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:Di