SS ORAL 2 MG QD PO Atarax (Hydroxyzine Hydrochloride) C Nozinan (Levomepromazine) C Xanax (Alprazolam) C Date:05/22/01ISR Number: 3727237-9Report Type:Expedited (15-DaCompany Report #NSADSS2001011232 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Risperdal PS Janssen Research Fdn ORAL 2 MG, 2 IN 1 Initial or Prolonged Professional DAY (S), ORAL Date:05/22/01ISR Number: 3727523-2Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Macular Risperdal (1mg Bid) (Janssen) PS Janssen ORAL 1MG BID PO Zoloft C Clean Nasal Spray C Date:05/24/01ISR Number: 3728439-8Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Risperidal PS ORAL 1 MG PO BID Hallucination Allegra C Codeine C Vioxx C Aciphex C Detrol La C Quinine C Date:05/24/01ISR Number: 3728596-3Report Type:Expedited (15-DaCompany Report #NSADSS2001008394 Age:50 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:20 AM Page: 1043 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Foreign Haldol PS Rw Johnson Cardiac Arrest Literature Pharmaceutical Electrocardiogram Qt Health Research Institute Prolonged Professional Div Ortho Pharm 7.5 MG, DAILY Myocarditis (SEE IMAGE) Oral Intake Reduced Risperidone Pneumonia (Risperidone) SS ORAL 2 MG, DAILY, Ventricular Tachycardia ORAL (SEE IMAGE) Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS 300 MG, DAILY (SEE IMAGE) Flunitrazepam (Flunitrazepam) C Levomepromazine (Levomepromazine) C Date:05/24/01ISR Number: 3728685-3Report Type:Expedited (15-DaCompany Report #PHNU2001DE01252 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Exelon PS Novartis Dizziness Health Pharmaceuticals Corp ORAL 1.5 MG, BID, Hallucination Professional ORAL Tachycardia Other Digimerck Therapeutic Agent (Digitoxin) SS ORAL 0.1 MG, BID, Toxicity ORAL Isoptin (Verapamil Hydrochloride) SS ORAL ORAL Risperdal (Risperidone) SS ORAL 2.5 MG/DAY, ORAL Date:05/24/01ISR Number: 3728698-1Report Type:Expedited (15-DaCompany Report #PHBS2001DE04939 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Binge Eating Foreign Clozaril PS Novartis Hunger Literature Pharmaceuticals Corp 500 MG/D Weight Increased Health Risperidone(Risperid Professional one) SS Other Date:05/25/01ISR Number: 3729363-7Report Type:Expedited (15-DaCompany Report #EMADSS2001001634 Age:71 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Foreign Risperdal PS Janssen Research Fdn ORAL 13.5 MG, Hospitalization - Depressed Level Of Health DAILY, ORAL; Initial or Prolonged Consciousness Professional 6 MG DAILY, Overdose ORAL Tachypnoea Lorazepam (Lorazepam) SS ORAL 4 MG, DAILY, 22-Feb-2006 08:20 AM Page: 1044 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Biperidan (Biperiden) SS ORAL 8 MG, DAILY, ORAL Ramipril (Ramipril) C Digotoxin (Digotoxin) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Zyloric (Allopurinol) C Methizol (Thiamazol) C Fluannxol (Flupentixol) C Date:05/25/01ISR Number: 3729364-9Report Type:Expedited (15-DaCompany Report #NSADSS2001014801 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sleep Apnoea Syndrome Foreign Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Health Haldol (Unspecified) Professional (Haloperidol) C Lactulose (Lactulose) C Fluconazole (Fluconazole) C Phenergan (Promethazine Hydrochloride) C Coloxyl (Docusate Sodium) C Panadeine Forte Panadeine Co) C Chlorhexidine (Chlorhexidine) C Nilstat (Nyastatin) C Microlax (Microlax) C Date:05/25/01ISR Number: 3729387-XReport Type:Expedited (15-DaCompany Report #EMADSS2001002169 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn Health Depakine (Valproate Professional Sodium) C Date:05/29/01ISR Number: 3729001-3Report Type:Expedited (15-DaCompany Report #260859 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Klonopin Tablets PS Roche Initial or Prolonged Neurontin SS Risperdal SS Cogentin SS Lopressor C Heparin C Inderal C Pepcid C 22-Feb-2006 08:20 AM Page: 1045 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Asa C Date:05/29/01ISR Number: 3729873-2Report Type:Expedited (15-DaCompany Report #NSADSS2001015458 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coagulopathy Consumer Risperdal PS Janssen Research Fdn ORAL 3 MG, 1 IN 1 Embolism DAY(S), ORAL Date:05/29/01ISR Number: 3729875-6Report Type:Expedited (15-DaCompany Report #NSADSS2001008379 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Removal Of Foreign Body Health Risperdal PS Janssen Research Fdn ORAL 1 MG, 2 IN 1 Hospitalization - From Throat Professional DAY(S), ORAL Initial or Prolonged Respiratory Arrest Date:05/29/01ISR Number: 3730185-1Report Type:Expedited (15-DaCompany Report #S01-FRA-00940-01 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchial Obstruction Foreign Celexa PS Forest Laboratories Initial or Prolonged Dehydration Health Inc ORAL 20 MG QD PO Neuroleptic Malignant Professional Mepronizine SS ORAL 1 TABLET QD Syndrome Other PO Oxygen Saturation Buspar (Buspirone Decreased Hydrochloride) SS Prostration Ixel (Milnacipran) SS ORAL 2 CAPSULE QD Rales PO Respiratory Distress Athymil (Mianserin Salivary Hypersecretion Hydrochloride) SS ORAL 30 MG QD PO Serotonin Syndrome Risperdal Tremor (Risperidone) SS ORAL 2 MG QD PO Atarax (Hydroxyzine Hydrochloride) C Nozinan (Levomepromazine) C Xanax (Alprazolam) C Date:05/29/01ISR Number: 3730478-8Report Type:Expedited (15-DaCompany Report #EMADSS2001001970 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Face Oedema Foreign Risperdal PS Janssen Research Fdn RISPERIDONE Myocardial Infarction Health HAD BEEN Oedema Peripheral Professional TAKEN OVER SEVERAL MONTHS Fluvoxamine (Fluvoxamine) C Oxazepam (Oxazepam) C 22-Feb-2006 08:20 AM Page: 1046 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/01ISR Number: 3730480-6Report Type:Expedited (15-DaCompany Report #EMADSS2001002723 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn Health Tercian Professional (Cyamemazine) C Depakine (Valproate Sodium) C Imovane (Zopiclone) C Date:05/30/01ISR Number: 3730953-6Report Type:Expedited (15-DaCompany Report #A108295 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Geodon PS Pfizer Central Initial or Prolonged Chest Pain Professional Research Required Heart Rate Increased Risperidone SS Intervention to Panic Attack Prevent Permanent Impairment/Damage Date:05/30/01ISR Number: 3731182-2Report Type:Expedited (15-DaCompany Report #NSADSS2001014532 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angle Closure Glaucoma Health Topamax PS Rw Johnson Professional Pharmaceutical Research Institute Risperdal (Unspecified) (Risperidone) SS ORAL ORAL Effexor (Venlafaxine Hydrochloride) SS Date:05/31/01ISR Number: 3731374-2Report Type:Expedited (15-DaCompany Report #260859 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Health Klonopin PS Hoffmann La Roche Initial or Prolonged Hyporeflexia Professional Inc ORAL 6 MG DAILY ORAL Neurontin (Gabapentin) SS 800 MG DAILY Risperdal (Risperidone) SS 4 MG DAILY Cogentin (Benztropine Mesylate) SS 2 MG DAILY Lopressor (Metoprolol Tartrate) C Heparin (Heparin Sodium) C Inderal (Propranolol Hydrochloride) C Pepcid (Famotidine) C Asa (Aspirin) C 22-Feb-2006 08:20 AM Page: 1047 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/01ISR Number: 3731280-3Report Type:Direct Company Report # Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Movement Disorder Lithium PS Varries/Month To Tremor Month ORAL 250MG/AM/PM/O RAL Risperdal SS ORAL 1MG/ 2 TIMES/ORAL Date:06/01/01ISR Number: 3732665-1Report Type:Expedited (15-DaCompany Report #EMADSS2001003283 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Foreign Risperdal Neutropenia Health (Risperidone) PS Janssen Research Fdn 6 MG, DAILY Professional Sertraline C Date:06/01/01ISR Number: 3732667-5Report Type:Expedited (15-DaCompany Report #EMADSS2001002222 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Stevens-Johnson Syndrome Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Janssen Research Fdn 2 MG, DAILY Date:06/04/01ISR Number: 3733556-2Report Type:Periodic Company Report #A109949 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accidental Overdose Health Geodon PS Pfizer Central Mydriasis Professional Research Company Risperdal SS Representative Luvox SS Date:06/05/01ISR Number: 3733813-XReport Type:Direct Company Report # Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Risperdal (3mg) Initial or Prolonged Rash Macular (Janssen) PS Janssen ORAL 3MG BID PO Date:06/05/01ISR Number: 3734138-9Report Type:Expedited (15-DaCompany Report #NSADSS2001008394 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Cardiac Arrest Literature Haldol (Unspecified) Required Decreased Appetite Health (Haloperidol) SS SEE IMAGE Intervention to Dehydration Professional Chlorpromazine Prevent Permanent Electrocardiogram Qt Hydrochloride Impairment/Damage Prolonged (Chlorpromazine Myocarditis Hydrochlorride) SS SEE IMAGE Pneumonia Flunitrazepam Torsade De Pointes (Flunitrazepam) C Ventricular Tachycardia Levomepromazine (Levomepromazine) C 22-Feb-2006 08:20 AM Page: 1048 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/01ISR Number: 3734140-7Report Type:Expedited (15-DaCompany Report #NSADSS2001013450 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pericarditis Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG, DAILY, Health ORAL Professional Date:06/05/01ISR Number: 3734141-9Report Type:Expedited (15-DaCompany Report #NSADSS2001009357 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Hyponatraemia Health Quinapril Necrosis Professional (Quinapril) C Nervous System Disorder Zopiclone Polydipsia (Zopiclone) C Water Intoxication Clonazepam (Clonazepam) C Date:06/05/01ISR Number: 3734144-4Report Type:Expedited (15-DaCompany Report #EMADSS2001003405 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Risperdal PS Janssen Research Fdn ORAL 8, DAILY, Initial or Prolonged Pulmonary Embolism Health ORAL Professional Nozinan Company (Levomepromazine) C Representative Lexomil (Bromazepam) C Athymil (Mianserin Hydrochloride) C Stilnox (Zolpidem) C Date:06/05/01ISR Number: 3734146-8Report Type:Expedited (15-DaCompany Report #EMADSS2001003256 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Risperdal PS Janssen Research Fdn THERAPY START Initial or Prolonged Health AND STOP Professional DATES Antidepressant C Date:06/05/01ISR Number: 3734644-7Report Type:Expedited (15-DaCompany Report #EMADSS2001003220 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal PS Janssen Research Fdn ORAL 4 MG, DAILY, Vertigo Health ORAL Professional Tardyferon B9 Company (Tardyferon B9) C Representative 22-Feb-2006 08:20 AM Page: 1049 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/01ISR Number: 3734645-9Report Type:Expedited (15-DaCompany Report #JRFBEL1999000535 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Foreign Risperdal PS Janssen Research Fdn ORAL MG, DAILY, Aspiration Health ORAL Constipation Professional Linton (Unspecified) (Haloperidol) C Trihexyphenidyl (Trihexyphenidyl) C Amantadine Hydrochloride (Amantadine Hydrochloride) C Flunitrazepam (Flunitrazepam) C Vegetamiin A (Vegetamin A) C Halosten (Unspecified) (Haloperidol) C Date:06/05/01ISR Number: 3734864-1Report Type:Expedited (15-DaCompany Report #NSADSS2001013623 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL 5 MG, DAILY, Hospitalization - Professional ORAL Initial or Prolonged Prozac (Fluoxetine Required Hydrochloride) C Intervention to Neurontin Prevent Permanent (Gabapentin) C Impairment/Damage Date:06/05/01ISR Number: 3734866-5Report Type:Expedited (15-DaCompany Report #NSADSS2001015850 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:06/05/01ISR Number: 3734867-7Report Type:Expedited (15-DaCompany Report #NSADSS2001015831 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Risperdal PS Janssen Research Fdn ORAL 1 MG, 1 IN 1 Initial or Prolonged Dehydration DAY(S), ORAL Lethargy Urinary Tract Infection Date:06/05/01ISR Number: 3735567-XReport Type:Expedited (15-DaCompany Report #NSADSS2001016334 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Health Duragesic PS Alza Corp TRANSDERMAL TRANSD Professional Risperdal (Tablet) (Risperidone) SS ORAL 1) 3 MG, 2 IN 1 DAILY, 22-Feb-2006 08:20 AM Page: 1050 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL; 2) 2, DAILY, ORAL Phazyme (Phazyme) C Prilosec (Omeprazole) C Pancrease Mt (Pancrelipase) C Oscal(Calcium Carbonate) C Prempro (Provette / Generic/ ) C Date:06/06/01ISR Number: 3734824-0Report Type:Direct Company Report # Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Count Risperdal 0.5mg Increased Jansen PS Jansen ORAL BID PO Epistaxis Dexedrine C Prothrombin Time Livostin C Prolonged Rhinitis Seasonal Date:06/06/01ISR Number: 3735097-5Report Type:Expedited (15-DaCompany Report #NSADSS2001009674 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG, 2 IN Initial or Prolonged Thrombocytopenic Purpura Health DAILY, ORAL Other Leukopenia Professional Sertraline C Lorazepam C Zopl C Milk Of Magnesia (Magnesium Hydroxide) C Tylenol (Paracetamol) C Senokot (Senna Fruit) C Loxapine C Date:06/06/01ISR Number: 3735098-7Report Type:Expedited (15-DaCompany Report #NSADSS2001014682 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG, 1 IN 1 Initial or Prolonged Dizziness Literature DAY(S), ORAL Dysarthria Health Biperiden Dysphagia Professional Hydrochloride Extrapyramidal Disorder (Biperiden Gastrointestinal Motility Hydrochloride) C Disorder Flunitrazepam Hallucination (Flunitrazepam) C Oral Intake Reduced Levothyreoxine Pyrexia Sodium Salivary Hypersecretion (Levothyroxine Sedation Sodiuim) C Thirst Desmopressin Acetate (Desmopressin 22-Feb-2006 08:20 AM Page: 1051 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acetate) C Date:06/06/01ISR Number: 3736015-6Report Type:Expedited (15-DaCompany Report #NSADSS2001008766 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Health Risperdal PS Janssen Research Fdn ORAL 2 MG, 1 IN Ecchymosis Professional DAILY, ORAL Petechiae Mellaril (Thioridazine Hydrochloride) C Date:06/11/01ISR Number: 3737209-6Report Type:Periodic Company Report #2000-08-2046 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Consumer Claritin PS Schering Corp Sub Sexual Dysfunction Schering Plough Corp ORAL UNKNOWN ORAL Risperdal SS Dilantin SS 600 MG UNKNOWN Lithium SS 1200 MG UNKNOWN Date:06/11/01ISR Number: 3737232-1Report Type:Periodic Company Report #2000-09-0925 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Claritin PS Schering Corp Sub Dyspnoea Professional Schering Plough Corp ORAL ORAL Other Risperdal SS Date:06/11/01ISR Number: 3737485-XReport Type:Expedited (15-DaCompany Report #NSADSS2001005494 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Foreign Risperdal PS Janssen Research Fdn ORAL 3 MG, 1 IN 1 Gynaecomastia Health DAY(S), ORAL Neutropenia Professional Risperdal (Tablet) (Risperidone) SS 2 MG, 1 IN 1 DAY(S), ORAL Date:06/11/01ISR Number: 3737928-1Report Type:Expedited (15-DaCompany Report #NSADSS2001009175 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Abnormal Behaviour Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Cryptorchism Tic Weight Increased 22-Feb-2006 08:20 AM Page: 1052 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/13/01ISR Number: 3738003-2Report Type:Direct Company Report # Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Risperidone PS 1.5 MG Q AM Vomiting AND HS; 1 MG Q 2PM Trazodone C Date:06/13/01ISR Number: 3738073-1Report Type:Direct Company Report # Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bradycardia Metoprolol PS 50MG BID 3 MON Dizziness Risperidone SS ORAL .5MG PO QHS 4 MON Fall Upper Limb Fracture Date:06/13/01ISR Number: 3739048-9Report Type:Expedited (15-DaCompany Report #EMADSS2001003643 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL 3 MG, DAILY, Health ORAL Professional Tercian C Date:06/13/01ISR Number: 3739567-5Report Type:Expedited (15-DaCompany Report #NSADSS2001016929 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:06/13/01ISR Number: 3739569-9Report Type:Expedited (15-DaCompany Report #NSADSS2001017221 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn Professional Date:06/13/01ISR Number: 3739571-7Report Type:Expedited (15-DaCompany Report #NSADSS2001017224 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Risperdal PS Janssen Research Fdn ORAL 2 MG, 2 IN 1 Emphysema Professional DAILY, ORAL Date:06/15/01ISR Number: 3740172-5Report Type:Expedited (15-DaCompany Report #260859 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Klonopin Tablets PS Roche 17 DAY Initial or Prolonged Neurontin SS 28 DAY Risperdal SS 28 DAY Cogentin C 28 DAY Lopressor C 22-Feb-2006 08:20 AM Page: 1053 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heparin C Inderal C Pepcid C Asa C TAKEN WITH A MEAL. Isordil C Flomax C TAKEN AT BEDTIME. Colace C Lotrimin Cream 1% C 14 DAY Date:06/18/01ISR Number: 3740656-XReport Type:Expedited (15-DaCompany Report #261918 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Valium PS Roche 6 DAY Consciousness Fortovase SS Roche 176 DAY Hypertonia Norvir SS 176 DAY Pyrexia Combivir SS 176 DAY Risperdal SS 116 DAY Ziagen SS 176 DAY Date:06/18/01ISR Number: 3740693-5Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchospasm Risperidone PS ORAL 1MG Q 12H 1MG Initial or Prolonged Urticaria Q12H ORALLY Required Lorazepam C Intervention to Clonidine C Prevent Permanent Propranolol C Impairment/Damage Doxepin C Fluoxetine C Date:06/18/01ISR Number: 3741508-1Report Type:Expedited (15-DaCompany Report #260859 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Health Clonopin PS Hoffmann La Roche Initial or Prolonged Hyporeflexia Professional Inc ORAL 2 MG 2 PER DAY ORAL Neurontin (Gabapentin) 400 Mg SS ORAL 400 MG 2 PER DAY ORAL Risperdal (Risperdal) 2 Mg SS ORAL 2 MG 2 PER DAY ORAL Cogentin (Benztropine Mesylate) C Lopressor (Metoprolol Tartrate) C Heparin (Heparin Sodium) C Inderal (Propranolol Hydrochloride) C Pepcid (Famotidine) C 22-Feb-2006 08:20 AM Page: 1054 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Asa (Aspirin) C Isordil (Isosorbide Dinitrate) C Flomax (Tamsulosin Hydrochloride) C Colace (Docusate Sodium) C Lotrimin Cream 1% (Clotrimazole) C Date:06/18/01ISR Number: 3741946-7Report Type:Expedited (15-DaCompany Report #2001AP01543 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Foreign Seroquel PS Astrazeneca Lp ORAL 50 MG DAILY Hospitalization - Dyskinesia Health PO Initial or Prolonged Dysphagia Professional Seroquel "Zeneca" SS Zeneca ORAL 75 MG DAILY Required Injury Asphyxiation Other PO Intervention to Tardive Dyskinesia Seroquel "Zeneca" SS Zeneca ORAL 100 MG DAILY Prevent Permanent PO Impairment/Damage Seroquel "Zeneca" SS ORAL 200 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 300 MG DAILY PO Seroquel "Zeneca" SS Zeneca ORAL 400 MG DAILY PO Risperdal SS ORAL 6 MG DAILY PO Risperdal SS ORAL 4 MG DAILY PO Risperdal SS ORAL 3.5 MG DAILY PO Risperdal SS ORAL 3 MG DAILY PO Risperdal SS ORAL 2.5 MG DAILY PO Risperdal SS ORAL 2 MG DAILY PO Risperdal SS ORAL 1 MG DAILY PO Risperdal SS ORAL 0.5 MG DAILY PO Rohypnol C Eurodin C Tasmolin C Date:06/18/01ISR Number: 3742232-1Report Type:Periodic Company Report #LBID00201001255 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Consumer Lithobid PS Solvay Pharmaceuticals ORAL PO Luvox (Fluvoxamine Maleate) SS ORAL PO, PO Risperdal (Risperidone) SS ORAL PO Date:06/18/01ISR Number: 3742274-6Report Type:Periodic Company Report #LBID00200005485 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Paraesthesia Oral Consumer Lithobid PS Solvay Pharmaceuticals ORAL 300 MG DAILY 22-Feb-2006 08:20 AM Page: 1055 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report PO Risperdal (Risperidone) SS ORAL 0.5 MG DAILY PO, 0.25 MG DAILY PO Synthroid (Levothyroxine Sodium) C Date:06/18/01ISR Number: 3742501-5Report Type:Periodic Company Report #LBID00201001823 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorgasmia Consumer Lithobid PS Solvay Pharmaceuticals ORAL 300 MG QD PO Risperdal (Risperidone) SS ORAL 1 MG DAILY PO Estrace (Estradiol) C Levoxyl (Levothyroxine Sodium) C Atenolol ( Atenolol) C Furosemide (Furosemide) C Detrol (Tolterodine L-Tartrate) C Date:06/19/01ISR Number: 3742378-8Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Risperdal Oral Solution 1mg/Ml Janssen Pharmaceutical PS Janssen Pharmaceutical Date:06/19/01ISR Number: 3743143-8Report Type:Expedited (15-DaCompany Report #EMADSS2001003684 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Risperdal PS Janssen Research Fdn Electrocardiogram Qt Health Doliprane Prolonged Professional (Paracetamol) SS Augmentin (Clavulin) SS ORAL ORAL Nicobion 500 (Nicotinamide) SS Speciafoldine (Folic Acid) SS Seresta (Oxazepam) SS ORAL ORAL Date:06/19/01ISR Number: 3743146-3Report Type:Expedited (15-DaCompany Report #NSADSS2001017793 Age:56 YR Gender:Female I/FU:I Outcome Death Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 1056 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Acute Leukaemia Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG, 1 IN 1 Coma Health DAY(S), ORAL Convulsion Professional Remeron Haematoma (Mirtazapine) C Haemorrhage Intracranial Date:06/19/01ISR Number: 3743148-7Report Type:Expedited (15-DaCompany Report #NSADSS2001018037 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Risperidone PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Exposure To Therapeutic Health Antipsychotics, Nos Drugs Professional (Antipsychotics) SS Neonatal Asphyxia Date:06/19/01ISR Number: 3743150-5Report Type:Expedited (15-DaCompany Report #NSADSS2001008394 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG, DAILY, Initial or Prolonged C-Reactive Protein Literature ORAL (SEE Required Increased Health IMAGE) Intervention to Cardiac Arrest Professional Haldol (Unspecified) Prevent Permanent Decreased Appetite (Haloperidol) SS 7.5 MG, DAILY Impairment/Damage Electrocardiogram Qt (SEE IMAGE) Prolonged Chlorpromazine Inflammation Hydrochloride Myocarditis (Chlorpromazine Pneumonia Hydrochloride) SS 300 MG, DAILY Torsade De Pointes (SEE IMAGE) Ventricular Tachycardia Flunitrazepam (Flunitrazepam) C Levomepromazine (L-Evomepromazine) C Date:06/19/01ISR Number: 3743259-6Report Type:Expedited (15-DaCompany Report #NSADSS2001017866 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:06/20/01ISR Number: 3743596-5Report Type:Expedited (15-DaCompany Report #NSADSS2001017040 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Literature Risperdal PS Janssen Research Fdn ORAL 6 MG, DAILY, Initial or Prolonged Potentiation Health ORAL Priapism Professional Fluvoxamine (Fluvoxamine) SS ORAL 300 MG, DAILY, ORAL Olanzapine (Olanzapine) SS ORAL 7.5 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1057 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gabapentin (Gabapentin) C Oxazepam (Oxazepam) C Date:06/20/01ISR Number: 3743614-4Report Type:Expedited (15-DaCompany Report #HQ2184418JUN2001 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angle Closure Glaucoma Health Effexor Xr PS Wyeth Ayerst Professional Laboratories ORAL APPROXIMATELY 225 MG DAILY, ORAL Risperdal (Risperidone, ) SS ORAL ORAL Topamax (Topiramate, ) SS ORAL 25 MG 1X PER 1 DAY, ORAL Unspecified Antihypertensive Agent C Date:06/20/01ISR Number: 3743730-7Report Type:Expedited (15-DaCompany Report #261918 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Depressed Level Of Foreign Valium PS Hoffmann La Roche Intervention to Consciousness Other Inc 10 MG DAILY Prevent Permanent Hypertonia Fortovase Impairment/Damage Pyrexia (Saquinavir Mesylate) SS ORAL 400 MG DAILY ORAL Norvir (Ritonavir) SS 800 MG DAILY Combivir (Lamivudine/Zidovudi ne) SS DOSE FORM DAILY Risperdal (Risperidone) SS 4 MG DAILY Ziagen (Abacavir Sulfate) SS 2 DOSE FORM DAILY Date:06/20/01ISR Number: 3743735-6Report Type:Expedited (15-DaCompany Report #NSADSS2001018471 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL ORAL Health Professional Date:06/20/01ISR Number: 3743736-8Report Type:Expedited (15-DaCompany Report #NSADSS2001018587 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG, 2 IN Health DAILY ORAL Professional Lithium (Lithium) C 22-Feb-2006 08:20 AM Page: 1058 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/01ISR Number: 3743531-XReport Type:Direct Company Report # Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukopenia Risperdal Janssen PS Janssen 4 MG BID PO Seroquel SS 200 MG TID PO Ferrous Sulfate C Reg Insulin C Chronulac C Multivitamin C Actos C Haldol C Date:06/21/01ISR Number: 3744313-5Report Type:Expedited (15-DaCompany Report #S01-USA-01166-01 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Health Celexa PS Forest Laboratories Hospitalization - Blood Potassium Decreased Professional Inc ORAL 20 MG QD PO Initial or Prolonged Blood Sodium Decreased Other Risperdal Catatonia (Risperidone) SS Encephalopathy Opiods (Nos) SS Neuroleptic Malignant Muscle Relaxants Syndrome (Nos) SS Overdose Levothyroxine C Platelet Count Decreased Date:06/21/01ISR Number: 3744876-XReport Type:Expedited (15-DaCompany Report #NSADSS2001008394 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Haldol PS Rw Johnson Initial or Prolonged Cachexia Literature Pharmaceutical Required Cardiac Arrest Health Research Institute Intervention to Dehydration Professional Div Ortho Pharm 7.5 MG, DAILY Prevent Permanent Electrocardiogram Qt 5.25 MG, Impairment/Damage Prolonged DAILY Myocarditis Risperidone Oral Intake Reduced (Unspecified) Pneumonia (Risperidone) SS ORAL 2 MG, DAILY, Torsade De Pointes ORAL/12 MG, Ventricular Tachycardia DAILY, ORAL/ 5 MG DAILY, ORAL 3 MG, Chlorpromazine Hydrochloride SS 300 MG, DAILY/ 200 MG DAILY/300 MG, DAILY Flunitrazepam C Levomepromazine C Date:06/22/01ISR Number: 3744051-9Report Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 1059 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Depression Accutane 40 Mg Self Mutilation Roche PS Roche 2 CAPSULES Suicidal Ideation DAILY Risperdal 1mg SS 1 TABLET BEDTIME Paxil C Date:06/22/01ISR Number: 3745508-7Report Type:Expedited (15-DaCompany Report #A108295 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Geodon PS Pfizer Central Initial or Prolonged Chest Pain Professional Research ORAL 60.00 MG Required Condition Aggravated TOTAL:BID:ORA Intervention to Delusion L Prevent Permanent Heart Rate Increased Risperidone SS Impairment/Damage Panic Attack Date:06/22/01ISR Number: 3745512-9Report Type:Expedited (15-DaCompany Report #001-0945-M0100486 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorectal Disorder Health Neurontin PS Pfizer Inc Initial or Prolonged Colitis Ulcerative Professional Celexa (Citalopram Other Dehydration Hydrobromide) SS ORAL DAILY, PER Required Diarrhoea Haemorrhagic ORAL Intervention to Haematocrit Decreased Risperdal Prevent Permanent Haemoglobin Decreased (Risperidone) SS Impairment/Damage Large Intestinal Ulcer Asacol (Mesalazine) SS Nausea Prednisone Pain (Prednisone) SS Rectal Haemorrhage Solu-Medrol Rectal Ulcer (Methylprednisolone Vomiting Sodium Succinate) SS Cyclosporine SS Date:06/25/01ISR Number: 3746835-XReport Type:Expedited (15-DaCompany Report #NSADSS2001017662 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Haldol PS Rw Johnson Initial or Prolonged Malaise Health Pharmaceutical Professional Research Institute Div Ortho Pharm Risperidone SS ORAL ORAL Alosenn C Antibiotics-Resistan t Lactic Acid Bacteriae C Magnesium Oxide C Etizolam C Milnacipran C 22-Feb-2006 08:20 AM Page: 1060 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/01ISR Number: 3748212-4Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Risperdal 0.5mg PS ORAL 0.5MG HS ORAL Insomnia Weight Increased Date:06/26/01ISR Number: 3748349-XReport Type:Expedited (15-DaCompany Report #HQ2226419JUN2001 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Serax PS Faulding Other Electrocardiogram Qt Health Pharmaceutical Co ORAL ORAL/ FOR Prolonged Professional YEARS Torsade De Pointes Other Augmentin Oral Ventricular Tachycardia (Amoxicillin Trihydrate/Clavulana te Potassium) SS ORAL ORAL 7 DAY Doliprane (Paracetamol) SS ORAL ORAL Nicobion (Nicotinamide) SS ORAL ORAL Risperdal (Risperidone) SS ORAL ORAL Speciafoldine (Folic Acid) SS Vitamin B1 C Vitamin B6 C Date:06/27/01ISR Number: 3748671-7Report Type:Expedited (15-DaCompany Report #NSADSS2001018390 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn Professional Date:06/27/01ISR Number: 3748675-4Report Type:Expedited (15-DaCompany Report #NSADSS2001018388 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL 1 MG, 1 IN 1 Professional DAY (S), ORAL Date:06/27/01ISR Number: 3748718-8Report Type:Expedited (15-DaCompany Report #EMADSS2001003785 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Foreign Risperdal PS Janssen Research Fdn 1 STAT THEN 4 Initial or Prolonged Health MG DAILY Professional Clomipramine (Clomipramine) C Zolpidem (Zolpidem) C 22-Feb-2006 08:20 AM Page: 1061 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/01ISR Number: 3748720-6Report Type:Expedited (15-DaCompany Report #NSADSS2001014507 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Belligerence Foreign Risperdal PS Janssen Research Fdn ORAL 0.5 MG , 1 IN Initial or Prolonged Binocular Eye Movement Health 1 DAY(S) ORAL Disorder Professional : 1 MG , 2 IN Depressed Level Of 1 DAILY , Consciousness ORAL Hypertension Pantoprazole Hypoventilation (Pantoprazole) SS ORAL 40 MG DAILY Muscle Rigidity ORAL Inhibase (Cilazapril) SS ORAL 5 MG DAILY ORAL Paroxetine (Paroxetine) SS ORAL 30 MG DAILY ORAL Date:06/27/01ISR Number: 3748761-9Report Type:Expedited (15-DaCompany Report #EMADSS2001003256 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Risperdal PS Janssen Research Fdn THERAPY START Initial or Prolonged Health AND STOP Professional DATES Antidepressant C Date:06/27/01ISR Number: 3748762-0Report Type:Expedited (15-DaCompany Report #NSADSS2001018599 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal PS Janssen Research Fdn ORAL ORAL Health Professional Company Representative Date:06/27/01ISR Number: 3748766-8Report Type:Expedited (15-DaCompany Report #NSADSS2001018037 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Labour Foreign Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Complications Of Maternal Health Bromperidol Exposure To Therapeutic Professional (Bromperidol) SS Drugs Clotiazepan Neonatal Asphyxia (Clotiazepan) SS Trixhexyphenidyl Hydrochloride Trihexyphenidyl Hydrochloride) SS Zotepine (Zotepine) SS 22-Feb-2006 08:20 AM Page: 1062 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/01ISR Number: 3748791-7Report Type:Expedited (15-DaCompany Report #NSADSS2001014682 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Foreign Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged Dizziness Literature Biperiden Dysarthria Health Hydrochloride Dysphagia Professional (Biperiden Extrapyramidal Disorder Hydrochloride) C Gastrointestinal Motility Flunitrazepam Disorder (Flunitrazepam) C Hallucination Levothyroxine Hallucination, Auditory Sodium(Levothyroxine Psychotic Disorder Sodium) C Pyrexia Desmopressin Acetate Salivary Hypersecretion (Desmopressin Sedation Acetate) C Date:06/28/01ISR Number: 3750058-8Report Type:Expedited (15-DaCompany Report #10886844 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Buspar PS Bristol Myers Squibb Initial or Prolonged Phosphokinase Increased Health Co Pharmaceutical Bronchial Obstruction Professional Research Institute ORAL ORAL Crepitations Other Ixel (Milnacipran) SS Dehydration Athymil (Mianserin Dry Mouth Hcl) SS 30 MILLIGRAM, Dysphagia 1 DAY Extrapyramidal Disorder Risperdal Hyperhidrosis (Risperidone) SS 1 MILLIGRAM Increased Bronchial Seropram (Citalopram Secretion Hydrobromide) SS 20 MILLIGRAM, Muscle Rigidity 1 DAY Mydriasis Mepronizine(Meprobam Oxygen Saturation ate) C Decreased Atarax (Hydroxyzine Prostration Hcl) C Pyrexia Nozinan Rales (Methotrimeprazine) C Respiratory Failure Rhabdomyolysis Salivary Hypersecretion Serotonin Syndrome Tongue Disorder Tremor Date:06/29/01ISR Number: 3750252-6Report Type:Direct Company Report # Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Risperdal PS X 1 WEEK 1 WK Initial or Prolonged Muscle Spasms Tongue Disorder 22-Feb-2006 08:20 AM Page: 1063 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/01ISR Number: 3751025-0Report Type:Expedited (15-DaCompany Report #NSADSS2001019752 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL 0.5 MG, 1 IN Professional 1 NIGHT(S) ORAL Date:07/02/01ISR Number: 3751026-2Report Type:Expedited (15-DaCompany Report #NSADSS2001019402 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Risperdal PS Janssen Research Fdn ORAL 0.5 MG, 1 IN Professional 1 NIGHT(S), ORAL Date:07/02/01ISR Number: 3751255-8Report Type:Expedited (15-DaCompany Report #NSADSS2001018996 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:07/02/01ISR Number: 3751386-2Report Type:Expedited (15-DaCompany Report #NSADSS2001018998 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:07/02/01ISR Number: 3751553-8Report Type:Expedited (15-DaCompany Report #M0158-2001 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Foreign Remeron PS Organon Inc Sub Initial or Prolonged Pain In Extremity Health Akzona Inc ORAL 30-45 MG/DAY Sedation Professional PO Risperidone SS Acetylsalicylic Acid C Digitoxin C Lactulose C Reboxetin C Verapamil C Date:07/02/01ISR Number: 3751557-5Report Type:Expedited (15-DaCompany Report #NSADSS2001019421 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Risperdal PS Janssen Research Fdn ORAL 0.5 MG, 2 IN Initial or Prolonged Fracture Health 1, ORAL Other Professional 22-Feb-2006 08:20 AM Page: 1064 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/01ISR Number: 3751752-5Report Type:Expedited (15-DaCompany Report #EMADSS2001003897 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL 10 MG, DAILY, Health ORAL Professional Benzodiazepine (Benzodiazepine Derivatives) C Date:07/02/01ISR Number: 3751753-7Report Type:Expedited (15-DaCompany Report #EMADSS2001000702 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal PS Janssen Research Fdn 1.5 MG, 1 IN Hospitalization - Epilepsy Study 1 DAILY Initial or Prolonged Fall Health Depakine (Valproate Femur Fracture Professional Sodium) C Hypothermia Phenobarbital C Date:07/02/01ISR Number: 3752157-3Report Type:Expedited (15-DaCompany Report #EMADSS2001004009 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Risperdal PS Janssen Research Fdn ORAL 12 MG, DAILY, Initial or Prolonged Health ORAL Professional Depakine (Valproate Sodium) C Tavor (Lorazepam) C Dalmadorm (Flurazepam Hydrochloride) C Date:07/02/01ISR Number: 3752158-5Report Type:Expedited (15-DaCompany Report #EMADSS2001002012 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Foreign Risperdal PS Janssen Research Fdn ORAL 8 MG, DAILY, Fibrosis Health ORAL Mitral Valve Repair Professional Nozinan Pulmonary Oedema (Levomepromazine) SS ORAL 300 MG, Ventricular Hypertrophy DAILY, ORAL Depamide (Valpromide) SS ORAL 1.8 G, DAILY, ORAL Tranxene (Clorazepate Dipotassium) SS INTRAMUSCULAR 100 MG, DAILY, IM Rohypnol (Flunitrazepam) SS ORAL 1 MG, DAILY, ORAL Tercian (Cyamemazine) SS ORAL 400, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1065 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/03/01ISR Number: 3751093-6Report Type:Direct Company Report # Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Risperdal PS ORAL 1T MG ORAL 9 DAY Leukocytoclastic Vicodin C Vasculitis Atrovent C Oedema Peripheral Albuterol C Synthroid C Prilosec C Aspirin C Fluphenazine C Cogentin C Prempro C Norvasc C Flovent C Lipitor C Date:07/05/01ISR Number: 3752553-4Report Type:Direct Company Report # Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Klonopin 2mg Tid PS Initial or Prolonged Luvox SS 100MG Q1 Risperdal SS 4MG HS Zyprexia SS 20MG HS Date:07/05/01ISR Number: 3752568-6Report Type:Direct Company Report # Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Ativan PS .5MG Q 4H PRN Initial or Prolonged Confusional State Risperdal SS 0.25MG Q 4H Disorientation PRN Lethargy Imdur C Overdose Levothroid C Syncope Norvasc C Prevacid C Mom C Maalox C Tylenol C Date:07/05/01ISR Number: 3753244-6Report Type:Expedited (15-DaCompany Report #2001AP03025 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Literature Seroquel PS Astrazeneca Lp ORAL 2000 MG DAILY Intervention to Drug Level Above Health PO Prevent Permanent Therapeutic Professional Risperidone SS Impairment/Damage Electrocardiogram Qt Clonazepam SS Corrected Interval Risperidone C Prolonged Venlafaxine C Electrocardiogram Qt Topiramate C Prolonged Overdose Sedation 22-Feb-2006 08:20 AM Page: 1066 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/01ISR Number: 3753584-0Report Type:Direct Company Report # Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Disorder Risperidone 0.5mg PS ORAL 0.5MG-0.75 Initial or Prolonged DAILY ORAL Haloperidol 0.5mg SS ORAL 0.5MG-2MG DAILY ORAL Donepezil C Trazodone C Bupropion C Metoprolol C Date:07/06/01ISR Number: 3753919-9Report Type:Expedited (15-DaCompany Report #A114727 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Geodon PS Pfizer Central Initial or Prolonged Hypercapnia Professional Research ORAL 80.00 MG Thinking Abnormal Company TOTAL:BID:ORA Representative L Cogentin SS 2.00 MG TOTAL:BID Risperidone SS 3.00 MG TOTAL Depakote C Date:07/06/01ISR Number: 3753969-2Report Type:Expedited (15-DaCompany Report #NSADSS2001019158 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Risperdal PS Janssen Research Fdn ORAL 2 MG, 2 IN 1 Professional DAY (S), ORAL Ativan (Lorazepam) C Avandia (Rosiglitazone Maleate) C Procardia (Nifedipine) C Htcz (Hydrochlorothiazide ) C Clonidine C Kcl (Potassium Chloride) C Inderal (Propranolol Hydrochloride) C Humulin (Insulin) (Insulin) C Droperidol C Cogentin (Benzatropine Mesilate) C Date:07/06/01ISR Number: 3754155-2Report Type:Expedited (15-DaCompany Report #A114730 Age: Gender: I/FU:I Outcome PT Report Source Hospitalization - Aggression Health Initial or Prolonged Mania Professional 22-Feb-2006 08:20 AM Page: 1067 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Geodon PS Pfizer Central Research ORAL 80.00 MG TOTAL:BID:ORA L Cogentin SS 2.00 MG TOTAL:BID Risperidone SS 3.00 MG TOTAL Date:07/06/01ISR Number: 3754159-XReport Type:Expedited (15-DaCompany Report #A114728 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Upper Respiratory Tract Health Geodon PS Pfizer Central Initial or Prolonged Infection Professional Research ORAL 40.00 MG Viral Infection Company TOTAL:BID:ORA Representative L Risperidone SS 2.00 MG TOTAL Claritin C Iron Supplement C Date:07/09/01ISR Number: 3755467-9Report Type:Expedited (15-DaCompany Report #NSADSS2001018599 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG DAILY Health ORAL Professional Clomipramine Company (Clomipramine) C Representative Thyroxine (Levothyroxine Sodium) C Beclomethasone (Beclometasone Dipropionate) C Date:07/09/01ISR Number: 3755468-0Report Type:Expedited (15-DaCompany Report #EMADSS2001004094 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal PS Janssen Research Fdn ORAL SEE IMAGE Initial or Prolonged White Blood Cell Count Health Alprazolam Other Decreased Professional (Alprazolam) C Zopiclone (Zopiclone) C Valpromide (Valpromide) C Date:07/09/01ISR Number: 3755469-2Report Type:Expedited (15-DaCompany Report #NSADSS2001020397 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Risperdal PS Janssen Research Fdn ORAL 3 MG 1 IN 1 Health DAY(S) ORAL Professional Alprazolam 22-Feb-2006 08:20 AM Page: 1068 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Alprazolam) SS ORAL 1.2 MG 1 IN 1 DAY (S) ORAL Quazepam (Quazepam) C Magnesium Oxide (Magnesium Oxide) C Date:07/09/01ISR Number: 3755470-9Report Type:Expedited (15-DaCompany Report #EMADSS2001004085 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG/ML 2 IN Haemoglobin Decreased Health 1 DAILY ORAL Lymphocytosis Professional Neutropenia Date:07/10/01ISR Number: 3754888-8Report Type:Direct Company Report # Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Risperdal PS 3MG 2TT AS 3 YR Intervention to Depakote SS ORAL 500MG 1T BID Prevent Permanent PO 2 YR Impairment/Damage Date:07/10/01ISR Number: 3755466-7Report Type:Expedited (15-DaCompany Report #NSADSS2001018037 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Labour Foreign Risperdal PS Janssen Research Fdn INTRA-UTERINE 12 MG 1 IN 1 Initial or Prolonged Apgar Score Low Health DAY (S) Required Benign Congenital Professional UTERINE Intervention to Hypotonia Bromperidol Prevent Permanent Brain Oedema (Bromperidol) SS INTRA-UTERINE 18 MG 1 IN 1 Impairment/Damage Circulatory Failure DAY (S) Neonatal UTERINE Complications Of Maternal Clotiazepan Exposure To Therapeutic (Clotiazepam) SS INTRA-UTERINE 30 MG 1 IN 1 Drugs DAY (S) Facial Palsy UTERINE Hyperbilirubinaemia Trihexyphenidyl Neonatal Hydrochloride Laboratory Test Abnormal (Trihexyphenidyl Metabolic Acidosis Hydrochloride) SS INTRA-UTERINE 12 MG 1 IN 1 Neonatal Asphyxia DAY (S) Neonatal Disorder UTERINE) Nervous System Disorder Zotepine (Zotepine) SS INTRA-UTERINE 300 MG 1 IN 1 Subarachnoid Haemorrhage DAY (S) Neonatal UTERINE Subdural Haemorrhage Neonatal Date:07/10/01ISR Number: 3756020-3Report Type:Direct Company Report # Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Risperidone PS ORAL 1MG, 1MG HS, Initial or Prolonged ORAL 22-Feb-2006 08:20 AM Page: 1069 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/01ISR Number: 3756796-5Report Type:Expedited (15-DaCompany Report #SYMMETRL2001-00063 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Atherosclerosis Consumer Symmetrel PS Endo Pharmaceuticals Life-Threatening Blood Alkaline Inc ORAL 100 MG BID PO Hospitalization - Phosphatase Increased Risperdal SS ORAL 1.5 MG DAILY Initial or Prolonged Blood Chloride Increased PO Blood Creatinine Norvasc C Increased Prilosec C Blood Glucose Decreased Eldepryl C Blood Glucose Increased Fosamax C Blood Pressure Fluctuation Blood Sodium Decreased Blood Sodium Increased Blood Test Abnormal Blood Urea Increased Dehydration Delirium Dystonia Electrocardiogram St Segment Abnormal Electrolyte Imbalance Encephalopathy Haematocrit Decreased Haemoglobin Decreased Intercapillary Glomerulosclerosis Malnutrition Mental Disorder Mucosal Erosion Muscle Rigidity Myocardial Infarction Neuroleptic Malignant Syndrome Platelet Count Decreased Pleural Adhesion Pneumonia Pulmonary Oedema Pyrexia Red Blood Cell Count Decreased Renal Failure Respiratory Rate Increased Sedation Sepsis Speech Disorder Tachycardia Tremor Urinary Incontinence Urinary Tract Infection Ventricular Hypertrophy White Blood Cell Count Decreased White Blood Cell Count Increased 22-Feb-2006 08:20 AM Page: 1070 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/01ISR Number: 3757007-7Report Type:Expedited (15-DaCompany Report #2001012070-1 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Consumer Paxil PS Smithkline Beecham Health Pharmaceuticals ORAL ORAL Professional Risperdal (Risperidone) SS Haldol (Haloperidol) C Date:07/12/01ISR Number: 3757063-6Report Type:Direct Company Report # Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Risperdal PS ORAL 0.5MG PO QHS Eye Movement Disorder Hallucination Vision Blurred Date:07/13/01ISR Number: 3758274-6Report Type:Direct Company Report # Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Risperidone PS ORAL 0.5 MG BIORAL Required Carbamazepine C Intervention to Lorazepam C Prevent Permanent Levofloxacin C Impairment/Damage Clonazepam C Phenobarbital C Baclofen C Venlafaxine C Date:07/13/01ISR Number: 3758656-2Report Type:Expedited (15-DaCompany Report #EMADSS2001004213 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal PS Janssen Research Fdn Health Cyamemazine Professional (Cyamemazine) C Valproic Acid (Valproic Acid) C Date:07/13/01ISR Number: 3758657-4Report Type:Expedited (15-DaCompany Report #EMADSS2001004188 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Risperdal PS Janssen Research Fdn ORAL 0.5 MG , 2 IN Consciousness Health 1 DAY(S), Drug Interaction Professional ORAL : 1 Sedation MG, NIGHT(S), ORAL Erythromycin (Erythromycin) SS ORAL 500 MG , 4 IN 1 DAY(S), ORAL Paracetamol (Paracetamol) C Mst Continus 22-Feb-2006 08:20 AM Page: 1071 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Morphine Sulfate) C Dexamethasone (Dexamethasone) C Lansoprazole (Lansoprazole) C Co-Fluampicil (Magnapen) C Temazepam (Temazepam) C Date:07/13/01ISR Number: 3758658-6Report Type:Expedited (15-DaCompany Report #EMADSS2001004137 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumonia Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG , 1 IN 1 Initial or Prolonged Fall Health DAY(S) ORAL Pyrexia Professional Tercian (Cyamemazine) SS 95 DROPS DAILY Seresta (Oxazepam) SS 50 MG DAILY Aricept (Donepezil Hydrochloride) C Speciafoldine (Folic Acid) C Tardyferon (Ferrous Sulfate) C Date:07/13/01ISR Number: 3758824-XReport Type:Expedited (15-DaCompany Report #NSADSS2001021094 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL 4 MG, 1 IN 1 Professional NIGHT(S), ORAL Date:07/13/01ISR Number: 3758825-1Report Type:Expedited (15-DaCompany Report #NSADSS2001020375 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Risperdal PS Janssen Research Fdn Initial or Prolonged Professional Date:07/13/01ISR Number: 3758922-0Report Type:Expedited (15-DaCompany Report #EMADSS2001004170 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal PS Janssen Research Fdn ORAL 1 MG, DAILY, Epistaxis Health ORAL Professional Date:07/13/01ISR Number: 3758923-2Report Type:Expedited (15-DaCompany Report #EMADSS2001004238 Age:29 YR Gender:Female I/FU:I Outcome PT Other Neutrophil Count Decreased White Blood Cell Count 22-Feb-2006 08:20 AM Page: 1072 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal PS Janssen Research Fdn Health Professional Date:07/18/01ISR Number: 3760391-1Report Type:Expedited (15-DaCompany Report #262790 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Xenical PS Roche 31 DAY Initial or Prolonged Schizophrenia Teralithe C THE LONG TERM TREATMENT OF SCHIZOPHRENIA HAS BEEN LOWERED BY Zyprexa C THE LONG TERM TREATMENT OF SCHIZOPHRENIA HAS BEEN LOWERED BY Seresta C Risperdal I Date:07/20/01ISR Number: 3761971-XReport Type:Expedited (15-DaCompany Report #262790 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Xenical PS Roche 31 DAY Initial or Prolonged Schizophrenia Seresta C Risperdal I THE LONG TERM TREATMENT OF SCHIZOPHRENIA HAS BEEN LOWERED BY Teralithe I THE LONG TERM TREATMENT OF SCHIZOPHRENIA HAS BEEN LOWERED BY Date:07/20/01ISR Number: 3762533-0Report Type:Expedited (15-DaCompany Report #2013472 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Health Ms Contin PS INTRAMUSCULAR MG UNKNOWN IM Asthenia Professional Risperdal SS ORAL .5 MG TID PO Atrial Fibrillation Haldol (Haloperidol) SS INTRAMUSCULAR MG PRN IM Cardiac Failure Ciprofloxacin SS MG UNKNOWN Congestive Depakene (Valproic Cerebrovascular Accident Acid) SS Dementia Trazodone Hcl SS MG UNKNOWN Hypertension Clonidine Hcl SS TRANSDERMAL MG UNKNOWN TD Weight Decreased 22-Feb-2006 08:20 AM Page: 1073 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/20/01ISR Number: 3762535-4Report Type:Expedited (15-DaCompany Report #2013474 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Morphine Sulfate Anuria Professional (Similar To Andas Asthenia 74-769 And 74-862) PS INTRAMUSCULAR MG Q3H IM Cerebrovascular Accident Risperdal SS ORAL .5 MG TID PO Oral Intake Reduced Haldol (Haloperidol) SS INTRAMUSCULAR MG PRN IM Refusal Of Treatment By Ciprofloxacin SS MG UNKNOWN Patient Depakene (Valproic Weight Decreased Acid) SS Trazodone Hcl SS MG UNKNOWN Clonidine Hcl SS TRANSDERMAL MG UNKNOWN TD Date:07/20/01ISR Number: 3762750-XReport Type:Expedited (15-DaCompany Report #262790 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Xenical PS Hlr Technology ORAL ORAL Initial or Prolonged Drug Interaction Health Risperidal Persecutory Delusion Professional (Risperidone) SS ORAL 6 MG DAILY Schizophrenia ORAL Teralithe (Lithium Carbonate) C Zyprexa (Olanzapine) C Seresta (Oxazepam) C Date:07/20/01ISR Number: 3762825-5Report Type:Expedited (15-DaCompany Report #NSADSS2001018587 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal PS Janssen Research Fdn ORAL 2 MG, 1 IN 1 Health DAILY, ORAL Professional Lithium Carbonate (Lithium Carbonate) C Date:07/20/01ISR Number: 3762836-XReport Type:Expedited (15-DaCompany Report #EMADSS2001000217 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Risperdal PS Janssen Research Fdn ORAL 6 MG, DAILY , Initial or Prolonged Health ORAL Professional Haldol (Unspecified) (Haloperidol) SS Lepticur (Tropatepine Hydrochloride) SS ORAL 6 MG, DAILY, ORAL Theralene (Alimemazine Tartrate) SS ORAL 5 MG, DAILY, ORAL Imovane (Zopiclone) SS ORAL 0.5, DAILY, ORAL Tercian (Cyamemazine) SS ORAL 170 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1074 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/20/01ISR Number: 3762924-8Report Type:Expedited (15-DaCompany Report #NSADSS2001021289 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Post Procedural Health Risperdal PS Janssen Research Fdn Complication Professional Date:07/23/01ISR Number: 3762433-6Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Risperdal 2 Mg/ 4 Required Corrected Interval Mg Janssen PS Janssen ORAL 2MG QAM, 4MG Intervention to QHS ORAL Prevent Permanent Trazodone 50mg SS ORAL 50MG ORAL Impairment/Damage Hctz C Benazapril C Date:07/23/01ISR Number: 3763761-0Report Type:Expedited (15-DaCompany Report #NSADSS2001018471 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL MG, ORAL Health Phenothiazine Professional (Phenothiazine) SS Date:07/23/01ISR Number: 3763762-2Report Type:Expedited (15-DaCompany Report #APCDSS2001001014 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Folate Deficiency Foreign Risperdal PS Janssen Research Fdn ORAL ORAL Pancytopenia Health Vitamin B12 Decreased Professional Date:07/23/01ISR Number: 3763792-0Report Type:Expedited (15-DaCompany Report #NSADSS2001021683 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:07/23/01ISR Number: 3763866-4Report Type:Expedited (15-DaCompany Report #NSADSS2001020397 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Risperdal PS Janssen Research Fdn ORAL "SEE IMAGE" Health Alprazolam Professional (Alprazolam) SS ORAL 1.2 MG, 1 IN 1 DAY (S), ORAL Quazepam (Quazepam) C Magnesium Oxide (Magnesium Oxide) C Haldol (Tablet) (Haloperidol) C Etizolam C Trihexyphenidyl 22-Feb-2006 08:20 AM Page: 1075 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride (Trihexyphenidyl Hydrochloride) C Vegetamin A (Vegetamin A) C Levomepromazine Maleate (Levomepromazine Maleate) C Date:07/24/01ISR Number: 3764205-5Report Type:Expedited (15-DaCompany Report #S01-USA-01166-01 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Celexa PS Forest Laboratories Hospitalization - Atelectasis Professional Inc ORAL 20 MG QD PO Initial or Prolonged Blood Glucose Increased Other Risperdal Brain Oedema (Risperidone) SS Bronchopneumonia Opiods (Nos) SS Catatonia Muscle Relaxants Confusional State (Nos) SS Convulsion Levothyroxine C Depressed Level Of Consciousness Encephalopathy Hepatic Congestion Hypokalaemia Hyponatraemia Jaundice Neuroleptic Malignant Syndrome Overdose Pneumonia Aspiration Pulmonary Congestion Thrombocytopenia Thyroiditis Date:07/24/01ISR Number: 3764263-8Report Type:Expedited (15-DaCompany Report #262790 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Xenical PS Hlr Technology ORAL ORAL Initial or Prolonged Drug Interaction Health Risperdal(Risperidon Medication Error Professional e) SS ORAL 1 MG DAILY Persecutory Delusion ORAL Schizophrenia Teralithe (Lithium Carbonate) SS ORAL ORAL Seresta C Date:07/25/01ISR Number: 3765136-7Report Type:Expedited (15-DaCompany Report #NSADSS2001021958 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional 22-Feb-2006 08:20 AM Page: 1076 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/25/01ISR Number: 3765137-9Report Type:Expedited (15-DaCompany Report #NSADSS2001021823 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Risperdal PS Janssen Research Fdn ORAL 2 MG, DAILY , Hospitalization - Professional ORAL Initial or Prolonged Date:07/25/01ISR Number: 3765139-2Report Type:Expedited (15-DaCompany Report #NSADSS2001019158 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Health Risperdal PS Janssen Research Fdn ORAL 2 MG, 2 IN 1 Professional DAY (S), ORAL Ativan (Lorazepam) C Avandia (Rosiglitazone Maleate) C Procardia (Nifedipine) C Htcz (Hydrochlorothiazide ) C Clonidine (Clonidine) C Kcl (Potassium Chloride) C Inderal (Propranolol Hydrochloride) C Humulin Insulin (Insulin) C Droperidol (Droperidol) C Cogentin (Benzatropine Mesilate) C Date:07/25/01ISR Number: 3765142-2Report Type:Expedited (15-DaCompany Report #NSADSS2001017221 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal PS Janssen Research Fdn ORAL 0.5 MG, 1 IN Professional 1 NIGHT (S), ORAL Date:07/25/01ISR Number: 3765675-9Report Type:Expedited (15-DaCompany Report #NSADSS2001021988 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal PS Janssen Research Fdn ORAL ORAL Health Largactril Professional (Chlorpromazine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1077 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/25/01ISR Number: 3765676-0Report Type:Expedited (15-DaCompany Report #EMADSS2001004370 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Foreign Risperdal PS Janssen Research Fdn Health Zopiclone (Zopicone) C Professional Aricept (Donepezil Hydrochloride) C Oxybutynin (Oxybutynin) C URETHRAL Date:07/25/01ISR Number: 3765805-9Report Type:Direct Company Report # Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Risperdal PS ORAL 2 MG PO QHS Completed Suicide Insomnia Date:07/25/01ISR Number: 3765828-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Risperidone PS 1MG @HS 1.5MG Initial or Prolonged Mental Impairment @5PM Date:07/26/01ISR Number: 3766171-5Report Type:Expedited (15-DaCompany Report #PHBS2001CA06182 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Clozaril PS Novartis Neutropenia Study Pharmaceuticals Corp 550 MG/D Health Risperdal(Risperidon Professional e) SS 2 MG, QD Other Epival (Valproate Semisodium) C Haldol C Nozinan C Date:07/31/01ISR Number: 3768339-0Report Type:Direct Company Report # Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Back Pain Risperdal PS Coma Prolixin SS Headache Navane SS Intervertebral Disc Remeron SS Protrusion Ativan C Neuroleptic Malignant Syndrome Date:07/31/01ISR Number: 3768342-0Report Type:Direct Company Report # Age:24 YR Gender:Male I/FU:I Outcome PT Back Pain Neuroleptic Malignant 22-Feb-2006 08:20 AM Page: 1078 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Urine Abnormality Report Source Product Role Manufacturer Route Dose Duration Haldol One Single Dose 5mg PS ORAL 5MG PO Risperdal 2mg One @ Hs SS 1 DOSE 7/26 1 DOSE 7/27 Date:07/31/01ISR Number: 3768618-7Report Type:Expedited (15-DaCompany Report #2001UW07276 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Seroquel PS Astrazeneca Lp ORAL 600 MG DAILY Chest Pain Health PO Myocardial Infarction Professional Risperdal SS ORAL 1 MG DAILY PO Pulmonary Embolism Other Effexor SS ORAL 225 MG DAILY PO Birth Control Pills C Date:07/31/01ISR Number: 3768982-9Report Type:Expedited (15-DaCompany Report #01P-056-0108963-00 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Tranxene Sd PS Abbott Laboratories Hospitalization - Arrhythmia Health Pharmaceutical Initial or Prolonged Cardiomyopathy Professional Products Div INTRAMUSCULAR 100 MG, 1 IN Condition Aggravated Other 1 D, Delirium INTRA-MUSCULA Endocardial Fibrosis R Mitral Valve Prolapse Depamide Tablets Psychotic Disorder (Valpromide) Pulmonary Oedema (Valpromide) Sudden Death (Valpromide) SS ORAL 300 MG, 4 IN Ventricular Fibrillation 1 D, PER ORAL Ventricular Hypertrophy Levomepromazine SS ORAL 100 MG, 3 IN 1 D, PER ORAL Flunitrazepam SS ORAL 1 MG, 1 IN 1 D, PER ORAL Risperidone SS ORAL 200 MG, 1 IN 1 D, PER ORAL Risperidone SS ORAL 4 MG, 2 IN 1 D, PER ORAL Date:08/01/01ISR Number: 3768503-0Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Neurontin PS ORAL 100MG PO TID Disorientation Risperdal SS ORAL 0.5MG PO BID Dysphagia Lethargy 22-Feb-2006 08:20 AM Page: 1079 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/01ISR Number: 3769139-8Report Type:Expedited (15-DaCompany Report #NSADSS2001022652 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL 4 MG, DAILY, Professional ORAL Date:08/01/01ISR Number: 3769141-6Report Type:Expedited (15-DaCompany Report #NSADSS2001022908 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Risperdal PS Janssen Research Fdn ORAL 0.75 MG, 1 IN Professional 1 DAY, ORAL Effexor (Venlafaxine Hydrochloride) C Ambien (Zolpidem Tartrate) C Imitrex (Sumatriptan) C Zanaflex (Tizanidine Hydrochloride) C Migra (Migralgine) C Lidoderm (Lidocaine) C Gabapentin C Date:08/01/01ISR Number: 3769143-XReport Type:Expedited (15-DaCompany Report #NSADSS2001022948 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:08/01/01ISR Number: 3769175-1Report Type:Expedited (15-DaCompany Report #NSADSS2001015527 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Health Risperdal PS Janssen Research Fdn ORAL 1) 2 MG, 1 IN Required Professional 1 DAY(S), Intervention to ORAL ; 2) Prevent Permanent 1.5, DAILY, Impairment/Damage ORAL (THERAPY Date:08/01/01ISR Number: 3769177-5Report Type:Expedited (15-DaCompany Report #NSADSS2001022551 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Risperdal PS Janssen Research Fdn ORAL 2 MG, DAILY, Initial or Prolonged Anxiety Professional ORAL 1 MON Chest Pain Zoloft (Sertraline Cognitive Disorder Hydrochloride) SS ORAL 100 MG, Dyspnoea DAILY, ORAL Hallucinations, Mixed Nystagmus Palpitations Respiratory Rate Increased Serotonin Syndrome 22-Feb-2006 08:20 AM Page: 1080 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/01ISR Number: 3769179-9Report Type:Expedited (15-DaCompany Report #NSADSS2001022577 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Literature Risperdal PS Janssen Research Fdn ORAL ORAL Injury Asphyxiation Date:08/01/01ISR Number: 3769181-7Report Type:Expedited (15-DaCompany Report #NSADSS2001022903 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL Professional Date:08/01/01ISR Number: 3769184-2Report Type:Expedited (15-DaCompany Report #NSADSS2001022184 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:08/01/01ISR Number: 3769185-4Report Type:Expedited (15-DaCompany Report #NSADSS2001022182 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:08/01/01ISR Number: 3769613-4Report Type:Expedited (15-DaCompany Report #HQ3742126JUL2001 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Effexor PS Wyeth Ayerst Intraocular Pressure Professional Laboratories ORAL 75 MG 1X PER Increased 1 DAY Risperidone (Risperidone) SS ORAL Date:08/01/01ISR Number: 3769634-1Report Type:Expedited (15-DaCompany Report #EMADSS2001004486 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Risperdal PS Janssen Research Fdn ORAL 3 MG, DAILY, Health ORAL Professional Chlorthalidone (Chlortalidone) C Date:08/01/01ISR Number: 3769669-9Report Type:Expedited (15-DaCompany Report #APCDSS2001001069 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Foreign Risperdal PS Janssen Research Fdn ORAL ORAL Haemoglobin Decreased Health White Blood Cell Count Professional Decreased 22-Feb-2006 08:20 AM Page: 1081 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/01ISR Number: 3771636-6Report Type:Expedited (15-DaCompany Report #10935732 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Capozide 25/15 PS Apothecon Inc Div Hospitalization - Delirium Health Bristol Myers Squibb ORAL 1/1 DAY ORAL Initial or Prolonged Hypokalaemia Professional Tercian Loss Of Consciousness Company (Cyamemazine) SS ORAL 110 Urinary Retention Representative MILLIGRAM, Other 1/1 DAY ORAL Kerlone (Betaxolol Hcl) SS ORAL 10 MILLIGRAM, 1/1 DAY ORAL Rivotril (Clonazepam) SS ORAL 3.5 MILLIGRAM, 1/1 DAY ORAL Risperdal (Risperidone) SS ORAL 3 MILLIGRAM, 1/1 DAY ORAL Date:08/09/01ISR Number: 3774563-3Report Type:Expedited (15-DaCompany Report #A111585 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Geodon PS Pfizer Central Initial or Prolonged Dizziness Professional Research BID Drug Tolerance Decreased Risperdal SS Gastrointestinal Disorder Hallucination Paranoia Sedation Date:08/09/01ISR Number: 3775166-7Report Type:Expedited (15-DaCompany Report #NSADSS2001005434 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal PS Janssen Research Fdn ORAL 4 MG, 1 IN 1 Health DAY(S), ORAL Professional K-Dur (Potassium Chloride) C Clonazepam (Clonazepam) C Methotrimeprazine (Levomepromazine) C Lithium (Lithium) C Date:08/09/01ISR Number: 3775169-2Report Type:Expedited (15-DaCompany Report #EMADSS2001004370 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Foreign Risperdal PS Janssen Research Fdn Urinary Retention Health Zopiclone Professional (Zopiclone) C Aricept (Donepezil Hydrochloride) C Oxybutynin (Oxybutynin) C 22-Feb-2006 08:20 AM Page: 1082 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/01ISR Number: 3775170-9Report Type:Expedited (15-DaCompany Report #EMADSS2001000730 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL 1.5 MG, 2 IN Health 1 DAILY, ORAL Professional Tavor (Lorazepam) C Date:08/09/01ISR Number: 3775172-2Report Type:Expedited (15-DaCompany Report #EMADSS2001004681 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Increased Foreign Risperdal PS Janssen Research Fdn THIS DOSAGE Leukopenia Health FROM Thrombocytopenia Professional 05-JAN-01. Amoxicillin (Amoxicillin) C Valproat (Valproate Sodium) C Date:08/09/01ISR Number: 3775173-4Report Type:Expedited (15-DaCompany Report #EMADSS2001004571 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothermia Foreign Risperdal PS Janssen Research Fdn ORAL 4 MG, DAILY, Leukopenia Health ORAL Professional Haldol (Haloperidol) C Oxazepam (Oxazepam) C Date:08/09/01ISR Number: 3775235-1Report Type:Expedited (15-DaCompany Report #J081-002-000822 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Foreign Aricept PS Eisai Inc ORAL 3 MG, 1IN 1 Health D, PER ORAL Professional SEE IMAGE Impromen (Bromperidol) SS ORAL PER ORAL Risperdal (Risperidone) SS ORAL PER ORAL Akineton (Biperiden Hydrochloride) SS ORAL PER ORAL Artrane (Trihexphenidyl Hydrochloride) SS ORAL PER ORAL Benzalin (Nitrazepam) SS ORAL PER ORAL Date:08/09/01ISR Number: 3775390-3Report Type:Expedited (15-DaCompany Report #A110763 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Geodon PS Pfizer Central Initial or Prolonged Delusion Professional Research ORAL 40.00 MG Psychotic Disorder TOTAL: BID: Sedation ORAL Risperidone SS ORAL 3.00 MG TOTAL:DAILY:O 22-Feb-2006 08:20 AM Page: 1083 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report RAL Date:08/13/01ISR Number: 3775880-3Report Type:Direct Company Report # Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Risperidone(2mg) Intervention to Corrected Interval (Janssen) PS Janssen ORAL 2MG PO BID Prevent Permanent Prolonged Impairment/Damage Date:08/13/01ISR Number: 3776278-4Report Type:Expedited (15-DaCompany Report #NSADSS2001023540 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:08/13/01ISR Number: 3776556-9Report Type:Expedited (15-DaCompany Report #NSADSS2001018037 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Foreign Risperdal PS Janssen Research Fdn 12 MG, 1 IN 1 Initial or Prolonged Benign Congenital Health DAY (S), Required Hypotonia Professional UTERINE Intervention to Brain Oedema Bromperidol Prevent Permanent Circulatory Failure (Bromperidol) SS 18 MG, 1 IN 1 Impairment/Damage Neonatal DAY (S), Complications Of Maternal UTERINE Exposure To Therapeutic Clotiazepan Drugs (Clotizepam) SS 30 MG, 1 IN 1 Cyanosis Neonatal DAY (S), Facial Palsy UTERINE Feeling Cold Trihexyphenidyl Heart Disease Congenital Hydrochloride Hyperbilirubinaemia (Trihexphenidyl Neonatal Hydrochloride) SS 12 MG, 1 IN 1 Induced Labour DAY (S), Intercostal Retraction UTERINE Metabolic Acidosis Zotepine (Zotepine) SS 300 MG, 1 IN Neonatal Asphyxia 1 DAY (S), Neonatal Disorder UTERINE Prolonged Labour Pangreen-P C Shoulder Dystocia Sennoside C Subarachnoid Haemorrhage Alosenn (Alosenn) C Neonatal Senna Extract C Subdural Haemorrhage Magnesium Oxide Neonatal (Magnesium Oxide) C Tachypnoea Date:08/13/01ISR Number: 3776560-0Report Type:Expedited (15-DaCompany Report #EMADSS2001004681 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Foreign Risperdal PS Janssen Research Fdn THIS DOSAGE Hepatic Enzyme Increased Health FROM Leukopenia Professional 05-JAN-01 Thrombocytopenia Amoxicillin 22-Feb-2006 08:20 AM Page: 1084 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Amoxicillin) C Valproat (Valproate Sodium) C Date:08/13/01ISR Number: 3776566-1Report Type:Expedited (15-DaCompany Report #EMADSS2001004605 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Foreign Risperdal PS Janssen Research Fdn INTRAVENOUS 3 MG, 1 IN 1 Initial or Prolonged Medication Error Health TIME (S), IV Pyrexia Professional Date:08/16/01ISR Number: 3778437-3Report Type:Direct Company Report # Age:75 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ileus Paralytic Nortriptyline PS Risperidone SS Date:08/16/01ISR Number: 3778469-5Report Type:Direct Company Report # Age:45 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Clozaril PS Drooling Zoloft SS Gait Disturbance Risperdone SS Lethargy Serotonin Syndrome Date:08/17/01ISR Number: 3779699-9Report Type:Expedited (15-DaCompany Report #NSADSS2001021094 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Risperdal PS Janssen Research Fdn ORAL 4 MG, 1 IN 1 Professional NIGHT(S), ORAL Date:08/17/01ISR Number: 3779702-6Report Type:Expedited (15-DaCompany Report #NSADSS2001024374 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:08/17/01ISR Number: 3779705-1Report Type:Expedited (15-DaCompany Report #NSADSS2001024370 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Risperdal PS Janssen Research Fdn ORAL 0.25 MG, 2 IN Professional 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 1085 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/01ISR Number: 3779998-0Report Type:Expedited (15-DaCompany Report #NSADSS2001023936 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Risperdal PS Janssen Research Fdn ORAL ORAL Initial or Prolonged Communication Disorder Duragesic (Patch) Respiratory Arrest (Fentanyl) SS TRANSDERMAL 75 MCG/H,1 IN 72 HOUR(S), TRANSD; 50, TRANSD Oxy Ir (Oxycodone Hydrochloride) SS ORAL 5 MG, 1 IN 4 HOUR(S), ORAL Desyrel (Trazodone Hydrochloride) C Klonopin (Clonazepam) C Buspar (Buspirone Hydrochloride) C Celexa (Citalopram Hydrobromide) C Ritalin (Methylphenidate Hydrochloride) C Altase (Ramipril) C Prevacid (Lansoprazole) C Detrol (Tolterodine L-Tartrate) C Date:08/17/01ISR Number: 3779999-2Report Type:Expedited (15-DaCompany Report #NSADSS2001021683 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL 0.5 MG, 1 IN Professional 1 NIGHT(S), ORAL Neurontin (Gabapentin) C Glucophage (Metformin Hydrochloride) C Lortab (Vicodin) C Pericolace (Pericolace) C Xanax (Alprazolam) C Date:08/17/01ISR Number: 3780203-XReport Type:Expedited (15-DaCompany Report #NSADSS2001023910 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional 22-Feb-2006 08:20 AM Page: 1086 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/01ISR Number: 3780205-3Report Type:Expedited (15-DaCompany Report #NSADSS2001023904 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:08/17/01ISR Number: 3780206-5Report Type:Expedited (15-DaCompany Report #NSADSS2001023762 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL 2 MG, 1 IN 1 Professional NIGHT, ORAL Date:08/17/01ISR Number: 3780207-7Report Type:Expedited (15-DaCompany Report #NSADSS2001023898 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS Janssen Research Fdn ORAL ORAL Professional Date:08/17/01ISR Number: 3780364-2Report Type:Expedited (15-DaCompany Report #EMADSS2001003931 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Risperdal PS PATIENT Initial or Prolonged Intentional Overdose Health INGESTED 100 Required Respiratory Failure Professional TABLETS Intervention to Tercian Prevent Permanent (Cyamemazine) C DATES, DOSE Impairment/Damage AND FREQUENCY UNSPECIFIED; PATIENT INGESTED 50 Haldol Decanoas (Haloperidol Decanoate) C Tranxene (Clorazepate Dipotassium) C Loxapac (Loxapine Succinate) C Artane (Trihexyphenidyl Hydrochloride) C Forlax (Macrogol) C Gaviscon (Gaviscon /Old Form/) C Date:08/17/01ISR Number: 3780366-6Report Type:Expedited (15-DaCompany Report #EMADSS2001004773 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal PS ORAL 6 MG, DAILY, Initial or Prolonged Phosphokinase Increased Health ORAL Leukopenia Professional Tranxene Pyrexia (Clorazepate Thrombocytopenia Dipotassium) C 22-Feb-2006 08:20 AM Page: 1087 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Effexor (Venlaaxine Hydrochloride) C Date:08/17/01ISR Number: 3780370-8Report Type:Expedited (15-DaCompany Report #EMADSS2001003915 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bilirubin Conjugated Foreign Resperidone Increased Study (Unspecified) Blood Alkaline Health (Risperidone) PS DOSAGE AND Phosphatase Increased Professional THERAPY NOT Blood Chloride Increased REPORTED Blood Creatine Abnormal Chlorpromazine Blood Creatine (Chlorpromazine) C Phosphokinase Increased Extrapyramidal Disorder Liver Disorder Myocarditis Sudden Death Viral Myocarditis Date:08/17/01ISR Number: 3781235-8Report Type:Expedited (15-DaCompany Report #NSADSS2001020397 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal PS Janssen Research Fdn ORAL 3 MG, 1 IN 1 Thrombocytopenia Health DAY(S), ORAL Professional Alprazolam (Alprazolam) SS ORAL 1.2 MG, 1 IN 1 DAY(S) ORAL Quazepam (Quazepam) C Magnesium Oxide (Magnesium Oxide) C Haldol (Tablet) (Haloperidol) C Etizolam (Etizolam) C Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Vegetamin A (Vegetamin A) C Levomepromazine Maleate (Levomepromazine Maleate) C .. C Date:08/22/01ISR Number: 3782086-0Report Type:Expedited (15-DaCompany Report #APCDSS2001001133 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Risperdal (2 Mg Decreased Health Tablet) Professional (Risperidone) PS ORAL 2 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1088 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/22/01ISR Number: 3782087-2Report Type:Expedited (15-DaCompany Report #EMADSS2001004770 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risprdal (Tablet) Health (Risperidone) PS ORAL 4 MG, Professional DAILY,ORAL Date:08/23/01ISR Number: 3782450-XReport Type:Direct Company Report # Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Haloperidol Deconate Intervention to Phosphokinase Increased 100mg PS INTRAMUSCULAR 100MG Q3 Prevent Permanent Malaise WEEKS Impairment/Damage Myalgia INTRAMUSCULAR Risperdal 2mg Jannsen SS ORAL 2MG AM&HS ORAL Folic Acid C Lorazepam C Thiamine C Multi Vit C Acetaminophen C Lorazepam C Pseudodophrine C Benztropine C Buspirone C Haldol Decanoate C Lithobid C Risperdal C Date:08/23/01ISR Number: 3782570-XReport Type:Expedited (15-DaCompany Report #A108295 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Ziprasidone PS ORAL ORAL Initial or Prolonged Chest Pain Professional Risperidone SS Required Delusion Intervention to Heart Rate Increased Prevent Permanent Panic Attack Impairment/Damage Date:08/27/01ISR Number: 3783824-3Report Type:Expedited (15-DaCompany Report #2013930 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Oxyir (Oxycodone Initial or Prolonged Confusional State Other Hydrochloride) PS ORAL 5 MG Q4H PO Respiratory Depression Duragesic (Fentanyl) SS TRANSDERMAL 75 MCG Q72H TD Risperdal (Risperidone) SS ORAL PO Desyrel (Trazodone Hcl) C Klonopin (Clonazepam) C Buspar (Buspirone) C Celexa (Citalopram 22-Feb-2006 08:20 AM Page: 1089 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrobromide) C Ritalin (Methylphenidate) C Altace (Ramipril) C Prevacid (Lansoprazole) C Detrol (Tolterodine L-Tratrate) C Date:08/28/01ISR Number: 3783403-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Medication Error Risperidol Liquid Hospitalization - Unavailable PS Initial or Prolonged Date:08/28/01ISR Number: 3784043-7Report Type:Expedited (15-DaCompany Report #EMADSS2001004967 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Restlessness Foreign Risperdal (Tablet) Initial or Prolonged Rhabdomyolysis Health (Risperidone) PS ORAL 3 MG, DAILY, Professional ORAL 2 WK Diazepam (Diazepam) C Date:08/28/01ISR Number: 3784044-9Report Type:Expedited (15-DaCompany Report #EMADSS2001004974 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Risperidone Initial or Prolonged Cardiac Failure Health (Unspecified) Computerised Tomogram Professional (Risperidone) PS DOSAGE AND Abnormal THERAPY NOT Electroencephalogram REPORTED Abnormal Melleril Encephalopathy (Thioridazine Hypothermia Hydrochloride) SS UNKNOWN Nervous System Disorder Overdose Pancreatic Disorder Pyrexia Rhabdomyolysis Sedation Sinus Bradycardia Ultrasound Scan Abnormal Date:08/28/01ISR Number: 3784046-2Report Type:Expedited (15-DaCompany Report #EMADSS2001005003 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG , DAILY, ORAL Senna (Senna) C Lactulose (Lactulose) C 22-Feb-2006 08:20 AM Page: 1090 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspirin (Acetylsalicylic Acid) C Frusemide (Furosemide C Dipyridamole (Dipyridamole) C Sando-K (Sando-K) C Date:08/28/01ISR Number: 3784047-4Report Type:Expedited (15-DaCompany Report #APCDSS2001001069 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Foreign Risperdal (Talbet) Haemoglobin Decreased Health (Risperidone) PS ORAL MG, DAILY, White Blood Cell Count Professional ORAL Decreased Date:08/28/01ISR Number: 3784049-8Report Type:Expedited (15-DaCompany Report #EMADSS2001004773 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal Initial or Prolonged Phosphokinase Increased Health (Unspecified) Leukopenia Professional (Resperidone) PS 2MG FROM Pyrexia 23-JUL-01 TO Thrombocytopenia 25-JUL-01; SEE IMAGE Tranxene (Clorazepate Dipotassium) C Effexor (Venlafaxine Hydrochloride) C Tercian (Cyamemazine) C Date:08/28/01ISR Number: 3784051-6Report Type:Expedited (15-DaCompany Report #EMADSS2001004605 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Foreign Risperidone (3 Mg Initial or Prolonged Medication Error Health Talbet) Sepsis Professional (Risperidone) PS INTRAVENOUS 3 MG, 1 IN 1 TIME(S), IV; ORAL Date:08/28/01ISR Number: 3784249-7Report Type:Expedited (15-DaCompany Report #NSADSS2001025263 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Risperdal (.25 Mg Hospitalization - Pneumonia Professional Tablet) Initial or Prolonged (Risperidone) PS ORAL 0.25 MG, 1 IN 2 DAY (S),ORAL Remeron (Mirtazapine) C 22-Feb-2006 08:20 AM Page: 1091 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/01ISR Number: 3786050-7Report Type:Expedited (15-DaCompany Report #01-1263 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Loxitane (Loxapac) Initial or Prolonged Phosphokinase Increased Health Capsules Formulation Other Blood Creatine Professional Unknown, Phosphokinase Mb Company Wyeth-Ayerst, 5 Days PS Wyeth-Ayerst ORAL ORAL Increased Representative Loxitane (Loxapac) Blood Lactate Caps Formulation Dehydrogenase Increased Unk, Wyeth-Ayerst, 3 Disturbance In Attention Dy SS ORAL ORAL Hallucination Risperdal Musculoskeletal Stiffness (Risperidone) Pyrexia Unknown, Unknown, 57 Skin Disorder Days SS ORAL ORAL Tachycardia Topalgic "Houde" (Tramadol Hydrochloride) C Depamide (Valpromide) C Myolastan (Tetrazepam) C Floxyfral (Fluvoxamine Maleate) C Cozaar (Losartan Potassium) C Date:08/31/01ISR Number: 3786745-5Report Type:Expedited (15-DaCompany Report #NSADSS2001020017 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal (1 Mg Initial or Prolonged Health Taablet) Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Isoprenaline Hydrochloride (Isoprenaline Hydrochloride) C Haldol (Haloperidol) C Date:08/31/01ISR Number: 3786749-2Report Type:Expedited (15-DaCompany Report #EMADSS2001005073 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Corticotrophin Foreign Risperdal (Tablet) Initial or Prolonged Decreased Health (Risperidone) PS ORAL 2 MG, DAILY, Blood Prolactin Increased Professional ORAL Blood Thyroid Stimulating Hormone Decreased 22-Feb-2006 08:20 AM Page: 1092 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3787014-XReport Type:Expedited (15-DaCompany Report #NSADSS2001022903 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS ORAL ORAL Professional Date:08/31/01ISR Number: 3787100-4Report Type:Periodic Company Report #A114798 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Ziprasidone Po PS ORAL 20.00 MG Congenital Central TOTAL:DAILY:O Nervous System Anomaly RAL Drug Ineffective Risperidone SS Muscle Twitching Luvox C Sedation Weight Decreased Date:08/31/01ISR Number: 3787104-1Report Type:Periodic Company Report #A114907 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Ziprasidone Po PS 80.00 MG Confusional State Professional TOTAL:BD Insomnia Atropine SS Risperidone SS Clozaril C Cogentin C Date:08/31/01ISR Number: 3787166-1Report Type:Periodic Company Report #A117100 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Urinary Retention Health Ziprasidone Po PS Professional Cogentin SS Risperdal SS Effexor C Dalmane C Alleve C Date:08/31/01ISR Number: 3787595-6Report Type:Periodic Company Report #A112523 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Ziprasidone PS BID Bronchitis Professional Risperdal SS 1.00 MG Malaise TOTAL:DAILY Respiratory Tract Depakote C Infection Neurontin C Weight Increased Remeron C Klonopin C 22-Feb-2006 08:20 AM Page: 1093 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/01ISR Number: 3788333-3Report Type:Periodic Company Report #A109262 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nausea Health Ziprasidone Po PS ORAL 20.00 MG Vomiting Professional TOTAL:BID:ORA L Lithium Carbonate SS ORAL 1200.00 MG TOTAL:DAILY:O RAL Risperdal SS ORAL 4.00 MG TOTAL:BID:ORA L Date:09/03/01ISR Number: 3787562-2Report Type:Expedited (15-DaCompany Report #EMADSS2001005112 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Risperdal (2 Mg Initial or Prolonged Inappropriate Health Tablet) Antidiuretic Hormone Professional (Risperidone) PS UNKNOWN 2 MG, DAILY Secretion Intentional Overdose Metabolic Acidosis Suicide Attempt Date:09/03/01ISR Number: 3787563-4Report Type:Expedited (15-DaCompany Report #EMADSS2001005113 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Foreign Risperdal Required Complications Of Maternal Health (Unspecified ) Intervention to Exposure To Therapeutic Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 Prevent Permanent Drugs DAILY, ORAL Impairment/Damage Intra-Uterine Death Rivotril Pregnancy (Clonazepam) C Date:09/03/01ISR Number: 3787565-8Report Type:Expedited (15-DaCompany Report #NSADSS2001025814 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Foreign Risperdal (2 Mg Fall Health Tablet) Hyperaesthesia Professional (Risperidone) PS ORAL 2 MG, DAILY, Muscle Spasms ORAL Duragesic (Patch) (Fentanyl) SS TRANSDERMAL 325 MCG/H, TRANSD; 325 MCG/H, TRANSD Morphine (Morphine) C Maxeran (Metoclopramide Hydrochloride) C Tylenol L(Paracetamol) C Gravol (Dimenhydrinate) C Imovane (Zopiclone) C 22-Feb-2006 08:20 AM Page: 1094 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/04/01ISR Number: 3786927-2Report Type:Direct Company Report # Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Risperdal PS ORAL 1 MG PO BID, Intervention to Musculoskeletal Stiffness DOSE Prevent Permanent Speech Disorder INCREASED Impairment/Damage Tongue Oedema Celexa C Lithium C Date:09/04/01ISR Number: 3786940-5Report Type:Direct Company Report # Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Clomipramine PS ORAL 100 MG QD PO Initial or Prolonged Urinary Tract Infection Risperidal SS ORAL 1MG QD PO Required Intervention to Prevent Permanent Impairment/Damage Date:09/04/01ISR Number: 3787794-3Report Type:Expedited (15-DaCompany Report #NSADSS2001022948 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Chronic Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:09/04/01ISR Number: 3787869-9Report Type:Expedited (15-DaCompany Report #NSADSS2001023540 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 3 MG, 2 IN DAILY, ORAL Date:09/06/01ISR Number: 3788932-9Report Type:Expedited (15-DaCompany Report #NSADSS2001026589 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS Janssen ORAL ORAL Date:09/06/01ISR Number: 3788935-4Report Type:Expedited (15-DaCompany Report #NSADSS2001026604 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS Janssen ORAL ORAL 22-Feb-2006 08:20 AM Page: 1095 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/01ISR Number: 3788999-8Report Type:Expedited (15-DaCompany Report #NSADSS2001026590 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:09/06/01ISR Number: 3789194-9Report Type:Expedited (15-DaCompany Report #EMADSS2001005183 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sideroblastic Anaemia Foreign Risperidone PS DOSAGE AND Health THERAPY NOT Professional REPORTED Date:09/06/01ISR Number: 3789195-0Report Type:Expedited (15-DaCompany Report #EMADSS2001005150 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Disorder Foreign Risperdal PS 4 MG, 1 IN 1 Thrombocytopenia Health DAILY, Professional UNKNOWN 10 MON Date:09/06/01ISR Number: 3789216-5Report Type:Expedited (15-DaCompany Report #2001070691FR Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Aldactone Initial or Prolonged Pancytopenia Health (Spironolactone) Professional Tablet PS ORAL 25 MG/DAY, Other ORAL Mirtazapine "Organon" (Mirtazapine) SS Organon ORAL 30 MG/DAY, ORAL Depamide (Valpromide) SS ORAL 1500 MG/DAY, ORAL Lasilix (Furosemide) SS ORAL 40 MG/DAY , ORAL Coversyl (Perindopril) SS ORAL 2 DF, ORAL Risperdal (Risperidone) SS ORAL 8 MG/DAY, ORAL Noctran 10 (Acepromazine, Acepromazine) C Nitriderm Tts C Lepticur (Tropatepine Hydrochloride) C Mepronizine (Aceprometazine, Meprobamate) C Tranxene C 22-Feb-2006 08:20 AM Page: 1096 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/01ISR Number: 3789240-2Report Type:Expedited (15-DaCompany Report #APCDSS2001001133 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal (2 Mg Health Tablet) Professional (Risperidone) PS ORAL 2 MG, DAILY, ORAL Date:09/06/01ISR Number: 3789427-9Report Type:Expedited (15-DaCompany Report #NSADSS2001022908 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 0.75 MG, 1 IN 1 DAY, ORAL Effexor (Venlafaxine Hydrochloride) C Ambien (Zolpidem Tartrate) C Imitrex (Sumatriptan) C Zanaflex (Tizanidine Hydrochloride) C Migra (Migralgine) C Lidoderm (Lidocaine) C Gabapentin C Date:09/07/01ISR Number: 3788897-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Risperdal PS Jannsen ORAL 2 MG, 1 MG, Intervention to Corrected Interval 6M/AM, Prevent Permanent Prolonged 2PM/ORAL Impairment/Damage Date:09/07/01ISR Number: 3789644-8Report Type:Expedited (15-DaCompany Report #A120625 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Foreign Atarax Tablets PS 75.00 MG Intervention to Drug Interaction Other TOTAL:TID Prevent Permanent Muscle Rigidity Venlafaxine SS ORAL 75.00 MG Impairment/Damage Pain TOTAL:DAILY:O RAL Risperidone SS ORAL 1.00 MG TOTAL:DAILY:O RAL Date:09/07/01ISR Number: 3790090-1Report Type:Expedited (15-DaCompany Report #EMADSS2001005021 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperidone Study (Unspecified) Health (Risperidone) PS ORAL 2 MG, DAILY, Professional ORAL 22-Feb-2006 08:20 AM Page: 1097 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/12/01ISR Number: 3792315-5Report Type:Expedited (15-DaCompany Report #A120871 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Consumer Zoloft Tablets PS TRANSPLACENTAL 300.00 MG Initial or Prolonged Complications Of Maternal TOTAL DAILY Required Exposure To Therapeutic Risperdal SS TRANSPLACENTAL Intervention to Drugs Prevent Permanent Developmental Delay Impairment/Damage Neonatal Apnoeic Attack Neonatal Disorder Thyroid Disorder Tremor Neonatal Date:09/12/01ISR Number: 3792761-XReport Type:Expedited (15-DaCompany Report #EMADSS2001005232 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Risperdal(Unspecifie Decreased Health d) (Risperidone) PS DOSAGE Professional REDUCED TO 3.5 MG FOLLOWING THE EVENT Date:09/12/01ISR Number: 3792764-5Report Type:Expedited (15-DaCompany Report #EMADSS2001004900 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Risperdal(Unspecifie Initial or Prolonged Aminotransferase Health d) (Risperidone) PS SEE IMAGE Other Increased Professional Flucloxacillin Blood Creatine (Flucloxacillin) C Phosphokinase Increased Fluoxetine Ecchymosis (Fluoxetine) C Fall Muscle Injury Muscle Rigidity Date:09/12/01ISR Number: 3792767-0Report Type:Expedited (15-DaCompany Report #NSADSS2001018037 Age:0 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abnormal Labour Initial or Prolonged Benign Congenital Required Hypotonia Intervention to Brain Oedema Prevent Permanent Complications Of Maternal Impairment/Damage Exposure To Therapeutic Drugs Congenital Cardiovascular Anomaly Cyanosis Enzyme Abnormality Facial Palsy Feeling Cold Hyperbilirubinaemia Induced Labour Intercostal Retraction 22-Feb-2006 08:20 AM Page: 1098 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metabolic Acidosis Movement Disorder Neonatal Asphyxia Report Source Product Role Manufacturer Route Dose Duration Neonatal Disorder Foreign Risperidone(Tablet) Premature Rupture Of Health (Risperidone) PS 12 MG , 1 IN Membranes Professional 1 DAY(S), Prolonged Labour UTERINE Shock Bromperidol(Bromperi Shoulder Dystocia dol) SS 18 MG, 1 IN 1 Subarachnoid Haemorrhage DAY(S), Subdural Haematoma UTERINE Tachypnoea Clotiazepam(Clotiaze pam) SS 30 MG, 1 IN 1 DAY(S), UTERINE Trihexyphenidyl Hydrochloride(Trihex yphenidyl Hydrochloride) SS 12 MG, 1 IN 1 DAY(S), UTERINE Zotepine(Zotepine) SS 300 MG, 1 IN 1 DAY(S), UTERINE Pangreen-P C Sennoside C Alosenn (Alosenn) C Senna Extract C Magnesium Oxide C Date:09/12/01ISR Number: 3792805-5Report Type:Expedited (15-DaCompany Report #EMADSS2001005183 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Foreign Risperidone Health (Unspecified) PS Professional Date:09/12/01ISR Number: 3792808-0Report Type:Expedited (15-DaCompany Report #EMADSS2001004094 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Risperidone PS ORAL SEE IMAGE Initial or Prolonged Neutropenia Health Alprazolam C Professional Zopiclone C Valpromide C Date:09/12/01ISR Number: 3792810-9Report Type:Expedited (15-DaCompany Report #EMADSS2001005264 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Foreign Risperidone (Tablet) PS ORAL 8 MG, DAILY, Initial or Prolonged Medication Error Health ORAL Professional 22-Feb-2006 08:20 AM Page: 1099 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/13/01ISR Number: 3792770-0Report Type:Expedited (15-DaCompany Report #PERI00201003801 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Coversyyl Initial or Prolonged Health (Perindopril) PS ORAL 2 DF QD PO Professional Risperdal Other (Risperidone) SS ORAL 8 MG QD PO Depamide (Valpromide) SS ORAL 1500 MG QD PO Mirtazapine SS ORAL 30 MG QD PO Aldactone (Spironolactone) SS ORAL 15 MG QD PO Lasilix (Furosemide)` SS ORAL 40 MG QD PO Date:09/13/01ISR Number: 3796483-0Report Type:Direct Company Report #54392 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Risperdal(Risperidon e) PS Janssen Date:09/14/01ISR Number: 3793249-2Report Type:Direct Company Report # Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Muscle Twitching Risperdal PS ORAL 2MG PO HS Intervention to Prevent Permanent Impairment/Damage Date:09/14/01ISR Number: 3793605-2Report Type:Expedited (15-DaCompany Report #NSADSS2001026867 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:09/14/01ISR Number: 3793606-4Report Type:Expedited (15-DaCompany Report #NSADSS2001026629 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Tablet) (Risperidone) PS ORAL ORAL Date:09/14/01ISR Number: 3793865-8Report Type:Expedited (15-DaCompany Report #PHBS2001CH08915 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Foreign Clozaril Drug Interaction Health (Clozapine)Tablet PS ORAL 100 MG/D, Obsessive-Compulsive Professional ORAL Disorder Other Risperdal (Risperidone) SS ORAL 8 MG/D, ORAL 22-Feb-2006 08:20 AM Page: 1100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/14/01ISR Number: 3794236-0Report Type:Expedited (15-DaCompany Report #NSADSS2001026860 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:09/14/01ISR Number: 3794257-8Report Type:Expedited (15-DaCompany Report #EMADSS2001005221 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytoclastic Foreign Risperdal (Solution) Vasculitis Health (Risperidone) PS ORAL ORAL Professional Triatec (Ramipril) C Kardegic (Acetylsalicylate Lysine) C Temesta (Lorazepam) C Iskedyl (Iskedyl) C Date:09/14/01ISR Number: 3794270-0Report Type:Expedited (15-DaCompany Report #2001AP02857 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Foreign Seroquel "Zeneca" PS Zeneca Intervention to Aggression Other Risperidone SS Prevent Permanent Murder Paxil C Impairment/Damage Speech Disorder Evamyl C Toxicologic Test Abnormal Date:09/17/01ISR Number: 3793878-6Report Type:Direct Company Report # Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Fall Risperidone PS ORAL 0.5 MG/ QHS/ Hospitalization - Hip Fracture ORAL Initial or Prolonged Orthostatic Hypotension Prazosin/ 2 Mg SS ORAL 2 MG/ QHS/ Required ORAL Intervention to Prazosin C Prevent Permanent Resperidol C Impairment/Damage Mvi C Vit E C Ketoconazole C Ginko C Trazodone C Date:09/17/01ISR Number: 3794927-1Report Type:Expedited (15-DaCompany Report #J081-002-000822 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Foreign Aricept (Donepezil) PS ORAL 3 MG, 1 IN 1 Health D PER ORAL; 5 Professional MG, 1 IN 1 D, PER ORAL Impromen (Bromperidol) SS ORAL UNREPORTED, PER ORAL 22-Feb-2006 08:20 AM Page: 1101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal (Risperidone) SS ORAL UNREPORTED, PER ORAL Akineton (Biperiden Hydrochloride) SS ORAL UNREPORTED, PER ORAL Artane (Trihexyphenidyl Hydrochloride) SS ORAL UNREPORTED, PER ORAL Benzalin (Nitrazepam) SS ORAL UNREPORTED, PER ORAL Date:09/19/01ISR Number: 3795776-0Report Type:Expedited (15-DaCompany Report #2001070691FR Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Aldactone Initial or Prolonged Pancytopenia Health (Spironolactone) Professional Tablet PS ORAL 25 MG/DAY, Other ORAL Mirtazapine "Organon" (Mirtazapine) SS ORAL 30 MG/DAY, ORAL Depamide (Valpromide) SS ORAL 1500 MG/DAY, ORAL Mepronizine (Aceprometazine, Meprobamate) SS Risperdal (Risperidone) SS ORAL 8 MG/DAY, ORAL Lasilix C Clomipramine C Tranxene C Coversyl (Perindopril) C Noctran 10 (Acepromazine, Aceprometazine) C Nitriderm Tts C Lepticur (Tropatepine Hydrochloride) C Date:09/19/01ISR Number: 3795811-XReport Type:Expedited (15-DaCompany Report #EMADSS2001005073 Age:63 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Corticotrophin Initial or Prolonged Decreased Blood Growth Hormone Increased Blood Thyroid Stimulating Hormone Decreased Diabetes Insipidus 22-Feb-2006 08:20 AM Page: 1102 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperprolactinaemia Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal (Tablet) Health (Risperidone) PS ORAL 2 MG DAILY Professional ORAL Date:09/19/01ISR Number: 3796095-9Report Type:Expedited (15-DaCompany Report #APCDSS2001001233 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Female Foreign Risperdal Initial or Prolonged Consumer (Risperidone) PS ORAL MG, ORAL Required Intervention to Prevent Permanent Impairment/Damage Date:09/19/01ISR Number: 3796103-5Report Type:Expedited (15-DaCompany Report #NSADSS2001027862 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:09/19/01ISR Number: 3796105-9Report Type:Expedited (15-DaCompany Report #NSADSS2001027513 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:09/19/01ISR Number: 3796107-2Report Type:Expedited (15-DaCompany Report #NSADSS2001022184 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcoholism Health Risperdal Hepatic Encephalopathy Professional (Risperidone) PS ORAL ORAL Liver Disorder Date:09/19/01ISR Number: 3796152-7Report Type:Expedited (15-DaCompany Report #NSADSS2001027374 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 1103 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/19/01ISR Number: 3796154-0Report Type:Expedited (15-DaCompany Report #NSADSS2001027377 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:09/19/01ISR Number: 3796190-4Report Type:Expedited (15-DaCompany Report #NSADSS2001027101 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:09/19/01ISR Number: 3796211-9Report Type:Expedited (15-DaCompany Report #APCDSS2001001230 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperidone Initial or Prolonged Malaise Health (Risperidone) PS ORAL 1 MG, 1 IN 1 Parkinsonism Professional DAILY, ORAL;SEE IMAGE Date:09/19/01ISR Number: 3796222-3Report Type:Expedited (15-DaCompany Report #EMADSS2001005113 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Risperdal Required Exposure To Therapeutic Health (Unspecified) Intervention to Drugs Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 Prevent Permanent Intra-Uterine Death DAILY, ORAL Impairment/Damage Pregnancy Rivotril (Clonazepam) C Date:09/19/01ISR Number: 3796332-0Report Type:Expedited (15-DaCompany Report #EMADSS2001005212 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Risperidone (Tablet) Initial or Prolonged Hyponatraemia Health (Risperidone) PS ORAL 2 MG, 1 IN 1 Polydipsia Professional DAILY, ORAL Company Tercian Representative (Cyamemazine) C Temesta (Lorazepam) C Stablon (Tianeptine) C Normison (Temazepam) C Forlax (Macrogol) C Date:09/19/01ISR Number: 3796333-2Report Type:Expedited (15-DaCompany Report #EMADSS2001005392 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Life-Threatening Hypernatraemia Foreign Health 22-Feb-2006 08:20 AM Page: 1104 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal (Unspecified) (Risperidone) PS ORAL 2 MG, DAILY, ORAL Lithium (Lithium) SS Perphenan (Perphenazine) C Date:09/19/01ISR Number: 3796334-4Report Type:Expedited (15-DaCompany Report #EMADSS2001005480 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Foreign Risperidone Health (Unspecified) Professional (Risperidone) PS Metformin (Metformin) C Fluoxetine (Fluoxetine) C Gliclazide (Gliclazide) C Date:09/19/01ISR Number: 3796335-6Report Type:Expedited (15-DaCompany Report #APCDSS2001001227 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Adams-Stokes Syndrome Foreign Risperidone Loss Of Consciousness Health (Unspecified) Professional (Risperidone) PS ORAL SEE IMAGE Date:09/19/01ISR Number: 3796338-1Report Type:Expedited (15-DaCompany Report #APCDSS2001001229 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adams-Stokes Syndrome Foreign Risperidone Initial or Prolonged Blood Pressure Decreased Health (Unspecified) Professional (Risperidone) PS ORAL SEE IMAGE Date:09/20/01ISR Number: 3796398-8Report Type:Expedited (15-DaCompany Report #2001AP02857 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Murder Foreign Seroquel "Zeneca" PS "Zeneca" Intervention to Health Risperidone SS Prevent Permanent Professional Paxil C Impairment/Damage Other Evamyl C Date:09/21/01ISR Number: 3797352-2Report Type:Expedited (15-DaCompany Report #EMADSS2001004900 Age:67 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 1105 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Aspartate Foreign Risperdal Aminotransferase Health (Unspecified) Increased Professional (Risperidone) PS INCRASED FROM Ecchymosis 3 MG TO 6 MG Fall (AS NO Muscle Injury RESPONSE ON Muscle Rigidity 3MG) Fluoxetine (Fluoxetine) C Date:09/21/01ISR Number: 3797353-4Report Type:Expedited (15-DaCompany Report #NSADSS2001020017 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal (1 Mg Initial or Prolonged Health Tablet) Professional (Risperidone) PS ORAL 1; 0.5 MG DAILY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Haldol (Haloperidol) C Date:09/21/01ISR Number: 3797403-5Report Type:Expedited (15-DaCompany Report #NSADSS2001028066 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS ORAL ORAL Professional Date:09/21/01ISR Number: 3797611-3Report Type:Expedited (15-DaCompany Report #EMADSS2001004141 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Biliary Neoplasm Foreign Risperdal (1 Mg Initial or Prolonged Gamma-Glutamyltransferase Health Tablet) Other Increased Professional (Risperidone) PS Janssen Research Jaundice Foundation ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Zoltum (Omeprazole) C Omix (Tamsulosin Hydrochloride) C Seresta (Oxazepam) C Seresta (Oxazepam) C Lysanxia C Date:09/21/01ISR Number: 3797613-7Report Type:Expedited (15-DaCompany Report #EMADSS2001005476 Age: Gender:Female I/FU:I Outcome PT Report Source Other Petit Mal Epilepsy Foreign Health 22-Feb-2006 08:20 AM Page: 1106 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal (Unspecified) (Risperidone) PS Janssen Research Foundation Depo-Provera (Medroxyprogesterone Acetate) C Date:09/21/01ISR Number: 3797614-9Report Type:Expedited (15-DaCompany Report #EMADSS2001005514 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Foreign Risperidone (2 Mg Required Syndrome Health Tablet) PS Janssen Research Intervention to Professional Foundation, Usa ORAL 2 MG, 3 IN 1 Prevent Permanent DAY(S), ORAL Impairment/Damage Thioridazine SS ORAL 100 MG, 1 IN 1 DAY(S) ORAL Biperiden C Carbamazepine C Diazepam C Date:09/21/01ISR Number: 3797640-XReport Type:Expedited (15-DaCompany Report #EMADSS2001004238 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperidone Health (Unspecified) Professional (Risperidone) PS DATES UNSPECIFIED Date:09/21/01ISR Number: 3797685-XReport Type:Expedited (15-DaCompany Report #EMADSS2001005529 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal ( Health Unspecified) Professional (Risperidone) PS ORAL 6 MG, DAILY, ORAL Date:09/21/01ISR Number: 3797687-3Report Type:Expedited (15-DaCompany Report #EMADSS2001005537 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention-Seeking Foreign Risperidone (Tablet) Initial or Prolonged Behaviour Health (Risperidone) PS ON 11-JUN-01 Hypoaesthesia Professional PATIENT Sedation INGESTED 3X 1 MG TABLETS 22-Feb-2006 08:20 AM Page: 1107 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/01ISR Number: 3797689-7Report Type:Expedited (15-DaCompany Report #EMADSS2001005608 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancytopenia Foreign Risperdal (3 Mg Pneumonia Health Tablet) Professional (Risperidone) PS 3 MG, 2 IN 1 DAY (S), UNKNOWN Tremblex (Dexetimde) C Date:09/21/01ISR Number: 3797690-3Report Type:Expedited (15-DaCompany Report #APCDSS2001001227 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adams-Stokes Syndrome Foreign Risperidone Initial or Prolonged Condition Aggravated Health (Unspecified)(Risper Loss Of Consciousness Professional idone) PS ORAL SEE IMAGE Sinus Bradycardia Biperiden Supraventricular Hydrochloride Extrasystoles (Biperiden Hydrochloride) C Propericiazine C Triazolam (Triazolam) C Date:09/21/01ISR Number: 3797692-7Report Type:Expedited (15-DaCompany Report #APCDSS2001001229 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adams-Stokes Syndrome Foreign Risperdal (Tablet) Initial or Prolonged Bradycardia Health (Risperidone) PS ORAL SEE IMAGE Professional Haldol (Tablet) (Haloperidol) C Levomepromazine Maleate (Levomepromazine Maleate) C Timiperone (Timiperone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:09/21/01ISR Number: 3797694-0Report Type:Expedited (15-DaCompany Report #EMADSS2001004770 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal (Tablet) Health (Rispridone) PS ORAL SEE IMAGE Professional 22-Feb-2006 08:20 AM Page: 1108 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/01ISR Number: 3797696-4Report Type:Expedited (15-DaCompany Report #EMADSS2001005380 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Risperdal (4 Mg Initial or Prolonged Health Tablet) Other Professional (Risperidone) PS ORAL 4 MG, 2 IN 1 DAY(S), ORAL Norset (Mirtazapine) SS ORAL 30 MG, DAILY, ORAL Aldactone (Spironolactone) SS ORAL 25 MG, DAILY, ORAL Depamide (Valpromide) SS ORAL 1500 MG, DAILY, ORAL Lasilix (Furosemide) C Coversyl (Perindopril) C Nitriderm (Glyceryl Trinitrate) C Tranxene (Clorazepate Dipotassium) C Mepronizine (Mepronizine) C Lepticur Tropatepine Hydrochloride) C Date:09/24/01ISR Number: 3797775-1Report Type:Direct Company Report # Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Platelet Count Decreased Risperidone PS ORAL 0.5MG/QD/ORAL Intervention to Folic Acid C Prevent Permanent Lorazepam Taper C Impairment/Damage Sertraline C Sertraline C Thiamine C Mvi C Date:09/25/01ISR Number: 3798309-8Report Type:Direct Company Report # Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Thorazine PS 50MG X 4 Initial or Prolonged Syndrome DOSES FOR 3 CONSECUTIVE DAYS Risperidone SS 1.5 MG BID Clonidine C Date:09/26/01ISR Number: 3798862-4Report Type:Direct Company Report # Age:44 YR Gender:Male I/FU:I Outcome PT Life-Threatening Blood Creatine Phosphokinase Increased Loss Of Consciousness 22-Feb-2006 08:20 AM Page: 1109 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Rigidity Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Tachycardia Geodon (Ziprasidone) PS 20MG BID Tremor Risperidone SS 2 MG BID Diabeta C Motrin C Glucophage C Paxil C Atarax C Klonopin C Date:09/26/01ISR Number: 3799920-0Report Type:Direct Company Report # Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Risperidone (3mg) PS ORAL 3MG PO BID Multivitamins C Feso4 C Fluoxetine C Benztropine C Didanosine C Stavudine C Lorazepam C Date:09/26/01ISR Number: 3800280-7Report Type:Direct Company Report # Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Risperdal PS Janssen ORAL 0.25/0.5/ Initial or Prolonged Abnormal Faeces QAM/QPM/ ORAL Dystonia Diphenhydramine C Hypertension Date:09/27/01ISR Number: 3801649-7Report Type:Expedited (15-DaCompany Report #EMADSS2001005221 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytoclastic Foreign Risperdal (Solution) Vasculitis Health (Risperidone) PS Professional Triatec (Ramipril) SS Kardegic (Acetylsalicylate Lysine) C Temesta (Lorazepam) C Iskedyl (Iskedyl) C Date:09/27/01ISR Number: 3801768-5Report Type:Direct Company Report # Age:3 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lethargy Risperdal Oral Sln Initial or Prolonged Medication Error 1mg/Ml Janssen Pharm PS Janssen Pharm ORAL 2.5 MG PO QHS Adderrall C Depakote C 22-Feb-2006 08:20 AM Page: 1110 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/01ISR Number: 3802080-0Report Type:Expedited (15-DaCompany Report #NSADSS2001029321 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, 2 IN DAILY, ORAL Date:09/28/01ISR Number: 3802250-1Report Type:Expedited (15-DaCompany Report #EMADSS2001005212 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Risperidone (Tablet) Initial or Prolonged Hyponatraemia Health (Risperidone) PS ORAL 2 MG, 1 IN 1 Polydipsia Professional DAILY, ORAL Company Tercian Representative (Cyamemazine) C Temesta (Lorazepam) C Stablon (Tianeptine) C Normison (Temazepam) C Forlax (Macrogol) C Date:10/01/01ISR Number: 3802808-XReport Type:Expedited (15-DaCompany Report #2001UW12078 Age:57 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Foreign Seroquel "Zeneca" PS Other Risperdal SS Date:10/02/01ISR Number: 3803581-1Report Type:Expedited (15-DaCompany Report #HQ6240621SEP2001 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Condition Aggravated Health Temesta (Lorazepam, Dental Caries Professional Tablet) PS ORAL 1-3 MG DAILY Tooth Disorder Other Melleretten (Thioridazine Hydrochloride) SS ORAL 5-25 MG DAILY Remeron (Mirtazapine) SS ORAL 60 MG 1X PER 1 DAY Risperdal (Risperidone) SS ORAL 1 MG 1X PER 1 DAY 2 WK Date:10/02/01ISR Number: 3803900-6Report Type:Expedited (15-DaCompany Report #EMADSS2001005676 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chronic Obstructive Foreign Risperdal (0.5 Mg Pulmonary Disease Health Tablet) Torsade De Pointes Professional (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAY(S), ORAL Frumil (Frumil) C Metoprolol (Metoprolol) C 22-Feb-2006 08:20 AM Page: 1111 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Citalopram (Citalopram) C Date:10/02/01ISR Number: 3803908-0Report Type:Expedited (15-DaCompany Report #NSADSS2001029142 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified)(Risper idone) PS ORAL ORAL Date:10/02/01ISR Number: 3803945-6Report Type:Expedited (15-DaCompany Report #NSADSS2001023898 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Risperdal Congestive Professional (Unspecified) Escherichia Sepsis (Risperidone) PS ORAL ORAL Pneumonia Date:10/02/01ISR Number: 3804078-5Report Type:Expedited (15-DaCompany Report #EMADSS2001005212 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Risperidone (Tablet) Initial or Prolonged Hyponatraemia Health (Risperidone) PS ORAL 2 MG, 1 IN 1 Polydipsia Professional DAILY, ORAL Company Tercian Representative (Cyamemazine) C Temesta (Lorazepam) C Stablon (Tianeptine) C Normison (Temazepam) C Forlax (Macrogol) C Date:10/02/01ISR Number: 3804079-7Report Type:Expedited (15-DaCompany Report #EMADSS2001005609 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Hospitalization - Suicide Attempt Health (Unspecified) Initial or Prolonged Professional (Risperidone) PS Cipramil (Citalopram) C Date:10/02/01ISR Number: 3804080-3Report Type:Expedited (15-DaCompany Report #EMADSS2001005539 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Risperidone Initial or Prolonged Circulatory Collapse Health (Unspecified) Hyponatraemia Professional (Risperidone) PS ORAL 2 MG, DAILY, Urinary Incontinence ORAL Thyroxin (Levothyroxine Sodium) C 22-Feb-2006 08:20 AM Page: 1112 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/01ISR Number: 3804193-6Report Type:Expedited (15-DaCompany Report #NSADSS2001029631 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Left Ventricular Failure Health Risperdal(.25 Mg Professional Tablet)(Risperidone) PS ORAL ORAL Company Representative Date:10/02/01ISR Number: 3804194-8Report Type:Expedited (15-DaCompany Report #NSADSS2001026496 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Risperdal(Tablet)(Ri Convulsion Professional speridone) PS ORAL ORAL Difficulty In Walking Dilantin (Phenytoin Nystagmus Sodium) SS ORAL ORAL Paraesthesia Xanax (Alprazolam) C Visual Disturbance Weight Decreased Date:10/02/01ISR Number: 3804210-3Report Type:Expedited (15-DaCompany Report #NSADSS2001029004 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:10/02/01ISR Number: 3804211-5Report Type:Expedited (15-DaCompany Report #NSADSS2001028761 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Consumer Risperdal (2 Mg Tablet) (Risperidone) PS ORAL 2 MG, DAILY, ORAL Navane (Tiotixene) C Date:10/03/01ISR Number: 3805630-3Report Type:Expedited (15-DaCompany Report #EMADSS2001005486 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Catatonia Foreign Risperidone Neuroleptic Malignant Study (Unspecified) Syndrome Health (Risperidone) PS PATIENT HAD Professional PREVIOUSLY RECEIVED RISPERIDONE FROM Topiramate (Capsule) (Topiramate) SS ORAL 10 CAP, DAILY, ORAL Lorazepam (Lorazepam) C Chloral Hydrate (Chloral Hydrate) C Diazepam (Diazepam) C Olanzapine 22-Feb-2006 08:20 AM Page: 1113 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) C Senna (Senna) C Lactulose (Lactulose) C Haloperidol (Haloperidol) C Lithium Carbonate (Lithium Carbonate) C Date:10/03/01ISR Number: 3806839-5Report Type:Expedited (15-DaCompany Report #EMADSS2001005486 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Topiramate PS ORAL 10 CAP, DAILY Phosphokinase Increased Study ORAL Body Temperature Health Placebo (Placebo) SS ORAL 10 CAP, Increased Professional DAILY, ORAL Catatonia Risperidone Headache (Risperidone) SS PATIENT HAD Muscle Rigidity PREVIOUSLY Neuroleptic Malignant RECEIVED Syndrome RISPERIDONE Respiratory Failure FROM Lithium (Lithium) SS ORAL 10 CAP, DAILY, ORAL Lorazepam (Lorazepam) C Chloral Hydrate (Chloral Hydrate) C Diazepam (Diazepam) C Olanzapine (Olanzapine) C Senna (Senna) C Lactulose (Lactulose) C Haloperidol (Haloperidol) C Lithium Carbonate (Lithium Carbonate) C Date:10/05/01ISR Number: 3806093-4Report Type:Direct Company Report # Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Risperdal 0.25mg Confusional State Janssen PS Janssen ORAL 0.25MG BID & Haematuria Q 2H ORAL Sedation Levaquin C Urinary Tract Infection Detrol C White Blood Cells Urine Synthroid C Positive Prednisone C Date:10/08/01ISR Number: 3806572-XReport Type:Expedited (15-DaCompany Report #NSADSS2001029488 Age:83 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1114 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam (Lorazepam) SS ORAL ORAL Citalopram (Citalopram) SS ORAL ORAL Date:10/08/01ISR Number: 3806789-4Report Type:Expedited (15-DaCompany Report #APCDSS2001001310 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Foreign Risperdal (1 Mg Initial or Prolonged Facial Bones Fracture Health Tablet) Fall Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 Heart Rate Irregular Company DAY(S), ORAL Representative Date:10/09/01ISR Number: 3805685-6Report Type:Expedited (15-DaCompany Report #WAES 01091982 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Cozaar PS Merck & Co., Inc ORAL Initial or Prolonged Prolonged Professional Risperdal SS Mental Disorder Effexor C Depakote C Gemfibrozil C Date:10/10/01ISR Number: 3807859-7Report Type:Expedited (15-DaCompany Report #EMADSS2001000730 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Risperidone) PS ORAL 5 MG, DAILY, Professional ORAL Tavor (Lorazepam) C Date:10/10/01ISR Number: 3807863-9Report Type:Expedited (15-DaCompany Report #APCDSS2001001301 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Foreign Risperdal Initial or Prolonged Neoplasm Malignant Health (Unspecified) Other Neutropenia Professional (Risperidone) PS ORAL 0.5 MG, 1 IN 1 NIGHT(S) ORAL * SS * SS Date:10/10/01ISR Number: 3807864-0Report Type:Expedited (15-DaCompany Report #EMADSS2001005862 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Foreign Risperdal (1 Mg Parkinsonism Consumer Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAILY, ORAL; 0.25 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1115 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cipramil (Citalopram) SS ORAL 1 MG, 1 IN 1 DAILY, ORAL Date:10/10/01ISR Number: 3807865-2Report Type:Expedited (15-DaCompany Report #EMADSS2001005776 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Risperidone Initial or Prolonged Neuroleptic Malignant Health (Unspecified) Syndrome Professional (Risperidone) PS DOSAGE APPROX. 4 MG DAILY. THERAPY STOPPED ONE Date:10/10/01ISR Number: 3808183-9Report Type:Expedited (15-DaCompany Report #NSADSS2001029636 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Self-Injury Health Risperdal (3 Mg Thermal Burn Professional Tablet) (Risperidone) PS ORAL 3 MG, DAILY, ORAL Date:10/10/01ISR Number: 3808196-7Report Type:Expedited (15-DaCompany Report #NSADSS2001030331 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:10/10/01ISR Number: 3808197-9Report Type:Expedited (15-DaCompany Report #NSADSS2001030327 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal(Unspecifie Professional d) (Risperidone) PS ORAL ORAL Date:10/10/01ISR Number: 3808205-5Report Type:Expedited (15-DaCompany Report #NSADSS2001030477 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (0.5 Mg Health Tablet) Professional (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAILY, ORAL Date:10/10/01ISR Number: 3809659-0Report Type:Expedited (15-DaCompany Report #EMADSS2001005695 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Other Neutropenia Foreign Health 22-Feb-2006 08:20 AM Page: 1116 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal (Tablet) (Risperidone) PS ORAL 1.5 MG, 1 IN 1 DAILY, ORAL Xanef (Enalapril Maleate) C Metoprolol (Metoprolol) C Talvosilen (Acetaminophen/Codei ne) C Date:10/10/01ISR Number: 3809660-7Report Type:Expedited (15-DaCompany Report #EMADSS2001005732 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dental Caries Foreign Risperdal (1 Mg Teeth Brittle Health Tablet) Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 DAILY, ORAL Temesta (Lorazepam) SS ORAL 1 MG, ORAL Remeron (Mirtazapine) SS ORAL 60 MG, DAILY, ORAL Melleretten (Thioridazine Hydrochloride) SS ORAL 5 MG, ORAL Date:10/10/01ISR Number: 3809661-9Report Type:Expedited (15-DaCompany Report #EMADSS2001005876 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Risperdal (1 Mg Initial or Prolonged Renal Failure Chronic Health Tablet) Other Thrombocytopenia Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Zyloric (Allopurinol) SS Depamide (Valpromide) SS Tercian (Cyamemazine) SS Zoloft (Sertraline Hydrochloride) SS Un-Alfa (Alfacalcidol) SS Date:10/10/01ISR Number: 3809662-0Report Type:Expedited (15-DaCompany Report #EMADSS2001005514 Age:43 YR Gender:Male I/FU:F Outcome PT Other Chills Required Dysphagia Intervention to Epilepsy Prevent Permanent Hyperhidrosis Impairment/Damage Lung Infiltration 22-Feb-2006 08:20 AM Page: 1117 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Oliguria Report Source Product Role Manufacturer Route Dose Duration Sedation Foreign Risperidone (2 Mg Health Tablet) Professional (Risperidone) PS ORAL 2 MG, 3 IN 1 DAY(S), ORAL Thioridazine (Thioridazine) SS ORAL 100 MG, 1 IN 1 DAY(S), ORAL Biperiden (Biperiden) C Carbamazepine (Carbamazepine) C Diazepam (Diazepam) C Date:10/10/01ISR Number: 3809663-2Report Type:Expedited (15-DaCompany Report #NSADSS2001021988 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 4 MG, DAILY, ORAL Largactil (Chlorpromazine Hydrochloride) C Trazodone (Trazodone) C Date:10/16/01ISR Number: 3810545-0Report Type:Expedited (15-DaCompany Report #WAES 01091982 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Tab Cozaar 100 Mg PS ORAL PO Initial or Prolonged Prolonged Professional Risperdal SS Mental Disorder Depakote C Effexor C Gemfibrozil C Date:10/16/01ISR Number: 3810546-2Report Type:Expedited (15-DaCompany Report #WAES 01091982 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Tab Cozaar 100 Mg PS ORAL PO Initial or Prolonged Prolonged Professional Risperdal SS Mental Disorder Depakote C Effexor C Gemfibrozil C Date:10/17/01ISR Number: 3811098-3Report Type:Direct Company Report # Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erythema Multiforme Risperdal PS Initial or Prolonged Sunburn Cogentin C 22-Feb-2006 08:20 AM Page: 1118 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gentamicin Eye Drops C Date:10/19/01ISR Number: 3812208-4Report Type:Expedited (15-DaCompany Report #EMADSS2001006023 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Foreign Risperdal (Tablet) Health (Risperidone) PS ORAL 2 MG, 2 IN 1 Professional DAILY, ORAL Date:10/19/01ISR Number: 3812211-4Report Type:Expedited (15-DaCompany Report #EMADSS2001006022 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Disorder Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Mirtazapine (Mirtazapine) SS Lithium SS Date:10/19/01ISR Number: 3812213-8Report Type:Expedited (15-DaCompany Report #APCDSS2001001339 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Foreign Risperdal Initial or Prolonged Coma Health (Unspecified) Depressed Level Of Professional (Risperidone) PS ORAL 0.5 MG, 2 IN Consciousness Company 1 DAY (S), Drug Interaction Representative ORAL; 1 MG, 2 Lethargy IN 1 DAY (S), Muscle Rigidity ORAL Lithium (Lithium) SS ORAL 250 MG, 2 IN 1 DAY (S), ORAL; 500 MG, 2 IN 1 DAY (S), ORAL Date:10/19/01ISR Number: 3813083-4Report Type:Periodic Company Report #NSADSS2001019737 Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Health Risperdal (Solution) Initial or Prolonged Tachycardia Professional (Risperidone) PS ORAL 0.25 MG, Therapeutic Response DAILY, ORAL; Increased 2 MG, 1 IN 1 TIME(S), ORAL Date:10/23/01ISR Number: 3812874-3Report Type:Expedited (15-DaCompany Report #NSADSS2001031204 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1119 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/23/01ISR Number: 3813780-0Report Type:Expedited (15-DaCompany Report #APCDSS2001001310 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Foreign Risperdal (1 Mg Initial or Prolonged Dizziness Health Tablet) Facial Bones Fracture Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 Fall Company DAY(S), ORAL Heart Rate Irregular Representative Date:10/23/01ISR Number: 3813794-0Report Type:Expedited (15-DaCompany Report #NSADSS2001030720 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal (Tablet) Leukopenia Health (Risperidone) PS ORAL 4 MG, 1 IN 1 Professional DAY (S), ORAL Norvasc (Amlodipine Besilate) C Phenergan (Promethazine Hydrochloride) C Date:10/23/01ISR Number: 3813819-2Report Type:Expedited (15-DaCompany Report #APCDSS2001001332 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal Initial or Prolonged Phosphokinase Increased Health (Unspecified) Required Circulatory Collapse Professional (Risperidone) PS ORAL MG, ORAL Intervention to Compartment Syndrome Company Prevent Permanent Embolism Representative Impairment/Damage Infarction Loss Of Consciousness Muscle Disorder Date:10/23/01ISR Number: 3814146-XReport Type:Expedited (15-DaCompany Report #NSADSS2001021823 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Hypoxia Health Risperdal (2 Mg Hospitalization - Fall Professional Tablet) Initial or Prolonged Respiratory Failure (Risperidone) PS ORAL 2 MG, DAILY, ORAL Date:10/26/01ISR Number: 3816309-6Report Type:Expedited (15-DaCompany Report #HQ7460122OCT2001 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Electrolytes Consumer Effexor Xr Initial or Prolonged Decreased (Venlafaxine Insomnia Hydrochloride, Capsule Extended Release) PS Wyeth Labs (Ra) ORAL 75 MG 1X PER 1 DAY, ORAL Risperdal (Risperidone,) SS Ditropan 22-Feb-2006 08:20 AM Page: 1120 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Oxybutynin) C Premarin (Conjugated Estrogens) C Date:10/29/01ISR Number: 3816645-3Report Type:Expedited (15-DaCompany Report #NSADSS2001029488 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Literature Risperdal Required Distress Syndrome Health (Unspecified) Intervention to Arrhythmia Professional (Risperidone) PS ORAL ORAL Prevent Permanent Bradycardia Lorazepam Impairment/Damage Cardiac Arrest (Lorazepam) SS ORAL ORAL Coma Citalopram Hypoxia (Citalopram) SS ORAL ORAL Date:10/29/01ISR Number: 3816646-5Report Type:Expedited (15-DaCompany Report #NSADSS2001029321 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Health Risperdal (2 Mg Pneumonia Professional Tablet) (Risperidone) PS ORAL 2 MG,2 IN DAILY, ORAL Date:10/29/01ISR Number: 3816647-7Report Type:Expedited (15-DaCompany Report #NSADSS2001027513 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Health Risperdal Required Professional (Unspecified) Intervention to (Risperidone) PS ORAL 0.5 , DAILY, Prevent Permanent ORAL Impairment/Damage Paxil (Paroxetine Hydrochloride) C Klonopin (Clonazepam) C Sular (Nisoldipine) C Date:10/29/01ISR Number: 3816648-9Report Type:Expedited (15-DaCompany Report #NSADSS2001032482 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anhidrosis Consumer Risperdal (Tablet) Arrhythmia (Risperidone) PS ORAL 6 MG, DAILY, Carpal Tunnel Syndrome ORAL; SEE Neuropathy Peripheral IMAGE Oedema Peripheral Propulsid (Tablet) Pruritus (Cisapride) C Scab Lorazepam Tachycardia (Lorazepam) C Tardive Dyskinesia Zocor (Simvastatin) C Temperature Intolerance Mevacor (Lovastatin) C Tongue Coated Urinary Retention 22-Feb-2006 08:20 AM Page: 1121 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/01ISR Number: 3816649-0Report Type:Expedited (15-DaCompany Report #NSADSS2001032089 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Risperdal ( 1 Mg Initial or Prolonged Hypotension Professional Tablet) Myocardial Infarction (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY(S), ORAL Digoxin(Digoxin) C Date:10/29/01ISR Number: 3817091-9Report Type:Expedited (15-DaCompany Report #NSADSS2001032309 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Oedema Health Risperdal Initial or Prolonged Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:10/29/01ISR Number: 3817143-3Report Type:Expedited (15-DaCompany Report #EMADSS2001006220 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytoclastic Foreign Risperdal (Tablet) Vasculitis Health (Risperidone) PS ORAL 1 MG, 1 IN 1 Professional DAY(S), ORAL Thombran (Trazodone Hydrochloride) C Date:10/29/01ISR Number: 3817147-0Report Type:Expedited (15-DaCompany Report #EMADSS2001006146 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Folate Deficiency Foreign Risperdal (3 Mg Initial or Prolonged Hallucination Health Tablet) Normochromic Normocytic Professional (Risperidone) PS ORAL 3 MG, 1 IN 1 Anaemia DAY(S), ORAL Tercian (Cyamemazine) SS ORAL 20 DROPS, 1 IN 1 DAY(S), ORAL Date:10/29/01ISR Number: 3817149-4Report Type:Expedited (15-DaCompany Report #APCDSS2001001371 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal (Tablet) Health (Risperidone) PS ORAL 6 MG, DAILY, Professional ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS ORAL 150 MG, DAILY, ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL 300 MG, DAILY, ORAL Olanzapine 22-Feb-2006 08:20 AM Page: 1122 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Olanzapine) SS ORAL 5 MG, DAILY, ORAL Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Teprenone (Teprenone) C Date:10/30/01ISR Number: 3817361-4Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Risperdal PS Date:10/30/01ISR Number: 3817686-2Report Type:Expedited (15-DaCompany Report #NSADSS2001031776 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Feosol (Ferrous Sulfate) C Date:10/30/01ISR Number: 3817764-8Report Type:Expedited (15-DaCompany Report #EMADSS2001005776 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Foreign Risperidone Hospitalization - Syndrome Health (Unspecified) Initial or Prolonged Professional (Risperidone) PS SEE IMAGE Trazadone (Trazodone) C Gliclazide (Gliclazide) C Date:10/30/01ISR Number: 3817798-3Report Type:Expedited (15-DaCompany Report #NSADSS2001031633 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:10/30/01ISR Number: 3817799-5Report Type:Expedited (15-DaCompany Report #NSADSS2001031636 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1123 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/01ISR Number: 3817800-9Report Type:Expedited (15-DaCompany Report #NSADSS2001031770 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:10/31/01ISR Number: 3818489-5Report Type:Direct Company Report # Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Risperdal 2mg Initial or Prolonged Dysphagia Janssen PS Janssen ORAL 4MG QHS ORAL Dystonia Acupril C Extrapyramidal Disorder Tylenol C Headache Insomnia Muscle Spasms Date:11/01/01ISR Number: 3818486-XReport Type:Direct Company Report # Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatotoxicity Risperdal PS ORAL 1MG BID PO Initial or Prolonged Neuroleptic Malignant Depakote C Required Syndrome Cogentin C Intervention to Levaquin C Prevent Permanent Ativan C Impairment/Damage Date:11/01/01ISR Number: 3819881-5Report Type:Direct Company Report # Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Risperidone 1 Mg PS ORAL 1 MG BID ORAL Hospitalization - Syndrome Haldol 5 Mg SS INTRAMUSCULAR 5 MG IM OR PO Initial or Prolonged ORAL Disability Required Intervention to Prevent Permanent Impairment/Damage Date:11/02/01ISR Number: 3819930-4Report Type:Expedited (15-DaCompany Report #NSADSS2001033063 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:11/02/01ISR Number: 3819958-4Report Type:Expedited (15-DaCompany Report #01P-062-0112289-00 Age:31 YR Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:20 AM Page: 1124 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Foreign Tranxilium Tablets Electroencephalogram Health (Tranxene) Abnormal Professional (Clorazepate Grand Mal Convulsion Other Dipotassium) (Clorazepate PS ORAL 15 MG, 1 IN 1 D, PER ORAL; 20 MG, 1 IN 1 D, PER ORAL Amitriptyline Hydrochloride SS ORAL 200 MG, 1 IN 1 D, PER ORAL Risperidone SS ORAL 6 MG, 1 IN 1 D, PER ORAL Citalopram SS ORAL 20 MG, 1 IN 1 D, PER ORAL Date:11/02/01ISR Number: 3819983-3Report Type:Expedited (15-DaCompany Report #EMADSS2001006200 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Risperdal Hospitalization - Body Temperature Health (Unspecified) Initial or Prolonged Increased Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 Leukopenia DAY(S), ORAL Marcoumar (Phenprocoumon) C Digoxin (Digoxin) C Torem (Torsemide) C Aldactone (Spironolactone) C Date:11/02/01ISR Number: 3820029-1Report Type:Expedited (15-DaCompany Report #NSADSS2001032750 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Consumer Risperdal (Tablet) Initial or Prolonged Dehydration (Risperidone) PS ORAL ORAL Disability Finger Amputation "Psych Meds" C Required Hallucination "Vasoconstricters" C Intervention to Infection Prevent Permanent Multi-Organ Failure Impairment/Damage Neuroleptic Malignant Syndrome Pyrexia Serotonin Syndrome Toe Amputation Date:11/02/01ISR Number: 3820031-XReport Type:Expedited (15-DaCompany Report #NSADSS2001029636 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Thermal Burn Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, DAILY , ORAL 22-Feb-2006 08:20 AM Page: 1125 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/01ISR Number: 3820033-3Report Type:Expedited (15-DaCompany Report #NSADSS2001029495 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Literature Risperdal Required Anxiety Health (Risperidone) PS ORAL ORAL Intervention to Apnoea Professional Zolpidem (Zolpidem) SS ORAL ORAL Prevent Permanent Bundle Branch Block Buspirone Impairment/Damage Cardiac Arrest (Buspirone) SS ORAL ORAL Completed Suicide Luvox (Fluvoxamine Disorientation Maleate) C Dyspnoea Lithobid (Lithium Feeling Cold Carbonate) C Heart Rate Increased Levothyroxine Hyperhidrosis (Levothyroxine) C Hypotension Provera Overdose (Medroxyprogesterone Oxygen Saturation Acetate) C Decreased Docusate Sodium Respiratory Rate (Docusate Sodium) C Increased Skin Warm Date:11/02/01ISR Number: 3820035-7Report Type:Expedited (15-DaCompany Report #NSADSS2001029487 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Literature Risperdal Required Cardiac Arrest Health (Risperidone) PS ORAL ORAL Intervention to Completed Suicide Professional Amitriptyline Prevent Permanent Lethargy (Amitriptyline) SS Impairment/Damage Desipramine (Desipramine) SS Zoloft (Sertraline Hydrochloride) SS Date:11/02/01ISR Number: 3820037-0Report Type:Expedited (15-DaCompany Report #NSADSS2001029493 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Literature Risperdal Completed Suicide Health (Risperidone) PS ORAL ORAL Electrocardiogram Qrs Professional Trazodone Complex Prolonged (Trazodone) SS Heart Rate Increased Ethanol (Ethanol) SS Ventricular Fibrillation Date:11/02/01ISR Number: 3820039-4Report Type:Expedited (15-DaCompany Report #NSADSS2001029494 Age:53 YR Gender:Female I/FU:I Outcome PT Death Acidosis Aspartate Aminotransferase Increased Blood Amylase Increased Blood Creatinine Increased Blood Culture Positive 22-Feb-2006 08:20 AM Page: 1126 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coma Completed Suicide Coordination Abnormal Report Source Product Role Manufacturer Route Dose Duration Disorientation Literature Risperdal Feeling Cold Health (Risperidone) PS ORAL ORAL Hypotension Professional Venlafaxine Ileus Paralytic (Venlafaxine) SS Oliguria Oxygen Saturation Decreased Palpitations Pneumonia Aspiration Pupillary Disorder Renal Failure Sinus Tachycardia Skin Discolouration Streptococcal Infection Vomiting Date:11/02/01ISR Number: 3820042-4Report Type:Expedited (15-DaCompany Report #NSADSS2001029484 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Literature Risperdal Bradycardia Health (Unspecified) Cardiac Arrest Professional (Risperidone) PS ORAL ORAL Completed Suicide Haldol (Haloperidol) SS Confusional State Benztropine Sedation (Benztropine) SS Tachycardia Vomiting Date:11/05/01ISR Number: 3820465-3Report Type:Expedited (15-DaCompany Report #A120275 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Social Health Ziprasidone Po PS ORAL BID; ORAL Initial or Prolonged Behaviour Professional Risperdal SS DAILY Disability Nervous System Disorder Wellbutrin Sr C Required Tardive Dyskinesia Temazepam C Intervention to Effexor Xr C Prevent Permanent Synthroid C Impairment/Damage Estrogen C Provera C Coumadin C Date:11/05/01ISR Number: 3820694-9Report Type:Expedited (15-DaCompany Report #02676 Age:83 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Literature Lorazepam PS Risperidone SS Citalopram SS 22-Feb-2006 08:20 AM Page: 1127 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/01ISR Number: 3820695-0Report Type:Expedited (15-DaCompany Report #02681 Age:44 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Lorazepam PS Intentional Overdose Risperidone SS Date:11/05/01ISR Number: 3820804-3Report Type:Expedited (15-DaCompany Report #02683 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Trazodone PS Intentional Overdose Risperidone SS Date:11/06/01ISR Number: 3820932-2Report Type:Expedited (15-DaCompany Report #NSADSS2001033459 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:11/06/01ISR Number: 3821472-7Report Type:Expedited (15-DaCompany Report #APCDSS2001001392 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Foreign Risperdal (Tablet) Initial or Prolonged Depressed Level Of Health (Risperidone) PS ORAL 3 MG, DAILY, Consciousness Professional ORAL Water Intoxication Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:11/06/01ISR Number: 3821475-2Report Type:Expedited (15-DaCompany Report #EMADSS2001005819 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Circulatory Foreign Risperidone (Tablet) Initial or Prolonged Failure Study (Risperidone) PS 2 X 3 TABLETS Fall Health DAILY Haemorrhagic Stroke Professional Placebo (Placebo) SS 2 X 3 TABLETS DAILY Digoxin (Digoxin) C Pilocarpine (Pilocarpine) C Cinnarizine (Cinnarizine) C Oftensin (Timolol) C Verapamil Hydrochloride (Verapamil Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1128 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/01ISR Number: 3821477-6Report Type:Expedited (15-DaCompany Report #EMADSS2001005895 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Risperdal (0.5 Mg Arthralgia Health Tablet) Clonic Convulsion Professional (Risperidone) PS THERAPY DATES Clumsiness Company UNSPECIFIED Constipation Representative Seloken (Metoprolol Extrapyramidal Disorder Tartrate) C Leukocytosis Diltiazem Liver Function Test (Diltiazem) C Abnormal Seropram (Citalopram Myalgia Hydrobromide) C Urinary Incontinence Aricept (Donepezil Urinary Retention Hydrochloride) C Urinary Tract Infection Lexomil (Bromazepam) C Date:11/06/01ISR Number: 3821478-8Report Type:Expedited (15-DaCompany Report #EMADSS2001006354 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Solian (Amisulpride) SS Date:11/06/01ISR Number: 3821487-9Report Type:Expedited (15-DaCompany Report #EMADSS2001006355 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Risperdal Health (Risperidone) PS Professional Company Representative Date:11/06/01ISR Number: 3821490-9Report Type:Expedited (15-DaCompany Report #EMADSS2001006357 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Macrocytic Foreign Risperdal Leukocytosis Health (Unspecified) Professional (Risperidone) PS Sepram (Citalopram) C Date:11/06/01ISR Number: 3821493-4Report Type:Expedited (15-DaCompany Report #EMADSS2001005539 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Risperidone Initial or Prolonged Circulatory Collapse Health (Unspecified) Depressed Level Of Professional (Risperidone) PS Consciousness Thyroxin Hyponatraemia (Levothyroxine Urinary Incontinence Sodium) C 22-Feb-2006 08:20 AM Page: 1129 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/01ISR Number: 3822034-8Report Type:Expedited (15-DaCompany Report #A120625 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Convulsion Foreign Atarax Tablets PS ORAL 75 MG Intervention to Drug Interaction Health TOAL:TID:ORAL Prevent Permanent Muscle Rigidity Professional Venlafaxine SS ORAL 75.00 MG Impairment/Damage Pain Other TOTAL:DAILY:O RAL Risperidone SS ORAL 1.00 MG TOTAL:DAILY:O RAL Date:11/07/01ISR Number: 3822567-4Report Type:Expedited (15-DaCompany Report #NSADSS2001029484 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Literature Haldol (Haloperidol) PS Bradycardia Health Risperdal Cardiac Arrest Professional (Risperidone) SS ORAL ORAL Confusional State Benztropine Sedation (Benztropine) SS Tachycardia Vomiting Date:11/08/01ISR Number: 3821820-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradykinesia Haldol PS ORAL 5 MG II TABS Initial or Prolonged Sedation QHS ORAL Tremor Risperidal SS ORAL 1 MG BID ORAL Date:11/08/01ISR Number: 3822401-2Report Type:Direct Company Report # Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Risperdal PS 2MG Q AM & Initial or Prolonged Medication Error 3MG Q PM Neuroleptic Malignant Syndrome Date:11/08/01ISR Number: 3822467-XReport Type:Direct Company Report # Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Risperidone PS Glyburide C Acetaminophen C Hydrocortisone C Docusate Sodium C Baby Shampoo C Clopidogrel C Aspirin Ec C 22-Feb-2006 08:20 AM Page: 1130 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/01ISR Number: 3822807-1Report Type:Expedited (15-DaCompany Report #NSADSS2001033304 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY(S), ORAL Date:11/08/01ISR Number: 3822809-5Report Type:Expedited (15-DaCompany Report #NSADSS2001033565 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:11/08/01ISR Number: 3822810-1Report Type:Expedited (15-DaCompany Report #NSADSS2001033577 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Consumer Risperdal (Tablet) Hospitalization - (Risperidone) PS ORAL 6 MG, 3 IN 1 Initial or Prolonged DAY(S), ORAL Date:11/08/01ISR Number: 3822872-1Report Type:Expedited (15-DaCompany Report #APCDSS2001001392 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Foreign Risperdal (Tablet) Initial or Prolonged Depressed Level Of Health (Risperidone) PS ORAL 3 MG, DAILY, Consciousness Professional ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:11/08/01ISR Number: 3822929-5Report Type:Expedited (15-DaCompany Report #EMADSS2001006497 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Peroneal Nerve Palsy Foreign Risperdal (Tablet) Health (Risperidone) PS Professional Valproat (Valproic Company Acid) C Representative Date:11/08/01ISR Number: 3822930-1Report Type:Expedited (15-DaCompany Report #APCDSS2001001387 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disseminated Foreign Risperdal (Tablet) Initial or Prolonged Intravascular Coagulation Health (Risperidone) PS ORAL 10 MG, DAILY, Neuroleptic Malignant Professional ORAL Syndrome Promethazine Hydrochloride (Promethazine 22-Feb-2006 08:20 AM Page: 1131 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS ORAL 75 MG, DAILY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) SS ORAL 3 MG, DAILY, ORAL Vegetamin A (Vegetamin A) C Estazolam (Estazolam) C Triazolam (Triazolam) C Date:11/08/01ISR Number: 3823832-7Report Type:Expedited (15-DaCompany Report #NSADSS2001033536 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Risperdal Systemic Lupus Health (Unspecified) Erythematosus Professional (Risperidone) PS Date:11/09/01ISR Number: 3823217-3Report Type:Direct Company Report # Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Tenderness Risperdal 1mg PS ORAL 1 MG TID ORAL Required Gynaecomastia Prozac SS ORAL 60 MG QAM Intervention to ORAL Prevent Permanent Naltrexone C Impairment/Damage Trazodone C Benadryl C Quetiapine C Date:11/13/01ISR Number: 3824778-0Report Type:Expedited (15-DaCompany Report #NSADSS2001034019 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:11/13/01ISR Number: 3824779-2Report Type:Expedited (15-DaCompany Report #NSADSS2001033824 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS Date:11/13/01ISR Number: 3824818-9Report Type:Expedited (15-DaCompany Report #NSADSS2001034121 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Phenobarbital (Phenobarbital) C 22-Feb-2006 08:20 AM Page: 1132 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/01ISR Number: 3825260-7Report Type:Expedited (15-DaCompany Report #NSADSS2001034179 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:11/13/01ISR Number: 3825616-2Report Type:Expedited (15-DaCompany Report #NSADSS2001033881 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:11/13/01ISR Number: 3826058-6Report Type:Expedited (15-DaCompany Report #EMADSS2001006354 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal (2 Mg Initial or Prolonged Health Tablet) Other Professional (Risperidone) PS ORAL 2 MG, 2 IN 1 DAILY, ORAL Seroquel (Seroquel) SS ORAL 100 MG, 2 IN 1 DAILY, ORAL Date:11/13/01ISR Number: 3826060-4Report Type:Expedited (15-DaCompany Report #EMADSS2001006501 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Neutropenia Health (Risperidone) PS ORAL 1 MG; 2 MG; 3 Professional MG, 1 IN 1 DAYS (S), ORAL Orfiril (Valproate Sodium) C Cipramil (Citalopram) C Aquaphor (Aquaphor) C Kalinor (Potassium Chloride) C Date:11/16/01ISR Number: 3825921-XReport Type:Expedited (15-DaCompany Report #NSADSS2001034303 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, 1 IN 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 1133 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/01ISR Number: 3825923-3Report Type:Expedited (15-DaCompany Report #NSADSS2001034185 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY(S), ORAL Date:11/16/01ISR Number: 3825926-9Report Type:Expedited (15-DaCompany Report #NSADSS2001026744 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Chloride Increased Study Risperdal Initial or Prolonged Bradycardia Health (Risperidone) PS 1 MG, Coma Professional Topiramate Convulsion (Unspecified) Lethargy (Topiramate) SS ORAL 1000 MG, ORAL Medication Error Atenolol (Atenolol) SS 50 MG Pco2 Decreased Cogentin Sedation (Benzatropine Mesilate) SS 2 MG Clozaril (Clozapine) SS 30 MG Depakote (Valproate Semisodium) SS 200 MG Lamictal (Lamotrigine) C Dilantin (Phenytoin Sodium) C Date:11/16/01ISR Number: 3827589-5Report Type:Expedited (15-DaCompany Report #EMADSS2001005514 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Infiltration Foreign Risperidone (2 Mg Initial or Prolonged Neuroleptic Malignant Health Tablet) Other Syndrome Professional (Risperidone) PS ORAL 2 MG, 3 IN 1 Required DAY(S), ORAL Intervention to Thioridazine Prevent Permanent (Thioridazine) SS ORAL 100 MG, 1 IN Impairment/Damage 1 DAY(S), ORAL Biperiden (Biperiden) C Carbamazepine (Carbamazepine) C Diazepam (Diazepam) C Date:11/16/01ISR Number: 3827590-1Report Type:Expedited (15-DaCompany Report #EMADSS2001006501 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Neutropenia Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL; 2 MG, 1 IN 1 DAY(S); ORAL; 3 MG, 1 IN 1 22-Feb-2006 08:20 AM Page: 1134 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Orfiril (Valproate Sodium) C Cipramil (Citalopram) C Aquaphor (Aquaphor) C Kalinor (Potassium Chloride) C Date:11/16/01ISR Number: 3827591-3Report Type:Expedited (15-DaCompany Report #EMADSS2001006355 Age:93 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperidone (1 Mg Initial or Prolonged Health Tablet) Other Professional (Risperidone) PS ORAL 1 MG, DAILY, Company ORAL Representative Lanitop (Metildigoxin) C Furosemide (Furosemide) C Lisinopril (Lisinopril) C Madopar (Madopar) C Date:11/16/01ISR Number: 3827592-5Report Type:Expedited (15-DaCompany Report #APCDSS2001001387 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Risperdal (Tablet) Hospitalization - Phosphokinase Increased Health (Risperidone) PS ORAL 10 MG, DAILY, Initial or Prolonged Dehydration Professional ORAL Depressed Level Of Promethazine Consciousness Hydrochloride Disseminated (Promethazine Intravascular Coagulation Hydrochloride) C Dyspnoea Biperiden Hyperhidrosis Hydrochloride Hypoxia (Biperiden Muscle Rigidity Hydrochloride) C Neuroleptic Malignant Vegetamin A Syndrome (Vegetamin A) C Polydipsia Pyrexia Tachycardia Therapeutic Agent Toxicity Tremor Urinary Incontinence Date:11/16/01ISR Number: 3827593-7Report Type:Expedited (15-DaCompany Report #APCDSS2001001408 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Foreign Risperdal (2 Mg Required Health Tablet) Intervention to Professional (Risperidone) PS ORAL 2 MG, 2 IN 1 Prevent Permanent Company DAY(S), ORAL Impairment/Damage Representative Temazepam 22-Feb-2006 08:20 AM Page: 1135 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Temazepam0 C Thiamine (Thiamine) C Metoclopramide (Metoclopramide) C Phosphate - Sandoz (Phosphate-Sandoz) C Paracetamol (Paracetamol) C Date:11/19/01ISR Number: 3825848-3Report Type:Expedited (15-DaCompany Report #WAES 01111659 Age:29 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Cogentin PS Merck & Co., Inc ORAL Completed Suicide Risperidone SS Charcoal, Activated SS Date:11/20/01ISR Number: 3828182-0Report Type:Expedited (15-DaCompany Report #PHBS2001US11287 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Literature Clozaril (Clozapine) Initial or Prolonged Increased Health Unknown PS 350 MG/DAY Blood Triglycerides Professional Risperidone Increased (Risperidone) SS Diabetes Mellitus Non-Insulin-Dependent Erectile Dysfunction Galactorrhoea Weight Increased Date:11/20/01ISR Number: 3828183-2Report Type:Expedited (15-DaCompany Report #PHBS2001US11286 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Clozaril (Clozapine) Initial or Prolonged Blood Cholesterol Health Unknown PS Increased Professional Risperidone Blood Triglycerides (Risperidone) SS Increased Diabetes Mellitus Non-Insulin-Dependent Weight Increased Date:11/20/01ISR Number: 3830726-XReport Type:Periodic Company Report #PHEH2000US09221 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Sodium Decreased Health Clozaril (Clozapine) Hospitalization - Convulsion Professional Tablet PS ORAL 700 MG, ORAL Initial or Prolonged Delirium Ddavp (Desmopressin) SS 0.2 MG, Pollakiuria ONCE/SINGLE Polydipsia Risperdal (Risperidone) SS 4 MG 366 DAY Accupril (Quinapril Hydrochloride) SS ORAL 20 MG, ORAL 22-Feb-2006 08:20 AM Page: 1136 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/01ISR Number: 3830777-5Report Type:Periodic Company Report #PHEH2000US10929 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Other Clozaril(Clozapine) Tablet PS ORAL ORAL Risperdal(Risperidon e) SS ORAL 2 MG, QD, ORAL Risperdal Regiment #2 SS ORAL 3 MG, QD, ORAL Risperdal Regiment #3 SS ORAL 2 MG, QD, ORAL Risperdal Regiment #4 SS ORAL 5 MG, QD, ORAL Risperdal Regiment #5 SS ORAL 3 MG, BID, ORAL Zyprexa(Olanzapine) SS ORAL ORAL Benztropine (Benzatropine Mesilate) C Lorazepam C Date:11/26/01ISR Number: 3829358-9Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erection Increased Risperidone Conc. 3 Initial or Prolonged Pain Mg Po Bid (Janssen) PS Janssen ORAL 3MG PO BID Required Intervention to Prevent Permanent Impairment/Damage Date:11/26/01ISR Number: 3830042-6Report Type:Expedited (15-DaCompany Report #WAES 01111659 Age:29 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Tab Cogentin PS ORAL PO Health Risperidone SS Professional Charcoal, Activated SS Date:11/27/01ISR Number: 3831707-2Report Type:Expedited (15-DaCompany Report #GB/00/00576/MEL Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Foreign Thioridazine(Thiorid Health azine Hydrochloride) PS ORAL 400 MG, QD ; Professional 200 MG, QD, Other ORAL Risperidone (Risperidone) SS ORAL 8 MG OR 9 MG/DAY, ORAL ; 10 MG/DAY, ORAL 22-Feb-2006 08:20 AM Page: 1137 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depixol (Flupentixol Decanoate) SS Sertraline (Sertraline) C Omeprazole (Omeprazole) C Zopiclone C Date:11/28/01ISR Number: 3831401-8Report Type:Expedited (15-DaCompany Report #200122703US Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Fexofenadine Syncope Professional Hydrochloride (Allegra) PS ORAL PO Risperidone (Risperdal) SS ORAL PO Date:11/28/01ISR Number: 3831420-1Report Type:Expedited (15-DaCompany Report #NSADSS2001035264 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Risperdal (4 Mg Initial or Prolonged Cellulitis Tablet) Insomnia (Risperidone) PS ORAL 2 MG, 2 IN 1 Sleep Disorder DAY (S), ORAL Coumadin (Warfarin Sodium) C Ativan (Lorazepam) C Date:11/28/01ISR Number: 3831421-3Report Type:Expedited (15-DaCompany Report #NSADSS2001035600 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:11/28/01ISR Number: 3831435-3Report Type:Expedited (15-DaCompany Report #NSADSS2001031770 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL SEE IMAGE Luvox (Fluvoxamine Maleate) C Date:11/28/01ISR Number: 3831475-4Report Type:Expedited (15-DaCompany Report #NSADSS2001035086 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Depression Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1138 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/01ISR Number: 3831513-9Report Type:Expedited (15-DaCompany Report #NSADSS2001035083 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS 3 MG, 2 IN 1 DAY(S) Date:11/28/01ISR Number: 3831514-0Report Type:Expedited (15-DaCompany Report #NSADSS2001035080 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Date:11/28/01ISR Number: 3831534-6Report Type:Expedited (15-DaCompany Report #EMADSS2001005514 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Foreign Risperidone Initial or Prolonged Lung Infiltration Health (Risperidone) PS ORAL 2 MG, 3 IN 1 Other Neuroleptic Malignant Professional DAY(S), ORAL Required Syndrome Thioridazine Intervention to Oliguria (Thioridazine) SS ORAL 100 MG, 1 IN Prevent Permanent 1 DAY(S), Impairment/Damage ORAL Biperiden (Biperiden) C Carbamazepine (Carbamazepine) C Diazepam (Diazepam) C Date:11/28/01ISR Number: 3831535-8Report Type:Expedited (15-DaCompany Report #APCDSS2001001392 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Risperdal (Tablet) Initial or Prolonged Hyponatraemia Health (Risperidone) PS ORAL 3 MG, DAILY, Loss Of Consciousness Professional ORAL Urinary Incontinence Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:11/28/01ISR Number: 3831536-XReport Type:Expedited (15-DaCompany Report #EMADSS2001006672 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cataract Foreign Risperidone Health (Unspecified) Professional (Risperidone) PS DOSAGE AND FREQUENCY 22-Feb-2006 08:20 AM Page: 1139 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/01ISR Number: 3831769-2Report Type:Expedited (15-DaCompany Report #NSADSS2001035089 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:11/28/01ISR Number: 3832031-4Report Type:Expedited (15-DaCompany Report #2001081702FR Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Xanax (Alprazolam) PS ORAL 1.5MG/DAY, Initial or Prolonged Neutropenia Other ORAL White Blood Cell Disorder Imovane (Zopiclone) SS ORAL 7.5 MG/DAY, ORAL Risperdal (Risperidone) SS ORAL ORAL Depamide (Valpromide) SS ORAL ORAL Date:11/28/01ISR Number: 3832069-7Report Type:Expedited (15-DaCompany Report #S01-FRA-02303-01 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Seropram(Citalopram Bronchopneumonia Health Hydrobromide) PS ORAL 40 MG QD PO Pleural Effusion Professional Atarax (Hydroxyzine Respiratory Arrest Other Hydrochloride) SS ORAL 25 MG QD PO Respiratory Distress Tranxene(Clorazepate Respiratory Failure Dipotassium) SS ORAL 40 MG QD PO Risperdal (Risperidone) SS ORAL 2 MG QD PO Date:11/28/01ISR Number: 3832126-5Report Type:Expedited (15-DaCompany Report #EMADSS2001006593 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Risperidone Initial or Prolonged Myositis Health (Unspecified) Pulse Abnormal Professional (Risperidone) PS ORAL ORAL Pyrexia Mirtazapine (Mirtazapine) SS ORAL 30 MG, DAILY, ORAL Date:11/28/01ISR Number: 3832128-9Report Type:Expedited (15-DaCompany Report #EMADSS2001004170 Age:10 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperidone (1 Mg/Ml Epistaxis Health Solution) Professional (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAY (S), ORAL 22-Feb-2006 08:20 AM Page: 1140 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/01ISR Number: 3832433-6Report Type:Expedited (15-DaCompany Report #APCDSS2001001352 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Breast Neoplasm Foreign Risperdal (1 Mg Required Mastectomy Health Tablet) Intervention to Pigmentation Disorder Professional (Risperidone) PS ORAL MG, DAILY, Prevent Permanent Purpura ORAL Impairment/Damage Urticaria Brotizolam (Brotizolam) C Lormetazepam (Lormetazepam) C Sennoside (Sennosides) C Date:11/28/01ISR Number: 3832437-3Report Type:Expedited (15-DaCompany Report #APCDSS2001001382 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Risperdal (Tablet) Hospitalization - Increased Health (Risperidone) PS ORAL 0.5 MG, Initial or Prolonged Blood Alkaline Professional DAILY, ORAL Phosphatase Increased Fluvoxamine Maleate Blood Lactate (Fluvoxamine Dehydrogenase Increased Maleate) SS ORAL 50 MG, DAILY, Gamma-Glutamyltransferase ORAL Increased Sennoside Hepatic Function Abnormal (Sennoside) C Laboratory Test Abnormal Brotizolam Loss Of Consciousness (Brotizolam) C Sepsis Urinary Tract Infection Date:11/28/01ISR Number: 3832440-3Report Type:Expedited (15-DaCompany Report #EMADSS2001006738 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chronic Obstructive Foreign Risperdal (2 Mg Hospitalization - Pulmonary Disease Health Tablet) Initial or Prolonged Lower Respiratory Tract Professional (Risperidone) PS ORAL 2 MG, DAILY, Required Infection ORAL Intervention to Oxygen Saturation Seropram (Citalopram Prevent Permanent Decreased Hydrobromide) SS ORAL 2 CAP, DAILY, Impairment/Damage Pleural Effusion ORAL Respiratory Arrest Atarax (Hydroxyzine White Blood Cell Count Hydrochloride) SS ORAL 25 MG, DAILY, Increased ORAL Tranxene (Clorazepate Dipotassium) SS ORAL 40 MG, DAILY, ORAL Date:11/28/01ISR Number: 3832444-0Report Type:Expedited (15-DaCompany Report #EMADSS2001006754 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Inflammation Foreign Risperdal Lipase Increased Health (Risperidone) PS ORAL 3 MG, DAILY, Professional ORAL 22-Feb-2006 08:20 AM Page: 1141 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/01ISR Number: 3832446-4Report Type:Expedited (15-DaCompany Report #EMADSS2001006797 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aplastic Anaemia Foreign Risperdal(Tablet)(Ri Dyspnoea Health speridone) PS ORAL 2 TABLET, 3 Haematoma Professional IN 1 DAILY, ORAL Thiamazol(Thiamazol) SS ORAL 1 TABLE, 1 IN 1 DAILY, ORAL Chloraldurat(Chloral Hydrate) C Ass(Acetylsalicylic Acid) C Iron(Iron) C Allopurinol(Allopuri nol) C Date:11/28/01ISR Number: 3832449-XReport Type:Expedited (15-DaCompany Report #NSADSS2001035621 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Date:11/28/01ISR Number: 3832450-6Report Type:Expedited (15-DaCompany Report #EMADSS2001006497 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypoaesthesia Foreign Risperdal(Tablet)(Ri Health speridone) PS 3 - 4 MG Professional DAILY Company Valproat(Valproic Representative Acid) C Date:11/28/01ISR Number: 3832453-1Report Type:Expedited (15-DaCompany Report #APCDSS2001001387 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Risperdal(Tablet)(Ri Hospitalization - Disseminated Health speridone) PS ORAL 10 MG, DAILY, Initial or Prolonged Intravascular Coagulation Professional ORAL Neuroleptic Malignant Promethazine Syndrome Hydrochloride(Promet Polydipsia hazine Therapeutic Agent Hydrochloride) C Toxicity Biperiden Hydrochloride(Biperi den Hydrochloride) C Vegetamin A (Vegetamin A) C 22-Feb-2006 08:20 AM Page: 1142 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/01ISR Number: 3832686-4Report Type:Direct Company Report # Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paraesthesia Risperdal 2 Mg Initial or Prolonged Tremor Janssen PS Janssen ORAL 2 MG QHS ORAL Celebrex C Disulfiram C Effexor C Levothyroxine C Remeron C Acetaminophen C Date:11/29/01ISR Number: 3839628-6Report Type:Periodic Company Report #US_010566708 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Urinary Tract Infection Study Risperidone PS 1 DSG FORM Initial or Prolonged Health DAY Professional Olanzapine SS 3.75 MG DAY Hyoscyamine C Dorzolamide C Sertraline C Furosemide C Date:11/30/01ISR Number: 3833060-7Report Type:Expedited (15-DaCompany Report #APCDSS2001001392 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Risperdal (Tablet) Initial or Prolonged Drug Level Above Health (Risperidone) PS ORAL 3 MG, DAILY, Therapeutic Professional ORAL Hyponatraemia Biperiden Inappropriate Hydrochloride Antidiuretic Hormone (Biperiden Secretion Hydrochloride) C Loss Of Consciousness Urinary Incontinence Date:11/30/01ISR Number: 3833061-9Report Type:Expedited (15-DaCompany Report #EMADSS2001006357 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Macrocytic Foreign Risperdal Leukocytosis Health (Unspecified) Professional (Risperidone) PS THERAPY DETAILS NOT PROVIDED Sepram (Citalopram) C Date:11/30/01ISR Number: 3833064-4Report Type:Expedited (15-DaCompany Report #EMADSS2001006023 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Foreign Risperdal (Tablet) Health (Risperidone) PS ORAL 2 MG, 2 IN 1 Professional DAY (S), ORAL 22-Feb-2006 08:20 AM Page: 1143 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/01ISR Number: 3833071-1Report Type:Expedited (15-DaCompany Report #APCDSS2001001451 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Foreign Risperidone (Tablet) Electrocardiogram Health (Risperidone) PS ORAL 4 MG, DAILY, Abnormal Professional ORAL Date:11/30/01ISR Number: 3833073-5Report Type:Expedited (15-DaCompany Report #NSADSS2001035899 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Date:11/30/01ISR Number: 3833607-0Report Type:Expedited (15-DaCompany Report #A127059 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bronchopneumonia Foreign Atarax Tablets PS ORAL 25.00 MG Obstructive Airways Health TOTAL: DAILY: Disorder Professional ORAL Pleural Effusion Tranxene SS ORAL 50.00 MG Respiratory Distress TOTAL: DAILY: ORAL Seropram SS BID Risperdal SS 2.00 MG TOTAL: DAILY Date:12/04/01ISR Number: 3833108-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Increased Risperdal -(Janssen) PS Janseen ORAL 1 MG PO BID Hypertensive Crisis Date:12/04/01ISR Number: 3834698-3Report Type:Expedited (15-DaCompany Report #EMADSS2001006997 Age:16 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperidone Platelet Count Decreased Health (Unspecified) Professional (Risperidone) PS Date:12/04/01ISR Number: 3834701-0Report Type:Expedited (15-DaCompany Report #APCDSS2001001339 Age:93 YR Gender:Male I/FU:F Outcome PT Hospitalization - Depressed Level Of Initial or Prolonged Consciousness Drug Interaction Dysphagia Hyperreflexia Lethargy Muscle Rigidity Muscle Twitching 22-Feb-2006 08:20 AM Page: 1144 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Musculoskeletal Stiffness Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Urinary Tract Infection Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL SEE IMAGE Company Lithium (Lithium) SS ORAL SEE IMAGE Representative Date:12/04/01ISR Number: 3834714-9Report Type:Expedited (15-DaCompany Report #EMADSS2001006706 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Exfoliative Foreign Haldol(5 Mg Initial or Prolonged Erythema Health Tablet)(Haloperidol) PS ORAL 5 MG, 2 IN 1 Required Rash Pustular Professional DAY(S), ORAL Intervention to Risperdal(Solution)( Prevent Permanent Risperdone) SS ORAL 8 MG, DAILY, Impairment/Damage ORAL Tercian(Cyamemazine) C Depamide(Valpromide) C Parkinane(Trihexyphe nidyl Hydrochloride) C Date:12/04/01ISR Number: 3834830-1Report Type:Expedited (15-DaCompany Report #NSADSS2001036452 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAILY, ORAL Date:12/04/01ISR Number: 3834833-7Report Type:Expedited (15-DaCompany Report #NSADSS2001036106 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Embolism Consumer Risperdal (2 Mg Initial or Prolonged Tablet) (Risperidone) PS ORAL 2 MG, 1 IN 24 HOUR(S), ORAL Clonopin (Clonazepam) C Provigil (Modafinil) C Coumadin (Warfarin Sodium) C Paxil (Paroxetine Hydrochloride) C Date:12/05/01ISR Number: 3834841-6Report Type:Expedited (15-DaCompany Report #NSADSS2001036550 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Consumer Risperdal (1 Mg Purpura Tablet) Weight Increased (Risperidone) PS ORAL 1 MG, 1 IN 24 HOUR(S), ORAL 22-Feb-2006 08:20 AM Page: 1145 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium (Lithium) C Date:12/05/01ISR Number: 3834844-1Report Type:Expedited (15-DaCompany Report #NSADSS2001036620 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cough Health Risperdal (Tablet) Intervention to Dysphagia Professional (Risperidone) PS ORAL 7 MG, DAILY, Prevent Permanent Laryngeal Polyp ORAL Impairment/Damage Nausea Rectal Cancer Vomiting Date:12/05/01ISR Number: 3835075-1Report Type:Expedited (15-DaCompany Report #EMADSS2001006913 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Arrest Foreign Risperidone Hospitalization - Health (Unspecified) Initial or Prolonged Professional (Risperidone) PS 1 MG Required Trazodone Intervention to (Trazodone) C Prevent Permanent Sodium Valproate Impairment/Damage (Valproate Sodium) C Aspirin (Acetylsalicylic Acid) C Captopril (Captopril) C Frusemide (Furosemide) C Atenolol (Atenolol) C Ismo (Isosorbide Mononitrate) C Date:12/05/01ISR Number: 3835443-8Report Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Respiridone PS Intervention to Syndrome Prevent Permanent Impairment/Damage Date:12/05/01ISR Number: 3836318-0Report Type:Direct Company Report # Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Risperdal PS Date:12/06/01ISR Number: 3836566-XReport Type:Expedited (15-DaCompany Report #HQ7460122OCT2001 Age:68 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 1146 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Blood Electrolytes Health Effexor Xr Decreased Professional (Venlafaxine Catatonia Hydrochloride, Confusional State Capsule, Extended Depression Release) PS ORAL 75 MG 1X PER Insomnia 1 DAY, ORAL Loose Associations Risperdal Schizophreniform Disorder (Risperidone, ) SS Waxy Flexibility Ditropan (Oxybutynin) C Premarin (Conjugated Estrogens) C Date:12/06/01ISR Number: 3837166-8Report Type:Expedited (15-DaCompany Report #EMADSS2001004094 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Risperidone (Tablet) Initial or Prolonged Neutropenia Health (Risperidone) PS ORAL SEE IMAGE Professional Xanax (Alprazolam) C Imovane (Zopiclone) C Depamide (Valpromide) C Date:12/07/01ISR Number: 3836518-XReport Type:Direct Company Report # Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Resperdal (Janssen Other Decreased Activity Pharmaceutica Drooling Products) PS Janssen Respiratory Disorder Pharmaceutical Products 1-4MG, ONCE DAILY 047 Lithium C Neurontin C Paxil C Prophylthiaurcil C Augmentin C Tenormin C Lactose C Amoxicillin C Date:12/07/01ISR Number: 3837149-8Report Type:Expedited (15-DaCompany Report #2001082086US Age:45 YR Gender:Male I/FU:I Outcome PT Other Blood Pressure Decreased Delirium Delusion Drug Interaction Dry Mouth Haematocrit Decreased Haemoglobin Decreased Hallucination, Visual 22-Feb-2006 08:20 AM Page: 1147 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mydriasis Respiratory Rate Increased Report Source Product Role Manufacturer Route Dose Duration Serotonin Syndrome Health Linezolid(Linezolid) Vomiting Professional Solution, Sterile PS INTRAVENOUS 600 MG, BID, White Blood Cell Count IV Increased Flagyl (Metronidazole) Tablet SS ORAL 500 MG, QID, ORAL Sertraline(Sertralin e) SS 200 MG, QD, Risperidone(Risperid one) SS 1 MG, BID, Bupropion (Amfebutamone) SS 75 MG, BID Trazodone C Litiumkarbonat (Lithium Carbonate) C Baclofen C Promethazine(Prometh azine) C Docusate Sodium(Docusate Sodium) C Bisacodyl(Bisacodyl) C Megestrol(Megestrol) C Lansoprazole C Date:12/07/01ISR Number: 3837635-0Report Type:Expedited (15-DaCompany Report #NSADSS2001036822 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Risperdal Neutropenia Health (Risperidone) PS Professional Date:12/07/01ISR Number: 3837695-7Report Type:Expedited (15-DaCompany Report #NSADSS2001036840 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:12/12/01ISR Number: 3838977-5Report Type:Direct Company Report # Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Risperidone (4 Initial or Prolonged Disturbance In Attention Miligrams) 2 Times Dizziness Daily Liquid PS 4 MILLIGRAMS Dysgraphia 2 TIMES DAILY Fatigue LIQUID Lethargy Memory Impairment Speech Disorder Vision Blurred 22-Feb-2006 08:20 AM Page: 1148 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/01ISR Number: 3838997-0Report Type:Direct Company Report # Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Remeron PS ORAL 15 MG DAILY Intervention to Dementia PO Prevent Permanent Disorientation Risperdal Janssen SS Janssen ORAL 1 MG DAILY PO Impairment/Damage Mental Impairment Personality Change Date:12/12/01ISR Number: 3839157-XReport Type:Direct Company Report # Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Risperdal 2 Mg PS ORAL 2 MG QHS ORAL Initial or Prolonged Facial Bones Fracture Effexor C Fall Remeron C Orthostatic Hypotension Trazodone C Date:12/12/01ISR Number: 3840220-8Report Type:Expedited (15-DaCompany Report #01-1953 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Foreign Loxitane (Loxapac) Hospitalization - Somnolence Health Capsules PS Wyeth Ayerst ORAL 15 MG 1 X PER Initial or Prolonged Professional 1 DAY, ORAL 305 DAY Company Risperdal Representative (Risperidone), Manufacturer Unknown SS ORAL 500 UG 1 X PER 1 DAY, ORAL 28 DAY Serenase (Haloperidol) SS ORAL 2 MG 1 X PER 1 DAY, ORAL 305 DAY Zyprexa (Olanzapine) SS ORAL 2.5 MG 1 X PER 1 DAY, ORAL 301 DAY Date:12/12/01ISR Number: 3840250-6Report Type:Expedited (15-DaCompany Report #01P-056-0113630-00 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Lung Disorder Foreign Tranxene Tablets Hospitalization - Pleural Effusion Health (Tranxene) Initial or Prolonged Pneumonia Professional (Clorazepate Required Respiratory Arrest Other Dipotassium) Intervention to Respiratory Distress (Clorazepate PS ORAL 20 MG, 2 IN 1 Prevent Permanent Sedation D, PER ORAL Impairment/Damage Citalopram Hydrobromide SS ORAL 2 UNIT, 1 IN 1 D, PER ORAL Hydroxyzine Hydrochloride SS ORAL 25 MG, 1 IN 1 D, PER ORAL Risperidone SS ORAL 2 MG, 1 IN 1 D, PER ORAL Tranxene Injectable (Clorazepate Dipotassium 22-Feb-2006 08:20 AM Page: 1149 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Injection) (Clorazepate C Date:12/13/01ISR Number: 3839372-5Report Type:Expedited (15-DaCompany Report #NSADSS2001033459 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS 1 MG , 2 IN 1 DAY(S) Date:12/13/01ISR Number: 3839403-2Report Type:Expedited (15-DaCompany Report #EMADSS2001007112 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Foreign Haldol (Unspecified) Somnolence Health (Haloperidol) PS ORAL 2 MG, DAILY, Professional ORAL Risperidone (Unspecified) (Risperidone) SS ORAL 500 MCG, DAILY, ORAL Loxapac (Loxapine Succinate) SS ORAL 15 MG, DAILY. ORAL Olanzapine (Olanzapine) SS ORAL 2.5 MG, DAILY, ORAL Date:12/13/01ISR Number: 3839408-1Report Type:Expedited (15-DaCompany Report #NSADSS2001036103 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:12/13/01ISR Number: 3839806-6Report Type:Expedited (15-DaCompany Report #EMADSS2001004094 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Risperidone (Tablet) Initial or Prolonged Neutropenia Health (Risperidone) PS ORAL 2 MG, DAILY, Professional ORAL Xanax (Alprazolam) SS 1.5 MG, UNKNOWN Imovane (Zopiclone) SS ORAL 1 TABLET, DAILY, ORAL Depamide (Valpromide) SS ORAL 4 TABLET, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1150 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/01ISR Number: 3839807-8Report Type:Expedited (15-DaCompany Report #EMADSS2001007008 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Risperdal Initial or Prolonged First Degree Health (Risperidone) PS ORAL 1 MG, 1 IN 1 Blood Pressure Diastolic Professional DAY(S), ORAL Decreased Equanil Body Temperature (Meprobamate) SS ORAL 250 MG, 2 IN Increased 1 DAY(S), Bradycardia ORAL Cardiac Disorder Lexomil (Bromazepam) SS ORAL 3 MG, 1 IN 1 Cardiac Murmur DAY(S), ORAL Headache Aricept (Donepezil Malaise Hydrochloride) C Vomiting Date:12/13/01ISR Number: 3839808-XReport Type:Expedited (15-DaCompany Report #EMADSS2001006928 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticholinergic Syndrome Foreign Risperdal Initial or Prolonged Chills Health (Unspecified) Dry Mouth Professional (Risperidone) PS ORAL 1 MG, ORAL Extrapyramidal Disorder Diazepam (Diazepam) C Somnolence Fevarin (Fluvoxamine Maleate) C Date:12/13/01ISR Number: 3840331-7Report Type:Expedited (15-DaCompany Report #EMADSS2001005486 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Risperidone Phosphokinase Increased Study (Unspecified) Body Temperature Health (Risperidone) PS PATIENT HAD Increased Professional PREVIOUSLY Catatonia RECEIVED Dysphagia RISPERIDONE Headache FROM Muscle Rigidity Topiramate (Capsule) Neuroleptic Malignant (Topiramate) SS ORAL 3 CAP, DAILY, Syndrome ORAL Respiratory Failure Placebo (Placebo) SS ORAL 3 CAP, DAILY, Speech Disorder ORAL Lithium (Lithium) SS ORAL 3 CAP, DAILY, ORAL Lorazepam (Lorazepam) C Chloral Hydrate (Chloral Hydrate) C Diazepam (Diazepam) C Olanzapine (Olanzapine) C Senna (Senna) C Lactulose (Lactulose) C Haloperidol (Haloperidol) C Lithium Carbonate (Lithium Carbonate) C 22-Feb-2006 08:20 AM Page: 1151 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/01ISR Number: 3839773-5Report Type:Expedited (15-DaCompany Report #NSADSS2001037676 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diastolic Dysfunction Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Tegretol (Carbamazepine) C Date:12/14/01ISR Number: 3840205-1Report Type:Expedited (15-DaCompany Report #NSADSS2001037304 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:12/14/01ISR Number: 3840209-9Report Type:Expedited (15-DaCompany Report #NSADSS2001037753 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:12/14/01ISR Number: 3840494-3Report Type:Expedited (15-DaCompany Report #EMADSS2001007235 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Foreign Risperdal (Tablet) Consciousness Health (Risperidone) PS ORAL 1 MG, 1 IN 1 Drug Interaction Professional DAY (S), ORAL Salivary Hypersecretion Other Lioseral (Baclofen) SS ORAL 5 MG, 3 IN 1 DAY (S), ORAL Date:12/14/01ISR Number: 3840496-7Report Type:Expedited (15-DaCompany Report #EMADSS2001007230 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Mass Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Other Date:12/14/01ISR Number: 3840497-9Report Type:Expedited (15-DaCompany Report #APCDSS2001001441 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Risperdal Hospitalization - Phosphokinase Increased Health (Risperidone) PS ORAL ORAL Initial or Prolonged Hypercapnia Professional Biperiden Other Loss Of Consciousness Other Hydrochloride Required Pyrexia (Biperiden Intervention to Suicide Attempt Hydrochloride) C Prevent Permanent Bromazepam Impairment/Damage (Bromazepam) C 22-Feb-2006 08:20 AM Page: 1152 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/01ISR Number: 3840919-3Report Type:Expedited (15-DaCompany Report #EMADSS2001005243 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Depression Foreign Risperdal(Tablet)(Ri Other Merycism Health speridone) PS ORAL 8 MG, DAILY, Obsessive-Compulsive Professional ORAL Disorder Leponex(Clozapine) C Date:12/14/01ISR Number: 3840924-7Report Type:Expedited (15-DaCompany Report #EMADSS2001006675 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Distension Foreign Risperdal(4 Mg Initial or Prolonged Neurogenic Bladder Health Tablet)(Risperidone) PS ORAL 4 MG, ORAL; 5 Renal Failure Acute Professional MG, DAILY, Company ORAL; 6MG, Representative DAILY ORAL Zoloft(Sertraline Hydrochloride) C Xanax(Alprazolam) C Stediril(Eugynon) C Valsartan(Valsartan) C Date:12/14/01ISR Number: 3840930-2Report Type:Expedited (15-DaCompany Report #EMADSS2001007170 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertrophic Foreign Risperdal(2 Mg Cardiomyopathy Health Tablet)(Risperidone) PS ORAL 2 MG, DAILY, Professional ORAL Date:12/14/01ISR Number: 3840936-3Report Type:Expedited (15-DaCompany Report #EMADSS2001007262 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Date:12/14/01ISR Number: 3840943-0Report Type:Expedited (15-DaCompany Report #EMADSS2001007112 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Foreign Risperidone Somnolence Health (Unspecified) Professional (Risperidone) PS ORAL 500 MCG, DAILY, ORAL Haldol(Unspecified)( Haloperidol) SS ORAL 2 MG, DAILY, ORAL Loxapac(Loxapine Succinate) SS ORAL 15 MG, DAILY, ORAL Olanzapine(Olanzapin e) SS ORAL 2.5 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1153 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/01ISR Number: 3841612-3Report Type:Direct Company Report # Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Tenderness Risperidone PS Janssen ORAL 1MG TID ORAL Required Gynaecomastia Fluoxetine 20mg Eli Intervention to Lilly SS Eli Lilly ORAL 60MG QAM ORAL Prevent Permanent Maltrexone C Impairment/Damage Trazadone C Diphenhydramine C Quetiapine C Date:12/19/01ISR Number: 3842253-4Report Type:Expedited (15-DaCompany Report #EMADSS2001007320 Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Corneal Opacity Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY (S), ORAL 6 MON Date:12/19/01ISR Number: 3842340-0Report Type:Expedited (15-DaCompany Report #EMADSS2001007008 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arterial Bruit Foreign Risperdal (1 Mg Initial or Prolonged Atrioventricular Block Health Tablet) First Degree Professional (Risperidone) PS ORAL 1MG, 1 IN 1 Blood Pressure Diastolic DAY (S), ORAL Decreased Equanil Body Temperature (Meprobamate) SS ORAL 250 MG, 2 IN Increased 1 DAY (S), Bradycardia ORAL Electrocardiogram Lexomil (Bromazepam) SS ORAL 3 MG, 1 IN 1 Repolarisation DAY (S), ORAL Abnormality Aricept (Donepezil) C Headache Malaise Vomiting Date:12/19/01ISR Number: 3842439-9Report Type:Expedited (15-DaCompany Report #EMADSS2001007294 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Foreign Risperdal Hospitalization - Condition Aggravated Health (Unspecified) Initial or Prolonged Haemorrhagic Stroke Professional (Risperidone) PS ORAL 1.5 MG, DAILY, ORAL Digitoxin (Digitoxin) C Furosemid (Furosemide) C Captopril (Captopril) C Beloc-Zoc (Metoprolol Succinate) C Prothazin (Promethazine 22-Feb-2006 08:20 AM Page: 1154 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:12/19/01ISR Number: 3842449-1Report Type:Expedited (15-DaCompany Report #NSADSS2001037960 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:12/20/01ISR Number: 3843134-2Report Type:Expedited (15-DaCompany Report #NSADSS2001038378 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drowning Health Risperdal(Unspecifie Professional d) (Risperidone) PS ORAL ORAL Date:12/20/01ISR Number: 3843277-3Report Type:Direct Company Report # Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Depakote PS ORAL 500 MG PO QD Risperdal SS ORAL 1MG PO QD Valproic Acid Level 5% C Date:12/20/01ISR Number: 3843601-1Report Type:Expedited (15-DaCompany Report #PHBS2001CA12521 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Exelon Electrocardiogram Qt Health (Rivastigmine) Prolonged Professional Capsule PS ORAL ORAL Syncope Other Risperidone (Risperidone) SS Date:12/20/01ISR Number: 3843856-3Report Type:Expedited (15-DaCompany Report #NSADSS2001038259 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Health Risperdal Orthostatic Hypotension Professional (Unspecified) Syncope (Risperidone) PS ORAL 2 MG ORAL Effexor (Venlafaxine Hydrochloride) C Date:12/20/01ISR Number: 3852354-2Report Type:Periodic Company Report #NSADSS2001029533 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dry Skin Consumer Reminyl (Tablet) Pruritus (Galantamine) PS ORAL 4 MG, 2 IN 1 Rash DAY(S), ORAL Skin Disorder Risperdal (Risperidone) SS Niacin (Nicotinic 22-Feb-2006 08:20 AM Page: 1155 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acid) SS Haldol (Risperidone) C Date:12/24/01ISR Number: 3844404-4Report Type:Expedited (15-DaCompany Report #NSADSS2001038417 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Health Risperdal (4 Mg Professional Tablet) (Risperidone) PS ORAL 4 MG, 1 IN 1 DAY (S), ORAL Dextromethorphan (Dextromethorphan) SS Zoloft (Sertraline Hydrochloride) C Date:12/24/01ISR Number: 3844582-7Report Type:Expedited (15-DaCompany Report #EMADSS2001007341 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphonia Foreign Risperdal Initial or Prolonged Dysphagia Health (Risperidone) PS ORAL 0.5 MG, Medication Error Professional DAILY, ORAL; Oropharyngeal Spasm 1 MG, DAILY, Overdose ORAL Tongue Spasm Date:12/26/01ISR Number: 3844433-0Report Type:Expedited (15-DaCompany Report #A129394 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Zoloft Tablets PS Professional Risperidone SS Company Cough Syrup SS Representative Ecstasy SS Date:12/26/01ISR Number: 3844841-8Report Type:Direct Company Report # Age:3 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Risperdal PS Date:12/26/01ISR Number: 3844889-3Report Type:Direct Company Report # Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Risperidone PS Initial or Prolonged Date:12/26/01ISR Number: 3845014-5Report Type:Expedited (15-DaCompany Report #APCDSS2001001508 Age:16 YR Gender:Male I/FU:I Outcome PT Other Benign Neoplasm Of Scrotum Hydrocele 22-Feb-2006 08:20 AM Page: 1156 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Testicular Disorder Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal (Tablet) Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Dexamphetamine (Dexamphetamine) C Date:12/27/01ISR Number: 3845472-6Report Type:Direct Company Report #CTU 157832 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Risperidone PS Initial or Prolonged Dyskinesia Self-Injurious Ideation Speech Disorder Tongue Spasm Date:12/28/01ISR Number: 3846664-2Report Type:Expedited (15-DaCompany Report #EMADSS2001006754 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Foreign Risperdal Increased Health (Unspecified) Lipase Increased Professional (Risperidone) PS ORAL 3 MG, DAILY, ORAL Date:12/28/01ISR Number: 3846665-4Report Type:Expedited (15-DaCompany Report #EMADSS2001007555 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiogenic Shock Foreign Risperdal (1 Mg Loss Of Consciousness Health Tablet)(Risperidone) PS Professional Trinipatch(Glyceryl Trinitrate) C Date:12/28/01ISR Number: 3846667-8Report Type:Expedited (15-DaCompany Report #NSADSS2001038696 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Risperidone) PS Professional Date:12/31/01ISR Number: 3845964-XReport Type:Direct Company Report #CTU 157967 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Activity Lithium (300mg) PS ORAL 900MG/D PO Initial or Prolonged Drug Toxicity Risperidone (2mg) SS ORAL 2MG BID PO Dysarthria Propoxyphene C Swelling Toxicologic Test Abnormal 22-Feb-2006 08:20 AM Page: 1157 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/31/01ISR Number: 3846055-4Report Type:Direct Company Report #CTU 158052 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal .25mg Initial or Prolonged Loss Of Consciousness Professional Janssen PS Janssen ORAL .25MG HS ORAL Date:12/31/01ISR Number: 3846151-1Report Type:Direct Company Report #USP 54656 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Risperdal 0.5mg PS Jansson Pharm Requip 0.5mg (Ropinirole Hydrochloride) SS Smithkline Beecham Date:12/31/01ISR Number: 3846561-2Report Type:Expedited (15-DaCompany Report #APCDSS2001001522 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperidone (Tablet) Neuroleptic Malignant Health (Risperidone) PS ORAL MG, DAILY, Syndrome Professional ORAL Cisapride (Cisapride) C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Biperiden (Biperiden) C Sultopride Hydrochloride (Sultopride Hydrochloride) C Bifidobacterium (Bifidobacterium) C Date:12/31/01ISR Number: 3846563-6Report Type:Expedited (15-DaCompany Report #EMADSS2001007586 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Foreign Risperdal Other Post Procedural Health (Unspecified) Complication Professional (Risperidone) PS Date:12/31/01ISR Number: 3846564-8Report Type:Expedited (15-DaCompany Report #NSADSS2001038696 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Company Representative 22-Feb-2006 08:20 AM Page: 1158 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/31/01ISR Number: 3846929-4Report Type:Expedited (15-DaCompany Report #NSADSS2001038901 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:12/31/01ISR Number: 3846955-5Report Type:Expedited (15-DaCompany Report #EMADSS2001007501 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 2 MG, DAILY, Company ORAL; 4 MG, Representative DAILY ORAL ; 5 MG, DAILY, ORAL Date:01/02/02ISR Number: 3847882-XReport Type:Direct Company Report #CTU 158168 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Risperidone (1mg) PS ORAL 1MG BEDTIME PO Paxil (40mg) SS 40MG AM PO Date:01/02/02ISR Number: 3847884-3Report Type:Direct Company Report #CTU 158169 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Risperidone (2mg) PS ORAL 2MG TWICE A DAY PO Paxil (40mg) SS ORAL 40MG AM PO Date:01/03/02ISR Number: 3847883-1Report Type:Expedited (15-DaCompany Report #NSADSS2001039036 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Risperdal (Tablet) Initial or Prolonged Fall (Risperidone) PS ORAL 5 MG, 2 IN 1 Joint Stiffness DAY(S), ORAL Rectal Haemorrhage Paxil (Paroxetine Hydrochloride) C Lipitor (Atorvastatin) C Ecotrin (Acetylsalicylic Acid) C Isorbid (Isosorbide Dinitrate) C Metoprolol (Metoprolol) C 22-Feb-2006 08:20 AM Page: 1159 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/02ISR Number: 3847913-7Report Type:Expedited (15-DaCompany Report #A129394 Age:20 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Above Health Zoloft Tablets PS ORAL 50.00 MG Therapeutic Professional TOTAL: DAILY: Serotonin Syndrome ORAL Risperidone SS Cough Syrup SS Date:01/03/02ISR Number: 3847926-5Report Type:Expedited (15-DaCompany Report #APCDSS2001001382 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Risperdal (Tablet) Hospitalization - Increased Health (Risperidone) PS ORAL 0.5 MG , Initial or Prolonged Aspartate Professional DAILY, ORAL Aminotransferase Fluvoxamine Maleate Increased (Fluvoxamine Blood Alkaline Maleate) SS ORAL 50 MG DAILY Phosphatase Increased ORAL Blood Lactate Sennoside Dehydrogenase Increased (Sennosides) C Gamma-Glutamyltransferase Brotizolam Increased (Brotizolam) C Infection In An Immunocompromised Host Loss Of Consciousness Septic Shock Urinary Tract Infection Date:01/03/02ISR Number: 3847942-3Report Type:Expedited (15-DaCompany Report #EMADSS2001006354 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal (2 Mg Initial or Prolonged Study Tablet) Health (Risperidone) PS ORAL 2 MG, 2 IN 1 Professional DAILY, ORAL Seroquel (Seroquel) SS ORAL 100 MG, 2 IN 1 DAILY, ORAL Hypnorex (Lithium Carbonate) C Date:01/04/02ISR Number: 3849035-8Report Type:Expedited (15-DaCompany Report #EMADSS2001007702 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Risperdal Initial or Prolonged Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY (S), ORAL Calcium Carbimide (Calcium Carbimide) SS ORAL 2 ML, DAILY, ORAL Venlafaxine (Venlafaxine) SS ORAL 75 MG, DAILY, ORAL Clomethiazole 22-Feb-2006 08:20 AM Page: 1160 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clomethiazole) SS ORAL 192 MG, 1 IN 7 DAY (S), ORAL Date:01/04/02ISR Number: 3849229-1Report Type:Expedited (15-DaCompany Report #NSADSS2001039330 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, 2 IN DAILY, ORAL Date:01/09/02ISR Number: 3850972-9Report Type:Expedited (15-DaCompany Report #NSADSS2002000450 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:01/09/02ISR Number: 3850995-XReport Type:Expedited (15-DaCompany Report #NSADSS2001036620 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Cholelithiasis Health Risperdal (Tablet) Intervention to Cholestasis Professional (Risperidone) PS ORAL 7 MG, DAILY, Prevent Permanent Cough ORAL Impairment/Damage Dysphagia Jaundice Laryngeal Polyp Nausea Rectal Cancer Vomiting Date:01/10/02ISR Number: 3851391-1Report Type:Expedited (15-DaCompany Report #NSADSS2002000601 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Health Risperdal (0.5 Mg Increased Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 3 IN 1 DAY(S), ORAL Haloperidol (Haloperidol) C Depakote (Valproate Semisodium) C Plavix (Clopidogrel Sulfate) C Protonix (Pantoprazole) C 22-Feb-2006 08:20 AM Page: 1161 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/10/02ISR Number: 3851738-6Report Type:Expedited (15-DaCompany Report #EMADSS2001007586 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death No Adverse Drug Effect Foreign Risperdal Other Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Lamotrigine (Lamotrigine) C Date:01/11/02ISR Number: 3850913-4Report Type:Expedited (15-DaCompany Report #A0170847A Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Wellbutrin Sr PS Glaxo Wellcome ORAL 100MG Per day 9 DAY Initial or Prolonged Convulsion Zoloft SS ORAL 100MG Per day YR Inappropriate Risperdal SS ORAL 1MG Per day Antidiuretic Hormone Uniphyl C 400MG Per day Secretion Lipidil C Loss Of Consciousness Novasen C 325MG Per day Polydipsia Rivotril C ORAL .5MG Twice Respiratory Tract per day Infection Norvasc C 2.5MG Per day Kemadrin C Glaxo Wellcome Date:01/14/02ISR Number: 3852210-XReport Type:Expedited (15-DaCompany Report #NSADSS2002000489 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Topamax (Topiramate) PS ORAL 300 MG, Initial or Prolonged Syndrome Study DAILY, ORAL Pneumonia Health Risperidone Respiratory Failure Professional (Risperidone) SS ORAL 8 MG, DAILY, ORAL Lorazepam (Lorazepam) SS ORAL 4 MG, DAILY, ORAL Date:01/14/02ISR Number: 3852767-9Report Type:Direct Company Report #CTU 159094 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Risperdal PS ORAL 1MG BID PO Required Syndrome Intervention to Prevent Permanent Impairment/Damage Date:01/16/02ISR Number: 3853568-8Report Type:Direct Company Report #CTU 159235 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eyelid Function Disorder Risperidone Hyperhidrosis Concentrate PS ORAL 0.5ML PO BID Muscle Rigidity Nystatin Elixir C Muscle Twitching Percocet C Oxycontin C Levoquin C 22-Feb-2006 08:20 AM Page: 1162 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Synthroid C Cacl3 C Feso4 C Mvi C Xalatan C Timoptic C Date:01/16/02ISR Number: 3853573-1Report Type:Direct Company Report #CTU 159240 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Skin Hyperpigmentation Risperidone (3mg) PS ORAL 3MG PO TID Lorazepam C Benztropine C Prolixin Dec C Risperidone C Date:01/16/02ISR Number: 3853902-9Report Type:Expedited (15-DaCompany Report #NSADSS2002000882 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:01/16/02ISR Number: 3854068-1Report Type:Expedited (15-DaCompany Report #EMADSS2002000084 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Risperdal Congenital Anomaly Health (Unspecified) Maternal Drugs Affecting Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 Foetus DAY(S), ORAL Sertraline (Sertraline) SS ORAL 50 MG, DAILY, ORAL Salbutamol (Salbutamol) C Beclomethasone (Beclometasone) C Date:01/16/02ISR Number: 3854069-3Report Type:Expedited (15-DaCompany Report #APCDSS2002000019 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Urinary Incontinence Foreign Risperdal Hospitalization - Health (Unspecified) Initial or Prolonged Professional (Risperidone) PS ORAL 2 MG, 2 IN 1 Company DAILY, ORAL Representative 22-Feb-2006 08:20 AM Page: 1163 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/17/02ISR Number: 3854201-1Report Type:Expedited (15-DaCompany Report #EMADSS2001007555 Age:93 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiogenic Shock Foreign Risperdal (1 Mg Loss Of Consciousness Health Tablet) Professional (Risperidone) PS Trinipatch (Glyceryl Trinitrate) C Date:01/17/02ISR Number: 3854779-8Report Type:Expedited (15-DaCompany Report #NSADSS2002001298 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Risperdal (3mg Professional Tablet) (Risperidone) PS ORAL ORAL Date:01/17/02ISR Number: 3854929-3Report Type:Expedited (15-DaCompany Report #NSADSS2002001283 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:01/17/02ISR Number: 3854957-8Report Type:Expedited (15-DaCompany Report #NSADSS2002001295 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:01/17/02ISR Number: 3855024-XReport Type:Expedited (15-DaCompany Report #NSADSS2002001290 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:01/17/02ISR Number: 3855027-5Report Type:Expedited (15-DaCompany Report #NSADSS2002001451 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Chronic Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 1164 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/17/02ISR Number: 3855063-9Report Type:Expedited (15-DaCompany Report #NSADSS2002001289 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:01/17/02ISR Number: 3855661-2Report Type:Direct Company Report #CTU 159546 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Risperidone PS ORAL 1 TABLET BY MOUTH 2 TIMES PER DAY Sotalol C Prednisone C Albuterol Soln. C Ipratropium C Acetaminophen C Ibuprofen C Date:01/22/02ISR Number: 3857813-4Report Type:Expedited (15-DaCompany Report #NSADSS2001033536 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Risperdal Other Oculogyration Health (Unspecified) Systemic Lupus Professional (Risperidone) PS ORAL 3, DAILY, Erythematosus ORAL 4, DAILY, ORAL Kemadrin (Procyclidine Hydrochloride) C Tricyclen (Tricyclen (Norgestimate/Ethiny lestradiol) C Date:01/22/02ISR Number: 3857815-8Report Type:Expedited (15-DaCompany Report #EMADSS2001007377 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Systolic Foreign Risperdal (0.5 Mg Increased Health Tablet) Coma Professional (Risperidone) PS TEMPORARY Eye Rolling STOP 18 - Hypotension 24-NOV-01 Shock Captohexal (Captopril) C Date:01/22/02ISR Number: 3858208-XReport Type:Expedited (15-DaCompany Report #NSADSS2002001612 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Heat Stroke Consumer Risperdal (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1165 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/02ISR Number: 3858225-XReport Type:Expedited (15-DaCompany Report #NSADSS2002001652 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Risperdal Decreased Literature (Unspecified) White Blood Cell Count Health (Risperidone) PS ORAL 1 MG, DAILY, Decreased Professional ORAL Date:01/22/02ISR Number: 3858303-5Report Type:Expedited (15-DaCompany Report #NSADSS2002001621 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:01/22/02ISR Number: 3858334-5Report Type:Expedited (15-DaCompany Report #PHEH2002US00689 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Study Exelon Disorientation Health (Rivastigmine) Drug Interaction Professional Unknown PS ORAL 1.5 MG, BID, Tremor ORAL 3MG, BID, ORAL Risperdal (Risperidone) SS Digoxin C Levothroid C Nolvadex C Aciphex (Rabeprazole Sodium) C Date:01/22/02ISR Number: 3858660-XReport Type:Expedited (15-DaCompany Report #NSADSS2002001606 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:01/22/02ISR Number: 3858786-0Report Type:Expedited (15-DaCompany Report #NSADSS2001036106 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Risperdal (2 Mg Initial or Prolonged Deep Vein Thrombosis Health Tablet) Diarrhoea Professional (Risperidone) PS ORAL 2 MG, 1 IN 24 Plantar Fasciitis HOUR (S), Protein S Deficiency ORAL Thrombosis Clonopin (Clonazepam) C Provigil (Modafinil) C Coumadin (Warfarin Sodium) C Paxil (Paroxetine Hydrochloride) C Viagra (Sildenafil) C 22-Feb-2006 08:20 AM Page: 1166 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Enterocoated Aspirin (Acetylsalicylic Acid) C Date:01/22/02ISR Number: 3858788-4Report Type:Expedited (15-DaCompany Report #NSADSS2001017866 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAILY, ORAL Nitroglycerin (Glyceryl Trinitrate) C Pepcid (Famotidine) C Tenormin (Atenolol) C Lanoxin (Digoxin) C Date:01/23/02ISR Number: 3857823-7Report Type:Expedited (15-DaCompany Report #APCDSS2002000019 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Urinary Incontinence Foreign Risperdal Hospitalization - Health (Unspecified) Initial or Prolonged Professional (Risperidone) PS ORAL MG,D AILY, Company ORAL Representative Date:01/23/02ISR Number: 3859249-9Report Type:Expedited (15-DaCompany Report #2002088857FR Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiopulmonary Failure Foreign Xanax (Alprazolam) Pyrexia Health Tablet PS ORAL 0.375 MG/DAY, Professional ORAL Other Solu-Medrol (Methylprednisolone) Powder, Sterile SS INTRAVENOUS 200-MG/DAY, IV Seropram (Citalopram Hydrobromide) SS Risperdal (Risperidone) 1 Mg SS ORAL 1-MG/DAY, ORAL Date:01/23/02ISR Number: 3859770-3Report Type:Periodic Company Report #NSADSS2001024060 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Consumer Risperdal (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1167 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3859772-7Report Type:Periodic Company Report #NSADSS2001024067 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Risperdal (4 Mg Initial or Prolonged Coma Professional Tablet) Drug Effect Increased (Risperidone) PS ORAL 4 MG, 1 IN 1 Somnolence DAY (S), ORAL Speech Disorder Metoprolol Tremor (Metoprolol) C Visual Disturbance Albuterol Vomiting (Salbutamol) C Zocor (Simvastatin) C Prinivil (Lisinopril) C Glyburide (Glibenclamide) C Date:01/23/02ISR Number: 3859773-9Report Type:Periodic Company Report #NSADSS2001025492 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Stomatitis Health Risperdal Tardive Dyskinesia Professional (Unspecified) (Risperidoone) PS ORAL ORAL Date:01/23/02ISR Number: 3859774-0Report Type:Periodic Company Report #NSADSS2001025734 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal (2 Mg Electrocardiogram Qt Professional Tablet) Prolonged (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY (S), ORAL Date:01/23/02ISR Number: 3859775-2Report Type:Periodic Company Report #NSADSS2001026022 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Effexor (Venlafaxine Hydrochloride) C Date:01/23/02ISR Number: 3859776-4Report Type:Periodic Company Report #NSADSS2001026194 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Dreams Consumer Risperdal (.25 Mg Initial or Prolonged Angina Pectoris Tablet) Anorexia (Risperidone) PS ORAL 0.25 MG, 2 IN Dry Mouth 1 DAY (S), Fatigue ORAL Hypertonia Depakote (Valproate Salivary Hypersecretion Semisodium) C Plavix (Clopidogrel Sulfate) C 22-Feb-2006 08:20 AM Page: 1168 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lopressor (Metoprolol Tartrate) C Isordil (Isosorbide Dinitrate) C Asa (Acetylsalicylic Acid) C Lasix (Furosemide) C Vitamin E (Tocopherol) C Iron Gluconate (Iron Preparations) C Ranitidine (Ranitidine) C Nitroglycerin (Glyceryl Trinitrate) C Date:01/23/02ISR Number: 3859777-6Report Type:Periodic Company Report #NSADSS2001026642 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Risperdal (4 Mg Initial or Prolonged Professional Tablet) (Risperidone) PS ORAL 12 MG, 1 IN 1 DAY (S), ORAL Date:01/23/02ISR Number: 3859778-8Report Type:Periodic Company Report #NSADSS2001026712 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperdal(Risperidon Initial or Prolonged Myocardial Infarction Professional e) PS Neuroleptic Malignant Prevacid Syndrome (Lansoprazole) C Orthostatic Hypotension Glyburide (Glibenclamide) C Ferrous Sulfate (Ferrous Sulfate) C Date:01/23/02ISR Number: 3859780-6Report Type:Periodic Company Report #NSADSS2001027756 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Attention Health Risperdal Deficit/Hyperactivity Professional (Unspecified) Disorder (Risperidone) PS ORAL 1 MG, 1 IN 1 Tardive Dyskinesia NIGHT (S), ORAL Coumadin (Warfarin Sodium) C Lanoxin (Digoxin) C 22-Feb-2006 08:20 AM Page: 1169 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3859781-8Report Type:Periodic Company Report #NSADSS2001027936 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Consumer Risperdal (0.5 Mg Dyskinesia Tablet) Tardive Dyskinesia (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY (S), ORAL; 1 MG, 1 DAY (S), ORAL Cogentin (Benzatropine Mesilate) C Zoloft (Sertraline Hydrochloride) C Prednisone (Prednisone) C Date:01/23/02ISR Number: 3859782-XReport Type:Periodic Company Report #NSADSS2001028131 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal (4 Mg Professional Tablet) (Risperidone) PS ORAL 4 MG, 1 IN 1 DAY (S), ORAL Ritalin (Methylphenidate Hydrochloride) C Adderall (Obetrol) C Date:01/23/02ISR Number: 3859783-1Report Type:Periodic Company Report #NSADSS2000002235 Age:98 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Consumer Risperdal (Tablet) Initial or Prolonged Injury (Risperidone) PS ORAL SEE IMAGE Nightmare Trazodone Tardive Dyskinesia (Trazodone) C Aricept (Donepezil Hydrochloride) C Date:01/23/02ISR Number: 3859784-3Report Type:Periodic Company Report #NSADSS2000003065 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Risperdal ( 1mg Professional Tablet) (Risperidone) PS ORAL 2 MG, 2 IN 1, ORAL Hydrocodone (Hydrocodone) SS Apap(Paracetamol) SS 22-Feb-2006 08:20 AM Page: 1170 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3859785-5Report Type:Periodic Company Report #NSADSS2000003326 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Risperdal Initial or Prolonged Catatonia (Risperidone) PS ORAL ORAL Oculogyration Topamax (Tablet) Speech Disorder (Topiramate) SS ORAL ORAL 6 MON Weight Decreased Topamax (Tablet) (Topiramate) SS Date:01/23/02ISR Number: 3859786-7Report Type:Periodic Company Report #NSADSS2001000359 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Risperdal (Tablet) Initial or Prolonged Somnolence (Risperidone) PS ORAL ORAL Suicide Attempt Phenobarbitol (Phenobarbital) SS ORAL ORAL Tegretol (Carbamazepine) C Date:01/23/02ISR Number: 3859789-2Report Type:Periodic Company Report #NSADSS2001000851 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Consumer Risperdal (Tablet) Initial or Prolonged Hypotension (Risperidone) PS ORAL 3 MG , DAILY, Required Hypothermia ORAL Intervention to Pneumonitis Benadryl Prevent Permanent Salivary Hypersecretion (Diphenhydramine Impairment/Damage Somnolence Hydrochloride C Date:01/23/02ISR Number: 3859790-9Report Type:Periodic Company Report #NSADSS2001001740 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Tardive Dyskinesia Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:01/23/02ISR Number: 3859792-2Report Type:Periodic Company Report #NSADSS2001002131 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Consumer Risperdal Initial or Prolonged Weight Increased (Unspecified) (Risperidone) PS ORAL 0.5 MG, 3 IN 1 DAY(S), ORAL Ritalin (Methylphenidate Hydrochloride) SS ORAL ORAL Ddavp (Desmopressin) C Zoloft (Sertraline Hydrochloride) C Buspar (Buspirone Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1171 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3859793-4Report Type:Periodic Company Report #NSADSS2001002171 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Consumer Risperdal (2 Mg Initial or Prolonged Speech Disorder Tablet) (Risperidone) PS ORAL 2MG, 4 IN 1 DAY(S), ORAL Neurontin (Gabapentin) C Ambien (Zolpidem Tartrate) C Date:01/23/02ISR Number: 3859794-6Report Type:Periodic Company Report #NSADSS2001002643 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Risperdal (3 Mg Initial or Prolonged Professional Tablet) Required (Risperidone) PS ORAL 3MG, 1 IN 1 Intervention to DAY(S), ORAL Prevent Permanent Impairment/Damage Date:01/23/02ISR Number: 3859795-8Report Type:Periodic Company Report #NSADSS2001002800 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (Tablet) Initial or Prolonged Dizziness (Risperidone) PS ORAL ORAL Somnolence Clozapine (Clozapine) C Vistaril (Hydroxyzine Embonate) C Ambien (Zolpidem Tartrate) C Date:01/23/02ISR Number: 3859796-XReport Type:Periodic Company Report #NSADSS2001003095 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Risperdal (Tablet) Initial or Prolonged Confusional State Professional (Risperidone) PS ORAL 0.5 MG, 1 IN Disturbance In Attention Company 1 DAY(S), Extrapyramidal Disorder Representative ORAL : 1.5 Infection MG DAILY ORAL Mania Eskalith (Lithium Carbonate) SS ORAL 450 MG, 2 IN 1 DAY(S), ORAL Neurontin (Gabapentin) C Paxil (Paroxetine Hydrochloride) C Premarin (Estrogens Conjugated) C Detrol (Tolterodine L-Tartrate) C 22-Feb-2006 08:20 AM Page: 1172 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam (Lorazepam) C Date:01/23/02ISR Number: 3859797-1Report Type:Periodic Company Report #NSADSS2001003357 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myalgia Consumer Risperdal (3 Mg Initial or Prolonged Suicide Attempt Tablet) (Risperidone) PS ORAL 3 MG, 2 IN 1 DAY(S), ORAL Zoloft (Sertraline Hydrochloride) C Ativan (Lorazepam) C Date:01/23/02ISR Number: 3859799-5Report Type:Periodic Company Report #NSADSS2001003593 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal (.25 Mg Initial or Prolonged Drug Effect Increased Tablet) (Risperidone) PS ORAL .25 MG, 2 IN 1 DAY(S), ORAL : 1 MG , 1 IN 1 DAY(S) ORAL Date:01/23/02ISR Number: 3859800-9Report Type:Periodic Company Report #NSADSS2001004992 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Consumer Risperdal (0.5 Mg Initial or Prolonged Hypertension Health Tablet) Weight Increased Professional (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAILY,ORAL Micardis (Telmisartan) C Allegra (Fexofenadine Hydrochloride) C Date:01/23/02ISR Number: 3859801-0Report Type:Periodic Company Report #NSADSS2001005257 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Health Risperdal Initial or Prolonged Professional (Unspecified) (Risperidone) PS ORAL 3 MG, 1 IN 1 DAY(S),ORAL Lotral (Lotrel) C Tylenol (Paracetamol) C 22-Feb-2006 08:20 AM Page: 1173 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3859802-2Report Type:Periodic Company Report #NSADSS2001005427 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Risperdal (3 Mg Hospitalization - Neuroleptic Malignant Professional Tablet) Initial or Prolonged Syndrome (Risperidone) PS ORAL 3 MG, 1 IN 1 DAY(S) ,ORAL Doxepin (Doxepin) C Dyazide (Dyazide) C Colace (Docusate Sodium) C Metamucil (Psyllium Hydrophilic Mucilloid) C Date:01/23/02ISR Number: 3859803-4Report Type:Periodic Company Report #NSADSS2001005758 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S) ORAL Date:01/23/02ISR Number: 3859804-6Report Type:Periodic Company Report #NSADSS2001006922 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pituitary Tumour Consumer Risperdal Initial or Prolonged (Unspecified) (Risperidone) PS ORAL ORAL Date:01/23/02ISR Number: 3859805-8Report Type:Periodic Company Report #NSADSS2001007597 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Risperdal (Tablet) Initial or Prolonged Psychotic Disorder (Risperidone) PS ORAL 4 MG, 1 IN 1 Urinary Incontinence DAY(S) ORAL : 2 MG, 1 IN 1 DAY(S) ORAL Lanoxin (Digoxin) C Date:01/23/02ISR Number: 3859806-XReport Type:Periodic Company Report #NSADSS2001008090 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Consumer Risperdal (1 Mg Tablet) (Risperidone) PS ORAL 6 MG, 1 IN 1 DAY(S) ORAL : 10 MG, 1 IN 1 DAY(S) ORAL 22-Feb-2006 08:20 AM Page: 1174 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3859807-1Report Type:Periodic Company Report #JRFUSA2000006568 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Risperdal Initial or Prolonged Professional (Unspecified) Company (Risperidone) PS 3-4 WEEKS Representative DURATION Date:01/23/02ISR Number: 3859808-3Report Type:Periodic Company Report #NSADSS2001032430 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Risperdal (1 Mg Initial or Prolonged Tablet) (Risperidone) PS ORAL 1 MG, 2 IN 24 HOUR (S), ORAL Effexor (Venlafaxine Hydrochloride) C Date:01/23/02ISR Number: 3859810-1Report Type:Periodic Company Report #NSADSS2001032736 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Risperdal (Tablet) Initial or Prolonged Condition Aggravated (Risperidone) PS ORAL 5 MG, DAILY, Dyspnoea ORAL Erectile Dysfunction Trilafon Tongue Oedema (Perphenazine) C Lithium (Lithium) C Ativan (Lorazepam) C Date:01/23/02ISR Number: 3859812-5Report Type:Periodic Company Report #NSADSS2001032797 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypernatraemia Health Risperdal (0.5 Mg Somnolence Professional Tablet) Stupor (Risperidone) PS ORAL 0.5 MG, 2 IN DAILY, ORAL Prescription Medication C Date:01/23/02ISR Number: 3859814-9Report Type:Periodic Company Report #NSADSS2001032859 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Priapism Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 6 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1175 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3859816-2Report Type:Periodic Company Report #NSADSS2001032889 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Consumer Risperdal (4 Mg Initial or Prolonged Hypertonia Tablet) Required Pneumonia (Risperidone) PS ORAL 4 MG, 2 IN 1 Intervention to Tremor DAY (S), ORAL Prevent Permanent Ativan (Lorazepam) C Impairment/Damage Date:01/23/02ISR Number: 3859817-4Report Type:Periodic Company Report #NSADSS2001033311 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Risperdal (0.5 Mg Initial or Prolonged Professional Tablet) PS ORAL 0.5 MG, 1 IN 1 DAY (S), ORAL Effexor (Venlfaxine Hydrochloride) C Date:01/23/02ISR Number: 3859818-6Report Type:Periodic Company Report #NSADSS2001033561 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal (Tablet) Fatigue Professional (Risperidone) PS ORAL 5 MG, 1 IN 1 Nervousness DAY (S), ORAL Weight Increased Norpromin (Desiprmine Hydrochloride) C Date:01/23/02ISR Number: 3859819-8Report Type:Periodic Company Report #NSADSS2001033990 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, 2 IN DAILY, ORAL Date:01/23/02ISR Number: 3859820-4Report Type:Periodic Company Report #NSADSS2001035605 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Increased Consumer Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Fluroxamine (Fluvoxamine) C Norvasc (Amlodipine Besilate) C Asa (Acetylsalicylic Acid) C 22-Feb-2006 08:20 AM Page: 1176 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3859821-6Report Type:Periodic Company Report #NSADSS2001036613 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Unspecified) (Risperidone) PS Date:01/23/02ISR Number: 3859829-0Report Type:Periodic Company Report #NSADSS2001012897 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Health Risperdal (1 Mg Initial or Prolonged Professional Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Hydrochlorothiazide (Hydrochlorothiazide ) C Dalmane (Flurazepam Hydrochloride) C Atenolol (Atenolol) C Date:01/23/02ISR Number: 3859830-7Report Type:Periodic Company Report #NSADSS2001013191 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Health Risperdal (2 Mg Initial or Prolonged Hypotension Professional Tablet) Somnolence (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY(S), ORAL Thorazine (Chlorpromazine Hydrochloride) C Carbamazepine (Carbamazepine) C Date:01/23/02ISR Number: 3859831-9Report Type:Periodic Company Report #NSADSS2001013196 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Risperdal (Tablet) Initial or Prolonged (Risperidone) PS ORAL SEE IMAGE Baycol (Cerivastatin Sodium) C Phenobarbital (Phenobarbital) C Tegretol (Carbamazepine) C Date:01/23/02ISR Number: 3859832-0Report Type:Periodic Company Report #NSADSS2001013209 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Risperdal (Tablet) Hospitalization - Syndrome Professional Risperidone PS ORAL ORAL Initial or Prolonged Sudden Death Paxil (Paroxetine Hydrochloride) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1177 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haldol (Tablet) (Haloperidol) C Date:01/23/02ISR Number: 3859834-4Report Type:Periodic Company Report #NSADSS2001013710 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal (2 Mg Tardive Dyskinesia Professional Tablet) (Risperidone) PS ORAL 2 MG, 1 IN 1 DAY(S), ORAL Date:01/23/02ISR Number: 3859835-6Report Type:Periodic Company Report #NSADSS2001013755 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Health Risperdal (1 Mg Initial or Prolonged Deficit/Hyperactivity Professional Tablet) Disorder (Risperidone) PS ORAL 1 MG, 2 IN DAILY, ORAL Date:01/23/02ISR Number: 3859836-8Report Type:Periodic Company Report #NSADSS2001014108 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Consumer Risperdal (2 Mg Tablet) (Risperidone) PS ORAL 2 MG, 1 IN 1 DAY(S), ORAL Prozac (Fluoxetine Hydrochloride) SS ORAL ORAL Wellbutrin (Amfebutamone Hydrochloride) SS ORAL ORAL Date:01/23/02ISR Number: 3859837-XReport Type:Periodic Company Report #NSADSS2001014220 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, 1 IN 1 TIME(S), ORAL Ativan (Lorazepam) C Date:01/23/02ISR Number: 3859838-1Report Type:Periodic Company Report #NSADSS2001014333 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (1 Mg Initial or Prolonged Hepatitis Professional Tablet) (Risperidone) PS ORAL 1 MG, 3 IN 1 DAY(S), ORAL Celexa (Citalopram Hydrobromide) C 22-Feb-2006 08:20 AM Page: 1178 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3859839-3Report Type:Periodic Company Report #NSADSS2001014823 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Risperdal (Tablet) Muscle Contractions (Risperidone) PS ORAL ORAL Involuntary Dilantin (Phenytoin Sodium) C Phenobarbital (Phenobarbital) C Topamax (Tablet) (Topiramate) C Estrogens (Estrogens) C Baycol (Cerivastatin Sodium) C Hydrochlorothiazide (Hydrochlorothiazide ) C Date:01/23/02ISR Number: 3859840-XReport Type:Periodic Company Report #NSADSS2001008093 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Consumer Risperdal ( 1 Mg Initial or Prolonged Hypertonia Tablet) Muscle Contractions (Risperidone) PS ORAL 1 MG, 2 IN 1 Involuntary DAY(S), ORAL Date:01/23/02ISR Number: 3859841-1Report Type:Periodic Company Report #NSADSS2001008332 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Risperdal ( 1mg Talbet) (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY (S), ORAL Divalproex (Valproate Semisodium) C Date:01/23/02ISR Number: 3859842-3Report Type:Periodic Company Report #NSADSS2001008619 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal (Tablet) Initial or Prolonged Agitation (Risperidone) PS ORAL 2 MG, 1 IN 1 Condition Aggravated DAY, ORAL; Mania SEE IMAGE Trileptal (Oxcarbazepine) C Depakote (Valproate Semisodium) C 22-Feb-2006 08:20 AM Page: 1179 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3859843-5Report Type:Periodic Company Report #NSADSS2001008785 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal (3 Mg Professional Tablet ) (Risperidone) PS ORAL 3 MG, 1 IN 1 HOUR(S)M, ORAL Date:01/23/02ISR Number: 3859845-9Report Type:Periodic Company Report #NSADSS2001009237 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Phlebitis Health Risperdal (1 Mg Pulmonary Embolism Professional Tablet) (Risperidone) PS ORAL 1MG , 1 IN 1 DAY(S), ORAL Birth Control Pills (Oral Contraceptive Nos) C Date:01/23/02ISR Number: 3859846-0Report Type:Periodic Company Report #NSADSS2001009887 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Risperdal (0.5 Mg Initial or Prolonged Professional Talbet) (Risperidone) PS ORAL 0.5 MG , 1 IN 1 DAY (S), ORAL Celexa (Citalopram Hydrobromide) C Date:01/23/02ISR Number: 3859847-2Report Type:Periodic Company Report #NSADSS2001009924 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Health Risperdal Initial or Prolonged Rash Professional (Unspecified) (Resperidone) PS Ativan (Lorazepam) C Trilafon (Perphenazine) C Date:01/23/02ISR Number: 3859849-6Report Type:Periodic Company Report #NSADSS2001010216 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Consumer Risperdal (Tablet) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1180 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3859850-2Report Type:Periodic Company Report #NSADSS2001010817 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (2 Mg Initial or Prolonged Health Tablet) Professional (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY(S), ORAL Stelazine (Trifluoperazine Hydrochloride) C Date:01/23/02ISR Number: 3859853-8Report Type:Periodic Company Report #NSADSS2001011770 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Risperdal (Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL 1.5 MG, 2 IN 1 DAY(S), ORAL Cogentin (Benzatropine Mesilate) C Date:01/23/02ISR Number: 3859904-0Report Type:Periodic Company Report #NSADSS2001014875 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Galactorrhoea Consumer Risperdal (Tablet) Initial or Prolonged Hyperprolactinaemia (Risperidone) PS ORAL SEE IMAGE Date:01/23/02ISR Number: 3859905-2Report Type:Periodic Company Report #NSADSS2001015443 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:01/23/02ISR Number: 3859906-4Report Type:Periodic Company Report #NSADSS2001016443 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal (Tablet) Initial or Prolonged Syndrome Professional (Risperidone) PS ORAL 4 MG, 1 DAY(S), ORAL Zoloft (Sertraline Hydrochloride) C Lithobid (Lithium Carbonate) C Valium (Diazepam) C 22-Feb-2006 08:20 AM Page: 1181 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3859907-6Report Type:Periodic Company Report #NSADSS2001016651 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (4 Mg Initial or Prolonged Weight Increased Tablet) (Risperidone) PS ORAL SEE IMAGE Date:01/23/02ISR Number: 3859909-XReport Type:Periodic Company Report #NSADSS2001016843 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accommodation Disorder Consumer Risperdal (Tablet) Initial or Prolonged Drug Effect Increased Health (Risperidone) PS ORAL ORAL Stupor Professional Date:01/23/02ISR Number: 3859911-8Report Type:Periodic Company Report #NSADSS2001016922 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (3 Mg Initial or Prolonged Suicide Attempt Tablet) (Risperidone) PS ORAL SEE IMAGE Date:01/23/02ISR Number: 3859912-XReport Type:Periodic Company Report #NSADSS2001016930 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Vomiting Consumer Risperdal (0.5 Mg Initial or Prolonged Weight Increased Tablet) (Risperidone) PS ORAL 0.5 MG, 2 DAILY, ORAL Zoloft (Sertraline Hydrochloride) SS ORAL ORAL Date:01/23/02ISR Number: 3859914-3Report Type:Periodic Company Report #NSADSS2001017871 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Risperidal Initial or Prolonged Pyrexia Professional (Risperidone) PS ORAL 6, DAILY, Vomiting ORAL Trazodone (Trazodone) C Date:01/23/02ISR Number: 3859917-9Report Type:Periodic Company Report #NSADSS2001017912 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Risperdal (2 Mg Initial or Prolonged Rash Maculo-Papular Professional Tablet) (Risperidone) PS ORAL SEE IMAGE 22-Feb-2006 08:20 AM Page: 1182 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3859918-0Report Type:Periodic Company Report #NSADSS2001017949 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 7 MG, DAILY, ORAL Dilantin (Phenytoin Sodium) C Lamictal (Lamotrigine) C Neurontin (Gabapentin) C Date:01/23/02ISR Number: 3859920-9Report Type:Periodic Company Report #NSADSS2001019000 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Risperdal Initial or Prolonged Professional (Unspecified) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Pepcid (Famotidine) C Prozac (Fluoxetine Hydrochloride) C Lopid (Gemfibrozil) C Heparin (Heparin) C Singulair (Montelukast Sodium) C Prilosec (Omeprazole) C Tylenol (Paracetamol) C Hydromorphone (Hydromorphone) C Lorazepam (Lorazepam) C Demerol (Pethidine Hydrochloride) C Promethazine (Promethazine) C Serevent (Salmeterol Xinafoate) C Date:01/23/02ISR Number: 3859922-2Report Type:Periodic Company Report #NSADSS2001019006 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL 2 MG, 1 IN 1 NIGHT(S), ORAL Ativan (Lorazepam) C Ambien (Zolpidem Tartrate) C Celexa (Citalopram Hydrobromide) C 22-Feb-2006 08:20 AM Page: 1183 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3859923-4Report Type:Periodic Company Report #NSADSS2001019886 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Consumer Risperdal Anxiety (Unspecified) Suicide Attempt (Risperidone) PS ORAL 2 MG, DAILY, ORAL Date:01/23/02ISR Number: 3859930-1Report Type:Periodic Company Report #NSADSS2001020331 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 12 MG, 1 IN 1 DAY(S), ORAL Gabapentin (Gabapentin) SS Lithium (Lithium) C Date:01/23/02ISR Number: 3859931-3Report Type:Periodic Company Report #NSADSS2001020632 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal(1 Mg Professional Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 1 NIGHT(S), ORAL Tegretol (Carbamazepine) C Clonidine (Clonidine) C Date:01/23/02ISR Number: 3859933-7Report Type:Periodic Company Report #NSADSS2001022038 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Consumer Risperdal (2 Mg Tablet) (Risperidone) PS ORAL 2 MG, 4 IN 1 DAY(S), ORAL Prevacid (Lansoprazole) C Efrane (Enflurane) C Levoxyl (Levothyroxine Sodium) C Furosemide (Furosemide) C Date:01/23/02ISR Number: 3859934-9Report Type:Periodic Company Report #NSADSS2001022653 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Death Condition Aggravated Health Hospitalization - Sudden Death Professional Initial or Prolonged Company 22-Feb-2006 08:20 AM Page: 1184 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Risperdal (1 Mg Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Trazodone (Trazodone) C Klonopin (Clonazepam) C Paxil (Paroxetine Hydrochloride) C Date:01/23/02ISR Number: 3859936-2Report Type:Periodic Company Report #NSADSS2001023770 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:01/23/02ISR Number: 3859937-4Report Type:Periodic Company Report #NSADSS2001023905 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ketosis Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:01/23/02ISR Number: 3859939-8Report Type:Periodic Company Report #NSADSS2001023927 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperdal (0.5 Mg Initial or Prolonged Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 3 IN 1 DAY(S). ORAL Zyprexa (Olanzapine) C Date:01/23/02ISR Number: 3859940-4Report Type:Periodic Company Report #NSADSS2001028618 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Professional (Risperidone) PS Date:01/23/02ISR Number: 3859941-6Report Type:Periodic Company Report #NSADSS2001029161 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL DAILY, ORAL Olanzapine (Olanzapine) SS ORAL DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1185 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Perphenazine (Perphenazine) SS ORAL DAILY, ORAL Date:01/23/02ISR Number: 3859942-8Report Type:Periodic Company Report #NSADSS2001030014 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN 1 NIGHT(S), ORAL Effexor Xr (Venlafaxine Hydrochloride) SS ORAL 300 MG, DAILY, ORAL Lithium Carbonate (Lithium Carbonate) C Date:01/23/02ISR Number: 3859943-XReport Type:Periodic Company Report #NSADSS2001030207 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Health Risperdal (1 Mg Initial or Prolonged Professional Tablet) (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY(S), ORAL Fluphenazine (Fluphenazine) C Albuterol (Salbutamol) C Trazodone (Trazodone) C Benztropine Mesylate (Benzatropine Mesilate) C Date:01/23/02ISR Number: 3859945-3Report Type:Periodic Company Report #NSADSS2001030429 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperidone Initial or Prolonged (Risperidone) PS Zyprexa (Olanzapine) SS Date:01/23/02ISR Number: 3859947-7Report Type:Periodic Company Report #NSADSS2001030885 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (Tablet) Initial or Prolonged Diabetes Mellitus Professional (Risperidone) PS ORAL ORAL Weight Increased 22-Feb-2006 08:20 AM Page: 1186 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/02ISR Number: 3859949-0Report Type:Periodic Company Report #NSADSS2001030927 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperdal (0.5 Mg Initial or Prolonged Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Paxil (Paroxetine Hydrochloride) C Lithium (Lithium) C Date:01/23/02ISR Number: 3859951-9Report Type:Periodic Company Report #NSADSS2001031223 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperdal (Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL 6 MG, ORAL Company Wellbutrin Representative (Amfebutamone Hydrochloride) C Lithium (Lithium) C Date:01/23/02ISR Number: 3859953-2Report Type:Periodic Company Report #NSADSS2001031506 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Health Risperdal Initial or Prolonged Deficit/Hyperactivity Professional (Risperidone) PS ORAL 0.5 MG, 2 IN Disorder DAILY, ORAL Condition Aggravated Prozac (Fluoxetine Gait Disturbance Hydrochloride) C Hypertonia Cogentin Somnolence (Benzatropine Mesilate) C Date:01/23/02ISR Number: 3859957-XReport Type:Periodic Company Report #NSADSS2001031773 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:01/24/02ISR Number: 3858924-XReport Type:Direct Company Report #CTU 160024 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Systolic Risperidone (3 Mg Po Initial or Prolonged Increased 8:30pm) PS ORAL 8:30PM, 3 MG Pyrexia PO 22-Feb-2006 08:20 AM Page: 1187 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/28/02ISR Number: 3861005-2Report Type:Expedited (15-DaCompany Report #EMADSS2002000432 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Foreign Risperdal (3 Mg Increased Health Tablet) Conjunctival Hyperaemia Professional (Risperidone) PS ORAL 3 MG, 1 IN 1 Dizziness DAY(S), ORAL Headache Fluanxol Depot Hypertension (Flupentixol Tachycardia Decanoate) C Akineton (Biperiden Hydrochloride) C Date:01/28/02ISR Number: 3861069-6Report Type:Expedited (15-DaCompany Report #NSADSS2002002336 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Health Risperdal (1 Mg Hospitalization - Professional Tablet) Initial or Prolonged (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY(S), ORAL Lasix (Furosemide) C Nitroglycerin (Glyceryl Trinitrate) C Nitrobid (Glyceryl Trinitrate) C Avandia (Rosiglitazone Maleate) C Asa (Acetylsalicylic Acid) C Antivert (Ancovert) C Zoloft (Sertraline Hydrochloride) C Date:01/28/02ISR Number: 3861154-9Report Type:Expedited (15-DaCompany Report #EMADSS2002000381 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Risperdal (Tablet) Initial or Prolonged First Degree Health (Risperidone) PS ORAL 1.5 MG, Bradycardia Professional DAILY, ORAL Mitral Valve Stenosis Haldol (Tablet) Sinoatrial Block (Haloperidol) C Somnolence Tavor (Lorazepam) C Date:01/28/02ISR Number: 3861155-0Report Type:Expedited (15-DaCompany Report #APCDSS2002000019 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Urinary Incontinence Foreign Risperdal Hospitalization - Health (Unspecified) Initial or Prolonged Professional (Risperidone) PS ORAL MG, DAILY, Company ORAL Representative 22-Feb-2006 08:20 AM Page: 1188 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/28/02ISR Number: 3861156-2Report Type:Expedited (15-DaCompany Report #EMADSS2002000383 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal (Tablet) Health (Risperidone) PS ORAL ORAL Professional Date:01/28/02ISR Number: 3861157-4Report Type:Expedited (15-DaCompany Report #EMADSS2001007090 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Foreign Risperdal (1 Mg Hospitalization - Extrapyramidal Disorder Health Tablet) Initial or Prolonged Hypothermia Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 Stupor DAY (S), ORAL Lasilix (Furosemide) C Diffu-K (Potassium Chloride) C Seropram (Citalopram Hydrobromide) C Lysanxia (Prazepam) C Nitriderm (Glyceryl Trinitrate) C Date:01/28/02ISR Number: 3861158-6Report Type:Expedited (15-DaCompany Report #EMADSS2002000343 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiopulmonary Failure Foreign Risperdal (1 Mg Hospitalization - Hyperthermia Malignant Health Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Seropram (Citalopram Hydrobromide) SS ORAL 1.5 CAP, DAILY, ORAL Xanax (Alprazolam) SS ORAL 1.5 CAP, DAILY, ORAL Solu-Medrol (Methylprednisolone Sodium Succinate) SS INTRAVENOUS 40 MG, IV Date:01/28/02ISR Number: 3861159-8Report Type:Expedited (15-DaCompany Report #EMADSS2001005486 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Risperidone Phosphokinase Increased Study (Unspecified) Body Temperature Health (Risperidone) PS PATIENT HAD Increased Professional PREVIOUSLY Catatonia RECEIVED Dysphagia RISPERIDONE Headache FROM Muscle Rigidity Topiramate (Capsule) Neuroleptic Malignant (Topiramate) SS ORAL 3 CAP DAILY, Syndrome ORAL Respiratory Failure Placebo (Placebo) SS ORAL 3 CAP, DAILY, Speech Disorder ORAL Lithium (Lithium) SS 22-Feb-2006 08:20 AM Page: 1189 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam (Lorazepam) C Chloral Hydrate (Chloral Hydrate) C Diazepam (Diazepam) C Olanzapine (Olanzapine) C Senna (Senna) C Lactulose (Lactulose) C Haloperidol (Haloperidol) C Lithium Carbonate (Lithium Carbonate) C Date:01/29/02ISR Number: 3860805-2Report Type:Direct Company Report #CTU 160409 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cognitive Disorder Risperdal .25mg PS ORAL .25MG TWICE Disturbance In Attention DAILY ORAL Dysgraphia Depakote C Lethargy Memory Impairment Somnolence Speech Disorder Date:01/29/02ISR Number: 3861469-4Report Type:Expedited (15-DaCompany Report #EMADSS2002000395 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal (2 Mg Initial or Prolonged Dyskinesia Health Tablet) Professional (Risperidone) PS ORAL 2 MG, L2 IN 1 DAY(S), ORAL Remeron (Mitrazapine) SS ORAL 15 MG, DAILY, ORAL Imozop (Zopiclone) C Date:01/29/02ISR Number: 3861474-8Report Type:Expedited (15-DaCompany Report #NSADSS2002000489 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Topamax (Topiramate) PS ORAL 300 MG, Initial or Prolonged Phosphokinase Increased Study DAILY, ORAL Dehydration Health Risperidone Depressed Level Of Professional (Risperidone) SS ORAL 6 MG, DAILY, Consciousness ORAL Mania Lorazepam Neuroleptic Malignant (Lorazepam) SS ORAL 4 MG, DAILY, Syndrome ORAL Pneumonia Psychotic Disorder Respiratory Failure 22-Feb-2006 08:20 AM Page: 1190 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/02ISR Number: 3861692-9Report Type:Expedited (15-DaCompany Report #NSADSS2002002426 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:01/29/02ISR Number: 3861695-4Report Type:Expedited (15-DaCompany Report #NSADSS2002002334 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:01/30/02ISR Number: 3862323-4Report Type:Expedited (15-DaCompany Report #EMADSS2001006357 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Macrocytic Foreign Risperdal Depression Health (Risperidone) PS ORAL ORAL Leukocytosis Professional Sepram (Citalopram) C Myelodysplastic Syndrome Orap (Pimozide) C Date:01/30/02ISR Number: 3862432-XReport Type:Expedited (15-DaCompany Report #EMADSS2002000009 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Escherichia Urinary Tract Foreign Risperdal (4 Mg Initial or Prolonged Infection Health Tablet) Required Urinary Retention Professional (Risperidone) PS UNSPECIFIED Intervention to INCREASED Prevent Permanent DOSE; Impairment/Damage UNSPECIFIED INCREASED Lepticur (Tropatepine Hydrochloride) C ORAL 1 CAP, 1 IN 1 DAY(S), ORAL Date:01/30/02ISR Number: 3863117-6Report Type:Expedited (15-DaCompany Report #EMADSS2002000383 Age:10 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Risperdal (Tablet) Leukopenia Health (Risperidone) PS ORAL 0.5 MG, 2 IN Restlessness Professional 1 DAY(S), Weight Increased ORAL Date:01/30/02ISR Number: 3864318-3Report Type:Expedited (15-DaCompany Report #NSADSS2002002607 Age:16 YR Gender:Male I/FU:I Outcome PT Hospitalization - Akathisia Initial or Prolonged Drooling Lethargy 22-Feb-2006 08:20 AM Page: 1191 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 8 MG, 1 IN 1 DAY(S), ORAL Tregretol (Carbamazepine) C Lamictal (Lamotrigine) C Date:01/31/02ISR Number: 3863311-4Report Type:Expedited (15-DaCompany Report #EMADSS2002000488 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Foreign Risperdal (1 Mg Initial or Prolonged Liver Function Test Health Tablet) Required Abnormal Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 Intervention to Renal Failure Acute DAY(S), ORAL Prevent Permanent Rhabdomyolysis Apodorm (Nitrazepam) C Impairment/Damage Disipal (Orphenadrine Hydrochloride) C Propavan (Propiomazine Maleate) C Stilnoct (Zolpidem Tartrate) C Ergenyl (Valproate Sodium) C Date:01/31/02ISR Number: 3865059-9Report Type:Expedited (15-DaCompany Report #NSADSS2002003115 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal Professional (Unspecified) Company (Risperidone) PS ORAL ORAL Representative Date:02/01/02ISR Number: 3863907-XReport Type:Expedited (15-DaCompany Report #2001AP05963 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Seroquel PS ORAL 300 MG DAILY Health PO Professional Risperdal SS ORAL 12 MG DAILY Other PO Contomin SS ORAL 300 MG DAILY PO Zyprexa SS ORAL 5 MG DAILY PO Zyprexa SS ORAL 10 MG DAILY PO Levotomin C Artane C Tasmolin C Selbex C Rohypnol C 22-Feb-2006 08:20 AM Page: 1192 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/02ISR Number: 3864896-4Report Type:Expedited (15-DaCompany Report #DEU003391 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Conduction Disorder Foreign Akineton Retard PS ORAL 4 MG OD PO Study Haldol SS ORAL 5 MG DAILY PO Health Risperdal SS ORAL 2 MG DAILY PO Professional Other Date:02/04/02ISR Number: 3863898-1Report Type:Expedited (15-DaCompany Report #EMADSS2002000529 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Congenital Foot Foreign Risperdal Malformation Health (Unspecified) Maternal Drugs Affecting Professional (Risperidone) PS INTRA-UTERINE 2 MG, 1 IN 1 Foetus DAY(S), UTERINE Haldol (5 Mg Tablet) (Haloperidol) SS INTRA-UTERINE 5 MG, 1 IN 1 DAY(S), UTERINE Largactil (Chlorpromazine Hydrochloride) C Rivotril (Clonazepam) C Atarax (Hydroxyzine Hydrochloride) C Kardegic (Acetylsalicylate Lysine) C Date:02/04/02ISR Number: 3863902-0Report Type:Expedited (15-DaCompany Report #EMADSS2002000519 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Date:02/04/02ISR Number: 3863904-4Report Type:Expedited (15-DaCompany Report #NSADSS2001038696 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Risperdal Hepatic Enzyme Increased Health (Unspecified) Hepatitis Professional (Risperidone) PS Nausea Company Sertraline Neutropenia Representative (Sertraline) SS Suicide Attempt 22-Feb-2006 08:20 AM Page: 1193 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/02ISR Number: 3863906-8Report Type:Expedited (15-DaCompany Report #EMADSS2002000529 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Maternal Drugs Affecting Foreign Haldol (5 Mg Tablet) Foetus Health (Haloperidol) PS INTRA-UTERINE 5 MG, 1 IN 1 Talipes Professional DAY(S), UTERINE Risperdal (Unspecified) (Risperidone) SS INTRA-UTERINE 2 MG, 1 IN 1 DAY(S), UTERINE Largactil (Chlorpromazine Hydrochloride) C Rivotril (Clonazepam) C Atarax (Hydroxyzine Hydrochloride) C Kardegic (Acetylsalicylate Lysine) C Date:02/04/02ISR Number: 3865030-7Report Type:Expedited (15-DaCompany Report #HQ0282629JAN2002 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Effexor Xr Hallucination Professional (Venlafaxine Tremor Company Hydrochloride, Representative Capsule, Extended Release) PS ORAL 75 MG 2 X PER 1 DAY, ORAL Carbamazepine (Carbamazepine) SS Risperidone (Risperidone,) SS Date:02/04/02ISR Number: 3865145-3Report Type:Expedited (15-DaCompany Report #NSADSS2001038259 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Health Risperdal Initial or Prolonged First Degree Professional (Risperidone) PS ORAL 2 MG, 1 IN 1 Other Blood Pressure Decreased NIGHT(S), Dizziness ORAL Electrocardiogram Effexor (Venlafaxine Abnormal Hydrochloride) C Electrocardiogram T Wave Abnormal Loss Of Consciousness Orthostatic Hypotension Respiratory Rate Increased Sinus Bradycardia Syncope 22-Feb-2006 08:20 AM Page: 1194 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/02ISR Number: 3865383-XReport Type:Expedited (15-DaCompany Report #NSADSS2002003210 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 4 MG, 1 IN 1 DAY(S), ORAL Benadryl (Diphenydramine Hydrochloride) C Date:02/05/02ISR Number: 3865649-3Report Type:Expedited (15-DaCompany Report #EMADSS2002000263 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Haldol (Unspecified) Initial or Prolonged Study (Haloperidol) PS ORAL ORAL Health Risperidone Professional (Unspecified) (Risperidone) SS ORAL ORAL Placebo (Unspecified) (Placebo) SS ORAL ORAL Date:02/05/02ISR Number: 3865706-1Report Type:Expedited (15-DaCompany Report #NSADSS2002003213 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:02/05/02ISR Number: 3866032-7Report Type:Expedited (15-DaCompany Report #02-0126 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phlebitis Health Clomipramine Hcl Initial or Prolonged Pulmonary Embolism Professional Capsules, 75 Mg (Watson Labs, Inc.) PS Watson Labs, Inc. ORAL PO HS 18 MON Clonazepam Tablets 1 Mg (Unknown Manufacturer) SS ORAL 1.5 PO QAM AND 1 PO HS 2 YR Remeron SS ORAL 45 MG PO HS 2 YR Zoloft SS ORAL 250 MG PO AQM Buspar SS ORAL 45 MG PO BID Risperdal SS ORAL 2 MG PO HS Remeron C Zoloft C Buspar C Risperdal C Date:02/05/02ISR Number: 3866144-8Report Type:Expedited (15-DaCompany Report #HQ0226128JAN2002 Age:38 YR Gender:Female I/FU:I Outcome PT Other Depressed Level Of Consciousness 22-Feb-2006 08:20 AM Page: 1195 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrocardiogram Qt Prolonged Electrocardiogram T Wave Report Source Product Role Manufacturer Route Dose Duration Inversion Health Amoxan (Amoxapine, Hypokalaemia Professional Capsule) PS ORAL 1750 MG, Intentional Overdose OVERDOSE Suicide Attempt AMOUNT 1 DAY Nifedipine (Nifedipine) SS ORAL 2 GM, OVERDOSE AMOUNT 1 DAY Resmit (Medazepam) SS ORAL 42 TABLETS, OVERDOSE AMOUNT 1 DAY Risperdal (Risperidone) SS ORAL 45 TABLETS, OVERDOSE AMOUNT 1 DAY Silece (Flunitrazepam) SS ORAL 16 TABLETS, OVERDOSE AMOUNT 1 DAY Date:02/06/02ISR Number: 3864348-1Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11696846 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phlebitis Buspar Tabs PS Bristol-Myers Squibb Initial or Prolonged Pulmonary Embolism Company ORAL 2 YR Clonazepam SS ORAL "1.5 PO qAM and 1 PO HS" 2 YR Clomipramine Hcl Caps 75 Mg SS ORAL at bedtime 2 YR Remeron SS ORAL at bedtime 2 YR Zoloft SS ORAL every morning 2 YR Risperdal SS ORAL at bedtime 2 YR Date:02/06/02ISR Number: 3865377-4Report Type:Expedited (15-DaCompany Report #NSADSS2002003431 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:02/06/02ISR Number: 3865378-6Report Type:Expedited (15-DaCompany Report #NSADSS2002003211 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:02/06/02ISR Number: 3865688-2Report Type:Expedited (15-DaCompany Report #02-0130 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phlebitis Health Clonazepam Tablets 1 Initial or Prolonged Pulmonary Embolism Professional Mg (Unknown 22-Feb-2006 08:20 AM Page: 1196 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Manufacturer) PS ORAL 1.5 PO QAM AND 1 PO HS 2 YR Clomipramine Hcl Capsules, 75 Mg (Watson Labs, Inc) SS Watson Labs, Inc. ORAL 1 PO HS 2 YR Remeron SS ORAL 45MG PO HS 2 YR Zoloft SS ORAL 250MG PO QAM 2 YR Buspar SS ORAL 45MG PO BID 2 YR Risperdal SS ORAL 2MG PO HS 2 YR Date:02/06/02ISR Number: 3865705-XReport Type:Expedited (15-DaCompany Report #NSADSS2002003208 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperidone (Tablet) Professional (Risperidone) PS ORAL 2 MG, 2 IN Company DAILY, ORAL Representative Date:02/06/02ISR Number: 3866181-3Report Type:Expedited (15-DaCompany Report #NSADSS2002001606 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:02/06/02ISR Number: 3866182-5Report Type:Expedited (15-DaCompany Report #NSADSS2001022652 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Failure Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 4 MG, DAILY, ORAL Remeron (Mirtazapine) C Desyrel (Trazodone Hydrochloride) C Date:02/06/02ISR Number: 3866224-7Report Type:Expedited (15-DaCompany Report #EMADSS2002000641 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:02/06/02ISR Number: 3866250-8Report Type:Expedited (15-DaCompany Report #EMADSS2002000607 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Risperdal (Tablet) Initial or Prolonged Syndrome Health (Risperidone) PS ORAL 6 MG, DAILY, Thrombosis Professional ORAL 22-Feb-2006 08:20 AM Page: 1197 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/02ISR Number: 3866941-9Report Type:Expedited (15-DaCompany Report #NSADSS2002000655 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Solution) Professional (Risperidone) PS INTRAVENOUS SEE IMAGE Pepcid (Famotidine) C Isordil (Isosorbide Dinitrate) C Provera (Medroxyprogesterone Acetate) C Paxil (Paroxetine Hydrochloride) C Cleocin (Clindamycin Hydrochloride) C Cleocin (Clindamycin Hydrochloride) C Zithromax (Azithromycin) C Date:02/07/02ISR Number: 3867440-0Report Type:Expedited (15-DaCompany Report #EMADSS2001001462 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal (Tablet) Cystitis Health (Risperidone) PS ORAL 2 MG, DAILY, Leukopenia Professional ORAL Thrombocytopenia Phenytoin (Phenytoin) C Antibiotic C Date:02/07/02ISR Number: 3867743-XReport Type:Expedited (15-DaCompany Report #J081-002-000377 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign E2020 (Donepezil) PS ORAL 3 MG, 1 IN 1 Alanine Aminotransferase Study D, PER ORAL Increased Health Risperdal Aspartate Professional (Risperidone) SS ORAL 1 MG X 2 Aminotransferase TABS, PER Increased ORAL Blood Creatine Vegetamin B Phosphokinase Increased (Combination Drug) C Blood Lactate Tetramide (Mianserin Dehydrogenase Increased Hydrochloride) C Coma Benzalin Dementia Alzheimer'S Type (Nitrazepam) C Facial Pain Insomnia Loss Of Consciousness Memory Impairment Neuroleptic Malignant Syndrome 22-Feb-2006 08:20 AM Page: 1198 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/02ISR Number: 3866673-7Report Type:Direct Company Report #CTU 161366 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Sinus Arrhythmia Risperdal 4mg Janssen PS Janssen ORAL 4MG QHS ORAL Date:02/08/02ISR Number: 3867325-XReport Type:Expedited (15-DaCompany Report #APCDSS2001001332 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Risperdal Initial or Prolonged Compartment Syndrome Health (Unspecified) Required Infarction Professional (Risperidone) PS OVERDOSE UP Intervention to Loss Of Consciousness Company TO 120 MG, Prevent Permanent Overdose Representative STABLE DOSE Impairment/Damage Renal Impairment 3-4 MG/DAY Rhabdomyolysis Haldol (Unspecified) Thrombosis (Haloperidol) SS Date:02/08/02ISR Number: 3867334-0Report Type:Expedited (15-DaCompany Report #EMADSS2002000671 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Engorgement Foreign Risperdal (1 Mg Breast Pain Health Tablet) Dysuria Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 Galactorrhoea DAILY, ORAL Date:02/08/02ISR Number: 3867336-4Report Type:Expedited (15-DaCompany Report #EMADSS2002000683 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Risperdal (Tablet) Initial or Prolonged Iron Deficiency Anaemia Health (Risperidone) PS ORAL SEE IMAGE Professional Trevilor (Venlafaxine Hydrochloride) C Akineton (Biperiden Hydrochloride) C Date:02/08/02ISR Number: 3867339-XReport Type:Expedited (15-DaCompany Report #APCDSS2002000096 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal Leukopenia Health (Unspecified) Thrombocytopenia Professional (Risperidone) PS Temazepam (Temazepam) C Date:02/08/02ISR Number: 3867394-7Report Type:Expedited (15-DaCompany Report #APCDSS2001001332 Age:25 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 1199 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Blood Calcium Decreased Foreign Haldol Body Temperature Health (Unspecified) Increased Professional (Haloperidol) PS Compartment Syndrome Company Risperdal Infarction Representative (Unspecified) Loss Of Consciousness (Risperidone) SS ORAL OVERDOSE UP Muscle Disorder TO 120 MG, Overdose STABLE DOSE 3 Renal Impairment - 4 MG/DAY Rhabdomyolysis Swelling Thrombosis White Blood Cell Count Increased Date:02/08/02ISR Number: 3868617-0Report Type:Expedited (15-DaCompany Report #NSADSS2002003840 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:02/08/02ISR Number: 3868618-2Report Type:Expedited (15-DaCompany Report #NSADSS2002003716 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 ORAL Aciphex (Rabeprazole) SS ORAL 20, ORAL Date:02/11/02ISR Number: 3868982-4Report Type:Expedited (15-DaCompany Report #NSADSS2002004017 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Road Traffic Accident Health Risperdal Initial or Prolonged Syncope Professional (Unspecified) Torsade De Pointes Company (Risperidone) PS ORAL ORAL Representative Date:02/11/02ISR Number: 3869196-4Report Type:Expedited (15-DaCompany Report #002#4#2002-00008(0) Age:97 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aggression Consumer Ppa/Cpm-75/8mg (Otc) Drug Interaction Distributor (Phenylpropanolamine Stupor Hcl, Chlorpheniramine Maleate) PS ORAL 2 IN 24 H, ORAL Risperidone SS ORAL .25MG, 1 IN 1 D, ORAL 22-Feb-2006 08:20 AM Page: 1200 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Paroxetine SS ORAL 10MG, 1 IN 1 D, ORAL Glipizide C Atenolol C Date:02/11/02ISR Number: 3869613-XReport Type:Expedited (15-DaCompany Report #NSADSS2002003955 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 0.1 MG, 2 IN 24 HOUR(S), ORAL Date:02/12/02ISR Number: 3869090-9Report Type:Expedited (15-DaCompany Report #APCDSS2002000115 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Risperdal Health (Risperidone) PS Professional Company Representative Date:02/13/02ISR Number: 3869579-2Report Type:Periodic Company Report #2012371 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycodone Professional Hydrochloride Other (Similar To Nda 20-553) PS Mirtazapine SS Benztropine SS Alprazolam SS Acetaminophen SS Rantidine SS Risperidone SS Date:02/13/02ISR Number: 3870433-0Report Type:Expedited (15-DaCompany Report #NSADSS2002004145 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY (S), ORAL Depakote (Valproate Semisodium) C Vasotec (Enalapril Maleate) C Effexor (Venlafaxine Hydrochloride) C Imuran (Azathioprine) C 22-Feb-2006 08:20 AM Page: 1201 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/02ISR Number: 3870436-6Report Type:Expedited (15-DaCompany Report #NSADSS2002004183 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Consumer Risperdal (2 Mg Mental Disorder Health Tablet) Neutropenia Professional (Risperidone) PS ORAL 2 MG, 1 IN 1 NIGHT (S), ORAL Neurontin (Gabapentin) SS ORAL ORAL Depakote (Valproate Semisodium) C Date:02/13/02ISR Number: 3879049-3Report Type:Periodic Company Report #2014479 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Oxycontin Cr Professional Tablets, 40 Mg Other (Oxycodone Hydrochloride) PS ORAL MG Q12H PO Diphenhydramine Hcl SS Promethazine Hcl SS Effexor (Venlafaxine) SS Gabapentin SS Risperidone SS Clonazepam SS ORAL MG PO Date:02/14/02ISR Number: 3870196-9Report Type:Expedited (15-DaCompany Report #NSADSS2002004375 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sleep Walking Consumer Risperdal (Risperidone) PS ORAL ORAL Date:02/14/02ISR Number: 3870200-8Report Type:Expedited (15-DaCompany Report #NSADSS2002004318 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Consumer Risperdal (Tablet) Initial or Prolonged Renal Failure (Risperidone) PS ORAL SEE IMAGE Haldol (Injection) (Haloperidol) C Date:02/14/02ISR Number: 3870202-1Report Type:Expedited (15-DaCompany Report #NSADSS2002004315 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1202 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/02ISR Number: 3870205-7Report Type:Expedited (15-DaCompany Report #EMADSS2002000671 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Engorgement Foreign Risperdal ( 1 Mg Breast Pain Health Tablet) Dysuria Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 Galactorrhoea DAILY, ORAL Date:02/14/02ISR Number: 3870208-2Report Type:Expedited (15-DaCompany Report #EMADSS2002000711 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Opisthotonus Foreign Risperdal (2 Mg Health Tablet) Professional (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY(S), ORAL Tercian (Cyamemazine) C Date:02/14/02ISR Number: 3870488-3Report Type:Expedited (15-DaCompany Report #A126199 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Consumer Ziprasidone Po PS ORAL PO Intervention to Amnesia Risperdal Prevent Permanent Asthma (Risperidone) SS 12.00 MG Impairment/Damage Bronchitis TOTAL:DAILY Confusional State Flovent Constipation (Fluticasone) SS RESPIRATORY Diabetes Mellitus (INHALATION) 176.00 MCG Drug Interaction TOTAL:BID:INH Hypertension ALATION Insomnia Prozac (Fluoxetine) C Paraesthesia Temazepam C Sedation Allegra Speech Disorder (Fexofenadine) C Weight Increased Diltiazem C Glucophage (Metformin) C Date:02/15/02ISR Number: 3870831-5Report Type:Expedited (15-DaCompany Report #2002-BP-00018BP (0) Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Consumer Catapres Tts Dizziness Health (Clonidine Malaise Professional Hydrochloride) PS 0.1 MG (2.5 Sedation MG, 1 PATCH Q Syncope WEEK), TO Tinnitus Risperidone (Risperidone) SS ?2.5-5.0 MG QD, NR, DISCONTINUED 10/?/2001 AND RESTARTED Zyprexa SS ?2.5-5.0MG QD, NR Effexor C 22-Feb-2006 08:20 AM Page: 1203 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/02ISR Number: 3871278-8Report Type:Expedited (15-DaCompany Report #EMADSS2002000773 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal (Tablet) Study (Risperidone) PS ORAL SEE IMAGE Health Tavor (Lorazepam) C Professional Zyprexa (Olanzapine) C Date:02/19/02ISR Number: 3872055-4Report Type:Expedited (15-DaCompany Report #NSADSS2002004781 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Flutter Foreign Risperdal (Tablet) Cardiac Disorder Health (Risperidone) PS ORAL 2 MG, ORAL Cardiomyopathy Professional Fall Company Representative Date:02/19/02ISR Number: 3872056-6Report Type:Expedited (15-DaCompany Report #EMADSS2002000381 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Risperdal (Tablet) Hospitalization - Bradycardia Health (Risperidone) PS ORAL 1.5 MG, Initial or Prolonged Condition Aggravated Professional DAILY, ORAL Disturbance In Attention Haldol (Tablet) Miosis (Haloperidol) C Mitral Valve Stenosis Tavor (Lorazepam) C Sinoatrial Block Diazepam (Diazepam) C Somnolence Date:02/19/02ISR Number: 3872678-2Report Type:Expedited (15-DaCompany Report #EMADSS2002000263 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Haldol (Unspecified) Initial or Prolonged Loss Of Consciousness Study (Haloperidol) PS ORAL ORAL Orthostatic Hypotension Health Risperidone Professional (Unspecified) (Risperidone) SS ORAL ORAL Placebo (Unspecified) (Placebo) SS ORAL ORAL Biperiden (Biperiden) C Date:02/19/02ISR Number: 3872679-4Report Type:Expedited (15-DaCompany Report #EMADSS2002000607 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Foreign Risperdal (Tablet) Initial or Prolonged Difficulty In Walking Health (Risperidone) PS ORAL 8 MG DAILY Neuroleptic Malignant Professional ORAL Syndrome Tagonis (Paroxetine Thrombosis Hydrochloride) C Atosil (Isopromethazine 22-Feb-2006 08:20 AM Page: 1204 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:02/19/02ISR Number: 3872680-0Report Type:Expedited (15-DaCompany Report #APCDSS2002000065 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Alkaline Foreign Risperdal (Tablet) Other Phosphatase Increased Health (Risperidone) PS ORAL MG DAILY ORAL Blood Lactate Professional Biperiden Dehydrogenase Increased Hydrochloride C-Reactive Protein (Biperiden Increased Hydrochloride) C Depressed Level Of Famotidine Consciousness (Famotidine) C Dysarthria Prednisolone Electrocardiogram (Prednisolone) C Abnormal Alfacalcidol Electroencephalogram (Alfacalcidol) C Abnormal Bufferin (Bufferin) C Quadriplegia Nicardipine Speech Disorder (Nicardipine) C Teprenone (Teprenone) C Flurbiprofen (Flurbiprofen) C Date:02/20/02ISR Number: 3873086-0Report Type:Expedited (15-DaCompany Report #NSADSS2001015831 Age:96 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Consumer Risperdal (Tablet) Initial or Prolonged Coma (Risperidone) PS ORAL 1 MG, 1 IN 1 Dehydration DAY(S) ORAL Lethargy Isosorbide C Urinary Tract Infection Aspirin (Acetylsalicylic Acid) C Atenolol C Triamterene C Glipizide C Date:02/20/02ISR Number: 3873486-9Report Type:Expedited (15-DaCompany Report #FLUV00302000285 Age:70 YR Gender:Male I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Anxiety Aspartate Aminotransferase Increased Blood Creatine Phosphokinase Increased Diet Refusal Excitability Hyperhidrosis Muscle Rigidity Neuroleptic Malignant Syndrome 22-Feb-2006 08:20 AM Page: 1205 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Somnolence Suicidal Ideation Report Source Product Role Manufacturer Route Dose Duration Foreign Fluvoxamine Literature (Fluvoxamine) PS 100 MG DAILY Other Haloperidol (Haloperidol) SS INTRAMUSCULAR 5 MG DAILY IM 2 DAY Chlorpromazine (Chlorpromazine) SS 100 MG DAILY Risperidone (Risperidone) SS 2 MG DAILY Date:02/20/02ISR Number: 3873577-2Report Type:Expedited (15-DaCompany Report #NSADSS2001030327 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL 3 MG, 2 IN 1 DAILY, ORAL Date:02/20/02ISR Number: 3873578-4Report Type:Expedited (15-DaCompany Report #NSADSS2002000601 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Health Risperdal (0.5 Mg Increased Professional Tablet) Heat Exposure Injury (Risperidone) PS ORAL 0.5 MG, 3 IN Neuroleptic Malignant 1 DAY(S), Syndrome ORAL Haloperidol (Haloperidol) C Depakote (Valproate Semisodium) C Plavix (Clopidogrel Sulfate) C Protonix (Pantoprazole) C Date:02/20/02ISR Number: 3873620-0Report Type:Expedited (15-DaCompany Report #NSADSS2002004778 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Risperdal(3 Mg Professional Tablet)(Risperidone) PS ORAL 3 MG, 1 IN 1 DAY(S), ORAL Date:02/20/02ISR Number: 3873708-4Report Type:Expedited (15-DaCompany Report #NSADSS2002004782 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, 1 IN 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 1206 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/02ISR Number: 3873709-6Report Type:Expedited (15-DaCompany Report #NSADSS2002002426 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:02/20/02ISR Number: 3873816-8Report Type:Expedited (15-DaCompany Report #APCDSS2002000109 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Arrest Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS 0.5 MG TWICE DAILY (PATIENT HAD 2 DOSES) Clonazepam (Clonazepam) C Date:02/20/02ISR Number: 3873817-XReport Type:Expedited (15-DaCompany Report #EMADSS2002000641 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal Leukopenia Health (Unspecified) Neutropenia Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Lexomil (Bromazepam) C Fumafer (Ferrous Fumarate) C Deroxat (Paroxetine Hydrochloride) C Date:02/20/02ISR Number: 3873818-1Report Type:Expedited (15-DaCompany Report #APCDSS2002000067 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electroencephalogram Foreign Risperdal Initial or Prolonged Abnormal Health (Unspecified) Other Fracture Professional (Risperidone) PS ORAL MG, DAILY, Injury ORAL Suicide Attempt Haldol (Unspecified) (Haloperidol) SS MG, DAILY Carbamazepine (Carbamazepine) C Zonisamide (Zonisamide) C Clonazepam (Clonazepam) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Diazepam (Diazepam) C Magnesium Oxide (Magnesium Oxide) C Solitax-H (Nacl, 22-Feb-2006 08:20 AM Page: 1207 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Kcl) C Date:02/20/02ISR Number: 3873830-2Report Type:Expedited (15-DaCompany Report #EMADSS2001000693 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Risperdal Initial or Prolonged Toxic Epidermal Health (Unspecified) Necrolysis Professional (Risperidone) PS Dehydrobenzperidol (Droperidol) SS Zyprexa (Olanzapine) C Loramet (Lormetazepam) C Dhpb C Disipal (Orphenadrine Hydrochloride) C Tranxene (Clorazepate Dipotassium) C Etumine (Clotiapine) C Clopixol Acutard (Zuclopenthixol Acetate) C Date:02/20/02ISR Number: 3873831-4Report Type:Expedited (15-DaCompany Report #EMADSS2002000854 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Foreign Risperdal Initial or Prolonged Leukopenia Health (Unspecified) Thrombocytopenia Professional (Risperidone) PS ORAL SEE IMAGE Remergil (Mirtazapine) C Isoket (Isosorbide Dinitrate) C Delix (Ramipril) C Norvasc (Amlodipine Besilate) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Euthyrox (Levothyroxine Sodium) C Date:02/20/02ISR Number: 3873893-4Report Type:Expedited (15-DaCompany Report #FLUV00302000457 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Lissencephaly Foreign Depromel Taken By Maternal Drugs Affecting Health Mother (Fluvoxamine Foetus Professional Maleate) PS 50 MG DAILY Other PL Risperdal Taken By Mother (Risperidone) SS 1 MG DAILY PL Depas Taken By Mother (Etizolam) SS 1 MG DAILY PL 22-Feb-2006 08:20 AM Page: 1208 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/02ISR Number: 3872580-6Report Type:Direct Company Report #CTU 162080 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Risperdal 1mg Dizziness Jannsen PS Jannsen ORAL 1MG BID ORAL Hypotension Depakote Ec C Docusate Na C Multi Vit C Lorazepam C Maalox C Date:02/21/02ISR Number: 3872766-0Report Type:Direct Company Report #CTU 162032 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Disorder Risperidone PS 2.5 MG QD 3 DAY Muscle Rigidity Depakote C Tremor Prozac C Date:02/21/02ISR Number: 3872794-5Report Type:Direct Company Report #CTU 162070 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Torticollis Quetiapine PS Initial or Prolonged Risperidone SS Date:02/22/02ISR Number: 3875064-4Report Type:Expedited (15-DaCompany Report #A0359167A Age:97 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aggression Consumer Paxil (Paroxetine Other Drooling Hydrochloride) PS ORAL 10 MG / PER Mental Status Changes DAY / ORAL Sedation Risperidone .25 Mg Stupor (Risperidone) SS ORAL .25 MG PER DAY ORAL Contac 12-Hour Capsule (Contac 12-Hour) SS ORAL ORAL Glipizide C Atenolol C Date:02/22/02ISR Number: 3875240-0Report Type:Expedited (15-DaCompany Report #EMADSS2002001013 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Foreign Reminyl Initial or Prolonged Dyskinesia Health (Galantamine) PS ORAL 24 MG, DAY Dystonia Professional (S), ORAL Gait Disturbance Dipiperon (40 Mg Movement Disorder Tablet) Muscle Disorder (Pipamperone) SS ORAL 160 MG, DAY Muscle Tightness (S), ORAL Myosclerosis Risperdal (Risperidone) SS ORAL 1 MG, DAY (S), ORAL Zyprexa (Olanzapine) SS ORAL 2.5 MG, DAY 22-Feb-2006 08:20 AM Page: 1209 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (S), ORAL Akatinol Mematine (Memantine) C Presomen (Estrogens Conjugated) C Date:02/22/02ISR Number: 3875241-2Report Type:Expedited (15-DaCompany Report #EMADSS2002000924 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal ( Pyrexia Health Unspecified) Professional (Risperidone) PS ORAL ORAL Tegretol (Carbamazepine) C Date:02/25/02ISR Number: 3874647-5Report Type:Expedited (15-DaCompany Report #NSADSS2001039330 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Topamax Cardiac Disorder Professional (Unspecified) Drug Toxicity (Topiramate) PS ORAL ORAL Risperdal (2 Mg Tablet) (Risperidone) SS ORAL 2 MG, 2 IN DAILY, ORAL Citalopram (Citalopram) SS Propoxyphene (Dextropropoxyphene) SS Quetiapine (Quetiapine) SS Triazolam (Triazolam) SS Diphenhydramine (Diphenhydramine) C Acetaminophen (Paracetamol) C Bupropion (Amfebutamone) C Date:02/26/02ISR Number: 3874613-XReport Type:Expedited (15-DaCompany Report #EMADSS2002001079 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Risperdal Increased Health (Risperidone) PS 2 MG, DAILY White Blood Cell Count Professional Decreased Date:02/26/02ISR Number: 3875702-6Report Type:Expedited (15-DaCompany Report #HQ0892522FEB2002 Age: Gender:Unknown I/FU:I Outcome PT Report Source Other Drug Interaction Health Dysphemia Professional Company 22-Feb-2006 08:20 AM Page: 1210 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Effexor Xr (Venlafaxine Hydrochloride, Capsule, Extended Release) PS ORAL ORAL Risperdal (Risperidone, ) SS Date:02/26/02ISR Number: 3875776-2Report Type:Expedited (15-DaCompany Report #NSADSS2002005591 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiotoxicity Health Risperdal Professional (Risperidone) PS ORAL ORAL Company Representative Date:02/26/02ISR Number: 3875788-9Report Type:Expedited (15-DaCompany Report #NSADSS2002004976 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:02/26/02ISR Number: 3875789-0Report Type:Expedited (15-DaCompany Report #NSADSS2001022651 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Respiratory Arrest Health Risperdal Intervention to Professional (Risperidone) PS ORAL ORAL Prevent Permanent Company Impairment/Damage Representative Date:02/26/02ISR Number: 3875790-7Report Type:Expedited (15-DaCompany Report #NSADSS2001039330 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Risperdal Cardiac Disorder Professional (Risperidone) PS ORAL 2 MG, 2 IN Drug Toxicity DAILY, ORAL Topamax (Unspecified) (Topiramate) SS ORAL ORAL Propoxyphene (Dextropropoxyphene) SS Citalopram (Citalopram) SS Quetiapine (Quetiapine) SS Triazolam (Triazolam) SS Diphenhydramine (Diphenhydramine) C Acetaminophen 22-Feb-2006 08:20 AM Page: 1211 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Paracetamol) C Bupropion (Amfebutamone) C Date:02/26/02ISR Number: 3875910-4Report Type:Expedited (15-DaCompany Report #APCDSS2002000142 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Foreign Risperdal Life-Threatening Depressed Level Of Health (Unspecified) Hospitalization - Consciousness Professional (Risperidone) PS Initial or Prolonged Dermatitis Ibuprofen Required Fall (Ibuprofen) C Intervention to Femoral Neck Fracture Prevent Permanent Impairment/Damage Date:02/26/02ISR Number: 3875913-XReport Type:Expedited (15-DaCompany Report #EMADSS2002001032 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal Initial or Prolonged Health (Unspecified) Professional (Risperidone) PS ORAL SEE IMAGE Lorazepam (Lorazepam) C Flunitrazepam (Flunitrazepam) C Date:02/26/02ISR Number: 3875916-5Report Type:Expedited (15-DaCompany Report #EMADSS2002000683 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Granulocytopenia Foreign Risperdal (Tablet) Initial or Prolonged Iron Deficiency Anaemia Health (Risperidone) PS ORAL SEE IMAGE Leukopenia Professional Trevilor (Venlafaxine Hydrochloride) C Akineton (Biperiden Hydrochloride) C Tavor (Lorazepam) C Date:02/26/02ISR Number: 3875934-7Report Type:Expedited (15-DaCompany Report #NSADSS2002005527 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Health Risperdal Initial or Prolonged Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:02/26/02ISR Number: 3875937-2Report Type:Expedited (15-DaCompany Report #NSADSS2002005183 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, 1 IN 24 22-Feb-2006 08:20 AM Page: 1212 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report HOUR (S), ORAL Date:02/26/02ISR Number: 3875952-9Report Type:Expedited (15-DaCompany Report #NSADSS2001022551 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Risperdal Initial or Prolonged Cognitive Disorder Professional (Unspecified) Dyspnoea (Risperidone) PS ORAL 2 MG, DAILY, Hallucinations, Mixed ORAL 1 MON Serotonin Syndrome Zoloft (Sertraline Hydrochloride) SS ORAL 100 MG, DAILY, ORAL Date:02/27/02ISR Number: 3874916-9Report Type:Direct Company Report #CTU 162368 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Risperidone PS ORAL 0.5MG PO Q2H Extrapyramidal Disorder PRN 9 MON Sedation Gabapentin C Paroxetine C Buspirone C Bupropion C Date:02/27/02ISR Number: 3874938-8Report Type:Direct Company Report #CTU 162346 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Haloperidol PS Initial or Prolonged Risperidone SS Date:02/27/02ISR Number: 3877338-XReport Type:Expedited (15-DaCompany Report #NSADSS2002005513 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:02/27/02ISR Number: 3877339-1Report Type:Expedited (15-DaCompany Report #NSADSS2002005518 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:02/28/02ISR Number: 3877503-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE00836 Age:74 YR Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Anxiety Other Blood Creatine Phosphokinase Increased Blood Creatine 22-Feb-2006 08:20 AM Page: 1213 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphokinase Mb Increased Chills Dystonia Report Source Product Role Manufacturer Route Dose Duration Hypertension Foreign Exelon Paranoia Study (Rivastigmine) Health Capsule PS ORAL ORAL Professional Risperdal Other (Risperidone) SS ORAL ORAL Prothazin (Promethazine Hydrochloride) SS ORAL 50 MG/DAY, ORAL Eunerpan(Meleperone Hydrochloride) C Norvasc C Reminyl (Galantamine) C Date:02/28/02ISR Number: 3877622-XReport Type:Expedited (15-DaCompany Report #EMADSS2002000488 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Foreign Risperdal(1 Mg Initial or Prolonged Abnormal Health Tablet)(Risperidone) PS ORAL 1 MG, 2 IN 1 Required Muscular Weakness Professional DAY(S), ORAL Intervention to Myalgia Apodorm(Nitrazepam) C Prevent Permanent Myoglobin Blood Increased Disipal(Orphenadrine Impairment/Damage Renal Failure Acute Hydrochloride) C Rhabdomyolysis Propavan(Propiomazin e Maleate) C Stilnoct (Zolpidem Tartrate) C Ergenyl(Valproate Sodium) C Date:02/28/02ISR Number: 3877623-1Report Type:Expedited (15-DaCompany Report #APCDSS2002000142 Age:84 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Amnesia Foreign Risperdal(Risperidon Life-Threatening Confusional State Health e) PS Hospitalization - Depressed Level Of Professional Ibuprofen C Initial or Prolonged Consciousness Required Emotional Disorder Intervention to Fall Prevent Permanent Femoral Neck Fracture Impairment/Damage Hallucination Date:02/28/02ISR Number: 3877624-3Report Type:Expedited (15-DaCompany Report #EMADSS2002001247 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal(3 Mg Health Tablet)(Risperidone) PS ORAL 3 MG, DAILY, Professional ORAL Amitriptylin(Amitrip tyline) C Triamteren(Triamtere 22-Feb-2006 08:20 AM Page: 1214 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ne) C Etilefrin(Etilefrine ) C Carbamazepine(Carbam azepine) C Remifemin(Cimicifuga ) C Date:02/28/02ISR Number: 3880878-0Report Type:Expedited (15-DaCompany Report #B0255351A Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Foreign Paxil (Paroxetine Drug Interaction Health Hydrochloride) PS ORAL ORAL Dystonia Professional Paxil (Paroxetine Tardive Dyskinesia Hydrochloride) SS ORAL ORAL Risperidone (Risperidone) SS ORAL ORAL Risperidone (Risperidone) SS ORAL ORAL Risperidone (Risperidone) SS ORAL ORAL Biperiden C Fluphenazine C Haloperidol Decanoate C Date:03/01/02ISR Number: 3878286-1Report Type:Direct Company Report #CTU 162672 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Risperdal 2mg Janssen PS Janssen ORAL 2MG D ORAL Date:03/04/02ISR Number: 3879770-7Report Type:Direct Company Report #CTU 162738 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Risperdal 2 Mg Qhs PS 2MG QHS Initial or Prolonged Confusional State Seroquel 100mg Po Q Parkinsonism 6h SS ORAL 100MG PO Q 6H Lotensin C Zantac C Folate C Atarax C Tylenol C Maalox C Remeron C Cardura C Sinemet C Aricept C Cogentin C Depakote C Lasix C Lopressor C Pepcid C Seroquel C 22-Feb-2006 08:20 AM Page: 1215 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/02ISR Number: 3878981-4Report Type:Expedited (15-DaCompany Report #NSADSS2002005931 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 2 MG, 1 DAY(S), ORAL Date:03/05/02ISR Number: 3879104-8Report Type:Expedited (15-DaCompany Report #NSADSS2002003840 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Glyburide (Glibenclamide) C Lotensin (Benazepril Hydrochloride) C Date:03/05/02ISR Number: 3879108-5Report Type:Expedited (15-DaCompany Report #NSADSS2002004017 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Road Traffic Accident Health Risperdal Initial or Prolonged Syncope Professional (Unspecified) Torsade De Pointes Company (Risperidone) PS ORAL ORAL Representative Trilafon (Perphenazine) C Lithium (Lithium) C Rabeprazole (Rabeprazole) C Benztropine (Benztropine) C Gemfibrozil (Gemfibrozil) C Date:03/05/02ISR Number: 3879113-9Report Type:Expedited (15-DaCompany Report #NSADSS2002006236 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hip Fracture Consumer Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:03/05/02ISR Number: 3879116-4Report Type:Expedited (15-DaCompany Report #NSADSS2002006263 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1216 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/02ISR Number: 3879342-4Report Type:Expedited (15-DaCompany Report #NSADSS2002006275 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Risperidal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, 1 IN 1 DAILY ORAL Cogentin (Benzatropine Mesilate) C Ativan (Lorazepam) C Date:03/05/02ISR Number: 3879345-XReport Type:Expedited (15-DaCompany Report #NSADSS2002005761 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Cancer Health Risperdal Galactorrhoea Professional (Unspecified) Company (Risperidone) PS ORAL ORAL Representative Date:03/05/02ISR Number: 3879536-8Report Type:Expedited (15-DaCompany Report #EMADSS2002001216 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphocyte Count Foreign Risperdal Decreased Health (Risperidone) PS 2 MG, DAILY Neutrophil Count Professional Clonidine Decreased (Clonidine) C Sulpiride (Sulpiride) C Date:03/05/02ISR Number: 3879537-XReport Type:Expedited (15-DaCompany Report #EMADSS2001003405 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Risperidone (Tablet) Initial or Prolonged Cardiomyopathy Health (Risperidone) PS ORAL 2 MG, 4 IN 1 Chest Pain Professional DAILY, ORAL Dyspnoea Company Nozinan Extrasystoles Representative (Levomepromazine) C Fall Lexomil (Bromazepam) C Fibrin D Dimer Increased Athymil (Mianserin Headache Hydrochloride) C Malaise Stilnox (Zolpidem) C Pulmonary Embolism Ventricular Hypokinesia Vertigo Date:03/05/02ISR Number: 3880097-8Report Type:Expedited (15-DaCompany Report #EMADSS2002001079 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal White Blood Cell Count Health (Unspecified) Decreased Professional (Risperidone) PS 2 MG DAILY 22-Feb-2006 08:20 AM Page: 1217 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/02ISR Number: 3880307-7Report Type:Expedited (15-DaCompany Report #EMADSS2002001339 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Risperdal Initial or Prolonged Ileus Paralytic Health (Unspecified) Neuroleptic Malignant Professional (Risperidone) PS 1 MG, 1 IN 1 Syndrome DAY (S) Somnolence Urinary Retention Date:03/05/02ISR Number: 3880419-8Report Type:Expedited (15-DaCompany Report #EMADSS2002001256 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Risperdal (2 Mg Initial or Prolonged Neuroleptic Malignant Health Tablet) Syndrome Professional (Risperidone) PS ORAL 2 MG, ORAL Rhabdomyolysis Acetensil (Enalapril Maleate) C Date:03/07/02ISR Number: 3880530-1Report Type:Expedited (15-DaCompany Report #EMADSS2001005021 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperidone Study (Unspecified) Health (Risperidone) PS ORAL 2 MG, DAILY, Professional ORAL Date:03/07/02ISR Number: 3880536-2Report Type:Expedited (15-DaCompany Report #EMADSS2001007501 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Lymphopenia Health (Unspecified) Neutropenia Professional (Risperidone) PS ORAL 2 MG, DAILY, Company ORAL Representative Vitamin B1b6 (Vitamin B1 And B6) C Avlocardyl (Propranolol) C Stilnox (Zolpidem) C Date:03/07/02ISR Number: 3881342-5Report Type:Expedited (15-DaCompany Report #NSADSS2002003115 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal Professional (Risperidone) PS ORAL 4, DAILY, Company ORAL Representative Benztropine (Benztropine) C Ssri (Ssri) C 22-Feb-2006 08:20 AM Page: 1218 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/02ISR Number: 3881361-9Report Type:Expedited (15-DaCompany Report #NSADSS2002006394 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:03/07/02ISR Number: 3881404-2Report Type:Expedited (15-DaCompany Report #EMADSS2002001369 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphonia Foreign Risperdal Dystonia Health (Unspecified) Speech Disorder Professional (Risperidone) PS ORAL 6 MG, DAY(S), Tremor ORAL Date:03/08/02ISR Number: 3881448-0Report Type:Expedited (15-DaCompany Report #NSADSS200136822 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Risperdal PS ORAL 6 MG, Neutropenia Health DAILY,ORAL Professional Clozapine (Clozapine) C Lamotrigine (Lamotrigine) C Revia (Naltrexone) C Date:03/08/02ISR Number: 3881740-XReport Type:Expedited (15-DaCompany Report #NSADSS2002006831 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Acute Health Risperdal Initial or Prolonged Professional (Unspecified) (Risperidone) PS Date:03/08/02ISR Number: 3882185-9Report Type:Expedited (15-DaCompany Report #NSADSS2002006813 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Consumer Risperdal (0.5 Mg Health Tablet) Professional (Risperidone) PS ORAL 0.5 MG , 4 IN DAILY ORAL Date:03/08/02ISR Number: 3882186-0Report Type:Expedited (15-DaCompany Report #NSADSS2001026629 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1219 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/02ISR Number: 3882220-8Report Type:Expedited (15-DaCompany Report #NSADSS2002003210 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (4 Mg Professional Tablet) (Risperidone) PS ORAL 4 MG, 1 IN 1 DAY(S), ORAL Benadryl (Diphenhydramine Hydrochloride) C Date:03/12/02ISR Number: 3882242-7Report Type:Expedited (15-DaCompany Report #EMADSS2002001493 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Risperidone) PS ORAL 3 MG, DAILY, Professional ORAL Other Date:03/12/02ISR Number: 3882244-0Report Type:Expedited (15-DaCompany Report #EMADSS2002001473 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperidone Cardiac Failure Health (Risperidone) PS 0.5 MG, DAILY Hypertension Professional Date:03/12/02ISR Number: 3882457-8Report Type:Expedited (15-DaCompany Report #NSADSS2002002334 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperdone) PS ORAL 4.5 MG, DAILY, ORAL Prolixin Decanoate (Fluphenazine Decanoate) C Congentin (Benzatropine Mesilate) C Date:03/12/02ISR Number: 3882607-3Report Type:Expedited (15-DaCompany Report #NSADSS2002004315 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:03/12/02ISR Number: 3882626-7Report Type:Expedited (15-DaCompany Report #A126199 Age:45 YR Gender:Female I/FU:F Outcome Required Intervention to 22-Feb-2006 08:20 AM Page: 1220 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Amnesia Consumer Ziprasidone Po PS ORAL 20.00 MG Asthma Health TOTAL:DAILY:O Bronchitis Professional RAL Constipation Risperdal Coprolalia (Risperidone) SS 12.00 MG Diabetes Mellitus TOTAL:DAILY:U Hypertension NKNOWN Impulsive Behaviour Flovent Insomnia (Fluticasone) SS RESPIRATORY Paraesthesia (INHALATION) 176.00 MCG Sedation TOTAL:BID:INH Weight Increased ALATION Prozac (Fluoxetine) C Temazepam C Allegra (Fexofenadine) C Diltiazem C Glucophage (Metformin) C Date:03/12/02ISR Number: 3882747-9Report Type:Expedited (15-DaCompany Report #EMADSS2002001537 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Foreign Risperdal (Tablet) Initial or Prolonged Pulmonary Disease Health (Risperidone) PS ORAL 1.5 MG, Salivary Hypersecretion Professional DAILY, ORAL Eunerpan (Melperone Hydrochloride) C Date:03/12/02ISR Number: 3882748-0Report Type:Expedited (15-DaCompany Report #EMADSS2002001564 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Shock Foreign Risperdal (Solution) Health (Risperidone) PS ORAL 4 MG, DAILY, Professional ORAL Flupentixol Decanoate (Flupentixol Decanoate) C Metoprolol (Metoprolol) C Date:03/12/02ISR Number: 3882872-2Report Type:Expedited (15-DaCompany Report #D0038057A Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coordination Abnormal Foreign Paxil Tablet Required Depression Health (Paroxetine Intervention to Intentional Overdose Professional Hydrochloride) PS ORAL 20 MG / Prevent Permanent Somnolence SINGLE DOSE / Impairment/Damage ORAL Risperidone Tablet (Risperidone) SS ORAL 1 MG / SINGLE 22-Feb-2006 08:20 AM Page: 1221 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DOSE / ORAL Vivinox Schlafdragees Tablet (Vivinox Schlafdragees) SS ORAL 1 TABLET / SINGLE DOSE / ORAL Doxylamine Succinate Tablet (Doxylamine Succinate) SS ORAL 25 MG / SINGLE DOSE / ORAL Date:03/12/02ISR Number: 3882884-9Report Type:Expedited (15-DaCompany Report #NSADSS2002006991 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY(S), ORAL Date:03/12/02ISR Number: 3882885-0Report Type:Expedited (15-DaCompany Report #NSADSS2002006990 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:03/12/02ISR Number: 3882903-XReport Type:Expedited (15-DaCompany Report #EMADSS2002001540 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 3 MG, DAILY, ORAL Eunerpan (Melperone Hydrochfloride) C Valprolept (Valproate Sodium) C Date:03/12/02ISR Number: 3883058-8Report Type:Expedited (15-DaCompany Report #B0253211A2001020217-1 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Literature Thorazine Tablet Hospitalization - Circulatory Collapse Health (Chlorpromazine Hcl) PS ORAL 300 MG/ PER Initial or Prolonged Convulsion Professional DAY/ ORAL Required Dyspnoea Other Risperidone Tablet Intervention to Heart Rate Irregular (Risperidone) SS ORAL 3 MG/ PER Prevent Permanent Torsade De Pointes DAY/ ORAL Impairment/Damage Urinary Tract Infection Pipamperone Tablet Ventricular Fibrillation (Pipamperone) SS ORAL 150 MG/ PER DAY/ ORAL Promethazine C Nitrazepam C Methotrimeprazine C 22-Feb-2006 08:20 AM Page: 1222 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Camostat Mesylate C Pravastatin C Date:03/14/02ISR Number: 3883827-4Report Type:Expedited (15-DaCompany Report #01-1953 FOL#1 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Grand Mal Convulsion Foreign Loxitane (Loxapac) Hospitalization - Somnolence Health Capsules, Wyeth Initial or Prolonged Professional Ayerst PS Wyeth Ayerst ORAL 15 MG 1 X PER Company 1 DAY, ORAL 305 DAY Representative Risperdal (Risperidone) SS ORAL 500 UG 1 X PER 1 DAY, ORAL 28 DAY Serenase (Haloperidol) SS ORAL 2 MG 1 X PER 1 DAY, ORAL 305 DAY Zyprexa (Olanzapine) SS ORAL 2.5 MG 1 X PER 1 DAY, ORAL 301 DAY Date:03/15/02ISR Number: 3884367-9Report Type:Expedited (15-DaCompany Report #APCDSS2001001371 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Foreign Risperdal (Tablet) Sudden Death Health (Risperidone) PS SEE IMAGE FOR Professional DOSAGE TEXT & THERAPY DATES Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS VARING DOSES FROM 25 TO 300 MG DAILY Quetiapine Fumarate (Quetiapine Fumarate) SS VARING DOSES FROM 50 TO 600 MG DAILY Olanzapine (Olanzapine) SS VARING DOSES FROM 5 TO 10 MG DAILY Flunitrazepam (Flunitrazepam) SS VARING DOSE FROM 2 MG TO 4 MG Levomepromazine (Levomepromazine) SS VARING DOSE FROM 10 MG TO 25 MG Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Biperiden Hydrochloride 22-Feb-2006 08:20 AM Page: 1223 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Biperiden Hydrochloride) C Teprenone (Teprenone) C Date:03/15/02ISR Number: 3884368-0Report Type:Expedited (15-DaCompany Report #APCDSS2002000067 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Risperdal (Tablet) Initial or Prolonged Phosphatase Increased Health (Risperidone) PS ORAL MG, DAILY, Other Condition Aggravated Professional ORAL Delusion Haldol (Unspecified) Electroencephalogram (Haloperidol) SS MG, DAILY, Abnormal Carbamazepine Fall (Carbamazepine) SS ORAL 200-400 MG Fracture DAILY, PO Hallucination, Auditory Zonisamide Inflammation (Zonisamide) SS ORAL 1) MG, DAILY, Injury ORAL; 2) Suicide Attempt ORAL Clonazepam (Clonazepam) SS ORAL 1) MG, DAILY, ORAL; 2) ORAL Biperiden Hydrochlorie (Biperiden Hydrochloride) SS ORAL 2-3 MG DAILY, PO Diazepam (Diazepam) SS ORAL MG, DAILY, ORAL Magnesium Oxide (Magnesium Oxide) SS ORAL G, DAILY, ORAL Solitax-H (Nacl, Kcl) C Date:03/15/02ISR Number: 3884568-XReport Type:Expedited (15-DaCompany Report #NSADSS2001027374 Age:88 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAY(S), ORAL Date:03/15/02ISR Number: 3884570-8Report Type:Expedited (15-DaCompany Report #NSADSS2002007215 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1224 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/02ISR Number: 3884574-5Report Type:Expedited (15-DaCompany Report #NSADSS2002007536 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:03/15/02ISR Number: 3884917-2Report Type:Expedited (15-DaCompany Report #EMADSS2002001629 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypotension Foreign Risperdal Post Procedural Health (Unspecified) Haemorrhage Professional (Risperidone) PS ORAL 1.5 MG, ORAL Shock Dipiperon (40 Mg Tablet) (Pipamperone) SS ORAL 40 MG, ORAL Akatinol (Memantine Hydrochloride) SS ORAL 10 DROP, ORAL Date:03/15/02ISR Number: 3884921-4Report Type:Expedited (15-DaCompany Report #APCDSS2002000190 Age:1 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperidone Initial or Prolonged Convulsion Health (Unspecified) Maternal Drugs Affecting Professional (Risperidone) PS MG, UTERINE Foetus Clomipramine Neonatal Apnoeic Attack Hydrochloride (Clomipramine Hydrochloride) SS TABLE, UTERINE Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) SS MG, UTERINE Date:03/18/02ISR Number: 3884744-6Report Type:Expedited (15-DaCompany Report #NSADSS2002007986 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 3 MG, 2 IN DAILY, ORAL Date:03/18/02ISR Number: 3884745-8Report Type:Expedited (15-DaCompany Report #NSADSS2002007528 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 1225 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/02ISR Number: 3884746-XReport Type:Expedited (15-DaCompany Report #NSADSS2002007532 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:03/18/02ISR Number: 3884748-3Report Type:Expedited (15-DaCompany Report #NSADSS2002007697 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:03/18/02ISR Number: 3885109-3Report Type:Expedited (15-DaCompany Report #2002UW03403 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Unevaluable Event Consumer Seroquel "Zeneca" PS "Zeneca" ORAL 25 MG DAILY Initial or Prolonged PO Risperdal SS Date:03/18/02ISR Number: 3885178-0Report Type:Expedited (15-DaCompany Report #EMADSS2002001697 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Risperdal PS ORAL 1 MG, DAILY, Initial or Prolonged Blood Creatine Health ORAL 1 YR Disability Phosphokinase Increased Professional Akineton (Biperiden Muscular Weakness Hydrochloride) C Myalgia Moduretic Myocardial Infarction (Moduretic) C Digoxin (Digoxin) C Sintrom (Acenocoumarol) C Seresta (Oxazepam) C Date:03/19/02ISR Number: 3885567-4Report Type:Expedited (15-DaCompany Report #NSADSS2002008128 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 1 NIGHT(S), ORAL Date:03/19/02ISR Number: 3886014-9Report Type:Expedited (15-DaCompany Report #A205753 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Health Vistaril Capsules PS Intervention to Professional Ziprasidone SS Prevent Permanent Company Risperdal SS Impairment/Damage Representative Paxil SS 22-Feb-2006 08:20 AM Page: 1226 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tenormin (Atenolol) C Hydrochlorothiazide C Lescol (Fluvastatin) C Zocor (Simvastatin) C Date:03/19/02ISR Number: 3886076-9Report Type:Expedited (15-DaCompany Report #NSADSS2002007988 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:03/19/02ISR Number: 3886101-5Report Type:Expedited (15-DaCompany Report #NSADSS2002008155 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:03/20/02ISR Number: 3884877-4Report Type:Expedited (15-DaCompany Report #EMADSS2002001803 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Induced Haldol PS ORAL 3 DAY Initial or Prolonged Catatonia Risperdal SS UNKNOWN 3 DAY Drug Exposure During Lorazepam C UNKNOWN Pregnancy Date:03/20/02ISR Number: 3886211-2Report Type:Expedited (15-DaCompany Report #APCDSS2002000065 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Alkaline Foreign Risperdal (Tablet) Hospitalization - Phosphatase Increased Health (Risperidone) PS ORAL MG, DAILY, Initial or Prolonged Blood Lactate Professional ORAL Dehydrogenase Increased Famotidine C-Reactive Protein (Famotidine) C Increased Prednisolone Constipation (Prednisolone) C Depressed Level Of Alfacalllcidol Consciousness (Alfacalcidol) C Dysarthria Bufferin (Bufferin) C Electrocardiogram Nicardipine Abnormal Hydrochloride Hypotonia (Nicardipine Nervous System Disorder Hydrochloride) C Quadriplegia Teprenone (Teprenone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Perosperine Hydrochloride Hydrate C Flurbiprofen (Flurbiprofen) C 22-Feb-2006 08:20 AM Page: 1227 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/02ISR Number: 3886466-4Report Type:Direct Company Report #CTU 163855 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperprolactinaemia Risperidone 2mg Initial or Prolonged Hypertrophy Breast Tablets Janssen PS Janssen ORAL 2MG BID ORAL Other Clonidine C Date:03/21/02ISR Number: 3885339-0Report Type:Expedited (15-DaCompany Report #EMADSS2002001216 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Lymphocyte Count Risperdal PS UNKNOWN Decreased Risperdal C UNKNOWN Neutrophil Count Risperdal C UNKNOWN Decreased Clonidine C UNKNOWN Sulpiride C UNKNOWN Date:03/21/02ISR Number: 3885341-9Report Type:Expedited (15-DaCompany Report #EMADSS2002001797 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Risperdal PS ORAL Life-Threatening Bronchospasm Depamide C UNKNOWN Vomiting Serevent C UNKNOWN Ventoline C UNKNOWN Zyrtec C UNKNOWN Date:03/21/02ISR Number: 3887048-0Report Type:Expedited (15-DaCompany Report #EMADSS2002001788 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Pain In Extremity Foreign Risperdal Other Paraesthesia Health (Unspecified) Professional (Reisperidone) PS Date:03/21/02ISR Number: 3887050-9Report Type:Expedited (15-DaCompany Report # EMADSS2002001803 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Induced Foreign Haladol (5mg Tablet) Initial or Prolonged Catatonia Health (Haloperidol) PS ORAL 5 MG, 3 IN 1 Other Complications Of Maternal Professional DAY(S), ORAL Exposure To Therapeutic Risperdal (Tablet) Drugs (Risperidone) SS 3 MG, DAILY Maternal Drugs Affecting Lorazepam Foetus (Lorazepam) C Pregnancy Date:03/21/02ISR Number: 3887052-2Report Type:Expedited (15-DaCompany Report #EMADSS2002001803 Age:24 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abortion Induced Initial or Prolonged Catatonia Other Complications Of Maternal Exposure To Therapeutic 22-Feb-2006 08:20 AM Page: 1228 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drugs Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal (Tablet) Health (Risperidone) PS 3 MG, DAILY Professional Haldol (5mg Tablet) (Haloperidol) SS ORAL 5MG, 3 IN 1 DAY, ORAL Lorazepam (Lorazepam) C Date:03/21/02ISR Number: 3887072-8Report Type:Expedited (15-DaCompany Report #NSADSS2002008704 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, 1 IN 1 DAILY, ORAL Date:03/21/02ISR Number: 3887073-XReport Type:Expedited (15-DaCompany Report #NSADSS2002008708 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:03/21/02ISR Number: 3887203-XReport Type:Expedited (15-DaCompany Report #FR8931615MAR2002 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchitis Acute Viral Health Effexor Lp Hallucination Professional (Venlafaxine Neutropenia Hydrochloride,) PS ORAL 75 MG White Blood Cell Count DAILY/ORAL Decreased Risperdal (Risperidone, ,0) SS ORAL Moditen (Fluphenazine Hydrochloride) C Date:03/22/02ISR Number: 3886275-6Report Type:Expedited (15-DaCompany Report #EMADSS2002001871 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Oedema Risperdal PS ORAL Initial or Prolonged Date:03/22/02ISR Number: 3886277-XReport Type:Expedited (15-DaCompany Report #EMADSS2002001871 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Oedema Risperdal PS ORAL Initial or Prolonged 22-Feb-2006 08:20 AM Page: 1229 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/22/02ISR Number: 3887558-6Report Type:Expedited (15-DaCompany Report #A205753 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Health Vistaril Capsules PS Intervention to Professional Ziprasidone SS Prevent Permanent Company Risperidal SS Impairment/Damage Representative Paxil SS Tenormin (Atenolol) C Hydrochlorothiazide C Lescol (Fluvastatin) C Zocor (Simvastatin) C Date:03/22/02ISR Number: 3888068-2Report Type:Expedited (15-DaCompany Report #EMADSS2002001797 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Foreign Risperdal (1 Mg Life-Threatening Bronchospasm Health Tablet) Vomiting Professional (Risperidone) PS ORAL 2 MG, DAILY, ORAL Depamide (Valpromide) C Serevent (Salmeterol Xinafoate) C Ventoline (Salbutamol) C Zyrtec (Cetrizine Hydrochloride) C Date:03/22/02ISR Number: 3888071-2Report Type:Expedited (15-DaCompany Report #EMADSS2002001216 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lymphocyte Count Foreign Risperdal Decreased Health (Unspecified) Neutrophil Count Professional (Risperidone) PS 0.5 MG DAILY Decreased Clonidine White Blood Cell Count (Clonidine) C Decreased Sulpiride (Sulpiride) C Date:03/24/02ISR Number: 3887628-2Report Type:Expedited (15-DaCompany Report #FR8931615MAR2002 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bronchitis Acute Viral Health Effexor Lp Disease Recurrence Professional (Venlafacine Hallucination Hydrochloride, Neutropenia Unspec) PS ORAL 75 MG 1X PER White Blood Cell Count 1 DAY ORAL Decreased Risperdal (Risperidone, , 0) SS ORAL ORAL Moditen (Fluphenazine Hydrochloride), 10 Drops Daily C 22-Feb-2006 08:20 AM Page: 1230 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/02ISR Number: 3887176-XReport Type:Expedited (15-DaCompany Report #NSADSS2002008910 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Risperdal PS ORAL Initial or Prolonged Date:03/25/02ISR Number: 3887235-1Report Type:Expedited (15-DaCompany Report #APCDSS2002000190 Age:1 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Risperidone PS INTRA-UTERINE Initial or Prolonged Convulsion Neonatal Clomipramine Foetal Distress Syndrome Hydrochloride SS INTRA-UTERINE Grand Mal Convulsion Trihexyphenidyl Hyperbilirubinaemia Hydrochloride SS INTRA-UTERINE Infection Maternal Drugs Affecting Foetus Neonatal Apnoeic Attack Premature Baby Transient Tachypnoea Of The Newborn Date:03/25/02ISR Number: 3888700-3Report Type:Expedited (15-DaCompany Report #EMADSS2002001871 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Oedema Foreign Risperdal (Solution) Initial or Prolonged Health (Risperidone) PS 2 DOSE ONLY Professional Date:03/25/02ISR Number: 3888702-7Report Type:Expedited (15-DaCompany Report #NSADSS2002009004 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Health Risperdal Initial or Prolonged Decreased Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:03/25/02ISR Number: 3888907-5Report Type:Expedited (15-DaCompany Report #HQ1420421MAR2002 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Health Tavor (Lorazepam, First Degree Professional Tablet) PS ORAL 1 TABLET Bradycardia DAILY Risperidone (Risperidone, ) SS ORAL 3.5 TABLET DAILY Date:03/25/02ISR Number: 3889078-1Report Type:Expedited (15-DaCompany Report #11770997 Age: Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:20 AM Page: 1231 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Disability PT Report Source Product Role Manufacturer Route Dose Duration Diabetic Ketoacidosis Foreign Zerit Caps Hyperlipidaemia Literature (Stavudine) PS ORAL 60 MILLIGRAM, Liver Function Test Health 1 DAY ORAL Abnormal Professional Akineton (Biperiden Company Lactate) SS ORAL 2 MILLIGRAM, Representative 1 DAY ORAL Other Risperdal (Risperidone) SS ORAL 5 MILLIGRAM, 1 DAY ORAL Methylcobalamin (Hydroxocobalamin) SS ORAL 1.5 GRAM, 1 DAY ORAL Proheparum SS ORAL 3 DOSAGE FORM, 1 DAY ORAL Zyloric (Allopurinol) SS ORAL 200 MILLIGRAM, 1 DAY ORAL Epivir (Lamivudine) SS ORAL 300 MILLIGRAM, 1 DAY ORAL Crixivan (Indinavir Sulfate) SS ORAL 2.4 GRAM, 1 DAY ORAL Diflucan (Fluconazole) SS ORAL 200 MILLIGRAM, 1 DAY ORAL Kogenate (Factor Viii) C Date:03/26/02ISR Number: 3888000-1Report Type:Expedited (15-DaCompany Report #EMADSS2002001824 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Risperdal PS UNKNOWN Life-Threatening Sodium Valproate SS UNKNOWN Risperdal C UNKNOWN Date:03/26/02ISR Number: 3889143-9Report Type:Expedited (15-DaCompany Report #NSADSS2002008910 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Health Risperdal Initial or Prolonged Professional (Unspecified) (Risperidone) PS OVERDOSE NOS Date:03/26/02ISR Number: 3889955-1Report Type:Expedited (15-DaCompany Report #APCDSS2002000190 Age:1 DY Gender:Female I/FU:F Outcome PT Hospitalization - Caesarean Section Initial or Prolonged Convulsion Neonatal Drug Ineffective 22-Feb-2006 08:20 AM Page: 1232 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Foetal Distress Syndrome Hyperbilirubinaemia Neonatal Report Source Product Role Manufacturer Route Dose Duration Maternal Drugs Affecting Foreign Risperidone Foetus Health (Unspecified) Neonatal Disorder Professional (Risperidone) PS INTRA-UTERINE MG, UTERINE Premature Baby Clomipramine Sleep Apnoea Syndrome Hydrochloride Transient Tachypnoea Of (Clomipramine The Newborn Hydrochloride) SS INTRA-UTERINE TABLE, Twin Pregnancy UTERINE Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) SS INTRA-UTERINE MG, UTERINE Date:03/27/02ISR Number: 3888775-1Report Type:Expedited (15-DaCompany Report #NSADSS2002009180 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:03/27/02ISR Number: 3888800-8Report Type:Expedited (15-DaCompany Report #EMADSS2002001902 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal PS ORAL Hospitalization - Parkinsonism Taxilan C UNKNOWN Initial or Prolonged Digitoxin C UNKNOWN Verapamil C UNKNOWN Delix C UNKNOWN Xipamid C UNKNOWN Date:03/27/02ISR Number: 3888811-2Report Type:Expedited (15-DaCompany Report #NSADSS2002005931 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Risperdal PS ORAL Date:03/27/02ISR Number: 3888980-4Report Type:Expedited (15-DaCompany Report #EMADSS2002001975 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Risperdal PS UNKNOWN Initial or Prolonged Hyperpyrexia Topamax SS UNKNOWN Hypotension Risperdal C UNKNOWN Epanutin C UNKNOWN Tegretol C UNKNOWN Serenance C UNKNOWN Atarax C UNKNOWN Valium C UNKNOWN 22-Feb-2006 08:20 AM Page: 1233 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/27/02ISR Number: 3889006-9Report Type:Expedited (15-DaCompany Report #NSADSS2002009182 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:03/27/02ISR Number: 3889007-0Report Type:Expedited (15-DaCompany Report #EMADSS2002001936 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Risperdal PS ORAL 1 YR Initial or Prolonged Bradycardia Dipiperon SS ORAL 1 YR Confusional State Date:03/27/02ISR Number: 3890857-5Report Type:Expedited (15-DaCompany Report #EMADSS2002001824 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Foreign Risperidal Life-Threatening Health (Risperidone) PS 1 MG, 2 IN 1 Professional DAY (S); 3 MG, 2 IN 1 DAILY Sodium Valproate (Valproate Sodium) SS 500 MG, 2 IN 1 DAILY Date:03/27/02ISR Number: 3890860-5Report Type:Expedited (15-DaCompany Report #11770997 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Foreign Zerit Caps Hospitalization - Diabetic Ketoacidosis Literature (Stavudine) PS ORAL 60 MILLIGRAM, Initial or Prolonged Hyperlipidaemia Company 1 DAY ORAL Disability Insulin Resistance Representative Akineton (Biperiden Liver Function Test Lactate) SS ORAL 2 MILLIGRAM, Abnormal 1 DAY ORAL Risperdal (Risperidone) SS ORAL 5 MILLIGRAM, 1 DAY ORAL Methylcobalamin (Hydroxocobalamin) SS ORAL 1.5 GRAM, 1 DAY ORAL Proheparum SS ORAL 3 DOSAGE FORM, 1 DAY ORAL Zyloric (Allopurinol) SS ORAL 200 MILLIGRAM, 1 DAY ORAL Epivir (Lamivudine) SS ORAL 300 MILLIGRAM, 1 DAY ORAL Crixivan (Indinavir Sulfate) SS ORAL 2.4 GRAM, 1 DAY ORAL Diflucan (Fluconazole) SS ORAL 200 MILLIGRAM, 1 22-Feb-2006 08:20 AM Page: 1234 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY ORAL Kogenate (Factor Viii) C Date:03/28/02ISR Number: 3890093-2Report Type:Expedited (15-DaCompany Report #NSADSS2001027377 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:03/28/02ISR Number: 3890094-4Report Type:Expedited (15-DaCompany Report #NSADSS2002009381 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:03/28/02ISR Number: 3890114-7Report Type:Expedited (15-DaCompany Report #NSADSS2002009379 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:03/28/02ISR Number: 3890124-XReport Type:Expedited (15-DaCompany Report #NSADSS2002009804 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:03/28/02ISR Number: 3890126-3Report Type:Expedited (15-DaCompany Report #NSADSS2002009626 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:03/28/02ISR Number: 3892112-6Report Type:Expedited (15-DaCompany Report #EMADSS2002001902 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Risperdal (1 Mg Hospitalization - Parkinsonism Health Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY (S), ORAL Taxilan (Perazine) SS Digitoxin (Digitoxin) C Verapamil (Verapamil) C Delix (Ramipril) C Xipamid (Xipamide) C 22-Feb-2006 08:20 AM Page: 1235 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/02ISR Number: 3892114-XReport Type:Expedited (15-DaCompany Report #EMADSS2002001936 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apnoea Foreign Risperdal (1mg/Ml Initial or Prolonged Bradycardia Health Solution) Confusional State Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY (S), ORAL Dipiperon (Unspecified) (Pipamperone) SS ORAL ORAL Date:03/28/02ISR Number: 3892149-7Report Type:Expedited (15-DaCompany Report #EMADSS2002001975 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal Initial or Prolonged Hypotension Health (Unspecified) Hypothermia Professional (Risperidone) PS Topamax (Topiramate) SS Epanutin (Phenytoin Sodium) C Tegretol (Carbamazepine) C Serenance (Haloperidol) C Atarax (Hydroxyzine Hydrochloride) C Valium (Diazepam) C Date:03/28/02ISR Number: 3892247-8Report Type:Expedited (15-DaCompany Report #NSADSS2002005931 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL 2 MG, 1 IN 1 DAY (S), ORAL Date:03/28/02ISR Number: 3892248-XReport Type:Expedited (15-DaCompany Report #NSADSS2002009182 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (0.5 Mg Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Date:03/28/02ISR Number: 3892249-1Report Type:Expedited (15-DaCompany Report #NSADSS2002009180 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL 3 MG, 2 IN 1 DAILY; ORAL 22-Feb-2006 08:20 AM Page: 1236 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/02ISR Number: 3890954-4Report Type:Expedited (15-DaCompany Report #NSADSS2002009800 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS ORAL Professional Date:03/29/02ISR Number: 3891367-1Report Type:Expedited (15-DaCompany Report #APCDSS2002000190 Age:1 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Risperidone PS INTRA-UTERINE 7 DAY Initial or Prolonged Caesarean Section Clomipramine Clonic Convulsion Hydrochloride SS INTRA-UTERINE 8 DAY Convulsion Neonatal Trihexyphenidyl Foetal Distress Syndrome Hydrochloride SS INTRA-UTERINE 7 DAY Hyperbilirubinaemia Neonatal Infection Maternal Drugs Affecting Foetus Neonatal Apnoeic Attack Premature Baby Sleep Apnoea Syndrome Transient Tachypnoea Of The Newborn Date:03/29/02ISR Number: 3891415-9Report Type:Expedited (15-DaCompany Report #NSADSS2002009808 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Failure Risperdal PS ORAL Congestive Cardiomyopathy Viral Infection Date:03/29/02ISR Number: 3891418-4Report Type:Expedited (15-DaCompany Report #NSADSS2002009796 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Platelet Count Decreased Risperdal PS ORAL Date:04/01/02ISR Number: 3892093-5Report Type:Expedited (15-DaCompany Report #NSADSS2002004781 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Atrial Flutter Risperdal PS ORAL Cardiomyopathy Clozapine SS ORAL Coronary Artery Disease Date:04/01/02ISR Number: 3892094-7Report Type:Expedited (15-DaCompany Report #NSADSS2001008399 Age:48 YR Gender:Female I/FU:F Outcome PT Death Akathisia Alanine Aminotransferase Increased 22-Feb-2006 08:20 AM Page: 1237 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspartate Aminotransferase Increased Report Source Product Role Manufacturer Route Dose Duration Blood Lactate Risperdal PS ORAL 25 DAY Dehydrogenase Increased Quetiapine SS ORAL 1 DAY Cardio-Respiratory Arrest Risperdal C ORAL 503 DAY Choking Risperdal C ORAL 38 DAY Dyskinesia Risperdal C ORAL 7 DAY Hallucination, Auditory Risperdal C ORAL 7 DAY Hypoaesthesia Quetiapine C ORAL 2 DAY Nasopharyngeal Disorder Quetiapine C ORAL 3 DAY Neck Pain Quetiapine C ORAL 2 DAY Obstruction Estazolam C ORAL 559 DAY Restlessness Flunitrazepam C ORAL 609 DAY Tremor Biperiden Hydrochloride C ORAL 69 DAY Quetiapine C ORAL 1 DAY Quetiapine C ORAL 1 DAY Quetiapine C ORAL 1 DAY Risperdal C ORAL 4 DAY Risperdal C ORAL 3 DAY Risperdal C ORAL 4 DAY Risperdal C ORAL 10 DAY Risperdal C ORAL 4 DAY Date:04/01/02ISR Number: 3892099-6Report Type:Expedited (15-DaCompany Report #NSADSS2002006236 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hip Fracture Risperdal PS ORAL 1 YR Date:04/01/02ISR Number: 3892108-4Report Type:Expedited (15-DaCompany Report #NSADSS2002006263 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL 42 DAY Pepcid C ORAL Elavil C UNKNOWN Effexor C UNKNOWN Date:04/01/02ISR Number: 3892109-6Report Type:Expedited (15-DaCompany Report #NSADSS2002006991 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Risperdal PS ORAL Date:04/01/02ISR Number: 3892118-7Report Type:Expedited (15-DaCompany Report #NSADSS2002010227 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL 22-Feb-2006 08:20 AM Page: 1238 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/02ISR Number: 3892127-8Report Type:Expedited (15-DaCompany Report #NSADSS2002009995 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:04/01/02ISR Number: 3892769-XReport Type:Direct Company Report #CTU 164679 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Risperdal 0.5mg Joint Stiffness (Janssen) PS Janseen 0.5MG 0.25MG Depakote C Paxil C Docusate Sodium C Date:04/01/02ISR Number: 3893259-0Report Type:Direct Company Report #CTU 164707 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fracture Of Penis Risperdal 1mg Po Initial or Prolonged Penile Pain Bid PS ORAL 1MG PO BID Disability Penile Swelling Risperdal SS 0.5 MG BID Priapism Date:04/01/02ISR Number: 3893542-9Report Type:Expedited (15-DaCompany Report #NSADSS2002009796 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Consumer Risperdal (1 Mg Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY (S), ORAL Date:04/01/02ISR Number: 3893550-8Report Type:Expedited (15-DaCompany Report #APCDSS2002000190 Age:1 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Risperidone(Risperid Initial or Prolonged Clonic Convulsion Health one) PS MG, UTERINE Convulsion Neonatal Professional Clomipramine Foetal Distress Syndrome Hydrochloride(Clomip Hyperbilirubinaemia ramine Neonatal Hydrochloride) SS TABLE, DAILY, Maternal Drugs Affecting UTERINE Foetus Trihexyphenidyl Neonatal Disorder Hydrochloride(Trihex Neonatal Infection yphenidyl Premature Baby Hydrochloride) SS TRANSPLACENTAL MG, DAILY, Sleep Apnoea Syndrome UTERINE Small For Dates Baby Transient Tachypnoea Of The Newborn 22-Feb-2006 08:20 AM Page: 1239 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/02ISR Number: 3893594-6Report Type:Expedited (15-DaCompany Report #NSADSS2002009800 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, 2 IN 24 HOUR(S), ORAL Date:04/01/02ISR Number: 3893595-8Report Type:Expedited (15-DaCompany Report #NSADSS2002009808 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Risperdal (0.5 Mg Congestive Professional Tablet) Left Ventricular Failure (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Date:04/02/02ISR Number: 3892832-3Report Type:Expedited (15-DaCompany Report #NSADSS2002010349 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:04/02/02ISR Number: 3892834-7Report Type:Expedited (15-DaCompany Report #NSADSS2002010350 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:04/02/02ISR Number: 3893031-1Report Type:Expedited (15-DaCompany Report #WAES 0203DEU00242 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Vasotec PS Merck & Co., Inc ORAL 2 MON Initial or Prolonged Confusional State Piretanide SS ORAL 2 MON Dehydration Metoprolol Succinate SS ORAL 2 MON Sinus Tachycardia Digitoxin SS ORAL 2 MON Isosorbide Dinitrate SS ORAL 2 MON Risperdal SS ORAL Lormetazepam SS ORAL 2 MON Aspirin C ORAL 2 MON Molsidomine C ORAL 2 MON Clopidogrel Bisulfate C ORAL Date:04/02/02ISR Number: 3893742-8Report Type:Expedited (15-DaCompany Report #NSADSS2002006991 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 1240 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/02ISR Number: 3893743-XReport Type:Expedited (15-DaCompany Report #NSADSS2002006236 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hip Fracture Consumer Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:04/02/02ISR Number: 3893786-6Report Type:Expedited (15-DaCompany Report #NSADSS2002010227 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Tablet) (Risperidone) PS ORAL ORAL Date:04/02/02ISR Number: 3893787-8Report Type:Expedited (15-DaCompany Report #NSADSS2002009995 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) Risperidone PS ORAL ORAL Date:04/02/02ISR Number: 3893980-4Report Type:Expedited (15-DaCompany Report #NSADSS2002006263 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 0.5 MG, 1 IN 1 NIGHT(S), ORAL Pepcid (Famotidine) C Elavil (Amitriptyline Hydrochloride) C Effexor (Venlafaxine Hydrochloride) C Date:04/02/02ISR Number: 3894199-3Report Type:Expedited (15-DaCompany Report #NSADSS2001008399 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Risperdal (Tablet) Increased Health (Risperidone) PS ORAL SEE IMAGE Aspartate Professional Quetiapine Aminotransferase (Quetiapine) SS ORAL SEE IMAGE Increased Biperiden Blood Lactate Hydrochloride Dehydrogenase Increased (Biperiden Cardio-Respiratory Arrest Hydrochloride) C Choking Flunitrazepam Dyskinesia (Flunitrazepam) C Hallucination, Auditory Estazolam Hypoaesthesia (Estazolam) C Neck Pain Restlessness Tremor 22-Feb-2006 08:20 AM Page: 1241 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/02ISR Number: 3894200-7Report Type:Expedited (15-DaCompany Report #NSADSS2002004781 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Flutter Foreign Risperdal (Tablet) Cardiomyopathy Health (Risperidone) PS ORAL 2 MG, ORAL Eosinophilic Pneumonia Professional Clozapine Company (Clozapine) SS ORAL ORAL Representative Date:04/03/02ISR Number: 3893670-8Report Type:Expedited (15-DaCompany Report #NSADSS2002010572 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:04/03/02ISR Number: 3893671-XReport Type:Expedited (15-DaCompany Report #NSADSS2002005761 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Cancer Risperdal PS ORAL 233 DAY Other Galactorrhoea Risperdal C ORAL 393 DAY Menstruation Irregular Zoloft C ORAL Date:04/03/02ISR Number: 3893684-8Report Type:Expedited (15-DaCompany Report #NSADSS2002010933 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:04/03/02ISR Number: 3893691-5Report Type:Expedited (15-DaCompany Report #NSADSS2002010351 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:04/03/02ISR Number: 3894227-5Report Type:Expedited (15-DaCompany Report #A205753 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Health Vistaril Capsules PS Intervention to Professional Ziprasidone SS Prevent Permanent Company Risperidal SS Impairment/Damage Representative Paxil SS Tenormin (Atenolol) C Hydrochlorothiazide C Lescol (Fluvastatin) C Zocor (Simvastatin) C Date:04/03/02ISR Number: 3894281-0Report Type:Expedited (15-DaCompany Report #NSADSS2002010349 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1242 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/03/02ISR Number: 3894286-XReport Type:Expedited (15-DaCompany Report #NSADSS2002010350 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, DAILY, ORAL Date:04/03/02ISR Number: 3894348-7Report Type:Expedited (15-DaCompany Report #FLUV00302000796 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Clonic Convulsion Literature Fluvoxamine Initial or Prolonged Coma (Fluvoxamine Confusional State Maleate) PS DAILY Diarrhoea Risperidone Hyperhidrosis (Risperidone) SS DAILY Hyperreflexia Muscle Rigidity Neurotoxicity Pyrexia Date:04/03/02ISR Number: 3895360-4Report Type:Expedited (15-DaCompany Report #EMADSS2002001871 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Oedema Foreign Risperdal (Solution) Initial or Prolonged Health (Risperidone) PS 2 DOSES ONLY Professional Date:04/03/02ISR Number: 3895365-3Report Type:Expedited (15-DaCompany Report #EMADSS2002001975 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Topamax Initial or Prolonged Hypotension Health (Topiramate) PS Hypothermia Professional Risperdal (Risperidone) SS Epanutin C Tegretol C Serenance C Atarax C Valium C Date:04/03/02ISR Number: 3895421-XReport Type:Expedited (15-DaCompany Report #B0262688A Age:36 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Triglycerides Initial or Prolonged Increased Disability Diabetes Mellitus Required Diabetes Mellitus Intervention to Inadequate Control Prevent Permanent Enzyme Abnormality Impairment/Damage Gallbladder Disorder Glucose Tolerance Impaired 22-Feb-2006 08:20 AM Page: 1243 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatic Enzyme Increased Ketosis Report Source Product Role Manufacturer Route Dose Duration Foreign Epivir Tablet Literature (Lamivudine) PS ORAL 150 MG TWICE Health PER DAY/ORAL Professional Allopurinol Tablet (Allopurinol) SS ORAL 100 MG TWICE PER DAY/ORAL Indinavir Sulfate (Indinavir Sulfate) SS ORAL 800 MG THREE TIMES PER DAY/ORAL Stavudine (Stavudine) SS ORAL 30 MG/TWICE PER DAY/ORAL Risperidone (Risperidone) SS ORAL 2.5 MG/PER DAY/ORAL Akineton (Akineton) SS ORAL 2 MG/PER DAY/ORAL Fluconazole Capsule (Fluconazole) SS ORAL 200 MG/PER DAY/ORAL Mecobalamin Tablet (Mecobalamin) SS ORAL 500 MG THREE TIMES PER DAY/ORAL Proheparum Tablet (Proheparum) SS ORAL ORAL Factor Viii Fraction C Date:04/04/02ISR Number: 3895693-1Report Type:Expedited (15-DaCompany Report #NSADSS2002010572 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:04/04/02ISR Number: 3895694-3Report Type:Expedited (15-DaCompany Report #NSADSS2002010351 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, 1 IN 1 NIGHT (S), ORAL Date:04/04/02ISR Number: 3895698-0Report Type:Expedited (15-DaCompany Report #NSADSS2002010933 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, 2 IN DAILY,ORAL 22-Feb-2006 08:20 AM Page: 1244 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/02ISR Number: 3895710-9Report Type:Expedited (15-DaCompany Report #NSADSS2002005761 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Prolactin Increased Health Risperdal Required Breast Cancer Female Professional (Unspecified) Intervention to Breast Discharge Company (Risperidone) PS ORAL 0.5 MG, 1 IN Prevent Permanent Galactorrhoea Representative 1 DAILY, ORAL Impairment/Damage Menstruation Irregular Zoloft (Sertraline Hydrochloride) C Date:04/04/02ISR Number: 3896041-3Report Type:Direct Company Report #CTU 165044 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Risperdal 4mg Hyperhidrosis Janssen PS Janssen ORAL 2 MG BEDTIME ORAL Clonazepam C Mevacor C Acyclovir C Date:04/04/02ISR Number: 3896196-0Report Type:Expedited (15-DaCompany Report #B0262688A Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Proheparum Tablet Initial or Prolonged Diabetic Ketoacidosis Literature (Proheparum) PS ORAL ORAL Disability Enzyme Abnormality Health Allopurinol Tablet Required Gallbladder Disorder Professional (Allopurinol) SS ORAL 100 MG / Intervention to Glucose Tolerance TWICE PER DAY Prevent Permanent Impaired / ORAL Impairment/Damage Hepatic Enzyme Increased Indinavir Sulfate Lipids Increased (Formulation Pancytopenia Unknown) (Indinavir Sulfate) SS ORAL 800 MG / THREE TIMES PER DAY / ORAL Risperidone (Formulation Unknown) (Risperidone) SS ORAL 2.5 MG / PER DAY / ORAL Fluconazole Capsule (Fluconazole) SS ORAL 200 MG / PER DAY / ORAL Proheparum Tablet (Proheparum) SS ORAL ORAL Mecobalamin Tablet (Mecobalamin) SS ORAL 500 MG / THREE TIMES PER DAY / ORAL Akineton (Formulation Unknown) (Akineton) SS ORAL 2 MG / PER DAY / ORAL Stavudine (Formulation 22-Feb-2006 08:20 AM Page: 1245 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unknown) (Stavudine) SS ORAL 30 MG / TWICE PER DAY / ORAL Lamivudine Tablet (Lamivudine) C ORAL 150 MG TWICE PER DAY / ORAL Factor Viii Fraction C Date:04/05/02ISR Number: 3895006-5Report Type:Expedited (15-DaCompany Report #EMADSS2002001540 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Risperdal PS ORAL Eunerpan C UNKNOWN Valprolept C UNKNOWN Date:04/05/02ISR Number: 3895007-7Report Type:Expedited (15-DaCompany Report #APCDSS2001001352 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Breast Neoplasm Risperdal PS ORAL 3 YR Other Cardiovascular Disorder Brotizolam C ORAL Pigmentation Disorder Lormetazepam C ORAL Stasis Dermatitis Sennoside C UNKNOWN Urticaria Date:04/05/02ISR Number: 3896591-XReport Type:Expedited (15-DaCompany Report #FLUV00302000457 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Congenital Anomaly Foreign Depromel Taken By Lissencephaly Health Mother (Fluvoxamine Maternal Drugs Affecting Professional Maleate0 PS SEE IMAGE Foetus Other Risperdal Taken By Porencephaly Mother (Risperidone0 SS 1 MG DAILY PL Depas Taken By Mother (Etitolam) SS SEE IMAGE Kamishouyousan C Seroquel (Seroquel) C Ferromia (Ferrous Citrate) C Vitamedin (Pyroxidine) C Aftach (Triamcinolone Acetonide) C Date:04/05/02ISR Number: 3896779-8Report Type:Expedited (15-DaCompany Report #A202900 Age:33 YR Gender:Female I/FU:I Outcome PT Required Amenorrhoea Intervention to Anxiety Prevent Permanent Depression Impairment/Damage Mood Altered Neutrophil Count Decreased 22-Feb-2006 08:20 AM Page: 1246 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Red Blood Cell Count Decreased Tearfulness Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Health Zoloft Tablets PS ORAL 200.00 MG Decreased Professional TOTAL;DAILY;O RAL Neurontin SS ORAL 1600.00 MG TOTAL;BID;ORA L Risperdal SS 2.00 MG TOTAL;DAILY Xanax C Depakote C Benadryl C Date:04/05/02ISR Number: 3898215-4Report Type:Direct Company Report #CTU 165143 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Olanzapine PS SEE #5 (LAST Increased DOSAGES PM MEDS DAY BEFORE HE WAS FOUND) Risperdol SS SEE #5 (LAST DOSAGES PM MEDS DAY BEFORE HE WAS FOUND) Date:04/08/02ISR Number: 3896747-6Report Type:Expedited (15-DaCompany Report #NSADSS2002011264 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:04/08/02ISR Number: 3896750-6Report Type:Expedited (15-DaCompany Report #NSADSS2002010934 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:04/08/02ISR Number: 3896843-3Report Type:Expedited (15-DaCompany Report #02P-163-0190536-00 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Depakote (Divalproex Initial or Prolonged Weight Increased Professional Sodium) (Divalproex Company Sodium) PS ORAL 1175 MG, 1 IN Representative 1 D, PER ORAL Risperidone SS Clozapine C 22-Feb-2006 08:20 AM Page: 1247 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/02ISR Number: 3896898-6Report Type:Expedited (15-DaCompany Report #NSADSS2002010934 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:04/08/02ISR Number: 3897320-6Report Type:Expedited (15-DaCompany Report #APCDSS2001001352 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Breast Neoplasm Foreign Risperdal (1 Mg Required Pigmentation Disorder Health Tablet) Intervention to Poor Peripheral Professional (Risperidone) PS ORAL MG, DAILY, Prevent Permanent Circulation ORAL Impairment/Damage Rash Brotizolam Stasis Dermatitis (Brotizolam) C Urticaria Lormetazepam (Lormetazepam) C Sennoside (Sennosides) C Date:04/08/02ISR Number: 3897321-8Report Type:Expedited (15-DaCompany Report #EMADSS2002001540 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 3 MG, DAILY, ORAL Eunerpan (Melperone Hydrochloride) C Valprolept (Valproate Sodium) C Date:04/08/02ISR Number: 3897373-5Report Type:Expedited (15-DaCompany Report #WAES 0203DEU00242 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Decreased Foreign Tab Vasotec Initial or Prolonged Confusional State Health (Enalapril Maleate) PS ORAL 2.5 MG/DAILY, Dehydration Professional PO 2 MON Sinus Tachycardia Other Tab Piretanide SS ORAL 3 MG/DAILY, PO 2 MON Tab Cr Metoprolol Succinate SS ORAL 95 MG/DAILY, PO 2 MON Tab Digitoxin SS ORAL 0.07 MG/DAILY, PO 2 MON Cap Isosorbide Dinitrate SS ORAL 120 MG/DAILY, PO 2 MON Tab Lormetazepam SS ORAL 1 MG/DAILY, PO 2 MON Tab Risperdal (Risperidone) SS ORAL 3 MG/DAILY, PO 2 MON Aspirin C 22-Feb-2006 08:20 AM Page: 1248 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clopidogrel Bisulfate C Molsidomine C Date:04/09/02ISR Number: 3896263-1Report Type:Expedited (15-DaCompany Report #EMADSS2002002216 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Risperdal PS ORAL Initial or Prolonged Syncope Adocor SS ORAL Blocotenol SS ORAL Diurapid SS ORAL Liprevil SS ORAL Ossofortin C UNKNOWN Date:04/09/02ISR Number: 3897934-3Report Type:Expedited (15-DaCompany Report #2002AP00556 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abdominal Distension Foreign Seroquel PS ORAL 75 MG DAILY Intervention to Flatulence Health PO Prevent Permanent Gastrointestinal Motility Professional Seroquel SS ORAL 150 MG DAILY Impairment/Damage Disorder Other PO Intestinal Dilatation Seroquel SS ORAL 75 MG DAILY Nausea PO Somnolence Risperdal SS ORAL 3 MG DAILY PO Vomiting Tasmolin SS ORAL 3 MG DAILY PO Zyprexa SS ORAL 10 MG DAILY PO Levotomin SS ORAL 20 MG DAILY PO Depas C Sennoside C Pantosin C No Match C Gascon C Magnesium Oxide C Date:04/09/02ISR Number: 4365693-6Report Type:Expedited (15-DaCompany Report #EMADSS2002001540 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Risperdal PS ORAL Eunerpan C UNKNOWN Valprolept C UNKNOWN Date:04/09/02ISR Number: 4365695-XReport Type:Expedited (15-DaCompany Report #APCDSS2001001352 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Breast Neoplasm Risperdal PS ORAL 3 YR Other Oedema Peripheral Brotizolam C ORAL Skin Hyperpigmentation Lormetazepam C ORAL Stasis Dermatitis Sennoside C UNKNOWN 22-Feb-2006 08:20 AM Page: 1249 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/10/02ISR Number: 3896850-0Report Type:Expedited (15-DaCompany Report #NSADSS2002011610 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Risperdal PS ORAL Decreased Date:04/10/02ISR Number: 3896856-1Report Type:Expedited (15-DaCompany Report #NSADSS2002011392 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:04/10/02ISR Number: 3898030-1Report Type:Expedited (15-DaCompany Report #2002PK00317 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Beloc Zok PS ORAL 95 MG DAILY Initial or Prolonged Blood Glucose Decreased Health PO Required Confusional State Professional Arelix "Aventis Intervention to Creatine Phosphokinase Other Pharma" SS Aventis Pharma ORAL 3 MG DAILY PO Prevent Permanent Decreased Isoket Retard SS ORAL 120 MG DAILY Impairment/Damage Dehydration PO Haematocrit Decreased Digitoxin "Awd" SS ORAL 0.07 MG DAILY Haemoglobin Decreased PO White Blood Cell Count Noctamid-1 SS ORAL 1 MG DAILY, Decreased PO Kanef-Cor SS ORAL 2.5 MG DAILY, PO Risperdal SS ORAL 3 MG DAILY PO Ass "Hexal" C Corvation "Aventis Pharma" C Iscover C Date:04/10/02ISR Number: 3898394-9Report Type:Expedited (15-DaCompany Report #EMADSS2002002216 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Foreign Risperdal (1 Mg Initial or Prolonged Loss Of Consciousness Health Tablet) Syncope Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Adocor (Captopril) SS ORAL ORAL Blocotenol (Atenolol) SS ORAL 100 MG, DAILY, ORAL Diurapid (Furosemide) SS ORAL 40 MG, DAILY; ORAL Liprevil (Pravastatin Sodium) SS 10 MG, DAILY; ORAL Ossofortin (Ossofortin) C 22-Feb-2006 08:20 AM Page: 1250 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/10/02ISR Number: 3898442-6Report Type:Expedited (15-DaCompany Report #MK200203-0236-1 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Caesarean Section Foreign Anafranil PS Convulsion Neonatal Health Artane SS Foetal Distress Syndrome Professional Risperdal SS Maternal Drugs Affecting Foetus Neonatal Apnoeic Attack Premature Baby Small For Dates Baby Twin Pregnancy Date:04/10/02ISR Number: 3898457-8Report Type:Expedited (15-DaCompany Report #MK200204-0034-1 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Caesarean Section Foreign Anafranil PS Clonic Convulsion Health Artane SS Foetal Distress Syndrome Professional Risperdal SS Maternal Drugs Affecting Other Foetus Neonatal Apnoeic Attack Neonatal Disorder Premature Baby Small For Dates Baby Date:04/10/02ISR Number: 3898522-5Report Type:Expedited (15-DaCompany Report #NSADSS2002011265 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, DAILY, ORAL Lamictal (Lamotrigine) C Date:04/10/02ISR Number: 3899392-1Report Type:Direct Company Report #CTU 165448 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Risperdal PS Coma Lopressor SS Joint Stiffness Celexa C Date:04/10/02ISR Number: 3899547-6Report Type:Direct Company Report #CTU 165461 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Olanzapine PS SEE #5 (LAST Increased DOSAGES PRN MEDS DAY BEFORE HE WAS FOUND) Risperdol SS SEE #5 (LAST DOSAGES PRN 22-Feb-2006 08:20 AM Page: 1251 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report MEDS DAY BEFORE HE WAS FOUND) Date:04/11/02ISR Number: 3897446-7Report Type:Expedited (15-DaCompany Report #APCDSS2001001371 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Risperdal PS ORAL 14 DAY Schizophrenia Chlorpromazine Hydrochloride SS ORAL 916 DAY Quetiapine Fumarate SS ORAL 237 DAY Trihexyphenidyl Hydrochloride SS ORAL 916 DAY Flunitrazepam SS ORAL 916 DAY Teprenone SS ORAL 185 DAY Biperiden Hydrochloride SS ORAL 916 DAY Olanzapine SS ORAL 41 DAY Levomepromazine Maleate SS ORAL 721 DAY Diazepam SS ORAL 14 DAY Promethazine SS ORAL 83 DAY Nitrazepam SS ORAL 47 DAY Lorazepam SS ORAL 376 DAY L-Cysteine Ethylester Hydrocholoride SS ORAL 14 DAY Mosapramine SS ORAL 23 DAY Etizolam SS ORAL 93 DAY Impromen SS ORAL 501 DAY Risperdal C ORAL 28 DAY Risperdal C ORAL 14 DAY Risperdal C ORAL 14 DAY Risperdal C ORAL 9 DAY Risperdal C ORAL 306 DAY Risperdal C ORAL 28 DAY Risperdal C ORAL 14 DAY Risperdal C ORAL 14 DAY Levomepromazine Maleate C ORAL Flunitrazepam C ORAL Teprenone C ORAL Biperiden Hydrochloride C ORAL Trihexyphenidyl Hydrochloride C ORAL Olanzapine C ORAL Quetiapine Fumarate C ORAL Chlorpromazine Hydrochloride C ORAL Risperdal C ORAL 14 DAY Risperdal C ORAL 49 DAY Risperdal C ORAL 35 DAY Risperdal C ORAL 126 DAY Risperdal C ORAL 63 DAY Risperdal C ORAL 174 DAY Risperdal C ORAL 22-Feb-2006 08:20 AM Page: 1252 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/02ISR Number: 3897779-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11801404 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Liprevil PS Bristol-Myers Squibb Initial or Prolonged Syncope Company ORAL Adocor SS ORAL Blocotenol SS ORAL Blocotenol SS ORAL Diurapid SS ORAL Risperdal SS ORAL Date:04/11/02ISR Number: 3899133-8Report Type:Expedited (15-DaCompany Report #NSADSS2002011392 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 DAILY, ORAL Date:04/11/02ISR Number: 3899135-1Report Type:Expedited (15-DaCompany Report #NSADSS2002011610 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Consumer Risperdal Decreased (Unspecified) (Risperidone) PS ORAL 1 MG, 2 IN 1 DAILY, ORAL Date:04/12/02ISR Number: 3898889-8Report Type:Expedited (15-DaCompany Report #EMADSS2002002269 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Risperdal PS ORAL Initial or Prolonged Convulsion Professional Prozac C UNKNOWN Water Intoxication Xanax C UNKNOWN Date:04/12/02ISR Number: 3898911-9Report Type:Expedited (15-DaCompany Report #EMADSS2002001797 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Risperdal PS ORAL Life-Threatening Respiratory Arrest Professional Depamide C UNKNOWN Vomiting Serevent C UNKNOWN Ventoline C UNKNOWN Zyrtec C UNKNOWN Xanax C UNKNOWN Date:04/12/02ISR Number: 3898912-0Report Type:Expedited (15-DaCompany Report #APCDSS2002000319 Age:32 YR Gender:Male I/FU:I Outcome PT Hospitalization - Circulatory Collapse Initial or Prolonged Contusion Hyperpyrexia Hypothermia Paralysis 22-Feb-2006 08:20 AM Page: 1253 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Failure Acute Rhabdomyolysis Report Source Product Role Manufacturer Route Dose Duration Health Risperidone PS ORAL Professional Date:04/12/02ISR Number: 3899752-9Report Type:Expedited (15-DaCompany Report #NSADSS2002011525 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:04/12/02ISR Number: 3899753-0Report Type:Expedited (15-DaCompany Report #NSADSS2002011528 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:04/12/02ISR Number: 3900065-7Report Type:Expedited (15-DaCompany Report #A0363979A Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Toxicity Literature Paroxetin Mental Status Changes Consumer Hydrochloride Murder (Paroxetine Hydrochloride) PS ORAL ORAL Risperidone (Risperidone) SS Date:04/12/02ISR Number: 3900144-4Report Type:Expedited (15-DaCompany Report #APCDSS2001001371 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Risperdal Fall Health (Risperidone) PS SEE IMAGE Schizophrenia Professional Impromen (Unspecified) (Bromperidol) SS VARYING DOSES FROM 6 TO 24 MG DAILY Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS VARYING DOSES FROM 25 TO 300 MG DAILY Biperiden Hydrochloride (Biperiden Hydrochloride) SS VARYING DOSES FROM 3 TO 6 MG DAILY Levomepromazine Maleate (Levomepromazine 22-Feb-2006 08:20 AM Page: 1254 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maleate) SS ORAL VARYING DOSE FROM 5 MG TO 50 MG DAILY, PO Olanzapine (Olanzapine) SS ORAL MG, DAILY, ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS VARYING DOSES FROM 50 TO 600 MG DAILY Lorazepam (Lorazepam) SS VARYING DOSES FROM 0.5 WHEN NECESSARY TO 3 MG DAILY Promethazine (Promethazine) SS ORAL MG, DAILY, ORAL Diazepam (Diazepam) SS ORAL MG, PRN, ORAL Nitrazepam (Nitrazepam) SS ORAL MG, DAILY, ORAL L-Cysteine Ethylester Hydrocholoride (L-Cysteine Ethylester, SS ORAL MG, DAILY, ORAL Flunitrazepam (Flunitrazepam) SS ORAL VARYING DOSE FROM 1 MG TO 4 MG DAILY, PO Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) SS VARYING DOSES FROM 4 TO 12 MG DAILY Teprenone (Teprenone) C VARYING DOSES FROM 150 TO 300 MG DAILY Etizolam (Etizolam) C ORAL MG, DAILY, ORAL Mosapramine (Mosapramine) C VARYING DOSES FROM 50 TO 150 MG DAILY Date:04/15/02ISR Number: 3901012-4Report Type:Expedited (15-DaCompany Report #A207147 Age: Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged Required Intervention to Prevent Permanent 22-Feb-2006 08:20 AM Page: 1255 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Blood Pressure Decreased Consumer Zoloft Tablets PS ORAL 50.00 MG Confusional State TOTAL: DAILY: Cyst ORAL Decreased Appetite Risperidal SS ORAL 1.00 MG Dizziness TOTAL: BID: Drooling ORAL Dysgeusia Cogentin C Fall Klonipin C Head Injury Hernia Hypoaesthesia Nausea Nervous System Disorder Nervous System Neoplasm Night Sweats Oesophageal Disorder Retching Speech Disorder Vision Blurred Vomiting Weight Decreased Date:04/15/02ISR Number: 3901118-XReport Type:Expedited (15-DaCompany Report #APCDSS2002000319 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Pulmonary Oedema Foreign Risperidone (Tablet) Initial or Prolonged Circulatory Collapse Health (Risperidone) PS ORAL ORAL Contusion Professional Disseminated Intravascular Coagulation Hypothermia Localised Oedema Paralysis Renal Failure Acute Rhabdomyolysis Date:04/15/02ISR Number: 3901119-1Report Type:Expedited (15-DaCompany Report #EMADSS2002001797 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Foreign Risperdal (1 Mg Life-Threatening Respiratory Arrest Health Tablet) Vomiting Professional (Risperidone) PS ORAL 2 MG, DAILY, ORAL Depamide (Valpromide) C Serevent (Salmeterol Xinafoate) C Ventoline (Salbutamol) C Zyrtec (Cetirizine Hydrochloride) C Xanax (Alprazolam) C 22-Feb-2006 08:20 AM Page: 1256 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/02ISR Number: 3901120-8Report Type:Expedited (15-DaCompany Report #EMADSS2002002269 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Risperdal PS ORAL 8 MG, DAILY, Initial or Prolonged Condition Aggravated Health ORAL Convulsion Professional Prozac (Fluoxetine Water Intoxication Hydrochloride) C Xanax (Alprazolam) C Date:04/15/02ISR Number: 3901121-XReport Type:Expedited (15-DaCompany Report #EMADSS2001004198 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Foreign Haldol (2 Mg Tablet) Initial or Prolonged Health (Haloperidol) PS ORAL 2 MG, 1 IN 1 Other Professional DAILY, ORAL Risperidone (2 Mg Tablet) (Risperidone) SS ORAL 2 MG, 1 IN 1 DAILY, ORAL Date:04/16/02ISR Number: 3901799-0Report Type:Expedited (15-DaCompany Report #NSADSS2002011736 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:04/16/02ISR Number: 3901801-6Report Type:Expedited (15-DaCompany Report #NSADSS2002011733 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:04/17/02ISR Number: 3902116-2Report Type:Expedited (15-DaCompany Report #11770997 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Increased Foreign Zerit Caps Hospitalization - Diabetic Ketoacidosis Literature (Stavudine) PS ORAL 60 MILLIGRAM, Initial or Prolonged Hyperlipidaemia Company 1 DAY ORAL Disability Insulin Resistance Representative Akineton (Biperiden Liver Function Test Lactate) SS ORAL 2 MILLIGRAM, Abnormal 1 DAY ORAL Risperdal (Risperidone) SS ORAL 5 MILLIGRAM, 1 DAY ORAL Methylcobalamin (Hydroxocobalamin) SS ORAL 1.5 GRAM, 1 DAY ORAL Proheparum SS ORAL 3 DOSAGE FORM, 1 DAY ORAL Zyloric 22-Feb-2006 08:20 AM Page: 1257 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Allopurinol) SS ORAL 200 MILLIGRAM, 1 DAY ORAL Epivir(Lamivudine) SS ORAL 300 MILLIGRAM, 1 DAY ORAL Crixivan (Indinavir Sulfate) SS ORAL 2.4 GRAM, 1 DAY ORAL Diflucan (Fluconazole) SS ORAL 200 MILLIGRAM, 1 DAY ORAL Kogenate (Factor Viii) C Date:04/18/02ISR Number: 3901427-4Report Type:Expedited (15-DaCompany Report #NSADSS2002003208 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Risperidone PS ORAL Cardiomegaly Meprobamate SS Drug Toxicity Carisoprodol SS Overdose Pulmonary Oedema Toxicologic Test Abnormal Date:04/18/02ISR Number: 3903253-9Report Type:Expedited (15-DaCompany Report #NSADSS2002011975 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS Date:04/19/02ISR Number: 3902043-0Report Type:Expedited (15-DaCompany Report #EMADSS2002002402 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Confusional State Risperdal PS ORAL Disorientation Risperdal C ORAL Hallucination, Visual Tercian C UNKNOWN Lepticur C UNKNOWN Date:04/19/02ISR Number: 3902045-4Report Type:Expedited (15-DaCompany Report #NSADSS2002012160 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:04/19/02ISR Number: 3902117-4Report Type:Expedited (15-DaCompany Report #NSADSS2002012921 Age:47 YR Gender:Male I/FU:I Outcome PT Hospitalization - Choking Initial or Prolonged Drug Effect Decreased Dyspnoea Hyperhidrosis 22-Feb-2006 08:20 AM Page: 1258 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Oedema Oedema Peripheral Report Source Product Role Manufacturer Route Dose Duration Pneumonia Duragesic PS TRANSDERMAL Pruritus Risperdal SS ORAL Vision Blurred Duragesic C TRANSDERMAL 9 MON Valium C ORAL Wellbutrin C ORAL Asa C ORAL Allopurinol C ORAL Albuterol C RESPIRATORY (INHALATION) Minitran C TRANSDERMAL Enolase C UNKNOWN Celebrex C ORAL Atarax C ORAL Protonix C ORAL Lopid C ORAL Flonase C NASAL Azmacort C RESPIRATORY (INHALATION) Adalatic C ORAL Sonata C ORAL Lipitor C ORAL Depakote C ORAL Nitrostat C ORAL Lortab C ORAL Date:04/19/02ISR Number: 3902263-5Report Type:Expedited (15-DaCompany Report #APCDSS2002000350 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eclampsia Risperdal PS ORAL 7 DAY Maternal Drugs Affecting Fluvoxamine Maleate C ORAL 35 DAY Foetus Fluvoxamine Maleate C ORAL 7 DAY Neonatal Disorder Clomipramine Hydrochloride C ORAL 42 DAY Clomipramine Hydrochloride C ORAL 8 DAY Trihexyphenidyl Hydrochloride C ORAL 7 DAY Date:04/19/02ISR Number: 3902268-4Report Type:Expedited (15-DaCompany Report #APCDSS2002000362 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Risperdal PS ORAL Biperiden Hydrochloride C ORAL Iron Compounds & Preparations C ORAL Date:04/19/02ISR Number: 3902271-4Report Type:Expedited (15-DaCompany Report #APCDSS2002000190 Age:1 DY Gender:Female I/FU:F Outcome PT Hospitalization - Caesarean Section Initial or Prolonged Complications Of Maternal 22-Feb-2006 08:20 AM Page: 1259 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Exposure To Therapeutic Drugs Convulsion Neonatal Developmental Delay Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Risperidone PS INTRA-UTERINE 7 DAY Foetal Disorder Clomipramine Foetal Distress Syndrome Hydrochloride SS INTRA-UTERINE 42 DAY Hyperbilirubinaemia Trihexyphenidyl Neonatal Hydrochloride SS INTRA-UTERINE 7 DAY Maternal Drugs Affecting Fluvoxamine SS INTRA-UTERINE 7 DAY Foetus Clomipramine Neonatal Apnoeic Attack Hydrochloride C INTRA-UTERINE 8 DAY Neonatal Infection Fluvoxamine C INTRA-UTERINE 35 DAY Phobia Premature Baby Sleep Apnoea Syndrome Transient Tachypnoea Of The Newborn Twin Pregnancy Date:04/19/02ISR Number: 3902279-9Report Type:Expedited (15-DaCompany Report #APCDSS2002000353 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Neonatal Risperidone PS INTRA-UTERINE 89 DAY Aspiration Carbamazepine C INTRA-UTERINE 89 DAY Bradycardia Biperiden C INTRA-UTERINE 89 DAY Cerebral Haemorrhage Cloxazolam C INTRA-UTERINE 89 DAY Neonatal Flunitrazepam C INTRA-UTERINE 51 DAY Convulsion Neonatal Vegetamin A C INTRA-UTERINE 38 DAY Drug Withdrawal Syndrome Vegetamin B C INTRA-UTERINE 89 DAY Neonatal Dysphagia Foetal Distress Syndrome Forceps Delivery Maternal Drugs Affecting Foetus Neonatal Disorder Perinatal Brain Damage Date:04/19/02ISR Number: 3902307-0Report Type:Expedited (15-DaCompany Report #APCDSS2002000366 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Risperidone PS ORAL Initial or Prolonged Dyskinesia Haloperidol SS UNKNOWN maximum dose Other Dystonia was 16 mg/day 6 YR Fall Mobility Decreased Opisthotonus Psychiatric Symptom Tardive Dyskinesia Treatment Noncompliance 22-Feb-2006 08:20 AM Page: 1260 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/19/02ISR Number: 3902308-2Report Type:Expedited (15-DaCompany Report #EMADSS2002001473 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Risperidone PS UNKNOWN Cardiac Failure Gastritis Hypertension Date:04/19/02ISR Number: 3903870-6Report Type:Expedited (15-DaCompany Report #2002-SW-00046SW Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Inguinal Hernia Other Viramune Tab 200 Mg Initial or Prolonged (Nevirapine) (Ta) (Nevirapine) PS ORAL 400 MG PO Risperdal (Risperidone) (Ta) SS ORAL PO Date:04/19/02ISR Number: 3903931-1Report Type:Expedited (15-DaCompany Report #NSADSS2002003208 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Health Risperidone (Tablet) Cardiomegaly Professional (Risperidone) PS ORAL 2 MG, 2 IN Drug Level Above Company DAILY, ORAL Therapeutic Representative Meprobamate Drug Toxicity (Meprobamate) SS Overdose Carisoprodol Pulmonary Oedema (Carisoprodol) SS Date:04/22/02ISR Number: 3904555-2Report Type:Expedited (15-DaCompany Report #A0363979A Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Literature Paroxetine Anger Health Hydrochloride Delusion Professional (Formulation Drug Toxicity Unknown) (Paroxetine Mental Impairment Hydrochloride) PS ORAL SEE DOSAGE Mental Status Changes TEXT/ORAL Murder Risperidone (Formulation Unknown) (Risperidone) SS Date:04/22/02ISR Number: 3904829-5Report Type:Expedited (15-DaCompany Report #NSADSS2002012921 Age:47 YR Gender:Male I/FU:I Outcome PT Hospitalization - Chest Pain Initial or Prolonged Drug Effect Decreased Dyspnoea Hyperhidrosis Nausea Oedema Oedema Peripheral Pneumonia 22-Feb-2006 08:20 AM Page: 1261 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pruritus Vision Blurred Report Source Product Role Manufacturer Route Dose Duration Consumer Duragesic (Patch) (Fentanyl) PS TRANSDERMAL 100 MCG/H, 1 IN 48 HOUR(S), TRANSD Risperdal (0.5 Mg Tablet) (Risperidone) SS ORAL 0.5 MG, 2 IN 24 HOUR(S), ORAL Allopurinol C Valium (Diazepam) C Wellbutrin (Amfebutamone) C Asa (Acetylsalicylic Acid) C Lipitor (Atorvastatin) C Depakote (Valproate Semisodium) C Nitrostat (Glyceryl Trinitrate) C Lortab (Vicodin) C Sonata (Zaleplon) C Adalatic C Albuterol (Salbutamol) C Azmacort (Triamcinolone Acetonide) C Minitran (Glyceryl Trinitrate) C Flonase (Fluticasone Propionate) C Lopid (Gemfibrozil) C Protonix (Pantoprazole) C Atarax (Hydroxyzine Hydrochloride) C Celebrex (Celecoxib) C Enolase C Date:04/22/02ISR Number: 3904830-1Report Type:Expedited (15-DaCompany Report #NSADSS2002012160 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:04/22/02ISR Number: 3905296-8Report Type:Direct Company Report #CTU 166397 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Risperidone PS ORAL 1 MG BID ORAL Initial or Prolonged Tongue Oedema 22-Feb-2006 08:20 AM Page: 1262 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/02ISR Number: 3905329-9Report Type:Expedited (15-DaCompany Report #EMADSS2002002402 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Risperdal Disorientation Health (Risperidone) PS ORAL SEE IMAGE Hallucination, Visual Professional Tercian (Cyamemazine) C Lepticur (Tropatepine Hydrochloride) C Date:04/22/02ISR Number: 3905331-7Report Type:Expedited (15-DaCompany Report #APCDSS2002000190 Age:1 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Risperidone Initial or Prolonged Complications Of Maternal Health (Risperidone) PS INTRA-UTERINE DAILY, Exposure To Therapeutic Professional UTERINE Drugs Clomipramine Convulsion Neonatal Hydrochloride Developmental Delay (Clomipramine Drug Ineffective Hydrochloride) SS URETHRAL TABLE, DAILY, Eclampsia UTERINE Foetal Distress Syndrome Trihexyphenidyl Hyperbilirubinaemia Hydrochloride Neonatal (Trihexyphenidyl Maternal Drugs Affecting Hydrochloride) SS INTRA-UTERINE DAILY, Foetus UTERINE Neonatal Apnoeic Attack Fluvoxamine Neonatal Infection (Fluvoxamine) SS INTRA-UTERINE DAILY, Premature Baby UTERINE Transient Tachypnoea Of The Newborn Date:04/22/02ISR Number: 3905334-2Report Type:Expedited (15-DaCompany Report #APCDSS2002000350 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Risperdal (Tablet) Exposure To Therapeutic Health (Risperidone) PS ORAL MG, DAILY, Drugs Professional ORAL Eclampsia Fluvoxamine Maleate Maternal Drugs Affecting (Fluvoxamine Foetus Maleate) C Neonatal Disorder Clomipramine Hydrochloride (Clomipramine Hydrochloride) C Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1263 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/02ISR Number: 3905337-8Report Type:Expedited (15-DaCompany Report #APCDSS2002000362 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal (Tablet) Health (Risperidone) PS ORAL DAILY, ORAL Professional Biperiden Hydrochloride (Biperiden Hydrlchloride) C Iron Compounds & Preparations (Iron) C Date:04/22/02ISR Number: 3905339-1Report Type:Expedited (15-DaCompany Report #APCDSS2002000353 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Foreign Risperidone Bradycardia Health (Risperidone) PS INTRA-UTERINE DAILY, Complications Of Maternal Professional UTERINE Exposure To Therapeutic Carbamazepine Drugs (Carbamazepine) C Drug Withdrawal Biperiden Convulsions (Biperiden) C Dysphagia Cloxazolam Foetal Disorder (Cloxazolam) C Foetal Distress Syndrome Flunitrazepam Forceps Delivery (Flunitrazepam) C Haemorrhage Intracranial Vegetamin A Maternal Drugs Affecting (Vegetamin A) C Foetus Vegetamin B Neonatal Disorder (Vegetamin B(R) C Perinatal Brain Damage Date:04/22/02ISR Number: 3905344-5Report Type:Expedited (15-DaCompany Report #EMADSS2002001473 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperidone Cardiac Failure Health (Risperidone) PS 0.5 MG, DAILY Gastritis Professional Hypertension Date:04/22/02ISR Number: 3905370-6Report Type:Direct Company Report #CTU 166390 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Rolling Risperdal 2.5mg PS ORAL 2.5MG2/DAY Movement Disorder ORAL Paxil C Date:04/23/02ISR Number: 3904615-6Report Type:Expedited (15-DaCompany Report #EMADSS2002000092 Age:66 YR Gender:Male I/FU:F Outcome PT Costovertebral Angle Tenderness Dysphagia 22-Feb-2006 08:20 AM Page: 1264 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Eructation Extrapyramidal Disorder Hyperhidrosis Report Source Product Role Manufacturer Route Dose Duration Malaise Risperdal PS ORAL 3 DAY Medication Error Plavix C ORAL Muscle Rigidity Selozok C ORAL Pharyngolaryngeal Pain Venlafaxine C ORAL Salivary Hypersecretion Lorazepam C ORAL Trazolan C ORAL Date:04/23/02ISR Number: 3905215-4Report Type:Direct Company Report #CTU 166456 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Risperdal PS Hospitalization - Difficulty In Walking Zoloft C Initial or Prolonged Hyperhidrosis Zantac C Required Joint Stiffness Aspirin C Intervention to Pyrexia Restoril C Prevent Permanent Stupor Hctz C Impairment/Damage Date:04/23/02ISR Number: 3905342-1Report Type:Expedited (15-DaCompany Report #APCDSS2002000366 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperidone Initial or Prolonged Dystonia Health (Risperidone0 PS ORAL ORAL Required Fall Professional Haloperidol Intervention to Medication Error (Haloperidol) SS MAXIMUM DOSE Prevent Permanent Mental Disorder WAS 16 MG/DAY 6 YR Impairment/Damage Tardive Dyskinesia Date:04/23/02ISR Number: 3905883-7Report Type:Expedited (15-DaCompany Report #HQ1853516APR2002 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Ativan (Lorazepam, Initial or Prolonged Electrocardiogram Qt Professional Expidet Tablet) PS ORAL 15 MG Prolonged Other OVERDOSE Hallucination AMOUNT, ORAL 1 DAY Intentional Overdose Lexotanil (Bromazepam) SS ORAL 55.5 MG OVERDOSE AMOUNT, ORAL 1 DAY Risperdal (Risperidone) SS ORAL 220MG OVERDOSE AMOUNT, ORAL 1 DAY Tardyferon (Ferrous Sulfate) C 22-Feb-2006 08:20 AM Page: 1265 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/02ISR Number: 3906244-7Report Type:Expedited (15-DaCompany Report #APCDSS2002000366 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Haloperidol Initial or Prolonged Difficulty In Walking Health (Haloperidol) PS MAXIMUM DOSE Required Dyskinesia Professional WAS 16 MG/DAY 6 YR Intervention to Dystonia Risperidone Prevent Permanent Fall (Unspecified) Impairment/Damage Mental Disorder (Risperidone) SS ORAL ORAL Opisthotonus Treatment Noncompliance Date:04/24/02ISR Number: 3905727-3Report Type:Expedited (15-DaCompany Report #NSADSS2002013458 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Risperdal PS ORAL Initial or Prolonged Disorientation Risperdal C ORAL Other Subdural Haematoma Biperiden Hydrochloride C UNKNOWN Haloperidol C ORAL Pipamperone Hydrochloride C UNKNOWN Properciazine C UNKNOWN Timiperone C UNKNOWN Nemonapride C UNKNOWN Date:04/24/02ISR Number: 3905728-5Report Type:Expedited (15-DaCompany Report #NSADSS2002013457 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Risperdal PS ORAL Date:04/24/02ISR Number: 3906773-6Report Type:Expedited (15-DaCompany Report #EMADSS2002000092 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Costovertebral Angle Foreign Risperdal Tenderness Health (Solution)(Risperido Dysphagia Professional ne) PS ORAL 5 ML, 2 IN 1 Eructation DAY(S), ORAL 3 DAY Extrapyramidal Disorder Plavix (Clopidogrel Hyperhidrosis Sulfate) C Pharyngolaryngeal Pain Selozok (Metoprolol Salivary Hypersecretion Succinate) C Venlafaxine (Venlafaxine) C Lorazepam (Lorazepam) C Trazolan (Trazodone Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1266 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/02ISR Number: 3905967-3Report Type:Expedited (15-DaCompany Report #NSADSS2002012912 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:04/25/02ISR Number: 3905968-5Report Type:Expedited (15-DaCompany Report #NSADSS2002012920 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:04/25/02ISR Number: 3905969-7Report Type:Expedited (15-DaCompany Report #NSADSS2002012916 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:04/26/02ISR Number: 3906848-1Report Type:Expedited (15-DaCompany Report #NSADSS2002009808 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cardiac Failure Risperdal PS ORAL Congestive Tamoxifen SS Cardiomyopathy Date:04/26/02ISR Number: 3906857-2Report Type:Expedited (15-DaCompany Report #NSADSS2002012923 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Risperdal PS ORAL Initial or Prolonged Increased Zyprexa SS ORAL 26 DAY Anaemia Akineton C UNKNOWN Aspartate Halcion C UNKNOWN Aminotransferase Depas C UNKNOWN Increased Lendormin C UNKNOWN Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Date:04/26/02ISR Number: 3906906-1Report Type:Expedited (15-DaCompany Report #EMADSS2002002648 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Skull Fracture Risperdal PS UNKNOWN Sodium Valproate C UNKNOWN Ssri C UNKNOWN Date:04/26/02ISR Number: 3906907-3Report Type:Expedited (15-DaCompany Report #EMADSS2002002604 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Risperdal PS UNKNOWN Pituitary Tumour Benign 22-Feb-2006 08:20 AM Page: 1267 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/02ISR Number: 3908112-3Report Type:Expedited (15-DaCompany Report #NSADSS2002013457 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:04/26/02ISR Number: 3908117-2Report Type:Expedited (15-DaCompany Report #APCDSS2002000328 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Foreign Risperidone (Tablet) Initial or Prolonged Cerebral Thrombosis Health (Risperidone) PS ORAL MG, DAILY, Convulsion Professional ORAL Depressed Level Of Perindopril Erbumine Consciousness (Perindopril Diarrhoea Erbumine) C Dyskinesia Terbinafine Enteritis Hydrochloride Hemiplegia (Terbinafine Hyperreflexia Hydrochloride) C Hypochloraemia Hyponatraemia Lung Neoplasm Malignant Mental Disorder Pneumonia Respiratory Tract Infection Date:04/26/02ISR Number: 3908751-XReport Type:Expedited (15-DaCompany Report #NSADSS2002012920 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, ORAL Date:04/26/02ISR Number: 3908752-1Report Type:Expedited (15-DaCompany Report #NSADSS2002012916 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:04/26/02ISR Number: 3908754-5Report Type:Expedited (15-DaCompany Report #NSADSS2002012912 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (4 Mg Professional Tablet) (Risperidone) PS ORAL 4 MG, 1 IN 1 DAY (S), ORAL 22-Feb-2006 08:20 AM Page: 1268 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/02ISR Number: 3908832-0Report Type:Expedited (15-DaCompany Report #NSADSS2002013458 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Risperdal Initial or Prolonged Difficulty In Walking Literature (Unspecified) Required Disorientation Health (Risperidone) PS ORAL 6 MG, ORAL; 8 Intervention to Irritability Professional MG, DAILY, Prevent Permanent Subdural Haematoma ORAL Impairment/Damage Biperiden Hydrochloride (Biperiden Hydrochloride) C Haloperidol (Haloperidol) C Pipamperone Hydrochloride (Pipamperone) C Properciazine C Timiperone (Timiperone) C Nemonapride (Nemonapride) C Date:04/29/02ISR Number: 3907561-7Report Type:Expedited (15-DaCompany Report #EMADSS2002002707 Age:2 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeding Disorder Neonatal Risperdal PS OTHER Initial or Prolonged Maternal Drugs Affecting Foetus Date:04/29/02ISR Number: 3907766-5Report Type:Expedited (15-DaCompany Report #NSADSS2002013846 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:04/29/02ISR Number: 3909314-2Report Type:Expedited (15-DaCompany Report #FLUV00302000796 Age:24 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased Clonic Convulsion Coma Condition Aggravated Confusional State Diarrhoea Drug Ineffective Excoriation Hallucination, Auditory Hyperreflexia Neuroleptic Malignant Syndrome Neurotoxicity Obsessive-Compulsive Disorder Psychotic Disorder 22-Feb-2006 08:20 AM Page: 1269 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Serotonin Syndrome Trichotillomania Report Source Product Role Manufacturer Route Dose Duration Literature Fluvoxamine (Fluvoxamine Maleate) PS 50MG DAILY UNK, 100MG BID UNK 3 DAY Risperidone (Risperidone) SS 1MG BID UNK, DAILY; 3MG BID UNK Date:04/29/02ISR Number: 3909531-1Report Type:Expedited (15-DaCompany Report #NSADSS2002009808 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Risperdal (0.5 Mg Congestive Professional Tablet) Cardiomyopathy (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY (S), ORAL Tamoxifen (Tamoxifen) SS Date:04/29/02ISR Number: 3909688-2Report Type:Expedited (15-DaCompany Report #EMADSS2002002604 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Foreign Risperdal Pituitary Tumour Benign Health (Unspecified) Professional (Risperidone) PS 1 MG, Date:04/29/02ISR Number: 3910008-8Report Type:Expedited (15-DaCompany Report #A208922 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Catatonia Literature Ziprasidone Po PS 120.00 MG Intervention to Homicidal Ideation Health TOTAL: BID Prevent Permanent Neuroleptic Malignant Professional Risperidone SS 6.00 MG Impairment/Damage Syndrome TOTAL:BID Paranoia Clonazepam SS 2.00 MG Suicidal Ideation TOTAL:BID Olanzapine C Date:04/29/02ISR Number: 3910011-8Report Type:Expedited (15-DaCompany Report #A205753 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Health Vistaril Capsules PS Intervention to Professional Ziprasidone SS Prevent Permanent Company Risperidal SS Impairment/Damage Representative Paxil SS Hydrochlorothiazide C Lescol(Fluvastatin) C Zocor(Simvastatin) C Tenormin(Atenolol) C 22-Feb-2006 08:20 AM Page: 1270 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unspecified Medications C Date:04/29/02ISR Number: 3910388-3Report Type:Expedited (15-DaCompany Report #NSADSS2002012923 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) PS ORAL 6 MG, 1 IN 1 Other Anaemia Professional DAY(S), ORAL Aspartate Zyprexa (Olanzapine) SS ORAL 5 MG, DAILY, Aminotransferase ORAL Increased Akineton(Biperiden Hepatic Function Abnormal Hydrochloride) C Halcion (Triazolam) C Depas (Etizolam) C Lendormin (Brotizolam) C Date:04/29/02ISR Number: 3910390-1Report Type:Expedited (15-DaCompany Report #EMADSS2002002648 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Foreign Risperdal Skull Fracture Health (Unspecified) Professional (Risperidone) PS 1.5 MG, DAILY Company Sodium Valproate Representative (Valproate Sodium) C Ssri (Ssri) C Date:04/30/02ISR Number: 3910532-8Report Type:Expedited (15-DaCompany Report #NSADSS2002013846 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:04/30/02ISR Number: 3910797-2Report Type:Expedited (15-DaCompany Report #EMADSS2002002707 Age:2 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeding Disorder Neonatal Foreign Risperdal Initial or Prolonged Maternal Drugs Affecting Health (Unspecified) Foetus Professional (Risperidone) PS MEDICATION TAKEN BY MOTHER DURING PREGNANCY Date:04/30/02ISR Number: 3910798-4Report Type:Expedited (15-DaCompany Report #APCDSS2002000366 Age:27 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:20 AM Page: 1271 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Foreign Risperidone Fall Health (Risperidone) PS MAXIMUM DOSE Tardive Dyskinesia Professional WAS 12 MG/DAY Treatment Noncompliance Haloperidol (Haloperidol) SS MAXIMUM DOSE WAS 16 MG/DAY 6 YR Quetiapine (Quetiapine) SS ORAL MG, DAILY, ORAL Diazepam (Diazepam) C Chlorpromazine (Chlorpromazine) C Clonazepam (Clonazepam) C Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Date:05/01/02ISR Number: 3908870-8Report Type:Expedited (15-DaCompany Report #NSADSS2002009804 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:05/01/02ISR Number: 3908882-4Report Type:Expedited (15-DaCompany Report #EMADSS2002002643 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Risperdal PS UNKNOWN 3 YR White Blood Cell Count Sodium Valproate C UNKNOWN Decreased Date:05/01/02ISR Number: 3909933-3Report Type:Direct Company Report #CTU 167078 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Risperdal 1 Mg PS ORAL 1 MG BID ORAL Depakote 250 Mg SS ORAL 250 MG TID ORAL Monpril C Furosemide C Micro-K C Zytrec C Glyburide C Glucophage C Celexa C Avandia C 22-Feb-2006 08:20 AM Page: 1272 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/02ISR Number: 3911213-7Report Type:Expedited (15-DaCompany Report #PHBS2002JP02215 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Foreign Tegretol Initial or Prolonged Maternal Drugs Affecting Health (Carbamazepine) PS TRANSPLACENTAL TRANSPLACENTA Foetus Professional L Neonatal Disorder Rohypnol(Flunitrazep Pregnancy am) SS TRANSPLACENTAL TRANSPLACENTA L Vegetamin (Chlorpromazine Hydrochloride) SS TRANSPLACENTAL TRANSPLACENTA L Risperdal (Risperidone) SS TRANSPLACENTAL TRANSPLACENTA L Akineton(Biperiden Hydrochloride) SS TRANSPLACENTAL TRANSPLACENTA L Sepazon (Cloxazolam) SS Date:05/01/02ISR Number: 3911512-9Report Type:Expedited (15-DaCompany Report #EMADSS2002000720 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Orthostatic Proteinuria Foreign Haldol Decanoas (50 Initial or Prolonged Study Mg/Ml Injection) Health (Haloperidol Professional Decanoate) PS INTRAMUSCULAR 100 MG, 1 IN 21 DAY (S), IM Risperidone (Microspheres) (Risperidone) SS INTRAMUSCULAR IM Date:05/02/02ISR Number: 3909668-7Report Type:Expedited (15-DaCompany Report #NSADSS2002014149 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Risperdal PS ORAL Initial or Prolonged Rhabdomyolysis Risperdal C Biperiden C UNKNOWN Lormetazepam C UNKNOWN Nifedipine C UNKNOWN Gemfibrozil C UNKNOWN Pravastatin C UNKNOWN Cerivastatin C UNKNOWN Date:05/02/02ISR Number: 3911775-XReport Type:Expedited (15-DaCompany Report #NSADSS2002009804 Age:63 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1273 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/02ISR Number: 3911940-1Report Type:Expedited (15-DaCompany Report #EMADSS2002002643 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Risperidone) PS 3 YR Professional Sodium Valproate (Valproate Sodium) C Date:05/03/02ISR Number: 3910270-1Report Type:Expedited (15-DaCompany Report #EMADSS2002002757 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Risperdal PS ORAL Condition Aggravated Risperdal C ORAL Gamma-Glutamyltransferase Risperdal C ORAL 2 MON Increased Date:05/03/02ISR Number: 3910274-9Report Type:Expedited (15-DaCompany Report #NSADSS2002014533 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Ph Decreased Risperidone PS ORAL Initial or Prolonged Confusional State Divalproex SS ORAL Other Depressed Level Of Bupropion SS UNKNOWN Consciousness Drug Level Increased Haemodialysis Intentional Overdose Respiratory Depression Restlessness Date:05/03/02ISR Number: 3910275-0Report Type:Expedited (15-DaCompany Report #NSADSS2002014674 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:05/03/02ISR Number: 3910282-8Report Type:Expedited (15-DaCompany Report #NSADSS2002014673 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:05/03/02ISR Number: 3911797-9Report Type:Expedited (15-DaCompany Report #NSADSS2002014149 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Risperdal Initial or Prolonged Hepatitis Literature (Unspecified) Paraplegia Health (Risperidone) PS ORAL MG, DAILY, Paresis Professional ORAL SEE IMAGE Biperiden (Biperiden) C Lormetazepam (Lormetazepam) C 22-Feb-2006 08:20 AM Page: 1274 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nifedipine (Nifedipine) C Gemfibrozil (Gemfibrozil) C Pravastatin (Pravastatin) C Cerivastatin (Cerivastatin) C Date:05/06/02ISR Number: 3911113-2Report Type:Expedited (15-DaCompany Report #APCDSS2002000353 Age:0 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Risperidone PS INTRA-UTERINE 129 DAY Cerebral Haemorrhage Carbamazepine C INTRA-UTERINE 129 DAY Neonatal Biperiden C INTRA-UTERINE 129 DAY Drug Withdrawal Cloxazolam C INTRA-UTERINE 129 DAY Convulsions Flunitrazepam C INTRA-UTERINE 129 DAY Drug Withdrawal Syndrome Vegetamin A C INTRA-UTERINE 51 DAY Neonatal Vegetamin B C INTRA-UTERINE 78 DAY Dysphagia Foetal Distress Syndrome Forceps Delivery Maternal Drugs Affecting Foetus Neonatal Disorder Perinatal Brain Damage Subdural Haematoma Subdural Haemorrhage Neonatal Tachypnoea Vomiting Neonatal Date:05/06/02ISR Number: 3911128-4Report Type:Expedited (15-DaCompany Report #NSADSS2002008708 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Risperdal PS ORAL Sepsis Date:05/06/02ISR Number: 3911143-0Report Type:Expedited (15-DaCompany Report #EMADSS2002001797 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Risperdal PS ORAL 21 DAY Life-Threatening Cardio-Respiratory Arrest Depamide SS UNKNOWN 26 DAY Mania Serevent SS UNKNOWN Mydriasis Ventoline SS UNKNOWN Shock Zyrtec SS UNKNOWN 18 DAY Vomiting Xanax C UNKNOWN Date:05/06/02ISR Number: 3911144-2Report Type:Expedited (15-DaCompany Report #EMADSS2002002815 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Exophthalmos Risperdal PS UNKNOWN Initial or Prolonged Gait Disturbance Chlorpromazine SS UNKNOWN 22-Feb-2006 08:20 AM Page: 1275 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/02ISR Number: 3911212-5Report Type:Expedited (15-DaCompany Report #NSADSS2002014429 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:05/06/02ISR Number: 3911360-XReport Type:Expedited (15-DaCompany Report #NSADSS2002014922 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:05/06/02ISR Number: 3912212-1Report Type:Expedited (15-DaCompany Report #02-04-0392 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Literature Fluvoxamine Maleate Initial or Prolonged Diarrhoea Health Tablets - Ipi PS ORAL 50MG HS ORAL Drug Effect Decreased Professional Risperidone Unknown SS 1-3MG BID Excoriation UNKNOWN 14 DAY Hyperhidrosis Neuroleptic Malignant Syndrome Obsessive-Compulsive Disorder Stereotypy Trichotillomania Date:05/06/02ISR Number: 3912303-5Report Type:Expedited (15-DaCompany Report #NSADSS2002014673 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:05/06/02ISR Number: 3912306-0Report Type:Expedited (15-DaCompany Report #NSADSS2002014674 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:05/06/02ISR Number: 3912309-6Report Type:Expedited (15-DaCompany Report #NSADSS2002014533 Age:38 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Ph Decreased Initial or Prolonged Confusional State Required Depressed Level Of Intervention to Consciousness Prevent Permanent Drug Level Above Impairment/Damage Therapeutic Haemodialysis Overdose Respiratory Depression 22-Feb-2006 08:20 AM Page: 1276 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Restlessness Report Source Product Role Manufacturer Route Dose Duration Literature Risperidone Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Divalproex (Valproate Semisodium) SS ORAL 180 TABLE, TOTAL, ORAL Bupropion (Amfebutamone) SS Date:05/06/02ISR Number: 3912591-5Report Type:Expedited (15-DaCompany Report #EMADSS2002002757 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Risperdal (Tablet) Other Increased Health (Risperidone) PS ORAL 1) 0.5 MG, 1 Anxiety Professional IN 1 DAY(S), Aspartate ORAL; 2) 1.5 Aminotransferase MG, 1 IN 1 Increased DAY(S), ORAL; Cardiac Disorder Gamma-Glutamyltransferase Increased Date:05/07/02ISR Number: 3911696-2Report Type:Expedited (15-DaCompany Report #NSADSS2002014844 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Risperdal PS ORAL Serzone C UNKNOWN Loxapine C UNKNOWN Date:05/07/02ISR Number: 3911857-2Report Type:Expedited (15-DaCompany Report #NSADSS2001027756 Age:96 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Risperdal PS ORAL Cardiac Failure Coumadin C UNKNOWN Congestive Lanoxin C UNKNOWN Dementia Micturition Urgency Tardive Dyskinesia Date:05/07/02ISR Number: 3912927-5Report Type:Expedited (15-DaCompany Report #APCDSS2002000353 Age: Gender:Male I/FU:F Outcome PT Life-Threatening Abdominal Distension Apgar Score Low Clonic Convulsion Complications Of Maternal Exposure To Therapeutic Drugs Convulsion Neonatal 22-Feb-2006 08:20 AM Page: 1277 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Csf Protein Increased Drug Withdrawal Convulsions Report Source Product Role Manufacturer Route Dose Duration Dysphagia Foreign Risperidone(Risperid Foetal Distress Syndrome Health one) PS MG, DAILY, Forceps Delivery Professional UTERINE Maternal Drugs Affecting Carbamazepine Foetus (Carbamazepine) C Neonatal Disorder Biperiden(Biperiden) C Perinatal Brain Damage Cloxazolam(Cloxazola Psychotic Disorder m) C Subdural Haemorrhage Flunitrazepam(Flunit Neonatal razepam) C Tachypnoea Vegetamin Vomiting Neonatal A(Vegetamin A) C Vegetemin B(Vegetamin B(R)) C Date:05/07/02ISR Number: 3912929-9Report Type:Expedited (15-DaCompany Report #APCDSS2002000428 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Apgar Score Low Foreign Risperdal(Risperidon Chondrodystrophy Health e) PS MG, DAILY, Complications Of Maternal Professional UTERINE Exposure To Therapeutic Carbamazapine(Carbam Drugs azepine) C Ear Malformation Trihexyphenidyl Maternal Drugs Affecting Hydrochloride(Trihex Foetus yphenidyl Pregnancy Hydrochloride) C Vacuum Extractor Delivery Date:05/07/02ISR Number: 3912931-7Report Type:Expedited (15-DaCompany Report #EMADSS2002001797 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Foreign Risperdal(1 Mg Life-Threatening Cardio-Respiratory Arrest Health Tablet)(Risperidone) PS ORAL 2 MG, DAILY, Mydriasis Professional ORAL Shock Depamide Vomiting (Valpromide) SS 1800 MG, DAILY Serevent(Salmeterol Xinafoate) SS Ventoline(Salbutamol ) SS Zyrtec(Cetirizine Hydrochloride) SS 10 MG, DAILY Xanax(Alprazolam) C Date:05/07/02ISR Number: 3913068-3Report Type:Expedited (15-DaCompany Report #EMADSS2002002815 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Exophthalmos Foreign Risperdal Initial or Prolonged Gait Disturbance Health (Risperidone) PS 1 MG, 2 IN 1 Professional DAY(S) 22-Feb-2006 08:20 AM Page: 1278 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chlorpromazine (Chlorpromazine) SS Date:05/07/02ISR Number: 3913241-4Report Type:Expedited (15-DaCompany Report #001-0073-M0200194 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Dilantin (Phenytoin Akathisia Professional Sodium) PS ORAL 400 MG (200 Cognitive Disorder MG, BID), PER Deep Vein Thrombosis ORAL Delusion (Gabapentin) SS Depression (Fluphenazine Drug Ineffective Deconoate) SS INTRAMUSCULAR 17.75 MG Drug Interaction (EVERY 7 Drug Level Decreased DAYS), Oral Intake Reduced INTRAMUSCULAR Protein Total Increased (Fluphenazine Tardive Dyskinesia Hydrochloride) SS 35 MG (TID & Urine Calcium Increased HS) Warfarin Sodium) SS (Fluoxetine Hydrochloride) SS (Risperidone) SS 8 MG (4 MG, BID), Date:05/07/02ISR Number: 3913491-7Report Type:Expedited (15-DaCompany Report #EMADSS2002002836 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Haldol Initial or Prolonged Myocardial Infarction Study ((Unspecified)(Halop Other Health eridol) PS 1 CAPSULE +5 Professional TABLETS Risperidone (Unspecified)(Risper idone) SS 1 CAPSULE + 5 TABLETS Placebo (Unspecified)(Placeb o) SS 1 CAPSULE +5 TABLETS Date:05/07/02ISR Number: 3913767-3Report Type:Expedited (15-DaCompany Report #NSADSS2002014922 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:05/07/02ISR Number: 3913773-9Report Type:Expedited (15-DaCompany Report #NSADSS2002008708 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Health Risperdal Professional (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1279 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/02ISR Number: 3913806-XReport Type:Expedited (15-DaCompany Report #NSADSS2002014429 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:05/08/02ISR Number: 3912055-9Report Type:Expedited (15-DaCompany Report #NSADSS2002015031 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypoglycaemic Seizure Risperdal PS ORAL Date:05/08/02ISR Number: 3912056-0Report Type:Expedited (15-DaCompany Report #NSADSS2002015035 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:05/08/02ISR Number: 3912104-8Report Type:Expedited (15-DaCompany Report #NSADSS2002009626 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:05/08/02ISR Number: 3912110-3Report Type:Expedited (15-DaCompany Report #NSADSS2002007697 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Cirrhosis Risperdal PS ORAL Hepatic Failure Date:05/08/02ISR Number: 3914884-4Report Type:Expedited (15-DaCompany Report #A044-002-003605 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Aricept (Donepezil) PS ORAL 10 MG, 1 IN 1 Initial or Prolonged Drug Interaction Health D, PER ORAL Malaise Professional Digoxine (Digoxin) SS ORAL HALF A DOSE Syncope PER DAY IN ONE INTAKE, PER ORAL Risperidone (Risperidone) SS Omeprazole (Omeprazole) C Aldactazine (Aldactazine) C Kardegic (Acetylsalicylate Lysine) C 22-Feb-2006 08:20 AM Page: 1280 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/09/02ISR Number: 3912924-XReport Type:Expedited (15-DaCompany Report #NSADSS2002002607 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Risperdal PS ORAL Initial or Prolonged Cogwheel Rigidity Tegretol SS ORAL Drooling Risperdal C ORAL Infectious Mononucleosis Lamotrigine C UNKNOWN Influenza Lethargy Somnolence Tremor Date:05/09/02ISR Number: 3912936-6Report Type:Expedited (15-DaCompany Report #NSADSS2002015357 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:05/09/02ISR Number: 3912937-8Report Type:Expedited (15-DaCompany Report #EMADSS2002002888 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukocytosis Risperdal PS ORAL Thrombocytopenia Date:05/09/02ISR Number: 3914387-7Report Type:Direct Company Report #CTU 167716 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Paxil 20 Mg PS 20 MG / 1 PER Anxiety DAY Completed Suicide Risperdal 1 Mg SS 1 MG / 2 PER Condition Aggravated DAY Confusional State Drug Level Above Therapeutic Fatigue Fear Insomnia Intentional Self-Injury Pallor Personality Change Date:05/09/02ISR Number: 3915268-5Report Type:Expedited (15-DaCompany Report #NSADSS2002015031 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Health Risperdal Hypoglycaemia Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1281 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/09/02ISR Number: 3915269-7Report Type:Expedited (15-DaCompany Report #NSADSS2002009626 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:05/09/02ISR Number: 3915270-3Report Type:Expedited (15-DaCompany Report #NSADSS2002007697 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ascites Health Risperdal Hepatic Cirrhosis Professional (Unspecified) Hepatic Failure (Risperidone) PS ORAL ORAL Date:05/09/02ISR Number: 3915330-7Report Type:Expedited (15-DaCompany Report #NSADSS2002015035 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:05/09/02ISR Number: 3915426-XReport Type:Expedited (15-DaCompany Report #NSADSS2002014844 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Risperidone) PS Professional Serzone (Nefazodone Hydrochloride) C Loxapine (Loxapine) C Date:05/09/02ISR Number: 3915785-8Report Type:Expedited (15-DaCompany Report #NSADSS2001027756 Age:96 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Health Risperdal(Risperidon Other Cardiac Failure Professional e) PS ORAL 1 MG, 1 IN 1 Congestive NIGHT(S), Condition Aggravated ORAL Micturition Urgency Coumadin(Warfarin Tardive Dyskinesia Sodium) C Lanoxin(Digoxin) C Date:05/10/02ISR Number: 3913582-0Report Type:Expedited (15-DaCompany Report #EMADSS2002002873 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Neoplasm Risperdal PS ORAL Initial or Prolonged Extrapyramidal Disorder Haldol SS ORAL Other Hyperprolactinaemia Laubeel C ORAL Tremor Urinary Incontinence 22-Feb-2006 08:20 AM Page: 1282 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/02ISR Number: 3914961-8Report Type:Expedited (15-DaCompany Report #NSADSS2002015357 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:05/10/02ISR Number: 3914963-1Report Type:Expedited (15-DaCompany Report #NSADSS2002002607 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Risperdal (Tablet) Initial or Prolonged Cogwheel Rigidity Professional (Risperidone) PS ORAL SEE IMAGE Drooling Tegretol Drug Level Decreased (Carbamazepine) SS 1200 MG, 1 IN Influenza 1 DAILY, ORAL Lethargy Lamotrigine Malaise (Lamotrigine) C Pallor Somnolence Tremor Date:05/10/02ISR Number: 3915569-0Report Type:Expedited (15-DaCompany Report #EMADSS2002002888 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Foreign Risperdal (Tablet) Thrombocytopenia Health (Risperidone) PS ORAL ORAL Professional Date:05/13/02ISR Number: 3914581-5Report Type:Expedited (15-DaCompany Report #APCDSS2002000328 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Risperidone PS ORAL 502 DAY Initial or Prolonged Convulsion Perindopril Erbumine C ORAL 7 DAY Disability Depressed Level Of Perindopril Erbumine C ORAL 442 DAY Consciousness Terbinafine Diarrhoea Hydrochloride C ORAL 495 DAY Dyskinesia Gastrointestinal Infection Hyperreflexia Hypochloraemia Hyponatraemia Lung Neoplasm Malignant Mental Disorder Pneumonia Pyrexia Respiratory Tract Infection Speech Disorder 22-Feb-2006 08:20 AM Page: 1283 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/02ISR Number: 3914625-0Report Type:Expedited (15-DaCompany Report #APCDSS2002000328 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Risperidone PS ORAL 502 DAY Initial or Prolonged Convulsion Perindopril Erbumine C ORAL 7 DAY Disability Depressed Level Of Perindopril Erbumine C ORAL 442 DAY Consciousness Terbinafine Diarrhoea Hydrochloride C ORAL 495 DAY Dyskinesia Gastrointestinal Infection Hemiplegia Hyperreflexia Hypochloraemia Hyponatraemia Lung Carcinoma Cell Type Unspecified Stage 0 Mental Disorder Pneumonia Pyrexia Respiratory Tract Infection Date:05/13/02ISR Number: 3914697-3Report Type:Expedited (15-DaCompany Report #EMADSS2002001537 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Health Risperdal PS ORAL 5 MON Initial or Prolonged Pulmonary Disease Professional Eunerpan C ORAL Increased Bronchial Secretion Salivary Hypersecretion Date:05/13/02ISR Number: 3914723-1Report Type:Expedited (15-DaCompany Report #APCDSS2002000437 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Ileus Paralytic Health Risperidone PS ORAL 1 WK Professional Date:05/13/02ISR Number: 3914726-7Report Type:Expedited (15-DaCompany Report #NSADSS2002015821 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS ORAL Professional Date:05/13/02ISR Number: 3915650-6Report Type:Expedited (15-DaCompany Report #L02-USA-00837-01 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Major Depression Literature Citalopram Intervention to Priapism Health (Citalopram Prevent Permanent Somatic Delusion Professional Hydrobromide) PS ORAL 40 MG QD PO Impairment/Damage Citalopram (Citalopram Hydrobromide) SS ORAL 20 MG QD PO 22-Feb-2006 08:20 AM Page: 1284 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperidone SS ORAL 3 MG QD PO Risperidone SS ORAL 3 MG BID PO Risperidone SS ORAL 4 MG QD PO Haloperidol C Date:05/13/02ISR Number: 3915757-3Report Type:Periodic Company Report #PHEH2002US01644 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Trileptal Grand Mal Convulsion Professional (Oxcarbazepine) Company Tablet, 300 Mg PS ORAL 600 MG, BID, Representative ORAL Effexor-Slow Release (Venlafaxine Hydrochloride) 300 Mg SS ORAL 150 MG, BID, ORAL Risperdal (Risperidone) 1.5mg SS ORAL 1.5 MG, QHS, ORAL Klonopin C Date:05/13/02ISR Number: 3916227-9Report Type:Expedited (15-DaCompany Report #EMADSS2002002836 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Haldol (Unspecified) Initial or Prolonged Myocardial Infarction Study (Haloperidol) PS 1 CAPSULE + 5 Other Health TABLETS Professional Risperidone (Unspecified) (Risperidone) SS 1 CAPSULES + 5 TABLETS Placebo (Unspecified) (Placebo) SS 1 CAPSULE + 5 TABLETS Date:05/14/02ISR Number: 3915276-4Report Type:Expedited (15-DaCompany Report #EMADSS2002002648 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Skull Fracture Risperdal PS UNKNOWN Sodium Valproate C UNKNOWN Ssri C UNKNOWN Date:05/14/02ISR Number: 3915277-6Report Type:Expedited (15-DaCompany Report #NSADSS2002009180 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Congestive Cardiomyopathy Risperdal PS ORAL Sudden Cardiac Death 22-Feb-2006 08:20 AM Page: 1285 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/02ISR Number: 3915278-8Report Type:Expedited (15-DaCompany Report #NSADSS2002009182 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Risperdal PS ORAL Congestive Date:05/14/02ISR Number: 3915279-XReport Type:Expedited (15-DaCompany Report #NSADSS2002015645 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:05/14/02ISR Number: 3915348-4Report Type:Expedited (15-DaCompany Report #NSADSS2002015644 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:05/14/02ISR Number: 3915356-3Report Type:Expedited (15-DaCompany Report #NSADSS2002015652 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:05/14/02ISR Number: 3915361-7Report Type:Expedited (15-DaCompany Report #NSADSS2002015972 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Risperdal PS ORAL Xanax C ORAL Date:05/14/02ISR Number: 3916228-0Report Type:Expedited (15-DaCompany Report #EMADSS2002002873 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Risperdal (4 Mg Initial or Prolonged Fibrous Dysplasia Of Bone Health Tablet) Required Hyperprolactinaemia Professional (Risperidone) PS ORAL 4 MG, DAILY, Intervention to Tremor ORAL Prevent Permanent Urinary Incontinence Haldol (Tablet) Impairment/Damage (Haloperidol) SS ORAL 8 MG, DAILY, ORAL Laubeel (Lorazepam) C Date:05/14/02ISR Number: 3916579-XReport Type:Expedited (15-DaCompany Report #NSADSS2002015821 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1286 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/02ISR Number: 3916825-2Report Type:Expedited (15-DaCompany Report #APCDSS2002000328 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Foreign Risperidone (Tablet) Initial or Prolonged Cerebral Thrombosis Health (Risperidone) PS ORAL MG, DAILY, Disability Convulsion Professional ORAL Depressed Level Of Perindopril Erbumine Consciousness (Perindopril Diarrhoea Erbumine) C Dyskinesia Terbinafine Gastroenteritis Hydrochloride Gastrointestinal (Terbinafine Infection Hydrochloride) C Hemiplegia Hyperreflexia Hypochloraemia Hyponatraemia Intestinal Infarction Lung Neoplasm Malignant Mental Disorder Pneumonia Pulmonary Infarction Pyrexia Date:05/14/02ISR Number: 3916826-4Report Type:Expedited (15-DaCompany Report #EMADSS2002001537 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chronic Obstructive Foreign Risperdal (Tablet) Initial or Prolonged Pulmonary Disease Health (Risperidone) PS ORAL 1.5 MG, Increased Bronchial Professional DAILY, ORAL Secretion Eunerpan (Melperone Salivary Hypersecretion Hydrochloride) C Date:05/14/02ISR Number: 3916842-2Report Type:Expedited (15-DaCompany Report #APCDSS2002000437 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ileus Paralytic Foreign Risperidone (Tablet) Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL 1 WK Date:05/15/02ISR Number: 3915792-5Report Type:Expedited (15-DaCompany Report #NSADSS2001026496 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Risperdal PS ORAL Convulsion Dilantin SS ORAL Decreased Activity Xanax C ORAL Nystagmus Paraesthesia Visual Disturbance Weight Decreased 22-Feb-2006 08:20 AM Page: 1287 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/02ISR Number: 3915796-2Report Type:Expedited (15-DaCompany Report #EMADSS2002002950 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Rhabdomyolysis Risperdal PS ORAL Risperdal C ORAL Date:05/15/02ISR Number: 3915800-1Report Type:Expedited (15-DaCompany Report #EMADSS2002002928 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anaemia Risperdal PS ORAL 2 DAY Febrile Neutropenia Risperdal C ORAL 21 DAY Feeling Abnormal Temesta C ORAL 13 DAY Hyperhidrosis Temesta C ORAL 15 DAY Leukopenia Ativan C INTRAMUSCULAR 1 DAY Neurological Symptom Cisordinol C INTRAMUSCULAR 1 DAY Torticollis Ipsatol C INTRAMUSCULAR 1 DAY Ipsatol C INTRAMUSCULAR 1 DAY Zyrtec C ORAL 23 DAY Date:05/15/02ISR Number: 3916972-5Report Type:Expedited (15-DaCompany Report #JCF-20020465 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Foreign Risperdal Initial or Prolonged Overdose Literature Risperidone PS ORAL 6 MG PER DAY Health PO Professional Clopixol C Other Lepticur C Temesta C Moditen C Neurontin C Zuclopenthixol C Tropatepine C Lorazepam C Fluphenazine C Gabapentine C Midazolam C Propofol C Remifentanil C Atracurium C Date:05/15/02ISR Number: 3916998-1Report Type:Expedited (15-DaCompany Report #NSADSS2002009180 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Congestive Cardiomyopathy Health Risperdal Sudden Cardiac Death Professional (Unspecified) (Risperidone) PS ORAL 3 MG, 2 IN 1 DAILY, ORAL Date:05/15/02ISR Number: 3917372-4Report Type:Expedited (15-DaCompany Report #EMADSS2002002648 Age: Gender: I/FU:F Outcome PT Report Source Death Skull Fracture Foreign Health 22-Feb-2006 08:20 AM Page: 1288 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Product Role Manufacturer Route Dose Duration Risperdal (Unspecified) (Risperidone) PS 1.5 MG, DAILY Sodium Valproate (Valproate Sodium) C Ssri C Date:05/15/02ISR Number: 3917373-6Report Type:Expedited (15-DaCompany Report #NSADSS2002016066 Age:58 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Risperdal Initial or Prolonged Anaesthetic Complication Literature (Unspecified) Required Vascular Health (Risperidone) PS ORAL 6 MG, DAILY, Intervention to Blood Pressure Decreased Professional ORAL Prevent Permanent Clopixol Impairment/Damage (Zuclopenthixol Decanoate) C Lepticur (Tropatepine Hydrochloride) C Temesta (Lorazepam) C Neurontin (Gabapentin) C Date:05/15/02ISR Number: 3917449-3Report Type:Expedited (15-DaCompany Report #NSADSS2002015972 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, 1 IN 12 HOUR(S), ORAL Xanax (Alprazolam) C Date:05/15/02ISR Number: 3917469-9Report Type:Expedited (15-DaCompany Report #NSADSS2002015645 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS ORAL 3 MG, 2 IN 1 Professional DAY(S), ORAL Date:05/15/02ISR Number: 3917470-5Report Type:Expedited (15-DaCompany Report #NSADSS2002015644 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1289 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/02ISR Number: 3917500-0Report Type:Expedited (15-DaCompany Report #NSADSS2002009182 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Risperdal (0.5 Mg Congestive Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Date:05/15/02ISR Number: 3917602-9Report Type:Expedited (15-DaCompany Report #NSADSS2002015652 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:05/16/02ISR Number: 3916448-5Report Type:Expedited (15-DaCompany Report #APCDSS2002000437 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ileus Paralytic Health Risperidone PS ORAL 1 WK Professional Date:05/16/02ISR Number: 3916449-7Report Type:Expedited (15-DaCompany Report #EMADSS2002003050 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypothermia Risperidone PS UNKNOWN Hospitalization - Pneumonia Initial or Prolonged Date:05/16/02ISR Number: 3916450-3Report Type:Expedited (15-DaCompany Report #NSADSS2002016395 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Risperdal PS ORAL 2 YR Professional Date:05/16/02ISR Number: 3918058-2Report Type:Expedited (15-DaCompany Report #NSADSS2001027756 Age:96 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Health Risperdal Other Cardiac Failure Professional (Unspecified) Congestive (Risperidone) PS ORAL 1 MG, 1 IN 1 Dementia NIGHT(S), Micturition Urgency ORAL Pollakiuria Coumadin (Warfarin Tardive Dyskinesia Sodium) C Lanoxin (Digoxin) C 22-Feb-2006 08:20 AM Page: 1290 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/16/02ISR Number: 3918064-8Report Type:Expedited (15-DaCompany Report #NSADSS2001026496 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Risperdal (Tablet) Convulsion Professional (Risperidone) PS ORAL ORAL Difficulty In Walking Dilantin (Phenytoin Nuclear Magnetic Sodium) SS ORAL ORAL Resonance Imaging Xanax (Alprazolam) C Abnormal Nystagmus Paraesthesia Visual Disturbance Weight Decreased Date:05/16/02ISR Number: 3918357-4Report Type:Expedited (15-DaCompany Report #EMADSS2002002928 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal (Tablet) Eyelid Function Disorder Health (Risperidone) PS ORAL 2 MG, DAILY, Feeling Abnormal Professional ORAL ; 4 Hyperhidrosis MG, DAILY, Laboratory Test Abnormal ORAL Leukopenia Temesta (Lorazepam) C Nasal Disorder Ativan (Lorazepam) C Neurological Examination Cisordinol Abnormal (Clopenthixol Neutropenia Hydrochloride) C Restlessness Ipsatol (Biperiden Seasonal Allergy Hydrochloride) C Torticollis Zyrtec (Cetirizine Hydrochloride) C Date:05/16/02ISR Number: 3918359-8Report Type:Expedited (15-DaCompany Report #EMADSS2002002950 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Foreign Risperdal (2 Mg Health Tablet) Professional (Risperidone) PS ORAL 2 MG, DAILY, ORAL Date:05/17/02ISR Number: 3916879-3Report Type:Expedited (15-DaCompany Report #NSADSS2002016585 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS ORAL Professional Date:05/17/02ISR Number: 3916882-3Report Type:Expedited (15-DaCompany Report #NSADSS2001029631 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Left Ventricular Failure Health Risperdal PS ORAL 4 DAY Oedema Professional 22-Feb-2006 08:20 AM Page: 1291 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/02ISR Number: 3919128-5Report Type:Expedited (15-DaCompany Report #NSADSS2002016395 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:05/17/02ISR Number: 3919393-4Report Type:Expedited (15-DaCompany Report #APCDSS2002000437 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ileus Paralytic Foreign Risperidone (Tablet) Required Health (Risperidone) PS ORAL MG, DAILY, Intervention to Professional ORAL 1 WK Prevent Permanent Impairment/Damage Date:05/17/02ISR Number: 3919417-4Report Type:Expedited (15-DaCompany Report #EMADSS2002003050 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypothermia Foreign Risperidone(Risperid Hospitalization - Pneumonia Consumer one) PS Initial or Prolonged Health Professional Date:05/20/02ISR Number: 3918569-XReport Type:Expedited (15-DaCompany Report #EMADSS2002003050 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Feeling Cold Risperidone PS UNKNOWN Hospitalization - Pneumonia Initial or Prolonged Date:05/20/02ISR Number: 3918570-6Report Type:Expedited (15-DaCompany Report #NSADSS2002016745 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:05/20/02ISR Number: 3918571-8Report Type:Expedited (15-DaCompany Report #NSADSS2002016747 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:05/20/02ISR Number: 3919591-XReport Type:Expedited (15-DaCompany Report #NSADSS2002016585 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1292 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/20/02ISR Number: 3919635-5Report Type:Expedited (15-DaCompany Report #NSADSS2001029631 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Left Ventricular Failure Health Risperdal Oedema Professional (Unspecified) Company (Risperidone) PS ORAL 1 MG, 2 IN Representative DAILY, ORAL Date:05/21/02ISR Number: 3918786-9Report Type:Expedited (15-DaCompany Report #NSADSS2002016891 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Risperdal PS ORAL Hospitalization - Diabetic Complication Initial or Prolonged Electrolyte Imbalance Date:05/21/02ISR Number: 3918789-4Report Type:Expedited (15-DaCompany Report #NSADSS2002016638 Age:32 WK Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Risperdal PS Complications Of Maternal Exposure To Therapeutic Drugs Feeding Disorder Maternal Drugs Affecting Foetus Premature Baby Date:05/21/02ISR Number: 3918790-0Report Type:Expedited (15-DaCompany Report #NSADSS2002016872 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Failure To Thrive Risperdal PS ORAL Date:05/21/02ISR Number: 3918909-1Report Type:Expedited (15-DaCompany Report #EMADSS2002003133 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Risperdal PS ORAL 600 DAY Initial or Prolonged Arrhythmia Previscan C UNKNOWN YR Atrial Fibrillation Previscan C UNKNOWN Bacterial Infection Sotalex C UNKNOWN Blood Pressure Increased Doliprane C UNKNOWN C-Reactive Protein Increased Cardiomegaly Condition Aggravated Disorientation Platelet Count Abnormal Prothrombin Time Prolonged Purpura Systemic Inflammatory Response Syndrome Urinary Tract Infection 22-Feb-2006 08:20 AM Page: 1293 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/02ISR Number: 3919089-9Report Type:Expedited (15-DaCompany Report #APCDSS2002000353 Age:0 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Health Risperidone PS INTRA-UTERINE 129 DAY Hospitalization - Aspiration Professional Carbamazepine C INTRA-UTERINE 129 DAY Initial or Prolonged Bradycardia Biperiden C INTRA-UTERINE 129 DAY Clonic Convulsion Cloxazolam C INTRA-UTERINE 129 DAY Csf Protein Increased Flunitrazepam C INTRA-UTERINE 129 DAY Drug Withdrawal Vegetamin A C INTRA-UTERINE 51 DAY Convulsions Vegetamin B C INTRA-UTERINE 78 DAY Dysphagia Foetal Distress Syndrome Forceps Delivery Haematoma Haemorrhage Maternal Drugs Affecting Foetus Perinatal Brain Damage Tachypnoea Vomiting Date:05/22/02ISR Number: 3919529-5Report Type:Expedited (15-DaCompany Report #NSADSS2002014974 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Risperdal PS ORAL Breast Cancer Date:05/22/02ISR Number: 3921243-7Report Type:Direct Company Report #CTU 168612 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Risperdal Jannsen Tongue Disorder Pharm PS Jannsen Pharm 2MG BID Date:05/22/02ISR Number: 3921295-4Report Type:Expedited (15-DaCompany Report #NSADSS2002016745 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, ORAL Date:05/22/02ISR Number: 3921299-1Report Type:Expedited (15-DaCompany Report #NSADSS2002016747 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 1294 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/22/02ISR Number: 3921370-4Report Type:Expedited (15-DaCompany Report #NSADSS2002016872 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Failure To Thrive Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:05/22/02ISR Number: 3921448-5Report Type:Expedited (15-DaCompany Report #NSADSS2002016891 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Health Risperdal Hospitalization - Electrolyte Imbalance Professional (Unspecified) Initial or Prolonged (Risperidone) PS ORAL ORAL Date:05/22/02ISR Number: 3922234-2Report Type:Expedited (15-DaCompany Report #NSADSS2002016638 Age:31.5 WK Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Health Risperdal(Unspecifie Required Complications Of Maternal Professional d) (Risperidone) PS NEONATE'S Intervention to Exposure To Therapeutic MOTHER Prevent Permanent Drugs RECEIVED DRUG Impairment/Damage Maternal Drugs Affecting Foetus Premature Baby Date:05/22/02ISR Number: 3922340-2Report Type:Expedited (15-DaCompany Report #EMADSS2002003133 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Risperdal (1 Mg Initial or Prolonged Bacterial Infection Health Tablet) Coagulation Factor Professional (Risperidone) PS ORAL 0.5 MG, Decreased DAILY, ORAL Disorientation Previscan Inflammation (Fluindione) C Platelet Count Abnormal Sotalex (Sotalol Purpura Hydrochloride) C Urinary Tract Infection Doliprane (Paracetamol) C Date:05/22/02ISR Number: 3922637-6Report Type:Expedited (15-DaCompany Report #APCDSS2002000353 Age:0 YR Gender:Male I/FU:F Outcome PT Life-Threatening Abdominal Distension Hospitalization - Aspiration Initial or Prolonged Birth Trauma Bradycardia Cerebral Haemorrhage Neonatal Clonic Convulsion Convulsion Neonatal Dysphagia Foetal Distress Syndrome Forceps Delivery 22-Feb-2006 08:20 AM Page: 1295 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haematoma Maternal Drugs Affecting Foetus Report Source Product Role Manufacturer Route Dose Duration Neonatal Disorder Foreign Risperidone Perinatal Brain Damage Health (Unspecified) Tachypnoea Professional (Risperidone) PS TRANSPLACENTAL MG, DAILY, Vomiting Neonatal UTERINE Carbamazepine (Carbamazepine) C Biperiden (Biperiden) C Cloxazolam (Cloxazolam) C Flunitrazepam (Flunitrazepam) C Vegetamin A (Vegetamin A) C Vegetamin B (Vegetamin B(R)) C Date:05/22/02ISR Number: 3922721-7Report Type:Expedited (15-DaCompany Report #EMADSS2002003050 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypothermia Foreign Risperidone Hospitalization - Pneumonia Consumer (Unspecified) Initial or Prolonged Health (Risperidone) PS Professional Date:05/23/02ISR Number: 3920341-1Report Type:Expedited (15-DaCompany Report #EMADSS2002003175 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Risperdal PS ORAL 13 DAY Initial or Prolonged Hypertension Risperdal C ORAL 10 DAY Supraventricular Ebrantil C ORAL Tachycardia Captohexal C ORAL Lasix C UNKNOWN Doxacor C ORAL Adalat C ORAL Minlasal C ORAL Metformin C ORAL Metohexel C ORAL Date:05/23/02ISR Number: 3920342-3Report Type:Expedited (15-DaCompany Report #NSADSS2002017060 Age:24 YR Gender:Female I/FU:I Outcome PT Caesarean Section Complications Of Maternal Exposure To Therapeutic Drugs Feeding Disorder Neonatal Maternal Drugs Affecting Foetus Neonatal Disorder Oxygen Supplementation Pregnancy 22-Feb-2006 08:20 AM Page: 1296 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Premature Baby Premature Rupture Of Membranes Report Source Product Role Manufacturer Route Dose Duration Risperdal PS ORAL Celexa C ORAL 32 DAY Prolixin C UNKNOWN Prozac C ORAL Date:05/23/02ISR Number: 3920354-XReport Type:Expedited (15-DaCompany Report #NSADSS2002017078 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:05/23/02ISR Number: 3920373-3Report Type:Expedited (15-DaCompany Report #NSADSS2002017200 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperdal PS ORAL Oxygen Saturation Decreased Sleep Apnoea Syndrome Weight Increased Date:05/23/02ISR Number: 3920575-6Report Type:Expedited (15-DaCompany Report #EMADSS2002003133 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Risperdal PS ORAL 600 DAY Initial or Prolonged Bacterial Infection Previscan C UNKNOWN YR Blood Fibrinogen Previscan C UNKNOWN Increased Sotalex C UNKNOWN Cardiomegaly Doliprane C UNKNOWN Coagulation Factor Decreased Disorientation Inflammation Platelet Count Abnormal Prothrombin Time Prolonged Purpura Urinary Tract Infection Date:05/23/02ISR Number: 3920714-7Report Type:Expedited (15-DaCompany Report #EMADSS2002003195 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mouth Ulceration Risperdal PS ORAL 39 DAY Sepsis Date:05/23/02ISR Number: 3921178-XReport Type:Direct Company Report #CTU 168736 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Risperdal 2mg Janessen PS TOPICAL 2MG 1 TAB PM 22-Feb-2006 08:20 AM Page: 1297 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report TOPICAL Date:05/23/02ISR Number: 3921864-1Report Type:Direct Company Report #CTU 168805 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pain Risperidone Initial or Prolonged Priapism -(Jannsen) PS Jannsen ORAL 4MG PO BID Required Intervention to Prevent Permanent Impairment/Damage Date:05/23/02ISR Number: 3922187-7Report Type:Expedited (15-DaCompany Report #NSADSS2002014974 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Consumer Risperdal PS ORAL MG, ORAL Breast Cancer Date:05/24/02ISR Number: 3921685-XReport Type:Expedited (15-DaCompany Report #NSADSS2002017197 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL 1 YR Aricept C ORAL Date:05/24/02ISR Number: 3921696-4Report Type:Expedited (15-DaCompany Report #EMADSS2002003050 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypothermia Risperidone PS ORAL Sotalol C ORAL Aspirin C ORAL Bendrofluazide C ORAL Cinnarizine C ORAL Date:05/24/02ISR Number: 3921704-0Report Type:Expedited (15-DaCompany Report #NSADSS2002012916 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Risperdal PS ORAL Date:05/24/02ISR Number: 3921706-4Report Type:Expedited (15-DaCompany Report #NSADSS2002016592 Age:6 MON Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Maternal Drugs Affecting Risperdal PS INTRA-UTERINE Foetus Muscle Disorder 22-Feb-2006 08:20 AM Page: 1298 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/24/02ISR Number: 3921743-XReport Type:Expedited (15-DaCompany Report #APCDSS2002000437 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Health Risperidone PS ORAL 37 DAY Initial or Prolonged Vomiting Professional Magnesium Oxide C ORAL 16 DAY Other Date:05/24/02ISR Number: 3922459-6Report Type:Direct Company Report #CTU 168900 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Ventricular Tachycardia Tequin-Gatifloxacin- 400mg Bms PS Bms INTRAVENOUS DRIP 400MG Q24 HOURS IV DRIP Risperidone-Risperid ol- 3mg Janssen SS Janssen ORAL 3MG BID ORAL Tequin C Riperidol C Artane C Levoxyl C Lasix C Kcl C Reg Insulin Sliding Scale C Ns With 20 Meq/L Kcl C Date:05/24/02ISR Number: 3922919-8Report Type:Expedited (15-DaCompany Report #NSADSS2002017078 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:05/24/02ISR Number: 3922935-6Report Type:Expedited (15-DaCompany Report #NSADSS2002017060 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Health Risperdal Complications Of Maternal Professional (Risperidone) PS ORAL ORAL Exposure To Therapeutic Celexa (Citalopram Drugs Hydrobromide) C Maternal Drugs Affecting Prolixin Foetus (Fluphenazine Premature Baby Hydrochloride) C Premature Rupture Of Prozac (Fluoxetine Membranes Hydrochloride) C Date:05/24/02ISR Number: 3922939-3Report Type:Expedited (15-DaCompany Report #NSADSS2002017200 Age:50 YR Gender:Male I/FU:I Outcome PT Other Diabetes Mellitus Required Oxygen Saturation Intervention to Decreased Prevent Permanent Sleep Apnoea Syndrome Impairment/Damage Snoring 22-Feb-2006 08:20 AM Page: 1299 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Literature Risperdal Health (Risperidone) PS ORAL 6 MG, DAILY, Professional ORAL Date:05/24/02ISR Number: 3923099-5Report Type:Expedited (15-DaCompany Report #EMADSS2002003195 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mouth Ulceration Foreign Risperidal Sepsis Health (Risperidone) PS ORAL 1 MG, DAILY, Professional ORAL Date:05/24/02ISR Number: 3923247-7Report Type:Expedited (15-DaCompany Report #EMADSS2002003175 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Risperal (0.5 Mg Initial or Prolonged Disease Recurrence Health Tablet) Hypertension Professional (Risperidone) PS ORAL 0.5 MG, Supraventricular DAILY, ORAL; Tachycardia 0.75 MG, DAILY, ORAL Erbantil (Urapidil) C Capothexal (Captopril) C Lasix (Furosemide) C Doxacor (Doxazosin Mesilate) C Adalat (Nifedipine) C Minlasal (Acetylsalicylic Acid) C Metformin (Metformin) C Metohexel (Metoprolol Tartrate) C Date:05/24/02ISR Number: 3923250-7Report Type:Expedited (15-DaCompany Report #EMADSS2002003133 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Risperdal (1 Mg Initial or Prolonged Atrial Fibrillation Health Tablet) Cardiomegaly Professional (Risperidone) PS ORAL 0.5 MG, Coagulation Factor DAILY, ORAL Decreased Previscan Drug Effect Decreased (Fluindione) C Inflammation Sotalex (Sotalol Platelet Count Abnormal Hydrochloride) C Prothrombin Time Doliprane Prolonged (Paracetamol) C Purpura Urinary Tract Infection 22-Feb-2006 08:20 AM Page: 1300 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/02ISR Number: 3922596-6Report Type:Expedited (15-DaCompany Report #EMADSS2002002888 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Leukocytosis Risperdal PS ORAL Thrombocytopenia Date:05/28/02ISR Number: 3924328-4Report Type:Expedited (15-DaCompany Report #EMADSS2002003050 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypothermia Foreign Risperidone Pneumonia Consumer (Unspecified) Health (Risperidone) PS ORAL 4 MG, DAILY, Professional ORAL Aspirin (Acetylsalicylic Acid) C Sotalol (Sotalol) C Bendrofluazide (Bendroflumethiazide ) C Cinnarizine (Cinna C Date:05/28/02ISR Number: 3924441-1Report Type:Expedited (15-DaCompany Report #NSADSS2002012916 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal (Tablet) Hypertension Professional (Risperidone) PS ORAL ORAL Date:05/28/02ISR Number: 3924444-7Report Type:Expedited (15-DaCompany Report #NSADSS2002017197 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.25 MG, 2 IN 24 HOUR(S), ORAL Aricept (Donepezil Hydrochloride) C Date:05/28/02ISR Number: 3924468-XReport Type:Expedited (15-DaCompany Report #NSADSS2002016592 Age:6 MON Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Disorder Health Risperdal Professional (Unspecified) Company (Risperidone) PS EXPOSURE IN Representative UTERO 22-Feb-2006 08:20 AM Page: 1301 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/02ISR Number: 3924559-3Report Type:Expedited (15-DaCompany Report #APCDSS2002000437 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intestinal Obstruction Foreign Risperidone(Tablet) Initial or Prolonged Health (Risperidone) PS ORAL MG, DAILY, Other Professional ORAL Required Magnesium Oxide Intervention to (Magnesium Oxide) C Prevent Permanent Impairment/Damage Date:05/29/02ISR Number: 3924055-3Report Type:Expedited (15-DaCompany Report #NSADSS2002011525 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Risperdal C ORAL Zyprexa C ORAL Celexa C ORAL Vasotec C UNKNOWN Triamterene C UNKNOWN Norvasc C UNKNOWN Date:05/29/02ISR Number: 3924072-3Report Type:Expedited (15-DaCompany Report #NSADSS2002014674 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:05/29/02ISR Number: 3924096-6Report Type:Expedited (15-DaCompany Report #EMADSS2002003308 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Risperidone PS ORAL Hypercalcaemia Valproic Acid SS ORAL Frusemide SS ORAL Aspirin SS ORAL Thyroxin SS ORAL Paroxetine SS ORAL Amlodipine C ORAL Date:05/29/02ISR Number: 3925907-0Report Type:Direct Company Report #CTU 169121 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Risperdal Hospitalization - Agitation (Resperdone) PS ORAL 0.5 MG TWICE Initial or Prolonged Cough A DAY ORAL Delirium Nausea Pyrexia 22-Feb-2006 08:20 AM Page: 1302 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/02ISR Number: 3925947-1Report Type:Direct Company Report #CTU 169128 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Risperidone PS ORAL 2MG PO BID Initial or Prolonged Syndrome Tylenol C Valproate C Mvi C Capoten C Zantac C Motrin C Debrox Drops C Date:05/29/02ISR Number: 3926040-4Report Type:Expedited (15-DaCompany Report #EMADSS2002002888 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Foreign Risperdal (Tablet) Thrombocytopenia Health (Risperidone) PS ORAL ORAL Professional Date:05/30/02ISR Number: 3925020-2Report Type:Expedited (15-DaCompany Report #EMADSS2002003267 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Reminyl PS ORAL 244 DAY Initial or Prolonged Convulsion Risperdal SS UNKNOWN Creatinine Renal Modopar C UNKNOWN Clearance Decreased Kardegic C UNKNOWN Duphalac C UNKNOWN Levothyrox C UNKNOWN Temesta C UNKNOWN Doliprane C UNKNOWN Date:05/30/02ISR Number: 3925120-7Report Type:Expedited (15-DaCompany Report #NSADSS2002017944 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS ORAL Professional Date:05/30/02ISR Number: 3925284-5Report Type:Expedited (15-DaCompany Report #APCDSS2002000512 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Depression Health Risperidone PS ORAL 1 DAY Professional Flunitrazepam C ORAL Levomepromazine Maleate C ORAL Date:05/30/02ISR Number: 3926710-8Report Type:Expedited (15-DaCompany Report #EMADSS2002003308 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Foreign Risperidone Hypercalcaemia Health (Unspecified) Professional (Risperidone) PS 1MG/2MG 22-Feb-2006 08:20 AM Page: 1303 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ALTERNATE DAYS. Thyroxin (Levothyroxine Sodium) SS ORAL 75 MCG, DAILY, ORAL Valproic Acid (Valproic Acid) SS ORAL 100 MG, 2 IN 1 DAILY, ORAL Frusemide (Furosemide) SS ORAL 40 MG, DAILY, ORAL Aspirin (Acetylsalicylic Acid) SS ORAL 75 MG, DAILY, ORAL Paroxetine (Paroxetine) SS ORAL 40 MG, DAILY, ORAL Amlodipine (Amlodipine) C Date:05/30/02ISR Number: 3926820-5Report Type:Expedited (15-DaCompany Report #NSADSS2002011525 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL SEE IMAGE Zyprexa (Olanzapine) C Celexa (Citalopram Hydrobromide) C Vasotec (Enalapril Maleate) C Triamterene (Triamterene) C Norvasc (Amlodipine Besilate) C Date:05/30/02ISR Number: 3926832-1Report Type:Expedited (15-DaCompany Report #02-0842 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Loxitane (Loxapac) PS 50 MG 1X PER Initial or Prolonged Priapism Professional 1 DAY, 1 DAY Company Nozinan Representative (Levomepromazine) SS ORAL 100 DROP 1 X PER 1 DAY, PO Risperdal (Risperidone) SS ORAL 1 TABLET 1 X PER 1 DAY, ORAL 13 DAY Tercian (Cyamemazine) SS ORAL 120 DROP 1 X PER 1 DAY, ORAL Zyprexa (Olanzapine) SS ORAL 2 TABLET 1 X PER 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1304 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Imovane (Zopiclone) C Lepticur (Tropatepine Hydrochloride) C Date:05/30/02ISR Number: 3926835-7Report Type:Expedited (15-DaCompany Report #NSADSS2002014674 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:05/31/02ISR Number: 3925976-8Report Type:Expedited (15-DaCompany Report #EMADSS2002002431 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Risperdal PS ORAL 1 DAY Initial or Prolonged Electrocardiogram Qt Professional Tardyferon C ORAL 1 DAY Prolonged Lexotanil I ORAL 1 DAY Hallucination Temesta Expidet I ORAL 1 DAY Rhabdomyolysis Sinus Tachycardia Date:05/31/02ISR Number: 3925978-1Report Type:Expedited (15-DaCompany Report #NSADSS2002017709 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prothrombin Time Health Risperdal PS ORAL 0.5mg in am Initial or Prolonged Prolonged Professional and 1 mg HS Risperdal C ORAL Tylenol C Afrin C Milf Of Magnesia C Maalox C Lasix C Zyprexa C Flomax C Micro-K C Centrum C Protonix C Zebeta C Magnesium Chloride C Date:05/31/02ISR Number: 3925979-3Report Type:Expedited (15-DaCompany Report #NSADSS2002017906 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS ORAL Professional 22-Feb-2006 08:20 AM Page: 1305 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/31/02ISR Number: 3926187-2Report Type:Expedited (15-DaCompany Report #NSADSS2002017828 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Electrocardiogram Risperdal PS ORAL dose range 1 Abnormal - 5 mg over a Hypothyroidism 13 month Tic period 1 YR Weight Increased Risperdal C ORAL 1 MON Risperdal C ORAL 2 MON Depakote C ORAL 2 YR Date:05/31/02ISR Number: 3926252-XReport Type:Expedited (15-DaCompany Report #WAES 0205USA03518 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Crixivan PS Merck & Co., Inc ORAL Initial or Prolonged Neuroleptic Malignant Risperidone SS Syndrome Risperidone SS 3 DAY Ritonavir SS Date:05/31/02ISR Number: 3926273-7Report Type:Expedited (15-DaCompany Report #EMADSS2001007495 Age:26 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Risperdal PS OTHER Initial or Prolonged Complications Of Maternal Artane C OTHER Exposure To Therapeutic Valium Roche C OTHER Drugs Theralene C OTHER Hypotonia Neonatal Maternal Drugs Affecting Foetus Somnolence Neonatal Date:05/31/02ISR Number: 3927018-7Report Type:Expedited (15-DaCompany Report #NSADSS2002017944 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:05/31/02ISR Number: 3927234-4Report Type:Expedited (15-DaCompany Report #EMADSS2002003267 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal Initial or Prolonged Convulsion Health (Unspecified) Professional (Risperidone) PS Reminyl (Tablet) (Galantamine) SS ORAL 8 MG, 2 IN 1 DAY(S), ORAL Modopar (Madopar) C Kardegic (Acetylsalicylate Lysine) C Duphalac (Lactulose) C Levothyrox (Levothyroxine 22-Feb-2006 08:20 AM Page: 1306 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Temesta (Lorazepam) C Doliprane (Paracetamol) C Date:05/31/02ISR Number: 3927237-XReport Type:Expedited (15-DaCompany Report #APCDSS2002000512 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Depression Foreign Risperidone (0.5 Mg Health Tablet) Professional (Risperidone) PS ORAL MG, DAILY, ORAL Flunitrazepam (Flunitrazepam) C Levomepromazine Maleate (Levomepromazine Maleate) C Date:06/03/02ISR Number: 3926610-3Report Type:Expedited (15-DaCompany Report #NSADSS2002018258 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL 1 YR Date:06/03/02ISR Number: 3928380-1Report Type:Expedited (15-DaCompany Report #NSADSS2002017906 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Tablet) Health (Risperidone) PS ORAL ORAL Professional Date:06/03/02ISR Number: 3928557-5Report Type:Expedited (15-DaCompany Report #EMADSS2002002431 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Risperdal (1 Mg Initial or Prolonged Cardiac Enzymes Increased Health Tablet) Dehydration Professional (Risperidone) PS ORAL 220 MG, 1 IN Electrocardiogram Qt 1 DAY(S), Prolonged ORAL Electrocardiogram T Wave Lexotanil Inversion (Bromazepam) SS ORAL 56.5 MG, 1 IN Hallucination 1 DAY(S), Intentional Overdose ORAL Rhabdomyolysis Temesta Expidet Sinus Tachycardia (Lorazepam) SS ORAL 15 MG, 1 IN 1 DAY(S), ORAL Tardyferon (Ferrous Sulfate) C 22-Feb-2006 08:20 AM Page: 1307 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/02ISR Number: 3928558-7Report Type:Expedited (15-DaCompany Report #EMADSS2001007495 Age:26 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Risperdal Initial or Prolonged Hypotonia Neonatal Health (Unspecified) Maternal Drugs Affecting Professional (Risperidone) PS TAKEN BY Foetus MOTHER DURING Somnolence Neonatal PREGNANCY. Artane (Trihexyphenidyl) C Valium Roche (Diazepam) C Theralene (Alimemazine Tartrate) C Date:06/03/02ISR Number: 3928602-7Report Type:Expedited (15-DaCompany Report #NSADSS2002017709 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prothrombin Time Health Risperdal(1 Mg Initial or Prolonged Prolonged Professional Tablet) (Risperidone) PS HEMODIALYSIS 0.5MG IN AM AND 1 MG HS Tylenol(Paracetamol) C Afrin(Afrin) C Milf Of Magnesia(Magnesium Hydroxide) C Maalox(Maalox) C Lasix(Furosemide) C Zyprexa(Olanzapine) C Flomax(Tamsulosin Hydrochloride) C Micro-K(Potassium Chloride) C Centrum(Centrum) C Protonix(Pantoprazol e) C Zebeta(Bisoprolol Fumarate) C Magnesium Chloride(Magnesium Sulfate) C Date:06/03/02ISR Number: 3928605-2Report Type:Expedited (15-DaCompany Report #NSADSS2002017828 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Consumer Risperdal Abnormal (Tablet)(Risperidone Eye Movement Disorder ) PS DOSE RANGE Hypothyroidism 1-5 MG OVER A Tic 13 MONTH Weight Increased PERIOD Depakote (Valproate Semisodium) C 22-Feb-2006 08:20 AM Page: 1308 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/02ISR Number: 3928736-7Report Type:Expedited (15-DaCompany Report #HQ2474228MAY2002 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Literature Effexor (Venlafaxine Initial or Prolonged Asthenia Hydrochloride, ) PS ORAL ORAL Other Confusional State Risperidone Coordination Abnormal (Risperidone, ) SS ORAL INITIAL DOSE Dizziness UNKNOWN THEN Tremor DOSE INCREASED, ORAL Date:06/04/02ISR Number: 3927252-6Report Type:Expedited (15-DaCompany Report #EMADSS2002003319 Age:76 YR Gender:Male I/FU:U Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Necrosis Risperdal PS ORAL Initial or Prolonged Penis Disorder Fluoxetine C UNKNOWN Other Priapism Sexual Dysfunction Date:06/04/02ISR Number: 3927253-8Report Type:Expedited (15-DaCompany Report #EMADSS2002003338 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anal Sphincter Atony Risperdal PS UNKNOWN Hospitalization - Bladder Sphincter Atony Initial or Prolonged Blood Creatine Phosphokinase Increased Extrapyramidal Disorder Rhabdomyolysis Tachypnoea Date:06/04/02ISR Number: 3927254-XReport Type:Expedited (15-DaCompany Report #EMADSS2002003475 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blepharospasm Risperdal PS ORAL Date:06/04/02ISR Number: 3927313-1Report Type:Expedited (15-DaCompany Report #NSADSS2002012912 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disease Progression Risperdal PS ORAL 221 DAY Neoplasm Malignant Tegretol C ORAL 221 DAY Date:06/04/02ISR Number: 3927329-5Report Type:Expedited (15-DaCompany Report #EMADSS2002003482 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Risperdal PS ORAL Hospitalization - Akineton C UNKNOWN Initial or Prolonged Seropram C UNKNOWN Moxacef C UNKNOWN 22-Feb-2006 08:20 AM Page: 1309 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/02ISR Number: 3927346-5Report Type:Expedited (15-DaCompany Report #EMADSS2002003487 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Adenoma Benign Risperdal PS UNKNOWN Date:06/04/02ISR Number: 3927361-1Report Type:Expedited (15-DaCompany Report #NSADSS2002014974 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Risperdal PS ORAL Breast Cancer Pituitary Tumour Benign Date:06/04/02ISR Number: 3927372-6Report Type:Expedited (15-DaCompany Report #NSADSS2002018408 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:06/04/02ISR Number: 3927383-0Report Type:Expedited (15-DaCompany Report #NSADSS2002018403 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Risperdal PS ORAL 6 mg at night Risperdal C ORAL Risperdal C ORAL Azithromycin C UNKNOWN Date:06/04/02ISR Number: 3928183-8Report Type:Expedited (15-DaCompany Report #WAES 0205USA03518 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Literature Cap Crixivan Unk PS ORAL 800 MG DAILY Initial or Prolonged Extrapyramidal Disorder Other PO Neuroleptic Malignant Risperidone Unk SS SEE IMAGE 3 DAY Syndrome Ritonavir Unk SS 400 MG DAILY UNK Date:06/04/02ISR Number: 3929167-6Report Type:Expedited (15-DaCompany Report #NSADSS2002018258 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (.25mg Professional Tablet) (Risperidone) PS ORAL 0.25MG, DAILY, ORAL Date:06/04/02ISR Number: 3943964-2Report Type:Periodic Company Report #237292 Age:25 YR Gender:Female I/FU:F Outcome PT Required Abnormal Dreams Intervention to Anxiety Prevent Permanent Confusional State Impairment/Damage Crying 22-Feb-2006 08:20 AM Page: 1310 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Dissociation Fatigue Report Source Product Role Manufacturer Route Dose Duration Feeling Abnormal Consumer Lariam (Mefloquine Hallucination Health Hydrochloride) 250 Hallucination, Auditory Professional Mg PS ORAL 250 MG 1 PER Hallucination, Visual WEEK ORAL Hyperglycaemia Valium (Diazepam) SS Hyperventilation Risperdal Jamais Vu (Risperidone) SS Psychotic Disorder Zyprexa (Olanzapine) SS Suicidal Ideation Thinking Abnormal Tremor Date:06/05/02ISR Number: 3927649-4Report Type:Expedited (15-DaCompany Report #NSADSS2002014673 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal PS ORAL 71 DAY Risperdal C ORAL Prolixin C INTRAMUSCULAR 18 YR Cogentin C ORAL 4 YR Cogentin C ORAL Date:06/05/02ISR Number: 3928496-XReport Type:Direct Company Report #CTU 169580 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Geodon 20mg PS ORAL 20MG BID PO, Initial or Prolonged Tunnel Vision 40MG BID PO Vision Blurred Risperdal 1mg Visual Disturbance Janssen SS Janssen ORAL 1MG BID PO Visual Field Defect Wellbutrin C Trazodone C Lorazepam C Date:06/05/02ISR Number: 3929536-4Report Type:Expedited (15-DaCompany Report #NSADSS2002018408 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:06/05/02ISR Number: 3929538-8Report Type:Expedited (15-DaCompany Report #NSADSS2002014974 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Consumer Risperdal (Tablet) Breast Cancer (Risperidone) PS ORAL MG, ORAL Pituitary Tumour Benign 22-Feb-2006 08:20 AM Page: 1311 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/02ISR Number: 3929760-0Report Type:Expedited (15-DaCompany Report #NSADSS2002012912 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (4 Mg Professional Tablet) (Risperidone) PS ORAL 4 MG, 1 IN 1 DAY(S), ORAL Tegretol (Carbamazepine) C Date:06/05/02ISR Number: 3929870-8Report Type:Expedited (15-DaCompany Report #NSADSS2002018403 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Risperdal Professional (Unspecified) (Risperidone) PS 6 MG AT NIGHT Azithromycin (Azithromycin) C Date:06/05/02ISR Number: 3929910-6Report Type:Expedited (15-DaCompany Report #EMADSS2002003338 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bladder Disorder Foreign Risperdal Hospitalization - Blood Creatine Health (Unspecified) Initial or Prolonged Phosphokinase Increased Professional (Risperidone) PS 6 MG, DAILY, Extrapyramidal Disorder UNKNOWN Intestinal Functional Disorder Rhabdomyolysis Tachypnoea Date:06/05/02ISR Number: 3929915-5Report Type:Expedited (15-DaCompany Report #EMADSS2002003482 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperdal (Solution) Hospitalization - Health (Risperidone) PS ORAL 3 MG, DAILY, Initial or Prolonged Professional ORAL Akineton (Biperiden Hydrochloride) C Seropram (Citalopram Hydrobromide) C Moxacef (Cefadroxil) C Date:06/05/02ISR Number: 3930559-XReport Type:Expedited (15-DaCompany Report #EMADSS2002003319 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erectile Dysfunction Foreign Risperdal (Tablet) Initial or Prolonged Necrosis Health (Risperidone) PS ORAL 2 MG, DAILY, Required Penis Disorder Professional ORAL Intervention to Priapism Fluoxetine Prevent Permanent (Fluoxetine) C Impairment/Damage 22-Feb-2006 08:20 AM Page: 1312 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/02ISR Number: 3930633-8Report Type:Expedited (15-DaCompany Report #EMADSS2002003475 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blepharospasm Foreign Risperdal (1 Mg Health Tablet) Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Date:06/05/02ISR Number: 3930672-7Report Type:Expedited (15-DaCompany Report #EMADSS2002003487 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Adenoma Benign Foreign Risperdal Health (Risperidone) PS 2 MG Professional Date:06/06/02ISR Number: 3928395-3Report Type:Expedited (15-DaCompany Report #EMADSS2002003499 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hallucination, Visual Health Risperdal PS ORAL Panic Reaction Professional Ditropan SS ORAL 289 DAY Atarax C ORAL Date:06/06/02ISR Number: 3928416-8Report Type:Expedited (15-DaCompany Report #EMADSS2002003501 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Macular Degeneration Health Risperdal PS ORAL 9 MON Professional Date:06/06/02ISR Number: 3929555-8Report Type:Expedited (15-DaCompany Report #NSADSS2002014673 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL 2 MG, 1 IN 1 NIGHT(S), ORAL Prolixin (Fluphenazine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Date:06/07/02ISR Number: 3929298-0Report Type:Expedited (15-DaCompany Report #NSADSS2002018856 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abdominal Pain Risperdal PS ORAL Drug Toxicity Tegretal C ORAL Vomiting 22-Feb-2006 08:20 AM Page: 1313 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/02ISR Number: 3929441-3Report Type:Direct Company Report #CTU 169676 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Depakote PS 1000 MG BID Initial or Prolonged Lethargy Risperidone SS ORAL 1 MG PO BID Stupor Lithium SS 450 MG BID Vision Blurred Quetiapine SS 200 MG BID Hydroxyzine C Naproxen C Citalopram C Lorazepam C Date:06/07/02ISR Number: 3929628-XReport Type:Expedited (15-DaCompany Report #EMADSS2002003514 Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperdal PS ORAL Initial or Prolonged Fear Hydergin SS ORAL 6 DAY Illusion Date:06/07/02ISR Number: 3929629-1Report Type:Expedited (15-DaCompany Report #NSADSS2002018957 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oral Intake Reduced Risperdal PS ORAL 1 YR Date:06/07/02ISR Number: 3930723-XReport Type:Expedited (15-DaCompany Report #EMADSS2002003501 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Macular Degeneration Foreign Risperdl (3 Mg Health Tablet) Professional (Risperidone) PS OPHTHALMIC 3 MG, DAILY, ORAL Date:06/07/02ISR Number: 3930733-2Report Type:Expedited (15-DaCompany Report #EMADSS2002003499 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hallucination, Visual Foreign Risperdal Panic Reaction Health (Risperidone) PS ORAL ORAL Professional Ditropan (Oxybutynin) SS ORAL 5 MG, DAILY, ORAL Atarax (Hydroxyzine Hydrochloride) C Date:06/10/02ISR Number: 3929999-4Report Type:Expedited (15-DaCompany Report #WAES 0205USA03518 Age:30 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Pressure Decreased Initial or Prolonged Blood Sodium Increased Blood Urea Increased Drug Interaction Drug Level Increased 22-Feb-2006 08:20 AM Page: 1314 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Health Crixivan PS Merck & Co., Inc ORAL Professional Crixivan SS ORAL Risperidone SS Risperidone SS 1 DAY Risperidone SS 3 DAY Ritonavir SS Ciprofloxacin C Ethionamide C Myambutol C Rifabutin C Fluconazole C Itraconazole C Clotrimazole C Prednisone C Morphine Sulfate C Acyclovir C Sulfamethoxazole And Trimethoprim C Lorazepam C Didanosine C Abacavir Sulfate C Date:06/10/02ISR Number: 3930925-2Report Type:Direct Company Report #CTU 169799 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Risperidone PS Intervention to Eye Movement Disorder Prevent Permanent Impairment/Damage Date:06/10/02ISR Number: 3931432-3Report Type:Expedited (15-DaCompany Report #NSADSS2002018957 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Oral Intake Reduced Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 2 IN 24 HOUR (S), ORAL Date:06/10/02ISR Number: 3931433-5Report Type:Expedited (15-DaCompany Report #NSADSS2002018856 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Health Risperdal (0.5 Mg Drug Level Increased Professional Tablet) Vomiting (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY (S), ORAL Tegretal (Carbamazepine) C 22-Feb-2006 08:20 AM Page: 1315 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/10/02ISR Number: 3931450-5Report Type:Expedited (15-DaCompany Report #EMADSS2002003514 Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Risperdal (Tablet) Initial or Prolonged Illusion Health (Risperidone) PS ORAL 1 MG, DAILY, Professional ORAL Hydergin (Hydergin) SS ORAL 6, DAILY, ORAL Date:06/11/02ISR Number: 3930352-8Report Type:Expedited (15-DaCompany Report #NSADSS2002018952 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Risperdal PS ORAL Hospitalization - Circulatory Collapse Risperdal C ORAL Initial or Prolonged Date:06/11/02ISR Number: 3930526-6Report Type:Expedited (15-DaCompany Report #NSADSS2002019181 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:06/11/02ISR Number: 3930535-7Report Type:Expedited (15-DaCompany Report #NSADSS2002015645 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:06/11/02ISR Number: 3930584-9Report Type:Expedited (15-DaCompany Report #EMADSS2002003574 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Risperdal PS ORAL 2 MON Initial or Prolonged Glossitis Risperdal C ORAL 41 DAY Leukopenia Dipiperon C ORAL Thrombocytopenia Digimerck C ORAL Tavor C UNKNOWN Date:06/12/02ISR Number: 3931843-6Report Type:Expedited (15-DaCompany Report #APCDSS2002000564 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Complications Of Maternal Risperdal PS ORAL Exposure To Therapeutic Clonazepam C ORAL 544 DAY Drugs Clonazepam C ORAL Eclampsia Trihexyphenidyl C ORAL 107 DAY Pregnancy Trihexyphenidyl C ORAL Date:06/12/02ISR Number: 3931844-8Report Type:Expedited (15-DaCompany Report #NSADSS2002019508 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Risperdal PS ORAL 22-Feb-2006 08:20 AM Page: 1316 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/12/02ISR Number: 3931845-XReport Type:Expedited (15-DaCompany Report #APCDSS2002000568 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Sick Sinus Syndrome Risperdal PS ORAL 2 DAY Carbamazepine C ORAL Zotepine C ORAL Zotepine C ORAL Lithium Carbonate C ORAL Date:06/12/02ISR Number: 3932507-5Report Type:Direct Company Report #CTU 170043 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Risperdal Janssen PS Janssen ORAL PO 1MG BID Syndrome AND 3MG QHS Somnolence Depakote C Clonazepam C Prozac C Bactrim Ds C Date:06/12/02ISR Number: 3932661-5Report Type:Expedited (15-DaCompany Report #13470 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Depression Foreign Ditropan Tablet Other Hallucination, Visual Health (Oxybutynin Panic Reaction Professional Chloride) PS ORAL 5MG 1X/1DAY , PO Risperdal SS ORAL PO Hydroxyzine Hyd C Atarax C Date:06/12/02ISR Number: 3932975-9Report Type:Expedited (15-DaCompany Report #EMADSS2002003501 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Macular Degeneration Risperdal PS ORAL 9 MON Maculopathy Date:06/13/02ISR Number: 3933491-0Report Type:Direct Company Report #CTU 170133 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperidone PS ORAL 3MG PO QD > Phosphokinase Increased 1YR Lisinopril C Date:06/13/02ISR Number: 3934084-1Report Type:Expedited (15-DaCompany Report #APCDSS2002000568 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sick Sinus Syndrome Foreign Risperdal (Tablet) Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Carbamazepine (Carbamazepine) C 22-Feb-2006 08:20 AM Page: 1317 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zotepine (Zotepine) C Lithium Carbonate (Lithium Carbonate) C Date:06/13/02ISR Number: 3934085-3Report Type:Expedited (15-DaCompany Report #APCDSS2002000564 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Risperdal Exposure To Therapeutic Health (Unspecified) Drugs Professional (Risperidone) PS ORAL MG, DAILY, Eclampsia ORAL Pregnancy Clonazepam (Clonazepam) C Trihexyphenidyl (Trihexyphnidyl) C Date:06/13/02ISR Number: 3934323-7Report Type:Expedited (15-DaCompany Report #NSADSS2002019508 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:06/13/02ISR Number: 3934435-8Report Type:Expedited (15-DaCompany Report #HQ2643407JUN2002 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bronchopneumonia Health Efexor Er Hospitalization - Cholestasis Professional (Venlafaxine Initial or Prolonged Drug Interaction Hydrochloride, Hypertension Capsule, Extended Neuroleptic Malignant Release) PS ORAL 150 MG 1X PER Syndrome 1 DAY ORAL WK Tardive Dyskinesia Melleril Retard (Thioridazine Hydrochloride) SS ORAL 30 MG 2 X PER 1 DAY ORAL (YEARS) YR Risperdal (Risperidone) SS ORAL 1 MG 1X PER 1 DAY ORAL (MONTHS) Xanax (Alprazolam) C Calcimagon (Calcium Carbonate/Colecalcif erol) C Date:06/14/02ISR Number: 3932804-3Report Type:Expedited (15-DaCompany Report #EMADSS2002003341 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dystonia Risperdal PS ORAL Extrapyramidal Disorder Eunerpan C ORAL 14 DAY Tavor C ORAL 14 DAY 22-Feb-2006 08:20 AM Page: 1318 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/02ISR Number: 3932815-8Report Type:Expedited (15-DaCompany Report #EMADSS2002003499 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Risperdal PS ORAL Bite Ditropan SS ORAL 289 DAY Depression Atarax C ORAL Hallucination, Visual Initial Insomnia Panic Reaction Sleep Terror Suicidal Ideation Date:06/14/02ISR Number: 3932816-XReport Type:Expedited (15-DaCompany Report #NSADSS2002019630 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pharyngitis Risperdal PS ORAL Platelet Count Abnormal Zoloft C ORAL Remeron C ORAL Date:06/14/02ISR Number: 3932817-1Report Type:Expedited (15-DaCompany Report #NSADSS2002009182 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Risperdal PS ORAL Oedema Date:06/14/02ISR Number: 3932929-2Report Type:Expedited (15-DaCompany Report #NSADSS2002019408 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Risperdal PS ORAL Decreased Date:06/14/02ISR Number: 3932930-9Report Type:Expedited (15-DaCompany Report #NSADSS2002019600 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Risperdal PS ORAL Decreased Date:06/17/02ISR Number: 3933457-0Report Type:Expedited (15-DaCompany Report #NSADSS2002016388 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Risperdal PS ORAL Hospitalization - Syndrome Initial or Prolonged Date:06/17/02ISR Number: 3935297-5Report Type:Expedited (15-DaCompany Report #WAES 0205USA03518 Age:30 YR Gender:Female I/FU:F Outcome PT Hospitalization - Cerebral Atrophy Initial or Prolonged Drug Interaction 22-Feb-2006 08:20 AM Page: 1319 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Literature Cap Crixivan PS ORAL 400MG/DAILY/P Health O, 800 MG/ Professional DAILY/ PO Risperidone SS 1 MG DAILY , 1.5 MG DAILY, 0.5 MG DAILY 3 DAY Ritonavir SS 400 MG/DAILY Myambutol C Abacavir Sulfate C Acyclovir C Ciprofloxacin C Clotrimazole C Didanosine C Ethionamide C Fluconazole C Itraconazole C Lorazepam C Morphine Sulfate C Prednisone C Rifabutin C Sulfamethoxazole (+) Trimethopri C Date:06/17/02ISR Number: 3935374-9Report Type:Expedited (15-DaCompany Report #NSADSS2002019942 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:06/17/02ISR Number: 3935375-0Report Type:Expedited (15-DaCompany Report #EMADSS2002003705 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neuropathy Peripheral Risperidone PS UNKNOWN Date:06/17/02ISR Number: 3935376-2Report Type:Expedited (15-DaCompany Report #EMADSS2002003718 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Agranulocytosis Risperdal PS UNKNOWN Date:06/17/02ISR Number: 3935377-4Report Type:Expedited (15-DaCompany Report #NSADSS2002007061 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Cancer Risperdal PS UNKNOWN Date:06/17/02ISR Number: 3935445-7Report Type:Expedited (15-DaCompany Report #NSADSS2002009182 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Death Dyspnoea Consumer Oedema Health 22-Feb-2006 08:20 AM Page: 1320 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal (0.5 Mg Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Date:06/17/02ISR Number: 3935446-9Report Type:Expedited (15-DaCompany Report #NSADSS2002019408 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Risperdal (Tablet) Decreased Professional (Risperidone) PS ORAL ORAL Date:06/17/02ISR Number: 3935448-2Report Type:Expedited (15-DaCompany Report #NSADSS2002019600 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Risperdal (Tablet) Decreased Professional (Risperidone) PS ORAL ORAL Date:06/17/02ISR Number: 3935577-3Report Type:Expedited (15-DaCompany Report #NSADSS2002019630 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pharyngitis Health Risperdal (1 Mg Platelet Count Decreased Professional Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Zoloft (Sertraline Hydrochloride) C Remeron (Mirtazapine) C Date:06/17/02ISR Number: 3935593-1Report Type:Expedited (15-DaCompany Report #NSADSS2002019628 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Haldol (Unspecified) Initial or Prolonged Syndrome Professional (Haloperidol) PS Risperdal (Unspecified) (Risperidone) SS ORAL ORAL Zyprexa (Olanzapine) SS ORAL ORAL Date:06/17/02ISR Number: 3935909-6Report Type:Expedited (15-DaCompany Report #EMADSS2002003341 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dystonia Foreign Risperdal (Tablet) Other Infection Health (Risperidone) PS ORAL 4 MG, DIALY, Professional ORAL Eunerpan (Melperone Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1321 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tavor (Lorazepam) C Date:06/17/02ISR Number: 3935913-8Report Type:Expedited (15-DaCompany Report #EMADSS2002003499 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abnormal Behaviour Foreign Risperdal Bladder Disorder Health (Unspecified) Depression Professional (Risperidone) PS ORAL ORAL Hallucination, Visual Ditropan Initial Insomnia (Oxybutynin) SS ORAL 5 MG, DAILY, Panic Attack ORAL Panic Reaction Atarax (Hydroxyzine Sleep Terror Hydrochloride) C Suicidal Ideation Date:06/17/02ISR Number: 3936062-5Report Type:Expedited (15-DaCompany Report #APCDSS2001001538 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Haldol (Unspecified) Initial or Prolonged Condition Aggravated Health (Haloperidol) PS ORAL MG, DAILY, Other Hallucination, Visual Professional ORAL Hepatocellular Damage Risperidone (Tablet) Impulse-Control Disorder (Risperidone) SS ORAL MG, DAILY, Insomnia ORAL Irritability Mianserin Neuroleptic Malignant Hydrochloride Syndrome (Mianserin Pyrexia Hydrochloride) SS ORAL ORAL Lorazepam (Lorazepam) SS Amantadine (Amantadine) SS ORAL ORAL Carbamazepine (Carbamazepine) SS DAILY Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS ORAL DAILY, ORAL Magnesium Oxide (Magnesium Oxide) C Sennosides (Sennosides) C Levomepromazine (Levomepromazine) C Flunitrazepam (Flunitrazepam) C Date:06/18/02ISR Number: 3934381-XReport Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11870821 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Tequin Inj PS Bristol-Myers Squibb Prolonged Professional Company INTRAVENOUS dose reduced Ventricular Tachycardia to 200 mg on May 16, 2002 Tequin Inj SS Bristol-Myers Squibb 22-Feb-2006 08:20 AM Page: 1322 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company INTRAVENOUS dose reduced to 200 mg on May 16, 2002 Risperdal SS Artane C Levoxyl C Date:06/18/02ISR Number: 3935945-XReport Type:Expedited (15-DaCompany Report #NSADSS2002019942 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:06/18/02ISR Number: 3936049-2Report Type:Expedited (15-DaCompany Report #NSADSS2002016388 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Risperdal(Risperidon Hospitalization - Syndrome Professional e) PS ORAL ORAL Initial or Prolonged Company Representative Date:06/18/02ISR Number: 3936347-2Report Type:Expedited (15-DaCompany Report #EMADSS2002003718 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS 3 MG, DAILY Date:06/18/02ISR Number: 3936349-6Report Type:Expedited (15-DaCompany Report #EMADSS2002003705 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuropathy Peripheral Foreign Risperidone Health (Unspecified) Professional (Risperidone) PS Date:06/19/02ISR Number: 3934725-9Report Type:Expedited (15-DaCompany Report #NSADSS2002020116 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Health Risperdal PS ORAL Thrombocytopenia Professional Date:06/19/02ISR Number: 3934833-2Report Type:Expedited (15-DaCompany Report #EMADSS2002003705 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neuropathy Peripheral Health Risperidone PS UNKNOWN Professional Citalopram C UNKNOWN Valproate Sodium C UNKNOWN 22-Feb-2006 08:20 AM Page: 1323 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/19/02ISR Number: 3935740-1Report Type:Direct Company Report #CTU 170455 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Benztropine PS 1MG TID Initial or Prolonged Delirium Risperidone SS 1 MG BID Required Intervention to Prevent Permanent Impairment/Damage Date:06/19/02ISR Number: 3936386-1Report Type:Expedited (15-DaCompany Report #NSADSS2002007061 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Foreign Risperdal Health (Risperidone) PS Professional Date:06/19/02ISR Number: 3938190-7Report Type:Expedited (15-DaCompany Report #EMADSS2002003341 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Extrapyramidal Disorder Risperdal PS ORAL Infection Eunerpan C ORAL 14 DAY Tavor C ORAL 14 DAY Date:06/20/02ISR Number: 3936775-5Report Type:Direct Company Report #CTU 170635 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Zoloft 10mg? Pfizer PS Pfizer BUCCAL 2-3 X DAY Life-Threatening Feeling Abnormal BUCCAL Hospitalization - Risperdol 5mg? SS BUCCAL 2 X DAY Initial or Prolonged BUCCAL Required Intervention to Prevent Permanent Impairment/Damage Date:06/21/02ISR Number: 3936453-2Report Type:Expedited (15-DaCompany Report #EMADSS2002003717 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Risperdal PS ORAL 41 DAY Hospitalization - Drowning Lepticur SS UNKNOWN 40 DAY Initial or Prolonged Seresta SS ORAL 41 DAY Date:06/21/02ISR Number: 3936535-5Report Type:Expedited (15-DaCompany Report #NSADSS2002020396 Age:103 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Failure Health Risperdal PS ORAL Professional 22-Feb-2006 08:20 AM Page: 1324 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/02ISR Number: 3936547-1Report Type:Expedited (15-DaCompany Report #EMADSS2002003777 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Prolactin Increased Risperdal PS ORAL 8 MON Life-Threatening Breast Cancer Female Trazodone C ORAL One-Alpha C UNKNOWN Date:06/21/02ISR Number: 3936574-4Report Type:Expedited (15-DaCompany Report #EMADSS2002003050 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypothermia Risperidone PS ORAL Life-Threatening Pneumonia Cinnarizine SS ORAL 3 DAY Hospitalization - Sotalol C ORAL Initial or Prolonged Aspirin C ORAL Bendrofluazide C ORAL Date:06/21/02ISR Number: 3937223-1Report Type:Direct Company Report #CTU 170672 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diabetic Ketoacidosis Risperidole PS 6MG QHS Mental Status Changes Date:06/21/02ISR Number: 3937438-2Report Type:Expedited (15-DaCompany Report #NSADSS2002019890 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Health Risperdal (Tablet) Pituitary Tumour Professional (Risperidone) PS ORAL 6 MG, 1 IN 24 HOURS ORAL Date:06/21/02ISR Number: 3937552-1Report Type:Expedited (15-DaCompany Report #EMADSS2002003341 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dystonia Foreign Risperdal (Tablet) Other Extrapyramidal Disorder Health (Risperidone) PS ORAL 4 MG, DAILY, Professional ORAL Eunerpan (Melperone Hydrochloride) C Tavor (Lorazepam) C Date:06/21/02ISR Number: 3937569-7Report Type:Expedited (15-DaCompany Report #NSADSS2002008899 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS TOOK APPROX 60 TAB AT ONCE 22-Feb-2006 08:20 AM Page: 1325 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/02ISR Number: 3937572-7Report Type:Expedited (15-DaCompany Report #NSADSS2002020116 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Epistaxis Consumer Risperdal (Tablet) Thrombocytopenia Health (Risperidone) PS ORAL ORAL Professional Date:06/21/02ISR Number: 3937605-8Report Type:Expedited (15-DaCompany Report #EMADSS2002003705 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuropathy Peripheral Foreign Risperidone Health (Unspecified) Professional (Risperidone) PS UNK Citalopram (Citalopram) C Valproate Sodium (Valproate Sodium) C Date:06/21/02ISR Number: 3938661-3Report Type:Expedited (15-DaCompany Report #NSADSS2002020227 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS ORAL Professional Date:06/21/02ISR Number: 3938662-5Report Type:Expedited (15-DaCompany Report #NSADSS2002020399 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:06/21/02ISR Number: 3938663-7Report Type:Expedited (15-DaCompany Report #NSADSS2002020390 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS ORAL Professional Date:06/21/02ISR Number: 3938664-9Report Type:Expedited (15-DaCompany Report #NSADSS2002020275 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS ORAL Professional Date:06/21/02ISR Number: 3938669-8Report Type:Expedited (15-DaCompany Report #NSADSS2002020576 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Risperdal PS ORAL 1mg in am and Hospitalization - Professional 2mg in pm. Initial or Prolonged 22-Feb-2006 08:20 AM Page: 1326 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/02ISR Number: 3938567-XReport Type:Expedited (15-DaCompany Report #NSADSS2002020576 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Health Risperdal Hospitalization - Professional (Risperidone) PS 1MG IN AM AND Initial or Prolonged MG IN PM Date:06/24/02ISR Number: 3938569-3Report Type:Expedited (15-DaCompany Report #NSADSS2002020275 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:06/24/02ISR Number: 3938570-XReport Type:Expedited (15-DaCompany Report #NSADSS2002020390 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (.25 Mg Professional Tablet) (Risperidone) PS ORAL 0.25 MG, ORAL Date:06/24/02ISR Number: 3938571-1Report Type:Expedited (15-DaCompany Report #NSADSS2002020396 Age:103 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Failure Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL ORAL Date:06/24/02ISR Number: 3938573-5Report Type:Expedited (15-DaCompany Report #NSADSS2002020399 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:06/24/02ISR Number: 3938574-7Report Type:Expedited (15-DaCompany Report #NSADSS2002020227 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:06/24/02ISR Number: 3939025-9Report Type:Expedited (15-DaCompany Report #2002SE03692 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Breast Pain Foreign Seroquel PS ORAL 600 MG DAILY Intervention to Galactorrhoea Health PO Prevent Permanent Professional Solian SS ORAL 800 MG DAILY Impairment/Damage Other PO Risperdal SS ORAL 4 MG DAILY PO Temesta C 22-Feb-2006 08:20 AM Page: 1327 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bactrim Forte C Zithromax C Date:06/24/02ISR Number: 3939085-5Report Type:Expedited (15-DaCompany Report #APCDSS2002000564 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Risperdal Exposure To Therapeutic Health (Unspecified) Drugs Professional (Risperidone) PS ORAL MG, DAILY , Maternal Drugs Affecting ORAL Foetus Clonazepam Pre-Eclampsia (Clonazepam) C Pregnancy Trihexyphenidyl (Trihexyphenidyl) C Date:06/24/02ISR Number: 3939088-0Report Type:Expedited (15-DaCompany Report #EMADSS2002003050 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Risperidone(Unspecif Life-Threatening Hypothermia Consumer ied) (Risperidone) PS ORAL 4 MG, DAILY, Hospitalization - Health ORAL Initial or Prolonged Professional Cinnarizine (Cinnarizine) SS ORAL 15 MG, 3 IN 1 DAILY, ORAL Aspirin(Acetylsalicy lic Acid) C Sotalol (Sotalol) C Bendrofluazide(Bendr oflumethiazide) C Date:06/24/02ISR Number: 3939091-0Report Type:Expedited (15-DaCompany Report #EMADSS2002003777 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Prolactin Increased Foreign Risperdal Life-Threatening Breast Cancer Female Health (Unspecified) Professional (Risperidone) PS ORAL 1 TO 4 MG DAILY Trazodone(Trazodone) C One-Alpha (Alfacalcidol) C Date:06/24/02ISR Number: 3939175-7Report Type:Expedited (15-DaCompany Report #EMADSS2002003717 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Foreign Risperdal (4 Mg Hospitalization - Drowning Health Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL 4 MG, DAILY, ORAL Lepticur (Tropatepine Hydrochloride) SS 10 MG, DAILY Seresta (Oxazepam) SS ORAL 50 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1328 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/02ISR Number: 3968228-2Report Type:Periodic Company Report #NSADSS2001012727 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Consumer Haldol (Injection) Initial or Prolonged Tardive Dyskinesia (Haloperidol) PS Risperdal (2 Mg Tablet) (Risperidone) SS ORAL 2 MG, DAILY, ORAL Norvasc (Amlodipine Besilate) C Vasotec (Enalapril Maleate) C Paxil (Paroxetine Hydrochloride) C Detrol (Tolterodine L-Tartrate) C Synthroid (Levothyroxine Sodium) C Premarin (Estrogens Conjugated) C Date:06/25/02ISR Number: 3939529-9Report Type:Direct Company Report #CTU 170865 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Increased Haloperidol PS Initial or Prolonged Parkinsonism Risperidone SS Date:06/25/02ISR Number: 3940121-0Report Type:Expedited (15-DaCompany Report #EMADSS2002003718 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Risperdal Blood Prolactin Increased Health (Unspecified) Platelet Count Decreased Professional (Risperidone) PS 1.5 MG NOCTE White Blood Cell Count AND 1 MG Decreased MANE. Date:06/25/02ISR Number: 3940122-2Report Type:Expedited (15-DaCompany Report #APCDSS2002000633 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Foreign Risperdal (Tablet) Depressed Level Of Health (Risperidone) PS ORAL MG, DAILY, Consciousness Professional ORAL Glucose Urine Present Quetiapine Fumarate Ketoacidosis (Quetiapine Polydipsia Fumarate) SS ORAL MG, DAILY, Weight Increased ORAL Nitrazepam (Nitrazepam) C Ethyl Loflazepate (Ethyl Loflazepate) C 22-Feb-2006 08:20 AM Page: 1329 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/02ISR Number: 3940504-9Report Type:Expedited (15-DaCompany Report #B0271033A Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Literature Paxil (Formulation Initial or Prolonged Bipolar Disorder Health Unknown) (Paroxetine Drug Interaction Professional Hydrochloride) PS SEE DOSAGE Dyskinesia TEXT Movement Disorder Risperidone Tardive Dyskinesia (Formulation Vision Blurred Unknown) (Risperidone) SS SEE DOSAGE TEXT Simvastatin C Thiamine C Folic Acid C Semisodium Valproate C Date:06/26/02ISR Number: 3940735-8Report Type:Expedited (15-DaCompany Report #EMADSS2002001788 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paraesthesia Foreign Risperdal Initial or Prolonged Health (Unspecified) Disability Professional (Risperdone) PS ORAL 1 MG, 2 IN 1 Other DAY(S), ORAL Claritine (Loratadine) C Importal (Lactitol) C Ibuprofen (Ibuprofen) C Melatonin (Melatonin) C Date:06/26/02ISR Number: 3940738-3Report Type:Expedited (15-DaCompany Report #EMADSS2002003825 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Foreign Risperdal Initial or Prolonged Leukopenia Health (Unspecified) Paranoia Professional (Risperdone) PS ORAL 2 MG, DAILY, Parkinsonism ORAL Temesta (Lorazepam) C Solian (Amisulpride) C Stilnox (Zolpidem) C Date:06/26/02ISR Number: 3940880-7Report Type:Direct Company Report #CTU0171016 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bloody Discharge Risperdal 4mg Q Hs PS 1 YR Pain Klonopin C Priapism Cogentin C 22-Feb-2006 08:20 AM Page: 1330 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/02ISR Number: 3941666-XReport Type:Expedited (15-DaCompany Report #DE9084024JUN2002 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Interaction Health Trevilor Retard Cardiomyopathy Professional (Venlafaxine Hydrochloride, Capsule, Extended Release, 0) PS ORAL DAILY DOSE 225 MG; DAILY DOSE 300 MG 8 DAY Alcohol (Ethanol, , 0) SS ORAL DAILY 1 BOTTLE OF SPIRITS, BEER Dipiperon (Pipamperone, , 0) SS ORAL DAILY DOSE 40 MG 8 DAY Risperdal (Risperidone, , 0) SS ORAL DAILY DOSE 5 MG Date:06/28/02ISR Number: 3941693-2Report Type:Expedited (15-DaCompany Report #NSADSS2002021030 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:06/28/02ISR Number: 3941906-7Report Type:Expedited (15-DaCompany Report #NSADSS2002021224 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Consumer Risperdal (0.5 Mg Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Date:06/28/02ISR Number: 3941929-8Report Type:Expedited (15-DaCompany Report #NSADSS2002021227 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 1, DAILY, ORAL Date:06/28/02ISR Number: 3942053-0Report Type:Expedited (15-DaCompany Report #NSADSS2002016745 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Risperdal (3 Mg Faecal Incontinence Professional Tablet) (Riperidone) PS 6MG IN AM, Fall 3MG AT LUNCH Myocardial Infarction AND 6MG HS Prempro (Provette/Generic/) C 22-Feb-2006 08:20 AM Page: 1331 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakoate (Valproate Semisodium) C Propanolol (Propanolol) C Paxil (Paroxetine Hydrochloride) C Aspirin (Acetylsalicylic Acid) C Oscal (Calcium Carbonate) C Benadryl (Diphenhydramine Hydrochloride) C Date:06/28/02ISR Number: 3942262-0Report Type:Expedited (15-DaCompany Report #EMADSS2002003869 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Foreign Haldol(Haloperidol) PS ORAL 6 MG, DAILY, Hospitalization - Dementia Health ORAL Initial or Prolonged Hallucination, Visual Professional Risperdal Hypotension (Tablet)(Risperidone Loss Of Consciousness ) SS ORAL 2 MG, DAILY, Restlessness ORAL Syncope Atosil (Isopromethazine Hydrochloride) SS ORAL 75 MG, DAILY, ORAL Saroten (Amitriptyline Hydrochloride) SS ORAL 50 MG, DAILY, ORAL Eunerpan(Melperone Hydrochloride) SS ORAL 45 MG, DAILY, ORAL Tavor (Lorazepam) C Date:07/01/02ISR Number: 3941987-0Report Type:Direct Company Report #CTU 171379 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Laboratory Test Abnormal Hydroxyzine PS ORAL PO X 1 Initial or Prolonged Overdose Risperidone SS Required Trazodone SS ORAL PO X 1 Intervention to Phenytoin C Prevent Permanent Phenobarbital C Impairment/Damage Paroxetine C Ranitidine C Risperidone C Trazodone C Hydroxyzine C 22-Feb-2006 08:20 AM Page: 1332 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/02ISR Number: 3942897-5Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Haldol (Tablet) Initial or Prolonged Blood Glucose Increased Health (Haloperidol) PS ORAL MG, DAILY, Blood Pressure Increased Professional ORAL Condition Aggravated Risperdal (Tablet) Delusion (Risperidone) SS ORAL SEE IMAGE Hallucination Quetiapine Fumarate Respiratory Distress (Quetiapine Fumarate) SS ORAL MG, DAILY, ORAL Hydroxyzine Pamoate (Hydroxyzine) C Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:07/01/02ISR Number: 3942900-2Report Type:Expedited (15-DaCompany Report #2002AP01772 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Seroquel PS ORAL 200 MG DAILY Blood Pressure Decreased Health PO Blood Triglycerides Professional Seroquel SS ORAL 300 MG DAILY Increased Other PO Coma Risperdal SS ORAL 2 MG DAILY PO Depressed Level Of Risperdal SS ORAL 3 MG DAILY PO Consciousness Risperdal SS ORAL 4 MG DAILY PO Diabetes Mellitus Meilax C Diabetic Ketoacidosis Benzalin C Drug Ineffective Insomnia Shock Weight Decreased Date:07/01/02ISR Number: 3943124-5Report Type:Expedited (15-DaCompany Report #FR9083624JUN2002 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Triglycerides Foreign Seresta (Oxazepam, Increased Health Tablet) PS ORAL 50 MG 1X PER Cardiac Disorder Professional 1 DAY ORAL 41 DAY Drowning Other Lepticur (Tropatepine Hydrochloride, ,0) SS ORAL 10 MG 1X PER 1 DAY ORAL 40 DAY Risperdal (Risperidone, ,0) SS ORAL 4 MG 1X PER 1 DAY ORAL 41 DAY 22-Feb-2006 08:20 AM Page: 1333 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/02ISR Number: 3943468-7Report Type:Expedited (15-DaCompany Report #EMADSS2002003949 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Foreign Risperdal (Tablet) Initial or Prolonged Health (Risperidone) PS ORAL 1, DAILY, Professional ORAL Haldol (Unspecified) (Haloperidol) SS 2.5 MG, DAILY, UNKNOWN Imap (2 Mg/Ml Injection) (Fluspirilene) SS INTRAMUSCULAR 12 MG, IM Captohexal (Captopril) C Kliogest (Kliogest) C Doxepin (Doxepin) C Diazepam Tropfen (Diazepam) C Beloc-Zok Forte (Metoprolol) C Truxal (Chlorprothixene Hydrochloride) C Cotrim (Bactrim) C Dytide (Dytide) C Norvasc (Amlodipine Besilate) C Furorese (Furosemide) C Tavegil (Clemastine) C Dexa-Polyspectran (Dexa Polyspectran N) C Date:07/01/02ISR Number: 3943824-7Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperdal (Tablet) Initial or Prolonged Blood Creatine Health (Risperidone) PS ORAL SEE IMAGE Phosphokinase Increased Professional Haldol (Tablet) Blood Glucose Increased (Haloperiodol) SS ORAL MG, DAILY, Blood Pressure Increased ORAL Condition Aggravated Quetiapine Fumarate Delusion (Quetiapine Glycosylated Haemoglobin Fumarate) SS ORAL MG, DAILY, Glycosylated Haemoglobin ORAL Increased Hydroxyzine Pamoate Hallucination (Hydroxyzine) C Hypoventilation Estazolam Insomnia (Estazolam) C Oxygen Saturation Zopiclone Decreased (Zopiclone) C Respiratory Distress Biperiden Hydrochloride (Biperiden Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1334 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/02ISR Number: 3943826-0Report Type:Expedited (15-DaCompany Report #APCDSS2002000633 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Depressed Level Of Foreign Risperdal (Tablet) Consciousness Health (Risperidone) PS ORAL MG, DAILY, Diabetic Hyperglycaemic Professional ORAL Coma Quetiapine Fumarate Insomnia (Quetiapine Ketoacidosis Fumarate) SS ORAL MG, DAILY, Malaise ORAL Polydipsia Nitrazepam Weight Increased (Nitrazepam) C Ethyl Loflazepate (Ethyl Loflazepate) C Date:07/01/02ISR Number: 3944001-6Report Type:Expedited (15-DaCompany Report #EMADSS2002003949 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Foreign Haldol (Unspecified) Initial or Prolonged Health (Haloperidol) PS 2.5 MG, DAILY Professional Risperdal (Tablet) (Risperidone) SS ORAL 1, DAILY, ORAL Imap (2 Mg/Ml Injection) (Flusprilene) SS INTRAMUSCULAR 12 MG, IM Capthohexal (Captopril) C Kliogest (Kliogest) C Doxepin (Doxepin) C Diazepam Tropfen (Diazepam) C Beloc-Zok Forte (Metoprolol) C Truxal (Chlorprothixene Hydrochloride) C Cotrim (Bactrim) C Dytide (Dytide) C Norvasc (Amlodipine Besilate) C Furorese (Furosemide) C Tavegil (Clemastine) C Dexa-Polyspectran (Dexa Polyspectran N) C Date:07/01/02ISR Number: 3996998-6Report Type:Periodic Company Report #NSADSS2002010807 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypothermia Health Reminyl (Tablet) Professional (Galantamine) PS ORAL ORAL Risperdal (Tablet) (Risperidone) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1335 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/02ISR Number: 3996999-8Report Type:Periodic Company Report #NSADSS2002010825 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Consumer Reminyl (Tablet) Anorexia (Galantamine) PS ORAL 8 MG, 2 IN 1 Confusional State DAILY, ORAL Fall Risperdal Gait Disturbance (Unspecified) Melaena (Risperidone) SS ORAL ORAL Nausea Urinary Incontinence Weight Decreased Date:07/02/02ISR Number: 3943649-2Report Type:Expedited (15-DaCompany Report #NSADSS2002021103 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Cancer Foreign Risperdal Hospitalization - Health (Unspecified) Initial or Prolonged Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 DAILY, ORAL Remeron (Mirtazapine) C Dalmane (Flurazepam Hydrochloride) C Date:07/02/02ISR Number: 3943661-3Report Type:Expedited (15-DaCompany Report #EMADSS2002003916 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Foreign Risperdal Weight Increased Health (Unspecified) Professional (Risperidone) PS ORAL 2.5 MG, DAILY, ORAL Ergenyl (Valproate Sodium) SS 1000 MG, DAILY, Date:07/02/02ISR Number: 3943690-XReport Type:Expedited (15-DaCompany Report #NSADSS2002010572 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:07/03/02ISR Number: 3944135-6Report Type:Expedited (15-DaCompany Report #NSADSS2002017197 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL SEE IMAGE Aricept (Donepezil Hydrochloride) C Tamoxifen (Tamoxifen) C 22-Feb-2006 08:20 AM Page: 1336 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/03/02ISR Number: 3944380-XReport Type:Expedited (15-DaCompany Report #PHRM2002FR00724 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Trileptal(Oxcarbazep Cholestasis Health ine) Tablet PS ORAL 450 MG, BID, Cytolytic Hepatitis Professional ORAL Vomiting Other Zoloft (Sertraline Hydrochloride) Capsule SS ORAL 1 DF, QD, ORAL Risperdal (Risperidone) Tablet SS ORAL 0.25 DF, BID, ORAL Modopar (Levodopa, Benserazide Hydrochloride) Capsule C Date:07/03/02ISR Number: 3944431-2Report Type:Expedited (15-DaCompany Report #2002AP01772 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Seroquel PS ORAL 200 MG DAILY Blood Triglycerides Health PO Increased Professional Seroquel SS ORAL 300 MG DAILY Coma Other PO Diabetic Ketoacidosis Risperdal SS ORAL 2 MG DAILY PO Insomnia Risperdal SS ORAL 3 MG DAILY PO Shock Risperdal SS ORAL 4 MG DAILY PO Weight Decreased Meilax C Benzalin C Date:07/03/02ISR Number: 3944632-3Report Type:Expedited (15-DaCompany Report #EMADSS2002002950 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Foreign Risperdal (Solution) Health (Risperidone) PS ORAL SEE IMAGE Professional Diamicron Company (Gliclazide) C Representative Glucophage (Metformin Hydrochloride) C Tegretol (Carbamazepine) C Nozinan (Levomepromazine) C Valium (Diazepam) C Tranxene (Clorazepate Dipotassium) C Teralithe (Lithium Carbonate) C Imovane (Zopiclone) C Augmentin (Amoxcillina + Clavulanico) C Rulid (Roxithromycin) C 22-Feb-2006 08:20 AM Page: 1337 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/03/02ISR Number: 3944677-3Report Type:Expedited (15-DaCompany Report #NSADSS2002021968 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Rispridone) PS ORAL ORAL Date:07/03/02ISR Number: 3944678-5Report Type:Expedited (15-DaCompany Report #NSADSS2002021636 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Risperdal Professional (Unspecified) (Risperidone) PS 1MG IN AM AND 3 MG HS Date:07/03/02ISR Number: 3944679-7Report Type:Expedited (15-DaCompany Report #NSADSS2002018957 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Health Risperdal (0.5 Mg Disease Progression Professional Tablet) Oral Intake Reduced (Risperidone) PS ORAL 0.5 MG, 2 IN 24 HOURS(S), ORAL Date:07/03/02ISR Number: 3945116-9Report Type:Expedited (15-DaCompany Report #NSADSS2002021965 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:07/05/02ISR Number: 3944485-3Report Type:Expedited (15-DaCompany Report #001-0073-M0200194 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Dilantin Suspension Initial or Prolonged Cognitive Disorder Professional (Phenytoin Sodium) PS ORAL 200 MG (100 Other Deep Vein Thrombosis MG BID), Delusion ORAL Depression Gabapentin Drug Ineffective (Gabapentin) SS 1200 MG (TID) Drug Interaction Fluphenazine Drug Level Decreased Hydrochloride SS ORAL 35 MG (TID & Screaming HS), ORAL Tardive Dyskinesia Fluoxetine Urine Calcium Increased Hydrochloride SS Risperidone SS ORAL 8 MG (4 MG, BID), ORAL Warfarin Sodium SS Fluphenazine Decanoate C ORAL 17.75 MG (EVERY 7 DAYS), ORAL Sertraline Hydrochloride C 22-Feb-2006 08:20 AM Page: 1338 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/02ISR Number: 3944489-0Report Type:Expedited (15-DaCompany Report #2002000488 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Foreign Amlodipine Initial or Prolonged Depression Health (Amlodipine) PS ORAL (DAILY), ORAL Other Hypertension Professional Cotrim (Bactrim) SS ORAL 20 MG (BID), Oedema Other ORAL Sleep Disorder Truxal Stevens-Johnson Syndrome (Chlorprothixene Urinary Tract Infection Hydrochloride) SS ORAL 50 ML (BID), ORAL Diazepam (Diazepam) SS ORAL 15 MG (TID), ORAL Furorese (Furosemide) SS ORAL ORAL Dytide H (Dyazide) SS ORAL ORAL Tafil (Alprazolam) SS ORAL ORAL Saroten (Amitriptyline Hydrochloride) SS ORAL ORAL Captohexal (Captopril) SS ORAL ORAL Haldol (Haloperidol) SS ORAL ORAL Beloc-Zok Forte (Metoprolol Succinate) SS ORAL ORAL Risperdal (Risperidone) SS ORAL ORAL Planum (Temazepam) SS ORAL ORAL Prent 400 (Acebutolol Hydrochloride) C Kliogest (Kliogest "Novo Industri") C Doneurin (Doxepin Hydrochloride) C Captogamma 25 (Captopril) C Date:07/05/02ISR Number: 3945627-6Report Type:Expedited (15-DaCompany Report #NSADSS2002021975 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL ORAL Date:07/05/02ISR Number: 3945747-6Report Type:Expedited (15-DaCompany Report #2002PK00632 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Foreign Beloc Zok PS ORAL 50 MG DAILY Initial or Prolonged Stevens-Johnson Syndrome Health PO Professional Cotrim SS ORAL 20 ML DAILY Other PO Saroten SS ORAL 70 MG DAILY PO Prent SS Planum SS 22-Feb-2006 08:20 AM Page: 1339 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Captogamma SS ORAL 25 MG BID PO Kliogest SS Imap SS 1 AMP BIMO SQ Tafil SS ORAL 0.5 MG PRN PO Doneurin SS ORAL 50 MG TID PO Diazepam SS ORAL 15 MG DAILY PO Diazepam SS ORAL 15 MG DAILY PO Haldol SS Haldol SS ORAL 10 GTT DAILY PO Truxal SS ORAL 50 ML DAILY PO Dytide H SS ORAL 16 MG DAILY PO Captohexal SS ORAL 75 MG DAILY PO Risperdal SS ORAL 4 DF DAILY PO Norvasc SS Furorese SS ORAL 20 MG DAILY PO Tavegil C Dexa Polyspectran N C Date:07/05/02ISR Number: 3945759-2Report Type:Expedited (15-DaCompany Report #EMADSS2002003949 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Foreign Risperdal (Tablet) Initial or Prolonged Health (Risperidone) PS ORAL 1, DAILY, Professional ORAL Haldol (Unspecified) (Haloperidol) SS 2.5 MG, DAILY, Imap (2 Mg/Ml Injection) (Fluspirilene) SS INTRAMUSCULAR 12 MG, IM Captohexal (Captopril) C Kliogest (Kliogest) C Doxepin (Doxepin) C Diazepam Tropfen (Diazepam) C Beloc-Zok Forte (Metoprolol) C Truxal (Chlorprothixene Hydrochloride) C Cotrim (Bactrim) C Dytide (Dytide) C Norvasc (Amlodipine Besilate) C Furorese (Furosemide) C Tavegil (Clemastine) C Dexa-Polyspectran (Dexa Polyspectran N) C 22-Feb-2006 08:20 AM Page: 1340 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/02ISR Number: 3945761-0Report Type:Expedited (15-DaCompany Report #EMADSS2001005486 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Catatonia Foreign Risperidone Dysphagia Study (Unspecified) Neuroleptic Malignant Health (Risperidone) PS PATIENT HAD Syndrome Professional PREVIOUSLY Respiratory Failure RECEIVED RISPERIDONE FROM Topiramate (Capsule) (Topiramate) SS ORAL 3 CAP, DAILY, ORAL Placebo (Placebo) SS ORAL 3 CAP, DAILY, ORAL Lithium (Lithium) SS DAATE UNSPECIFIED Lorazepam (Lorazepam) C Chloral Hydrate (Chloral Hydrate) C Diazepam (Diazepam) C Olanzapine (Olanzapine) C Senna (Senna) C Lactulose (Lactulose) C Haloperidol (Haloperidol) C Lithium Carbonate (Lithium Carbonate) C Date:07/05/02ISR Number: 3945763-4Report Type:Expedited (15-DaCompany Report #APCDSS2002000568 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sick Sinus Syndrome Foreign Risperdal (Tablet) Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Carbamazepine (Carbamazepine) C Zotepine (Zotepine) C Lithium Carbonate (Lithium Carbonate) C Date:07/05/02ISR Number: 3945765-8Report Type:Expedited (15-DaCompany Report #EMADSS2002003933 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Foreign Risperdal (Tablet) Initial or Prolonged Mucosal Haemorrhage Health (Risperidone) PS ORAL ORAL Petechiae Professional Lithionit (Lithium Platelet Count Decreased Sulfate) SS PROLONGED RELEASE 22-Feb-2006 08:20 AM Page: 1341 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/02ISR Number: 3945767-1Report Type:Expedited (15-DaCompany Report #APCDSS2002000656 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Risperdal Phosphokinase Increased Health (Unspecified) Blood Urea Abnormal Professional (Risperidone) PS ORAL ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Midodrine Hydrochloride (Midodrine Hydrochloride) C Ranitidine Hydrochloride (Ranitidine Hydrochloride) C Triazolam (Triazolam) C Sennosides (Sennosides) C Furosemide (Furosemide) C Date:07/05/02ISR Number: 3946661-2Report Type:Expedited (15-DaCompany Report #EMADSS2002003949 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Foreign Haldol (Unspecified) Initial or Prolonged Health (Haloperidol) PS 2.5 MG, DAILY Professional Risperdal (Tablet) (Risperidone) SS ORAL 1, DAILY, ORAL Imap (2 Mg/Ml Injection) (Fluspirilene) SS INTRAMUSCULAR 12 MG, IM Captohexal (Captopril) C Kliogest C Doxepin C Diazepam Tropfen C Beloc-Zok Forte (Metoprolol) C Truxal (Chlorprothixene Hydrochloride) C Cotrim (Bactrim) C Dytide C Norvasc (Amlodipine Besilate) C Furorese (Furosemide) C Tavegil (Clemastine) C Dexa-Polyspectran (Dexa Polyspectran N) C 22-Feb-2006 08:20 AM Page: 1342 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/02ISR Number: 3944193-9Report Type:Expedited (15-DaCompany Report #NSADSS2002008899 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Risperdal PS ORAL Risperdal C ORAL 1 DAY Date:07/08/02ISR Number: 3944232-5Report Type:Expedited (15-DaCompany Report #NSADSS2002019890 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hyperprolactinaemia Health Risperdal PS ORAL Pituitary Tumour Professional Date:07/09/02ISR Number: 3945613-6Report Type:Direct Company Report #CTU 171893 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Risperdal 0.5mg Muscle Rigidity (Jannsen) PS ORAL 0.5MG PO HS Muscular Weakness Temperature Regulation Disorder Date:07/09/02ISR Number: 3946985-9Report Type:Expedited (15-DaCompany Report #NSADSS2002022144 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:07/10/02ISR Number: 3945953-0Report Type:Expedited (15-DaCompany Report #B0272661A Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Shock Ventoline PS Glaxo Wellcome RESPIRATORY (INHALATION) 2PUFF As required Serevent SS Glaxo Wellcome RESPIRATORY (INHALATION) 100MCG As required Zyrtec SS Glaxo Wellcome ORAL 10MG Per day 18 DAY Depamide SS ORAL 2CAP Three times per day 26 DAY Risperdal SS ORAL 2MG per day 21 DAY Date:07/10/02ISR Number: 3947692-9Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anorexia Initial or Prolonged Blood Creatine Phosphokinase Increased Blood Pressure Increased Diabetes Mellitus Hypoventilation 22-Feb-2006 08:20 AM Page: 1343 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Oxygen Saturation Decreased Report Source Product Role Manufacturer Route Dose Duration Respiratory Distress Foreign Haldol (Tablet) Schizophrenia Health (Haloperidol) PS ORAL MG, DAILY, Professional ORAL Risperidal (Tablet) (Risperidone) SS ORAL MG, DAILY, ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL MG, DAILY, ORAL Hydroxyzine Pamoate (Hydroxyzine) C Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:07/10/02ISR Number: 3947693-0Report Type:Expedited (15-DaCompany Report #APCDSS2002000564 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Risperdal Exposure To Therapeutic Health (Risperidone) PS ORAL MG, DAILY, Drugs Professional ORAL Eclampsia Clonazepam Pregnancy (Clonazepam) C Trihexyphenidyl (Trihexyphenidyl) C Date:07/10/02ISR Number: 3947694-2Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperidal (Tablet) Initial or Prolonged Blood Creatine Health (Risperidone) PS ORAL MG, DAILY, Phosphokinase Increased Professional ORAL Blood Pressure Increased Haldol (Tablet) Diabetes Mellitus (Haloperidol) SS ORAL MG, DAILY, Hypoventilation ORAL Insomnia Quetiapine Fumarate Oxygen Saturation (Quetiapine Decreased Fumarate) SS ORAL MG, DAILY, Respiratory Distress ORAL Schizophrenia Hydroxyzine Pamoate (Hydroxyzine) C Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden 22-Feb-2006 08:20 AM Page: 1344 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Hydrochloride) C Date:07/10/02ISR Number: 3947843-6Report Type:Expedited (15-DaCompany Report #2002000734 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Risperdal Company (Risperidone) SS Representative Date:07/10/02ISR Number: 3947871-0Report Type:Expedited (15-DaCompany Report #NSADSS2002022366 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:07/11/02ISR Number: 3948230-7Report Type:Expedited (15-DaCompany Report #2002AP01772 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Seroquel PS ORAL 200 MG DAILY Blood Triglycerides Health PO Increased Professional Seroquel SS ORAL 300 MG DAILY Depressed Level Of Other PO Consciousness Risperdal SS ORAL 2 MG DAILY PO Diabetic Hyperosmolar Risperdal SS ORAL 3 MG DAILY PO Coma Risperdal SS ORAL 4 MG DAILY PO Diabetic Ketoacidosis Meilax C Insomnia Benzalin C Shock Weight Decreased Weight Increased Date:07/11/02ISR Number: 3948717-7Report Type:Expedited (15-DaCompany Report #NSADSS2002010933 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, 2 IN DAILY, ORAL Date:07/11/02ISR Number: 3948730-XReport Type:Expedited (15-DaCompany Report #NSADSS2002010933 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, 2 IN DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1345 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/02ISR Number: 3948986-3Report Type:Expedited (15-DaCompany Report #APCDSS2002000633 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Triglycerides Foreign Risperdal (Tablet) Increased Health (Risperidone) PS ORAL MG, DAILY, Diabetic Hyperglycaemic Professional ORAL Coma Quetiapine Fumarate Insomnia (Quetiapine Weight Increased Fumarate) SS ORAL MG, DAILY, ORAL Nitrazepam (Nitrazepam) C Ethyl Loflazepate (Ethyl Loflazepate) C Date:07/11/02ISR Number: 3948987-5Report Type:Expedited (15-DaCompany Report #EMADSS2002004131 Age:13 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Risperdal (Tablet) Exposure To Therapeutic Health (Risperidone) PS TRANSPLACENTAL TAKEN BY Drugs Professional MOTHER DURING Drug Withdrawal Syndrome PREGNANCY Neonatal (TRANSPLANCEN Maternal Drugs Affecting TAL) Foetus Benzodiazepine SS TRANSPLACENTAL TAKEN BY MOTHER DURING PREGNANCY(TRA NSPLANCENTAL) Melleril (Thioridazine Hydrochloride) C Serotonin (Srotonin Antagonists) C Date:07/11/02ISR Number: 3949001-8Report Type:Expedited (15-DaCompany Report #EMADSS2002004131 Age:13 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Risperdal(Tablet) Exposure To Therapeutic Health (Risperidone) PS TRANSPLACENTAL TAKEN BY Drugs Professional MOTHER DURING Drug Withdrawal Syndrome PREGNANCY Neonatal (TRANSPLACENT Maternal Drugs Affecting AL) Foetus Benzodiazepine SS TAKEN BY MOTHER DURING PREGNANCY Melleril (Thioridazine Hydrochloride) C Serotonin (Serotonin Antagonists) C 22-Feb-2006 08:20 AM Page: 1346 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/02ISR Number: 3948335-0Report Type:Expedited (15-DaCompany Report #2002050725 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Neurontin Other Overdose Literature (Gabapentin) PS 600 MG Shock Health (DAILY) Professional Risperidone SS 6 MG (DAILY) Zuclopenthixol Decanoate C Tropatepine Hydrochloride C Lorazepam C Fluphenazine Hydrochloride C Midazolam C Propofol C Remifentanil C Atracurium C Date:07/12/02ISR Number: 3948391-XReport Type:Direct Company Report #CTU 172239 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Risperdal 1 Mg PS ORAL 1 PO BID Trazodone 200 Mg C Zoloft 150 Mg C Date:07/12/02ISR Number: 3948393-3Report Type:Direct Company Report #CTU 172241 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Risperdone PS RISPERDONE 2 Heart Rate Increased MG/D Depakoate C Wellbutrin C Date:07/12/02ISR Number: 3948918-8Report Type:Expedited (15-DaCompany Report #NSADSS2002022505 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Risperdal Professional (Risperidone) PS ORAL ORAL Depakote (Valproate Semisodium) SS ORAL ORAL Date:07/12/02ISR Number: 3948970-XReport Type:Expedited (15-DaCompany Report #NSADSS2002022496 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Risperdal (Tablet) Professional (Risperidone) PS 2 MG - AM ; 4 MG - PM Sinemet (Sinemet) C Demadex (Torsemide) C Cogentin (Benzatropine Mesilate) C 22-Feb-2006 08:20 AM Page: 1347 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Potassium (Potassium) C Darvocet (Darvocet) C Lovenox (Heparin-Fraction, Sodium Salt) C Date:07/12/02ISR Number: 3948971-1Report Type:Expedited (15-DaCompany Report #NSADSS2002022503 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Health Risperdal (Tablet) Initial or Prolonged Lymphoma Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 Required DAY(S), ORAL Intervention to Trilafon Prevent Permanent (Perphenazine) C Impairment/Damage Wellbutrin (Amfebutamone Hydrochloride) C Amantadine (Amantadine) C Pamelor (Nortriptyline Hydrochloride) C Date:07/12/02ISR Number: 3949042-0Report Type:Expedited (15-DaCompany Report #001-0073-M0200194 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Dilantin Suspension Initial or Prolonged Akathisia Professional (Phenytoin Sodium) PS ORAL 200 MG (100 Other Cognitive Disorder MG, BID), Convulsion ORAL Deep Vein Thrombosis Gabapentin SS 1200 MG (TID) Delusion Fluphenazine Depression Decanoate SS ORAL 17.75 MG Drug Effect Decreased (EVERY 7 Drug Interaction DAYS), ORAL Drug Level Decreased Fluphenazine Fear Hydrochloride SS ORAL 35 MG (TID & Oral Intake Reduced HS), ORAL Protein Total Increased Warfarin Sodium SS Psychotic Disorder Fluoxetine Screaming Hydrochloride SS Tardive Dyskinesia Risperidone SS ORAL 8 MG (4 MG, Thinking Abnormal BID), ORAL Urine Calcium Increased Sertraline Weight Increased Hydrochloride C Date:07/15/02ISR Number: 3948597-XReport Type:Direct Company Report #CTU 172294 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Risperidone 1 Mg Janssen PS Janssen ORAL 2 MG DAILY ORAL Effexor Xr 150 Mg C 22-Feb-2006 08:20 AM Page: 1348 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/15/02ISR Number: 3949605-2Report Type:Expedited (15-DaCompany Report #APCDSS2002000701 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Risperidone Initial or Prolonged Facial Palsy Consumer (Unspecified) Other Herpes Zoster Company (Risperidone) PS ORAL MG, DAILY, Middle Insomnia Representative ORAL Deptran (Doxepin Hydrochloride) C Lipex (Simvastatin) C Date:07/15/02ISR Number: 3949671-4Report Type:Expedited (15-DaCompany Report #NSADSS2002018258 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (.25 Mg Professional Tablet) (Risperidone) PS ORAL 0.25 MG, DAILY, ORAL Xalatan (Latanoprost) C Ibuprofen C Aspirin (Acetylsalicylic Acid) C Vitamin E (Tocopherol) C Miacalcin (Calcitonin, Salmon) C Timoptic (Timolol Maleate) C Viatmin A (Retinol) C Aricept (Donepezil Hydrochloride) C Lorazepam C Benadryl (Diphenhydramine Hydrochloride) C Haldol (Haloperidol) C Raxanol (Morphine Sulfate) C Date:07/15/02ISR Number: 3949673-8Report Type:Expedited (15-DaCompany Report #NSADSS2002019942 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:07/15/02ISR Number: 3949674-XReport Type:Expedited (15-DaCompany Report #NSADSS2002022907 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Risperdal Professional (Unspecified) Company (Risperidone) PS ORAL 5 MG, 1 IN 24 Representative HOUR(S), ORAL 22-Feb-2006 08:20 AM Page: 1349 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/15/02ISR Number: 3949749-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02090 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deafness Neurosensory Foreign Ritalin Health (Methylphenidate Professional Hydrochloride) Other Tablet PS 25 MG, TID Risperdal (Risperidone) SS ORAL 0.5 MG, QID, ORAL Date:07/16/02ISR Number: 3949134-6Report Type:Direct Company Report #CTU 172360 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Risperdal PS ORAL 4 MG PO QHS 6 MON Initial or Prolonged Paxil SS ORAL 30 MG PO QAM 6 MON Geodon C Verapamil C Hctz C Zocor C Vistoril C Atenolol C Date:07/16/02ISR Number: 3950150-9Report Type:Expedited (15-DaCompany Report #NSADSS2002017906 Age:89 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Health Risperdal (Tablet) Disease Progression Professional (Risperidone) PS ORAL 2 MG, DAILY, ORAL Lasix (Furosemide) C Glucotrol (Glipizide) C Atenolol (Atenolol) C Lisinopril (Lisinopril) C Date:07/17/02ISR Number: 3950672-0Report Type:Expedited (15-DaCompany Report #NSADSS2002019890 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 6 MG, 1 IN 24 HOUR(S), ORAL Luvox (Fluvoxamine Maleate) C Buspar (Buspirone Hydrochloride) C Klonopin (Clonazepam) C 22-Feb-2006 08:20 AM Page: 1350 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/17/02ISR Number: 3950675-6Report Type:Expedited (15-DaCompany Report #NSADSS2002020227 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS 0.25 MG - AM 0.50 MG - PM Prevacid (Lansoprazole) C Amaryl (Glimepiride) C Prinivil (Lisinopril) C Ativan (Lorazepam) C Date:07/17/02ISR Number: 3950990-6Report Type:Expedited (15-DaCompany Report #2002AP01772 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Seroquel PS ORAL 200 MG DAILY Hospitalization - Blood Bicarbonate Health PO Initial or Prolonged Decreased Professional Seroquel SS ORAL 300 MG DAILY Blood Triglycerides Other PO Increased Risperdal SS ORAL 2 MG DAILY PO Diabetic Hyperosmolar Risperdal SS ORAL 3 MG DAILY PO Coma Risperdal SS ORAL 4 MG DAILY PO Diabetic Ketoacidosis Meilax C Hyperkalaemia Benzalin C Insomnia Shock Weight Fluctuation Date:07/17/02ISR Number: 3951386-3Report Type:Expedited (15-DaCompany Report #NSADSS2002023221 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:07/17/02ISR Number: 3951389-9Report Type:Expedited (15-DaCompany Report #NSADSS2002023225 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (1 Mg Hospitalization - Professional Tablet) Initial or Prolonged (Risperidone) PS ORAL ORAL Date:07/18/02ISR Number: 3951218-3Report Type:Expedited (15-DaCompany Report #EMADSS2002004248 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Incontinence Foreign Haldol (Haloperidol) PS Parkinson'S Disease Consumer Risperdal (Tablet) (Risperidone) SS ORAL 6 MG, DAILY, ORAL Zoloft (Sertraline Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1351 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/02ISR Number: 3951335-8Report Type:Expedited (15-DaCompany Report #APCDSS2002000663 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Risperdal PS ORAL MG, DAILY, Increased Health ORAL Aspartate Professional Paroxetine Aminotransferase Hydrochloride Increased Hydrate SS ORAL MG, DAILY, Blood Creatine ORAL Phosphokinase Increased Naftopidil C Blood Lactate Etizolam C Dehydrogenase Increased Magnesium Oxide C Condition Aggravated Pranlukast C Cytomegalovirus Infection Urosodesoxycholic Depression Acid C Hallucination, Auditory Bromazepam C Psychiatric Symptom Tinnitus Date:07/18/02ISR Number: 3951338-3Report Type:Expedited (15-DaCompany Report #APCDSS2002000633 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Triglycerides Foreign Risperdal PS ORAL MG, DAILY, Increased Health ORAL Diabetic Hyperglycaemic Professional Quetiapine Fumarate Coma (Quetiapine Diabetic Ketoacidosis Fumarate) SS ORAL MG, DAILY, Insomnia ORAL Weight Decreased Ethyl Loflazepate Weight Increased (Ethyl Loflazepate) C Nitrazepam (Nitrazepam) C Date:07/18/02ISR Number: 3951343-7Report Type:Expedited (15-DaCompany Report #APCDSS2002000696 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Conjunctival Oedema Foreign Risperidone PS ORAL 0.5 MG, 2 IN Intraocular Pressure Health 1 DAILY, ORAL Increased Professional Promethazine Vision Blurred (Promethazine) C Visual Acuity Reduced Chuan Xiling C Visual Disturbance Xi Demei C Vitreous Disorder Date:07/18/02ISR Number: 3951358-9Report Type:Expedited (15-DaCompany Report #EMADSS2002004248 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinsonism Foreign Risperdal Consumer (Risperidone) PS ORAL 6 MG, DAILY, ORAL Haldol (Haloperidol) SS Zoloft (Sertraline Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1352 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/02ISR Number: 3951410-8Report Type:Expedited (15-DaCompany Report #NSADSS2002023383 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 3 MG, 1 IN 1 NIGHT(S), ORAL Date:07/18/02ISR Number: 3951602-8Report Type:Expedited (15-DaCompany Report #EMADSS2002004275 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neoplasm Foreign Risperdal (2 Mg Normochromic Normocytic Health Tablet) Anaemia Professional (Risperidone) PS ORAL 2 MG, DAILY, ORAL Date:07/18/02ISR Number: 3951619-3Report Type:Expedited (15-DaCompany Report #EMADSS2002004243 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal (1mg Initial or Prolonged Electrocardiogram Qrs Health Tablet) Complex Abnormal Professional (Risperidone0 PS ORAL 1 MG, DAILY, Extrapyramidal Disorder ORAL Fall Tranxene Head Injury (Clorazepate Hypochloraemia Dipotassium) SS ORAL 30 MG , Hypoglycaemia DAAILY, ORAL Hypomagnesaemia Deroxat (Paroxetine Hyponatraemia Hydrochloride) SS ORAL 20 MG, DAILY, Hypophosphataemia ORAL Hypothermia Leukopenia Loss Of Consciousness Posture Abnormal Subdural Haematoma Supraventricular Tachycardia Tachycardia Date:07/18/02ISR Number: 3951928-8Report Type:Expedited (15-DaCompany Report #EMADSS2002004273 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Cirrhosis Foreign Risperdal (2 Mg Initial or Prolonged Hepatic Steatosis Health Tablet) Influenza Professional (Risperidone) PS ORAL 4 MG , DAILY, ORAL Cipramil (Citalopram) SS ORAL Valproate (Valproate Sodium) C 22-Feb-2006 08:20 AM Page: 1353 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/02ISR Number: 3951513-8Report Type:Expedited (15-DaCompany Report #PHBS2002AU08184 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Foreign Methylphenidate Initial or Prolonged Dysphonia Literature (Methylphenidate Dyspnoea Health Hydrochloride) Dystonia Professional Unknown PS 10 MG/DAY, Extrapyramidal Disorder Other Risperidone Joint Stiffness (Risperidone) SS 1 MG, BID, Movement Disorder Sertraline Muscle Twitching (Sertraline) SS 25 MG/DAY, Morphine (Morphine) SS INTRAVENOUS INTRAVENOUS Ketorolac (Ketorolac) SS Tropisetron (Tropisetron Hydrochloride) Unknown SS Date:07/22/02ISR Number: 3952516-XReport Type:Expedited (15-DaCompany Report #NSADSS2002023730 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Foreign Risperdal (Tablet) Initial or Prolonged Cyanosis Literature (Risperidone) PS ORAL ORAL Dyspnoea Health Haldol (Unspecified) Lung Disorder Professional (Haloperidol) C Pco2 Decreased Sulpiride Pleural Effusion (Sulpiride) C Po2 Decreased Pulmonary Hypertension Pulmonary Infarction Pyrexia Tachycardia Date:07/23/02ISR Number: 3951801-5Report Type:Direct Company Report #CTU 172744 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Risperdal 0.25mg Bid Intervention to Phosphokinase Increased (Janssen) PS Janssen ORAL 0.25MG PO BID Prevent Permanent Muscle Spasms Taztinal C Impairment/Damage Pseudoephedrine C Albuterol C Neurontin C Topamax C Date:07/23/02ISR Number: 3952877-1Report Type:Expedited (15-DaCompany Report #EMADSS2002003475 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blepharospasm Foreign Risperdal (1 Mg Health Tablet) Professional (Risperidone) PS ORAL SEE IMAGE, ORAL Antadys (Flurbiprofen) C Lodine (Etodolac) C 22-Feb-2006 08:20 AM Page: 1354 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/02ISR Number: 3952895-3Report Type:Expedited (15-DaCompany Report #S02-GER-01443-01 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Cirrhosis Foreign Cipramil (Citalopram Hepatic Steatosis Health Hydrobromide) PS ORAL 40 MG QD PO Professional Risperdal Other (Risperidone) SS Valproinsaure (Valproic Acid) SS Date:07/23/02ISR Number: 3952965-XReport Type:Expedited (15-DaCompany Report #EMADSS2002004319 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Foreign Risperdal Initial or Prolonged Extrapyramidal Disorder Health (Unspecified) Pneumonia Aspiration Professional (Risperidone) PS ORAL ORAL Respiratory Distress Haldol Decanoate (Injection) (Haloperidol Decanoate) SS INTRAMUSCULAR 50 MG, 5 IN 3 WEEK(S), IM Solian (Amisulpride) C Date:07/23/02ISR Number: 3953736-0Report Type:Expedited (15-DaCompany Report #NSADSS2002023573 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 1.5 TABLET, 1 IN 1 DAY(S), ORAL Date:07/23/02ISR Number: 3953737-2Report Type:Expedited (15-DaCompany Report #NSADSS2002023387 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 2 IN 24 HOUR(S), ORAL Date:07/23/02ISR Number: 3953738-4Report Type:Expedited (15-DaCompany Report #NSADSS2002016585 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Concomitant Disease Health Risperdal Hospitalization - Progression Professional (Unspecified) Initial or Prolonged Respiratory Arrest (Risperidone) PS 5 MG AM / 7MG PM 22-Feb-2006 08:20 AM Page: 1355 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/02ISR Number: 3953493-8Report Type:Expedited (15-DaCompany Report #NSADSS2002023939 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:07/25/02ISR Number: 3953089-8Report Type:Direct Company Report #CTU 172927 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Risperdal Janssen PS Janssen ORAL 2MG BID ORAL Respiratory Arrest Primidone SS ORAL 300MG QHS ORAL Date:07/25/02ISR Number: 3954196-6Report Type:Expedited (15-DaCompany Report #NSADSS2002023946 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Discharge Health Risperdal Breast Mass Professional (Risperidone) PS DOSE RANGE 0.75 MG - 0.5 MG DAILY Lipitor (Atorvastatin) C Date:07/25/02ISR Number: 3954199-1Report Type:Expedited (15-DaCompany Report #NSADSS2002017078 Age:99 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:07/26/02ISR Number: 3955353-5Report Type:Expedited (15-DaCompany Report #EMADSS2002001975 Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal Initial or Prolonged Hypotension Health (Unspecified) Hypothermia Professional (Risperidone) PS Hypothyroidism Topamax (Topiramate) SS Epanutin (Phenytoin Sodium) C Tegretol (Carbamazepine) C Serenance (Haloperidol) C Atarax (Hydroxyzine Hydrochloride) C Valium (Diazepam) C 22-Feb-2006 08:20 AM Page: 1356 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/02ISR Number: 3955355-9Report Type:Expedited (15-DaCompany Report #EMADSS2002004430 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Risperdal (3 Mg Decreased Activity Health Tablet) Dizziness Professional (Risperidone) PS ORAL 3 MG, DAILY, Electrocardiogram Qt ORAL Prolonged Haldol (Unspecified) Malaise (Haloperidol) SS ORAL 3 MG, DAILY, ORAL Biperiden (Biperiden) C Date:07/26/02ISR Number: 3955356-0Report Type:Expedited (15-DaCompany Report #EMADSS2002004430 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Haldol (Unspecified) Decreased Activity Health (Haloperidol) PS ORAL 3 MG, DAILY, Dizziness Professional ORAL Electrocardiogram Qt Risperdal (3 Mg Prolonged Tablet) Malaise (Risperidone) SS ORAL 3 MG, DAILY, ORAL Biperiden (Biperiden) C Date:07/26/02ISR Number: 3988651-XReport Type:Periodic Company Report #NSADSS2002013845 Age:3.5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Somnolence Consumer Risperdal (1 Mg/Ml Initial or Prolonged Health Solution) Professional (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAILY, ORAL Date:07/29/02ISR Number: 3956118-0Report Type:Expedited (15-DaCompany Report #NSADSS2002024630 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAILY, ORAL Date:07/29/02ISR Number: 3956119-2Report Type:Expedited (15-DaCompany Report #NSADSS2002024400 Age:90 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1357 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/02ISR Number: 3956121-0Report Type:Expedited (15-DaCompany Report #NSADSS2002024396 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (4 Mg Professional Tablet) (Risperidone) PS ORAL 4 MG, 1 IN 24 HOUR(S), ORAL Date:07/29/02ISR Number: 3956173-8Report Type:Expedited (15-DaCompany Report #APCDSS2002000663 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Risperdal (Tablet) Increased Health (Risperidone) PS ORAL MG, DAILY, Aspartate Professional ORAL Aminotransferase Paroxetine Increased Hydrochloride Blood Creatine Hydrate (Paroxetine Phosphokinase Increased Hydrochloride) SS ORAL MG, DAILY, Blood Lactate ORAL Dehydrogenase Increased Naftopidil Condition Aggravated (Naftopidil) C Cytomegalovirus Infection Etizolam (Etizolam) C Depression Magnesium Oxide Laboratory Test Abnormal (Magnesium Oxide) C Psychiatric Symptom Pranlukast Rhinitis Allergic (Pranlukast) C Tinnitus Ursodesoxycholic Acid (Ursodeoxycholic Acid) C Bromazepam (Bromazepam) C Date:07/29/02ISR Number: 3956174-XReport Type:Expedited (15-DaCompany Report #NSADSS2002024204 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Temperature Regulation Foreign Risperidal Disorder Consumer (Risperidone) PS Health Professional Date:07/29/02ISR Number: 3956811-XReport Type:Expedited (15-DaCompany Report #FR9123624JUL2002 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypokalaemia Health Seresta (Oxazepam, Initial or Prolonged Hyponatraemia Professional Tablet) PS ORAL 50 MG 1X PER Other Status Epilepticus Other 1 DAY 30 DAY Deroxat (Paroxetine Hydrochloride, 0) SS ORAL 20 MG 1X PER 1 DAY 30 DAY Parkinane Lp (Trihexyphenidyl, Capsule, Sustained Release, 0) SS ORAL 5 MG 1X PER 2 DAY 22-Feb-2006 08:20 AM Page: 1358 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal (Risperidone, 0) SS ORAL 2 MG 1X PER 1 DAY Date:07/30/02ISR Number: 3956844-3Report Type:Expedited (15-DaCompany Report #A205753 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Health Hydroxyzine Intervention to Professional (Hydroxyzine) PS ORAL 50 MG (BID), Prevent Permanent Company ORAL Impairment/Damage Representative Ziprasidone (Ziprasidone) SS ORAL 80 MG (BID), ORAL Risperidal (Risperidone) SS 4 MG (HS) Paxil (Paroxetine Hydrochloride) SS Tenormin (Atenolol) (Atenolol) C Hydrochlorothiazide (Hydrochlorothiazide ) C Lescol (Fluvastatin) (Fluvastatin Sodium) C Zocor (Simvastatin) (Simvastatin) C Unspecified Medications (All Other Therapeutic Products) C Date:07/31/02ISR Number: 3957089-3Report Type:Expedited (15-DaCompany Report #02P-056-0196470-00 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Phosphorus Foreign Tranxene Initial or Prolonged Decreased Other (Clorazepate Bradycardia Dipotassium) Electrocardiogram Qrs (Clorazepate Complex Prolonged Dipotassium) PS ORAL 30 MG, 1 IN 1 Electrocardiogram Qt D, PER ORAL Prolonged Risperidone SS ORAL 1 MG, 1 IN 1 Extrapyramidal Disorder D, PER ORAL Fall Paroxetine Head Injury Hydrochloride SS ORAL 20 MG, 1 IN 1 Hypocalcaemia D, PER ORAL Hypochloraemia Hypoglycaemia Hypomagnesaemia Hyponatraemia Hypothermia Leukopenia Loss Of Consciousness Subdural Haematoma Supraventricular Tachycardia Tachycardia 22-Feb-2006 08:20 AM Page: 1359 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/02ISR Number: 3957440-4Report Type:Expedited (15-DaCompany Report #EMADSS2002002889 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal Drug Effect Decreased Health (Unspecified) Leukopenia Professional (Risperidone) PS ORAL 6 MG, NIGHT (S), ORAL Betahistine (Betahistine) C Hydroxyzide (Hydroxyzine) C Depixol (Flupentixol Decanoate) C Venlafaxine (Venlafaxine) C Bendrofluazide Bendroflumethiazide) C Procyclidine (Procyclidine) C Date:08/01/02ISR Number: 3956265-3Report Type:Direct Company Report #CTU 173332 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blood Glucose Increased Quetiapine 200 Mg Glycosylated Haemoglobin Zeneca PS Zeneca ORAL 400 MG BID Increased ORAL Risperidone 4 Mg Jansen SS Jansen ORAL 10 MG QHS ORAL Divalproex C Atenolol C Dyazide C Atorvastatin C Cardizem C Lisinopril C Date:08/01/02ISR Number: 3957666-XReport Type:Expedited (15-DaCompany Report #NSADSS2002023730 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arteriogram Abnormal Foreign Risperdal (Tablet) Initial or Prolonged Blood Pressure Decreased Literature (Risperidone) PS ORAL ORAL Cyanosis Health Sulpiride Dyspnoea Professional (Sulpiride) SS Pco2 Decreased Haldol (Unspecified) Pleural Effusion (Haloperidol) C Po2 Decreased Pulmonary Hypertension Pulmonary Infarction Pyrexia Tachycardia 22-Feb-2006 08:20 AM Page: 1360 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/02ISR Number: 3957671-3Report Type:Expedited (15-DaCompany Report #EMADSS2001006219 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal (Tablet) Disability Gait Disturbance Health (Risperidone) PS ORAL SEE IMAGE Lower Respiratory Tract Professional Zopiclone Infection Company (Zopiclone) C Mobility Decreased Representative Date:08/01/02ISR Number: 3957747-0Report Type:Expedited (15-DaCompany Report #NSADSS2002019181 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:08/01/02ISR Number: 3957750-0Report Type:Expedited (15-DaCompany Report #NSADSS2002020399 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Health Risperdal (Tablet) Ankle Fracture Professional (Risperidone) PS ORAL ORAL Arterial Occlusive Dilantin (Phenytoin Disease Sodium) C Back Pain Lamictal Coagulopathy (Lamotrigine) C Epilepsy Intestinal Ischaemia Night Sweats Pulmonary Embolism Pulse Absent Thrombosis Date:08/01/02ISR Number: 3958063-3Report Type:Expedited (15-DaCompany Report #NSADSS2002024828 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Consumer Risperdal Initial or Prolonged (Risperidone) PS ORAL ORAL Date:08/01/02ISR Number: 3958064-5Report Type:Expedited (15-DaCompany Report #NSADSS2002025226 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 2 IN 24 HOUR(S), ORAL Date:08/01/02ISR Number: 3958065-7Report Type:Expedited (15-DaCompany Report #NSADSS2002024997 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Consumer Risperdal (Tablet) Health (Risperidone) PS ORAL 5, DAILY, Professional ORAL 22-Feb-2006 08:20 AM Page: 1361 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/02ISR Number: 3958215-2Report Type:Expedited (15-DaCompany Report #2002051969 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Neurontin Initial or Prolonged Phosphokinase Increased Professional (Gabapentin) PS ORAL 400 MG(TID), Other ORAL Risperidone SS ORAL ORAL Topiramate C Salbutamol C Pseudoephedrine Hydrochloride C Paracetamol C Date:08/01/02ISR Number: 3958556-9Report Type:Expedited (15-DaCompany Report #A202900 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Amenorrhoea Health Zoloft Tablets PS ORAL DAILY:ORAL Intervention to Anxiety Professional Neurontin SS ORAL 1600.00 MG Prevent Permanent Mood Swings TOTAL:BID:ORA Impairment/Damage Neutropenia L Red Blood Cell Count Risperdal SS 2.00 MG Decreased TOTAL:DAILY Tearfulness Depakote C White Blood Cell Count Benadryl C Decreased Xanax C Date:08/02/02ISR Number: 3957150-3Report Type:Expedited (15-DaCompany Report #FLUV00302000457 Age:0 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Anaemia Foreign Depromel Taken By Complications Of Maternal Health Mother (Fluvoxamine Exposure To Therapeutic Professional Maleate) PS ORAL 25 MG DAILY Drugs Other PO, 50 MG Convulsion Neonatal DAILY PO, 50 Facial Dysmorphism MG DAILY PL, Feeding Disorder Neonatal 100 MG DAILY Joint Stiffness Risperdal Taken By Lactic Acidosis Mother (Risperidone) SS PARENTERAL 1 MG DAILY PL Masked Facies Depas Taken By Maternal Drugs Affecting Mother (Etizolam) SS PARENTERAL 0.5 MG DAILY Foetus PL, 0.5 MG Microcephaly DAILY PL, Neonatal Disorder 0.5 MG DAILY Pregnancy PL Small For Dates Baby Kamishouyousan C Treatment Noncompliance Seroquel (Seroquel) C Ferromia (Ferrous Citrate) C Vitamedin (Pyroxidine) C Aftach (Triamcinolone Acetonide) C 22-Feb-2006 08:20 AM Page: 1362 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/02ISR Number: 3960453-XReport Type:Periodic Company Report #2001AP05228 Age:24 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Amitriptylline PS Health Desipramine SS Professional Risperidone SS Date:08/02/02ISR Number: 3961078-2Report Type:Periodic Company Report #NSADSS2001002219 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal Tardive Dyskinesia Professional (Risperidone) PS ORAL SEE IMAGE, Company ORAL Representative Zyprexa(Olanzapine) C Date:08/02/02ISR Number: 3961079-4Report Type:Periodic Company Report #NSADSS2002017547 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Risperdal(Tablet)(Ri Initial or Prolonged Professional speridone) PS 2MG IN AM AND Disability 3MG IN PM Apap(Paracetamol) C Lorazepam(Lorazepam) C Date:08/02/02ISR Number: 3961081-2Report Type:Periodic Company Report #NSADSS2002017534 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Health Risperdal(Risperidon Initial or Prolonged Tachycardia Professional e) PS ORAL ORAL Date:08/02/02ISR Number: 3961083-6Report Type:Periodic Company Report #NSADSS2002017529 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Consumer Risperdal(Tablet)(Ri Initial or Prolonged speridone) PS ORAL 5 MG, DAILY, ORAL Date:08/02/02ISR Number: 3961085-XReport Type:Periodic Company Report #NSADSS2002017319 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Consumer Risperdal Initial or Prolonged Dyskinesia (Risperidone) PS ORAL ORAL Injury Somnolence 22-Feb-2006 08:20 AM Page: 1363 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/02ISR Number: 3961087-3Report Type:Periodic Company Report #NSADSS2002016742 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal(Tablet) Professional (Risperidone) PS ORAL ORAL Date:08/02/02ISR Number: 3961089-7Report Type:Periodic Company Report #NSADSS2002016388 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Initial or Prolonged Syndrome Professional (Risperidone) PS ORAL ORAL Company Representative Date:08/02/02ISR Number: 3961090-3Report Type:Periodic Company Report #NSADSS2002015990 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Risperdal Prolonged Professional (Risperidone) PS ORAL ORAL Cogentin(Benzatropin e Mesilate) C Date:08/02/02ISR Number: 3961094-0Report Type:Periodic Company Report #NSADSS2002000601 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Risperdal (0.5mg Syndrome Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 3 IN 1 DAY(S), ORAL Haloperidol (Haloperidol) C Depakote (Valproate Semisodium) C Plavix (Clopidogrel Sulfate) C Protonix (Pantoprazole) C Flomax (Morniflumate) C Folic Acid (Folic Acid) C Date:08/02/02ISR Number: 3961095-2Report Type:Periodic Company Report #NSADSS2001036613 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Unspecified) (Risperidone) PS 1.5 TO 2.5 MG DAILY Effexor Xr (Venlafaxine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1364 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gabapentin (Gabapentin) C Klonopin (Clonazepam) C Lamictal (Lamotrigine) C Haldol (Unspecified) (Haloperidol) C Date:08/02/02ISR Number: 3961096-4Report Type:Periodic Company Report #NSADSS2001036550 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal (Tablet) Anaemia (Risperidone) PS ORAL 1 MG, 1 IN 24 Galactorrhoea HOUR(S), Purpura ORAL; Weight Increased 3, DAILY, ORAL Lithium (Lithium) C Date:08/02/02ISR Number: 3961097-6Report Type:Periodic Company Report #NSADSS2001025267 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Endocrine Disorder Professional (Unspecified) Hyperprolactinaemia (Risperidone) PS HIGHEST DOSE Suicide Attempt RECEIVED Weight Increased DURING THERAPY WAS 7 MG DAILY Anafranil (Clomipramine Hydrochloride) C Elavil (Amitriptyline Hydrochloride) C Topamax (Topiramate) C Date:08/02/02ISR Number: 3961098-8Report Type:Periodic Company Report #NSADSS2001023905 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ketosis Health Risperdal Professional (Unspecified) (Risperidone) PS 1-2 MG DAILY Wellbutrin (Amfebutamone Hydrochloride) C Date:08/02/02ISR Number: 3961099-XReport Type:Periodic Company Report #NSADSS2001023770 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Professional (Unspecified) 22-Feb-2006 08:20 AM Page: 1365 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) PS ORAL ORAL Date:08/02/02ISR Number: 3961100-3Report Type:Periodic Company Report #NSADSS2001013191 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Health Risperdal (2 Mg Initial or Prolonged Hypotension Professional Tablets) Somnolence (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY(S), ORAL Thorazine (Chlorpromazine Hydrochloride) C Carbamazepine (Carbamazepine) C Date:08/02/02ISR Number: 3961101-5Report Type:Periodic Company Report #NSADSS2002014675 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Initial or Prolonged Syndrome Professional (Unspecified) (Risperidone) PS 7, DAILY Date:08/02/02ISR Number: 3961102-7Report Type:Periodic Company Report #NSADSS2002014912 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspiration Consumer Risperdal (1 Mg Initial or Prolonged Atrial Fibrillation Tablet) Condition Aggravated (Risperidone) PS ORAL 1 MG, 1 IN 1 Dysphagia DAY(S), ORAL Pneumonia Date:08/02/02ISR Number: 3961103-9Report Type:Periodic Company Report #NSADSS2002015641 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperdal Initial or Prolonged Hypotension Professional (Unspecified) (Risperidone) PS ORAL 2 MG, 1 IN 1 DAY(S), ORAL Haldol (Haloperidol) SS ORAL ORAL Date:08/02/02ISR Number: 3961113-1Report Type:Periodic Company Report #NSADSS2002009993 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Risperdal (1 Mg Initial or Prolonged Gastritis Professional Tablet) Urinary Incontinence (Risperidone) PS ORAL 1 MG, 3 IN Vomiting DAILY, ORAL Depakote (Valproate Semisodium) C Trileptal (Oxcarbazepine) C 22-Feb-2006 08:20 AM Page: 1366 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/02ISR Number: 3961114-3Report Type:Periodic Company Report #NSADSS2002011129 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal (Tablet) Initial or Prolonged Syndrome Professional (Risperidone) PS ORAL ORAL Company Representative Date:08/02/02ISR Number: 3961115-5Report Type:Periodic Company Report #NSADSS2002011268 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depersonalisation Consumer Risperdal (Tablet) Initial or Prolonged Dizziness (Risperidone) PS 1-4 MG DAILY Ejaculation Failure Haldol (Haloperidol) C Feeling Of Body Paxil (Paroxetine Temperature Change Hydrochloride) C Hyperhidrosis Motrin (Ibuprofen) C Injury Nausea Speech Disorder Date:08/02/02ISR Number: 3961116-7Report Type:Periodic Company Report #NSADSS2002011428 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Consumer Risperdal (Tablet) Initial or Prolonged Fatigue (Risperidone) PS ORAL 2 MG, 2 IN Phlebitis DAILY, ORAL Pulmonary Embolism Trazodone (Trazodone) C Depakote (Valproate Semisodium) C Lopressor (Metoprolol Tartrate) C Date:08/02/02ISR Number: 3961117-9Report Type:Periodic Company Report #NSADSS2002011598 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal ( 1 Mg Professional Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAILY, ORAL Date:08/02/02ISR Number: 3961118-0Report Type:Periodic Company Report #NSADSS2002011740 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Risperdal (Tablet) Initial or Prolonged Anxiety (Risperidone) PS ORAL 6 MG, DAILY, ORAL; SEE IMAGE Proloxin (Fluphenazine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1367 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/02ISR Number: 3961119-2Report Type:Periodic Company Report #NSADSS2002011743 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal (.25 Mg Professional Tablet) (Risperidone) PS ORAL 0.25 MG, 2 IN 1 DAILY, ORAL Ritalin (Methylphenidate Hydrochloride) C Clonidine (Clonidine) C Zarontin (Ethosuximide) C Tegretol (Carbamazepine) C Date:08/02/02ISR Number: 3961120-9Report Type:Periodic Company Report #NSADSS2002013214 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Health Risperdal (Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL 6 MG, DAILY, ORAL Zoloft (Sertraline Hydrochloride) C Clonidine (Clonidine) C Date:08/02/02ISR Number: 3961121-0Report Type:Periodic Company Report #NSADSS2002013662 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Professional (Unspecified) Company (Risperidone) PS ORAL ORAL Representative Date:08/02/02ISR Number: 3961123-4Report Type:Periodic Company Report #NSADSS2002014427 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Risperidal (Tablet) Initial or Prolonged Coordination Abnormal (Risperidone) PS ORAL 0.25 MG, Salivary Hypersecretion DAILY, ORAL Somnolence Date:08/02/02ISR Number: 3961125-8Report Type:Periodic Company Report #NSADSS2002006313 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Risperdal (3 Mg Insomnia Tablet) Oedema Mouth (Risperidone) PS ORAL 3 MG, 2 IN 1 Salivary Hypersecretion DAILY, ORAL Weight Increased Depakote (Valproate Semisodium SS ORAL 500 MG, 3 IN 22-Feb-2006 08:20 AM Page: 1368 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 DAILY, ORAL Date:08/02/02ISR Number: 3961126-XReport Type:Periodic Company Report #NSADSS2002006679 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Risperdal (3 Mg Tablet) Risperidone) PS ORAL 3 MG, 2 IN 1 DAILY, ORAL Zyprexa (Olanazpine) C Depakote (Valproate Semisodium) C Vasotec (Enalapril Maleate) C Synthroid (Levothyroxine Sodium) C Date:08/02/02ISR Number: 3961128-3Report Type:Periodic Company Report #NSADSS2002006818 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 6 MG, DAILY, Company ORAL Representative Date:08/02/02ISR Number: 3961130-1Report Type:Periodic Company Report #NSADSS2002006987 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Risperdal (Tablet) Delirium Professional Risperidone) PS ORAL 2 MG, 3 IN 1 Stupor DAILY, ORAL 4 MG,1 IN 1 NIGHT (S), ORAL Depakote (Valproate Semisodium) C Lithium (Lithium) C Date:08/02/02ISR Number: 3961131-3Report Type:Periodic Company Report #NSADSS2002007412 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal Initial or Prolonged (Unspecified) (Risperidone) PS ORAL ORAL Vasotec (Enalapril Maleate) C Eskalith (Lithium Carbonate) C Lorazepam (Lorazepam) C Trileptal (Oxcarbazepine) C Seroquel (Seroquel) C Glucophage 22-Feb-2006 08:20 AM Page: 1369 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Metformin Hydrochloride) C Date:08/02/02ISR Number: 3961133-7Report Type:Periodic Company Report #NSADSS2002008164 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Health Risperdal Professional (Unspecified) Company (Risperidone) PS ORAL 0.5 MG, Representative DAILY, ORAL Date:08/02/02ISR Number: 3961135-0Report Type:Periodic Company Report #NSADSS2002008366 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Unspecified)( Company Risperidone) PS ORAL ORAL Representative Seroquel (Seroquel) SS ORAL ORAL Date:08/02/02ISR Number: 3961137-4Report Type:Periodic Company Report #NSADSS2002008610 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apathy Health Risperdal (1 Mg Hypotonia Professional Tablet) Oculogyration (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAILY, ORAL Zantac (Ranitidine Hydrochloride) C Depakote (Valproate Semisodium) C Dulcolax (Bisacodyl) C Heparin Sodium (Heparin Sodium) C Amiodarone (Amiodarone) C Date:08/02/02ISR Number: 3961139-8Report Type:Periodic Company Report #NSADSS2002008721 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Suicide Attempt Risperdal (1 Mg Tablet) Risperidone) PS ORAL 1 MG, 1 IN 24 HOUR (S), ORAL Zoloft (Sertraline Hydrochloride) C Date:08/02/02ISR Number: 3961140-4Report Type:Periodic Company Report #NSADSS2002009374 Age: Gender:Male I/FU:I Outcome PT Report Source Other Condition Aggravated Health Convulsion Professional Company 22-Feb-2006 08:20 AM Page: 1370 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Risperdal (0.5 Mg Tablet) Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Date:08/02/02ISR Number: 3961143-XReport Type:Periodic Company Report #NSADSS2002003957 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal Initial or Prolonged Professional (Unspecified) Company (Risperidone) PS ORAL 1.5 MG, 1 IN Representative 1 NIGHT(S), ORAL Remeron (Mirtazapine) SS 7.5 MG AT BEDTIME AS NEEDED Date:08/02/02ISR Number: 3961144-1Report Type:Periodic Company Report #NSADSS2002004000 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Consumer Risperdal (0.5 Mg Tablet) (Risperidone) PS ORAL 0.5 MG 1 TIME(S), ORAL Date:08/02/02ISR Number: 3961145-3Report Type:Periodic Company Report #NSADSS2002004184 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Consumer Risperdal (Tablet) Initial or Prolonged (Risperidone) PS ORAL SEE IMAGE Date:08/02/02ISR Number: 3961146-5Report Type:Periodic Company Report #NSADSS2002004432 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Syncope Consumer Risperdal Initial or Prolonged Tremor (Unspecified) (Risperidone) PS ORAL 5 MG, DAILY, ORAL Xanax (Alprazolam) C Darvocet (Darvocet) C Paxil (Paroxetine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1371 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/02ISR Number: 3961147-7Report Type:Periodic Company Report #NSADSS2002004722 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal (Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL UNK, ORAL Depakote (Valproate Semisodium) C Date:08/02/02ISR Number: 3961148-9Report Type:Periodic Company Report #NSADSS2002004978 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL 4 MG, 1 IN 1 NIGHT (S), ORAL Paxil (Paroxetine Hydrochloride) C Date:08/02/02ISR Number: 3961149-0Report Type:Periodic Company Report #NSADSS2002005523 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Risperdal (Tablet) Initial or Prolonged Professional (Risperidone) PS ORAL SEE IMAGE Zyprexa (Olanzapine) C Date:08/02/02ISR Number: 3961150-7Report Type:Periodic Company Report #NSADSS2002005560 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal (3 Mg Hypertension Professional Tablet) Weight Increased (Risperidone) PS ORAL 3 MG, 2 IN 1 NIGHT (S), ORAL Date:08/02/02ISR Number: 3961152-0Report Type:Periodic Company Report #NSADSS2002005765 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Risperdal (0.5 Mg Initial or Prolonged Hyperglycaemia Tablet) Pneumonia (Risperidone) PS ORAL 0.5 MG, 1 IN NIGHT(S), ORAL Date:08/02/02ISR Number: 3961153-2Report Type:Periodic Company Report #NSADSS2002005936 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Risperdal Initial or Prolonged Influenza Like Illness Professional (Unspecified) Pneumonia (Risperidone) PS ORAL UNK, ORAL 22-Feb-2006 08:20 AM Page: 1372 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/02ISR Number: 3961161-1Report Type:Periodic Company Report #NSADSS2002001145 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Health Risperdal Professional (Risperidone) PS ORAL 7 MG, 1 IN 1 DAILY, ORAL Lithobid (Lithium Carbonate) C Trazodone (Trazodone) C Date:08/02/02ISR Number: 3961162-3Report Type:Periodic Company Report #NSADSS2002001308 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal (Tablet) Initial or Prolonged Syndrome Professional (Risperidone) PS ORAL 0.5 MG, 1 IN Disability Thinking Abnormal 1 NIGHT(S), ORAL 1 YR Date:08/02/02ISR Number: 3961171-4Report Type:Periodic Company Report #NSADSS2002001944 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Risperdal (1 Mg Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 1 NIGHT(S), ORAL Carbidopa/ Levodopa (Sinemet) C Mirapex (Pramipexole Dihydrochloride) C Date:08/02/02ISR Number: 3961173-8Report Type:Periodic Company Report #NSADSS2002001949 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal Initial or Prolonged (Risperidone) PS ORAL ORAL Date:08/02/02ISR Number: 3961175-1Report Type:Periodic Company Report #NSADSS2002002335 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Injury Health Risperdal Initial or Prolonged Professional (Risperidone) PS ORAL 4 MG, 1 IN 1 NIGHT(S), ORAL Date:08/02/02ISR Number: 3961176-3Report Type:Periodic Company Report #NSADSS2002002337 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gynaecomastia Consumer Risperdal (Tablet) Initial or Prolonged (Risperidone) PS ORAL 8 MG; 6 MG, 22-Feb-2006 08:20 AM Page: 1373 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAILY, ORAL Depakote (Valproate Semisodium) C Clonopin (Clonazepam) C Date:08/02/02ISR Number: 3961178-7Report Type:Periodic Company Report #NSADSS2002003734 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Consumer Risperdal (4 Mg Convulsion Tablet) Personality Disorder (Risperidone) PS ORAL 4 MG, 2 IN 1 Purpura DAY(S), ORAL Lithium (Lithium) SS ORAL 300 MG, 3 IN 1 DAY(S), ORAL Prolixin (Fluphenazine Hydrochloride) C Lopid (Gemfibrozil) C Cogentin (Benzatropine Mesilate) C Date:08/02/02ISR Number: 3961180-5Report Type:Periodic Company Report #NSADSS2002003738 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phlebitis Health Risperdal Initial or Prolonged Pulmonary Embolism Professional (Risperidone) PS ORAL 2 MG, 1 IN 1 NIGHT(S), ORAL Clomipramine (Clomipramine) SS ORAL 75 MG, 1 IN 1 NIGHT(S), ORAL Remeron (Mirtazapine) SS ORAL 45 MG, 1 IN 1 NIGHT(S), ORAL Zoloft (Sertraline Hydrochloride) SS ORAL 250 MG, 1 IN 1 DAY(S), ORAL Buspar (Buspirone Hydrochloride) SS ORAL 45, 2 IN DAILY, ORAL Clonazepam (Clonazepam) SS ORAL DAILY, ORAL Date:08/02/02ISR Number: 3961181-7Report Type:Periodic Company Report #NSADSS2002003950 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sleep Apnoea Syndrome Health Risperdal (3 Mg Initial or Prolonged Professional Tablet) (Risperidone) PS ORAL 3 MG, 2 IN 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 1374 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fluphenazine (Fluphenazine) C Date:08/02/02ISR Number: 3961183-0Report Type:Periodic Company Report #NSADSS2002003954 Age:4 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Effect Increased Health Risperdal (Tablet) Initial or Prolonged Tachycardia Professional (Risperidone) PS ORAL 0.25 MG, Company DAILY, ORAL Representative Date:08/02/02ISR Number: 3961185-4Report Type:Periodic Company Report #NSADSS2001028618 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL 0.5, 2 IN DAILY, ORAL Paxil (Paroxetine Hydrochloride) C Date:08/02/02ISR Number: 3961187-8Report Type:Periodic Company Report #NSADSS2001034115 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY(S), ORAL Date:08/02/02ISR Number: 3961189-1Report Type:Periodic Company Report #NSADSS2001036845 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAILY, ORAL Date:08/02/02ISR Number: 3961190-8Report Type:Periodic Company Report #NSADSS2001037538 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Initial or Prolonged Syndrome Professional (Unspecified) Tardive Dyskinesia (Risperidone) PS ORAL 7 MG, DAILY, ORAL Chloral Hydrate C 22-Feb-2006 08:20 AM Page: 1375 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/02ISR Number: 3961192-1Report Type:Periodic Company Report #NSADSS2001037671 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Risperdal (.25 Mg Headache Tablet) (Risperidone) PS ORAL 0.25 MG, 2 IN DAILY, ORAL Celexa (Citalopram Hydrobromide) C Thyroid Medication Nos (Thyroid Prep Unsp) C Menest (Estrogens Conjugated) C Date:08/02/02ISR Number: 3961194-5Report Type:Periodic Company Report #NSADSS2001039027 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Risperdal Initial or Prolonged Hyperprolactinaemia (Unspecified) (Risperidone) PS ORAL ORAL Date:08/02/02ISR Number: 3961196-9Report Type:Periodic Company Report #NSADSS2002000027 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Risperdal (2 Mg Initial or Prolonged Professional Tablet) (Risperidone) PS ORAL 2 MG, 1 IN DAILY, ORAL Date:08/02/02ISR Number: 3961198-2Report Type:Periodic Company Report #NSADSS2002000614 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Risperdal (2 Mg Initial or Prolonged Professional Tablet) Other (Risperidone) PS ORAL 2 MG, 1 IN 1 DAY(S), ORAL Date:08/02/02ISR Number: 3961199-4Report Type:Periodic Company Report #NSADSS2002000760 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal (0.5 Mg Initial or Prolonged Confusional State Tablet) Insomnia (Risperidone) PS ORAL 0.5 MG, 1 IN Salivary Hypersecretion 1 DAY(S), Tremor ORAL Temazepam C Haldol (Haloperidol) C Ativan (Lorazepam) C 22-Feb-2006 08:20 AM Page: 1376 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/02ISR Number: 3961201-XReport Type:Periodic Company Report #NSADSS2002000884 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Risperdal (3 Mg Initial or Prolonged Anxiety Tablet) Depression (Risperidone) PS ORAL 3 MG, 1 IN 1 Pyrexia DAY(S), ORAL; Suicide Attempt 2 MG, 1 IN 1 DAILY, ORAL Date:08/06/02ISR Number: 3958377-7Report Type:Direct Company Report #CTU 173597 Age:96 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Jaundice Cholestatic Risperdal 0.5 Mg PS ORAL 0.5 MG QD Intervention to ORAL Prevent Permanent Impairment/Damage Date:08/06/02ISR Number: 3959154-3Report Type:Expedited (15-DaCompany Report #EMADSS2001005486 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Catatonia Foreign Risperidone Dysphagia Study (Risperidone) PS PATIENT HAD Headache Health PREVIOUSLY Muscle Rigidity Professional RECEIVED Neuroleptic Malignant RISPERIDONE Syndrome FROM Respiratory Failure Topiramate (Capsule) (Topiramate) SS ORAL 3 CAP, DAILY, ORAL Placebo (Placebo) SS ORAL 3 CAP, DAILY, ORAL Lithium (Lithium) SS Lorazepam (Lorazepam) C Chloral Hydrate (Chloral Hydrate) C Diazepam (Diazepam) C Olanzapine (Olanzapine) C Senna (Senna) C Lactulose (Lactulose) C Haloperidol (Haloperidol) C Lithium Carbonate (Lithium Carbonate) C Date:08/06/02ISR Number: 3959339-6Report Type:Expedited (15-DaCompany Report #2002002219 Age:69 YR Gender:Female I/FU:F Outcome PT Hospitalization - Cardiac Enzymes Increased Initial or Prolonged Electrocardiogram Qt Other Prolonged Embolism 22-Feb-2006 08:20 AM Page: 1377 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypokalaemia Report Source Product Role Manufacturer Route Dose Duration Foreign Azithromycin Health (Azithromycin) PS ORAL 250 Professional MG(DAILY), ORAL Risperidone SS ORAL 1 MG (BEDTIME), ORAL Fluvoxamine SS ORAL 100 MG (BEDTIME), ORAL Antidepressants C Ranitidine C Flurazepam C Metoprolol C Date:08/06/02ISR Number: 3959489-4Report Type:Expedited (15-DaCompany Report #EMADSS2002002402 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Risperdal Disorientation Health (Unspecified) Hallucination, Visual Professional (Risperidone) PS ORAL 2 MG, 2 IN 1 Psychomotor Retardation DAY(S), ORAL ; 4 MG, 2 IN 1 DAY(S), ORAL Tercian (Cyamemazine) C Lepticur (Tropatepine Hydrochloride) C Stilnox (Zolpidem) C Date:08/06/02ISR Number: 3959492-4Report Type:Expedited (15-DaCompany Report #APCDSS2002000663 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Risperdal (Tablet) Increased Health (Risperidone) PS ORAL MG, DAILY, Aspartate Professional ORAL Aminotransferase Paroxetine Increased Hydrochloride Blood Creatine Hydrate (Paroxetine Phosphokinase Increased Hydrochloride) SS ORAL MG, DAILY, Blood Lactate ORAL Dehydrogenase Increased Naftopidil Cytomegalovirus Infection (Naftopidil) C Depression Etizolam (Etizolam) C Dizziness Magnesium Oxide Herpes Zoster (Magnesium Oxide) C Laboratory Test Abnormal Pranlukast Psychiatric Symptom (Pranlukast) C Tinnitus Ursodesoxycholic Acid (Ursodeoxycholic Acid) C 22-Feb-2006 08:20 AM Page: 1378 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aciclovir (Aciclovir) C Date:08/06/02ISR Number: 3959641-8Report Type:Expedited (15-DaCompany Report #EMADSS2002004530 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Risperdal Initial or Prolonged Pyrexia Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:08/06/02ISR Number: 3959643-1Report Type:Expedited (15-DaCompany Report #NSADSS2002024678 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Risperdal Initial or Prolonged Delirium Health (Unspecified) Disorientation Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 Drug Interaction DAILY, ORAL Renal Failure Lisinopril (Lisinopril) C Serzone (Nefazodone Hydrochloride) C Lipitor (Atorvastatin) C Date:08/06/02ISR Number: 3959644-3Report Type:Expedited (15-DaCompany Report #EMADSS2002002815 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Risperdal Initial or Prolonged Circulatory Collapse Health (Unspecified) Exophthalmos Professional (Risperidone) PS 1 MG, 2 IN 1 Gait Disturbance DAY(S), UNKNOWN Chlorpromazine (Chlorpromazine) SS Date:08/06/02ISR Number: 3959645-5Report Type:Expedited (15-DaCompany Report #EMADSS2002004539 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Dreams Foreign Risperdal Condition Aggravated Health (Unspecified) Confusional State Professional (Risperidone) PS Drug Withdrawal Syndrome Seroxat (Paroxetine Dyspepsia Hydrochloride) SS Haemorrhage Ovranette (Eugynon) C Hyperhidrosis Lustral (Sertraline Insomnia Hydrochloride) C Polydipsia Hypericum Perforatum Psychotic Disorder (Hypericum Retching Perforatum (Hypericum Perforatum) C Diazepam (Diazepam) C 22-Feb-2006 08:20 AM Page: 1379 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/02ISR Number: 3959740-0Report Type:Expedited (15-DaCompany Report #NSADSS2002024999 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAY(S), ORAL Date:08/07/02ISR Number: 3959841-7Report Type:Expedited (15-DaCompany Report #APCDSS2002000727 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Risperdal (Tablet) Initial or Prolonged Depressed Level Of Health (Risperidone) PS ORAL MG, DAILY, Consciousness Professional ORAL Disseminated Oxypertine Intravascular Coagulation (Oxypertine) SS ORAL ORAL Dyskinesia Imipramine Intentional Overdose Hydrochloride Neuroleptic Malignant (Imipramine Syndrome Hydrochloride) SS ORAL ORAL Pyrexia Mianserin Thrombocytopenia Hydrochloride (Mianserin Hydrochloride) C Date:08/07/02ISR Number: 3960550-9Report Type:Expedited (15-DaCompany Report #NSADSS2002025690 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Risperdal (Tablet) Initial or Prolonged Diabetes Mellitus Professional (Risperidone) PS ORAL 1.75 MG, 1 IN Drooling 1 DAY(S), Joint Stiffness ORAL : 1.5 Muscle Rigidity MG, ORAL Renal Failure Date:08/08/02ISR Number: 3960836-8Report Type:Expedited (15-DaCompany Report #NSADSS2002026045 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Malignant Health Risperdal Professional (Unspecified) (Risperidone) PS Date:08/08/02ISR Number: 3961282-3Report Type:Expedited (15-DaCompany Report #NSADSS2002021103 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Cancer In Situ Foreign Risperdal Hospitalization - Health (Unspecified) Initial or Prolonged Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 DAILY, ORAL Remeron (Mirtazapine) C Dalmane (Flurazepam 22-Feb-2006 08:20 AM Page: 1380 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:08/12/02ISR Number: 3961436-6Report Type:Expedited (15-DaCompany Report #EMADSS2002004670 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ventricular Extrasystoles Foreign Risperdal Ventricular Fibrillation Health (Unspecified) Professional (Risperidone) PS 1 MG DAILY Date:08/12/02ISR Number: 3961437-8Report Type:Expedited (15-DaCompany Report #EMADSS2002002643 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 1.5 MG, 2 IN 1 DAILY, ORAL Sodium Valproate (Valproate Sodium) C Date:08/12/02ISR Number: 3961438-XReport Type:Expedited (15-DaCompany Report #NSADSS200214844 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Serzone (Nefazodone Hydrochloride) C Loxapine (Loxapine) C Date:08/12/02ISR Number: 3961462-7Report Type:Direct Company Report #CTU 173931 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required White Blood Cell Count Risperdal -Janssen PS Janssen ORAL 0.5-2MG/DAY Intervention to Decreased PO Prevent Permanent Multivitamin C Impairment/Damage Regular Tylenol C Date:08/12/02ISR Number: 3961619-5Report Type:Expedited (15-DaCompany Report #NSADSS2002022366 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Tablet)(Risperidone ) PS ORAL SEE IMAGE Remeron (Mirtazapine) C Prozac (Fluoxetine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1381 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/02ISR Number: 3962275-2Report Type:Expedited (15-DaCompany Report #EMADSS2002004738 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Oedema Foreign Risperidone Initial or Prolonged Confusional State Health (Solution) Fall Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 Grand Mal Convulsion DAILY, ORAL Head Injury Remeron Hyponatraemia (Mirtazapine) C Vomiting Xanax (Alprazolam) C Stilnox (Zolpidem) C Concor (Bisoprolol Fumate) C Date:08/13/02ISR Number: 3962828-1Report Type:Expedited (15-DaCompany Report #2002AP01772 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Seroquel PS ORAL 200 MG DAILY Hospitalization - Blood Triglycerides Health PO Initial or Prolonged Increased Professional Seroquel SS ORAL 300 MG DAILY Coma Other PO Condition Aggravated Risperdal SS ORAL 2 MG DAILY PO Dehydration Risperdal SS ORAL 3 MG DAILY PO Depressed Level Of Risperdal SS ORAL 4 MG DAILY PO Consciousness Meilax C Diabetic Ketoacidosis Benzalin C Hyperkalaemia Hypokalaemia Hyponatraemia Insomnia Shock Weight Decreased Date:08/13/02ISR Number: 3963081-5Report Type:Expedited (15-DaCompany Report #NSADSS2002026381 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Risperdal PS ORAL 6 MG, DAILY, Initial or Prolonged Hallucination, Auditory Literature ORAL Hyponatraemia Health Orap(Pimozide) C Insomnia Professional Biperiden And Rhabdomyolysis Preparations(Biperid Water Intoxication en) C Date:08/13/02ISR Number: 3963169-9Report Type:Expedited (15-DaCompany Report #NSADSS2002026256 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS 22-Feb-2006 08:20 AM Page: 1382 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/13/02ISR Number: 3963170-5Report Type:Expedited (15-DaCompany Report #NSADSS2002026638 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:08/14/02ISR Number: 3962149-7Report Type:Expedited (15-DaCompany Report #02-08-0687 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catatonia Foreign Clozapine Tablets PS ORAL 50-350 MG QD Initial or Prolonged Condition Aggravated Literature ORAL Drug Interaction Health Risperidone SS 4-16 MG QD Drug Toxicity Professional Diazepam C Dysphagia Neuroleptic Malignant Syndrome Date:08/14/02ISR Number: 3962287-9Report Type:Direct Company Report #CTU 174041 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Risperidone 2mg PS ORAL 2MG BID ORAL Initial or Prolonged Syndrome Date:08/15/02ISR Number: 3962450-7Report Type:Expedited (15-DaCompany Report #WAES 0208GBR00056 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Vioxx PS Merck & Co., Inc ORAL 7 DAY Initial or Prolonged Hallucination, Visual Risperidone SS ORAL 3 DAY Tachyarrhythmia Atenolol C ORAL Bendroflumethiazide C ORAL Prednisolone C ORAL Fosamax C ORAL Date:08/15/02ISR Number: 3964065-3Report Type:Expedited (15-DaCompany Report #NSADSS2002026976 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 4 MG, DAILY, ORAL Date:08/15/02ISR Number: 3964066-5Report Type:Expedited (15-DaCompany Report #NSADSS2002026966 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1383 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/02ISR Number: 3964069-0Report Type:Expedited (15-DaCompany Report #NSADSS2002026971 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:08/15/02ISR Number: 3964100-2Report Type:Expedited (15-DaCompany Report #EMADSS2002001067 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Risperdal (Solution) Livedo Reticularis Health (Risperidone PS ORAL 6 MG, DAILY, Sedation Professional ORAL Company Theralene Representative (Alimemazine Tartrate) SS ORAL 35 MG, DAILY, ORAL Tercian (Cyamemazine) SS ORAL 125 MG, DAILY, ORAL Lepticur (Tropatepine Hydrochloride) SS ORAL 20 MG, DAILY, ORAL Noctran(Noctran) C Date:08/15/02ISR Number: 3964103-8Report Type:Expedited (15-DaCompany Report #EMADSS2002004792 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Risperdal Initial or Prolonged Hyponatraemia Health (Tablet)(Risperidone Purpura Professional ) PS ORAL 0.5 MG , ORAL Norvasc (Amlodipine Besilate) SS Date:08/15/02ISR Number: 3964104-XReport Type:Expedited (15-DaCompany Report #EMADSS2002004787 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Foreign Risperdal (8mg Initial or Prolonged Distress Syndrome Health Tablet) Required Haemangioma Professional (Risperidone) PS ORAL 8MG, DAILY, Intervention to Pancytopenia ORAL Prevent Permanent Pneumonia Aspiration Depakine Chrono Impairment/Damage Staphylococcal Infection (Ergenyl Chrono) SS ORAL 1 G, DAILY, ORAL Cefacidal (Cefazolin Sodium) SS INTRAVENOUS IV Azantac (Ranitidine Hydrochloride) SS ORAL 300 MG , DAILY, ORAL Noctran (Noctran) C 22-Feb-2006 08:20 AM Page: 1384 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/16/02ISR Number: 3964206-8Report Type:Expedited (15-DaCompany Report #NSADSS2002027117 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL ORAL Date:08/16/02ISR Number: 3964290-1Report Type:Expedited (15-DaCompany Report #NSADSS2002027257 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:08/16/02ISR Number: 3964291-3Report Type:Expedited (15-DaCompany Report #NSADSS2002027260 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:08/19/02ISR Number: 3964786-2Report Type:Expedited (15-DaCompany Report #B0275805A Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Paxil (Formulation Initial or Prolonged Anxiety Unknown) (Paroxetine Suicidal Ideation Hydrochloride) PS ORAL 20 MG/PER DAY/ORAL Risperidone (Formulation Unknown) (Risperidone) SS ORAL 5 MG/TWICE PER DAY/ORAL Date:08/19/02ISR Number: 3964788-6Report Type:Expedited (15-DaCompany Report #D0038831A Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Paxil Tablet Initial or Prolonged Intentional Overdose Health (Paroxetine Subarachnoid Haemorrhage Professional Hydrochloride) PS ORAL SINGLE DOSE/ Suicide Attempt ORAL Risperidone Tablet (Risperidone) SS ORAL SINGLE DOSE/ORAL Date:08/20/02ISR Number: 3964528-0Report Type:Direct Company Report #CTU 174621 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abdominal Distension Risperdale/Risperido Dry Mouth ne 1 Mg Jansen Hypoaesthesia Pharmaceutical Sleep Disorder Products Lp 22-Feb-2006 08:20 AM Page: 1385 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Titusville New PS Jansen Pharmaceutical Products 1 MG EVENING IN A WEEK, 2 TABLETS Date:08/20/02ISR Number: 3965232-5Report Type:Expedited (15-DaCompany Report #NSADSS2002027495 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:08/20/02ISR Number: 3965325-2Report Type:Expedited (15-DaCompany Report #NSADSS2002026381 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Risperdal (Tablet) Initial or Prolonged Convulsion Literature (Risperidone) PS ORAL 6 MG, DAILY, Depressed Level Of Health ORAL Consciousness Professional Orap (Pimozide) C Hallucination, Auditory Biperiden And Hyponatraemia Preparations Insomnia (Biperiden) C Rhabdomyolysis Water Intoxication Date:08/20/02ISR Number: 3965632-3Report Type:Expedited (15-DaCompany Report #EMADSS2001005486 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Ineffective Foreign Risperidone Neuroleptic Malignant Study (Unspecified) Syndrome Health (Risperidone) PS PATIENT HAD Respiratory Failure Professional PREVIOUSLY RECEIVED RISPERIDONE FROM Topiramate (Capsule) (Topiramate) SS ORAL 3 CAP DAILY, ORAL Placebo (Placebo) SS ORAL 3 CAP, DAILY, ORAL Lithium (Lithium) SS Lorazepam (Lorazepam) C Chloral Hydrate (Chloral Hydrate) C Diazepam (Diazepam) C Olanzapine (Olanzapine) C Senna (Senna) C Lactulose (Lactulose) C Haloperidol (Haloperidol) C Lithium Carbonate (Lithium Carbonate) C 22-Feb-2006 08:20 AM Page: 1386 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/02ISR Number: 3965633-5Report Type:Expedited (15-DaCompany Report #EMADSS2002003487 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Foreign Risperdal Infertility Female Health (Unspecified) Pituitary Tumour Benign Professional (Risperidone) PS 2 MG Cipramil (Citalopram) C Date:08/21/02ISR Number: 3964896-XReport Type:Expedited (15-DaCompany Report #NSADSS2002027664 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:08/21/02ISR Number: 3965784-5Report Type:Expedited (15-DaCompany Report #PHFR2002GB02520 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Foreign Ritaline Initial or Prolonged Emotional Distress Health (Methylphenidate Disability Professional Hydrochloride) Other Other Tablet PS ORAL 60 MG MANE + 30 MG TID, ORAL Risperidone (Risperidone) SS ORAL 0.5 G MANE, ORAL Date:08/21/02ISR Number: 3965881-4Report Type:Expedited (15-DaCompany Report #NSADSS2002027572 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Topamax Initial or Prolonged Depressed Level Of Health (Unspecified) Consciousness Professional (Topiramate) PS ORAL ORAL Overdose Risperdal(Unspecifie Suicide Attempt d) (Risperidone) SS ORAL ORAL Date:08/22/02ISR Number: 3964967-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-11994381 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Disorder Cefacidal Inj 1 G PS Apothecon INTRAVENOUS 3 DAY Initial or Prolonged Pancytopenia Risperdal SS ORAL 17 MON Post Procedural Depakine Chrono SS ORAL 17 MON Complication Azantac SS ORAL 3 DAY Respiratory Depression Noctran C Staphylococcal Infection 22-Feb-2006 08:20 AM Page: 1387 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/02ISR Number: 3967145-1Report Type:Expedited (15-DaCompany Report #NSADSS2002021636 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Risperdal Professional (Unspecified) (Risperidone) PS 1 MG IN AM AND 3 MG HS Date:08/23/02ISR Number: 3967160-8Report Type:Expedited (15-DaCompany Report #NSADSS2002021227 Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Risperdal (Tablet) Professional (Risperidone) PS 0.5 MG AM 0.5 MG 4 PM 1 MG HS Exelon (Rivastigmine) C Centrum Silver (Centrum Silver) C Demadex (Torsemide) C Periactin (Cyproheptadine Hydrochloride) C Xanax (Alprazolam) C K-Dur (Potassium Chloride) C Lozol (Indapamide) C Temazepam (Temazepam) C Aspirin (Acetylsalicylic Acid) C Lortab (Vicodin) C Date:08/23/02ISR Number: 3967197-9Report Type:Expedited (15-DaCompany Report #EMADSS2002004910 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anorexia Foreign Risperdal Renal Failure Health (Unspecified) Professional (Risperidone) PS Date:08/23/02ISR Number: 3967615-6Report Type:Expedited (15-DaCompany Report #NSADSS2002028019 Age:94 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:08/26/02ISR Number: 3967418-2Report Type:Expedited (15-DaCompany Report #APCDSS2002000858 Age:20 YR Gender:Male I/FU:I Outcome PT Hospitalization - Delusion Initial or Prolonged Hallucination 22-Feb-2006 08:20 AM Page: 1388 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Movement Disorder Treatment Noncompliance Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS MG, DAILY, Company Amphetamines Representative (Metamphetamine) SS Date:08/26/02ISR Number: 3967793-9Report Type:Expedited (15-DaCompany Report #NSADSS2002028456 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:08/26/02ISR Number: 3967982-3Report Type:Expedited (15-DaCompany Report #02P-056-0198271-00 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Tranxene Initial or Prolonged Headache Health (Clorazepatae Hypothermia Professional Dipotassium) Vomiting (Clorazepate Dipotassium) PS ORAL 10 MG, 1 IN 1 D, PER ORAL Zopiclone SS ORAL 7.5 MG, 1 IN 1 D, PER ORAL Cyamemazine SS ORAL 25 MG, 1 IN 1 D, PER ORAL Aciclovir SS ORAL 200 MG, 4 IN 1 D, PER ORAL Rimexolone SS OPHTHALMIC 1 GTT, 4 IN 1 D, OPTHALMIC Risperidone SS ORAL 20 MG, 1 IN 1 D, ORAL Date:08/27/02ISR Number: 3967602-8Report Type:Direct Company Report #CTU 175191 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Risperdone 2mg Janssen PS Janssen 4MG Q12HR Date:08/27/02ISR Number: 3968166-5Report Type:Expedited (15-DaCompany Report #EMADSS2002005017 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Risperdal Initial or Prolonged Mental Impairment Health (Unspecified) Somnolence Professional (Risperidone) PS Imovane (Zopiclone) SS ORAL ORAL Rivotril (Clonazepam) SS ORAL ORAL Tercian (Cyamemazine) C 22-Feb-2006 08:20 AM Page: 1389 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Flecaine (Flecaindie Acetate) C Tiapridal (Tiapride) C Date:08/27/02ISR Number: 3968244-0Report Type:Expedited (15-DaCompany Report #02P-151-0198431-00 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Creatine Foreign Depakine (Depakene) Intervention to Phosphokinase Increased Health (Sodium Valproate/ Prevent Permanent Professional Valproic Acid) Impairment/Damage (Sodium Valproate/Valproic PS ORAL 1500 MG, 1 IN 1 D, ORAL Risperidone SS ORAL 4 MG, 1 IN 1D, ORAL Date:08/27/02ISR Number: 3968291-9Report Type:Expedited (15-DaCompany Report #B0276545A Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Calcium Decreased Foreign Paxil (Formulation Initial or Prolonged Bradycardia Unknown) (Paroxetine Extrapyramidal Disorder Hydrochloride) PS ORAL 20 MG / PER Fall DAY / ORAL Head Injury Clorazepate Hypochloraemia Dipotassium Hypoglycaemia (Formulation Hypomagnesaemia Unknown) Hyponatraemia (Clorazepate SS ORAL 30 MG / PER Hypophosphataemia DAY / ORAL Hypothermia Risperidone Leukopenia (Formulation Loss Of Consciousness Unknown) Somnolence (Risperidone) SS ORAL 1 MG / PER Subdural Haematoma DAY / ORAL Supraventricular Tachycardia Date:08/27/02ISR Number: 3969192-2Report Type:Expedited (15-DaCompany Report #A0377880A Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Attention Health Eskalith Tablet Initial or Prolonged Drug Level Increased Professional -Controlled Release Required Dyspepsia (Lithium Carbonate) PS ORAL UNK / SEE Intervention to Muscle Rigidity DOSAGE TEXT / Prevent Permanent Overdose ORAL Impairment/Damage Psychomotor Hyperactivity Buspirone Restlessness Hydrochloride Somnolence (Formulation Speech Disorder Unknown) Buspirone Staring Hydrochloride) SS ORAL ORAL Vomiting Olanzapine (Formulation Unknown)Olanzapine) SS ORAL ORAL Risperidone (Formulation 22-Feb-2006 08:20 AM Page: 1390 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unknown)Risperidone) SS ORAL ORAL Benztropine Mesylate (Formulation Unknown)(Benztropine Mesylate) SS ORAL ORAL Thyroxine Sodium (Formulation Unknown) Levothyroxine Sodium) SS ORAL ORAL Date:08/27/02ISR Number: 3969237-XReport Type:Expedited (15-DaCompany Report #NSADSS2002028667 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Health Risperdal (Tablet) Initial or Prolonged Deficit/Hyperactivity Professional (Risperidone) PS ORAL 0.5 MG, ORAL Disorder Adderall (Obetrol) C Condition Aggravated Insulin (Insulin) C Diabetes Mellitus Inadequate Control Diabetic Coma Date:08/28/02ISR Number: 3967026-3Report Type:Expedited (15-DaCompany Report #B0277515A Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Zovirax PS Glaxo Wellcome ORAL 200MG Four Initial or Prolonged Headache times per day Hypothermia Imovane SS ORAL 7.5MG per day Vomiting Tercian SS ORAL 25MG per day Tranxene SS ORAL 10MG Per day Vexol SS OPHTHALMIC 1DROP Four times per day Risperdal SS ORAL 2MG per day Date:08/28/02ISR Number: 3969064-3Report Type:Expedited (15-DaCompany Report #NSADSS2002016592 Age:6 MON Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Maternal Drugs Affecting Health Risperdal Foetus Professional (Risperidone) PS EXPOSURE IN Myotonia Congenita Company UTERO Representative Date:08/30/02ISR Number: 3969367-2Report Type:Expedited (15-DaCompany Report #NSADSS2002029547 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, 1 IN 1 NIGHT(S), ORAL 22-Feb-2006 08:20 AM Page: 1391 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/02ISR Number: 3969420-3Report Type:Expedited (15-DaCompany Report #2002051969 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Neurontin Initial or Prolonged Phosphokinase Increased Professional (Gabapentin) PS ORAL 400 MG (BID), Other ORAL Risperidone SS ORAL 0.5 MG (BID), ORAL Topiramate C Salbutamol C Pseudoephedrine Hydrochloride C Paracetamol C Topiramate C Date:08/30/02ISR Number: 3970060-0Report Type:Expedited (15-DaCompany Report #NSADSS2002029182 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Risperdal (1 Mg Pulmonary Disease Professional Tablet) Diabetic Complication (Risperidone) PS ORAL 1 MG, ORAL Date:09/03/02ISR Number: 3971629-XReport Type:Expedited (15-DaCompany Report #EMADSS2002005094 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glaucoma Foreign Risperdal PS Health Professional Date:09/03/02ISR Number: 3971630-6Report Type:Expedited (15-DaCompany Report #EMADSS2002005088 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Temporal Arteritis Foreign Risperdal PS Health Professional Date:09/03/02ISR Number: 3971633-1Report Type:Expedited (15-DaCompany Report #EMADSS2002004248 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Haldol PS Initial or Prolonged Pain Consumer Risperdal (Tablet) Other Parkinson'S Disease (Risperidone) SS ORAL 6 MG DAILY Restlessness ORAL Zoloft (Sertraline Hydrochloride) C Date:09/03/02ISR Number: 3971669-0Report Type:Expedited (15-DaCompany Report #EMADSS2002005085 Age:46 YR Gender:Male I/FU:I Outcome PT Hospitalization - Cough Initial or Prolonged Neutropenia 22-Feb-2006 08:20 AM Page: 1392 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pyrexia Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Risperidone) PS ORAL SEE IMAGE Professional Truxal (Chlorprothixene Hydrochloride) SS ORAL 30 MG DAILY ORAL Cedur (Bezafibrate) C Heparin (Heparin) C Date:09/04/02ISR Number: 3970385-9Report Type:Direct Company Report #CTU 175643 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Aspiration Risperidone 3 Mg PS 1/2MG HS Intervention to Coma Prevent Permanent Haematemesis Impairment/Damage Neuroleptic Malignant Syndrome Respiratory Failure Sputum Culture Positive Vomiting Date:09/04/02ISR Number: 3971538-6Report Type:Expedited (15-DaCompany Report #NSADSS2001039330 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Topamax (Topiramate) PS ORAL ORAL Drug Toxicity Professional Risperdal (2 Mg Myocardial Infarction Tablet) Risperidone) SS ORAL 2 MG, 2 IN DAILY, ORAL Citalopram SS Propoxyphene (Dextropropoxyphene) SS Quetiapine (Quetiapine) SS Triazolam (Triazolam) SS Diphenhydramine C Acetaminophen (Paracetamol) C Bupropion (Amfebutamone) C Ultram (50 Mg Tablet) (Tramadol Hydrochloride) C Nizoral (Ketoconazole) C Seroquel C Remeron (Mirtazapine) C Multivitamins C Relafen (Nabumetone) C Skelaxin (Metaxalone) C Guaibid (Guaifenesin) C 22-Feb-2006 08:20 AM Page: 1393 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Advair (Fluticasone) C Albuterol (Salbutamol) C Desonide C Depakote (Valproate Semisodium) C Prevacid (Lansoprazole) C Date:09/05/02ISR Number: 3970638-4Report Type:Expedited (15-DaCompany Report #B0277978A Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Inguinal Hernia Consumer Combivir PS Glaxo Wellcome ORAL 2TAB Per day Initial or Prolonged Risperdal SS ORAL Viramune SS ORAL 200MG Per day Date:09/05/02ISR Number: 3971182-0Report Type:Direct Company Report #CTU 175746 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Risperdone 1mg Diarrhoea Tablets PS ORAL 1 1/2 TAB PO Rash QHS Viral Infection Prochlorperazine Vomiting 15mg Tablets SS ORAL 2 TAB PO Q 8H Carbamazepine Xr C Citalopram C Clonidine C Hydroxyzine C Ibuprofen C Oxazepam C Ranitidine C Date:09/06/02ISR Number: 3972125-6Report Type:Expedited (15-DaCompany Report #APCDSS2002000727 Age:76 YR Gender:Male I/FU:F Outcome PT Life-Threatening Acidosis Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Required Anorexia Intervention to Aspartate Prevent Permanent Aminotransferase Impairment/Damage Increased Aspiration Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Blood Pressure Decreased Body Temperature Decreased Cerebral Infarction Convulsion 22-Feb-2006 08:20 AM Page: 1394 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dehydration Depressed Level Of Consciousness Report Source Product Role Manufacturer Route Dose Duration Disseminated Foreign Risperdal (Tablet) Intravascular Coagulation Health (Risperidone) PS ORAL MG, DAILY, Dyskinesia Professional ORAL Gait Disturbance Sulpiride Hyperpyrexia (Sulpiride) SS ORAL MG, DAILY, Infection ORAL Insomnia Oxypertine Neuroleptic Malignant (Oxypertine) SS ORAL MG, DAILY, Syndrome ORAL Overdose Clonidine Parkinson'S Disease Hydrochloride Pleural Effusion (Clonidine Pneumonia Hydrochloride) SS ORAL MG, DAILY, Productive Cough ORAL Shock Mianserin Status Epilepticus Hydrochloride Thrombocytopenia (Mianserin Hydrochloride) SS ORAL MG, DAILY, ORAL Imipramine Hydrochloride (Imipramine Hydrochloride) SS ORAL MG, DAILY, ORAL Zolpidem Tartrate (Zolpidem Tartrate) C Tamsulosin Hydrochloride (Tamsulosin Hydrochloride) C Magnesium Oxide (Magnesium Oxide) C Sennoside (Sennosides) C Date:09/06/02ISR Number: 3972132-3Report Type:Expedited (15-DaCompany Report #EMADSS2002005202 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Inguinal Hernia Foreign Risperdal (Tablet) Initial or Prolonged Health (Risperidone) PS ORAL ORAL Required Professional Viramune Intervention to (Nevirapine) SS ORAL 200 MG, ORAL Prevent Permanent Combivir (Zidovudine Impairment/Damage W/Lamivudine) SS ORAL ORAL Date:09/06/02ISR Number: 3972313-9Report Type:Expedited (15-DaCompany Report #EMADSS2002005118 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Foreign Risperdal (2 Mg Condition Aggravated Health Tablet) Extrapyramidal Disorder Professional (Risperidone) PS ORAL 2 MG, DAILY, Joint Stiffness ORAL Muscle Rigidity Dipiperon Neoplasm (Unspecified) 22-Feb-2006 08:20 AM Page: 1395 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Pipamperone) SS 60 MG, DAILY, Eunerpan (Melperone Hydrochloride) SS ORAL 50 MG, DAILY, ORAL Zyprexa (Olanzapine) SS ORAL 10 MG, DAILY, ORAL Date:09/06/02ISR Number: 3972314-0Report Type:Expedited (15-DaCompany Report #EMADSS2002005171 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Risperdal (Tablet) Decreased Health (Risperidone) PS ORAL 2 MG, 2 IN 1 Professional DAY(S), ORAL Benzodiazepines (Benzodiazepine Derivatives) C Sortis (Atorvastatin Calcium) C Date:09/06/02ISR Number: 3972315-2Report Type:Expedited (15-DaCompany Report #APCDSS2002000696 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Conjunctival Oedema Foreign Risperidone (Tablet) Initial or Prolonged Eye Disorder Health (Risperidone) PS ORAL 0.5 MG, 1 IN Other Glaucoma Professional 1 DAILY, ORAL Required Visual Disturbance Promethazine C Intervention to Chuan Xiling C Prevent Permanent Xi Demei C Impairment/Damage Date:09/06/02ISR Number: 3972531-XReport Type:Direct Company Report #USP 55076 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Risperdal PS Janssen Date:09/06/02ISR Number: 3972698-3Report Type:Direct Company Report #CTU 175852 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Agitation Risperdal 1mg Tabs PS ORAL 1MG AM 2 MG Intervention to Athetosis PM ORAL Prevent Permanent Chorea Celexa 10mg Tab Then Impairment/Damage Eyelid Function Disorder 20mg Tab SS ORAL 20MG AM ORAL Flashback Suicidal Ideation Date:09/09/02ISR Number: 3973461-XReport Type:Direct Company Report #USP 055207 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Estradiol PS Mylan Risperdal (Risperidone) SS Janssen 22-Feb-2006 08:20 AM Page: 1396 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/02ISR Number: 3973855-2Report Type:Expedited (15-DaCompany Report #NSADSS2002030323 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Health Risperdal Deterioration Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:09/09/02ISR Number: 3973940-5Report Type:Expedited (15-DaCompany Report #APCDSS2002000968 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Foreign Risperdal Eye Pain Health (Unspecified) Professional (Risperidone) PS ORAL MG, DAILY, ORAL 4 MON Date:09/09/02ISR Number: 3974237-XReport Type:Expedited (15-DaCompany Report #NSADSS2002015082 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Risperdal Initial or Prolonged Amenorrhoea (Unspecified) Depression (Risperidone) PS ORAL ORAL Dyspepsia Zyprexa (Olanzapine) C Fall Paxil (Paroxetine Haemoglobin Decreased Hydrochloride) C Insomnia Paranoia Polycystic Ovaries Proteus Infection Sexual Dysfunction Weight Increased Date:09/10/02ISR Number: 3973850-3Report Type:Expedited (15-DaCompany Report #B0277935A Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Respiratory Foreign Cephazolin Sodium Initial or Prolonged Distress Syndrome Injection (Cefazolin Lung Disorder Sodium) PS INTRAVENOUS INTRAVENOUS Pancytopenia Ranitidine Staphylococcal Infection Hydrochloride Tablet (Ranitidine Hydrochloride) SS ORAL 300 MG/ PER DAY/ ORAL Risperidone (Formulation Unknown) (Risperidone) SS ORAL ORAL Depakine Chrono Tablet-Extended Release (Depakine Chrono) SS ORAL ORAL Noctran C 22-Feb-2006 08:20 AM Page: 1397 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/11/02ISR Number: 3974271-XReport Type:Expedited (15-DaCompany Report #APCDSS2002000975 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Risperdal Initial or Prolonged Dyspnoea Health (Unspecified) Other Malaise Professional (Risperidone) PS DAILY 1 YR Flupenthixol (Flupentixol Decanoate) C Date:09/11/02ISR Number: 3974272-1Report Type:Expedited (15-DaCompany Report #APCDSS2002000988 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Risperdal (Tablet) Initial or Prolonged Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Flunitrazepam (Flunitrazepam) C Quazepam (Quazepam) C Losartan Potassium (Losartan Potassium) C Carvedilol (Carvedilol) C Date:09/11/02ISR Number: 3974273-3Report Type:Expedited (15-DaCompany Report #EMADSS2002005277 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Foreign Risperdal (Tablet) Initial or Prolonged Oedema Peripheral Health (Risperidone) PS ORAL 1 MG, 2 IN 1 Other Professional DAY(S), ORAL Neurocil (Levomepromazine Maleate) C Date:09/11/02ISR Number: 3974274-5Report Type:Expedited (15-DaCompany Report #EMADSS2002005262 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Missed Foreign Risperdal (6 Mg Initial or Prolonged Complications Of Maternal Health Tablet) Required Exposure To Therapeutic Professional (Risperidone) PS ORAL 6 MG, DAILY, Intervention to Drugs ORAL Prevent Permanent Haemoglobin Decreased Impairment/Damage Maternal Drugs Affecting Foetus Oedema Peripheral Pregnancy Date:09/11/02ISR Number: 3974275-7Report Type:Expedited (15-DaCompany Report #EMADSS2002005243 Age:67 YR Gender:Female I/FU:I Outcome PT Death Acute Abdomen Hospitalization - Lung Disorder Initial or Prolonged Neutropenia 22-Feb-2006 08:20 AM Page: 1398 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sepsis Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal (1 Mg Health Tablet) Professional (Risperidone) PS ORAL 2 MG, DAILY, ORAL Nozinan (Levomepromazine) SS ORAL 45 DROPS, DAILY, ORAL Hept-A-Myl (Heptaminol Hydrochloride) SS ORAL 80 DROPS, DAILY, ORAL Seresta (Oxazepam) SS ORAL 30 MG, DAILY, ORAL Deroxat (Paroxetine Hydrochloride) SS ORAL 60 MG, DAILY, ORAL Lepticur (Tropatepine Hydrochloride) C Date:09/11/02ISR Number: 3974607-XReport Type:Expedited (15-DaCompany Report #NSADSS2002030863 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (3 Mg Health Tablet) Professional (Risperidone) PS ORAL 3 MG, 1 IN 1 DAY(S), ORAL Paxil (Paroxetine Hydrochloride) C Date:09/12/02ISR Number: 3975151-6Report Type:Direct Company Report #CTU 176300 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dyskinesia Risperdol 0.25mg Grimacing /Janssen PS Janssen ORAL 0.25MG PO BID Jaw Disorder Nortriptyline C Claritin Lortabs C Flunase Mdi C Date:09/12/02ISR Number: 3975281-9Report Type:Expedited (15-DaCompany Report #APCDSS2002000634 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Foreign Haladol Obesity Health (Unspecified) Polydipsia Professional Haloperidol) PS ORAL MG, DAILY, Thirst ORAL Tonic Convulsion Risperdal (Tablet) (Risperidone) SS ORAL MG, DAILY, ORAL Levomepromazine Maleate (Levopromazine 22-Feb-2006 08:20 AM Page: 1399 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maleate) SS ORAL NG, DAILY, ORAL Promethazine Hydrochloride (Promethaizine Hydrochloride) SS Biperiden Hydrochloride(Biperi den Hydrochloride) C Flunitrazepam (Flunitrazepam) C Sennosides(Sennoside s) C Date:09/12/02ISR Number: 3975337-0Report Type:Expedited (15-DaCompany Report #EMADSS2002005285 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autism Foreign Risperidone (Tablet) Initial or Prolonged Catatonia Health (Risperidone) PS ORAL 5 MG, 2 IN 1 Condition Aggravated Professional DAY(S), ORAL Drug Ineffective Tiapridex (Tiapride Extrapyramidal Disorder Hydrochloride) C Medication Error Akatinol (Memantine Oral Intake Reduced Hydrochloride) C Stupor Tavor (Lorazepam) C Date:09/12/02ISR Number: 3975339-4Report Type:Expedited (15-DaCompany Report #EMADSS2002005250 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Psychotic Disorder Foreign Risperdal(Unspecifie Pulmonary Embolism Health d) (Risperidone) PS 2 TO 4 MG Professional Perazine (Perazine) C Tavor (Lorazepam) C Date:09/13/02ISR Number: 3975639-8Report Type:Direct Company Report #CTU 176358 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Triglycerides Olanzapine 10 Mg PS ORAL 1 TAB ORAL Initial or Prolonged Increased Risperidone 4 Mg SS ORAL 2 TABS ORAL Diabetes Mellitus Drug Effect Decreased Pancreatitis Date:09/13/02ISR Number: 3975975-5Report Type:Expedited (15-DaCompany Report #NSADSS2002031114 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 24 HOUR(S), ORAL 22-Feb-2006 08:20 AM Page: 1400 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/13/02ISR Number: 3975979-2Report Type:Expedited (15-DaCompany Report #NSADSS2002031108 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:09/13/02ISR Number: 3975982-2Report Type:Expedited (15-DaCompany Report #NSADSS2002031514 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Risperdal (0.5 Mg Congestive Health Tablet) Professional (Risperidone) PS ORAL ORAL Date:09/13/02ISR Number: 3976035-XReport Type:Expedited (15-DaCompany Report #EMADSS2002003705 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Neuropathy Peripheral Foreign Risperidone Other Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY(S), ORAL Citalopram (Citalopram) C Valproate Sodium (Valproate Sodium) C Venlafaxine (Venlafaxine) C Date:09/13/02ISR Number: 3976038-5Report Type:Expedited (15-DaCompany Report #NSADSS2002024678 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Prerenal Failure Foreign Risperdal Initial or Prolonged Confusional State Health (Unspecified0 Delirium Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 Disorientation DAILY, ORAL Drug Interaction Lisinopril Oral Intake Reduced (Lisinopril) C Serzone (Nefazodone Hydrochloride) C Lipitor (Atorvastatin) C Date:09/13/02ISR Number: 3976147-0Report Type:Expedited (15-DaCompany Report #NSADSS2002030862 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Risperdal (0.5 Mg Initial or Prolonged Arteriovenous Tablet) Required Malformation (Risperidone) PS ORAL 0.5 MG, 2 IN Intervention to Hallucinations, Mixed DAILY, ORAL Prevent Permanent Migraine Klonopin Impairment/Damage Petit Mal Epilepsy (Clonazepam) C Suicidal Ideation Ativan (Lorazepam) C Geodon C 22-Feb-2006 08:20 AM Page: 1401 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Celexa (Citalopram Hydrobromide) C Date:09/16/02ISR Number: 3975915-9Report Type:Expedited (15-DaCompany Report #FLUV00202001320 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Luvox (Fluvoxamine Electrocardiogram Qt Professional Maleate) PS ORAL 25 MG QD PO, Corrected Interval 25 MG BID PO, Prolonged 75 MG DAILY Electrocardiogram Qt PO, 75 MG BID Prolonged PO Geodon (Ziprasidone Hcl) SS ORAL 40 MG BID PO, 40 MG QD PO Risperdal (Risperdone) SS 3 MG BID Klonopin (Clonazepam) C Colace (Docusate Sodium) C Ditropan (Oxybutynin) C Cogentin (Benzatropine Mesilate) C Depakote (Valproate Semisodium) C Date:09/16/02ISR Number: 3976624-2Report Type:Expedited (15-DaCompany Report #EMADSS2002005362 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apraxia Foreign Reminyl (Tablet) Initial or Prolonged Brain Scan Abnormal Health (Galantamine) PS ORAL 8 MG, DAILY, Fall Professional ORAL Gait Disturbance Risperdal (1 Mg Hypertonia Tablet) Polyneuropathy (Risperidone) SS ORAL 0.5 MG, DAILY, ORAL Neurontin (Gabapentin) SS ORAL 1000 MG, DAILY, ORAL Colchimax (Colchimax) SS ORAL 1 CAP, DAILY, ORAL Seropram (Citalopram Hydrobromide) SS ORAL 20 MG, DAILY; ORAL Bi-Tildiem (Diltiazem Hydrochloride) SS ORAL 180 MG, DAILY; ORAL Nitriderm Tts (Glyceryl Trinitrate) C Hept-A-Myl (Heptaminol 22-Feb-2006 08:20 AM Page: 1402 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Temesta (Lorazepam) C Imovan (Zopiclone) C Dafalgan (Paracetamol) C Kardegic (Acetylsalicylate Lysine) C Date:09/16/02ISR Number: 3976654-0Report Type:Expedited (15-DaCompany Report #EMADS2002005362 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apraxia Foreign Risperdal (1 Mg Initial or Prolonged Areflexia Health Tablet) Fall Professional (Risperidone) PS ORAL 0.5MG, DAILY, Gait Disturbance ORAL Hypertonia Reminyl (Tablet) Hyporeflexia (Galantamine) SS ORAL 8 MG, DAILY, Pain In Extremity ORAL Polyneuropathy Neurontin (Gabapentin) SS ORAL 1000 MG, DAILY, ORAL Colchimax (Colchimax) SS ORAL 1 CAP, DAILY, ORAL Seropram (Citalopram Hydrobromide) SS ORAL 20 MG, DAILY, ORAL Bi-Tildiem (Diltiazem Hydrochloride) SS ORAL 180 MG, DAILY, ORAL Nitriderm Tts (Glyceryl Trinitrate) C Hept-A-Myl (Heptaminol Hydrochloride) C Temesta (Lorazepam) C Imovane (Zopiclone) C Dafalgan (Paracetamol) C Kardegic (Acetylsalicylate Lysine) C Date:09/16/02ISR Number: 3977000-9Report Type:Direct Company Report #CTU 176483 Age:59 YR Gender:Male I/FU:I Outcome PT Life-Threatening Aggression Other Agitation Back Pain Confusional State Dizziness Postural Dyspnoea Headache Heart Rate Increased Insomnia 22-Feb-2006 08:20 AM Page: 1403 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychomotor Hyperactivity Tremor Report Source Product Role Manufacturer Route Dose Duration Risperdal 2mg PS ORAL 1 -TWICE ONLY TOOK 2 ORAL Date:09/17/02ISR Number: 3978492-1Report Type:Expedited (15-DaCompany Report #APCDSS2002001031 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apallic Syndrome Foreign Risperdal Hospitalization - Cardio-Respiratory Arrest Health (Unspecified) Initial or Prolonged Hypoxia Professional (Risperidone) PS ORAL MG, DAILY, ORAL Vegetamin B (Vegetamin B(R)) SS ORAL 1 TABLET, 1 IN 1 DAILY, ORAL Fluvoxamine Maleate (Fluvoxamine Maleate) SS ORAL MG, DAILY, ORAL Ranitidine Hydrochloride (Ranitidine Hydrochloride) C Zopiclone (Zopiclone) C Flunitrazepam (Flunitrazepam) C Triazolam (Triazolam) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Brotizolam (Brotizolam) C Date:09/17/02ISR Number: 3978494-5Report Type:Expedited (15-DaCompany Report #APCDSS2002000727 Age:76 YR Gender:Male I/FU:F Outcome PT Death Alanine Aminotransferase Life-Threatening Increased Hospitalization - Anorexia Initial or Prolonged Aspartate Required Aminotransferase Intervention to Increased Prevent Permanent Aspiration Impairment/Damage Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Blood Pressure Systolic Decreased 22-Feb-2006 08:20 AM Page: 1404 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cerebral Infarction Convulsion Dehydration Report Source Product Role Manufacturer Route Dose Duration Disseminated Foreign Risperdal (Tablet) Intravascular Coagulation Health (Risperidone) PS ORAL MG, DAILY, Dyskinesia Professional ORAL Gait Disturbance Sulpiride Neuroleptic Malignant (Sulpiride) SS ORAL MG, DAILY, Syndrome ORAL Overdose Oxypertine Parkinson'S Disease (Oxypertine) SS ORAL MG, DAILY, Pleural Effusion ORAL Pneumonia Clonidine Productive Cough Hydrochloride Pyrexia (Clonidine Respiratory Failure Hydrochloride) SS ORAL MG, DAILY, Shock ORAL Viral Infection Mianserin Hydrochloride(Mianse rin Hydrochloride) SS ORAL MG, DAILY, ORAL Imipramine Hydrochloride (Imipramine Hydrochloride) SS ORAL MG, DAILY, ORAL Zolpidem Tartrate(Zolpidem Tartrate) C Tamsulosin Hydrochloride(Tamsul osin Hydrochloride) C Magnesium Oxide(Magnesium Oxide) C Sennoside(Sennosides ) C Date:09/17/02ISR Number: 3978496-9Report Type:Expedited (15-DaCompany Report #APCDSS2002000975 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiomyopathy Foreign Risperdal Initial or Prolonged Myocarditis Health (Unspecified) Other Professional (Risperidone) PS MG, DAILY 1 YR Flupenthixol (Flupentixol Decanoate) C Date:09/17/02ISR Number: 3978562-8Report Type:Expedited (15-DaCompany Report #FR9123624JUL2002 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypokalaemia Health Seresta (Oxazepam, Initial or Prolonged Hyponatraemia Professional Tablet) PS ORAL 50 MG 1X PER Other Status Epilepticus Other 1 DAY ORAL 30 DAY Deroxat (Paroxetine Hydrochloride, , 0) SS ORAL 20 MG 1X PER 1 DAY ORAL 30 DAY 22-Feb-2006 08:20 AM Page: 1405 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Parkinane Lp (Trihexyphenidyl, Capsule, Sustained Release, 0) SS ORAL 5 MG 1X PER 2 DAY ORAL STARTED BEFORE 1999 Risperdal (Risperidone, , 0) SS ORAL 2 MG 1X PER 1 DAY ORAL 11 DAY Date:09/17/02ISR Number: 3980346-1Report Type:Expedited (15-DaCompany Report #EMADSS2002005356 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothyroidism Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Date:09/18/02ISR Number: 3977574-8Report Type:Direct Company Report #CTU 176812 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Risperdal 2mg - Intervention to Janssen PS Janssen ORAL 2MG PO QD Prevent Permanent [ONE DOSE Impairment/Damage ONLY] Date:09/19/02ISR Number: 3977774-7Report Type:Expedited (15-DaCompany Report #FR9164404SEP2002 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchial Obstruction Health Seresta (Oxazepam, Faecaloma Professional Tablet, 0) PS ORAL 10 MG 3X PER Febrile Neutropenia Other 1 DAY ORAL 708 DAY Hypoxia Deroxat (Paroxetine Intestinal Obstruction Hydrochloride, , 0) SS ORAL 20 MG 3X PER Pneumonia 1 DAY ORAL 709 DAY Sepsis Hept-A-Myl (Heptaminol Hydrochloride, , 0) SS ORAL 40 DOSE 2X PER 1 DAY ORAL 708 DAY Nozinan (Levomepromazine, ,0) SS ORAL 15 DOSE 3X PER 1 DAY ORAL 708 DAY Risperdal (Risperidone , , 0) SS ORAL 1 MG 2X PER 1 DAY ORAL 708 DAY Lepticur (Tropatepine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1406 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/19/02ISR Number: 3977807-8Report Type:Expedited (15-DaCompany Report #EMADSS2002005036 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Risperdal Initial or Prolonged Cholestasis Health (Risperidone) PS ORAL 1 MG, 3 IN 1 Professional DAILY, ORAL Melperone (Melperone) C Voltarol (Diclofenac Sodium) C Atosil (Isopromethazine Hydrochloride) C Unat Cor (Torsemide) C Ginko (Ginkgo Tree Leaves Extract) C Date:09/19/02ISR Number: 3977853-4Report Type:Expedited (15-DaCompany Report #FR9123624JUL2002 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypokalaemia Foreign Seresta (Oxazepam, Initial or Prolonged Hyponatraemia Health Tablet) PS ORAL 50 MG 1X PER Other Status Epilepticus Professional 1 DAY ORAL 30 DAY Other Deroxat (Paroxetine Hydrochloride, ,0) SS ORAL 20 MG 1X PER 1 DAY ORAL 30 DAY Parkinane Lp (Trihexyphenidyl, Capsule, Sustained Release, 0) SS ORAL 5 MG 1X PER 2 DAY ORAL Risperdal (Risperidone, ,0) SS ORAL 2 MG 1X PER 1 DAY ORAL 11 DAY Date:09/19/02ISR Number: 3978235-1Report Type:Expedited (15-DaCompany Report #APCDSS2002001015 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal (Tablet) Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Date:09/19/02ISR Number: 3978236-3Report Type:Expedited (15-DaCompany Report #EMADSS2002005393 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemorrhage Foreign Risperdal (2 Mg Initial or Prolonged Thrombocytopenia Health Tablet) Professional (Risperidone) PS ORAL 2 MG, DAILY, ORAL Solian (Amisulpride) C 22-Feb-2006 08:20 AM Page: 1407 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/19/02ISR Number: 3978237-5Report Type:Expedited (15-DaCompany Report #EMADSS2002005357 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothyroidism Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Date:09/19/02ISR Number: 3978270-3Report Type:Expedited (15-DaCompany Report #B0279110A Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Crepitations Foreign Paxil Tablets Hospitalization - Intestinal Obstruction (Paroxetine Initial or Prolonged Lung Disorder Hydrochloride) PS OPHTHALMIC 20 MG THREE Neutropenia TIMES PER DAY Pulmonary Congestion / ORAL Sepsis Methotrimeprazine Septic Shock Solution (Methotrimeprazine) SS ORAL 15 UNIT THREE TIMES PER DAY / ORAL Heptaminol Hydrochloride Solution (Heptaminol Hydrochloride) SS ORAL 40 UNIT TWICE PER DAY / ORAL Oxazepam Tablet (Oxazepam) SS ORAL 1 UNIT TWICE PER DAY / ORAL Risperidone Tablet (Risperidone) SS ORAL 1 UNIT TWICE PER DAY / ORAL Tropatepine Hydrochloride C Date:09/19/02ISR Number: 3978273-9Report Type:Expedited (15-DaCompany Report #EMADSS2002003705 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Neuropathy Peripheral Foreign Risperidone Other Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY (S), ORAL Citalopram (Citalopram) C Valproate Sodium (Valproate Sodium) C Venlafaxine (Venlafaxine) C 22-Feb-2006 08:20 AM Page: 1408 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/02ISR Number: 3979396-0Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Haldol(Tablet)(Halop Initial or Prolonged Blood Creatine Health eridol) PS ORAL MG, DAILY, Phosphokinase Increased Professional ORAL;SEE Blood Pressure Increased IMAGE Delusion Risperdal (Tablet) Diabetes Mellitus (Risperidone) SS ORAL MG, DAILY, Hallucination AORAL Hypoventilation Hydroxyzine Pamoate C Insomnia Estazolam Respiratory Distress (Estazolam) C Schizophrenia Zopiclone (Zopiclone C Biperiden Hydrochloride(Biperi den Hydrochloride) C Date:09/23/02ISR Number: 3979492-8Report Type:Expedited (15-DaCompany Report #APCDSS2002000727 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Risperdal (Tablet) Life-Threatening Increased Health (Risperidone) PS ORAL MG, DAILY, Hospitalization - Anorexia Professional ORAL Initial or Prolonged Aspartate Sulpiride Required Aminotransferase (Sulpiride) SS ORAL MG, DAILY, Intervention to Increased ORAL Prevent Permanent Blood Alkaline Oxypertine Impairment/Damage Phosphatase Increased (Oxypertine) SS ORAL MG, DAILY, Blood Bilirubin Increased ORAL Blood Creatine Clonidine Phosphokinase Increased Hydrochloride Blood Lactate (Clonidine Dehydrogenase Increased Hydrochloride) SS ORAL MG, DAILY; Blood Pressure Decreased ORAL Cardiac Arrest Mianserin Convulsion Hydrochloride Depressed Level Of (Mianserin Consciousness Hydrochloride) SS ORAL MG, DAILY, Disseminated ORAL Intravascular Coagulation Imipramine Dyskinesia Hydrochloride Gait Disturbance (Imipramine Gamma-Glutamyltransferase Hydrochloride) SS ORAL MG, DAILY; Abnormal ORAL Infection Zolpidem Tartrate Insomnia (Zolpidem Tartrate) C Overdose Tamsulosin Pleural Effusion Hydrochloride Pneumonia (Tamsulosin Pyrexia Hydrochloride) C Shock Magnesium Oxide Status Epilepticus (Magnesium Oxide) C Thrombocytopenia Sennoside (Sennosides) C 22-Feb-2006 08:20 AM Page: 1409 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/02ISR Number: 3979497-7Report Type:Expedited (15-DaCompany Report #2002056983 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apraxia Foreign Neurontin Initial or Prolonged Cerebral Atrophy Health (Gabapentin) PS ORAL UNKNOWN, ORAL Other Fall Professional Galantamine SS ORAL 8 MG (4 MG, Gait Disturbance TWICE DAILY), Hypertonia ORAL Lacunar Infarction Colchimax SS ORAL UNKNOWN Pain In Extremity (DAILY), ORAL Polyneuropathy Citalopram Hydrobromide SS ORAL 20 MG (DAILY), ORAL Risperidone SS ORAL 0.5 MG (DAILY), ORAL Diltiazem Hydrochloride SS ORAL 180 MG (90 MG, TWICE DAILY), ORAL Glyceryl Trinitrate C Heptaminol Hydrochloride C Lorazepam C Zopiclone C Paracetamol C Acetylsalicylate Lysine C Clomipramine Hydrochloride C Molsidomine C Donepezil Hydrochloride C Tianeptine C Date:09/23/02ISR Number: 3979580-6Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperdal (Tablet) Initial or Prolonged Blood Creatine Health (Risperidone) PS ORAL MG, DAILY, Phosphokinase Increased Professional ORAL Blood Pressure Increased Haldol (Tablet) Diabetes Mellitus (Haloperidol) SS ORAL MG, DAILY, Hypoventilation ORAL Insomnia Quetiapine Fumarate Respiratory Distress (Quetiapine Schizophrenia Fumarate) SS ORAL MG, DAILY, ORAL Hydroxyzine Pamoate (Hydroxyzine) C Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1410 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/02ISR Number: 3979581-8Report Type:Expedited (15-DaCompany Report #EMADSS2002005250 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Psychotic Disorder Foreign Risperidone (Tablet) Pulmonary Embolism Health (Risperidone) PS ORAL SEE IMAGE Professional Perazine (Perazine) C Tavor (Lorazepam) C Date:09/23/02ISR Number: 3979582-XReport Type:Expedited (15-DaCompany Report #EMADSS2002005262 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Missed Foreign Risperdal PS ORAL 6 MG, DAILY, Initial or Prolonged Complications Of Maternal Health ORAL Required Exposure To Therapeutic Professional Intervention to Drugs Prevent Permanent Foetal Growth Retardation Impairment/Damage Maternal Drugs Affecting Foetus Pregnancy Date:09/23/02ISR Number: 3979583-1Report Type:Expedited (15-DaCompany Report #NSADSS2002032295 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperdal PS ORAL 1MG DAILY Muscle Rigidity Consumer ORAL; 1.5MG Renal Failure DAILY ORAL Tremor Anticholinergic (Anticholinergics) C Date:09/23/02ISR Number: 3980047-XReport Type:Expedited (15-DaCompany Report #NSADSS2002032278 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemolytic Anaemia Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 6 MG, 1 IN 1 DAILY, ORAL Furosemide (Furosemide) C Acetaminophen (Paracetamol) C Asa (Acetylsalicylic Acid) C Digoxin (Digoxin) C Enalapril (Enalapril) C Vitamins (Vitamins) C Senekot (Sennoside A+B) C Trazodone (Trazdone) C Artane (Trihexyphendidyl Hydrochloride) C Prevacid (Lansoprazole) C Metformin (Metformin) C 22-Feb-2006 08:20 AM Page: 1411 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lopressor (Metoprolol Tartrate) C Spironolactone (Spironolactone) C Amitriptyline (Amitriptyline) C "Ligncide" C Date:09/23/02ISR Number: 3980156-5Report Type:Expedited (15-DaCompany Report #NSADSS2002032085 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS ORAL 1 MG, 2 IN 1 Professional DAY (S), ORAL Date:09/24/02ISR Number: 3980912-3Report Type:Expedited (15-DaCompany Report #S02-FRA-01975-01 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apraxia Foreign Seropram (Citalopram Initial or Prolonged Cauda Equina Syndrome Health Hydrobromide) PS ORAL 20 MG QD PO Fall Professional Neurontin Gait Disturbance Other (Gabapentin) SS Hypertonia Galantamine SS Pain In Extremity Risperdal Polyneuropathy (Risperidone) SS Bi-Tildiem (Diltiazem Hydrochloride) SS Colchimax SS Aricept (Donepezil Hydrochloride) C Anafranil (Clomipramine Hydrochloride) C Corvasal (Molsidomine) C Nitriderm Tts (Glyceryl Trinitrate) C Hept-A-Mil (Heptaminol Hydrochloride) C Temesta (Lorazepam) C Imovane (Zopiclone) C Dafalgan (Paracetamol) C Kardegic (Acetylsalicylate Lysine) C Stablon (Tianeptine) C 22-Feb-2006 08:20 AM Page: 1412 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/02ISR Number: 3980955-XReport Type:Expedited (15-DaCompany Report #B0279514A Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Paxil Tablet Intervention to Hallucination, Visual Health (Paroxetine Prevent Permanent Nightmare Professional Hydrochloride) PS ORAL 20 MG; PER Impairment/Damage DAY; ORAL Risperidone Tablet (Risperidone) SS ORAL ORAL Zolpidem C Date:09/24/02ISR Number: 3981277-3Report Type:Expedited (15-DaCompany Report #NSADSS2002032972 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Damage Consumer Risperdal Extrapyramidal Disorder (Unspecified) Nervous System Disorder (Risperidone) PS Neuroleptic Malignant Syndrome Tardive Dyskinesia Date:09/25/02ISR Number: 3981330-4Report Type:Direct Company Report #CTU 177116 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Risperdal 3mg Initial or Prolonged Syndrome Janssen PS Janssen ORAL 3MG 00/11 HS Rhabdomyolysis PO Neurontin 600mg Parke-Davis SS Parke-Davis 600MG 1/1AM 00/11HS Date:09/25/02ISR Number: 3982043-5Report Type:Expedited (15-DaCompany Report #APCDSS2002000988 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cholelithiasis Foreign Risperdal (Tablet) Hospitalization - Dehydration Health (Risperidone) PS ORAL MG, DAILY, Initial or Prolonged Dilatation Intrahepatic Professional ORAL Required Duct Acquired Flunitrazepam Intervention to Haemodialysis (Flunitrazepam) SS ORAL MG, DAILY, Prevent Permanent Renal Failure Acute ORAL Impairment/Damage Rhabdomyolysis Losartan Potassium Urinary Tract Infection (Losartan Potassium) C Carvedilol (Carvedilol) C Date:09/25/02ISR Number: 3982559-1Report Type:Expedited (15-DaCompany Report #NSADSS2002032608 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Risperdal Health (Risperidone) PS ORAL ORAL Professional Aspirin (Acetylsalicylic Acid) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1413 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Alprazolam (Alprazolam) SS ORAL ORAL Date:09/25/02ISR Number: 3982560-8Report Type:Expedited (15-DaCompany Report #NSADSS2002032610 Age:33 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Risperdal Health (Risperidone) PS ORAL ORAL Professional Bupropion (Amfebutamone) SS Date:09/25/02ISR Number: 3982564-5Report Type:Expedited (15-DaCompany Report #NSADSS2002032904 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2, ORAL Date:09/25/02ISR Number: 3982567-0Report Type:Expedited (15-DaCompany Report #NSADSS2002032903 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:09/25/02ISR Number: 3982571-2Report Type:Expedited (15-DaCompany Report #NSADSS2002032627 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:09/25/02ISR Number: 4006371-2Report Type:Periodic Company Report #NSADSS2002026830 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Health Reminyl (Tablet) Professional (Galantamine) PS Company Risperdal Representative (Unspecified) (Risperidone) SS Date:09/27/02ISR Number: 3981612-6Report Type:Expedited (15-DaCompany Report #PHRM2002FR02334 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Foreign Trileptal Initial or Prolonged Health (Oxcarbazepine) Professional Tablet PS ORAL 300 MG, BID , Other ORAL Risperdal 22-Feb-2006 08:20 AM Page: 1414 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) Unknown SS ORAL ORAL Mopral (Omeprazole) Capsule SS ORAL 20 MG, QD, ORAL Date:09/27/02ISR Number: 3982078-2Report Type:Direct Company Report #CTU 177448 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Risperidone PS Janssen Intervention to Pharmaceutical ORAL 10 MG QD ORAL Prevent Permanent Benztropine C Impairment/Damage Dss C Date:09/27/02ISR Number: 3982841-8Report Type:Expedited (15-DaCompany Report #2002003839 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Health Geodon (Ziprasidone Hospitalization - Syndrome Professional Hydrochloride) PS Initial or Prolonged Company Risperdal SS 7 MG Representative Paroxetine Hydrochloride C Benzatropine Mesilate C Famotidine C Date:09/27/02ISR Number: 3983618-XReport Type:Expedited (15-DaCompany Report #APCDSS2002001015 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal (Tablet) Platelet Count Decreased Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Date:09/27/02ISR Number: 3983619-1Report Type:Expedited (15-DaCompany Report #APCDSS2002001031 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperidone (Tablet) Hospitalization - Hypoxic Encephalopathy Health (Risperidone) PS ORAL MG, DAILY, Initial or Prolonged Panic Attack Professional ORAL Vegetamin B (Vegetamin B(R)) SS ORAL 1 TABLE, 1 IN 1 DAILY, ORAL Fluvoxamine Maleate (Fluvoxamine Maleate) SS ORAL MG, DAILY, ORAL Ranitidine Hydrochloride (Ranitidine Hydrochloride) C Zopiclone (Zopiclone) C Flunitrazepam (Flunitrazepam) C 22-Feb-2006 08:20 AM Page: 1415 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Triazolam (Triazolam) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Azulene Sulfonate Sodium C Bifidobacterium (Bifidobacterium) C Domperidone (Unspecified) (Domperidone) C Teprenone (Teprenone) C Date:09/27/02ISR Number: 3983620-8Report Type:Expedited (15-DaCompany Report #EMADSS2002005602 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Risperidone Initial or Prolonged Somnolence Health (Unspecified) Other Urinary Tract Infection Professional (Risperidone) PS TEMPORARY STOP FROM 14-FEB-1999 Eltroxin (Levothyroxine Sodium) C Date:09/27/02ISR Number: 3983621-XReport Type:Expedited (15-DaCompany Report #EMADSS2002005599 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS UNKNOWN 1 MG, DAILY, UNKNOWN Date:09/27/02ISR Number: 3983622-1Report Type:Expedited (15-DaCompany Report #EMADSS2002004738 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Foreign Risperidone Initial or Prolonged Brain Oedema Health (Solution) Fall Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 Grand Mal Convulsion DAILY, ORAL Head Injury Remeron Hyponatraemia (Mirtazapine) SS ORAL 45 MG, DAILY, Nervous System Disorder ORAL Nuclear Magnetic Xanax (Alprazolam) C Resonance Imaging Stilnox (Zolpidem) C Abnormal Concor (Bisoprolol Fumarate) C 22-Feb-2006 08:20 AM Page: 1416 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/02ISR Number: 3984298-XReport Type:Expedited (15-DaCompany Report #B0277524A Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Decreased Foreign Paxil Tablet Initial or Prolonged Epilepsy (Paroxetine Hyponatraemia Hydrochloride) PS ORAL 20 MG PER DAY/ORAL Benzhexol Hydrochloride Capsule (Trihexyphenidyl Hcl) SS ORAL 5 MG / TWICE PER DAY / ORAL Oxazepam Tablet (Oxazepam) SS ORAL 50 MG PER DAY/ ORAL Risperidone Tablet (Risperidone) SS ORAL 2 MG PER DAY / ORAL Risperidone Tablet (Risperidone) SS ORAL 2 MG PER DAY / ORAL Date:09/30/02ISR Number: 3985399-2Report Type:Expedited (15-DaCompany Report #1662589A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Literature Tylenol Analgesic Required Increased Health Unknown PS Intervention to Aspartate Professional Tegretol SS Prevent Permanent Aminotransferase Klonopin SS Impairment/Damage Increased Risperidal SS Condition Aggravated Synthroid C Confusional State Drug Toxicity Lethargy Date:10/01/02ISR Number: 3983558-6Report Type:Expedited (15-DaCompany Report #2002054894 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Zoloft (Sertraline) PS Initial or Prolonged Balance Disorder Health Seroquel (Quetiapine Other Depression Suicidal Professional Fumarate) SS Drooling Buspar (Buspirone Drug Effect Decreased Hydrochloride) SS Drug Interaction Risperdal Dyskinesia (Risperidone) SS Hallucinations, Mixed Verapamil C Insomnia Famotidine C Tremor 22-Feb-2006 08:20 AM Page: 1417 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/02ISR Number: 4027404-3Report Type:Periodic Company Report #2001UW13252 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Tongue Oedema Health Seroquel "Zeneca" PS ORAL 100 MG DAILY Hospitalization - Torticollis Professional PO Initial or Prolonged Risperdal SS 2 MG Zoloft C Buspar C Clonapin C Date:10/02/02ISR Number: 3983878-5Report Type:Direct Company Report #CTU 177790 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dyskinesia Risperdal 0.25 Mg Grimacing Janssen PS Janssen ORAL 0.25 MG PO BID Nortriptyline C Claritin Lortabs C Flonase C Date:10/02/02ISR Number: 3984572-7Report Type:Expedited (15-DaCompany Report #EMADSS2002005753 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:10/02/02ISR Number: 3984574-0Report Type:Expedited (15-DaCompany Report #EMADSS2002005752 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:10/02/02ISR Number: 3984576-4Report Type:Expedited (15-DaCompany Report #EMADSS2002005751 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:10/02/02ISR Number: 3984619-8Report Type:Expedited (15-DaCompany Report #EMADSS2002005748 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1418 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/02ISR Number: 3984620-4Report Type:Expedited (15-DaCompany Report #EMADSS2002005746 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:10/02/02ISR Number: 3985470-5Report Type:Direct Company Report #CTU 177746 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Risperidone PS ORAL 3MG, 1MG QAM, Intervention to ORAL Prevent Permanent Lorazepam Inj C Impairment/Damage Trazodone C Multivitamin Liquid C Docusate Soln C Date:10/02/02ISR Number: 3986150-2Report Type:Expedited (15-DaCompany Report #EMADSS2002005745 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:10/02/02ISR Number: 3986153-8Report Type:Expedited (15-DaCompany Report #EMADSS2002005740 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Date:10/02/02ISR Number: 3986272-6Report Type:Expedited (15-DaCompany Report #EMADSS2002005760 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:10/02/02ISR Number: 3986273-8Report Type:Expedited (15-DaCompany Report #EMADSS2002005756 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1419 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/02ISR Number: 3986274-XReport Type:Expedited (15-DaCompany Report #EMADSS2002005754 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:10/02/02ISR Number: 3986275-1Report Type:Expedited (15-DaCompany Report #EMADS2002005761 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Date:10/02/02ISR Number: 3986277-5Report Type:Expedited (15-DaCompany Report #EMADSS2002005762 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Date:10/02/02ISR Number: 3986278-7Report Type:Expedited (15-DaCompany Report #EMADSS2002005763 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Date:10/02/02ISR Number: 3986280-5Report Type:Expedited (15-DaCompany Report #EMADSS2002005732 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Shock Foreign Risperdal Initial or Prolonged Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:10/02/02ISR Number: 3986285-4Report Type:Expedited (15-DaCompany Report #2002UW12947 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Akathisia Health Seroquel PS 100 MG AM AND Intervention to Dystonia Professional NOON 200 MG Prevent Permanent Grimacing HS Impairment/Damage Tongue Disorder Seroquel SS 50 MG AM & NON 400 MG HS Seroquel SS 50 MG AM & NOON 400 MG HS Seroquel SS 25 MG AM & NOON 400 MG HS Seroquel SS ORAL 400 MG DAILY PO 22-Feb-2006 08:20 AM Page: 1420 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel SS ORAL 400 MG DAILY PO Risperdal SS ORAL 1 MG HS PO Risperdal SS .25 MG AM & NOON 1 MG HS Risperdal SS 0.5 MG AM & NOON 1 MG HS Risperdal SS 1 MG TID Risperdal SS 1 MG AM & NOON 2 MG HS Date:10/02/02ISR Number: 3986573-1Report Type:Expedited (15-DaCompany Report #EMADSS2002005599 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Risperidone) PS 1 MG, DAILY Professional Piracetam (Piracetam) C Tebofortan (Ginkgo Biloba) C Lanitop (Metildigoxin) C Vibramycin (Doxycycline Hyclate) C Date:10/02/02ISR Number: 3987272-2Report Type:Expedited (15-DaCompany Report #NSADSS2002033315 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Consumer Risperdal (4 Mg Initial or Prolonged Phosphokinase Increased Health Tablet) Required Body Temperature Professional (Risperidone) PS ORAL 4 MG, ORAL Intervention to Increased Celexa (Citalopram Prevent Permanent Cachexia Hydrobromide) C Impairment/Damage Hypotension Protonix Neuromyopathy (Pantoprazole) C Insulin (Insulin) C Date:10/02/02ISR Number: 3987273-4Report Type:Expedited (15-DaCompany Report #NSADSS2002033324 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (1 Mg Professional Tablet ) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Date:10/02/02ISR Number: 3987274-6Report Type:Expedited (15-DaCompany Report #NSADSS2002033918 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1421 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/02ISR Number: 3987276-XReport Type:Expedited (15-DaCompany Report #NSADSS2002033384 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Consumer Risperdal (Tablet) Health (Risperidone) PS ORAL ORAL Professional Date:10/03/02ISR Number: 3985277-9Report Type:Expedited (15-DaCompany Report #NSADSS2002034105 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 4 IN 1 DAY(S), ORAL Date:10/03/02ISR Number: 3986152-6Report Type:Expedited (15-DaCompany Report #EMADSS2002005743 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:10/03/02ISR Number: 3986956-XReport Type:Expedited (15-DaCompany Report #2002058798 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Lithane (Lithium) PS ORAL ORAL Initial or Prolonged Dysarthria Professional Risperidone SS Motor Dysfunction Trifluoperazine Overdose Hydrochloride C Somnolence Carbamazepine C Olanzapine C Date:10/03/02ISR Number: 3987844-5Report Type:Expedited (15-DaCompany Report #NSADSS2002033349 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Risperdal Electrocardiogram Qt Literature (Unspecified)(Risper Corrected Interval Health idone) PS ORAL ORAL Prolonged Professional Electromechanical Dissociation Date:10/03/02ISR Number: 3987914-1Report Type:Expedited (15-DaCompany Report #MK200209-0304-1 Age:33 YR Gender:Male I/FU:I Outcome PT Body Temperature Increased C-Reactive Protein Increased Diabetes Mellitus 22-Feb-2006 08:20 AM Page: 1422 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insulin-Dependent Hyperkalaemia Hypophosphataemia Ketoacidosis Report Source Product Role Manufacturer Route Dose Duration Oral Soft Tissue Disorder Foreign Anafranil 75mg Renal Failure Capsules 100 PS 75 MG, BID Tachycardia Solupred SS 80 MG DAILY Tachypnoea Risperdal SS 2MG BID Tooth Disorder Tercian SS 62.5MG DAILY Imovane SS 7.5MG DAILY Clamoxyl SS 500MG TID Date:10/03/02ISR Number: 3987915-3Report Type:Expedited (15-DaCompany Report #EMADSS2002005776 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cogwheel Rigidity Foreign Risperdal (0.5 Mg Initial or Prolonged Confusional State Health Tablet) Extensor Plantar Response Professional (Risperidone) PS ORAL 0.5 MG, Hypertonia DAILY, ORAL Spironolactone (Spironolactone) C Frusemide (Furosemide) C Digoxin (Digoxin) C Quinine Sulphate (Quinine Sulphate) C Date:10/04/02ISR Number: 3988328-0Report Type:Expedited (15-DaCompany Report #EMADSS2002005448 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pharyngitis Foreign Risperdal Thrombocytopenia Health (Unspecified) Professional (Risperidone) PS ORAL 1 IN 1 DAY (S), ORAL Imovane (Zopiclone) C Date:10/04/02ISR Number: 3988331-0Report Type:Expedited (15-DaCompany Report #EMADSS2002005806 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Risperidone) PS ORAL SEE IMAGE Professional Date:10/04/02ISR Number: 3988332-2Report Type:Expedited (15-DaCompany Report #EMADSS2002005789 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Foreign Risperdal Initial or Prolonged Confusional State Health (Risperidone) PS ORAL 0.5 MG, 2 IN Faecaloma Professional 1 DAY (S), ORAL Valproate Sodium (Valproate Sodium) C Frusemide (Furosemide) C 22-Feb-2006 08:20 AM Page: 1423 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/02ISR Number: 3988334-6Report Type:Expedited (15-DaCompany Report #EMADSS2002005801 Age:10 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Foreign Risperdal (.25 Mg Neuroleptic Malignant Health Tablet) Syndrome Professional (Risperidone) PS MEDICATION ERROR (2.5MG) Date:10/04/02ISR Number: 3988336-XReport Type:Expedited (15-DaCompany Report #APCDSS2002001111 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal (Tablet) Restlessness Health (Risperidone) PS ORAL ORAL Professional Haloperidol (Haloperidol) SS Biperiden Hydrochloride (Biperiden Hydrochloride) SS INTRAMUSCULAR IM Antiepileptics (Antiepileptics) C Date:10/04/02ISR Number: 3988433-9Report Type:Expedited (15-DaCompany Report #NSADSS2002034120 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Risperdal Professional (Risperidone) PS ORAL 3 MG, DAILY, ORAL Date:10/04/02ISR Number: 3988435-2Report Type:Expedited (15-DaCompany Report #NSADSS2002034115 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:10/07/02ISR Number: 3989280-4Report Type:Expedited (15-DaCompany Report #EMADSS2002005885 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Insipidus Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Trazolan (Trazodone Hydrochloride) C Date:10/08/02ISR Number: 3986775-4Report Type:Expedited (15-DaCompany Report #NSADSS2002034699 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Risperdal Congestive (Unspecified) Feeling Abnormal (Risperidone) PS ORAL ORAL Trance 22-Feb-2006 08:20 AM Page: 1424 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/02ISR Number: 3989914-4Report Type:Expedited (15-DaCompany Report #NSADSS2002034941 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:10/08/02ISR Number: 3990083-5Report Type:Expedited (15-DaCompany Report #EMADSS2002005933 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Risperdal (4 Mg Initial or Prolonged Health Tablet) Professional (Risperidone) PS ORAL 4 MG, 2 IN 1 DAY(S), ORAL Vitamin B1 (Thiamine Hydrochloride) SS ORAL 6 TABLE, DAILY, ORAL Tercian (Cyamemazine) SS ORAL 400 MG, DAILY, ORAL Date:10/08/02ISR Number: 3990084-7Report Type:Expedited (15-DaCompany Report #EMADSS2002005801 Age:10 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Foreign Risperdal (.25 Mg Neuroleptic Malignant Health Tablet) Syndrome Professional (Risperidone) PS MEDICATION ERROR ( 2.5MG) Lioresal (Baclofen) C Lysanxia (Prazepam) C Date:10/08/02ISR Number: 3993619-3Report Type:Expedited (15-DaCompany Report #B0278608A Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Phosphorus Foreign Amoxil (Capsule Initial or Prolonged Decreased (Amoxicillin) PS ORAL ORAL Body Temperature Cyamemazine Tablet Increased (Cyamemazine) SS ORAL ORAL Diabetes Mellitus Clomipramine Hcl Diabetic Ketoacidosis Tablet (Clomipramine Renal Failure Hcl) SS ORAL ORAL Tachycardia Prednisolone Tablet Tachypnoea (Prednisolone) SS ORAL 80 MG / PER DAY / ORAL Risperidone Tablet (Risperidone) SS ORAL 4 MG / PER DAY / ORAL Amox. Trihyd+Pot. Clavulan C Amisulpride C Zopiclone C 22-Feb-2006 08:20 AM Page: 1425 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/09/02ISR Number: 3991001-6Report Type:Expedited (15-DaCompany Report #NSADSS2002034940 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:10/09/02ISR Number: 3991809-7Report Type:Expedited (15-DaCompany Report #NSADSS2002035567 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Foreign Risperdal Hospitalization - Myocardial Infarction Health (Risperidone) PS ORAL 3 MG, 2 IN Initial or Prolonged Professional DAILY, ORAL 1 YR Clonazepam (Clonazepam) C Date:10/09/02ISR Number: 3991810-3Report Type:Expedited (15-DaCompany Report #APCDSS2002001031 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apallic Syndrome Foreign Risperidone (Tablet) Hospitalization - Cardio-Respiratory Arrest Health (Risperidone) PS ORAL SEE IMAGE Initial or Prolonged Hyperventilation Professional Vegetamin B Hypoxic Encephalopathy (Vegetamin B (R)) SS ORAL 1 TABLE, 1 IN 1 DAILY, ORAL Fluvoxamine Maleate (Fluvoxamine Maleate) SS ORAL SEE IMAGE Ranitidine Hydrochloride (Ranitidine Hydrochloride) C Zopiclone (Zopiclone) C Flunitrazepam (Flunitrazepam) C Triazolam (Triazolam) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Azulene Sulfonate Sodium C Bifidobacterium (Bifidobacterium) C Domperidone (Domperidone) C Teprenone (Teprenone) C Date:10/10/02ISR Number: 3992120-0Report Type:Expedited (15-DaCompany Report #M0907-2002 Age:63 YR Gender:Female I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:20 AM Page: 1426 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Disability PT Report Source Product Role Manufacturer Route Dose Duration Aphasia Mirtazapine PS ORAL 45 MG, ORAL Brain Oedema Risperidone SS ORAL 2 MG, ORAL 3 DAY Brain Scan Abnormal Alprazolam C Contusion Zolpidem C Drug Interaction Bisoprolol Fumarate C Hyponatraemia Laceration Nervous System Disorder Polydipsia Somnolence Vomiting Date:10/10/02ISR Number: 3992731-2Report Type:Expedited (15-DaCompany Report #NSADSS2002026638 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hip Fracture Health Risperdal Hospitalization - Respiratory Disorder Professional (Unspecified) Initial or Prolonged (Risperidone) PS ORAL 1 , 4 IN DAILY, ORAL; SEE IMAGE Date:10/11/02ISR Number: 3991413-0Report Type:Expedited (15-DaCompany Report #NSADSS2002015082 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Risperdal Initial or Prolonged Amenorrhoea (Unspecified) Blood Cholesterol (Risperidone) PS ORAL ORAL Increased Zyprexa (Olanzapine) C Depression Paxil (Paroxetine Drug Level Increased Hydrochloride) C Dyspepsia Fall Haemoglobin Decreased High Risk Sexual Behaviour Insomnia Paranoia Polycystic Ovaries Proteus Infection Weight Increased Date:10/11/02ISR Number: 3991414-2Report Type:Expedited (15-DaCompany Report #NSADSS2002021224 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Consumer Risperdal (0.5 Mg Cardiac Arrest Health Tablet) Professional (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Aricept (Donepezil Hydrochloride) C Fosamax (Alendronate 22-Feb-2006 08:20 AM Page: 1427 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Norvasc (Amlodipine Besilate) C Toprol (Metoprolol) C Nexium (Esomeprazole Magnesium) C Date:10/11/02ISR Number: 3991415-4Report Type:Expedited (15-DaCompany Report #NSADSS2002026976 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 4 MG, DAILY, ORAL Date:10/11/02ISR Number: 3992566-0Report Type:Expedited (15-DaCompany Report #EMADSS2002005994 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Foreign Risperdal (Tablet) Hospitalization - Cardiac Arrest Health (Risperidone) PS ORAL 1.5 MG, Initial or Prolonged Professional DAILY, ORAL; 1 MG, DAILY, ORAL Beloc-Zok (Metoprolol Succinate) SS ORAL 150 MG, DAILY, ORAL Vioxx (Rofecoxib) SS ORAL 50 MG, DAILY, ORAL Coversum Combi (Perindopril) C Date:10/11/02ISR Number: 3992737-3Report Type:Expedited (15-DaCompany Report #APCDSS2002001015 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal (Tablet) Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Date:10/11/02ISR Number: 3992738-5Report Type:Expedited (15-DaCompany Report #EMADSS2002005975 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Foreign Risperdal (1 Mg Initial or Prolonged Increased Health Tablet) Bradycardia Professional (Risperidone) PS ORAL 4 MG, DAILY, Hypotension ORAL Loss Of Consciousness Akineton (Biperiden Malaise Hydrochloride) SS ORAL 2 MG, DAILY, Overdose ORAL Vertigo 22-Feb-2006 08:20 AM Page: 1428 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/02ISR Number: 3992447-2Report Type:Expedited (15-DaCompany Report #NSADSS2002036166 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Neutrophil Count Abnormal Health (Risperidone) PS ORAL 2 MG, DAILY, Professional ORAL Date:10/15/02ISR Number: 3992450-2Report Type:Expedited (15-DaCompany Report #APCDSS2002001177 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Infarction Foreign Risperdal Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Date:10/15/02ISR Number: 3992461-7Report Type:Expedited (15-DaCompany Report #02P-151-0201851-00 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Akineton (Biperiden) Initial or Prolonged Bradycardia Health (Biperiden) PS ORAL 1 MG, 2 IN 1 Dizziness Professional D, PER ORAL Drug Interaction Risperidone Hypotension (Risperidone) SS ORAL 1 MG, 4 IN 1 Malaise D, PER ORAL Nausea Vertigo Date:10/15/02ISR Number: 3992814-7Report Type:Expedited (15-DaCompany Report #2002056926 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Lustral (Sertraline) PS ORAL 75 MG Initial or Prolonged Self Injurious Behaviour Health (DAILY), ORAL Disability Tongue Biting Professional Risperidone SS ORAL 0.5 MG (BID), Company ORAL Representative Melatonin C Valproic Acid C Levothyroxine Sodium C Hydrocortisone C Desmopressin C Date:10/15/02ISR Number: 3993083-4Report Type:Expedited (15-DaCompany Report #NSADSS2002036162 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1429 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/02ISR Number: 3993448-0Report Type:Expedited (15-DaCompany Report #APCDSS2002001072 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperdal Initial or Prolonged Blood Cholinesterase Health (Risperidone) PS ORAL ORAL Decreased Professional Haldol (Haloperidol) SS ORAL ORAL Pyrexia Date:10/15/02ISR Number: 3993449-2Report Type:Expedited (15-DaCompany Report #APCDSS2002001111 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal (Tablet) Restlessness Health (Risperidone) PS ORAL ORAL Professional Haloperidol (Haloperidol) SS Biperiden Hydrochloride (Biperiden Hydrochloride) SS INTRAMUSCULAR IM Antiepileptics (Antiepileptics) C Date:10/15/02ISR Number: 3993450-9Report Type:Expedited (15-DaCompany Report #EMADSS2002006028 Age:62 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rheumatoid Arthritis Foreign Risperdal Health (Risperidone) PS ORAL 4 MG, DAILY, Professional ORAL Celecoxib (Celecoxib) C Thiamine (Thiamine) C Lansoprazole (Lansoprazole) C Aspirn (Acetylsalicylic Acid) C Hydroxychloroquine (Hydroxychloroquine) C Date:10/15/02ISR Number: 3993451-0Report Type:Expedited (15-DaCompany Report #EMADSS2002006067 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Risperdal Cough Health (Risperidone) PS ORAL 8 MG, DAILY, Dyspnoea Professional ORAL Eye Rolling Neuleptil (Periciazine) C Lepticur (Tropatepine Hydrochloride) C Tegretol (Carbamazepine) C Victan (Ethyl Loflazepate) C Ventolin 22-Feb-2006 08:20 AM Page: 1430 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Salbutamol) C Date:10/15/02ISR Number: 3993458-3Report Type:Expedited (15-DaCompany Report #APCDSS2002001072 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Haldol (Haloperidol) PS ORAL ORAL Initial or Prolonged Blood Cholinesterase Health Risperdal Decreased Professional (Risperidone) SS ORAL ORAL Pyrexia Date:10/15/02ISR Number: 3993720-4Report Type:Expedited (15-DaCompany Report #NSADSS2002021968 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:10/15/02ISR Number: 3994014-3Report Type:Direct Company Report #CTU 178612 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Gait Disturbance Zyprexa PS ORAL 30 MG PO QD Hospitalization - Hyperglycaemia Risperdal SS ORAL 3 MG PO BID Initial or Prolonged Hyperkalaemia Lorazepam C Required Hyponatraemia Depakote C Intervention to Mental Status Changes Den Vk C Prevent Permanent Renal Failure Impairment/Damage Somnolence Urinary Incontinence Date:10/16/02ISR Number: 3992983-9Report Type:Direct Company Report #CTU 178836 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Oculogyration Risperidone PS Intervention to Prevent Permanent Impairment/Damage Date:10/16/02ISR Number: 3993015-9Report Type:Expedited (15-DaCompany Report #NSADSS2002032608 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Risperdal Coma Health (Unspecified) Electromechanical Professional (Risperidone) PS ORAL ORAL Dissociation Aspirin (Acetylsalicylic Acid) SS ORAL ORAL Alprazolam SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1431 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/02ISR Number: 4012450-6Report Type:Periodic Company Report #001-0945-M0200173 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Health Neurontin Anxiety Professional (Gabapentin) PS ORAL 1600 MG Emotional Disorder (BID), ORAL Leukopenia Sertraline Hydrochloride(Sertra line Hydrochloride) SS ORAL 200 MG (DAILY), ORAL Risperidone SS 2 MG (DAILY) Alprazolam C Valproate Semisodium C Diphenhydramine Hydrochloride C Date:10/17/02ISR Number: 3995776-1Report Type:Expedited (15-DaCompany Report #NSADSS2002032607 Age:24 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Risperdal Completed Suicide Health (Unspecified) Convulsion Professional (Risperidone) PS ORAL ORAL Miosis Amantadine Urinary Incontinence (Amantadine) SS ORAL ORAL Ventricular Fibrillation Date:10/17/02ISR Number: 3995778-5Report Type:Expedited (15-DaCompany Report #NSADSS2002032610 Age:33 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Literature Risperdal Required Abnormal Faeces Health (Risperidone) PS ORAL ORAL Intervention to Blood Sodium Increased Professional Bupropion Prevent Permanent Cardiac Arrest (Amfebutamone) SS ORAL ORAL Impairment/Damage Catatonia Diphenhydramine Circulatory Collapse (Diphenhydramine) SS ORAL ORAL Disseminated Intravascular Coagulation Haematocrit Decreased Heart Rate Increased Hypertension Medication Error Mental Status Changes Pyrexia Tremor Date:10/17/02ISR Number: 3995917-6Report Type:Expedited (15-DaCompany Report #NSADSS2002032605 Age:38 YR Gender:Female I/FU:I Outcome PT Death Acute Respiratory Required Distress Syndrome Intervention to Completed Suicide Prevent Permanent Drug Screen Positive Impairment/Damage General Physical Health Deterioration Hypotension 22-Feb-2006 08:20 AM Page: 1432 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Oedema Somnolence Report Source Product Role Manufacturer Route Dose Duration Literature Risperdal Health (Risperidone) PS ORAL ORAL Professional Amlodipine (Amlodipine) SS ORAL DAILY, ORAL Trihexyphenidyl (Trihexyphenidyl) SS ORAL ORAL Date:10/17/02ISR Number: 3996111-5Report Type:Expedited (15-DaCompany Report #EMADSS2002005975 Age:14 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal (1 Mg Initial or Prolonged Dizziness Health Tablet) Drug Interaction Professional (Risperidone) PS ORAL 4 MG, DAILY, Hypotension ORAL Malaise Akineton (Biperiden Nausea Hydrochloride) SS ORAL 2 MG, DAILY, Vertigo ORAL Date:10/17/02ISR Number: 3996613-1Report Type:Expedited (15-DaCompany Report #NSADSS2002036425 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Risperdal (4 Mg Professional Tablet) (Risperidone) PS ORAL 4 MG, 1 IN 1 NIGHT (S), ORAL Date:10/18/02ISR Number: 3992239-4Report Type:Expedited (15-DaCompany Report #WAES 0209DEU00157 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Health Vioxx PS Merck & Co., Inc ORAL 6 DAY Hospitalization - Cardiac Arrest Professional Metoprolol Succinate SS ORAL Initial or Prolonged Drug Interaction Risperidone SS ORAL Indapamide And Perindopril Erbumine C ORAL Date:10/18/02ISR Number: 3996498-3Report Type:Expedited (15-DaCompany Report #NSADSS2002036734 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Hospitalization - Professional (Unspecified) Initial or Prolonged (Risperidone) PS ORAL ORAL Date:10/18/02ISR Number: 3996499-5Report Type:Expedited (15-DaCompany Report #NSADSS2002036936 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) 22-Feb-2006 08:20 AM Page: 1433 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) PS ORAL ORAL Date:10/18/02ISR Number: 3996535-6Report Type:Expedited (15-DaCompany Report #NSADSS2002037230 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:10/18/02ISR Number: 3996548-4Report Type:Expedited (15-DaCompany Report #NSADSS2002037247 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:10/18/02ISR Number: 3996752-5Report Type:Expedited (15-DaCompany Report #APCDSS2002001072 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Haldol (Unspecified) Initial or Prolonged Blood Cholinesterase Health (Haloperidol) PS ORAL ORAL Decreased Professional Risperdal Pyrexia (Unspecified) (Risperidone) SS ORAL ORAL Date:10/18/02ISR Number: 3997450-4Report Type:Expedited (15-DaCompany Report #2002058798 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Lithane (Lithium) PS ORAL ORAL Initial or Prolonged Dysarthria Professional Risperidone SS Pneumonia Trifluoperazine Somnolence Hydrochloride C Carbamazepine C Olanzapine C Date:10/18/02ISR Number: 3997789-2Report Type:Expedited (15-DaCompany Report #APCDSS2002001072 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperdal Initial or Prolonged Blood Cholinesterase Health (Unspecified) Decreased Professional (Risperidone) PS ORAL ORAL Chemical Poisoning Haladol Pyrexia (Unspecified) (Haloperidol) SS ORAL ORAL Date:10/21/02ISR Number: 3995620-2Report Type:Direct Company Report #CTU 179133 Age: Gender:Male I/FU:I Outcome PT Other Akathisia Rash 22-Feb-2006 08:20 AM Page: 1434 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Urticaria Report Source Product Role Manufacturer Route Dose Duration Risperidone 2 Mg PS ORAL 1 MG BID ORAL Benztropine C Diphenhydramine C Haloperidol C Lorazepam C Risperidone C Temazepam C Date:10/21/02ISR Number: 3998254-9Report Type:Expedited (15-DaCompany Report #2002058798 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Lithane (Lithium) PS ORAL ORAL Initial or Prolonged Drug Level Increased Professional Risperidone SS Dysarthria Trifluoperazine Nervous System Disorder Hydrochloride C Pneumonia Carbamazepine C Pyrexia Olanzapine C Somnolence Hydrocortisone C Neomycin C Date:10/21/02ISR Number: 3998749-8Report Type:Expedited (15-DaCompany Report #EMADSS2002006209 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Risperdal (4 Mg Hospitalization - Circulatory Collapse Health Tablet) Initial or Prolonged Sinus Tachycardia Professional (Risperidone) PS ORAL SEE IMAGE Company Deroxat (Paroxetine Representative Hydrochloride) C Akineton (Biperiden Hydrochloride) C Tranxene (Clorazepate Dipotassium) C Tercian (Cyamemazine) C Stilnox (Zolpidem) C Sulfarlem (Anethole Trithione) C Date:10/22/02ISR Number: 3995988-7Report Type:Direct Company Report #CTU 179199 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Parkinsonism Risperidone PS Date:10/23/02ISR Number: 3999410-6Report Type:Expedited (15-DaCompany Report #A0383149A Age:33 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Wellbutrin Health Unspecified Tablet Professional (Bupropion 22-Feb-2006 08:20 AM Page: 1435 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) PS ORAL ORAL Risperidone (Formulation Unknown) (Risperidone) SS Diphenhydramine (Formulation Unknown) (Diphenhydramine) SS Date:10/23/02ISR Number: 3999569-0Report Type:Expedited (15-DaCompany Report #NSADSS2002037580 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:10/25/02ISR Number: 3998334-8Report Type:Direct Company Report #CTU 179641 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cerebrovascular Accident Risperidal 2 M PS Depression Clonazepan 0.5 SS Feeling Abnormal Tremor Date:10/25/02ISR Number: 4000468-9Report Type:Expedited (15-DaCompany Report #NSADSS2002038139 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Literature Risperdal Required Increased Health (Risperidone) PS ORAL ORAL Intervention to Aspartate Professional Tylenol Prevent Permanent Aminotransferase (Paracetamol) SS Impairment/Damage Increased Tegretol Completed Suicide (Carbamazepine) SS Condition Aggravated Klonopin Confusional State (Clonazepam) SS Drug Level Above Synthroid C Therapeutic Lethargy Date:10/25/02ISR Number: 4000775-XReport Type:Expedited (15-DaCompany Report #EMADSS2002006339 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Petechiae Foreign Risperdal (Tablet) Initial or Prolonged Thrombocytopenia Health (Risperidone) PS ORAL 4 MG, DAILY, Professional ORAL Cardiac Medications (Cardiac Therapy) C 22-Feb-2006 08:20 AM Page: 1436 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/02ISR Number: 4000777-3Report Type:Expedited (15-DaCompany Report #EMADSS2002006308 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Hyperglycaemic Foreign Risperdal Initial or Prolonged Coma Health (Unspecified) Professional (Risperidone) PS Thioridazine (Thioridazine) C Carbamazepine (Carbamazepine) C Date:10/25/02ISR Number: 4000778-5Report Type:Expedited (15-DaCompany Report #EMADSS2002006280 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Decreased Appetite Foreign Risperdal Endocrine Disorder Health (Unspecified) Hypercholesterolaemia Professional (Risperidone) PS 3 TO 4 MG Weight Increased Efexor (Venlafaxine Hydrochloride) C Stilnox (Zolpidem) C Date:10/28/02ISR Number: 3999418-0Report Type:Direct Company Report #CTU 179714 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Joint Stiffness Risperidone PS Date:10/28/02ISR Number: 3999423-4Report Type:Direct Company Report #CTU 179717 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Risperidone PS Date:10/28/02ISR Number: 4000642-1Report Type:Direct Company Report #CTU 179750 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Risperidone PS 1.5MG Q AM ; 2MG Q HS Divalproex Sodium C Date:10/28/02ISR Number: 4002480-2Report Type:Expedited (15-DaCompany Report #EMADSS2002003855 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Risperidone Pulmonary Embolism Health (Unspecified) Sudden Death Professional (Risperidone) PS 1 MG BD, 3 MG NOCTE Diazepam (Diazepam) C Fluoxetine (Fluoxetine) C 22-Feb-2006 08:20 AM Page: 1437 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/02ISR Number: 4002556-XReport Type:Expedited (15-DaCompany Report #021015-PM0003-00 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Tranxene Health (Clorazepate Professional Dipotassium) PS ORAL 10.0 MG P.O. Other 5 TIMES/DAY Chloral Hydrate SS ORAL P.O. 2 OR 3 SPOONS/DAY Risperidone SS ORAL 4.0 MG P.O. QD Macrogol SS Nicotinamide SS ORAL 500.0 MG P.O. QD Cyamemazine SS ORAL 25.0 MG P.O. 12 TIMES / DAY Eugynon C Paracetamol C Maalox C Date:10/28/02ISR Number: 4002629-1Report Type:Expedited (15-DaCompany Report #021022-PM0004-00 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Tranxene Initial or Prolonged Fall Health (Clorazepate Professional Dipotassium) PS ORAL 10 MG, P.O. Other BID Zolpidem SS 10 MG, P.O. QD Lithium Carbonate SS ORAL P.O. Amitriptyline Hydrochloride SS ORAL 25 MG, P.O. QD Risperidone SS ORAL 1 MG, P.O. QD Date:10/29/02ISR Number: 4001261-3Report Type:Direct Company Report #CTU 179865 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neuroleptic Malignant Risperdal PS ORAL AM AND HS 1 Intervention to Syndrome MG PO Prevent Permanent Ativan SS ORAL AM AND HS 0.5 Impairment/Damage MG PO 1 DAY Date:10/29/02ISR Number: 4001346-1Report Type:Expedited (15-DaCompany Report #APCDSS2002001248 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperidone (Tablet) Health (Risperidone) PS ORAL ORAL Professional Haloperidol (Haloperidol) SS ORAL ORAL Sodium Valproate (Valproate Sodium) SS ORAL ORAL Paroxetine Hydrochloride 22-Feb-2006 08:20 AM Page: 1438 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrate (Paroxetine Hydrochloride) C Paroxetine Hydrochloride C Date:10/29/02ISR Number: 4001350-3Report Type:Expedited (15-DaCompany Report #EMADSS2002005760 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperdal) PS ORAL 1 MG, DAILY, ORAL Ramipril (Ramipril) C Date:10/29/02ISR Number: 4001352-7Report Type:Expedited (15-DaCompany Report #EMADSS2002005761 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Enalapril/Lisinopril SS ENALAPRIL 10MG AND LISINOPRIL 10MG Zolpidem (Zolpidem) C Hydergine (Hydergin) C Date:10/29/02ISR Number: 4001354-0Report Type:Expedited (15-DaCompany Report #EMADSS2002005762 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG, DAILY, ORAL Glibenclamide (Glibenclamide) C Ticlopidine (Ticlopidine) C Date:10/29/02ISR Number: 4001355-2Report Type:Expedited (15-DaCompany Report #EMADSS2002005763 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1439 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/02ISR Number: 4001356-4Report Type:Expedited (15-DaCompany Report #EMADSS2002006413 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Disorder Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL 0.5 MG, DAILY, ORAL; 1 MG, DAILY, ORAL Ticlopidine (Ticlopidine) C Date:10/29/02ISR Number: 4001357-6Report Type:Expedited (15-DaCompany Report #EMADSS2002006410 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG, DAILY, ORAL; 1 MG, DAILY, ORAL; 3 MG, DAILY, ORAL Date:10/29/02ISR Number: 4003126-XReport Type:Expedited (15-DaCompany Report #EMADSS2002006389 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Foreign Reminyl (Tablet) Sudden Death Health (Galantamine) PS ORAL 8 MG, 2 IN 1 Syncope Professional DAY(S), ORAL Risperdal (Tablet) (Risperidone) SS ORAL 0.5 TABLE,2 IN1 DAY(S), ORAL Date:10/29/02ISR Number: 4003129-5Report Type:Expedited (15-DaCompany Report #APCDSS2002001248 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Haloperidol Health (Haloperidol) PS ORAL ORAL Professional Riseperidone (Tablet) (Risperidone) SS ORAL ORAL Sodium Valproate (Valproate Sodium) SS ORAL ORAL Paroxetine Hydrochloride Hydrate (Paroxetine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1440 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/02ISR Number: 4003592-XReport Type:Expedited (15-DaCompany Report #NSADSS2002038666 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Risperdal (Tablet) Leukopenia Professional (Risperidone) PS ORAL ORAL Polypharmacy C Date:10/30/02ISR Number: 4003594-3Report Type:Expedited (15-DaCompany Report #NSADSS2002038963 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL ORAL Professional Date:10/30/02ISR Number: 4003597-9Report Type:Expedited (15-DaCompany Report #NSADSS2002038538 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 DAILY; 3 MG 1 IN 1 NIGHT(S) ORAL Date:10/30/02ISR Number: 4004507-0Report Type:Expedited (15-DaCompany Report #PHEH2002US09217 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Health Tegretol Increased Professional (Carbamazepine) PS ORAL ORAL Aspartate Acetaminophen Aminotransferase (Paracetamol) SS Increased Klonopin Completed Suicide (Clonazepam) SS Confusional State Risperdal Lethargy (Risperidone) SS Synthroid C Date:10/31/02ISR Number: 4002118-4Report Type:Direct Company Report #CTU 180057 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Risperdal PS Clonidin C Date:10/31/02ISR Number: 4003061-7Report Type:Direct Company Report #CTU 180102 Age:62 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged Other Required Intervention to Prevent Permanent 22-Feb-2006 08:20 AM Page: 1441 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Difficulty In Walking Risperdal 1mg Tablet Dysphagia Janssen PS Jannsen 1MG DAILY X Joint Stiffness 10 DAYS THEN Somnolence 1MG TWICE Tremor DAILY Vomiting Ec Aspirin C Levothyroxine C Multivitamins C Calcium W/ Vit D C Pericolace C Pbn Ointment C Prevacid C Tylenol C Lithium C Date:10/31/02ISR Number: 4003107-6Report Type:Direct Company Report #CTU 180103 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Risperdal 1mg Tablet Initial or Prolonged Dysphagia Jannen PS Jannen 1MG DAILY X Other Joint Stiffness 10 DAYS THEN Required Somnolence 1 MG TWICE A Intervention to Tremor DAY Prevent Permanent Vomiting Ec Aspirin C Impairment/Damage Levathyroxine C Multivitamins C Calcium W/ Vit D C Pericolace C Pbn Ointment C Prevacid C Tylenol C Lithium C Date:10/31/02ISR Number: 4004454-4Report Type:Expedited (15-DaCompany Report #EMADSS2002006500 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Risperidone Initial or Prolonged Head Banging Health (Unspecified) Self Injurious Behaviour Professional (Risperidone) PS ORAL 0.25 MG, 2 IN Tongue Biting 1 DAILY, ORAL 1 MON Lustral (Sertraline Hydrochloride) SS DOSE HAS BEEN INCREASED Sodium Valproate (Valproate Acid) C Thyroxine (Levothyroxine Sodium) C Hydrocortisone (Hydrocortisone) C Desmopressin (Desmopressin) C Melatonin (Melatonin) C 22-Feb-2006 08:20 AM Page: 1442 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/31/02ISR Number: 4004456-8Report Type:Expedited (15-DaCompany Report #EMADSS2002006339 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Petechiae Foreign Risperdal (Tablet) Initial or Prolonged Thrombocytopenia Health (Risperidone) PS ORAL 4 MG, DAILY , Professional ORAL Ass (Acetylsalicylic Acid) C Plavix (Clopidogrel Sulfate) C (Pantozol (Pantoprazole Sodium) C Delix (Ramipril) C Zocor (Simvastatin) C Tavor (Lorazepam) C Zolpidem (Zolpidem) C Beloc Zok Mite (Metoprolol Succinate) C Date:10/31/02ISR Number: 4004457-XReport Type:Expedited (15-DaCompany Report #EMADSS2002006130 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Abscess Foreign Risperdal Initial or Prolonged Health (Unspecified) Professional (Risperidone) PS ORAL 4 MG, DAILY, ORAL Deroxat (Paroxetine Hydrochloride) C Effexor (Venlafaxine Hydrochloride) C Date:10/31/02ISR Number: 4004466-0Report Type:Expedited (15-DaCompany Report #NSADSS2002035567 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Foreign Risperdal Hospitalization - Myocardial Infarction Health (Unspecified) Initial or Prolonged Professional (Risperidone) PS ORAL 3 MG, 2 IN DAILY, ORAL 1 YR Clonazepam (Clonazepam) C Date:10/31/02ISR Number: 4004471-4Report Type:Expedited (15-DaCompany Report #EMADSS2002005762 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG, DAILY, ORAL Glibenclamide (Glibenclamide) C Ticlopidine (Ticlopidine) C 22-Feb-2006 08:20 AM Page: 1443 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/31/02ISR Number: 4004473-8Report Type:Expedited (15-DaCompany Report #EMADSS2002006413 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL SEE IMAGE ORAL Ticlopidine (Ticlopidine) C Date:10/31/02ISR Number: 4004614-2Report Type:Expedited (15-DaCompany Report #EMADSS2002001032 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal Initial or Prolonged Health (Risperidone) PS ORAL SEE IMAGE, Professional DAILY, ORAL Lorazepam (Lorazepam) C Flunitrazepam (Flunitrazepam) C Date:10/31/02ISR Number: 4004885-2Report Type:Expedited (15-DaCompany Report #NSADSS2002039102 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:11/01/02ISR Number: 4005266-8Report Type:Expedited (15-DaCompany Report #NSADSS2002038971 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Consumer Concerta (18 Mg Initial or Prolonged Fall Sustained Release Required Formication Tablet) Intervention to Gait Disturbance (Methylphenidate Prevent Permanent Hallucination Hydrochloride) PS ORAL 18 MG, 1 IN 1 Impairment/Damage Movement Disorder DAY(S), ORAL Pelvic Pain Risperdal Self Mutilation (Risperidone) SS Tic Clonidine Tourette'S Disorder (Clonidine) SS Date:11/01/02ISR Number: 4005268-1Report Type:Expedited (15-DaCompany Report #APCDSS2002001273 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Haldol (Unspecified) Health (Haloperidol) PS MG, DAILY Professional Risperidone (Unspecified) (Risperidone) SS ORAL MG, DAILY; ORAL 22-Feb-2006 08:20 AM Page: 1444 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/02ISR Number: 4005485-0Report Type:Expedited (15-DaCompany Report #EMADSS2002006453 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Gait Disturbance Health (Unspecified) Rhinorrhoea Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Aricept (Donepezil Hydrochloride) SS ORAL 10 MG, DAILY, ORAL Fosicomp (Elidiur) C Date:11/04/02ISR Number: 4006041-0Report Type:Expedited (15-DaCompany Report #NSADSS2002038971 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Consumer Risperdal Initial or Prolonged Fall (Risperidone) PS ORAL Required Formication Concerta (18 Mg Intervention to Gait Disturbance Sustained Release Prevent Permanent Hallucination Tablet)(Methylphenid Impairment/Damage Intentional Self-Injury ate Hydrochloride) SS ORAL 18 MG, 1 IN 1 Paralysis DAY(S), ORAL Pelvic Pain Clonidine Tourette'S Disorder (Clonidine) SS Date:11/05/02ISR Number: 4003900-XReport Type:Direct Company Report #CTU 180340 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anger Risperadrol PS Condition Aggravated Depression Muscle Twitching Tardive Dyskinesia Date:11/05/02ISR Number: 4006056-2Report Type:Expedited (15-DaCompany Report #NSADSS2002039720 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:11/05/02ISR Number: 4006063-XReport Type:Expedited (15-DaCompany Report #NSADSS200239743 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS 22-Feb-2006 08:20 AM Page: 1445 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/05/02ISR Number: 4006079-3Report Type:Expedited (15-DaCompany Report #NSADSS2002039337 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:11/05/02ISR Number: 4006085-9Report Type:Expedited (15-DaCompany Report #NSADSS2002039749 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:11/05/02ISR Number: 4006764-3Report Type:Expedited (15-DaCompany Report #HQ4986031OCT2002 Age:33 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Overdose Literature Diphenhydramine Hcl (Diphenhydramine Hydrochloride, Injection) PS OVERDOSE AMOUNT UNKNOWN Bupropion (Amfebutamone, ) SS OVERDOSE AMOUNT UNKNOWN Risperidone (Risperidone, ) SS OVERDOSE AMOUNT UNKNOWN Date:11/05/02ISR Number: 4006867-3Report Type:Expedited (15-DaCompany Report #APCDSS2002001228 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Foreign Risperdal Arrhythmia Health (Unspecified) Dizziness Professional (Risperidone) PS ORAL MG, DAILY, Sedation ORAL Nifedipine(Nifedipin e) C Mianserin Hydrochloride (Mianserin Hydrochloride) C Date:11/06/02ISR Number: 4007786-9Report Type:Expedited (15-DaCompany Report #2002058798 Age:55 YR Gender:Male I/FU:F Outcome PT Hospitalization - Coordination Abnormal Initial or Prolonged Csf Lymphocyte Count Abnormal Csf White Blood Cell Count Positive 22-Feb-2006 08:20 AM Page: 1446 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysarthria Medication Error Nervous System Disorder Report Source Product Role Manufacturer Route Dose Duration Overdose Health Lithane (Lithium) PS ORAL ORAL Pneumonia Professional Risperidone SS Pneumonia Aspiration Trifluoperazine Pyrexia Hydrochloride C Somnolence Carbamazepine C Olanzapine C Neomycin C Date:11/06/02ISR Number: 4008485-XReport Type:Expedited (15-DaCompany Report #APCDSS2002001273 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Haldol (Unspecified) Disturbance In Attention Health (Haloperidol) PS ORAL MG, DAILY, Fatigue Professional ORAL Hallucination, Auditory Risperidone Malaise (Unspecified) Muscle Rigidity (Risperidone) SS ORAL MG, DAILY, Somnolence ORAL Treatment Noncompliance Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Date:11/06/02ISR Number: 4008488-5Report Type:Expedited (15-DaCompany Report #EMADSS2002006603 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Risperdal (1 Mg Hospitalization - Depressed Level Of Health Tablet) Initial or Prolonged Consciousness Professional (Risperidone) PS ORAL 4 MG, DAILY, Hepatic Failure ORAL Hyperkalaemia Zocor (Simvastatin) SS ORAL 4 MG, DAILY, Mydriasis ORAL Neuroleptic Malignant Prozac (Fluoxetine Syndrome Hydrochloride) SS Renal Failure Acute Lepticur Rhabdomyolysis (Tropatepine Thrombocytopenia Hydrochloride) C Anafranil (Clompramine Hydrochloride) C Depamide (Valpromide) C Hept-A-Myl (Heptaminol Hydrochloride) C Temesta (Lorazepam) C 22-Feb-2006 08:20 AM Page: 1447 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/02ISR Number: 4008598-2Report Type:Expedited (15-DaCompany Report #EMADSS2002005933 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Risperdal (4 Mg Initial or Prolonged Lymphadenopathy Health Tablet) Mass Professional (Risperidone) PS ORAL 4 MG, 2 IN 1 Neutrophil Count DAY (S), ORAL Decreased Vitamin B1 (Thiamine Oedema Hydrochloride) SS ORAL 6 TABLE, Pyrexia DAILY, ORAL Splenomegaly Tercian White Blood Cell Count (Cyamemazine) SS ORAL 400MG, DAILY Decreased Date:11/07/02ISR Number: 4008599-4Report Type:Expedited (15-DaCompany Report #APCDSS2002001015 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Risperidone) PS ORAL MG, DAILY, Professional ORAL Date:11/07/02ISR Number: 4008880-9Report Type:Expedited (15-DaCompany Report #EMADSS2002006655 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cellulitis Foreign Risperidone Difficulty In Walking Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAY (S), ORAL Date:11/07/02ISR Number: 4008885-8Report Type:Expedited (15-DaCompany Report #EMADSS2002006604 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteritis Foreign Risperdal ( Fluid Overload Health Unspecified) Lung Disorder Professional (Risperidone) PS ORAL ORAL Pulmonary Artery Thrombosis Date:11/07/02ISR Number: 4008886-XReport Type:Expedited (15-DaCompany Report #EMADSS2002005743 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS DOSE INCREASED FROM 0.5MG TO 1MG AFTER 3 MONTHS 22-Feb-2006 08:20 AM Page: 1448 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/02ISR Number: 4008888-3Report Type:Expedited (15-DaCompany Report #EMADSS2002005745 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Date:11/07/02ISR Number: 4008891-3Report Type:Expedited (15-DaCompany Report #EMADSS2002005754 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG, ORAL Date:11/07/02ISR Number: 4008893-7Report Type:Expedited (15-DaCompany Report #EMADSS2002005756 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperal Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG, DAILY, ORAL 2 MON Date:11/07/02ISR Number: 4009085-8Report Type:Expedited (15-DaCompany Report #NSADSS2002037224 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:11/07/02ISR Number: 4009088-3Report Type:Expedited (15-DaCompany Report #NSADSS2002037220 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:11/07/02ISR Number: 4009090-1Report Type:Expedited (15-DaCompany Report #NSADSS2002037227 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:11/08/02ISR Number: 4009358-9Report Type:Expedited (15-DaCompany Report #NSADSS2002040064 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Health Risperdal Malignant Professional (Unspecified) 22-Feb-2006 08:20 AM Page: 1449 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) PS ORAL ORAL Date:11/08/02ISR Number: 4009761-7Report Type:Expedited (15-DaCompany Report #MK200209-0304-3 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Foreign Anafranil 75 Mg C-Reactive Protein Capsules PS 75 MG BID Increased Risperdal SS 2 MG BID Dehydration Tercian SS 62.5MG DAILY Diabetes Mellitus Clamoxyl SS 500MG BID Insulin-Dependent Solupred SS 80MG DAILY Glycosylated Haemoglobin Imovane C Increased Hypercapnia Hyperglycaemia Hyperkalaemia Hypophosphataemia Ketoacidosis Ketonuria Renal Failure Tachycardia Tachypnoea Tooth Disorder Date:11/08/02ISR Number: 4009791-5Report Type:Expedited (15-DaCompany Report #EMADSS2002005748 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Risperidone) PS ORAL 1 MG, DAILY, Professional ORAL Date:11/08/02ISR Number: 4009879-9Report Type:Expedited (15-DaCompany Report #EMADSS2002005740 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Risperidone) PS 1 MG, DAILY Professional Date:11/08/02ISR Number: 4009882-9Report Type:Expedited (15-DaCompany Report #NSADSS2002040229 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Health (Risperidone) PS 1 MG, DAILY Professional Amitriptyline (Amitriptyline) C Date:11/08/02ISR Number: 4009883-0Report Type:Expedited (15-DaCompany Report #NSADSS2002040068 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemorrhagic Stroke Foreign Risperdal Hemiparesis Health (Risperidone) PS ORAL ORAL Professional 22-Feb-2006 08:20 AM Page: 1450 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/02ISR Number: 4009885-4Report Type:Expedited (15-DaCompany Report #EMADSS2002005746 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Risperidone) PS ORAL 1 MG, DAILY, Professional ORAL Date:11/08/02ISR Number: 4009886-6Report Type:Expedited (15-DaCompany Report #EMADSS2002005751 Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Risperidone) PS INCREASED Professional AFTER 1MONTH THEN REDUCED AT MONTH 3 Date:11/08/02ISR Number: 4009900-8Report Type:Expedited (15-DaCompany Report #EMADSS2002005753 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Risperidone) PS DOSE Professional INCREASED AFTER 1 MONTH Date:11/08/02ISR Number: 4011752-7Report Type:Expedited (15-DaCompany Report #NSADSS2002039888 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ankle Fracture Health Risperdal (0.5 Mg Fall Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Ferrous Sulfate (Ferrous Sulfate) C Aspirin (Acetylsalicylic Acid) C Tylenol No 3 (Tylenol No 3) C Magnesium Oxide (Magnesium Oxide) C Calcium (Calcium) C Fosamax (Alendronate Sodium) C Seroquel (Seroquel) C Date:11/12/02ISR Number: 4008396-XReport Type:Direct Company Report #CTU 180805 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dizziness Risperdal 1 Mg PS ORAL 1 MG BID ORAL Fall Loss Of Consciousness 22-Feb-2006 08:20 AM Page: 1451 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/12/02ISR Number: 4010310-8Report Type:Expedited (15-DaCompany Report #EMADSS2002006656 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Contusion Foreign Risperidone Lymphocyte Count Health (Risperidone) PS ORAL 6 MG, DAILY, Decreased Professional ORAL Platelet Count Decreased Flupentixol (Flupentixol) C Trifluoperazine (Trifluoperazine) C Dothiepin (Dosulepin) C Procyclidine (Procyclidine) C Date:11/12/02ISR Number: 4010694-0Report Type:Expedited (15-DaCompany Report #EMADSS2002006756 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Risperdal (2 Mg Phosphokinase Increased Health Tablet) Professional (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY(S), ORAL Taxilan (Perazine) C Atosil (Isopromethazine Hydrochloride) C Date:11/12/02ISR Number: 4010695-2Report Type:Expedited (15-DaCompany Report #EMADSS2002006731 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal (Tablet) Health (Risperidone) PS ORAL 3 MG, DAILY, Professional ORAL Cipramil (Citalopram) C Date:11/12/02ISR Number: 4029792-0Report Type:Periodic Company Report #PHEH2002US07808 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Gamma-Glutamyltransferase Health Trileptal(Oxcarbazep Decreased Professional ine) Unknown PS ORAL 225MG/QAM AND Haematocrit Decreased Company 150 MG/QHS, Haemoglobin Decreased Representative ORAL Risperdal(Risperidon e) SS ORAL 0.5MG, QHS, ORAL Date:11/13/02ISR Number: 4010778-7Report Type:Expedited (15-DaCompany Report #2002063204 Age:54 YR Gender:Male I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Blood Alkaline 22-Feb-2006 08:20 AM Page: 1452 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphatase Increased Gamma-Glutamyltransferase Increased Psychotic Disorder Report Source Product Role Manufacturer Route Dose Duration Foreign Sertraline Health (Sertraline) PS ORAL 200 MG Professional (DAILY), ORAL Company Risperidone SS ORAL 4 MG (TWICE A Representative DAY), ORAL Baclofen C Buspirone Hydrochloride C Date:11/13/02ISR Number: 4012239-8Report Type:Expedited (15-DaCompany Report #NSADSS2002040781 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:11/13/02ISR Number: 4012240-4Report Type:Expedited (15-DaCompany Report #NSADSS2002040779 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:11/13/02ISR Number: 4012242-8Report Type:Expedited (15-DaCompany Report #NSADSS2002040787 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Health Risperdal Professional (Unspecified) (Risperidone) PS Date:11/14/02ISR Number: 4012429-4Report Type:Expedited (15-DaCompany Report #EMADSS2002006715 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Upper Gastrointestinal Foreign Risperdal Haemorrhage Health (Risperidone) PS ORAL 1 MG ; 2MG : Professional DAILY, ORAL Date:11/14/02ISR Number: 4012430-0Report Type:Expedited (15-DaCompany Report #EMADSS2002006716 Age:94 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Risperidone Infarction Health (Risperidone) PS ORAL 0.5 MG, Professional DAILY, ORAL Nitroglicerine (Glyceryl Trinitrate) C Salicilic Acid (Salicylic Acid) C 22-Feb-2006 08:20 AM Page: 1453 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Furosemide (Furosemide) C Metamizol (Metamizole) C Clorazepate (Clorazepate Dipotassium) C Date:11/14/02ISR Number: 4012431-2Report Type:Expedited (15-DaCompany Report #EMADSS2002006717 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Risperdal Infarction Health (Risperidone) PS ORAL 0.5 MG, Respiratory Failure Professional DAILY, ORAL Lorazepam (Lorazepam) C Digoxine (Digoxin) C Ranitidine (Ranitidine) C Salicilic Acid (Salicylic Acid) C Date:11/14/02ISR Number: 4012432-4Report Type:Expedited (15-DaCompany Report #EMADSS2002006718 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Foreign Risperdal Cardio-Respiratory Arrest Health (Risperidone) PS ORAL 0.5 MG, Professional DAILY, ORAL Salicylic Acid (Salicylic Acid) C Date:11/14/02ISR Number: 4012433-6Report Type:Expedited (15-DaCompany Report #EMADSS2002006726 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hip Fracture Foreign Risperdal Pneumonia Health (Risperidone) PS ORAL 0.5 MG, Professional DAILY, ORAL Diltiazem (Diltiazem) C Selegiline (Selegiline) C Date:11/14/02ISR Number: 4012434-8Report Type:Expedited (15-DaCompany Report #EMADSS2002006729 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hip Fracture Foreign Risperdal Health (Risperidone) PS ORAL 1 MG, DAILY, Professional ORAL 22-Feb-2006 08:20 AM Page: 1454 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/02ISR Number: 4012584-6Report Type:Expedited (15-DaCompany Report #EMADSS2002006719 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG, DAILY, ORAL Furosemide (Furosemide) C Alopurinol (Allopurinol) C Date:11/14/02ISR Number: 4012585-8Report Type:Expedited (15-DaCompany Report #EMADSS2002006721 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Digoxina (Digoxin) C Enalapril 20 (Enalapril) C Furosemide (Furosemide) C Amoxiciline (Amoxicillin) C Date:11/14/02ISR Number: 4012586-XReport Type:Expedited (15-DaCompany Report #EMADSS2002006724 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, DAILY , ORAL ; 2 MG, DAILY , ORAL Furosemide (Furosemide) C Date:11/14/02ISR Number: 4012587-1Report Type:Expedited (15-DaCompany Report #EMADSS2002005760 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Ramipril (Ramipril) C Date:11/15/02ISR Number: 4010198-5Report Type:Expedited (15-DaCompany Report #B0284912A Age: Gender:Male I/FU:F Outcome PT Hospitalization - Cryptorchism Initial or Prolonged Drug Withdrawal Syndrome 22-Feb-2006 08:20 AM Page: 1455 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neonatal Inguinal Hernia Maternal Drugs Affecting Foetus Report Source Product Role Manufacturer Route Dose Duration Seroxat PS Glaxo Wellcome 40MG per day Deprakine SS 600MG per day Risperidal SS 1MG per day Temesta SS 6.25MG per day Date:11/15/02ISR Number: 4013401-0Report Type:Expedited (15-DaCompany Report #NSADSS2002030863 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (3 Mg Health Tablet) Professional (Risperidone) PS ORAL 3 MG, 1 IN 1 DAY (S), ORAL Paxil (Paroxetine Hydrochloride) C Date:11/15/02ISR Number: 4013402-2Report Type:Expedited (15-DaCompany Report #NSADSS2002031108 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:11/15/02ISR Number: 4013403-4Report Type:Expedited (15-DaCompany Report #NSADSS2002040258 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAY (S), ORAL Phenergan (Promethazine Hydrochloride) C Date:11/15/02ISR Number: 4013406-XReport Type:Expedited (15-DaCompany Report #NSADSS2002040263 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 2.5, DAILY, ORAL Date:11/15/02ISR Number: 4013408-3Report Type:Expedited (15-DaCompany Report #NSADSS2002040288 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Risperdal Professional (Unspecified) (Risperidone) PS 22-Feb-2006 08:20 AM Page: 1456 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/02ISR Number: 4013412-5Report Type:Expedited (15-DaCompany Report #NSADSS2002040452 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 1, 2 IN DAILY, ORAL Date:11/15/02ISR Number: 4014269-9Report Type:Expedited (15-DaCompany Report #APCDSS2002001228 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Foreign Risperdal Initial or Prolonged Arrhythmia Health (Unspecified) Other Body Temperature Professional (Risperidone) PS ORAL MG, DAILY, Decreased ORAL Dizziness Nifedipine Heart Rate Decreased (Nifedipine) C Ventricular Extrasystoles Mianserin Hydrochloride (Mianserin Hydrorchloride) C Lactose (Lactose) C Date:11/15/02ISR Number: 4014270-5Report Type:Expedited (15-DaCompany Report #EMADSS2002005448 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal (4 Mg Health Tablet) Professional (Risperidone) PS ORAL 4 MG, 1 IN 1 DAY (S), ORAL Imovane (Zopiclone) C Depamide (Valpromide) C Rulid (Roxithromycin) C Lepticur (Tropatepine Hydrochloride) C Dafalgan (Paracetamol) C Hept-A-Myl (Heptaminol Hydrochloride) C Sulfarlem (Anethole Trithione) C Clamoxyl (Amoxicillin Trihydrate) C Maxilase (Amylase) C Date:11/15/02ISR Number: 4014272-9Report Type:Expedited (15-DaCompany Report #EMADSS2002006810 Age:89 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Creatinine Abnormal Initial or Prolonged Blood Urea Abnormal 22-Feb-2006 08:20 AM Page: 1457 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fall Tremor Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG, NIGHT (S), ORAL Ramipril (Ramipril) C Frusemide (Furosemide) C Cetirizine (Cetirizine) C Iron (Iron) C Sertraline (Sertraline) C Clopidogrel (Clopidogrel) C Date:11/15/02ISR Number: 4014273-0Report Type:Expedited (15-DaCompany Report #EMADSS2002006748 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 1.5 MG, DAILY, ORAL Loperamide (Unspecified) (Loperamide) C Fluoxetine (Fluoxetine) C Atenolol (Atenolol) C Date:11/15/02ISR Number: 4014549-7Report Type:Expedited (15-DaCompany Report #NSADSS2002040630 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Consumer Risperdal (1 Mg Initial or Prolonged Fatigue Tablet) Nervousness (Risperidone) PS DURATION 3-4 Oral Intake Reduced MONTHS Restlessness Prozac (Fluoxetine Hydrochloride) C Date:11/18/02ISR Number: 4011206-8Report Type:Expedited (15-DaCompany Report #WAES 0211ESP00010 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Crixivan PS Merck & Co., Inc ORAL Hospitalization - Coordination Abnormal Ritonavir SS ORAL Initial or Prolonged Drug Interaction Risperidone SS ORAL Mania Zidovudine C ORAL Miosis Didanosine C ORAL 22-Feb-2006 08:20 AM Page: 1458 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/18/02ISR Number: 4013464-2Report Type:Expedited (15-DaCompany Report #EMADSS2002006748 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 1.5 MG, DAILY, ORAL Loperamide (Unspecified) (Loperamide) C Fluoxetine (Fluoxetine) C Atenolol (Atenolol) C Date:11/18/02ISR Number: 4013465-4Report Type:Expedited (15-DaCompany Report #EMADSS2002004742 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoglycaemic Coma Foreign Risperdal (1 Mg Initial or Prolonged Ketoacidosis Health Tablet) Psychotic Disorder Professional (Risperidone) PS ORAL 3 MG, DAILY, Restlessness ORAL Litarex (Lithium Citrate) SS ORAL 6 MMOL, DAILY, ORAL Furosemide (Furosemide) C Atarax (Hydroxyzine Hydrochloride) C Fludent (Sodium Fluoride) C Dimetikon (Dimeticone) C Stesolid (Diazepam) C Hermolepsin Retard (Carbamazepine) C Oxascand (Oxazepam) C Zocord (Simvastatin) C Tromblyl (Acetylsalicylic Acid) C Imovane (Zopiclone) C Date:11/18/02ISR Number: 4013467-8Report Type:Expedited (15-DaCompany Report #EMADSS2002006856 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal Initial or Prolonged Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:11/18/02ISR Number: 4013468-XReport Type:Expedited (15-DaCompany Report #EMADSS2002006873 Age:1 DY Gender:Male I/FU:I Outcome PT Hospitalization - Cryptorchism Initial or Prolonged Drug Withdrawal Syndrome Inguinal Hernia 22-Feb-2006 08:20 AM Page: 1459 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maternal Drugs Affecting Foetus Neonatal Disorder Report Source Product Role Manufacturer Route Dose Duration Foreign Resperdal Health (Unspecified) Professional (Risperidone) PS ORAL MOTHER TOOK 0.5MG TABLET, BD, PO Deprakine (Valproate Sodium) SS ORAL MOTHER TOOK 300MG TABLET, BD, PO Seroxat (Paroxetine Hydrochloride) SS ORAL MOTHET TOOK 20MG TABLET, BD, PO Temesta (Lorazepam) C Date:11/18/02ISR Number: 4013474-5Report Type:Expedited (15-DaCompany Report #EMADSS2002006903 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Risperdal Initial or Prolonged Increased Health (Unspecified) Aspartate Professional (Risperidone) PS ORAL MG, DAILY, Aminotransferase ORAL; SEE Increased IMAGE Blood Alkaline Stangyl Phosphatase Increased (Trimipramine Gamma-Glutamyltransferase Maleate) SS ORAL MG, DAILY, Increased ORAL; SEE Hepatomegaly IMAGE Liver Disorder Planum (Temazepam) C Remergil (Mirtazapine) C Tavor (Lorazepam) C Praxiten (Oxazepam) C Date:11/18/02ISR Number: 4013482-4Report Type:Expedited (15-DaCompany Report #APCDSS2002001344 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Date:11/18/02ISR Number: 4013483-6Report Type:Expedited (15-DaCompany Report #APCDSS2002001364 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Risperidone (Tablet) Hospitalization - Diabetes Mellitus Health (Risperidone) PS ORAL ORAL Initial or Prolonged Professional Milnacipran Hydrochloride (Milnacipran) SS ORAL ORAL Levomepromazine Maleate (Levomepromazine 22-Feb-2006 08:20 AM Page: 1460 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maleate) SS ORAL ORAL Date:11/19/02ISR Number: 4012752-3Report Type:Direct Company Report #CTU 181283 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chronic Obstructive Risperidone PS 3 MG BID Pulmonary Disease Kcl C Dyspnoea Lasix C Hypoxia Lorazepam C Leukopenia Ceftriaxone C Pneumonia Methylpred C Thrombocytopenia Date:11/19/02ISR Number: 4012755-9Report Type:Direct Company Report #CTU 181290 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Risperdal PS 2 MG QHS Initial or Prolonged Depressed Level Of CHRONIC Consciousness Metolazone SS 5 QD CHRONIC Grand Mal Convulsion Bumetanide SS ORAL 2 PO BID Hyperphagia CHRONIC Hyponatraemia Calcium Carb C Zocor C Aspirin C Quinine C Isosorbide C Insulin C Iron C Zoloft C Date:11/19/02ISR Number: 4014606-5Report Type:Expedited (15-DaCompany Report #NSADSS2002023225 Age:93 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (1 Mg Hospitalization - Professional Tablet) Initial or Prolonged (Risperidone) PS ORAL ORAL Date:11/20/02ISR Number: 4015144-6Report Type:Expedited (15-DaCompany Report #APCDSS2002001376 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Risperdal Circulatory Collapse Health (Unspecified) Condition Aggravated Professional (Risperidone) PS 0.5 MG, 2 IN Memory Impairment 1 DAY (S) 3 MON Speech Disorder Date:11/20/02ISR Number: 4015981-8Report Type:Expedited (15-DaCompany Report #EMADSS2002006903 Age:53 YR Gender:Female I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate 22-Feb-2006 08:20 AM Page: 1461 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Blood Alkaline Phosphatase Increased Report Source Product Role Manufacturer Route Dose Duration Gamma-Glutamyltransferase Foreign Risperdal Increased Health (Unspecified) Hepatic Function Abnormal Professional (Risperidone) PS ORAL SEE IMAGE Liver Disorder Stangyl (Trimipramine Maleate) SS ORAL SEE IMAGE Planum (Temazepam) C Remergil (Mirtazapine) C Tavor (Lorazepam) C Praxiten (Oxazepam) C Date:11/21/02ISR Number: 4016676-7Report Type:Expedited (15-DaCompany Report #HQ5210612NOV2002 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Health Temesta (Lorazepam, Initial or Prolonged Neonatal Professional Tablet) PS ORAL 6.25 MG 1X Other Inguinal Hernia Other PER 1 DAY; Maternal Drugs Affecting ORAL Foetus Deprakine (Valproate Testicular Disorder Sodium, ) SS 600 MG 1X PER 1 DAY; Risperdal (Risperidone, ) SS 1 MG 1X PER 1 DAY; Seroxat (Paroxetine Hydrochloride, ) SS 40 MG 1X PER 1 DAY; Date:11/21/02ISR Number: 4016933-4Report Type:Expedited (15-DaCompany Report #EMADSS2002005746 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Date:11/21/02ISR Number: 4016934-6Report Type:Expedited (15-DaCompany Report #EMADSS2002005356 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fatigue Foreign Risperdal Hyperthyroidism Health (Unspecified) Weight Increased Professional (Risperidone) PS ORAL 2 MG, DAILY, ORAL Clomipramine (Clomipramine) C Flixotide (Fluticasone Propionate) C 22-Feb-2006 08:20 AM Page: 1462 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/02ISR Number: 4016936-XReport Type:Expedited (15-DaCompany Report #EMADSS2002006936 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Supraventricular Foreign Risperidone Extrasystoles Health (Unspecified) Supraventricular Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 Tachycardia DAILY, ORAL Ventricular Extrasystoles Ventricular Tachycardia Date:11/21/02ISR Number: 4016959-0Report Type:Expedited (15-DaCompany Report #EMADSS2002005357 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Foreign Risperdal Health (Risperidone) PS Professional Date:11/21/02ISR Number: 4016973-5Report Type:Expedited (15-DaCompany Report #EMADSS2002006993 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Risperdal Initial or Prolonged Health (Risperidone) PS ORAL SEE IMAGE Professional Ximovan (Zopiclone) C Pantozol (Pantoprazole Sodium) C Allopurinol (Allopurinol) C Folsan (Folic Acid) C Date:11/21/02ISR Number: 4016976-0Report Type:Expedited (15-DaCompany Report #APCDSS2002001364 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Ph Decreased Foreign Risperidone (Tablet) Hospitalization - Diabetes Mellitus Health (Risperidone) PS ORAL MG, DAILY, Initial or Prolonged Diabetic Hyperglycaemic Professional ORAL Coma Milnacipran Hydrochloride (Milnacipran) SS ORAL MG, DAILY, ORAL Levomepromazine Maleate (Levomepromazine Maleate) SS ORAL MG, DAILY, ORAL Date:11/21/02ISR Number: 4017340-0Report Type:Expedited (15-DaCompany Report #NSADSS2002042011 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 1463 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/02ISR Number: 4017341-2Report Type:Expedited (15-DaCompany Report #NSADSS2002041522 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Risperdal (0.5 Mg Congestive Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Date:11/22/02ISR Number: 4016040-0Report Type:Expedited (15-DaCompany Report #APCDSS2002001364 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Risperidone (Tablet) Hospitalization - Diabetic Coma Health (Risperidone) PS ORAL MG, DAILY, Initial or Prolonged Diabetic Ketoacidosis Professional ORAL Milnacipran Hydrochloride (Milnacipran) SS ORAL MG, DAILY, ORAL Levomepromazine Maleate (Levomepromazine Maleate) SS ORAL MG, DAILY, ORAL Date:11/22/02ISR Number: 4016406-9Report Type:Expedited (15-DaCompany Report #FLUV00302002900 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Galactorrhoea Foreign Floxyfral Hyperprolactinaemia Other (Fluvoxamine Maleate) PS ORAL DAILY, PO 1 MON Risperdal (Risperidone) SS ORAL DAILY PO Surmontil (Trimipramine) SS ORAL DAILY, PO 1 MON Solian (Amisulpride) SS Akineton (Biperiden Hydrochloride) C Date:11/25/02ISR Number: 4014428-5Report Type:Expedited (15-DaCompany Report #B0284890A Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradykinesia Paroxetine PS Glaxo Wellcome ORAL 20MG Per day Initial or Prolonged Decreased Appetite Risperidone SS ORAL 6MG per day 12 DAY Disability Muscle Rigidity Chlorpromazine Neuroleptic Malignant Hydrochloride SS Glaxo Wellcome ORAL 50MG per day Syndrome Nitrazepam C ORAL 10MG per day Date:11/25/02ISR Number: 4016238-1Report Type:Expedited (15-DaCompany Report #NSADSS2002041916 Age: Gender:Female I/FU:I Outcome Death Hospitalization - 22-Feb-2006 08:20 AM Page: 1464 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Dyskinesia Consumer Risperdal Lethargy (Unspecified) Neuroleptic Malignant (Risperidone) PS Syndrome Pneumonia Aspiration Pseudomonas Infection Urinary Tract Infection Date:11/25/02ISR Number: 4017355-2Report Type:Expedited (15-DaCompany Report #EMADSS2002006748 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Risperidone) PS ORAL 1.5 MG, Professional DAILY, ORAL Loperamide (Loperamide) C Fluoxetine (Fluoxetine) C Atenolol (Atenolol) C Date:11/25/02ISR Number: 4017390-4Report Type:Expedited (15-DaCompany Report #MK200211-0201-1 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Literature Clomipramine (Mfr Condition Aggravated Unknown) PS 300 MG, Depression BEDTIME Grand Mal Convulsion Interferon Beta-1a SS 30UG/WEEK Multiple Sclerosis Propranolol SS 300MG DAILY Parkinsonism Risperidone SS 3MG DAILY Salivary Hypersecretion Guanfacine C Tic Oxcarbazepine C Date:11/25/02ISR Number: 4017407-7Report Type:Expedited (15-DaCompany Report #EMADSS2002005448 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pharyngitis Foreign Risperdal (4 Mg Thrombocytopenia Health Tablet) Professional (Risperidone) PS ORAL 4 MG, 1 IN 1 DAY (S), ORAL Imovane (Zopiclone) C Depamide (Valpromide) C Rulid (Roxithromycin) C Lepticur (Tropatepine Hydrochloride) C Dafalgan (Paracetamol) C Hept-A-Myl (Heptaminol Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1465 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sulfarlem (Anethole Trithione) C Clamoxyl (Amoxicillin Trihydrate) C Maxilase (Amylase) C Date:11/26/02ISR Number: 4017884-1Report Type:Expedited (15-DaCompany Report #EMADSS2002006280 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Foreign Risperdal Drug Ineffective Health (Unspecified) Hypercholesterolaemia Professional (Risperidone) PS ORAL SEE IMAGE Weight Increased Efexor (Venlafaxine Hydrochloride) C Stilnox (Zolpidem) C Date:11/26/02ISR Number: 4017885-3Report Type:Expedited (15-DaCompany Report #NSADSS2002030440 Age:74 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Risperdal Other Syndrome Health (Unspecified) Professional (Risperidone) PS ORAL 0.25 MG, DAILY, ORAL Date:11/26/02ISR Number: 4017889-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB03612 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Ritaline Initial or Prolonged Erectile Dysfunction Health (Methylphenidate Disability Priapism Professional Hydrochloride) Other Tablet PS ORAL 30 MG/DAY, ORAL Risperidone (Risperidone) SS ORAL ONCE/SINGLE, ORAL Date:11/26/02ISR Number: 4017983-4Report Type:Expedited (15-DaCompany Report #NSADSS2002041840 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Risperdal Initial or Prolonged First Degree Literature (Unspecified) Coma Health (Risperidone) PS 6 MG, DAILY Eating Disorder Professional Nifedipine Heart Rate Decreased (Nifedipine) C Hypotension Bendrofluazide Hypothermia (Bendroflumethiazide Lethargy ) C Loss Of Consciousness Procyclidine Respiratory Arrest (Procyclidine) C Feospan (Ferrous Sulfate Exsiccated) C Lactulose 22-Feb-2006 08:20 AM Page: 1466 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Lactulose) C Date:11/26/02ISR Number: 4018019-1Report Type:Expedited (15-DaCompany Report #2002058798 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Lithane (Lithium) PS ORAL ORAL Initial or Prolonged Csf Test Abnormal Professional Risperidone SS Dysarthria Trifluoperazine Mental Status Changes Hydrochloride C Motor Dysfunction Carbamazepine C Nervous System Disorder Olanzapine C Overdose Hydrocortisone C Pneumonia Aspiration Neomycin C Pyrexia Somnolence Date:11/26/02ISR Number: 4018070-1Report Type:Expedited (15-DaCompany Report #NSADSS2002042474 Age:6 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Accidental Exposure Health Risperdal Intervention to Dystonia Professional (Risperidone) PS 2 DOSES (5 MG Prevent Permanent EACH) Impairment/Damage Date:11/27/02ISR Number: 4017187-5Report Type:Direct Company Report #CTU 181828 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Depakote PS ORAL PO X 1 Initial or Prolonged Ammonia Increased Trazodone SS ORAL PO X 1 Intentional Self-Injury Cogentin SS ORAL PO X 1 Lethargy Risperdal SS ORAL PO X 1 Vomiting Date:11/27/02ISR Number: 4018990-8Report Type:Expedited (15-DaCompany Report #2002AP03376 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Seroquel PS 50 MG DAILY Death Health PO Drug Effect Decreased Professional Seroquel SS 200 MG DAILY Other PO Risperdal SS 1 MG DAILY PO Risperdal SS 2 MG DAILY PO Flumezin C Eurodin C Hirnamin C Rohypnol C Halcion C Glucose W/Electrolytes C Aspara K C Pyrethia C 22-Feb-2006 08:20 AM Page: 1467 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/27/02ISR Number: 4019059-9Report Type:Expedited (15-DaCompany Report #NSADSS2002042702 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (4 Mg Health Tablet) Professional (Risperidone) PS ORAL 4 MG, 1 IN DAY(S); ORAL Date:11/27/02ISR Number: 4019060-5Report Type:Expedited (15-DaCompany Report #NSADSS2002042465 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Prolactin Increased Consumer Risperdal Intervention to Breast Cancer (Unspecified) Prevent Permanent (Risperidone) PS ORAL ORAL Impairment/Damage Date:11/27/02ISR Number: 4019204-5Report Type:Expedited (15-DaCompany Report #EMADSS2002005448 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pharyngitis Foreign Risperdal (4 Mg Thrombocytopenia Health Tablet) Professional (Risperidone) PS ORAL 4 MG, 1 IN 1 DAY (S), ORAL Imovane (Zopiclone) C Depamide (Valpromide) C Rulid (Roxithromycin) C Lepticur (Tropatepine Hydrochloride) C Dafalgan (Paracetamol) C Hept-A-Myl (Heptaminol Hydrochloride) C Sulfarlem (Amethole Trithione) C Clamoxyl (Amoxicillin Trihydrate) C Maxilase (Amylase) C Date:11/27/02ISR Number: 4019578-5Report Type:Expedited (15-DaCompany Report #A044-002-003936 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Foreign Aricept (Donepezil) PS ORAL 10 MG, 1 IN 1 Health D PER ORAL Professional Risperdal (Risperidone) SS ORAL 6 MG, PER ORAL 22-Feb-2006 08:20 AM Page: 1468 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/02ISR Number: 4019144-1Report Type:Expedited (15-DaCompany Report #EMADSS2002007214 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Risperidone Initial or Prolonged Somnolence Health (Solution) Professional (Risperidone) PS ORAL SEE IMAGE Date:11/29/02ISR Number: 4019158-1Report Type:Expedited (15-DaCompany Report #EMADSS2002006389 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Reminyl (Tablet) Sudden Death Health (Galantamine) PS ORAL 4 MG, 2 IN 1 Syncope Professional DAY(S), ORAL; 8 MG, 2 IN 1 DAY(S), ORAL Risperdal (Tablet) (Risperidone) SS ORAL 1 MG, DAILY, ORAL Equanil (Meprobamate) C Date:11/29/02ISR Number: 4019232-XReport Type:Expedited (15-DaCompany Report #EMADSS2002005748 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Risperidone) PS ORAL 0.5 MG, Professional DAILY, ORAL Date:11/29/02ISR Number: 4019517-7Report Type:Expedited (15-DaCompany Report #NSADSS2002043103 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (3 Mg Health Tablet) Professional (Risperidone) PS ORAL 3 MG, DAILY, ORAL Date:11/29/02ISR Number: 4019520-7Report Type:Expedited (15-DaCompany Report #NSADSS2002043084 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY (S), ORAL Date:12/02/02ISR Number: 4018294-3Report Type:Direct Company Report #CTU 181963 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Jaundice Phenytoin PS Initial or Prolonged Liver Function Test Risperidone SS Abnormal 22-Feb-2006 08:20 AM Page: 1469 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/02/02ISR Number: 4018461-9Report Type:Direct Company Report #CTU 181953 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Back Pain Risperdal 1mg Difficulty In Walking Janssen PS Janssen ORAL 1MG ONCE A Dystonia DAY ORAL Pain In Extremity Seroquel 25mg Zeneca SS Zeneca ORAL 50MG 3X DAY ORAL Zoloft C Cogentin C Neurontin C Date:12/02/02ISR Number: 4020409-8Report Type:Expedited (15-DaCompany Report #2000AH04985 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Foreign Candesartan Initial or Prolonged Difficulty In Walking Study Cilexetil PS 1 TABLET Face Oedema Health DAILY Somnolence Professional Trazolan SS Other Risperdal SS 75 MG DAILY Ascardia C Cedocard C Cystrin C Transipeg C Seroxat "Novo Nordisk" C Novo Nordisk Date:12/03/02ISR Number: 4018206-2Report Type:Expedited (15-DaCompany Report #B0286643A Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Paxil PS Glaxo Wellcome Anger Lithium SS Glaxo Wellcome Anxiety Risperidone SS Depression Gabapentin SS Drug Ineffective Insomnia Suicidal Ideation Date:12/03/02ISR Number: 4018266-9Report Type:Expedited (15-DaCompany Report #B0286643A Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Paxil PS Glaxo Wellcome Anger Lithium SS Glaxo Wellcome Anxiety Risperidone SS Bipolar Disorder Gabapentin SS Drug Ineffective Insomnia Malaise Suicidal Ideation 22-Feb-2006 08:20 AM Page: 1470 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/02ISR Number: 4021026-6Report Type:Expedited (15-DaCompany Report #APCDSS2002001421 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Risperdal Condition Aggravated Health (Unspecified) Neutropenia Professional (Risperidone) PS UNKNOWN Viral Infection Date:12/03/02ISR Number: 4021028-XReport Type:Expedited (15-DaCompany Report #NSADSS2002043358 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:12/03/02ISR Number: 4021030-8Report Type:Expedited (15-DaCompany Report #NSADSS2002043523 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS Date:12/03/02ISR Number: 4021042-4Report Type:Expedited (15-DaCompany Report #PERCOCET2002-00411 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Literature Percocet Endo PS Endo ORAL PO Completed Suicide Health Vicodin Knoll SS Knoll ORAL PO Hepatic Failure Professional Oxycodone SS ORAL PO Respiratory Depression Risperidone SS ORAL PO Valproic Acid SS ORAL PO Gabapentin SS ORAL PO Meloxicam SS ORAL PO Date:12/03/02ISR Number: 4021386-6Report Type:Expedited (15-DaCompany Report #02P-055-0204744-00 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cryptorchism Foreign Depakine Tablets Initial or Prolonged Drug Withdrawal Syndrome Health (Sodium Valproate) Neonatal Professional (Sodium Valproate) Hernia (Sodium Valproate) PS TRANSPLACENTAL TRANSPLACENTA Maternal Drugs Affecting L Foetus Paroxetine Neonatal Disorder Hydrochloride SS TRANSPLACENTAL TRANSPLACENTA L Risperidone SS TRANSPLACENTAL TRANSPLACENTA L Date:12/03/02ISR Number: 4021482-3Report Type:Expedited (15-DaCompany Report #APCDSS2002000824 Age:68 YR Gender:Female I/FU:I Outcome PT Death Coma Disseminated Intravascular Coagulation 22-Feb-2006 08:20 AM Page: 1471 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Renal Impairment Report Source Product Role Manufacturer Route Dose Duration Rhabdomyolysis Foreign Risperdal Shock Health (Tablet)(Risperidone Professional ) PS ORAL MG, DAILY, ORAL Maprotiline Hydrochloride(Maprot iline Hydrochloride) C Flunitrazepam (Flunitrazepam) C Brotizolam (Brotizolam) C Mefenamic Acid(Mefenamic Acid) C Triazolam (Triazolam) C Date:12/03/02ISR Number: 4021484-7Report Type:Expedited (15-DaCompany Report #APCDSS2002001419 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Neutrophil Count Abnormal Health (Tablet)(Risperidone Professional ) PS Company Representative Date:12/03/02ISR Number: 4021490-2Report Type:Expedited (15-DaCompany Report #EMADSS2002007222 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Macular Degeneration Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Date:12/04/02ISR Number: 4022392-8Report Type:Expedited (15-DaCompany Report #APCDSS2002001364 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Foreign Risperidone (Tablet) Hospitalization - Cold Sweat Health (Risperidone) PS ORAL MG, DAILY, Initial or Prolonged Coma Professional ORAL Depressed Level Of Milnacipran Consciousness Hydrochloride Diabetes Mellitus (Milnacipran) SS ORAL MG, DAILY, Diabetic Ketoacidosis ORAL Drug Effect Decreased Levomepromazine Fall Maleate Major Depression (Levomepromazine Nasopharyngitis Maleate) C Nausea Pallor Peripheral Coldness 22-Feb-2006 08:20 AM Page: 1472 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/04/02ISR Number: 4022396-5Report Type:Expedited (15-DaCompany Report #EMADSS2002007355 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cystitis Foreign Risperdal (Solution) Extrapyramidal Disorder Health (Risperidone) PS ORAL 0.5 MG, Keratoconjunctivitis Professional DAILY, ORAL ; Sicca 0.25 MG, DAILY, ORAL Date:12/05/02ISR Number: 4021655-XReport Type:Expedited (15-DaCompany Report #APCDSS2002001376 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Risperdal(Unspecifie Confusional State Health d) (Risperidone) PS 0.5 MG, 2 IN Depressed Level Of Professional 1 DAY(S) 3 MON Consciousness Dystonia Flat Affect Hyporeflexia Kyphosis Mobility Decreased Parkinsonian Gait Somnolence Date:12/05/02ISR Number: 4021916-4Report Type:Expedited (15-DaCompany Report #NSADSS2002043527 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (1 Mg Professional Tablet)(Risperidone) PS ORAL 1 MG, 1 IN 24 HOUR (S), ORAL Date:12/05/02ISR Number: 4021918-8Report Type:Expedited (15-DaCompany Report #EMADSS2002007426 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Insipidus Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:12/05/02ISR Number: 4022298-4Report Type:Expedited (15-DaCompany Report #2002-11-2655 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Consumer Clarinex Electrocardiogram Company (Desloratadine) Abnormal Representative Tablets PS ORAL ORAL Risperdal SS Eskalith Capsules SS 22-Feb-2006 08:20 AM Page: 1473 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/06/02ISR Number: 4020364-0Report Type:Direct Company Report #CTU 182184 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperidone PS Date:12/06/02ISR Number: 4021622-6Report Type:Expedited (15-DaCompany Report #OXYT000031 (0) Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Roxicodone Health (Oxycodone Hcl) PS ORAL ORAL Professional Colchicine (Colchicine) SS ORAL ORAL Risperidone (Risperidone) SS ORAL ORAL Date:12/06/02ISR Number: 4022495-8Report Type:Expedited (15-DaCompany Report #NSADSS2002034940 Age:65 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Risperdal Professional (Unpspecified) (Risperidone) PS ORAL ORAL Date:12/06/02ISR Number: 4022523-XReport Type:Expedited (15-DaCompany Report #NSADSS2002043521 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:12/06/02ISR Number: 4022600-3Report Type:Expedited (15-DaCompany Report #B0285160A Age:33 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Diphenhydramine Health Hydrochloride Professional (Formulation Unknown) (Diphenhydramine PS ORAL ORAL Risperidone (Formulation Unknown) (Risperidone) SS ORAL ORAL Wellbutrin (Formulation Unknown) (Bupropion Hydrochloride) SS ORAL ORAL Date:12/09/02ISR Number: 4023917-9Report Type:Expedited (15-DaCompany Report #EMADSS2002005420 Age:39 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:20 AM Page: 1474 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Peripheral Embolism Foreign Risperdal(Unspecifie Priapism Health d) (Risperidone) PS ORAL 0.5 MG, 1 IN Professional 1 NIGHT(S), ORAL Haloperidol (Haloperidol) C Date:12/10/02ISR Number: 4022003-1Report Type:Direct Company Report #CTU 182479 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Risperdal 2mg Jannsen PS Jannsen 2MG Q 12H Date:12/10/02ISR Number: 4024902-3Report Type:Expedited (15-DaCompany Report #NSADSS2002044709 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bundle Branch Block Right Literature Haldol (Unspecified) Hospitalization - Cardiac Arrest Health (Haloperidol) PS ORAL 5 MG, 2 IN 1 Initial or Prolonged Catatonia Professional DAY(S), ORAL Circulatory Collapse Risperdal Coma (Unspecified) Electrocardiogram Qt (Risperidone) SS ORAL SEE IMAGE Corrected Interval Amantadine Prolonged (Amantadine) C Electromechanical Lorazepam Dissociation (Lorazepam) C Grand Mal Convulsion Clozapine Loss Of Consciousness (Clozapine) C Orthostatic Hypotension Supraventricular Extrasystoles Tonic Clonic Movements Date:12/10/02ISR Number: 4025020-0Report Type:Expedited (15-DaCompany Report #NSADSS2002044709 Age:34 YR Gender:Female I/FU:I Outcome PT Death Aphasia Hospitalization - Back Pain Initial or Prolonged Blood Pressure Systolic Decreased Bundle Branch Block Right Cardiac Arrest Chest Wall Pain Convulsion Electrocardiogram Qrs Complex Abnormal Electrocardiogram Qrs Complex Prolonged Electromechanical Dissociation Flat Affect Loss Of Consciousness 22-Feb-2006 08:20 AM Page: 1475 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Orthostatic Hypotension Pain In Extremity Pharyngolaryngeal Pain Report Source Product Role Manufacturer Route Dose Duration Pyrexia Literature Risperdal Schizophrenia, Paranoid Health (Risperidone) PS ORAL SEE IMAGE Type Professional Haldol (Haloperidol) SS ORAL 5 MG, 2 IN 1 Supraventricular DAY(S), ORAL Extrasystoles Amantadine Ventricular Extrasystoles (Amantadine) C White Blood Cell Count Lorazepam Increased (Lorazepam) C Clozapine (Clozapine) C Date:12/10/02ISR Number: 4025023-6Report Type:Expedited (15-DaCompany Report #NSADSS2002037224 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death No Adverse Drug Effect Health Risperdal Professional (Unspecified) (Risperidone) PS Date:12/10/02ISR Number: 4025118-7Report Type:Expedited (15-DaCompany Report #EMADSS2002007546 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Risperdal Complications Of Maternal Health (Unspecfied) Exposure To Therapeutic Professional (Risperidone) PS Drugs Maternal Drugs Affecting Foetus Date:12/10/02ISR Number: 4025119-9Report Type:Expedited (15-DaCompany Report #APCDSS2002000824 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Foreign Risperdal (Tablet) Chest Pain Health (Risperidone) PS ORAL MG, DAILY, Coma Professional ORAL Depressed Level Of Maprotiline Consciousness Hydrochloride Disseminated (Maprotiline Intravascular Coagulation Hydrochloride) C Drug Dependence Flunitrazepam Heart Rate Increased (Flunitrazepam) C Nasopharyngitis Brotizolam Neuroleptic Malignant (Brotizolam) C Syndrome Mefenamic Acid Shock (Mefenamic Acid) C Triazolam (Triazolam) C 22-Feb-2006 08:20 AM Page: 1476 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/02ISR Number: 4025360-5Report Type:Expedited (15-DaCompany Report #B0281063A Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Constipation Foreign Paxil Tablet Depression Literature (Paroxetine Diabetes Mellitus Health Hydrochloride) PS ORAL ORAL Drug Interaction Professional Risperidone Dry Mouth (Formulation Hyperlipidaemia Unknown) Weight Increased (Risperidone) SS ORAL ORAL Date:12/11/02ISR Number: 4021748-7Report Type:Direct Company Report #CTU 182532 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Zyprexa PS Platelet Count Abnormal Risperdal SS Red Blood Cell Count Glipizide C Abnormal Mvi C Red Cell Distribution Trazadone C Width Increased Zyprexa C White Blood Cell Count Ilithium C Abnormal Date:12/11/02ISR Number: 4022283-2Report Type:Direct Company Report #CTU 182523 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Rispiridone PS Initial or Prolonged Ibuprofen C Venlofoxine C Date:12/11/02ISR Number: 4024530-XReport Type:Expedited (15-DaCompany Report #EMADSS2002004273 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Fibrosis Foreign Risperdal (2 Mg Initial or Prolonged Hepatic Steatosis Health Tablet) Influenza Professional (Risperidone) PS ORAL SEE IMAGE, ORAL Cipramil (Citalopram) SS ORAL 40, ORAL Valproate (Valproate Sodium) SS ORAL 800 MG, DAILY Date:12/11/02ISR Number: 4024531-1Report Type:Expedited (15-DaCompany Report #EMADSS2002007539 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Risperdal Initial or Prolonged Cardiomegaly Health (Risperidone) PS ORAL SEE IMAGE, Professional ORAL 22-Feb-2006 08:20 AM Page: 1477 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/02ISR Number: 4024532-3Report Type:Expedited (15-DaCompany Report #EMADSS2002007514 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infection Foreign Risperdal Transient Ischaemic Health (Risperidone) PS ORAL ORAL Attack Professional Date:12/11/02ISR Number: 4024533-5Report Type:Expedited (15-DaCompany Report #NSADSS2002038690 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Aspiration Foreign Risperdal Literature (Risperidone) PS Health Professional Date:12/11/02ISR Number: 4024535-9Report Type:Expedited (15-DaCompany Report #APCDSS2002001520 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Ineffective Foreign Risperdal Myocardial Infarction Health (Risperidone) PS 10 MON Professional Company Representative Date:12/11/02ISR Number: 4024892-3Report Type:Expedited (15-DaCompany Report #2002-11-2655 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Consumer Clarinex Heart Rate Decreased Company (Desloratadine) Representative Tablets PS ORAL 5MG PRN ORAL Risperdal Tablets SS 0.75 QD Eskalith Capsules SS 450MG BID 2 YR Date:12/11/02ISR Number: 4025349-6Report Type:Expedited (15-DaCompany Report #NSADSS2002044216 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 0.25 MG, 1 IN 24 HOUR (S), ORAL Date:12/12/02ISR Number: 4023148-2Report Type:Direct Company Report #CTU 182643 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Risperidone PS 1 MG DAILY AT Intervention to BEDTIME Prevent Permanent Zoloft C Impairment/Damage 22-Feb-2006 08:20 AM Page: 1478 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/02ISR Number: 4026453-9Report Type:Expedited (15-DaCompany Report #02P-056-0205413-00 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Foreign Depakine Tablets Initial or Prolonged General Physical Health Health (Sodium Valproate) Deterioration Professional (Sodium Valproate) Hyponatraemia (Sodium Valproate) PS ORAL ORAL Psychomotor Skills Clonazepam SS ORAL ORAL Impaired Risperidone SS ORAL ORAL Aldactazine SS Date:12/13/02ISR Number: 4026536-3Report Type:Expedited (15-DaCompany Report #APCDSS2002001505 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nephrolithiasis Foreign Risperdal(Risperidon Health e) PS Professional Ritalin (Methylphenidate Hydrochloride) C Date:12/13/02ISR Number: 4027203-2Report Type:Expedited (15-DaCompany Report #02P-163-0205323-00 Age:50 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Colchicine Health (Colchicine) Professional (Colchicine) PS ORAL PER ORAL Oxycodone SS ORAL PER ORAL Risperidone SS ORAL PER ORAL Date:12/13/02ISR Number: 4027229-9Report Type:Expedited (15-DaCompany Report #NSADSS2002044453 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:12/13/02ISR Number: 4027596-6Report Type:Expedited (15-DaCompany Report #NSADSS2002037580 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death International Normalised Health Risperdal Ratio Increased Professional (Unspecified) (Risperidone) PS ORAL 1 MG, 2 IN DAILY, ORAL Date:12/16/02ISR Number: 4023972-6Report Type:Expedited (15-DaCompany Report #B0284890A Age:48 YR Gender:Male I/FU:F Outcome PT Hospitalization - Akinesia Initial or Prolonged Bradykinesia Disability Decreased Appetite Neuroleptic Malignant 22-Feb-2006 08:20 AM Page: 1479 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Report Source Product Role Manufacturer Route Dose Duration Health Paroxetine PS Glaxo Wellcome ORAL 20MG Per day Professional Chlorpromazine Hydrochloride SS Glaxo Wellcome ORAL 50MG per day Risperidone SS ORAL 6MG per day 12 DAY Nitrazepam C ORAL 10MG per day Date:12/16/02ISR Number: 4023986-6Report Type:Expedited (15-DaCompany Report #B0284890A Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Paroxetine PS Glaxo Wellcome ORAL 20MG Per day Initial or Prolonged Neuroleptic Malignant Chlorpromazine Disability Syndrome Hydrochloride SS Glaxo Wellcome ORAL 50MG per day Risperidone SS ORAL 6MG per day 12 DAY Nitrazepam C ORAL 10MG per day Date:12/16/02ISR Number: 4026160-2Report Type:Direct Company Report #CTU 182737 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperidone Tab 2mg (Janssen) PS Janssen ORAL 2MG PO BID Levothyroxine C Novolin 70/30 C Asa C Ascorbic Acid C Lactulose C Metoprolol C Mva C Kcl C Apap C Ntg Patch C Ntg Sl C Lorazepam C Clotrimazole C Furosemide C Trihexyphenidyl C Fe Gluconate C Date:12/16/02ISR Number: 4026855-0Report Type:Expedited (15-DaCompany Report #S02-GER-01443-01 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastritis Erosive Foreign Cipramil (Citalopram Initial or Prolonged Hepatic Cirrhosis Health Hydrobromide) PS ORAL 40 MG QD PO Other Hepatic Fibrosis Professional Risperdal Hepatic Steatosis Other (Risperidone) SS Hiatus Hernia Ergenyl Labaz Infection (Valproate Sodium) SS ORAL 800 MG QD PO Pyrexia White Blood Cell Count Increased 22-Feb-2006 08:20 AM Page: 1480 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/02ISR Number: 4026916-6Report Type:Expedited (15-DaCompany Report #NSADSS2002044455 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:12/16/02ISR Number: 4026917-8Report Type:Expedited (15-DaCompany Report #NSADSS2002044562 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Health Risperdal Other Hypoxia Professional (Unspecified) Leukopenia (Risperidone) PS ORAL 3 MG, 2 IN 1 Pneumonia DAY(S), ORAL Thrombocytopenia Lasix (Furosemide) C Potassium Chloride (Potassium Chloride) C Lorazepam (Lorazepam ) C Date:12/16/02ISR Number: 4027157-9Report Type:Expedited (15-DaCompany Report #326942 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Foreign Rivotril Initial or Prolonged General Physical Health Health (Clonazepam) PS ORAL ORAL Deterioration Professional Aldactazine Hyponatraemia (Althiazide / Spironolactone) SS ORAL ORAL Risperdal (Risperidone) SS ORAL ORAL Depakine (Valproate Sodium) SS ORAL ORAL Date:12/17/02ISR Number: 4027966-6Report Type:Expedited (15-DaCompany Report #2002070421 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Consumer Neurontin Life-Threatening Deterioration (Gabapentin) PS Other Medication Error Lamotrigine SS Respiratory Failure Risperidone SS All Other Therapeutic Products SS Date:12/17/02ISR Number: 4028231-3Report Type:Expedited (15-DaCompany Report #A044-002-004047 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Conduction Disorder Foreign Aricept (Donepezil) PS ORAL 10 MG, 1 IN 1 Initial or Prolonged Delirium Health D, PER ORAL Diarrhoea Professional Risperidone Electrocardiogram Qt (Risperidone) SS ORAL 0.5 MG, 1 IN Prolonged 1 D, PER ORAL Nuseals Aspirin (Acetylsalicylic Acid) C 22-Feb-2006 08:20 AM Page: 1481 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Losec (Omeprazole) C Duphalac (Lactulose) C Metoprolol (Metoprolol) C Date:12/17/02ISR Number: 4028495-6Report Type:Expedited (15-DaCompany Report #APCDSS2002001459 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperdal (Tablet) Initial or Prolonged Anxiety Health (Risperidone) PS ORAL 4 MG, DAILY, Delusional Disorder, Professional ORAL Erotomanic Type Biperiden Gastritis Atrophic Hydrochloride Medication Error (Biperiden Nausea Hydrochloride) C Overdose Nitrazepam Stress (Nitrazepam) C Thought Broadcasting Sennoside Vomiting (Sennoside) C Lansoprazole (Lansoprazole) C Mosapride Citrate (Mosapride) C Domperidone (Tablet) (Domperidone) C Date:12/17/02ISR Number: 4028525-1Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperdal (Tablet) Initial or Prolonged Blood Creatine Health (Risperidone) PS ORAL MG, DAILY, Phosphokinase Increased Professional ORAL Blood Pressure Increased Haldol (Tablet) Condition Aggravated (Haloperidol) SS ORAL MG, DAILY, Delusion ORAL Diabetes Mellitus Quetiapine Fumarate Hallucination (Quetiapine Hypoventilation Fumarate) SS ORAL MG, DAILY, Insomnia ORAL Respiratory Distress Hydroxyzine Pamoate Schizophrenia (Hydroxyzine) C Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:12/17/02ISR Number: 4028527-5Report Type:Expedited (15-DaCompany Report #EMADSS2002007610 Age: Gender:Female I/FU:I Outcome PT Report Source Other Leukopenia Foreign Health 22-Feb-2006 08:20 AM Page: 1482 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Product Role Manufacturer Route Dose Duration Risperdal (Unspecified) (Risperidone) PS ORAL 4 MG, DAILY, ORAL Date:12/17/02ISR Number: 4029052-8Report Type:Expedited (15-DaCompany Report #02P-056-0205510-00 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Depakine (Depakene) Initial or Prolonged Syndrome Health (Sodium Professional Valproate/Valproic Acid) (Sodium Valproate/Valproic PS PER ORAL Clobazam SS ORAL PER ORAL Risperidone SS ORAL PER ORAL Date:12/17/02ISR Number: 4029065-6Report Type:Expedited (15-DaCompany Report #EMADSS2002005732 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Risperdal Initial or Prolonged Shock Health (Unspecified) Professional (Risperidone) PS ORAL 2 MG, DAILY, ORAL Date:12/17/02ISR Number: 4029067-XReport Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Haldol (Tablet) Initial or Prolonged Blood Creatine Health (Haloperidol) PS ORAL MG, DAILY, Phosphokinase Increased Professional ORAL Blood Pressure Increased Risperdal (Tablet) Condition Aggravated (Risperidone) SS ORAL MG, DAILY, Delusion ORAL Diabetes Mellitus Quetiapine Fumarate Hallucination (Quetiapine Insomnia Fumarate) SS ORAL MG, DAILY, Respiratory Distress ORAL Hydroxyzine Pamoate (Hydroxyzine) C Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1483 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/02ISR Number: 4025728-7Report Type:Direct Company Report #CTU 183009 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Risperdal 1mg Jannsa PS Jannson SEE DESCRIBE EVENT Zyprexa 20mg Lilly SS Lilly SEE DESCRIBE EVENT Lithum 300mg Roche SS Roche Paxil C Synthroid C Lopid C Benadryl C Metamucil C Cogentin C Ativan C Prolixin C Altace C Date:12/18/02ISR Number: 4029141-8Report Type:Expedited (15-DaCompany Report #NSADSS2002045332 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Risperdal (1 Mg Sepsis Professional Tablet)(Risperidone) PS ORAL 1 MG, ORAL Date:12/18/02ISR Number: 4029143-1Report Type:Expedited (15-DaCompany Report #NSADSS2002045335 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Hospitalization - Professional Tablet)(Risperidone) PS ORAL 2 MG, 2 IN 1 Initial or Prolonged DAY(S), ORAL Date:12/18/02ISR Number: 4029146-7Report Type:Expedited (15-DaCompany Report #NSADSS2002045360 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Consumer Risperdal(1 Mg Tablet)(Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Date:12/18/02ISR Number: 4029490-3Report Type:Expedited (15-DaCompany Report #A213712 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Geodon (Ziprasidone) PS 40 MG BID Initial or Prolonged Electrocardiogram Qt Professional Luvox (Fluvoxamine Prolonged Maleate) SS 150 MG (BID) Risperidone SS 80 MG (TWICE A DAY) Clonazepam C Docusate C Benzatropine C Valproate Sodium C Oxybutynin C 22-Feb-2006 08:20 AM Page: 1484 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/18/02ISR Number: 4029553-2Report Type:Expedited (15-DaCompany Report #APCDSS2002001120 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Risperdal Initial or Prolonged Drug Screen Positive Health (Unspecified) Metabolic Disorder Professional (Risperidone) PS 0.5 & 1 & 2 Overdose Company MG, 2 IN 1 Respiratory Disorder Representative DAY(S), UNKNOWN Codeine (Codeine) C Lorazepam (Lorazepam) C Date:12/18/02ISR Number: 4029558-1Report Type:Expedited (15-DaCompany Report #APCDSS2002000517 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Risperdal (Tablet) Increased Health (Risperidone) PS ORAL ORAL Apathy Professional Aspartate Aminotransferase Increased Back Pain Blood Cholesterol Increased Blood Prolactin Increased Blood Triglycerides Increased Cardiomegaly Depressed Level Of Consciousness Diarrhoea Eye Pain Folliculitis Gamma-Glutamyltransferase Increased Gastroenteritis Insomnia Lipids Increased Nausea Date:12/19/02ISR Number: 4030199-0Report Type:Expedited (15-DaCompany Report #FR9375116DEC2002 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Temesta (Lorazepam, Initial or Prolonged Overdose Health Tablet, 0) PS ORAL 170 MG 1X PER Professional 1 DAY 1 DAY Depamide (Valpromide, , 0) SS 1 DAY Effexor (Venlafaxine Hydrochloride, Tablet, 0) SS ORAL 2.37 G 1X PER 1 DAY 1 DAY Parkinane Lp (Trihexyphenidyl, Capsule, Sustained Release, 0) SS ORAL 50 MG 1X PER 22-Feb-2006 08:20 AM Page: 1485 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 DAY 1 DAY Risperdal (Risperidone, ,0) SS 1 DAY Rivotril (Clonazepam, , 0) SS 1 DAY Theralene (Alimemazine Tartrate, , 0) SS ORAL 30 ML 1X PER 1 DAY 1 DAY Topiramate (Topiramate, , 0) SS 1 DAY Tranxene (Clorazepate Dipotassium, , 0) SS ORAL 500 MG 1X PER 1 DAY 1 DAY Zyprexa (Olanzapine, , 0) SS ORAL 140 MG 1X PER 1 DAY 1 DAY Date:12/20/02ISR Number: 4030736-6Report Type:Expedited (15-DaCompany Report #APCDSS2002001565 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Mass Foreign Risperdal Hospitalization - Circulatory Collapse Health (Unspecified) Initial or Prolonged Depressed Level Of Professional (Risperidone) PS ORAL ORAL Consciousness Fluvoxamine Maleate Overdose (Fluvoxamine Suicide Attempt Maleate) SS Toxicologic Test Abnormal Biperiden Hydrochloride (Biperiden Hydrochloride) SS Vegetamin A (Vegetamin A) SS Flunitrazepam (Flunitrazepam) SS Date:12/20/02ISR Number: 4030739-1Report Type:Expedited (15-DaCompany Report #APCDSS2002001569 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Malaise Foreign Risperidone Hospitalization - Respiratory Depression Health (Unspecified) Initial or Prolonged Professional (Risperidone) PS ORAL SEE IMAGE Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Date:12/20/02ISR Number: 4030741-XReport Type:Expedited (15-DaCompany Report #EMADSS2002006748 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 1.5 MG, DAILY, ORAL Loperamide 22-Feb-2006 08:20 AM Page: 1486 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Loperamide) C Fluoxetine (Fluoxetine) C Atenolol (Atenolol) C Enalapril (Enalapril) C Salicylic Acid (Salicylic Acid) C Piroxicam (Piroxicam) C Date:12/20/02ISR Number: 4030876-1Report Type:Expedited (15-DaCompany Report #2002056813 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Geodon (Ziprasidone Initial or Prolonged Agitation Professional Hydrochloride) PS 60 MG (BID) Other Anger Risperdal Hostility (Risperidone) SS ORAL 6 MG (DAILY), ORAL Zestril (Lisinopril) SS 10 MG (DAILY) Lorzepam C Date:12/20/02ISR Number: 4030930-4Report Type:Expedited (15-DaCompany Report #NSADSS2002045681 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:12/23/02ISR Number: 4032199-3Report Type:Expedited (15-DaCompany Report #2002071040 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Foreign Zoloft (Sertraline) PS ORAL 200 MG, ORAL Initial or Prolonged Fall Health Haldol (Haloperidol) SS 6 MG (DAILY) Other Gait Disturbance Professional Risperdal Salivary Hypersecretion (Risperidone) SS 4 MG, ORAL Trimipramine Maleate C Amlodipine Besilate C Diazepam C Date:12/23/02ISR Number: 4033171-XReport Type:Expedited (15-DaCompany Report #NSADSS2002036936 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:12/23/02ISR Number: 4033173-3Report Type:Expedited (15-DaCompany Report #NSADSS2002045684 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) 22-Feb-2006 08:20 AM Page: 1487 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) PS ORAL ORAL Date:12/24/02ISR Number: 4033485-3Report Type:Expedited (15-DaCompany Report #APCDSS2002001569 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Risperidone Hospitalization - Hypoxia Health (Unspecified) Initial or Prolonged Respiratory Depression Professional (Risperidone) PS 3 MG, SEE IMAGE Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Date:12/24/02ISR Number: 4033487-7Report Type:Expedited (15-DaCompany Report #EMADSS2002007869 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperidone Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG, DAILY, ORAL Co-Triamterzide (Dyazide) C Carbimazole (Carbimazole) C Kalms (Kalms) C Nytol (Nytol) C Welldorm (Dichloralphenazone) C Date:12/24/02ISR Number: 4033490-7Report Type:Expedited (15-DaCompany Report #EMADSS2002007878 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal (Tablet) Erythropenia Health (Risperidone) PS ORAL MG, DAILY, Leukopenia Professional ORAL Date:12/24/02ISR Number: 4033563-9Report Type:Expedited (15-DaCompany Report #S00-GER-01905-01 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Foreign Cipramil Initial or Prolonged Health (Citalopram) PS ORAL 20 MG QD PO Disability Professional Cipramil Other (Citalopram) SS ORAL 30 MG QD PO Cipramil (Citalopram) SS ORAL 40 MG QD PO Cipramil (Citalopram) SS ORAL 20 MG QD PO Cipramil (Citalopram) SS ORAL 40 MG QD PO Cipramil (Citalopram) SS ORAL 60 MG QD PO Fluanxol "Lundbeck" (Flupentixol 22-Feb-2006 08:20 AM Page: 1488 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dihydrochloride) SS ORAL 20 MG QD PO Fluanxol "Lundbeck"(Flupentix ol Dihydrochloride) SS ORAL 30 MG QD PO Fluanzol "Lundbeck" (Flupentixol Dihydrochloride) SS ORAL 25 MG QD PO Risperdal (Risperidone) SS 2 MG QD Risperdal (Risperidone) SS 4 MG QD Risperdal (Risperidone) SS 6 MG QD Risperdal (Risperidone) SS 4 MG QD Risperdal(Risperidon e) SS 3 MG QD Risperdal (Risperidone) SS 2 MG QD Haldol(Haloperidol) SS 5 MG QD Haldol(Haloperidol) SS 10 MG QD Haldol(Haloperidol) SS 5 MG QD Haldol(Haloperidol) SS 3 MG QD Haldol(Haloperidol) SS 10 MG QD Haldol(Haloperidol) SS 12.5 MG QD Haldol(Haloperidol) SS 10 MG QD Haldol (Haloperidol) SS 5 MG QD Akineton(Biperiden Hydrochloride) C Trevilor(Venlafaxine Hydrochloride) C Date:12/24/02ISR Number: 4033723-7Report Type:Expedited (15-DaCompany Report #NSADSS2002046241 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:12/24/02ISR Number: 4033886-3Report Type:Expedited (15-DaCompany Report #NSADSS2002046249 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 1 MG, 2 IN DAILY, ORAL Date:12/24/02ISR Number: 4033906-6Report Type:Expedited (15-DaCompany Report #NSADSS2002045685 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1489 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/02ISR Number: 4031805-7Report Type:Periodic Company Report #NSADSS2002033954 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Consumer Reminyl (Tablet) Agitation (Galantamine) PS ORAL 8 MG, 2 IN 1 Tremor DAY (S), ORAL Risperdal (1 Mg Tablet) (Risperidone) SS ORAL 1 MG, 1 IN 1 NIGHT (S), ORAL Sleeping Pill (Unspecified) C Date:12/26/02ISR Number: 4031877-XReport Type:Periodic Company Report #NSADSS2002036308 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Chills Consumer Reminyl Dystonia (Tablet)(Galantamine Fall ) PS ORAL 2 TABLE, 2 IN Purpura 4 HOUR(S), Therapeutic Response ORAL Decreased Risperdal (Unspecified )(Risperidone) SS ORAL ORAL Ativan (Lorazepam) C Vitamins (Vitamins) C Colace (Docusate Sodium) C Depakote (Valproate Semisodium) C Date:12/26/02ISR Number: 4034622-7Report Type:Expedited (15-DaCompany Report #S02-GER-01443-01 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastritis Erosive Foreign Cipramil (Citalopram Initial or Prolonged Hepatic Cirrhosis Health Hydrobromide) PS Other Hepatic Fibrosis Professional Futuril (Citalopram) SS ORAL 40 MG QD PO Hepatic Steatosis Other Ripserdal Hiatus Hernia (Risperidone) SS Infection Ergenyl "Labaz" Pyrexia (Valproate Sodium SS ORAL 800 MG QD PO White Blood Cell Count Increased Date:12/26/02ISR Number: 4034690-2Report Type:Expedited (15-DaCompany Report #FLUV00302002315 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Depromel 25 Condition Aggravated Health (Fluvoxamine Hypoxic Encephalopathy Professional Maleate) PS ORAL 25 MG DAILY Injury Asphyxiation Other PO Obsessive-Compulsive Risperdal Disorder (Risperidone) SS ORAL 6 MG DAILY PO Amoban (Zopiclone) C 22-Feb-2006 08:20 AM Page: 1490 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Minzain (Triazolam) C Rohypnol (Flunitrazepam) C Zantac (Ranitidine Hydrochloride) C Nozlen (Sodium Gualenate) C Date:12/27/02ISR Number: 4035645-4Report Type:Expedited (15-DaCompany Report #EMADSS2002007923 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Choking Foreign Risperdal Initial or Prolonged Drug Ineffective Health (Unspecified) Parkinson'S Disease Professional (Risperidone) PS 3 MG Pseudobulbar Palsy Cilazapril Vomiting (Cilazapril) C Pridinol (Pridinol) C Date:12/27/02ISR Number: 4035647-8Report Type:Expedited (15-DaCompany Report #EMADSS2002005277 Age:70 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemoglobin Decreased Foreign Risperdal (Tablet) Initial or Prolonged Oedema Peripheral Health (Risperidone) PS ORAL 1 MG, 2 IN 1 Professional DAY (S), ORAL Neurocil (Levomepromazine Maleate) C Date:12/27/02ISR Number: 4035649-1Report Type:Expedited (15-DaCompany Report #APCDSS2002001248 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperidone (Tablet) Health (Risperidone) PS ORAL ORAL Professional Haloperidol (Haloperidol) SS ORAL ORAL Sodium Valproate (Valproate Sodium) SS ORAL ORAL Paroxetine Hydrochloride Hydrate (Paroxetine Hydrochloride) C Lithium Carbonate (Lithium Carbonate) C Date:12/27/02ISR Number: 4035729-0Report Type:Expedited (15-DaCompany Report #APCDSS2002001248 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Haloperidol Health (Haloperidol) PS ORAL ORAL Professional Risperidone SS ORAL ORAL Sodium Valproate (Valproate Sodium) SS ORAL ORAL Paroxetine 22-Feb-2006 08:20 AM Page: 1491 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride Hydrate C Lithium Carbonate C Date:12/30/02ISR Number: 4032760-6Report Type:Direct Company Report #CTU 183516 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nightmare Risperidone PS ORAL 1 PO HS Initial or Prolonged Date:12/30/02ISR Number: 4034419-8Report Type:Expedited (15-DaCompany Report #02P-056-0205510-00 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Depakine (Depakene) Initial or Prolonged Phosphokinase Increased Health (Sodium Neuroleptic Malignant Professional Valproate/Valproic Syndrome Acid) (Sodium Valproate/Valproic PS ORAL PER ORAL Clobazam SS ORAL PER ORAL Risperidone SS ORAL PER ORAL Date:12/30/02ISR Number: 4035726-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE04203 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Tegretal Retard Apathy Consumer (Carbamazepine ) Disinhibition Other Extended Release Emotional Disorder Tablet PS ORAL ORAL Flat Affect Trevilor Impulse-Control Disorder (Venlafaxine Memory Impairment Hydrochloride) SS ORAL ORAL Personality Change Risperdal Thinking Abnormal (Risperidone) SS ORAL ORAL Visual Disturbance Date:12/30/02ISR Number: 4035875-1Report Type:Expedited (15-DaCompany Report #D0039992A Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Foreign Paxil (Formulation Initial or Prolonged Drug Interaction Health Unknown) (Paroxetine Potentiation Professional Hydrochloride) PS ORAL ORAL Dystonia Risperidone Posture Abnormal (Formulation Unknown) (Risperidone) SS ORAL SEE DOSAGE TEXT / ORAL Pipamperone (Formulation Unknown) (Pipamperone) SS ORAL SEE DOSAGE TEXT / ORAL Diazepam C Lorazepam C Aspirin C 22-Feb-2006 08:20 AM Page: 1492 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lactulose C Date:12/30/02ISR Number: 4036051-9Report Type:Expedited (15-DaCompany Report #NSADSS2002046469 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 24 HOUR(S), ORAL Date:12/30/02ISR Number: 4036052-0Report Type:Expedited (15-DaCompany Report #NSADSS2002046625 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:12/30/02ISR Number: 4036062-3Report Type:Expedited (15-DaCompany Report #EMADSS2002007919 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Risperdal Initial or Prolonged Drug Level Increased Health (Unspecified) Lung Infection Professional (Risperidone) PS ORAL 6 MG, DAILY, ORAL Date:12/30/02ISR Number: 4036063-5Report Type:Expedited (15-DaCompany Report #EMADSS2002007546 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Risperdal Complications Of Maternal Health (Unspecified) Exposure To Therapeutic Professional (Risperidone) PS ORAL 2 IN 1 DAILY, Drugs ORAL Maternal Drugs Affecting Seropram (Citalopram Foetus Hydrobromide) SS ORAL 20 MG, 2 IN 1 DAY (S), ORAL Date:12/30/02ISR Number: 4036065-9Report Type:Expedited (15-DaCompany Report #EMADSS2002007059 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Erectile Dysfunction Health (Unspecified) Disability Post Procedural Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 Required Complication TIME (S), Intervention to Priapism ORAL Prevent Permanent Methylphenidate Impairment/Damage (Methylphenidate) SS ORAL 30 MG, DAILY, ORAL Clonidine (Clonidine) C 22-Feb-2006 08:20 AM Page: 1493 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/02ISR Number: 4036067-2Report Type:Expedited (15-DaCompany Report #APCDSS2002001588 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Risperidone Complications Of Maternal Health (Unspecified) Exposure To Therapeutic Professional (Risperidone) PS ORAL 1 MG, 3 IN 1 Drugs DAILY, ORAL Maternal Drugs Affecting Folic Acid (Folic Foetus Acid) C Sertraline (Sertraline) C Alprazolam (Alprazolam) C Propranolol (Propranolol) C Date:12/31/02ISR Number: 4037869-9Report Type:Expedited (15-DaCompany Report #APCDSS2002001569 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Foreign Risperidone (Tablet) Hospitalization - Blood Pressure Increased Health (Risperidone) PS ORAL 3 MG; 2MG; Initial or Prolonged Depressed Level Of Professional 1 MG, DAILY, Consciousness ORAL Mitral Valve Incompetence Trihexyphenidyl Respiratory Acidosis Hydrochloride Respiratory Depression (Trihexyphenidyl Respiratory Failure Hydrochloride) C Somnolence Date:12/31/02ISR Number: 4037870-5Report Type:Expedited (15-DaCompany Report #NSADSS2002047361 Age:97 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, DAILY, ORAL Date:12/31/02ISR Number: 4037871-7Report Type:Expedited (15-DaCompany Report #APCDSS2002001421 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Risperdal Condition Aggravated Health (Unspecified) Neutropenia Professional (Risperidone) PS ORAL 4 MG, Viral Infection NIGHT(S), ORAL Date:01/02/03ISR Number: 4038367-9Report Type:Expedited (15-DaCompany Report #NSADSS2002047580 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1494 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/02/03ISR Number: 4038583-6Report Type:Expedited (15-DaCompany Report #EMADSS2002007985 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Foreign Reminyl Initial or Prolonged Health (Tablet)(Galantamine Professional ) PS 4 MG, DAILY, Risperdal (1 Mg Table)(Risperdone) SS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Date:01/02/03ISR Number: 4038686-6Report Type:Expedited (15-DaCompany Report #EMADSS2002005732 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Risperdal Initial or Prolonged Shock Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG DAILY Other ORAL Date:01/03/03ISR Number: 4038824-5Report Type:Expedited (15-DaCompany Report #EMADSS2002007735 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Risperidone(1 Mg Initial or Prolonged Hallucination Health Tablet) Hallucination, Visual Professional (Risperidone) PS ORAL 1 MG, DAILY, Company ORAL Representative Reminyl (Tablet) (Galantamine) SS ORAL 8 MG, DAILY, ORAL; 12 MG DAILY, ORAL Acebutolol (Acebutolol) C Vivalan (Viloxazine Hydrochloride) C Atarax (Hydroxyzine Hydrochloride) C Date:01/03/03ISR Number: 4038825-7Report Type:Expedited (15-DaCompany Report #EMADSS2002008027 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal(Unspecifie Health d) (Risperidone) PS 4 MG, DAILY Professional Venlafaxine (Venlafaxine) C Date:01/03/03ISR Number: 4039203-7Report Type:Expedited (15-DaCompany Report #NSADSS2002042702 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (4 Mg Health Tablet) Professional (Risperidone) PS ORAL 4 MG, 1 IN 4 DAY (S), ORAL 22-Feb-2006 08:20 AM Page: 1495 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/03ISR Number: 4039204-9Report Type:Expedited (15-DaCompany Report #NSADSS2002047739 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:01/06/03ISR Number: 4039936-2Report Type:Expedited (15-DaCompany Report #AMANTADI2002-00448 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Amantadine Unk Endo PS ORAL PO Convulsion Health Risperidone SS ORAL PO Lethargy Professional Miosis Suicide Attempt Urinary Incontinence Ventricular Fibrillation Date:01/06/03ISR Number: 4039957-XReport Type:Expedited (15-DaCompany Report #NSADSS2003000065 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:01/06/03ISR Number: 4039962-3Report Type:Expedited (15-DaCompany Report #NSADSS2003000269 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 0.25 MG, 2 IN DAILY, ORAL Date:01/08/03ISR Number: 4040620-XReport Type:Expedited (15-DaCompany Report #APCDSS2002001569 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Risperidone (Tablet) Hospitalization - Arrhythmia Health (Risperidone) PS ORAL 3 MG, SEE Initial or Prolonged Atrial Fibrillation Professional IMAGE Blood Pressure Systolic Trihexyphenidyl Increased Hydrochloride Depressed Level Of (Trihexypenidyl Consciousness Hydrochloride) C Malaise Mitral Valve Incompetence Respiratory Failure Somnolence 22-Feb-2006 08:20 AM Page: 1496 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/03ISR Number: 4040698-3Report Type:Expedited (15-DaCompany Report #NSADSS2003000639 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 2 MG, 1 IN 24 HOUR(S), ORAL Date:01/09/03ISR Number: 4040700-9Report Type:Expedited (15-DaCompany Report #NSADSS2003000644 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Varices Oesophageal Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:01/10/03ISR Number: 4040945-8Report Type:Expedited (15-DaCompany Report #NSADSS2003000895 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, 1 IN 1 NIGHT(S), ORAL Date:01/10/03ISR Number: 4041031-3Report Type:Expedited (15-DaCompany Report #NSADSS2003000900 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS ORAL 0.5 MG , 2 IN Professional 1 DAY(S), ORAL Date:01/10/03ISR Number: 4041042-8Report Type:Expedited (15-DaCompany Report #NSADSS2003000897 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (1 Mg Tablet) (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY (S), ORAL Date:01/12/03ISR Number: 4072053-4Report Type:Direct Company Report #USP 55466 Age:6 MON Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Convulsion Pediapred PS Celltech Dystonia Risperdal SS Janssen Pharm Lethargy Medication Error 22-Feb-2006 08:20 AM Page: 1497 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/03ISR Number: 4041852-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB03612 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Ritaline Initial or Prolonged Erectile Dysfunction Health (Methylphenidate Disability Priapism Professional Hydrochloride) Other Tablet PS ORAL 30 MG/DAY, ORAL Risperidone(Risperid one) SS ORAL ONCE/SINGLE, ORAL Clonidine (Clonidine) C Date:01/14/03ISR Number: 4042016-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB04324 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Dreams Foreign Clozaril Agitation Consumer (Clozapine) PS ORAL ORAL Alopecia Other Risperidone Arthralgia (Risperidone) SS 3 MG, BID, Chest Wall Pain Prozac (Fluoxetine Constipation Hydrochloride) SS 7.5 ML/DAY, Depression Diarrhoea Dizziness Dry Mouth Dyskinesia Dysuria Flushing Hepatocellular Damage Insomnia Memory Impairment Mouth Ulceration Movement Disorder Neuroleptic Malignant Syndrome Pain Palpitations Paraesthesia Photosensitivity Reaction Polyuria Pruritus Rash Restlessness Rhinorrhoea Shock Somnolence Speech Disorder Vision Blurred Weight Increased Date:01/14/03ISR Number: 4042273-3Report Type:Expedited (15-DaCompany Report #APCDSS2002001565 Age:37 YR Gender:Male I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:20 AM Page: 1498 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Chest X-Ray Abnormal Foreign Risperdal Circulatory Collapse Health (Resperidone) PS ORAL ORAL Depressed Level Of Professional Fluvoxamine Maleate Consciousness (Fluvoxamine Granuloma Maleate) SS ORAL ORAL Overdose Biperiden Suicide Attempt Hydrochloride Therapeutic Agent (Biperiden Toxicity Hydrochloride) SS ORAL ORAL Vegetamin A (Vegetamin A) SS ORAL ORAL Flunitrazepam (Flunitrazepam) SS ORAL ORAL Date:01/14/03ISR Number: 4042906-1Report Type:Expedited (15-DaCompany Report #NSADSS2003001109 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, DAILY, ORAL Zoloft (Sertraline Hydrochloride) C Date:01/16/03ISR Number: 4043651-9Report Type:Expedited (15-DaCompany Report #NSADSS2003001573 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Health Risperdal Professional (Risperidone) PS ORAL 4 MG, 1 IN 1 DAY (S), ORAL Date:01/16/03ISR Number: 4043652-0Report Type:Expedited (15-DaCompany Report #NSADSS2003001570 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Health Risperdal Professional (Risperidone) PS ORAL , DAILY, ORAL Date:01/16/03ISR Number: 4044084-1Report Type:Expedited (15-DaCompany Report #EMADSS2001006146 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cachexia Foreign Risperdal (3 Mg Initial or Prolonged Folate Deficiency Health Tablet) Normochromic Normocytic Professional (Risperidone) PS ORAL 3M G, 1 IN 1 Anaemia DAY (S), ORAL Tercian (Cyamemazine) SS ORAL 20 DROPS, 1 IN 1 DAY (S), ORAL 22-Feb-2006 08:20 AM Page: 1499 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/17/03ISR Number: 4044053-1Report Type:Expedited (15-DaCompany Report #NSADSS2003001563 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified)(Risper idone) PS Date:01/17/03ISR Number: 4044192-5Report Type:Expedited (15-DaCompany Report #NSADSS2003000884 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Embolic Stroke Foreign Risperdal Hospitalization - Hallucination Consumer (Unspecified)(Risper Initial or Prolonged idone) PS ORAL 1 MG, PRN, ORAL Seroquel (Seroquel) C Prednisone (Prednisone) C Eltroxin (Levothyroxine Sodium) C Metoprolol (Metoprolol ) C Flovent (Fluticasone Propionate) C Salbutamol (Salbutamol) C Atrovent (Ipratropium Bromide) C Nitro-Dur (Glyceryl Trinitrate) C Senokot (Senna Fruit) C Acetaminophen (Paracetamol) C Date:01/17/03ISR Number: 4044766-1Report Type:Expedited (15-DaCompany Report #EMADSS2003000119 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polyuria Foreign Risperdal (6mg Study Tablet) Health (Risperidone) PS ORAL 6 MG, 1 IN 1 Professional NIGHT(S), ORAL Diastabol (Miglitol) C Vandral (Venlafaxine Hydrochloriede) C Clotiapine (Clotiapine) C Date:01/17/03ISR Number: 4044788-0Report Type:Expedited (15-DaCompany Report #EMADSS2003000117 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Other Bronchospasm Foreign Study 22-Feb-2006 08:20 AM Page: 1500 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Product Role Manufacturer Route Dose Duration Risperidone (Tablet) (Risperidone) PS ORAL 3 MG, 1 IN 1 NIGHT(S), ORAL Date:01/17/03ISR Number: 4044832-0Report Type:Expedited (15-DaCompany Report #EMADSS2003000054 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperidone Study (Unspecified) Health (Risperidone) PS ORAL 2 MG, Professional DAILY,ORAL Date:01/21/03ISR Number: 4044035-XReport Type:Expedited (15-DaCompany Report #NSADSS2003001838 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Neoplasm Benign Consumer Risperdal(Unspecifie Initial or Prolonged d) (Risperidone) PS Date:01/21/03ISR Number: 4044374-2Report Type:Direct Company Report #CTU 184949 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatocellular Damage Risperidal PS 0.5MG BID Initial or Prolonged Jaundice Mirtazepin SS 30MG QHS Cyclosporin C Mycophenolate C Neomycin C Insulin C Date:01/21/03ISR Number: 4044696-5Report Type:Expedited (15-DaCompany Report #2003-DE-00014GD Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Lithium Carbonate Initial or Prolonged Bipolar Disorder (Lithium Carbonate) PS SEE IMAGE 3 MON Body Temperature Risperidone Increased (Risperidone) SS 3 MG NR Cognitive Disorder Paroxetine Constipation (Paroxetine) SS 20 MG NR Drug Interaction Olanzapine Drug Level Below (Antipsychotics) SS SEE IMAGE Therapeutic Benztropine Dry Mouth (Benzatropine Parkinsonian Crisis Mesilate) SS 2 MG Vision Blurred Nortriptyline (Nortriptyline) SS 50 MG 22-Feb-2006 08:20 AM Page: 1501 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/03ISR Number: 4044814-9Report Type:Expedited (15-DaCompany Report #L02-USA-03743-18 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Citalopram Health (Citalopram Professional Hydrobromide) PS Risperidone SS Perphenazine SS Date:01/21/03ISR Number: 4044916-7Report Type:Expedited (15-DaCompany Report #NSADSS2003001808 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5, ORAL Date:01/21/03ISR Number: 4044917-9Report Type:Expedited (15-DaCompany Report #NSADSS2003002067 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Joint Surgery Health Risperdal (3 Mg Professional Tablet)(Risperidone) PS ORAL 3 MG, 1 IN 24 HOUR(S), ORAL Date:01/21/03ISR Number: 4044925-8Report Type:Expedited (15-DaCompany Report #NSADSS2002038538 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 DAILY; ORAL Risperdal (Tablet) (Risperidone) SS ORAL 3 MG, 1 IN 1 NIGHT(S); ORAL Date:01/21/03ISR Number: 4045415-9Report Type:Expedited (15-DaCompany Report #EMADSS2002007514 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Foreign Risperidone (Tablet) Gastroenteritis Health (Risperidone) PS ORAL SEE IMAGE Hemiparesis Professional Hepa-Merz (Ornithine Transient Ischaemic Aspartate) C Attack Pantozol (Pantoprazole Sodium) C Tegretal (Carbamazepine) C Eunerpan (Melperone Hydrochloride) C Lasix (Furosemide) C Kallnor (Potassium Chloride) C Ferro Sanol (Ferro Sanol) C 22-Feb-2006 08:20 AM Page: 1502 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/03ISR Number: 4045457-3Report Type:Expedited (15-DaCompany Report #NSADSS2003001055 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gastroenteritis Viral Study Risperidone Initial or Prolonged Ileus Paralytic Health (Unspecified) Sinus Tachycardia Professional (Risperidone) PS Small Intestinal Clozapine Obstruction (Clozapine) SS Depakote (Valproate Semisodium) C Klonopin (Clonzepam) C Lipitor (Atorvastatin) C Vasotec (Enalapril Maleate) C Neurontin (Gabapentin) C Zoloft (Sertraline Hydrochloride) C Trazodone (Trazodone) C Iron (Iron) C Multivitamins (Multivitamins) C Insulin 70/30 (Human Mixtard) C Colace (Docusate Sodium) C Date:01/21/03ISR Number: 4046127-8Report Type:Expedited (15-DaCompany Report #EMADSS2002001369 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Foreign Risperidone PS ORAL 6 MG, Speech Disorder Study NIGHT(S), Tremor Health ORAL Professional Anafranil (Clomipramine Hydrochloride) C Diazepam (Diazepam) C Date:01/21/03ISR Number: 4046130-8Report Type:Expedited (15-DaCompany Report #EMADSS2003000259 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Risperidone PS ORAL 6MG, 1 IN 1 Alanine Aminotransferase Study NIGHT(S), Increased Health ORAL Aspartate Professional Rivotril Aminotransferase (Clonazepam) C Increased Atrioventricular Block Blood Lactate Dehydrogenase Increased Completed Suicide Depression 22-Feb-2006 08:20 AM Page: 1503 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/03ISR Number: 4046125-4Report Type:Expedited (15-DaCompany Report #EMADSS2002001359 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coordination Abnormal Foreign Risperidone (Tablet) Dysarthria Study (Risperidone) PS ORAL 1.5 MG , Extrapyramidal Disorder Health DAILY, ORAL Somnolence Professional Alprazolam (Alprazolam) C Date:01/23/03ISR Number: 4046522-7Report Type:Expedited (15-DaCompany Report #EMADSS2003000372 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Medication Error Health (Risperidone) Professional (Unspecified) PS Heminevrin (Clomethiazole Edisilate) SS Date:01/23/03ISR Number: 4046524-0Report Type:Expedited (15-DaCompany Report #EMADSS2003000244 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhage Intracranial Study Risperidone (Tablet) Health (Risperidone) PS ORAL 3 MG, 2 IN 1 Professional DAY(S), ORAL Lorazepam (Lorazepam) C Loramet (Lormetazepam) C Adiro (Acetylsalicylic Acid) C Date:01/23/03ISR Number: 4046528-8Report Type:Expedited (15-DaCompany Report #EMADSS2003000326 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperidone (Tablet) Study (Risperidone) PS ORAL 6 MG, 2 IN 1 Health DAY(S), ORAL Professional Date:01/23/03ISR Number: 4046638-5Report Type:Expedited (15-DaCompany Report #NSADSS2003002066 Age:95 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (0.5 Mg Health Tablet) Professional (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAY (S), ORAL 22-Feb-2006 08:20 AM Page: 1504 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/03ISR Number: 4046690-7Report Type:Expedited (15-DaCompany Report #NSADSS2003002283 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 3 IN DAILY, ORAL Date:01/23/03ISR Number: 4046691-9Report Type:Expedited (15-DaCompany Report #NSADSS2003002253 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAY (S), ORAL Amiodarone (Amiodarone) C Lopressor (Metoprolol Tartrate) C Aggrenox (Asasantin) C Megace (Megestrol Acetate) C Prevacid (Lansoprazole) C Norvasc (Amlodipine Besilate) C Synthroid (Levothyroxine Sodium) C Nitro-Dur (Glyceryl Trinitrate) C Date:01/23/03ISR Number: 4046712-3Report Type:Expedited (15-DaCompany Report #2003UW00738 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Seroquel PS ORAL 400 MG BID PO Initial or Prolonged Cardio-Respiratory Arrest Professional Atenolol SS 75 MG BID Dehydration Risperdal SS 1 MG BID Hypotension Benazepril SS 10 MG HS Hydrochlorothiazide SS 50 MG DAILY Date:01/23/03ISR Number: 4046715-9Report Type:Expedited (15-DaCompany Report #2003UW00738 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Seroquel PS ORAL 400 MG BID PO Initial or Prolonged Cardio-Respiratory Arrest Professional Atenolol SS 75 MG BID Dehydration Risperdal SS 1 MG BID Hypotension Benazepril SS 10 MG HS Hydrochlorothiazide SS 50 MG DAILY 22-Feb-2006 08:20 AM Page: 1505 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/03ISR Number: 4046794-9Report Type:Expedited (15-DaCompany Report #EMADSS2002007919 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Risperdal (2 Mg Initial or Prolonged Drug Level Increased Health Tablet) Endocarditis Professional (Risperidone) PS ORAL 2 MG, 3 IN 1 Lung Infection DAY(S), ORAL Somnolence Flodil Lp (Felodipine) C Atacand (Candesartan Cilexetil) C Parkinane (Trihexyphenidyl Hydrochloride) C Date:01/24/03ISR Number: 4047599-5Report Type:Expedited (15-DaCompany Report #EMADSS2003000540 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Foreign Risperdal ( 6mg Health Tablet) Professional (Risperidone) PS ORAL 6 MG, ORAL 2 MON Date:01/24/03ISR Number: 4047600-9Report Type:Expedited (15-DaCompany Report #EMADSS2003000233 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperidone ( 3mg Study Tablet) Health (Risperidone) PS ORAL 3 MG, 1 IN 1 Professional DAY(S), ORAL Date:01/24/03ISR Number: 4047715-5Report Type:Expedited (15-DaCompany Report #EMADSS2003000348 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperidone (3 Mg Initial or Prolonged Drug Abuser Study Tablet) Drug Ineffective Health (Risperidone) PS ORAL 3 MG, 1 IN 1 Professional NIGHT(S), ORAL Triptazol (Amitriptyline Hydrochloride) C Sedotime (Ketazolam) C Date:01/24/03ISR Number: 4047717-9Report Type:Expedited (15-DaCompany Report #EMADSS2003000499 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemorrhage Foreign Risperdal (1 Mg Initial or Prolonged Vasculitis Necrotising Health Tablet) Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Glicazida (Gliclazide) C Diltiazem 22-Feb-2006 08:20 AM Page: 1506 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Diltiazem) C Acarbose (Acarbose) C Ramipril (Ramipril) C Date:01/24/03ISR Number: 4047719-2Report Type:Expedited (15-DaCompany Report #EMADSS200300517 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Risperdal Initial or Prolonged Fall Health (Unspecified) Loss Of Consciousness Professional (Risperidone) PS UNKNOWN SEE IMAGE Metastases To Meninges Deroxat (Paroxetine Pleural Effusion Hydrochloride) SS UNKNOWN 10 MG, DAILY, Rib Fracture UNKNOWN Sarcoma Temesta (Lorazepam) SS UNKNOWN 2 MG, DAILY, Suicide Attempt UNKNOWN Zyprexa (Olanzapine) SS UNKNOWN 10 MG, DAILY, UNKNOWN Date:01/24/03ISR Number: 4047721-0Report Type:Expedited (15-DaCompany Report #NSADSS2003002271 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Risperdal Initial or Prolonged Delusion Consumer (Unspecified) Fear Health (Risperidone) PS 0.75 MG AM ; Paranoia Professional 0.5 MG HS Social Avoidant Behaviour Ritalin Suspiciousness (Methylphenidate Treatment Noncompliance Hydrochloride) C Date:01/24/03ISR Number: 4047936-1Report Type:Expedited (15-DaCompany Report #NSADSS2003003109 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:01/24/03ISR Number: 4048238-XReport Type:Periodic Company Report #A001-002-005249 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Aricept (Donepezil) PS ORAL 5 MG, 1 IN 1 Hypotension Professional D, PER ORAL Loss Of Consciousness Risperdal (Risperidone) SS ORAL PER ORAL Celexa (Citalopram) SS ORAL PER ORAL Date:01/27/03ISR Number: 4048097-5Report Type:Expedited (15-DaCompany Report #S02-FRA-01975-01 Age:84 YR Gender:Female I/FU:F Outcome PT Hospitalization - Apraxia Initial or Prolonged Balance Disorder Difficulty In Walking Fall 22-Feb-2006 08:20 AM Page: 1507 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertonia Polyneuropathy Report Source Product Role Manufacturer Route Dose Duration Foreign Seropram (Citalopram Health Hydrobromide) PS ORAL 20 MG QD PO Professional Neurontin Other (Gabapentin) SS Galantamine SS ORAL 4 MG BID PO Risperdal (Risperidone) SS Bi-Tildiem (Diltiazem Hydrochloride) SS Colchimax C Aricept (Donepezil Hydrochloride) C Anafranil (Clomipramine Hydrochloride) C Corvasal (Molsidomine) C Nitriderm Tts (Glyceryl Trinitrate) C Hept-A-Mil (Heptaminol Hydrochloride) C Temesta (Lorazepam) C Imovane (Zopiclone) C Dafalgan (Paracetamol) C Kardegic (Acetylsalicylate Lysine) C Stablon (Tianeptine) C Date:01/27/03ISR Number: 4048099-9Report Type:Expedited (15-DaCompany Report #EMADSS2003000345 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Haldol Decanoate Extrapyramidal Disorder Health (Injection) Speech Disorder Professional (Haloperidol Decanoate) PS INTRAMUSCULAR 250 MG, 1 IN 28 DAY(S), IM 28 DAY Risperidone (Risperidone) SS ORAL 8 MG, DAILY, ORAL / SEE IMAGE Zyprexa (Olanzapine) C Date:01/27/03ISR Number: 4048100-2Report Type:Expedited (15-DaCompany Report #APCDSS2002001273 Age:36 YR Gender:Female I/FU:F Outcome PT Death Completed Suicide Disturbance In Attention Fatigue Hallucination, Auditory 22-Feb-2006 08:20 AM Page: 1508 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Malaise Muscle Rigidity Somnolence Report Source Product Role Manufacturer Route Dose Duration Treatment Noncompliance Foreign Haldol (Haloperidol) PS ORAL 18 M,G DIALY, Health ORAL / SEE Professional IMAGE Risperidone (Risperidone) SS ORAL 4 MG, DAILY, ORAL Trihexyphenidyl Hydrochloride(Trihex yphenidyl Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Chlorpromazine Hydrochloride (Chlorpromane Hydrochloride) C Date:01/27/03ISR Number: 4048584-XReport Type:Expedited (15-DaCompany Report #EMADSS2003000484 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Haldol (Unspecified) Initial or Prolonged Overdose Health (Haloperidol) PS ORAL 8 MG, DAILY, Required Professional ORAL; 20 Intervention to TABLE 1 IN 1 Prevent Permanent TIME(S) Impairment/Damage Risperdal (Unspecified) (Risperidone) SS ORAL SEE IMAGE, ORAL Akineton (Biperiden Hydrochloride) SS ORAL 4 MG, DAILY, ORAL; 80 TABLE, 1 IN 1 TIME(S), Tavor (Lorazepam) SS 10 MG, 1 IN 1 TIME(S), UNKNOWN Date:01/27/03ISR Number: 4048620-0Report Type:Expedited (15-DaCompany Report #EMADSS2002005362 Age:84 YR Gender:Female I/FU:F Outcome PT Hospitalization - Apraxia Initial or Prolonged Areflexia Cauda Equina Syndrome Cerebral Atrophy Dementia Fall Gait Disturbance Hypertonia Lacunar Infarction Pain In Extremity Paraesthesia 22-Feb-2006 08:20 AM Page: 1509 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Polyneuropathy Vulvovaginal Discomfort Report Source Product Role Manufacturer Route Dose Duration Foreign Reminyl (Tablet) Health (Galantamine) PS ORAL 8 MG, DAILY, Professional ORAL Risperdal (1 Mg Tablet) (Risperidone) SS ORAL 0.5 MG, DAILY, ORAL Neurontin (Gabapentin) SS ORAL 1000 MG, DAILY, ORAL Colchimax (Colchimax) SS ORAL 1 CAP, DAILY, ORAL Seropram (Citalopram Hydrobromide) SS ORAL 20 MG, DAILY, ORAL Bi-Tildiem (Diltiazem Hydrochloride) SS ORAL 180 MG, DAILY, ORAL Nitriderm Tts (Glyceryl Trinitrate) C Hept-A-Myl (Heptaminol Hydrochloride) C Temesta (Lorazepam) C Imovane (Zopiclone) C Dafalgan (Paracetamol) C Kardegic (Acetylsalicylate Lysine) C Date:01/27/03ISR Number: 4048622-4Report Type:Expedited (15-DaCompany Report #EMADSS2003000484 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Risperdal Initial or Prolonged Overdose Health (Unspecified) Required Professional (Risperidone) PS ORAL 8 & 20 MG, Intervention to DAILY, ORAL Prevent Permanent Haldol (Unspecified) Impairment/Damage (Haloperidol) SS ORAL 8 MG, DAILY, ORAL; 20 TABLE, 1 IN 1 TIME(S) Akineton (Biperiden Hydrochloride) SS ORAL 4 MG, DAILY, ORAL; 80 TABLE, 1 IN 1 TIME(S) Tavor (Lorazepam) SS 10 MG, 1 IN 1 TIME(S), UNKNOWN 22-Feb-2006 08:20 AM Page: 1510 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/27/03ISR Number: 4048624-8Report Type:Expedited (15-DaCompany Report #EMADSS2002005362 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apraxia Foreign Risperdal (1 Mg Initial or Prolonged Areflexia Health Tablet) Cauda Equina Syndrome Professional (Risperidone) PS ORAL 0.5 MG, Cerebral Atrophy DAILY, ORAL Dementia Reminyl (Tablet) Fall (Galantamine) SS ORAL 8 MG, DAILY, Gait Disturbance ORAL Hypertonia Neurontn Lacunar Infarction (Gabapentin) SS ORAL 1000 MG, Pain In Extremity DAILY, ORAL Paraesthesia Colchimax(Colchimax) SS ORAL 1 CAP, DAILY, Polyneuropathy ORAL Vulvovaginal Discomfort Seropram (Citalopram Hydrobromide) SS ORAL 20 MG, DAILY, ORAL Bi-Tildiem (Diltiazem Hydrochloride) SS ORAL 180 MG, DAILY, ORAL Nitriderm Tts (Glyceryl Trin-Nitrate) C Hept-A-Myl (Heptaminol Hydrochloride) C Temesta (Lorazepam) C Imovane (Zopiclone) C Dafalgan (Paracetamol) C Kardegic (Acetylsalicylate Lysine) C Date:01/28/03ISR Number: 4048799-0Report Type:Expedited (15-DaCompany Report #EMADSS2003000585 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Risperdal Initial or Prolonged Femur Fracture Health (Unspecified) Disability Professional (Risperidone) PS 0.5 MG Temesta (Lorazepam) C Aspirin (Acetylsalicylic Acid) C Date:01/28/03ISR Number: 4048801-6Report Type:Expedited (15-DaCompany Report #EMADSS2003000584 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Company Sodium Valproate Representative (Valproate Sodium) C 22-Feb-2006 08:20 AM Page: 1511 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/28/03ISR Number: 4048823-5Report Type:Expedited (15-DaCompany Report #M0064-2003 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Mirtazapine PS ORAL 30 MG ORAL Increased Professional Risperidone SS 4 MG 55 DAY Aspartate Venlafaxine Aminotransferase Hydrochloride C Increased Oxazepam C Gamma-Glutamyltransferase Dalmadorm C Increased Seroquel C Spironolactone C Date:01/28/03ISR Number: 4049514-7Report Type:Expedited (15-DaCompany Report #NSADSS2003003088 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Risperdal (1 Mg Pulmonary Disease Professional Tablet) (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY (S), ORAL Date:01/28/03ISR Number: 4049715-8Report Type:Expedited (15-DaCompany Report #NSADSS2003003041 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Risperdal (Tablet) Initial or Prolonged Delusion (Risperidone) PS 2 MG IN AM, 4 Hysterectomy MG IN PM Loss Of Consciousness Premarin (Estrogens Treatment Noncompliance Conjugated) C Prozac (Fluoxetine Hydrochloride) C Date:01/29/03ISR Number: 4048847-8Report Type:Direct Company Report #CTU 185521 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Brain Neoplasm Risperdal 3mg Hospitalization - Janssen PS Janssen Initial or Prolonged Date:01/29/03ISR Number: 4048968-XReport Type:Direct Company Report #CTU 185577 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Risperdal 2mg PS ORAL 2MG BID ORAL 17 DAY Tremor Haldol C Hctz C Bactrim Ds C Motrin C Atenolol C Lovastatin C Kcl C Ecasa C Enalapril C Clonidine C Nifedipine C 22-Feb-2006 08:20 AM Page: 1512 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Valproic Acid C Loxapine C Colace C Date:01/29/03ISR Number: 4050120-9Report Type:Expedited (15-DaCompany Report #NSADSS2003003602 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:01/30/03ISR Number: 4049510-XReport Type:Direct Company Report #CTU 185637 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Angioneurotic Oedema Risperidone PS ORAL 2MG BID PO Alprostadil C Testosterone Enth C Glyburide C Date:01/30/03ISR Number: 4049512-3Report Type:Direct Company Report #CTU 185639 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Risperidol 0.5mg Po Erythema Bid PS ORAL 0.5MG PO BID Face Oedema Plavix C Vantin C Zocor C Asa C Effexor C Sinemet 25/100 C Detrol C Ativan C Date:01/30/03ISR Number: 4049582-2Report Type:Direct Company Report #CTU 185612 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Risperidone 2mg Initial or Prolonged Tongue Oedema Janssen PS Janssen ORAL 2MG BID ORAL Ibuprofen C Benztropine C Hydroxyzine C Fluoxetine C Date:01/30/03ISR Number: 4050892-3Report Type:Expedited (15-DaCompany Report #EMADSS2003000751 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Foreign Risperdal (Tablet) Pneumonia Health (Risperdone) PS ORAL 0.5 MG, Professional DAILY, ORAL; 1 MG, DAILY, ORAL; 3 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1513 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pentoxifyllin (Pentoxifylline) C Euthyrox (Levothyroxine Sodium) C Unat (Torasemide Sodium) C Proscar (Finasteride) C Anafranil (Clomipramine Hydrochloride) C Aricept (Donepezil Hydrochloride) C Nitrendipin (Nitrendipine) C Date:01/30/03ISR Number: 4050923-0Report Type:Expedited (15-DaCompany Report #NSADSS2003003880 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 1 MG, 1 IN DAILY, ORAL Date:01/30/03ISR Number: 4050965-5Report Type:Expedited (15-DaCompany Report #NSADSS2002039749 Age:90 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Health Risperdal (1 Mg Pulmonary Disease Professional Tablet) Coronary Artery Disease (Risperidone) PS 0.5 MG, 1 IN Disease Progression 1 NIGHT (S) Aspirin (Acetylsalicylic Acid) C Tenormin (Atenolol0 C Ferrous Sulfate (Ferrous Sulfate) C K-Dur (Potassium Chloride) C Nitroglycerin (Glyceryl Trinitrate) C Aricept (Donepezil Hydrochloride) C Proventil (Salbutamol) C Vitamin E (Tocopherol) C Vitamin C (Ascorbic Acid) C Oxygen (Oxygen) C Minitran (Glyceryl Trinitrate) C Tiazac (Diltiazem Hydrochloride) C Albuterol (Salbutamol) C 22-Feb-2006 08:20 AM Page: 1514 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lasix (Furosemide) C Prednisone (Prednisone) C Roxanol (Morphine Sulfate) C Ativan (Lorazepam) C Date:01/30/03ISR Number: 4050967-9Report Type:Expedited (15-DaCompany Report #NSADSS2003003610 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Urinary Tract Consumer Risperdal (1 Mg Initial or Prolonged Neoplasm Tablet) Required Blood Prolactin Increased (Risperidone) PS ORAL 2 MG, 2 IN Intervention to Ejaculation Failure DAILY, ORAL Prevent Permanent Erectile Dysfunction Impairment/Damage Libido Decreased Pituitary Tumour Varicocele Date:01/31/03ISR Number: 4050814-5Report Type:Expedited (15-DaCompany Report #NSADSS2002046241 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Risperdal Congestive Professional (Risperidone) PS ORAL 4, DAILY, ORAL Clonazepam (Clonazepam) C Spironolactone (Spironolactone) C Phenobarbital (Phenobarbital) C Coenzyme Q 10 (Ubidecarenone) C Date:01/31/03ISR Number: 4050817-0Report Type:Expedited (15-DaCompany Report #NSADSS2003001838 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Meningioma Consumer Risperdal Initial or Prolonged (Risperidone) PS Date:02/03/03ISR Number: 4051430-1Report Type:Expedited (15-DaCompany Report #2003AP00121 Age:65 YR Gender:Female I/FU:F Outcome PT Death Alanine Aminotransferase Life-Threatening Increased Aspartate Aminotransferase Increased Blood Glucose Decreased Blood Lactate Dehydrogenase Increased Blood Pressure Decreased Blood Urea Increased 22-Feb-2006 08:20 AM Page: 1515 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Brain Oedema Convulsion Depressed Level Of Report Source Product Role Manufacturer Route Dose Duration Consciousness Foreign Seroquel PS ORAL 200 MG DAILY Disseminated Health PO Intravascular Coagulation Professional Risperdal SS ORAL 0.5 MG QID PO Dysphagia Other Akineton C Hepatic Function Abnormal Amoban C Pallor Rohypnol C Po2 Decreased Sennoside C Reye'S Syndrome Brovarin C Somnolence Date:02/03/03ISR Number: 4051441-6Report Type:Expedited (15-DaCompany Report #2003UW00738 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Seroquel PS ORAL 400 MG BID PO Initial or Prolonged Dehydration Professional Seroquel SS ORAL 500 MG BID PO Dizziness Atenolol SS 75 MG BID Hypotension Risperdal SS 1 MG BID Psychotic Disorder Benazepril SS 10 MG HS Restlessness Hydrochlorothiazide SS 50 MG DAILY Syncope Date:02/03/03ISR Number: 4051443-XReport Type:Expedited (15-DaCompany Report #2003002938 Age:38 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Norvasc (Amlodipine) PS ORAL ORAL Health Risperidone SS Professional Trihexyphenidyl SS Date:02/03/03ISR Number: 4051503-3Report Type:Expedited (15-DaCompany Report #NSADSS2003004003 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Study Risperidone Initial or Prolonged Road Traffic Accident Health (Unspecified) Professional (Risperidone) PS Clozapine (Clozapine) SS Hydroxyzine Pamoate C Zoxor (Simvastatin) C Food Supplements C Date:02/03/03ISR Number: 4051539-2Report Type:Expedited (15-DaCompany Report #2003-BP-00499RO Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Lithium Carbonate Initial or Prolonged Fall Health Capsules Usp, 300 Mg Professional (Lithium Carbonate) PS ORAL PO Other Tranxene (Clorazepate Dipotassium) SS ORAL 20 MG (10 MG, 2 IN 1 D), PO 22-Feb-2006 08:20 AM Page: 1516 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zolpidem (Zolpidem) SS ORAL 10 MG (10 MG, 1 IN 1 D), PO Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) SS ORAL 25 MG (25 MG, 1 IN 1 D), PO Risperidone (Risperidone) SS ORAL 1 MG (1 MG, 1 IN 1 D), PO Date:02/03/03ISR Number: 4051544-6Report Type:Expedited (15-DaCompany Report #EMADSS2003000580 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Foreign Risperidone Study (Unspecified) Health (Risperidone) PS ORAL SEE IMAGE, Professional ORAL Flusemide (Nicardipine Hydrochloride) C Nootropil (Piracetam) C Staticum (Glisentide) C Duphalac (Lactulose) C Distraneurine (Clomethiazole Edisilate) C Date:02/03/03ISR Number: 4051545-8Report Type:Expedited (15-DaCompany Report #EMADSS2003000601 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Pulmonary Oedema Foreign Risperidone Study (Unspecified) Health (Risperidone) PS 1 MG, 2 IN 1 Professional DAY(S) Dilitol (Buphenine Hydrochloride) C Minodiab (Glipizide) C Venoruton (Troxerutin) C Enalapril (Enalaparil) C Date:02/03/03ISR Number: 4051557-4Report Type:Expedited (15-DaCompany Report #EMADSS2003000765 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Foreign Risperdal White Blood Cell Count Health (Unspecified) Decreased Professional (Risperidone) PS Company Representative 22-Feb-2006 08:20 AM Page: 1517 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/03ISR Number: 4051558-6Report Type:Expedited (15-DaCompany Report #EMADSS2003000762 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Stenosis Foreign Risperidone Overdose Health (Unspecified) Sudden Death Professional (Risperidone) PS ORAL 12 MG, DAILY, ORAL 7 YR Nozinan (Levomepromazine) SS ORAL 100 MG, DAILY, ORAL 20 YR Date:02/03/03ISR Number: 4051559-8Report Type:Expedited (15-DaCompany Report #EMADSS2003000713 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Risperdal Initial or Prolonged Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Sotalex (Sotalol Hydrochloride) C Amlor (Amlodipine Besilate) C Buspar (Buspirone Hydrochloride) C Seropram (Citalopram Hydrobromide) C Aspegic (Acetylsalicylate Lysine) C Discotrine (Glyceryl Trinitrate) C Ditropan (Oxybutynin) C Date:02/03/03ISR Number: 4051561-6Report Type:Expedited (15-DaCompany Report #APCDSS2003000073 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Headache Foreign Risperidone Initial or Prolonged Hyperpyrexia Health (Unspecified) Infection Professional (Risperidone) PS Musculoskeletal Stiffness Date:02/03/03ISR Number: 4053321-9Report Type:Periodic Company Report #A0365365A Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Consumer Lamictal Unspecified Initial or Prolonged Loss Of Consciousness Tablet (Lamotrigine) PS ORAL SINGLE Overdose DOSE/ORAL Fluoxetine Hydrochloride Tablet (Fluoxetine Hydrochloride) SS ORAL SINGLE DOSE/ORAL Risperidone Tablet (Risperidone) SS ORAL SINGLEL 22-Feb-2006 08:20 AM Page: 1518 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DOSE/ORAL Paracetamol C Date:02/04/03ISR Number: 4052260-7Report Type:Expedited (15-DaCompany Report #2002056983 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apraxia Foreign Neurontin Initial or Prolonged Fall Health (Gabapentin) PS ORAL ORAL Other Gait Disturbance Professional Galantamine SS ORAL 8 MG (4 MG, Hypertonia TWICE DAILY), Polyneuropathy ORAL Colchimax SS ORAL (DAILY), ORAL Citalopram Hydrobromide SS ORAL 20 MG (DAILY), ORAL Risperidone SS ORAL 0.5 MG (DAILY), ORAL Diltiazem Hydrochloride SS ORAL 180 MG (90 MG, TWICE DAILY), ORAL Glyceryl Trinitrate C Heptaminol Hydrochloride C Lorazepam C Zopiclone C Paracetamol C Acetylsalicylate Lysine C Clomipramine Hydrochloride C Molsidomine C Donepezil Hydrochloride C Tianeptine C Date:02/04/03ISR Number: 4052313-3Report Type:Expedited (15-DaCompany Report #2003UW01191 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Elavil PS ORAL 25 MG QD PO Initial or Prolonged Fall Consumer Tranxene SS ORAL 10 MG BID PO Other Lithium Carbonate SS Risperidone SS ORAL 1 MG QD PO Zoldipem SS ORAL 10 MG QD PO Date:02/04/03ISR Number: 4052342-XReport Type:Direct Company Report #CTU 185943 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperidone PS 1.5MG Q AM, 2MG Q HS Valproic Acid C Chlorpromazine C Compound W Patch C Guaifenesin C Mylanta C Benzamycin Gel C 22-Feb-2006 08:20 AM Page: 1519 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/03ISR Number: 4052750-7Report Type:Expedited (15-DaCompany Report #NSADSS2003004762 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 20 MG, ORAL Date:02/04/03ISR Number: 4052751-9Report Type:Expedited (15-DaCompany Report #NSADSS2003004523 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Unspecified)(Risper idone) PS ORAL ORAL Date:02/04/03ISR Number: 4052870-7Report Type:Expedited (15-DaCompany Report #2003002870 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Consumer Zoloft(Sertraline) PS ORAL 200 MG Initial or Prolonged Blood Pressure Decreased (DAILY), ORAL Other Bronchitis Risperidone SS ORAL 3 MG (DAILY), Fall ORAL Forearm Fracture Quetiapine Fumarate SS ORAL ORAL Increased Appetite Fexofenadine Joint Sprain Hydrochloride C Loss Of Consciousness Desloratadine C Menorrhagia Atenolol C Pneumonia Aspiration Ibuprofen C Somnolence Suicide Attempt Weight Increased Date:02/04/03ISR Number: 4053084-7Report Type:Expedited (15-DaCompany Report #2003002870 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Consumer Zoloft (Sertraline) PS ORAL 200 MG Initial or Prolonged Bronchitis (DAILY), ORAL Other Fall Risperidone SS ORAL 3 MG (DAILY), Increased Appetite ORAL Intentional Overdose Quetiapine Fumarate SS ORAL ORAL Joint Sprain Ibuprofen SS ORAL ORAL Loss Of Consciousness Diphenhydramine Menorrhagia Hydrochloride SS ORAL ORAL Pneumonia Aspiration Fexofenadine Somnolence Hydrochloride C Suicide Attempt Desloratadine C Upper Limb Fracture Atenolol C Weight Increased Date:02/05/03ISR Number: 4051690-7Report Type:Direct Company Report #CTU 186051 Age: Gender:Male I/FU:I Outcome Required Intervention to Prevent Permanent 22-Feb-2006 08:20 AM Page: 1520 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Gynaecomastia Risperdal PS ORAL 1 MG PO BID Date:02/05/03ISR Number: 4053666-2Report Type:Expedited (15-DaCompany Report #FLUV00302002315 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Depromel 25 Hospitalization - Apathy Health (Fluvoxamine Initial or Prolonged Cardio-Respiratory Arrest Professional Maleate) PS ORAL SEE IMAGE, PO Circadian Rhythm Sleep Other Risperdal Disorder (Risperidone) SS ORAL SEE IMAGE, PO Hypochondriasis Vegetamin-B SS ORAL 1 MG DAILY PO Hypoxic Encephalopathy Amoban (Zopiclone) C Neurosis Minzain (Triazolam) C Obsessive-Compulsive Rohypnol Disorder (Flunitrazepam) C Sudden Death Zantac (Ranitidine Thinking Abnormal Hydrochloride) C Nozlen (Sodium Gualenate) C Noxtal (Brotizolam) C Horizon (Diazepam) C Date:02/05/03ISR Number: 4053908-3Report Type:Expedited (15-DaCompany Report #030127-PM0023-00 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Tranxene Initial or Prolonged Intentional Overdose Health (Clorazepate Professional Dipotassium) PS ORAL 500 MG, P.O, Other QD Valpromide SS Lorazepam SS ORAL 170 MG, P.O., QD Alimemazine Tartrate SS ORAL 15 MG, P.O., QD Clonazepam SS Risperidone SS Topiramate SS Olanzapine SS 140 MG, QD Trihexyphenidyl Hydrochloride SS 50 MG Venlafaxine Hydrochloride SS Date:02/07/03ISR Number: 4053968-XReport Type:Expedited (15-DaCompany Report #2003003729 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Lithane ( Lithium) PS ORAL ORAL Initial or Prolonged Fall Health Amitriptyline Professional Hydrochloride SS ORAL 25 MG (DAILY), ORAL Clorazepate Dipotassium SS ORAL 10 MG (BID), 22-Feb-2006 08:20 AM Page: 1521 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Zolpidem SS ORAL 10 MG (DAILY), ORAL Risperidone SS ORAL 1 MG (DAILY), ORAL Date:02/07/03ISR Number: 4054039-9Report Type:Expedited (15-DaCompany Report #NSADSS2003005182 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Consumer Risperdal (Tablet) (Risperidone) PS 0.5MG IN AM AND 3 MG AT BEDTIME Prednisone (Prednisone) C Toprol (Metoprolol) C Lasix (Furosemide) C Potassium (Potassium) C Trazodone (Trazodone) C Exalon C Date:02/07/03ISR Number: 4054104-6Report Type:Expedited (15-DaCompany Report #DEWYE007403FEB03 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Systolic Health Trevilor Initial or Prolonged Decreased Professional (Venlafaxine Bowel Sounds Abnormal Hydrochloride, Extensor Plantar Response Tablet, 0) PS ORAL 100 TABELTS Hypotonia (OVERDOSE Intentional Overdose AMOUNT Respiratory Failure 5000MG), ORAL 1 DAY Suicide Attempt Risperdal Tachycardia (Risperidone, 0) SS ORAL 50 TABLETS (OVERDOSE AMOUNT 50MG), ORAL 1 DAY Date:02/07/03ISR Number: 4054180-0Report Type:Expedited (15-DaCompany Report #EMADSS2002007426 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Insipidus Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Date:02/07/03ISR Number: 4054251-9Report Type:Expedited (15-DaCompany Report #EMADSS2003000701 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Pulmonary Oedema Foreign Risperidone Study (Unspecified) Health (Risperidone) PS ORAL 0.5 MG, Professional DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1522 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/03ISR Number: 4054252-0Report Type:Expedited (15-DaCompany Report #EMADSS2003000678 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperidone Study (Unspecified) Health (Risperidone) PS ORAL 1 MG, 1 IN 1 Professional DAY (S),ORAL Nimodipine (Nimodipine) C Date:02/07/03ISR Number: 4054253-2Report Type:Expedited (15-DaCompany Report #EMADSS2003000677 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperidone Study (Unspecified) Health (Risperidone) PS ORAL 1 MG, DAILY, Professional ORAL Date:02/07/03ISR Number: 4054254-4Report Type:Expedited (15-DaCompany Report #EMADSS2003000632 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperidone Study (Unspecified) Health (Risperidone) PS ORAL ORAL Professional Date:02/07/03ISR Number: 4054255-6Report Type:Expedited (15-DaCompany Report #APCDSS2003000110 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Foreign Risperidone Stupor Health (Unspecified) Professional Risperidone) PS ORAL 2 MG, DAILY, ORAL Haldol (Unspecified) (Haloperidol) SS Date:02/07/03ISR Number: 4054256-8Report Type:Expedited (15-DaCompany Report #EMADSS2003000924 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Risperdal (4 Mg Exposure To Therapeutic Health Tablet) Drugs Professional (Risperidone) PS ORAL 4 MG, 2 IN 1 Laboratory Test Abnormal Company DAY (S), ORAL Maternal Drugs Affecting Representative Largactil Foetus (Chlorpromazine) C Pregnancy Depamide (Valpromide) C 22-Feb-2006 08:20 AM Page: 1523 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/03ISR Number: 4054257-XReport Type:Expedited (15-DaCompany Report #APCDSS2002000428 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Chondrodystrophy Foreign Risperdal Complications Of Maternal Health (Risperidone) PS 4 MG, DAILY, Exposure To Therapeutic Professional UTERINE Drugs Carbamazepine Ear Malformation (Carbamazepine) C Maternal Drugs Affecting Trihexyphenidyl Foetus Hydrochloride Vacuum Extractor Delivery (Trihexyphenidyl Hydrochloride) C Date:02/07/03ISR Number: 4054308-2Report Type:Expedited (15-DaCompany Report #APCDSS2002001364 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Foreign Risperidone (Tablet) Hospitalization - Depressed Level Of Health (Risperidone) PS ORAL 4 MG, DAILY, Initial or Prolonged Consciousness Professional ORAL; 5 MG, Diabetes Mellitus DAILY, ORAL; Diabetic Hyperglycaemic 6 MG, DAILY, Coma ORAL; 5 MG, Drug Effect Decreased Milnacipran Fall Hydrochloride Hyperphagia (Milnacipran) SS ORAL 30 MG, DAILY, Major Depression ORAL; 40 MG, Nasopharyngitis DAILY, ORAL Nausea Levomepromazine Peripheral Coldness Maleate Urobilin Urine Present (Levomepromazine Maleate) C Date:02/07/03ISR Number: 4055120-0Report Type:Expedited (15-DaCompany Report #NSADSS2003005438 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Respiratory Arrest Health Risperdal Professional (Unspecified)(Risper done) PS 5 MG, DAILY, UNKNOWN Zyprexa (Olanzapine) SS ORAL 5 MG, DAILY, ORAL Date:02/07/03ISR Number: 4055121-2Report Type:Expedited (15-DaCompany Report #NSADSS2003005356 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Risperdal White Blood Cell Count Professional (Unspecified) Decreased (Risperidone) PS ORAL 1.5 MG, 24 HOUR(S), ORAL 22-Feb-2006 08:20 AM Page: 1524 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/03ISR Number: 4055122-4Report Type:Expedited (15-DaCompany Report #NSADSS2003004539 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Haemorrhagic Stroke Health Risperdal Other Pituitary Haemorrhage Professional (Unspecified) Pituitary Tumour Benign (Risperidone) PS ORAL ORAL Date:02/07/03ISR Number: 4055123-6Report Type:Expedited (15-DaCompany Report #NSADSS2003005076 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Study Risperdal Initial or Prolonged Mental Status Changes Health (Unspecified) Professional (Risperidone) PS 0.75 MG, DAILY Risperidone (Tablet) (Risperidone) SS ORAL 1.5 MG, DAILY, ORAL Placebo (Unspecified) (Placebo) SS ORAL 1.5 MG, DAILY, ORAL Accupril (Quinapril Hydrochloride) C Detrol (Tolterodine L-Tartrate) C Megace (Megestrol Acetate) C Pravachol (Pravastatin Sodium) C Vitamin B12(Cyanocobalamin) C Diclofenac (Diclofenac) C Ambien (Zolpidem Tartrate) C Multivitamins (Multivitamins) C Norvasc (Amlodipine Besilate) C Date:02/10/03ISR Number: 4055227-8Report Type:Expedited (15-DaCompany Report #FLUV00302002315 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Depromel 25 Hospitalization - Anxiety Health (Fluvoxamine Initial or Prolonged Cardio-Respiratory Arrest Professional Maleate) PS ORAL 25 MG DAILY Condition Aggravated Other PO, 100 MG Drug Eruption DAILY PO, 25 Drug Ineffective MG DAILY PO Hypochondriasis Risperdal Hypoxic Encephalopathy (Risperidone) SS ORAL 6 MG DAILY Injury Asphyxiation PO, 4 MG Obsessive-Compulsive DAILY PO Disorder Vegetamin-B () SS ORAL 1 MG DAILY PO Rash Amoban (Zopiclone) C Suicide Attempt Minzain (Triazolam) C Rohypnol 22-Feb-2006 08:20 AM Page: 1525 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Flunitrazepam) C Zantac (Ranitidine Hydrochloride) C Nozlen (Sodium Gualenate) C Noxtal (Brotizolam) C Horizon (Diazepam) C Date:02/11/03ISR Number: 4055950-5Report Type:Expedited (15-DaCompany Report #NSADSS2003005317 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Risperdal (0.5 Mg Initial or Prolonged Fall Tablet) Fatigue (Risperidone) PS ORAL SEE IMAGE, Head Injury ORAL Skin Discolouration Lipitor (Atorvastatin) C Protonix (Pantoprazole) C Calcium (Calcium) C Labetalol (Labetalol) C (Acetylsalicylic Acid) C Thyroid Meds (Thyroid Prep Unsp) C Date:02/11/03ISR Number: 4055951-7Report Type:Expedited (15-DaCompany Report #NSADSS2003000900 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastatic Neoplasm Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAY(S), ORAL Date:02/11/03ISR Number: 4055952-9Report Type:Expedited (15-DaCompany Report #NSADSS2002047361 Age:97 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Health Risperdal (0.5 Mg Required Complete Professional Tablet) Intervention to Cardiomyopathy (Risperidone) PS ORAL 0.5 MG, Prevent Permanent DAILY, ORAL Impairment/Damage Date:02/11/03ISR Number: 4056295-XReport Type:Expedited (15-DaCompany Report #2003003074 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Gabapentin Overdose Health (Gabapentin) PS ORAL ORAL Professional Risperidone SS ORAL ORAL Benzatropine Mesilate SS ORAL ORAL All Other 22-Feb-2006 08:20 AM Page: 1526 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Products SS ORAL ORAL Date:02/11/03ISR Number: 4056614-4Report Type:Expedited (15-DaCompany Report #APCDSS2002001248 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperidone (Tablet) Neuroleptic Malignant Health (Risperidone) PS ORAL ORAL Syndrome Professional Haloperidol(Haloperi dol) SS ORAL Sodium Valproate(Valproate Sodium) SS ORAL ORAL Paroxetine Hydrochloride Hydrate (Paroxetine Hydrochloride) C Lithium Carbonate(Lithium Carbonate) C Date:02/11/03ISR Number: 4056624-7Report Type:Expedited (15-DaCompany Report #APCDSS2002001248 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Haloperidol Neuroleptic Malignant Health (Haloperidol) PS ORAL ORAL Syndrome Professional Risperidone(Tablet)R isperidone SS ORAL ORAL Sodium Valproate(Valproate Sodium) SS ORAL ORAL Paroxetine Hydrochloride Hydrate(Paroxetine Hydrochloride) C Lithium Carbonate(Lithium Carbonate) C Date:02/11/03ISR Number: 4056693-4Report Type:Expedited (15-DaCompany Report #NSADSS2003005696 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Huntington'S Chorea Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 6 IN 24 HOUR(S), ORAL Effexor (Venlafaxine Hydrochloride) C Date:02/11/03ISR Number: 4056696-XReport Type:Expedited (15-DaCompany Report #NSADSS2002039888 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ankle Fracture Health Risperdal (0.5 Mg Fall Professional Tablet) 22-Feb-2006 08:20 AM Page: 1527 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) PS ORAL 1 IN 1 DAY(S), ORAL Ferrous Sulfate C Aspirin (Acetylsalicylic Acid) C Tylenol No 3 C Magnesium Oxide C Calcium C Fosamax (Alendronate Sodium) C Seroquel C Date:02/11/03ISR Number: 4056776-9Report Type:Expedited (15-DaCompany Report #EMADSS2003000972 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Risperdal Initial or Prolonged Health (Unspecified) Professional (Risperidone) PS ORAL 6 MG, DAILY, Company ORAL; 8 MD, Representative DAILY, ORAL Date:02/12/03ISR Number: 4057056-8Report Type:Expedited (15-DaCompany Report #EMADSS2003001125 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 2 MG, 3 IN 1 DAY(S), ORAL Nifedipine (Nifedipine) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Selegiline (Selegiline) C Date:02/12/03ISR Number: 4057228-2Report Type:Expedited (15-DaCompany Report #030130-PM0024-00 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Tranxene Initial or Prolonged Rhabdomyolysis Health (Clorazepate Suicide Attempt Professional Dipotassium) Tablets PS ORAL 5 MG, P.O QD Other Risperedone Tablets SS ORAL P.O. Olanzapine Tablets SS ORAL P.O. Lithium Carbonate Tablets SS ORAL P.O. Levomepromazine Tablets SS ORAL P.O. 22-Feb-2006 08:20 AM Page: 1528 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/12/03ISR Number: 4057238-5Report Type:Expedited (15-DaCompany Report #EMADSS2003001007 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Risperdal Initial or Prolonged Health (Unspecified) Professional (Risperdone) PS ORAL 9 MG, DAILY, ORAL Cloxacillin (Cloxacillin) SS Haloperidol (Haloperidol) C Chlorhydrate Levomepromazine (Levomepromazine Hydrochloride) C Chlorhydrate Taiprida (Tiapride) C Date:02/12/03ISR Number: 4057239-7Report Type:Expedited (15-DaCompany Report #APCDSS2003000151 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Risperidone Initial or Prolonged Health (Tablet)(Risperidone Professional ) PS ORAL 6 MG, DAILY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Candesartan Cilexetil (Candesartan Cilexetil) C Senna Extract (Senna) C Date:02/12/03ISR Number: 4057242-7Report Type:Expedited (15-DaCompany Report #EMADSS2003001016 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Unspecified)(Risper Professional idone) PS Leponex (Clozapine) SS Date:02/12/03ISR Number: 4057276-2Report Type:Expedited (15-DaCompany Report #NSADSS2003001055 Age:40 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Diarrhoea Gastroenteritis Viral Ileus Paralytic Nausea Oral Intake Reduced Pancreatitis Sinus Tachycardia 22-Feb-2006 08:20 AM Page: 1529 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Small Intestinal Obstruction Vomiting Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Study Risperidone Increased Health (Risperidone) PS Professional Ziprasidone SS Depakote (Valproate Semisodium) C Klonopin (Clonazepam) C Lipitor (Atorvastatin) C Vasotec (Enalapril Maleate) C Neurontin (Gabapentin) C Zoloft (Sertraline Hydrochloride) C Trazodone (Trazodone) C Iron (Iron) C Multivitamins (Multivitamins) C Insulin 70/30 (Human Mixtard) C Colace (Docusate Sodium) C Date:02/13/03ISR Number: 4057178-1Report Type:Expedited (15-DaCompany Report #NSADSS2003002271 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Risperdal Initial or Prolonged Anxiety Consumer (Unspecified)(Risper Delusion Health idone) PS SEE IMAGE Paranoia Professional Ritalin Psychotic Disorder (Methylphenidate School Refusal Hydrochloride) C Social Avoidant Behaviour Suspiciousness Date:02/13/03ISR Number: 4057185-9Report Type:Expedited (15-DaCompany Report #EMADSS2002008027 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 4 MG, DAILY, ORAL Venlafaxine (Venlafaxine) C Fluoxetine (Fluoxetine) C 22-Feb-2006 08:20 AM Page: 1530 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/03ISR Number: 4057187-2Report Type:Expedited (15-DaCompany Report #EMADSS2002006856 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Abnormal Foreign Risperdal Initial or Prolonged Bradycardia Health (Unspecified) Professional (Risperidone) PS ORAL 500 MCG, DAILY, ORAL Date:02/13/03ISR Number: 4057189-6Report Type:Expedited (15-DaCompany Report #EMADSS2003000540 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Foreign Risperdal (6mg Health Tablet) Professional (Risperidone) PS ORAL 6 MG, ORAL Date:02/13/03ISR Number: 4057190-2Report Type:Expedited (15-DaCompany Report #EMADSS20030001148 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Foreign Haldol (Unspecified) Initial or Prolonged Immobile Health (Haloperidol) PS 2 MG, 1 IN 1 Lung Infection Professional DAY (S), Lymphopenia UNKNOWN Neutrophil Count Risperdal (Tablet) Increased (Risperidone) SS ORAL 4 MG, 2 IN 1 Psychotic Disorder DAILY, ORAL Tremor Carbimazole (Carbimazole) C Delix (Ramipril) C Date:02/13/03ISR Number: 4057450-5Report Type:Expedited (15-DaCompany Report #PHBS2002AU12679 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Foreign Trileptal Health (Oxcarbazepine) Professional Tablet PS ORAL ORAL Other Risperidone (Risperidone) SS ORAL ORAL Date:02/13/03ISR Number: 4057951-XReport Type:Expedited (15-DaCompany Report #NSADSS2003006191 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:02/14/03ISR Number: 4056814-3Report Type:Direct Company Report #CTU 186708 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Risperidone PS 3MG Q AM AND Movement Disorder 6MG Q HS 22-Feb-2006 08:20 AM Page: 1531 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/03ISR Number: 4057643-7Report Type:Expedited (15-DaCompany Report #EMADSS2003000980 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Oedema Foreign Risperidone Study (Risperidone) PS 1 MG, 1 IN 1 Health NIGHT (S), Professional Voltaren (Diclofenac Sodium) C Date:02/14/03ISR Number: 4057654-1Report Type:Expedited (15-DaCompany Report #EMADSS2003001179 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Risperdal (Tablet) Hospitalization - Psychotic Disorder Health (Risperidone) PS ORAL 4 MG, DAILY, Initial or Prolonged Pulmonary Embolism Professional ORAL Sudden Death Risperdal Consta (Microspheres 37.5 Mg) (Risperidone) SS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK (S), IM Orfiril (Valproate Sodium) C Beloc Zok (Metorpolol Succinate) C Ergenyl Chrono (Ergenyl Chrono) C Delix (Ramipril) C Lipidil (Fenofibrate) C Ciatyl (Clopenthixol Hydrochloride) C Diazepam (Diazepam) C Date:02/14/03ISR Number: 4059955-XReport Type:Expedited (15-DaCompany Report #EMADSS2002007588 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cachexia Foreign Risperdal ( 1mg Initial or Prolonged Decubitus Ulcer Health Tablet) Emphysema Professional (Risperidone) PS ORAL 1 MG, DAILY, Joint Contracture ORAL Pemphigoid Captopril (Captopril) SS ORAL 100 MG, DAILY, OFRAL Euglucon (Glibenclamide) C Bisomerck (Bisoprolol Fumarate) C Date:02/19/03ISR Number: 4056775-7Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0292231A Age:16 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 1532 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Deroxat PS Glaxosmithkline 20MG Per day Hypertension Risperdal SS 3G per day Date:02/19/03ISR Number: 4059589-7Report Type:Expedited (15-DaCompany Report #EMADSS2003001208 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hyperkalaemia Foreign Risperidone Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG, DAILY, ORAL Paracetamol (Paracetamol) C Calcichew D3 (Lekovit Ca) C Date:02/19/03ISR Number: 4059592-7Report Type:Expedited (15-DaCompany Report #EMADSS2003000923 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG, DAILY, ORAL Date:02/19/03ISR Number: 4059730-6Report Type:Expedited (15-DaCompany Report #APCDSS2003000194 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hemiparesis Foreign Risperidone Initial or Prolonged Health (Unspecified) Professional (Risperidone) PS ORAL SEE IMAGE Other Date:02/19/03ISR Number: 4059822-1Report Type:Expedited (15-DaCompany Report #2002056983 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apraxia Foreign Neurontin Initial or Prolonged Cerebral Atrophy Health (Gabapentin) PS ORAL ORAL Other Dementia Professional Galantamine SS ORAL 8 MG (4 MG, Difficulty In Walking TWICE DAILY), Fall ORAL Gait Disturbance Colchimax SS ORAL (DAILY), ORAL Hypertonia Citalopram Hyporeflexia Hydrochloride SS ORAL 20 MG Pain In Extremity (DAILY), ORAL Polyneuropathy Risperidone SS ORAL 0.5 MG (DAILY), ORAL Diltiazem Hydrochloride SS ORAL 180 MG (90 MG, TWICE DAILY), ORAL Glyceryl Trinitrate C 22-Feb-2006 08:20 AM Page: 1533 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heptaminol Hydrochloride C Lorazepam C Zopiclone C Paracetamol C Acetylsalicylate Lysine C Clomiopramine Hydrochloride C Molsidomine C Donepezil Hydrochloride C Tianeptine C Date:02/19/03ISR Number: 4060448-4Report Type:Expedited (15-DaCompany Report #NSADSS2003005795 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Study Risperidone Initial or Prolonged Drug Level Increased Health (Unspecified)(Risper Hepatic Encephalopathy Professional idone) PS Ziprasidone SS Olanzapine (Olanzapine) SS Quetiapine (Quetiapine) SS Zoloft (Sertraline Hydrochloride) C Gabitril (Tiagabine Hydrochloride) C Cogentin (Benzatropine Mesilate) C Artane (Trihexyphenidyl Hydrochloride) C Date:02/19/03ISR Number: 4060609-4Report Type:Expedited (15-DaCompany Report #NSADSS2003006519 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Risperdal (.25 Mg Professional Tablet) (Risperidone) PS ORAL 0.25 MG, 2 IN DAILY, ORAL Tegretol (Carbamazepine) C Date:02/19/03ISR Number: 4060611-2Report Type:Expedited (15-DaCompany Report #NSADSS2003006435 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1534 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/03ISR Number: 4058353-2Report Type:Direct Company Report #CTU 186934 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Haloperidol 2mg PS ORAL 2MG TID ORAL Initial or Prolonged Consciousness Risperidone 0.5mg SS ORAL 0.5MG TID ORAL Levofloxacin C Allopurinol C Gabapentin C Naproxen C Trazodone C Levothyroxine C Date:02/20/03ISR Number: 4060918-9Report Type:Expedited (15-DaCompany Report #FR9375116DEC2002 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Temesta (Lorazepam, Initial or Prolonged Overdose Professional Tablet, 0) PS ORAL 170 MG 1X PER Other Other 1 DAY; ORAL 1 DAY Depamide (Valpromide, ,0) SS UNKNOWN UNKNOWN 1 DAY Effexor (Venlafaxine Hydrochloride, Tablet, O) SS ORAL 2.37 G 1X PER 1 DAY; ORAL 1 DAY Parkinane Lp (Trihexyphenidyl, Capsule, Sustained Release, 0) SS ORAL 50 MG 1X PER 1 DAY; ORAL 1 DAY Risperdal (Risperidone, , 0) SS UNKNOWN UNKNOWN 1 DAY Rivotril (Clonazepam, , 0) SS UNKNOWN UNKNOWN 1 DAY Theralene (Alimemazine Tartrate, , 0) SS ORAL 30 ML 1X PER 1 DAY; ORAL 1 DAY Topiramate (Topiramate, , 0) SS UNKNOWN UNKNOWN 1 DAY Tranxene (Clorazepate Dipotassium, , 0) SS ORAL 500 MG 1X PER 1 DAY; ORAL 1 DAY Zyprexa (Olanzapine, , 0) SS ORAL 140 MG 1X PER 1 DAY; ORAL 1 DAY Date:02/20/03ISR Number: 4060919-0Report Type:Expedited (15-DaCompany Report #DEWYE007403FEB03 Age:51 YR Gender:Female I/FU:F Outcome PT Hospitalization - Bowel Sounds Abnormal Initial or Prolonged Extensor Plantar Response Hypotension Intentional Overdose Respiratory Failure Suicide Attempt 22-Feb-2006 08:20 AM Page: 1535 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tachycardia Report Source Product Role Manufacturer Route Dose Duration Health Trevilor Professional (Venlafaxine Hydrochloride, Tablet, 0) PS ORAL 100 TABLETS (OVERDOSE AMOUNT 5000MG); ORAL 1 DAY Risperdal (Risperidone, , 0) SS ORAL 50 TABLETS (OVERDOSE AMOUNT 50MG); ORAL 1 DAY Date:02/21/03ISR Number: 4062123-9Report Type:Expedited (15-DaCompany Report #EMADSS2003000765 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Risperdal (0.5 Mg Decreased Health Tablet) Platelet Count Decreased Professional (Risperidone) PS ORAL 0.5 MG, 1 IN White Blood Cell Count Company 1 DAY(S), Decreased Representative ORAL Metformin (Metformin) C Venlafaxine (Venlafaxine) C Aspirin (Acetylsalicylic Acid) C Date:02/21/03ISR Number: 4062126-4Report Type:Expedited (15-DaCompany Report #EMADSS2003001262 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Foreign Risperdal (Tablet) Increased Health (Risperidone) PS ORAL 4 MG, DAILY, Cough Professional ORAL; 6 Fatigue MG, DAILY Leukopenia ORAL Lymphocyte Count Decreased Schizophrenia Thrombocytopenia Upper Respiratory Tract Infection White Blood Cell Disorder Date:02/21/03ISR Number: 4062129-XReport Type:Expedited (15-DaCompany Report #EMADSS2001005486 Age:48 YR Gender:Female I/FU:F Outcome PT Life-Threatening Blood Creatine Phosphokinase Increased Dysphagia Headache 22-Feb-2006 08:20 AM Page: 1536 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Respiratory Failure Report Source Product Role Manufacturer Route Dose Duration Speech Disorder Foreign Risperidone Study (Unspecified) Health (Risperidone) PS SEE IMAGE Professional Topiramate (Capsule) (Topiramate) SS ORAL 3 CAP, DAILY, ORAL Placebo (Placebo) SS 3 CAP, DAILY, ORAL Lithium (Lithium) SS DATA UNSPECIFIED Lorazepam C Chloral Hydrate (Chloral Hydrate) C Diazepam (Diazepam) C Olanzapine (Olanzapine) C Senna (Senna) C Lactulose (Lactulose) C Haloperidol (Haloperidol) C Lithium Carbonate (Lithium Carbonate) C Date:02/21/03ISR Number: 4062222-1Report Type:Expedited (15-DaCompany Report #EMADSS2003000713 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Risperdal Initial or Prolonged Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Sotalex (Sotalol Hydrochloride) SS ORAL 1 TABLE, DAILY, ORAL Amlor (Amlodipine Besilate) SS 5 MG, DAILY Seropram (Citalopram Hydrobromide) SS 30 MG, DAILY Aspegic (Acetylsalicylate Lysine) SS 250 MG, DAILY Discotrine (Glyceryl Trinitrate) C Ditropan (Oxybutynin) C Date:02/21/03ISR Number: 4062223-3Report Type:Expedited (15-DaCompany Report #EMADSS2003001343 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myalgia Foreign Risperdal (6 Mg Initial or Prolonged Myositis Health Tablet) Professional (Risperidone) PS ORAL 6 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1537 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/03ISR Number: 4062224-5Report Type:Expedited (15-DaCompany Report #EMADSS2003001348 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Neonatal Foreign Risperdal (1 Mg Drug Exposure During Health Tablet) Pregnancy Professional (Risperidone) PS TAKEN BY MOTHER Haldol ( 1 Mg Tablet) (Haloperidol) SS TAKEN BY MOTHER Date:02/21/03ISR Number: 4062227-0Report Type:Expedited (15-DaCompany Report #EMADSS2003001348 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Neonatal Foreign Haldol (1 Mg Tablet) Drug Exposure During Health (Haloperidol) PS TAKEN BY Pregnancy Professional MOTHER Risperdal ( 1 Mg Tablet) (Risperidone) SS TAKEN BY MOTHER Date:02/21/03ISR Number: 4062791-1Report Type:Expedited (15-DaCompany Report #DSA_22367_2003 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apraxia Foreign Bi-Tildiem PS ORAL 180 MG Initial or Prolonged Dementia Health PER24HR PO Difficulty In Walking Professional Neurontin SS ORAL 1 G PER24HR Fall Other PO Gait Disturbance Reminyl SS ORAL 8 MG PER24HR Hypertonia PO Hyporeflexia Colchimax SS ORAL 1 U PER24HR Lacunar Infarction PO Pain In Extremity Seropram SS ORAL 20 MG PER24HR Polyneuropathy PO Risperdal SS ORAL 0.5 MG PER24HR PO Temesta C Imovane C Dafalgan C Aricept C Anafranil C Corvasal C Nitriderm C Heptamyl C Kardegic C Stablon C Date:02/24/03ISR Number: 4064753-7Report Type:Expedited (15-DaCompany Report #2003002870 Age: Gender:Female I/FU:F Outcome PT Hospitalization - Accident Initial or Prolonged Blood Pressure Decreased Other Bronchitis 22-Feb-2006 08:20 AM Page: 1538 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fall Forearm Fracture Increased Appetite Report Source Product Role Manufacturer Route Dose Duration Joint Sprain Consumer Zoloft (Sertraline) PS ORAL 200 MG Loss Of Consciousness Health (DAILY), ORAL Menorrhagia Professional Risperidone SS ORAL 3 MG (DAILY), Pneumonia Aspiration ORAL Somnolence Quetiapine Fumarate SS ORAL ORAL Suicide Attempt Ibuprofen SS ORAL ORAL Weight Increased Diphenhydramine Hydrochloride SS ORAL ORAL Fexofenadine Hydrochloride C Desloratadine C Atenolol C Date:02/25/03ISR Number: 4065254-2Report Type:Expedited (15-DaCompany Report #APCDSS2003000210 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Risperidone Diabetic Coma Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL ORAL Date:02/25/03ISR Number: 4065256-6Report Type:Expedited (15-DaCompany Report #EMADSS2003001024 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Foreign Risperdal (1 Mg Hospitalization - Blood Creatine Increased Health Tablet) Initial or Prolonged Cardiac Failure Professional (Risperidone) PS ORAL 1 MG, DAILY, Coma Company ORAL Lung Disorder Representative Aspegic Pulmonary Oedema (Acetylsalicylate Rectal Haemorrhage Lysine) C Diuretic C Date:02/25/03ISR Number: 4065494-2Report Type:Expedited (15-DaCompany Report #NSADSS2003008397 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Risperdal Hospitalization - Literature (Unspecified) Initial or Prolonged Health (Risperidone) PS ORAL 6 MG, DAILY, Professional ORAL 40 DAY Bromperidol (Bromperidol) C Date:02/25/03ISR Number: 4065552-2Report Type:Expedited (15-DaCompany Report #NSADSS2003002271 Age:13 YR Gender:Female I/FU:F Outcome PT Hospitalization - Aggression Initial or Prolonged Anxiety 22-Feb-2006 08:20 AM Page: 1539 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Delusion Medication Error Paranoia Report Source Product Role Manufacturer Route Dose Duration Psychotic Disorder Foreign Risperdal Social Avoidant Behaviour Consumer (Unspecified) Suspiciousness Health (Risperidone) PS 0.75 MG AM Weight Decreased Professional 0.5 MG HS Ritalin (Methylphenidate Hydrochloride) C Alesse 28 (Alesse (R)) C Date:02/25/03ISR Number: 4065792-2Report Type:Expedited (15-DaCompany Report #NSADSS2003007276 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:02/25/03ISR Number: 4065793-4Report Type:Expedited (15-DaCompany Report #NSADSS2003007030 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 2 MG, ORAL Date:02/25/03ISR Number: 4065794-6Report Type:Expedited (15-DaCompany Report #NSADSS2003006743 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 2 MG, 1 IN 24 HOUR (S), ORAL Date:02/25/03ISR Number: 4065795-8Report Type:Expedited (15-DaCompany Report #NSADSS2003006733 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 3 MG, 2 IN 1 DAY (S), ORAL Date:02/25/03ISR Number: 4065927-1Report Type:Expedited (15-DaCompany Report #NSADSS2003007751 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Health Risperdal Professional (Unspecified) (Risperidone) PS 0.5 MG IN A.M. AND .25 MG IN P.M. Glipizide (Glipizide) C Senekot (Sennoside 22-Feb-2006 08:20 AM Page: 1540 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report A+B) C Date:02/25/03ISR Number: 4065928-3Report Type:Expedited (15-DaCompany Report #NSADSS2003006745 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 1 MG, ORAL Date:02/25/03ISR Number: 4065929-5Report Type:Expedited (15-DaCompany Report #NSADSS2003006519 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Microcytic Anaemia Health Risperdal (.25 Mg Professional Tablet) Company (Risperidone) PS ORAL 0.25 MG, 2 IN Representative DAILY, ORAL Tegretol (Carbamazepine) C Date:02/26/03ISR Number: 4066877-7Report Type:Expedited (15-DaCompany Report #030130-PM0024-01 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Foreign Tranxene Initial or Prolonged Rhabdomyolysis Health (Clorazepate Suicide Attempt Professional Dipotassium) Tablets PS ORAL 5 MG, P.O. QD Other Risperedone Tablets SS ORAL P.O. Olanzapine Tablets SS ORAL P.O. Lithium Carbonate Tablets SS ORAL P.O. Levomepromazine Tablets SS ORAL P.O. Date:02/27/03ISR Number: 4064886-5Report Type:Direct Company Report #187610 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Akathisia Risperidone PS Anorexia Lithium C Anxiety Lamictal C Drug Withdrawal Syndrome Extrapyramidal Disorder Impulse-Control Disorder Insomnia Medication Error Nausea Psychotic Disorder Raynaud'S Phenomenon Self Injurious Behaviour Suicidal Ideation Thinking Abnormal Tremor Vomiting Weight Decreased 22-Feb-2006 08:20 AM Page: 1541 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/03ISR Number: 4067320-4Report Type:Expedited (15-DaCompany Report #EMADSS2003001520 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Inappropriate Foreign Risperdal(Risperidon Antidiuretic Hormone Health e) PS 2 MG, 2 IN 1 Secretion Professional DAY(S) 1 YR Rhabdomyolysis Promethazine (Promethazine) C Temazepam (Temazepam) C Nortrilen (Nortriptyline Hydrochloride) C Date:02/27/03ISR Number: 4067448-9Report Type:Expedited (15-DaCompany Report #2003002870 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accident Consumer Zoloft (Sertraline) PS ORAL 200 MG Initial or Prolonged Blood Pressure Decreased Health (DAILY), ORAL Other Blood Pressure Increased Professional Risperidone SS ORAL 3 MG (DAILY), Bronchitis ORAL Dry Mouth Quetiapine Fumarate SS ORAL ORAL Fall Ibuprofen SS ORAL ORAL Fear Diphenhydramine Forearm Fracture Hydrochloride SS ORAL ORAL Increased Appetite Geodon (Ziprasidone) SS ORAL ORAL Joint Sprain Fexofenadine Loss Of Consciousness Hydrochloride C Malaise Desloratadine C Menorrhagia Atenolol C Pneumonia Aspiration Somnolence Suicide Attempt Weight Increased Date:02/27/03ISR Number: 4067610-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE04203 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Tegretal Retard Apathy Consumer (Carbamazepine) Disinhibition Other Extended Release Drug Interaction Tablet PS ORAL SEE IMAGE Flat Affect ORAL Impulse-Control Disorder Trevilor Memory Impairment (Venlafaxine Personality Change Hydrochloride) SS ORAL ORAL Thinking Abnormal Risperdal Visual Disturbance (Risperidone) SS ORAL ORAL Date:02/27/03ISR Number: 4067855-4Report Type:Expedited (15-DaCompany Report #NSADSS2003006196 Age:10 YR Gender:Male I/FU:F Outcome PT Hospitalization - Drug Ineffective Initial or Prolonged Drug Interaction Dystonia 22-Feb-2006 08:20 AM Page: 1542 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tic Report Source Product Role Manufacturer Route Dose Duration Health Concerta Professional (Methyphenidate Company Hydrochloride) PS 54 MG TO 126 Representative MG02 Risperdal (Risperidone) SS Celexa (Citalopram Hydrobromide) SS Strattera (Atomoxetine) SS Depakote (Valproate Semisodium) C Buspar (Buspirone Hydrochloride) C Benadryl (Diphenhydramine Hydrochloride) C Date:02/27/03ISR Number: 4068258-9Report Type:Expedited (15-DaCompany Report #APCDSS2003000210 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperidone (Tablet) Initial or Prolonged Diabetes Mellitus Health (Risperidone) PS ORAL SEE IMAGE, Diabetic Coma Professional ORAL Psychiatric Symptom Quetiapine Fumarate (Quetiapine Fumarate) SS Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Diazepam (Diazepam) C Haldol (Haloperidol) C Date:02/27/03ISR Number: 4068352-2Report Type:Expedited (15-DaCompany Report #NSADSS2003006196 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Risperdal Initial or Prolonged Drug Interaction Professional (Risperidone) PS UNK Dystonia Company Concerta Tic Representative (Methylphenidate Hydrochloride) SS 54 MG TO 126 MG Strattera (Atomoxetine) SS UNK Celexa (Citalopram Hydrobromide) SS UNK Depakote (Valproate Semisodium) C Buspar (Buspirone Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1543 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benadryl (Diphenhydramine Hydrochloride) C Date:02/27/03ISR Number: 4068363-7Report Type:Expedited (15-DaCompany Report #NSADSS2002046469 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Obstruction Health Risperdal (1 Mg Sepsis Professional Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 24 HOUR(S), ORAL Imdur (Isosorbide Mononitrate) C Pancrease (Pancrelipase) C Insulin (Insulin) C Prevacid (Lansoprazole) C Date:02/27/03ISR Number: 4068364-9Report Type:Expedited (15-DaCompany Report #NSADSS2002043523 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Cancer Metastatic Health Risperdal Hospitalization - Professional (Unspecified) Initial or Prolonged (Risperidone) PS ORAL 2, DAILY, ORAL Atenol (Atenolol) C Potassium (Potassium) C Xalatan (Latanoprost) C Protonix (Pantoprazole) C Phenergan (Promethazine Hydrochloride) C Colace (Docusate Sodium) C Percocet (Oxycodone/Acetamino phen) C Date:02/27/03ISR Number: 4068365-0Report Type:Expedited (15-DaCompany Report #NSADSS2002014912 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Consumer Risperdal (1 Mg Hospitalization - Atrial Fibrillation Tablet) Initial or Prolonged Dysphagia (Risperidone) PS ORAL 1 MG, 1 IN 1 Pneumonia DAY(S), ORAL Psychotic Disorder 22-Feb-2006 08:20 AM Page: 1544 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4067554-9Report Type:Expedited (15-DaCompany Report #APCDSS2003000110 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Haldol (Unspecified) Initial or Prolonged Sedation Health (Haloperidol) PS 1.5 MG, DAILY Stupor Professional Risperidone (Risperidone) SS ORAL 2 MG, DAILY, ORAL Lorazepam (Lorazepam) SS 1.5 MG, DAILY Flunitrazepam (Flunitrazepam) SS Date:02/28/03ISR Number: 4067582-3Report Type:Expedited (15-DaCompany Report #EMADSS2003000584 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 Company DAY (S), ORAL Representative Sodium Valproate Other (Valproate Sodium) C Date:02/28/03ISR Number: 4067583-5Report Type:Expedited (15-DaCompany Report #EMADSS2003001570 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Risperdal Cardiac Arrest Health (Risperidone) PS ORAL SEE IMAGE Excitability Professional Tercian Fatigue (Cyamemazine) C Myocardial Infarction Valium (Diazepam) C Depakote (Valproate Semisodium) C Date:02/28/03ISR Number: 4067584-7Report Type:Expedited (15-DaCompany Report #EMADSS2003001618 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cortisol Increased Foreign Risperdal Cushingoid Health (Risperidone) PS ORAL 8 MG, DAILY, Hyperprolactinaemia Professional ORAL Obesity Company Oedema Representative Date:02/28/03ISR Number: 4067585-9Report Type:Expedited (15-DaCompany Report #APCDSS2003000194 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hemiparesis Foreign Risperidone PS ORAL SEE IMAGE Initial or Prolonged Health Professional 22-Feb-2006 08:20 AM Page: 1545 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/03ISR Number: 4067586-0Report Type:Expedited (15-DaCompany Report #EMADSS2003001511 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Difficulty In Walking Foreign Risperdal Dry Mouth Health (Risperidone) PS ORAL 1 MG, 2 IN 1 Dysphagia Professional DAY (S), ORAL Extrapyramidal Disorder Magnesium Hydroxide (Magnesium Hydroxide) C Seroxat (Paroxetine Hydrochloride) C Date:02/28/03ISR Number: 4068613-7Report Type:Expedited (15-DaCompany Report #NSADSS2003008522 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 0.25 MG, DAILY, ORAL Date:02/28/03ISR Number: 4068616-2Report Type:Expedited (15-DaCompany Report #NSADSS2003008042 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 1 MG, DAILY, ORAL Date:02/28/03ISR Number: 4068622-8Report Type:Expedited (15-DaCompany Report #NSADSS2003008279 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperidal Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Prozac (Fluoxetine Hydrochloride) C Date:02/28/03ISR Number: 4068626-5Report Type:Expedited (15-DaCompany Report #NSADSS2003002066 Age:95 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL 0.5 MG, 2 IN Professional 1 DAY(S), ORAL Date:02/28/03ISR Number: 4068630-7Report Type:Expedited (15-DaCompany Report #NSADSS2003001563 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperidal Professional (Risperidone) PS ORAL 2, 2 IN 22-Feb-2006 08:20 AM Page: 1546 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAILY, ORAL Paxil (Paroxetine Hydrochloride) C Date:02/28/03ISR Number: 4068640-XReport Type:Expedited (15-DaCompany Report #NSADSS2002043103 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Risperdal Hospitalization - Cough Professional (Risperidone) PS ORAL 3 MG, DAILY, Initial or Prolonged Dehydration ORAL Diabetes Mellitus Celexa (Citalopram Dry Mouth Hydrobromide) C Hypokalaemia Seroquel (Seroquel) C Nausea Norvasc (Amlodipine Oedema Besilate) C Somnolence Hctz Treatment Noncompliance (Hctz/Reserpine) C Vomiting Artane Weight Increased (Trihexyphenidyl Hydrochloride) C Glucophage (Metformin Hydrochloride) C Avapro (Irbesartan) C Trihexy-5 (Trihexyphenidyl) C Date:02/28/03ISR Number: 4068677-0Report Type:Expedited (15-DaCompany Report #NSADSS2003008787 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:02/28/03ISR Number: 4068678-2Report Type:Expedited (15-DaCompany Report #NSADSS2003008539 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:02/28/03ISR Number: 4068680-0Report Type:Expedited (15-DaCompany Report #NSADSS2003008775 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1547 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/03ISR Number: 4069043-4Report Type:Expedited (15-DaCompany Report #EMADSS2003000972 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Risperdal Initial or Prolonged Face Oedema Health (Risperidone) PS ORAL SEE IMAGE Oedema Peripheral Professional Nozinan Company (Levomepromazine) C Representative Date:03/03/03ISR Number: 4069044-6Report Type:Expedited (15-DaCompany Report #EMADSS2002006856 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal Initial or Prolonged Health (Risperidone) PS ORAL 500 MCG, Professional DAILY, ORAL Date:03/03/03ISR Number: 4069045-8Report Type:Expedited (15-DaCompany Report #EMADSS2003001573 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Risperidone) PS ORAL 0.5 MG, Professional DAILY, ORAL Other Metformin (Metformin) C Efexor (Venlafaxine Hydrochloride) C Aspirin (Acetylsalicylic Acid) C Date:03/03/03ISR Number: 4069467-5Report Type:Expedited (15-DaCompany Report #APCDSS2002001344 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal (2 Mg Delirium Health Tablet) Neutropenia Professional (Risperidone) PS ORAL 2 MG, DAILY, Schizoaffective Disorder ORAL White Blood Cell Count Decreased Date:03/03/03ISR Number: 4069776-XReport Type:Expedited (15-DaCompany Report #NSADSS2003008772 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 2 IN 24 HOUR(S), ORAL 22-Feb-2006 08:20 AM Page: 1548 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/03ISR Number: 4069823-5Report Type:Expedited (15-DaCompany Report #2003002622 Age:37 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Sinequan (Cap) Health (Doxepin) PS Professional Risperidone SS Cocaine SS Date:03/04/03ISR Number: 4065482-6Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0293775A Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Health Lithium Carbonate PS Glaxosmithkline Initial or Prolonged Rhabdomyolysis Professional Tranxene SS ORAL 5MG Four Suicide Attempt times per day Risperidone SS ORAL Olanzapine SS Levomepromazine SS Date:03/04/03ISR Number: 4065572-8Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0279514A Age:93 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Deroxat PS Glaxosmithkline ORAL 20MG Per day Hallucination, Visual Professional Risperdal SS ORAL Nightmare Stilnox SS ORAL 5MG Per day Mopral C ORAL 20MG Per day Serc C ORAL 24MG per day Zestoretic C ORAL 1TAB Per day Mediatensyl C ORAL 60MG per day Loxen C ORAL 100MG per day Date:03/04/03ISR Number: 4069999-XReport Type:Expedited (15-DaCompany Report #NSADSS2003009049 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 2 MG, DAILY, ORAL; 0.5 MG, 2 IN 1 DAY(S), ORAL Zitromax (Azithromycin) C Vasotec (Enalapril Maleate) C Celexa (Citalopram Hydrobromide) C Proventil (Salbutamol) C Atrovent (Ipratropium Bromide) C 22-Feb-2006 08:20 AM Page: 1549 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/03ISR Number: 4070000-2Report Type:Expedited (15-DaCompany Report #NSADSS2003009207 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Risperdal Initial or Prolonged Professional (Unspecified) Company (Risperidone) PS ORAL ORAL Representative Date:03/04/03ISR Number: 4070007-5Report Type:Expedited (15-DaCompany Report #EMADSS2003001339 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 3 MG, DAILY, ORAL Tercian (Cyamemazine) C Lepticur (Tropatepine Hydrochloride) C Date:03/04/03ISR Number: 4070070-1Report Type:Expedited (15-DaCompany Report #NSADSS2003009044 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Health Risperdal (Tablet) Brain Neoplasm Professional (Risperidone) PS ORAL ORAL Company Representative Date:03/04/03ISR Number: 4070542-XReport Type:Expedited (15-DaCompany Report #EMADSS2003001676 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Influenza Foreign Risperdal (3 Mg Leukopenia Health Tablet) Neutropenia Professional (Risperidone) PS ORAL 3 MG, DAILY, ORAL Akineton (Biperiden Hydrochloride) C Tavor (Lorazepam) C Cipramil (Citalopram) C Date:03/05/03ISR Number: 4066291-4Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0293076A Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Paxil PS Glaxosmithkline ORAL 30MG per day Initial or Prolonged Joint Stiffness Professional Fluvoxamine Maleate SS ORAL 200MG per day Other Speech Disorder Risperidone SS ORAL 2MG per day Phenothiazine SS ORAL Over Counter Cold Remedy SS ORAL 22-Feb-2006 08:20 AM Page: 1550 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/03ISR Number: 4071121-0Report Type:Expedited (15-DaCompany Report #NSADSS2003000884 Age:93 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Embolic Stroke Foreign Risperdal Hospitalization - Hallucination Consumer (Risperidone) PS ORAL 1 MG, PRN, Initial or Prolonged ORAL Seroquel (Seroquel) C Prednisone (Prednisone) C Eltroxin (Levothyroxine Sodium) C Metoprolol (Metoprolol) C Flovent (Flucitasone Propionate) C Salbutamol (Salbutamol) C Atrovent (Ipratropium Bromide) C Nitro-Dur (Glyceryl Trinitrate) C Senokot (Senna Fruit) C Acetaminophen (Paracetamol) C Date:03/05/03ISR Number: 4071122-2Report Type:Expedited (15-DaCompany Report #APCDSS2003000210 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperidone (Tablet) Initial or Prolonged Dehydration Health (Risperidone) PS ORAL SEE IMAGE Diabetes Mellitus Professional Trihexyphenidyl Diabetic Coma Hydrochloride Infection (Trihexyphenidyl Leukopenia Hydrochloride) C 500 MG DAILY Psychiatric Symptom Diazepam (Diazepam) C Haldol (Haloperidol) C Date:03/05/03ISR Number: 4071188-XReport Type:Expedited (15-DaCompany Report #APCDSS2003000294 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Risperdal Myocardial Ischaemia Consumer (Unspecified) Rash Health (Risperidone) PS 2 MG MANE ADN Tremor Professional 3 MG NOCTE Date:03/06/03ISR Number: 4066833-9Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0292231A Age:16 YR Gender:Female I/FU:F Outcome PT Other Blood Aldosterone Increased Condition Aggravated Drug Interaction 22-Feb-2006 08:20 AM Page: 1551 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Epistaxis Hypertension Renin Increased Report Source Product Role Manufacturer Route Dose Duration Health Deroxat PS Glaxosmithkline 20MG Per day Professional Risperdal SS 3G per day Tercian C Zyprexa C Date:03/06/03ISR Number: 4068850-1Report Type:Direct Company Report #CTU 188028 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Osteoporosis Risperdal 2mg PS ORAL 2MG BID Intervention to ORAL Prevent Permanent Impairment/Damage Date:03/06/03ISR Number: 4068852-5Report Type:Direct Company Report #CTU 188029 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Urinary Retention Risperdal 1mg PS ORAL 1.5MG HS Intervention to ORAL Prevent Permanent Impairment/Damage Date:03/06/03ISR Number: 4071736-XReport Type:Expedited (15-DaCompany Report #NSADSS2003009617 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Systemic Lupus Health Risperdal Erythematosus Professional (Risperidone) PS ORAL 4 MG, 2 IN DAILY, ORAL; 3 MG, 2 IN DAILY, ORAL; 3 MG 3 IN Seroquel (Seroquel) C Cogentin (Benzatropine Mesilate) C Ativan (Lorazepam) C Date:03/06/03ISR Number: 4071857-1Report Type:Expedited (15-DaCompany Report #EMADSS2003001787 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Disorder Foreign Risperdal Body Temperature Health (Risperidone) PS ORAL SEE IMAGE Increased Professional Lorazepam Haemoglobin Decreased (Lorazepam) C Leukopenia Multibionta (Multibionta) C Pantozol (Pantoprazole Sodium) C 22-Feb-2006 08:20 AM Page: 1552 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/06/03ISR Number: 4071858-3Report Type:Expedited (15-DaCompany Report #APCDSS2003000293 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Risperdal (Tablet) Initial or Prolonged Health (Risperidone) PS ORAL 4 MG, DAILY, Professional ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Levomepromazine Maleate (Levomepromazine Maleate) C Fluphenazine Hydrochloride (Fluphenazine Hydrochloride) C Date:03/07/03ISR Number: 4072409-XReport Type:Expedited (15-DaCompany Report #03-02-0236 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Clozapine Tablets PS ORAL 750 MG QD Initial or Prolonged Neuroleptic Malignant Literature ORAL 29 MON Other Syndrome Health Risperidone Tablets SS ORAL 3-4 MG QD Schizophrenia Professional ORAL 3 MON Date:03/07/03ISR Number: 4072523-9Report Type:Expedited (15-DaCompany Report #APCDSS2002001273 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Haldol (Tablet) Condition Aggravated Health (Haloperidol) PS ORAL 18 MG, DAILY, Delusion Professional ORAL; 9 MG, Disturbance In Attention DAILY, ORAL Fatigue Risperidone (Tablet) Hallucination (Risperidone) SS ORAL 4 MG, DAILY, Malaise ORAL Muscle Rigidity Trihexyphenidyl Somnolence Hydrochloride Treatment Noncompliance (Trihexyphenidyl Hydrochloride) C Bipiriden Hydrochloride (Biperiden Hydrochloride) C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Bromazepam (Bromazepam) C Brotizolam (Brotizolam) C 22-Feb-2006 08:20 AM Page: 1553 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/03ISR Number: 4072524-0Report Type:Expedited (15-DaCompany Report #APCDSS2003000136 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Risperidone (Tablet) Required Blood Creatine Health (Risperidone) PS ORAL 3 MG, DAILY, Intervention to Phosphokinase Increased Professional ORAL Prevent Permanent Cardiac Arrest Lidocaine Impairment/Damage Convulsion (Lidocaine) SS INTRAVENOUS 72 MG, DAILY, Disorientation IV Electrocardiogram Nicorandil Abnormal (Nicorandil) C Electrocardiogram Pq Bufferin (Bufferin) C Interval Prolonged Ticlopidine Electrocardiogram Qrs Hydrochloride Complex Abnormal (Ticlopidine Failure Of Implant Hydrochloride) C Hallucination, Visual Cilostazol Loss Of Consciousness (Cilostazol) C Restlessness Cefazolin Sodium (Cefazolin Sodium) C Heparin Sodium (Heparin Sodium) C Omeprazole (Omeprazole) C Mexiletine Hydrochloride (Mexiletine Hydrochloride) C Date:03/07/03ISR Number: 4072525-2Report Type:Expedited (15-DaCompany Report #EMADSS2003001821 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Normochromic Normocytic Foreign Risperdal Anaemia Health (Unspecified) Professional (Risperidone) PS ORAL 2 MG, DAILY, ORAL Diffu K (Potassium Chloride) C Date:03/07/03ISR Number: 4072959-6Report Type:Expedited (15-DaCompany Report #PHBS2003CA02113 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disease Recurrence Foreign Clozapine Initial or Prolonged Drug Interaction Literature (Clozapine) PS 750 MG/D, Potentiation Health Risperidone Neuroleptic Malignant Professional (Risperidone) SS 6 MG/D, Syndrome Other Psychotic Disorder Date:03/10/03ISR Number: 4073030-XReport Type:Expedited (15-DaCompany Report #NSADSS2002038963 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Perforated Ulcer Health Risperdal Renal Failure Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1554 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prilosec (Omeprazole) C Zestril (Lisinopril) C Remeron(Mirtazapine) C Zoloft(Sertraline Hydrochloride) C Exelon (Rivastigmine) C Detrol (Tolterodine L-Tartrate) C Vioxx (Rofecoxib) C Macrodantin (Nitrofurantoin) C Lotrisone Creame (Lotrisone) C Furosemide (Furosemide) C Date:03/10/03ISR Number: 4073934-8Report Type:Expedited (15-DaCompany Report #EMADSS2003001783 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Concussion Foreign Risperidone Initial or Prolonged Fall Study (Solution) Head Injury Health (Risperidone) PS ORAL 0.75 MG, 1 IN Syncope Professional 1 DAY(S), Vomiting ORAL Date:03/10/03ISR Number: 4073935-XReport Type:Expedited (15-DaCompany Report #EMADSS200301729 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperidone Study (Risperidone) PS ORAL 1 MG, DAILY, Health ORAL Professional Nitrates (Nitrates) C Date:03/11/03ISR Number: 4072646-4Report Type:Direct Company Report #CTU 188438 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Risperidone 3mg Initial or Prolonged Jansen PS Jansen ORAL 6MG QD PO Required Prozac C Intervention to Fish Oil C Prevent Permanent Lactulose C Impairment/Damage Lorazepam C Date:03/11/03ISR Number: 4074026-4Report Type:Expedited (15-DaCompany Report #NSADSS2003010108 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal ( .25 Mg Professional Tablet) (Risperidone) PS ORAL 0.25 MG, 2 IN DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1555 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/11/03ISR Number: 4074082-3Report Type:Expedited (15-DaCompany Report #NSADSS2003009897 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:03/11/03ISR Number: 4074083-5Report Type:Expedited (15-DaCompany Report #NSADSS2003009901 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:03/11/03ISR Number: 4074994-0Report Type:Expedited (15-DaCompany Report #APCDSS2003000210 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Risperidon (Tablet) Initial or Prolonged Diabetes Mellitus Health (Risperidone) PS ORAL 12 MG, DAILY, Diabetic Coma Professional ORAL Infection Quetiapine Fumarate Leukopenia (Quetiapine Psychiatric Symptom Fumarate) SS ORAL 500 MG, Schizophrenia DAILY, ORAL; 8 MG, DAILY, ORAL; 12 MG, DAILY, ORAL Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Diazepam (Diazepam) C Haldol (Unspecified) (Haloperidol) C Date:03/11/03ISR Number: 4074995-2Report Type:Expedited (15-DaCompany Report #APCDSS2002001364 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Foreign Risperidone (Tablet) Hospitalization - Abnormal Behaviour Health (Risperidone) PS ORAL 4 MG, DAILY, Initial or Prolonged Aggression Professional ORAL; 5 MG, Cold Sweat DAILY ORAL; 6 Diabetes Mellitus MG, DAILY; Diabetic Hyperosmolar ORAL; 5 MG, Coma Milnacipran Diabetic Ketoacidosis Hydrochloride Insomnia (Milnacipran) SS ORAL 30 MG, DAILY, Major Depression ORAL; 40 MG, Nasopharyngitis DAILY, ORAL Nausea Levomepromazine Pallor Maleate Peripheral Coldness (Levopromazine Psychiatric Symptom Maleate) C 22-Feb-2006 08:20 AM Page: 1556 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/11/03ISR Number: 4074996-4Report Type:Expedited (15-DaCompany Report #NSADSS2003008397 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperdal Hospitalization - Pulmonary Embolism Literature (Unspecified) Initial or Prolonged Health (Risperidone) PS ORAL 6 MG, DAILY, Professional ORAL Bromperidol (Bromperidol) SS 18 MG, DAILY Lorazepam (Lorazepam) C Estazolam (Estazolam) C Biperiden (Biperiden) C Date:03/11/03ISR Number: 4074997-6Report Type:Expedited (15-DaCompany Report #EMADSS2003001922 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Company Representative Date:03/12/03ISR Number: 4072000-5Report Type:Direct Company Report #CTU 188574 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Risperdone 0.25 Mg PS ORAL 0.25 MG QHS Initial or Prolonged Consciousness ORAL Fall Olanzapine 2.5 Mg SS ORAL 2.5 MG QHS Medication Error ORAL Miacalcin Spray C Vitamin E C Date:03/12/03ISR Number: 4072970-5Report Type:Direct Company Report #CTU 188593 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal Galactorrhoea (Risperidone) 3 Mg Qhs - Janssen PS Janssen ORAL 3 MG PO 9 MON Serzone C Norgesic C Flexeril C Nexium C Reglan C Allegra C Date:03/12/03ISR Number: 4074879-XReport Type:Expedited (15-DaCompany Report #NSADSS2002019508 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal (Tablet) Professional (Risperidone) PS ORAL 1.5 MG, 22-Feb-2006 08:20 AM Page: 1557 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAILY, ORAL Depakote (Valproate Semisodium) C Date:03/12/03ISR Number: 4074880-6Report Type:Expedited (15-DaCompany Report #NSADSS2002019408 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Risperdal (Tablet) White Blood Cell Count Professional (Risperidone) PS ORAL 3, DAILY, Decreased ORAL Depakote (Valproate Semisodium) SS Zoloft (Sertraline Hydrochloride) C Date:03/12/03ISR Number: 4074881-8Report Type:Expedited (15-DaCompany Report #NSADSS2002019600 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Risperdal (Tablet) Decreased Professional (Risperidone) PS ORAL ORAL Depakote (Valproate Semisodium) C Date:03/12/03ISR Number: 4075202-7Report Type:Expedited (15-DaCompany Report #EMADSS2003001343 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal (Tablet) Initial or Prolonged Phosphokinase Increased Health (Risperidone) PS ORAL 2; 4; 6 MG, Myalgia Professional DAILY, ORAL Myositis Date:03/12/03ISR Number: 4075204-0Report Type:Expedited (15-DaCompany Report #EMADSS2003001941 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Cardiomyopathy Foreign Risperdal Congenital Anomaly Health (Risperidone) PS OTHER OTHER Maternal Drugs Affecting Professional Foetus Date:03/12/03ISR Number: 4075233-7Report Type:Expedited (15-DaCompany Report #APCDSS2003000341 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Foreign Haldol (Tablet) Anal Fistula Health (Haloperidol) PS ORAL 6.75 MG, Delusion Professional DAILY, ORAL Depression Haldol (Injection) Gastrointestinal Injury (Haloperidol) SS INTRAMUSCULAR 5 MG, DAILY, Intentional Self-Injury IM Laceration Risperdal (Tablet) Malaise (Risperidone) SS ORAL 3 MG, DAILY, Suicidal Ideation ORAL Milnacipran 22-Feb-2006 08:20 AM Page: 1558 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride (Milnacipran) SS ORAL 45 MG, DAILY, ORAL Etizolam (Etizolam) C Estazolam (Estalozam) C Flunitrazepam (Flunitrazepam) C Triazolam (Triazolam) C Amoxapine (Amoxapine) C Thioridazine Hydrochloride (Thioridazine Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:03/13/03ISR Number: 4075597-4Report Type:Expedited (15-DaCompany Report #EMADSS2003002019 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Clonic Convulsion Foreign Risperdal (2 Mg Hospitalization - Dyskinesia Health Tablet) Initial or Prolonged Eosinophilia Professional (Risperidone) PS ORAL 2 MG, DAILY, Motor Dysfunction ORAL Nervous System Disorder Quadriplegia Date:03/13/03ISR Number: 4076345-4Report Type:Expedited (15-DaCompany Report #NSADSS2003010427 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Knee Operation Consumer Risperdal (0.5 Mg Platelet Aggregation Tablet) Abnormal (Risperidone) PS ORAL 0.5 MG, 1 IN Post Procedural Haematoma DAILY, ORAL Prozac (Fluoxetine Hydrochloride) C Date:03/13/03ISR Number: 4076346-6Report Type:Expedited (15-DaCompany Report #NSADSS2003010425 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, DAILY, ORAL Date:03/13/03ISR Number: 4076349-1Report Type:Expedited (15-DaCompany Report #NSADSS2002047580 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) 22-Feb-2006 08:20 AM Page: 1559 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) PS ORAL ORAL Date:03/13/03ISR Number: 4076350-8Report Type:Expedited (15-DaCompany Report #NSADSS2002042011 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Paxil (Paroxetine Hydrochloride) C Date:03/14/03ISR Number: 4072444-1Report Type:Expedited (15-DaCompany Report #WAES 0209DEU00157 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Health Vioxx PS Merck & Co., Inc ORAL 6 DAY Hospitalization - Cardiac Arrest Professional Metoprolol Succinate SS ORAL Initial or Prolonged Drug Interaction Risperidone SS ORAL Risperidone SS ORAL 8 DAY Indapamide And Perindopril Erbumine C ORAL 34 DAY Date:03/14/03ISR Number: 4076589-1Report Type:Expedited (15-DaCompany Report #B0294502A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Endometrial Cancer Foreign Chlorpromazine Initial or Prolonged Hyperprolactinaemia Study Hydrochloride Other Oligomenorrhoea Literature (Formulation Health Unknown) Professional (Chlorpromazine Hcl) PS 80 MON Risperidone (Formulation Unknown) (Risperidone) SS 252 MON Date:03/14/03ISR Number: 4076640-9Report Type:Expedited (15-DaCompany Report #NSADSS2003005795 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Risperidone Initial or Prolonged Ammonia Increased Health (Risperidone) PS Balance Disorder Professional Zoloft (Sertraline Convulsion Hydrochloride) C Delirium Gabitril Disorientation (Tiagabinehydrochlor Drug Level Above ide) C Therapeutic Cogentin Drug Screen Positive (Benzatropine Gait Disturbance Mesilate) C Hepatic Encephalopathy Artane Incoherent (Trihexyphenidyl Metabolic Encephalopathy Hydrochloride) C Restlessness Viagra (Sildenafil) C Splenomegaly Prilosec Tremor (Omeprazole) C 22-Feb-2006 08:20 AM Page: 1560 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/14/03ISR Number: 4077005-6Report Type:Expedited (15-DaCompany Report #APCDSS2003000293 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Foreign Risperdal(Tablet) Initial or Prolonged Leukocytosis Health (Risperidone) PS ORAL SEE IMAGE Neuroleptic Malignant Professional Chlorpromazine Syndrome Hydrochloride(Chlorp Renal Impairment romazine Rhabdomyolysis Hydrochloride) SS ORAL 60 MG, DAILY, ORAL Levomepromazine Maleate(Levomepromaz ine Maleate) SS ORAL 10 MG, DAILY, ORAL Biperiden Hydrochloride(Biperi den Hydrochloride) SS ORAL 3 MG, DAILY, ORAL Fluphenazine Hydrochloride(Fluphe nazine Hydrochloride) SS INTRAMUSCULAR 50 MG, DAILY, IM Flunitrazepam(Flunit razepam) C Date:03/14/03ISR Number: 4077006-8Report Type:Expedited (15-DaCompany Report #EMADSS2003002089 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Foreign Risperdal (1 Mg Initial or Prolonged Disease Recurrence Health Tablet) Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL; 2 MG, DAILY, ORAL Seroxat (Paroxetine Hydrochloride) C Diazepam (Diazepam) C Norvasc (Amlodipine Besilate) C Beloc Mite (Metoprolol Tartrate) C Hct Hexal (Hexachlorophene) C Lozaar 50 (Lozar) C Euthyrox (Levothyroxine Soidum) C Date:03/14/03ISR Number: 4077007-XReport Type:Expedited (15-DaCompany Report #EMADSS2003002097 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Risperdal Initial or Prolonged Drug Interaction Health (Risperidone) PS ORAL 8 MG, DAILY, Hyponatraemia Professional ORAL Neuroleptic Malignant Loxapac (Loxapine Syndrome Succinate) SS INTRAMUSCULAR 100 MG, IM 22-Feb-2006 08:20 AM Page: 1561 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Parkinane (Trihexyphenidyl Hydrochloride) C Tranxene (Clorazepate Dipotassium) C Tranxene (Clorazepate Dipotassium) C Tranxene (Clorazepate Dipotassium) C Seresta (Oxazepam) C Stilnox (Zolpidem) C Vitamins (Vitamins) C Date:03/17/03ISR Number: 4074722-9Report Type:Direct Company Report #CTU 188838 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Risperidone 1mg Tongue Oedema Janssen PS Janssen ORAL 1MG BID ORAL Date:03/17/03ISR Number: 4077281-XReport Type:Expedited (15-DaCompany Report #A01200300581 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Literature Divalproex Sodium PS Initial or Prolonged Health Risperidone SS Professional Clonazepam C Date:03/17/03ISR Number: 4077443-1Report Type:Expedited (15-DaCompany Report #1670009A Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anoxic Encephalopathy Foreign Unspecified Initial or Prolonged Pulmonary Embolism Literature Loperamide Disability Pulse Absent Health Hydrochloride Professional Product PS ORAL 2 DAILY, PO 2 DAY Risperidone SS ORAL 2 MG, DAILY, PO 6 DAY Benzodiazepine C Phenytoin C Maalox C Date:03/17/03ISR Number: 4077566-7Report Type:Expedited (15-DaCompany Report #EMADSS2003000517 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Risperdal Initial or Prolonged Fall Health (Unspecified) Required Loss Of Consciousness Professional (Risperidone) PS 1 MG; 9 MG, Intervention to Meningeal Neoplasm DAILY Prevent Permanent Pleural Effusion Deroxat (Paroxetine Impairment/Damage Rib Fracture Hydrochloride) SS 10 MG, DAILY, Sarcoma Zyprexa (Olanzapine) SS 10 MG, DAILY Suicide Attempt Temesta (Lorazepam) SS 2 MG, DAILY 22-Feb-2006 08:20 AM Page: 1562 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/03ISR Number: 4077603-XReport Type:Expedited (15-DaCompany Report #APCDSS2003000341 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anal Fistula Foreign Haldol (Tablet) Delirium Health (Haloperidol) PS ORAL 6.75 MG , Delusion Professional DAILY, ORAL Depression Haldol (Injection) Drug Ineffective (Haloperidol) SS INTRAMUSCULAR 5 MG, DAILY, Indifference IM Intentional Self-Injury Risperdal (Tablet) Laceration (Risperidone) SS ORAL 3 MG, DAILY, Suicidal Ideation ORAL Milnacipran Hydrochloride (Milnacipran) SS ORAL 45 MG, DAILY, ORAL Etizolam(Etizolam) C Estazolam(Estazolam) C Flunitrazepam(Flunit razepam) C Triazolam(Triazolam) C Amoxapine (Amoxapine) C Thioridazine Hydrochloride (Thioridazine Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:03/17/03ISR Number: 4077723-XReport Type:Expedited (15-DaCompany Report #02P-163-0190536-00 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Literature Depakote (Divalproex Initial or Prolonged Weight Increased Health Sodium) (Divalproex Professional Sodium ) PS ORAL 1175 MG, 1 IN Company 1 D, PER ORAL Representative Risperidone SS Clozapine C Clonazepam C Date:03/17/03ISR Number: 4077776-9Report Type:Expedited (15-DaCompany Report #02P-163-0190535-00 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Literature Depakote (Divalproex Initial or Prolonged Non-Insulin-Dependent Health Sodium) (Divalproex Required Dizziness Professional Sodium) PS ORAL SEE IMAGE Intervention to Fall Company Risperidone SS 5 MG, 1 IN 1 Prevent Permanent Fatigue Representative D Impairment/Damage Syncope Weight Increased 22-Feb-2006 08:20 AM Page: 1563 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/03ISR Number: 4073379-0Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0294502A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Endometrial Cancer Chlorpromazine PS Glaxosmithkline 37.5MG per Initial or Prolonged Hyperprolactinaemia day 80 MON Other Oligomenorrhoea Risperidone SS 2MG per day 80 MON Date:03/18/03ISR Number: 4078058-1Report Type:Expedited (15-DaCompany Report #NSADSS2003011279 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, 2 IN DAILY, ORAL Date:03/18/03ISR Number: 4078059-3Report Type:Expedited (15-DaCompany Report #NSADSS2003011298 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet) Professional (Risperidone) PS ORAL ORAL Date:03/18/03ISR Number: 4078185-9Report Type:Expedited (15-DaCompany Report #M0249-2003 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Health Mirtazapine PS ORAL SEE IMAGE 2 DAY Abnormal Professional Risperidone SS ORAL SEE IMAGE 6 DAY Acetylsalicylic Acid C Torasemide C Aquaphor C Levothyroxine Sodium C Potassium Chloride C Lorazepam C Date:03/18/03ISR Number: 4078230-0Report Type:Expedited (15-DaCompany Report #APCDSS2003000136 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Foreign Risperidone (Tablet) Required Infarction Health (Risperidone) PS ORAL 3 MG, DAILY, Intervention to Atrioventricular Block Professional ORAL Prevent Permanent Convulsion Lidocaine Impairment/Damage Disorientation (Lidocaine) SS INTRAVENOUS 72 MG, DAILY, Fall IV Hallucination, Visual Nicorandil Loss Of Consciousness (Nicorandil) C Medical Device Bufferin (Bufferin) C Complication Ticlopidine Restlessness Hydrochloride Ventricular Extrasystoles (Ticlopidine Hydrochloride) C Cilostazol (Cilostazol) C Cefazolin Sodium (Cefazolin Sodium) C 22-Feb-2006 08:20 AM Page: 1564 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heparin Sodium (Heparin Sodium) C Omeprazole (Omeprazole) C Mexiletine Hydrochloride (Mexiletine Hydrochloride) C Date:03/18/03ISR Number: 4078232-4Report Type:Expedited (15-DaCompany Report #APCDSS2002001459 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Risperdal (Tablet) Initial or Prolonged Amnesia Health (Risperidone) PS ORAL 4 MG, DAILY, Anorexia Professional ORAL Anxiety Biperiden Blood Calcium Decreased Hydrochloride Blood Cholesterol (Biperiden Increased Hydrochloride) C Blood Creatine Nitrazepam Phosphokinase Increased (Nitrazepam) C Blood Potassium Decreased Sennoside Blood Prolactin Increased (Sennosides) C Constipation Lansoprazole Delusional Disorder, (Lansoprazole) C Erotomanic Type Mosapride Citrate Depression (Mosapride) C Gastritis Atrophic Domperidone (Tablet) Medication Error (Domperidone) C Monocytosis Nasopharyngitis Overdose Stress Weight Decreased Date:03/18/03ISR Number: 4078234-8Report Type:Expedited (15-DaCompany Report #EMADSS2003000671 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Liver Function Test Health (Risperidone) PS SEE IMAGE Other Abnormal Professional Efexor (Venlafaxine Hydrochloride) SS 225 MG, DAILY Remeron (Mirtazapine) SS 30 MG, DAILY Dalmadorm (Flurazepam Hydrochloride) C Seresta (Oxazepam) C Date:03/18/03ISR Number: 4078366-4Report Type:Expedited (15-DaCompany Report #EMADSS2003000585 Age: Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged Disability 22-Feb-2006 08:20 AM Page: 1565 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Fall Foreign Risperdal Femur Fracture Health (Risperidone) PS 0.5 MG Professional Temesta (Lorazepam) SS 1 MG Other Aspirin (Acetylsalicylic Acid) C Date:03/19/03ISR Number: 4076524-6Report Type:Direct Company Report #CTU 189074 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Lithium 300mg And Initial or Prolonged Blood Pressure Increased 150mg PS ORAL 450MG TWO DAY Required Dizziness ORAL Intervention to Dyskinesia Resperdal 1mg And Prevent Permanent Dyspnoea .5mg SS ORAL 1.5MG THREE Impairment/Damage Fatigue TIMES DAY Headache ORAL Memory Impairment Productive Cough Speech Disorder Tremor Date:03/19/03ISR Number: 4078499-2Report Type:Direct Company Report #190129 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ascites Health Risperidone Capsule, Initial or Prolonged Convulsion Professional 1.5mg (Hydroxypropyl Drug Interaction Methylcellulose) PS ORAL Drug Level Increased Zoloft C Drug Screen Positive Gabitril C Hepatic Encephalopathy Artane C Metabolic Encephalopathy Cogentin C Splenomegaly Prilosec C Viagra C Date:03/19/03ISR Number: 4091454-1Report Type:Periodic Company Report #NSADSS2003006586 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorgasmia Consumer Ortho Evra (150/20 Transdermal System) (Norelgestromin/ Ethinyl Estradiol) PS TRANSDERMAL 1 PATCH, 3 IN 4 WEEK(S), TRANSD Risperdal SS Fied) (Risperibone) C Lamictal (Lamotrigine) C 22-Feb-2006 08:20 AM Page: 1566 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/03ISR Number: 4080136-8Report Type:Expedited (15-DaCompany Report #JAAUS39909 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Contusion Foreign Risperidone Fall Study (Solution) Haemorrhage Intracranial Health (Risperidone) PS ORAL 1 MG, 2 IN 1 Professional DAY(S), ORAL Date:03/20/03ISR Number: 4080142-3Report Type:Expedited (15-DaCompany Report #EMADSS2003002179 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperidone Oedema Health (Solution) Pleural Effusion Professional (Risperidone) PS ORAL 0.75 MG, 2 IN 1 DAILY, ORAL Beta Blocking Agents (Beta Blocking Agents) C Marcumar (Phenprocoumon) C Nitrate C Date:03/20/03ISR Number: 4080143-5Report Type:Expedited (15-DaCompany Report #APCDSS2003000397 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemorrhage Foreign Risperidone (Tabet) Oedema Peripheral Health (Risperidone) PS ORAL 3 MG, DAILY, Thrombocytopenia Professional ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS Biperiden Hyrdochloride (Biperiden Hydrochloride) C Pantethine (Pantethine) C Date:03/20/03ISR Number: 4080144-7Report Type:Expedited (15-DaCompany Report #EMADSS2003002191 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Risperdal (2 Mg Atrioventricular Block Health Tablet) Sinus Arrest Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Seropam (Citalopram Hydrobromide) C Xanor (Alprazolam) C Temesta (Lorazepam) C 22-Feb-2006 08:20 AM Page: 1567 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/03ISR Number: 4080145-9Report Type:Expedited (15-DaCompany Report #APCDSS2003000381 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Risperidone Dysphagia Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Zopiclone (Zopiclone) C Donepezil Hydrochloride (Donepezil Hydrochloride) C Date:03/20/03ISR Number: 4080146-0Report Type:Expedited (15-DaCompany Report #EMADSS2003002183 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Unspecified) Professional (Risperdone) PS ORAL SEE IMAGE Seroquel (Seroquel) SS ORAL SEE IMAGE Depakine (Valproate Sodium) SS ORAL SEE IMAGE Zoloft (Sertraline Hydrochloride) SS ORAL 50 MG, DAILY, ORAL Date:03/20/03ISR Number: 4080147-2Report Type:Expedited (15-DaCompany Report #EMADSS2003000517 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Risperdal Initial or Prolonged Fall Health (Risperidone) PS 1 MG; 9 MG, Required Loss Of Consciousness Professional DAILY Intervention to Medication Error Deroxat (Paroxetine Prevent Permanent Meningioma Hydrochloride) SS 10 MG, DAILY Impairment/Damage Pleural Effusion Zyprexa (Olanzapine) SS 10 MG, DAILY Rib Fracture Temesta (Lorazepam) SS 2 MG, DAILY Suicidal Ideation Date:03/20/03ISR Number: 4080148-4Report Type:Expedited (15-DaCompany Report #APCDSS2002001569 Age:73 YR Gender:Female I/FU:F Outcome PT Death Acidosis Hospitalization - Anxiety Initial or Prolonged Arrhythmia Atrial Fibrillation Blood Pressure Abnormal Condition Aggravated Depressed Level Of Consciousness Hypercapnia Hypoxia Mitral Valve Incompetence Respiratory Depression Respiratory Failure 22-Feb-2006 08:20 AM Page: 1568 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Report Source Product Role Manufacturer Route Dose Duration Foreign Risperidone Health (Risperidone) PS ORAL 3 MG, DAILY, Professional ORAL; 2 MG, DAILY, ORAL; 1 MG DAILY, ORAL Trihexyphenidyl Hydrochloride (Trihexyphendiyl Hydrochloride) C Trapidil (Trapidil) C Ubidecarenone (Ubidecarenone) C Sennoside (Sennosides) C Potassium Chloride (Potassium Chloride) C Date:03/20/03ISR Number: 4080452-XReport Type:Expedited (15-DaCompany Report #NSADSS2003011825 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Consumer Risperdal (Tablet) Hospitalization - (Risperidone) PS 0.75 MG - 1 Initial or Prolonged MG DAILY Celexa (Citalopram Hydrobromide) C Depakote (Valproate Semisodium) C Benadryl (Diphenhydrochloride ) C Insulin C Aspirin (Acetylsalicylic Acid) C Date:03/20/03ISR Number: 4080453-1Report Type:Expedited (15-DaCompany Report #NSADSS2002015031 Age:8 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypoglycaemic Seizure Health Risperdal Professional (Risperidone) PS ORAL 0.25 MG, PRN, ORAL Humalog (Insulin Lispro) C Nph (Insulin) C 22-Feb-2006 08:20 AM Page: 1569 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/20/03ISR Number: 4080528-7Report Type:Expedited (15-DaCompany Report #APCDSS2003000394 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Cirrhosis Foreign Risperidone Leukopenia Health (Unspecified) Platelet Count Decreased Professional Risperidone PS ORAL 6 MG, DAILY, ORAL Etizolam (Etizolam) SS ORAL 3 MG, DAILY, ORAL Date:03/20/03ISR Number: 4080576-7Report Type:Expedited (15-DaCompany Report #L02-USA-03743-18 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Citalopram Hospitalization - Drug Screen Positive Health (Citalopram Initial or Prolonged Heart Rate Increased Professional Hydrobromide) PS Hypotension Risperidone SS Intentional Overdose Perphenazine SS Lethargy Tricyclics Nos C Respiratory Disorder Benzodiazepines Nos C Date:03/20/03ISR Number: 4080825-5Report Type:Expedited (15-DaCompany Report #MO260-2003 Age:77 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Mirtazapine PS ORAL 15 MG/30 Initial or Prolonged Increased Professional MG/45 MG 8 DAY Aspartate Risperidone SS ORAL 1 MG/1.5 MG 10 DAY Aminotransferase Donepezil Increased Hydrochloride C Blood Bilirubin Increased Metoprolol Succinate C Blood Lactate Prothipendyl Dehydrogenase Increased Hydrochloride C Hepatic Steatosis Platelet Count Abnormal Date:03/21/03ISR Number: 4081871-8Report Type:Expedited (15-DaCompany Report #1670009A Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anoxic Encephalopathy Foreign Unspecified Initial or Prolonged Depressed Level Of Literature Loperamide Consciousness Health Hydrochloride Dyspnoea Professional Product PS ORAL 2 DAILY, PO 2 DAY Pulmonary Embolism Risperidone SS ORAL 2 MG, DAILY, Pulse Absent PO 6 DAY Phenytoin, Convulsions SS ORAL 300 MG DAILY, PO Maalox, Stomach Upset SS 30 ML DAILY, Unspecified Benzodiazepine C 22-Feb-2006 08:20 AM Page: 1570 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/03ISR Number: 4081875-5Report Type:Expedited (15-DaCompany Report #NSADSS2003012694 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:03/21/03ISR Number: 4081943-8Report Type:Expedited (15-DaCompany Report #HQWYE975311MAR03 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Study Inderal (Propranolol Initial or Prolonged First Degree Literature Hydrochloride, Blood Pressure Systolic Tablet) PS "OVERDOSE" Decreased Risperidone Cardiotoxicity (Risperidone) SS Electrocardiogram Pr Sertraline SS Prolongation Overdose Date:03/21/03ISR Number: 4082013-5Report Type:Expedited (15-DaCompany Report #2002AP04514 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Foreign Seroquel PS ORAL 75 MG DAILY Hospitalization - Diabetic Hyperosmolar Health PO Initial or Prolonged Coma Professional Prednisolone Acetate SS ORAL 20 MG DAILY Drug Interaction Other PO Hepatic Function Abnormal Risperidone SS ORAL 2 MG DAILY PO Risperidone SS ORAL 3 MG DAILY PO Chlorpromazine C Levomepromazine C Haloperidol C Artane C Brovarin C Isomytal C Date:03/21/03ISR Number: 4082142-6Report Type:Expedited (15-DaCompany Report #APCDSS2003000394 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Cirrhosis Foreign Risperidone Leukopenia Health (Unspecified) Professional (Risperidone) PS OPHTHALMIC 6 MG, DAILY, ORAL Etizolam SS ORAL 3 MG, DAILY, ORAL Date:03/21/03ISR Number: 4082143-8Report Type:Expedited (15-DaCompany Report #EMADSS2003002182 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Atrophy Foreign Risperdal Initial or Prolonged Parkinsonism Health (Unspecified) Professional (Risperidone) PS ORAL 8 MG, 2 IN 1 DAY(S), ORAL Ass (Acetylsalicylic 22-Feb-2006 08:20 AM Page: 1571 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acid) C Xanef (Enalapril Maleate) C Akatinol Memantine (Memantine Hydrochloride) C Date:03/21/03ISR Number: 4082144-XReport Type:Expedited (15-DaCompany Report #EMADSS2003002256 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, DAILY, Company ORAL Representative Date:03/21/03ISR Number: 4082157-8Report Type:Expedited (15-DaCompany Report #APCDSS2003000341 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorectal Disorder Foreign Haldol (Tablet) Depression Health (Haloperidol) PS ORAL 6.75 MG, Drug Ineffective Professional DAILY, ORAL Insomnia Haldol (Injection) Intentional Self-Injury (Haloperidol) SS INTRAMUSCULAR 5 MG, DAILY, Laceration IM Suicidal Ideation Risperdal (Tablet) (Risperidone) SS ORAL 3 MG, DAILY, ORAL Milnacipran Hydrochloride (Milnacipran) SS ORAL 45 MG, DAILY, ORAL Etizolam (Etizolam) C Estazolam (Estazolam) C Flunitrazepam (Flunitrazepam) C Triazolam (Triazolam) C Amoxapine (Amoxapine) C Thioridzine Hydrochloride (Thioridazine Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:03/21/03ISR Number: 4082162-1Report Type:Expedited (15-DaCompany Report #DEWYE034224FEB03 Age:53 YR Gender:Female I/FU:I Outcome PT Hospitalization - Akinesia Initial or Prolonged Bowel Sounds Abnormal Intentional Overdose 22-Feb-2006 08:20 AM Page: 1572 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mydriasis Tachycardia Tremor Report Source Product Role Manufacturer Route Dose Duration Health Trevilor Retard Professional (Venlafaxine Hydrochloride, Capsule, Extended Release,0) PS ORAL 30 TABLETS (OVERDOSE AMOUNT 4500 MG) 1 DAY Efexor (Venlafaxine Hydrochloride, Unspec,0) SS ORAL 50 TABLETS (OVERDOSE AMOUNT 3750 MG) Risperdal (Risperidone,0) SS ORAL 10 TABLETS (OVERDOSE AMOUNT 20 MG) 1 DAY Date:03/24/03ISR Number: 4082273-0Report Type:Expedited (15-DaCompany Report #NSADSS2003012357 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Risperdal Initial or Prolonged Drug Interaction Health (Unspecified) Professional (Risperidone) PS ORAL 3 MG, DAILY, Company ORAL Representative Efexor Cpr (Venlafaxine Hydrochloride) SS 150 MG, DAILY Sinemet (Sinemet) C Seroquel (Seroquel) C Zyprexa (Olanzapine) C Geodon C Date:03/24/03ISR Number: 4082275-4Report Type:Expedited (15-DaCompany Report #EMADSS2003002334 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Risperdal Initial or Prolonged Femoral Neck Fracture Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG, ORAL Bendrofluazide (Bendroflutmethazide ) C Frumil (Frumil) C Digoxin (Digoxin) C Date:03/24/03ISR Number: 4082396-6Report Type:Expedited (15-DaCompany Report #EMADSS2003001520 Age: Gender:Female I/FU:F Outcome PT Hospitalization - Blood Creatinine Initial or Prolonged Blood Potassium Blood Pressure 22-Feb-2006 08:20 AM Page: 1573 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Sodium Blood Urea Body Temperature Report Source Product Role Manufacturer Route Dose Duration Inappropriate Foreign Risperdal Antidiuretic Hormone Health (Unspecified) Secretion Professional (Risperidone) PS ORAL Rhabdomyolysis Promethazine Somnolence (Promethazine) C Suicide Attempt Temazepam (Temazepam) C Nortrilen (Nortriptyline Hydrochloride) C Lorazepam (Lorazepam) C Haloperidol (Haloperidol) C Date:03/24/03ISR Number: 4082432-7Report Type:Expedited (15-DaCompany Report #EMADSS2003002179 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pleural Effusion Foreign Risperidone Health (Solution) Professional (Risperidone) PS ORAL 0.75 MG, 2 IN 1 DAILY, ORAL Beta Blocking Agents (Beta Blocking Agents) C Marcumor (Phenprocoumon) C Nitrate C Date:03/24/03ISR Number: 4082466-2Report Type:Expedited (15-DaCompany Report #NSADSS2003013478 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adenocarcinoma Foreign Risperidone Initial or Prolonged Endometrial Cancer Literature (Unspecified) Required Health (Risperidone) PS ORAL 2 MG, DAILY, Intervention to Professional ORAL 6 YR Prevent Permanent Chlorpromazine Impairment/Damage (Chloropromazine) SS 37.5 MG, DAILY Date:03/24/03ISR Number: 4082704-6Report Type:Expedited (15-DaCompany Report #NSADSS2003009901 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Health Risperdal Professional (Unspecified) (Risperidone) PS 22-Feb-2006 08:20 AM Page: 1574 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/03ISR Number: 4082705-8Report Type:Expedited (15-DaCompany Report #NSADSS2001021958 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:03/24/03ISR Number: 4082744-7Report Type:Expedited (15-DaCompany Report #DEWYE034224FEB03 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Health Trevilor Retard Initial or Prolonged Bowel Sounds Abnormal Professional (Venlafaxine Drug Toxicity Hydrochloride, Intentional Overdose Capsule, Extended Mydriasis Release, 0) PS ORAL 30 TABLETS Tachycardia (OVERDOSE Tremor AMOUNT 4500MG), ORAL 1 DAY Risperdal (Risperidone, , 0) SS ORAL 10 TABLETS (OVERDOSE AMOUNT 20MG), ORAL 1 DAY Trevilor (Venlafaxine Hydrochloride, Unspec, 0) SS ORAL 50 TABLETS (3750MG); ORAL 1 DAY Date:03/24/03ISR Number: 4082854-4Report Type:Expedited (15-DaCompany Report #2002-01825 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Foreign Loxitane Im Initial or Prolonged Health (Loxapac)(Loxapine Professional Hydrochloride) Company Injection, 50 Mg/Ml PS INTRAMUSCULAR 150 MG, Representative SINGLE, Other INTRAMUSCULAR Nozinan(Levomepromaz ine) SS ORAL 100 GTT, SINGLE, ORAL Risperidal(Risperido ne) Tablet SS ORAL 1 TABLET, DAILY, ORAL Terrcian(Cyamemazine SS ORAL 120 GTT, DAILY, ORAL Zyprexa(Olanzapine) Tablet SS ORAL 2 TABLET, DAILY, ORAL Imovane (Zopiclone) C Lepticur (Tropatepine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1575 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/03ISR Number: 4083395-0Report Type:Expedited (15-DaCompany Report #EMADSS2003001129 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Risperdal Initial or Prolonged Condition Aggravated Health (Unspecified) Epistaxis Professional (Risperidone) PS ORAL 3 MG, DAILY, Headache Other ORAL Hyperaldosteronism Tercain Hypoaesthesia (Cyamemazine) SS ORAL SEE IMAGE Phosphenes Deroxat (Paroxetine Proteinuria Hydrochloride) SS ORAL 20 MG, DAILY, Renal Atrophy ORAL Tachycardia Tremor Date:03/25/03ISR Number: 4083763-7Report Type:Expedited (15-DaCompany Report #S03-GER-001172-01 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Cipramil (Citalopram Initial or Prolonged Drug Level Increased Health Hydrobromide) PS ORAL 20 MG QD PO Grand Mal Convulsion Professional Cipramil (Citalopram Overdose Other Hydrobromide) SS ORAL 40 MG QD PO Cipramil (Citalopram Hydrobromide) SS ORAL 20 MG QD PO Risperdal (Risperidone) SS ORAL 3 MG QD PO Risperdal (Risperidone) SS ORAL 2 MG QD PO Theophyllin (Theophylline) SS ORAL 600 MG PO Theophyllin (Theophylline) SS ORAL 500 MG QD PO Verapamil C Foradil (Formoterol Fumarate) C Fluctin (Fluoxetine Hydrochloride) C Date:03/25/03ISR Number: 4084465-3Report Type:Direct Company Report #CTU 189474 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Haloperidol PS 5MG TID Intervention to Risperidone SS 2-6 MG /DAY Prevent Permanent Benztropine C Impairment/Damage L-Thyroxine C Quetiapine C Ziprasidone C Olanzapine C Date:03/26/03ISR Number: 4083471-2Report Type:Expedited (15-DaCompany Report #NSADSS2002011265 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Risperdal (3 Mg Drug Toxicity Professional Tablet) (Risperidone) PS ORAL 3MG, DAILY, 22-Feb-2006 08:20 AM Page: 1576 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Lamictal (Lamotrigine) C Wellbutrin (Amfebutamone Hydrochloride) C Date:03/26/03ISR Number: 4083472-4Report Type:Expedited (15-DaCompany Report #NSADSS2003012922 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2MG, 1 IN DAILY, ORAL Date:03/26/03ISR Number: 4083512-2Report Type:Expedited (15-DaCompany Report #NSADSS2003013316 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 1 MG, 3 IN 24 HOUR (S), ORAL Potassium (Potassium) C Serzone (Nefazodone Hydrochloride) C Lanoxin (Digoxin) C Maxzide (Dyazide) C Milk Of Magnesia (Magnesium Hydroxide) C Multi Vitamin C Date:03/26/03ISR Number: 4084250-2Report Type:Expedited (15-DaCompany Report #HQWYE815503MAR03 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Health Efexor Exel Hospitalization - Agitation Professional (Venlafaxine Initial or Prolonged Attention Hydrochloride, Deficit/Hyperactivity Capsule, Extended Disorder Release) PS ORAL 75 MG 1X PER Communication Disorder 1 DAY, ORAL 28 DAY Distractibility Dominal Eye Movement Disorder (Prothipendyl Inappropriate Hydrochloride) SS ORAL 40 MG 1X PER Antidiuretic Hormone 1 DAY, ORAL Secretion Risperdal Muscle Spasms (Risperidone) SS 4 MG 1X PER 1 Speech Disorder DAY 55 DAY Zyprexa (Olanzapine) SS 5 MG (1/2 TABLET) 22 DAY Loramet (Lormetazepam) C Zantac (Ranitidine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1577 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Xanax (Alprazolam) C Lysanxia (Prazepam) C Voltaren (Diclofenac Sodium) C Dafalgan (Paracetamol) C Sodium Chloride C Ferro-Gradumet (Ferrous Sulfate) C Kemadren (Procyclidine Hydrochloride) C Fragmin (Heparin-Fraction, Sodium Salt) C Betnelan (Betamethasone) C Date:03/26/03ISR Number: 4084308-8Report Type:Expedited (15-DaCompany Report #EMADSS2003001676 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Influenza Foreign Risperdal (3 Mg Leukopenia Health Tablet (Risperidone) PS ORAL 3 MG, DAILY, Neutropenia Professional ORAL Akineton (Biperiden Hydrochloride) C Tavor (Lorazepam) C Cipramil (Citalopram) C Date:03/26/03ISR Number: 4084313-1Report Type:Expedited (15-DaCompany Report #EMADSS2003002298 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Pyrexia Health (Unspecified) Professional (Risperidone) PS ORAL ORAL Company Representative Date:03/27/03ISR Number: 4086980-5Report Type:Expedited (15-DaCompany Report #EMADSS2003002459 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Terican (Cyamemazine) SS Date:03/27/03ISR Number: 4086981-7Report Type:Expedited (15-DaCompany Report #APCDSS2003000397 Age:68 YR Gender:Female I/FU:F Outcome PT Hospitalization - Haemorrhage Initial or Prolonged Oedema Peripheral 22-Feb-2006 08:20 AM Page: 1578 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thrombocytopenia Report Source Product Role Manufacturer Route Dose Duration Foreign Risperidone (Tablet) Health (Risperidone) PS ORAL 3 MG, DAILY, Professional ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS ORAL 62.5 MG, DAILY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Pantethine (Pantethine) C Date:03/28/03ISR Number: 4084271-XReport Type:Direct Company Report #CTU 189762 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tongue Oedema Risperidone PS 1 MG BID Tongue Paralysis Mirtazapine C Date:03/28/03ISR Number: 4084416-1Report Type:Direct Company Report #CTU 189754 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breath Sounds Abnormal Risperidone PS 1 MG BID Dyspnoea Fluoxetine C Speech Disorder Tongue Oedema Vomiting Date:03/28/03ISR Number: 4087654-7Report Type:Expedited (15-DaCompany Report #EMADSS2003002426 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Durogesic (Patch) Initial or Prolonged Hypertonia Health (Fentanyl) PS TRANSDERMAL TRANSD Pyrexia Professional Risperdal (Unspecified) (Risperidone) SS ORAL ORAL Seropram (Citalopram Hydrobromide) SS ORAL ORAL Lenitral (Glyceryl Trinitrate) C Vastarel (Trimetazidine Dihydrochloride) C Imovane (Zopiclone) C 22-Feb-2006 08:20 AM Page: 1579 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/03ISR Number: 4082582-5Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0292231A Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Aldosterone Deroxat PS Glaxosmithkline ORAL 20MG Per day 25 DAY Initial or Prolonged Increased Risperdal SS ORAL 3MG Per day 5 DAY Other Drug Interaction Tercian SS ORAL Epistaxis Zyprexa C ORAL Headache Lexomil C ORAL 3MG Per day 7 DAY Hypertension Hypoaesthesia Kidney Small Phosphenes Renin Increased Tachycardia Date:04/01/03ISR Number: 4084902-4Report Type:Direct Company Report #CTU 189924 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthma Risperdal PS 2.3 MG DAILY Hospitalization - Blood Pressure Decreased PILL Initial or Prolonged Body Temperature Zyprexa SS 20 MG, 10MG, Disability Decreased 2.5MG PILL Other Cerebrovascular Accident Zoloft SS 100 MG, 50 Required Coma MG, 25 MG Intervention to Convulsion Effexor SS Prevent Permanent Cyst Elavil SS Impairment/Damage Encephalomalacia Tegretol C Extrapyramidal Disorder Depakote C Fungal Infection Gabitril C Gastrooesophageal Reflux Claritin C Disease Synthroid C Haematoma Advair Discus C Heart Rate Increased Keppra C Hypothyroidism Felbamate C Joint Stiffness Zonegran C Ovarian Disorder Prevacid C Pain Allegra C Psychomotor Hyperactivity Lodine Xl C Rash Flonase C Rhinitis Ativan C Scleroderma Cogentin C Skin Lesion Amantadine C Sleep Apnoea Syndrome Benadryl C Status Epilepticus Clonopin C Syncope Haldol C Uterine Disorder Seroquel C Visual Disturbance Elavil C Weight Decreased Effexor C Date:04/01/03ISR Number: 4085459-4Report Type:Expedited (15-DaCompany Report #EMADSS2003001125 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Foreign Risperdal Study (Unspecified) Health (Risperidone) PS ORAL 2 MG, 3 IN 1 Professional DAY(S); ORAL Nifedipine C 22-Feb-2006 08:20 AM Page: 1580 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acetylsalicylic Acid C Selegiline C Date:04/01/03ISR Number: 4085467-3Report Type:Expedited (15-DaCompany Report #APCDSS2003000194 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Risperidone (Tablet) Initial or Prolonged Aspartate Health (Risperidone) PS ORAL SEE IMAGE Aminotransferase Professional Donepezil Increased Hydrochloride Automatism (Donepezil Blood Creatine Hydrochloride) SS ORAL 5 MG, DAILY, Phosphokinase Increased ORAL Cerebral Infarction Meclofenoxate Circadian Rhythm Sleep Hydrochloride Disorder (Meclofenoxate Delusion Hydrochloride) C Hallucination, Visual Tamsulosin Hemiparesis Hydrochloride Hepatic Function Abnormal (Tamsulosin Pneumonia Aspiration Hydrochloride) C Supraventricular Extrasystoles Date:04/01/03ISR Number: 4085468-5Report Type:Expedited (15-DaCompany Report #EMADSS2003002514 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 9 MG, DAILY, ORAL Date:04/01/03ISR Number: 4085469-7Report Type:Expedited (15-DaCompany Report #EMADSS2003002459 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Tercian (Cyamemazine) SS Date:04/01/03ISR Number: 4085522-8Report Type:Expedited (15-DaCompany Report #NSADSS2003014612 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Consumer Risperdal Diabetes Mellitus (Unspecified) Myocardial Infarction (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1581 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/03ISR Number: 4085523-XReport Type:Expedited (15-DaCompany Report #NSADSS2003014607 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Ischaemia Health Risperdal Professional (Unspecified) (Risperidone) PS Date:04/01/03ISR Number: 4085524-1Report Type:Expedited (15-DaCompany Report #NSADSS2003014188 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:04/01/03ISR Number: 4085525-3Report Type:Expedited (15-DaCompany Report #NSADSS2003014128 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:04/01/03ISR Number: 4085526-5Report Type:Expedited (15-DaCompany Report #NSADSS2003014597 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:04/01/03ISR Number: 4085527-7Report Type:Expedited (15-DaCompany Report #NSADSS2003014601 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:04/01/03ISR Number: 4085528-9Report Type:Expedited (15-DaCompany Report #NSADSS2003014605 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:04/01/03ISR Number: 4085529-0Report Type:Expedited (15-DaCompany Report #NSADSS2003006733 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Coma Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, 2 IN 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 1582 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel (Seroquel) C Depakote (Valproate Semisodium) C Date:04/01/03ISR Number: 4085558-7Report Type:Expedited (15-DaCompany Report #HQWYE259926MAR03 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Extrapyramidal Disorder Foreign Efexor Er Other Health (Venlafaxine Professional Hydrochloride, Capsule, Extended Release) PS ORAL 75 MG 1X PER 1 DAY ORAL Risperdal (Risperidone,) SS ORAL 0.25 MG 1X PER 1 DAY ORAL 3 MON Date:04/02/03ISR Number: 4088272-7Report Type:Expedited (15-DaCompany Report #NSADSS2003014297 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, 2 IN DAILY, ORAL Date:04/03/03ISR Number: 4089099-2Report Type:Expedited (15-DaCompany Report #EMADSS2003002618 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Risperidone) PS ORAL 1 MG, ORAL 2 WK Professional Date:04/03/03ISR Number: 4089517-XReport Type:Expedited (15-DaCompany Report #NSADSS2003008279 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Stroke Health Risperdal (1 Mg Hypertension Professional Tablet) Treatment Noncompliance (Risperidone) PS ORAL 1 MG, DAILY, Ventricular Hypertrophy ORAL Prozac (Fluoxetine Hydrochloride) C Date:04/03/03ISR Number: 4089519-3Report Type:Expedited (15-DaCompany Report #NSADSS2003007276 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Risperdal Dementia Alzheimer'S Type Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1583 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/03/03ISR Number: 4089520-XReport Type:Expedited (15-DaCompany Report #NSADSS2003014805 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:04/03/03ISR Number: 4089786-6Report Type:Expedited (15-DaCompany Report #EMADSS2003002312 Age:99 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Failure Foreign Risperidone(Unspecif Study ied) (Risperidone) PS ORAL 1 MG, 2 IN 1 Health DAY(S), ORAL Professional Enalapril(Enalapril) C Nitroglycerine (Glyceryl Trinitrate) C Date:04/04/03ISR Number: 4090330-8Report Type:Expedited (15-DaCompany Report #APCDSS2002000428 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Anomaly Of External Ear Foreign Risperdal Congenital Health (Unspecified) Chondrodystrophy Professional (Risperidone) PS INTRA-UTERINE 4 MG DAILY, Complications Of Maternal UTERINE Exposure To Therapeutic Carbamazepine Drugs (Carbamazepine) SS INTRA-UTERINE 400 MG DAILY, Maternal Drugs Affecting UTERINE Foetus Trihexyphenidyl Pregnancy Hydrochloride Vacuum Extractor Delivery (Trihexyphenidyl Hydrochloride) SS INTRA-UTERINE 4 MG DAILY UTERINE Date:04/04/03ISR Number: 4090536-8Report Type:Expedited (15-DaCompany Report #APCDSS2003000294 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Risperdal Arrhythmia Consumer (Unspecified) Blood Alkaline Health (Risperidone) PS GRADUALLY Phosphatase Professional INCREASED TO Blood Urea 2 MG MANE AND Circulatory Collapse 3 MG NOCTE Myocardial Ischaemia Irbesartan / Rash Maculo-Papular Hydrochlorothiazide Tremor (Irbesartan/Hydrochl orothiazide) C Epilim (Valproate Sodium) C Aspirin (Acetylsalicylic Acid) C 22-Feb-2006 08:20 AM Page: 1584 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/03ISR Number: 4091395-XReport Type:Expedited (15-DaCompany Report #EMADSS2003002491 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Risperidone Study (Unspecified) Health (Risperidone) PS 2 MG, 2 IN 1 Professional DAY (S) Disgren (Triflusal) C Theodur Neo (Theophylline) C Capoten (Captopril) C Digoxin (Digoxin) C Seguril (Furosemide) C Fluimucil (Acetylcysteine) C Date:04/08/03ISR Number: 4091397-3Report Type:Expedited (15-DaCompany Report #EMADSS2003002319 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Risperidone Study (Unspecified) Health (Risperidone) PS 0.5 MG, DAILY Professional Almax (Almagate) C Analgesics (Analgesics) C Date:04/08/03ISR Number: 4091862-9Report Type:Expedited (15-DaCompany Report #APCDSS2003000479 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperidone PS ORAL 6 MG, DAILY, Health ORAL Professional Levomepromazine Other Maleate C Biperiden Hydrochloride C Lorazepam C Date:04/08/03ISR Number: 4091884-8Report Type:Expedited (15-DaCompany Report #EMADSS2003002698 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Pulmonary Oedema Foreign Risperdal (Solution) Initial or Prolonged Extrapyramidal Disorder Health (Risperidone) PS ORAL DAILY, ORAL Hyperhidrosis Professional Aricept (Donepezil Hypotension Hydrochloride) C Malaise Equanil Vomiting (Meprobamate) C Imovane (Zopiclone) C Date:04/08/03ISR Number: 4092196-9Report Type:Expedited (15-DaCompany Report #NSADSS2003008536 Age:40 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 1585 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Galactorrhoea Health Risperdal(Tablet) Pituitary Tumour Professional (Risperidone) PS ORAL ORAL Prolactinoma Company L-Thyroxine Representative (Levothyroxine Sodium) C Prozac (Fluoxetine Hydrochloride) C Topamax C Ritalin Sr (Methylphenidate Hydrochloride) C Wellbutrin Sr (Amfebutamone Hydrochloride) C Neurontin (Gabapentin) C Date:04/09/03ISR Number: 4087784-XReport Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040772A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Overdose Quilonum Retard PS Glaxosmithkline ORAL 900MG per day HR Suicide Attempt Atarax SS ORAL 50MG per day HR Dipiperon SS ORAL 320MG per day HR Fluoxetin SS ORAL 60MG per day HR Risperdal SS ORAL 6MG per day HR Date:04/09/03ISR Number: 4092583-9Report Type:Expedited (15-DaCompany Report #EMADSS2003002179 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bronchopneumonia Foreign Risperidone Oedema Health (Solution) Pleural Effusion Professional (Risperidone) PS ORAL 0.75 MG, 2 IN 1 DAILY, ORAL Beta Blocking Agents (Beta Blocking Agents) C Marcumar (Phenprocoumon) C Nitrate C Date:04/09/03ISR Number: 4092717-6Report Type:Expedited (15-DaCompany Report #NSADSS2003016036 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS 22-Feb-2006 08:20 AM Page: 1586 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/03ISR Number: 4092718-8Report Type:Expedited (15-DaCompany Report #NSADSS2003016032 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL 5 MG, 2 IN 24 HOUR(S), ORAL Date:04/09/03ISR Number: 4092720-6Report Type:Expedited (15-DaCompany Report #NSADSS2002008899 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Intentional Overdose Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS TOOK APPROX 60 TAB AT ONCE Date:04/10/03ISR Number: 4091723-5Report Type:Direct Company Report #CTU 190626 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Risperdal PS ORAL Initial or Prolonged Corrected Interval Effexor C Prolonged Hypokalaemia Hyponatraemia Hypotension Lethargy Overdose Sedation Tachycardia Date:04/10/03ISR Number: 4093598-7Report Type:Expedited (15-DaCompany Report #APCDSS2002001273 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Haldol Completed Suicide Health (Tablet)(Haloperidol Delusion Professional ) PS ORAL 18 MG, DAILY, Disturbance In Attention ORAL; 9 MG, Fatigue DAILY, ORAL Hallucination, Auditory Risperidone(Tablet)( Malaise Risperidone) SS ORAL 4 MG, DAILY, Muscle Rigidity ORAL Somnolence Trihexyphenidyl Suicide Attempt Hydrochloride(Trihex Treatment Noncompliance yphenidyl Hydrochloride) C Biperiden Hydrochloride(Biperi den Hydrochloride) C Chlorpromazine Hydrochloride(Chlorp romazine Hydrochloride) C Bromazepam(Bromazepa m) C 22-Feb-2006 08:20 AM Page: 1587 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Estazolam(Estazolam) C Brotizolam(Brotizola m) C Date:04/10/03ISR Number: 4093603-8Report Type:Expedited (15-DaCompany Report #APCDSS2003000504 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Risperidone(Tablet)( Hospitalization - Cardio-Respiratory Arrest Health Risperidone) PS ORAL 2 MG, DAILY, Initial or Prolonged Loss Of Consciousness Professional ORAL Required Multi-Organ Failure Etizolam (Etizolam) C Intervention to Prothrombin Time Nitrazepam(Nitrazepa Prevent Permanent Prolonged m) C Impairment/Damage Treatment Noncompliance Date:04/10/03ISR Number: 4093827-XReport Type:Expedited (15-DaCompany Report #NSADSS2003016521 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Health Risperdal Breast Cancer Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:04/10/03ISR Number: 4093830-XReport Type:Expedited (15-DaCompany Report #NSADSS2002023946 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Mass Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL 0.125 MG, 1 IN 1 NIGHT (S), ORAL Lipitor (Atorvastatin) C Paxil (Paroxetine Hydrochloride) C Date:04/10/03ISR Number: 4093833-5Report Type:Expedited (15-DaCompany Report #NSADSS2003015695 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:04/10/03ISR Number: 4093905-5Report Type:Expedited (15-DaCompany Report #NSADSS2003015591 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Consumer Risperdal (1 Mg Myocardial Infarction Tablet) (Risperidone) PS ORAL 1 MG, 2 IN 24 HOUR(S), ORAL 22-Feb-2006 08:20 AM Page: 1588 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/10/03ISR Number: 4093907-9Report Type:Expedited (15-DaCompany Report #NSADSS2003015708 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Risperdal Head Injury Professional (Unspecified) Subdural Haematoma (Risperidone) PS ORAL ORAL Date:04/10/03ISR Number: 4093909-2Report Type:Expedited (15-DaCompany Report #NSADSS2003015702 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (1 Mg Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 24 YEAR(S), ORAL Date:04/10/03ISR Number: 4093910-9Report Type:Expedited (15-DaCompany Report #NSADSS2003015686 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:04/10/03ISR Number: 4094047-5Report Type:Expedited (15-DaCompany Report #B0295904A Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Paxil (Formulation Hospitalization - Serotonin Syndrome Health Unknown) (Paroxetine Initial or Prolonged Professional Hydrochloride) PS Risperidone (Formulation Unknown) (Risperidone) SS Date:04/10/03ISR Number: 4096302-1Report Type:Expedited (15-DaCompany Report #A0403463A Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Foreign Paxil (Formulation Drug Withdrawal Syndrome Literature Unknown) (Paroxetine Gait Disturbance Health Hydrochloride) PS ORAL 20 MG/ PER Headache Professional DAY/ ORAL Hyperhidrosis Risperidone Malaise (Formulation Unknown) (Risperidone) SS ORAL ORAL Aspirin C Nitroglycerine C 22-Feb-2006 08:20 AM Page: 1589 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/10/03ISR Number: 4096308-2Report Type:Expedited (15-DaCompany Report #A0403283A Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Paxil (Formulation Phosphokinase Increased Literature Unknown) (Paroxetine Dizziness Health Hydrochloride) PS ORAL 30 MG/ PER Drug Withdrawal Syndrome Professional DAY/ ORAL Dyskinesia Oxazepam Headache (Formulation Hyperhidrosis Unknown) (Oxazepam) SS ORAL 15 MG/ PER Hyperreflexia DAY/ ORAL Nausea Risperidone Tremor (Formulation Unknown) (Risperidone) SS ORAL 6 MG/ PER DAY/ ORAL Thyroxine Sodium C Date:04/11/03ISR Number: 4094141-9Report Type:Expedited (15-DaCompany Report #NSADSS2002045684 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal(Risperidon Professional e) PS ORAL 1 MG, 2 IN 1 DAY(S), ORAL Geodon C Seroquel (Seroquel) C Date:04/11/03ISR Number: 4094206-1Report Type:Expedited (15-DaCompany Report #NSADSS2003016732 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Muscle Rigidity Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN 24 HOUR(S), ORAL Aricept (Donepezil Hydrochloride) C Date:04/11/03ISR Number: 4094207-3Report Type:Expedited (15-DaCompany Report #NSADSS2003016690 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Failure Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN 24 HOUR(S), ORAL Aricept (Donepezil Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1590 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/03ISR Number: 4094208-5Report Type:Expedited (15-DaCompany Report #NSADSS2003016718 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN 24 HOUR(S), ORAL Aricept (Donepezil Hydrochloride) C Date:04/11/03ISR Number: 4094237-1Report Type:Expedited (15-DaCompany Report #NSADSS2001023762 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MGH, 1 IN 1 NIGHT(S), ORAL Neurontin (Gabapentin) C Date:04/11/03ISR Number: 4094352-2Report Type:Expedited (15-DaCompany Report #EMADSS2003002831 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperidone (Tablet) Initial or Prolonged Drug Level Below Health (Risperidone) PS ORAL 4 MG, DAILY, Therapeutic Professional ORAL Schizoaffective Disorder Risperidone Therapeutic Response (Microspheres) Decreased (Risperidone) SS INTRAMUSCULAR 37.5 MG, 1 IN Treatment Noncompliance 2 WEEK (S), IM Date:04/11/03ISR Number: 4094353-4Report Type:Expedited (15-DaCompany Report #EMADSS2003002816 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Foreign Risperdal (1 Mg Health Tablet) Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY (S), ORAL Date:04/14/03ISR Number: 4091783-1Report Type:Direct Company Report #CTU 190783 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Risperdal 0.5mg Required Jannsen PS Jannsen ORAL 0.5MG ONCE Intervention to DAILY ORAL Prevent Permanent Effexor C Impairment/Damage Nortryptiline C Trazodone C Clonazepam C Cytomel C 22-Feb-2006 08:20 AM Page: 1591 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Allegra D C Doxycycline 100mg C Date:04/14/03ISR Number: 4091788-0Report Type:Direct Company Report #CTU 190858 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Neutropenia Depakote 250mg PS ORAL 250MG TID Intervention to ORAL Prevent Permanent Risperdal 3mg SS ORAL 3MG HS ORAL Impairment/Damage Date:04/14/03ISR Number: 4094708-8Report Type:Expedited (15-DaCompany Report #EMADSS2003002919 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal (6 Mg Health Tablet) Professional (Risperidone) PS ORAL 6MG, DAILY, ORAL Depakote (Valproate Semisodium) C Lepticur (Tropatepine Hydrochloride) C Parlodel (Bromocriptine Mesilate) C Date:04/14/03ISR Number: 4094894-XReport Type:Expedited (15-DaCompany Report #EMADSS2003002975 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ischaemic Stroke Foreign Reminyl Initial or Prolonged Health (Unspecified) Professional (Galantamine) PS ORAL 16 MG, DAILY, ORAL Risperdal (Unspecified) (Risperidone) SS ORAL 0.5 MG, 1 IN 1 DAY(S), ORAL Lopressor (Metoprolol Tartrate) SS ORAL 200 MG, 1 IN 1 DAY(S), ORAL Ebixa (Memantine Hydrochloride) SS ORAL 5 MG, 1 IN 1 DAY(S), ORAL Imovane (Zopiclone) SS ORAL 7.5 MG, 1 IN 1 DAY(S), ORAL 22-Feb-2006 08:20 AM Page: 1592 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/03ISR Number: 4094895-1Report Type:Expedited (15-DaCompany Report #2002AP04514 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Hyperosmolar Foreign Seroquel PS ORAL 75 MG DAILY Hospitalization - Coma Health PO Initial or Prolonged Drug Interaction Professional Prednisolone Acetate SS ORAL 20 MG DAILY Other PO Risperidone SS ORAL 2 MG DAILY PO Risperidone SS ORAL 3 MG DAILY PO Chlorpromazine C Levomepromazine C Haloperidol C Brovarin C Isomytal C Artane C Date:04/14/03ISR Number: 4095205-6Report Type:Expedited (15-DaCompany Report #B0295938A Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Literature Paxil (Formulation Initial or Prolonged Health Unknown) (Paroxetine Professional Hydrochloride) PS Risperidone (Formulation Unknown) (Risperidone) SS Date:04/15/03ISR Number: 4095579-6Report Type:Expedited (15-DaCompany Report #NSADSS2003016969 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL 5MG, ORAL Date:04/15/03ISR Number: 4115264-1Report Type:Periodic Company Report #PHEH2002US04083 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Health Tegretol Initial or Prolonged Cogwheel Rigidity Professional (Carbamazepine)Unkno Dizziness wn PS ORAL 400 MG, TID, Drooling ORAL Drug Interaction Risperal Drug Level Decreased (Risperidone) SS ORAL 8 MG, QD, Drug Level Increased ORAL; 6 MG, Lethargy QD, ORAL Malaise Lamictal C Somnolence Haldol "Janssen" C Tremor Melantonin (Melatonin) C Lithium (Lithum) C 22-Feb-2006 08:20 AM Page: 1593 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/03ISR Number: 4115362-2Report Type:Periodic Company Report #2003UW00738 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Seroquel PS ORAL 400 MG BID PO Initial or Prolonged Hypotension Professional Seroquel SS ORAL 500 MG BID PO Psychotic Disorder Atenolol SS 75 MG BID Syncope Risperdal SS 1 MG BID Benazepril SS 10 MG HS Hydrochlorothiazide SS 50 MG DAILY Date:04/16/03ISR Number: 4097136-4Report Type:Expedited (15-DaCompany Report #EMADSS2003003112 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal (1 Mg Health Tablet) Professional (Risperidone) PS ORAL 1 MG DAILY, ORAL Prozac(Fluoxetine Hydrochloride) C Date:04/16/03ISR Number: 4097138-8Report Type:Expedited (15-DaCompany Report #APCDSS2003000517 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperidone(Tablet) Health (Risperidone) PS ORAL 4 MG, DAILY, Professional ORAL Haldol (Unspecified) (Haloperidol) C Date:04/16/03ISR Number: 4097139-XReport Type:Expedited (15-DaCompany Report #NSADSS2003013478 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adenocarcinoma Foreign Risperidone Initial or Prolonged Diabetes Mellitus Literature (Unspecified) Required Endometrial Cancer Health (Risperidone) PS ORAL 2 MG, DAILY, Intervention to Professional ORAL Prevent Permanent Chlorpromazine Impairment/Damage (Chlorpromazine) SS 37.5 MG, DAILY Date:04/16/03ISR Number: 4097151-0Report Type:Expedited (15-DaCompany Report #EMADSS2003003122 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Risperidone (0.5 Mg Cardiovascular Disorder Health Tablet) Dizziness Professional (Risperidone) PS ORAL 0.5 MG, 2 IN Hypotension 1 DAY(S), ORAL 2 DAY Rytmonorm (Propafenone Hydrochloride) C Plavix (Clopidorel Sulfate) C 22-Feb-2006 08:20 AM Page: 1594 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aricept (Donepezil Hydrochloride) C Cornagin (Isosorbide Mononitrate) C Alna (Tamsulosin Hydrochloride) C Date:04/16/03ISR Number: 4097627-6Report Type:Expedited (15-DaCompany Report #B0295938A Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Literature Paxil (Paroxetine Initial or Prolonged Asthenia Health Hydrochloride) PS Cold Sweat Professional Risperidone Dizziness (Risperidone) SS Heart Rate Irregular Lethargy Serotonin Syndrome Date:04/18/03ISR Number: 4098711-3Report Type:Expedited (15-DaCompany Report #EMADSS2003002879 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS Dipiperon (Pipamperone) C Date:04/21/03ISR Number: 4093998-5Report Type:Expedited (15-DaCompany Report #CH-ROCHE-335934 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Condition Aggravated Consumer Valium PS Roche ORAL Hospitalization - Electrocardiogram Qt Ketalgine Initial or Prolonged Prolonged (Switzerland) SS ORAL Hypomagnesaemia Ketalgine Loss Of Consciousness (Switzerland) SS ORAL DOSAGE Syncope DECREASED IN Torsade De Pointes RESPONSE TO EVENTS. Risperdal SS ORAL Ritalin SS UNKNOWN Ritalin SS UNKNOWN Cocaine SS UNKNOWN Ilomedin SS INTRAVENOUS 30 DAY Mst C ORAL Seresta C ORAL Liquemin C INTRAVENOUS STRENGH: 5000 AND 25000 U. 29 DAY Date:04/21/03ISR Number: 4096777-8Report Type:Direct Company Report #CTU 191322 Age:41 YR Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 1595 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Muscle Spasms Seroquel 100mg Myalgia Astrazeneca PS Astrazeneca ORAL 100MG AM 200 Neuroleptic Malignant ORAL Syndrome Risperdal 1mg Janssen SS Janssen ORAL 1MG AM/2MG ORAL Metformin C Trazodone C Acetaminphen C Keflex C Seroquel C Symmetrel C Parlodel C Risperdal C Lithium Carbonate C Wellbutrin C Date:04/21/03ISR Number: 4099204-XReport Type:Expedited (15-DaCompany Report #NSADSS2003017625 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Risperdal Cardiac Arrest Professional (Unspecified) Feeling Abnormal (Risperidone) PS ORAL 0.05 MG, ORAL Dopamine (Dopamine) C Morphine (Morphine) C Date:04/21/03ISR Number: 4099224-5Report Type:Expedited (15-DaCompany Report #EMADSS2003003151 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Abuser Foreign Risperdal (2 Mg Hospitalization - Injection Site Pain Health Tablet) Initial or Prolonged Loss Of Consciousness Professional (Risperidone) PS ORAL 2 MG, DAILY, Medication Error ORAL Peripheral Ischaemia Ketalgin (Methadone Torsade De Pointes Hydrochloride) SS ORAL 160 MG, Ventricular Tachycardia DAILY, ORAL Kokain (Cocaine) SS Ritalin (Methylphenidate Hydrochloride) SS INTRA-ARTERIAL ARTER Valium (Diazepam) SS ORAL 20 MG, DAILY, ORAL Ilomedin (Iloprost) SS INTRAVENOUS 50 MG, DAILY, IV Seresta (Oxazepam) C Mst (Morphine Sulfate) C Liquemin (Heparin) C 22-Feb-2006 08:20 AM Page: 1596 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/03ISR Number: 4099368-8Report Type:Expedited (15-DaCompany Report #APCDSS2003000504 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Risperidone (Tablet) Hospitalization - Blood Creatine Health (Risperidone) PS ORAL 2 MG, DAILY; Initial or Prolonged Phosphokinase Increased Professional ORAL Required Cardio-Respiratory Arrest Etizolam (Etizolam) SS ORAL 0.5 MG, PRN; Intervention to Hypotension ORAL Prevent Permanent Loss Of Consciousness Nitrazepam Impairment/Damage Multi-Organ Failure (Nitrazepam) SS ORAL 1 TABLE; Overdose DAILY; ORAL Prothrombin Time Prolonged Treatment Noncompliance Ventricular Fibrillation Date:04/21/03ISR Number: 4099562-6Report Type:Expedited (15-DaCompany Report #2003-DE-00014GD Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Literature Lithium Carbonate Initial or Prolonged Anxiety (Lithium Carbonate) PS 600 MG > 3 Bipolar Disorder MONTHS Body Temperature Risperidone Increased (Risperidone) SS 3 MG Catatonia Paroxetine Cognitive Disorder (Paroxetine) SS 20 MG Constipation Olanzapine Drug Interaction (Antipsychotics) SS 5 MG Drug Level Below Benztropine Therapeutic (Benzatropine Drug Level Increased Mesilate) SS 2 MG Dry Mouth Nortriptyline Insomnia (Nortriptyline) SS 50 MG Parkinsonism Tremor Vision Blurred Date:04/21/03ISR Number: 4099917-XReport Type:Expedited (15-DaCompany Report #EMADSS2003002618 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Sedation Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 Other DAY(S), ORAL Date:04/22/03ISR Number: 4099903-XReport Type:Direct Company Report #CTU 191465 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Rigidity Risperdal Conc. PS DECREASED TO Tremor 2.5 BID 22-Feb-2006 08:20 AM Page: 1597 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/03ISR Number: 4099957-0Report Type:Expedited (15-DaCompany Report #APCDSS2003000541 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Haldol (Tablet) Extrapyramidal Disorder Health (Haloperidol) PS ORAL SEE IMAGE Weight Increased Professional Risperidone (Tablet) (Risperidone) SS ORAL SEE IMAGE Cardiovascular Agents C Brotizolam (Brotizolam) C Triazolam (Triazolam) C Flunitrazepam (Flunitrazepam) C Date:04/22/03ISR Number: 4099963-6Report Type:Expedited (15-DaCompany Report #EMADSS2003003108 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Atrophy Foreign Risperdal (2 Mg Initial or Prolonged Chest X-Ray Abnormal Health Tablet) Clonic Convulsion Professional (Risperidone) PS ORAL 4 MG, DAILY, Cough ORAL Depressed Level Of Tavanic Consciousness (Levofloxacin) SS ORAL 500 MG, Heart Rate Increased DAILY, ORAL Hyperpyrexia Lysanxia (Prazepam) C Hypotonia Mixtard (Initard) C Lung Disorder Noctran (Noctran) C Oxygen Saturation Dipiperon Decreased (Unspecified) Pulmonary Congestion (Pipamperone) C Somnolence Triatec (Ramipril) C Tachypnoea Mono-Tildiem (Diltiazem Hydrochloride) C Alpress (Prazosin Hydrochloride) C Date:04/22/03ISR Number: 4099964-8Report Type:Expedited (15-DaCompany Report #APCDSS2003000397 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autoimmune Disorder Foreign Risperidone (Tablet) Initial or Prolonged Haemorrhage Health (Risperidone) PS ORAL 3 MG, Oedema Peripheral Professional DAILY,ORAL Thrombocytopenia Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS ORAL 62.5 MG, DAILY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Pantethine (Pantethine) C 22-Feb-2006 08:20 AM Page: 1598 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/03ISR Number: 4100133-3Report Type:Expedited (15-DaCompany Report #APCDSS2003000394 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Cirrhosis Foreign Risperidone Leukopenia Health (Unspecified) Thrombocytopenia Professional (Risperidone) PS ORAL 6 MG, DAILY, ORAL Etizolam (Etizolam) SS ORAL 3 MG, DAILY, ORAL Date:04/22/03ISR Number: 4100203-XReport Type:Expedited (15-DaCompany Report #2003CG00601 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Mopral PS ORAL 1 DF DAILY PO Initial or Prolonged Nausea Health Imovane SS ORAL 7.5 MG DAILY Weight Decreased Professional PO Other Levothyrox SS ORAL 50 UG DAILY PO Risperdal SS ORAL 0.75 MG DAILY PO Equanil SS ORAL 200 MG BID PO Aricept SS ORAL 10 MG DAILY PO Date:04/22/03ISR Number: 4100840-2Report Type:Expedited (15-DaCompany Report #NSADSS2003017814 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal Professional (Unspecified) Company (Risperidone) PS ORAL ORAL Representative Date:04/23/03ISR Number: 4101575-2Report Type:Expedited (15-DaCompany Report #B0295904A Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Literature Paxil (Formulation Hospitalization - Atrophy Health Unknown) (Paroxetine Initial or Prolonged Coma Professional Hydrochloride) PS 10 MG PER DAY Condition Aggravated Risperidone Death (Formulation Dementia Unknown) Psychotic Disorder (Risperidone) SS Serotonin Syndrome Quinapril C Simvastatin C Date:04/23/03ISR Number: 4101747-7Report Type:Expedited (15-DaCompany Report #NSADSS2003017817 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1599 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/03ISR Number: 4101748-9Report Type:Expedited (15-DaCompany Report #NSADSS2003018112 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 1 IN 72 HOUR (S), ORAL Date:04/23/03ISR Number: 4101756-8Report Type:Expedited (15-DaCompany Report #NSADSS2003001055 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Study Risperidone Initial or Prolonged Blood Urea Health (Risperidone) PS Diabetic Gastroparesis Professional Ziprasidone SS Gastroenteritis Viral Depakote (Valproate Ileus Paralytic Semisodium) C Pancreatitis Klonopin Sinus Tachycardia (Clonazepam) C Small Intestinal Lipitor Obstruction (Atorvastatin) C White Blood Cell Count Vasotec (Enalapril Maleate) C Neurontin (Gabapentin) C Zoloft (Sertraline Hydrochloride) C Trazodone (Trazodone) C Iron (Iron) C Multivitamins (Multivitamins) C Insulin 70/30 (Human Mixtard) C Colace (Docusate Sodium) C Protonix (Pantoprazole) C Date:04/23/03ISR Number: 4101895-1Report Type:Expedited (15-DaCompany Report #APCDSS2002001569 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Foreign Risperidone(Tablet) Hospitalization - Blood Pressure Systolic Health (Risperidone) PS ORAL 3 MG, DAILY, Initial or Prolonged Increased Professional ORAL : 2 MG, Depressed Level Of DAILY, ORAL : Consciousness 1 MG, DAILY, Mitral Valve Incompetence ORAL Respiratory Depression Trihexyphenidyl Respiratory Failure Hydrochloride Somnolence (Trihexyphenidyl Hydrochloride) C Trapidil (Trapidil) C Ubidecarenone (Ubidecarenone) C Sennoside (Sennosides) C Potassium Chloride (Potassium Chloride) C 22-Feb-2006 08:20 AM Page: 1600 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/03ISR Number: 4101897-5Report Type:Expedited (15-DaCompany Report #APCDSS2003000151 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ileus Paralytic Foreign Risperidone (Tablet) Initial or Prolonged Health (Risperidone) PS ORAL 6 MG, DAILY, Professional ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Candesartan Cilexetil(Candesarta n Cilexetil) C Senna Extract (Senna) C Date:04/23/03ISR Number: 4101899-9Report Type:Expedited (15-DaCompany Report #EMADSS2003003285 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis A Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG DAILY, ORAL Reminyl (Unspecified) (Galantamine) SS ORAL 4 MG, DAILY, ORAL Melperone (Melperone) C Pantoprazole (Pantoprazole) C Ass (Acetylsalicylic Acid) C Spironolactone (Spironolactone) C Date:04/23/03ISR Number: 4112456-2Report Type:Periodic Company Report #A0380041A Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Eskalith Initial or Prolonged Aspartate Professional Tablet-Controlled Disability Aminotransferase Release (Lithium Required Csf White Blood Cell Carbonate) PS ORAL 450 MG / Intervention to Count Increased TWICE PER DAY Prevent Permanent Neuroleptic Malignant / ORAL Impairment/Damage Syndrome Risperidone (Risperidone) SS ORAL 3 MG / AT NIGHT / ORAL Date:04/24/03ISR Number: 4102162-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB01680 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Hospitalization - Convulsion Foreign Initial or Prolonged Drug Interaction Health Psychotic Disorder Professional 22-Feb-2006 08:20 AM Page: 1601 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Carbamazepine(Carbam azepine) Unknown PS 200 MG, QD, UNKNOWN Risperdal(Risperidon e) SS INTRAMUSCULAR 25 MG, QD, INTRAMUSCULAR Paroxetine C Lorazepam C Risperidone C Haloperidol C Date:04/24/03ISR Number: 4102178-6Report Type:Expedited (15-DaCompany Report #EMADSS2003003240 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Risperdal (1 Mg Initial or Prolonged Extrapyramidal Disorder Health Tablet) Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Ditropan (Oxybutynin) C Date:04/24/03ISR Number: 4102179-8Report Type:Expedited (15-DaCompany Report #EMADSS2003003285 Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis A Antibody Foreign Risperdal Positive Health (Unspecified) Professional (Risperidone) PS ORAL 0.5 MG, DAILY, ORAL Reminyl (Unspecified) (Galantamine) SS ORAL 4 MG, DAILY, ORAL Melperone (Melperone) C Pantoprazole (Pantoprazole) C Ass (Acetylsalicylic Acid) C Spironolactone (Spironolactone) C Date:04/24/03ISR Number: 4102860-0Report Type:Expedited (15-DaCompany Report #NSADSS2003018025 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Risperdal Hospitalization - Coordination Abnormal Literature (Unspecified) Initial or Prolonged Disorientation Health (Risperidone) PS 3 MG, 2 IN 1 Lethargy Professional DAY(S), Miosis Ritonavir Somnolence (Ritonavir) SS 200 MG, 2 IN 1 DAY(S), Zidovudine 22-Feb-2006 08:20 AM Page: 1602 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Zidovudine) C Didanosine (Didanosine) C Indinavir (Indinavir) C Date:04/25/03ISR Number: 4101036-0Report Type:Expedited (15-DaCompany Report #NSADSS2003018013 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Megacolon Foreign Risperidal Initial or Prolonged Literature (Risperidone) PS 3.5 MG, DAILY Required Health Haldol (Haloperidol) C Intervention to Professional Trifluoperazine Prevent Permanent (Trifluoperazine) C Impairment/Damage Trihexyphenidyl (Trihexyphenidyl) C Date:04/25/03ISR Number: 4101039-6Report Type:Expedited (15-DaCompany Report #APCDSS2003000556 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Acute Foreign Risperidone (Tablet) Suicide Attempt Health (Risperidone) PS 1-2 MG DAILY Professional Haldol (Injection) (Haloperidol) SS INTRAVENOUS 5 MG, DAILY, IV Mianserin Hydrochloride (Mianserin Hydrochloride) SS ORAL 10 MG, DAILY, ORAL Brotizolam (Brotizolam) C Bromvalerylurea (Bromisoval) C Lormetazepam (Lormetazepam) C Zolpidem Tartrate (Zolpidem Tartrate) C Date:04/25/03ISR Number: 4101041-4Report Type:Expedited (15-DaCompany Report #APCDSS2003000557 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Risperidone Hospitalization - Consciousness Health (Risperidone) PS ORAL ORAL Initial or Prolonged Oliguria Professional Rhabdomyolysis Date:04/25/03ISR Number: 4101048-7Report Type:Direct Company Report #USP 55824 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Risperdal PS Janssen Pharmaceuticals TABLET Risperdal SS Janssen Pharma 22-Feb-2006 08:20 AM Page: 1603 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/03ISR Number: 4102930-7Report Type:Expedited (15-DaCompany Report #APCDSS2003000504 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Risperidone (Tablet) Hospitalization - Arrhythmia Health (Risperidone) PS ORAL 2 MG, DAILY, Initial or Prolonged Cardio-Respiratory Arrest Professional ORAL Required Electrocardiogram Qt Etizolam (Etizolam) SS ORAL 0.5 MG, PRN, Intervention to Prolonged ORAL Prevent Permanent Electrolyte Imbalance Nitrazepam(Nitrazepa Impairment/Damage Hypotension m) SS ORAL 1 TABLE, Insomnia DAILY, ORAL Loss Of Consciousness Medication Error Multi-Organ Failure Overdose Treatment Noncompliance Date:04/25/03ISR Number: 4102933-2Report Type:Expedited (15-DaCompany Report #APCDSS2003000556 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Acute Foreign Haldol (Injection) Suicide Attempt Health (Haloperidol) PS INTRAVENOUS 5 MG, DAILY, Professional IV Risperidone (Tablet) (Risperidone) SS 1-2 MG DAILY Mianserin Hydrochoride (Mianserin Hydrochloride) SS ORAL 10 MG, DAILY, ORAL Brotizolam (Brotizolam) C Bromvalerylurea (Bromisoval) C Lormetazepam (Lormetazepam) C Zolpidem Tartrate (Zolpidem Tartrate) C Date:04/25/03ISR Number: 4103103-4Report Type:Expedited (15-DaCompany Report #2003003590 Age: Gender:Male I/FU:I Outcome PT Other Asthma Decreased Activity Diarrhoea Difficulty In Walking Drug Effect Decreased Gout Hypoaesthesia Influenza Like Illness Joint Stiffness Movement Disorder Muscle Rigidity Neuroleptic Malignant Syndrome Oedema Peripheral Paraesthesia 22-Feb-2006 08:20 AM Page: 1604 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Restless Legs Syndrome Sensory Loss Report Source Product Role Manufacturer Route Dose Duration Health Geodon (Ziprasidone) PS ORAL 20 MG (QD), Professional ORAL Company Risperidone Representative (Risperidone) SS Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) C Lamotrigine (Lamotrigine) C Sinemet (Levodopa, Carbidopa) C Prqpranolol (Propranolol) C Theophylline (Theophylline) C Formoterol Fumarate (Formoterol Fumarate) C Loratadine (Loratadine) C Salbutamol (Salbutamol) C Alprazolam (Alprazolam) C Colchicine (Colchicine) C Date:04/25/03ISR Number: 4103184-8Report Type:Expedited (15-DaCompany Report #NSADSS2003018874 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Neoplasm Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 1 MG, 4 IN 24 HOUR (S), ORAL Date:04/25/03ISR Number: 4103226-XReport Type:Expedited (15-DaCompany Report #NSADSS2003018595 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:04/25/03ISR Number: 4103229-5Report Type:Expedited (15-DaCompany Report #NSADSS2003018388 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS 22-Feb-2006 08:20 AM Page: 1605 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/03ISR Number: 4103232-5Report Type:Expedited (15-DaCompany Report #NSADSS2003003109 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Health Risperdal Disease Progression Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:04/28/03ISR Number: 4101617-4Report Type:Direct Company Report #CTU 191730 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Accident Risperdal 0.5mg Hospitalization - Dementia Janssen PS Janssen ORAL 0.5MG BEDTIME Initial or Prolonged Drug Ineffective ORAL Disability Date:04/28/03ISR Number: 4104078-4Report Type:Expedited (15-DaCompany Report #NSADSS2003002403 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (Tablet0 Professional (Risperidone) PS ORAL 4 MG, 1 IN 1 DAY(S), ORAL Date:04/28/03ISR Number: 4104079-6Report Type:Expedited (15-DaCompany Report #NSADSS2003019453 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Consumer Haldol (Injection) Initial or Prolonged Dystonia Health (Haloperidol) PS INTRAMUSCULAR 2.5 , IM Professional Risperdal (Unspecified) (Risperidone) SS ORAL 1 IN 1 TIME(S) , ORAL 1 WK Date:04/28/03ISR Number: 4104508-8Report Type:Expedited (15-DaCompany Report #EMADSS2003000499 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haemorrhage Foreign Risperdal (1 Mg Initial or Prolonged Vasculitis Necrotising Health Tablet) Professional (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Glicazida (Gliclazide) C Diltiazem (Diltiazem) C Acarbose (Acarbose) C Ramipril (Ramipril) C 22-Feb-2006 08:20 AM Page: 1606 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/03ISR Number: 4104509-XReport Type:Expedited (15-DaCompany Report #APCDSS2003000555 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Foreign Risperidone (Tablet) Initial or Prolonged Arrhythmia Consumer (Risperidone) PS ORAL SEE IMAGE Blood Pressure Decreased Heart Rate Decreased Nausea Pain Pulmonary Congestion Tachycardia Date:04/28/03ISR Number: 4104510-6Report Type:Expedited (15-DaCompany Report #EMADSS2003003388 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Risperdal (4 Mg Decreased Health Tablet) Professional (Risperidone) PS ORAL 4 MG, DAILY, Company ORAL Representative Lysanxia (Prazepam) C Prozac (Fluoxetine Hydrochloride) C Depamide (Valpromide) C Date:04/28/03ISR Number: 4104511-8Report Type:Expedited (15-DaCompany Report #EMADSS2003003373 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Delusional Disorder, Foreign Risperdal Hospitalization - Unspecified Type Health (Unspecified) Initial or Prolonged Pneumonia Professional (Risperidone) PS ORAL 2 MG, DAILY, Shock Company ORAL Representative Topamax (Unspecified) (Topiramate) C Keppra (Levetiracetam) C Lasix (Furosemide) C Unat (Torsemide) C Date:04/28/03ISR Number: 4104512-XReport Type:Expedited (15-DaCompany Report #EMADSS2003003374 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Respiratory Distress Foreign Risperdal (2 Mg Health Tablet) Professional (Risperidone) PS ORAL 4 MG, DAILY, ORAL Imovane (Zopiclone) SS ORAL 7.5 MG, DAILY, ORAL Seresta (Oxazepam) SS ORAL 50 MG, DAILY, ORAL Noctran (Noctran) SS ORAL 10 MG, DAILY, ORAL Gardenal (Phenobarbital) SS ORAL 50 MG, DAILY, 22-Feb-2006 08:20 AM Page: 1607 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Driptane (Oxybutynin Hydrochloride) SS ORAL 15 MG, DAILY, ORAL Forlax (Macrogol) C Co-Aprovel (Irbesartan) C Hyperium (Rilmenidine) C Zyrtec (Cetrizine Hydrochloride) C Tardyferon (Ferrous Sulfate) C Ginkor (Ginkor) C Voltarene (Diclofenac Sodium) C Biafine (Biafine) C Dialgirex (Di-Gesic) C Art 50 (Diacerein) C Normacol (Normacol) C Levodphta (Levocabastine Hydrochloride) C Date:04/28/03ISR Number: 4104538-6Report Type:Expedited (15-DaCompany Report #EMADSS2003000923 Age:92 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypokalaemia Foreign Risperdal (Solution) Initial or Prolonged Myelodysplastic Syndrome Health (Risperidone) PS ORAL SEE IMAGE Required Oedema Professional Josir Lp (Tamsulosin Intervention to Pain Hydrochloride) C Prevent Permanent Pancytopenia Dexorat (Paroxetine Impairment/Damage Tachycardia Hydrochloride) C Tranxene (Clorazepate Dipotassium) C Date:04/29/03ISR Number: 4103790-0Report Type:Direct Company Report #CTU 191941 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Priapism Risperidone PS ORAL 2 MG PRN 3 Q HS (PO) Date:04/30/03ISR Number: 4103745-6Report Type:Direct Company Report #CTU 191992 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Orthostatic Hypotension Risperidone 3mg Initial or Prolonged Tablet PS ORAL 6 MG PO BID Hctz C Lisinopril C 22-Feb-2006 08:20 AM Page: 1608 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/03ISR Number: 4104534-9Report Type:Expedited (15-DaCompany Report #NSADSS2003019369 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:04/30/03ISR Number: 4104536-2Report Type:Expedited (15-DaCompany Report #NSADSS2003019046 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN DAILY, ORAL Date:04/30/03ISR Number: 4104537-4Report Type:Expedited (15-DaCompany Report #NSADSS2003008539 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS Date:04/30/03ISR Number: 4104651-3Report Type:Expedited (15-DaCompany Report #NSADSS2003019099 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Reminyl Professional (Unspecified) Company (Galantamine) PS ORAL ORAL Representative Risperdal (Unspecified) (Risperidone) SS ORAL ORAL Date:04/30/03ISR Number: 4105379-6Report Type:Expedited (15-DaCompany Report #APCDSS2003000581 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acidosis Foreign Risperidone (Tablet) Overdose Health (Risperidone) PS ORAL 100 TABLE, 1 Rhabdomyolysis Professional IN 1 TIME, Suicide Attempt ORAL Caffeine Anhydrous (Caffeine) C Date:04/30/03ISR Number: 4105817-9Report Type:Expedited (15-DaCompany Report #B0295904A Age:86 YR Gender:Male I/FU:F Outcome PT Death Aggression Hospitalization - Agitation Initial or Prolonged Asthenia Death Dementia Depressed Level Of 22-Feb-2006 08:20 AM Page: 1609 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Consciousness Psychotic Disorder Serotonin Syndrome Report Source Product Role Manufacturer Route Dose Duration Literature Paxil (Formulation Health Unknown) (Paroxetine Professional Hydrochloride) PS 10 MG/PER DAY Risperidone (Formulation Unknown) (Risperidone) SS Quinapril C Simvastatin C Date:04/30/03ISR Number: 4105888-XReport Type:Expedited (15-DaCompany Report #NSADSS2003019721 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Health Risperdal Sedation Professional (Unspecified) (Risperidone) PS ORAL ORAL Calcium C Date:04/30/03ISR Number: 4105892-1Report Type:Expedited (15-DaCompany Report #NSADSS2003003880 Age:87 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Activated Partial Health Risperdal Thromboplastin Time Professional (Unspecified) Asthenia (Risperidone) PS ORAL 1 MG, 1 IN Blood Creatinine DAILY, ORAL Blood Urea Clonidine C Blood Uric Acid Increased Coumadin (Warfarin Cellulitis Sodium) C Difficulty In Walking Verapamil C Haematocrit Colchicine C Haemoglobin Prandin International Normalised (Repaglinide) C Ratio Increased Lasix (Furosemide) C Osteomyelitis Asa (Acetylsalicylic Prothrombin Time Acid) C Prolonged Anemagen C Purulence Vitamin B12 Deficiency White Blood Cell Count Date:05/01/03ISR Number: 4101750-7Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0293076A Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Health Paxil PS Glaxosmithkline ORAL 30MG per day Initial or Prolonged Jaw Disorder Professional Fluvoxamine Maleate SS ORAL 200MG per day Other Muscle Rigidity Risperidone SS ORAL 2MG per day Speech Disorder Phenothiazine SS ORAL Over Counter Cold Remedy SS ORAL 1 DAY 22-Feb-2006 08:20 AM Page: 1610 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/01/03ISR Number: 4106334-2Report Type:Expedited (15-DaCompany Report #NSADSS2003020164 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) Company (Risperidone) PS ORAL ORAL Representative Date:05/01/03ISR Number: 4106358-5Report Type:Expedited (15-DaCompany Report #APCDSS2003000555 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Risperidone (Tablet) Initial or Prolonged Blood Pressure Diastolic Consumer (Risperidone) PS ORAL SEE IMAGE Decreased Heart Rate Decreased Nausea Pain Of Skin Respiratory Tract Congestion Tachycardia Date:05/01/03ISR Number: 4106359-7Report Type:Expedited (15-DaCompany Report #APCDSS2003000557 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dialysis Foreign Risperidone (Tablet) Hospitalization - Hyperkalaemia Health (Risperidone) PS ORAL 3 MG, DAILY, Initial or Prolonged Loss Of Consciousness Professional ORAL Required Rhabdomyolysis Tiapride Intervention to Stupor Hydrochloride Prevent Permanent (Tiapride Impairment/Damage Hydrochloride) SS ORAL 100 MG, DAILY, ORAL Chlorpromazine Hydrochloride SS ORAL 25 MG, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Magnesium Oxide (Magnesium Oxide) C Lactulose (Lactulose) C Aminoleban (Aminoleban) C Cimetidine (Cimetidine) C Date:05/01/03ISR Number: 4106360-3Report Type:Expedited (15-DaCompany Report #EMADSS2003003240 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Risperdal Initial or Prolonged Extrapyramidal Disorder Health (Risperidone) PS ORAL 1 MG, DAILY, Professional ORAL Ditropan (Oxybutynin 22-Feb-2006 08:20 AM Page: 1611 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) SS ORAL 5 MG, 3 IN 1 DAY (S), ORAL 10 YR Date:05/01/03ISR Number: 4106361-5Report Type:Expedited (15-DaCompany Report #EMADSS2003003405 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Risperdal Neuroleptic Malignant Health (Risperidone) PS ORAL 1.5 MG, Syndrome Professional DAILY, ORAL Other Doxycyclinum (Doxycycline) SS UNKNOWN 100 MG, 1 IN 1 DAY (S) UNKNOWN 1 WK Seresta (Oxazepam) C Date:05/01/03ISR Number: 4106363-9Report Type:Expedited (15-DaCompany Report #EMADSS2003002879 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal (Tablet) Leukopenia Health (Risperidone) PS ORAL 1 MG, 2 IN 1 Professional DAY (S), ORAL Dipiperon (Unspecified) (Pipamperone) C Date:05/01/03ISR Number: 4106483-9Report Type:Expedited (15-DaCompany Report #03P-028-0217147-00 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Valproic Acid Intervention to Neutropenia Literature (Depakene) (Valproic Prevent Permanent White Blood Cell Count Health Acid) (Valproic Impairment/Damage Decreased Professional Acid) PS 1500 MG, 1 IN 1 D Divalproex Sodium (Depakote) (Divalproex Sodium) (Divalproex Sodium) SS 1500 MG, 1 IN 1 D APPROXIMATELY 1999 Haloperidol SS SEE IMAGE Clozapine SS SEE IMAGE Risperidone SS 2 MG, 1 IN 1 D, Levomepromazine C Procyclidine C Date:05/02/03ISR Number: 4106597-3Report Type:Expedited (15-DaCompany Report #NSADSS2003019221 Age:83 YR Gender:Female I/FU:I Outcome PT Hospitalization - Cerebral Atrophy Initial or Prolonged Hypotonia Lobar Pneumonia Pneumonia Aspiration 22-Feb-2006 08:20 AM Page: 1612 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Somnolence Report Source Product Role Manufacturer Route Dose Duration Foreign Levofloxacin Health (Tablet) Professional (Levofloxacin) PS ORAL 500 MG, ORAL Risperdal (2 Mg Tablet) (Risperidone) SS ORAL 2 MG, ORAL Lysanxia (Prazepam) C Mixtard (Initard) C Noctran (Noctran) C Dipiperon (Pipamperone) C Triatec (Ramipril) C Monotildiem (Diltiazem Hydrochloride) C Alpress (Prazosin Hydrochloride) C Date:05/02/03ISR Number: 4106634-6Report Type:Expedited (15-DaCompany Report #EMADSS2003003488 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal (Tablet) Initial or Prolonged Hyperprolactinaemia Health (Risperidone) PS ORAL SEE IMAGE Professional Sertraline Hydrochloride (Sertraline Hydrochloride) SS ORAL SEE IMAGE Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:05/02/03ISR Number: 4107010-2Report Type:Expedited (15-DaCompany Report #PHBS2003CH03918 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Foreign Ritalin Initial or Prolonged Blood Magnesium Decreased Health (Methylphenidate Disability Drug Abuser Professional Hydrochloride) Electrocardiogram Qt Other Tablet PS 10 MG/DAY, Prolonged INJECTION NOS Extremity Necrosis Ketalgin(Methadone Finger Amputation Hydrochloride) SS 160 MG/DAY Gangrene Risperdal(Risperidon Intentional Misuse e) SS 2 MG/DAY Loss Of Consciousness Valium(Diazepam) SS 20 MG/DAY Medication Error Urokinase(Urokinase) SS INTRAVENOUS 5000 IU, Necrosis Ischaemic INTRAVENOUS Peripheral Ischaemia Ilomedin(Iloprost) SS INTRAVENOUS 50 MG, Syncope INTRAVENOUS Torsade De Pointes Mst (Morphine Ventricular Tachycardia Sulfate) C Seresta (Oxazepam) C Liquemin (Heparin) C 22-Feb-2006 08:20 AM Page: 1613 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/03ISR Number: 4107250-2Report Type:Expedited (15-DaCompany Report #FRWYE102622APR03 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Seresta (Oxazepam, Life-Threatening Respiratory Distress Professional Tablet, 0) PS ORAL 50 MG 1X PER Other 1 DAY ORAL 1344 DAY Driptane (Oxybutynin Hydrochloride, ,0) SS ORAL 5 MG 3X PER 1 DAY ORAL 1435 DAY Gardenal (Phenobarbital, ,0) SS ORAL 50 MG 1X PER 1 DAY ORAL 1191 DAY Imovane (Zopiclone, ,0) SS ORAL 7.5 MG 1X PER 1 DAY ORAL 1435 DAY Noctran 10 (Acepromazine/Acepro metazine/Clorazepate Dipotassium, ,0) SS ORAL 10 MG 1X PER 1 DAY ORAL 674 DAY Risperdal (Risperidone, ,0) SS ORAL 4 MG 1X PER 1 DAY ORAL 1191 DAY Coaprovel (Irbesartan/Hydrochl orothiazide) C Hyperium (Rilmenidine) C Zyrtec (Cetirizine Hydrochloride) C Tardyferon (Ferrous Sulfate) C Ginkor (Ginkgo Tree Leaves Extract/Troxerutin) C Voltaren Emulgel (Diclofenac Diethylamine) C Biafine (Cetyl Palmitate/Ethylene Glycol Monostearate/Paraffi n/Paraffin, C Art 50 (Diacerein) C Forlax (Macrogol) C Normacol (Frangula Extract/Sterculia) C Levophta (Levocabastine Hydrochloride) C Dextropropoxyphene (Dextropropoxyphene) C Paracetamol (Paracetamol) C 22-Feb-2006 08:20 AM Page: 1614 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/03ISR Number: 4107464-1Report Type:Expedited (15-DaCompany Report #NSADSS2003020111 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Study Risperdal (Tablet) Complications Of Maternal Health (Risperidone) PS ORAL 2 MG, DAILY, Exposure To Therapeutic Professional ORAL Drugs Olanzapine Maternal Drugs Affecting (Olanzapine) C Foetus Mellaril Pregnancy (Thioridazine Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Prevacid (Lansoprazole) C Trazodone (Trazodone) C Date:05/05/03ISR Number: 4107976-0Report Type:Expedited (15-DaCompany Report #APCDSS2003000556 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Risperidone (Tablet) Hospitalization - Complete Health (Risperidone) PS 1-2 MG DAILY Initial or Prolonged Blood Potassium Decreased Professional THEN 2 MG Required Blood Pressure Decreased DAILY Intervention to Cardio-Respiratory Arrest Haldol (Injection) Prevent Permanent Delirium (Haloperidol) SS INTRAVENOUS 5 MG, DAILY, Impairment/Damage Dialysis IV Gamma-Glutamyltransferase Mianserin Increased Hydrochloride Insomnia (Mianserin Kidney Enlargement Hydrochloride) SS ORAL 10 MG, DAILY, Myopathy ORAL Renal Failure Acute Brotizolam Therapeutic Response (Brotizolam) C Decreased Bromvalerylurea (Bromisoval) C Lormetazepam (Lormetazepam) C Zolpidem Tartrate (Zolpidem Tartrate) C Hydrocortisone (Hydrocortisone) C Levothyroxine Sodium (Levothyroxine Sodium) C Desmopressin Acetate (Desmopressin Acetate) C Theophylline (Theophylline) C Rinderon 0 Vg (Valisone-G) C Clobetasone Butyrate (Clobetasone Butyrate) C Trazodone Hydrochloride (Trazodone 22-Feb-2006 08:20 AM Page: 1615 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Dydrogesterone (Dydrogesterone) C Pravastatin Sodium (Pravastatin Sodium) C Hydrocortisone Sodium Succinate (Hydrocortisone Sodium) C Date:05/05/03ISR Number: 4107977-2Report Type:Expedited (15-DaCompany Report #APCDSS2003000397 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autoimmune Disorder Foreign Risperidone (Tablet) Initial or Prolonged Haemorrhage Health (Risperidone) PS ORAL 3 MG, DAILY, Oedema Peripheral Professional ORAL Thrombocytopenia Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS ORAL 62.5 MG, DAILY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Pantethine (Pantethine) C Date:05/05/03ISR Number: 4107979-6Report Type:Expedited (15-DaCompany Report #EMADSS2002006748 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Renal Failure Chronic Health (Unspecified) Professional (Risperidone) PS ORAL 1.5 MG, DAILY, ORAL Loperamide (Unspecified) (Loperamide) C Fluoxetine (Fluoxetine) C Atenolol (Atenolol) C Enalapril (Enalapril) C Salicylic Acid (Salicylic Acid) C Piroxicam (Prioxicam) C Date:05/05/03ISR Number: 4107980-2Report Type:Expedited (15-DaCompany Report #NSADSS2003020845 Age:33 YR Gender:Female I/FU:I Outcome PT Death Anaemia Hospitalization - Asthenia Initial or Prolonged Cardio-Respiratory Arrest Chest Pain Condition Aggravated 22-Feb-2006 08:20 AM Page: 1616 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diabetes Mellitus Hyperhidrosis Hypokalaemia Report Source Product Role Manufacturer Route Dose Duration Muscle Rigidity Foreign Risperdal Quadriplegia Literature (Unspecified) Sepsis Health (Risperidone) PS ORAL 6 MG, DAILY, Urinary Retention Professional ORAL Zotepine (Zotepine) C Chlorpromazine And Preparations (Chlorpromazine) C Nifedipine (Nifedipine) C Nifedipine (Nifedipine) C Glibenclamide (Glibenclamide) C Voglibose (Voglibose) C Simvastatin (Simvastatin) C Bezafibrateb (Bezafibrate) C Date:05/05/03ISR Number: 4108178-4Report Type:Expedited (15-DaCompany Report #APCDSS2003000541 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Haldol (Tablet) Extrapyramidal Disorder Health (Haloperidol) PS 0.5 MG, General Physical Health Professional DAILY; 3 MG, Deterioration DAILY, ORAL Weight Increased Risperidone (Tablet) (Risperidone) SS 2 MG, DAILY; 6 MG, DAILY, ORAL Cardiovascular Agents C Brotizolam (Brotizolam) C Triazolam (Triazolam) C Flunitrazepam (Flunitrazepam) C Date:05/05/03ISR Number: 4108181-4Report Type:Expedited (15-DaCompany Report #APCDSS2003000556 Age:30 YR Gender:Female I/FU:F Outcome PT Death Atrioventricular Block Hospitalization - Complete Initial or Prolonged Blood Creatine Phosphokinase Increased Blood Potassium Abnormal Blood Pressure Decreased Cardio-Respiratory Arrest Delirium Drug Effect Decreased Drug Ineffective 22-Feb-2006 08:20 AM Page: 1617 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Insomnia Kidney Enlargement Renal Failure Acute Report Source Product Role Manufacturer Route Dose Duration Suicide Attempt Foreign Haldol (Injection) Health (Haloperidol0 PS INTRAVENOUS 5 MG, DAILY, Professional IV Risperidone (Tablet) (Risperidone) SS 1-2 MG DAILY THEN 2 MG DAILY Miaserin Hydrochloride (Mianserin Hydrochloride) SS ORAL 10 MG, DAILY, ORAL Brotizolam (Brotizolam) C Bromvalerylurea (Bromisoval) C Lormetazepam (Lormetazepam) C Zolpidem Tartrate (Zolpidem Tartrate) C Hydrocortisone (Hydrocortisone) C Levothyroxine Sodium (Levothyroxine Sodium) C Desmopressin Acetate (Desmopressin Acetate) C Theophylline (Theophylline) C Ridneron-Vg (Valisone-G) C Clobetasone Butyrate (Clobetasone Butyrate) C Trazodone Hydrochloride (Trazodone Hydrochloride) C Dydrogesterone (Dydrogesterone) C Pravastatin Sodium (Pravastatin Sodium) C Hydrocortisone Sodium Succinate (Hydrocortisone Sodium Succinate) C Date:05/06/03ISR Number: 4108459-4Report Type:Expedited (15-DaCompany Report #EMADSS2003003657 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal(Unspecifie d) (Risperidone) PS 22-Feb-2006 08:20 AM Page: 1618 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/03ISR Number: 4108461-2Report Type:Expedited (15-DaCompany Report #APCDSS2003000614 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compartment Syndrome Foreign Risperdal Initial or Prolonged Overdose Health (Unspecified) Rhabdomyolysis Professional (Risperidone) PS 120 MG OVER Vasculitic Rash 17 HOUR PERIOD. Date:05/06/03ISR Number: 4108462-4Report Type:Expedited (15-DaCompany Report #EMADSS2003003374 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Foreign Body Aspiration Foreign Risperdal (2 Mg Respiratory Distress Health Tablet) Professional (Risperidone) PS ORAL 4 MG, DAILY, ORAL Imovane (Zopiclone) SS ORAL 7.5 MG, DAILY, ORAL Seresta (Oxazepam) SS ORAL 50 MG, DAILY, ORAL Noctran (Noctran) SS ORAL 10 MG, DAILY, ORAL Gardenal (Phenobarbital) SS ORAL 50 MG, DAILY, ORAL Driptane (Oxybutynin Hydrochloride) SS ORAL 15 MG, DAILY, ORAL Forlax (Macrogol) C Co-Aprovel (Irbesartan) C Hyperium( Rilmenidine) C Zyrtec (Cetirizine Hydrochloride) C Tardyferon (Ferrous Sulfate) C Ginkor (Ginkor) C Voltarene (Diclofenac Sodium) C Biafine (Biafine) C Dialgirex (Di-Gesic) C Art 50 (Diacerein) C Normacol (Normacol) C Levophta (Levocabastine Hydrochloride) C Date:05/06/03ISR Number: 4108483-1Report Type:Expedited (15-DaCompany Report #2003101286 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Foreign Diphenhydramine Initial or Prolonged Fall Health (Diphenhydramine) PS ORAL 80 TABS ONCE Intentional Overdose Professional (TOTAL DOSE Renal Failure OF 4 GM), Rhabdomyolysis ORAL Suicide Attempt Risperidone 22-Feb-2006 08:20 AM Page: 1619 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) SS ORAL 25 MG DAILY, ORAL Date:05/06/03ISR Number: 4108571-XReport Type:Expedited (15-DaCompany Report #6003390 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Other Levothyrox 50 Initial or Prolonged Nausea (Tablets) Weight Decreased (Levothyroxine Sodium) PS ORAL (1 IN 1 D) ORAL Imovane (7.5 Mg, Tablets) (Zopiclone) SS ORAL 1,00 DOSAGE FORMS (1 DOSAGE FORMS, 1 IN 1 D) ORAL Risperdal (Risperidone) SS ORAL 0.75 MG (1 IN 1 D) ORAL Mopral (Omeprazole) SS ORAL (1 IN 1 D) ORAL Equanil (Tablets) (Meprobamate) SS ORAL 400 MG (0,5 DOSAGE FORMS, 2 IN 1 D) ORAL Aricept (Donepezil Hydrochloride) SS 10 MG (1 IN 1 D) 110 DAY Date:05/06/03ISR Number: 4108573-3Report Type:Expedited (15-DaCompany Report #HQ2383021JUN2001 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Foreign Loxapac (Loxapine, ) PS ORAL SEE IMAGE Health Risperdal Professional (Risperidone,) SS ORAL SEE IMAGE Temesta (Lorazepam) C Atarax (Hydroxyzine Hydrochloride) C Imovane (Zopiclone) C Depamide (Valpromide) C Date:05/07/03ISR Number: 4109126-3Report Type:Expedited (15-DaCompany Report #FRWYE111929APR03 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Seresta (Oxazepam, Initial or Prolonged Eosinophil Count Health Tablet, 0) PS ORAL ORAL 39 DAY Increased Professional Athymil (Mianserin Hepatic Lesion Other Hydrochloride, 0) SS ORAL ORAL 39 DAY Hepatitis Cholestatic Augmentin Oral Neutrophil Count (Amoxicillin Decreased Trihydrate/Clavulana te Potassium, 0) SS ORAL 1 DOSE 3 X PER 1 22-Feb-2006 08:20 AM Page: 1620 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY,ORAL 24 DAY Ciflox (Ciprofloxacin, 0) SS ORAL 500 MG 2 X PER 1 DAY, ORAL 24 DAY Risperdal (Risperidone, 0) SS ORAL 1 MG 2 X PER 1 DAY, ORAL 8 DAY Tiapridal (Tiapride, 0) SS ORAL ORAL 43 DAY Hepatic Lesion Nos(Llt:Hepatic Lesion Nos) C Date:05/07/03ISR Number: 4109715-6Report Type:Expedited (15-DaCompany Report #NSADSS2002003431 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Prozac (Fluoxetine Hydrochloride) C Wellbutrin (Amfebutamone Hydrochloride) C Zocor (Simvastatin) C Insulin (Insulin) C Accupril (Quinapril Hydrochloride) C Avandia (Rosiglitazone Hydrochloride) C Lasix (Furosemide) C K-Dur (Potassium Chloride) C Viox (Rofecoxib) C Date:05/07/03ISR Number: 4109716-8Report Type:Expedited (15-DaCompany Report #NSADSS2003021376 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:05/08/03ISR Number: 4108887-7Report Type:Direct Company Report #CTU 115290 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Paxil 40mg Tablets, Mfd By Skb PS Skb Risperdal 4mg Tablets, Mfd By Janssen SS Janssen 22-Feb-2006 08:20 AM Page: 1621 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/03ISR Number: 4110093-7Report Type:Expedited (15-DaCompany Report #APCDSS2003000294 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Foreign Risperdal Arrhythmia Consumer (Unspecified) Blood Alkaline Health (Risperidone) PS GRADUALLY Phosphatase Increased Professional INCREASED TO Blood Urea 2 MG MANE AND Circulatory Collapse 3 MB NOCTE Dystonia Ibesartan/Hydrochlor Myocardial Ischaemia othiazide Rash (Irbesartan/Hydrochl Tremor orothiazide) C Epilim (Valproate Sodium) C Aspirin (Acetylsalicylic Acid) C Date:05/08/03ISR Number: 4110094-9Report Type:Expedited (15-DaCompany Report #EMADSS2003003708 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Risperdal (1 Mg Initial or Prolonged Condition Aggravated Health Tablet) Professional (Risperidone) PS ORAL 0.5 MG, 2 IN 1 DAY(S), ORAL Date:05/08/03ISR Number: 4110143-8Report Type:Expedited (15-DaCompany Report #NSADSS2003021392 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Monoplegia Consumer Risperdal (Unspecified) (Risperidone) PS ORAL ORAL Date:05/09/03ISR Number: 4110282-1Report Type:Expedited (15-DaCompany Report #EMADSS2003003727 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal Mental Disorder Health (Unspecified) Neutrophil Count Professional (Risperidone) PS Decreased Convulex (Valproate Platelet Count Decreased Sodium) SS 300 MG, White Blood Cell Count DAILY; SEE Decreased IMAGE Remeron (Mirtazapine) SS 30 MG, DAILY Atarax (Hydroxyzine Hydrochloride) C Co Reniten (Vaseretic) C Entumin (Clotiapine) C Tramal (Tramadol Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1622 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/09/03ISR Number: 4110283-3Report Type:Expedited (15-DaCompany Report #EMADSS2003003719 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS 6 MG, 1 IN 1 TIME(S) Clopixol (Zuclopenthixol Decanoate) SS ORAL 40 MG, DAILY, ORAL; SEE IMAGE Temesta (Lorazepam) SS 4.5, DAILY Konakion (Phytomenadione) C Date:05/09/03ISR Number: 4110440-6Report Type:Expedited (15-DaCompany Report #2002-104635-ML M0437-2003 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Condition Aggravated Health Mirtazapine PS ORAL Leukopenia Professional Valproate Sodium SS Thrombocytopenia Risperidone SS Date:05/09/03ISR Number: 4110466-2Report Type:Expedited (15-DaCompany Report #APCDSS2003000581 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Foreign Risperidone (Tablet) Initial or Prolonged Intentional Overdose Health (Risperidone) PS ORAL 100 TABLE, 1 Rhabdomyolysis Professional IN 1 TIME(S), Suicide Attempt ORAL Caffeine Anhydrous (Caffeine) C Date:05/09/03ISR Number: 4110648-XReport Type:Expedited (15-DaCompany Report #NSADSS2003021385 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal ( 3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, DAILY, ORAL Date:05/09/03ISR Number: 4110649-1Report Type:Expedited (15-DaCompany Report #NSADSS2003021384 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1623 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/03ISR Number: 4110839-8Report Type:Expedited (15-DaCompany Report #NSADSS2003021746 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal Professional (Unspecified) Company (Risperidone) PS ORAL ORAL Representative Depakote(Valproate Semisodium) C Date:05/12/03ISR Number: 4110862-3Report Type:Direct Company Report #CTU 192723 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Risperidone 1 Mg PS ORAL 4 MG QD Initial or Prolonged ORAL Date:05/12/03ISR Number: 4111233-6Report Type:Expedited (15-DaCompany Report #EMADSS2003003741 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cholestasis Foreign Risperidone Hospitalization - Pruritus Health (Unspecified) Initial or Prolonged Rash Maculo-Papular Professional (Risperidone) PS ORAL ORAL Triatec (Ramipril) SS ORAL 5 MG, DAILY, ORAL Augmentin (Clavulin) SS ORAL 2 G, DAILY, ORAL Date:05/12/03ISR Number: 4111296-8Report Type:Expedited (15-DaCompany Report #NSADSS2003022088 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Risperdal(1 Mg/Ml Professional Solution) (Risperidone) PS ORAL 10 ML, ORAL Date:05/13/03ISR Number: 4111882-5Report Type:Expedited (15-DaCompany Report #APCDSS2003000381 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ileus Foreign Risperidone (Tablet) Neuroleptic Malignant Health (Risperidone) PS ORAL 1 MG, DAILY, Syndrome Professional ORAL Zopiclone (Zopiclone) C Donepezil Hydrochloride (Donepezil Hydrochloride) C Date:05/14/03ISR Number: 4112331-3Report Type:Expedited (15-DaCompany Report #200311867FR Age:93 YR Gender:Female I/FU:I Outcome PT Hospitalization - Cardiac Failure Initial or Prolonged Condition Aggravated 22-Feb-2006 08:20 AM Page: 1624 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Lung Disorder Rectal Neoplasm Report Source Product Role Manufacturer Route Dose Duration Foreign Furosemide (Lasilix) Other Solution For Injection PS INTRAVENOUS 20 MG QD; IV 3 DAY Terbutaline Sulfate (Bricanyl )Aerosol (Suspension) SS RESPIRATORY (INHALATION) 1 U TID; INH 12 DAY Ipratropium Bromide (Atrovent) Aerosol (Emulsion) SS RESPIRATORY (INHALATION) 1 U TID; INH 12 DAY Heparin Sodium Solution For Injection SS INTRAVENOUS 60 MG QD; IV 3 DAY Digoxin (Digoxine Nativelle) Solution For Injection SS RESPIRATORY (INHALATION) 0.25 MG BID; IV 1 DAY Risperidone (Risperdal) Coated Tablets SS ORAL 0.5 MG BID; PO Date:05/14/03ISR Number: 4112608-1Report Type:Expedited (15-DaCompany Report #DEWYE007403FEB03 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Trevilor Initial or Prolonged Bowel Sounds Abnormal Professional (Venlafaxine Other Convulsion Hydrochloride, Extensor Plantar Response Tablet, 0) PS ORAL 80 TABLETS Hypotension (OVERDOSE Intentional Overdose AMOUNT Respiratory Failure 4000MG) ORAL 1 DAY Somnolence Risperdal Tachycardia (Risperidone, 0) SS ORAL 60 TABLETS (OVERDOSE AMOUNT 60MG) ORAL 1 DAY Date:05/14/03ISR Number: 4114067-1Report Type:Direct Company Report #CTU 193043 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Risperdal 2mg Hs PS ORAL 2MG HS ORAL 48 HR Swollen Tongue Hydroxyzine C Paxil C Trazodone C 22-Feb-2006 08:20 AM Page: 1625 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/03ISR Number: 4109982-9Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0040772A Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Quilonum Retard PS Glaxosmithkline ORAL 900MG per day HR Initial or Prolonged Intentional Overdose Atarax SS ORAL 50MG per day HR Somnolence Dipiperon SS ORAL 320MG per day HR Suicide Attempt Fluoxetin SS ORAL 60MG per day HR Risperdal SS ORAL 6MG per day HR Date:05/15/03ISR Number: 4112764-5Report Type:Expedited (15-DaCompany Report #NSADSS2003021501 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Tablet) (Risperidone) PS ORAL 0.5 MG, 2 IN DAILY, ORAL Date:05/15/03ISR Number: 4112767-0Report Type:Expedited (15-DaCompany Report #NSADSS2003022339 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Risperdal (1 Mg Congestive Professional Tablet) (Risperidone) PS ORAL 1 MG, DAILY, ORAL Date:05/15/03ISR Number: 4112772-4Report Type:Expedited (15-DaCompany Report #NSADSS2003022366 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, 2 IN 1 DAY(S), ORAL Date:05/15/03ISR Number: 4112808-0Report Type:Expedited (15-DaCompany Report #2001-00143 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pyrexia Foreign Loxitane (Loxapac) Rhabdomyolysis Health (Watson Professional Laboratories)(Loxapi Company ne Succinate) Representative Unknown PS ORAL SEE IMAGE Other Risperdal (Risperidone) () SS ORAL SEE IMAGE Temesta (Lorazepam) C Atarax (Hydroxyzine) C Imovan (Zopiclone) C Depamide (Vallpromide) C 22-Feb-2006 08:20 AM Page: 1626 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/15/03ISR Number: 4112972-3Report Type:Expedited (15-DaCompany Report #EMADSS2003003813 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Risperdal Syndrome Health (Unspecified) Professional (Risperidone) PS 1 MG, 2 IN 1 DAY(S) Oxazepamum (Oxazepam) C Date:05/15/03ISR Number: 4113486-7Report Type:Expedited (15-DaCompany Report #FRWYE111929APR03 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Seresta (Oxazepam, Initial or Prolonged Eosinophil Count Professional Tablet, 0) PS ORAL ORAL 39 DAY Increased Other Athymil (Mianserin Hepatic Lesion Hydrochloride, 0) SS ORAL 1 DOSE 3X PER Hepatitis Cholestatic 1 DAY ORAL 39 DAY Neutrophil Count Augmentin Oral Decreased (Amoxicillin Trihydrate/Clavulana te Potassium, 0) SS ORAL 1 DOSE 3X PER 1 DAY ORAL 24 DAY Ciflox (Ciprofloxacin, 0) SS ORAL 500 MG 2X PER 1 DAY ORAL 24 DAY Risperdal (Risperidone,0) SS ORAL 1 MG 2X PER 1 DAY ORAL 8 DAY Tiapridal (Tiapride,0) SS ORAL ORAL Imovane (Zopiclone) C Tranxene (Clorazepate Dipotassium) C Date:05/16/03ISR Number: 4113590-3Report Type:Expedited (15-DaCompany Report #EMADSS2003002089 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Foreign Risperdal (1 Mg Initial or Prolonged Condition Aggravated Health Tablet) Professional (Risperidone) PS ORAL 1 MG, DAILY, ORAL Seroxat (Paroxetine Hydrochloride) SS ORAL 40 MG, DAILY, ORAL Beloc Mite (Metoprolol Tartrate) SS ORAL 95 MG, DAILY, ORAL Diazepam C Norvasc (Amlodipine Besilate) C Hct Hexal (Hexachlorophene) C Lozaar 50 (Lozar) C Euthyrox 22-Feb-2006 08:20 AM Page: 1627 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Levothyroxine Sodium) C Date:05/16/03ISR Number: 4113593-9Report Type:Expedited (15-DaCompany Report #EMADSS2003003910 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Foreign Risperdal Initial or Prolonged Somnolence Consumer (Unspecified) (Risperidone) PS 0.5 ML, DAILY Date:05/19/03ISR Number: 4114476-0Report Type:Direct Company Report #CTU 193273 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Risperdal 2mg Po Bid PS Intervention to Prozac C Prevent Permanent Benadryl C Impairment/Damage Date:05/19/03ISR Number: 4115271-9Report Type:Expedited (15-DaCompany Report #2003019750 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Sertraline Health (Sertraline) PS ORAL 50 MG Professional (DAILY), ORAL Other Risperidone (Risperidone) SS ORAL 6 MG (DAILY), ORAL Biperiden C Date:05/20/03ISR Number: 4114454-1Report Type:Expedited (15-DaCompany Report #APCDSS2003000649 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Volvulus Of Bowel Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS 6 MG, 1 IN 1 DAY(S), Sodium Valproate (Valoproate Sodium) C Metamucil (Psyllium Hydrophilic Mucilloid) C Alendronate (Alendronate Sodium) C Premia 5 (Provette / Generic/) C Frusemide (Furosemide) C Poly-Tears (Tears Naturale) C Phenytoin (Phenytoin) C Paracetamol (Paracetamol) C 22-Feb-2006 08:20 AM Page: 1628 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/20/03ISR Number: 4114455-3Report Type:Expedited (15-DaCompany Report #EMADSS2002003487 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infertility Female Foreign Risperdal Pituitary Tumour Benign Health (Unspecified) Professional (Risperidone) PS 2 MG, Cipramil (Citalopram) C Date:05/20/03ISR Number: 4114459-0Report Type:Expedited (15-DaCompany Report #APCDSS2003000557 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dialysis Foreign Risperidone (Tablet) Hospitalization - Disorientation Health (Risperidone) PS ORAL 3 MG, DAILY, Initial or Prolonged Hyperkalaemia Professional ORAL Required Liver Disorder Tiapride Intervention to Loss Of Consciousness Hydrochloride Prevent Permanent Renal Disorder (Tiapride Impairment/Damage Rhabdomyolysis Hydrochloride) SS ORAL 100 MG, White Blood Cell Count DAILY, ORAL Increased Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS ORAL 25 MG, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Magnesium Oxide (Magnesium Oxide) C Lactulose (Lactulose) C Aminoleban (Aminoleban) C Cimetidine (Cimetidine) C Date:05/20/03ISR Number: 4114486-3Report Type:Expedited (15-DaCompany Report #NSADSS2003023056 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Foreign Risperdal Decreased Health (Risperidone) PS RISPERDAL 1 Professional MG - AM Benztropine C Date:05/20/03ISR Number: 4114488-7Report Type:Expedited (15-DaCompany Report #EMADSS2003002021 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autonomic Nervous System Foreign Risperdal (2 Mg Initial or Prolonged Imbalance Health Tablet) Fatigue Professional (Risperidone) PS ORAL 2 MG DAILY Myalgia ORAL Somnolence Lysanxia (Prazepam) C Speech Disorder Doversyl Tremor (Perindopril) C 22-Feb-2006 08:20 AM Page: 1629 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxeol (Bambuterol Hydrochloride) C Date:05/20/03ISR Number: 4114614-XReport Type:Direct Company Report #CTU 193405 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyspnoea Risperidone PS 1MG BID Intervention to Speech Disorder Prevent Permanent Swollen Tongue Impairment/Damage Date:05/20/03ISR Number: 4114783-1Report Type:Direct Company Report #CTU 193475 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperidone PS 0.25 MG BID Initial or Prolonged Phosphokinase Increased Neuroleptic Malignant Syndrome Pyrexia Respiratory Failure Date:05/20/03ISR Number: 4114784-3Report Type:Direct Company Report #CTU 193476 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Risperidone PS 1 MG TID Eyelid Disorder Date:05/20/03ISR Number: 4114785-5Report Type:Direct Company Report #CTU 193477 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperidone PS ORAL 3MG BID PO Initial or Prolonged Phosphokinase Increased Dysphagia Neuroleptic Malignant Syndrome Date:05/20/03ISR Number: 4114786-7Report Type:Direct Company Report #CTU 193486 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Risperidone PS 4 MG BID - PREVIOUSLY 0.5 MG TID Date:05/20/03ISR Number: 4114827-7Report Type:Direct Company Report #CTU 193485 Age: Gender:Male I/FU:I Outcome PT Other Asthenia Convulsion Drooling 22-Feb-2006 08:20 AM Page: 1630 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gait Disturbance Muscle Rigidity Report Source Product Role Manufacturer Route Dose Duration Risperidone PS 1 MG QHS Date:05/20/03ISR Number: 4114843-5Report Type:Direct Company Report #CTU 193510 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Risperidone PS ORAL 0.25 MG QD PO Initial or Prolonged Syndrome 1 MG QHS Date:05/20/03ISR Number: 4115429-9Report Type:Expedited (15-DaCompany Report #NSADSS2003020111 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abortion Spontaneous Study Risperdal (Tablet) Blood Human Chorionic Health (Risperidone) PS ORAL 2 MG, DAILY, Gonadotropin Professional ORAL Complications Of Maternal Olanzapine Exposure To Therapeutic (Olanzapine) C Drugs Mellaril Hypersomnia (Thioridazine Intra-Uterine Death Hydrochloride) C Maternal Drugs Affecting Zoloft (Sertraline Foetus Hydrochloride) C Muscle Spasms Prevacid Overdose (Lansoprazole) C Pregnancy Trazodone Sedation (Trazodone) C Vaginal Haemorrhage Vaginitis Bacterial Vomiting Date:05/20/03ISR Number: 4115432-9Report Type:Expedited (15-DaCompany Report #NSADSS2003016036 Age:95 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal Dementia Alzheimer'S Type Professional (Unspecified) (Risperidone) PS Date:05/20/03ISR Number: 4115433-0Report Type:Expedited (15-DaCompany Report #NSADSS2003022721 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:05/21/03ISR Number: 4116036-4Report Type:Direct Company Report #CTU 193702 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperpyrexia Risperidone PS 4 MG QHS 1 DAY Pyrexia Lithium SS 900 MG/DAY 1 DAY 22-Feb-2006 08:20 AM Page: 1631 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Albuterol/Atrovent Inhaler C Enalapril C Kcl C Date:05/22/03ISR Number: 4116143-6Report Type:Expedited (15-DaCompany Report #NSADSS2003023901 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Generalised Oedema Health Risperdal Oedema Peripheral Professional (Unspecified) (Risperidone) PS Date:05/22/03ISR Number: 4116145-XReport Type:Expedited (15-DaCompany Report #NSADSS2003023892 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Valve Disease Consumer Risperdal (0.5 Mg Cardiac Failure Tablet) Congestive (Risperidone) PS ORAL 0.5 MG 1 IN 1 NIGHT (S) ORAL Date:05/22/03ISR Number: 4116146-1Report Type:Expedited (15-DaCompany Report #NSADSS2003023734 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG DAILY ORAL Date:05/22/03ISR Number: 4116196-5Report Type:Expedited (15-DaCompany Report #NSADSS2003023207 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:05/22/03ISR Number: 4116479-9Report Type:Expedited (15-DaCompany Report #NSADSS2003023066 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Haemorrhage Consumer Risperdal Initial or Prolonged (Risperidone) PS ORAL ORAL Other Klonopin (Clonazepam) C Doxepin (Doxepin) C 22-Feb-2006 08:20 AM Page: 1632 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/22/03ISR Number: 4116510-0Report Type:Expedited (15-DaCompany Report #EMADSS2003004117 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Urine Present Foreign Risperidone Health (Risperidone) PS 0.5 MG, DAILY Professional Date:05/22/03ISR Number: 4116524-0Report Type:Expedited (15-DaCompany Report #EMADSS2003003918 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Foreign Risperdal Sepsis Health (Unspecified) Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY(S), ORAL Valproic Acid (Valproic Acid) SS ORAL 250 MG, 3 IN 1 DAY(S), ORAL Venlafaxine (Venlafaxine) C Date:05/22/03ISR Number: 4116709-3Report Type:Expedited (15-DaCompany Report #PHRM2003FR01445 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Haemorrhage Foreign Lopressor Initial or Prolonged Ischaemic Stroke Health (Metoprolol Professional Tartrate) Other Film-Coated Tablet PS ORAL 200 MG, QD, ORAL Imovane (Zopiclone) Tabelt SS ORAL 75 MG, QD, ORAL Risperdal (Risperidone) SS ORAL 5 MG, QD, ORAL Reminyl (Galantamine) Tablet SS ORAL 16 MG, QD, ORAL Memantine (Memantine) SS ORAL 5MG, QD, ORAL Date:05/22/03ISR Number: 4117275-9Report Type:Direct Company Report #USP 51082 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Risperdal PS Janssen Pharm. LIQUID Overdose Date:05/22/03ISR Number: 4118345-1Report Type:Direct Company Report #CTU 193773 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Unevaluable Event Resperdal 3 Mg PS 2 TIMES A DAY 22-Feb-2006 08:20 AM Page: 1633 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/23/03ISR Number: 4116922-5Report Type:Expedited (15-DaCompany Report #APCDSS2003000556 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Risperidone(Tablet)R Hospitalization - Complete Health isperidone) PS ORAL 1 MG, DAILY, Initial or Prolonged Blood Creatine Professional ORAL; 2 MG, Required Phosphokinase Increased DAILY, ORAL Intervention to Blood Pressure Decreased Haldol(Injection)(Ha Prevent Permanent Cardio-Respiratory Arrest loperidol) SS INTRAVENOUS 5 MG, DAILY, Impairment/Damage Delirium IV Depressed Level Of Mianserin Consciousness Hydrochloride(Mianse Dialysis rin Hydrochloride) SS ORAL 10 MG, DAILY, Hepatic Steatosis ORAL Insomnia Brotizolam(Brotizola Kidney Enlargement m) C Muscle Disorder Bromvalerylurea(Brom Renal Failure Acute isoval) C Respiratory Disorder Lormetazepam(Lormeta Sleep Phase Rhythm zepam) C Disturbance Zolpidem Soliloquy Tartrate(Zolpidem Suicidal Ideation Tartrate) C Suicide Attempt Hydrocortisone(Hydro cortisone) C Levothyroxyne Sodium(Levothyroxine Sodium) C Desmopressin Acetate(Desmopressio n Acetate) C Theophylline(Theophy lline) C Rinderon- Vg(Valisone-G) C Clobetasone Butyrate(Clobetasone Butyrate) C Trazodone Hydrochloride(Trazod one Hydrochloride) C Dydrogesterone (Dydrogesterone) C Pravastatin Sodium(Pravastatin Sodium) C Hydrocortisone Sodium Succinate(Hydrocorti sone Sodium Succinate) C Date:05/23/03ISR Number: 4117018-9Report Type:Expedited (15-DaCompany Report #NSADSS2003023973 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (4 Mg Professional Tablet) (Risperidone) PS ORAL 4 MG, 2 IN 24 HOUR (S), 22-Feb-2006 08:20 AM Page: 1634 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:05/23/03ISR Number: 4117169-9Report Type:Expedited (15-DaCompany Report #NSADSS2003023571 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Health Risperdal Decreased Professional (Unspecified) White Blood Cell Count (Risperidone) PS ORAL 1.5 MG, Decreased DAILY, ORAL Concerta (Methylphenidate Hydrochloride) SS ORAL 36 MG, 1 IN 1 DAY(S), ORAL Date:05/23/03ISR Number: 4117187-0Report Type:Expedited (15-DaCompany Report #NSADSS2003023742 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pyrexia Health Risperdal Rhabdomyolysis Professional (Unspecified) (Risperidone) PS ORAL 16 MG, DAILY, ORAL Loxapac (Loxapine Succinate) SS ORAL DAILY, ORAL Atarax (Hydroxyzine Hydrochloride) C Imovan (Zopiclone) C Depamide (Valpromide) C Temesta (Lorazepam) C Date:05/27/03ISR Number: 4115923-0Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0299655A Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cholestasis Consumer Augmentin PS Glaxosmithkline ORAL 2G per day 8 DAY Hospitalization - Pruritus Risperdal SS ORAL 1UNIT Twice Initial or Prolonged Rash Maculo-Papular per day 10 DAY Triatec SS ORAL 5MG Per day 21 DAY Corticoids C ORAL Date:05/27/03ISR Number: 4118066-5Report Type:Expedited (15-DaCompany Report #2003021089 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Zithromax (Caps) Drug Interaction Professional (Azitrhomycin) PS UNKNOWN 500 MG Hyperhidrosis (UNKNOWN), Ventricular Extrasystoles UNKNOWN Risperidone (Risperidone) SS UNKNOWN UNK (UNKNOWN), UNKNOWN Docusate Sodium C Paroxetine Hydrochloride C Bupropion 22-Feb-2006 08:20 AM Page: 1635 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride C Date:05/27/03ISR Number: 4119213-1Report Type:Direct Company Report #CTU 193980 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Risperidol 0.5 Confusional State Janssen PS Janssen ORAL 1 BID/T Disorientation ORAL Faecal Incontinence Reminyl C Hostility Lvoxyl C Incontinence Verapamil C Paranoia Hctz C Personality Change Fosamax C Date:05/28/03ISR Number: 4119074-0Report Type:Expedited (15-DaCompany Report #EMADSS2003004249 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Foreign Risperdal (2 Mg Initial or Prolonged Positive Health Tablet) Rhabdomyolysis Professional (Risperidone) PS ORAL 2 MG, DAILY, ORAL; 4 MG DAILY, ORAL Zyprexa (Olanzapine) SS 15 MG, DAILY, UNKNOWN L-Thyroxin (Levothyroxine Sodium) C Date:05/29/03ISR Number: 4119397-5Report Type:Direct Company Report #CTU 194262 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Amenorrhoea Risperidone PS 0.5 MG AM AND Blood Prolactin Increased 1 MG HS 1 YR Menstruation Irregular Clomipramine C Buspirone C Senokot C Fibercon C Date:05/29/03ISR Number: 4119406-3Report Type:Direct Company Report #CTU 194251 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Salivary Hypersecretion Risperidal PS ORAL .25MG BID (PO) Date:05/29/03ISR Number: 4119474-9Report Type:Direct Company Report #CTU 194228 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Back Pain Risperdal 4 Mg PS ORAL 4MG PO Q HS Dystonia Risperdal 1 Mg SS ORAL 1MG PO Q AM Neck Pain 22-Feb-2006 08:20 AM Page: 1636 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/03ISR Number: 4119971-6Report Type:Expedited (15-DaCompany Report #NSADSS2002002607 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Risperdal (Tablet) Initial or Prolonged Cogwheel Rigidity Professional (Risperidone) PS ORAL SEE IMAGE Drooling Tegretol Drug Interaction (Carbamazepine) SS ORAL 1200 MG, 1 IN Drug Level Decreased 1 DAY, ORAL Enzyme Induction Lamotrigine Influenza (Lamotrigine) C Lethargy Liver Function Test Abnormal Malaise Somnolence Tremor Date:05/29/03ISR Number: 4119973-XReport Type:Expedited (15-DaCompany Report #NSADSS2003023972 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Risperdal (1mg Anorexia Professional Tablet) Fatigue (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY(S), ORAL Klonopin (Clonazepam) C Abilify (Aripiprazole) C Depo Provera (Medroxyprogesterone Acetate) C Date:05/29/03ISR Number: 4119977-7Report Type:Expedited (15-DaCompany Report #NSADSS2003024257 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS 3MG, 1 IN 1 DAY(S), ORAL Date:05/29/03ISR Number: 4119979-0Report Type:Expedited (15-DaCompany Report #NSADSS2003024260 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, 2 IN 1 DAY(S), ORAL Date:05/29/03ISR Number: 4120040-XReport Type:Expedited (15-DaCompany Report #APCDSS2003000581 Age:25 YR Gender:Female I/FU:F Outcome PT Hospitalization - Borderline Personality Initial or Prolonged Disorder 22-Feb-2006 08:20 AM Page: 1637 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diabetic Ketoacidosis Overdose Rhabdomyolysis Report Source Product Role Manufacturer Route Dose Duration Suicide Attempt Foreign Risperidone (Tablet) Health (Risperidone) PS ORAL 100 TABLE, 1 Professional IN 1 TIME(S), ORAL Caffeine Anhydrous (Caffeine) C Date:05/29/03ISR Number: 4120048-4Report Type:Expedited (15-DaCompany Report #2003CG00601 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Mopral PS ORAL 1 DF DAILY PO Initial or Prolonged Nausea Health Imovane SS ORAL 7.5 MG DAILY Weight Decreased Professional PO Other Levothyrox SS ORAL 50 UG DAILY PO Risperdal SS ORAL 0.75 MG DAILY PO Equanil SS ORAL 1 G DAILY PO Aricept SS ORAL 10 MG DAILY PO Date:05/29/03ISR Number: 4120360-9Report Type:Expedited (15-DaCompany Report #K200300817 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cholestasis Foreign Altace Capsules Hospitalization - Rash Maculo-Papular Health (Ramipril) PS ORAL 5 MG, ORAL Initial or Prolonged Professional Augmentin Other (Amoxicillin Trihydrate, Clavulanate Potassium) SS ORAL 2 G, QD, ORAL Risperdal (Risperidone) SS ORAL 2 U, QD, ORAL Corticosteroid Nos (Corticosteroid Nos) C Date:05/29/03ISR Number: 4121054-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12221008 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hallucination, Auditory Abilify Tabs PS Otsuka Mood Altered Pharmaceutical Speech Disorder Company, Ltd. ORAL Started 15mg Dec-02,then 1 wk ago, dose increased to 1-15mg tab + 1 WK Risperdal SS Depakote C Cogentin C 22-Feb-2006 08:20 AM Page: 1638 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/30/03ISR Number: 4119472-5Report Type:Expedited (15-DaCompany Report #FR-ROCHE-338617 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Valium PS Roche ORAL 28 DAY Initial or Prolonged Diarrhoea Allopurinol SS Roche UNKNOWN Pruritus Inipomp SS UNKNOWN Pyrexia Ostram SS UNKNOWN Rash Macular Nicobion SS UNKNOWN Rash Pustular Risperdal SS UNKNOWN Avlocardyl SS ORAL Duphaston 10 SS ORAL Effexor SS UNKNOWN Depakote SS UNKNOWN Date:05/30/03ISR Number: 4120649-3Report Type:Expedited (15-DaCompany Report #NSADSS2003024530 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Risperdal Decreased Professional (Unspecified) (Risperidone) PS Date:05/30/03ISR Number: 4121313-7Report Type:Expedited (15-DaCompany Report #FRWYE102622APR03 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cyanosis Health Seresta (Oxazepam, Life-Threatening Foreign Body Aspiration Professional Tablet, 0) PS ORAL 50 MG 1X PER Other 1 DAY 1344 DAY Driptane (Oxybutynin Hydrochloride) SS ORAL 5 MG 3X PER 1 DAY 1435 DAY Gardenal (Phenobarbital) SS ORAL 50 MG 1X PER 1 DAY 1191 DAY Imovane (Zopiclone) SS ORAL 7.5 MG 1X PER 1 DAY 1435 DAY Noctran 10 (Acepromazine/Acepro metazine/Clorazepate Dipotassium) SS ORAL 10 MG 1X PER 1 DAY 674 DAY Risperdal (Risperidone) SS ORAL 4 MG 1X PER 1 DAY 1191 DAY Coaprovel (Irbesartan/Hydrochl orothiazide) C Hyperium (Rilmenidine) C Zyrtec (Cetirizine Hydrochloride) C Tardyferon (Ferrous Sulfate) C Ginkor (Ginkgo Tree Leaves Extract/Troxerutin) C Voltaren Emulgel (Diclofenac 22-Feb-2006 08:20 AM Page: 1639 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diethylamine) C Biafine (Cetyl Palmitate/Ethylene Glycol Monosterate/Paraffin /Paraffin, C Art 50 (Diacerein) C Forlax (Macrogol) C Normacol (Frangula Extract/Sterculia) C Levophta (Levocabastine Hydrochloride) C Dextropropoxyphene/ Paracetamol (Dextropropoxyphene/ Paracetamol) C Date:05/30/03ISR Number: 4121339-3Report Type:Expedited (15-DaCompany Report #APCDSS2003000725 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperidone Initial or Prolonged Tardive Dyskinesia Health (Unspecified) Required Professional (Risperidone) PS ORAL 4 MG, DAILY, Intervention to ORAL Prevent Permanent Etizolam (Etizolam) C Impairment/Damage Flunitrazepam (Flunitrazepam) C Date:05/30/03ISR Number: 4121340-XReport Type:Expedited (15-DaCompany Report #APCDSS2003000726 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Benign Foreign Risperidone Health (Unspecified) Professional (Risperidone) PS ORAL 3 MG, 1 IN 1 DAY(S), ORAL Bromocriptine (Bromocriptine) C Date:05/30/03ISR Number: 4121453-2Report Type:Expedited (15-DaCompany Report #APCDSS2003000728 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Benign Foreign Risperidone Health (Unspecified) Professional (Risperidone) PS ORAL 2 MG, 1 IN 1 DAY (S), ORAL Date:06/02/03ISR Number: 4121888-8Report Type:Expedited (15-DaCompany Report #03P-167-0219642-00 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Septic Shock Foreign Valproic Acid White Blood Cell Count Health (Depakene) (Valproic Decreased Professional Acid) (Valproic Acid) PS ORAL 250 MG, 3 IN 22-Feb-2006 08:20 AM Page: 1640 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 D, ORAL Risperidone SS ORAL 1 MG, 2 IN 1 D, ORAL Venlafaxine C Date:06/02/03ISR Number: 4122165-1Report Type:Expedited (15-DaCompany Report #HQWYE340523MAY03 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Effexor Xr Initial or Prolonged Drug Interaction (Venlafaxine Medication Error Hydrochloride, Somnolence Capsule, Extended Release) PS ORAL SEE IMAGE Risperdal (Risperidone,) SS 0.25 MG 1X PER 1 DAY Strattera (Atomoxetine Hydrochloride,) SS 80 MG 1X PER 1 DAY Date:06/03/03ISR Number: 4122285-1Report Type:Direct Company Report #CTU 194685 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebral Atrophy Haldol PS FORCED ON Hospitalization - Nervous System Disorder Resperidol SS Initial or Prolonged Disability Other Required Intervention to Prevent Permanent Impairment/Damage Date:06/03/03ISR Number: 4123123-3Report Type:Expedited (15-DaCompany Report #EMADSS2003004289 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal (1 Mg Initial or Prolonged Depressed Level Of Health Tablet) Consciousness Professional (Risperidone) PS ORAL 1 MG, DAILY; Fall ORAL Haemodialysis Melleril Hyperkalaemia (Thioridazine Hypertension Hydrochloride) SS ORAL 35 DROP, Hypothermia NIGHT(S); Indifference ORAL Malaise Lopril (Captopril) C Pupils Unequal Renal Failure Acute Rhabdomyolysis 22-Feb-2006 08:20 AM Page: 1641 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/03ISR Number: 4123133-6Report Type:Expedited (15-DaCompany Report #EMADSS2003000486 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blepharospasm Foreign Risperdal Dystonia Health (Unspecified) Torticollis Professional (Risperidone) PS ORAL 2 MG, DAILY; ORAL Date:06/03/03ISR Number: 4123134-8Report Type:Expedited (15-DaCompany Report #EMADSS2003004401 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Foreign Risperdal Multiple Sclerosis Health (Unspecified) Professional (Risperidone) PS ORAL UNK; ORAL Date:06/03/03ISR Number: 4123158-0Report Type:Expedited (15-DaCompany Report #EMADSS2003003657 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal (Unspecified) (Risperidone) PS Date:06/03/03ISR Number: 4123160-9Report Type:Expedited (15-DaCompany Report #EMADSS2003004300 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Foreign Risperdal (2 Mg Somnolence Health Tablet) Professional (Risperidone) PS ORAL 2 MG, 1 IN 1 TIME(S), ORAL Atarax (Hydroxzine Hydrochloride) SS ORAL 25 MG, 1 IN 1 TIME(S), ORAL Tercian (Cyamemazine) SS ORAL 25 MG, 1 IN 1 TIME(S), ORAL Lepticur (Tropatepine Hydrochloride) SS ORAL 10 MG, 1 IN 1 ORAL TIME(S), ORAL Equanil (Meprobamate) C Tanakan (Ginkgo Tree Leaves Extract) C Date:06/03/03ISR Number: 4123161-0Report Type:Expedited (15-DaCompany Report #EMADSS2003004392 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal Galactorrhoea Health (Unspecified) Pituitary Tumour Professional (Risperidone) PS ORAL 6 MG, DAILY, ORAL 22-Feb-2006 08:20 AM Page: 1642 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/03ISR Number: 4123220-2Report Type:Expedited (15-DaCompany Report #NSADSS2003024690 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Risperdal (1 Mg Professional Tablet) (Risperidone) PS ORAL 1 MG, 1 IN 1 DAY(S), ORAL Date:06/04/03ISR Number: 4123184-1Report Type:Direct Company Report #CTU 194964 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Risperidone, Janssen PS Janssen 2MG BY MOUTH Required Movement Disorder TWICE DAILY 5 MON Intervention to Klonopin C Prevent Permanent Cardura C Impairment/Damage Prutonix C Date:06/04/03ISR Number: 4123654-6Report Type:Direct Company Report #CTU 195027 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Lithium Carbonate Initial or Prolonged 300mg Cap PS 600MG BID BY MOUTH Risperidone SS ORAL 1.5MG BID BY MOUTH (PO) Lovastatin C Irbesartan C Benztropine Mesylate C Vitamin E C Perphenazine C Psyllium Sf C Amoxicillin 875/Clavulanate K C Docusate Sodium (Colace) C Lorazepam (Ativan) C Date:06/04/03ISR Number: 4124375-6Report Type:Expedited (15-DaCompany Report #EMADSS2003002021 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Foreign Risperdal(2 Mg Initial or Prolonged Impaired Self-Care Health Tablet)(Risperidone) PS ORAL 2 MG, DAILY, Myalgia Professional ORAL; 1 MG, Somnolence DAILY, ORAL Speech Disorder Lysanxia(Prazepam) C Tremor Covesyl(Perindopril) C Oxeol(Bambuterol Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1643 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/03ISR Number: 4124379-3Report Type:Expedited (15-DaCompany Report #APCDSS2003000725 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperidone(Risperid Initial or Prolonged Tardive Dyskinesia Health one) PS ORAL 4 MG, DAILY, Required Professional ORAL Intervention to Etizolam (Etizolam) C Prevent Permanent Flunitrazepam(Flunit Impairment/Damage razepam) C Date:06/04/03ISR Number: 4124490-7Report Type:Expedited (15-DaCompany Report #NSADSS2003024731 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (2 Mg Professional Tablet) (Risperidone) PS ORAL 2 MG, 1 IN 1 TIME(S), ORAL Date:06/04/03ISR Number: 4124572-XReport Type:Expedited (15-DaCompany Report #NSADSS2003024729 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:06/05/03ISR Number: 4123404-3Report Type:Expedited (15-DaCompany Report #WAES 0304USA02922 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Zocor PS Merck & Co., Inc ORAL 1057 DAY Hospitalization - Hypokalaemia Chlorpromazine Initial or Prolonged Myocardial Infarction Hydrochloride SS 1319 DAY Neuroleptic Malignant Zotepine SS 1686 DAY Syndrome Bezafibrate SS ORAL 1389 DAY Pulmonary Infarction Risperidone SS 1686 DAY Quadriplegia Nifedipine C 388 DAY Tachycardia Voglibose C 892 DAY Glyburide C 1207 DAY Date:06/05/03ISR Number: 4123737-0Report Type:Direct Company Report #CTU 195050 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Insomnia Risperdal 1 Mg Medication Error Janssen PS Janssen ORAL 1MG BEDTIME Mental Impairment ORAL Pharmaceutical Product Seroquel 25 Mg Complaint Astrazeneca SS Astrazeneca ORAL 25MG BEDTIME ORAL 22-Feb-2006 08:20 AM Page: 1644 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/03ISR Number: 4123756-4Report Type:Direct Company Report # Age:86.5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Medication Error Riperdal PS 3-24 HRS Alprazolam SS Digoxin SS Date:06/05/03ISR Number: 4124946-7Report Type:Expedited (15-DaCompany Report #NSADSS2003024904 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (3 Mg Professional Tablet) (Risperidone) PS ORAL 3 MG, DAILY, ORAL Date:06/05/03ISR Number: 4124949-2Report Type:Expedited (15-DaCompany Report #NSADSS2003024835 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Rhabdomyolysis Health Risperdal Hospitalization - Professional (Unspecified) Initial or Prolonged (Risperidone) PS Other Geodon SS Required Zoloft (Sertraline Intervention to Hydrochloride) C Prevent Permanent Trileptal Impairment/Damage (Oxcarbazepine) C Dulcolax (Bisacodyl) C Desyrel (Trazodone Hydrochloride) C Vistaril (Hydroxyzine Embonate) C Prolixin Decanoate (Fluphenazine Decanoate) C Date:06/05/03ISR Number: 4124952-2Report Type:Expedited (15-DaCompany Report #NSADSS2003024852 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Risperdal Photosensitivity Reaction Professional (Unspecified) (Risperidone) PS ORAL ORAL Date:06/05/03ISR Number: 4125646-XReport Type:Expedited (15-DaCompany Report #NSADSS2003024826 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Foreign Risperdal Literature (Unspecified) Health (Risperidone) PS ORAL 3 MG, DAILY, Professional ORAL 22-Feb-2006 08:20 AM Page: 1645 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/05/03ISR Number: 4125647-1Report Type:Expedited (15-DaCompany Report #NSADSS2003024839 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocythaemia Foreign Risperdal Health (Unspecified) Professional (Risperidone) PS ORAL 2.5 MG, DAILY, ORAL Date:06/06/03ISR Number: 4123955-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-338617 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Valium PS Roche ORAL 28 DAY Initial or Prolonged Diarrhoea Allopurinol-Ratiopha Drug Eruption rm SS UNKNOWN Pruritus Inipomp SS UNKNOWN Pyrexia Ostram SS UNKNOWN Rash Erythematous Nicobion SS UNKNOWN Rash Macular Risperdal SS UNKNOWN Rash Pustular Avlocardyl SS ORAL Duphaston 10 SS ORAL Effexor SS UNKNOWN Depakote SS UNKNOWN Date:06/06/03ISR Number: 4125444-7Report Type:Expedited (15-DaCompany Report #EMADSS2003004564 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mental Disorder Foreign Risperdal Viral Infection Health (Unspecified) White Blood Cell Count Professional (Risperidone) PS ORAL 2 MG, DAILY, Decreased ORAL 2 YR Vitta-Ferro (Iron) C Date:06/06/03ISR Number: 4125836-6Report Type:Expedited (15-DaCompany Report #EMADSS2003004548 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Foreign Risperidone Fall Health (Unspecified) Musculoskeletal Stiffness Professional (Risperidone) PS ORAL 2 MG 2 IN 1 DAY (S) ORAL Prozac (Fluoxetine Hydrochloride) C Date:06/06/03ISR Number: 4126065-2Report Type:Expedited (15-DaCompany Report #NSADSS2003024993 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal (0.5 Mg Professional Tablet) (Risperidone) PS ORAL 0.5 MG, 1 IN 1 DAY (S), ORAL 22-Feb-2006 08:20 AM Page: 1646 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/03ISR Number: 4126041-XReport Type:Expedited (15-DaCompany Report #APCDSS2003000714 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Maternal Drugs Affecting Foreign Risperdal Foetus Health (Risperidone) PS SEE IMAGE Pregnancy Professional Haldol (Haloperidol) SS 5 MG, DAILY, Respiratory Rate UTERINE Decreased Date:06/09/03ISR Number: 4126229-8Report Type:Expedited (15-DaCompany Report #2003022533 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Literature Hydroxyzine Agitation Health Hydrochloride Anxiety Professional (Tabelt) (Hyrozyzine Asthenia Hydrochloride) PS Atrophy Risperidone Coma (Risperidone0 SS 0.25 MG Condition Aggravated (DAILY) Confusional State Paroxetine Dementia (Paroxetine) SS 10 MG (DAILY) Heart Rate Decreased Quinapril Hyperhidrosis (Quinapril) C Hyperpyrexia Simvastatin Hypomania (Simvastatin) C Hypothermia Haloperidol Lethargy (Haloperidol) C Muscle Rigidity Myoclonus Physical Assault Psychotic Disorder Respiratory Rate Increased Restlessness Serotonin Syndrome Tachycardia Tachypnoea Trismus Date:06/09/03ISR Number: 4126282-1Report Type:Expedited (15-DaCompany Report #APCDSS2003000714 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Haldol (Unspecified) Complications Of Maternal Health (Haloperidol) PS INTRA-UTERINE 5 MG, DAILY, Exposure To Therapeutic Professional UTERINE Drugs Risperdal Maternal Drugs Affecting (Unspecified) Foetus (Risperidone) SS INTRA-UTERINE SEE IMAGE Neonatal Disorder Pregnancy Respiratory Rate Decreased 22-Feb-2006 08:20 AM Page: 1647 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/10/03ISR Number: 4127117-3Report Type:Direct Company Report #CTU 195486 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Discharge Risperdal 2mg Janssen PS Janssen ORAL 2MG BID PO Date:06/10/03ISR Number: 4127118-5Report Type:Direct Company Report #CTU 195487 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Risperdal 1mg Extrapyramidal Disorder Janssen PS Janssen ORAL 1MG BID PO Date:06/10/03ISR Number: 4127536-5Report Type:Expedited (15-DaCompany Report #2003023122 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Foreign Atarax (Tablet) Initial or Prolonged Somnolence Health (Hydroxyzine Professional Hydrochloride) PS ORAL 25 MG (ONCE); ORAL Risperidone (Risperidone) SS ORAL 2 MG (ONCE); ORAL Tropatepine Hydrochloride (Tropatepine Hydrochloride) SS ORAL 10 MG (ONCE); ORAL Cyamemazine (Cyamemazine) SS ORAL 25 MG (ONCE); ORAL Meprobamate C Ginkgo Biloba Extract C Date:06/11/03ISR Number: 4127067-2Report Type:Direct Company Report #CTU 195606 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Abilify 15mg PS ORAL ONCE QAM PO Atrial Tachycardia Risperdal 1.5mg SS ORAL ONCE QHS PO Condition Aggravated Dyspnoea Palpitations Panic Attack Restlessness Date:06/11/03ISR Number: 4128107-7Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20030600009 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Foreign Risperdal Nausea Health (Risperidone) Speech Disorder Professional Solution PS ORAL 1 MG, 1 IN 1 DAY, ORAL Nimodipine () 22-Feb-2006 08:20 AM Page: 1648 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nimodipine C Anhydra Theophylline () Theophylline C Acetylsalicylic Acid (Acetylsalicylic Acid) C Simvastatine (Simvastatin) C Date:06/11/03ISR Number: 4128108-9Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20030600012 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Palsy Foreign Risperdal Health (Risperidone) Professional Tablets PS ORAL 3 MG, ORAL Seroquel (Quetiapine Fumarate) Tablets SS ORAL 100 MG, ORAL Date:06/11/03ISR Number: 4128500-2Report Type:Expedited (15-DaCompany Report #2003SE02600 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Facial Palsy Foreign Seroquel PS Intervention to Health Risperdal SS Prevent Permanent Professional Impairment/Damage Other Date:06/11/03ISR Number: 4164683-6Report Type:Periodic Company Report #2002-07-0777 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Theo-Dur Initial or Prolonged Confusional State Professional (Theophylline) Convulsion Other Extended Release Tablet PS ORAL 200 MG BID ORAL Seroquel (Quetiapine Fumurate) Tablets SS ORAL UNKNOWN ORAL Risperdal SS UNKNOWN Ambien (Zolpidem Tartrate) SS ORAL 10 MG QD ORAL Serevent Inhalation Aerosol 1 Puff Bid Inhalation C Date:06/12/03ISR Number: 4129323-0Report Type:Expedited (15-DaCompany Report #NSADSS2003015708 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Risperdal Head Injury Professional (Risperidone) PS Subdural Haematoma Coumadin (Warfarin Sodium) C 22-Feb-2006 08:20 AM Page: 1649 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/13/03ISR Number: 4128858-4Report Type:Direct Company Report #CTU 195760 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Haloperidol PS 5MG Q 6H Pulse Absent Risperidone 1mg Torsade De Pointes Janssen SS Jassen 1MG BID ONLY GIVEN 1 DOSE Fluconazole 400mg Pfizer SS Pfizer INTRAVENOUS 400MG IV BID Metronidazole 500mg SS ORAL 500MG Q 8H ORAL Albuterol Nebs C Ceftrizidine C Metoprolol C Lansoprazone C Calcium Acetate C Date:06/13/03ISR Number: 4129654-4Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20030600224 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myelofibrosis Foreign Risperdal Health (Risperidone) Professional Unspecified PS Date:06/13/03ISR Number: 4129667-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030600163 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:06/13/03ISR Number: 4129690-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030600072 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukaemia Health Risperdal Professional (Risperidone) Unspecified PS 1 MG Date:06/13/03ISR Number: 4129704-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030600097 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Risperdal Initial or Prolonged Bradycardia Health (Risperidone) Parkinsonism Professional Tablets PS ORAL 1.5 MG, IN 1 DAY, ORAL Date:06/13/03ISR Number: 4129706-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030600297 Age:78 YR Gender:Female I/FU:I Outcome PT Hospitalization - Blood Creatine Initial or Prolonged Phosphokinase Increased 22-Feb-2006 08:20 AM Page: 1650 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depressed Level Of Consciousness General Physical Health Report Source Product Role Manufacturer Route Dose Duration Deterioration Foreign Risperidone Urinary Retention Health (Risperidone) Professional Tablets PS ORAL 4 MG, 1 IN 1 DAY, ORAL Tiapride Hydrochloride (Tablets) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Ethyl Loflazepate (Ethyl Loflazepate) Tablets C Date:06/13/03ISR Number: 4129844-0Report Type:Expedited (15-DaCompany Report #S03-USA-02427-01 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Health Celexa (Citalopram Visual Disturbance Professional Hydrobromide) PS ORAL 10 MG QD PO Company Risperdal Representative (Risperidone) SS Steroids (Nos) C Date:06/16/03ISR Number: 4129176-0Report Type:Expedited (15-DaCompany Report #WAES 0304USA02922 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Zocor PS Merck & Co., Inc ORAL 1057 DAY Hospitalization - Phosphokinase Increased Bezafibrate SS ORAL 1389 DAY Initial or Prolonged Cardio-Respiratory Arrest Zotepine SS 1686 DAY Chest Discomfort Risperidone SS 1686 DAY Dehydration Chlorpromazine Hypokalaemia Hydrochloride SS 1319 DAY Muscle Rigidity Nifedipine C 388 DAY Myocardial Infarction Voglibose C 892 DAY Neuroleptic Malignant Glyburide C 1207 DAY Syndrome Pulmonary Infarction Quadriplegia Rhabdomyolysis Tachycardia Urinary Retention Date:06/16/03ISR Number: 4130337-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030600344 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS 22-Feb-2006 08:20 AM Page: 1651 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/16/03ISR Number: 4130404-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030600298 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Potassium Increased Foreign Risperidone Health (Risperidone) Professional Tablets PS ORAL 2 MG, 1 IN 1 DAY, ORAL Clonazepam (Clonazepam) SS Triazolam (Triazolam) SS Nitrazepam (Nitrazepam) SS Flunitrazepam (Flunitrazepam) SS Warfarin Potassium (Warfarin Potassium) SS Magnesium Oxide (Magnesium Oxide) SS Atorvastatin Calcium (Atorvastatin Calcium) SS Insulin (Insulin) Injection SS Date:06/16/03ISR Number: 4130405-8Report Type:Expedited (15-DaCompany Report #EMADSS2003003240 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Risperdal Initial or Prolonged Cognitive Disorder Health (Risperidone) Coma Professional Tablets PS ORAL 1 MG, ORAL Dyskinesia Ditropan (Oxybutynin Extrapyramidal Disorder Hydrochloride) SS ORAL 5 MG, 3 IN 1 Waxy Flexibility DAY, ORAL Date:06/16/03ISR Number: 4130421-6Report Type:Expedited (15-DaCompany Report #HQWYE474405JUN03 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Avlocardyl Initial or Prolonged Diarrhoea Professional (Propranolol Other Pyrexia Other Hydrochloride, Rash Erythematous Tablet) PS ORAL 40 MG ORAL Rash Macular Allopurinol Rash Pruritic (Allopurinol) SS ORAL 100 MG ORAL 273 DAY Rash Pustular Depakote (Valproate Semisodium) SS ORAL 500MG ORAL Duphaston (Dydrogesterone) SS ORAL ORAL Effexor (Venlafaxine Hydrochloride, Unspec) SS ORAL ORAL Inipomp (Pantoprazole, Unspec) SS Nicobion (Nicotinamide) SS ORAL ORAL Ostram (Calcium 22-Feb-2006 08:20 AM Page: 1652 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphate) SS Risperdal (Risperidone) SS Valium (Diazepam) SS ORAL 10 MG ORAL 28 DAY Date:06/16/03ISR Number: 4130783-XReport Type:Expedited (15-DaCompany Report #USA/00/01128/LEX Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Health Clozaril Hospitalization - Drug Level Increased Professional (Clozapine) PS ORAL SEE IMAGE Initial or Prolonged Overdose Cocaine(Cocaine) SS Valium (Diazepam) SS Alcohol(Ethanol) SS Risperidone (Risperidone) SS Biaxin (Clarithromycin) C Date:06/16/03ISR Number: 4130801-9Report Type:Expedited (15-DaCompany Report #03P-163-0221115-00 Age:42 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Depakene) Health (Valproic Acid) PS Professional Risperidone SS Clonazepam SS Date:06/17/03ISR Number: 4129998-6Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0300803A Age:44 YR Gender:Female I/FU:F Outcome PT Other Abnormal Behaviour Agitation Anxiety Bacteria Urine Identified Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Blood Pressure Increased C-Reactive Protein Increased Confusional State Constipation Dehydration Delusion Disinhibition Excitability Hallucination Hepatic Enzyme Increased Hyperhidrosis Mania Pyelonephritis Pyrexia Reflexes Abnormal Restlessness Serotonin Syndrome White Blood Cell Count 22-Feb-2006 08:20 AM Page: 1653 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Health Paxil PS Glaxosmithkline ORAL 14 DAY Professional Risperidone SS ORAL 4MG per day 3 DAY Sultopride Hydrochloride SS ORAL 800MG per day 2 DAY Etizolam C ORAL 3MG per day 14 DAY Clonazepam C ORAL 1MG per day Promethazine C ORAL 50MG per day 19 DAY Magnesium Oxide C ORAL 1.5G per day Nifedipine C Glaxosmithkline ORAL 40MG per day Clonidine C ORAL 225MCG per day Date:06/17/03ISR Number: 4131259-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030600133 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS Date:06/17/03ISR Number: 4131261-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030600178 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS 0.5 MG, 1 IN 1 DAY Date:06/17/03ISR Number: 4131294-8Report Type:Expedited (15-DaCompany Report #03P-163-0221200-00 Age:69 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Verapamil Sr Multiple Drug Overdose Health (Isoptin Sr) Professional (Verapamil) PS ORAL PER ORAL Metoprolol (Metoprolol) SS ORAL PER ORAL Risperidone SS ORAL PER ORAL Date:06/17/03ISR Number: 4131512-6Report Type:Expedited (15-DaCompany Report #03P-163-0221167-00 Age:72 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Verapamil (Isoptin) Multiple Drug Overdose Health (Verapamil) Professional (Verapamil) PS ORAL PER ORAL Clonazepam SS ORAL PER ORAL Risperidone SS ORAL PER ORAL 22-Feb-2006 08:20 AM Page: 1654 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/03ISR Number: 4131601-6Report Type:Expedited (15-DaCompany Report #2003024145 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Medication Error Health Geodon (Ziprasidone) PS Hospitalization - Pyrexia Professional Clozapine Initial or Prolonged Rhabdomyolysis (Clozapine) SS ORAL 400 MG (BID), Other ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS Risperidone (Risperidone) SS Sertraline Hydrochloride (Sertraline Hydrochloride) C Oxcarbazepine (Oxcarbazepine) C Bisacodyl (Bisacodyl) C Trazodone Hydrochloride (Trazodone Hydrochloride) C Hydroxyzine Embonate (Hydroxyzine Embonate) C Fluphenazine Decanoate (Fluphenazine Decanoate) C Date:06/17/03ISR Number: 4131815-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030600476 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Crackles Lung Foreign Risperidone Initial or Prolonged Dyspnoea Literature (Risperidone) PS Fall Health Amantadine Haemodialysis Professional Hydrochloride Renal Failure Acute (Amatandine Rhabdomyolysis Hydrochloride) C Phenothiazine (Phenothiazine) C Psychotropic Agents (Antipsychotics) C Biperiden (Biperiden) C Flunitrazepam (Flunitrazepam) C Date:06/17/03ISR Number: 4131816-7Report Type:Expedited (15-DaCompany Report #FR-JNFOC-20030600037 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - B-Cell Lymphoma Foreign Risperidone Initial or Prolonged Leukocytosis Health (Risperidone) PS IN 1 DAY Lymphocyte Morphology Professional Leponex (Clozapine) SS Abnormal Valium (Diazepam) C 22-Feb-2006 08:20 AM Page: 1655 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lipanthyl (Fenofibrate) C Parkinane (Trihexyphenidyl Hydrochloride) C Date:06/18/03ISR Number: 4132163-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030600618 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Pressure Foreign Risperdal Immeasurable Health (Risperidone) Loss Of Consciousness Professional Unspecified PS ORAL 6 MG, ORAL Malaise Pallor Pulse Absent Urinary Incontinence Date:06/18/03ISR Number: 4132218-XReport Type:Expedited (15-DaCompany Report #NSADSS2003013316 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disease Progression Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 3 IN 24 HOUR, ORAL Potassium () Potassium C Serzone () Nefazodone Hydrochloride C Lanoxin () Digoxin C Maxzide (Dyazide) C Milk Of Magnesia (Magnesuim Hydroxide) C Multi Vitamin (Multivitamins) C Date:06/18/03ISR Number: 4132224-5Report Type:Expedited (15-DaCompany Report #HQWYE500306JUN03 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Inipomp Initial or Prolonged Diarrhoea Professional (Pantoprazole, Other Pruritus Other Unspec) PS Pyrexia Allopurinol-Ratiopha Rash Macular rm (Allopurinol) SS ORAL 28 DAY Rash Pustular Avlocardyl (Propranolol Hydrochloride, Tablet) SS ORAL 40 MG (FREQUENCY UNSPECIFIED) Depakote (Valproate Semisodium) SS ORAL 500 MG 1X PER 1 DAY Duphaston 22-Feb-2006 08:20 AM Page: 1656 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Dydrogesteron) SS ORAL 10 MG (FREQUENCY UNSPECIFIED) Effexor (Venlafaxine Hydrochloride, Tablet) SS Nicobion (Nicotinamide) SS ORAL 500 MG (FREQUENCY UNSPECIFIED) Ostram (Calcium Phosphate) SS Risperdal (Risperidone) SS ORAL Valium (Diazepam) SS ORAL 10 MG (FREQUENCY UNSPECIFIED) Date:06/18/03ISR Number: 4132417-7Report Type:Expedited (15-DaCompany Report #PHEH2003US04744 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Clozaril (Clozapine) Drug Interaction Professional Tablet PS ORAL SEE IMAGE Company Risperdal Representative (Risperidone) SS Ativan (Lorazepam) SS Date:06/19/03ISR Number: 4133019-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601524 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Literature Risperdal Agitation Health (Risperidone) Cold Sweat Professional Unspecified PS 0.25 - 0.5 Condition Aggravated MG, 1 IN 1 Coordination Abnormal DAY Dizziness Paroxetine Heart Rate Irregular (Paroxetine) SS 20 MG, 1 IN 1 Skin Warm DAY Tremor Isosorbide Dinitrate (Isosorbide Dinitrate) C Lisinopril (Lisinopril) C Glyburide (Glibenclamide) C Venlafaxine (Venlafaxine) C Date:06/19/03ISR Number: 4133047-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601520 Age:86 YR Gender:Male I/FU:I Outcome PT Death Abnormal Behaviour Aggression Agitation Asthenia Cerebral Atrophy 22-Feb-2006 08:20 AM Page: 1657 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Coma Condition Aggravated Confusional State Report Source Product Role Manufacturer Route Dose Duration Dementia Literature Ripserdal Psychotic Disorder Health (Risperidone) Professional Unspecified PS 0.25 MG 1 IN 1 DAY Paroxetine (Paroxetine) SS 10 MG, 1 IN 1 DAY Quinapril (Quinapril) C Simvastatin (Simvastatin) C Date:06/19/03ISR Number: 4133049-7Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20030600610 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Risperdal Hospitalization - Difficulty In Walking Health (Risperidone) Initial or Prolonged Dyskinesia Professional Solution PS 20 DOSE(S) Dysphemia Bromazepam (Drops) C Dystonia Lormetazepam Drops C Incoherent Respiratory Failure Salivary Hypersecretion Date:06/19/03ISR Number: 4133053-9Report Type:Expedited (15-DaCompany Report #EMADSS2003004249 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Foreign Risperdal Initial or Prolonged Positive Health (Risperidone) Rhabdomyolysis Professional Tablets PS ORAL 2 MG, ORAL : 4 MG , ORAL Zyprexa (Olanzapine) SS 15 MG L-Thyroxin (Unspecified) Levothyroxine Sodium C Date:06/19/03ISR Number: 4137827-XReport Type:Periodic Company Report #324425 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Literature Klonopin Increased Health (Clonazepam) PS Aspartate Professional Tylenol Aminotransferase Other (Acetaminophen) SS Increased Tegretol Completed Suicide (Carbamazepine) SS Confusional State Risperdal Somnolence (Risperidone) SS Synthroid (Levothyroxine Sodium) C 22-Feb-2006 08:20 AM Page: 1658 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/03ISR Number: 4132351-2Report Type:Expedited (15-DaCompany Report #WAES 0305USA00828 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Health Pepcid PS Merck & Co., Inc ORAL Professional Risperidone SS ORAL Prednisolone C Bezafibrate C Magnesium Oxide C Date:06/20/03ISR Number: 4132973-9Report Type:Direct Company Report #CTU 196234 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dystonia Risperidone 1mg PS ORAL 1MG BID Required Extrapyramidal Disorder ORAL Intervention to Respiratory Failure Metoclopramide Prevent Permanent 10mg SS ORAL 10MG QID Impairment/Damage ORAL Ondansetron Prn C Chlordiazepoxide Prn C Zolpidem C Date:06/20/03ISR Number: 4133643-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601528 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS 1.5 MG, 1 IN 1 DAY Date:06/20/03ISR Number: 4133647-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601530 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:06/20/03ISR Number: 4133694-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601778 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arterial Disorder Consumer Risperdal Cardiac Arrest (Risperidone) Medication Error Unspecified PS Surgery Date:06/20/03ISR Number: 4133696-2Report Type:Expedited (15-DaCompany Report #NSADSS2002015652 Age:88 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL 0.75 MG, 1 IN 1 DAY 22-Feb-2006 08:20 AM Page: 1659 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoloft (Sertraline Hydrochloride) C Synthroid (Levothyroxine Sodium) C Date:06/20/03ISR Number: 4133725-6Report Type:Expedited (15-DaCompany Report #2003022533 Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Literature Hydroxyzine Aggression Health Hydrochloride Agitation Professional (Tablet) Anxiety (Hydroxyzine Asthenia Hydrochloride) PS Atrophy Risperidone Coma (Risperidone) SS 0.25 MG Confusional State (DAILY) Heart Rate Decreased Paroxetine Hyperhidrosis (Paroxetine) SS 10 MG (DAILY) Hyperpyrexia Quinapril Hypomania (Quinapril) C Hypothermia Simvastatin Lethargy (Simvastatin) C Muscle Rigidity Haloperidol C Myoclonus Physical Assault Psychotic Disorder Respiratory Rate Increased Restlessness Serotonin Syndrome Tachycardia Tachypnoea Trismus Date:06/20/03ISR Number: 4133826-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030601237 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Foreign Risperidone Initial or Prolonged Health (Risperidone) Professional Unspecified PS ORAL ORAL Biperiden Hydrochloride C Levomepromazine Maleate C Date:06/20/03ISR Number: 4133886-9Report Type:Expedited (15-DaCompany Report #HQWYE500306JUN03 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Inipomp Initial or Prolonged Diarrhoea Professional (Pantoprazole, Other Pruritus Other Unspec) PS Pyrexia Allopurinol-Ratiopha Rash Macular rm (Allopurinol) SS ORAL ORAL 28 DAY Rash Pustular Avlocardyl 22-Feb-2006 08:20 AM Page: 1660 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Propranolol Hydrochloride, Tablet) SS ORAL 40 MG ORAL Depakote (Valproate Semisodium) SS ORAL 500 MG 1X PER 1 DAY ORAL Duphaston (Dydrogesterone) SS ORAL 10 MG ORAL Effexor (Venlafaxine Hydrochloride, Tablet) SS Nicobion (Nicotinamide) SS ORAL 500 MG Ostram (Calcium Phosphate) SS Risperdal SS ORAL ORAL Valium (Diazepam) SS ORAL 10 MG ORAL Date:06/23/03ISR Number: 4133033-3Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0293076A Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Paxil PS Glaxosmithkline ORAL Initial or Prolonged Extrapyramidal Disorder Fluvoxamine Maleate SS ORAL Other Hypersensitivity Risperidone SS ORAL Muscle Rigidity Over Counter Cold Speech Disorder Remedy SS ORAL 1 DAY Tongue Disorder Vegetamin A SS ORAL Haloperidol C ORAL 1.5MG per day Lithium Carbonate C Glaxosmithkline ORAL 400MG per day Flunitrazepam C ORAL 2MG per day Biperiden Hydrochloride C ORAL 1MG per day Brotizolam C ORAL .5MG per day 12 DAY Date:06/23/03ISR Number: 4133036-9Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0300803A Age:44 YR Gender:Female I/FU:F Outcome PT Other Abnormal Behaviour Agitation Alanine Aminotransferase Increased Anxiety Aspartate Aminotransferase Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Body Temperature Increased C-Reactive Protein Increased Confusional State Constipation Cystitis Dehydration Delusion 22-Feb-2006 08:20 AM Page: 1661 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disinhibition Excitability Hallucination Report Source Product Role Manufacturer Route Dose Duration Hallucination, Visual Health Paxil PS Glaxosmithkline ORAL 14 DAY Hyperhidrosis Professional Risperidone SS ORAL 4MG per day 3 DAY Insomnia Sultopride Mania Hydrochloride SS ORAL 800MG per day 2 DAY Pyelonephritis Etizolam C ORAL 3MG per day 14 DAY Pyrexia Clonazepam C ORAL 1MG per day Reflexes Abnormal Promethazine C ORAL 50MG per day 19 DAY Restlessness Magnesium Oxide C ORAL 1.5G per day Serotonin Syndrome Nifedipine C Glaxosmithkline ORAL 40MG per day White Blood Cell Count Clonidine C ORAL 225MCG per Increased day Date:06/23/03ISR Number: 4134528-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601535 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Consumer Risperdal Initial or Prolonged Aggression (Risperidone) Condition Aggravated Solution PS 0.5 MG, 2 IN Constipation 1 DAY Dyskinesia Paxil () Paroxetine Infectious Mononucleosis Hydrochloride C Migraine Adderall () Obetrol C Obsessive-Compulsive Disorder Date:06/23/03ISR Number: 4134841-5Report Type:Expedited (15-DaCompany Report #FRWYE134316MAY03 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Generalised Health Effexor (Venlafaxine Initial or Prolonged Exanthematous Pustulosis Professional Hydrochloride, Other Alanine Aminotransferase Other Tablet, 0) PS ORAL 50 MG 6X PER Increased 1 DAY 7 YR Aspartate Allopurinol-Ratiopha Aminotransferase rm (Allopurinol, 0) SS ORAL 273 DAY Increased Avlocardyl Asthenia (Propranolol Diarrhoea Hydrochloride, Eosinophil Count Tablet, 0) SS ORAL Increased Depakote (Valproate Gamma-Glutamyltransferase Semisodium, 0) SS ORAL 500 MG 3X PER Increased 1 DAY 40 DAY Pruritus Duphaston Pyrexia (Dydrogesterone, 0) SS ORAL Uveitis Inipomp (Pantoprazole , Unspec, 0) SS Nicobion (Nicotinamide, 0) SS ORAL Ostram (Calcium Phosphate, , 0) SS Risperdal (Risperidone, 0) SS ORAL 2 MG 1X PER 1 DAY 40 DAY Valium (Diazepam, 0) SS ORAL 28 DAY 22-Feb-2006 08:20 AM Page: 1662 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/03ISR Number: 4134708-2Report Type:Direct Company Report #CTU 196527 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Risperdal PS ORAL 1 EVENING Initial or Prolonged Headache ORAL Disability Date:06/24/03ISR Number: 4135490-5Report Type:Expedited (15-DaCompany Report #HQWYE474405JUN03 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Avlocardyl Initial or Prolonged Diarrhoea Professional (Propranolol Other Pyrexia Other Hydrochloride, Rash Erythematous Tablet) PS ORAL 40 MG Rash Macular Allopurinol Rash Pruritic (Allopurinol, ) SS ORAL 100 MG 273 DAY Rash Pustular Depakote (Valproate Semisodium, ) SS ORAL 500MG Duphaston (Dydrogesterone, ) SS ORAL Effexor (Venlafaxine Hydrochloride, Unspec) SS ORAL Inipomp (Pantoprazole, Unspec) SS Nicobion (Nicotinamide, ) SS ORAL Ostram (Calcium Phosphate, ) SS Risperdal (Risperidone, ) SS Valium (Diazepam, ) SS ORAL 10MG 28 DAY Date:06/24/03ISR Number: 4137694-4Report Type:Periodic Company Report #NSADSS2002037002 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Haldol (Unspecified) Initial or Prolonged Extrapyramidal Disorder (Haloperidol) PS Headache Risperdal (1 Mg Insomnia Tablet) Pain (Risperidone) SS ORAL 1 MG, 1 IN DAILY, ORAL Seroquel (Seroquel) C Date:06/25/03ISR Number: 4135592-3Report Type:Direct Company Report #CTU 196630 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Intolerance Risperdal Tablet PS Furosemide C Divalproex C A&D Oint C Fosinopril C Milk Of Magnesia C Bisacodyl C 22-Feb-2006 08:20 AM Page: 1663 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acetaminophen C Trazodone C Ranitidine C Aspirin C Levothyroxin Sodium C Cefazolin C Date:06/25/03ISR Number: 4136135-0Report Type:Expedited (15-DaCompany Report #HQWYE500306JUN03 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Health Inipomp Initial or Prolonged Diarrhoea Professional (Pantoprazole, Other Pruritus Other Unspec) PS Pyrexia Allopurinol-Ratiopha Rash Macular rm (Allopurinol, SS ORAL 28 DAY Rash Pustular Avlocardyl (Propranolol Hydrochloride, Tablet) SS ORAL 40 MG (FREQUENCY UNSPECIFIED) Depakote (Valproate Semisodium, ) SS ORAL 500 MG 1 X PER 1 DAY Duphaston (Dydrogesterone, ) SS ORAL 10 MG (FREQUENCY UNSPECIFIED) Effexor (Venlafaxine Hydrochloride, Tablet) SS ORAL Nicobion (Nicotinamide) SS ORAL 500 MG (FREQUENCY UNSPECIFIED) Ostram (Calcium Phosphate) SS Risperdal (Risperidone) SS Valium (Diazepam) SS ORAL 10 MG (FREQUENCY UNSPECIFIED) Date:06/26/03ISR Number: 4137023-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030601236 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperidone Tablets PS 50-100 MG Initial or Prolonged Phosphokinase Increased Health DAILY Multiple Drug Overdose Professional Neuroleptic Malignant Syndrome 22-Feb-2006 08:20 AM Page: 1664 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/03ISR Number: 4137090-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030601235 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Risperidone Blood Lactate Health (Risperidone) Dehydrogenase Professional Tablets PS ORAL 8 MG, 1 IN 1 Hepatocellular Damage DAY, ORAL Pyrexia Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL 300 MG, 1 IN 1 DAY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Vegetamin A (Vegetamin A) C Sennoside (All Other Therapeutic Products) C Flunitrazepam (Plunitrazepam) C Haloperidol (Haloperidol) C Chlorpromazine Hydrochloride (Chlorpromazine Hyderochloride) C Date:06/26/03ISR Number: 4137092-3Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20030600224 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myelofibrosis Foreign Risperdal Health (Risperidone) Professional Unspecified PS Date:06/26/03ISR Number: 4137148-5Report Type:Expedited (15-DaCompany Report #EMADSS2003001016 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Risperidone) PS 2 MG, 1 IN 1 Professional DAY Leponex (Clozapine)Tablets SS ORAL 2.5 MG, 2 IN 1 DAY, ORAL Quilonum (Tablets) Lithium Acetate C Melperone (Melperone) C Pipamperone (Pipamperone) Tablets C Zopiclon (Zopiclone) Tablets C 22-Feb-2006 08:20 AM Page: 1665 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/03ISR Number: 4137154-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030601554 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperidone Health (Risperidone) Professional Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Date:06/26/03ISR Number: 4137164-3Report Type:Expedited (15-DaCompany Report #EMADSS2003004471 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Risperdal Initial or Prolonged Condition Aggravated Health (Risperidone) Disability Disturbance In Attention Professional Tablets PS ORAL 4 MG, 2 IN 1 Hallucination DAY, ORAL Panic Attack Trazadone Psychotic Disorder (Trazadone) C Thinking Abnormal White Blood Cell Count Increased Date:06/26/03ISR Number: 4137441-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030602296 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS 0.5 MG, 1 IN 1 DAY Date:06/26/03ISR Number: 4137448-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601832 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS Date:06/26/03ISR Number: 4137458-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601525 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Health Risperdal Neutrophil Count Professional (Risperidone) Decreased Tablets PS Platelet Count Decreased Valproic Acid () White Blood Cell Count Valproic Acid C Date:06/26/03ISR Number: 4137465-9Report Type:Expedited (15-DaCompany Report #NSADSS2002020396 Age:103 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Failure Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1666 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/26/03ISR Number: 4137474-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601830 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Health Risperdal Increased Professional (Risperidone) Blood Prolactin Increased Tablets PS 0.5 MG, 2 IN Blood Urea Increased 1 DAY White Blood Cell Count Decreased Date:06/26/03ISR Number: 4137515-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601813 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Study Risperidone Initial or Prolonged Aspartate Health (Risperidone) Aminotransferase Professional Unspecified PS Blood Alkaline Perphenazine Phosphatase (Perphenazine) SS Blood Bicarbonate Olanzapine Blood Calcium (Olanzapine) SS Blood Chloride Quetiapine Blood Creatine (Quetiapine) SS Phosphokinase Ziprasidone Blood Creatine (Ziprasidone) SS Phosphokinase Mb Clonazepam () Blood Creatinine Clonazepam C Blood Glucose Mirtazapine () Blood Magnesium Mirtazapine C Blood Ph Increased Catopril () Blood Potassium Captopril C Blood Sodium Glipizide () Dyspnoea Glipizide C Electrocardiogram T Wave Abnormal Glucose Urine Present Haemoglobin Mental Disorder Oxygen Saturation Decreased Pco2 Po2 Protein Total Pulmonary Congestion Pulmonary Vascular Disorder Red Blood Cells Urine Positive Sinus Tachycardia Thirst Urine Ketone Body Present White Blood Cells Urine Positive 22-Feb-2006 08:20 AM Page: 1667 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/03ISR Number: 4138609-5Report Type:Expedited (15-DaCompany Report #APCDSS2003000504 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Risperidone Hospitalization - Blood Creatine Health (Risperidone) Initial or Prolonged Phosphokinase Increased Professional Tablets PS ORAL 2 MG, 1 IN 1 Required Cardio-Respiratory Arrest DAY, ORAL Intervention to Electrolyte Imbalance Etizolam (Etizolam) Prevent Permanent Hypotension Tablets SS ORAL 0.5 MG, 1 IN Impairment/Damage Insomnia 1 DAY, ORAL Loss Of Consciousness Nitrazepam Multi-Organ Failure (Nitrazepam) Tablets SS ORAL 1 DOSE(S), Mydriasis ORAL Treatment Noncompliance Date:06/27/03ISR Number: 4138622-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030602437 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Risperidone Ventricular Fibrillation Health (Risperidone) PS ORAL 12 MG, 1 IN 1 Professional DAY, ORAL Dimeticone (Tablets) Dimeticone C Cetilo (Tablets) All Other Therapeutic Products C Amezinium Metisulfate (Amezinium Metilsulfate) Tablets C Vegetamin-A (Vegetamin A) Tablets C Brotizolam (Brotizolam) Tablets C Olanzapine (Olanzapine) C Date:06/27/03ISR Number: 4138694-0Report Type:Expedited (15-DaCompany Report #FRWYE111929APR03 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Biliary Cyst Foreign Seresta (Oxazepam, Initial or Prolonged Confusional State Health Tablet, 0) PS ORAL ORAL 39 DAY Eosinophil Count Professional Athymil (Mianserin Increased Other Hydrochloride, ,0) SS ORAL ORAL 39 DAY Hepatic Lesion Augmentin Oral Hepatitis Cholestatic (Amoxicillin Neutrophil Count Trihydrate/Clavulana Decreased te Potassium, ,0) SS ORAL 1 DOSE 3X PER Prothrombin Time Ratio 1 DAY ORAL 24 DAY Decreased Ciflox (Ciprofloxacin, ,0) SS ORAL 500 MG 2X PER 1 DAY ORAL 24 DAY Risperdal (Risperidone, ,0) SS ORAL 1 MG 2X PER 1 DAY ORAL 8 DAY 22-Feb-2006 08:20 AM Page: 1668 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tiapridal (Tiapride, ,0) SS ORAL ORAL 43 DAY Imovane (Zopiclone) C Tranxene (Clorazepate Dipotassium) C Date:06/27/03ISR Number: 4139073-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030602269 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Consumer Risperdal White Blood Cell Count (Risperidone) PS 0.125 MG, 2 Decreased IN 1 DAY Depakote (Valproate Semisodium) C Strattera (Cetiedil) C Date:06/30/03ISR Number: 4138298-XReport Type:Direct Company Report # Age:86.5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Medication Error Risperdal PS 3 - 24 HRS Disability Alprazolam SS Other Digoxin SS Date:06/30/03ISR Number: 4139395-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030602893 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS 1 MG, 2 IN 1 DAY Date:06/30/03ISR Number: 4139398-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030603234 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS Date:06/30/03ISR Number: 4139467-5Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anorexia Initial or Prolonged Blood Creatine Phosphokinase Increased Blood Pressure Increased Condition Aggravated Delusion Diabetes Mellitus Hallucination Hypoventilation Insomnia 22-Feb-2006 08:20 AM Page: 1669 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Distress Schizophrenia Report Source Product Role Manufacturer Route Dose Duration Foreign Haldol (Haloperidol Health Decanoate) Professional Unspecified PS ORAL 10.5 MG, 1 IN 1 DAY, ORAL Risperdal (Risperidone) Tablets SS ORAL SEE IMAGE Quetiapine Fumarate (Quetiapine Fumarate) Tablets SS ORAL 600 MG, 1 IN 1 DAY, ORAL Hydroxyzine Pamoate (Hydroxyzine Embonate) C Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:06/30/03ISR Number: 4139475-4Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Haldol (Haloperidol Initial or Prolonged Blood Creatine Health Decanoate) PS ORAL 10.5 MG, 1 IN Phosphokinase Increased Professional 1 DAY, ORAL Blood Pressure Increased Risperidal Condition Aggravated (Risperidone) Delusion Tablets SS ORAL SEE IMAGE, Diabetes Mellitus ORAL Hallucination Quetiapine Fumarate Hypoventilation (Quetiapine Insomnia Fumarate) Tablets SS ORAL 600 MG, 1 IN Oxygen Saturation 1 DAY, ORAL Decreased Hydroxyzine Pamoate Respiratory Distress (Hydroxyzine Schizophrenia Embonate) C Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:06/30/03ISR Number: 4139491-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030601554 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Other Leukopenia Foreign Health 22-Feb-2006 08:20 AM Page: 1670 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperidone (Risperidone) Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Date:06/30/03ISR Number: 4139492-4Report Type:Expedited (15-DaCompany Report #EMADSS2003003388 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Neutropenia Health (Risperidone) Professional Tablets PS ORAL 4 MG, 1 IN 1 DAY, ORAL Lysanxia (Praxepam) C Prozac (Fluoxetine Hydrochloride) C Depamide (Valpromide) C Date:06/30/03ISR Number: 4139493-6Report Type:Expedited (15-DaCompany Report #EMADSS2003003434 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Device Failure Foreign Risperdal Laboratory Test Health (Risperidone) Interference Professional Unspecified PS ORAL SEE IMAGE Methotrexate (Methotrexate) C Prozac (Fluoxetine Hydrochloride) C Corticoids (Corticoids) C Date:06/30/03ISR Number: 4139494-8Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20030602178 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Oedema Foreign Risperidone Convulsion Health (Risperidone) Drug Interaction Professional Tablets PS ORAL 0.5 MG, ORAL Hyponatraemia Efexor (Venlafaxine Hydrochloride) SS 75 MG Tegretol (Carbamazepine) SS 200 MG Alvedon (Paracetamol) C Movicol (Nulytely) C Propavan (Propiomazine Maleate) C Stesolid (Diazepam) C Natriumklorid (Electrolyte Solutions) C Xanor (Alprazolam) C 22-Feb-2006 08:20 AM Page: 1671 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/03ISR Number: 4139495-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030602183 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Neutropenia Health (Risperidone) Tablet PS 2 MG, 1 IN 1 Professional DAY Date:06/30/03ISR Number: 4139497-3Report Type:Expedited (15-DaCompany Report #APCDSS2003000614 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Compartment Syndrome Foreign Risperdal Hospitalization - Hyperreflexia Health (Risperidone) Initial or Prolonged Hyporeflexia Professional Unspecified PS 4 MG, 1 IN 1 Neuroleptic Malignant DAY; 120 MG Syndrome Haloperidol Overdose (Haloperidol) Rash Maculo-Papular Unspecified SS 6 MG, 1 IN 1 Rhabdomyolysis DAY; 45 MG Skin Graft Vasculitic Rash Date:06/30/03ISR Number: 4139556-5Report Type:Expedited (15-DaCompany Report #APCDSS2003000614 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatinine Foreign Risperdal Hospitalization - Compartment Syndrome Health (Risperidone) Initial or Prolonged Hyperreflexia Professional Unspecified PS SEE IMAGE Hyporeflexia Haloperidol Muscle Spasms (Haloperidol) Neuroleptic Malignant Unspecified SS SEE IMAGE Syndrome Overdose Rash Maculo-Papular Rhabdomyolysis Skin Graft Vasculitic Rash Date:06/30/03ISR Number: 4139886-7Report Type:Expedited (15-DaCompany Report #NSADSS2003018595 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL Date:06/30/03ISR Number: 4148624-3Report Type:Periodic Company Report #2002066314 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Consumer Zoloft (Sertraline) PS ORAL 20 MG Anxiety (DAILY), ORAL Delusion Oxcarbazepine Insomnia (Oxcarbazepine) SS Stress Incontinence Risperidone Tremor (Risperidone) SS 22-Feb-2006 08:20 AM Page: 1672 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Omeprazole (Omeprazole) C Buspirone Hydrochloride (Busiprone Hydrochloride) C Valproate Semisodium (Valproate Semisodium) C Date:07/01/03ISR Number: 4138247-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12304044 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Fluphenazine Hcl PS Apothecon INTRAMUSCULAR Dosage: "25 Initial or Prolonged Somnolence kg" Urinary Tract Infection Risperidone SS ORAL 1MG in a.m. & 2MG in p.m. Lorazepam SS ORAL 1MG nocte Date:07/01/03ISR Number: 4140024-5Report Type:Direct Company Report #CTU 197022 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Increased Risperidone PS RISPERIDONE Hospitalization - Cardiac Arrest 0.5 BID Initial or Prolonged Chills Quetiapine SS QUETIAPINE 25 Decreased Activity MG QHS Dyspnoea Lexapro C Haematemesis Quinine Sulfate C Hallucinations, Mixed Neuroleptic Malignant Syndrome Pneumonia Aspiration Tachypnoea Date:07/02/03ISR Number: 4141184-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030603414 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Marrow Disorder Foreign Risperdal Platelet Count Decreased Health (Risperidone) Professional Unspecified PS 1 MG Date:07/02/03ISR Number: 4141199-4Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20030602568 Age:33 YR Gender:Female I/FU:I Outcome PT Death Cardiac Arrest Circulatory Collapse Cyanosis Dysphagia Extrapyramidal Disorder Fall Heart Rate Irregular Hypotension Loss Of Consciousness 22-Feb-2006 08:20 AM Page: 1673 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Musculoskeletal Stiffness Mutism Pulse Absent Report Source Product Role Manufacturer Route Dose Duration Salivary Hypersecretion Foreign Rispderdal Vertigo Health (Risperdal) Tablets PS ORAL 2 MG, ORAL; 4 Professional MG, ORAL; 6 MG, ORAL; 2 MG, ORAL Losec () Omeprazole C Cipramil (Tablets) Citalopram Hydrobromide C Akineton (Biperiden Hydrochloride) C Date:07/02/03ISR Number: 4141200-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030602919 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Risperdal Initial or Prolonged Multiple Drug Overdose Health (Risperidone) Sedation Professional Unspecified PS 84 MG, Vomiting Clozapine (Clozapine) Unspecified SS ORAL 9100 MG, ORAL Date:07/02/03ISR Number: 4141201-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030602974 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Risperdal Increased Health (Risperidone) Aspartate Professional Unspecified PS 2 MG, 2 IN 1 Aminotransferase DAY, Increased Gamma-Glutamyltransferase Increased Leukaemia Leukocytosis Date:07/02/03ISR Number: 4141279-3Report Type:Expedited (15-DaCompany Report #EMADSS2003004284 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperdal Initial or Prolonged Hepato-Lenticular Health (Risperidone) PS ORAL 4 MG, ORAL Other Degeneration Professional Lyogen (Injection) Liver Function Test Fluphenazine C Abnormal Cipramil Psychotic Disorder (Unspecified) Treatment Noncompliance Citalopram Ultrasound Liver Abnormal Hydrobromide C 22-Feb-2006 08:20 AM Page: 1674 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/03ISR Number: 4141280-XReport Type:Expedited (15-DaCompany Report #APCDSS2003000728 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Headache Foreign Risperidone Hypomania Health (Risperidone) Insomnia Professional Tablets PS ORAL SEE IMAGE Irritability Bromocriptine Mood Altered (Bromocriptine) SS Pituitary Tumour Benign Clonazepam (Tablets) Weight Increased Clonazepam C Ventolin (Salbutamol) C Seretide (Seretide) C Birth Control Pills (Oral Contraceptive Nos) C Date:07/02/03ISR Number: 4141281-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030603544 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Risperdal Initial or Prolonged Sedation Health (Risperidone) PS ORAL SEE IMAGE Urinary Tract Infection Professional Lorazepam (Lorazepam) SS ORAL 1 MG, ORAL Fluphenazine (Fluphenazine) SS INTRAMUSCULAR 25 MG, INTRAMUSCULAR Date:07/02/03ISR Number: 4141282-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030603422 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholinesterase Foreign Risperdal Decreased Health (Risperidone) PS ORAL SEE IMAGE Professional Dipiperon (Pipamperone) C Calcium (Calcium) C Date:07/02/03ISR Number: 4141527-XReport Type:Expedited (15-DaCompany Report #NSADSS2003010108 Age:94 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.25 MG, 2 IN 1 DAY, ORAL Date:07/02/03ISR Number: 4141564-5Report Type:Expedited (15-DaCompany Report #FRWYE134316MAY03 Age:56 YR Gender:Female I/FU:F Outcome PT Hospitalization - Acute Generalised Initial or Prolonged Exanthematous Pustulosis Other Alanine Aminotransferase Increased Aspartate 22-Feb-2006 08:20 AM Page: 1675 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Diarrhoea Gamma-Glutamyltransferase Report Source Product Role Manufacturer Route Dose Duration Increased Health Effexor (Venlafaxine Uveitis Professional Hydrochloride, Other Tablet, 0) PS ORAL 50 MG 6 X PER 1 DAY Allopurinol-Ratiopha rm (Allopurinol, , 0) SS ORAL 273 DAY Avlocardyl (Propranolol Hydrochloride, Tablet, 0) SS ORAL Depakote (Valproate Semisodium, , 0) SS ORAL 500 MG 3 X PER 1 DAY 40 DAY Duphaston (Dydrogesterone, , 0) SS ORAL Inipomp (Pantoprazole, Unspec, 0) SS Nicobion (Nicotinamide, , 0) SS ORAL Ostram (Calcium Phosphate, , 0) SS Risperdal (Risperidone, , 0) SS ORAL Valium (Diazepam) SS ORAL Date:07/02/03ISR Number: 4141669-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030603239 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:07/02/03ISR Number: 4141670-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030604132 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:07/02/03ISR Number: 4141671-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030604176 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS 22-Feb-2006 08:20 AM Page: 1676 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/03ISR Number: 4141672-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030604428 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Risperdal Professional (Risperidone) Company Tablets PS ORAL 1 MG, 2 IN 1 Representative DAY, ORAL Xanax () Alprazolam C Lexapro () All Other Therapeutic Products C Date:07/02/03ISR Number: 4146911-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030602437 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperidone Hospitalization - Cerebral Atrophy Health (Risperidone) Initial or Prolonged Circulatory Collapse Professional Tablets PS ORAL ORAL Drug Abuser Olanzapine Feeling Abnormal (Olanzapine) Tablets SS ORAL ORAL Gait Disturbance Amezinium Hallucination, Auditory Metisulfate Ventricular Fibrillation (Amezinium Metilsulfate) Tablets SS ORAL 20 MG, 1 IN 1 DAY, ORAL Dimeticone (Tablets) Dimeticone C Cetilo (Tablets) All Other Therapeutic Products C Vegetamin-A (Vegetamin A) Tablets C Brotizolam (Brotizolam) Tablets C Itropride Hydrochloride (Itopride Hydrochloride) C Sennoside (All Other Therapeutic Products) Tablets C Haloperidol (Haloperidol) Tablets C Senna Extract (Senna Liquid Extract) Tablets C Date:07/02/03ISR Number: 4175580-4Report Type:Periodic Company Report #EMADSS2003002426 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Durogesic (Ptach) Initial or Prolonged Hypertonia Health (Fentanyl) PS TRANSDERMAL TRANSD Pyrexia Professional Risperdal (Unspecified) (Riseridone) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1677 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seropram (Citalopram Hydrobromide) SS ORAL ORAL Lenital (Glyceryl Trinitrate) C Vastarel (Trimetazidine Dihydrochloride) C Imovane (Zopiclone) C Date:07/02/03ISR Number: 4181729-XReport Type:Periodic Company Report #EMADSS2002006366 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Risperdal Initial or Prolonged Health (Unspecified) Professional (Risperidone) PS ORAL 5 MG, DAILY, ORAL Durogesic (25 Mcg/Hr Patch) (Fentanyl) SS TRANSDERMAL 25 MCG/H, 1 IN 3 DAYS, TRANSD Date:07/03/03ISR Number: 4142080-7Report Type:Expedited (15-DaCompany Report #APCDSS2002001459 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Risperdal Initial or Prolonged Amnesia Health (Risperidone) Anorexia Professional Tablets PS ORAL 3 MG, 1 IN 1 Anxiety DAY, ORAL Blood Calcium Decreased Biperiden Blood Cholesterol Hydrochloride Increased (Tablets) Biperiden Blood Creatine Hydrochloride C Phosphokinase Increased Nitrazepam Blood Ketone Body Present (Nitrazepam) Tablets C Blood Potassium Decreased Sennodside (All Blood Prolactin Increased Other Therapeutic Condition Aggravated Products) Tablets C Constipation Lansoprazole Delusional Disorder, (Lansoprazole) Erotomanic Type Tablets C Depression Mosapride Citrate Gastritis Atrophic (Mosapride Citrate) Irritability Tablets C Medication Error Domperidone Monocytosis (Domperidone) Nasopharyngitis Tablets C Nausea Oral Intake Reduced Overdose Stress Thought Broadcasting Vomiting Weight Decreased 22-Feb-2006 08:20 AM Page: 1678 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/03/03ISR Number: 4142088-1Report Type:Expedited (15-DaCompany Report #EMADSS2003004238 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Antidiuretic Foreign Risperdal Hormone Decreased Health (Risperidone) Cardiac Failure Professional Unspecified PS ORAL 3 MG, ORAL Cyanosis Akineton Nocturia (Unspecified) Polydipsia Biperiden Polyuria Hydrochloride C Date:07/03/03ISR Number: 4142720-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030604425 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Ris[Perdal Professional (Risperidone) Tablets PS ORAL 3 MG, 1 IN 1 DAY, ORAL Date:07/08/03ISR Number: 4145007-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030604066 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnestic Disorder Foreign Haldol-Janssen Initial or Prolonged Cognitive Deterioration Health (Haloperidol) Drug Interaction Professional Unspecified PS ORAL 5 MG, 1 IN 1 Hallucination, Auditory DAY, ORAL Hallucination, Visual Risperdal Psychomotor Retardation (Risperidone) Somnolence Unspecified SS ORAL 4 MG, 1 IN 1 Sopor DAY, ORAL Eunerpan (Melperone Hydrochloride) SS ORAL 25 MG, 1 IN 1 DAY, ORAL Lasix (Furosemide) C Date:07/08/03ISR Number: 4145009-0Report Type:Expedited (15-DaCompany Report #EMADSS2003000484 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Risperdal Initial or Prolonged Overdose Study (Risperidone) Required Health Tablets PS ORAL SEE IMAGE Intervention to Professional Haldol (Haloperidol) Prevent Permanent Unspecified SS SEE IMAGE Impairment/Damage Akineton (Biperiden Hydrochloride) Tablets SS ORAL SEE IMAGE Tavor (Lorazepam) Unspecified SS 10 MG, 1 IN 1 AS NECESSARY 22-Feb-2006 08:20 AM Page: 1679 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/03ISR Number: 4145057-0Report Type:Expedited (15-DaCompany Report #DSA_22950_2003 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Ativan PS ORAL 1 MG QHS PO Initial or Prolonged Depressed Level Of Other Risperidone SS ORAL VAR BID PO Consciousness Fluphenazine SS INTRAMUSCULAR 25 MG IM Somnolence Urinary Tract Infection Date:07/08/03ISR Number: 4145131-9Report Type:Expedited (15-DaCompany Report #PHRM2003FR01788 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Melleril Initial or Prolonged Depressed Level Of Health (Thioridazine Consciousness Professional Hydrochloride) Fall Other Solution PS ORAL 35 DROPS PER Haemodialysis DAY, ORAL Hyperkalaemia Risperdal Hypotension (Risperidone) Soft Hypothermia Gelatin Capsule SS ORAL 35 DROPS IN Malaise THE EVENING, Parkinson'S Disease ORAL Pupils Unequal Risperdal Renal Failure Acute (Risperidone) Rhabdomyolysis Tablet, 1mg SS ORAL 1 MG DAILY, ORAL Lopril C Date:07/08/03ISR Number: 4145143-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030604068 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Risperdal Initial or Prolonged Eye Rolling Health (Risperidone) Faecal Incontinence Professional Tablets PS ORAL 1.5 MG, ORAL Gait Disturbance Topalgic (Tramadol Humerus Fracture Hydrochloride) SS ORAL SEE IMAGE Loss Of Consciousness Atarax (Hydroxyzine Malaise Hydrochloride) Salivary Hypersecretion Tablets SS ORAL SEE IMAGE Syncope Imovane (Zopiclone) Tongue Biting Tablets SS ORAL 7.5 MG, ORAL Urinary Incontinence Cacit Vitamine D3 (Cacit) SS I SACHET Zoloft (Sertraline Hydrochloride) SS ORAL ORAL Date:07/08/03ISR Number: 4145145-9Report Type:Expedited (15-DaCompany Report #EMADSS2003000484 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Risperdal Initial or Prolonged Intentional Overdose Study (Risperidone) Required Health Tablets PS ORAL SEE IMAGE Intervention to Professional Haldol (Haloperidol) Prevent Permanent Unspecified SS 8 MG, 1 IN 1 Impairment/Damage DAY; 20 DOSE 22-Feb-2006 08:20 AM Page: 1680 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (S), 1 IN 1 AS NECESSARY; 8 MG, 1 IN 1 Akineton (Biperiden Hydrochloride) Tablets SS ORAL 4 MG, 1 IN 1 DAY, ORAL; 80 DOSE (S), 1 IN 1 AS NECESSARY, Tavor (Lorazepam) Unspecified SS 10 MG, 1 IN 1 AS NECESSARY Date:07/08/03ISR Number: 4145202-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030604068 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Risperdal Initial or Prolonged Drug Interaction Health (Risperidone) Gait Disturbance Professional Tablets PS ORAL 1.5 MG, ORAL Humerus Fracture Topalgic (Tramadol Syncope Hydrochloride) Capsules SS ORAL SEE IMAGE Atarax(Hydroxyzine Hydrochloride0 SS ORAL SEE IMAGE Imovane (Zopiclone) Tablets SS ORAL 7.5 MG, ORAL Cacit Vitamine D3 (Cacit) Unknown SS I SACHET Zoloft (Sertraline Hydrochloride)Capsul es SS ORAL ORAL Date:07/08/03ISR Number: 4145207-6Report Type:Expedited (15-DaCompany Report #GB-20030604172 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polycystic Ovaries Foreign Risperdal Health (Risperidone) Professional Unspecified PS Date:07/08/03ISR Number: 4145209-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030700015 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antibody Test Positive Foreign Risperdal Meningioma Health (Risperidone) Professional Unspecified PS ORAL 2 MG, 1 IN 1 DAY, ORAL Date:07/08/03ISR Number: 4145211-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030701064 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diplegia Foreign Risperidone Consumer (Risperidone) Unspecified PS ORAL 48 MG, 1 IN 1 22-Feb-2006 08:20 AM Page: 1681 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY, ORAL Date:07/08/03ISR Number: 4145213-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030700888 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amenorrhoea Foreign Risperdal Initial or Prolonged Pituitary Tumour Benign Health (Risperidone) Professional Tablets PS ORAL SEE IMAGE Vioxx (Rofecosib) C Xanax (Alpralzolam) C Dialgirex (Aporex) C Date:07/08/03ISR Number: 4145214-3Report Type:Expedited (15-DaCompany Report #EMADSS2003003727 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal Mental Disorder Health (Risperidone) Neutrophil Count Professional Unspecified PS ORAL 8 MG, ORAL Decreased Risperdal Platelet Count Decreased (Risperidone) White Blood Cell Count Unspecified SS Decreased Convulex (Valproate Sodium) Unspecified SS SEE IMAGE Remeron (Mirtazapine) Unspecified SS 30 MG Atarax(Hydroxyzine Hydrochloride) C Co Reniten (Vaseretic) Unspecified C Entumin (Clotiapine) Unspecified C Tramal (Tramadol Hydrochloride) Unspecified C Date:07/08/03ISR Number: 4145507-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601813 Age:36 YR Gender:Female I/FU:F Outcome PT Hospitalization - Acute Respiratory Initial or Prolonged Distress Syndrome Alanine Aminotransferase Aspartate Aminotransferase Blood Alkaline Phosphatase Blood Bicarbonate Blood Calcium Blood Chloride Blood Creatine Blood Creatine Phosphokinase Blood Creatine Phosphokinase Mb Blood Glucose 22-Feb-2006 08:20 AM Page: 1682 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Magnesium Blood Urine Chest X-Ray Abnormal Report Source Product Role Manufacturer Route Dose Duration Dyspnoea Study Risperidone Electrocardiogram T Wave Health (Risperidone) Abnormal Professional Unspecified PS Glucose Urine Present Perphenazine Haematocrit Decreased (Perphenazine) SS Haemoglobin Olanzapine Hypokalaemia (Olanzapine) SS Hyponatraemia Quetiapine Mental Disorder (Quetiapine) SS Pco2 Decreased Ziprasidone Po2 Decreased (Ziprasidone) SS Polydipsia Psychogenic Clonazepam C Protein Total Mirtazapine C Pulmonary Congestion Catopril C Respiratory Failure Glipizide C Sinus Tachycardia Thirst Troponin White Blood Cells Urine Positive Date:07/08/03ISR Number: 4145509-3Report Type:Expedited (15-DaCompany Report #NSADSS2003015686 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Consumer Risperdal Paranoia Health (Risperidone) Professional Unspecified PS ORAL ORAL Effexor ()Venlafaxine Hydrochloride C .. C Trazodone C Date:07/09/03ISR Number: 4144424-9Report Type:Direct Company Report #CTU 197515 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphonia Risperdal PS 1 PILL 0.5 MG Required Difficulty In Walking Intervention to Epistaxis Prevent Permanent Mental Impairment Impairment/Damage Petit Mal Epilepsy Retinal Disorder Visual Disturbance Date:07/09/03ISR Number: 4146527-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030700578 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Consumer Risperdal Hospitalization - Fall (Risperidone) Initial or Prolonged Hip Fracture Unspecified PS 22-Feb-2006 08:20 AM Page: 1683 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/03ISR Number: 4146529-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030700562 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Health Risperdal Myocardial Infarction Professional (Risperidone) Tablets PS ORAL 2 MG, 2 IN 1 DAY, ORAL Potassium (Potassium) C Aspirin (Acetylsalicylic Acid) C Nitro-Bid (Glyceryl Trinitrate) C Lorazepam (Lorazepam) C Lasix (Furosemide) C Isosorbide (Isosorbide) C Date:07/09/03ISR Number: 4147381-4Report Type:Expedited (15-DaCompany Report #EMADSS2003004249 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autoimmune Disorder Foreign Risperdal Initial or Prolonged Polymyositis Health (Risperidone) Rhabdomyolysis Professional Tablets PS ORAL 2 MG, ORAL Zyprexa (Olanzapine) Unspecified SS 15 MG L-Thyroxin (Levothyroxine Sodium) C Date:07/10/03ISR Number: 4144535-8Report Type:Expedited (15-DaCompany Report #RO-GLAXOSMITHKLINE-B0303756A Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Atrophy Health Paroxetine PS Glaxosmithkline ORAL 10MG Per day 8 DAY Hospitalization - Completed Suicide Professional Carbamazepine SS ORAL 200MG Twice Initial or Prolonged Confusional State per day 8 DAY Delirium Imovane SS ORAL 7.5MG Per day 8 DAY Injury Asphyxiation Rispolept SS ORAL 3MG Twice per day 8 DAY Date:07/10/03ISR Number: 4144629-7Report Type:Direct Company Report #CTU 197617 Age:49 YR Gender:Male I/FU:I Outcome PT Other Blood Creatine Required Phosphokinase Increased Intervention to Muscle Rigidity Prevent Permanent Musculoskeletal Stiffness Impairment/Damage Neuroleptic Malignant Syndrome Neutrophil Count Increased Tachycardia White Blood Cell Count 22-Feb-2006 08:20 AM Page: 1684 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Risperdal PS ORAL 0.5MG PO TID Date:07/10/03ISR Number: 4145043-0Report Type:Direct Company Report #CTU 197680 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Risperdal Liquid 20d Initial or Prolonged Regressive Behaviour Taper To O From 3 Ml/D PS ORAL 1MG TID PO Zoloft Liquid 60mg/D 4/03->6/03 SS ORAL 60MG QD PO Date:07/10/03ISR Number: 4146686-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030701737 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:07/10/03ISR Number: 4146687-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030701745 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:07/10/03ISR Number: 4146688-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030700550 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Consumer Risperdal Initial or Prolonged Gait Disturbance (Risperidone) Tablets PS 0.5 MG, 2 IN 1 DAY Date:07/10/03ISR Number: 4146689-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030701244 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Risperdal Death Professional (Risperidone) Tablets PS Date:07/11/03ISR Number: 4148016-7Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20030700883 Age: Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged Disability 22-Feb-2006 08:20 AM Page: 1685 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Drug Toxicity Foreign Risperidone Gallbladder Disorder Consumer (Risperidone) PS Gastrooesophageal Reflux Disease Injury Lung Disorder Overdose Prescribed Overdose Respiratory Failure Vomiting Date:07/14/03ISR Number: 4146112-1Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0293076A Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Health Paxil PS Glaxosmithkline ORAL Initial or Prolonged Dyspnoea Professional Fluvoxamine Maleate SS ORAL Other Extrapyramidal Disorder Risperidone SS ORAL Muscle Rigidity Over Counter Cold Nasal Congestion Remedy SS ORAL 1 DAY Speech Disorder Vegetamin A SS ORAL Tongue Disorder Haloperidol C ORAL 1.5MG per day Lithium Carbonate C Glaxosmithkline ORAL 400MG per day Flunitrazepam C ORAL 2MG per day Biperiden Hydrochloride C ORAL 1MG per day Brotizolam C ORAL .5MG per day 12 DAY Date:07/14/03ISR Number: 4146405-8Report Type:Direct Company Report #CTU 197849 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Ketoacidosis Risperdal 3mg Hospitalization - Janssen PS Janssen ORAL 3MG PO TWICE Initial or Prolonged DAILY PO Required Diphenhydramine C Intervention to Prevent Permanent Impairment/Damage Date:07/14/03ISR Number: 4148540-7Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:36 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anorexia Initial or Prolonged Blood Creatine Phosphokinase Increased Blood Pressure Increased Condition Aggravated Delusion Diabetes Mellitus Hallucination Hypoventilation Hypoxia Insomnia 22-Feb-2006 08:20 AM Page: 1686 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Distress Schizophrenia Report Source Product Role Manufacturer Route Dose Duration Foreign Haloperidol Health (Haloperidol) Professional Tablets PS ORAL SEE IMAGE Risperdal (Risperidone) Tablets SS ORAL SEE IMAGE Quetiapine Fumarate (Quetiapine Fumarate) Tablets SS ORAL 600 MG, 1 IN 1 DAY, ORAL Hydroxyzine Pamoate (Hydroyzine Embonate) C Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Sennoside (All Other Therapeutic Products) C Date:07/14/03ISR Number: 4148546-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030700016 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Risperdal Initial or Prolonged Miosis Health (Risperidone) Overdose Professional Unspecified PS ORAL ORAL Tachycardia Depakote (Valproate Semisodium) C Deroxat (Paroxetine Hydrochloride) C Date:07/14/03ISR Number: 4148547-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030600298 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Foreign Risperidone Blood Potassium Increased Health (Risperidone) Condition Aggravated Professional Tablets PS ORAL 2 MG, 1 IN 1 Depression DAY, ORAL Diabetes Mellitus Warfarin Potassium Inadequate Control (Warfarin Potassium) Haemodialysis Tablets SS ORAL 2 MG, 1 IN 1 Renal Failure Chronic DAY, ORAL Restlessness Magnesium Oxide Suicide Attempt (Magnesium Oxide) Powder SS ORAL 1 G, 1 IN 1 DAY, ORAL Insulin (Insulin) Injection SS Candesartan 22-Feb-2006 08:20 AM Page: 1687 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cilexetil (Candesartan Cilexetil) Tablets SS ORAL 8 MG, 1 IN 1 DAY, ORAL Milnacipran Hydrochloride (Milnacipran Hydrochloride) C Date:07/14/03ISR Number: 4148548-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030701032 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Monocytopenia Foreign Risperidone Health (Risperidone) Professional Tablets PS ORAL 4 MG, 1 IN 1 DAY, ORAL Date:07/14/03ISR Number: 4148556-0Report Type:Expedited (15-DaCompany Report #EMADSS2003004284 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperdal Initial or Prolonged Hepatic Steatosis Health (Risperidone) PS ORAL 4 MG, ORAL Other Psychotic Disorder Professional Lyogen (Injection) Fluphenazine C Cipramil Citalopram Hydrobrmide C Date:07/14/03ISR Number: 4148557-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030701228 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal Blood Creatine Health (Risperidone) PS ORAL ORAL Phosphokinase Increased Professional Iron (Iron) C Renal Failure Vitamins (Vitamins) C Thrombophlebitis Date:07/14/03ISR Number: 4148735-2Report Type:Expedited (15-DaCompany Report #APCDSS2002000429 Age:36 YR Gender:Male I/FU:F Outcome PT Hospitalization - Anorexia Initial or Prolonged Blood Creatine Phosphokinase Increased Blood Glucose Increased Blood Pressure Increased Condition Aggravated Delusion Diabetes Mellitus Glycosylated Haemoglobin Increased Hallucination Hypoventilation Hypoxia Insomnia Po2 Increased 22-Feb-2006 08:20 AM Page: 1688 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Distress Schizophrenia Report Source Product Role Manufacturer Route Dose Duration Foreign Haloperidol Health (Haloperidol) Professional Tablets PS ORAL SEE IMAGE Risperdal (Risperidone) Tablets SS ORAL SEE IMAGE Quetiapine Fumarate (Quetiapine Fumarate) Tablets SS ORAL 600 MG, 1 IN 1 DAY, ORAL Hydroxyzine Pamoate (Hydroxyzine Embonate) C Estazolam (Estazolam) C Zopiclone (Zopiclone) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Sennoside (All Other Therapeutic Products) C Date:07/14/03ISR Number: 4149001-1Report Type:Expedited (15-DaCompany Report #2003028217 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Foreign Atarax (Tablet) Initial or Prolonged Health (Hydroxyzine Professional Hydrochloride) PS ORAL 75 MG (DAILY), ORAL Zoloft (Sertraline Hydrochloride) (Sertraline) SS ORAL EVERY OTHER DAY, ORAL Zopiclone (Zopiclone) SS ORAL 7.5 MG (DAILY), ORAL Lekovit Ca (Colecalciferol, Calcium Carbonate) SS ORAL ORAL Risperidone (Risperidone) SS ORAL 1.5 MG (DAILY), ORAL Tramadol Hydrochloride (Tramadol Hydrochloride) C ORAL 150 MG (DAILY), ORAL 22-Feb-2006 08:20 AM Page: 1689 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/03ISR Number: 4185314-5Report Type:Periodic Company Report #NSADSS2003005699 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Risperdal Syndrome Professional (Risperidone) Tablets PS ORAL ORAL .. C .. C Date:07/15/03ISR Number: 4147711-3Report Type:Direct Company Report #CTU 197950 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Risperidone PS ORAL 2 MG PO QD 6 WK Initial or Prolonged Difficulty In Walking Depakote C Disability Fall Lasix C Parkinsonism Date:07/15/03ISR Number: 4147712-5Report Type:Direct Company Report #CTU 197951 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Rigidity Risperidone PS ORAL 0.25 PO BID Initial or Prolonged Parkinsonism Lasix C Required Tremor Lisinopril C Intervention to Cipro C Prevent Permanent Lansoprazole C Impairment/Damage Metoprolol C Date:07/15/03ISR Number: 4149123-5Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20030701222 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypoglycaemia Foreign Risperdal Initial or Prolonged Health (Risperidone) Professional Tablets PS ORAL 1.5 MG, ORAL Glibenclamide (Glibenclamide) Tablets SS ORAL 0.5 MG, ORAL Date:07/15/03ISR Number: 4149306-4Report Type:Expedited (15-DaCompany Report #200312065GDS Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Ciproxine Initial or Prolonged Drug Interaction Health (Ciprofloxacin) PS ORAL 500 MG, BID, Sopor Professional ORAL Other Risperdal (Risperidone) SS ORAL 0.5 MG, BID, ORAL Talofen C Humalog C Normix C Calfolex C Laevolac "Boehringer Manheim" C Kanrenol C 22-Feb-2006 08:20 AM Page: 1690 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/15/03ISR Number: 4149489-6Report Type:Expedited (15-DaCompany Report #NSADSS2002005518 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Cancer Metastatic Health Risperdal Metastases To Spine Professional (Risperidone) Unspecified PS ORAL ORAL Date:07/15/03ISR Number: 4149493-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030701749 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL 3 MG, 2 IN 1 DAY, ORAL Date:07/15/03ISR Number: 4149494-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030701758 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Risperdal Bowel Sounds Abnormal Professional (Risperidone) Creatine Phosphokinase Unspecified PS ORAL 1 MG, 2 IN 1 Decreased DAY, ORAL Decreased Appetite Clozapine Difficulty In Walking (Clozapine) SS 100 MG, 3 IN Drug Interaction 1 DAY Drug Toxicity Benztropine Dysuria (Benztropeine) C Haematocrit Decreased Divalproex Haemoglobin Decreased (Valproate Lethargy Semisodium) C Pyelonephritis Lithium (Lithium) C Red Blood Cell Propranolol Sedimentation Rate (Propranolol) C Increased Levothyroxine Vomiting (Levothyroxine) C White Blood Cell Count Ferrous Sulfate (Ferrous Sulfate) C Multivitamins (Multivitamins) C Gemfibrozil (Gemfibrozil) C Pioglitazone (Pioglitazone) C Psyllium Powder (Psyllium) C Docusate/Casanthrano l (Peri-Colace) C Metformin (Metformin) C Date:07/16/03ISR Number: 4148345-7Report Type:Expedited (15-DaCompany Report #WAES 0307DEU00072 Age:81 YR Gender:Male I/FU:I Outcome Death Life-Threatening 22-Feb-2006 08:20 AM Page: 1691 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hospitalization - Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Death Vioxx PS Merck & Co., Inc ORAL Dialysis Enalapril Maleate SS ORAL Drug Interaction Risperidone SS ORAL Duodenal Ulcer Olanzapine SS ORAL Haemorrhage Esomeprazole Renal Failure Magnesium SS ORAL Furosemide Sodium SS ORAL Date:07/16/03ISR Number: 4150137-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030701646 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sinus Arrhythmia Foreign Risperdal Supraventricular Health (Risperidone) Extrasystoles Professional Unspecified PS ORAL 0.75 MG, ORAL Date:07/16/03ISR Number: 4150141-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030700011 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Risperdal Initial or Prolonged Drug Effect Increased Health (Risperidone) Prothrombin Time Professional Unspecified PS ORAL SEE IMAGE Shortened Marcumar Pulmonary Embolism (Phenprocoumon) SS Weight Increased Zyprexa (Olanzapine) C Nizax (Nizatidine) C Pantozol (Pantoprazole Sodium) C Date:07/16/03ISR Number: 4150478-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030701077 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Risperdal Health (Risperidone) PS 0.5 MG, 2 IN Professional 1 DAY Citalopram (Citalopram) C Temazepam (Temazepam) C Lactulose (Lactulose) C Date:07/16/03ISR Number: 4150883-8Report Type:Expedited (15-DaCompany Report #NSADSS2002029547 Age:89 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL SEE IMAGE Nortriptyline (Nortriptyline) C 22-Feb-2006 08:20 AM Page: 1692 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trazodone (Trazodone) C Atarax (Hydroxyzine Hydrochloride) C Date:07/16/03ISR Number: 4150884-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030701988 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Tablets PS 0.5 MG, 2 IN 1 DAY Date:07/16/03ISR Number: 4150887-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030703197 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:07/16/03ISR Number: 4150889-9Report Type:Expedited (15-DaCompany Report #NSADSS2002015035 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 3 MG, 2 IN 1 DAY, ORAL Ativan (Lorazepam) C Artane (Trihexyphenidyl Hydrochloride) C Doxepin (Doxepin) C Date:07/16/03ISR Number: 4150890-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030702990 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 3 MBQ, 1 IN 1 DAY, ORAL Date:07/16/03ISR Number: 4150951-0Report Type:Expedited (15-DaCompany Report #2003167289DE Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Celecoxib Vs Increased Study Placebo(Code Not Aspartate Health Broken) (Celecoxib) Aminotransferase Professional Capsule PS 200 MG, BID Increased Other Comparator-Risperido Blood Creatine ne(Risperidone) Phosphokinase Increased Tablet SS ORAL 5 MG, BID, ORAL Tavor C 22-Feb-2006 08:20 AM Page: 1693 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ximovan C Date:07/17/03ISR Number: 4151101-7Report Type:Expedited (15-DaCompany Report #NSADSS2003019099 Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Risperdal Initial or Prolonged Professional (Risperidone) Other Company Unspecified PS ORAL ORAL Representative Reminyl (Galantamine) Unspecified SS ORAL ORAL Date:07/17/03ISR Number: 4151104-2Report Type:Expedited (15-DaCompany Report #NSADSS2002007215 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Date:07/17/03ISR Number: 4151110-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030703153 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Generalised Oedema Health Risperdal Professional (Risperidone) Company Unspecified PS ORAL ORAL Representative Date:07/17/03ISR Number: 4151239-4Report Type:Expedited (15-DaCompany Report #EMADSS2003004117 Age:7 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Risperidone Bladder Pain Health (Risperidone) Haematuria Professional Unspecified PS 0.75 MG, 1 IN Inguinal Hernia 1 DAY Pyrexia Date:07/18/03ISR Number: 4149150-8Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12304044 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Fluphenazine Hcl PS Apothecon INTRAMUSCULAR Initial or Prolonged Somnolence Risperidone SS ORAL 1MG in a.m. & Urinary Tract Infection 2MG in p.m. Lorazepam SS ORAL 1MG nocte 22-Feb-2006 08:20 AM Page: 1694 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/03ISR Number: 4150740-7Report Type:Direct Company Report #CTU 198199 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Athetosis Risperdal 2mg A.M. Intervention to Dysarthria And 3mg H.S. Po PS Prevent Permanent Tardive Dyskinesia Abilify C Impairment/Damage Date:07/18/03ISR Number: 4151809-3Report Type:Expedited (15-DaCompany Report #20030703951 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Risperdal Cardiovascular Disorder Health (Risperidone) Dehydration Professional Unspecified PS ORAL ORAL Hypotension Respiratory Failure Date:07/18/03ISR Number: 4151810-XReport Type:Expedited (15-DaCompany Report #NSADSS2003002271 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Risperdal Initial or Prolonged Anxiety Consumer (Risperidone) Delusion Unspecified PS ORAL SEE IMAGE Insomnia Ritalin (Tablets) Mental Disorder Methylphenidate Paranoia Hydrochloride C Physical Assault Alesse 28 Psychotic Disorder (Unspecified) School Refusal Eugynon C Social Avoidant Behaviour Suicide Attempt Treatment Noncompliance Weight Decreased Date:07/18/03ISR Number: 4151821-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030703313 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Foreign Risperidone Galactorrhoea Health (Risperidone) PS ORAL ORAL Gynaecomastia Professional Other Date:07/18/03ISR Number: 4152772-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030703985 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone)Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1695 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/03ISR Number: 4154072-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030704282 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL Date:07/18/03ISR Number: 4154079-5Report Type:Expedited (15-DaCompany Report #NSADSS2002005183 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL 1 MG, 2 IN 1 DAY, ORAL Date:07/21/03ISR Number: 4152818-0Report Type:Expedited (15-DaCompany Report #PHRM2003FR01330 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - B-Cell Lymphoma Foreign Leponex Initial or Prolonged Leukocytosis Health (Clonzapine) PS ORAL 400 MG/DAY, Lymphocytosis Professional ORAL Other Risperdal (Risperidone) SS ORAL 12 MG/DAY, ORAL Parkinaine (Trihexyphenidyl Hydrochloride) Slow Release C Valium Tablet C Lipanthyl (Fenofibrate) C Fournier Date:07/22/03ISR Number: 4151971-2Report Type:Direct Company Report #CTU 198386 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperidone Initial or Prolonged Phosphokinase Increased (Risperdal) 3mg By Neuroleptic Malignant Janssen PS Janssen ORAL 3MG QHS PO Syndrome UPON Psychotic Disorder ADMISSION 1MG BID PO UPON DISCHARGING Diphehydramine C Lorazepam C Acetaminophen C Date:07/22/03ISR Number: 4154596-8Report Type:Expedited (15-DaCompany Report #NSADSS2002009379 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal (Risperidone) PS ORAL ORAL Aricept (Donepezil Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1696 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nitroglycerin (Glyceryl Trinitrate) C Multivitamin (Multivitamins) C Zantac (Ranitidine Hydrochloride) C Date:07/22/03ISR Number: 4154597-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030704285 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:07/23/03ISR Number: 4154417-3Report Type:Expedited (15-DaCompany Report #IL-JNJFOC-20030703335 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Risperidone) PS 4 MG Professional Clonazepam (Clonazepam) C Date:07/23/03ISR Number: 4155086-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030704994 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Date:07/23/03ISR Number: 4155092-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030602893 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS 1 MG, 2 IN 1 DAY Date:07/23/03ISR Number: 4155104-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030704995 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1697 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/03ISR Number: 4155775-6Report Type:Expedited (15-DaCompany Report #2003029529 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Zoloft (Oral Conc) Initial or Prolonged Dyskinesia Professional (Sertraline) PS ORAL 60 MG Movement Disorder (DAILY), ORAL Regressive Behaviour Risperidone (Risperidone) SS ORAL 3 MG (TID), ORAL Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) C Date:07/24/03ISR Number: 4156111-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030705387 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL Date:07/24/03ISR Number: 4156113-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030705062 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL Date:07/24/03ISR Number: 4156354-7Report Type:Expedited (15-DaCompany Report #DSA_22996_2003 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dialysis Foreign Enalapril Maleate PS ORAL 5 MG QD PO Life-Threatening Drug Interaction Health Rofecoxib SS ORAL 25 MG UNK PO Hospitalization - Duodenal Ulcer Professional Risperdal SS ORAL 1.5 MG QD PO Initial or Prolonged Haemorrhage Other Zyprexa SS ORAL 10 MG QD PO Renal Failure Nexium SS 20 MG BID Lasix SS ORAL 40 MG QD PO Date:07/24/03ISR Number: 4156373-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030705421 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Health Risperdal Initial or Prolonged Cerebrovascular Accident Professional (Risperidone) Renal Failure Tablets PS ORAL 3 MG, 1 IN 1 DAY, ORAL Seroquel (Quetiapine Fumarate) C Serzone (Nefazodone Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1698 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/03ISR Number: 4156499-1Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20030700085 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aortic Calcification Foreign Reminyl(Galantamine) Aphasia Health (Unspecified) PS ORAL 8 MG, 1 IN 1 Cardiomegaly Professional DAY, ORAL Chest Discomfort Risperdal Dementia (Risperidone) Electrocardiogram T Wave (Tablet) SS ORAL 1 MG, 1 IN 1 Amplitude Decreased DAY, ORAL Extrapyramidal Disorder Hypoventilation Memory Impairment Parkinsonism Pyuria Date:07/24/03ISR Number: 4156856-3Report Type:Expedited (15-DaCompany Report #PL-JNJFOC-20030703385 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Rispolet Health (Risperidone) PS Professional Dipiperon (Pipamperone) C Calcium C Date:07/24/03ISR Number: 4156858-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030603422 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholinesterase Foreign Risperdal Decreased Health (Risperidone) PS ORAL 0.5 MG, ORAL Professional Dipiperon (Pipamperone) C Calcium C Date:07/24/03ISR Number: 4156860-5Report Type:Expedited (15-DaCompany Report #APCDSS2003000662 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperidone Sinus Bradycardia Health (Risperidone) PS ORAL SEE IMAGE Professional Risperidone Tablets SS ORAL 1 MG, 1 IN 1 DAY, ORAL Risperidone Solution SS ORAL 3 MG, 1 IN 1 DAY, ORAL Haloperidol SS Diazepam Powder SS ORAL 15 MG, 1 IN 1 DAY, ORAL Biperiden Hydrochloride C Sodium Valproate (Valproate Sodium) C Carbamazepine C Flunitrazepam C Levomepromazine Maleate C Trihexyphenidyl 22-Feb-2006 08:20 AM Page: 1699 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride C Bromperidol C Date:07/24/03ISR Number: 4156861-7Report Type:Expedited (15-DaCompany Report #EMADSS2003004117 Age:7 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Inguinal Hernia Foreign Risperidone PS 0.75 MG, 1 IN Pyrexia Health 1 DAY Urinary Bladder Rupture Professional Date:07/25/03ISR Number: 4153926-0Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0363979A Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Paxil PS Glaxosmithkline ORAL Anger Risperdal SS Delusion Drug Toxicity Drug Withdrawal Syndrome Mental Status Changes Murder Negativism Date:07/25/03ISR Number: 4154841-9Report Type:Direct Company Report #CTU 198710 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Accident Resperdal PS Hospitalization - Loss Of Consciousness Initial or Prolonged Date:07/25/03ISR Number: 4154936-XReport Type:Direct Company Report #CTU 198699 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Risperdal 2mg PS ORAL QAM PO Extrapyramidal Disorder Risperdal 3mg SS ORAL QPM PO Date:07/25/03ISR Number: 4154944-9Report Type:Direct Company Report #CTU 198702 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Risperdal 0.25 Mg PS ORAL QHS PO Date:07/28/03ISR Number: 4155379-5Report Type:Direct Company Report #CTU 198747 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Haemorrhage Risperdal 1mg/Ml Initial or Prolonged Cerebrovascular Accident Janssen PS Janssen ORAL 0.5MG QAM AND Other QHS ORAL Risperdal 1mg/Ml Janssen SS Janssen ORAL 0.5MG Q1200 ORAL Aspirin C 22-Feb-2006 08:20 AM Page: 1700 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Apap C Catapres Tts-2 C Donepezil C Mom C Lorazepam C Sertraline C Date:07/28/03ISR Number: 4158101-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601832 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Decubitus Ulcer Health Risperdal General Physical Health Professional (Risperidone) Deterioration Unspecified PS 0.25 MG, 1 IN 1 DAY Aricept (Donepezil Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Date:07/28/03ISR Number: 4158103-5Report Type:Expedited (15-DaCompany Report #NSADSS2002009796 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Contusion Consumer Risperdal Thrombocytopenia (Risperidone) Tablets PS ORAL 0.5-1 MG, 1 IN 1 DAY, ORAL Synthroid (Levothyroxine Sodium) C Date:07/28/03ISR Number: 4158104-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030705675 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Risperdal Hospitalization - Cardiomegaly Professional (Risperidone) Initial or Prolonged Tablets PS ORAL 1 MG, 2 IN 1 DAY, ORAL Date:07/28/03ISR Number: 4158288-0Report Type:Expedited (15-DaCompany Report #2003028963 Age:45 YR Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Discomfort Initial or Prolonged Alanine Aminotransferase Aspartate Aminotransferase Blood Bilirubin Blood Lactate Dehydrogenase C-Reactive Protein Drug Hypersensitivity Gamma-Glutamyltransferase Haemoglobin 22-Feb-2006 08:20 AM Page: 1701 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatic Function Abnormal Infection Platelet Count Report Source Product Role Manufacturer Route Dose Duration Pyrexia Foreign Lipitor Rash Health (Atorvastatin) PS ORAL 10 MG White Blood Cell Count Professional (DAILY), ORAL Olanzapine (Olanzapine) SS ORAL 10 MG (DAILY), ORAL Allopurinol (Allopurinol) SS ORAL 100 MG (DAILY), ORAL Risperidone (Risperidone) SS ORAL 4 MG (DAILY), ORAL Vegetamin A (Phenobarbital, Promethazine, Chlorpromazine Hydrochloride) SS ORAL 1 DF (DAILY), ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) SS ORAL 2 MG (DAILY), ORAL Cloxazolam (Cloxazolam) C Date:07/28/03ISR Number: 4158323-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030701032 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Monocytopenia Foreign Risperidone Health (Risperidone) Professional Tablets PS ORAL 4 MG, 1 IN 1 DAY, ORAL Zotepine (Zotepine) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:07/29/03ISR Number: 4156431-0Report Type:Direct Company Report #CTU 198831 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal 3mg Jansen PS Jansen ORAL ONE QHS ORAL Date:07/29/03ISR Number: 4156432-2Report Type:Direct Company Report #CTU 198832 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Risperdal 2mg Ventricular Fibrillation Janssen PS ORAL ONE BID ORAL Depakote 250 Mg Abbott SS Abbott ORAL ONE BID ORAL 22-Feb-2006 08:20 AM Page: 1702 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/03ISR Number: 4156738-7Report Type:Expedited (15-DaCompany Report #WAES 0307USA02753 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Judgement Impaired Cogentin PS Merck & Co., Inc ORAL Initial or Prolonged Risperdal SS Paxil SS Desyrel SS Date:07/29/03ISR Number: 4158575-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601830 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Health Risperdal Increased Professional (Risperidone) Blood Prolactin Increased Unspecified PS 0.5 MG, 2 IN Blood Urea Increased 1 DAY White Blood Cell Count Depakote (Valproate Decreased Semisodium) C Prozac (Fluoxetine Hydrochloride) C Date:07/29/03ISR Number: 4158577-XReport Type:Expedited (15-DaCompany Report #NSADSS2003015591 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Consumer Risperdal Myocardial Infarction (Risperidone) Tablets PS ORAL 1 MG, 2 IN 24 HOUR, ORAL Xanax () Alprazolam C Date:07/29/03ISR Number: 4158732-9Report Type:Expedited (15-DaCompany Report #NSADSS2003015591 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Consumer Risperdal Dementia (Risperidone) Myocardial Infarction Tablets PS ORAL 1 MG, 2 IN 24 HOUR, ORAL Xanax (Alprazolam) C Date:07/29/03ISR Number: 4158733-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030706158 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:07/29/03ISR Number: 4158736-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601830 Age:9 YR Gender:Male I/FU:F Outcome PT Other Blood Creatinine Increased Blood Prolactin Increased 22-Feb-2006 08:20 AM Page: 1703 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Urea Increased White Blood Cell Count Decreased Report Source Product Role Manufacturer Route Dose Duration Health Risperdal Professional (Risperidone) Unspecified PS 0.5 M G, 2 IN 1 DAY Dapakote (Valproate Semisodium) C Prozac (Fluoxetine Hydrochloride) C Date:07/29/03ISR Number: 4159576-4Report Type:Expedited (15-DaCompany Report #2003028217 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Atarax (Tablet) Initial or Prolonged Epilepsy Health (Hydroxyzine Other Femoral Neck Fracture Professional Hydrochloride) PS ORAL 75 MG (TID), Loss Of Consciousness ORAL Malaise Zoloft (Sertraline Syncope Hydrochloride) Upper Limb Fracture (Sertraline) SS ORAL EVERY OTHER DAY, ORAL Tramadol Hydrochloride (Tramadol Hydrochloride) SS ORAL 150 MG (TID), ORAL Zopiclone (Zopiclone) SS ORAL 7.5 MG (DAILY), ORAL Risperidone (Risperidone) SS ORAL 1.5 MG (BID), ORAL Levokit Ca (Colecalciferol, Calcium Carbonate) SS ORAL DAILY, ORAL Date:07/29/03ISR Number: 4159594-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030705967 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Osteoarthritis Foreign Risperdal Osteoporosis Health (Risperidone) Professional Unspecified PS Date:07/29/03ISR Number: 4159595-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030704686 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Restless Legs Syndrome Foreign Risperdal Tardive Dyskinesia Health (Risperidone) Professional Tablets PS ORAL 4 MG, 1 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1704 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/03ISR Number: 4160535-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030704686 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Restless Legs Syndrome Foreign Risperdal Tardive Dyskinesia Health (Risperidone) Professional Tablets PS ORAL 4 MG, 1 IN 1 DAY, ORAL Date:07/29/03ISR Number: 4160538-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030705967 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthritis Foreign Risperdal Osteoporosis Health (Risperidone) Professional Unspecified PS Date:07/31/03ISR Number: 4161591-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030706321 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, 1 IN 1 DAY, ORAL Valproic Aicd () Valproic Acid C Paxil () Paroxetine Hydrochloride C Trazodone () Trazodone C Wellbutrin (Bupropion Hydrochloride) C Date:07/31/03ISR Number: 4161997-0Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20030706429 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Topamax (Topiramate) PS ORAL ORAL Initial or Prolonged Polyneuropathy Health Risperdal Professional (Risperidone) SS ORAL ORAL Date:07/31/03ISR Number: 4184824-4Report Type:Periodic Company Report #NSADSS2003000452 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gait Disturbance Consumer Risperdal Initial or Prolonged Social Avoidant Behaviour (Risperidone) Tablets PS ORAL 1 MG, 2 IN DAY, ORAL; 2 MG, 2 IN DAY, ORAL; 3 MG, 2 IN DAY, ORAL 22-Feb-2006 08:20 AM Page: 1705 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/03ISR Number: 4184827-XReport Type:Periodic Company Report #NSADSS2003000275 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Consumer Risperdal Initial or Prolonged Health (Risperidone) PS Professional Date:07/31/03ISR Number: 4184830-XReport Type:Periodic Company Report #NSADSS2002047751 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Ejaculation Failure Professional (Risperidone) Tablets PS 6 MG, ORAL Depakote (Valproate Semisodium) C Protonix (Pantoprazole) C Date:07/31/03ISR Number: 4184832-3Report Type:Periodic Company Report #NSADSS2002046743 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Risperdal Syndrome Professional (Risperidone) Company Unspecified PS ORAL ORAL Representative Date:07/31/03ISR Number: 4184838-4Report Type:Periodic Company Report #NSADSS2002046629 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ejaculation Disorder Health Risperdal Initial or Prolonged Psychotic Disorder Professional (Risperidone) Tablets PS ORAL 3 MG, 1 IN DAY, ORAL Date:07/31/03ISR Number: 4184847-5Report Type:Periodic Company Report #NSADSS2002046390 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal Professional (Risperidone) Company Unspecified PS ORAL Representative Date:07/31/03ISR Number: 4184850-5Report Type:Periodic Company Report #NSADSS2002045678 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Professional (Risperidone) Company Unspecified PS ORAL Representative 22-Feb-2006 08:20 AM Page: 1706 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/03ISR Number: 4184853-0Report Type:Periodic Company Report #NSADSS2002045675 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Risperdal Convulsion (Risperidone) Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL; 0.5 MG, 2 IN 1 DAY, ORAL Multivitamin (Capsules) Multivitamins C Vibramycin (Unspecified) Doxycycline Hyclate C Date:07/31/03ISR Number: 4184857-8Report Type:Periodic Company Report #NSADSS2002045362 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Risperdal Dizziness (Risperidone) Dry Mouth Tablets PS 2 MG, 1 IN 1 Somnolence DAY, ORAL Zoloft (Sertraline Hydrochloride) C Ativan (Lorazepam ) C Date:07/31/03ISR Number: 4184860-8Report Type:Periodic Company Report #NSADSS2002044562 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Health Risperdal Other Pneumonia Professional (Risperidone) Thrombocytopenia Unspecified PS ORAL 3 MG, 2 IN 1 DAY, ORAL Lasix (Unspecified) Furosemide C Potassium Chloride (Unspecified) Potassium Chloride C Lorazepam (Lorazepam) Unspecified C Date:07/31/03ISR Number: 4184898-0Report Type:Periodic Company Report #NSADSS2002043691 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Professional (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1707 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/03ISR Number: 4184903-1Report Type:Periodic Company Report #NSADSS2002043687 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Risperdal Initial or Prolonged Liver Function Test Professional (Risperidone) PS ORAL ORAL Abnormal Aripiprazole Neuroleptic Malignant (Aripiprazole) SS Syndrome Psychotic Disorder Suicidal Ideation Urinary Retention Date:07/31/03ISR Number: 4184906-7Report Type:Periodic Company Report #NSADSS2002039532 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperdal Initial or Prolonged Professional (Risperidone) Company Tablets PS ORAL 3 MG, 2 IN 1 Representative DAY, ORAL Risperdal (Risperidone) SS ORAL 2 MG, 2 IN 1 DAY, ORAL Adderal Xr (Obetrol) Tablets SS ORAL 1 IN 1 DAY, ORAL Depakote (Valproate Semisodium) C Date:07/31/03ISR Number: 4184910-9Report Type:Periodic Company Report #NSADSS2002021447 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Health Risperdal Dyskinesia Professional (Risperidone) PS ORAL 1, 2 IN DAY, Dyspnoea ORAL Enuresis Risperdal (Risperidone) SS 1 MG, 2 IN DAY Ritalin (Methylphenidate Hydrochloride) Tablets C Date:07/31/03ISR Number: 4184911-0Report Type:Periodic Company Report #NSADSS2002019508 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal Professional (Risperidone) Tablets PS ORAL 1.5 MG, ORAL Depakote ( ) Valproate Sodium C 22-Feb-2006 08:20 AM Page: 1708 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/03ISR Number: 4184912-2Report Type:Periodic Company Report #NSADSS2002018961 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Venous Thrombosis Health Risperdal Required Professional (Risperidone) PS ORAL 1.25 MG, ORAL Intervention to Prevent Permanent Impairment/Damage Date:07/31/03ISR Number: 4184915-8Report Type:Periodic Company Report #NSADSS2002001145 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancreatitis Health Risperdal Professional (Risperidone) PS 6 - 7 MG DAILY Lithobid (Lithium Carbonate) C Trazodone (Trazodone) C Date:07/31/03ISR Number: 4184921-3Report Type:Periodic Company Report #NSADSS2003017777 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Risperdal (Risperidone) Tablets PS ORAL ORAL Date:07/31/03ISR Number: 4184924-9Report Type:Periodic Company Report #NSADSS2003017619 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Health Risperdal Attack Professional (Risperidone) Unspecified PS ORAL ORAL Date:07/31/03ISR Number: 4184926-2Report Type:Periodic Company Report #NSADSS2003017613 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Risperdal Company (Risperidone) Representative Unspecified PS ORAL Date:07/31/03ISR Number: 4184937-7Report Type:Periodic Company Report #NSADSS2003016742 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Risperdal Initial or Prolonged Professional (Risperidone) Company Unspecified PS 2 Representative 22-Feb-2006 08:20 AM Page: 1709 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/03ISR Number: 4184941-9Report Type:Periodic Company Report #NSADSS2003016036 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal Professional (Risperidone) Unspecified PS Date:07/31/03ISR Number: 4184943-2Report Type:Periodic Company Report #NSADSS2003015267 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Consumer Risperdal Syndrome Health (Risperidone) Professional Tablets PS ORAL ORAL Haldol (Unspecified) Haloperidol Decanoate C Decanoate C Date:07/31/03ISR Number: 4184944-4Report Type:Periodic Company Report #NSADSS2003014591 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Consumer Risperdal Initial or Prolonged Urinary Retention (Risperidone) Tablets PS ORAL 1 IN 1 DAY , ORAL Date:07/31/03ISR Number: 4184945-6Report Type:Periodic Company Report #NSADSS2003014609 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Consumer Risperdal Initial or Prolonged Hyperprolactinaemia (Risperidone) Tablets PS ORAL 4MG, 1 IN 1 DAY, ORAL Date:07/31/03ISR Number: 4184947-XReport Type:Periodic Company Report #NSADSS2003014305 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 5 MG, ORAL Date:07/31/03ISR Number: 4184948-1Report Type:Periodic Company Report #NSADSS2003013561 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Risperdal Initial or Prolonged Phosphokinase Increased Professional (Risperidone) Pyrexia Tablets PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1710 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/03ISR Number: 4184950-XReport Type:Periodic Company Report #NSADSS2003022352 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Risperdal Initial or Prolonged Professional (Risperidone) Tablets PS ORAL 1 MG, 2 IN 1 DAY, ORAL Lordis () All Other Therapeutic Products C Neurontin () Gabapentin C Norvasc () Amlodipine Besilate C Avandia (Rosigltazone Maleate) C Lipitor (Atorvastatin) C Metoprolol (Metoprolol) C Lotensin (Benazepril Hydrochloride) C Plavix (Clopidogrel Sulfate) C Diclofenac (Diclofenac) C Lorazepam (Lorazepam) C Quinine (Quinine) C Hydrocodone (Hydrocodone) C Doxepin (Doxepin) C Humalog (Insulin Lispro) C Meclozine (Meclozine) C Date:07/31/03ISR Number: 4184964-XReport Type:Periodic Company Report #NSADSS2003022069 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Risperdal Professional (Risperidone) Tablets PS 2 MG, 2 IN 24 HOUR, ORAL Lithobid () Lithium Carbonate C Ativan () Lorazepam C Date:07/31/03ISR Number: 4184967-5Report Type:Periodic Company Report #NSADSS2003021746 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal Professional (Risperidone) PS ORAL ORAL Company Depakote ( ) Representative Valproate Semisodium C 22-Feb-2006 08:20 AM Page: 1711 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/03ISR Number: 4184971-7Report Type:Periodic Company Report #NSADSS2003021743 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Risperdal (Risperidone) Tablets PS ORAL ORAL Date:07/31/03ISR Number: 4184974-2Report Type:Periodic Company Report #NSADSS2003021460 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Health Risperdal Attack Professional (Risperidone) Company Tablets PS 0.25 MG, 1 IN Representative 1 DAY, ORAL Date:07/31/03ISR Number: 4184978-XReport Type:Periodic Company Report #NSADSS2003021082 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL Date:07/31/03ISR Number: 4185013-XReport Type:Periodic Company Report #NSADSS2003020307 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertriglyceridaemia Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL Date:07/31/03ISR Number: 4185015-3Report Type:Periodic Company Report #NSADSS2003020430 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Consumer Risperdal Transient Ischaemic (Risperidone) Attack Tablets PS ORAL 0.75 MG; 0.25 :ORAL Diavon () All Other Therapeutic Products C Synthroid (Levothyroxine Sodium) C Tylenol (Paracetamol) C Hydrocodone (Hydrocodone) C Date:07/31/03ISR Number: 4185016-5Report Type:Periodic Company Report #NSADSS2003020481 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Disorder Health Risperdal Professional (Risperidone) 22-Feb-2006 08:20 AM Page: 1712 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablets PS ORAL ORAL Date:07/31/03ISR Number: 4185026-8Report Type:Periodic Company Report #NSADSS2003020490 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal Professional (Risperidone) Tablets PS ORAL 6 MG, ORAL Date:07/31/03ISR Number: 4185028-1Report Type:Periodic Company Report #NSADSS2003020179 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Risperdal Transient Ischaemic (Risperidone) Attack Tablets PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Zoloft (Tablets) Sertraline Hydrochloride C Naproxen Sodium Naproxen Sodium C Date:07/31/03ISR Number: 4185030-XReport Type:Periodic Company Report #NSADSS2003019998 Age:97 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Transient Ischaemic Consumer Risperdal Initial or Prolonged Attack (Risperidone) Tablets PS ORAL 0.5 MG, 1 IN 24 HOUR, ORAL Hctz/Reserpine ( ) Hydrochlorothiazide C Norvasc () Amlodipine Besilate C Atenolol () Atenolol C Nitro (Gyceryl Trinitrate) C Famotidine (Famotidine) C Amitriptyline (Amitriptyline) C Salsalate (Salsalate) C Citricel (All Other Therapeutic Products) C Date:07/31/03ISR Number: 4185032-3Report Type:Periodic Company Report #NSADSS2003019990 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Risperdal Initial or Prolonged Professional (Risperidone) Tablets PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1713 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/03ISR Number: 4185034-7Report Type:Periodic Company Report #NSADSS2003019733 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Risperdal (Risperidone) Tablets PS ORAL 0.25 MG, 2 IN 24 HOUR, ORAL Date:07/31/03ISR Number: 4185036-0Report Type:Periodic Company Report #NSADSS2003019099 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Risperdal Professional (Risperidone) Company Tablets PS ORAL ORAL Representative Reminyl (Galantamine) SS ORAL ORAL Date:07/31/03ISR Number: 4185039-6Report Type:Periodic Company Report #NSADSS2003019078 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Health Risperdal Attack Professional (Risperidone) Tablets PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Reminyl (Galantamine) C Zoloft (Tablets) Sertraline Hydrochloride C Periactin (Cyproheptadine Hydrochloride) C Date:07/31/03ISR Number: 4185040-2Report Type:Periodic Company Report #NSADSS2003018890 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Consumer Risperdal Attack (Risperidone) Tablets PS ORAL 2 MG, 1 IN 1 DAY, ORAL Zoloft (Sertraline Hydrochloride) C Norvasc (Amlodipine Besilate C Date:07/31/03ISR Number: 4185041-4Report Type:Periodic Company Report #NSADSS2003018413 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal Initial or Prolonged Condition Aggravated (Risperidone) Insomnia Tablets PS ORAL 6 MG ; 4 MG Mania : 1 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1714 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote (Valproate Semisodium) C Date:07/31/03ISR Number: 4185043-8Report Type:Periodic Company Report #NSADSS2003018083 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Consumer Risperdal Apathy (Risperidone) Cerebrovascular Accident Tablets PS ORAL 0.25 MG, 2 IN DAY, ORAL Aspirin () Acetylsalicylic Acid C Cartia () Acetylsalicylic Acid C Lorazepam ( ) Lorazepam C Date:07/31/03ISR Number: 4185046-3Report Type:Periodic Company Report #NSADSS2003017818 Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Consumer Risperdal Attack (Risperidone) Tablets PS ORAL ORAL Date:07/31/03ISR Number: 4185049-9Report Type:Periodic Company Report #NSADSS2003024530 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Consumer Risperdal Health (Risperidone) PS Professional Date:07/31/03ISR Number: 4185051-7Report Type:Periodic Company Report #NSADSS2003024380 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Professional (Risperidone) Tablets PS ORAL ORAL Date:07/31/03ISR Number: 4185053-0Report Type:Periodic Company Report #NSADSS2003024374 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 0.25 MG, 1 IN 24 HOUR, ORAL Klonopin () Clonazepam C 22-Feb-2006 08:20 AM Page: 1715 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/03ISR Number: 4185054-2Report Type:Periodic Company Report #NSADSS2003023963 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Risperdal (Risperidone) PS ORAL ORAL Date:07/31/03ISR Number: 4185056-6Report Type:Periodic Company Report #NSADSS2003023975 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Risperdal Professional (Risperidone) Tablets PS 0.25 MG, ORAL Depakote (Tablets) Valproate Semisodium C Topamax Topiramate C Date:07/31/03ISR Number: 4185058-XReport Type:Periodic Company Report #NSADSS2003023983 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone) Company Tablets PS ORAL 0.25 MG, 1 IN Representative 1 DAY, ORAL Triletta (All Other Therapeutic Products) SS ORAL 75 MG, 1 IN 1 DAY, ORAL Adderall (Obetrol) Tablets C Date:07/31/03ISR Number: 4185060-8Report Type:Periodic Company Report #NSADSS2003024110 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Risperdal Initial or Prolonged Professional (Risperidone) Tablets PS ORAL 2 MG ; 3MG : 1 IN 1 DAY, ORAL Insulin () Insulin C Date:07/31/03ISR Number: 4185061-XReport Type:Periodic Company Report #NSADSS2003023888 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1716 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/03ISR Number: 4185064-5Report Type:Periodic Company Report #NSADSS2003023884 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Risperdal Professional (Risperidone) Tablets PS Date:07/31/03ISR Number: 4185074-8Report Type:Periodic Company Report #NSADSS2003023736 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Risperdal (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Date:07/31/03ISR Number: 4185302-9Report Type:Periodic Company Report #NSADSS2003006516 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL Date:07/31/03ISR Number: 4185306-6Report Type:Periodic Company Report #NSADSS2003006180 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL Clozapine (Clozapine) C Date:07/31/03ISR Number: 4185309-1Report Type:Periodic Company Report #NSADSS2003006166 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperdal Initial or Prolonged Professional (Risperidone) Tablets PS ORAL 6 MG, 1 IN 1 DAY, ORAL Date:07/31/03ISR Number: 4185317-0Report Type:Periodic Company Report #NSADSS2003005694 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Initial or Prolonged Syndrome Professional (Risperidone) Other Company Tablets PS ORAL 1 MG, 2 IN 24 Representative HOUR, ORAL Paxil Cr (Paroxetine Hydrochloride) C Ativan (Lorazepam) C 22-Feb-2006 08:20 AM Page: 1717 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/03ISR Number: 4185322-4Report Type:Periodic Company Report #NSADSS2003004435 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Professional (Risperidone) Company Unspecified PS Representative Date:07/31/03ISR Number: 4185327-3Report Type:Periodic Company Report #NSADSS2003002755 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Consumer Risperdal Initial or Prolonged Epistaxis (Risperidone) Headache Tablets PS ORAL ORAL Date:07/31/03ISR Number: 4185330-3Report Type:Periodic Company Report #NSADSS2003002707 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Risperdal Initial or Prolonged Constipation (Risperidone) Disability Depression Unspecified PS ORAL SEE IMAGE Fatigue Celexa (Citalopram Muscle Rigidity Hydrobromide) C Suicide Attempt Clozaril (Clozapine) C Date:07/31/03ISR Number: 4185332-7Report Type:Periodic Company Report #NSADSS2003001573 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Red Blood Cell Count Health Risperdal Decreased Professional (Risperidone) Tablets PS ORAL 4MG, 1 IN 1 DAY, ORAL Date:07/31/03ISR Number: 4185340-6Report Type:Periodic Company Report #NSADSS2003001570 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Red Blood Cell Count Health Risperdal Decreased Professional (Risperidone) Company Tablets PS ORAL ORAL Representative Date:07/31/03ISR Number: 4186067-7Report Type:Periodic Company Report #NSADSS2003013296 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Risperdal Initial or Prolonged Prolonged Professional (Risperidone) Hypokalaemia Unspecified PS ORAL ORAL Hyponatraemia Hypotension Sedation 22-Feb-2006 08:20 AM Page: 1718 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/03ISR Number: 4186069-0Report Type:Periodic Company Report #NSADSS2003012501 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Consumer Risperdal Syndrome (Risperidone) Tablets PS ORAL ORAL Depakote (Valproate Semisodium) SS ORAL ORAL Date:07/31/03ISR Number: 4186071-9Report Type:Periodic Company Report #NSADSS2003011016 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL ORAL Company Representative Date:07/31/03ISR Number: 4186073-2Report Type:Periodic Company Report #NSADSS2003009207 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Professional (Risperidone) Unspecified PS ORAL ORAL Date:07/31/03ISR Number: 4186077-XReport Type:Periodic Company Report #NSADSS2003009862 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Aricept (Unspecified) Donepezil Hydrochloride C Date:07/31/03ISR Number: 4186078-1Report Type:Periodic Company Report #NSADSS2003009382 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Health Rispderal Initial or Prolonged Condition Aggravated Professional (Risperidone) Dehydration Tablets PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Zyprexa (Tablets) Olanzapine C Progesterone (Cream) Progesterone C 22-Feb-2006 08:20 AM Page: 1719 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/03ISR Number: 4186083-5Report Type:Periodic Company Report #NSADSS2003009049 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, ORAL; 0.5 MG, 2 IN 1 DAY, ORAL Zitromax (Azithromycin) C Vasotec (Enalapril Maleate) C Celexa (Citalopram Hydrobromide) C Proventil (Salbutamol) C Atrovent (Ipatropium Bromide) C Date:07/31/03ISR Number: 4186086-0Report Type:Periodic Company Report #NSADSS2003008045 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Risperdal (Risperidone) Tablets PS ORAL ORAL Date:07/31/03ISR Number: 4186092-6Report Type:Periodic Company Report #NSADSS2003006743 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 2 MG, 1 IN 24 HOUR, ORAL Date:07/31/03ISR Number: 4186095-1Report Type:Periodic Company Report #NSADSS2003006519 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Health Risperdal Professional (Risperidone) Company Tablets PS ORAL 0.25 MG, 2 IN Representative DAY, ORAL Tegretol (Unspecified) Carbamazepine C Date:07/31/03ISR Number: 4191544-9Report Type:Periodic Company Report #NSADSS2003023733 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Risperdal Initial or Prolonged Professional (Risperidone) Other Tablets PS ORAL 0.75 MG, 1 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1720 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/31/03ISR Number: 4191546-2Report Type:Periodic Company Report #NSADSS2003023732 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, 2 IN DAY, ORAL Date:07/31/03ISR Number: 4191548-6Report Type:Periodic Company Report #NSADSS2003023494 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal Professional (Risperidone) Tablets PS ORAL 4 MG, 1 IN DAY, ORAL Depakote (Valproate Semisodium) C Klonopin (Clonazepam) C Cogentin (Benzatropine Mesilate) C Date:07/31/03ISR Number: 4191550-4Report Type:Periodic Company Report #NSADSS2003023431 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Embolism Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL Date:07/31/03ISR Number: 4191552-8Report Type:Periodic Company Report #NSADSS2003023222 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Consumer Risperdal Initial or Prolonged (Risperidone) Tablets PS ORAL 0.25 MG, 1 IN 1 DAY, ORAL Date:07/31/03ISR Number: 4191554-1Report Type:Periodic Company Report #NSADSS2003022721 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal Professional (Risperidone) Company Unspecified PS ORAL Representative Date:07/31/03ISR Number: 4191556-5Report Type:Periodic Company Report #NSADSS2003022591 Age:50 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Depression 22-Feb-2006 08:20 AM Page: 1721 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lethargy Suicide Attempt Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal (Risperidone) Tablets PS ORAL 0.5 MG, 2 IN DAY, ORAL Topamax (Tablets) Topiramate C Ambien (Tablets) Zolpidem Tartrate C Stattera (All Other Therapeutic Products) C Date:07/31/03ISR Number: 4191558-9Report Type:Periodic Company Report #NSADSS2003022565 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Risperdal Initial or Prolonged Professional (Risperidone) Tablets PS ORAL 1 MG, ORAL Risperdal (Risperidone) SS 2.5 MG DAILY Zoloft (Sertraline Hydrochloride) C Trazodone (Trazodone) C Date:07/31/03ISR Number: 4191560-7Report Type:Periodic Company Report #NSADSS2003022542 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Risperdal Initial or Prolonged Professional (Risperidone) Unspecified PS Date:07/31/03ISR Number: 4191563-2Report Type:Periodic Company Report #NSADSS2003022362 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Risperdal (Risperidone) Unspecified PS Date:08/01/03ISR Number: 4160237-6Report Type:Direct Company Report #CTU 199059 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Wellbutrin Sr 100 Mg PS ORAL ONE QAM ORAL Risperdal 2 Mg Janssen SS Janssen ORAL ONE BID ORAL Benadryl C 22-Feb-2006 08:20 AM Page: 1722 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/03ISR Number: 4162409-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030705314 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Foreign Risperdal Initial or Prolonged Drooling Health (Risperidone) Fall Professional Solution PS SEE IMAGE Musculoskeletal Stiffness Lorazepam (Lorazepam) C Zopiclone (Zopiclone) C Date:08/01/03ISR Number: 4163080-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030706710 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 3 MG, 2 IN 1 DAY, ORAL Date:08/01/03ISR Number: 4163081-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030706303 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 4 MG, 1 IN 1 DAY, ORAL Date:08/01/03ISR Number: 4163082-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030706732 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL 6 MG, 1 IN 1 DAY, ORAL Aricept (Donepezil Hydrochloride) C Mavik (Trandolapril) C Vitamin B C Tylenol (Paracetamol) C Milk Of Magnesia (Magnesium Hydroxide) C Ativan (Lorazepam) C Date:08/01/03ISR Number: 4163083-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030706299 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Risperdal Professional (Risperidone) Tablets PS ORAL 3 MG, 1 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1723 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/03ISR Number: 4160696-9Report Type:Direct Company Report #CTU 199192 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chills Zyprexa PS ORAL ORAL Hospitalization - Feeling Cold Risperdal SS ORAL ORAL Initial or Prolonged Glasgow Coma Scale Required Abnormal Intervention to Neuroleptic Malignant Prevent Permanent Syndrome Impairment/Damage Oxygen Saturation Decreased Pneumonia Aspiration Respiratory Arrest Vomiting Date:08/04/03ISR Number: 4160760-4Report Type:Direct Company Report #CTU 199140 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Risperdal 4 PS Aggression Strattera 25 SS Bipolar Disorder Condition Aggravated Educational Problem Impulsive Behaviour Judgement Impaired Mental Disorder Psychomotor Hyperactivity Date:08/04/03ISR Number: 4160767-7Report Type:Direct Company Report #CTU 199143 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Behaviour Lithobid 900-900 PS Anger Risperdal SS Drug Ineffective Adderall SS Dysthymic Disorder Depakote 1000 SS Emotional Disorder Strattera 80 SS Negativism Thinking Abnormal Date:08/04/03ISR Number: 4161002-6Report Type:Direct Company Report #CTU 199128 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anxiety Prozac 20 PS Mood Altered Risperdal 0.75 SS Polyuria Strattera 25 SS Post-Traumatic Stress Disorder Date:08/04/03ISR Number: 4161010-5Report Type:Direct Company Report #CTU 199130 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Stereotypic Movement Risperdal PS Disorder Adderall Xr 30 SS 22-Feb-2006 08:20 AM Page: 1724 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/03ISR Number: 4161012-9Report Type:Direct Company Report #CTU 199131 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Affective Disorder Risperdal PS 0.5 Bipolar Disorder Strattera 40 SS 40 Flat Affect Mood Altered Staring Date:08/04/03ISR Number: 4161018-XReport Type:Direct Company Report #CTU 199134 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Mood Altered Lithium PS 300 - 450 Nortriptylene SS 75 Temazepam SS 30 Risperdal SS 2 Strattera SS 40 Date:08/04/03ISR Number: 4161020-8Report Type:Direct Company Report #CTU 199135 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Increased Appetite Lithium PS 300-300 Obesity Risperdal SS 2 Speech Disorder Ddavp SS 0.8 Tongue Disorder Strattera SS 40 Date:08/04/03ISR Number: 4161034-8Report Type:Direct Company Report #CTU 199119 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Lamcital 150 PS Drug Effect Decreased Risperdal 1 SS Dysthymic Disorder Strattera 40 SS Screaming Date:08/04/03ISR Number: 4161587-XReport Type:Direct Company Report #CTU 199277 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Topamax PS ORAL 100MG PO BID Life-Threatening Immeasurable Risperdal SS ORAL 0.5M PO BID Hospitalization - Body Temperature Valproic Acid C Initial or Prolonged Increased ... C Cardio-Respiratory Arrest Dehydration Poor Venous Access Date:08/04/03ISR Number: 4163838-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030706206 Age:37 YR Gender:Male I/FU:I Outcome PT Other Asthenia Body Temperature Increased 22-Feb-2006 08:20 AM Page: 1725 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Convulsion Drug Withdrawal Syndrome Fatigue Report Source Product Role Manufacturer Route Dose Duration Loss Of Consciousness Consumer Duragesic (Fentanyl) Nervousness Patch PS TRANSDERMAL 25; 100; 75; Therapeutic Response 100 UG/HR, 1 Decreased IN 72 HOUR, TRANSDERMAL Risperdal (Risperidone) Tablets SS ORAL 1 IN 1 DAY, ORAL Protonix (Pantoprazole) C Norco (Vicodin) C Prozac (Fluoxetine Hydrochloride) C Date:08/04/03ISR Number: 4163840-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030707356 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS Date:08/04/03ISR Number: 4163861-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030707355 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Health Risperdal Phosphokinase Professional (Risperidone) Blood Sodium Tablets PS ORAL 0.5 MG, 2 IN Cardio-Respiratory Arrest 1 DAY, ORAL Hyperpyrexia Topamax (Topiramate) Loss Of Consciousness Unspecified SS ORAL 100 MG, 2 IN Myoglobin Blood 1 DAY Troponin Valproic Acid (Valproic Acid) SS 125 MG, 8 IN 1 DAY Date:08/04/03ISR Number: 4164212-7Report Type:Expedited (15-DaCompany Report #APCDSS2003000397 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Autoimmune Disorder Foreign Risperidone Hospitalization - Femur Fracture Health (Risperidone) Initial or Prolonged Haemorrhage Professional Tablets PS ORAL 3 MG, 1 IN 1 Oedema Peripheral DAY, ORAL Pneumonia Chlorpromazine Refusal Of Treatment By Hydrochloride Patient (Chlorpromazine Thrombocytopenia Hydrochloride) Tablets SS ORAL 62.5 MG, 1 IN 1 DAY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1726 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pantethine (Pantethine) C Date:08/04/03ISR Number: 4164241-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030705027 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Foreign Risperdal Initial or Prolonged Health (Risperidone) PS ORAL 3 MG, 1 IN 1 Professional DAY, ORAL Eunapan(Melperone) C Date:08/04/03ISR Number: 4164246-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030701228 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal Blood Creatine Health (Risperidone) PS ORAL ORAL Phosphokinase Increased Professional Iron (Iron) C Condition Aggravated Vitamins (Vitamins) C Thrombophlebitis Date:08/04/03ISR Number: 4164288-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030706450 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperlipidaemia Foreign Risperdal Skin Striae Health (Risperidone) Weight Increased Professional Tablets PS ORAL 1 MG, ORAL Date:08/04/03ISR Number: 4164395-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030706425 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal Initial or Prolonged Phosphokinase Health (Risperidone) PS ORAL SEE IMAGE, Bradykinesia Professional ORAL Citalopram (Citalopram) C Insulin (Insulin) C Zopiclone (Zopiclone) C Date:08/05/03ISR Number: 4165506-1Report Type:Expedited (15-DaCompany Report #2003028963 Age:45 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abdominal Discomfort Initial or Prolonged Alanine Aminotransferase Aspartate Aminotransferase Blood Bilirubin Blood Glucose Increased Blood Lactate Dehydrogenase Blood Triglycerides 22-Feb-2006 08:20 AM Page: 1727 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Blood Urea Increased C-Reactive Protein Drug Eruption Report Source Product Role Manufacturer Route Dose Duration Gamma-Glutamyltransferase Foreign Lipitor Haemoglobin Health (Atorvastatin) PS ORAL 10 MG Hepatic Function Abnormal Professional (DAILY), ORAL Hypersensitivity Risperidone Infection (Risperidone) SS ORAL 4 MG (DAILY), Insomnia ORAL Liver Disorder Olanzapine Platelet Count (Olanzapine) SS ORAL 10 MG Pyrexia (DAILY), ORAL Rash Vegetamin A White Blood Cell Count (Phenobarbital, Promethazine, Chlorpromazine Hydrochloride) SS ORAL 12.5 MG/12.5 MG/30 MG (DAILY), ORAL Vegetamin A (Phenobarbital, Promethazine, Chlorpromazine Hydrochloride) SS ORAL 25 MG/12.5 MG/40 MG (DAILY), ORAL Allopurinol (Allopurinol) SS ORAL 100 MG (DAILY), ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Cloxazolam (Cloxazolam) C Date:08/06/03ISR Number: 4163442-8Report Type:Direct Company Report #CTU 199431 Age:7 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Risperidone 1mg PS ORAL 0.5MG QD Condition Aggravated ORAL Date:08/06/03ISR Number: 4164658-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030800309 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Risperidone Exposure To Therapeutic Health (Risperidone) Drugs Professional Solution PS Maternal Drugs Affecting Foetus Premature Separation Of Placenta 22-Feb-2006 08:20 AM Page: 1728 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/07/03ISR Number: 4164297-8Report Type:Direct Company Report #CTU 199557 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Risperidone 3 Mg PS ORAL 3 MG TWICE Initial or Prolonged Chest Pain A DAY ORAL Dizziness Sertraline C Electrocardiogram Qt Methadone C Prolonged Terazosin C Loss Of Consciousness Date:08/07/03ISR Number: 4166943-1Report Type:Expedited (15-DaCompany Report #2003GB02072 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Foreign Seroquel PS Initial or Prolonged Health Risperdal SS Professional Other Date:08/07/03ISR Number: 4167287-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030800611 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Health Risperdal Electrocardiogram Qt Professional (Risperidone) Prolonged Unspecified PS ORAL 3 MG, 1 IN 1 Sudden Death DAY, ORAL Date:08/07/03ISR Number: 4167288-6Report Type:Expedited (15-DaCompany Report #NSADSS2003021743 Age:81 YR Gender:Female I/FU:I Outcome PT Other Asthenia Atrial Fibrillation Blood Chloride Blood Creatine Phosphokinase Blood Creatinine Blood Glucose Blood Potassium Blood Sodium Blood Urea Cardioactive Drug Level Above Therapeutic Cerebrovascular Accident Dehydration Drug Toxicity Dyspnoea Fall Haematocrit Haemoglobin Injury Lacunar Infarction Orthostatic Hypotension Palpitations Pco2 Platelet Count Pneumonia 22-Feb-2006 08:20 AM Page: 1729 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Skin Laceration Troponin White Blood Cell Count Report Source Product Role Manufacturer Route Dose Duration Risperdal (Risperidone) Tablets PS ORAL SEE IMAGE Aspirin (Acetylsalicylic Acid) C Diltiazem (Diltiazem) C Date:08/08/03ISR Number: 4167533-7Report Type:Expedited (15-DaCompany Report #M0798-2003 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Glasgow Coma Scale Health Mirtazapine PS DF Initial or Prolonged Abnormal Professional Risperidone SS DF Hypotension Venlafaxine SS DF Radicular Syndrome Olanzapine SS Somnolence Lormetazepam C Suicide Attempt Prothipendyl Tachycardia Hydrochloride C Date:08/09/03ISR Number: 4166473-7Report Type:Expedited (15-DaCompany Report #NSADSS2003015591 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Risperdal (Risperidone) Tablets PS 0.5 MG IN AM/ 1.5MG AT BEDTIME Xanax (Alprazolam) C Date:08/09/03ISR Number: 4166513-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030800612 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Risperdal Ventricular Fibrillation Professional (Risperidone) Unspecified PS 2 MG, 2 IN 1 DAY Depakote (Valproate Semisodium) SS 250 MG, 2 IN 1 DAY Date:08/09/03ISR Number: 4166516-0Report Type:Expedited (15-DaCompany Report #NSADSS2001021823 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anoxic Encephalopathy Health Risperdall Hospitalization - Fall Professional (Risperidone) Initial or Prolonged Respiratory Failure Tablets PS ORAL 2 MG, ORAL Effexor (Venlafaxine Hydrochloride) C Cogentin 22-Feb-2006 08:20 AM Page: 1730 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Benzatropine Mesilate) C Lorazepam (Lorazepam) C Date:08/09/03ISR Number: 4166706-7Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20030707073 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Risperdal Enzyme Abnormality Health (Risperidone) PS ORAL 0.5 MG, ORAL Hyperthermia Malignant Professional Topamax (Topiramate) SS ORAL 200 MG, ORAL Loss Of Consciousness Date:08/09/03ISR Number: 4166709-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030707392 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Loss Of Consciousness Foreign Risperidone Road Traffic Accident Health (Risperidone) PS Professional Date:08/09/03ISR Number: 4166715-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030707415 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal Initial or Prolonged Dyspnoea Health (Risperidone) PS ORAL 5 MG, 1 IN 1 Dystonia Professional DAY, ORAL; Iiird Nerve Disorder ORAL Muscle Contracture Oxygen Saturation Decreased Swollen Tongue Tachycardia Trismus Date:08/09/03ISR Number: 4166717-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030707421 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Chronic Foreign Risperdal Condition Aggravated Health (Risperidone) PS ORAL 1 MG, ORAL Professional Date:08/09/03ISR Number: 4167378-8Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20030707073 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Foreign Risperdal Enzyme Abnormality Health (Risperidone) Hyperthermia Malignant Professional Unspecified PS ORAL 0.5 MG, ORAL Loss Of Consciousness Topamax (Topiramate) Unspecified SS ORAL 200 MG, ORAL 22-Feb-2006 08:20 AM Page: 1731 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/03ISR Number: 4167379-XReport Type:Expedited (15-DaCompany Report #GB-JNJF0C-20030705120 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Foreign Risperdal Initial or Prolonged Gait Disturbance Health (Risperidone) Hypertonia Professional Unspecified PS ORAL 0.5 MG, ORAL; Muscle Rigidity 1.5 MG, 2 IN Somnolence 1 DAY, ORAL Zopiclone C Sertraline C Lorazepam C Date:08/09/03ISR Number: 4167380-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030705674 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adverse Event Foreign Risperdal Initial or Prolonged Health (Risperidone) Professional Unspecified PS Melperon (Melperone) C Date:08/11/03ISR Number: 4167598-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030800309 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Risperidone Hospitalization - Caesarean Section Health (Risperidone) Initial or Prolonged Complications Of Maternal Professional Tablets PS ORAL 2 MG, 1 IN 1 Other Exposure To Therapeutic DAY, ORAL Drugs Trihexyphenidyl Maternal Drugs Affecting Hydrochloride Foetus (Trihexyphenidyl Pregnancy Hydrochloride) Premature Separation Of Tablets C Placenta Date:08/11/03ISR Number: 4167600-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030800075 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other General Physical Health Foreign Risperdal Deterioration Health (Risperidone) Sedation Professional Tablets PS ORAL ORAL Madopar (Madopar) Tablets SS ORAL 125 MG, 3 IN 1 DAY, ORAL Madopar Retarded Formula (Madopar) SS 2 MG, 1 IN 1 DAY Date:08/11/03ISR Number: 4167892-5Report Type:Expedited (15-DaCompany Report #APCDSS2003000151 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperprolactinaemia Foreign Risperidone Initial or Prolonged Ileus Health (Risperidone) Professional Tablets PS ORAL 4 MG, 1 IN 1 22-Feb-2006 08:20 AM Page: 1732 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Candesartan Cilexetil (Candesartan Cilexetil) C Senna Extract (Senna Liquid Extract) C Haloperidol (Haloperidol) C Levomepromazine Maleate (Levomepromazine Maleate) C Date:08/11/03ISR Number: 4167894-9Report Type:Expedited (15-DaCompany Report #EMADSS2002006527 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Risperidone Initial or Prolonged Exposure To Therapeutic Health (Risperidone) Drugs Professional Tablets PS ORAL 1 MG, 1 IN 1 Depression DAY, ORAL Haemorrhage Zoloft Sertraline Hypertension Hydrochloride C Stilnox (Zolpidem) C Date:08/11/03ISR Number: 4168327-9Report Type:Expedited (15-DaCompany Report #NSADSS2003019994 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal Respiratory Failure Professional (Risperidone) Unspecified PS LOW DOSE Date:08/11/03ISR Number: 4168335-8Report Type:Expedited (15-DaCompany Report #NSADSS2003020307 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Alkaline Health Risperdal Phosphatase Increased Professional (Risperidone) Blood Cholesterol Tablets PS 0.5-0.75MG Increased DAILY Coeliac Disease Hypertriglyceridaemia Pancreatitis Date:08/11/03ISR Number: 4168345-0Report Type:Expedited (15-DaCompany Report #NSADSS2002014974 Age:47 YR Gender:Female I/FU:F Outcome PT Other Blood Prolactin Increased Breast Cancer Menstruation Irregular Metrorrhagia 22-Feb-2006 08:20 AM Page: 1733 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pituitary Tumour Benign Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL ORAL Prozac (Fluoxetine Hydrochloride) C Buspirone C Asacol (Mesalazine) C Azathioprine C Date:08/12/03ISR Number: 4166974-1Report Type:Direct Company Report #CTU 199888 Age:35.5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Risperdal/Risperidon Life-Threatening Circulatory Collapse e "Virus" "Flu" Etc PS 1ST TIME Hospitalization - Drug Toxicity GIVEN LIQUID Initial or Prolonged Dysgeusia RISPERDAL Disability FROM USUAL Other PILLS Required Intervention to Prevent Permanent Impairment/Damage Date:08/12/03ISR Number: 4168466-2Report Type:Expedited (15-DaCompany Report #2003032704 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Foreign Sertraline Syndrome Health (Sertraline) PS ORAL (DAILY), ORAL Professional Risperidone (Risperidone) SS ORAL ORAL Mesalazine (Mesalazine) C Procyclidine (Procyclidine) C Prednisolone (Prednisolone) C Melatonin (Melatonin) C Date:08/12/03ISR Number: 4168719-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030800198 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1734 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/03ISR Number: 4168957-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030706419 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Risperdal Initial or Prolonged Endocarditis Health (Risperidone) Other Extrapyramidal Disorder Professional Tablets PS ORAL ORAL Myoglobinuria Zyprexia Pancytopenia (Olanzapine) Tablets SS ORAL 15 MG, ORAL Psychotic Disorder Haldol (Haloperidol) Pyrexia Unspecified SS 2 MG, 3 IN 1 Rhabdomyolysis DAY Belok Zok (Metoprolol Succinate) SS 95 MG, 1 IN 1 DAY Norvasc (Amlodipine Besilate) SS ORAL 5 MG, 2 IN 1 DAY, ORAL Xanef (Enalapril Maleate) Tablets SS ORAL ORAL Tavor (Lorazepam) SS ORAL 0.5 MG, 3 IN 1 DAY, ORAL Vibolex (B-Komplex "Leciva") Capsules SS ORAL 300 MG, 2 IN 1 DAY, ORAL Hydrochlorothiazide C Molsidomin (Molsidomine) C Kalinor (Potassium Chloride) C Dytide H (Dyazide) C Kepinol (Bactrim) C Corvaton Ret. (Molsidomine) C Date:08/12/03ISR Number: 4168964-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030706419 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Risperdal Initial or Prolonged Drug Interaction Health (Risperidone) Other Endocarditis Professional Tablets PS ORAL ORAL Extrapyramidal Disorder Zyprexia General Physical Health (Olanzapine) Tablets SS ORAL 15 MG, ORAL Deterioration Haldol (Haloperidol) SS 2 MG, 3 IN 1 Pancytopenia DAY Rhabdomyolysis Belok Zok (Metoprolol Succinate) SS 95 MG, 1 IN 1 DAY Norvasc (Amlodipine Besilate) SS ORAL 5 MG, 2 IN 1 DAY, ORAL Xanef (Enalapril Maleate) Tablets SS ORAL ORAL Tavor (Lorazepam) SS ORAL 0.5 MG, 3 IN 1 DAY, ORAL Vibolex (B-Komplex "Leciva") Capsules SS ORAL 300 MG, 2 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1735 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochlorothiazide (Hydrochlorothiazide ) C Molsidomin (Molsidomine) C Kalinor (Potassium Chloride) C Dytide H (Dyazide) Tablets C Kepinol (Bactrim) C Corvaton Ret. (Molsidomine) Tablets C Date:08/13/03ISR Number: 4170411-0Report Type:Expedited (15-DaCompany Report #BR-JNJFOC-2003802292 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Foreign Haldol (Haloperidol) Initial or Prolonged Health Unspecified PS Professional Risperidone (Risperidone) Unspecified SS Orap (Pimozide) Unspecified SS Anafranil (Clomipramine Hydrochloride) SS Date:08/14/03ISR Number: 4168747-2Report Type:Direct Company Report #USP 50005 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Risperdal PS Janssen Pharm TAB Propulsid SS Janssen Pharm TAB Date:08/14/03ISR Number: 4170309-8Report Type:Expedited (15-DaCompany Report #BR-JNJFOC-20030802289 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Foreign Haldol (Haloperidol) Initial or Prolonged Health Unspecified PS Professional Risperdal (Risperidone) Unspecified SS Rivotril (Clonazepam) SS Tofranil (Imipramine Hydrochloride) SS Date:08/14/03ISR Number: 4170482-1Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20030707073 Age:47 YR Gender:Female I/FU:F Outcome PT Life-Threatening Blood Creatine Phosphokinase Increased Coma 22-Feb-2006 08:20 AM Page: 1736 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hyperthermia Malignant Loss Of Consciousness Myoglobin Blood Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 0.5 MG , ORAL Topamax (Topiramate) Unspecified SS ORAL 200 MG, ORAL Date:08/14/03ISR Number: 4170486-9Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20030707073 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Risperdal Phosphokinase Increased Health (Risperidone) Coma Professional Unspecified PS ORAL 0.5 MG, ORAL Hyperthermia Malignant Topamax (Topiramate) Loss Of Consciousness Unspecified SS ORAL 200 MG, ORAL Myoglobin Blood Increased Date:08/14/03ISR Number: 4170497-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030801855 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 4 MG, 1 IN 1 DAY, ORAL Date:08/14/03ISR Number: 4170543-7Report Type:Expedited (15-DaCompany Report #BR-JNJFOC-20030802292 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Foreign Haldol (Haloperidol) Initial or Prolonged Health Unspecified PS Professional Risperidone (Risperidone) Unspecified SS Orap (Pimozide) Unspecified SS Anafranil (Clomipramine Hydrochloride) SS Date:08/15/03ISR Number: 4171582-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030800845 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1737 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/03ISR Number: 4171584-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030801161 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL Date:08/15/03ISR Number: 4171586-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030802013 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Liver Disorder Health Risperdal Professional (Risperidone) PS Date:08/15/03ISR Number: 4171660-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030705737 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Risperdal Initial or Prolonged Accidental Overdose Consumer (Risperidone) Blood Pressure Health Unspecified PS ORAL SEE IMAGE Convulsion Professional Depoprovera Enuresis (Medroxyprogesterone Faecal Incontinence Acetate) C Heart Rate Increased Melatonin Medication Error (Melatonin) C Respiratory Rate Increased Date:08/15/03ISR Number: 4171661-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030706450 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperlipidaemia Foreign Risperdal Skin Striae Health (Risperidone) Weight Increased Professional Tablets PS ORAL 1 MG, ORAL Date:08/15/03ISR Number: 4171662-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030800651 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Risperdal Initial or Prolonged Epilepsy Consumer (Risperidone) Disability Headache Health Tablets PS ORAL 2 MG , 1 IN 1 Joint Sprain Professional DAY, ORAL Lordosis Tegretol Myalgia (Carbamazepine) C Neck Pain Neurontin Paraesthesia (Gabapentin) C Road Traffic Accident Rivotril (Clonzepam) C Spinal Disorder Prozac (Fluoxetine Torticollis Hydrochloride) C Vertigo Vectarion (Almitrine Vomiting Dimesilate) C Seretide (Seretide) C Bronchodual (Duovent) C 22-Feb-2006 08:20 AM Page: 1738 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Artane (Trihexyphenidyl Hydrochloride) C Singulair (Montelukast Sodium) C Lasilix (Furosemide) C Date:08/15/03ISR Number: 4171663-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030800660 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 1 MG, ORAL Date:08/15/03ISR Number: 4171665-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030801850 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Risperdal Initial or Prolonged Hallucinations, Mixed Health (Risperidone) Professional Tablets PS ORAL 0.25 MG, 1 IN 1 DAY, ORAL Piracetam (Piracetam) C Dimazol (Dimazole) C Digitoxin (Digitoxin) C Torem (Torasemide) C Belok Zok (Metoprolol Succinate) C Date:08/15/03ISR Number: 4171709-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030705652 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Somnolence Foreign Risperidone Thrombocytopenia Health (Risperidone) Professional Solution PS ORAL 0.5 M1, 1 IN 1 DAY, ORAL;0.2 M1, 1 IN 1 DAY, ORAL Imipenem Cilastatin Sodium (Imipenem) Injection SS Nitrazepam (Nitrazepam) C Date:08/18/03ISR Number: 4172425-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030801768 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glaucoma Health Risperdal Professional (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1739 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/03ISR Number: 4172426-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030801766 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glaucoma Consumer Risperdal Retinal Detachment (Risperidone) Tablets PS ORAL 4 MG, 2 IN 1 DAY, ORAL Date:08/18/03ISR Number: 4172427-7Report Type:Expedited (15-DaCompany Report #NSADSS2002034941 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Ativan (Lorazepam) C Dicyclomine (Dicycloverine Hydrochloride) C Viox (Rofecoxib) C Ultram (Tramadol Hydrochloride) C Prinivil (Lisinopril) C Premarin (Estrogens Conjugated) C Neurontin (Gabapentin) C Lortab (Vicodin) C Date:08/18/03ISR Number: 4172428-9Report Type:Expedited (15-DaCompany Report #NSADSS2003000895 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 3 MG, 1 IN 1 DAY, ORAL Vitamin B12 (Cyanocobalamin) C Date:08/18/03ISR Number: 4172429-0Report Type:Expedited (15-DaCompany Report #NSADSS2002038666 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Health Risperdal Other Leukopenia Professional (Risperidone) Tablets PS ORAL ORAL Polypharmacy (All Other Therapeutic Products) C 22-Feb-2006 08:20 AM Page: 1740 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/03ISR Number: 4173021-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030800309 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Discomfort Foreign Risperidone Hospitalization - Anaemia Health (Risperidone) Initial or Prolonged Caesarean Section Professional Tablets PS ORAL 2 MG, 1 IN 1 Other Haemoglobin DAY, ORAL Haemoglobin Decreased Trihexyphenidyl Pregnancy Hydrochloride Premature Separation Of (Trihexyphenidyl Placenta Hydrochloride) C Date:08/18/03ISR Number: 4173067-6Report Type:Expedited (15-DaCompany Report #EMADSS2003004284 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperdal Initial or Prolonged General Nutrition Health (Risperidone) PS ORAL 4 MG, ORAL Other Disorder Professional Lyogen (Injection) Hepatic Cirrhosis Fluphenzine C Hepatic Steatosis Cipramil (Citalopram Liver Function Test Hydrobromide) C Abnormal Psychotic Disorder Date:08/18/03ISR Number: 4173068-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030801932 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Leukopenia Health (Risperidone) Thrombocytopenia Professional Tablets PS ORAL ORAL Clozapine (Clozapine) SS Date:08/18/03ISR Number: 4173069-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030706395 Age:32 YR Gender:Male I/FU:I Outcome PT Life-Threatening Abdominal Distension Hospitalization - Blood Potassium Increased Initial or Prolonged Blood Pressure Immeasurable Depressed Level Of Consciousness Diabetic Ketoacidosis Dyspnoea Glycosylated Haemoglobin Increased Haemodialysis Hallucination, Auditory Hyperglycaemia Insomnia Pancreatitis Acute Renal Failure Acute Respiratory Disorder Restlessness Rhabdomyolysis 22-Feb-2006 08:20 AM Page: 1741 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Toothache Weight Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Risperidone Health (Risperidone) Professional Tablets PS ORAL SEE IMAGE Perospirone Hydrochloride Hydrate (All Other Therapeutic Products) Tablets SS ORAL 8 MG, 1 IN 1 DAY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride)Tablet s SS ORAL 2 MG, 1 IN 1 DAY, ORAL Levomepromazine Maleate (Levomepromazine Maleate) Tablets SS ORAL 5 MG, 1 IN 1 DAY, ORAL Flunitrazepam (Flunitrazepam) Tablets SS ORAL 2 MG, 1 IN 1 DAY, ORAL Date:08/18/03ISR Number: 4173070-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030707392 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Loss Of Consciousness Foreign Risperidone Road Traffic Accident Health (Risperidone) Professional Tablets PS ORAL 8 MG, 1 IN 1 DAY, ORAL Sennoside (Tablets) Therapeutic Products C Sodium Picosulfate (Tablets) Sodium Picosulfate C Flunitrazepam (Flunitrazepam) Tablets C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:08/18/03ISR Number: 4173247-XReport Type:Expedited (15-DaCompany Report #FRWYE244707AUG03 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Seresta (Oxazepam, Initial or Prolonged Coma Health Capsule, 0) PS ORAL ORAL Other Medication Error Professional Risperdal Pyrexia Other (Risperidone, ,0) SS ORAL ORAL Theralene (Alimemazine 22-Feb-2006 08:20 AM Page: 1742 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tartrate, ,0) SS ORAL ORAL Date:08/19/03ISR Number: 4174471-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030801869 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiogenic Shock Foreign Risperdal Initial or Prolonged Pulmonary Oedema Health (Risperidone) Rhabdomyolysis Professional Unspecified PS ORAL 3 MG, 1 IN 1 DAY, ORAL Truxal Chlorprothixene Hydrochloride C Date:08/20/03ISR Number: 4172728-2Report Type:Direct Company Report #CTU 200380 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cerebrovascular Accident Risperidone PS 1 MG HS 1 YR Date:08/20/03ISR Number: 4172888-3Report Type:Direct Company Report #CTU 200340 Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Somnolence Risperdal, 0.5 Mg PS 0.5 MG , 1/2 BEFORE BEDTIME 1 YR Lanoxin SS ONE, 125 MCG [MANY YEARS] Date:08/20/03ISR Number: 4172975-XReport Type:Direct Company Report #CTU 200337 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erectile Dysfunction Risperdal 3 Mg PS ORAL 1 1/2 (3 MG) Initial or Prolonged Painful Erection =4.5MG ORAL 8 YR Required Intervention to Prevent Permanent Impairment/Damage Date:08/20/03ISR Number: 4175012-6Report Type:Expedited (15-DaCompany Report #NSADSS2002034115 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hemiparesis Consumer Risperdal Transient Ischaemic Health (Risperidone)Tablets PS ORAL ORAL Attack Professional Creon (Pancreatin) C Neurontin (Gabapentin) C Glucovance (Glibomet) C Synthroid (Levothyroxine Sodium) C Effexor (Venlafaxine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1743 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Reminyl (Galantamine) C Date:08/20/03ISR Number: 4175349-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030803145 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Posture Abnormal Foreign Risperidone Initial or Prolonged Health (Risperidone) Professional Unspecified PS ORAL 6 MG, 1 IN 1 DAY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Estazolam (Estazolam) C Date:08/20/03ISR Number: 4175350-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030803618 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glaucoma Foreign Risperidone Tardive Dyskinesia Consumer (Risperidone) Unspecified PS Date:08/21/03ISR Number: 4175875-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030800651 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Risperdal Initial or Prolonged Epilepsy Consumer (Risperidone) Disability Headache Health Tablets PS ORAL 2 MG, 1 IN 1 Joint Sprain Professional DAY, ORAL Lordosis Tegretol Myalgia (Carbamazepine) C Neck Pain Neurontin Paraesthesia (Gabapentin) C Radiculopathy Rivotril Road Traffic Accident (Clonazepam) C Spinal Disorder Prozac (Fluoxetine Torticollis Hydrochloride) C Vertigo Vectarion (Almitrine Vomiting Dimesilate) C Seretide (Seretide) C Bronchodual (Duovent) C Artane (Trihexyphenidyl Hydrochloride) C Singulair (Montelukast Sodium) C Lasilix (Furosemide) C 22-Feb-2006 08:20 AM Page: 1744 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/21/03ISR Number: 4176645-3Report Type:Expedited (15-DaCompany Report #DEWYE253313AUG03 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Trevilor Retard Initial or Prolonged Inadequate Control Professional (Venlafaxine Infection Hydrochloride, Neuroleptic Malignant Capsule, Extended Syndrome Release, 0) PS ORAL 150 MG 1 X White Blood Cell Count PER 1 DAY, Increased ORAL Risperdal (Risperidone) SS Marcumar (Phenprocoumon) C Zopiclone (Zopiclone) C Dilatrend (Carvedilol) C Spironolactone (Spironolactone) C Digoxin (Digoxin) C Levothyroxine (Levothyroxine) C Date:08/21/03ISR Number: 4176888-9Report Type:Expedited (15-DaCompany Report #S03-USA-03512-01 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Lexapro Depression Professional (Escitalopram) PS ORAL 10 MG QD PO Company Lexapro Representative (Escitalopram) SS ORAL 10 MG QD PO Lexapro (Escitalopram) SS ORAL 5 MG QD PO Risperdal (Risperidone) SS 1 MG TID Risperdal (Risperidone) SS 1 MG BID Trileptal SS 300 MG QAM Trileptal SS 600 MG QHS Date:08/21/03ISR Number: 4197263-7Report Type:Periodic Company Report #2002002587 Age:68 YR Gender:Male I/FU:I Outcome PT Hospitalization - Balance Disorder Initial or Prolonged Blood Pressure Fluctuation Coordination Abnormal Depression Difficulty In Walking Dyskinesia Feeling Hot Flat Affect Headache Hypotension Insomnia Lacrimation Increased Ocular Hyperaemia 22-Feb-2006 08:20 AM Page: 1745 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tinnitus Report Source Product Role Manufacturer Route Dose Duration Consumer Norvasc (Amlodipine) PS ORAL 5 MG (QD), ORAL Adenoside (Adenosine) SS Imdur (Isosorbide Mononitrate) SS ORAL 30 MG, ORAL Risperdal (Risperidone) SS ORAL ORAL Furosemide (Furosemide) C Tamsulosin Hydrochloride (Tamsulosin Hydrochloride) C Date:08/22/03ISR Number: 4173313-9Report Type:Direct Company Report #CTU 200461 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Clozapine 100 Mg Intervention to Diabetes Mellitus Tablet, Ivax PS Ivax ORAL 100 MG BID PO Prevent Permanent (INCREASED Impairment/Damage TITRATION) Risperdal 3mg Or 2mg Tablet, Janssen SS Janssen 3MG BID PO THEN 2MG BID PO Ativan C Risperdal M C Tylenol C Glucotrol Xl C Glucophage C Maalox C Milk Of Magnesia C Date:08/22/03ISR Number: 4173432-7Report Type:Direct Company Report #CTU 200480 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hemiparesis Risperdal 1 Mg PS ORAL 1 MG PO Q HS Hospitalization - Initial or Prolonged Date:08/22/03ISR Number: 4176286-8Report Type:Expedited (15-DaCompany Report #2003029529 Age:8 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Zoloft (Oral Conc) Initial or Prolonged Aggression Professional (Sertraline) PS ORAL 60 MG Other Anxiety (DAILY), ORAL Drug Withdrawal Syndrome Risperidone Dyskinesia (Risperidone) SS ORAL 3 MG (TID), Movement Disorder ORAL Weight Decreased Benzatropine Mesilate 22-Feb-2006 08:20 AM Page: 1746 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Benzatropine Mesilate) SS Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) C Date:08/22/03ISR Number: 4176385-0Report Type:Expedited (15-DaCompany Report #NSADSS2002046625 Age:90 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Health Risperdal Agitation Professional (Risperidone) Confusional State Unspecified PS ORAL SEE IMAGE Diabetes Mellitus Aricept (Donepezil Excoriation Hydrochloride) C Faecal Incontinence Hytrin (Terazosin Fall Hydrochloride) C Skin Laceration Prozac (Fluoxetine Subdural Haematoma Hydrochloride) C Urinary Incontinence Glucotrol Xl (Glipizide) C Date:08/22/03ISR Number: 4176386-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030802489 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS Date:08/22/03ISR Number: 4176387-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030802488 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:08/22/03ISR Number: 4176388-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030802487 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:08/22/03ISR Number: 4176389-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030802486 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Infection Health Risperdal Hospitalization - Professional (Risperidone) Initial or Prolonged Tablets PS ORAL 3 MG, 1 IN 1 DAY, ORAL Paxil (Paroxetine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1747 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium (Lithium) C Date:08/22/03ISR Number: 4176391-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030802485 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:08/22/03ISR Number: 4176392-8Report Type:Expedited (15-DaCompany Report #US - JNJFOC - 20030802482 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL 2 MG, 3 IN 1 DAY, ORAL Date:08/22/03ISR Number: 4176393-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030802483 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Consumer Risperdal Hospitalization - (Risperidone) Initial or Prolonged Tablets PS ORAL ORAL Reminyl (Galantamine) Tablets SS ORAL ORAL Date:08/22/03ISR Number: 4176394-1Report Type:Expedited (15-DaCompany Report #NSADSS2002046469 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Sepsis Health Risperdal Intestinal Obstruction Professional (Risperidone) Tablets PS ORAL 1 MG, 1 IN 24 HOUR, ORAL Imdur (Tablets) Isosorbide Mononitrate C Pancrease (Unspecified) Pancrelipase C Insulin (Insulin) Injection C Prevacid (Lansoprazole) Capsules C Date:08/22/03ISR Number: 4177497-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030800651 Age:47 YR Gender:Female I/FU:F Outcome PT Hospitalization - Drug Ineffective Initial or Prolonged Epilepsy 22-Feb-2006 08:20 AM Page: 1748 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Headache Joint Sprain Lordosis Report Source Product Role Manufacturer Route Dose Duration Myalgia Foreign Risperdal Neck Pain Consumer (Risperidone) Paraesthesia Health Tablets PS ORAL 2 MG, 1 IN 1 Radiculopathy Professional DAY, ORAL Road Traffic Accident Tegretol(Carbamazepi Scan Abnormal ne) C Torticollis Neurontin Vertigo (Gabapentin) C Vomiting Rivotril (Clonazepam) C Prozac (Fluoxetine Hydrochloride) C Vectarion (Almitrne Dimesilate) C Seretide (Seretide) C Bronchodual (Duovent) C Artane (Trihexyphenidyl Hydrochloride) C Singulair (Montelukast Sodium) C Lasilix (Furosemide) C Date:08/22/03ISR Number: 4177517-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030802208 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Corticotrophin Foreign Haldol (Haloperidol) PS Decreased Health Risperdal Blood Prolactin Increased Professional (Risperidone) Prolactinoma Tablets SS ORAL SEE IMAGE Date:08/22/03ISR Number: 4177519-4Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20030801946 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Electrocardiogram Qt Health (Risperidone) PS ORAL 2 MG, ORAL Corrected Interval Professional Dominal Hypokalaemia (Prothipendyl Ventricular Extrasystoles Hydrochloride) SS 40 MG Zestril (Lisinopril) C Amlor (Amlodipine Besilate) C Kalium Durettes (Potassium Chloride) C Date:08/22/03ISR Number: 4177520-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030802503 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Risperidone Initial or Prolonged Bone Marrow Disorder Health (Risperidone) PS ORAL 4 MG, 1 IN 1 Other Feeling Abnormal Professional DAY, ORAL 22-Feb-2006 08:20 AM Page: 1749 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Sulpiride (Sulpiride) C Quetiapine Fumarate (Quetiapine Fumarate) Tablets C Flunitrazepam (Flunitrazepam) C Quazepam (Quazepam) C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Date:08/22/03ISR Number: 4177524-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030802216 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Risperdal Initial or Prolonged Toxicologic Test Abnormal Health (Risperidone) PS ORAL ORAL Professional Valium (Diazepam) C Imovane (Zopiclone) C Date:08/22/03ISR Number: 4177525-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030802208 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Corticotrophin Foreign Haldol (Haloperidol) PS Decreased Health Risperdal Blood Prolactin Increased Professional (Risperidone) Pituitary Tumour Tablets SS ORAL SEE IMAGE Date:08/22/03ISR Number: 4177560-1Report Type:Expedited (15-DaCompany Report #FRWYE256414AUG03 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Study Effexor (Venlafaxine Drug Exposure During Hydrochloride, Pregnancy Tablet) PS ORAL 1 TABLET 1X Foetal Heart Rate PER 1 DAY Abnormal Atarax (Hydroxyzine Hyrochloride, , 0) SS ORAL 1 TABLET 1X PER 1 DAY Lepticur (Tropatepine Hydrochloride, , 0) SS 8 DAY Risperdal (Risperidone, , ) SS ORAL 2 MG 1X PER 1 DAY 8 DAY Seresta (Oxazepam, Tablet) SS ORAL 1 TABLET 1X PER 1 DAY Tercian (Cyamemazine, , 0) SS ORAL 10 DROP 1X PER 1 DAY 15 DAY 22-Feb-2006 08:20 AM Page: 1750 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Theralene (Alimemazine Tartrate, , 0) SS 15 DAY Tranxene (Clorazepate Dipotassium, , 0) SS 15 DAY Date:08/25/03ISR Number: 4172906-2Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041704A Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Paroxetin PS Glaxosmithkline ORAL 20MG Unknown Initial or Prolonged Phosphokinase Increased Risperdal SS ORAL 5MG per day Parkinsonism Suicide Attempt Date:08/25/03ISR Number: 4173833-7Report Type:Direct Company Report #CTU 200564 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Status Changes Haloperidol 0.5mg PS ORAL 0.5 MG HS Initial or Prolonged ORAL Risperidone 1 Mg SS ORAL 1 MG/2 AM/HS ORAL Galantamine C Date:08/25/03ISR Number: 4177877-0Report Type:Expedited (15-DaCompany Report #FRWYE256414AUG03 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Foetal Heart Rate Study Effexor (Venlafaxine Abnormal Hydrochloride, Maternal Drugs Affecting Tablet, 0) PS ORAL 1 TABLET 1X Foetus PER 1 DAY Atarax (Hydroxyzine Hydrochloride) SS ORAL 1 TABLET 1X PER 1 DAY Lepticur (Tropatepine Hydrochloride) SS 8 DAY Risperdal (Risperidone) SS ORAL 2 MG 1X PER 1 DAY 8 DAY Seresta (Oxazepam, Tablet) SS ORAL 1 TABLET 1X PER 1 DAY Tercian (Cyamemazine) SS ORAL 10 DROP 1X PER 1 DAY 15 DAY Theralene (Alimemazine Tartrate) SS 15 DAY Tranxene (Clorazepate Dipotassium) SS 15 DAY 22-Feb-2006 08:20 AM Page: 1751 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/03ISR Number: 4175009-6Report Type:Direct Company Report #CTU 200728 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myoclonus Risperidone PS Initial or Prolonged Serotonin Syndrome Tegretol C Lithium C Date:08/26/03ISR Number: 4178491-3Report Type:Expedited (15-DaCompany Report #FRWYE256414AUG03 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Study Effexor (Venlafaxine Foetal Heart Rate Hydrochloride, Abnormal Tablet, 0) PS ORAL 1 TABLET 1X Maternal Drugs Affecting PER 1 DAY Foetus Atarax (Hydroxyzine Hydrochloride, 0) SS ORAL 1 TABLET 1X PER 1 DAY Lepticur (Tropatepine Hydrochloride, 0) SS Risperdal (Risperidone, , 0) SS ORAL 2 MG 1X PER 1 DAY Seresta (Oxazepam, Tablet) SS ORAL 1 TABLET 1X PER 1 DAY Tercian (Cyamemazine, , 0) SS ORAL 10 DROP 1X PER 1 DAY Theralene (Alimemazine Tartrate, , 0) SS Tranxene (Clorazepate Dipotassium, , 0) SS Date:08/26/03ISR Number: 4178579-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030803401 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Infection Health Risperdal Initial or Prolonged Neutropenia Professional (Risperidone) White Blood Cell Count Tablets PS ORAL 0.25 MG, 2 IN 1 DAY, ORAL Paxil (Paroxetine Hydrochloride) C Xanax (Alprazolam) C Date:08/26/03ISR Number: 4178580-3Report Type:Expedited (15-DaCompany Report #NSADSS2002021975 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Risperdal Depressive Symptom Health (Risperidone) Professional Tablets PS ORAL 2 MG, 2 IN 1 DAY, ORAL Wellbutrin 22-Feb-2006 08:20 AM Page: 1752 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Bupropion Hydrochloride) C Effexor (Venlafaxine Hydrochloride) C Glucophage Xr (Metformin Hydrochloride) C Date:08/26/03ISR Number: 4178582-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030802746 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Unspecified PS UNKNOWN Date:08/26/03ISR Number: 4178583-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030802744 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, 1 IN 1 DAY, ORAL Date:08/26/03ISR Number: 4179540-9Report Type:Expedited (15-DaCompany Report #NZ-JNJFOC-20030801831 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Risperidone Hospitalization - Dementia Health (Risperidone) PS ORAL 0.5 MG, 1 IN Initial or Prolonged Extrapyramidal Disorder Professional 1 DAY, ORAL Gastric Ulcer Haemorrhage Zuclopenthixol Acetate (Zuclopenthixol Acetate) Injection SS INTRAMUSCULAR 200 MG, INTRAMUSCULAR Date:08/26/03ISR Number: 4179542-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030704684 Age:26 YR Gender:Male I/FU:I Outcome PT Death Activated Partial Hospitalization - Thromboplastin Time Initial or Prolonged Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Creatine Phosphokinase Increased Blood Creatinine Increased Blood Glucose Increased Blood Pressure Increased Blood Sodium Increased Body Temperature Decreased 22-Feb-2006 08:20 AM Page: 1753 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Brugada Syndrome Bundle Branch Block Right Cardio-Respiratory Arrest Report Source Product Role Manufacturer Route Dose Duration Coma Foreign Risperdal Electrocardiogram Qrs Health (Risperidone) PS ORAL 4 MG, 3 IN 1 Complex Prolonged Professional DAY, ORAL Electrocardiogram St Diazepam (Diazepam) C Segment Elevation Loxapac (Loxapine Fall Succinate) Injection C Heart Disease Congenital Theralene Heart Rate Increased (Alimenazine Hypokalaemia Tartrate) C Mydriasis Thrombin Time Date:08/26/03ISR Number: 4179543-4Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20030802835 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperidone Health (Risperidone) Professional Tablets PS 6 MG, IN 1 DAY Risperdal Consta (Risperidone) Microspheres SS INTRAMUSCULAR INTRA-MUSCULA R Date:08/26/03ISR Number: 4179545-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030801850 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Risperdal Initial or Prolonged Confusional State Health (Risperidone) Delusion Professional Tablets PS ORAL 0.25 MG, 1 IN Hallucinations, Mixed 1 DAY, ORAL Personality Change Belok Zok Sedation (Metoprolol Suicidal Ideation Succinate) C Thiamazole (Thiamazole) Tablets C Nexium (Esomeprazole) C Date:08/27/03ISR Number: 4176054-7Report Type:Direct Company Report #CTU 200829 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Cogwheel Rigidity Risperidone PS ORAL 4 MG HS PO Masked Facies Date:08/27/03ISR Number: 4176057-2Report Type:Direct Company Report #CTU 200830 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Galactorrhoea Risperidone PS ORAL 4 MG QHS PO 22-Feb-2006 08:20 AM Page: 1754 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/03ISR Number: 4176067-5Report Type:Direct Company Report #CTU 200832 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Discharge Risperidone PS ORAL PO Breast Pain Nipple Disorder Date:08/27/03ISR Number: 4176076-6Report Type:Direct Company Report #CTU 200834 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Prolactin Increased Risperidone PS ORAL 2 MG PO Intervention to Dyskinesia Prevent Permanent Menstrual Disorder Impairment/Damage Tardive Dyskinesia Tic Date:08/27/03ISR Number: 4180587-7Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20030704666 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Foreign Risperdal Distress Syndrome Health (Risperidone) PS ORAL SEE IMAGE Anxiety Professional Largactil Confusional State (Chlorpromazine Depressed Level Of Hydrochloride) SS SEE IMAGE Consciousness Dolcontin (Morphine Leukocytosis Sulfate) C Neuroleptic Malignant Paracet Syndrome (Paracetamol) C Paranoia Clarityn Pneumonia (Loratadine) C Psychotic Disorder Mycostatin Renal Failure (Nystatin) C Sepsis Afipran (Metoclopramide Hydrochloride) C Penicillin (Benzylpenicillin Sodium) C Naxogin (Nimorazole) C Levaxin (Levothyroxine Sodium) C Entocort (Budesonide) C Somac (Pantoprazole Sodium) C Vioxx (Rofecoxib) C Cisplatin (Cisplatin) C Sobril (Oxazepam) C Selexid (Pivmecillinam Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1755 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/03ISR Number: 4180588-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030800309 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaemia Foreign Risperidone Hospitalization - Caesarean Section Health (Risperidone) Initial or Prolonged Complications Of Maternal Professional Tablets PS ORAL 2 MG, 1 IN 1 Other Exposure To Therapeutic DAY, ORAL Drugs Ritodrine Intra-Uterine Death Hydrochloride Maternal Drugs Affecting (Ritodrine Foetus Hydrochloride) SS ORAL ORAL Pregnancy Trihexyphenidyl Premature Separation Of Hydrochloride Placenta (Trihexyphenidyl Hydrochloride) Tablets SS ORAL 2 MG, 1 IN 1 DAY, ORAL Date:08/27/03ISR Number: 4180593-2Report Type:Expedited (15-DaCompany Report #NSADSS2002032085 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 1 MG, 2 IN 1 DAY, ORAL Date:08/27/03ISR Number: 4180595-6Report Type:Expedited (15-DaCompany Report #NSADSS2003024619 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Risperdal Constipation Professional (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Celexa (Citalopram Hydrobromide) C Norvasc (Amlodipine Besilate) C Aricept (Donepezil Hydrochloride) C Date:08/28/03ISR Number: 4182186-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030804047 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytoclastic Foreign Risperdal Initial or Prolonged Vasculitis Health (Risperidone) Professional Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Lipanthyl (Fenofibrate) C Novomix (Insulin Aspart) C Forlax (Macrogol) C Dafalgan (Paracetamol) C Imovane (Zopiclone) C 22-Feb-2006 08:20 AM Page: 1756 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/28/03ISR Number: 4182201-3Report Type:Expedited (15-DaCompany Report #APCDSS2003000394 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Cirrhosis Foreign Risperidone Leukopenia Health (Risperidone) Thrombocytopenia Professional Tablets PS ORAL 6 MG, 1 IN 1 DAY, ORAL Etizolam (Etizolam) Tablets SS ORAL 3 MG, 1 IN 1 DAY,ORAL Date:08/28/03ISR Number: 4182236-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030803645 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspartate Foreign Risperdal Hospitalization - Aminotransferase Study (Risperidone) Initial or Prolonged Increased Health Tablets PS 2 MG, 1 IN 1 Blood Potassium Decreased Professional DAY Cardiogenic Shock Tavor (Lorazepam) Fibrin D Dimer Tablets C Fibrin Increased Movicol (Nulytely) C Mydriasis Nitrite Urine Present Pulmonary Embolism Pupillary Reflex Impaired Red Blood Cell Count Tachycardia White Blood Cell Count White Blood Cells Urine Positive Date:08/28/03ISR Number: 4182241-4Report Type:Expedited (15-DaCompany Report #J081-002-001432 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Aricept (Donepezil Initial or Prolonged Extrapyramidal Disorder Health Hydrochloride) PS ORAL 3 MG, 1 IN 1 Parkinson'S Disease Professional D, ORAL Risperdal (Risperidone) SS ORAL 1 MG, ORAL Date:08/29/03ISR Number: 4175948-6Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041704A Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Tagonis PS Glaxosmithkline ORAL 20MG Unknown Initial or Prolonged Phosphokinase Increased Risperdal SS ORAL 5MG per day Parkinsonism Risperdal C ORAL 2MG Per day 8 MON Suicide Attempt Date:08/29/03ISR Number: 4179721-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030804621 Age:56 YR Gender:Male I/FU:I Outcome Death Hospitalization - 22-Feb-2006 08:20 AM Page: 1757 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Decreased Consumer Risperdal Coma (Risperidone) Drug Toxicity Tablets PS ORAL 3 MG, 1 IN 1 Myocardial Infarction DAY, ORAL Pneumonia Lithium (Lithium) Tablets C Depakote (Valproate Semisodium) C Diabetes (All Other Therapeutic Products) C Cardiac (Cardiac Therapy) C Date:08/29/03ISR Number: 4179790-1Report Type:Expedited (15-DaCompany Report #NSADSS2003024110 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Hyperosmolar Health Risperdal Initial or Prolonged Coma Professional (Risperidone) Diabetic Ketoacidosis Tablets PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Insulin C Depakote (Valproate Semisodium) C Wellbutrin (Bupropion Hydrochloride) C Lithium (Lithium) C Synthroid (Levothyroxine Sodium) C Cogentin (Benzatropine Mesilate) C Date:08/29/03ISR Number: 4179793-7Report Type:Expedited (15-DaCompany Report #NSADSS2003023734 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Consumer Risperdal Death Health (Risperidone) Disturbance In Attention Professional Tablets PS ORAL 3 MG, 1 IN 1 DAY, ORAL Benadryl (Diphenhydramine Hydrochloride) C Date:08/29/03ISR Number: 4179796-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030604428 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Death Bronchopneumonia Health Myocardial Infarction Professional Company 22-Feb-2006 08:20 AM Page: 1758 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Risperdal (Risperidone) Tablets PS ORAL 1 MG, 2 IN 1 DAY, ORAL Xanax (Alprazolam) C Lexapro (All Other Therapeutic Products) C Date:08/29/03ISR Number: 4179797-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030805365 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:08/29/03ISR Number: 4179800-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030804529 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:08/29/03ISR Number: 4179801-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030804625 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Date:08/29/03ISR Number: 4182287-6Report Type:Expedited (15-DaCompany Report #EMADSS2003004062 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Foreign Risperdal Hyponatraemia Health (Risperidone) Water Intoxication Professional Tablets PS ORAL 4 MG, 4 IN 1 Company DAY, ORAL Representative Loxapac (Loxapine Succinate) C Temesta (Lorazepam) C Parkinane (Trihexyphenidyl Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1759 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/29/03ISR Number: 4182296-7Report Type:Expedited (15-DaCompany Report #APCDSS2003000397 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Autoimmune Foreign Risperidone Hospitalization - Thrombocytopenia Health (Risperidone) Initial or Prolonged Haemorrhage Professional Tablets PS ORAL 3 MG, 1 IN 1 Oedema Peripheral DAY, ORAL Pneumonia Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) Tablets SS ORAL 62.5 MG, 1 IN 1 DAY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) Tablets C Pantethine (Pantethine) Tablets C Date:09/02/03ISR Number: 4183564-5Report Type:Expedited (15-DaCompany Report #NSADSS2003019721 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Consumer Risperdal Sedation (Risperidone) Weight Increased Tablets PS ORAL 2 IN 1 DAY, ORAL Calcium (Calcium) C Date:09/02/03ISR Number: 4183578-5Report Type:Expedited (15-DaCompany Report #NSADSS2003002253 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Health Risperdal Body Temperature Professional (Risperidone) Confusional State Tablets PS ORAL 0.5 MG, 1 IN Coronary Artery 1 DAY, ORAL Atherosclerosis Amiodarone Dry Skin (Amiodarone) C Feeling Hot Lopressor Heart Rate (Metoprolol Oxygen Saturation Tartrate) C Decreased Aggrenox (Asasantin) C Respiratory Rate Megace (Megestrol Increased Acetate) C Prevacid (Lansoprazole) C Norvasc (Amlodipine Besilate) C Synthroid (Levothyroxine Sodium) C Nitro-Dur (Glyceryl Trinitrate) C Robitussin (Guaifenesin) C Tylenol 22-Feb-2006 08:20 AM Page: 1760 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Paracetamol) C Date:09/02/03ISR Number: 4183580-3Report Type:Expedited (15-DaCompany Report #NSADSS2002011528 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Risperdal Sepsis Professional (Risperidone) Unspecified PS ORAL ORAL Date:09/02/03ISR Number: 4183583-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030805372 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 3 MG, 1 IN 1 DAY, ORAL Date:09/02/03ISR Number: 4183585-2Report Type:Expedited (15-DaCompany Report #NSADSS2002009800 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Consumer Risperdal Haemorrhage Health (Risperidone) Hepatic Cirrhosis Professional Tablets PS ORAL 3 MG, 2 IN 24 HOUR, ORAL Date:09/02/03ISR Number: 4183587-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030804067 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL Date:09/02/03ISR Number: 4183635-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030804394 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Foreign Risperidone Increased Health (Risperidone) PS ORAL 0.5 MG, 1 IN Leukopenia Professional 1 DAY, ORAL Thrombocytopenia Date:09/02/03ISR Number: 4183637-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030805071 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Foreign Risperdal Hospitalization - Circulatory Collapse Health (Risperidone) PS ORAL 4 MG, 1 IN 1 Initial or Prolonged Myocardial Infarction Professional DAY, ORAL Disability Ventricular Fibrillation Clozapine Other (Clozapine) SS ORAL 800 MG, 1 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1761 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/02/03ISR Number: 4183640-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030805070 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Infarction Foreign Risperdal Life-Threatening Cerebrovascular Accident Health (Risperidone) PS ORAL 4 MG, IN 1 Circulatory Collapse Professional DAY, ORAL Dizziness Clozapine Orthostatic Hypotension (Clozapine) SS ORAL 625 MG, IN 1 DAY, ORAL Desmopressin (Desmopressin) C Metformin (Metformin) C Lansoprazole (Lansoprazole) C Lorazepam (Lorazepam) C Date:09/02/03ISR Number: 4183642-0Report Type:Expedited (15-DaCompany Report #DK-JNJFOC-20030805431 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Foreign Risperdal Sedation Health (Risperidone) Stridor Professional Tablets PS ORAL 0.5 MG , 1 IN Swelling Face 1 DAY, ORAL : Weight Increased 1 MG , 2 IN 1 DAY, ORAL Cipramil(Citalopram Hydrobromide) Tablets C Date:09/03/03ISR Number: 4184529-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030805358 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Risperidone) Professional Solution PS ORAL SEE IMAGE Date:09/03/03ISR Number: 4184553-7Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20030707073 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Foreign Risperdal Phosphokinase Increased Health (Risperidone) Cardiogenic Shock Professional Unspecified PS ORAL 0.5 MG, ORAL Coma Topamax (Topiramate) Hyperthermia Malignant Unspecified SS ORAL 200 MG, ORAL Myoglobin Blood Increased Pleural Effusion Pulmonary Oedema 22-Feb-2006 08:20 AM Page: 1762 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/03ISR Number: 4184729-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030805869 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscular Weakness Foreign Risperdal Consumer (Risperidone) Unspecified PS 0.5 MG Date:09/03/03ISR Number: 4184736-6Report Type:Expedited (15-DaCompany Report #EMADSS2003003719 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Risperdal Initial or Prolonged Neutropenia Health (Risperidone) Professional Unspecified PS 6 MG 1 IN 1 AS NECESSARY Clopixol (Zuclopenthixol Decanoate) SS ORAL SEE IMAGE Temesta (Lorazepam) Unspecified SS 4.5 MG Konakion (Phytomenadione) C Date:09/03/03ISR Number: 4184739-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030700011 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Risperdal Initial or Prolonged Pulmonary Embolism Health (Risperidone) Weight Increased Professional Unspecified PS ORAL SEE IMAGE Marcumar (Phenprocoumon) SS Zyprexa (Olanzapine) SS ORAL 30 MG 1 IN 1 DAY ORAL Nizak (Nizatidine) C Pantozol (Pantoprazole Sodium) C Date:09/03/03ISR Number: 4184800-1Report Type:Expedited (15-DaCompany Report #NSADSS2002041916 Age:78 YR Gender:Female I/FU:F Outcome PT Death Agitation Hospitalization - Arteriosclerosis Initial or Prolonged Atrial Fibrillation Required Bacterial Infection Intervention to Blood Creatinine Prevent Permanent Blood Urea Impairment/Damage Cardiac Failure Congestive Cardiomegaly Cardiovascular Disorder Cellulitis Cerebral Infarction Cerebrovascular Accident Coma Crying 22-Feb-2006 08:20 AM Page: 1763 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Culture Urine Positive Dehydration Electrocardiogram St-T Report Source Product Role Manufacturer Route Dose Duration Segment Abnormal Consumer Risperdal Escherichia Urinary Tract (Risperdone) Infection Unspecified PS ORAL SEE IMAGE Hiatus Hernia Lanoxin (Digoxin) C Hypertension Serzone (Nefazodone Klebsiella Infection Hydrochloride) C Muscle Contracture Insulin (Insulin) C Neuroleptic Malignant Trental Syndrome (Pentoxifylline) C Oedema Peripheral Ditropan Pleural Effusion (Oxybutynin) C Pneumonia Aspiration Antivert (Ancovert) C Pseudomonas Infection Ritalin Pulmonary Congestion (Methylphenidate Restlessness Hydrochloride) C Sepsis Florinef Staphylococcal Infection (Fludrocortisone Syncope Acetate) C Ultram (Tramadol Hydrochloride ) C Parlodel (Bromocriptine Mesilate) C Corgard (Nadolol) C Claritin (Loratadine) C Glucotrol (Glipizide) C Lomotil (Lomotil) C Date:09/04/03ISR Number: 4185073-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030802204 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Galantamine Initial or Prolonged Condition Aggravated Health (Galantamine) Confusional State Professional Unspecified PS ORAL 10 MG, ORAL Dementia Alzheimer'S Type Risperdal Drug Interaction (Risperidone) Incoherent Tablets SS 1 IN 1 DAY Prostration Athymil (Mianserin Hydrochloride) SS ORAL 60 MG, 1 IN 1 DAY, ORAL Stilnox (Zolpidem) SS ORAL 10 MG, ORAL Date:09/04/03ISR Number: 4185077-3Report Type:Expedited (15-DaCompany Report #BR-JNJFOC-20030806067 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Foreign Risperdal Initial or Prolonged Headache Consumer (Risperidone) PS ORAL 2 MG, 1 IN 1 Hyperhidrosis DAY, ORAL Malaise Rivotril Myalgia (Clonazepam) C Nystagmus Tongue Paralysis 22-Feb-2006 08:20 AM Page: 1764 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/04/03ISR Number: 4185080-3Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20030806152 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Foreign Risperdal Health (Risperidone) PS 4 MG, 1 IN 1 Professional DAY Epilim (Valproate Sodium) SS 2000 MG, 1 IN 1 DAY Date:09/05/03ISR Number: 4180091-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB03348 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Infarction Clozapine PS Novartis Sector: Cerebrovascular Accident Pharma ORAL 625mg/day Circulatory Collapse Risperdal SS ORAL 4mg/day Dizziness Desmopressin C ORAL 200ug/day Orthostatic Hypotension Metformin C ORAL 850 mg, TID Lansoprazole C ORAL 30mg/day Lorazepam C ORAL 0.5mg/day Date:09/05/03ISR Number: 4180239-3Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0041704A Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Tagonis PS Glaxosmithkline ORAL 20MG Unknown Initial or Prolonged Phosphokinase Increased Risperdal SS ORAL 5MG per day Parkinsonism Risperdal C ORAL 2MG Per day 8 MON Date:09/05/03ISR Number: 4185918-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030604172 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polycystic Ovaries Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 6 MG 1 IN 1 DAY ORAL Depixol (Injection) Flupentixol Decanoate C Reboxetine (Reboxetine) C Procyclidine (Procyclidine) C Date:09/05/03ISR Number: 4186005-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030707392 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Loss Of Consciousness Foreign Risperidone Road Traffic Accident Health (Risperidone) Tablet PS ORAL 8 MG, 1 IN 1 Professional DAY, ORAL Flunitrazepam (Flunitrazepam) Tablets C Brotizolam 22-Feb-2006 08:20 AM Page: 1765 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Brotizolam) C Nitrazepam (Nitrazepam) C Date:09/05/03ISR Number: 4186006-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030805293 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disseminated Foreign Risperidone Intravascular Coagulation Health (Risperidone) Thrombocytopenia Professional Tablets PS ORAL 1 MG, IN 1 DAY, ORAL Famotidine (Famotidine) Tablets C Clostridium Butyricum (All Other Therapeutic Products) C Alfacalcidol (Alfacalcidol) Capsules C Calcium Polystyrene Sulfonate (Calcium Polystyrene Sulfonate) C Loperamide Hydrochloride (Loperamide Hydrochloride) Unspecified C Levofloxacin (Levofloxacin) Unspecified C Sodium Rabeprazole (Rabeprazole Sodium) Tablets C Amezinium Metilsulfate (Amezinium Metilsulfate) C Date:09/05/03ISR Number: 4186009-4Report Type:Expedited (15-DaCompany Report #EMADSS2002006126 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Foreign Haldol (Haloperidol) Initial or Prolonged Thromboplastin Time Health Unspecified PS ORAL ORAL Prolonged Professional Risperdal Antinuclear Antibody (Risperidone) Positive Unspecified SS ORAL ORAL Antiphospholipid Seresta (Oxazepam) C Antibodies Positive Theralene Dna Antibody Positive (Alimemazine Thrombocytopenia Tartrate) C Implanon (Etonogestrel) Implant C Birodogyl (Rhodogil) Unspecified C Mepronizine 22-Feb-2006 08:20 AM Page: 1766 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Mepronizine) Unspecified C Sulfarlem (Anethole Trithione) C Date:09/05/03ISR Number: 4186428-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030802407 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gamma-Glutamyltransferase Foreign Risperdal Increased Health (Risperidone) Professional Unspecified PS ORAL 8 MG, 1 IN 1 DAY, ORAL Laroxyl (Amitriptyline Hydrochloride) C Tranxene (Clorazepate Dipotassium) C Date:09/05/03ISR Number: 4186429-8Report Type:Expedited (15-DaCompany Report #EMADSS2003000924 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Foreign Risperdal Pregnancy Health (Risperidone) False Positive Laboratory Professional Tablets PS ORAL 4 MG, 2 IN 1 Result DAY, ORAL Largactil (Unspecified) Chlorpromazine Hydrochloride C Depamide (Unspecified) Valpromide C Date:09/05/03ISR Number: 4186431-6Report Type:Expedited (15-DaCompany Report #EMADSS2002006126 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Foreign Haldol (Haloperidol) Initial or Prolonged Positive Health Unspecified PS ORAL ORAL Antiphospholipid Professional Risperdal Antibodies Positive (Risperidone) Circulating Anticoagulant Unspecified SS ORAL ORAL Thrombocytopenia Seresta (Oxazepam) C Theralene (Alimemazine Tartrate) C Implanon (Etonogestrel) C Birodogyl (Rhodogil) C Mepronizine (Mepronizine) C Sulfarlem (Anethole Trithione) C 22-Feb-2006 08:20 AM Page: 1767 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/08/03ISR Number: 4185583-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030900039 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Toxicity Foreign Risperdal Overdose Health (Risperidone) PS ORAL 0.5 MG, 2 IN Respiratory Arrest Professional 1 DAY, ORAL Airomir (Salbutamol Sulfate) SS RESPIRATORY (INHALATION) SEE IMAGE Pulmicort (Budesonide) C Date:09/08/03ISR Number: 4185584-3Report Type:Expedited (15-DaCompany Report #NSADSS2003004539 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypopituitarism Health Risperdal Initial or Prolonged Hypothyroidism Professional (Risperidone) Other Pituitary Haemorrhage Tablets PS ORAL 3 MG, 2 IN 1 Pituitary Tumour Benign DAY, ORAL Visual Acuity Reduced Desipramine (Desipramine) C Benadryl (Diphenhydramine Hydrochloride) C Date:09/08/03ISR Number: 4185586-7Report Type:Expedited (15-DaCompany Report #NSADSS2003014601 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS Date:09/08/03ISR Number: 4185643-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601222 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Health Risperdal White Blood Cell Count Professional (Risperidone) Abnormal Tablets PS 0.5 MG, 2 IN 1 DAY Date:09/08/03ISR Number: 4186837-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030804394 Age:20 YR Gender:Female I/FU:F Outcome PT Life-Threatening Alanine Aminotransferase Aspartate Aminotransferase Blood Alkaline Phosphatase Blood Lactate Dehydrogenase C-Reactive Protein Increased Gamma-Glutamyltransferase Leukopenia 22-Feb-2006 08:20 AM Page: 1768 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Septic Shock Somnolence Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Foreign Risperidone Health (Risperidone) Professional Unspecified PS ORAL 1 MG, 1 IN 1 DAY, ORAL Solita-T 3g (Injection) Solita-T 3g C Date:09/08/03ISR Number: 4186945-9Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20030801946 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Foreign Risperdal Initial or Prolonged Corrected Interval Health (Risperidone) Prolonged Professional Unspecified PS ORAL 2 MG, ORAL Hypokalaemia Dominal Ventricular Extrasystoles (Prothipendyl Hydrochloride) SS 40 MG Zestril (Lisinopril) C Amlor (Amlodipine Besilate) C Kalium Durettes (Potassium Chloride) C Date:09/08/03ISR Number: 4186949-6Report Type:Expedited (15-DaCompany Report #APCDSS2003000397 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Autoimmune Foreign Risperidone Hospitalization - Thrombocytopenia Health (Risperidone) Initial or Prolonged Haemorrhage Professional Tablets PS ORAL 3 MG, 1 IN 1 Oedema Peripheral DAY, ORAL Pneumonia Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) Tablets SS ORAL 62.5 MG, 1 IN 1 DAY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) C Pantethine (Pantethine) C Date:09/09/03ISR Number: 4187564-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030901233 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Risperdal Congestive Professional (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1769 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/03ISR Number: 4187566-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030901230 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL Date:09/09/03ISR Number: 4188256-4Report Type:Expedited (15-DaCompany Report #NSADSS2003008536 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Prolactinoma Health Risperdal Initial or Prolonged Professional (Risperidone) Other Company Tablets PS ORAL ORAL Representative L-Thyroxine (Levothyroxine Sodium) C Prozac (Fluoxetine Hydrochloride) C Topamax (Topiramate) C Ritalin Sr (Methylphenidate Hydrochloride) C Wellbutrin Sr (Bupropion Hydrochloride) C Neurontin (Gabapentin) C Date:09/09/03ISR Number: 4188258-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030704285 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Risperdal Respiratory Failure Professional (Risperidone) Unspecified PS ORAL ORAL Date:09/09/03ISR Number: 4188260-6Report Type:Expedited (15-DaCompany Report #NSADSS2002047739 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 0.5 DOSE(S), 1 IN 1 DAY, ORAL Aricept (Donepezil Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Date:09/10/03ISR Number: 4188499-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030901361 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) 22-Feb-2006 08:20 AM Page: 1770 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablets PS ORAL ORAL Date:09/10/03ISR Number: 4188501-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030901354 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Risperdal Decreased Professional (Risperidone) PS ORAL 2.5 MG, 1 IN 1 DAY, ORAL Nadolol (Nadolol) C Date:09/10/03ISR Number: 4188943-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030901195 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Foreign Reminyl Other Electrocardiogram Health (Galantamine) Abnormal Professional Tablets PS ORAL 4 MG, 2 IN 1 Electrocardiogram Qt DAY, ORAL Prolonged Risperdal Myocardial Ischaemia (Risperidone) Syncope Tablets SS ORAL 2 MG, ORAL Beloc Zoc (Beloc-Zoc Comp) C Date:09/11/03ISR Number: 4186975-7Report Type:Direct Company Report #CTU 201627 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Prolactin Increased Risperdal 2 Mg PS ORAL 2 MG AM ORAL Intervention to Breast Mass Risperdal 4 Mg SS ORAL 4MG HS ORAL Prevent Permanent Impairment/Damage Date:09/11/03ISR Number: 4189065-2Report Type:Expedited (15-DaCompany Report #2003-09-0503 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Overdose Foreign Airomir Hfa Oral Hospitalization - Respiratory Arrest Health Aerosol (Salbutamol Initial or Prolonged Self-Medication Professional Sulfate) PS RESPIRATORY (INHALATION) 2 PUFFS QD* ORAL AER INH Risperidone SS ORAL 0.5 MG BID ORAL Pulmicort Inhalation Solution C Salbutamol (Albuterol) C Date:09/11/03ISR Number: 4189100-1Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20030901644 Age: Gender:Female I/FU:I Outcome PT Other Colon Cancer Hepatic Neoplasm Malignant 22-Feb-2006 08:20 AM Page: 1771 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leukaemia Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Risperidone) Professional Unspecified PS Date:09/12/03ISR Number: 4189099-8Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20030901447 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coagulopathy Foreign Risperdal Initial or Prolonged Health (Risperidone) Professional Unspecified PS ORAL 1 MG, 2 IN 1 DAY, ORAL Tranxene (Clorazepate Dipotassium) C Date:09/12/03ISR Number: 4189748-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030902178 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS Professional Date:09/12/03ISR Number: 4189749-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030604176 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Risperdal Pneumonia Professional (Risperidone) PS 1 MG, 1 IN 1 DAY Isosorbide C Zantac (Ranitidine Hydrochloride) C Digoxin C Zestril (Lisinopril) C Lipitor (Atorvastatin) C Lasix (Furosemide) C Insulin C Depakote (Valproate Semisodium) C Trazodone C Date:09/12/03ISR Number: 4190230-9Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20030707073 Age:47 YR Gender:Female I/FU:F Outcome PT Life-Threatening Blood Creatine Phosphokinase Increased Cardiogenic Shock Coma Hyperthermia Malignant Loss Of Consciousness 22-Feb-2006 08:20 AM Page: 1772 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myoglobin Blood Increased Pleural Effusion Pulmonary Oedema Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 0.5 MG, ORAL Topamax (Topiramate) Unspecified SS ORAL 200 MG, ORAL Date:09/12/03ISR Number: 4190277-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030901828 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:09/15/03ISR Number: 4190292-9Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20030901921 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Dreams Foreign Risperdal Initial or Prolonged Dyspepsia Consumer (Risperidone) Fatigue Unspecified PS ORAL 5 MG, 1 IN 1 Feeling Abnormal DAY, ORAL; 2 Headache MG, 1 IN 1 Hypoaesthesia DAY, ORAL Somnolence Topamax (Topiramate) SS 100 MG, 3 IN Vision Blurred 1 DAY Estrogen (Estrogen Nos) C Date:09/15/03ISR Number: 4190293-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030707392 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Loss Of Consciousness Foreign Risperidone Road Traffic Accident Health (Risperidone) Professional Tablets PS ORAL 8 MG, 1 IN 1 DAY, ORAL Flunitrazepam (Flunitrazepam) Tablets C Brotizolam (Brotizolam) C Nitrazepam (Nitrazepam) C Date:09/15/03ISR Number: 4190294-2Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20030707073 Age:47 YR Gender:Female I/FU:F Outcome PT Life-Threatening Blood Creatine Phosphokinase Increased Cardiogenic Shock Coma Hyperthermia Malignant 22-Feb-2006 08:20 AM Page: 1773 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Myoglobin Blood Increased Pleural Effusion Report Source Product Role Manufacturer Route Dose Duration Pulmonary Oedema Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 0.5 MG, ORAL Topamax (Topiramate) SS ORAL 200 MG, ORAL Date:09/15/03ISR Number: 4190295-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030805358 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Risperidone) Professional Solution PS ORAL 3 ML, 4 IN 1 DAY, ORAL; 2 ML, 4 IN 1 DAY, ORAL Valium (Diazepam) C Date:09/15/03ISR Number: 4190710-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030902010 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Risperidone Initial or Prolonged Amenorrhoea Health (Risperidone) PS ORAL SEE IMAGE Anxiety Professional Haloperidol Blood Prolactin Increased (Haloperidol) Dyspnoea Injection SS INTRAVENOUS Refusal Of Treatment By DRIP 20 MG, IN 1 Patient DAY, Speech Disorder INTRAVENOUS Suicide Attempt DRIP Date:09/15/03ISR Number: 4190712-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030901126 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Death Of Child Foreign Risperdal Road Traffic Accident Health (Risperidone) PS ORAL ORAL Professional Tercian (Cyamemazine) C Date:09/15/03ISR Number: 4190717-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030901411 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiovascular Disorder Foreign Risperdal Hyperhidrosis Health (Risperidone) Pyrexia Professional Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Antibiotic (Antibiotics) SS 22-Feb-2006 08:20 AM Page: 1774 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/03ISR Number: 4190720-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030901409 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:09/15/03ISR Number: 4190723-4Report Type:Expedited (15-DaCompany Report #APCDSS2003000151 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperidone Initial or Prolonged Flatulence Health (Risperidone) Hyperprolactinaemia Professional Tablets PS ORAL 4 MG, 1 IN 1 Ileus DAY, ORAL Nausea Candesartan Vomiting Cilexetil (Candesartan Cilexetil) C Senna Extract (Senna Liquid Extract) C Haloperidol (Haloperidol) C Levomepromazine Maleate (Levopromazine Maleate) C Date:09/15/03ISR Number: 4190725-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030805293 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperidone Health (Risperidone) Professional Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Famotidine (Famotidine) C Clostridium Butyricum (All Other Therapeutic Products) C Alfacalcidol (Alfacalcidol) C Calcium Polystyrene Sulfonate (Calcium Polystyrene Sulfonate) C Loperamide Hydrochloride (Loperamide Hydrochloride) C Levofloxacin (Levofloxacin) C Sodium Rabeprazolem (Rabeprazole Sodium) C Amezinium Metilsulfate (Amezinium 22-Feb-2006 08:20 AM Page: 1775 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Metilsulfate) C Date:09/15/03ISR Number: 4190727-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030902010 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Risperidone Initial or Prolonged Amenorrhoea Health (Risperidone) Blood Prolactin Increased Professional Unspecified PS ORAL SEE IMAGE Dyspnoea Haloperidol Speech Disorder (Haloperidol) Suicide Attempt Injection SS INTRAVENOUS DRIP 20 MG, IN 1 DAY, INTRAVENOUS DRIP Date:09/16/03ISR Number: 4190329-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030902464 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Health Risperdal Professional (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY, ORAL Wellbutrin Sr (Bupropion Hydrochloride) SS ORAL 100 MG, 1 IN 1 DAY, ORAL Date:09/16/03ISR Number: 4190330-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030902469 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Risperdal Decreased Professional (Risperidone) PS ORAL 3 MG, 1 IN 1 DAY, ORAL Date:09/16/03ISR Number: 4190814-8Report Type:Direct Company Report #USP 080514 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Risperdal PS Janssen TABLET Ridaura SS Smith Kline Beecham CAPSULE Date:09/16/03ISR Number: 4190979-8Report Type:Direct Company Report #USP 080564 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Risperdal PS Janssen TABLETS Rifampin SS CAPSULES 22-Feb-2006 08:20 AM Page: 1776 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/16/03ISR Number: 4191114-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030802407 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gamma-Glutamyltransferase Foreign Risperdal Increased Health (Risperidone) Professional Unspecified PS ORAL 8 MG, 1 IN 1 DAY, ORAL Laroxyl (Amitriptyline Hydrochloride) C Tranxene (Clorazepate Dipotassium) C Date:09/16/03ISR Number: 4191117-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030703313 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Breast Neoplasm Foreign Risperidone Initial or Prolonged Breast Neoplasm Male Health (Risperidone) Other Professional Unspecified PS ORAL ORAL Date:09/17/03ISR Number: 4191529-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030902474 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atelectasis Consumer Risperdal Chest Pain (Risperidone) Pleural Effusion Tablets PS ORAL 2 MG, 1 IN 1 DAY, ORAL Klonopin ( ) Clonazepam C Lexaprol ( ) Allother Therapeutic Products C Date:09/17/03ISR Number: 4192682-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030802204 Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Risperdal Initial or Prolonged Confusional State Health (Risperidone) Dementia Alzheimer'S Type Professional Tablets PS 1 IN 1 DAY Drug Interaction Galantamine Epilepsy (Galantamine) C Incoherent Stilnox (Zolpidem) C Prostration Athymil (Mianserin Hydrochloride) C Date:09/17/03ISR Number: 4192685-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030805578 Age: Gender:Female I/FU:I Outcome PT Other Cardiac Murmur Dyspnoea Fatigue Hypotrichosis 22-Feb-2006 08:20 AM Page: 1777 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Memory Impairment Pain In Extremity Swelling Face Report Source Product Role Manufacturer Route Dose Duration Thrombosis Foreign Risperdal Vision Blurred (Risperidone) Weight Decreased Unspecified PS Date:09/17/03ISR Number: 4192686-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030901094 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Risperdal Initial or Prolonged Encephalopathy Health (Risperidone) Loss Of Consciousness Professional Unspecified PS ORAL 0.75 MG, 1 IN 1 DAY, ORAL Nolvadex (Tamoxifen) C Duphalac (Lactulose) C Amlor (Amlodipine Besilate) C Nitriderm (Glyceryl Trinitrate) C Date:09/17/03ISR Number: 4192688-8Report Type:Expedited (15-DaCompany Report #EMADSS2003004514 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Risperdal Initial or Prolonged Alanine Aminotransferase Consumer (Risperidone) Other Increased Health Tablets PS ORAL 0.5 MG, 2 IN Aspartate Professional 1 DAY, ORAL Aminotransferase Aspirin Increased (Acetylsalicylic Bile Duct Stone Acid) C Blood Bilirubin Increased Cholangitis Contusion Jaundice Lethargy Liver Function Test Abnormal Sepsis Date:09/17/03ISR Number: 4193380-6Report Type:Expedited (15-DaCompany Report #2003AP00095 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Foreign Seroquel PS ORAL 150 MG DAILY Intervention to Delusion Health PO Prevent Permanent Diabetes Mellitus Professional Seroquel SS ORAL 300 MG DAILY Impairment/Damage Hallucination Other PO Hepatic Function Abnormal Seroquel SS ORAL 400 MG DAILY Hepatic Steatosis PO Seroquel SS ORAL 600 MG DAILY PO Seroquel SS ORAL 200 MG DAILY PO Seroquel SS ORAL 150 MG DAILY PO 22-Feb-2006 08:20 AM Page: 1778 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chlorpromazine Hydrochloride SS Risperidone SS ORAL 2 MG DAILY PO Risperidone SS ORAL 6 MG DAILY PO Haloperidol C Biperiden Hydrochloride C Levomepromazine Maleate C Nitrazepam C Promethasone C Olanzapine C Mexazolam C Date:09/22/03ISR Number: 4190468-0Report Type:Expedited (15-DaCompany Report #WAES 0305USA00828 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Galactorrhoea Pepcid Rpd PS ORAL 196 DAY Neuropathy Risperidone SS ORAL 32 DAY Bezatol C Merck & Co., Inc Magnesium Oxide C Predonine C Predonine C Rize C Date:09/22/03ISR Number: 4194758-7Report Type:Expedited (15-DaCompany Report #2003017238 Age:25 YR Gender:Male I/FU:F Outcome PT Life-Threatening Activated Partial Hospitalization - Thromboplastin Time Initial or Prolonged Prolonged Other Anaemia Angioneurotic Oedema Anorexia Asthenia Blood Albumin Decreased Blood Chloride Increased Blood Fibrinogen Abnormal Blood Iron Decreased Blood Urea Decreased Cough Drug Toxicity Drug Withdrawal Syndrome Dyspnoea Hallucination Hyperhidrosis Hyperplasia Hyperpyrexia Insomnia Lymphadenopathy Lymphoma Muscular Weakness Nausea Paranoia Psychomotor Hyperactivity Rash Red Cell Distribution 22-Feb-2006 08:20 AM Page: 1779 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Width Increased Serum Ferritin Decreased Tachycardia Thrombocytopenia Report Source Product Role Manufacturer Route Dose Duration Vomiting Health Neurontin Weight Decreased Professional (Gabapentin) PS 1800 MG (600, White Blood Cell Count TID) Decreased Geodon (Ziprasidone) SS 160 MG Benzatropine Mesilate (Benzatropine Besilate) SS 4 MG Risperidone (Risperidone) SS 6 MG (3, BID) Venlafaxine Hydrochloride (Venlafaxine Hydrochloride) SS 75 MG (DAILY) Clonazepam (Clonazepam) C Haloperidol (Haloperidol) C Lamotrigine (Lamotrigine) C Lansoprazole (Lansoprazole) C Ranitidine Hydrochloride (Ranitidine Hy Drochloride) C Diphenhydramine Hydrochloride (Diphenhydramine Hydrochloride) C Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Olanzapine (Olanzapine) C Lorazepam (Lorazepam) C Temazepam (Temazepam) C Zolpidem Tartrate (Zolpidem Tartrate) C Date:09/22/03ISR Number: 4195033-7Report Type:Expedited (15-DaCompany Report #NSADSS2002032903 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1780 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/03ISR Number: 4195211-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030901704 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acquired Diaphragmatic Foreign Reminyl Initial or Prolonged Eventration Health (Galantamine) Other Blood Bilirubin Increased Professional Solution PS ORAL ORAL Blood Creatine Risperdal Contra Phosphokinase Increased (Risperdal) Blood Lactate Microspheres SS INTRAMUSCULAR SEE IMAGE Dehydrogenase Increased C-Reactive Protein Increased Chills Drug Interaction Dysphagia Haemoglobin Decreased Hyperhidrosis Hypertonia Liver Function Test Abnormal Myoglobin Blood Increased Neuroleptic Malignant Syndrome Oculogyration Oedema Peripheral Platelet Count Red Blood Cell Count Speech Disorder Tachyarrhythmia Tremor Date:09/22/03ISR Number: 4195880-1Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20030700883 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystectomy Foreign Risperidone Initial or Prolonged Drug Toxicity Consumer (Risperidone) PS Disability Dyspepsia Other Gastrooesophageal Reflux Disease Lung Disorder Overdose Respiratory Failure Vomiting Date:09/22/03ISR Number: 4196270-8Report Type:Expedited (15-DaCompany Report #NZ-JNJFOC-20030804760 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Flutter Foreign Risperdal Initial or Prolonged Cardiac Failure Health (Risperidone) PS ORAL 0.25 MG, IN 1 Cardiac Murmur Professional DAY, ORAL Condition Aggravated Aspirin Dyspnoea (Acetylsalicylic Acid) C Accupril (Quinapril Hydrochloride) C Frusemide (Furosemide) C 22-Feb-2006 08:20 AM Page: 1781 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lipex (Simvastatin) C Date:09/22/03ISR Number: 4196271-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030901715 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Risperdal Confusional State Consumer (Risperidone) PS ORAL ORAL Disturbance In Attention Dizziness Emotional Disorder Hallucination Headache Hypoaesthesia Memory Impairment Mood Altered Muscle Spasms Paranoia Social Avoidant Behaviour Date:09/22/03ISR Number: 4196272-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030901766 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Neoplasm Foreign Risperdal Hyperprolactinaemia Health (Risperidone) PS ORAL 6 MG, 1 IN 1 Professional DAY, ORAL Lorazepam (Lorazepam) C Quetiapin (Quetiapine) C Date:09/22/03ISR Number: 4196273-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030805578 Age:76 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Murmur Foreign Risperdal Dyspnoea (Risperidone) PS ORAL ORAL Fatigue Risperdal Consta Hypotrichosis (Risperidone) Memory Impairment Microspheres SS 50 MG, 1 IN 2 Pain In Extremity WEEK Swelling Face Thrombosis Vision Blurred Weight Decreased Date:09/22/03ISR Number: 4196296-4Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20030902341 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Self-Injury Foreign Risperdal Initial or Prolonged Thermal Burn Health (Risperidone) PS 1 MG, 2 IN 1 Thrombocythaemia Professional DAY 22-Feb-2006 08:20 AM Page: 1782 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/03ISR Number: 4190636-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12368411 Age:95 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Abilify Tabs 10 Mg PS Otsuka Initial or Prolonged Haemoglobin Decreased Pharmaceutical Haemorrhagic Stroke Company, Ltd. ORAL Hyponatraemia Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Abilify Tabs 10 Mg SS Otsuka Pharmaceutical Company, Ltd. ORAL Risperidone SS Asa C Ambien C Celebrex C Ditropan Xl C Prevacid C Os-Cal + D C Avapro C Bristol-Myers Squibb Company Miacalcin C NASAL Altace C Discontinued due to hyponatremia Iron C Date:09/23/03ISR Number: 4196179-XReport Type:Direct Company Report #CTU 202377 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Asthma Risperdal 1 Mg Condition Aggravated Tablets - Mfr Contusion Janssen PS Janssen ORAL 0.5 MG X2/DAY Difficulty In Walking ORAL Dizziness Atrovent Inhaler - Flashback Boehringer Ingelheim SS Boehringer Ingelheim RESPIRATORY Muscle Spasms (INHALATION) 2 PUFFS X 4 Tremor DAY Salasalate C Atropine C Ibuprofen C Cyclobenzaprine Hcl C Loperamide Hcl C Diphenoxylate C Promethazine Hcl C Ranitidine C Loratadine C Albuterol Inhaler C Date:09/23/03ISR Number: 4196236-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030802503 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Osmolarity Foreign Risperidone Initial or Prolonged Bone Marrow Depression Health (Risperidone) Other Feeling Abnormal Professional Unspecified PS ORAL 4 MG 1 IN 1 Microcytic Anaemia DAY ORAL Trihexyphenidyl 22-Feb-2006 08:20 AM Page: 1783 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride (Trihexyphenidyl Hydrochloride) Unknown SS ORAL 8 MG 1 IN 1 DAY ORAL Sulpiride (Sulpiride) SS ORAL 150 MG 1 IN 1 DAY ORAL Quetiapine Fumarate (Quetiapine Fumarate) Tablets SS ORAL 100 MG 1 IN 1 DAY ORAL Flunitrazepam (Flunitrazepam) SS ORAL 2 MG 1 IN 1 DAY ORAL Quazepam (Quazepam) SS ORAL 30 MG 1 IN 1 DAY ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS ORAL 25 MG 1 IN 1 DAY ORAL Date:09/23/03ISR Number: 4197086-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030804047 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukocytoclastic Foreign Risperdal Initial or Prolonged Vasculitis Health (Risperidone) Professional Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Laroscorbine (Ascorbic Acid) SS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Lipanthyl (Fenofibrate) SS ORAL ORAL Dafalgan (Paracetamol) SS ORAL 160 MG, 1 IN 1 DAY, ORAL Novomix (Insulin Aspart) SS SUBCUTANEOUS 3 G, 1 IN 1 DAY, SUBCUTANEOUS Forlax (Macrogol) SS ORAL ORAL Imovane (Zopiclone) SS ORAL 10 G, 1 IN 1 DAY, ORAL Date:09/23/03ISR Number: 4197088-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030902734 Age:1 WK Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Cerebral Atrophy Congenital Anomaly Complications Of Maternal Exposure To Therapeutic Drugs Congenital Hyperextension Of Spine Developmental Coordination Disorder 22-Feb-2006 08:20 AM Page: 1784 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Withdrawal Syndrome Dyskinesia Neonatal Dystonia Report Source Product Role Manufacturer Route Dose Duration Eye Movement Disorder Foreign Risperdal Forceps Delivery Health (Risperidone) Hypertonia Professional Unspecified PS TRANSPLACENTAL 3 MG, IN 1 Hypotonia Neonatal DAY, Irritability TRANSPLACENTA Maternal Drugs Affecting L Foetus Lysanxia (Prazepam) SS INTRA-UTERINE 10 MG, Nuclear Magnetic INTRAUTERINE Resonance Imaging Brain Clopixol Abnormal (Zuclopenthixol Opisthotonus Decanoate) SS INTRA-UTERINE 100 MG, 1 IN Overdose 1 WEEK, Poor Sucking Reflex INTRAUTERINE Reflexes Abnormal Lepticur (Tropatepine Hydrochloride) C Orocal (Calcium Carbonate) C Tardyferon (Ferrous Sulfate) C Date:09/23/03ISR Number: 4197128-0Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20030901447 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coagulopathy Foreign Risperdal Initial or Prolonged Hepatic Cirrhosis Health (Risperidone) PS ORAL 1 MG, 2 IN 1 Urethral Haemorrhage Professional DAY, ORAL Tranxene (Clorazepate Dipotassium) C Date:09/23/03ISR Number: 4197626-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904177 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY ORAL Date:09/23/03ISR Number: 4197627-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904158 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) PS Date:09/24/03ISR Number: 4193008-5Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0292231A Age:17 YR Gender:Female I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 1785 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Blood Aldosterone Deroxat PS Glaxosmithkline ORAL 20MG Per day 26 DAY Increased Risperdal SS ORAL 3MG Per day 5 DAY Drug Interaction Tercian C ORAL 45DROP Epistaxis Unknown 9 DAY Headache Zyprexa C ORAL 21 DAY Hypertension Lexomil C ORAL 3MG Per day 7 DAY Hypoaesthesia Phosphenes Tachycardia Date:09/24/03ISR Number: 4198237-2Report Type:Expedited (15-DaCompany Report #NSADSS2002026638 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Risperdal Hospitalization - Hip Fracture Professional (Risperidone) Initial or Prolonged Respiratory Disorder Unspecified PS ORAL SEE IMAGE Date:09/24/03ISR Number: 4198239-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904723 Age:43 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Literature Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Distributor Paroxetine (Paroxetine) SS Bupropion (Bupropion) SS Date:09/24/03ISR Number: 4198243-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904792 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Haldol (Haloperidol) Health Unspecified PS PARENTERAL PARENTERAL Professional Risperdal Distributor (Risperidone) Unspecified SS PARENTERAL PARENTERAL Valproic Acid (Valproic Acid) SS PARENTERAL PARENTERAL Date:09/24/03ISR Number: 4199808-XReport Type:Expedited (15-DaCompany Report #2003SE04084 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Complication Foreign Seroquel PS Pulmonary Embolism Health Seroquel SS ORAL 1000 MG DAILY Sudden Death Professional PO Other Risperdal SS INTRAMUSCULAR 50 MG BIWK IM Cardace C Primaspan C Atarax C Temesta C 22-Feb-2006 08:20 AM Page: 1786 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Obsidan C Insulin C Date:09/25/03ISR Number: 4200653-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030804394 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Risperidone Hospitalization - Increased Health (Risperidone) Initial or Prolonged Aspartate Professional Unspecfied PS ORAL 1 MG 1 IN 1 Aminotransferase DAY ORAL Increased Solita-T 3g Blood Culture Positive (Solita-T 3g) Blood Lactate Injection C Dehydrogenase C-Reactive Protein Increased Gamma-Glutamyltransferase Leukopenia Pneumonia Septic Shock Somnolence Thrombocytopenia Date:09/25/03ISR Number: 4200657-4Report Type:Expedited (15-DaCompany Report #NZ-JNJFOC-20030903942 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Foreign Risperdal Consta Health (Risperidone) Professional Unspecified PS HAS BEEN ON RISPERIDONE MICROSPHERE INJECTION FOR TEN WEEKS 10 WK Olanzapine (Olanzapine) C Paracetamol (Paracetamol) C Date:09/25/03ISR Number: 4200659-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030904254 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Face Oedema Foreign Risperidone Initial or Prolonged Insomnia Health (Risperidone) Oedema Professional Unspecified PS ORAL 2 MG IN 1 DAY Sluggishness ORAL Stevens-Johnson Syndrome Quetiapine (Quetiapine) Unknown SS ORAL 2 MG IN 1 DAY ORAL 22-Feb-2006 08:20 AM Page: 1787 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/25/03ISR Number: 4200660-4Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20030901644 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Colon Cancer Foreign Risperdal Other Fatigue Health (Risperidone) Hepatic Neoplasm Professional Unspecified PS 4 MG UNKNOWN Malignant Lithium (Lithium) C Leukaemia Clonazepam (Clonazepam) C Benztropine (Benzatropine Mesilate) C Date:09/25/03ISR Number: 4200842-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904911 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchospasm Health Risperdal Initial or Prolonged Dyspnoea Professional (Risperidone) Company Tablets PS ORAL 7 MG, 1 IN 1 Representative DAY, ORAL Atenolol (Atenolol C Hydrochlorothiazide( Hydrochlorothiazide) C Synthroid (Levothyroxine Sodium) C Diltiazem (Diltiazem) C Prednisone (Prednisone) C Z-Pac (Azithromycin) C Albuterol (Salbutamol) C Fluticasone (Fluticasone) C Date:09/25/03ISR Number: 4200846-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904306 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Date:09/26/03ISR Number: 4199350-6Report Type:Expedited (15-DaCompany Report #2003AP03253 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ecchymosis Foreign Seroquel PS ORAL 50 MG DAILY Initial or Prolonged Fall Health PO Femur Fracture Professional Risperdal SS 0.5 MG DAILY Hallucination, Visual Other Hyperpyrexia 22-Feb-2006 08:20 AM Page: 1788 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4199514-1Report Type:Expedited (15-DaCompany Report #2003038638 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Literature Lithium (Lithium) PS 900 MG (BID) Initial or Prolonged Increased Health Risperidone Aspartate Professional (Risperidone) SS Aminotransferase Olanzapine Increased (Olanzapine) C Blood Albumin Decreased Valproic Acid Blood Bilirubin Increased (Valproic Acid) C Blood Creatine Phosphokinase Increased Blood Creatinine Increased Blood Urea Increased Cerebral Atrophy Confusional State Consciousness Fluctuating Delirium Delusional Disorder, Unspecified Type Hallucination, Auditory Hyperpyrexia Hypertension Insomnia Lack Of Spontaneous Speech Motor Dysfunction Muscle Rigidity Neuroleptic Malignant Syndrome Tachycardia Tongue Spasm Tremor White Blood Cell Count Increased Date:09/26/03ISR Number: 4199519-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904305 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 2 MG, 1 IN 1 DAY, ORAL Date:09/26/03ISR Number: 4199520-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904916 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Risperdal Initial or Prolonged Facial Palsy Professional (Risperidone) PS ORAL 2 MG, ORAL Hypokinesia Modafil (Modafil) SS ORAL ORAL Incontinence Medication Error Somnolence 22-Feb-2006 08:20 AM Page: 1789 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4199521-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904301 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dyspnoea Consumer Risperdal Hospitalization - Pneumonia Health (Risperidone) PS 1 MG, 3 IN 1 Initial or Prolonged Professional DAY Date:09/26/03ISR Number: 4199572-4Report Type:Expedited (15-DaCompany Report #US-JNJF0C-20030905342 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) PS ORAL ORAL Depakote (Valproate Semisodium) C Aricept (Donepezil Hydrochloride) C Date:09/26/03ISR Number: 4200178-9Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20030901447 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coagulopathy Foreign Risperdal Initial or Prolonged Urethral Haemorrhage Health (Risperidone) Professional Unspecified PS ORAL 1 MG, 2 IN 1 DAY, ORAL Tranxene (Clorazepate Dipotassium) C Date:09/26/03ISR Number: 4200179-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030800951 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Neutropenia Health (Risperidone) Professional Tablets PS ORAL 2 MG, 1 IN 1 DAY, ORAL Depamide (Valpromide) C Stilnox (Zolpidem) C Date:09/26/03ISR Number: 4200180-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030905006 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Complications Of Maternal Foreign Risperdal Consta Exposure To Therapeutic Health (Risperidone) Drugs Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Intra-Uterine Death WEEK, Maternal Drugs Affecting INTRA-MUSCULA Foetus R Pregnancy Risperdal Premature Separation Of (Risperidone) Placenta Tablets SS ORAL 2 MG, 1 IN 1 DAY, ORAL Clopixol Decanoate 22-Feb-2006 08:20 AM Page: 1790 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Zuclopenthixol Decanoate) Injection SS INTRAMUSCULAR 600 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Chlorpromazine (Chlorpromazine) Tablets SS ORAL 25 MG, IN 1 AS NECESSARY, ORAL; 50 MG, IN 1 AS NECESSARY, Date:09/26/03ISR Number: 4200181-9Report Type:Expedited (15-DaCompany Report #JP-36350 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Exposure During Foreign Risperdal Consta Pregnancy Health (Risperidone) Intra-Uterine Death Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Premature Separation Of WEEK, Placenta INTRA-MUSCULA R Risperdal (Risperidone) Tablets SS ORAL 2 MG, 1 IN 1 DAY, ORAL Clopixol Decanoate (Zuclopenthixol Decanoate) Injection SS INTRAMUSCULAR 600 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Chlorpromazine (Chlorpromazine) Tablets SS ORAL 25 MG, IN 1 AS NECESSARY, ORAL; 50 MG, IN 1 AS NECESSARY, Date:09/26/03ISR Number: 4200207-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030707392 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Loss Of Consciousness Foreign Risperidone Road Traffic Accident Health (Risperidone) Professional Tablets PS ORAL 8 MG, IN 1 DAY, ORAL Flunitrazepam (Flunitrazepam) Tablets C Brotizolam (Brotizolam) C Nitrazepam (Nitrazepam) C Biperiden Hydrochloride (Biperiden Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1791 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sennoside (All Other Therapeutic Products) Tablets C Sodium Picosulfate (Sodium Picosulfate) Tablets C Vegetamin-A (Vegetamin A) C Date:09/26/03ISR Number: 4209536-XReport Type:Periodic Company Report #2002UW12659 Age:11 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dyskinesia Health Seroquel PS Intervention to Professional Risperdal SS Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210258-XReport Type:Periodic Company Report #2002AP04306 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Literature Quetiapine PS Health Oxycontin SS ORAL 120 MG DAILY Professional PO Diphenhydramine SS Promethazine SS Risperidone SS Venlafaxine C Propoxyphene C Zaleplon C Carisoprodol C Hydrocodone C Propranolol C Clonazepam C Chlorpromazine C Gabapentin C Date:09/26/03ISR Number: 4210309-2Report Type:Periodic Company Report #2003UW07033 Age:9 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Health Seroquel PS ORAL 25 MG TID PO Intervention to Professional Risperdal SS 1 MG TID Prevent Permanent Impairment/Damage Date:09/26/03ISR Number: 4210324-9Report Type:Periodic Company Report #2002UW13604 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Consumer Seroquel PS ORAL 200 MG BID PO Initial or Prolonged Thinking Abnormal Risperdal SS Risperdal C Depakote C Ativan C Protonix "Pharmacia" C 22-Feb-2006 08:20 AM Page: 1792 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/03ISR Number: 4210391-2Report Type:Periodic Company Report #2003UW03383 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Seroquel PS ORAL 800 MG PO Initial or Prolonged Extrapyramidal Disorder Professional Risperdal SS 8 MG Date:09/26/03ISR Number: 4210454-1Report Type:Periodic Company Report #2003UW00738 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Health Seroquel PS ORAL 400 MG BID PO Initial or Prolonged Hypotension Professional Seroquel SS ORAL 500 MG BID PO Psychotic Disorder Atenolol SS 75 MG BID Syncope Risperdal SS 1 MG BID Hydrochlorothiazide C Benazepril C Metoprolol C Date:09/29/03ISR Number: 4201556-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030903443 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Risperdal Initial or Prolonged Status Epilepticus Health (Risperidone) Professional Unspecified PS ORAL 2 MG, 1 IN 1 DAY, ORAL; 6 MG, 1 IN 1 DAY, ORAL; 4 MG, 1 IN 1 Date:09/29/03ISR Number: 4201557-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030903634 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Risperidone Initial or Prolonged Confusional State Health (Risperidone) Hypertension Professional Tablets PS ORAL 6 MG, ORAL Irritability Somnolence Syncope Date:09/29/03ISR Number: 4201700-9Report Type:Expedited (15-DaCompany Report #2003AP03281 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhage Subcutaneous Foreign Seroquel PS ORAL 25 MG TID PO Haemorrhagic Diathesis Health Wintermin SS ORAL 62.5 MG DAILY Idiopathic Professional PO Thrombocytopenic Purpura Other Wintermin SS ORAL 25 MG DAILY PO Risperdal SS ORAL 1 MG TID PO Serenace SS 0.75 MG TID Seven Ep C 22-Feb-2006 08:20 AM Page: 1793 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/03ISR Number: 4201742-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030805869 Age:83 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Foreign Risperdal Initial or Prolonged Hydronephrosis Consumer (Risperidone) Muscular Weakness Health Unspecified PS 0.5 MG, 2 IN Urinary Retention Professional 1 DAY Date:09/29/03ISR Number: 4202051-9Report Type:Expedited (15-DaCompany Report #200304797 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Literature Unspecified Hospitalization - Increased Other Acetaminophen Initial or Prolonged Aspartate Product PS ORAL PO Required Aminotransferase Lithium SS ORAL PO Intervention to Increased Risperidone SS ORAL PO Prevent Permanent Blood Bilirubin Increased Impairment/Damage Blood Creatine Phosphokinase Increased Blood Creatinine Increased Blood Lactate Dehydrogenase Increased Blood Ph Decreased Coma Completed Suicide International Normalised Ratio Increased Liver Function Test Abnormal Overdose Respiratory Rate Increased Restlessness Tachypnoea Urine Output Decreased Date:09/29/03ISR Number: 4202672-3Report Type:Expedited (15-DaCompany Report #200304771 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Literature Unspecified Required Increased Other Acetaminophen Intervention to Cardiac Arrest Product PS Prevent Permanent Completed Suicide Metoprolol SS Impairment/Damage Hyperkalaemia Aspirin SS Hypotension Risperidone SS Overdose Amphetamine/Dextroam Respiratory Arrest phetamine SS Tachycardia Naproxen SS Urine Output Decreased Multivtamin With Iron, Adult SS Vitamin E SS Diflusinal SS 22-Feb-2006 08:20 AM Page: 1794 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/30/03ISR Number: 4197660-XReport Type:Expedited (15-DaCompany Report #PHRM2003FR02433 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Nitriderm Tts PS Novartis Sector: Initial or Prolonged Blood Bicarbonate Pharma TRANSDERMAL 10 mg/24 h Convulsion Mepronizine SS ORAL 1 DF, QD Dyspnoea Kardegic SS ORAL 75 mg, QD Hyperhidrosis Risperdal SS ORAL 1,5 mg/day Hypoxia Forlax SS ORAL Iatrogenic Injury Date:09/30/03ISR Number: 4203072-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030905768 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 3 MG, 1 IN 1 DAY, ORAL Date:09/30/03ISR Number: 4203075-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030905351 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Contusion Consumer Risperdal Initial or Prolonged Diabetes Mellitus (Risperidone) Fall Tablets PS ORAL 0.25 MG, 2 IN Loss Of Consciousness 1 DAY, ORAL Renal Failure Date:09/30/03ISR Number: 4203077-1Report Type:Expedited (15-DaCompany Report #NSADSS2003011298 Age:42 YR Gender:Female I/FU:F Outcome PT Death Anaemia Hospitalization - Anger Initial or Prolonged Chronic Obstructive Pulmonary Disease Coma Confusional State Depression Disturbance In Attention Drug Ineffective Female Orgasmic Disorder Ganglion Hallucination, Auditory Headache Insomnia Mania Memory Impairment Pneumonia Pulmonary Hypertension Renal Failure Restlessness Sleep Apnoea Syndrome Suicidal Ideation Tachycardia Thinking Abnormal 22-Feb-2006 08:20 AM Page: 1795 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tumour Excision Weight Decreased Weight Increased Report Source Product Role Manufacturer Route Dose Duration Health Risperdal Professional (Risperidone) Tablets PS ORAL SEE IMAGE Effexor (Venlafaxine Hydrochloride) SS Wellbutrin (Bupropion Hydrochloride) SS Paxil (Paroxetine Hydrochloride) SS Remeron (Mirtazapine) SS Zoloft (Sertraline Hydrochloride) C Xanax (Alprazolam) C Klonopin (Clonazepam) C Lithium (Lithium) C Lasix (Furosemide) C Ambien (Zolpidem Tartrate) C Zyprexa (Olanzapine) C Neurontin (Gabapentin) C Synthroid (Levothyroxine Sodium) C Valium (Diazepam) C Geodon (Ziprasidone Hydrochloride) C Provigil (Modafinil) C Medicine For Htn (Antihypertensives) C Medicinese For Diabetes (Drug Used In Diabetes) C Zenical (Orlistat) C Date:09/30/03ISR Number: 4203139-9Report Type:Expedited (15-DaCompany Report #2003-00650FE Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Pentasa (Pentasa) Initial or Prolonged Loss Of Consciousness Professional (Mesalazine) PS ORAL G ORALLY Syncope Stilnox (Stilnox) (Zolpidem) SS ORAL 5 MG ORALLY Deroxat (Deroxat) (Paroxetine Hydrochloride) SS ORAL 20 MG ORALLY Ebixa (Ebixa /Den?) (Memantine Hydrochloride) SS ORAL 15 MG ORALLY Aricept (Aricept) (Donepezil Hydrochloride) SS ORAL 10 MG ORALLY Poly Karaya (Poly Karaya) () SS ORAL ORALLY 22-Feb-2006 08:20 AM Page: 1796 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Odrik (Odrik) (Trandolapril) SS Tahor (Tahor) (Atorvastatin Calcium) SS Risperdal (Risperdal) (Risperidone) SS Date:09/30/03ISR Number: 4203441-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030904585 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Foreign Risperidone PS ORAL 8 MG, IN 1 Health DAY, ORAL Professional Biperiden Hydrochloride (Biperiden Hyderochloride) C Famotidine (Famotidine) C Flunitrazepam (Flunitrazepam) C Date:09/30/03ISR Number: 4203779-7Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20030904593 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Foreign Risperdal Health (Risperidone) Professional Tablets PS ORAL 2 MG, ORAL Stilnoct (Zolpidem Tartrate) C Date:09/30/03ISR Number: 4203781-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030904112 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Risperdal Increased Health (Risperidone) Blood Uric Acid Increased Professional Unspecified PS 2 MG, 2 IN 1 White Blood Cell Count DAY Increased Taxilan (Perazine) C Aponal (Doxepin Hydrochloride) C Emla (Emla) C Date:10/01/03ISR Number: 4204187-5Report Type:Expedited (15-DaCompany Report #A02200302329 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Health Stilnox (Zolpidem) Initial or Prolonged Loss Of Consciousness Professional 10 Mg PS ORAL 5 MG OD Poly-Karaya (Karaya Gum/Polyvinylpolypyr rolidone) Granule SS ORAL 1 DF TID Pentasa "Ferring" 22-Feb-2006 08:20 AM Page: 1797 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Mesalazine) SS ORAL 2 G TID Deroxat (Paroxetne Hydrochloride) SS ORAL 10 MG OD Aricept (Donepezil Hydrochloride) 10 Mg SS ORAL 10 MG OD Memantine SS ORAL 15 MG OD Odrik (Trandolapril) SS ORAL Tahor (Atorvastatin Calcium) SS ORAL Risperdal (Risperidone) SS ORAL Date:10/01/03ISR Number: 4204780-XReport Type:Expedited (15-DaCompany Report #LBID00203002827 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Literature Lithium Carbonate Initial or Prolonged Increased Health (Lithium Carbonate) PS ORAL 450 MG BID PO 1 WK Aspartate Professional Risperidone Aminotransferase (Risperidone) SS ORAL DAILY PO 1 WK Increased Blood Albumin Decreased Blood Bilirubin Increased Blood Creatine Phosphokinase Increased Blood Creatinine Increased Blood Urea Increased Cerebral Atrophy Delirium Hallucination, Auditory Neuroleptic Malignant Syndrome Social Avoidant Behaviour White Blood Cell Count Increased Date:10/02/03ISR Number: 4204337-0Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20030602568 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Risperdal Circulatory Collapse Health (Risperidone) Condition Aggravated Professional Tablets PS ORAL 2 MG, ORAL Cyanosis (SEE IMAGE) Dysphagia Losec (Omeprazole) C Extrapyramidal Disorder Cipramil (Citalopram Fall Hydrobromide ) Heart Rate Irregular Tablets C Hypotension Akineton (Biperiden Loss Of Consciousness Hydrochloride) C Major Depression Musculoskeletal Stiffness Mutism Pulse Absent Salivary Hypersecretion Vertigo 22-Feb-2006 08:20 AM Page: 1798 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/03ISR Number: 4204343-6Report Type:Expedited (15-DaCompany Report #JP-36730 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Abortion Induced Foreign Risperdal Other Complications Of Maternal Health (Risperidone) PS UNKNOWN UNKNOWN Exposure To Therapeutic Professional Drugs Congenital Anomaly Maternal Drugs Affecting Foetus Date:10/02/03ISR Number: 4204347-3Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20030905313 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Foreign Risperdal Initial or Prolonged Phaeochromocytoma Health (Risperidone) PS UNKNOWN UNKNOWN Professional Company Representative Date:10/02/03ISR Number: 4204566-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030906075 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Risperdal (Risperidone) Tablets PS 2 MG, 1 IN 1 DAY Vasotec (Enalapril Maleate) C Date:10/03/03ISR Number: 4203917-6Report Type:Direct Company Report #CTU 203225 Age:5 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Dreams Risperdal Tablets Accidental Exposure 1mg PS 2 TABLETS Decreased Appetite Hypersomnia Medication Error Nervousness Pharmaceutical Product Complaint Tremor Trismus Date:10/03/03ISR Number: 4204018-3Report Type:Direct Company Report #CTU 203146 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersomnia Risperdal PS ORAL 1MG AM, 3MG Initial or Prolonged PM, PO Ambien 5mg Po SS ORAL PO Lisinopril C Toprol C Asa C 22-Feb-2006 08:20 AM Page: 1799 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vit E C Pravachol C Date:10/03/03ISR Number: 4204597-6Report Type:Expedited (15-DaCompany Report #2003039811 Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Lithium (Lithium) PS ORAL ORAL Drug Level Increased Health Paracetamol Professional (Paracetamol) SS ORAL ORAL Risperidone (Risperidone) SS ORAL ORAL Date:10/03/03ISR Number: 4204849-XReport Type:Direct Company Report #CTU 203221 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Risperdal 0.5mg Liver Function Test Janssen PS Janssen ORAL 0.5MG PO TID Abnormal Tegretol 100mg Udl SS Udl 100MG BID Date:10/06/03ISR Number: 4205151-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030802503 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Marrow Depression Foreign Risperidone Initial or Prolonged Feeling Abnormal Health (Risperidone) Other Myelodysplastic Syndrome Professional Unspecified PS ORAL 4 MG, 1 IN 1 DAY, ORAL Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) SS ORAL 8 MG, 1 IN 1, DAY, ORAL Sulpiride (Sulpiride) Unknown SS ORAL 150 MG, 1 IN 1 DAY, ORAL Quetiapine Fumarate (Quetiapine Fumarate) Tablets SS ORAL 100 MG, 1 IN 1 DAY, ORAL Flunitrazepam (Flunitrazepam) Unknown SS ORAL 2 MG, 1 IN 1 DAY, ORAL Quazepam (Quazepam) Unknown SS ORAL 30 MG, 1 IN 1 DAY, ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) Unknown SS ORAL 25 MG, 1 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1800 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/03ISR Number: 4205260-8Report Type:Expedited (15-DaCompany Report #APCDSS2003000151 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperidone Initial or Prolonged Flatulence Health (Risperidone) Hyperprolactinaemia Professional Tablets PS ORAL SEE IMAGE Nausea Biperiden Subileus Hydrochloride Vomiting (Biperiden Hydrochloride) Tablets C Candesartan Cilexetil 9candasartan Cilexetil) Tablets C Senna Extract 9senna Liquid Extract) Tablets C Haloperidol (Haloperidol) Unspecified C Levomepromazine Maleate(Levomepromaz ine Maleate) C Carbamazepine (Carbamazepine) Unknown C Date:10/06/03ISR Number: 4205262-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030906448 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Abortion Induced Foreign Risperdal Complications Of Maternal Health (Risperidone) Exposure To Therapeutic Professional Unspecified PS Drugs Maternal Drugs Affecting Foetus Multiple Congenital Abnormalities Date:10/06/03ISR Number: 4205263-3Report Type:Expedited (15-DaCompany Report #NZ-JNJFOC-20030906421 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Risperidone Initial or Prolonged Health (Risperidone) Professional Unspecified PS 1 MG, 2 IN 1 DAY Multiple Cardiac Medications (Cardiovascular System Drugs)Unknown C 22-Feb-2006 08:20 AM Page: 1801 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/03ISR Number: 4205265-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030905319 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Benign Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:10/06/03ISR Number: 4205266-9Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20030806152 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Risperdal Cardiomyopathy Health (Risperidone) Dilatation Atrial Professional Tablets PS ORAL 2 MG, 2 IN 1 Dilatation Ventricular DAY, ORAL Fatigue Epilim (Valproate Pulmonary Hypertension Sodium) Unknown SS 2000, MG, IN 1 DAY, UNKNOWN Lipitor (Unknown) Atorvastatin C Aspirin (Unknown) Acetylsalicylic Acid C Oroxine (Levothyroxine Sodium) Unknown C Date:10/06/03ISR Number: 4205616-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030906343 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Date:10/06/03ISR Number: 4205618-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030906140 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL Date:10/06/03ISR Number: 4205663-1Report Type:Expedited (15-DaCompany Report #2003039883 Age:17 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Sertraline Other Completed Suicide Health (Sertraline) PS ORAL ORAL Drug Level Increased Professional Risperidone Respiratory Arrest (Risperidone) SS ORAL ORAL Bupropion (Bupropion) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1802 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/03ISR Number: 4206817-0Report Type:Expedited (15-DaCompany Report #2003178439US Age:24 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Xanax Completed Suicide Health (Alprazolam) PS ORAL ORAL Overdose Professional Sequinan Respiratory Arrest (Risperidone) SS Maprotiline (Maprotiline) SS Date:10/07/03ISR Number: 4207600-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030906128 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Foreign Risperdal Initial or Prolonged Mutism Health (Risperidone) Professional Tablets PS ORAL 4 MG, 2 IN 1 DAY, ORAL Nozinan (Levomepromazine) C Dogmatil (Sulpiride) C Lexomil (Bromazepam) C Clopixol (Zuclopenthixol Decanoate) C Date:10/07/03ISR Number: 4207601-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030904667 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dermatitis Acneiform Foreign Risperdal Eye Oedema Health (Risperidone) PS ORAL 1 MG, 1 IN 1 Oedema Mouth Professional DAY, ORAL Oedema Peripheral Date:10/07/03ISR Number: 4207603-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030906219 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lipase Increased Foreign Risperdal Initial or Prolonged Health (Risperidone) Professional Tablets PS ORAL 8 MG, IN 1 DAY, ORAL Date:10/07/03ISR Number: 4207604-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030903002 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Foreign Risperidone - Initial or Prolonged Blood Lactate Study Blinded Dehydrogenase Increased Health (Risperidone) Condition Aggravated Professional Tablets PS 3 MG, 1 IN 1 Psychotic Disorder DAY Treatment Noncompliance Haldol (Haloperidol) SS ORAL 3 MG, 1 IN 1 DAY, ORAL Akineton (Biperiden Hydrochloride) 22-Feb-2006 08:20 AM Page: 1803 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablets C Date:10/07/03ISR Number: 4209571-1Report Type:Periodic Company Report #2002133121US Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Xanax(Alprazolam) Health Tablet PS ORAL ORAL Professional Risperidone(Risperid one) SS ORAL ORAL Aspirine(Acetylsalic ylic Acid) SS ORAL ORAL Date:10/08/03ISR Number: 4207203-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030804067 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, 2 IN 1 DAY, ORAL Vivactil (Protriptyline Hydrochloride) C Furosemide (Furosemide) C Isordil (Isosorbide Dinitrate) C Lorazepam (Lorazepam) C Ntg (Glyceryl Trinitrate) C Aspirin (Acetylsalicylic Acid) C Kcl (Potassium) C Date:10/08/03ISR Number: 4207204-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030601525 Age:12 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Health Risperdal Professional (Risperidone) PS Valproic Acid (Valproic Acid) C Ritalin (Methylphenidate Hydrochloride) C Date:10/08/03ISR Number: 4207205-3Report Type:Expedited (15-DaCompany Report #NSADSS2003022721 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal Professional (Risperidone) PS ORAL SEE IMAGE Company Zoloft (Sertraline Representative Hydrochloride) C Benadryl 22-Feb-2006 08:20 AM Page: 1804 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Diphenhydramine Hydrochloride) Tablets C Desyrel (Trazodone Hydrochloride) Tablets C Atarax (Hydroxyzine Hydrochloride) Tablets C Date:10/08/03ISR Number: 4207827-XReport Type:Direct Company Report #CTU 203463 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Extrapyramidal Disorder Risperidone 1 Mg PS ORAL 1/2 TAB QHS Intervention to ORAL Prevent Permanent Impairment/Damage Date:10/08/03ISR Number: 4207966-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030901094 Age:93 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Risperdal Initial or Prolonged Encephalopathy Health (Risperidone) Professional Unspecified PS ORAL 0.75 MG, 1 IN 1 DAY, ORAL Nolvadex (Tamoxifen) C Duphalac (Lactulose) C Amlor (Amlodipine Besilate) C Nitriderm (Glyceryl Trinitrate) C Coversyl (Perindopril) C Forlax (Macrogol) C Ostram (Calcium Phosphate) C Date:10/08/03ISR Number: 4207996-1Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20030904593 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diarrhoea Foreign Risperdal Hallucination, Visual Health (Risperidone) Overdose Professional Tablets PS ORAL 2 MG, 50 IN 1 Palpitations DAY, ORAL Suicide Attempt Stilnoct (Zolpidem Vomiting Tartrate) C Date:10/08/03ISR Number: 4207997-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030901126 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Road Traffic Accident Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Tercian 22-Feb-2006 08:20 AM Page: 1805 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Cyamemazine) C Lepticur (Tropatepine Hydrochloride) C Date:10/08/03ISR Number: 4208276-0Report Type:Direct Company Report #CTU 203467 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Risperidone PS Intervention to Amiodarone SS INTRAVENOUS 450 MG QOD Prevent Permanent INTRAVENOUS Impairment/Damage Date:10/09/03ISR Number: 4208016-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030705652 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Insomnia Foreign Risperidone Other Somnolence Health (Risperidone) Thrombocytopenia Professional Solution PS ORAL SEE IMAGE Imipenem Cilastatin Sodium (Imipenem) Injection SS Nitrazepam (Nitrazepam) C Date:10/09/03ISR Number: 4208315-7Report Type:Expedited (15-DaCompany Report #APCDSS2003000517 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperidone Health (Risperidone) Professional Tablets PS ORAL 4 MG, ORAL Haldol (Haloperidol) C Date:10/09/03ISR Number: 4208330-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031000012 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Gastric Ulcer Foreign Risperdal Gastritis Health (Risperidone) Melaena Professional Unspecified PS ORAL 5 MG, 1 IN 1 DAY, ORAL Cinnarizine (Cinnarizine) C Slo-Phyllin (Aminophylline) C Co-Amilofruse (Frumil) C Vitamine B Complex (B-Komplex "Leciva") C 22-Feb-2006 08:20 AM Page: 1806 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/09/03ISR Number: 4208432-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030800198 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Date:10/09/03ISR Number: 4208433-3Report Type:Expedited (15-DaCompany Report #NSADSS2003017817 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Perforation Health Risperdal Post Procedural Professional (Risperidone) Complication Tablets PS ORAL ORAL Date:10/09/03ISR Number: 4208434-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031000774 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Consumer Risperdal Dementia (Risperidone) Tardive Dyskinesia Tablets PS ORAL ORAL Date:10/09/03ISR Number: 4208745-3Report Type:Expedited (15-DaCompany Report #S03-USA-04093-01 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Lexapro Initial or Prolonged Pulmonary Embolism Professional (Escitalopram) PS ORAL 10 MG QD PO Lexapro (Escitalopram) SS ORAL 20 MG QD PO Lexapro (Escitalopram) SS ORAL 10 MG QD PO Risperdal (Risperidone) SS 2.5 MG QD Lithium SS 1500 MG QD Date:10/10/03ISR Number: 4209034-3Report Type:Direct Company Report #USP 080814 Age:5 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Ultram PS Mcneil TABLET Risperdal SS Janssen TABLET Date:10/10/03ISR Number: 4209115-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030904585 Age:30 YR Gender:Female I/FU:F Outcome PT Other Abdominal Pain Anaemia Condition Aggravated Erythema Extrapyramidal Disorder Granulocytopenia Hallucination, Auditory 22-Feb-2006 08:20 AM Page: 1807 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Rigidity Pancytopenia Purpura Report Source Product Role Manufacturer Route Dose Duration Pyrexia Foreign Risperidone Health (Risperidone) Professional Tablets PS ORAL SEE IMAGE Biperiden Hydrochloride (Biperiden Hydrochloride) Unknown C Famotidine (Famotidine) Unknown C Flunitrazepam (Flunitrazepam) Unknown C Etilerfrine Hydrochloride (Etilefrine Hydrochloride) Unknown C Serrapetase (Serrapeptase) Unknown C Zolpidem Tartrate (Zolpidem Tartrate) Unknown C Teprenone (Teprenone) Unknown C Loxoprofen Sodium (Loxoprofen Sodium) Unknown C Haloperidol (Haloperidol) Injection C Date:10/10/03ISR Number: 4209234-2Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20030804759 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis B Foreign Risperdal Consta Health (Risperidone) Professional Microspheres PS INJECTION Risperidone (Risperidone) Solutoin SS ORAL 3 MG, 1 IN 1 DAY, ORAL Panadeine (Panadeine Co) C Quetiapine (Quetiapine) Tablets C Lorazepam (Lorazepam) Tablets C Clonazepam/Haloperid ol (All Other Therapeutic Products) C 22-Feb-2006 08:20 AM Page: 1808 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/10/03ISR Number: 4209241-XReport Type:Expedited (15-DaCompany Report #NL-JNJFOC-20030802835 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Risperidone Cardiac Failure Acute Health (Risperidone) Drug Ineffective Professional Tablets PS 6 MG, IN 1 General Physical Health DAY Deterioration Risperdal Consta Overdose (Risperidone) Microspheres SS INTRAMUSCULAR INTRA-MUSCULA R Amlodipine (Amlodipine) SS 10 MG Date:10/10/03ISR Number: 4209306-2Report Type:Expedited (15-DaCompany Report #2003-DE-04462GD Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Literature Lithium Carbonate Initial or Prolonged Increased (Lithium Carbonate) PS 450 MG BID Aspartate Risperidone Aminotransferase (Risperidone) SS Increased Blood Albumin Decreased Blood Bilirubin Increased Blood Creatinine Increased Blood Pressure Increased Body Temperature Increased Cerebral Atrophy Delirium Depressed Level Of Consciousness Hallucination, Auditory Heart Rate Increased Lack Of Spontaneous Speech Muscle Contractions Involuntary Muscle Rigidity Neuroleptic Malignant Syndrome Tongue Disorder Tremor White Blood Cell Count Increased Date:10/10/03ISR Number: 4209832-6Report Type:Direct Company Report #USP 080735 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Reserpine PS TABLETS Risperdal SS Janssen TABLETS 22-Feb-2006 08:20 AM Page: 1809 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/14/03ISR Number: 4209872-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030802665 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Foreign Risperdal Initial or Prolonged Feeling Abnormal Health (Risperidone) Other Ill-Defined Disorder Professional Unspecified PS Company Representative Date:10/14/03ISR Number: 4210069-5Report Type:Direct Company Report #CTU 203743 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Risperdal 1mg PS ORAL 1 MG QHS Hospitalization - Syncope ORAL Initial or Prolonged Ventricular Arrhythmia Prozac C Required Ventricular Fibrillation Intervention to Prevent Permanent Impairment/Damage Date:10/14/03ISR Number: 4210072-5Report Type:Direct Company Report #CTU 203737 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperdal PS ORAL 2 PILLS Initial or Prolonged Delusion DAILY ORAL Date:10/14/03ISR Number: 4211852-2Report Type:Expedited (15-DaCompany Report #2002073197 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Zoloft (Sertraline) PS ORAL 150 MG Complications Of Maternal Health (DAILY), ORAL Exposure To Therapeutic Professional Alprazolam Drugs (Alprazolam) Maternal Drugs Affecting (Alprazolam) SS 6 MG (DAILY) Foetus Risperidone Pregnancy (Risperidone) SS 3 MG (DAILY), Propranolol (Propranolol) SS 40 MG (DAILY), Folic Acid (Folic Acid) SS Date:10/15/03ISR Number: 4209104-XReport Type:Direct Company Report #CTU 203900 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Rash Maculo-Papular Risperidone PS ORAL 2 DF DAILY PO Intervention to Treatment Noncompliance Tegretol SS ORAL 200 MG BID PO Prevent Permanent Risperdal C Impairment/Damage 22-Feb-2006 08:20 AM Page: 1810 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/03ISR Number: 4210394-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030802503 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypochromic Anaemia Foreign Risperidone Initial or Prolonged Myelodysplastic Syndrome Health (Risperidone) Other Professional Tablets PS ORAL 4 MG, IN 1 DAY, ORAL Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) Unknown SS ORAL 8 MG, 1 IN 1 DAY, ORAL Sulpiride (Sulpiride) Unknown SS ORAL 150 MG, 1 IN 1 DAY, ORAL Quetiapine Fumarate (Quetiapine Fumarate) Tablets SS ORAL 100 MG, 1 IN 1 DAY, ORAL Flunitrazepam (Flunitrazepam) Unknown SS ORAL 2 MG, 1 IN 1 DAY, ORAL Quazepam (Quazepam) Unknown SS ORAL 30 MG, 1 IN 1 DAY, ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) Unknown SS ORAL 25 MG, 1 IN 1 DAY, ORAL Date:10/15/03ISR Number: 4210587-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031000640 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucinations, Mixed Foreign Risperdal Initial or Prolonged Health (Risperidone) PS ORAL ORAL Professional Metoprolol (Metoprolol) C Aspirin (Acetylsalicylic Acid) C Atorvastatin (Atorvastatin) C Allopurinol (Allopurinol) C Lisinopril (Lisinopril) C Rofecoxib (Rofecoxib) C 22-Feb-2006 08:20 AM Page: 1811 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/03ISR Number: 4210590-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031001356 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Breast Neoplasm Foreign Risperdal Initial or Prolonged Fistula Health (Risperidone) PS ORAL 12 MG, 1 IN 1 Professional DAY, ORAL Tercian (Cyamemazine) C Depakote (Valproate Semisodium) C Date:10/15/03ISR Number: 4210594-7Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20030905382 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphemia Foreign Risperdal Dystonia Health (Risperidone) PS 2 MG, 1 IN 1 Professional DAY, Date:10/15/03ISR Number: 4210604-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031001217 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Foreign Risperdal Decreased Health (Risperidone) PS ORAL 2 MG, 1 IN 1 Professional DAY, ORAL Date:10/15/03ISR Number: 4210608-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031001180 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperidone Initial or Prolonged Fracture Health (Risperidone) Pyrexia Professional Tablets PS ORAL 2 MG, IN 1 DAY, ORAL Vegetamin-B (Vegetamin A) Tablets SS ORAL ORAL Fluvoxamine Maleate (Fluvoxamine Maleate) Tablets C Alprazolam (Alprazolam) Tablets C Triazolam (Triazolam) Tablets C Flunitrazepam (Flunitrazepam) C Date:10/15/03ISR Number: 4210612-6Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20030905313 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phaeochromocytoma Foreign Risperdal Initial or Prolonged Health (Risperidone) PS Professional Company Representative 22-Feb-2006 08:20 AM Page: 1812 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/03ISR Number: 4210669-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031001817 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL Date:10/15/03ISR Number: 4211189-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031001486 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Consumer Risperdal Initial or Prolonged Asthenia (Risperidone) Cardiac Disorder Tablets PS 0.5 MG - 4 MG Chest Pain DAILY Depression Disturbance In Attention Drug Withdrawal Syndrome Dyskinesia Euphoric Mood Feeling Abnormal Hypotension Muscle Twitching Nervousness Pigmentation Disorder Rectal Haemorrhage Vision Blurred Date:10/15/03ISR Number: 4211405-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031002035 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:10/15/03ISR Number: 4211407-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20031001878 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Fibrosis Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:10/15/03ISR Number: 4213570-3Report Type:Expedited (15-DaCompany Report #EMADSS2003003986 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Foreign Risperdal Alanine Aminotransferase Health (Risperidone) Increased Professional Tablets PS ORAL 1 MG, ORAL Aspartate Depamide Aminotransferase (Valpromide) C Increased Colitis Hepatic Enzyme Increased Splenomegaly 22-Feb-2006 08:20 AM Page: 1813 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/03ISR Number: 4213664-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031001180 Age:23 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperidone Initial or Prolonged Fracture Health (Risperidone) Pyrexia Professional Tablets PS ORAL 2 MG, IN 1 DAY, ORAL Vegetamin-B (Vegetamin A) Tablets SS ORAL ORAL Fluvoxamine Maleate (Fluvoxamine Maleate) Tablets C Alprazolam (Alprazolam) Tablets C Triazolam (Triazolam) Tablets C Flunitrazepam (Flunitrazepam) C Date:10/15/03ISR Number: 4213666-6Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20031000907 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Incontinence Foreign Risperdal Initial or Prolonged Urine Abnormality Health (Risperidone) PS ORAL 0.5 MG, ORAL Professional Lithionit (Lithium Sulfate) Tablets SS ORAL 42 MG, 4 IN 1 DAY, ORAL Ergenyl (Valproate Sodium) C Plendil (Felodipine) C Disipal (Orphenadrine Hydrochloride) C Haldol (Haloperidol) C Date:10/15/03ISR Number: 4214468-7Report Type:Expedited (15-DaCompany Report #03P-062-0235776-00 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Discomfort Foreign Akineton Initial or Prolonged Psychotic Disorder Health Retard(Akineton) Suicide Attempt Professional (Biperiden) (Biperiden) PS ORAL 4 MG, 1 IN 1 D, PER ORAL Perazine SS ORAL 100 MG, 10 IN 1 ONCE, PER ORAL Risperidone SS ORAL 1 TABLET, 1 IN 1 D, PER ORAL Melperone SS ORAL 25 MG, 2 IN 1 D, PER ORAL 22-Feb-2006 08:20 AM Page: 1814 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/16/03ISR Number: 4210759-4Report Type:Direct Company Report #CTU 204012 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Risperidone .5mg In Initial or Prolonged Somnolence Am And In Pm PS ORAL BID .5MG PO Date:10/17/03ISR Number: 4211278-1Report Type:Direct Company Report #CTU 204038 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ONLY ONE Date:10/17/03ISR Number: 4214151-8Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20030802961 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Parkinsonism Foreign Risperidone Initial or Prolonged Health (Risperidone) PS ORAL 1 MG, 1 IN 1 Professional DAY, ORAL Other Acetazolamide (Acetazolamide) SS 250 MG, 3 IN 1 DAY Selegiline (Selegiline) C Co-Careldopa (Sinemet) C Sertraline (Sertraline) C Acetazolamide (Acetazolamide) C Date:10/17/03ISR Number: 4214153-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030902049 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Foreign Risperdal Complications Of Maternal Health (Risperidone) PS ORAL 2 MG, 1 IN 1 Exposure To Therapeutic Professional DAY, ORAL Drugs Tranxene Maternal Drugs Affecting (Clorazepate Foetus Dipotassium) C Pregnancy Date:10/17/03ISR Number: 4214646-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904723 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Literature Risperdal Cardiac Arrest Health (Risperidone) Decerebration Professional Unspecified PS ORAL ORAL Eye Movement Disorder Distributor Paroxetine Hyperpyrexia (Paroxetine) SS Mental Status Changes Bupropion Multiple Drug Overdose (Bupropion) SS Muscle Rigidity Clonazepam Pyrexia (Clonazepam) SS 22-Feb-2006 08:20 AM Page: 1815 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/17/03ISR Number: 4214650-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031002361 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:10/17/03ISR Number: 4214652-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904792 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Literature Haldol (Haloperidol) Depressed Level Of Distributor Unspecified PS PARENTERAL PARENTERAL Consciousness Risperdal Electroencephalogram (Risperisone) SS PARENTERAL PARENTERAL Abnormal Valproic Acid SS PARENTERAL PARENTERAL Hallucination Hypotension Neuroleptic Malignant Syndrome Rhabdomyolysis Therapy Non-Responder Date:10/20/03ISR Number: 4212607-5Report Type:Direct Company Report #CTU 204149 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Risperdal 0.5mg PS ORAL 0.5MG Q6HR Initial or Prolonged Deep Vein Thrombosis PRN ORAL Depressed Level Of Colace C Consciousness Multivit C Demadex C Aricept C Ditropan C Macrodantin C Dulcolax C Norvasc C Pepcid C Imdur C Zoloft C Lovenox C Coumadin C Tylenol C Date:10/20/03ISR Number: 4214537-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030902920 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disorientation Health Risperdal Hospitalization - Fear Professional (Risperidone) Initial or Prolonged Memory Impairment Company Tablets PS ORAL 0.25 MG, 3 IN Neuroleptic Malignant Representative 1 DAY, ORAL Syndrome Potassium (Potassium Shock ) C West Nile Viral Infection Levothyroxine (Levothyroxine) C Metoprolol (Metoprolol) C 22-Feb-2006 08:20 AM Page: 1816 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Piperacillin (Piperacillin) C Tylenol (Paracetamol) C Date:10/20/03ISR Number: 4214578-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030701988 Age:79 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Consumer Risperdal Myocardial Infarction (Risperidone) Tablets PS 0.5 MG, 2 IN 1 DAY Date:10/20/03ISR Number: 4214580-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904720 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Risperdal Depressed Level Of Health (Risperidone) Consciousness Professional Unspecified PS ORAL ORAL Hypotension Distributor Valproic Acid Multi-Organ Failure (Valproic Acid) SS Tachycardia Clonazepam (Clonazepam) SS Atorvastatin (Atorvastatin) SS Gabapentin (Gabapentin) SS Clozapine (Clozapine) SS Nizatidine (Nizatidine) SS Trihexyphenidyl (Trihexyphenidyl) SS Date:10/20/03ISR Number: 4214697-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030802208 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Foreign Haldol (Haloperidol) PS Health Risperdal Professional (Risperidone) Tablets SS ORAL SEE IMAGE Date:10/20/03ISR Number: 4214705-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031002936 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL 0.5 MG, 1 IN 12 HOUR, ORAL 22-Feb-2006 08:20 AM Page: 1817 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/03ISR Number: 4214707-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031002590 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, 1 IN 24 HOUR, ORAL Date:10/20/03ISR Number: 4214752-7Report Type:Expedited (15-DaCompany Report #2003UW12627 Age:21 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pruritus Study Risperidone PS ORAL 2 DF DAILY PO Intervention to Rash Maculo-Papular Health Tegretol SS ORAL 200 MG BID PO Prevent Permanent Professional Risperdal C Impairment/Damage Date:10/20/03ISR Number: 4214899-5Report Type:Expedited (15-DaCompany Report #S03-FRA-04320-01 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Foreign Seropram (Citalopram Initial or Prolonged Extrapyramidal Disorder Health Hydrobromide) PS ORAL 20 MG QD PO Intestinal Obstruction Professional Risperdal Malnutrition Other (Risperidone) SS ORAL 1 MG QD PO Oedema Levothyrox Parkinsonism (Levothyroxine Self Esteem Decreased Sodium) C Date:10/20/03ISR Number: 4215506-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030802208 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Corticotrophin Foreign Haldol (Haloperidol) Decreased Health Unspecified PS Blood Prolactin Increased Professional Risperdal Pituitary Tumour (Risperidone) Tablets SS ORAL 0.5 & 1.5 & 2 MG, 2 IN 1 DAY, ORAL- SEE IMAGE Date:10/20/03ISR Number: 4215513-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031002061 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Foreign Risperdal Consta Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperidone (Risperidone) Unspecified SS ORAL 1 & 30 MG, 1 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1818 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Remergil Mirtazapine C Date:10/20/03ISR Number: 4215517-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031002350 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) Galactorrhoea Professional Tablets PS ORAL 3 & 5 MG, ORAL Carbamazepine (Carbamazepine) C Date:10/21/03ISR Number: 4216141-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031002862 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:10/21/03ISR Number: 4216247-3Report Type:Expedited (15-DaCompany Report #2003UW12931 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Seroquel PS ORAL 800 MG DAILY Professional PO Clozapine SS ORAL 400 MG DAILY PO Risperdal SS 4 MG BID Depakote SS 1500 MG DAILY Date:10/23/03ISR Number: 4215840-1Report Type:Direct Company Report #CTU 204460 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Risperidone PS ORAL 0.75 MG PO Q Initial or Prolonged Depressed Level Of AM AND 1 MG Q Consciousness 3 PM [RECENT] Klebsiella Infection Actonel C Lethargy Aricept C Mental Status Changes Ecasa C Sedation Eflone C Somnolence Synthroid C Urinary Tract Infection Reguloid C Seroquel C Timolol C Xalatan C Zooft C Alphagan C Calcium C 22-Feb-2006 08:20 AM Page: 1819 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/23/03ISR Number: 4217258-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031002035 Age:84 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS 0.5 MG, 1 IN 1 DAY Date:10/23/03ISR Number: 4217307-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031003238 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL Date:10/23/03ISR Number: 4217517-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031002349 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Risperdal Amenorrhoea Health (Risperidone) PS ORAL 6 MG, ORAL; 3 Bradycardia Professional MG, ORAL Condition Aggravated Haldol (Haloperidol) SS ORAL 12 MG, ORAL Delusion Ciatyl (Clopenthixol Extrapyramidal Disorder Hydrochloride) C Liver Function Test Tavor (Lorazepam) C Abnormal Seroquel (Quetiapine Psychotic Disorder Fumarate) C Date:10/23/03ISR Number: 4217521-7Report Type:Expedited (15-DaCompany Report #EMADSS2003001129 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Increased Foreign Risperdal Initial or Prolonged Epistaxis Health (Risperidone) PS ORAL 3 MG, ORAL Headache Professional Tercain Hyperaldosteronism (Cyamemazine) Hypoaesthesia Solution SS ORAL 45 MG, ORAL; Phosphenes 25 MG, ORAL Renal Atrophy Deroxat (Paroxetine Renin Increased Hydrochloride) SS ORAL 20 MG, ORAL Tachycardia Tremor Date:10/24/03ISR Number: 4219995-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031003247 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aphagia Consumer Risperdal Other Coma (Risperidone) Tablets PS ORAL 2 MG, IN 1 DAY, ORAL Haldol (Haloperidol) Unspecified SS 22-Feb-2006 08:20 AM Page: 1820 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/03ISR Number: 4219998-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20031003648 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Health Risperdal Initial or Prolonged Blood Prolactin Increased Professional (Risperdone) Tablets PS ORAL 3 MG, 1 IN 1 Retrograde Ejaculation DAY, ORAL Date:10/24/03ISR Number: 4220000-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031003641 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dry Skin Consumer Risperdal Initial or Prolonged Dyspnoea (Risperidone) Rash Generalised Tablets PS ORAL 4 MG, 1 IN 1 Tremor DAY, ORAL Haldol Decanoate (Haloperidol Decanoate) Injection SS INITIATED 2 YEARS-AGO, FOR APPROXIMATELY 8 MONTHS Date:10/24/03ISR Number: 4220004-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031003649 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS 4 MG, 2 IN 1 DAY, UNKNOWN Clozapine (Clozapine) SS 400 MG, 1 IN 1 DAY Depakote (Valproate Semisodium) SS 1500 MG, 1 IN 1 DAY Seroquel (Quetiapine Fumarate) SS 800 MG, 1 IN 1 DAY Date:10/24/03ISR Number: 4220097-1Report Type:Expedited (15-DaCompany Report #2003111286 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Atarax (Tablet) Initial or Prolonged Agitation Health (Hydroxyzine Bladder Distension Professional Hydrochloride) PS ORAL 100 MG (TID), Dementia ORAL Disorientation Ferrous Sulfate Dyskinesia (Ferrous Sulfate) SS ORAL ORAL Hypertonia Madopar (Levodopa, Pyrexia Benserazide Somnolence Hydrochloride) SS ORAL 500 MG (DAILY), ORAL Risperidone (Risperidone) SS ORAL 1 MG (DAILY), ORAL 22-Feb-2006 08:20 AM Page: 1821 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/03ISR Number: 4220184-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031003789 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ketoacidosis Foreign Risperidone Health (Risperidone) PS ORAL 6 MG, IN 1 Professional DAY, ORAL Date:10/24/03ISR Number: 4220185-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031003790 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemolytic Anaemia Foreign Risperidone Health (Risperidone) PS ORAL ORAL Professional Date:10/24/03ISR Number: 4220186-1Report Type:Expedited (15-DaCompany Report #APCDSS2002001344 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal White Blood Cell Count Health (Risperidone)Tablets PS ORAL 2 MG, IN 1 Decreased Professional DAY, ORAL Date:10/24/03ISR Number: 4220188-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031001217 Age:92 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Neutropenia Health (Risperidone) PS ORAL 2 MG, 1 IN 1 Professional DAY, ORAL Kardegic (Acetylsalicylate Lysine) C Zoloft (Sertraline Hydrochloride) C Hemigoxine (Digoxin) C Pariet (Rabeprazole Sodium) C Date:10/27/03ISR Number: 4220617-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031003644 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Risperdal White Blood Cell Count Professional (Risperidone) PS Decreased Clozapine (Clozapine) SS 100 - 425 MG DAILY Protonix (Pantoprazole) SS Lamotrigine (Lamotrigine) SS Klonopin (Clonazepam) SS Cogentin (Benzatropine Mesilate) C 22-Feb-2006 08:20 AM Page: 1822 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoloft (Sertraline Hydrochloride) C Date:10/27/03ISR Number: 4220619-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031004577 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Decreased Consumer Risperdal Initial or Prolonged Muscle Twitching (Risperidone) PS ORAL ORAL Tremor Exelon (Rivastigmine Tartrate) C Antihypertensives (Antihypertensives) C Date:10/27/03ISR Number: 4221257-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030901698 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Ischaemic Stroke Foreign Risperdal Hospitalization - Health (Risperidone) Initial or Prolonged Professional Tablets PS ORAL 0.25 MG, 2 IN Other 1 DAY, ORAL Lorazepam (Lorazepam) C Zyprexa (Olanzapine) C Ass (Acetylsalicylic Acid) C Tavanic (Levofloxacin) C Stangyl (Trimipramine Maleate) C Pantozol (Pantoprazole Sodium) C Clexane (Heparin-Fraction, Sodium Salt) C Date:10/28/03ISR Number: 4220523-8Report Type:Direct Company Report #CTU 204686 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Risperidone PS 2 MG HS Initial or Prolonged Date:10/28/03ISR Number: 4222392-9Report Type:Expedited (15-DaCompany Report #03P-056-0236204-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypothermia Foreign Depakote Tablets Intervention to Neutropenia Health (Depakote) Prevent Permanent Professional (Divalproex Sodium) Impairment/Damage (Divalproex Sodium) PS ORAL 1000 MG, 1 IN 1 D, PER ORAL 22-Feb-2006 08:20 AM Page: 1823 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperidone SS ORAL PER ORAL Levomepromazine SS Alimemazine Tartrate SS Diazepam SS Oxazepam C Date:10/28/03ISR Number: 4222397-8Report Type:Expedited (15-DaCompany Report #03P-167-0225165-00 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Increased Foreign Epilim (Depakene) Intervention to Coma Health (Valproic Acid) Prevent Permanent Complex Partial Seizures Professional (Valproic Acid) PS ORAL 200 MG, 2 IN Impairment/Damage Conversion Disorder 1 D, PER ORAL Dystonia Risperidone SS ORAL 2 MG, 1 IN 1 D, PER ORAL Date:10/28/03ISR Number: 4222874-XReport Type:Expedited (15-DaCompany Report #2003AP03281 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Fluctuation Foreign Seroquel PS ORAL 25 MG TID PO Blood Glucose Increased Health Wintermin SS ORAL 62.5 MG DAILY Cardio-Respiratory Arrest Professional PO Cerebral Haemorrhage Other Wintermin SS ORAL 25 MG DAILY Clostridium Colitis PO Generalised Oedema Serenace SS 0.75 MG TID Haemorrhage Subcutaneous UNK Haemorrhagic Diathesis Serenace SS Hepatic Function Abnormal Risperdal SS ORAL 1 MG TID PO Hernia Seven Ep C Herpes Zoster Hypoglycaemia Hypoproteinaemia Hypothyroidism Immunosuppression Oral Candidiasis Pneumonia Pupils Unequal Thrombocytopenic Purpura Urinary Tract Infection Date:10/28/03ISR Number: 4222934-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030902049 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Risperdal Complications Of Maternal Health (Risperidone) Exposure To Therapeutic Professional Tablets PS ORAL 2 MG, 1 IN 1 Drugs DAY ORAL Maternal Drugs Affecting Tranxene Clorazepate Foetus Dipotassium C Pregnancy 22-Feb-2006 08:20 AM Page: 1824 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/03ISR Number: 4222937-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031003882 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Risperdal Complications Of Maternal Health (Risperidone) PS Exposure To Therapeutic Professional Drugs Maternal Drugs Affecting Foetus Date:10/28/03ISR Number: 4222939-2Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20030801946 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Electrocardiogram Qt Health (Risperidone) PS ORAL 2 MG ORAL Corrected Interval Professional Dominal Prolonged (Prothipendyl Hypokalaemia Hydrochloride) SS 40 MG Ventricular Extrasystoles Zestril (Lisinopril) C Amlor (Amlodipine Besilate) C Kalium Durettes (Potassium Chloride) C Date:10/29/03ISR Number: 4222084-6Report Type:Direct Company Report #CTU 204828 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dystonia Haliperidol PS Respiridal SS Date:10/29/03ISR Number: 4223367-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030701745 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal Pneumonia Professional (Risperidone) PS Date:10/29/03ISR Number: 4223368-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031005057 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Health Risperdal Professional (Risperidone) Unspecified PS Date:10/29/03ISR Number: 4223676-0Report Type:Expedited (15-DaCompany Report #KII-2003-0004111 Age:55 YR Gender:Female I/FU:I Outcome PT Hospitalization - Anticonvulsant Drug Level Initial or Prolonged Below Therapeutic Other Aphasia Blood Pressure Increased Confusional State 22-Feb-2006 08:20 AM Page: 1825 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Increased Hypoventilation Intentional Overdose Report Source Product Role Manufacturer Route Dose Duration Intentional Self-Injury Health Oxycontin Lethargy Professional Tablets(Oxycodone Loss Of Consciousness Hydrochloride) Cr Miosis Tablet PS ORAL ORAL Moaning Demerol (Pethidine Multiple Drug Overdose Hydrochloride) SS Productive Cough Baclofen (Baclofen) SS Pulmonary Oedema Risperdal(Risperidon Respiratory Rate e) SS Increased Dilantin (Phenytoin Somnolence Sodium) SS Toxicologic Test Abnormal Soma(Carisoprodol) SS Methadone(Methadone) SS Date:10/29/03ISR Number: 4223705-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031003825 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nephritis Interstitial Foreign Risprdal Health (Risperidone) PS ORAL 2 MG, IN 1 Professional DAY, ORAL Date:10/29/03ISR Number: 4223710-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030900027 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risprdal Other Health (Risperidone) PS 1 MG, IN 1 Professional DAY Date:10/29/03ISR Number: 4223716-9Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20030707073 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiogenic Shock Foreign Risprdal Life-Threatening Coma Health (Risperidone) PS ORAL 0.5 MG, ORAL Hyperthermia Malignant Professional Topamax (Topiramate) Pleural Effusion Other Unspecified C Pulmonary Oedema Quadriparesis Date:10/29/03ISR Number: 4223722-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031003844 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Neutropenia Health (Risperidone) PS ORAL 8 MG, 1 IN 1 Professional DAY, ORAL 22-Feb-2006 08:20 AM Page: 1826 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/30/03ISR Number: 4223796-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031005380 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, IN 1 DAY, ORAL Date:10/30/03ISR Number: 4223810-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031005043 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 2 MG, 3 IN 1 DAY, ORAL Date:10/30/03ISR Number: 4223812-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031005039 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Huntington'S Chorea Consumer Risperdal Respiratory Failure (Risperidone) Tablets PS ORAL ORAL Date:10/30/03ISR Number: 4223880-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031004681 Age:5 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Literature Risperidone Initial or Prolonged Mental Status Changes Health (Risperidone) Professional Tablets PS ORAL 5 MG ORAL Date:10/30/03ISR Number: 4224000-XReport Type:Expedited (15-DaCompany Report #S03-GER-04403-01 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Toxicity Foreign Cipramil (Citalopram Nephritis Interstitial Health Hydrobromide) PS ORAL 40 MG QD PO Renal Tubular Disorder Professional Risperdal Other (Risperidone) SS Eunerpan (Melperone Hydrochloride) SS Seroquel (Quetiapine Fumarate) SS Date:10/30/03ISR Number: 4224022-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031004593 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Visual Foreign Risperdal Initial or Prolonged Mental Impairment Health (Risperidone) Disability Urinary Incontinence Professional Unspecified PS ORAL SEE IMAGE Zispin (Mirtazapine) C Amitriptyline (Amitriptyline) C 22-Feb-2006 08:20 AM Page: 1827 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chlorpromazine (Chlorpromazine) C Lorazepam (Lorazepam) C Date:10/31/03ISR Number: 4224809-2Report Type:Expedited (15-DaCompany Report #K200301720 Age:19 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Drug Reaction Literature Haloperidol Health Decanoate PS PARENTERAL PARENTERAL Professional Risperidone (Risperidone) SS PARENTERAL PARENTERAL Valproic Acid (Valproic Acid) SS PARENTERAL PARENTERAL Date:10/31/03ISR Number: 4225007-9Report Type:Expedited (15-DaCompany Report #FI-JNJFOC-20031004204 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Risperidone) Professional Tablets PS ORAL 2 MG, IN 1 DAY, ORAL Imovane (Zopiclone) Tablets C Temesta (Lorazepam) Tablets C Date:10/31/03ISR Number: 4225245-5Report Type:Expedited (15-DaCompany Report #KII-2003-0003497 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Decreased Health Oxycontin Initial or Prolonged Medication Error Professional Tablets(Oxycodone Other Sedation Hydrochloride) Cr Somnolence Tablets PS ORAL 20 MG, SINGLE,ORAL Ambien (Zolpidem Tartrate) SS ORAL 10 MG, SINGLE, ORAL Xanax (Alprazolam) SS ORAL 0.25 MG, SINGLE, ORAL Prevacid (Lansoprazole) SS ORAL 15 MG, SINGLE, ORAL Azulfidine (Sulfasalazine) SS ORAL 500 MG, SINGLE, ORAL Reglan (Metoclopramide) SS ORAL 10 MG, SINGLE, ORAL Risperdal (Risperidone) SS ORAL 0.5 MG, SINGLE, ORAL 22-Feb-2006 08:20 AM Page: 1828 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4224555-5Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0312701A Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Restless Legs Syndrome Deroxat PS Glaxosmithkline ORAL 40MG Per day Initial or Prolonged Restlessness Risperdal SS ORAL Anxiolytic C UNKNOWN Sedatif Pc C UNKNOWN Date:11/03/03ISR Number: 4226317-1Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20031005115 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Acute Foreign Risperdal Weight Decreased Health (Risperidone) Professional Unspecified PS RECEIVED FOR 1-2 WEEKS Temesta (Lorazepam) C Date:11/03/03ISR Number: 4226318-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031005106 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Risperdal Complications Of Maternal Health (Risperidone) Exposure To Therapeutic Professional Unspecified PS ORAL ORAL Drugs Maternal Drugs Affecting Foetus Pregnancy Date:11/03/03ISR Number: 4226319-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031004839 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ear Malformation Foreign Risperdal Initial or Prolonged Facial Dysmorphism Health (Risperidone) Maternal Drugs Affecting Professional Unspecified PS INTRA-UTERINE 1 MG , 1 IN 1 Foetus DAY, Oesophageal Atresia INTRA-UTERNIN E Lepticur (Tropatepine Hydrochloride) C Tranxene (Clorazepate Dipotassium) C Subutex (Buprenorphine Hydrochloride) C Largactil (Chlorpromazine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1829 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/03ISR Number: 4226320-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030904585 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Risperidone Drug Effect Decreased Health (Risperidone) Extrapyramidal Disorder Professional Tablets PS ORAL SEE IMAGE Granulocytopenia Famotidine Hypersensitivity (Famotidine) Unknown SS ORAL 20 MG, IN 1 Muscle Rigidity DAY, ORAL Pancytopenia Biperiden Pyrexia Hydrochloride C Flunitrazepam C Etilerfrine Hydrochloride C Serrapetase (Serrapeptase) C Zolpidem Tartrate C Teprenone C Loxoprofen Sodium C Haloperidol C Date:11/03/03ISR Number: 4226322-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031005402 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Foreign Risperdal Initial or Prolonged Health (Risperidone) Professional Solution PS ORAL 0.5 ML, 1 IN 1 DAY, ORAL Dipiperon (Pipamperone) Solution SS ORAL 5 ML, 2 IN 1 DAY, ORAL Actrapid Human (Insulin Human) C Prolaphan (Prolactine Inhibitors) C Amaryl (Aquaphor) C Capto-Isis (Captopril) C Digitoxin C Isoket Retard (Isosorbide Dinitrate) C Zyloric (Allpurinol) C Date:11/03/03ISR Number: 4226617-5Report Type:Expedited (15-DaCompany Report #03P-087-0238185-00 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Akineton (Biperiden) Initial or Prolonged Fall Health (Biperiden) PS ORAL PER ORAL Haemodialysis Professional Risperidone SS ORAL PER ORAL Renal Failure Acute Haloperidol SS ORAL PER ORAL Rhabdomyolysis Phenothiazine SS ORAL PER ORAL Amantadine Hydrochloride SS ORAL PER ORAL Flunitrazepam SS 22-Feb-2006 08:20 AM Page: 1830 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dantrolene Sodium C Date:11/03/03ISR Number: 4227000-9Report Type:Expedited (15-DaCompany Report #2003-DE-05474GD Age:21 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Lithium Carbonate ( Multiple Drug Overdose Lithium Carbonate) PS ORAL PO Paracetamol (Paracetamol) SS ORAL PO Risperidone (Risperidone) SS ORAL PO Date:11/04/03ISR Number: 4227466-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031005437 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Urea Decreased Foreign Risperdal C-Reactive Protein Health (Risperidone) PS ORAL 0.5 MG, 1 IN Increased Professional 1 DAY, ORAL Death Depamide General Physical Health (Valpromide) C Deterioration Hepatocellular Damage Date:11/04/03ISR Number: 4227500-1Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20031004532 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal Erythropenia Health (Risperidone) PS ORAL SEE IMAGE, Leukopenia Professional ORAL Zyprexa (Olanzapine) SS SEE IMAGE Combivir (Zidovudine W/Lamivudine) SS 300 MG Viracept (Nelfinavir Mesilate C Date:11/04/03ISR Number: 4227700-0Report Type:Direct Company Report #CTU 205240 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Risperidone PS 0.5 MG BID Increased Heart Rate Increased Hyperhidrosis Neuroleptic Malignant Syndrome Postoperative Infection Date:11/04/03ISR Number: 4227703-6Report Type:Direct Company Report #CTU 205237 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Risperdal PS ORAL 1 MG PO QD Lamictal SS 300 MG BID 22-Feb-2006 08:20 AM Page: 1831 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dilantin C Date:11/05/03ISR Number: 4227721-8Report Type:Direct Company Report #CTU 205297 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Body Temperature Aripiprazole PS ORAL 30 MG DAILY Intervention to Increased ORAL Prevent Permanent Extrapyramidal Disorder Risperidone SS ORAL 6 MG DAILY Impairment/Damage Eye Disorder ORAL Eye Movement Disorder Zolpidem C Muscle Rigidity Bupropion C Lorazepam C Trazadone C Date:11/05/03ISR Number: 4227774-7Report Type:Direct Company Report #CTU 205251 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Risperidone PS Initial or Prolonged Syndrome Date:11/05/03ISR Number: 4228677-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031005795 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Neutropenia Health (Risperidone) Professional Tablets PS ORAL SEE IMAGE Date:11/05/03ISR Number: 4228735-4Report Type:Expedited (15-DaCompany Report #NSADSS2002041916 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Consumer Risperdal Hospitalization - Cerebral Infarction (Risperidone) Initial or Prolonged Cerebrovascular Disorder Unspecified PS ORAL SEE IMAGE Required Coronary Artery Lanoxin (Digoxin) C Intervention to Atherosclerosis Serzone (Nefazodone Prevent Permanent Dyskinesia Hydrochloride) C Impairment/Damage Lethargy Insulin (Insulin) C Myocardial Fibrosis Trental Pneumonia Aspiration (Pentoxifylline) C Pseudomonas Infection Ditropan Pyrexia (Oxybutynin) C Urinary Tract Infection Antivert (Ancovert) C Ritalin (Methylphenidate Hydrochloride) C Florinef (Fludrocortisone Acetate) C Ultram (Tramadol Hydrochloride) C Parlodel (Bromocriptine Mesilate) C 22-Feb-2006 08:20 AM Page: 1832 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Corgard (Nadolol) C Claritin (Loratadine) C Glucotrol (Glipiazide) C Lomotil (Lomotil) C Date:11/06/03ISR Number: 4230409-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031100288 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diarrhoea Haemorrhagic Consumer Risperdal Fall (Risperidone) Femur Fracture Tablets PS ORAL 0.25 MG, 1 IN 1 DAY, ORAL Date:11/06/03ISR Number: 4230563-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031001180 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperidone Initial or Prolonged Eating Disorder Health (Risperidone) Implant Site Reaction Professional Tablets PS OPHTHALMIC 2 MG, IN 1 Insomnia DAY, ORAL Irritability Vegetamin-B Lumbar Vertebral Fracture (Vegetamin A) Pyrexia Tablets SS ORAL 1 DOSE(S), IN Restlessness 1 DAY, ORAL Vomiting Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) SS Levomepromazine Maleate SS ORAL 2 MG, IN 1 DAY, ORAL Levomepromazine Maleate (Levomepromazine Maleate) SS ORAL 25 MG, IN 1 DAY, ORAL Levomepromazine Maleate (Levomepromazine Maleate) SS ORAL 50 MG, IN 1 DAY, ORAL Fluvoxamne Maleate (Fluvoxamine Maleate) Tablets C Alprazolam (Alprazolam) Tablets C Triazolam (Triazolam) Tablets C Flunitrazepam (Flunitrazepam) C Sodium Ferrous Citrate (Sodiumferedetate) C Epinastine Hydrochloride 22-Feb-2006 08:20 AM Page: 1833 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Epinastine Hydrochloride) C Perospirione Hydrochlordie Hydrate (All Other Therpeutic Products) C Date:11/06/03ISR Number: 4230567-8Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20031004169 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Risperdal Prolonged Health (Risperidone) Fatigue Professional Unspecified PS 0.5 MG, 1 IN Sinus Bradycardia 1 DAY Date:11/07/03ISR Number: 4229154-7Report Type:Direct Company Report #CTU 205511 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Risperidone 4 Mg Initial or Prolonged Mental Status Changes Tablets PS ORAL 2 MG HS ORAL Trazodone C Risperidone C Bactrim C Felodi C Fluconazole C Date:11/07/03ISR Number: 4229169-9Report Type:Direct Company Report #CTU 205507 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Risperidal 2 Mg Initial or Prolonged Janssen PS Janssen ORAL 2MG BID PO Prevacid C Cogentin C Zyprexa C Date:11/07/03ISR Number: 4229224-3Report Type:Direct Company Report #CTU 205500 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Abnormal Risperdal 2 Mg Pharmaceutical Product Janssen PS Janssen 2 MG ONCE A Complaint DAY Date:11/07/03ISR Number: 4229246-2Report Type:Direct Company Report #CTU 205506 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Resperdal PS Influenza Like Illness Remeron SS Mental Status Changes 22-Feb-2006 08:20 AM Page: 1834 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/03ISR Number: 4229902-6Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0389197A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Ineffective Wellbutrin PS Glaxosmithkline ORAL 400MG Per day 7 YR Drug Interaction Tegretol SS UNKNOWN Risperdal SS UNKNOWN Klonopin C UNKNOWN Date:11/07/03ISR Number: 4229961-0Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0390959A Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Weight Increased Wellbutrin PS Glaxosmithkline ORAL 150MG In the morning 2 MON Risperidal SS UNKNOWN 3MG per day Date:11/07/03ISR Number: 4231397-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030706206 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Consumer Duragesic (Fentanyl) Increased Health Patch PS TRANSDERMAL SEE IMAGE Convulsion Professional Risperdal Drug Effect Decreased (Risperidone) Drug Withdrawal Syndrome Tablets SS ORAL 1 IN 1 DAY, Fatigue ORAL Loss Of Consciousness Protonix (Pantoprazole) C Norco (Vicodin) C Prozac (Fluoxetine Hydrochloride) C Date:11/07/03ISR Number: 4231472-3Report Type:Expedited (15-DaCompany Report #NSADSS2003021385 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Risperdal Professional (Risperidone) Tablets PS ORAL 3 MG, ORAL Olanzapine (Olanzapine) C Benztropine (Benzatropine Mesilate) C Date:11/07/03ISR Number: 4231474-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031001817 Age:87 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL 1 MG, 1 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1835 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/03ISR Number: 4231481-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030706206 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Diragesic (Fentanyl) Body Temperature Health Patch PS TRANSDERMAL SEE IMAGE Increased Professional Risperdal Convulsion (Risperidone)Tablets SS ORAL 1 IN 1 DAY, Drug Effect Decreased ORAL Drug Withdrawal Syndrome Protonix Fatigue (Pantoprazole) C Loss Of Consciousness Norco (Vicodin) C Nervousness Prozac (Fluoxetine Hydrochloride) C Date:11/07/03ISR Number: 4231595-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030904282 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Feeling Abnormal Foreign Risperdal ( Initial or Prolonged Pharyngeal Oedema Health Risperidone) PS 6 MG Swollen Tongue Professional Other Date:11/07/03ISR Number: 4231598-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030705967 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Foreign Risperdal Health (Risperidone) PS THE PATIENT Professional DID NOT Other RECEIVE ANY RISPERIDONE Date:11/07/03ISR Number: 4232063-0Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0313068A Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Deroxat PS Glaxosmithkline ORAL Somnolence Risperdal SS ORAL Date:11/10/03ISR Number: 4233485-4Report Type:Expedited (15-DaCompany Report #2003PK01801 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephritis Interstitial Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Normochromic Normocytic Health PO Required Anaemia Professional Risperidon SS ORAL 4 MG DAILY PO Intervention to Renal Tubular Disorder Other Melperon SS ORAL 25 MG DAILY Prevent Permanent PO Impairment/Damage Citalopram SS ORAL 40 MG DAILY PO 22-Feb-2006 08:20 AM Page: 1836 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/11/03ISR Number: 4232780-2Report Type:Direct Company Report #CTU 205772 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Risperdal PS ORAL 1 MG PO QD Lamictal SS 300 MG BID Dilantin C Date:11/12/03ISR Number: 4235202-0Report Type:Expedited (15-DaCompany Report #03P-167-0225165-00 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Pressure Increased Foreign Epilim (Depakene) Intervention to Coma Health (Valproic Acid) Prevent Permanent Complex Partial Seizures Professional (Valproic Acid) PS ORAL 200 MG, 2 IN Impairment/Damage Dystonia 1 D, PER ORAL Risperidone SS Date:11/12/03ISR Number: 4235243-3Report Type:Expedited (15-DaCompany Report #FRWYE382803NOV03 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchial Obstruction Foreign Seresta (Oxazepam, Initial or Prolonged Cholestasis Health Tablet) PS ORAL 45 MG DAILY Somnolence Professional ORAL Other Risperdal (Risperidone, ,0) SS ORAL 1 MG 2X PER 1 DAY ORAL Aricept (Donepezil Hydrochloride) C Stablon (Tianeptine) C Kardegic (Acetylsalicylate Lysine) C Date:11/13/03ISR Number: 4235452-3Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20031100892 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Risperdal Initial or Prolonged Bronchospasm Study (Risperidone) Other Cellulitis Health Unspecified PS ORAL 4 MG, IN 1 Loss Of Consciousness Professional DAY , ORAL Metabolic Acidosis Lithium (Lithium) C Myositis Lorazepam Renal Failure Acute (Lorazepam) C Thrombocytopenia Flurazepam Toxic Shock Syndrome (Flurazepam) C Streptococcal Amitriptyline White Blood Cell Count (Amitriptyline) C Increased Date:11/13/03ISR Number: 4235455-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031006567 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Foreign Risperdal Consumer (Risperidone) 22-Feb-2006 08:20 AM Page: 1837 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unspecified PS ORAL 2 MG, ORAL Date:11/13/03ISR Number: 4235885-5Report Type:Expedited (15-DaCompany Report #KII-2003-0003077 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Study Hydrocodone Initial or Prolonged Fall Health Bitartrate (Similar Other Head Injury Professional To Inda Hypotension Other 59,175)(Hydrocodone Lethargy Bitartrate) Unknown PS Multiple Drug Overdose Paxil(Paroxetine Suicide Attempt Hydrochloride) SS Vomiting Celexa(Citalopram Hydrobromide) SS Trazodone(Trazodone) SS Protonix(Pantoprazol e) SS Risperidone(Risperid one) SS Ativan(Lorazepam) SS Acetaminophen(Parace tamol) SS Date:11/13/03ISR Number: 4235902-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030706436 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Facial Bones Fracture Foreign Risperdal Grand Mal Convulsion Health (Risperidone) Skin Laceration Professional Tablets PS ORAL 6 MG, ORAL Leponex (Clozapine) Tablets SS ORAL 25 MG, ORAL Zyprexa (Olanzapine) Tablets SS ORAL 20 MG, ORAL Cipramil (Citalopram Hydrobromide) Tablets SS ORAL 20 MG, ORAL Bronchoretard (Theophylline) C Berotec (Fenoterol Hydrobromide) Spray C Pulmicort (Budesonide) Spray C Date:11/13/03ISR Number: 4235922-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031100981 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, 1 IN 12 HOURS, ORAL 22-Feb-2006 08:20 AM Page: 1838 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/03ISR Number: 4235924-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030906140 Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, 2 IN 1 DAY, ORAL Haldol (Haloperidol) C Cogentin (Benzatropine Mesilate) C Date:11/13/03ISR Number: 4235927-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030901230 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Risperdal Respiratory Failure Professional (Risperidone) Tablets PS ORAL ORAL Date:11/13/03ISR Number: 4235931-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030802485 Age:89 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:11/13/03ISR Number: 4235933-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030705062 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL Date:11/13/03ISR Number: 4236030-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031101049 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Consumer Risperdal Health (Risperidone) Professional Unspecified PS Date:11/13/03ISR Number: 4236031-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031101044 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 1 MG, 2 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1839 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/13/03ISR Number: 4236032-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031101036 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Consumer Risperdal Convulsion (Risperidone) Tablets PS ORAL ORAL Date:11/14/03ISR Number: 4236402-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031101047 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dementia Consumer Risperdal Initial or Prolonged Transient Ischaemic (Risperidone) Attack Unspecified PS Tremor Date:11/14/03ISR Number: 4236414-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031102009 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Amylase Increased Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Concerta (Methylphenidate Hydrochloride) C Zyrtec (Cetirizine Hydrochloride) C Date:11/14/03ISR Number: 4236419-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031101050 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Unspecified PS Date:11/14/03ISR Number: 4236422-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031101850 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Company Unspecified PS Representative Date:11/14/03ISR Number: 4236450-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031000986 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Keratitis Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, 2 IN 1 DAY, ORAL Depakote Er 22-Feb-2006 08:20 AM Page: 1840 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Vlproate Semisodium) C Wellbutrin (Bupropion Hydrochloride) C Seroquel (Quetiapine Fumarate) C Date:11/14/03ISR Number: 4236541-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030905319 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Adenoma Benign Foreign Risperdal Alanine Aminotransferase Health (Risperidone) Increased Professional Unspecified PS ORAL SEE IMAGE Amenorrhoea Other Aspartate Aminotransferase Increased Breast Disorder Galactorrhoea Gamma-Glutamyltransferase Increased Hyperprolactinaemia Pituitary Tumour Benign Prolactinoma Date:11/14/03ISR Number: 4236563-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031003825 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Foreign Risperdal Increased Health (Risperidone) PS ORAL 4 MG, IN 1 Nephritis Interstitial Professional DAY, ORAL Normochromic Normocytic Other Quetiapine Anaemia (Quetiapine) C Red Blood Cell Melperon (Melperon) C Sedimentation Rate Citalopram Increased (Citalopram) C Renal Tubular Disorder Date:11/14/03ISR Number: 4236618-9Report Type:Expedited (15-DaCompany Report #2003GB02985 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cogwheel Rigidity Foreign Quetiapine PS ORAL 300 MG PO Dyskinesia Health Risperidone SS ORAL 10 MG PO Dystonia Professional Efexor Xl C Movement Disorder Other Restlessness Date:11/14/03ISR Number: 4236627-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031101493 Age:37 YR Gender:Male I/FU:I Outcome PT Other Anaemia Serum Ferritin Decreased White Blood Cell Count 22-Feb-2006 08:20 AM Page: 1841 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Risperidone) PS ORAL SEE IMAGE Professional Biperiden Hydrochloride (Beiperiden Hydrochloride) C Diazepam (Diazepam) C Brotizolam (Brotizolam) C Nitrazepam (Nitrazepam) C Lorazepam (Lorazepam) C Date:11/14/03ISR Number: 4236651-7Report Type:Expedited (15-DaCompany Report #2003184369AU Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypotension Foreign Rogaine Hospitalization - Intentional Misuse Health (Minoxidil)Solution Initial or Prolonged Intentional Overdose Professional 5% PS ORAL 120 ML, Other Metabolic Acidosis Other TOTAL, ORAL Multiple Drug Overdose Sertraline Somnolence (Sertraline Tachycardia Hydrochloride) Capsule SS ORAL 20 50 MG TABLETS ONCE, ORAL "Citaloprm" SS ORAL 40 25 MG TABLETS,ORAL Sequinan (Risperidone) Tablet SS ORAL 20 1MG TABLETS, ORAL Date:11/17/03ISR Number: 4236972-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031101306 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal Systemic Lupus Health (Risperidone) PS ORAL 4 MG, IN 1 Erythematosus Professional DAY, ORAL Carbamazepin (Carbamazepine) C Date:11/17/03ISR Number: 4237051-6Report Type:Expedited (15-DaCompany Report #S03-GER-04403-01 Age:51 YR Gender:Female I/FU:F Outcome PT Other Drug Toxicity Nephritis Interstitial Normochromic Normocytic Anaemia Red Blood Cell Sedimentation Rate Increased 22-Feb-2006 08:20 AM Page: 1842 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Tubular Disorder Schizophrenia Sleep Disorder Report Source Product Role Manufacturer Route Dose Duration Foreign Cipramil (Citalopram Health Hydrobromide) PS ORAL 40 MG QD PO Professional Risperdal Other (Risperidone) SS ORAL 4 MG QD PO Eunerpan (Melperone Hydrochloride) SS ORAL 25 MG QD PO Seroquel (Quetiapine Fumarate) SS ORAL 750 MG QD PO Date:11/17/03ISR Number: 4237137-6Report Type:Expedited (15-DaCompany Report #2003111286 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Atarax (Hydroxyzine Initial or Prolonged Agitation Professional Hydrochloride) PS ORAL 100 MG (TID), Bladder Distension ORAL Confusional State Ferrous Sulfate Dementia (Ferrous Sulfate) SS ORAL ORAL Disorientation Madopar (Levodopa, Dyskinesia Benserazide Hallucination Hydrochloride) SS ORAL 500 MG Hypertonia (DAILY),ORAL Pyrexia Risperidone Somnolence (Risperidone) SS ORAL 1 MG Speech Disorder (DAILY),ORAL Date:11/17/03ISR Number: 4237187-XReport Type:Expedited (15-DaCompany Report #2003117012 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Foreign Zoloft (Sertraline) PS ORAL 1000 MG Initial or Prolonged Metabolic Acidosis Health (ONCE), ORAL Somnolence Professional Minoxidil Tachycardia (Minoxidil) SS ORAL 120 ML (ONCE), ORAL Citalopram (Citalopram) SS ORAL 1000 MG (ONCE), ORAL Risperidone (Risperidone) SS ORAL 20 MG (ONCE), ORAL Date:11/17/03ISR Number: 4237230-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031002035 Age:84 YR Gender:Female I/FU:F Outcome PT Death Acute Pulmonary Oedema Hospitalization - Bacteria Urine Identified Initial or Prolonged Bradycardia Cardiac Arrest Enterococcal Infection Fatigue Gastrointestinal Haemorrhage General Physical Health 22-Feb-2006 08:20 AM Page: 1843 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Deterioration Haemoglobin Decreased Klebsiella Infection Oxygen Saturation Report Source Product Role Manufacturer Route Dose Duration Decreased Health Risperdal Renal Failure Professional (Risperidone) White Blood Cell Count Tablets PS 0.5 MG, 1 IN Increased 1 DAY Norvasc (Amlodipine Besilate) C Bumex (Bumetanide) C Digoxin (Digoxin) C Imdur (Isosorbide Mononitrate) C Zoloft (Sertraline Hydrochloride) C Synthroid (Levothyroxine Sodium) C Lipitor (Atorvastatin) C Aspirin (Acetylsalicylic Acid) C Potassium Cl (Potassium Chloride) C Coreg (Carvedilol) C Magnesium Gluconate (Magnesium Gluconate) C Multivitamin (Multivitamins) C Ocuvite With Lutein (Ocuvite) C Ferrous Sulfate (Ferrous Sulfate) C Vitamin E (Tocopherol) C Extra Strength Tylenol (Paracetamol) C Human Insulin (Insulin Human) C Nitroglycerin (Glyceryl Trinitrate) C Loperamide Hydrochloride (Loperamide Hydrochloride) C Albuterol Sulfate (Salbutamol Sulfate) C Date:11/19/03ISR Number: 4238591-6Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20031103186 Age:59 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myoclonus Foreign Risperdal Consta Initial or Prolonged Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, INTRAMUSCULAR 22-Feb-2006 08:20 AM Page: 1844 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/03ISR Number: 4238740-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031102063 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Risperdal Initial or Prolonged Dialysis Health (Risperidone) Palpitations Professional Unspecified PS ORAL 12 MG, IN 1 Renal Failure Acute DAY ORAL Rhabdomyolysis Etilefrine Hydrochloride (Etilefrine Hydrochloride) C Carbamazepine (Carbamazepine) C Nemonapride (Nemonapride) C Cloxazolam (Cloxazolam) C Sennoside (All Other Therapeutic Products) C Date:11/19/03ISR Number: 4238741-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030903443 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Risperdal Initial or Prolonged Status Epilepticus Health (Risperidone) Professional Unspecified PS ORAL SEE IMAGE Date:11/19/03ISR Number: 4239000-3Report Type:Expedited (15-DaCompany Report #2003-03842 Age:35 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Clonazepam (Watson Health Laboratories)(Clonaz Professional epam) Tablet PS Valproic Acid (Valproic Acid) Unknown SS Risperidone (Risperidone) SS Date:11/19/03ISR Number: 4239404-9Report Type:Expedited (15-DaCompany Report #US_JNJFOC-20031102539 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiotoxicity Health Risperdal Hospitalization - Drug Interaction Professional (Risperidone) Initial or Prolonged Tablets PS ORAL 0.25 MG, 2 IN 1 DAY, ORAL Date:11/19/03ISR Number: 4239405-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030703153 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Other Generalised Oedema Health Professional 22-Feb-2006 08:20 AM Page: 1845 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Risperdal (Risperidone) Unspecified PS ORAL ORAL Geodon (Ziprasidone Hydrochoride) SS ORAL ORAL Celebrex (Celecoxib) C Hctz (Hydrochlorotiazide) C Effexor (Venlafaxine Hydrochloride) C Serzone (Nefazodone Hydrochloride) C Date:11/19/03ISR Number: 4239406-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031001817 Age:87 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL 1 MG, 1 IN 1 DAY, ORAL Date:11/19/03ISR Number: 4239407-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031102715 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Study Risperidone Weight Increased Health (Risperidone) Professional Unspecified PS Olanzapine (Olanzapine) SS Quetiapine (Quetiapine) SS Ziprasidone (Ziprasidone) SS Perphenazine (Perphenazine) SS Date:11/20/03ISR Number: 4238160-8Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0431625A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Wellbutrin PS Glaxosmithkline ORAL Risperdal SS UNKNOWN Date:11/20/03ISR Number: 4239409-8Report Type:Direct Company Report #CTU 206544 Age:93 YR Gender:Female I/FU:I Outcome Death Life-Threatening Hospitalization - Initial or Prolonged Disability 22-Feb-2006 08:20 AM Page: 1846 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Aphasia Risperdal 1 Mg 0.5, Dyspnoea 0.25 PS 1 MG 0.5 MG Off Label Use Oral Intake Reduced Pain Renal Failure Septic Shock Date:11/20/03ISR Number: 4239466-9Report Type:Expedited (15-DaCompany Report #NSADSS2002044455 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Urea Increased Consumer Risperdal Constipation Health (Risperidone) Intestinal Perforation Professional Tablets PS 0.5MG QAM & Lung Infiltration 1MG PM White Blood Cell Count Celexa (Citalopram Decreased Hydrobromide) C Zestoretic (Prinzide) C Ciprofloxacin C Zosyn (Pip/Tazo) C Femhart (Anovlar) C Aspirin (Acetylsalicylic Acid) C Colace (Docusate Sodium) C Milk Of Magnesia (Magnesium Hydroxide) C Date:11/20/03ISR Number: 4239467-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031103373 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS Date:11/20/03ISR Number: 4239612-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030901766 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Neoplasm Foreign Risperdal Initial or Prolonged Hyperprolinaemia Health (Risperidone) Other Professional Unspecified PS ORAL 1 MG, ORAL Lorazepam (Lorazepam) C Quetiapine (Quetiapine) C 22-Feb-2006 08:20 AM Page: 1847 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/20/03ISR Number: 4239616-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030801564 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal Health (Risperidone) Professional Unspeciified PS ORAL 2 MG, 1 IN 1 DAY, ORAL Lithium (Lithium) C Date:11/20/03ISR Number: 4239618-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031102954 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperdal Hypoxic Encephalopathy Health (Risperidone) Professional Unspecified PS ORAL 4 MG, IN 1 DAY, ORAL Date:11/20/03ISR Number: 4239657-7Report Type:Expedited (15-DaCompany Report #2003116898 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Sertraline Hyperprolactinaemia Health (Sertraline) PS 100 MG Secretion Discharge Professional (DAILY), ORAL Other Risperidone (Risperidone) SS ORAL 6 MG (DAILY), ORAL Oxcarbazepine (Oxcarbazepine) C Date:11/20/03ISR Number: 4240077-XReport Type:Periodic Company Report #PHEH2003US06923 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Consumer Zelnorm (Tegaserod) Dry Mouth Tablet PS ORAL 6 MG BID ORAL Rash Trileptal (Oxcarbazepine) Tablet SS ORAL ORAL Anafranil (Clomipramine Hydrochloride) Unknown SS UNKNOWN UNK Risperdal (Risperidone) SS UNKNOWN UNK Docusate (Docusate) C Dicyclomine Hydrochloride (Dicycloverine Hydrochloride) C Alprazolam (Alprazolam) C Buspirone (Buspirone) C 22-Feb-2006 08:20 AM Page: 1848 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241756-0Report Type:Expedited (15-DaCompany Report #2003117724 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Foreign Zeldox (Capsules) Initial or Prolonged Dizziness Health (Ziprasidone) PS ORAL 40 MG (BID), Disability Drug Ineffective Professional ORAL Drug Interaction Risperidone Feeling Abnormal (Risperidone) SS ORAL 0.75 MG Headache (DAILY), ORAL Syncope Mirtazapine Treatment Noncompliance (Mirtazapine) C Weight Increased Date:11/24/03ISR Number: 4241760-2Report Type:Expedited (15-DaCompany Report #2003185300TR Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Foreign Erythocin(Erythromyc Initial or Prolonged Thromboplastin Time Other in)Tablet PS ORAL ORAL Prolonged Sequinan(Risperidone Agitation )Tablet SS ORAL ORAL Alanine Aminotransferase Dramamine(Dimenhydri Increased nate)Tablet SS ORAL ORAL Blood Creatine Biperiden(Biperiden) SS ORAL ORAL Phosphokinase Increased Acetaminophen(Parace Blood Pressure Diastolic tamol) SS ORAL ORAL Decreased Venlafaxine(Venlafax Drug Interaction ine) SS ORAL ORAL Drug Toxicity Alverine Citrate Erythema (Alverine Citrate) SS ORAL ORAL Heart Rate Increased Simethicone Loss Of Consciousness (Dimeticone, Multiple Drug Overdose Activated) SS ORAL ORAL Pyrexia Respiratory Rate Increased Stupor Suicide Attempt Date:11/24/03ISR Number: 4241864-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031102974 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Unspecified SS Impiramine (Imipramine) C 22-Feb-2006 08:20 AM Page: 1849 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241865-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031101054 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Increased Foreign Risperdal Liver Function Test Health (Risperidone) Abnormal Professional Unspecified PS Red Blood Cell Count Increased Date:11/24/03ISR Number: 4241869-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031102370 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lower Respiratory Tract Foreign Risperdal Initial or Prolonged Infection Health (Risperidone) Renal Failure Acute Professional Unspecified PS Date:11/24/03ISR Number: 4241871-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031102700 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Foreign Risperdal General Physical Health Health (Risperidone) Deterioration Professional Tablets PS ORAL ORAL Incontinence Date:11/24/03ISR Number: 4241879-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031102704 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Increased Foreign Risperdal General Physical Health Health (Risperidone) Deterioration Professional Tablets PS ORAL ORAL Incontinence Date:11/24/03ISR Number: 4241880-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031102968 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Risperdal Initial or Prolonged Blood Creatinine Health (Risperidone) Increased Professional Unspecified PS ORAL 0.5 MG, IN 1 Blood Glucose Increased DAY, ORAL; 3 Blood Pressure Decreased MG, IN 1 DAY, Blood Urea Increased ORAL; 1 MG, Cardiac Murmur ORAL Condition Aggravated Preterax (Bi Depression Predonium) Tablets SS ORAL 1 DOSE(S), IN Drug Interaction 1 DAY, ORAL Fall Di-Antalvic (Aporex) Hallucinations, Mixed Capsules SS ORAL 6 DOSE(S), IN Muscular Weakness 1 DAY, ORAL Myocardial Ischaemia Avlocardyl Renal Cyst (Propanolol) C 22-Feb-2006 08:20 AM Page: 1850 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/03ISR Number: 4241881-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031104079 Age:60 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 7 MG, IN 1 DAY, ORAL Timiperone (Timiperone) Unknown C Date:11/25/03ISR Number: 4240744-8Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0383144A Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Bupropion PS Glaxosmithkline ORAL Supraventricular Warfarin SS Glaxosmithkline UNKNOWN Completed Suicide Carbamazepine SS UNKNOWN Depressed Level Of Risperidone SS Consciousness Sertraline SS Intentional Overdose Marijuana C International Normalised Cocaine C Ratio Increased Multiple Drug Overdose Tachycardia Date:11/25/03ISR Number: 4240745-XReport Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0383149A Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Bupropion PS Glaxosmithkline ORAL Blood Sodium Increased Risperidone SS UNKNOWN Cardiac Arrest Diphenhydramine SS UNKNOWN Disseminated Intravascular Coagulation Feeling Abnormal Haematocrit Decreased Medication Error Mental Status Changes Pyrexia Staring Tremor Date:11/25/03ISR Number: 4242214-XReport Type:Expedited (15-DaCompany Report #2003-04108 Age:24 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Alprazolam (Watson Health Laboratories)(Alpraz Professional olam) Tablet PS Watson Laboratories Maprotiline (Watson Laboratories)(Maprot iline Hydrochloride) Tablet SS Watson Laboratories Risperidone(Risperid one) SS 22-Feb-2006 08:20 AM Page: 1851 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/25/03ISR Number: 4242297-7Report Type:Expedited (15-DaCompany Report #B0314536A Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Literature Lithium Salt Initial or Prolonged Increased Health (Formulation Blood Pressure Increased Professional Unknown) (Lithium Body Temperature Salt) PS 450 MG/ TWICE Increased PER DAY Cerebral Atrophy Risperidone Confusional State (Formulation Delirium Unknown) Delusion (Risperidone) SS Hallucination, Auditory Olanzapine C Heart Rate Increased Semisodium Valproate C Insomnia Liver Function Test Abnormal Muscle Rigidity Neuroleptic Malignant Syndrome Speech Disorder Tremor White Blood Cell Count Increased Date:11/25/03ISR Number: 4242454-XReport Type:Expedited (15-DaCompany Report #03P-163-0241006-00 Age:20 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Valproic Acid Health (Depakene) PS ORAL ORAL Professional Quetiapine SS ORAL ORAL Risperidone SS ORAL ORAL Date:11/25/03ISR Number: 4243038-XReport Type:Periodic Company Report #2003037868 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Lipitor Phosphokinase Increased Professional (Atorvastatin) PS 10 MG Rhabdomyolysis Company Risperidone Representative (Risperidone) SS Date:11/26/03ISR Number: 4244039-8Report Type:Expedited (15-DaCompany Report #AR-JNJFOC-20031103594 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Foreign Risperdal Initial or Prolonged Pregnancy Health (Risperidone PS ORAL 2 MG, IN 1 Dystonia Professional DAY, ORAL Electroencephalogram Rivotril Abnormal (Clonazepam) C Extrapyramidal Disorder 22-Feb-2006 08:20 AM Page: 1852 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/03ISR Number: 4244041-6Report Type:Expedited (15-DaCompany Report #APCDSS2003000714 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Maternal Drugs Affecting Foreign Risperdal Foetus Health (Risperidone) Respiratory Disorder Professional Unspecified PS TRANSPLACENTAL 6 MG, IN Neonatal 1DAY, Respiratory Rate INTRAUTERINE Decreased Haldol (Haloperidol) Unspecified SS TRANSPLACENTAL 1 DOSE(S), 1 IN 1DAY, INTRAUTERINE Biperiden (Biperiden) Ampoules C Date:11/26/03ISR Number: 4244128-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031103573 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Macular Degeneration Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 1 MG, 1 IN 1 DAY, ORAL Date:11/26/03ISR Number: 4244271-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031002590 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aplastic Anaemia Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, 1 IN 24 HOUR, ORAL Date:11/26/03ISR Number: 4244278-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031104044 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Iron Decreased Health Risperdal Professional (Risperidone) PS Date:11/26/03ISR Number: 4244281-6Report Type:Expedited (15-DaCompany Report #2003PK01801 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bacterial Infection Foreign Seroquel PS ORAL 750 MG DAILY Initial or Prolonged Drug Toxicity Other PO Required Nephritis Interstitial Risperidon SS ORAL 4 MG DAILY PO Intervention to Nephropathy Melperon SS ORAL 25 MG DAILY Prevent Permanent Normochromic Normocytic PO Impairment/Damage Anaemia Citalopram SS ORAL 40 MG DAILY Red Blood Cell PO Sedimentation Rate Increased Renal Tubular Disorder 22-Feb-2006 08:20 AM Page: 1853 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/03ISR Number: 4244284-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031104355 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hip Fracture Health Risperdal Thrombosis Professional (Risperidone) Tablets PS ORAL 0.5 MG, IN 1 DAY, ORAL Date:11/26/03ISR Number: 4244286-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031104484 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, 2 IN 1 DAY, ORAL Date:11/28/03ISR Number: 4244458-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031103857 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Foreign Risperdal Dysphagia Health (Risperidone) Dyspnoea Professional Unspecified PS ORAL 0.5 MG, ORAL Dystonia Face Oedema Muscle Rigidity Musculoskeletal Stiffness Pallor Speech Disorder Tremor Date:11/28/03ISR Number: 4244459-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031103371 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperidone Face Oedema Health (Risperidone) Oedema Professional Unspecified PS ORAL 2 MG, 1 IN 1 Oedema Peripheral DAY, ORAL Rivotril (Clonazepam) C Date:11/28/03ISR Number: 4244460-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031005437 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death General Physical Health Foreign Risperdal Deterioration Health (Risperidone) Hepatocellular Damage Professional Unspecified PS ORAL 0.5 MG, 1 IN Somnolence 1 DAY, ORAL Depamide (Valpromide) C Alprazolam C Stilnox (Zolpidem) C Nitriderm (Glyceryl Trinitrate) C 22-Feb-2006 08:20 AM Page: 1854 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hept-A-Myl (Hepatminol Hydrochloride) C Depakine (Valproate Sodium) C Date:11/28/03ISR Number: 4244461-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030801869 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Risperdal Initial or Prolonged Cardiogenic Shock Health (Risperidone) Congestive Cardiomyopathy Professional Unspecified PS ORAL 1 MG, IN 1 Liver Disorder DAY, ORAL Pleural Effusion Truxal Pulmonary Oedema (Clorprothixene Rhabdomyolysis Hydrochloride) C Ventricular Dysfunction Carbamazepine C Zuclopenthixol C Allopurinol C Date:11/28/03ISR Number: 4244462-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031101306 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal Systemic Lupus Health (Risperidone) PS ORAL 4 MG, IN 1 Erythematosus Professional DAY, ORAL Carbamazepin (Carbamazepine) C Date:11/28/03ISR Number: 4244465-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031103858 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Arthralgia Foreign Risperdal Consta Bone Disorder Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, INTRA-MUSCULA R Diazepam C Lorazepam C Date:11/28/03ISR Number: 4244466-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031003546 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Ejaculation Delayed Foreign Risperdal Consta Erectile Dysfunction Health (Risperidone) Semen Volume Decreased Professional Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Lanzoprazole C Procylidine C 22-Feb-2006 08:20 AM Page: 1855 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/03ISR Number: 4244472-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031104433 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Femur Fracture Foreign Risperdal Forearm Fracture Health (Risperidone) PS ORAL 4 MG, IN 1 Sepsis Professional DAY, ORAL Other Haloperidol Decanoate Injection SS INTRAMUSCULAR 100 MG, INTRA-MUSCULA R Haloperidol (Haloperidol) C Flunitrazepam (Flunitrazepam) C Date:11/28/03ISR Number: 4244473-6Report Type:Expedited (15-DaCompany Report #BR-JNJFOC-20031104708 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Risperdal Initial or Prolonged Coma Health (Risperidone) PS ORAL 2 MG, 1 IN 1 Infection Professional DAY, ORAL Date:11/28/03ISR Number: 4244474-8Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20031004169 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Foreign Risperdal Health (Risperidone) PS 0.5 MG, 1 IN Professional 1 DAY Date:11/28/03ISR Number: 4244475-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031102953 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperdal Hospitalization - Drug Interaction Health (Risperidone) PS ORAL 4 MG, IN 1 Initial or Prolonged Hypoxic Encephalopathy Professional DAY, ORAL Vegetamin-A (Vegetamin A) SS ORAL 1 DOSE(S), 1 IN 1 DAY, ORAL Flunitrazepam (Flunitrazepam) C Date:11/28/03ISR Number: 4245410-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030804621 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Decreased Consumer Risperdal Hospitalization - Coma (Risperidone) Initial or Prolonged Drug Toxicity Tablets PS ORAL 3 MG, 1 IN 1 Myocardial Infarction DAY, ORAL Pneumonia Lithium (Lithium) Tablets SS 600MG IN AM/300MG IN PM 22-Feb-2006 08:20 AM Page: 1856 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote (Valproate Semisodium) C Lanoxin (Digoxin) C Aspirin (Acetylsalicylic Acid) C Insulin C Monopril (Fosinopril Sodium) C Date:11/28/03ISR Number: 4245443-4Report Type:Expedited (15-DaCompany Report #NSADSS2003021343 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Reminyl Initial or Prolonged Balance Disorder Health (Galantamine) Blood Pressure Systolic Professional Tablets PS ORAL 2 MG, 2 IN 24 Increased HOUR , ORAL: Clavicle Fracture 4 MG, 2 IN 1 Confusional State DAY, ORAL: 8 Delirium MG, 2 IN 1 Delusional Disorder, Risperdal(Risperdone Unspecified Type ) SS ORAL 0.25 MG, 1IN Diarrhoea I DAY, ORAL Fall Triamcinolone C Hip Fracture Evista (Raloxifene Muscle Spasms Hydrochloride) C Overdose Celexa (Citalopram Pain In Jaw Hydrobromide) C Parkinsonism Calcium C Post Procedural Vitamin D Complication (Ergocalciferol) C Salivary Gland Calculus Aspirin Tremor (Acetylsalicylic Acid) C Pletal (Cilostazol) C Lexapro (All Other Therapeutic Products) C Trazodone C Hydroxyzine C Centrum Silver C Alphagan (Brimonidine Tartrate) C Acular (Ketorolac Tromethamine) C Aleve (Naproxen Sodium) C Date:11/28/03ISR Number: 4265844-8Report Type:Periodic Company Report #MPS1-10105 Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Emotional Disorder Health Aldurazyme PS INTRAVENOUS 0.58 MG/KG Professional QWK IV Risperdal SS Risperdal C 22-Feb-2006 08:20 AM Page: 1857 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/01/03ISR Number: 4243462-5Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0042495A Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Seroxat PS Glaxosmithkline ORAL 20MG Variable Initial or Prolonged Drug Interaction dose 28 DAY Galactorrhoea Risperdal SS ORAL 3MG Variable Hyperprolactinaemia dose Valette C ORAL 1TAB Per day Date:12/01/03ISR Number: 4243652-1Report Type:Expedited (15-DaCompany Report #PHBS2003IT13085 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Oxcarbazepine PS Novartis Sector: Initial or Prolonged Coma Pharma UNKNOWN 8700 mg/d Intentional Overdose Risperidone SS UNKNOWN 60 mg/d Oculogyration Risperidone SS UNKNOWN 6 mg/d Atenolol SS UNKNOWN 1400 mg/d Date:12/02/03ISR Number: 4244663-2Report Type:Direct Company Report #CTU 207178 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Paxil 30 Mg Initial or Prolonged Akathisia Glaxosmithkline PS Glaxosmithkline ORAL 60 MG QD ORAL Required Asthenia Risperdal 0.5 Mg Intervention to Dizziness Jannsen SS Jannsen ORAL 0.5 MG/1 MG Prevent Permanent Fall QAM/QHS ORAL Impairment/Damage Gait Disturbance Amantadine C Lacunar Infarction Bupropion-Wellbutrin Nuclear Magnetic Sr- C Resonance Imaging Brain Lorazepam C Abnormal Paroxetine C Tremor Ranitidine C Risperidone C Vit E C Vit C C Ecasa C Mvi C Ibuprofen C Loratadine C Meclizine Hcl C Date:12/02/03ISR Number: 4245620-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031104433 Age:88 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sepsis Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 4 MG, 1 IN 1 DAY, ORAL Haloperidol Decanoate (Haloperidol Decanoate) Injection SS INTRAMUSCULAR 100 MG, IN 1 4 WEEK, INTRA MUSCULAR Flunitrazepam 22-Feb-2006 08:20 AM Page: 1858 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Flunitrazepam) C Date:12/02/03ISR Number: 4245625-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031105015 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Abnormal Foreign Risperdal Initial or Prolonged Convulsion Health (Risperidone) Headache Professional Solution PS ORAL 0.3 G, 1 IN 1 Hyperhidrosis DAY, ORAL Hypothermia Medication Error Nausea Overdose Respiratory Depression Somnolence Date:12/02/03ISR Number: 4245626-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031105516 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Feeling Abnormal Foreign Risperdal Consta Life-Threatening Intestinal Infarction Health (Risperidone) Hospitalization - Treatment Noncompliance Professional Microspheres PS INTRAMUSCULAR INTRA-MUSCULA Initial or Prolonged R Lithium (Lithium) Unknown SS Chlorpromazine (Chlorpromazine) C Date:12/02/03ISR Number: 4246180-2Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20031105410 Age:1 MON Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Foreign Risperdal Complications Of Maternal Health (Risperidone) Exposure To Therapeutic Professional Tablets PS INTRA-UTERINE 4 MG, IN 1 Drugs DAY, Drug Exposure During INTRAUTERINE Pregnancy Zoloft (Sertraline Drug Withdrawal Syndrome Hydrochloride) Neonatal Unknown C Maternal Drugs Affecting Aurorix Foetus (Moclobemide) Neonatal Disorder Unknown C Marcain (Bupivacaine Hydrochloride) Unknown C Fentanyl (Fentanyl) Unspecified C Date:12/02/03ISR Number: 4246296-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031102063 Age:43 YR Gender:Male I/FU:F Outcome PT Hospitalization - Abulia Initial or Prolonged Anxiety Asthenia 22-Feb-2006 08:20 AM Page: 1859 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Autism Catatonia Delusion Report Source Product Role Manufacturer Route Dose Duration Dialysis Foreign Risperdal Hallucination, Auditory Health (Risperidone) Hyperkalaemia Professional Unspecified PS ORAL 8 MG, 1 IN 1 Increased Appetite Other DAY, ORAL Intentional Self-Injury Nemonapride Palpitations (Nemonapride) SS ORAL 40 MG, IN 1 Renal Failure Acute DAY, ORAL Rhabdomyolysis Zotepine (Zotepine) SS ORAL 200 MG, IN 1 Weight Increased DAY, ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL 400 MG, IN 1 DAY, ORAL Trihexphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Etilefrine Hydrochloride (Etilefrine Hydrochloride) C Carbamazepine (Carbamazepine) C Cloxazolam (Cloxazolam) C Sennoside (All Other Therapeutic Products) C Lorazepam (Lorazepam) C Date:12/02/03ISR Number: 4246299-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030906448 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abortion Induced Foreign Risperdal Congenital Anomaly Complications Of Maternal Health (Risperidone) Exposure To Therapeutic Professional Unspecified PS Drugs Maternal Drugs Affecting Foetus Multiple Congenital Abnormalities Pregnancy Date:12/02/03ISR Number: 4246431-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031104673 Age: Gender:Male I/FU:I Outcome PT Other Alopecia Diplopia Drooling Faecal Incontinence Memory Impairment Overdose Posture Abnormal 22-Feb-2006 08:20 AM Page: 1860 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Tardive Dyskinesia Vision Blurred Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal (Risperidone) Tablets PS ORAL ORAL Haldol (Haloperidol) Unspecified SS Cogentin (Benzatropine Mesilate) SS Date:12/03/03ISR Number: 4246303-5Report Type:Expedited (15-DaCompany Report #FI-JNJFOC-20031104491 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anorexia Foreign Risperdal Dependent Personality Health (Risperidone) Disorder Professional Tablets PS ORAL 2 MG, IN 1 Dysarthria Other DAY, ORAL Rash Atenol (Tablets) Salivary Hypersecretion Atenolol C Weight Decreased Uretren (Tablet) Triamterene C Thyroxin (Tablets) Levothyroxine Sodium C Marevan Forte (Warfarin Sodium) Tablets C Daktarin (Miconazole Nitrate) Gel C Date:12/03/03ISR Number: 4246668-4Report Type:Expedited (15-DaCompany Report #2003119691 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Allergic Foreign Neurontin Initial or Prolonged Rash Health (Gabapentin) PS ORAL 1200 MG, ORAL Professional Risperidone (Risperidone) SS 5 MG Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) SS 100 MG Paracetamol (Paracetamol) SS 500 MG Lithium Acetate (Lithium Acetate) C Lactulose (Lactlose) C Date:12/04/03ISR Number: 4246934-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030800612 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Risperdal Circulatory Collapse Professional (Risperidone) Myocardial Fibrosis Unspecified PS 2 MG, 2 IN 1 Ventricular Fibrillation DAY 22-Feb-2006 08:20 AM Page: 1861 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote (Valproate Semisodium) SS 250 MG, 2 IN 1 DAY Zyprexa (Olanzapine) C Date:12/04/03ISR Number: 4246965-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031105157 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:12/04/03ISR Number: 4246968-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030800611 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 3 MG, 1 IN 1 DAY, ORAL Date:12/04/03ISR Number: 4246972-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20031105229 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Arrest Health Risperdal Initial or Prolonged Tongue Paralysis Professional (Risperidone) Company Tablets PS ORAL 1 MG, 1 IN 1 Representative DAY, ORAL Date:12/04/03ISR Number: 4246995-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031200016 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS Date:12/04/03ISR Number: 4247346-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031102954 Age:25 YR Gender:Female I/FU:F Outcome PT Death Alanine Aminotransferase Increased Blood Amylase Increased Blood Chloride Decreased Blood Creatine Phosphokinase Increased Blood Glucose Increased Blood Potassium Increased Blood Sodium Decreased Brain Stem Auditory Evoked Response Abnormal Cardio-Respiratory Arrest Cold Sweat Hypoxic Encephalopathy Mydriasis Pupillary Reflex Impaired 22-Feb-2006 08:20 AM Page: 1862 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Red Blood Cell Count Increased Snoring Report Source Product Role Manufacturer Route Dose Duration White Blood Cell Count Foreign Risperdal Decreased Health (Risperidone) PS ORAL 2 MG, IN 1 Professional DAY, ORAL Ofloxacin (Oxloxacin) C Suplatast Tosilate (Suplatast Tosilate) C Ursodesoxycholic Acid (Ursodeoxycholic Acid) C Theophylline (Theophylline) C Date:12/04/03ISR Number: 4247368-7Report Type:Direct Company Report #CTU 207500 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Leukopenia Risperdal PS ORAL 5 MG HS QD PO Intervention to Lymphocytosis Prevent Permanent Neutropenia Impairment/Damage Date:12/04/03ISR Number: 4247494-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031101493 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal Serum Ferritin Increased Health (Risperidone) White Blood Cell Count Professional Unspecified PS ORAL SEE IMAGE Decreased Biperiden Hydrochloride (Biperiden Hydrochloride) C Diazepam (Diazepam) C Brotizalam (Brotizolam) C Nitrazepam (Nitrazepam) C Lorazepam (Lorazepam) C Date:12/05/03ISR Number: 4246467-3Report Type:Expedited (15-DaCompany Report #WAES 0312USA00322 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Potassium Increased Cozaar PS Merck & Co., Inc ORAL Initial or Prolonged Depressed Level Of Doxazosin Mesylate SS ORAL Other Consciousness Estazolam SS ORAL Generalised Oedema Nifedipine SS ORAL Pleural Effusion Risperidone SS ORAL Pulmonary Oedema Spironolactone SS ORAL Shock Metoprolol Tartrate SS ORAL Suicide Attempt Etizolam C ORAL Rilmazafone 22-Feb-2006 08:20 AM Page: 1863 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride C ORAL Date:12/05/03ISR Number: 4247428-0Report Type:Direct Company Report #CTU 207560 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatic Pseudocyst Risperidone PS ORAL 0.5 MG PO BID Initial or Prolonged Pancreatitis Date:12/05/03ISR Number: 4247442-5Report Type:Direct Company Report #CTU 207545 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Risperdal 6 Mg/Day Inadequate Control Johnson And Johnson PS Johnson And Johnson ORAL 6 MG ORAL Malaise Weight Decreased Weight Increased Date:12/05/03ISR Number: 4248329-4Report Type:Expedited (15-DaCompany Report #DEWYE425726NOV03 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Trevilor Initial or Prolonged Increased Study (Venlafaxine Drug Interaction Health Hydrochloride) PS ORAL SEE IMAGE FOR Gamma-Glutamyltransferase Professional DOSE & Increased Other ADDITIONAL THERAPY DATES 12 DAY Risperdal (Risperidone) SS ORAL 2 MG ORAL Tavor (Lorazepam) C .... C ... C ..... C .... C .... C Quilonum - Slow Release (Lithium Carbonate) C .... C .......... C ........ C Chloraldurat (Chloral Hydrate) C Beloc Zok (Metoprolol Succinate) C ............. C Remergil (Mirtazapine) C ............ C 22-Feb-2006 08:20 AM Page: 1864 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/03ISR Number: 4248744-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031105447 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extradural Haematoma Foreign Risperdal Initial or Prolonged Hallucination Health (Risperidone) PS ORAL 8 MG, IN 1 Medication Error Professional DAY, ORAL Psychotic Disorder Zyprexa (Olanzapine) C Radius Fracture Date:12/08/03ISR Number: 4248760-7Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20031000421 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypomania Foreign Risperdal Other Health (Risperidone) Professional Unspecified PS 1 MG, 1 IN 1 DAY, Aricept (Donepezil Hydrochloride) C Bromazepam (Bromazepam) C Dipyridamole (Dipyridamole) C Nitroderm (Glyceryl Trinitrate) C Tenormin (Atenolol) C Lipitor (Atorvastatin) C Stilnoct (Zolpidem Tartrate) C Date:12/08/03ISR Number: 4248766-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031105385 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Foreign Risperdal Hospitalization - Extrapyramidal Disorder Health (Risperidone) Initial or Prolonged Septic Shock Professional Tablets PS ORAL 0.5 MG, 2 IN Company 1 DAY, ORAL Representative Date:12/08/03ISR Number: 4248768-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031006567 Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Bradyphrenia Foreign Risperdal Bruxism Consumer (Risperidone) Depression Health Tablets PS ORAL 2 MG, 2 IN 1 Dyskinesia Professional DAY, ORAL Extrapyramidal Disorder Warfarin (Warfarin) C Frusemide (Furosemide) C Losartan (Losartan) C Temazepam (Temazepam) C Thiamine (Thiamine) C Vitamin B Comp (B-Komplex "Leciva") C 22-Feb-2006 08:20 AM Page: 1865 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/03ISR Number: 4248856-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031002641 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cellulitis Foreign Risperdal Consta Initial or Prolonged Neuroleptic Malignant Health (Risperidone) Other Syndrome Professional Microspheres PS INTRAMUSCULAR INTRA-MUSCULA R Lorazepam (Lorazepam) C Zopiclone (Zopiclone) C Bisoprolol (Bisoprolol) C Metformin (Metformin) C Pravastatine (Pravastatin) C Pioglitazone (Pioglitazone) C Date:12/08/03ISR Number: 4249086-8Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20030804759 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis B Foreign Risperdal Consta Health (Risperidone) Professional Microspheres PS INJECTION Risperidone (Risperidone) Solution SS ORAL 3 MG , 1 IN 1 DAY, ORAL Panadeine (Panadeine Co) C Quetiapine C Lorazepam C Clonazepam/Haloperid ol (All Other Therapeutic Products) C Clonazepam C Date:12/08/03ISR Number: 4249174-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031102953 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Death Foreign Risperdal Hospitalization - Cardio-Respiratory Arrest Health (Risperidone) Initial or Prolonged Conversion Disorder Professional Tablets PS ORAL 2 MG, 2 IN 1 Dizziness DAY, ORAL Drug Interaction Vegetamin-A Fall (Vegetamin A) Heart Rate Increased Tablets SS ORAL 1 DOSE (1), 1 Hypoxic Encephalopathy IN 1 DAY, Incontinence ORAL Pupillary Reflex Impaired Flunitrazepam Syncope (Flunitrazepam) C Ventricular Fibrillation 22-Feb-2006 08:20 AM Page: 1866 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/03ISR Number: 4249181-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030805578 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Murmur Foreign Risperdal Disturbance In Attention (Risperidone) Dyspnoea Unspecified PS ORAL ORAL Fatigue Risperdal Consta Hypotrichosis (Risperidone) Memory Impairment Microspheres SS INTRAMUSCULAR 50 MG, 1 IN 2 Nausea WEEK, Pain In Extremity INTRA-MUSCULA Swelling Face R Thrombosis Vision Blurred Vomiting Weight Increased Date:12/08/03ISR Number: 4249345-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-200030705724 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Glossodynia Health Concerta Local Swelling Professional (Methylphenidate Oedema Peripheral Hydrochloride) Platelet Count Decreased Sustained Release Pyrexia Tablets PS ORAL 54 MG, 1 IN 1 Rash Erythematous DAY, ORAL Swollen Tongue Risperdal (Risperidone) Unspecified SS Keflex (Cefalexin Monohydrate) C Prozac (Fluoxetine Hydrochloride) C Date:12/09/03ISR Number: 4249842-6Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20030901644 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Colon Cancer Foreign Risperdal Other Hepatic Neoplasm Health (Risperidone) Malignant Professional Unspecified PS 4 MG Leukaemia Lithium (Lithium) C Clonazepam (Clonazepam) C Benztropine (Benzatropine Mesilate) C Date:12/09/03ISR Number: 4250126-0Report Type:Expedited (15-DaCompany Report #AR-JNJFOC-20030900906 Age:101 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Risperdal Insomnia Consumer (Risperidone) PS ORAL SEE IMAGE Muscle Rigidity Reminyl Psychomotor Hyperactivity (Galantamine) C Lorazepam 22-Feb-2006 08:20 AM Page: 1867 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Lorazepam) C Date:12/09/03ISR Number: 4250134-XReport Type:Expedited (15-DaCompany Report #AU-JNJFOC-20031104431 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Confusional State Health (Risperidone) PS Fall Professional Head Injury Subdural Haematoma Upper Limb Fracture Date:12/10/03ISR Number: 4250786-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20030904254 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Eruption Foreign Risperidone Initial or Prolonged Insomnia Health (Risperidone) Oedema Professional Unspecified PS ORAL 2 MG, IN 1 Sluggishness DAY, ORAL Swelling Face Quetiapine (Quetiapine) Unknown SS Date:12/11/03ISR Number: 4250997-8Report Type:Expedited (15-DaCompany Report #NSADSS2003006745 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Consumer Risperdal Pulmonary Disease Health (Risperidone) Dementia Professional Tablets PS ORAL 1 MG, ORAL Date:12/11/03ISR Number: 4251005-5Report Type:Expedited (15-DaCompany Report #NSADSS2003021376 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL 1 MG, 2 IN 1 Professional DAY, ORAL Novolin (Insulin Human Injection, Isophane) C Vicodin (Vicodin) C Catopril (Captopril) C Glyburide (Glibenclamide) C Fosamax (Alendronate Sodium) C Proscar (Finasteride) C Valerian Root (Valerian Root) C 22-Feb-2006 08:20 AM Page: 1868 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/03ISR Number: 4251008-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031005057 Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS Date:12/11/03ISR Number: 4251010-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031200594 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Risperdal Hip Fracture Professional (Risperidone) Mental Impairment (Tablet) PS ORAL ORAL Orthostatic Hypotension Pneumonia Transient Ischaemic Attack Date:12/11/03ISR Number: 4251011-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031200827 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cystitis Consumer Risperdal Initial or Prolonged Diarrhoea (Risperidone) Fall (Tablet) PS ORAL IN 1 DAY, Hallucination, Auditory ORAL Hypotension Xanax (Alprazolam) C Loss Of Consciousness Zoloft (Setraline Hydrochloride) C Vasotech (Enalapril Maleate) C Excelon (Rivastigmine Tartrate) C Date:12/11/03ISR Number: 4251012-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031200838 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Consumer Risperdal Hospitalization - Condition Aggravated (Risperidone) Initial or Prolonged Fall Unspecified PS ORAL ORAL Hip Fracture Date:12/11/03ISR Number: 4251014-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031200921 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS 22-Feb-2006 08:20 AM Page: 1869 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/11/03ISR Number: 4251016-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20031201049 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Consumer Risperdal (Risperidone) Tablets PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Aricept (Donepezil Hydrochloride) C Date:12/11/03ISR Number: 4251017-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031201384 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 1.5 MG, ORAL Date:12/11/03ISR Number: 4251124-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031201328 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal Initial or Prolonged Hypotension Health (Risperidone) Multiple Drug Overdose Professional Unspecified PS ORAL 12 MG, IN 1 Suicide Attempt DAY, ORAL Nifedipine (Nifediine) Unspecified C Metoprolol Tartrate (Metoprolol Tartrate) Unspecified C Doxazosin Mesilate (Doxazosin Mesilate) Unspecified C Losartan Potassium (Losartan Potassium) Unspecified C Spironolactone (Spironolactone) Unspecified C Etizolam (Etizolam) Unspecified C Estazolam (Estazolam) Unspecified C Rilmazafone Hydrochloride (Rilmazafone) Unspecified C Date:12/11/03ISR Number: 4251421-1Report Type:Expedited (15-DaCompany Report #200313731GDS Age:63 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:20 AM Page: 1870 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Blood Potassium Increased Foreign Adalat L Bradycardia Literature (Nifedipine) PS ORAL 1740 MG, Cardiac Failure Health TOTAL DAILY, Generalised Oedema Professional ORAL Hypotension Other Seloken (Metoprolol Intentional Overdose Tartrate) SS ORAL 2240 MG, Loss Of Consciousness TOTAL DAILY, Pleural Effusion ORAL Pulmonary Oedema Cadenalin (Doxazosin Shock Mesilate) SS ORAL 86 MG, TOTAL DAILY, ORAL Nu-Lotan (Losartan Potassium) SS ORAL 1500 MG, TOTAL DAILY, ORAL Aldactone-A (Spironolactone) SS ORAL 725 MG, TOTAL DAILY, ORAL Depas (Etizolam) SS ORAL 19.5 MG, TOTAL DAILY, ORAL Eurodin (Estazolam) SS ORAL 52 MG, TOTAL DAILY, ORAL Risperdal (Risperidone) SS ORAL 12 MG, TOTAL DAILY, ORAL Rhythmy (Rilmazafone) SS ORAL 52 MG, TOTAL DAILY, ORAL Date:12/12/03ISR Number: 4250728-1Report Type:Direct Company Report #CTU 207932 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Coronary Syndrome Risperdal 1 Mg Initial or Prolonged Convulsion Janssen PS Janssen ORAL 1 MG BID ORAL Hypertension Fosinopril C Lethargy Novolin N C Aricept C Lorazepam C Date:12/12/03ISR Number: 4251722-7Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20031104422 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal Initial or Prolonged Health (Risperidone) Professional Unspecified PS ORAL 1 MG, 1 IN 1 DAY, ORAL Metamizole (Metamizole) Capsules SS ORAL 500 MG, IN 1 DAY, ORAL Amiodarone (Amiodarone) C Trazodone 22-Feb-2006 08:20 AM Page: 1871 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Trazodone) C Enoxaparine (Heparin-Fraction, Sodium-Salt) C Date:12/12/03ISR Number: 4251724-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031201570 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 3 MG, 1 IN 1 D, ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Vegetamin-B (Vegetamin A) C Perospirone Hydrochloride Hydrate (All Other Therapeutic Products) C Date:12/12/03ISR Number: 4251726-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031201568 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 8 MG, 1 IN 1 DAY, ORAL Haloperidol (Haloperidol) C Zotepine (Zotepine) C Date:12/12/03ISR Number: 4251727-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031201565 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 6 MG, 1 IN 1 DAY, ORAL Haloperidol (Haloperidol) C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Levomepromazine Maleate (Levomepromazine Maleate) C Vegetamin-A (Vegetamin A) C 22-Feb-2006 08:20 AM Page: 1872 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/03ISR Number: 4251830-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031105015 Age:6 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Foreign Risperdal Initial or Prolonged Headache Health (Risperidone) Hyperhidrosis Professional Solution PS ORAL 3 MG, 1 IN 1 Hypothermia DAY, ORAL Medication Error Nausea Overdose Respiratory Depression Somnolence Date:12/12/03ISR Number: 4252189-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031201362 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Date:12/12/03ISR Number: 4252190-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031201350 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 3 MG, 1 IN 1 DAY, ORAL Date:12/12/03ISR Number: 4252191-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031201737 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Tablets PS ORAL 25 MG, 3 IN 1 DAY, ORAL Antihypertensive (Antihypertensives) C Coumadin (Warfarin Sodium) C Ativan (Lorazepam) C Date:12/12/03ISR Number: 4252192-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031201748 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1873 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/03ISR Number: 4252601-1Report Type:Expedited (15-DaCompany Report #BR-JNJFOC-20031104708 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Risperdal Initial or Prolonged Coma Health (Risperidone) Infection Professional Unspecified PS ORAL 2 MG, 1 IN 1 Somnolence DAY, ORAL Date:12/15/03ISR Number: 4252604-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031200297 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Risperdal Initial or Prolonged Medication Error Health (Risperidone) Salivary Hypersecretion Professional Solution PS ORAL , IN 1 DAY, ORAL Date:12/15/03ISR Number: 4252607-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031200290 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Risperidone) Professional Solution PS ORAL 0.25 MG, IN 1 DAY, ORAL Mopral (Omeprazole) C Date:12/15/03ISR Number: 4252610-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031201364 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Neutropenia Health (Risperidone) Professional Unspecified PS ORAL 1 MG, 2 IN 1 DAY, ORAL Date:12/15/03ISR Number: 4252657-6Report Type:Expedited (15-DaCompany Report #NSADSS2003014188 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Victim Of Crime Consumer Risperdal Health (Risperdone) Professional Unspecified PS ORAL ORAL Date:12/16/03ISR Number: 4253582-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031201673 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Reminyl Professional (Galantamine) PS Company Risperdal Representative (Risperidone) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1874 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/03ISR Number: 4253729-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031201204 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Drug Level Increased Health (Risperidone) PS ORAL 2 MG ORAL Extrapyramidal Disorder Professional Fentanyl (Fentanyl) Unspecified SS Date:12/16/03ISR Number: 4253742-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031201204 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Drug Level Increased Health (Risperidone) Extrapyramidal Disorder Professional Unspecified PS ORAL 2 MG; ORAL Femur Fracture Fentanyl (Fentanyl) Unspecified SS UNKNOWN Date:12/16/03ISR Number: 4253804-2Report Type:Expedited (15-DaCompany Report #200313731GDS Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Foreign Adalat L Hospitalization - Coma Literature (Nifedipine) PS ORAL 1740 MG, Initial or Prolonged Generalised Oedema Health TOTAL DAILY, Haemodialysis Professional ORAL Intentional Overdose Other Seloken (Metoprolol Loss Of Consciousness Tartrate) SS ORAL 2240 MG, Pleural Effusion TOTAL DAILY, Pulmonary Oedema ORAL Respiratory Disorder Cardenalin Shock (Doxazosin Mesilate) SS ORAL 86 MG, TOTAL Suicide Attempt DAILY, ORAL Therapy Non-Responder Nu-Lotan (Losartan Potassium) SS ORAL 1500 MG, TOTAL DAILY, ORAL Aldactone-A (Spironolactone) SS ORAL 725 MG, TOTAL DAILY, ORAL Depas (Etizolam) SS ORAL 19.5 MG, TOTAL DALY, ORAL Eurodin (Estazolam) SS ORAL 52 MG, TOTAL DAILY, ORAL Risperdal (Risperidone) SS ORAL 12 MG, TOTAL DAILY, ORAL Rhythmy (Rilmazafone) SS ORAL 52 MG, TOTAL DAILY, ORAL Date:12/16/03ISR Number: 4253874-1Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20031105410 Age:1 MON Gender:Female I/FU:F Outcome PT Other Drug Withdrawal Syndrome Neonatal 22-Feb-2006 08:20 AM Page: 1875 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maternal Drugs Affecting Foetus Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Risperidone) Professional Tablets PS INTRA-UTERINE 4 MG, IN 1 DAY, INTRAUTERINE Zoloft (Sertraline Hydrochloride) C Aurorix (Moclobemide) C Marcain (Bupivacaine Hydrochloride) C Fentanyl (Fentanyl) C Date:12/16/03ISR Number: 4253893-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031202443 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL Date:12/17/03ISR Number: 4253451-2Report Type:Direct Company Report #CTU 208213 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Haloperidol PS Initial or Prolonged Syndrome Risperidone Tab SS ORAL 2 MG PO Required Rhabdomyolysis Dantrolene C Intervention to Clonidine C Prevent Permanent Lorazepam C Impairment/Damage Acetaminophen C Diphenhydramine C Benztropine C Clonazepam C Ziprasidone C Midazolam C Hydrocortisone 1% Cream C Hydroxyzine C Temazepam C Nicotine Polacrilex Gum, Chewable C Trihexyphenidyl C Carbamazepine C Lorazepam C Magnesium Hydroxide C Antacid C Ranitidine C Magnesium Sulfate C .. C Mvi C Thiamine C Folic Acid C 22-Feb-2006 08:20 AM Page: 1876 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/17/03ISR Number: 4253961-8Report Type:Direct Company Report #CTU 208292 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Risperidone PS Initial or Prolonged Somnolence Hydroxyzine C Olanzepine C Folic Aicd C Naproxin C Date:12/17/03ISR Number: 4254307-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031201671 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Risperdal Initial or Prolonged First Degree Health (Risperidone) Blood Pressure Systolic Professional Tablets PS ORAL 1 MG, IN 1 Increased DAY, ORAL Fall Tranxene Malaise (Clorazepate Somnolence Dipotassium) Amp Im SS INTRAMUSCULAR 1 DOSE (S), IN 1 DAY, INTRA-MUSCULA R Sectral (Acebutolol Hydrochloride) SS ORAL 200 MG, IN 1 DAY, ORAL Ikorel (Nicorandil SS 20 MG, 2 IN 1 DAY Date:12/17/03ISR Number: 4254321-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031100928 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) Aspartate Professional Unspecified PS ORAL SEE IMAGE Aminotransferase Levomepromazine Increased Maleate Blood Creatine (Levomepromazine Phosphokinase Increased Maleate) Unknown SS ORAL SEE IMAGE Blood Lactate Bipiriden Dehydrogenase Increased Hydrochloride Catatonia (Biperiden Convulsion Hydrochloride) C Drug Interaction Brotizolam Gastrointestinal (Brotizolam) C Hypomotility Lorazepam Neuroleptic Malignant (Lorazepam) C Syndrome Flunitrazepam Pneumonia Aspiration (Flunitrazepam) C White Blood Cell Count Promethazine Increased Hydrochloride (Promethazine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1877 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/17/03ISR Number: 4254596-3Report Type:Expedited (15-DaCompany Report #NSADSS2002046249 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 1 MG, 2 IN DAY, ORAL Date:12/17/03ISR Number: 4254602-6Report Type:Expedited (15-DaCompany Report #NSADSS2003010108 Age:94 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.25 MG, 2 IN DAY, ORAL Lotrel (Lotrel) C Lanoxin (Digoxin) C Synthroid (Levothyroxine Sodium) C Date:12/19/03ISR Number: 4255444-8Report Type:Direct Company Report #CTU 208452 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Angioneurotic Oedema Risperidone 1 Mg PS ORAL 1 MG BID ORAL Intervention to Generalised Oedema Morphine C Prevent Permanent Fentanyl C Impairment/Damage Morphine C Magnesium Citrate C Docusate C Novolin C Magic Mouthwash C Trazodone C Acetaminophen C Furosemide C Lansoprazole C Insulin Reg C Date:12/19/03ISR Number: 4255446-1Report Type:Direct Company Report #CTU 208450 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Angioneurotic Oedema Risperidone 1 Mg PS ORAL 1 MG BID ORAL Intervention to Generalised Oedema Morphine Inj C Prevent Permanent Fentanyl C Impairment/Damage Morphine C Magnesium Citrate C Docusate C Insulin C Magic Mouthwash C Trazodone C Acetaminophen C Furosemide C Lansoprazole C Novulin C 22-Feb-2006 08:20 AM Page: 1878 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/03ISR Number: 4256380-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031202852 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Foreign Risperdal Initial or Prolonged Health (Risperidone) Professional Unspecified PS 2-6MG Risperdal Constra (Risperidone) Microspheres SS 1 IN 2 WEEK Citalopram (Citalopram) C Orphenadrine (Orphenadrine) C Date:12/19/03ISR Number: 4256406-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031203118 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Foreign Risperdal Initial or Prolonged Health (Risperidone) Professional Unspecified PS ORAL 9 MG, IN 1 DAY, ORAL Date:12/19/03ISR Number: 4256409-2Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20031202462 Age:75 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Study (Risperidone) Health Unspecified PS Professional Date:12/19/03ISR Number: 4256413-4Report Type:Expedited (15-DaCompany Report #CZ-JNJFOC-20031203207 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Insipidus Foreign Risperdal Health (Risperidone) Professional Tablets PS ORAL 4 MG, IN 1 DAY, ORAL Tisercin (Levomepromazine) C Rivotril (Clonazepam) C Mucosolvan (Ambroxol Hydrochloride) C Zinnat (Cefuroxime Axetil) C Ofloxin (Ofloxacin) C Fraxiparine (Heparin-Fraction, Calcium Salt) C Warfarin (Warfarin) C 22-Feb-2006 08:20 AM Page: 1879 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/03ISR Number: 4256416-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031105447 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extradural Haematoma Foreign Risperdal Initial or Prolonged Fall Health (Risperidone) Hallucination Professional Unspecified PS ORAL 8 MG, IN 1 Medication Error DAY, ORAL Psychotic Disorder Zyprexa (Olanzapine) C Radius Fracture Date:12/19/03ISR Number: 4256419-5Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20030806152 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Risperdal Cardiomegaly Health (Risperidone) Cardiomyopathy Professional Tablets PS ORAL 2 MG, 2 IN 1 Fatigue DAY, ORAL Mania Epilim (Valproate Pulmonary Hypertension Sodium) Unknown SS 2000 MG, IN 1 DAY Lipitor (Atorvastatin) C Aspirin (Acetylsalicylic Acid) C Oroxine (Levothyroxine Sodium) C Date:12/19/03ISR Number: 4256564-4Report Type:Expedited (15-DaCompany Report #NSADSS2002009796 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Consumer Risperdal Health (Risperidone Tablets PS ORAL 1 MG, 1 IN 1 Professional DAY, ORAL; 0.5 MG, 1 IN 1 DAY, ORAL; ORAL Synthroid (Levothyroxine Sodium) C Restoril (Temazepam) C Date:12/19/03ISR Number: 4256565-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030707355 Age:16 YR Gender:Male I/FU:F Outcome PT Death Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Creatine Phosphokinase Increased Blood Glucose Increased Blood Pressure Abnormal 22-Feb-2006 08:20 AM Page: 1880 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Sodium Decreased Cardio-Respiratory Arrest Hyperpyrexia Report Source Product Role Manufacturer Route Dose Duration Loss Of Consciousness Health Risperdal Myoglobin Blood Increased Professional (Risperidone) Shock Tablets PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Topamax (Topiramate) Unspecified SS 100 MG, 2 IN 1 DAY Valproic Acid (Valproic Acid) SS 125 MG, 8 IN 1 DAY Date:12/22/03ISR Number: 4257244-1Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20031202462 Age:75 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Metastatic Neoplasm Foreign Risperdal Study (Risperidone) Health Unspecified PS Professional Date:12/22/03ISR Number: 4257249-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031202796 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 2 MG, IN 1 DAY, ORAL Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Bromperidol (Bromperidol) C Date:12/22/03ISR Number: 4257516-0Report Type:Expedited (15-DaCompany Report #2003AP04360 Age:20 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Quetiapine PS Health Risperidone SS Professional Valproic Acid SS Date:12/22/03ISR Number: 4257777-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031203027 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Company Unspecified PS Representative 22-Feb-2006 08:20 AM Page: 1881 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/03ISR Number: 4257978-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031201565 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Risperdal Pulmonary Embolism Health (Risperidone) Professional Unspecified PS ORAL 6 MG, IN 1 DAY, ORAL Haloperidol (Haloperidol) Unspecified SS ORAL 18 MG, IN 1 DAY, ORAL Levomepromazine Maleate SS ORAL 150 MG, IN 1 DAY, ORAL Levomepromazine Maleate (Levomepromazine Maleate) Unspecified SS ORAL 50 MG, IN 1 DAY, ORAL Vegetamin-A (Vegetamin A) Unspecified SS ORAL 1 DOSE (S), IN 1 DAY, ORAL Trixhexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) Unspecified C Nitrazepam (Nitrazepam) Unspecified C Brotizolam (Brotizolam) Unspecified C Date:12/23/03ISR Number: 4257979-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031202866 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Allergic Oedema Foreign Risperidone Initial or Prolonged Study (Risperidone) Health Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Professional WEEK, INTRA-MUSCULA R; 37.5 MG, 1 IN 2 WEEK, Date:12/23/03ISR Number: 4257984-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031203546 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akinesia Foreign Risperdal Depression Health (Risperidone) Drug Level Increased Professional Unspecified PS ORAL 2.5 MG , IN 1 Extrapyramidal Disorder DAY, ORAL Masked Facies Paroxetin(Paroxetine ) C 22-Feb-2006 08:20 AM Page: 1882 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/03ISR Number: 4257990-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031203402 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Abscess Foreign Risperdal Initial or Prolonged Galactorrhoea Health (Risperidone) Hyperprolactinaemia Professional Tablets PS ORAL 4 MG, IN 1DAY, ORAL Date:12/23/03ISR Number: 4257993-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031203551 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Risperdal Increased Health (Risperidone) Erectile Dysfunction Professional Unspecified PS ORAL 4 MG, IN 1 Hepatic Cirrhosis DAY, ORAL Hepatic Steatosis Weight Increased Date:12/23/03ISR Number: 4257996-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031203345 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Risperdal Increased Health (Risperidone) Diabetes Mellitus Professional Unspecified PS ORAL 2 MG, IN 1 Inadequate Control DAY, ORAL Hepatic Function Abnormal Levomepromazine Hepatic Steatosis Maleate Polydipsia (Levomepromazine Weight Increased Maleate) Unspecified SS ORAL 25 MG, IN 1 DAY, ORAL Paroxetine Hydrochloride Hydrate SS ORAL 50 MG, IN 1 DAY, ORAL Paroxetine Hydrochloride Hydrate (Paroxetine) Unspecified SS ORAL 20 MG, IN 1 DAY, ORAL Promethazine Hydrochloride (Promethazine Hydrochloride) Unspecified SS Triazolam (Triazolam) Unspecified C Lomerizine Hydrochloride (All Other Therapeutic Products) Unspecified C Famotidine(Famotidin e) Unspecified C 22-Feb-2006 08:20 AM Page: 1883 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/03ISR Number: 4257997-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031201570 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 3 MG, IN 1 DAY, ORAL Chlorpromazine Hydrochloride(Chlorp romazine Hydrochloride) Unspecified SS ORAL 25 MG, IN 1 DAY, ORAL Vegetamin -B (Vegetamin A) Unspecified SS ORAL 1 DOSE (S), IN 1 DAY, ORAL Perospirone Hydrochlorde Hydrate (All Other Therapeutic Products) SS ORAL 24 MG, IN 1 DAY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride)Unspec ified C Brotizolam (Brotizolam) Unspecified C Etizolam (Etizolam) Unspecified C Lithium Carbonate (Lithium Carbonate) Unspecified C Date:12/23/03ISR Number: 4257999-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031201565 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Risperdal Respiratory Arrest Health (Risperidone) Professional Unspecified PS ORAL 6 MG, IN 1 DAY, ORAL Haloperidol (Haloperidol) Unspecified SS ORAL 18 MG, IN 1 DAY, ORAL Levomepromazine Maleate SS ORAL 150 MG, IN 1 DAY, ORAL Levomepromazine Maleate (Levomepromazine Maleate) Unspecified SS ORAL 50 MG, IN 1 DAY, ORAL Vegetamin-A (Vegetamin A) 22-Feb-2006 08:20 AM Page: 1884 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unspecified SS ORAL 1 DOSE(S), IN 1 DAY, ORAL Chlorpromazine Hydrochloride( Chlorpromazine Hydrochloride) Unspecified SS Trihexyphenidyl Hydrochloride(Trihex yphenidyl Hydrochloride) Unspecified C Nitrazepam (Nitrazepam) Unspecified C Brotizolam (Brotizolam) Unspecifided C Date:12/23/03ISR Number: 4258257-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030800610 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colitis Consumer Risperdal Condition Aggravated Health (Risperidone) Depressed Mood Professional Tablets PS ORAL 0.5 MG, 3 IN Insomnia 1 DAY, ORAL Coumadin (Warfarin Sodium) C Nataral (Nataral) C Abapro (Irbesartan) C Lasix (Furosemide) C Potassium (Potassium) C Date:12/24/03ISR Number: 4260286-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12321618 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Cholesterol Pravachol PS Bristol-Myers Squibb Increased Company ORAL Weight Increased Risperdal SS Gemfibrozil C Date:12/26/03ISR Number: 4259784-8Report Type:Expedited (15-DaCompany Report #NSADSS2003014805 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL 1 MG, 1 IN 1 DAY, ORAL Pamelor (Nortriptyline Hydrochloride) C Prinizide (Prinzide) C Zocor (Simvastatin) C 22-Feb-2006 08:20 AM Page: 1885 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/26/03ISR Number: 4259785-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20031204106 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Consumer Risperdal Myocardial Infarction Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:12/26/03ISR Number: 4259786-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031204110 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:12/26/03ISR Number: 4259793-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031203879 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL 1 MG, 2 IN 1 DAY, ORAL Date:12/26/03ISR Number: 4259795-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031203831 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL Date:12/26/03ISR Number: 4259797-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031204057 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Company Unspecified PS ORAL ORAL Representative Date:12/26/03ISR Number: 4259798-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031203854 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL Date:12/26/03ISR Number: 4259799-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20030902178 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Death Death Consumer Health 22-Feb-2006 08:20 AM Page: 1886 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal (Risperidone) Unspecified PS Date:12/26/03ISR Number: 4260718-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031201568 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperdal Deep Vein Thrombosis Health (Risperidone) PS ORAL 8 MG, IN 1 Pulmonary Embolism Professional DAY, ORAL Haloperidol (Haloperidol) Unspecified SS ORAL 1.6 MG, IN 1 DAY, ORAL Zotepine (Zotepine) Unspecified SS ORAL 500 MG, IN 1 DAY, ORAL Levomepromazine Maleate SS ORAL 500 MG, IN 1 DAY, ORAL Carbamazepine (Carbmazepine) Unspecified C Biperiden Hydrochloride (Biperiden Hydrochloride) C Bromazepam (Bromazepam) Unspecified C Teprenone (Teprenone) Unspecified C Gentian (Gentian) Unspecified C Sodium Bicarbonate (Sodium Bicarbonate) Unspecified C Date:12/26/03ISR Number: 4260901-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031201568 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperdal Deep Vein Thrombosis Health (Risperidone) PS ORAL 8 MG, IN 1 Pulmonary Embolism Professional DAY, ORAL Haloperidol (Haloperidol) SS ORAL 1.6 MG, IN 1 DAY, ORAL Zotepine (Zotepine) SS ORAL 500 MG, IN 1 DAY, ORAL Levomepromazine Maleate (Levomepromazine Maleate) SS ORAL 50 MG, 1 IN 1 22-Feb-2006 08:20 AM Page: 1887 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY, ORAL Carbamazepine (Carbamazepine) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Bromazepam (Bromazepam) C Teprenone (Teprenone) C Gentian (Gentian) C Sodium Bicarbonate (Sodium Bicarbonate) C Date:12/29/03ISR Number: 4260063-3Report Type:Direct Company Report #USP 041900 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Prinivil PS Merck TABLET Risperdal SS Janssen TABLET Date:12/29/03ISR Number: 4260697-6Report Type:Direct Company Report #USP 041867 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Risperdal PS Janssen TABLET Date:12/29/03ISR Number: 4261121-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031103549 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Risperdal Initial or Prolonged Agitation Health (Risperidone) Asthenia Professional Solution PS ORAL SEE IMAGE Automatism Levothyrox Confusional State (Levothyroxine Disorientation Sodium) C Drug Ineffective Seropram (Citalopram Dyspnoea Hydrobromide) C Hallucination Lepticur Persecutory Delusion (Tropatepine Pyrexia Hydrochloride) C Rhabdomyolysis Date:12/29/03ISR Number: 4261190-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031105516 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disease Recurrence Foreign Risperdal Consta Life-Threatening Feeling Abnormal Health (Risperidone) Hospitalization - Intestinal Infarction Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Initial or Prolonged Malaise WEEK, Mental Disorder INTRA-MUSCULA Schizoaffective Disorder R Sepsis Lithium (Lithium) SS 1000 MG, 1 IN Treatment Noncompliance 1 DAY, Chlorpromazine 22-Feb-2006 08:20 AM Page: 1888 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Chlorpromazine) C Aspirin (Acetylsalicylic Acid) C Ferrous Sulphate (Ferrous Sulfate) C Date:12/29/03ISR Number: 4261192-0Report Type:Expedited (15-DaCompany Report #NSADSS2003008397 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperdal Hospitalization - Pulmonary Embolism Literature (Risperidone) PS ORAL 3 MG, IN 1 Initial or Prolonged Health DAY, ORAL Professional Bromperidol (Bromperidol) SS 18 MG Lorazepam (Lorazepam) Tablets C Estazolam (Estazolam) Tablets C Biperiden Hydrochloride (Biperiden Hydrochloride) C Etizolam (Etizolam) C Lormetazepam (Lormetazepam) C Date:12/29/03ISR Number: 4261194-4Report Type:Expedited (15-DaCompany Report #PT-JNJFOC-20031204465 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Foreign Risperdal Non-Insulin-Dependent Health (Risperidone) PS ORAL 7.5 MG, IN 1 Professional DAY, ORAL Mutabon-F (Etrafon-D) Tablets C Date:12/29/03ISR Number: 4261196-8Report Type:Expedited (15-DaCompany Report #CZ-JNJFOC-20031203207 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Insipidus Foreign Risperdal Initial or Prolonged Embolism Health (Risperidone) Other Pneumonia Professional Tablets PS ORAL 4 MG, IN 1 DAY, ORAL Tisercin (Levomepromazine) C Rivotril (Clonazepam) C Mucosolvan (Ambroxol Hydrochloride) C Zinnat (Cefuroxime Axetil) C Ofloxacin (Ofloxacin) C Fraxiparine (Heparin-Fraction, Calcium Salt) C 22-Feb-2006 08:20 AM Page: 1889 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Warfarin (Warfarin) C Date:12/29/03ISR Number: 4261198-1Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20031200306 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Risperdal Initial or Prolonged Aminotransferase Health (Risperidone) PS ORAL 0.5 MG, ORAL Increased Professional Trombyl Confusional State (Acetylsalciylic Escherichia Infection Acid) Tablets C Fall Triobe (Triobe) Personality Disorder Tablets C Tachycardia Urinary Tract Infection Date:12/29/03ISR Number: 4261201-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031101807 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Chronic Obstructive Health (Risperidone) PS ORAL 0.5 MG, 2 IN Pulmonary Disease Professional 1 DAY, ORAL Pneumonia Aspiration Aspirin Somnolence (Acetylsalicylic Acid) SS 75 MG, IN 1 DAY Iron (Iron) SS Folic Acid (Folic Acid) C Augmentin (Clavulin) C Date:12/29/03ISR Number: 4261205-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031100365 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Major Depression Foreign Risperdal Suicide Attempt Health (Risperidone) PS ORAL 2 MG, 3 IN 1 Professional DAY, ORAL Date:12/29/03ISR Number: 4261324-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031204167 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Foreign Reminyl (Galantamin) PS ORAL 16 MG, ORAL Supraventricular Health Risperdal Blood Creatine Professional (Risperidone) SS ORAL 3 MG, ORAL Phosphokinase Increased Date:12/29/03ISR Number: 4261578-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030906219 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lipase Increased Foreign Risperdal Initial or Prolonged Health (Risperidone) Professional Tablets PS ORAL 8 MG, IN 1 22-Feb-2006 08:20 AM Page: 1890 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY, ORAL Date:12/29/03ISR Number: 4261726-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030707355 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alanine Aminotransferase Health Risperdal Increased Professional (Risperidone) Aspartate Tablets PS ORAL 0.5 MG, 2 IN Aminotransferase 1 DAY, ORAL Increased Topamax (Topiramate) SS 100 MG, 2 IN Bilirubin Conjugated 1 DAY Increased Valproic Acid Blood Albumin Decreased (Valproic Acid) SS 125 MG, 8 IN Blood Bicarbonate 1 DAY Decreased Blood Bilirubin Increased Blood Bilirubin Unconjugated Increased Blood Calcium Decreased Blood Creatine Phosphokinase Increased Blood Glucose Increased Blood Potassium Decreased Blood Sodium Decreased Cardio-Respiratory Arrest Drug Level Decreased Hyperthermia Labile Blood Pressure Loss Of Consciousness Myoglobin Blood Increased Po2 Protein Total Decreased Troponin Increased Date:12/29/03ISR Number: 4261733-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030707355 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Health Risperdal Phosphokinase Increased Professional (Risperidone) Blood Pressure Tablets PS ORAL 0.5 MG, 2 IN Fluctuation 1 DAY, ORAL Blood Sodium Decreased Topamax (Topiramate) Cardio-Respiratory Arrest Unspecified SS 100 MG, 2 IN Hyperthermia 1 DAY Loss Of Consciousness Valproic Acid Myoglobin Blood Increased (Valproic Acid) SS 125 MG, 8 IN 1 DAY Date:12/30/03ISR Number: 4261780-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031102953 Age:45 YR Gender:Female I/FU:F Outcome PT Death Alanine Aminotransferase Hospitalization - Increased Initial or Prolonged Aspartate Aminotransferase Increased 22-Feb-2006 08:20 AM Page: 1891 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Lactate Dehydrogenase Increased Brain Death Report Source Product Role Manufacturer Route Dose Duration Cardio-Respiratory Arrest Foreign Risperdal Conversion Disorder Health (Risperidone) Dizziness Professional Tablets PS ORAL 2 MG, 2 IN 1 Drug Interaction DAY, ORAL Electrocardiogram Vegetamin-A Abnormal (Vegetamin A) Fall Tablets SS ORAL 1 DOSE (S), 1 Heart Rate Increased IN 1 DAY, Hepatic Function Abnormal ORAL Hypoxic Encephalopathy Haloperidol Incontinence (Haloperidol) SS Mental Disorder Flunitrazepam Pupil Fixed (Flunitrazepam) SS ORAL 2 MG, IN 1 Pupillary Reflex Impaired DAY, ORAL Syncope Ventricular Fibrillation Date:12/30/03ISR Number: 4261781-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031201570 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Risperdal Hospitalization - Health (Risperidone) Initial or Prolonged Professional Unspecified PS ORAL 3 MG, IN 1 DAY, ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) SS ORAL 25 MG, IN 1 DAY, ORAL Vegetamin-B (Vegetamin A) SS ORAL 1 DOSE (S), IN 1 DAY, ORAL Perospirone Hydrochloride Hydrate SS Biperiden Hydrochloride C Etizolam C Lithium Carbonate C ... C Date:12/30/03ISR Number: 4261960-5Report Type:Expedited (15-DaCompany Report #NSADSS2002043527 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 1 IN 24 HOUR, ORAL 22-Feb-2006 08:20 AM Page: 1892 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/03ISR Number: 4261972-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031103373 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Unevaluable Event Consumer Risperdal Health (Risperidone) Professional Unspecified PS 3 MG, 1 IN 1 DAY Etodolac (Etodolac) C Phenabarbital (Barbiturates) C Neurontin (Gabapentin) C Dilantin (Phenytoin Sodium) C Phenergan (Promethazine Hydrochloride) C Lorazepam (Lorazepam) C Hydrocodone (Hydrocodone) C Tegretal (Carbamazepine) C Date:12/30/03ISR Number: 4261976-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030906343 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Internal Injury Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Date:12/30/03ISR Number: 4262499-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031102953 Age:45 YR Gender:Female I/FU:F Outcome PT Death Alanine Aminotransferase Hospitalization - Increased Initial or Prolonged Aspartate Aminotransferase Increased Blood Pressure Diastolic Decreased Brain Death Cardio-Respiratory Arrest Conversion Disorder Dizziness Drug Interaction Fall Headache Heart Rate Increased Hypoxic Encephalopathy Incontinence Infection Loss Of Consciousness Mental Disorder Pupil Fixed Pupillary Reflex Impaired 22-Feb-2006 08:20 AM Page: 1893 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syncope Ventricular Fibrillation Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Risperidone) Professional Tablets PS ORAL 2 MG, 2 IN 1 DAY, ORAL Vegetamin-A (Vegetamin A) Tablets SS ORAL 1 DOSE(S), 1 IN 1 DAY, ORAL Haloperidol (Haloperidol) SS Flunitrazepam (Flunitrazepam) SS ORAL 2 MG, IN 1 DAY, ORAL Date:12/30/03ISR Number: 4266748-7Report Type:Periodic Company Report #HQ5919627DEC2002 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Consumer Effexor Xr Depressed Mood (Venlafaxine Drug Withdrawal Syndrome Hydrochloride, Hypersomnia Extended Release) PS ORAL 800 MG 1X PER 1 DAY, ORAL Risperdal (Risperidone, ) SS 1 MG 1X PER 1 DAY Seroquel (Quetiapine,) SS 50 MG 1X PER 1 DAY Trazodone (Trazodone, ) SS AS NEEDED Vitamins (Vitamins, ) SS Date:12/31/03ISR Number: 4262509-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031003238 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Emphysema Health Risperdal Pneumonia Professional (Risperidone) Tablets PS ORAL Date:12/31/03ISR Number: 4262510-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20031204663 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Company Tablets PS ORAL 0.25 MG, 1 IN Representative 1 D, ORAL 22-Feb-2006 08:20 AM Page: 1894 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/31/03ISR Number: 4262528-7Report Type:Expedited (15-DaCompany Report #S03-USA-02427-01 Age:10 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Subcapsular Health Celexa(Citalopram Required Drug Ineffective Professional Hydrobromide) PS ORAL 10 MG QD PO Intervention to Company Risperdal Prevent Permanent Representative (Risperidone) SS Impairment/Damage Steroids C Date:12/31/03ISR Number: 4262668-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031204467 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Risperdal Initial or Prolonged Agitation Health (Risperidone) PS ORAL SEE IMAGE Blood Creatine Professional Temazepam Phosphokinase Increased (Temazepam) C Hypertonia Mutism Pyrexia Date:12/31/03ISR Number: 4262824-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031201565 Age:51 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apnoea Foreign Risperdal Hospitalization - Pulmonary Embolism Health (Risperidone) Initial or Prolonged Professional Unspecified PS ORAL 6 MG, IN 1 DAY, ORAL Haloperidol (Haloperidol) Unspecified SS ORAL 18 MG, IN 1 DAY, ORAL Levomepromazine Maleate SS ORAL 150 MG, IN 1 DAY, ORAL Levomepromazine Maleate (Levomepromazine Maleate)Unspecified SS ORAL 50 MG, IN 1 DAY, ORAL Vegetamin -A(Vegetamin A) Unspecified SS ORAL 1 DOSE (S), IN 1 DAY, ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloried) Unspecified SS Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloried)Unspec ified C Nitrazepam (Nitrazepam) Unspecified C 22-Feb-2006 08:20 AM Page: 1895 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Brotizolam (Brotizolam) Unspedified C Date:12/31/03ISR Number: 4262887-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031201568 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Risperdal Hospitalization - Deep Vein Thrombosis Health (Risperidone) PS ORAL 8 MG, IN 1 Initial or Prolonged Pulmonary Embolism Professional DAY, ORAL Other Haloperidol (Haloperidol) Unspecified SS ORAL 1.6 MG, IN 1 DAY, ORAL Zotepine (Zotepine) Unspecified SS ORAL 500 MG, IN 1 DAY, ORAL Levomepromazine Maleate (Levomepromazine Maleate) SS ORAL 50 MG, IN 1 DAY, ORAL Carbamazepine (Carbamazepine) Unspecified C Biperiden Hydrochloride (Biperiden Hydrochloride) C Bromazepam (Bromazepam) Unspecified C Teprenone (Teprenone) Unspecified C Gentian (Gentian) Unspecified C Sodium Bicarbonate (Sodium Bicarbonate) Unspecified C Date:01/02/04ISR Number: 4263652-5Report Type:Expedited (15-DaCompany Report #USA031254590 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catheter Related Consumer Humulin-Human Initial or Prolonged Infection Regular Insulin Other Dizziness (Rdna) (Human Urinary Tract Infection Insulin PS Zyprexa-Oral (Olanzapine) (Olanzapine) SS 15 MG/AT BEDTIME Risperdal (Risperidone) SS Lantus (Insulin Glargine) C 22-Feb-2006 08:20 AM Page: 1896 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/02/04ISR Number: 4263674-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031204590 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombosis Foreign Risperdal Initial or Prolonged Study (Risperidone) Health Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Professional WEEK, INTRA-MUSCULA R; 37.5 MG, 1 IN 2 WEEK, Risperdal (Risperidone) Unspecified C Date:01/02/04ISR Number: 4263678-1Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20031006430 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Galactorrhoea Foreign Risperdal Metrorrhagia Health (Risperidone) Urinary Incontinence Professional Unspecified PS ORAL 0.5 MG, 1 IN Vomiting 1 DAY, ORAL Sertraline (Sertraline) Unknown C Date:01/02/04ISR Number: 4263713-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031201566 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Risperdal Initial or Prolonged Blood Creatine Health (Risperidone) Other Phosphokinase Increased Professional Unspecified PS ORAL DOSE=1-2 MG; Condition Aggravated 4 MG, IN 1 Dizziness DAY, ORAL Gait Disturbance Paroxetine Hypoaesthesia Hydrochloride Irritability Hydrate (Paroxetine) Malaise Unspecified SS ORAL ORAL; SEE Myoclonus IMAGE Obsessive-Compulsive Vegetamin-B Disorder (Tablets) Vegetamin Pharyngolaryngeal Pain A C Pyrexia Diazepam Serotonin Syndrome (Unspecified) Upper Respiratory Tract Diazepam C Infection Biperiden Urinary Incontinence Hydrochloride C Lactated Ringer'S Solution (Ringer "Merck") Solution C Cold Medicine (Cold Capsules) Tablets C 22-Feb-2006 08:20 AM Page: 1897 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/05/04ISR Number: 4263508-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12423612 Age:59 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Catatonia Abilify Tabs 30 Mg PS Otsuka Hospitalization - Coma Pharmaceutical Initial or Prolonged Ejection Fraction Company, Ltd. ORAL Decreased Abilify Tabs 30 Mg SS Otsuka Electrocardiogram Qt Pharmaceutical Prolonged Company, Ltd. ORAL Embolic Stroke Risperdal SS Grand Mal Convulsion Norvasc C International Normalised Coumadin C Bristol-Myers Squibb Ratio Decreased Company Respiratory Acidosis Potassium C Torsade De Pointes Lasix C Glipizide C Prozac C Coreg C Date:01/05/04ISR Number: 4263817-2Report Type:Direct Company Report #CTU 209296 Age:12 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Health Risperidone PS ORAL 1.5 MG PO BID Professional Divalproex Sodium C Trazodone C Date:01/06/04ISR Number: 4265567-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031105157 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone ) PS ORAL ORAL Date:01/06/04ISR Number: 4266124-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031102954 Age:25 YR Gender:Female I/FU:F Outcome PT Death Alanine Aminotransferase Hospitalization - Increased Initial or Prolonged Apnoea Arrhythmia Aspartate Aminotransferase Increased Blood Amylase Increased Blood Creatine Phosphokinase Increased Blood Potassium Increased Blood Pressure Decreased Blood Sodium Decreased Blood Sodium Increased Blood Urea Increased Brain Stem Auditory Evoked Response Abnormal Cardio-Respiratory Arrest Hypoxic Encephalopathy Mydriasis 22-Feb-2006 08:20 AM Page: 1898 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pupillary Reflex Impaired Shock Sleep Apnoea Syndrome Report Source Product Role Manufacturer Route Dose Duration Snoring Foreign Risperdal White Blood Cell Count Health (Risperidone) Increased Professional Unspecified PS ORAL 2 MG, IN 1 DAY, ORAL Ofloxacin (Ofloxacin) C Suplatast Tosilate (Suplatast Tosilate) C Ursodexoycholic Acid (Ursodeoxycholic Acid) C Theophylline (Theophylline) C Tulobuterol (Tulobuterol) C Date:01/06/04ISR Number: 4266136-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031201364 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Neutropenia Health (Risperidone) Professional Unspecified PS ORAL 1 MG, 2 IN 1 DAY, ORAL Lorazepam (Lorazepam) C Date:01/06/04ISR Number: 4266140-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031105492 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Extrasystoles Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 1 MG, IN 1 DAY, ORAL Date:01/07/04ISR Number: 4267002-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20031205532 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Consumer Risperdal Hip Fracture Health (Risperidone) Professional Unspecified PS ORAL 5 MG, 2 IN 1 DAY, ORAL; 0.25 MG, 1 IN 1 DAY, ORAL Reminyl (Galantamine) Unspecified SS ORAL 8 MG, 2 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1899 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/04ISR Number: 4267004-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040100080 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Consumer Risperdal (Risperidone) Tablets PS ORAL 2 MG, 1 IN 3 DAY, ORAL Date:01/07/04ISR Number: 4267008-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040100069 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Exelon (Rivastigmine Tartrate) C Date:01/07/04ISR Number: 4267011-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040100055 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Company Unspecified PS ORAL 5 MG, IN 1 Representative DAY, ORAL Date:01/08/04ISR Number: 4268696-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040100191 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Influenza Consumer Risperdal Pneumonia Health (Risperidone) Professional Unspecified PS Date:01/08/04ISR Number: 4268699-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040100237 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, 2 IN 1 DAY, ORAL Date:01/08/04ISR Number: 4268736-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040100268 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL 3 MG, IN 1 DAY ORAL 22-Feb-2006 08:20 AM Page: 1900 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/08/04ISR Number: 4268737-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040100275 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 1 MG 2 IN 1 DAY ORAL Date:01/08/04ISR Number: 4268738-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040100450 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiovascular Disorder Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 1 MG 1 IN 1 DAY ORAL Aricept (Donepezil Hydrochloride) Tablets C Date:01/08/04ISR Number: 4268743-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031205368 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Consumer Duragesic (Fentanyl) Renal Failure Health Patch PS TRANSDERMAL TRANSDERMAL Professional Risperdal (Risperidone) Tablets SS ORAL 1 MG , 2 IN 24 HOUR, ORAL Date:01/08/04ISR Number: 4269428-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031205200 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Risperdal Consta Initial or Prolonged Diplegia Consumer (Risperidone) Fear Microspheres PS INTRAMUSCULAR SEE IMAGE, Nervousness INTRAMUSCULAR Tafil (Alprazolam) C Tavor (Lorazepam) C Date:01/09/04ISR Number: 4268043-9Report Type:Direct Company Report #CTU 209591 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Risperidone Soln, Hallucination Oral 1mg/1ml PS ORAL 1MG PRN ORAL Acetic Acid 0.25% Soln C Chlorophyll/Papain/U rea C Clotrimazole 1% Cr Cream C Heparin C Hydrochlorothiazide C Hydrocortisone 1% Cr 22-Feb-2006 08:20 AM Page: 1901 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cream C Levothyroxine C Linezolid C Lisinopril C Lorazepam C Morphine C Date:01/09/04ISR Number: 4268820-4Report Type:Expedited (15-DaCompany Report #JP-34820 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Foreign Risperdal Exposure To Therapeutic Health (Risperidone) Drugs Professional Unspecified PS ORAL 1 MG, 1 IN 1 Congenital Anomaly DAY, ORAL Dysplasia Lepticur Ear Disorder (Tropatepine Facial Dysmorphism Hydrochloride) C Gestational Diabetes Largactil Maternal Drugs Affecting (Chlorpromazine Foetus Hydrochloride) C Oesophageal Atresia Tranxene Polyhydramnios (Clorazepate Pregnancy Dipotassium) C Umbilical Cord Subutex Abnormality (Buprenorphine Hydrochloride) C Date:01/09/04ISR Number: 4268821-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031005106 Age:20 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Risperdal Complications Of Maternal Health (Risperdal) PS ORAL SEE IMAGE Exposure To Therapeutic Professional Largactil Drugs Other (Chlorpromazine Maternal Drugs Affecting Hydrochloride) C Foetus Pregnancy Date:01/09/04ISR Number: 4268822-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031104156 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Foreign Risperdal Initial or Prolonged Supraventricular Health (Risperidone) Extrasystoles Professional Tablets PS ORAL SEE IMAGE Ventricular Extrasystoles Elisor (Pravastatin Sodium) C Lexomil (Bromazepam) C Date:01/09/04ISR Number: 4268823-XReport Type:Expedited (15-DaCompany Report #FI-JNJFOC-20040100034 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Foreign Risperdal Neuroleptic Malignant Health (Risperidone) Syndrome Professional Tablets PS ORAL SEE IMAGE 22-Feb-2006 08:20 AM Page: 1902 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Akineton (Tablets) Biperiden Hydrochloride C Date:01/09/04ISR Number: 4268925-8Report Type:Expedited (15-DaCompany Report #200410005BNE Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Aspirin Other Pneumonia Aspiration Health (Acetylsalicylic Somnolence Professional Acid) PS 75 MG, TOTAL Other DAILY Risperdal (Risperidone) SS ORAL 0.5 MG, BID, ORAL Iron SS Folic Acid C Augmentin C Date:01/09/04ISR Number: 4269659-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040100856 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperdal) Tablets PS ORAL 1 MG, 2 IN 1 DAY, ORAL Synthroid () Levothyroxine Sodium C Dilantin () Phenytoin Sodium C Date:01/09/04ISR Number: 4269660-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040100835 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Risperdal Medication Error (Risperidone) Murder Tablets PS ORAL ORAL Depakote (Valproate Semisodium) C Date:01/09/04ISR Number: 4269661-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040100453 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone)Tablets PS ORAL 0.75 MG, IN 1 DAY, ORAL Date:01/09/04ISR Number: 4269662-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031105229 Age:90 YR Gender:Female I/FU:F Outcome PT Report Source Hospitalization - Apnoea Health Initial or Prolonged Tongue Paralysis Professional Company 22-Feb-2006 08:20 AM Page: 1903 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Risperdal (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Date:01/09/04ISR Number: 4269663-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030906354 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Risperdal Health (Risperidone) PS Professional Hydroxyzine (Hydroxyzine) C Benztropine (Benzatropine Mesilate) C Geodon (Ziprasidone Hydrochloride) C Trazodone (Trazodone) C Zoloft (Sertraline Hydrochloride) C Date:01/12/04ISR Number: 4269606-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031104108 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Risperidone) PS ORAL ORAL Professional Date:01/12/04ISR Number: 4269685-7Report Type:Expedited (15-DaCompany Report #US-JNJF0C-20030901354 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Risperdal Decreased Professional (Risperidone) Tablets PS ORAL 2.5 MG, 1 IN 1 DAY, ORAL Nadolol (Nadolol) C Date:01/13/04ISR Number: 4271535-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040100037 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ileus Foreign Risperdal Health (Risperidone) PS SEE IMAGE Professional Seroquel (Quetiapine Fumarate) SS SEE IMAGE Tavor (Lorazepam) C 22-Feb-2006 08:20 AM Page: 1904 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/04ISR Number: 4271541-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031002457 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Increased Foreign Risperdal Leukopenia Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) SS ORAL 8 MG, IN 1 DAY, ORAL Ergenyl (Valproate Sodium) C Date:01/13/04ISR Number: 4271944-9Report Type:Expedited (15-DaCompany Report #DEWYE499408JAN04 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Study Tavor (Lorazepam, Initial or Prolonged Increased Unspec) PS ORAL SEE IMAGE 10 DAY Drug Interaction Beloc Zok Gamma-Glutamyltransferase (Metoprolol Increased Succinate, , 0) SS ORAL 47.5 & 95MG Hepatic Enzyme Increased 1X PER 1 DAY ORAL 6 DAY Remergil (Mirtazapine, , 0) SS ORAL 15 & 45 MG 1 X PER 1 DAY ORAL 14 DAY Risperdal (Risperidone, , 0) SS ORAL 2 MG 1X PER 1 DAY ORAL Trevilor (Venlafaxine Hydrochloride, Tablet, 0) SS ORAL SEE IMAGE 12 DAY Quilonum - Slow Release (Lithium Carbonate) C Chloraldurat (Chloral Hydrate) C Date:01/14/04ISR Number: 4272221-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040101527 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Risperdal Consta Professional (Risperidone) Microspheres PS 25 MG, INJECTION Date:01/14/04ISR Number: 4272235-2Report Type:Expedited (15-DaCompany Report #S03-USA-04093-01 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Lexapro Initial or Prolonged Pulmonary Embolism Professional (Escitalopram) PS ORAL 10 MG QD PO 22-Feb-2006 08:20 AM Page: 1905 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lexapro (Escitalopram) SS ORAL 20 MG QD PO Lexapro(Escitalopram ) SS ORAL 10 MG QD PO Risperdal(Risperidon e) SS 2.5 MG QD Lithium SS 1500 MG QD Date:01/14/04ISR Number: 4272530-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040101307 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:01/14/04ISR Number: 4272558-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040101515 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Date:01/14/04ISR Number: 4272559-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040101396 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Risperdal Congestive (Risperidone) Pneumonia Tablets PS ORAL 2 MG, 2 IN 1 DAY, ORAL Date:01/14/04ISR Number: 4272560-5Report Type:Expedited (15-DaCompany Report #NSADSS2003019994 Age:63 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Amyotrophic Lateral Health Risperdal Sclerosis Professional (Risperidone) Aphasia Unspecified PS LOW DOSE Brain Stem Infarction Cerebrovascular Accident Dysphagia Gait Disturbance Joint Crepitation Respiratory Failure Date:01/14/04ISR Number: 4272561-7Report Type:Expedited (15-DaCompany Report #NSADSS2003023207 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1906 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/04ISR Number: 4272623-4Report Type:Direct Company Report #CTU 210120 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dysphagia Risperdal - 2 Mg PS 1 AT NIGHT Hospitalization - Pneumonia Aspiration Initial or Prolonged Staphylococcal Infection Tardive Dyskinesia Date:01/14/04ISR Number: 4272837-3Report Type:Expedited (15-DaCompany Report #2004000757 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Incontinence Consumer Zoloft (Sertraline) PS Single Functional Kidney Remeron Trismus (Mirtazapine) SS Weight Increased Risperdal (Risperidone) SS 0.5 MG (DAILY) Depakote (Valproate Semisodium) SS Date:01/14/04ISR Number: 4273370-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031102368 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Agitation Foreign Risperdal Quicklet Other Anxiety Health (Risperidone) Fear Professional Tablets PS ORAL 1.5 MG, 1 IN Hallucination, Auditory DAY, ORAL Intentional Self-Injury Suspiciousness Thinking Abnormal Date:01/14/04ISR Number: 4273373-0Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20030802863 Age:45 YR Gender:Female I/FU:I Outcome PT Other Abdominal Distension Abnormal Sensation In Eye Anuria Arrhythmia Body Temperature Increased Cogwheel Rigidity Diarrhoea Disturbance In Attention Drug Ineffective Drug Level Increased Dry Mouth Dyskinesia Dystonia Emotional Disorder Extrapyramidal Disorder Face Oedema Fatigue Generalised Oedema Haemorrhage Hypothyroidism 22-Feb-2006 08:20 AM Page: 1907 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Influenza Keratoconjunctivitis Sicca Report Source Product Role Manufacturer Route Dose Duration Masked Facies Foreign Risperdal Musculoskeletal Stiffness Consumer (Risperidone) Oedema Peripheral Health Unspecified PS ORAL SEE IMAGE Salivary Hypersecretion Professional Oxazepam (Oxazepam) C Sensation Of Pressure Librium Strabismus (Chlordiazepoxide Syncope Hydrochloride) C Tongue Disorder Thyrax (Levothyroxine) C Date:01/14/04ISR Number: 4273379-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031105153 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypotension Foreign Risperdal Hospitalization - Health (Risperidone) Initial or Prolonged Professional Unspecified PS ORAL 1 MG, IN 1 DAY, ORAL Date:01/15/04ISR Number: 4274068-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031104108 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 4 MG, 1 IN 1 DAY, ORAL Akineton Retard (Tablets) Biperiden Hydrochloride C Stilnox (Tablets) Zolpidem C .... C Date:01/15/04ISR Number: 4274070-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040101015 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:01/15/04ISR Number: 4274072-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040101086 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Neutropenia Health (Risperidone) Professional Tablets PS ORAL 2 MG, 1 IN 1 DAY, ORAL Depakote (Valproate Semisodium) Tablets SS ORAL 750 MG, IN 1 DAY, ORAL Atenolol C 22-Feb-2006 08:20 AM Page: 1908 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hytacand (Blopress Plus) C Stablon (Tianeptine) C Seresta (Oxazepam) C Date:01/15/04ISR Number: 4274073-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040101029 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) Aspartate Professional Unspecified PS ORAL 6 MG, IN 1 Aminotransferase DAY, ORAL Increased Tercian Blood Creatine (Cyamemazine) Phosphokinase Increased Tablets SS ORAL 25 MG, 2 IN 1 Drug Interaction DAY, ORAL Hyperthermia Depakine (Valproate Sodium) C Date:01/15/04ISR Number: 4274725-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040101337 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Accident Foreign Risperdal Hospitalization - Thermal Burn Health (Risperidone) PS 6-8 MG DAILY Initial or Prolonged Professional Lofepramine Disability (Lofepramine) C Orphenadrine (Orphenadrine) C Priadel (Lithium Carbonate) C Paracetamol (Paracetamol) C Date:01/16/04ISR Number: 4273152-4Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0319832A Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intestinal Infarction Lithium PS Glaxosmithkline Hospitalization - Schizophrenia Risperidone SS INTRAMUSCULAR 50MG Every Initial or Prolonged Sepsis two weeks Chlorpromazine C Glaxosmithkline 200MG per day Ferrous Sulphate C Glaxosmithkline Acetylsalicylic Acid C Glaxosmithkline 75MG per day Date:01/16/04ISR Number: 4273724-7Report Type:Direct Company Report #CTU 210298 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pharmaceutical Product Risperidal Consta Complaint 25mg Dose Pak PS Consta 22-Feb-2006 08:20 AM Page: 1909 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/16/04ISR Number: 4276386-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031002457 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Increased Foreign Risperdal Consta Leukopenia Health (Risperidone) Professional Microsphere PS SEE IMAGE Risperdal (Risperidone) SS ORAL SEE IMAGE Ergenyl Chrono (Ergenyl Chrono) SS 2500 MG, 2 IN 1 DAY; SEE IMAGE Date:01/20/04ISR Number: 4276556-9Report Type:Expedited (15-DaCompany Report #2004001063 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Literature Geodon (Ziprasidone) PS ORAL ORAL Initial or Prolonged Electrocardiogram Health Haloperidol Abnormal Professional (Haloperidol) SS Hyperprolactinaemia Risperidone Psychotic Disorder (Risperidone) SS Tardive Dyskinesia Olanzapine Weight Increased (Olanzapine) SS Quetiapine (Quetiapine) SS Valproate (Valproic Acid) C Date:01/20/04ISR Number: 4276627-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040102666 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL ORAL Professional Date:01/20/04ISR Number: 4276628-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040102211 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS Date:01/20/04ISR Number: 4276629-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040102690 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Risperdal (Risperidone) Tablets PS ORAL ORAL Lithium (Lithium) C 22-Feb-2006 08:20 AM Page: 1910 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/20/04ISR Number: 4276704-0Report Type:Expedited (15-DaCompany Report #2004194247BR Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Celecoxib Vs Placebo Intentional Overdose Study (Code Not Broken) Health Capsule PS ORAL BID, ORAL Professional Comparator-Risperido ne (Risperidone) Tablet SS 2 MG, BID Captopril (Captopril) SS Biperiden (Biperiden) SS Levomepromazine C Zopiclone C Hydrochlorothiazide C Propranolol C Date:01/20/04ISR Number: 4276712-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040101596 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Risperdal Initial or Prolonged Atrial Tachycardia Health (Risperidone) Other Atrioventricular Block Professional Unspecified PS ORAL 1 MG, 1 IN 1 Av Dissociation DAY, ORAL; 2 Hypertension MG, 1 IN 1 Psychotic Disorder DAY, ORAL Date:01/20/04ISR Number: 4276713-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031203946 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Foreign Risperdal Syndrome Health (Risperidone) Systemic Candida Professional Unspecified PS ORAL 2 MG, IN 1 DAY, ORAL Amiodarone Hydrochloride (Amiodarone Hydrochloride) C Spironolactone (Spironolactone) C Levothyroxine Sodium (Levothyroxine Sodium) C Furosemide (Furosemide) C Date:01/20/04ISR Number: 4276714-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040101344 Age:68 YR Gender:Female I/FU:I Outcome PT Hospitalization - Bone Marrow Depression Initial or Prolonged Chills Drug Interaction Gingivitis Hyperthermia 22-Feb-2006 08:20 AM Page: 1911 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotension Oliguria Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Risperidone) Professional Tablets PS ORAL 2 MG, IN 1 DAY, ORAL Triatec (Ramipril) Tablets SS ORAL 2.5 MG, IN 1 DAY, ORAL Seropram (Citalopram Hydrobromide) SS ORAL 20 MG, IN 1 DAY, ORAL Date:01/20/04ISR Number: 4276719-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC20031005746 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Risperdal Consta Complications Of Maternal Health (Risperidone) Exposure To Therapeutic Professional Microspheres PS INTRAMUSCULAR 20 MG, Drugs INTRAMUSCULAR Maternal Drugs Affecting Depixol (Injection) Foetus Flupentixol Pregnancy Decanoate C Date:01/20/04ISR Number: 4276735-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031105153 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypotension Foreign Risperdal Hospitalization - Health (Risperidone) PS ORAL 1 MG IN 1 DAY Initial or Prolonged Professional ORAL Date:01/20/04ISR Number: 4276736-2Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040101298 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Foreign Risperdal Consta Cough Health (Risperidone) Dizziness Professional Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN Nervousness 2 WEEK, Sudden Death INTRA-MUSCULA R Akineton (Biperiden Hydrochloride) C Haldol Decanoate (Injection) (Haloperidol Deconate) C Date:01/20/04ISR Number: 4276750-7Report Type:Expedited (15-DaCompany Report #2004AP00060 Age:23 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Coma 22-Feb-2006 08:20 AM Page: 1912 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intentional Overdose Multiple Drug Overdose Oculogyration Report Source Product Role Manufacturer Route Dose Duration Suicide Attempt Foreign Atenolol PS ORAL 1400 MG DAILY Literature PO Health Oxcarbazepine SS ORAL 8700 MG DAILY Professional PO Other Risperidone SS ORAL 60 MG DAILY PO Date:01/20/04ISR Number: 4277141-5Report Type:Expedited (15-DaCompany Report #NZ-JNJFOC-20031104437 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aphagia Foreign Risperidone Hospitalization - Blood Pressure Decreased Health (Risperidone) Initial or Prolonged Cerebral Artery Occlusion Professional Solution PS 0.5 & 1 & 2 & Cerebrovascular Accident 4MG, IN 1 DAY Circulatory Collapse Antihypertensives Convulsion (Unspecified) Dialysis Antihypertensives C Dysphagia Refusal Of Treatment By Patient Renal Failure Acute Rhabdomyolysis Date:01/20/04ISR Number: 4277145-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031003844 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Neutropenia Health (Risperidone) Professional Solution PS ORAL 4 MG, 2 IN 1 DAY, ORAL Rivotril (Clonazepam) Solution C Theralene (Alimemazine Tartrate) Solution C Hept-A-Myl (Heptaminol Hydrochloride) Solution C Date:01/20/04ISR Number: 4277163-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031203445 Age:31 YR Gender:Female I/FU:I Outcome PT Other Leukocytosis Monocytosis Oedema Peripheral Pruritus Pyrexia Rash Red Blood Cell Sedimentation Rate 22-Feb-2006 08:20 AM Page: 1913 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Risperidone) Professional Tablets PS ORAL 8 MG, IN 1 DAY ORAL Depakote Valproate Semisodium C Tercian(Cyamemazine) C Date:01/21/04ISR Number: 4276455-2Report Type:Direct Company Report #CTU 210492 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Resperidol 3 Mg PS ORAL 3 MG Q PM Initial or Prolonged Convulsion ORAL Insomnia Kepra C Mobility Decreased Foltax C Oedema Felbanate C Skin Infection Synthroid C Status Epilepticus Tension Weight Increased Date:01/21/04ISR Number: 4277534-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040103161 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Date:01/21/04ISR Number: 4277540-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040102954 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:01/22/04ISR Number: 4278217-9Report Type:Direct Company Report #CTU 210676 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blister Risperidal PS 2 MGM HS Initial or Prolonged Depakote C Date:01/22/04ISR Number: 4278580-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904911 Age:70 YR Gender:Male I/FU:F Outcome PT Death Bronchospasm Hospitalization - Chronic Obstructive Initial or Prolonged Pulmonary Disease 22-Feb-2006 08:20 AM Page: 1914 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Condition Aggravated Report Source Product Role Manufacturer Route Dose Duration Health Risperdal Professional (Risperidone) Company Tablets PS ORAL 7 MG, 1 IN 1 Representative DAY, ORAL Atenolol (Atenolol) C Hydrochlorothiazide (Hydrochlorothiazide ) C Synthroid (Levothyroxine Sodium) C Diltiazem (Diltiazem) C Prednisone (Prednisone) C Z-Pac (Azithromycin) C Albuterol (Salbutamol) C Fluticasone (Fluticasone) C Date:01/22/04ISR Number: 4278586-XReport Type:Expedited (15-DaCompany Report #2004-DE-00070GD Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Literature Nevirapine(Nevirapin Distress Syndrome e) PS 400 MG Coma Nefazodone Confusional State (Nefazodone) SS Drug Interaction Ritonavir Drug Toxicity (Ritonavir) SS 600 MG Encephalopathy Saquinavir Epilepsy (Saquinavir) SS 1200 MG Grand Mal Convulsion Lamotrigine Hand Fracture (Lamotrigine) SS DOSE Hepatic Failure ESACLATION UP Hepatic Steatosis TO 1800 Hepatotoxicity MG/DAY Liver Function Test Phenytoin Abnormal (Phenytoin) SS RT Multi-Organ Failure Ris[Peridone Osteopenia (Risperidone) SS 2 MG Psychotic Disorder Quetiapine Sudden Death (Quetiapine) SS Tibia Fracture Sertraline (Sertraline) C Lorazepam (Lorazepam) C Gabapentin (Gabapentin) C 22-Feb-2006 08:20 AM Page: 1915 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/04ISR Number: 4279340-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031105447 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extradural Haematoma Foreign Risperdal Initial or Prolonged Fall Health (Risperidone) PS ORAL 8 MGM IN 1 Hallucination Professional DAY, ORAL Hand Fracture Zyprexa (Olanzapine) C Joint Dislocation Medication Error Radius Fracture Wrist Fracture Date:01/23/04ISR Number: 4279526-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040103672 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperidone Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:01/23/04ISR Number: 4279531-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040103769 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:01/23/04ISR Number: 4279645-8Report Type:Expedited (15-DaCompany Report #S04-FRA-00132-01 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Foreign Seropram (Citalopram Initial or Prolonged Blood Sodium Decreased Health Hydrobromide) PS ORAL 20 MG QD PO Chills Professional Triatec (Ramipril) SS ORAL 2.5 MG QD PO Gingivitis Other Risperdal Haemoglobin Decreased (Risperidone) SS ORAL 2 MG QD PO Hyperthermia Hypotension Oliguria Platelet Count Increased Date:01/23/04ISR Number: 4279704-XReport Type:Expedited (15-DaCompany Report #DEWYE425726NOV03 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Trevilor Initial or Prolonged Increased Study (Venlafaxine Drug Interaction Health Hydrochloride) PS ORAL SEE IMAGE 2 DAY Gamma-Glutamyltransferase Professional Beloc Zok Increased Other (Metoprolol Hepatic Enzyme Increased Succinate, 0) SS ORAL SEE IMAGE Remergil (Mirtazapine, 0) SS ORAL SEE IMAGE 14 DAY Risperdal (Risperidone) SS ORAL 2MG Tavor (Lorazepam) SS ORAL SEE IMAGE 53 DAY 22-Feb-2006 08:20 AM Page: 1916 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Quilonum - Slow Release (Lithium Carbonate) C Chloraldurat (Chloral Hydrate) C Date:01/23/04ISR Number: 4279708-7Report Type:Expedited (15-DaCompany Report #DEWYE499408JAN04 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Tavor (Lorazepam, Initial or Prolonged Hepatic Enzyme Increased Study Unspec) PS ORAL SEE IMAGE 13 DAY Health Beloc Zok Professional (Metoprolol Other Succinate) SS ORAL SEE IMAGE 6 DAY Remergil (Mirtazapine) SS ORAL SEE IMAGE 14 DAY Risperdal (Risperidone) SS ORAL 2 MG 1 X PER 1 DAY Trevilor (Venlafaxine Hydrochloride) SS ORAL SEE IMAGE 12 DAY Quilonum - Slow Release (Lithium Carbonate) C Chloraldurat (Chloral Hydrate) C Date:01/23/04ISR Number: 4280353-8Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20040102584 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Acute Foreign Risperdal Initial or Prolonged Rhabdomyolysis Health (Risperidone) Professional Tablets PS ORAL 3 MG, IN 1 DAY, ORAL Valdorm (Flurazepam Hydrocloride) C Date:01/23/04ISR Number: 4280354-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040101015 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Risperidone) Professional Tablets PS ORAL 3 MG, IN 1 DAY, ORAL Lorazepam (Lorazepam) C Date:01/23/04ISR Number: 4280357-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031201566 Age:36 YR Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 1917 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Foreign Risperidal Blood Creatine Health (Risperidone) PS ORAL SEE IMAGE Phosphokinase Increased Professional Paroxetine Disease Recurrence Hydrochloride Gait Disturbance Hydrate (Paroxetine) SS ORAL SEE IMAGE Irritability Flunitrazepam Myoclonus (Flunitrazepam) C Obsessive-Compulsive Vegetamin-B Disorder (Vegetamin A) Serotonin Syndrome Tablets C Urinary Incontinence Biperiden Hydrochloride (Biperiden Hydrochloride) C Cold Medicine (Cold Capsules) Tablets C Diazepam (Diazepam) C Lactated Ringer'S Solution (Ringer "Merck") Solution C Date:01/23/04ISR Number: 4280364-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040103409 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Risperdal Neuroleptic Malignant Health (Risperidone) PS ORAL 4 MG, IN 1 Syndrome Professional DAY, ORAL Tracheal Obstruction Tiapride Hydrochloride (Tiapride Hydrochloride) C Prazosin Hydrochloride (Prazosin Hydrochloride) C Chlormadinone Acetate (Chlormadinone Acetate) C Date:01/26/04ISR Number: 4279916-5Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040103669 Age:18 YR Gender:Male I/FU:I Outcome PT Other Abnormal Behaviour Condition Aggravated Dyskinesia Euphoric Mood Faecal Incontinence Hallucination Mental Disorder Obsessive Thoughts Salivary Hypersecretion Social Avoidant Behaviour Speech Disorder 22-Feb-2006 08:20 AM Page: 1918 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Vomiting Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Consumer (Risperidone) Unspecified PS 2 MG, IN 1 DAY Seroquel (Quetiapine Fumarate) C Lithium (Lithium) C Efexor (Venlafaxine Hydrochloride) C Date:01/26/04ISR Number: 4280116-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031100012 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Reaction Foreign Risperdal Excitability Health (Risperidone) Gait Disturbance Professional Unspecified PS ORAL SEE IMAGE Glaucoma Cyclosporin Incontinence (Ciclosporin) C Vision Blurred Penicillin (Benzylpenicillin Sodium) C Septrin (Bactrim) C Prednisolone (Prednisolone) C Fluconazole (Fluconazole) C Alphagan (Brimonidine Tartrate) C Trusopt (Dorzolamide Hydrochloride) C Date:01/26/04ISR Number: 4280118-7Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040103948 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Foreign Risperdal Medication Error Consumer (Risperidone) Somnolence Unspecified PS 25 MG, IN 2 TOTAL Date:01/26/04ISR Number: 4280135-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031104044 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Health Risperdal Professional (Risperidone) Unspecified PS 22-Feb-2006 08:20 AM Page: 1919 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/04ISR Number: 4280140-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040103732 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Risperdal Professional (Risperidone) Unspecified PS Date:01/26/04ISR Number: 4280141-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040103679 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Risperdal Congestive Health (Risperidone) Professional Tablets PS ORAL , 1 IN 1 DAY, ORAL Date:01/26/04ISR Number: 4280146-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040103724 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Date:01/26/04ISR Number: 4280439-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040104151 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Septic Shock Consumer Risperdal (Risperidone) Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Duragesic (Fentanyl) Unspecified C Demerol (Pethidine Hydrochloride) C Vasotec (Enalapril Maleate) C Lasix (Furosemide) C K-Dur (Potassium Chloride) C Iron (Iron) C Keflex (Cefalexin Monohydrate) C Diflucan (Fluconazole) C Date:01/27/04ISR Number: 4279375-2Report Type:Expedited (15-DaCompany Report #WAES 0307DEU00072 Age:81 YR Gender:Male I/FU:F Outcome PT Death Death Life-Threatening Dialysis Hospitalization - Drug Interaction Initial or Prolonged Duodenal Ulcer Haemorrhage 22-Feb-2006 08:20 AM Page: 1920 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Failure Report Source Product Role Manufacturer Route Dose Duration Health Vioxx PS Merck & Co., Inc ORAL Professional Vasotec SS ORAL Esomeprazole Magnesium SS ORAL Furosemide Sodium SS ORAL Vioxx SS Merck & Co., Inc ORAL Olanzapine SS ORAL Risperidone SS ORAL Date:01/27/04ISR Number: 4280502-1Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20040102891 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal Hospitalization - Cheyne-Stokes Respiration Health (Risperidone) Initial or Prolonged Depressed Level Of Professional Unspecified PS ORAL 0.5 MG, 2 IN Consciousness 1 DAY ORAL Pulmonary Oedema Insulatard (Insulin Shock Human Injection, Isophane) C Prednisolon (Prednisolone) C Capoten (Captopril) C Sandimmun (Ciclosporin) C Trombyl (Acetylsalicylic Acid) C Date:01/27/04ISR Number: 4280504-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040103749 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Dyskinesia Health (Risperidone) Professional Unspecified PS ORAL ORAL Fluanxol Depot (Flupentixol Decanoate) C Date:01/27/04ISR Number: 4280619-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040103253 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Topamax (Topiramate) Initial or Prolonged Increased Professional Unspecified PS 150 MG, 2 IN Aspartate 1 DAY Aminotransferase Risperdal Increased (Rispridone) Condition Aggravated Unspecified SS ORAL 1 MG, 2 IN 1 Convulsion DAY, ORAL Haematocrit Decreased Keppra Haemoglobin Decreased (Levetiracetam) C Hepatomegaly Ativan (Lorazepam) C Splenomegaly Tylenol 22-Feb-2006 08:20 AM Page: 1921 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Paracetamol) C Phenobarbital (Phenobarbital) C Date:01/27/04ISR Number: 4280657-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040103565 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Platelet Count Decreased (Risperidone) Red Blood Cell Unspecified PS ORAL 3 MG, IN 1 Sedimentation Rate DAY, ORAL Increased Dytide H (Dyazide) White Blood Cell Count Tablets SS ORAL ORAL Decreased Bayotensin (Nitrendipine) SS Date:01/27/04ISR Number: 4280658-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040101302 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Risperdal Hospitalization - Blood Creatinine Health (Risperidone) Initial or Prolonged Increased Professional Unspecified PS ORAL 2 MG, IN 1 Other Cerebrovascular Accident DAY, ORAL Convulsion Aldactone Gastrointestinal (Spironolactone) C Haemorrhage Lasilix (Furosemide) C White Blood Cell Count Seresta (0xazepam) C Increased Hyperium (Rilmenidne) C Laroxyl (Amitriptyline Hydrochloride) Soluton C Doliprane (Paracetamol) C Duphalac (Lactulose) C Fonzylane (Buflomedil Hydrochloride) C Calcidia (Calcium Carbonate) C Date:01/27/04ISR Number: 4280659-2Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20030802863 Age:45 YR Gender:Female I/FU:F Outcome PT Other Abnormal Sensation In Eye Arrhythmia Diarrhoea Disturbance In Attention Drug Effect Decreased Drug Level Increased Dry Mouth Dyskinesia Emotional Disorder Extrapyramidal Disorder Face Oedema 22-Feb-2006 08:20 AM Page: 1922 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Feeling Abnormal Generalised Oedema Headache Report Source Product Role Manufacturer Route Dose Duration Influenza Foreign Risperdal Keratoconjunctivitis Consumer (Risperidone) Sicca Health Unspecified PS ORAL 4 MG, IN 1 Masked Facies Professional DAY, ORAL; Stress 3MG, IN 1 Tongue Disorder DAY, ORAL Urinary Incontinence Oxazepam (Oxazepam) Tablets C Librium (Chlordiazepoxide Hydrochloride) C Thyrax (Levothyroxine) C Date:01/27/04ISR Number: 4280847-5Report Type:Expedited (15-DaCompany Report #HQWYE480620JAN04 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Efexor (Venlafaxine Anger Hydrochloride, Elevated Mood Tablet) PS ORAL 150 MG 1X PER Homicidal Ideation 1 DAY Legal Problem Risperdal (Risperidone, ) SS ORAL SEE IMAGE Zoloft (Sertraline Hydrochloride) SS 100 MG IN THE MORNING AND 50 MG MID-DAY Date:01/27/04ISR Number: 4280994-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040103253 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Topamax (Topiramate) Initial or Prolonged Increased Professional Unspecified PS 150 MG, 2 IN Aspartate 1 DAY, Aminotransferase Risperdal Increased (Risperidone) Convulsion Unspecified SS ORAL 1 MG, 2 IN 1 Haematocrit Decreased DAY, ORAL Haemoglobin Decreased Keppra Hepatomegaly (Levetiracetam) Splenomegaly Unspecified C Ativan (Lorazepam) Unspecified C Tylenol(Paracetamol) Unspecified C Phenobarbital (Phenobarbital) C 22-Feb-2006 08:20 AM Page: 1923 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/27/04ISR Number: 4280999-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040104212 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:01/27/04ISR Number: 4281004-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040104113 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:01/27/04ISR Number: 4281006-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040104197 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Risperdal (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Date:01/28/04ISR Number: 4280474-XReport Type:Direct Company Report #CTU 210950 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS ORAL 6 MG DAILY PO Date:01/29/04ISR Number: 4280913-4Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0319907A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Seroxat PS Glaxosmithkline Extrapyramidal Disorder Professional Risperidone SS Date:01/29/04ISR Number: 4282532-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030905351 Age:93 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anaemia Initial or Prolonged Back Injury Contusion Dehydration Diabetes Mellitus Dysphagia Dyspnoea Electrocardiogram Abnormal Fall Gastritis Hypernatraemia Oral Intake Reduced Pain Renal Failure 22-Feb-2006 08:20 AM Page: 1924 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Failure Acute Urosepsis Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 0.25 MG, 2 IN 1 DAY, ORAL Lotensin (Benazepril Hydrochloride) C Vioxx (Rofecoxib) C Adalat (Nifedipine) C Exelon (Rivastigmine Tartrate) C Senna (Senna) C Date:01/29/04ISR Number: 4283224-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040103569 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Risperdal Initial or Prolonged Neuroleptic Malignant Health (Risperidone) PS ORAL SEE IMAGE Syndrome Professional Company Representative Date:01/29/04ISR Number: 4283225-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040103541 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Risperidone) PS ORAL 12 MG, IN 1 Professional DAY, ORAL Zopiclone (Zopiclone) C Date:01/29/04ISR Number: 4283226-XReport Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040104744 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Foreign Risperdal Health (Risperidone) PS Professional Date:01/29/04ISR Number: 4283227-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040103424 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Disorder Foreign Risperdal Food Allergy Health (Risperidone) PS ORAL ORAL Grunting Professional Dexamfetamine Tongue Oedema (Dexamfetamine) C Melatonin (Melatonin) C 22-Feb-2006 08:20 AM Page: 1925 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/29/04ISR Number: 4283228-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040104056 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperdal Initial or Prolonged Feeling Abnormal Health (Risperidone) PS ORAL 3 MG, IN 1 Disability Mental Disorder Professional DAY, ORAL Date:01/29/04ISR Number: 4283229-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040103625 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Risperdal Initial or Prolonged Chest Pain Health (Risperidone) PS ORAL 1 MG, IN 1 Electrocardiogram Qt Professional DAY, ORAL Prolonged Corvasal Fall (Molsidomine) C Hand Fracture Temesta (Lorazepam) C Malaise Fraxiparine Myocardial Infarction (Heparin-Fraction), Myoglobin Blood Increased Calcium Salt C Sinus Tachycardia Seropram (Citalopram Hydrobromide) C Cardensiel (Nicardipine Hydrochloride) C Risordan (Isosorbide Dinitrate) C Kardegic (Acetylsalicylic Lysine) C Date:01/29/04ISR Number: 4283230-1Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20040103758 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Increased Foreign Risperdal Consta Initial or Prolonged Dyspnoea Health (Risperidone) Fatigue Professional Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN 14 DAY, INTRA-MUSCULA R Furosemide (Tablets) Furosemide C Acetylsalicylic Acid (Tablets) Acetylsalicylic Acid C Digitoxine (Digitoxin) Tablets C Kaleorid (Potassium Chloride) Tablets C Date:01/29/04ISR Number: 4283237-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040103756 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Neutropenia Health (Risperidone) Professional Tablets PS ORAL 4 MG, IN 1 22-Feb-2006 08:20 AM Page: 1926 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY, ORAL Zyprexa (Olanzapine) SS Date:01/29/04ISR Number: 4283238-6Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20040102891 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal Hospitalization - Cheyne-Stokes Respiration Health (Risperidone) Initial or Prolonged Depressed Level Of Professional Unspecified PS ORAL 0.5 MG, 2 IN Consciousness 1 DAY, ORAL; Pulmonary Oedema 0.5 MG, IN 1 Shock DAY, ORAL Insulatard (Insulin Human Injection, Isophane) C Prednisolon (Prednisolone) C Capoten (Captopril) C Sandimmun (Ciclosporin) C Trombyl (Acetylsalicylic Acid) C Date:01/29/04ISR Number: 4283239-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040103131 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cogwheel Rigidity Foreign Risperdal Initial or Prolonged Glaucoma Health (Risperidone) Tremor Professional Tablets PS ORAL 1 MG, IN 1 Company DAY, ORAL Representative Date:01/29/04ISR Number: 4283289-1Report Type:Expedited (15-DaCompany Report #K200400074 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Foreign Kemadrin Oculogyration Health (Procyclidine) Vomiting Professional Tabket , 5 Mg PS SEE IMAGE Other Risperidone (Risperidone) SS Date:01/30/04ISR Number: 4282634-0Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12151098 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Abnormal Dreams Serzone Tabs 300 Mg PS Bristol-Myers Squibb Nervousness Company ORAL Sleep Disorder Risperidone SS ORAL exact date of start date is unclear-eithe r 06-Sep-02 or 06-Oct-02 22-Feb-2006 08:20 AM Page: 1927 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/04ISR Number: 4283384-7Report Type:Direct Company Report #USP 56279 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Fatigue Biperiden PS TABLET Medication Error Resperidone SS Janssen TABLET Somnolence Date:01/30/04ISR Number: 4284682-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040101596 Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Tachycardia Foreign Risperdal Initial or Prolonged Atrioventricular Block Health (Risperidone) Other Av Dissociation Professional Unspecified PS ORAL SEE IMAGE Bundle Branch Block Left Vioxx (Rofecoxib Condition Aggravated Tablets C Hypertension Enahexal (Enalapril Psychotic Disorder Maleate) Tablets C Zolpidem (Zolpidem) C Paracetamol (Paracetamol) Tablets C Neygeron (Neygeront- Capsule) Capsules C Esldrix (Hydrochlorothiazide ) Tablets C Date:01/30/04ISR Number: 4284684-7Report Type:Expedited (15-DaCompany Report #IN-JNJFOC-20040103396 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Duodenal Ulcer Foreign Risperidone - Initial or Prolonged Microcytic Anaemia Study Blinded Other Health (Risperidone) Professional Tablets PS ORAL 2 DOSE (S), 2 IN 1 DAY, ORAL Quetiapine (Quetiapine) Capsules SS ORAL 2 DOSE (S), 2 IN 1 DAY, ORAL Placebo (Placebo) Capsules SS ORAL 2 DOSE (S), 2 IN 1 DAY, ORAL Date:01/30/04ISR Number: 4284798-1Report Type:Direct Company Report #CTU 211241 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Risperidone PS Transient Ischaemic Attack 22-Feb-2006 08:20 AM Page: 1928 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/04ISR Number: 4284778-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040104990 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspepsia Foreign Risperidone Initial or Prolonged Gastric Disorder Health (Risperidone) Muscle Hypertrophy Professional Unspecified PS ORAL 2 MG, IN 1 Regurgitation Of Food DAY, ORAL Haloperidol (Haloperidol) C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Mosapride Citrate (Mosapride Citrate) C Date:02/02/04ISR Number: 4284779-8Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040104974 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antiphospholipid Foreign Risperdal Antibodies Positive Health (Risperidone) Drug Interaction Professional Unspecified PS Protein Total Decreased Mirtazapine (Mirtazapine) Unspecified SS Date:02/02/04ISR Number: 4284782-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031201566 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Risperdal Initial or Prolonged Blood Creatine Health (Risperidone) PS ORAL SEE IMAGE Other Phosphokinase Increased Professional Paroxetine Condition Aggravated Hydrochloride Dizziness Hydrate (Paroxetine) SS ORAL SEE IMAGE Drug Ineffective Flunitrazepam Gait Disturbance (Flunitrazepam) C Hypoaesthesia Vegetamin - B Irritability (Vegetamin A) C Malaise Biperiden Obsessive-Compulsive Hydrochloride Disorder (Biperiden Pharyngolaryngeal Pain Hydrochloride) C Salivary Hypersecretion Cold Medicine (Cold Serotonin Syndrome Capsules) C Upper Respiratory Tract Diazepam (Diazepam) C Infection Lactated Ringer'S Urinary Incontinence Solution (Ringer "Merck") C 22-Feb-2006 08:20 AM Page: 1929 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/04ISR Number: 4284946-3Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20040105890 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Consta Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR INTRA-MUSCULA R Clozaril (Clozapine) C Date:02/02/04ISR Number: 4284947-5Report Type:Expedited (15-DaCompany Report #EMADSS2001000865 Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrooesophageal Reflux Foreign Risperdal Disease Health (Risperidone) Oral Intake Reduced Professional Tablets PS ORAL 1.5 MG, ORAL Respiratory Disorder Durogesic (Fentanyl) Toxic Epidermal Patch SS TRANSDERMAL 25 UG, Necrolysis TRANSDERMAL Heminevrin (Clomethiazole Edisilate) Capsules SS 300 MG Propavan (Propiomazine Maleate) Tablets SS ORAL 25 MG, ORAL Mycostatin (Nystatin) Suspension SS ORAL 4 ML, ORAL Plavix (Clopidogrel Sulfate) Tablets SS ORAL 75 MG, ORAL Lanzo (Lansoprazole) Capsules SS ORAL 30 MG, ORAL Imovane (Zopiclone) Tablets C Erco-Fer (Ferrous Fumarate) Tablets C Theo (Theophylline) Tablets C Spironolakton (Spironolactone) C Duphalac (Lactulose) Solution C Date:02/02/04ISR Number: 4285576-XReport Type:Expedited (15-DaCompany Report #NSADSS2003021743 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Risperdal Cerebrovascular Accident (Risperidone) Fall Tablets PS ORAL SEE IMAGE Injury Aspirin Lacunar Infarction (Acetylsalicylic Orthostatic Hypotension Acid) C Palpitations Diltiazem Pneumonia (Diltiazem) C Skin Laceration Aricept (Donepezil Therapeutic Agent Hydrochloride) C Toxicity Urinary Tract Infection 22-Feb-2006 08:20 AM Page: 1930 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/04ISR Number: 4285577-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040100268 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL 3 MG, 1 IN 1 DAY, ORAL Glucotrol (Glipizide) C Glucophage (Metformin Hydrochloride) C Zestril (Lisinopril) C Synthroid (Levothyroxine Sodium) C Celexa (Citalopram Hydrobromide) C Tricor (Fenofibrate) C Date:02/02/04ISR Number: 4285595-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031005043 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 2 MG, 3 IN 1 DAY, ORAL Ativan (Lorazepam) C Cogentin (Benzatropine Mesilate) C Date:02/02/04ISR Number: 4285597-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040104129 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Risperdal Insulin-Dependent (Risperidone) Tablets PS ON IT LESS THAN 1 YEAR Buspar (Buspirone Hydrochloride) C Paxil (Paroxetine Hydrochloride) C Date:02/03/04ISR Number: 4284148-0Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0312701A Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Restless Legs Syndrome Deroxat PS Glaxosmithkline ORAL 40MG Per day Initial or Prolonged Restlessness Risperdal SS ORAL Anxiolytic C UNKNOWN Sedative(Unknown) C UNKNOWN 22-Feb-2006 08:20 AM Page: 1931 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/04ISR Number: 4285638-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040104839 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Tablets PS ORAL 1.5 MG, 3 IN 1 DAY, ORAL Reminyl (Galantamine) Unspecified SS Date:02/03/04ISR Number: 4285652-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040106029 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Foreign Risperdal Consta Initial or Prolonged Study (Risperidone) Health Microspheres PS INTRAMUSCULAR SEE IMAGE Professional Metoprolol (Metoprolol) C Fluvoxamin (Fluvoxamine) C Date:02/03/04ISR Number: 4285657-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040103569 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Risperdal Initial or Prolonged Neuroleptic Malignant Health (Risperidone) Syndrome Professional Unspecified PS ORAL 2 MG, 1 IN 1 Company DAY, ORAL Representative Date:02/03/04ISR Number: 4285860-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040104719 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Foreign Risperdal Initial or Prolonged Syncope Health (Risperidone) PS ORAL 1 MG, 1 IN 1 Professional DAY, ORAL Date:02/03/04ISR Number: 4285861-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031104108 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Malnutrition Health (Risperidone) PS ORAL 4 MG, 1 IN 1 Professional DAY, ORAL Akineton Retard (Biperiden Hydrochloride) Tablets C Stilnox (Zolpidem) C 22-Feb-2006 08:20 AM Page: 1932 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/04ISR Number: 4285873-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031102370 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dialysis Foreign Risperdal Hospitalization - Lower Respiratory Tract Health (Risperidone) Initial or Prolonged Infection Professional Unspecified PS ORAL 6 MG, IN 1 Renal Failure Acute DAY, ORAL Depakote (Valproate Semisodium) SS 500 MG, 3 IN 1 DAY Date:02/03/04ISR Number: 4286016-7Report Type:Expedited (15-DaCompany Report #2004AP00060 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Atenolol PS ORAL 1400 MG DAILY Initial or Prolonged Coma Literature PO Drug Interaction Health Risperidone SS ORAL 60 MG DAILY Intentional Overdose Professional PO Oculogyration Other Oxcarbazepine SS ORAL 8700 MG DAILY Suicide Attempt PO Date:02/04/04ISR Number: 4286536-5Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20040105085 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Foreign Risperdal Decreased Health (Risperidone) Bruxism Professional Unspecified PS SEE IMAGE Date:02/04/04ISR Number: 4286646-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031003238 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Health Risperdal Blood Chloride Increased Professional (Risperidone) Blood Sodium Increased Tablets PS ORAL 0.75 MG, 1 IN Coma 1 DAY, ORAL; Diabetes Mellitus 0.25 MG, 1 IN Hypotension 1 AS Pco2 Increased NECESSARY, Pneumonia Aricept (Donepezil Po2 Decreased Hydrochloride) C Renal Failure Synthroid Troponin T Increased (Levothyroxine Urinary Tract Infection Sodium) C Paxil (Paroxetine Hydrochloride) C Prednisone (Prednisone) C Roxanol (Morphine Sulfate) C 22-Feb-2006 08:20 AM Page: 1933 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/04ISR Number: 4286647-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040105154 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Risperdal Professional (Risperidone) Company Tablets PS ORAL 3 MG, 1 IN 1 Representative DAY, ORAL Date:02/04/04ISR Number: 4286648-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040101515 Age:93 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal Fall Professional (Risperidone) Hip Fracture Unspecified PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Date:02/04/04ISR Number: 4286804-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040101527 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Risperdal Consta Professional (Risperidone) Microspheres PS 25 MG, INJECTION Ativan (Lorazepam) C Risperdal (Risperidone) Unspecified C Date:02/04/04ISR Number: 4286806-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040105146 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Shock Health Risperdal Initial or Prolonged Professional (Risperidone) Tablets PS DOSE UNSPECIFIED Date:02/04/04ISR Number: 4286809-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040105486 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Health Risperdal Polycythaemia Professional (Risperidone) Unspecified PS ORAL 8 MG, IN 1 DAY, ORAL Clozapine (Clozapine) Tablets SS ORAL 400 MG, 1 IN 1 DAY, ORAL Effexor (Venlafaxine Hydrochloride) SS 150 MG, 1 IN 1 DAY Benadryl (Diphenhydramine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1934 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/04ISR Number: 4287446-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040105999 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS Date:02/05/04ISR Number: 4287448-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040200164 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Health Risperdal Congestive Professional (Risperidone) Tablets PS ORAL 0.25 MG, 1 IN 1 DAY, ORAL Date:02/05/04ISR Number: 4288475-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040105714 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL 2.5 MG, 1 IN 1 DAY, ORAL Date:02/05/04ISR Number: 4288646-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040105041 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Foreign Risperidone Hospitalization - Pulmonary Embolism Health (Risperidone) PS ORAL 2 IN 1 DAY, Initial or Prolonged Professional ORAL Minocycline (Minocycline) C Hydrocortisone (Hydrocortisone) C Date:02/05/04ISR Number: 4288649-0Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040103948 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Foreign Risperdal Overdose Consumer (Risperidone) PS 25 MG, IN 2 Somnolence Health TOTAL Professional Date:02/05/04ISR Number: 4288707-0Report Type:Expedited (15-DaCompany Report #2003-110405-NL Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Health Mirtazapine PS ORAL 15 MG/45 MG, Increased Professional ORAL 2 WK Drug Interaction Venlafaxine Potentiation Hydrochloride SS ORAL 37.5 MG, Gamma-Glutamyltransferase ORAL;75 Increased MG;150 Hepatic Enzyme Increased MG;187.5 22-Feb-2006 08:20 AM Page: 1935 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report MG;225 MG; 12 DAY Lorazepam SS ORAL 1.5 MG, ORAL;3 MG; 2 MG; 1.5 MG; 1 MG; 0.5 MG 11 DAY Metoprolol Succinate SS ORAL 47.5 MG/95 MG, ORAL 6 DAY Risperidone SS ORAL 2 MG, ORAL Chloral Hydrate C Date:02/05/04ISR Number: 4288762-8Report Type:Expedited (15-DaCompany Report #DEWYE542629JAN04 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Health Trevilor Initial or Prolonged Bowel Sounds Abnormal Professional (Venlafaxine Circulatory Collapse Hydrochloride, Convulsion Tablet, 0) PS ORAL 2-3 TABLETS Intentional Overdose ORAL 1 DAY Multiple Drug Overdose Alcohol (Ethanol, , Tachycardia 0) SS ORAL ORAL 1 DAY Insidon (Opipramol Hydrochloride , , 0) SS ORAL 2-3 TABLETS 1 DAY Juvental (Atenolol, , 0) SS ORAL ORAL 1 DAY Oxazepam (Oxazepam, , 0) SS 10 TABLETS (OVERDOSE AMOUNT 100 MG) 1 DAY Risperdal (Risperidone, , 0) SS ORAL 2-3 TABLETS 1 DAY Date:02/06/04ISR Number: 4286737-6Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0313068A Age:92 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Deroxat PS Glaxosmithkline ORAL Drug Interaction Professional Risperdal SS ORAL Somnolence Date:02/06/04ISR Number: 4288964-0Report Type:Expedited (15-DaCompany Report #S03-USA-03512-01 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Health Lexapro Convulsion Professional (Escitalopram) PS ORAL 10 MG QD PO Electroencephalogram Company Lexapro Abnormal Representative (Escitalopram) SS ORAL 10 MG QD PO Epilepsy Lexapro Haematocrit Decreased (Escitalopram) SS ORAL 5 MG QD PO Headache Risperdal Loss Of Consciousness (Risperidone) SS 1 MG TID Risperdal (Risperidone) SS 1 MG BID Trileptal (Oxcarbazepine) SS 300 MG QAM Trileptal (Oxcarbazepine) SS 6 00 MG QHS 22-Feb-2006 08:20 AM Page: 1936 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/04ISR Number: 4289010-5Report Type:Expedited (15-DaCompany Report #NSADSS2002037230 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypovolaemia Consumer Risperdal Pneumonia Health (Risperidone) PS ORAL ORAL Urinary Tract Infection Professional Date:02/06/04ISR Number: 4289140-8Report Type:Expedited (15-DaCompany Report #EMADSS2003004284 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - General Nutrition Foreign Risperdal Initial or Prolonged Disorder Health (Risperidone) Other Hepatic Cirrhosis Professional Unspecified PS ORAL 4 MG, ORAL Hepatic Fibrosis Lyogen Hepatic Steatosis (Fluphenazine) Treatment Noncompliance Injection C Cipramil (Citalopram Hydrobromide) C Date:02/06/04ISR Number: 4289242-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040200315 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Consta Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR 25 MG, Representative INTRAMUSCULAR Risperdal (Risperidone) Tablets SS Date:02/06/04ISR Number: 4289352-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040200004 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Enterocolitis Foreign Risperdal Initial or Prolonged Extrapyramidal Disorder Health (Risperidone) Ileus Paralytic Professional Unspecified PS ORAL 4 MG, IN 1 DAY, ORAL Dai-Kenchu-To (All Other Therapeutic Products) C Magnesium Oxide (Magnesium Oxide) C Lorazepam (Lorazepam) C Pantethine (Patethine) C Antidiarrheals, Intestinal Regulators (All Other Therapeutic Products) C Mosapride Citrate (Mosapride Citrate) C Dimeticone (Dimeticone) C 22-Feb-2006 08:20 AM Page: 1937 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Distigmine Bromide (Distigmine Bromide) C Piperacillin Sodium (Piperacillin Sodium) C Date:02/06/04ISR Number: 4289359-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030901361 Age:93 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Health Risperdal Disease Progression Professional (Risperidone) Transient Ischaemic Tablets PS ORAL 0.5 MG, 2 IN Attack 1 DAY, ORAL Urinary Tract Infection Haldol (Haloperidol) C Atenolol (Atenolol) C Date:02/06/04ISR Number: 4289380-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040105291 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Date:02/09/04ISR Number: 4290545-XReport Type:Expedited (15-DaCompany Report #USA-2004-0012400 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Ms Contin Tablets Initial or Prolonged Hallucination, Visual Professional (Morphine Sulfate) Medication Error Cr Tablet PS 200 MG, Q4TH, Skin Laceration UNK Risperdal (Risperidone) SS Elavil (Amitriptyline Hydrochloride) C Klonopin (Clonazepam) C Effexor (Venlafaxine Hydrochloride) C Ativan (Lorazepam) C Potassium (Potassium) C Glucophage (Metformin Hydrchloride) C Insulin, Regular (Insulin) C Glipizide (Glipizide) C 22-Feb-2006 08:20 AM Page: 1938 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/04ISR Number: 4290728-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031203560 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Risperdal Initial or Prolonged Exposure To Therapeutic Health (Risperidone) Drugs Professional Tablets PS ORAL 1 MG, 2 IN 1 Escherichia Sepsis Company DAY, ORAL Hypothermia Representative Clamoxyl Urinary Tract Infection (Amoxicillin Trihydrate) C Date:02/10/04ISR Number: 4293356-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040200226 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Health Risperdal Failure To Thrive Professional (Risperidone) PS Date:02/10/04ISR Number: 4293361-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040200228 Age:94 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 1 MG, IN 1 DAY, ORAL Date:02/10/04ISR Number: 4293610-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040200180 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Foreign Risperdal Life-Threatening Cerebrovascular Accident Health (Risperidone) PS ORAL 1 MG, 5 IN 1 Hospitalization - Dysphagia Professional AS NECESSARY, Initial or Prolonged Loss Of Consciousness ORAL Disability Somnolence Prednisolone (Prednisolone) C Diazepam (Diazepam) C Nifedipine (Nifedipine) C Alendronic Acid (Alendronic Acid) C Cimetidine (Cimetidine) C Zoldpidem (Zolpidem) C Aspirin (Acetylsalicylic Acid) C Date:02/10/04ISR Number: 4293624-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031203551 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erectile Dysfunction Foreign Risperdal Hepatic Cirrhosis Health (Risperidone) PS ORAL 4 MG, IN 1 Hepatic Steatosis Professional DAY, ORAL Weight Increased 22-Feb-2006 08:20 AM Page: 1939 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/10/04ISR Number: 4293626-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040103541 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Neutropenia Health (Risperidone) Professional Tablets PS ORAL SEE IMAGE Procyclidine (Procyclidine) C Zopiclone (Zopiclone) C Date:02/10/04ISR Number: 4293628-3Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040104001 Age:54 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Risperdal Sudden Death Health (Risperidone) PS 2 MG, 1 IN 1 Professional DAY Company Fluvoxamine Representative (Fluvoxamine) C Glibenclamide ( Glibenclamide)Tablet s C Lisinopril (Lisinopril) Tablets C Date:02/10/04ISR Number: 4293630-1Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20040200044 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hiccups Foreign Risperdal Initial or Prolonged Health (Risperidone)Unspeci Professional fied PS ORAL 6 MG, IN 1 DAY, ORAL Date:02/11/04ISR Number: 4291043-XReport Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0432287A Age: YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Epistaxis Paxil PS Glaxosmithkline Risperdal SS Date:02/11/04ISR Number: 4292251-4Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0313068A Age:92 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Deroxat PS Glaxosmithkline ORAL Drug Interaction Professional Risperdal SS ORAL Somnolence Date:02/11/04ISR Number: 4293372-2Report Type:Direct Company Report #CTU 212014 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Grand Mal Convulsion Risperodol 1 Mg Tab PS 1 DAY 2 Other NIGHTLY 22-Feb-2006 08:20 AM Page: 1940 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Crixivan C Zerit C Epivir C Meclizine C Date:02/11/04ISR Number: 4293801-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031104673 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activities Of Daily Consumer Risperdal Living Impaired (Risperdal) Tablets PS ORAL ORAL Alopecia Haldol (Haloperidol) Amnesia Unspecified SS Diplopia Cogentin Drooling (Benzatropine Eyelid Ptosis Mesilate) SS Gastrointestinal Disorder Muscle Atrophy Overdose Posture Abnormal Suicide Attempt Tardive Dyskinesia Vision Blurred Date:02/11/04ISR Number: 4294219-0Report Type:Expedited (15-DaCompany Report #NSADSS2002009796 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Contusion Consumer Risperdal Full Blood Count Health (Risperidone) Decreased Professional Tablets PS ORAL SEE IMAGE Platelet Count Decreased Synthroid (Levothyroxine Sodium) C Restoril (Temazepam) C Date:02/11/04ISR Number: 4294220-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040200905 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 3 MG, ORAL Date:02/11/04ISR Number: 4294452-8Report Type:Expedited (15-DaCompany Report #200410005BNE Age:86 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Aspirin Other Pneumonia Aspiration Health (Acetylsalicylic Professional Acid) PS 75 MG, TOTAL Other DAILY, Risperdal (Risperidone) SS ORAL 0.5 MG, BID, ORAL Iron SS Folic Acid C 22-Feb-2006 08:20 AM Page: 1941 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Augmentin C Date:02/11/04ISR Number: 4294698-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040200970 Age:80 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Foreign Risperdal Leukopenia Health (Risperidone) Professional Unspecified PS ORAL 0.5 MG , IN 1 DAY, ORAL : 2 -3 MG DAILY : 1 MG , IN 1 DAY, ORAL Date:02/11/04ISR Number: 4294704-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040104956 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anger Foreign Risperdal Hospitalization - C-Reactive Protein Health (Risperidone) Initial or Prolonged Increased Professional Unspecified PS ORAL 3 MG, IN 1 Other Depressed Level Of DAY, ORAL Consciousness : 4 MG , ORAL Drug Interaction Lithium Carbonate Haematuria (Lithium Carbonate) Injury Asphyxiation Unspecified SS ORAL 400 MG , IN 1 Mutism DAY, ORAL Neuroleptic Malignant Syndrome Pain Date:02/11/04ISR Number: 4294719-3Report Type:Expedited (15-DaCompany Report #IN-JNJFOC-20040103396 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Duodenal Ulcer Foreign Risperidone PS ORAL 2 DOSE(S), 2 Initial or Prolonged Eosinophil Count Study IN 1 DAY, Other Increased Health ORAL Iron Deficiency Anaemia Professional Quetiapine Jaundice (Quetiapine) Marrow Hyperplasia Capsules SS ORAL 2 DOSE(S), 2 Microcytic Anaemia IN 1 DAY, Pain In Extremity ORAL Palpitations Placebo (Placebo) Capsules SS ORAL 2 DOSE(S), 2 IN 1 DAY, ORAL Fefol C Date:02/12/04ISR Number: 4295121-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030905768 Age:84 YR Gender:Male I/FU:F Outcome PT Death Aortic Valve Incompetence Atrial Fibrillation Coma Dementia Alzheimer'S Type 22-Feb-2006 08:20 AM Page: 1942 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diastolic Dysfunction Dilatation Atrial Electrocardiogram T Wave Report Source Product Role Manufacturer Route Dose Duration Abnormal Health Risperdal Mitral Valve Incompetence Professional (Risperidone) Pericardial Effusion Tablets PS ORAL SEE IMAGE Pleural Calcification Coumadin (Warfarin Pleural Effusion Sodium) C Pneumonia Aspiration Atrovent Respiratory Distress (Inhalation) Sepsis Ipratropium Bromide C Ventricular Hypertrophy Pepcid (Famotidine) C Lanoxan (Digoxin) C Diflucan (Fluconazole) C Lasix (Furosemide) C Date:02/12/04ISR Number: 4295855-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040201927 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Hepatic Function Abnormal Health (Risperidone) PS ORAL 0.5 MG, IN 1 Neutropenia Professional DAY, ORAL Mianserin Hydrochloride (Mianserin Hydrochloride) SS ORAL ORAL Nicergoline (Nicergoline) C Lithium Carbonate (Lithium Carbonate) C Date:02/12/04ISR Number: 4296042-XReport Type:Expedited (15-DaCompany Report #NSADSS2002009796 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Contusion Consumer Risperdal Platelet Count Decreased Health (Risperidone) Professional Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Synthroid (Levothyroxine Sodium) C Restoril (Temazepam) C Date:02/13/04ISR Number: 4297442-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202059 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1943 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/13/04ISR Number: 4297834-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040103698 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Thrombocytopenia Health (Risperidone) Professional Unspecified PS ORAL 2 MG, ORAL; 6 MG, IN 1 DAY, ORAL Quetiapine Fumarate (Quetiapine Fumarate) SS ORAL ORAL; 300 MG, IN 1 DAY, ORAL; 100 MG, IN 1 DAY, ORAL; 75 MG, Date:02/13/04ISR Number: 4297838-0Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040104993 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acute Psychosis Foreign Risperdal Complications Of Maternal Health (Risperidone) Exposure To Therapeutic Professional Unspecified PS ORAL 3 MG, 1 IN 1 Drugs DAY, ORAL Refusal Of Treatment By Patient Ultrasound Antenatal Screen Abnormal Date:02/16/04ISR Number: 4295862-5Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0440849A Age: YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Aggression Lamictal PS Glaxosmithkline ORAL 50MG Per day 2 WK Agitation Risperdal SS Dyspnoea Remeron C Celexa C Zyprexa C Klonopin C Prednisone C Theophylline C Atrovent C Serevent C Glaxosmithkline Verapamil C Unspecified Medication C Date:02/17/04ISR Number: 4296294-6Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0429725A Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Lamotrigine PS Glaxosmithkline ORAL Neutropenia Clozapine SS ORAL 1 YR Protonix SS UNKNOWN Risperdal SS UNKNOWN Klonopin SS Cogentin C UNKNOWN Zoloft C UNKNOWN 22-Feb-2006 08:20 AM Page: 1944 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/04ISR Number: 4297663-0Report Type:Direct Company Report #CTU 212443 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Akathisia Zoloft PS Anxiety Paxil SS Drug Ineffective Lexapro SS Feeling Abnormal Prozac SS Pain Respiridol SS Restlessness Self-Injurious Ideation Suicidal Ideation Date:02/17/04ISR Number: 4297718-0Report Type:Direct Company Report #CTU 212464 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Risperdal 1 Mg PS ORAL 1 MG QD ORAL Respiration Abnormal Date:02/17/04ISR Number: 4298993-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040201395 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:02/17/04ISR Number: 4298996-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031101850 Age:91 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Company Unspecified PS 1 MBQ Representative Date:02/17/04ISR Number: 4299015-6Report Type:Expedited (15-DaCompany Report #A01200400550 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Accidental Exposure Health Talwin (Pentazocine) Convulsion Professional Tablet PS ORAL ORAL Eye Disorder Demerol - (Pethidine Muscle Spasticity Hydrochloride) SS Muscle Twitching Risperdal - Respiratory Fume (Risperidone) SS Inhalation Disorder Gravol - Tongue Disorder (Dimenhydrinate) - Solution SS INTRAVENOUS INTRAVENOUS NOS 22-Feb-2006 08:20 AM Page: 1945 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/04ISR Number: 4299212-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040104839 Age:71 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Throat Cancer Consumer Risperdal (Risperidone) Tablets PS ORAL 1.5 MG , 3 IN 1 DAY, ORAL Reminyl (Galantamine) Unspecified SS Date:02/17/04ISR Number: 4300470-3Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20040201560 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Atrophy Foreign Risperdal Initial or Prolonged Health (Risperidone) Professional Unspecified PS Haldol (Haloperidol) Tablets SS Lithionit (Lithium Sulfate) SS Pulmicort Turbuhaler (Budesonide) Powder C Glucophage (Metformin Hydrochloride) Film Coated C Trombyl (Acetylsalicylic Acid) Tablets C Torem (Torasemide) Tablets C Laktipex (Lactulose) Powder C Remeron (Mirtazapine) Tablets C Unknown (All Other Therapeutic Products) C Zopiclone (Zopiclone) Film Coated Tablet C Date:02/17/04ISR Number: 4300649-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040201533 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Risperidone Cardiac Failure Acute Health (Risperidone) Coma Professional Unspecified PS ORAL 2 & 3 & 6 MG, Drug Interaction IN 1 DAY, Fall ORAL Hypersomnia Olanzapine Restlessness (Olanzapine) SS ORAL 2.5 MG, IN 1 Sudden Death DAY, ORAL Psychotropic Agents (Antipsychotics) SS ORAL 1IN 1 AS 22-Feb-2006 08:20 AM Page: 1946 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report NECCESSARY, ORAL Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Bromazepam (Bromazepam) C Quazepam (Quazepam) C Triazolam (Triazolam) C Vegetamin (Vegetamin) C Date:02/17/04ISR Number: 4300660-XReport Type:Expedited (15-DaCompany Report #NSADSS2003002271 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Risperdal Initial or Prolonged Anxiety Consumer (Risperidone) Disability Cognitive Disorder Unspecified PS ORAL 0.5 & 1.25 & Delusion 150 MG, ORAL Fear - SEE IMAGE Hallucination Ritalin (Tablets) Mental Impairment Methylphenidate Mental Retardation Hydrochloride C Severity Unspecified Alesse 28 Pain (Unspecified) Paranoia Eugynon C Psychotic Disorder School Refusal Social Avoidant Behaviour Suicidal Ideation Suicide Attempt Tourette'S Disorder Tremor Weight Decreased Date:02/17/04ISR Number: 4300662-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031202796 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Foreign Risperdal Completed Suicide Health (Risperidone) Foreign Body Aspiration Professional Unspecified PS ORAL 2 & 6 MG, IN Mental Disorder 1 DAY, ORAL Polydipsia Brotizolam Pulmonary Oedema (Unspecified) Vomiting Brotizolam C Water Intoxication Trihexyphenidyl Hydrochloride C Flunitrazepam (Flunitrazepam) C Levomepromazine Maleate C Lithium Carbonate 22-Feb-2006 08:20 AM Page: 1947 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Lithium Carbonate) C Date:02/17/04ISR Number: 4300664-7Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20031200303 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Foreign Risperdal Initial or Prolonged Anal Dilatation Health (Risperidoen) PS ORAL 1 & 2 MG, IN Anuria Professional 1 DAY, ORAL Blood Creatinine Lasix Retard Increased (Furosemide) Difficulty In Walking Capsules C Faecal Incontinence Seloken Zoc Mobility Decreased (Metoprolol Muscle Rigidity Succinate) C Polyneuropathy Zocord (Simvastatin) C Spinal Disorder Levaxin (Levothyroxine Sodium) C Waran (Warfarin Sodium) Tablets C Monoket (Isosorbide Mononitrate) Tablets C Triobe (Triobe) C Pantoloc (Pantoprazole) C Date:02/18/04ISR Number: 4299955-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040201562 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Injection Site Reaction Foreign Risperdal Consta Neoplasm Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:02/18/04ISR Number: 4299957-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040201346 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dizziness Foreign Risperdal Consta Drug Interaction Health (Risperidone) Myocardial Infarction Professional Microspheres PS INTRAMUSCULAR SEE IMAGE Nausea Company Risperdal Representative (Risperidone) Unspecified SS ORAL 5 MG, 1 IN 1 DAY, ORAL Taxilan (Perazine) C Biperiden (Biperiden) C 22-Feb-2006 08:20 AM Page: 1948 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/04ISR Number: 4299963-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030901124 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholestasis Foreign Risperdal Initial or Prolonged Cytolytic Hepatitis Health (Risperidone) Other Granulomatous Liver Professional Unspecified PS ORAL SEE IMAGE Disease Haldol (Haloperidol) Hepatic Fibrosis Unspecified SS ORAL 20 MG, IN 1 Hepatitis DAY, ORAL Largactil (Chlorpromazine Hydrochloride) SS ORAL 200 MG, IN 1 DAY, ORAL Athymil (Mianserin Hydrochloride) SS ORAL 30 MG, IN 1 DAY, ORAL Temesta (Lorazepam) SS ORAL 5 MG, IN 1 DAY, ORAL Date:02/18/04ISR Number: 4300117-6Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20040102891 Age:59 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Foreign Risperdal Hospitalization - Cheyne-Stokes Respiration Health (Risperidone) Initial or Prolonged Depressed Level Of Professional Unspecified PS ORAL 0.5 MG, 2 IN Consciousness 1 DAY, ORAL Pulmonary Oedema Insulatard (Insulin Shock Human Injection, Isophane) C Prednisolon (Prednisolone) C Capoten (Captopril) C Sandimmun (Ciclosporin) C Trombyl (Acetylslicylic Acid) C Date:02/18/04ISR Number: 4300121-8Report Type:Expedited (15-DaCompany Report #EMADSS2001004137 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumonia Foreign Risperidone Initial or Prolonged Fall Health (Risperidone) Pyrexia Professional Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Seresta (Oxazepam) Unspecified SS 50 MG, UNKNOWN Tercian (Cyamemazine) Drops C 95 GTT Aricept (Donepezil Hydrochloride) Tablets C Speciafoldine (Folic Acid) C Tardyferon (Ferrous Sulfate) C 22-Feb-2006 08:20 AM Page: 1949 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/04ISR Number: 4300123-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040201568 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Foreign Risperdal Condition Aggravated Health (Risperidone) Granulocytopenia Professional Unspecified PS Infection Tavor (Lorazepam) C Date:02/18/04ISR Number: 4300527-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040200004 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperdal Initial or Prolonged Enterocolitis Health (Risperidone) Extrapyramidal Disorder Professional Unspecified PS ORAL 4 MG, IN 1 Ileus Paralytic DAY, ORAL Schizophrenia Dai-Kenchu-To (Unspecified) All Other Therapeutic Products C Magnesium Oxide (Unspecified) Magnesium Oxide C Lorazepam (Lorazepam) Unspecified C Pantethine (Pantethine) Unspecified C Antidiarrheals, Intestinal Regulators (All Other Therapeutic Products) C Mosapride Citrate (Mosapride Citrate), Unspecified C Dimeticone (Dimeticone) Unspecified C Distigmine Bromide (Distigmine Bromide) Unspecified) C Piperacillin Sodium (Piperacillin Sodium) Unspecified) C Date:02/18/04ISR Number: 4300538-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040104956 Age:24 YR Gender:Male I/FU:F Outcome PT Death Abulia Hospitalization - Anxiety Initial or Prolonged Autism Other C-Reactive Protein Increased Cardiac Arrest Condition Aggravated Depressed Level Of 22-Feb-2006 08:20 AM Page: 1950 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Consciousness Drug Interaction Dysphagia Fall Report Source Product Role Manufacturer Route Dose Duration Haematuria Foreign Risperdal Injury Asphyxiation Health (Risperidone) Insomnia Professional Unspecified PS ORAL 3 MG, IN 1 Neuroleptic Malignant DAY, ORAL Syndrome Lithium Carbonate Psychotic Disorder (Lithium Carbonate) Unspecified) SS ORAL 600 MG, IN 1 DAY, ORAL Psychotropic Agents (Antipsychotics) Unspecified C Nitrazepam (Nitrazepam) Unspecified) C Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) Unspecified C Levomepromazine Maleate (Levomepromazine Maleate) Unspecified C Flunitrazepam (Flunitrazepam) Unspecified C Date:02/18/04ISR Number: 4300548-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040201907 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Risperdal Phosphokinase Increased Health (Risperidone) Leukopenia Professional Unspecified PS ORAL 8 ML, IN 1 DAY, ORAL Lorazepam C Date:02/18/04ISR Number: 4300706-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202055 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Health Risperdal Professional (Risperidone) Unspecified PS ORAL 1 MG, 2 IN 1 DAY, ORAL Date:02/18/04ISR Number: 4300708-2Report Type:Expedited (15-DaCompany Report #NSADSS2003014805 Age:63 YR Gender:Female I/FU:F Outcome PT Death Alanine Aminotransferase Increased Aspartate Aminotransferase Increased 22-Feb-2006 08:20 AM Page: 1951 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Alkaline Phosphatase Increased Report Source Product Role Manufacturer Route Dose Duration Health Risperdal Professional (Risperidone) Unspecified PS ORAL 1 MG, 1 IN 1 DAY, ORAL Pamelor (Nortriptyline Hydrochloride) C Prinizide (Prinizide) C Zocor (Simvastatin) C Date:02/18/04ISR Number: 4300714-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030905351 Age:93 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Injury Consumer Risperdal Initial or Prolonged Contusion Health (Risperidone) Fall Professional Tablets PS ORAL 0.25 MG, 2 IN Loss Of Consciousness 1 DAY, ORAL Renal Failure Lotensin (Benazepril Hydrochloride) C Vioxx (Rofecoxib) C Adalat (Nifedipine) C Exelon (Rivastigmine Tartrate) C Senna (Senna) C Date:02/18/04ISR Number: 4301502-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031104673 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Consumer Risperdal Amnesia (Risperidone) Drooling Tablets PS ORAL SEE IMAGE Eyelid Disorder Haldol (Haloperidol) Hair Colour Changes Unspecified SS Intestinal Functional Cogentin Disorder (Benzatropine Muscle Atrophy Mesilate) SS Overdose Effexor (Venlafaxine Posture Abnormal Hydrochloride) C Suicide Attempt Tardive Dyskinesia Visual Acuity Reduced Date:02/19/04ISR Number: 4301508-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202650 Age:91 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Risperdal Professional (Risperidone) Company Tablets PS ORAL 1 MG, ORAL Representative 22-Feb-2006 08:20 AM Page: 1952 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/19/04ISR Number: 4301511-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202664 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:02/19/04ISR Number: 4301571-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202658 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.25 MG, 1 IN 1 DAY, ORAL Date:02/19/04ISR Number: 4301574-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031001878 Age:57 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Fibrosis Health Risperdal Other Weight Decreased Professional (Risperidone) Tablets PS 6-9MG AT HOUR OF SLEEP Avandia (Rosiglitazone Maleate) C Date:02/19/04ISR Number: 4301579-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202295 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:02/19/04ISR Number: 4301582-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202537 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Necrosis Health Risperdal Initial or Prolonged Painful Erection Professional (Risperidone) Priapism Tablets PS PATIENT TOOK ONLY 1 DOSE IN TOTAL Date:02/19/04ISR Number: 4301598-4Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040201902 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mutism Foreign Risperdal Consta Company (Risperidone) Representative Microspheres PS PATIENT RECEIVED RISPERIDONE ON 22-Feb-2006 08:20 AM Page: 1953 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 02-FEB-2004. Date:02/19/04ISR Number: 4301600-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040202732 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Pyrexia Health (Risperidone) PS ORAL ORAL Rash Professional Carbamazepine Thrombocytopenia (Carbamazepine) SS ORAL ORAL Date:02/20/04ISR Number: 4301937-4Report Type:Expedited (15-DaCompany Report #T03-GER-04833-01 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Ebixa (Memantine) PS ORAL 10 MG QD PO Initial or Prolonged Delusional Disorder, Study Risperidone SS ORAL 1 MG QD PO Persecutory Type Health Valproate (Valproate Fall Professional Sodium) C Femoral Neck Fracture Other Personality Disorder Restlessness Suicidal Ideation Date:02/20/04ISR Number: 4302062-9Report Type:Expedited (15-DaCompany Report #IN-JNJFOC-20040103396 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Risperidone PS ORAL 2 DOSE(S), 2 Initial or Prolonged Phosphatase Increased Study IN 1 DAY, Other Blood Chloride Increased ORAL Bone Marrow Depression Quetiapine Diarrhoea (Quetiapine) SS ORAL 2 DOSE(S), 2 Duodenal Ulcer IN 1 DAY, Eosinophilia ORAL Haematochezia Placebo (Placebo) SS ORAL 2 DOSE(S), 2 Helicobacter Infection IN 1 DAY, Hyperbilirubinaemia ORAL Infection Parasitic Fefol Fefol C Iron Deficiency Anaemia Jaundice Leukopenia Microcytic Anaemia Pain Pain In Extremity Palpitations Transfusion Reaction Date:02/20/04ISR Number: 4302114-3Report Type:Expedited (15-DaCompany Report #NSADSS2002009796 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Contusion Consumer Risperdal Thrombocytopenia Health (Risperidone) Professional Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL; 0.5 MG, 1 IN 1 DAY, ORAL; 22-Feb-2006 08:20 AM Page: 1954 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Synthroid (Levothyroxine Sodium) C Restoril (Temazepam) C Date:02/20/04ISR Number: 4302116-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040203245 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS Date:02/20/04ISR Number: 4302117-9Report Type:Expedited (15-DaCompany Report #NZ-JNJFOC-20031104437 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Fibrinogen Foreign Risperidone Hospitalization - Increased Health (Risperidone) Initial or Prolonged Cerebral Infarction Professional Solution PS ORAL 2 MG, IN 1 Cerebrovascular Accident DAY, ORAL Dialysis Risperidone Intracardiac Thrombus (Risperidone) Refusal Of Treatment By Solution SS ORAL 4 MG, IN 1 Patient DAY, ORAL Renal Failure Acute Risperidone Rhabdomyolysis (Risperidone) Solution SS ORAL 1 MG, IN 1 DAY, ORAL Risperidone (Risperidone) Solution SS ORAL 0.5 MG, 4 IN 1 DAY, ORAL Risperidone (Risperidone) Solution SS ORAL 1 MG, 2 IN 1 DAY, ORAL Antihypertensives (Antihypertensives) Unspecified C Date:02/20/04ISR Number: 4302118-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202679 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Risperdal Hospitalization - Congestive (Risperidone) Initial or Prolonged Lethargy Tablets PS ORAL 0.25 MG, 1 IN Oedema Peripheral 1 DAY, ORAL Pneumonia Xanax (Alprazolam) C Paxil (Paroxetine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 1955 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/20/04ISR Number: 4302153-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040203182 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Jaundice Foreign Risperdal Health (Risperidone Professional Unspecified PS ORAL ORAL Date:02/20/04ISR Number: 4302154-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040202598 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 1 MG, IN 1 Company DAY, ORAL Representative Date:02/20/04ISR Number: 4302159-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040202589 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Foreign Risperdal Initial or Prolonged Extrapyramidal Disorder Health (Risperidone) Nystagmus Professional Tablets PS ORAL 1 MG, IN 1 DAY, ORAL Previscan (Fluindione) C Loxen Lp (Nicardipine Hydrochloride) C Glucophage (Metformin Hydrochloride) C Glucor (Acarbose) C Date:02/20/04ISR Number: 4302162-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040203162 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Risperidone)Tablets PS ORAL 2 MG, 1 IN 1 Professional DAY, ORAL Company Representative Date:02/23/04ISR Number: 4301850-2Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0319907A Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Seroxat PS Glaxosmithkline Extrapyramidal Disorder Risperidone SS 6MG Per day 22-Feb-2006 08:20 AM Page: 1956 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/04ISR Number: 4302965-5Report Type:Direct Company Report #CTU 212801 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anaesthetic Complication Risperidone PS ORAL 0.5 MG PO Cardiac Cardiac Arrest Date:02/23/04ISR Number: 4303209-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040203074 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Injection Site Reaction Health Risperdal Consta Necrotising Fasciitis Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR INTRA-MUSCULA Representative R Date:02/23/04ISR Number: 4303215-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040102211 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Risperdal Anaemia Professional (Risperidone) PS ORAL 0.5 MG, 1 IN Blood Iron Decreased 1 DAY, ORAL Body Temperature Prinivil Increased (Lisinopril) C Cough Augmentin (Clavulin) C Cystitis Effexor-Xr Dyspnoea (Venlafaxine) C Enterococcal Infection Combivent Neoplasm (Combivent) C Oxygen Saturation Nicoderm (Nicotine) Decreased Patch C Pneumonia Aspiration Tachypnoea Treatment Noncompliance Upper Gastrointestinal Haemorrhage Date:02/23/04ISR Number: 4303323-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040202797 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Foreign Risperdal Consta Initial or Prolonged Study (Risperidone) Health Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Professional WEEK, INTRA-MUSCULA R Haldol-Janssen (Haloperidol) C Ranitidine (Ranitidine) C Risperdal (Risperidone) C Aescusan (Escin) C 22-Feb-2006 08:20 AM Page: 1957 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/23/04ISR Number: 4303329-0Report Type:Expedited (15-DaCompany Report #IN-JNJFOC-20040103396 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Lactate Foreign Risperidone- Blinded Initial or Prolonged Dehydrogenase Decreased Study (Risperidone) Other Duodenal Ulcer Health Tablets PS ORAL 2 DOSE (S), 2 Dyspnoea Exertional Professional IN 1 DAY, Eosinophilia ORAL Helicobacter Infection Quetiapine Hookworm Infection (Quetiapine) Hyperbilirubinaemia Capsules SS ORAL 2 DOSE (S), 2 Hypochromic Anaemia IN 1 DAY, Iron Deficiency Anaemia ORAL Jaundice Placebo (Placebo) Leukopenia Capsules SS ORAL 2 DOSE (S), 2 Marrow Hyperplasia IN 1 DAY, Mean Cell Volume ORAL Decreased Fefol (Capsules) Nematodiasis Fefol C Pallor Palpitations Platelet Count Abnormal Transfusion Reaction Date:02/23/04ISR Number: 4303348-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040203134 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Increased Foreign Risperdal Thrombocytopenia Health (Risperidone) Professional Unspecified PS 4 MG Date:02/23/04ISR Number: 4303349-6Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20030903295 Age:62 YR Gender:Male I/FU:F Outcome PT Death Adenoma Benign Life-Threatening Agitation Hospitalization - Blood Urea Increased Initial or Prolonged Cholecystitis Collapse Of Lung Confusional State Delirium Disorientation Gastrointestinal Hypomotility Hypotension Hypoxia Klebsiella Infection Lobar Pneumonia Lower Respiratory Tract Infection Pneumonia Pneumonia Aspiration Postoperative Ileus Pulmonary Embolism Pyrexia Respiratory Arrest Respiratory Failure 22-Feb-2006 08:20 AM Page: 1958 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sepsis Sputum Culture Positive Staphylococcal Infection Report Source Product Role Manufacturer Route Dose Duration Tachycardia Foreign Reminyl Health (Galantamine) Professional Unspecified PS ORAL 8 MG, 2 IN 1 DAY, ORAL Mirtazepine (Mirtazapine) SS ORAL 30 MG, 1 IN 1 DAY, ORAL Risperidone (Risperidone) SS Haloperidol (Haloperidol) SS Vioxx (Rofecoxib) C Lipitor (Atorvastatin) C Vitamin E (Tocopherol) C Vitamin C (Ascorbic Acid) C Folic Acid (Folic Acid) C Ginkgo Biloba (Ginkgo Biloba) C Date:02/23/04ISR Number: 4303351-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040103409 Age:93 YR Gender:Male I/FU:F Outcome PT Death Abnormal Behaviour Hospitalization - Aggression Initial or Prolonged Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Sodium Increased Blood Urea Increased C-Reactive Protein Increased Cardiac Arrest Choking Dehydration Delirium Depressed Level Of Consciousness Dizziness Drug Interaction Dysstasia Electrocardiogram Abnormal Excitability Haematocrit Decreased Haemoptysis Incoherent Insomnia Irritability Muscle Strain Myalgia 22-Feb-2006 08:20 AM Page: 1959 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Pain Report Source Product Role Manufacturer Route Dose Duration Physical Assault Foreign Risperidone Red Blood Cell Count Health (Risperidone) Decreased Professional Solution PS ORAL SEE IMAGE Respiratory Arrest Tiapride Somnolence Hydrochloride Sputum Abnormal (Tiapride Tachycardia Hydrohcoride) Tracheal Obstruction Usnpesicified SS ORAL SEE IMAGE Treatment Noncompliance Tamsulosin Urinary Incontinence Hydrochloride (Tamsulosin Hydrochloride) C Chlormadinone Acetate (Chlormadinone Acetate) C Prazosin Hydrochloride (Prazosin Hydrochloride) C Ethyl Icosapentate (Ethyl Icosapentate) C Date:02/23/04ISR Number: 4303430-1Report Type:Expedited (15-DaCompany Report #2004007834 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Geodon (Ziprasidone) PS Professional Risperidone Company (Risperidone) SS Representative Date:02/23/04ISR Number: 4303577-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202825 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Study Risperidone Initial or Prolonged Health (Risperidone) Professional Unspecified PS ORAL ORAL Olanzapine (Olanzapine) SS ORAL ORAL Quetiapine (Quetiapine) SS ORAL ORAL Ziprasidone (Ziprasidone) SS ORAL ORAL Perphenazine (Perphenazine) SS ORAL ORAL Lorazepam (Lorazepam) C 22-Feb-2006 08:20 AM Page: 1960 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/04ISR Number: 4303800-1Report Type:Direct Company Report #CTU 212993 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Risperdal 4 Mg PS ORAL 1 DAILY ORAL Initial or Prolonged Celexa C Stelazine C Date:02/24/04ISR Number: 4303818-9Report Type:Direct Company Report #CTU 213092 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oedema Peripheral Depakote Er 100 Q Po Rash Generalised Bid PS ORAL Risperdol 2 Mg Po Bid Hs SS ORAL 2 WK Thorazine 15 Mg Po D SS ORAL 2 WK Date:02/24/04ISR Number: 4304565-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040201927 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal Disorientation Health (Risperidone) Drug Interaction Professional Unspecified PS ORAL 0.5 MG, IN 1 Erythropenia DAY, ORAL; 1 Hepatic Function Abnormal MG, IN 1 DAY, Hepatic Steatosis ORAL Hepatocellular Damage Mianserin Insomnia Hydrochloride Leukopenia (Mianserin Liver Disorder Hydrochloride) Neutropenia Unspecified SS ORAL 10 MG, IN 1 Pyrexia DAY, ORAL; 30 MG, IN 1 DAY, ORAL Nicergoline (Nicergoline) Unspecified SS ORAL 15 MG, IN 1 DAY, ORAL Zopiclone (Zopiclone) Unspecified SS ORAL 10 MG, IN 1 DAY, ORAL Lithium Carbonate (Lithium Carbonate) Unspecified SS ORAL ORAL Zolpidem Tartrate (Zolpidem Tartrate) Unspecified SS ORAL 10 MG, IN 1 DAY, ORAL; 5 MG, IN 1 DAY, ORAL Paroxetine Hydrochloride Hydrate (Paroxetine) Unspecified C Nitrazepam (Nitrazepam) Unspecified C 22-Feb-2006 08:20 AM Page: 1961 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Brotizolam (Brotizolam) Unspecified C Amoxapine (Amoxapine) Unspecified C Sulpiride (Sulpiride) C Etizolam (Etizolam) C Date:02/25/04ISR Number: 4303874-8Report Type:Expedited (15-DaCompany Report #CH-GLAXOSMITHKLINE-B0323331A Age:25 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Deroxat PS Glaxosmithkline ORAL 40MG per day Initial or Prolonged Pleuritic Pain Risperidone SS ORAL 3MG per day Pulmonary Embolism Clotiapine SS ORAL 40MG per day Pulmonary Infarction Valproic Acid C ORAL 1000MG per Treatment Noncompliance day Nicoumalone C Date:02/25/04ISR Number: 4305813-2Report Type:Expedited (15-DaCompany Report #NSADSS2002032627 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL Date:02/25/04ISR Number: 4307128-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031201204 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Risperdal Drug Interaction Health (Risperidone) Drug Level Increased Professional Unspecified PS ORAL 2 MG, IN 1 Extrapyramidal Disorder DAY, ORAL Femur Fracture Fentanyl (Fentanyl) Post Procedural Unspecified SS Complication Timonil Restlessness (Carbamazepine) C Date:02/25/04ISR Number: 4307142-XReport Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040201902 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mutism Foreign Risperdal Consta Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Company WEEK, Representative INTRAMUSCULAR 22-Feb-2006 08:20 AM Page: 1962 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/04ISR Number: 4307144-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040201907 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Risperdal Phosphokinase Increased Health (Risperidone) Leukopenia Professional Unspecified PS ORAL 2 ML, IN 1 DAY, ORAL; 8 ML, 1 IN 1 DAY Risperdal (Risperidone) Solution SS 3 ML, 1 IN 1 DAY Lorazepam (Unspecified) Lorazepam C Date:02/25/04ISR Number: 4307146-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031201204 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Drug Level Increased Health (Risperidone) PS ORAL 2 MG, IN 1 Extrapyramidal Disorder Professional DAY, ORAL Femur Fracture Fentanyl (Fentanyl) SS Timonil (Carbamazepine) C Date:02/25/04ISR Number: 4307147-9Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20031005115 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) PS ORAL 2 MG, IN 1 Other Cardiac Failure Professional DAY, ORAL Haemoglobin Decreased Temesta (Lorazepam) C Pulmonary Oedema Flixotide White Blood Cell Count (Fluticasone) C Increased Accolate (Zafirlukast) C Serevent (Salmeterol Xinafoate) C Xanthium (Theophylline) C Date:02/25/04ISR Number: 4307148-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040103625 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Risperdal Initial or Prolonged Electrocardiogram Qt Health (Risperidone) PS ORAL 1 MG, IN 1 Prolonged Professional DAY, ORAL Fall Corvasal Haematoma (Molsidomine) C Hand Fracture Temesta (Lorazepam) C Malaise Fraxiparine Myocardial Infarction (Heparin-Fraction, Sinus Tachycardia Calcium Salt) C 22-Feb-2006 08:20 AM Page: 1963 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seropram (Citalopram Hydrobromide) C Cardensiel (Nicardipine Hydrochloride) C Risordan (Isosorbide Dinitrate) C Kardegic (Acetylsalic Lysine) C Date:02/25/04ISR Number: 4307149-2Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20040203137 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Electrocardiogram Qt Foreign Risperdal Other Corrected Interval Health (Risperidone) Prolonged Professional Tablets PS ORAL 4 MG, IN 1 DAY, ORAL; 3 MG, IN 1 DAY, ORAL; 3 MG, IN 1 DAY , Lamictal (Lamotrigine) Tablets C Edronax (Reboxetine) Tablets C Pradel (Lithium) Tablets C Trittico (Trazodone Hydrochloride) Tablets C Temesta (Lorazepam) Tablets C Dalmadorm (Flurazepam Hydrochloride) Tablets C Sortis (Atorvastatin Calcium) Tablets C Diamicron (Gliclazide) Tablets C Efexor (Venlafaxine Hydrochloride) Tablets C "Depakine Chrono" (Valproic Acid) Tablets C Date:02/25/04ISR Number: 4307153-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040202732 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Pyrexia Health (Risperidone) PS ORAL ORAL Rash Professional Carbamazepine Thrombocytopenia (Carbamazepine) SS ORAL ORAL Aspirin-Dialuminate (Bufferin) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 1964 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/25/04ISR Number: 4307158-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040203289 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Clostridium Colitis Foreign Risperdal Gallbladder Operation Health (Risperidone) PS Meningitis Staphylococcal Professional Post Procedural Complication Date:02/26/04ISR Number: 4305915-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040102666 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Risperdal Injury Asphyxiation Health (Risperidone) Professional Tablets PS 2 MG, 1 IN 1 DAY Seroquel (Quetiapine Fumarate) C Wellbutrin Sr (Bupropion Hydrochloride) C Eskalith Cr (Lithium Carbonate) C Date:02/26/04ISR Number: 4307109-1Report Type:Direct Company Report #CTU 213295 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Abnormal Risperdal 1 Mg Rash Janssen PS Janssen 1 MG BID Risperdal 2 Mg Janssen SS Janssen 1 MG QAM & 2 MG QHS Date:02/26/04ISR Number: 4307414-9Report Type:Expedited (15-DaCompany Report #200410862BCC Age:15 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Health Aleve Tablet 220mg Initial or Prolonged Convulsion Professional From Bayer Consumer Electrocardiogram Qt Other Care (Naproxen Prolonged Sodium) PS ORAL 2640 MG, Intentional Overdose ONCE, ORAL International Normalised Wellbutrin 150 Mg Ratio Decreased (Bupropion Lethargy Hydrochloride) SS ORAL 3750 MG, Suicide Attempt ONCE, ORAL Syncope Risperdal M-Tab Tachycardia Disintegrating Tablet 0.5 Mg From Janssen Pharmaceutica SS Janssen Pharmaceutical ORAL 12.5 MG, ONCE, ORAL Percocet (5/325) Endo Laboratories SS Endo Laboratories ORAL ONCE, ORAL 22-Feb-2006 08:20 AM Page: 1965 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/04ISR Number: 4307554-4Report Type:Direct Company Report #CTU 213368 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Risperdal 2 Mg Muscle Spasms Johnson& Johnson PS Johnson & Johnson ORAL 2 MG 3 TIMES ORAL Date:02/27/04ISR Number: 4308749-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040100055 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Company Unspecified PS ORAL 5 MG, IN 1 Representative DAY, ORAL Date:02/27/04ISR Number: 4308752-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040203935 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS Professional Date:02/27/04ISR Number: 4308754-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040205559 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Risperdal Professional (Risperidone) PS ORAL ORAL Company Lithium (Lithium) C Representative Date:02/27/04ISR Number: 4308758-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040203952 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Microspheres PS INTRAMUSCULAR INTRA-MUSCULA R Date:02/27/04ISR Number: 4308779-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040203875 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Foreign Risperdal Fracture Health (Risperidone) Leukocytosis Professional Unspecified PS ORAL 4 MG, IN 1 DAY, ORAL Levomepromazine Maleate (Levomepromazine Maleate) C Flunitrazepam (Flunitrazepam) C 22-Feb-2006 08:20 AM Page: 1966 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/27/04ISR Number: 4308810-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040105714 Age:89 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL 2.5 MG, 1 IN 1 DAY, ORAL Date:02/27/04ISR Number: 4308813-1Report Type:Expedited (15-DaCompany Report #NSADSS2002010071 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Activated Partial Health Risperdal Thromboplastin Time Professional (Risperidone) Prolonged Unspecified PS ORAL ORAL Coagulation Factor Ix Level Decreased Coagulation Factor Vii Level Decreased Coagulation Factor X Level Decreased Date:02/27/04ISR Number: 4308826-XReport Type:Expedited (15-DaCompany Report #2004UW00116 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Eye Pain Consumer Seroquel PS ORAL 300 MG HS PO Inflammation No Match SS Injury Corneal Risperdal SS Insomnia Zyprexa C Peripheral Coldness Nexium C Retinal Injury Geodon C Vitreous Floaters Lamisil C Vomiting Thiamine C Date:02/27/04ISR Number: 4308918-5Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040204801 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Toxicity Foreign Risperdal Initial or Prolonged Muscle Rigidity Health (Risperidone) Muscle Spasticity Professional Unspecified PS 2.5 MG, 2 IN 1 DAY Date:02/27/04ISR Number: 4308931-8Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040104001 Age:54 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Foreign Risperidal Sudden Death Health (Risperidone) Professional Tablets PS 2 MG Company Fluvoxamine Representative (Fluvoxamine) Tablets C Glibenclamide (Glibenclamide) Tablets C 22-Feb-2006 08:20 AM Page: 1967 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lisinopril (Lisinopril) Tablets C Date:02/27/04ISR Number: 4308975-6Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20040203230 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Consta Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 1 IN 15 DAY, INTRAMUSCULAR Tertensif (Indapamide) C Dianben (Metformin Hydrochloride) C Date:02/27/04ISR Number: 4309078-7Report Type:Expedited (15-DaCompany Report #DSA_24007_2004 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholestasis Foreign Temesta PS ORAL 5 MG QD PO Initial or Prolonged Granulomatous Liver Health Athymil SS ORAL 30 MG QD PO Disease Professional Haldol SS ORAL 20 MG QD PO Hepatic Fibrosis Other Largactil SS ORAL 200 MG QD PO Portal Hypertension Risperdal SS ORAL 10 MG QD PO Date:02/27/04ISR Number: 4309194-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040201533 Age:47 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Foreign Risperidone Asthenia Health (Risperidone) PS ORAL SEE IMAGE, Cardiac Arrest Professional ORAL Cardiac Failure Acute Olanzapine Coma (Olanzapine) SS ORAL 2.5 MG, IN 1 Delusion DAY, ORAL Drug Interaction Psychotropic Agents Fall (Antipsychotics) SS ORAL ORAL Fatigue Trihexyphenidyl Fear Hydrochloride Feeling Cold (Trihexyphenidyl Hypersomnia Hydrochloride) C Incoherent Biperiden Mydriasis Hydrochloride Respiratory Arrest (Biperiden Restlessness Hydrochloride) C Sudden Death Bromazepam Thought Blocking (Bromazepam) C Urinary Incontinence Quazepam (Quazepam) C Triazolam (Triazolam) C Vegetamin (Vegetamin) C 22-Feb-2006 08:20 AM Page: 1968 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/04ISR Number: 4308334-6Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12330429 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Abilify Tabs 15 Mg PS Otsuka Initial or Prolonged Hyponatraemia Professional Pharmaceutical Renal Failure Acute Company, Ltd. ORAL Rhabdomyolysis Abilify Tabs 15 Mg I Otsuka Serotonin Syndrome Pharmaceutical Vomiting Company, Ltd. ORAL Effexor I At bedtime Risperdal I Topamax I Zonegran I Date:03/01/04ISR Number: 4308701-0Report Type:Direct Company Report #CTU 213452 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypothermia Risperidone PS Initial or Prolonged Date:03/01/04ISR Number: 4309533-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040203333 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delayed Recovery From Foreign Risperdal Anaesthesia Health (Risperidone) Drug Interaction Professional Unspecified PS ORAL 2 MG, 2 IN 1 Post Procedural DAY, ORAL Complication General Anaesthetic Psychotic Disorder (Anaesthetics, Somnolence General) SS Citalopram (Citalopram) C Date:03/01/04ISR Number: 4309536-5Report Type:Expedited (15-DaCompany Report #AT-JNJFOC-20040204303 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Foreign Risperdal Gastroenteritis Health (Risperidone) Sedation Professional Tablets PS ORAL SEE IMAGE Benzodiazepine (Benzodiazepine) SS Lisinopril + Hydrochlorothiazide C Dusodril Retard (Naftidrofuryl Oxalate)Tablets C Norvasc (Amlodipine Besialte)Tablets C Vibramycin (Doxycycline Hyclate) C 22-Feb-2006 08:20 AM Page: 1969 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/04ISR Number: 4309537-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040204788 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradyarrhythmia Foreign Reminyl Drug Interaction Health (Galantamine) Malaise Professional Tablets PS ORAL 8 MG, 2 IN 1 DAY, ORAL Risperdal (Risperidone) Tablets SS ORAL 1.5 MG, ORAL Seloken (Metoprolol Tartrate) SS ORAL 50 MG, ORAL Ebixa (Memantine Hydrochloride) C Equanil (Meprobamate) C Date:03/02/04ISR Number: 4310875-2Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040204307 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Foreign Risperdal Health (Risperidone) Professional Tablets PS SEE IMAGE Cedocard Retard (Bezafibrate) Tablet C Selokeen (Metoprolol Tartrate) Tablets C Thyrax (Levothyroxine) Tablets C Remeron (Mirtazapine) Tablets C Date:03/02/04ISR Number: 4310876-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040203898 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Enuresis Foreign Risperdal Health (Risperidone) PS ORAL 1 MG, 1 IN 1 Professional DAY, ORAL Paroxetine (Paroxetine) C Date:03/02/04ISR Number: 4310877-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031003882 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Risperdal Complications Of Maternal Health (Risperidone) Exposure To Therapeutic Professional Unspecified PS ORAL 5 MG, IN 1 Drugs DAY, ORAL Infection Maternal Condition Affecting Foetus Maternal Drugs Affecting Foetus 22-Feb-2006 08:20 AM Page: 1970 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/02/04ISR Number: 4310880-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040203972 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Consta Neutrophil Count Health (Risperidone) Decreased Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:03/02/04ISR Number: 4310890-9Report Type:Expedited (15-DaCompany Report #2004011077 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Sertraline Phosphokinase Increased Health (Sertraline) PS ORAL 100 MG Drug Interaction Professional (DAILY), ORAL Dyspnoea Risperidone Myalgia (Risperidone) SS ORAL 4 MG (DAILY), Psychotic Disorder ORAL Date:03/02/04ISR Number: 4311142-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030901124 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholestasis Foreign Risperdal Initial or Prolonged Chronic Hepatitis Health (Risperidone) Other Cytolytic Hepatitis Professional Unspecified PS ORAL 4 MG, IN 1 Drug Interaction DAY, ORAL; 10 Granulomatous Liver MG, IN 1 DAY, Disease ORAL Hepatic Fibrosis Haldol (Haloperidol) Portal Hypertension Unspecified SS ORAL 20 MG, IN 1 DAY, ORAL Largactil (Chlorpromazine Hydrochloride) SS ORAL 200 MG, IN 1 DAY, ORAL Athymil (Mianserin Hydrochloride) SS ORAL 30 MG, IN 1 DAY, ORAL Temesta (Lorazepam) SS ORAL 5 MG, IN 1 DAY, ORAL Date:03/02/04ISR Number: 4311144-7Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20040201560 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Atrophy Foreign Risperdal Initial or Prolonged Parkinson'S Disease Health (Risperidone) Professional Unspecified PS Haldol (Haloperidol) Tablets SS Lithionit (Lithium Sulfate) SS Pulmicort Turbuhaler (Budesonide) Powder C Glucophage 22-Feb-2006 08:20 AM Page: 1971 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Metformin Hydrochloride) C Trombyl (Acetylsalicylic Acid) C Torem (Torasemide) C Laktipex (Lactulose) C Remeron (Mirtazapine) C Unknown (All Other Therapeutic Products) C Zopiclone (Zopiclone) C Date:03/02/04ISR Number: 4311150-2Report Type:Expedited (15-DaCompany Report #2004199992US Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Study Celebrex (Celecoxib) Hospitalization - Coma Consumer Capsule PS ORAL QD, ORAL Initial or Prolonged Haemorrhagic Stroke Health Risperdal Psychotic Disorder Professional (Risperidone) SS Transient Ischaemic Attack Date:03/02/04ISR Number: 4311155-1Report Type:Expedited (15-DaCompany Report #2003UW13875 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Study Risperidone PS TITRATION Initial or Prolonged White Blood Cell Count Health Risperidone SS 4 CAPS Required Decreased Professional Risperidone SS 6 CAPS Intervention to Zyprexa C Prevent Permanent Impairment/Damage Date:03/03/04ISR Number: 4311680-3Report Type:Direct Company Report #CTU 213738 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Risperidone PS ORAL 4 MG ONCE Initial or Prolonged Chromaturia DAILY ORAL Neuroleptic Malignant Syndrome Rhabdomyolysis Date:03/03/04ISR Number: 4311935-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031105385 Age:80 YR Gender:Female I/FU:F Outcome PT Death Coma Hospitalization - Confusional State Initial or Prolonged Disorientation Dry Mouth Extrapyramidal Disorder Orthostatic Hypotension Pulmonary Congestion 22-Feb-2006 08:20 AM Page: 1972 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Septic Shock Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Risperidone) Professional Tablets PS ORAL 0.5 MG, 2 IN Company 1 DAY, ORAL Representative Sectral (Acebutolol Hydrochloride) C "Cacit D3" (Calcium With Vitamin D) C Fosamax (Alendronate Sodium) C Imovane (Zopiclone) C Diamicron (Gliclazide) C Date:03/03/04ISR Number: 4311936-4Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040205705 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Disorder Foreign Risperdal Swelling Face Health (Risperidone) Professional Tablets PS ORAL 1 MG, ORAL Date:03/03/04ISR Number: 4311937-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040204777 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Risperdal Initial or Prolonged Health (Risperidone) Professional Unspecified PS ORAL 1 MG, IN 1 DAY, ORAL Persantin Retard (All Other Theraupeutic Products) C Aspirin (Acetylsalicyclic Acid) C Digoxin (Digoxin) C Frusemide (Furosemide) C Date:03/03/04ISR Number: 4311939-XReport Type:Expedited (15-DaCompany Report #ZA-JNJFOC-20031202196 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenopia Foreign Risperdal Astigmatism Health (Risperidone) Colour Blindness Professional Unspecified PS ORAL ORAL Diplopia Olanzapine Drug Interaction (Olanzapine) SS ORAL 15 MG, 1 IN 1 Vision Blurred DAY ORAL Visual Disturbance Lamotrigine C 22-Feb-2006 08:20 AM Page: 1973 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/04ISR Number: 4311950-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040204759 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lower Respiratory Tract Foreign Risperdal Consta Infection Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:03/03/04ISR Number: 4311951-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040204784 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Risperdal Initial or Prolonged Fall Health (Risperidone) Professional Unspecified PS ORAL 1.5 MG, IN 1 DAY, ORAL; 0.75 MG, IN 1 DAY, ORAL Trimetazadine (Trimetazadine) Tablets C Aricept (Donepezil Hydrochloride) C Stilnox (Zolpidem) C Date:03/03/04ISR Number: 4312274-6Report Type:Expedited (15-DaCompany Report #2004AP00927 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Condition Aggravated Literature Bupivacaine PS INTRADISCAL Intervention to Drug Interaction Health (INTRASPINAL) 12 MG IS Prevent Permanent Hypotension Professional Preservative Free Impairment/Damage Morphine SS INTRADISCAL (INTRASPINAL) 0.2 MG IS Fentanyl SS INTRADISCAL (INTRASPINAL) 10 UG IS Risperidone SS 2 MG HS Lithium C Date:03/03/04ISR Number: 4312400-9Report Type:Expedited (15-DaCompany Report #001-0945-M0200657 Age:44 YR Gender:Female I/FU:F Outcome PT Hospitalization - Agitation Initial or Prolonged Ankle Fracture Disability Bacteraemia Other Cervicitis Decreased Appetite Depression Drug Hypersensitivity Dysgeusia Dysphagia Facial Bones Fracture Gastrointestinal Disorder Gastrointestinal Infection 22-Feb-2006 08:20 AM Page: 1974 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypersensitivity Hypersomnia Hypoglycaemia Report Source Product Role Manufacturer Route Dose Duration Laboratory Test Abnormal Consumer Neurontin Macroglossia Health (Gabapentin) PS ORAL 1800 MG Nausea Professional DAILY, ORAL Oesophageal Disorder Risperidone Ovarian Infection (Risperidone) SS Overdose Lamotrigine Pain (Lamotrigine) C Pitting Oedema Lithium Carbonate Road Traffic Accident (Lithium Carbonate) C Sialoadenitis Clonazepam Somatisation Disorder (Clonazepam) C Speech Disorder Methylphenidate Swollen Tongue Hydrochloride Traumatic Brain Injury (Methylphenidate Upper Respiratory Tract Hydrochloride) C Infection Levothyroxine Sodium Vomiting (Levothyroxine Sodium) C Liothyronine Sodium (Liothyronine Sodium) C Sertraline Hydrochloride (Sertraline Hydrochloride) C Pilocarpine Hydrochloride (Pilocarpine Hydrochloride) C Metoprolol Succinate (Metoprolol Succinate) C Lansoprazole (Lansoprazole) C Hyoscyamine Sulfate (Hyoscyamine Sulfate) C Diltiazem Hydrochloride (Diltiazem Hydrochloride) C Bupropion Hydrochloride (Bupropion Hydrochloride) C Celebrex (Celecoxib) C Quetiapine Fumarate (Quetiapine Fumarate) C Metoprolol Tartrate (Metoprolol Tartrate) C Citalopram Hydrobromide (Citalopram Hydrobromide) C Olanzapine (Olanzapine) C 22-Feb-2006 08:20 AM Page: 1975 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Omeprazole (Omeprazole) C Nasal Preparations C Nefazodone Hydrochloride (Nefazodone Hydrochloride) C Totolin (Guaifenesin, Phenylpropanolamine Hydrochloride) C Meclozine (Meclozine) C Fluticasone Propionate (Fluticasone Propionate) C Trimethobenzamide Hydrochloride (Trimethobenzamide Hydrochloride) C Respaire-Sr-120 (Guaifenesin, Pseudoephedrine Hydrochloride) C Date:03/03/04ISR Number: 4312406-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040300045 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Unspecified PS Date:03/03/04ISR Number: 4312408-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040205543 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Tablets PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Date:03/03/04ISR Number: 4312411-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040205323 Age:40 YR Gender:Male I/FU:I Outcome PT Hospitalization - Alcohol Withdrawal Initial or Prolonged Syndrome Blood Creatine Phosphokinase Increased Bradyarrhythmia Dizziness Electrocardiogram St-T Segment Abnormal Gastritis Alcoholic Hypotension Psychotic Disorder 22-Feb-2006 08:20 AM Page: 1976 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rhabdomyolysis Sinus Bradycardia Sinus Tachycardia Report Source Product Role Manufacturer Route Dose Duration Tachycardia Literature Risperdal Health (Risperidone) Professional Unspecified PS 2 MG, IN 1 DAY Paroxetine (Paroxetine) C Date:03/03/04ISR Number: 4312414-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040100275 Age:56 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 1 MG, 2 IN 1 DAY, ORAL Toprol Xl (Metoprolol Succinate) C Depakote (Valproate Semisodium) C Zoloft (Sertraline Hydrochloride) C Date:03/03/04ISR Number: 4312493-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040105146 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Hypersensitivity Health Risperdal Initial or Prolonged Shock Professional (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Haldol (Unspecified) Haloperidol C Date:03/04/04ISR Number: 4313326-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040205101 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Foreign Risperdal Consta Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR INTRA-MUSCULA R Date:03/04/04ISR Number: 4313332-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040205723 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradyarrhythmia Foreign Reminyl Bradycardia Health (Galantamine) Drug Interaction Professional Unspecified PS ORAL 8 MG, ORAL Risperdal (Risperidone) Tablets SS ORAL 1 MG, ORAL Seloken (Metoprolol 22-Feb-2006 08:20 AM Page: 1977 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tartrate) Unknown SS ORAL 350 MG, ORAL Ebixa (Memantine Hydrochloride) C Hemigoxine (Digoxin) C Mopral (Omeprazole) C Imovane (Zopiclone) C Triflucan (Fluconazole) Tablets C Date:03/04/04ISR Number: 4313334-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031204663 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lethargy Health Risperdal Sudden Death Professional (Risperidone) Company Tablets PS ORAL 0.25 MG, 1 IN Representative 1 DAY, ORAL L-Thyroxine (Levothyroxine Sodium) C Norvasc (Amlodipine Besilate) C Atenolol (Atenolol) C Coumadin (Warfarin Sodium) C Lipitor (Atorvastatin) C Date:03/05/04ISR Number: 4313590-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040300134 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Asphyxiation Consumer Risperdal Respiratory Fume Health (Risperidone) Inhalation Disorder Professional Unspecified PS Date:03/05/04ISR Number: 4313625-9Report Type:Expedited (15-DaCompany Report #04H-163-0251152-00 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Caesarean Section Literature Morphine Sulfate Intervention to Complications Of Maternal Health 1mg/Ml Injection, Prevent Permanent Exposure To Therapeutic Professional Preserv. Free, Usp, Impairment/Damage Drugs 10ml Ampule Drug Interaction (Morphine Sulfate) PS INTRADISCAL Heart Rate Increased (INTRASPINAL) 0.2 MG, NOT Hypotension REPORTED, INTRASPINAL Bupivacaine Hcl 0.75% Injection, Usp (Bupivacaine Hydrochloride Injection) SS INTRADISCAL (INTRASPINAL) 12 MG, INTRASPINAL Fentanyl SS INTRADISCAL (INTRASPINAL) 10 MCG, INTRASPINAL 22-Feb-2006 08:20 AM Page: 1978 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperidone SS 2 MG, EVERY NIGHT Lithium C Date:03/05/04ISR Number: 4313900-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040201346 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Foreign Risperdal Consta Increased Health (Risperidone) Dizziness Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Drug Interaction Company WEEK; Glucose Tolerance Test Representative INTRA-MUSCULA Abnormal R (SEE IMAGE) Myocardial Infarction Risperdal Nausea (Risperidone) Unspecified SS ORAL 5 MG, IN 1 DAY; ORAL Taxilan (Perazine) C Biperiden C Date:03/05/04ISR Number: 4313901-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040205470 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Acute Foreign Risperdal Consta Drug Level Increased Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:03/05/04ISR Number: 4314039-8Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20031005115 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) Other Cardiac Failure Professional Unspecified PS ORAL 2 MG, IN 1 Haemoglobin Decreased DAY, ORAL Pulmonary Oedema Temesta (Lorazepam) C White Blood Cell Count Flixotide Increased (Fluticasone) C Accolate (Zafirlukast) C Serevent (Salmeterol Xinafoate) C Xanthum (Theophylline) C Trazolan (Trazodone Hydrochloride) C Mesulid (Nimesulide) C Serlain (Sertraline) C 22-Feb-2006 08:20 AM Page: 1979 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/05/04ISR Number: 4314042-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031104079 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 7 MG, IN 1 DAY, ORAL Timiperone (Timiperone) C Date:03/08/04ISR Number: 4314057-XReport Type:Direct Company Report #CTU 214028 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Alcohol Use Risperidone 2 Mg Tab PS ORAL 1 MG HS ORAL Intervention to Drug Abuser Quetiapine 100mg Tab SS ORAL 50 MG HS ORAL Prevent Permanent Overdose Augmentin C Impairment/Damage Priapism Vicodin C Treatment Noncompliance Citalopram C Sertraline C Date:03/08/04ISR Number: 4314454-2Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20030903295 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Reminyl Life-Threatening Blood Urea Increased Health (Galantamine) Hospitalization - Cholecystitis Professional Unspecified PS ORAL 8 MG, 2 IN 1 Initial or Prolonged Confusional State DAY, ORAL Delirium Mirtazepine Disorientation (Mirtazapine) Hypotension Unknown SS ORAL 30 MG, 1 IN 1 Hypoxia DAY, ORAL Klebsiella Infection Risperidone Lower Respiratory Tract (Risperidone) Infection Unspecified SS Pneumonia Haloperidol Pneumonia Aspiration (Haloperidol) Postoperative Ileus Unspecified SS Pulmonary Embolism Vioxx (Rofecoxib) C Respiratory Arrest Lipitor Respiratory Distress (Atorvastatin) C Respiratory Failure Vitamin E Sepsis (Tocopherol) C Staphylococcal Infection Vitamin C (Ascorbic Tachycardia Acid) C Urine Output Decreased Folic Acid (Folic Acid) C Ginkgo Biloba (Ginkgo Biloba) C Date:03/08/04ISR Number: 4314459-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040206106 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Risperdal Consta Drug Interaction Health (Risperidone) Murder Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 22-Feb-2006 08:20 AM Page: 1980 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Unspecified SS ORAL 6 MG, 1 IN 1 DAY, ORAL Date:03/08/04ISR Number: 4314463-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040202797 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Risperdal Consta Initial or Prolonged Schizophrenia Study (Risperidone) Health Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Professional WEEK, INTRA-MUSCULA R Haldol-Janssen (Haloperidol) C Ranitine (Ranitidine) C Risperdal (Risperidone) C Aescusan (Escin) C Date:03/08/04ISR Number: 4314599-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040104306 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cyanosis Foreign Risperdal Other Dyspnoea Health (Risperidone) Laryngospasm Professional Tablets PS ORAL 2 MG, 1 IN 1 Oculogyration DAY, ORAL Haldol (Injection) Haloperidol C Date:03/08/04ISR Number: 4314683-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040205524 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Risperdal Initial or Prolonged Depressed Level Of Health (Risperidone) Other Consciousness Professional Tablets PS ORAL 1 MG, 1 IN 1 Electroencephalogram DAY, ORAL Abnormal Topalgic (Tramadol Epilepsy Hydrochloride) Intestinal Obstruction Unspecified SS ORAL ORAL Paresis Triatec (Ramipril) SS ORAL ORAL Tremor Aricept (Donepezil Hydrochloride) SS ORAL ORAL Levothyroxine C 22-Feb-2006 08:20 AM Page: 1981 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/04ISR Number: 4314762-5Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040206104 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal Initial or Prolonged Cardiomegaly Health (Risperidone) Dyspnoea Professional Unspecified PS 8 MG, IN 1 Hypothermia DAY; IN 1 DAY Overdose Oxygen Saturation Decreased Rhonchi Somnolence Suicide Attempt Transfusion Reaction Date:03/08/04ISR Number: 4314764-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031202796 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Risperdal Foreign Body Aspiration Health (Risperidone) Injury Asphyxiation Professional Unspecified PS ORAL 2 MG, IN 1 Mental Impairment DAY, ORAL; 6 Polydipsia MG, IN 1 DAY, Pulmonary Oedema ORAL Vomiting Brotizolam Water Intoxication (Brotizolam) C Weight Increased Trihexyphenidyl Hydrochloride (Trihexypnehnidyl Hydrochloride) C Flunitrazepam (Flunitrazepam) C Levomepromazine Maleate (Levomepromazine Maleate) C Lithium Carbonate (Lithium Carbonate) C Date:03/08/04ISR Number: 4314766-2Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20040300015 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Calcium Increased Foreign Risperdal Initial or Prolonged Bundle Branch Block Left Health (Risperidone) Bundle Branch Block Right Professional Tablets PS ORAL 1 MG, 1 IN 1 Confusional State DAY, ORAL Drug Interaction Efexor (Venlafaxine General Physical Hydrochloride) Condition Abnormal Tablets SS ORAL 150 MG, ORAL Nocturia Lithionit (Lithium Sulfate) Tablets SS ORAL 126 MG, ORAL 22-Feb-2006 08:20 AM Page: 1982 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/08/04ISR Number: 4314768-6Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20030802863 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Sensation In Eye Foreign Risperdal Arrhythmia Consumer (Risperidone) Blood Iron Decreased Health Unspecified PS ORAL 4 MG, IN 1 Cardiac Disorder Professional DAY, ORAL; 3 Diarrhoea MG, IN 1 DAY, Drug Ineffective ORAL Drug Level Increased Oxazepam (Oxazepam) Dry Mouth Tablets C Dyskinesia Librium Dystonia (Chlordiazepoxide Emotional Disorder Hydrochloride) C Extrapyramidal Disorder Thyrax Face Oedema (Levothyroxine) C Fatigue Gastric Disorder Generalised Oedema Headache Hypothyroidism Influenza Keratoconjunctivitis Sicca Malaise Musculoskeletal Stiffness Oedema Peripheral Psychotic Disorder Strabismus Stress Syncope Tongue Disorder Urinary Incontinence Date:03/09/04ISR Number: 4314252-XReport Type:Direct Company Report #CTU 214105 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Respiridone 1 Mg Tab Initial or Prolonged Diabetic Ketoacidosis Janssen Disability Pharmaceuticals PS Janssen Pharmaceuticals ORAL 1 MG DAILY ORAL Trazodone C Date:03/10/04ISR Number: 4315937-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040104956 Age:24 YR Gender:Male I/FU:F Outcome PT Death Abulia Hospitalization - Autism Initial or Prolonged Cardiac Arrest Other Chromaturia Drug Interaction Dysphagia Dystonia Fall Injury Asphyxiation Insomnia 22-Feb-2006 08:20 AM Page: 1983 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Tremor Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Risperidone) PS ORAL SEE IMAGE Professional Lithium Carbonate (Lithium Carbonate) SS ORAL SEE IMAGE Psychotropic Agents (Antipsychotics) C Nitrazepam (Nitrazepam) C Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Levomepromazine Maleate (Levomepromazine Maleate) C Flunitrazepam (Flunitrazepam) C Date:03/11/04ISR Number: 4316472-7Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040203501 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Foreign Risperdal Lymphopenia Health (Risperidone) PS Professional Losec (Omeprazole) C Date:03/11/04ISR Number: 4316473-9Report Type:Expedited (15-DaCompany Report #APCDSS2003000581 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Foreign Risperidone Initial or Prolonged Depressed Level Of Health (Risperidone) Consciousness Professional Tablets PS SEE IMAGE Diabetic Ketoacidosis Caffeine Anhydrous Neuroleptic Malignant (Caffeine) C Syndrome Biguanide Overdose (Biguanides) C Rhabdomyolysis Suicide Attempt Date:03/11/04ISR Number: 4316476-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040300699 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gynaecomastia Foreign Risperdal Initial or Prolonged Hyperprolactinaemia Health (Risperidone) PS ORAL 1 DOSE (S),IN Parkinson'S Disease Professional 1 DAY,ORAL Ventricular Tachycardia Noctran (Noctan 10) Tablets C 22-Feb-2006 08:20 AM Page: 1984 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/11/04ISR Number: 4316483-1Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20040203213 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Risperdal Hyponatraemia Health (Risperidone) PS ORAL 2 MG, IN 1 Neuroleptic Malignant Professional DAY, ORAL Syndrome Lamotrigine (Lamotrigine) SS SEE IMAGE Fluvoxamine (Fluvoxamine) C Date:03/11/04ISR Number: 4316488-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040201239 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Eyelid Oedema Foreign Risperdal Consta Face Oedema Health (Risperidone) Rash Erythematous Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Rash Pruritic WEEK, INTRA-MUSCULA R Risperdal (Risperidone) C Thyroxine (Levothyroxine Sodium) C Amoxycillin (Amoxicillin) C Date:03/11/04ISR Number: 4316732-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040206376 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Complications Of Maternal Literature Risperidone Exposure To Therapeutic Health (Risperidone) PS 2 MG Drugs Professional Fentanyl (Fentanyl) SS Drug Level Decreased Lithium (Lithium) C Heart Rate Increased Hypotension Date:03/11/04ISR Number: 4316736-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040300650 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL ORAL Professional Date:03/12/04ISR Number: 4317045-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202295 Age:90 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Risperdal Professional (Risperidone) Unspecified PS 22-Feb-2006 08:20 AM Page: 1985 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/04ISR Number: 4317047-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031000774 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Consumer Risperdal Atrial Fibrillation (Risperidone) Gait Disturbance Tablets PS ORAL ORAL Posture Abnormal Tardive Dyskinesia Date:03/12/04ISR Number: 4317050-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040102954 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Risperdal Professional (Risperidone) Unspecified PS Zoloft (Sertraline Hydrochloride) C Date:03/12/04ISR Number: 4317116-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040301513 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Consta Neutropenia Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Company WEEK, Representative INTRA-MUSCULA R Date:03/12/04ISR Number: 4317160-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040301560 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Consta Electrocardiogram Change Health (Risperidone) Electrocardiogram Qt Professional Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN Corrected Interval 2 WEEK, Prolonged INTRA-MUSCULA R Risperdal (Risperidone) Unspecified SS ORAL 7 MG, ORAL Carbimazol (Carbimazole) C Date:03/12/04ISR Number: 4317281-5Report Type:Expedited (15-DaCompany Report #AT-JNJFOC-20040300547 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Risperdal Initial or Prolonged Left Ventricular Failure Health (Risperidone) Professional Tablets PS ORAL 1 MG, IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1986 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/04ISR Number: 4317284-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040301453 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Foreign Risperdal Other Road Traffic Accident Health (Risperidone) Professional Unspecified PS ORAL SEE IMAGE Flunitrazepam (Flunitrazepam) C Adrenocortical Hormone Preparations (Corticotropin) C Antibiotic Preparations (Antibiotics) C Diuretics (Diuretics) C Date:03/12/04ISR Number: 4317286-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031100012 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Reaction Foreign Risperdal Excitability Health (Risperidone) Gait Disturbance Professional Unspecified PS ORAL SEE IMAGE Incontinence Cyclosporin Open Angle Glaucoma (Ciclosporin) C Vision Blurred Penicillin (Benzylpenicillin Sodium) C Septrin (Bactrim) C Prednisolone (Prednisolone) C Fluconazole (Fluconazole) C Alphagan (Brimonidine Tartrate) C Trusopt (Dorzolamide Hydrochloride) C Date:03/12/04ISR Number: 4317540-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040301200 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS 0.5 - 1.0 MG TWICE DAILY Date:03/12/04ISR Number: 4317541-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040301766 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 1987 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/04ISR Number: 4317543-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040301911 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS Date:03/12/04ISR Number: 4317544-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040301202 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:03/12/04ISR Number: 4317566-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040301573 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Pain Foreign Risperdal Hospitalization - Cerebrovascular Accident Health (Risperidone) Initial or Prolonged Drug Interaction Professional Unspecified PS ORAL 0.5 MG, IN 1 Urinary Retention DAY, ORAL Urinary Tract Infection Dominal (Prothipendyl Hydrochloride) SS ORAL SEE IMAGE Calcium Carbonate (Calcium Carbonate) C Date:03/12/04ISR Number: 4317567-4Report Type:Expedited (15-DaCompany Report #GT-JNJFOC-20040301623 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Risperdal Brain Oedema Health (Risperidone) Cyanosis Professional Unspecified PS SEE IMAGE Encephalitis Hallucination Hypotension Loss Of Consciousness Muscle Rigidity Date:03/15/04ISR Number: 4318390-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040301111 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Risperdal Intentional Self-Injury Health (Risperidone) Professional Unspecified PS ORAL 2 MG, IN 1 DAY, ORAL Haloperidol (Haloperidol) Unspecified SS ORAL 12 MG, IN 1 DAY, ORAL; 10 MG, IN 1 DAY, ORAL Zotepine (Zotepine) 22-Feb-2006 08:20 AM Page: 1988 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablets SS ORAL 40 MG, IN 1 DAY, ORAL; 20 MG, IN 1 DAY, ORAL; 25 MG, IN 1 DAY, Biperiden (Biperidine) Powder C Trihexyphenidyl (Trihexyphenidyl) Powder C Lormetazepam (Lormetazepam) Unspecified C Flunitrazepam (Flunitrazepam) Unspecified C Date:03/15/04ISR Number: 4318402-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040301613 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Risperdal Initial or Prolonged Drug Interaction Health (Risperidone) Hypotonic Urinary Bladder Professional Unspecified PS ORAL SEE IMAGE Urinary Retention Remergil (Mirtazapine) SS ORAL SEE IMAGE Tavor (Lorazepam) SS ORAL IN 1 DAY, ORAL Edronax (Reboxetine) SS ORAL 4 MG, IN 1 DAY, ORAL Date:03/15/04ISR Number: 4318403-2Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20040105085 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Foreign Risperdal Decreased Health (Risperidone) Bruxism Professional Unspecified PS SEE IMAGE Hyperkinesia Date:03/15/04ISR Number: 4318615-8Report Type:Direct Company Report #CTU 214391 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Arthralgia Risperdal Tab 0.5 Mg PS ORAL 0.5 MG ORAL Complex Partial Seizures PER DAY Diarrhoea Lexapro C Disturbance In Attention Drug Withdrawal Syndrome Dyskinesia Dysstasia Eye Movement Disorder Fatigue Gait Disturbance Jaundice Nausea Speech Disorder Tremor 22-Feb-2006 08:20 AM Page: 1989 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/15/04ISR Number: 4319556-2Report Type:Expedited (15-DaCompany Report #2004015892 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatinine Literature Lithium (Lithium) PS Initial or Prolonged Increased Health Risperidoe Other Blood Sodium Increased Professional (Risperidone) SS Cerebral Atrophy Enalapril Maleate Confusional State (Enalapril Maleate) C Dehydration Valproic Acid Gait Disturbance (Valproic Acid) C Lethargy Trazodone Nephrogenic Diabetes (Trazodone) C Insipidus Pilocarpine (Pilocarpine) C Iron (Iron) C Calcium (Calcium) C Phenylpropanolamine W/Guaifenesin (Guaifenesin) C Date:03/16/04ISR Number: 4318950-3Report Type:Expedited (15-DaCompany Report #2004-113531-NL Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alanine Aminotransferase Foreign Mirtazapine PS ORAL 15 MG/30 Increased Health MG/45 MG/60 Aspartate Professional MG/45 MG Aminotransferase Other Risperidone SS ORAL 2 MG/1 MG Increased Hepatic Enzyme Increased Date:03/16/04ISR Number: 4318970-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040204759 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lower Respiratory Tract Foreign Rieperdal Consta Infection Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:03/16/04ISR Number: 4318973-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040302018 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Risperdal Consta Initial or Prolonged Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR INTRA-MUSCULA R Date:03/16/04ISR Number: 4318974-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040205470 Age:69 YR Gender:Female I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:20 AM Page: 1990 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Bipolar Disorder Foreign Risperdal Consta Cardiac Failure Acute Health (Risperidone Decreased Activity Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Fatigue WEEK, Regressive Behaviour INTRA-MUSCULA R Taxilan (Perazine) C Ergenyl Chrono (Ergenyl Chrono) C Tiapridex (Tiapride Hydrochloride) C Adumbran (Oxazepam) C Aldactone (Spironolactone) C Unat (Torasemide) C Date:03/16/04ISR Number: 4318980-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040301730 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Risperidone) PS Professional Date:03/16/04ISR Number: 4318981-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040301721 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Risperdal Initial or Prolonged Health (Risperidone) PS ORAL SEE IMAGE Other Professional Flunitrazepam (Flunitrazepam) C Thioridazine Hydrochloride (Thioridazine Hydrochloride) C Date:03/16/04ISR Number: 4319610-5Report Type:Expedited (15-DaCompany Report #2004-113538-NL Age:56 YR Gender:Female I/FU:I Outcome PT Hospitalization - Bladder Disorder Initial or Prolonged Blood Pressure Diastolic Increased Blood Pressure Systolic Increased Dysuria Electromyogram Abnormal Heart Rate Increased Hyperhidrosis Pelvic Floor Muscle Weakness Sensation Of Pressure Urinary Retention White Blood Cell Count 22-Feb-2006 08:20 AM Page: 1991 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Health Mirtazapine PS ORAL 60 MG/45 MG/ Professional 60 MG 30 DAY Risperidone SS ORAL 2 MG/3 MG/ 4 MG 5 DAY Lorazepam SS ORAL Reboxetine SS ORAL 4 MG 3 WK Date:03/16/04ISR Number: 4319942-0Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040206104 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal Initial or Prolonged Cardiomegaly Health (Risperidone) Dyspnoea Professional Unspecified PS 8 MG, IN 1 Hypotension Other DAY Hypothermia Overdose Oxygen Saturation Decreased Respiratory Rate Increased Rhonchi Somnolence Suicide Attempt Transfusion-Related Acute Lung Injury Date:03/16/04ISR Number: 4319944-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040301520 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar I Disorder Foreign Risperdal Initial or Prolonged Drug Interaction Health (Risperidone) Hallucination, Auditory Professional Unspecified PS 1 MG, IN 1 Psychotic Disorder DAY Nardil (Phenelzine Sulfate) Tablets SS ORAL 60 MG, IN 1 DAY, ORAL Date:03/17/04ISR Number: 4318933-3Report Type:Direct Company Report #CTU 214543 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Clonus Risperidone 0.25 Mg PS ORAL PO BID Intervention to Hyperreflexia STARTED Prevent Permanent Hypertonia BEFORE 3/1/04 Impairment/Damage Muscle Spasticity UNTIL 3/8 Neuroleptic Malignant Haloperidol 5 Mg SS INTRAMUSCULAR ONE TIME IM Syndrome Valprolic Acid C Tardive Dyskinesia Venlapaxine C Tamsulosin C Furosemide C Kcl C Sorbitol C 22-Feb-2006 08:20 AM Page: 1992 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/04ISR Number: 4319820-7Report Type:Expedited (15-DaCompany Report #2004-BP-01620BP (0) Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Aggrenox Capsules Initial or Prolonged Foot Amputation (Asasantin /Gfr/) PS ORAL PO Tremor Risperdol SS 0.5 MG, X 2 Ulcer Depakote (Valproate Semisodiuim SS SEE IMAGE Prilosec (Omeprazole) C Zoloft C Avandia C Date:03/17/04ISR Number: 4320001-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040100069 Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Exelon(Rivastigmine Tartrate C Colchicine(Colchicin e) C Lorazepam (Lorazepam) C Darvocet (Propacet) C Avapro (Irbesartan) C Lasix (Furosemide) C Lasix (Furosemide) C Niacin (Nicotinic Acid) C Date:03/17/04ISR Number: 4320006-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040203245 Age:86 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiopulmonary Failure Consumer Risperdal Health (Risperidone) Professional Unspecified PS Date:03/17/04ISR Number: 4320096-5Report Type:Expedited (15-DaCompany Report #2004199992US Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Study Celebrex (Celecoxib) Hospitalization - Cerebral Haemorrhage Consumer Capsule PS ORAL QD, ORAL Initial or Prolonged Coma Health Risperdal Headache Professional (Risperidone) SS Psychotic Disorder Transient Ischaemic Attack 22-Feb-2006 08:20 AM Page: 1993 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/04ISR Number: 4320135-1Report Type:Expedited (15-DaCompany Report #HQWYE618308MAR04 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Efexor (Venlafaxine Initial or Prolonged Phosphokinase Increased Professional Hydrochloride, Other Drug Interaction Tablet) PS ORAL 150 MG 1X PER Lip Dry 1 DAY, ORAL Mucosal Dryness Lithiofor (Lithium, Parkinsonism ) SS ORAL 990 MG 1X PER Seborrhoea 1 DAY; ORAL Sedation Risperdal Skin Turgor Decreased (Risperidone) SS ORAL 0.5 MG 1X PER 1 DAY; ORAL Risperdal (Risperidone) SS UNKNOWN 0.25 MG 2X PER 1 DAY; UNKNOWN Temesta (Lorazepam, Unspec) SS ORAL 0.5 MG 1X PER 1 DAY; ORAL Zyprexa (Olanzapine) SS ORAL 2.5 MG 1X PER 1 DAY; ORAL 60 DAY Zyprexa (Olanzapine) SS ORAL 7.5 MG 1X PER 1 DAY; ORAL 2 DAY Zyprexa (Olanzapine) SS ORAL 2.5 MG 1X PER 1 DAY; ORAL Pantozol (Pantoprazole) C Panadol (Paracetamol) C Date:03/17/04ISR Number: 4320219-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040301993 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Foreign Risperdal Blood Urine Present Health (Risperidone) PS ORAL 4 MG, IN 1 Cardiac Failure Professional DAY, ORAL Depressed Level Of Biperiden Consciousness Hydrochloride Diarrhoea (Biperiden Hypotension Hydrochloride) C Immunosuppression Flunitrazepam Septic Shock (Flunitrazepam) C Vomiting Estazolam (Estazolam) C Promethazine Hydrochloride (Promethazine Hydrochloride) C Chlorpromazine Tannate (Chloropromazine) C 22-Feb-2006 08:20 AM Page: 1994 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/17/04ISR Number: 4320220-4Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20040301610 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Deep Vein Thrombosis Foreign Risperdal Factor V Leiden Mutation Health (Risperidone) Prothrombin Level Professional Tablets PS ORAL 2 G, IN 1 Abnormal DAY, ORAL Pyrexia Akineton (Biperiden Hydrochloride) Tablets C Seresta (Oxazepam) Tablets C Haldol (Haloperidol) Solution C Amoxiciline + Clavulanic Acid (Amoxi-Clavulanico) C Aspegic (Acetylsalicylate Lysine) Tablets C Date:03/17/04ISR Number: 4320319-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031105519 Age:95 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Health (Risperidone Professional Solution PS ORAL 1 MG/ML, 2 IN 1 DAY, ORAL; 2 IN 1 DAY, ORAL Cylimorph (Injection), Cyclimorph Burroughs C Date:03/19/04ISR Number: 4322028-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040103679 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Risperdal Congestive Health (Risperidone) Professional Tablets PS ORAL 1 IN 1 DAY ORAL Date:03/19/04ISR Number: 4322145-7Report Type:Expedited (15-DaCompany Report #HQWYE739911MAR04 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Consumer Effexor Xr Hallucination, Auditory (Venlafaxine Suicidal Ideation Hydrochloride, Capsule Extended Release) PS ORAL 300 MG 1X PER 1 DAY, ORAL Risperdal (Risperidone, ) SS Zyprexa (Olanzapine) C 22-Feb-2006 08:20 AM Page: 1995 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/04ISR Number: 4322319-5Report Type:Expedited (15-DaCompany Report #K200400319 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Altace Capsules Initial or Prolonged Convulsion Health (Ramipril) Capsule, Disturbance In Attention Professional 1.25mg PS ORAL ORAL Transient Ischaemic Other Topalgic "Houde" Attack (Tramadol Hydrochloride) SS ORAL ORAL Aricept (Donepezil Hydrochloride) Tablet SS ORAL ORAL Risperdal (Risperidone) Tablet, 1mg SS ORAL 1 MG, QD, ORAL Levothyrox (Levothyroxine Sodium) Tablet C Date:03/19/04ISR Number: 4322678-3Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040201902 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Risperdal Consta Increased Health (Risperidone) Depression Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Mutism Company WEEK, Refusal Of Treatment By Representative INTRAMUSCULAR Patient Haldol Decanoate Tardive Dyskinesia (Haloperidol Treatment Noncompliance Decanoate) Injection SS Mirtazepine (Mirtazapine) Unspecified SS ORAL 30 MG, IN 1 DAY, ORAL Valproate (Valproate Sodium) C Atorvastatin C Benztropine (Benzatropine Mesilate) C Date:03/19/04ISR Number: 4322689-8Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20040301610 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Chills Foreign Risperdal Coagulopathy Health (Risperidone) Deep Vein Thrombosis Professional Tablets PS ORAL 2 MG, IN 1 Factor V Leiden Mutation DAY, ORAL Prothrombin Level Akineton (Tablets) Abnormal Biperiden Pyrexia Hydrochloride) C Seresta (Tablets) Oxazepam C Haldol (Solution) C Amoxicilline + Clavulanic Acid 22-Feb-2006 08:20 AM Page: 1996 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Amoxi-Clavulanico) C Aspegic (Acetylsalicylate Lysine) Tablets C Date:03/19/04ISR Number: 4322692-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040302018 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Risperdal Consta Initial or Prolonged Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR INTRA-MUSCULA R Date:03/22/04ISR Number: 4322870-8Report Type:Expedited (15-DaCompany Report #2004-113538-NL Age:56 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bladder Disorder Health Mirtazapine PS ORAL SEE IMAGE 30 DAY Initial or Prolonged Dysuria Professional Risperidone SS ORAL SEE IMAGE 5 DAY Hyperhidrosis Lorazepam SS ORAL MG Urinary Retention Reboxetine SS ORAL 4 MG 3 WK Date:03/22/04ISR Number: 4323146-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040302828 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 2 IN 1 DAY, ORAL Date:03/22/04ISR Number: 4323333-6Report Type:Expedited (15-DaCompany Report #S04-GER-01088-01 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Foreign Cipramil (Citalopram Initial or Prolonged Fear Health Hydrobromide) PS ORAL 20 MG QD PO Oropharyngeal Spasm Professional Risperdal Suffocation Feeling Other (Risperidone) SS ORAL 2 MG QD PO Tongue Spasm Date:03/22/04ISR Number: 4324644-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040303538 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Foreign Risperdal Initial or Prolonged Fall Health (Risperidone) Other Ileus Paralytic Professional Unspecified PS ORAL SEE IMAGE Megacolon Trihexyphenidyl Pubic Rami Fracture Hydrochloride Sedation (Trihexyphenidyl Hydrochloride) C Pantethine (Pantethine) C Magnesium Oxide (Magnesium Oxide) C 22-Feb-2006 08:20 AM Page: 1997 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dimeticone (Dimeticone) C Sucralfate (Sucralfate) C Dipyridamole (Dipyridamole) C Flunitrazepam (Flunitrazepam) C Famotiidine (Famotidine) C Mosapride Citrate (Mosapride Citrate) C Intravenous Fluids (Parenteral) C Date:03/22/04ISR Number: 4324645-2Report Type:Expedited (15-DaCompany Report #APCDSS2002000319 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Pulmonary Oedema Foreign Risperidone Initial or Prolonged Alanine Aminotransferase Literature (Risperidone) Increased Health Tablets PS ORAL ORAL Aspartate Professional Biperiden Aminotransferase Hydrochloride Increased (Biperiden Blood Calcium Decreased Hydrochloride) C Blood Chloride Decreased Blood Glucose Increased Blood Lactate Dehydrogenase Increased Blood Magnesium Increased Blood Ph Decreased Blood Potassium Increased Chromaturia Circulatory Collapse Contusion Dehydration Disseminated Intravascular Coagulation Haematocrit Increased Haemoglobin Increased Hypothermia Loss Of Consciousness Monoplegia Oedema Renal Failure Acute Rhabdomyolysis White Blood Cell Count Increased Wound Date:03/22/04ISR Number: 4324647-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040302620 Age:84 YR Gender:Female I/FU:I Outcome PT Death Agitation Life-Threatening Dementia General Physical Health Deterioration 22-Feb-2006 08:20 AM Page: 1998 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pain Pneumonia Transient Ischaemic Report Source Product Role Manufacturer Route Dose Duration Attack Foreign Risperdal Consumer (Risperidone) Unspecified PS 0.5 MG, 2 IN 1 DAY Date:03/22/04ISR Number: 4324851-7Report Type:Expedited (15-DaCompany Report #DSA_24074_2004 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Tavor PS ORAL 1.5 MG QD PO Initial or Prolonged Bipolar Disorder Health Akineton Retard SS ORAL 4 MG QD PO Depression Professional Cipramil SS ORAL 40 MG QD PO Intentional Self-Injury Other Sulfamethoxazole Mania W/Trimethoprim SS ORAL 960 MG QD PO Restlessness Risperdal SS ORAL 5 MG QD PO Risperdal SS ORAL 4 MG QD PO Risperdal SS ORAL 3 MG QD PO Date:03/22/04ISR Number: 4325005-0Report Type:Expedited (15-DaCompany Report #DSA_24069_2004 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Tavor PS ORAL VAR PRN PO Initial or Prolonged Restlessness Health Edronax SS ORAL 4 MG QD PO Urinary Retention Professional Remergil SS ORAL 60 MG QD PO White Blood Cell Count Other Remergil SS ORAL 45 MG QD PO Increased Remergil SS ORAL 60 MG QD PO Risperdal SS ORAL 4 MG QD PO Risperdal SS ORAL 3 MG QD PO Risperdal SS ORAL 2 MG QD PO Date:03/23/04ISR Number: 4322108-1Report Type:Expedited (15-DaCompany Report #AT-GLAXOSMITHKLINE-B0326557A Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Paroxetine PS Glaxosmithkline ORAL Initial or Prolonged Drug Level Increased Risperdal SS ORAL Electrocardiogram Qt Depakine C ORAL 1000MG per Prolonged day Dominal C ORAL 46 DAY Kemadrin C Glaxosmithkline ORAL Pantoloc C ORAL Isoptin C ORAL 60MG per day 22 DAY Esucos C ORAL 25MG per day 16 DAY Date:03/23/04ISR Number: 4323642-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040104306 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cyanosis Foreign Risperdal Other Dyspnoea Health (Risperidone) Dystonia Professional Tablets PS ORAL 2 MG, 1 IN 1 Laryngospasm DAY, ORAL Oculogyration Haldol (Haloperidol) 22-Feb-2006 08:20 AM Page: 1999 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Injection C Date:03/23/04ISR Number: 4323661-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040204759 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lower Respiratory Tract Foreign Risperdal Consta Infection Health (Risperidone) Malaise Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:03/23/04ISR Number: 4323745-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031202796 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Risperdal Foreign Body Aspiration Health (Risperidone) Injury Asphyxiation Professional Unspecified PS ORAL 2 MG, IN 1 Mental Impairment DAY, ORAL; 6 Polydipsia MG, IN 1 DAY, Pulmonary Oedema ORAL Vomiting Brotizolam Water Intoxication (Brotizolam) C Weight Increased Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Flunitrazepam (Flunitrazepam) C Levomepromazine Maleate (Levomepromazine Maleate) C Lithium Carbonate (Lithium Carbonate) C Date:03/23/04ISR Number: 4323747-4Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20040301731 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspartate Foreign Risperdal Aminotransferase Health (Risperidone) Increased Professional Tablets PS ORAL 6 MG, IN 1 Blood Creatine DAY, ORAL Phosphokinase Increased Nozinan Blood Lactate (Levomepromazine) Dehydrogenase Increased Tablets C Neck Pain Apodorm (Nitrazepam) Pain Tablets C Date:03/23/04ISR Number: 4323748-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040302620 Age:84 YR Gender:Female I/FU:F Outcome PT Death Agitation Life-Threatening Condition Aggravated 22-Feb-2006 08:20 AM Page: 2000 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report General Physical Health Deterioration Pain Report Source Product Role Manufacturer Route Dose Duration Pneumonia Foreign Risperdal Consumer (Risperidone) Unspecified PS 0.5 MG, 2 IN 1 DAY Date:03/23/04ISR Number: 4323749-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040301733 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Risperdal Initial or Prolonged Health (Risperidone) Professional Unspecified PS Date:03/23/04ISR Number: 4323750-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040302352 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Guillain-Barre Syndrome Foreign Risperdal Hospitalization - Pneumonia Health (Risperidone) Initial or Prolonged Upper Respiratory Tract Professional Unspecified PS ORAL 0.5 MG, IN 1 Disability Infection DAY, ORAL Ritalin (Methylphenidate Hydrochloride) C Date:03/23/04ISR Number: 4323956-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040304146 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal Drug Interaction Health (Risperidone) Mental Disorder Professional Unspecified PS ORAL 2 MG, IN 1 Thrombocytopenia DAY, ORAL Trihexyphenidyl Hydrochloride SS ORAL 4 MG, IN 1 DAY, ORAL Propiverine Hydrochloride (Propiverine Hydrochloride) SS ORAL 20 MG, IN 1 DAY, ORAL Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Sulpiride (Sulpiride) C Lormetazepam (Lormetazepam) C 22-Feb-2006 08:20 AM Page: 2001 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/04ISR Number: 4324482-9Report Type:Expedited (15-DaCompany Report #03P-163-0237218-00 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gait Disturbance Health Depakote (Divalproex Initial or Prolonged Hypomania Professional Sodium) (Divalproex Movement Disorder Company Sodium) PS ORAL 1750 MG, 2 IN Myalgia Representative 1 D, PER Oedema Peripheral ORAL; 1000 Tremor MG, 2 IN 1 D, PER ORAL; Tolterodine L-Tartrate SS 2 IN 1 D Risperidone SS ORAL 3 MG, 1 IN 1 D, PER ORAL Clonazepam C Benzatropine Mesilate C Date:03/23/04ISR Number: 4325019-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040303467 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Heart Rate Decreased Health Risperdal Professional (Risperidone) Company Tablets PS ORAL ORAL Representative Paxil (Paroxetine Hydrochloride) C Date:03/23/04ISR Number: 4325073-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040303438 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Consumer Risperdal (Risperidone) Tablets PS ORAL ORAL Date:03/24/04ISR Number: 4325361-3Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20040303982 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cleft Lip And Palate Foreign Risperdal Convulsion Health (Risperidone) Drug Exposure During Professional Tablets PS ORAL 6 MG, IN 1 Pregnancy DAY; ORAL Neonatal Disorder Imovane (Zopiclone) Pregnancy Tablets SS AS NECESSARY Vertebral Injury Vival (Diazepam) Tablets SS ORAL Insulininsulatard (Injection) Insulininjection C Isophane C 22-Feb-2006 08:20 AM Page: 2002 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/04ISR Number: 4325619-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040302960 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemorrhage Foreign Risperdal Consta Neoplasm Malignant Health (Risperidone) Tonsillar Disorder Professional Microspheres PS INTRAMUSCULAR INTRA-MUSCULA Ulcer R Date:03/24/04ISR Number: 4325624-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030901132 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chest Pain Foreign Risperidone Consta Hospitalization - Conjunctival Haemorrhage Health (Risperidone) Initial or Prolonged Dizziness Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Epistaxis WEEK, Gingival Bleeding INTRA-MUSCULA Haemoptysis R Haemorrhoidal Haemorrhage Nausea Thrombocytopenic Purpura Date:03/24/04ISR Number: 4325628-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040301730 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Risperidone) PS ORAL 4 MG, IN 1 Professional DAY, ORAL Date:03/24/04ISR Number: 4325634-4Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20040301740 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Cleft Lip Foreign Risperdal Cleft Palate Health (Risperidone) Convulsion Professional Tablets PS INTRA-UTERINE 6 MG, Drug Exposure During INTRAUTERINE Pregnancy Imovane (Zopiclone) Drug Interaction Tablets SS INTRA-UTERINE INTRA-UTERNIN Maternal Drugs Affecting E Foetus Vival (Diazepam) Vertebral Injury Tablets SS INTRA-UTERINE INTRA-UTERNIN E Insulin (Injection) Insulin C Date:03/24/04ISR Number: 4326192-0Report Type:Expedited (15-DaCompany Report #04P-087-0252899-00 Age:13 YR Gender:Female I/FU:I Outcome PT Hospitalization - C-Reactive Protein Initial or Prolonged Increased Drug Eruption Generalised Oedema Hepatic Function Abnormal White Blood Cell Count 22-Feb-2006 08:20 AM Page: 2003 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Report Source Product Role Manufacturer Route Dose Duration Foreign Akineton (Biperiden) PS ORAL 2 MG, 1 IN 1 Health D, PER ORAL Professional Tegretol (Carbamazepine) SS ORAL 600 MG, 1 IN 1 D, ORAL Risperidone SS ORAL 2 MG, 1 IN 1 D, ORAL Date:03/24/04ISR Number: 4327886-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040103732 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Risperdal Cardiac Disorder Professional (Risperidone) Delusion Unspecified PS 3 MG, IN 1 Psychotic Disorder DAY, Reminyl (Galantamine) C Celexa (Citalopram Hydrobromide) C Xanax (Alprazolam) C Date:03/25/04ISR Number: 4323058-7Report Type:Expedited (15-DaCompany Report #200411062FR Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Lovenox PS Aventis Initial or Prolonged Increased Pharmaceuticals Inc. SUBCUTANEOUS Aspartate Risperdal SS ORAL Aminotransferase Rovamycine C Increased Rocephine C Blood Lactate Tegretol - Slow Dehydrogenase Increased Release C Cytolytic Hepatitis Mopral C Gamma-Glutamyltransferase Increased Hepatitis Cholestatic Date:03/25/04ISR Number: 4327833-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040303294 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Risperidal Consta Schizophrenia Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Other WEEKS, INTRA-MUSCULA R Risperidone (Risperidone) Unspecified SS ORAL 6 MG, IN 1 DAY, ORAL Lustral (Sertraline Hydrochloride) Unknown C 22-Feb-2006 08:20 AM Page: 2004 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote (Valproate Semisodium) Unknown C Date:03/25/04ISR Number: 4327852-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040304428 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aneurysm Foreign Risperdal Initial or Prolonged Drug Interaction Health (Risperidone) Subarachnoid Haemorrhage Professional Unspecified PS ORAL 1 MG, IN 1 DAY, ORAL Aspirin (Acetylsalicylic Acid) Unspecified SS ORAL 1 DOSE(S), IN 1 DAY, ORAL Brotizolam (Brotizolam) Unspecified C Date:03/25/04ISR Number: 4327885-1Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040203501 Age:93 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bile Duct Obstruction Foreign Risperdal Gallbladder Disorder Health (Risperidone) PS 1.5 MG, IN 1 Hepatitis Professional DAY Hepatocellular Damage Lanoxin-Pg (Digoxin) Hepatomegaly Tablets C Lymphopenia Nitrolingual Spray (Glyceryl Trinitrate) Spray C Ikoprel (Nicorandil) C Didrocal (Didronel Pmo "Norwich Eaton") Tablets C Plavix (Clopidogrel Sulfate) C Gtn Patch (Glyceryl Trinitrate) Patch C Betaloc (Metoprolol Tartrate) Tablets C Losec (Omeprazole) C Multi-Vitamin (Multivitamins) Tablets C Viscotears (Carbomer) Opthalmic C Date:03/25/04ISR Number: 4327887-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040302112 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Pollakiuria Foreign Risperdal Urinary Incontinence Health (Risperidone) PS ORAL IN 1 DAY, Professional ORAL Fuoxetine (Fluoxetine) C 22-Feb-2006 08:20 AM Page: 2005 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/04ISR Number: 4327889-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040103672 Age:40 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Consumer Risperdal Psychotic Disorder Health (Risperidone) Victim Of Crime Professional Unspecified PS ORAL ORAL Date:03/25/04ISR Number: 4327891-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040204784 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Risperdal Initial or Prolonged Fall Health (Risperidone) PS ORAL SEE IMAGE, Professional ORAL Trimetazidine (Tablets) Trimetazidine C Aricept (Donepezil Hydrochloride) C Stilnox (Zolpidem) C Date:03/25/04ISR Number: 4327898-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040303794 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leukopenia Foreign Risperdal Pneumonia Health (Risperidone) PS ORAL 2 MG, IN 1 Professional DAY, ORAL Sodium Valproate (Valproate Sodium) C Tiapride Hydrochloride (Tiapride Hydrochloride) C Flunitrazepam (Flunitrazepam) C Estazolam (Estazolam) C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:03/25/04ISR Number: 4327900-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040303039 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Enuresis Foreign Risperdal Health (Risperidone) PS ORAL 1 MG, IN 1 Professional DAY, ORAL Paroxetine (Paroxetine) C 22-Feb-2006 08:20 AM Page: 2006 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/04ISR Number: 4328007-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031204106 Age:69 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Death Consumer Risperdal Cerebrovascular Accident Health (Risperidone) PS ORAL ORAL Myocardial Infarction Professional Date:03/25/04ISR Number: 4328018-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040204785 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Risperdal Other Regurgitation Of Food Professional (Risperidone) Tablets PS ORAL ORAL Date:03/25/04ISR Number: 4328019-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040303735 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL Date:03/25/04ISR Number: 4328022-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040303872 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG ORAL Date:03/29/04ISR Number: 4329852-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031203402 Age:42 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Breast Abscess Foreign Risperdal Galactorrhoea Health (Risperidone) Hyperprolactinaemia Professional Tablets PS ORAL SEE IMAGE Date:03/29/04ISR Number: 4329854-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040301453 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Risperdal Other Anaemia Health (Risperidone) Anxiety Professional Unspecified PS ORAL SEE IMAGE Bone Marrow Depression Nifedipine Drug Interaction (Nifedipine) Insomnia Unspecified SS ORAL 40 MG, IN 1 Irritability DAY, ORAL Leukopenia Furosemide Staphylococcal Infection (Furosemide) Unspecified SS ORAL 40 MG, IN 1 DAY, ORAL Spironolactone (Spironolactone) 22-Feb-2006 08:20 AM Page: 2007 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unspecified SS ORAL 50 MG, IN 1 DAY, ORAL Aminophylline (Aminophylline) Unspecified SS INTRAVENOUS DRIP 500 MG, IN 1 DAY, INTRAVENOUS DRIP Teicoplanin (Teicoplanin) Unspecified SS INTRAVENOUS DRIP 400 MG, IN 1 DAY, INTRAVENOUS DRIP Flunitrazepam (Flunitrazepam) SS ORAL 1 MG, IN 1 DAY, ORAL Bromhexine Hydrochloride (Bromhexine Hydrochloride) C Ambroxal Hydrochloride (Ambroxal Hydrochloride) C Proteins, Aminoacids And Preparations (All Other Therapeutic Products) C Panthenol (Panthenol) C Magnesium Oxide (Magnesium Oxide) C Sodium Picosulfate (Sodium Picosulfate) C Date:03/29/04ISR Number: 4329856-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040303579 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Disorder Foreign Risperdal Venous Thrombosis Health (Risperidone) Professional Unspecified PS ORAL ORAL Company Representative Date:03/29/04ISR Number: 4329877-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040303269 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Enterocolitis Foreign Risperdal Initial or Prolonged Haemorrhagic Health (Risperidone) Professional Unspecified PS ORAL IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 2008 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/04ISR Number: 4329879-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040304722 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Hyperhidrosis Health (Risperidone) Serotonin Syndrome Professional Unspecified PS ORAL SEE IMAGE Paroxetine Hydrochloride Hydrate (Paroxetine) Unspecified SS ORAL 20 MG, IN 1 DAY, ORAL Lithium Carbonate (Lithium Carbonate) C Flunitrazepam (Flunitrazepam) C Levomepromazine (Levomepromazine) C Date:03/29/04ISR Number: 4329880-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040303693 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Risperdal Second Degree Health (Risperidone) Bradycardia Professional Solution PS ORAL 4 MG, 3 IN 1 Drug Interaction DAY, ORAL Hypotension Risperdal Consta (Risperidone) Microspheres SS Deroxat (Paroxetine Hydrochloride) C Lysanxia (Prazepam) C Duphalac (Lactulose) C Date:03/29/04ISR Number: 4329922-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040300548 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytosis Foreign Risperdal Consta Consumer (Risperidone) Microspheres PS INTRAMUSCULAR SEE IMAGE Zoloft (Sertraline Hydrochloride) Tablets C Trevilor (Venlafaxine Hydrochloride) C Date:03/29/04ISR Number: 4331391-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040304498 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, 2 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 2009 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/04ISR Number: 4331455-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040304626 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 0.25 MG, 1 IN 1 DAY, ORAL Date:03/29/04ISR Number: 4331456-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040304628 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL 0.5 MG, ORAL Date:03/29/04ISR Number: 4331459-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040304656 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Consumer Risperdal Initial or Prolonged Gastrointestinal Disorder (Risperidone) Injection Site Reaction Tablets PS ORAL 0.5 MG, 1 IN Loss Of Consciousness 1 DAY, ORAL Myocardial Infarction Sepsis Date:03/29/04ISR Number: 4331461-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040304601 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Risperdal Initial or Prolonged Diabetic Ulcer (Risperidone) Toe Amputation Unspecified PS Tremor Aggrenox (Asasantin) Capsules SS ORAL 2 IN 1 DAY, ORAL Depakote (Valproate Semisodium) SS Prilosec (Omeprazole) C Zoloft (Sertraline Hydrochloride) C Avandia (Rosiglitazone Maleate) C Date:03/29/04ISR Number: 4331462-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040304613 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 2010 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/04ISR Number: 4331463-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040304515 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Study Risperidone Initial or Prolonged Gallbladder Disorder Health (Risperidone) Headache Professional Unspecified PS 1 TABLET; 1 Hepatitis B TABLETS; 2 Hepatomegaly TABLET Vomiting Olanzapine (Olanzapine) SS 1 TABLET; 1 TABLET; 2 TABLETS Quetiapine (Quetiapine) SS 1 TABLET; 1 TABLET; 2 TABLETS Ziprasidone (Ziprasidone) Tablets SS 1 TABLET; 1 TABLET; 2 TABLET Perphenazine (Perphenazine) SS ONE TABLET; 1 TABLETS; 2 TABLETS Date:03/29/04ISR Number: 4331465-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040304617 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Risperdal Professional (Risperidone) Company Tablets PS ORAL 1 MG, IN 1 Representative DAY, ORAL Date:03/30/04ISR Number: 4332547-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040305774 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Foreign Risperdal Initial or Prolonged Paranoia Health (Risperidone) Psychotic Disorder Professional Tablets PS ORAL ORAL Suicide Attempt Aripiprazole Suspiciousness (Aripiprazole) SS ORAL 15 MG, 1 IN 1 Urinary Incontinence DAY, ORAL Vomiting Acetaminophen (Paracetamol) SS Date:03/30/04ISR Number: 4332548-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040304274 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Balance Disorder Foreign Risperdal Transient Ischaemic Health (Risperidone) Attack Professional Unspecified PS ORAL 0.5 MG, ORAL Donepezil (Donepezil) C 22-Feb-2006 08:20 AM Page: 2011 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/30/04ISR Number: 4332779-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040304445 Age:72 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Balance Disorder Foreign Risperdal Hospitalization - Confusional State Health (Risperidone) Initial or Prolonged Renal Failure Acute Professional Unspecified PS ORAL 8 MG, ORAL Clopixol (Zuclopenthixol Decanoate) C Procyclidine C Penicillin V (Phenoxymethylpenici llin) C Haloperidol C Omeprazole C Date:03/30/04ISR Number: 4332920-0Report Type:Expedited (15-DaCompany Report #NSADSS2002008155 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL ORAL Date:03/30/04ISR Number: 4332923-6Report Type:Expedited (15-DaCompany Report #NSADSS2003024729 Age:88 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL Date:03/30/04ISR Number: 4333084-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040301560 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Foreign Risperdal Consta Hospitalization - Electrocardiogram Health (Risperidone) Initial or Prolonged Abnormal Professional Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN Other Electrocardiogram Qt 2 WEEK, Corrected Interval INTRA-MUSCULA Prolonged R Epistaxis Risperdal (Risperidone) (Unspecified) SS ORAL 7 MG, ORAL Carbimazol (Carbimazole) C Date:03/30/04ISR Number: 4333244-8Report Type:Expedited (15-DaCompany Report #04P-163-0254095-00 Age:67 YR Gender:Male I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Cardiac Disorder Cerebrovascular Accident Coronary Artery Surgery Dementia 22-Feb-2006 08:20 AM Page: 2012 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Foot Amputation Transient Ischaemic Attack Report Source Product Role Manufacturer Route Dose Duration Tremor Consumer Depakote (Divalproex Ulcer Other Sodium) (Divalproex Sodium) PS Asasantin SS 25/200 MG TWICE A DAY Risperidone SS Omeprazole C Sertraline Hydrochloride C Rosiglitazone Maleate C Date:03/31/04ISR Number: 4331145-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040301200 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colon Cancer Health Risperdal Professional (Risperidone) Tablets PS 0.5 - 1.0 MG TWICE DAILY Date:03/31/04ISR Number: 4332123-XReport Type:Expedited (15-DaCompany Report #IL-JNJFOC-20040304888 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Foreign Risperdal Health (Risperidone) Professional Unspecified PS 2-3MG/D Date:03/31/04ISR Number: 4332125-3Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20040304866 Age:89 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Risperdal Initial or Prolonged Consciousness Health (Risperidone) Professional Unspecified PS ORAL 1 MG, 1 IN 1 DAY, ORAL Allopurinol (Allopurinol) C Lansoprazole (Lansoprazole) C Calcium (Calcium) C Clotiapine (Clotiapine) C Date:04/01/04ISR Number: 4329174-8Report Type:Expedited (15-DaCompany Report #200413573GDDC Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Metronidazole PS Aventis Dyspepsia Pharmaceuticals Inc. ORAL dose: UNK Psychotic Disorder Lansoprazole SS ORAL dose: UNK Thinking Abnormal Clarithromycin SS ORAL dose: UNK Risperidone SS ORAL 22-Feb-2006 08:20 AM Page: 2013 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/04ISR Number: 4330281-4Report Type:Direct Company Report #CTU 215763 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Risperidone Tablet Intervention to 6mg Jannsen PS Jannsen ORAL 6MG PO ORAL Prevent Permanent Impairment/Damage Date:04/01/04ISR Number: 4332367-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040305726 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Toxic Epidermal Foreign Risperdal Necrolysis Health (Risperidone) Professional Unspecified PS ORAL ORAL Psychotropic Agents (Antipsychotics) C Vegetamin (Vegetamin) C Date:04/01/04ISR Number: 4332368-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040304428 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apallic Syndrome Foreign Risperdal Hospitalization - Cerebrovascular Disorder Health (Risperidone) Initial or Prolonged Dehydration Professional Unspecified PS ORAL 1 MG, IN 1 Disability Delirium DAY, ORAL Depressed Level Of Aspirin Consciousness (Acetylsalicylic Diet Refusal Acid) Unspecified SS ORAL 100 MG, IN 1 Disorientation DAY, ORAL Drug Interaction Brotizolam Fall (Brotizolam) Head Banging Unspecified SS ORAL 0.25 MG, IN 1 Impaired Self-Care DAY, ORAL Persecutory Delusion "Di" (All Other Poriomania Therapeutic Subarachnoid Haemorrhage Products) C Haloperidol (Haloperidol) C Date:04/01/04ISR Number: 4332369-0Report Type:Expedited (15-DaCompany Report #AR-JNJFOC-20040306077 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Murder Foreign Risperdal Consta Initial or Prolonged Health (Risperidone) Professional Micropheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R 22-Feb-2006 08:20 AM Page: 2014 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/04ISR Number: 4333217-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202825 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aortic Valve Incompetence Study Risperidone Initial or Prolonged Blood Creatine Health (Risperidone) PS ORAL ORAL Phosphokinase Mb Professional Olanzapine Increased (Olanzapine) SS ORAL ORAL Cerebral Atrophy Quetiapine Electrocardiogram Q Waves (Quetiapine) SS ORAL ORAL Fall Ziprasidone Hypertension (Ziprasidone) SS ORAL ORAL Mobility Decreased Perphenazine ( Myoglobin Blood Increased Perphenazine) SS ORAL ORAL Proteinuria Lorazepam Qrs Axis Abnormal (Lorazepam) C Ventricular Extrasystoles Date:04/01/04ISR Number: 4333219-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040105361 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Risperdal Consta Corrected Interval Professional (Risperidone) Prolonged Company Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Electrocardiogram Qt Representative WEEK, Prolonged INTRAMUSCULAR Risperdal (Risperidone) SS ORAL SEE IMAGE ORAL Zyprexa (Olanzapine) Tablets SS ORAL 30 MG, 1 IN 1 DAY,ORAL Prolixin (Fluphenazine Hydrochloride) SS ORAL 2.5 MG, 2 IN 1 DAY, ORAL Zoloft (Sertraline Hydrochloride) C Date:04/01/04ISR Number: 4333259-XReport Type:Expedited (15-DaCompany Report #2004AP00927 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Literature Bupivacaine PS INTRATHECAL 12 MG IT Intervention to Heart Rate Increased Health Preservative Free Prevent Permanent Hypotension Professional Morphine SS INTRATHECAL 0.2 MG IT Impairment/Damage Fentanyl SS INTRATHECAL 10 UG IT Risperidone SS 2 MG HS Lithium C Date:04/01/04ISR Number: 4333305-3Report Type:Expedited (15-DaCompany Report #NSADSS2002009995 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL ORAL Synthroid 22-Feb-2006 08:20 AM Page: 2015 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Levothyroxine Sodium) C Lisinopril (Lisinopril) C Date:04/02/04ISR Number: 4333629-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040306174 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:04/02/04ISR Number: 4333632-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040306060 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Insulin-Dependent Professional (Risperidone) Pancreatic Insufficiency Company Unspecified PS Representative Date:04/02/04ISR Number: 4333781-6Report Type:Expedited (15-DaCompany Report #AT-JNJFOC-20040305507 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal Initial or Prolonged Phosphokinase Increased Health (Risperidone) Blood Osmolarity Professional Tablets PS ORAL 1 MG, 1 IN 1 Decreased DAY, ORAL Blood Potassium Decreased Combithyrex Forte Disorientation (Novthyral) Tablets C Hyponatraemia Dominal Forte Somnolence (Prothipendyl Hydrochloride) Tablets C Renitec (Enalapril Maleate) Tablets C Seloken Retard (Metoprolol Succinate) Tablets C Date:04/02/04ISR Number: 4333799-3Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040305038 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Risperdal Health (Risperidone) Professional Tablets PS ORAL 0.5 MG, 1 IN Company 1 DAY, ORAL Representative 22-Feb-2006 08:20 AM Page: 2016 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/02/04ISR Number: 4333800-7Report Type:Expedited (15-DaCompany Report #DK-JNJFOC-20040304836 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Risperdal Initial or Prolonged Memory Impairment Health (Risperidone) Professional Tablets PS 1/2 TABLET X 2 Akineton (Biperiden Hydrochloride) C Imovane (Zopiclone) C Hexasoptin (Verapamil) C Date:04/02/04ISR Number: 4333801-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040301733 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hemiparesis Foreign Risperdal Initial or Prolonged Health (Risperidone) Disability Professional Unspecified PS ORAL 1.5 MG, IN 1 DAY, ORAL Phenytoin (Phenytoin) C Carbamazepine Retard (Carbamazepine) C Aspirin (Acetylsalicylic Acid) C Perindopril (Perindopril) C Simvastatin (Simvastatin) C Atenolol (Atenolol) C Tildiem Retard (Diltiazem Hydrochloride) C Ranitidine (Ranitidine) C Date:04/02/04ISR Number: 4333803-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040301993 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bacterial Infection Foreign Risperdal Blood Glucose Increased Health (Risperidone) Blood Urine Present Professional Unspecified PS ORAL 4 MG, IN 1 Cardiac Failure DAY, ORAL Depressed Level Of Biperiden Consciousness Hydrochloride Diarrhoea (Biperiden Septic Shock Hydrochloride) C Vomiting Flunitrazepam (Flunitrazepam) Unspecified C Estazolam (Estrazolam) Unspecified C Promethazine Hydrochloride 22-Feb-2006 08:20 AM Page: 2017 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Promethazine Hydrochloride) Unspecified C Chlorpromazine Tannate (Chlorpromazine) Unspecified C Date:04/02/04ISR Number: 4333804-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040301721 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperdal Initial or Prolonged Malaise Health (Risperidone) Other Pancytopenia Professional Unspecified PS ORAL 2 MG, IN 1 DAY, ORAL; 3 MG, IN 1 DAY, ORAL Flunitrazepam (Flunitrazepam) Unspecified C Thioridazine Hydrochloride (Thioridazine Hydrochloride) Unspecified C Date:04/02/04ISR Number: 4333805-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040305403 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Risperdal Initial or Prolonged Asthenia Health (Risperidone) Fall Professional Solution PS 1/2 PIPETTE Suicide Attempt DAILY Insulin (Insulin) C Date:04/02/04ISR Number: 4333807-XReport Type:Expedited (15-DaCompany Report #ES-JNJFOC-20031203973 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Hypersensitivity Foreign Risperdal Dystonia Health (Risperidone) Lordosis Professional Solution PS ORAL 7.5 ML, IN 1 Pain DAY, ORAL Date:04/02/04ISR Number: 4334069-XReport Type:Expedited (15-DaCompany Report #2004194247BR Age:40 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Celecoxib Vs Placebo Multiple Drug Overdose Study (Celecoxib Vs Health Placebo) Capsule PS ORAL UNK, BID, Professional ORAL Other Comparator-Risperido ne (Risperidone) Tablet SS 2 MG, BID, UNK 22-Feb-2006 08:20 AM Page: 2018 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zopiclone C Hydrochlorothiazide C Propranolol (Propranolol) C Date:04/02/04ISR Number: 4334185-2Report Type:Expedited (15-DaCompany Report #K200400319 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Altace Initial or Prolonged Convulsion Health Capsules(Ramipril) Decreased Activity Professional Capsule, 1.25mg PS ORAL ORAL Disturbance In Attention Other Topalgic Electroencephalogram "Houde"(Tramadol Abnormal Hydrochloride) SS Houde ORAL 2U, ORAL Paraparesis Aricept(Donepezil Tremor Hydrochloride) SS ORAL 10 MG , ORAL Risperdal(Risperidon e) SS ORAL 1 MG, QD, ORAL Levothyrox (Levothyroxine Sodium) C Date:04/05/04ISR Number: 4334183-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040306558 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anger Consumer Risperdal Consta Initial or Prolonged Irritability (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN WEEK, INTRA-MUSCULA R Date:04/05/04ISR Number: 4334764-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040306168 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Tablets PS ORAL 3 MG, 2 IN 1 DAY, ORAL Date:04/05/04ISR Number: 4334853-2Report Type:Expedited (15-DaCompany Report #2004205105JP Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Solanax (Alprazolam) Hospitalization - Drug Toxicity Health Tablet PS ORAL 16 MG, Initial or Prolonged Intentional Overdose Professional SINGLE, ORAL Multiple Drug Overdose Other Lexotan (Bromazepam) SS ORAL 150 MG, Renal Impairment SINGLE, ORAL Somnolence Depas (Etizolam) SS ORAL 21 MG, Suicide Attempt SINGLE, ORAL Evamyl (Lormetazepam) SS ORAL 10 MG, 22-Feb-2006 08:20 AM Page: 2019 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report SINGLE, ORAL Risperdal (Risperidone) SS ORAL 60 MG, SINGLE, ORAL Doral(Quazepam) SS ORAL 200 MG, SINGLE, ORAL Date:04/05/04ISR Number: 4334957-4Report Type:Expedited (15-DaCompany Report #DSA_24124_2004 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bowel Sounds Abnormal Foreign Tavor PS ORAL 25 MG ONCE PO Initial or Prolonged Diarrhoea Health Tavor SS SUBLINGUAL 25 MG ONCE SL Dysarthria Professional Dominal Forte SS ORAL 2000 MG ONCE Intentional Overdose Other PO Sinus Tachycardia Ethanol SS ORAL 1 L ONCE PO Somnolence Risperdal SS ORAL 20 MG ONCE PO Date:04/05/04ISR Number: 4335043-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040305402 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Risperdal Initial or Prolonged Health (Risperidone) PS ORAL ORAL Professional Date:04/05/04ISR Number: 4335877-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031100012 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Reaction Foreign Risperdal Gait Disturbance Health (Risperidone) Glaucoma Professional Unspecified PS ORAL SEE IMAGE Graft Versus Host Disease Cyclosporin Incontinence (Ciclosporin) C Penicillin (Benzylpenicillin Sodium) C Septrin (Bactrim) C Prednisilone (Prednisolone) C Fluconazole (Fluconazole) C Alphagan (Brimonidine Tartrate) C Trusopt (Dorzolamide Hydrochloride) C Seretide Accuhaler (Seretide) C Salamol (Salbutamol Sulfate) C 22-Feb-2006 08:20 AM Page: 2020 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/06/04ISR Number: 4335395-0Report Type:Expedited (15-DaCompany Report #2004UW06116 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Conjunctivitis Other Seroquel PS Intervention to Granulocytopenia Depakote SS Prevent Permanent Neuroleptic Malignant Lithium SS Impairment/Damage Syndrome Loxitane SS Polyuria Risperdal SS Date:04/06/04ISR Number: 4335536-5Report Type:Expedited (15-DaCompany Report #2004020341 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Geodon (Ziprasidone) PS ORAL 80 MG (BID) Depression ORAL Difficulty In Walking Risperdal Dysuria (Risperidone) SS ORAL 2 MG (BID) Feeling Abnormal ORAL Headache Hypoacusis Hypoaesthesia Hypokinesia Impaired Work Ability Motor Dysfunction Nervous System Disorder Penis Disorder Tinnitus Visual Acuity Reduced Visual Disturbance Weight Increased Date:04/06/04ISR Number: 4335967-3Report Type:Expedited (15-DaCompany Report #04P-056-0254510-00 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Foreign Depakine (Depakene) Initial or Prolonged Coma Health (Sodium Dehydration Professional Valproate/Valproic Extrapyramidal Disorder Acid) (Sodium Fluid Intake Reduced Valproate/Valproic PS ORAL 500 MG, 2 IN Hypernatraemia 1 D, PER ORAL Judgement Impaired Risperidone SS ORAL 2 MG, 1 IN 1 Memory Impairment D, ORAL Myoclonus Oral Intake Reduced Renal Failure Tremor Date:04/07/04ISR Number: 4336775-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040300134 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Injury Asphyxiation Consumer Risperdal Respiratory Fume Health (Risperidone) Inhalation Disorder Professional Unspecified PS 4 MG, IN 1 DAY 22-Feb-2006 08:20 AM Page: 2021 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/04ISR Number: 4336784-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040302828 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 2 IN 1 DAY, ORAL Tylenol (Paracetamol) C Norvasc (Amlodipine Besilate) C Date:04/07/04ISR Number: 4336788-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040306597 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Health Risperdal Initial or Prolonged Culture Urine Positive Professional (Risperidone) Hypothermia Tablets PS ORAL 1.5 MG, 2 IN Klebsiella Infection 1 DAY, ORAL Proteus Infection Synthroid Respiratory Failure (Levothyroxine Sinus Bradycardia Sodium) C Neurontin (Gabapentin) C Isoniazid (Isoniazid) C Vitamin B6 (Pyridoxine Hydrochloride) C Minoxidil (Minoxidil) C Hydrochlorothyazide (Hydrochlorothiazide ) C Date:04/07/04ISR Number: 4336789-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040400588 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS Professional Date:04/07/04ISR Number: 4336806-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040200315 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Consta Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR 25 MG, Representative INTRAMUSCULAR Risperdal (Risperidone) Tablets SS INTRAMUSCULAR Omeprazole (Omeprazole) C Bio-Selenium + Zinc 22-Feb-2006 08:20 AM Page: 2022 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Selenium Sulfide) C Date:04/07/04ISR Number: 4337953-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040306013 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Risperdal Initial or Prolonged Hyperthermia Malignant Health (Risperidone) Hypertonia Professional Tablets PS ORAL 2 MG, IN 1 Rhabdomyolysis DAY, ORAL Meprobamate C Fluvoxamine C Movicol (Nulytely) C Kardegic (Acetylsalicylic Lysine) C Date:04/07/04ISR Number: 4337954-8Report Type:Expedited (15-DaCompany Report #AT-JNJFOC-20040305788 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Hyponatraemia Health (Risperidone) Urine Osmolarity Professional Unspecified PS ORAL 0.5 MG, 2 IN Decreased 1 DAY, ORAL Vomiting Psychogenic Moduretic (Moduretic) Tablets SS ORAL 1 DOSE (S), 1 IN 1 DAY, ORAL Dominal Forte (Tablets) Prothipendyl Hydrochloride C Epilan-D-Gerot (Phenytoin) Tablets C Ergotop (Nicergoline) Film Coated Tablet C Date:04/07/04ISR Number: 4337960-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040304437 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Health Risperdal Depressed Level Of Professional (Risperidone) Consciousness Tablets PS ORAL 3 MG, IN 1 Drug Exposure During DAY, ORAL; Pregnancy SEE IMAGE Drug Withdrawal Syndrome Neonatal Neonatal Disorder Pregnancy Premature Separation Of Placenta Salivary Hypersecretion Somnolence Neonatal 22-Feb-2006 08:20 AM Page: 2023 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/04ISR Number: 4337963-9Report Type:Expedited (15-DaCompany Report #NZ-JNJFOC-20040400299 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal Health (Risperidone) Professional Unspecified PS Date:04/07/04ISR Number: 4337966-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040306030 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal Drug Interaction Health (Risperidone) Dyspepsia Professional Unspecified PS ORAL 500 UG, 1 IN Psychotic Disorder 1 DAY, ORAL Lansoprazole (Lansoprazole) SS ORAL 2 IN 1 DAY, ORAL Clarithromycin (Clarithromycin) SS 2 IN 1 DAY Metronidazoel (Metronidazole) SS 2 IN 1 DAY Date:04/07/04ISR Number: 4338070-1Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20040400582 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal Consta Drug Level Decreased Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:04/07/04ISR Number: 4338267-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040203289 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abdominal Strangulated Foreign Risperdal Hospitalization - Hernia Health (Risperidone) Initial or Prolonged Brain Death Professional Unspecified PS Clostridium Colitis Gallbladder Operation General Physical Health Deterioration Hypotension Hypotonia Meningitis Staphylococcal Mydriasis Post Procedural Complication Pulmonary Oedema Small Intestine Gangrene Staphylococcal Infection Staphylococcal Sepsis Umbilical Hernia 22-Feb-2006 08:20 AM Page: 2024 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/04ISR Number: 4338270-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040203134 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Steatosis Foreign Risperdal Hepatosplenomegaly Health (Risperidone) Professional Unspecified PS ORAL 4 MG, IN 1 DAY, ORAL Bio Selenium + Zinc (Selenium Sulfide) C Date:04/07/04ISR Number: 4338272-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031203560 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Caesarean Section Foreign Risperdal Initial or Prolonged Complications Of Maternal Health (Risperidone) Exposure To Therapeutic Professional Tablets PS ORAL 1 MG, 2 IN 1 Drugs Company DAY, ORAL Escherichia Sepsis Representative Clamoxyl Hypothermia (Amoxicillin Premature Labour Trihydrate) C Urinary Tract Infection Date:04/07/04ISR Number: 4338274-8Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040206104 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Foreign Risperdal Initial or Prolonged Cardiomegaly Health (Risperidone) Chest X-Ray Abnormal Professional Unspecified PS 8 MG, IN 1 Dyspnoea DAY Hypotension Hypothermia Overdose Oxygen Saturation Decreased Pco2 Increased Po2 Decreased Respiratory Rate Increased Rhonchi Somnolence Suicide Attempt Date:04/07/04ISR Number: 4338277-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040203898 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Enuresis Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 1 MG, 1 IN 1 DAY, ORAL Paroxetine (Paroxetine) C 22-Feb-2006 08:20 AM Page: 2025 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/04ISR Number: 4338281-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040303269 Age:13 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Risperdal Initial or Prolonged Diarrhoea Health (Risperidone) Enterocolitis Professional Unspecified PS ORAL , IN 1 DAY, Haemorrhagic ORAL Rectal Haemorrhage Orap (Pimozide) Unspecified SS ORAL 2 MG, IN 1 DAY, ORAL Seretide (Seretide) C Ventoline (Salbutamol) C Date:04/07/04ISR Number: 4338291-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040302620 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Foreign Risperdal Life-Threatening Aphagia Consumer (Risperidone) Hospitalization - Candidiasis Health Unspecified PS SEE IMAGE Initial or Prolonged Cerebrovascular Accident Professional Fall General Physical Health Deterioration Pain Pneumonia Somnolence Subdural Haemorrhage Transient Ischaemic Attack Date:04/07/04ISR Number: 4338335-3Report Type:Expedited (15-DaCompany Report #04P-056-0247493-00 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Anorexia Foreign Depakote (Divalproex Intervention to Asthenia Health Sodium) (Divalproex Prevent Permanent Cholestasis Professional Sodium) PS ORAL 500 MG, 2 IN Impairment/Damage Cytolytic Hepatitis Company 1 D, ORAL Jaundice Representative Anethole Trithione SS ORAL 150 MG, 1 IN Lung Infection 1 D, PER ORAL Pyrexia Cyamemazine SS ORAL 110 DOSAGE FORMS, PER ORAL Risperidone SS ORAL 6 MG, 1 IN 1 D, PER ORAL Amoxicillin Trihydrate SS ORAL 1 DOSAGE FORMS, 3 IN 1 D, PER ORAL Paracetamol C 22-Feb-2006 08:20 AM Page: 2026 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/04ISR Number: 4337857-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040206106 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Condition Aggravated Foreign Risperdal Consta Drug Interaction Health (Risperidone) Pyromania Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Schizophrenia WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Unspecified SS ORAL 6 MG, 1 IN 1 DAY, ORAL Lustral (Sertraline Hydrochloride) C Depakote (Valproate Semisodium) C ... C Date:04/08/04ISR Number: 4337859-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040303271 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Foreign Risperdal Increased Health (Risperidone) Myocardial Infarction Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Sudden Death WEEK, INTRA-MUSCULA R Haldol Decanoate (Haloperidol Decanoate) Injection SS INTRAMUSCULAR 100 MG, INTRA-MUSCULA R Quetiapine C Date:04/09/04ISR Number: 4338557-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031203345 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Foreign Risperdal Increased Health (Risperidone) PS ORAL 2 MG, 1 IN 1 Blood Triglycerides Professional DAY, ORAL Increased Levomepromazine Diabetes Mellitus Maleate Inadequate Control (Levomepromazine Glycosylated Haemoglobin Maleate) SS ORAL 25 MG, IN 1 Increased DAY, ORAL Hepatic Steatosis Paroxetine Hyperglycaemia Hydrochloride Polydipsia Hydrate SS ORAL 50 MG, IN 1 Urine Ketone Body Present DAY, ORAL Weight Increased Paroxetine Hydrochloride Hydrate (Paroxetine) Unspecified SS ORAL 20 MG, IN 1 DAY, ORAL Promethazine Hydrochloride SS 22-Feb-2006 08:20 AM Page: 2027 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Triazolam (Triazolam) C Lomerizine Hydrochloride (All Other Therapeutic Products) C Famotidine (Famotidine) C Date:04/09/04ISR Number: 4338738-7Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040400849 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Emotional Disorder Foreign Risperdal Health (Risperidone) PS ORAL 1 MG, IN 1 Professional DAY, ORAL Date:04/09/04ISR Number: 4338739-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040400312 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Increased Foreign Risperdal Leukopenia Health (Risperidone) PS ORAL 6 MG, ORAL Neutropenia Professional Zopiclone (Zopiclone) C Diazepam (Diazepam) C Date:04/09/04ISR Number: 4338740-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040306316 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Respiratory Depression Foreign Risperdal Health (Risperidone) PS Professional Date:04/09/04ISR Number: 4338741-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040306318 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Respiratory Depression Foreign Risperdal Health (Risperidone) PS Professional Date:04/09/04ISR Number: 4338742-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040302112 Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Enuresis Foreign Risperdal Pollakiuria Health (Risperidone) PS ORAL IN 1 DAY, Professional ORAL Fluoxetine (Fluoxetine) C 22-Feb-2006 08:20 AM Page: 2028 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/04ISR Number: 4338743-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040303579 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Risperdal Eye Haemorrhage Health (Risperidone) PS ORAL 2 MG, IN 1 Retinal Vein Thrombosis Professional DAY, ORAL Company Belok Zoc Mite Representative (Tablets) Metoprolol Succinate C Date:04/09/04ISR Number: 4338804-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040400845 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Rispedral Health (Risperidone) Professional Unspecified PS 2 MG, IN 1 DAY Halomonth (Haloperidol Decanoate) Injection SS Date:04/09/04ISR Number: 4342137-1Report Type:Periodic Company Report #03P-163-0237507-00 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Depakote (Divalproex Professional Sodium) (Divalproex Other Sodium) PS 1500 MG Clozapine SS ORAL 400 MG, PER ORAL Risperidone SS 4 MG, 2 IN 1 D Quetiapine SS 800 MG, 1 IN 1 D Date:04/12/04ISR Number: 4339114-3Report Type:Expedited (15-DaCompany Report #SEWYE679501APR04 Age:84 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antipsychotic Drug Level Foreign Efexor PS ORAL 150 MG 1X PER Initial or Prolonged Above Therapeutic Health 1 DAY Blood Calcium Increased Professional Lithionit (Lithium Bundle Branch Block Left Other Sulfate, ,0) SS ORAL 42 MG 1X PER Bundle Branch Block Right 1 DAY Confusional State Risperdal Urine Output Increased (Risperidone,, 0) SS ORAL 1 MG 1X PER 1 DAY Date:04/12/04ISR Number: 4339137-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040400448 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 2029 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/04ISR Number: 4339235-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040306597 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Health Risperdal Initial or Prolonged Coma Professional (Risperidone) Culture Urine Positive Tablets PS ORAL 1.5 MG, 2 IN Hypotension 1 DAY, ORAL Hypothermia Synthroid Klebsiella Infection (Levothyroxine Proteus Infection Sodium) C Respiratory Failure Neurontin Sinus Bradycardia (Gabapentin) C Isoniazid (Isoniazid) C Vitamin B6 (Pyridoxine Hydrochloride) C Minoxidil (Minoxidil) C Hydrochlorothyazide (Hydrochlorothiazide ) C Pred-40 (Prednisolone) Solution C Date:04/12/04ISR Number: 4339544-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040301513 Age:34 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Consta Neutropenia Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Company WEEK, Representative INTRA-MUSCULA R Lepticur (Tropatepine Hydrochloride) C Xanax (Alprazolam) C Date:04/12/04ISR Number: 4339546-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040400577 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Influenza Like Illness Foreign Risperdal Consta Jaundice Health (Risperidone) Oedema Peripheral Professional Microspheres PS Swelling Face Date:04/12/04ISR Number: 4339547-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030805362 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Purpura Foreign Risperdal Thrombocytopenia Health (Risperidone) Professional Solution PS Exelon (Rivastigmine 22-Feb-2006 08:20 AM Page: 2030 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tartrate) C Risordan (Isosorbide Dinitrate) C Date:04/12/04ISR Number: 4339861-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031006290 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutropenia Foreign Risperdal Health (Risperidone) PS ORAL ORAL Professional Epilin (Valproate Sodium) C Date:04/12/04ISR Number: 4339863-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031004900 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Risperidone) PS 1 MG, IN 1 Professional DAY Date:04/12/04ISR Number: 4339864-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030803985 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Risperidone) PS 3 MG, 1 IN 1 Professional DAY Date:04/12/04ISR Number: 4339866-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030801932 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Leukopenia Health (Risperidone) Other Thrombocytopenia Professional Tablets PS ORAL ORAL Tongue Neoplasm Malignant Clozapine Stage Unspecified (Clozapine) SS Date:04/12/04ISR Number: 4339867-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20030706434 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Health (Risperidone) PS ORAL 3 MG, 1 IN 1 Professional DAY, ORAL Remergil (Mirtazapine) C Date:04/12/04ISR Number: 4343470-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040401130 Age:68 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Loss Of Consciousness Foreign Risperdal Meningioma Health (Risperidone) PS ORAL 1 MG, 1 IN 1 Professional DAY, ORAL 22-Feb-2006 08:20 AM Page: 2031 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Donepezil (Donepezil) C Olanzapine (Olanzapine) C Date:04/12/04ISR Number: 4343471-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040104735 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspartate Foreign Risperdal Aminotransferase Health (Risperidone) Increased Professional Unspecified PS ORAL 1 MG, IN 1 Electrocardiogram Qt DAY, ORAL Corrected Interval Dipiperon Prolonged (Pipamperone) Gamma-Glutamyltransferase Unspecified SS ORAL 40 MG, ORAL Increased Beloc Zok (Metoprolol Succinate) Tablets SS ORAL 1 DOSE (S), IN 1 DAY, ORAL Tavor (Lorazepam) C Amineurin (Amitriptyline Hydrochloride) C Ass (Acetylsalicylic Acid) C Antihypertensive (Antihypertensives) C Zoloft (Sertraline Hydrochloride) C Omeprazole (Omeprazole) C Voltaren (Diclofenac Sodium) C Dytide H (Dyazide) C Amaryl (Glimepiride) C Date:04/12/04ISR Number: 4343473-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031101224 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Company Stangyl Representative (Trimipramine Maleate) C Date:04/13/04ISR Number: 4338102-0Report Type:Direct Company Report #CTU 216511 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Cholesterol Respedal PS ORAL 3 MG QD ORAL Intervention to Increased Prevent Permanent Hypothyroidism Impairment/Damage 22-Feb-2006 08:20 AM Page: 2032 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/13/04ISR Number: 4338262-1Report Type:Direct Company Report #CTU 216510 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Cholesterol Risperidone PS ORAL 1 MG O.D. Intervention to Increased ORAL Prevent Permanent Impairment/Damage Date:04/13/04ISR Number: 4340943-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040200183 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Automatism Foreign Risperdal Consta Initial or Prolonged Delusion Health (Risperidone) Depression Professional Microspheres PS INTRAMUSCULAR 25-37.5 MG, 1 Disease Recurrence Company IN 2 WEEK, Electroencephalogram Representative INTRA-MUSCULA Abnormal R Extrapyramidal Disorder Risperidone Hallucination, Auditory (Risperidone) C Persecutory Delusion Deroxat (Paroxetine Tremor Hydrochloride) C Viral Infection Stilnox (Zolpidem) C Vocal Cord Disorder Vocal Cord Paresis Date:04/13/04ISR Number: 4340969-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040401177 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL ORAL Professional Date:04/13/04ISR Number: 4340972-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040401620 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Temporal Arteritis Health Risperdal Initial or Prolonged Professional (Risperidone) Tablets PS ORAL 1 MG, IN 1 DAY, ORAL Date:04/13/04ISR Number: 4341013-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040401175 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 2033 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/13/04ISR Number: 4341021-7Report Type:Expedited (15-DaCompany Report #IN-JNJFOC-20040103396 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Risperidone- Blinded Initial or Prolonged Phosphatase Increased Study (Risperidone) Other Blood Bilirubin Increased Health Tablets PS ORAL 2 DOSE(S), 2 Blood Bilirubin Professional IN 1 DAY, Unconjugated Increased ORAL Blood Chloride Increased Quetiapine Diarrhoea (Quetiapine) Duodenal Ulcer Capsules SS ORAL 2 DOSE(S), 2 Eosinophilia IN 1 DAY, Haematochezia ORAL Helicobacter Infection Placebo (Placebo) Helminthic Infection Capsules SS ORAL 2 DOSE(S), 2 Hypochromic Anaemia IN 1 DAY, Jaundice ORAL Leukopenia Fefol (Capsules) Marrow Hyperplasia Fefol C Microcytic Anaemia Pain In Extremity Pallor Palpitations Stomach Discomfort Transfusion Reaction Date:04/13/04ISR Number: 4341024-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031004900 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Effect Foreign Risperdal Health (Risperidone) Professional Unspecified PS 1 MG, IN 1 DAY Date:04/14/04ISR Number: 4339174-XReport Type:Direct Company Report #CTU 216584 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Risperdal 3mg PS ORAL PO BID Intervention to Corrected Interval Prevent Permanent Prolonged Impairment/Damage Date:04/14/04ISR Number: 4339354-3Report Type:Direct Company Report #CTU 216544 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Phimosis Risperdal 2 Mg Initial or Prolonged Priapism Janssen PS Janssen ORAL 2 MG DAILY ORAL 22-Feb-2006 08:20 AM Page: 2034 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/14/04ISR Number: 4339991-6Report Type:Direct Company Report #CTU 216607 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Risperdal 2mg Bid PS ORAL 2MG PO BID Date:04/14/04ISR Number: 4340400-1Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040401478 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Foreign Risperdal Consta Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, INTRAMUSCULAR Risperdal (Risperidone) Unspecified SS 3 MG, IN 1 DAY Olanzapine (Olanzapine) C Diazepam (Diazepam) C Date:04/14/04ISR Number: 4340403-7Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20040203230 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Consta Study (Risperidone) Health Microspheres PS INTRAMUSCULAR 25 MG, 1 IN Professional 15 DAY, INTRAMUSCULAR Tertensif (Indapamide) Tablets C Dianben (Metformin Hydrochloride) C Date:04/14/04ISR Number: 4340404-9Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20040400660 Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Risperdal Consta Agitation Health (Risperidone) Alcohol Use Professional Microspheres PS 50 MG Drug Abuser Drug Effect Decreased Injury Date:04/14/04ISR Number: 4340405-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040205524 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Risperdal Initial or Prolonged Depressed Level Of Health (Risperidone) Other Consciousness Professional Tablets PS ORAL 1 MG, 1 IN 1 Electroencephalogram DAY, ORAL Abnormal Topalgic (Tramadol Epilepsy Hydrochloride) Intestinal Obstruction Unspecified SS ORAL 2 DOSE(S), IN 22-Feb-2006 08:20 AM Page: 2035 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 DAY, ORAL Aricept (Donepezil Hydrochloride) SS ORAL 10 MG, IN 1 DAY, ORAL Triatec (Ramipril) C Levothyroxine (Levothyroxine) C Date:04/14/04ISR Number: 4340448-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-2004042346 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Foreign Risperdal Palpitations Health (Risperidone) Professional Unspecified PS ORAL 6 MG, 1 IN 1 DAY, ORAL Date:04/14/04ISR Number: 4340870-9Report Type:Expedited (15-DaCompany Report #THQ2004A00334 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Helimet Drug Interaction Health (Lansoprazole, Psychotic Disorder Professional Clarithromycin, Other Metronidazole) PS ORAL UNKNOWN (2 IN 1 D) PER ORAL Risperidone (Risperidone) SS 500 MCG (500 MCG, 1 IN 1 D) Date:04/15/04ISR Number: 4341741-4Report Type:Expedited (15-DaCompany Report #AT-JNJFOC-20040305507 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal Initial or Prolonged Phosphokinase Increased Health (Risperidone) PS ORAL 1 MG, 1 IN 1 Blood Osmolarity Professional DAY, ORAL Decreased Combithyrex Forte Blood Potassium Decreased (Novothyral) C Disorientation Dominal Forte Hyponatraemia (Prothipendyl Somnolence Hydrochloride) C Renitec (Enalapril Maleate) C Seloken Retard (Metoprolol Succinate) C Date:04/15/04ISR Number: 4341747-5Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040203501 Age:91 YR Gender:Female I/FU:F Outcome PT Other Agitation Bile Duct Obstruction Escherichia Urinary Tract Infection Hepatitis 22-Feb-2006 08:20 AM Page: 2036 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatocellular Damage Hepatomegaly Lymphopenia Report Source Product Role Manufacturer Route Dose Duration Paranoia Foreign Risperdal Health (Risperidone) Professional Unspecified PS 1.5 MG, IN 1 DAY Lanoxin-Pg (Digoxin) C Nitrolingual Spray (Glyceryl Trinitrate) C SUBLINGUAL Ikorel (Nicorandil) C Didrocal (Didronel Pmo "Norw`Ich Eaton") C Plavix (Clopidogrel Sulfate) C Gtn Patch (Glyceryl Trinitrate) C Betaloc (Metoprolol Tartrate) C Losec (Omeprazole) C Multivitamin (Multivitamins) C Viscotears (Carbomer) C Triprim (Trimethoprim) C Date:04/15/04ISR Number: 4341749-9Report Type:Expedited (15-DaCompany Report #CN-JNJFOC-20040402343 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Foreign Risperdal Initial or Prolonged Discomfort Consumer (Risperidone) PS SEE IMAGE Drug Ineffective Health Artane Fall Professional (Trihexyphenidyl Lumbar Vertebral Fracture Other Hydrochloride) SS ORAL ORAL Musculoskeletal Stiffness Paralysis Tongue Disorder Vision Blurred Date:04/15/04ISR Number: 4341750-5Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20030905845 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nystagmus Foreign Risperdal Initial or Prolonged Vision Blurred Health (Risperidone) PS ORAL 4 MG, 1 IN 1 Professional DAY, ORAL Lithium (Lithium) C 22-Feb-2006 08:20 AM Page: 2037 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/04ISR Number: 4341752-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040401130 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Creutzfeldt-Jakob Disease Foreign Risperdal Meningioma Health (Risperidone) PS ORAL 1 MG, 1 IN 1 Sedation Professional DAY, ORAL Donepezil (Donepezil) C Olanzapine (Olanzapine) C Date:04/15/04ISR Number: 4341753-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040301733 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hemiparesis Foreign Risperdal Initial or Prolonged Health (Risperidone) PS ORAL 1.5 MG, IN 1 Disability Professional DAY, ORAL Phenytoin (Phenytoin) C Carbamazepine Retard (Carbamazepine) C Aspirin (Acetylsalicylic Acid) C Perindorpil (Perindopril) C Simvastatin (Simvastatin) C Atenolol (Atenolol) C Tildiem Retard (Diltiazem Hydrochloride) C Ranitidine (Ranitidine) C Isib Xl (Isosorbide Mononitrate) C Date:04/15/04ISR Number: 4341919-XReport Type:Expedited (15-DaCompany Report #138640USA Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Health Pimozide PS ORAL 2 MILLIGRAM Initial or Prolonged Gastritis Professional ORAL 1 YR Rectal Haemorrhage Risperidone SS ORAL ORAL 7 MON Weight Increased Seretide C Salbutamol C Date:04/15/04ISR Number: 4342305-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040304626 Age:96 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Consumer Risperdal Life-Threatening Pulmonary Embolism Health (Risperidone) Professional Tablets PS ORAL 0.25 MG, 1 IN 1 DAY, ORAL Monopril (Fosinopril Sodium) C 22-Feb-2006 08:20 AM Page: 2038 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/04ISR Number: 4342308-4Report Type:Expedited (15-DaCompany Report #US-JNFOC-20040303735 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Health Risperdal Hyponatraemia Professional (Risperidone) Subdural Haematoma Tablets PS ORAL ORAL Date:04/15/04ISR Number: 4342338-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040401978 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:04/15/04ISR Number: 4342342-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040401982 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL Date:04/15/04ISR Number: 4342343-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040401983 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 2 IN 1 DAY, ORAL Zoloft (Tablets) Sertraline Hydrochloride C Date:04/16/04ISR Number: 4340162-8Report Type:Direct Company Report #CTU 216761 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lactation Disorder Risperidone PS ORAL 0.5 MG PO QAM 1.5 MG PO QHS Aripiprazole C Lamotrigine C Albuterol Mdi C Date:04/16/04ISR Number: 4342449-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040402377 Age:7 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Count Decreased Health Risperdal Initial or Prolonged Professional (Risperidone) PS ORAL 2 MG ORAL Zoloft (Sertraline Hydrochloride) C 22-Feb-2006 08:20 AM Page: 2039 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/16/04ISR Number: 4342670-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040303065 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Risperdal Initial or Prolonged Asthenia Health (Risperidone) Herpes Simplex Professional Tablets PS ORAL 4 MG, IN 1 Pyrexia Company DAY, ORAL; Representative SEE IMAGE Tercian (Cyamemazine) Unspecified SS 160 MG, IN 1 DAY Lepticur (Tropatepine Hydrochloride) Unspecified SS Rivotril (Unspecified) Clozepam C Date:04/16/04ISR Number: 4343163-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040402593 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS Date:04/16/04ISR Number: 4343164-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040402742 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL 1 MG, 3 IN 1 DAY, ORAL Date:04/16/04ISR Number: 4343165-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040301881 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Carotid Artery Occlusion Health Risperdal Cerebrovascular Accident Professional (Risperidone) Sedation Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Date:04/16/04ISR Number: 4343166-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040304498 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, 2 IN 1 DAY, ORAL Klonapin (Clonazepam) C Cogentin 22-Feb-2006 08:20 AM Page: 2040 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Benzatropine Mesilate) C Date:04/16/04ISR Number: 4343167-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040103769 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Health Risperdal Phosphokinase Increased Professional (Risperidone) Drug Toxicity Unspecified PS Mental Status Changes Date:04/19/04ISR Number: 4342550-2Report Type:Direct Company Report #CTU 216922 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Distension Risperdal 25 Mg Hospitalization - Asthma Injection PS 25 MG EVERY 2 Initial or Prolonged Burn Oesophageal WEEKS Disability Chest Pain INJECTED Other Convulsion Risperdal 3 2 Mg Required Crying =Janssen /Johnson & Intervention to Dermatitis Exfoliative Johnson SS 2 MG THEN 3 Prevent Permanent Epilepsy MG DAILY Impairment/Damage Facial Palsy Fall Fatigue Flatulence Infection Loss Of Consciousness Muscle Rigidity Myalgia Nausea Nightmare Oedema Peripheral Rash Skin Disorder Skin Infection Sleep Attacks Sleep Disorder Speech Disorder Syncope Throat Irritation Vomiting Weight Increased Date:04/19/04ISR Number: 4343142-1Report Type:Expedited (15-DaCompany Report #A02200401262 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Face Oedema Health Stilnox- (Zolpidem) Initial or Prolonged Oedema Peripheral Professional - Tablet- 10 Mg PS ORAL 10 MG QD, Pericardial Effusion ORAL 1 YR Swelling Face Mianserin Hydrochloride - Tablet - SS ORAL 20 MG QD, ORAL 1 YR Zoloft - (Sertraline Hydrochloride) SS ORAL 50 MG OD, 22-Feb-2006 08:20 AM Page: 2041 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Risperdal - (Risperidone) - Tabelt - 1 Mg/Tablet - 1 Mg SS ORAL 2 MG/1 MG, ORAL 1 YR Date:04/19/04ISR Number: 4343841-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040400912 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Oedema Peripheral Health (Risperidone) Pericardial Effusion Professional Tablets PS ORAL 2 MG, 1 IN 1 Vomiting DAY, ORAL; SEE IMAGE Mianserine (Mianserin) SS ORAL 20 MG, 1 IN 1 DAY, ORAL Stilnox (Zolpidem) SS ORAL 10 MG, 1 IN 1 DAY, ORAL Zoloft (Sertraline Hydrochloride) SS ORAL 50 MG, 2 IN 1 DAY, ORAL Date:04/19/04ISR Number: 4343842-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040400990 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Risperdal Initial or Prolonged Phosphokinase Increased Health (Risperidone) Dialysis Professional Unspecified PS ORAL 0.5 MG, ORAL Muscle Disorder Benzodiazepin Muscular Weakness (Benzodiazepine Myoglobinuria Derivatives) C Oedema Renal Failure Acute Renal Injury Date:04/19/04ISR Number: 4343925-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040402851 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:04/19/04ISR Number: 4344047-2Report Type:Expedited (15-DaCompany Report #2004205105JP Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Overdose Foreign Solanax (Alprazolam) Hospitalization - Multiple Drug Overdose Health Tablet PS ORAL 16 MG, Initial or Prolonged Somnolence Professional SINGLE, ORAL Suicide Attempt Other Lexotan (Bromazepam) SS ORAL 150 MG, SINGLE, ORAL Depas (Etizolam) SS ORAL 21 MG, SINGLE, ORAL 22-Feb-2006 08:20 AM Page: 2042 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Evamyl (Lormetazepam) SS ORAL 10 MG, SINGLE, ORAL Risperdal (Risperidone) SS ORAL 60 MG, SINGLE, ORAL Doral (Quazepam) SS ORAL 200 MG, SINGLE, ORAL Date:04/19/04ISR Number: 4344431-7Report Type:Expedited (15-DaCompany Report #EMADSS2003004284 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperdal Initial or Prolonged General Nutrition Health (Risperidone) Other Disorder Professional Solution PS ORAL 6 MG, IN 1 Hepatic Cirrhosis Other DAY, ORAL Hepatic Fibrosis Cipramil (Citalopram Hepatic Steatosis Hydrobromide)Tablets SS ORAL 1 DOSE(S), IN Hepatitis Acute 1 DAY, ORAL Hepatomegaly Multi-Vitamins Psychotic Disorder (Multivitamins) C Centrum Vitamins (Centrum) C Date:04/19/04ISR Number: 4344435-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040401509 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Risperdal Consta Initial or Prolonged Hallucination, Visual Health (Risperidone) Tachypnoea Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 14 DAY, INTRA-MUSCULA R Risperdal (Risperidone) C Date:04/19/04ISR Number: 4344671-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040400992 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Foreign Risperdal Initial or Prolonged Drug Interaction Health (Risperidone) Dysstasia Professional Tablets PS ORAL 5 MG, 1 IN 1 Hyperhidrosis DAY, ORAL Loss Of Consciousness Xatral (Alfuzosin) SS ORAL 2.5 MG, 1 IN Pallor 1 DAY, ORAL Rhabdomyolysis Parkinane Lp Syncope (Trihexyphenidyl Tremor Hydrochloride) SS ORAL 5 MG, 1 IN 1 Vertigo DAY, ORAL Vision Blurred Lexomil (Bromazepam) C Stilnox (Zolpidem) C Deroxat (Paroxetine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 2043 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/19/04ISR Number: 4344685-7Report Type:Expedited (15-DaCompany Report #2004023431 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Atarax (Tablet) Health (Hydroxyzine Professional Hydrochloride) PS ORAL 25 MG (DAILY), ORAL Risperidone (Risperidone) SS ORAL 2 MG (DAILY), ORAL Date:04/20/04ISR Number: 4342329-1Report Type:Direct Company Report #CTU 216931 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Lithium PS ORAL 450 MG PO TID Initial or Prolonged Dysphagia Resperdone SS ORAL 1.5 MG PO QHS Required Tremor Intervention to Vision Blurred Prevent Permanent Impairment/Damage Date:04/20/04ISR Number: 4344270-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040203333 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delayed Recovery From Foreign Risperdal Anaesthesia Health (Risperidone) Drug Clearance Decreased Professional Unspecified PS ORAL 2 MG, 2 IN 1 Metabolic Disorder DAY, ORAL Psychotic Disorder General Anaesthetic (Anaesthetics, General) C Citalopram (Citalopram) C Date:04/20/04ISR Number: 4344272-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040401808 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Foreign Risperdal Pancytopenia Health (Risperidone) Professional Unspecified PS ORAL 2 MG, ORAL Sodium Valproate (Valproate Sodium) SS ORAL 1500 MG, ORAL Citalopram (Citalopram) C Date:04/20/04ISR Number: 4344278-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040401610 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL SEE IMAGE L-Thyroxin (Levothyroxine 22-Feb-2006 08:20 AM Page: 2044 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Date:04/20/04ISR Number: 4344287-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040203266 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) Aspartate Professional Tablets PS ORAL 3 MG, 1 IN 1 Aminotransferase DAY, ORAL Increased Zoloft (Sertraline Blood Bilirubin Increased Hydrochloride) C Cryptogenic Organizing Valium (Diazepam) C Pneumonia Aotal (Acamprosate) C Pulmonary Embolism Mepronizine (Mepronizine) C Depakote (Valproate Semisodium) C Date:04/20/04ISR Number: 4344292-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040300009 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alcoholism Foreign Risperdal Consta Delusion Health (Risperidone) Dependence Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Disease Recurrence Company WEEK, Hallucination Representative INTRA-MUSCULA R Valium (Diazepam) C Date:04/20/04ISR Number: 4345142-4Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20040400582 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Level Below Foreign Risperdal Consta Therapeutic Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal Consta (Risperidone) Microspheres SS Date:04/20/04ISR Number: 4345144-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040401816 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Foreign Risperdal Consta Blood Creatine Health (Risperidone) Phosphokinase Increased Professional Microsphere PS INTRAMUSCULAR INTRA-MUSCULA Circulatory Collapse R Hypotonia 22-Feb-2006 08:20 AM Page: 2045 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/20/04ISR Number: 4346035-9Report Type:Expedited (15-DaCompany Report #A02200401238 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Health Xatral- (Alfuzosin) Initial or Prolonged Dizziness Professional - Tablet Pr- 2.5 Mg PS ORAL 12.5 MG OD, Fall ORAL Hyperhidrosis Rispedal Hypotension (Risperidone) SS ORAL ORAL 22 DAY Loss Of Consciousness Parkinane - Malaise (Trihexyphenidyl Pallor Hydrochloride) - Rhabdomyolysis Tablet Pr - 5 Mg SS ORAL 5 MG OD, ORAL Vertigo Lexomil (Bromazepam) C Vision Blurred Stilnox (Zolpidem) C Deroxat (Paroxetine Hdyrochloride) C Date:04/21/04ISR Number: 4343872-1Report Type:Direct Company Report #CTU 217061 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Status Changes Diazepam PS 10 MG BID 20 Initial or Prolonged MG Q HS Trazodone SS ORAL 250 MG PO Q HS Risperidone 5 Mg Q Hs SS 5 MG QHS Lithium 600 Qhs And 300 Mg Q Am SS 600 QHS & 300 MG QAM Date:04/21/04ISR Number: 4345390-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040301993 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bacterial Infection Foreign Risperdal Life-Threatening Blood Glucose Increased Health (Risperdal) Blood Urine Present Professional Unspecified PS ORAL 4 MG, IN 1 Cardiac Failure DAY, ORAL Depressed Level Of Biperidan Consciousness Hydrochloride Diarrhoea (Biperidan Hypotension Hydrochloride) C Immunodeficiency Flunitrazepam Pyrexia (Flunitrazepam) Septic Shock Unspecified C Vomiting Estazolam (Estazolam) Unspecified C Promethazine Hydrochloride (Promethazine Hydrochloride) Unspecified C Chlorpromazine Tannate (Chlorpromazine Tannate) Unspecified C 22-Feb-2006 08:20 AM Page: 2046 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/04ISR Number: 4347057-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040303794 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Foreign Risperdal Leukopenia Health (Risperidone) Neutropenia Professional Unspecified PS ORAL 2 MG, IN 1 Pneumonia DAY, ORAL Sodium Valproate (Valporate Sodium) Unspecified SS ORAL 400 MG, 1 IN 1 DAY, ORAL Tiapride Hydrochloride (Tiapride Hydrochloride) Unspecified SS ORAL 100 MG, 1 IN 1 DAY, ORAL Flunitrazepam (Flunitrazepam) Unspecified C Estazolam (Estazolam) Unspecified C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) Unspecified C Biperiden Hydrochloride (Biperiden Hydrochloride) Unspecified C Date:04/22/04ISR Number: 4347636-4Report Type:Expedited (15-DaCompany Report #2004024568 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Count Decreased Health Zoloft (Sertraline) PS UNKNOWN, Initial or Prolonged Professional UNKNOWN Other Risperdal (Risperidone) SS UNKNOWN, UNKNOWN Unspecified Blood Pressure Medication (Antihypertensives) C Unspecified Diabetic Medication (Anti-Diabetics) C Date:04/22/04ISR Number: 4347680-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040403330 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone ) Professional Tablets PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 2047 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/22/04ISR Number: 4347683-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040403201 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL Date:04/22/04ISR Number: 4347686-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040403192 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:04/22/04ISR Number: 4347688-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040403188 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericarditis Health Risperdal Initial or Prolonged Pneumothorax Professional (Risperidone) Company Tablets PS ORAL 0.1 MG, 1 IN Representative 1 DAY, ORAL Zoloft (Sertraline Hydrochloride) C Strattera (All Other Therapeutic Products) C Date:04/22/04ISR Number: 4347692-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040402943 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL Antipsychotics (Antipsychotics) C Date:04/22/04ISR Number: 4347729-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040404099 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, ORAL Date:04/22/04ISR Number: 4347732-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040403339 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Unspecified PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 2048 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/04ISR Number: 4345951-1Report Type:Direct Company Report #CTU 217238 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Risperdal 1 Mg PS ORAL .5 TO 1.0 MG Intervention to Non-Insulin-Dependent 1X DAYILY Prevent Permanent Hypothyroidism ORAL Impairment/Damage Insulin Resistance Tenex C Pituitary-Dependent Buspar C Cushing'S Syndrome Zoloft C Weight Increased Prozac C Weight Loss Poor . C Serzone C Date:04/23/04ISR Number: 4348652-9Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20031100329 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Foreign Risperdal Complications Of Maternal Health (Risperidone) Exposure To Therapeutic Professional Unspecified PS ORAL 4 MG, IN 1 Drugs DAY, ORAL Drug Exposure Via Breast Zoloft (Sertraline Milk Hydrochloride) C Drug Withdrawal Syndrome Aurorix Neonatal (Moclobemide) C Maternal Drugs Affecting Marcain (Bupivacaine Foetus Hydrochloride) C Fentanyl (Fentanyl) C Date:04/26/04ISR Number: 4346898-7Report Type:Expedited (15-DaCompany Report #AUS/95/00010/LEX Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Clozaril PS Novartis Sector: Delirium Pharma 12 - 750 Extradural Haematoma mg/day Haematoma Valproate Sodium SS 20 g, Incoherent ONCE/SINGLE Multiple Drug Overdose Clozaril SS Novartis Sector: Road Traffic Accident Pharma 7.7 g, Suicide Attempt ONCE/SINGLE Clozaril SS Novartis Sector: Pharma ORAL 200 mg, QD 1440 MIN Risperidone SS 14 mg, ONCE/SINGLE Date:04/26/04ISR Number: 4349358-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040303693 Age:72 YR Gender:Female I/FU:F Outcome PT Death Atrioventricular Block Second Degree Balance Disorder Bradycardia Drug Interaction Electrocardiogram P Wave Abnormal Hypotension 22-Feb-2006 08:20 AM Page: 2049 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypothermia Incoherent Lung Disorder Report Source Product Role Manufacturer Route Dose Duration Overdose Foreign Risperdal Septic Shock Health (Risperidone) Sinoatrial Block Professional Solution PS ORAL SEE IMAGE, Staphylococcal ORAL Bacteraemia Risperdal Consta Ventricular Extrasystoles (Risperidone) Microspheres SS INTRAMUSCULAR 50 MG, 1 IN 14 DAY, INTRA-MUSCULA R Deroxat (Paroxetine Hydrochloride) C Lysanxia (Prazepam) C Duphalac (Lactulose) C Date:04/26/04ISR Number: 4349409-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040305062 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Risperdal Initial or Prolonged Phosphatase Increased Health (Risperidone) Constipation Professional Tablets PS ORAL SEE IMAGE Headache Company Tiapridal (Tiapride) C Nausea Representative Stomach Discomfort Vomiting Date:04/26/04ISR Number: 4349410-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040403929 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pneumonia Foreign Risperdal Rhabdomyolysis Health (Risperidone) Professional Unspecified PS ORAL 5 MG, IN 1 DAY, ORAL Date:04/26/04ISR Number: 4349411-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040303579 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Risperdal Eye Haemorrhage Health (Risperidone) Ocular Vascular Disorder Professional Unspecified PS ORAL 2 MG, IN 1 Venous Thrombosis Company DAY, ORAL Representative Belok Zoc Mite (Metoprolol Succinate) SS Date:04/26/04ISR Number: 4349412-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040104735 Age:75 YR Gender:Female I/FU:F Outcome PT Other Aspartate Aminotransferase 22-Feb-2006 08:20 AM Page: 2050 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Electrocardiogram Qt Corrected Interval Prolonged Report Source Product Role Manufacturer Route Dose Duration Gamma-Glutamyltransferase Foreign Risperdal Increased Health (Risperidone) Professional Unspecified PS ORAL 1 MG, IN 1 DAY, ORAL Dipiperon (Pipamperone) Unspecified SS ORAL 40 MG, ORAL Beloc Zok (Metoprolol Succinate) Tablets SS ORAL 1 DOSE (S), IN 1 DAY, ORAL Cipramil (Citalopram Hydrobromide) C Tavor (Lorazepam) C Amineurin (Amitriptyline Hydrochloride) C Ass (Acetylsalicylic Acid) C Antihypertensive (Antihypertensives) C Zoloft (Sertraline Hydrochloride) C Omeprazole (Omeprazole) C Voltaren (Diclofenac Sodium) C Dytide H (Dyazide) C Amaryl (Glimepiride) C Date:04/26/04ISR Number: 4349414-9Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20040400660 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Risperdal Consta Initial or Prolonged Aggression Health (Risperidone) Other Agitation Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Alcohol Poisoning WEEK, Injury INTRA-MUSCULA R Date:04/26/04ISR Number: 4349415-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040403261 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Foreign Risperdal Consta Prolactinoma Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR INTRA-MUSCULA Company R Representative 22-Feb-2006 08:20 AM Page: 2051 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/04ISR Number: 4349416-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040203972 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Foreign Risperdal Consta Neutropenia Study (Risperidone) Health Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Professional WEEK, INTRA-MUSCULA R Date:04/26/04ISR Number: 4349947-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040303667 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Risperdal Consta Initial or Prolonged Depression Health (Risperidone) Extrapyramidal Disorder Professional Microspheres PS INTRAMUSCULAR 50 MG, Homicidal Ideation INTRA-MUSCULA Insomnia R : 37.5 MG, Suicidal Ideation INTRA-MUSCULA Treatment Noncompliance R Risperdal (Risperidone) Unspecified SS ORAL 8 MG , 2 IN 1 DAY, ORAL : 2 MG, 1 IN 1 DAY , ORAL Depakote (Valproate Semisodium) C Cogentin (Benzatropine Mesilate) C Date:04/26/04ISR Number: 4350168-0Report Type:Expedited (15-DaCompany Report #2004024856 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Foreign Zoloft (Sertraline) PS ORAL 150 MG Initial or Prolonged Neonatal Health (DAILY), ORAL Maternal Drugs Affecting Professional Risperidone Foetus (Rispridone) SS ORAL 0.25 MG (DAILY), ORAL Date:04/28/04ISR Number: 4349344-2Report Type:Expedited (15-DaCompany Report #PHRM2004FR01372 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Thyroid Stimulating Trileptal PS Novartis Sector: Hormone Increased Pharma ORAL 300 mg, BID Hypothyroidism Risperdal SS ORAL 8 mg daily Tercian SS 100 mg daily 22-Feb-2006 08:20 AM Page: 2052 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/04ISR Number: 4349352-1Report Type:Expedited (15-DaCompany Report #PHNU2004DE01563 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Attention Leponex / Clozaril Initial or Prolonged Drug Interaction (Clozapine) PS Novartis Sector: Drug Level Increased Pharma ORAL up to 500 Electroencephalogram mg/day Abnormal Leponex / Clozaril Grand Mal Convulsion (Clozapine) SS Novartis Sector: Pharma ORAL 350 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 300 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 250 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma up to 450 mg/day Truxal SS ORAL Unknown Truxal SS ORAL 160 mg/day Truxal SS ORAL 230 mg/day 1440 MIN Truxal SS ORAL 280 mg/day 1440 MIN Truxal SS ORAL 350 mg/day 1440 MIN Truxal SS ORAL 220 mg/day Risperdal SS ORAL 2 mg/day Risperdal SS ORAL 4 mg/day Dociton C ORAL 60 mg/day L-Thyroxin "Henning Berlin" C ORAL 125 A?g/day Date:04/28/04ISR Number: 4349363-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE01567 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Leponex / Clozaril Initial or Prolonged Consciousness (Clozapine) PS Novartis Sector: Drug Interaction Pharma ORAL 12.5 mg/day 1440 MIN Facial Bones Fracture Leponex / Clozaril Fall (Clozapine) SS Novartis Sector: Grand Mal Convulsion Pharma ORAL 25 mg/day 1440 MIN Risperdal SS 1 to 3 mg/day 5760 MIN Risperdal SS 4 mg/day 108 DAY Risperdal SS 5 mg/day 17280MIN Risperdal SS 6 mg/day Zyprexa SS 5 to 10 mg/day 28800MIN Zyprexa SS 15 mg/day 51840MIN Zyprexa SS 20 mg/day 83 DAY Zyprexa SS 10 mg/day Cipramil SS 20 mg/day 56160MIN Bronchoretard SS 350 mg/day Tavor C 3 to 4 mg/day 44640MIN Tavor C 2.5 to 0.5 mg/day 73440MIN Tavor C 2 to 1.5 mg/day 79200MIN Tavor C 1 mg/day 34560MIN Tavor C 0.5 mg/day 4320 MIN 22-Feb-2006 08:20 AM Page: 2053 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ass "Hexal" C 100 mg/day Pulmicort C 0.8 mg/day Berotec C 0.4 mg/day Date:04/28/04ISR Number: 4350530-6Report Type:Direct Company Report #CTU 217681 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Risperidone Decreased -Risperdal- 2 Mg White Blood Cell Count Janssen PS Jannsen ORAL 2 MG IN THE Decreased MOR ORAL Risperidone -Risperdal- 4 Mg Janssen SS Janssen ORAL 4 MG AT BEDTIME ORAL Haloperidone Decanoate C Benztropine C Cefuroxime C Levofloxacin C Date:04/28/04ISR Number: 4350889-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040404232 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Consumer Risperdal Health (Risperidone) PS ORAL ORAL Professional Date:04/28/04ISR Number: 4350893-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040404234 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL ORAL Professional Date:04/28/04ISR Number: 4350896-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040205559 Age:18 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Contusion Health Risperdal Foreign Body Aspiration Professional (Risperidone) PS ORAL 6 MG, 1 IN 1 Head Injury Company DAY, ORAL Hepatic Steatosis Representative Lithium (Lithium) C Depakote (Valproate Semisodium) C Benztropine (Benzatropine Mesilate) C 22-Feb-2006 08:20 AM Page: 2054 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/04ISR Number: 4351040-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202650 Age:91 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Health Risperdal Professional (Risperidone) Company Tablets PS ORAL 1 MG, ORAL Representative Date:04/28/04ISR Number: 4352354-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040403936 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Foreign Risperdal Initial or Prolonged Somnolence Health (Risperidone) Professional Tablets PS ORAL 8 MG, 1 IN 1 DAY, ORAL Tenordate (Nif-Ten "Imperial") C Lasilix 40 (Furosemide) C Modopar Lp (Madopar) C Deprenyl 5 (Selegiline) C Trivastal Lp (Piribedil) C Nootropyl (Piracetam) C Floxyfral (Fluvoxamine Maleate) C Rivotril (Clonazepam) C Date:04/28/04ISR Number: 4352358-XReport Type:Expedited (15-DaCompany Report #DK-JNJFOC-20040405479 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Complications Of Maternal Foreign Risperdal Initial or Prolonged Exposure To Therapeutic Health (Risperidone) Drugs Professional Unspecified PS INTRA-UTERINE 0.25 MG, IN 1 Drug Withdrawal Syndrome DAY, Neonatal INTRAUTERINE Maternal Drugs Affecting Zoloft (Sertraline Foetus Hydrochloride) SS INTRA-UTERINE 150 MG, 1 IN Pregnancy 24 HOUR, INTRAUTERINE Date:04/28/04ISR Number: 4352365-7Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20040203230 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Consta Study (Risperidone) Health Microspheres PS INTRAMUSCULAR 25 MG, 1 IN Professional 15 DAY, INTRAMUSCULAR Tertensif (Indapamide) C 22-Feb-2006 08:20 AM Page: 2055 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dianben (Metformin Hydrochloride) C Cusimolol (Timolol Maleate) C Pilocarpine (Pilocarpine) C Date:04/28/04ISR Number: 4352549-8Report Type:Expedited (15-DaCompany Report #2004025545 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gamma-Glutamyltransferase Foreign Atarax (Tablet) Increased Health (Hydroxyzine Hepatic Function Abnormal Professional Hydrochloride) PS ORAL ORAL Risperidone (Risperidone) SS ORAL ORAL Amisulpride (Amisulpride) C Date:04/29/04ISR Number: 4353062-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040205101 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Deep Vein Thrombosis Foreign Risperdal Consta Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Nitarazepam (Nitrazepam) C Date:04/29/04ISR Number: 4353064-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040203875 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fracture Foreign Risperdal Leukocytosis Health (Risperidone) PS ORAL 3 MG, IN 1 Nasopharyngitis Professional DAY, ORAL Levomepromazine Maleate (Levomepromazine Maleate) C Flunitrazepam (Flunitrazepam) C Date:04/29/04ISR Number: 4353454-3Report Type:Direct Company Report #CTU 217955 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Hypersensitivity Risperidone PS ORAL 2 DF DAILY Intervention to Rash Maculo-Papular PO Prevent Permanent Rash Pruritic Tegretol SS ORAL 200 MG BID PO Impairment/Damage Risperdale C 22-Feb-2006 08:20 AM Page: 2056 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/04ISR Number: 4350921-3Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-B0313893A Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Bupropion PS Glaxosmithkline ORAL Completed Suicide Risperidone SS ORAL Convulsion Sertraline SS ORAL Overdose Date:04/30/04ISR Number: 4352689-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040405381 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Date:04/30/04ISR Number: 4352690-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040405377 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 3 MG, IN 1 DAY, ORAL Fluoxetine (Fluoxetine) Capsules C Date:04/30/04ISR Number: 4352692-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040405069 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Insulin-Dependent Professional (Risperidone) Tablets PS ORAL 0.25 MG, 2 IN 1 DAY, ORAL Date:04/30/04ISR Number: 4352693-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040405058 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Unspecified PS ORAL 1 MG, 2 IN 1 DAY, ORAL Date:04/30/04ISR Number: 4353599-8Report Type:Expedited (15-DaCompany Report #2004026034 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Face Oedema Foreign Zoloft (Sertraline) PS ORAL 100 MG Initial or Prolonged Oedema Peripheral Health (DAILY), ORAL Pericardial Effusion Professional All Other Vomiting Therapeutic Products (All Other 22-Feb-2006 08:20 AM Page: 2057 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Products) SS ORAL 20 MG (DAILY), ORAL Zolpidem (Zolpidem) SS ORAL 10 MG (DAILY), ORAL Risperidone (Risperidone) SS ORAL 4 MG (FOUR TIMES DAILY), ORAL Date:04/30/04ISR Number: 4353618-9Report Type:Expedited (15-DaCompany Report #KII-2004-0009891 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Study Morphine Sulfate Initial or Prolonged Anger Health (Similar To Nda Other Blood Pressure Systolic Professional 19-516) (Morphine Increased Other Sulfate) PS ORAL ORAL Body Temperature Oxycodone Increased Hydrochloride Confusional State (Similar To Nda Delusional Perception 20-553) (Oxycodone Dysarthria Hydrochloride) SS ORAL ORAL Lethargy Benzodiazepines Medication Error Derivatives () SS ORAL ORAL Memory Impairment Carisoprodol Neologism (Carisoprodol) SS ORAL ORAL Neurological Examination Ssri () SS ORAL ORAL Abnormal Tetrahydrocannabinol Respiratory Rate (Tetrahydrocannabino Increased l) SS Serotonin Syndrome Risperdal Tachycardia (Risperidone) SS ORAL ORAL Lamictal (Lamotrigine) SS ORAL ORAL Date:04/30/04ISR Number: 4353708-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040405375 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Tablet PS ORAL 2 MG, 1 IN 1 Professional DAY, ORAL Date:04/30/04ISR Number: 4353811-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031100012 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Reaction Foreign Risperdal Excitability Health (Risperidone) Gait Disturbance Professional Unspecified PS ORAL 6 MG, 1 IN 1 Incontinence DAY, ORAL; 4 Open Angle Glaucoma MG, 1 IN 1 DAY, ORAL; 5 MG, 1 IN 1 Cyclosporin (Ciclosporin) C Penicillin (Benzylpenicillin 22-Feb-2006 08:20 AM Page: 2058 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Septrin (Bactrim) C Prednisolone (Prednisolone) C Fluconazole (Fluconazole) C Alphagan (Brimonidine Tartrate) Douche C Trusopt (Dorzolamide Hydrochloride) Drops C Seretide Accuhaler (Seretide) C Salamol (Salbutamol Sulfate) Inhalation C Date:04/30/04ISR Number: 4353812-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040404516 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Facial Bones Fracture Health (Risperidone) Fall Professional Unspecified PS 1-3 MG/DAY; 4 Grand Mal Convulsion MG; 5 MG; 6 MG Leponex (Clozapine) SS 12.5 MG; 25 MG Zyprexa (Olanzapine) SS 5-10 M G Cipramil (Citalopram Hydrobromide) SS 20 MG Bronchoretard (Theophylline) SS 350 MG Ass (Unknown) (Acetylsalicylic Acid C Pulmicort (Unknown) Budesonide C Date:04/30/04ISR Number: 4353827-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040404523 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Phlebitis Foreign Risperdal Salivary Hypersecretion Health (Risperidone) Professional Solution PS ORAL 1 MG, IN 1 Company DAY, ORAL Representative Reminyl (Galantamine) C Date:04/30/04ISR Number: 4353828-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040404518 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Supraventricular Foreign Risperdal Consta Tachycardia Health (Risperidone) Professional Microspheres PS 25 MG 22-Feb-2006 08:20 AM Page: 2059 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/30/04ISR Number: 4353890-5Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040405310 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pulmonary Fibrosis Foreign Risperdal Health (Risperidone) PS 1 MG, 1 IN 1 Professional DAY Company Representative Date:04/30/04ISR Number: 4353902-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040301993 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bacterial Infection Foreign Risperdal Life-Threatening Blood Glucose Increased Health (Risperidone) PS ORAL 4 MG, IN 1 Blood Urine Present Professional DAY, ORAL Cardiac Failure Biperiden Depressed Level Of Hydrochloride Consciousness (Biperiden Diarrhoea Hydrochloride) C Hypotension Flunitrazepam Septic Shock (Flunitrazepam) C Therapy Non-Responder Estazolam Vomiting (Estazolam) C Promethazine Hydrochloride (Prometazine Hydrochloride) C Chlorpromazine Tanante (Chlorpromazine Tannate) C Date:05/03/04ISR Number: 4351332-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040404264 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Risperdal PS OROPHARINGEAL Initial or Prolonged Lung Disorder Date:05/03/04ISR Number: 4351333-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040200986 Age: Gender:Male I/FU:I Outcome PT Death Agoraphobia Hospitalization - Arrhythmia Initial or Prolonged Blood Glucose Increased Deep Vein Thrombosis Dyspnoea Extrapyramidal Disorder Neuroleptic Malignant Syndrome Oxygen Saturation Decreased Pneumonia Pulmonary Embolism Restlessness Salivary Hypersecretion 22-Feb-2006 08:20 AM Page: 2060 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sleep Disorder Somnolence Thinking Abnormal Report Source Product Role Manufacturer Route Dose Duration Vertigo Risperdal PS OROPHARINGEAL 0-0-2 Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL 2-0-3 Metformin C OROPHARINGEAL 1-0-0 Lactulose C OROPHARINGEAL Euglucon C OROPHARINGEAL 7-0-3.5 Date:05/03/04ISR Number: 4351334-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040200170 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Risperdal PS OROPHARINGEAL 1 MON Blood Bilirubin Abnormal Lorazepam C UNKNOWN Blood Creatine Clozapine I UNKNOWN Phosphokinase Increased Blood Urea Decreased Confusional State Drug Interaction Hallucination Date:05/03/04ISR Number: 4351335-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040305062 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Risperdal PS OROPHARINGEAL Initial or Prolonged Blood Alkaline Risperdal SS OROPHARINGEAL Phosphatase Increased Risperdal SS OROPHARINGEAL Constipation Risperdal SS OROPHARINGEAL Headache Risperdal SS OROPHARINGEAL Nausea Tiapridal C Vomiting Tiapridal C Date:05/03/04ISR Number: 4351336-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040405996 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Risperdal PS OROPHARINGEAL Initial or Prolonged Atrial Fibrillation Capotril C Blood Creatine Phosphokinase Increased Blood Creatinine Increased Blood Urea Increased Coma Lethargy Liver Function Test Abnormal Muscle Rigidity Myoglobin Blood Increased Troponin Increased 22-Feb-2006 08:20 AM Page: 2061 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/04ISR Number: 4351338-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040404508 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Reminyl PS OROPHARINGEAL Hospitalization - Cerebrovascular Accident Risperdal SS OROPHARINGEAL Initial or Prolonged Coma Sotalex SS OROPHARINGEAL Hyponatraemia Date:05/03/04ISR Number: 4351339-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040405943 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Electrocardiogram Qt Risperdal SS OROPHARINGEAL Prolonged Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Lepticur C Valium C Date:05/03/04ISR Number: 4351757-XReport Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-B0313871A Age:43 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Drug Reaction Paxil PS Glaxosmithkline ORAL Other Bradycardia Wellbutrin SS Glaxosmithkline ORAL Cardiac Arrest Risperidone SS UNKNOWN Death Clonazepam SS UNKNOWN Eye Movement Disorder Mental Impairment Muscle Rigidity Pyrexia Date:05/03/04ISR Number: 4353879-6Report Type:Expedited (15-DaCompany Report #2004205105JP Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Foreign Solanax(Alprazolam) Hospitalization - Drug Toxicity Health Tablet PS ORAL 16.8 MG, Initial or Prolonged Multiple Drug Overdose Professional SINGLE, ORAL Renal Impairment Other Lexotan (Bromazapem) SS ORAL 150 MG, Somnolence SINGLE, ORAL Suicide Attempt Depas(Etizolam) SS ORAL 21 MG, SINGLE, ORAL Evamyl (Lormetazepam) SS ORAL 10 MG, SINGLE, ORAL Risperdal (Risperidone) SS ORAL 60 MG, SINGLE, ORAL Doral (Quazepam) SS ORAL 200 MG, SINGLE, ORAL 22-Feb-2006 08:20 AM Page: 2062 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/04ISR Number: 4354062-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040404761 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Risperdal Hypokinesia Health (Risperidone) Hypothermia Professional Unspecified PS ORAL 6 MG, IN 1 Hypothyroidism DAY, ORAL Loss Of Consciousness Biperiden Meningitis Hydrochloride Pallor (Biperiden Somnolence Hydrochloride) Subdural Hygroma Unspecified SS ORAL 6 MG, IN 1 DAY, ORAL Lithium Carbonate Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) SS ORAL 3 MG, IN 1 DAY, ORAL Stomachics And Digestives (Stomachic Mixture /Tha/) Unspecified SS ORAL 0.72 G, IN 1 DAY, ORAL Sennoside (All Other Therapeutic Products) Unspecified SS ORAL 24 MG, IN 1 DAY, ORAL Zotepine (Zotepine) Unspecified SS ORAL 150 MG, IN 1 DAY, ORAL Hydroxyzine Pamoate (Hydroxyzine Embonate) Unspecified SS ORAL 90 MG, IN 1 DAY, ORAL Sodium Valpoate (Valproate Sodium) Unspecified SS ORAL 600 MG, IN 1 DAY, ORAL Midodrine Hydrochloride (Midodrine Hydrochloride) Unspecified SS ORAL 6 MG, IN 1 DAY, ORAL Flunitrazepam (Flunitrazepam) Unspecified SS ORAL 2 MG, IN 1 DAY, ORAL Lithium Carbonate (Lithium Carbonate) Unspecified C ORAL 1.2 G, IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 2063 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/04ISR Number: 4354063-2Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20040404872 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Risperdal Initial or Prolonged Consciousness Health (Risperidone) Drug Interaction Professional Tablets PS ORAL 3 MG, IN 1 Extrapyramidal Disorder DAY, ORAL Rhabdomyolysis Loramet (Lormetazepam) Tablets SS ORAL 2 MG, IN 1 DAY, ORAL Lantanon (Mianserin Hydrochloride) SS ORAL 30 MG, IN 1 DAY, ORAL Oponaf (Lactitol) Solution SS ORAL ORAL Adiro (Acetylsalicylic Acid) C Co-Diovan (Co-Diovan) C Valsartan (Valsartan) C Date:05/03/04ISR Number: 4354075-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040403943 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Foreign Risperdal Consta Dyspnoea Health (Risperidone) Pulse Pressure Decreased Professional Microspheres PS 25 MG Chlorpromazine (Chlorpromazine) C Olanzapine (Olanzapine) C Date:05/03/04ISR Number: 4354086-3Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040203501 Age:93 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Risperdal Bile Duct Obstruction Health (Risperidone) PS ORAL 12.5 MG, 1 IN Escherichia Urinary Tract Professional 1 DAY, ORAL Infection Lanoxin-Pg (Tablets) Gallbladder Disorder Digoxin C Hepatitis Nitrolingual Spray Hepatocellular Damage (Spray) Glyceryl Lymphopenia Trinitreate C Paranoia Ikorel (Nicorandil) C Didrocal (Didronel Pmo "Norwich Eaton") Tablets C Plavix (Clopidogrel Sulfate) C Gtn Patch (Glyceryl Trinitrate) C Betaloc (Metoprolol Tartrate) C Losec (Omeprazole) C 22-Feb-2006 08:20 AM Page: 2064 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multi Vitamin (Multivitamins)Talbe ts C Viscotears (Carbomer) Opthalmic C Triprim (Trimethoprim) C Date:05/04/04ISR Number: 4352652-2Report Type:Expedited (15-DaCompany Report #DK-JNJFOC-20040304836 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Risperdal PS 1/2 tablet x Initial or Prolonged Dementia Alzheimer'S Type 2 Gait Disturbance Akineton C 3 x daily Memory Impairment Imovane C Movement Disorder Hexasoptin C Strabismus Urinary Tract Infection Enterococcal Vibration Test Abnormal Date:05/04/04ISR Number: 4355319-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040405996 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Risperdal Initial or Prolonged Atrial Fibrillation Professional (Risperidone) Blood Creatine Tablets PS ORAL 1 MG, 2 IN 1 Phosphokinase Increased DAY, ORAL Blood Urea Increased Captopril Coma (Captopril) C Lethargy Liver Function Test Abnormal Muscle Rigidity Myoglobin Blood Increased Troponin Increased Date:05/04/04ISR Number: 4355323-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040200170 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Foreign Risperdal Confusional State Health (Risperidone) Delirium Professional Tablets PS ORAL 4MG, 1 IN 1 Drug Interaction DAY, ORAL Hallucination Clozapine (Clozapine) Unknown SS 62.5 MG, 1 IN 1 DAY, Lorazepam (Lorazepam) C 22-Feb-2006 08:20 AM Page: 2065 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/04/04ISR Number: 4355327-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040404264 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Risperdal Initial or Prolonged Hyperthermia Health (Risperidone) Lung Disorder Professional Tablets PS ORAL 6 MG, IN 1 Somnolence DAY, ORAL Date:05/04/04ISR Number: 4355367-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040405943 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Consta Initial or Prolonged Electrocardiogram Qt Health (Risperidone) Prolonged Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Unspecified SS ORAL 6 MG, IN 1 DAY, ORAL; 8 MG, IN 1 DAY, ORAL; 10 MG, IN 1 Lepticur (Tropatepine Hydrochloride) C Valium (Diazepam) C Date:05/04/04ISR Number: 4355369-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040404508 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Autonomic Nervous System Foreign Reminyl Hospitalization - Imbalance Health (Galantamine) Initial or Prolonged Bradycardia Professional Unspecified PS ORAL 16 MG, 1 IN 1 Cerebrovascular Accident DAY, ORAL Coma Risperdal Condition Aggravated (Risperidone) Dementia Alzheimer'S Type Unspecified SS ORAL 1 DOSE(S), Hyponatraemia IN 1 DAY, Malnutrition ORAL Sotalex (Sotalol Hydrochloride) Unknown SS ORAL 40 MG, IN 1 DAY, ORAL Date:05/04/04ISR Number: 4355393-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040200986 Age:58 YR Gender:Male I/FU:I Outcome PT Death Agoraphobia Hospitalization - Arrhythmia Initial or Prolonged Blood Creatine Phosphokinase Mb Increased Blood Glucose Increased 22-Feb-2006 08:20 AM Page: 2066 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bundle Branch Block Left Deep Vein Thrombosis Electrocardiogram Poor Report Source Product Role Manufacturer Route Dose Duration R-Wave Progression Foreign Risperdal Electrocardiogram St Health (Risperidone) Segment Depression Professional Tablets PS ORAL SEE IMAGE Electrocardiogram St . C Segment Elevation . C Electrocardiogram T Wave . C Inversion Metformin Extrapyramidal Disorder (Metformin) Tablets C Neuroleptic Malignant Lactulose Syndrome (Lactulose) Solution C Oxygen Saturation Euglocon Decreased (Glibenclamide) Palpitations Tablets C Parkinsonism Pneumonia Pulmonary Embolism Qrs Axis Abnormal Restlessness Salivary Hypersecretion Sleep Disorder Thinking Abnormal Troponin I Increased Ventricular Hypertrophy Vertigo Date:05/04/04ISR Number: 4355394-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040305062 Age:11 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Alkaline Foreign Risperdal Initial or Prolonged Phosphatase Increased Health (Risperidone) Constipation Professional Tablets PS ORAL 2 MG, IN 1 Headache Company DAY, ORAL Nausea Representative . C Stomach Discomfort . C Vomiting . C . C Tiapridal (Tiapride) C Date:05/05/04ISR Number: 4353354-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040405933 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal PS UNKNOWN Retinal Artery Occlusion Date:05/05/04ISR Number: 4353355-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040406366 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Risperdal PS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2067 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/04ISR Number: 4353356-2Report Type:Expedited (15-DaCompany Report #NZ-JNJFOC-20040500005 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Iron Increased Risperdal PS OROPHARINGEAL Start date: Therapeutic Response 4-5 years Decreased ago. Date:05/05/04ISR Number: 4353357-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040300650 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Lasix C Accupril C Aricept C Megace C Aspirin C Date:05/05/04ISR Number: 4355887-8Report Type:Expedited (15-DaCompany Report #DK-JNJFOC-20040304836 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Foreign Risperdal Initial or Prolonged Confusional State Health (Risperidone) Eye Movement Disorder Professional Tablets PS 1/2 TABLET X Gait Disturbance 2 Sensory Disturbance Akineton (Biperiden Strabismus Hydrochloride) C Urinary Tract Infection Imovane (Zopliclone) C Enterococcal Hexasoptin Visual Acuity Reduced (Verapamil) C Date:05/06/04ISR Number: 4356317-2Report Type:Expedited (15-DaCompany Report #S04-GER-01931-01 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Cipramil (Citalopram Initial or Prolonged Facial Bones Fracture Health Hydrobromide) PS 20 MG QD Fall Professional Risperdal Grand Mal Convulsion Other (Risperidone) SS 3 MG QD Somnolence Risperdal (Risperidone) SS 4 MG QD Risperdal (Risperidone) SS 5 MG QD Risperdal (Risperidone) SS 6 MG QD Leponex (Clozapine) SS 12.5 MG QD Leponex (Clozapine) SS 25 MG QD Zyprexa (Olanzapine) SS 10 MG QD Zyprexa (Olanzapine) SS 15 MG QD Zyprexa (Olanzapine) SS 10 MG QD Zyprexa (Olanzapine) SS 20 MG QD Bronchoretard (Theophylline) SS 350 MG QD Tavor (Lorazepam) C Acetylsalicylic Acid C Pulmicord (Budesonide) C 22-Feb-2006 08:20 AM Page: 2068 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Berotec (Fenoterol Hydrobromide) C Date:05/06/04ISR Number: 4357300-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040300650 Age:82 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL 1 MG, 1 IN 1 DAY, ORAL Lasix (Furosemide) C Accupril (Quinapril Hydrochloride) C Aricept (Donepezil Hydrochloride) C Megace (Megestrol Acetate) C Date:05/06/04ISR Number: 4357307-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040406366 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 2 IN 1 DAY, ORAL Date:05/07/04ISR Number: 4356086-6Report Type:Direct Company Report #CTU 218141 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Tylenol 1000mg PS 1 X Initial or Prolonged Medication Error ADMINISTRATIO Self-Medication N (OVER DOSE Somnolence OF ANOTHERS Vomiting MEDS) Colace 100 Mg SS Geodon 40 Mg SS Mvi SS Risperidone 3 Mg SS Seroquel 100 Mg SS Sertraline 150 Mg SS Date:05/07/04ISR Number: 4356087-8Report Type:Direct Company Report #CTU 218140 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Motrin 800 Mg PS 1X OVERDOSE Initial or Prolonged Blood Glucose Increased Amitriptyline 50 Mg SS Coma Benadryl 50 Mg SS Lethargy Fluphenazine 5mg SS Medication Error Ativan 2mg SS Resperidal 4 Mg SS 22-Feb-2006 08:20 AM Page: 2069 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/04ISR Number: 4356734-0Report Type:Expedited (15-DaCompany Report #2004UW07545 Age:14 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Seroquel PS ORAL 250 MG QD PO Professional Risperdal SS Paxil C Trileptal C Date:05/07/04ISR Number: 4356955-7Report Type:Expedited (15-DaCompany Report #AR-JNJFOC-20040306077 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Murder Foreign Risperdal Consta Initial or Prolonged Physical Assault Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:05/07/04ISR Number: 4356961-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040406512 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Risperdal Cardiac Arrest Health (Risperidone) Heart Rate Increased Professional Tablets PS ORAL 8 MG, IN 1 Somnolence Company DAY, ORAL Representative Tercian (Cyamemazine) C Rivotril (Clonazepam) C Lepticur (Tropatepine Hydrochloride) C Theralene (Alimemazine Tartrate) C Date:05/07/04ISR Number: 4356963-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040500008 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Foreign Risperdal Consumer (Risperidone) Unspecified PS ORAL ORAL Benzodiazepine Derivatives And Preparations (Benzodiazepine Derivatives) SS ORAL ORAL Date:05/10/04ISR Number: 4355482-0Report Type:Expedited (15-DaCompany Report #NO-MERCK-0405NOR00002 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Vioxx PS Merck & Co., Inc ORAL Risperidone SS ORAL 22-Feb-2006 08:20 AM Page: 2070 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Atenolol C ORAL YR Warfarin Sodium C UNKNOWN YR Date:05/10/04ISR Number: 4357377-5Report Type:Expedited (15-DaCompany Report #DSA_24280_2004 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Tavor PS ORAL 0.5 MG QD PO Initial or Prolonged Facial Bones Fracture Health Tavor SS ORAL 1 MG QD PO Fall Professional Tavor SS ORAL 2 MG QD PO Grand Mal Convulsion Other Tavor SS ORAL 2.5 MG QD PO Tavor SS ORAL 4 MG Q DAY PO Bronchoretard SS ORAL 350 MG QD PO Cipramil SS ORAL 20 MG QD PO Leponex SS ORAL 25 MG QD PO Leponex SS ORAL 12.5 MG QD PO Risperdal SS ORAL 6 MG QD PO Risperdal SS ORAL 5 MG QD PO Risperdal SS ORAL 4 MG QD PO Risperdal SS ORAL 3 MG QD PO Zyprexa SS ORAL 10 MG Q DAY PO Zyprexa SS ORAL 20 MG QD PO Zyprexa SS ORAL 15 MG QD PO Zyprexa SS ORAL 10 MG Q DAY PO Acetylsalicylic Acid C Pulmicort C Berotec C Date:05/10/04ISR Number: 4357502-6Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20040405911 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Drug Level Increased Health (Rispeidone) Professional Unspecified PS ORAL ORAL Sinemet Plus (Sinemet) SS ORAL 7.5 MG, IN 1 DAY, ORAL Priadel (Lithium Carbonate) SS ORAL 600 MG, ORAL Asasantin C Lipitor (Atorvastatin) C Mirapexin (Pramipexole Dihydrochloride) C Nu-Seals (Acetylsalicylic Acid) C Flurazepam C 22-Feb-2006 08:20 AM Page: 2071 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/04ISR Number: 4358160-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040500685 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperdal Initial or Prolonged Professional (Risperidone) Company Unspecified PS ORAL 2 MG, 2 IN 1 Representative DAY, ORAL Cogentin (Benzatropine Mesilate) C Date:05/10/04ISR Number: 4358162-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040402742 Age:76 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Risperdal Professional (Risperidone) Unspecified PS ORAL 1 MG, 3 IN 1 DAY, ORAL Zoloft (Sertraline Hydrochloride) C Date:05/10/04ISR Number: 4358163-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202537 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bicarbonate Health Risperdal Initial or Prolonged Increased Professional (Risperidone) Disability Blood Fibrinogen Tablets PS ORAL 1 MG, 1 IN 1 Increased DAY, ORAL Haematocrit Decreased Cylert (Pemoline Haemoglobin Decreased Magnesium) C International Normalised Klonopin Ratio Decreased (Clonazepam) C Necrosis Propecia Painful Erection (Finasteride) C Priapism Lexapro (All Other Self-Medication Therapeutic White Blood Cell Count Products) C Increased Date:05/10/04ISR Number: 4358206-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040405806 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 2 IN 1 DAY, ORAL Date:05/11/04ISR Number: 4356272-5Report Type:Expedited (15-DaCompany Report #NZ-JNJFOC-20040500005 Age:30 YR Gender:Male I/FU:I Outcome PT Other Apathy Blood Iron Increased Mental Disorder 22-Feb-2006 08:20 AM Page: 2072 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mood Swings Therapeutic Response Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Consumer (Risperidone) Tablets PS START DATE: 4-5 YEARS AGO Date:05/11/04ISR Number: 4356273-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040405933 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Foreign Risperdal Retinal Artery Occlusion Health (Risperidone) Professional Unspecified PS 4 MG, IN 1 DAY, Date:05/11/04ISR Number: 4357165-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040406560 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL Date:05/11/04ISR Number: 4358112-7Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20040406289 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Foreign Risperdal Leukopenia Health (Risperidone) PS ORAL 2 MG, IN 1 Neutrophil Count Professional DAY, ORAL Decreased Date:05/11/04ISR Number: 4358113-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040404264 Age:93 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Foreign Risperdal Initial or Prolonged Hyperkinesia Health (Risperidone) Hyperthermia Professional Tablets PS ORAL 6 MG, IN 1 Hypertonia DAY, ORAL Lung Disorder Somnolence Date:05/11/04ISR Number: 4358230-3Report Type:Expedited (15-DaCompany Report #2004025545 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delirium Foreign Atarax (Tablet) Gamma-Glutamyltransferase Health (Hydroxyzine Increased Professional Hydrochloride) PS ORAL 62.5 MG ORAL Hepatic Function Abnormal Risperidone (Risperidone) SS ORAL ORAL Amisulpride (Amisulpride) C 22-Feb-2006 08:20 AM Page: 2073 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/04ISR Number: 4359100-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040500051 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Risperdal Initial or Prolonged Face Oedema Health (Risperidone) Prurigo Professional Tablets PS ORAL SEE IMAGE Psychotic Disorder Tranxene Rash Erythematous (Clorazepate Dipotassium) C Lepticur (Tropatepine Hydrochloride) C Date:05/12/04ISR Number: 4359101-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040401553 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Risperdal Consta Agitation Health (Risperidone) Aphasia Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Blood Albumin Increased WEEK, Blood Creatine INTRAMUSCULAR Phosphokinase Increased Risperidone Blood Creatinine (Risperidone) C Increased Blood Pressure Increased Condition Aggravated Confusional State Drug Toxicity Dysarthria Dysphagia Dysstasia Hypotonia Psychotic Disorder Refusal Of Treatment By Patient Salivary Hypersecretion Treatment Noncompliance Date:05/12/04ISR Number: 4359471-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040500834 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sickle Cell Anaemia With Health Risperdal M-Tabs Initial or Prolonged Crisis Professional (Risperidone) Tablets PS ORAL 3 MG, 2 IN 1 DAY, ORAL Zyprexa (Olanzapine) C Date:05/13/04ISR Number: 4359996-9Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040501168 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intracranial Pressure Foreign Risperidone Increased Health (Risperidone) PS 1 MG Professional Lithium (Lithium) SS 1000 MG 22-Feb-2006 08:20 AM Page: 2074 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/04ISR Number: 4359821-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040303693 Age:72 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Foreign Risperdal Second Degree Health (Risperidone) Balance Disorder Professional Solution PS ORAL SEE IMAGE Bradycardia Risperdal Consta Drug Interaction (Risperidone) Hypotension Microspeheres SS INTRAMUSCULAR 50 MG, 1 IN Hypothermia 14 DAY, Incoherent INTRA-MUSCULA Lung Disorder R Overdose Deroxat (Paroxetine Pancytopenia Hydrochloride) C Septic Shock Lysanxia (Prazepam) C Staphylococcal Infection Duphalac (Lactulose) C Date:05/14/04ISR Number: 4359828-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040201562 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Benign Soft Tissue Foreign Risperdal Consta Initial or Prolonged Neoplasm Health (Risperidone) Fat Necrosis Professional Microspheres PS INTRAMUSCULAR SEE IMAGE Injection Site Mass Date:05/14/04ISR Number: 4360081-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040201239 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Eczema Foreign Risperdal Consta Eyelid Oedema Health (Risperidone) Face Oedema Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Rash WEEK, Rash Pruritic INTRA-MUSCULA R Amoxycillin (Amoxicillin) SS ORAL 250 MG, ORAL Rispedal Consta (Risperidone) Microspheres C Risperdal (Risperidone) C Thyroxine (Levothyroxine Sodium) C Date:05/14/04ISR Number: 4360272-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040404099 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 0.5 MG, ORAL 22-Feb-2006 08:20 AM Page: 2075 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/04ISR Number: 4360273-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040401978 Age:95 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL ORAL Professional Date:05/14/04ISR Number: 4360274-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040401175 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL ORAL Professional Date:05/14/04ISR Number: 4360341-3Report Type:Expedited (15-DaCompany Report #NSADSS2002039613 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deafness Consumer Risperdal Fatigue (Risperidone) Hyperprolactinaemia Tablets PS ORAL 3 MG, 1 IN 1 Hypothermia DAY, ORAL Menorrhagia Lithium (Lithium) C Ovarian Cyst Clonopin Vaginal Haemorrhage (Clonazepam) C Weight Increased Levoxyl (Levothyroxine Sodium) C Date:05/14/04ISR Number: 4360342-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040500945 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Study Risperidone Initial or Prolonged Gastrointestinal Necrosis Health (Risperidone) Intestinal Ischaemia Professional Unspecified PS Mental Status Changes Olanzapine Pneumonia (Olanzapine) SS Quetiapine (Quetiapine) SS Trazodone (Trazodone) C Mvi (Multivitamins) C Feso4 (Ferrous Sulfate) C Carbamazepine (Carbamazepine) C Date:05/14/04ISR Number: 4360343-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040500877 Age:98 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Tablets PS ORAL 0.5 MG, ORAL 22-Feb-2006 08:20 AM Page: 2076 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/14/04ISR Number: 4360380-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031102704 Age:94 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Effect Decreased Foreign Risperdal Drug Level Increased Health (Risperidone) General Physical Health Professional Tablets PS ORAL 0.5 MG, 2 IN Deterioration 1 DAY, ORAL Incontinence Digoxin (Digoxin) C Mobility Decreased Enalapril Respiratory Disorder (Enalapril) C Warfarin (Warfarin) C Date:05/14/04ISR Number: 4360420-0Report Type:Expedited (15-DaCompany Report #A005496 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Sertraline Initial or Prolonged Blood Pressure (Sertraline) PS ORAL 150 MG Required Fluctuation (DAILY), ORAL Intervention to Drug Ineffective Luvox (Fluvoxamine Prevent Permanent Feeling Abnormal Maleate) SS ORAL ORAL Impairment/Damage Headache Risperdal Heart Rate Irregular (Risperidone) SS ORAL (DAILY), ORAL Heat Exhaustion Florinef Intraocular Pressure Test (Fludrocortisone Abnormal Acetate) C Muscle Rigidity Vitamins (Vitamins) C Oropharyngeal Swelling Acidophyllus Orthostatic Hypotension (Lactobacillus Pain Acidophilus) C Paraesthesia Tylenol Phaeochromocytoma (Paracetamol) C Serotonin Syndrome Ibuprofen Skin Discolouration (Ibuprofen) C Thyroid Disorder Aspirin Tourette'S Disorder (Acetylsalicylic Weight Fluctuation Acid) C Date:05/17/04ISR Number: 4359864-2Report Type:Direct Company Report #CTU 218822 Age: Gender:Female I/FU:I Outcome PT Life-Threatening Abnormal Behaviour Disability Accident Required Diabetes Mellitus Intervention to Disturbance In Attention Prevent Permanent Drug Intolerance Impairment/Damage Dyspnoea Ear Haemorrhage Epistaxis Feeling Abnormal Heart Rate Decreased Hypersomnia Hypertension Medication Error Mental Impairment Nervous System Disorder Oral Intake Reduced Tremor 22-Feb-2006 08:20 AM Page: 2077 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting Report Source Product Role Manufacturer Route Dose Duration Risperdal 1 Mg PS Date:05/17/04ISR Number: 4360877-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031102700 Age:81 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abasia Foreign Risperdal Drug Level Increased Health (Risperidone) Dysstasia Professional Tablets PS ORAL 0.5 MG, IN 1 General Physical Health DAY, ORAL Deterioration Lisinopril Incontinence (Lisinopril) C Respiratory Rate Aspirin Decreased (Acetylsalicylic Acid) C Amiodarone (Amiodarone) C Hydrocortisone (Hydrocortisone) C Omeprazole (Omeprazole) C Transderm Nitro (Glyceryl Trinitrate) C Furosemide (Furosemide) C Date:05/17/04ISR Number: 4360923-9Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20040502888 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Foreign Risperdal Initial or Prolonged Blood Calcium Increased Literature (Risperidone) Constipation Health Tablets PS ORAL 6 MG, IN 1 Depressed Level Of Professional DAY, ORAL Consciousness Hypercalcaemia Hypotension Pyrexia Renal Failure Urinary Retention Vomiting Date:05/17/04ISR Number: 4360946-XReport Type:Expedited (15-DaCompany Report #2004020017 Age:0 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Foreign Zoloft (Sertraline) PS ORAL 150 MG (1 IN Initial or Prolonged Pregnancy Health 1 D), ORAL Other Drug Withdrawal Syndrome Professional Risperidone Neonatal (Risperidone) SS ORAL 0.25 MEQ (1 Hyperventilation IN 1 D), ORAL Laryngomalacia Neonatal Disorder Tardive Dyskinesia 22-Feb-2006 08:20 AM Page: 2078 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/04ISR Number: 4361587-0Report Type:Expedited (15-DaCompany Report #DEU-2004-0000822 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Literature Morphine Sulfate PS 0.2 MG, Pregnancy Health SINGLE Drug Interaction Professional Risperidone Heart Rate Increased (Risperidone) SS 8 MG, HS, Hypotension Lithium (Lithium) C Date:05/17/04ISR Number: 4362160-0Report Type:Expedited (15-DaCompany Report #2004022821 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign ; PS ORAL 50 MG (1 IN 1 Erectile Dysfunction Health D), ORAL Imprisonment Professional Risperidone Pain Company (Risperidone) SS ORAL 2 MG, ORAL Priapism Representative All Other Therapeutic Products (All Other Therapeutic Products) SS Diazepam C Date:05/17/04ISR Number: 4362303-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040304613 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Atherosclerosis Health Risperdal Cerebrovascular Accident Professional (Risperidone) Tablets PS ORAL ORAL Date:05/17/04ISR Number: 4363401-6Report Type:Periodic Company Report #S04-USA-01570-01 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anger Consumer Namenda (Memantine) PS Drug Interaction Risperdal Inhibition (Risperidone) SS 5 MG QD Aricept (Donepezil Hydrochloride) C Zoloft (Sertraline Hydrochloride) C Ranitidine C Date:05/18/04ISR Number: 4359759-4Report Type:Periodic Company Report #DE-JNJFOC-20040106029 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Stress Disorder Health Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Professional Risperdal Consta SS INTRAMUSCULAR Metoprolol C OROPHARINGEAL Fluvoxamin C 22-Feb-2006 08:20 AM Page: 2079 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/04ISR Number: 4362819-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040300045 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Unspecified PS Date:05/18/04ISR Number: 4362887-0Report Type:Expedited (15-DaCompany Report #2004030086 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Hydroxyzine Initial or Prolonged Drug Exposure During Literature Hydrochloride Pregnancy Health (Tablet) Pregnancy Professional (Hydroxyzine Psychotic Disorder Hydrochloride) PS 12.5 MG (4 Thrombophlebitis WK), Alprazolam (Alprazolam) (Alprazolam) SS Ampicillin/Sulbactam (Ampicillin, Sulbactam) SS Mirtazapine (Mirtazapine) SS Risperidone (Risperidone) SS Fluvoxamine (Fluvoxamine) SS Quetiapine (Quetiapine) C Diazepam (Diazepam) C Thioridazine (Thioridazine) C Carbamazepine (Carbamazepine) C Biperiden (Biperiden) C Troxerutin (Troxerutin) C Enoxaparin (Heparin) C Date:05/18/04ISR Number: 4363094-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040401494 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Risperdal Consta Initial or Prolonged Increased Health (Risperidone) Red Blood Cell Professional Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN Sedimentation Rate 2 WEEK, Increased INTRA-MUSCULA R 22-Feb-2006 08:20 AM Page: 2080 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/04ISR Number: 4360073-1Report Type:Periodic Company Report #JP-JNJFOC-20040301453 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Health Risperdal PS OROPHARINGEAL 17 DAY Other Haematocrit Decreased Professional Risperdal SS OROPHARINGEAL 17 DAY Haemoglobin Decreased Nifedipine SS OROPHARINGEAL 43 DAY Insomnia Furosemide SS OROPHARINGEAL 43 DAY Red Blood Cell Count Spironolactone SS OROPHARINGEAL 30 DAY Decreased Aminophylline SS INTRAVENOUS Staphylococcal Infection DRIP 14 DAY Teicoplanin SS INTRAVENOUS DRIP 11 DAY Flunitrazepam SS OROPHARINGEAL 16 DAY Bromhexine Hydrochloride C OROPHARINGEAL 44 DAY Ambroxal Hydrochloride C OROPHARINGEAL 44 DAY Proteins, Amino Acid And Preparations C INTRAVENOUS DRIP 20 DAY Panthenol C INTRAVENOUS DRIP 20 DAY Magnesium Oxide C OROPHARINGEAL 23 DAY Sodium Picosulfate C OROPHARINGEAL 4 DAY Date:05/19/04ISR Number: 4360076-7Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20040301740 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Risperdal PS INTRA-UTERINE Initial or Prolonged Caesarean Section Professional Imovane SS INTRA-UTERINE Congenital Anomaly Cleft Lip And Palate Vival SS INTRA-UTERINE Convulsion Neonatal Insulin C INTRA-UTERINE Drug Exposure During Anaethesia C Pregnancy Neonatal Disorder Pregnancy Ultrasound Antenatal Screen Abnormal Vertebral Injury Date:05/19/04ISR Number: 4360077-9Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040502104 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Leg Amputation Risperdal PS Other Vasculitis Date:05/19/04ISR Number: 4360079-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040302761 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Blood Alkaline Phosphatase Increased Blood Chloride Decreased Blood Glucose Increased Blood Potassium Decreased 22-Feb-2006 08:20 AM Page: 2081 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Pressure Diastolic Decreased Chills Report Source Product Role Manufacturer Route Dose Duration Hepatomegaly Risperdal PS OROPHARINGEAL 1 in 4 hours Hyperhidrosis as needed Internal Hernia Clozapine SS OROPHARINGEAL Leukocytosis Celexa C Lower Respiratory Tract Ibuprofen C Infection Norvasc C Neuroleptic Malignant Prevacid C Syndrome Spironolactone C Oxygen Saturation Detrol La C Decreased Demodex C Procedural Site Reaction Theophylline C Protein Total Increased Singulair C Pyrexia Quinine Sulfate C Respiratory Rate Trazodone C Increased Valproic Acid C Urinary Tract Infection Flovent C Vomiting Tylenol C Vistaril C Guaifenesin C Duoneb C Duoneb C Albuterol C Date:05/19/04ISR Number: 4360080-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040403936 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Health Risperdal PS OROPHARINGEAL Initial or Prolonged Somnolence Professional Tenordate C UNKNOWN Tenordate C UNKNOWN 2 tablets per day Lasilix 40 C UNKNOWN Modopar Lp C UNKNOWN Modopar Lp C UNKNOWN Deprenyl 5 C UNKNOWN Trivastal Lp C UNKNOWN Nootropyl C UNKNOWN Floxyfral C UNKNOWN Rivotril C UNKNOWN 20 drops in the evening Chondrosulf C Date:05/19/04ISR Number: 4360092-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040502791 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperkalaemia Risperdal PS UNKNOWN Date:05/19/04ISR Number: 4360093-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040502071 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2082 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/04ISR Number: 4360099-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040502087 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS UNKNOWN Date:05/19/04ISR Number: 4360105-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040503065 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Risperdal PS OROPHARINGEAL 903 DAY Oculogyration Risperdal SS OROPHARINGEAL 903 DAY Sinus Arrhythmia Risperdal SS OROPHARINGEAL 903 DAY Somnolence Trihexyphenidyl Speech Disorder Hydrochloride C OROPHARINGEAL Tremor Nitrazepam C OROPHARINGEAL Levomepromazine Maleate C OROPHARINGEAL 5 DAY Zopiclone C OROPHARINGEAL Date:05/19/04ISR Number: 4360128-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040502773 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Risperdal PS OROPHARINGEAL Dysphagia Haloperidol SS OROPHARINGEAL Trihexyphenidyl Hydrochloride C OROPHARINGEAL Date:05/19/04ISR Number: 4360129-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040403943 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Rupture Health Risperdal Consta PS INTRAMUSCULAR Circulatory Collapse Professional Chlorpromazine C UNKNOWN Dyspnoea Chlorpromazine C UNKNOWN 75mg per Pulse Pressure Decreased night Olanzapine C UNKNOWN 5mg per night Procyclidine C Date:05/19/04ISR Number: 4360246-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031204590 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombosis Health Risperdal PS INTRAMUSCULAR 152 DAY Initial or Prolonged Professional Risperdal SS INTRAMUSCULAR 152 DAY Risperdal C OROPHARINGEAL Risperdal C OROPHARINGEAL Date:05/19/04ISR Number: 4363873-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040303794 Age:73 YR Gender:Male I/FU:F Outcome PT Life-Threatening Alanine Aminotransferase Hospitalization - Increased Initial or Prolonged Aspartate Aminotransferase 22-Feb-2006 08:20 AM Page: 2083 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Blood Creatine Phosphokinase Increased Convulsion Report Source Product Role Manufacturer Route Dose Duration Dementia Alzheimer'S Type Foreign Risperdal Hepatic Function Abnormal Health (Risperidone) Hepatocellular Damage Professional Unspecified PS ORAL 2 MG, 1 IN 1 Leukopenia DAY, ORAL Pneumonia Sodium Valproate Schizophrenia (Valproate Sodium) Unspecified SS ORAL 400 MG, 1 IN 1 DAY, ORAL Tiapride Hydrochloride (Tiapride Hydrochloride) Unspecified SS ORAL 100 MG, 1 IN 1DAY, ORAL Flunitrazepam (Flunitrazepam) Unspecified C Estazolam (Estazolam) Unspecified C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Biperiden Hydrochloride (Biperidone Hydrochloride) C Date:05/19/04ISR Number: 4363874-9Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20040501186 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychiatric Symptom Foreign Risperdal Initial or Prolonged Refusal Of Treatment By Health (Risperidone) Patient Professional Unspecified PS HIGHER DOSE; LOWER DOSE Zyprexa (Olanzapine) C Citalopram (Citalopram) C Depoprovera (Medroxyprogesterone Acetate) C Loramet (Lormetazepam) C Date:05/19/04ISR Number: 4363890-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040106029 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Family Stress Foreign Risperdal Consta Initial or Prolonged Study (Risperidone) Health Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Professional WEEK, INTRA-MUSCULA R 22-Feb-2006 08:20 AM Page: 2084 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal Consta (Risperidone) Microspheres SS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Metoprolol C Fluvoxamine C Date:05/19/04ISR Number: 4364208-6Report Type:Expedited (15-DaCompany Report #S04-USA-02686-01 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Self Injurious Behaviour Health Lexapro Initial or Prolonged Suicidal Ideation Professional (Escitalopram) PS ORAL 10 MG QD PO Lexapro (Escitalopram) SS ORAL 20 MG QD PO Lexapro (Escitalopram) SS ORAL 30 MG QD PO Risperidone SS ORAL 0.5 MG QD PO Risperidone SS ORAL 1 MG QD PO Risperidone SS ORAL 1.5 MG QD PO Date:05/20/04ISR Number: 4361114-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040502151 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:05/20/04ISR Number: 4362615-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040501364 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infertility Consumer Risperdal Liver Disorder (Risperidone) Pituitary Tumour Benign Unspecified PS ORAL ORAL Date:05/20/04ISR Number: 4362616-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040501597 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Unspecified PS ORAL ORAL Date:05/20/04ISR Number: 4364039-7Report Type:Direct Company Report #CTU 219150 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Tardive Dyskinesia Risperdal 6 Mg Tabs PS ORAL 1 PO SID ORAL Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:20 AM Page: 2085 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/20/04ISR Number: 4365619-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040302761 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Health Risperdal Initial or Prolonged Blood Alkaline Professional (Risperidone) PS ORAL 0.5 MG, ORAL Phosphatase Increased Clozapine Blood Chloride Decreased (Clozapine) Tablets SS ORAL 125 MG, 2 IN Blood Glucose Increased 1 DAY, ORAL C-Reactive Protein Celexa (Citalopram Increased Hydrobromide) C Chills Ibuprofen Hepatomegaly (Ibuprofen) C Hernia Norvasc (Amlodipine Hyperhidrosis Besilate) C Leukocytosis Prevacid Lung Infection (Lansoprazole) C Neuroleptic Malignant Spironolactone Syndrome (Spironolactone) C Pyrexia Detrol La Red Blood Cell (Tolterodine Sedimentation Rate L-Tartrate) C Increased Demodex (Torasemide) C Urinary Tract Infection Theophylline Vomiting (Theophylline) C Singulair (Montelukast Sodium) C Quinine Sulfate (Quinine Sulfate) C Trazodone (Trazodone) C Valproic Acid (Valproic Acid) C Flovent (Fluticasone Propionate) C Tylenol (Paracetamol) C Vistaril (Hydroxyzine Embonate) C Guaifenesin (Guaifenesin) C Duoneb (Medihaler-Duo) C Albuterol (Salbutamol) C Date:05/20/04ISR Number: 4365620-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040502087 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS 22-Feb-2006 08:20 AM Page: 2086 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/20/04ISR Number: 4365621-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040502071 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Date:05/20/04ISR Number: 4365671-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040301453 Age:62 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agranulocytosis Foreign Risperdal Other Anaemia Health (Risperidone) PS ORAL SEE IMAGE Anxiety Professional Nifedipine Bone Marrow Depression (Nifedipine) Condition Aggravated Unspecified SS ORAL 40 MG, IN 1 Drug Interaction DAY, ORAL Insomnia Furosemide Irritability (Furosemide) Leukopenia Unspecified SS ORAL 40 MG, IN 1 Pyrexia DAY, ORAL Spironolactone (Spironolactone) Unspecified SS ORAL 50 MG, IN 1 DAY, ORAL Aminophylline (Aminophylline) Unspecified SS INTRAVENOUS DRIP 500 MG, IN 1 DAY, INTRAVENOUS DRIP Teicoplanin (Teicoplanin) Unspecified SS INTRAVENOUS DRIP 400 MG, IN 1 DAY, INTRAVENOUS DRIP Flunitrazepam (Flunitrazepam) Unspecified SS ORAL 1 MG, IN 1 DAY, ORAL Bromhexine Hydrochloride (Bromhexine Hydrochloride) C Amroxal Hydrochloride (Ambroxol Hydrochloride) C Proteins, Amino Acid And Preparation (All Other Therapeutic Products) C Panthenol (Panthenol) C Magnesium Oxide (Magnesium Oxide) C 22-Feb-2006 08:20 AM Page: 2087 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium Picosulfate (Sodium Picosulfate) C Date:05/20/04ISR Number: 4365726-7Report Type:Expedited (15-DaCompany Report #2004022821 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Zoloft (Sertraline) PS ORAL 50 MG (1 IN 1 Initial or Prolonged Imprisonment Health D), ORAL Other Priapism Professional Risperidone Sexual Dysfunction Company (Risperidone) SS ORAL 2 MG, ORAL Representative All Other Therapeutic Products (All Other Therapeutic Products) SS Diazepam C Date:05/20/04ISR Number: 4365897-2Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20040301740 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Foreign Risperdal Initial or Prolonged Blood Glucose Increased Health (Risperidone) Congenital Anomaly Caesarean Section Professional Tablets PS INTRA-UTERINE 6MG, IN 1 Cleft Lip And Palate DAY, Congenital Anomaly INTRAUTERINE Convulsion Neonatal Imovane (Zopiclone) Drug Exposure During Tablets SS INTRA-UTERINE INTRA-UTERNIN Pregnancy E Drug Interaction Vival (Diazepam) Neonatal Disorder Tablets SS INTRA-UTERINE INTRA-UTERNIN Pregnancy E Vertebral Injury Insulin (Injection) Insulin C Anaethesia (Anaesthetics) C Date:05/20/04ISR Number: 4365900-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20031204590 Age:55 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombosis Foreign Risperdal Initial or Prolonged Study (Risperidone) Health Microspheres PS INTRAMUSCULAR 25 & 37.5 MG, Professional 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Unspecified) Risperidone C 22-Feb-2006 08:20 AM Page: 2088 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/20/04ISR Number: 4365905-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040403943 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Rupture Foreign Risperdal Consta Circulatory Collapse Health (Risperidone) Dyspnoea Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Pulse Pressure Decreased WEEK, INTRA-MUSCULA R Chlorpromazine (Chlorpromazine) C Olanzapine (Olanzapine) C Procyclidine (Procyclidine) C Date:05/20/04ISR Number: 4365922-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040502791 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperkalaemia Foreign Risperdal Consumer (Risperidone) Unspecified PS Date:05/20/04ISR Number: 4365923-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040403936 Age:64 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Foreign Risperdal Initial or Prolonged Somnolence Health (Risperidone) Professional Tablets PS ORAL 4 MG, 2 IN 1 DAY, ORAL Tenordate (Nif-Ten "Imperial") C Lasilix 40 (Furosemide) C Modopar Lp (Madopar) C Deprenyl 5 (Selegiline) C Trivastal Lp (Piribedil) C Nootropyl (Piracetam) C Floxyfral (Fluvoxamine Maleate) C Rivotril (Clonazepam) C Chondrosulf (Chondroitin Sulfate Sodium) C Date:05/20/04ISR Number: 4365931-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040502773 Age: Gender: I/FU:I Outcome PT Other Aphagia Areflexia 22-Feb-2006 08:20 AM Page: 2089 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Interaction Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Haloperidol (Haloperidol) Unspecified SS ORAL ORAL Trihexyphenidyl Hydrochloride C Date:05/20/04ISR Number: 4365933-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040503065 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Foreign Risperdal Oculogyration Health (Risperidone) Sinus Arrhythmia Professional Unspecified PS ORAL ORAL : 9 MG, Somnolence 1 IN DAY, Speech Disorder ORAL : 6 MG, Tremor IN 1 DAY, ORAL Trihexyphenidyl Hydrochloride C Nitrazepam C Levomepromazine Maleate C Zopiclone C Date:05/20/04ISR Number: 4365953-9Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040502104 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Leg Amputation Foreign Risperdal Other Vasculitis Health (Risperidone) Professional Unspecified PS Date:05/20/04ISR Number: 4366323-XReport Type:Direct Company Report #CTU 219458 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Risperidone PS ORAL 2 MG BID PO Initial or Prolonged Heart Rate Decreased Risperidone SS ORAL 1 MG BID PO Required Hypothermia Intervention to Prevent Permanent Impairment/Damage Date:05/21/04ISR Number: 4361908-9Report Type:Periodic Company Report #03-12-1617 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Diarrhoea Thorazine PS Glaxosmithkline UNKNOWN Lethargy Clozapine SS ORAL 50MG Per day Risperdal SS UNKNOWN Depakote SS UNKNOWN 22-Feb-2006 08:20 AM Page: 2090 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/21/04ISR Number: 4362097-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040403188 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericarditis Risperdal PS OROPHARINGEAL 3 DAY Initial or Prolonged Pneumothorax Zoloft C Strattera C Date:05/21/04ISR Number: 4362393-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040503067 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lupus-Like Syndrome Risperdal PS Date:05/21/04ISR Number: 4362394-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040503261 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Risperdal PS OROPHARINGEAL Prilosec C Aspirin C Actonel C Lopressor C Paxil C Dyazide C Dyazide C Depakote C Bextra C Norvasc C Xanax C Date:05/21/04ISR Number: 4362395-7Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20040303982 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Health Risperdal PS OROPHARINGEAL Pregnancy Professional Imovane SS OROPHARINGEAL as necessary Vival SS OROPHARINGEAL Insulin Insulatard C INTRAVENOUS From week 32 of pregnancy Date:05/21/04ISR Number: 4364535-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040502151 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 2 IN 1 DAY, ORAL Date:05/21/04ISR Number: 4364623-0Report Type:Expedited (15-DaCompany Report #232304K04USA Age:43 YR Gender:Male I/FU:I Outcome PT Death Bipolar Disorder Other Completed Suicide Condition Aggravated 22-Feb-2006 08:20 AM Page: 2091 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depression Visual Disturbance Report Source Product Role Manufacturer Route Dose Duration Consumer Rebif (Interferon Health Beta) PS SUBCUTANEOUS 44 MCG, 3 IN Professional 1 WEEKS, SUBCUTANEOUS Methylprednisolone SS INTRAVENOUS INTRAVENOUS Alprazolam SS Risperidone SS Date:05/24/04ISR Number: 4366402-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040503067 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lupus-Like Syndrome Foreign Risperdal Health (Risperidone) PS Professional Date:05/24/04ISR Number: 4366403-9Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20040303982 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Foreign Risperdal Caesarean Section Health (Risperidone) Cleft Lip And Palate Professional Tablets PS ORAL 6 MG IN 1 DAY Convulsion Neonatal ORAL Drug Exposure During Imovane (Zopiclone) Pregnancy Tablets SS AS NECESSARY Pregnancy Insulin Insulatard Vertebral Injury (Insulin Injection, Isophane) Injection C Date:05/24/04ISR Number: 4367197-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040403188 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericarditis Health Risperdal Initial or Prolonged Pneumothorax Professional (Risperidone) Company Solution PS ORAL 0.1 ML, 1 IN Representative 1 DAY, ORAL Zoloft (Sertraline Hydrochloride) C Strattera (All Other Therapeutic Products) C Date:05/24/04ISR Number: 4367198-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040503261 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Prilosec (Omeprazole) C 22-Feb-2006 08:20 AM Page: 2092 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspirin (Acetylsalicylic Acid) C Actonel (Risedronate Sodium) C Lopressor (Metoprolol Tartrate) C Paxil (Paroxetine Hydrochloride) C Dyazide (Dyazide) C Depakote (Valproate Semisodium) C Bextra (Bucindolol Hydrochloride) C Norvasc (Amlodipine Besilate) C Xanax (Alprazolam) C Date:05/25/04ISR Number: 4365387-7Report Type:Expedited (15-DaCompany Report #04P-062-0260467-00 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Akineton (Biperiden) Initial or Prolonged Suicide Attempt Health (Biperiden) PS ORAL PER ORAL Professional Mirtazapine SS ORAL PER ORAL Lorazepam SS ORAL PER ORAL Risperidone SS ORAL PER ORAL Zop 7.5 SS ORAL PER ORAL Isopromethazine Hydrochloride SS ORAL PER ORAL Dominal SS ORAL PER ORAL Date:05/25/04ISR Number: 4370648-1Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040502116 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Risperidone Initial or Prolonged Mood Altered Health (Risperidone) Psychotic Disorder Professional Microspheres PS INTRAMUSCULAR 27.5 MG, INTRA-MUSCULA R; 50 MG INTRA-MUSCULA R Risperdal (Risperidone) Tablets C Promethazine (Promethazine) Tablets C Oxazepam (Oxazepam) Tablets C 22-Feb-2006 08:20 AM Page: 2093 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/04ISR Number: 4370649-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040206106 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disease Recurrence Foreign Risperdal Consta Drug Interaction Health (Risperidone) Schizophrenia Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Suicidal Ideation WEEK, Tachyphylaxis INTRA-MUSCULA R Risperdal (Risperidone) Unspecified SS ORAL 6 MG, 1 IN 1 DAY, ORAL Lustral (Sertraline Hydrochloride) C Depakote (Valproate Semisodium) C Date:05/26/04ISR Number: 4365504-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040504842 Age:99 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:05/26/04ISR Number: 4365505-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040505336 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:05/26/04ISR Number: 4365506-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040505340 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Risperdal PS OROPHARINGEAL Convulsion Ativan C Paxil C Trazadone C Date:05/26/04ISR Number: 4365507-4Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040405310 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cryptogenic Organizing Risperdal PS OROPHARINGEAL Pneumonia Date:05/26/04ISR Number: 4365508-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040306060 Age:10 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperdal PS UNKNOWN Insulin-Dependent Prozac C Pancreatic Insufficiency 22-Feb-2006 08:20 AM Page: 2094 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/04ISR Number: 4365628-6Report Type:Direct Company Report #CTU 219579 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperidone 3 Mg Janssen PS Janssen ORAL 3 MG QHS ORAL Doxepin C Flonase Ns C Phenytoin C Ranitidine C Apap C Maalox C Mom C Date:05/26/04ISR Number: 4365712-7Report Type:Direct Company Report #CTU 219541 E Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Pressure Decreased Olanzapine PS 20 MG QHS Hospitalization - Body Temperature [PRIOR TO Initial or Prolonged Decreased ARRIVAL] Bradycardia Risperidone SS PTA Depressed Level Of Carabamazepine C Consciousness Trazodone C Fluconazole C Unasyn C Date:05/26/04ISR Number: 4366156-4Report Type:Direct Company Report #CTU 219560 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Electrocardiogram Qt Risperidone 1 Mg Intervention to Corrected Interval Janssen PS Janssen ORAL 1 MG Q12H Prevent Permanent Prolonged ORAL Impairment/Damage Lortab C Levothyroxine C Kcl C Thiamine C Bisacodyl C Multi-Vit C Zoloft C Albuterol C Maalox C Mom C Nystatin C Protonix C Date:05/26/04ISR Number: 4366896-7Report Type:Direct Company Report #USP 56535 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Risperdal PS Janssen TABLET Risperdal SS Janssen Risperdal SS Janssen 22-Feb-2006 08:20 AM Page: 2095 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/04ISR Number: 4372396-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040502773 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Dysphagia Health (Risperidone) Professional Unspecified PS ORAL ORAL Haloperidol (Haloperidol) Unspecified SS ORAL ORAL Triheyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Vegetamin A (Vegetamin A) C Date:05/26/04ISR Number: 4372423-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040503084 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Recurrent Foreign Risperdal Hyperprolactinaemia Health (Risperidone)Unspeci Professional fied PS ORAL 2 MG, IN 1 DAY, ORAL Date:05/26/04ISR Number: 4372424-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040503071 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Disorder Foreign Risperdal Initial or Prolonged Health (Risperidone) PS ORAL ORAL Professional Date:05/26/04ISR Number: 4372425-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040303794 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Foreign Risperdal Hospitalization - Increased Health (Risperidone) PS ORAL 2 MG, 1 IN 1 Initial or Prolonged Aspartate Professional DAY, ORAL Aminotransferase Sodium Valproate Increased (Valproate Sodium) SS ORAL 400 MG, 1 IN Blood Creatine 1 DAY, ORAL Phosphokinase Increased Tiapride C-Reactive Protein Hydrochloried Decreased (Tiapride Convulsion Hydrochloride) Dementia Alzheimer'S Type Unspecified SS ORAL 100 MG, 1 IN Drug Effect Decreased 1 DAY, ORAL Hepatic Function Abnormal Flunitrazepam Hepatocellular Damage (Funitrazepam) Hyperkinesia Unspecified C Leukopenia Estazolam Neutropenia (Estazolam) Pneumonia Unspecified C Urinary Incontinence Chlorpromazine Hydrochloride (Chlorpromazine 22-Feb-2006 08:20 AM Page: 2096 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Biperiden Hydrochloride (Biperiden Hydrochloride3) C Date:05/26/04ISR Number: 4372426-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040502863 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Foreign Risperdal Hepatic Congestion Health (Risperidone) Right Ventricular Failure Professional Unspecified PS ORAL 4 MG, IN 1 Spleen Congestion DAY, ORAL Sudden Death Truxal Ventricular Hypertrophy (Chlorprothixene Hydrochloride) C Tavor (Lorazepam) C Timonil (Carbazepine) C Delix (Ramipril) C Ass (Acetylsalicylic Acid) C Dytide H (Dyazide) C Ismo (Isosorbide Moninitrate) C Date:05/26/04ISR Number: 4372427-8Report Type:Expedited (15-DaCompany Report #DK-JNJFOC-20040405479 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Foreign Risperdal Initial or Prolonged Pregnancy Health (Risperidone) Drug Withdrawal Syndrome Professional Unspecified PS INTRA-UTERINE 0.25 MG, IN 1 Neonatal DAY, Dyskinesia Neonatal INTRAUTERINE Hyperventilation Zoloft (Sertraline Irritability Hydrochloride) SS INTRA-UTERINE 150 MG, 1 IN Laryngomalacia 24 HOUR, Muscle Spasms INTRAUTERINE Respiratory Disorder Neonatal Tremor Date:05/26/04ISR Number: 4372428-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040503070 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pruritus Foreign Risperdal Renal Failure Health (Risperidone) Professional Unspecified PS ORAL 0.5 MG, ORAL; Company 0.5 MG, IN 1 Representative DAY, ORAL 22-Feb-2006 08:20 AM Page: 2097 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/04ISR Number: 4372648-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040504325 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:05/26/04ISR Number: 4372693-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040502786 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Dipiperon Initial or Prolonged Gingival Hyperplasia Health (Pipamperone) PS ORAL ORAL Tardive Dyskinesia Professional Risperdal (Risperidone) Unspecified SS ORAL ORAL .. SS Date:05/26/04ISR Number: 4372701-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040504226 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL 2 MG, 2 IN 1 Professional DAY, ORAL Date:05/26/04ISR Number: 4372702-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040504225 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Risperdal Congestive (Risperidone)Tablets PS ORAL 1.5 M, IN 1 DAY, ORAL Date:05/26/04ISR Number: 4372704-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040503812 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Risperdal Initial or Prolonged Dizziness Professional (Risperidone) PS Drug Abuser Company Dyspnoea Representative Date:05/26/04ISR Number: 4372705-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040504847 Age:78 YR Gender:Female I/FU:I Outcome PT Hospitalization - Cerebrovascular Accident Initial or Prolonged Dizziness Hallucination, Auditory Panic Attack Pollakiuria Somnolence 22-Feb-2006 08:20 AM Page: 2098 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal (Risperidone) Tablets PS ORAL ORAL Risperdal Consta (Risperidone) Microspheres SS 1 INJECTION ONLY Date:05/27/04ISR Number: 4366236-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040503910 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspartate Risperdal PS OROPHARINGEAL Hospitalization - Aminotransferase Initial or Prolonged Increased Blood Alkaline Phosphatase Increased Blood Lactate Dehydrogenase Increased Erythema Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Pruritus Date:05/27/04ISR Number: 4366237-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031102704 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Health Risperdal PS OROPHARINGEAL Consciousness Professional Risperdal SS OROPHARINGEAL Drug Level Increased Digoxin C 125mg + General Physical Health 62.5mg Deterioration Enalapril C Incontinence Warfarin C Respiratory Depression Bendrofluazide C UNKNOWN Date:05/27/04ISR Number: 4366238-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040503065 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Oculogyration Health Risperdal PS OROPHARINGEAL 903 DAY Sinus Arrhythmia Professional Risperdal SS OROPHARINGEAL 903 DAY Somnolence Risperdal SS OROPHARINGEAL 903 DAY Speech Disorder Trihexyphenidyl Tremor Hydrochloride C OROPHARINGEAL Nitrazepam C OROPHARINGEAL Levomepromazine Maleate C OROPHARINGEAL 5 DAY Zopiclone C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2099 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/04ISR Number: 4366239-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040503067 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lupus-Like Syndrome Health Risperdal PS OROPHARINGEAL Professional Date:05/27/04ISR Number: 4366240-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040401494 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Increased Red Blood Cell Sedimentation Rate Increased Date:05/27/04ISR Number: 4369040-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040505336 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:05/27/04ISR Number: 4369045-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040504842 Age:99 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional (Unspecified) PS ORAL ORAL Date:05/27/04ISR Number: 4369054-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040505340 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Consumer Risperdal Convulsion (Risperidone) Medication Error Unspecified PS ORAL 0.25 MG, 2 IN 1 DAY, ORAL Ativan (Lorazepam) C Paxil (Paroxetine Hydrochloride) C Trazodone (Trazodone) C Date:05/27/04ISR Number: 4369059-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040306060 Age:10 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Insulin-Dependent Professional (Risperidone) Pancreatic Insufficiency Company Unspecified PS 0.5 MG Representative Prozac (Fluoxetine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 2100 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/04ISR Number: 4370118-0Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040405310 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cryptogenic Organizing Foreign Risperdal Pneumonia Health (Risperidone) PS ORAL 0.75 MG, IN 1 Professional DAY, ORAL Company Representative Other Date:05/28/04ISR Number: 4367046-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040406512 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Risperdal PS OROPHARINGEAL Cardiac Arrest Tercian C UNKNOWN Respiratory Arrest Rivotril C UNKNOWN Somnolence Lepticur C Theralene C UNKNOWN Date:05/28/04ISR Number: 4367047-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040400577 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Face Oedema Risperdal Consta PS INTRAMUSCULAR Influenza Like Illness Jaundice Oedema Peripheral Date:05/28/04ISR Number: 4367048-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040505676 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Heart Disease Congenital Risperdal PS Maternal Drugs Affecting Foetus Date:05/28/04ISR Number: 4367049-9Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040205705 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Disorder Risperdal PS OROPHARINGEAL Pharmaceutical Product Tramal Sr C OROPHARINGEAL 100 gm daily Complaint (the patient Swelling Face has been on tramadol hydrochloride Norvasc C OROPHARINGEAL Zyprexa C OROPHARINGEAL 10 mg at night 22-Feb-2006 08:20 AM Page: 2101 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/28/04ISR Number: 4367050-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040503065 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Risperdal PS OROPHARINGEAL 903 DAY Oculogyration Risperdal SS OROPHARINGEAL 903 DAY Sinus Arrhythmia Risperdal SS OROPHARINGEAL 903 DAY Somnolence Trihexyphenidyl Speech Disorder Hydrochloride C OROPHARINGEAL Tremor Nitrazepam C OROPHARINGEAL Levomepromazine Maleate C OROPHARINGEAL 5 DAY Zopiclone C OROPHARINGEAL Date:05/28/04ISR Number: 4367051-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040506140 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperprolactinaemia Risperdal PS OROPHARINGEAL Initial or Prolonged Ovarian Cyst Risperdal SS OROPHARINGEAL Biperiden Hydrochloride C UNKNOWN Bromocriptine Mesylate C UNKNOWN Brotizolam C UNKNOWN Ethyl Loflazepate C UNKNOWN Diazepam C UNKNOWN Date:05/28/04ISR Number: 4368648-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20031102704 Age:94 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Depressed Level Of Foreign Risperdal Consciousness Health (Risperidone) Drug Level Increased Professional Tablets PS ORAL 0.5 MG, 2 IN1 General Physical Health DAY, ORAL Deterioration Digoxin (Digoxin) C Immobile Enalapril Incontinence (Enalapril) C Respiratory Depression Warfarin (Warfarin) C Bendrofluazide (Bendroflumethiazide ) C Date:05/28/04ISR Number: 4368649-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040503067 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lupus-Like Syndrome Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:05/28/04ISR Number: 4368651-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040401494 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Hospitalization - Inflammation Foreign Initial or Prolonged Health 22-Feb-2006 08:20 AM Page: 2102 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal Cosnta (Risperidone) Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:05/28/04ISR Number: 4368697-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040503065 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Foreign Risperdal Oculogyration Health (Risperidone) Sinus Arrhythmia Professional Unspecified PS ORAL SEE IMAGE Somnolence Trihexyphenidyl Speech Disorder Hydrochloride Tremor (Trihexyphenidyl Hydrochloride) C Nitrazepam (Nitrazepam) C Levomepromazine Maleate (Levomepromazine Maleate) C Zopiclone (Zopiclone) C Date:05/28/04ISR Number: 4368698-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040503910 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Alkaline Foreign Risperdal Hospitalization - Phosphatase Increased Health (Risperidone) Initial or Prolonged Blood Lactate Professional Tablets PS ORAL ORAL Dehydrogenase Increased Erythema Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Pruritus Date:05/28/04ISR Number: 4383001-1Report Type:Periodic Company Report #US-JNJFOC-20040102566 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperdal Consta Initial or Prolonged Schizophrenia Professional (Risperidone) Microspheres PS INTRAMUSCULAR , 1 IN 2 WEEK, INTRA-MUSCULA R 22-Feb-2006 08:20 AM Page: 2103 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/04ISR Number: 4367710-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040505442 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Risperdal Consta PS INTRAMUSCULAR Neutropenia Risperdal SS OROPHARINGEAL Date:06/01/04ISR Number: 4367711-8Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20040505717 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Risperdal PS OROPHARINGEAL Ventricular Fibrillation Setraline C Alprazolam C Zolpidem C Digoxin C Warfarin C Frumil C Frumil C Salomol C Date:06/01/04ISR Number: 4367712-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040301721 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Risperdal PS OROPHARINGEAL 99 DAY Initial or Prolonged Risperdal SS OROPHARINGEAL 99 DAY Other Flunitrazepam C OROPHARINGEAL Thioridazine Hydrochloride C OROPHARINGEAL Date:06/01/04ISR Number: 4367713-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040506559 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Risperdal Consta PS INTRAMUSCULAR Thrombocytopenia Orap SS OROPHARINGEAL Date:06/01/04ISR Number: 4367714-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040505344 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Risperdal PS OROPHARINGEAL Initial or Prolonged Fall Tranxene SS OROPHARINGEAL Malaise Levothyrox SS OROPHARINGEAL Depakote SS OROPHARINGEAL Date:06/01/04ISR Number: 4370965-5Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040205705 Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Disorder Foreign Risperdal Pharmaceutical Product Health (Risperidone) Complaint Professional Tablets PS ORAL 1 MG, 2 IN 1 Swelling Face DAY, ORAL Tramal Sr (Tramal Hydrochloride) 22-Feb-2006 08:20 AM Page: 2104 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sustained Release Tablets C Norvasc (Amlodipine Besilate) C Zyprexa (Olanzapine) C Date:06/01/04ISR Number: 4370968-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040503065 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Foreign Risperdal Oculogyration Health (Risperdal) Sinus Arrhythmia Professional Unspecified PS ORAL ORAL Somnolence Trihexyphenidyl Speech Disorder Hydrochloride Tremor (Trihexphenidyl Hydrcochloride) C Nitrazepam (Nitrazepam) C Levomepromazine Maleate (Levomepromazine Maleate) C Zopiclone (Zopiclone) C Date:06/01/04ISR Number: 4370970-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040506140 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperprolactinaemia Foreign Risperdal Initial or Prolonged Ovarian Neoplasm Health (Risperidone) Professional Unspecified PS ORAL 6 MG, IN 1 DAY, ORAL Biperiden Hydrochloride (Biperiden Hydrcholoride) C Bromocrioptine Mesylate (Bromocriptine) C Brotizolam (Brotizolam) C Ethyl Loflazepate (Ethyl Loflazepate) C Dizepam (Diazepam) C Date:06/01/04ISR Number: 4370973-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040505676 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Cardiac Disorder Foreign Risperdal Congenital Anomaly Health (Risperidone) PS INTRA-UTERINE 6 MG, IN 1 Drug Exposure During Professional DAY, Pregnancy INTRAUTERINE 22-Feb-2006 08:20 AM Page: 2105 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/01/04ISR Number: 4370975-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040406512 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anuria Foreign Risperdal Cardio-Respiratory Arrest Health (Risperidone) Heart Rate Increased Professional Tablets PS ORAL 4 MG, 2 IN 1 Somnolence Company DAY, ORAL Representative Tercian (Cyamemazine) C Lepticur (Tropatepine Hydrochloride) Tablets C Theralene (Alimemazine Tartrate) C Date:06/01/04ISR Number: 4370978-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040400577 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Foreign Risperdal Consta Face Oedema Health (Risperidone) Feeling Abnormal Professional Microsperes PS INTRAMUSCULAR 25 MG, 1 IN 2 Influenza Like Illness WEEK, Jaundice INTRA-MUSCLAR Muscular Weakness Oedema Peripheral Date:06/01/04ISR Number: 4370997-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040503065 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Discomfort Risperdal Oculogyration (Risperidone) PS ORAL SEE IMAGE Sinus Arrhythmia Trihexyphenidyl Somnolence Hydrochloride Speech Disorder (Trihexyphenidyl Tremor Hydrochloride) C Nitrazepam (Nitrazepam) C Levomepromazine Maleate (Levomepromazine Maleate) C Zopiclone (Zopiclone) C Date:06/02/04ISR Number: 4368554-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040405943 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Foreign Risperdal Consta Initial or Prolonged Drug Interaction Health (Risperidone) Electrocardiogram Qt Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Prolonged WEEK, Extrapyramidal Disorder INTRA-MUSCULA Qrs Axis Abnormal R 22-Feb-2006 08:20 AM Page: 2106 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal (Risperidone) Solution SS ORAL SEE IMAGE Lepticur (Tropatepine Hydrochloride) C Valium (Diazepam) C Date:06/02/04ISR Number: 4368556-5Report Type:Expedited (15-DaCompany Report #DK-JNJFOC-20040304836 Age:67 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Foreign Risperdal Initial or Prolonged Confusional State Health (Risperidone) Csf Oligoclonal Band Professional Tablets PS 1/2 TABLET X Present 2 Dementia Alzheimer'S Type Akineton (Biperiden Gait Disturbance Hydrochloride) C Memory Impairment Imovane (Zopiclone) C Sensory Disturbance Hexasoptin Strabismus (Verapamil) C Urinary Tract Infection Enterococcal Date:06/02/04ISR Number: 4368559-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040303065 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Foreign Risperdal Initial or Prolonged Asthenia Health (Risperidone) Dyspnoea Professional Tablets PS ORAL SEE IMAGE Herpes Simplex Company Tercian Pyrexia Representative (Cyamemazine) SS 2 MG, IN 1 DAY Lepticur (Tropatepine Hydrochloride) SS 10 MG, IN 1 DAY Rivotril (Clonazepam) C Date:06/02/04ISR Number: 4371691-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-2004056559 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Consta Thrombocytopenia Health Microspheres Professional (Risperidone) PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK , INTRA-MUSCULA R Orap (Pimozide) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 2107 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/04ISR Number: 4371694-4Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20040505717 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Risperdal Ventricular Fibrillation Health (Risperidone) PS ORAL 3 MG, IN 1 Professional DAY, ORAL Sertraline C Alprazolam C Zolpidem C Digoxin C Warfarin C Prumil C Salomol C Date:06/02/04ISR Number: 4371698-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040505344 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Foreign Risperdal Initial or Prolonged Fall Health (Risperidone) PS ORAL 3.5 MG, 1 IN Malaise Professional 1 DAY ORAL Tranxene (Clorazepate Dipotassium) SS ORAL 3.5 MG ORAL Levothyrox (Levothyroxine Sodium) SS ORAL 30 MG ORAL Depakote (Valproate Semisodium) SS ORAL 1 MG ORAL Date:06/02/04ISR Number: 4371702-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040301721 Age:61 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperdal Initial or Prolonged Malaise Health (Risperidone) Other Pancytopenia Professional Unspecified PS ORAL 2 MG, IN 1 DAY, ORAL : 3 MG, IN 1 DAY, ORAL Flunitrazepam C Thioridazine Hydrochloride C Date:06/02/04ISR Number: 4371822-0Report Type:Expedited (15-DaCompany Report #2004215021US Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Celebrex (Celecoxib) Electrocardiogram Qt Professional Capsule PS 100 MG, QD Corrected Interval Risperdal Electrocardiogram Qt (Risperidone) SS ORAL 3 MG, QD, Prolonged ORAL Hypotension Allegra Orthostatic Hypotension (Fexofenadine Hydrochloride) C Aspirin "Bayer" C Senokot-S (Docusate 22-Feb-2006 08:20 AM Page: 2108 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium, Senna) C Duragesic C Neurontin C Flonase (Fluticasone Propionate) C Medrol C Dilantin (Phenytoin Sodium) C Exelon (Rivastigmine Tartrate) C Date:06/02/04ISR Number: 4372295-4Report Type:Expedited (15-DaCompany Report #2004AP02335 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 100 MG TID PO Initial or Prolonged Increased Health Seroquel SS ORAL 100 MG DAILY Aspartate Professional PO Aminotransferase Other Lodopin SS ORAL 100 MG TID PO Increased Lodopin SS ORAL 100 MG DAILY Blood Alkaline PO Phosphatase Increased Risperdal SS ORAL 1 MG TID PO Blood Lactate Risperdal SS ORAL 1 MG DAILY PO Dehydrogenase Increased Tasmolin SS ORAL 3 MG DAILY PO Hepatic Function Abnormal Tasmolin SS ORAL 1 MG DAILY PO Weight Decreased Rohypnol SS Vegetamin SS Date:06/02/04ISR Number: 4372298-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040505442 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Consta Neutropenia Health (Risperidone) Professional Micropheres PS INTRAMUSCULAR 37.5 MG, 1 IN 14 DAY, INTRA-MUSCULA R Risperdal (Risperidone) Unspecified SS ORAL 4 MG, ORAL Date:06/02/04ISR Number: 4372309-1Report Type:Expedited (15-DaCompany Report #04P-062-0261691-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Drug Overdose Foreign Akineton (Biperiden) Initial or Prolonged Intentional Health (Biperiden) PS ORAL 140 MG, ONCE, Mydriasis Professional PER ORAL Sopor Zolpidem SS ORAL 100 MG, ONCE, Suicidal Ideation PER ORAL Tachycardia Citalopram Hydrobromide SS ORAL 180 MG, ONCE, PER ORAL Risperidone SS ORAL 40 MG, ONCE, PER ORAL Prothipendyl Hydrochloride SS ORAL 1320 MG, ONCE, PER 22-Feb-2006 08:20 AM Page: 2109 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Isopromethazine Hydrochloride SS ORAL 250 MG, ONCE, PER ORAL Akineton (Biperiden) (Biperiden) C Zolpidem C Citalopram Hydrobromide C Risperidone C Prothipendyl Hydrochloride C Isopromethazine Hydrochloride C Date:06/03/04ISR Number: 4370422-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12498341 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Abilify PS Otsuka Initial or Prolonged Neuroleptic Malignant Pharmaceutical Other Syndrome Company, Ltd. ORAL 2 DAY Seroquel SS Risperdal SS Effexor C Date:06/03/04ISR Number: 4371292-2Report Type:Expedited (15-DaCompany Report #2004215047US Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bipolar Disorder Health Xanax (Alprazolam) Completed Suicide Professional Tablet PS Condition Aggravated Solu-Medrol Depression (Methylprednisolone) Multiple Sclerosis Powder, Sterile SS INTRAVENOUS 44 UG, 3 IN 1 Vision Blurred WEEK, IV Rebif (Interferon Beta) SS SUBCUTANEOUS 44 MG 3 IN 1 WEEK, SUBCUTANEOUS Risperidone (Risperidone) SS Date:06/03/04ISR Number: 4373365-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040505751 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Health Risperdal Consta Professional (Risperidone) Company Microspheres PS ORAL ORAL Representative Date:06/03/04ISR Number: 4373370-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031101049 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Death Death Consumer Health 22-Feb-2006 08:20 AM Page: 2110 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal (Risperidone) PS 3 MG, 2 IN 1 DAY Artane (Trihexyphenidyl Hydrochloride) C Lotensin (Benazepril Hydrochloride) C Hctz (Hydrochlorothiazide ) C Humulin 70/30 (Human Mixtard) C Aspirin (Acetylsalicylic Acid) C Date:06/03/04ISR Number: 4375114-5Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20040506537 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lymphocyte Count Foreign Risperdal Decreased Health (Risperidone) PS ORAL 1 MG, ORAL Myalgia Professional Neutrophil Count Increased Pain Pyrexia Date:06/03/04ISR Number: 4375116-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040506536 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pyrexia Foreign Risperdal Respiratory Arrest Health (Risperidone) PS ORAL 3 MG, 1 IN 1 Professional DAY, ORAL Company Sevredol (Morphine Representative Sulfate) C Other Athymil (Mianserin Hydrochloride) C Lexomil (Bromazepam) C Noctran (Noctran 10) C Glucophage (Metformin Hydrochloride) C Diamicron (Gliclazide) C Cozaar (Losartan Potassium) C Loxen (Nicardipine Hydrochloride) C Dafalgan (Paracetamol) C Sulfarlem (Anethole Trithione) C Nifluril 22-Feb-2006 08:20 AM Page: 2111 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Niflumic Acid) C Kardegic (Acetylsalicylate Lysine) C Rhinofluimucil (Rhinofluimucil) C Cold Cream Naturel (Cold Cream) C Date:06/03/04ISR Number: 4375118-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040506541 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Risperdal Corrected Interval Health (Risperidone) PS ORAL ORAL Prolonged Professional Date:06/03/04ISR Number: 4375122-4Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040400849 Age: Gender:Not SpecifiI/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Disease Recurrence Foreign Risperdal Emotional Disorder Health (Risperidone) PS ORAL 1 MG, IN 1 Movement Disorder Professional DAY, ORAL Date:06/03/04ISR Number: 4375124-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040403929 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Foreign Risperdal Rhabdomyolysis Health (Risperidone) PS ORAL 4 MG, 1 IN 1 Professional DAY, ORAL Date:06/03/04ISR Number: 4375125-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040305726 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Toxic Epidermal Foreign Risperdal Necrolysis Health (Risperidone) PS ORAL ORAL Professional Psychotropic Agents (Antipsychotics) C Vegetamin (Vegetamin) C Date:06/03/04ISR Number: 4375127-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040205723 Age:93 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Foreign Reminyl Bradyarrhythmia Health (Galantamine) PS ORAL 8 MG, ORAL Drug Ineffective Professional Risperdal Drug Interaction (Risperidone) General Physical Health Tablets SS ORAL 1 MG, ORAL Deterioration Seloken (Metoprolol Overdose Tartrate) Unknown SS ORAL 50 MG, ORAL Speech Disorder Ebixa (Memantine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 2112 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hemigoxine (Digoxin) C Mopral (Omeprazole) C Imovane (Zopiclone) C Triflucan (Fluconazole) C Date:06/04/04ISR Number: 4371711-1Report Type:Direct Company Report #CTU 220164 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Risperdal PS 17 MON Dyspnoea General Physical Health Deterioration Legal Problem Date:06/04/04ISR Number: 4374134-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040600333 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL 0.5 MG, 4 IN Professional 1 DAY, ORAL Date:06/04/04ISR Number: 4374151-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040506875 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematuria Health Risperdal Initial or Prolonged Urinary Tract Infection Professional (Risperidone) PS ORAL 2 MG, 2 IN 1 DAY, ORAL Lortab (Vicodin) C Docusate (Docusate) C Bisacodyl (Bisacodyl) C Date:06/04/04ISR Number: 4374159-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040600038 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypertension Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Date:06/04/04ISR Number: 4374738-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040505676 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Atrial Septal Defect Foreign Risperdal Drug Exposure During Health (Risperidone) PS INTRA-UTERINE 6 MG, IN 1 Pregnancy Professional DAY, INTRAUTERINE Biperiden Hydrochloride (Biperiden 22-Feb-2006 08:20 AM Page: 2113 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Flunitrazepam (Flunitrazepam) C Date:06/04/04ISR Number: 4374741-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040404032 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Foreign Risperdal Unconjugated Increased Health (Risperidone) PS ORAL SEE IMAGE Coagulation Factor V Professional Level Decreased Prothrombin Time Shortened Date:06/04/04ISR Number: 4374989-3Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040502116 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Risperidone Initial or Prolonged Anxiety Health (Risperidone) Mood Altered Professional Microspheres PS INTRAMUSCULAR SEE IMAGE Psychotic Disorder Risperdal (Risperidone) C Promethazine (Promethazine) Tablets C Oxazepamum (Oxaxepam) Tablets C Date:06/07/04ISR Number: 4375703-8Report Type:Expedited (15-DaCompany Report #6008954 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ammonia Increased Foreign Levothyrox 100 Initial or Prolonged Bundle Branch Block Right Health (Tablets) Fall Professional (Levothyroxine Malaise Other Sodium) PS ORAL 1 DOSAGE FORMS (1 DOSAGE FORMS, 1 IN 1 D) ORAL Risperdal (Risperidone) SS ORAL 3, 5 MG ORAL Depakote (Valproate Semisodium) SS ORAL 1 GM ORAL Tranxene (10 Mg, Capsules) (Clorazepate Dipotassium) SS ORAL 30 MG (10 MG, 3 IN 1 D) ORAL 22-Feb-2006 08:20 AM Page: 2114 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/10/04ISR Number: 4378668-8Report Type:Expedited (15-DaCompany Report #139052USA Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Pimozide PS ORAL Professional Risperidol Consta SS INTRAMUSCULAR Date:06/10/04ISR Number: 4378866-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040502786 Age:6 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Gingival Hyperplasia Health (Risperidone) PS ORAL 0.5 MG, IN 1 Tardive Dyskinesia Professional DAY, ORAL Dipiperon (Pipamperone) SS ORAL Date:06/10/04ISR Number: 4379111-5Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040601256 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Foreign Risperidone Initial or Prolonged Hallucination Literature (Risperidone) Leukopenia Health Unspecified PS ORAL 2 MG, 1 IN 1 Muscle Rigidity Professional DAY, ORAL Neutropenia Pneumonia Date:06/10/04ISR Number: 4379169-3Report Type:Expedited (15-DaCompany Report #NSADSS2003024184 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Interaction Study Procrit Initial or Prolonged Alcohol Use Health (Erythropoietin) Convulsion Professional Unspecified PS 4000 IU, 1 IN Drug Interaction 1 WEEK Haemoglobin Decreased Celexa (Citalopram Hydrobromide) SS Risperdal (Risperidone) SS Combivir (Zidovudine W/Lamivudine) C Kaletra (Kaletra) C Date:06/10/04ISR Number: 4379174-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040600908 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 0.25 MG, 1 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 2115 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/10/04ISR Number: 4379179-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040600971 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomyopathy Consumer Risperdal (Risperidone) Unspecified PS Date:06/10/04ISR Number: 4379180-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040600924 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Risperdal Congestive (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY , ORAL Date:06/10/04ISR Number: 4379181-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040601513 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL 0.25 MG, ORAL Date:06/10/04ISR Number: 4379228-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040600417 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lung Infection Foreign Risperdal Initial or Prolonged Myxoedema Coma Health (Risperidone) Professional Tablets PS ORAL SEE IMAGE Company Xanax (Alprazolam) C Representative Levothyrox (Levothyroxine Sodium) C Date:06/12/04ISR Number: 4376369-3Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040601098 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal PS Initial or Prolonged Hyperprolactinaemia Risperdal SS Cilest SS Date:06/14/04ISR Number: 4377176-8Report Type:Direct Company Report #CTU 220640 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hair Growth Abnormal Risperdal .5 Mg PS ORAL 1 MG IN AM 2 MG IN PM ORAL Geodon 20 Mg SS ORAL 20 MG IN AM AND ORAL Geodon C Lamictal C Klonopin C Abilify C 22-Feb-2006 08:20 AM Page: 2116 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Topamax C Clonidine C Seroquel C Trileptal C Depakote C Lithium C Zyprexa C Date:06/14/04ISR Number: 4377287-7Report Type:Direct Company Report #CTU 220620 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Blood Prolactin Increased Risperdal .25 Mg PS ORAL .25 MG 4 Intervention to Endocrine Disorder TIMES/D ORAL; Prevent Permanent Growth Accelerated NO .25 ONLY Impairment/Damage Insulin Resistance 1/DAY Pollakiuria Topamax C Precocious Puberty Weight Increased Date:06/14/04ISR Number: 4379882-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040505676 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Atrial Septal Defect Foreign Risperdal Drug Exposure During Health (Risperidone) Pregnancy Professional Unspecified PS INTRA-UTERINE 6 MG, IN 1 DAY, INTRAUTERINE Biperiden Hydrochloride (Unknown) (Biperiden Hydrochloride) C Flunitrazepam (Flunitrazepam) Unknown C Date:06/14/04ISR Number: 4379883-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040504990 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Foreign Risperidone Drug Exposure During Health (Risperidone) Pregnancy Professional Unspecified PS ORAL 1 MG, ORAL; 1.5 MG, ORAL, 2 MG, ORAL; 2.5 MG, ORAL; 1 MG ORAL Risperidone (Risperidone) Tablets SS ORAL 2 MG, ORAL; 1 MG, ORAL; 0.5 MG, 2 IN 1 DAY, ORAL; 2 MG, ORAL; 4 Bromperidol (Unspecified) Bromperidol C 22-Feb-2006 08:20 AM Page: 2117 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Biperiden (Unknown) Biperiden C Haloperidol (Haloperidol) Injection C Haloperidol (Haloperidol) Unspecified C Haloperidol (Haloperidol) Injection C Diazepam (Diazepam) Unknown C Chlorpromazine (Chlorpromazine) C Promethazine (Promethazine) Unknown C Date:06/14/04ISR Number: 4379884-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040602009 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Steatosis Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 6 MG, IN 1 DAY, ORAL Quazepam (Unknown) Quazepam C Sennoside (Unknown) All Other Therapeutic Products) Unknown C Haloperidol (Haloperidol) Unspecified) C Lorazepam (Lorazepam) Unknown C Biperiden Hydrochloride (Biperiden Hydrochloride) C Lormetazepam (Lormetazepam) Unknown C Date:06/14/04ISR Number: 4379889-0Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040601098 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Risperdal Initial or Prolonged Hyperprolactinaemia Consumer (Risperidone) Health Tablets PS 1 MG, 2 IN 1 Professional DAY; 1.5 MG, 1 IN 1 DAY Cilest (Norgestimate/Ethiny l Estradiol) Tablets SS 1 DOSE (S), 1 IN 1 CYCLICAL 22-Feb-2006 08:20 AM Page: 2118 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/04ISR Number: 4379965-2Report Type:Expedited (15-DaCompany Report #EMADSS2003000947 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Foreign Risperdal Prolonged Health (Risperidone) Extrapyramidal Disorder Professional Tablets PS ORAL 0.25 MG, ORAL Frusene (Furesis Comp) C Date:06/14/04ISR Number: 4379966-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040601724 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Risperdal Increased Health (Risperidone) Haemoglobin Decreased Professional Unspecified PS ORAL SEE IMAGE Protein Total Decreased Levomepromazine Red Blood Cell Count Maleate Decreased (Levomepromazine Tremor Maleate) C Date:06/14/04ISR Number: 4379968-8Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20040400876 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumonia Foreign Risperidone Initial or Prolonged Confusional State Health (Risperidone) Depressed Level Of Professional Unspecified PS ORAL 0.25 MG, 1 IN Consciousness 1 DAY, ORAL Enteritis Glucophage Gastrointestinal Disorder (Metformin Pyrexia Hydrochloride) Unknown SS 1000 MG, IN 1 DAY Humulin (Novolin 20/80) Injection SS SUBCUTANEOUS 24 IU, IN 1 DAY, SUBCUTANEOUS Humalog (Insulin Lispro) Injection SS SUBCUTANEOUS 24 IU, IN 1 DAY, SUBCUTANEOUS Date:06/14/04ISR Number: 4380030-9Report Type:Expedited (15-DaCompany Report #2004037151 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Overdose Foreign Diphenhydramine Health (Diphenhydramine) PS ORAL ORAL Professional Risperidone (Risperidone) SS OPHTHALMIC ORAL 22-Feb-2006 08:20 AM Page: 2119 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/04ISR Number: 4380053-XReport Type:Expedited (15-DaCompany Report #DSA_24479_2004 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Foreign Tavor PS Initial or Prolonged Loss Of Consciousness Health Mst SS Required Miosis Professional Risperdal SS Intervention to Multiple Drug Overdose Other Prevent Permanent Intentional Impairment/Damage Date:06/14/04ISR Number: 4380372-7Report Type:Expedited (15-DaCompany Report #2004030086 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Hydroxyzine Initial or Prolonged Drug Exposure During Literature Hydrochloride Pregnancy Health (Tablet) Pregnancy Professional (Hydroxyzine Psychotic Disorder Hydrochloride) PS 12.5 MG (4 Thrombophlebitis WK) Alprazolam (Alprazolam) (Alprazolam) SS Ampicllin/Sulbactam (Ampicillin, Sulbactam) SS Mirtazapine (Mirtazapine) SS Risperidone (Risperidone) SS Fluvoxamine (Fluvoxamine) SS Quetiapine (Qetiapine) C Diazepam (Diazepam) C Thioridazine (Thioridazine) C Carbamazepine (Carbamazepine) C Biperien (Biperien) C Troxerutin (Troxerutin) C Enoxaparin (Heparin) C Date:06/15/04ISR Number: 4377633-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB02356 Age:49 YR Gender:Male I/FU:I Outcome PT Other Aggression Agitation Body Temperature Increased Confusional State Dizziness Drug Withdrawal Syndrome Dysphagia Hyperhidrosis Hypotension Malaise 22-Feb-2006 08:20 AM Page: 2120 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Rigidity Musculoskeletal Stiffness Neuroleptic Malignant Report Source Product Role Manufacturer Route Dose Duration Syndrome Clozaril PS Novartis Sector: Pain Pharma ORAL 150mg nocte Refusal Of Examination and 125mg Restlessness mane Salivary Hypersecretion Risperidone SS Tachycardia Throat Tightness Date:06/15/04ISR Number: 4377702-9Report Type:Expedited (15-DaCompany Report #PHRM2004FR01445 Age:89 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Exelon PS Novartis Sector: Initial or Prolonged Pharma ORAL 3 mg, BID 76 DAY Other Risperdal SS ORAL 2 mg/day then 1 mg/day Date:06/15/04ISR Number: 4381701-0Report Type:Expedited (15-DaCompany Report #2004212920JP Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Halcion Initial or Prolonged Phosphokinase Increased Health (Triazolam)Tablet PS ORAL 0.125 MG/DAY, Professional ORAL Other Risperdal (Risperidone) SS ORAL 1 MG/DAY, ORAL Depas (Etizolam) C Sigmart (Nicorandil) C Cardenalin C Pletaal C Juvela Nicotinate (Tocopheryl Nicotinate) C Methycobal (Mecobalamin) C Date:06/15/04ISR Number: 4381730-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040501597 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Risperdal Congestive (Risperidone) Unspecified PS ORAL ORAL Date:06/15/04ISR Number: 4381736-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040602345 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 0.25 MG , 1 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 2121 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/04ISR Number: 4381743-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040602341 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 0.5 MG, ORAL Date:06/15/04ISR Number: 4381889-1Report Type:Expedited (15-DaCompany Report #04P-056-0262745-00 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Depakote Tablets Initial or Prolonged Hypotension Health (Depakote) Malaise Professional (Divalproex Sodium) (Divalproex Sodium) PS ORAL 1000 MG, 1 IN 1 D, PER ORAL Clorazepate Dipotassium SS 30 MG, 1 IN 1 D, PER ORAL Risperidone SS ORAL 3.5 MG, 1 IN 1 D, PER ORAL Levothyroxine Sodium SS ORAL 100 MCG, 1 IN 1 D, PER ORAL Date:06/16/04ISR Number: 4381309-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040602672 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:06/17/04ISR Number: 4381218-3Report Type:Direct Company Report #CTU 221007 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anxiety Risperdal Injection PS 2 WK Disability Dyspnoea INJECTION Required Fatigue Intervention to Feeling Abnormal Prevent Permanent Gait Disturbance Impairment/Damage Insomnia Movement Disorder Respiration Abnormal Rhinitis Speech Disorder Tooth Discolouration Weight Increased Date:06/17/04ISR Number: 4381295-XReport Type:Direct Company Report #CTU 220952 Age:90 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Bullous Quinapril PS Initial or Prolonged Dyspnoea Risperdal SS Rash 22-Feb-2006 08:20 AM Page: 2122 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/04ISR Number: 4382682-6Report Type:Expedited (15-DaCompany Report #EMADSS2003000947 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Risperdal Electrocardiogram Qt Health (Risperidone) Prolonged Professional Tablets PS ORAL 0.25 MG, ORAL Frusene (Furesis Comp) C Date:06/17/04ISR Number: 4382684-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040602239 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Body Temperature Foreign Risperdal Increased Literature (Risperidone) PS ORAL SEE IMAGE Psychomotor Hyperactivity Health Haldol (Haloperidol) Pulmonary Thrombosis Professional Injection SS INTRAVENOUS SEE IMAGE Stupor Date:06/18/04ISR Number: 4380616-1Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0335563A Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Consumer Augmentin PS Glaxosmithkline ORAL 5 DAY Initial or Prolonged Disorientation Solupred SS Glaxosmithkline ORAL 5 DAY Risperdal SS ORAL 5 DAY Lasilix C Glaxosmithkline ORAL 40MG Per day YR Previscan C ORAL .25UNIT Per day YR Digoxine C Glaxosmithkline ORAL 1UNIT Per day YR Date:06/18/04ISR Number: 4380725-7Report Type:Expedited (15-DaCompany Report #PHNU2004DE01959 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cough Leponex / Clozaril Dyspnoea (Clozapine) PS Novartis Sector: Life Support Pharma ORAL Malignant Histiocytosis Risperdal SS Pneumonitis Pulmonary Fibrosis Suicide Attempt Date:06/18/04ISR Number: 4383129-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031102715 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Study Risperidone Weight Increased Health (Risperidone) Professional Unspecified PS Olanzapine (Olanzapine) SS Quetiapine (Quetiapine) SS Ziprasidone (Ziprasidone) SS Perphenazine 22-Feb-2006 08:20 AM Page: 2123 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Perphenazine) SS Date:06/18/04ISR Number: 4383131-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040602470 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Risperdal Initial or Prolonged Cerebral Atrophy (Risperidone) Condition Aggravated Tablets PS ORAL 2 MG, 1 IN, Fall ORAL Fatigue Requip (Ropinirole Hallucination Hydrochloride) C Medication Error Sinemet C Neuropathy Neurontin Parkinson'S Disease (Gabapentin) C Rhabdomyolysis Terazosin C Syncope Urinary Incontinence Date:06/18/04ISR Number: 4383327-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040603402 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Increased Foreign Risperdal Health (Risperidone) PS ORAL 6 MG, 1 IN 1 Professional DAY, ORAL Nitrazepam (Nitrazepam) C Amobarbital (Amobarbital) C Bromvalerylurea (Bromisoval) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Date:06/18/04ISR Number: 4383331-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040203134 Age:39 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Steatosis Foreign Risperdal Hepatosplenomegaly Health (Risperidone) PS ORAL 4 MG, IN 1 Thrombocytopenia Professional DAY, ORAL Bio Selenium + Zinc (Selenium Sulfide) C Date:06/18/04ISR Number: 4383600-7Report Type:Expedited (15-DaCompany Report #2004-BP-01620BP Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Consumer Aggrenox Capsules Initial or Prolonged Diabetic Ulcer (Asasantin) PS ORAL SEE TEXT (SEE Foot Amputation TEXT), PO Tremor Risperdol SS 0.5 MGX2, TX WAS INITIATED IN MAR/APR03 Depakote (Valproate 22-Feb-2006 08:20 AM Page: 2124 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Semisodium) SS 750 MG (25 MG/200 MG) (1 CAPSULE BID), TX WAS INITIATED IN Prilosec (Omeprazole) C Zoloft C Avandia C Date:06/21/04ISR Number: 4383924-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040602740 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Risperdal Initial or Prolonged Circulatory Collapse Health (Risperidone) Tricuspid Valve Professional Solution PS ORAL 4 MG, IN 1 Incompetence Company DAY, ORAL Ventricular Extrasystoles Representative Ventricular Hypertrophy Date:06/21/04ISR Number: 4383930-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040602860 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Cleft Lip And Palate Foreign Risperdal Congenital Anomaly Health (Risperidone) Drug Exposure During Professional Unspecified PS INTRA-UTERINE 3 MG, IN 1 Pregnancy Company DAY, Representative INTRA-UTERINE Date:06/21/04ISR Number: 4383936-XReport Type:Expedited (15-DaCompany Report #ES-JNJFOC-20040503488 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Risperdal Consta Initial or Prolonged Delirium Study (Risperidone) Disorientation Health Microspheres PS INTRAMUSCULAR SEE IMAGE Suicide Attempt Professional Biperiden Company (Biperiden) C Representative Clonacepan (Clonazepam) C Date:06/21/04ISR Number: 4383940-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040602430 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congenital Anomaly Foreign Risperdal Initial or Prolonged Drug Exposure During Health (Risperidone) Congenital Anomaly Pregnancy Professional Tablets PS INTRA-UTERINE 4 DOSE (S), Drug Interaction IN 1 DAY, Dystonia INTRA-UTERINE Ear Malformation Depamide Facial Dysmorphism (Valpromide) SS INTRA-UTERINE 1200 MG, IN 1 Hypotonia Neonatal DAY, Lip Disorder INTRAUTERINE Poor Sucking Reflex Valium (Diazepam) C Trandate (Labetalol 22-Feb-2006 08:20 AM Page: 2125 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride) C Date:06/21/04ISR Number: 4383942-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040602027 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebellar Syndrome Foreign Risperdal Initial or Prolonged Drug Interaction Health (Risperidone) Eye Disorder Professional Tablets PS ORAL ORAL Intention Tremor Laroxyl (Amitriptyline Hydrochloride) SS ORAL ORAL Bisoprolol (Bisoprolol) C Date:06/21/04ISR Number: 4383943-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040602019 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Risperdal Initial or Prolonged Drug Interaction Health (Risperidone) Systemic Lupus Professional Tablets PS ORAL 2 MG, IN 1 Erythematosus DAY, ORAL Tercian (Cyamemazine) SS ORAL Prozac (Fluoxetine Hydrochloride) C Temesta (Lorazepam) C Date:06/21/04ISR Number: 4383949-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040602725 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Risperdal Initial or Prolonged Self-Medication Health (Risperidone) Professional Unspecified PS ORAL ORAL Loxapac (Loxapine Succinate) C Date:06/21/04ISR Number: 4383964-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040201562 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Application Site Swelling Foreign Risperdal Consta Initial or Prolonged Benign Neoplasm Health (Risperidone) Fat Necrosis Professional Microspheres PS INTRAMUSCULAR SEE IMAGE Histology Abnormal Date:06/21/04ISR Number: 4384023-7Report Type:Expedited (15-DaCompany Report #DSA_24392_2004 Age:60 YR Gender:Female I/FU:I Outcome PT Hospitalization - Coma Initial or Prolonged Multiple Drug Overdose Intentional Somnolence White Blood Cell Count 22-Feb-2006 08:20 AM Page: 2126 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Tavor PS Health Akineton SS Professional Atosil SS Other Dominal "Asta" SS Asta Remergil SS Risperdal SS Zopiclone SS Flunitrazepam SS Date:06/21/04ISR Number: 4384063-8Report Type:Expedited (15-DaCompany Report #FR-2004-027011 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradycardia Foreign Sotalol (Sotalol Hospitalization - Cerebrovascular Accident Health Hydrochloride) Initial or Prolonged Coma Professional Tablet PS ORAL 40 MG/D, ORAL Hyponatraemia Other Risperdal (Risperidone) SS ORAL 1 TAB(S) PER DAY, ORAL Reminyl /Unk/(Galantamine) SS ORAL 16 MG/D, ORAL Date:06/21/04ISR Number: 4384934-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040602991 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL ORAL Professional Date:06/21/04ISR Number: 4384936-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040603002 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS Professional Date:06/21/04ISR Number: 4384942-1Report Type:Expedited (15-DaCompany Report #NSADSS2003002283 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, 1 IN 1 DAY, ORAL Date:06/22/04ISR Number: 4383466-5Report Type:Direct Company Report #CTU 221216 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal 1 Mg And 0.5 Mg PS ORAL 1.5 MG PO Q 22-Feb-2006 08:20 AM Page: 2127 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report HS Date:06/22/04ISR Number: 4385540-6Report Type:Expedited (15-DaCompany Report #2004-BP-03025BP Age:75 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Health Catapres Tts Initial or Prolonged Blood Pressure Increased Professional (Clonidine Delusional Disorder, Hydrohcloride) PS TOPICAL 0.3 MG (7.5 Persecutory Type MG), TO Depressive Symptom Risperdal (Risperidone) SS 2 MG (NR), NR Date:06/23/04ISR Number: 4383995-4Report Type:Direct Company Report #CTU 221285 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Risperidone PS ORAL 2 MG X BID, ORAL Date:06/23/04ISR Number: 4384993-7Report Type:Direct Company Report #CTU 221389 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Risperdal 2 Mg PS ORAL 2 MG PO QHS Initial or Prolonged Oedema Peripheral Prozac C Trazodone C Date:06/23/04ISR Number: 4386263-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040400845 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Foreign Risperdal Health (Risperidone) PS ORAL 2 MG, 1 IN 1 Professional DAY, ORAL Halomouth (Haloperidol Decanoate) Injection SS INTRAMUSCULAR 150 MG, IN 2 WEEK, INTRAMUSCULAR Psychotropic Agents (Antipsychotics) C Date:06/23/04ISR Number: 4386268-9Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040405310 Age:73 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cryptogenic Organizing Foreign Risperdal Pneumonia Health (Risperidone) PS ORAL 0.75 MG, IN Professional 1 DAY, ORAL Company Representative 22-Feb-2006 08:20 AM Page: 2128 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/04ISR Number: 4386430-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040503071 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pathogen Resistance Foreign Risperdal Initial or Prolonged Pulmonary Radiation Health (Risperidone) PS ORAL ORAL Injury Professional Hldol (Haloperidol) C Tercian (Cyamemazine) C Laroxyl (Amitripytline Hydrochloride) C Valium (Diazepam) C Mopral (Omeprazole) C Levothyrox (Levothyroxine Sodium) C Gaviscon (Gaviscon) C Movicol (Nulytely) C Date:06/23/04ISR Number: 4386432-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040604387 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Consta Professional (Risperidone) Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:06/24/04ISR Number: 4385091-9Report Type:Direct Company Report #CTU 221435 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Risperdal Consta 25 Mg PS INTRAMUSCULAR 25 MG Q 2 WEEKS IM Depakote C Risperidone C Benztropine C Lorazepam C Date:06/24/04ISR Number: 4388769-6Report Type:Expedited (15-DaCompany Report #K200400882 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Altace Capsules Initial or Prolonged Hypotension Health (Ramipril) Capsule, Malaise Professional 5 Mg PS ORAL 5 MG, QD, Other ORAL Corvasal (Molsidomine) Tablet, 12mg SS ORAL 12 MG, QD, ORAL Lasix (Furosemide) Tablet, 40mg SS ORAL 40 MG, QD, ORAL Detensiel 22-Feb-2006 08:20 AM Page: 2129 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Bisoprolol) Tablet, 10mg SS ORAL SEE IMAGE Risperdal (Riseperidone ) Tablet, 1mg SS ORAL SEE IMAGE Trinipatch (Glyceryl Trinitrate 10mg SS TRANSDERMAL 10 MG, QD, TRANSDERMAL Date:06/25/04ISR Number: 4388456-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040604604 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Tablets PS ORAL ORAL Date:06/25/04ISR Number: 4388507-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040405381 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Date:06/25/04ISR Number: 4388509-0Report Type:Expedited (15-DaCompany Report #US-JNFOC-20040503261 Age:79 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Cancer Metastatic Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Prilosec (Omeprazole) C Aspirin (Acetylsalicylic Acid) C Actonel (Risendronate Sodium) C Lopressor (Metoprolol Tartrate) C Paxil (Paroxetine Hydrochloride) C Dyazide (Dyazide) C Depakote (Valproate Semisodium) C Bextra (Bucindolol Hydrochloride) C Norvasc (Amlodipine Besilate) C Xanax (Alprazolam) C 22-Feb-2006 08:20 AM Page: 2130 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/04ISR Number: 4388511-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040604288 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.25 MG, 1 IN 1 DAY, ORAL Date:06/25/04ISR Number: 4388513-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040604393 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL Date:06/25/04ISR Number: 4388514-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040604598 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS Date:06/25/04ISR Number: 4388536-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040401553 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abasia Foreign Risperdal Consta Abnormal Behaviour Health (Risperidone) Agitation Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Aphagia WEEK, Aphasia INTRAMUSCULAR Blood Creatine Increased Risperidone Blood Creatine (Risperidone) C Phosphokinase Increased Blood Pressure Diastolic Increased Blood Pressure Increased Confusional State Drooling Drug Toxicity Dysarthria Dyskinesia Emotional Distress Feeling Abnormal Hostility Hypotonia Incoherent Neutrophil Count Increased Post Procedural Complication Posture Abnormal Psychotic Disorder Refusal Of Treatment By Patient Treatment Noncompliance 22-Feb-2006 08:20 AM Page: 2131 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/04ISR Number: 4388539-9Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040502104 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Leg Amputation Foreign Risperdal Other Vasculitis Health (Risperidone) Professional Unspecified PS Date:06/25/04ISR Number: 4388540-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040602726 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Faecal Incontinence Foreign Risperdal Initial or Prolonged Feeling Drunk Consumer (Risperidone) Disability Gait Disturbance Unspecified PS 1 MG, 2 IN 1 Hallucination DAY Muscle Rigidity Urinary Incontinence Weight Increased Date:06/25/04ISR Number: 4388541-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040603725 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Tongue Oedema Foreign Risperdal Hospitalization - Health (Risperidone) Initial or Prolonged Professional Unspecified PS ORAL ORAL Date:06/28/04ISR Number: 4385443-7Report Type:Expedited (15-DaCompany Report #PHBS2004ES08155 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Trileptal PS Novartis Sector: Initial or Prolonged Asthenia Professional Pharma ORAL 600 mg/d 25920MIN Sleep Apnoea Syndrome Depakine SS ORAL 1 g/d 25920MIN Somnolence Risperdal SS ORAL 3 ml/d 25920MIN Seroquel SS ORAL 400 mg/d 25920MIN Deprax SS ORAL 100 mg/d 25920MIN Seroxat "Smithkline Beecham" SS ORAL 40 mg/d 25920MIN Date:06/28/04ISR Number: 4385593-5Report Type:Expedited (15-DaCompany Report #PHRM2004FR01932 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Exelon PS Novartis Sector: Professional Pharma ORAL 1.5 mg, BID Risperdal SS ORAL 1.5 mg/day Atarax C ORAL 12.5 mg/day Stilnox C ORAL 10 mg/day Deroxat C 20 mg/day 22-Feb-2006 08:20 AM Page: 2132 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/28/04ISR Number: 4386217-3Report Type:Direct Company Report #CTU 221645 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Haematocrit Decreased Divalproex 1250mg PS 1250MG PO Q Initial or Prolonged Haemoglobin Decreased HS Risperidone 2mg SS ORAL 2MG PO QHS Aspirin C Clotrimazole C Diphenhydramine C Folic Acid C Ibuprofen C Insulin Nph C Lisinopril C Multivitamin C Magnesium Hydroxide C Nicotine Patch C Omeprazole C Thiamine C Trazadone C Date:06/28/04ISR Number: 4389488-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040404523 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Immobile Foreign Risperdal Initial or Prolonged Lethargy Health (Risperidone) Oedema Peripheral Professional Solution PS ORAL 0.5, 1, 3 MG, Phlebitis Company IN 1 DAY, Salivary Hypersecretion Representative ORAL Thrombosis Reminyl (Galantamine) Unspecified SS ORAL 8 - 16 MG, IN 1 DAY, ORAL Date:06/28/04ISR Number: 4389525-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040602239 Age:29 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiovascular Disorder Foreign Risperdal Coma Literature (Risperidone) PS ORAL SEE IMAGE Psychomotor Hyperactivity Health Haldol (Haloperidol) Pulmonary Embolism Professional Injection SS SEE IMAGE Pulmonary Thrombosis Pyrexia Stupor Vena Cava Thrombosis Venous Thrombosis Limb Date:06/28/04ISR Number: 4389527-9Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20040405911 Age:73 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Drug Level Increased Health (Risperidone) PS ORAL SEE IMAGE Professional Sinemet Plus (Sinemet) SS ORAL SEE IMAGE Priadel (Lithium Carbonate) SS ORAL 3600 MG, ORAL 22-Feb-2006 08:20 AM Page: 2133 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Asasantin (Asasantin) C Lipitor (Atorvastatin) C Mirapexin (Pramipexole Dijydrochloride) C Nu-Seals (Acetylsalicylic Acid) C Flurazepam (Flurazepam) C Date:06/28/04ISR Number: 4389528-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040101337 Age:67 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Ischaemic Stroke Foreign Risperdal Hospitalization - Thermal Burn Health (Risperidone) PS ORAL SEE IMAGE Initial or Prolonged Professional Lofepramine Disability (Lofepramine) C Orphenadrine (Orphenadrine) C Priadel (Lithium Carbonate) C Paracetamol (Paracetamol) C Date:06/28/04ISR Number: 4389529-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040604066 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Movement Disorder Foreign Risperdal Health (Risperidone) PS 1 MG, IN 1 Professional DAY Topiramate (Topiramate) C Concerta Xl (Methylphenidate Hydrochloride) C Date:06/28/04ISR Number: 4389530-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040604078 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Risperdal Initial or Prolonged Drug Interaction Health (Risperdone) Tablets PS ORAL 2 MG, 2 IN 1 Stupor Professional DAY, ORAL Vascular Dementia Trimetazidine Servier (Trimetazidine) SS ORAL 40 MG, IN 1 DAY, ORAL Loxen (Nicardipine Hydrochloride) C Aprovel (Irbesartan) C Soprol (Bisoprolol Fumarate) C Acular (Ketorolac 22-Feb-2006 08:20 AM Page: 2134 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tromethamine) C Insulines Mixtard (Insulin) C Insulines Actrapid (Insulin) C Date:06/29/04ISR Number: 4388071-2Report Type:Direct Company Report #CTU 221750 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Risperidone PS ORAL 4MG QD ORAL Decreased Divalproex SS ORAL 2000MG QD Platelet Count Decreased ORAL White Blood Cell Count Date:06/29/04ISR Number: 4388093-1Report Type:Direct Company Report #CTU 221746 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Risperidone PS ORAL 4 MG BID ORAL Decreased White Blood Cell Count Decreased Date:06/30/04ISR Number: 4387858-XReport Type:Expedited (15-DaCompany Report #PHBS2004SE07831 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Tegretol Retard PS Novartis Sector: Initial or Prolonged Blood Alkaline Pharma ORAL Other Phosphatase Increased Efexor SS 75 mg, UNK Blood Potassium Decreased Risperidone SS .5 mg, UNK Blood Sodium Decreased Alvedon C Brain Oedema Movicol C Bruxism Propavan C 25 mg, UNK Cerebral Atrophy Stesolid C 5 mg, UNK Communication Disorder Sodium Chloride C 500 mg, UNK Convulsion Xanor C .25 mg, UNK Depressed Level Of Consciousness Diarrhoea Fall Head Injury Hypokalaemia Hyponatraemia Muscle Spasms Musculoskeletal Stiffness Date:06/30/04ISR Number: 4389468-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040303269 Age:13 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anorexia Initial or Prolonged Asthenia Colitis Diarrhoea Helicobacter Gastritis Hypersensitivity 22-Feb-2006 08:20 AM Page: 2135 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Painful Defaecation Rectal Haemorrhage Weight Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL SEE IMAGE Orap (Pimozide) Unspecified SS ORAL 2 MG, IN 1 DAY, ORAL Seretide (Seretide) C Ventoline (Salbutamol) C Date:06/30/04ISR Number: 4389996-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040401707 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Tachycardia Health Risperdal Initial or Prolonged Atrioventricular Block Professional (Risperidone) First Degree Unspecified PS ORAL SEE IMAGE Azotaemia Potassium Blood Creatinine (Potassium) C Increased Zoloft (Sertraline Blood Urea Increased Hydrochloride) C Bronchitis Acute Zocor (Simvastatin) C Bundle Branch Block Right Computerised Tomogram Abnormal Constipation Dehydration Delusion Disorientation Electrocardiogram Qt Prolonged Fall Haematocrit Decreased Haemoglobin Decreased Hypertension Hypokalaemia Loss Of Consciousness Myoglobin Blood Increased Pleural Effusion Pneumonia Pulmonary Oedema Supraventricular Extrasystoles Supraventricular Tachycardia Treatment Noncompliance Vomiting Date:06/30/04ISR Number: 4390000-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040606859 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS 22-Feb-2006 08:20 AM Page: 2136 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/04ISR Number: 4390004-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040606909 Age:69 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Tablets PS ORAL 3 MG, 2 IN 1 DAY, ORAL Date:06/30/04ISR Number: 4390063-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040502825 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Health Risperdal Consta Drug Exposure During Professional (Risperidone) Pregnancy Microspheres PS INTRAMUSCULAR 25 MG, Ectopic Pregnancy INTRAMUSCULAR Risperdal (Risperidone) Tablets SS ORAL 7 MG, IN 1 DAY , ORAL Lipitor (Atorvastatin) C Actos (Pioglitazone) C Insulin (Insulin) C Glipizide (Glipizide) C Prinivil (Lisinopril) C Date:06/30/04ISR Number: 4390140-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040604697 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Foreign Risperidal Initial or Prolonged Confusional State Health (Risperidone) Convulsion Professional Tabelts PS ORAL 2 MG, IN 1 Drug Interaction DAY, ORAL Loss Of Consciousness Seropram (Citalopram Malaise Hydrobromide) SS ORAL 20 MG, IN 1 Respiration Abnormal DAY; ORAL Sinus Tachycardia Tongue Injury Date:06/30/04ISR Number: 4390145-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040604423 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Adhesiveness Foreign Risperidal Abnormal Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:06/30/04ISR Number: 4390154-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040503084 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Other Breast Cancer Recurrent Foreign Hyperprolactinaemia Health 22-Feb-2006 08:20 AM Page: 2137 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperidal (Risperidone) Unspecified PS ORAL 2 MG, IN 1 DAY; ORAL Date:06/30/04ISR Number: 4390160-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040604502 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Foreign Risperdal Health (Risperidone) Professional Unspecified PS ORAL 3 MG, 2 IN 1 DAY; ORAL Date:06/30/04ISR Number: 4390573-XReport Type:Expedited (15-DaCompany Report #S04-USA-03513-01 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Lexapro Initial or Prolonged Convulsion Professional (Escitalopram) PS ORAL 10 MG QD PO Decreased Appetite Lexapro Depression (Escitalopram) SS ORAL 20 MG QD PO Drug Ineffective Lexapro Emotional Distress (Escitalopram) SS ORAL 10 MG QD PO Insomnia Risperdal Near Drowning (Risperidone) SS 3 MG QD Restlessness Schizoaffective Disorder Thinking Abnormal Date:06/30/04ISR Number: 4415365-4Report Type:Periodic Company Report #2003031728 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Consumer Zoloft (Sertraline) PS ORAL ORAL Dyskinesia Quetiapine Fumarate Feeling Abnormal (Quetiapine Tremor Fumarate) SS Risperidone (Risperidone) SS ORAL ORAL Date:06/30/04ISR Number: 4415672-5Report Type:Periodic Company Report #2004007445 Age:16 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Murder Health Zoloft (Sertraline) PS Professional Lorazepam (Lorazepam) SS Risperidone (Risperidone) SS 22-Feb-2006 08:20 AM Page: 2138 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/04ISR Number: 4390978-7Report Type:Direct Company Report #CTU 221999 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperidone PS Initial or Prolonged Phosphokinase Increased Myocardial Infarction Neuroleptic Malignant Syndrome Date:07/01/04ISR Number: 4393566-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040604066 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Movement Disorder Foreign Risperdal Health (Risperidone) Professional Unspecified PS 1 MG, 1 IN 1 DAY Topiramate (Topiramate) SS 50 MG, 2 IN 1 DAY Concerta Xl (Methylphenidate Hydrochloride) SS 54 MG Date:07/01/04ISR Number: 4393956-7Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20040604695 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Haemorrhagic Cerebral Foreign Risperdal Infarction Health (Risperidone) Professional Unspecified PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Warfarin (Warfarin) SS 27.5 MG, IN 1 WEEK Carbamazepine (Carbamazepine) C Ranitidine (Ranitidine) C Bumetanid (Bumetanide) C Hydroxizin (Hydroxyzine) C Oxazepam (Oxazepam) C Spironolaktion (Spironolactone) C Cetirizine 9cetirizine) C Date:07/02/04ISR Number: 4392692-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040606160 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Foreign Risperdal Health (Risperidone) PS ORAL 3 MG, IN 1 Professional DAY, ORAL Concerta (Methylphenidate Hydrochloride) 22-Feb-2006 08:20 AM Page: 2139 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sustained Release Tablets SS ORAL SEE IMAGE Date:07/02/04ISR Number: 4392948-1Report Type:Expedited (15-DaCompany Report #04P-062-0260467-00 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Akineton (Biperiden) Initial or Prolonged Disturbance In Attention Health (Biperiden) PS ORAL PER ORAL Somnolence Professional Mirtazapine SS ORAL PER ORAL Suicide Attempt Lorazepam SS ORAL PER ORAL Risperidone SS ORAL PER ORAL Zop 7.5 SS ORAL PER ORAL Isopromethazine Hydrochloride SS ORAL PER ORAL Dominal SS ORAL PER ORAL Flunitrazepam SS Date:07/02/04ISR Number: 4393102-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040305402 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Risperdal Initial or Prolonged Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:07/02/04ISR Number: 4393104-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040606158 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal Leukopenia Health (Risperidone) Neutropenia Professional Tablets PS ORAL 2 MG, IN 1 DAY, ORAL Date:07/02/04ISR Number: 4393115-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040607190 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Potassium Decreased Foreign Risperdal Hypoglycaemia Health (Risperidone) Leukopenia Professional Unspecified PS ORAL ORAL Thrombocytopenia Date:07/02/04ISR Number: 4393123-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040607188 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Risperdal Initial or Prolonged Health (Risperidone) Professional Unspecified PS ORAL 4 MG, 1 IN 1 DAY, ORAL Promethazine Hydrochloride C Triazolam C Lormetazepam C 22-Feb-2006 08:20 AM Page: 2140 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/02/04ISR Number: 4393132-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040201562 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fat Necrosis Foreign Risperdal Consta Initial or Prolonged Injection Site Mass Health (Risperidone) Subcutaneous Abscess Professional Microspheres PS INTRAMUSCULAR SEE IMAGE Zoloft (Tablets) Sertraline Hydrochloride C Date:07/02/04ISR Number: 4393134-1Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20040404284 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebral Infarction Foreign Risperdal Hospitalization - Loss Of Consciousness Health (Risperidone) Initial or Prolonged Professional Tablets PS ORAL 10 MG, IN 1 Disability DAY, ORAL Other Akineton Retard (Biperiden Hydrochloride) C Seroxat (Paroxetine Hydrochloride) C Stelazine (Trifluoperazine Hydrochloride) C Diazepam C Date:07/02/04ISR Number: 4393199-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040607194 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) Drug Interaction Professional Tablets PS ORAL 1 MG, IN 1 Leukopenia DAY, ORAL Neutropenia 'Norset' (Mirtazapine) SS ORAL 15 MG, IN 1 DAY, ORAL Tercian (Cyamemazine) C ORAL 2 DOSE (S), IN 1 DAY, ORAL Bactrim (Bactrim) C Date:07/02/04ISR Number: 4414486-XReport Type:Periodic Company Report #349347 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Other Klonopin (Clonazepam) PS Clozapine (Clozapine) SS ORAL 100 MG DAILY ORAL Protonix (Pantoprazole) SS Risperdal (Risperidone) SS 22-Feb-2006 08:20 AM Page: 2141 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lamotrigine (Lamotrigine) SS Cogentin (Benztropine Mesylate) C Date:07/06/04ISR Number: 4390806-XReport Type:Direct Company Report #CTU 222114 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Risperdal PS ORAL 0.5 MG PO BID Date:07/06/04ISR Number: 4390838-1Report Type:Direct Company Report #CTU 222192 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Risperdal Consta 25 Initial or Prolonged Syndrome Mg Janssen PS Janssen INTRAMUSCULAR 25 MG ONE Sepsis TIME INTRAMUSCULAR Date:07/06/04ISR Number: 4394815-6Report Type:Expedited (15-DaCompany Report #S04-FRA-02715-01 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Seropram (Citalopram Initial or Prolonged Dizziness Health Hydrobromide) PS ORAL 20 MG QD PO Drug Interaction Professional Risperdal Incontinence Other (Risperidone) SS ORAL 2 MG QD PO Loss Of Consciousness Malaise Sinus Tachycardia Snoring Tongue Biting Date:07/07/04ISR Number: 4391464-0Report Type:Expedited (15-DaCompany Report #ES-GLAXOSMITHKLINE-B0337417A Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Seroxat PS Glaxosmithkline ORAL 40MG per day 18 DAY Initial or Prolonged Fatigue Depakine SS ORAL 1G per day 18 DAY Sleep Apnoea Syndrome Trileptal SS ORAL 600MG per day 18 DAY Somnolence Risperdal SS ORAL 3ML per day 18 DAY Seroquel SS ORAL 400MG per day 18 DAY Deprax SS ORAL 100MCG per day 18 DAY Date:07/07/04ISR Number: 4395373-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040606157 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Inappropriate Foreign Risperdal Antidiuretic Hormone Health (Risperidone) PS ORAL ORAL Secretion Professional Rhabdomyolysis 22-Feb-2006 08:20 AM Page: 2142 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/07/04ISR Number: 4395374-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040404032 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Foreign Risperdal Unconjugated Increased Health (Risperidone) PS ORAL 2 MG, 2 IN 1 Coagulation Factor V Professional DAY, ORAL Level Decreased Tercian Coagulation Factor Viii (Cyamemazine) C Level Decreased Coagulation Factor X Level Decreased Prothrombin Level Decreased Prothrombin Time Shortened Date:07/07/04ISR Number: 4395375-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040605902 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Failure Foreign Risperdal Initial or Prolonged Health (Risperidone) PS ORAL 3 MG, 1 IN 1 Professional DAY, ORAL Date:07/07/04ISR Number: 4395823-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040602860 Age:1 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Cleft Lip And Palate Foreign Risperdal Drug Exposure During Health (Risperidone) PS TRANSPLACENTAL 3 MG, IN 1 Pregnancy Professional DAY, Company INTRA-UTERNIN Representative E Largactil (Chlorpromazine Hydrochloride) C Date:07/07/04ISR Number: 4395829-2Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040607186 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Foreign Risperdal Consta Initial or Prolonged Drug Toxicity Study (Risperidone) Homicidal Ideation Health Microspheres PS INTRAMUSCULAR SEE IMAGE Suicidal Ideation Professional Alcohol (Ethanol) SS Other Drugs Nos (All Other Non-Therapeutic Products) SS Valium (Diazepam) C Date:07/07/04ISR Number: 4395832-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040602727 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Other Anxiety Foreign Grand Mal Convulsion Health 22-Feb-2006 08:20 AM Page: 2143 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Company Representative Product Role Manufacturer Route Dose Duration Risperdal Consta (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 14 DAY, INTRA-MUSCULA R Risperdal (Risperidone) Unspecified SS ORAL 4 MG, IN 1 DAY ORAL Tercian (Cyamemazine) SS INTRAMUSCULAR 50 MG, IN 1 DAY, INTRA-MUSCULA R Date:07/07/04ISR Number: 4395835-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040606404 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Foreign Risperdal Consta Asthenia Health (Risperidone) Blood Prolactin Increased Professional Microspheres PS INTRAMUSCULAR 37.5 MG, Body Temperature INTRA-MUSCULA Increased R Drug Interaction Clozapine Endocrine Disorder (Clozapine) SS 225-450MG/DAY Hypotension Iron Sulfate Lethargy (Ferrous Sulfate) C Neutrophil Count Increased Oral Intake Reduced Pharyngolaryngeal Pain Sedation Weight Decreased White Blood Cell Count Increased Date:07/07/04ISR Number: 4395838-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040606653 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Foreign Risperdal Consta Initial or Prolonged Galactorrhoea Health (Risperidone) PS INTRAMUSCULAR INTRA-MUSCULA Professional R Date:07/07/04ISR Number: 4396047-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040607193 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Foreign Risperdal Initial or Prolonged Oestrogen Receptor Assay Health (Riseperidone) PS ORAL ORAL Other Positive Professional 22-Feb-2006 08:20 AM Page: 2144 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/04ISR Number: 4392683-XReport Type:Expedited (15-DaCompany Report #PHBS2004NO08833 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Leponex PS Novartis Sector: Pharma UNKNOWN Haldol SS Janssen UNKNOWN Chlorpromazine SS UNKNOWN Melleril SS UNKNOWN Nozinan SS UNKNOWN Risperdal SS UNKNOWN Serdolect SS UNKNOWN Sobril SS UNKNOWN Zyprexa SS UNKNOWN Date:07/08/04ISR Number: 4396837-8Report Type:Expedited (15-DaCompany Report #2004SE03657 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sleep Apnoea Syndrome Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Somnolence Health PO Professional Depakine SS ORAL 1 GR DAILY PO Other Trileptal SS ORAL 600 MG DAILY PO Risperdal SS ORAL 3 MG DAILY PO Deprax SS ORAL 100 UG DAILY PO Seroxat SS ORAL 40 MG DAILY PO Date:07/08/04ISR Number: 4397177-3Report Type:Expedited (15-DaCompany Report #EMADSS2002001190 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Weight Increased Foreign Risperdal Initial or Prolonged Consumer (Risperidone) Tablets PS ORAL SEE IMAGE Halodol (Haloperidol) Unspecified SS ORAL 15 MG ORAL Ergenyl (Valproate Sodium) Unspecified C Date:07/09/04ISR Number: 4393669-1Report Type:Direct Company Report #CTU 222496 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Risperdal Consta Injection Long Lasting PS Janssen Pharmaceutica Inc Date:07/09/04ISR Number: 4395618-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040603002 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Death Cardiac Disorder Consumer Lung Disorder Health 22-Feb-2006 08:20 AM Page: 2145 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal (Risperidone) PS Date:07/09/04ISR Number: 4395619-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040304628 Age:96 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL 0.5 MG, ORAL Date:07/09/04ISR Number: 4395621-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040600333 Age:46 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Consumer Risperdal Health (Risperidone) PS ORAL SEE IMAGE Professional Alprazolam (Alprazolam) C Neurontin (Neurontin) C Seroquel (Quetiapine Fumarate) C Date:07/09/04ISR Number: 4395650-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040701323 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:07/09/04ISR Number: 4395652-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040700242 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL 2 MG, 1 IN 1 Professional DAY, ORAL Date:07/09/04ISR Number: 4396474-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040104990 Age:16 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Foreign Risperidone Initial or Prolonged Gastric Disorder Health (Risperidone) Gastric Mucosal Professional Unspecified PS ORAL 2 MG, IN 1 Hypertrophy DAY, ORAL Gastrooesophageal Reflux Haloperidol C Disease Chlorpromazine Muscle Hypertrophy Hydrochloride C Oesophageal Disorder Biperiden Oesophageal Stenosis Hydrochloride C Vomiting Mosapride Citrate C 22-Feb-2006 08:20 AM Page: 2146 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/04ISR Number: 4396489-7Report Type:Expedited (15-DaCompany Report #IL-JNJFOC-20040700666 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemolysis Foreign Risperdal Iron Deficiency Health (Risperidone) PS 2 MG, 1 IN 1 Lupus-Like Syndrome Professional DAY Company Representative Date:07/09/04ISR Number: 4396494-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040700484 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Stem Haemorrhage Foreign Risperdal Health (Risperidone) PS ORAL 0.5 MG, 1 IN Professional 1 DAY, ORAL Date:07/09/04ISR Number: 4396499-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040701116 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Foreign Risperdal Health (Risperidone) PS ORAL 6 MG, 1 IN 1 Professional DAY, ORAL Sennoside (All Other Therapeutic Products) C Flunitrazepam (Flunitrazepam) C Sodium Valproate (Valproate Sodium) C Date:07/09/04ISR Number: 4396500-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040701114 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Risperdal Phosphokinase Increased Health (Risperidone) PS ORAL 6 MG, 1 IN 1 Excitability Professional DAY, ORAL Haemoglobin Decreased Flunitrazepam Irritability (Flunitrazepam) C Unevaluable Event Teprenone (Teprenone) C Lorazepam (Lorazepam) C Lansoprazole (Lansoprazole) C Lithium Carbonate (Lithium Carbonate) C Levomepromazine Maleate (Levomepromazine Maleate) C Biperiden Hydrochloride (Biperiden Hydrochloride) C Fk (Fk) C 22-Feb-2006 08:20 AM Page: 2147 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/04ISR Number: 4396502-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040607404 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Brachial Plexus Lesion Foreign Risperdal Drug Interaction Health (Risperidone) Nerve Root Lesion Professional Tablets PS ORAL 2 MG, 2 IN 1 Peripheral Motor DAY, ORAL Neuropathy Bactrim (Bactrim) Peripheral Sensory Unknown SS ORAL 400 MG, 1 IN Neuropathy 1 DAY, ORAL Mepronizine (Mepronizine) Capsules SS ORAL 2 DOSE(S), 1 IN 1 DAY, ORAL Cordarone (Amiodarone Hydrochloride) Unknown SS ORAL 200 MG, 1 IN 1 DAY, ORAL Thalidomide (Thalidomide) Unknown SS ORAL 200 MG, 1 IN 1 DAY, ORAL Triatec (Ramipril) C Sporanox (Itraconazole) C Flecaine (Flecainide Acetate) C Prozac (Fluoxetine Hydrochloride) C Skenan (Morphine Sulfate) C Date:07/09/04ISR Number: 4396506-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040607219 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Risperdal Drug Ineffective Health (Risperidone) PS ORAL 8 MG, IN 1 Professional DAY, ORAL Date:07/09/04ISR Number: 4396507-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040607209 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Foreign Risperdal Confusional State Health (Risperidone) PS ORAL 6 MG, 1 IN 1 Delusional Disorder, Professional DAY, ORAL Unspecified Type Neurocil Disorientation (Levomepromazine Drug Interaction Maleate) SS ORAL 75 MG, IN 1 Parkinsonism DAY, ORAL 22-Feb-2006 08:20 AM Page: 2148 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/09/04ISR Number: 4396509-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040607190 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Potassium Decreased Foreign Risperdal Hypoglycaemia Health (Risperidone) PS ORAL ORAL Leukopenia Professional Quetiapine Fumarate Thrombocytopenia (Quetiapine Fumarate) C Zolpidem Tartrate (Zolpidem Tartrate) C Mianserin Hydrochloride (Mianserin Hydrochloride) C Date:07/09/04ISR Number: 4396522-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040401553 Age:61 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Foreign Risperdal Consta Agitation Health (Risperidone) Aphasia Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Asthenia WEEK, Blood Albumin Increased INTRAMUSCULAR Blood Creatine Risperidone Phosphokinase Increased (Risperidone) C Blood Pressure Diastolic Increased Drooling Dysphagia Emotional Distress Feeling Abnormal Hostility Hypotonia Neuroleptic Malignant Syndrome Treatment Noncompliance Date:07/09/04ISR Number: 4396523-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040701117 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Risperdal Erythropenia Health (Risperidone) PS ORAL 6 MG, IN 1 Inadequate Diet Professional DAY, ORAL Lorazepam (Lorazepam) C Chlorpromazine Tannate (Chlorpromazine) C Flunitrazepam (Flunitrazepam) C Aldioxa (Aldioxa) C Stomachics And Digestives (Stomachic Mixture /Tha/) C Sennoside (All Other 22-Feb-2006 08:20 AM Page: 2149 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Therapeutic Products) C Sodium Picosulfate (Sodium Picosulfate) C Date:07/12/04ISR Number: 4394341-4Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12629689 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sleep Apnoea Syndrome Health Deprax PS Apothecon ORAL Initial or Prolonged Somnolence Professional Depakine SS ORAL Trileptal SS ORAL Risperdal SS ORAL Seroquel SS ORAL Seroxat SS ORAL Date:07/12/04ISR Number: 4398588-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040603421 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Interaction Foreign Risperdal Erectile Dysfunction Health (Risperidone) Professional Tablets PS ORAL 8 MG, IN 1 Company DAY, ORAL; Representative SEE IMAGE Risperdal Consta (Risperidone) Microspheres SS INTRAMUSCULAR 50 MG, 1 IN 14 DAY, INTRA-MUSCULA R Date:07/12/04ISR Number: 4398591-2Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20040203230 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Foreign Risperdal Consta Study (Risperidone) PS INTRAMUSCULAR 25 MG, 1 IN Health 15 DAY, Professional INTRAMUSCULAR Tertensif (Tablets) Indapamide C Dianben (Metformin Hydrochloride) C Cusimolol (Timolol Maleate) Drops C Pilocarpine Drops C Date:07/12/04ISR Number: 4398618-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040606650 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal Leukopenia Health (Risperidone) PS ORAL 5 MG, 1 IN 1 Lymphocyte Percentage Professional DAY, ORAL Increased Nitrazepam Thrombocytopenia (Nitrazepam) C 22-Feb-2006 08:20 AM Page: 2150 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diazepam (Diazepam) C Sulpride (Sulpiride) C Perospirone (All Other Therapeutic Products) C Olanzapine (Olanzapine) C Date:07/12/04ISR Number: 4398621-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031003790 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Macrocytic Foreign Risperidone Blood Alkaline Health (Risperidone) PS ORAL ORAL Phosphatase Decreased Professional Diazepam (Diazepam) SS ORAL ORAL Blood Folate Decreased Nitrazepam Haemolytic Anaemia (Nitrazepam) SS ORAL ORAL Haptoglobin Decreased Other Medications Myelodysplastic Syndrome (Unknown) All Other Reticulocyte Count Therapeutic Products C Increased Date:07/12/04ISR Number: 4398845-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040300045 Age:64 YR Gender:Male I/FU:F Outcome PT Death Brain Oedema Catatonia Cogwheel Rigidity Coma Dementia Drooling Electrocardiogram T Wave Abnormal Electroencephalogram Abnormal Gastric Outlet Obstruction Gastrooesophageal Reflux Disease Hallucination Hypoxia Immobile Incontinence Ischaemia Malnutrition Muscle Rigidity Musculoskeletal Stiffness Nervous System Disorder Neuroleptic Malignant Syndrome Occult Blood Positive Parkinson'S Disease Pituitary Tumour Benign Pneumonia Aspiration Posture Abnormal Pseudomonas Infection Psychomotor Retardation Pyrexia 22-Feb-2006 08:20 AM Page: 2151 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rathke'S Cleft Cyst Schizophrenia Sinus Arrhythmia Report Source Product Role Manufacturer Route Dose Duration Sluggishness Consumer Risperdal Staring (Risperidone) PS ORAL 2 MG, 2 IN 1 Therapy Non-Responder DAY, ORAL; Treatment Noncompliance SEE IMAGE Tremor Haldol Decanoate Urinary Tract Infection (Haloperidol Decanoate) Injection SS INTRAMUSCULAR 75 MG, 1 IN 4 WEEK, INTRA-MUSCULA R Haldol (Haloperidol) Unspecified SS ORAL 5 MG, 2 IN 1 DAY, ORAL; SEE IMAGE Benztropine (Benzatropine Mesilate) C Date:07/12/04ISR Number: 4398850-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040701308 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatinine Consumer Risperdal Increased (Risperidone) PS ORAL 2 MG, IN 1 Blood Urea Increased DAY, ORAL; SEE IMAGE Digoxin C Lasix (Furosemide) C Tenormin (Atenolol) C Zoloft (Sertraline Hydrochloride) C Date:07/12/04ISR Number: 4398852-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040601513 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pelvic Fracture Consumer Risperdal Health (Risperidone) PS ORAL 0.25 MG, ORAL Professional Other Date:07/12/04ISR Number: 4398855-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040502087 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS Professional 22-Feb-2006 08:20 AM Page: 2152 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/04ISR Number: 4398856-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040501597 Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Risperdal Congestive Health (Risperidone) PS ORAL 0.5 MG, 2 IN Condition Aggravated Professional 1 DAY, ORAL Date:07/12/04ISR Number: 4398857-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040406560 Age:83 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS ORAL ORAL Date:07/13/04ISR Number: 4396621-5Report Type:Direct Company Report #CTU 222646 Age:3 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Risperdal 1 Mg PS ORAL 1 MG PO QD Initial or Prolonged Convulsion Zyrtec 5mg/5mls SS ORAL 7.5 MG PO QHS Coordination Abnormal Depressed Level Of Consciousness Drooling Eye Movement Disorder Fall Fluid Intake Reduced Inappropriate Affect Mental Status Changes Somnolence Speech Disorder Staring Tremor Date:07/13/04ISR Number: 4396865-2Report Type:Direct Company Report #CTU 222709 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abortion Neurontin PS GENERIC Hospitalization - Adoption NEURONTIN Initial or Prolonged Congenital Anomaly PILLS Disability Drug Exposure During Lithium SS LITHIUM PILLS Required Pregnancy Haldol SS HALDOL DEC Intervention to Injury SHOT Prevent Permanent Pregnancy Respridol SS RESPRIDAL Impairment/Damage Road Traffic Accident PILLS Date:07/13/04ISR Number: 4397653-3Report Type:Expedited (15-DaCompany Report #139345USA Age:12 YR Gender:Female I/FU:I Outcome PT Hospitalization - Abdominal Pain Initial or Prolonged Anorexia Asthenia Biopsy Site Unspecified Abnormal Colonoscopy Abnormal 22-Feb-2006 08:20 AM Page: 2153 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Enterocolitis Haemorrhagic Report Source Product Role Manufacturer Route Dose Duration Erythema Foreign Pimozide PS ORAL 2 MILLIGRAM, Helicobacter Gastritis Health ORAL 57 WK Rectal Haemorrhage Professional Risperidone SS ORAL 4 MILLIGRAM/3 Rectal Tenesmus MILLIGRAM/2 Weight Increased MILLIGRAM ORAL 4 MON Seretide C Salbutamol C Date:07/13/04ISR Number: 4398367-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040607719 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Risperdal Initial or Prolonged Hallucination Health (Risperidone) Hypertonia Professional Tablets PS ORAL 0.5 MG, 2 IN Sepsis 1 DAY, ORAL Urinary Tract Infection Reminyl (Galatamine) Bacterial Tablets SS ORAL 16 MG, 1 IN 1 DAY, ORAL Lasilix (Furosemide) C Aldactone (Spironolactone) C Kardegic (Acetylsalicylate Lysine) C Tahor (Atorvastatin Calcium) C Vastarel (Trimetazidine Hydrochloride) C Seropram (Citalopram Hydrobromide) C Equanil (Meprobamate) Tablets C Mopral (Omeprazole) C Date:07/14/04ISR Number: 4400052-9Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20040604519 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperdal Gynaecomastia Health (Risperidone) PS ORAL 0.5 MG, ORAL Professional Concerta (Methylphenidate Hydrochloride) Unspecified SS ORAL 54 MG, ORAL Date:07/14/04ISR Number: 4400054-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040607949 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Other Leukopenia Foreign Health 22-Feb-2006 08:20 AM Page: 2154 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Role Manufacturer Route Dose Duration Risperdal Consta (Risperidone) Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Trevilor (Venlafaxine Hydrochloride) C Orfiril (Valproate Sodium) C Lorazepam (Lorazepam) C Ferro Sanol (Ferro-Sanol B) C Taxilan (Perazine) C Date:07/14/04ISR Number: 4400057-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040506140 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperprolactinaemia Foreign Risperdal Initial or Prolonged Metrorrhagia Health (Risperidone) PS ORAL SEE IMAGE Ovarian Neoplasm Professional Biperiden Hydrochloride (Biperiden Hydrochloride) C Bromocriptine Mesylate (Bromocriptine) C Brotizolam (Brotizolam) C Ethyl Loflazepate (Ethyl Loflazepate) C Diazepam (Diazepam) C Chlorpromazine Hydrochloride (Chlorpromazine Hydrochloride) C Date:07/14/04ISR Number: 4400097-9Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040607186 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Foreign Risperdal Consta Initial or Prolonged Drug Toxicity Study (Risperidone) Homicidal Ideation Health Microspheres PS INTRAMUSCULAR SEE IMAGE Suicidal Ideation Professional Alcohol (Ethanol) SS Valium (Diazepam) C 22-Feb-2006 08:20 AM Page: 2155 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/04ISR Number: 4401806-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040701927 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL ORAL Professional Date:07/14/04ISR Number: 4401808-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040701923 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Risperdal Health (Risperidone) PS ORAL 3 MG, 1 IN 1 Professional DAY, ORAL Date:07/14/04ISR Number: 4401811-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040701365 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal Initial or Prolonged Dementia (Risperidone) PS ORAL 0.25 MG, 2 IN 1 DAY, ORAL Reminyl (Galantamine) Tablets C Date:07/14/04ISR Number: 4401837-5Report Type:Expedited (15-DaCompany Report #2004044348 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Cold Consumer Neurontin Headache (Gabapentin) PS Hyperhidrosis Quetiapine Fumarate Muscle Twitching (Quetiapine Musculoskeletal Stiffness Fumarate) SS Nerve Injury Risperidone Suicidal Ideation (Risperidone) SS Tardive Dyskinesia Oxcarbazepine Weight Decreased (Oxcarbazepine) C Zolpidem Tartrate (Zolpidem Tartrate) C Date:07/14/04ISR Number: 4402029-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040701445 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Health Risperdal Consta Initial or Prolonged Neuroleptic Malignant Professional (Risperidone) Other Syndrome Company Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Sepsis Representative WEEK, Tachycardia INTRA-MUSCULA R Depakote ( ) Valproate Semisodium C 22-Feb-2006 08:20 AM Page: 2156 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/04ISR Number: 4402033-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040701655 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) PS Company Representative Date:07/15/04ISR Number: 4404808-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040702552 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Literature Risperdal Initial or Prolonged Blood Creatine Health (Risperidone) Phosphokinase Increased Professional Unspecified PS 1.5 MG Blood Pressure Diastolic Alendronate Sodium C Decreased Simvastatin C Body Temperature Vitamin D Decreased (Ergocalciferol) C Dizziness Calcium C Feeling Cold Metabolic Acidosis Date:07/15/04ISR Number: 4404809-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040702401 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, IN 1 DAY, ORAL Date:07/16/04ISR Number: 4399881-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040607996 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Risperdal Initial or Prolonged Condition Aggravated Health (Risperidone) Photosensitivity Reaction Professional Solution PS SEE IMAGE Fluoride (Drops) Fluoride) C Paracetamol (Paracetamol) C Date:07/16/04ISR Number: 4399882-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040702328 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Constipation Foreign Risperdal Leukopenia Health (Risperidone) PS ORAL SEE IMAGE Thirst Professional Flunitrazepam Weight Increased (Flunitrazepam) C Trihexyphenidyl Hydrochloride (Trihexyphenidyl Hydrochloride) C Etizolam (Etizolam) C 22-Feb-2006 08:20 AM Page: 2157 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam (Lorazepam) C Olanzapine (Olanzapine) C Quazepam (Quazepam) C Date:07/16/04ISR Number: 4399886-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040607193 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Male Foreign Risperdal Initial or Prolonged Health (Risperidone) PS ORAL ORAL Other Professional Date:07/16/04ISR Number: 4399889-4Report Type:Expedited (15-DaCompany Report #GB-JNJF0C-20040604502 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Foreign Risperdal Health (Risperidone) PS ORAL 3 MG, 2 IN 1 Professional DAY, ORAL Stelazine (Trifluoperazine Hydrochloride) C Date:07/16/04ISR Number: 4400655-1Report Type:Direct Company Report #CTU 222950 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Risperidone PS 2 M QAM 1 MG Initial or Prolonged QPM Date:07/16/04ISR Number: 4405114-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040505807 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Health Risperdal Pregnancy Professional (Risperidone) PS ORAL 2.5 MG, 1 IN Uterine Contractions 1 DAY, ORAL Abnormal Zoloft (Setraline Uterine Contractions Hydrochloride) C During Pregnancy Date:07/16/04ISR Number: 4406638-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040602727 Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Foreign Risperdal Consta Grand Mal Convulsion Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN Company 14 DAY, Representative INTRA-MUSCULA R Risperdal (Risperidone) Unspecified SS ORAL 4 MG, IN 1 22-Feb-2006 08:20 AM Page: 2158 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY, ORAL Tercian (Cyamemazine) SS INTRAMUSCULAR 50 MG, IN 1 DAY, INTRA-MUSCULA R Date:07/19/04ISR Number: 4401857-0Report Type:Direct Company Report #USP 56719 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Risperdal M PS Janssen Pharmaceutica TABLET Risperdal SS Janssen TABLET Date:07/19/04ISR Number: 4402131-9Report Type:Direct Company Report #CTU 223049 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Risperidone 0.5 Mg Catatonia And 2 Mg Jannsen PS ORAL 0.5 MG PO AM Coma , W MG POHS Feeling Cold Sertraline 50 Mg SS ORAL 50 MG PO AM Joint Stiffness Musculoskeletal Stiffness Paranoia Psychotic Disorder Pulse Absent Selective Mutism Treatment Noncompliance Date:07/19/04ISR Number: 4403732-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040703685 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Date:07/19/04ISR Number: 4403909-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040700484 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Stem Haemorrhage Foreign Risperdal Initial or Prolonged Health (Risperidone) PS ORAL 0.5 MG, 1 IN Professional 1 DAY, ORAL Date:07/19/04ISR Number: 4403913-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040607188 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Risperdal Initial or Prolonged Health (Risperidone) PS ORAL 4 MG, 1 IN 1 Professional DAY, ORAL Promethazine Hydrochloride 22-Feb-2006 08:20 AM Page: 2159 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Promethazine Hydrocloride) C Triazaolam (Triazolam) C Lormetazepam (Lormetazepam) C Date:07/19/04ISR Number: 4403938-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040701514 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Foreign Risperdal Initial or Prolonged Anticholinergic Syndrome Health (Risperidone) PS ORAL 4 MG, IN 1 Other Hepatic Failure Professional DAY, ORAL Loss Of Consciousness Paroxetin Renal Failure Acute (Paroxetine) C Rhabdomyolysis Date:07/19/04ISR Number: 4403941-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040701270 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal Platelet Count Decreased Health (Risperidone) PS Professional Venlafaxine Xl (Venlafaxine) C Date:07/19/04ISR Number: 4403952-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040701513 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Foreign Risperdal Eye Swelling Health (Risperidone) PS ORAL 2 MG, ORAL Swelling Face Professional Date:07/19/04ISR Number: 4403957-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040502117 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angiopathy Foreign Risperdal Atherosclerosis Health (Risperidone) PS ORAL ORAL Erectile Dysfunction Professional Depakine 9valproate Glucose Tolerance Sodium) C Impaired Sintrom Gynaecomastia (Acetylsalicylic Insulin Resistance Acid) C Metabolic Syndrome Maxepa (Maxepa) C Urinary Incontinence Weight Increased Date:07/19/04ISR Number: 4403959-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040500591 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Risperdal Hospitalization - Syndrome Health (Risperidone) PS ORAL SEE IMAGE Initial or Prolonged Urinary Tract Infection Professional Chlorpromazine(Choro 22-Feb-2006 08:20 AM Page: 2160 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report promazine C Antidepressante (Antidepressants) C Date:07/19/04ISR Number: 4404135-9Report Type:Expedited (15-DaCompany Report #DSA_24622_2004 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Foreign Temesta PS Intentional Overdose Health Alcohol SS Multiple Drug Overdose Professional Risperdal SS Other Date:07/19/04ISR Number: 4404419-4Report Type:Expedited (15-DaCompany Report #2004044964 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Zoloft (Sertraline) PS Initial or Prolonged Increased Health Resperidone Aspartate Professional (Risperidone) SS Aminotransferase Company Increased Representative Gamma-Glutamyltransferase Increased Date:07/20/04ISR Number: 4404567-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040505714 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Acute Foreign Risperdal Consta Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Metoclopramide (Metoclopramide) C Thyroxine (Levothyroxine Sodium) C Date:07/21/04ISR Number: 4404138-4Report Type:Direct Company Report #CTU 223166 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anger Rispedol 25mg 2xs Required Speech Disorder Day PS Intervention to Strattern 25mg 1xs Prevent Permanent Day SS Impairment/Damage Date:07/21/04ISR Number: 4407143-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040500834 Age:36 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sickle Cell Anaemia With Health Risperdal M-Tabs Initial or Prolonged Crisis Professional (Risperidone) 22-Feb-2006 08:20 AM Page: 2161 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablets PS ORAL 3 MG, 2 IN 1 DAY, ORAL Zyprexa (Olanzapine) C Date:07/21/04ISR Number: 4407315-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040704058 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL ORAL Professional Date:07/21/04ISR Number: 4407379-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040703693 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.5 MG, ORAL Date:07/21/04ISR Number: 4407385-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040703092 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Health Risperdal Initial or Prolonged Bradycardia Professional (Risperidone) PS ORAL 3 MG, IN 1 Decreased Appetite DAY, ORAL Depression Escitalopram Disease Recurrence (Citalopram) SS SEE IMAGE Drug Ineffective Emotional Distress Insomnia Medication Error Restlessness Schizoaffective Disorder Treatment Noncompliance Date:07/21/04ISR Number: 4407386-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040402593 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS 1 MG, IN 1 Professional DAY Date:07/21/04ISR Number: 4407811-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040602726 Age: Gender:Male I/FU:F Outcome PT Hospitalization - Faecal Incontinence Initial or Prolonged Feeling Drunk Disability Hallucination Other Loss Of Control Of Legs Muscle Rigidity Retinal Scar Urinary Incontinence Verbal Abuse 22-Feb-2006 08:20 AM Page: 2162 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Visual Disturbance Weight Increased Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Consumer (Risperidone) Unspecified PS 1 MG, 2 IN 1 DAY Date:07/21/04ISR Number: 4407812-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040502791 Age:52 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperkalaemia Foreign Risperdal Consumer (Risperidone) Health Tablets PS ORAL 4 MG, 2 IN 1 Professional DAY, ORAL Sodium Valproate (Valproate Sodium) C Zolpidem (Zolpidem) C Date:07/21/04ISR Number: 4407813-0Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040501168 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Foreign Risperidone Initial or Prolonged Csf Pressure Increased Health (Risperidone) Other Headache Professional Unspecified PS ORAL SEE IMAGE Hypomania Lithium Carbonate Hypothyroidism (Lithium Carbonate) SS ORAL 1000 MG, IN 1 Intracranial Pressure DAY, ORAL Increased Antitriptyline Papilloedema (Amitriptyline) C Retinal Haemorrhage Metformin (Metformin) C Date:07/21/04ISR Number: 4407814-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040200004 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Risperdal Initial or Prolonged Condition Aggravated Health (Risperidone) Enterocolitis Professional Unspecified PS ORAL SEE IMAGE Extrapyramidal Disorder Dai-Kenchu-To (All Haemochromatosis Other Therapeutic Ileus Paralytic Products) C Iron Deficiency Anaemia Magnesium Oxide Parkinsonian Gait (Magnesium Oxide) C Schizophrenia Lorazepam (Lorazepam) C Pantethine (Pantethine) C Antidiarrheals, Intestinal Regulators (All Other Therapeutic Products) C Mosapride Citrate (Mosapride Citrate) C 22-Feb-2006 08:20 AM Page: 2163 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dimeticone (Dimeticone) C Distigmine Bromide (Distigmine Bromide) C Piperacillin Sodium (Piperacillin Sodium) C Alprazolam (Alprazolam) C Zopiclone (Zopiclone) C Sennoside (All Other Therapeutic Products) C Date:07/22/04ISR Number: 4404433-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB02356 Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Clozaril PS Novartis Sector: Agitation Professional Pharma ORAL 150mg nocte Body Temperature and 125mg Increased mane Confusional State Risperidone SS Dizziness Drug Withdrawal Syndrome Dysphagia Hyperhidrosis Hypotension Malaise Muscle Rigidity Pain Refusal Of Examination Restlessness Salivary Hypersecretion Tachycardia Throat Tightness Date:07/22/04ISR Number: 4405235-XReport Type:Direct Company Report #CTU 223339 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Tenex .1 Mg PS ORAL 1 QD ORAL Chest Pain Risperdal .5 Mg SS ORAL 1 BID ORAL Drug Ineffective Dyspnoea Heart Rate Increased Joint Injury Mood Swings Pain Salivary Hypersecretion Treatment Noncompliance 22-Feb-2006 08:20 AM Page: 2164 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/22/04ISR Number: 4408196-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040703245 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blast Cells Present Foreign Risperidone Health (Risperidone) Professional Unspecified PS ORAL ORAL Date:07/22/04ISR Number: 4408199-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040606157 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Inappropriate Foreign Risperdal Antidiuretic Hormone Health (Risperidone) Secretion Professional Unspecified PS ORAL ORAL Rhabdomyolysis Date:07/22/04ISR Number: 4408294-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040504842 Age:99 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL ORAL Professional Lasix (Furosemide) C Gluburide (Glibenclamide) C Ntg (Glyceryl Trinitrate) C Digoxin (Digoxin) C Potassium (Potassium) C Date:07/22/04ISR Number: 4409360-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040704150 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Consta Professional (Risperidone) Microspheres PS INTRAMUSCULAR 50 MG , 1 IN 2 WEEK, INTRA-MUSCULA R Haldol (Haloperidol) Injection SS INTRAVENOUS 150 MG, IN 1 DAY, INTRAVENOUS Date:07/22/04ISR Number: 4409361-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040704130 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal M-Tabs Professional (Risperidone) Tablets PS ORAL 1 MG, ORAL 22-Feb-2006 08:20 AM Page: 2165 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/04ISR Number: 4407079-1Report Type:Direct Company Report #CTU 223448 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Device Failure Risperdal Consta 26 Pharmaceutical Product Mg (5 Kits) Janssen PS Janssen INTRAMUSCULAR 25 MG EVERY 2 Complaint WEE INTRAMUSCULAR Risperdal Consta 37.5 Mg (1 Kit) Janssen SS Janssen INTRAMUSCULAR 37.5 MG EVERY 2 WE INTRAMUSCULAR Date:07/23/04ISR Number: 4407213-3Report Type:Direct Company Report #CTU 223460 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Risperidone 0.5 Mg Hospitalization - Syndrome And 1 Mg Janssen PS Janssen ORAL 2.5 MG EVERY Initial or Prolonged AM ORAL Risperidone 0.5 Mg And 1 Mg Janssen SS Janssen ORAL 3 MG EVERY PM ORAL Date:07/23/04ISR Number: 4408693-XReport Type:Expedited (15-DaCompany Report #2004042258 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Akathisia Foreign Zeldox (Capsules) Completed Suicide Company (Ziprasidone) PS ORAL 160 MG (2 IN Drug Ineffective Representative 1 D), ORAL Food Craving Risperidone Weight Increased (Risperidone) SS Aripiprazole(Aripipr azole) SS Isopromethazine Hydrochloride (Isopromethazine Hydrochloride) C Reboxetine (Reboxetine) C Date:07/23/04ISR Number: 4409524-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040704586 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Risperdal Anaemia Health (Risperidone) Blood Amylase Increased Professional Unspecified PS ORAL 3 MG, 1 IN 1 Blood Triglycerides DAY, ORAL Increased SEE IMAGE Drug Ineffective Biperiden Hyperlipidaemia Hydrochloride C Diazepam C Propranolol Hydrochloride C Tandospirone Citrate C 22-Feb-2006 08:20 AM Page: 2166 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/23/04ISR Number: 4409535-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040704895 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperdone) PS ORAL ORAL Professional Date:07/26/04ISR Number: 4407749-5Report Type:Expedited (15-DaCompany Report #PHBS2004ES09714 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Trileptal PS Novartis Sector: Hospitalization - Pyrexia Pharma ORAL 600 mg/d Initial or Prolonged Serology Negative Risperdal SS ORAL 2 mg/d Modecate "Sanofi Winthrop" SS INTRAMUSCULAR 12 mg/d Akineton SS INTRAMUSCULAR 2.5 mg/d Date:07/26/04ISR Number: 4408231-1Report Type:Direct Company Report #CTU 223527 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Confusional State Risperdal Consta Hospitalization - Dysarthria Im PS Q 2 WEEKS Initial or Prolonged Fall Required Pco2 Increased Intervention to Respiratory Disorder Prevent Permanent Sleep Disorder Impairment/Damage Date:07/26/04ISR Number: 4409913-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040702773 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Risperdal White Blood Cell Count Health (Risperidone) PS ORAL 3 MG, ORAL Decreased Professional Date:07/26/04ISR Number: 4409936-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040701514 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anticholinergic Syndrome Foreign Risperdal Hospitalization - Hepatic Failure Health (Risperidone) PS ORAL 4 MG, IN 1 Initial or Prolonged Loss Of Consciousness Professional DAY, ORAL Other Renal Failure Acute Paroxetin Rhabdomyolysis (Paroxetine) C Tavor (Lorazepam) C Date:07/26/04ISR Number: 4410493-1Report Type:Expedited (15-DaCompany Report #S04-FRA-03044-01 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Confusional State Foreign Initial or Prolonged Fall Health Hyponatraemia Professional 22-Feb-2006 08:20 AM Page: 2167 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Seropram (Citalopram Hydrobromide) PS ORAL SEE IMAGE Risperdal (Risperidone) SS ORAL 2 MG QD PO Date:07/26/04ISR Number: 4410499-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040700484 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Stem Haemorrhage Foreign Risperdal Initial or Prolonged Difficulty In Walking Health (Risperidone) PS ORAL 0.5 MG, 1 IN Disability Gait Disturbance Professional 1 DAY ORAL Hemiplegia Lorazepam Hypoaesthesia (Lorazepam) C Pain In Extremity Date:07/26/04ISR Number: 4410518-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040607190 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Potassium Decreased Foreign Risperdal Hypoglycaemia Health (Risperidone) PS ORAL ORAL Leukopenia Professional Quetiapine Fumarate Thrombocytopenia (Quetiapine Fumarate) C Zolpidem Tartrate (Zolpidem Tartrate) C Mianserin Hydrochloride (Mianserin Hydrochloride) C Date:07/26/04ISR Number: 4410592-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040705349 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidol) Unspecified PS ORAL ORAL Date:07/26/04ISR Number: 4410594-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040400330 Age:84 YR Gender:Female I/FU:I Outcome PT Death Arrhythmia Blood Glucose Increased Difficulty In Walking Dry Mouth Dysphagia Fatigue Gait Disturbance Hypoacusis Lymphocyte Count Decreased 22-Feb-2006 08:20 AM Page: 2168 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Memory Impairment Musculoskeletal Stiffness Oedema Peripheral Report Source Product Role Manufacturer Route Dose Duration Posture Abnormal Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 1 MG, 2 IN 1 DAY, ORAL Seroquel (Quetiapine Fumarate) C Coumadin (Warfarin Sodium) C Heart Medication (Cardiac Therapy) C Lorazepam (Lorazepam) C Furosemide (Furosemide) C Aricept (Donepezil Hydrochloride) C Amiben (Zolpidem Tartrate) C Diltiazem Cd (Diltiazem Hydrochloride) C Date:07/26/04ISR Number: 4410596-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040401982 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Health Risperdal Professional (Risperidone) Unspecified PS ORAL ORAL Date:07/27/04ISR Number: 4409758-9Report Type:Direct Company Report #CTU 223651 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aphasia Risperidone 0.5mg Hospitalization - Cerebrovascular Accident Jannsen PS Jannsen ORAL 0.5MG BID Initial or Prolonged Mental Status Changes ORAL Disability Pneumonia Aspiration Tenofavir C Epivir C Kaletra C Flexeril C Ranitidine C Albuterol Inhaler C Aerobid C Beconase C Date:07/27/04ISR Number: 4411574-9Report Type:Direct Company Report #CTU 223691 Age:23 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged Required Intervention to 22-Feb-2006 08:20 AM Page: 2169 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Neuroleptic Malignant Risperidal Consta - Syndrome Janssen PS Janssen INTRAMUSCULAR 25 MG IM Q 2 W Date:07/27/04ISR Number: 4411652-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040703245 Age: Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration No Adverse Drug Effect Foreign Risperidone Health (Risperidone) PS Professional Date:07/27/04ISR Number: 4412294-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040706125 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) Professional Unspecified PS Date:07/28/04ISR Number: 4410888-6Report Type:Direct Company Report #CTU 223774 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatitis Divalproex PS ORAL ORAL Initial or Prolonged Risperidone SS ORAL ORAL Required Clonazepam C Intervention to Al Hydroxide/Mg Prevent Permanent Hydrox/Simethicone C Impairment/Damage Multivitamin C Atenolol C Milk Of Magnesia C Hydroxyzine Hcl C Acetaminophen C Date:07/28/04ISR Number: 4413372-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040706002 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL ORAL Professional Date:07/28/04ISR Number: 4413997-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040607219 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Foreign Risperdal Drug Ineffective Health (Risperidone) PS ORAL 7 MG, IN 1 Psychotic Disorder Professional DAY, ORAL 22-Feb-2006 08:20 AM Page: 2170 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4414642-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040706519 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysstasia Foreign Risperdal Consta Initial or Prolonged Fatigue Health (Risperidone) Feeling Drunk Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN Hypotonia 14 DAY, Mobility Decreased INTRA-MUSCULA R Risperdal (Risperidone) Tablets SS ORAL 8 MG, IN 1 DAY, ORAL Tercian (Cyamemazine) C Imovane (Zopiclone) C Artane (Trihexyphenidyl Hydrochloride) C Thiamine (Thiamine) C Vitamin B1 (Thiamine Hydrochloride) C Vitamin B6 (Pyridoxine Hydrochloride) C Date:07/29/04ISR Number: 4414644-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040706065 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antinuclear Antibody Foreign Risperdal Positive Health (Risperidone) Cardiolipin Antibody Professional Solution PS ORAL SEE IMAGE Positive Risperdal Consta Neutropenia (Risperidone) Thrombocytopenia Microspheres SS INTRAMUSCULAR 37.5 MG, 1 IN 14 DAY, INTRA-MUSCULA R Date:07/29/04ISR Number: 4414645-6Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20040404284 Age:48 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebral Infarction Foreign Risperdal Hospitalization - Cerebrovascular Accident Health (Risperidone) Initial or Prolonged Loss Of Consciousness Professional Tablets PS ORAL 10 MG, IN 1 Disability Pharmaceutical Product DAY, ORAL Other Complaint Akineton Retard (Biperiden Hydrochloride) C Seroxat (Paroxetine Hydrochloride) C Stelazine (Trifluoperazine Hydrochloride) C Diazepam (Diazepam) C 22-Feb-2006 08:20 AM Page: 2171 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4415498-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040704150 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Therapy Non-Responder Health Risperdal Consta Professional (Risperdone) Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Haldol (Haloperidol) Injection SS INTRAVENOUS 150 MG, IN 1 DAY, INTRAVENOUS Date:07/29/04ISR Number: 4443693-5Report Type:Periodic Company Report #US-JNJFOC-20040202311 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Risperdal Convulsion (Risperidone) Dysarthria Tablets PS ORAL SEE IMAGE Date:07/29/04ISR Number: 4443702-3Report Type:Periodic Company Report #US-JNJFOC-20040202341 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Consta Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Representative WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Unspecified SS UP TO 10.0 MG PER DAY Date:07/29/04ISR Number: 4443707-2Report Type:Periodic Company Report #US-JNJFOC-20040202280 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Risperdal Syndrome Professional (Risperidone) Company Unspecified PS Representative Date:07/29/04ISR Number: 4443710-2Report Type:Periodic Company Report #US-JNJFOC-20040202060 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Initial or Prolonged Syndrome Professional (Risperidone) Pneumonia Unspecified PS ORAL ORAL Seroquel (Quetiapine Fumarate) SS 500MG @ HS ; 100MG PRN FOR AGITATION 22-Feb-2006 08:20 AM Page: 2172 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium (Lithium) C Inderal (Propranolol Hydrochloride) C Date:07/29/04ISR Number: 4443713-8Report Type:Periodic Company Report #US-JNJFOC-20040200880 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Risperdal Syndrome Professional (Risperidone) Tablets PS ORAL 2 MG, 2 IN 1 DAY, ORAL; 1 MG, 2 IN 1 DAY, ORAL Geodon (Ziprasidone Hydrochloride) SS 20 MG Seroquel (Quetiapine Fumarate) SS 100 MG Date:07/29/04ISR Number: 4443720-5Report Type:Periodic Company Report #US-JNJFOC-20040201381 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Risperdal Initial or Prolonged Professional (Risperidone) Company Tablets PS ORAL ORAL Representative Date:07/29/04ISR Number: 4443724-2Report Type:Periodic Company Report #US-JNJFOC-20040200848 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Risperdal Parkinsonism (Risperidone) Solution PS ORAL 0.35 ML, 1 IN 1 DAY, ORAL Depakote (Valproate Semisodium) C Date:07/29/04ISR Number: 4443733-3Report Type:Periodic Company Report #US-JNJFOC-20040200222 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, 1 IN 1 DAY, ORAL Metformin (Metformin) C Date:07/29/04ISR Number: 4443736-9Report Type:Periodic Company Report #US-JNJFOC-20040105146 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Health Risperdal Initial or Prolonged Professional (Risperidone) 22-Feb-2006 08:20 AM Page: 2173 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Haldol (Haloperidol) Unspecified C Date:07/29/04ISR Number: 4443741-2Report Type:Periodic Company Report #US-JNJFOC-20040200144 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Risperdal Choking (Risperidone) Insomnia Tablets PS ORAL 2 MG, 2 IN 1 Loss Of Consciousness DAY, ORAL; 1 Tremor MG, 2 IN 1 DAY, ORAL Date:07/29/04ISR Number: 4443745-XReport Type:Periodic Company Report #US-JNJFOC-20030703161 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Risperdal Initial or Prolonged Dyskinesia Professional (Risperidone) Weight Decreased Solution PS ORAL SEE IMAGE Zoloft (Sertraline Hydrochloride) SS ORAL 60 MG, 1 IN 1 DAY, ORAL Date:07/29/04ISR Number: 4443748-5Report Type:Periodic Company Report #US-JNJFOC-20030704268 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Risperdal Attack (Risperidone) Unspecified PS Date:07/29/04ISR Number: 4443752-7Report Type:Periodic Company Report #US-JNJFOC-20030701209 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activities Of Daily Health Risperdal Living Impaired Professional (Risperidone) Cerebrovascular Accident Tablets PS ORAL ORAL Aricept (Donepezil Hydrochloride) C Multivitamin (Multivitamins) C Calcium (Calcium) C Evista (Raloxifene Hydrochloride) C Date:07/29/04ISR Number: 4443762-XReport Type:Periodic Company Report #US-JNJFOC-20030701223 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Risperdal Professional (Risperidone) PS 22-Feb-2006 08:20 AM Page: 2174 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4443767-9Report Type:Periodic Company Report #US-JNJFOC-20030701229 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Risperdal Professional (Risperidone) Tablets PS Date:07/29/04ISR Number: 4443773-4Report Type:Periodic Company Report #US-JNJFOC-20030700797 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal Initial or Prolonged Hallucination (Risperidone) PS Date:07/29/04ISR Number: 4443777-1Report Type:Periodic Company Report #US-JNJFOC-20030700583 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Consumer Risperdal Initial or Prolonged Drug Ineffective (Risperidone) PS Schizophrenia Date:07/29/04ISR Number: 4443779-5Report Type:Periodic Company Report #US-JNJFOC-20030700598 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Catatonia Consumer Risperdal Hallucination, Auditory (Risperidone) PS Suicide Attempt Date:07/29/04ISR Number: 4443781-3Report Type:Periodic Company Report #US-JNJFOC-20030600453 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Consumer Risperdal Attack (Risperidone) Tablets PS Date:07/29/04ISR Number: 4443783-7Report Type:Periodic Company Report #US-JNJFOC-20030600456 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatocellular Damage Health Risperdal Professional (Risperidone) Company Unspecified PS SEE IMAGE Representative Prozac (Fluoxetine Hydrochloride) C Date:07/29/04ISR Number: 4443825-9Report Type:Periodic Company Report #US-JNJFOC-20040400832 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Risperdal Initial or Prolonged (Risperidone) Tablets PS ORAL 2 MG, 2 IN 1 22-Feb-2006 08:20 AM Page: 2175 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY, ORAL Concerta (Methylphenidate Hydrochloride) Unspecified SS Date:07/29/04ISR Number: 4443826-0Report Type:Periodic Company Report #US-JNJFOC-20040306569 Age:18 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Attention Health Risperdal Weight Increased Professional (Risperidone) Unspecified PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL; 0.5 MG, 3 IN 1 DAY, ORAL Adderall Xr (Obetrol) C Adderall (Obetrol) C Allegra (Fexofenadine Hydrochloride) C Effexor (Venlafaxine Hydrochloride) C Buspar (Buspirone Hydrochloride) C Toporal Xl (Metoprolol Succinate) C Date:07/29/04ISR Number: 4443827-2Report Type:Periodic Company Report #US-JNJFOC-20040305938 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Self Injurious Behaviour Consumer Risperdal Initial or Prolonged Suicidal Ideation (Risperidone) Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL; 1 MG, 1 IN 1 DAY, ORAL; 1.5 MG, I 1 Lexapro (All Other Therapeutic Products) Tablets SS ORAL 10 MG, 1 IN 1 DAY, ORAL; 20 MG, 1 IN 1 DAY, ORAL; 30 MG, 1 IN 1 Date:07/29/04ISR Number: 4443830-2Report Type:Periodic Company Report #US-JNJFOC-20040305751 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Professional (Risperidone) Unspecified PS ORAL 4 MG, 1N 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 2176 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4443831-4Report Type:Periodic Company Report #US-JNJFOC-20040305727 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Health Risperdal Professional (Risperidone) Tablets PS ORAL , IN 1 DAY, ORAL Date:07/29/04ISR Number: 4443833-8Report Type:Periodic Company Report #US-JNJFOC-20040305462 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Risperdal (Risperidone) Unspecified PS Date:07/29/04ISR Number: 4443834-XReport Type:Periodic Company Report #US-JNJFOC-20040304613 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL Date:07/29/04ISR Number: 4443835-1Report Type:Periodic Company Report #US-JNJFOC-20040304617 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Health Risperdal Professional (Risperidone) Company Tablets PS ORAL 1 MG, IN 1 Representative DAY, ORAL Date:07/29/04ISR Number: 4443836-3Report Type:Periodic Company Report #US-JNJFOC-20040304619 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Health Risperdal Initial or Prolonged Professional (Risperidone) Company Unspecified PS ORAL ORAL Representative Date:07/29/04ISR Number: 4443837-5Report Type:Periodic Company Report #US-JNJFOC-20040304631 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Health Risperdal Increased Professional (Risperidone) Diabetes Mellitus Company Tablets PS ORAL 4 MG, IN 1 Representative DAY, ORAL; 2 MG, IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 2177 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4443838-7Report Type:Periodic Company Report #US-JNJFOC-20040302975 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cough Health Risperdal Initial or Prolonged Dyskinesia Professional (Risperidone) Orthostatic Hypotension Company Tablets PS ORAL ORAL Representative Thorazine (Chlorpromazine Hydrochloride) Tablets C Date:07/29/04ISR Number: 4443840-5Report Type:Periodic Company Report #US-JNJFOC-20040303442 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Professional (Risperidone) Company Unspecified PS ORAL ORAL Representative Date:07/29/04ISR Number: 4443842-9Report Type:Periodic Company Report #US-JNJFOC-20040302558 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone) Tablets PS ORAL 4 MG, IN 1 DAY, ORAL; 3 MG, IN 1 DAY, ORAL; 1 MG, 2 IN 1 Zoloft (Sertraline Hydrochloride) C Date:07/29/04ISR Number: 4443844-2Report Type:Periodic Company Report #US-JNJFOC-20040301612 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Health Risperdal Pancreatitis Professional (Risperidone) Tablets PS ORAL ORAL Date:07/29/04ISR Number: 4443846-6Report Type:Periodic Company Report #US-JNJFOC-20040301331 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperdal Initial or Prolonged Suicidal Ideation Professional (Risperidone) Company Unspecified PS ORAL 2 MG, 1 IN 1 Representative DAY, ORAL Prozac (Fluoxetine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 2178 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4443852-1Report Type:Periodic Company Report #US-JNJFOC-20040300090 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Risperdal Consta Extrapyramidal Disorder Professional (Risperidone) Tardive Dyskinesia Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Tablets SS ORAL 1 MG, 2 IN 1 DAY, ORAL; 1 MG, 1 IN 1 DAY, ORAL Trileptal (Oxcarbazepine) C Date:07/29/04ISR Number: 4443854-5Report Type:Periodic Company Report #US-JNJFOC-20040205768 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Consumer Risperdal Transient Ischaemic (Risperidone) Attack Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Exelon (Rivastigmine Tartrate) C Coumadin (Warfarin Sodium) C Date:07/29/04ISR Number: 4443858-2Report Type:Periodic Company Report #US-JNJFOC-20040205342 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 3 MG, 2 IN 1 DAY, ORAL Date:07/29/04ISR Number: 4443860-0Report Type:Periodic Company Report #US-JNJFOC-20040205003 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone) Company Tablets PS ORAL ORAL Representative Date:07/29/04ISR Number: 4443861-2Report Type:Periodic Company Report #US-JNJFOC-20040205125 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Risperdal Syndrome Professional (Risperidone) Company Tablets PS ORAL 2 MG, 1 IN 1 Representative DAY, ORAL 22-Feb-2006 08:20 AM Page: 2179 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Reglan (Metoclopramide) C Date:07/29/04ISR Number: 4443866-1Report Type:Periodic Company Report #US-JNJFOC-20040504845 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 5 MG, IN 1 DAY, ORAL Date:07/29/04ISR Number: 4443867-3Report Type:Periodic Company Report #US-JNJFOC-20040504846 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 0.25 MG, IN 1 DAY, ORAL Date:07/29/04ISR Number: 4443873-9Report Type:Periodic Company Report #US-JNJFOC-20040504022 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal Professional (Risperidone) Company Tablets PS ORAL ORAL Representative Date:07/29/04ISR Number: 4443875-2Report Type:Periodic Company Report #US-JNJFOC-20040502817 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Health Risperdal Initial or Prolonged Professional (Risperidone) Tablets PS ORAL 4 MG, 1 IN 1 DAY, ORAL Valium (Diazepam) C Date:07/29/04ISR Number: 4443879-XReport Type:Periodic Company Report #US-JNJFOC-20040406527 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Consumer Risperdal Health (Risperidone) Professional Tablets PS Date:07/29/04ISR Number: 4443882-XReport Type:Periodic Company Report #US-JNJFOC-20040406490 Age:76 YR Gender:Female I/FU:I Outcome PT Other Glucose Tolerance Impaired Lethargy 22-Feb-2006 08:20 AM Page: 2180 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Migraine Nightmare Report Source Product Role Manufacturer Route Dose Duration Consumer Risperdal (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Ambien (Zolpidem Tartrate) C Date:07/29/04ISR Number: 4443885-5Report Type:Periodic Company Report #US-JNJFOC-20040405811 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Professional (Risperidone) Company Tablets PS ORAL 1 MG, 1 IN 1 Representative DAY, ORAL Date:07/29/04ISR Number: 4443887-9Report Type:Periodic Company Report #US-JNJFOC-20040405816 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Risperdal (Risperidone) Unspecified PS Date:07/29/04ISR Number: 4443891-0Report Type:Periodic Company Report #US-JNJFOC-20040405281 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR INTRAMUSCULAR Representative Risperdal (Risperidone) Tablets SS ORAL ORAL Date:07/29/04ISR Number: 4443893-4Report Type:Periodic Company Report #US-JNJFOC-20040402377 Age:7 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Health Risperdal Initial or Prolonged Professional (Risperidone) Unspecified PS ORAL 2 MG, ORAL Zoloft (Sertraline Hydrochloride) C Date:07/29/04ISR Number: 4443895-8Report Type:Periodic Company Report #US-JNJFOC-20040405218 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 2181 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4443896-XReport Type:Periodic Company Report #US-JNJFOC-20030604430 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Consumer Risperdal Initial or Prolonged Convulsion (Risperidone) Tablets PS ORAL 3 MG, 1 IN 1 DAY, ORAL Date:07/29/04ISR Number: 4443898-3Report Type:Periodic Company Report #US-JNJFOC-20040404500 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Risperdal Initial or Prolonged Professional (Risperidone) Tablets PS ORAL 2 MG, ORAL Risperdal Consta (Risperidone) Microspheres SS INTRAMUSCULAR INTRA-MUSCULA R Date:07/29/04ISR Number: 4443900-9Report Type:Periodic Company Report #US-JNJFOC-20040404437 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Risperdal Diabetes Mellitus Professional (Risperidone) PS ORAL Insomnia Depakote (Valproate Sedation Semisodium) C Keppra (Levetiracetam) C Date:07/29/04ISR Number: 4443901-0Report Type:Periodic Company Report #US-JNJFOC-20030604426 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Myocardial Infarction Health Risperdal Initial or Prolonged Professional (Risperidone) Company Tablets PS 1 MG, 5 IN 1 Representative DAY Date:07/29/04ISR Number: 4443903-4Report Type:Periodic Company Report #US-JNJFOC-20040404091 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Risperdal Decreased Professional (Risperidone) Tablets PS ORAL 6 MG, 1 IN 1 DAY, ORAL Date:07/29/04ISR Number: 4443904-6Report Type:Periodic Company Report #US-JNJFOC-20030603248 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Consumer Risperdal Attack (Risperidone) Unspecified PS ORAL 1 MG, 2 IN 1 22-Feb-2006 08:20 AM Page: 2182 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY, ORAL Date:07/29/04ISR Number: 4443905-8Report Type:Periodic Company Report #US-JNJFOC-20040404168 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Risperdal Drooling (Risperidone) PS Myocardial Infarction Date:07/29/04ISR Number: 4443906-XReport Type:Periodic Company Report #US-JNJFOC-20040404171 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal Consta Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR SEE IMAGE Representative Risperdal (Risperidone) Tablets SS ORAL Date:07/29/04ISR Number: 4443907-1Report Type:Periodic Company Report #US-JNJFOC-20030602269 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Consumer Risperdal White Blood Cell Count (Risperidone) Decreased Unspecified PS SEE IMAGE Depakote (Valproate Semisodium) C Strattera (All Other Therapeutic Products) C Date:07/29/04ISR Number: 4443908-3Report Type:Periodic Company Report #US-JNJFOC-20040404230 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Risperdal Professional (Risperidone) Tablets PS ORAL 3 MG, 2 IN 1 DAY, ORAL Date:07/29/04ISR Number: 4443909-5Report Type:Periodic Company Report #US-JNJFOC-20040403202 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal Professional (Risperidone) Tablets PS ORAL SEE IMAGE 22-Feb-2006 08:20 AM Page: 2183 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4443910-1Report Type:Periodic Company Report #US-JNJFOC-20030602306 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Health Risperdal Initial or Prolonged Pregnancy Professional (Risperidone) Psychotic Disorder Unspecified PS 1 MG, 2 IN 1 DAY Date:07/29/04ISR Number: 4443911-3Report Type:Periodic Company Report #US-JNJFOC-20040402820 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Health Risperdal Prolonged Professional (Risperidone) Tablets PS ORAL SEE IMAGE Imipramine (Imipramine) C Strattera (All Other Therapeutic Products) C Date:07/29/04ISR Number: 4443912-5Report Type:Periodic Company Report #US-JNJFOC-20040402108 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Consumer Risperdal Initial or Prolonged (Risperidone) Tablets PS ORAL ORAL Prednisone (Prednisone) SS ORAL ORAL Date:07/29/04ISR Number: 4443913-7Report Type:Periodic Company Report #US-JNJFOC-20030601830 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatinine Health Risperdal Increased Professional (Risperidone) Blood Prolactin Increased Unspecified PS 0.5 MG, 2 IN Blood Urea Increased 1 DAY White Blood Cell Count Depakote (Valproate Decreased Semisodium) C Prozac ( Fluoxetine Hydrochloride) C Date:07/29/04ISR Number: 4443914-9Report Type:Periodic Company Report #US-JNJFOC-20030601831 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Risperdal Initial or Prolonged Myocardial Infarction (Risperidone) Oedema Peripheral Tablets PS 1 MG, 1 IN 1 DAY 22-Feb-2006 08:20 AM Page: 2184 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4443915-0Report Type:Periodic Company Report #US-JNJFOC-20030601222 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal Platelet Count Decreased Professional (Risperidone) Tablets PS SEE IMAGE Date:07/29/04ISR Number: 4443916-2Report Type:Periodic Company Report #NSADSS2003006166 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperdal Initial or Prolonged Professional (Risperidone) Tablets PS ORAL 6 MG, 1 IN 1 DAY, ORAL Interferon C Date:07/29/04ISR Number: 4443917-4Report Type:Periodic Company Report #NSADSS2003019078 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Health Risperdal Attack Professional (Risperidone) Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Reminyl (Unspecified) Galantamine C Zoloft (Tablets) Sertraline Hydrochloride Tablets C Periactin (Cyproheptadine Hydrochloride) C Baby Aspirin (Acetylsalicylic Acid) C Ditropan (Oxybutynin) C Date:07/29/04ISR Number: 4443919-8Report Type:Periodic Company Report #NSADSS2003019733 Age:6 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Risperdal (Risperidone) Tablets PS ORAL 0.25 MG, 2 IN 24 HOUR, ORAL Date:07/29/04ISR Number: 4443920-4Report Type:Periodic Company Report #NSADSS2003019998 Age:97 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Transient Ischaemic Consumer Risperdal Initial or Prolonged Attack Health (Risperidone) Professional Tablets PS ORAL 0.5 MG, 1 IN 22-Feb-2006 08:20 AM Page: 2185 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 24 HOUR, ORAL Hctz-Reserpine (Hydrochlorothiazide ) C Norvasc (Amlodipine Besilate) C Atenolol C Nitro (Glyceryl Trinitrate) C Famotidine C Amitriptyline C Salsalate C Citricel (All Other Therapeutic Products) C Date:07/29/04ISR Number: 4443923-XReport Type:Periodic Company Report #NSADSS2003021460 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Transient Ischaemic Health Risperdal Attack Professional (Risperidone) Company Tablets PS ORAL 0.25 MG, 1 IN Representative 1 DAY, ORAL Synthroid (Levothyroxine Sodium) C Aspirin (Acetylsalicylic Acid) C Vitamin E (Tocopherol) C Calcium C Paxil (Paroxetine Hydrochloride) C Centrum Silver C Lisinopril C Tylenol (Paracetamol) C Date:07/29/04ISR Number: 4443924-1Report Type:Periodic Company Report #US-JNJFOC-20030600070 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Health Risperdal Cerebrovascular Accident Professional (Risperidone) Company Unspecified PS ORAL ORAL Representative Date:07/29/04ISR Number: 4443925-3Report Type:Periodic Company Report #NSADSS2003022069 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, 2 IN 24 HOUR, ORAL Lithobid (Lithium Carbonate) C 22-Feb-2006 08:20 AM Page: 2186 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ativan (Lorazepam) C Date:07/29/04ISR Number: 4443926-5Report Type:Periodic Company Report #US-JNJFOC-20030600176 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Health Risperdal Hospitalization - Professional (Risperidone) Initial or Prolonged Company Tablets PS ORAL 1 MG, ORAL Representative Date:07/29/04ISR Number: 4443927-7Report Type:Periodic Company Report #NSADSS2003002707 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Risperdal Initial or Prolonged Constipation (Risperidone) Disability Depression Unspecified PS ORAL 6 MG, ORAL; 1 Dysuria MG, ORAL; 1MG Fatigue WITH TAPER Muscle Fatigue INCREASES 1MG Suicidal Ideation PER WEEK; 4 Suicide Attempt Celexa (Citalopram Hydrobromide) C Clozaril (Clozapine) C Thiothixene (Tiotixene) C Date:07/29/04ISR Number: 4443928-9Report Type:Periodic Company Report #NSADSS2003005699 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Risperdal Syndrome Professional (Risperidone) Tablets PS ORAL 1 MG, 2 IN 1 DAY, ORAL Adderall (Obetrol) C Date:07/29/04ISR Number: 4443929-0Report Type:Periodic Company Report #US-JNJFOC-20030803113 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Initial or Prolonged Syndrome Professional (Risperidone) Tablets PS ORAL ORAL Date:07/29/04ISR Number: 4443930-7Report Type:Periodic Company Report #NSADSS2002026047 Age:77 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperdal Initial or Prolonged Professional (Risperidone) Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Study Medication (Thiazides) SS 22-Feb-2006 08:20 AM Page: 2187 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Placebo (Placebo) SS Glucotrol (Glipizide) C Glucophage (Unspecified) Metformin Hydrochloride C Calan Sr (Verapamil Hydrochloride) Unspecified C Date:07/29/04ISR Number: 4443931-9Report Type:Periodic Company Report #NSADSS2002009796 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Contusion Consumer Risperdal Full Blood Count Health (Risperidone) Decreased Professional Tablets PS ORAL SEE IMAGE Thrombocytopenia Synthroid (Levothyroxine Sodium) C Restoril (Temazepam) C Date:07/29/04ISR Number: 4443934-4Report Type:Periodic Company Report #NSADSS2002016388 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Risperdal Hospitalization - Syndrome Professional (Risperidone) Initial or Prolonged Company Tablets PS ORAL SEE IMAGE Representative Lavox (All Other Therapeutic Products) C Cogentin (Benzatropine Mesilate) C Anafranil (Clomipramine Hydrochloride) C Date:07/29/04ISR Number: 4443938-1Report Type:Periodic Company Report #NSADSS2002008155 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL ORAL Date:07/29/04ISR Number: 4443940-XReport Type:Periodic Company Report #NSADSS2002001971 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal Initial or Prolonged Agitation (Risperidone) Disturbance In Attention Solution PS ORAL SEE IMAGE Sedation Tegretol (Carbamazepine) C 22-Feb-2006 08:20 AM Page: 2188 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Albuterol (Salbutamol) C Paxil (Paroxetine Hydrochloride) C Topamax (Topiramate) C Mestinon (Pyridostigmine Bromide) C Date:07/29/04ISR Number: 4443941-1Report Type:Periodic Company Report #NSADSS2001020632 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal Professional (Risperidone) Tablets PS ORAL SEE IMAGE Tegretol (Carbamazepine) C Clonidine (Clonidine) C Ativan (Lorazepam) C Date:07/29/04ISR Number: 4443942-3Report Type:Periodic Company Report #US-JNJFOC-20030801772 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tic Risperdal Initial or Prolonged Transient Ischaemic (Risperidone) Attack Tablets PS ORAL 0.25 MG, 2 IN 1 DAY, ORAL Zoloft (Sertraline Hydrochloride) C Date:07/29/04ISR Number: 4443943-5Report Type:Periodic Company Report #US-JNJFOC-20040505895 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, 1 IN 1 DAY, ORAL Depakote Er (Tablets) Valproate Semisodium C Date:07/29/04ISR Number: 4443945-9Report Type:Periodic Company Report #US-JNJFOC-20030801769 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Professional (Risperidone) Company Tablets PS ORAL ORAL Representative 22-Feb-2006 08:20 AM Page: 2189 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4443946-0Report Type:Periodic Company Report #US-JNJFOC-20040505908 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Trismus Health Risperdal Initial or Prolonged Professional (Risperidone) Company Unspecified PS ORAL 8 MG, ORAL Representative Date:07/29/04ISR Number: 4443947-2Report Type:Periodic Company Report #US-JNJFOC-20030801480 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperdal Initial or Prolonged Professional (Risperidone) Company Tablets PS 0.5 MG Representative TABLET, DAILY DOSE UNSPECIFIED Date:07/29/04ISR Number: 4443948-4Report Type:Periodic Company Report #US-JNJFOC-20040505758 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Health Risperdal Priapism Professional (Risperidone) Solution PS ORAL SEE IMAGE Neurontin (Gabapentin) C Lamictal (Lamotrigine) C Paxil (Paroetine Hydrochloride) C Date:07/29/04ISR Number: 4443950-2Report Type:Periodic Company Report #US-JNJFOC-20040505767 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Risperdal Depression Professional (Risperidone) PS Vision Blurred Rebif (Interferon Beta) SS INTRAVENOUS 44 UG, 3 IN 1 WEEK, INTRVENOUS (NOT OTHERWISE Alprazolam (Alprazolam) SS Date:07/29/04ISR Number: 4443951-4Report Type:Periodic Company Report #US-JNJFOC-20030707673 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Risperdal Phosphokinase Increased Professional (Risperidone) Liver Function Test Tablets PS ORAL ORAL Abnormal 22-Feb-2006 08:20 AM Page: 2190 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4443953-8Report Type:Periodic Company Report #US-JNJFOC-20040505538 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Consumer Risperdal Initial or Prolonged (Risperidone) Tablets PS ORAL 2 MG, 4 IN 1 DAY, ORAL Effexor (Venlafaxine Hydrochloride) SS PATIENTS TOOK 17 TABLETS Seroquel (Quetiapine Fumarate) C Strattera (All Other Therapuetic Products) C Depakote (Valproate Semisodium) C Synthroid (Levothyroxine Sodium) C Wellbutrin (Bupropion Hydrochloride) C Abilify (Aripiprazole) C Date:07/29/04ISR Number: 4443955-1Report Type:Periodic Company Report #US-JNJFOC-20030705444 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Difficulty In Walking Consumer Risperdal Initial or Prolonged Flat Affect (Risperidone) Pneumonia Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Paxil (Paroxetine Hydrochloride) C Tegretol (Carbamazepine) C Date:07/29/04ISR Number: 4443956-3Report Type:Periodic Company Report #US-JNJFOC-20030705483 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Schizophrenia Professional (Risperidone) PS ORAL Date:07/29/04ISR Number: 4443957-5Report Type:Periodic Company Report #US-JNJFOC-20040302224 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Reaction Health Risperdal Consta Nasopharyngitis Professional (Risperidone) Microspheres PS INTRAMUSCULAR , 1 IN 2 WEEK, INTRA-MUSCULA R Haldol (Haliperidol) Tablets C 22-Feb-2006 08:20 AM Page: 2191 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neutontin (Gabapentin) Tablets C Klonopin (Clonazepam) Tablets C Wellbutrin (Bupropion Hydrochloride) C Date:07/29/04ISR Number: 4443959-9Report Type:Periodic Company Report #US-JNJFOC-20040300520 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Consta Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR , 1 IN 2 Representative WEEK, INTRA-MUSCULA R Date:07/29/04ISR Number: 4443960-5Report Type:Periodic Company Report #US-JNJFOC-20030705539 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Initial or Prolonged Syndrome Professional (Risperidone) Psychotic Disorder Tablets PS 3-9 MG DAILY Clozapine (Clozapine) SS 25 MG, 1 IN 1 DAY Cognentin (Benzatropine Mesilate) C Stelazine (Trifluoperazine Hydrochloride) C Lithium (Lithium) C Date:07/29/04ISR Number: 4443961-7Report Type:Periodic Company Report #US-JNJFOC-20040300090 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Risperdal Consta Extrapyramidal Disorder Professional (Risperidone) Tardive Dyskinesia Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Tablets SS ORAL 1 MG, 2 IN 1 DAY, ORAL Trileptal (Oxcarbazepine) C 22-Feb-2006 08:20 AM Page: 2192 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4443963-0Report Type:Periodic Company Report #US-JNJFOC-20040204970 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Health Risperdal Consta Hypotension Professional (Risperidone) Medication Error Microspheres PS ORAL 37.5 MG, 1 IN Somnolence 2 WEEK, ORAL . C Date:07/29/04ISR Number: 4443964-2Report Type:Periodic Company Report #US-JNJFOC-20030705677 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Consumer Risperdal Initial or Prolonged Joint Swelling (Risperidone) Somnolence Tablets PS ORAL 1.5 MG, 1 IN 1 DAY, ORAL Date:07/29/04ISR Number: 4443965-4Report Type:Periodic Company Report #US-JNJFOC-20040202341 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Consta Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Representative WEEK, INTRA-MUSCULA R Risperdal (Risperidone) SS UP TO 10.0 MG PER DAY Date:07/29/04ISR Number: 4443968-XReport Type:Periodic Company Report #US-JNJFOC-20040200235 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal Consta Initial or Prolonged Schizophrenia Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR INTRA-MUSCULA Representative R . C Date:07/29/04ISR Number: 4443969-1Report Type:Periodic Company Report #US-JNJFOC-20030704993 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Health Risperdal Initial or Prolonged Increased Professional (Risperidone) Musculoskeletal Stiffness Company Tablets PS ORAL ORAL Neuroleptic Malignant Representative Paxil (Paroxetine Syndrome Hydrochloride) SS Tachycardia Geodon (Ziprasidone Hydrochloride) SS 60 MG, 2 IN 1 DAY Zyprexa (Olanzapine) SS 22-Feb-2006 08:20 AM Page: 2193 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4443970-8Report Type:Periodic Company Report #US-JNJFOC-20040105716 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Consumer Risperdal Consta Initial or Prolonged Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:07/29/04ISR Number: 4443973-3Report Type:Periodic Company Report #US-JNJFOC-20040105734 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Health Risperdal Consta Initial or Prolonged Musculoskeletal Stiffness Professional (Risperidone) Psychomotor Skills Company Microspheres PS INTRAMUSCULAR 25 MG, Impaired Representative INTRA-MUSCULA R Cogentin (Benzatropine Mesilate) C Date:07/29/04ISR Number: 4443975-7Report Type:Periodic Company Report #US-JNJFOC-20040506431 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Consumer Risperdal Initial or Prolonged Dyskinesia (Risperidone) Tardive Dyskinesia Unspecified PS ORAL SEE IMAGE Strattera (All Other Therapeutic Products) C Zyprexa (All Other Therapeutic Products) C Zyprexa (Olanzapine) C Zoloft (Sertraline Hydrochloride) C Date:07/29/04ISR Number: 4443977-0Report Type:Periodic Company Report #US-JNJFOC-20040506445 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Risperdal (Risperidone) Tablets PS ORAL ORAL Date:07/29/04ISR Number: 4443979-4Report Type:Periodic Company Report #US-JNJFOC-20030906141 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Initial or Prolonged Syndrome Professional (Risperidone) PS ORAL 1 MG, 2 IN 1 DAY, ORAL Dilantin (Phenytoin Sodium) C 22-Feb-2006 08:20 AM Page: 2194 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4443980-0Report Type:Periodic Company Report #US-JNJFOC-20030904905 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal Initial or Prolonged Depression (Risperidone) PS ORAL 1 MG, 1 IN 1 Suicidal Ideation DAY, ORAL Adderall (Obetrol) C Date:07/29/04ISR Number: 4443981-2Report Type:Periodic Company Report #US-JNJFOC-20030905304 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperidone Initial or Prolonged Professional (Risperidone) Tablets PS ORAL 1 DOSE(S), 1 IN 1 DAY, ORAL; 1 DOSE(S), 2 IN 1 DAY, ORAL Depakote Er (Valproate Semisodium) Tablets SS ORAL , 2 IN 1 DAY, ORAL, 3 IN 1 DAY, ORAL Fluticasone Priopionate (Fluticasone Propionate) C Salmeterol Xinafoate (Salmeterol Xinafoate) C Ibuprofen (Ibuprofen) C Date:07/29/04ISR Number: 4443983-6Report Type:Periodic Company Report #US-JNJFOC-20030904545 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Consumer Risperdal Initial or Prolonged Haemorrhoids (Risperidone) Intentional Overdose Tablets PS ORAL 2 MG, 4 IN 1 Suicide Attempt DAY, ORAL Date:07/29/04ISR Number: 4443984-8Report Type:Periodic Company Report #US-JNJFOC-20030904548 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal Professional (Risperidone) Tablets PS ORAL 3 MG, 1 IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 2195 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4443986-1Report Type:Periodic Company Report #US-JNJFOC-20030904550 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Risperdal Professional (Risperidone) Company Tablets PS ORAL ORAL Representative Date:07/29/04ISR Number: 4443988-5Report Type:Periodic Company Report #US-JNJFOC-20030904437 Age:50 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthralgia Consumer Risperdal Condition Aggravated Health (Risperidone) PS ORAL SEE IMAGE Depressed Mood Professional Amitriptyline Diabetes Mellitus (Amitriptyline) C Disturbance In Attention Atrax (Hydroxyzine Dyskinesia Hydrochloride) C Hallucination Oxycontin (Oxycodone Headache Hydrochloride) C Increased Appetite Limbitrol Muscle Spasms (Limbitrol) C Pain In Extremity Neurontin Paranoia (Gabapentin) C Suicidal Ideation Weight Increased Date:07/29/04ISR Number: 4443990-3Report Type:Periodic Company Report #US-JNJFOC-20030903284 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Professional (Risperidone) Tablets PS ORAL 0.75 MG, 1 IN 1 DAY, ORAL Date:07/29/04ISR Number: 4443992-7Report Type:Periodic Company Report #US-JNJFOC-20030902186 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Non-Insulin-Dependent Professional (Risperidone) Company Tablets PS ORAL 0.5 MG , 1 IN Representative 1 DAY, ORAL ... C Neurontin (Gabapentin) Tablets C Effexor (Venlfaxine Hydrochloride) Tablets C Wellbutrin (Bupropion Hydrochloride) Tablets C 22-Feb-2006 08:20 AM Page: 2196 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4443993-9Report Type:Periodic Company Report #US-JNJFOC-20030902469 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Risperdal Decreased Professional (Risperidone) Tablets PS ORAL 3 MG, 1 IN 1 DAY, ORAL Date:07/29/04ISR Number: 4443995-2Report Type:Periodic Company Report #US-JNJFOC-20031005694 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Health Risperdal Hallucination, Auditory Professional (Risperidone) Muscle Spasms Tablets PS ORAL 2 MG, IN 1 Sedation DAY, ORAL; Tardive Dyskinesia 1.5 MG, IN Tic 1 DAY, ORAL; 2 MG, IN 1 Lithium (Lithium) C Klonopin (Clonazepam) C Date:07/29/04ISR Number: 4443996-4Report Type:Periodic Company Report #US-JNJFOC-20031004786 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholelithiasis Consumer Risperdal Psoriasis (Risperidone) Tablets PS ORAL 0.25 MG, 2 IN 1 D, ORAL Wellbutrin (Bupropion Hydrochloride) C Date:07/29/04ISR Number: 4443997-6Report Type:Periodic Company Report #US-JNJFOC-20031003639 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL Reminyl (Galantamine) C Date:07/29/04ISR Number: 4444000-4Report Type:Periodic Company Report #US-JNJFOC-20031003642 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Initial or Prolonged Syndrome Professional (Risperidone) Company Tablets PS ORAL 3 MG, 1 IN 1 Representative DAY, ORAL Lithium (Lithium) C 22-Feb-2006 08:20 AM Page: 2197 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4444001-6Report Type:Periodic Company Report #US-JNJFOC-20031003653 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Health Risperdal Convulsion Professional (Risperidone) Company Tablets PS ORAL 4 MG, 1 IN 1 Representative DAY, ORAL Date:07/29/04ISR Number: 4444003-XReport Type:Periodic Company Report #US-JNJFOC-20031003880 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Health Risperdal Abnormal Professional (Risperidone) Unspecified PS ORAL 3 MG, 2 IN 1 DAY, ORAL Lipitor (Atorvastatin) C Date:07/29/04ISR Number: 4444004-1Report Type:Periodic Company Report #US-JNJFOC-20031004572 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Consumer Risperdal Initial or Prolonged Somnolence (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Date:07/29/04ISR Number: 4444007-7Report Type:Periodic Company Report #US-JNJFOC-20030906650 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Health Risperdal Initial or Prolonged Pulmonary Embolism Professional (Risperidone) Tablets PS ORAL 2.5 MG, 1 IN 1 DAY, ORAL Lithium (Lithium) SS 1500 MG, 1 IN 1 DAY Escitalopram Oxalate (All Other Therapeutic Products) SS 10 MG, 1 IN 1 DAY Date:07/29/04ISR Number: 4444010-7Report Type:Periodic Company Report #US-JNJFOC-20030902472 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Risperdal Syndrome Professional (Risperidone) Unspecified PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 2198 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4444012-0Report Type:Periodic Company Report #US-JNJFOC-20030901354 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal Professional (Risperidone) Tablets PS ORAL 2.5 MG, 1 IN 1 DAY, ORAL Nadolol (Nadolol) C Date:07/29/04ISR Number: 4444014-4Report Type:Periodic Company Report #US-JNJFOC-20031103764 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Health Risperdal Initial or Prolonged Loss Of Consciousness Professional (Risperidone) Other Company Tablets PS ORAL 12 MG, IN Representative 1 DAY, ORAL Haldol (Haloperidol) C Cogentin (Benzatropine Mesilate) C Date:07/29/04ISR Number: 4444016-8Report Type:Periodic Company Report #US-JNJFOC-20031104044 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Iron Deficiency Anaemia Health Risperdal Professional (Risperidone) Unspecified PS Date:07/29/04ISR Number: 4444018-1Report Type:Periodic Company Report #US-JNJFOC-20031103131 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Health Risperdal Professional (Risperidone) Company Tablets PS ORAL 0.5 MG, 1 IN Representative 1 DAY, ORAL; 1 MG, 1 IN 1 DAY, ORAL Date:07/29/04ISR Number: 4444019-3Report Type:Periodic Company Report #US-JNJFOC-20031102909 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, 1 IN 1 DAY, ORAL Date:07/29/04ISR Number: 4444021-1Report Type:Periodic Company Report #US-JNJFOC-20031102881 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetic Ketoacidosis Health Risperdal Professional (Risperidone) 22-Feb-2006 08:20 AM Page: 2199 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unspecified PS 0.25 MG, Date:07/29/04ISR Number: 4444023-5Report Type:Periodic Company Report #US-JNJFOC-20031102837 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Risperdal Initial or Prolonged Professional (Risperidone) Company Unspecified PS PATIENT USED Representative THIS DRUG 2-3 DAYS 3 DAY Date:07/29/04ISR Number: 4444024-7Report Type:Periodic Company Report #US-JNJFOC-20031102841 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Weight Increased Professional (Risperidone) Unspecified PS Levoxyl (Levothyroxine Sodium) C Anti-Depressants (Antidepressants) C Date:07/29/04ISR Number: 4444025-9Report Type:Periodic Company Report #US-JNJFOC-20031102412 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Professional (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Prozac (Fluoxetine Hydrochloride) C Date:07/29/04ISR Number: 4444026-0Report Type:Periodic Company Report #US-JNJFOC-20031102278 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Consumer Risperdal Initial or Prolonged Syndrome (Risperidone) Psychotic Disorder Tablets PS ORAL ORAL Date:07/29/04ISR Number: 4444027-2Report Type:Periodic Company Report #US-JNJFOC-20031102314 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Consumer Risperdal Chest Pain Health (Risperidone) Dizziness Professional Tablets PS ORAL 0.5 MG, 1 IN Tardive Dyskinesia 1 DAY, ORAL Concerta (Methylphenidate Hydrochloride) C 22-Feb-2006 08:20 AM Page: 2200 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4444028-4Report Type:Periodic Company Report #US-JNJFOC-20031200017 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Flutter Health Risperdal Diabetes Mellitus Professional (Risperidone) Vaginal Infection Tablets PS ORAL 0.5 MG, IN 1 DAY, ORAL Lorazepam (Lorazepam) C Diovan (Valsartan) C Diltiazem (Diltiazem) C Prozac (Fluoxetine Hydrochloride) C Date:07/29/04ISR Number: 4444030-2Report Type:Periodic Company Report #US-JNJFOC-20031200019 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colonic Polyp Health Risperdal Renal Failure Professional (Risperidone) Tablets PS ORAL 5.5 MG, IN 1 DAY, ORAL Robitussin(Guaifenes in) C ... C Milk Of Magnesia (Magnesium Hydroxide) C Augmenti (Clavulin) C Zantac (Ranitidine Hydrochloride) C Ferrous Sulfte (Ferrous Sulfate) C Protonix (Pantoprazole) C Date:07/29/04ISR Number: 4444031-4Report Type:Periodic Company Report #US-JNJFOC-20031105255 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Risperdal Dysphagia (Risperidone ) Hyperhidrosis Tablets PS ORAL 4 MG, 1 IN1 Mastication Disorder DAY, ORAL Muscle Twitching Elavil (Amitriptyline Hydrochloride) C Ambien (Zolpidem Tartrate) C Date:07/29/04ISR Number: 4444033-8Report Type:Periodic Company Report #US-JNJFOC-20031104903 Age: Gender:Male I/FU:I Outcome PT Report Source Other Neuroleptic Malignant Health Syndrome Professional Company 22-Feb-2006 08:20 AM Page: 2201 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Risperdal (Risperidone ) PS Date:07/29/04ISR Number: 4444035-1Report Type:Periodic Company Report #US-JNJFOC-20031104376 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone ) Company Tablets PS ORAL SEE IMAGE Representative Trazadone (Trazodone) C Date:07/29/04ISR Number: 4444037-5Report Type:Periodic Company Report #US-JNJFOC-20031104473 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Risperdal Initial or Prolonged Non-Insulin-Dependent Professional (Risperidone ) Tablets PS ORAL 2 MG , IN 1 DAY, ORAL Glyburride (Glibenclamide) C Metformin (Metformin) C Lisinopril (Lisonipril) C Simvastatin (Simvastatin) C Date:07/29/04ISR Number: 4444040-5Report Type:Periodic Company Report #US-JNJFOC-20031102026 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Mental Impairment Health Risperdal Tardive Dyskinesia Professional (Risperidone ) PS ORAL ORAL Company Representative Date:07/29/04ISR Number: 4444042-9Report Type:Periodic Company Report #US-JNJFOC-20031101381 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal Initial or Prolonged Intentional Overdose Professional (Risperidone ) PS Date:07/29/04ISR Number: 4444044-2Report Type:Periodic Company Report #US-JNJFOC-20031100989 Age:3 YR Gender:Male I/FU:I Outcome PT Report Source Other Tardive Dyskinesia Health Professional Company 22-Feb-2006 08:20 AM Page: 2202 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Risperdal (Risperidone ) Tablets PS ORAL 0.25 MG, 2 IN 1 DAY, ORAL Depakote (Valproate Semisodium) C Klonopin (Clonazepam) C Date:07/29/04ISR Number: 4444047-8Report Type:Periodic Company Report #US-JNJFOC-20031006232 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Risperdal Electrocardiogram Qt Professional (Risperidone ) Corrected Interval Tablets PS ORAL SEE IMAGE Hypotension Celebrex (Celecoxib) SS ORAL 100 MG, 1 IN Orthostatic Hypotension 1 DAY, ORAL Allegra (Fexofenadine Hydrochloride) C Aspirin (Acetylsalicylic Acid) C Senokot S (Senokot-S) C Duragesic (Fentanyl) Patch C Neurontin (Gabapentin) C Flonase (Fluticasone Propionate) C Medrol (Methylprednisolone) C Dilantin (Phenytoin Sodium) C Exelon (Rivastigmine Tartrate) C Date:07/29/04ISR Number: 4444050-8Report Type:Periodic Company Report #US-JNJFOC-20040104074 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Consumer Risperdal Initial or Prolonged Hallucination (Risperidone) Tablets PS ORAL SEE IMAGE Zyprexa (Olanzapine) C Date:07/29/04ISR Number: 4444051-XReport Type:Periodic Company Report #US-JNJFOC-20040104083 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Risperdal Muscle Spasms (Risperidone) Tablets PS ORAL 2 MG, 1 IN 1 22-Feb-2006 08:20 AM Page: 2203 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAY, ORAL Doxepin (Doxepin) C Synthroid (Levothyroxine Sodium) C Mevacor (Lovastatin) C Metformin (Metformin) C Date:07/29/04ISR Number: 4444052-1Report Type:Periodic Company Report #US-JNJFOC-20040103497 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone) Tablets PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Paxil (Paroxetine Hydrochloride) Tablets C Date:07/29/04ISR Number: 4444054-5Report Type:Periodic Company Report #US-JNJFOC-20040103666 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal (Risperidone) Tablets PS ORAL 1.5 MG, 1 IN 1 DAY, ORAL Date:07/29/04ISR Number: 4444056-9Report Type:Periodic Company Report #US-JNJFOC-20040103057 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal Professional (Risperidone) PS ORAL 4 MG, 1 IN 1 DAY, ORAL Date:07/29/04ISR Number: 4444057-0Report Type:Periodic Company Report #US-JNJFOC-20040102224 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Consumer Risperdal (Risperidone) Tablets PS ORAL 2 MG, 1 IN 1 DAY, ORAL Vitamin E (Tocopherol) Capsules C Verapamil (Verapamil) C Potaba (Potassium Aminobenzoate) Tablets C 22-Feb-2006 08:20 AM Page: 2204 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4444058-2Report Type:Periodic Company Report #US-JNJFOC-20040102666 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Risperdal Health (Risperidone) Professional Tablets PS ORAL 2 MG, 1 IN 1 DAY, ORAL Seroquel (Quetiapine Fumarate) C Wellbutrin Sr (Bupropion Hydrochloride) C Eskalith Cr (Lithium Carbonate) C Date:07/29/04ISR Number: 4444060-0Report Type:Periodic Company Report #US-JNJFOC-20040101490 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Arrest Consumer Risperdal Initial or Prolonged Cerebrovascular Accident Health (Risperidone) Diarrhoea Professional Tablets PS ORAL SEE IMAGE Erectile Dysfunction Metoprolol Hallucination, Visual (Metoprolol) C Insomnia Aspirin Migraine (Acetylsalicylic Acid) C Amlodipine (Amlodipine) C Haldol Decanoate (Haloperidol Decanoate) Injection C Date:07/29/04ISR Number: 4444061-2Report Type:Periodic Company Report #US-JNJFOC-20040101494 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Risperdal Initial or Prolonged Weight Increased Professional (Risperidone) PS SEE IMAGE Other Zantac (Ranitidine Hydrochloride) C Norvasc (Amlodipine Besilate) C Vasotec (Enalapril Maleate) C Lescol (Fluvastatin Sodium) C Date:07/29/04ISR Number: 4444063-6Report Type:Periodic Company Report #US-JNJFOC-20040101717 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Spasms Consumer Risperdal Initial or Prolonged Nightmare (Risperidone) Parkinsonism Tablets PS ORAL ORAL Pneumonia Suicidal Ideation Tachycardia 22-Feb-2006 08:20 AM Page: 2205 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4444064-8Report Type:Periodic Company Report #US-JNJFOC-20031203264 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Risperdal Professional (Risperidone) Tablets PS ORAL ORAL Date:07/29/04ISR Number: 4444065-XReport Type:Periodic Company Report #US-JNJFOC-20031203125 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone) PS Date:07/29/04ISR Number: 4444066-1Report Type:Periodic Company Report #US-JNJFOC-20031203138 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Risperdal (Risperidone) Tablets PS ORAL 2 MG 1 IN 1 DAY ORAL Celexa (Citalopram Hydrobromide) C Date:07/29/04ISR Number: 4444067-3Report Type:Periodic Company Report #US-JNJFOC-20031203149 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaphylactic Shock Health Risperdal Initial or Prolonged Professional (Risperidone) Tablets PS ORAL 3 MG 1 IN 1 DAY ORAL Albuterol (Salbutamol) C Depakote (Valproate Semisodium) C Date:07/29/04ISR Number: 4444068-5Report Type:Periodic Company Report #US-JNJFOC-20031203234 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Health Risperdal Initial or Prolonged Muscle Twitching Professional (Risperidone) Tablets PS ORAL 3 MG 2 IN 1 DAY ORAL Lamictal (Lamotrigine) C Celexa (Citalopram Hydrobromide) C 22-Feb-2006 08:20 AM Page: 2206 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4444069-7Report Type:Periodic Company Report #US-JNJFOC-20031201355 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Risperdal Non-Insulin-Dependent (Risperidone) Tablets PS ORAL 1.5 MG 2 IN 1 DAY ORAL Celebrex (Tablets) Celecoxib C Date:07/29/04ISR Number: 4444070-3Report Type:Periodic Company Report #US-JNJFOC-20031201377 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal White Blood Cell Count Professional (Risperidone) Increased Tablets PS ORAL 0.5 MG 1 IN 1 DAY ORAL Singulair (Montelukast Sodium) C Proventil (Salbutamol) C Fish Oil (Fish Oil) C Pulmicort (Budesonide) C Sinutab (Sinutab "Warner Chilcott") C Vitamins (Vitamins) C Zyrtec (Cetirizine Hydrochloride) C Xopenex (Levosalbutamol) C Date:07/29/04ISR Number: 4444071-5Report Type:Periodic Company Report #US-JNJFOC-20031202097 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Lacunar Infarction Health Risperdal Initial or Prolonged Professional (Risperidone) Company Tablets PS ORAL 3 MG 1 IN 1 Representative DAY ORAL Effexor (Venlafaxine Hydrochloride) C Date:07/29/04ISR Number: 4444072-7Report Type:Periodic Company Report #US-JNJFOC-20031202292 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Consumer Risperdal Initial or Prolonged (Risperidone) Tablet PS ORAL 2 MG 2 IN 1 DAY ORAL 22-Feb-2006 08:20 AM Page: 2207 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4444073-9Report Type:Periodic Company Report #US-JNJFOC-20030900217 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Health Risperdal Initial or Prolonged Insomnia Professional (Risperidone) Unspecified PS UNKNOWN UNKNOWN Date:07/29/04ISR Number: 4444074-0Report Type:Periodic Company Report #US-JNJFOC-20031202312 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Consumer Risperdal (Risperidone) Tablets PS ORAL ORAL Date:07/29/04ISR Number: 4444075-2Report Type:Periodic Company Report #US-JNJFOC-20040204957 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone) Company Unspecified PS ORAL ORAL Representative Date:07/29/04ISR Number: 4444076-4Report Type:Periodic Company Report #US-JNJFOC-20040204960 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone) Company Unspecified PS ORAL ORAL Representative Date:07/29/04ISR Number: 4444077-6Report Type:Periodic Company Report #US-JNJFOC-20030900220 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Professional (Risperidone) Unspecified PS ORAL 1 MG, 3 IN 1 DAY; ORAL Lexapro (All Other Therapeutic Products) SS ORAL 10 MG, 1 IN 1 DAY,ORAL Trileptal (Oxcarbazepine) SS ORAL 900 MG 1 IN 1 DAY; ORAL Oxcarbazepine C Date:07/29/04ISR Number: 4444078-8Report Type:Periodic Company Report #US-JNJFOC-20040204961 Age: Gender:Unknown I/FU:I Outcome PT Report Source Other Tardive Dyskinesia Health Professional 22-Feb-2006 08:20 AM Page: 2208 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Risperdal (Risperidone) Unspecified PS ORAL ORAL Date:07/29/04ISR Number: 4444079-XReport Type:Periodic Company Report #US-JNJFOC-20040203248 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Risperdal Initial or Prolonged Professional (Risperidone) Other Company Unspecified PS ORAL 4 MG, 1 IN 1 Representative DAY, ORAL Zyprexa (Olanzapine) C Xanax (Alprazolam) C Zoloft (Sertraline Hydrochloride) C Date:07/29/04ISR Number: 4444080-6Report Type:Periodic Company Report #US-JNJFOC-20030900409 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ascites Health Risperdal Oedema Peripheral Professional (Risperidone) Unspecified PS ORAL 3 MG, 1 IN 1 DAY; ORAL Date:07/29/04ISR Number: 4444081-8Report Type:Periodic Company Report #US-JNJFOC-20040203721 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Risperdal Initial or Prolonged Catatonia Professional (Risperidone) Drug Abuser Unspecified PS ORAL 4 MG, IN 1 Sedation DAY, ORAL Cannabis (Cannabis) SS Lorazepam (Lorazepam) SS 9 MG, IN 1 DAY; 3 MG, IN 1 DAY Divalproex (Valproate Semisodium) SS Date:07/29/04ISR Number: 4444082-XReport Type:Periodic Company Report #US-JNJFOC-20040104918 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Professional (Risperidone) Tablets PS ORAL 4 MG, IN 1 DAY, ORAL 22-Feb-2006 08:20 AM Page: 2209 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4444083-1Report Type:Periodic Company Report #US-JNJFOC-20030805799 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Consumer Risperdal (Risperidone) Tablets PS ORAL 2 MG, 2 IN 1 DAY; ORAL Depakote (Valproate Semisodium) C Atenolol C Date:07/29/04ISR Number: 4444084-3Report Type:Periodic Company Report #US-JNJFOC-20040100444 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Consumer Risperdal (Risperidone) Tablets PS ORAL 4 MG, 1 IN 1 DAY, ORAL; 0.5 MG, ORAL Phenobarbital (Phenobarbital) C Date:07/29/04ISR Number: 4444085-5Report Type:Periodic Company Report #US-JNJFOC-20031204947 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ageusia Consumer Risperdal Anxiety (Risperidone) Convulsion Tablets PS ORAL 1.5 MG, IN 1 Dizziness DAY, ORAL; Dyspnoea 0.5 MG, IN 1 Dystonia DAY, ORAL Headache Atendol (Tablets) Heart Rate Decreased Atenolol C Hypoaesthesia Torticollis Tremor Visual Acuity Reduced Date:07/29/04ISR Number: 4444087-9Report Type:Periodic Company Report #US-JNJFOC-20030806142 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Consumer Risperdal Initial or Prolonged Dysphagia Health (Risperidone) Other Hallucination, Auditory Professional Tablets PS ORAL 0.5 MG, 1 IN Musculoskeletal Stiffness 1 DAY; ORAL Paranoia (SEE IMAGE) Suicide Attempt Serzone (Nefazodone Tardive Dyskinesia Hydrochloride) C Tongue Paralysis Premarin (Estrogens Conjugated) C Lansoprazole C Zyprexa (Olanzapine) C Ativan (Lorazepam) C Zoloft (Sertraline Hydrochloride) C 22-Feb-2006 08:20 AM Page: 2210 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tagamet (Cimetidine) C Metoprolol C Prilosec (Omeprazole) C Date:07/29/04ISR Number: 4444089-2Report Type:Periodic Company Report #US-JNJFOC-20031200248 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, IN 1 DAY, ORAL Zyprexa (Olanzapine) C Date:07/29/04ISR Number: 4444090-9Report Type:Periodic Company Report #US-JNJFOC-20031200253 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Restlessness Consumer Risperdal Status Epilepticus (Risperidone) Tablets PS ORAL 3 MG, 1 IN 1 DAY, ORAL Calcium D (Calcium With Vitamin D) C Kepra (Levetiracetam) C Zonegran (Zonisamide) C Synthroid (Levothyroxine Sodium) C Allegra (Fexofenadine Hydrochloride) C Protonix (Pantoprazole) C Ativan (Lorazepam) C Advair Diskus (Seretide Mite) C Ketoconazole (Ketoconazole) C Desonide (Desonide) C Clobetasol (Clobetasol) C Date:07/29/04ISR Number: 4444092-2Report Type:Periodic Company Report #US-JNJFOC-20030805444 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal Initial or Prolonged Extrapyramidal Disorder Professional (Risperidone) Tablets PS ORAL 0.5 MG, 1 IN 1 DAY; ORAL Miacalain Nasal Spray (Calcitonin, Salmon) C Tylenol 22-Feb-2006 08:20 AM Page: 2211 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Acetaminophen/Codei ne) C Zoloft (Sertraline Hydrochloride) C Oyst Cal-D (Calcium Carbonate) C Pepcid (Famotidine) C Senna C Reminyl (Galantamine) Tablets C Colace (Ducusate Sodium) C Septra Ds (Bactrim) C Date:07/29/04ISR Number: 4444094-6Report Type:Periodic Company Report #US-JNJFOC-20030804617 Age:99 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Consumer Risperdal (Risperidone) Tablets PS ORAL ORAL Date:07/29/04ISR Number: 4444101-0Report Type:Periodic Company Report #US-JNJFOC-20030803878 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Risperdal Initial or Prolonged Professional (Risperidone) Unspecified PS ORAL 1 MG, 1 IN 1 DAY; ORAL Aldactone (Spironolactone) C Aricept (Donepezil Hydrochloride) C Date:07/29/04ISR Number: 4444102-2Report Type:Periodic Company Report #US-JNJFOC-20030804192 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Health Risperdal Initial or Prolonged Decreased Appetite Professional (Risperidone) Myalgia Tablets PS ORAL Nausea Rad001axd04 (All Vomiting Other Therapeutic Weight Decreased Products) SS 1.5 MG, 2 IN 1 DAY Neoral (Ciclosporin) C Prednisone C Minoxidil C Metoprolol C Procardia (Nifedipine) C Clonidine C Lasix (Furosemide) C Xanax (Alprazolam) C Protonix (Pantoprazole) C Reglan 22-Feb-2006 08:20 AM Page: 2212 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Metoclopramide) C Date:07/29/04ISR Number: 4444105-8Report Type:Periodic Company Report #US-JNJFOC-20030803681 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Consumer Risperdal Initial or Prolonged Hallucination, Auditory (Risperidone) Therapeutic Response Tablets PS ORAL 2 MG, 1 IN 1 Decreased DAY; ORAL Risperdal (Risperidone) Tablets SS ORAL 3 MG, 2 IN 1 DAY; ORAL Date:07/29/04ISR Number: 4444106-XReport Type:Periodic Company Report #US-JNJFOC-20031003261 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Non-Insulin-Dependent Professional (Risperidone) Company Tablets PS ORAL 3 MG, 1 IN 1 Representative DAY, ORAL Date:07/29/04ISR Number: 4444108-3Report Type:Periodic Company Report #US-JNJFOC-20031002428 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Consumer Risperdal Gait Disturbance (Risperidone) Hallucination, Auditory Tablets PS ORAL 0.5 MG, 2 IN Hallucination, Visual 1 DAY, ORAL Increased Appetite Aricept (Donepezil Insomnia Hydrochloride) C Transient Ischaemic Vitamin E Attack (Tocopherol) C Weight Increased Clonidine (Clonidine) C Paroxetine (Paroxetine) C Glyburide (Glibenclamide) C Alprazolam (Alprazolam) C Trazadone ( Trazadone) C Lisinopril (Lisinopril) C Asa (Acetylsalicylic Acid) C Simvastatin (Simvastatin) C Rabeprazole (Rabeprazole) C Donepezil (Donepezil) C 22-Feb-2006 08:20 AM Page: 2213 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4444110-1Report Type:Periodic Company Report #US-JNJFOC-20031002589 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Risperdal Insulin-Dependent Professional (Risperidone) PS ORAL ORAL Company Representative Date:07/29/04ISR Number: 4444111-3Report Type:Periodic Company Report #US-JNJFOC-20031002370 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Tremor Professional (Risperdione) Tablets PS ORAL 0.5 MG, 1 IN 1 DAY, ORAL Cogentin ( ) Benzatropine Mesilate C Date:07/29/04ISR Number: 4444114-9Report Type:Periodic Company Report #US-JNJFOC-20031002374 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Health Risperdal Initial or Prolonged Professional (Risperidone) Tablets PS ORAL 4 MG, 1 IN 1 DAY, ORAL Date:07/29/04ISR Number: 4444115-0Report Type:Periodic Company Report #US-JNJFOC-20031002377 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Consumer Risperdal Initial or Prolonged Asthma (Risperidone) Drug Withdrawal Syndrome Tablets PS ORAL 4 MG, 1 IN 24 Hypotension HOUR, ORAL Oedema Peripheral Risperdal (Risperidone) Tablets C Wellbutrin (Bupropion Hydrochloride) C Advair (Seretide Mite) C Albuterol (Salbutamol) C Lasix (Furosemide) C Levoxyl (Levothyroxine Sodium) C 22-Feb-2006 08:20 AM Page: 2214 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4444116-2Report Type:Periodic Company Report #US-JNJFOC-20031002037 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Consumer Risperdal (Risperidone) Tablets PS ORAL 0.5 MG, 2 IN 1 DAY, ORAL Depakote (Valproate Semisodium) C Date:07/29/04ISR Number: 4444118-6Report Type:Periodic Company Report #US-JNJFOC-20031001819 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Disorientation Professional (Risperidone) Loss Of Consciousness Tablets PS ORAL 2.5 MG, IN 1 DAY, ORAL Prozac (Fluoxetine Hydrochloride) C Date:07/29/04ISR Number: 4444123-XReport Type:Periodic Company Report #US-JNJFOC-20031000778 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Consumer Risperdal Initial or Prolonged Thrombosis (Risperidone) Unspecified PS ORAL 2.5 MG, ORAL Date:07/29/04ISR Number: 4444124-1Report Type:Periodic Company Report #US-JNJFOC-20031000777 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, 1 IN 1 DAY, ORAL Date:07/29/04ISR Number: 4448416-1Report Type:Periodic Company Report #US-JNJFOC-20040102566 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Consta Initial or Prolonged Extrapyramidal Disorder Professional (Risperidone) Schizophrenia Microspheres PS INTRAMUSCULAR 1 IN 2 WEEK, INTRA-MUSCULA R Date:07/29/04ISR Number: 4448418-5Report Type:Periodic Company Report #NSADSS2003024380 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Initial or Prolonged Laboratory Test Abnormal Professional (Risperidone) PS ORAL ORAL 22-Feb-2006 08:20 AM Page: 2215 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4448419-7Report Type:Periodic Company Report #NSADSS2003024902 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Consumer Risperdal Myocardial Infarction (Risperidone) Tablet PS ORAL S2 MG 2 IN 24 Transient Ischaemic HOUR ORAL Attack Thorazine (Chlorpromazine Hydrochloride) C Benztropine (Benzatropine Mesilate) C Nitroglycerin (Glyceryl Trinitrate) C Aciphex (Rabeprazole Sodium) C Monopril (Fosinopril Sodium) C Claritin (Loratadine) C Aspirin (Acetylsalicylic Acid) C Citalopram Hydrobromide (Citalopram Hydrobromide) C Clonazepam (Clonazepam) C Buspirone (Buspirone) C Date:07/29/04ISR Number: 4448420-3Report Type:Periodic Company Report #NSADSS2003024724 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Consumer Risperdal Initial or Prolonged Arthralgia (Risperidone) Chest Pain Unspecified PS ORAL SEE IMAGE Dyskinesia Haldol (Haloperidol) Dyspnoea Unspecified SS Haemorrhoids Detrol (Tolterodine Insomnia L-Tartrate) C Nasopharyngitis Ditropan Psychotic Disorder (Oxybutynin) C Swollen Tongue Cogentin Upper Respiratory Tract (Benzatropine Infection Mesilate) C Urinary Incontinence Inderal (Propranolol Hydrochloride) C Zyprexia (Olanzapine) C 22-Feb-2006 08:20 AM Page: 2216 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4448422-7Report Type:Periodic Company Report #NSADSS2003022695 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Consumer Risperdal (Risperidone) Unspecified PS UNKNOWN UNKNOWN Date:07/29/04ISR Number: 4448428-8Report Type:Periodic Company Report #NSADSS2003022721 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal Professional (Risperidone) Company Unspecified PS ORAL SEE IMAGE Representative Zoloft (Sertraline Hydrochloride) C Benadryl (Diphenhydramine Hydrochloride) C Desyrel (Trazodone Hydrochloride) C Atarax (Hydroxyzine Hydrochloride) C Date:07/29/04ISR Number: 4448429-XReport Type:Periodic Company Report #NSADSS2003023888 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal Professional (Risperidone) Unspecified PS ORAL 0.25 MG, 1 IN 1 DAY, ORAL Reminyl (Galantamine) C Lipitor (Atorvastatin) C Norvasc (Amlodipine Besilate) C Date:07/29/04ISR Number: 4448430-6Report Type:Periodic Company Report #NSADSS2003023975 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Risperdal Hypertensive Crisis Professional (Risperidone) Unspecified PS ORAL 0.25 MG, 1 IN 1 DAY, ORAL Depakote (Valproate Semisodium C Topamax (Topiramate) C Date:07/29/04ISR Number: 4448433-1Report Type:Periodic Company Report #NSADSS2003023983 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Other Dystonia Health Professional 22-Feb-2006 08:20 AM Page: 2217 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Risperdal (Risperidone) Tablet PS ORAL 0.25 MG, 1 IN 1 DAY, ORAL Trileptal (Oxcarbazepine) SS 75 MG, 2 IN 1 DAY Dextroamphetamine Sulfate (Dexamfetamine Sulfate) C Date:07/29/04ISR Number: 4448435-5Report Type:Periodic Company Report #NSADSS2003024110 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Hyperosmolar Health Risperdal Initial or Prolonged Coma Professional (Risperidone) Tablet PS ORAL SEE IMAGE Insulin (Insulin) C Depakote (Valproate Semisodium) C Wellbutrin (Bupropion Hydrochloride) C Lithium (Lithium) C Synthroid (Levothyroxine Sodium) C Cogentin (Benzatropine Mesilate) C Date:07/29/04ISR Number: 4448438-0Report Type:Periodic Company Report #US-JNJFOC-20040600299 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:07/29/04ISR Number: 4448441-0Report Type:Periodic Company Report #US-JNJFOC-20040504305 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal Consta Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R 22-Feb-2006 08:20 AM Page: 2218 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/04ISR Number: 4448443-4Report Type:Periodic Company Report #US-JNJFOC-20040502153 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:07/29/04ISR Number: 4448445-8Report Type:Periodic Company Report #US-JNJFOC-20040500610 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Consta Insomnia Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Depakote (Valproate Semisodium) C Valium (Diazepam) C Keppra (Levetiracetam) C Date:07/29/04ISR Number: 4448448-3Report Type:Periodic Company Report #US-JNJFOC-20040404500 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Health Risperdal Initial or Prolonged Professional (Risperidone) Tablets PS ORAL 2 MG, ORAL Risperdal Consta (Risperidone) Microspheres SS INTRAMUSCULAR INTRA-MUSCULA R Date:07/29/04ISR Number: 4448450-1Report Type:Periodic Company Report #US-JNJFOC-20040404320 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adverse Event Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Microspheres PS INTRAMUSCULAR INTRA-MUSCULA R Date:07/29/04ISR Number: 4448453-7Report Type:Periodic Company Report #US-JNJFOC-20040403293 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Consumer Risperdal Consta Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R 22-Feb-2006 08:20 AM Page: 2219 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lithium C Date:07/29/04ISR Number: 4448455-0Report Type:Periodic Company Report #US-JNJFOC-20040305467 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysarthria Consumer Risperdal Consta Dyskinesia (Risperidone) Gait Disturbance Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Somnolence WEEK, Tardive Dyskinesia INTRA-MUSCULA Weight Increased R Lexapro (All Other Therapeutic Products) C Clonazepam C Cogentin (Bnzatropine Mesilate) C Valium (Diazepam) C Zyrtec (Cetirizine Hydrochloride) C Prevacid (Lansoprazole) C Cephadyn (All Other Therapeutic Products) C Indocet (Indometacin) C Duragesic (Fentanyl) Patch C Albuterol (Salbutamol) C Milk Of Magnesia (Magnesium Hydroxide) C Seroquel (Quetiapine Fumarate) C Atrovent (Ipratropium Bromide) C Date:07/30/04ISR Number: 4415314-9Report Type:Expedited (15-DaCompany Report #L04-TUR-02577-01 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Diastolic Foreign Citalopram PS ORAL 1120 MG ONCE Initial or Prolonged Decreased Literature PO Depression Health Risperidone SS ORAL 160 MG ONCE Drug Interaction Professional PO Heart Rate Increased Other Paracetamol SS ORAL 1500 MG ONCE Intentional Overdose PO Multiple Drug Overdose Stupor Suicide Attempt 22-Feb-2006 08:20 AM Page: 2220 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/04ISR Number: 4415624-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040503812 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Health Risperdal Initial or Prolonged Dizziness Professional (Risperidone) PS Drug Abuser Company Dyspnoea Representative Date:07/30/04ISR Number: 4415626-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040606992 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Health Risperdal Initial or Prolonged Insulin-Dependent Professional (Risperidone) Sedation Tablets PS ORAL 0.5 MG , 2 IN 1 DAY, ORAL : 0.5 MG, 1 IN 1 DAY, ORAL Zoloft (Sertraline Hydrochloride) C Date:07/30/04ISR Number: 4415628-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040706422 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal Health (Risperidone) PS ORAL 1.5 MG, ORAL Professional Date:07/30/04ISR Number: 4415957-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040607188 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Foreign Risperdal Initial or Prolonged Health (Risperidone) PS ORAL 4 MG, 1 IN 1 Professional DAY, ORAL Promethazine Hydrochloride (Promethazine Hydrochloride) C Triazolam (Triazolam) C Lormetazepam (Lormetazepam) C Date:07/30/04ISR Number: 4415976-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040505714 Age:20 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pallor Foreign Risperdal Consta Pancreatitis Acute Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR SEE IMAGE Thyroxine (Levothyroxine Sodium) C 22-Feb-2006 08:20 AM Page: 2221 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/30/04ISR Number: 4415978-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040404518 Age:55 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Refusal Of Treatment By Foreign Risperdal Consta Initial or Prolonged Patient Health (Risperidone) Supraventricular Professional Microspheres PS INTRAMUSCULAR SEE IMAGE Tachycardia Thyroxine (Levothyroxine Sodium) C Date:07/30/04ISR Number: 4415980-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040606653 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Cancer Foreign Risperdal Consta Initial or Prolonged Galactorrhoea Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR INTRA-MUSCULA R Dipiperon (Pipamperone) Unspecified SS ORAL ORAL Urion (Alfuzosin Hydrochloride) C Date:07/30/04ISR Number: 4416115-8Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040501168 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Foreign Risperidone Initial or Prolonged Headache Health (Risperidone) Other Hypomania Professional Unspecified PS ORAL SEE IMAGE Intracranial Pressure Lithium Carbonate Increased (Lithium Carbonate) SS ORAL 1000 MG, IN 1 Optic Disc Disorder DAY, ORAL Papilloedema Amitriptyline C Retinal Haemorrhage Metformin Therapy Non-Responder (Metformin) C Date:07/30/04ISR Number: 4418087-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040607719 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Foreign Risperdal Initial or Prolonged Face Oedema Health (Risperidone) Hallucination Professional Tablets PS ORAL 0.5 MG, 2 IN Hypertonia 1 DAY, ORAL : Pyrexia 8 MG, IN 1 Somnolence DAY, ORAL : Urosepsis 16 MG, 1 IN 1 Reminyl (Galantamine) Tablets SS ORAL 4 MG, IN 1 DAY, ORAL : 40 MG, 1 IN 1 DAY Lasilix (Furosemide) C Aldactone (Spironolactone) C 22-Feb-2006 08:20 AM Page: 2222 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Kardegic (Acetylsalicylate Lysine) C Tahor (Atorvastatin Calcium) C Vastarel (Trimetazidine Hydrochloride) C Seropram (Citalopram Hydrobromide) C Equanil (Meprobamate) C Mopral (Omeprazole) C Date:08/02/04ISR Number: 4413236-0Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12654349 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Carbidopa + Levodopa Initial or Prolonged Epilepsy Cr PS Bristol-Myers Squibb Company ORAL 1.5 tablet Risperidone I ORAL Date:08/02/04ISR Number: 4415989-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040707589 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Foreign Risperdal Consta Mutism Health (Risperidone) Professional Microspheres PS Company Representative Date:08/02/04ISR Number: 4416444-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040606158 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Foreign Risperdal Disease Recurrence Health (Risperidone) Leukopenia Professional Tablets PS ORAL 2 MG, IN 1 Neutropenia DAY, ORAL Date:08/02/04ISR Number: 4416447-3Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040706707 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Foreign Risperdal Increased Health (Risperidone) PS ORAL 6 MG, IN 1 Blood Glucose Increased Professional DAY, ORAL Blood Triglycerides Zyprexa (Olanzapine) C ORAL 30 MG, IN 1 Increased DAY, ORAL Polydipsia Sertraline Polyuria (Sertraline) C Temazepam (Temazepam) C Clonazepam (Clonazepam) C 22-Feb-2006 08:20 AM Page: 2223 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trazodone (Trazodone) C Date:08/03/04ISR Number: 4414037-XReport Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0327083A Age:49 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Paxil PS Glaxosmithkline ORAL 20MG Per day 12 DAY Depressed Mood Risperdal SS ORAL Hyperhidrosis Limas C Glaxosmithkline ORAL Insomnia Silece C ORAL 2MG Per day Muscle Rigidity Lendormin C ORAL .25MG Per day Serotonin Syndrome Tremor Date:08/03/04ISR Number: 4417632-7Report Type:Expedited (15-DaCompany Report #L04-TUR-02577-01 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Diastolic Foreign Citalopram PS ORAL 1120 MG ONCE Initial or Prolonged Decreased Literature PO Depression Health Risperidone SS ORAL 160 MG ONCE Drug Interaction Professional PO Feeling Guilty Other Paracetamol SS ORAL 1500 MG ONCE Heart Rate Increased PO Intentional Overdose Stupor Suicide Attempt Date:08/03/04ISR Number: 4417733-3Report Type:Expedited (15-DaCompany Report #2004031828 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Sortis Initial or Prolonged Circadian Rhythm Sleep Health (Atorvastatin) PS ORAL 20 MG (20 MG, Disorder Professional 1 IN 1 D), Confusional State Company ORAL Faecal Incontinence Representative Carvedilol Mental Disorder (Carvedilol) SS ORAL 50 MG (25 MG, Myalgia 2 IN 1 D), Nervous System Disorder ORAL Restlessness Risperidone Sleep Disorder (Risperidone) SS ORAL 1 MG (1 MG, 1 Urinary Incontinence IN 1 D), ORAL Candesartan Cilexetil (Candesartan Cilexetil) SS ORAL 16 MG (8 MG, 2 IN 1 D), ORAL Molsidomine (Molsidomine) SS ORAL 8 MG (8 MG, 1 IN 1 D), ORAL Zopiclone (Zopiclone) SS ORAL 7.5 MG (7.5 MG), ORAL Isosorbide Dinitrate (Isosorbide 22-Feb-2006 08:20 AM Page: 2224 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dinitrate) C Moxonidine (Moxonidine) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Insulin Human Injection, Isophane (Insulin Human Injection, Isophane) C Pipamperone (Pipamperone) C Diazepam (Diazepam) C Metamizole Sodium (Metamizole Sodium) C Date:08/03/04ISR Number: 4417739-4Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20040602074 Age:7 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Risperdal Initial or Prolonged Fatigue Health (Risperidone) Medication Error Professional Solution PS ORAL 0.4 MG ORAL Miosis Date:08/04/04ISR Number: 4414936-9Report Type:Expedited (15-DaCompany Report #ES-BRISTOL-MYERS SQUIBB COMPANY-12650974 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocarditis Health Modecate Inj 25 Professional Mg/Ml PS Apothecon INTRAMUSCULAR 1 DAY Akineton SS INTRAMUSCULAR Trileptal SS ORAL 1 DAY Risperdal SS ORAL 1 DAY Date:08/04/04ISR Number: 4416028-1Report Type:Direct Company Report #CTU 224187 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Risperdal PS Intervention to Dystonia Geodon SS Prevent Permanent Tenex C Impairment/Damage Zoloft C Concerta C Date:08/04/04ISR Number: 4416029-3Report Type:Direct Company Report #CTU 224190 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blepharospasm Risperidone 1 Mg Required Tablets (Janssen) PS Janssen ONE BID Intervention to Geodon C Prevent Permanent Impairment/Damage 22-Feb-2006 08:20 AM Page: 2225 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/05/04ISR Number: 4423257-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040707652 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Risperdal Professional (Risperidone) Tablets PS ORAL 2 MG, 1 IN 1 DAY, ORAL Date:08/05/04ISR Number: 4423258-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040707301 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Consumer Risperdal (Risperidone) Tablets PS ORAL 1 MG, 1 IN 1 DAY, ORAL Date:08/05/04ISR Number: 4423602-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040405795 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Foreign Risperdal Initial or Prolonged Positive Health (Risperidone) Eczema Professional Tablets PS ORAL 0.25 MG, IN 1 Leukocytoclastic DAY, ORAL : Vasculitis 0.5 MG, IN 1 Vascular Purpura DAY, ORAL Vasculitis Necrotising Previscan (Fluindione) C Coversyl (Perindopril) C Amlor (Amlodipine Besilate) C Lasilix (Furosemide) C Clopixol (Zuclopenthixol Decanoate) C Daflon (Diosmin) C Diafusor (Glyceryl Trinitrate) C Date:08/06/04ISR Number: 4421841-0Report Type:Expedited (15-DaCompany Report #2004UW16187 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Study Risperidone PS ORAL 4 MG DAILY PO Initial or Prolonged Anxiety Health Wellbutrin C Gas Poisoning Professional Ibuprofen C Psychotic Disorder Date:08/06/04ISR Number: 4421842-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040708058 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal Consta Initial or Prolonged (Risperidone) Microspheres PS ORAL 25 MG, 1 IN 22-Feb-2006 08:20 AM Page: 2226 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 2 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Tablets SS ORAL 5 MG, IN 1 DAY, ORAL Synthroid (Levothyroxine Sodium) Tablets C Date:08/06/04ISR Number: 4422477-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040707368 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Consumer Risperdal (Risperidone) Tablets PS ORAL 10 MG, 2 IN 1 DAY, ORAL Stelazine (Trifluoperazine Hydrochloride) Tablets C Date:08/06/04ISR Number: 4422481-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040708079 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Unspecified PS Date:08/06/04ISR Number: 4422920-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040800057 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Professional (Risperidone) Tablets PS ORAL 3 MG, ORAL Date:08/06/04ISR Number: 4422921-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040800547 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Consumer Risperdal (Risperidone) Tablets PS ORAL 3 MG, ORAL Zyrtec (Cetirizine Hydrochloride) C Topamax (Top0iramate) C Effexor (Venlafaxine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 2227 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/04ISR Number: 4422922-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040800557 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Candiduria Health Risperdal Cardiac Arrest Professional (Risperidone) Drug Interaction Tablets PS ORAL 2 MG, 1 IN 1 Metabolic Encephalopathy DAY, ORAL Neutropenia Paxil (Paroxetine Pancytopenia Hydrochloride) C Platelet Count Decreased Pseudomonas Infection Respiratory Failure Sepsis Sputum Culture Positive White Blood Cell Count Decreased Date:08/06/04ISR Number: 4423059-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040506140 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperprolactinaemia Foreign Risperdal Initial or Prolonged Metrorrhagia Health (Risperidone) PS ORAL SEE IMAGE Ovarian Neoplasm Professional Biperiden Parkinson'S Disease Hydrochloride (Biperiden Hydrochloride) C Bromocriptine Mesylate (Bromocriptine) C Brotizolam (Brotizolam) C Ethyl Loflazepate (Ethyl Loflazepate) C Diazepam (Diazepam) C Chlorromazine Hydrochloride (Chlorpromazine Hydrochloride) C Date:08/06/04ISR Number: 4423061-2Report Type:Expedited (15-DaCompany Report #MX-JNJFOC-20040800094 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Risperdal Initial or Prolonged Extrapyramidal Disorder Health (Risperidone) PS ORAL 1 MG, 1 IN 1 Gastrointestinal Injury Professional DAY, ORAL Granulocyte Count Akineton (Biperiden Decreased Hydrochloride) C Oesophageal Injury Olanzapine Platelet Count Decreased (Olanzapine) C White Blood Cell Count Decreased 22-Feb-2006 08:20 AM Page: 2228 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/04ISR Number: 4423357-4Report Type:Expedited (15-DaCompany Report #FLUV00304002536 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Foreign Luvox 25 Initial or Prolonged Syndrome Health (Fluvoxamine Professional Maleate) PS ORAL 225 MG DAILY Other PO Anafranil (Clomipramine Hydrochloride) SS ORAL 150 MG DAILY PO Risperdal Risperidone) SS ORAL 4 NG DAILY PO Myslee Zolpidem Tartrate) C Rohypnol (Flunitrazepam) C Depas (Etizolam) C Akineton (Biperiden Hydrochloride) C Daonil (Glibenclamide) C Basen (Voglibose) C Wintermin (Chlorpromazine Hydrochloride) C Date:08/06/04ISR Number: 4423385-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040607719 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Risperdal Initial or Prolonged Anxiety Health (Risperidone) Bacterial Infection Professional Tablets PS ORAL 0.5 MG 2 IN 1 Face Oedema DAY ORAL Hallucination Reminyl Hypertonia (Galantamine) Somnolence Tablets SS ORAL 4 MG IN 1 DAY Urinary Tract Infection ORAL Urosepsis Lasilix (Furosemide) C Aldactone (Spironolactone) C Kardegic (Acetylsalicylate Lysine) C Tahor (Atorvastatin Calcium) C Vastarel (Trimetazidine Hydrochloride) C Seropram (Citalopram Hydrobromide) C Equanil (Meprobamate) Tablets C Mopral (Omeprazole) C 22-Feb-2006 08:20 AM Page: 2229 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/04ISR Number: 4424816-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040602740 Age:77 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Risperdal Initial or Prolonged Atrial Fibrillation Health (Riperidone) PS ORAL 4 MG, 2 IN 1 Bradycardia Professional DAY, ORAL Circulatory Collapse Company Shock Representative Tricuspid Valve Incompetence Ventricular Extrasystoles Ventricular Hypertrophy Date:08/09/04ISR Number: 4424817-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040607731 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amenorrhoea Foreign Risperdal Initial or Prolonged Blood Prolactin Increased Health (Risperidone) Breast Tenderness Professional Solution PS ORAL 4 MG, 2 IN 1 Galactorrhoea Company DAY, ORAL Pituitary Tumour Benign Representative Deroxat (Aproxetine Weight Increased Hydrochloride) C Date:08/09/04ISR Number: 4424977-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040800050 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Health Risperdal Professional (Risperidone) Company Tablets PS ORAL 5 MG, IN 1 Representative DAY, ORAL Date:08/10/04ISR Number: 4422236-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031004738 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amniocentesis Abnormal Risperdal PS OROPHARINGEAL Initial or Prolonged Condition Aggravated Haldol SS OROPHARINGEAL Delusion Depakote C Drug Exposure During Imovane C Pregnancy Speciafoldine C Pregnancy Xenetix C Pulmonary Embolism Date:08/11/04ISR Number: 4422900-9Report Type:Expedited (15-DaCompany Report #IL-JNJFOC-20040801521 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Risperdal PS UNKNOWN 22-Feb-2006 08:20 AM Page: 2230 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/04ISR Number: 4423038-7Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20040708048 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aortic Atherosclerosis Risperdal PS OROPHARINGEAL Facial Palsy Efexor C OROPHARINGEAL Nuclear Magnetic Temesta C OROPHARINGEAL Resonance Imaging Abnormal Date:08/11/04ISR Number: 4423039-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040601726 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Risperdal PS OROPHARINGEAL Increased Semisodium Valproate C Blood Bilirubin Increased Omega 3 C Blood Pressure Increased Thyroxine C Confusional State Ketoconazole C 1-2 weekly Disorientation Oxytetracycline C Transient Ischaemic Procyclidine C Attack Date:08/11/04ISR Number: 4424994-3Report Type:Direct Company Report #CTU 224769 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coagulopathy Abilify PS 5 MG DAILY Multi-Organ Failure Risperidone SS 3 MG DAILY Neuroleptic Malignant Syndrome Rhabdomyolysis Date:08/12/04ISR Number: 4424390-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040800515 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Risperdal PS OROPHARINGEAL Initial or Prolonged Fall Professional Tiapridal SS OROPHARINGEAL 20 drops Other Overdose Aricept C Stilnox C Zoloft C Cacit Vitamine D3 C Cacit Vitamine D3 C Date:08/12/04ISR Number: 4424391-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040800807 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal PS OROPHARINGEAL Decreased 22-Feb-2006 08:20 AM Page: 2231 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/04ISR Number: 4424392-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040801437 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:08/12/04ISR Number: 4424393-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040801550 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal PS OROPHARINGEAL Date:08/12/04ISR Number: 4424394-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040801640 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Risperdal PS OROPHARINGEAL Sudden Death Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Paracetamol C UNKNOWN Diprobase C UNKNOWN Diprobase C UNKNOWN Diprobase C UNKNOWN Diprobase C UNKNOWN Date:08/12/04ISR Number: 4424395-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040801819 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:08/12/04ISR Number: 4424396-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040801888 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:08/12/04ISR Number: 4424397-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040801985 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Risperdal Consta PS INTRAMUSCULAR Weight Increased Zoloft C UNKNOWN Date:08/12/04ISR Number: 4424398-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040802066 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 2232 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/04ISR Number: 4424399-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040603102 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arthritis Risperdal PS OROPHARINGEAL 0.125mg in Serum Sickness am/0.25mg at HS 3 MON Risperdal SS OROPHARINGEAL 3 MON Concerta SS Clonidine C Clonidine C Zyrtec C OROPHARINGEAL 27 DAY Pepcid C Nasonex C RESPIRATORY (INHALATION) 50mcg 27 DAY Flovent C RESPIRATORY (INHALATION) 2 puffs as needed 27 DAY Date:08/12/04ISR Number: 4424400-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040705349 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS OROPHARINGEAL Professional Date:08/12/04ISR Number: 4424401-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040802579 Age:97 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL 5 YR Date:08/12/04ISR Number: 4424402-2Report Type:Expedited (15-DaCompany Report #EMADSS2002006993 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Thrombocytopenia Health Risperdal PS OROPHARINGEAL 189 DAY Initial or Prolonged Professional Risperdal SS OROPHARINGEAL 189 DAY Risperdal SS OROPHARINGEAL 189 DAY Ximovan C OROPHARINGEAL 167 DAY Pantozol C OROPHARINGEAL Allopurinol C OROPHARINGEAL Allopurinol C OROPHARINGEAL Folsan C OROPHARINGEAL 168 DAY Folsan C OROPHARINGEAL 168 DAY Date:08/12/04ISR Number: 4424403-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040604502 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Health Risperdal PS OROPHARINGEAL start date Professional approximate Stelazine C UNKNOWN 22-Feb-2006 08:20 AM Page: 2233 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/04ISR Number: 4424404-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040205524 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Risperdal PS OROPHARINGEAL Initial or Prolonged Depressed Level Of Professional Triatec C OROPHARINGEAL Other Consciousness Levothyroxine C Drug Interaction Topalgic I OROPHARINGEAL 12 DAY Epilepsy Aricept I OROPHARINGEAL Intestinal Obstruction Paresis Tremor Date:08/12/04ISR Number: 4424405-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040505714 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bacteria Sputum Health Risperdal Consta PS INTRAMUSCULAR Identified Professional Risperdal Consta SS INTRAMUSCULAR Bacteria Tissue Specimen Thyroxine C Identified Fat Necrosis Gastritis Gynaecomastia Headache Male Pattern Baldness Oral Mucosal Disorder Pancreatitis Acute Pancreatitis Necrotising Pulmonary Congestion Pulmonary Haemorrhage Pulmonary Oedema Scrotal Swelling Date:08/12/04ISR Number: 4424406-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040506536 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pyrexia Health Risperdal PS OROPHARINGEAL Respiratory Arrest Professional Sevredol C Athymil C Lexomil C Noctran C Noctran C Noctran C Glucophage C Diamicron C Cozaar C Loxen C Dafalgan C Sulfarlem C Nifluril C Kardegic C Rhinofluimucil C NASAL Rhinofluimucil C NASAL Rhinofluimucil C NASAL Cold Cream Naturel C Cold Cream Naturel C Cold Cream Naturel C Cold Cream Naturel C 22-Feb-2006 08:20 AM Page: 2234 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/04ISR Number: 4424407-1Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040706707 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Health Risperdal PS OROPHARINGEAL 48 MON Increased Professional Zyprexa SS OROPHARINGEAL 11 MON Blood Glucose Increased Sertraline C OROPHARINGEAL Blood Triglycerides Temazepam C dose taken at Increased night Polydipsia Clonazepam C dose taken at Polyuria night Trazodone C dose taken at night Date:08/12/04ISR Number: 4424408-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040802991 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Haemorrhage Risperdal PS OROPHARINGEAL 4 DAY Haloperidol C OTHER Date:08/12/04ISR Number: 4424409-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040701323 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Medication Error Health Risperdal PS OROPHARINGEAL Parkinsonism Professional Date:08/12/04ISR Number: 4424432-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040607996 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Risperdal PS 4 YR Initial or Prolonged Drug Effect Decreased Risperdal SS 4 YR Photosensitivity Reaction Risperdal SS 4 YR Fluoride C Paracetamol C Date:08/12/04ISR Number: 4424433-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040601724 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Risperdal PS OROPHARINGEAL Increased Risperdal SS OROPHARINGEAL Haemoglobin Decreased Risperdal SS OROPHARINGEAL Platelet Count Increased Risperdal SS OROPHARINGEAL Protein Total Decreased Risperdal SS OROPHARINGEAL Red Blood Cell Count Risperdal SS OROPHARINGEAL Decreased Risperdal SS OROPHARINGEAL Tremor Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Levomepromazine Maleate C OROPHARINGEAL Levomepromazine Maleate C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2235 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levomepromazine Maleate C OROPHARINGEAL Levomepromazine Maleate C OROPHARINGEAL Levomepromazine Maleate C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Clonazepam C OROPHARINGEAL Quetiapine C Quetiapine C Quetiapine C Quetiapine C Quetiapine C Quetiapine C Haloperidol C INTRAMUSCULAR Amobarbital C OROPHARINGEAL Bromvalerylurea C OROPHARINGEAL Olanzapine C OROPHARINGEAL Date:08/13/04ISR Number: 4425142-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040801529 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Clozaril PS OROPHARINGEAL Stress Trazodone C UNKNOWN Tachycardia Procyclidine C UNKNOWN Risperdal I OROPHARINGEAL Date:08/13/04ISR Number: 4425143-8Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040801953 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Arrhythmia Neonatal Initial or Prolonged Drug Exposure During Pregnancy Foetal Heart Rate Abnormal Neonatal Disorder 22-Feb-2006 08:20 AM Page: 2236 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Distress Resuscitation Report Source Product Role Manufacturer Route Dose Duration Risperdal Consta PS Ventolin C INTRA-UTERINE Seretide C INTRA-UTERINE Seretide C INTRA-UTERINE Efexor C INTRA-UTERINE 1 x 150 (units unspecified) once daily Panadeine C INTRA-UTERINE Panadeine C INTRA-UTERINE Frequency: "Stat" Pethidine C INTRA-UTERINE Frequency: "stat" Maxalon C INTRA-UTERINE Frequency: "stat" Benzodiazepine C INTRA-UTERINE Methamphetamine C INTRA-UTERINE Mother uses methamphetami ne daily: 0.6-0.8g per day. Date:08/13/04ISR Number: 4425144-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040801974 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sedation Risperdal PS OROPHARINGEAL Tachyarrhythmia Transient Ischaemic Attack Ventricular Tachycardia Date:08/13/04ISR Number: 4425145-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040602726 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Risperdal PS OROPHARINGEAL Initial or Prolonged Confusional State Risperdal SS OROPHARINGEAL Disability Faecal Incontinence Risperdal SS OROPHARINGEAL Other Feeling Drunk Risperdal SS OROPHARINGEAL Hallucination, Visual Incoherent Muscle Rigidity Retinal Scar Urinary Incontinence Verbal Abuse Visual Disturbance Weight Increased Date:08/13/04ISR Number: 4425146-3Report Type:Periodic Company Report #US-JNJFOC-20040505807 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Exposure During Risperdal PS OROPHARINGEAL Pregnancy Risperdal SS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2237 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Zoloft C OROPHARINGEAL Date:08/13/04ISR Number: 4425147-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040803674 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Risperdal SS OROPHARINGEAL Zoloft C OROPHARINGEAL Trazodone C OROPHARINGEAL Date:08/13/04ISR Number: 4425148-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040707589 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Risperdal Consta PS Mutism Date:08/13/04ISR Number: 4425149-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040703599 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Atrophy Risperdal PS OROPHARINGEAL Cerebrovascular Accident Infarction Metabolic Encephalopathy Date:08/13/04ISR Number: 4425150-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040500652 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Influenza Like Illness Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Nausea Sickle Cell Anaemia Date:08/16/04ISR Number: 4426745-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040801994 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinson'S Disease Risperdal PS UNKNOWN Date:08/16/04ISR Number: 4426746-7Report Type:Expedited (15-DaCompany Report #NSADSS2003024184 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Interaction Health Procrit PS 8 DAY Initial or Prolonged Convulsion Professional Celexa SS UNKNOWN Haemoglobin Decreased Risperdal SS UNKNOWN Combivir C Combivir C Kaletra C Kaletra C 22-Feb-2006 08:20 AM Page: 2238 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/16/04ISR Number: 4426747-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040803919 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:08/16/04ISR Number: 4426748-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040803931 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Health Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Homicidal Ideation Professional Alcohol SS Suicidal Ideation Risperdal C 2 mg in the am and 4 mg in pm Date:08/16/04ISR Number: 4426749-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040103161 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS OROPHARINGEAL Professional Date:08/16/04ISR Number: 4429467-XReport Type:Expedited (15-DaCompany Report #04P-144-0268818-00 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Foreign Akineton (Biperiden) Myocarditis Health (Biperiden) PS INTRAMUSCULAR 2.5 MG, 1 IN Pyrexia Professional 1 D, INTRAMUSCULAR Modecate SS INTRAMUSCULAR 12 MG, 1 IN 1 D, INTRAMUSCULAR Trileptal SS ORAL 600 MG, 1 IN 1 D, PER ORAL Risperidone SS ORAL 2 MG, 1 IN 1 D, PER ORAL Date:08/17/04ISR Number: 4427469-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040803902 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Subdural Haematoma Risperdal PS OROPHARINGEAL Other Seroquel C Date:08/17/04ISR Number: 4427646-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040803455 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Risperdal PS OROPHARINGEAL Initial or Prolonged Haloperidol C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Brotizolam C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2239 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/17/04ISR Number: 4431063-5Report Type:Expedited (15-DaCompany Report #2004PK01352 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cerebellar Infarction Foreign Seroquel PS ORAL 300 MG DAILY Hypertension Health PO Pulmonary Embolism Professional Cipramil SS 30 MG DAILY Thrombocythaemia Other Risperdal SS 4 MG DAILY Remergil SS 45 MG DAILY Date:08/18/04ISR Number: 4428789-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040607188 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Health Risperdal PS OROPHARINGEAL 25 DAY Initial or Prolonged Dermatitis Exfoliative Professional Haloperidol SS OROPHARINGEAL Drug Interaction Haloperidol SS OROPHARINGEAL Parkinson'S Disease Haloperidol SS OROPHARINGEAL In Apr-2004 Pemphigoid the dose of Thrombocytopenia haloperidol was increased. Haloperidol SS OROPHARINGEAL On 23-JAN-04 oral admin of haloperidol was initiated. Prednisolone SS OROPHARINGEAL 169 DAY Promethazine Hydrochloride C OROPHARINGEAL Triazolam C OROPHARINGEAL Lormetazepam C OROPHARINGEAL Date:08/18/04ISR Number: 4428790-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040303292 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Risperdal Consta PS INTRAMUSCULAR Bronchitis Sudden Death Date:08/18/04ISR Number: 4428791-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040305726 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Toxic Epidermal Health Risperdal PS OROPHARINGEAL Necrolysis Professional Psychotropic Agents C OROPHARINGEAL Vegetamin C UNKNOWN Vegetamin C UNKNOWN Vegetamin C UNKNOWN Date:08/18/04ISR Number: 4428792-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040701117 Age: Gender:Female I/FU:I Outcome PT Other Anxiety Erythropenia Haematocrit Decreased 22-Feb-2006 08:20 AM Page: 2240 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemoglobin Decreased Report Source Product Role Manufacturer Route Dose Duration Health Risperdal PS OROPHARINGEAL Professional Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL Chlorpromazine Tannate C OROPHARINGEAL Flunitrazepam C OROPHARINGEAL Aldioxa C OROPHARINGEAL Stomachics And Digestives C OROPHARINGEAL Stomachics And Digestives C OROPHARINGEAL Stomachics And Digestives C OROPHARINGEAL Stomachics And Digestives C OROPHARINGEAL Sennoside C OROPHARINGEAL Sodium Picosulfate C OROPHARINGEAL Date:08/18/04ISR Number: 4428793-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040708058 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Cognitive Disorder Risperdal SS OROPHARINGEAL Hallucination, Auditory Risperdal SS OROPHARINGEAL 2 mg in am 3 Memory Impairment mg in pm Synthroid C OROPHARINGEAL Date:08/18/04ISR Number: 4428794-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040703685 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alcohol Use Risperdal PS OROPHARINGEAL Blood Amylase Increased Lexapro C Lipase Increased Lexapro C Seroquel C Seroquel C Vistaril C Biaxin C Amoxicillin C Prevacid C Date:08/18/04ISR Number: 4428795-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040602345 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Health Risperdal PS OROPHARINGEAL 85 DAY Professional Ativan C Ativan C Ativan C Paxil C Paroxetine Hcl C Pentoxifylline C Oxybutynin Chloride C 22-Feb-2006 08:20 AM Page: 2241 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Humulin N 100 C Levoxyl C Flonase C Lisinopril C Date:08/18/04ISR Number: 4429352-3Report Type:Direct Company Report #CTU 225218 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Risperidone 2mg PS ORAL 2MG BID ORAL Date:08/18/04ISR Number: 4429410-3Report Type:Direct Company Report #CTU 225240 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cogwheel Rigidity Ziprosidone Hcl 80 Nystagmus Mg Po Bid PS ORAL PO BID Tremor Risperidone 3 Mg Po Hs SS ORAL PO HS Date:08/18/04ISR Number: 4430632-6Report Type:Expedited (15-DaCompany Report #04P-062-0269005-00 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Drug Overdose Foreign Akineton (Biperiden) Initial or Prolonged Intentional Health (Biperiden) PS ORAL ONCE, PER Suicide Attempt Professional ORAL Lorazepam SS ORAL 12-16 TABLETS, ONCE, PER ORAL Risperidone SS ORAL ONCE, PER ORAL Flunitrazepam SS ORAL ONCE, PER ORAL Clopenthixol Hydrochloride SS ORAL ONCE, PER ORAL Date:08/18/04ISR Number: 4431134-3Report Type:Expedited (15-DaCompany Report #FLUV00304002536 Age:39 YR Gender:Male I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Albumin Globulin Ratio Abnormal Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Chloride Decreased Blood Creatine Phosphokinase Increased Blood Lactate 22-Feb-2006 08:20 AM Page: 2242 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dehydrogenase Increased Blood Potassium Decreased C-Reactive Protein Increased Report Source Product Role Manufacturer Route Dose Duration Cold Sweat Foreign Luvox 25 Erythema Health (Fluvoxamine Haematocrit Decreased Professional Maleate) PS ORAL 75 MG DAILY Heart Rate Increased Other PO, 225 MG Hyperventilation DAILY PO Hypoaesthesia Risperdal Neuroleptic Malignant (Risperidone) SS ORAL 4 MG DAILY PO Syndrome Wintermin Palpitations (Chlorpromazine Platelet Count Decreased Hydrochloride) SS ORAL 12.5 MG DAILY White Blood Cell Count PO Increased Anafranil (Clomipramine Hydrochloride) C ORAL 105 MG DAILY PO, 150 MG DAILY PO Myslee (Zolpidem Tartrate) C Rohypnol (Flunitrazepam) C Depas (Etizolam) C Akineton (Diperiden Hydrochloride) C Daonil (Glibenclamide) C Basen (Voglibose) C Date:08/19/04ISR Number: 4429357-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040700484 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenopia Risperdal PS OROPHARINGEAL 8 DAY Initial or Prolonged Brain Stem Haemorrhage Lorazepam C OROPHARINGEAL Disability Dizziness Hemiplegia Insomnia Musculoskeletal Stiffness Date:08/19/04ISR Number: 4429358-4Report Type:Expedited (15-DaCompany Report #IL-JNJFOC-20040801521 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Risperdal PS UNKNOWN Pulmonary Embolism Risperdal SS UNKNOWN Artan SS Norvasc C Propranol C Date:08/19/04ISR Number: 4430691-0Report Type:Direct Company Report #CTU 225329 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Resperidone 1 Mg Od Syncope Tablet Kali Laboratoriesm Inc PS Kali Laboratoriesm 22-Feb-2006 08:20 AM Page: 2243 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Inc ORAL ONE (1) TABLET ORALLY Date:08/20/04ISR Number: 4429863-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040303693 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrioventricular Block Health Risperdal PS OROPHARINGEAL 3 DAY Second Degree Professional Risperdal SS OROPHARINGEAL 3 DAY Balance Disorder Risperdal Consta SS INTRAMUSCULAR Bradycardia Deroxat C Drug Interaction Lysanxia C Hypotension Duphalac C Hypothermia Incoherent Lung Infection Overdose Pancytopenia Septic Shock Speech Disorder Staphylococcal Sepsis Ventricular Extrasystoles Date:08/20/04ISR Number: 4429864-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040701117 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Health Risperdal PS OROPHARINGEAL Erythropenia Professional Lorazepam C OROPHARINGEAL Haematocrit Decreased Lorazepam C OROPHARINGEAL Haemoglobin Decreased Lorazepam C OROPHARINGEAL Chlorpromazine Tannate C OROPHARINGEAL Flunitrazepam C OROPHARINGEAL Aldioxa C OROPHARINGEAL Stomachics And Digestives C OROPHARINGEAL Stomachics And Digestives C OROPHARINGEAL Stomachics And Digestives C OROPHARINGEAL Stomachics And Digestives C OROPHARINGEAL Sennoside C OROPHARINGEAL Sodium Picosulfate C OROPHARINGEAL Date:08/20/04ISR Number: 4430215-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040804627 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal Consta PS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Olanzapine SS OROPHARINGEAL Lithium C OROPHARINGEAL Fluoxetine C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2244 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/04ISR Number: 4430216-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040607460 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Health Risperdal PS OROPHARINGEAL Initial or Prolonged Delirium Professional Leponex SS OROPHARINGEAL Other Depressed Level Of Consciousness Disorientation Drug Level Below Therapeutic Grand Mal Convulsion Hyponatraemia Renal Failure Acute Rhabdomyolysis Treatment Noncompliance Urinary Incontinence Date:08/20/04ISR Number: 4431368-8Report Type:Direct Company Report #CTU 225355 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tremor Risperdal 1 Mg /Ml Janssen PS Janssen ORAL 1 MG QD ORAL Date:08/23/04ISR Number: 4431212-9Report Type:Direct Company Report #CTU 225420 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Risperdal 2 Milligrams PS ORAL 2 MILLIG QHS ORAL Remeron C Effexor Xr C Aspirin C Colace C Ect C Date:08/23/04ISR Number: 4433163-2Report Type:Expedited (15-DaCompany Report #2004054836 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Consumer Neurontin Condition Aggravated (Gabapentin) PS Fatigue Geodon (Ziprasidone Pain In Jaw Hydrochloride) Sexual Dysfunction (Ziprasidone) SS 40 MG Somnolence Risperidone Vision Blurred (Risperidone) SS Paracetamol (Paracetamol) SS Olanzapine (Olanzapine) SS Aripiprazole (Aripiprazole) SS 22-Feb-2006 08:20 AM Page: 2245 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/24/04ISR Number: 4431199-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040803509 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Risperdal PS OROPHARINGEAL Initial or Prolonged Extrapyramidal Disorder Risperdal SS OROPHARINGEAL Fall Imovane C UNKNOWN Orthostatic Hypotension Rythmol C UNKNOWN Rhabdomyolysis Levothyrox C UNKNOWN Date:08/24/04ISR Number: 4431200-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040706519 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Health Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Asthenia Professional Risperdal SS OROPHARINGEAL Feeling Drunk Risperdal SS OROPHARINGEAL Hypotonia Tercian C OROPHARINGEAL Sedation Tercian C OROPHARINGEAL Speech Disorder Imovane C Artane C Thiamine C Vitamin B1 C Vitamin B6 C Date:08/24/04ISR Number: 4431201-4Report Type:Periodic Company Report #AU-JNJFOC-20040801953 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Risperdal Consta PS Initial or Prolonged Arrhythmia Risperidone SS INTRA-UTERINE Respiratory Distress Risperidone SS INTRA-UTERINE Umbilical Cord Around Ventolin C INTRA-UTERINE Neck Seretide C INTRA-UTERINE Seretide C INTRA-UTERINE Efexor C INTRA-UTERINE 1 x 150 (units unspecified) once daily Panadeine C INTRA-UTERINE 2 x 500 mg tablets as required Panadeine C INTRA-UTERINE Frequency: "Stat" Pethidine C INTRA-UTERINE Frequency: "stat" Maxalon C INTRA-UTERINE Frequency: "stat" Benzodiazepine C INTRA-UTERINE Methamphetamine C INTRA-UTERINE Mother uses methamphetami ne daily: 0.6-0.8g per day. Gentamicin C INTRA-UTERINE Dosing regimen: 80 (units unspecified) daily Nitrofurantoin C INTRA-UTERINE Dosing 22-Feb-2006 08:20 AM Page: 2246 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report regimen: 50 (units unspecified) every 6 hours 15 DAY Ranitidine C INTRA-UTERINE Dosing regimen: 2 x 150 (units unspecified) administered Panadol C INTRA-UTERINE Dosig regimen: 2 x 500 mg tablets as required Diazepam C INTRA-UTERINE Dosing regimen: 1-2 x 5mg tablets as required Date:08/24/04ISR Number: 4431202-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040806062 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS UNKNOWN Paxil C Remeron C Prinivil C Date:08/24/04ISR Number: 4431203-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040806416 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Risperdal PS OROPHARINGEAL Initial or Prolonged Rhabdomyolysis Professional Biperiden Hydrochloride SS OROPHARINGEAL Mecobalamin C OROPHARINGEAL Menatetrenone C OROPHARINGEAL Ethyl Icosapentate C OROPHARINGEAL Nicergoline C OROPHARINGEAL Date:08/24/04ISR Number: 4431204-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040806834 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:08/24/04ISR Number: 4431205-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040806836 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2247 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/24/04ISR Number: 4431318-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040805040 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leg Amputation Risperdal PS OROPHARINGEAL Initial or Prolonged Rhabdomyolysis Risperdal Consta SS INTRAMUSCULAR Date:08/24/04ISR Number: 4431320-2Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20030802863 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Risperdal PS OROPHARINGEAL Initial or Prolonged Dyskinesia Risperdal SS OROPHARINGEAL Other Extrapyramidal Disorder Oxazepam C Face Oedema Librium C OROPHARINGEAL Influenza Thyrax C OROPHARINGEAL Melaena Urinary Incontinence Vision Blurred Date:08/24/04ISR Number: 4433812-9Report Type:Direct Company Report #CTU 225498 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Vision Blurred Risperdal PS ORAL 1/4-1/2 QHS Vitreous Detachment ORAL Vitreous Floaters Librium C Nortryptiline C Date:08/25/04ISR Number: 4432081-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040803455 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Risperdal PS OROPHARINGEAL Initial or Prolonged Brachial Plexus Injury Haloperidol SS OROPHARINGEAL Contusion Biperiden Dialysis Hydrochloride SS OROPHARINGEAL Fall Brotizolam C OROPHARINGEAL Movement Disorder Muscle Atrophy Neuroleptic Malignant Syndrome Rhabdomyolysis Date:08/25/04ISR Number: 4432097-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040805048 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS UNKNOWN Clozapine C UNKNOWN Date:08/25/04ISR Number: 4432098-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040806976 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Risperdal PS OROPHARINGEAL 2 YR Risperdal SS OROPHARINGEAL 2 YR 22-Feb-2006 08:20 AM Page: 2248 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Reminyl C OROPHARINGEAL Antihypertensive C UNKNOWN Date:08/25/04ISR Number: 4432099-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040701923 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Glycosylated Haemoglobin Risperdal PS OROPHARINGEAL (taken at Increased night) Myocardial Infarction Risperdal SS OROPHARINGEAL Pneumonia Lanoxin C Actos C Accupril C Metformin C prior to 05/2002 Coumadin C prior to 05/2002 Lasix C prior to 05/2002 Humulin Insulin C started prior to 05/2002 Glucotrol Xl C decreased from twice daily to daily on 08-Apr-04 Date:08/25/04ISR Number: 4432100-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040807313 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Risperdal PS OROPHARINGEAL Fatigue Nausea Date:08/25/04ISR Number: 4434397-3Report Type:Expedited (15-DaCompany Report #04P-087-0270005-00 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Tasmolin (Akineton) Initial or Prolonged Consciousness Health (Biperiden) Hepatic Function Abnormal Professional (Biperiden) PS ORAL 2 MG, 1 IN 1 Hypoglycaemia D, PER ORAL : Pneumonia Aspiration 3 MG, PER Protein Total Decreased ORAL Lodopin(Zotepine) (Zotepine) (Zotepine) SS ORAL 100 MG, 1 IN 1 D, PER ORAL Quetiapine SS ORAL 300 MG, 1 IN 1 D, PER ORAL SEE IMAGE Risperidone SS ORAL 3 MG, 1 IN 1 D, PER ORAL Flunitrazepam SS ORAL 2 MG , 1 IN 1 D, PER ORAL Vegetamin SS ORAL PER ORAL 22-Feb-2006 08:20 AM Page: 2249 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/04ISR Number: 4433293-5Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20040604397 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Blinded; Galantamine PS OROPHARINGEAL 29 DAY Pain Blinded; Galantamine SS OROPHARINGEAL 29 DAY Placebo SS OROPHARINGEAL 29 DAY Risperidone SS OROPHARINGEAL Asaflow C OROPHARINGEAL Geratam C OROPHARINGEAL Actonel C OROPHARINGEAL Date:08/26/04ISR Number: 4435050-2Report Type:Direct Company Report #CTU 225731 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Risperdal (2 Mg Q Am Tongue Disorder , 2 Mg Q Pm) PS 2 MG Q AM, 2 Tremor MG Q PM Date:08/26/04ISR Number: 4435112-XReport Type:Direct Company Report #CTU 225708 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Risperdal 2 Mg PS ORAL 2 MG Q AM Tongue Disorder ORAL, 2 MG Q Tremor PM ORAL Date:08/26/04ISR Number: 4435762-0Report Type:Expedited (15-DaCompany Report #2004051190 Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Percentage Consumer Dilantin Infatabs Increased Health (Phenytoin Partial Seizures Professional Sodium) PS ORAL 200 MG (2 IN Pyrexia 1 D), ORAL Rash Erythematous Oxcarbazepine Rash Generalised (Oxcarbazepine) SS ORAL ORAL Rash Macular Risperidone (Risperidone) SS ORAL ORAL Date:08/27/04ISR Number: 4435064-2Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040806535 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cholelithiasis Risperdal Consta PS INTRAMUSCULAR Hospitalization - Coma Artane C UNKNOWN Initial or Prolonged Necrosis Pantozol C UNKNOWN Pancreatitis Date:08/27/04ISR Number: 4435065-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040802991 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Haemorrhage Health Risperdal PS OROPHARINGEAL Cerebral Infarction Professional Risperdal SS OROPHARINGEAL Vascular Occlusion Haloperidol C INTRAVENOUS 22-Feb-2006 08:20 AM Page: 2250 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/04ISR Number: 4435066-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040806922 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Risperdal PS OROPHARINGEAL Infarction Fluvoxamine Maleate C OROPHARINGEAL Cardiac Arrest Chlorpromazine-Prome Eating Disorder thazine Combined Fatigue Drug C OROPHARINGEAL Suicidal Ideation Perphenazine Maleate C OROPHARINGEAL Weight Decreased Date:08/27/04ISR Number: 4435067-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040806945 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS OROPHARINGEAL Date:08/27/04ISR Number: 4435068-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040602726 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Risperdal PS OROPHARINGEAL Initial or Prolonged Faecal Incontinence Risperdal SS OROPHARINGEAL Disability Feeling Abnormal Risperdal SS OROPHARINGEAL Other Feeling Drunk Risperdal SS OROPHARINGEAL Flushing Hallucination Hyperhidrosis Muscle Rigidity Retinal Scar Urinary Incontinence Verbal Abuse Visual Acuity Reduced Visual Disturbance Weight Increased Date:08/27/04ISR Number: 4435069-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040607460 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Health Risperdal PS OROPHARINGEAL Initial or Prolonged Convulsion Professional Leponex SS OROPHARINGEAL Other Delirium Depressed Level Of Consciousness Disorientation Drug Level Below Therapeutic Electroencephalogram Abnormal Hyponatraemia Rhabdomyolysis Somnolence Treatment Noncompliance Urinary Incontinence 22-Feb-2006 08:20 AM Page: 2251 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/27/04ISR Number: 4435070-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040602341 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Risperdal PS OROPHARINGEAL Respiratory Failure Professional Date:08/27/04ISR Number: 4435071-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040502151 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS OROPHARINGEAL Professional Depakote C OROPHARINGEAL Celexa C OROPHARINGEAL Nolvadex C OROPHARINGEAL Albuterol C OROPHARINGEAL 2 puffs every 4 hours prn for SOB Protonix C Maxzide C OROPHARINGEAL Maxzide C OROPHARINGEAL 75-25 mg Date:08/27/04ISR Number: 4435072-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040805048 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Risperdal PS UNKNOWN Professional Clozapine SS UNKNOWN Date:08/27/04ISR Number: 4437536-3Report Type:Expedited (15-DaCompany Report #GBWYE994523AUG04 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancreatitis Health Efexor (Venlafaxine Hospitalization - Renal Tubular Necrosis Professional Hydrochloride, Initial or Prolonged Other Tablet, 0) PS ORAL 150 MG 1X PER Disability 1 DAY ORAL Dianette (Cyproterone Acetate/Ethinylestra diol, , 0) SS ORAL ORAL Lithium (Lithium, , 0) SS ORAL 800 MG 1X PER 1 DAY ORAL Risperidone (Risperidone, 0) SS ORAL 3 MG 1X PER 1 DAY ORAL Date:08/30/04ISR Number: 4436375-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12498341 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Abilify PS Otsuka Initial or Prolonged Neuroleptic Malignant Pharmaceutical Other Syndrome Company, Ltd. ORAL 2 DAY Seroquel SS Risperdal SS Effexor C 22-Feb-2006 08:20 AM Page: 2252 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4436880-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040807522 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neoplasm Malignant Risperdal PS OROPHARINGEAL Cogentin C Effexor C Date:08/30/04ISR Number: 4436881-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040200144 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Risperdal PS OROPHARINGEAL Choking Risperdal SS OROPHARINGEAL Insomnia Risperdal SS OROPHARINGEAL Loss Of Consciousness Atenolol C Myelofibrosis Atorvastatin Calcium C Tachycardia Insulin C Transient Ischaemic Sevelamer Attack Hydrochloride C Tremor Benztropine Mesylate C Divalproex Sodium C Diphenhydramine Hydrochloride C Fluticasone Propionate C Vitamin B Complex C Vitamin B Complex C Vitamin B Complex C Vitamin B Complex C Vitamin B Complex C Epoetin Alfa C Date:08/30/04ISR Number: 4436882-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040600971 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Septal Defect Risperdal PS UNKNOWN Cardiomegaly Topiramate C Cardiomyopathy Augmentin C Dyspnoea Augmentin C Nasopharyngitis Actifed C Pulmonary Congestion Actifed C Patient had Pulmonary Oedema one dose on Snoring 21-May-02 Ventricular Hypertrophy Date:08/30/04ISR Number: 4437064-5Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0343205A Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancreatitis Consumer Lithium PS Glaxosmithkline ORAL 800MG Per day 187 WK Hospitalization - Renal Tubular Necrosis Venlafaxine SS ORAL 150MG Per day 48 WK Initial or Prolonged Risperidone SS ORAL 3MG Per day 105 WK Disability Dianette SS ORAL 31 WK 22-Feb-2006 08:20 AM Page: 2253 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/04ISR Number: 4437090-6Report Type:Periodic Company Report #US-JNJFOC-20040704058 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperidone PS OROPHARINGEAL Aricept C Date:08/30/04ISR Number: 4437606-XReport Type:Direct Company Report #CTU 225903 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Prozac PS Initial or Prolonged Resperidal SS Date:08/30/04ISR Number: 4438965-4Report Type:Expedited (15-DaCompany Report #2004AP02335 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Seroquel PS ORAL 300 MG DAILY Initial or Prolonged Increased Health PO Aspartate Professional Seroquel SS ORAL 250 MG DAILY Aminotransferase Other PO Increased Seroquel SS ORAL 100 MG DAILY Asthenia PO Blood Alkaline Seroquel SS ORAL 50 MG DAILY Phosphatase Increased PO Blood Lactate Lodopin SS ORAL 100 MG DAILY Dehydrogenase Increased PO Hepatic Function Abnormal Risperdal SS ORAL 3 MG DAILY PO Hypoglycaemia Tasmolin SS ORAL 3 MG DAILY PO Pneumonia Aspiration Tasmolin SS ORAL 2 MG DAILY PO Protein Total Decreased Rohypnol SS ORAL 2 MG DAILY PO Vegetamin SS Zyprexa C Date:08/31/04ISR Number: 4437907-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040807481 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drowning Risperdal PS UNKNOWN Mental Disorder Risperdal SS UNKNOWN Date:08/31/04ISR Number: 4437908-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040807700 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:08/31/04ISR Number: 4437909-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040805040 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leg Amputation Health Risperdal PS OROPHARINGEAL Initial or Prolonged Poor Peripheral Professional Risperdal Consta SS INTRAMUSCULAR Circulation Rhabdomyolysis 22-Feb-2006 08:20 AM Page: 2254 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/04ISR Number: 4437910-5Report Type:Expedited (15-DaCompany Report #NSADSS2002011264 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Abdomen Health Risperdal PS OROPHARINGEAL 0.5 inthe am Hospitalization - Acute Respiratory Professional and 1.0 mg in Initial or Prolonged Distress Syndrome the pm Agitation Zoloft C Chest Pain Atenolol C Lethargy Trazodone C Pleural Effusion Buspar C Pneumonia Klonopin C 1 mg in the Pneumothorax am and 2 mg Respiratory Failure at bedtime Sepsis Depakote C Staphylococcal Infection Vioxx C Date:08/31/04ISR Number: 4437911-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040808680 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:08/31/04ISR Number: 4437918-XReport Type:Periodic Company Report #US-JNJFOC-20040708079 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Health Risperdal PS UNKNOWN Professional Date:08/31/04ISR Number: 4439639-6Report Type:Direct Company Report #CTU 225964 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Priapism Risperidal 1mg/Ml Intervention to Urinary Retention Concentrate Janssen PS Janssen ORAL 2 MG QD ORAL Prevent Permanent Impairment/Damage Date:08/31/04ISR Number: 4457497-0Report Type:Periodic Company Report #US-JNJFOC-20040707378 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Consta Initial or Prolonged Schizophrenia Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Tablets SS ORAL 1.5MG, 1 IN 24 HOUR, ORAL 22-Feb-2006 08:20 AM Page: 2255 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/04ISR Number: 4457501-XReport Type:Periodic Company Report #US-JNJFOC-20040705060 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Risperdal Consta Initial or Prolonged Corrected Interval Professional (Risperidone) Prolonged Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Heart Rate Decreased WEEK, Overdose INTRA-MUSCULA R Risperidone (Risperidone) Tablets SS ORAL ORAL Oxcarbamazepine (Oxcarbazepine) C Ritalin (Methylphenidate Hydrochloride) C Trileptal (Oxcarbazepine) C Albuterol (Salbutamol) C Lisinopril (Lisinopril) C Darvocet (Propacet) C Lexapro (All Other Therapeutic Products) C Lithium (Lithium) C Date:08/31/04ISR Number: 4457506-9Report Type:Periodic Company Report #US-JNJFOC-20040607882 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Consumer Risperdal Consta Initial or Prolonged Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:08/31/04ISR Number: 4457509-4Report Type:Periodic Company Report #US-JNJFOC-20040604886 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Below Health Risperdal Consta Initial or Prolonged Therapeutic Professional (Risperidone) Psychotic Disorder Company Microspheres PS INTRAMUSCULAR 25 MG, 37.5 Representative MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperidone (Risperidone) Tablets SS 3 MG, 2 IN 1 DAY Seroquel (Quetiapine Fumurate) C Zantac (Ranitidine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 2256 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/04ISR Number: 4457512-4Report Type:Periodic Company Report #US-JNJFOC-20040603235 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Health Risperdal Consta Initial or Prolonged Drug Level Below Professional (Risperidone) Therapeutic Company Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Representative WEEK, INTR-MUSCULAR Risperdal (Risperidone) Unspecified SS 1 MG, 2 MG, 2 IN 1 DAY Prolixin D (Fluphenazine Deconate) C Seroquel (Quetiapine Fumurate) C Zoloft (Sertraline Hydrochloride) C Glucophage (Metformin Hydrochloride) C Insulin (Insulin) C Date:08/31/04ISR Number: 4457514-8Report Type:Periodic Company Report #US-JNJFOC-20040600299 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Consta Initial or Prolonged Psychotic Disorder Professional (Risperidone) Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:08/31/04ISR Number: 4457520-3Report Type:Periodic Company Report #US-JNJFOC-20040502153 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Micropheres PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:08/31/04ISR Number: 4457525-2Report Type:Periodic Company Report #US-JNJFOC-20040404320 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adverse Event Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Seroquel (Quetiapine Fumurate) C 22-Feb-2006 08:20 AM Page: 2257 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/01/04ISR Number: 4438828-4Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20040400582 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal Consta PS INTRAMUSCULAR Drug Level Decreased Professional Date:09/01/04ISR Number: 4438829-6Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20030902245 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Risperdal PS OROPHARINGEAL 110 DAY Initial or Prolonged Insulin-Dependent Risperdal SS OROPHARINGEAL 0.25 am and Other 0.5 pm 110 DAY Date:09/01/04ISR Number: 4438830-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040806922 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Health Risperdal PS OROPHARINGEAL Infarction Professional Fluvoxamine Maleate C OROPHARINGEAL Cardiac Arrest Chlorpromazine-Prome Fatigue thazine Combined Suicidal Ideation Drug C OROPHARINGEAL Weight Decreased Perphenazine Maleate C OROPHARINGEAL Date:09/01/04ISR Number: 4438831-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040806416 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Risperdal PS OROPHARINGEAL Initial or Prolonged Rhabdomyolysis Professional Biperiden Hydrochloride SS OROPHARINGEAL Mecobalamin C OROPHARINGEAL Menatetrenone C OROPHARINGEAL Ethyl Icosapentate C OROPHARINGEAL Nicergoline C OROPHARINGEAL Date:09/01/04ISR Number: 4438857-0Report Type:Expedited (15-DaCompany Report #200413215FR Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Lasilix 40 Mg PS Aventis Initial or Prolonged Consciousness Pharmaceuticals Inc. ORAL General Physical Health Risperdal SS ORAL Deterioration Seresta SS ORAL Stupor Fungizone SS ORAL Didronel SS ORAL Neo Mercazole SS ORAL Previscan C ORAL Zestril C ORAL Theostat C ORAL Nexxair C NASAL 22-Feb-2006 08:20 AM Page: 2258 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/01/04ISR Number: 4438906-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040808550 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS UNKNOWN Date:09/01/04ISR Number: 4438912-5Report Type:Expedited (15-DaCompany Report #PHHO2004CA11926 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Clozaril PS Novartis Sector: Phosphokinase Increased Pharma ORAL 550 mg, QD 300 DAY Dehydration Risperdal SS Muscle Rigidity Valproic Acid C Neuroleptic Malignant Syndrome Tachycardia Tonsillitis Date:09/01/04ISR Number: 4439090-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040808811 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Loss Of Consciousness Risperdal PS OROPHARINGEAL Initial or Prolonged Road Traffic Accident Date:09/01/04ISR Number: 4439451-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040808546 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS UNKNOWN Date:09/01/04ISR Number: 4439452-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040809752 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS UNKNOWN Date:09/01/04ISR Number: 4439453-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040809762 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS UNKNOWN Date:09/01/04ISR Number: 4439454-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040607188 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal PS OROPHARINGEAL 25 DAY Initial or Prolonged Parkinson'S Disease Haloperidol SS OROPHARINGEAL Thrombocytopenia Haloperidol SS OROPHARINGEAL Haloperidol SS OROPHARINGEAL In Apr-2004 the dose of haloperidol was increased. 22-Feb-2006 08:20 AM Page: 2259 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haloperidol SS OROPHARINGEAL On 23-JAN-04 oral admin of haloperidol was initiated. Prednisolone SS OROPHARINGEAL 169 DAY Promethazine Hydrochloride C OROPHARINGEAL Triazolam C OROPHARINGEAL Lormetazepam C OROPHARINGEAL Date:09/01/04ISR Number: 4440369-5Report Type:Direct Company Report #CTU 226085 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Risperdone Consta 25 Abnormal Mg PS INTRAVENOUS 25 MG Q 2 WEEKS IM Lithium C Perphenazine C Benztropine C Date:09/01/04ISR Number: 4440371-3Report Type:Direct Company Report #CTU 226086 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Liver Function Test Risperdone Consta 25 Abnormal Mg PS INTRAMUSCULAR 25 MG Q 2 WEEKS IM Lithium C Diphenhydramine C Date:09/01/04ISR Number: 4440417-2Report Type:Direct Company Report #CTU 226073 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatinine Risperdal 4 Mg PS ORAL 8 MG Q HS Increased ORAL Catatonia Amantadine C Dysarthria Dysphagia Hyperthermia Mental Status Changes Muscle Rigidity Neuroleptic Malignant Syndrome Date:09/01/04ISR Number: 4440446-9Report Type:Direct Company Report #CTU 226078 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Neutrophil Count Valproic Acid 500 Mg PS ORAL 500 MG AM HS Decreased ORAL White Blood Cell Count Risperidone 3 Mg SS ORAL 3 MG AM HS Decreased ORAL 22-Feb-2006 08:20 AM Page: 2260 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/02/04ISR Number: 4439945-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040808548 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Risperdal PS OROPHARINGEAL 1 YR Other Myocardial Infarction Insulin C SUBCUTANEOUS Date:09/02/04ISR Number: 4439946-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040808565 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Risperdal PS OROPHARINGEAL Other Sinus Bradycardia Propofol C Sertraline C Clozapine C Sevoflurane C Date:09/02/04ISR Number: 4439947-9Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040809453 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Risperdal PS Neuroleptic Malignant Risperdal SS Syndrome Combivir C Pneumonia Aspiration Combivir C Sepsis Septra Ds C Zithromax C Ativan C Septra Ds C Dilantin C Kaletra I Kaletra I Date:09/02/04ISR Number: 4439948-0Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040810137 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Risperdal PS OROPHARINGEAL Pericarditis Olanzapine SS OROPHARINGEAL Tachypnoea Clozapine SS OROPHARINGEAL Clozapine SS OROPHARINGEAL Date:09/02/04ISR Number: 4439949-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040801888 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS OROPHARINGEAL Professional Reminyl SS Date:09/02/04ISR Number: 4444600-1Report Type:Expedited (15-DaCompany Report #2004049916 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon (Ziprasidone) PS Syndrome Professional Risperidone (Risperidone) SS 22-Feb-2006 08:20 AM Page: 2261 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/03/04ISR Number: 4440781-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040602726 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Risperdal PS OROPHARINGEAL Initial or Prolonged Blood Pressure Risperdal SS OROPHARINGEAL Disability Fluctuation Risperdal SS OROPHARINGEAL Other Confusional State Risperdal SS OROPHARINGEAL Erythema Faecal Incontinence Feeling Abnormal Feeling Drunk Flushing Hallucination Hyperhidrosis Muscle Rigidity Retinal Scar Speech Disorder Urinary Incontinence Verbal Abuse Visual Disturbance Weight Increased Date:09/03/04ISR Number: 4440782-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040801640 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Risperdal PS OROPHARINGEAL Anxiety Professional Risperdal SS OROPHARINGEAL Epilepsy Risperdal SS OROPHARINGEAL Sudden Death Paracetamol C UNKNOWN Diprobase C UNKNOWN Diprobase C UNKNOWN Diprobase C UNKNOWN Diprobase C UNKNOWN Date:09/03/04ISR Number: 4440783-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040809752 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS UNKNOWN Professional Reminyl SS Date:09/03/04ISR Number: 4440784-XReport Type:Periodic Company Report #US-JNJFOC-20040801888 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS OROPHARINGEAL Professional Reminyl SS Zoloft C Depakote C Date:09/03/04ISR Number: 4440785-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040801550 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Health Risperdal PS OROPHARINGEAL Professional Paxil C 22-Feb-2006 08:20 AM Page: 2262 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Albuterol C Lipitor C Tylenol C Aspirin C Atenolol C Sublingual Nitroglycerin C Sublingual Nitroglycerin C Sublingual Nitroglycerin C Sublingual Nitroglycerin C Sublingual Nitroglycerin C Detrol La C Date:09/03/04ISR Number: 4440786-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040701923 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Decreased Health Risperdal PS OROPHARINGEAL (taken at General Physical Health Professional night) Deterioration Risperdal SS OROPHARINGEAL International Normalised Lanoxin C Ratio Increased Actos C Myocardial Infarction Accupril C Pneumonia Metformin C prior to Prothrombin Time 05/2002 Prolonged Coumadin C prior to 05/2002 Lasix C prior to 05/2002 Humulin Insulin C started prior to 05/2002 Glucotrol Xl C decreased from twice daily to daily on 08-Apr-04 Date:09/07/04ISR Number: 4441640-3Report Type:Periodic Company Report #US-JNJFOC-20040802066 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS OROPHARINGEAL Hospitalization - Professional Initial or Prolonged Date:09/07/04ISR Number: 4442048-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040809804 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Health Risperdal PS OROPHARINGEAL Professional 22-Feb-2006 08:20 AM Page: 2263 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/04ISR Number: 4442063-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040807491 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Health Risperdal PS OROPHARINGEAL Hospitalization - Pancreatitis Professional Venlafaxine SS OROPHARINGEAL Initial or Prolonged Renal Tubular Necrosis Lithium SS OROPHARINGEAL Disability Dianette SS OROPHARINGEAL Dianette SS OROPHARINGEAL Date:09/07/04ISR Number: 4445060-7Report Type:Expedited (15-DaCompany Report #04P-087-0270005-00 Age:69 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Tasmolin (Akineton) Initial or Prolonged Consciousness Health (Biperiden) Hepatic Function Abnormal Professional (Biperiden) PS ORAL 3 MG, 1 IN 1 Hypoglycaemia D, PER ORAL Pneumonia Aspiration Lodopin (Zotepine) SS ORAL 100 MG, 3 IN Protein Total Decreased 1 D, PER ORAL Quetiapine SS ORAL 100 MG, 3 IN 1 D, PER ORAL Risperidone SS ORAL 1 MG, 3 IN 1 D, PER ORAL Flunitrazepam SS ORAL 2 MG, 1 IN 1 D, PER ORAL Vegetamin SS ORAL PER ORAL Olanzapine C Date:09/07/04ISR Number: 4455027-0Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20040809666 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Risperdal PS OROPHARINGEAL Thrombocytopenia Cipralex SS OROPHARINGEAL Date:09/08/04ISR Number: 4443191-9Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20030802863 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Abnormal Sensation In Eye Initial or Prolonged Antipsychotic Drug Level Other Above Therapeutic Arrhythmia Diarrhoea Dizziness Drug Intolerance Dry Mouth Dyskinesia Emotional Disorder Extrapyramidal Disorder Face Oedema Fatigue Generalised Oedema Haemorrhage Headache Hypothyroidism Influenza Keratoconjunctivitis 22-Feb-2006 08:20 AM Page: 2264 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sicca Masked Facies Melaena Musculoskeletal Stiffness Report Source Product Role Manufacturer Route Dose Duration Strabismus Health Risperdal PS OROPHARINGEAL Therapy Non-Responder Professional Risperdal SS OROPHARINGEAL Urinary Incontinence Oxazepam C Vision Blurred Librium C OROPHARINGEAL Thyrax C OROPHARINGEAL Date:09/08/04ISR Number: 4443607-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040900526 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS UNKNOWN Date:09/08/04ISR Number: 4445067-XReport Type:Direct Company Report #CTU 226549 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Risperdal Consta 25 Initial or Prolonged Dysstasia Mg Jannsen PS Jannsen INTRAMUSCULAR 25 MG Q 2 Faecal Incontinence WEEKS IM Risperidone 2 Mg Jannsen SS Jannsen ORAL 2 MG ORAL HS Fluoxetine C Cyproheptidine C Baclofen C Benadryl C Date:09/08/04ISR Number: 4446703-4Report Type:Expedited (15-DaCompany Report #FRP04000719 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Foreign Didronel (Etidronate Initial or Prolonged Depressed Level Of Health Disodium) Tablet PS ORAL ORAL Consciousness Professional Fungizone Other (Amphotericin B) SS Neo Mercazole (Carbimazole) SS ORAL ORAL Risperdal (Risperidone) SS ORAL 0.1 ML, DAILY, ORAL Lasilix (Furosemide) SS ORAL ORAL Seresta (Oxazepam) SS ORAL ORAL Risperdal (Risperidone) C ORAL 0.1 ML, DAILY, ORAL Previscan (Fluindione) C Zestril (Lisinopril) C Theostat(Theophyllin e) C Beclometasone (Beclometasone) C 22-Feb-2006 08:20 AM Page: 2265 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/04ISR Number: 4444776-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040809683 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Health Risperdal PS OROPHARINGEAL 252 DAY Initial or Prolonged Thrombocytopenia Professional Leponex SS OROPHARINGEAL 28 MON Lepticur C Noctran C Noctran C Noctran C Rivotril C Depakote C Date:09/09/04ISR Number: 4444777-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040900519 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal Consta PS INTRAMUSCULAR Decreased Date:09/09/04ISR Number: 4444778-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040901175 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Vasculitis Risperdal PS OROPHARINGEAL Date:09/09/04ISR Number: 4444779-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040901777 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:09/09/04ISR Number: 4444780-8Report Type:Periodic Company Report #US-JNJFOC-20040704895 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Health Risperdal PS OROPHARINGEAL Professional Date:09/09/04ISR Number: 4448805-5Report Type:Expedited (15-DaCompany Report #2004GB02064 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Interaction Foreign Seroquel PS ORAL 25 MG QD PO Intervention to Dyskinesia Health Seroquel SS ORAL 25 MG BID PO Prevent Permanent Eating Disorder Professional Risperidone SS 500 MG BID Impairment/Damage Emotional Distress Other Risperidone SS 500 MG QD Paranoia Tongue Disorder Tremor 22-Feb-2006 08:20 AM Page: 2266 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/10/04ISR Number: 4445590-8Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12689394 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Fungizone PS Apothecon Initial or Prolonged Consciousness Didronel SS ORAL Neo-Mercazole SS ORAL Seresta SS ORAL 16 DAY Risperidal SS ORAL 16 DAY Lasilix SS ORAL Previscan C interrupted on 21-Jun-2004 and resumed on an Zestril C interrupted on 21-Jun-2004 and resumed on an Theostat C interrupted on 21-Jun-2004 and resumed on an Nexxair C interrupted on 21-Jun-2004 and resumed on an Date:09/10/04ISR Number: 4445685-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040702328 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Risperdal PS OROPHARINGEAL Condition Aggravated Professional Risperdal SS OROPHARINGEAL Constipation Risperdal SS OROPHARINGEAL Extrapyramidal Disorder Risperdal SS OROPHARINGEAL Leukopenia Risperdal SS OROPHARINGEAL Muscle Rigidity Risperdal SS OROPHARINGEAL Psychiatric Symptom Risperdal SS OROPHARINGEAL Thirst Flunitrazepam C OROPHARINGEAL Tremor Trihexyphenidyl Weight Increased Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Etizolam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Olanzapine C OROPHARINGEAL 51 DAY Olanzapine C OROPHARINGEAL 51 DAY Quazepam C OROPHARINGEAL 56 DAY Quazepam C OROPHARINGEAL 56 DAY 22-Feb-2006 08:20 AM Page: 2267 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Quazepam C OROPHARINGEAL 56 DAY Quazepam C OROPHARINGEAL 56 DAY Sennoside C Sennoside C Brotizolam C Brotizolam C Magnesium Oxide C Magnesium Oxide C Magnesium Oxide C Date:09/10/04ISR Number: 4445688-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040900961 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Risperdal PS OROPHARINGEAL Initial or Prolonged Increased Haldol SS INTRAVENOUS solution Blood Creatine injectable 5 Phosphokinase Increased mg 1 DAY Drug Interaction Loxapac C UNKNOWN Tercian C UNKNOWN Date:09/10/04ISR Number: 4445857-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040805040 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Leg Amputation Health Risperdal PS OROPHARINGEAL Hospitalization - Rhabdomyolysis Professional Diazepam C OROPHARINGEAL Initial or Prolonged Diazepam C OROPHARINGEAL Date:09/10/04ISR Number: 4445949-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040902263 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Patient was taking .5 mg tablet(s), but dosage was unknown. Date:09/10/04ISR Number: 4445950-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040902332 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:09/10/04ISR Number: 4445951-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040902335 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2268 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/10/04ISR Number: 4445952-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040902336 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Hallucination Methamphetamine SS Self-Medication Concerta C UNKNOWN Date:09/10/04ISR Number: 4446041-XReport Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0343968A Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Bullous Consumer Deroxat PS Glaxosmithkline ORAL 20MG Per day Initial or Prolonged Pruritus Risperdal SS ORAL 1MG Per day 19 MON Densical SS Glaxosmithkline ORAL 1UNIT Per day Transipeg SS ORAL 2UNIT per day Tiapridal C ORAL 5DROP per day Date:09/10/04ISR Number: 4446054-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040902334 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Risperdal PS OROPHARINGEAL Reminyl SS OROPHARINGEAL Date:09/13/04ISR Number: 4447636-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040900511 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Increased Health Risperdal PS OROPHARINGEAL Initial or Prolonged Somnolence Professional Rivotril SS OROPHARINGEAL Antadys SS OROPHARINGEAL Date:09/13/04ISR Number: 4447637-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040900986 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Risperdal PS Date:09/13/04ISR Number: 4447638-3Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20040901428 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Insipidus Risperdal PS OROPHARINGEAL Date:09/13/04ISR Number: 4447639-5Report Type:Expedited (15-DaCompany Report #NSADSS2003024184 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Interaction Health Procrit PS 8 DAY Initial or Prolonged Grand Mal Convulsion Professional Celexa SS UNKNOWN Risperdal SS UNKNOWN Alcohol SS Combivir C Combivir C Kaletra C 22-Feb-2006 08:20 AM Page: 2269 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Kaletra C Date:09/13/04ISR Number: 4447778-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040702326 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Risperdal PS White Blood Cell Count Risperdal SS Decreased Lorazepam C Biperiden Hydrochloride C Chlorpromazine Tannate C Chlorpromazine Tannate C Chlorpromazine Tannate C Chlorpromazine Tannate C Chlorpromazine Tannate C Chlorpromazine Tannate C Chlorpromazine Tannate C Chlorpromazine Tannate C Brotizolam C Brotizolam C Brotizolam C Date:09/13/04ISR Number: 4450679-3Report Type:Direct Company Report #CTU 226952 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Difficulty In Walking Risperdal / Janssen Drug Interaction Pharmaceuticals PS Janssen Dyskinesia Pharmacenticals 0.5 MG BY Gait Disturbance MOUTH TWICE A DAY Reglan SS 10 MG BY MOUTH DAILY Date:09/14/04ISR Number: 4450740-3Report Type:Direct Company Report #CTU 226988 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Health Risperidal 1 Mg PS 1 MG PO BID Professional Zyprexa C Date:09/14/04ISR Number: 4450741-5Report Type:Direct Company Report #CTU 226989 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Risperidal PS ORAL 4 MG PO HS Seroquel C 22-Feb-2006 08:20 AM Page: 2270 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/04ISR Number: 4449859-2Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040902726 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Risperdal Consta PS INTRAMUSCULAR Clonazepam C OROPHARINGEAL Zoplicone C OROPHARINGEAL Benztropine C OROPHARINGEAL Citalopram C Date:09/15/04ISR Number: 4449860-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040606909 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Consumer Risperdal PS OROPHARINGEAL Malignant Pancreatic Carcinoma Renal Failure Date:09/15/04ISR Number: 4449868-3Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20040901431 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Periorbital Oedema Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Urticaria Disipal C Panodil C Propavan C Nozinan C Apozepam C Zantac C Cisordinol C Zopiklon C Date:09/15/04ISR Number: 4450027-9Report Type:Expedited (15-DaCompany Report #PHBS2004JP11891 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Ritaline PS Novartis Sector: Professional Pharma ORAL Tegretol SS ORAL Akineton SS ORAL Erimin SS ORAL Wintermin SS ORAL Risperdal SS ORAL Depas SS ORAL Myslee SS ORAL Date:09/15/04ISR Number: 4451231-6Report Type:Direct Company Report #CTU 227237 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Risperdal 3 Mg Initial or Prolonged Janssen PS Janssen ORAL 3 MG PO HS 5 DAY 22-Feb-2006 08:20 AM Page: 2271 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/04ISR Number: 4451609-0Report Type:Expedited (15-DaCompany Report #2004031828 Age:68 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Foreign Sortis Initial or Prolonged Cerebral Disorder Health (Atorvastatin) PS ORAL 20 MG (20 MG, Circadian Rhythm Sleep Professional 1 IN 1 D), Disorder Company ORAL Confusional State Representative Carvedilol Faecal Incontinence (Carvedilol) SS ORAL 50 MG (25 MG, Myalgia 2 IN 1 D), Restlessness ORAL Sleep Disorder Candesartan Urinary Incontinence Cilexetil (Candesartan Cilexetil) SS ORAL 16 MG (8 MG, 2 IN 1 D), ORAL Molsidomine (Molsidomine) SS ORAL 8 MG (8 MG, 1 IN 1 D), ORAL Risperidone (Risperidone) SS ORAL 1 MG (1 MG, 1 IN 1 D), ORAL Zopiclone (Zopiclone) SS ORAL 7.5 MG (7.5 MG, AS NECESSARY), ORAL Isosoride Dinitrate (Isosorbide Dinitrate) C Moxonidine (Moxonidine) C Acetylsalicylic Acid (Acetylsalicylic Acid) C Insulin Human Injection, Isophane (Insulin Human Injection, Isophane) C Pipamperone (Pipamperone) C Diazepam (Diazepam) C Metamizole Sodium (Metamizole Sodium) C Date:09/15/04ISR Number: 4451846-5Report Type:Direct Company Report #CTU 227113 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Risperdal Various Initial or Prolonged Hypothermia Strengths Janssen PS Janssen Rhabdomyolysis Lexapro C Valproic Acid C Tetracycline C Retin-A Cream C Ascorbic Acid C Ferrous Sulfate C Oscal C 22-Feb-2006 08:20 AM Page: 2272 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/16/04ISR Number: 4451390-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040902881 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Risperdal PS OROPHARINGEAL Iron Supplement C Coumadin C Coumadin C Lasix C Ativan C Nexium C Aricept C Lexapro C 1/2 of a 20 mg dose. Tylenol C Date:09/16/04ISR Number: 4451391-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040902890 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Exelon C Date:09/16/04ISR Number: 4451392-9Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040706707 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Cholesterol Health Risperdal PS OROPHARINGEAL 48 MON Increased Professional Zyprexa SS OROPHARINGEAL 11 MON Blood Glucose Increased Sertraline C OROPHARINGEAL Blood Triglycerides Temazepam C dose taken at Increased night Cholecystitis Clonazepam C dose taken at Cholelithiasis night Obstructive Trazodone C dose taken at Circulatory Collapse night Cough Diabetic Ketoacidosis Hepatic Steatosis Hypothyroidism Pancreatitis Acute Polydipsia Polyuria Pulmonary Oedema Reflux Oesophagitis Thyroid Atrophy Date:09/16/04ISR Number: 4451393-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040801819 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Risperdal PS OROPHARINGEAL Professional 22-Feb-2006 08:20 AM Page: 2273 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/16/04ISR Number: 4451461-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040701114 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Risperdal PS OROPHARINGEAL Phosphokinase Increased Professional Flunitrazepam C OROPHARINGEAL Excitability Teprenone C OROPHARINGEAL Haemoglobin Decreased Lorazepam C OROPHARINGEAL Irritability Lansoprazole C OROPHARINGEAL Lithium Carbonate C OROPHARINGEAL Levomepromazine Maleate C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL Date:09/16/04ISR Number: 4452491-8Report Type:Expedited (15-DaCompany Report #MK200408-0258-1 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Anafranil Capsules Initial or Prolonged Aminotransferase 100 PS 150 MG, DAILY Increased Risperdal SS Blood Pressure Systolic Wintermin SS Increased Luvox SS Cold Sweat Daonil C Dehydration Basen C Dyspnoea Akineton C Erythema Deas C Heart Rate Increased Rohypnol C Hyperhidrosis Zolpidem C Hyperthermia Hyperventilation Hypoaesthesia Myoglobinuria Neuroleptic Malignant Syndrome Palpitations Panic Disorder Tachypnoea Thirst Tremor White Blood Cell Count Increased Date:09/16/04ISR Number: 4452510-9Report Type:Expedited (15-DaCompany Report #2004062825 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Neurontin Initial or Prolonged Drug Interaction Health (Gabapentin) PS Other Generalised Oedema Professional Risperidone Company (Risperidone) SS Representative All Other Therapetutic 22-Feb-2006 08:20 AM Page: 2274 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Products (All Other Therapeutic Products) C Date:09/17/04ISR Number: 4452130-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040706065 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiolipin Antibody Risperdal PS OROPHARINGEAL Neutropenia Risperdal SS OROPHARINGEAL Thrombocytopenia Risperdal SS OROPHARINGEAL Risperdal Consta SS INTRAMUSCULAR Risperdal SS OROPHARINGEAL Date:09/17/04ISR Number: 4452148-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040902800 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Risperdal Consta PS INTRAMUSCULAR Date:09/17/04ISR Number: 4452149-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040903190 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Risperdal Consta PS INTRAMUSCULAR Glaucoma Date:09/17/04ISR Number: 4452387-1Report Type:Expedited (15-DaCompany Report #PHBS2004JP11891 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Ritaline PS Novartis Sector: Pharma ORAL Tegretol SS ORAL Akineton SS ORAL Erimin SS ORAL Wintermin SS ORAL Risperdal SS ORAL Depas SS ORAL Myslee SS ORAL Date:09/20/04ISR Number: 4453361-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040701114 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Risperdal PS OROPHARINGEAL Phosphokinase Increased Professional Flunitrazepam C OROPHARINGEAL Excitability Teprenone C OROPHARINGEAL Haemoglobin Decreased Lorazepam C OROPHARINGEAL Lansoprazole C OROPHARINGEAL Lithium Carbonate C OROPHARINGEAL Levomepromazine Maleate C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2275 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fk C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL Date:09/20/04ISR Number: 4453387-8Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20040901431 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Periorbital Oedema Health Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Urticaria Professional Disipal C Panodil C Propavan C Nozinan C Apozepam C Zantac C Cisordinol C Zopiklon C Date:09/20/04ISR Number: 4453439-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040902881 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Risperdal PS OROPHARINGEAL Professional Iron Supplement C Coumadin C Coumadin C Lasix C Ativan C Nexium C Aricept C Lexapro C 1/2 of a 20 mg dose. Tylenol C Date:09/20/04ISR Number: 4453440-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040902890 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS OROPHARINGEAL Professional Exelon C Date:09/20/04ISR Number: 4453441-0Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040706707 Age: Gender:Female I/FU:I Outcome PT Death Blood Cholesterol Increased Blood Glucose Increased Blood Triglycerides Increased Cholecystitis Chronic Cholelithiasis Obstructive Diabetic Ketoacidosis Hepatic Steatosis Hypothyroidism 22-Feb-2006 08:20 AM Page: 2276 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pancreatitis Acute Polydipsia Polyuria Report Source Product Role Manufacturer Route Dose Duration Pulmonary Congestion Health Risperdal PS OROPHARINGEAL 48 MON Reflux Oesophagitis Professional Zyprexa SS OROPHARINGEAL 11 MON Thyroid Atrophy Sertraline C OROPHARINGEAL Temazepam C dose taken at night Clonazepam C dose taken at night Trazodone C dose taken at night Date:09/20/04ISR Number: 4453442-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040801819 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Lung Neoplasm Malignant Health Risperdal PS OROPHARINGEAL Professional Date:09/20/04ISR Number: 4453488-4Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040902726 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Choking Health Risperdal Consta PS INTRAMUSCULAR Professional Clonazepam C OROPHARINGEAL Zoplicone C OROPHARINGEAL Benztropine C OROPHARINGEAL Citalopram C Date:09/20/04ISR Number: 4453489-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040606909 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Consumer Risperdal PS OROPHARINGEAL Malignant Pancreatic Carcinoma Renal Failure Date:09/20/04ISR Number: 4453774-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040903733 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Risperdal PS OROPHARINGEAL Initial or Prolonged Corrected Interval Risperdal SS OROPHARINGEAL Prolonged Date:09/20/04ISR Number: 4453775-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040904088 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS UNKNOWN 22-Feb-2006 08:20 AM Page: 2277 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/04ISR Number: 4454562-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040902803 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Health Risperdal PS OROPHARINGEAL Initial or Prolonged Lymphopenia Professional Tercian SS OROPHARINGEAL Neutropenia Date:09/21/04ISR Number: 4454563-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040904415 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Risperdal PS OROPHARINGEAL Asthenia Depakote C Blood Urea Increased Synthroid C Bronchitis Depakote C Cerebrovascular Disorder Paxil C Chronic Obstructive Lithium C Pulmonary Disease Fall Hyperglycaemia Leukocytosis Microangiopathy Nuclear Magnetic Resonance Imaging Brain Abnormal Oedema Mucosal Pneumonia Tardive Dyskinesia Ventricular Hypertrophy Date:09/21/04ISR Number: 4454564-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040904697 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:09/21/04ISR Number: 4454565-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040904698 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:09/21/04ISR Number: 4454566-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040904965 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal Consta PS Date:09/21/04ISR Number: 4454567-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040905002 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS 22-Feb-2006 08:20 AM Page: 2278 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/21/04ISR Number: 4454762-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040810131 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Percentage Risperdal PS OROPHARINGEAL Decreased Biperiden Mean Cell Haemoglobin Hydrochloride C OROPHARINGEAL Increased Alprazolam C OROPHARINGEAL Zinc Sulphate Turbidity Flunitrazepam C OROPHARINGEAL Decreased Zonisamide C OROPHARINGEAL Levomepromazine Maleate C OROPHARINGEAL Magnesium Oxide C OROPHARINGEAL Date:09/22/04ISR Number: 4455607-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040903197 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Insipidus Risperdal PS OROPHARINGEAL Date:09/22/04ISR Number: 4455608-4Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20040904269 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Attention Risperdal PS OROPHARINGEAL 2-6 mg/day Initial or Prolonged Dysphagia (when Mutism necessary) Pyrexia Risperdal SS OROPHARINGEAL Speech Disorder Valproat C taken for the last 2 weeks with Risperdal 5 mg/day Date:09/22/04ISR Number: 4455609-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040900961 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Risperdal PS OROPHARINGEAL Initial or Prolonged Increased Haldol SS INTRAVENOUS solution Blood Creatine injectable 5 Phosphokinase Increased mg 1 DAY Drug Interaction Tercian C UNKNOWN Rhabdomyolysis Levomepromazine C Date:09/22/04ISR Number: 4455610-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040905851 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Risperdal PS OROPHARINGEAL 8 MON Date:09/22/04ISR Number: 4455611-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040904415 Age: Gender:Female I/FU:I Outcome PT Other Abdominal Pain Anxiety 22-Feb-2006 08:20 AM Page: 2279 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Asthenia Blood Glucose Increased Blood Urea Increased Report Source Product Role Manufacturer Route Dose Duration Body Temperature Risperdal PS OROPHARINGEAL Increased Depakote C Bronchitis Synthroid C Cerebrovascular Accident Depakote C Cerebrovascular Disorder Paxil C Chronic Obstructive Lithium C Pulmonary Disease Cognitive Deterioration Cough Dyskinesia Dysphagia Dystonia Faecal Incontinence Fall Gait Disturbance Gastrointestinal Mucosal Disorder General Physical Health Deterioration Heart Rate Increased Hepatitis B Hyperglycaemia Mastication Disorder Mental Impairment Oedema Mucosal Pain In Extremity Parkinsonism Platelet Count Decreased Pneumonia Posture Abnormal Protein Urine Present Respiratory Rate Increased Tardive Dyskinesia Urinary Incontinence Ventricular Hypertrophy Date:09/22/04ISR Number: 4455612-6Report Type:Expedited (15-DaCompany Report #PHBS2004JP11891 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pain Health Ritaline PS Novartis Sector: Priapism Professional Pharma ORAL Tegretol SS ORAL Akineton SS ORAL Erimin SS ORAL Wintermin SS ORAL Risperdal SS ORAL Depas SS ORAL Myslee SS ORAL Serenzin SS 22-Feb-2006 08:20 AM Page: 2280 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/04ISR Number: 4455727-2Report Type:Expedited (15-DaCompany Report #JP-ABBOTT-04P-087-0270005-00 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Tasmolin PS ORAL Initial or Prolonged Consciousness Tasmolin SS ORAL Hepatic Function Abnormal Tasmolin SS ORAL Hypoglycaemia Lodopin SS ORAL 120 DAY Pneumonia Aspiration Quetiapine SS ORAL Protein Total Decreased Quetiapine SS ORAL Quetiapine SS ORAL Quetiapine SS ORAL Quetiapine SS Quetiapine SS Quetiapine SS Risperidone SS ORAL Risperidone SS Flunitrazepam SS ORAL 182 DAY Vegetamin SS ORAL 182 DAY Olanzapine C ORAL 41 DAY Date:09/22/04ISR Number: 4455936-2Report Type:Expedited (15-DaCompany Report #NZ-JNJFOC-20040905216 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Risperdal Consta PS INTRAMUSCULAR Prolonged Sodium Valproate C Date:09/22/04ISR Number: 4455937-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040906003 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS UNKNOWN Date:09/22/04ISR Number: 4458057-8Report Type:Expedited (15-DaCompany Report #A01200404339 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Po2 Increased Foreign Zolpidem Tartrate PS Initial or Prolonged Priapism Literature Depas - (Etizolam) - Surgical Procedure Health Unknown - Unit Dose Repeated Professional : Unknown SS Other Ritalin - (Methylphenidate Hydrochloride) - Unknown - Unit Dose : Unknown SS Akineton - (Biperiden Hydrochloride) - Unknown - Unit Dose : Unknown SS (Nimetazepam) - Unknown - Unit Dose : Unknown SS Wintermin - (Chlorpromazine Hydrochloride) - Unknown - Unit Dose 22-Feb-2006 08:20 AM Page: 2281 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report : Unknown SS Tegretol - (Carbamazepine) - Unknown - Unit Dose : Unknown SS Risperdal - (Risperidone) - U Nknown - Unit Dose : Unknown SS Serenzin - (Diazepam) - Unknown - Unit Dose : Unknown SS Date:09/22/04ISR Number: 4458833-1Report Type:Direct Company Report #CTU 227785 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Risperdal 1 Mg Q Day PS Janssen 0.25 AM & 1 Disability Insulin-Dependent MG EVES Zoloft C Date:09/23/04ISR Number: 4456965-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040601726 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Increased Risperdal PS OROPHARINGEAL Blood Creatine Semisodium Valproate C Phosphokinase Increased Omega 3 C Blood Pressure Increased Thyroxine C Confusional State Ketoconazole C 1-2 weekly Transient Ischaemic Oxytetracycline C Attack Procyclidine C Date:09/24/04ISR Number: 4457889-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040903781 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Risperdal Consta PS INTRAMUSCULAR duration of Hospitalization - Drug Interaction therapy: Initial or Prolonged Electrocardiogram Qt months Prolonged Akineton C OROPHARINGEAL taken as Inappropriate needed Antidiuretic Hormone Eunerpan I OROPHARINGEAL duration of Secretion therapy: Polydipsia months Date:09/24/04ISR Number: 4457890-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040904260 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Risperdal PS OROPHARINGEAL 13 DAY Initial or Prolonged Drug Interaction Haldol SS Tonsillitis Loxapac SS Rivotril SS OROPHARINGEAL Depamide SS OROPHARINGEAL Tercian C OROPHARINGEAL 40 mg/ml Zyprexa C 22-Feb-2006 08:20 AM Page: 2282 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Akineton Retard C Clopixol C Date:09/24/04ISR Number: 4457891-8Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040905215 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperdal Consta PS INTRAMUSCULAR dose to be Initial or Prolonged increased to 37.5 mg at next administratio Diazepam C Paroxetine C Date:09/24/04ISR Number: 4457892-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040803503 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Risperdal PS OROPHARINGEAL 17 DAY Life-Threatening Cardiac Failure Risperdal SS OROPHARINGEAL 17 DAY Hospitalization - Confusional State Comtess C OROPHARINGEAL Initial or Prolonged Constipation Nacom C OROPHARINGEAL Other Dysphagia Nacom C OROPHARINGEAL Dysphonia Parkinsan C OROPHARINGEAL Dyspnoea Fluid Intake Reduced Heart Rate Increased Heart Rate Irregular Injury Localised Oedema Medication Error Mucous Membrane Disorder Oliguria Refusal Of Treatment By Patient Somnolence Date:09/24/04ISR Number: 4457893-1Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040405310 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cryptogenic Organizing Risperdal PS OROPHARINGEAL Pneumonia Date:09/24/04ISR Number: 4457894-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040803455 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dialysis Risperdal PS OROPHARINGEAL Initial or Prolonged Fall Haloperidol SS OROPHARINGEAL Injury Biperiden Joint Dislocation Hydrochloride SS OROPHARINGEAL Muscle Atrophy Brotizolam C OROPHARINGEAL Neuroleptic Malignant Syndrome Rhabdomyolysis 22-Feb-2006 08:20 AM Page: 2283 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/24/04ISR Number: 4457971-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040906352 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS UNKNOWN Date:09/24/04ISR Number: 4458112-2Report Type:Expedited (15-DaCompany Report #FR-MERCK-0409FRA00072 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Zocor PS Merck & Co., Inc ORAL Initial or Prolonged Dysstasia Professional Acepromazine And Fall Aceprometazine And Rhabdomyolysis Clorazepate Dipotassium SS ORAL Fluoxetine Hydrochloride SS ORAL Zopiclone SS ORAL Risperidone SS ORAL Levothyroxine Sodium C ORAL Date:09/24/04ISR Number: 4458173-0Report Type:Expedited (15-DaCompany Report #CA-ABBOTT-04P-028-0272719-00 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Epival Tablets PS ORAL 370 DAY Initial or Prolonged Condition Aggravated Epival Tablets SS ORAL 370 DAY Hepatic Enzyme Increased Ritonavir Soft Hepatotoxicity Gelatin Capsules SS ORAL 786 DAY Hypomania Ritonavir Soft Nausea Gelatin Capsules SS ORAL 786 DAY Psychotic Disorder Tipranavir SS ORAL 787 DAY Schizophrenia Procyclidine SS ORAL 151 DAY Vomiting Olanzapine SS ORAL 3 YR Olanzapine SS ORAL 3 YR Risperidone SS ORAL 46 DAY Trazodone SS ORAL Quetiapine SS ORAL 23 DAY Lamivudine C ORAL Abacavir C ORAL Paracetamol C ORAL 618 DAY Atovaquone C ORAL Calcium Carbonate C ORAL Magic Mouthwash C Nystatin C ORAL Megavim C ORAL Date:09/24/04ISR Number: 4458218-8Report Type:Periodic Company Report #US-JNJFOC-20040704130 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal M-Tabs PS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2284 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/04ISR Number: 4459091-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040905835 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholestasis Health Risperdal Consta PS INTRAMUSCULAR Drug Interaction Professional Risperdal Consta SS INTRAMUSCULAR Lorazepam C OROPHARINGEAL 2 DAY Clopixol I INTRAMUSCULAR Date:09/27/04ISR Number: 4459223-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040802826 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Risperdal PS OROPHARINGEAL (taken at Drug Level Below bedtime) Therapeutic Risperdal SS OROPHARINGEAL Homicidal Ideation Ultram SS OROPHARINGEAL Psychotic Disorder Dilantin C Suicidal Ideation Ibuprofen C Dapsone C Trazodone C 50-100 mg nightly Date:09/27/04ISR Number: 4459239-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040905265 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antidepressant Drug Level Risperdal PS OROPHARINGEAL Initial or Prolonged Increased Tercian SS OROPHARINGEAL Drug Interaction Depamide SS OROPHARINGEAL Drug Level Increased Laroxyl I OROPHARINGEAL Laroxyl I OROPHARINGEAL Date:09/27/04ISR Number: 4462685-3Report Type:Expedited (15-DaCompany Report #2004UW19322 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Seroquel PS ORAL 300 MG BID PO Initial or Prolonged Hallucination, Auditory Health Risperdal SS ORAL 1.5 MG BID PO Psychotic Disorder Professional Zoloft C Suicidal Ideation Ativan C Aspirin C Date:09/27/04ISR Number: 4575364-9Report Type:Direct Company Report #CTU 238298 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Risperidone PS 3 MG PO; Initial or Prolonged 25MG CONSTA, PO & IM Date:09/28/04ISR Number: 4461051-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040907721 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Risperdal PS OROPHARINGEAL Prolonged 22-Feb-2006 08:20 AM Page: 2285 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/04ISR Number: 4461171-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040706065 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antinuclear Antibody Health Risperdal PS OROPHARINGEAL Positive Professional Risperdal SS OROPHARINGEAL Cardiolipin Antibody Risperdal Consta SS INTRAMUSCULAR Leukopenia Risperdal SS OROPHARINGEAL Neutropenia Skenan Lp C Thrombocytopenia Dafalgan C Topalgic C Flaxiparine C Date:09/28/04ISR Number: 4461172-6Report Type:Expedited (15-DaCompany Report #PT-JNJFOC-20040903191 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Risperdal PS OROPHARINGEAL Initial or Prolonged Incontinence Infection Neuroleptic Malignant Syndrome Date:09/28/04ISR Number: 4461260-4Report Type:Expedited (15-DaCompany Report #CA-ABBOTT-04P-028-0271866-00 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Kaletra Soft Gelatin Drug Interaction Capsules PS ORAL 13 DAY Neuroleptic Malignant Zidovudine Syndrome W/Lamivudine C ORAL 13 DAY Pneumonia Aspiration Phenytoin Sodium C ORAL 14 DAY Sepsis Bactrim C ORAL 16 DAY Lorazepam C ORAL 15 DAY Zithromax C ORAL 16 DAY Risperdal I ORAL 6 DAY Risperdal I ORAL 6 DAY Date:09/28/04ISR Number: 4463003-7Report Type:Expedited (15-DaCompany Report #2004AP02335 Age:69 YR Gender:Male I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate Aminotransferase Increased Asthenia Azotaemia Blood Alkaline Phosphatase Increased Blood Lactate Dehydrogenase Increased Hepatic Function Abnormal Hypoglycaemia Hypotension Pneumonia Aspiration Protein Total Decreased Weight Decreased 22-Feb-2006 08:20 AM Page: 2286 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Decreased Report Source Product Role Manufacturer Route Dose Duration Foreign Seroquel PS ORAL 300 MG DAILY Health PO Professional Seroquel SS ORAL 200 MG DAILY Other PO Seroquel SS ORAL 100 MG DAILY PO Seroquel SS ORAL 50 MG DAILY PO Lodopin SS ORAL 100 MG DAILY PO Risperdal SS ORAL 3 MG DAILY PO Tasmolin SS ORAL 3 MG DAILY PO Tasmolin SS ORAL 2 MG DAILY PO Rohypnol SS ORAL 2 MG DAILY PO Vegetamin SS Zyprexa C Date:09/28/04ISR Number: 4463073-6Report Type:Expedited (15-DaCompany Report #2004AL000132 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Serax (Oxazepam) Initial or Prolonged Consciousness Health Tablets 25 Mg Professional (Alpharma) (Sera PS Alpharma ORAL PO Other Etidronate Disodium SS Fungizone SS ORAL PO Lasilix SS ORAL PO Neo Mercazole SS ORAL PO Risperdal SS ORAL 0.5 ML; QOD; PO Date:09/29/04ISR Number: 4461959-XReport Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040907351 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Herpes Simplex Risperdal Consta PS INTRAMUSCULAR 6 MON Impaired Healing Sodium Valproate C OROPHARINGEAL Lip Neoplasm Malignant Lamotrigine C OROPHARINGEAL Stage Unspecified Medication Error Date:09/29/04ISR Number: 4461960-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908211 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:09/29/04ISR Number: 4461961-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908213 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2287 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/04ISR Number: 4462263-6Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0343968A Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antinuclear Antibody Deroxat PS Glaxosmithkline ORAL 20MG Per day Initial or Prolonged Positive Risperdal SS ORAL 1MG Per day 19 MON Dermatitis Bullous Densical SS Glaxosmithkline ORAL 1UNIT Per day Immunology Test Abnormal Transipeg SS ORAL 2UNIT per day Pruritus Tiapridal C ORAL 5DROP per day Toxic Skin Eruption Date:09/30/04ISR Number: 4463136-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908644 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aphasia Risperdal PS OROPHARINGEAL Delirium Risperdal SS OROPHARINGEAL gradually Drug Interaction increased Excoriation from 1 mg per Neuroleptic Malignant day by day 10 Syndrome of hospital Pericardial Effusion Haldol SS OROPHARINGEAL dose taken at Pleural Effusion bedtime Rhabdomyolysis Risperdal SS OROPHARINGEAL White Blood Cell Count Benzotropine C Increased Date:09/30/04ISR Number: 4463174-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040906850 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Risperdal PS UNKNOWN Dyskinesia Professional Risperdal SS UNKNOWN Eating Disorder Quetiapine I OROPHARINGEAL Emotional Distress Paranoia Tremor Date:09/30/04ISR Number: 4463175-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908846 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Risperdal PS UNKNOWN Date:10/01/04ISR Number: 4464010-0Report Type:Expedited (15-DaCompany Report #AE-ABBOTT-04P-166-0274301-00 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Menorrhagia Depakine Chrono Tablets PS ORAL Depakine Chrono Tablets SS Risperidone SS ORAL 22-Feb-2006 08:20 AM Page: 2288 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/04ISR Number: 4464056-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040906297 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Risperdal PS OROPHARINGEAL Hospitalization - Grand Mal Convulsion Initial or Prolonged Date:10/01/04ISR Number: 4464057-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040906349 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Risperdal Consta PS INTRAMUSCULAR Hyperprolactinaemia Risperdal SS OROPHARINGEAL Hypothyroidism Weight Increased Date:10/01/04ISR Number: 4464058-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040906854 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Endometrial Cancer Risperdal PS OROPHARINGEAL Initial or Prolonged Other Date:10/01/04ISR Number: 4464059-8Report Type:Expedited (15-DaCompany Report #PL-JNJFOC-20040907374 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Health Rispolept PS OROPHARINGEAL Initial or Prolonged Renal Disorder Professional Suicide Attempt Date:10/01/04ISR Number: 4464060-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040907552 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal Consta PS INTRAMUSCULAR Decreased Date:10/01/04ISR Number: 4464061-6Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040907839 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Risperdal PS Date:10/01/04ISR Number: 4464062-8Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040908353 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intracranial Aneurysm Risperdal PS OROPHARINGEAL Hospitalization - Subarachnoid Haemorrhage Risperdal SS OROPHARINGEAL 1 mg in the Initial or Prolonged morning and 2 Disability mg at night Other 22-Feb-2006 08:20 AM Page: 2289 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/01/04ISR Number: 4464063-XReport Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040901978 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Risperdal PS OROPHARINGEAL White Blood Cell Count Fluvoxamine C OROPHARINGEAL Decreased Depot Provera C Date:10/01/04ISR Number: 4464064-1Report Type:Expedited (15-DaCompany Report #PT-JNJFOC-20040903191 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Health Risperdal PS OROPHARINGEAL Hospitalization - Syndrome Professional Artane C OROPHARINGEAL Initial or Prolonged Diazepam C OROPHARINGEAL 5 mg strength Date:10/01/04ISR Number: 4464065-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040808550 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Systolic Health Risperdal PS UNKNOWN Increased Professional Timolol C Cerebrovascular Accident Xalantan C Coma Trusopt C Syncope Aspirin C Weight Decreased Synthroid C Lasix C Cardizem Cd C Date:10/01/04ISR Number: 4464116-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908713 Age:8 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Haldol PS PARENTERAL Risperdal SS UNKNOWN Chlorpromazine SS UNKNOWN Date:10/01/04ISR Number: 4464281-0Report Type:Expedited (15-DaCompany Report #PHHO2004CA11926 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Clozaril PS Novartis Sector: Phosphokinase Increased Pharma ORAL 550 mg, QD 300 DAY Dehydration Risperdal SS Muscle Rigidity Valproic Acid C Neuroleptic Malignant Syndrome Tachycardia Date:10/04/04ISR Number: 4464699-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040807481 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drowning Risperdal PS OROPHARINGEAL Mental Impairment Risperdal SS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2290 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/04ISR Number: 4464700-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908679 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Phosphokinase Increased Paxil C OROPHARINGEAL Other Cognitive Deterioration Risperdal C OROPHARINGEAL Confusional State Date:10/04/04ISR Number: 4465295-7Report Type:Expedited (15-DaCompany Report #US-MERCK-0409USA01803 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compartment Syndrome Zocor PS Merck & Co., Inc ORAL Initial or Prolonged Drug Interaction Risperidone SS UNKNOWN Muscle Necrosis Clonazepam C UNKNOWN Rhabdomyolysis Date:10/04/04ISR Number: 4465444-0Report Type:Expedited (15-DaCompany Report #2004019017 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Overdose Health Quilonum Retard PS Glaxosmithkline ORAL 10TAB Single Suicide Attempt Professional dose Vomiting Aponal SS ORAL 110TAB Single dose Diclo SS Glaxosmithkline ORAL 10TAB Single dose Risperdal SS ORAL 10TAB Single dose Dogmatil SS ORAL 10CAP Single dose Cipramil SS ORAL 20TAB Single dose Dihydroergotoxine Mesylate SS ORAL 50TAB Single dose Date:10/04/04ISR Number: 4467029-9Report Type:Expedited (15-DaCompany Report #2004069541 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Hypersensitivity Consumer Geodon (Ziprasidone) PS Initial or Prolonged Risperidone (Risperidone) SS Sertraline Hydrochloride (Sertraline Hydrochloride) C Date:10/05/04ISR Number: 4466183-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908242 Age:44 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Fentanyl PS OROPHARINGEAL Multiple Drug Overdose Risperidone SS OROPHARINGEAL Clonazepam SS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2291 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/04ISR Number: 4466227-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040909365 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Risperdal PS OROPHARINGEAL Depakote C Trazodone C Lamictal C Date:10/05/04ISR Number: 4466228-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20040909386 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Risperdal PS OROPHARINGEAL 6 MON Initial or Prolonged Overdose Asa C Sepsis Date:10/05/04ISR Number: 4466229-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040909396 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Risperdal PS OROPHARINGEAL Heart Rate Decreased Risperdal SS OROPHARINGEAL Medication Error Trazodone C OROPHARINGEAL taken at Somnolence night Date:10/05/04ISR Number: 4466230-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040909752 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pyrexia Risperdal PS OROPHARINGEAL Etizolam C OROPHARINGEAL Date:10/05/04ISR Number: 4466231-XReport Type:Expedited (15-DaCompany Report #IE-JNJFOC-20040909781 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Risperdal Consta PS INTRAMUSCULAR Liver Function Test Risperdal Consta SS INTRAMUSCULAR Abnormal Thyroid Function Test Abnormal Date:10/05/04ISR Number: 4466232-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041000070 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal PS OROPHARINGEAL Decreased Date:10/05/04ISR Number: 4466233-3Report Type:Expedited (15-DaCompany Report #PL-JNJFOC-20040907374 Age:14 YR Gender:Female I/FU:I Outcome PT Hospitalization - Extrapyramidal Disorder Initial or Prolonged Overdose 22-Feb-2006 08:20 AM Page: 2292 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Disorder Report Source Product Role Manufacturer Route Dose Duration Rispolept PS OROPHARINGEAL Date:10/05/04ISR Number: 4469489-6Report Type:Direct Company Report #CTU 228847 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abdominal Discomfort Risperdal 3 Mg Required Abdominal Hernia Janssen PS Janssen ORAL 3 MG TWICE Intervention to Benign Pancreatic DAILY ORAL Prevent Permanent Neoplasm Impairment/Damage Date:10/06/04ISR Number: 4466876-7Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040910153 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS OROPHARINGEAL White Blood Cell Count Decreased Date:10/06/04ISR Number: 4466877-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040910182 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hair Metal Test Abnormal Risperdal PS OROPHARINGEAL Date:10/06/04ISR Number: 4466878-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041000263 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akinesia Risperdal PS OROPHARINGEAL Cardiac Pacemaker Depakote C OROPHARINGEAL Insertion Convulsion Depressed Level Of Consciousness Dysarthria Dyskinesia Incontinence Oppositional Defiant Disorder Social Avoidant Behaviour Tic Date:10/06/04ISR Number: 4466879-2Report Type:Periodic Company Report #US-JNJFOC-20040707301 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal PS OROPHARINGEAL Professional 22-Feb-2006 08:20 AM Page: 2293 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/04ISR Number: 4467261-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908242 Age:44 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Duragesic PS OROPHARINGEAL Intentional Risperidone SS OROPHARINGEAL Clonazepam SS OROPHARINGEAL Date:10/07/04ISR Number: 4467956-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040903190 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Risperdal PS OROPHARINGEAL Glaucoma Date:10/07/04ISR Number: 4467957-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040900961 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Health Risperdal PS OROPHARINGEAL Initial or Prolonged Alanine Aminotransferase Professional Haldol SS OROPHARINGEAL 1 DAY Increased Tercian C UNKNOWN dose=tablet Blood Creatine Levomepromazine C Phosphokinase Increased Rivotril C INTRAMUSCULAR Rhabdomyolysis Tranxene C INTRAMUSCULAR Valium C Date:10/07/04ISR Number: 4467958-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040808811 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Injury Health Risperdal PS OROPHARINGEAL Initial or Prolonged Road Traffic Accident Professional Skeletal Injury Date:10/07/04ISR Number: 4473141-0Report Type:Direct Company Report #USP 56907 Age:96 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Risperdal PS Janssen ORAL SOLUTION Date:10/08/04ISR Number: 4469474-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040701514 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anticholinergic Syndrome Risperdal PS OROPHARINGEAL Hospitalization - Hepatic Failure Paroxetin C OROPHARINGEAL 1 WK Initial or Prolonged Loss Of Consciousness Tavor C OROPHARINGEAL Other Renal Failure Acute Rhabdomyolysis 22-Feb-2006 08:20 AM Page: 2294 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/04ISR Number: 4469476-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040909788 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Colonic Risperdal PS OROPHARINGEAL Pseudo-Obstruction Tercian SS OROPHARINGEAL Drug Interaction Tercian SS OROPHARINGEAL Gastrointestinal Necrosis Lysanxia C Megacolon Oxygen Saturation Decreased Septic Shock Volvulus Of Bowel Date:10/08/04ISR Number: 4469477-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040910003 Age:3 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Risperdal PS OROPHARINGEAL Initial or Prolonged Medication Error Date:10/08/04ISR Number: 4469478-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041000035 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Risperdal PS OROPHARINGEAL Initial or Prolonged Dysphagia Professional Dicetel SS OROPHARINGEAL Medication Error Exelon SS OROPHARINGEAL Mouth Ulceration Diffu-K SS OROPHARINGEAL Hytacand C Hytacand C Amlor C Pariet C Motilium C Doliprane C Insulines Umuline Nph C Fraxiparine C Date:10/08/04ISR Number: 4469479-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041001028 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal PS OROPHARINGEAL Risperdal SS OROPHARINGEAL Date:10/08/04ISR Number: 4469480-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041001031 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Test Risperdal PS OROPHARINGEAL Drug Interaction Quetiapine Fumarate SS OROPHARINGEAL Drug Screen Positive Zotepine SS OROPHARINGEAL Murder Etizolam SS OROPHARINGEAL Suicide Attempt Rilmazafone Hydrochloride SS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2295 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/04ISR Number: 4469481-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20031200253 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Distension Risperdal PS OROPHARINGEAL Asthma Risperdal Consta SS Chest Pain Calcium D C Condition Aggravated Calcium D C Cushingoid Calcium D C Depression Kepra C Fall Zonegran C Gastrooesophageal Reflux Synthroid C Disease Allegra C Head Injury Protonix C Insomnia Ativan C Joint Swelling Advair Diskus C Loss Of Consciousness Advair Diskus C Myalgia Ketoconazole C Oedema Peripheral Desonide C Restlessness Clobetasol C Status Epilepticus Felbamate C Syncope Trileptal C Weight Increased Vitamin E C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Claritin C Date:10/08/04ISR Number: 4469483-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040909752 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pyrexia Risperdal PS OROPHARINGEAL Etizolam C OROPHARINGEAL Date:10/08/04ISR Number: 4473875-8Report Type:Direct Company Report #CTU 229120 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Risperdal PS 3 MG HS Decreased Date:10/08/04ISR Number: 4474214-9Report Type:Expedited (15-DaCompany Report #S04-CAN-06399-01 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Foreign Memantine PS ORAL 10 MG BID PO Health Reminyl /Usa/ Professional (Galantamine Other Hydrobromide) SS ORAL 24 MG QD PO Risperdal (Risperidone) SS ORAL 0.25 MG QD PO Imovane (Zopiclone) C 22-Feb-2006 08:20 AM Page: 2296 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/11/04ISR Number: 4470844-9Report Type:Expedited (15-DaCompany Report #PHBS2004JP11891 Age:33 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pain Health Ritaline PS Novartis Sector: Priapism Professional Pharma ORAL Tegretol SS ORAL Akineton SS ORAL Erimin SS ORAL Wintermin SS ORAL Risperdal SS ORAL Depas SS ORAL Myslee SS ORAL Serenzin SS Date:10/11/04ISR Number: 4470861-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041000039 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Risperdal PS OROPHARINGEAL Initial or Prolonged Infection Risperdal SS OROPHARINGEAL Tercian C Athymil C Seresta C Depakote C Date:10/11/04ISR Number: 4470862-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041000042 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dehydration Risperdal PS OROPHARINGEAL Extrapyramidal Disorder Risperdal SS OROPHARINGEAL Haemoconcentration Aldactazine C Hypernatraemia Aldactazine C Renal Failure Mogadon C Renal Failure Acute Tercian C Respiratory Arrest Lasilix C Somnolence Tranxene C White Blood Cell Count Increased Date:10/11/04ISR Number: 4470863-2Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20041000044 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Head Injury Risperdal SS OROPHARINGEAL Date:10/11/04ISR Number: 4470864-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041000194 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Health Risperdal PS OROPHARINGEAL Granulocytopenia Professional Risperdal SS OROPHARINGEAL Hypersensitivity Topamax SS OROPHARINGEAL Cipramil SS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2297 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/11/04ISR Number: 4470865-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041000543 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blepharospasm Risperdal PS Weight Increased Date:10/11/04ISR Number: 4470866-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040907552 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal Consta PS INTRAMUSCULAR Professional Date:10/12/04ISR Number: 4471624-0Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20041000529 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperdal Consta PS INTRAMUSCULAR Concor C OROPHARINGEAL Akineton C OROPHARINGEAL Date:10/12/04ISR Number: 4471625-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041000553 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Haemorrhagic Health Risperdal PS OROPHARINGEAL Life-Threatening Pancreatitis Necrotising Professional Lofepramine SS OROPHARINGEAL Senna C OROPHARINGEAL Date:10/12/04ISR Number: 4471626-4Report Type:Expedited (15-DaCompany Report #CZ-JNJFOC-20041000763 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Risperdal Consta PS INTRAMUSCULAR Drug Exposure During Pregnancy Ectopic Pregnancy Date:10/12/04ISR Number: 4471627-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041002856 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal PS OROPHARINGEAL Oligomenorrhoea Date:10/12/04ISR Number: 4472771-XReport Type:Direct Company Report #CTU 229433 Age:28 YR Gender:Male I/FU:I Outcome PT Disability Abnormal Behaviour Required Affect Lability Intervention to Aggression Prevent Permanent Agitation Impairment/Damage Amnesia Aphasia 22-Feb-2006 08:20 AM Page: 2298 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Arrhythmia Cognitive Disorder Depression Report Source Product Role Manufacturer Route Dose Duration Disturbance In Attention Risperdal 1mg/.5mg Dysgraphia Janssen PS Janssen ORAL 1MG/.5MG ONCE Dyskinesia A DAY ORAL Extraocular Muscle Zoloft Pfizer SS Pfizer ORAL ONCE A DAY Paresis ORAL Facial Palsy Feeling Abnormal Feeling Jittery Hallucination Hostility Hypoaesthesia Insomnia Irritability Libido Decreased Memory Impairment Mood Swings Muscle Disorder Muscle Twitching Palpitations Personality Change Psychotic Disorder Tardive Dyskinesia Thinking Abnormal Tic Transient Ischaemic Attack Date:10/12/04ISR Number: 4474864-XReport Type:Expedited (15-DaCompany Report #2004066070 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Foreign Sulperazon Initial or Prolonged Depressed Level Of Health (Cefoperazone, Consciousness Professional Sulbactam) PS INTRAVENOUS 4 GRAM (2 Hypocalcaemia Company GRAM, 2 IN 1 Hyponatraemia Representative D), INTRAVENOUS Risperidone (Risperidone) SS ORAL 1 MG (1 MG, 1 IN 1 D), ORAL Clarithromycin (Clarithromycin) C Famotidine (Famotidine) C Date:10/13/04ISR Number: 4472907-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041001503 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Pancreatic Risperdal PS OROPHARINGEAL Neoplasm 22-Feb-2006 08:20 AM Page: 2299 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/04ISR Number: 4472908-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041002681 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Health Risperdal Consta PS INTRAMUSCULAR (25mg and Breast Cancer Male Professional 50mg injections) Risperdal SS Date:10/13/04ISR Number: 4472909-4Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040501168 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Health Risperidone PS OROPHARINGEAL stopped for a Initial or Prolonged Csf Pressure Increased Professional few days for Other Headache dechallenge Hypomania Risperidone SS OROPHARINGEAL Hypothyroidism Lithium Carbonate SS OROPHARINGEAL Intervertebral Disc Risperidone SS OROPHARINGEAL re-started Disorder after Intracranial Pressure dechallenge Increased Antitriptyline C OROPHARINGEAL Major Depression Metformin C OROPHARINGEAL Papilloedema Retinal Haemorrhage Therapy Non-Responder Date:10/13/04ISR Number: 4472910-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20031201568 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Health Risperdal PS OROPHARINGEAL Hospitalization - Pulmonary Embolism Professional Haloperidol SS OROPHARINGEAL Initial or Prolonged Venous Thrombosis Zotepine SS OROPHARINGEAL Levomepromazine Maleate SS OROPHARINGEAL Carbamazepine C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Bromazepam C OROPHARINGEAL Teprenone C OROPHARINGEAL Gentian C OROPHARINGEAL Sodium Bicarbonate C OROPHARINGEAL Date:10/13/04ISR Number: 4472911-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040604288 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Health Risperdal PS OROPHARINGEAL Congestive Professional Pneumonia Date:10/13/04ISR Number: 4473020-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040803674 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Health Risperdal PS OROPHARINGEAL Professional Risperdal SS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2300 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoloft C OROPHARINGEAL Trazodone C OROPHARINGEAL Date:10/14/04ISR Number: 4474407-0Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040908353 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebral Thrombosis Health Risperdal PS OROPHARINGEAL Hospitalization - Hemiplegia Professional Risperdal SS OROPHARINGEAL Initial or Prolonged Intracranial Aneurysm Risperdal SS OROPHARINGEAL 1 mg in the Disability Loss Of Consciousness morning and 2 Other Neurologic Neglect mg at night Syndrome Clonazepam C Subarachnoid Haemorrhage Loxapine C Imovane C Date:10/14/04ISR Number: 4474417-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041002698 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Congestive Date:10/15/04ISR Number: 4475205-4Report Type:Periodic Company Report #FR-JNJFOC-20040602725 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Risperdal PS OROPHARINGEAL Initial or Prolonged Syndrome Loxapac SS Theralene SS OROPHARINGEAL Loxapac SS INTRAMUSCULAR Temesta C 1 mg and 2.5 mg Stilnox C Date:10/15/04ISR Number: 4475260-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041000740 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adverse Event Risperdal PS OROPHARINGEAL Initial or Prolonged Ergenyl Chrono SS OROPHARINGEAL Ergenyl Chrono SS OROPHARINGEAL Date:10/15/04ISR Number: 4475261-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041002835 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Respiratory Failure Resperdal PS OROPHARINGEAL 53 DAY Pneumonia Chlorpromazine Hibenzate C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2301 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/04ISR Number: 4475262-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041001031 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Risperdal PS OROPHARINGEAL Drug Interaction Professional Quetiapine Fumarate SS OROPHARINGEAL Overdose Zotepine SS OROPHARINGEAL Victim Of Crime Etizolam C OROPHARINGEAL Rilmazafone Hydrochloride C OROPHARINGEAL Date:10/15/04ISR Number: 4475414-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040906841 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anal Fissure Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Constipation Risperdal Consta SS INTRAMUSCULAR Date:10/15/04ISR Number: 4475415-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040602726 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Consumer Risperdal PS OROPHARINGEAL Initial or Prolonged Blood Pressure Risperdal SS OROPHARINGEAL Disability Fluctuation Risperdal SS OROPHARINGEAL Other Confusional State Risperdal SS OROPHARINGEAL Faecal Incontinence Feeling Drunk Flushing Hallucination Hallucination, Visual Hyperhidrosis Muscle Rigidity Retinal Scar Urinary Incontinence Verbal Abuse Visual Disturbance Weight Increased Date:10/15/04ISR Number: 4475475-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041002834 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Health Risperdal PS OROPHARINGEAL Initial or Prolonged Increased Professional Chlorpromazine Pneumatosis Intestinalis Hydrochloride SS OROPHARINGEAL White Blood Cell Count Levomepromazine Increased Maleate SS OROPHARINGEAL Date:10/15/04ISR Number: 4475476-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040606157 Age: Gender:Male I/FU:I Outcome PT Other Convulsion Depressed Level Of Consciousness Hypokalaemia Inappropriate 22-Feb-2006 08:20 AM Page: 2302 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Antidiuretic Hormone Secretion Rhabdomyolysis Report Source Product Role Manufacturer Route Dose Duration Health Risperdal PS OROPHARINGEAL Professional Biperiden Hydrochloride C Date:10/15/04ISR Number: 4476633-3Report Type:Direct Company Report #CTU 229695 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Psychosis Venlafaxine PS ORAL ORAL Initial or Prolonged Dystonia Risperdal SS ORAL ORAL Insomnia Mental Status Changes Tachycardia Date:10/15/04ISR Number: 4479256-5Report Type:Expedited (15-DaCompany Report #2004235933US Age:33 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Xanax (Alprazolam) Multiple Drug Overdose Health Tablet PS ORAL ORAL Intentional Professional Sequinan (Risperidone) Tablet SS ORAL ORAL Tranylcypromine (Tranylcypromine) SS ORAL ORAL Date:10/15/04ISR Number: 4479324-8Report Type:Expedited (15-DaCompany Report #2004236077US Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Xanax (Alprazolam) Completed Suicide Health Tablet PS Intentional Overdose Professional Sequinan (Risperidone) Tablet SS Citalopram (Citalopram) SS Date:10/15/04ISR Number: 4479329-7Report Type:Expedited (15-DaCompany Report #2004235654US Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Metiguanide(Metformi Multiple Drug Overdose Health n Hydrochloride) Intentional Professional Tablet PS ORAL ORAL Glynase Prestab ( Glyburide) Tablet, 1.5-6 Mg SS ORAL ORAL Sertraline (Sertraline Hydrochloride) Capsule SS ORAL ORAL Sequinan (Risperidone) Solution SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 2303 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/15/04ISR Number: 4479400-XReport Type:Expedited (15-DaCompany Report #2004236853US Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Trombyl Hyperventilation Health (Acetylsalicylic Hypotension Professional Acid) Tablet PS ORAL ORAL Mental Status Changes Glynase Prestab Multiple Drug Overdose (Glyburide) Tablet, Oliguria 1.5-6mg SS Respiratory Rate Metiguanide Decreased (Metformin Hydrochloride) Tablet SS Risperidone (Risperidone) SS Date:10/18/04ISR Number: 4476990-8Report Type:Expedited (15-DaCompany Report #ES-ABBOTT-04P-144-0276850-00 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Akineton PS ORAL Suicide Attempt Rhodogil C ORAL 5 DAY Clorazepate Dipotassium C Olanzapine C Valpromide I ORAL Trazodone Hydrochloride I ORAL Risperdal Consta I ORAL 132 DAY Vantral Retard I ORAL 92 DAY Date:10/18/04ISR Number: 4477117-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041002799 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Risperdal PS OROPHARINGEAL Date:10/18/04ISR Number: 4477231-8Report Type:Expedited (15-DaCompany Report #CZ-JNJFOC-20041002425 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Risperdal Consta PS INTRAMUSCULAR treatment Completed Suicide ongoing at Overdose time of event Risperdal SS treatment ongoing at time of event Alprazolam SS OROPHARINGEAL Alprazolam SS OROPHARINGEAL 0.5 up to 1mg daily therapy ongoing at time of event Tisercin C dose taken as needed for insomnia 22-Feb-2006 08:20 AM Page: 2304 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/04ISR Number: 4477232-XReport Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040901978 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Health Risperdal PS OROPHARINGEAL White Blood Cell Count Professional Fluvoxamine C OROPHARINGEAL Decreased Depot Provera C Date:10/18/04ISR Number: 4477233-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040900526 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Health Risperdal PS UNKNOWN Professional Escitalopram C Date:10/18/04ISR Number: 4478473-8Report Type:Direct Company Report #CTU 229803 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anger Paxil PS Completed Suicide Effexor SS Injury Asphyxiation Resperidal SS Date:10/19/04ISR Number: 4478427-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041002967 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Risperdal PS Date:10/19/04ISR Number: 4478428-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041003514 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal Consta PS INTRAMUSCULAR Multiple Medications C Date:10/19/04ISR Number: 4478429-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041003702 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Female Risperdal PS OROPHARINGEAL Zoloft C Date:10/19/04ISR Number: 4478430-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041003717 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Risperdal PS OROPHARINGEAL Prolonged Strattera C 22-Feb-2006 08:20 AM Page: 2305 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/04ISR Number: 4478431-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040902803 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Risperdal PS OROPHARINGEAL Initial or Prolonged Leukopenia Professional Tercian SS OROPHARINGEAL Lymphopenia Neutropenia Date:10/19/04ISR Number: 4478432-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040810131 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Health Risperdal PS OROPHARINGEAL Eosinophil Percentage Professional Biperiden Decreased Hydrochloride C OROPHARINGEAL Mean Cell Haemoglobin Alprazolam C OROPHARINGEAL Increased Flunitrazepam C OROPHARINGEAL Psychiatric Symptom Zonisamide C OROPHARINGEAL Zinc Sulphate Turbidity Levomepromazine Decreased Maleate C OROPHARINGEAL Magnesium Oxide C OROPHARINGEAL Date:10/19/04ISR Number: 4478552-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041002864 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arteritis Risperdal PS OROPHARINGEAL Initial or Prolonged Blood Pressure Topalgic SS OROPHARINGEAL Orthostatic Increased Topalgic SS OROPHARINGEAL Disorientation Tegretol SS OROPHARINGEAL Localised Infection Fonzylane SS OROPHARINGEAL Orthostatic Hypotension Cozaar SS OROPHARINGEAL Pain Sepsis Syncope Vasovagal Date:10/19/04ISR Number: 4480533-2Report Type:Expedited (15-DaCompany Report #2004075203 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Foreign Neurontin Other Thrombophlebitis Pelvic Health (Gabapentin) PS ORAL 600 MG (300 Vein Professional MG, 2 IN 1 D), ORAL Risperidone (Risperidone) SS ORAL 5 MG (1 D), ORAL Diazepam SS ORAL 40 DROP (20 DROP 2 IN 1D)ORAL Hydromorphone Hydrochloride SS ORAL 2 MG , 2 IN I DAY, ORAL 22-Feb-2006 08:20 AM Page: 2306 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/04ISR Number: 4479339-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040900514 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dermatitis Bullous Health Risperdal PS OROPHARINGEAL Initial or Prolonged Pemphigoid Professional Calcium Carbonate SS OROPHARINGEAL Pruritus Deroxat SS Skin Ulcer Transipeg SS OROPHARINGEAL 2 sachets per Toxic Skin Eruption day Date:10/20/04ISR Number: 4479740-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041004888 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Ruptured Risperdal Consta PS INTRAMUSCULAR Risperdal SS OROPHARINGEAL Spironolactone C Seroquil C Date:10/20/04ISR Number: 4479741-6Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040908353 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebral Thrombosis Health Risperdal PS OROPHARINGEAL Hospitalization - Hemiplegia Professional Risperdal SS OROPHARINGEAL Initial or Prolonged Loss Of Consciousness Risperdal SS OROPHARINGEAL 1 mg in the Disability Ruptured Cerebral morning and 2 Other Aneurysm mg at night Subarachnoid Haemorrhage Clonazepam C Loxapine C Imovane C Date:10/20/04ISR Number: 4480207-8Report Type:Expedited (15-DaCompany Report #PHRM2004FR03094 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Right Tegretol PS Novartis Sector: Initial or Prolonged Disorientation Pharma ORAL UNK, UNK Orthostatic Hypotension Topalgic SS ORAL 1 DF, BID Syncope Vasovagal Fonzylane SS ORAL Cozaar SS ORAL 50 mg, QD Risperdal SS ORAL Date:10/21/04ISR Number: 4481048-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041004735 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Risperdal PS OROPHARINGEAL Other Phosphokinase Increased Pyrexia Date:10/21/04ISR Number: 4481049-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20041005281 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS OROPHARINGEAL Concerta C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2307 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/04ISR Number: 4481191-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041003531 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Risperdal PS OROPHARINGEAL Initial or Prolonged Miosis Sedation Date:10/21/04ISR Number: 4481192-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041003542 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Risperdal PS OROPHARINGEAL Hospitalization - Increased Olanzapine C OROPHARINGEAL Initial or Prolonged Serotonin Syndrome Fluoxetine C OROPHARINGEAL Chlorpromazine C OROPHARINGEAL Diazepam C OROPHARINGEAL Dose: 10 mg OD PRN Date:10/21/04ISR Number: 4481193-7Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20041004288 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Fibrillation Risperdal PS OROPHARINGEAL 45 DAY Date:10/21/04ISR Number: 4481194-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040802463 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Extrapyramidal Disorder Health Risperdal Consta PS INTRAMUSCULAR Hospitalization - Respiratory Failure Professional Risperdal Consta SS INTRAMUSCULAR Initial or Prolonged Risperdal SS OROPHARINGEAL Other Haldol SS OROPHARINGEAL Tavor SS OROPHARINGEAL Norvasc C OROPHARINGEAL Date:10/21/04ISR Number: 4481195-0Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20041000044 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Head Injury Risperdal SS OROPHARINGEAL Ditropan C OROPHARINGEAL Fludex C OROPHARINGEAL Moxon C OROPHARINGEAL Date:10/22/04ISR Number: 4482410-XReport Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12648408 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Dystonia Buspar Tabs PS Bristol-Myers Squibb Tardive Dyskinesia Company ORAL dose repeatedly changed until 06-Dec-01, when Risperdal SS 22-Feb-2006 08:20 AM Page: 2308 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/22/04ISR Number: 4482511-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041005849 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Health Risperdal PS Initial or Prolonged Dysuria Professional Extrapyramidal Disorder Obsessive-Compulsive Disorder Date:10/22/04ISR Number: 4482610-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041003296 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Risperdal PS OROPHARINGEAL Initial or Prolonged Dehydration Haldol Decanoas SS INTRAMUSCULAR Disorientation Depamide C Haemoglobin Decreased Lepticur C Hyponatraemia Micturition Disorder Thirst Weight Increased Date:10/22/04ISR Number: 4484683-6Report Type:Expedited (15-DaCompany Report #2004AL000806 Age:33 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Alprazolam Tablets Multiple Drug Overdose Usp, 0.25mg, 0.5mg, 1mg, And 2mg (Purepac) PS Purepac ORAL PO Risperidone SS ORAL PO Tranylcypromine SS Date:10/22/04ISR Number: 4484734-9Report Type:Expedited (15-DaCompany Report #2004AL000697 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Alprazolam Tablets Completed Suicide Usp, Multiple Drug Overdose 0.25mg,0.25mg,1mg,An d 2mg (Purepac) PS ORAL PO Citalopram SS ORAL PO Resperidone SS ORAL PO Date:10/22/04ISR Number: 4484748-9Report Type:Expedited (15-DaCompany Report #2004AL000513 Age:44 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Misuse Literature Clonazepam Tablets Multiple Drug Overdose Usp, 0.5mg,1mg And 2mg (Purepac) PS Purepac ORAL PO Fentanyl SS ORAL PO Risperidone SS 22-Feb-2006 08:20 AM Page: 2309 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/22/04ISR Number: 4486826-7Report Type:Expedited (15-DaCompany Report #2004BL007056 Age:44 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Abuser Literature Albuterol Sulfate Intentional Misuse Health Inhalation Solution Professional 0.5% PS Fentanyl SS ORAL ORAL Clonazepam SS ORAL ORAL Risperidone SS ORAL ORAL Date:10/25/04ISR Number: 4483863-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040903213 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Clonic Convulsion Risperdal PS OROPHARINGEAL Hospitalization - Respiratory Failure Risperdal SS OROPHARINGEAL Initial or Prolonged Sedation Clozapine C Paroxetine C Lorazepam C Tropatepine C Date:10/25/04ISR Number: 4483864-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041003996 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Risperdal PS OROPHARINGEAL Delusion Aspirin C UNKNOWN Drug Ineffective Calcichew C UNKNOWN Date:10/25/04ISR Number: 4483865-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041004498 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infarction Risperdal PS OROPHARINGEAL Date:10/25/04ISR Number: 4483866-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041004877 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Risperdal PS OROPHARINGEAL Initial or Prolonged Acc C UNKNOWN Date:10/25/04ISR Number: 4483867-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041004921 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pericarditis Risperdal PS OROPHARINGEAL Initial or Prolonged Pleurisy Nozinan C UNKNOWN Pleuropericarditis Theralene C UNKNOWN Lysanxia C Adepal C Adepal C Aldactone C 22-Feb-2006 08:20 AM Page: 2310 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/04ISR Number: 4484269-3Report Type:Expedited (15-DaCompany Report #2004019017 Age:54 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Quilonum Retard PS Glaxosmithkline ORAL 10TAB Single Initial or Prolonged Intentional Overdose dose Suicide Attempt Aponal SS ORAL 110TAB Single Vomiting dose Diclo SS Glaxosmithkline ORAL 10TAB Single dose Risperdal SS ORAL 10TAB Single dose Dogmatil SS ORAL 10CAP Single dose Cipramil SS ORAL 20TAB Single dose Dihydroergotoxine Mesylate SS ORAL 50TAB Single dose Date:10/25/04ISR Number: 4487834-2Report Type:Expedited (15-DaCompany Report #S04-FRA-00774-01 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nervousness Foreign Seropram (Citalopram Initial or Prolonged Parkinson'S Disease Health Hydrobromide) PS Professional Seropram (Citaloparm Other Hydrobromide) SS ORAL 20 MG QD PO Risperdal (Risperidone) SS ORAL 1 MG QD PO Sedative Neuroleptic (Nos) C Lysnaxia (Prazepam) C Equanil (Meprobamate) C Hept-A-Myl (Heptaminol Hydrochloride) C Zopiclone C Zoxan (Doxazosin Mesilate) C Date:10/26/04ISR Number: 4485513-9Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12741559 Age:40 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Glyburide + Intentional Overdose Metformin Hcl PS Bristol-Myers Squibb Multiple Drug Overdose Company ORAL Intentional Sertraline SS ORAL Risperidone SS ORAL Date:10/26/04ISR Number: 4485598-XReport Type:Expedited (15-DaCompany Report #ES-JNJFOC-20041005226 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Health Risperdal PS OROPHARINGEAL Syndrome Professional Ameride C OROPHARINGEAL Ameride C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2311 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Combivent C RESPIRATORY (INHALATION) Seretide C RESPIRATORY (INHALATION) Rohypnol C OROPHARINGEAL Seretide C RESPIRATORY (INHALATION) Combivent C RESPIRATORY (INHALATION) Sinogan I OROPHARINGEAL Date:10/26/04ISR Number: 4485599-1Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20041005227 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Risperdal Consta PS INTRAMUSCULAR Drug Interaction Professional Rhodolgyl C OROPHARINGEAL Tranxilium C Zyprexa C OROPHARINGEAL Vandral Retard I Depamide I OROPHARINGEAL Akineton Retard I OROPHARINGEAL Deprax I OROPHARINGEAL Date:10/26/04ISR Number: 4485600-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041006580 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Nervosa Risperdal PS OROPHARINGEAL Hospitalization - Chest Pain Initial or Prolonged Dehydration Renal Cell Carcinoma Stage Unspecified Weight Decreased Date:10/26/04ISR Number: 4485601-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20040103245 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Asthenia Risperdal Consta SS INTRAMUSCULAR Other Blood Prolactin Increased Haloperidol SS OROPHARINGEAL Condition Aggravated Proneurin C OROPHARINGEAL at night Decreased Interest Proneurin C OROPHARINGEAL "changed to Drug Interaction 0-0-1-2" Fatigue Proneurin C OROPHARINGEAL Injury Proneurin C OROPHARINGEAL Menstruation Irregular Proneurin C OROPHARINGEAL taken at Psychotic Disorder night Refusal Of Treatment By Amitriptylin C OROPHARINGEAL 4x1 Patient Amitriptylin C OROPHARINGEAL switched to Suicide Attempt promethazine Biperiden C Biperiden C Lorazepam C Radedorm C Stilnox C "0-0-1" 22-Feb-2006 08:20 AM Page: 2312 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/26/04ISR Number: 4485610-8Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20041001085 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Topamax PS Risperdal Consta SS Trileptal C UNKNOWN Clorazepate C Date:10/26/04ISR Number: 4488209-2Report Type:Expedited (15-DaCompany Report #2004077508 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Geodon Ziprasidone) PS 80 MG Syndrome Professional Risperidone Company (Risperidone) SS 1 MG Representative Date:10/26/04ISR Number: 4489292-0Report Type:Expedited (15-DaCompany Report #MESA-2004-008 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Pulmonary Oedema Foreign Salofolk Hospitalization - Agranulocytosis Health (Mesalamine) PS ORAL 500 MG 2 Initial or Prolonged Cardiogenic Shock Professional TABLETS QID Delirium Other PO Infection Risperdal SS Myocardial Infarction Synthyroid C Neutropenia Cortenema Pyrexia (Hydrocortisone) C Hydrochlorothiazide C Desyrel (Trazodone Hcl) C Aspirin C Iraxure C Nitroglycerine Isosorbide) C Monocor (Bisoprolol Fumerate) C Imdur (Isosorbide 5-Mononitrate) C Lovastatin C Ferrous Sulfate C Date:10/27/04ISR Number: 4487621-5Report Type:Direct Company Report #CTU 230625 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Risperidone 4 Mg PS ORAL 4 MG QD ORAL Initial or Prolonged Blood Glucose Increased Quetiapine 200mg SS ORAL 400 MG QHS Required Nausea ORAL Intervention to Weight Increased Prevent Permanent Impairment/Damage 22-Feb-2006 08:20 AM Page: 2313 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/04ISR Number: 4487800-7Report Type:Direct Company Report #CTU 230525 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Risperidal 2 Mg - Jenson PS Jenson 2 MG Date:10/28/04ISR Number: 4488160-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041007423 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Risperdal PS OROPHARINGEAL Increased Cogentin C OROPHARINGEAL Hypercholesterolaemia Benadryl C OROPHARINGEAL dose taken at night Paxil Cr C OROPHARINGEAL Date:10/28/04ISR Number: 4488161-XReport Type:Expedited (15-DaCompany Report #EMADSS2003003813 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abasia Health Risperdal PS UNKNOWN 6 DAY Cold Sweat Professional Risperdal SS UNKNOWN 6 DAY Neuroleptic Malignant Oxazepamum C OROPHARINGEAL Syndrome Furosemide C Pain In Extremity Date:10/28/04ISR Number: 4488162-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041004735 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Risperdal PS OROPHARINGEAL Other Phosphokinase Increased Catatonia Neuroleptic Malignant Syndrome Pyrexia Date:10/28/04ISR Number: 4488164-5Report Type:Expedited (15-DaCompany Report #EMADSS2003003405 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anxiety Health Risperdal PS OROPHARINGEAL 53 DAY Difficulty In Walking Professional Risperdal SS OROPHARINGEAL 53 DAY Drug Interaction Risperdal SS OROPHARINGEAL 53 DAY Erythema Seresta C UNKNOWN Feeling Abnormal Seresta C UNKNOWN General Physical Health Seresta C UNKNOWN Deterioration Doxycyclinum I UNKNOWN 1 WK Neuroleptic Malignant Syndrome Pain In Extremity Prolonged Expiration Stridor 22-Feb-2006 08:20 AM Page: 2314 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/29/04ISR Number: 4489193-8Report Type:Expedited (15-DaCompany Report #CZ-JNJFOC-20041002425 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Risperdal Consta PS INTRAMUSCULAR treatment Drug Toxicity ongoing at time of event Risperdal SS treatment ongoing at time of event Alprazolam SS OROPHARINGEAL Alprazolam SS OROPHARINGEAL 0.5 up to 1mg daily therapy ongoing at time of event Tisercin C dose taken as needed for insomnia Date:10/29/04ISR Number: 4489194-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041006527 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Risperdal PS OROPHARINGEAL Initial or Prolonged Arachnoid Cyst Risperdal SS OROPHARINGEAL Brain Scan Abnormal Seloken 100 C Cytolytic Hepatitis Amlor C Dysarthria Vasten C Electroencephalogram Lanzor C Abnormal Ebixa C Extrapyramidal Disorder Hypertonia Parkinson'S Disease Tremor Date:10/29/04ISR Number: 4489195-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041006534 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal PS OROPHARINGEAL 0.75-0-0.5 Gynaecomastia Risperdal SS OROPHARINGEAL Precocious Puberty Date:10/29/04ISR Number: 4489196-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041006540 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Risperdal PS OROPHARINGEAL Hypothyroidism Loss Of Libido Date:10/29/04ISR Number: 4489197-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040706065 Age: Gender:Female I/FU:I Outcome PT Other Antinuclear Antibody Positive 22-Feb-2006 08:20 AM Page: 2315 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cardiolipin Antibody Neutropenia Thrombocytopenia Report Source Product Role Manufacturer Route Dose Duration Risperdal PS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal Consta SS INTRAMUSCULAR Risperdal SS OROPHARINGEAL Skenan Lp C Dafalgan C Topalgic C Flaxiparine C Date:10/29/04ISR Number: 4489198-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20030902734 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Risperdal PS Initial or Prolonged Brain Malformation Lysanxia SS Congenital Anomaly Cerebral Atrophy Clopixol SS Developmental Lepticur C Coordination Disorder Orocal C INTRA-UTERINE Drug Exposure During Tardyferon C INTRA-UTERINE Pregnancy Drug Ineffective Drug Withdrawal Syndrome Dyskinesia Neonatal Dystonia Forceps Delivery Hypertonia Hypertonia Neonatal Hypotonia Neonatal Irritability Opisthotonus Overdose Poor Sucking Reflex Visual Tracking Test Abnormal Date:10/29/04ISR Number: 4489199-9Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20041005227 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Risperdal Consta PS INTRAMUSCULAR Rhodolgyl C OROPHARINGEAL 6 DF/ 3 times a day Tranxilium C Zyprexa C OROPHARINGEAL Vandral Retard I Depamide I OROPHARINGEAL Akineton Retard I OROPHARINGEAL Deprax I OROPHARINGEAL Date:10/29/04ISR Number: 4489200-2Report Type:Periodic Company Report #US-JNJFOC-20040808546 Age:78 YR Gender:Female I/FU:F Outcome PT Death Intestinal Obstruction Refusal Of Treatment By 22-Feb-2006 08:20 AM Page: 2316 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Relative Report Source Product Role Manufacturer Route Dose Duration Health Risperdal PS UNKNOWN Professional Risperdal SS UNKNOWN Date:10/29/04ISR Number: 4489210-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041005671 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Risperdal PS OROPHARINGEAL Initial or Prolonged Neutropenia Risperdal SS OROPHARINGEAL Deroxat C Deroxat C Tercian C UNKNOWN Date:10/29/04ISR Number: 4489211-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041005695 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Full Blood Count Risperdal Consta PS INTRAMUSCULAR Decreased Date:11/01/04ISR Number: 4491287-8Report Type:Expedited (15-DaCompany Report #B0348579A Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Foreign Paxil Tablet Phosphokinase Increased Literature (Paroxetine Depressed Level Of Health Hydrochloride) PS ORAL Consciousness Professional Risperidone Drug Withdrawal Syndrome (Formulation Hallucination Unknown) Neuroleptic Malignant (Risperidone) SS ORAL ORAL Syndrome Haloperidol Oliguria (Formulation Post Procedural Unknown) Complication (Haloperidol) SS Renal Impairment Date:11/01/04ISR Number: 4493092-5Report Type:Expedited (15-DaCompany Report #DSA_25214_2004 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Foreign Wypax PS ORAL 4 MG Q DAY PO Initial or Prolonged Consciousness Health Wypax SS ORAL 1 MG Q DAY PO Dysphagia Professional Akineton SS ORAL 3 MG Q DAY PO Intermittent Explosive Other Benzalin SS ORAL 10 MG Q DAY Disorder PO Pneumonia Aspiration Depas SS ORAL 1 MG Q DAY PO Pyothorax Lendormin SS ORAL 0.25 MG Q DAY PO Risperdal SS ORAL 3 MG Q DAY PO 22-Feb-2006 08:20 AM Page: 2317 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/04ISR Number: 4494619-XReport Type:Expedited (15-DaCompany Report #2004082912 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperchlorhydria Foreign Gabapentin Mood Altered Health (Gabapentin) PS ORAL (100 MG), Neutropenia Professional ORAL Ranitinde Hydrochloride (Ranitidine Hydrochloride) SS 150 MG (150 MG, 1 IN 1 D) Clozapine (Clozapine) SS ORAL (162.5 MG), ORAL Lamotrigine (Lamotrigine) SS ORAL ORAL Risperidone (Risperidone) SS ORAL (100 MG, 1 IN 1 D), ORAL Date:11/03/04ISR Number: 4494968-5Report Type:Expedited (15-DaCompany Report #2004-BP-10458RO Age:33 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Alprazolam Intensol Multiple Drug Overdose [Oral Solution (Concentrate) ] 1 Mg/ Ml (Alprazolam) PS Risperidone (Risperidone) SS Tranylcypromine (Tranylcypromine) SS Date:11/03/04ISR Number: 4494969-7Report Type:Expedited (15-DaCompany Report #2004-BP-10341RO Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Literature Alprazolam Intensol Completed Suicide [Oral Solution Multiple Drug Overdose (Concentrate) ] 1 Mg/ Ml (Diazepam) PS Citalopram (Citalopram) SS Risperidone (Risperidone) SS Date:11/04/04ISR Number: 4494393-7Report Type:Direct Company Report #CTU 231323 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Loss Of Consciousness Risperidone 1 Mg PS TWICE DAILY Disability Malaise 22-Feb-2006 08:20 AM Page: 2318 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/04/04ISR Number: 4498618-3Report Type:Expedited (15-DaCompany Report #US013994 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Study Fentanyl PS Hospitalization - Phosphokinase Increased Literature Clonazepam SS Initial or Prolonged Blood Creatinine Health Risperidone Increased Professional "Janssen" SS Blood Glucose Decreased Zidovudine Coma W/Lamivudine SS Drug Ineffective Progestine SS Kussmaul Respiration Albuterol SS Multiple Drug Overdose Anticonvulsant SS Polysubstance Abuse Angiotensin Receptor Antagonist SS Zolpidem SS Citalopram SS Valdecoxib SS Date:11/05/04ISR Number: 4493472-8Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20041006512 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hip Fracture Risperdal Consta PS INTRAMUSCULAR Hospitalization - Initial or Prolonged Date:11/05/04ISR Number: 4493473-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20041008061 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Risperdal Consta PS INTRAMUSCULAR Hepatitis Cholestatic Risperdal SS OROPHARINGEAL Hepatotoxicity Risperdal SS OROPHARINGEAL Ativan C Restoril C Date:11/05/04ISR Number: 4493474-1Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040907839 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Risperdal PS Cerebral Ischaemia Risperdal SS Epilepsy Risperdal SS Fatigue Citalopram C Tapered Menstrual Disorder Naproxen C Weight Increased Naproxen C Paracetamol C 7 TABLETS Date:11/05/04ISR Number: 4493475-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040903213 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Clonic Convulsion Risperdal PS OROPHARINGEAL Hospitalization - Myoclonic Epilepsy Risperdal SS OROPHARINGEAL Initial or Prolonged Respiratory Failure Depakine SS UNKNOWN Sedation Clozapine C Paroxetine C 22-Feb-2006 08:20 AM Page: 2319 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam C Tropatepine C Date:11/05/04ISR Number: 4493476-5Report Type:Periodic Company Report #FR-JNJFOC-20041003296 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Risperdal PS OROPHARINGEAL Initial or Prolonged Blood Potassium Decreased Haldol Decanoas SS INTRAMUSCULAR Blood Sodium Decreased Depamide SS OROPHARINGEAL Dose= 3 cp Blood Urea Decreased per day Convulsion Lepticur C Creatine Urine Abnormal Disorientation Haemoglobin Decreased Hyponatraemia Polydipsia Thirst Urea Urine Abnormal Urine Potassium Abnormal Weight Increased Date:11/05/04ISR Number: 4493778-2Report Type:Expedited (15-DaCompany Report #US-ABBOTT-04P-163-0279316-00 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Valproic Acid (Depakote Er) PS ORAL Risperidone SS ORAL Venlafaxine SS ORAL Date:11/05/04ISR Number: 4494259-2Report Type:Expedited (15-DaCompany Report #PHBS2004CH14715 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Insipidus Leponex PS Novartis Sector: Polydipsia Pharma UNKNOWN 350 mg/d Risperdal SS UNKNOWN 4 mg/d Tegretol C UNKNOWN 450 mg/d Temesta C UNKNOWN 6.5 mg/d Semap C ORAL 1 DF, QW2 Eltroxin C UNKNOWN 0.05 mg/d Calcium C ORAL 1 tablet/d Magnesiocard C UNKNOWN 10 mg/d Flatulex C UNKNOWN if needed Date:11/05/04ISR Number: 4494314-7Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0348579A Age:60 YR Gender:Female I/FU:F Outcome PT Other Blood Creatine Phosphokinase Increased Depressed Level Of Consciousness Musculoskeletal Stiffness Neuroleptic Malignant Syndrome 22-Feb-2006 08:20 AM Page: 2320 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oliguria Pyrexia Renal Impairment Report Source Product Role Manufacturer Route Dose Duration Paxil PS Glaxosmithkline ORAL Risperidone SS ORAL Haloperidol SS UNKNOWN Date:11/05/04ISR Number: 4495144-2Report Type:Direct Company Report #CTU 231387 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Risperdal PS ORAL 6 MG QHS (PO) Initial or Prolonged Blood Ketone Body Present Celexa C Diabetic Ketoacidosis Date:11/05/04ISR Number: 4497603-5Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20041006512 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hip Fracture Health Risperdal Consta PS INTRAMUSCULAR Hospitalization - Professional Initial or Prolonged Date:11/05/04ISR Number: 4497604-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041008061 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Effect Decreased Health Risperdal Consta PS INTRAMUSCULAR Hepatitis Cholestatic Professional Risperdal SS OROPHARINGEAL Hepatotoxicity Risperdal SS OROPHARINGEAL Ativan C Restoril C Date:11/05/04ISR Number: 4497605-9Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040907839 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Ischaemia Health Risperdal PS Epilepsy Professional Risperdal SS Fatigue Risperdal SS Foaming At Mouth Citalopram C Tapered Increased Bronchial Naproxen C Secretion Naproxen C Menstrual Disorder Paracetamol C 7 TABLETS Multi-Organ Disorder Nervous System Disorder Overgrowth Bacterial Pancreatic Disorder Weight Increased Date:11/05/04ISR Number: 4497606-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040903213 Age: Gender:Male I/FU:F Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:20 AM Page: 2321 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Clonic Convulsion Health Risperdal PS OROPHARINGEAL Respiratory Failure Professional Risperdal SS OROPHARINGEAL Sedation Depakine SS UNKNOWN Clozapine C Paroxetine C Lorazepam C Tropatepine C Date:11/05/04ISR Number: 4497607-2Report Type:Periodic Company Report #FR-JNJFOC-20041003296 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal PS OROPHARINGEAL Initial or Prolonged Hyponatraemia Professional Haldol Decanoas SS INTRAMUSCULAR Thirst Depamide SS OROPHARINGEAL Dose= 3 cp per day Lepticur C Date:11/08/04ISR Number: 4495474-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041100011 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Risperdal PS OROPHARINGEAL 0.5mg-1mg Other daily Date:11/08/04ISR Number: 4495475-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040607731 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amenorrhoea Risperdal PS OROPHARINGEAL Initial or Prolonged Anxiety Risperdal SS OROPHARINGEAL 4-2-4 Breast Tenderness Risperdal SS OROPHARINGEAL Delusion Tercian SS OROPHARINGEAL Galactorrhoea Tercian SS OROPHARINGEAL Hyperprolactinaemia Tercian SS OROPHARINGEAL Oculogyration Tercian SS OROPHARINGEAL Psychotic Disorder Risperdal SS OROPHARINGEAL Weight Increased Deroxat C Xanax C 0.25 mg Date:11/08/04ISR Number: 4495497-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908713 Age:8 YR Gender:Female I/FU:I Outcome PT Death Acidosis Brain Death Bronchopneumonia Cerebral Infarction Cerebrovascular Accident Cholestasis Hepatic Necrosis Intracranial Pressure Increased Multi-Organ Failure 22-Feb-2006 08:20 AM Page: 2322 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neuroleptic Malignant Syndrome Rhabdomyolysis Report Source Product Role Manufacturer Route Dose Duration Sepsis Haldol PS PARENTERAL Risperdal SS UNKNOWN Chlorpromazine SS UNKNOWN Diphenhydramine SS Lorazepam SS Date:11/08/04ISR Number: 4495505-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041007639 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Anxiety Restlessness Date:11/08/04ISR Number: 4497584-4Report Type:Expedited (15-DaCompany Report #PT-JNJFOC-20041007114 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Goitre Risperdal PS OROPHARINGEAL Lupus-Like Syndrome Risperdal SS OROPHARINGEAL Pericardial Effusion Lamotrigina C Bromazepam C Date:11/08/04ISR Number: 4497585-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041007637 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Risperdal PS OROPHARINGEAL 1.5 MG bd - Neutropenia 100 MG daily, White Blood Cell Count per source Decreased documents 21 DAY Clozapine SS OROPHARINGEAL Ranitidine SS Gabapentin SS OROPHARINGEAL Lamotrigine SS OROPHARINGEAL Date:11/08/04ISR Number: 4497586-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041008034 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Risperdal PS OROPHARINGEAL Initial or Prolonged Consciousness Risperdal SS OROPHARINGEAL Other Diet Refusal Dyskinesia Eating Disorder Headache Date:11/08/04ISR Number: 4497588-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041008684 Age:80 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperdal PS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2323 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/04ISR Number: 4497589-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041008685 Age:88 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperdal PS OROPHARINGEAL Date:11/08/04ISR Number: 4497590-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040704586 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Health Risperdal PS OROPHARINGEAL Anaemia Professional Risperdal SS OROPHARINGEAL Blood Amylase Increased Risperdal SS OROPHARINGEAL Drug Ineffective Risperdal SS OROPHARINGEAL Hyperlipidaemia Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Propranolol Hydrochloride C OROPHARINGEAL Tandospirone Citrate C OROPHARINGEAL Tandospirone Citrate C OROPHARINGEAL Date:11/08/04ISR Number: 4497591-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041000543 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blepharospasm Risperdal PS OROPHARINGEAL Weight Increased Fluoxetine C OROPHARINGEAL Diazepam C OROPHARINGEAL Date:11/08/04ISR Number: 4497688-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041008024 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Megaloblastic Risperdal PS OROPHARINGEAL Initial or Prolonged Drug Interaction Chlorpromazine SS 1 dose daily Chlorpromazine SS 1 dose daily Chlorpromazine SS 1 dose daily Promethazine SS 1 dose daily Promethazine SS 1 dose daily 22-Feb-2006 08:20 AM Page: 2324 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Promethazine SS 1 dose daily Date:11/08/04ISR Number: 4497689-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041005849 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholinergic Syndrome Health Risperdal PS Initial or Prolonged Constipation Professional Risperdal SS Dysuria Sennoside C Extrapyramidal Disorder Clomipramine Obsessive-Compulsive Hydrochloride C Disorder Biperiden Hydrochloride C Date:11/08/04ISR Number: 4497690-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041003531 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Scan Abnormal Risperdal PS OROPHARINGEAL Initial or Prolonged Depressed Level Of Trileptal C Consciousness Sulfarlem C Dyskinesia Stilnox C Electroencephalogram Urbanyl C Abnormal Hypertonia Miosis Prostration Sedation Date:11/08/04ISR Number: 4497691-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041006710 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drug Exposure During Risperdal PS INTRA-UTERINE Congenital Anomaly Pregnancy Haloperidol C Foetal Disorder Gastroschisis Date:11/08/04ISR Number: 4497692-8Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20040907839 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Health Risperdal PS Cardiomyopathy Professional Risperdal SS Central Nervous System Risperdal SS Infection Citalopram C Cerebral Ischaemia Citalopram C Tapered Epilepsy Naproxen C Fatigue Naproxen C Menstrual Disorder Paracetamol C 500 mg -7 Myocardial Calcification TABLETS in 3 Pancreatic Disorder days Scar Lactulose C Since the age Weight Increased of 4 22-Feb-2006 08:20 AM Page: 2325 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/08/04ISR Number: 4498770-XReport Type:Expedited (15-DaCompany Report #2004BL007056 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Literature Albuterol Sulfate Phosphokinase Increased Health Inhalation Solution Blood Creatinine Professional 0.5% PS Increased Fentanyl SS ORAL ORAL Coma Clonazepam SS ORAL ORAL Drug Abuser Risperidone SS ORAL ORAL Drug Ineffective Zidovudine Hypoglycaemia W/Lamivudine SS Kussmaul Respiration Progestin SS Multiple Drug Overdose Unspecified Anticonvulsant SS Unspecified Angiotensin Receptor Antagonist SS Zolpidem SS Citalopram SS Valdecoxib SS Glyburide C Date:11/09/04ISR Number: 4496437-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040501364 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Risperdal PS OROPHARINGEAL 15 MON Infertility Liver Disorder Pituitary Tumour Benign Date:11/09/04ISR Number: 4496554-XReport Type:Expedited (15-DaCompany Report #IT-JNJFOC-20041100006 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Contractions Risperdal PS OROPHARINGEAL weekly dosing Initial or Prolonged Involuntary administratio Subdural Haematoma n started 2 months ago. Date:11/09/04ISR Number: 4496555-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041100357 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Motor Dysfunction Risperdal PS OROPHARINGEAL Movement Disorder Muscle Spasticity Date:11/09/04ISR Number: 4496556-3Report Type:Expedited (15-DaCompany Report #PL-JNJFOC-20041101664 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Masked Facies Rispolept PS OROPHARINGEAL Dose: 3-4 mg Myasthenic Syndrome Salivary Hypersecretion Sleep Disorder Tongue Paralysis 22-Feb-2006 08:20 AM Page: 2326 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/04ISR Number: 4496557-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040905265 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Antidepressant Drug Level Risperdal PS OROPHARINGEAL Initial or Prolonged Increased Tercian SS OROPHARINGEAL Drug Interaction Depamide SS OROPHARINGEAL Laroxyl I OROPHARINGEAL Laroxyl I OROPHARINGEAL Date:11/09/04ISR Number: 4501712-1Report Type:Expedited (15-DaCompany Report #S04-CAN-06399-01 Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Foreign Memantine PS ORAL 10 MG BID PO Insomnia Health Reminyl Irritability Professional /Usa/(Galantamine Other Hydrobromide) SS ORAL 24 MG QD PO Risperdal (Risperidone) SS ORAL 0.25 MG QD PO Imovane (Zopiclone) C Date:11/10/04ISR Number: 4497248-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908213 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Risperdal PS OROPHARINGEAL Risperdal SS OROPHARINGEAL Date:11/10/04ISR Number: 4497631-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041102038 Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Transient Risperdal PS OROPHARINGEAL Date:11/10/04ISR Number: 4497865-4Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0045137A Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Health Quilonum Retard PS Glaxosmithkline ORAL 2.5TAB Per Initial or Prolonged Dehydration Professional day Disorientation Risperdal SS ORAL 1MG Per day Eyelid Oedema Ergenyl SS ORAL 150MG Per day Nephropathy Haldol Decanoate C INTRAMUSCULAR 1ML Monthly Oedema Peripheral Perazin C UNKNOWN Renal Failure Benalapril C ORAL 5MG Per day Salt Intoxication Diazepam C ORAL 40MG Per day Somnolence Thyronajod C ORAL .1MG Per day Urinary Tract Infection Kalinor C Glaxosmithkline ORAL 1TAB Per day Lasix C Glaxosmithkline UNKNOWN 40MG Per day DAY Hct C UNKNOWN 25MG Per day Taxilan C UNKNOWN 900MG per day Haldol C UNKNOWN 60MG per day Akineton C UNKNOWN 1TAB Per day Gastrozepin C UNKNOWN 75MG per day Pantozol C UNKNOWN 40MG Per day Clexane C SUBCUTANEOUS .4U Per day Zoloft C UNKNOWN 100MG Unknown 22-Feb-2006 08:20 AM Page: 2327 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurocil C UNKNOWN Date:11/10/04ISR Number: 4502401-XReport Type:Expedited (15-DaCompany Report #S04-FRA-07357-01 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Seropram (Citalopram Initial or Prolonged Disorientation Health Hydrobromide) PS ORAL 20 MG BID PO Intentional Overdose Professional Lormetazepam SS ORAL 2 MG BID PO Somnolence Other Risperdal (Risperidone) SS ORAL 4 MG BID PO Artane (Trihexyphenidyl Hydrochloride) C Date:11/10/04ISR Number: 4502580-4Report Type:Expedited (15-DaCompany Report #DEWYE160729OCT04 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Health Trevilor Initial or Prolonged Intentional Overdose Professional (Venlafaxine Miosis Hydrochloride, Tachycardia Tablet, 0) PS ORAL 2 TABLETS (OVERDOSE AMOUNT 125 MG) ORAL 1 DAY Risperdal (Risperidone, 0) SS ORAL 6 TABLETS IN 12 HOURS, ORAL 1 DAY Stangyl (Trimipramine Maleate, , 0) SS ORAL 1 TABLET, ORAL 1 DAY Zoloft (Sertraline Hydrochloride, , 0) SS ORAL 20 TABLETS (OVERDOSE AMOUTN 1000 MG), ORAL 1 DAY Zyprexa (Olanzapine, , 0) SS ORAL 3 TABLETS, ORAL 1 DAY Date:11/11/04ISR Number: 4499080-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908242 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Health Duragesic PS OROPHARINGEAL Hospitalization - Phosphokinase Increased Professional Risperidone SS OROPHARINGEAL Initial or Prolonged Blood Creatinine Clonazepam SS OROPHARINGEAL Increased Lamivudine C Coma Progestin C Drug Abuser Anticonvulsant C Intentional Misuse Albuterol C Kussmaul Respiration Angiotensin Receptor Multiple Drug Overdose Antagonist C Intentional Zolpidem C Respiratory Depression Citalopram C 22-Feb-2006 08:20 AM Page: 2328 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Valdecoxib C Date:11/11/04ISR Number: 4499081-9Report Type:Expedited (15-DaCompany Report #BR-JNJFOC-20041101771 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coagulopathy Risperdal PS OROPHARINGEAL Petechiae Reminyl SS OROPHARINGEAL Platelet Count Decreased Date:11/11/04ISR Number: 4499082-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041102449 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal PS OROPHARINGEAL Other Drugs C Date:11/11/04ISR Number: 4499083-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041008024 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Megaloblastic Health Risperdal PS OROPHARINGEAL Initial or Prolonged Anaemia Vitamin B12 Professional Risperdal SS OROPHARINGEAL Deficiency Chlorpromazine SS 1 dose daily Chlorpromazine SS 1 dose daily Chlorpromazine SS 1 dose daily Promethazine SS 1 dose daily Promethazine SS 1 dose daily Promethazine SS 1 dose daily Date:11/11/04ISR Number: 4499182-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041102704 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:11/11/04ISR Number: 4499183-7Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040910153 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS OROPHARINGEAL White Blood Cell Count Decreased Date:11/11/04ISR Number: 4499256-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908824 Age:25 YR Gender:Male I/FU:I Outcome PT Death Coma Completed Suicide General Physical Health Deterioration Haemodialysis Heart Rate Increased Hypotension 22-Feb-2006 08:20 AM Page: 2329 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loss Of Consciousness Multiple Drug Overdose Intentional Report Source Product Role Manufacturer Route Dose Duration Pneumothorax Ultram PS OROPHARINGEAL Therapy Non-Responder Ultracet SS OROPHARINGEAL Risperidone SS Lithium SS OROPHARINGEAL Alprazolam SS Diazepam SS Nefazodone SS Olanzapine SS Nalbuphine SS Date:11/12/04ISR Number: 4499912-2Report Type:Expedited (15-DaCompany Report #PT-JNJFOC-20040903191 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Incontinence Health Risperdal PS OROPHARINGEAL Hospitalization - Infection Professional Artane C OROPHARINGEAL Initial or Prolonged Neuroleptic Malignant Diazepam C OROPHARINGEAL 5 mg strength Syndrome Date:11/12/04ISR Number: 4500154-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040802826 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Health Risperdal PS OROPHARINGEAL (taken at Homicidal Ideation Professional bedtime) Suicidal Ideation Risperdal SS OROPHARINGEAL Ultram SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Dilantin C Ibuprofen C Dapsone C Trazodone C 50-100 mg nightly Date:11/12/04ISR Number: 4502915-2Report Type:Expedited (15-DaCompany Report #2004UW19322 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Study Seroquel PS ORAL 300 MG BID PO Initial or Prolonged Hallucination, Auditory Health Risperdal SS ORAL 1.5 MG BID PO Psychotic Disorder Professional Zoloft C Suicidal Ideation Ativan C Aspirin C Date:11/15/04ISR Number: 4500597-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041101685 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Blood Creatine Phosphokinase Increased Confusional State Pallor 22-Feb-2006 08:20 AM Page: 2330 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/04ISR Number: 4500598-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041102118 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Reminyl SS OROPHARINGEAL Date:11/15/04ISR Number: 4500650-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040603091 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Rigidity Risperdal PS OROPHARINGEAL Tardive Dyskinesia Aricept C Stilnox C Date:11/15/04ISR Number: 4500651-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040807481 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accident Health Risperdal PS OROPHARINGEAL Drowning Professional Risperdal SS OROPHARINGEAL Mental Disorder Date:11/15/04ISR Number: 4500816-7Report Type:Expedited (15-DaCompany Report #JP-MERCK-0411USA01770 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multi-Organ Failure Cozaar PS Merck & Co., Inc ORAL 24 DAY Neuroleptic Malignant Symmetrel SS ORAL Syndrome Zyprexa SS ORAL Risperdal SS ORAL Date:11/15/04ISR Number: 4501891-6Report Type:Direct Company Report #CTU 231973 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Risperidone PS ORAL 0.5 MG QH, Initial or Prolonged 0.5 MG QH Required ORAL Intervention to Risperidone 1 Mg Tab SS Prevent Permanent Heparin C Impairment/Damage Phenytoin Susp Susp C Temazepam C Omeprazole C Lactulose Syrup C Clopidogrel C Aspirin Ec C Benzotropine C Date:11/16/04ISR Number: 4501850-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041103377 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Crohn'S Disease Risperdal PS OROPHARINGEAL Hospitalization - Glucotrol C Initial or Prolonged Actose C Lipitor C 22-Feb-2006 08:20 AM Page: 2331 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Asacol C Pepcid C Flexeril C Date:11/16/04ISR Number: 4502157-0Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20041000044 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Fall Risperdal SS OROPHARINGEAL Head Injury Ditropan C OROPHARINGEAL Neoplasm Fludex C OROPHARINGEAL Wound Moxon C OROPHARINGEAL Date:11/16/04ISR Number: 4502158-2Report Type:Expedited (15-DaCompany Report #KR-JNJFOC-20041103076 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Risperdal PS OROPHARINGEAL Initial or Prolonged Nephrolithiasis Risperdal SS OROPHARINGEAL Date:11/16/04ISR Number: 4502159-4Report Type:Periodic Company Report #US-JNJFOC-20040904697 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Emphysema Risperdal PS OROPHARINGEAL Date:11/16/04ISR Number: 4502160-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908846 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Health Risperdal PS UNKNOWN Professional Date:11/16/04ISR Number: 4502367-2Report Type:Expedited (15-DaCompany Report #PHHO2004CA11926 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Creatine Clozaril PS Novartis Sector: Phosphokinase Increased Pharma ORAL 550 mg, QD 301 DAY Dehydration Risperdal SS 20160MIN Muscle Rigidity Valproic Acid C Neuroleptic Malignant Ativan C Syndrome Tachycardia Date:11/16/04ISR Number: 4503066-3Report Type:Direct Company Report #CTU 232091 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Risperdal 0.5 Mg PS ORAL 0.5 MG Hypoaesthesia BEDTIME ORAL Treatment Noncompliance Effexor Xr C Luvox C Trileptal C 22-Feb-2006 08:20 AM Page: 2332 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/04ISR Number: 4505234-3Report Type:Expedited (15-DaCompany Report #DSA_25305_2004 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Ischaemia Foreign Tavor PS ORAL 1 MG Q DAY PO Initial or Prolonged Dehydration Health Enalarpil SS ORAL DF Q DAY PO Depression Professional Enalarpil SS ORAL 5 MG Q DAY Dizziness Other PO Drug Interaction Remergil SS ORAL 30 MG Q DAY Hypotension PO Somnolence Risperdal SS ORAL 1 MG Q DAY PO Risperdal SS ORAL 0.5 MG Q DAY PO Date:11/16/04ISR Number: 4525650-3Report Type:Periodic Company Report #S04-USA-05902-01 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Consumer Namenda (Memantine) PS ORAL 5 MG QD PO Namenda (Memantine) SS ORAL 10 MG QD PO Namenda (Memantine) SS ORAL 15 MG QD PO Namenda (Memantine) SS ORAL 20 MG QD PO Risperdal (Risperidone) SS ORAL 2 MG QHS PO Meclizine C Zebeta (Bisoprolol Fumarate) C Xanax (Alprazolam) C Depakote (Valproate Semisodium) C Allegra (Fexofenadine Hydrochloride) C Pepcid (Famotidine) C Hydrocodone C Paxil (Paroxetine Hydrochloride) C Lasix (Furosemide) C Potassium C Date:11/17/04ISR Number: 4502824-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041102035 Age:4 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Orthostatic Hypotension Risperdal PS OROPHARINGEAL Petit Mal Epilepsy Date:11/17/04ISR Number: 4502825-0Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20041102372 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decubitus Ulcer Risperdal Consta PS INTRAMUSCULAR 43 DAY Initial or Prolonged Amisulpride SS Aripiprazole SS 22-Feb-2006 08:20 AM Page: 2333 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4502826-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040506140 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperprolactinaemia Risperdal PS OROPHARINGEAL Initial or Prolonged Metrorrhagia Risperdal SS OROPHARINGEAL Ovarian Cyst Risperdal SS OROPHARINGEAL Surgery Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Bromocriptine Mesylate C OROPHARINGEAL Brotizolam C OROPHARINGEAL Ethyl Loflazepate C OROPHARINGEAL Diazepam C OROPHARINGEAL Chlorpromazine Hydrochloride C OROPHARINGEAL Date:11/17/04ISR Number: 4502827-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041008685 Age:88 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperdal PS OROPHARINGEAL Mianserin Hydrochloride C Levomepromazine Maleate C Date:11/17/04ISR Number: 4503437-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041008684 Age:80 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Health Risperdal PS OROPHARINGEAL Professional Risperdal SS OROPHARINGEAL Tiapride Hydrochloride C Sodium Valproate C Zolpidem Tartrate C Date:11/17/04ISR Number: 4503438-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040708058 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Hallucination, Auditory Risperdal Consta SS INTRAMUSCULAR Memory Impairment Risperdal SS OROPHARINGEAL Somnolence Risperdal SS OROPHARINGEAL 2 mg in am 3 mg in pm Synthroid C OROPHARINGEAL Date:11/17/04ISR Number: 4503606-4Report Type:Expedited (15-DaCompany Report #PHHO2004CH15760 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Pain Trileptal Fmi PS Novartis Sector: Initial or Prolonged Drug Interaction Pharma 150-450 mg/d Galactorrhoea Risperdal SS 1mg/d 18720MIN 22-Feb-2006 08:20 AM Page: 2334 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4504434-6Report Type:Direct Company Report #CTU 232346 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Seroquel 100 Mg PS ORAL 100 MG PO BID 6 MON Initial or Prolonged Communication Disorder Risperdal 2 Mg SS ORAL 2 MG PO QHS 6 MON Neuroleptic Malignant Zoloft C Syndrome Valproic Acid C Date:11/18/04ISR Number: 4504634-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041102400 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Risperdal PS OROPHARINGEAL Drug Level Increased Risperdal SS OROPHARINGEAL Dyskinesia Zoloft I OROPHARINGEAL Oropharyngeal Spasm Zoloft I OROPHARINGEAL Salivary Hypersecretion Speech Disorder Date:11/18/04ISR Number: 4504635-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041102760 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Orthostatic Hypotension Risperdal Consta SS INTRAMUSCULAR Speech Disorder Staring Date:11/18/04ISR Number: 4504636-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041104130 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Status Epilepticus Risperdal PS OROPHARINGEAL Initial or Prolonged Date:11/18/04ISR Number: 4504637-0Report Type:Expedited (15-DaCompany Report #KR-JNJFOC-20041103076 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Risperdal PS OROPHARINGEAL Initial or Prolonged Nephrolithiasis Risperdal SS OROPHARINGEAL Date:11/18/04ISR Number: 4504638-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040800557 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Candiduria Risperdal PS OROPHARINGEAL Cardio-Respiratory Arrest Risperdal SS OROPHARINGEAL Drug Interaction Paxil SS OROPHARINGEAL Lung Infection Digoxin C Pseudomonal Cardizem C Metabolic Encephalopathy Prednisone C Pancytopenia Lovenox C Staphylococcal Bacteraemia 22-Feb-2006 08:20 AM Page: 2335 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/18/04ISR Number: 4507606-XReport Type:Expedited (15-DaCompany Report #B0349608A Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Confusional State Foreign Lithium Salt Intervention to Disturbance In Attention Literature (Generic) (Lithium Prevent Permanent Drug Interaction Health Salt) PS PER DAY Impairment/Damage Dysphoria Professional Lamictal Lethargy (Lamotrigine) SS Mania Risperidone Skin Disorder (Risperidone) SS Therapeutic Agent Topiramate Toxicity (Topiramate) SS 75 MG Valproate Sodium C Clonazepam C Date:11/19/04ISR Number: 4505101-5Report Type:Expedited (15-DaCompany Report #AU-ABBOTT-04P-008-0280325-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Epilim PS ORAL 6 DAY Initial or Prolonged Confusional State Risperidone SS ORAL Drug Interaction Risperidone SS ORAL Sedation Date:11/19/04ISR Number: 4506000-5Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20041102546 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diarrhoea Consumer Risperdal PS Dose unknown Inflammation Tefor C OROPHARINGEAL Urinary Tract Disorder Date:11/19/04ISR Number: 4506001-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041102744 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Haemorrhage Health Risperdal PS OROPHARINGEAL Initial or Prolonged Congenital Professional Jatrosom N SS OROPHARINGEAL Cerebrovascular Anomaly Tegretal SS OROPHARINGEAL Embolism Hypnorex C OROPHARINGEAL Pancytopenia Pneumonia Vasculitis Date:11/19/04ISR Number: 4506002-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041103446 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Progressive Supranuclear Risperdal PS Dose: Between Palsy 0.5 and 1 mg bd 22-Feb-2006 08:20 AM Page: 2336 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/04ISR Number: 4506003-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040910003 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Health Risperdal PS OROPHARINGEAL Initial or Prolonged Cerebellar Syndrome Professional Confusional State Medication Error Somnolence Tonic Convulsion Urinary Incontinence Date:11/19/04ISR Number: 4506004-2Report Type:Periodic Company Report #FR-JNJFOC-20041100357 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Muscle Spasticity Risperdal PS OROPHARINGEAL Zyprexa SS Date:11/19/04ISR Number: 4509967-4Report Type:Expedited (15-DaCompany Report #2004243359JP Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Foreign Cabaser Syndrome Health (Cabergoline) Professional Tablet, 1-4mg PS ORAL SEE IMAGE Other Permax (Pergolide Mesilate) SS ORAL ORAL Risperdal (Risperidone) SS ORAL ORAL Zotepine (Zotepine) SS ORAL ORAL Date:11/19/04ISR Number: 4512791-XReport Type:Direct Company Report #CTU 232466 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Risperidone Insulin-Dependent Alkaloid PS ORAL UP TO 3 MG/D Ketoacidosis ONCE A DAY Treatment Noncompliance ORAL Rispolept SS ORAL UP TO 4MG/D ONCE A DAY ORAL Date:11/19/04ISR Number: 4512847-1Report Type:Direct Company Report #CTU 232475E Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Olanzapine PS ORAL 20 MG HS Initial or Prolonged Diabetes Mellitus ORAL Weight Increased Risperidone SS ORAL 2 MG BID ORAL 22-Feb-2006 08:20 AM Page: 2337 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/04ISR Number: 4506622-1Report Type:Expedited (15-DaCompany Report #JP-MERCK-0411USA01770 Age:78 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Chronic Cozaar PS Merck & Co., Inc ORAL 23 DAY Hospitalization - Decreased Appetite Cozaar SS Merck & Co., Inc ORAL Initial or Prolonged Depressed Level Of Cozaar SS Merck & Co., Inc ORAL 23 DAY Consciousness Cozaar SS Merck & Co., Inc ORAL Femoral Neck Fracture Symmetrel SS ORAL Hypertension Zyprexa SS ORAL Multi-Organ Failure Risperdal SS ORAL Neuroleptic Malignant Syndrome Date:11/23/04ISR Number: 4507767-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041102397 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticonvulsant Drug Level Risperdal PS OROPHARINGEAL Initial or Prolonged Below Therapeutic Risperdal SS OROPHARINGEAL Antipsychotic Drug Level Risperdal SS OROPHARINGEAL Above Therapeutic Risperdal SS OROPHARINGEAL Blood Creatine Risperdal SS OROPHARINGEAL Phosphokinase Mb Quilonum Retard SS 1 tablet Increased Quilonum Retard SS 2 tablets Csf Oligoclonal Band Quilonum Retard SS 1 tablet Present Quilonum Retard SS 1 tablet Dehydration Ergenyl SS OROPHARINGEAL Electrocardiogram Qt Ergenyl SS OROPHARINGEAL Corrected Interval Ergenyl SS OROPHARINGEAL Prolonged Ergenyl SS OROPHARINGEAL Extrapyramidal Disorder Ergenyl SS OROPHARINGEAL Eyelid Oedema Ergenyl SS OROPHARINGEAL Fall Ergenyl SS OROPHARINGEAL Hepatitis Quilonum Retard SS 2.5 tablets Infection Quilonum Retard SS 2.5 tablets Nephropathy Toxic Quilonum Retard SS 1.5 tablets Quilonum Retard SS 2 tablets Haldol SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Haldol C INTRAMUSCULAR Taxilan C OROPHARINGEAL Taxilan C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Benalapril C OROPHARINGEAL Benalapril C OROPHARINGEAL Thyronajod C OROPHARINGEAL Thyronajod C OROPHARINGEAL Kalinor C 1 tablet Hydrochlorothiazide C 22-Feb-2006 08:20 AM Page: 2338 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/04ISR Number: 4507768-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041103323 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS OROPHARINGEAL Date:11/23/04ISR Number: 4507769-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041104401 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Lymphocytic Risperdal PS UNKNOWN "high dosage" 49 MON Leukaemia Risperdal SS UNKNOWN 49 MON Alpha Haemolytic Streptococcal Infection Blood Pressure Decreased Catheter Site Related Reaction Diabetes Mellitus Non-Insulin-Dependent Febrile Neutropenia Hyperprolactinaemia Pneumonia Respiratory Failure Respiratory Rate Increased Sepsis Stem Cell Transplant Tremor Date:11/23/04ISR Number: 4511660-9Report Type:Direct Company Report #CTU 232839 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Status Changes Risperidone PS Initial or Prolonged Fentanyl Patch SS Levothyroxine C Nitroglycerin Patch C Benazepril C Nephrocaps C Aspirin C Carvedilol C Date:11/23/04ISR Number: 4527890-6Report Type:Periodic Company Report #US-JNJFOC-20041100429 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Consta Diabetes Mellitus Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R 22-Feb-2006 08:20 AM Page: 2339 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/04ISR Number: 4527891-8Report Type:Periodic Company Report #US-JNJFOC-20041005763 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Microspheres PS INTRAMUSCULAR INTRAMUSCULAR Date:11/23/04ISR Number: 4527892-XReport Type:Periodic Company Report #US-JNJFOC-20041005742 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Risperdal Consta Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Prozac (Fluoxetine Hydrochloride) C Abilify (Aripiprazole) C Date:11/23/04ISR Number: 4527893-1Report Type:Periodic Company Report #US-JNJFOC-20041003515 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Consta Initial or Prolonged Diabetes Mellitus Professional (Risperidone) Psychotic Disorder Microspheres PS ORAL 25 MG, INTRAMUSCULAR ; 3 MG, IN 1 DAY, ORAL Risperidone (Risperidone) Tablets SS ORAL 6 MG, IN 1 DAY, ORAL Glipizide (Glipizide) C Rosiglitazone (Rosiglitazone) C Metformin (Metformin) C Celexa (Citalopram Hydrobromide) C Depakote (Valproate Semisodium) C Trazadone (Trazodone) C Lisinopril (Lisinopril) C Date:11/23/04ISR Number: 4527894-3Report Type:Periodic Company Report #US-JNJFOC-20041001512 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Health Risperdal Consta Initial or Prolonged Schizophrenia Professional (Risperidone) Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN 22-Feb-2006 08:20 AM Page: 2340 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 2 WEEK, INTRAMUSCULAR Risperdal (Risperidone) Tablets SS 8 MG, 1 IN 1 DAY Geodon (Tablets) Ziprasidone Hydrochloride C Xanax (Alprazolam) C Date:11/23/04ISR Number: 4527895-5Report Type:Periodic Company Report #US-JNJFOC-20040908268 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Other Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRAMUSCULAR Date:11/23/04ISR Number: 4527896-7Report Type:Periodic Company Report #US-JNJFOC-20040907911 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amenorrhoea Health Risperdal Consta Initial or Prolonged Blood Prolactin Increased Professional (Risperidone) PS INTRAMUSCULAR 37.5 MG, 1 IN Condition Aggravated 2 WEEK, Galactorrhoea INTRA-MUSCULA Schizophrenia R; SEE IMAGE Risperdal (Risperidone) Tablets SS ORAL ORAL Haldol (Haloperidol) Tablets SS 10 MG, 1 IN 1 DAY Seroquel (Quetiapine Fumarate) C Date:11/23/04ISR Number: 4527897-9Report Type:Periodic Company Report #US-JNJFOC-20040905195 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Musculoskeletal Stiffness Health Risperdal Consta Initial or Prolonged Tongue Oedema Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Representative WEEK, INTRAMUSCULAR Risperdal (Risperidone) Tablets SS ORAL 4 MG, ORAL Date:11/23/04ISR Number: 4527898-0Report Type:Periodic Company Report #US-JNJFOC-20040806848 Age: Gender:Unknown I/FU:I Outcome PT Report Source Hospitalization - Condition Aggravated Health Initial or Prolonged Professional 22-Feb-2006 08:20 AM Page: 2341 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Company Representative Product Role Manufacturer Route Dose Duration Risperdal Consta (Risperidone) Microspheres PS INTRAMUSCULAR INTRA-MUSCULA R Date:11/23/04ISR Number: 4527899-2Report Type:Periodic Company Report #US-JNJFOC-20040803920 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Risperdal Consta Myocardial Infarction Professional (Risperidone) Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Seroquel (Quetiapine Fumarate) C Plavix (Clopidogrel Sulfate) C Zocor (Simvastatin) C Glipizide (Glipizide) C Date:11/23/04ISR Number: 4527901-8Report Type:Periodic Company Report #US-JNJFOC-20040801232 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Risperdal Consta Initial or Prolonged Hallucination Professional (Risperidone) Microspheres PS INTRAMUSCULAR 3.75 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal Consta (Risperidone) Microspheres SS INTRAMUSCULAR 50 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Tablets) Risperidone C Date:11/23/04ISR Number: 4527902-XReport Type:Periodic Company Report #US-JNJFOC-20040801231 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bipolar Disorder Health Risperdal Consta Initial or Prolonged Condition Aggravated Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal Consta (Risperidone) Microspheres SS INTRAMUSCULAR 50 MG, 1 IN 2 22-Feb-2006 08:20 AM Page: 2342 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report WEEK, INTRA-MUSCULA R Risperdal (Tablets) Risperidone C Date:11/23/04ISR Number: 4527903-1Report Type:Periodic Company Report #US-JNJFOC-20040801218 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Risperdal Consta Initial or Prolonged Mania Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal Consta (Risperidone) Microspheres SS INTRAMUSCULAR 50 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Tablets) Risperidone C Date:11/23/04ISR Number: 4527904-3Report Type:Periodic Company Report #US-JNJFOC-20040800518 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Health Risperdal Consta Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR INTRA-MUSCULA Representative R Date:11/23/04ISR Number: 4527905-5Report Type:Periodic Company Report #US-JNJFOC-20040706005 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaphylactic Reaction Health Risperdal Consta Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) C Seroquel (Quetiapine Fumarate) C Trazodone (Trazodone) C Effexor Xr (Venlafaxine Hydrochloride) C Vistaril (Hydroxyzine Embonate) C Milk Of Magnesia (Magnesium Hydroxide) C 22-Feb-2006 08:20 AM Page: 2343 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Synthroid (Levothyroxine Sodium) C Folic Acid (Folic Acid) C Zyprexa (Olanzapine) C Thiamine (Thiamine) C Date:11/23/04ISR Number: 4527906-7Report Type:Periodic Company Report #US-JNJFOC-20040404440 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Consta Blood Pressure Increased (Risperidone) Fatigue Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Hyperglycaemia WEEK, Hypoglycaemia INTRA-MUSCULA Increased Appetite R Libido Decreased Risperdal Oedema (Risperidone) Salivary Hypersecretion Solution SS ORAL 5 MG, 1 IN 1 Tachycardia DAY, ORAL Visual Acuity Reduced Depakote (Tablets) Weight Increased Valproate Semisodium C Synthroid (Tablets) Levothyroxine Sodium C Date:11/23/04ISR Number: 4527907-9Report Type:Periodic Company Report #US-JNJFOC-20040502153 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) C Lithium (Lithium) C Date:11/23/04ISR Number: 4527908-0Report Type:Periodic Company Report #US-JNJFOC-20040504305 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Risperdal Consta Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Addreall (Obetrol) C Focalin (All Other Therapeutic Products) C 22-Feb-2006 08:20 AM Page: 2344 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/24/04ISR Number: 4509711-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041102397 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticonvulsant Drug Level Risperdal PS OROPHARINGEAL Initial or Prolonged Below Therapeutic Risperdal SS OROPHARINGEAL Antipsychotic Drug Level Risperdal SS OROPHARINGEAL Above Therapeutic Risperdal SS OROPHARINGEAL Blood Creatine Risperdal SS OROPHARINGEAL Phosphokinase Mb Quilonum Retard SS 1 tablet Increased Quilonum Retard SS 2 tablets Csf Oligoclonal Band Quilonum Retard SS 1 tablet Present Quilonum Retard SS 1 tablet Dehydration Ergenyl SS OROPHARINGEAL Electrocardiogram Qt Ergenyl SS OROPHARINGEAL Corrected Interval Ergenyl SS OROPHARINGEAL Prolonged Ergenyl SS OROPHARINGEAL Extrapyramidal Disorder Ergenyl SS OROPHARINGEAL Eyelid Oedema Ergenyl SS OROPHARINGEAL Fall Ergenyl SS OROPHARINGEAL Hepatitis Quilonum Retard SS 2.5 tablets Infection Quilonum Retard SS 2.5 tablets Lumbar Puncture Abnormal Quilonum Retard SS 1.5 tablets Nephropathy Toxic Quilonum Retard SS 2 tablets Haldol SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Haldol C INTRAMUSCULAR Taxilan C OROPHARINGEAL Taxilan C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Benalapril C OROPHARINGEAL Benalapril C OROPHARINGEAL Thyronajod C OROPHARINGEAL Thyronajod C OROPHARINGEAL Kalinor C 1 tablet Hydrochlorothiazide C Date:11/24/04ISR Number: 4509712-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041103323 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS OROPHARINGEAL Date:11/24/04ISR Number: 4509713-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041104401 Age:32 YR Gender:Female I/FU:I Outcome PT Death Acute Lymphocytic Leukaemia Alpha Haemolytic Streptococcal Infection Bacteraemia Blood Pressure Decreased Catheter Site Discharge 22-Feb-2006 08:20 AM Page: 2345 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diabetes Mellitus Non-Insulin-Dependent Febrile Neutropenia Report Source Product Role Manufacturer Route Dose Duration General Physical Health Risperdal PS UNKNOWN "high dosage" 49 MON Deterioration Risperdal SS UNKNOWN 49 MON Hyperprolactinaemia Nausea Pneumonia Respiratory Failure Sepsis Staphylococcal Infection Stem Cell Transplant Tremor Date:11/24/04ISR Number: 4509981-9Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-04P-056-0280947-00 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Norvir Soft Gelatin Initial or Prolonged Capsules PS ORAL 16 DAY Risperidone SS ORAL Zidovudine SS ORAL 16 DAY Bactrim C ORAL Buprenorphine C SUBLINGUAL Indinavir C ORAL 16 DAY Fluconazole C ORAL Olanzapine C ORAL Filgrastim C 5 DAY Kaletra Soft Gelatin Capsules C ORAL Lamivudine C ORAL Didanosine C ORAL Date:11/24/04ISR Number: 4510028-9Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20040800675 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alveolitis Risperdal PS OROPHARINGEAL Orthostatic Hypotension Cordarone C Syncope Date:11/24/04ISR Number: 4510029-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041104391 Age:8 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Congenital Anomaly Risperdal PS Other Drug Exposure During Pregnancy Date:11/24/04ISR Number: 4510030-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041002834 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumatosis Intestinalis Health Risperdal PS OROPHARINGEAL Initial or Prolonged Weight Decreased Professional Risperdal SS OROPHARINGEAL Chlorpromazine Hydrochloride SS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2346 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Levomepromazine Maleate SS OROPHARINGEAL Clostridium Butyricum C Enoprostil C Brotizolam C Mexiletine Hydrochloride C Calcium C Date:11/24/04ISR Number: 4510086-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041104072 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Aggregation Risperdal Consta PS INTRAMUSCULAR Platelet Morphology Abnormal Date:11/24/04ISR Number: 4510239-2Report Type:Expedited (15-DaCompany Report #US-ROCHE-383948 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hypoglycaemia Clonazepam PS Roche UNKNOWN Hospitalization - Multiple Drug Overdose Fentanyl SS Roche UNKNOWN Initial or Prolonged Respiratory Depression Risperidone SS UNKNOWN Unresponsive To Pain Zidovudine SS Roche UNKNOWN Stimuli Lamivudine SS UNKNOWN Progestine SS UNKNOWN Albuterol SS Roche UNKNOWN Anticonvulsant Nos SS UNKNOWN Angiotensin-Ii Receptor Antagonist SS UNKNOWN Zolpidem SS UNKNOWN Citalopram SS UNKNOWN Valdecoxib SS UNKNOWN Date:11/24/04ISR Number: 4511761-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041102397 Age:53 YR Gender:Male I/FU:I Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate Aminotransferase Increased Blood Creatine Phosphokinase Mb Increased Dehydration Drug Level Decreased Electrocardiogram Abnormal Electrocardiogram Qt Corrected Interval Prolonged Extrapyramidal Disorder Eyelid Oedema Fall 22-Feb-2006 08:20 AM Page: 2347 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hepatitis Infection Nephropathy Toxic Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Risperdal PS OROPHARINGEAL Qrs Axis Abnormal Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Quilonum Retard SS 1 tablet Quilonum Retard SS 2 tablets Quilonum Retard SS 1 tablet Quilonum Retard SS 1 tablet Ergenyl SS OROPHARINGEAL Ergenyl SS OROPHARINGEAL Ergenyl SS OROPHARINGEAL Ergenyl SS OROPHARINGEAL Ergenyl SS OROPHARINGEAL Ergenyl SS OROPHARINGEAL Ergenyl SS OROPHARINGEAL Quilonum Retard SS 2.5 tablets Quilonum Retard SS 2.5 tablets Quilonum Retard SS 1.5 tablets Quilonum Retard SS 2 tablets Haldol SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Haldol C INTRAMUSCULAR Taxilan C OROPHARINGEAL Taxilan C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Benalapril C OROPHARINGEAL Benalapril C OROPHARINGEAL Thyronajod C OROPHARINGEAL Thyronajod C OROPHARINGEAL Kalinor C 1 tablet Hydrochlorothiazide C Date:11/24/04ISR Number: 4511762-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041103323 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS OROPHARINGEAL Date:11/24/04ISR Number: 4511763-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041104401 Age:32 YR Gender:Female I/FU:I Outcome PT Death Acute Lymphocytic Leukaemia Alpha Haemolytic Streptococcal Infection Bacteraemia Blood Culture Positive Blood Pressure Decreased 22-Feb-2006 08:20 AM Page: 2348 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diabetes Mellitus Non-Insulin-Dependent Diphtheria Report Source Product Role Manufacturer Route Dose Duration Febrile Neutropenia Risperdal PS UNKNOWN "high dosage" 49 MON Hyperprolactinaemia Risperdal SS UNKNOWN 49 MON Nausea Pneumonia Respiratory Failure Respiratory Rate Increased Sepsis Staphylococcal Infection Tremor Date:11/24/04ISR Number: 4512463-1Report Type:Expedited (15-DaCompany Report #B0351194A Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Literature Combivir (Combivir) PS ORAL ORAL Phosphokinase Increased Health Fentanyl (Fentanyl) SS ORAL ORAL Blood Creatinine Professional Clonazepam Increased Other (Clonazepam) SS ORAL ORAL Coma Risperidone Drug Abuser (Risperidone) SS ORAL ORAL Drug Ineffective Ventolin (Albuterol Hypoglycaemia Sulfate) SS ORAL ORAL Kussmaul Respiration Zolpidem (Zolpidem) SS ORAL ORAL Multiple Drug Overdose Citalopram (Citalopram) SS ORAL ORAL Bextra (Bextra) SS ORAL ORAL Progesterone (Progesterone) SS ORAL ORAL Unknown (Unknown) SS ORAL ORAL Date:11/24/04ISR Number: 4514420-8Report Type:Expedited (15-DaCompany Report #B0350505A Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Chlorpromazine Initial or Prolonged Phosphokinase Increased Literature Hydrochloride (Gener Required Cellulitis Health (Chlorpromazine Intervention to Compartment Syndrome Professional Hcl) PS Prevent Permanent Oedema Peripheral Risperidone Impairment/Damage Pain In Extremity (Risperidone) SS Sensory Disturbance Venlafaxine Skin Graft Hydrochloride Tension (Venlafaxine Hydrochloride0 SS Kemadrin (Procyclidine Hcl) SS Temazepam (Temazepam) SS Antibiotics C 22-Feb-2006 08:20 AM Page: 2349 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/04ISR Number: 4511165-5Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20041006997 Age:38 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Risperdal Consta PS INTRAMUSCULAR Completed Suicide Haldol SS UNKNOWN Zuclopentixol C INTRAMUSCULAR Biperideno C UNKNOWN Date:11/26/04ISR Number: 4515324-7Report Type:Expedited (15-DaCompany Report #2004081142 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Foreign Neurontin (Tablets) Initial or Prolonged Drug Ineffective Health (Gabapentin) PS ORAL 2400 MG (600 Other Drug Interaction Professional MG), ORAL Dyslipidaemia Company Oxcarbazepine Epilepsy Representative (Oxcarbazepine) SS ORAL ORAL Hyponatraemia Risperidone Leukopenia (Risperidone) SS ORAL 2 IN 1 D, Neutropenia ORAL Noctran 10 (Acepromazine, Aceprometazine, Clorazepate Dipotassium) SS Phenobarbital Sodium (Phenobarbital Sodium) SS 100 MG Pravastatin Sodium (Pravastatin Sodium) C Ferrous Sulfate (Ferrous Sulfate) C Date:11/26/04ISR Number: 4527147-3Report Type:Periodic Company Report #04P-163-0273168-00 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Depakote Er 500mg Initial or Prolonged Depression Health (Depakote Er) Eye Movement Disorder Professional (Divalproex Sodium) Fall (Divalproex Sodium) PS ORAL 500 MG, 2 IN Intentional Overdose 1 D, ORAL Weight Increased Risperidone SS ORAL 2 MG, 1 IN 1 D, ORAL Venlafaxine Hydrochloride SS ORAL ORAL Bupropion Hydrochloride SS ORAL ORAL Strattera C Levothyroxine Sodium C Quetiapine C Date:11/29/04ISR Number: 4511875-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041103983 Age:40 YR Gender:Male I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 2350 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Leukoencephalomyelitis Risperdal PS OROPHARINGEAL Pancytopenia Retrovir SS OROPHARINGEAL Norvir SS OROPHARINGEAL Bactrim C Bactrim C Subutex C Crixivan C Triflucan C Date:11/29/04ISR Number: 4511876-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041104639 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Orthostatic Hypotension Risperdal PS OROPHARINGEAL Sinus Bradycardia Neurocil SS OROPHARINGEAL Date:11/29/04ISR Number: 4511877-3Report Type:Expedited (15-DaCompany Report #CZ-JNJFOC-20041002425 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Circulatory Collapse Risperdal Consta PS INTRAMUSCULAR treatment Drug Toxicity ongoing at time of event Risperdal SS treatment ongoing at time of event Alprazolam SS OROPHARINGEAL Alprazolam SS OROPHARINGEAL 0.5 up to 1mg daily therapy ongoing at time of event Tisercin C dose taken as needed for insomnia Date:11/29/04ISR Number: 4511878-5Report Type:Periodic Company Report #AU-JNJFOC-20041102372 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decubitus Ulcer Risperdal Consta PS INTRAMUSCULAR 43 DAY Initial or Prolonged Amisulpride SS Aripiprazole SS Date:11/29/04ISR Number: 4511879-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040903197 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Risperdal PS OROPHARINGEAL Consciousness Risperdal SS OROPHARINGEAL Diabetes Insipidus Neurontin C Polydipsia Tegretol Lp C Polyuria Ditropan C 1/2 tablet 22-Feb-2006 08:20 AM Page: 2351 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/04ISR Number: 4511880-3Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20041102546 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diarrhoea Risperdal PS Dose unknown Inflammation Tefor C OROPHARINGEAL Urinary Tract Disorder Date:11/29/04ISR Number: 4514938-8Report Type:Direct Company Report #CTU 233145 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Risperdal 1 Mg Pharyngolaryngeal Pain Janssen PS Janssen ORAL 1MG DAILY ORAL Lamictal C Dilantin C Clonazepam C Paxil Cr C Vagus Nerve Stimulator - Vns C Date:11/29/04ISR Number: 4515766-XReport Type:Expedited (15-DaCompany Report #DSA_25398_2004 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Foreign Tavor PS ORAL 2 MG Q DAY PO Initial or Prolonged Increased Health Risperdal SS ORAL 6 MG Q DAY PO Aspartate Professional Risperdal SS ORAL 7 MG Q DAY PO Aminotransferase Other Risperidone SS INTRAMUSCULAR 37.5 MG Q2WK Increased IM Blood Creatine Noctamid C Phosphokinase Increased Akineton C Blood Lactate Dehydrogenase Increased Hepatic Enzyme Increased White Blood Cell Count Decreased Date:11/29/04ISR Number: 4515770-1Report Type:Expedited (15-DaCompany Report #DSA_25396_2004 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Foreign Tavor PS SUBLINGUAL 5 MG Q DAY; Delirium Health SL Disorientation Professional Tavor SS SUBLINGUAL 5 MG Q DAY; Drug Level Decreased Other SL Speech Disorder Tavor SS SUBLINGUAL 2.5 MG Q DAY; SL Tavor SS SUBLINGUAL 10 MG Q DAY; SL Tavor SS SUBLINGUAL 5 MG Q DAY; SL Tavor SS SUBLINGUAL 7.5 MG Q DAY; SL Tavor SS SUBLINGUAL 2.5 MG Q DAY; SL Abilify SS UNKNOWN 30 MG Q DAY; Akineton SS UNKNOWN 4 MG Q DAY; 22-Feb-2006 08:20 AM Page: 2352 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Akineton SS UNKNOWN DF Abilify SS UNKNOWN 15 MG Q DAY, Akineton SS UNKNOWN 4 MG Q DAY; Nozinan SS UNKNOWN 150 MG Q DAY; Risperdal SS UNKNOWN 5 MG Q DAY; Risperdal SS UNKNOWN 3 MG Q DAY; Date:11/30/04ISR Number: 4513013-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041105494 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Renal Failure Risperdal Consta PS INTRAMUSCULAR Date:11/30/04ISR Number: 4513014-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041105503 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Disorder Risperdal Consta PS INTRAMUSCULAR Date:11/30/04ISR Number: 4513512-7Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20041105178 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Risperdal PS OROPHARINGEAL Leukocytosis Deroxat C OROPHARINGEAL Zinat C OROPHARINGEAL Date:11/30/04ISR Number: 4513513-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041105840 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperdal PS UNKNOWN Initial or Prolonged Phosphokinase Increased Chlorpromazine Other Cellulitis Hydrochloride SS UNKNOWN Compartment Syndrome Procyclidine SS UNKNOWN Skin Graft Temazepam SS UNKNOWN Venlafaxine SS UNKNOWN Date:11/30/04ISR Number: 4513514-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041106095 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Risperdal Consta PS INTRAMUSCULAR Incontinence Joint Stiffness Trismus Date:11/30/04ISR Number: 4513515-2Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20041106223 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Health Risperdal Consta PS INTRAMUSCULAR Professional Cisordinol Depot SS INTRAMUSCULAR Sinogan SS OROPHARINGEAL Akineton C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2353 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/04ISR Number: 4513516-4Report Type:Expedited (15-DaCompany Report #MK-JNJFOC-20041106522 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Risperidone PS dose: up to 3 Insulin-Dependent mg daily Ketoacidosis Risperidone SS Dose: up to 4 Treatment Noncompliance mg daily Weight Decreased Date:11/30/04ISR Number: 4513517-6Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20041105844 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Risperdal PS OROPHARINGEAL Nipple Disorder Akineton C Thrombocytopenia Date:11/30/04ISR Number: 4513754-0Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-12776902 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Drooling Modecate PS Apothecon Dyskinesia Clozapine SS Paraesthesia Oral Risperdal SS Speech Disorder Date:11/30/04ISR Number: 4518164-8Report Type:Expedited (15-DaCompany Report #A03200403818 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Increased Literature Ambien -Zolpiudem Blood Creatine Health Tartrate - Tablet - Phosphokinase Increased Professional Unit Dose: Unknown PS ORAL ORAL Coma Fentanyl - Patch - Drug Ineffective Unit Dose: Unknown SS TOPICAL TOPICAL Hypoglycaemia Clonazepam - Tablet Kussmaul Respiration - Unit Dose: Unknown SS ORAL ORAL Overdose Risperidone - Tablet - Unit Dose: Unknown SS ORAL ORAL Lamivudine/Zidovudin e - Tablet - Unit Dose: Unknown SS ORAL ORAL Citalopram - Tablet - Unit Dose: Unknown SS ORAL ORAL Valdecoxib SS Progestin - Progesterone - Tablet - Unit Dose: Unknown SS ORAL ORAL Albuterol - Aerosol - Unit Dose: Unknown SS RESPIRATORY (INHALATION) Anticonvulsant Nos - Tablet - Unit Dose: Unknown C ORAL ORAL Angiotensin Receptor Antagonis Nos - Tablet - Unit Dose: 22-Feb-2006 08:20 AM Page: 2354 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unknown C ORAL ORAL Date:12/01/04ISR Number: 4514875-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041105823 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Risperdal PS OROPHARINGEAL Date:12/01/04ISR Number: 4514876-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041106100 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Hyperprolactinaemia Depakote SS OROPHARINGEAL Disability Urinary Retention Diazepam SS OROPHARINGEAL Other Urinary Tract Infection Setraline SS OROPHARINGEAL 175-75mg Weight Increased Olanzapine C OROPHARINGEAL Lorazepam C UNKNOWN 1-4 mg PRN Oxytetracycline C UNKNOWN Date:12/01/04ISR Number: 4515105-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040607404 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brachial Plexus Lesion Risperdal PS OROPHARINGEAL Disability Convulsion Bactrim SS OROPHARINGEAL Drug Interaction Bactrim SS OROPHARINGEAL Haemodynamic Instability Mepronizine SS OROPHARINGEAL Light Chain Analysis Mepronizine SS OROPHARINGEAL Increased Cordarone SS OROPHARINGEAL Multiple Myeloma Thalidomide SS OROPHARINGEAL Myeloma Recurrence Thalidomide SS OROPHARINGEAL Nerve Root Lesion Triatec C Peripheral Sensorimotor Sporanox C Neuropathy Flecaine C Pulmonary Congestion Prozac C Pyrexia Skenan C Date:12/01/04ISR Number: 4515106-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041103983 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukoencephalomyelitis Risperdal PS OROPHARINGEAL Initial or Prolonged Pancytopenia Retrovir SS OROPHARINGEAL Other Norvir SS OROPHARINGEAL Bactrim SS OROPHARINGEAL Bactrim SS OROPHARINGEAL Subutex SS OROPHARINGEAL Crixivan SS OROPHARINGEAL Triflucan C Date:12/01/04ISR Number: 4515107-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041102118 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Risperdal PS OROPHARINGEAL Reminyl SS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2355 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel C Zoloft C Date:12/01/04ISR Number: 4515693-8Report Type:Expedited (15-DaCompany Report #FR-MERCK-0411FRA00103 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Health Crixivan PS Merck & Co., Inc ORAL 17 DAY Initial or Prolonged Professional Zidovudine SS ORAL 17 DAY Risperidone SS ORAL Ritonavir C ORAL 17 DAY Sulfamethoxazole And Trimethoprim C ORAL Buprenorphine Hydrochloride C ORAL Fluconazole C ORAL Date:12/01/04ISR Number: 4518740-2Report Type:Expedited (15-DaCompany Report #L04-USA-07403-01 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Literature Citalopram Hospitalization - Phosphokinase Increased Health (Citalopram Initial or Prolonged Blood Creatinine Professional Hydrobromide) PS Increased Fentanyl SS Coma Clonazepam SS Hypoglycaemia Risperidone SS Kussmaul Respiration Zidovudine Multiple Drug Overdose W/Lamivudine SS Respiratory Depression Progestine Unresponsive To Pain (Progesterone) SS Stimuli Anticonvulsant Nos SS Albuterol SS Angiotensin Receptor Antagonist Nos SS Zolpidem SS Valdecoxib SS Date:12/02/04ISR Number: 4516184-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040602002 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Amylase Increased Risperdal PS OROPHARINGEAL Condition Aggravated Risperdal SS OROPHARINGEAL Diabetes Mellitus Antibiotics Nos SS Hepatic Function Abnormal Mosapride Citrate C OROPHARINGEAL Hypercholesterolaemia Itopride Hyperglycaemia Hydrochloride C OROPHARINGEAL Inflammation Rilmazafone Iron Deficiency Anaemia Hydrochloride C OROPHARINGEAL Nasopharyngitis Ecabet Sodium C OROPHARINGEAL Stress Teprenone C OROPHARINGEAL Viral Infection Sodium Alginate C OROPHARINGEAL Lansoprazole C OROPHARINGEAL Promethazine Hydrochloride C OROPHARINGEAL Amezinium Metilsulfate C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2356 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amezinium Metilsulfate C OROPHARINGEAL Magnesium Oxide C OROPHARINGEAL Flavoxate Hydrochloride C OROPHARINGEAL Flavoxate Hydrochloride C OROPHARINGEAL Antibiotics C UNKNOWN Ferrous Sulfate C Date:12/02/04ISR Number: 4516597-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041008024 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Megaloblastic Risperdal PS OROPHARINGEAL Initial or Prolonged Drug Interaction Risperdal SS OROPHARINGEAL Gastritis Atrophic Nitrazepam C Haemolytic Anaemia Nitrazepam C Pernicious Anaemia Sennoside C Chlorpromazine Promethazine C Chlorpromazine Promethazine C Chlorpromazine Promethazine C Flunitrazepam C Quazepam C Date:12/02/04ISR Number: 4516598-9Report Type:Periodic Company Report #US-JNJFOC-20040801437 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:12/02/04ISR Number: 4518471-9Report Type:Expedited (15-DaCompany Report #2004UW23985 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Suicidal Ideation Study Risperidone Intervention to Health "Janssen" PS Janssen ORAL 1 MG BID PO Prevent Permanent Professional Bupropion C Impairment/Damage Ambien C Date:12/03/04ISR Number: 4517656-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041200186 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Risperdal PS OROPHARINGEAL Dyspnoea Seroquel C OROPHARINGEAL Pain In Extremity Carbatrol C OROPHARINGEAL Pulmonary Embolism Zithromax C OROPHARINGEAL Depo-Provera C INTRAMUSCULAR 22-Feb-2006 08:20 AM Page: 2357 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/04ISR Number: 4517657-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041003910 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Aminotransferase Risperdal Consta SS INTRAMUSCULAR Other Increased Temesta C Blood Creatine Akineton Retard C Phosphokinase Increased Mopral C Blood Creatinine Tegretol C Increased Sulfarlem C Electroencephalogram Abnormal Grand Mal Convulsion Iatrogenic Injury Myoglobin Blood Increased Red Blood Cell Sedimentation Rate Increased Date:12/03/04ISR Number: 4517658-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040906352 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS UNKNOWN Date:12/03/04ISR Number: 4517659-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040901777 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dialysis Risperdal PS OROPHARINGEAL Hallucination Helicobacter Infection Date:12/03/04ISR Number: 4517660-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041008685 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperdal PS OROPHARINGEAL Mianserin Hydrochloride C Levomepromazine Maleate C Date:12/03/04ISR Number: 4517661-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041008684 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperdal PS OROPHARINGEAL Risperdal SS OROPHARINGEAL Tiapride Hydrochloride C Sodium Valproate C Zolpidem Tartrate C 22-Feb-2006 08:20 AM Page: 2358 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/04ISR Number: 4517663-2Report Type:Expedited (15-DaCompany Report #BR-JNJFOC-20041200053 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Haldol PS OROPHARINGEAL Initial or Prolonged Dementia Alzheimer'S Type Haldol SS OROPHARINGEAL Hypertension Risperidone SS Increased Appetite Fenergan C Salivary Hypersecretion Urinary Incontinence Date:12/03/04ISR Number: 4518025-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041106871 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Risperdal PS OROPHARINGEAL Haemoglobin Decreased Oren-Gedoku-To C OROPHARINGEAL Red Blood Cell Count Oren-Gedoku-To C OROPHARINGEAL Decreased Oren-Gedoku-To C OROPHARINGEAL White Blood Cell Count Estazolam C OROPHARINGEAL Decreased Flurazepam Hydrochloride C OROPHARINGEAL Promethazine Hydrochloride C OROPHARINGEAL Trihexyphenidyl Hydrochloride C OROPHARINGEAL Ecabet Sodium C OROPHARINGEAL Rilmazafone Hydrochloride C OROPHARINGEAL Date:12/03/04ISR Number: 4518327-1Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-04P-056-0280947-00 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Norvir Soft Gelatin Initial or Prolonged Capsules PS ORAL 16 DAY Risperidone SS ORAL Zidovudine SS ORAL 16 DAY Bactrim SS ORAL Buprenorphine SS SUBLINGUAL Indinavir SS ORAL 16 DAY Fluconazole C ORAL Olanzapine C ORAL Filgrastim C 5 DAY Kaletra Soft Gelatin Capsules C ORAL Lamivudine C ORAL Didanosine C ORAL Date:12/03/04ISR Number: 4518968-1Report Type:Direct Company Report #CTU 233632 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compartment Syndrome Lipitor Parke Initial or Prolonged Nerve Compression Davis PS Parke Davis ORAL DAILY ORAL Rhabdomyolysis Risperdal Janssen SS Janssen ORAL 6 MG DAILY ORAL Metformin C Lisinopril C 22-Feb-2006 08:20 AM Page: 2359 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Naltrexone C Aspirin C Micronase C Trazadone C Clonazepam C Date:12/06/04ISR Number: 4519125-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041200407 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal PS OROPHARINGEAL Risperdal SS OROPHARINGEAL Lipitor C OROPHARINGEAL Micardis C OROPHARINGEAL Acetylsalicylic Acid C OROPHARINGEAL Plavix C OROPHARINGEAL Date:12/06/04ISR Number: 4519126-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041200421 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Congestive Risperdal Consta SS INTRAMUSCULAR Death Risperdal Consta SS INTRAMUSCULAR Treatment Noncompliance Date:12/06/04ISR Number: 4519127-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041200490 Age:50 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Personality Change Risperdal PS OROPHARINGEAL Initial or Prolonged Olanzapine SS OROPHARINGEAL 10- 15 mg Disability daily dose Other Zoplicone C OROPHARINGEAL Bendrofluazide C OROPHARINGEAL Date:12/06/04ISR Number: 4519128-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041200531 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Thrombotic Risperdal PS OROPHARINGEAL Thrombocytopenic Purpura Date:12/06/04ISR Number: 4520910-4Report Type:Expedited (15-DaCompany Report #L04-USA-07403-28 Age:58 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Citalopram PS Multiple Drug Overdose Health Risperidone Professional (Risperidone) SS Methylphenidate SS 22-Feb-2006 08:20 AM Page: 2360 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/06/04ISR Number: 4521631-4Report Type:Expedited (15-DaCompany Report #L04-USA-07403-25 Age:31 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Citalopram PS Multiple Drug Overdose Health Alprazolam SS Intentional Professional Risperidone (Risperidone) SS Date:12/06/04ISR Number: 4522097-0Report Type:Expedited (15-DaCompany Report #2004243359JP Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bipolar I Disorder Foreign Cabaser Dehydration Health (Cabergoline) PS ORAL 0.5 MG (0.5 Neuroleptic Malignant Professional MG) ORAL Syndrome Pergolide Mesilate Parkinson'S Disease (Pergolide Mesilate) SS ORAL 500 MCG, ORAL Risperidone (Risperidone) SS ORAL ORAL Zotepine (Zotepine) SS ORAL ORAL Levomepromazine Maleate (Levomepromazine Maleate) SS ORAL 50 MG (50 MG), ORAL Valproate Sodium (Valproate Sodium) C Lithium Carbonate (Lithium Carbonate) C Date:12/06/04ISR Number: 4532968-7Report Type:Periodic Company Report #USA041080681 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Health Cymbalta (Duloxetine Tremor Professional Hydrochloride) PS 60 MG DAY Company Risperdal Representative (Risperidone) SS Ativan (Lorazepam) C Ambien (Zolpidem Tartrate) C Aricept (Donepezil Hydrochloride) C Date:12/07/04ISR Number: 4519813-0Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20041106169 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperdal PS OROPHARINGEAL Initial or Prolonged Phosphokinase Increased Tarivid SS Chest Pain Librax C OROPHARINGEAL Drug Interaction Librax C OROPHARINGEAL 1 tab/day Fatigue Enatec C OROPHARINGEAL Semap C Semap C 22-Feb-2006 08:20 AM Page: 2361 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/04ISR Number: 4520019-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041106869 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Risperdal PS OROPHARINGEAL Other Leukopenia Antihypertensives C White Blood Cell Count Decreased Date:12/07/04ISR Number: 4522603-6Report Type:Expedited (15-DaCompany Report #2004075203 Age:38 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pelvic Venous Thrombosis Foreign Neurontin Other Pulmonary Embolism Health (Gabapentin) PS ORAL 600 MG (300 Professional MG, 2 IN 1 D), ORAL Risperidone (Risperidone) SS ORAL 5 MG (1D), ORAL Diazepam (Diazepam) SS ORAL 40 DROP (20 DROP, 2 IN 1 D), ORAL Hydromorphone Hydrochloride (Hydromorphone Hydrochloride) SS ORAL 4 MG (2 MG, 2 IN 1 D), ORAL Date:12/07/04ISR Number: 4522824-2Report Type:Expedited (15-DaCompany Report #HQWYE972010JUL04 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchial Obstruction Health Cordarone Initial or Prolonged Haemodynamic Instability Professional (Amiodarone, Tablet) PS ORAL 200 MG 1X PER Disability Peripheral Motor Other 1 DAY ORAL Neuropathy Bactrim Peripheral Sensory (Sulfamethoxazole/Tr Neuropathy imethoprim, ) SS ORAL 400 MG 1X PER Status Epilepticus 1 DAY ORAL Mepronizine (Aceprometazine/Mepr obamate, ) SS ORAL 820 MG 1X PER 1 DAY ORAL Risperdal (Risperidone, ) SS ORAL 4 MG 1X PER 1 DAY ORAL Thalidomide (Thalidomide, ) SS ORAL 100 MG 1X PER 1 DAY ORAL Thalidomide (Thalidomide, ) SS ORAL ORAL Triatec (Ramipril) C Sporanox (Itraconazole) C Flecaine (Flecainide Acetate) C Prozac (Fluoxetine Hydrochloride) C Skenan (Morphine 22-Feb-2006 08:20 AM Page: 2362 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sulfate) C Date:12/08/04ISR Number: 4521238-9Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040907351 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Risperdal Consta PS INTRAMUSCULAR 6 MON Squamous Cell Carcinoma Sodium Valproate C OROPHARINGEAL Lamotrigine C OROPHARINGEAL Date:12/08/04ISR Number: 4523231-9Report Type:Expedited (15-DaCompany Report #2004CG02432 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Acute Foreign Nexium PS Initial or Prolonged Rhabdomyolysis Health Zestril SS Professional Equanil SS Other Risperdal SS Kardegic /Fra/ SS Lovenox SS Date:12/08/04ISR Number: 4523845-6Report Type:Direct Company Report #CTU 233921 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal Consta 50 Mg PS INTRAMUSCULAR 50 MG IM Q 2 WEEKS Depakote Er C Klonopin C Abilify C Trazadone C Date:12/09/04ISR Number: 4521814-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041200936 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Acute Risperdal PS OROPHARINGEAL Initial or Prolonged Drug Interaction Olanzapine SS OROPHARINGEAL 15-20 Neuroleptic Malignant mg/daily Syndrome Date:12/09/04ISR Number: 4522354-8Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-B0314536A Age:30 YR Gender:Male I/FU:F Outcome PT Hospitalization - Cerebral Atrophy Initial or Prolonged Confusional State Delirium Delusion Hallucination Hallucination, Auditory Hypertension Hyperthermia Insomnia Muscle Contractions Involuntary 22-Feb-2006 08:20 AM Page: 2363 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Rigidity Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Speech Disorder Lithium PS Glaxosmithkline 450MG Twice Tachycardia per day Tremor Risperidone SS UNKNOWN Olanzapine C UNKNOWN Divalproex C Date:12/09/04ISR Number: 4523930-9Report Type:Expedited (15-DaCompany Report #SUS1-2004-00783 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Carbatrol Cough Professional (Carbamazepine) Xr PS 300 MG, EVERY Dizziness 12 HOURS, Feeling Abnormal Seroquel (Quetiapine Loss Of Consciousness Fumarate) SS 200 MG, EVERY Pain In Extremity HS, Pulmonary Embolism Risperdal Treatment Noncompliance (Risperidone) SS 1 MG, 1X/DAY; QD IN AM, Depo Provera (Medroxyprogesterone Acetate) C Date:12/09/04ISR Number: 4524073-0Report Type:Expedited (15-DaCompany Report #GXKR2004GB00458 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Diazepam (Ngx) Initial or Prolonged Hyperprolactinaemia Health (Diazepam) PS ORAL 10 MG, BID, Disability Urinary Retention Professional ORAL Other Urinary Tract Infection Other Depakote (Valproate Weight Increased Semisodium) SS ORAL ORAL Sertraline (Sertraline) SS ORAL 175 - 75 MG, ORAL Risperdal (Risperidone) SS INTRAMUSCULAR 37.5 MG, BIW, INTRAMUSCULAR Olanzapine (Olanzapine) C Lorazepam (Lorazepam) C Oxytertracycline C Topicycline (Tetracycline Hydrochloride) C Date:12/10/04ISR Number: 4523164-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041200355 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS OROPHARINGEAL Lung Infection Neutropenia 22-Feb-2006 08:20 AM Page: 2364 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/04ISR Number: 4523165-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041003910 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Aminotransferase Risperdal Consta SS INTRAMUSCULAR Other Increased Temesta C Blood Creatine Akineton Retard C Phosphokinase Increased Mopral C Electroencephalogram Tegretol C Abnormal Sulfarlem C Epilepsy Grand Mal Convulsion Iatrogenic Injury Myoglobin Blood Increased Date:12/10/04ISR Number: 4523166-1Report Type:Periodic Company Report #US-JNJFOC-20041006580 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Risperdal PS OROPHARINGEAL Hospitalization - Anorexia Nervosa Potassium C Initial or Prolonged Ascites Librax C Dehydration Librax C Electrolyte Imbalance Pancrease Mt 10 C Hypoxia Pancrease Mt 10 C Malnutrition Pancrease Mt 10 C Non-Cardiac Chest Pain Neurontin C Pleural Effusion Multivitamins C Renal Cell Carcinoma Multivitamins C Stage Unspecified Multivitamins C Weight Decreased Multivitamins C Multivitamins C Multivitamins C Multivitamins C Multivitamins C Vitamin E C Zinc 220 C Darvocet N-100 C Darvocet N-100 C Date:12/10/04ISR Number: 4523315-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041200939 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal PS OROPHARINGEAL Phosphokinase Increased Risperdal SS OROPHARINGEAL Catatonia Flunitrazepam C OROPHARINGEAL Hallucination Sulpiride C OROPHARINGEAL Incoherent Chinese Medicines C Petit Mal Epilepsy Pollakiuria Tremor 22-Feb-2006 08:20 AM Page: 2365 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/04ISR Number: 4523316-7Report Type:Periodic Company Report #US-JNJFOC-20040902335 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Risperdal SS OROPHARINGEAL Date:12/10/04ISR Number: 4525646-1Report Type:Expedited (15-DaCompany Report #GXKR2004GB00458 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Foreign Diazepam (Ngx) Initial or Prolonged Hyperprolactinaemia Health (Diazepam) PS ORAL 10 MG, BID, Disability Urinary Retention Professional ORAL Other Urinary Tract Infection Other Depakote (Valproate Weight Increased Semisodium) SS ORAL ORAL Sertraline (Sertraline) SS ORAL 175 - 75 MG, ORAL Risperdal (Risperidone) SS INTRAMUSCULAR 37.5 MG, BIW, INTRAMUSCULAR Olanzapine (Olanzapine) C Lorazepam (Lorazepam) C Oxytetracycline (Oxytetracycline) C Topicycline (Tetracycline Hydrochloride) C Date:12/10/04ISR Number: 4526380-4Report Type:Expedited (15-DaCompany Report #GBWYE261807DEC04 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Benzhexol Drug Exposure During Health (Trihexyphenidyl, Pregnancy Professional Tablet, 0) PS ORAL 2MG ORAL Ultrasound Antenatal Other Risperidone Screen Abnormal (Risperidone, ,0) SS ORAL 2MG ORAL Date:12/13/04ISR Number: 4524726-4Report Type:Expedited (15-DaCompany Report #FR-RB-1173-2004 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Buprenorphine Initial or Prolonged Hydrochloride PS SUBLINGUAL Bactrim SS ORAL 1 DOSE DAILY Risperidone SS ORAL UNKNOWN Zidovudine SS ORAL UNKNOWN Indinavir Sulfate SS ORAL Ritonavir SS ORAL Fluconazole C UNKNOWN UNKNOWN 22-Feb-2006 08:20 AM Page: 2366 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/04ISR Number: 4524750-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041201310 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Risperdal PS OROPHARINGEAL Drug Exposure During Trihexyphenidyl SS OROPHARINGEAL Pregnancy Date:12/13/04ISR Number: 4524751-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040501364 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal PS OROPHARINGEAL 15 MON Decreased Appetite Delusion Depression Diarrhoea Disturbance In Attention Galactorrhoea Gastric Polyps Hallucination Headache Hepatic Lesion Infertility Insomnia Malaise Panic Attack Paranoia Pituitary Tumour Benign Visual Disturbance Weight Decreased Date:12/13/04ISR Number: 4525324-9Report Type:Expedited (15-DaCompany Report #200414561FR Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Lovenox PS Aventis Initial or Prolonged Condition Aggravated Pharmaceuticals Inc. SUBCUTANEOUS Renal Failure Equanil SS ORAL Rhabdomyolysis Risperdal SS ORAL Kardegic SS ORAL Zestril SS ORAL Inexium SS ORAL Date:12/14/04ISR Number: 4526579-7Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20041200465 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Risperdal PS OROPHARINGEAL Rivotril C OROPHARINGEAL Rivotril C OROPHARINGEAL Priadel C OROPHARINGEAL 800-0-400 mg/day Aspirin C OROPHARINGEAL Aspirin C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2367 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/04ISR Number: 4526580-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041201664 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Risperdal PS OROPHARINGEAL Crying Unresponsive To Verbal Stimuli Date:12/14/04ISR Number: 4526581-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041007451 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Risperdal Consta PS INTRAMUSCULAR Truxal C Date:12/14/04ISR Number: 4526582-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041105096 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Risperdal PS OROPHARINGEAL the patient Initial or Prolonged Overdose took 25 tablets at one time Date:12/14/04ISR Number: 4526583-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040702326 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Risperdal PS White Blood Cell Count Risperdal SS Decreased Lorazepam C Biperiden Hydrochloride C Chlorpromazine Tannate C Chlorpromazine Tannate C Chlorpromazine Tannate C Chlorpromazine Tannate C Chlorpromazine Tannate C Chlorpromazine Tannate C Chlorpromazine Tannate C Chlorpromazine Tannate C Brotizolam C Brotizolam C Brotizolam C 22-Feb-2006 08:20 AM Page: 2368 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/04ISR Number: 4526585-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040702328 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Risperdal PS OROPHARINGEAL Constipation Risperdal SS OROPHARINGEAL Extrapyramidal Disorder Risperdal SS OROPHARINGEAL Leukopenia Risperdal SS OROPHARINGEAL Muscle Rigidity Risperdal SS OROPHARINGEAL Thirst Risperdal SS OROPHARINGEAL Tremor Risperdal SS OROPHARINGEAL Weight Increased Flunitrazepam C OROPHARINGEAL Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Etizolam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Olanzapine C OROPHARINGEAL 51 DAY Olanzapine C OROPHARINGEAL 51 DAY Quazepam C OROPHARINGEAL 56 DAY Quazepam C OROPHARINGEAL 56 DAY Quazepam C OROPHARINGEAL 56 DAY Quazepam C OROPHARINGEAL 56 DAY Sennoside C Sennoside C Brotizolam C Brotizolam C Magnesium Oxide C Magnesium Oxide C Magnesium Oxide C Date:12/14/04ISR Number: 4526586-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040701116 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Risperdal PS OROPHARINGEAL Sennoside C OROPHARINGEAL Flunitrazepam C OROPHARINGEAL Sodium Valproate C OROPHARINGEAL Date:12/14/04ISR Number: 4527330-7Report Type:Direct Company Report #CTU 234288 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Abnormal Behaviour Celexa 30 Mg PS ORAL 30 MG 1 X A Intervention to Aggression DAY ORAL Prevent Permanent Crying Risperdol 1.5 SS ORAL 1.5 MG 2X A Impairment/Damage Psychotic Disorder DAY ORAL Self Injurious Behaviour 22-Feb-2006 08:20 AM Page: 2369 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/04ISR Number: 4527806-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041201303 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Renal Failure Risperdal PS OROPHARINGEAL Initial or Prolonged Rhabdomyolysis Equanil SS Kardegic SS Zestril SS Lovenox SS Inexium SS Date:12/15/04ISR Number: 4527808-6Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20041201306 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholestasis Haldol PS OROPHARINGEAL Initial or Prolonged Hepatitis Cholestatic Risperdal SS OROPHARINGEAL Citalopram Aco SS OROPHARINGEAL Oxascand C Heminevrin C Seloken C Movicol C OROPHARINGEAL Movicol C OROPHARINGEAL Movicol C OROPHARINGEAL Movicol C OROPHARINGEAL Trombyl C Zopiklon C Date:12/15/04ISR Number: 4527809-8Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20041006997 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Risperdal Consta PS INTRAMUSCULAR Haldol SS UNKNOWN Zuclopentixol C INTRAMUSCULAR Biperideno C UNKNOWN Date:12/15/04ISR Number: 4527821-9Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20041202809 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Risperdal PS OROPHARINGEAL Other Neutropenia Risperdal Consta SS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Olanzapine SS 8 DAY Chlorpromazine C Date:12/15/04ISR Number: 4527822-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040902881 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Risperdal PS OROPHARINGEAL Iron Supplement C Coumadin C Coumadin C Lasix C Ativan C Nexium C 22-Feb-2006 08:20 AM Page: 2370 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aricept C Lexapro C 1/2 of a 20 mg dose. Tylenol C Date:12/15/04ISR Number: 4528982-8Report Type:Direct Company Report #CTU 234352 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Risperdal PS ORAL 0.25 - 0.5 Hospitalization - Bradycardia MG, BID, PO Initial or Prolonged Conjunctivitis Hypoglycaemia Hypotension Oxygen Saturation Decreased Pain Pancytopenia Respiratory Tract Infection Date:12/16/04ISR Number: 4528636-8Report Type:Expedited (15-DaCompany Report #FR-MERCK-0409FRA00072 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Zocor PS Merck & Co., Inc ORAL Initial or Prolonged Dysstasia Fluoxetine Disability Fall Hydrochloride SS ORAL Neuropathy Risperidone SS ORAL Rhabdomyolysis Acepromazine And Aceprometazine And Clorazepate Dipotassium SS ORAL Zopiclone SS ORAL Levothyroxine Sodium C ORAL Date:12/17/04ISR Number: 4529994-0Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20041201667 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal Consta PS INTRAMUSCULAR Risperdal SS Date:12/17/04ISR Number: 4529995-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040701114 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal PS OROPHARINGEAL Phosphokinase Increased Flunitrazepam C OROPHARINGEAL Excitability Teprenone C OROPHARINGEAL Haemoglobin Decreased Lorazepam C OROPHARINGEAL Lansoprazole C OROPHARINGEAL Lithium Carbonate C OROPHARINGEAL Levomepromazine Maleate C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2371 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fk C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL Date:12/17/04ISR Number: 4529996-4Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20040800675 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Alveolitis Risperdal PS OROPHARINGEAL Bronchitis Cordarone C Orthostatic Hypotension Ebixa C Syncope Date:12/17/04ISR Number: 4529997-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041101067 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Tardive Dyskinesia Tetrabenazine C Tetrabenazine C Cipramil C Date:12/17/04ISR Number: 4529998-8Report Type:Periodic Company Report #US-JNJFOC-20040809762 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Risperdal PS UNKNOWN Pulmonary Disease Date:12/17/04ISR Number: 4529999-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041004498 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infarction Risperdal PS OROPHARINGEAL Date:12/17/04ISR Number: 4530000-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041003702 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Risperdal PS OROPHARINGEAL Oestrogen Receptor Assay Risperdal SS OROPHARINGEAL Positive Zoloft C Progesterone Receptor Accupril C Assay Positive Xanax C Date:12/17/04ISR Number: 4530001-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041200936 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Cardiac Failure Acute Initial or Prolonged Drug Interaction Neuroleptic Malignant 22-Feb-2006 08:20 AM Page: 2372 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Report Source Product Role Manufacturer Route Dose Duration Risperdal PS OROPHARINGEAL Olanzapine SS OROPHARINGEAL 15-20 mg/daily Date:12/17/04ISR Number: 4530002-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040804627 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal Consta PS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Risperidone SS Risperidone SS Olanzapine SS OROPHARINGEAL Lithium C OROPHARINGEAL 900 mg AM 600 mg PM Fluoxetine C OROPHARINGEAL Levothyroid C OROPHARINGEAL Pepcid C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Oxazepam C as needed Date:12/17/04ISR Number: 4530109-3Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-04P-167-0282738-00 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Constipation Depakote PS ORAL Initial or Prolonged Hyperprolactinaemia Diazepam SS ORAL 40 DAY Urinary Retention Sertraline SS ORAL Urinary Tract Infection Risperidone SS INTRAMUSCULAR 128 DAY Weight Increased Risperidone SS UNKNOWN 128 DAY Olanzapine C ORAL Lorazepam C UNKNOWN 1-4 mg daily Lorazepam C Oxytetracycline C UNKNOWN Date:12/17/04ISR Number: 4530130-5Report Type:Expedited (15-DaCompany Report #NZ-JNJFOC-20041202104 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Risperdal PS UNKNOWN Urinary Bladder Rupture Clomipramine C Urinary Retention Fluphanzine C 22-Feb-2006 08:20 AM Page: 2373 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/17/04ISR Number: 4530131-7Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040303131 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Risperdal PS Initial or Prolonged Extrapyramidal Disorder Dexamethasone C Other Medical Device Complication Date:12/20/04ISR Number: 4532148-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041202830 Age:19 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Other Date:12/20/04ISR Number: 4532149-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041203062 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Risperdal PS OROPHARINGEAL Abnormal Behaviour Risperdal SS OROPHARINGEAL Blood Glucose Increased Lithium Carbonate C OROPHARINGEAL Blood Prolactin Increased Topamax C OROPHARINGEAL Depression Tegretol C OROPHARINGEAL Diarrhoea Fatigue Glossodynia Mood Altered Pituitary Tumour Pollakiuria Tardive Dyskinesia Thirst Date:12/20/04ISR Number: 4532150-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041203147 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspepsia Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Hospitalisation Risperdal Consta SS INTRAMUSCULAR Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Depakote C OROPHARINGEAL Cogentin C OROPHARINGEAL Ativan C OROPHARINGEAL Date:12/20/04ISR Number: 4532151-5Report Type:Periodic Company Report #US-JNJFOC-20040902332 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cachexia Risperdal PS OROPHARINGEAL Cardiac Failure Congestive Failure To Thrive Pneumonia Aspiration 22-Feb-2006 08:20 AM Page: 2374 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/04ISR Number: 4532152-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040809752 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Prostate Cancer Health Risperdal PS UNKNOWN Metastatic Professional Reminyl SS Date:12/20/04ISR Number: 4532153-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041200939 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Health Risperdal PS OROPHARINGEAL Phosphokinase Increased Professional Risperdal SS OROPHARINGEAL Catatonia Flunitrazepam C OROPHARINGEAL Hallucination Sulpiride C OROPHARINGEAL Hallucination, Visual Chinese Medicines C Incoherent Atorvastatin Calcium C Myoglobin Blood Increased Petit Mal Epilepsy Pollakiuria Rhabdomyolysis Syncope Tremor Date:12/20/04ISR Number: 4532154-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041003910 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Health Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Aminotransferase Professional Risperdal Consta SS INTRAMUSCULAR Other Increased Temesta C Blood Creatine Akineton Retard C Phosphokinase Increased Mopral C Grand Mal Convulsion Tegretol C Myoglobin Blood Increased Sulfarlem C Date:12/20/04ISR Number: 4532260-0Report Type:Expedited (15-DaCompany Report #CA-ABBOTT-04P-028-0272719-00 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Bilirubin Increased Epival Tablets PS ORAL Initial or Prolonged Cholelithiasis Epival Tablets SS ORAL Condition Aggravated Epival Tablets SS Hepatic Enzyme Increased Ritonavir Soft Hepatotoxicity Gelatin Capsules SS ORAL 786 DAY Hypomania Ritonavir Soft Jaundice Cholestatic Gelatin Capsules SS ORAL 786 DAY Nausea Tipranavir SS ORAL 787 DAY Pneumonia Procyclidine SS ORAL 151 DAY Psychotic Disorder Olanzapine SS ORAL 3 YR Schizophrenia Olanzapine SS ORAL 3 YR Vomiting Risperidone SS ORAL 46 DAY Trazodone SS ORAL Trazodone SS ORAL Quetiapine SS ORAL 23 DAY Clonazepam SS ORAL Carbamazepine SS 9 DAY Paracetamol SS ORAL 642 DAY Paracetamol SS 642 DAY 22-Feb-2006 08:20 AM Page: 2375 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lamivudine C ORAL 128 DAY Lamivudine C 128 DAY Abacavir C ORAL 128 DAY Abacavir C 128 DAY Atovaquone C ORAL 154 DAY Atovaquone C 154 DAY Calcium Carbonate C ORAL 4 YR Magic Mouthwash C 204 DAY Nystatin C ORAL 12 YR Megavim C ORAL Enfuvirtide (T-20) C SUBCUTANEOUS Enfuvirtide (T-20) C Bisacodyl C Bisacodyl C Choral Hydrate C Lactulose C 209 DAY Imodium C 4 YR Diphenhydramine Hydrochloride C INTRAVENOUS Diphenhydramine Hydrochloride C ORAL Diphenhydramine Hydrochloride C INTRAMUSCULAR Kaletra C 3 DAY Lithium C 4 DAY Date:12/20/04ISR Number: 4535923-6Report Type:Expedited (15-DaCompany Report #A03200403818 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Literature Ambien PS ORAL ORAL Phosphokinase Increased Health Fentanyl -Patch SS TOPICAL TOPICAL Blood Creatinine Professional Clonazepam Tablet SS ORAL ORAL Increased Risperidone Tablet SS ORAL ORAL Coma Lamivudine/Zidovudin Drug Abuser e Tablet SS ORAL ORAL Drug Ineffective Progestin Hypoglycaemia Progesterone Tablet SS ORAL ORAL Intentional Misuse Albuterol Aerosol SS RESPIRATORY Kussmaul Respiration (INHALATION) Overdose Anticonvulsant Nos Tablet SS ORAL ORAL Angiotensin Receptor Antagonist Nos Tablet SS ORAL ORAL Citalopram Tablet SS ORAL ORAL Valdecoxib SS Glyburide C Date:12/20/04ISR Number: 4536997-9Report Type:Expedited (15-DaCompany Report #2004-123367-NL Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pulmonary Embolism Foreign Mirtazapine PS ORAL 1 DF QD ORAL Initial or Prolonged Health Risperidone SS ORAL 1 MG/2 MG Professional ORAL 2 WK 22-Feb-2006 08:20 AM Page: 2376 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/04ISR Number: 4554359-5Report Type:Periodic Company Report #04-07-1052 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Health Clozapine Tablets - Drug Ineffective Professional Ivax Drug Level Increased Other Pharmaceuticals, Hyperlipidaemia Inc. PS Ivax Weight Increased Pharmaceuticals, Inc. ORAL 300-600 MG QD ORAL Risperdal Unknown SS 4MG BID Trazodone C Effexor Xr C Neurontin C Date:12/21/04ISR Number: 4533592-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040606650 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal PS OROPHARINGEAL 14 DAY Leukopenia Nitrazepam C OROPHARINGEAL Thrombocytopenia Diazepam C OROPHARINGEAL Sulpride C OROPHARINGEAL Perospirone C Olanzapine C Date:12/21/04ISR Number: 4533593-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040704586 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Risperdal PS OROPHARINGEAL Anaemia Risperdal SS OROPHARINGEAL Blood Amylase Increased Risperdal SS OROPHARINGEAL Hyperlipidaemia Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Propranolol Hydrochloride C OROPHARINGEAL Tandospirone Citrate C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2377 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tandospirone Citrate C OROPHARINGEAL Date:12/21/04ISR Number: 4533594-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041200936 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Risperdal PS OROPHARINGEAL Hospitalization - Blood Pressure Increased Risperdal SS OROPHARINGEAL Initial or Prolonged Blood Test Abnormal Halomonth SS Cachexia Olanzapine SS OROPHARINGEAL Cardiac Failure Acute Olanzapine SS OROPHARINGEAL Dehydration Cimetidine C Delusion Biperiden Diet Refusal Hydrochloride C Dyspnoea Isoleucine Leucine Eye Disorder Valine C Haematemesis Flunitrazepam C Hepatic Cirrhosis Zopiclone C Hyperhidrosis Sennoside C Hypoxia Aspartate Potassium C Loss Of Consciousness Neuroleptic Malignant Syndrome Pulmonary Oedema Respiratory Arrest Tremor Wheezing Date:12/21/04ISR Number: 4537903-3Report Type:Expedited (15-DaCompany Report #MK200412-0173-1 Age:58 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Methylphenidate Hcl PS Usp Multiple Drug Overdose Health Citalopram SS Intentional Professional Risperidone SS Date:12/22/04ISR Number: 4534417-1Report Type:Expedited (15-DaCompany Report #JP-SOLVAY-00304004218 Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Luvox 25 PS ORAL Daily dose: Initial or Prolonged Convulsion 75 Drug Interaction milligram(s) 2 YR Nasopharyngitis General Cold Serotonin Syndrome Medication I UNKNOWN Daily dose: Tremor unknown Risperidone I ORAL Daily dose: 3 milligram(s) 2 YR Paroxetine Hydrochloride Hydrate I ORAL Daily dose: 40 milligram(s) 2 YR Paroxetine Hydrochloride Hydrate I ORAL Daily dose: 10 milligram(s) 27 DAY 22-Feb-2006 08:20 AM Page: 2378 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/04ISR Number: 4534548-6Report Type:Expedited (15-DaCompany Report #EMADSS2003002298 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS OROPHARINGEAL Pyrexia Date:12/22/04ISR Number: 4534549-8Report Type:Expedited (15-DaCompany Report #EMADSS2002002643 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS OROPHARINGEAL 3 YR Viral Infection Sodium Valproate C UNKNOWN Date:12/22/04ISR Number: 4535347-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041203334 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Risperdal PS Prothrombin Time Marcumar I OROPHARINGEAL Prolonged Date:12/22/04ISR Number: 4535348-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041204453 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Benign Risperdal PS OROPHARINGEAL Quetiapine Fumarate C OROPHARINGEAL Date:12/22/04ISR Number: 4535349-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041204501 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Stevens-Johnson Syndrome Risperdal Consta PS INTRAMUSCULAR Date:12/22/04ISR Number: 4535350-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041000039 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Risperdal PS OROPHARINGEAL Initial or Prolonged Infection Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Tercian C Athymil C Seresta C Depakote C Stilnox C Nicobion C Novonorm C Glucophage C Insulin Mixtard C 22-Feb-2006 08:20 AM Page: 2379 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/22/04ISR Number: 4535649-9Report Type:Direct Company Report #CTU 234908 E Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Abilify PS PLUS Hospitalization - Prescribed Overdose INJECTIONS 2 Initial or Prolonged Suicide Attempt X A DAY Disability Tooth Disorder 2001-2004 Other Zyprexa 40 Mg SS 3 X DAY Required 10/04-PRES Intervention to Risperdal 13 Mg SS Prevent Permanent Prolaxian 20 Mg SS Impairment/Damage Depakote 2500 SS Seraquel 800 Mg SS Cogentin 4 Mg SS Others SS Date:12/22/04ISR Number: 4536595-7Report Type:Direct Company Report #CTU 234948 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Risperdal Janssen PS Janssen ORAL 2.5 MG DAILY ORAL Effexor Xr C Adderall Xr C Date:12/23/04ISR Number: 4536489-7Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20041204127 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysarthria Risperdal PS Hemiparesis Risperdal SS Transient Ischaemic Attack Date:12/23/04ISR Number: 4536490-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041204233 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Cancer Risperdal PS Hospitalization - Initial or Prolonged Other Date:12/23/04ISR Number: 4536491-5Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20041204493 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Fractures Risperdal Consta PS INTRAMUSCULAR Date:12/23/04ISR Number: 4536492-7Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20041204496 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Risperdal Consta PS INTRAMUSCULAR General Physical Health Risperdal Consta SS INTRAMUSCULAR Deterioration 22-Feb-2006 08:20 AM Page: 2380 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/04ISR Number: 4536493-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041100011 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Risperdal PS OROPHARINGEAL Other Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Novodigal C Dytide C Dytide C Tavor C Date:12/23/04ISR Number: 4536494-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041002799 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Risperdal PS OROPHARINGEAL in AM and @hs Haemoglobin Decreased Risperdal SS OROPHARINGEAL @hs Metroprolol C Lipitor C Ferrous Sulfate C Premarin C Provera C Cerovite C Cerovite C Cerovite C Cerovite C Cerovite C Date:12/23/04ISR Number: 4536495-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040902890 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Risperdal PS OROPHARINGEAL Exelon C Date:12/23/04ISR Number: 4536727-0Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20041104816 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Risperdal PS OROPHARINGEAL Supraventricular Tachycardia Date:12/23/04ISR Number: 4536728-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041204508 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cataract Risperdal PS Date:12/23/04ISR Number: 4536729-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041204639 Age:70 YR Gender:Female I/FU:I Outcome PT Other C-Reactive Protein Increased Cogwheel Rigidity 22-Feb-2006 08:20 AM Page: 2381 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report General Physical Health Deterioration Hyperthermia Report Source Product Role Manufacturer Route Dose Duration Risperdal PS OROPHARINGEAL Date:12/23/04ISR Number: 4536730-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041106215 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Blood Creatine Risperdal PS OROPHARINGEAL Other Phosphokinase Increased Plaquenil C Myalgia Celebrex C Neuromuscular Blockade Pariet C Dafalgan C Xanax C Deroxat C Date:12/23/04ISR Number: 4536731-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041008034 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Risperdal PS OROPHARINGEAL Initial or Prolonged Consciousness Risperdal SS OROPHARINGEAL Other Dyskinesia Eating Disorder Headache Date:12/23/04ISR Number: 4536732-4Report Type:Periodic Company Report #US-JNJFOC-20040906352 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Risperdal PS UNKNOWN Blood Prolactin Increased Risperdal SS UNKNOWN Death Risperdal SS UNKNOWN 4 mg am and 2 Depression mg pm Drug Ineffective Risperdal SS UNKNOWN Insomnia Zyprexa C Therapeutic Agent Depakote C 500 mg in am Toxicity and 1000 mg at bedtime Depakote C Depakote C Depakote C Lithium C Lithium C IV Lithium C Trazodone C Tegretol C Prilosec C Nystaten C Prozac C Prozac C Klonapin C Klonapin C Xenical C 3 months Xenical C 2 weeks Wellbutrin Sr C Wellbutrin Sr C 2 weeks 22-Feb-2006 08:20 AM Page: 2382 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ambein C Trileptal C Trileptal C 2 weeks Date:12/23/04ISR Number: 4536733-6Report Type:Periodic Company Report #US-JNJFOC-20040807522 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Hepatic Neoplasm Risperdal PS OROPHARINGEAL 2096 DAY Malignant Cogentin C Effexor C Benadryl C Opiate Pain Medication C Bc Powder C Bc Powder C Bc Powder C Lotril C Lotril C Date:12/23/04ISR Number: 4536734-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041002834 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumatosis Intestinalis Risperdal PS OROPHARINGEAL Initial or Prolonged Risperdal SS OROPHARINGEAL Chlorpromazine Hydrochloride SS OROPHARINGEAL Levomepromazine Maleate SS OROPHARINGEAL Clostridium Butyricum C Enoprostil C Brotizolam C Mexiletine Hydrochloride C Calcium C Date:12/23/04ISR Number: 4536799-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041202916 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Visual Field Defect Risperdal PS Date:12/23/04ISR Number: 4536800-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040501364 Age: Gender:Female I/FU:I Outcome PT Other Blood Prolactin Increased Constipation Decreased Appetite Delusion Depression Diarrhoea Disturbance In Attention Galactorrhoea Gastric Polyps 22-Feb-2006 08:20 AM Page: 2383 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination Headache Hepatic Lesion Report Source Product Role Manufacturer Route Dose Duration Infertility Risperdal PS OROPHARINGEAL 15 MON Insomnia Malaise Panic Attack Paranoia Pituitary Tumour Benign Visual Disturbance Weight Decreased Date:12/27/04ISR Number: 4538443-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041204999 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperdal Consta PS INTRAMUSCULAR Leponex SS OROPHARINGEAL Ergenyl C OROPHARINGEAL Ximovan C Date:12/27/04ISR Number: 4538444-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040900519 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Immunoglobulin A Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Increased Haloperidol C nocte Other Lymphadenopathy Kwells C as required Sinus Bradycardia Procyclidine C as required White Blood Cell Count Decreased Date:12/27/04ISR Number: 4538445-1Report Type:Expedited (15-DaCompany Report #EMADSS2002002889 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal PS OROPHARINGEAL 7 MON Decreased Betahistine C UNKNOWN Hydroxyzide C UNKNOWN 2 YR Depixol C UNKNOWN Venlafaxine C UNKNOWN Bendrofluazide C UNKNOWN Procyclidine C UNKNOWN 7 YR Date:12/27/04ISR Number: 4538446-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041106096 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cortisol Increased Risperdal PS OROPHARINGEAL Hyperprolactinaemia Risperdal SS OROPHARINGEAL Polycystic Ovaries Carbamazepine C Pyridoxine C Zineryt C Zineryt C Dermovate C Lorazepam C 1 -2 mg BID PRN 22-Feb-2006 08:20 AM Page: 2384 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benefiber C 5 scoops a day Date:12/27/04ISR Number: 4538447-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040902336 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Drug Abuser Risperdal Consta SS INTRAMUSCULAR Hallucination Methamphetamine SS Paranoia Risperdal Consta SS INTRAMUSCULAR Concerta C UNKNOWN Date:12/27/04ISR Number: 4538448-7Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20041104816 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Risperdal PS OROPHARINGEAL Supraventricular Tachycardia Date:12/27/04ISR Number: 4538449-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041003514 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Risperdal Consta PS INTRAMUSCULAR Myocardial Infarction Risperdal Consta SS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Depakote Er C Klonopin C Abilify C Trazodone C Date:12/27/04ISR Number: 4542007-XReport Type:Expedited (15-DaCompany Report #MK200412-0318-1 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Foreign Anafranil Capsules Syndrome (Strength Unk) PS DAILY Risperdal (Strength Unk) SS Date:12/28/04ISR Number: 4539703-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041105799 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dyskinesia Risperdal PS OROPHARINGEAL Other Dysphagia Risperdal SS OROPHARINGEAL Dysphonia Anafranil C Eructation Lexomil C Oesophageal Pain 22-Feb-2006 08:20 AM Page: 2385 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/04ISR Number: 4539704-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040806976 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dementia Alzheimer'S Type Risperdal PS OROPHARINGEAL 2 YR Risperdal SS OROPHARINGEAL 2 YR Reminyl SS OROPHARINGEAL Antihypertensive C UNKNOWN Date:12/28/04ISR Number: 4539705-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041202916 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Risperdal PS OROPHARINGEAL Increased Risperdal SS OROPHARINGEAL Aspartate Remergil C OROPHARINGEAL Aminotransferase Remergil C OROPHARINGEAL Increased Cipramil C OROPHARINGEAL Blindness Cipramil C OROPHARINGEAL Dose: 20-40 Visual Field Defect mg Date:12/28/04ISR Number: 4539706-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041101676 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Skin Discolouration Risperdal Consta PS INTRAMUSCULAR Viagra C UNKNOWN Date:12/28/04ISR Number: 4540343-4Report Type:Direct Company Report #CTU 235188 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Risperdal 2 Mg Po PS ORAL 2 MG BID PO Extrapyramidal Disorder Date:12/29/04ISR Number: 4540818-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041205328 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Freezing Phenomenon Risperdal PS OROPHARINGEAL Initial or Prolonged Injection Site Pain Risperdal SS OROPHARINGEAL Polydipsia Risperdal Consta SS INTRAMUSCULAR Schizophrenia Plavix C Treatment Noncompliance Welbutrin C Protonix C Tegretol C Date:12/29/04ISR Number: 4540819-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20041205690 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Risperdal PS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2386 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/04ISR Number: 4540820-6Report Type:Periodic Company Report #US-JNJFOC-20040902263 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Patient was taking .5 mg tablet(s), but dosage was unknown. Date:12/29/04ISR Number: 4540822-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040606650 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal PS OROPHARINGEAL 14 DAY Leukopenia Nitrazepam C OROPHARINGEAL Platelet Aggregation Diazepam C OROPHARINGEAL Thrombocytopenia Diazepam C OROPHARINGEAL Sulpride C OROPHARINGEAL Sulpride C OROPHARINGEAL Perospirone C Olanzapine C Date:12/29/04ISR Number: 4540827-9Report Type:Expedited (15-DaCompany Report #FR-MERCK-0412FRA00079 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Hyperosmolar Hyzaar PS Merck & Co., Inc ORAL Hospitalization - Coma Celiprolol Initial or Prolonged Hydrochloride SS ORAL Risperidone SS ORAL Risperidone SS ORAL Trimeprazine Tartrate SS ORAL Date:12/29/04ISR Number: 4540960-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041206026 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal Consta PS INTRAMUSCULAR Date:12/30/04ISR Number: 4542116-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041206047 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dialysis Risperdal PS Hypoxia Overdose Respiratory Depression Date:12/30/04ISR Number: 4542117-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041206163 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged 22-Feb-2006 08:20 AM Page: 2387 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4542118-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041105779 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Potassium Increased Risperdal PS UNKNOWN Sodium Picosulfate C Magnesium Oxide C Date:12/30/04ISR Number: 4542120-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040701114 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal PS OROPHARINGEAL Phosphokinase Increased Flunitrazepam C OROPHARINGEAL Excitability Teprenone C OROPHARINGEAL Haemoglobin Decreased Lorazepam C OROPHARINGEAL Lansoprazole C OROPHARINGEAL Lithium Carbonate C OROPHARINGEAL Levomepromazine Maleate C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL Fk C OROPHARINGEAL Date:12/30/04ISR Number: 4542121-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040901777 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Risperdal PS OROPHARINGEAL Death Dialysis Hallucination Pulmonary Congestion Date:12/30/04ISR Number: 4542122-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040902881 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Risperdal PS OROPHARINGEAL Cardiac Arrest Iron Supplement C Coumadin C Coumadin C Lasix C Ativan C Nexium C Aricept C Lexapro C 1/2 of a 20 mg dose. Tylenol C 22-Feb-2006 08:20 AM Page: 2388 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/30/04ISR Number: 4543316-0Report Type:Direct Company Report #CTU 235419 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Rispeidone 3 Mg PS ORAL 3 MG AMHS ORAL Date:01/03/05ISR Number: 4543158-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041205633 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Risperdal Consta PS INTRAMUSCULAR Drug Exposure During Pregnancy Date:01/03/05ISR Number: 4543159-8Report Type:Expedited (15-DaCompany Report #GR-JNJFOC-20041205714 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Subarachnoid Haemorrhage Risperdal Consta PS INTRAMUSCULAR Akineton C OROPHARINGEAL Date:01/03/05ISR Number: 4543160-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041205810 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Risperdal PS Initial or Prolonged Pregnancy Other Jaundice Neonatal Date:01/03/05ISR Number: 4543161-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041206419 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Megaloblastic Risperdal PS Olanzapine C Date:01/03/05ISR Number: 4543162-8Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20041204493 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Fractures Risperdal Consta PS INTRAMUSCULAR Date:01/03/05ISR Number: 4543538-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040701116 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Risperdal PS OROPHARINGEAL Sennoside C OROPHARINGEAL Flunitrazepam C OROPHARINGEAL Sodium Valproate C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2389 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/05ISR Number: 4543587-0Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0346594A Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delirium Paxil PS Glaxosmithkline ORAL 107 DAY Drooling Risperdal SS ORAL 1MG Three Personality Change times per day 79 DAY Speech Disorder Rohypnol C UNKNOWN Zyprexa C ORAL Benzalin C ORAL Triptanol C UNKNOWN Haloperidol C UNKNOWN Chlorpromazine Hydrochloride C Glaxosmithkline UNKNOWN Date:01/03/05ISR Number: 4543605-XReport Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0360618A Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Agitation Paxil PS Glaxosmithkline ORAL 32 WK Akinesia Risperidone SS ORAL 2MG Per day 2 DAY Anxiety Artane C ORAL 2MG Three Blood Creatine times per day 14 WK Phosphokinase Increased Solanax C ORAL .4MG Three Mutism times per day 21 WK Myoclonus Silece C UNKNOWN 2MG Per day 22 WK Pain Laxoberon C ORAL 2.5MG Per day 21 WK Rhabdomyolysis Pursennid C ORAL 12MG Per day 21 WK Serotonin Syndrome Stupor Date:01/03/05ISR Number: 4543745-5Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-04P-167-0275258-00 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Epilim Tablets PS Initial or Prolonged Drug Interaction Epilim Tablets SS Other Drug Level Increased Epilim Tablets SS Hyponatraemia Levetiracetam C Pancytopenia Procyclidine C Dipixol C INTRAMUSCULAR Olanzapine C Dipixol C INTRAMUSCULAR Temazepam C Citalopram C Risperidone I Risperidone I Date:01/03/05ISR Number: 4545333-3Report Type:Expedited (15-DaCompany Report #2004243359JP Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Foreign Cabaser Syndrome Health (Carbergoline) PS ORAL 0.5 MG (0.5 Professional MG), ORAL Risperidone (Risperidone) SS ORAL ORAL Zotepine (Zotepine) SS ORAL ORAL Levomepromazine 22-Feb-2006 08:20 AM Page: 2390 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maleate (Levomepromazine Maleate) SS ORAL 50 MG ( 50 MG), ORAL Pergolide Mesilate (Pergolide Mesilate) SS ORAL (500 MCG), ORAL Valproate Sodium (Valporate Sodium) C Lithium Carbonate (Lithium Carbonate) C Date:01/04/05ISR Number: 4543812-6Report Type:Expedited (15-DaCompany Report #JP-SOLVAY-00304004218 Age:25046 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Luvox 25 PS ORAL Daily dose: Initial or Prolonged Anaemia 75 Anorexia milligram(s) 830 DAY Aspartate Pl Granule C ORAL Daily dose: 3 Aminotransferase gram(s) 4 DAY Increased Cefzone C ORAL Daily dose: Basophil Count Abnormal 300 Blood Alkaline milligram(s) 4 DAY Phosphatase Decreased Paxil I ORAL Daily dose: Blood Creatine 10 Phosphokinase Increased milligram(s) 39 DAY Blood Lactate Paxil I ORAL Daily dose: Dehydrogenase Increased 20 Convulsion milligram(s) 20 DAY Dehydration Risperidone I ORAL Daily dose: 3 Dizziness milligram(s) 2 YR Drug Interaction Paxil I ORAL Daily dose: Eosinophil Count Abnormal 40 Fatigue milligram(s) 523 DAY Haematocrit Decreased Paxil I ORAL Daily dose: Haemoglobin Decreased 20 Laboratory Test Abnormal milligram(s) 308 DAY Lymphocyte Count Abnormal Paxil I ORAL Daily dose: Medication Error 10 Nasopharyngitis milligram(s) 17 DAY Neutrophil Count Abnormal Pyrexia Red Blood Cell Count Decreased Red Cell Distribution Width Abnormal Serotonin Syndrome Somnolence Treatment Noncompliance Tremor White Blood Cell Count Abnormal Date:01/04/05ISR Number: 4543941-7Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20041206401 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2391 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/04/05ISR Number: 4543942-9Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20041205613 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Ankle Fracture Risperdal Consta SS INTRAMUSCULAR Fall Risperdal SS OROPHARINGEAL Injury Risperdal SS OROPHARINGEAL Suicidal Ideation Risperdal Consta SS INTRAMUSCULAR Diazepam C Salbutamol C Date:01/04/05ISR Number: 4543943-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041105779 Age:93 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Potassium Increased Risperdal PS UNKNOWN Sodium Picosulfate C Magnesium Oxide C Date:01/04/05ISR Number: 4544059-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041201748 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Risperdal PS OROPHARINGEAL Dose: 0.4 ml Dyskinesia mane and 0.6 ml nocte Risperdal SS OROPHARINGEAL taken at night Risperdal SS OROPHARINGEAL 0.5 mg mane and 1.0 mg nocte Risperdal SS OROPHARINGEAL taken at night Risperdal SS OROPHARINGEAL Strattera C Date:01/04/05ISR Number: 4544060-6Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20041206691 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Myasthenic Syndrome Risperdal PS Date:01/05/05ISR Number: 4545271-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20030805071 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Risperdal PS OROPHARINGEAL Hospitalization - Circulatory Collapse Clozapine SS OROPHARINGEAL Initial or Prolonged Dyspnoea Disability Intracardiac Thrombus Other Myocardial Infarction Ventricular Fibrillation 22-Feb-2006 08:20 AM Page: 2392 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/05/05ISR Number: 4545297-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050100034 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aneurysm Risperdal PS OROPHARINGEAL Date:01/06/05ISR Number: 4546125-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050100619 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Risperdal PS Initial or Prolonged Lipitor SS OROPHARINGEAL Date:01/06/05ISR Number: 4546126-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040901175 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Vasculitis Risperdal PS OROPHARINGEAL 0.5 mg - 1 mg Retinitis Pigmentosa Date:01/06/05ISR Number: 4546127-5Report Type:Periodic Company Report #US-JNJFOC-20040904088 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS UNKNOWN Date:01/06/05ISR Number: 4546239-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040305774 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Overdose Risperdal PS OROPHARINGEAL Initial or Prolonged Overdose Aripiprazole SS OROPHARINGEAL Paranoia Acetaminophen SS Psychotic Disorder Pseudoephedrine C Suicide Attempt Suspiciousness Urinary Incontinence Vomiting Date:01/06/05ISR Number: 4548336-8Report Type:Direct Company Report #CTU 235832 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Balance Disorder Risperdal 1 Mg 2 A Hospitalization - Fall Day Janerson With J Initial or Prolonged And J Co PS Janerson With J And Required J Co Intervention to Prevent Permanent Impairment/Damage 22-Feb-2006 08:20 AM Page: 2393 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/05ISR Number: 4547135-0Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20041207584 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Risperdal PS OROPHARINGEAL Initial or Prolonged Depakin Chrono SS OROPHARINGEAL Seroquel SS OROPHARINGEAL Phenobarbital C OROPHARINGEAL Date:01/07/05ISR Number: 4547136-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041102038 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Risperdal PS OROPHARINGEAL Refusal Of Treatment By Patient Treatment Noncompliance Visual Disturbance Date:01/07/05ISR Number: 4547137-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041106096 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cortisol Increased Risperdal PS OROPHARINGEAL Hyperprolactinaemia Risperdal SS OROPHARINGEAL Polycystic Ovaries Carbamazepine C Pyridoxine C Zineryt C Zineryt C Dermovate C Lorazepam C 1 -2 mg BID PRN Benefiber C 5 scoops a day Date:01/07/05ISR Number: 4547216-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050100373 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Risperdal PS UNKNOWN Initial or Prolonged Herpes Zoster Risperdal SS UNKNOWN Placebo SS Placebo SS Bifeprunox C UNKNOWN Bifeprunox C UNKNOWN Date:01/07/05ISR Number: 4548639-7Report Type:Direct Company Report #CTU 235870 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Risperdal PS 2 MG TABS Risperdal SS 0.5 MG TABS 22-Feb-2006 08:20 AM Page: 2394 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/05ISR Number: 4551544-3Report Type:Expedited (15-DaCompany Report #2004-12-0852 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Foreign Peg-Intron Hospitalization - Delusional Disorder, Health (Peginterferon Initial or Prolonged Persecutory Type Professional Alfa-2b) Injectable PS SUBCUTANEOUS 80 MCG Other Extrapyramidal Disorder Company SUBCUTANEOUS Fibrin D Dimer Increased Representative Rebetol (Ribavirin) Sudden Death Capsules SS ORAL WEIGHT-BASED Thrombophlebitis ORAL Superficial Risperidone SS Date:01/10/05ISR Number: 4548141-2Report Type:Periodic Company Report #AU-JNJFOC-20041205613 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Risperdal Consta PS INTRAMUSCULAR Hospitalization - Ankle Fracture Risperdal Consta SS INTRAMUSCULAR Initial or Prolonged Chronic Obstructive Risperdal SS OROPHARINGEAL Pulmonary Disease Risperdal SS OROPHARINGEAL Injury Risperdal Consta SS INTRAMUSCULAR Suicidal Ideation Diazepam C Salbutamol C Ventolin C 20 mg Date:01/10/05ISR Number: 4548399-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050100651 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Insipidus Risperdal PS OROPHARINGEAL Initial or Prolonged Hospitalisation Depakote C OROPHARINGEAL Seroquel C OROPHARINGEAL Date:01/10/05ISR Number: 4550052-3Report Type:Expedited (15-DaCompany Report #2002055047 Age: Gender:Male I/FU:F Outcome PT Other Agitation Balance Disorder Delusion Dermatitis Contact Diplopia Dizziness Drug Dependence Dyspnoea Ear Congestion Fall General Physical Health Deterioration Hallucination Heart Rate Increased Hepatic Enzyme Increased Hepatic Steatosis Hepatomegaly Hyperhidrosis Liver Disorder Malaise Muscle Twitching 22-Feb-2006 08:20 AM Page: 2395 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Musculoskeletal Stiffness Nasal Congestion Nasal Polyps Report Source Product Role Manufacturer Route Dose Duration Photosensitivity Reaction Consumer Navane (Capsules) Restlessness Health (Thiothixene) PS ORAL 4 MG (DAILY), Scar Professional ORAL Sinus Congestion Risperdal Sinusitis (Risperidone) SS UNKNOWN 1 MG (DAILY), Somnolence UNKNOWN Stomach Discomfort All Other Tinnitus Non-Therapeutic Tremor Products (All Other Vision Blurred Non-Therapeutic Visual Disturbance Products) SS UNKNOWN UNK Diphenhydramine (Diphenhydramine) C Lansoprazole (Lansoprazole) C Hydroxyzine Embonate (Hydroxyzine Embonate) C Date:01/10/05ISR Number: 4551529-7Report Type:Direct Company Report #CTU 236023 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Discharge Risperidone PS Galactorrhoea Olanazpine SS Date:01/12/05ISR Number: 4550658-1Report Type:Expedited (15-DaCompany Report #IT-ABBOTT-05P-083-0285874-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bicytopenia Depakine Chrono Initial or Prolonged Tablets PS ORAL 30 DAY Quetiapine SS ORAL 31 DAY Risperidone SS ORAL 2 DAY Phenobarbital Sodium C ORAL 1 DAY Date:01/13/05ISR Number: 4551792-2Report Type:Expedited (15-DaCompany Report #2005000542 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ill-Defined Disorder Quilonum Retard PS Glaxosmithkline ORAL 9450MG Single Intentional Overdose dose Overdose Risperdal SS ORAL 17.5MG Single Somnolence dose Suicide Attempt Trileptal SS ORAL 11550MG Single dose Cipralex SS ORAL 350MG Single dose 22-Feb-2006 08:20 AM Page: 2396 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/13/05ISR Number: 4553093-5Report Type:Expedited (15-DaCompany Report #2005006045 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticonvulsant Drug Level Consumer Dilantin Kapseals Initial or Prolonged Above Therapeutic (Phenytoin Sodium) PS ORAL 300 MG (300 Other Aortic Valve Stenosis MG, 1 IN 1 Convulsion D), ORAL Dementia Neurontin Fatigue (Gabapentin) SS ORAL 600 MG (300 Hunger MG, 2 IN 1 Incontinence D), ORAL Loss Of Consciousness Phenytoin Medication Error (Phenytoin) SS Multiple Drug Overdose Risperidone Accidental (Risperidone) SS ORAL 1 MG (0.5 MG, Pharmaceutical Product 2 IN 1 D), Complaint ORAL Prostatic Disorder Furosemide Treatment Noncompliance (Furosemide) C Date:01/14/05ISR Number: 4553021-2Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-12759262 Age:53 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Abilify PS Otsuka Initial or Prolonged Confusional State Pharmaceutical Depressed Mood Company, Ltd. ORAL Increased to Disorientation 15 mg/day on Disturbance In Attention 02-Oct-2004. Drug Interaction Discontinued Middle Insomnia on 60 DAY Restlessness Eunerpan SS ORAL Social Avoidant Behaviour Enahexal C ORAL Thinking Abnormal Hctz C ORAL Risperdal I ORAL 3 mg/day from 13-Aug-04 to 01-Oct-04; 5 mg/day since 02-Oct-04. Date:01/14/05ISR Number: 4553125-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050100914 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Risperdal PS OROPHARINGEAL Initial or Prolonged Disturbance In Attention Risperdal SS OROPHARINGEAL Drug Interaction Enahexal C OROPHARINGEAL Mental Disorder Hct Hexal C OROPHARINGEAL Restlessness Abilify I OROPHARINGEAL Sleep Disorder Abilify I OROPHARINGEAL Eunerpan I OROPHARINGEAL Date:01/14/05ISR Number: 4553126-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041204999 Age: Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 2397 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Thrombocytopenia Risperdal Consta PS INTRAMUSCULAR Leponex SS OROPHARINGEAL Ergenyl Chrono SS OROPHARINGEAL Ergenyl Chrono SS OROPHARINGEAL Ximovan C Date:01/14/05ISR Number: 4553127-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050101647 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS Date:01/14/05ISR Number: 4553128-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041202830 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Risperidone C OROPHARINGEAL 1 mg in Other morning, 3 mg at night Date:01/14/05ISR Number: 4553129-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20041007451 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Idiopathic Risperdal PS OROPHARINGEAL Thrombocytopenic Purpura Risperdal SS OROPHARINGEAL Splenomegaly Truxal C OROPHARINGEAL 200-100-200 mg Date:01/14/05ISR Number: 4553131-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041200355 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alveolitis Allergic Risperdal PS OROPHARINGEAL Hospitalization - Leukopenia Alvityl C Initial or Prolonged Neutropenia Other Date:01/14/05ISR Number: 4553132-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041206026 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal Consta PS INTRAMUSCULAR Risperdal SS OROPHARINGEAL Date:01/14/05ISR Number: 4553133-3Report Type:Periodic Company Report #US-JNJFOC-20040703693 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2398 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/05ISR Number: 4553134-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040702328 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Risperdal PS OROPHARINGEAL Alanine Aminotransferase Risperdal SS OROPHARINGEAL Increased Risperdal SS OROPHARINGEAL Condition Aggravated Risperdal SS OROPHARINGEAL Constipation Risperdal SS OROPHARINGEAL Leukopenia Risperdal SS OROPHARINGEAL Muscle Rigidity Risperdal SS OROPHARINGEAL Psychiatric Symptom Risperdal SS OROPHARINGEAL Thirst Risperdal SS OROPHARINGEAL Tremor Risperdal SS OROPHARINGEAL Weight Increased Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Flunitrazepam C OROPHARINGEAL Flunitrazepam C OROPHARINGEAL Flunitrazepam C OROPHARINGEAL Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Etizolam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Olanzapine C OROPHARINGEAL 51 DAY Olanzapine C OROPHARINGEAL 51 DAY Quazepam C OROPHARINGEAL 56 DAY Quazepam C OROPHARINGEAL 56 DAY Quazepam C OROPHARINGEAL 56 DAY Quazepam C OROPHARINGEAL 56 DAY Sennoside C Sennoside C Sennoside C Sennoside C Brotizolam C Brotizolam C Magnesium Oxide C Magnesium Oxide C Magnesium Oxide C Magnesium Oxide C Magnesium Oxide C Magnesium Oxide C Magnesium Oxide C 22-Feb-2006 08:20 AM Page: 2399 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/14/05ISR Number: 4556147-2Report Type:Expedited (15-DaCompany Report #2005002789 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastric Cancer Foreign Lipitor Hypothyroidism Health (Atorvastatin) PS ORAL 5 MG (1 IN 1 Platelet Count Decreased Professional D), ORAL Levomepromazine Maleate (Levomepromazine Maleate) SS ORAL 50 MG (1 IN 1 D), ORAL Zotepine (Zotepine) SS ORAL 150 MG (1 IN 1 D), ORAL Risperidone (Risperidone) SS ORAL 3 MG (1 IN 1 D), ORAL Drug, Unspecified (Drug, Unspecified) SS ORAL ORAL Date:01/14/05ISR Number: 4556422-1Report Type:Expedited (15-DaCompany Report #2004SE07287 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Seroquel PS ORAL 1 G DAILY PO Initial or Prolonged Health Depakin Chrono SS ORAL 1 G DAILY PO Professional Risperdal SS ORAL 3 MG DAILY PO Other Gardenale C Date:01/14/05ISR Number: 4556717-1Report Type:Expedited (15-DaCompany Report #2004100399 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Disorder Consumer Neurontin Initial or Prolonged Nerve Injury (Gabapentin) PS Other Pancreatitis Risperidone Sexual Dysfunction (Risperidone) SS ORAL ORAL Weight Increased All Other Therapeutic Products (All Other Therapeutic Products) C Date:01/14/05ISR Number: 4556986-8Report Type:Expedited (15-DaCompany Report #2004UW24380 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Health Seroquel PS ORAL 200 MG HS PO Bronchitis Professional Risperdal SS ORAL 1 MG QAM PO Circulatory Collapse Risperdal SS 0.5 MG QAM Dizziness Carbatrol SS ORAL 300 MG Q12H Fatigue PO Feeling Abnormal Zithromax C Loss Of Consciousness Ortho Tri-Cyclen C Pain In Extremity Flonase C Pulmonary Embolism Maxalt-Mlt C Motrin C Lidocaine Jelly C Albuterol C 22-Feb-2006 08:20 AM Page: 2400 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pepcid C Cleocin T C Flexeril C Icy Hot C Depo-Provera C Date:01/18/05ISR Number: 4553932-8Report Type:Expedited (15-DaCompany Report #JP-ABBOTT-05P-087-0285506-00 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ammonia Increased Depakene PS ORAL 15 DAY Life-Threatening Ascites Bicamol SS ORAL 15 DAY Hospitalization - Blood Pressure Decreased Vegetamin SS ORAL 78 DAY Initial or Prolonged Bradycardia Risperidone SS ORAL 15 DAY Other Coma Carbamazepine SS ORAL 15 DAY Condition Aggravated Diazepam SS ORAL 60 DAY Dysphagia Sulpiride SS ORAL 50 DAY Hepatic Function Abnormal Quetiapine SS ORAL 1 DAY Hepatitis Acute Chlorpromazine C ORAL 53 DAY Hypercapnia Flunitrazepam C ORAL 78 DAY Hypoxia Bromperidol C ORAL 53 DAY Jaundice Promethazine Logorrhoea Hydrochloride C ORAL 53 DAY Multi-Organ Failure Neuroleptic Malignant Syndrome Oliguria Pneumonia Pyrexia Renal Impairment Soliloquy Sputum Retention Stupor Unevaluable Event Unresponsive To Verbal Stimuli Date:01/18/05ISR Number: 4554505-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050101613 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS Epilepsy Sultopride Hydrochloride C Carbamazepine C Bromazepam C Phenytoin C Nitrazepam C Date:01/18/05ISR Number: 4554506-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050101615 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Risperdal PS UNKNOWN Complete Sinus Arrhythmia 22-Feb-2006 08:20 AM Page: 2401 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/18/05ISR Number: 4554507-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041200186 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Risperdal PS OROPHARINGEAL Dyspnoea Risperdal SS OROPHARINGEAL Pain In Extremity Ortho Tri-Cyclen SS Pulmonary Embolism Seroquel C OROPHARINGEAL Vaginal Infection Carbatrol C OROPHARINGEAL Zithromax C OROPHARINGEAL Depo-Provera C INTRAMUSCULAR Date:01/18/05ISR Number: 4554508-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041006497 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Risperdal PS OROPHARINGEAL Infarction Risperdal SS OROPHARINGEAL Angina Pectoris Risperdal SS OROPHARINGEAL Extrapyramidal Disorder Risperdal SS OROPHARINGEAL Nitroglycerin C Diazepam C Diazepam C Biperiden Hydrochloride C Date:01/18/05ISR Number: 4554509-0Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040910153 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS OROPHARINGEAL White Blood Cell Count Decreased Date:01/18/05ISR Number: 4554510-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040906841 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anal Fissure Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Anal Haemorrhage Risperdal Consta SS INTRAMUSCULAR Constipation Date:01/18/05ISR Number: 4554511-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041207553 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Total daily Pyrexia dose = 3-4 mg/day. Date:01/18/05ISR Number: 4554512-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040606650 Age:75 YR Gender:Female I/FU:I Outcome PT Other Anaemia Idiosyncratic Drug Reaction 22-Feb-2006 08:20 AM Page: 2402 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Leukopenia Platelet Aggregation Thrombocytopenia Report Source Product Role Manufacturer Route Dose Duration Risperdal PS OROPHARINGEAL 14 DAY Nitrazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Sulpride C OROPHARINGEAL Sulpride C OROPHARINGEAL Perospirone C Olanzapine C Date:01/18/05ISR Number: 4554513-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041001503 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Pancreatic Risperdal PS OROPHARINGEAL Neoplasm Date:01/18/05ISR Number: 4554742-8Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0519822A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Paxil PS Glaxosmithkline ORAL 30MG Per day Initial or Prolonged Dizziness Wellbutrin SS Glaxosmithkline Drug Withdrawal Syndrome Flexeril SS Feeling Abnormal Skelaxin SS Intentional Overdose Antiinflammatory SS Multiple Drug Overdose Aspirin SS Glaxosmithkline Intentional Theophylline SS Suicidal Ideation Risperdal SS Suicide Attempt Cold Medicine SS Date:01/18/05ISR Number: 4554783-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041101099 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Risperdal PS OROPHARINGEAL 6 YR Initial or Prolonged Diabetes Mellitus Risperdal SS OROPHARINGEAL 6 YR Other Non-Insulin-Dependent Benadryl C OROPHARINGEAL Drug Exposure During Lorazepam C OROPHARINGEAL Pregnancy Diovan C OROPHARINGEAL Date:01/18/05ISR Number: 4556687-6Report Type:Expedited (15-DaCompany Report #SUS1-2004-00783 Age:19 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Health Carbatrol Dizziness Professional (Carbamazepine) Loss Of Consciousness Capsule Xr PS ORAL 300 MG, EVERY Pain In Extremity 12 HOURS,ORAL Pulmonary Embolism Seroquel (Quetiapine Fumarate) SS ORAL 200 MG, EVERY HS, ORAL Risperdal(Risperidon e) SS 1 MG, 1X/DAY:QD IN 22-Feb-2006 08:20 AM Page: 2403 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report AM Date:01/18/05ISR Number: 4557294-1Report Type:Expedited (15-DaCompany Report #2005003481 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Foreign Lithium (Lithium) PS Initial or Prolonged Confusional State Literature Topiramate Disturbance In Attention Health (Topiramate) SS Lethargy Professional Risperidone Mania (Risperidone) SS Clonazepam (Clonazepam) SS Lamotrigine (Lamotrigine) SS Valproic Acid (Valproic Acid) C Date:01/19/05ISR Number: 4555778-3Report Type:Expedited (15-DaCompany Report #PHRM2005FR00522 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Tareg PS Novartis Sector: Initial or Prolonged Cogwheel Rigidity Pharma ORAL 1 DF, QD Disorientation Endotelon SS ORAL 2 DF/day Dyskinesia Risperdal SS ORAL 1 mg/day Fall Temesta SS ORAL 1 mg/day Gait Disturbance Solian SS ORAL 1 DF, QD Posture Abnormal Plavix SS ORAL 1 DF, QD Date:01/19/05ISR Number: 4557228-XReport Type:Direct Company Report #CTU 237183 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Risperdal PS ORAL 2-3 MG @ Initial or Prolonged Dyspnoea BEDTIME Electrocardiogram ORAL Abnormal Malaise Vomiting Date:01/19/05ISR Number: 4557358-2Report Type:Direct Company Report #CTU 237202 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nausea Valproic Acid PS ORAL 500MG TID Initial or Prolonged Vomiting ORAL Risperdal SS ORAL 2MG BID ORAL Date:01/19/05ISR Number: 4559428-1Report Type:Expedited (15-DaCompany Report #2004-12-0852 Age:32 YR Gender:Female I/FU:F Outcome Death Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 2404 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Report Source Product Role Manufacturer Route Dose Duration Cardio-Respiratory Arrest Foreign Peg-Intron Delusional Disorder, Health (Peginterferon Persecutory Type Professional Alfa-2b) Injectable PS SUBCUTANEOUS 80 MCG Drug Intolerance Company SUBCUTANEOUS Extrapyramidal Disorder Representative Rebetol (Ribavirin) Sudden Death Capsules SS ORAL WEIGH-BASED Thrombophlebitis ORAL Risperidone SS Date:01/20/05ISR Number: 4556700-6Report Type:Expedited (15-DaCompany Report #200510142FR Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Daonil PS Aventis Initial or Prolonged Extrapyramidal Disorder Pharmaceuticals Inc. ORAL Nootropyl SS ORAL Mopral SS ORAL Durogesic SS TRANSDERMAL Celebrex SS ORAL Deroxat SS ORAL Risperdal SS ORAL Stagid C ORAL Glucor C ORAL Chronadalate C ORAL Discotrine C TRANSDERMAL Xanax C ORAL Fozitec C ORAL Date:01/20/05ISR Number: 4556750-XReport Type:Expedited (15-DaCompany Report #200510142FR Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Daonil PS Aventis Initial or Prolonged Extrapyramidal Disorder Pharmaceuticals Inc. ORAL Nootropyl SS ORAL Mopral SS ORAL Durogesic SS TRANSDERMAL Celebrex SS ORAL Deroxat SS ORAL Risperdal SS ORAL Stagid C ORAL Glucor C ORAL Chronadalate C ORAL Discotrine C TRANSDERMAL Xanax C ORAL Fozitec C ORAL Date:01/20/05ISR Number: 4557028-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050102782 Age:19 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Risperdal PS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2405 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/20/05ISR Number: 4557029-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041202830 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Risperidone C OROPHARINGEAL 1 mg in Other morning, 3 mg at night Date:01/20/05ISR Number: 4559170-7Report Type:Direct Company Report #CTU 237438 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Autonomic Nervous System Memantine Po PS ORAL 5 MG PO TID Imbalance Risperdal SS ORAL 1 MG PO QHS Fall Humerus Fracture Date:01/20/05ISR Number: 4560001-XReport Type:Direct Company Report #CTU 237424 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Lethargy Resperidone 1.0mg Intervention to Q8h Jansen PS Jansen ORAL 1.0MG Q8H Prevent Permanent PO Impairment/Damage Date:01/21/05ISR Number: 4558636-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050102302 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Risperdal PS OROPHARINGEAL Diarrhoea Tercian C Hypotension Nausea Pyrexia Vomiting Date:01/21/05ISR Number: 4558637-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050102306 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neutropenia Risperdal PS OROPHARINGEAL Initial or Prolonged Depamide SS OROPHARINGEAL Lepticur C Tercian C Date:01/21/05ISR Number: 4558638-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050102560 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Durogesic PS TRANSDERMAL Initial or Prolonged Personality Change Risperdal SS OROPHARINGEAL Nootropyl SS OROPHARINGEAL Mopral SS OROPHARINGEAL Daonil SS OROPHARINGEAL Deroxat SS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2406 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Celebrex SS OROPHARINGEAL Discotrine C UNKNOWN Xanax C UNKNOWN Fozitec C UNKNOWN Stagid C UNKNOWN Glucor C UNKNOWN Chronadalate C UNKNOWN Date:01/21/05ISR Number: 4558639-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050103391 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pericardial Effusion Risperdal PS nocte Benzafibrate C Lithium C Paroxetine C Metformin C Glicazide C Ranitidine C Enalapril C Amlodopine C Date:01/21/05ISR Number: 4558640-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050103909 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Risperdal PS UNKNOWN Initial or Prolonged Aspartate Luvox SS UNKNOWN Aminotransferase Paxil SS UNKNOWN Increased Paxil SS UNKNOWN Blood Alkaline Phosphatase Decreased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Convulsion Dehydration Haematocrit Decreased Haemoglobin Decreased Nasopharyngitis Red Blood Cell Count Decreased Serotonin Syndrome Tremor Date:01/21/05ISR Number: 4558641-7Report Type:Periodic Company Report #DE-JNJFOC-20041104072 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Risperdal Consta PS INTRAMUSCULAR 22-Feb-2006 08:20 AM Page: 2407 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4558642-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040500945 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Risperidone PS UNKNOWN 308 DAY Initial or Prolonged Gastrointestinal Necrosis Olanzapine SS UNKNOWN 308 DAY Pneumonia Quetiapine SS UNKNOWN 308 DAY Trazodone C Mvi C Mvi C Mvi C Mvi C Mvi C Mvi C Mvi C Mvi C Feso4 C Carbamazepine C OROPHARINGEAL Date:01/21/05ISR Number: 4558643-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040602002 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Amylase Increased Risperdal PS OROPHARINGEAL Diabetes Mellitus Risperdal SS OROPHARINGEAL Hepatic Function Abnormal Antibiotics Nos SS Hypercholesterolaemia Mosapride Citrate C OROPHARINGEAL Iron Deficiency Anaemia Itopride Nasopharyngitis Hydrochloride C OROPHARINGEAL Rilmazafone Hydrochloride C OROPHARINGEAL Ecabet Sodium C OROPHARINGEAL Teprenone C OROPHARINGEAL Sodium Alginate C OROPHARINGEAL Lansoprazole C OROPHARINGEAL Promethazine Hydrochloride C OROPHARINGEAL Amezinium Metilsulfate C OROPHARINGEAL Amezinium Metilsulfate C OROPHARINGEAL Magnesium Oxide C OROPHARINGEAL Flavoxate Hydrochloride C OROPHARINGEAL Flavoxate Hydrochloride C OROPHARINGEAL Antibiotics C UNKNOWN Ferrous Sulfate C Date:01/21/05ISR Number: 4558644-2Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20040902726 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Risperdal Consta PS INTRAMUSCULAR Overdose Clonazepam C OROPHARINGEAL Zoplicone C OROPHARINGEAL Benztropine C OROPHARINGEAL Citalopram C 22-Feb-2006 08:20 AM Page: 2408 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4558646-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041202830 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Risperidone C OROPHARINGEAL Disability Risperidone C OROPHARINGEAL Other Date:01/21/05ISR Number: 4558799-XReport Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0363970A Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Deroxat PS Glaxosmithkline ORAL Initial or Prolonged Extrapyramidal Disorder Nootropyl SS ORAL Mopral SS Glaxosmithkline Durogesic SS TOPICAL Celebrex SS ORAL Daonil SS ORAL Risperdal SS Skenan C Glaxosmithkline Stagid C Glucor C Insulin C Chronadalate C Glaxosmithkline Discotrine C Glaxosmithkline Xanax C Fozitec C Date:01/21/05ISR Number: 4559255-5Report Type:Direct Company Report #CTU 237632 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Risperdal M Tab Diarrhoea 2mg Janssen PS Janssen ORAL 2MG BID Heart Rate Increased ORAL Pyrexia Risperdal M Tab Thrombotic 1mg Janssen SS Janssen ORAL 1MG BID Thrombocytopenic Purpura ORAL Seroquel C Depakote Syrup C Cogentin C Benadryl C Mom C Maalox Max C Nte C Tylenol C Date:01/21/05ISR Number: 4560661-3Report Type:Expedited (15-DaCompany Report #DSA_25398_2004 Age:28 YR Gender:Male I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Arthralgia Aspartate Aminotransferase Increased Blood Creatine 22-Feb-2006 08:20 AM Page: 2409 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphokinase Increased Blood Lactate Dehydrogenase Increased Infection Report Source Product Role Manufacturer Route Dose Duration Myalgia Foreign Tavor PS ORAL 2 MG Q DAY PO White Blood Cell Count Health Risperdal SS ORAL 6 MG Q DAY PO Decreased Professional Risperdal SS ORAL 7 MG Q DAY PO Other Risperidone SS INTRAMUSCULAR 37.5 MG Q2WK IM Noctamid C Akineton /Aus/ C Date:01/21/05ISR Number: 4560724-2Report Type:Expedited (15-DaCompany Report #2004AP05470 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ascites Foreign Seroquel PS ORAL 100 MG TID PO Life-Threatening Blood Pressure Decreased Health Tegretol SS ORAL 100 MG TID PO Hospitalization - Bradycardia Professional Horizon SS ORAL 5 MG QID PO Initial or Prolonged Cardiac Disorder Other Silece SS ORAL 2 MG BID PO Dysphagia Hirnamin SS ORAL 5 MG TID PO Hepatitis Vegetamin A SS Hepatitis Acute Risperdal SS ORAL 2 MG TID PO Hypercapnia Dogmatyl SS ORAL 100 MG TID PO Multi-Organ Failure Depakene-R SS ORAL 200 MG TID PO Neuroleptic Malignant Glycyron C Syndrome Dasen C Pneumonia Aspiration Pneumonia Bacterial Renal Impairment Sepsis Stupor Date:01/21/05ISR Number: 4560727-8Report Type:Expedited (15-DaCompany Report #2004AP06253 Age:50 YR Gender:Female I/FU:F Outcome PT Death Abnormal Behaviour Alanine Aminotransferase Increased Anoxic Encephalopathy Aspartate Aminotransferase Increased Bacteria Urine Identified Blood Lactate Dehydrogenase Increased Blood Pressure Decreased Bradycardia Brain Death Cardio-Respiratory Arrest Delirium Diabetes Insipidus Diverticulitis Inflammation Insomnia Large Intestine Carcinoma Loss Of Consciousness Memory Impairment Pulmonary Artery 22-Feb-2006 08:20 AM Page: 2410 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Thrombosis Renal Infarct Respiratory Rate Decreased Report Source Product Role Manufacturer Route Dose Duration Restlessness Foreign Seroquel PS ORAL 100 MG DAILY Shock Health PO Supraventricular Professional Akineton SS ORAL 1 MG TID PO Extrasystoles Other Hirnamin SS ORAL 50 MG TID PO Ventricular Fibrillation Linton SS ORAL 9 MG TID PO Risperdal SS ORAL 2 MG TID PO Rohypnol SS Vegetamin B SS ORAL 50 MG DAILY PO Pursennid C Date:01/21/05ISR Number: 4561429-4Report Type:Expedited (15-DaCompany Report #2005006045 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anticonvulsant Drug Level Consumer Dilantin Kapseals Initial or Prolonged Increased (Phenytoin Sodium) PS ORAL SEE IMAGE Other Aortic Valve Stenosis Neurontin Condition Aggravated (Gabapentin) SS ORAL 600 MG (300 Convulsion MG, 2 IN 1 Dementia D), ORAL Fatigue Phenytoin Hunger (Phenytoin) SS Incontinence Risperidone Loss Of Consciousness (Risperidone) SS ORAL 1 MG (0.5 MG, Medication Error 2 IN 1 D), Overdose ORAL Pharmaceutical Product Furosemide Complaint (Furosemide) C Prostatic Disorder Date:01/24/05ISR Number: 4559194-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050102024 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Congenital Risperdal PS INTRA-UTERINE Initial or Prolonged Abnormalities Noctamide C INTRA-UTERINE Congenital Anomaly Date:01/24/05ISR Number: 4559195-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050102386 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psoriasis Risperdal PS OROPHARINGEAL Paroxetine C OROPHARINGEAL Buspirone C OROPHARINGEAL Diazepam C Date:01/24/05ISR Number: 4559196-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050103393 Age: Gender:Male I/FU:I Outcome PT Death Gastric Dilatation Intestinal Dilatation 22-Feb-2006 08:20 AM Page: 2411 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Sepsis Report Source Product Role Manufacturer Route Dose Duration Risperdal PS Olanzapine SS Trazadone SS Lipostat C Tenormin C Tritace C Aspirine C Digoxine C Atrovent C Warfarin C Date:01/24/05ISR Number: 4559197-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050103396 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Risperdal Consta PS INTRAMUSCULAR Life-Threatening Myocardial Infarction Risperdal Consta SS INTRAMUSCULAR Diclofenac C OROPHARINGEAL Amoxicilline C OROPHARINGEAL Date:01/24/05ISR Number: 4559198-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041006137 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Delusion Risperdal PS OROPHARINGEAL Other Depression Risperdal SS OROPHARINGEAL Heart Rate Irregular Self-Injurious Ideation Date:01/24/05ISR Number: 4559437-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050103313 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Risperdal PS OROPHARINGEAL Initial or Prolonged Syndrome Rhabdomyolysis Water Intoxication Date:01/24/05ISR Number: 4559438-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041207553 Age:48 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pyrexia Health Risperdal PS OROPHARINGEAL Total daily Sudden Death Professional dose = 3-4 mg/day. Litium SS OROPHARINGEAL Litium SS OROPHARINGEAL Quetiapine Fumarate SS OROPHARINGEAL Clonazepam C 22-Feb-2006 08:20 AM Page: 2412 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/25/05ISR Number: 4560237-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050103344 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS Date:01/25/05ISR Number: 4560238-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041206697 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cytolytic Hepatitis Risperdal PS OROPHARINGEAL Hospitalization - Drug Rash With Diamicron SS OROPHARINGEAL Initial or Prolonged Eosinophilia And Systemic Depakote SS OROPHARINGEAL Symptoms Face Oedema Hepatitis Hypersensitivity Hypotension Liver Disorder Oliguria Pulmonary Oedema Date:01/25/05ISR Number: 4560245-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041204782 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Health Risperdal PS OROPHARINGEAL 892 DAY Initial or Prolonged Hepatitis Acute Professional Pimozide SS 892 DAY Other Biperiden Hydrochloride SS OROPHARINGEAL 892 DAY Clarithromycin C Chlorpheniramine Maleate C Bromhexine Hydrochloride C Proceterol Hydrochloride C Date:01/25/05ISR Number: 4560327-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041002444 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal Consta PS INTRAMUSCULAR Blood Alkaline Phosphatase Increased Decreased Appetite Gamma-Glutamyltransferase Increased Hepatic Failure Hepatic Function Abnormal Jaundice Weight Decreased 22-Feb-2006 08:20 AM Page: 2413 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/25/05ISR Number: 4560328-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050104036 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Risperdal Consta PS INTRAMUSCULAR Life-Threatening Cardiac Failure Death Hypotension Date:01/25/05ISR Number: 4560329-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040604690 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Risperdal PS OROPHARINGEAL 1mg Drug Abuser Temesta SS OROPHARINGEAL 1mg Overdose Date:01/25/05ISR Number: 4565578-6Report Type:Direct Company Report #CTU 237752 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Risperidone PS ORAL 1.25MG , Initial or Prolonged 0.25MG B, Required ORAL Intervention to Ipratropium Bromide C Prevent Permanent Albuterol C Impairment/Damage Citalopram C Risperidone C Donepezil C Acetaminophen C Gabapentin C Tramadol C Omeprazole C Thiamine Hcl C Metoprolol C Iron (Polysaccharide Complex) C Furosemide C Clopidogrel Bisulfate C Bisacodyl C Date:01/25/05ISR Number: 4567778-8Report Type:Direct Company Report #CTU 237830 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Trazadone 50 Mg PS 50 MG DAILY Initial or Prolonged Muscle Spasms Risperidol 1 Mg SS 1 MG EVENINGS Disability Overdose Date:01/26/05ISR Number: 4561272-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050103414 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Alveolitis Allergic Initial or Prolonged Cough Other Lower Respiratory Tract Inflammation 22-Feb-2006 08:20 AM Page: 2414 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pulmonary Tuberculosis Report Source Product Role Manufacturer Route Dose Duration Risperdal Consta PS INTRAMUSCULAR Treatment started about a year ago. Melperon C OROPHARINGEAL PRN Date:01/26/05ISR Number: 4561273-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041206672 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Risperdal PS OROPHARINGEAL Hospitalization - Decreased Famotidine C UNKNOWN Initial or Prolonged Bradycardia Teprenone C UNKNOWN Hypotension Carbocisteine C UNKNOWN Liver Function Test Camostat Mesilate C UNKNOWN Abnormal Tulobuterol C UNKNOWN Pneumonia Aspiration Amantadine Respiratory Failure Hydrochloride C UNKNOWN Enalapril Maleate C UNKNOWN Clostridium Butyricum C Date:01/26/05ISR Number: 4561274-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041008024 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Megaloblastic Risperdal PS OROPHARINGEAL Initial or Prolonged Gastritis Atrophic Risperdal SS OROPHARINGEAL Haemolytic Anaemia Nitrazepam C Lymphocyte Stimulation Nitrazepam C Test Positive Sennoside C Pernicious Anaemia Chlorpromazine Promethazine C Chlorpromazine Promethazine C Chlorpromazine Promethazine C Flunitrazepam C Quazepam C Date:01/26/05ISR Number: 4561275-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050101613 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Risperdal PS Cardio-Respiratory Arrest Sultopride Conduction Disorder Hydrochloride C Convulsion Carbamazepine C Electroencephalogram Bromazepam C Abnormal Phenytoin C Epilepsy Nitrazepam C Injury Asphyxiation 22-Feb-2006 08:20 AM Page: 2415 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/05ISR Number: 4566522-8Report Type:Direct Company Report #USP 57047 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Restoril PS Tyco Healthcare TABLET Risperdal SS Janssen Pharma TABLET Date:01/26/05ISR Number: 4566525-3Report Type:Direct Company Report #CTU 238143 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Lithium Carbonate Dystonia 150mg Roxane PS Roxane ORAL 150MG QAM & Fall QHS ORAL Risperidone 4mg Jannsen SS Jannsen ORAL 7MG QHS ORAL Acetaminophen C Albuterol C Aspirin C Atrovent C Diovan C Docusate C Flovent C Levothyroxine C Lipitor C Lorazepam C Mom C Phenytoin C Ranitidine C Bisacodyl C Maalox C Date:01/27/05ISR Number: 4562643-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050104087 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS OROPHARINGEAL Atosil SS Date:01/27/05ISR Number: 4565150-8Report Type:Direct Company Report #CTU 238311 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oculogyration Risperidone PS ORAL 2MG PO Date:01/27/05ISR Number: 4565204-6Report Type:Direct Company Report #CTU 238426 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Convulsion Neonatal Risperdal PS 1 MG Drug Exposure During Cogentin 2mg Tid SS Pregnancy Prolixin Dec 25 Q 2 Forceps Delivery Wks SS Traumatic Brain Injury 22-Feb-2006 08:20 AM Page: 2416 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/27/05ISR Number: 4570314-3Report Type:Direct Company Report #CTU 238304 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperidone 4mg PS ORAL 8MG DAILY Initial or Prolonged Condition Aggravated ORAL Required Hallucination, Auditory Amantadine C Intervention to Injury Diclofenac C Prevent Permanent Mental Status Changes Impairment/Damage Renal Failure Acute Rhabdomyolysis Date:01/27/05ISR Number: 4575366-2Report Type:Direct Company Report #CTU 238296 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Angioneurotic Oedema Risperidone PS ORAL 2MG PO Date:01/28/05ISR Number: 4564365-2Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0359063A Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Paxil PS Glaxosmithkline ORAL 907 DAY Initial or Prolonged Aspartate Risperidone SS ORAL 3MG Per day Aminotransferase Fluvoxamine Maleate SS ORAL 25MG Three Increased times per day 829 DAY Blood Creatine Pl C ORAL 1G Three Phosphokinase Increased times per day 4 DAY Blood Lactate Cefzon C ORAL 300MG per day 4 DAY Dehydrogenase Increased Cold Drug Name Convulsion Unknown C UNKNOWN Coordination Abnormal Dizziness Drug Interaction Haematocrit Decreased Haemoglobin Decreased High Density Lipoprotein Decreased Hyperhidrosis Hyperreflexia Myoclonus Pyrexia Red Blood Cell Count Decreased Restlessness Serotonin Syndrome Tremor Date:01/28/05ISR Number: 4564403-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050105183 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Risperdal PS OROPHARINGEAL Initial or Prolonged Masked Facies Other Parkinsonism Pleurothotonus 22-Feb-2006 08:20 AM Page: 2417 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/28/05ISR Number: 4564404-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050105227 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperdal PS Initial or Prolonged Phosphokinase Increased Blood Pressure Fluctuation Body Temperature Increased Depression Dyspnoea White Blood Cell Count Increased Date:01/28/05ISR Number: 4564405-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050102782 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Risperdal PS OROPHARINGEAL Risperdal SS OROPHARINGEAL Zotepine C Quietapine Fumarate C Carbamazepine C Chlorpromazine Hydrochloride C Trihexyphenidyl Hydrochloride C Nitrazepam C Lorazepam C Triazolam C Mosapride Citrate C Flunitrazepam C Date:01/28/05ISR Number: 4564406-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050101615 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Risperdal PS UNKNOWN Initial or Prolonged Complete Risperdal SS UNKNOWN Other Sick Sinus Syndrome Clonazepam C Etizolam C Date:01/28/05ISR Number: 4564407-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041204782 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Risperdal PS OROPHARINGEAL 892 DAY Initial or Prolonged Hepatitis Acute Pimozide SS 892 DAY Other Nasopharyngitis Biperiden Hydrochloride SS OROPHARINGEAL 892 DAY Clarithromycin C Chlorpheniramine Maleate C Bromhexine Hydrochloride C Proceterol Hydrochloride C 22-Feb-2006 08:20 AM Page: 2418 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/28/05ISR Number: 4564408-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041006580 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Risperdal PS OROPHARINGEAL Hospitalization - Anorexia Nervosa Risperdal SS OROPHARINGEAL Initial or Prolonged Ascites Potassium C Dehydration Librax C Electrolyte Imbalance Librax C Fall Pancrease Mt 10 C Hypoxia Pancrease Mt 10 C Malnutrition Pancrease Mt 10 C Non-Cardiac Chest Pain Neurontin C Pleural Effusion Multivitamins C Renal Cell Carcinoma Multivitamins C Stage Unspecified Multivitamins C Weight Decreased Multivitamins C Multivitamins C Multivitamins C Multivitamins C Multivitamins C Vitamin E C Zinc 220 C Darvocet N-100 C Darvocet N-100 C Date:01/28/05ISR Number: 4564409-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041005281 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS OROPHARINGEAL Concerta C OROPHARINGEAL Date:01/28/05ISR Number: 4575736-2Report Type:Direct Company Report #CTU 238628 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akathisia Risperdal .5mgs Dementia Janssen PS Janssen ORAL SEE IMAGE Tardive Dyskinesia Prozac C Concerta C Date:01/31/05ISR Number: 4564973-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041002444 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal Consta PS INTRAMUSCULAR Blood Alkaline Phosphatase Increased Drug Abuser Gamma-Glutamyltransferase Increased Hepatic Failure Jaundice Liver Disorder 22-Feb-2006 08:20 AM Page: 2419 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/05ISR Number: 4564974-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040909365 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Polytraumatism Risperdal PS OROPHARINGEAL Road Traffic Accident Depakote C Depakote C Depakote C Trazodone C Trazodone C Lamictal C Lamictal C Date:01/31/05ISR Number: 4565623-8Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20050103160 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Detachment Risperdal PS Vision Blurred Risperdal SS Visual Disturbance Risperdal SS .25 mg in the morning, .5 mg in the evening Clomipramine C 25 mg tabs (2 tabs each am adn 3 tabs each evening) Date:01/31/05ISR Number: 4565624-XReport Type:Expedited (15-DaCompany Report #CH-JNJFOC-20050104558 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Risperdal PS OROPHARINGEAL Initial or Prolonged Pulmonary Oedema Molsidomin Mepha 8 C OROPHARINGEAL Renal Failure Aspirin Cardio C OROPHARINGEAL Xenalon C OROPHARINGEAL Actos C OROPHARINGEAL Oedemex C OROPHARINGEAL Zestril C OROPHARINGEAL Date:01/31/05ISR Number: 4565625-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050105258 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cyanosis Risperdal PS OROPHARINGEAL Initial or Prolonged Extrapyramidal Disorder Risperdal SS OROPHARINGEAL Other Somnolence Melperon C taken as needed Acetylsalicylacid C Antra C Date:01/31/05ISR Number: 4565626-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041007423 Age:33 YR Gender:Male I/FU:I Outcome PT Other Blood Cholesterol Increased Blood Triglycerides 22-Feb-2006 08:20 AM Page: 2420 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Report Source Product Role Manufacturer Route Dose Duration Risperdal PS OROPHARINGEAL Cogentin C OROPHARINGEAL Benadryl C OROPHARINGEAL dose taken at night Paxil Cr C OROPHARINGEAL Date:01/31/05ISR Number: 4565627-5Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20050103393 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastric Dilatation Risperdal PS Intestinal Dilatation Olanzapine SS Pneumonia Trazadone SS Sepsis Lipostat C Tenormin C Tritace C Aspirine C Digoxine C Atrovent C Warfarin C Date:01/31/05ISR Number: 4565628-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20040602726 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperdal PS OROPHARINGEAL Initial or Prolonged Asthenia Risperdal SS OROPHARINGEAL Disability Blood Pressure Risperdal SS OROPHARINGEAL Other Fluctuation Risperdal SS OROPHARINGEAL Confusional State Erythema Faecal Incontinence Feeling Drunk Hallucination Hyperhidrosis Muscle Rigidity Retinal Scar Sensation Of Pressure Urinary Incontinence Visual Disturbance Weight Increased Date:01/31/05ISR Number: 4565834-1Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0287974-00 Age:35 YR Gender:Female I/FU:I Outcome PT Life-Threatening Chapped Lips Hospitalization - Conjunctivitis Infective Initial or Prolonged Cytolytic Hepatitis Dermatitis Exfoliative Drug Rash With Eosinophilia And Systemic Symptoms Face Oedema Hypotension 22-Feb-2006 08:20 AM Page: 2421 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lymphadenopathy Oliguria Pulmonary Oedema Report Source Product Role Manufacturer Route Dose Duration Skin Exfoliation Depakote Tablets PS ORAL 39 DAY Risperidone SS ORAL 41 DAY Gliclazide SS ORAL 18 DAY Date:01/31/05ISR Number: 4568253-7Report Type:Expedited (15-DaCompany Report #2005CG00141 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Mopral PS Initial or Prolonged Extrapyramidal Disorder Health Nootropyl SS Professional Durogesic SS Other Celebrex SS Daonil SS Deroxat SS Risperdal SS Stagid SS Glucor SS Chronadalate SS Discotrine C Xanax C Fozitec C Date:01/31/05ISR Number: 4575511-9Report Type:Direct Company Report #CTU 238697 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Insomnia Zoloft 50mg/100mg Initial or Prolonged Loss Of Libido Tabs PS ORAL 50MGX3 100X3 Restlessness ORAL Suicide Attempt Resperidol SS ORAL ORAL Weight Increased Date:02/01/05ISR Number: 4567110-XReport Type:Expedited (15-DaCompany Report #PT-JNJFOC-20050105115 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Risperdal PS Initial or Prolonged Agitation Other Coordination Abnormal Eye Movement Disorder Date:02/01/05ISR Number: 4567111-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050105222 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Risperdal PS OROPHARINGEAL tapered down Erythema from 6mg Galactorrhoea Dipiperon SS OROPHARINGEAL Hyperprolactinaemia Delix C OROPHARINGEAL Spironolacton C Amoxipen C Torem C 22-Feb-2006 08:20 AM Page: 2422 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/05ISR Number: 4567112-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041102035 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Risperdal PS OROPHARINGEAL Fatigue Gaze Palsy Hypotension Syncope Vasovagal Date:02/01/05ISR Number: 4576076-8Report Type:Direct Company Report #CTU 238778 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erection Increased Risperidone 3 Mg PS ORAL 3 MG DAILY Initial or Prolonged Painful Erection ORAL Required Seroquel C Intervention to Fluphenazine C Prevent Permanent Benztropine C Impairment/Damage Depakote C Zocor C Protonix C Asa C Date:02/02/05ISR Number: 4567912-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050105420 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Speech Disorder Solian SS Solian SS Solian SS Solian SS Solian SS 500-800 mg/day Solian SS Solian SS Solian SS Date:02/02/05ISR Number: 4567913-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050106202 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Risperdal PS OROPHARINGEAL 1 mg in am Haemoglobin Decreased and 2 mg Red Blood Cell Count (time not Decreased specified) White Blood Cell Count Lamotrigine C Decreased Depakote C Zoloft C OROPHARINGEAL Inh C Date:02/02/05ISR Number: 4568216-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041102388 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal PS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2423 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/05ISR Number: 4570251-4Report Type:Expedited (15-DaCompany Report #2004108236 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Foreign Lipitor Initial or Prolonged Urinary Retention Health (Atorvastatin) PS ORAL 40 MG (40 MG, Other Professional 1 IN 1 D), Company ORAL Representative Risperidone (Risperidone) SS ORAL 3 MG (3 MG, 1 IN 1 D), ORAL Date:02/02/05ISR Number: 4571300-XReport Type:Expedited (15-DaCompany Report #2004100399 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Consumer Neurontin Initial or Prolonged Mental Disorder (Gabapentin) PS Other Pain Risperidone Pancreatitis (Risperidone) SS ORAL ORAL Sexual Dysfunction All Other Weight Increased Therapeutic Products (All Other Therapeutic Products) C Date:02/03/05ISR Number: 4569153-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041006137 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aggression Risperdal PS OROPHARINGEAL Other Delusion Risperdal SS OROPHARINGEAL Depression Heart Rate Irregular Self-Injurious Ideation Date:02/03/05ISR Number: 4569154-0Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20041204127 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Transient Ischaemic Risperdal PS OROPHARINGEAL Initial or Prolonged Attack Clonidine C 25-25-50 mcg Other Date:02/03/05ISR Number: 4569155-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050200192 Age:73 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperglycaemia Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Respiratory Depression Other Tachycardia 22-Feb-2006 08:20 AM Page: 2424 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/05ISR Number: 4569156-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050200208 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Risperdal Consta PS INTRAMUSCULAR 6-7 month duration Risperdal SS OROPHARINGEAL Date:02/03/05ISR Number: 4569157-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050200263 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Risperdal Consta PS INTRAMUSCULAR 6-7 months duration Risperdal SS OROPHARINGEAL Date:02/03/05ISR Number: 4569158-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041202830 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Risperidone C OROPHARINGEAL Disability Risperidone C OROPHARINGEAL Other Date:02/03/05ISR Number: 4569533-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041103377 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Crohn'S Disease Risperdal PS OROPHARINGEAL Hospitalization - Death Glucotrol C Initial or Prolonged Actose C Lipitor C Asacol C Pepcid C Flexeril C Date:02/03/05ISR Number: 4572267-0Report Type:Expedited (15-DaCompany Report #MK200412-0318-1 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Foreign Anafranil Capsules Brain Oedema 25mg PS 225 MG, QD Convulsion Risperdal SS Disseminated Tricyclic Intravascular Coagulation Antidepressant C Gastrointestinal Haemorrhage Heat Stroke Loss Of Consciousness Multi-Organ Failure Muscle Spasms Neuroleptic Malignant Syndrome Overdose Renal Failure Respiratory Disorder Shock 22-Feb-2006 08:20 AM Page: 2425 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/05ISR Number: 4570453-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050106697 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Bundle Branch Block Right Risperdal PS OROPHARINGEAL Other Dizziness Risperdal SS OROPHARINGEAL Malaise Orthostatic Hypotension Palpitations Date:02/04/05ISR Number: 4570454-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050200056 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Biliary Tract Disorder Risperdal PS Initial or Prolonged Hepatitis Cholestatic Protonix C Xopenex C Date:02/04/05ISR Number: 4570455-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050105122 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Risperdal Consta PS INTRAMUSCULAR Lipids Increased Sudden Cardiac Death Date:02/04/05ISR Number: 4570456-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050101647 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS OROPHARINGEAL Dexamphetamine C Date:02/04/05ISR Number: 4570457-4Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20041105844 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Risperdal PS OROPHARINGEAL Thrombocytopenia Akineton C OROPHARINGEAL Orfidal C OROPHARINGEAL Date:02/04/05ISR Number: 4570458-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050105407 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Risperdal PS Pt. took 40 Initial or Prolonged Fall tablets Overdose (strength Suicide Attempt unspecified) in a suicide 22-Feb-2006 08:20 AM Page: 2426 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/07/05ISR Number: 4578643-4Report Type:Direct Company Report #CTU 239438 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Facial Palsy Risperdal 500 Mcg Transient Ischaemic Janssen PS Janssen ORAL 500 MCG Attack DAILY ORAL Date:02/08/05ISR Number: 4573207-0Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0519822A Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dizziness Paxil PS Glaxosmithkline ORAL 30MG Per day Initial or Prolonged Drug Withdrawal Syndrome Wellbutrin SS Glaxosmithkline Feeling Abnormal Flexeril SS Intentional Overdose Skelaxin SS Suicidal Ideation Antiinflammatory SS Suicide Attempt Aspirin SS Glaxosmithkline Theophylline SS Risperdal SS Cold Medicine SS Date:02/08/05ISR Number: 4574953-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050200697 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Risperdal PS OROPHARINGEAL Risperdal SS OROPHARINGEAL Lactulose C OROPHARINGEAL Magnesium Oxide C OROPHARINGEAL Dimeticone C OROPHARINGEAL Mosapride Citrate C OROPHARINGEAL Ascorbic Acid C Calcium Pantothenate C OROPHARINGEAL Lactulose C OROPHARINGEAL Spironolactone C OROPHARINGEAL 50-200 mg daily Omeprazole C OROPHARINGEAL Sennoside C OROPHARINGEAL Date:02/08/05ISR Number: 4574954-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040909788 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gastrointestinal Necrosis Risperdal PS OROPHARINGEAL Intestinal Obstruction Tercian SS OROPHARINGEAL Megacolon Tercian SS OROPHARINGEAL Septic Shock Lysanxia C Volvulus Of Bowel Date:02/08/05ISR Number: 4574955-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041204639 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cogwheel Rigidity Risperdal PS OROPHARINGEAL General Physical Health Deterioration Urinary Tract Infection 22-Feb-2006 08:20 AM Page: 2427 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/05ISR Number: 4574956-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040909386 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Risperdal PS OROPHARINGEAL 6 MON Hospitalization - Death Asa C Initial or Prolonged Overdose Sepsis Urinary Incontinence Urinary Retention Date:02/08/05ISR Number: 4574957-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050102302 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Risperdal PS OROPHARINGEAL Diarrhoea Tercian C Hypotension Effexor C Nausea Imovane C Pyrexia Rivotril C Vomiting Lepticur C Sulfarlem C Date:02/08/05ISR Number: 4575069-4Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0359063A Age:68 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Paxil PS Glaxosmithkline ORAL 914 DAY Initial or Prolonged Aspartate Risperidone SS ORAL 471 DAY Aminotransferase Fluvoxamine Maleate SS ORAL 25MG Three Increased times per day 829 DAY Blood Creatine Pl SS ORAL 1G Three Phosphokinase Increased times per day 4 DAY Blood Lactate Cefzon C ORAL 300MG per day 4 DAY Dehydrogenase Increased Cold Drug Name Convulsion Unknown C UNKNOWN Coordination Abnormal Dehydration Dizziness Drug Interaction Dysstasia General Physical Health Deterioration High Density Lipoprotein Decreased Hyperhidrosis Hyperreflexia Mental Status Changes Myoclonus Pyrexia Restlessness Serotonin Syndrome Somnolence Treatment Noncompliance Tremor 22-Feb-2006 08:20 AM Page: 2428 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/05ISR Number: 4579211-0Report Type:Direct Company Report #CTU 239743 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Respiridone PS ORAL 4 MG PO Initial or Prolonged EVENINGS Date:02/09/05ISR Number: 4575588-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050200395 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL 3 DAY Hospitalization - Incoherent Risperdal SS OROPHARINGEAL 3 DAY Initial or Prolonged Aricept C Date:02/09/05ISR Number: 4575589-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050200408 Age:97 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Risperdal PS OROPHARINGEAL 2 YR Initial or Prolonged Drooling Risperdal SS OROPHARINGEAL 2 YR Epilepsy Digoxin C Nausea Cardizem C Parkinson'S Disease Cardizem C Cardizem C Date:02/09/05ISR Number: 4575590-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040501364 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acne Risperdal PS OROPHARINGEAL Blood Prolactin Increased Risperdal SS OROPHARINGEAL Constipation Risperdal SS OROPHARINGEAL Decreased Appetite Wellbutrin C Delusion Depression Diarrhoea Disturbance In Attention Galactorrhoea Gastric Polyps Hallucination Headache Hepatic Lesion Infertility Insomnia Malaise Memory Impairment Panic Attack Paranoia Pituitary Tumour Benign Vision Blurred Visual Disturbance Weight Decreased 22-Feb-2006 08:20 AM Page: 2429 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/05ISR Number: 4575753-2Report Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0370042A Age:51 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Nytol PS Glaxosmithkline ORAL Initial or Prolonged Hyponatraemia Risperidone SS INTRAMUSCULAR 25MG Every Overdose two weeks Date:02/09/05ISR Number: 4575977-4Report Type:Expedited (15-DaCompany Report #JP-SOLVAY-00304004218 Age:25046 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Luvox 25 PS ORAL Daily dose: Initial or Prolonged Anaemia 75 Anorexia milligram(s) 837 DAY Aspartate Pl Granule C ORAL Daily dose: 3 Aminotransferase gram(s) 4 DAY Increased Cefzone C ORAL Daily dose: Blood Alkaline 300 Phosphatase Decreased milligram(s) 4 DAY Blood Creatine Paxil I ORAL Daily dose: Phosphokinase Increased 10 Blood Lactate milligram(s) 39 DAY Dehydrogenase Increased Paxil I ORAL Daily dose: Convulsion 20 Drug Interaction milligram(s) 20 DAY Fatigue Paxil I ORAL Daily dose: Hyperreflexia 40 Medication Error milligram(s) 523 DAY Mental Status Changes Paxil I ORAL Daily dose: Nasopharyngitis 20 Serotonin Syndrome milligram(s) 308 DAY Somnolence Paxil I ORAL Daily dose: Tremor 10 milligram(s) 24 DAY Risperidone I ORAL Daily dose: 3 milligram(s) 2 YR Date:02/09/05ISR Number: 4577252-0Report Type:Expedited (15-DaCompany Report #2004AL000960 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Diastolic Literature Hydramine Cough Decreased Health Syrup Cardiac Arrest Professional (Diphenhydramine Completed Suicide Hydrochloride Cough Electrocardiogram St Syrup) (Alpharma) PS Alpharma ORAL PO Segment Elevation Hydramine Elixir Heart Rate Increased (Diphenhydramine Loss Of Consciousness Hydrochloride Multiple Drug Overdose Elixir) (Alpharma) SS Alpharma ORAL PO Intentional Paroxetine SS ORAL PO Venlafaxine SS ORAL PO Ethanol SS ORAL PO Risperidone SS ORAL PO 22-Feb-2006 08:20 AM Page: 2430 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/05ISR Number: 4577755-9Report Type:Expedited (15-DaCompany Report #2004AL000570 Age:49 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Kadian (Morphine Cardio-Respiratory Arrest Health Sulfate Sustained Completed Suicide Professional Release) Capsules, Overdose 100 Mg (Alpharma) PS Alpharma ORAL PO Pupil Fixed Trazodone Hydrochloride Tablets, 100 Mg (Purepac) SS Purepac ORAL PO Benzodiazepine Derivatives SS ORAL PO Diazepam Tablets Ups, 10 Mg (Purepac) SS Purepac ORAL PO Risperidone SS ORAL PO Levodopa SS ORAL PO Cyclobenzaprine SS ORAL PO Trihexyphenidyl SS ORAL PO Propoxyphene SS ORAL PO Venlafaxine SS ORAL PO Gabapentin SS ORAL PO Date:02/09/05ISR Number: 4580197-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050200697 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Risperdal PS OROPHARINGEAL Risperdal SS OROPHARINGEAL Lactulose C OROPHARINGEAL Magnesium Oxide C OROPHARINGEAL Dimeticone C OROPHARINGEAL Mosapride Citrate C OROPHARINGEAL Ascorbic Acid C Calcium Pantothenate C OROPHARINGEAL Lactulose C OROPHARINGEAL Spironolactone C OROPHARINGEAL 50-200 mg daily Omeprazole C OROPHARINGEAL Sennoside C OROPHARINGEAL Date:02/09/05ISR Number: 4580198-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040909788 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Risperdal PS OROPHARINGEAL Colonic Tercian SS OROPHARINGEAL Pseudo-Obstruction Tercian SS OROPHARINGEAL Gastrointestinal Necrosis Lysanxia C Haemodynamic Instability Intestinal Ischaemia Intestinal Obstruction Megacolon Oxygen Saturation Decreased Septic Shock Volvulus Of Bowel 22-Feb-2006 08:20 AM Page: 2431 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/05ISR Number: 4580199-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041204639 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other C-Reactive Protein Risperdal PS OROPHARINGEAL Increased Cogwheel Rigidity General Physical Health Deterioration Hyperthermia Urinary Tract Infection Date:02/09/05ISR Number: 4580200-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040909386 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Risperdal PS OROPHARINGEAL 6 MON Hospitalization - Death Asa C Initial or Prolonged Overdose Sepsis Urinary Incontinence Urinary Retention Date:02/09/05ISR Number: 4580201-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050102302 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Risperdal PS OROPHARINGEAL Diarrhoea Tercian C Hypotension Effexor C Nausea Imovane C Pyrexia Rivotril C Vomiting Lepticur C Sulfarlem C Date:02/10/05ISR Number: 4576678-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050200565 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Carotid Artery Occlusion Risperdal PS Cerebral Atrophy Date:02/10/05ISR Number: 4576679-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050201007 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Neoplasm Risperdal PS OROPHARINGEAL Date:02/10/05ISR Number: 4576680-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050101615 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Risperdal PS UNKNOWN Initial or Prolonged Complete Risperdal SS UNKNOWN Other Sick Sinus Syndrome Clonazepam C Sinus Arrest Etizolam C Syncope Vasovagal 22-Feb-2006 08:20 AM Page: 2432 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/10/05ISR Number: 4576681-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041200939 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal PS OROPHARINGEAL Phosphokinase Increased Risperdal SS OROPHARINGEAL Catatonia Flunitrazepam C OROPHARINGEAL Chest Pain Chinese Medicines C Cogwheel Rigidity Sulpiride C OROPHARINGEAL Drug Interaction Atorvastatin Calcium I Hallucination Hallucination, Visual Incoherent Myoglobin Blood Increased Pollakiuria Rhabdomyolysis Stupor Syncope Tremor Date:02/10/05ISR Number: 4579590-4Report Type:Expedited (15-DaCompany Report #2004AL000806 Age:33 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anion Gap Increased Literature Alprazolam Tablets Hospitalization - Blood Bicarbonate Health Usp, 2 Mg (Purepac) PS Purepac ORAL PO Initial or Prolonged Decreased Professional Risperidone SS ORAL PO Blood Glucose Increased Tranylcypromine SS ORAL PO Blood Ph Decreased Clonazepam Tablets Blood Potassium Increased Usp, 2 Mg (Purepac) SS Purepac ORAL PO Blood Pressure Diastolic Decreased Coma Completed Suicide Computerised Tomogram Abnormal Decerebration Grand Mal Convulsion Hyperthermia Hypotension Multiple Drug Overdose Intentional Muscle Rigidity Nystagmus Po2 Increased Pupillary Reflex Impaired Respiratory Rate Decreased Sinus Tachycardia Status Epilepticus Therapy Non-Responder Date:02/10/05ISR Number: 4579620-XReport Type:Direct Company Report #CTU 240096 Age:25 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Cogwheel Rigidity Coma Hyperthermia 22-Feb-2006 08:20 AM Page: 2433 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Locked-In Syndrome Mental Status Changes Neuroleptic Malignant Report Source Product Role Manufacturer Route Dose Duration Syndrome Haloperidol 2mg/Ml Somnolence Ortho Mcneil Pharmaceuticals PS Ortho Mcneil Pharmaceuticals INTRAVENOUS 100MG (20ML) IV CONT INFUSED 5MG IV Q 1 H PRN, 1 MG IV Q 1 H Risperidone 0.5mg And 1 Mg Janssen Pharmaceuticals SS Janssen Pharmaceuticals ORAL 0.5MG PO BID 3 D 5 MG PO BID X 5 D Risperidone 1 Mg Janssen Pharmaceuticals SS Janssen Pharmaceuticals ORAL 1MG PO BID X1 D Linezolid C Levofloxacin C Cefepime C Azithromycin C Metronidazole C Bacitracin Zinc Ointment C Metoclopramide C Sulcrafate C Dalteparin C Docusate Sodium C Ferrous Sulfate C Magnesium Hydroxide C Fentanyl C Promethazine Hcl C Bisacodyl C Buspirone C Tpn C Date:02/10/05ISR Number: 4579640-5Report Type:Expedited (15-DaCompany Report #MESA-2004-008 Age:75 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Pulmonary Oedema Health Salofalk Hospitalization - Agranulocytosis Professional (Mesalamine) Tablets PS ORAL 500 MG 2 Initial or Prolonged Cardiogenic Shock TABLETS QID Delirium PO Infection Plavix (Clopidogrel Myocardial Infarction Bisulfate) SS Neutropenia Salofalk Enema SS Risperdal (Risperidone) SS Syntroid (Levothyroxine Sodium) C Cortenema (Hydrocortisone) C Hydrochlorothiazide C 22-Feb-2006 08:20 AM Page: 2434 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Desyrel (Trazodone Hcl) C Aspirin C Iraxure C Nitroglycerine Isosorbide C Monocor (Bisoprolol Fumarate) C Metformin C Date:02/10/05ISR Number: 4579754-XReport Type:Expedited (15-DaCompany Report #2004AL000733 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Clonidine Haemodialysis Health Hydrochloride Hyperglycaemia Professional Tablets Usp, 0.3 Mg Hypotension (Purepac) PS Purepac ORAL PO Multiple Drug Overdose Amlodipine/Benazepri No Therapeutic Response l SS ORAL PO Renal Failure Glimepiride SS ORAL PO Prometh Syrup Plain (Promethazine Hcl Syrup Usp, 6.25 Mg/5 Ml) (Alpharma) SS Alpharma ORAL PO Diazepam Tablets Us, 10 Mg (Purepac) SS Purepac ORAL PO Lorazepam Tablets Usp, 2 Mg (Purepac) SS Purepac ORAL PO Riseperidone SS ORAL PO Escitalopram SS ORAL PO Date:02/10/05ISR Number: 4579797-6Report Type:Expedited (15-DaCompany Report #DSA_25742_2005 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disorientation Foreign Temesta PS ORAL 1 MG Q DAY PO Initial or Prolonged Dyskinesia Health Temesta SS ORAL DF PO Extrapyramidal Disorder Professional Endotelon SS ORAL 2 DF Q DAY PO Fall Other Plavix SS ORAL 1 DF Q DAY PO Gait Disturbance Risperdal SS ORAL 1 MG Q DAY PO Solian SS ORAL 1 DF Q DAY PO Tareg SS ORAL 1 DF Q DAY PO Date:02/11/05ISR Number: 4578150-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050200946 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Risperdal PS OROPHARINGEAL Initial or Prolonged Cardiac Failure Clozapine SS OROPHARINGEAL Congestive Clozapine SS OROPHARINGEAL (drug was Cold Sweat stopped on Fall 25-Oct-04 and Sedation restarted on 09-Nov-04.) Seroquel C 22-Feb-2006 08:20 AM Page: 2435 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/05ISR Number: 4578152-2Report Type:Expedited (15-DaCompany Report #PT-JNJFOC-20050105115 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Risperdal PS OROPHARINGEAL Initial or Prolonged Agitation Other Coordination Abnormal Eye Movement Disorder Date:02/11/05ISR Number: 4578153-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050201372 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Pregnancy Risperdal Consta SS INTRAMUSCULAR Unevaluable Event Date:02/11/05ISR Number: 4578154-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050201377 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypothermia Risperdal PS OROPHARINGEAL Disability Lower Respiratory Tract Ranitidine C Other Infection Paracetamol C Two to be Peripheral Ischaemia taken four times a day as required Lactulose C Date:02/11/05ISR Number: 4578155-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041205328 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Risperdal PS OROPHARINGEAL Initial or Prolonged Anger Risperdal SS OROPHARINGEAL Drug Interaction Risperdal Consta SS INTRAMUSCULAR Freezing Phenomenon Plavix C Injection Site Pain Welbutrin C Pain In Extremity Protonix C Polydipsia Tegretol C Schizophrenia Suicidal Ideation Treatment Noncompliance Date:02/11/05ISR Number: 4578473-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050200811 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Risperdal PS Initial or Prolonged Body Temperature Euthyrox SS Other Increased Akineton Ret SS C-Reactive Protein Leponex SS Increased Leponex SS Cardiac Failure Chronic Leponex SS Malaise Leponex SS Myocarditis Leponex SS Leponex SS Zyprexa SS 22-Feb-2006 08:20 AM Page: 2436 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa SS Zyprexa SS Zyprexa SS Zyprexa SS Tavor SS Tavor SS Tavor SS Tavor SS Date:02/11/05ISR Number: 4578474-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050201113 Age:73 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alcoholism Risperdal PS Bone Marrow Disorder Risperdal SS Bone Marrow Toxicity Risperdal SS Drug Interaction Risperdal SS Laceration Tavor C Pancytopenia Tavor C Suicide Attempt Ass C Xanef C Kalinor C Unat C Ass C Tavor C Tavor C Remergil I Remergil I Remergil I Date:02/11/05ISR Number: 4578475-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041002444 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal Consta PS INTRAMUSCULAR Decreased Appetite Drug Abuser Hepatic Failure Hepatic Function Abnormal Jaundice Weight Decreased Date:02/11/05ISR Number: 4578476-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050202482 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Parkinson'S Disease Risperdal PS OROPHARINGEAL Date:02/11/05ISR Number: 4580253-XReport Type:Expedited (15-DaCompany Report #GXKR2003GB00449 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Lorazepam (Ngx) Initial or Prolonged Sedation Health (Lorazepam) Unknown PS ORAL 1 MG, QHS, Somnolence Professional ORAL Urinary Tract Infection Other Fluphenazine (Fluphenazine) SS INTRAMUSCULAR 25 MG, 22-Feb-2006 08:20 AM Page: 2437 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report INTRAMUSCULAR Risperidone (Risperidone) SS ORAL ORAL Date:02/11/05ISR Number: 4582521-4Report Type:Direct Company Report #CTU 240207 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drooling Risperdal PS ORAL 4 MG PO HS Extrapyramidal Disorder Lithium SS 300 M Q AM AND 600 MG Q AM Date:02/14/05ISR Number: 4579687-9Report Type:Expedited (15-DaCompany Report #JP-ABBOTT-05P-087-0285506-00 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ammonia Increased Depakene PS ORAL 15 DAY Life-Threatening Ascites Bicamol SS ORAL 15 DAY Hospitalization - Bradycardia Vegetamin SS ORAL 78 DAY Initial or Prolonged Condition Aggravated Risperidone SS ORAL 15 DAY Other Hepatic Function Abnormal Carbamazepine SS ORAL 15 DAY Hepatitis Acute Diazepam SS ORAL 60 DAY Hypercapnia Sulpiride SS ORAL 50 DAY Hypoxia Quetiapine SS ORAL 1 DAY Jaundice Chlorpromazine C ORAL 53 DAY Logorrhoea Flunitrazepam C ORAL 78 DAY Multi-Organ Failure Bromperidol C ORAL 53 DAY Neuroleptic Malignant Promethazine Syndrome Hydrochloride C ORAL 53 DAY Oliguria Pneumonia Renal Impairment Sputum Retention Date:02/14/05ISR Number: 4579849-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041103369 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Risperdal PS UNKNOWN Constipation Trazodone SS Disseminated Metoprolol C Intravascular Coagulation Captopril C Gastrointestinal Lorazepam C Haemorrhage Indapamide C Hypokalaemia Lasix C Hyponatraemia Potassium C Intestinal Obstruction Leukocytosis Metabolic Acidosis Myocardial Infarction Septic Shock Sleep Disorder Syncope Vasovagal Tardive Dyskinesia 22-Feb-2006 08:20 AM Page: 2438 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/05ISR Number: 4579850-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041200186 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Risperdal PS OROPHARINGEAL Deep Vein Thrombosis Risperdal SS OROPHARINGEAL Dyspnoea Ortho Tri-Cyclen SS Pain In Extremity Seroquel C OROPHARINGEAL Pulmonary Embolism Carbatrol C OROPHARINGEAL Vaginal Infection Zithromax C OROPHARINGEAL Depo-Provera C INTRAMUSCULAR Date:02/14/05ISR Number: 4580002-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050201048 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal PS OROPHARINGEAL Initial or Prolonged Dysstasia Haldol Decanoas SS INTRAMUSCULAR Fall Imovane C Hypotension Tegretol C Temesta C Parkinane C Tercian I OROPHARINGEAL Tercian I OROPHARINGEAL Date:02/14/05ISR Number: 4580003-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050201739 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Risperdal PS OROPHARINGEAL Initial or Prolonged Ileus Risperdal SS OROPHARINGEAL Schizophrenia Chlorpromazine Hydrochloride C OROPHARINGEAL Chlorpromazine Hydrochloride C OROPHARINGEAL Date:02/14/05ISR Number: 4580399-6Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0493277A Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Galactorrhoea Lamictal PS Glaxosmithkline ORAL 25MG Twice Hypertrophy Breast per day Risperdal SS 1MG Three times per day Klonopin C Depakote Er C Remeron C Effexor Xr C Ambien C Ranitidine C Glaxosmithkline Allesse C Colace C 22-Feb-2006 08:20 AM Page: 2439 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/05ISR Number: 4580412-6Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0493955A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drooling Lamictal PS Glaxosmithkline ORAL Risperdal SS Multiple Medications C Date:02/14/05ISR Number: 4580909-9Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0515757A Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Lamictal PS Glaxosmithkline ORAL Photosensitivity Reaction Risperdal SS Date:02/14/05ISR Number: 4581793-XReport Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0501198A Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Alopecia Lamictal PS Glaxosmithkline ORAL 200MG Per day 666 DAY Risperidal SS ORAL 1MG per day Lexapro SS ORAL 20MG per day Centrum Silver C Neurontin C 600MG per day Klonopin C Adderall C Synthroid C Glaxosmithkline .025MG per day Omega 3 Fatty Acids C Glaxosmithkline Vitamin E C Date:02/14/05ISR Number: 4581970-8Report Type:Expedited (15-DaCompany Report #DE-ABBOTT-05P-062-0290030-00 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dependence Akineton Tabletten PS ORAL Initial or Prolonged Fatigue Ergenyl SS ORAL Multiple Drug Overdose Risperidone SS ORAL Intentional Hashish SS Suicide Attempt Date:02/14/05ISR Number: 4585435-9Report Type:Expedited (15-DaCompany Report #6012937 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Cardensiel Initial or Prolonged Fall Health (Bisoprolol) PS ORAL ORAL (DOSAGE Hypotension Professional FORMS, 1 IN 1 Malaise Other D) Risperdal (Risperidone) SS ORAL ORAL (DOSAGE FORMS, 1 IN 1 D) Seropram (Citalopram Hydrobromide) SS ORAL ORAL (DOSAGE FORMS, 1 IN 1 D) 22-Feb-2006 08:20 AM Page: 2440 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Effexor (Venlafaxine Hydrochloride) SS ORAL ORAL (DOSAGE FORMS, 2 IN 1 D) Depakote (Valproate Semisodium) C Reminyl (Galantamine) C Date:02/14/05ISR Number: 4585827-8Report Type:Expedited (15-DaCompany Report #GXKR2003GB00449 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Lorazepam (Ngx) Initial or Prolonged Sedation Health (Lorazepam) PS ORAL 1 MG, QHS, Urinary Tract Infection Professional ORAL Other Fluphenazine (Fluphenazine) SS INTRAMUSCULAR 25 MG, INTRAMUSCULAR Risperidone(Risperid one) SS ORAL ORAL Date:02/15/05ISR Number: 4582497-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050201870 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Risperdal PS OROPHARINGEAL Initial or Prolonged Aggression Risperdal Consta SS OTHER Agitation Cardiac Failure Congestive Irritability Paranoia Polydipsia Urinary Incontinence Date:02/15/05ISR Number: 4582498-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050201895 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal Consta PS Breast Cancer Date:02/15/05ISR Number: 4582499-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041200407 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal PS OROPHARINGEAL Risperdal SS OROPHARINGEAL Lipitor C OROPHARINGEAL Micardis C OROPHARINGEAL Acetylsalicylic Acid C OROPHARINGEAL Plavix C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2441 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/15/05ISR Number: 4587323-0Report Type:Expedited (15-DaCompany Report #2005AP00868 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Angioneurotic Oedema Foreign Atenolol PS 25 MG DAILY Intervention to Dry Skin Health Risperidone SS 2 MG DAILY Prevent Permanent Erythema Professional Fluvoxamine Maleate SS 100 MG DAILY Impairment/Damage Skin Fissures Other Clozapine SS 50 MG DAILY Swollen Tongue Zolpidem Tartrate SS 100 MG DAILY Date:02/15/05ISR Number: 4589187-8Report Type:Direct Company Report #CTU 240445 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Abdominal Pain Upper Respirdal Shot/ 21mg PS Diarrhoea Vomiting Date:02/16/05ISR Number: 4583686-0Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12850202 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Apgar Score Low Captea Tabs PS Apothecon ORAL 0.5 U tablets Other Choking Mepronizine SS ORAL 1 tablet per Cognitive Deterioration day Cyanosis Seloken SS ORAL 50 mg Depressed Mood tablets; 100 Dysphagia mg per day Risperdal SS ORAL 3 YR Xanax SS ORAL Kardegic SS ORAL 3 YR Date:02/16/05ISR Number: 4583816-0Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20050201399 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Stem Haemorrhage Risperdal Consta PS INTRAMUSCULAR Life-Threatening Date:02/16/05ISR Number: 4583817-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050202110 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Status Epilepticus Risperdal PS OROPHARINGEAL Hospitalization - Suicide Attempt Risperdal SS OROPHARINGEAL Initial or Prolonged Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Flunitrazepam C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2442 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL Nitrazepam C OROPHARINGEAL Nitrazepam C OROPHARINGEAL Famotidine C OROPHARINGEAL 52 DAY Famotidine C OROPHARINGEAL 52 DAY Clonazepam C Date:02/16/05ISR Number: 4583868-8Report Type:Expedited (15-DaCompany Report #PHNU2005DE00955 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Lioresal PS Novartis Sector: Consciousness Pharma ORAL 10 mg, QD (pulverized) 1440 MIN Risperdal SS ORAL 1 mg, QD (pulverized) 1440 MIN Durogesic C Date:02/16/05ISR Number: 4583978-5Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20050201419 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS Venlafaxine C Date:02/16/05ISR Number: 4583979-7Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20050202688 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Potassium Decreased Risperdal PS OROPHARINGEAL Neutrophil Count Decreased Platelet Count Decreased Date:02/17/05ISR Number: 4585264-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040907721 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Risperdal PS OROPHARINGEAL Corrected Interval Risperdal SS OROPHARINGEAL Prolonged Risperdal SS OROPHARINGEAL Electrocardiogram Qt Depakote C Prolonged Colace C Mavik C Toprol Xl C Aldactone C Klonopin C Flexaril C Symmetrel C 22-Feb-2006 08:20 AM Page: 2443 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pepcid C Ecotrin C Albuteral C RESPIRATORY (INHALATION) Nizoral C Bethamethasone C Darvocet C Darvocet C Date:02/17/05ISR Number: 4585265-8Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20040501168 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coordination Abnormal Risperidone PS OROPHARINGEAL stopped for a Initial or Prolonged Csf Pressure Increased few days for Other Depression dechallenge Headache Risperidone SS OROPHARINGEAL Hypomania Lithium Carbonate SS OROPHARINGEAL Hypothyroidism Risperidone SS OROPHARINGEAL re-started Intervertebral Disc after Protrusion dechallenge Intracranial Pressure Antitriptyline C OROPHARINGEAL Increased Metformin C OROPHARINGEAL Papilloedema Retinal Haemorrhage Therapeutic Response Decreased Date:02/17/05ISR Number: 4585698-XReport Type:Expedited (15-DaCompany Report #PHBS2005JP00514 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Acute Tegretol PS Novartis Sector: Cardio-Respiratory Arrest Pharma ORAL 400 mg, BID Conduction Disorder Risperdal SS ORAL 12 mg, QD Sudden Death Barnetil SS ORAL 300 mg, TID Lodopin C ORAL 450 mg/day Aleviatin C ORAL 250 mg/day Levotomin C ORAL 300 mg/day Date:02/17/05ISR Number: 4585823-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050203172 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Risperdal Consta PS INTRAMUSCULAR Syndrome Date:02/17/05ISR Number: 4585979-XReport Type:Expedited (15-DaCompany Report #DE-ABBOTT-05P-062-0290018-00 Age:53 YR Gender:Male I/FU:I Outcome PT Hospitalization - Atrial Fibrillation Initial or Prolonged Body Temperature Increased C-Reactive Protein Increased Cardiac Failure 22-Feb-2006 08:20 AM Page: 2444 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Myocarditis Report Source Product Role Manufacturer Route Dose Duration Akineton Retard PS ORAL 26 DAY Levothyroxine Sodium SS ORAL 49 DAY Risperidone SS ORAL 31 DAY Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Olanzapine SS ORAL 41 DAY Olanzapine SS ORAL 41 DAY Olanzapine SS ORAL 41 DAY Olanzapine SS ORAL 41 DAY Olanzapine SS ORAL 41 DAY Lorazepam SS ORAL Lorazepam SS ORAL Lorazepam SS ORAL Lorazepam SS ORAL Date:02/17/05ISR Number: 4586841-9Report Type:Direct Company Report #CTU 240691 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dry Mouth Risperidone 2mg Hospitalization - Erectile Dysfunction Tablet Janssen Initial or Prolonged Photosensitivity Reaction Pharmaceutical PS Janssen Disability Rash Pharmaceutical ORAL 2MG TWICE Tremor DAILY ORAL Date:02/17/05ISR Number: 4589693-6Report Type:Expedited (15-DaCompany Report #DSA_25851_2005 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Foreign Tavor PS ORAL 50 MG ONCE PO Initial or Prolonged Phosphokinase Increased Health Risperdal SS ORAL DF ONCE PO Blood Creatinine Professional Ximovan SS ORAL 90 MG ONCE PO Increased Other Blood Urea Increased Contusion Dehydration Fall Intentional Overdose Somnolence Date:02/17/05ISR Number: 4589695-XReport Type:Expedited (15-DaCompany Report #2005AP01116 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Suicidal Ideation Foreign Seroquel PS Intervention to Health Avanza SS ORAL 60 MG DAILY Prevent Permanent Professional PO Impairment/Damage Other Risperidone SS 22-Feb-2006 08:20 AM Page: 2445 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/05ISR Number: 4590014-3Report Type:Expedited (15-DaCompany Report #2004AP05470 Age:25 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ascites Foreign Seroquel PS ORAL 100 MG TID PO Life-Threatening Cardiac Disorder Health Tegretol SS ORAL 100 MG TID PO Hospitalization - Condition Aggravated Professional Horizon SS ORAL 5 MG QID PO Initial or Prolonged Hepatic Function Abnormal Other Silece SS ORAL 2 MG BID PO Hepatitis Acute Hirnamin SS ORAL 5 MG TID PO Mental Disorder Vegetamin A SS Multi-Organ Failure Risperdal SS ORAL 2 MG TID PO Neuroleptic Malignant Dogmatyl SS ORAL 100 ,G TID PO Syndrome Depakene-R SS ORAL 200 MG TID PO Pneumonia Bacterial Glycyron C Psychosomatic Disease Dasen C Date:02/17/05ISR Number: 4590258-0Report Type:Expedited (15-DaCompany Report #6012941 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Foreign Euthyrox Initial or Prolonged C-Reactive Protein Health Increased Professional (Levothyroxine Cardiac Failure Other Sodium) PS ORAL 100 MG ORAL 50 DAY Myocarditis Risperdal (Risperidone) SS 4 MG Akineton Ret (Biperiden Hydrochloride) SS ORAL 1 DOSE FORMS ORAL 26 DAY Leponex (Clozapine) SS SEE IMAGE 1 DAY Zyprexa (Olanzapine) SS SEE IMAGE 15 DAY Tavor (Lorazepam) SS SEE IMAGE 21 DAY Date:02/17/05ISR Number: 4604467-5Report Type:Periodic Company Report #S04-USA-07565-01 Age: Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Anorexia Health Namenda (Memantine) PS ORAL 10 MG QD PO Nausea Professional Namenda (Memantine) SS ORAL 5 MG QD PO Company Zyprexa (Olanzapine) SS Representative Risperdal (Risperidone) SS Date:02/18/05ISR Number: 4586926-7Report Type:Expedited (15-DaCompany Report #FI-JNJFOC-20050201453 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Systemic Lupus Risperdal PS Initial or Prolonged Erythematosus 22-Feb-2006 08:20 AM Page: 2446 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/05ISR Number: 4586927-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050202276 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Injection Site Ulcer Risperdal Consta PS INTRAMUSCULAR < 2 years Risperdal Consta SS INTRAMUSCULAR Date:02/18/05ISR Number: 4586928-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050202281 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Biliary Cirrhosis Primary Risperdal PS Risperdal SS Date:02/18/05ISR Number: 4586929-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050203175 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal Consta PS INTRAMUSCULAR Date:02/18/05ISR Number: 4586930-9Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20041104816 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypotension Risperdal PS OROPHARINGEAL Supraventricular Risperdal SS OROPHARINGEAL Tachycardia Date:02/18/05ISR Number: 4591679-2Report Type:Expedited (15-DaCompany Report #2004UW23985 Age:32 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Drug Ineffective Study Risperidone Intervention to Suicidal Ideation Health Janssen PS Janssen ORAL 1MG BID PO Prevent Permanent Professional Bupropion C Impairment/Damage Ambien C Date:02/18/05ISR Number: 4594089-7Report Type:Expedited (15-DaCompany Report #FRWYE420514FEB05 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Health Effexor (Venlafaxine Initial or Prolonged Fall Professional Hydrochloride, Other Hypotension Other Unspec, 0) PS ORAL 2 DOSE 1X PER Malaise 1 DAY Bisoprolol Fumarate(Bisoprolol Fumarate) SS ORAL 1 DOS 1X PER 1 DAY ORAL Risperdal (Risperi8dine) SS ORAL 1 DOSE 1X PER 1 DAY Seropram(Citalopram Hydrobromide) SS ORAL 1 DOSE 1X PER 1 DAY Depakote (Valproate Semisodium) C 22-Feb-2006 08:20 AM Page: 2447 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Reminyl (Galantamine) C Date:02/22/05ISR Number: 4588358-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050203109 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bone Marrow Depression Risperdal PS OROPHARINGEAL Initial or Prolonged Dyspnoea Exertional Haldol SS OROPHARINGEAL 2 mg/ml Epistaxis Akineton Retard SS OROPHARINGEAL Epstein-Barr Virus Stagid SS OROPHARINGEAL Antibody Positive Atarax SS OROPHARINGEAL Metrorrhagia Levothyrox C Petechiae Date:02/22/05ISR Number: 4588359-6Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20050203227 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Swelling Risperdal Consta PS Hyperprolactinaemia Psychotic Disorder Date:02/22/05ISR Number: 4588360-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050203426 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Haemorrhage Risperdal PS OROPHARINGEAL Convulsion Depressed Level Of Consciousness Fall Haemolytic Anaemia Date:02/22/05ISR Number: 4588361-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040810131 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophil Percentage Risperdal PS OROPHARINGEAL Decreased Biperiden Mean Cell Haemoglobin Hydrochloride C OROPHARINGEAL Increased Alprazolam C OROPHARINGEAL Zinc Sulphate Turbidity Flunitrazepam C OROPHARINGEAL Decreased Date:02/22/05ISR Number: 4588362-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050102302 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Risperdal PS OROPHARINGEAL Drug Interaction Effexor SS OROPHARINGEAL Electrocardiogram Qt Sulfarlem SS Prolonged Imovane C Gastroenteritis Lepticur C Hypotension Rivotril C Tercian I 22-Feb-2006 08:20 AM Page: 2448 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/05ISR Number: 4588622-9Report Type:Expedited (15-DaCompany Report #PHBS2005DE02352 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Clozapine PS Novartis Sector: Disturbance In Attention Pharma UNKNOWN 250 mg/d Libido Decreased Lorazepam SS UNKNOWN 1 mg/d Weight Increased Haloperidol SS Zotepine SS Risperidone SS UNKNOWN 6 mg/d Date:02/22/05ISR Number: 4588625-4Report Type:Expedited (15-DaCompany Report #PHEH2005US02200 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Clozaril PS Novartis Sector: Drug Toxicity Pharma ORAL 400 mg, QD Pulmonary Oedema Abilify C 30 mg, QD Lamotrigine C 100 mg, QHS Artane C UNK mg, QD Depakote C 1500 mg, QD Risperdal I 3 mg, QD Klonopin I 1 mg, QD Paxil I 215 mg, QD Date:02/22/05ISR Number: 4588791-0Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20050203173 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Swelling Risperdal PS OROPHARINGEAL Hyperprolactinaemia Risperdal SS OROPHARINGEAL Dipiperon C Date:02/22/05ISR Number: 4588793-4Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20050203212 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Breast Neoplasm Risperdal PS Hyperprolactinaemia Date:02/22/05ISR Number: 4588794-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050203675 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Complication Risperdal PS OROPHARINGEAL Date:02/22/05ISR Number: 4588798-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050202918 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Reminyl PS OROPHARINGEAL Patient has been taking reminyl for 3 and half years. Risperdal SS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2449 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/22/05ISR Number: 4590967-3Report Type:Direct Company Report #CTU 241004 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Respirodal 2mg Blood Cholesterol Janssen PS Janssen ORAL 2 MG DAILY Increased ORAL Blood Triglycerides Lipitor C Increased Mental Impairment Pharmaceutical Product Complaint Date:02/22/05ISR Number: 4594152-0Report Type:Expedited (15-DaCompany Report #S05-FRA-00515-01 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Seropram (Citalopram Initial or Prolonged Fall Health Hydrobromide) PS ORAL 20 MG QD PO Hypotension Professional Risperdal Malaise Other (Risperidone) SS ORAL 1 QD PO Effexor (Venlafaxine Hydrochloride) SS ORAL 1 BID PO Cardensiel (Bisoprolol Fumarate) SS ORAL 1 QD PO Depakote (Valproate Semisodium) C Galantamine C Date:02/23/05ISR Number: 4589528-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050203811 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Risperdal PS INTRA-UTERINE Neonatal Date:02/23/05ISR Number: 4589529-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050203426 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Haemorrhage Risperdal PS OROPHARINGEAL Convulsion Sodium Valproate C Depressed Level Of Zonisamide C Consciousness Sennoside C Fall Clobazam C Haemolytic Anaemia Phenytoin C Date:02/23/05ISR Number: 4589836-4Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0290843-00 Age:37 YR Gender:Female I/FU:I Outcome PT Hospitalization - Aplasia Initial or Prolonged Biopsy Bone Marrow Abnormal Bone Marrow Myelogram Abnormal Dyspnoea Exertional 22-Feb-2006 08:20 AM Page: 2450 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Epistaxis Gingival Bleeding Metrorrhagia Report Source Product Role Manufacturer Route Dose Duration Petechiae Akineton PS ORAL Risperidone SS ORAL 3 MON Metformin SS ORAL 3 YR Hydroxyzine Hydrochloride SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL 15 to 20 drops Levothyroxine C ORAL Date:02/23/05ISR Number: 4591108-9Report Type:Direct Company Report #CTU 241055 Age:27 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Metabolic Acidosis Risperdal 1 Mg PS ORAL 1 MG QHS ORAL Hospitalization - Neuroleptic Malignant Benztropine SS ORAL 1 MG BID ORAL Initial or Prolonged Syndrome Topamax C Required Rhabdomyolysis Keppra C Intervention to Zoloft C Prevent Permanent Impairment/Damage Date:02/23/05ISR Number: 4594902-3Report Type:Expedited (15-DaCompany Report #2005028730 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Atrioventricular Block Foreign Xanax Tablet Complete Health (Alprazolam) PS ORAL 1.25 MG (0.25 Blood Bicarbonate Professional MG, TID), Decreased ORAL Blood Glucose Increased Risperidone Blood Ph Decreased (Risperidone) SS ORAL 1 MG (DAILY), Blood Pressure Increased ORAL Bundle Branch Block Left Meprobamate Confusional State (Meprobamate) SS ORAL 1 DOSE FORM Depressed Level Of (DAILY), ORAL Consciousness Metoprolol Tartrate Foreign Body Aspiration (Metoprolol Haemoptysis Tartrate) SS ORAL 50 MG (100 Heart Rate Increased MG, DAILY), Interstitial Lung Disease ORAL Oxygen Saturation Capozide (Captopril, Decreased Hydrochlorothiazide) SS ORAL 0.5 DOSE FORM Tachypnoea (DAILY), ORAL Acetylsalicylate Lysine (Acetylsalicylate Lysine) SS ORAL 160 MG (160 MG, DAILY), ORAL Alfuzosin (Alfuzosin) C Macrogol (Macrogol) C 22-Feb-2006 08:20 AM Page: 2451 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/05ISR Number: 4590401-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050203473 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Risperdal PS Initial or Prolonged Drug Interaction Sodium Valproate I Pancytopenia Date:02/24/05ISR Number: 4590402-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050204573 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal PS OROPHARINGEAL Decreased Date:02/24/05ISR Number: 4590403-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041204214 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Increased Risperdal Consta PS INTRAMUSCULAR 30-Nov-04, Hepatitis C second dose Risperdal SS OROPHARINGEAL Mvi C Mvi C Mvi C Mvi C Mvi C Mvi C Mvi C Mvi C Ativan C Date:02/24/05ISR Number: 4590404-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041206672 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Risperdal PS OROPHARINGEAL Hospitalization - Decreased Amantadine Initial or Prolonged Bradycardia Hydrochloride SS UNKNOWN Hypotension Enalapril Maleate SS UNKNOWN Liver Function Test Famotidine C UNKNOWN Abnormal Teprenone C UNKNOWN Pneumonia Aspiration Carbocisteine C UNKNOWN Respiratory Failure Camostat Mesilate C UNKNOWN Tulobuterol C UNKNOWN Clostridium Butyricum C Date:02/24/05ISR Number: 4590405-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050103313 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Risperdal PS OROPHARINGEAL Initial or Prolonged Neuroleptic Malignant Risperdal SS OROPHARINGEAL Syndrome Rhabdomyolysis Water Intoxication 22-Feb-2006 08:20 AM Page: 2452 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/05ISR Number: 4590406-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041200936 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Failure Acute Risperdal PS OROPHARINGEAL Hospitalization - Neuroleptic Malignant Risperdal SS OROPHARINGEAL Initial or Prolonged Syndrome Halomonth SS Olanzapine SS OROPHARINGEAL Olanzapine SS OROPHARINGEAL Cimetidine C Biperiden Hydrochloride C Isoleucine Leucine Valine C Flunitrazepam C Zopiclone C Sennoside C Aspartate Potassium C Date:02/24/05ISR Number: 4590407-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041008024 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Megaloblastic Risperdal PS OROPHARINGEAL Initial or Prolonged Anaemia Vitamin B12 Risperdal SS OROPHARINGEAL Deficiency Phenobarb SS Drug Interaction Nitrazepam C Haemolytic Anaemia Nitrazepam C Sennoside C Chlorpromazine Promethazine C Chlorpromazine Promethazine C Chlorpromazine Promethazine C Flunitrazepam C Quazepam C Date:02/24/05ISR Number: 4590408-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041101099 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Risperdal PS OROPHARINGEAL 6 YR Initial or Prolonged Diabetes Mellitus Risperdal SS OROPHARINGEAL 6 YR Other Non-Insulin-Dependent Benadryl C OROPHARINGEAL Drug Exposure During Lorazepam C OROPHARINGEAL Pregnancy Diovan C OROPHARINGEAL Date:02/24/05ISR Number: 4590409-8Report Type:Periodic Company Report #US-JNJFOC-20040905002 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chronic Obstructive Risperdal PS Pulmonary Disease Respiratory Failure 22-Feb-2006 08:20 AM Page: 2453 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/05ISR Number: 4590599-7Report Type:Expedited (15-DaCompany Report #DE-GLAXOSMITHKLINE-D0045940A Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Tagonis PS Glaxosmithkline UNKNOWN 20MG per day Initial or Prolonged Phosphokinase Increased Risperdal SS UNKNOWN 5MG per day Chills Drug Interaction General Physical Health Deterioration Neuroleptic Malignant Syndrome Pyrexia Somnolence Date:02/24/05ISR Number: 4594913-8Report Type:Expedited (15-DaCompany Report #GXKR2003GB00449 Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Lorazepam (Ngx) Initial or Prolonged Sedation Health (Lorazepam) PS ORAL 1 MG, QHS, Urinary Tract Infection Professional ORAL Other Fluphenazine (Fluphenazine) SS INTRAMUSCULAR 25 MG, INTRAMUSCULAR Risperidone (Risperidone) SS ORAL ORAL Date:02/24/05ISR Number: 4596263-2Report Type:Expedited (15-DaCompany Report #2005AC00283 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Lisinopril PS ORAL 20 MG DAILY Initial or Prolonged Antipsychotic Drug Level Literature PO Above Therapeutic Health Lisinopril SS ORAL 30 MG DAILY Apathy Professional PO Blood Creatinine Other Irbesartan SS 300 MG DAILY Increased Risperidone SS 0.25 MG BID Confusional State Lithium SS 250 MG TID Dehydration Escitalopram SS 10 MG DAILY Drug Interaction Levomepromazine SS 6.25 MG DAILY Drug Level Above Spironolactone SS 50 MG DAILY Therapeutic Furosemide SS 30 MG DAILY Dysarthria Dexetimide C Nervous System Disorder Lormetazepam C Neurotoxicity Metformin C Oliguria Repaglinide C Overdose Somnolence Therapeutic Agent Toxicity Tremor Date:02/25/05ISR Number: 4590811-4Report Type:Expedited (15-DaCompany Report #PHNU2005DE01009 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Drug Interaction Initial or Prolonged Electroencephalogram 22-Feb-2006 08:20 AM Page: 2454 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Abnormal Grand Mal Convulsion Report Source Product Role Manufacturer Route Dose Duration Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL 25 to 250mg/day 15840MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 400 mg, QD 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 575mg/day 1440 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 600mg/day 8640 MIN Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 300 to 575 mg/day 23040MIN Risperdal SS ORAL 2 to 6mg/day 90720MIN Risperdal SS ORAL 5 to 4 mg/day 11520MIN Risperdal SS ORAL 3mg/day Truxal SS UNKNOWN 180 to 260mg/day 31680MIN Truxal SS UNKNOWN 300mg/day 86400MIN Date:02/25/05ISR Number: 4591150-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050204107 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Risperdal PS Initial or Prolonged Convulsion Risperdal Consta SS Other Cough Dyskinesia Formication Insomnia Libido Increased Penile Pain Pruritus Visual Disturbance Date:02/25/05ISR Number: 4591151-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050204325 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Risperdal PS Initial or Prolonged Consciousness Trihexyphenidyl Rhabdomyolysis Hydrochloride SS OROPHARINGEAL Flunitrazepam SS OROPHARINGEAL Chlorpromazine/Prome thazine SS OROPHARINGEAL Chlorpromazine/Prome thazine SS OROPHARINGEAL Chlorpromazine/Prome thazine SS OROPHARINGEAL Aspirin/Dialuminate SS OROPHARINGEAL Aspirin/Dialuminate SS OROPHARINGEAL Aspirin/Dialuminate SS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2455 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Date:02/25/05ISR Number: 4591152-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050103377 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bile Duct Obstruction Risperdal Consta PS INTRAMUSCULAR Cardiac Arrest Risperdal Consta SS INTRAMUSCULAR Liver Function Test Risperdal SS OROPHARINGEAL Abnormal Risperdal SS OROPHARINGEAL Physical Assault Risperdal SS OROPHARINGEAL Psychotic Disorder Risperdal Consta SS INTRAMUSCULAR Date:02/25/05ISR Number: 4591153-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041200531 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Thrombotic Risperdal PS OROPHARINGEAL 23 DAY Thrombocytopenic Purpura Abilify C Seroquel C 100 to 400 mg q hs Depakote C Date:02/25/05ISR Number: 4596083-9Report Type:Expedited (15-DaCompany Report #DSA_25915_2005 Age:31 MON Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Foreign Tavor PS ORAL 1 MG ONCE PO Initial or Prolonged Consumer Risperdal SS SUBLINGUAL 1 MG ONCE SL Other Date:02/28/05ISR Number: 4592321-7Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12785382 Age:41 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Glucose Increased Abilify Tabs 15 Mg PS Otsuka Pharmaceutical Company, Ltd. ORAL 1 MON Risperdal SS Date:02/28/05ISR Number: 4592648-9Report Type:Expedited (15-DaCompany Report #JP-SOLVAY-00304002536 Age:14256 DYGender:Male I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate Aminotransferase Increased 22-Feb-2006 08:20 AM Page: 2456 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Blood Lactate Dehydrogenase Increased C-Reactive Protein Report Source Product Role Manufacturer Route Dose Duration Increased Luvox 25 PS ORAL Daily Dose: Neuroleptic Malignant 75 mg. Syndrome Frequency:Unk White Blood Cell Count nown 7 DAY Increased Luvox 25 SS ORAL Daily Dose: 225 mg. Frequency:Unk nown 319 DAY Anafranil SS ORAL Daily Dose: 105 mg. Frequency:Unk nown 14 DAY Anafranil SS ORAL Daily Dose: 150 mg. Frequency:Unk nown 144 DAY Risperdal SS ORAL Daily Dose: 4 mg. Frequency:Unk nown 158 DAY Wintermin SS ORAL Daily Dose: 12.5 mg. Frequency:Unk nown 359 DAY Myslee C ORAL Daily Dose: 10 mg. Frequency:Unk nown 359 DAY Rohypnol C ORAL Daily Dose: 2 mg. Frequency:Unk nown 359 DAY Akineton C ORAL Daily Dose: 2 mg. Frequency:Unk nown 158 DAY Basen C ORAL Daily Dose: 0.4 mg. Frequency:Unk nown Daonil C ORAL Daily Dose: 5 mg. Frequency:Unk nown Depas C ORAL Daily Dose: 1.5 mg. Frequency:Unk nown 326 DAY Date:02/28/05ISR Number: 4592776-8Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20041204127 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Transient Ischaemic Risperdal PS OROPHARINGEAL Initial or Prolonged Attack Clonidine C 25-25-50 mcg Other 22-Feb-2006 08:20 AM Page: 2457 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592777-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050204325 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Body Temperature Risperdal PS Initial or Prolonged Decreased Trihexyphenidyl Depressed Level Of Hydrochloride SS OROPHARINGEAL Consciousness Flunitrazepam SS OROPHARINGEAL Drug Interaction Chlorpromazine/Prome Rhabdomyolysis thazine SS OROPHARINGEAL Treatment Noncompliance Chlorpromazine/Prome thazine SS OROPHARINGEAL Chlorpromazine/Prome thazine SS OROPHARINGEAL Aspirin/Dialuminate SS OROPHARINGEAL Aspirin/Dialuminate SS OROPHARINGEAL Aspirin/Dialuminate SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Date:02/28/05ISR Number: 4592788-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050204691 Age:71 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal PS OROPHARINGEAL Decreased Date:02/28/05ISR Number: 4592789-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050204692 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS Milnacipran Hydrochloride C OROPHARINGEAL Date:02/28/05ISR Number: 4592790-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050201331 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Resuscitation Risperdal PS OROPHARINGEAL Hospitalization - Sudden Death Perospirone Initial or Prolonged Tachycardia Hydrochloride Ventricular Fibrillation Hydrate C OROPHARINGEAL Lorazepam C Biperiden Hydrochloride C Levomepromazine Maleate C Brotizolam C Flunitrazepam C 22-Feb-2006 08:20 AM Page: 2458 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4592791-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041106871 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Risperdal PS OROPHARINGEAL Haemoglobin Decreased Oren-Gedoku-To C OROPHARINGEAL Red Blood Cell Count Oren-Gedoku-To C OROPHARINGEAL Decreased Oren-Gedoku-To C OROPHARINGEAL White Blood Cell Count Estazolam C OROPHARINGEAL Decreased Flurazepam Hydrochloride C OROPHARINGEAL Promethazine Hydrochloride C OROPHARINGEAL Trihexyphenidyl Hydrochloride C OROPHARINGEAL Ecabet Sodium C OROPHARINGEAL Rilmazafone Hydrochloride C OROPHARINGEAL Date:02/28/05ISR Number: 4597524-3Report Type:Direct Company Report #CTU 241475 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Lethargy Risperidol 1 Mg Qam Intervention to 1.5 Mg Qhs PS ORAL 1 MG QAM 1.5 Prevent Permanent MG QHS PO Impairment/Damage Date:02/28/05ISR Number: 4597530-9Report Type:Direct Company Report #CTU 241514 Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Risperdal PS Psychotic Disorder Treatment Noncompliance Date:02/28/05ISR Number: 4597588-7Report Type:Direct Company Report #CTU 241607 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Risperdal 2 Mg PS ORAL 2 MG TWICE A Hospitalization - Blood Glucose Increased DAY ORAL Initial or Prolonged Cardiac Arrest Remeron 15 Mg SS ORAL 15 MG AT Confusional State BEDTIME ORAL Dehydration Diabetic Hyperosmolar Coma Electrolyte Imbalance Hyperthermia Malignant Lethargy Metabolic Disorder Neuroleptic Malignant Syndrome Photophobia Pneumonia Renal Failure Acute Shock Status Epilepticus 22-Feb-2006 08:20 AM Page: 2459 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4609073-4Report Type:Periodic Company Report #US-JNJFOC-20050106582 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Consumer Risperdal Consta Increased Microspheres Blood Triglycerides (Risperidone) PS INTRAMUSCULAR 25 MG, 1 IN 3 Increased WEEK, Diabetes Mellitus INTRAMUSCULAR Colace (Docusate Sodium) C Vitamin C (Ascorbic Acid) C Propanolol (Propranolol) C Levoxyl (Levothyroxine Sodium) Tablets C Trazodone (Trazodone) Tablets C Date:02/28/05ISR Number: 4609075-8Report Type:Periodic Company Report #US-JNJFOC-20050102767 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Health Risperdal Consta Initial or Prolonged Parkinson'S Disease Professional Microspheres (Risperidone) PS INTRAMUSCULAR 50 MG, 1 IN 2 WEEK, INTRAMUSCULAR Date:02/28/05ISR Number: 4609077-1Report Type:Periodic Company Report #US-JNJFOC-20041204214 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis Health Risperdal Consta Professional Microspheres (Risperidone) PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Tablets SS ORAL 6 MG, IN 1 DAY, ORAL Date:02/28/05ISR Number: 4609080-1Report Type:Periodic Company Report #US-JNJFOC-20041106700 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Risperdal Consta Professional Microspheres (Risperidone) PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRAMUSCULAR Risperidone (Risperidone) SS Benztropine (Benzatropine 22-Feb-2006 08:20 AM Page: 2460 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mesilate) C Metoprolol (Metoprolol) C Hydrochlorothiazide (Hydrochlorothiazide ) C Fluoxetine (Fluoxetine) C Date:02/28/05ISR Number: 4609081-3Report Type:Periodic Company Report #US-JNJFOC-20041104771 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Health Risperdal Consta Neuroleptic Malignant Professional Microspheres Syndrome Company (Risperidone) PS INTRAMUSCULAR 87.5 MG ; 100 Representative MG : 1 IN 1 WEEK, INTRA-MUSCULA R Date:02/28/05ISR Number: 4609083-7Report Type:Periodic Company Report #US-JNJFOC-20041100515 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Risperdal Consta Professional Microspheres Company (Risperidone) PS INTRAMUSCULAR 25 MG, 1 IN 2 Representative WEEK, INTRA-MUSCULA R Date:02/28/05ISR Number: 4609086-2Report Type:Periodic Company Report #US-JNJFOC-20041100520 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Risperdal Consta Professional Microspheres Company (Risperidone) PS INTRAMUSCULAR 50 MG, 1 IN 2 Representative WEEK, INTRA-MUSCULA R Date:02/28/05ISR Number: 4609087-4Report Type:Periodic Company Report #US-JNJFOC-20041100521 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperglycaemia Health Risperdal Consta Professional Microspheres Company (Risperidone) PS INTRAMUSCULAR 37.5 MG, 1 IN Representative 2 WEEK, INTRA-MUSCULA R 22-Feb-2006 08:20 AM Page: 2461 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/28/05ISR Number: 4609088-6Report Type:Periodic Company Report #US-JNJFOC-20041001512 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Risperdal Consta Initial or Prolonged Professional Microspheres (Risperidone) PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRAMUSCULAR Risperdal (Risperidone) Tablets SS 8 MG, 1 IN 1 DAY Geodon (Tablets) Ziprasidone Hydrochloride C Xanax (Alprazolam) C Date:02/28/05ISR Number: 4609089-8Report Type:Periodic Company Report #US-JNJFOC-20040701326 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Health Risperdal Consta Initial or Prolonged Agitation Professional Microspheres Anxiety (Risperidone) PS INTRAMUSCULAR 25 MG, 1 IN 2 Dizziness WEEK, Gynaecomastia INTRA-MUSCULA Hyperhidrosis R Memory Impairment Zoloft (Sertraline Orthostatic Hypotension Hydrochloride) C Paraesthesia Clonopin Sedation (Clonazepam) C Somnolence Adderal (Obetrol) C Tension Headache Weight Increased Date:02/28/05ISR Number: 4609090-4Report Type:Periodic Company Report #US-JNJFOC-20040404440 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Consumer Risperdal Consta Anxiety Microspheres Blood Glucose Increased (Risperidone) PS INTRAMUSCULAR 25 MG, 1 IN 2 Dysarthria WEEK ; 35 Fatigue MG : Food Craving INTRAMUSCULAR Hypertension Risperdal Hypoglycaemia (Risperidone) Injection Site Reaction Solution SS ORAL 5 MG, 1 IN 1 Libido Decreased DAY, ORAL Oedema Depakote (Tablets) Salivary Hypersecretion Valproate Semisodium C Tachycardia Synthroid (Tablets) Visual Acuity Reduced Levothyroxine Sodium C Weight Increased 22-Feb-2006 08:20 AM Page: 2462 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/05ISR Number: 4594117-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050204728 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bundle Branch Block Right Risperdal Consta PS INTRAMUSCULAR Hospitalization - Cardiomegaly Risperdal Consta SS INTRAMUSCULAR Initial or Prolonged Condition Aggravated Haldol SS OROPHARINGEAL Drug Ineffective Fluanxol SS Fluanxol Sudden Death depot 10% Risperdal Consta SS INTRAMUSCULAR Risperdal C OROPHARINGEAL 4-5 mg Risperdal C OROPHARINGEAL 2-4 mg Levomepromazin C Akineton C Tavor C 0.5-1 mg as needed Concor C Vesdil C Neurotrat C Neurotrat C Neurotrat C Neurotrat C Date:03/01/05ISR Number: 4594118-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050205999 Age:54 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Risperdal PS OROPHARINGEAL Sinus Arrest Date:03/01/05ISR Number: 4594119-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050202276 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Injection Site Necrosis Risperdal Consta PS INTRAMUSCULAR < 2 years Injection Site Ulcer Risperdal Consta SS INTRAMUSCULAR Date:03/02/05ISR Number: 4595961-4Report Type:Expedited (15-DaCompany Report #CN-JNJFOC-20050204685 Age:22 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cholelithiasis Risperdal PS Hepatic Lesion Risperdal SS Liver Function Test Clonazepam C Abnormal Tiopronin C OROPHARINGEAL Pyrexia Antan C OROPHARINGEAL Red Blood Cells Urine Vitamin C C Positive Xiao Chai Hu C White Blood Cells Urine Haloperidol C Positive Cefradine C OROPHARINGEAL Tropine C INTRAMUSCULAR Date:03/02/05ISR Number: 4595962-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050204763 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Risperdal PS Prolonged Eunerpan SS 22-Feb-2006 08:20 AM Page: 2463 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Arelix SS Diazepam C Vitamin B12 C Dreisafer C Dreisafer C Date:03/02/05ISR Number: 4595963-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050204924 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Risperdal PS OROPHARINGEAL Initial or Prolonged Corrected Interval Prolonged Date:03/02/05ISR Number: 4595964-XReport Type:Expedited (15-DaCompany Report #NZ-JNJFOC-20050205094 Age:17 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Risperdal PS OROPHARINGEAL Decreased Lorazepam C Date:03/02/05ISR Number: 4595965-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050206295 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cognitive Disorder Risperdal PS OROPHARINGEAL 23 DAY Initial or Prolonged Rhabdomyolysis Paxil Cr C OROPHARINGEAL 12 MON Other Sular C OROPHARINGEAL Prinizide C OROPHARINGEAL Prinizide C OROPHARINGEAL Date:03/02/05ISR Number: 4596483-7Report Type:Expedited (15-DaCompany Report #DE-SANOFI-SYNTHELABO-A04200500158 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aphasia Stilnox PS ORAL 10 mg Initial or Prolonged Blood Creatine Remergil I ORAL 15 mg 1 DAY Phosphokinase Increased Remergil I ORAL 30 mg 12 DAY Confusional State Remergil I ORAL 45 mg 34 DAY Disorientation Risperdal I ORAL 1 mg 6 DAY Hyponatraemia Timonil I ORAL 1000 mg Nausea Thinking Abnormal Date:03/02/05ISR Number: 4598187-3Report Type:Expedited (15-DaCompany Report #2005GB00325 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Foreign Quetiapine PS ORAL 150 MG PO Initial or Prolonged Tremor Health Risperidone SS ORAL 1 MG PO Disability Professional Lithium C Other Cipramil C Zopiclone C 22-Feb-2006 08:20 AM Page: 2464 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/05ISR Number: 4597576-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050204934 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arteriosclerosis Risperdal PS 1-3mg Bronchiectasis Risperdal SS Cardio-Respiratory Arrest Truxal SS Cardiomegaly Truxal SS Circulatory Collapse Tavor SS Cyanosis Eunerpan SS Drug Interaction Eunerpan SS Dyspnoea Eunerpan SS Hepatic Congestion Timonil SS Loss Of Consciousness Delix 2.5 Plus C Pulmonary Fibrosis Delix 2.5 Plus C Right Ventricular Failure Ass C Spleen Congestion Ismo C Syncope Dytide H C Dytide H C 1 tbl. Date:03/03/05ISR Number: 4597578-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050107016 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal PS UNKNOWN Decreased Ritalin SS Date:03/03/05ISR Number: 4597579-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050204725 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drooling Risperdal PS OROPHARINGEAL Laryngeal Disorder Risperdal SS OROPHARINGEAL Malnutrition Depamide C Shock Scopolamine C Weight Decreased Date:03/03/05ISR Number: 4597580-2Report Type:Periodic Company Report #BE-JNJFOC-20040901428 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Insipidus Risperdal PS OROPHARINGEAL Polydipsia Polyuria Date:03/03/05ISR Number: 4597581-4Report Type:Periodic Company Report #DE-JNJFOC-20050204728 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Risperdal Consta PS INTRAMUSCULAR Hospitalization - Condition Aggravated Risperdal Consta SS INTRAMUSCULAR Initial or Prolonged Drug Ineffective Haldol SS OROPHARINGEAL Sudden Death Fluanxol SS Fluanxol depot 10% Risperdal Consta SS INTRAMUSCULAR Risperdal C OROPHARINGEAL 4-5 mg Risperdal C OROPHARINGEAL 2-4 mg Levomepromazin C 22-Feb-2006 08:20 AM Page: 2465 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Akineton C Tavor C 0.5-1 mg as needed Concor C Vesdil C Neurotrat C Neurotrat C Neurotrat C Neurotrat C Date:03/04/05ISR Number: 4598399-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050205103 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal PS Initial or Prolonged Leukopenia Risperdal SS Thrombocytopenia Dytide I Dytide I 1/2 Tbl Bayotensin I 1/2 Tbl Date:03/04/05ISR Number: 4598400-2Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20050203227 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Swelling Risperdal Consta PS Hyperprolactinaemia Date:03/04/05ISR Number: 4598401-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050205818 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Injection Site Infection Risperdal Consta PS INTRAMUSCULAR Injection Site Swelling Diazepam C OROPHARINGEAL Injection Site Ulcer Quetiapine C OROPHARINGEAL Date:03/04/05ISR Number: 4598402-6Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20050206201 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Risperdal PS Methylphenidate C Date:03/04/05ISR Number: 4598403-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050206369 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amputation Of Penis Risperdal PS Priapism Date:03/04/05ISR Number: 4598404-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050206554 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal Consta PS OTHER 22-Feb-2006 08:20 AM Page: 2466 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/04/05ISR Number: 4598405-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050206578 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Risperdal PS OROPHARINGEAL Date:03/04/05ISR Number: 4598406-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050206579 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Exposure During Risperdal PS OROPHARINGEAL Pregnancy Pulmonary Embolism Date:03/04/05ISR Number: 4598407-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050300042 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperdal PS OROPHARINGEAL Insulin-Dependent Klonidine C OROPHARINGEAL Date:03/04/05ISR Number: 4598408-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050202276 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Injection Site Necrosis Risperdal Consta PS INTRAMUSCULAR < 2 years Injection Site Ulcer Risperdal Consta SS INTRAMUSCULAR Pharmaceutical Product Complaint Date:03/04/05ISR Number: 4598409-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050105123 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Risperdal Consta PS INTRAMUSCULAR Myocardial Ischaemia Diclofenac C Date:03/04/05ISR Number: 4598410-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050204325 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Risperdal PS Initial or Prolonged Consciousness Risperdal SS Rhabdomyolysis Trihexyphenidyl Hydrochloride SS OROPHARINGEAL Flunitrazepam SS OROPHARINGEAL Flunitrazepam SS OROPHARINGEAL Chlorpromazine/Prome thazine SS OROPHARINGEAL Chlorpromazine/Prome thazine SS OROPHARINGEAL Chlorpromazine/Prome thazine SS OROPHARINGEAL Aspirin/Dialuminate SS OROPHARINGEAL Aspirin/Dialuminate SS OROPHARINGEAL Aspirin/Dialuminate SS OROPHARINGEAL Pabron SS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2467 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Date:03/04/05ISR Number: 4599839-1Report Type:Direct Company Report #CTU 242054 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Syncope Risperidone (Risperdal) PS ORAL 0.5 MG/2 TABS PO/D Down'S Syndrome C Date:03/04/05ISR Number: 4601322-1Report Type:Expedited (15-DaCompany Report #2002133124US Age:33 YR Gender:Unknown I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Literature Diphenhydramine Health (Diphenhydramine) PS ORAL ORAL Professional Risperidone (Risperidone) SS ORAL UNSPECIFIED AMT, ORAL Bupropion (Bupropion) SS ORAL UNSPECIFIED AMT, ORAL Date:03/07/05ISR Number: 4599548-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050205838 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Jaundice Cholestatic Risperdal Consta PS INTRAMUSCULAR Pancreatic Carcinoma Risperdal Consta SS INTRAMUSCULAR Weight Decreased Date:03/07/05ISR Number: 4599549-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050205847 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypothermia Risperdal PS OROPHARINGEAL Leukopenia Risperdal SS OROPHARINGEAL Tercian C Stablon C Hept-A-Myl C Date:03/07/05ISR Number: 4599550-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050204691 Age:71 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal PS OROPHARINGEAL Decreased 22-Feb-2006 08:20 AM Page: 2468 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/05ISR Number: 4599833-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050206378 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Risperdal Consta PS INTRAMUSCULAR Swelling Face Date:03/07/05ISR Number: 4599834-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050206429 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Risperdal Consta PS INTRAMUSCULAR therapy Cardiac Disorder dates: since Hypertension 1 year Tremor Risperdal SS OROPHARINGEAL 7.5 mg up to 12 mg therapy dates: since one year Date:03/07/05ISR Number: 4599835-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050300092 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Risperdal Consta PS INTRAMUSCULAR Swelling Face Date:03/07/05ISR Number: 4602590-2Report Type:Expedited (15-DaCompany Report #2005036735 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zoloft (Sertraline) PS ORAL 200 MG (100 Initial or Prolonged Anorexia MG, 1 D), Other Anxiety ORAL Blood Potassium Decreased Risperidone Drug Ineffective (Risperisone) SS ORAL ORAL Hyperhidrosis Lansoprazole Incoherent (Lansoprazole) C Inguinal Hernia Repair Tamsulosin Nausea Hydrochloride Oesophageal Disorder (Tamsulosin Tremor Hydrochloride) C Weight Decreased Levothyroxine Sodium (Levothyroxine Sodium) C Loratadine (Loratadine) C Tramadol (Tramadol) C Lorazepam (Lorazepam) C Date:03/07/05ISR Number: 4603002-5Report Type:Expedited (15-DaCompany Report #2005035311 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Deep Vein Thrombosis Foreign Zoloft (Sertraline) PS ORAL 50 MG, ORAL Initial or Prolonged Pulmonary Embolism Health Lorazepam Other Stress Professional (Lorazepam) SS 2 MG 22-Feb-2006 08:20 AM Page: 2469 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperidone (Risperidone) SS 1.5 MG Ramipril (Ramipril) C Zopiclone (Zopiclone) C Paracetamol (Paracetamol) C Date:03/08/05ISR Number: 4603563-6Report Type:Expedited (15-DaCompany Report #DEWYE477604MAR05 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Study Trevilor Initial or Prolonged Increased (Venlafaxine Aspartate Hydrochloride, Aminotransferase Tablet, 0) PS ORAL 75 MG PER DAY Increased ORAL; SEE Drug Interaction IMAGE 10 DAY Risperdal (Risperidone, , 0) SS ORAL 1 MG PER DAY ORAL; SEE IMAGE 14 DAY Tavor (Lorazepam) C Date:03/09/05ISR Number: 4602454-4Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20050205989 Age:89 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Risperdal PS OROPHARINGEAL Hospitalization - Cerebral Infarction Aricept C Initial or Prolonged Myocardial Infarction Panodil C Betolvex C Plendil C Oxascand C Trombyl C Date:03/09/05ISR Number: 4602455-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050201870 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Health Risperdal PS OROPHARINGEAL Initial or Prolonged Aggression Professional Risperdal Consta SS OTHER Agitation Cardiac Failure Congestive Irritability Paranoia Polydipsia Urinary Incontinence Date:03/09/05ISR Number: 4602456-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050204694 Age: Gender:Male I/FU:I Outcome PT Death Bradykinesia Hypothermia Liver Disorder 22-Feb-2006 08:20 AM Page: 2470 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Malnutrition Obstructive Airways Disorder Report Source Product Role Manufacturer Route Dose Duration Urinary Tract Infection Risperdal PS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Nitrazepam C OROPHARINGEAL Brotizolam C OROPHARINGEAL Magnesium Oxide C OROPHARINGEAL Sennoside C Mosapride Citrate C Pantethine C Date:03/09/05ISR Number: 4602764-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050300030 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cyanosis Risperdal PS OROPHARINGEAL taken at night Date:03/09/05ISR Number: 4602765-2Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20040905836 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychomotor Skills Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Impaired Salivary Hypersecretion Somnolence Tremor Date:03/09/05ISR Number: 4604029-XReport Type:Direct Company Report #CTU 242395 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Activities Of Daily Risperdal Consta Living Impaired Injection PS INTRAMUSCULAR THOUGHT TO BE Depressed Mood 25 MG, IM Eye Disorder EVERY 2 WEEKS 4 MON Fear Feeling Abnormal Feeling Of Despair Hearing Impaired Libido Decreased Marital Problem Reflexes Abnormal Thinking Abnormal Visual Disturbance Date:03/09/05ISR Number: 4607743-5Report Type:Expedited (15-DaCompany Report #DSA_25973_2005 Age: Gender:Female I/FU:I Outcome PT Death Cardiac Failure Acute Circulatory Collapse Cyanosis Loss Of Consciousness 22-Feb-2006 08:20 AM Page: 2471 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Arrest Report Source Product Role Manufacturer Route Dose Duration Foreign Tavor PS ORAL 2 MG Q DAY PO Health Eunerpan SS 100 MG Q DAY Professional Eunerpan SS 250 MG Q DAY Other Eunerpan SS 125 MG Q DAY Risperdal SS 4 MG Q DAY Risperdal SS DF Q DAY Timonil SS 450 MG Q DAY Truxal SS 400 MG Q DAY Truxal SS 200 MG Q DAY Delix C Acetylsalicylic Acid C Isosorbide Mononitrate C Dytide H C Date:03/10/05ISR Number: 4603695-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050100373 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal PS UNKNOWN Initial or Prolonged Hallucination, Auditory Risperdal SS UNKNOWN Herpes Zoster Bifeprunox SS UNKNOWN Bifeprunox SS UNKNOWN Placebo SS Placebo SS Tarivid C UNKNOWN Femodene C UNKNOWN Femodene C UNKNOWN Daflon C UNKNOWN Nozid C UNKNOWN Corsodyl C UNKNOWN Akineton C UNKNOWN as needed with a max dose of twice daily Temesta C UNKNOWN as needed with a max dosage of 3mg /day. Date:03/10/05ISR Number: 4603698-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050300694 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Eye Pain Risperdal PS OROPHARINGEAL Initial or Prolonged Hallucination Risperdal SS OROPHARINGEAL Hospitalisation Risperdal Consta SS INTRAMUSCULAR Panic Attack Lorazepam C OROPHARINGEAL Date:03/10/05ISR Number: 4604309-8Report Type:Expedited (15-DaCompany Report #US-ABBOTT-04P-163-0279316-00 Age:19 YR Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Valproic Acid (Long Overdose Acting) PS ORAL 22-Feb-2006 08:20 AM Page: 2472 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperidone SS ORAL Venlafaxine SS ORAL Date:03/11/05ISR Number: 4605012-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050300050 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Unevaluable Event Risperdal PS Sodium Valproate C UNKNOWN Clozaril C UNKNOWN Date:03/11/05ISR Number: 4605013-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050300056 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Risperidone PS OROPHARINGEAL Initial or Prolonged Injury Fluoxetin SS Date:03/11/05ISR Number: 4605014-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050300079 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL since several Pulmonary Embolism months Pyrexia Risperdal SS OROPHARINGEAL Abilify C Rivotril C Tercian C Date:03/11/05ISR Number: 4605015-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050301085 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Risperdal PS OROPHARINGEAL Initial or Prolonged Dizziness Restoril C OROPHARINGEAL Drooling Benztropine C OROPHARINGEAL Joint Dislocation Zyprexa C OROPHARINGEAL Musculoskeletal Stiffness Clonazepam C OROPHARINGEAL Salivary Hypersecretion Abilify C Somnolence Nifedipine C OROPHARINGEAL Tremor Motrin C OROPHARINGEAL Urinary Incontinence Prevacid C OROPHARINGEAL Weight Decreased Lipitor C OROPHARINGEAL Metroprolol C OROPHARINGEAL Thiothixene C OROPHARINGEAL Date:03/11/05ISR Number: 4605016-8Report Type:Periodic Company Report #DE-JNJFOC-20050206429 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Risperdal Consta PS INTRAMUSCULAR therapy Hypertension dates: since Tremor 1 year Risperdal SS OROPHARINGEAL 7.5 mg up to 12 mg therapy 22-Feb-2006 08:20 AM Page: 2473 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report dates: since one year Date:03/11/05ISR Number: 4605017-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050107016 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Penile Swelling Risperdal PS OROPHARINGEAL Swelling Face Risperdal SS OROPHARINGEAL Urticaria White Blood Cell Count Decreased Date:03/11/05ISR Number: 4605018-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050205090 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Herpes Zoster Risperdal PS OROPHARINGEAL Initial or Prolonged Inappropriate Ciclosporin C Other Antidiuretic Hormone Nilvadipine C OROPHARINGEAL Secretion Metoprolol Tartrate C OROPHARINGEAL Methylprednisolone C OROPHARINGEAL Bromazepam C OROPHARINGEAL Azathioprine C Date:03/11/05ISR Number: 4605858-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050103313 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Risperdal PS OROPHARINGEAL Initial or Prolonged Increased Risperdal SS OROPHARINGEAL Aspartate Biperiden Aminotransferase Hydrochloride C OROPHARINGEAL Increased Blood Sodium Decreased Extrapyramidal Disorder Grand Mal Convulsion Loss Of Consciousness Neuroleptic Malignant Syndrome Polydipsia Rhabdomyolysis Vomiting Water Intoxication Date:03/11/05ISR Number: 4608376-7Report Type:Direct Company Report #CTU 242957 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Risperidone PS ORAL 1 MG PO Q AM Muscle Rigidity ; 2 MG PO Q HS Risperidone SS 22-Feb-2006 08:20 AM Page: 2474 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/14/05ISR Number: 4606958-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050102796 Age:10 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Risperdal PS OROPHARINGEAL Initial or Prolonged Incontinence Risperdal SS OROPHARINGEAL Polydipsia Risperdal SS OROPHARINGEAL Date:03/14/05ISR Number: 4606959-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050300708 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Risperdal PS OROPHARINGEAL Initial or Prolonged Increased Taxilan SS Aspartate Hypnorex C Aminotransferase Mescorit C Increased Amaryl C Blood Alkaline Noctamid C Phosphatase Increased Diazepam C Blood Bilirubin Increased Gamma-Glutamyltransferase Increased Liver Disorder Date:03/14/05ISR Number: 4606960-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050300725 Age:52 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Risperdal PS OROPHARINGEAL 8 DAY Initial or Prolonged Anxiety Stangyl SS Disturbance In Attention Insomnia Irritability Restlessness Date:03/14/05ISR Number: 4606961-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050301476 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:03/14/05ISR Number: 4606962-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041007637 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS OROPHARINGEAL 1.5 MG bd per source documents 21 DAY Risperdal SS OROPHARINGEAL 100 MG per source documents 21 DAY Clozapine SS OROPHARINGEAL Ranitidine SS Gabapentin SS OROPHARINGEAL Lamotrigine SS OROPHARINGEAL 25-50 MG 22-Feb-2006 08:20 AM Page: 2475 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/14/05ISR Number: 4606963-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041203062 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Pain Upper Risperdal PS OROPHARINGEAL Abnormal Behaviour Risperdal SS OROPHARINGEAL Blood Glucose Increased Lithium Carbonate C OROPHARINGEAL Blood Prolactin Increased Topamax C OROPHARINGEAL Depression Tegretol C OROPHARINGEAL Diarrhoea Fatigue Glossodynia Irritable Bowel Syndrome Mood Altered Pituitary Tumour Pollakiuria Tardive Dyskinesia Thirst Date:03/14/05ISR Number: 4607617-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050300605 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cyanosis Risperdal PS UNKNOWN Extrapyramidal Disorder Haldol SS INTRAVENOUS Gaze Palsy Laryngospasm Oropharyngeal Spasm Date:03/14/05ISR Number: 4609157-0Report Type:Expedited (15-DaCompany Report #DSA_25987_2005 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Tavor PS 2 MG Q DAY Initial or Prolonged Pulmonary Embolism Health Risperdal SS 1.5 MG Q DAY Thrombosis Professional Zoloft SS 50 MG Q DAY Other Delix C Ximovan C Ben-U-Ron C Date:03/14/05ISR Number: 4609771-2Report Type:Direct Company Report #CTU 243136 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arthralgia Zyprexa PS Initial or Prolonged Hypoaesthesia Risperdal , 0.50 Disability Insomnia Mg/Ml SS EVERY TWO WKS Other Libido Disorder BY INJ Nail Disorder Weight Increased Date:03/14/05ISR Number: 4609872-9Report Type:Expedited (15-DaCompany Report #2005-126032-NL Age:22 YR Gender:Male I/FU:I Outcome PT Hospitalization - Activated Protein C Initial or Prolonged Resistance Arrhythmia 22-Feb-2006 08:20 AM Page: 2476 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Deep Vein Thrombosis Erythema Hyperthermia Report Source Product Role Manufacturer Route Dose Duration Swelling Mirtazapine PS DF 2 WK Risperidone SS MG; 52 DAY Chlorprothixene Hydrochloride SS MG; Biperiden C Magnesium Verla Dragees C Date:03/15/05ISR Number: 4608497-9Report Type:Expedited (15-DaCompany Report #2005004461 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenopia Quilonum Retard PS Glaxosmithkline ORAL 6TAB Single Initial or Prolonged Dizziness dose 1 DAY Intentional Overdose Risperdal SS ORAL 20TAB Single Multiple Drug Overdose dose Intentional Suicide Attempt Date:03/15/05ISR Number: 4608598-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050301632 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Risperdal PS UNKNOWN Initial or Prolonged Other Date:03/15/05ISR Number: 4608599-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050302177 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Risperdal PS OROPHARINGEAL Date:03/15/05ISR Number: 4608600-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041207554 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adrenal Adenoma Risperdal PS OROPHARINGEAL Initial or Prolonged Beta 2 Microglobulin Alprazolam C OROPHARINGEAL Increased Flunitrazepam C Oedema Furosemide C Pituitary-Dependent Cushing'S Syndrome Date:03/15/05ISR Number: 4608601-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050204325 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressed Level Of Risperdal PS Initial or Prolonged Consciousness Risperdal SS Rhabdomyolysis Trihexyphenidyl Hydrochloride SS OROPHARINGEAL Flunitrazepam SS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2477 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Flunitrazepam SS OROPHARINGEAL Chlorpromazine/Prome thazine SS OROPHARINGEAL Chlorpromazine/Prome thazine SS OROPHARINGEAL Chlorpromazine/Prome thazine SS OROPHARINGEAL Aspirin/Dialuminate SS OROPHARINGEAL Aspirin/Dialuminate SS OROPHARINGEAL Aspirin/Dialuminate SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Pabron SS OROPHARINGEAL Date:03/15/05ISR Number: 4608653-XReport Type:Expedited (15-DaCompany Report #NL-JNJFOC-20050301128 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Therapeutic Agent Other Toxicity Date:03/15/05ISR Number: 4608733-9Report Type:Expedited (15-DaCompany Report #PHNU2005DE00955 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Lioresal PS Novartis Sector: Depressed Level Of Pharma ORAL 10 mg, BID Consciousness Risperdal SS ORAL 1 mg, QD 5760 MIN Risperdal SS ORAL Durogesic C SUBCUTANEOUS UNK, UNK Zolpidem C ORAL Ramipril C ORAL Date:03/15/05ISR Number: 4610081-8Report Type:Expedited (15-DaCompany Report #GXKR2005US00691 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Literature Divalproex Sodium Initial or Prolonged Insulin-Dependent (Ngx) (Divalproex) PS Disability Lethargy Risperidone (Ngx) Weight Increased (Risperidone) SS Clonazepam (Ngx) (Clonazepam) SS Date:03/15/05ISR Number: 4614231-9Report Type:Expedited (15-DaCompany Report #20050200046 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Hospitalization - Drug Interaction Foreign Initial or Prolonged Pulmonary Embolism Health Thrombosis Professional 22-Feb-2006 08:20 AM Page: 2478 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Product Role Manufacturer Route Dose Duration Ativan (Lorazepam) Baxter PS Baxter 2 MG QD Risperdal (Risperidone) SS 1.5 MG QD Zoloft (Sertraline Hydrochloride) SS 50 MG QD Delix (Ramipril) C Ximovan (Zopiclone) C Ben-U-Ron (Paracetamol) C Date:03/16/05ISR Number: 4610088-0Report Type:Expedited (15-DaCompany Report #AU-SANOFI-SYNTHELABO-A01200501373 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Toxicity Stilnox PS ORAL UNK Hepatic Steatosis Zyprexa SS ORAL 10 mg 17 DAY Risperidone SS INTRAMUSCULAR UNK 54 DAY Mirtazapine SS ORAL UNK Date:03/16/05ISR Number: 4610130-7Report Type:Expedited (15-DaCompany Report #FI-JNJFOC-20050300646 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Risperdal PS OROPHARINGEAL Initial or Prolonged Electrocardiogram Pq Kepra C OROPHARINGEAL Interval Prolonged Lamictal C OROPHARINGEAL Electrocardiogram Qt Absenor C OROPHARINGEAL Prolonged Lanzo C OROPHARINGEAL Pro-Epanutin C INTRAVENOUS Date:03/16/05ISR Number: 4610131-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050301420 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Risperdal PS OROPHARINGEAL Sleep Apnoea Syndrome Delix C OROPHARINGEAL Sudden Death Acc 200 C OROPHARINGEAL Date:03/16/05ISR Number: 4610132-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041204782 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Risperdal PS OROPHARINGEAL 892 DAY Initial or Prolonged Hepatitis Acute Pimozide SS 892 DAY Other Biperiden Hydrochloride SS OROPHARINGEAL 892 DAY Clarithromycin C Chlorpheniramine Maleate C Bromhexine Hydrochloride C Proceterol Hydrochloride C 22-Feb-2006 08:20 AM Page: 2479 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/16/05ISR Number: 4610133-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050201331 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Cardiac Death Risperdal PS OROPHARINGEAL 5 DAY Hospitalization - Ventricular Fibrillation Perospirone Initial or Prolonged Hydrochloride Hydrate C OROPHARINGEAL 1327 DAY Lorazepam C Biperiden Hydrochloride C Levomepromazine Maleate C Brotizolam C Flunitrazepam C Date:03/16/05ISR Number: 4610134-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041006497 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Risperdal PS OROPHARINGEAL Infarction Risperdal SS OROPHARINGEAL Angina Pectoris Risperdal SS OROPHARINGEAL Extrapyramidal Disorder Risperdal SS OROPHARINGEAL Nitroglycerin C Diazepam C Diazepam C Biperiden Hydrochloride C Date:03/16/05ISR Number: 4613299-3Report Type:Expedited (15-DaCompany Report #2005PK00382 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Seroquel PS ORAL 400 MG DAILY Initial or Prolonged Oedema Health PO Oedema Peripheral Professional Seroquel SS ORAL 500 MG DAILY Other PO Taxilan SS ORAL 150 MG DAILY PO Taxilan SS ORAL 100 MG DAILY PO Orfiril SS 10000 MG DAILY Saroten Retard SS ORAL 75 MG DAILY PO Truxal SS ORAL 250 MG DAILY PO Risperal SS ORAL 1 MG DAILY PO Risperal SS ORAL 2MG DAILY PO Risperal SS ORAL 3 MG DAILY PO Date:03/16/05ISR Number: 4613343-3Report Type:Expedited (15-DaCompany Report #2005042029 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperchlorhydria Foreign Gabapentin Mood Altered Health (Gabapentin) PS ORAL 100 MG (100 Neutropenia Professional MG, 1 IN 1 22-Feb-2006 08:20 AM Page: 2480 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report D),ORAL Clozapine (Clozapine) SS ORAL ORAL Ranitidine Hydrochloride (Ranitidine Hydrochloride) SS 150 MG (150 MG, 1 IN 1 D) Risperidone (Risperidone) SS ORAL 3 MG (1.5 MG, 2 IN 1 D),ORAL Lamotrigine (Lamotrigine) SS ORAL ORAL Date:03/17/05ISR Number: 4611156-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050301645 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Risperdal Consta PS INTRAMUSCULAR Cardiac Arrest Risperdal C OROPHARINGEAL Coma Leponex I OROPHARINGEAL Drug Interaction Hypoxic Encephalopathy Pulmonary Embolism Date:03/17/05ISR Number: 4611157-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041200939 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Catatonia Risperdal PS OROPHARINGEAL Chest Pain Risperdal SS OROPHARINGEAL Cogwheel Rigidity Flunitrazepam C OROPHARINGEAL Drug Interaction Chinese Medicines C Hallucination Sulpiride C OROPHARINGEAL Incoherent Atorvastatin Calcium I Pollakiuria Rhabdomyolysis Syncope Tremor Date:03/17/05ISR Number: 4613446-3Report Type:Direct Company Report #CTU 243502 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Risperidol 1 Mg PS 1 MG PER PEG Initial or Prolonged Prolonged TUBE DAILY Ventricular Tachycardia Trazodone 50 Mg SS 50 MG PER PEG TUBE QHS Fluconazole 200 Mg -1100 Ml D5w SS INTRAVENOUS 200 MG IVPB Q24 H Clotrimazole 10 Mg SS ORAL 10 MG PO TID Dopamine 400 Mg/250 Ml D5w SS TITRATED TO BLOOD PRESSURE Metoclopramide 5 Mg SS 2.5 MG PER PEG TUBE TID 22-Feb-2006 08:20 AM Page: 2481 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ondansetron 2 Mg/Ml C INTRAVENOUS 2 MG IV Q 6H PRN N/V Ns Flush C Cactinex C Nystatin Topical Powder C Vit C C Baclofen C Remeron C Nystatin Cream C Phenergan C Albuterol Nebulized C Atrovent C Tpn C Ativan C Vancomycin C Amiodarone C Fentanyl Pca C Primaxin C Depacon C Lipids C Cetacaine C Morphine C Tylenol C Lactated Ringers C Date:03/17/05ISR Number: 4615391-6Report Type:Expedited (15-DaCompany Report #DSA_26039_2005 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Foreign Tavor PS ORAL 2 MG PO Initial or Prolonged Aminotransferase Health Perazine SS ORAL 750 MG PO Increased Professional Risperdal SS ORAL 30 MG PO Blood Glucose Increased Other Blood Potassium Decreased Diarrhoea Dizziness Dry Mouth Eye Movement Disorder Multiple Drug Overdose Intentional Musculoskeletal Stiffness Nausea Tachycardia Transaminases Increased Date:03/17/05ISR Number: 4619597-1Report Type:Direct Company Report #CTU 243478 Age:58 YR Gender:Male I/FU:I Outcome PT Death Asthenia Life-Threatening Atrial Fibrillation Cardio-Respiratory Arrest Cerebral Atrophy Cerebrovascular Accident Condition Aggravated Facial Palsy Gastrointestinal Haemorrhage 22-Feb-2006 08:20 AM Page: 2482 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lethargy Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Risperdal PS ORAL 1 MG PO Q AM AND HS (X5) Haloperidol SS ORAL 2 MG PO Q6 H RN (X1) Carbidopa/Levodepa 25/250 Mg Po, 8 Tabls Daily SS ORAL 25/250 PO, 8 TABS DAILY Ativan C Captopril C K-Dur C Zocor C Wellbutrin Sr C Digoxin C Coumadin C Humulin 70/30 C Metoprolol C Plavix C Lovenox C Demadex C Diltiazem Cd C Lexapro C Date:03/18/05ISR Number: 4612534-5Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12899621 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Abilify Tabs 15 Mg PS Otsuka Other Phosphokinase Increased Pharmaceutical Cardiac Arrest Company, Ltd. ORAL Electrocardiogram St Lepticur SS Segment Elevation Rivotril SS Fall Tercian SS ORAL Hyperkalaemia Lipanthyl SS ORAL Malaise Risperdal SS Psychomotor Hyperactivity Respiratory Arrest Date:03/18/05ISR Number: 4612842-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050301984 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Risperdal PS OROPHARINGEAL Hemianopia Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Urbanyl C Date:03/18/05ISR Number: 4612843-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050302346 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Risperdal PS OROPHARINGEAL Initial or Prolonged Depression Risperdal SS OROPHARINGEAL Suicidal Ideation Risperdal SS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2483 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/18/05ISR Number: 4612844-1Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20050203212 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Breast Neoplasm Risperdal PS OROPHARINGEAL Hyperprolactinaemia Pain Date:03/18/05ISR Number: 4612845-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050202276 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Injection Site Ulcer Risperdal Consta PS INTRAMUSCULAR < 2 years Risperdal Consta SS INTRAMUSCULAR Date:03/18/05ISR Number: 4616433-4Report Type:Expedited (15-DaCompany Report #L04-USA-07403-28 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abnormal Behaviour Literature Celexa (Citalopram Hospitalization - Cardiac Arrest Health Hydrobromide) PS Initial or Prolonged Completed Suicide Professional Risperidone Confusional State (Risperidone) SS Convulsion Methylphenidate SS Hypotension Rofecoxib SS Multiple Drug Overdose Hydrochlorothiazide SS Intentional Aspirin Respiratory Arrest (Acetylsalicylic Stupor Acid) SS Ventricular Tachycardia Date:03/18/05ISR Number: 4617137-4Report Type:Expedited (15-DaCompany Report #L04-USA-07403-25 Age:31 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Citalopram PS Multiple Drug Overdose Health Alprazolam SS Intentional Professional Risperidone (Risperidone) SS Date:03/21/05ISR Number: 4613583-3Report Type:Expedited (15-DaCompany Report #PL-JNJFOC-20050302003 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Alanine Aminotransferase Risperdal PS Hospitalization - Increased Ketoprofen C Initial or Prolonged Aspartate Diazepam C Aminotransferase Increased Blood Creatinine Increased Blood Urea Increased Fibrin D Dimer Increased General Physical Health Deterioration Haematuria Pyrexia Troponin T Increased 22-Feb-2006 08:20 AM Page: 2484 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/05ISR Number: 4613584-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050302736 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal Consta PS INTRAMUSCULAR Rash Date:03/21/05ISR Number: 4613585-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041103377 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Crohn'S Disease Risperdal PS OROPHARINGEAL Hospitalization - Myocardial Infarction Glucotrol C Initial or Prolonged Actose C Lipitor C Asacol C Pepcid C Flexeril C Date:03/21/05ISR Number: 4613587-0Report Type:Expedited (15-DaCompany Report #NZ-JNJFOC-20050205094 Age:17 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Risperdal PS OROPHARINGEAL Decreased Risperdal SS OROPHARINGEAL Weight Increased Lorazepam C Date:03/21/05ISR Number: 4613588-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050201739 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akathisia Risperdal PS OROPHARINGEAL Initial or Prolonged Ileus Risperdal SS OROPHARINGEAL Schizophrenia Chlorpromazine Hydrochloride SS OROPHARINGEAL Chlorpromazine Hydrochloride SS OROPHARINGEAL Biperiden Hydrochloride SS Dinoprostone Betadex C Date:03/21/05ISR Number: 4613589-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041206038 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Drug Exposure During Risperdal PS OROPHARINGEAL Other Pregnancy Risperdal SS OROPHARINGEAL Foetal Growth Retardation Risperdal SS OROPHARINGEAL Neonatal Disorder Risperdal SS OROPHARINGEAL Platelet Count Decreased Haldol C UNKNOWN Small For Dates Baby Zopliclone C OROPHARINGEAL Nitrazepam C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2485 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/05ISR Number: 4613590-0Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20050202688 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Potassium Decreased Risperdal PS OROPHARINGEAL Neutrophil Count Risperdal SS OROPHARINGEAL Decreased Platelet Count Decreased Date:03/21/05ISR Number: 4615876-2Report Type:Expedited (15-DaCompany Report #GXKR2005DE00760 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Fluoxetine (Ngx) Nuclear Magnetic Literature (Fluoxetine) PS SEE IMAGE Resonance Imaging Health Risperidone Abnormal Professional (Ngx)(Risperidone) SS 2 MG, QD Oculogyration Other Aripiprazole(Aripipr azole) SS 15 MG, QD, Olanzapine (Olanzapine0 C Date:03/21/05ISR Number: 4616047-6Report Type:Expedited (15-DaCompany Report #T05-GER-01061-01 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Cipramil (Citalopram Initial or Prolonged Priapism Study Hydrobromide) PS 20 MG QD Health Risperdal Professional (Risperidone) SS 3 MG QD Other Risperdal (Risperidone) SS ORAL 2 MG QD PO Risperdal (Risperidone) SS ORAL 1 MG QD PO Date:03/21/05ISR Number: 4616893-9Report Type:Expedited (15-DaCompany Report #2005042448 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Atarax (Tablet) Initial or Prolonged Dermatosis Health (Hydroxyzine Disorientation Professional Hydrochloride) PS ORAL 25 MG, ORAL Incoherent Tropatepine Pemphigoid Hydrochloride Pyrexia (Tropatepine Hydrochloride) SS ORAL ORAL Risperidone (Risperidone) SS ORAL 2 MG, ORAL Donepezil Hydrochloride (Donepezil Hydrochloride) SS ORAL 10 MG, ORAL 22-Feb-2006 08:20 AM Page: 2486 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/21/05ISR Number: 4620369-2Report Type:Direct Company Report #CTU 243883 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Risperdal PS ORAL 0.125MG Initial or Prolonged Cogwheel Rigidity DAILY ORAL Dizziness Risperdal C Hot Flush Seroquel C Hypersomnia Abilify C Musculoskeletal Stiffness Dexadrine C Tremor Depakote C Lexapro C Date:03/22/05ISR Number: 4614875-4Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12896098 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Disorder Fluphenazine Hcl PS Apothecon INTRAMUSCULAR Risperdal SS ORAL Epilim C Procyclidine C Levothyroxine C Zopiclone C Brufen C Date:03/23/05ISR Number: 4616121-4Report Type:Expedited (15-DaCompany Report #PT-JNJFOC-20050303036 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blister Risperdal Consta PS INTRAMUSCULAR dose status: Erythema temporarily Face Oedema interrupted Hypersensitivity Divalproate C OROPHARINGEAL total daily dose: 20 Olanzapine C OROPHARINGEAL total daily dose: 20 Diazepam C OROPHARINGEAL total daily dose: 15 Date:03/23/05ISR Number: 4616122-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050303052 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Risperdal Consta PS INTRAMUSCULAR Date:03/23/05ISR Number: 4616123-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050303448 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal Consta PS INTRAMUSCULAR Date:03/23/05ISR Number: 4616124-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050303997 Age:66 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:20 AM Page: 2487 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Hypernatraemia Risperdal PS OROPHARINGEAL Risperdal SS OROPHARINGEAL Raloxifene Hydrochloride C OROPHARINGEAL Sodium Rabeprazole C OROPHARINGEAL Ursodesoxycholic Acid C Pirenzepine Hydrochloride C OROPHARINGEAL Alfacalcidol C OROPHARINGEAL 1 mcg daily Date:03/23/05ISR Number: 4616125-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050300079 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Risperdal PS OROPHARINGEAL Death Risperdal SS OROPHARINGEAL Pulmonary Embolism Abilify SS OROPHARINGEAL Pyrexia Rivotril SS OROPHARINGEAL Respiratory Arrest Lepticur SS OROPHARINGEAL Lipanthyl SS OROPHARINGEAL Tercian SS OROPHARINGEAL Date:03/23/05ISR Number: 4616142-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050101615 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Risperdal PS UNKNOWN Initial or Prolonged Complete Risperdal SS UNKNOWN Other Depressed Level Of Clonazepam C Consciousness Etizolam C Pneumonia Respiratory Failure Sick Sinus Syndrome Sinus Arrest Transient Ischaemic Attack Date:03/23/05ISR Number: 4617036-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050103396 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atherosclerosis Risperdal Consta PS INTRAMUSCULAR Life-Threatening Myocardial Infarction Risperdal Consta SS INTRAMUSCULAR Diclofenac C OROPHARINGEAL Amoxicilline C OROPHARINGEAL Date:03/23/05ISR Number: 4617103-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-398349 Age:54 YR Gender:Female I/FU:I Outcome PT Death Blood Creatine Phosphokinase Increased Cardiac Arrest 22-Feb-2006 08:20 AM Page: 2488 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Electrocardiogram St-T Segment Elevation Feeling Abnormal Report Source Product Role Manufacturer Route Dose Duration Hyperkalaemia Rivotril PS Roche ORAL 3 DAY Psychomotor Hyperactivity Risperdal SS ORAL 895 DAY Respiratory Arrest Lipanthyl SS ORAL Tercian SS ORAL 15 DAY Abilify SS ORAL 18 DAY Lepticur SS ORAL 9 DAY Date:03/23/05ISR Number: 4620064-XReport Type:Direct Company Report #CTU 244081 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperidone 3 Mg PS ORAL 3 MG BID Decreased ORAL Date:03/24/05ISR Number: 4617470-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050304353 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brain Oedema Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Cerebrovascular Accident Risperdal Consta SS INTRAMUSCULAR Other Date:03/24/05ISR Number: 4617557-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050303358 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erythema Risperdal PS OROPHARINGEAL 61 MON Initial or Prolonged Mucosal Ulceration Aotal SS OROPHARINGEAL 7 DAY Stevens-Johnson Syndrome Tegretol SS OROPHARINGEAL 19 DAY Tegretol SS OROPHARINGEAL 19 DAY Surgam SS OROPHARINGEAL Ciblor SS OROPHARINGEAL Ciblor SS OROPHARINGEAL Date:03/24/05ISR Number: 4617558-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050303815 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Risperdal PS UNKNOWN Initial or Prolonged Electrocardiogram Qt Risperdal SS UNKNOWN (at bedtime) Prolonged Donepezil C Ventricular Extrasystoles Date:03/24/05ISR Number: 4621335-3Report Type:Direct Company Report #CTU 244189 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Erythema Risperdal 2mg PS ORAL 4MG DAILY Flushing ORAL Pruritus Generalised 22-Feb-2006 08:20 AM Page: 2489 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/05ISR Number: 4618977-8Report Type:Expedited (15-DaCompany Report #GB-ABBOTT-05P-167-0294584-00 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Valproate Sodium PS UNKNOWN Initial or Prolonged Drug Interaction Risperidone I UNKNOWN Pancytopenia Date:03/25/05ISR Number: 4619476-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050106806 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Dreams Risperdal PS OROPHARINGEAL Initial or Prolonged Amnesia Lithium SS OROPHARINGEAL Confusional State Lithium SS OROPHARINGEAL Dehydration Klonapin C OROPHARINGEAL Nasopharyngitis Effexor Xl C Nightmare Topamax C Therapeutic Agent Toxicity Urinary Tract Infection Date:03/25/05ISR Number: 4619477-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050304267 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Risperdal PS OROPHARINGEAL 2 DAY Death Risperdal SS OROPHARINGEAL 2 DAY Haematemesis Aspirin Dialuminate C OROPHARINGEAL 2 DAY Neuroleptic Malignant Aspirin Dialuminate C OROPHARINGEAL 2 DAY Syndrome Aspirin Dialuminate C OROPHARINGEAL 2 DAY Renal Failure Acute Date:03/25/05ISR Number: 4619478-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050304341 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS OROPHARINGEAL Zoloft SS OROPHARINGEAL Atosil C OROPHARINGEAL Date:03/25/05ISR Number: 4619479-5Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050304667 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Risperdal PS OROPHARINGEAL ALL REACTIONS Increased EXCEPT Constipation EXTRAPYRIMIDA Extrapyramidal Disorder L SYMPTOMS Sexual Dysfunction Risperdal SS OROPHARINGEAL EXTRAPYRIMIDA Somnolence L SYMPTOMS Weight Increased OCCURRED 22-Feb-2006 08:20 AM Page: 2490 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/05ISR Number: 4619480-1Report Type:Expedited (15-DaCompany Report #BR-JNJFOC-20050304979 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS Urinary Tract Infection Risperdal SS Reminyl SS Nimodipine C Norfloxacin C Date:03/25/05ISR Number: 4619481-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050305131 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Delusion Risperdal PS UNKNOWN Drug Effect Decreased Bifeprunox SS Fall Chlorpromazine C Hallucination Perphenazine C Benzhexol C Date:03/25/05ISR Number: 4619482-5Report Type:Expedited (15-DaCompany Report #FI-JNJFOC-20050300646 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Risperdal PS OROPHARINGEAL Initial or Prolonged Electrocardiogram Pq Kepra C OROPHARINGEAL Interval Prolonged Lamictal C OROPHARINGEAL Electrocardiogram Qt Absenor C OROPHARINGEAL Prolonged Lanzo C OROPHARINGEAL Pro-Epanutin C INTRAVENOUS Date:03/25/05ISR Number: 4619483-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050301645 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Risperdal Consta PS INTRAMUSCULAR Brain Oedema Risperdal Consta SS INTRAMUSCULAR Cardiac Arrest Risperdal C OROPHARINGEAL Cardio-Respiratory Arrest Leponex I OROPHARINGEAL Coma Drug Interaction Hyporeflexia Hypoxic Encephalopathy Pulmonary Embolism Respiratory Arrest Date:03/25/05ISR Number: 4619484-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041206038 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Drug Exposure During Risperdal PS OROPHARINGEAL Other Pregnancy Risperdal SS OROPHARINGEAL Foetal Growth Retardation Risperdal SS OROPHARINGEAL Platelet Count Decreased Risperdal SS OROPHARINGEAL Small For Dates Baby Oxytocin C Haldol C UNKNOWN Zopliclone C OROPHARINGEAL Nitrazepam C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2491 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/25/05ISR Number: 4619485-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050201334 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal PS OROPHARINGEAL Menstrual Disorder Risperdal SS OROPHARINGEAL White Blood Cell Count Risperdal SS OROPHARINGEAL Decreased Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Lorazepam C OROPHARINGEAL Promethazine Hydrochloride C Date:03/25/05ISR Number: 4619486-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041205690 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiomyopathy Risperdal PS OROPHARINGEAL Ventricular Dysfunction Risperdal SS OROPHARINGEAL Depakote C OROPHARINGEAL Date:03/25/05ISR Number: 4620648-9Report Type:Expedited (15-DaCompany Report #A01200501404 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angioneurotic Oedema Foreign Stilnox Dry Skin Health (Zolpidem) PS ORAL 100 MG ORAL 2 DAY Overdose Professional Risperidone SS ORAL 2 MG ORAL Other Fluvoxamine Maleate SS ORAL 50 MG ORAL 1 DAY Clozapine SS Date:03/25/05ISR Number: 4620705-7Report Type:Expedited (15-DaCompany Report #2005S1001135 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Consumer Clonidine Initial or Prolonged Loss Of Consciousness Health Hydrochloride Multiple Drug Overdose Professional Tablets, Usp (0.1 Suicide Attempt Mg) PS ORAL 2 MG; X1; PO Risperdal Tablets, (Janssen) (4 Mg) SS Janssen ORAL 160 MG; X1; PO Escitalopram C Venlafaxine C Hydrochloride C Clonazepam C Date:03/25/05ISR Number: 4620871-3Report Type:Expedited (15-DaCompany Report #FRWYE521621MAR05 Age:32 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blood Bicarbonate Initial or Prolonged Decreased Other Cogwheel Rigidity Hypertonia Neuroleptic Malignant 22-Feb-2006 08:20 AM Page: 2492 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Urinary Retention Report Source Product Role Manufacturer Route Dose Duration Foreign Seresta (Oxazepam) PS ORAL Health Artane Professional (Trihexyphenidyl) SS ORAL Other Loxapax (Loxapine) SS INTRAVENOUS Risperdal (Risperidone) SS ORAL Clopixol (Zuclopenthixol Decanoate) C INTRAVENOUS Tercian (Cyamemazine) C ORAL Nitrendipine C Bisoprolol Fumarate C Sulfarlem (Anethole Trithione) C Macrogol C Stilnox (Zolpidem) C Date:03/25/05ISR Number: 4621383-3Report Type:Expedited (15-DaCompany Report #S05-FRA-01077-01 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Foreign Aotal (Acamprosate) PS ORAL 333 MG TID PO Initial or Prolonged Health Tegretol Professional (Carbamazepine) SS ORAL 400 MG QD PO Other Tegretol (Carbamazepine) SS ORAL 200 MG QD PO Surgam (Tiaprofenic Acid) SS ORAL 100 MG BID PO Risperdal (Risperidone) SS ORAL 1 MG QD PO Ciblor SS ORAL 2000 MG QD PO Date:03/28/05ISR Number: 4619944-0Report Type:Expedited (15-DaCompany Report #DE-ABBOTT-05P-062-0290030-00 Age:24 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fatigue Akineton Tabletten PS ORAL Initial or Prolonged Suicide Attempt Ergenyl SS ORAL Unevaluable Event Risperidone SS ORAL Hashish SS Date:03/28/05ISR Number: 4620048-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050206554 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Disorder Risperdal Consta PS OTHER Death 22-Feb-2006 08:20 AM Page: 2493 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/28/05ISR Number: 4621578-9Report Type:Expedited (15-DaCompany Report #5469 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Fluphenazine PS INTRAMUSCULAR 25 MG FREQ Initial or Prolonged Sedation Health UNK, IM Urinary Tract Infection Professional Risperidone SS ORAL 1 MG MANE/2 Other MG NOCTE, PO Lorazepam SS ORAL 1 MG NOCTE, PO Date:03/29/05ISR Number: 4621683-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050303718 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Somnolence Risperdal PS OROPHARINGEAL Initial or Prolonged Unresponsive To Pain Imovane SS OROPHARINGEAL Stimuli Topalgic SS OROPHARINGEAL Flixotide C 3 PUFFS PER DAY Aprovel C Cortancyl C Actonel C Mopral C Hemigoxine C Caltrate C Date:03/29/05ISR Number: 4621684-9Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20050301128 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyperthermia Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Pneumonia Other Suicide Attempt Date:03/29/05ISR Number: 4621685-0Report Type:Periodic Company Report #US-JNJFOC-20041103377 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Crohn'S Disease Risperdal PS OROPHARINGEAL Hospitalization - Myocardial Infarction Glucotrol C Initial or Prolonged Actose C Lipitor C Asacol C Pepcid C Flexeril C Date:03/29/05ISR Number: 4621686-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050102782 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Withdrawal Syndrome Risperdal PS OROPHARINGEAL Pancreatitis Risperdal SS OROPHARINGEAL Zotepine C Quietapine Fumarate C Carbamazepine C Chlorpromazine Hydrochloride C 22-Feb-2006 08:20 AM Page: 2494 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trihexyphenidyl Hydrochloride C Nitrazepam C Lorazepam C Triazolam C Mosapride Citrate C Flunitrazepam C Date:03/30/05ISR Number: 4622634-1Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20050203212 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Breast Neoplasm Risperdal PS OROPHARINGEAL Hyperprolactinaemia Haldol SS 10 drops for Pain +-1 year Date:03/30/05ISR Number: 4622635-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050203675 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Complication Risperdal PS OROPHARINGEAL Date:03/30/05ISR Number: 4622636-5Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20050206201 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Risperdal PS Self Injurious Behaviour Methylphenidate C 20 mg at 0700, 15 mg at noon, and 10 mg at 1600 hours. Date:03/30/05ISR Number: 4622637-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050202110 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Status Epilepticus Risperdal PS OROPHARINGEAL Hospitalization - Suicide Attempt Risperdal SS OROPHARINGEAL Initial or Prolonged Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Flunitrazepam C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2495 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL Lorazepam C OROPHARINGEAL Nitrazepam C OROPHARINGEAL Nitrazepam C OROPHARINGEAL Famotidine C OROPHARINGEAL 52 DAY Famotidine C OROPHARINGEAL 52 DAY Clonazepam C Date:03/30/05ISR Number: 4623442-8Report Type:Expedited (15-DaCompany Report #2005046658 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Foreign Sertraline Tardive Dyskinesia Health (Sertraline) PS ORAL (200 MG), Professional ORAL Risperidone (Risperidone) SS ORAL (4 MG), ORAL Indoramin (Indoramin) C Tamsulosin (Tamsulosin) C Paramol-118 (Dihydrocodeine Bitartrate, Paracetamol) C Irbesartan (Irbesartan) C Omeprazole (Omeprazole) C Metformin (Metformin) C Insulin (Insulin) C Date:03/31/05ISR Number: 4623757-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050204694 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bradykinesia Risperdal PS OROPHARINGEAL Hypothermia Risperdal SS OROPHARINGEAL Liver Disorder Risperdal SS OROPHARINGEAL Malnutrition Risperdal SS OROPHARINGEAL Obstructive Airways Brotizolam C OROPHARINGEAL Disorder Nitrazepam C OROPHARINGEAL Urinary Tract Infection Sennoside C Magnesium Oxide C OROPHARINGEAL Mosapride Citrate C Pantethine C Olanzapine C OROPHARINGEAL Date:03/31/05ISR Number: 4623758-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041200939 Age: Gender:Female I/FU:I Outcome PT Other Catatonia Chest Pain Cogwheel Rigidity 22-Feb-2006 08:20 AM Page: 2496 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Interaction Hallucination Incoherent Report Source Product Role Manufacturer Route Dose Duration Pollakiuria Risperdal PS OROPHARINGEAL Rhabdomyolysis Risperdal SS OROPHARINGEAL Syncope Flunitrazepam C OROPHARINGEAL Tremor Chinese Medicines C Sulpiride C OROPHARINGEAL Atorvastatin Calcium I Date:03/31/05ISR Number: 4623759-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050200192 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Conversion Disorder Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Hyperglycaemia Other Respiratory Depression Tachycardia Date:03/31/05ISR Number: 4623883-9Report Type:Expedited (15-DaCompany Report #FR-MERCK-0411FRA00103 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Crixivan PS Merck & Co., Inc ORAL 17 DAY Initial or Prolonged Zidovudine SS ORAL 17 DAY Risperidone SS ORAL Ritonavir C ORAL 17 DAY Sulfamethoxazole And Trimethoprim C ORAL Buprenorphine Hydrochloride C ORAL Fluconazole C ORAL Date:03/31/05ISR Number: 4624025-6Report Type:Expedited (15-DaCompany Report #PHBS2005DE02352 Age:27 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Clozapine PS Novartis Sector: Disturbance In Attention Pharma UNKNOWN 250 mg/d Fatigue Lorazepam SS UNKNOWN 1 mg/d Increased Appetite Haloperidol SS Libido Decreased Zotepine SS Salivary Hypersecretion Risperidone SS UNKNOWN 6 mg/d Weight Increased Date:03/31/05ISR Number: 4624182-1Report Type:Expedited (15-DaCompany Report #2005/00039 Age:31 YR Gender:Male I/FU:I Outcome PT Hospitalization - Blister Initial or Prolonged Conjunctivitis Erythema Lip Erosion Mucosal Ulceration Pain Pyrexia Stevens-Johnson Syndrome 22-Feb-2006 08:20 AM Page: 2497 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tonsillitis Report Source Product Role Manufacturer Route Dose Duration Ciblor PS Glaxosmithkline ORAL 2G Per day Aotal SS ORAL 3TAB Per day 7 DAY Tegretol SS ORAL 200MG Per day 19 DAY Tegretol SS ORAL 400MG Per day 18 DAY Surgam SS ORAL 2TAB Per day Risperdal SS ORAL 1MG per day Date:03/31/05ISR Number: 4627058-9Report Type:Expedited (15-DaCompany Report #2005AL001186 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Increased Foreign Serax (Oxazepam) Initial or Prolonged Neuroleptic Malignant Other Tablets, 15 Mg Required Syndrome (Alpharma) (Serax Intervention to (Oxazepam) Tablets, Prevent Permanent 15 (Alpharma)) PS Alpharma ORAL PO Impairment/Damage Artane () SS ORAL PO Zuclopenthixol Decanoate () SS INTRAVENOUS IV Loxapac () SS IV Risperdal () SS ORAL PO Tercian () SS ORAL PO Nitrendipine C Bisoprolol Fumarate C Sulfarlem C Macrogol C Stillnox C Date:04/01/05ISR Number: 4624993-2Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050304667 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Risperdal PS OROPHARINGEAL ALL REACTIONS Increased EXCEPT Constipation EXTRAPYRIMIDA Extrapyramidal Disorder L SYMPTOMS Sexual Dysfunction Risperdal SS OROPHARINGEAL EXTRAPYRIMIDA Somnolence L SYMPTOMS Weight Increased OCCURRED Date:04/01/05ISR Number: 4624994-4Report Type:Periodic Company Report #IE-JNJFOC-20040909781 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Risperdal Consta PS INTRAMUSCULAR Abnormal Risperdal Consta SS INTRAMUSCULAR Thyroid Disorder Motilium C Zoton C Eltroxin C 22-Feb-2006 08:20 AM Page: 2498 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/05ISR Number: 4626006-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050306802 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Cirrhosis Risperdal PS OROPHARINGEAL Hepatitis C Cogentin C OROPHARINGEAL Date:04/04/05ISR Number: 4626007-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050202281 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Biliary Cirrhosis Primary Risperdal PS OROPHARINGEAL Liver Function Test Ursodeoxycholic Acid C 250 mg/mL Abnormal Date:04/04/05ISR Number: 4626008-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050300079 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Risperdal PS OROPHARINGEAL Cardiac Arrest Risperdal SS OROPHARINGEAL Death Abilify SS OROPHARINGEAL Fall Lepticur SS OROPHARINGEAL Psychomotor Hyperactivity Tercian SS OROPHARINGEAL Pulmonary Embolism Lipanthyl SS OROPHARINGEAL Pyrexia Rivotril SS OROPHARINGEAL Respiratory Arrest Risperdal SS OROPHARINGEAL Suicidal Ideation Sulfarlem C Prozac C Date:04/04/05ISR Number: 4626009-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041008024 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Megaloblastic Risperdal PS OROPHARINGEAL Initial or Prolonged Risperdal SS OROPHARINGEAL Phenobarb SS Chlorpromazine Promethazine SS Chlorpromazine Promethazine SS Chlorpromazine Promethazine SS Nitrazepam C Nitrazepam C Sennoside C Flunitrazepam C Quazepam C Date:04/04/05ISR Number: 4626050-8Report Type:Expedited (15-DaCompany Report #FR-MERCK-0411FRA00103 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Crixivan PS Merck & Co., Inc ORAL 17 DAY Initial or Prolonged Zidovudine SS ORAL 17 DAY Risperidone SS ORAL Ritonavir C ORAL 17 DAY Sulfamethoxazole And 22-Feb-2006 08:20 AM Page: 2499 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trimethoprim C ORAL Buprenorphine Hydrochloride C ORAL Fluconazole C ORAL Date:04/04/05ISR Number: 4626240-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050303997 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Risperdal PS OROPHARINGEAL Hospitalization - Blood Creatinine Risperdal SS OROPHARINGEAL Initial or Prolonged Increased Raloxifene Blood Urea Increased Hydrochloride C OROPHARINGEAL Dehydration Sodium Rabeprazole C OROPHARINGEAL Hypernatraemia Ursodesoxycholic Insomnia Acid C Pirenzepine Hydrochloride C OROPHARINGEAL Alfacalcidol C OROPHARINGEAL 1 mcg daily Date:04/04/05ISR Number: 4626372-0Report Type:Expedited (15-DaCompany Report #BE-BRISTOL-MYERS SQUIBB COMPANY-12907242 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Lithium Carbonate PS Initial or Prolonged Confusional State Levomepromazine SS Dehydration Spironolactone SS Diarrhoea Furosemide SS Drug Interaction Escitalopram SS Dysarthria Lormetazepam C Lethargy Repaglinide C Oliguria Metformin Hcl C Bristol-Myers Squibb Therapeutic Agent Company Toxicity Irbesartan I Bristol-Myers Squibb Tremor Company Prinivil I ORAL Risperidone I Date:04/05/05ISR Number: 4626836-XReport Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12899621 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Abilify Tabs 15 Mg PS Otsuka Other Phosphokinase Increased Pharmaceutical Cardiac Arrest Company, Ltd. ORAL Electrocardiogram St Lepticur SS Segment Elevation Rivotril SS Fall Tercian SS ORAL Hyperkalaemia Lipanthyl SS ORAL Malaise Risperdal SS Psychomotor Hyperactivity Respiratory Arrest 22-Feb-2006 08:20 AM Page: 2500 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/05ISR Number: 4626938-8Report Type:Expedited (15-DaCompany Report #CH-MERCK-0504CHE00002 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Hyzaar PS Merck & Co., Inc ORAL Initial or Prolonged Fatigue Furosemide Sodium SS ORAL Hypotension Glibornuride SS ORAL Muscle Rigidity Biperiden Neuroleptic Malignant Hydrochloride SS UNKNOWN Syndrome Biperiden Pyrexia Hydrochloride SS UNKNOWN Tachycardia Risperidone SS ORAL Urinary Incontinence Valproate Sodium C ORAL Lorazepam C ORAL Aspirin C ORAL Metformin Hydrochloride C ORAL Date:04/05/05ISR Number: 4626979-0Report Type:Periodic Company Report #PT-JNJFOC-20050105115 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Risperdal PS OROPHARINGEAL Initial or Prolonged Agitation Other Coordination Abnormal Extrapyramidal Disorder Eye Movement Disorder Date:04/05/05ISR Number: 4626980-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050106806 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Dreams Risperdal PS OROPHARINGEAL Initial or Prolonged Amnesia Lithium SS OROPHARINGEAL Confusional State Lithium SS OROPHARINGEAL Dehydration Klonapin C OROPHARINGEAL Drug Interaction Effexor Xl C Nasopharyngitis Topamax C Nightmare Therapeutic Agent Toxicity Urinary Tract Infection Date:04/05/05ISR Number: 4627524-6Report Type:Expedited (15-DaCompany Report #HQWYE333024MAR05 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ammonia Increased Literature Effexor Xr Hospitalization - Blood Pressure Increased (Venlafaxine Initial or Prolonged Brain Oedema Hydrochloride, Cerebral Circulatory Capsule, Extended Failure Release) PS ORAL 3 G (OVERDOSE Completed Suicide AMOUNT); ORAL Intentional Overdose Risperidone Tachycardia (Risperidone, ) SS ORAL 60 MG (OVERDOSE AMOUNT); ORAL Valproic Acid (Valproic Acid, ) SS ORAL 20 G 22-Feb-2006 08:20 AM Page: 2501 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (OVERDOSE AMOUNT); ORAL Date:04/05/05ISR Number: 4657388-6Report Type:Periodic Company Report #2004054027 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Health Geodon (Ziprasidone) PS Abnormal Professional Risperidone Company (Risperidone) SS Representative Lamotrigine (Lamotrigine) SS Citalopram Hydrobromide (Citalopram Hydrobromide) C All Other Therapeutic Products (All Other Therapeutic Products) C Date:04/05/05ISR Number: 4657597-6Report Type:Periodic Company Report #2004026994 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Health Geodon (Ziprasidone) PS ORAL 160 MG (80, 2 Initial or Prolonged Phosphokinase Increased Professional IN 1 D), ORAL Other Micturition Disorder Company Risperidone Neck Pain Representative (Risperidone) SS Syncope Clonazepam White Blood Cell Count (Clonazepam) C Increased Propranolol Hydrochloride (Propranolol Hydrochloride) C Tocopherol (Tocopherol) C Date:04/06/05ISR Number: 4628253-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050306976 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Shock Risperdal PS OROPHARINGEAL Sleep Disorder Brotizolam C Date:04/06/05ISR Number: 4628254-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050204691 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Somnolence Risperdal PS OROPHARINGEAL White Blood Cell Count Risperdal SS OROPHARINGEAL Decreased Famotidine C OROPHARINGEAL Parenteral Nutrition C INTRAVENOUS Parenteral Nutrition C INTRAVENOUS Parenteral Nutrition C INTRAVENOUS Parenteral Nutrition C INTRAVENOUS Diazepam C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2502 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lormetazepam C OROPHARINGEAL Date:04/06/05ISR Number: 4628613-2Report Type:Expedited (15-DaCompany Report #FR-MERCK-0409FRA00072 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Zocor PS Merck & Co., Inc ORAL Initial or Prolonged Dysstasia Fluoxetine Disability Fall Hydrochloride SS ORAL Peripheral Sensorimotor Risperidone SS ORAL Neuropathy Acepromazine And Rhabdomyolysis Aceprometazine And Clorazepate Dipotassium SS ORAL Zopiclone SS ORAL Levothyroxine Sodium C ORAL Date:04/06/05ISR Number: 4629686-3Report Type:Expedited (15-DaCompany Report #S05-FRA-01077-01 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Foreign Aotal (Acamprosate) PS ORAL 333 MG TID PO Initial or Prolonged Health Tegretol Professional (Carbamazepine) SS ORAL 400 MG QD PO Other Tegretol (Carbamazepine) SS ORAL 200 MGQD PO Surgam(Tiaprofenic Acid) SS ORAL 100 MG BID PO Risperdal (Risperidone) SS 1 MG QD PO Ciblor SS ORAL 2000 MG QD PO Date:04/06/05ISR Number: 4631021-1Report Type:Direct Company Report #CTU 245512 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Risperdal PS ORAL 2 MG PO DAILY Feeling Abnormal Effexor C Hyperhidrosis Unspecified :Mood Palpitations Stabilizer" C Panic Attack Urinary Incontinence Date:04/06/05ISR Number: 4631120-4Report Type:Direct Company Report #CTU 245522 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Risperdal PS Janssen ORAL 3 MG ORALLY Q Initial or Prolonged Depression HS Tegretol C Phenobarbitol C 22-Feb-2006 08:20 AM Page: 2503 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/07/05ISR Number: 4629180-XReport Type:Expedited (15-DaCompany Report #FR-SANOFI-SYNTHELABO-A02200500860 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Stilnox PS ORAL Initial or Prolonged Gastric Haemorrhage Lysanxia SS ORAL Akineton Retard SS ORAL Risperdal SS ORAL Date:04/07/05ISR Number: 4630933-2Report Type:Direct Company Report #CTU 245659 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - White Blood Cell Count Risperidone PS ORAL 4MG, 2MG BID, Initial or Prolonged Decreased ORAL Date:04/08/05ISR Number: 4630000-8Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050307177 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autoimmune Hepatitis Risperdal PS UNKNOWN Initial or Prolonged Hepatitis Cholestatic Fluoxetine C UNKNOWN Carbamazepine C UNKNOWN Date:04/08/05ISR Number: 4630001-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050307360 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Risperdal PS OROPHARINGEAL Gastrointestinal Stilnox SS OROPHARINGEAL Haemorrhage Lysanxia SS OROPHARINGEAL Date:04/08/05ISR Number: 4630002-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050107016 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Localised Infection Risperdal PS OROPHARINGEAL Penile Swelling Risperdal SS OROPHARINGEAL Swelling Face Urticaria White Blood Cell Count Decreased Date:04/08/05ISR Number: 4630003-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050104087 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS OROPHARINGEAL Atosil SS Date:04/08/05ISR Number: 4630004-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041102388 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal PS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2504 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/08/05ISR Number: 4630005-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050203254 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Risperdal Consta PS INTRAMUSCULAR The patient Syndrome received 1 Ventricular Fibrillation dose. Zoloft C Zyprexa C Artane C Viracept C Combivent C Combivent C Date:04/08/05ISR Number: 4630056-2Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0295896-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Akineton PS ORAL Initial or Prolonged Gastrointestinal Prazepam SS ORAL Haemorrhage Zolpidem Tartrate SS ORAL Risperidone SS ORAL Date:04/08/05ISR Number: 4630296-2Report Type:Expedited (15-DaCompany Report #200510860EU Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Lasix PS Aventis Initial or Prolonged Chills Pharmaceuticals Inc. ORAL Extrapyramidal Disorder Risperdal SS ORAL Fatigue Glutril SS ORAL General Physical Health Akineton SS Deterioration Cosaar Plus SS Hypotension Orfiril C ORAL Muscle Rigidity Temesta C ORAL Neuroleptic Malignant Aspirin Cardio C ORAL Syndrome Glucophage C ORAL Pyrexia Tachycardia Urinary Incontinence Date:04/08/05ISR Number: 4630667-4Report Type:Expedited (15-DaCompany Report #FR-SANOFI-SYNTHELABO-A02200500846 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Stilnox PS ORAL Gastrointestinal Risperdal SS ORAL Haemorrhage Lysanxia SS ORAL Zyprexa C UNKNOWN 1 DAY Date:04/08/05ISR Number: 4630668-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050400406 Age: Gender:Female I/FU:I Outcome PT Other Hyperhidrosis Muscle Rigidity Neuroleptic Malignant Syndrome 22-Feb-2006 08:20 AM Page: 2505 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oily Skin Staring Report Source Product Role Manufacturer Route Dose Duration Risperdal PS OROPHARINGEAL Risperdal SS OROPHARINGEAL Date:04/08/05ISR Number: 4630669-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050103396 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Risperdal Consta PS INTRAMUSCULAR Life-Threatening Atherosclerosis Risperdal Consta SS INTRAMUSCULAR Circulatory Collapse Diclofenac C OROPHARINGEAL Myocardial Infarction Amoxicilline C OROPHARINGEAL Prostatic Disorder Resuscitation Date:04/08/05ISR Number: 4630670-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050304267 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Risperdal PS OROPHARINGEAL 3 DAY Hospitalization - Anger Risperdal SS OROPHARINGEAL 3 DAY Initial or Prolonged Arrhythmia Aspirin Dialuminate C OROPHARINGEAL 3 DAY Cerebral Infarction Aspirin Dialuminate C OROPHARINGEAL 3 DAY Confusional State Aspirin Dialuminate C OROPHARINGEAL 3 DAY Death Dementia Electroencephalogram Abnormal Faecal Incontinence Haematemesis Memory Impairment Neuroleptic Malignant Syndrome Parkinson'S Disease Persecutory Delusion Renal Failure Acute Sleep Disorder Urinary Incontinence Date:04/08/05ISR Number: 4630671-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050106697 Age:12 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Bundle Branch Block Right Risperdal PS OROPHARINGEAL Other Dizziness Risperdal SS OROPHARINGEAL Malaise Strattera SS OROPHARINGEAL Orthostatic Hypotension Strattera SS OROPHARINGEAL Palpitations Risperdal SS OROPHARINGEAL Date:04/08/05ISR Number: 4630672-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050200565 Age:75 YR Gender:Male I/FU:I Outcome PT Other Anaemia Carotid Artery Occlusion 22-Feb-2006 08:20 AM Page: 2506 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cerebral Atrophy Cerebrovascular Accident Myocardial Infarction Report Source Product Role Manufacturer Route Dose Duration Transient Ischaemic Risperdal PS Attack Stelazine C Depakote C Benzatropine C Prozac C Cymbalta C Date:04/08/05ISR Number: 4630742-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-398349 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Rivotril PS Roche ORAL 3 DAY Phosphokinase Increased Risperdal SS ORAL 895 DAY Cardiac Arrest Lipanthyl SS ORAL Electrocardiogram St Tercian SS ORAL 15 DAY Segment Elevation Abilify SS ORAL 18 DAY Feeling Abnormal Lepticur SS ORAL 9 DAY Hyperkalaemia Psychomotor Hyperactivity Respiratory Arrest Date:04/08/05ISR Number: 4630770-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050201007 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Neoplasm Risperdal PS OROPHARINGEAL Date:04/08/05ISR Number: 4632791-9Report Type:Direct Company Report #CTU 245687 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Suicide Attempt Risperdal 2 Mg Initial or Prolonged Jannsen PS Jannsen ORAL 2 MG ORALLY BID Date:04/11/05ISR Number: 4632331-4Report Type:Expedited (15-DaCompany Report #CH-MERCK-0504CHE00002 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Hyzaar PS Merck & Co., Inc ORAL Initial or Prolonged Fatigue Furosemide Sodium SS ORAL Hypotension Glibornuride SS ORAL Muscle Rigidity Biperiden Neuroleptic Malignant Hydrochloride SS UNKNOWN Syndrome Biperiden Pyrexia Hydrochloride SS UNKNOWN Tachycardia Risperidone SS ORAL Urinary Incontinence Valproate Sodium C ORAL Lorazepam C ORAL Aspirin C ORAL Metformin Hydrochloride C ORAL 22-Feb-2006 08:20 AM Page: 2507 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/05ISR Number: 4632465-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050304663 Age:28 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alpha Hydroxybutyrate Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Dehydrogenase Increased Risperdal C OROPHARINGEAL Other Blood Lactate Tavor C Dehydrogenase Increased Extrapyramidal Disorder Hepatic Enzyme Increased Date:04/11/05ISR Number: 4632466-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050307358 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Risperdal PS OROPHARINGEAL Initial or Prolonged Gastrointestinal Lysanxia SS OROPHARINGEAL Haemorrhage Akineton SS OROPHARINGEAL 1tablet per day Stilnox SS OROPHARINGEAL Date:04/11/05ISR Number: 4632488-5Report Type:Expedited (15-DaCompany Report #US-ABBOTT-05P-163-0296109-00 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Systolic Valproic Acid PS ORAL Other Increased Risperidone SS ORAL Brain Death Venlafaxine SS ORAL Brain Herniation Brain Oedema Drug Level Increased Encephalopathy Hyperammonaemia Intentional Overdose Lethargy Mental Status Changes Posturing Pupil Fixed Tachycardia Date:04/11/05ISR Number: 4632583-0Report Type:Expedited (15-DaCompany Report #CH-MERCK-0504CHE00002 Age:72 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Hyzaar PS Merck & Co., Inc ORAL Initial or Prolonged Fatigue Furosemide Sodium SS ORAL Hypotension Glibornuride SS ORAL Muscle Rigidity Biperiden Neuroleptic Malignant Hydrochloride SS UNKNOWN Syndrome Biperiden Pyrexia Hydrochloride SS UNKNOWN Tachycardia Risperidone SS ORAL Urinary Incontinence Valproate Sodium C ORAL Lorazepam C ORAL Aspirin C ORAL Metformin Hydrochloride C ORAL 22-Feb-2006 08:20 AM Page: 2508 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/05ISR Number: 4632911-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050401115 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tardive Dyskinesia Risperdal PS UNKNOWN Initial or Prolonged Risperdal SS UNKNOWN Date:04/12/05ISR Number: 4632912-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040504990 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Risperidone PS OROPHARINGEAL Drug Exposure During Risperidone SS OROPHARINGEAL Pregnancy Risperidone SS OROPHARINGEAL Drug Exposure Via Breast Risperidone SS OROPHARINGEAL Milk Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL Bromperidol C UNKNOWN Bromperidol C UNKNOWN Biperiden C UNKNOWN Biperiden C UNKNOWN Haloperidol C INTRAVENOUS Haloperidol C UNKNOWN Haloperidol C UNKNOWN Haloperidol C UNKNOWN Haloperidol C UNKNOWN Haloperidol C UNKNOWN Haloperidol C UNKNOWN Haloperidol C UNKNOWN Haloperidol C UNKNOWN Haloperidol C UNKNOWN Haloperidol C INTRAMUSCULAR Haloperidol C INTRAMUSCULAR Haloperidol C INTRAMUSCULAR Diazepam C INTRAVENOUS Chlorpromazine C UNKNOWN Promethazine C UNKNOWN Date:04/12/05ISR Number: 4633061-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050307387 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Abscess Risperdal PS OROPHARINGEAL Initial or Prolonged Depakote C 22-Feb-2006 08:20 AM Page: 2509 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/05ISR Number: 4633089-5Report Type:Expedited (15-DaCompany Report #FR-SANOFI-SYNTHELABO-A02200500846 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Stilnox PS ORAL Gastrointestinal Risperdal SS ORAL Haemorrhage Lysanxia SS ORAL Zyprexa C UNKNOWN 1 DAY Date:04/13/05ISR Number: 4634048-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050400734 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal Consta PS INTRAMUSCULAR Phosphokinase Increased Risperdal Consta SS INTRAMUSCULAR Drug Ineffective Risperdal SS OROPHARINGEAL Date:04/13/05ISR Number: 4634049-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050400772 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal PS UNKNOWN Hospitalization - Initial or Prolonged Date:04/13/05ISR Number: 4634050-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050202281 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Antimitochondrial Risperdal PS OROPHARINGEAL Antibody Positive Ursodeoxycholic Acid C 250 mg/mL Biliary Cirrhosis Primary Liver Function Test Abnormal Date:04/13/05ISR Number: 4634147-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050402047 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Choking Risperdal PS OROPHARINGEAL Other Sodium Valproate C OROPHARINGEAL Sodium Valproate C OROPHARINGEAL Sodium Valproate C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Bromocriptine Mesylate C OROPHARINGEAL Amezinium Metilsulfate C OROPHARINGEAL Date:04/13/05ISR Number: 4636169-3Report Type:Direct Company Report #CTU 246079 Age:38 YR Gender:Female I/FU:I Outcome PT Other Amnesia Hypertension Nasal Congestion 22-Feb-2006 08:20 AM Page: 2510 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vision Blurred Weight Increased Report Source Product Role Manufacturer Route Dose Duration Depakote PS 3 TABLETS 250 MG , DLY Resperdal SS 1 TBLT 20 MG, DLY Date:04/14/05ISR Number: 4634922-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050106806 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Risperdal PS OROPHARINGEAL Initial or Prolonged Confusional State Risperdal SS OROPHARINGEAL one dose Dehydration Lithium SS OROPHARINGEAL Myocardial Infarction Lithium SS OROPHARINGEAL Nasopharyngitis Klonapin C OROPHARINGEAL Nightmare Effexor Xl C Therapeutic Agent Topamax C Toxicity Urinary Tract Infection Date:04/14/05ISR Number: 4634938-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050400706 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Haldol PS OROPHARINGEAL Corrected Interval Risperdal SS OROPHARINGEAL Prolonged Eunerpan SS OROPHARINGEAL Diazepam SS OROPHARINGEAL Date:04/14/05ISR Number: 4635205-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050401518 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Risperdal PS OROPHARINGEAL Initial or Prolonged Convulsion Namenda C OROPHARINGEAL Fall Aricept C OROPHARINGEAL Heart Rate Irregular Dilantin C Transient Ischaemic Sotolol C OROPHARINGEAL Attack Escitalopram C Date:04/14/05ISR Number: 4635206-XReport Type:Expedited (15-DaCompany Report #NSADSS2003023054 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Risperdal PS UNKNOWN Hospitalization - Extrapyramidal Disorder Serax C Initial or Prolonged Hallucination Tylenol C Headache Iron C Insomnia Glucophage C Obsessive-Compulsive Disorder Parkinson'S Disease Pneumonia Aspiration Sedation 22-Feb-2006 08:20 AM Page: 2511 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/05ISR Number: 4636382-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050301300 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Poisoning Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Blood Creatine Other Phosphokinase Increased Fall Suicidal Ideation Date:04/15/05ISR Number: 4636383-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050401359 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cogwheel Rigidity Risperdal PS OROPHARINGEAL Initial or Prolonged Pain In Extremity Aspirin C OROPHARINGEAL Perindopril C OROPHARINGEAL Perindopril C OROPHARINGEAL Sertraline C OROPHARINGEAL Atenolol C OROPHARINGEAL Date:04/15/05ISR Number: 4636384-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050401453 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Risperdal PS OROPHARINGEAL Initial or Prolonged Risperdal SS OROPHARINGEAL Zelitrex SS OROPHARINGEAL Adiazine C Depakine C Malocide C Triflucan C Date:04/15/05ISR Number: 4636385-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050401774 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ventricular Hypertrophy Risperdal PS OROPHARINGEAL Date:04/15/05ISR Number: 4636789-6Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-04P-056-0280947-00 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Norvir Soft Gelatin Initial or Prolonged Capsules PS ORAL 16 DAY Risperidone SS ORAL Zidovudine SS ORAL 16 DAY Bactrim SS ORAL Buprenorphine Hydrochloride SS SUBLINGUAL Indinavir Sulfate SS ORAL 16 DAY Fluconazole C ORAL Olanzapine C ORAL Filgrastim C 5 DAY Kaletra Soft Gelatin Capsules C ORAL Lamivudine C ORAL Didanosine C ORAL 22-Feb-2006 08:20 AM Page: 2512 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/05ISR Number: 4639823-2Report Type:Expedited (15-DaCompany Report #A02200500846 Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Stilnox - (Zolpidem) Gastrointestinal Professional - Tablet - 10 Mg PS ORAL 10 MG OD Haemorrhage Risperdal - (Risperidone) - Tablet - 8 Mg SS ORAL 8 MG QD : 27 WEEKS 4 DAYS Lysanxa - (Prazepam) - Tablet - 10 Mg SS ORAL 10 MG QD; 27 WEEKS 4 DAYS Zyprexa (Olanzapine) C Date:04/18/05ISR Number: 4637522-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050305477 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ejaculation Failure Risperdal Consta PS INTRAMUSCULAR Eosinophilia Clonazepam C Date:04/18/05ISR Number: 4637523-6Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20030704666 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Psychosis Risperdal PS OROPHARINGEAL 7 DAY Acute Respiratory Risperdal SS OROPHARINGEAL 7 DAY Distress Syndrome Largactil SS The dose was Hypotension reduced on Neuroleptic Malignant 11-JUL-2003 Syndrome Dolcontin C OROPHARINGEAL Pneumonia Paracet C OROPHARINGEAL Sepsis Clarityn C OROPHARINGEAL Tachycardia Mycostatin C OROPHARINGEAL Afipran C OROPHARINGEAL Penicillin C INTRAVENOUS Naxogin C OROPHARINGEAL Levaxin C OROPHARINGEAL Entocort C OROPHARINGEAL Somac C OROPHARINGEAL Vioxx C OROPHARINGEAL Cisplatin C PARENTERAL Sobril C OROPHARINGEAL Selexid C OROPHARINGEAL Date:04/18/05ISR Number: 4637524-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050203172 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Risperdal Consta PS INTRAMUSCULAR Syndrome 22-Feb-2006 08:20 AM Page: 2513 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/18/05ISR Number: 4637643-6Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0377207A Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Zelitrex PS Glaxosmithkline ORAL 1G Three Initial or Prolonged times per day 19 DAY Risperdal SS ORAL 2MG Per day 11 DAY Adiazine C ORAL 4G per day Depakine C ORAL 500MG Twice per day Malocide C Glaxosmithkline ORAL 50MG Per day Triflucan C ORAL 200MG Per day Hiv Treatments (Unspecified) C Haldol C Date:04/18/05ISR Number: 4637918-0Report Type:Expedited (15-DaCompany Report #JP-ROCHE-398695 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Tamiflu PS Roche ORAL 1 DAY Phosphokinase Increased Tamiflu SS Roche ORAL 4 DAY Tamiflu SS Roche ORAL 1 DAY Risperdal SS ORAL Flomox SS ORAL 5 DAY Akineton SS ORAL Marzulene C ORAL 6 DAY Calonal C ORAL 4 DAY Isodine C ORAL FORM: GARGLE Seroquel C ORAL Selbex C ORAL Zyprexa C ORAL Vegetamin B C ORAL Pursennid C ORAL Alesion C ORAL 5 DAY Coughcode C ORAL 3 DAY Mucodyne C ORAL 3 DAY Date:04/18/05ISR Number: 4638683-3Report Type:Direct Company Report #CTU 246391 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperidone PS ORAL 2 MG PO DAILY Date:04/19/05ISR Number: 4638876-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050401778 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Risperdal PS OROPHARINGEAL Initial or Prolonged Mydriasis Risperdal SS OROPHARINGEAL Overdose Risperdal SS OROPHARINGEAL OVERDOSE DOSAGE 22-Feb-2006 08:20 AM Page: 2514 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/19/05ISR Number: 4638877-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050401789 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Risperdal Consta PS INTRAMUSCULAR for over two Tinnitus years Date:04/19/05ISR Number: 4638878-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050402185 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal PS OROPHARINGEAL Decreased Date:04/19/05ISR Number: 4638879-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050402682 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Risperdal PS UNKNOWN Liver Disorder Lithium C Sarcoidosis Seroquel C Synthroid C Date:04/19/05ISR Number: 4638880-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050403035 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Risperidone PS OROPHARINGEAL Depressed Level Of Nitrazepam C OROPHARINGEAL Consciousness Pipsissewa Extract C OROPHARINGEAL Hypothermia Tamsulosin Hydrochloride C OROPHARINGEAL Clarithromycin C OROPHARINGEAL Clonazepam C OROPHARINGEAL Date:04/19/05ISR Number: 4638881-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050303997 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Risperdal PS OROPHARINGEAL Hospitalization - Blood Urea Increased Risperdal SS OROPHARINGEAL Initial or Prolonged Dehydration Raloxifene Depressed Level Of Hydrochloride C OROPHARINGEAL Consciousness Sodium Rabeprazole C OROPHARINGEAL Hypernatraemia Ursodesoxycholic Insomnia Acid C Pirenzepine Hydrochloride C OROPHARINGEAL Alfacalcidol C OROPHARINGEAL 1 mcg daily Date:04/19/05ISR Number: 4638882-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041105503 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Disorder Risperdal Consta PS INTRAMUSCULAR 22-Feb-2006 08:20 AM Page: 2515 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/19/05ISR Number: 4641224-8Report Type:Direct Company Report #CTU 246587 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Risperdal 2 Mg PS 1//2 TAB AT Hospitalization - Agitation BEDTIME AND Initial or Prolonged Bacteriuria AS NEEDED Blood Creatine Haloperidol 2 Mg SS 2 MG THREEE Phosphokinase Increased TIMES A DAY Body Temperature Aspirin C Increased Atenolol C Hypotension Docusate C Leukocytosis Galantamine C Muscle Rigidity Lisinopril C Neuroleptic Malignant Mvi C Syndrome Valproate C Pain Sepsis Shift To The Left Somnolence Date:04/19/05ISR Number: 4641298-4Report Type:Expedited (15-DaCompany Report #04P-056-0280947-00 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Foreign Norvir Soft Gelatin Initial or Prolonged Health Capsules (Norvir) Professional (Ritonavir) PS ORAL 100 MG, 2 IN Other 1 D, PER ORAL Risperidone SS ORAL PER ORAL Zidovudine SS ORAL PER ORAL Bactrim SS ORAL 1 DOSATE FORMS, 1 IN 1 D, PER ORAL Buprenorphine Hydrochloride SS SUBLINGUAL 4 MG, 1 IN 1 D, SUBLINGUAL Indinavir Sulfate SS ORAL 400 MG, 2 IN 1 D, PER ORAL Fluconazole C Olanzapine C Filgrastim C Kaletra Soft Gelatin Capsules (Kaletra) C Lamivudine C Didanosine C Date:04/20/05ISR Number: 4640238-1Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20050400025 Age:51 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal PS OROPHARINGEAL Dosage Life-Threatening regimen: 3 MGD MG D Citalopram C Stesolid C Hermolepsin Retard C 22-Feb-2006 08:20 AM Page: 2516 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/20/05ISR Number: 4640368-4Report Type:Periodic Company Report #200400706425 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypotrichosis Lithium PS Glaxosmithkline ORAL 600MG Per day 30 YR Risperdal SS ORAL 4MG Per day YR Synthroid C Glaxosmithkline ORAL .125MG Per day Novolog C SUBCUTANEOUS Lantus C SUBCUTANEOUS 15UD Per day Premarin C ORAL .3MG Per day Clonopin C ORAL 2MG Per day Novolin N C SUBCUTANEOUS 5UD Per day Date:04/20/05ISR Number: 4641449-1Report Type:Direct Company Report #CTU 246695 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperidone M Tabs PS ORAL 2MG BID ORAL Phosphokinase Increased Date:04/20/05ISR Number: 4642094-4Report Type:Direct Company Report #CTU 246733 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Haloperidol Initial or Prolonged Neuroleptic Malignant Decanoate PS INTRAMUSCULAR 75 MG IM X 1 Syndrome 1 WEEK Tachypnoea PRIOR TO ADMISSION Risperdal SS ORAL 4MG BID PO 1 WEEK PRIOR TO ADMISSION Date:04/21/05ISR Number: 4641547-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050403185 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Risperdal PS OROPHARINGEAL Congestive Risperdal SS OROPHARINGEAL Pneumonia Pneumonia Aspiration Sick Sinus Syndrome Date:04/21/05ISR Number: 4641548-4Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20050206201 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Risperdal PS Self Injurious Behaviour Methylphenidate C 20 mg at 0700, 15 mg at noon, and 10 mg at 1600 hours. 22-Feb-2006 08:20 AM Page: 2517 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/05ISR Number: 4643310-5Report Type:Expedited (15-DaCompany Report #2005036735 Age:71 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Consumer Zoloft (Sertraline) PS ORAL 200 MG (100 Initial or Prolonged Antipsychotic Drug Level Health MG, 2 TABS IN Other Increased Professional 1 DAY) ORAL Anxiety Risperidone Blood Potassium Decreased (Risperidone) SS ORAL ORAL Dehydration Lansoprazole Depressed Mood (Lansoprazole) C Hernia Repair Tamsulosin Hyperhidrosis Hydrochloride Hypersomnia (Tamsulosin Incoherent Hydrochloride) C Obsessive Thoughts Levothyroxine Sodium Oesophageal Stenosis (Levothyroxine Pain Sodium) C Sleep Disorder Loratadine Tremor (Loratadine) C Weight Decreased Tramadol (Tramadol) C Lorazepam (Lorazepam) C Lithium Carbonate (Lithium Carbonate) C Date:04/22/05ISR Number: 4642656-4Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20050404715 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Status Epilepticus Risperdal PS UNKNOWN Date:04/22/05ISR Number: 4642657-6Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20041202809 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neutropenia Risperdal PS OROPHARINGEAL Other Risperdal Consta SS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Olanzapine SS 8 DAY Chlorpromazine C Date:04/25/05ISR Number: 4643610-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050105533 Age:70 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tachycardia Risperdal Consta PS INTRAMUSCULAR Ventricular Extrasystoles Delix C OROPHARINGEAL Paroxat C OROPHARINGEAL Lopresor C OROPHARINGEAL Date:04/25/05ISR Number: 4643611-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050303448 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Risperdal Consta PS INTRAMUSCULAR Cogentin C UNKNOWN Provigil C UNKNOWN 22-Feb-2006 08:20 AM Page: 2518 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/05ISR Number: 4644598-7Report Type:Direct Company Report #CTU 247038 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Risperdal PS Increased Cardiac Disorder Hypertension Nonspecific Reaction Date:04/26/05ISR Number: 4644536-7Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-04P-056-0280947-00 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Norvir Soft Gelatin Initial or Prolonged Capsules PS ORAL 16 DAY Risperidone SS ORAL Zidovudine SS ORAL 16 DAY Bactrim SS ORAL Buprenorphine Hydrochloride SS SUBLINGUAL Indinavir Sulfate SS ORAL 16 DAY Fluconazole C ORAL Olanzapine C ORAL Filgrastim C 5 DAY Kaletra Soft Gelatin Capsules C ORAL Lamivudine C ORAL Didanosine C ORAL Date:04/26/05ISR Number: 4645129-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050403202 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Risperdal PS OROPHARINGEAL Prolonged Risperdal SS OROPHARINGEAL Depakote C Date:04/26/05ISR Number: 4645130-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050403710 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal Consta PS INTRAMUSCULAR Date:04/26/05ISR Number: 4645131-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050403711 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Risperdal PS OROPHARINGEAL Initial or Prolonged Vocal Cord Paralysis Date:04/26/05ISR Number: 4645132-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050403716 Age:72 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pancreatitis Risperdal Consta PS INTRAMUSCULAR 22-Feb-2006 08:20 AM Page: 2519 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/26/05ISR Number: 4645133-XReport Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050403821 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Amilsupride SS OROPHARINGEAL Date:04/26/05ISR Number: 4645134-1Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050403843 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Olanzapine SS OROPHARINGEAL Date:04/26/05ISR Number: 4645135-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050404056 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Risperdal PS OROPHARINGEAL Eye Haemorrhage Temesta C Date:04/26/05ISR Number: 4645136-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050405079 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coagulopathy Risperdal Consta PS INTRAMUSCULAR Date:04/26/05ISR Number: 4645237-1Report Type:Expedited (15-DaCompany Report #NL-GLAXOSMITHKLINE-B0379014A Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Paroxetine Initial or Prolonged Parkinsonism Hydrochloride PS Glaxosmithkline 2 DAY Risperdal SS UNKNOWN 2MG Per day Temazepam C Alprazolam C .25MG Twice per day Date:04/26/05ISR Number: 4645470-9Report Type:Expedited (15-DaCompany Report #FR-MERCK-0411FRA00103 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Crixivan PS Merck & Co., Inc ORAL 17 DAY Initial or Prolonged Risperidone SS ORAL Zidovudine SS ORAL 17 DAY Buprenorphine Hydrochloride C ORAL Sulfamethoxazole And Trimethoprim C ORAL Ritonavir C ORAL 17 DAY Fluconazole C ORAL 22-Feb-2006 08:20 AM Page: 2520 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/27/05ISR Number: 4646213-5Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20050305716 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Risperidone PS Extrapyramidal Disorder Risperidone SS Leukopenia Risperidone SS Zuclopenthixol C Clozapin C Clozapin C Clozapin C Clozapin C Clozapin C Clozapin C Clozapin C Clozapin C Clozapin C Flupenthixol C Flupenthixol C Flupenthixol C Flupenthixol C Flupenthixol C Fluphenazine C Fluphenazine C Fluphenazine C Fluphenazine C Fluphenazine C Fluphenazine C Fluphenazine C Fluphenazine C Fluphenazine C Fluphenazine C Prazine C Prazine C Prazine C Prazine C Prazine C Lorazepam C Lorazepam C Lorazepam C Lorazepam C Lorazepam C Lorazepam C Lorazepam C Lorazepam C Lorazepam C Date:04/27/05ISR Number: 4646214-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050403660 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Date:04/27/05ISR Number: 4646215-9Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050404025 Age: Gender:Female I/FU:I Outcome PT Other Abortion Spontaneous Drug Exposure During 22-Feb-2006 08:20 AM Page: 2521 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pregnancy Report Source Product Role Manufacturer Route Dose Duration Risperdal Consta PS INTRAMUSCULAR Date:04/27/05ISR Number: 4646216-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050404667 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Risperidone PS OROPHARINGEAL Decreased Celebrex C OROPHARINGEAL White Blood Cell Count Decreased Date:04/27/05ISR Number: 4647584-6Report Type:Direct Company Report #CTU 247210 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Risperidone M Oral Tongue Disorder Disintegrating 2mg PS ORAL 4MG PO QHS Risperidone M Oral Disintegrating 1 & 2 Mg SS ORAL 3MG PO QHS Haloperidol C Lorazepam C Benztropine C Depakene C Hydroxyzine Pamoate C Clozapine C Lamictal C Date:04/27/05ISR Number: 4660837-0Report Type:Periodic Company Report #US-JNJFOC-20040706933 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Grand Mal Convulsion Health Ultram (Tramadol Professional Hydrochloride) Tablets PS ORAL 50 MG, 3 IN 1 DAY, ORAL Risperidone (Risperidone) SS Date:04/28/05ISR Number: 4647460-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050403704 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Risperdal Consta PS INTRAMUSCULAR 2 WK Neutropenia Date:04/28/05ISR Number: 4647461-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050404045 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Meningitis Pneumococcal Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged 22-Feb-2006 08:20 AM Page: 2522 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/28/05ISR Number: 4647463-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041106096 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cortisol Increased Risperdal PS OROPHARINGEAL Hyperprolactinaemia Risperdal SS OROPHARINGEAL Polycystic Ovaries Carbamazepine C Pyridoxine C Zineryt C Zineryt C Dermovate C Lorazepam C 1 -2 mg BID PRN Benefiber C 5 scoops a day Date:04/28/05ISR Number: 4649405-4Report Type:Direct Company Report #CTU 247349 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Galactorrhoea Risperdal PS Date:04/28/05ISR Number: 4650532-6Report Type:Expedited (15-DaCompany Report #2005UW6257 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Dystonia Health Seroquel PS ORAL 600 MG PO Intervention to Professional Seroquel SS ORAL 400 MG PO Prevent Permanent Risperdal SS 6 MG Impairment/Damage Depakote SS Wellbutrin SS Strattera SS Trileptal "Ciba-Geigy" SS Trileptal "Ciba-Geigy" SS DECREASING Date:04/29/05ISR Number: 4649047-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050405319 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Risperdal PS OROPHARINGEAL Initial or Prolonged Other Date:04/29/05ISR Number: 4649048-2Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20050405525 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Leukopenia Risperdal PS OROPHARINGEAL Risperdal Consta SS INTRAMUSCULAR Quetiapine SS OROPHARINGEAL 900 mg/ 2x1 Quetiapine SS OROPHARINGEAL 600 mg /2 x 1 Quetiapine SS OROPHARINGEAL 400 mg /2 X 1 Chlorpromazine SS OROPHARINGEAL 100 mg/ 4 X 1 Biperidene SS OROPHARINGEAL 6 mg/ 3X1 22-Feb-2006 08:20 AM Page: 2523 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/05ISR Number: 4649049-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050405079 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coagulopathy Risperdal Consta PS INTRAMUSCULAR Date:04/29/05ISR Number: 4649050-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050201087 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Risperdal PS OROPHARINGEAL Initial or Prolonged Hyponatraemia Ativan C Polydipsia Rivotril C Polydipsia Psychogenic Date:04/29/05ISR Number: 4649051-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050205999 Age:54 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Risperdal PS OROPHARINGEAL Hospitalization - Medication Error Haloperidol SS INTRAVENOUS Initial or Prolonged Sinus Arrest Midazolam C INTRAVENOUS Date:04/29/05ISR Number: 4649052-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050201334 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal PS OROPHARINGEAL Menstrual Disorder Risperdal SS OROPHARINGEAL White Blood Cell Count Risperdal SS OROPHARINGEAL Decreased Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Lorazepam C OROPHARINGEAL Promethazine Hydrochloride C Date:05/02/05ISR Number: 4650015-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050405087 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Weight Decreased Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Date:05/02/05ISR Number: 4650016-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050405169 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2524 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/05ISR Number: 4650017-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050405622 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aggression Risperdal PS OROPHARINGEAL Other Amnesia Paracetamol I UNKNOWN Disorientation Drug Interaction Date:05/02/05ISR Number: 4650018-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041206697 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Rash With Risperdal PS OROPHARINGEAL Hospitalization - Eosinophilia And Systemic Diamicron SS OROPHARINGEAL Initial or Prolonged Symptoms Depakote SS OROPHARINGEAL 3 cp per day Hepatitis Rivotril SS Hypersensitivity Deroxat C Pancytopenia Xanax C Date:05/02/05ISR Number: 4652842-5Report Type:Expedited (15-DaCompany Report #2005-127760-NL Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Health Mirtazapine PS ORAL 15 MG, ORAL Atrial Fibrillation Professional Risperidone SS ORAL MG, ORAL 144 DAY Blood Pressure Buspirone Fluctuation Hydrochloride SS ORAL 15 MG, ORAL 131 DAY Coma Galantamine SS ORAL MG/24 MG, Heart Rate Irregular ORAL 124 DAY Hemiparesis Valproate Sodium SS ORAL MG, ORAL 127 DAY Hypertension Paragar SS 10 MG 6 MON Salivary Hypersecretion Escitalopram SS 10 MG Date:05/03/05ISR Number: 4651132-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050406219 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal PS OROPHARINGEAL Hepatic Function Abnormal Hypoproteinaemia Date:05/03/05ISR Number: 4651133-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050401789 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Accident Risperdal Consta PS INTRAMUSCULAR Hospitalization - Tinnitus Risperdal Consta SS INTRAMUSCULAR Initial or Prolonged Betahistine C Date:05/03/05ISR Number: 4651134-8Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20030704666 Age: Gender:Female I/FU:I Outcome PT Death Acute Psychosis Acute Respiratory Distress Syndrome 22-Feb-2006 08:20 AM Page: 2525 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotension Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Pneumonia Risperdal PS OROPHARINGEAL Sepsis Largactil SS The dose was Tachycardia reduced on 11-JUL-2003 Risperdal SS OROPHARINGEAL Dolcontin C OROPHARINGEAL Paracet C OROPHARINGEAL Clarityn C OROPHARINGEAL Mycostatin C OROPHARINGEAL Afipran C OROPHARINGEAL Penicillin C INTRAVENOUS Naxogin C OROPHARINGEAL Levaxin C OROPHARINGEAL Entocort C OROPHARINGEAL Somac C OROPHARINGEAL Vioxx C OROPHARINGEAL Cisplatin C PARENTERAL Sobril C OROPHARINGEAL Selexid C OROPHARINGEAL Date:05/03/05ISR Number: 4651135-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050403704 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Risperdal Consta PS INTRAMUSCULAR 2 WK Neutropenia Risperidone C Date:05/03/05ISR Number: 4651136-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041003910 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Aminotransferase Risperdal Consta SS INTRAMUSCULAR Other Increased Temesta C Blood Creatine Akineton Retard C Phosphokinase Increased Mopral C Blood Creatinine Tegretol C Increased Sulfarlem C Grand Mal Convulsion Iatrogenic Injury Myoglobin Blood Increased Red Blood Cell Sedimentation Rate Increased Date:05/03/05ISR Number: 4651137-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050106806 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Abnormal Dreams Initial or Prolonged Amnesia Confusional State Dehydration Drug Interaction Malaise 22-Feb-2006 08:20 AM Page: 2526 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Myocardial Infarction Nasopharyngitis Nightmare Report Source Product Role Manufacturer Route Dose Duration Pneumonia Risperdal PS OROPHARINGEAL Therapeutic Agent Risperdal SS OROPHARINGEAL Toxicity Lithium SS OROPHARINGEAL Tremor Lithium SS OROPHARINGEAL Urinary Tract Infection Risperdal SS OROPHARINGEAL one dose Klonapin C OROPHARINGEAL Effexor Xl C Topamax C Date:05/03/05ISR Number: 4653161-3Report Type:Direct Company Report #CTU 247674 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Resperdal PS 3MG DAILY Mellaril SS Date:05/03/05ISR Number: 4653162-5Report Type:Direct Company Report #CTU 247671 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Resperdal PS Mellaril SS Date:05/03/05ISR Number: 4654601-6Report Type:Direct Company Report #CTU 247607 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Painful Erection Risperidone 4 Mg Janssen PS Janssen ORAL 4 MG QHS ORAL Risperidone Consta 25 Mg Janssen SS Janssen INTRAMUSCULAR 25 MG Q2 WEEKS INTRAMUSCU Multivitamin C Lorazepam C Haloperidol C Date:05/03/05ISR Number: 4654672-7Report Type:Direct Company Report #CTU 247676 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Resperdal PS MANY YEARS Mellaril SS Date:05/03/05ISR Number: 4654677-6Report Type:Direct Company Report #CTU 247672 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intracardiac Thrombus Resperdal PS FOR YEARS Mellaril SS 22-Feb-2006 08:20 AM Page: 2527 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/03/05ISR Number: 4654678-8Report Type:Direct Company Report #CTU 247673 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Resperdal PS Mellaril SS Date:05/04/05ISR Number: 4652117-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050405675 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erythema Multiforme Risperdal PS dose taken at Initial or Prolonged Neuroleptic Malignant night Syndrome Risperdal SS dose taken at night Divalproex SS dose taken at night Risperdal SS dose taken at night Quetiapine C Quetiapine C dose taken at night Date:05/04/05ISR Number: 4652586-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050405182 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Risperdal PS OROPHARINGEAL Date:05/04/05ISR Number: 4652587-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050405498 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Risperdal PS OROPHARINGEAL Date:05/04/05ISR Number: 4652588-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20041007637 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS OROPHARINGEAL 1.5MG 21 DAY Risperdal SS OROPHARINGEAL 21 DAY Clozapine SS OROPHARINGEAL Ranitidine SS Gabapentin SS OROPHARINGEAL Lamotrigine SS OROPHARINGEAL Lamotrigine SS OROPHARINGEAL Date:05/04/05ISR Number: 4652589-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050406192 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Breast Cancer Risperdal PS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2528 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/04/05ISR Number: 4652590-1Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20040909781 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholelithiasis Risperdal Consta PS INTRAMUSCULAR Liver Function Test Risperdal Consta SS INTRAMUSCULAR Abnormal Risperdal Consta SS INTRAMUSCULAR Risperdal C OROPHARINGEAL Nocte Risperdal C OROPHARINGEAL Nocte Risperdal C OROPHARINGEAL Nocte Motilium C Zoton C Mane Eltroxin C Date:05/04/05ISR Number: 4652591-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050406902 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Torsade De Pointes Risperidone PS OROPHARINGEAL 9 DAY Haloperidol SS Date:05/04/05ISR Number: 4652593-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050500058 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperdal PS OROPHARINGEAL Initial or Prolonged Delusion Risperdal Consta SS INTRAMUSCULAR Musculoskeletal Stiffness Date:05/04/05ISR Number: 4652594-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041106871 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Risperdal PS OROPHARINGEAL Haemoglobin Decreased Risperdal SS OROPHARINGEAL Hyperglycaemia Oren-Gedoku-To C OROPHARINGEAL Red Blood Cell Count Oren-Gedoku-To C OROPHARINGEAL Decreased Oren-Gedoku-To C OROPHARINGEAL White Blood Cell Count Estazolam C OROPHARINGEAL Decreased Flurazepam Hydrochloride C OROPHARINGEAL Promethazine Hydrochloride C OROPHARINGEAL Trihexyphenidyl Hydrochloride C OROPHARINGEAL Ecabet Sodium C OROPHARINGEAL Rilmazafone Hydrochloride C OROPHARINGEAL Date:05/04/05ISR Number: 4654125-6Report Type:Expedited (15-DaCompany Report #2005042029 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Foreign Gabapentin Health (Gabapentin) PS ORAL 100 MG (100 Professional MG, 1 IN 1 D), ORAL Clozapine 22-Feb-2006 08:20 AM Page: 2529 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clozapine) SS ORAL ORAL Ranitidine Hydrochloride (Ranitidine Hydrochloride) SS 150 MG (150 MG, 1 IN 1 D) Risperidone (Risperidone) SS ORAL 100 MG (100 MG, 1 IN 1 D), ORAL Lamotrigine (Lamotrigine) SS ORAL 50 MG (50 MG, 1 IN 1 D), ORAL Date:05/04/05ISR Number: 4654902-1Report Type:Expedited (15-DaCompany Report #DEWYE477604MAR05 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Study Trevilor Initial or Prolonged Increased (Venlafaxine Aspartate Hydrochloride, Aminotransferase Tablet) PS ORAL SEE IMAGE 10 DAY Increased Risperdal Blood Alkaline (Risperidone, , 0) SS ORAL SEE IMAGE 14 DAY Phosphatase Increased Tavor (Lorazepam) C Drug Interaction Drug Level Increased Gamma-Glutamyltransferase Increased Date:05/05/05ISR Number: 4653423-XReport Type:Expedited (15-DaCompany Report #GB-GLAXOSMITHKLINE-B0379106A Age:13 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Aggression Paracetamol PS Glaxosmithkline UNKNOWN Other Disorientation Risperidone SS UNKNOWN Drug Interaction Date:05/05/05ISR Number: 4653440-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050405650 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal Consta PS INTRAMUSCULAR Risperdal SS OROPHARINGEAL Date:05/05/05ISR Number: 4653441-1Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20050404715 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Status Epilepticus Risperdal PS UNKNOWN Risperdal SS UNKNOWN Paxil C Paxil C 22-Feb-2006 08:20 AM Page: 2530 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/05ISR Number: 4653729-4Report Type:Expedited (15-DaCompany Report #CH-BRISTOL-MYERS SQUIBB COMPANY-12951091 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Buspar Tabs PS Bristol-Myers Squibb Other Blood Pressure Increased Company ORAL Coma Risperdal SS ORAL Dose Value: Death 1.5 mg-2.5 mg Postictal State Reminyl SS ORAL Dose value: Salivary Hypersecretion 8 mg-26 mg and 24 mg Convulex SS ORAL Dose value: 100 mg-200 mg Remeron SS ORAL Paragar SS Date:05/06/05ISR Number: 4654537-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050406296 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sudden Hearing Loss Risperdal PS OROPHARINGEAL Date:05/06/05ISR Number: 4654538-2Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20050406345 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Risperdal Consta PS INTRAMUSCULAR Sedation Risperdal Consta SS INTRAMUSCULAR Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Date:05/06/05ISR Number: 4655266-XReport Type:Periodic Company Report #DE-JNJFOC-20050202918 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Risperdal PS OROPHARINGEAL Reminyl C OROPHARINGEAL Patient has been taking reminyl for 3 and half years. Date:05/06/05ISR Number: 4655267-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050303344 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Conversion Disorder Risperdal PS OROPHARINGEAL Initial or Prolonged Convulsion Hyponatraemia Locked-In Syndrome Polydipsia 22-Feb-2006 08:20 AM Page: 2531 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/05ISR Number: 4655913-2Report Type:Direct Company Report #CTU 247977 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Risperdal Consta 25mg/2cc Janssen PS Janssen INTRAMUSCULAR 25MG Q 2WKS INTRAMUSCULAR Paroxetine 40mg Generic SS ORAL 40MG 1 HS ORAL Depakote C Benztropine C Date:05/09/05ISR Number: 4656119-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050500706 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nail Discolouration Risperdal PS UNKNOWN Nail Disorder Date:05/09/05ISR Number: 4656120-XReport Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050307177 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Autoimmune Hepatitis Risperdal PS OROPHARINGEAL Initial or Prolonged Hepatitis Cholestatic Orap SS OROPHARINGEAL Fluoxetine C UNKNOWN Carbamazepine C UNKNOWN Date:05/09/05ISR Number: 4659047-2Report Type:Expedited (15-DaCompany Report #A0363979A Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Health Paxil (Paroxetine Abnormal Dreams Professional Hydrochloride) PS ORAL SEE DOSAGE Aggression Other TEXT/ORAL Anger Risperidone Delusion (Risperidone) SS Drug Withdrawal Syndrome Mental Impairment Murder Oppositional Defiant Disorder Poisoning Stress Date:05/10/05ISR Number: 4657460-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050500070 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Risperdal PS 7 YR Other Insulin-Dependent Pain 22-Feb-2006 08:20 AM Page: 2532 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/10/05ISR Number: 4657461-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050500365 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Date:05/10/05ISR Number: 4658430-9Report Type:Direct Company Report #CTU 248118 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oral Intake Reduced Risperdal PS Depakote C Feosol C Abilify C Asa C Clarinex C Colac C Dilantin C Haldol C K-Dur C Synthroid C Date:05/10/05ISR Number: 4658676-XReport Type:Direct Company Report #CTU 248120 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gynaecomastia Risperdal 1mg PS ORAL 1 MG BID ORAL Amantadine C Tamsulosin C Trazodone C Aspirin C Hydrocortisone Suppositories C Atenolol C Date:05/11/05ISR Number: 4658810-1Report Type:Expedited (15-DaCompany Report #FR-ROCHE-403649 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dermatitis Exfoliative Rivotril PS Roche ORAL Drug Rash With Depakote SS ORAL 40 DAY Eosinophilia And Systemic Risperdal SS ORAL 42 DAY Symptoms Diamicron SS ORAL 19 DAY Eosinophilia Face Oedema Hepatitis Hypersensitivity Pyrexia Date:05/11/05ISR Number: 4658897-6Report Type:Periodic Company Report #FR-JNJFOC-20050403660 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Athymil C 22-Feb-2006 08:20 AM Page: 2533 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/05ISR Number: 4658898-8Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20050501114 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Risperdal PS OROPHARINGEAL 1.5 - 2.5 mg Atrial Fibrillation Buspar SS OROPHARINGEAL Blood Pressure Reminyl SS OROPHARINGEAL Fluctuation Reminyl SS OROPHARINGEAL 8-16 mg Cerebrovascular Accident Convulex SS OROPHARINGEAL 100-200 mg Coma Remeron SS OROPHARINGEAL Depression Remeron SS OROPHARINGEAL Hemiparesis Cipralex SS OROPHARINGEAL Salivary Hypersecretion Paragar SS OROPHARINGEAL Sleep Disorder Paragar SS OROPHARINGEAL Paragar SS OROPHARINGEAL Date:05/11/05ISR Number: 4659220-3Report Type:Expedited (15-DaCompany Report #2005AP02539 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Seroquel PS Zeneca Multiple Drug Overdose Pharmaceutical ORAL Suicide Attempt Seroquel SS Zeneca Pharmaceutical ORAL PATIENT PROBABLY TOOK A MONTH'S SUPPLY OF QUETIAPINE Risperdal SS ORAL Risperdal SS ORAL PATIENT PROBABLY TOOK A MONTH'S SUPPLY OF RISPERIDONE Date:05/12/05ISR Number: 4660384-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050301460 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Affect Lability Risperdal PS OROPHARINGEAL 2-5 mg Initial or Prolonged Drug Interaction Risperdal SS OROPHARINGEAL Drug Level Decreased Risperdal SS OROPHARINGEAL Drug Level Increased Risperdal SS OROPHARINGEAL Galactorrhoea Timonil C OROPHARINGEAL Zoloft I OROPHARINGEAL Date:05/12/05ISR Number: 4660385-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050301470 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal PS OROPHARINGEAL Initial or Prolonged Hepatic Steatosis Risperdal SS OROPHARINGEAL Liver Function Test Tavor C OROPHARINGEAL 1 - 1.5 mg Abnormal Tavor C OROPHARINGEAL 1.5 - 2 mg Tavor C OROPHARINGEAL Tavor C OROPHARINGEAL Tavor C OROPHARINGEAL Trevilor I OROPHARINGEAL Trevilor I OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2534 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trevilor I OROPHARINGEAL Date:05/12/05ISR Number: 4660482-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050500027 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Congenital Anomaly Haloperidol PS taken during Other Drug Exposure During third Pregnancy trimester of Gastroschisis pregnancy Risperidone SS TRANSPLACENTAL taken during third trimester of pregnancy Date:05/13/05ISR Number: 4661163-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050500922 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Adenocarcinoma Risperdal PS UNKNOWN Date:05/13/05ISR Number: 4661164-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050502615 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Risperdal PS OROPHARINGEAL Disseminated Impromen SS OROPHARINGEAL Intravascular Coagulation Haldol SS OROPHARINGEAL Polydipsia Chloropromazine SS OROPHARINGEAL Systemic Inflammatory Levopromazine C OROPHARINGEAL Response Syndrome Biperiden Water Intoxication Hydrochloride C OROPHARINGEAL Promethazine Hydrochloride C OROPHARINGEAL Etizolam C Cloxazolam C Haloxazolam C Flunitrazepam C Date:05/13/05ISR Number: 4661262-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050301645 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Risperdal Consta PS INTRAMUSCULAR Cardiac Arrest Risperdal Consta SS INTRAMUSCULAR Coma Neurocil SS OROPHARINGEAL Drug Interaction Neurocil SS OROPHARINGEAL Hypoxic Encephalopathy Neurocil SS OROPHARINGEAL Pulmonary Embolism Risperdal C OROPHARINGEAL Respiratory Arrest Akineton C Tavor C Tavor C Tavor C Leponex I OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2535 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/13/05ISR Number: 4661398-2Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0363979A Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Paxil PS Glaxosmithkline ORAL Anger Risperdal SS Delusion Disinhibition Drug Withdrawal Syndrome Murder Negativism Date:05/13/05ISR Number: 4661534-8Report Type:Periodic Company Report #ES-JNJFOC-20050403843 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Olanzapine SS OROPHARINGEAL Date:05/13/05ISR Number: 4661535-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050302736 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Influenza Like Illness Risperdal Consta PS INTRAMUSCULAR Leukopenia Cogentin C Rash Date:05/13/05ISR Number: 4662497-1Report Type:Direct Company Report #CTU 248490 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Risperdol 2 Mg. PS ORAL 2 MG. Intervention to Non-Insulin-Dependent B.I.D. ORAL Prevent Permanent Wellbutrin SS Impairment/Damage Depakote C Adderal C Paxil C Date:05/16/05ISR Number: 4661952-8Report Type:Expedited (15-DaCompany Report #FR-RB-1173-2004 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysthymic Disorder Buprenorphine Initial or Prolonged Encephalitis Viral Hydrochloride PS SUBLINGUAL Pancytopenia Bactrim SS ORAL Risperidone SS ORAL UNKNOWN Zidovudine SS ORAL UNKNOWN Indinavir Sulfate SS ORAL Ritonavir SS ORAL Fluconazole C UNKNOWN UNKNOWN Date:05/16/05ISR Number: 4662274-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050500399 Age:50 YR Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Blood Cortisol Decreased 22-Feb-2006 08:20 AM Page: 2536 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Constipation Dry Mouth Hyponatraemia Report Source Product Role Manufacturer Route Dose Duration Inappropriate Risperdal PS OROPHARINGEAL Antidiuretic Hormone Mepronizine SS OROPHARINGEAL Secretion Mepronizine SS OROPHARINGEAL 1 cp per day Locked-In Syndrome Nozinan SS OROPHARINGEAL Polydipsia Xanax C 3 tabs/ day Water Intoxication Coversyl C Fludex C Date:05/16/05ISR Number: 4662275-3Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050500650 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS Date:05/16/05ISR Number: 4662276-5Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20050501702 Age:28 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Brucellosis Risperdal PS Initial or Prolonged Congestive Cardiomyopathy Other Date:05/16/05ISR Number: 4662277-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050501748 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatitis B Risperdal Consta PS INTRAMUSCULAR Hepatitis C Date:05/16/05ISR Number: 4662278-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050501750 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Risperdal Consta PS INTRAMUSCULAR Prolonged Date:05/16/05ISR Number: 4664800-5Report Type:Expedited (15-DaCompany Report #DSA_26367_2005 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Intentional Misuse Foreign Tavor PS Initial or Prolonged Salivary Hypersecretion Health Risperdal SS Somnolence Professional Taxilan SS Other Date:05/17/05ISR Number: 4663483-8Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20050305704 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperidone PS OROPHARINGEAL Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2537 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL Risperidone SS OROPHARINGEAL Clozapin C Clozapin C Promazine C Lorazepam C Lorazepam C Lorazepam C Lorazepam C Lorazepam C Lorazepam C Flurazepam C Flurazepam C Flurazepam C Trihexyphenidyl C Mianserin C Mianserin C Mianserin C Lorazepam C Lorazepam C Flurazepam C Flurazepam C Flurazepam C Flurazepam C Date:05/17/05ISR Number: 4663484-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050502386 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sick Sinus Syndrome Risperdal Consta PS INTRAMUSCULAR Date:05/17/05ISR Number: 4663485-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050406296 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Sudden Hearing Loss Risperdal PS OROPHARINGEAL Date:05/17/05ISR Number: 4665298-3Report Type:Expedited (15-DaCompany Report #2004106748 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Neurontin (Tablets) Initial or Prolonged Agitation (Gabapentin) PS 600 MG (300 Other Condition Aggravated MG, 2 IN 1 D) Delusion Haldol (Haloperidol) SS Depression Risperidone Drug Ineffective (Risperidone) SS 6 MG (3 MG, 2 Homicidal Ideation IN 1 D) Intentional Misuse Metformin Multiple Drug Overdose (Metformin) C Psychotic Disorder Suicide Attempt Treatment Noncompliance 22-Feb-2006 08:20 AM Page: 2538 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/05ISR Number: 4665402-7Report Type:Direct Company Report #CTU 248952 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Risperdal 1 Mg Initial or Prolonged Blood Pressure Decreased Janssen PS Janssen ORAL 1 MG ONCE Cerebrovascular Accident DAILY ORAL Dizziness Parkinsonism Date:05/18/05ISR Number: 4664451-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050501737 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gait Disturbance Risperdal PS OROPHARINGEAL Paralysis Glipizide C OROPHARINGEAL Date:05/18/05ISR Number: 4664452-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050502966 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Patent Ductus Arteriosus Risperdal PS Other Pneumothorax Risperdal SS Date:05/18/05ISR Number: 4664453-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050204573 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Risperdal PS OROPHARINGEAL White Blood Cell Count Risperdal SS OROPHARINGEAL Decreased Risperdal SS OROPHARINGEAL Paxil C Nortriptyline C Wellbutrin Sr C Date:05/18/05ISR Number: 4664609-2Report Type:Expedited (15-DaCompany Report #ES-GLAXOSMITHKLINE-B0381370A Age:88 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebral Ischaemia Seroxat PS Glaxosmithkline ORAL Coma Risperidone SS ORAL 2MG Twice per day 10 DAY Distraneurine C ORAL 30 DAY Fenitoin C ORAL Clopidogrel C ORAL Glibenclamide C ORAL Clobazam C ORAL Pentoxyfylline C ORAL Letrozole C ORAL Enalapril C ORAL Furosemide C Glaxosmithkline ORAL 22-Feb-2006 08:20 AM Page: 2539 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/18/05ISR Number: 4666271-1Report Type:Direct Company Report #CTU 249051 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Anorexia Risperdal PS 1 DAILY 3 YR Aphasia Baby Aspirin C Lower Gastrointestinal Haemorrhage Transient Ischaemic Attack Date:05/18/05ISR Number: 4666462-XReport Type:Expedited (15-DaCompany Report #2005059691 Age:44 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Buttock Pain Health Celebrex (Celecoxib) PS ORAL 200 MG (100 Initial or Prolonged Delusion Professional MG, PRN), Other Leukopenia ORAL Pain In Extremity Risperidone Paranoia (Risperidone) SS Diphenhydramine (Diphenhydramine) C Paracetamol (Paracetamol) C Date:05/19/05ISR Number: 4665583-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050502390 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Pregnancy Other Monoplegia Pulmonary Embolism Date:05/19/05ISR Number: 4665584-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040704586 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Risperdal PS OROPHARINGEAL Anaemia Risperdal SS OROPHARINGEAL Blood Amylase Increased Risperdal SS OROPHARINGEAL Blood Triglycerides Risperdal SS OROPHARINGEAL Increased Risperdal SS OROPHARINGEAL Hyperlipidaemia Risperdal SS OROPHARINGEAL Restlessness Risperdal SS OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2540 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Biperiden Hydrochloride C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Diazepam C OROPHARINGEAL Propranolol Hydrochloride C OROPHARINGEAL Tandospirone Citrate C OROPHARINGEAL Tandospirone Citrate C OROPHARINGEAL Date:05/19/05ISR Number: 4665585-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050406902 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Administration Error Risperidone PS OROPHARINGEAL 9 DAY Drug Interaction Soybean Oil C INTRAVENOUS Restlessness Furosemide C INTRAVENOUS Torsade De Pointes Famotidine C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Proteamin C INTRAVENOUS Tazobactam C INTRAVENOUS Ciprofloxacin C INTRAVENOUS Aminophyline C INTRAVENOUS Proteamin C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Haloperidol I INTRAVENOUS Haloperidol I INTRAVENOUS Date:05/19/05ISR Number: 4666141-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050501814 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Risperdal PS OROPHARINGEAL Initial or Prolonged Drug Withdrawal Syndrome Haldol SS UNKNOWN Other Extrapyramidal Disorder Gastroenteritis General Physical Health Deterioration Date:05/19/05ISR Number: 4666142-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050405169 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Infection Risperdal PS OROPHARINGEAL Leukopenia Risperdal SS OROPHARINGEAL Seroquel C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2541 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/05ISR Number: 4666143-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050403704 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Risperdal Consta PS INTRAMUSCULAR 2 WK Neutropenia Risperidone C Date:05/19/05ISR Number: 4666491-6Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-04P-056-0280947-00 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Norvir Soft Gelatin Initial or Prolonged Capsules PS ORAL 16 DAY Risperidone SS ORAL Zidovudine SS ORAL 16 DAY Bactrim SS ORAL Buprenorphine Hydrochloride SS SUBLINGUAL Indinavir Sulfate SS ORAL 16 DAY Fluconazole C ORAL Olanzapine C ORAL Filgrastim C 5 DAY Kaletra Soft Gelatin Capsules C ORAL Lamivudine C ORAL Didanosine C ORAL Date:05/20/05ISR Number: 4667268-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050502615 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Risperdal PS OROPHARINGEAL Hospitalization - Depressed Level Of Impromen SS OROPHARINGEAL Initial or Prolonged Consciousness Haldol SS OROPHARINGEAL Other Disseminated Chloropromazine SS OROPHARINGEAL Intravascular Coagulation Levopromazine C OROPHARINGEAL Electroencephalogram Biperiden Abnormal Hydrochloride C OROPHARINGEAL Fibrin Degradation Promethazine Products Increased Hydrochloride C OROPHARINGEAL Hyponatraemia Etizolam C Polydipsia Cloxazolam C Prothrombin Time Haloxazolam C Prolonged Flunitrazepam C Psychomotor Hyperactivity Pyrexia Self Injurious Behaviour Systemic Inflammatory Response Syndrome Systolic Hypertension Tachycardia Thrombocytopenia Water Intoxication 22-Feb-2006 08:20 AM Page: 2542 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/20/05ISR Number: 4667682-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050406219 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal PS OROPHARINGEAL Gastric Ulcer Hepatic Function Abnormal Hypoproteinaemia Date:05/23/05ISR Number: 4668952-2Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0559419A Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Paxil PS Glaxosmithkline UNKNOWN Initial or Prolonged Agitation Zoloft SS ORAL 25MG Unknown Other Anxiety Risperdal SS UNKNOWN Insomnia Murder Personality Change Psychomotor Hyperactivity School Refusal Suicidal Ideation Date:05/23/05ISR Number: 4669009-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050504246 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cyanosis Risperdal PS OROPHARINGEAL Ventricular Extrasystoles Carbamazepine SS OROPHARINGEAL Carbamazepine SS OROPHARINGEAL Haloperidol C Date:05/23/05ISR Number: 4669561-1Report Type:Expedited (15-DaCompany Report #PHBS2005CH07189 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Ophthalmoplegia Leponex PS Novartis Sector: Initial or Prolonged Psychotic Disorder Pharma ORAL 600 mg/d Risperdal SS ORAL 4 mg/d Nozinan SS ORAL 125 mg/d Date:05/23/05ISR Number: 4673209-XReport Type:Direct Company Report #CTU 249243 Age:97 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Risperidone PS Paroxetine C Zolpidem Tartrate C Acetaminophen C Lubricating (Pf) Oph Oint C Sodium Chloride C Capsaicin C Vitamin E C Ascorbic Acid C Nitroglycerin C Aloh/Mgoh/Simth Xtra Strength Liq Susp C 22-Feb-2006 08:20 AM Page: 2543 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Milk Of Magnesia C Hypromellose C Eucerin C Senna Conc C Omeprazole C Furosemide C Atenolol C Aspirin E.C. C Date:05/23/05ISR Number: 4673219-2Report Type:Direct Company Report #CTU 249230 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Pharmaceutical Product Fluoxetine PS Complaint Risperdal SS Amiloride SS Hctz SS Date:05/24/05ISR Number: 4672720-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050405482 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Blood Creatine Risperdal SS OROPHARINGEAL Other Phosphokinase Increased Chest Pain Electrocardiogram Change Electrocardiogram Qt Corrected Interval Prolonged Helicobacter Gastritis Palpitations Ventricular Hypokinesia Date:05/24/05ISR Number: 4674103-0Report Type:Direct Company Report #CTU 249389 Age:61 YR Gender:Male I/FU:I Outcome PT Required Agitation Intervention to Autonomic Nervous System Prevent Permanent Imbalance Impairment/Damage Bradycardia Confusional State Decreased Appetite Diarrhoea Dyskinesia Dystonia Faeces Discoloured Fatigue Heart Rate Increased Hypernatraemia Memory Impairment Mental Status Changes Nephrogenic Diabetes Insipidus Tardive Dyskinesia Therapeutic Agent Toxicity 22-Feb-2006 08:20 AM Page: 2544 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tremor Verbigeration Report Source Product Role Manufacturer Route Dose Duration Lithium PS Haldoperidol SS Lisinopril SS Risperidone SS Date:05/24/05ISR Number: 4674499-XReport Type:Direct Company Report #CTU 249447 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Suicide Attempt Risperdal PS Hospitalization - Initial or Prolonged Disability Other Required Intervention to Prevent Permanent Impairment/Damage Date:05/24/05ISR Number: 4695580-5Report Type:Expedited (15-DaCompany Report #2005AC00729 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypokalaemia Quetiapine PS Zeneca Initial or Prolonged Intentional Misuse Pharmaceutical ORAL Overdose Quetiapine SS Zeneca Suicide Attempt Pharmaceutical ORAL Risperidone SS Risperidone SS BETWEEN 90 MG TO 120 MG Lithium Carbonate C Date:05/25/05ISR Number: 4673119-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050503019 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperdal Consta PS INTRAMUSCULAR 85 DAY Initial or Prolonged Psychotic Disorder Date:05/25/05ISR Number: 4673120-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050503672 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Risperdal PS OROPHARINGEAL Extrapyramidal Disorder Risperdal SS OROPHARINGEAL Parkinson'S Disease Remergil C OROPHARINGEAL Nortrilen C OROPHARINGEAL Nortrilen C OROPHARINGEAL Tavor C OROPHARINGEAL Hypnorex I OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2545 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/25/05ISR Number: 4673121-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050504633 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Thrombosis Risperdal Consta PS INTRAMUSCULAR Date:05/26/05ISR Number: 4674251-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20041103983 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Risperdal PS OROPHARINGEAL Initial or Prolonged Retrovir SS OROPHARINGEAL Other Norvir SS OROPHARINGEAL Bactrim SS OROPHARINGEAL Bactrim SS OROPHARINGEAL Subutex SS OROPHARINGEAL Crixivan SS OROPHARINGEAL Triflucan C Date:05/26/05ISR Number: 4674339-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050503542 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiopulmonary Failure Risperdal Consta PS INTRAMUSCULAR Drug Interaction Risperdal Consta SS INTRAMUSCULAR Psychomotor Hyperactivity Risperdal Consta SS INTRAMUSCULAR Neurotrat C UNKNOWN Neurotrat C UNKNOWN Neurotrat C UNKNOWN Neurotrat C UNKNOWN thiamine nitrate 100mg; pyridoxine HCl 100mg Akineton C UNKNOWN Risperdal I OROPHARINGEAL Neurocil I OROPHARINGEAL Tavor I OROPHARINGEAL Concor I OROPHARINGEAL Vesdil I OROPHARINGEAL Date:05/26/05ISR Number: 4677498-7Report Type:Direct Company Report #CTU 249639 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Sedation Risperidone 1mg Hs & Intervention to 5mg Bid Janssen PS Janssen ORAL 1MG HS / .5MG Prevent Permanent BID PO Impairment/Damage Risperidone 1mg Hs & 5mg Bid Janssen SS Date:05/26/05ISR Number: 4677595-6Report Type:Direct Company Report #CTU 249592 Age:81 YR Gender:Female I/FU:I Outcome Death Life-Threatening Hospitalization - 22-Feb-2006 08:20 AM Page: 2546 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Agitation Zoloft PS 3 X WEEK Anorexia Resperdal SS 3 DAYS Interferon 2a Iv SS INTRAVENOUS Date:05/26/05ISR Number: 4681984-3Report Type:Periodic Company Report #US-JNJFOC-20050307530 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Consumer Risperdal Consta Grimacing (Risperidone) Weight Increased Microspheres PS INTRAMUSCULAR 25 MG, IN 2 WEEK, INTRAMUSCULAR ; 37.5 MG, IN 2 WEEK, Risperdal (Risperidone) Tablets SS ORAL ORAL Seroquel (Quetiapine Fumarate) Tablets C Date:05/26/05ISR Number: 4681985-5Report Type:Periodic Company Report #US-JNJFOC-20050304751 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Consumer Risperdal Consta (Risperidone) Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 WEEK, INTRAMUSCULAR Depakote (Valproate Semisodium) SS Date:05/26/05ISR Number: 4681986-7Report Type:Periodic Company Report #US-JNJFOC-20050304546 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Risperdal Consta Dizziness Professional (Risperidone) Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRA-MUSCULA R; 25 MG, 1 IN 2 WEEK, Risperdal (Risperidone) Tablets SS ORAL 6 MG, IN 1 DAY, ORAL Cogentin Benzatropine Mesilate C 22-Feb-2006 08:20 AM Page: 2547 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/05ISR Number: 4681987-9Report Type:Periodic Company Report #US-JNJFOC-20050303759 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Priapism Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:05/26/05ISR Number: 4681988-0Report Type:Periodic Company Report #US-JNJFOC-20050303460 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chest Pain Health Risperdal Consta Electrocardiogram St-T Professional (Risperidone) Change Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Hypoaesthesia WEEK, Paraesthesia INTRA-MUSCULA R Date:05/26/05ISR Number: 4681989-2Report Type:Periodic Company Report #US-JNJFOC-20050200959 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Risperdal Consta Initial or Prolonged Rash Generalised Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperidone (Tablets) Risperidone C Date:05/26/05ISR Number: 4681990-9Report Type:Periodic Company Report #US-JNJFOC-20050200970 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Peripheral Coldness Consumer Risperdal Consta Initial or Prolonged Schizophrenia, Paranoid (Risperidone) Type Microshperes PS INTRAMUSCULAR SEE IMAGE Risperdal (Risperidone) Tablets SS ORAL 2 MG, 1 IN 1 DAY, ORAL Date:05/26/05ISR Number: 4681991-0Report Type:Periodic Company Report #US-JNJFOC-20050106582 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Consumer Risperdal Consta Increased (Risperidone) Blood Triglycerides Microspheres PS INTRAMUSCULAR 25 MG, Increased INTRAMUSCULAR Diabetes Mellitus Colace ( ) Docusate Sodium C 22-Feb-2006 08:20 AM Page: 2548 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamin C ( ) Ascorbic Acid C Propanolol ( ) Propranolol C Levoxyl (Levothyroxine Sodium) Tablets C Trazodone (Trazodone) Tablets C Abilify (Aripiprazole) C Date:05/26/05ISR Number: 4681993-4Report Type:Periodic Company Report #US-JNJFOC-20041001512 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Risperdal Consta Initial or Prolonged Schizophrenia Professional (Risperidone) Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRAMUSCULAR ; 50 MG, INTRAMUSCULAR Risperdal (Risperidone) Tablets SS 8 MG, 1 IN 1 DAY Geodon (Ziprasidone Hydrochloride) Tablets C Xanax (Alprazolam) C Date:05/26/05ISR Number: 4681996-XReport Type:Periodic Company Report #US-JNJFOC-20041106700 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Risperdal Consta Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRAMUSCULAR Risperidone (Risperidone) Unspecified SS Benztropine (Benzatropine Mesilate) C Metoprolol (Metoprolol) C Hydrochlorothiazide (Hydrochlorothiazide ) C Fluoxetine (Fluoxetine) C 22-Feb-2006 08:20 AM Page: 2549 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/05ISR Number: 4681999-5Report Type:Periodic Company Report #US-JNJFOC-20050302736 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Health Risperdal Consta Rash Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:05/26/05ISR Number: 4682037-0Report Type:Periodic Company Report #US-JNJFOC-20050300351 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aphasia Health Risperdal Consta Foaming At Mouth Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR SEE IMAGE Representative Date:05/26/05ISR Number: 4682039-4Report Type:Periodic Company Report #US-JNJFOC-20050206536 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Consumer Risperdal Consta Initial or Prolonged Fatigue (Risperidone) Nervousness Microspheres PS INTRAMUSCULAR SEE IMAGE Schizophrenia Seroquel (Quetiapine Fumarate) C Lamictal (Lamotrigine) C Date:05/26/05ISR Number: 4682041-2Report Type:Periodic Company Report #US-JNJFOC-20050204994 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Consumer Risperdal Consta Asthma (Risperidone) Convulsion Microspheres PS INTRAMUSCULAR SEE IMAGE Depression Dopamet (Methyldopa) C Diplopia Trileptol Dyspnoea (Oxcarbazepine) C Gastrooesophageal Reflux Keppra Disease (Levetiracetam) C Nausea Lamictal Tremor (Lamotrigine) C Vomiting Lortab (Vicodin) C Weight Increased Tramadol (Tramadol) C Foltx (All Other Therapeutic Products) C Lodine (Etodolac) C Axid (Nizatidine) C Humibid (Guaifenesin) C Qvar (Beclomethasone Dipropionate) C Nasacort (Triamcinolone 22-Feb-2006 08:20 AM Page: 2550 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Acetonide) C Ativan (Lorazepam) C Benadryl (Diphenhydramine Hydrochloride) C Claritin (Loratadine) C Date:05/26/05ISR Number: 4682045-XReport Type:Periodic Company Report #US-JNJFOC-20050205211 Age:69 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Risperdal Consta Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR SEE IMAGE Representative Date:05/26/05ISR Number: 4682046-1Report Type:Periodic Company Report #US-JNJFOC-20050203172 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Health Risperdal Consta Syndrome Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR INTRA-MUSCULA Representative R Date:05/26/05ISR Number: 4682047-3Report Type:Periodic Company Report #US-JNJFOC-20050203274 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Microspheres PS INTRAMUSCULAR SEE IMAGE Zoloft (Sertraline Hydrochloride) C Artane (Trihexyphenidyl Hydrochloride) C Date:05/26/05ISR Number: 4682048-5Report Type:Periodic Company Report #US-JNJFOC-20050203891 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal Consta Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Representative WEEK, INTRA-MUSCULA R Date:05/26/05ISR Number: 4682060-6Report Type:Periodic Company Report #US-JNJFOC-20050204514 Age: Gender:Unknown I/FU:I Outcome PT Report Source Hospitalization - Anxiety Health Initial or Prolonged Paranoia Professional Company 22-Feb-2006 08:20 AM Page: 2551 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Representative Product Role Manufacturer Route Dose Duration Risperdal Consta (Risperidone) Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) SS ORAL 4 MG, 1 IN 1 DAY, ORAL Zyprexa (Olanzapine) C Date:05/26/05ISR Number: 4682061-8Report Type:Periodic Company Report #US-JNJFOC-20050204543 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Consumer Risperdal Consta Akathisia (Risperidone) Tachycardia Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Tablets SS ORAL SEE IMAGE Date:05/26/05ISR Number: 4682140-5Report Type:Periodic Company Report #US-JNJFOC-20050406963 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Risperdal Consta Overdose Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN Representative 2 WEEK, INTRA-MUSCULA R Date:05/26/05ISR Number: 4682144-2Report Type:Periodic Company Report #US-JNJFOC-20050500054 Age:20 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mania Consumer Risperdal Consta Initial or Prolonged (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Unspecified SS 3 MG, IN 1 DAY Lamictal (Lamotrigine) C 22-Feb-2006 08:20 AM Page: 2552 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/26/05ISR Number: 4682149-1Report Type:Periodic Company Report #US-JNJFOC-20050403117 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetic Ketoacidosis Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR INTRA-MUSCULA Representative R Trazodone (Trazodone) C Depakote (Valproate Semisodium) C Date:05/26/05ISR Number: 4682151-XReport Type:Periodic Company Report #US-JNJFOC-20050403590 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:05/26/05ISR Number: 4682152-1Report Type:Periodic Company Report #US-JNJFOC-20050401828 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Consta Diabetes Mellitus Professional (Risperidone) Microspheres PS INTRAVENOUS 1 IN 2 WEEK, INTRAVENOUS Date:05/26/05ISR Number: 4682153-3Report Type:Periodic Company Report #US-JNJFOC-20050400512 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Date:05/27/05ISR Number: 4675386-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-12862231 Age:9 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Tardive Dyskinesia Abilify PS Otsuka Pharmaceutical Company, Ltd. Risperidal SS Concerta C 22-Feb-2006 08:20 AM Page: 2553 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/27/05ISR Number: 4676443-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050406963 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Tylenol PS Hallucination, Auditory Risperdal Consta SS INTRAMUSCULAR Intentional Misuse Overdose Date:05/27/05ISR Number: 4676492-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050205985 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Risperdal PS OROPHARINGEAL Timolol C UNKNOWN Date:05/27/05ISR Number: 4676493-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050301664 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Prothrombin Time Abnormal Risperdal PS OROPHARINGEAL Date:05/27/05ISR Number: 4676494-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050503497 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Risperdal PS OROPHARINGEAL Hospitalization - Electrocardiogram Qt Risperdal SS OROPHARINGEAL Initial or Prolonged Corrected Interval Zocor C Prolonged Praxilene C Seresta C Triatec C Fludex C Insuline Novomix C Dose: 46 IU/day Date:05/27/05ISR Number: 4676495-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050504878 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Risperdal PS OROPHARINGEAL PRN Initial or Prolonged Rhabdomyolysis Zopiclone C prn Other Date:05/27/05ISR Number: 4676496-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040402346 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Risperdal PS OROPHARINGEAL Palpitations 22-Feb-2006 08:20 AM Page: 2554 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/31/05ISR Number: 4677794-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050105122 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Risperdal Consta PS INTRAMUSCULAR Lipids Increased Vasculitis Cerebral Date:05/31/05ISR Number: 4677795-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050404045 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Risperdal Consta PS INTRAMUSCULAR Hospitalization - Convulsion Risperdal SS OROPHARINGEAL Initial or Prolonged Extrapyramidal Disorder Tegretol SS Head Injury Tranxene C Meningitis Pneumococcal Magne-B6 C Prothrombin Time Magne-B6 C Shortened Modane C Subdural Haematoma Modane C Vasculitis Debridat C Lansoyl C 1 coffee spoon per day Date:05/31/05ISR Number: 4677796-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050502390 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Pregnancy Other Embolism Monoplegia Pulmonary Embolism Date:05/31/05ISR Number: 4677797-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050505291 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal PS OROPHARINGEAL Phosphokinase Increased Carditis Electrocardiogram Qt Prolonged Electrocardiogram St-T Change Date:05/31/05ISR Number: 4677798-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050500399 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Risperdal PS OROPHARINGEAL Initial or Prolonged Constipation Mepronizine SS OROPHARINGEAL Convulsion Mepronizine SS OROPHARINGEAL 1 cp per day Dry Mouth Nozinan SS OROPHARINGEAL Hypertonia Xanax C 3 tabs/ day Hyponatraemia Coversyl C Locked-In Syndrome Fludex C Polydipsia 22-Feb-2006 08:20 AM Page: 2555 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/31/05ISR Number: 4677799-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050506129 Age:61 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Lithium C Date:05/31/05ISR Number: 4679237-2Report Type:Direct Company Report #CTU 249917 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Risperidone 2 Mg PS ORAL 2 MG AMHS Blood Prolactin Increased ORAL Galactorrhoea Date:05/31/05ISR Number: 4679238-4Report Type:Direct Company Report #CTU 249918 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Risperidone 1 Mg PS ORAL 1 MG AMHS Blood Prolactin Increased ORAL Galactorrhoea Date:05/31/05ISR Number: 4680111-6Report Type:Expedited (15-DaCompany Report #2005077556 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Lithium (Lithium) PS ORAL 800 MG (1 IN Drug Interaction Literature 1 D), ORAL Potentiation Health Risperidone Dyskinesia Professional (Risperidone) SS ORAL 5 MG, ORAL Extrapyramidal Disorder Date:06/01/05ISR Number: 4678540-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050505292 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Risperdal PS UNKNOWN Initial or Prolonged Other Date:06/01/05ISR Number: 4678541-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050505294 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Risperdal PS OROPHARINGEAL Initial or Prolonged Vascular Dementia Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Date:06/01/05ISR Number: 4678542-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050506155 Age: Gender: I/FU:I Outcome PT Hospitalization - Dystonia Initial or Prolonged Fall Muscle Necrosis 22-Feb-2006 08:20 AM Page: 2556 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neck Injury Nerve Injury Report Source Product Role Manufacturer Route Dose Duration Risperdal PS 6-7 mg/day (in three divided doses) Date:06/02/05ISR Number: 4679662-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050506177 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Blood Prolactin Increased Risperdal Consta SS INTRAMUSCULAR Vertigo Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Taken in combination with risperidone microspheres Date:06/02/05ISR Number: 4679663-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050503542 Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Risperdal Consta PS INTRAMUSCULAR Drug Interaction Risperdal Consta SS INTRAMUSCULAR Psychomotor Hyperactivity Risperdal Consta SS INTRAMUSCULAR Neurotrat C UNKNOWN Neurotrat C UNKNOWN Neurotrat C UNKNOWN Neurotrat C UNKNOWN thiamine nitrate 100mg; pyridoxine HCl 100mg Akineton C UNKNOWN Risperdal I OROPHARINGEAL Neurocil I OROPHARINGEAL Tavor I OROPHARINGEAL Concor I OROPHARINGEAL Vesdil I OROPHARINGEAL Date:06/03/05ISR Number: 4681223-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050506276 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Neoplasm Risperdal Consta PS INTRAMUSCULAR Liver Function Test Abnormal Date:06/03/05ISR Number: 4681224-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050202900 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal PS OROPHARINGEAL Trazadone C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2557 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/05ISR Number: 4681225-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050506780 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Body Temperature Risperdal PS OROPHARINGEAL Increased Cogentin C 1-2 mg Prozac C Date:06/03/05ISR Number: 4681226-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050503497 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Risperdal PS OROPHARINGEAL Hospitalization - Electrocardiogram Qt Risperdal SS OROPHARINGEAL Initial or Prolonged Corrected Interval Zocor C Prolonged Praxilene C Seresta C Triatec C Fludex C Insuline Novomix C Dose: 46 IU/day Date:06/03/05ISR Number: 4684643-6Report Type:Expedited (15-DaCompany Report #S05-USA-02256-01 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Lexapro Fall (Escitalopram) PS ORAL 20 MG QD PO Hypotension Risperdal Loss Of Consciousness (Risperidone) SS Nausea Lipitor Nervousness (Atorvastatin) C Tremor Lasix (Furosemide) C Tenormin (Atenolol) C Prevacid (Lansoprazole) C Humalog (Insulin Lispro) C Lantus (Insulin Glargine) C Iron C Date:06/06/05ISR Number: 4682316-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050403195 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acne Risperdal PS OROPHARINGEAL Amenorrhoea Tranxene C Galactorrhoea Hirsutism Hyperprolactinaemia Pituitary Tumour Benign 22-Feb-2006 08:20 AM Page: 2558 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/06/05ISR Number: 4682317-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050500706 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nail Discolouration Risperdal PS OROPHARINGEAL Nail Disorder Epilim C UNKNOWN Nail Infection Date:06/06/05ISR Number: 4682318-0Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20050600117 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Binocular Eye Movement Risperdal PS OROPHARINGEAL Disorder Diplopia Visual Disturbance Visual Field Defect Xerophthalmia Date:06/06/05ISR Number: 4682319-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050600303 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Risperdal PS Crying Risperdal SS AM 0.25 mg Cryptorchism PM 0.50 mg Increased Appetite Concerta C Intentional Self-Injury Penile Size Reduced Suicide Attempt Weight Increased Date:06/06/05ISR Number: 4682569-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050600355 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Ganglioneuroma Other Date:06/06/05ISR Number: 4682726-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050406902 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Administration Error Risperidone PS OROPHARINGEAL 9 DAY Other Drug Interaction Hyperalimentative Torsade De Pointes Basic Solution C Hyperalimentative Basic Solution C Hyperalimentative Basic Solution C Soybean Oil C INTRAVENOUS Famotidine C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Methylprednisolone Sodium Succinate C 22-Feb-2006 08:20 AM Page: 2559 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Saccharated Ferricoxide C Tazobactam C INTRAVENOUS Ciprofloxacin C INTRAVENOUS Aminophyline C INTRAVENOUS Proteamin C INTRAVENOUS Proteamin C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Furosemide C INTRAVENOUS Hyperalimentative Basic Solution C Haloperidol I INTRAVENOUS Haloperidol I INTRAVENOUS Date:06/06/05ISR Number: 4682728-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050600327 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ventricular Fibrillation Risperdal PS OROPHARINGEAL Haloperidol SS Haloperidol SS Haloperidol SS INTRAMUSCULAR Haloperidol SS INTRAMUSCULAR Lorazepam C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Itopride Hydrochloride C OROPHARINGEAL Magnesium Oxide C OROPHARINGEAL Mianserin Hydrochloride C OROPHARINGEAL Nitrazepam C OROPHARINGEAL Flunitrazepam C OROPHARINGEAL Zopiclone C OROPHARINGEAL Date:06/06/05ISR Number: 4684910-6Report Type:Direct Company Report #CTU 250483 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Arthralgia Risperdal 0.5 Mg PS ONCE EVERY 2 Other Dehydration WKS IN MY HIP Gingival Disorder Zyprexa Unknown SS ORAL MOUTH AND Hair Disorder DAILY Hypoaesthesia Insomnia Nail Disorder Skin Disorder Date:06/06/05ISR Number: 4686386-1Report Type:Expedited (15-DaCompany Report #2005079018 Age:74 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Creatine Abnormal Initial or Prolonged Confusional State 22-Feb-2006 08:20 AM Page: 2560 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diarrhoea Drug Interaction Drug Toxicity Report Source Product Role Manufacturer Route Dose Duration Dysarthria Foreign Lithium (Lithium) PS 750 MG (250 Glasgow Coma Scale Literature MG, 3 IN 1 Abnormal Health D), Lethargy Professional Levomepromazine Nervous System Disorder Other (Levomepromazine) SS 6.25 MG, Tremor Lisinopril (Lisinopril) SS 30 MG, Risperidone (Risperidone) SS 0.5 MG (0.25 MG, 2 IN 1 D), Escitalopram (Escitalopram) SS 10 MG, Irbesartan (Irbesartan) SS 300 MG, Lormetazepam (Lormetazepam) C Metformin (Metformin) C Furosemide (Furosemide) C Repaglinide (Repaglinide) C Spironolactone (Spironolactone) C Date:06/06/05ISR Number: 4686969-9Report Type:Expedited (15-DaCompany Report #2005079018 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Increased Foreign Lithium (Lithium) PS 750 MG (250 Initial or Prolonged Creatinine Renal Literature MG, 3 IN 1 D) Clearance Increased Health Levomepromazine Drug Interaction Professional (Levomeromazine) SS 6.25 MG Glasgow Coma Scale Lisinopril Abnormal (Lisinopril) SS 30 MG Neurological Symptom Risperidone Therapeutic Agent (Risperidone) SS 0.5 MG (0.25 Toxicity MG, 2 IN 1 D) Escitalopram (Escitalopram) SS 10 MG Irbesartan (Irbesartan) SS 300 MG Lormetazepam (Lormetazepam) C Metformin (Metformin) C Furosemide 9furosemide) C Repaglinide (Repaglinide) C Spironolactone (Spironolactone) C 22-Feb-2006 08:20 AM Page: 2561 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/05ISR Number: 4683660-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050507448 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS OROPHARINGEAL Sennoside C OROPHARINGEAL Ferrous Sulfate C OROPHARINGEAL Date:06/07/05ISR Number: 4683756-2Report Type:Expedited (15-DaCompany Report #FR-SANOFI-SYNTHELABO-A02200501464 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Screen Positive Stilnox PS ORAL UNK Ill-Defined Disorder Lepticur SS ORAL UNK Nozinan SS ORAL UNK Risperdal SS ORAL UNK Date:06/07/05ISR Number: 4683814-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050507275 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysarthria Risperdal Consta PS INTRAMUSCULAR 127 DAY Initial or Prolonged Musculoskeletal Stiffness Thyroxine C OROPHARINGEAL Disability Oedema Bendrofluazide C OROPHARINGEAL Other Sedation Sluggishness Weight Increased Date:06/07/05ISR Number: 4683815-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050506960 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal Consta PS INTRAMUSCULAR Phosphokinase Increased Date:06/07/05ISR Number: 4683816-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050600935 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS OROPHARINGEAL Lisinopril C Potassium Supplement C OROPHARINGEAL Ativan C OROPHARINGEAL Neurontin C OROPHARINGEAL Glynase C OROPHARINGEAL Date:06/08/05ISR Number: 4685292-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050501737 Age:82 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Gait Disturbance Risperdal PS OROPHARINGEAL Initial or Prolonged Paralysis Glipizide C OROPHARINGEAL Other 22-Feb-2006 08:20 AM Page: 2562 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/08/05ISR Number: 4685293-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050601390 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Psychiatric Symptom Risperdal Consta SS INTRAMUSCULAR Tremor Risperdal Consta SS INTRAMUSCULAR Ativan C OROPHARINGEAL Zocor C OROPHARINGEAL Zantac C OROPHARINGEAL Lisinopril C OROPHARINGEAL Albuterol C OROPHARINGEAL Date:06/08/05ISR Number: 4685411-1Report Type:Expedited (15-DaCompany Report #200513489GDDC Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Eruption Paxil PS Glaxosmithkline ORAL 10MG per day Initial or Prolonged Rash Clobazam SS ORAL 10MG per day Phenytoin SS ORAL 200MG per day Phenobarbital SS ORAL 90MG per day Carbamazepine SS ORAL 600MG per day Risperidone SS ORAL 2MG per day No Concurrent Medication C Date:06/08/05ISR Number: 4686961-4Report Type:Expedited (15-DaCompany Report #B0382926A Age:74 YR Gender:Female I/FU:U Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Lithium Salt Initial or Prolonged Apathy Literature (Formulation Confusional State Health Unknown) (Generic) Dehydration Professional (Lithium Salt) PS 250 MG / Diarrhoea THREE TIMES Drug Interaction PER DAY / Dysarthria Lisinopril Lethargy (Formulation Neurotoxicity Unknown) (Lisionpril SS SEE DOSAGE Oliguria TEXT Somnolence Irbesartan Therapeutic Agent (Formulation Toxicity Unknown) Tremor (Irbesartan) SS Risperidone (Formulation Unknown) (Rispedridone) SS Citalopram (Formulation Unknown) (Citalopram) SS Methotrimeprazine (Formulation Unknown) (Methotrimeprazine) SS Lormetazepam C Metformin Hydrochloride C Repaglinide C 22-Feb-2006 08:20 AM Page: 2563 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Frusemide C Spironolactone C Dexetimide C Date:06/08/05ISR Number: 4687405-9Report Type:Expedited (15-DaCompany Report #2004106748 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Neurontin (Tablets) Initial or Prolonged Aggression (Gabapentin) PS 900 MG (300 Other Agitation MG, 3 IN 1 Delusion D), Depression Haldol (Haloperidol) SS Drug Ineffective Risperidone Homicidal Ideation (Risperidone) SS 6 MG (3 MG, 2 Intentional Misuse IN 1 D), Lethargy Seroquel (Quetiapine Multiple Drug Overdose Fumarate) C Psychotic Disorder Metformin Somnolence (Metformin) C Suicidal Ideation Suicide Attempt Date:06/09/05ISR Number: 4686036-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050601532 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Extrapyramidal Disorder Risperdal PS OROPHARINGEAL Reduced to 1 Myocardial Infarction mg. Risperdal SS OROPHARINGEAL Lithium Carbonate C OROPHARINGEAL Date:06/09/05ISR Number: 4686037-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050600327 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ventricular Fibrillation Risperdal PS OROPHARINGEAL Haloperidol SS Haloperidol SS Haloperidol SS INTRAMUSCULAR Haloperidol SS INTRAMUSCULAR Lorazepam C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Itopride Hydrochloride C OROPHARINGEAL Magnesium Oxide C OROPHARINGEAL Mianserin Hydrochloride C OROPHARINGEAL Nitrazepam C OROPHARINGEAL Flunitrazepam C OROPHARINGEAL Zopiclone C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2564 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/05ISR Number: 4686038-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050105122 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Risperdal PS OROPHARINGEAL stopped Lipids Increased approx 11 Vasculitis Cerebral weeks prior to patient's death Date:06/09/05ISR Number: 4686218-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050601533 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Risperdal PS OROPHARINGEAL Cardiac Failure Quetiapine Fumarate C OROPHARINGEAL Pallor Amantadine Parkinsonism Hydrochloride C OROPHARINGEAL Pyrexia Levofloxacin C OROPHARINGEAL Renal Impairment Date:06/09/05ISR Number: 4686885-2Report Type:Expedited (15-DaCompany Report #US-MERCK-0506USA00571 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Cogentin PS Merck & Co., Inc ORAL Initial or Prolonged Tardive Dyskinesia Risperidone SS UNKNOWN 6 MON Depakote C UNKNOWN Depakote C UNKNOWN Clonidine C UNKNOWN Clonidine C ORAL Clonazepam C UNKNOWN Claritin-D C UNKNOWN Date:06/09/05ISR Number: 4688455-9Report Type:Direct Company Report #CTU 250849 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Risperdal PS ORAL 0.5 MG ORALLY Initial or Prolonged Nausea HS 4 WK Sedation Lexapro SS ORAL 5 MG ORALLY Vomiting DAILY 4 WK Date:06/10/05ISR Number: 4687857-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050402185 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal PS OROPHARINGEAL Decreased Risperdal SS OROPHARINGEAL Date:06/10/05ISR Number: 4687858-6Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050601159 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal Consta PS OTHER Psychiatric Symptom 22-Feb-2006 08:20 AM Page: 2565 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/10/05ISR Number: 4688788-6Report Type:Direct Company Report #CTU 250951 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Sertraline 100 Mg PS ORAL 100 MG BID PO Initial or Prolonged Convulsion Risperidone 2mg White Blood Cell Count Janssen SS Janssen ORAL 2MG BID PO Increased Buspirone C Multivi W/ Minerals C Date:06/14/05ISR Number: 4689606-2Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050600659 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Cancer Risperdal PS OROPHARINGEAL Other Metastases To Lung Risperdal SS OROPHARINGEAL at night Date:06/14/05ISR Number: 4689607-4Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050600725 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Risperdal Consta PS INTRAMUSCULAR Date:06/14/05ISR Number: 4689608-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050602443 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Risperdal PS OROPHARINGEAL Parkinson'S Disease Aricept C OROPHARINGEAL Escitalopram Oxalate C OROPHARINGEAL Date:06/14/05ISR Number: 4689867-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050600303 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Risperdal PS Crying Risperdal SS AM 0.25 mg Cryptorchism PM 0.50 mg Head Banging Concerta C Increased Appetite Concerta C Intentional Self-Injury Concerta C Penile Size Reduced Suicide Attempt Weight Increased Date:06/14/05ISR Number: 4690080-0Report Type:Expedited (15-DaCompany Report #2005-129153-NL Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Mirtazapine PS ORAL 15 MG Initial or Prolonged Headache Risperidone SS ORAL 3 MG Hyperprolactinaemia Di-Antalvic SS ORAL 1 DF Hypertension Metformin Pituitary Tumour Benign Hydrochloride SS ORAL 1700 MG Somnolence Tumour Necrosis Vomiting 22-Feb-2006 08:20 AM Page: 2566 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/05ISR Number: 4690864-9Report Type:Direct Company Report #CTU 251127 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Seroquel PS 700MG TOTAL Initial or Prolonged Extrapyramidal Disorder DAILY DOSE Renal Failure Risperdal SS 6 MG TOTAL DAILY DOSE Zoloft C Hydrochlorothiazide C Clonidine C Date:06/14/05ISR Number: 4691915-8Report Type:Direct Company Report #CTU 251161 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cognitive Disorder Risperidone PS 0.5 M-3 MG Euphoric Mood Movement Disorder Psychomotor Hyperactivity Date:06/14/05ISR Number: 4692205-XReport Type:Expedited (15-DaCompany Report #2005079018 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Lithium (Lithium) PS 750 MG (250 Initial or Prolonged Apathy Literature MG, 3 IN 1 D) Blood Creatinine Health Levomepromazine Increased Professional (Levomepromazine) SS 6.25 MG Condition Aggravated Lisinopril Confusional State (Lisinopril) SS 30 MG Creatinine Renal Risperidone Clearance Increased (Risperidone) SS 0.5 MG (0.25 Dehydration MG, 2 IN 1 D) Diarrhoea Escitalopram Drug Interaction (Escitalopram) SS 10 MG Dysarthria Irbesartan Glasgow Coma Scale (Irbesartan) SS 300 MG Abnormal Lormetazepam C Lethargy Metformin C Nervous System Disorder Furosemide C Neurotoxicity Repaglinide C Oliguria Spironolactone C Therapeutic Agent Toxicity Tremor Date:06/15/05ISR Number: 4690598-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050505292 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Risperdal PS OROPHARINGEAL 30 DAY Initial or Prolonged Bradycardia Tavor C OROPHARINGEAL 28 DAY Other Tavor C OROPHARINGEAL 28 DAY 22-Feb-2006 08:20 AM Page: 2567 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/05ISR Number: 4690599-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050601587 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Disturbance In Social Risperdal Consta PS INTRAMUSCULAR Behaviour Priapism Date:06/15/05ISR Number: 4690600-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050405182 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Risperdal PS OROPHARINGEAL 68 DAY Date:06/15/05ISR Number: 4690623-7Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0363979A Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Paxil PS Glaxosmithkline ORAL Anger Risperdal SS Delusion Disinhibition Drug Withdrawal Syndrome Feeling Abnormal Headache Insomnia Mental Impairment Murder Negativism Date:06/16/05ISR Number: 4691663-4Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20050600800 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Risperdal PS OROPHARINGEAL Initial or Prolonged Convulsion Zyprexa C Hypotension Melleril C Date:06/16/05ISR Number: 4692012-8Report Type:Direct Company Report #CTU 251364E Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Olanzapine Injection Coronary Artery 10 Mg Eli Atherosclerosis Lilly PS Eli Lilly INTRAMUSCULAR 10 MG IF PO Loss Of Consciousness REFUSED Malaise INTRAMUSCU Oral Intake Reduced Risperidone M-Tab Refusal Of Treatment By 2 Mg Janssen SS Janssen ORAL 2 MG BID Patient ORAL Date:06/16/05ISR Number: 4692042-6Report Type:Direct Company Report #CTU 251346 Age:81 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Blood Creatinine 22-Feb-2006 08:20 AM Page: 2568 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Chromaturia Confusional State Dehydration Report Source Product Role Manufacturer Route Dose Duration Depressed Level Of Mirtazapine 30 Mg PS ORAL 30 MG QHS Consciousness ORAL Iatrogenic Injury Risperidone 1 Mg SS ORAL ORAL Lethargy Mental Status Changes Miosis Oral Intake Reduced Sedation Date:06/16/05ISR Number: 4694196-4Report Type:Direct Company Report #CTU 251293 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal PS 2 MG BID 6 MON Phosphokinase Increased Depakote C Ambien C Date:06/17/05ISR Number: 4692548-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050601892 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Concerta PS OROPHARINGEAL Growth Retardation Risperdal SS Speech Disorder Date:06/17/05ISR Number: 4693102-6Report Type:Expedited (15-DaCompany Report #200511992FR Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Lasilix PS Aventis Initial or Prolonged Impaired Gastric Emptying Pharmaceuticals Inc. ORAL Intestinal Obstruction Teralithe SS ORAL Motilyo SS ORAL Risperdal SS ORAL Mopral C ORAL Date:06/17/05ISR Number: 4693169-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050303718 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Risperdal PS OROPHARINGEAL Initial or Prolonged Somnolence Topalgic SS OROPHARINGEAL Unresponsive To Pain Imovane SS OROPHARINGEAL Stimuli Flixotide C 3 PUFFS PER DAY Aprovel C Cortancyl C Actonel C Mopral C Hemigoxine C Caltrate C 22-Feb-2006 08:20 AM Page: 2569 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/17/05ISR Number: 4693386-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050600327 Age:74 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Encephalopathy Risperdal PS OROPHARINGEAL Prostration Haloperidol SS 10 mg daily Restlessness Haloperidol SS Ventricular Fibrillation Haloperidol SS INTRAMUSCULAR 30 mg daily Haloperidol SS INTRAMUSCULAR Lorazepam C OROPHARINGEAL Biperiden Hydrochloride C OROPHARINGEAL Itopride Hydrochloride C OROPHARINGEAL Magnesium Oxide C OROPHARINGEAL Mianserin Hydrochloride C OROPHARINGEAL Nitrazepam C OROPHARINGEAL Flunitrazepam C OROPHARINGEAL Zopiclone C OROPHARINGEAL Date:06/17/05ISR Number: 4693388-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050603225 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Iron Decreased Risperdal PS OROPHARINGEAL Initial or Prolonged C-Reactive Protein Nicardipine Increased Hydrochloride C OROPHARINGEAL Lung Neoplasm Malignant Pantethine C OROPHARINGEAL Bromvalerylurea C OROPHARINGEAL Lorazepam C OROPHARINGEAL Theophylline C OROPHARINGEAL Fenoterol Hydrobromide C OROPHARINGEAL Ambroxol Hydrochloride C OROPHARINGEAL Clonazepam C OROPHARINGEAL Amlodipine Besilate C OROPHARINGEAL Sodium Picosulfate C OROPHARINGEAL Sennoside C OROPHARINGEAL Date:06/17/05ISR Number: 4694871-1Report Type:Expedited (15-DaCompany Report #2004106748 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Neurontin (Tablets) Initial or Prolonged Aggression (Gabapentin) PS UNKNOWN 900 MG, (300 Other Agitation MG, 3 IN 1 Delusion D), UNKNOWN Depression Haldol (Haloperidol) SS UNKNOWN UNKNOWN Drug Ineffective Risperidone Homicidal Ideation (Risperidone) SS UNKNOWN 6 MG (3 MG, 2 Intentional Misuse IN 1 D), Lethargy UNKNOWN Multiple Drug Overdose Seroquel (Quetiapine Psychotic Disorder Fumarate) C Somnolence Metformin Suicidal Ideation (Metformin) C Suicide Attempt 22-Feb-2006 08:20 AM Page: 2570 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/20/05ISR Number: 4694253-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050106202 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Risperdal PS OROPHARINGEAL 1 mg in am Haemoglobin Decreased and 2 mg Red Blood Cell Count (time not Decreased specified) White Blood Cell Count Risperdal SS OROPHARINGEAL Decreased Lamotrigine C Depakote C Zoloft C OROPHARINGEAL Inh C Neurontin C Date:06/20/05ISR Number: 4694254-4Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20050201419 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aortic Valve Stenosis Risperdal PS Started by Drug Toxicity general Platelet Count Decreased practitioner (dose and schedule Risperdal SS Dose re-adjusted by general practitioner/ family Risperdal SS Dose decreased by psychiatrist to 0.5 mg (schedule Venlafaxine C Date:06/20/05ISR Number: 4694255-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050505291 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperdal PS OROPHARINGEAL Initial or Prolonged Phosphokinase Increased Other Electrocardiogram Qt Prolonged Electrocardiogram St-T Change Date:06/20/05ISR Number: 4695776-2Report Type:Direct Company Report #CTU 251542 Age:45 YR Gender:Female I/FU:I Outcome PT Disability Agoraphobia Alopecia Anxiety Balance Disorder Coordination Abnormal Corrective Lens User Dysphagia Feeling Abnormal 22-Feb-2006 08:20 AM Page: 2571 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hallucination, Visual Hemiplegia Insomnia Report Source Product Role Manufacturer Route Dose Duration Mania Risperdal PS ? 4 MG DAILY Memory Impairment Wellbutrin C Menorrhagia Benadryl C Nightmare Ovarian Neoplasm Panic Attack Post-Traumatic Stress Disorder Speech Disorder Uterine Neoplasm Visual Acuity Reduced Date:06/20/05ISR Number: 4695797-XReport Type:Direct Company Report #CTU 251540 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Treatment Noncompliance Risperdal PS 3 MG CUT 1/2, Other Tremor 1.5 MG Date:06/21/05ISR Number: 4695627-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050501750 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Risperdal Consta PS INTRAMUSCULAR 15 DAY Initial or Prolonged Prolonged Risperdal SS OROPHARINGEAL Other Date:06/21/05ISR Number: 4695628-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050603070 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperdal Consta PS INTRAMUSCULAR For over 1 Initial or Prolonged Drug Abuser year Date:06/21/05ISR Number: 4695629-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050205999 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Risperdal PS OROPHARINGEAL Hospitalization - Drug Administration Error Haloperidol SS INTRAVENOUS Initial or Prolonged Incorrect Route Of Drug Midazolam C INTRAVENOUS Administration Propofol C Sinus Arrest Date:06/21/05ISR Number: 4695630-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050603042 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Agitation Risperdal SS OROPHARINGEAL Irritability Risperdal SS OROPHARINGEAL Restlessness Cogentin C OROPHARINGEAL Suicidal Ideation Ativan C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2572 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/21/05ISR Number: 4695866-4Report Type:Expedited (15-DaCompany Report #FR-SANOFI-SYNTHELABO-A02200501512 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Stilnox PS ORAL 1 DAY Initial or Prolonged Dysstasia Mepronizine SS ORAL 1 DAY Fall Anafranil SS ORAL 1 DAY Headache Risperdal SS ORAL 1 DAY Hyperhidrosis Mepronizine C ORAL UNK YR Hypertension Anafranil C ORAL UNK YR Insomnia Risperdal C ORAL UNK YR Multiple Drug Overdose Temesta C ORAL UNK YR Muscle Rigidity Propofan C UNKNOWN UNK Neuroleptic Malignant Syndrome Pyrexia Tremor Date:06/22/05ISR Number: 4697195-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050405498 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Sinus Arrhythmia Risperdal PS OROPHARINGEAL Initial or Prolonged Risperdal SS OROPHARINGEAL Other Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Date:06/22/05ISR Number: 4697408-6Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0292151-00 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Depakote Tablets PS ORAL 107 DAY Initial or Prolonged Encephalopathy Risperidone SS ORAL 12 DAY Lung Disorder Risperidone SS 12 DAY Psychomotor Retardation Nicardipine Social Avoidant Behaviour Hydrochloride C ORAL Somnolence Nulytely C ORAL Bisoprolol C ORAL Alprazolam C ORAL Alprazolam C Zopiclone C ORAL Date:06/22/05ISR Number: 4698946-2Report Type:Direct Company Report #CTU 251712 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Body Temperature Ziprasidone PS INTRAVENOUS 20 MG IM PRN Hospitalization - Increased Risperidone SS 1 MG Q HS Initial or Prolonged Convulsion Phenytoin C Neuroleptic Malignant Ceftriaxone C Syndrome Tylenol C Ibuprofen C 22-Feb-2006 08:20 AM Page: 2573 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/22/05ISR Number: 4699101-2Report Type:Direct Company Report #CTU 251771 Age:37 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Risperidone PS ORAL 4 MG Q HS , Swollen Tongue PO Treatment Noncompliance Zoloft C Visteril C Date:06/22/05ISR Number: 4699423-5Report Type:Expedited (15-DaCompany Report #DSA_26586_2005 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Foreign Lorazepam PS ORAL 2 MG Q DAY PO Initial or Prolonged Haematuria Health Risperidone SS ORAL DF Q DAY PO Hypertension Professional Zolpidem SS ORAL 10 MG Q DAY Insomnia Other PO Oral Candidiasis Sulpametokazol C Suicidal Ideation Trimethoprim C Date:06/23/05ISR Number: 4697754-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050603854 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Retinal Vein Occlusion Risperdal Consta PS INTRAMUSCULAR Other Date:06/23/05ISR Number: 4697755-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041101099 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Risperdal PS OROPHARINGEAL 6 YR Initial or Prolonged Diabetes Mellitus Risperdal SS OROPHARINGEAL 6 YR Other Non-Insulin-Dependent Benadryl C OROPHARINGEAL Lorazepam C OROPHARINGEAL Diovan C OROPHARINGEAL Date:06/23/05ISR Number: 4697756-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050601533 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Risperdal PS OROPHARINGEAL Parkinsonism Quetiapine Fumarate C OROPHARINGEAL Renal Impairment Amantadine Hydrochloride C OROPHARINGEAL Levofloxacin C OROPHARINGEAL Date:06/23/05ISR Number: 4697757-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050604485 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Count Decreased Risperdal PS OROPHARINGEAL Initial or Prolonged Lithium C 22-Feb-2006 08:20 AM Page: 2574 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/05ISR Number: 4697758-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050504878 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Risperdal PS OROPHARINGEAL PRN Initial or Prolonged Gait Disturbance Risperdal SS OROPHARINGEAL Other Parkinsonism Risperdal SS OROPHARINGEAL Rhabdomyolysis Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Zopiclone C Zopiclone C prn Lovastatin C Donezepil C d/c in Jul-04 Trazodone C Date:06/23/05ISR Number: 4697759-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040702328 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Risperdal PS OROPHARINGEAL Alanine Aminotransferase Risperdal SS OROPHARINGEAL Increased Risperdal SS OROPHARINGEAL Constipation Risperdal SS OROPHARINGEAL Leukopenia Risperdal SS OROPHARINGEAL Muscle Rigidity Risperdal SS OROPHARINGEAL Thirst Risperdal SS OROPHARINGEAL Tremor Risperdal SS OROPHARINGEAL Weight Increased Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Flunitrazepam C OROPHARINGEAL Flunitrazepam C OROPHARINGEAL Flunitrazepam C OROPHARINGEAL Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Trihexyphenidyl Hydrochloride C OROPHARINGEAL 126 DAY Etizolam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Lorazepam C OROPHARINGEAL 51 DAY Olanzapine C OROPHARINGEAL 51 DAY Olanzapine C OROPHARINGEAL 51 DAY Quazepam C OROPHARINGEAL 56 DAY Quazepam C OROPHARINGEAL 56 DAY 22-Feb-2006 08:20 AM Page: 2575 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Quazepam C OROPHARINGEAL 56 DAY Quazepam C OROPHARINGEAL 56 DAY Sennoside C Sennoside C Sennoside C Sennoside C Brotizolam C Brotizolam C Magnesium Oxide C Magnesium Oxide C Magnesium Oxide C Magnesium Oxide C Magnesium Oxide C Magnesium Oxide C Magnesium Oxide C Date:06/23/05ISR Number: 4698210-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050602622 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Risperdal PS OROPHARINGEAL Initial or Prolonged Gastrointestinal Motilyo SS OROPHARINGEAL Obstruction Lasilix SS OROPHARINGEAL Impaired Gastric Emptying Teralithe SS OROPHARINGEAL Teralithe SS OROPHARINGEAL Mopral C UNKNOWN Date:06/23/05ISR Number: 4698211-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050603246 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Haloperidol PS UNKNOWN Depression Risperdal Consta SS INTRAMUSCULAR Seroquel SS Solian SS Cipralex SS OROPHARINGEAL Start date = End of APR-2005 Date:06/23/05ISR Number: 4698212-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050604252 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Function Test Risperdal PS OROPHARINGEAL Abnormal Platelet Count Decreased Date:06/23/05ISR Number: 4698213-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050406902 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Administration Error Risperidone PS OROPHARINGEAL 9 DAY Other Drug Interaction Hyperalimentative Torsade De Pointes Basic Solution C Hyperalimentative Basic Solution C Hyperalimentative 22-Feb-2006 08:20 AM Page: 2576 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Basic Solution C Soybean Oil C INTRAVENOUS Famotidine C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Methylprednisolone Sodium Succinate C Saccharated Ferricoxide C Tazobactam C INTRAVENOUS Ciprofloxacin C INTRAVENOUS Aminophyline C INTRAVENOUS Proteamin C INTRAVENOUS Proteamin C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Multivitamin C INTRAVENOUS Furosemide C INTRAVENOUS Hyperalimentative Basic Solution C Haloperidol I INTRAVENOUS Haloperidol I INTRAVENOUS Date:06/23/05ISR Number: 4698214-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041207554 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adrenal Neoplasm Risperdal PS OROPHARINGEAL Initial or Prolonged Beta 2 Microglobulin Alprazolam C OROPHARINGEAL Increased Flunitrazepam C Oedema Furosemide C Pituitary-Dependent Cushing'S Syndrome Date:06/23/05ISR Number: 4698215-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050605540 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal PS OROPHARINGEAL Renal Failure Acute Levomepromazine Maleate SS OROPHARINGEAL Zotepine C OROPHARINGEAL Nitrazepam C OROPHARINGEAL Terazosin Hydrochloride C OROPHARINGEAL Date:06/23/05ISR Number: 4698216-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050405003 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Induced Risperdal PS Blighted Ovum Risperdal SS Drug Exposure During Prozac C Pregnancy Pregnancy 22-Feb-2006 08:20 AM Page: 2577 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/05ISR Number: 4699226-1Report Type:Direct Company Report #CTU 251881 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Encopresis Risperdal (Risperidone) 0.25 Mg Tablet PS ORAL 0.125 MG PO Q AM; 0.5 MG PO Q HS Date:06/24/05ISR Number: 4698879-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050401115 Age:84 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hiccups Risperdal PS UNKNOWN Initial or Prolonged Tardive Dyskinesia Risperdal SS UNKNOWN Tiapride Hydrochloride C Date:06/24/05ISR Number: 4698880-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050502005 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Risperidone PS OROPHARINGEAL Initial or Prolonged Drug Exposure During Trihexyphenidyl Other Pregnancy Hydrochloride SS OROPHARINGEAL Date:06/24/05ISR Number: 4699166-8Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20050603414 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Flutter Concerta PS UNKNOWN Conduction Disorder Risperdal SS OROPHARINGEAL Date:06/24/05ISR Number: 4699179-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050600346 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Risperdal PS OROPHARINGEAL Pyrexia Lexomil C Date:06/27/05ISR Number: 4700252-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050604075 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Water Intoxication Risperdal Consta PS INTRAMUSCULAR dose Initial or Prolonged suspended following the event 1 MON Depakote C Tiapridal C 22-Feb-2006 08:20 AM Page: 2578 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/27/05ISR Number: 4700253-6Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050605168 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer In Situ Risperdal PS 16 MON Breast Neoplasm Date:06/27/05ISR Number: 4700254-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040501364 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Discomfort Risperdal PS OROPHARINGEAL Abdominal Distension Risperdal SS OROPHARINGEAL Abdominal Pain Lower Risperdal SS OROPHARINGEAL Acne Wellbutrin C Anxiety Atelectasis Blood Prolactin Increased Constipation Crohn'S Disease Decreased Appetite Delusion Depression Diarrhoea Disturbance In Attention Diverticulitis Galactorrhoea Gastric Polyps Hallucination Headache Hepatic Lesion Hyperprolactinaemia Infertility Insomnia Malaise Memory Impairment Mitral Valve Incompetence Panic Attack Paranoia Pituitary Tumour Benign Rectal Polyp Schizoaffective Disorder Sedation Treatment Noncompliance Vision Blurred Visual Disturbance Weight Decreased Date:06/27/05ISR Number: 4701587-1Report Type:Expedited (15-DaCompany Report #L05-BEL-02196-01 Age:74 YR Gender:Female I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Apathy Blood Creatinine Increased Dehydration Drug Interaction Dysarthria Neurotoxicity 22-Feb-2006 08:20 AM Page: 2579 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oliguria Somnolence Therapeutic Agent Report Source Product Role Manufacturer Route Dose Duration Toxicity Foreign Escitalopram PS ORAL 10 MG QD PO Tremor Literature Lithium SS 250 MG TID Health Levomepromazine SS 6.25 MG QD Professional Lisinopril SS 30 MG QD Other Lisinopril SS 20 MG QD Irbesartan SS 300 MG QD Spironolactone SS 50 MG QD Risperidone SS 0.25 MG QD Furosemide C Repaglinide C Metformin C Lormetazepam C Date:06/27/05ISR Number: 4701891-7Report Type:Expedited (15-DaCompany Report #2004106748 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Neurontin (Tablets) Initial or Prolonged Aggression (Gabapentin) PS 900 MG (300 Other Agitation MG,3 IN 1 D) Condition Aggravated Neurontin Depression (Gabapentin) SS 900 MG (300 Drug Ineffective MG,3 IN 1 D) Hallucination, Auditory Haldol (Haloperidol) SS Homicidal Ideation Risperidone Intentional Misuse (Risperidone) SS 6 MG (3 MG,2 Lethargy IN 1 D) Multiple Drug Overdose Seroquel (Quetiapine Psychotic Disorder Fumarate) C Somnolence Metformin Stress (Metformin) C Suicidal Ideation Suicide Attempt Date:06/28/05ISR Number: 4701187-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050604623 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal Consta PS INTRAMUSCULAR Decreased Risperdal C OROPHARINGEAL Date:06/28/05ISR Number: 4701188-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050604820 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Vascular Risperdal Consta PS INTRAMUSCULAR Occlusion Date:06/28/05ISR Number: 4701189-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050605294 Age:10 YR Gender:Male I/FU:I Outcome PT Other Aphasia Hypokinesia 22-Feb-2006 08:20 AM Page: 2580 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Mental Impairment Report Source Product Role Manufacturer Route Dose Duration Risperdal PS OROPHARINGEAL Date:06/28/05ISR Number: 4701190-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050600327 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Glucose Increased Risperdal PS OROPHARINGEAL Blood Pressure Decreased Risperdal SS OROPHARINGEAL Body Temperature Haloperidol SS 10 mg daily Increased Haloperidol SS Cardiac Arrest Haloperidol SS INTRAMUSCULAR 30 mg daily Delirium Haloperidol SS INTRAMUSCULAR Diet Refusal Lorazepam C OROPHARINGEAL Encephalopathy Biperiden Excitability Hydrochloride C OROPHARINGEAL Prostration Itopride Respiratory Arrest Hydrochloride C OROPHARINGEAL Restlessness Magnesium Oxide C OROPHARINGEAL Ventricular Fibrillation Mianserin Hydrochloride C OROPHARINGEAL Nitrazepam C OROPHARINGEAL Flunitrazepam C OROPHARINGEAL Zopiclone C OROPHARINGEAL Date:06/29/05ISR Number: 4702940-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050506177 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Blood Prolactin Increased Risperdal Consta SS INTRAMUSCULAR Other Vertigo Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Taken in combination with risperidone microspheres Norvasc C UNKNOWN Prevacid C UNKNOWN Glucophage C UNKNOWN Actonel C UNKNOWN Date:06/29/05ISR Number: 4702941-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050601390 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyskinesia Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Psychiatric Symptom Risperdal Consta SS INTRAMUSCULAR Tremor Risperdal Consta SS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Ativan C OROPHARINGEAL Zocor C OROPHARINGEAL Zantac C OROPHARINGEAL Lisinopril C OROPHARINGEAL Albuterol C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2581 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/29/05ISR Number: 4702942-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050606498 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal PS OROPHARINGEAL Date:06/29/05ISR Number: 4702943-8Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20050404715 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Status Epilepticus Risperdal PS UNKNOWN Risperdal SS UNKNOWN Paxil C Paxil C Prozac C Zyprexa C Effexor C Date:06/29/05ISR Number: 4705727-XReport Type:Expedited (15-DaCompany Report #2005-BP-10433RO Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Lithium Carbonate Initial or Prolonged Apathy Literature (Lithium Carbonate) PS ORAL 250 MG TID, Blood Creatinine Health PO Increased Professional Escitalopram Confusional State (Escitalopram) SS ORAL 10 MG/DAY, PO Dehydration Levomepromazine Diarrhoea (Levomepromazine) SS ORAL 6.25 MG/DAY, Drug Interaction PO Dysarthria Lisinopril Lethargy (Lisinopril) SS 30 MG/DAY Oliguria Irbesartan Somnolence (Irbesartan) SS 300 MG/DAY Therapeutic Agent Furosemide Toxicity (Furosemide) SS 30 MG/DAY Tremor Spironolactone (Spironolactone) SS 50 MG/DAY Risperidone (Risperidone) SS 0.25 MG BID (2 IN 1 D) Lormetazepam (Lormetazepam) C Metformin (Metformin) C Rapaglinide (Repaglinide) C Date:06/30/05ISR Number: 4703542-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050605534 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gum Neoplasm Malignant Fentanyl PS TRANSDERMAL dosage Stage Unspecified unspecified 10 DAY Malignant Neoplasm Fentanyl SS TRANSDERMAL dosage Progression unspecified 10 DAY Durotep SS TRANSDERMAL 8 DAY Risperdal SS OROPHARINGEAL 4 ml administered 2 DAY 22-Feb-2006 08:20 AM Page: 2582 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tagafur Uracil C OROPHARINGEAL Gentamicin Sulfate C Povidine Iodine C Sodium Thiosulfate C Sodium Bicarbonate-Anhydrou s Monobasic Sodium Phosphate C Sodium Bicarbonate-Anhydrou s Monobasic Sodium Phosphate C Sodium Bicarbonate-Anhydrou s Monobasic Sodium Phosphate C Glycerin C RECTAL Glycerin C RECTAL Trimebutine Maleate C OROPHARINGEAL Lidocaine Hydrochloride C TOPICAL Hydrocortisone Sodium Succinate C Sulbactam-Cefoperazo ne C Sulbactam-Cefoperazo ne C Haloperidol C Hydroxyzine Hydrochloride C Senna Leaf-Senna Pod C Sodium Picosulfate C OROPHARINGEAL Mecobalamin C OROPHARINGEAL Difenidol Hydrochloride C OROPHARINGEAL Diclofenac Sodium C OROPHARINGEAL Bromhexine Hydrochloride C RESPIRATORY (INHALATION) Morphine Hydrochloride C OROPHARINGEAL White Petrolatum C TOPICAL White Petrolatum C TOPICAL White Petrolatum C TOPICAL Date:06/30/05ISR Number: 4704261-0Report Type:Expedited (15-DaCompany Report #PHFR2005GB02271 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Tegretol PS Novartis Sector: Other Death Pharma ORAL 600 mg, BID Clobazam SS ORAL 10 mg, BID Risperidone SS ORAL 0.5 mg, BID Topiramate C ORAL 50mg/day 37440MIN 22-Feb-2006 08:20 AM Page: 2583 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/05ISR Number: 4704333-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041101099 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Risperdal PS OROPHARINGEAL 6 YR Initial or Prolonged Blood Glucose Increased Risperdal SS OROPHARINGEAL 6 YR Other Diabetes Mellitus Benadryl C OROPHARINGEAL Non-Insulin-Dependent Lorazepam C OROPHARINGEAL Hypoaesthesia Diovan C OROPHARINGEAL Pregnancy Date:06/30/05ISR Number: 4704334-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050103371 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Risperdal PS OROPHARINGEAL (reduced to Initial or Prolonged Anxiety one-half Other Ascites tablet) Depression Risperdal SS OROPHARINGEAL Diabetes Mellitus Effexor C OROPHARINGEAL Headache Effexor C OROPHARINGEAL 150 mg Heart Rate Increased strength Hepatic Steatosis Remeron C OROPHARINGEAL Hypertension Hypoaesthesia Hypogonadism Insomnia Liver Function Test Abnormal Nephrolithiasis Rash Generalised Date:06/30/05ISR Number: 4704541-9Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0287974-00 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chapped Lips Depakote Tablets PS ORAL 39 DAY Hospitalization - Conjunctivitis Infective Risperidone SS ORAL 41 DAY Initial or Prolonged Crepitations Gliclazide SS ORAL 18 DAY Cytolytic Hepatitis Clonazepam SS ORAL 1 MON Dermatitis Exfoliative Paroxetine Drug Rash With Hydrochloride C UNKNOWN Eosinophilia And Systemic Alprazolam C UNKNOWN Symptoms Face Oedema General Physical Health Deterioration Hypotension Lichenoid Keratosis Lymphadenopathy Oliguria Oxygen Saturation Decreased Pancytopenia Pulmonary Oedema Pyrexia Skin Exfoliation 22-Feb-2006 08:20 AM Page: 2584 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/05ISR Number: 4704628-0Report Type:Expedited (15-DaCompany Report #US-MERCK-0506USA03778 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Cogentin PS Merck & Co., Inc ORAL Initial or Prolonged Tremor Risperdal SS UNKNOWN Date:07/01/05ISR Number: 4705099-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050605994 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Risperdal Consta PS INTRAMUSCULAR 2 MON Initial or Prolonged Euphoric Mood Depakine Chrono C Depakine Chrono C Anafranil C Skenan C Beclomethasone C RESPIRATORY (INHALATION) Zolpidem C Lysanxia C Noctran C Noctran C Noctran C Date:07/01/05ISR Number: 4705100-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050606243 Age:60 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebellar Atrophy Risperdal PS OROPHARINGEAL Condition Aggravated Risperdal Consta SS INTRAMUSCULAR Gait Disturbance Risperdal Consta SS INTRAMUSCULAR Poverty Of Speech Schizophrenia, Paranoid Type Date:07/01/05ISR Number: 4705101-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050506276 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Neoplasm Risperdal Consta PS INTRAMUSCULAR Liver Function Test Glicazide C mane Abnormal Vitamin B Co Strong C Dose = 1 tablet Thiamine C Frusemide C mane Spironolactone C mane Omeprazole C mane Date:07/01/05ISR Number: 4705102-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050602245 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Risperdal PS OROPHARINGEAL Initial or Prolonged Voglibose C OROPHARINGEAL Tamsulosin C OROPHARINGEAL Glimepiride C OROPHARINGEAL Sennoside C OROPHARINGEAL 2 dosage form Distigmine C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2585 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/05ISR Number: 4705103-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041207554 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adrenal Neoplasm Risperdal PS OROPHARINGEAL Initial or Prolonged Beta 2 Microglobulin Alprazolam C OROPHARINGEAL Increased Flunitrazepam C Oedema Furosemide C Pituitary-Dependent Cushing'S Syndrome Date:07/01/05ISR Number: 4705108-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050607156 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal PS OROPHARINGEAL Phosphokinase Increased Haloperidol SS Bradykinesia Parkinsonism Date:07/01/05ISR Number: 4705189-2Report Type:Expedited (15-DaCompany Report #PHNU2005DE02372 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pleurothotonus Exelon PS Novartis Sector: Initial or Prolonged Respiratory Tract Pharma ORAL 9 mg/day Infection Melneurin SS ORAL 75 mg/day 12960MIN Melneurin SS ORAL 25 mg/day 15840MIN Melneurin SS ORAL 75 mg/day 4320 MIN Melneurin SS ORAL 125 mg/day 33120MIN Risperdal SS ORAL 0.5 mg/day 5760 MIN Date:07/01/05ISR Number: 4705352-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050601532 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Delirium Risperdal PS OROPHARINGEAL Reduced to 1 Extrapyramidal Disorder mg. Myocardial Infarction Risperdal SS OROPHARINGEAL Pneumonia Chlorpromazine Hibenzate SS Lithium Carbonate C OROPHARINGEAL Flunitrazepam C Date:07/01/05ISR Number: 4705353-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050304267 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Risperdal PS OROPHARINGEAL 3 DAY Hospitalization - Death Risperdal SS OROPHARINGEAL 3 DAY Initial or Prolonged Haematemesis Aspirin Dialuminate C OROPHARINGEAL 3 DAY Neuroleptic Malignant Aspirin Dialuminate C OROPHARINGEAL 3 DAY Syndrome Aspirin Dialuminate C OROPHARINGEAL 3 DAY Renal Failure Acute 22-Feb-2006 08:20 AM Page: 2586 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/01/05ISR Number: 4705359-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050605534 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Gum Neoplasm Malignant Fentanyl PS TRANSDERMAL dosage Stage Unspecified unspecified 10 DAY Malignant Neoplasm Fentanyl SS TRANSDERMAL dosage Progression unspecified 10 DAY Durotep SS TRANSDERMAL 8 DAY Risperdal SS OROPHARINGEAL 4 ml administered 2 DAY Tagafur Uracil C OROPHARINGEAL Gentamicin Sulfate C Povidine Iodine C Sodium Thiosulfate C Sodium Bicarbonate-Anhydrou s Monobasic Sodium Phosphate C Sodium Bicarbonate-Anhydrou s Monobasic Sodium Phosphate C Sodium Bicarbonate-Anhydrou s Monobasic Sodium Phosphate C Glycerin C RECTAL Glycerin C RECTAL Trimebutine Maleate C OROPHARINGEAL Lidocaine Hydrochloride C TOPICAL Hydrocortisone Sodium Succinate C Sulbactam-Cefoperazo ne C Sulbactam-Cefoperazo ne C Haloperidol C Hydroxyzine Hydrochloride C Senna Leaf-Senna Pod C Sodium Picosulfate C OROPHARINGEAL Mecobalamin C OROPHARINGEAL Difenidol Hydrochloride C OROPHARINGEAL Diclofenac Sodium C OROPHARINGEAL Bromhexine Hydrochloride C RESPIRATORY (INHALATION) Morphine Hydrochloride C OROPHARINGEAL White Petrolatum C TOPICAL White Petrolatum C TOPICAL White Petrolatum C TOPICAL 22-Feb-2006 08:20 AM Page: 2587 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/05ISR Number: 4706454-5Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0564619A Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eyelid Margin Crusting Lamictal PS Glaxosmithkline ORAL MON Headache Risperdal SS Hemiparesis Methadone SS Glaxosmithkline Musculoskeletal Stiffness Nausea Sputum Discoloured Torticollis Treatment Noncompliance Date:07/05/05ISR Number: 4706460-0Report Type:Expedited (15-DaCompany Report #CA-GLAXOSMITHKLINE-A0564882A Age:85 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Failure Paxil PS Glaxosmithkline Drug Interaction Oxygen SS Localised Infection Risperdal SS Oedema Peripheral Coumadin C Glaxosmithkline Pulmonary Oedema Respiratory Distress Date:07/05/05ISR Number: 4708017-4Report Type:Direct Company Report #CTU 252462 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Arthralgia Risperdal 0.5 Mg PS ONCE EVERY 2 Other Dehydration WKS IN MY HIP Gingival Injury MOUTH AND Hair Disorder DAILY Hypoaesthesia Zyprexa SS Insomnia Nail Disorder Skin Disorder Date:07/06/05ISR Number: 4706887-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050606265 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Risperdal PS OROPHARINGEAL Life-Threatening Death Tegretol SS OROPHARINGEAL Clobazam SS OROPHARINGEAL Topiramate C OROPHARINGEAL 26 DAY Topiramate C OROPHARINGEAL 26 DAY Date:07/06/05ISR Number: 4706888-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050201372 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Induced Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Drug Exposure During Risperdal Consta SS INTRAMUSCULAR Pregnancy Pregnancy Unevaluable Event 22-Feb-2006 08:20 AM Page: 2588 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/05ISR Number: 4706889-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050606810 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pleural Infection Risperdal PS OROPHARINGEAL Initial or Prolonged Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Date:07/06/05ISR Number: 4706890-7Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20050606947 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypotension Risperdal Consta PS INTRAMUSCULAR Other Flufenazin SS Phenprobamate SS Date:07/06/05ISR Number: 4706891-9Report Type:Expedited (15-DaCompany Report #BG-JNJFOC-20050700320 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypersensitivity Risperdal Consta PS INTRAMUSCULAR Localised Oedema Risperdal Consta SS INTRAMUSCULAR Suffocation Feeling Risperdal C UNKNOWN Date:07/06/05ISR Number: 4709632-4Report Type:Direct Company Report #CTU 252650 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Risperdal 2 Mg Initial or Prolonged Depressed Level Of Jannsen PS Jannsen ORAL 1 DAILY Required Consciousness ORAL Intervention to Dizziness Lasix C Prevent Permanent Mental Status Changes Zoloft C Impairment/Damage Flonase C Date:07/07/05ISR Number: 4708039-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050606856 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal PS OROPHARINGEAL Initial or Prolonged Oedema Peripheral Risperdal SS OROPHARINGEAL Stasis Dermatitis Tavor C OROPHARINGEAL Xanef C OROPHARINGEAL Lanitop C OROPHARINGEAL Taxilan I OROPHARINGEAL Date:07/07/05ISR Number: 4708040-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050606498 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal PS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2589 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/07/05ISR Number: 4708402-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050607288 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal Consta PS INTRAMUSCULAR Date:07/07/05ISR Number: 4708403-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050607506 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Homicidal Ideation Risperdal PS OROPHARINGEAL Physical Assault Date:07/07/05ISR Number: 4709038-8Report Type:Expedited (15-DaCompany Report #2005079018 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Lithium Initial or Prolonged Apathy Literature (Lithium) PS ORAL 750 MG (250 Confusional State Health MG, 3 IN 1 D) Dehydration Professional Levomepromazine Diarrhoea Other Drug Clearance Decreased (Levomepromazine) SS 6.25 MG Drug Ineffective Lisinopril Drug Interaction Dysarthria (Lisinopril) SS 30 MG General Physical Health Risperidone Deterioration (Risperidone) SS 0.5 MG (0.25 Glasgow Coma Scale MG, 2 IN 1 D) Abnormal Escitalopram Lethargy (Escitalopram) SS 10 MG Neurological Symptom Irbesartan Neurotoxicity (Irbesartan) SS 300 MG Oliguria Lormetazepam Overdose (Lormetazepam) C Renal Impairment Metformin Somnolence (Metformin) C Therapeutic Agent Furosemide Toxicity (Furosemide) C Tremor Repaglinide (Repaglinide) C Spironolactone (Spironolactone) C Date:07/07/05ISR Number: 4709094-7Report Type:Direct Company Report #CTU 252737 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Perineal Pain Risperdal 4mg Priapism Janssen PS Janssen ORAL 4MG BID ORAL Haloperidol Decanoate C Haloperidol C Inderal C Valium C Cogentin C 22-Feb-2006 08:20 AM Page: 2590 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/07/05ISR Number: 4710635-4Report Type:Expedited (15-DaCompany Report #2005079018 Age:74 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Lithium (Lithium) PS 750 MG (250 Initial or Prolonged Apathy Literature MG, 3 IN 1 D) Blood Creatinine Health Levomepromazine Increased Professional (Levomeprolazine) SS 6.25 MG Confusional State Lisinopril Creatinine Renal (Lisinopril) SS 30 MG Clearance Decreased Risperidone Dehydration (Risperidone) SS 0.5 MG (0.25 Diarrhoea MG, 2 IN 1 D) Drug Interaction Escitalopram Dysarthria (Escitalopram) SS 10 MG General Physical Health Irbesartan Deterioration (Irbesartan) SS 300 MG Glasgow Coma Scale Lormetazepam Abnormal (Lormetazepam) C Lethargy Metformin Neurotoxicity (Metformin) C Oliguria Furosemide Overdose (Furosemide) C Renal Impairment Repaglinide Somnolence (Repaglinide) C Therapeutic Agent Spironolactone Toxicity (Spironolactone) C Therapy Non-Responder Tremor Date:07/08/05ISR Number: 4709174-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050105227 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperdal PS OROPHARINGEAL Initial or Prolonged Phosphokinase Increased Lithium Carbonate C 10 years Other Blood Pressure Carbamazepine C Fluctuation Body Temperature Increased Catatonia Heart Rate Irregular Hypomania Respiratory Disorder White Blood Cell Count Increased Date:07/08/05ISR Number: 4709175-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050606891 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Risperdal Consta PS INTRAMUSCULAR Dipiperon SS OROPHARINGEAL taken at 18.00hrs Dipiperon SS OROPHARINGEAL Dipiperon SS OROPHARINGEAL Laubeel SS OROPHARINGEAL Laubeel SS OROPHARINGEAL Laubeel SS OROPHARINGEAL Olanzapine SS OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2591 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/05ISR Number: 4709176-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050402219 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Risperdal Consta PS INTRAMUSCULAR 71 DAY Drug Exposure During Pregnancy Date:07/08/05ISR Number: 4709177-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040501364 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acne Risperdal PS OROPHARINGEAL Blood Prolactin Increased Risperdal SS OROPHARINGEAL Constipation Risperdal SS OROPHARINGEAL Decreased Appetite Wellbutrin C Delusion Depression Diarrhoea Disturbance In Attention Galactorrhoea Gastric Polyps Hallucination Headache Hepatic Lesion Infertility Insomnia Malaise Memory Impairment Panic Attack Paranoia Pituitary Tumour Benign Vision Blurred Visual Disturbance Weight Decreased Date:07/08/05ISR Number: 4709852-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050606818 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Spasms Haldol PS INTRAMUSCULAR Oculogyration Haldol SS INTRAMUSCULAR Oropharyngeal Spasm Haldol Decanoate SS INTRAMUSCULAR Risperdal SS OROPHARINGEAL patient received between 2 and 4 mg Risperdal SS OROPHARINGEAL Risperdal SS OROPHARINGEAL Haldol Decanoate SS INTRAMUSCULAR Haldol SS INTRAMUSCULAR Haldol C OROPHARINGEAL 5 to 10mg as needed. Haldol C OROPHARINGEAL Tegretal C OROPHARINGEAL Eunerpan C OROPHARINGEAL Akineton C OROPHARINGEAL 22-Feb-2006 08:20 AM Page: 2592 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/08/05ISR Number: 4709857-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050606652 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Extrapyramidal Disorder Risperdal Consta PS INTRAMUSCULAR General Physical Health Risperdal Consta SS INTRAMUSCULAR Deterioration Risperdal SS UNKNOWN Haematemesis Risperdal SS UNKNOWN Risperdal SS UNKNOWN Risperdal SS UNKNOWN Planum C UNKNOWN Pantozol C UNKNOWN Date:07/08/05ISR Number: 4709858-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050606946 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aspartate Risperdal PS OROPHARINGEAL Aminotransferase Leponex SS OROPHARINGEAL Increased Leponex SS OROPHARINGEAL Rhabdomyolysis Leponex SS OROPHARINGEAL Orfiril C OROPHARINGEAL Resonium C OROPHARINGEAL Date:07/11/05ISR Number: 4710459-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050606693 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Generalised Risperdal PS OROPHARINGEAL Initial or Prolonged Exanthematous Pustulosis Depamide SS UNKNOWN Atarax C Dafalgan C Stilnox C Date:07/11/05ISR Number: 4710460-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050607218 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Risperdal Consta PS INTRAMUSCULAR Since 1.5 yrs Excitability Hypertension Hyperventilation Date:07/11/05ISR Number: 4710461-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050700013 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal Consta PS INTRAMUSCULAR Phosphokinase Increased Catatonia Hypertension Pyrexia 22-Feb-2006 08:20 AM Page: 2593 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/11/05ISR Number: 4710462-8Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20050700224 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Incorrect Dose Risperdal Consta PS Administered Seroquel C White Blood Cell Count Evening Primrose Oil C Decreased Date:07/11/05ISR Number: 4710463-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050700451 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Risperdal PS OROPHARINGEAL 64 DAY Risperdal SS OROPHARINGEAL 64 DAY Magnesium Oxide C OROPHARINGEAL 318 DAY Imidapril Hydrochloride C OROPHARINGEAL 93 DAY Imidapril Hydrochloride C OROPHARINGEAL 93 DAY Dimeticone C OROPHARINGEAL 64 DAY Date:07/11/05ISR Number: 4710464-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050700874 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Increased Risperdal Consta PS INTRAMUSCULAR Injection Site Risperdal Consta SS INTRAMUSCULAR Haemorrhage Zoloft C Thrombocytopenia Date:07/11/05ISR Number: 4712933-7Report Type:Expedited (15-DaCompany Report #A044-002-005670 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Foreign Aricept (Donepezil Initial or Prolonged Dermatosis Health Hydrochloride) PS ORAL 10 MG, 1 IN 1 Disorientation Professional D, ORAL Incoherent Atarax (Hydroxyzine Pemphigoid Hydrochloride) SS ORAL 25 MG, 1 IN 1 Pyrexia D, ORAL Lepticur (Tropatepine Hydrochloride) SS ORAL ORAL Risperdal (Risperidone) SS ORAL 2 MG, 1 IN 1 D, ORAL Date:07/12/05ISR Number: 4712048-8Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20050700160 Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperdal PS OROPHARINGEAL 2mg to Insulin-Dependent 4mg/day Diabetic Ketoacidosis Valproate C Lithium C 22-Feb-2006 08:20 AM Page: 2594 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/12/05ISR Number: 4712049-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050700295 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal PS OROPHARINGEAL Decreased Risperdal SS OROPHARINGEAL Date:07/12/05ISR Number: 4712050-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050700877 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cervix Carcinoma Stage Risperdal PS OROPHARINGEAL Iii Risperdal SS OROPHARINGEAL Metastases To Lymph Nodes Seroquel C Vaginal Haemorrhage Zoloft C Date:07/12/05ISR Number: 4712198-6Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12824587 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyponatraemia Risperidone PS ORAL Polydipsia Psychogenic Ativan C Rivotril C Date:07/12/05ISR Number: 4712789-2Report Type:Direct Company Report #CTU 252989 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Cymbalta PS 60 MG Drug Dose Omission Risperdal SS 0.25 MG Nightmare Treatment Noncompliance Unevaluable Event Date:07/12/05ISR Number: 4713097-6Report Type:Direct Company Report #CTU 253095 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dysphagia Risperidone PS ORAL 2 MG, 1 MG Initial or Prolonged Mental Status Changes BID, ORAL Required Memantine C Intervention to Donepezil C Prevent Permanent Loratadine C Impairment/Damage Levothyroxine Na (Synthroid) C Clopidogrel Bisulfate C Simvastatin C Metoprolol C Date:07/12/05ISR Number: 4713481-0Report Type:Expedited (15-DaCompany Report #2005S1005413 Age:36 YR Gender:Female I/FU:I Outcome PT Life-Threatening Disease Recurrence Hospitalization - Drug Ineffective Initial or Prolonged Intentional Misuse 22-Feb-2006 08:20 AM Page: 2595 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Overdose Schizophrenia Report Source Product Role Manufacturer Route Dose Duration Study Risperidone PS ORAL SEE IMAGE, PO Health Lorazepam SS ORAL 2 MG; QD; PO Professional Benzatropine Other Mesilate C Date:07/13/05ISR Number: 4713379-8Report Type:Expedited (15-DaCompany Report #PHNU2005DE01675 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Echocardiogram Abnormal Leponex / Clozaril Fatigue (Clozapine) PS Novartis Sector: Hypertensive Crisis Pharma ORAL 150 mg/day 77760MIN Ventricular Hypertrophy Risperdal SS ORAL 6 mg/day Weight Increased Akineton /Sch/ SS Haldol SS Tavor SS Date:07/13/05ISR Number: 4713523-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050700386 Age:50 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspepsia Risperdal PS OROPHARINGEAL Neutropenia Prozac C Weight Decreased Date:07/13/05ISR Number: 4713524-4Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050601159 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal Consta PS OTHER Psychiatric Symptom Date:07/13/05ISR Number: 4713525-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041204782 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Risperdal PS OROPHARINGEAL 892 DAY Initial or Prolonged Hepatitis Acute Pimozide SS 892 DAY Other Biperiden Hydrochloride SS OROPHARINGEAL 892 DAY Clarithromycin C Chlorpheniramine Maleate C Bromhexine Hydrochloride C Proceterol Hydrochloride C 22-Feb-2006 08:20 AM Page: 2596 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/13/05ISR Number: 4713526-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050701443 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Anorexia Risperdal Consta SS INTRAMUSCULAR Dyskinesia Risperdal SS OROPHARINGEAL Feeling Abnormal Risperdal SS OROPHARINGEAL Panic Attack Date:07/13/05ISR Number: 4713527-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050507448 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Risperdal PS OROPHARINGEAL Initial or Prolonged Sennoside C OROPHARINGEAL Other Ferrous Sulfate C OROPHARINGEAL Date:07/14/05ISR Number: 4714276-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050701519 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Deep Vein Thrombosis Risperdal Consta PS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Date:07/14/05ISR Number: 4714277-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050607156 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal PS OROPHARINGEAL Phosphokinase Increased Haloperidol SS Bradykinesia Parkinsonism Date:07/14/05ISR Number: 4714506-9Report Type:Expedited (15-DaCompany Report #200516287GDDC Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Daunorubicin PS Aventis Electrocardiogram Qt Pharmaceuticals Inc. Prolonged Risperdal SS ORAL Sinus Bradycardia Antra C ORAL Zofran C Endoxan C Asparaginase C Puri-Nethol C Methotrexate C Cotrimoxazol C Cytosar C Dexamethasone C Oncovin C Meronem C Teicoplanin C Rasburicase C 22-Feb-2006 08:20 AM Page: 2597 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/14/05ISR Number: 4716648-0Report Type:Expedited (15-DaCompany Report #2004106748 Age:29 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Consumer Neurontin (Tablets) Initial or Prolonged Aggression (Gabapentin) PS 900 MG (300 Other Agitation MG, 3 IN 1 D) Condition Aggravated Neurontin Delusion (Gabapentin) SS 900 MG (300 Depression MG, 3 IN 1 D) Drug Ineffective Haldol (Haloperidol) SS Hallucination, Auditory Risperidone Hallucination, Visual (Risperidone) SS 6 MG (3 MG, 2 Homicidal Ideation IN 1 D) Intentional Misuse Seroquel (Quetiapine Lethargy Fumarate) C Multiple Drug Overdose Metformin Psychotic Disorder (Metformin) C Refusal Of Treatment By Patient Somnolence Stress Suicidal Ideation Suicide Attempt Treatment Noncompliance Date:07/15/05ISR Number: 4714843-8Report Type:Expedited (15-DaCompany Report #US-SOLVAY-00305002231 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dose Omission Fluvoxamine PS UNKNOWN Daily dose: Initial or Prolonged Dystonia unknown Extrapyramidal Disorder Fluvoxamine SS UNKNOWN Daily dose: Neurotransmitter Level 300 Altered milligram(s) Methylphenidate SS UNKNOWN Daily dose: 36 milligram(s) Risperidone SS UNKNOWN Daily dose: 1.5 milligram(s) Methylphenidate SS UNKNOWN Daily dose: 54 milligram(s) Guanfacine C UNKNOWN Daily dose: 2 milligram(s) Date:07/15/05ISR Number: 4714888-8Report Type:Expedited (15-DaCompany Report #PHBS2003JP05267 Age:87 YR Gender:Female I/FU:F Outcome PT Hospitalization - Anuria Initial or Prolonged Blood Creatine Phosphokinase Increased Delirium Depressed Level Of Consciousness Disorientation Hallucination, Visual Neuroleptic Malignant 22-Feb-2006 08:20 AM Page: 2598 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Syndrome Phonological Disorder Salivary Hypersecretion Somatic Delusion Report Source Product Role Manufacturer Route Dose Duration Tremor Imipramine PS Novartis Sector: Urinary Retention Pharma Anafranil SS ORAL 75 mg/day 10080MIN Anafranil SS ORAL 150 mg/day 5760 MIN Anafranil SS ORAL 100 mg/day 8640 MIN Anafranil SS ORAL 50 mg/day 5760 MIN Anafranil SS ORAL 30 mg/day 2880 MIN Anafranil SS ORAL 50 mg/d 5760 MIN Anafranil SS ORAL 75 mg/d Draganon SS UNKNOWN 600 mg/day 8640 MIN Bromocriptine Mesylate SS Gramalil SS UNKNOWN 150 mg/day Risperdal SS UNKNOWN 1 mg/day Magnesium Oxide C ORAL 0.6 g/day Trazodone C Hydroxyzine C 20 mg, QHS Fluvoxamine C Pursennid C ORAL 12 mg/day Loxoprofen C Tizanidine C Date:07/15/05ISR Number: 4714941-9Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20050701321 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemorrhage Subcutaneous Risperdal PS ORAL Date:07/15/05ISR Number: 4714942-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050604820 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Retinal Vascular Risperdal Consta PS INTRAMUSCULAR Other Occlusion Date:07/15/05ISR Number: 4714943-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050103377 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Pulmonary Oedema Risperdal Consta PS INTRAMUSCULAR Arrhythmia Risperdal Consta SS INTRAMUSCULAR Bile Duct Obstruction Risperdal SS ORAL Cardiac Arrest Risperdal SS ORAL Liver Function Test Risperdal SS ORAL Abnormal Risperdal Consta SS INTRAMUSCULAR Physical Assault Psychotic Disorder Date:07/15/05ISR Number: 4714944-4Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20050606947 Age:42 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Hypotension Risperdal Consta PS INTRAMUSCULAR Other Syncope Vasovagal Flufenazin SS 22-Feb-2006 08:20 AM Page: 2599 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phenprobamate SS Date:07/15/05ISR Number: 4715035-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050500365 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal PS ORAL Trazodone C Clonazepam C as needed Benztropine C Date:07/15/05ISR Number: 4715083-9Report Type:Expedited (15-DaCompany Report #FR-SANOFI-SYNTHELABO-A02200501790 Age:67 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Stilnox PS ORAL UNK Initial or Prolonged Orthostatic Hypotension Teralithe SS ORAL Vertigo Risperdal SS ORAL Levothyrox C ORAL Titanoreine C RECTAL UNK Daflon C ORAL 1500 mg 4 DAY Date:07/18/05ISR Number: 4715824-0Report Type:Expedited (15-DaCompany Report #2005UW10303 Age:17116 DYGender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Seroquel PS Zeneca Initial or Prolonged Disorientation Pharmaceutical ORAL 1 DAY Seroquel SS Zeneca Pharmaceutical ORAL 266 DAY Risperidone SS INTRAMUSCULAR Lithium C ORAL Depakote C ORAL Premarin C ORAL Levothroid C ORAL Flexeril C Lunesta C Date:07/18/05ISR Number: 4716084-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050701030 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Risperdal PS ORAL 1/2 dose in Hospitalization - Hypervolaemia morning and Initial or Prolonged Hyponatraemia evening (1/2 Inappropriate - 0- 1/2) Antidiuretic Hormone Metoprolol C ORAL Secretion Thiamazol C ORAL Date:07/18/05ISR Number: 4716085-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050701031 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS ORAL 22-Feb-2006 08:20 AM Page: 2600 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/18/05ISR Number: 4716086-0Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050701159 Age:94 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Risperdal PS ORAL (0.5 mg in Initial or Prolonged the morning Other and 1.5 mg at night) Risperdal SS ORAL Diuretic C UNKNOWN Avanza C UNKNOWN Date:07/18/05ISR Number: 4716087-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050702005 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Risperdal PS Corrected Interval Prolonged Date:07/18/05ISR Number: 4716088-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050702671 Age:28 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytoclastic Risperdal PS ORAL Vasculitis Date:07/18/05ISR Number: 4717818-8Report Type:Direct Company Report #CTU 253495 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Risperadal PS Dysphagia Gait Disturbance Hyperhidrosis Hypotension Incontinence Malaise Pneumonia Aspiration Pyrexia Renal Failure Speech Disorder Date:07/18/05ISR Number: 4718124-8Report Type:Direct Company Report #CTU 253419 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Risperdal PS Janssen Pharmaceuticals Date:07/18/05ISR Number: 4718324-7Report Type:Direct Company Report #CTU 253450 Age:29 YR Gender:Male I/FU:I Outcome PT Hospitalization - Agitation Initial or Prolonged Disorientation Grand Mal Convulsion 22-Feb-2006 08:20 AM Page: 2601 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lethargy Neuroleptic Malignant Syndrome Report Source Product Role Manufacturer Route Dose Duration Pyrexia Clozapine PS ORAL ORAL Rhabdomyolysis Risperidone SS ORAL ORAL Date:07/19/05ISR Number: 4716725-4Report Type:Expedited (15-DaCompany Report #2005UW10385 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Seroquel PS Zeneca Increased Pharmaceutical ORAL Jaundice Seroquel SS Zeneca Liver Function Test Pharmaceutical ORAL Abnormal Risperdal SS Risperdal SS Singulair SS Remeron SS Methadone SS Date:07/19/05ISR Number: 4717004-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050606243 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebellar Atrophy Risperdal Consta PS INTRAMUSCULAR Gait Disturbance Risperdal Consta SS INTRAMUSCULAR Poverty Of Speech Fluanxol Depot 2% SS INTRAMUSCULAR Dose started Schizophrenia, Paranoid 25 years ago Type Haldol-Janssen C started 28 years ago Seroquel C ORAL Dose = up to 400 mg given intermittentl y Date:07/19/05ISR Number: 4717005-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050204934 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardio-Respiratory Arrest Risperdal PS 1-3mg Dyspnoea Risperdal SS Loss Of Consciousness Truxal SS Right Ventricular Failure Truxal SS Syncope Tavor SS Eunerpan SS Eunerpan SS Eunerpan SS Timonil SS Delix 2.5 Plus C Delix 2.5 Plus C Ass C Ismo C Dytide H C Dytide H C 1 tbl. 22-Feb-2006 08:20 AM Page: 2602 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/19/05ISR Number: 4717214-3Report Type:Expedited (15-DaCompany Report #PHNU2005DE02527 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hodgkin'S Disease Leponex / Clozaril Laryngospasm (Clozapine) PS Novartis Sector: Leukopenia Pharma ORAL Lymphadenopathy Olanzapine SS ORAL 30 mg/day Oculogyration Risperidone SS ORAL 6 mg/day Pyrexia Aripiprazole SS ORAL 10 mg/day Date:07/20/05ISR Number: 4718347-8Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20050701940 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal PS ORAL 3 YR Initial or Prolonged Electrocardiogram Qt Antra C ORAL long term use Prolonged Zofran C Sinus Bradycardia Asparaginase C Methotrexat C Cotrimoxazol C Dexamethason C Meronem C Rasburicase C Teicoplanin C Oncovin C Cytosar C Cotrimoxazol C Puri-Nethol C Endoxan C Daunorubicin I cyclic therapy 4 DAY Date:07/20/05ISR Number: 4724530-8Report Type:Direct Company Report #CTU 253705 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Agoraphobia Risperdal PS 4 MG DAILY Alopecia Wellbutrin C Anxiety Benadryl C Balance Disorder Coordination Abnormal Dysphagia Feeling Abnormal Hemiplegia Insomnia Memory Impairment Menorrhagia Nightmare Ovarian Neoplasm Panic Disorder Speech Disorder Uterine Neoplasm Visual Acuity Reduced Visual Disturbance 22-Feb-2006 08:20 AM Page: 2603 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/05ISR Number: 4720235-8Report Type:Expedited (15-DaCompany Report #AT-JNJFOC-20050701941 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal PS 38 DAY Initial or Prolonged Oedema Peripheral Risperdal SS 38 DAY Risperdal SS 38 DAY Xanor C Xanor C Xanor C Xanor C Xanor C Xanor C Akineton Ret C Nozinan C Truxal C Trittico C Xanor C Xanor C Quilonorm I Quilonorm I Quilonorm I Quilonorm I Quilonorm I Quilonorm I Date:07/21/05ISR Number: 4720236-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050701525 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Pulmonary Oedema Risperdal PS ORAL Rash Erythematous Pyostacine C Date:07/21/05ISR Number: 4720237-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050702413 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Risperdal PS Eyelid Margin Crusting Lamictal SS ORAL (prescribed Headache as once Hemiparesis daily, taken Musculoskeletal Stiffness as twice Nausea daily) Sputum Discoloured Lamictal SS ORAL Treatment Noncompliance Methadone SS (taken by patient at a dose higher than prescribed) Date:07/21/05ISR Number: 4720238-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050702431 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Impairment Risperdal Consta PS 22-Feb-2006 08:20 AM Page: 2604 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/21/05ISR Number: 4720657-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050703584 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal PS ORAL Phosphokinase Increased Risperdal SS ORAL Haldol SS INTRAVENOUS Carbamazepine C Biperiden Hydrochloride C Levomepromazine Maleate C Date:07/22/05ISR Number: 4721904-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050702445 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Compartment Syndrome Risperdal PS Initial or Prolonged Drug Interaction Clonazepam C Muscle Necrosis Simvastatin I Rhabdomyolysis Date:07/22/05ISR Number: 4721943-5Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12784211 Age:43 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Risperidone PS ORAL Initial or Prolonged Anxiety Disorder Floxyfral C Asthenia Alprazolam (Gen) C Vomiting Date:07/22/05ISR Number: 4722534-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050600355 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Ganglioneuroma Other Date:07/22/05ISR Number: 4725838-2Report Type:Direct Company Report #CTU 254112 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cogwheel Rigidity Risperdal M-Tab 1 Mg Tremor Janssen PS Janssen ORAL 3 MG Q 12 PO Divalproex Sodium C Insulin C Diphenhydramine C Flupherazine C Hydroxyzine C Zeprasidone C 22-Feb-2006 08:20 AM Page: 2605 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/25/05ISR Number: 4723778-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050606818 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Spasms Haloperidol PS ORAL Oculogyration Haloperidol SS ORAL 5-10 mg as Oropharyngeal Spasm needed Haloperidol SS ORAL Haldol Decanoate SS INTRAMUSCULAR concentration : 50 mg/ml Risperdal SS ORAL Risperdal SS ORAL Risperdal SS ORAL patient received between 2 and 4 mg Haldol Decanoate SS INTRAMUSCULAR concentration : 50 mg/ml Haloperidol SS ORAL Tegretal C ORAL Eunerpan C ORAL Akineton C ORAL Date:07/25/05ISR Number: 4723779-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050405482 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Blood Creatine Risperdal Consta SS INTRAMUSCULAR Other Phosphokinase Increased Risperdal SS ORAL Chest Pain Coronary Artery Disease Electrocardiogram Change Electrocardiogram Qt Corrected Interval Prolonged Helicobacter Gastritis Palpitations Supraventricular Tachycardia Ventricular Hypokinesia Date:07/25/05ISR Number: 4723780-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050702814 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal Consta PS INTRAMUSCULAR Breast Cancer Breast Discharge Date:07/25/05ISR Number: 4723781-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041101099 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Abortion Spontaneous Initial or Prolonged Diabetes Mellitus Other Non-Insulin-Dependent Drug Exposure During Pregnancy 22-Feb-2006 08:20 AM Page: 2606 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypoaesthesia Report Source Product Role Manufacturer Route Dose Duration Risperdal PS ORAL 6 YR Risperdal SS ORAL 6 YR Benadryl C ORAL Lorazepam C ORAL Diovan C ORAL Date:07/25/05ISR Number: 4723783-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050703088 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Liver Function Test Risperdal PS ORAL Initial or Prolonged Abnormal Risperdal SS ORAL Otitis Media Adderall Xr C ORAL Pyrexia Adderall Xr C ORAL Sedation Adderall Xr C ORAL White Blood Cell Count Adderall Xr C ORAL Decreased Date:07/25/05ISR Number: 4723784-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050704266 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Risperdal Consta PS Prolonged Date:07/25/05ISR Number: 4723980-3Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0305917-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Depakote Tablets PS ORAL Non-Insulin-Dependent Depakote Tablets SS Risperidone SS ORAL Prazepam C ORAL Paroxetine Hydrochloride C ORAL Vaseretic C ORAL Domperidone C ORAL Fenofibrate C ORAL Acamprosate C ORAL Alprazolam C ORAL Date:07/25/05ISR Number: 4725330-5Report Type:Expedited (15-DaCompany Report #2005-BP-11588RO Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Health Methadone Hcl Eyelid Margin Crusting Professional Tablets Usp, 10 Mg Headache (Methadone Hemiparesis Hydrochloride) PS Musculoskeletal Stiffness Lamictal Nausea (Lamitrigine) SS ORAL PO Sputum Discoloured Risperidone Torticollis (Risperidone) SS Treatment Noncompliance 22-Feb-2006 08:20 AM Page: 2607 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/05ISR Number: 4724839-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050504633 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Deep Vein Thrombosis Risperdal Consta PS INTRAMUSCULAR Pulmonary Embolism Risperdal Consta SS INTRAMUSCULAR Clonazepam C Vistaril C Seroquel C Seroquel C Depakote C Cogentin C Effexor C Date:07/26/05ISR Number: 4724841-6Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050703851 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Risperdal Consta PS INTRAMUSCULAR Risperdal C ORAL Date:07/26/05ISR Number: 4724842-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050703997 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Temperature Intolerance Risperdal PS Date:07/26/05ISR Number: 4725119-7Report Type:Expedited (15-DaCompany Report #GXKR2005US01328 Age:15 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Literature Bupropion Initial or Prolonged Confusional State Health (Ngx)(Bupropion) PS 150 MG, BID 61 DAY Convulsion Professional Risperidone (Ngx) Depression (Risperidone) SS 0.25 MG, BID 213 DAY Drug Interaction Atomoxetine Dry Mouth (Atomoxetine) SS INTENTIONAL Electrocardiogram Qt OVERDOSE OF Corrected Interval 1200 MG Prolonged Alprazolam Heart Rate Increased (Alprazolam) C Intentional Misuse Overdose Postictal State Tremor Date:07/27/05ISR Number: 4726015-1Report Type:Periodic Company Report #FR-JNJFOC-20050405079 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coagulopathy Risperdal Consta PS INTRAMUSCULAR 22-Feb-2006 08:20 AM Page: 2608 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/05ISR Number: 4726016-3Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050703864 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS Date:07/27/05ISR Number: 4726017-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050704047 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperdal PS ORAL Omeprazole C ORAL Date:07/27/05ISR Number: 4726018-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050704140 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Arrhythmia Risperdal PS ORAL Cerebral Infarction Risperdal SS ORAL Haldol SS Levomepromazine Maleate C ORAL 5-25 mg per day Flunitrazepam C ORAL Date:07/28/05ISR Number: 4727093-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050703599 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Risperdal PS ORAL taken for Drug Exposure During several years Pregnancy Date:07/28/05ISR Number: 4727094-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050704141 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pulmonary Embolism Risperdal PS ORAL 5 DAY Hospitalization - Rhabdomyolysis Risperdal SS ORAL 5 DAY Initial or Prolonged Biperiden Hydrochloride C Estazolam C Flunitrazepam C Lithium Carbonate C Lithium Carbonate C Date:07/28/05ISR Number: 4727095-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050704504 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Risperdal PS ORAL Initial or Prolonged Diabetes Mellitus Medazepam SS ORAL Femoral Neck Fracture Flunitrazepam SS ORAL Isosorbide Dinitrate C ORAL Dipyridamole C ORAL Digoxin C ORAL Furosemide C ORAL 22-Feb-2006 08:20 AM Page: 2609 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Voglibose C ORAL Levomepromazine Maleate C ORAL Date:07/28/05ISR Number: 4727096-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050603225 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Iron Decreased Risperdal PS ORAL 17 DAY Initial or Prolonged C-Reactive Protein Nicardipine Increased Hydrochloride C ORAL Lung Neoplasm Malignant Pantethine C ORAL Supraventricular Bromvalerylurea C ORAL Extrasystoles Lorazepam C ORAL Theophylline C ORAL Fenoterol Hydrobromide C ORAL Ambroxol Hydrochloride C ORAL Clonazepam C ORAL Amlodipine Besilate C ORAL Sodium Picosulfate C ORAL Sennoside C ORAL Date:07/28/05ISR Number: 4727098-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050504878 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Decreased Appetite Risperdal PS ORAL Initial or Prolonged Gait Disturbance Risperdal SS ORAL 0-2 mg daily Other Parkinsonism prn Rhabdomyolysis Risperdal SS ORAL Risperdal SS ORAL Risperdal SS ORAL Risperdal SS ORAL prn Zopiclone C Zopiclone C prn Lovastatin C Donezepil C d/c in Jul-04 Trazodone C Date:07/28/05ISR Number: 4727553-8Report Type:Direct Company Report #CTU 254654 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Triglycerides Risperidone 4mg Increased Jannsen PS Jannsen ORAL 4MG BID Glucose Tolerance ORAL Impaired Fenofibrate C Hyperglycaemia Ziprasidone C Ketonuria 22-Feb-2006 08:20 AM Page: 2610 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/29/05ISR Number: 4728083-XReport Type:Expedited (15-DaCompany Report #PHBS2003US04724 Age:22 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Breast Tenderness Clozapine PS Novartis Sector: Initial or Prolonged Chest Discomfort Pharma UNKNOWN 25 mg/d Diabetic Ketoacidosis Clozapine SS Novartis Sector: Dyspnoea Pharma UNKNOWN 125 mg/d Hyperventilation Clozapine SS Novartis Sector: Lethargy Pharma UNKNOWN 150 mg/d Menstrual Disorder Risperidone (Ngx) SS UNKNOWN 2 mg/d Nausea Risperidone (Ngx) SS UNKNOWN 5 mg/d Vomiting Risperidone (Ngx) SS UNKNOWN 5 mg/d Weight Decreased Lorazepam C UNKNOWN 3 mg/d Benztropeine C UNKNOWN 2 mg/d Benztropeine C UNKNOWN 1 mg/d Multivitamins C UNKNOWN Calcium C UNKNOWN Date:07/29/05ISR Number: 4728540-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050705166 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Extrapyramidal Disorder Concerta PS ORAL Hospitalization - Suicide Attempt Concerta SS ORAL Initial or Prolonged Risperidone SS ORAL Other Risperidone SS ORAL Guanfacine C Fluvoxamine C Date:07/29/05ISR Number: 4729329-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050703603 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Risperdal PS Initial or Prolonged Malaise Parkinsonism Respiration Abnormal Date:07/29/05ISR Number: 4729330-0Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20050705927 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertensive Crisis Risperdal Consta PS INTRAMUSCULAR Psychotic Disorder Date:07/29/05ISR Number: 4733750-8Report Type:Expedited (15-DaCompany Report #2005-BP-11853RO Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Foreign Citalopram Anger Literature (Citalopram Condition Aggravated Health Hydrobromide) PS Excitability Professional Methylpenidate Hypomania (Methylphenidate) SS 20 MG Initial Insomnia Venlafaxine Irritability (Venlafaxine) SS 300 MG Verbal Abuse Risperidone 22-Feb-2006 08:20 AM Page: 2611 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) SS 0.5 MG Ramipril (Ramipril) C Date:07/29/05ISR Number: 4734152-0Report Type:Expedited (15-DaCompany Report #2005104854 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abasia Consumer Geodon (Ziprasidone) PS ORAL 120 MG (60 Adverse Drug Reaction MG, 2 IN 1 Alcoholism D), ORAL Anxiety Neurontin Arthritis (Gabapentin) SS ORAL ORAL Attention Risperdal Deficit/Hyperactivity (Risperidone) SS Disorder Klonopin Bipolar Disorder (Clonazepam) C Cartilage Injury Flexeril Condition Aggravated (Cyclobenzaprine Disturbance In Attention Hydrochloride) C Drug Dose Omission Metoprolol Gait Disturbance (Metoprolol) C Heart Rate Increased Hyoscyamine Psychomotor Hyperactivity (Hyoscyamine) C Refusal Of Treatment By Patient Tendonitis Thinking Abnormal Weight Increased Date:08/01/05ISR Number: 4730232-4Report Type:Expedited (15-DaCompany Report #KR-JNJFOC-20050703279 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Reminyl PS ORAL 36 DAY Drug Interaction Risperidone SS ORAL 66 DAY Pneumonia Aspiration Stilnox SS ORAL 14 DAY Stupor Plavix SS ORAL 70 DAY Date:08/01/05ISR Number: 4730233-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050703601 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Laboratory Test Risperdal PS ORAL Interference Phaeochromocytoma Date:08/01/05ISR Number: 4730234-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050704712 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Risperdal PS TRANSPLACENTAL 1 Dose = 1 Initial or Prolonged Pregnancy Tablet 39 DAY Congenital Anomaly Premature Baby Deroxat C 1 Dose = 1 Pyelectasia Tablet 22-Feb-2006 08:20 AM Page: 2612 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/05ISR Number: 4730235-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050502386 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Risperdal Consta PS INTRAMUSCULAR Date:08/01/05ISR Number: 4730236-1Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20050705927 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertensive Crisis Risperdal Consta PS INTRAMUSCULAR Psychotic Disorder Date:08/01/05ISR Number: 4730237-3Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20050705929 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertensive Crisis Risperdal Consta PS INTRAMUSCULAR Risperdal SS ORAL Lithium Carbonate C ORAL Quetiapine C ORAL Date:08/01/05ISR Number: 4730314-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050704036 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Vascular Risperdal PS ORAL Thrombosis Date:08/01/05ISR Number: 4732485-5Report Type:Direct Company Report #CTU 254838 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dysarthria Risperidone PS ORAL 3 MG PO Q DAY Tardive Dyskinesia Tongue Disorder Date:08/01/05ISR Number: 4733098-1Report Type:Direct Company Report #CTU 254839 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Risperdal 1mg Po X 1 Obstructive Airways Dose PS ORAL 1MG ORAL Disorder Posture Abnormal Restlessness Date:08/02/05ISR Number: 4731638-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050704912 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Risperdal PS ORAL Atrial Fibrillation Zoloft SS ORAL Prothrombin Time Zoloft SS ORAL Prolonged Zoloft SS ORAL Zoloft SS ORAL 22-Feb-2006 08:20 AM Page: 2613 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aricept C ORAL 4 DAY Delix C ORAL Sortis C ORAL Unat C ORAL Pantozol C ORAL Date:08/02/05ISR Number: 4731639-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050704918 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperdal PS ORAL Insulin-Dependent Taxilan C ORAL Ketoacidosis Akineton C ORAL Date:08/02/05ISR Number: 4731641-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031004734 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Risperdal PS ORAL dose= tablet Pregnancy Deroxat C dose=tablet Premature Labour Premature Rupture Of Membranes Date:08/02/05ISR Number: 4731643-3Report Type:Expedited (15-DaCompany Report #AT-JNJFOC-20050701941 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal PS 38 DAY Initial or Prolonged Oedema Peripheral Risperdal SS 38 DAY Risperdal SS 38 DAY Xanor C Xanor C Xanor C Xanor C Xanor C Xanor C Akineton Ret C Nozinan C Truxal C Trittico C Xanor C Xanor C Quilonorm I Quilonorm I Quilonorm I Quilonorm I Quilonorm I Quilonorm I Date:08/02/05ISR Number: 4731644-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050502005 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Risperidone PS ORAL Initial or Prolonged Drug Exposure During Risperidone SS ORAL Other Pregnancy Trihexyphenidyl 22-Feb-2006 08:20 AM Page: 2614 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride SS ORAL Risperidone SS ORAL Date:08/02/05ISR Number: 4731645-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050601922 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthma Risperdal Consta PS INTRAMUSCULAR Hospitalization - Cardiac Arrest Orfiril C ORAL Since 20 Initial or Prolonged Respiratory Arrest Insulin C SUBCUTANEOUS Melperone C ORAL Date:08/03/05ISR Number: 4732474-0Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050705215 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Risperdal PS ORAL Breast Cancer Female Risperdal SS ORAL Date:08/03/05ISR Number: 4732475-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050706101 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anorexia Risperdal Consta PS INTRAMUSCULAR 2 MON Cardiovascular Disorder Failure To Thrive Lethargy Oedema Peripheral Protein Total Decreased Weight Decreased Date:08/03/05ISR Number: 4732476-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050700874 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Increased Risperdal Consta PS INTRAMUSCULAR Injection Site Risperdal Consta SS INTRAMUSCULAR Haemorrhage Zoloft C Thrombocytopenia Date:08/03/05ISR Number: 4733428-0Report Type:Periodic Company Report #US-JNJFOC-20050601892 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Concerta PS ORAL Risperdal SS Date:08/03/05ISR Number: 4733550-9Report Type:Direct Company Report #CTU 255320 Age:34 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Risperdal 4mg PS ORAL 4MG HS PO 7 DAY Tardive Dyskinesia Risperdal 1 Mg SS ORAL 1MG AM PO 7 DAY 22-Feb-2006 08:20 AM Page: 2615 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/04/05ISR Number: 4734802-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050705901 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Stevens-Johnson Syndrome Risperdal PS ORAL Diclofenac Sodium SS ORAL Date:08/04/05ISR Number: 4734803-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040601724 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Risperdal PS ORAL Increased Risperdal SS ORAL Haemoglobin Decreased Risperdal SS ORAL Platelet Count Increased Risperdal SS ORAL Protein Total Decreased Risperdal SS ORAL Red Blood Cell Count Risperdal SS ORAL Decreased Risperdal SS ORAL Tremor Risperdal SS ORAL Risperdal SS ORAL Risperdal SS ORAL Risperdal SS ORAL Risperdal SS ORAL Levomepromazine Maleate C ORAL Levomepromazine Maleate C ORAL Levomepromazine Maleate C ORAL Levomepromazine Maleate C ORAL Levomepromazine Maleate C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Clonazepam C ORAL Quetiapine C Quetiapine C Quetiapine C Quetiapine C Quetiapine C 22-Feb-2006 08:20 AM Page: 2616 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Quetiapine C Haloperidol C INTRAMUSCULAR Amobarbital C ORAL Bromvalerylurea C ORAL Olanzapine C ORAL Date:08/04/05ISR Number: 4734805-4Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050801096 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Deafness Risperdal Consta PS Erythromycin C Panadeine C Panadeine C Panadol C Epilim C Date:08/04/05ISR Number: 4735031-5Report Type:Expedited (15-DaCompany Report #PHBS2005JP10886 Age:91 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mucosal Erosion Voltaren PS Novartis Sector: Initial or Prolonged Oculomucocutaneous Pharma RECTAL 12.5 mg/day Syndrome Allozym SS ORAL Pyrexia Risperdal SS ORAL UNK, UNK Rash Generalised Swelling Face Date:08/05/05ISR Number: 4735756-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050705030 Age:61 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertensive Crisis Topamax PS ORAL Risperdal SS ORAL Trevilor SS ORAL Trevilor SS ORAL Ergenyl Chrono C ORAL Ergenyl Chrono C ORAL Remergil C ORAL Date:08/05/05ISR Number: 4735759-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050201087 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Risperdal PS ORAL Initial or Prolonged Hyponatraemia Ativan C Polydipsia Psychogenic Rivotril C Date:08/05/05ISR Number: 4735760-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050702671 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukocytoclastic Risperdal PS ORAL Vasculitis Rash Generalised 22-Feb-2006 08:20 AM Page: 2617 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/05/05ISR Number: 4735761-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050705646 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Risperdal Consta PS INTRAMUSCULAR Anal Cancer Lovastatin C Paxil C Date:08/05/05ISR Number: 4735762-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050105227 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperdal PS ORAL Initial or Prolonged Phosphokinase Increased Lithium Carbonate C 10 years Other Blood Pressure Carbamazepine C Fluctuation Catatonia Depression Dyspnoea Hallucination Hypomania Libido Increased Mood Altered Neuroleptic Malignant Syndrome Pulse Abnormal Respiration Abnormal Sleep Disorder White Blood Cell Count Increased Date:08/05/05ISR Number: 4735763-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050705732 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperdal PS ORAL Neurocil SS ORAL Date:08/05/05ISR Number: 4735764-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050800511 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperdal PS Insulin-Dependent Weight Increased Date:08/08/05ISR Number: 4736635-6Report Type:Expedited (15-DaCompany Report #2005UW11220 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Crestor PS Astrazeneca Hyperthermia Pharmaceuticals ORAL Loss Of Consciousness Risperdal SS Multi-Organ Failure Other Psychiatric Sepsis Medications SS 22-Feb-2006 08:20 AM Page: 2618 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/08/05ISR Number: 4738550-0Report Type:Direct Company Report #USP 57280 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Dispensing Error Risperdal M-Tab PS Janssen ORAL TABLET ORALLY Intercepted Medication DISINTEGRATIN Error G Medication Error Risperdal M-Tab SS Janssen ORAL TABLET ORALLY Wrong Drug Administered DISINTEGRATIN G Risperdal M-Tab SS Janssen ORAL TABLET ORALLY DISINTEGRATIN G Date:08/09/05ISR Number: 4738324-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050705943 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Generalised Risperdal PS ORAL Initial or Prolonged Exanthematous Pustulosis Zyloric SS ORAL Enterobacter Infection Laroxyl SS ORAL Infection Rocephine SS INTRAMUSCULAR 7 DAY Rash Maculo-Papular Neurontin SS ORAL Toxic Epidermal Elisor SS ORAL Necrolysis Lasilix C Zestril C Cordarone C Sectral C Date:08/09/05ISR Number: 4738325-2Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20050800273 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Risperdal PS UNKNOWN Death Heart Medications C UNKNOWN Hallucination Antihypertensives C UNKNOWN Date:08/09/05ISR Number: 4738326-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050800753 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:08/09/05ISR Number: 4738327-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050704140 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Risperdal PS ORAL Life-Threatening Cerebral Infarction Risperdal SS ORAL Haldol SS Levomepromazine Maleate C ORAL 5-25 mg per day Flunitrazepam C ORAL 22-Feb-2006 08:20 AM Page: 2619 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/09/05ISR Number: 4743699-2Report Type:Expedited (15-DaCompany Report #142683USA Age:37 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Foreign Pimozide PS ORAL 2 MILLIGRAM 9 DAY Electrocardiogram Qt Health Clozapine SS ORAL 25 MILLIGRAM Prolonged Professional ORAL Other Risperadone SS ORAL ORAL Haloperidol SS ORAL ORAL Desloratadine C Procyclidine C Lorazepam C Date:08/10/05ISR Number: 4740233-8Report Type:Periodic Company Report #US-GLAXOSMITHKLINE-A0548396A Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Paraesthesia Paxil PS Glaxosmithkline Risperdal SS Date:08/10/05ISR Number: 4740731-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050800751 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Administration Error Risperdal Consta PS INTRAMUSCULAR "for the past Initial or Prolonged Hospitalisation few months" Date:08/10/05ISR Number: 4740732-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050801371 Age:60 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rectal Prolapse Risperidone PS ORAL Initial or Prolonged Lithium Carbonate C ORAL Date:08/10/05ISR Number: 4740733-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050700622 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Risperdal PS ORAL 10 DAY Neuroleptic Malignant Syndrome Pyrexia Social Avoidant Behaviour Date:08/10/05ISR Number: 4740734-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050606810 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pleural Infection Risperdal PS ORAL Initial or Prolonged Risperdal SS ORAL Risperdal SS ORAL Risperdal SS ORAL Sodium Valproate C ORAL L-Cysteine Ethylester Hydrochloride C ORAL Ostazolam C ORAL 22-Feb-2006 08:20 AM Page: 2620 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pantethine C ORAL Magnesium Oxide C ORAL Quazepam C ORAL Loxoprofen C ORAL Ecabet Sodium C ORAL Date:08/10/05ISR Number: 4740735-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050600327 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Encephalopathy Risperdal PS ORAL Prostration Risperdal SS ORAL Restlessness Haloperidol SS 10 mg daily Ventricular Fibrillation Haloperidol SS Haloperidol SS INTRAMUSCULAR 30 mg daily Haloperidol SS INTRAMUSCULAR Lorazepam C ORAL Biperiden Hydrochloride C ORAL Itopride Hydrochloride C ORAL Magnesium Oxide C ORAL Mianserin Hydrochloride C ORAL Nitrazepam C ORAL Flunitrazepam C ORAL Zopiclone C ORAL Date:08/11/05ISR Number: 4742660-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050800838 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Miosis Risperdal PS ORAL Initial or Prolonged Date:08/11/05ISR Number: 4742661-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050404056 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Risperdal PS ORAL Eye Haemorrhage Temesta C Unspecified Nsai C Date:08/11/05ISR Number: 4742662-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050700877 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Endometrial Cancer Stage Risperdal PS ORAL Iii Risperdal SS ORAL Epidermal Naevus Seroquel C Metastasis Zoloft C Wound Infection 22-Feb-2006 08:20 AM Page: 2621 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/05ISR Number: 4742663-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050801305 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Risperdal PS ORAL White Blood Cell Count Fosamax C ORAL Decreased Synthroid C ORAL Arimidex C ORAL Paxil C ORAL Date:08/11/05ISR Number: 4742664-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050801767 Age:66 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchopneumopathy Risperdal PS ORAL Initial or Prolonged Cardiac Failure Noctran SS ORAL Confusional State Noctran SS ORAL Impaired Self-Care Noctran SS ORAL Rivotril SS ORAL Rivotril SS ORAL Depakine C ORAL Solupred C Seretide C Seretide C Coversyl C Date:08/11/05ISR Number: 4742666-2Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20050705929 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertensive Crisis Risperdal Consta PS INTRAMUSCULAR Risperdal SS ORAL Risperdal SS ORAL Lithium Carbonate C ORAL Quetiapine C ORAL Date:08/11/05ISR Number: 4742880-6Report Type:Expedited (15-DaCompany Report #PHBS2005KR11463 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Thioridazine PS Novartis Sector: Initial or Prolonged Mania Pharma 100 mg/d Pancytopenia Valproic Acid SS ORAL 2 g/d Valproic Acid SS ORAL 1.5 g/d Valproic Acid SS ORAL 1.5 g/d Risperidone SS 2 mg/d Risperidone SS 8 mg/d Amisulpride C 400 mg, BID Zolpidem C 10 mg, QHS Benztropine Mesylate C 1 mg, QD Date:08/11/05ISR Number: 4744245-XReport Type:Direct Company Report #CTU 255984 Age:6 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 2622 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Accidental Overdose Risperdal 1mg/Ml Apnoea Janssen PS Janssen ORAL 0.5 MG BID Convulsion ORAL Hyponatraemia Adderall C Hypotension Incorrect Dose Administered Medication Error Pharmaceutical Product Complaint Date:08/12/05ISR Number: 4744098-XReport Type:Expedited (15-DaCompany Report #TR-JNJFOC-20050705927 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertensive Crisis Risperdal Consta PS INTRAMUSCULAR Date:08/12/05ISR Number: 4744099-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050800840 Age:92 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL 3 WK Date:08/12/05ISR Number: 4744100-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050801170 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Risperdal PS ORAL taken for a Initial or Prolonged Partial Seizures With long period Other Secondary Generalisation of time. Status Epilepticus Melperon C reported as a small dose Orifil C dose increase Orifil C Date:08/12/05ISR Number: 4744101-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050801494 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Risperdal PS ORAL Initial or Prolonged Fall Risperdal SS ORAL General Physical Health Risperdal SS ORAL Deterioration Stangyl C ORAL Mental Impairment Date:08/12/05ISR Number: 4744102-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050601182 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Movement Disorder Risperdal PS ORAL Joint Stiffness Risperdal SS ORAL Sensory Disturbance 22-Feb-2006 08:20 AM Page: 2623 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/05ISR Number: 4744103-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050801813 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Risperdal PS ORAL Increased Clozapine SS Aspartate Aminotransferase Increased Platelet Count Decreased Date:08/15/05ISR Number: 4744693-8Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12899621 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Creatine Abilify Tabs 15 Mg PS Otsuka Other Phosphokinase Increased Pharmaceutical Cardiac Arrest Company, Ltd. ORAL Electrocardiogram St Lepticur SS Segment Elevation Rivotril SS Fall Tercian SS ORAL Hyperkalaemia Lipanthyl SS ORAL Malaise Risperdal SS Psychomotor Hyperactivity Respiratory Arrest Date:08/15/05ISR Number: 4745088-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050702814 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal Consta PS INTRAMUSCULAR Breast Cancer Lustral C ORAL Breast Discharge Lustral C ORAL Date:08/15/05ISR Number: 4745387-5Report Type:Periodic Company Report #20041000447 Age:8 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Drug Reaction Literature Chlorpromazine Ampul PS Death Health Haloperidol SS Professional Risperidone SS Date:08/15/05ISR Number: 4745772-1Report Type:Direct Company Report #CTU 256172 Age:78 YR Gender:Male I/FU:I Outcome PT Hospitalization - Autonomic Nervous System Initial or Prolonged Imbalance Bacteria Urine Identified Blood Creatine Phosphokinase Increased Blood Pressure Increased Fall Leukocytosis Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia 22-Feb-2006 08:20 AM Page: 2624 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Serotonin Syndrome Tremor Report Source Product Role Manufacturer Route Dose Duration Risperidone 1 Mg Jannsen PS Jannsen ORAL 1 QAM, 0.5 Q 4 PM, 1.5 QHS ORAL Sertraline 100 Mg Pfizer SS Pfizer ORAL 150 MG QD ORAL Date:08/15/05ISR Number: 4746515-8Report Type:Expedited (15-DaCompany Report #2005111246 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Generalised Foreign Neurontin Initial or Prolonged Exanthematous Pustulosis Health (Gabapentin) PS ORAL 300 MG, ORAL Dermatitis Professional Amitriptyline Prurigo Hydrochloride Toxic Epidermal (Amitriptyline Necrolysis Hydrochloride) SS ORAL 50 MG, ORAL Allopurinol (Allopurinol) SS ORAL 200 MG, ORAL Rocephine (Ceftriaxone) SS INTRAMUSCULAR 2 GRAM (1 IN1 D), INTRAMUSCULAR Risperdal (Risperidone) SS ORAL 2 MG (2 MG, 1 IN 1 D), ORAL Elisoe (Pravastatin Sodium) SS ORAL 20 MG (20 MG, 1 IN 1 D), ORAL Lasilix (Furosemide) C Zestril (Lisinopril) C Cordarone (Amiodarone Hydrochloride) C Sectral (Acebutolol Hydrochloride) C Date:08/15/05ISR Number: 4746637-1Report Type:Expedited (15-DaCompany Report #S05-CAN-02841-01 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradyphrenia Foreign Celexa (Citalopram Dissociation Health Hydrobromide) PS 10 MG QD Fatigue Professional Risperidone SS 10 MG QD Insomnia Other Reflexes Abnormal Stupor Tinnitus Visual Disturbance 22-Feb-2006 08:20 AM Page: 2625 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/15/05ISR Number: 4747098-9Report Type:Expedited (15-DaCompany Report #S05-USA-03846-01 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Health Lexapro Initial or Prolonged Condition Aggravated Professional (Escitalopram) PS ORAL 10 MG QD PO Depression Lexapro Mental Disorder (Escitalopram) SS ORAL 20 MG QD PO Paranoia Lexapro Psychotic Disorder (Escitalopram) SS ORAL 30 MG QD PO Somnolence Wellbutrin (Bupropion Hydrochloride) SS Risperdal (Risperidone) SS ORAL 3 MG QD PO Risperdal (Risperidone) SS Risperdal (Risperidone) SS ORAL 0.5 MG QD PO Multivitamin C Date:08/16/05ISR Number: 4745872-6Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-13064902 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Generalised Elisor Tabs PS Bristol-Myers Squibb Initial or Prolonged Exanthematous Pustulosis Company ORAL Enterobacter Infection Zyloric SS Rash Maculo-Papular Rocephine SS INTRAMUSCULAR Laroxyl SS Neurontin SS Risperdal SS Lasilix C Zestril C Cordarone C Sectral C Date:08/16/05ISR Number: 4746054-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050802971 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal PS ORAL Decreased Date:08/16/05ISR Number: 4746055-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050507448 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancytopenia Risperdal PS ORAL Initial or Prolonged Sennoside C ORAL Other Ferrous Sulfate C ORAL Date:08/16/05ISR Number: 4746451-7Report Type:Direct Company Report #CTU 256238 Age: Gender:Male I/FU:I Outcome PT Other Anxiety Cogwheel Rigidity 22-Feb-2006 08:20 AM Page: 2626 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dyskinesia Gait Disturbance Musculoskeletal Stiffness Report Source Product Role Manufacturer Route Dose Duration Tremor Risperidone PS ORAL 2 MG PO QHS Omeprazole C Felodipine C Atenolol C Casodex C Goserelin C Simvastatin C Lorazepam C Date:08/17/05ISR Number: 4746660-7Report Type:Expedited (15-DaCompany Report #PHRM2005FR02237 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alpha 2 Globulin Nitriderm Tts PS Novartis Sector: Initial or Prolonged Increased Pharma TRANSDERMAL 10 mg/day Electrophoresis Protein Pipram SS ORAL 400 mg, BID 7200 MIN Abnormal Ditropan SS ORAL 2.5 mg, BID Hypoalbuminaemia Sectral SS ORAL 100 mg, BID Leukocytoclastic Zoloft SS ORAL 50 mg/day Vasculitis Risperdal SS ORAL 0.5 mg/day Purpura Spasfon-Lyoc SS ORAL Temesta SS ORAL 1.5 mg/day Dafalgan SS ORAL 3 g/day Fragmin SS SUBCUTANEOUS 2500 IU/day Date:08/17/05ISR Number: 4746968-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050201372 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Pregnancy Risperdal Consta SS INTRAMUSCULAR Schizophrenia Depakote C ORAL Date:08/17/05ISR Number: 4746969-7Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050701159 Age:94 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Myocardial Risperdal PS ORAL (0.5 mg in Hospitalization - Infarction the morning Initial or Prolonged and 1.5 mg at Other night) Risperdal SS ORAL Diuretic C UNKNOWN Avanza C UNKNOWN Date:08/17/05ISR Number: 4746970-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050704036 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Retinal Vein Occlusion Risperdal PS ORAL 22-Feb-2006 08:20 AM Page: 2627 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/18/05ISR Number: 4748195-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050703088 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Risperdal PS ORAL Initial or Prolonged Liver Function Test Risperdal SS ORAL Abnormal Risperdal SS ORAL Otitis Media Risperdal SS ORAL Pancytopenia Adderall Xr C ORAL Pyrexia Adderall Xr C ORAL Sedation Adderall Xr C ORAL Splenomegaly Adderall Xr C ORAL (30 mg in AM, 10 mg in PM) Clonidine C Date:08/18/05ISR Number: 4748196-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050701389 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Risperdal PS ORAL Initial or Prolonged Insulin-Dependent Adderall C Adderall C Adderall C Adderall C Date:08/18/05ISR Number: 4748197-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050802485 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Ischaemia Risperdal PS ORAL Initial or Prolonged Hemiparesis Risperdal SS ORAL Other Date:08/18/05ISR Number: 4748198-XReport Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050703864 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Risperdal PS Date:08/19/05ISR Number: 4749041-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050502966 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Drug Exposure During Risperdal PS Other Pregnancy Risperdal SS Patent Ductus Arteriosus Pneumothorax Date:08/22/05ISR Number: 4749677-1Report Type:Expedited (15-DaCompany Report #PHNU2005DE02527 Age:46 YR Gender:Male I/FU:F Outcome PT Life-Threatening Hodgkin'S Disease Hospitalization - Laryngospasm Initial or Prolonged Leukopenia Other Lymphadenopathy Neutropenia 22-Feb-2006 08:20 AM Page: 2628 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neutrophilia Oculogyration Pyrexia Report Source Product Role Manufacturer Route Dose Duration Surgery Leponex / Clozaril (Clozapine) PS Novartis Sector: Pharma ORAL up to 600 mg, QD Olanzapine SS ORAL 30 mg/day Risperdal SS ORAL 3 mg, QD 98 DAY Aripiprazole SS ORAL 10 mg/day Tavor C UNKNOWN 1.5 mg - 3 mg/day Agopton C ORAL 30 mg, QD 100 DAY Gastrozepin C ORAL 50 mg, QD 28800MIN Date:08/22/05ISR Number: 4749790-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050803318 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Risperdal PS ORAL Initial or Prolonged Dyspnoea Antipsychotics C Fluid Retention Benadryl C Gastrooesophageal Reflux Disease Weight Decreased Date:08/22/05ISR Number: 4749791-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050803659 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Risperdal PS ORAL Initial or Prolonged Endometrial Hyperplasia Other Date:08/22/05ISR Number: 4749792-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050606006 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Risperdal Consta PS INTRAMUSCULAR 6 MON Drug Exposure During Risperdal SS ORAL Pregnancy Date:08/22/05ISR Number: 4750869-6Report Type:Expedited (15-DaCompany Report #2004106748 Age:29 YR Gender:Not SpecifiI/FU:F Outcome PT Hospitalization - Abnormal Behaviour Initial or Prolonged Aggression Other Agitation Delusion Depression Drug Ineffective Hallucination, Auditory Hallucination, Visual Homicidal Ideation Intentional Misuse Lethargy 22-Feb-2006 08:20 AM Page: 2629 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Overdose Psychotic Disorder Refusal Of Treatment By Report Source Product Role Manufacturer Route Dose Duration Patient Consumer Neurontin (Tablets) Somnolence (Gabapentin) PS 900 MG (300 Stress MG, 3 IN 1 D) Suicide Attempt Neurontin Treatment Noncompliance (Gabapentin) SS 900 MG (300 MG, 3 IN 1 D) Haldol (Haloperidol) SS Risperidone (Risperidone) SS 6 MG (3 MG, 2 IN 1 D) Seroquel (Quetiapine Fumarate) C Metformin (Metformin) C Date:08/22/05ISR Number: 4751340-8Report Type:Expedited (15-DaCompany Report #2005115821 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Health Geodon (Ziprasidone) PS 180 MG (1 D) Initial or Prolonged Prolonged Professional Risperdal Other Palpitations Company (Risperidone) SS Representative Date:08/22/05ISR Number: 4751366-4Report Type:Expedited (15-DaCompany Report #HQWYE903015AUG05 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Effexor Xr Conversion Disorder Professional (Venlafaxine Convulsion Company Hydrochloride, Fatigue Representative Capsule, Extended Staring Release) PS ORAL 37.5 MG 1X PER 1 DAY ORAL Risperdal (Risperidone) SS Date:08/22/05ISR Number: 4751700-5Report Type:Expedited (15-DaCompany Report #DSA_26586_2005 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depressive Symptom Foreign Lorazepam PS ORAL 2 MG Q DAY PO Initial or Prolonged Hypertension Health Risperidone SS ORAL DF Q DAY PO Insomnia Professional Zolpidem SS ORAL 10 MG Q DAY Oral Candidiasis Other PO Suicidal Ideation Urinary Tract Infection 22-Feb-2006 08:20 AM Page: 2630 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/05ISR Number: 4750319-XReport Type:Expedited (15-DaCompany Report #KR-JNJFOC-20050804525 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gamma-Glutamyltransferase Reminyl PS ORAL 49 DAY Increased Risperdal SS 49 DAY Jaundice Tanamin C ORAL Stilnox C ORAL Chlorpromazine Hcl C ORAL Date:08/23/05ISR Number: 4750320-6Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20050803345 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorexia Risperdal PS ORAL Initial or Prolonged Bone Pain Torem C ORAL Confusional State Digoxin C ORAL Disorientation Enatec C ORAL Extrapyramidal Disorder Rocaltrol C ORAL Fall Detrusitol C ORAL Fatigue Neo-Mercazole C ORAL Mental Disorder Dafalgan C ORAL Myalgia Imovane C ORAL Psychomotor Hyperactivity Urinary Tract Infection Date:08/23/05ISR Number: 4750321-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050803695 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal Consta PS INTRAMUSCULAR Date:08/23/05ISR Number: 4750322-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050203426 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Haemorrhage Risperdal PS ORAL Convulsion Risperdal SS ORAL Depressed Level Of Sodium Valproate C Consciousness Zonisamide C Fall Sennoside C Haemolytic Anaemia Clobazam C Phenytoin C Date:08/23/05ISR Number: 4750466-2Report Type:Expedited (15-DaCompany Report #S05-USA-03846-01 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Wellbutrin PS Glaxosmithkline ORAL Initial or Prolonged Depression Lexapro SS ORAL 10MG Per day MON Fatigue Risperdal SS ORAL 3MG Per day 8 MON Mental Disorder Multivitamin C ORAL Paranoia Psychotic Disorder Somnolence 22-Feb-2006 08:20 AM Page: 2631 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/05ISR Number: 4750507-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050802971 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Risperdal PS ORAL Initial or Prolonged Cellulitis Risperdal SS ORAL Other Platelet Count Decreased Flunitrazepam SS ORAL Vomiting Flunitrazepam SS ORAL White Blood Cell Count Risperdal SS ORAL Decreased Alprazolam C ORAL Alprazolam C ORAL Alprazolam C ORAL Diazepam C Unspecified C ORAL Date:08/23/05ISR Number: 4751212-9Report Type:Direct Company Report #CTU 256812 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Risperdal PS INJECTION Hospitalization - Pneumonia EVERY 3 WKS Initial or Prolonged Date:08/23/05ISR Number: 4752914-0Report Type:Periodic Company Report #US-JNJFOC-20050602350 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR 25 MG, Representative INTRA-MUSCULA R Date:08/23/05ISR Number: 4752915-2Report Type:Periodic Company Report #US-JNJFOC-20050505752 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Risperdal Consta Decreased Professional (Risperidone) Company Microspheres PS 25 MG Representative Depakote (Valproate Semisodium) C Date:08/23/05ISR Number: 4752916-4Report Type:Periodic Company Report #US-JNJFOC-20050504673 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Cholesterol Health Risperdal Consta Increased Professional (Risperidone) Diabetes Mellitus Company Microspheres PS INTRAMUSCULAR 1 IN 2 WEEK, Weight Increased Representative INTRA-MUSCULA R 22-Feb-2006 08:20 AM Page: 2632 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/05ISR Number: 4752917-6Report Type:Periodic Company Report #US-JNJFOC-20050204543 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Consumer Risperdal Consta Initial or Prolonged Akathisia Health (Risperidone) Other Tachycardia Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Tablets SS ORAL SEE IMAGE Date:08/23/05ISR Number: 4752918-8Report Type:Periodic Company Report #US-JNJFOC-20050302736 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Influenza Like Illness Health Risperdal Consta Leukopenia Professional (Risperidone) Rash Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Cogentin (Benzatropine Mesilate) C Date:08/23/05ISR Number: 4752919-XReport Type:Periodic Company Report #US-JNJFOC-20050800322 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Health Risperdal Consta Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Topamax (Topiramate) C Seroquel (Quetiapine Fumarate) C Lexapro (All Other Therapeutic Products) Tablets C Date:08/23/05ISR Number: 4752920-6Report Type:Periodic Company Report #US-JNJFOC-20050705124 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Schizophrenia Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR 50 MG, Representative INTRA-MUSCULA R Clozaril (Clozapine) C 22-Feb-2006 08:20 AM Page: 2633 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/05ISR Number: 4752921-8Report Type:Periodic Company Report #US-JNJFOC-20050704945 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Consumer Risperdal Consta Initial or Prolonged Insomnia Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 37.5 MG, IN 2 WEEK, INTRA-MUSCULA R Depakote (Valproate Semisodium) Tablets C Trazadone (Trazodone) Tablets C Cogentin (Benzatropine Mesilate) Tablets C Risperdal (Risperidone) Tablets C Date:08/23/05ISR Number: 4752922-XReport Type:Periodic Company Report #US-JNJFOC-20050702277 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Consta Initial or Prolonged Syndrome Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Representative WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Tablets SS ORAL 2 MG, IN 1 DAY, ORAL Date:08/23/05ISR Number: 4752923-1Report Type:Periodic Company Report #US-JNJFOC-20050700874 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Increased Health Risperdal Consta Injection Site Professional (Risperidone) Haemorrhage Company Microspheres PS INTRAMUSCULAR 37.5 MG, 1 IN Thrombocytopenia Representative 2 WEEK, INTRA-MUSCULA R; 25 MG, 1 IN 2 WEEK, Zoloft (Sertraline Hydrochloride) C Date:08/23/05ISR Number: 4752924-3Report Type:Periodic Company Report #US-JNJFOC-20050701324 Age:41 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Tachycardia Consumer Risperdal Consta Initial or Prolonged Tardive Dyskinesia (Risperidone) Microspheres PS INTRAMUSCULAR 50 MG, INTRA-MUSCULA R 22-Feb-2006 08:20 AM Page: 2634 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/23/05ISR Number: 4752925-5Report Type:Periodic Company Report #US-JNJFOC-20050701668 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebrovascular Accident Health Risperdal Consta Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR 37.5 MG, Representative INTRA-MUSCULA R Date:08/23/05ISR Number: 4752926-7Report Type:Periodic Company Report #US-JNJFOC-20050700179 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Consumer Risperdal Consta Increased Appetite (Risperidone) Insomnia Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Judgement Impaired WEEK, Mania INTRA-MUSCULA Weight Increased R Paxil (Paroxetine Hydrochloride) C Depakote (Valproate Semisodium) C Risperidone (Risperidone) Tablets C Date:08/23/05ISR Number: 4752927-9Report Type:Periodic Company Report #US-JNJFOC-20050606581 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Consta Initial or Prolonged Syndrome Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR INTRA-MUSCULA Representative R Risperdal (Risperidone) Talbets SS ORAL ORAL Date:08/23/05ISR Number: 4752928-0Report Type:Periodic Company Report #US-JNJFOC-20050606668 Age:19 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Health Risperdal Consta Initial or Prolonged Syndrome Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR 1 IN 2 WEEK, Representative INTRA-MUSCULA R Risperdal (Risperidone) Tablets SS ORAL ORAL Haldol (Haloperidol) C Geodon (Ziprasidone Hydrochloride) C 22-Feb-2006 08:20 AM Page: 2635 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/24/05ISR Number: 4751239-7Report Type:Direct Company Report #CTU 256835 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Medication Error Risperdal M-Tab 1 Mg Janssen PS Janssen Risperdal M-Tab 2 Mg Janssen SS Janssen Date:08/24/05ISR Number: 4751625-5Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050404025 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Risperdal Consta PS INTRAMUSCULAR Drug Exposure During Aripriprazol SS ORAL Pregnancy Aripriprazol SS ORAL Quetiapine C ORAL Chlorpramazine C ORAL Diazepam C ORAL Benzhexol C ORAL Multivitamin C ORAL Multivitamin C ORAL Multivitamin C ORAL Multivitamin C ORAL Multivitamin C ORAL Multivitamin C ORAL Multivitamin C ORAL Multivitamin C ORAL Folic Acid C ORAL Date:08/24/05ISR Number: 4751626-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050805237 Age:39 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Risperdal Consta PS INTRAMUSCULAR 130 DAY Initial or Prolonged Thrombocytopenic Purpura Date:08/24/05ISR Number: 4751636-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050700013 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Phosphokinase Increased Athymil C Other Catatonia Temesta C Extrapyramidal Disorder Stilnox C dose = tablet Hyperhidrosis Hypertension Pyrexia Sinus Tachycardia Date:08/24/05ISR Number: 4752109-0Report Type:Direct Company Report #CTU 256875 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Proinsulin Risperidone 4mg Increased Janssen PS Janssen ORAL 4-6MG DAILY Glycosylated Haemoglobin PO Increased Sertraline C 22-Feb-2006 08:20 AM Page: 2636 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Trazodone C Buspirone C Levothyroxine C Date:08/24/05ISR Number: 4752126-0Report Type:Direct Company Report #CTU 256876 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Increased Risperidone 4mg Glycosylated Haemoglobin Janssen PS Janssen ORAL 2-6MG DAILY Increased PO Prednisone C Ziprasidone C Pantoprazole C Metoprolol C Divalproex Sodium C Escitalopram C Date:08/25/05ISR Number: 4752163-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050803761 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Risperdal PS ORAL Cardiomyopathy Carbamazepine C ORAL Tachycardia Paroxetine C ORAL Diazepam C ORAL Date:08/25/05ISR Number: 4752164-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050700386 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Risperdal PS ORAL Initial or Prolonged Neutropenia Risperdal SS ORAL Other Weight Decreased Prozac C Prozac C Date:08/25/05ISR Number: 4752165-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050600327 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Encephalopathy Risperdal PS ORAL Prostration Risperdal SS ORAL Restlessness Haloperidol SS 10 mg daily Ventricular Fibrillation Haloperidol SS Haloperidol SS INTRAMUSCULAR 30 mg daily Haloperidol SS INTRAMUSCULAR Lorazepam C ORAL Biperiden Hydrochloride C ORAL Itopride Hydrochloride C ORAL Magnesium Oxide C ORAL Mianserin Hydrochloride C ORAL Nitrazepam C ORAL Flunitrazepam C ORAL Zopiclone C ORAL 22-Feb-2006 08:20 AM Page: 2637 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/25/05ISR Number: 4752166-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050705732 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperdal PS ORAL Risperdal SS ORAL Risperdal SS ORAL Neurocil SS ORAL Risperdal SS ORAL Date:08/25/05ISR Number: 4752167-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050804661 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperdal PS Date:08/25/05ISR Number: 4752168-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050804755 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coagulation Factor Risperdal PS ORAL Decreased Risperdal SS ORAL Contusion Platelet Function Test Abnormal Date:08/25/05ISR Number: 4752169-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050803659 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Risperdal PS ORAL Initial or Prolonged Endometrial Hyperplasia Other Date:08/25/05ISR Number: 4754335-3Report Type:Direct Company Report #CTU 256927 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Diabetes Mellitus Abilify 15 Mg Intervention to Bristol Myer Prevent Permanent Squibb PS Bristol Myer Squibb ORAL 15 MG 2 Impairment/Damage TABS QAM PO Risperdal 1 Mg Janssen SS Janssen ORAL 1 MG 1 TAB BID PO Date:08/25/05ISR Number: 4754357-2Report Type:Expedited (15-DaCompany Report #B0390847A Age:35 YR Gender:Female I/FU:I Outcome PT Hospitalization - Cerebellar Syndrome Initial or Prolonged Cerebral Disorder Coma Diarrhoea Dysarthria Extensor Plantar Response Haemodialysis 22-Feb-2006 08:20 AM Page: 2638 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemodynamic Instability Multi-Organ Disorder Neuroleptic Malignant Report Source Product Role Manufacturer Route Dose Duration Syndrome Foreign Lithium Carbonate Nosocomial Infection Literature (Lithium Carbonate) Overdose Health (Formulation Renal Failure Acute Professional Unknown) (Generic) PS SEE DOSAGE Somnolence TEXT Therapeutic Agent Risperidone Toxicity (Formulation Vomiting Unknown) (Risperidone) SS 2 DAY Date:08/25/05ISR Number: 4754986-6Report Type:Expedited (15-DaCompany Report #S05-FRA-03006-01 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Seropram (Citalopram Drug Abuser Health Hydrobromide) PS ORAL 20 MG QD PO Professional Risperdal Other (Risperidone) SS INTRAMUSCULAR 50 MG IM Lepticur (Tropatepine Hydrochloride) C Stilnox (Zolpidem) C Rivotril (Clonazepam) C Date:08/26/05ISR Number: 4753227-3Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0308604-00 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anxiety Depakote PS ORAL Confusional State Depakote SS ORAL Disorientation Valpromide SS ORAL 2 YR Drug Level Decreased Penfluridol SS ORAL Drug Level Increased Risperidone SS UNKNOWN Encephalopathy Amlodipine Besilate C ORAL Extrapyramidal Disorder Amlodipine Besilate C Lethargy Alprazolam C ORAL Alprazolam C ORAL Trihexyphenidyl Hydrochloride C ORAL Zolpidem C ORAL Bisoprolol C ORAL Date:08/26/05ISR Number: 4753573-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050701927 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Diarrhoea Zoloft C Dyspnoea Exacerbated Cortancyl C General Physical Diffu K C dose= tablet Condition Mopral C Sinus Tachycardia 22-Feb-2006 08:20 AM Page: 2639 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/05ISR Number: 4753574-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050804314 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Risperdal PS Dose reported Initial or Prolonged Drug Withdrawal Syndrome as 1-5mg Hallucination daily prn Somnolence Risperdal SS Restarted on an unknown date Dose reported as 1-5mg daily Epilim SS dose reported as 500mg Epilim EC tds and 100mg eplim Methadone C Olanzapine C Paroxetine C Date:08/26/05ISR Number: 4753575-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050704266 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Risperdal Consta PS INTRAMUSCULAR Prolonged Depakote C Methotrimeprazine C taken as required Date:08/26/05ISR Number: 4753576-9Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20050805280 Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Precocious Puberty Risperdal PS Risperdal SS Date:08/26/05ISR Number: 4753577-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050802971 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Risperdal PS ORAL Initial or Prolonged Cellulitis Risperdal SS ORAL Other Platelet Count Decreased Flunitrazepam SS ORAL Vomiting Flunitrazepam SS ORAL White Blood Cell Count Risperdal SS ORAL Decreased Alprazolam C ORAL Alprazolam C ORAL Alprazolam C ORAL Diazepam C Unspecified C ORAL Date:08/26/05ISR Number: 4763069-0Report Type:Periodic Company Report #USA-2004-0017596 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Death Accidental Overdose Consumer Multiple Drug Overdose Health 22-Feb-2006 08:20 AM Page: 2640 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Other Product Role Manufacturer Route Dose Duration Oxycodone Hydrochloride (Similar To Nda 20-553) Oxycodone Hydrochloride) PS Fluoxetine (Fluoxetine) SS Risperidone (Risperidone) SS Metoprolol (Metoprolol) SS Mirtazapine (Mirtazapine) SS Date:08/29/05ISR Number: 4754238-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050505752 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal Consta PS White Blood Cell Count Depakote C Decreased Date:08/29/05ISR Number: 4754239-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050604252 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ascites Risperdal PS ORAL Hepatic Cirrhosis Leukopenia Platelet Count Decreased Date:08/29/05ISR Number: 4754240-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050804575 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypersensitivity Risperdal Quicklet PS ORAL Initial or Prolonged Swelling Face Risperdal Quicklet SS ORAL Urticaria Risperdal Consta SS INTRAMUSCULAR Thyronajod C Thyronajod C Date:08/30/05ISR Number: 4755649-3Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13003140 Age:30 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Abilify Tabs 30 Mg PS Otsuka Initial or Prolonged Somnolence Pharmaceutical Suicide Attempt Company, Ltd. ORAL 24 HR Levothyroxine SS Risperdal SS Lithium SS Sertraline SS 22-Feb-2006 08:20 AM Page: 2641 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/30/05ISR Number: 4756834-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050804935 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Risperdal PS UNKNOWN Date:08/30/05ISR Number: 4756835-9Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050805496 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS Date:08/30/05ISR Number: 4756836-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041106871 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Risperdal PS ORAL Haemoglobin Decreased Risperdal SS ORAL Hyperglycaemia Risperdal SS ORAL Red Blood Cell Count Oren-Gedoku-To C ORAL Decreased Oren-Gedoku-To C ORAL White Blood Cell Count Oren-Gedoku-To C ORAL Decreased Estazolam C ORAL Flurazepam Hydrochloride C ORAL Promethazine Hydrochloride C ORAL Trihexyphenidyl Hydrochloride C ORAL Ecabet Sodium C ORAL Rilmazafone Hydrochloride C ORAL Date:08/30/05ISR Number: 4757841-0Report Type:Expedited (15-DaCompany Report #2005-131810-NL Age:15 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Galactorrhoea Foreign Mirtazapine PS 15 MG/30 MG 207 DAY Initial or Prolonged Sinus Tachycardia Risperidone SS 4 WK Weight Increased Quetiapine Fumarate SS MG 81 DAY Olanzapine C Aripiprazole C Date:08/30/05ISR Number: 4758527-9Report Type:Direct Company Report #CTU 257201 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dystonia Risperidone PS ORAL 1 MG , BID , Muscle Spasms PO Date:08/31/05ISR Number: 4757356-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050702517 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Inflammatory Bowel Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Disease Parkinane C 22-Feb-2006 08:20 AM Page: 2642 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/31/05ISR Number: 4757357-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050700622 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperhidrosis Risperdal PS ORAL 10 DAY Neuroleptic Malignant Syndrome Pyrexia Social Avoidant Behaviour Date:08/31/05ISR Number: 4757358-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050804902 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Risperdal PS ORAL 0.5 tablet Initial or Prolonged Haematoma daily (strength unknown). Nidrel C UNKNOWN Tegretol C UNKNOWN Triatec C UNKNOWN Minisintrom C UNKNOWN Minisintrom C UNKNOWN Date:08/31/05ISR Number: 4757596-XReport Type:Expedited (15-DaCompany Report #2005SE04772 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Seroquel PS Zeneca Initial or Prolonged Blood Prolactin Increased Pharmaceutical ORAL 300+400 MG Galactorrhoea DAILY 81 DAY Headache Remeron SS ORAL 207 DAY Nausea Risperdal SS ORAL 0.5-1 MG Orthostatic Hypotension TWICE DAILY 28 DAY Sinus Tachycardia Zyprexa SS ORAL 15-20 MG IN Syncope THE EVENING Weight Increased Date:08/31/05ISR Number: 4757599-5Report Type:Expedited (15-DaCompany Report #2005PK01130 Age:8028 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Seroquel PS Zeneca Pharmaceutical ORAL 100 MG TO 800 MG 29 DAY Risperdal SS ORAL 2 MG TO 4 MG 10 DAY Solian SS ORAL 100 MG TO 400 MG 44 DAY Abilify SS ORAL Date:08/31/05ISR Number: 4759145-9Report Type:Expedited (15-DaCompany Report #S05-FRA-03152-01 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertriglyceridaemia Foreign Seroplex Initial or Prolonged Microlithiasis Health (Escitalopram) PS ORAL 10 MG QD PO Pancreatitis Acute Professional Risperdal Other (Risperidone) SS 22-Feb-2006 08:20 AM Page: 2643 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal (Risperidone) SS Lexomil (Bromazepam) SS Lexomil (Bromazepam) SS Tranxene (Clorazepate Dipotassium) SS Tranxene (Clorazepate Dipotassium) SS Stilnox (Zolpidem) SS Stilnox (Zolpidem) SS Atarax (Hydroxyzine Hydrochloride) SS Atarax (Hydroxyzine Hydrochloride) SS Athymil (Mianserin Hydrochloride) SS Athymil (Mianserin Hydrochloride) SS Insulin C Date:08/31/05ISR Number: 4759160-5Report Type:Expedited (15-DaCompany Report #S05-CAN-03153-01 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Foreign Citalopram PS Depression Health Neurontin Drug Interaction Professional (Gabapentin) SS 1800 MG DAILY Pathological Fracture Other Risperdal Psychotic Disorder (Risperidone) SS Seroquel (Quetiapine Fumarate) SS Loxapine C Date:08/31/05ISR Number: 4759507-XReport Type:Expedited (15-DaCompany Report #2005119103 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anticonvulsant Drug Level Consumer Dilantin Suspension Decreased Health (Phenytoin Sodiuim) PS ORAL 400 MG (200 Grand Mal Convulsion Professional MG, 2 IN 1 D), ORAL Risperdal (Risperidone) SS INTRAMUSCULAR 50 MG (50 MG, 1 IN 2WK), INTRAMUSCULAR Risperdal (Risperidone) SS ORAL 6 MG (6 MG, 1 IN 1D),ORAL Synthroid (Levothyroxine Sodium) C Prilosec (Omeprazole) C Ativan (Lorazepam) C Reglan (Metoclopramide) C Colace (Docusate 22-Feb-2006 08:20 AM Page: 2644 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium) C Loratadine (Loratadine) C Ranitidine (Ranitidine Hydrochloride) C Ibuprofen (Ibuprofen) C Date:08/31/05ISR Number: 4760330-0Report Type:Expedited (15-DaCompany Report #2005-BP-14294RO Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Foreign Lithium Carbonate Dyskinesia Literature (Lithium Carbonate) PS ORAL 800 MG DAILY, Extrapyramidal Disorder Health PO Professional Risperidone (Risperidone) SS 2 TO 5 MG Date:09/01/05ISR Number: 4758592-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050506155 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Carpal Tunnel Syndrome Risperdal PS Initial or Prolonged Dystonia Paxil Cr SS (at night) Fall Lorazepam C (in 3 divided Muscle Necrosis doses) Muscle Spasms Ultram C Neck Injury Hydrocodone #5 C Nerve Injury Date:09/01/05ISR Number: 4758593-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050805821 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Emotional Distress Risperdal PS ORAL Rhabdomyolysis Date:09/01/05ISR Number: 4758594-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050702814 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal Consta PS INTRAMUSCULAR Breast Cancer Lustral C ORAL Breast Discharge Lustral C ORAL Epilim Chrono C Zimovane C taken prn Date:09/01/05ISR Number: 4758595-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050802971 Age:83 YR Gender:Female I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Cellulitis Other Leukopenia Platelet Count Decreased Thrombocytopenia 22-Feb-2006 08:20 AM Page: 2645 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vomiting White Blood Cell Count Decreased Report Source Product Role Manufacturer Route Dose Duration Risperdal PS ORAL Risperdal SS ORAL Flunitrazepam SS ORAL Flunitrazepam SS ORAL Risperdal SS ORAL Alprazolam C ORAL Alprazolam C ORAL Alprazolam C ORAL Diazepam C Powdered Rhubarb C ORAL Date:09/01/05ISR Number: 4758596-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050704140 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Atrial Fibrillation Risperdal PS ORAL Life-Threatening Cerebral Artery Occlusion Risperdal SS ORAL Cerebral Infarction Risperdal SS ORAL Haldol SS "2 dosage form per day" Risperdal SS ORAL Risperdal SS ORAL Levomepromazine Maleate C ORAL Levomepromazine Maleate C ORAL Levomepromazine Maleate C ORAL Levomepromazine Maleate C INTRAMUSCULAR Flunitrazepam C ORAL Date:09/01/05ISR Number: 4759401-4Report Type:Expedited (15-DaCompany Report #CH-ABBOTT-05P-151-0309502-00 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Biperiden Initial or Prolonged Chills Hydrochloride PS Extrapyramidal Disorder Glibornuride SS ORAL Fatigue Risperidone SS ORAL General Physical Health Furosemide SS ORAL Deterioration Hyzaar SS ORAL Hypotension Valproate Sodium C Neuroleptic Malignant Valproate Sodium C Syndrome Lorazepam C Pyrexia Acetylsalicylic Acid C Tachycardia Metformin Urinary Incontinence Hydrochloride C Date:09/01/05ISR Number: 4760945-XReport Type:Expedited (15-DaCompany Report #S05-USA-04089-01 Age:84 YR Gender:Female I/FU:I Outcome PT Other Alanine Aminotransferase Increased 22-Feb-2006 08:20 AM Page: 2646 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aspartate Aminotransferase Increased Report Source Product Role Manufacturer Route Dose Duration Bilirubin Conjugated Health Namenda (Memantine) PS ORAL 10 MG BID PO Increased Professional Celebrex (Celecoxib) SS ORAL 200 MG PO Blood Alkaline Company Risperdal Phosphatase Increased Representative (Risperidone) SS 0.25 MG QD Mulitple Medications (Nos) C Date:09/01/05ISR Number: 4761137-0Report Type:Expedited (15-DaCompany Report #2005-129153-NL Age:80 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebrovascular Accident Foreign Mirtazapine PS ORAL 15 MG, ORAL Initial or Prolonged Headache Risperidone SS ORAL 2 MG/1 MG, Hyperprolactinaemia ORAL Hypertension Di-Antalvic SS ORAL 1 DF, ORAL Necrosis Metformin Nuclear Magnetic Hydrochloride SS ORAL 1700 MG, ORAL Resonance Imaging Abnormal Pituitary Enlargement Pituitary Tumour Benign Somnolence Vomiting Date:09/02/05ISR Number: 4760199-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050606006 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Risperdal Consta PS INTRAMUSCULAR 6 MON Drug Exposure During Risperdal SS ORAL Pregnancy Diazepam C Pregnancy Refusal Of Treatment By Patient Date:09/02/05ISR Number: 4760200-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050602859 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Risperdal Consta PS INTRAMUSCULAR 88 DAY Initial or Prolonged Bone Pain Risperdal SS Drooling Depakote C (at bedtime) Dysphagia Depakote C (in morning) Eye Movement Disorder Feeding Disorder Lacrimation Increased Musculoskeletal Stiffness Pharyngeal Oedema Throat Tightness Urinary Tract Infection 22-Feb-2006 08:20 AM Page: 2647 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/02/05ISR Number: 4760201-XReport Type:Expedited (15-DaCompany Report #NL-JNJFOC-20050805643 Age:2 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Apnoea Risperdal PS UNKNOWN 2 DAY Oxygen Saturation Risperdal SS UNKNOWN 2 DAY Decreased Respiratory Rate Decreased Date:09/02/05ISR Number: 4760202-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050700295 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS ORAL Tavor C ORAL 0.5 - 4mg daily Seroquel C ORAL 100 - 800mg daily Solian C ORAL reported as 400-100mg daily Abilify C ORAL Akineton C Date:09/02/05ISR Number: 4760203-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050803780 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Risperdal PS ORAL Epilepsy Atomoxetine I Date:09/02/05ISR Number: 4760204-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050806489 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Trismus Risperdal PS ORAL Wellbutrin C ORAL Date:09/02/05ISR Number: 4760679-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050802320 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Blinded; Hospitalization - Condition Aggravated Paliperidone Initial or Prolonged Delusion Palmitate PS INTRAMUSCULAR 35 DAY Pancytopenia Placebo SS INTRAMUSCULAR 35 DAY Paranoia Risperdal SS Psychotic Disorder Haldol SS Aspirin SS ORAL Glipizide SS ORAL Lisinopril SS ORAL Gabapentin SS ORAL Gabapentin SS ORAL Gabapentin SS ORAL Gabapentin SS ORAL Gabapentin SS ORAL Simvastatin SS 22-Feb-2006 08:20 AM Page: 2648 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lorazepam SS Benztropine SS Capsaicin C 1 application taken as needed Thiamine C ORAL Docusate Sodium C ORAL Amitriptyline C ORAL Amitriptyline C ORAL Amitriptyline C ORAL Amitriptyline C ORAL Date:09/02/05ISR Number: 4760697-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050806503 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Heat Stroke Risperdal PS ORAL Hemiparesis Elidel C TOPICAL Somnolence Elocon C TOPICAL Date:09/06/05ISR Number: 4761526-4Report Type:Expedited (15-DaCompany Report #2005AP03905 Age:10945 DYGender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Seroquel PS Zeneca Initial or Prolonged Diabetic Ketoacidosis Pharmaceutical ORAL Hypokalaemia Risperdal SS ORAL 339 DAY Risperdal SS ORAL 338 DAY Tegretol SS ORAL 318 DAY Toledomin C ORAL Acinon C ORAL 31 DAY Rohypnol C ORAL Primperan C ORAL 8 DAY Akineton C ORAL Amoban C ORAL Date:09/06/05ISR Number: 4761688-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050300056 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Risperidone PS ORAL Initial or Prolonged Injury Fluoxetin SS Thinking Abnormal Zeldox SS Lorazepam C Date:09/06/05ISR Number: 4761689-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050505294 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Risperdal PS ORAL Initial or Prolonged Vascular Dementia Risperdal SS ORAL Risperdal SS ORAL Risperdal SS ORAL 22-Feb-2006 08:20 AM Page: 2649 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/06/05ISR Number: 4761690-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050806374 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Chromaturia Risperdal PS ORAL Faeces Discoloured Aricept C UNKNOWN Jaundice Zoloft C UNKNOWN Date:09/06/05ISR Number: 4761691-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050806707 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Risperdal Consta PS INTRAMUSCULAR Murder Risperidone SS Date:09/06/05ISR Number: 4761692-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050100908 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Risperdal PS ORAL Initial or Prolonged Blood Cholinesterase Risperdal SS ORAL Other Decreased Risperdal SS ORAL Dysphagia Risperdal SS ORAL Extrapyramidal Disorder Risperdal SS ORAL Hypercholesterolaemia Biperiden Hypokalaemia Hydrochloride C ORAL Hypoproteinaemia Flunitrazepam C ORAL Malnutrition Lorazepam C ORAL Pneumonia Aspiration Mosapride Citrate C ORAL Weight Decreased White Blood Cell Count Increased Date:09/06/05ISR Number: 4761693-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050900332 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperdal Consta PS INTRAMUSCULAR Date:09/06/05ISR Number: 4761694-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050900661 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Idiopathic Risperdal Consta PS INTRAMUSCULAR 131 DAY Thrombocytopenic Purpura Date:09/06/05ISR Number: 4765825-1Report Type:Expedited (15-DaCompany Report #2005119101 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Zoloft (Sertraline) PS ORAL 20 MG (1 D), Initial or Prolonged First Degree Health ORAL Other Facial Palsy Professional Aricept (Donepezil) SS ORAL 10 MG (1D), Hemiplegia ORAL Ischaemic Stroke Meprobamate (Meprobamate) SS ORAL 200 MG (1 D), ORAL 22-Feb-2006 08:20 AM Page: 2650 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperidone (Risperidone) SS ORAL 1 MG (1 D), ORAL Date:09/08/05ISR Number: 4763514-0Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20050805280 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Precocious Puberty Risperdal PS ORAL Nocte Risperdal SS ORAL Risperdal SS ORAL Nocte Date:09/08/05ISR Number: 4763515-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908135 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Risperdal PS Initial or Prolonged Gastric Disorder Risperdal SS Other Gastrointestinal Disorder Risperdal SS Nephrolithiasis Clonidine C UNKNOWN Pain Diltiazem Er C UNKNOWN Pancreatitis Amaryl C UNKNOWN Sinus Tachycardia Zyrtec C UNKNOWN as needed Urinary Tract Infection Allegra C UNKNOWN Date:09/08/05ISR Number: 4763516-4Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050705215 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bladder Cancer Stage Iii Risperdal PS ORAL Other Risperdal SS ORAL Date:09/08/05ISR Number: 4763517-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050900352 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperdal PS ORAL 10 DAY Initial or Prolonged Phosphokinase Increased Akineton Retard C 10 DAY Extrapyramidal Disorder Hypertonia Myoglobinuria Date:09/08/05ISR Number: 4763518-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050900725 Age:63 YR Gender:Male I/FU:I Outcome PT Life-Threatening Amnesia Hospitalization - Chills Initial or Prolonged Drug Ineffective Fall General Physical Health Deterioration Incontinence Pneumonia Salivary Hypersecretion Speech Disorder 22-Feb-2006 08:20 AM Page: 2651 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Stupor Tachyarrhythmia Therapeutic Response Report Source Product Role Manufacturer Route Dose Duration Decreased Risperdal Consta PS INTRAMUSCULAR Urinary Incontinence Risperdal Consta SS INTRAMUSCULAR Waxy Flexibility Clozapin SS UNKNOWN Date:09/08/05ISR Number: 4765661-6Report Type:Direct Company Report #CTU 257809 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Haldol PS Hospitalization - Dyskinesia Risperdal SS Initial or Prolonged Malaise Other Oral Intake Reduced Pyrexia Speech Disorder Starvation Tongue Paralysis Tremor Date:09/09/05ISR Number: 4764876-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050806776 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dispensing Error Risperdal PS UNKNOWN Initial or Prolonged Lethargy Date:09/09/05ISR Number: 4764877-2Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050805496 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS Date:09/09/05ISR Number: 4764878-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050900018 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Risperdal PS ORAL Initial or Prolonged Leukoencephalopathy Nausea Date:09/09/05ISR Number: 4764879-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050900820 Age:29 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depression Risperdal PS Necrosis Ischaemic Seroquel SS Neuroleptic Malignant Syndrome Overdose Renal Failure Acute Rhabdomyolysis 22-Feb-2006 08:20 AM Page: 2652 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/05ISR Number: 4764880-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050801371 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Discomfort Risperidone PS ORAL Initial or Prolonged Diarrhoea Risperidone SS ORAL Faecal Incontinence Risperidone SS ORAL Gastrointestinal Motility Lithium Carbonate C ORAL Disorder Sennoside C ORAL Rectal Prolapse Sennoside C ORAL Sennoside C ORAL Flunitrazepam C ORAL Date:09/09/05ISR Number: 4764881-4Report Type:Expedited (15-DaCompany Report #TW-JNJFOC-20050806351 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blighted Ovum Risperidal PS ORAL Drug Exposure During Risperdal Consta SS INTRAMUSCULAR Pregnancy Date:09/12/05ISR Number: 4766457-1Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20050801410 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Gastric Ulcer Voltaren C ORAL Melaena Torasemide C ORAL Self-Medication Lisinopril C ORAL Carvedilol C ORAL Isosorbide Mononitrate C ORAL Date:09/12/05ISR Number: 4766458-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050900716 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS ORAL Date:09/12/05ISR Number: 4766459-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050900739 Age:26 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Hepatitis C Risperdal Consta SS INTRAMUSCULAR Hepatitis Viral Date:09/12/05ISR Number: 4766460-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050901270 Age:46 YR Gender:Female I/FU:I Outcome PT Hospitalization - Diabetes Mellitus Initial or Prolonged Non-Insulin-Dependent Other Gastric Ulcer Helicobacter Infection Increased Appetite Nausea 22-Feb-2006 08:20 AM Page: 2653 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Risperdal PS ORAL 1 to 3 mg daily Glucophage C Albuterol C Advair C Advair C Loricet C Soma C Tylenol C Tylenol C Tylenol C Tylenol C Tylenol C Tylenol C Tylenol C Tylenol C Tylenol C Tylenol C Tylenol C 2 as necessary Seroquel C Date:09/12/05ISR Number: 4766461-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050502005 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Risperidone PS ORAL Initial or Prolonged Drug Exposure During Risperidone SS ORAL Other Pregnancy Trihexyphenidyl Hydrochloride SS ORAL Risperidone SS ORAL Date:09/12/05ISR Number: 4766462-5Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20050901859 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperdal PS UNKNOWN Other Medication C UNKNOWN Date:09/12/05ISR Number: 4766482-0Report Type:Expedited (15-DaCompany Report #KR-JNJFOC-20050901105 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Reminyl PS ORAL Cardiac Failure Reminyl SS ORAL Congestive Risperdal M-Tabs SS ORAL Femur Fracture Risperdal M-Tabs SS ORAL Date:09/12/05ISR Number: 4768139-9Report Type:Direct Company Report #CTU 257977 Age:22 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization - 22-Feb-2006 08:20 AM Page: 2654 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Dose Duration Impairment/Damage Catatonia Risperdal 1mg PS ORAL 1MG TID PO Muscle Twitching Zoloft C Muscular Weakness Neuroleptic Malignant Syndrome Pyrexia Tachycardia Tardive Dyskinesia Date:09/13/05ISR Number: 4767507-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050804755 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coagulation Factor Risperdal PS ORAL Decreased Risperdal SS ORAL Contusion Platelet Function Test Abnormal Date:09/13/05ISR Number: 4767508-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050900966 Age:70 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Risperdal PS UNKNOWN Femur Fracture Somnolence Date:09/14/05ISR Number: 4768549-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050901957 Age:47 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Event Risperidone PS Date:09/14/05ISR Number: 4768686-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050802816 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Accidental Overdose Risperdal PS ORAL Patient Initial or Prolonged Apnoea accidentally Coma given 3 mL Convulsion prior to Drug Administration Error adverse Electrocardiogram Qt Adderall C UNKNOWN Prolonged Adderall C UNKNOWN Hyponatraemia Adderall C UNKNOWN Hypotension Adderall C UNKNOWN Date:09/14/05ISR Number: 4768687-1Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050805496 Age:89 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperidone M-Tabs PS 22-Feb-2006 08:20 AM Page: 2655 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/14/05ISR Number: 4770764-6Report Type:Direct Company Report #CTU 258165 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Abilify 15 Mg PS ORAL 15 MG DAILY Oral Intake Reduced PO Trismus Risperdal 1 Mg SS ORAL 1 MG TWICE DAILY PO Lorazepam C Simvastatin C Benztropine C Sertraline C Date:09/15/05ISR Number: 4770200-XReport Type:Expedited (15-DaCompany Report #CH-JNJFOC-20050900653 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Risperdal PS ORAL Initial or Prolonged Efexor SS ORAL Seropram SS ORAL Date:09/15/05ISR Number: 4770202-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050901152 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Risperdal PS UNKNOWN Initial or Prolonged Medication Error Parkinson'S Disease Date:09/15/05ISR Number: 4770203-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050901156 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS ORAL Epitomax C Epitomax C Epitomax C Epitomax C Epitomax C Depakine C UNKNOWN Date:09/15/05ISR Number: 4770204-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050901168 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Rigidity Risperdal PS Tremor Reminyl SS Reminyl SS Reminyl SS Metformin C Lantarel C 22-Feb-2006 08:20 AM Page: 2656 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/05ISR Number: 4770205-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050901292 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Date:09/15/05ISR Number: 4770206-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050901536 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Risperdal PS ORAL 1 WK Decreased Date:09/15/05ISR Number: 4770207-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050701525 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acute Pulmonary Oedema Risperdal PS ORAL Rash Erythematous Pyostacine C Date:09/15/05ISR Number: 4770208-4Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20050902186 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Risperdal SS ORAL Melleril C UNKNOWN Date:09/15/05ISR Number: 4770209-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050902316 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Risperdal Consta PS INTRAMUSCULAR Apathy Delusion Disturbance In Attention Impulse-Control Disorder Malaise Mental Status Changes Mutism Schizophrenia, Disorganised Type Speech Disorder Date:09/15/05ISR Number: 4770210-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050902683 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Risperdal PS Date:09/15/05ISR Number: 4770211-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050902754 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal Consta PS INTRAMUSCULAR Decreased 22-Feb-2006 08:20 AM Page: 2657 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/15/05ISR Number: 4770212-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040902336 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Drug Abuser Risperdal Consta SS INTRAMUSCULAR Hallucination Methamphetamine SS Paranoia Risperdal Consta SS INTRAMUSCULAR Concerta C UNKNOWN Date:09/15/05ISR Number: 4770213-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050805237 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Risperdal Consta PS INTRAMUSCULAR 130 DAY Initial or Prolonged Thrombocytopenic Purpura Date:09/15/05ISR Number: 4770214-XReport Type:Periodic Company Report #GB-JNJFOC-20050900661 Age:39 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Idiopathic Risperdal Consta PS INTRAMUSCULAR 131 DAY Thrombocytopenic Purpura Date:09/15/05ISR Number: 4770601-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050901955 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Death Risperdal PS Cardiac Arrest Benztropine SS Cardio-Respiratory Arrest Citalopram SS Cerebrovascular Accident Clonazepam SS Electrocardiogram Qt Lorazepam SS Corrected Interval Quetiapine SS Prolonged Ziprasidone SS Hepatocellular Damage Hyperpyrexia Neuroleptic Malignant Syndrome Rhabdomyolysis Supraventricular Tachycardia Torsade De Pointes Ventricular Fibrillation Date:09/15/05ISR Number: 4770603-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050901956 Age:53 YR Gender:Female I/FU:I Outcome PT Death Blood Creatinine Increased Drug Screen Positive Dyspnoea Haemoglobin Decreased Heart Rate Increased Hypotension Lethargy Lung Infiltration 22-Feb-2006 08:20 AM Page: 2658 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pneumonia Pulmonary Congestion Pyrexia Report Source Product Role Manufacturer Route Dose Duration Vomiting Risperdal PS Oxycodone SS Mirtazapine SS Acetaminophen/ Propoxyphene SS Acetaminophen/ Propoxyphene SS Diazepam SS Date:09/15/05ISR Number: 4770680-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050902338 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Blood Pressure Decreased Acetaminophen PS ORAL Hospitalization - Completed Suicide Acetaminophen SS ORAL Initial or Prolonged Depressed Level Of Risperidone SS ORAL Consciousness Zolpidem SS ORAL Hepatic Necrosis Fluoxetine SS ORAL Intentional Misuse Benzodiazepines C ORAL Overdose Date:09/15/05ISR Number: 4772699-1Report Type:Direct Company Report #CTU 258266 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Risperidone PS 0.25MG QHS 1 YR Muscle Rigidity Lisinopril C Tremor Metoprolol C Trazodone C Mirtazapine C Lovastatin C Glyburide C Gabapentin C Asa C Combivent C Date:09/16/05ISR Number: 4771772-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050902224 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS UNKNOWN Date:09/16/05ISR Number: 4771773-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050902661 Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Wernicke'S Encephalopathy 22-Feb-2006 08:20 AM Page: 2659 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/16/05ISR Number: 4771774-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050802971 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Risperdal PS ORAL Initial or Prolonged Cellulitis Risperdal SS ORAL Other Platelet Count Decreased Flunitrazepam SS ORAL Vomiting Powdered Rhubarb SS ORAL White Blood Cell Count Flunitrazepam SS ORAL Decreased Risperdal SS ORAL Alprazolam C ORAL Diazepam C Date:09/16/05ISR Number: 4771857-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050902348 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Acetaminophen PS ORAL Hospitalization - Cardio-Respiratory Arrest Acetaminophen SS ORAL Initial or Prolonged Completed Suicide Risperdone SS ORAL Confusional State Aspirin SS ORAL Dialysis Zolpidem SS ORAL Hepatic Failure Lamotrigine SS ORAL Hepatic Necrosis Clonazepam SS ORAL Hyperkalaemia Venlafaxine SS ORAL Intentional Misuse Imipramine SS ORAL Lethargy Liver Transplant Mental Status Changes Multiple Drug Overdose Mydriasis Overdose Sinus Tachycardia Date:09/16/05ISR Number: 4771909-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050506155 Age:36 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Paxil Cr PS Glaxosmithkline ORAL 37.5MG At Initial or Prolonged Fall night Muscle Necrosis Risperdal SS UNKNOWN 2.5MG Three Neck Injury times per day Lorazepam C UNKNOWN Ultram C UNKNOWN Hydrocodone C UNKNOWN Date:09/16/05ISR Number: 4772986-7Report Type:Expedited (15-DaCompany Report #2005119101 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Zoloft (Sertraline) PS ORAL 20 MG (1D), Initial or Prolonged First Degree Health ORAL Other Brain Stem Infarction Professional Aricept (Donepezil) SS ORAL 10 MG (1 D), Dysphagia ORAL Facial Palsy Equanil Hemiplegia (Meprobamate) SS ORAL 200 MG (1 D), Ischaemic Stroke ORAL Risperdal (Risperidone) SS ORAL 1 MG (1 D), 22-Feb-2006 08:20 AM Page: 2660 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Date:09/16/05ISR Number: 4773064-3Report Type:Expedited (15-DaCompany Report #2005AL003458 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Foreign Serax (Oxazepam) Initial or Prolonged Diabetes Mellitus Other Tablets, 15 Mg Required Non-Insulin-Dependent (Alpharma) (Serax Intervention to Diabetic Hyperosmolar (Oxazepam) Tablets, Prevent Permanent Coma 15 Mg (Alpharma)) PS Alpharma ORAL 30 MG; QD; PO Impairment/Damage Kadian (Morphine Sulfate Sustained Release) Capsules, 100 Mg (Alpharma) (Kadian (Morphine SS Alpharma ORAL QD; PO Tetrazepam () SS ORAL QD;PO Risperdal () SS ORAL QD;PO Citalopram Hydrochloride () SS 0.5 ML;QD Date:09/16/05ISR Number: 4795535-6Report Type:Periodic Company Report #US-JNJFOC-20050504795 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Consumer Topamax (Topiramate) Confusional State Health Unspecified PS 200 MG, 2 IN Lethargy Professional 1 DAY; Mood Swings Risperdal Paramnesia (Risperidone) Social Avoidant Behaviour Unspecified SS Weight Decreased Date:09/19/05ISR Number: 4772832-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050902743 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Loss Of Consciousness Wrong Drug Administered Date:09/19/05ISR Number: 4772834-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050903054 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Benign Neoplasm Risperdal PS ORAL Date:09/20/05ISR Number: 4773905-XReport Type:Periodic Company Report #EE-JNJFOC-20050500043 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Depression Risperidone Consta PS INTRAMUSCULAR No J & J drug Initial or Prolonged given Seroquel SS ORAL Remeron C ORAL 22-Feb-2006 08:20 AM Page: 2661 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/05ISR Number: 4773906-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050801170 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Coma Risperdal PS ORAL taken for a Hospitalization - Hypokalaemia long period Initial or Prolonged Hyponatraemia of time. Other Partial Seizures With Melperon C reported as a Secondary Generalisation small dose Status Epilepticus Orifil C dose increase Orifil C Date:09/20/05ISR Number: 4773907-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050802320 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pancytopenia Blinded; Hospitalization - Psychotic Disorder Paliperidone Initial or Prolonged Palmitate PS INTRAMUSCULAR 35 DAY Placebo SS INTRAMUSCULAR 35 DAY Risperdal SS Haldol SS Aspirin SS ORAL Glipizide SS ORAL Lisinopril SS ORAL Gabapentin SS ORAL Gabapentin SS ORAL Gabapentin SS ORAL Gabapentin SS ORAL Gabapentin SS ORAL Simvastatin SS Lorazepam SS Benztropine SS Capsaicin C 1 application taken as needed Thiamine C ORAL Docusate Sodium C ORAL Amitriptyline C ORAL Amitriptyline C ORAL Amitriptyline C ORAL Amitriptyline C ORAL Date:09/20/05ISR Number: 4773908-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050903403 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Risperidone PS ORAL "2 dosage form daily" Risperidone SS ORAL "unknown daily" Bifeprunox SS Perphenazine C Benzhexol C Benzhexol C Chlorpromazine C 22-Feb-2006 08:20 AM Page: 2662 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/20/05ISR Number: 4773929-2Report Type:Expedited (15-DaCompany Report #FI-JNJFOC-20050903134 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Risperdal PS ORAL Consciousness Risperdal SS ORAL Herpes Virus Infection Lyrica SS ORAL Neuropathic Pain Risperdal SS ORAL 0.25mg and Somnolence 0.5mg Furesis C ORAL Fosamax C ORAL Emconcor C ORAL Calcichew-D3 Forte C ORAL Calcichew-D3 Forte C ORAL Marevan Forte C ORAL Date:09/20/05ISR Number: 4774062-6Report Type:Expedited (15-DaCompany Report #FR-MERCK-0409FRA00072 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Confusional State Zocor PS Merck & Co., Inc ORAL Initial or Prolonged Dysstasia Fluoxetine Disability Fall Hydrochloride SS ORAL Peripheral Sensorimotor Risperidone SS ORAL Neuropathy Acepromazine And Rhabdomyolysis Aceprometazine And Clorazepate Dipotassium SS ORAL Zopiclone SS ORAL Levothyroxine Sodium C ORAL Date:09/21/05ISR Number: 4774434-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050903427 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Self-Injury Risperdal Consta PS INTRAMUSCULAR Psychotic Disorder Date:09/21/05ISR Number: 4776859-5Report Type:Direct Company Report #CTU 258647 Age:38 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Tardive Dyskinesia Risperidone 2 Mg Tab PS 2 TABS DAILY Date:09/22/05ISR Number: 4775798-3Report Type:Expedited (15-DaCompany Report #2005AC01403 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Drug Reaction Quetiapine PS Zeneca Pharmaceutical ORAL Ziprasidone SS PARENTERAL Risperidone SS 22-Feb-2006 08:20 AM Page: 2663 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/22/05ISR Number: 4777314-9Report Type:Direct Company Report #CTU 258694 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperidone Sa Breast Tenderness 50 Mg Janssen PS Janssen INTRAMUSCULAR 50 MG Q 2 WEEKS IM Risperidone Oral Solution 1 Mg/Ml SS ORAL 3 MG HS PO Apap C Benztropine C Depakote C Lorazepam C Maalox C Date:09/22/05ISR Number: 4778661-7Report Type:Expedited (15-DaCompany Report #HQWYE874523MAY05 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Study Efexor (Venlafaxine Initial or Prolonged Blood Pressure Increased Hydrochloride, Other Dizziness Tablet) PS 150 MG 1X PER Drug Interaction 1 DAY 5 DAY Heart Rate Increased Risperdal Hyperhidrosis (Risperidone, ) SS 1 MG 1X PER 1 Insomnia DAY Restlessness Saroten Tremor (Amitriptyline Vertigo Hydrochloride, ) SS 50 MG 1X PER 1 DAY Remeron Mirtazapine) C Date:09/22/05ISR Number: 4778840-9Report Type:Expedited (15-DaCompany Report #12339 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Circulatory Collapse Foreign Fluphenazine Initial or Prolonged Fall Other Decanoate PS Hypertension Risperdal SS 1 MG BID Urinary Tract Infection Risperdal SS 1 MG DAILY Date:09/22/05ISR Number: 4778964-6Report Type:Expedited (15-DaCompany Report #2005-131810-NL Age:15 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Galactorrhoea Mirtazapine PS 15 MG/30 MG 207 DAY Initial or Prolonged Sinus Tachycardia Risperidone SS 4 WK Tachycardia Quetiapine Fumarate SS 81 DAY Weight Increased Olanzapine SS MG Aripiprazole C Date:09/23/05ISR Number: 4776793-0Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050900360 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Risperidone PS Risperidone SS 22-Feb-2006 08:20 AM Page: 2664 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperidone SS Date:09/23/05ISR Number: 4776794-2Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050901201 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other High Density Lipoprotein Risperidone PS Decreased Risperidone SS Hypercholesterolaemia Risperidone SS Low Density Lipoprotein Increased Date:09/23/05ISR Number: 4776795-4Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050901796 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Risperidone PS Low Density Lipoprotein Increased Date:09/23/05ISR Number: 4776796-6Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050901798 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Risperidone PS Risperidone SS Date:09/23/05ISR Number: 4776797-8Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050901803 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Risperidone PS Risperidone SS Risperidone SS Date:09/23/05ISR Number: 4776798-XReport Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050901804 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Risperidone PS Risperidone SS Risperidone SS Date:09/23/05ISR Number: 4776799-1Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050901806 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Risperidone PS Risperidone SS Risperidone SS 22-Feb-2006 08:20 AM Page: 2665 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/05ISR Number: 4776800-5Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050901809 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Risperidone PS Risperidone SS Date:09/23/05ISR Number: 4776801-7Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050901816 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Risperidone PS Risperidone SS Risperidone SS Date:09/23/05ISR Number: 4776802-9Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050901818 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Risperidone PS Risperidone SS Risperidone SS Date:09/23/05ISR Number: 4776803-0Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050901820 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Risperidone PS Risperidone SS Date:09/23/05ISR Number: 4776804-2Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050901836 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Risperidone PS ORAL Risperidone SS ORAL Glisentide C UNKNOWN Date:09/23/05ISR Number: 4776805-4Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050901838 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypercholesterolaemia Risperidone PS Low Density Lipoprotein Risperidone SS Increased Date:09/23/05ISR Number: 4776806-6Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050902626 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperdal PS Cipramil C 22-Feb-2006 08:20 AM Page: 2666 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/05ISR Number: 4777078-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050605294 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mental Impairment Risperdal PS ORAL 2MG in Initial or Prolonged morning, 1 mg Other in evening Date:09/23/05ISR Number: 4777079-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050604623 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal Consta PS INTRAMUSCULAR Singular Decreased application Risperdal C ORAL Date:09/23/05ISR Number: 4777080-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050804575 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Risperdal Quicklet PS ORAL Initial or Prolonged Hypersensitivity Risperdal Quicklet SS ORAL Rash Risperdal Consta SS INTRAMUSCULAR Swelling Face Risperdal SS ORAL Urticaria Risperdal SS ORAL 2-3ml Urticaria Generalised Thyronajod C Thyronajod C Date:09/23/05ISR Number: 4777081-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050703601 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypertension Risperdal PS ORAL Laboratory Test Risperdal SS ORAL dose reduced. Interference Phaeochromocytoma Tachycardia Date:09/23/05ISR Number: 4777082-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050903143 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Risperdal Consta PS INTRAMUSCULAR Other Prolonged Lithium Carbonate C taken for 20 Somnolence years, one a night. Date:09/23/05ISR Number: 4777083-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050800840 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL General Physical Health Risperdal SS ORAL Deterioration Acerbon C Digimerck C Valium C 22-Feb-2006 08:20 AM Page: 2667 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/05ISR Number: 4777084-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050900739 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Enzyme Increased Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Hepatitis Viral Risperdal Consta SS INTRAMUSCULAR Date:09/23/05ISR Number: 4777085-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050904070 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Strabismus Risperdal PS ORAL Depamide C UNKNOWN Paroxetine C UNKNOWN Date:09/23/05ISR Number: 4777086-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050904078 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholelithiasis Risperdal Consta PS UNKNOWN missed dosage Initial or Prolonged Pancreatic Disorder in hospital. Other Date:09/23/05ISR Number: 4777087-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050904122 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Risperdal PS ORAL Epilepsy Strattera I ORAL Date:09/23/05ISR Number: 4777088-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050904631 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Risperdal PS ORAL Risperdal Consta SS INTRAMUSCULAR Date:09/23/05ISR Number: 4778136-5Report Type:Direct Company Report #CTU 258735 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Macular Mirtazapine 80mg PS 80MG QD Risperdal 0.25mg SS 0.25MG QHS Date:09/23/05ISR Number: 4778995-6Report Type:Expedited (15-DaCompany Report #2005127153 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Chronic Foreign Prednisolone Cardiomegaly Health (Prednisolone) PS ORAL 5 MG ( 5 MG, Cough Professional 1 IN 1D), Sudden Death ORAL Tiotropium Bromide (Tiotropium Bromide) SS RESPIRATORY (INHALATION) INHALATION Risperdal 22-Feb-2006 08:20 AM Page: 2668 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone) SS ORAL 0.5 MG (0.5 MG, 1 IN 1 D),ORAL Bromhexine Hydrochloride (Bromhexine Hydrochloride) C Trandolapril (Trandolarpil) C Sennosides (Sennosides) C Misoprostol (Misoprostol) C Loxoprofen Sodium (Loxoprofen Sodium) C Quetiapine Fumarate (Quetiapine Fumarate) C Bucillamine (Bucillamine) C Ziopiclone (Zopiclone) C Date:09/26/05ISR Number: 4778426-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050904064 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperdal PS ORAL Initial or Prolonged Phosphokinase Increased Other Blood Creatinine Increased Electrolyte Imbalance Date:09/26/05ISR Number: 4778427-8Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20050904068 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chills Risperdal PS ORAL Initial or Prolonged Dizziness Saroten C ORAL Drug Interaction Efexor I ORAL 5 DAY Hyperhidrosis Insomnia Restlessness Somnolence Vertigo Date:09/26/05ISR Number: 4778429-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050904102 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal Consta PS INTRAMUSCULAR Neutropenia Risperdal Consta SS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Temesta C 22-Feb-2006 08:20 AM Page: 2669 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/05ISR Number: 4778430-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050904138 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Risperdal PS ORAL Life-Threatening Road Traffic Accident Date:09/26/05ISR Number: 4778431-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050904156 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Risperdal SS ORAL Equanil C UNKNOWN Kardegic C UNKNOWN Renitec C UNKNOWN Noctamide C UNKNOWN Date:09/26/05ISR Number: 4778432-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050702517 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Inflammatory Bowel Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Disease Parkinane C Disability Solupred C 0.5 to 1.5 mg daily Date:09/26/05ISR Number: 4778433-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050901536 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Risperdal PS ORAL 8 DAY Initial or Prolonged Risperdal SS ORAL 8 DAY Other Clozapine SS Date:09/26/05ISR Number: 4778434-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050802485 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Infarction Risperdal PS ORAL Since 6 Initial or Prolonged Cerebral Ischaemia months Other Headache Risperdal SS ORAL Hemiparesis Visual Disturbance Date:09/26/05ISR Number: 4778435-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050806374 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Other Faeces Discoloured Aricept C UNKNOWN Haemochromatosis Zoloft C UNKNOWN Hepatic Cirrhosis Hepatic Neoplasm Malignant Jaundice 22-Feb-2006 08:20 AM Page: 2670 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/05ISR Number: 4778436-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050201087 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Risperdal PS ORAL 106 DAY Initial or Prolonged Hyponatraemia Ativan C Other Polydipsia Psychogenic Rivotril C Date:09/26/05ISR Number: 4778437-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050904808 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrioventricular Block Risperdal PS ORAL First Degree Depakote C Electrocardiogram Qt Trazadone C Prolonged Date:09/26/05ISR Number: 4778438-2Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050901331 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Glucose Decreased Risperidone PS ORAL Hypercholesterolaemia Risperidone SS ORAL Low Density Lipoprotein Increased Date:09/26/05ISR Number: 4778586-7Report Type:Expedited (15-DaCompany Report #2005SE04772 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Seroquel PS Zeneca Initial or Prolonged Blood Glucose Increased Pharmaceutical ORAL 300+400 MG Blood Prolactin Increased DAILY 81 DAY Galactorrhoea Remeron SS ORAL 207 DAY Glucose Urine Present Risperdal SS ORAL 0.5-1 MG Headache TWICE DAILY 28 DAY Nausea Zyprexa SS ORAL 15-20 MG IN Orthostatic Hypotension THE EVENING Sinus Tachycardia Sleep Disorder Syncope Weight Increased Date:09/26/05ISR Number: 4779031-8Report Type:Expedited (15-DaCompany Report #US-ABBOTT-03P-163-0228662-00 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Condition Aggravated Depakote PS 1 WK Initial or Prolonged Dermatitis Bullous Risperidone SS Erythema Multiforme Risperidone SS Fall Quetiapine SS Joint Stiffness Quetiapine SS Neuroleptic Malignant Syndrome 22-Feb-2006 08:20 AM Page: 2671 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/05ISR Number: 4780486-3Report Type:Expedited (15-DaCompany Report #2005128522 Age:30 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Gabapentin Drug Toxicity Health (Gabapentin) PS Intentional Misuse Professional Cocaine (Cocaine) SS Multiple Drug Overdose Risperidone Respiratory Arrest (Risperidone) SS Date:09/26/05ISR Number: 4780952-0Report Type:Direct Company Report #CTU 258895 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Risperdal (Janssen) PS Janssen ORAL 4 MG PO BID Life-Threatening Loss Of Consciousness Zyprexa (Eli Lilly) SS Eli Lilly ORAL 10 MG PO TID Other Nausea Vomiting Weight Increased Date:09/26/05ISR Number: 4781052-6Report Type:Expedited (15-DaCompany Report #S05-FRA-03476-01 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Foreign Seropram (Citalopram Initial or Prolonged Diabetic Hyperosmolar Health Hydrobromide) PS 0.5 ML QD Coma Professional Seresta (Oxazepam) SS ORAL 3 UNITS QD PO Other Risperdal (Risperidone) SS ORAL 1 UNITS QD PO Myolastan (Tetrazepam) SS ORAL 1 UNITS QD PO Skenan (Morphine Sulfate) SS 2 UNITS Date:09/26/05ISR Number: 4781094-0Report Type:Expedited (15-DaCompany Report #A044-002-005750 Age:64 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Asthenia Foreign Aricept (Donepezil Drug Interaction Health Hydrochloride) PS ORAL 5 MG, 1 IN 1 Radial Nerve Palsy Professional D, ORAL Tremor Fluoxetine (Fluoxetine) SS ORAL 20 MG, ORAL ; LONG TERM Risperidone (Risperidone) SS ORAL ORAL ; LONG TERM Date:09/27/05ISR Number: 4779825-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050904706 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiovascular Disorder Risperdal PS UNKNOWN 22-Feb-2006 08:20 AM Page: 2672 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/05ISR Number: 4779826-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050904912 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Risperdal PS ORAL Initial or Prolonged Facial Bones Fracture Stilnox SS Fall Lysanxia SS Upper Limb Fracture Cordarone C Seropram C ORAL dose= tablet Exelon C ORAL dose= tablet Date:09/27/05ISR Number: 4779827-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050905168 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Risperdal PS ORAL (dose divided Initial or Prolonged Cardiac Disorder and taken Other Dehydration three times Oedema daily) Somnolence Risperdal SS ORAL Weight Decreased Date:09/27/05ISR Number: 4779828-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050800751 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Administration Error Risperdal Consta PS INTRAMUSCULAR "for the past Initial or Prolonged Hospitalisation few months" Date:09/27/05ISR Number: 4779829-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050900725 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Chills Risperdal Consta PS INTRAMUSCULAR Hospitalization - Drug Ineffective Risperdal Consta SS INTRAMUSCULAR Initial or Prolonged Fall Clozapin SS UNKNOWN General Physical Health Deterioration Pneumonia Salivary Hypersecretion Speech Disorder Tachyarrhythmia Urinary Incontinence Waxy Flexibility Date:09/27/05ISR Number: 4780909-XReport Type:Direct Company Report #CTU 258948 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Restlessness Risperdal 1.5 Mg Q 12 H PS 1.5 MG Q 12 H PO 22-Feb-2006 08:20 AM Page: 2673 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/27/05ISR Number: 4782009-1Report Type:Expedited (15-DaCompany Report #2005129232 Age:57 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Doxepin (Caps) Intentional Misuse Health (Doxepin) PS Multiple Drug Overdose Professional Enalapril (Enalapril) SS Risperidone (Risperidone0 SS Date:09/27/05ISR Number: 4782853-0Report Type:Expedited (15-DaCompany Report #2005128241 Age:32 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Therapeutic Agent Literature Ziprasidone (Caps) Toxicity Health (Ziprasidone) PS Professional Quetiapine (Quetiapine) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Risperidone (Risperidone) SS Date:09/28/05ISR Number: 4781026-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050905553 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Risperdal PS ORAL Decreased Zaponex SS ORAL Date:09/28/05ISR Number: 4781616-XReport Type:Expedited (15-DaCompany Report #2005UW14207 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Seroquel PS Zeneca Convulsion Pharmaceutical ORAL Mydriasis Risperdal SS Tachycardia Effexor Xr SS Date:09/28/05ISR Number: 4783065-7Report Type:Direct Company Report #CTU 259037 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Neuroleptic Malignant Risperdal PS Hospitalization - Syndrome Haldol SS Initial or Prolonged Haldol C Trazodone C Wellbutrin C Prozac C Risperdal C 22-Feb-2006 08:20 AM Page: 2674 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/05ISR Number: 4782387-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050607506 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Homicidal Ideation Risperdal PS ORAL Physical Assault Risperdal SS ORAL Date:09/29/05ISR Number: 4782388-5Report Type:Expedited (15-DaCompany Report #PT-JNJFOC-20050905564 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Screen Positive Risperdal PS UNKNOWN Date:09/29/05ISR Number: 4782390-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050906231 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Risperdal PS Initial or Prolonged Fall Warfarin C 8 mg Mon, Syncope Tue, Wed., Thurs and Fri. 9 mg Sat. and Sun. Effexor C Flexaril C Xanax C Toprol Xl C Lasix C Florinef C Proamatine C Klor-Con C Neurontin C Oxycontin C Cortisone C 25 mg 1200, 1/2 tab at 2200 Hydrochloroquine C Zyrtec C Prevacid C Synthroid C 0.25 mcg Mon, Wed, and Fri. 0.50 mcg Tue, Thurs, Sat, and Sun. Date:09/29/05ISR Number: 4783230-9Report Type:Expedited (15-DaCompany Report #2005UW14202 Age:72 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Confusional State Seroquel PS Zeneca Depression Pharmaceutical ORAL 1 MON Drug Interaction Loxapine C Pathological Fracture Citalopram I ORAL Psychotic Disorder Neurontin I ORAL Risperdal I ORAL 22-Feb-2006 08:20 AM Page: 2675 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/29/05ISR Number: 4783566-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050904628 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal PS ORAL Phosphokinase Increased Haloperidol SS ORAL Myoglobin Urine Present Olanzapine SS ORAL Renal Failure Carbamazepine SS ORAL Loxoprofen Sodium SS Date:09/29/05ISR Number: 4783567-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050904906 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pituitary Tumour Benign Risperdal Consta PS INTRAMUSCULAR drug temporarily held 87 DAY Date:09/29/05ISR Number: 4783568-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050905501 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Failure Risperdal PS ORAL Initial or Prolonged Theophylline C ORAL Other Nitrazepam C ORAL Nifedipine C ORAL Bunazosin Hydrochloride C ORAL Distigmine Bromide C ORAL Chlormadinone Acetate C ORAL Disopyramide C ORAL Pravastatin Sodium C ORAL Famotidine C ORAL Date:09/29/05ISR Number: 4784457-2Report Type:Direct Company Report #CTU 259146 Age:43 YR Gender:Not SpecifiI/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Oedema Peripheral Resperdal Consta I-M Weight Increased -50 Mg Every 14 Days PS Venlafaxin F-150 Mg Twice N Day SS Date:09/29/05ISR Number: 4784869-7Report Type:Direct Company Report #CTU 259130 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Erythematous Mirtazapine 80 Mg PS 80 MG QD Rash Generalised Risperdal 0.25 Mg SS 0.25 MG QHS Date:09/29/05ISR Number: 4785309-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050502966 Age:1 DY Gender:Male I/FU:F Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 2676 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Congenital Anomaly Other PT Report Source Product Role Manufacturer Route Dose Duration Caesarean Section Foreign Risperdal Congenital Anomaly Literature (Risperidone) Drug Exposure During Health Tablets PS ORAL 2 MG, IN 1 Pregnancy Professional DAY, ORAL Incubator Therapy Haloperidol Oxygen Saturation (Haloperidol) Decreased Injection SS INTRAMUSCULAR 5MG, IN 1 Patent Ductus Arteriosus DAY, Pneumothorax INTRAMUSCULAR Haloperidol (Haloperidol) Tablets SS ORAL 4.5 MG, IN 1 DAY, ORAL Biperiden Hydrochloride (Biperiden Hydrochloride) Tablets SS ORAL 3 MG, IN 1 DAY, ORAL Chlorpromazine-Prome thazine (Chlorpromazine) Tablets SS ORAL 1 DOSE (S), IN 1 DAY, ORAL Estazolam (Estazolam) Tablets SS ORAL 2 MG, IN 1 DAY, ORAL Chlorpromazine Hibenzate (Chlorpromazine) Tablets SS ORAL 25 MG, IN 1 DAY, ORAL Brotizolam (Brotizolam) Tablets SS ORAL 0.5 MG, IN 1 DAY, ORAL Nitrazepam (Nitrazepam) Tablets SS ORAL 10 MG, IN 1 DAY, ORAL Fluphenazine Enanthate (Fluphenazine Enantate) Injection SS INTRAMUSCULAR 25 MG, IN 1 DAY, INTRA-MUSCULA R Date:09/30/05ISR Number: 4784328-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050702005 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Risperdal PS Corrected Interval Risperdal SS (reduced to 2 Prolonged mg at bedtime) 22-Feb-2006 08:20 AM Page: 2677 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/30/05ISR Number: 4784329-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050705646 Age:48 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Risperdal Consta PS INTRAMUSCULAR Anal Cancer Lovastatin C Paxil C Date:09/30/05ISR Number: 4784330-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050905899 Age:55 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Risperdal PS ORAL Initial or Prolonged Hypotonia Atarax C UNKNOWN Respiratory Distress Seropram C UNKNOWN Forlax C UNKNOWN 2 sachets Tranxene C UNKNOWN Tegretol C UNKNOWN Diantalvic C UNKNOWN Diantalvic C UNKNOWN 2 capsules on 22 Sep evening Date:09/30/05ISR Number: 4784975-7Report Type:Expedited (15-DaCompany Report #PHBS2005DE14220 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Amnesia Clozapine PS Novartis Sector: Hospitalization - Bedridden Pharma UNKNOWN 50 mg/d Initial or Prolonged Chills Risperdal SS INTRAMUSCULAR 37.5 mg 1 in Fall 2 week 87840MIN General Physical Health Risperdal SS INTRAMUSCULAR 50 mg 1 in 2 Deterioration week 153 DAY Pneumonia Salivary Hypersecretion Speech Disorder Stupor Tachyarrhythmia Urinary Incontinence Waxy Flexibility Date:09/30/05ISR Number: 4785032-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050905518 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Risperdal PS ORAL 99 DAY Initial or Prolonged Cytolytic Hepatitis Reminyl SS ORAL 99 DAY Dehydration Lasilix SS ORAL 55 DAY General Physical Effexor SS ORAL 2 cp per day 55 DAY Condition Ebixa C UNKNOWN Orthostatic Hypotension Triatec C UNKNOWN Renal Failure Mopral C UNKNOWN for several years Plavix C UNKNOWN for several years Corvasal C UNKNOWN for several years Arcalion C UNKNOWN Diantalvic C UNKNOWN 22-Feb-2006 08:20 AM Page: 2678 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Diantalvic C UNKNOWN Date:09/30/05ISR Number: 4785085-5Report Type:Expedited (15-DaCompany Report #DK-JNJFOC-20050906511 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Risperdal Consta PS INTRAMUSCULAR Sudden Death Orap C ORAL Seroquel C Pantoloc C Novynette C Gaviscon C Oxazepam C 15 mg p.n.max. x 4 Pinex C 1 g p.n. max.x 3 Truxal C 50-100 mg p.n. max 250mg Primperam C 20 mg p.n. max. 2 Gaviscon C Mixt 15 ml p.n. max. x 3 Rivotril C Novynette C Disipal C Risperdal I ORAL Date:09/30/05ISR Number: 4785850-4Report Type:Expedited (15-DaCompany Report #DKLU1017161 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Self-Injury Foreign Risperidone PS ORAL 6 MG Hospitalization - Skin Laceration Study MILLIGRAM (S) Initial or Prolonged Suicide Attempt Health ORAL 65 DAY Professional Timonil Other (Carbamazepine) C Date:09/30/05ISR Number: 4785851-6Report Type:Expedited (15-DaCompany Report #DKLU1016685 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Risperidone PS ORAL 5 MG Fall Study MILLIGRAM (S) Injury Asphyxiation Health ORAL 271 DAY Professional Other Date:09/30/05ISR Number: 4785853-XReport Type:Expedited (15-DaCompany Report #DKLU1017221 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abdominal Injury Foreign Risperidone Anxiety Study (Injection) PS INTRAMUSCULAR (50 MG Self Mutilation Health MILLIGRAM Professional (S), EVERY Other 2ND WEEK) 22-Feb-2006 08:20 AM Page: 2679 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report INTRAMUSCULAR Xanax (Alprazolam) (Tablet) C Depakote (Valproate Semisodium) (Tablet) C Zoloft (Sertraline Hydrochloride) (Tablet) C Date:09/30/05ISR Number: 4786233-3Report Type:Expedited (15-DaCompany Report #DSA_27127_2005 Age:57 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Enalapril PS ORAL DF; PO Drug Level Above Health Doxepin SS DF, PO Therapeutic Professional Risperidone SS PO Intentional Misuse Overdose Date:09/30/05ISR Number: 4786851-2Report Type:Expedited (15-DaCompany Report #FRWYE001623SEP05 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abulia Health Effexor (Venlafaxine Initial or Prolonged Alanine Aminotransferase Professional Hydrochloride) PS ORAL 2 DOSE 1X PER Increased Other 1 DAY ORAL Aspartate Lasilix (Furosemide) SS ORAL 20 MG 2X PER Aminotransferase 1 DAY ORAL 54 DAY Increased Reminyl Asthenia (Galantamine) SS ORAL 12 MG 2X PER Blood Amylase Increased 1 DAY ORAL 98 DAY Blood Bilirubin Increased Risperdal Blood Sodium Increased (Risperidone) SS ORAL 0.5 MG 1X PER Dehydration 1 DAY ORAL 98 DAY Gamma-Glutamyltransferase Ebixa (Memantine Increased Hydrochloride) C General Physical Health Triatec (Ramipril) C Deterioration Mopral (Omeprazole) C Orthostatic Hypotension Plavix (Clopidogrel) C Renal Failure Acute Arcalion White Blood Cell Count (Bisbutiamine ) C Increased Di-Antalvic (Dextroproxyphene Hydrochloride/Parace tamol C Date:09/30/05ISR Number: 4787074-3Report Type:Expedited (15-DaCompany Report #DKLU1016998 Age:62 YR Gender:Female I/FU:F Outcome PT Hospitalization - Constipation Initial or Prolonged Eosinophil Count Increased Haemoglobin Decreased Lymphocyte Count Decreased Lymphocyte Percentage Decreased Neutrophil Count 22-Feb-2006 08:20 AM Page: 2680 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Neutrophil Percentage Increased Pain Report Source Product Role Manufacturer Route Dose Duration Red Blood Cell Count Study Risperidone PS ORAL 2 Decreased Health MILLIGRAM(S), Uterovaginal Prolapse Professional ORAL Senokot (Senna Fruit) (Tablet) C Sangobion (Sangobion) (Tablet) C Date:09/30/05ISR Number: 4787076-7Report Type:Expedited (15-DaCompany Report #DKLU1016894 Age:41 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Carcinoma In Situ Study Risperidone PS ORAL 2 MG Initial or Prolonged Cervical Dysplasia Health MILLIGRAM Professional (S), ORAL Lorazepam (Lorazepam) C Procyclidine (Procyclidine) C Date:09/30/05ISR Number: 4787077-9Report Type:Expedited (15-DaCompany Report #DKLU1016814 Age:18 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination, Visual Study Risperidone PS ORAL SEE IMAGE 9 DAY Self Mutilation Health Suicide Attempt Professional Date:09/30/05ISR Number: 4787080-9Report Type:Expedited (15-DaCompany Report #DKLU1017073 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Misuse Study Risperidone PS ORAL ORAL 3 DAY Overdose Health Biperidene Suicide Attempt Professional (Biperiden) SS 20 MILLIGRAM (S) Date:10/03/05ISR Number: 4786655-0Report Type:Direct Company Report #CTU 259455 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dizziness Risperdal Tablets 3 Menstruation Irregular Mg 60 Ct Bt PS Mfd By Janssen 2 TABLETS Poor Quality Drug ONCE DAILY Administered Vision Blurred Date:10/03/05ISR Number: 4786673-2Report Type:Direct Company Report #CTU 259383 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Visual Disturbance Risperdal 1mg Janssen PS Janssen ORAL 1MG ONCE 22-Feb-2006 08:20 AM Page: 2681 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAILY PO Date:10/03/05ISR Number: 4786802-0Report Type:Direct Company Report #CTU 259443 Age:65 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Risperdal PS ORAL 2MG BID PO Initial or Prolonged Haematemesis Cogentin C Liver Function Test Prevacid C Abnormal Date:10/03/05ISR Number: 4788238-5Report Type:Expedited (15-DaCompany Report #FRWYE001623SEP05 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abulia Foreign Effexor PS ORAL 2 DOSE 1X PER Initial or Prolonged Alanine Aminotransferase Health 1 DAY ORAL Increased Professional Lasilix Aspartate Other (Furosemide) SS ORAL 20 MG 2X PER Aminotransferase 1 DAY ORAL 54 DAY Increased Reminyl Asthenia (Galantamin) SS ORAL 12 MG 2X PER Blood Alkaline 1 DAY ORAL 98 DAY Phosphatase Increased Risperdal Blood Amylase Increased (Risperidone) SS ORAL 0.5 MG 1X PER Blood Bilirubin Increased 1 DAY ORAL 98 DAY Blood Sodium Increased Ebixa Dehydration (Memantine Fall Hydrochloride) C Gamma-Glutamyltransferase Triatec Increased (Ramipril) C General Physical Health Mopral Deterioration (Omeprazole) C Orthostatic Hypotension Plavix Protein Total Increased (Clopidogrel Renal Failure Acute Sulfate) C White Blood Cell Count Arcalion Increased (Bisbutiamine) C Di-Antalvic (Dextropropoxyphene Hydrochloride/Parace tamol) C Date:10/04/05ISR Number: 4786805-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050906924 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Risperdal PS Renal Failure Chronic Lithium SS Date:10/04/05ISR Number: 4786806-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051000022 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Mass Risperdal PS ORAL 3 YR Depression Ativan C Lexapro C 22-Feb-2006 08:20 AM Page: 2682 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/05ISR Number: 4786834-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050906943 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal PS ORAL Galactocele Lamictal C Date:10/04/05ISR Number: 4787053-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050906843 Age:58 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Marrow Depression Risperdal PS Leukopenia Lithium C Cogentin C Xanax C Date:10/04/05ISR Number: 4787469-8Report Type:Expedited (15-DaCompany Report #FR-SANOFI-SYNTHELABO-A02200502478 Age:86 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Akinesia Stilnox PS ORAL Initial or Prolonged Arthropathy Risperdal SS ORAL 0.3 mg Disorientation Lysanxia SS ORAL 30 mg Facial Bones Fracture Cordarone C ORAL Fall Seropram C ORAL Injury Exelon C ORAL 2 DF Date:10/04/05ISR Number: 4788991-0Report Type:Expedited (15-DaCompany Report #DSA_27153_2005 Age:86 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Lorazepam PS ORAL DF PO Multiple Drug Overdose Health Risperidone SS ORAL DF PO Professional Aspirin SS ORAL DF PO Date:10/04/05ISR Number: 4789041-2Report Type:Expedited (15-DaCompany Report #DSA_70755_2005 Age:53 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Literature Oxycodone PS ORAL DF UNK PO Health Risperidone SS ORAL DR UNK PO Professional Mirtazapine SS ORAL DF UNK PO Date:10/05/05ISR Number: 4788598-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050906244 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Artery Dissection Risperdal Consta PS INTRAMUSCULAR Coordination Abnormal Malaise 22-Feb-2006 08:20 AM Page: 2683 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/05/05ISR Number: 4788599-7Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20050906504 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anuria Risperdal PS ORAL Initial or Prolonged Blood Creatine Other Phosphokinase Increased Depressed Level Of Consciousness Dizziness Masked Facies Nephrotic Syndrome Overdose Renal Failure Schizophrenia Date:10/05/05ISR Number: 4788600-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050905168 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Risperdal PS ORAL (dose divided Initial or Prolonged Cardiac Disorder and taken Other Dehydration three times Oedema daily) Somnolence Risperdal SS ORAL Weight Decreased Risperdal SS ORAL Amlodipine Besilate C ORAL Date:10/05/05ISR Number: 4788601-2Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20050902186 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Risperdal PS ORAL Risperdal SS ORAL Melleril C UNKNOWN Oxazepam C Olanzapine C Date:10/06/05ISR Number: 4790046-6Report Type:Expedited (15-DaCompany Report #FI-JNJFOC-20050903134 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Depressed Level Of Risperdal PS ORAL Consciousness Risperdal SS ORAL Somnolence Lyrica SS ORAL Risperdal SS ORAL 0.25mg and 0.5mg Furesis C ORAL Fosamax C ORAL Emconcor C ORAL Calcichew-D3 Forte C ORAL Calcichew-D3 Forte C ORAL Marevan Forte C ORAL 22-Feb-2006 08:20 AM Page: 2684 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/05ISR Number: 4790047-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050704918 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetes Mellitus Risperdal PS ORAL Other Insulin-Dependent Risperdal SS ORAL Extrapyramidal Disorder Risperdal SS ORAL Ketoacidosis Taxilan SS ORAL maximum dose, then decreased slowly Taxilan SS ORAL slowly increasing dosage Risperdal SS ORAL Risperdal SS ORAL 1-0-2 mg daily Akineton C ORAL Akineton C ORAL Akineton C ORAL Akineton C ORAL Tavor C ORAL 0-0-0.5 mg Tavor C ORAL 0.5-0-0.5 mg Tavor C ORAL Tavor C ORAL 0-0-0.5 mg Date:10/06/05ISR Number: 4790048-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050901156 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS ORAL Epitomax C Depakine C UNKNOWN Date:10/06/05ISR Number: 4790081-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050906344 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pyrexia Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Respiratory Disorder Urticaria Date:10/06/05ISR Number: 4790082-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051000903 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal PS ORAL Isosorbide Dinitrate C ORAL Date:10/06/05ISR Number: 4792004-4Report Type:Expedited (15-DaCompany Report #PAR_0264_2005 Age:57 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Doxepin PS ORAL DF UNK PO Overdose Health Enalapril SS ORAL DF UNK PO Professional Risperidone SS ORAL DF UNK PO 22-Feb-2006 08:20 AM Page: 2685 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/06/05ISR Number: 4792208-0Report Type:Expedited (15-DaCompany Report #T05-USA-03494-01 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Study Memantine (Open Initial or Prolonged Bipolar Disorder Health Label) (Memantine) PS ORAL 30 MG QD PO Condition Aggravated Professional Risperidone SS ORAL 3 MG BID PO Contusion Acetaminophen C Depression Zolpidem C Fall Humulin Regular Mania (Insulin Human) C Pressure Of Speech Protonix "Pharmacia" (Pantoprazole) C Metformin C Lisinopril C Reglan (Metoclopramide) C Phenergan "Aventis Pharma" (Promethazine Hydrochloride) C Date:10/06/05ISR Number: 4793405-0Report Type:Expedited (15-DaCompany Report #AND_0082_2005 Age:53 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Overdose Literature Mirtazapine PS ORAL DF UNK PO Health Oxycodone SS ORAL DF UNK PO Professional Risperidone SS ORAL DF UNK PO Date:10/06/05ISR Number: 4793499-2Report Type:Expedited (15-DaCompany Report #PAR_0279_2005 Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Fluoxetine PS ORAL DF PO Multiple Drug Overdose Health Olanzapine SS ORAL DF PO Professional Risperidone SS ORAL DF PO Date:10/06/05ISR Number: 4795030-4Report Type:Expedited (15-DaCompany Report #T05-USA-03494-01 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Study Memantine (Open Initial or Prolonged Bipolar Disorder Health Label) (Memantine) PS ORAL 30 MG QD PO Condition Aggravated Professional Risperidone SS ORAL 3 MG BID PO Contusion Acetaminophen C Depression Zolpidem C Fall Humulin Regular Mania (Insulin Human) C Pressure Of Speech Protonix "Pharmacia" (Pantoprazole) C Metformin C Lisinopril C Reglan (Metoclopramide) C Phenergan "Aventis Pharma" (Promethazine Hydrochloride) C 22-Feb-2006 08:20 AM Page: 2686 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/05ISR Number: 4791013-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050906788 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL reported as 'low dosage' Date:10/07/05ISR Number: 4791014-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051000131 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Corneal Deposits Risperdal Consta PS INTRAMUSCULAR 2 YR Intraocular Pressure Increased Lenticular Opacities Date:10/07/05ISR Number: 4791015-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051000153 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Risperdal PS ORAL Splenic Haematoma Trimethoprim C ORAL Date:10/07/05ISR Number: 4791016-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051000728 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Difficulty In Walking Risperdal PS ORAL Dyskinesia Teralithe C UNKNOWN Dysphonia Tremor Date:10/07/05ISR Number: 4791832-9Report Type:Expedited (15-DaCompany Report #KR-JNJFOC-20050703279 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Interaction Reminyl PS ORAL 183 DAY Pneumonia Aspiration Reminyl SS ORAL 183 DAY Respiratory Distress Risperidone SS ORAL 213 DAY Stupor Stilnox SS ORAL 14 DAY Risperidone SS ORAL 213 DAY Reminyl SS ORAL 183 DAY Plavix C ORAL 70 DAY Date:10/07/05ISR Number: 4791847-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050902982 Age:66 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Superior Vena Caval Risperdal PS ORAL 5 MON Initial or Prolonged Occlusion Zolpidem Tartrate C ORAL Brotizolam C ORAL Trazodone Hydrochloride C ORAL Fluvoxamine Maleate C ORAL Cloxazolam C 22-Feb-2006 08:20 AM Page: 2687 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/05ISR Number: 4791848-2Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20050906354 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Phosphokinase Increased Risperdal Consta SS INTRAMUSCULAR Leukocytosis Vival C Pneumonia Akineton C taken prn Pyrexia Respiration Abnormal Respiratory Arrest Tachycardia Date:10/07/05ISR Number: 4791849-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051000120 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS Neuroplant C UNKNOWN Date:10/07/05ISR Number: 4791850-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051000312 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Stevens-Johnson Syndrome Risperdal PS ORAL Allopurinol C "Multiple" Concomitant Medications C Date:10/10/05ISR Number: 4792468-6Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0394976A Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Osmolarity Deroxat PS Glaxosmithkline ORAL 20MG Per day 171 DAY Initial or Prolonged Decreased Risperdal SS Other ORAL .5MG At night Heart Rate Decreased Carteol C Hyperkalaemia Spagulax C Hyponatraemia Malaise Suicide Attempt Date:10/10/05ISR Number: 4792502-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051000148 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Risperdal PS ORAL 193 DAY Initial or Prolonged Hand Fracture Daflon SS ORAL Pancytopenia Atarax SS ORAL Detensiel C Aldalix C Aldalix C dose= 1 tablet/day Mysoline C Mysoline C Di-Antalvic C Di-Antalvic C 22-Feb-2006 08:20 AM Page: 2688 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/10/05ISR Number: 4792503-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051000322 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Cryptorchism Risperdal PS TRANSPLACENTAL dose= 1-2mg Other Drug Exposure During daily Pregnancy Date:10/10/05ISR Number: 4792504-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051000327 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Abortion Spontaneous Risperdal PS TRANSPLACENTAL Other Drug Exposure During Pregnancy Trisomy 13 Date:10/10/05ISR Number: 4792505-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051000682 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Risperdal PS ORAL Loss Of Consciousness Cogentin C Tremor Zoloft C Date:10/10/05ISR Number: 4792506-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051000684 Age:11 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diplopia Risperdal PS ORAL (soon Dizziness increased to Vomiting 0.5 mg daily) White Blood Cell Count Risperdal SS ORAL (missed Decreased "several doses" due to Hurricaine Rita and Date:10/10/05ISR Number: 4792507-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051000717 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Uterine Polyp Risperdal Consta PS INTRAMUSCULAR Date:10/10/05ISR Number: 4792508-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050402219 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Risperdal Consta PS INTRAMUSCULAR 71 DAY Drug Exposure During Risperdal Consta SS INTRAMUSCULAR prior to Pregnancy enrollment in study (dose not specified) 71 DAY Risperidone C ORAL 22-Feb-2006 08:20 AM Page: 2689 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/10/05ISR Number: 4792509-6Report Type:Expedited (15-DaCompany Report #SK-JNJFOC-20051000947 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Death Risperidone PS INTRAMUSCULAR Risperidone SS ORAL 14 DAY Date:10/10/05ISR Number: 4792510-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050704140 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Risperdal PS ORAL Life-Threatening Atrial Fibrillation Risperdal SS ORAL Brain Herniation Risperdal SS ORAL Cerebral Artery Occlusion Haldol SS "2 dosage Cerebral Infarction form per day" Fibrin D Dimer Increased Risperdal SS ORAL Gaze Palsy Risperdal SS ORAL Mania Levomepromazine Respiratory Disorder Maleate C ORAL Levomepromazine Maleate C ORAL Levomepromazine Maleate C ORAL Levomepromazine Maleate C INTRAMUSCULAR Flunitrazepam C ORAL Date:10/10/05ISR Number: 4792831-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051000632 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Risperdal PS ORAL Cyanosis Risperdal SS ORAL Foaming At Mouth Date:10/10/05ISR Number: 4792852-0Report Type:Expedited (15-DaCompany Report #200517003US Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Lantus PS Aventis Initial or Prolonged Paranoia Pharmaceuticals Inc. SUBCUTANEOUS Dose unit: Sepsis units Somnolence Zoloft SS dose: NOT PROVIDED Risperdal SS dose: NOT PROVIDED Baclofen C dose: NOT PROVIDED Diflucan C dose: NOT PROVIDED Mvi /Usa/ C dose: NOT PROVIDED Zinc C dose: NOT PROVIDED Omeprazole C dose: NOT PROVIDED 22-Feb-2006 08:20 AM Page: 2690 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vitamin C C dose: NOT PROVIDED Lasix C dose: NOT PROVIDED Vancomycin C dose: UNKNOWN Maxaquin C dose: NOT PROVIDED Date:10/11/05ISR Number: 4793408-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050405079 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Activated Partial Risperdal Consta PS INTRAMUSCULAR Prior to Thromboplastin Time enrolment in Prolonged the study. Coagulopathy Risperdal Consta SS INTRAMUSCULAR Risperidone C ORAL Date:10/11/05ISR Number: 4794365-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051000152 Age:78 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Osmolarity Risperdal PS ORAL Initial or Prolonged Decreased Spagulax C UNKNOWN Drug Interaction Carteol Collyrium C Hyperkalaemia Deroxat I ORAL Hyponatraemia Malaise Date:10/11/05ISR Number: 4801577-4Report Type:Expedited (15-DaCompany Report #S05-USA-04433-01 Age:94 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alanine Aminotransferase Health Namenda (Memantine) PS ORAL 10 MG BID PO Initial or Prolonged Increased Professional Risperdal Aspartate (Risperidone) SS ORAL 0.5 MG BID PO Aminotransferase Flomax C Increased Aspirin C Atrioventricular Block Alphagan First Degree (Brimonidine Blood Alkaline Tartrate) C Phosphatase Increased Blood Bilirubin Increased Blood Glucose Increased Bundle Branch Block Left Cholelithiasis Dyskinesia Gait Disturbance Hepatic Enzyme Increased Nitrite Urine Present Parkinson'S Disease Somnolence Tremor Urinary Tract Infection 22-Feb-2006 08:20 AM Page: 2691 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/11/05ISR Number: 4804122-2Report Type:Direct Company Report #CTU 260866 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperdal 3mg PS 2 TIMES A DAY Dyskinesia Metabolic Disorder Muscle Spasms Muscle Twitching Date:10/12/05ISR Number: 4795333-3Report Type:Expedited (15-DaCompany Report #ES-GLAXOSMITHKLINE-B0396900A Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Augmentin Iv PS Glaxosmithkline INTRAVENOUS 3G Per day 7 DAY Hospitalization - Dysphagia Baycip SS ORAL 1G Per day 11 DAY Initial or Prolonged Pneumonia Aremis SS ORAL 50MG Per day Sinogan SS ORAL 50MG Per day Rivotril SS ORAL 2MG Per day Risperdal SS ORAL 3MG Per day Date:10/12/05ISR Number: 4795481-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051001244 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Risperdal PS ORAL Initial or Prolonged Fall Risperdal SS ORAL Inadequate Diet Risperdal SS ORAL Neuroleptic Malignant Quetiapine Fumarate SS ORAL Syndrome Quetiapine Fumarate SS ORAL Open Wound Risperdal SS ORAL Etizolam C ORAL Flunitrazepam C ORAL Triazolam C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Date:10/12/05ISR Number: 4795482-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20051001315 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pruritus Risperdal PS ORAL Serotonin Syndrome Risperdal SS ORAL Lamictal C ORAL Lamictal C ORAL Wellbutrin Sr C Wellbutrin Sr C Neurontin C Neurontin C Escitalopram Oxalate C ORAL Escitalopram Oxalate C ORAL 22-Feb-2006 08:20 AM Page: 2692 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/12/05ISR Number: 4795483-1Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20051001567 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Risperdal PS ("for a few years") Date:10/12/05ISR Number: 4796018-XReport Type:Expedited (15-DaCompany Report #ES-MERCK-0510ESP00012 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Disorder Hyzaar PS Merck & Co., Inc ORAL Risperdal SS ORAL Paroxetine Hydrochloride SS ORAL Zocor SS ORAL Date:10/13/05ISR Number: 4796500-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051000377 Age:51 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pruritus Risperdal PS ORAL 22 DAY Initial or Prolonged Rash Erythematous Tegretol SS UNKNOWN 29 DAY Toxic Skin Eruption Atarax C UNKNOWN Imovane C UNKNOWN Levothyrox C UNKNOWN Noctamide C UNKNOWN Date:10/13/05ISR Number: 4796501-7Report Type:Expedited (15-DaCompany Report #AT-JNJFOC-20051000429 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypochromic Anaemia Risperdal PS UNKNOWN half dose in Initial or Prolonged the morning/half dose in the evening. Risperdal SS UNKNOWN half dose in the morning/half dose in the evening. Risperdal SS UNKNOWN half dose in the morning/half dose in the evening. Date:10/13/05ISR Number: 4796502-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051000928 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coma Risperdal Consta PS INTRAMUSCULAR Convulsion Tricyclic Diarrhoea Antidepressant Drugs SS Suicide Attempt Tachycardia 22-Feb-2006 08:20 AM Page: 2693 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/05ISR Number: 4796503-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050901959 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Acidosis Risperdal PS ORAL Completed Suicide Olanzapine SS ORAL Haemodialysis Fluoxetine SS ORAL Haemorrhagic Diathesis Zolpidem SS ORAL Hepatic Necrosis Hypotension Intentional Misuse Multiple Drug Overdose Date:10/13/05ISR Number: 4796936-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051001150 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal Consta PS INTRAMUSCULAR Date:10/13/05ISR Number: 4796937-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050901957 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Neuroleptic Malignant Risperidone PS Syndrome Ventricular Fibrillation Date:10/13/05ISR Number: 4796938-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051000312 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Shock Risperdal PS ORAL Initial or Prolonged Stevens-Johnson Syndrome Risperdal SS ORAL Other Allopurinol SS ORAL Perospirone Hydrochloride Hydrate C ORAL Perospirone Hydrochloride Hydrate C ORAL Perphenazine Maleate C ORAL Perphenazine Maleate C ORAL Date:10/13/05ISR Number: 4799680-0Report Type:Expedited (15-DaCompany Report #2005134380 Age:47 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Ziprasidone Initial or Prolonged Extrapyramidal Disorder Health ((Ziprasidone) PS ORAL 160 MG 80 MG, Other Hypotension Professional 2 1 D), ORAL Quadriparesis Other Risperidone (Risperidone) SS Biperiden (Biperiden) C Diazepam (Diazepam) C Valproate Sodium (Valproate Sodium) C 22-Feb-2006 08:20 AM Page: 2694 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/13/05ISR Number: 4799962-2Report Type:Expedited (15-DaCompany Report #200513421GDS Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Baycip Hospitalization - Pneumonia Aspiration Health (Ciprofloxacin Initial or Prolonged Professional Hydrochloride) PS ORAL 1000 MG, Other TOTAL DAILY, ORAL Augmentin SS INTRAVENOUS 3000 MG, TOTAL DAILY, INTRAVENOUS Aremis (Sertraline Hydrochloride) SS ORAL 50 MG, TOTAL DAILY, ORAL Sinogan (Levomepromazine) SS ORAL 50 MG, TOTAL DAILY, ORAL Rivotril (Clonazepam) SS ORAL 2 MG, TOTAL DAILY, ORAL Risperdal (Risperidone) SS ORAL 3 MG, TOTAL DAILY, ORAL Date:10/13/05ISR Number: 4800065-9Report Type:Expedited (15-DaCompany Report #2005137377 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abnormal Behaviour Foreign Atarax (Tablet) Initial or Prolonged Fall Health (Hydroxyzine Folate Deficiency Professional Hydrochloride) PS ORAL 50 MG (1 IN 1 Hand Fracture D), ORAL Normochromic Normocytic Aldalix Anaemia (Spironolactone, Pancytopenia Furosemide) SS ORAL (1 IN 1 D), Tremor ORAL Risperdal (Risperidone) SS ORAL ORAL Daflon (Diosmin) SS ORAL (500 MG), ORAL Primidone (Primidone) SS ORAL (250 MG, 3 IN 1 D), ORAL Di-Antalvic (Dextropropoxyphene Hydrochloride, Paracetamol) SS ORAL ORAL Detensiel (Bisoprolol) C Date:10/14/05ISR Number: 4798686-5Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20051000415 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal PS ORAL Dose: 0.25-0.5 mg Risperdal SS ORAL Reminyl C ORAL 1021 DAY Reminyl C ORAL 1021 DAY 22-Feb-2006 08:20 AM Page: 2695 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Reminyl C ORAL 1021 DAY Date:10/14/05ISR Number: 4798687-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051001295 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Interstitial Lung Disease Risperdal PS ORAL Disability Sertraline SS ORAL Sertraline SS ORAL 50-100 mg Date:10/14/05ISR Number: 4798688-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041206151 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Risperdal PS ORAL (3 mg tablet; Initial or Prolonged Insulin-Dependent 1.5 tablets Other Diabetic Ketoacidosis daily) Risperdal SS ORAL Risperdal SS ORAL Risperdal SS ORAL (1 mg tablet; one-half tablet twice daily) Risperdal SS ORAL Luvox C ORAL (100 mg tablet; one tablet in morning and 0.5 tablet at Paxil C ORAL (started at 10 mg in approximately Nov-97) Paxil C ORAL (20 mg tablet; 3 tablets every morning) Klonopin C ORAL (1.5 pills twice daily) Klonopin C ORAL (1 mg tablet; 1.5 tablets twice daily) Date:10/14/05ISR Number: 4798689-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051001596 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombocytopenia Risperdal PS ORAL Risperdal SS ORAL Date:10/14/05ISR Number: 4798690-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051001608 Age: Gender:Male I/FU:I Outcome PT Death Cerebral Haemorrhage Cerebrovascular Accident Ruptured Cerebral 22-Feb-2006 08:20 AM Page: 2696 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aneurysm Report Source Product Role Manufacturer Route Dose Duration Risperdal Consta PS INTRAMUSCULAR Date:10/14/05ISR Number: 4798691-9Report Type:Periodic Company Report #US-JNJFOC-20050904417 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Risperidone PS ORAL Initial or Prolonged Asthenia Floxyfral C Psychotic Disorder Alprazolam C Vomiting Date:10/14/05ISR Number: 4798692-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051000632 Age:19 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Risperdal PS ORAL Convulsion Risperdal SS ORAL Cyanosis Foaming At Mouth Date:10/14/05ISR Number: 4798693-2Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050705215 Age:55 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Breast Cancer Stage Iii Risperdal PS ORAL Other Oestrogen Receptor Assay Risperdal SS ORAL Positive Progesterone Receptor Assay Positive Date:10/14/05ISR Number: 4798984-5Report Type:Expedited (15-DaCompany Report #JP-ABBOTT-05P-087-0313416-00 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Patent Ductus Arteriosus Biperiden PS Pneumothorax Estazolam SS Haloperidol SS Fluphenazine Enanthate SS Risperidone SS Chlorpromazine Hibenzate SS Brotizolam SS Nitrazepam SS Date:10/14/05ISR Number: 4803613-8Report Type:Expedited (15-DaCompany Report #2005139485 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Insomnia Foreign Sertraline Disability Interstitial Lung Disease Health (Sertraline) PS ORAL ORAL Professional Risperidone (Risperidone) SS ORAL (6 MG), ORAL 22-Feb-2006 08:20 AM Page: 2697 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/14/05ISR Number: 4804048-4Report Type:Expedited (15-DaCompany Report #2004032509 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cheilitis Consumer Zoloft (Sertraline) PS ORAL 100 MG (100 Chest Pain MG, 1 IN 1 Condition Aggravated D), ORAL Cough Geodon (Ziprasidone) SS 80 MG (80 MG, Diarrhoea 1 IN 1 D), Dizziness Dexamfetamine Drug Interaction (Dexamfetamine) SS Feeling Drunk Abilify Formication (Aripiprazole) SS Hypertension Risperdal Hypothyroidism (Risperidone) SS Nausea Clonazepam Obsessive-Compulsive (Clonazepam) C Disorder Levoxyl Palpitations (Levothyroxine Panic Attack Sodium) C Paranoia Multivitamins Rash (Multivitamins) C Restlessness Vitamin C (Vitamin Rhinorrhoea C) C Serotonin Syndrome Calcium (Calcium) C Somnolence Vitamin B Complex Tunnel Vision (Calcium Vertigo Pantothenate, Vomiting Nicotinamide, Weight Increased Pyridoxine C Hydroxyzine (Hydroxyzine) C Benadryl C Date:10/14/05ISR Number: 4804050-2Report Type:Expedited (15-DaCompany Report #2005138272 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Consumer Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, Initial or Prolonged Increased 1 IN 1 D), Disability Condition Aggravated ORAL Other Diarrhoea Navane (Capsules) Drug Ineffective (Thiothixene) SS ORAL ORAL Eating Disorder Valproic Acid Gastrooesophageal Reflux (Valproic Acid) SS Disease Risperdal Insomnia (Risperidone) SS Loss Of Employment All Other Sleep Apnoea Syndrome Therapeutic Products Therapeutic Response (All Other Unexpected With Drug Therapeutic Substitution Products) SS Tremor All Other Therapeutic Products (All Other Therapeutic Products) SS Insulin (Insulin) C Anti-Diabetics (Anti-Diabetics) C Metformin 22-Feb-2006 08:20 AM Page: 2698 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Metformin) C Citalopram (Citalopram) C Date:10/17/05ISR Number: 4800167-7Report Type:Periodic Company Report #GB-JNJFOC-20050904078 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - No Adverse Drug Effect Risperdal Consta PS UNKNOWN Initial or Prolonged Other Date:10/17/05ISR Number: 4800168-9Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20051001319 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Liver Disorder Risperdal PS ORAL Risperdal Consta SS INTRAMUSCULAR Date:10/17/05ISR Number: 4800169-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050902743 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Overdose Risperdal PS ORAL Collapse Of Lung Risperdal SS ORAL Death Loss Of Consciousness Pneumonia Staphylococcal Wrong Drug Administered Date:10/17/05ISR Number: 4800170-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051001993 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperprolactinaemia Risperdal Consta PS INTRAMUSCULAR Pituitary Tumour Benign Date:10/17/05ISR Number: 4800171-9Report Type:Expedited (15-DaCompany Report #SK-JNJFOC-20051000947 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Death Risperidone PS INTRAMUSCULAR Risperidone SS ORAL 14 DAY Date:10/17/05ISR Number: 4804859-5Report Type:Expedited (15-DaCompany Report #12650 Age:57 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Enalapril PS Other Drug Toxicity Health Doxepin SS Multiple Drug Overdose Professional Risperidone SS 22-Feb-2006 08:20 AM Page: 2699 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/18/05ISR Number: 4801408-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051001573 Age:75 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Risperdal PS ORAL Patient took Psychotic Disorder abusively a half tablet of risperidone Date:10/18/05ISR Number: 4801761-XReport Type:Expedited (15-DaCompany Report #DK-JNJFOC-20050906511 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Convulsion Risperdal Consta PS INTRAMUSCULAR Sudden Death Risperdal SS ORAL Orap C ORAL Seroquel C Disipal C Pantoloc C Novynette C Novynette C Rivotril C Gaviscon C Gaviscon C Mixt 15 ml p.n. max. x 3 Oxazepam C 15 mg p.n.max. x 4 Primperam C 20 mg p.n. max. 2 Pinex C 1 g p.n. max.x 3 Truxal C 50-100 mg p.n. max 250mg Lactulose C Date:10/18/05ISR Number: 4804515-3Report Type:Direct Company Report #CTU 260804 Age:67 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drooling Lithium 300mg PS ORAL 4 CAPSULES HS Initial or Prolonged Fluid Intake Reduced PO Gait Disturbance Risperidal 2mg SS ORAL 2MG HS PO Tremor Date:10/19/05ISR Number: 4803376-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051001593 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Risperdal PS ORAL 173 DAY Initial or Prolonged Pyrexia Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Lepticur C Nozinan C 22-Feb-2006 08:20 AM Page: 2700 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seresta C Date:10/19/05ISR Number: 4803377-8Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20051001651 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphagia Risperdal PS ORAL Oropharyngeal Spasm Risperdal SS ORAL Tremor Risperdal SS ORAL Risperdal SS ORAL Lithlofor C ORAL Sortis C ORAL Trazodone C ORAL Cipralex C ORAL Date:10/19/05ISR Number: 4803379-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050400398 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Risperdal PS ORAL 415 DAY Initial or Prolonged Blood Creatine Mepronizine C Phosphokinase Increased Mepronizine C Coma Rivotril C Disorientation Vivalan C Ecchymosis Akineton C Fall Zestril C Hyponatraemia Previscan C Inappropriate Temesta C Antidiuretic Hormone Loxen C Secretion Tenormine C Prothrombin Time Prolonged Tremor Water Intoxication Date:10/19/05ISR Number: 4803380-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051002013 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Impulsive Behaviour Risperdal PS ORAL 160mg total Initial or Prolonged Overdose Somnolence Date:10/19/05ISR Number: 4803381-XReport Type:Expedited (15-DaCompany Report #CA-JNJFOC-20050800273 Age:83 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Confusional State Risperdal PS UNKNOWN Hallucination Heart Medications C UNKNOWN Lung Disorder Antihypertensives C UNKNOWN 22-Feb-2006 08:20 AM Page: 2701 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/05ISR Number: 4803382-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051003019 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Risperdal PS ORAL Initial or Prolonged Decreased Appetite Weight Increased Date:10/19/05ISR Number: 4803383-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051003023 Age:44 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Risperdal PS Death Haldol SS Lithium C Antilirium C Date:10/19/05ISR Number: 4803384-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051001244 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Risperdal PS ORAL Initial or Prolonged Dehydration Risperdal SS ORAL Fall Risperdal SS ORAL Inadequate Diet Quetiapine Fumarate SS ORAL Neuroleptic Malignant Quetiapine Fumarate SS ORAL Syndrome Risperdal SS ORAL Open Wound Etizolam C ORAL Pneumonia Flunitrazepam C ORAL Triazolam C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Date:10/19/05ISR Number: 4803385-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051000632 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Risperdal PS ORAL Convulsion Risperdal SS ORAL Cyanosis Fatigue Foaming At Mouth Date:10/19/05ISR Number: 4803386-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050801371 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rectal Prolapse Risperidone PS ORAL Initial or Prolonged Risperidone SS ORAL Risperidone SS ORAL Lithium Carbonate C ORAL Sennoside C ORAL Sennoside C ORAL Sennoside C ORAL Flunitrazepam C ORAL 22-Feb-2006 08:20 AM Page: 2702 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/05ISR Number: 4803387-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050100908 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anaemia Risperdal PS ORAL Initial or Prolonged Blood Cholinesterase Risperdal SS ORAL Other Decreased Risperdal SS ORAL Dysphagia Risperdal SS ORAL Extrapyramidal Disorder Risperdal SS ORAL Hypercholesterolaemia Biperiden Hypokalaemia Hydrochloride C ORAL Hypoproteinaemia Flunitrazepam C ORAL Malnutrition Lorazepam C ORAL Pneumonia Aspiration Mosapride Citrate C ORAL Weight Decreased White Blood Cell Count Increased Date:10/19/05ISR Number: 4803389-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051003234 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akinesia Risperdal Consta PS INTRAMUSCULAR Blood Creatine Tercian C ORAL Phosphokinase Increased Hyperhidrosis Myalgia Date:10/19/05ISR Number: 4803390-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041206151 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Catheter Site Haemorrhage Risperdal PS ORAL Initial or Prolonged Diabetes Mellitus Risperdal SS ORAL Other Insulin-Dependent Risperdal SS ORAL Diabetic Ketoacidosis Risperdal SS ORAL (1 mg tablet; Dysphonia one-half Educational Problem tablet twice Mental Status Changes daily) Muscle Rigidity Risperdal SS ORAL Risperdal SS ORAL (3 mg tablet; 1.5 tablets daily) Luvox C ORAL (100 mg tablet; one tablet in morning and 0.5 tablet at Paxil C ORAL (started at 10 mg in approximately Nov-97) Paxil C ORAL (20 mg tablet; 3 tablets every morning) Paxil C ORAL Klonopin C ORAL (1.5 pills twice daily) Klonopin C ORAL (1 mg tablet; 22-Feb-2006 08:20 AM Page: 2703 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1.5 tablets twice daily) Date:10/19/05ISR Number: 4803392-4Report Type:Expedited (15-DaCompany Report #KR-JNJFOC-20050703279 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pneumonia Aspiration Reminyl PS ORAL 183 DAY Respiratory Distress Reminyl SS ORAL 183 DAY Stupor Risperidone SS ORAL 213 DAY Stilnox SS ORAL 14 DAY Risperidone SS ORAL 213 DAY Reminyl SS ORAL 183 DAY Plavix C ORAL 70 DAY Date:10/19/05ISR Number: 4806132-8Report Type:Direct Company Report #CTU 260949 Age:65 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Platelet Count Decreased Risperidone 1mg PS BUCCAL 1MG BID Initial or Prolonged BUCCAL Amitriptyline Hcl C Citalopram Hydrobromide C Finasteride C Furosemide C Gemfibrozil C Hydroxyzine Pamoate C Insulin -Novolin N- C Insulin Human Aspart C Insulin C Date:10/19/05ISR Number: 4806731-3Report Type:Expedited (15-DaCompany Report #FRWYE001623SEP05 Age:81 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abulia Foreign Effexor PS ORAL 2 DOSE 1X PER Initial or Prolonged Alanine Aminotransferase Health 1 DAY ORAL Increased Professional Lasilix (Furosemide) SS ORAL 20 MG 2X PER Aspartate Other 1 DAY ORAL 54 DAY Aminotransferase Reminyl Increased (Galantamine) SS ORAL 12 MG 2X PER Asthenia 1 DAY ORAL 98 DAY Blood Amylase Increased Risperdal Blood Bilirubin Increased (Risperidone) SS ORAL 0.5 MG 1X PER Blood Sodium Increased 1 DAY ORAL 98 DAY Condition Aggravated Ebixa (Memantine Dehydration Hydrochloride) C Fall Triatec (Ramipril) C Gamma-Glutamyltransferase Mopral (Omeprazole) C Increased Plavix (Clopidogrel General Physical Health Sulfate) C Deterioration Arcalion Liver Function Test (Bisbutiamine) C Abnormal Di-Antalvic Orthostatic Hypotension (Dextropoproxyphene Renal Failure Hydrochloride/Parace White Blood Cell Count tamol) C Increased 22-Feb-2006 08:20 AM Page: 2704 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/19/05ISR Number: 4807065-3Report Type:Expedited (15-DaCompany Report #2005-10-0286 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Disorder Foreign Nitro-Dur .4mg/Hr Hospitalization - Health System Initial or Prolonged Professional (Nitroglycerin) Other Transdermal PS TRANSDERMAL TRANSDERMAL Risperdal Coated Tablets SS ORAL 6 MG BID ORAL Artane Tablets SS ORAL 5 MG QD ORAL Valsartan Capsules SS ORAL 160 MG QD ORAL Date:10/20/05ISR Number: 4804140-4Report Type:Expedited (15-DaCompany Report #DE-BRISTOL-MYERS SQUIBB COMPANY-13138052 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Abilify PS Otsuka Pharmaceutical Company, Ltd. ORAL increased from 15 mg daily to 20 mg daily on 15-Jul-2005 Risperdal SS ORAL Cymbalta SS ORAL Diazepam C ORAL Amitriptyline C ORAL Date:10/20/05ISR Number: 4804721-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051002258 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Infection Risperdal PS ORAL Hospitalization - Intestinal Obstruction Risperdal SS ORAL Initial or Prolonged Leukopenia Septic Shock Date:10/20/05ISR Number: 4804722-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051002281 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperdal PS ORAL 332 DAY Initial or Prolonged Phosphokinase Increased Risperdal SS ORAL 332 DAY Drug Interaction Lepticur C UNKNOWN Rhabdomyolysis Mogadon C UNKNOWN Theralene C UNKNOWN Tercian I ORAL Tercian I ORAL Tercian I ORAL Date:10/20/05ISR Number: 4804723-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051002331 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Proteinuria Risperdal PS ORAL 22-Feb-2006 08:20 AM Page: 2705 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/05ISR Number: 4804725-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051002358 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Risperidone PS ORAL Venlafaxine SS ORAL Amitriptyline SS UNKNOWN 75 mg NOCTE Date:10/20/05ISR Number: 4804726-7Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20051001567 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Risperdal PS ORAL ("for a few years") Date:10/20/05ISR Number: 4804727-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051002555 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Risperdal PS ORAL Initial or Prolonged Dysphagia Alcohol SS Extrapyramidal Disorder Gait Disturbance Hand Deformity Swollen Tongue Trismus Date:10/20/05ISR Number: 4804728-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051002576 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breath Odour Risperdal PS ORAL 4x4mg tablets Overdose Alcohol SS ORAL Somnolence Truxal SS ORAL Suicide Attempt Tachycardia Date:10/20/05ISR Number: 4804729-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051002681 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Risperdal PS UNKNOWN 3.5x3mg Restlessness tablets Tachycardia Date:10/20/05ISR Number: 4804730-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051002837 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Risperdal PS ORAL 6 mg at night 22-Feb-2006 08:20 AM Page: 2706 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/05ISR Number: 4804731-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051002840 Age:18 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Risperdal PS RESPIRATORY Vomiting (INHALATION) inhaled 1 tablet Alcohol SS UNKNOWN Date:10/20/05ISR Number: 4804732-2Report Type:Expedited (15-DaCompany Report #NZ-JNJFOC-20051003378 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutrophil Count Risperdal PS ORAL (dose was Decreased reduced from Sedation 4 mg to 3 mg during the week prior to Risperdal SS ORAL (dose was reduced from 4 mg to 3 mg during the week prior to Valproate SS Fluoxetine C Date:10/20/05ISR Number: 4804733-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051004049 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Congenital Anomaly Risperidone PS TRANSPLACENTAL Venlafaxine SS TRANSPLACENTAL Amitriptyline SS TRANSPLACENTAL AT NOCTE Date:10/20/05ISR Number: 4807587-5Report Type:Expedited (15-DaCompany Report #8012483 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Literature Methylphenidate PS 15 MG 3/D Initial or Prolonged Musculoskeletal Stiffness Health Risperidone SS 1.5 MG 3/D Physical Assault Professional Date:10/20/05ISR Number: 4807622-4Report Type:Expedited (15-DaCompany Report #8012516 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Extrapyramidal Disorder Literature Methylphenidate PS 36 MG /D Initial or Prolonged Intentional Self-Injury Health Methylphenidate SS 54 MG /D Professional Fluvoxamine SS 150 MG 2/D Guanfacine SS 1 MG 2/D Risperidone SS 0.5 MG 3/D 22-Feb-2006 08:20 AM Page: 2707 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/05ISR Number: 4807818-1Report Type:Expedited (15-DaCompany Report #2005139478 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Aremis (Sertraline) PS ORAL 50 MG (100 Hospitalization - Drug Interaction Health MG, 1 IN 1 Initial or Prolonged Pneumonia Aspiration Professional D), ORAL Other Augmentine (Amoxicillin Sodium, Amoxicillin Trihydrate, Clavulanate SS INTRAVENOUS 3 GRAM/600 MG (3 IN 1 D), INTRAVENOUS Ciprofloxacin (Ciprofloxacin) SS ORAL 1 GRAM (500 MG, 2 IN 1 D), ORAL Sinogan (Levomepromazine) SS ORAL 50 MG (100 MG, 1 IN 1 D), ORAL Rivotril (Clonazepam) SS ORAL 2 MG (2 MG, 1 IN 1 D), ORAL Risperdal (Risperidone) SS ORAL 3 MG (3 MG, 1 IN 1 D), ORAL Date:10/21/05ISR Number: 4805811-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040909537 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperdal PS UNKNOWN 29 DAY Insulin-Dependent Pain Date:10/21/05ISR Number: 4805812-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050905835 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blepharospasm Risperdal PS ORAL reported as Cervical Spasm nocte Risperdal SS ORAL Date:10/21/05ISR Number: 4805813-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050801305 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Risperdal PS ORAL White Blood Cell Count Fosamax C ORAL Decreased Synthroid C ORAL Synthroid C ORAL Arimidex C ORAL Paxil C ORAL Temazepam C 22-Feb-2006 08:20 AM Page: 2708 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/05ISR Number: 4805814-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051003631 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Risperdal Consta PS INTRAMUSCULAR Dyspnoea Fibromyalgia Injection Site Pain Systemic Lupus Erythematosus Date:10/21/05ISR Number: 4805815-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050704362 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cholelithiasis Risperdal Consta PS INTRAMUSCULAR Heat Stroke Risperdal Consta SS INTRAMUSCULAR Lexapro C Trileptal C Date:10/21/05ISR Number: 4805816-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050604252 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Ascites Risperdal PS ORAL Hepatic Cirrhosis Leukopenia Platelet Count Decreased Date:10/21/05ISR Number: 4806334-0Report Type:Expedited (15-DaCompany Report #ES-ROCHE-420481 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Rivotril PS Roche ORAL Hospitalization - Pneumonia Baycip I ORAL 11 DAY Initial or Prolonged Urinary Tract Infection Augmentin I INTRAVENOUS 7 DAY Aremis I ORAL Sinogan I ORAL Risperdal I ORAL Date:10/21/05ISR Number: 4806463-1Report Type:Expedited (15-DaCompany Report #2005UW15687 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Seroquel PS Zeneca Disability Injury Pharmaceutical ORAL 22 MON Abilify SS 22 MON Risperdal SS 22 MON Date:10/21/05ISR Number: 4806797-0Report Type:Direct Company Report #USP 57361 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Medication Error Risperdal PS Janssen TABLET Risperdal SS Janssen TABLET 22-Feb-2006 08:20 AM Page: 2709 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/21/05ISR Number: 4808733-XReport Type:Direct Company Report #CTU 261176 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Trismus Risperdal 2mg PS ORAL 2MG HS PO 2 DAY Date:10/21/05ISR Number: 4809126-1Report Type:Expedited (15-DaCompany Report #A044-002-005750 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Asthenia Foreign Aricept (Donepezil Drug Interaction Health Hydrochloride) PS ORAL 5 MG, 1 IN 1 Muscle Spasms Professional D, ORAL Radial Nerve Palsy Fluoxetine Tremor (Fluoxetine) SS ORAL 20 MG, ORAL Risperidone (Risperidone) SS ORAL 0.5 MG, ORAL Rivastigmine (Rivastigmine) C Date:10/24/05ISR Number: 4807464-XReport Type:Expedited (15-DaCompany Report #CH-JNJFOC-20051003184 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drop Attacks Risperdal PS ORAL Initial or Prolonged Hypotension Risperdal SS ORAL Temesta C ORAL Temesta C ORAL Temesta C ORAL Temesta C ORAL Temesta C ORAL Spasmo-Urgenin C Spasmo-Urgenin C Spasmo-Urgenin C Aspirin Protect C ORAL Dipiperon C ORAL Date:10/24/05ISR Number: 4810046-7Report Type:Expedited (15-DaCompany Report #2005143131 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Foreign Atarax (Tablet) Initial or Prolonged Multiple Drug Overdose Health (Hydroxyzine Suicide Attempt Professional Hydrochloride) PS ORAL 2500 MG (ONE Tachycardia TIME INGESTION), ORAL Zoloft (Sertraline) SS ORAL 20 TABLETS (ONE TIME INGESTION), ORAL Risperdal (Risperidone) SS ORAL 20 MG (ONE TIME INGESTION), ORAL Alcohol (Ethanol) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 2710 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/24/05ISR Number: 4810119-9Report Type:Expedited (15-DaCompany Report #2005143131 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Drug Overdose Foreign Atarax (Tablet) Initial or Prolonged Intentional Health (Hydroxyzine Suicide Attempt Professional Hydrochloride) PS ORAL 2500 MG (ONE Tachycardia TIME INGESTION), ORAL Zoloft (Sertraline) SS ORAL 20 TABLETS (ONE TIME INGESTION), ORAL Risperdal (Risperidone) SS ORAL 20 MG (ONE TIME INGESTION), ORAL Alcohol (Ethanol) SS ORAL ORAL Date:10/24/05ISR Number: 4810766-4Report Type:Expedited (15-DaCompany Report #USA-2005-0021546 Age:53 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Literature Oxycodone Health Hydrochloride Professional (Similar To Nda 20-533)(Oxycodone Hydrochloride) PS ORAL SEE TEXT, ORAL Risperidone (Risperidone) SS ORAL SEE TEXT, ORAL Mirtazapine (Mirtazapine) SS ORAL SEE TEXT, ORAL Date:10/25/05ISR Number: 4808561-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050906924 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Lithium PS Glaxosmithkline UNKNOWN Renal Failure Chronic Risperdal SS UNKNOWN Date:10/25/05ISR Number: 4808866-8Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20051003090 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal PS ORAL Breast Cancer Risperdal SS (recently Drug Exposure During switched back Pregnancy to oral) Menstruation Irregular 22-Feb-2006 08:20 AM Page: 2711 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/05ISR Number: 4808867-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051003117 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Risperdal Consta PS INTRAMUSCULAR Radius Fracture Date:10/25/05ISR Number: 4808868-1Report Type:Periodic Company Report #FR-JNJFOC-20050905518 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Amylase Increased Risperdal PS ORAL 99 DAY Initial or Prolonged Cytolytic Hepatitis Reminyl C ORAL 99 DAY Dehydration Ebixa C UNKNOWN Drug Interaction Triatec C UNKNOWN General Physical Plavix C UNKNOWN for several Condition years Orthostatic Hypotension Arcalion C UNKNOWN Renal Failure Diantalvic C UNKNOWN Diantalvic C UNKNOWN Corvasal C UNKNOWN for several years Mopral C UNKNOWN for several years Lasilix I ORAL 55 DAY Effexor I ORAL 2 cp per day 55 DAY Date:10/25/05ISR Number: 4808870-XReport Type:Expedited (15-DaCompany Report #ES-JNJFOC-20051003399 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Risperdal PS ORAL Hospitalization - Pneumonia Baycip SS ORAL reported as Initial or Prolonged Pneumonia Aspiration 1g/d2 Augmentine SS INTRAVENOUS Augmentine SS INTRAVENOUS Aremis SS ORAL Sinogan SS ORAL Rivotril SS ORAL Date:10/25/05ISR Number: 4808871-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051001295 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Interstitial Lung Disease Risperdal PS ORAL Disability Sertraline SS ORAL Sertraline SS ORAL 50-100 mg Date:10/25/05ISR Number: 4808872-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051003885 Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Bilirubin Increased Risperdal PS Off Label Use 22-Feb-2006 08:20 AM Page: 2712 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/05ISR Number: 4808873-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050904628 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Renal Failure Acute Risperdal PS ORAL Hospitalization - Rhabdomyolysis Risperdal SS ORAL Initial or Prolonged Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Olanzapine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Biperiden Hydrochloride C Biperiden Hydrochloride C Biperiden Hydrochloride C Diazepam C Diazepam C Nitrazepam C Clonazapine C Clonazapine C Zopiclone C Lorazepam C Loxoprofen Sodium C Loxoprofen Sodium C Rebamipide C Rebamipide C Date:10/25/05ISR Number: 4808875-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051004309 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pancytopenia Risperdal PS ORAL Date:10/25/05ISR Number: 4808876-0Report Type:Expedited (15-DaCompany Report #SK-JNJFOC-20051000947 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Death Risperidone PS INTRAMUSCULAR Risperidone SS ORAL 14 DAY 22-Feb-2006 08:20 AM Page: 2713 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/05ISR Number: 4808877-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051002258 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cholecystitis Risperdal PS ORAL Hospitalization - Infection Risperdal SS ORAL Initial or Prolonged Intestinal Obstruction Leukopenia Septic Shock Date:10/26/05ISR Number: 4809896-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050103391 Age:60 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pericardial Effusion Risperdal PS nocte Benzafibrate C Lithium C Paroxetine C Metformin C Glicazide C Ranitidine C Enalapril C Amlodopine C Date:10/26/05ISR Number: 4809897-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051004314 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypokalaemia Risperdal PS ORAL Initial or Prolonged Pancytopenia Risperdal SS ORAL Risperdal SS ORAL Promethazine Hydrochloride C ORAL Chlorpromazine Hibenzate C ORAL Mazaticol Hydrochloride C ORAL Date:10/26/05ISR Number: 4809898-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051000312 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Shock Risperdal PS ORAL Initial or Prolonged Stevens-Johnson Syndrome Risperdal SS ORAL Other Allopurinol SS ORAL Perospirone Hydrochloride Hydrate C ORAL Perospirone Hydrochloride Hydrate C ORAL Perphenazine Maleate C ORAL Perphenazine Maleate C ORAL 22-Feb-2006 08:20 AM Page: 2714 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/26/05ISR Number: 4810330-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051004240 Age:9 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Dystonia Risperdal PS Respiratory Arrest Wellbutrin C Date:10/26/05ISR Number: 4810331-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051004394 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Risperdal PS ORAL Initial or Prolonged First Degree Risperdal SS ORAL Bundle Branch Block Left Namenda SS ORAL Cholelithiasis Flomax C Gait Disturbance Aspirin C Hepatic Enzyme Increased Alphagan C Parkinsonism Somnolence Tremor Urinary Tract Infection Date:10/26/05ISR Number: 4811369-8Report Type:Direct Company Report #CTU 261514 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperidone 30 Mg Daily PS ORAL 30 MG PO QD Date:10/26/05ISR Number: 4811430-8Report Type:Direct Company Report #CTU 261547 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Risperidone PS ORAL PO Initial or Prolonged Syndrome Nefazodone Hcl C Date:10/26/05ISR Number: 4811811-2Report Type:Expedited (15-DaCompany Report #2005134380 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Ziprasidone (Caps) Initial or Prolonged Extrapyramidal Disorder Consumer (Ziprasidone) PS ORAL 160 MG (80 Other Hypotension Health MG, 2 IN 1 Quadriparesis Professional D), ORAL Risperidone (Risperidone) SS Biperiden (Biperiden) C Diazepam (Diazepam) C Valproate Sodium (Valproate) C 22-Feb-2006 08:20 AM Page: 2715 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/05ISR Number: 4810908-0Report Type:Expedited (15-DaCompany Report #2005UW15686 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Diabetes Mellitus Seroquel PS Zeneca Injury Pharmaceutical ORAL 52 MON Pancreatitis Chronic Risperdal SS 52 MON Zyprexa SS 52 MON Date:10/27/05ISR Number: 4811043-8Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20050805280 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Precocious Puberty Risperdal PS ORAL Nocte Risperdal SS ORAL Risperdal SS ORAL Nocte Date:10/27/05ISR Number: 4811044-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051004419 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cerebral Atrophy Risperdal PS ORAL Date:10/27/05ISR Number: 4811045-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051004621 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Visual Risperdal PS ORAL Initial or Prolonged Namenda C ORAL Aricept C ORAL Atenolol C ORAL Lanoxin C ORAL Colchicine C ORAL Cardura C ORAL Ktab C ORAL Coumadin C ORAL (2.5 mg daily; every Thursday 5 mg) Coumadin C ORAL (2.5 mg daily; every Thursday 5 mg) Demadex C ORAL Date:10/27/05ISR Number: 4811046-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050300921 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Risperdal PS ORAL Initial or Prolonged Breast Cancer Recurrent Risperdal SS ORAL Dysphagia Risperdal SS ORAL Pneumonia Aspiration Haldol Decanoate C INTRAVENOUS 9 DAY Furosemide C ORAL 22-Feb-2006 08:20 AM Page: 2716 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/27/05ISR Number: 4811191-2Report Type:Expedited (15-DaCompany Report #AT-JNJFOC-20051003785 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coma Risperdal PS UNKNOWN Hepatic Encephalopathy Risperdal SS UNKNOWN Dominal Forte C 41 DAY Ivadal C 41 DAY Nexium C 49 DAY Alna C 47 DAY Ebixa C Acecomb Tablets C UNKNOWN Date:10/27/05ISR Number: 4811192-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041106871 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haematocrit Decreased Risperdal PS ORAL Haemoglobin Decreased Risperdal SS ORAL Hyperglycaemia Risperdal SS ORAL Red Blood Cell Count Oren-Gedoku-To C ORAL Decreased Oren-Gedoku-To C ORAL White Blood Cell Count Oren-Gedoku-To C ORAL Decreased Estazolam C ORAL Flurazepam Hydrochloride C ORAL Promethazine Hydrochloride C ORAL Trihexyphenidyl Hydrochloride C ORAL Ecabet Sodium C ORAL Rilmazafone Hydrochloride C ORAL Date:10/27/05ISR Number: 4811486-2Report Type:Expedited (15-DaCompany Report #PHBS2005ES15699 Age:78 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cerebrovascular Disorder Kalpress PS Novartis Sector: Hospitalization - Pharma ORAL 160 mg, QD Initial or Prolonged Risperdal SS ORAL 6 mg, QD Artane SS ORAL 5 mg, QD Nitro-Dur SS TRANSDERMAL 80 mg, QD Date:10/27/05ISR Number: 4815623-5Report Type:Expedited (15-DaCompany Report #2005139485 Age:34 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Insomnia Foreign Sertraline Disability Interstitial Lung Disease Health (Sertraline) PS ORAL ORAL Professional Risperidone (Risperidone) SS ORAL (6 MG), ORAL 22-Feb-2006 08:20 AM Page: 2717 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/28/05ISR Number: 4811763-5Report Type:Expedited (15-DaCompany Report #JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BAge: 47NB Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Spiriva PS B.I. Pharmaceuticals,Inc. /Ridgefield RESPIRATORY (INHALATION) Risperidone SS ORAL Prednisolone SS ORAL Sennoside C ORAL Quetiapine Fumarate C ORAL Bromhexine Hydrochloride C ORAL Tulobuterol C TRANSDERMAL Date:10/28/05ISR Number: 4814924-4Report Type:Expedited (15-DaCompany Report #PHNU2005DE02376 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bundle Branch Block Left Leponex / Clozaril Initial or Prolonged Cardiac Disorder (Clozapine) PS Novartis Sector: Drug Interaction Pharma ORAL up to 500 mg, Drug Level QD Rhabdomyolysis Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 625 mg, QD Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL 550 mg, QD 4320 MIN Risperdal SS ORAL 4 mg, QD Orfiril C ORAL 1500 mg, QD Resonium A C ORAL 45 g, QD Date:10/28/05ISR Number: 4814968-2Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20051004579 Age:22 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Risperdal PS ORAL Cardiac Arrest Haldol C Death Topimax C Epilepsy Lamictal C Neurontin C Akineton C 2mg tablet Mallorol C Depo Provera C Stesolid C Date:10/28/05ISR Number: 4814969-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050802971 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Cellulitis Other Leukopenia Platelet Count Decreased Thrombocytopenia Urinary Tract Infection Vomiting 22-Feb-2006 08:20 AM Page: 2718 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Decreased Report Source Product Role Manufacturer Route Dose Duration Risperdal PS ORAL Risperdal SS ORAL Flunitrazepam SS ORAL Powdered Rhubarb SS ORAL Flunitrazepam SS ORAL Risperdal SS ORAL Alprazolam C ORAL Diazepam C Date:10/28/05ISR Number: 4814970-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051001244 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Risperdal PS ORAL Initial or Prolonged Dehydration Risperdal SS ORAL Fall Risperdal SS ORAL Inadequate Diet Quetiapine Fumarate SS ORAL Neuroleptic Malignant Quetiapine Fumarate SS ORAL Syndrome Risperdal SS ORAL Open Wound Etizolam C ORAL Pneumonia Flunitrazepam C ORAL Triazolam C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Date:10/28/05ISR Number: 4814971-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050904628 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Renal Failure Acute Risperdal PS ORAL Hospitalization - Rhabdomyolysis Risperdal SS ORAL Initial or Prolonged Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Olanzapine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Biperiden Hydrochloride C Biperiden 22-Feb-2006 08:20 AM Page: 2719 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride C Biperiden Hydrochloride C Diazepam C Diazepam C Nitrazepam C Clonazapine C Clonazapine C Zopiclone C Lorazepam C Loxoprofen Sodium C Loxoprofen Sodium C Rebamipide C Rebamipide C Date:10/28/05ISR Number: 4814972-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050500058 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperdal PS ORAL Initial or Prolonged Delusion Risperdal Consta SS INTRAMUSCULAR Dystonia Risperdal Consta SS INTRAMUSCULAR Musculoskeletal Stiffness Paranoia Date:10/28/05ISR Number: 4815472-8Report Type:Direct Company Report #CTU 261721 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Feeling Abnormal Benzotropine 1 Mg Life-Threatening Insomnia Tablets PS Hospitalization - Nervousness Risperdal 4 Mg Initial or Prolonged Nightmare Tablets SS Disability Rash Other Salivary Hypersecretion Date:10/28/05ISR Number: 4816470-0Report Type:Expedited (15-DaCompany Report #2005139478 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Aremis (Sertraline) PS ORAL 50 MG (100 Hospitalization - Drug Interaction MG, 1 IN 1 Initial or Prolonged Pneumonia Aspiration D), ORAL Other Respiratory Disorder Sinogan Urinary Tract Infection (Levomepromazine) SS ORAL 50 MG (100 MG, 1 IN 1 D), ORAL Augmentine (Amoxicillin Sodium, Amoxicllin Trihydrate, Clavulanate SS INTRAVENOUS 3 GRAM/600 MG (3 IN 1 D), INTRAVENOUS Ciprofloxacin (Ciprofloxacin) SS ORAL 1 GRAM (500 MG, 2 IN 1 D), ORAL Rivotril 22-Feb-2006 08:20 AM Page: 2720 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonazepam) SS ORAL 2 MG (2 MG, 1 IN 1 D), ORAL Risperdal (Risperidone) SS ORAL 3 MG (3 MG, 1 IN 1 D), ORAL Date:10/31/05ISR Number: 4815886-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051004410 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal PS UNKNOWN Phosphokinase Mb Risperdal Consta SS INTRAMUSCULAR Increased Nausea Date:10/31/05ISR Number: 4815887-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050402219 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Risperdal Consta PS INTRAMUSCULAR 71 DAY Drug Exposure During Risperdal Consta SS INTRAMUSCULAR prior to Pregnancy enrollment in study (dose not specified) 71 DAY Risperidone C ORAL Insulin Actrapid C 3-5 injections a day Insulin Mixtard C Insulin Humalog C Insulin Lantus C Diamicron C Date:10/31/05ISR Number: 4815888-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051000728 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akinesia Risperdal PS ORAL Balance Disorder Risperdal SS ORAL Dyskinesia Teralithe C UNKNOWN Dysphonia Teralithe C UNKNOWN Gait Disturbance Tranxene C UNKNOWN Tremor Tranxene C UNKNOWN Date:10/31/05ISR Number: 4815889-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904439 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Affect Lability Initial or Prolonged Anxiety Asthenia Balance Disorder Confusional State Convulsion Crying Depression Disturbance In Attention 22-Feb-2006 08:20 AM Page: 2721 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dry Mouth Dyskinesia Dysphagia Report Source Product Role Manufacturer Route Dose Duration Eating Disorder Symptom Risperdal PS ORAL (Temporarily Fear "ran out" in Hallucination, Auditory Aug-1996) Homicidal Ideation Risperdal SS ORAL (restarted on Inadequate Diet an Insomnia unspecified Mood Swings date) Muscle Spasms Risperdal SS ORAL (decreased Musculoskeletal Stiffness dose, then Social Phobia discontinued) Somnolence Risperdal SS ORAL Tardive Dyskinesia Risperdal SS ORAL Tremor Risperdal SS ORAL (at bedtime x Vomiting 4 weeks) Risperdal SS ORAL (at bedtime) Effexor C Wellbutrin C Zoloft C (with lunch) Desyrel C Date:10/31/05ISR Number: 4815890-8Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20051005662 Age:100 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hallucination Risperdal PS Date:10/31/05ISR Number: 4818521-6Report Type:Expedited (15-DaCompany Report #2005143983 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Adverse Drug Reaction Consumer Zoloft (Sertraline) PS Amnesia Risperdal Drug Interaction (Risperidone) SS Injury Strattera Sexual Abuse (Atomoxetine Suicide Attempt Hydrochloride) SS Theft Date:10/31/05ISR Number: 4818529-0Report Type:Expedited (15-DaCompany Report #2005138272 Age:36 YR Gender:Female I/FU:F Outcome PT Hospitalization - Blood Cholesterol Initial or Prolonged Increased Disability Condition Aggravated Other Diarrhoea Drug Ineffective Gastrooesophageal Reflux Disease Hallucinations, Mixed Insomnia Oral Intake Reduced Paranoia Sleep Apnoea Syndrome Therapeutic Response 22-Feb-2006 08:20 AM Page: 2722 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Unexpected With Drug Substitution Tremor Report Source Product Role Manufacturer Route Dose Duration Consumer Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, 1 IN 1 D), ORAL Navane (Capsules) (Thiothixene) SS ORAL ORAL Depakote (Valproate Semisodium) SS Risperdal (Risperidone) SS All Other Therapeutic Products (All Other Therapeutic Products) SS All Other Therapeutic Products (All Other Therapeutic Products) SS Insulin (Insulin) C Anti-Diabetics (Anti-Diabetics) C Metformin (Metformin) C Citalopram (Citalopram) C Date:11/01/05ISR Number: 4816542-0Report Type:Expedited (15-DaCompany Report #PHBS2005JP10886 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mucosal Erosion Voltaren PS Novartis Sector: Initial or Prolonged Oculomucocutaneous Pharma RECTAL 12.5 mg/day Syndrome Allozym SS ORAL Pharyngolaryngeal Pain Risperdal SS ORAL UNK, UNK Pyrexia Rash Generalised Swelling Face Date:11/01/05ISR Number: 4816962-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB02271 Age:16 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Tegretol PS Novartis Sector: Other Blepharophimosis Pharma ORAL 600 mg, BID Congenital Clobazam SS ORAL 10 mg, BID Convulsion Risperidone SS ORAL 0.5 mg, BID Epilepsy Topiramate C ORAL 50mg/day 37440MIN Grand Mal Convulsion 22-Feb-2006 08:20 AM Page: 2723 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/01/05ISR Number: 4817209-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051004886 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Systemic Lupus Risperdal PS ORAL Erythematosus Flunitrazepam C ORAL Clonazepam C ORAL Date:11/01/05ISR Number: 4817210-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050606652 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akinesia Risperdal Consta PS INTRAMUSCULAR Cold Sweat Risperdal Consta SS INTRAMUSCULAR Drug Interaction Risperdal SS UNKNOWN Enuresis Risperdal SS UNKNOWN Extrapyramidal Disorder Risperdal SS UNKNOWN General Physical Health Risperdal SS UNKNOWN Deterioration Planum C UNKNOWN Haematemesis Pantozol I UNKNOWN Muscle Rigidity Date:11/01/05ISR Number: 4817211-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051005272 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Risperdal PS ORAL Hospitalization - Hypertension Risperdal SS ORAL Initial or Prolonged Multi-Organ Failure Tylenol Arthritis C Calcium D C Calcium D C Calcium D C Ativan C Niacin C ORAL Date:11/01/05ISR Number: 4817212-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051005708 Age:47 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Risperdal Consta PS INTRAMUSCULAR Neurodermatitis Date:11/01/05ISR Number: 4817213-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051005927 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Risperdal PS Other Neuroleptic Malignant Seroquel SS Syndrome Zyprexa SS Date:11/01/05ISR Number: 4818574-5Report Type:Expedited (15-DaCompany Report #S05-USA-04089-01 Age:84 YR Gender:Female I/FU:F Outcome PT Other Alanine Aminotransferase Increased Aspartate 22-Feb-2006 08:20 AM Page: 2724 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Bilirubin Conjugated Increased Report Source Product Role Manufacturer Route Dose Duration Blood Alkaline Health Namenda (Memantine) PS ORAL 10 MG BID PO Phosphatase Increased Professional Celebrex (Celecoxib) SS 200 MG QD Company Risperdal Representative (Risperidone) SS 0.25 MG QHS Date:11/01/05ISR Number: 4843475-6Report Type:Periodic Company Report #DSA_26585_2005 Age:36 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Intentional Misuse Health Ativan PS ORAL DF ONCE PO Professional Ativan SS ORAL 2 MG PRN PO Risperidone SS ORAL 6 MG Q DAY PO Risperidone SS ORAL 4 MG Q DAY PO Risperidone SS ORAL 2 MG Q DAY PO Cogentin C Date:11/02/05ISR Number: 4817951-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20030904433 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Hernia Risperdal PS ORAL Initial or Prolonged Asthma Risperdal SS ORAL Pain In Extremity Albuterol C RESPIRATORY Rheumatoid Arthritis (INHALATION) as needed Doxepin C UNKNOWN 1 in the morning and 2 at night Effexor-Xr C UNKNOWN Darvocet-N 100 C UNKNOWN Darvocet-N 100 C UNKNOWN as needed Date:11/02/05ISR Number: 4818027-4Report Type:Expedited (15-DaCompany Report #AU-BRISTOL-MYERS SQUIBB COMPANY-13154570 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Abilify PS Otsuka Pregnancy Pharmaceutical Company, Ltd. Risperidone SS Date:11/02/05ISR Number: 4819727-2Report Type:Direct Company Report #CTU 262219 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rash Risperdal Tablet PS Date:11/03/05ISR Number: 4819422-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050905870 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amenorrhoea Risperdal PS ORAL Hyperprolactinaemia Stilnox C 1 Dose = 1 Pituitary Tumour Benign Tablet 22-Feb-2006 08:20 AM Page: 2725 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lepticur C Date:11/03/05ISR Number: 4819423-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050606946 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Risperdal PS ORAL Initial or Prolonged Aminotransferase Leponex SS ORAL Other Increased Orfiril C ORAL Bundle Branch Block Left Resonium C ORAL Drug Interaction Leponex I ORAL Rhabdomyolysis Leponex I ORAL Date:11/03/05ISR Number: 4819424-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040909537 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperdal PS UNKNOWN 29 DAY Insulin-Dependent Pain Date:11/03/05ISR Number: 4819425-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051005732 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Orap PS ORAL Took a Hospitalization - Overdose package of Initial or Prolonged Suicide Attempt Orap Forte 4 mg Risperdal Consta SS INTRAMUSCULAR Date:11/03/05ISR Number: 4819426-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051001150 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal Consta PS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Seroquel C Haldol C Ativan C Lexapro C Date:11/03/05ISR Number: 4819427-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051006004 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dry Eye Risperdal PS ORAL (taken "for Haemorrhage Subcutaneous several Leukopenia years") Thrombocytopenia Risperdal SS ORAL Risperdal SS ORAL 22-Feb-2006 08:20 AM Page: 2726 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/03/05ISR Number: 4819428-0Report Type:Periodic Company Report #DE-JNJFOC-20051003766 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Psoriasis Risperdal PS Risperdal C Date:11/03/05ISR Number: 4819429-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051001608 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebral Haemorrhage Risperdal Consta PS INTRAMUSCULAR 492 DAY Date:11/03/05ISR Number: 4819430-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050606265 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Epilepsy Risperdal PS ORAL Life-Threatening Tegretol SS ORAL Clobazam SS ORAL Topiramate C ORAL 26 DAY Topiramate C ORAL 26 DAY Date:11/03/05ISR Number: 4819431-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051006026 Age:8 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Risperdal PS ORAL Initial or Prolonged Overdose Risperdal SS ORAL 10 drops Somnolence Date:11/03/05ISR Number: 4821878-3Report Type:Expedited (15-DaCompany Report #2005127153 Age:87 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Chronic Foreign Prednisolone Other Cardiomegaly Health (Prednisolone) PS ORAL 5 MG (5 MG, 1 Hallucination, Visual Professional IN 1 D), ORAL Sudden Death Tiotropium Bromide (Tiotropium Bromide) SS RESPIRATORY (INHALATION) INHALATION Risperdal (Risperidone) SS ORAL 0.5 MG (0.5 MG, 1 IN 1 D), ORAL Trandolapril (Trandolapril) C Sennosides (Sennoside A+B) C Misoprostol (Misoprostol) C Loxoprofen Socium (Loxoprofen Sodium) C Quetiapine Fumarate (Quetiapine Fumarate) C Bucillamine (Bucillamine) C 22-Feb-2006 08:20 AM Page: 2727 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zopiclone (Zopiclone) C Date:11/04/05ISR Number: 4820611-9Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0580124A Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Adverse Event Requip PS Glaxosmithkline ORAL Hospitalization - Intubation Risperdal SS 3 DAY Initial or Prolonged Medication Error No Concurrent Other Medication C Date:11/04/05ISR Number: 4820668-5Report Type:Expedited (15-DaCompany Report #AT-JNJFOC-20051004904 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Incomplete Risperdal PS ORAL given in Drug Exposure During weeks 0-7 of Pregnancy gestation. Risperdal SS ORAL given at 15 weeks gestation. Haldol C INTRAMUSCULAR Gewacalm C INTRAMUSCULAR 10-20 mg Gewacalm C INTRAMUSCULAR 10-20 mg Temesta C ORAL Mirtabene C ORAL Date:11/04/05ISR Number: 4820669-7Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051005433 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Risperdal PS Suicide Attempt Zyprexa SS Thrombocytopenia Date:11/04/05ISR Number: 4820670-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051005806 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Risperdal PS Initial or Prolonged Date:11/04/05ISR Number: 4820671-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051100002 Age:32 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Risperdal Consta PS INTRAMUSCULAR Hyperprolactinaemia Risperdal Consta SS INTRAMUSCULAR Nipple Neoplasm Risperdal Consta SS INTRAMUSCULAR 22-Feb-2006 08:20 AM Page: 2728 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/04/05ISR Number: 4820672-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051100022 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Hyperprolactinaemia Other Pituitary Tumour Benign Date:11/04/05ISR Number: 4820673-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051100115 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Risperdal PS Initial or Prolonged Paranoia Lantus SS SUBCUTANEOUS (taken "for a Sepsis couple of Somnolence weeks") Zoloft SS Baclofen C Diflucan C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Zinc C Omeprazole C Vitamin C C Lasix C Vancomycin C Maxaquin C Date:11/04/05ISR Number: 4820674-0Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20051100261 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Risperdal Consta PS Pregnancy Unspecified Gestational Diabetes Concomitant Medications C Date:11/04/05ISR Number: 4820818-0Report Type:Expedited (15-DaCompany Report #IN-JNJFOC-20051005812 Age:24 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Risperdal PS ORAL Initial or Prolonged Pregnancy Folic Acid C Other Oligohydramnios Calcium C Psychotic Disorder Iron Supplements C Date:11/04/05ISR Number: 4822382-9Report Type:Direct Company Report #CTU 262433 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperidone 3 Mg PS ORAL 3 MG DAILY Non-Insulin-Dependent PO 22-Feb-2006 08:20 AM Page: 2729 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/04/05ISR Number: 4822782-7Report Type:Expedited (15-DaCompany Report #DSA_27330_2005 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Foreign Temesta PS 5 MG 41 DAY Initial or Prolonged Varicose Vein Health Temesta SS 2.5 MG Professional Temesta SS 5 MG Other Temesta SS 2.5 MG Temesta SS 5 MG Temesta SS 6 MG Temesta SS 2 MG Temesta SS 4 MG Temesta SS 7.5 MG Alna SS 0.4 MG 6 WK Risperdal SS 6 MG 3 WK Risperdal SS 5 MG Risperdal SS 4 MG Risperdal SS 8 MG Risperdal SS 6 MG Risperdal SS 7 MG Risperdal SS 2 MG Zolden SS 10 MG 53 DAY Zolden SS 10 MG Haldol C Moduretic C Thrombo Ass C Psychopax C Trileptal C Dominal C Gewacalm C Trittico C Lovenox C Motrim C Macrogol C Pantoloc C Date:11/07/05ISR Number: 4821990-9Report Type:Expedited (15-DaCompany Report #AR-JNJFOC-20050702470 Age:23 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Increased Risperdal PS Hepatomegaly Risperdal SS Clonazepam C Date:11/07/05ISR Number: 4821991-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050906230 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Blood Glucose Decreased Risperdal Consta PS INTRAMUSCULAR start date: Hospitalization - Death Of Parent pre-Jan 2005 Initial or Prolonged Extrapyramidal Disorder Risperidone C Neuroleptic Malignant Disulfiram C Syndrome Zopiclone C Nutritional Condition Abnormal Oral Intake Reduced Schizophrenia, Catatonic Type Stress 22-Feb-2006 08:20 AM Page: 2730 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/05ISR Number: 4821992-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051100001 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Risperdal PS ORAL Date:11/07/05ISR Number: 4821993-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051100093 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperdal PS Injury Zyprexa SS Date:11/07/05ISR Number: 4821994-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040907979 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Risperdal PS ORAL Initial or Prolonged Blood Creatine Risperdal SS ORAL Phosphokinase Increased Risperdal SS ORAL Blood Creatinine Risperdal SS ORAL Increased Risperdal SS ORAL Blood Urea Increased Risperdal SS ORAL C-Reactive Protein Sodium Valproate C ORAL Increased Brotizolam C ORAL Dehydration Biperiden Nausea Hydrochloride C ORAL Poriomania Pyelonephritis Schizophrenia Date:11/07/05ISR Number: 4821995-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050704504 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Risperdal PS ORAL Initial or Prolonged Diabetes Mellitus Medazepam SS ORAL Drug Interaction Flunitrazepam SS ORAL Fall Isosorbide Dinitrate C ORAL Femoral Neck Fracture Dipyridamole C ORAL Digoxin C ORAL Furosemide C ORAL Voglibose C ORAL Levomepromazine Maleate C ORAL Date:11/07/05ISR Number: 4821996-XReport Type:Expedited (15-DaCompany Report #PH-JNJFOC-20051100275 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Prolactin Increased Risperdal PS ORAL taken at Initial or Prolonged Galactorrhoea night 11 DAY Gallbladder Disorder Oxcarbazepine C Clonazepam C 22-Feb-2006 08:20 AM Page: 2731 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/07/05ISR Number: 4821997-1Report Type:Periodic Company Report #JP-JNJFOC-20051004314 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hypokalaemia Risperdal PS ORAL No Adverse Drug Effect Risperdal SS ORAL Pancytopenia Risperdal SS ORAL Promethazine Hydrochloride C ORAL Chlorpromazine Hibenzate C ORAL Mazaticol Hydrochloride C ORAL Date:11/07/05ISR Number: 4823334-5Report Type:Expedited (15-DaCompany Report #2005BH002525 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Drug Overdose Foreign Lorazepam Initial or Prolonged Intentional Health (Lorazepam) PS ORAL 20 TAB;PO Somnolence Professional Citalopram Distributor (Citalopram) SS ORAL 20 TAB;PO Risperdal (Risperidone) SS ORAL 36 TAB;PO Stilnox SS ORAL 20 TAB;PO Date:11/07/05ISR Number: 4823488-0Report Type:Expedited (15-DaCompany Report #S05-USA-03846-01 Age:52 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Health Lexapro Initial or Prolonged Depression Professional (Escitalopram) PS ORAL 30 MG QD PO Inappropriate Schedule Of Lexapro Drug Administration (Escitalopram) SS ORAL 10 MG QD PO Mental Disorder Lexapro Paranoia (Escitalopram) SS ORAL 20 MG QD PO Psychotic Disorder Lexapro Somnolence (Escitalopram) SS ORAL 20 MG QD PO Wellbutrin (Bupropion Hydrochloride) SS Risperdal (Risperidone) SS ORAL 3 MG QD PO Risperdal (Risperidone) SS Risperdal (Risperidone) SS ORAL 0.5 MG QD PO Multivitamin C Date:11/08/05ISR Number: 4822982-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051100117 Age:24 YR Gender:Male I/FU:I Outcome PT Death Dehydration Other Diabetes Mellitus Diabetic Coma Diabetic Ketoacidosis Gastroenteritis Hypertension 22-Feb-2006 08:20 AM Page: 2732 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pain Pancreatitis Tachycardia Report Source Product Role Manufacturer Route Dose Duration Weight Increased Risperdal PS ORAL Risperdal SS ORAL Zyprexa SS ORAL Zyprexa SS ORAL Date:11/08/05ISR Number: 4822983-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051100703 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Risperdal PS ORAL taken as 0.5 mg in the am and 1.0 mg in the pm Date:11/08/05ISR Number: 4822984-XReport Type:Expedited (15-DaCompany Report #NL-JNJFOC-20051101120 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Risperdal Consta PS UNKNOWN Swelling Face Date:11/08/05ISR Number: 4823373-4Report Type:Direct Company Report #CTU 262599 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Hyperglycaemia Risperdal Consta 25mg Janssen PS Janssen INTRAMUSCULAR 25MG Q14DAYS IM Date:11/08/05ISR Number: 4824015-4Report Type:Expedited (15-DaCompany Report #143610USA Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Intentional Overdose Health Pimozide PS ORAL ORAL Hospitalization - Suicide Attempt Professional Risperidone SS INTRAMUSCULAR INTRAMUSCULAR Initial or Prolonged Date:11/08/05ISR Number: 4824761-2Report Type:Expedited (15-DaCompany Report #2005BH002637 Age:62 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oedema Peripheral Foreign Lorazepam Initial or Prolonged Varicose Vein Study (Lorazepam) PS 7.5 MG Other Alna (Tamsulosin Hydrochloride) SS 0.4 MG Risperdal (Risperidone) SS 8 MG Zolpidem (Zolpidem) SS 10 MG Haldol C Amiloride Hcl W/Hydrochlorothiazid e C Thrombo Ass C 22-Feb-2006 08:20 AM Page: 2733 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychopax C Oxcarbazepine C Dominal Forte C Gewacalm C Trittico C Lovenox C Motrim C Macrogol C Pantoprazole C Date:11/09/05ISR Number: 4823927-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050904628 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Renal Failure Acute Risperdal PS ORAL Hospitalization - Rhabdomyolysis Risperdal SS ORAL Initial or Prolonged Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Olanzapine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Carbamazepine SS ORAL Biperiden Hydrochloride C Biperiden Hydrochloride C Biperiden Hydrochloride C Diazepam C Diazepam C Nitrazepam C Clonazapine C Clonazapine C Zopiclone C Lorazepam C Loxoprofen Sodium C Loxoprofen Sodium C Rebamipide C Rebamipide C Date:11/09/05ISR Number: 4823944-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051005732 Age:23 YR Gender:Male I/FU:I Outcome Death Hospitalization - 22-Feb-2006 08:20 AM Page: 2734 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Report Source Product Role Manufacturer Route Dose Duration Death Orap PS ORAL Took 50 Overdose tablets of Suicide Attempt Orap forte 4 mg Risperdal Consta SS INTRAMUSCULAR Tavor SS UNKNOWN 8 tablets Date:11/09/05ISR Number: 4823954-8Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20051006244 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperthyroidism Risperdal Consta PS INTRAMUSCULAR Date:11/09/05ISR Number: 4823955-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051000632 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardio-Respiratory Arrest Risperdal PS ORAL Hospitalization - Convulsion Risperdal SS ORAL Initial or Prolonged Cyanosis Foaming At Mouth Date:11/09/05ISR Number: 4823957-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051100694 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal PS ORAL 3 MON Galactorrhoea Risperdal SS ORAL 3 MON Pituitary Tumour Benign Lamictal C Depakote C Date:11/09/05ISR Number: 4823958-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051101025 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Risperdal PS ORAL Congestive Date:11/09/05ISR Number: 4823959-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051101031 Age:81 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cardiac Failure Risperdal PS ORAL Congestive Date:11/09/05ISR Number: 4823960-3Report Type:Periodic Company Report #US-JNJFOC-20050806489 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Trismus Risperdal PS ORAL Wellbutrin C ORAL Neurontin C 22-Feb-2006 08:20 AM Page: 2735 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Xanax Xr C Luvox C Date:11/09/05ISR Number: 4823961-5Report Type:Periodic Company Report #DE-JNJFOC-20051002837 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other No Adverse Drug Effect Risperdal PS ORAL 6 mg at night Date:11/09/05ISR Number: 4823962-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051101422 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Colon Cancer Risperdal PS OTHER via Schizophrenia percutaneous endoscopic gastrostomy tube Date:11/09/05ISR Number: 4823963-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051101432 Age:6 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal PS ORAL Klonopin C ORAL Cogentin C (taken as 2 mg in the morning, 1 mg at noon, and 2 mg at Date:11/09/05ISR Number: 4823964-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050806617 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiomegaly Risperdal PS ORAL 187 DAY Cardiopulmonary Failure Tiotropium Bromide SS RESPIRATORY Cough (INHALATION) Dislocation Of Vertebra Prednisolone SS ORAL 95 MON Productive Cough Tulobuterol SS Trandolapril C ORAL 53 MON Sennoside C ORAL 64 MON Misoprostol C ORAL 91 MON Loxoprofen Sodium C ORAL 91 MON Quetiapine Fumarate C ORAL 9 MON Bucillamine C ORAL 4 MON Bromhexine Hydrochloride C ORAL 0 MON Zopiclone C ORAL Date:11/09/05ISR Number: 4824177-9Report Type:Expedited (15-DaCompany Report #NZ-ABBOTT-05P-118-0316138-00 Age: Gender:Female I/FU:I Outcome PT Other Neutrophil Count Decreased 22-Feb-2006 08:20 AM Page: 2736 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Report Source Product Role Manufacturer Route Dose Duration Valproate Sodium PS Risperidone SS ORAL Risperidone SS ORAL Fluoxetine C Date:11/09/05ISR Number: 4825112-XReport Type:Direct Company Report #CTU 262739 Age:56 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Ketone Body Present Risperidone 1 Mg PS ORAL 0.5 MG BID Initial or Prolonged Diabetic Ketoacidosis PO Hyperglycaemia Date:11/09/05ISR Number: 4825134-9Report Type:Direct Company Report #CTU 262754 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Increased Appetite Risperdal 0.5 Mg PS ORAL 0.5 MG PO HS Date:11/10/05ISR Number: 4824495-4Report Type:Expedited (15-DaCompany Report #JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BAge: 47NB Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Spiriva PS B.I. Pharmaceuticals,Inc. /Ridgefield RESPIRATORY (INHALATION) Risperdal SS ORAL Sennoside C ORAL Quetiapine Fumarate C ORAL Bromhexine Hydrochloride C ORAL Tulobuterol C TRANSDERMAL Prednisolone C ORAL Odric (Trandolapril) C ORAL Cytotec C ORAL Lorfenamin C ORAL Rimatil C ORAL Date:11/11/05ISR Number: 4825331-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051101577 Age:6 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electroencephalogram Risperdal PS ORAL Abnormal Insomnia Loss Of Consciousness Sleep Walking 22-Feb-2006 08:20 AM Page: 2737 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/11/05ISR Number: 4825332-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051101585 Age:5 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Decreased Activity Risperdal PS ORAL Electroencephalogram Risperdal SS ORAL Abnormal Gait Disturbance Myoclonus Date:11/11/05ISR Number: 4825343-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050205999 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Risperdal PS ORAL Hospitalization - Drug Administration Error Haloperidol SS INTRAVENOUS Initial or Prolonged Sinus Arrest Midazolam C INTRAVENOUS Propofol C INTRAVENOUS Date:11/11/05ISR Number: 4825351-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051001244 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Risperdal PS ORAL Hospitalization - Dehydration Risperdal SS ORAL Initial or Prolonged Drug Ineffective Risperdal SS ORAL Encephalitis Risperdal SS ORAL Fall Quetiapine Fumarate C ORAL Inadequate Diet Quetiapine Fumarate C ORAL Neuroleptic Malignant Etizolam C ORAL Syndrome Flunitrazepam C ORAL Open Wound Triazolam C ORAL Oral Intake Reduced Biperiden Pneumonia Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Date:11/11/05ISR Number: 4825911-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051101780 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Developmental Delay Risperdal PS Date:11/11/05ISR Number: 4825912-6Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051005433 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Delusion Risperdal PS ORAL Suicide Attempt Risperdal SS ORAL Thrombocytopenia Zyprexa SS ORAL White Blood Cell Count Zyprexa SS ORAL Decreased 22-Feb-2006 08:20 AM Page: 2738 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/05ISR Number: 4826963-8Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20051101361 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Risperdal Consta PS INTRAMUSCULAR Date:11/14/05ISR Number: 4826964-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051101653 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Risperdal PS Pregnancy Lorazepam SS Drug Withdrawal Syndrome Feeding Disorder Neonatal Irritability Neonatal Disorder Urine Output Decreased Date:11/14/05ISR Number: 4826965-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051101843 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Brain Neoplasm Risperdal PS Date:11/14/05ISR Number: 4827278-4Report Type:Expedited (15-DaCompany Report #PHBS2005JP10886 Age:91 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - C-Reactive Protein Diovan PS Novartis Sector: Initial or Prolonged Increased Pharma ORAL 80 mg/day 63360MIN Lip Haemorrhage Voltaren SS RECTAL 25 mg/day 1440 MIN Mucosal Erosion Allozym SS ORAL UNK, UNK Pharyngolaryngeal Pain Lasix SS Protein Urine Present Lorcam SS Pyrexia Aricept SS ORAL 12960MIN Rash Generalised Risperdal SS ORAL UNK, UNK 12960MIN Stevens-Johnson Syndrome Swelling Face Date:11/14/05ISR Number: 4827580-6Report Type:Expedited (15-DaCompany Report #DK-JNJFOC-20051101898 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Blinded; Initial or Prolonged Paliperidone Palmitate PS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Placebo SS INTRAMUSCULAR Rivotril C Rivotril C Rivotril C Rivotril C Imozop C 22-Feb-2006 08:20 AM Page: 2739 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/05ISR Number: 4827581-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051101947 Age:6 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coagulation Factor Vii Risperdal PS ORAL (0.5 mg in Level Decreased the morning Epistaxis and 1.25 mg Prothrombin Time at night) Prolonged Risperdal SS ORAL Date:11/14/05ISR Number: 4827582-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20051102016 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperdal PS 22 MON Insulin-Dependent Zyprexa SS 22 MON Date:11/14/05ISR Number: 4827583-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051102428 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Pulmonary Embolism Risperdal PS ORAL Hospitalization - Diet Pill Initial or Prolonged (Unspecified) C Date:11/14/05ISR Number: 4827584-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051102781 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS 45 MON Zyprexa SS 45 MON Date:11/14/05ISR Number: 4827585-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051102786 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Adverse Event Risperdal PS 22 MON Death Abilify SS 22 MON Seroquel SS 22 MON Date:11/14/05ISR Number: 4827586-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051102788 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperdal PS 27 MON Zyprexa SS 27 MON Seroquel SS 27 MON Date:11/14/05ISR Number: 4828886-7Report Type:Direct Company Report #CTU 263043 Age:12 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Risperdal PS 1 MG RISPERDAL Zoloft SS 50 MG ZOLOFT 22-Feb-2006 08:20 AM Page: 2740 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/14/05ISR Number: 4832466-7Report Type:Expedited (15-DaCompany Report #2005AL004184 Age:30 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Gabapentin Tablets, Drug Abuser Health 800 Mg (Purepac) PS Purepac ORAL PO Multiple Drug Overdose Professional Gabapentin Capsules, Intentional 400 Mg (Purepac) SS Purepac ORAL PO Respiratory Arrest Cocaine SS ORAL PO Risperidone SS ORAL PO Date:11/14/05ISR Number: 4833477-8Report Type:Expedited (15-DaCompany Report #2005AL004175 Age:86 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Lorazepam Tablets Multiple Drug Overdose Health Usp, 2 Mg (Purepac) PS Purepac ORAL PO Intentional Professional Risperidone SS PO Aspirin SS ORAL PO Date:11/14/05ISR Number: 4835141-8Report Type:Expedited (15-DaCompany Report #2005AL004166 Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Fluoxetine Oral Multiple Drug Overdose Health Solution Usp, Intentional Professional 20mg/5ml (Alpharma) PS Alpharma ORAL PO Olanzapine SS ORAL PO Risperidone SS ORAL PO Date:11/15/05ISR Number: 4828584-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050802320 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Lymphocytic Blinded; Hospitalization - Leukaemia Paliperidone Initial or Prolonged Drug Toxicity Palmitate PS INTRAMUSCULAR 35 DAY Pancytopenia Placebo SS INTRAMUSCULAR 35 DAY Rash Generalised Risperdal SS Schizophrenia Haldol SS Staphylococcal Infection Aspirin SS ORAL Tooth Extraction Glipizide SS ORAL Lisinopril SS ORAL Gabapentin SS ORAL Gabapentin SS ORAL Gabapentin SS ORAL Gabapentin SS ORAL Gabapentin SS ORAL Simvastatin SS Lorazepam SS Benztropine SS Capsaicin C 1 application taken as needed Thiamine C ORAL Docusate Sodium C ORAL Amitriptyline C ORAL Amitriptyline C ORAL Amitriptyline C ORAL 22-Feb-2006 08:20 AM Page: 2741 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Amitriptyline C ORAL Date:11/15/05ISR Number: 4830548-7Report Type:Expedited (15-DaCompany Report #2004032509 Age:45 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Aggression Consumer Zoloft (Sertraline) PS ORAL 100 MG (100 Cheilitis Health MG, 1 IN 1 Chest Pain Professional D); ORAL Condition Aggravated Geodon (Ziprasidone) SS 80 MG (80 MG, Cough 1 IN 1 D); Diarrhoea UNKNOWN Dizziness Dexamfetamine Drug Interaction (Dexamfetamine) SS Feeling Abnormal Abilify Feeling Drunk (Aripirazole) SS Formication Risperdale Hypertension (Risperidone) SS Hypothyroidism Clonazepam C Nausea Levoxyl Obsessive-Compulsive (Levothyroxine Disorder Sodium) C Palpitations Multivitamins C Panic Reaction Vitamin C C Paranoia Calcium C Rash Vitamin B Complex Restlessness (Calcium Rhinorrhoea Pantothenate, Serotonin Syndrome Nicotinamide, Somnolence Pyridoxine C Tunnel Vision Hydroxyzine C Vertigo Benadryl C Vomiting Weight Increased Date:11/15/05ISR Number: 4849604-2Report Type:Periodic Company Report #S05-USA-03878-01 Age:85 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Somnolence Consumer Namenda (Memantine) PS ORAL 5 MG QD PO Urinary Incontinence Namenda (Memantine) SS ORAL 5 MG BID PO Risperdal (Risperidone) SS 1 MG QD Date:11/15/05ISR Number: 4849626-1Report Type:Periodic Company Report #S05-USA-04009-01 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lobar Pneumonia Health Namenda (Memantine) PS ORAL 10 MG BID PO Professional Namenda (Memantine) SS ORAL 5 MG QD PO Namenda (Memantine) SS ORAL 5 MG BID PO Namenda (Memantine) SS ORAL 15 MG QD PO Risperdal (Risperidone) SS 22-Feb-2006 08:20 AM Page: 2742 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/16/05ISR Number: 4829278-7Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0360618A Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Akinesia Paxil PS Glaxosmithkline ORAL 32 WK Blood Creatine Risperidone SS ORAL 2MG Per day 2 DAY Phosphokinase Increased Artane C ORAL 2MG Three Mutism times per day 14 WK Myoclonus Solanax C ORAL .4MG Three Pain times per day 21 WK Rhabdomyolysis Silece C UNKNOWN 2MG Per day 22 WK Serotonin Syndrome Laxoberon C ORAL 2.5MG Per day 21 WK Stupor Pursennid C ORAL 12MG Per day 21 WK Date:11/16/05ISR Number: 4829551-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051101995 Age:20 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agitation Risperdal PS ORAL Hospitalization - Cardiac Arrest Risperdal SS ORAL Initial or Prolonged Dysphagia Fungizone C Dyspnoea Oral Fungal Infection Somnolence Swelling Face Date:11/16/05ISR Number: 4832031-1Report Type:Expedited (15-DaCompany Report #DSA_27346_2005 Age:72 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Decreased Foreign Temesta PS ORAL 1.5 MG Q DAY Initial or Prolonged Circulatory Collapse Health PO Contusion Professional Temesta SS ORAL 2 MG Q DAY PO Dizziness Other Temesta SS ORAL 1 MG Q DAY PO Fall Temesta SS ORAL 0.5 MG Q DAY Intracranial Injury PO Somnolence Temesta SS ORAL 0.25 MG Q DAY PO Dipiperon SS ORAL 30 MG Q DAY PO Risperdal SS ORAL 1 MG Q DAY PO Risperdal SS ORAL 2 MG Q DAY PO Spasmo-Urgenin C Aspirin Protect C Date:11/17/05ISR Number: 4832676-9Report Type:Expedited (15-DaCompany Report #HQWYE465009NOV05 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Accidental Exposure Health Effexor Xr Hospitalization - Body Temperature Professional (Venlafaxine Initial or Prolonged Increased Company Hydrochloride, General Physical Health Representative Capsule, Extended Deterioration Release) PS ORAL 225 MG 1X PER Hyperhidrosis 1 DAY, ORAL Respiratory Arrest Buspar (Buspirone Tachycardia Hydrochloride, ) SS 1 DOSAGE FORM Tremor 2X PER 1 DAY Wrong Drug Administered Risperdal 22-Feb-2006 08:20 AM Page: 2743 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Risperidone, ) SS 0.5 MG 2X PER 1 DAY Seroquel (Quetiapine, ) SS 300 MG 2X PER 1 DAY Tegretol (Carbamazepine) C Haldol (Haloperidol) C Benadryl (Diphenhydramine Hydrochloride) C Ativan (Lorazepam) C Loxitane (Loxapine) C Geodon (Ziprasidone) C Date:11/17/05ISR Number: 4832794-5Report Type:Direct Company Report #CTU 263342 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Asthenia Risperdal 2mg Required Cognitive Disorder Janssen PS Janssen ORAL 2MG TID PO 3 MON Intervention to Dizziness Prevent Permanent Ejection Fraction Impairment/Damage Decreased Fatigue Memory Impairment Myalgia Myocarditis Nausea Ventricular Dysfunction Date:11/18/05ISR Number: 4832010-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050903403 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Risperidone PS ORAL "2 dosage form daily" Risperidone SS ORAL "unknown daily" Bifeprunox SS Perphenazine C Benzhexol C Benzhexol C Chlorpromazine C Date:11/18/05ISR Number: 4832011-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050905501 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Acute Respiratory Failure Risperdal PS ORAL Hospitalization - Risperdal SS ORAL Initial or Prolonged Theophylline C ORAL Other Nitrazepam C ORAL Nifedipine C ORAL Bunazosin Hydrochloride C ORAL Distigmine Bromide C ORAL Chlormadinone Acetate C ORAL 22-Feb-2006 08:20 AM Page: 2744 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disopyramide C ORAL Pravastatin Sodium C ORAL Famotidine C ORAL Date:11/18/05ISR Number: 4833785-0Report Type:Expedited (15-DaCompany Report #2005-BP-19391RO Age:30 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cardiac Arrest Literature Cocaine (Cocaine) PS Polysubstance Abuse Health Risperidone Respiratory Arrest Professional (Risperidone) SS Gabapentin (Gabapentin) SS Date:11/18/05ISR Number: 4833940-XReport Type:Direct Company Report #CTU 263437 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Abnormal Behaviour Risperdal PS Hospitalization - Aggression Seroquel SS (?UNSURE) Initial or Prolonged Bipolar Disorder 300MG DAILY Difficulty In Walking Benadryl C Drooling Depakote C Increased Appetite Viracept C Intelligence Test Epivir C Abnormal Zerit C Mental Retardation Severity Unspecified Paralysis Staring Swelling Face Tongue Disorder Tremor Weight Increased Date:11/21/05ISR Number: 4832404-7Report Type:Expedited (15-DaCompany Report #2005AP05855 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Quetiapine Fumarate PS Zeneca Initial or Prolonged Dehydration Pharmaceutical ORAL 2 DAY Fall Quetiapine Fumarate SS Zeneca Inadequate Diet Pharmaceutical ORAL 2 DAY Insomnia Risperdal SS ORAL Neuroleptic Malignant Risperdal SS ORAL 2 DAY Syndrome Risperdal SS ORAL Open Wound Risperdal SS ORAL 2 DAY Pneumonia Etizolam C ORAL 13 DAY Flunitrazepam C ORAL Triazolam C ORAL Biperiden Hydrochloride C ORAL 2 DAY Biperiden Hydrochloride C ORAL 2 DAY 22-Feb-2006 08:20 AM Page: 2745 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/05ISR Number: 4832510-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051102977 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Electrocardiogram Qt Risperdal PS ORAL 6 DAY Prolonged Anafranil SS INTRAMUSCULAR Hypokalaemia Forlax SS ORAL Loss Of Consciousness Malaise Respiratory Arrest Shock Torsade De Pointes Date:11/21/05ISR Number: 4832511-9Report Type:Expedited (15-DaCompany Report #AT-JNJFOC-20050701941 Age:53 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal PS 38 DAY Initial or Prolonged Oedema Peripheral Risperdal SS 38 DAY Other Polydipsia Risperdal SS 38 DAY Xanor C Xanor C Xanor C Xanor C Xanor C Xanor C Akineton Ret C Nozinan C Truxal C Trittico C Xanor C Xanor C Quilonorm I Quilonorm I Quilonorm I Quilonorm I Quilonorm I Quilonorm I Date:11/21/05ISR Number: 4832512-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051103960 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Optic Neuritis Risperdal PS ORAL Date:11/21/05ISR Number: 4833210-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103593 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Immobile Risperdal Consta PS INTRAMUSCULAR Motor Dysfunction Risperdal Consta SS INTRAMUSCULAR Salivary Hypersecretion 22-Feb-2006 08:20 AM Page: 2746 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/05ISR Number: 4833211-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051103778 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS Date:11/21/05ISR Number: 4833629-7Report Type:Expedited (15-DaCompany Report #PHNU2005DE03712 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Sodium Decreased Leponex / Clozaril Initial or Prolonged Cerebral Atrophy (Clozapine) PS Novartis Sector: Communication Disorder Pharma ORAL up to 100 mg, Computerised Tomogram QD 27360MIN Abnormal Leponex / Clozaril Electroencephalogram (Clozapine) SS Novartis Sector: Abnormal Pharma ORAL up to 150 mg, Fall QD 4320 MIN Grand Mal Convulsion Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL up to 175 mg, QD 4320 MIN Nipolept SS ORAL 250 mg, QD Nipolept SS ORAL 200 mg, QD 1440 MIN Nipolept SS ORAL 175 mg, QD 1440 MIN Nipolept SS ORAL 150 mg, QD 7200 MIN Nipolept SS ORAL 100 mg, QD 2880 MIN Nipolept SS ORAL 50 mg, QD 5760 MIN Nipolept SS ORAL 300 mg, QD Zyprexa SS ORAL 20 mg, QD Zyprexa SS ORAL 25 mg, QD Zyprexa SS ORAL Ciatyl-Z SS 400 mg, BIW Risperdal SS 25 mg, BIW Date:11/21/05ISR Number: 4836556-4Report Type:Expedited (15-DaCompany Report #200513421GDS Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Baycip Life-Threatening Pneumonia Aspiration Health (Ciprofloxacin Hospitalization - Professional Hydrochloride) PS ORAL 1000 MG, Initial or Prolonged Other TOTAL DAILY, ORAL Risperdal (Risperidone) SS ORAL 3 MG, TOTAL DAILY, ORAL Aremis (Sertraline Hydrochloride) SS ORAL 50 MG, TOTAL DAILY, ORAL Rivotril (Clonazepam) SS ORAL 2 MG, TOTAL DAILY, ORAL Sinogan (Levomepromazine) SS ORAL 50 MG, TOTAL DAILY, ORAL Augmentin SS INTRAVENOUS 3000 MG, TOTAL DAILY, INTRAVENOUS Opiren C 22-Feb-2006 08:20 AM Page: 2747 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/05ISR Number: 4836984-7Report Type:Expedited (15-DaCompany Report #HQWYE495010NOV05 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Akathisia Health Pantozol Akinesia Professional (Pantoprazole) PS 40 MG 1X PER Barrett'S Oesophagus Other 1 DAY Bedridden Risperdal Body Temperature (Risperidone) SS 3 MG 1X PER 1 Increased DAY; 6 MG 1X Chills PER 1 DAY; 8 Cold Sweat MG 1X PER 1 Drug Interaction DAY; 1 MG 1X 4 DAY Enuresis Risperdal Consta Extrapyramidal Disorder (Risperidone) SS INTRAMUSCULAR 25 MG - General Physical Health FREQUENCY Deterioration UNSPECIFIED; Haematemesis 37.5 MG Hiatus Hernia (FREQUENCY 14 DAY Mobility Decreased Planum (Temazepam) C Muscle Rigidity Date:11/22/05ISR Number: 4834164-2Report Type:Expedited (15-DaCompany Report #KR-JNJFOC-20051103129 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Insipidus Risperdal PS ORAL Initial or Prolonged Hyperprolactinaemia Risperdal SS ORAL Polydipsia Lithium C Polyuria Lorazepam C Weight Increased Valproate C Valium C Benztropine C Date:11/22/05ISR Number: 4834165-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051104228 Age:66 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Serotonin Syndrome Risperdal PS ORAL Initial or Prolonged Risperdal SS ORAL Paroxetine Hydrochloride Hydrate SS Paroxetine Hydrochloride Hydrate SS Paroxetine Hydrochloride Hydrate SS Paroxetine Hydrochloride Hydrate SS Paroxetine Hydrochloride Hydrate SS Paroxetine Hydrochloride Hydrate SS Paroxetine Hydrochloride 22-Feb-2006 08:20 AM Page: 2748 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrate SS Fluvoxamine Maleate SS Trihexyphenidyl Hydrochloride C ORAL Date:11/22/05ISR Number: 4834669-4Report Type:Expedited (15-DaCompany Report #ES-GLAXOSMITHKLINE-B0396900A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Augmentin Iv PS Glaxosmithkline INTRAVENOUS 3G Per day 7 DAY Hospitalization - Dysphagia Baycip SS ORAL 1G Per day 11 DAY Initial or Prolonged Pneumonia Aremis SS ORAL 50MG Per day Pneumonia Aspiration Sinogan SS ORAL 50MG Per day Rivotril SS ORAL 2MG Per day Risperdal SS ORAL 3MG Per day Date:11/22/05ISR Number: 4834681-5Report Type:Expedited (15-DaCompany Report #ES-GLAXOSMITHKLINE-B0400887A Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Augmentin PS Glaxosmithkline INTRAVENOUS 1G Three Life-Threatening Pneumonia times per day 7 DAY Hospitalization - Baycip SS 500MG Twice Initial or Prolonged per day 11 DAY Aremis SS ORAL 50MG Per day Sinogan SS ORAL 50MG Per day Rivotril SS ORAL 1MG See dosage text Risperdal SS ORAL 3MG See dosage text Opiren SS ORAL Date:11/22/05ISR Number: 4834831-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051004309 Age:6 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Malaise Risperdal PS ORAL Pancytopenia Date:11/22/05ISR Number: 4834832-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051104568 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Coronary Artery Disease Risperdal PS Diabetes Mellitus Hyperglycaemia Tardive Dyskinesia Date:11/22/05ISR Number: 4834949-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051104763 Age:28 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Risperdal PS ORAL Breast Cancer Female Effexor Xr C Depakote C 22-Feb-2006 08:20 AM Page: 2749 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/05ISR Number: 4834950-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050500070 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Risperdal PS 7 YR Other Diabetes Mellitus Insulin-Dependent Emotional Distress Pain Date:11/22/05ISR Number: 4835437-XReport Type:Direct Company Report #CTU 263624 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Thyroid Stimulating Risperidone 4 Mg Hormone Increased Janssen PS Jassen ORAL 4 MG BEDTIME Galactorrhoea PO Hypothyroidism Venlafaxine Xr 150 Mg Wyeth SS Wyeth ORAL 150 MG MORNING PO Date:11/22/05ISR Number: 4837404-9Report Type:Expedited (15-DaCompany Report #DSA_27384_2005 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Supraventricular Foreign Tavor PS 1.25 MG Q DAY Initial or Prolonged Extrasystoles Health Edronax SS 8 MG Q DAY Tachycardia Professional Edronax SS 4 MG Q DAY Ventricular Extrasystoles Other Risperdal SS DF Detrusitol C Decortin-H C Date:11/22/05ISR Number: 4848989-0Report Type:Periodic Company Report #US-JNJFOC-20050505752 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Risperdal Consta Decreased Professional (Risperidone) Company Microspheres PS 25 MG Representative Depakote (Valproate Semisodium) C Date:11/22/05ISR Number: 4848990-7Report Type:Periodic Company Report #US-JNJFOC-20050700874 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hepatic Enzyme Increased Health Risperdal Consta Injection Site Professional (Risperidone) Haemorrhage Company Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Thrombocytopenia Representative WEEK, INTRA-MUSCULA R; SEE IMAGE Zoloft (Sertraline Hydrochloride) C 22-Feb-2006 08:20 AM Page: 2750 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/05ISR Number: 4848991-9Report Type:Periodic Company Report #US-JNJFOC-20050702277 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Neuroleptic Malignant Consumer Risperdal Consta Initial or Prolonged Syndrome Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Company WEEK, Representative INTRA-MUSCULA R Risperdal (Risperidone) Tablets SS ORAL 2 MG, IN 1 DAY, ORAL Date:11/22/05ISR Number: 4848992-0Report Type:Periodic Company Report #US-JNJFOC-20050704945 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Consumer Risperdal Consta Initial or Prolonged Insomnia Health (Risperidone) Professional Microspheres PS INTRAMUSCULAR 75 MG, IN 2 WEEK, INTRA-MUSCULA R Depakote (Valproate Semisodium) Tablets C Trazadone (Trazodone) Tablets C Cogentin (Benzatropine Mesilate) Tablets C Risperdal (Risperidone) Tablets C Date:11/22/05ISR Number: 4848999-3Report Type:Periodic Company Report #US-JNJFOC-20050806851 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Swollen Tongue Consumer Risperdal Consta (Risperidone) Microspheres PS INTRAMUSCULAR 37.5 MG, INTRAMUSCULAR Date:11/22/05ISR Number: 4849000-8Report Type:Periodic Company Report #US-JNJFOC-20050803148 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delirium Health Risperdal Consta Initial or Prolonged Mental Disorder Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRAMUSCULAR 22-Feb-2006 08:20 AM Page: 2751 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/05ISR Number: 4849001-XReport Type:Periodic Company Report #US-JNJFOC-20050804595 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Psychotic Disorder Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Tablets SS ORAL 4 MG, 2 IN 1 DAY, ORAL Abilify (Aripiprazole) C Thorazine (Chlorpromazine Hydrochloride) C Date:11/22/05ISR Number: 4849002-1Report Type:Periodic Company Report #US-JNJFOC-20050804784 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Consumer Risperdal Consta Initial or Prolonged Confusional State (Risperidone) Delusion Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Insomnia WEEK, Irritability INTRA-MUSCULA Paranoia R; SEE IMAGE Risperdal (Risperidone) Tablets SS ORAL ORAL Depakote (Valproate Semisodium) C Date:11/22/05ISR Number: 4849003-3Report Type:Periodic Company Report #US-JNJFOC-20050805427 Age:60 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Pyrexia Consumer Risperdal Consta Hospitalization - Schizophrenia Health (Risperidone) Initial or Prolonged Professional Microspheres PS INTRAMUSCULAR 25 MG, Company INTRAMUSCULAR Representative Lamictal (Lamotrigine) C Date:11/22/05ISR Number: 4849004-5Report Type:Periodic Company Report #US-JNJFOC-20050800322 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Consumer Risperdal Consta Initial or Prolonged Health (Risperidone) Other Professional Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 WEEK, INTRA-MUSCULA R Topamax (Topiramate) Unspecified C 22-Feb-2006 08:20 AM Page: 2752 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seroquel (Quetiapine Fumarate) C Lexapro (All Other Therapeutic Products) Tablets C Zantac (Ranitidine Hydrochloride) C Maxide (Dyazide) C Date:11/22/05ISR Number: 4849005-7Report Type:Periodic Company Report #US-JNJFOC-20051005210 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Risperdal Consta Initial or Prolonged Schizophrenia Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Representative WEEK, INTRA-MUSCULA R Risperdal Consta (Risperidone) Tablets SS ORAL 4 MG, 1 IN 1 DAY, ORAL Date:11/22/05ISR Number: 4849009-4Report Type:Periodic Company Report #US-JNJFOC-20051005213 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeling Hot Consumer Risperdal Consta Hallucination, Auditory (Risperidone) Pharyngolaryngeal Pain Microspheres PS INTRAMUSCULAR 25 MG, 1 IN 2 Suicidal Ideation WEEK, INTRA-MUSCULA R Nasocort (Budesonide) C Date:11/22/05ISR Number: 4849013-6Report Type:Periodic Company Report #US-JNJFOC-20051002996 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthenia Health Risperdal Consta Decreased Appetite Professional (Risperidone) Insomnia Company Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Suicidal Ideation Representative WEEK, INTRA-MUSCULA R Date:11/22/05ISR Number: 4849014-8Report Type:Periodic Company Report #US-JNJFOC-20051001614 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Priapism Health Risperdal Consta Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Representative WEEK, INTRA-MUSCULA 22-Feb-2006 08:20 AM Page: 2753 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report R Date:11/22/05ISR Number: 4849015-XReport Type:Periodic Company Report #US-JNJFOC-20051000965 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Ineffective Health Risperdal Consta Initial or Prolonged Professional (Risperidone) Microspheres PS Date:11/22/05ISR Number: 4849016-1Report Type:Periodic Company Report #US-JNJFOC-20050906828 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Consumer Risperdal Consta Initial or Prolonged Schizophrenia, Paranoid Health (Risperidone) Type Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Weight Decreased WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Tablets C Date:11/22/05ISR Number: 4849017-3Report Type:Periodic Company Report #US-JNJFOC-20050905381 Age:63 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination Consumer Risperdal Consta Initial or Prolonged Tardive Dyskinesia (Risperidone) Other Microspheres PS INTRAMUSCULAR INTRA-MUSCULA R Risperdal Consta (Risperidone) Unspecified SS Date:11/22/05ISR Number: 4849018-5Report Type:Periodic Company Report #US-JNJFOC-20050902696 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Risperdal Consta Syndrome Professional (Risperidone) Rhabdomyolysis Company Microspheres PS Representative Date:11/22/05ISR Number: 4849019-7Report Type:Periodic Company Report #US-JNJFOC-20050902754 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Health Risperdal Consta Decreased Professional (Risperidone) Microspheres PS INTRAMUSCULAR 75 MG, INTRA-MUSCULA R 22-Feb-2006 08:20 AM Page: 2754 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/22/05ISR Number: 4849020-3Report Type:Periodic Company Report #US-JNJFOC-20050901917 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Health Risperdal Consta Professional (Risperidone) Company Microspheres PS INTRAMUSCULAR 50 MG, Representative INTRAMUSCULAR Date:11/22/05ISR Number: 4849021-5Report Type:Periodic Company Report #US-JNJFOC-20050800479 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Consumer Risperdal Consta Drug Level Decreased Health (Risperidone) Grand Mal Convulsion Professional Microspheres PS INTRAMUSCULAR SEE IMAGE Hallucination Risperdal Consta Therapeutic Response (Risperidone) Decreased Tablets SS ORAL 6 MG, IN 1 DAY, ORAL Dilantin (Phenytoin Sodium) SS ORAL SEE IMAGE Risperdal Consta (Risperidone) Microspheres SS Risperdal Consta (Risperidone) Microspheres SS Synthroid (Levothyroxine Sodium) C Prilosec (Omeprazole) C Ativan (Lorazem) C Reglan (Metoclopramide) C Colace (Docusate Sodium) C Loratadine (Loratadine) C Ranitidine (Ranitide) C Ibuprofen (Ibuprofen) C Date:11/22/05ISR Number: 4849022-7Report Type:Periodic Company Report #US-JNJFOC-20051002360 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neuroleptic Malignant Health Risperidone Syndrome Professional (Risperidone) Microspheres PS INTRAMUSCULAR 25 MG, INTRA-MUSCULA R 22-Feb-2006 08:20 AM Page: 2755 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/23/05ISR Number: 4836289-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103405 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperdal PS ORAL Initial or Prolonged Blood Creatine Ciatyl-Z Acuphase SS INTRAMUSCULAR Phosphokinase Increased Ciatyl-Z Acuphase SS INTRAMUSCULAR Body Temperature Haloperidol SS INTRAMUSCULAR Increased Hypnorex SS Chills Tavor Expidet C ORAL Disturbance In Attention Date:11/23/05ISR Number: 4836290-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050904648 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Arrhythmia Risperdal PS ORAL Hospitalization - Atherosclerosis Risperdal SS ORAL Initial or Prolonged Cardiac Failure Other Congestive Myocardial Infarction Date:11/23/05ISR Number: 4836291-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103846 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Fall Nipolept SS ORAL Grand Mal Convulsion Leponex SS ORAL 125-150mg Hyponatraemia daily Motor Dysfunction Leponex SS ORAL 25-100mg Postictal State daily Zyprexia SS ORAL Ciatyl-Z - Slow Release SS Date:11/23/05ISR Number: 4836293-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103847 Age:56 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Risperdal PS ORAL Initial or Prolonged Supraventricular Edronax SS ORAL Extrasystoles Edronax SS ORAL Tachycardia Tavor SS ORAL Ventricular Extrasystoles Detrusitol C ORAL Decortin H C ORAL Date:11/23/05ISR Number: 4836294-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050100908 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Anaemia Initial or Prolonged Blood Cholinesterase Other Decreased Dysphagia Extrapyramidal Disorder Hypercholesterolaemia Hypokalaemia 22-Feb-2006 08:20 AM Page: 2756 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypoproteinaemia Malnutrition Pneumonia Aspiration Report Source Product Role Manufacturer Route Dose Duration Weight Decreased Risperdal PS ORAL White Blood Cell Count Risperdal SS ORAL Increased Risperdal SS ORAL Risperdal SS ORAL Risperdal SS ORAL Biperiden Hydrochloride C ORAL Flunitrazepam C ORAL Lorazepam C ORAL Mosapride Citrate C ORAL Date:11/23/05ISR Number: 4836295-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051104859 Age:33 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal PS ORAL Initial or Prolonged Electrocardiogram Qt Risperdal SS ORAL Other Corrected Interval Olanzapine C Prolonged Lithium Carbonate I ORAL Levomepromazine Maleate I ORAL Date:11/23/05ISR Number: 4836423-6Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20051101361 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Risperdal Consta PS INTRAMUSCULAR Date:11/23/05ISR Number: 4836424-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050905168 Age:88 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Risperdal PS ORAL (dose divided Initial or Prolonged Cardiac Disorder and taken Other Dehydration three times Oedema daily) Somnolence Risperdal SS ORAL Weight Decreased Risperdal SS ORAL Amlodipine Besilate C ORAL Date:11/23/05ISR Number: 4836749-6Report Type:Expedited (15-DaCompany Report #DE-ABBOTT-05P-062-0317348-00 Age:54 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Nipolept PS ORAL Initial or Prolonged Communication Disorder Nipolept SS ORAL Depressed Level Of Nipolept SS ORAL Consciousness Nipolept SS ORAL Fall Nipolept SS ORAL Grand Mal Convulsion Nipolept SS ORAL Masked Facies Clozapine SS ORAL 22 DAY Clozapine SS ORAL 22 DAY Clozapine SS ORAL 22 DAY Olanzapine SS ORAL 22-Feb-2006 08:20 AM Page: 2757 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Olanzapine SS ORAL Olanzapine SS ORAL Zuclopenthixol Hydrochloride SS Risperidone SS Chlorprothixene Hydrochloride C Saroten C Lorazepam C Haloperidol C Isopromethazine Hydrochloride C Flunitrazepam C Lorazepam C Date:11/25/05ISR Number: 4839957-3Report Type:Expedited (15-DaCompany Report #2005RR-01171 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Fluoxetine Drug Level Increased Other (Fluoxetine) Hepatitis Cholestatic Capsule, 20mg PS 20 MG, QD Hepatotoxicity Risperidone (Risperidone) SS 2 MG, QD Metamizol C Diazepam (Diazepam) C Omeprazole (Omeprazole) C Fentanyl C Heparin C Date:11/25/05ISR Number: 4841799-XReport Type:Expedited (15-DaCompany Report #2005-DE-04900GD Age:86 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Aspirin PS ORAL PO Multiple Drug Overdose Lorazepam (Lorazepam) SS ORAL PO Risperidone (Risperidone) SS ORAL PO Date:11/25/05ISR Number: 4842258-0Report Type:Expedited (15-DaCompany Report #2005156076 Age:77 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amnesia Consumer Norvasc (Amlodipine) PS ORAL 5 MG (5 MG, 1 Initial or Prolonged Confusional State IN 1 D), ORAL Other Fall Risperdal Hallucination (Risperidone) SS INTRAVENOUS (1 IN 1 D), Loss Of Consciousness INTRAVENOUS Benazepril Hydrochloride (Benazepril Hydrochloride) C Toprol Xl (Metoprolol Succinate) C Pravachol 22-Feb-2006 08:20 AM Page: 2758 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Pravastatin Sodium) C Synthroid (Levothyroxine Sodium) C Date:11/25/05ISR Number: 4844603-9Report Type:Expedited (15-DaCompany Report #2005157366 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Foreign Neurontin Initial or Prolonged Rash Generalised Health (Gabapentin) PS ORAL 800 MG (1 D), Rash Maculo-Papular Professional ORAL Rash Pruritic Risperdal (Risperidone) SS Remergil (Mirtazapine) SS 30 MG (1 D) Eunerpan (Melperone Hydrochloride) SS 50 MG (1 D) Date:11/25/05ISR Number: 4846341-5Report Type:Expedited (15-DaCompany Report #2005139478 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Aremis (Sertraline) PS ORAL 50 MG (100 Hospitalization - Bronchospasm Health MG, 1 IN 1 Initial or Prolonged Drug Interaction Professional D), ORAL Other Pneumonia Aspiration Sinogan Respiratory Tract (Levomepromazine) SS ORAL 50 MG (100 Infection MG, 1 IN 1 Tachypnoea D), ORAL Augmentine (Amoxicillin Sodium, Amoxicillin Trihydrate, Clavulanate SS INTRAVENOUS 3 GRAM/600 MG (3 IN 1 D), INTRAVENOUS Ciprofloxacin (Ciprofloxacin) SS ORAL 1 GRAM (500 MG, 2 IN 1 D), ORAL Rivotril (Clonazepam) SS ORAL 2 MG (2 MG, 1 IN 1 D), ORAL Risperdal (Risperidone) SS ORAL 3 MG (3 MG, 1 IN 1 D), ORAL Lansoprazol (Lansoprazole) C Date:11/28/05ISR Number: 4837419-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103898 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Haldol PS ORAL General Symptom Risperdal SS ORAL 22-Feb-2006 08:20 AM Page: 2759 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/05ISR Number: 4837448-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103851 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Risperdal Consta PS INTRAMUSCULAR Increased Risperdal SS ORAL Aspartate Zyprexa SS 20-35 mg 113 DAY Aminotransferase Zyprexa SS 20-35 mg 113 DAY Increased Atrioventricular Block First Degree Bundle Branch Block Right Electrocardiogram Pq Interval Prolonged Liver Function Test Abnormal Date:11/28/05ISR Number: 4837449-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051104181 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acute Psychosis Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Aggression Risperdal Consta SS INTRAMUSCULAR Psychomotor Hyperactivity Risperidone C ORAL Risperidone C ORAL Risperidone C ORAL Tercian C Tercian C Date:11/28/05ISR Number: 4837450-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051104206 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thrombosis Risperdal Consta PS UNKNOWN Date:11/28/05ISR Number: 4837451-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051104209 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal Consta PS UNKNOWN Fluoxetine C UNKNOWN Amisulpiride C UNKNOWN Date:11/28/05ISR Number: 4837452-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051104509 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal Consta PS INTRAMUSCULAR Phosphokinase Increased Risperdal Consta SS INTRAMUSCULAR Extrapyramidal Disorder Tavor C ORAL Pyrexia Tavor C ORAL Tavor C ORAL 22-Feb-2006 08:20 AM Page: 2760 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/05ISR Number: 4837453-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103885 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Granulocytosis Risperdal PS ORAL Initial or Prolonged Pyrexia Risperdal SS ORAL Risperdal SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Risperdal SS ORAL Date:11/28/05ISR Number: 4837454-2Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20051104183 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Risperdal PS ORAL Life-Threatening Drug Interaction Opiren C ORAL Hospitalization - Pneumonia Aspiration Aremis I ORAL Initial or Prolonged Rivotril I ORAL Other Sinogan I ORAL Baycip I ORAL Augmentine I INTRAPLEURAL Augmentine I INTRAPLEURAL Date:11/28/05ISR Number: 4837455-4Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20051104201 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Congestive Cardiomyopathy Risperdal PS ORAL Initial or Prolonged Risperdal SS ORAL Date:11/28/05ISR Number: 4837456-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051104496 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polycythaemia Risperdal PS UNKNOWN Date:11/28/05ISR Number: 4837457-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050804935 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Risperdal PS UNKNOWN Date:11/28/05ISR Number: 4837458-XReport Type:Expedited (15-DaCompany Report #AU-JNJFOC-20051104835 Age:93 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal PS Pulmonary Oedema 22-Feb-2006 08:20 AM Page: 2761 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/05ISR Number: 4837459-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103880 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cold Sweat Risperdal PS ORAL Dyspnoea Risperdal SS ORAL Hemiparesis Risperdal SS ORAL Risperdal SS ORAL Delix C ORAL Metformin C ORAL Insulin C Date:11/28/05ISR Number: 4837460-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051104501 Age:76 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Atrial Fibrillation Risperdal PS ORAL Fibrin D Dimer Increased Risperdal SS ORAL Hypotension Risperdal SS ORAL Edronax SS ORAL Edronax SS ORAL Risperdal SS ORAL Risperdal SS ORAL Tavor C ORAL Tavor C ORAL Furosemid C ORAL Date:11/28/05ISR Number: 4837461-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051003493 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Dermatitis Risperdal PS ORAL Reaction To Drug Risperdal SS ORAL Excipients Date:11/28/05ISR Number: 4837462-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050906809 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bulimia Nervosa Risperdal PS ORAL Gynaecomastia Tranxene C Weight Increased Date:11/28/05ISR Number: 4837463-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051105494 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Intentional Overdose Risperdal PS ORAL Overdose Risperdal SS ORAL Respiratory Depression Zyprexa SS ORAL Suicide Attempt Zyprexa SS ORAL Vomiting 22-Feb-2006 08:20 AM Page: 2762 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/05ISR Number: 4837464-5Report Type:Expedited (15-DaCompany Report #SE-JNJFOC-20051105514 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Risperdal PS ORAL Initial or Prolonged Insulin-Dependent Theralen C Hyperglycaemia Theralen C Tegretol C Trimonil C Esucos C 10mg mane (in the morning) Esucos C Date:11/28/05ISR Number: 4837467-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103881 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Risperdal PS ORAL Initial or Prolonged Femoral Neck Fracture Risperdal SS ORAL Pleurothotonus Risperdal SS ORAL Reminyl SS ORAL Risperdal SS ORAL Delix C ORAL Folsan C Decostriol C Ass C ORAL Distraneurin C ORAL Distraneurin C ORAL Distraneurin C ORAL Distraneurin C ORAL Date:11/28/05ISR Number: 4837994-6Report Type:Expedited (15-DaCompany Report #ES-ROCHE-420481 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Rivotril PS Roche ORAL Hospitalization - Aspiration Opiren C ORAL DRUG REPORTED Initial or Prolonged Drug Interaction AS OPIREN Pneumonia FLAS. Baycip I ORAL 11 DAY Augmentin I INTRAVENOUS 7 DAY Aremis I ORAL Sinogan I ORAL Risperdal I ORAL Date:11/28/05ISR Number: 4838047-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051105077 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coronary Artery Disease Risperdal PS took 0.5 mg - Initial or Prolonged Myocardial Infarction 1 mg daily "depends" Blood Pressure Medication C 22-Feb-2006 08:20 AM Page: 2763 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/28/05ISR Number: 4838048-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051105079 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal Consta PS OTHER Platelet Count Decreased Date:11/28/05ISR Number: 4838121-1Report Type:Expedited (15-DaCompany Report #2005AP05976 Age:30184 DYGender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Pneumonia Aspiration Seroquel PS Zeneca Pharmaceutical ORAL Seroquel SS Zeneca Pharmaceutical ORAL Gramalil SS ORAL Risperdal SS ORAL Myslee C ORAL Date:11/29/05ISR Number: 4844688-XReport Type:Expedited (15-DaCompany Report #B0400943A Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Chloride Decreased Literature Paxil (Paroxetine Initial or Prolonged Blood Osmolarity Health Hydrochloride) PS Decreased Professional Carbamazepine Blood Sodium Decreased (Formulation Dizziness Unknown) Grand Mal Convulsion (Carbamazepine) SS Hyponatraemia Risperidone Loss Of Consciousness (Formulation Nystagmus Unknown) Overdose (Risperidone) SS 4 MG/ TWICE Sensory Disturbance PER DAY/ Treatment Noncompliance UNKNONW Visual Disturbance Buspirone C Nadolol C Hydroxyzine C Date:11/30/05ISR Number: 4840695-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051104589 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Dissociation Risperdal C ORAL Drug Abuser Risperdal C ORAL Risperdal C ORAL Risperdal C ORAL prior to enrollment in study Date:11/30/05ISR Number: 4840696-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051104598 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Dissociation Risperdal C ORAL Drug Abuser Risperdal C ORAL 22-Feb-2006 08:20 AM Page: 2764 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal C ORAL Risperdal C ORAL Risperdal C ORAL prior to enrollment in study Date:11/30/05ISR Number: 4840697-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051105072 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal PS ORAL Date:11/30/05ISR Number: 4840698-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051105511 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agranulocytosis Risperdal PS ORAL Remergil SS ORAL Carbimazol SS ORAL Delix SS ORAL Date:11/30/05ISR Number: 4840699-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051002824 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Risperdal PS ORAL Depressed Level Of Risperdal SS ORAL Consciousness Zotepine C ORAL Disseminated Haloperidol C ORAL Intravascular Coagulation Lithium Carbonate C ORAL Neuroleptic Malignant Sodium Valproate C ORAL Syndrome Phenytoin C ORAL Respiratory Failure Date:11/30/05ISR Number: 4840700-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103885 Age:45 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Risperdal PS ORAL Initial or Prolonged Pyrexia Risperdal SS ORAL Risperdal SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Leponex SS ORAL Risperdal SS ORAL 22-Feb-2006 08:20 AM Page: 2765 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/05ISR Number: 4840701-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20041105096 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Risperdal PS ORAL the patient Initial or Prolonged Overdose took 25 tablets at one time Date:11/30/05ISR Number: 4841156-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13146394 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Abilify PS Otsuka Pharmaceuticals Europe Limited Risperidone SS Seroquel SS Date:11/30/05ISR Number: 4842048-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050500070 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Risperdal PS 7 YR Other Diabetes Mellitus Insulin-Dependent Emotional Distress Pain Date:11/30/05ISR Number: 4863016-7Report Type:Periodic Company Report #FABR-11160 Age:62 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Asthenia Foreign Fabrazyme PS INTRAVENOUS 70 MG IV Confusional State Health Fabrazyme SS INTRAVENOUS 70 MG Q2WKS Depression Professional IV Dizziness Company Risperdal SS Dyspnoea Representative Risperdal SS 0.5 MG QD Gait Disturbance Other Risperdal SS 1.5 MG QD Hyperhidrosis Remeron SS 15 MG QD Tachycardia Remeron SS 15 MG QD Remeron SS Aricept SS 5 MG QD Aricept SS 5 MG QD Risperdal C Remeron C Aricept C Dumyrox C Date:12/01/05ISR Number: 4842377-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051105757 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alcoholism Risperdal PS UNKNOWN Drug Abuser Alcoholic Beverage SS UNKNOWN Overdose 22-Feb-2006 08:20 AM Page: 2766 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/01/05ISR Number: 4842378-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051104598 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dissociation Risperdal Consta PS INTRAMUSCULAR prior to Initial or Prolonged enrollment in study Risperdal Consta SS INTRAMUSCULAR Risperdal C ORAL Risperdal C ORAL Risperdal C ORAL Risperdal C ORAL Risperdal C ORAL Date:12/01/05ISR Number: 4842380-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051104589 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Risperdal Consta PS INTRAMUSCULAR prior to Initial or Prolonged Dissociation enrollment in Drug Abuser study Risperdal Consta SS INTRAMUSCULAR Risperdal C ORAL Risperdal C ORAL Risperdal C ORAL Date:12/01/05ISR Number: 4846115-5Report Type:Expedited (15-DaCompany Report #2005160772 Age:39 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Increased Health Zoloft (Sertraline) PS Initial or Prolonged Infection Professional Risperdal Other Paranoia (Risperidone) SS Sepsis Lantus (Insulin Somnolence Glargine) SS SUBCUTANEOUS 100, SUBCUTANEOUS Baclofen (Baclofen) C Diflucan (Fluconazole) C Zinc (Zinc) C Omeprazole (Omeprazole) C Vitamin C (Vitamin C) C Lasix (Furosemide) C Vancomycin (Vancomycin) C Maxaquin (Lomefloxacin Hydrochloride) C All Other Therapeutic Products (All Other Therapeutic Products) C 22-Feb-2006 08:20 AM Page: 2767 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/01/05ISR Number: 4846773-5Report Type:Expedited (15-DaCompany Report #2005138272 Age:36 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Consumer Geodon (Ziprasidone) PS ORAL 80 MG (80 MG, Initial or Prolonged Increased Health 1 IN 1 D), Disability Condition Aggravated Professional ORAL Other Diarrhoea Navane (Capsules) Drug Ineffective (Thiothixene) SS ORAL ORAL Gastrooesophageal Reflux Depakote (Valproate Disease Semisodium) SS Insomnia All Other Sleep Apnoea Syndrome Therapeutic Agents SS Tremor Risperdal Weight Increased (Risperidone) SS All Other Therapeutic Agents SS Insulin (Insulin) C Anti-Diabetics (Anti-Diabetics) C Metformin (Metformin) C Citalopram (Citalopram) C Date:12/02/05ISR Number: 4843643-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051100022 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Hyperprolactinaemia Other Pituitary Tumour Benign Date:12/02/05ISR Number: 4843644-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051105994 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Nephrolithiasis Risperdal PS ORAL Renal Colic Date:12/02/05ISR Number: 4843653-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051105515 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Drug Interaction Risperdal PS UNKNOWN Hospitalization - Leukopenia Topamax SS ORAL Initial or Prolonged Neutropenia Cipramil SS Date:12/02/05ISR Number: 4843654-8Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051003488 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Risperdal PS UNKNOWN Initial or Prolonged Hyperglycaemia Pancreatic Carcinoma 22-Feb-2006 08:20 AM Page: 2768 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/02/05ISR Number: 4843655-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051105755 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Risperdal PS ORAL 41 DAY Initial or Prolonged Neutropenia Risperdal SS ORAL 41 DAY Fludex C Lercan C Parkinane C Loxapac C INTRAVENOUS Date:12/02/05ISR Number: 4843656-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103593 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Immobile Risperdal Consta PS INTRAMUSCULAR Salivary Hypersecretion Risperdal Consta SS INTRAMUSCULAR Date:12/02/05ISR Number: 4843657-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051101653 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Feeding Disorder Neonatal Risperdal PS Irritability Lorazepam SS Urine Output Decreased Date:12/02/05ISR Number: 4843659-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051106439 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Risperdal PS ORAL Death Date:12/02/05ISR Number: 4843660-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050205090 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Herpes Zoster Risperdal PS ORAL Initial or Prolonged Inappropriate Ciclosporin C Other Antidiuretic Hormone Nilvadipine C ORAL Secretion Metoprolol Tartrate C ORAL Methylprednisolone C ORAL Bromazepam C ORAL Azathioprine C Date:12/02/05ISR Number: 4846441-XReport Type:Expedited (15-DaCompany Report #2005159160 Age:44 YR Gender:Male I/FU:I Outcome PT Hospitalization - Adverse Drug Reaction Initial or Prolonged Delusion Other Fatigue Hallucination Heart Rate Irregular Overweight Somnolence Vomiting 22-Feb-2006 08:20 AM Page: 2769 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Weight Increased Report Source Product Role Manufacturer Route Dose Duration Consumer Zoloft (Sertraline) PS ORAL 200 MG (200 MG, 1 IN 1 D), ORAL Geodon (Ziprasidone) SS ORAL ORAL Risperdal (Risperidone) SS Date:12/02/05ISR Number: 4846620-1Report Type:Expedited (15-DaCompany Report #GXKR2005ES01979 Age:64 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Foreign Risperidone (Ngx) Hepatitis Cholestatic Literature (Risperidone) Hepatotoxicity Health Unknown PS 2 MG, UNK Professional Fluoxetine (Ngx) Other (Fluoxetine) Unknown SS 20 MG, UNK Metamizole (Metamizole) C Diazepam (Diazepam) C Omeprazole (Omeprazole) C Fentanyl (Fentanyl) C Heparin (Heparin) C Date:12/05/05ISR Number: 4844669-6Report Type:Expedited (15-DaCompany Report #JP-BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.-2005-BAge: 47NB Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Spiriva PS B.I. Sudden Death Pharmaceuticals,Inc. /Ridgefield RESPIRATORY (INHALATION) Risperdal SS ORAL Sennoside C ORAL Quetiapine Fumarate C ORAL Bromhexine Hydrochloride C ORAL Tulobuterol C TRANSDERMAL Prednisolone C ORAL Odric (Trandolapril) C ORAL Cytotec C ORAL Lorfenamin C ORAL Rimatil C ORAL Date:12/05/05ISR Number: 4844857-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051105772 Age:23 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal PS ORAL Galactorrhoea Risperdal SS ORAL Obesity Pituitary Tumour Benign 22-Feb-2006 08:20 AM Page: 2770 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/05/05ISR Number: 4844858-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051106294 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal Consta PS INTRAMUSCULAR Phosphokinase Increased Inappropriate Schedule Of Drug Administration Pyrexia Date:12/05/05ISR Number: 4844859-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051101051 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Angioneurotic Oedema Risperdal PS ORAL Initial or Prolonged Balance Disorder Diamicron C Dose = Tablet Eye Rolling Glucophage C Dose = Tablet Faecal Incontinence Exelon C Fall Fatigue Gait Disturbance Hyperglycaemia Hypertension Ill-Defined Disorder Musculoskeletal Stiffness Myocardial Infarction Swelling Face Urinary Incontinence Date:12/05/05ISR Number: 4845029-4Report Type:Expedited (15-DaCompany Report #2005AP05855 Age:9917 DY Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Quetiapine Fumarate PS Zeneca Hospitalization - Dehydration Pharmaceutical ORAL 2 DAY Initial or Prolonged Encephalitis Quetiapine Fumarate SS Zeneca Fall Pharmaceutical ORAL 2 DAY Inadequate Diet Risperdal SS ORAL Neuroleptic Malignant Risperdal SS ORAL 2 DAY Syndrome Risperdal SS ORAL Open Wound Risperdal SS ORAL 2 DAY Pneumonia Etizolam C ORAL 12 DAY Treatment Noncompliance Flunitrazepam C ORAL Triazolam C ORAL Biperiden Hydrochloride C ORAL 2 DAY Biperiden Hydrochloride C ORAL 2 DAY Date:12/05/05ISR Number: 4847649-XReport Type:Expedited (15-DaCompany Report #2005119101 Age:85 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Foreign Zoloft (Sertraline) PS ORAL 20 MG (1 D), Initial or Prolonged First Degree Health ORAL Other Cerebral Atrophy Professional Aricept (Donepezil) SS ORAL 10 MG (1 D), Dysphagia ORAL Facial Palsy Equanil Ischaemic Stroke (Meprobamate) SS ORAL 200 MG (1 D), 22-Feb-2006 08:20 AM Page: 2771 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report ORAL Risperdal (Risperidone) SS ORAL 1 MG (1 D), ORAL Deroxat (Paroxetine Hydrochloride) C Date:12/06/05ISR Number: 4846586-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051106285 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal PS ORAL Date:12/06/05ISR Number: 4848649-6Report Type:Expedited (15-DaCompany Report #2005160773 Age:87 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchitis Chronic Foreign Prednisolone Other Cardiomegaly Consumer (Prednisolone) PS ORAL 5 MG (5MG,1 Cardiopulmonary Failure IN 1 D), ORAL Charles Bonnet Syndrome Tiotropium Bromide Cough (Tiotropium Bromide) SS RESPIRATORY Dislocation Of Vertebra (INHALATION) 18 MCG (18 Hallucination, Visual MCG, 1 IN 1 Productive Cough D), INHALATION Risperdal (Risperidone) SS ORAL 0.5 MG (0.5 MG, 1 IN 1 D), ORAL Tulobuterol (Tulobuterol) SS 2 MG (2 MG, 1 IN 1 DAY) Trandolapril (Trandolapril) C Sennosides (Sennoside A+B) C Misoprostol (Misoprostol) C Loxoprofen Sodium (Loxoprofen Sodium) C Quetiapine Fumarate (Quetiapine Fumarate) C Bucillamine (Bucillamine) C Bromhexine Hydrochloride (Bromhexine Hydrochloride) C Zopiclone (Zopiclone) C Date:12/07/05ISR Number: 4847008-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051102497 Age: Gender:Female I/FU:I Outcome Hospitalization - Initial or Prolonged 22-Feb-2006 08:20 AM Page: 2772 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disability PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Risperdal PS ORAL Neuroleptic Malignant Risperdal SS ORAL Syndrome Haloperidol I INTRAMUSCULAR Biperiden Hydrochloride I ORAL Biperiden Hydrochloride I ORAL Fluphenazine Decanoate I INTRAMUSCULAR Chlorpromazine Hydrochloride/Promet hazine Hydrochloride/Phenob arbital I ORAL Levomepromazine Maleate I ORAL Olanzapine I ORAL Quetiapine Fumarate I ORAL Date:12/07/05ISR Number: 4847010-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051106647 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hypoxic Encephalopathy Risperdal PS ORAL Respiratory Arrest Risperdal SS ORAL Clotiazepam C ORAL Date:12/07/05ISR Number: 4847012-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051200425 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Road Traffic Accident Risperdal PS UNKNOWN Date:12/07/05ISR Number: 4847013-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051200833 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Cholangitis Risperdal Consta PS INTRAMUSCULAR Date:12/07/05ISR Number: 4847014-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051100694 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal PS ORAL Galactorrhoea Risperdal SS ORAL Prolactinoma Lamictal C (at bedtime) Depakote Er C 500 mg dose (3 doses taken at bedtime) 22-Feb-2006 08:20 AM Page: 2773 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/07/05ISR Number: 4847015-7Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051200854 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hepatic Neoplasm Risperdal PS ORAL 2 YR Initial or Prolonged Malignant Duragesic C Other Pancreatitis Dilaudid C ORAL Date:12/08/05ISR Number: 4848247-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051004886 Age:29 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Lupus-Like Syndrome Risperdal PS ORAL Flunitrazepam C ORAL Clonazepam C ORAL Date:12/08/05ISR Number: 4848681-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050500070 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Risperdal PS ORAL Initial or Prolonged Back Pain Risperdal SS ORAL Disability Bronchitis Risperdal SS ORAL Other Diabetes Mellitus Depakote C ORAL Insulin-Dependent Diabetic Ketoacidosis Hepatomegaly Major Depression Pain Pharyngitis Streptococcal Sinusitis Date:12/08/05ISR Number: 4850755-7Report Type:Direct Company Report #CTU 264658 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiratory Arrest Risperidone 0.25mg Initial or Prolonged Po Q12h Prn PS Date:12/09/05ISR Number: 4849075-6Report Type:Expedited (15-DaCompany Report #2005AP05976 Age:30183 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Seroquel PS Zeneca Dysphagia Pharmaceutical ORAL 32 DAY Pneumonia Aspiration Seroquel SS Zeneca Pharmaceutical ORAL Gramalil SS ORAL 52 DAY Gramalil SS ORAL Risperdal SS ORAL 52 DAY Risperdal SS ORAL Myslee C ORAL 53 DAY Myslee C ORAL 22-Feb-2006 08:20 AM Page: 2774 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/09/05ISR Number: 4849251-2Report Type:Expedited (15-DaCompany Report #NZ-JNJFOC-20051106262 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal PS Decreased Date:12/12/05ISR Number: 4850816-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103704 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Ileus Durogesic Smat PS TRANSDERMAL 193 DAY Other Megacolon Risperdal SS ORAL Sepsis Melperon C ORAL Urinary Tract Infection Captoflux C UNKNOWN Reminyl C ORAL Date:12/12/05ISR Number: 4851053-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051201355 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Haematemesis Risperdal Consta PS INTRAMUSCULAR Hospitalization - Initial or Prolonged Disability Other Date:12/12/05ISR Number: 4851054-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20051201467 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Risperdal PS ORAL Initial or Prolonged Balance Disorder Zoloft C Oral Intake Reduced Renal Disorder Date:12/12/05ISR Number: 4851055-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040907979 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Risperdal PS ORAL Initial or Prolonged Blood Creatine Risperdal SS ORAL Phosphokinase Increased Risperdal SS ORAL Blood Creatinine Risperdal SS ORAL Increased Risperdal SS ORAL Blood Urea Increased Risperdal SS ORAL C-Reactive Protein Sodium Valproate C ORAL Increased Brotizolam C ORAL Dehydration Biperiden Nausea Hydrochloride C ORAL Poriomania Levomepromazine Pyelonephritis Maleate C ORAL Schizophrenia Lorazepam C ORAL Somatoform Disorder Lorazepam C ORAL Urinary Tract Infection Lorazepam C ORAL Metoclopramide C ORAL Levofloxacin C ORAL Haloperidol C 22-Feb-2006 08:20 AM Page: 2775 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/12/05ISR Number: 4851062-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103898 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Convulsion Haldol PS ORAL General Symptom Risperdal SS ORAL Date:12/12/05ISR Number: 4851100-3Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20051200311 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperkalaemia Risperdal PS ORAL Tramadol C Unspecified Medications C Magnesium C Warfarin C Amilodipine C Coloxyl C Transderm-Nitro C Paracetamol C Caltrate C Keflex C Valium C Pantoprazole C Date:12/12/05ISR Number: 4852092-3Report Type:Direct Company Report #CTU 264865 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bedridden Risperdal 2 Mg Other Drug Dispensing Error Janssen PS Janssen ORAL 2 MG ONCE A Required Feeling Abnormal DAY AT NIGH Intervention to Impaired Driving Ability PO Prevent Permanent Loss Of Employment Impairment/Damage Pharmaceutical Product Complaint Date:12/12/05ISR Number: 4852800-1Report Type:Direct Company Report #CTU 264832 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Drug Overdose Divalproex Ec PS ORAL 750MG Q12H Initial or Prolonged Intentional PO 2 MON Suicidal Ideation Risperidone SS ORAL 2MG BID PO 2 MON Date:12/13/05ISR Number: 4852389-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051200989 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Medication Error Risperdal PS ORAL Initial or Prolonged Muscle Necrosis Risperdal SS ORAL Shock Promethazine Hydrochloride SS ORAL Brotizolam SS ORAL 22-Feb-2006 08:20 AM Page: 2776 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/05ISR Number: 4852390-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051202042 Age:71 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS Date:12/13/05ISR Number: 4854277-9Report Type:Expedited (15-DaCompany Report #MK200512-0147-1 Age:14 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Literature Fluoxetine Capsules PS ORAL PO Multiple Drug Overdose Health Risperidone And Intentional Professional Other Unspecified Substances (Strengths, Doses And Therapy Dates SS Olanzapine SS Date:12/13/05ISR Number: 4854284-6Report Type:Direct Company Report #CTU 264963 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cholecystitis Risperidone PS ORAL 4 MG PO Initial or Prolonged Neutropenia Date:12/14/05ISR Number: 4853533-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051201007 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blindness Risperdal Consta PS INTRAMUSCULAR duration of Neuropathy 2-3 years Date:12/14/05ISR Number: 4853535-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051201143 Age:31 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Arrhythmia Risperdal PS ORAL Date:12/14/05ISR Number: 4853540-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051201975 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Weight Increased Risperdal PS ORAL Topamax SS ORAL Tavor C UNKNOWN Date:12/14/05ISR Number: 4853545-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051106285 Age:44 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal PS ORAL Iron Deficiency Anaemia Mosapride Citrate C ORAL Metrorrhagia Etizolam C ORAL 22-Feb-2006 08:20 AM Page: 2777 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/05ISR Number: 4854843-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908135 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Risperdal PS Initial or Prolonged Gastric Disorder Risperdal SS Other Gastrointestinal Disorder Risperdal SS Nephrolithiasis Risperdal SS Pain Clonidine C UNKNOWN Pancreatitis Diltiazem Er C UNKNOWN Sinus Tachycardia Amaryl C UNKNOWN Urinary Tract Infection Zyrtec C UNKNOWN as needed Allegra C UNKNOWN Date:12/15/05ISR Number: 4854845-4Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20051201338 Age:35 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Risperdal Consta PS INTRAMUSCULAR Hypotension Risperdal SS UNKNOWN 30 DAY Date:12/15/05ISR Number: 4854846-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051005783 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Activated Partial Risperdal PS ORAL 1 mg strength Initial or Prolonged Thromboplastin Time Risperdal SS ORAL Other Prolonged Abilify SS ORAL 15mg strength Blood Bicarbonate Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Blood Ph Increased Blood Thrombin Increased Bone Pain C-Reactive Protein Increased Disorientation Drug Toxicity Haematoma Osteonecrosis Pain In Extremity Rhabdomyolysis Somnolence Suicide Attempt Tachycardia Wolff-Parkinson-White Syndrome Date:12/15/05ISR Number: 4854847-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051201598 Age:82 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Respiratory Depression Risperdal PS ORAL 22-Feb-2006 08:20 AM Page: 2778 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/15/05ISR Number: 4854848-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051106294 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal Consta PS INTRAMUSCULAR Phosphokinase Increased Pyrexia Date:12/15/05ISR Number: 4854849-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051100002 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Risperdal Consta PS INTRAMUSCULAR Hyperprolactinaemia Risperdal Consta SS INTRAMUSCULAR Nipple Neoplasm Risperdal Consta SS INTRAMUSCULAR Date:12/15/05ISR Number: 4854850-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051201616 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperthyroidism Risperdal PS ORAL Date:12/15/05ISR Number: 4854851-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051201623 Age:13 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Risperdal PS ORAL Date:12/15/05ISR Number: 4854853-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050804661 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cough Risperdal PS ORAL Other Thrombocytopenia Risperdal SS ORAL Cyanocobalmin C Levothyroxine C Human Insulin C 42 units am, 22 units pm Calcichew C 1 Dose = 1 Tab Procyclidine C Omeprazole C Fybogel C taken nocte Senna C taken nocte Date:12/15/05ISR Number: 4854861-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051202211 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Risperdal PS Initial or Prolonged 22-Feb-2006 08:20 AM Page: 2779 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/16/05ISR Number: 4855697-9Report Type:Expedited (15-DaCompany Report #FR-ROCHE-427893 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Convulsion Valium PS Roche ORAL Initial or Prolonged Risperdal SS INTRAMUSCULAR Inipomp SS ORAL Theralene SS ORAL Mepronizine SS ORAL Atarax SS ORAL Date:12/19/05ISR Number: 4860120-4Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20051202824 Age:26 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Heart Rate Decreased Risperidone PS Initial or Prolonged Hypotension Risperidone SS Loss Of Consciousness Overdose Respiratory Arrest Suicide Attempt Date:12/19/05ISR Number: 4860121-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051001244 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Risperdal PS ORAL Hospitalization - Dehydration Risperdal SS ORAL Initial or Prolonged Dizziness Risperdal SS ORAL Encephalitis Chlorpromazine-Prome Fall thazine SS Inadequate Diet Risperdal SS ORAL Neuroleptic Malignant Quetiapine Fumarate C ORAL Syndrome Quetiapine Fumarate C ORAL Open Wound Etizolam C ORAL Pneumonia Flunitrazepam C ORAL Triazolam C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Date:12/19/05ISR Number: 4860122-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051106647 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cardiac Arrest Risperdal PS ORAL Other Hypoxic Encephalopathy Risperdal SS ORAL Respiratory Arrest Clotiazepam SS ORAL Donepezil Hydrochloride C ORAL Furosemide C INTRAVENOUS Potassium Canrenoate C INTRAVENOUS 22-Feb-2006 08:20 AM Page: 2780 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/19/05ISR Number: 4862602-8Report Type:Direct Company Report #CTU 265298 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Discomfort Zyprexa Eli Initial or Prolonged Gastrooesophageal Reflux Lilly PS Eli Lilly ORAL 10 MG 1 /DAY Disability Disease PO (DATES Other Nausea OF Required Pancreatitis USE/DURATION: Intervention to Weight Increased 3 YEARS, Prevent Permanent Risperdal Impairment/Damage Janssen SS Janssen INTRAMUSCULAR 2 MG 2 /DAY IM Celexa C Date:12/19/05ISR Number: 4862641-7Report Type:Direct Company Report #CTU 265314 Age:63 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Body Temperature Risperidone 0.5 Mg PS ORAL 0.5 MG BID Hospitalization - Increased PO Initial or Prolonged Loss Of Consciousness Date:12/20/05ISR Number: 4861161-3Report Type:Expedited (15-DaCompany Report #2005AP05976 Age:30183 DYGender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dehydration Seroquel PS Zeneca Pneumonia Aspiration Pharmaceutical ORAL 32 DAY Seroquel SS Zeneca Pharmaceutical ORAL Gramalil SS ORAL 52 DAY Gramalil SS ORAL Risperdal SS ORAL 52 DAY Risperdal SS ORAL Myslee C ORAL 53 DAY Myslee C ORAL Date:12/20/05ISR Number: 4861444-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051202220 Age:87 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Miosis Risperdal SS ORAL Mianserin Hydrochloride SS ORAL Quetiapine Fumarate SS ORAL Hydroxyzine Pamoate C ORAL Date:12/21/05ISR Number: 4862586-2Report Type:Expedited (15-DaCompany Report #PHEH2005US13558 Age:28 YR Gender:Female I/FU:I Outcome PT Life-Threatening Constipation Other Cystitis Deafness Depression Diarrhoea 22-Feb-2006 08:20 AM Page: 2781 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dysphonia Gastrooesophageal Reflux Disease Report Source Product Role Manufacturer Route Dose Duration Hiatus Hernia Trileptal PS Novartis Sector: Hyperhidrosis Pharma ORAL 1000 mg BID Hypoaesthesia and 500 mg HS Kidney Infection Effexor SS Liver Disorder Mellaril SS Loss Of Consciousness Prozac SS Nasal Congestion Desipramine Oedema Peripheral Hydrochloride SS Oesophageal Ulcer Neurontin SS Haemorrhage Levoxyl SS Osteoporosis Risperdal SS Paraesthesia Depakene SS Rheumatoid Arthritis Wellbutrin SS Skin Laceration Lithium Carbonate SS Suicide Attempt Zyprexa SS Ulcer Thorazine SS Vision Blurred Klonopin SS Vomiting Clomipramine SS Weight Decreased Abilify SS Weight Increased Rocephin SS Yellow Skin Date:12/21/05ISR Number: 4862767-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051005272 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Fall Risperdal PS ORAL Hospitalization - Hypertension Risperdal SS ORAL Initial or Prolonged Multi-Organ Failure Tylenol Arthritis C Calcium D C Calcium D C Calcium D C Ativan C Niacin C ORAL Date:12/21/05ISR Number: 4862768-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050904628 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Renal Failure Acute Risperdal PS ORAL Hospitalization - Rhabdomyolysis Risperdal SS ORAL Initial or Prolonged Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Haloperidol SS ORAL Olanzapine SS ORAL Olanzapine SS ORAL Olanzapine SS ORAL Carbamazepine C ORAL Carbamazepine C ORAL 22-Feb-2006 08:20 AM Page: 2782 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Carbamazepine C ORAL Carbamazepine C ORAL Carbamazepine C ORAL Carbamazepine C ORAL Carbamazepine C ORAL Carbamazepine C ORAL Carbamazepine C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Diazepam C ORAL Diazepam C ORAL Diazepam C ORAL Nitrazepam C ORAL Nitrazepam C ORAL Zopiclone C ORAL Zopiclone C ORAL Lorazepam C ORAL Lorazepam C ORAL Loxoprofen Sodium C ORAL Loxoprofen Sodium C ORAL Rebamipide C ORAL Rebamipide C ORAL Date:12/21/05ISR Number: 4864404-5Report Type:Direct Company Report #CTU 265496 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Blood Prolactin Increased Risperidone PS ORAL 2MG PO Date:12/21/05ISR Number: 4865130-9Report Type:Direct Company Report #CTU 265473 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Localised Oedema Risperidone PS ONE DOSE Oedema Peripheral Gabapentin SS ONE DOSE Pharyngeal Oedema Depakote C Pruritus Klonopin C Swelling Face Date:12/21/05ISR Number: 4867063-0Report Type:Expedited (15-DaCompany Report #HQWYE084819DEC05 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Foreign Avlocardyl Health (Propranolol Professional Hydrochloride) PS ORAL 40 MG 1X PER Other 1 DAY ORAL Depakene (Valproate Sodium, ) SS ORAL 2 G 1X PER 1 DAY ORAL Risperdal (Risperidone, ) SS ORAL ORAL 22-Feb-2006 08:20 AM Page: 2783 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rivotril (Clonazepam, ) SS ORAL 8 MG 1X PER 1 DAY ORAL Date:12/22/05ISR Number: 4864453-7Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-12904058 Age:80 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypotension Moditen Depot PS Apothecon Initial or Prolonged Urinary Tract Infection Risperdal SS Date:12/22/05ISR Number: 4864473-2Report Type:Expedited (15-DaCompany Report #GB-BRISTOL-MYERS SQUIBB COMPANY-13047998 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hypertension Moditen Depot PS Apothecon Initial or Prolonged Urinary Tract Infection Risperdal SS The dose of Risperdal was decreased to 1 mg daily in the evening. Date:12/22/05ISR Number: 4864485-9Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051203522 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyslipidaemia Risperdal PS ORAL start date Initial or Prolonged reported as longer than 1 year Date:12/22/05ISR Number: 4864486-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051100022 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Delusion Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Hyperprolactinaemia Lexomil C UNKNOWN 1 tablet a Other Pituitary Tumour Benign day Date:12/22/05ISR Number: 4867214-8Report Type:Expedited (15-DaCompany Report #S05-USA-04433-01 Age:94 YR Gender:Male I/FU:F Outcome PT Hospitalization - Alanine Aminotransferase Initial or Prolonged Increased Aspartate Aminotransferase Increased Atrioventricular Block First Degree Blood Alkaline Phosphatase Increased Blood Bilirubin Increased Blood Glucose Increased Bundle Branch Block Left Carbon Dioxide Decreased 22-Feb-2006 08:20 AM Page: 2784 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Cholelithiasis Creatine Phosphokinase Decreased Report Source Product Role Manufacturer Route Dose Duration Gait Disturbance Health Namenda (Memantine) PS ORAL 10 MG BID PO Gallbladder Disorder Professional Risperdal Haematocrit Decreased (Risperidone) SS ORAL 0.5 MG BID PO Lipase Increased Flomax (Tamsulosin) C Somnolence Aspirin C Tremor Alphagan Urinary Tract Infection (Brimonidine White Blood Cell Count Tratrate) C Increased Date:12/22/05ISR Number: 4867270-7Report Type:Expedited (15-DaCompany Report #MK200512-0266-1 Age:53 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Multiple Drug Overdose Literature Oxycodone Hcl Health Tablets (Strength Professional Unknown) PS ORAL PO Risperidone SS Mirtazapine SS Date:12/23/05ISR Number: 4867583-9Report Type:Direct Company Report #CTU 265626 Age:83 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Risperidone 1 Mg Janssen PS Janssen ORAL 1 MG TWICE DAILY PO Levoyhyroxine C Prilosec C Albuterol Mdi C Tylenol C Lorazepam C Haloperidol C Bisacodyl C Dss Liquid C Prochlorperazine C Date:12/23/05ISR Number: 4868614-2Report Type:Expedited (15-DaCompany Report #2005168783 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Literature Sertraline Initial or Prolonged Dyskinesia Health (Sertraline) PS Other Ear Pain Professional Haloperidol Flashback (Haloperidol) SS Joint Stiffness Risperidone Nightmare (Risperidone) SS Persecutory Delusion Olanzapine Suicidal Ideation (Olanzapine) SS 22-Feb-2006 08:20 AM Page: 2785 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/05ISR Number: 4868747-0Report Type:Expedited (15-DaCompany Report #2005168219 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Foreign Sertraline Bone Density Decreased Literature (Sertraline) PS 50 MG Pathological Fracture Alprazolam Rib Fracture (Alprazolam) SS 0.5 MG Lorazepam (Lorazepam) SS 2.5 MG AS NECESSARY Trazodone (Trazodone) SS 100 MG Risperidone (Risperidone) SS 2 MG Venlafaxine (Venlafaxine) SS 150 MG (75 MG 2 IN 1 D) Penfluridol (Penfluirdol) C Flupentixol (Flupentixol) C Melitracen (Melitracen) C Date:12/27/05ISR Number: 4866556-XReport Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051203538 Age:57 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyslipidaemia Impromen Decanoate PS INTRAMUSCULAR Initial or Prolonged Risperdal Consta SS INTRAMUSCULAR Date:12/27/05ISR Number: 4866557-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051204135 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Drug Ineffective Risperdal Consta SS INTRAMUSCULAR Risperdal C ORAL Date:12/27/05ISR Number: 4866643-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051204104 Age:52 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Paralysis Risperdal PS ORAL Initial or Prolonged Rhabdomyolysis Risperdal SS ORAL Nitrazepam C Sennoside C Date:12/27/05ISR Number: 4867855-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050905899 Age:57 YR Gender:Male I/FU:F Outcome PT Hospitalization - Bronchitis Initial or Prolonged Hypertension Hypotonia Loss Of Consciousness Malaise 22-Feb-2006 08:20 AM Page: 2786 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pallor Respiratory Distress Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Risperidone) Professional Tablets PS ORAL 1 MG, IN 1 DAY, ORAL Atarax (Hydroxyzine Hydrochloride) Tablets C Seropram (Citalopram Hydrobromide) C Forlax (Macrogol) C Tranxene (Clorazepate Dipotassium) C Tegretol (Carbamazepine) C Diantalvic (Aporex) Capsules C Levothyroxine (Levothyroxine ) C Augmentin (Clavulin) C Omix (Tamsulosin Hydrochloride) C Mepronizine (Mepronizine) C Date:12/27/05ISR Number: 4867856-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051204578 Age: Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Breast Cancer Foreign Risperdal Health (Risperidone) PS Professional Date:12/27/05ISR Number: 4867858-3Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20051204285 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Foreign Risperdal Initial or Prolonged Asthenia Health (Risperidone) Blood Pressure Systolic Professional Tablets PS ORAL 0.5 MG, 2 IN Increased 1 DAY, ORAL Cognitive Deterioration Sintrom Confusional State (Acenocoumarol) C Difficulty In Walking Disorientation Hallucination Vertigo Date:12/27/05ISR Number: 4867859-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051203929 Age: Gender:Unknown I/FU:I Outcome PT Other Blood Ph Decreased Caesarean Section Drug Exposure During 22-Feb-2006 08:20 AM Page: 2787 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pregnancy Neonatal Disorder Premature Baby Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Health (Risperidone) PS TRANSPLACENTAL 6 MG, Professional TRANSPLACENTA L Melperone (Melperone) SS TRANSPLACENTAL TRANSPLACENTA L Carbamazepine (Carbamazepine) SS TRANSPLACENTAL 1000 MG, TRANSPLACENTA L Date:12/27/05ISR Number: 4867867-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051203927 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Ph Decreased Foreign Risperdal Caesarean Section Health (Risperidone) PS TRANSPLACENTAL 6 MG, Drug Exposure During Professional TRANSPLACENTA Pregnancy L Neonatal Disorder Carbamazepine Premature Baby (Carbamazepine) SS TRANSPLACENTAL 1000 MG, TRANSPLACENTA L Melperone (Melperone) SS TRANSPLACENTAL TRANSPLACENTA L Femibion (All Other Therapeutic Products) C Date:12/27/05ISR Number: 4867868-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051204104 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bone Disorder Foreign Risperdal Rhabdomyoma Consumer (Risperidone) PS ORAL ORAL Date:12/27/05ISR Number: 4867874-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051002824 Age:57 YR Gender:Female I/FU:F Outcome PT Life-Threatening Ascites Hospitalization - Aspartate Initial or Prolonged Aminotransferase Disability Increased Blood Creatine Phosphokinase Increased Blood Lactate Dehydrogenase Increased Condition Aggravated Conversion Disorder Convulsion Depressed Level Of Consciousness 22-Feb-2006 08:20 AM Page: 2788 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disseminated Intravascular Coagulation Hallucination Report Source Product Role Manufacturer Route Dose Duration Hyperhidrosis Foreign Risperdal Hypernatraemia Health (Risperidone) PS ORAL SEE IMAGE Hypochondriasis Professional Zotepine (Zotepine) C Infection Haloperidol Muscle Rigidity (Haloperidol) C Myoglobinuria Lithium Carbonate Neuroleptic Malignant (Lithium Carbonate) C Syndrome Sodium Valproate Pyrexia (Valproate Sodium) C Respiratory Failure Phenytoin Urine Output Increased (Phenytoin) C Date:12/27/05ISR Number: 4867883-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051204158 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Risperdal Consta Drug Exposure Before Health (Risperidone) Pregnancy Professional Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Drug Exposure During WEEK, Pregnancy INTRA-MUSCULA R Date:12/27/05ISR Number: 4867884-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051003117 Age:58 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Foreign Risperdal Consta Radius Fracture Study (Risperidone) Health Microspheres PS INTRAMUSCULAR 50 MG, 1 IN 2 Professional WEEK, INTRA-MUSCULA R Date:12/27/05ISR Number: 4867885-6Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051203532 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Risperdal Consta Initial or Prolonged Increased Health (Risperidone) Dyslipidaemia Professional Micropheres PS ORAL 50 MG, 1 IN 2 WEEK, ORAL Date:12/27/05ISR Number: 4867886-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051101269 Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Foreign Risperdal Consta Initial or Prolonged Economic Problem Study (Risperidone) Hallucination Health Microspheres PS INTRAMUSCULAR 25 MG, Hallucination, Auditory Professional INTRAMUSCULAR Insomnia Risperidone Physical Assault (Risperidone) Tablets C 22-Feb-2006 08:20 AM Page: 2789 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Akineton (Biperiden Hydrochloride) Tablets C Eurodin (Estazola) Tablets C Date:12/27/05ISR Number: 4867893-5Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20051003399 Age:35 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Agranulocytosis Foreign Risperdal Life-Threatening Pneumonia Aspiration Health (Risperidone) Hospitalization - Professional Tablets PS ORAL 3 MG, 1 IN 1 Initial or Prolonged DAY, ORAL Baycip (Ciprofloxacin Hydrochloride) SS ORAL 1 G, 2 IN 1 DAY, ORAL Augmentine (Clavulin) SS INTRAVENOUS 3 G, 3 IN 1 DAY, INTRAVENOUS Aremis (Sertraline Hydrochloride) SS ORAL 50 MG, IN 1 DAY, ORAL Sinogan (Levomepromazine) SS ORAL 50 MG, IN 1 DAY, ORAL Rivotril (Clonazepam) SS ORAL 2 MG, IN 1 DAY, ORAL Opiren Flas (Lansoprazole) C Date:12/27/05ISR Number: 4867894-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051203784 Age:25 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Foreign Risperdal Health (Risperidone) PS ORAL ORAL Professional Date:12/27/05ISR Number: 4867895-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050300921 Age:77 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asthenia Foreign Risperdal Hospitalization - Breast Cancer Recurrent Health (Risperidone) PS ORAL 2 MG, IN 1 Initial or Prolonged Dysphagia Professional DAY, ORAL; 3 Lung Disorder MG, IN 1 DAY, Pneumonia Aspiration ORAL; 2 MG, IN 1 DAY, Haldol Decanoate (Haloperidol Decanoate) Injection C Furosemide (Furosemide) C 22-Feb-2006 08:20 AM Page: 2790 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/05ISR Number: 4867896-0Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051203519 Age:23 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) PS ORAL 4 MG, IN 1 Blood Triglycerides Professional DAY, ORAL Increased Zyprexa (Olanzapine) SS ORAL 20 MG, IN 1 Dyslipidaemia DAY, ORAL Date:12/27/05ISR Number: 4867897-2Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051203509 Age:25 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) PS ORAL 3 MG, ORAL Dyslipidaemia Professional Depakine (Valproate Sodium) SS 1500 MG Date:12/27/05ISR Number: 4867898-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051202712 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dyspnoea Foreign Risperdal Initial or Prolonged Nuchal Rigidity Health (Risperidone) PS ORAL 6 MG, 1 IN 1 Other Oculogyration Professional DAY, ORAL Overdose Company Throat Tightness Representative Date:12/27/05ISR Number: 4867899-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051202888 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Foreign Risperdal Initial or Prolonged Dyspnoea Health (Risperidone) Extrapyramidal Disorder Professional Tablets PS ORAL 2 MG, 2 IN 1 Lung Neoplasm DAY, ORAL; 1 MG, IN 1 DAY, ORAL Theralene (Alimemazine Tartrate) SS Corvasal (Molsidomine) C Nitriderm (Glyceryl Trinitrate) C Lasilix (Furosemide) C Diffu K (Potassium Chloride) C Pulmicort (Budesonide) C Previscan (Fluindione) C Bricanyl (Terbutaline Sulfate) C Atrovent (Ipratropium Bromide) C 22-Feb-2006 08:20 AM Page: 2791 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oxygen (Oxygen) C Orelox (Cefpodoxime Proxetil) C Date:12/27/05ISR Number: 4867900-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050402219 Age:37 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Foreign Risperdal Consta Drug Exposure During Study (Risperidone) Pregnancy Health Microspheres PS INTRAMUSCULAR 50 MG, 1 IN Pregnancy Professional 14 DAY, INTRA-MUSCULA R Risperidone (Risperidone) SS ORAL 6 MG, IN 1 DAY, ORAL; 4 MG IN 1 DAY, ORAL Insulin Actrapid (Insulin) Injection C Insulin Mixtard (Insulin Injection, Isophane) C Insulin Humalog (Insulin) Injection C Insulin Lantus (Insulin) C Diamicron (Gliclazide) Tablet C Date:12/27/05ISR Number: 4867965-5Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051203523 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) PS ORAL 4 MG, 1 IN Blood Triglycerides Professional DAY, ORAL Increased Dyslipidaemia Date:12/27/05ISR Number: 4867966-7Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051203521 Age:46 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) PS ORAL 4 MG, IN 1 Dyslipidaemia Professional DAY, ORAL Date:12/27/05ISR Number: 4867967-9Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051203520 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) PS ORAL 4 MG, IN 1 Dyslipidaemia Professional DAY, ORAL 22-Feb-2006 08:20 AM Page: 2792 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/27/05ISR Number: 4867968-0Report Type:Expedited (15-DaCompany Report #NO-JNJFOC-20051104201 Age:26 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Distension Foreign Risperdal Initial or Prolonged Abnormal Behaviour Consumer (Risperidone) PS ORAL 4 MG, IN 1 Amenorrhoea DAY, ORAL Blood Pressure Increased Cardiac Failure Cardiomegaly Cholecystectomy Congestive Cardiomyopathy Dyspnoea Ejection Fraction Decreased Flank Pain Fluid Retention Heart Rate Increased Hepatic Steatosis Hepatomegaly Intracardiac Thrombus Pericardial Effusion Pituitary-Dependent Cushing'S Syndrome Pollakiuria Pulmonary Hypertension Renal Scan Abnormal Respiratory Rate Increased Tricuspid Valve Incompetence Urinary Incontinence Ventricular Tachycardia Date:12/27/05ISR Number: 4867969-2Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051203525 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) PS ORAL 4 MG, ORAL Dyslipidaemia Professional Date:12/27/05ISR Number: 4867970-9Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051203524 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) PS ORAL 2 MG, IN 1 Blood Triglycerides Professional DAY, ORAL Increased Abilify Drug Interaction (Aripiprazole) SS ORAL 15 MG, IN 1 Dyslipidaemia DAY, ORAL Date:12/27/05ISR Number: 4867971-0Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050402219 Age:37 YR Gender:Female I/FU:F Outcome PT Other Abortion Spontaneous Drug Exposure During 22-Feb-2006 08:20 AM Page: 2793 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pregnancy Pregnancy Report Source Product Role Manufacturer Route Dose Duration Foreign Risperdal Consta Study (Risperidone) Health Microspheres PS INTRAMUSCULAR SEE IMAGE Professional Risperidone (Risperidone) Unspecified SS ORAL SEE IMAGE Insulin Actrapid (Insulin) Injection C Insulin Mixtyard (Insulin Injection, Isophane) C Insulin Humalog (Insulin) Injection C Insulin Lantus (Insulin) C Diamicron (Gliclazide) Tablet C . C Date:12/27/05ISR Number: 4867972-2Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051203534 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Haldol Decanoas Initial or Prolonged Increased Health (Haloperidol Dyslipidaemia Professional Decanoate) Injection PS INTRAMUSCULAR 100 MG, 1 IN 3 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) Unspecified SS ORAL 6 MG, 1 IN 24 HOUR, ORAL Date:12/27/05ISR Number: 4867974-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051201598 Age:82 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Back Pain Foreign Risperdal Initial or Prolonged Delirium Health (Risperidone) Incoherent Professional Solution PS ORAL 2 MG, IN 1 Pneumonia DAY, ORAL Respiratory Depression Benzbromarone Sedation (Benzbromarone) C Allopurinol (Allopurinol) C Losartan Potassium (Losartan Potassium) C Diltiazem Hydrochloride (Diltiazem Hydrochloride) C Furosemide (Furosemide) C Nizatidine (Nizatidine) C 22-Feb-2006 08:20 AM Page: 2794 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ethyl Icosapentate (Ethyl Icosapentate) C Beraprost Sodium (Beraprost Sodium) C Aspirin-Dialuminate (Bufferin) C Sodium Ferrous Citrate (Sodium Feredetate) C Loxoprofen Sodium (Loxoprofen Sodium) C Rebamipide (Rebamipide) C Date:12/27/05ISR Number: 4867980-1Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051203508 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Risperdal Initial or Prolonged Increased Health (Risperidone) PS ORAL 2 MG, ORAL Blood Triglycerides Professional Increased Dyslipidaemia Date:12/27/05ISR Number: 4868147-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050901270 Age:46 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Consumer Risperdal Initial or Prolonged Non-Insulin-Dependent Health (Risperidone) Tablet PS ORAL SEE IMAGE Other Gastric Ulcer Professional Glucophage Helicobacter Infection (Metformin Increased Appetite Hydrochloride) C Nausea Albuterol Weight Increased (Salbutamol) C Advair (Seretid Mite) C Loricet (Lorazepam) C Soma (Carisoprodol) C Tylenol (Acetaminophen) C Seroquel (Quetiapine Fumarate) C Date:12/27/05ISR Number: 4868153-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051103778 Age:65 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Coronary Artery Disease Consumer Risperdal Graft Thrombosis Health (Risperidone) Intracardiac Thrombus Professional Unspecified PS 0.5 MG, 3 IN Distributor 1 DAY Coumadin (Warfarin Sodium) C Imdur (Isosorbide Mononitrate) C Prevacid (Lansoprazole) C 22-Feb-2006 08:20 AM Page: 2795 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Reglan (Metoclopramide) C Prednisone (Prednisone) C Exelon (Rivastigmine Tartrate) C Ativan (Lorazepam) C Nephrovite (Nephro-Vite Rx) C Labetalol (Labetalol) C Catapress Patch (Clonidine) C Date:12/27/05ISR Number: 4868154-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051003631 Age:30 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Condition Aggravated Consumer Risperdal Consta Drug Ineffective (Risperidone) Dyspnoea Microspheres PS INTRAMUSCULAR INTRA-MUSCULA Fibromyalgia R Gingival Oedema Injection Site Pain Muscle Disorder Musculoskeletal Stiffness Pain Systemic Lupus Erythematosus Toothache Date:12/27/05ISR Number: 4869547-8Report Type:Expedited (15-DaCompany Report #BE-JNJFOC-20051203534 Age:44 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Cholesterol Foreign Haldol Decanoas Initial or Prolonged Increased Health (Haloperidol Dyslipidaemia Professional Decanoate) Injection PS INTRAMUSCULAR 100 MG, 1 IN 3 WEEK, INTRA-MUSCULA R Risperdal (Risperidone) SS ORAL 6 MG, 1 IN 24 HOUR, ORAL Date:12/27/05ISR Number: 4869630-7Report Type:Expedited (15-DaCompany Report #HQWYE662030OCT03 Age:34 YR Gender:Male I/FU:F Outcome PT Death Blood Pressure Decreased Hospitalization - Bronchopneumonia Initial or Prolonged Cardiac Arrest Cardiac Failure Chromaturia Completed Suicide Depressed Level Of Consciousness Electromechanical 22-Feb-2006 08:20 AM Page: 2796 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dissociation Glasgow Coma Scale Abnormal Grand Mal Convulsion Report Source Product Role Manufacturer Route Dose Duration Heart Rate Decreased Literature Effexor Xr Hepatic Congestion (Venlafaxine Hepatic Necrosis Hydrochloride, Hepatic Steatosis Tablet) PS ORAL OVERDOSE Hepatitis Acute AMOUNT Intentional Overdose UNKNOWN 1 DAY Multi-Organ Failure Chlorpromazine Nervousness (Chlorpromazine,) SS ORAL OVERDOSE Pulmonary Alveolar AMOUNT Haemorrhage UNKNOWN 1 DAY Pulmonary Congestion Risperidone Renal Failure Acute (Risperidone,) SS ORAL OVERDOSE Rhabdomyolysis AMOUNT UNKOWN 1 DAY Rib Fracture Serotonin Syndrome Sinus Tachycardia Date:12/27/05ISR Number: 4869633-2Report Type:Expedited (15-DaCompany Report #HQWYE112021DEC05 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Grand Mal Convulsion Health Inipomp Initial or Prolonged Professional (Pantoprazole, Other Tablet, Delayed Release) PS ORAL 40 MG 1X PER 1 DAY Atarax (Hydroxyzine Hydrochloride) SS ORAL 150 MG 1X PER 1 DAY Mepronizine (Aceprometazine/Mepr obamate) SS ORAL 410 MG 1X PER 1 DAY Risperdal (Risperidone) SS INTRAMUSCULAR Theralene (Alimemazine Tartrate) SS Valium (Diazepam) SS ORAL 15 MG 1X PER 1 DAY Date:12/27/05ISR Number: 4870136-XReport Type:Expedited (15-DaCompany Report #2005-136042-NL Age:45 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Mirtazapine PS ORAL DF, ORAL 1 DAY Drug Toxicity Mepromazine SS ORAL DF, ORAL 1 DAY Injury Asphyxiation Cyamemazine SS ORAL DF, ORAL Clomipramine Hydrochloride SS ORAL DF, ORAL 1 DAY Nordazepam SS ORAL DF, ORAL 1 DAY Risperidone SS ORAL DF, ORAL 22-Feb-2006 08:20 AM Page: 2797 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/05ISR Number: 4867762-0Report Type:Expedited (15-DaCompany Report #US-KINGPHARMUSA00001-K200501613 Age:32 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alopecia Levoxyl PS King Cough Pharmaceuticals, Dehydration Inc. ORAL Dizziness Abilify SS Dysphonia Wellbutrin SS 150 mg, tid Hearing Impaired Trileptal Hiatus Hernia "Ciba-Geigy" SS 2000 mg, UNK Lethargy Lithium SS 1200 mg, UNK Memory Impairment Zyprexa SS UNK, prn Nasal Congestion Thorazine SS UNK, prn Nephrolithiasis Clomipramine SS Osteoarthritis Risperidone SS Pyrexia Effexor SS Renal Disorder Prozac SS Renal Impairment Depakene SS Rheumatoid Arthritis Rhinorrhoea Sedation Somnolence Suicide Attempt Ulcer Unevaluable Event Vision Blurred Vomiting Weight Decreased Weight Increased Yellow Skin Date:12/29/05ISR Number: 4868048-0Report Type:Expedited (15-DaCompany Report #AU-ROCHE-429013 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drug Level Increased Clonazepam PS Roche INTRAMUSCULAR Respiratory Arrest Clopixol SS INTRAMUSCULAR DRUG NAME REPORTED AS CLOPIXOL- ACUPHASE. Risperidone SS UNKNOWN Date:12/29/05ISR Number: 4868167-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050904808 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Risperdal PS ORAL Initial or Prolonged First Degree Risperdal SS ORAL Other Electrocardiogram Qt Depakote C (500 mg every Prolonged morning and Rhabdomyolysis 1000 mg at bedtime) Diltiazem C Cocaine C 22-Feb-2006 08:20 AM Page: 2798 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/05ISR Number: 4868168-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050704504 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Risperdal PS ORAL Initial or Prolonged Diabetes Mellitus Medazepam SS ORAL Dizziness Flunitrazepam SS ORAL Drug Interaction Isosorbide Dinitrate C ORAL Fall Dipyridamole C ORAL Femoral Neck Fracture Digoxin C ORAL Gait Disturbance Furosemide C ORAL Hyperglycaemia Voglibose C ORAL Levomepromazine Maleate C ORAL Date:12/29/05ISR Number: 4868169-2Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051205059 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Agitation Risperdal Consta PS INTRAMUSCULAR 2 injections Anger given Anxiety Date:12/29/05ISR Number: 4868170-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051205135 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Risperdal PS ORAL Dose = Tablet Initial or Prolonged Hepatic Failure Motilyo SS ORAL Renal Failure Chronic Seropram SS ORAL Doliprane SS ORAL Xanax SS ORAL Lasilix C Oflocet C Aspegic C Date:12/29/05ISR Number: 4868171-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051203338 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Risperdal PS ORAL Hospitalization - Hyperammonaemia Dipiperon C ORAL Initial or Prolonged Hyponatraemia Dominal C Other Inappropriate Dominal C Antidiuretic Hormone Favistan C Secretion Pneumonia Aspiration Date:12/29/05ISR Number: 4868172-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051205141 Age:79 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Brain Oedema Risperdal PS ORAL 18 DAY Cerebral Haemorrhage Somnolence Thrombocytopenia 22-Feb-2006 08:20 AM Page: 2799 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/29/05ISR Number: 4868173-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040202537 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Erectile Dysfunction Risperdal PS ORAL patient took Initial or Prolonged Priapism only 1 dose Disability Skin Necrosis in total White Blood Cell Count Cylert C Increased Cylert C Klonopin C Propecia C Lexapro C Date:12/30/05ISR Number: 4869266-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051203784 Age:25 YR Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetic Ketoacidosis Risperdal PS ORAL Date:12/30/05ISR Number: 4869576-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051204628 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS Date:01/03/06ISR Number: 4870669-6Report Type:Periodic Company Report #BE-JNJFOC-20040604397 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Shoulder Pain Blinded; Galantamine PS ORAL 29 DAY Placebo SS ORAL 29 DAY Risperidone SS ORAL Asaflow C ORAL Geratam C ORAL Actonel C ORAL Date:01/03/06ISR Number: 4870699-4Report Type:Expedited (15-DaCompany Report #JP-JPN-A20053070 Age:64 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Paxil PS Glaxosmithkline ORAL Extrapyramidal Disorder Risperidone SS ORAL 2MG per day Somnolence Lorazepam C ORAL Zolpidem Tartrate C ORAL 10MG per day Amlodipine Besilate C ORAL 30MG per day Glimepiride C ORAL Metformin Hydrochloride C ORAL Date:01/03/06ISR Number: 4870732-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20051204281 Age: Gender:Male I/FU:F Outcome PT Death Abasia Agitation Dyskinesia Dyspnoea 22-Feb-2006 08:20 AM Page: 2800 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Heart Rate Increased Hypertension Muscle Contractions Report Source Product Role Manufacturer Route Dose Duration Involuntary Risperdal PS ORAL 2 DAY Pyrexia Diavan C Respiratory Arrest Artane C Date:01/03/06ISR Number: 4870733-1Report Type:Expedited (15-DaCompany Report #KR-JNJFOC-20051204825 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Risperidone PS Initial or Prolonged Risperidone SS (increased to 5 mg on hospital Day) Risperidone SS (increased to 2 mg on hospital Day 2) Gliclazide C 1 YR Amlodipine C 1 YR Carvedilol C 1 YR Acetyl-L-Carnitine C 10 MON Ticlopidine C 10 MON Date:01/03/06ISR Number: 4870734-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051205070 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accommodation Disorder Risperdal PS ORAL Visual Field Defect Date:01/03/06ISR Number: 4870735-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051205151 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Difficulty In Walking Risperdal Consta PS INTRAMUSCULAR Disorientation Dissociation Dysarthria Dysstasia Fatigue Incoherent Date:01/03/06ISR Number: 4870736-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051205298 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Risperdal PS ORAL Initial or Prolonged Risperdal SS ORAL Haloperidol C 22-Feb-2006 08:20 AM Page: 2801 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/06ISR Number: 4870737-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051205377 Age:62 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acidosis Risperdal PS Shock Unspecified Drug SS Date:01/03/06ISR Number: 4870738-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051102497 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal PS ORAL Initial or Prolonged Neuroleptic Malignant Risperdal SS ORAL Disability Syndrome Haloperidol I INTRAMUSCULAR Biperiden Hydrochloride I ORAL Biperiden Hydrochloride I ORAL Fluphenazine Decanoate I INTRAMUSCULAR Chlorpromazine Hydrochloride/Promet hazine Hydrochloride/Phenob arbital I ORAL Levomepromazine Maleate I ORAL Olanzapine I ORAL Quetiapine Fumarate I ORAL Date:01/03/06ISR Number: 4870739-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051205693 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Fall Risperdal PS ORAL Stevens-Johnson Syndrome Risperdal SS ORAL Carbamazepine SS ORAL Olanzapine C Date:01/03/06ISR Number: 4871016-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051205339 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Risperdal PS ORAL Initial or Prolonged Corrected Interval Other Prolonged Date:01/03/06ISR Number: 4871017-8Report Type:Periodic Company Report #US-JNJFOC-20051105079 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Risperdal Consta PS OTHER given on Platelet Count Decreased 28-Nov (year unspecified) 22-Feb-2006 08:20 AM Page: 2802 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/03/06ISR Number: 4871018-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050902908 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Risperdal PS ORAL 1 AM and 1 PM Death Risperdal SS ORAL Hypertrophy Breast Zoloft C ORAL Norvasc C Asa C ORAL Ambien C once daily as needed Date:01/03/06ISR Number: 4871019-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051101432 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal PS ORAL Klonopin C ORAL Cogentin C (taken as 2 mg in the morning, 1 mg at noon, and 2 mg at Date:01/03/06ISR Number: 4872183-0Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20051205232 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Exposure During Foreign Risperdal Consta Initial or Prolonged Pregnancy Health (Risperidone) Maternal Condition Professional Microspheres PS TRANSPLACENTAL 25 MG Affecting Foetus TRANSPLACENTA Neonatal Respiratory Haloperidol Distress Syndrome (Tablets) Small For Dates Baby Haloperidol C Date:01/04/06ISR Number: 4871626-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051103963 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dystonia Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Date:01/04/06ISR Number: 4871631-XReport Type:Expedited (15-DaCompany Report #PHNU2005DE02371 Age:40 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aspartate Leponex / Clozaril Initial or Prolonged Aminotransferase (Clozapine) PS Novartis Sector: Increased Pharma ORAL up to 500 Blood Creatine mg/day Phosphokinase Increased Leponex / Clozaril Drug Interaction (Clozapine) SS Novartis Sector: Rhabdomyolysis Pharma ORAL up to 625 mg/day Leponex / Clozaril (Clozapine) SS Novartis Sector: Pharma ORAL up to 550 22-Feb-2006 08:20 AM Page: 2803 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report mg/day 2880 MIN Risperdal SS ORAL 4 mg, QD Orfiril C ORAL 1500 mg/day Resonium A C ORAL 45 g/day Date:01/04/06ISR Number: 4871648-5Report Type:Expedited (15-DaCompany Report #JP-SOLVAY-00305004308 Age:0 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Drug Exposure During Luvox 25 PS TRANSPLACENTAL Daily dose: Pregnancy 50 Drug Withdrawal Syndrome milligram(s) Neonatal Artane SS TRANSPLACENTAL Daily dose: 4 Eye Movement Disorder milligram(s) Hypotonia Rivotril SS TRANSPLACENTAL Daily dose: 1 Irritability milligram(s) Pyrexia Seroquel SS TRANSPLACENTAL Daily dose: Somnolence 75 Tremor milligram(s) Hiberna SS TRANSPLACENTAL Daily dose: 75 milligram(s) Silece SS TRANSPLACENTAL Daily dose: 4 milligram(s) Risperdal SS TRANSPLACENTAL Daily dose: 4 milligram(s) Date:01/04/06ISR Number: 4871897-6Report Type:Expedited (15-DaCompany Report #PHEH2005US13558 Age:28 YR Gender:Female I/FU:F Outcome PT Life-Threatening Alopecia Other Constipation Cough Cystitis Deafness Dehydration Depression Diabetes Mellitus Diarrhoea Dizziness Dysphonia Gastrooesophageal Reflux Disease Hearing Impaired Hiatus Hernia Hyperhidrosis Hypersomnia Hypoaesthesia Kidney Infection Lethargy Liver Disorder Loss Of Consciousness Memory Impairment Nasal Congestion Nephrolithiasis Oedema Peripheral Oesophageal Ulcer Haemorrhage Osteoarthritis 22-Feb-2006 08:20 AM Page: 2804 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Osteoporosis Paraesthesia Pyrexia Report Source Product Role Manufacturer Route Dose Duration Renal Impairment Trileptal PS Novartis Sector: Rheumatoid Arthritis Pharma ORAL 1000 mg BID Rhinorrhoea and 500 mg HS Sedation Effexor SS Suicide Attempt Mellaril SS Ulcer Prozac SS Vision Blurred Desipramine Vomiting Hydrochloride SS Weight Decreased Neurontin SS Weight Increased Levoxyl SS Yellow Skin Risperdal SS Depakene SS Wellbutrin SS Lithium Carbonate SS Zyprexa SS Thorazine SS Klonopin SS Clomipramine SS Abilify SS Rocephin SS Date:01/04/06ISR Number: 4874092-XReport Type:Expedited (15-DaCompany Report #2005172168 Age:47 YR Gender:Unknown I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alopecia Consumer Lipitor Initial or Prolonged Blood Cholesterol (Atorvastatin) PS (1 IN 1D) Other Increased Risperdal Cerebrovascular Accident (Risperidone) SS 20 MG Cholelithiasis Hernia Hypotrichosis Nausea Skin Disorder Vomiting Date:01/04/06ISR Number: 4874507-7Report Type:Direct Company Report #CTU 266208 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Risperdal 0.5 Mg PS ORAL 0.5 MG HS PO Date:01/05/06ISR Number: 4873016-9Report Type:Expedited (15-DaCompany Report #KR-JNJFOC-20051204825 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agranulocytosis Risperidone PS Initial or Prolonged Risperidone SS (increased to 5 mg on hospital Day 9) Risperidone SS (increased to 2 mg on hospital Day 2) 22-Feb-2006 08:20 AM Page: 2805 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gliclazide C 1 YR Amlodipine C 1 YR Carvedilol C 1 YR Acetyl-L-Carnitine C 10 MON Ticlopidine C 10 MON Date:01/05/06ISR Number: 4873419-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20060100235 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Risperdal PS Initial or Prolonged Date:01/05/06ISR Number: 4873420-9Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20041206151 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Risperdal PS ORAL (3 mg tablet; Initial or Prolonged Insulin-Dependent 1.5 tablets Other Diabetic Ketoacidosis daily) Muscle Rigidity Risperdal SS ORAL Risperdal SS ORAL (1 mg tablet; one-half tablet twice daily) Risperdal SS ORAL Risperdal SS ORAL Luvox C ORAL (100 mg tablet; one tablet in morning and 0.5 tablet at Paxil C ORAL (started at 10 mg in approximately Nov-97) Paxil C ORAL (20 mg tablet; 3 tablets every morning) Paxil C ORAL Klonopin C ORAL (1.5 pills twice daily) Klonopin C ORAL (1 mg tablet; 1.5 tablets twice daily) Date:01/05/06ISR Number: 4875572-3Report Type:Expedited (15-DaCompany Report #S05-FRA-05767-01 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Seropram (Citalopram Initial or Prolonged Hepatic Failure Health Hydrobromide) PS 2 UNK QD Professional Risperdal Other (Risperidone) SS 2 Doliprane (Paracetamol) SS 4 G QD Xanax (Alprazolam) SS 22-Feb-2006 08:20 AM Page: 2806 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oflocet (Ofloxacin) C Lasilix (Furosemide) C Aspegic (Acetylsalicylate Lysine) C Date:01/06/06ISR Number: 4873934-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051205785 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bundle Branch Block Right Risperdal PS ORAL Date:01/06/06ISR Number: 4873936-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103896 Age:48 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Risperdal PS ORAL Drug Interaction Risperdal SS ORAL 5-0mg Extrapyramidal Disorder Dominal C ORAL Muscle Rigidity Akineton C Maximum dose Parkinsonism of 8mg daily Dominal C ORAL Cipramil I ORAL Date:01/06/06ISR Number: 4873937-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050704712 Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Murmur Risperdal PS TRANSPLACENTAL For the first Initial or Prolonged Premature Baby 11 weeks of Disability Pyelectasia amenorrhea Congenital Anomaly Deroxat SS TRANSPLACENTAL Date:01/06/06ISR Number: 4873938-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060100017 Age:14 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eosinophilia Risperdal PS ORAL Date:01/06/06ISR Number: 4873955-9Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20051201338 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Risperdal Consta PS INTRAMUSCULAR 16 DAY Cardiac Arrest Risperdal SS UNKNOWN 30 DAY Coma Hypotension Hypoxic Encephalopathy Date:01/06/06ISR Number: 4873956-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060100940 Age:50 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Multiple Sclerosis Risperdal Consta PS INTRAMUSCULAR 12 MON 22-Feb-2006 08:20 AM Page: 2807 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/06/06ISR Number: 4874126-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050606818 Age:17 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Interaction Haloperidol PS ORAL Muscle Spasms Haloperidol SS ORAL 5-10 mg as Oculogyration needed Oropharyngeal Spasm Haloperidol SS ORAL Haldol Decanoate SS INTRAMUSCULAR concentration : 50 mg/ml Risperdal SS ORAL Risperdal SS ORAL Risperdal SS ORAL patient received between 2 and 4 mg Haldol Decanoate SS INTRAMUSCULAR concentration : 50 mg/ml Haloperidol SS ORAL Tegretal C ORAL Akineton C ORAL Eunerpan I ORAL Date:01/06/06ISR Number: 4874134-1Report Type:Expedited (15-DaCompany Report #US-GLAXOSMITHKLINE-A0559419A Age:8 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Paxil PS Glaxosmithkline ORAL Initial or Prolonged Agitation Zoloft SS ORAL 25MG Unknown Other Anxiety Risperdal SS UNKNOWN Insomnia Murder Personality Change Psychomotor Hyperactivity School Refusal Suicidal Ideation Date:01/06/06ISR Number: 4874181-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051101653 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Caesarean Section Risperdal PS Crying Lorazepam SS Drug Exposure During Pregnancy Drug Withdrawal Syndrome Neonatal Feeding Disorder Neonatal Irritability Neonatal Disorder Urine Output Decreased Date:01/06/06ISR Number: 4874182-1Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20050805265 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Precocious Puberty Risperdal PS ORAL Risperdal SS ORAL Carbamazepine C 22-Feb-2006 08:20 AM Page: 2808 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Melatonin C At night. Date:01/06/06ISR Number: 4874471-0Report Type:Expedited (15-DaCompany Report #FR-ROCHE-429990 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Epilepsy Rivotril PS Roche ORAL 21 DAY Initial or Prolonged Hyponatraemia Avodart SS ORAL 5 DAY Cardensiel SS ORAL 21 DAY Risperdal SS ORAL 21 DAY Vivalan SS ORAL 21 DAY Duphalac C Aranesp C Imovane C Zyloric 100 C Lasilix 40 C Lodales C Kardegic C Omix C Triflucan C Date:01/09/06ISR Number: 4874824-0Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0320790-00 Age:57 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Depakine Chrono Tablets PS ORAL Clonazepam SS ORAL Propranolol SS ORAL Risperidone SS Haloperidol C 3 DAY Loxapine Succinate C 3 DAY Date:01/09/06ISR Number: 4875675-3Report Type:Periodic Company Report #DE-JNJFOC-20051104509 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Creatine Risperdal Consta PS INTRAMUSCULAR Phosphokinase Increased Risperdal Consta SS INTRAMUSCULAR Extrapyramidal Disorder Tavor C ORAL Neuroleptic Malignant Tavor C ORAL Syndrome Tavor C ORAL Pyrexia Date:01/09/06ISR Number: 4875678-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051103880 Age:70 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Cold Sweat Risperdal PS ORAL Dyspnoea Risperdal SS ORAL Hemiparesis Risperdal SS ORAL Risperdal SS ORAL Risperdal SS ORAL Delix C ORAL Metformin C ORAL Insulin C 22-Feb-2006 08:20 AM Page: 2809 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/06ISR Number: 4875680-7Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20050606891 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Circulatory Collapse Risperdal Consta PS INTRAMUSCULAR Drug Interaction Risperdal Consta SS INTRAMUSCULAR Heart Rate Increased Dipiperon SS ORAL taken at 18.00hrs Dipiperon SS ORAL Dipiperon SS ORAL Olanzapine SS ORAL Laubeel I ORAL Laubeel I ORAL Laubeel I ORAL Date:01/09/06ISR Number: 4875681-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060100120 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Risperdal PS ORAL Initial or Prolonged Trimetazidine SS ORAL Amlor SS ORAL Deroxat SS ORAL Tanakan SS ORAL Trivastal SS ORAL Ephynal C Stresam C Mepronizine C Mepronizine C Relvene C Lectil C Date:01/09/06ISR Number: 4875682-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051201598 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pneumonia Risperdal PS ORAL Initial or Prolonged Respiratory Depression Risperdal SS ORAL Benzbromarone C ORAL Allopurinol C ORAL Losartan Potassium C ORAL Diltiazem Hydrochloride C ORAL Furosemide C ORAL Nizatidine C ORAL Ethyl Icosapentate C ORAL Beraprost Sodium C ORAL Aspirin-Dialuminate C ORAL Aspirin-Dialuminate C ORAL Aspirin-Dialuminate C ORAL Sodium Ferrous Citrate C ORAL Loxoprofen Sodium C ORAL Rebamipide C ORAL 22-Feb-2006 08:20 AM Page: 2810 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/09/06ISR Number: 4875683-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040104990 Age:16 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Muscle Hypertrophy Risperidone PS ORAL 36 MON Initial or Prolonged Risperidone SS ORAL 36 MON Risperidone SS ORAL 36 MON Haloperidol C ORAL Haloperidol C ORAL Haloperidol C ORAL Chlorpromazine Hydrochloride C ORAL Chlorpromazine Hydrochloride C ORAL Chlorpromazine Hydrochloride C ORAL Chlorpromazine Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Biperiden Hydrochloride C ORAL Mosapride Citrate C ORAL Mosapride Citrate C ORAL Mosapride Citrate C ORAL Date:01/10/06ISR Number: 4876189-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20031004734 Age:27 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Risperdal PS ORAL Pregnancy Deroxat C Premature Labour Premature Rupture Of Membranes Date:01/10/06ISR Number: 4876190-3Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060101251 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Risperdal Consta PS "2 lots of 25 Prolonged mg and 1 lot 37.5 mg" Risperdal SS ORAL Depixol SS Quetiapine SS Diuretics C Beta Blockers C Date:01/11/06ISR Number: 4877464-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040503235 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal Consta PS INTRAMUSCULAR Hospitalization - Depression Risperdal C ORAL Initial or Prolonged Psychotic Disorder Risperdal C ORAL Depakote C ORAL 22-Feb-2006 08:20 AM Page: 2811 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depakote C ORAL Depakote C ORAL Piportil C ORAL Piportil C ORAL Chlorpromazine C Oflocet C Oflocet C Piortil L4 C INTRAMUSCULAR Parkinane C Seropram C Xanax C Akineton C Stilnox C Date:01/11/06ISR Number: 4877465-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040506279 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Anxiety Risperdal C ORAL Suicidal Ideation Risperdal C ORAL Risperdal C ORAL Risperdal C ORAL Date:01/11/06ISR Number: 4877467-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051205339 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Risperdal PS ORAL Initial or Prolonged Corrected Interval Biperiden C Other Prolonged Date:01/11/06ISR Number: 4877663-XReport Type:Expedited (15-DaCompany Report #DK-JNJFOC-20060100144 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Anxiety Risperdal PS ORAL 9mg total Nervousness daily 6 YR Social Phobia Akiniton C UNKNOWN Tremor Truxal C UNKNOWN Weight Decreased Oxapax C UNKNOWN Date:01/11/06ISR Number: 4877664-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060100960 Age:80 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS ORAL Neutropenia Date:01/11/06ISR Number: 4878018-4Report Type:Expedited (15-DaCompany Report #2006AP00061 Age:87 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Quetiapine Fumarate PS Zeneca Other Miosis Pharmaceutical ORAL Risperdal SS ORAL 22-Feb-2006 08:20 AM Page: 2812 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal SS ORAL Mianserin Hydrochloride SS ORAL Hydroxyzine Pamoate C ORAL Date:01/12/06ISR Number: 4878706-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060100601 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hyponatraemia Risperdal PS ORAL dose = tablet 21 DAY Initial or Prolonged Status Epilepticus Rivotril SS ORAL 21 DAY Vivalan SS ORAL 21 DAY Cardensiel SS ORAL 21 DAY Avodart SS ORAL dose = capsule 5 DAY Lasilix C UNKNOWN Imovane C UNKNOWN Zyloric C UNKNOWN Lodales C UNKNOWN Kardegic C UNKNOWN Omix C UNKNOWN Triflucan C UNKNOWN Aranesp C UNKNOWN Duphalac C UNKNOWN Date:01/12/06ISR Number: 4878707-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060100604 Age:15 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apathy Risperdal PS ORAL Initial or Prolonged Clonus Sabril SS ORAL Convulsion Rivotril C Dysstasia Extrapyramidal Disorder Salivary Hypersecretion Somnolence Tachycardia Date:01/12/06ISR Number: 4878708-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060101197 Age:30 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aggression Risperdal Consta PS INTRAMUSCULAR Date:01/12/06ISR Number: 4878709-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060101214 Age:25 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Chest Pain Risperdal Consta PS INTRAMUSCULAR Patient had Death received 3 Pallor injections Xanax C 22-Feb-2006 08:20 AM Page: 2813 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/12/06ISR Number: 4878710-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060101660 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastric Ulcer Risperdal PS UNKNOWN Date:01/12/06ISR Number: 4878711-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060100667 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Risperdal PS UNKNOWN Prolonged Date:01/12/06ISR Number: 4878849-0Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0405868A Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Chloride Decreased Avodart PS Glaxosmithkline ORAL 1CAP Per day 5 DAY Initial or Prolonged Blood Creatine Increased Rivotril SS Other ORAL 20DROP per Coma day 21 DAY Csf Protein Increased Vivalan SS Other ORAL 300MG Twice Depressed Level Of per day 21 DAY Consciousness Risperdal SS Other ORAL 1UNIT per day 21 DAY Epilepsy Cardensiel SS Other ORAL 7.5MG Per day 21 DAY Grand Mal Convulsion Zyloric 100 C Glaxosmithkline ORAL Hyponatraemia Lasilix C Other ORAL 40MG Unknown Neutrophil Count Imovane C Other UNKNOWN Increased Lodales C Other UNKNOWN Troponin Increased Kardegic C Other UNKNOWN White Blood Cell Count Omix Lp 0.4 Mg C Other UNKNOWN Increased Triflucan 50 Mg C Other UNKNOWN Aranesp C Other UNKNOWN 60MG Cyclic Duphalac C Other UNKNOWN Date:01/12/06ISR Number: 4879124-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051106647 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Aspiration Risperdal PS ORAL Other Cardiac Arrest Risperdal SS ORAL Cyanosis Clotiazepam SS ORAL Hypoxic Encephalopathy Donepezil Malaise Hydrochloride C ORAL Respiratory Arrest Furosemide C INTRAVENOUS Potassium Canrenoate C INTRAVENOUS Date:01/12/06ISR Number: 4881942-XReport Type:Expedited (15-DaCompany Report #HQWYE874523MAY05 Age:57 YR Gender:Female I/FU:F Outcome PT Hospitalization - Balance Disorder Initial or Prolonged Blood Pressure Increased Other Dizziness Drug Interaction Heart Rate Increased Hyperhidrosis Insomnia Restlessness 22-Feb-2006 08:20 AM Page: 2814 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Serotonin Syndrome Tremor Vertigo Report Source Product Role Manufacturer Route Dose Duration Study Efexor (Venlafaxine Hydrochloride, Tablet) PS ORAL SEE IMAGE, ORAL 2 DAY Risperdal (Risperidone, ) SS 75 MG 1X PER 1 DAY, Saroten (Amitriptyline Hydrochloride, ) SS 50 MG 1X PER 1 DAY Date:01/12/06ISR Number: 4882037-1Report Type:Expedited (15-DaCompany Report #2006003907 Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Foreign Amlor (Amlodipine) PS ORAL 1 DOSE FORM Initial or Prolonged Health (1 IN 1 D), Professional ORAL Deroxat (Paroxetine Hydrochloride) SS ORAL 20 MG (20 MG, 1 IN 1 D), ORAL Trimetazidine (Trimetazidine) SS ORAL 3 DOSE FORMS (3 IN 1 D), ORAL Trivastal (Piribedil) SS ORAL 1 DOSE FORM (1 IN 1 D), ORAL Risperdal (Risperidone) SS ORAL 1.5 MG (1 IN 1 D), ORAL Tanakan (Ginkgo Biloba Extract) SS ORAL 120 MG (40 MG, TID), ORAL Ephynal (Tocopheryl Acetate) C Stresam (Etifoxine) C Meprobamate (Meprobamate) C Aceprometazine (Aceprometazine) C Relvene (Rutoside) C Lectil (Betahistine Hydrochloride) C Date:01/16/06ISR Number: 4881232-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060101205 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Disturbance In Attention Risperdal PS ORAL 135 DAY Initial or Prolonged Fall Ebixa SS ORAL 147 DAY Somnolence Aricept C UNKNOWN 22-Feb-2006 08:20 AM Page: 2815 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Seropram C UNKNOWN Lipanthyl C UNKNOWN Aldactone C UNKNOWN Date:01/16/06ISR Number: 4881522-6Report Type:Expedited (15-DaCompany Report #JP-GLAXOSMITHKLINE-B0360618A Age:66 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Akinesia Paxil PS Glaxosmithkline ORAL 32 WK Hospitalization - Blood Creatine Risperidone SS ORAL 2MG Per day 2 DAY Initial or Prolonged Phosphokinase Increased Luvox SS UNKNOWN 10 DAY Mutism Artane C ORAL 2MG Three Myoclonus times per day 14 WK Pain Solanax C ORAL .4MG Three Rhabdomyolysis times per day 21 WK Serotonin Syndrome Silece C UNKNOWN 2MG Per day 22 WK Stupor Laxoberon C ORAL 2.5MG Per day 21 WK Pursennid C ORAL 12MG Per day 21 WK Clonazepam C Date:01/16/06ISR Number: 4881539-1Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0405831A Age:84 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Fall Deroxat PS Glaxosmithkline ORAL 20MG Per day Initial or Prolonged Trimetazidine SS Other ORAL 1UNIT Three times per day Trivastal SS Other ORAL 1UNIT Per day Risperdal SS Other ORAL 1.5MG per day Amlor SS Other ORAL 1UNIT Per day Tanakan SS Other ORAL 40MG Three times per day Ephynal C Stresam C Mepronizine C Relvene C Lectil C Date:01/16/06ISR Number: 4881540-8Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0405839A Age:1 DY Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cardiac Murmur Deroxat PS Glaxosmithkline 20MG Per day Congenital Genitourinary Risperdal SS Other .5MG Twice Abnormality per day Drug Exposure During Pregnancy Date:01/16/06ISR Number: 4881541-XReport Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0405839B Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Exposure During Deroxat PS Glaxosmithkline ORAL 20MG Per day Pregnancy Risperdal SS Other UNKNOWN .5MG Twice Premature Rupture Of per day Membranes 22-Feb-2006 08:20 AM Page: 2816 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/16/06ISR Number: 4881683-9Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20051201338 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Risperdal Consta PS INTRAMUSCULAR 16 DAY Cardiac Arrest Risperdal SS UNKNOWN 30 DAY Coma Hypotension Hypoxic Encephalopathy Date:01/16/06ISR Number: 4881684-0Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20060101377 Age:24 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Risperdal Consta PS INTRAMUSCULAR Abnormal Leponex SS ORAL Sinus Tachycardia Date:01/16/06ISR Number: 4881685-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040907979 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Risperdal PS ORAL Initial or Prolonged Blood Creatine Risperdal SS ORAL Phosphokinase Increased Risperdal SS ORAL Blood Creatinine Risperdal SS ORAL Increased Risperdal SS ORAL Blood Urea Increased Risperdal SS ORAL Dehydration Sodium Valproate C ORAL Nausea Brotizolam C ORAL Poriomania Biperiden Pyelonephritis Hydrochloride C ORAL Schizophrenia Levomepromazine Maleate C ORAL Lorazepam C ORAL Lorazepam C ORAL Lorazepam C ORAL Metoclopramide C ORAL Levofloxacin C ORAL Haloperidol C Date:01/17/06ISR Number: 4885883-3Report Type:Expedited (15-DaCompany Report #2006004772 Age:32 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Multiple Drug Overdose Foreign Sertraline Initial or Prolonged Intentional Health (Sertraline) PS ORAL ORAL Suicide Attempt Professional Hydroxyzine Tachycardia Hydrochloride (Tablet) (Hydroxyzine Hydrochloride) SS ORAL 2500 MG (1 DOSE, ORAL Risperdal (Risperidone) SS ORAL 20 MG (1 MG, 1 DOSE), ORAL Ethanol (Ethanol) SS 22-Feb-2006 08:20 AM Page: 2817 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/17/06ISR Number: 4886200-5Report Type:Expedited (15-DaCompany Report #HQWYE874523MAY05 Age:57 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Balance Disorder Foreign Efexor Initial or Prolonged Blood Pressure Increased Study (Venlafaxine Other Dizziness Health Hydrochloride) PS ORAL 150 MG 1X PER Drug Interaction Professional 1 DAY; 75 MG Drug Interaction Other 1X PER 1 DAY 5 DAY Potentiation Risperdal Heart Rate Increased Hyperhidrosis (Risperdone) SS 1 MG 1X PER 1 Insomnia DAY Restlessness Saroten Serotonin Syndrome (Amitriptyline Tremor Hydrochloride,) SS 50 MG 1X PER Vertigo 1 DAY Date:01/18/06ISR Number: 4883122-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060101663 Age:34 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aspiration Risperdal PS Life-Threatening Blood Pressure Decreased Efexor SS ORAL Hospitalization - Cardiac Arrest Chlorpromazine SS Initial or Prolonged Cardiac Failure Chromaturia Completed Suicide Depressed Level Of Consciousness Heart Rate Decreased Hepatic Necrosis Multi-Organ Failure Overdose Renal Failure Acute Rib Fracture Serotonin Syndrome Sinus Tachycardia Date:01/18/06ISR Number: 4883197-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060100954 Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Asphyxia Risperdal PS ORAL Completed Suicide Norset SS ORAL Multiple Drug Overdose Mepronizine SS ORAL Intentional Mepronizine SS ORAL Tercian SS ORAL Anafranil SS ORAL Nordazepam SS ORAL Date:01/18/06ISR Number: 4883198-0Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20051003184 Age: Gender:Female I/FU:I Outcome PT Hospitalization - Contusion Initial or Prolonged Dizziness Drop Attacks Drug Interaction 22-Feb-2006 08:20 AM Page: 2818 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fall Haematoma Hypotension Report Source Product Role Manufacturer Route Dose Duration Somnolence Risperdal PS ORAL Risperdal SS ORAL Spasmo-Urgenin C Aspirin Protect C ORAL Dipiperon C ORAL Spasmo-Urgenin C Spasmo-Urgenin C Dipiperon I UNKNOWN Temesta I ORAL Temesta I ORAL Temesta I ORAL Temesta I ORAL Temesta I ORAL Date:01/18/06ISR Number: 4883199-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060101211 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Myocardial Infarction Risperdal Consta PS INTRAMUSCULAR Date:01/18/06ISR Number: 4883200-6Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060101265 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Acne Risperdal PS ORAL Initial or Prolonged Retinal Pigmentation Other Unspecified Sick Sinus Syndrome Antipsychotics C Truxal C UNKNOWN Date:01/18/06ISR Number: 4883201-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060101596 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Thyroid Function Test Risperdal PS UNKNOWN Abnormal Date:01/18/06ISR Number: 4883202-XReport Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060101664 Age:11 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS UNKNOWN Date:01/18/06ISR Number: 4883203-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060101935 Age:26 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polycythaemia Risperdal Consta PS INTRAMUSCULAR 22-Feb-2006 08:20 AM Page: 2819 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/18/06ISR Number: 4883214-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20040200183 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Automatism Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Delusion Risperdal Consta SS INTRAMUSCULAR Extrapyramidal Disorder Risperidone C ORAL Gamma-Glutamyltransferase Risperidone C ORAL Increased Risperidone C ORAL Hallucination, Auditory Deroxat C UNKNOWN Deroxat C UNKNOWN Deroxat C UNKNOWN Stilnox C UNKNOWN Lepticur C Sulfarlem C Date:01/18/06ISR Number: 4883362-0Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20051204109 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Cerebrovascular Accident Risperdal Consta PS INTRAMUSCULAR Metastases To Central Risperdal Consta SS INTRAMUSCULAR Nervous System Date:01/18/06ISR Number: 4883402-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051100002 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Akathisia Risperdal Consta PS INTRAMUSCULAR Hyperprolactinaemia Risperdal Consta SS INTRAMUSCULAR Nipple Neoplasm Risperdal Consta SS INTRAMUSCULAR Date:01/18/06ISR Number: 4883423-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060101625 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Hyperthermia Malignant Risperdal PS ORAL Date:01/18/06ISR Number: 4883424-8Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060101996 Age:33 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Polycythaemia Risperdal Consta PS INTRAMUSCULAR Date:01/18/06ISR Number: 4887487-5Report Type:Expedited (15-DaCompany Report #2006005938 Age:58 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Foreign Atarax (Tablet) Initial or Prolonged Drug Dependence Health (Hydroxyzine Professional Hydrochloride) PS ORAL 400 MG (DAILY), ORAL Neurontin (Gabapentin) SS ORAL 2400 MG (DAILY), ORAL Morphine (Morphine) SS ORAL 140 MG (DAILY), ORAL 22-Feb-2006 08:20 AM Page: 2820 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tramadol Hydrochloride (Tramadol Hydrochloride) SS ORAL 400 MG (DAILY), ORAL Noctran 10 (Acepromzaine, Acerometazine, Clorazepate Dipotassium) SS ORAL 2 "DF" (DAILY), ORAL Risperdal (Risperidone) SS 4 MG (DAILY) Norset (Mirtazapine) C Depamide (Valpromide) C Aldactone (Spironolactone) C Diffu K (Potassium Chloride) C Burinex (Bumetanide) C Tahor (Atorvastatin) C Allopurinol (Allopurinol) C Doliprane (Paracetamol) C Eupressyl (Urapidil) C Imovane (Zopiclone) C Date:01/18/06ISR Number: 4888114-3Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060100124 Age:28 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Foreign Risperdal Consta Initial or Prolonged Condition Aggravated Study (Risperidone) Delusion Health Microspheres PS INTRAMUSCULAR 50 MG, Professional INTRAMUSCULAR Other Nozinan (Levomepromazine) C Xanax (Alprazolam) C Date:01/19/06ISR Number: 4884989-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20060103307 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Granulocytopenia Risperdal Consta PS Date:01/20/06ISR Number: 4885852-3Report Type:Expedited (15-DaCompany Report #AU-JNJFOC-20050902626 Age:14 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diabetes Mellitus Risperdal PS ORAL Initial or Prolonged Insulin-Dependent Cipramil C Disability 22-Feb-2006 08:20 AM Page: 2821 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/20/06ISR Number: 4885853-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20060102830 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal PS Brain Neoplasm Galactorrhoea Date:01/20/06ISR Number: 4886184-XReport Type:Expedited (15-DaCompany Report #JNJPOC-20051004964 Age:50 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alcohol Use Fluticason PS Glaxosmithkline Fatigue Risperdal SS ORAL Suicide Attempt Ibuprofen SS Glaxosmithkline 600MG Single dose Saroten SS Glaxosmithkline 75MG Single dose Tegretal SS 200MG Single dose Alcohol SS Date:01/20/06ISR Number: 4886355-2Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050500070 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Upper Risperdal PS ORAL Initial or Prolonged Anxiety Risperdal SS ORAL Disability Appendicitis Risperdal SS ORAL Other Asthma Depakote C ORAL Back Pain Blood Alkaline Phosphatase Increased Blood Amylase Increased Blood Glucose Decreased Blood Urine Present Bronchitis Constipation Diabetes Mellitus Insulin-Dependent Diabetic Ketoacidosis Emotional Distress Hepatomegaly Loss Of Consciousness Major Depression Pain Pharyngitis Streptococcal Pneumonia Sinusitis Weight Decreased Date:01/20/06ISR Number: 4886483-1Report Type:Expedited (15-DaCompany Report #NSADSS2003005076 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrial Fibrillation Risperidone PS ORAL Initial or Prolonged Mental Status Changes Risperidone SS ORAL Risperdal SS 16 DAY Accupril C ORAL 22-Feb-2006 08:20 AM Page: 2822 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Detrol C ORAL Megace C ORAL Pravachol C ORAL Vitamin B12 C ORAL Diclofenac C ORAL Ambien C ORAL Multivitamins C ORAL Multivitamins C ORAL Multivitamins C ORAL Multivitamins C ORAL Multivitamins C ORAL Multivitamins C ORAL Multivitamins C ORAL Multivitamins C ORAL Norvasc C ORAL Date:01/20/06ISR Number: 4886835-XReport Type:Expedited (15-DaCompany Report #DE-ABBOTT-05P-062-0320827-00 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Activities Of Daily Ergenyl Tablets PS ORAL 30 DAY Other Living Impaired Ergenyl Tablets SS ORAL 30 DAY Affective Disorder Ergenyl Tablets SS ORAL 30 DAY Aggression Biperiden SS 1 DAY Confusional State Risperidone SS ORAL Delirium Risperidone SS ORAL Disorientation Mirtazapine C ORAL Drug Ineffective Venlafaxine C Extrapyramidal Disorder Venlafaxine C Fatigue Venlafaxine C Impulse-Control Disorder Venlafaxine C Mutism Psychomotor Hyperactivity Self Injurious Behaviour Somnolence Unevaluable Event Date:01/20/06ISR Number: 4889380-0Report Type:Expedited (15-DaCompany Report #2005168783 Age:54 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Agitation Literature Sertraline Initial or Prolonged Ear Pain Health (Sertraline) PS Other Flashback Professional Haloperidol Joint Stiffness (Haloperidol0 SS Nightmare Risperidone Persecutory Delusion (Risperidone) SS Suicidal Ideation Olanzapine Tardive Dyskinesia (Olanzapine) SS Tremor Benzatropine (Benzatropine) SS Aripiprazole (Aripiprazole) SS 22-Feb-2006 08:20 AM Page: 2823 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/20/06ISR Number: 4890055-2Report Type:Expedited (15-DaCompany Report #DSA_27612_2006 Age:85 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Foreign Tavor PS ORAL DF ONCE PO Initial or Prolonged Aspiration Health Risperdal SS ORAL DF ONCE PO Coma Professional Saroten "Bayer Hypotension Other Vital" SS ORAL DF ONCE PO Multiple Drug Overdose Alcohol SS ORAL DF ONCE PO Intentional Suicide Attempt Date:01/23/06ISR Number: 4887524-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050900447 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abasia Haldol PS ORAL Initial or Prolonged Aphasia Haldol SS ORAL (Dose: 0.5 mg Other Confusional State to 1 mg at Diarrhoea bedtime) Fall Risperdal SS ORAL Hallucination Celexa SS ORAL Muscle Rigidity Aricept C ORAL Normal Pressure Aricept C ORAL Hydrocephalus Lexapro C ORAL Somnolence Synthroid C ORAL Tardive Dyskinesia Lopressor C ORAL Vomiting Epogen C SUBCUTANEOUS (every Monday Weight Decreased and Friday) Protonix C ORAL Vitamin E C Promod C Ferrous Sulfate C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Date:01/23/06ISR Number: 4887537-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060102990 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Risperdal PS ORAL Initial or Prolonged Thrombocytopenic Purpura Date:01/23/06ISR Number: 4887541-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060102725 Age:8 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Attention Risperdal PS ORAL Initial or Prolonged Deficit/Hyperactivity Risperdal SS ORAL Disorder Precocious Puberty 22-Feb-2006 08:20 AM Page: 2824 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/23/06ISR Number: 4887546-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051205070 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Accommodation Disorder Risperdal PS ORAL 8 DAY Visual Field Defect Risperdal SS ORAL 8 DAY Date:01/23/06ISR Number: 4888333-6Report Type:Expedited (15-DaCompany Report #JP-JPN-A200600232 Age:53 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Diabetic Coma Paxil PS Glaxosmithkline Ketoacidosis Risperdal SS ORAL Pyrethia SS Glaxosmithkline UNKNOWN Silece SS UNKNOWN Sepazon SS ORAL Akineton SS UNKNOWN Gasmotin SS ORAL Meilax SS ORAL Date:01/23/06ISR Number: 4891072-9Report Type:Expedited (15-DaCompany Report #S05-FRA-05767-01 Age:92 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Foreign Seropram (Citalopram Initial or Prolonged Dyspnoea Health Hydrobromide) PS 2 QD Hepatic Failure Professional Risperdal Prothrombin Level Other (Risperidone) SS 2 Decreased Doliprane (Paracetamol) SS 4 G QD Xanax (Alprazolam) SS Aspegic (Acetysalicylate Lysine) SS Oflocet (Ofloxacin) C Lasilix (Furosemide) C Date:01/23/06ISR Number: 4892251-7Report Type:Expedited (15-DaCompany Report #2006005938 Age:58 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Foreign Neurontin Initial or Prolonged Drug Dependence Health (Gabapentin) PS ORAL 2400 MG Professional (DAILY), ORAL Atarax (Tablet) (Hydroxyzine Hydrochloride) SS ORAL 400 MG DAILY, ORAL Morphine (Morphine) SS ORAL 140 MG, DAILY, ORAL Tramadol Hydrochloride (Tramadol Hydrochloride) SS ORAL 400 MG DAILY, ORAL Noctran 10 (Acepromazine, Aceprometazine, Clorazepate 22-Feb-2006 08:20 AM Page: 2825 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dipotassium) SS ORAL 2 DF DAILY, ORAL Risperdal (Risperidone) SS 4 MG DAILY Norset (Mirtazapine) C Depamide (Valpromide) C Aldactone (Spironolactone) C Diffu-K (Potassium Chloride) C Burinex (Bumetanide) C Tahor (Atorvastatin) C Allopurinol (Allopurinol) C Dolioprane (Paracetamol) C Eupressyl (Urapidil) C Imovane (Zopiclone) C Date:01/24/06ISR Number: 4889283-1Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060102991 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pemphigoid Risperdal PS ORAL Initial or Prolonged Date:01/24/06ISR Number: 4889284-3Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051205339 Age:13 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electrocardiogram Qt Risperdal PS ORAL Initial or Prolonged Corrected Interval Risperdal SS ORAL Other Prolonged Biperiden C ORAL Date:01/24/06ISR Number: 4889550-1Report Type:Expedited (15-DaCompany Report #2006UW00985 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Diabetes Mellitus Seroquel PS Zeneca Other Neuroleptic Malignant Pharmaceutical ORAL Syndrome Risperdal SS Zyprexa SS Date:01/24/06ISR Number: 4889574-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050703599 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abortion Spontaneous Risperdal PS ORAL 2 x 4mg Initial or Prolonged Drug Exposure During tablets (8mg Other Pregnancy total) Metrorrhagia Lepticur C UNKNOWN Persecutory Delusion Depamide C UNKNOWN Heptamyl C UNKNOWN 22-Feb-2006 08:20 AM Page: 2826 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/24/06ISR Number: 4889578-1Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060101660 Age:38 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Gastric Ulcer Risperdal PS UNKNOWN Date:01/24/06ISR Number: 4893252-5Report Type:Expedited (15-DaCompany Report #2005-136042-NL Age:45 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Completed Suicide Foreign Mirtazapine PS ORAL DF, ORAL 1 DAY Drug Toxicity Health L Mepromazine - SS ORAL DF, ORAL 1 DAY Injury Asphyxiation Professional Cyamemazine SS ORAL DF, ORAL 1 DAY Other Clonipramine Hydrochloride SS ORAL DF, ORAL 1 DAY Nordazepam SS ORAL DF, ORAL 1 DAY Risperidone SS ORAL DF, ORAL 1 DAY Date:01/24/06ISR Number: 4893287-2Report Type:Expedited (15-DaCompany Report #6019545 Age:76 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Chloride Decreased Health Cardensiel 7.5 Mg Initial or Prolonged Blood Chloride Increased Professional (Tablet) (Bisoprolol Blood Creatinine Other Fumarate) PS ORAL 1 DOSAGE Increased FORMS (1 Creatinine Renal DOSAGE FORMS, Clearance Decreased 1 IN 1 D) 20 DAY Csf Protein Increased Rivotril Depressed Level Of (Clonazepam) SS ORAL 20 DAY Consciousness Vivalan (Viloxazine) SS ORAL 600 MG (300 Electroencephalogram MG, 2 IN 1 D) 20 DAY Abnormal Risperdal Epilepsy (Risperidone) SS ORAL 1 IN 1 D 20 DAY Grand Mal Convulsion Avodart Hyponatraemia (Dutasteride) SS ORAL 4 DAY Lumbar Puncture Abnormal Lasilix (Furosemide) C Tenderness Imovane (Zopiclone) C Troponin Increased Zyloric White Blood Cell Count (Allopurinol) C Increased Lodales (Simvastatin) C Kardegic (Acetylsalicylate Lysine) C Omix (Tamsulosin Hydrochloride) C Triflucan (Fluconazole) C Aranesp (Darbepoetin Alfa) C Duphalac (Lactulose) C Date:01/25/06ISR Number: 4890922-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20051106439 Age:80 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Cerebrovascular Accident Risperdal PS ORAL Dementia Alzheimer'S Type 22-Feb-2006 08:20 AM Page: 2827 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/25/06ISR Number: 4890923-1Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051205045 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchial Disorder Risperdal PS ORAL 19 DAY Initial or Prolonged Coma Tercian SS UNKNOWN 19 DAY Other Hyperthermia Lepticur SS UNKNOWN 19 DAY Hyponatraemia Imovane C Neuroleptic Malignant Sulfarlem C dose = tablet Syndrome Efferalgan C Rhabdomyolysis Vomiting Water Intoxication Date:01/25/06ISR Number: 4890924-3Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20051101120 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Risperdal Consta PS INTRAMUSCULAR Headache Seroxal C ORAL Swelling Face Date:01/25/06ISR Number: 4890925-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20051104206 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Disorder Risperdal Consta PS UNKNOWN Thrombosis Date:01/25/06ISR Number: 4890939-5Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060101664 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Leukopenia Risperdal PS UNKNOWN Neutropenia Risperdal SS UNKNOWN Date:01/25/06ISR Number: 4890946-2Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060104305 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Topalgic Lp PS ORAL Initial or Prolonged Drug Dependence Risperdal SS ORAL Imovane SS ORAL Skenan SS ORAL Atarax SS ORAL Depamide SS ORAL Noctran SS ORAL Noctran SS ORAL Noctran SS ORAL Norset (Mirtazapine) SS Neurontin SS ORAL Aldactone C UNKNOWN Diffu K C UNKNOWN Burinex C UNKNOWN Tahor C UNKNOWN Eupressyl C UNKNOWN Doliprane C UNKNOWN Allopurinol C UNKNOWN 22-Feb-2006 08:20 AM Page: 2828 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/25/06ISR Number: 4892253-0Report Type:Direct Company Report #CTU 267747 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Diabetes Mellitus Risperidone 3mg Non-Insulin-Dependent Jannsen PS Jannsen ORAL 6MG QHS PO Sertraline C Benztropine C Diphenhydramine C Date:01/25/06ISR Number: 4892687-4Report Type:Direct Company Report #CTU 267700 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Pressure Systolic Temazepam PS Initial or Prolonged Decreased Risperidone SS Electrocardiogram St Segment Depression Hypotension Ischaemia Lethargy Overdose Self Injurious Behaviour Date:01/26/06ISR Number: 4892187-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050500070 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Appendicitis Risperdal PS ORAL Initial or Prolonged Back Pain Risperdal SS ORAL Disability Bronchitis Risperdal SS ORAL Other Diabetes Mellitus Risperdal SS ORAL (1 mg daily Insulin-Dependent in morning; Diabetic Ketoacidosis 1.5 mg daily Hepatomegaly at bedtime) Major Depression Depakote C ORAL Pain Depakote C ORAL (250 mg twice Pharyngitis Streptococcal daily; 125 mg Pneumonia daily at Sinusitis bedtime) Date:01/26/06ISR Number: 4892298-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060104772 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Amnesia Risperdal Consta PS INTRAMUSCULAR Catatonia Risperdal Consta SS INTRAMUSCULAR Confusional State Date:01/26/06ISR Number: 4892538-8Report Type:Expedited (15-DaCompany Report #PHFR2006GB00569 Age:52 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Operation Carbamazepine PS Novartis Sector: Initial or Prolonged Intestinal Obstruction Pharma UNKNOWN Risperdal SS ORAL 4 mg, BID Paroxetine C UNKNOWN 22-Feb-2006 08:20 AM Page: 2829 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/06ISR Number: 4894751-2Report Type:Direct Company Report #CTU 267868 Age:49 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pancreatitis Necrotising Ezetimibe 10 Mg Initial or Prolonged Vomiting Merck/Schering-Ploug Disability h PS Merck/Schering-Ploug h ORAL 10 MG DAILY PO Risperidone 6 Mg Janssen SS Janssen ORAL 6 MG AT BEDTIME PO Date:01/26/06ISR Number: 4896253-6Report Type:Expedited (15-DaCompany Report #US016653 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Stevens-Johnson Syndrome Health Provigil PS ORAL 100 MG QD Initial or Prolonged Toxic Epidermal Professional ORAL Necrolysis Company Risperdal SS Representative Lexapro SS Date:01/26/06ISR Number: 4896449-3Report Type:Expedited (15-DaCompany Report #S05-USA-05393-01 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorgasmia Health Celexa (Citalopram Initial or Prolonged Encephalopathy Professional Hydrobromide) PS ORAL 40 MG QD PO Company Celexa (Citalopram Representative Hydrobromide) SS ORAL 60 MG QD PO Celexa (Citalopram Hydrobromide) SS ORAL 40 MG QD PO Celexa (Citalopram Hydrobromide) SS ORAL 20 MG QD PO Campral (Acamprosate Calcium) SS ORAL 666 MG TID PO Wellbutrin Sr (Bupropion) SS 150 MG QD Risperdal (Risperidone) SS 1 MG QHS Neurontin (Gabapentin) C Depakote (Valproate Semisodium) C Glyburide C Lactulose C Corgard (Nadolol) C Synthroid (Levothyroxine Sodium) C Caltrate (Calcium Carbonate) C Multivitamin C 22-Feb-2006 08:20 AM Page: 2830 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/06ISR Number: 4896764-3Report Type:Expedited (15-DaCompany Report #S06-FRA-00081-01 Age:90 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Increased Foreign Ebixa (Memantine) PS ORAL 10 MG QD PO Initial or Prolonged Disturbance In Attention Health Risperdal Fall Professional (Risperidone) SS ORAL 1 MG QD PO Somnolence Other Aricept (Donepezil Hydrochloride) C Seropram (Citalopram Hydrobromide) C Lipanthyl C Aldactone (Spironolactone) C Date:01/26/06ISR Number: 4896773-4Report Type:Expedited (15-DaCompany Report #2005134380 Age:47 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Arrhythmia Foreign Ziprasidone (Caps) Initial or Prolonged Extrapyramidal Disorder Consumer (Ziprasidone) PS ORAL 160 MG (80 Other Hypotension Health MG, 2 IN 1 Quadriparesis Professional D), ORAL Risperidone (Risperidone) SS Biperiden (Biperiden) C Diazepam (Diazepam) C Valproate Sodium (Valproate Sodium) C Date:01/27/06ISR Number: 4893507-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20050804902 Age:88 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bronchitis Risperdal PS ORAL 0.5 tablet Initial or Prolonged Haematoma daily (strength unknown). Nidrel C UNKNOWN Tegretol C UNKNOWN Triatec C UNKNOWN Minisintrom C UNKNOWN Minisintrom C UNKNOWN Date:01/27/06ISR Number: 4893508-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060103826 Age:54 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Risperdal PS ORAL 2 x 2mg (4mg total) 2 DAY Akineton Retard C UNKNOWN 2 DAY Urbanyl C UNKNOWN 1 YR Excelon C UNKNOWN 22-Feb-2006 08:20 AM Page: 2831 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/27/06ISR Number: 4893509-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060103843 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Foetal Disorder Risperdal PS TRANSPLACENTAL Quilonum C TRANSPLACENTAL tablets= dose Date:01/27/06ISR Number: 4893510-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060103856 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Oxygen Saturation Risperdal Consta PS Initial or Prolonged Decreased Respiratory Distress Date:01/27/06ISR Number: 4894470-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051101269 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Aggression Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Hallucination Risperidone C ORAL Hallucination, Auditory Risperidone C ORAL Insomnia Akineton C ORAL Eurodin C ORAL Eurodin C ORAL Lendormin-D C ORAL Vegetamin C ORAL Vegetamin C ORAL Vegetamin C ORAL Date:01/27/06ISR Number: 4894506-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060103817 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Risperdal PS ORAL Initial or Prolonged Depressed Level Of Consciousness Hypothermia Date:01/27/06ISR Number: 4894507-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20060104836 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal Consta PS INTRAMUSCULAR Decreased Depakote Er C ORAL Date:01/27/06ISR Number: 4894508-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060102991 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Pemphigoid Risperdal PS ORAL Initial or Prolonged Risperdal SS ORAL Quetiapine Fumarate C Levomepromazine Maleate C Flunitrazepam C Quazepam C 22-Feb-2006 08:20 AM Page: 2832 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Biperiden Hydrochloride C Sennoside C Date:01/30/06ISR Number: 4895011-6Report Type:Periodic Company Report #US-BRISTOL-MYERS SQUIBB COMPANY-13090600 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Drug Interaction Metformin Hcl PS Bristol-Myers Squibb Fungal Skin Infection Company ORAL Headache Risperdal I ORAL Prozac I Date:01/30/06ISR Number: 4895163-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051105494 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Overdose Risperdal PS ORAL Initial or Prolonged Respiratory Depression Risperdal SS ORAL Other Rhabdomyolysis Zyprexa SS ORAL Sinus Tachycardia Zyprexa SS ORAL Somnolence Suicide Attempt Vomiting Date:01/30/06ISR Number: 4895164-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051105757 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcoholism Risperdal PS UNKNOWN Initial or Prolonged Drug Abuser Alcoholic Beverage SS UNKNOWN Other Overdose Palpitations Syncope Date:01/30/06ISR Number: 4895165-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051001950 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acidosis Risperdal PS ORAL 10 tablets of Convulsion 1 mg Fatigue Citalopram SS ORAL 28 tablets of Overdose 20 mg = 560 Suicide Attempt mg Date:01/30/06ISR Number: 4895166-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051002555 Age:16 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Risperdal PS ORAL Initial or Prolonged Dysphagia Alcohol SS Extrapyramidal Disorder Gait Disturbance Hand Deformity Swollen Tongue Trismus 22-Feb-2006 08:20 AM Page: 2833 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/06ISR Number: 4895167-5Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060105034 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dysphonia Risperdal Consta PS INTRAMUSCULAR Laryngeal Cancer Carbamazepin C ORAL Date:01/30/06ISR Number: 4895168-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060105596 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Muscle Twitching Risperdal Consta PS INTRAMUSCULAR Tuberculosis Risperdal SS ORAL Risperdal SS ORAL Date:01/30/06ISR Number: 4895169-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060105605 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal Consta PS INTRAMUSCULAR Date:01/30/06ISR Number: 4895170-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060105639 Age:41 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Chest Pain Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Rhabdomyolysis Risperdal C Rivotril C Noctran C Noctran C Noctran C Date:01/30/06ISR Number: 4895180-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060103843 Age: Gender: I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Foetal Disorder Risperdal PS TRANSPLACENTAL Quilonum C TRANSPLACENTAL tablets= dose Date:01/30/06ISR Number: 4895181-XReport Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051000925 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Atrioventricular Block Risperdal PS ORAL Initial or Prolonged First Degree Dipiperon SS ORAL Other Blood Potassium Increased Amaryl SS ORAL Cardiac Arrest Durafenat SS ORAL dose = Diarrhoea capsule Dyspnoea Enalapril SS ORAL Metabolic Acidosis Tegretal SS ORAL Overdose Eunerpan SS UNKNOWN Pleural Effusion Suicide Attempt Vomiting 22-Feb-2006 08:20 AM Page: 2834 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/30/06ISR Number: 4895534-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20060104768 Age:3 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Murder Risperdal PS stopped Psychotic Disorder taking drug 2 days before murder Date:01/30/06ISR Number: 4897557-3Report Type:Direct Company Report #CTU 268131 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Extrapyramidal Disorder Risperdal PS ORAL 1 MG Q2H PO 1 DAY Gait Disturbance Speech Disorder Date:01/30/06ISR Number: 4899572-2Report Type:Expedited (15-DaCompany Report #2006-BP-00677RO Age:43 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Diarrhoea Foreign Lithium Carbonate Initial or Prolonged Hypernatraemia Literature (Lithium Carbonate) PS 1200 MG DAILY Nephrogenic Diabetes Health Risperidone Insipidus Professional (Risperidone) SS Obsessive-Compulsive Carbamazepine Disorder (Carbamazepine) SS Pain In Extremity Furosemide Pneumonia Aspiration (Furosemide) C Somnolence Amiloride (Amiloride) C Date:01/30/06ISR Number: 4899574-6Report Type:Expedited (15-DaCompany Report #2006-BP-00558RO Age:37 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anti-Gad Antibody Foreign Lithium Carbonate Initial or Prolonged Positive Literature (Lithium Carbonate) PS ORAL 900 MG/DAY, Anti-Islet Cell Antibody Health PO Positive Professional Risperidone Diabetes Mellitus (Risperidone) SS ORAL 2 TO 4 Diabetic Ketoacidosis MG/DAY, PO Metabolic Acidosis Valproate (Valproic Weight Increased Acid) C ORAL 2 GM/DAY, PO Date:01/31/06ISR Number: 4896303-7Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20060105082 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hospitalisation Risperdal PS Initial or Prolonged Weight Decreased Benzotropine C Promazine C 22-Feb-2006 08:20 AM Page: 2835 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/31/06ISR Number: 4896305-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060102990 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Risperdal PS ORAL Initial or Prolonged Thrombocytopenic Purpura Haloperidol C ORAL Date:01/31/06ISR Number: 4896307-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051204281 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Abasia Risperdal PS ORAL at bedtime Agitation (HS) 2 DAY Coordination Abnormal Diavan C Dyskinesia Artane C Dyspnoea Heart Rate Increased Hypertension Pyrexia Respiratory Arrest Date:01/31/06ISR Number: 4896308-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050804935 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abortion Spontaneous Risperdal PS UNKNOWN Drug Exposure During Pregnancy Drug Withdrawal Syndrome Date:01/31/06ISR Number: 4896619-4Report Type:Expedited (15-DaCompany Report #JP-SOLVAY-00305004308 Age:0 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Congenital Anomaly Drug Withdrawal Syndrome Luvox 25 PS TRANSPLACENTAL Daily dose: Neonatal 50 Eye Movement Disorder milligram(s) 5 MON Hypotonia Artane SS TRANSPLACENTAL Daily dose: 4 Irritability milligram(s) 5 MON Pyrexia Rivotril SS TRANSPLACENTAL Daily dose: 1 Somnolence milligram(s) 5 MON Tremor Seroquel SS TRANSPLACENTAL Daily dose: 75 milligram(s) 5 MON Hiberna SS TRANSPLACENTAL Daily dose: 75 milligram(s) 5 MON Silece SS TRANSPLACENTAL Daily dose: 4 milligram(s) 5 MON Risperdal SS TRANSPLACENTAL Daily dose: 4 milligram(s) 24 MON Date:01/31/06ISR Number: 4896684-4Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060103840 Age: Gender:Female I/FU:F Outcome PT Other Agitation Dyskinesia 22-Feb-2006 08:20 AM Page: 2836 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotension Oropharyngeal Spasm Overdose Report Source Product Role Manufacturer Route Dose Duration Suicidal Ideation Risperdal PS ORAL Tachycardia Date:01/31/06ISR Number: 4899307-3Report Type:Expedited (15-DaCompany Report #2005143131 Age:31 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Alcohol Use Foreign Atarax (Tablet) Initial or Prolonged Multiple Drug Overdose Health (Hydroxyzine Suicide Attempt Professional Hydrochloride) PS ORAL 2500 MG (ONE Tachycardia TIME INGESTION), ORAL Zoloft (Sertraline) SS ORAL ORAL Risperdal (Risperidone) SS ORAL ONE TIME INGESTION, ORAL Alcohol (Ethanol) SS ORAL ORAL Date:01/31/06ISR Number: 4899492-3Report Type:Expedited (15-DaCompany Report #A044-002-005930 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Pleurothotonus Foreign Aricept (Donepezil Intervention to Health Hydrochloride) PS ORAL 5 MG, 1 IN 1 Prevent Permanent Professional D, ORAL; SEE Impairment/Damage IMAGE Risperdal (Risperidone) SS ORAL 0.5 MG, 1 IN 1 D, ORAL; SEE IMAGE Dipiperon (Pipamperone) SS ORAL 20 MG, 1 IN 1 D, ORAL Date:02/01/06ISR Number: 4897625-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20060105372 Age:81 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Parkinson'S Disease Risperdal PS ORAL Date:02/01/06ISR Number: 4897626-8Report Type:Expedited (15-DaCompany Report #ES-JNJFOC-20060106006 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cerebral Haemorrhage Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Off Label Use Risperdal Consta SS INTRAMUSCULAR Other Amisulpride C 22-Feb-2006 08:20 AM Page: 2837 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/01/06ISR Number: 4897836-XReport Type:Expedited (15-DaCompany Report #S05-USA-05172-01 Age:50 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorgasmia Wellbutrin Sr PS Glaxosmithkline ORAL 150MG Per day Initial or Prolonged Drug Level Decreased Campral SS ORAL 666MG Three Encephalopathy times per day 46 DAY Celexa SS ORAL 20MG Per day Risperdal SS UNKNOWN 1MG At night Neurontin C 800MG Per day Depakote C 2000MG Per day Glyburide C Lactulose C Corgard C Synthroid C Glaxosmithkline Caltrate C Glaxosmithkline Multivitamin C Date:02/02/06ISR Number: 4899035-4Report Type:Expedited (15-DaCompany Report #AT-JNJFOC-20060104209 Age: Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Extrapyramidal Disorder Risperdal PS 0.5mg taken Fall in the Pneumonia morning and at night. Blopress C Concor C Zurcal C Aricept C Spasmolyt C Pancreoflat C Pancreoflat C Tolvon C Hydal C reported as 4mg/8mg Temesta C Thyrex C Protagent C Date:02/02/06ISR Number: 4899036-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20060105383 Age:75 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Mobility Decreased Risperdal M-Tabs PS ORAL Initial or Prolonged Speech Disorder Depakote C Weight Decreased Lithium C Prednisone C Cogentin C Date:02/02/06ISR Number: 4902030-XReport Type:Direct Company Report #CTU 268530 Age:60 YR Gender:Male I/FU:I Outcome Death Hospitalization - Initial or Prolonged Required 22-Feb-2006 08:20 AM Page: 2838 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Dose Duration Aggression Risperdal PS Depressed Level Of Zyprexa SS Consciousness Hypnagogic Hallucination Unevaluable Event Date:02/02/06ISR Number: 4902535-1Report Type:Expedited (15-DaCompany Report #2005-136338-NL Age:21 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Alanine Aminotransferase Foreign Mirtazapine PS ORAL 15 MG/DF 8 DAY Increased Health Risperidone SS ORAL 2MG/DF 27 DAY Blood Creatine Professional Procyclidine C Phosphokinase Mb Other Lorazepam C Increased C-Reactive Protein Increased Neuroleptic Malignant Syndrome Date:02/03/06ISR Number: 4900352-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060104122 Age:22 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Coma Paroxetine Initial or Prolonged Overdose Hydrochloride PS Glaxosmithkline ORAL 1 DAY Risperdal SS ORAL 1 DAY Etizolam SS ORAL 1 DAY Flunitrazepam SS ORAL 1 DAY Lorazepam SS ORAL 1 DAY Cloxazolam SS ORAL 1 DAY Nitrazepam SS ORAL 1 DAY Biperiden Hydrochloride SS ORAL 1 DAY Quazepam SS ORAL 1 DAY Date:02/03/06ISR Number: 4900407-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051205135 Age:92 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Failure Risperdal PS ORAL Dose = Tablet Initial or Prolonged Cytolytic Hepatitis Motilyo SS ORAL Hepatic Failure Seropram SS ORAL Renal Failure Chronic Doliprane SS ORAL Xanax SS ORAL Lasilix C Oflocet C Aspegic C 22-Feb-2006 08:20 AM Page: 2839 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/06ISR Number: 4900408-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051105994 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Nephrolithiasis Risperdal PS ORAL Initial or Prolonged Renal Colic Risperdal SS ORAL Other Date:02/03/06ISR Number: 4900409-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051101780 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Amniotic Cavity Infection Risperdal PS Initial or Prolonged Atrial Septal Defect Congenital Anomaly Caesarean Section Other Developmental Delay Drug Exposure During Pregnancy Foetal Growth Retardation Growth Retardation Hypertonia Leukopenia Malnutrition Mental Retardation Severity Unspecified Neonatal Respiratory Distress Syndrome Opisthotonus Patent Ductus Arteriosus Plagiocephaly Premature Baby Stress Temperature Regulation Disorder Vomiting Date:02/03/06ISR Number: 4900410-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050100373 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Hallucination, Auditory Risperdal PS ORAL Initial or Prolonged Herpes Zoster Risperdal SS ORAL Bifeprunox SS ORAL Bifeprunox SS ORAL Placebo SS ORAL Placebo SS ORAL Tarivid C UNKNOWN Femodene C UNKNOWN Femodene C UNKNOWN Daflon C UNKNOWN Nozid C UNKNOWN Corsodyl C UNKNOWN Akineton C UNKNOWN as needed with a max dose of twice daily Temesta C UNKNOWN as needed with a max dosage of 3mg /day. 22-Feb-2006 08:20 AM Page: 2840 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/03/06ISR Number: 4900411-1Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20060105651 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Abnormal Behaviour Risperdal PS ORAL Psychotic Disorder Methylphenidate C ORAL reported as Social Avoidant Behaviour 10mg, 1x20mg, 1x15mg Date:02/03/06ISR Number: 4900412-3Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060105708 Age:21 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Risperidone PS ORAL 2x2mg Dipiperon SS ORAL 2x40mg Doxepin SS ORAL 2x50mg Seroquel SS ORAL 1x100mg Date:02/03/06ISR Number: 4900413-5Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060103817 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Risperdal PS ORAL Initial or Prolonged Depressed Level Of Ivermectin C Other Consciousness Hypothermia Date:02/06/06ISR Number: 4902173-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060100667 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Risperdal PS UNKNOWN Prolonged Risperdal SS UNKNOWN Remergil C Zopiclone C Verapamil C Digimerck C Dynorm C Alna C Sinupret Forte C Sinupret Forte C Sinupret Forte C Sinupret Forte C Sinupret Forte C Sinupret Forte C dose = dragee Movigol C dose = pouch Date:02/06/06ISR Number: 4902174-2Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060105647 Age:31 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Leukopenia Risperdal PS ORAL Initial or Prolonged Risperdal SS ORAL Other Seroquel SS taken for several months 22-Feb-2006 08:20 AM Page: 2841 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/06ISR Number: 4902175-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060105894 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Risperdal PS ORAL Platelet Count Decreased Biperiden Hydrochloride C Chlorpromazine-Prome thazine Combined Drug C Flunitrazepam C Date:02/06/06ISR Number: 4903498-5Report Type:Direct Company Report #CTU 268656 Age:68 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Required Inadequate Diet Risperidone 1 Mg PS ORAL 1 MG PO QHS Intervention to Increased Insulin Prevent Permanent Requirement Impairment/Damage Treatment Noncompliance Weight Increased Date:02/07/06ISR Number: 4902709-XReport Type:Expedited (15-DaCompany Report #2006AP00409 Age:0 DY Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Apgar Score Low Seroquel PS Zeneca Initial or Prolonged Drug Withdrawal Syndrome Pharmaceutical TRANSPLACENTAL 5 MON Congenital Anomaly Neonatal Luvox SS TRANSPLACENTAL 5 MON Hypotonia Neonatal Artane SS TRANSPLACENTAL 5 MON Irritability Rivotril SS TRANSPLACENTAL 5 MON Somnolence Neonatal Hiberna SS TRANSPLACENTAL 5 MON Syncope Silece SS TRANSPLACENTAL 5 MON Risperdal SS TRANSPLACENTAL 24 MON Date:02/07/06ISR Number: 4902827-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060105707 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal PS ORAL Date:02/07/06ISR Number: 4902828-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20060106138 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Asthma Risperdal PS Epilepsy Tardive Dyskinesia Date:02/07/06ISR Number: 4902829-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20050801305 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Risperdal PS ORAL White Blood Cell Count Risperdal SS ORAL Decreased Fosamax C ORAL Synthroid C ORAL 22-Feb-2006 08:20 AM Page: 2842 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Synthroid C ORAL Arimidex C ORAL Paxil C ORAL Temazepam C Date:02/07/06ISR Number: 4902830-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060200310 Age:4 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal Consta PS INTRAMUSCULAR Breast Cancer Date:02/07/06ISR Number: 4902831-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051103220 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Dehydration Risperdal PS ORAL (1 mg Initial or Prolonged Diabetes Mellitus tablet): took Insulin-Dependent 0.5 tablet in Diabetic Ketoacidosis morning and Hypoglycaemia at 4 pm, and Inguinal Hernia Repair Risperdal SS ORAL Weight Decreased Risperdal SS ORAL White Blood Cell Count Methylphenidate C ORAL Increased Methylphenidate C ORAL Methylphenidate C ORAL Clonidine C ORAL (at bedtime) Clonidine C ORAL Paxil C ORAL (every morning) Paxil C ORAL Date:02/08/06ISR Number: 4903544-9Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060200018 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Anaemia Risperdal PS ORAL 4 DAY Cardiac Failure Acute Ramipril SS ORAL Liver Function Test Beloc Zok Mite SS ORAL Abnormal Zantic SS ORAL Protein Total Decreased Date:02/08/06ISR Number: 4903545-0Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060102990 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Risperdal PS ORAL Initial or Prolonged Thrombocytopenic Purpura Haloperidol C ORAL Date:02/08/06ISR Number: 4903546-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060201222 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Rhabdomyolysis Risperdal PS ORAL 22-Feb-2006 08:20 AM Page: 2843 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/06ISR Number: 4906350-4Report Type:Expedited (15-DaCompany Report #NZ-JNJFOC-20060105905 Age:2 YR Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Dispensing Error Risperdal PS ORAL Initial or Prolonged Eye Rolling Hypotonia Overdose Somnolence Tachycardia Date:02/09/06ISR Number: 4906351-6Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060200007 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Risperdal PS ORAL Initial or Prolonged Colitis Di-Antalvic C Intestinal Ischaemia Di-Antalvic C Insulin Humalog C Coversyl C Vasten C Mopral C Previscan C Date:02/09/06ISR Number: 4906352-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20060200582 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anorgasmia Risperdal PS Initial or Prolonged Anticonvulsant Drug Level Risperdal SS Decreased Campral SS ORAL Encephalopathy Celexa SS ORAL Celexa SS ORAL Celexa SS ORAL Celexa SS ORAL Wellbutrin Sr SS ORAL Wellbutrin Sr SS ORAL Neurontin C Depakote C Glyburide C Lactulose C Corgard C Synthroid C Caltrate C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Multivitamin C Date:02/09/06ISR Number: 4906353-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051202211 Age:78 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Rhabdomyolysis Risperdal PS ORAL Initial or Prolonged Risperdal SS ORAL 22-Feb-2006 08:20 AM Page: 2844 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Risperdal SS ORAL Risperdal SS ORAL Risperdal SS ORAL Brotizolam C ORAL Flunitrazepam C ORAL Mianserin Hydrochloride C ORAL Mianserin Hydrochloride C ORAL Date:02/10/06ISR Number: 4908120-XReport Type:Expedited (15-DaCompany Report #FR-JNJFOC-20051002281 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Creatine Risperdal PS ORAL 332 DAY Initial or Prolonged Phosphokinase Increased Risperdal SS ORAL 332 DAY Drug Interaction Lepticur C UNKNOWN Rhabdomyolysis Mogadon C UNKNOWN Theralene C UNKNOWN Tercian I ORAL Tercian I ORAL Tercian I ORAL Date:02/10/06ISR Number: 4908121-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060105605 Age:40 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Apallic Syndrome Risperdal Consta PS INTRAMUSCULAR taken for one Hospitalization - Blood Glucose Increased year 1 YR Initial or Prolonged Blood Pressure Increased Ergenyl C Brain Oedema Zyprexa C Cerebrovascular Accident Antidiabetics C General Physical Health Antihypertensive C Deterioration Pulmonary Oedema Treatment Noncompliance Date:02/10/06ISR Number: 4908122-3Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20060200563 Age:42 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Somnolence Risperdal PS Initial or Prolonged Stevens-Johnson Syndrome Provigil SS ORAL Other Toxic Epidermal Lexapro SS Necrolysis Date:02/10/06ISR Number: 4908123-5Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060200607 Age:10 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Abdominal Pain Risperdal PS ORAL Initial or Prolonged Headache Oedema Petechiae 22-Feb-2006 08:20 AM Page: 2845 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/10/06ISR Number: 4908124-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050206378 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Risperdal Consta PS INTRAMUSCULAR Swelling Face Haloperidol C Date:02/10/06ISR Number: 4908125-9Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050300092 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyspnoea Risperdal Consta PS INTRAMUSCULAR Swelling Face Date:02/10/06ISR Number: 4908126-0Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20060200868 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Angle Closure Glaucoma Risperdal PS Delusion Zyprexa C Depression Date:02/10/06ISR Number: 4908127-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060200881 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Withdrawal Syndrome Risperdal PS Initial or Prolonged Neonatal Luvox SS Eye Movement Disorder Artane SS Hypotonia Rivotril SS Irritability Seroquel SS Liver Function Test Hiberna SS Abnormal Silece SS Pyrexia Somnolence Tremor Date:02/10/06ISR Number: 4908129-6Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060201244 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Adverse Drug Reaction Risperidone PS UNKNOWN Initial or Prolonged Date:02/10/06ISR Number: 4908130-2Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051003756 Age:71 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Liver Disorder Risperdal PS ORAL 0.5-1 mg Stevens-Johnson Syndrome 22-Feb-2006 08:20 AM Page: 2846 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/10/06ISR Number: 4908131-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20051105983 Age:74 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Platelet Count Decreased Risperdal PS ORAL Sodium Valproate SS ORAL Chlorpromazine-Prome thazine SS ORAL Biperiden Hydrochloride C ORAL Distigmine Bromide C ORAL Senna Extract C ORAL Date:02/10/06ISR Number: 4908132-6Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20051204285 Age:79 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Asthenia Risperdal PS ORAL 4 DAY Initial or Prolonged Confusional State Sintrom C ORAL Gait Disturbance Hallucination Vertigo Date:02/10/06ISR Number: 4908185-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20060200470 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anger Concerta PS Anorexia Risperdal SS Petit Mal Epilepsy Date:02/10/06ISR Number: 4908394-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051105079 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Loss Of Consciousness Risperdal Consta PS OTHER given on Platelet Count Decreased 28-Nov (year unspecified) Haldol C Cogentin C Benadryl C Date:02/10/06ISR Number: 4908395-7Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060105901 Age:68 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Anaemia Risperdal PS ORAL Sennoside SS Biperiden Hydrochloride SS Magnesium Oxide SS Aspirin-Dialuminate SS Aspirin-Dialuminate SS Aspirin-Dialuminate SS Hypnotics And Sedatives, Antianxietics SS Purgatives And 22-Feb-2006 08:20 AM Page: 2847 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clysters C Date:02/10/06ISR Number: 4908834-1Report Type:Expedited (15-DaCompany Report #CA-JNJFOC-20060200831 Age:46 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Interaction Risperdal PS Initial or Prolonged Haemoptysis Paroxetine SS Temazepam C Doxepin C Iron C Laxative C Date:02/13/06ISR Number: 4909025-0Report Type:Expedited (15-DaCompany Report #JP-SOLVAY-00305004308 Age:0 DY Gender:Female I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Withdrawal Syndrome Luvox 25 PS TRANSPLACENTAL Daily dose: Neonatal 50 Eye Movement Disorder milligram(s) 5 MON Fever Neonatal Artane SS TRANSPLACENTAL Daily dose: 4 Hypotonia Neonatal milligram(s) 5 MON Irritability Rivotril SS TRANSPLACENTAL Daily dose: 1 Somnolence Neonatal milligram(s) 5 MON Tremor Neonatal Seroquel SS TRANSPLACENTAL Daily dose: 75 milligram(s) 5 MON Hiberna SS TRANSPLACENTAL Daily dose: 75 milligram(s) 5 MON Silece SS TRANSPLACENTAL Daily dose: 4 milligram(s) 5 MON Risperdal SS TRANSPLACENTAL Daily dose: 4 milligram(s) 24 MON Date:02/14/06ISR Number: 4910755-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20060201308 Age:17 YR Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Sudden Death Concerta PS Risperdal SS Lithium SS Date:02/14/06ISR Number: 4910774-9Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060201040 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Level Decreased Risperdal Consta PS INTRAMUSCULAR Initial or Prolonged Psychotic Disorder Date:02/14/06ISR Number: 4910775-0Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060201105 Age:59 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Bronchopneumonia Risperdal Consta PS INTRAMUSCULAR Cymbalta SS ORAL Maxitrol C OPHTHALMIC 22-Feb-2006 08:20 AM Page: 2848 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Maxitrol C OPHTHALMIC Maxitrol C OPHTHALMIC Diclofenac C ORAL Lorazepam C ORAL Benzydamine C TOPICAL Date:02/14/06ISR Number: 4910776-2Report Type:Expedited (15-DaCompany Report #IE-JNJFOC-20060201108 Age:4 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other White Blood Cell Count Risperdal Consta PS INTRAMUSCULAR Decreased Date:02/14/06ISR Number: 4910777-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20060102830 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Blood Prolactin Increased Risperdal PS Brain Neoplasm Galactorrhoea Date:02/14/06ISR Number: 4910778-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20040907979 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Anxiety Risperdal PS ORAL Initial or Prolonged Blood Creatine Risperdal SS ORAL Phosphokinase Increased Risperdal SS ORAL Blood Creatinine Risperdal SS ORAL Increased Risperdal SS ORAL Blood Urea Increased Risperdal SS ORAL Dehydration Sodium Valproate C ORAL Nausea Brotizolam C ORAL Poriomania Biperiden Pyelonephritis Hydrochloride C ORAL Schizophrenia Levomepromazine Maleate C ORAL Lorazepam C ORAL Lorazepam C ORAL Lorazepam C ORAL Metoclopramide C ORAL Levofloxacin C ORAL Haloperidol C Date:02/14/06ISR Number: 4910779-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060105894 Age:53 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Haemoglobin Decreased Risperdal PS ORAL Platelet Count Decreased Biperiden Hydrochloride C Chlorpromazine-Prome thazine Combined Drug C Flunitrazepam C 22-Feb-2006 08:20 AM Page: 2849 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/14/06ISR Number: 4910780-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060103817 Age:74 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Bradycardia Risperdal PS ORAL Initial or Prolonged Depressed Level Of Ivermectin C Other Consciousness Hypothermia Date:02/14/06ISR Number: 4911138-4Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060104305 Age:59 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Drug Abuser Topalgic Lp PS ORAL Initial or Prolonged Drug Dependence Risperdal SS ORAL General Nutrition Imovane SS ORAL Disorder Skenan SS ORAL Atarax SS ORAL Depamide SS ORAL Noctran SS ORAL Noctran SS ORAL Noctran SS ORAL Norset (Mirtazapine) SS Neurontin SS ORAL Aldactone C UNKNOWN Diffu K C UNKNOWN Burinex C UNKNOWN Tahor C UNKNOWN Eupressyl C UNKNOWN Doliprane C UNKNOWN Allopurinol C UNKNOWN Date:02/14/06ISR Number: 4911141-4Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060201518 Age: Gender: I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Electroencephalogram Risperdal PS ORAL Initial or Prolonged Abnormal Renal Failure Date:02/14/06ISR Number: 4911142-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20050500070 Age: Gender:Male I/FU:I Outcome PT Hospitalization - Abdominal Pain Upper Initial or Prolonged Anxiety Disability Appendicitis Other Asthenia Back Pain Blood Alkaline Phosphatase Increased Blood Amylase Increased Blood Urine Present Bronchitis Diabetes Mellitus Insulin-Dependent Diabetic Ketoacidosis Drug Effect Decreased Emotional Distress 22-Feb-2006 08:20 AM Page: 2850 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Headache Hepatomegaly Loss Of Consciousness Report Source Product Role Manufacturer Route Dose Duration Major Depression Risperdal PS ORAL Malaise Risperdal SS ORAL Neck Injury Risperdal SS ORAL Pain Risperdal SS ORAL (1 mg daily Pharyngitis Streptococcal in morning; Pneumonia 1.5 mg daily Sinusitis at bedtime) Depakote C ORAL Depakote C ORAL (250 mg twice daily; 125 mg daily at bedtime) Date:02/15/06ISR Number: 4911875-1Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20051201975 Age:42 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Acne Risperdal PS ORAL Apathy Topamax SS ORAL Convulsion Topamax SS ORAL Hypertrophy Breast Topamax SS ORAL Repetitive Speech Tavor C UNKNOWN Weight Increased Date:02/15/06ISR Number: 4911876-3Report Type:Expedited (15-DaCompany Report #TR-JNJFOC-20051201338 Age:35 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Bradycardia Risperdal Consta PS INTRAMUSCULAR 16 DAY Cardiac Arrest Risperdal SS UNKNOWN 30 DAY Coma Hypotension Hypoxic Encephalopathy Date:02/15/06ISR Number: 4911877-5Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20051003631 Age:30 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Ineffective Risperdal Consta PS INTRAMUSCULAR Dyspnoea Fibromyalgia Gingival Swelling Injection Site Pain Systemic Lupus Erythematosus Toothache Date:02/16/06ISR Number: 4913540-3Report Type:Expedited (15-DaCompany Report #2006UW02168 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Disability Ill-Defined Disorder Seroquel PS Zeneca Polytraumatism Pharmaceutical ORAL Risperdal SS 22-Feb-2006 08:20 AM Page: 2851 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zyprexa SS Date:02/16/06ISR Number: 4913662-7Report Type:Expedited (15-DaCompany Report #FR-JNJFOC-20060201273 Age:4 DEC Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal Consta PS INTRAMUSCULAR taken for a short time Abilify C UNKNOWN Date:02/16/06ISR Number: 4913663-9Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060201521 Age:40 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Respiration Abnormal Risperdal PS ORAL Initial or Prolonged Lorazepam C ORAL Diazepam C ORAL Paroxetine Hydrochloride Hydrate C ORAL Zopiclone C ORAL Date:02/16/06ISR Number: 4913664-0Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060201587 Age:35 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Drug Abuser Risperdal PS ORAL Date:02/16/06ISR Number: 4913665-2Report Type:Periodic Company Report #DE-JNJFOC-20060100667 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Electrocardiogram Qt Risperdal PS UNKNOWN Prolonged Risperdal SS UNKNOWN Remergil C Zopiclone C Verapamil C Digimerck C Dynorm C Alna C Sinupret Forte C Sinupret Forte C Sinupret Forte C Sinupret Forte C Sinupret Forte C Sinupret Forte C dose = dragee Movigol C dose = pouch Date:02/16/06ISR Number: 4913666-4Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20060100254 Age:86 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Death Risperdal PS ORAL Feeling Hot 22-Feb-2006 08:20 AM Page: 2852 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/16/06ISR Number: 4913667-6Report Type:Expedited (15-DaCompany Report #IT-JNJFOC-20060201851 Age:5 DEC Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Cardiac Disorder Risperdal PS ORAL Initial or Prolonged Renal Disorder Weight Increased Date:02/16/06ISR Number: 4913668-8Report Type:Expedited (15-DaCompany Report #DE-JNJFOC-20060201904 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Bradycardia Risperdal PS UNKNOWN Hypothermia Date:02/16/06ISR Number: 4913669-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060202129 Age:6 DEC Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Aggression Risperdal PS ORAL Death Sultopride Restlessness Hydrochloride SS ORAL Sultopride Hydrochloride SS ORAL Date:02/16/06ISR Number: 4913813-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060201601 Age: Gender:Male I/FU:F Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Dyskinesia Risperdal PS ORAL 3 DAY Extrapyramidal Disorder Hallucination Parkinsonian Rest Tremor Date:02/16/06ISR Number: 4913814-6Report Type:Expedited (15-DaCompany Report #NL-JNJFOC-20060202210 Age:21 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Blood Glucose Fluctuation Risperdal PS ORAL Initial or Prolonged Date:02/16/06ISR Number: 4913815-8Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060202780 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Eye Swelling Risperdal Consta PS INTRAMUSCULAR Gamonil C UNKNOWN Date:02/17/06ISR Number: 4914877-4Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20060202693 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Renal Failure Acute Risperdal PS UNKNOWN 22-Feb-2006 08:20 AM Page: 2853 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/17/06ISR Number: 4914878-6Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20060102990 Age:49 YR Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Hospitalization - Idiopathic Risperdal PS ORAL Initial or Prolonged Thrombocytopenic Purpura Date:02/17/06ISR Number: 4914879-8Report Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050502615 Age:43 YR Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Life-Threatening Convulsion Risperdal PS ORAL Hospitalization - Disseminated Impromen SS ORAL Initial or Prolonged Intravascular Coagulation Haldol SS ORAL Other Polydipsia Chloropromazine SS ORAL Systemic Inflammatory Levopromazine SS ORAL Response Syndrome Biperiden Water Intoxication Hydrochloride C ORAL Promethazine Hydrochloride C ORAL Etizolam C ORAL Cloxazolam C ORAL Haloxazolam C ORAL Flunitrazepam C ORAL Date:02/17/06ISR Number: 4915751-XReport Type:Expedited (15-DaCompany Report #US-JNJFOC-20060104836 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Other Neutropenia Risperdal Consta PS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Risperdal Consta SS INTRAMUSCULAR Depakote Er C ORAL Depakote Er C ORAL Date:02/17/06ISR Number: 4915752-1Report Type:Expedited (15-DaCompany Report #CH-JNJFOC-20060202975 Age: Gender:Female I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Dehydration Risperdal PS ORAL Life-Threatening Dysgeusia Dysphagia Moaning Parkinsonism Tardive Dyskinesia Date:02/21/06ISR Number: 4917619-1Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20060203149 Age: Gender:Male I/FU:I Outcome PT Report Source Product Role Manufacturer Route Dose Duration Death Drowning Risperdal Consta PS INTRAMUSCULAR 22-Feb-2006 08:20 AM Page: 2854 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Summary report for FOI selections: Selection by inexact search of active ingredient: RISPERIDONE% Selection by inexact search of Tradename/Verbatim: RISPERDAL% Total number of reports: 12,312 From: 01-NOV-1997 To: Present 22-Feb-2006 08:20 AM Page: 2855