This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Risperdal (Risperidone) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (1585)
Death (181)
Life Threatening Events (106)
Disability (35)
Reports by Reaction Type
Weight Increased (126),
Self Injurious Behaviour (111),
Somnolence (89),
Suicide Attempt (85),
Drug Ineffective (62),
Aggression (55),
Multiple Drug Overdose Intentional (53),
Pneumonia (53),
Type 2 Diabetes Mellitus (53),
Insomnia (52),
Intentional Overdose (51),
Abnormal Behaviour (51)
Below are a few examples of reports where side effects / adverse reactions may be related to Risperdal (Risperidone). For a complete list or a specific selection of reports, please use the links above.
Possible Risperdal side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Maternal Exposure During Pregnancy, Premature Labour
Drug(s) suspected as cause:
Risperdal
Indication: Depression
Zoloft
Indication: Depression
Possible Risperdal side effects in male
Reported by a physician from Japan on 2012-08-27
Patient: male, weighing 44.0 kg (96.8 pounds)
Reactions: Pneumonia Aspiration, Hallucination, Blood Pressure Decreased, Delusion, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Galantamine Hydrobromide
Administration route: Oral
Start date: 2011-12-10
End date: 2012-01-08
Galantamine Hydrobromide
Administration route: Oral
Indication: Dementia With Lewy Bodies
Start date: 2011-11-24
End date: 2011-12-09
Galantamine Hydrobromide
Administration route: Oral
Start date: 2011-10-23
End date: 2011-11-23
Risperdal
Administration route: Oral
Indication: Dementia With Lewy Bodies
Start date: 2011-11-05
Risperdal
Administration route: Oral
Start date: 2011-10-23
End date: 2011-11-04
Other drugs received by patient: Goodmin; Goodmin; Silece; Gasmotin
Possible Risperdal side effects in 3 year old male
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: 3 year old male
Reactions: Regressive Behaviour, Abnormal Behaviour, Fall, Aggression
Drug(s) suspected as cause:
Risperdal
Possible Risperdal side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Risperdal
Indication: Depression
Zoloft
Indication: Depression
Possible Risperdal side effects in 31 year old male
Reported by a pharmacist from Japan on 2012-08-27
Patient: 31 year old male, weighing 59.0 kg (129.8 pounds)
Reactions: Eosinophilic Pneumonia, Pulmonary Alveolar Haemorrhage, Acute Respiratory Distress Syndrome, Neuroleptic Malignant Syndrome, Pneumonia Staphylococcal
Adverse event resulted in: death
Drug(s) suspected as cause:
Abilify
Administration route: Oral
Indication: Schizophrenia
Start date: 2012-06-23
End date: 2012-06-29
Levotomin
Administration route: Oral
Indication: Schizophrenia
Start date: 2012-06-01
End date: 2012-06-29
Methotrimeprazine Maleate
Risperdal
Dosage: 4mg: 4jun-11jun12(8days) 2mg:12jun-29jun12(18days)
Administration route: Oral
Indication: Schizophrenia
Start date: 2012-06-04
End date: 2012-06-29
Rohypnol
Administration route: Oral
Indication: Schizophrenia
Start date: 2012-06-01
End date: 2012-06-29
Other drugs received by patient: Diazepam; Promethazine HCL; Miya-BM
Possible Risperdal side effects in male
Reported by a physician from Romania on 2012-08-27
Patient: male, weighing 85.0 kg (187.0 pounds)
Reactions: Blood Pressure Increased, Hospitalisation, Pleurisy, Catatonia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Risperdal
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-16
Risperidone
Start date: 2012-05-04
End date: 2012-07-04
Risperidone
Indication: Schizophrenia
Other drugs received by patient: Lorazepam
Possible Risperdal side effects in 75 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27
Patient: 75 year old female
Reactions: Malaise, Fall, Face Injury
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Effexor XR
Dosage: 75 mg, 3x/day
Administration route: Oral
Indication: Abnormal Behaviour
Start date: 2011-10-01
Imovane
Dosage: 7.5 mg, 1x/day
Administration route: Oral
Indication: Abnormal Behaviour
Start date: 2011-10-01
End date: 2012-03-12
Risperdal
Dosage: 2.5 mg, 1x/day
Administration route: Oral
Indication: Abnormal Behaviour
Start date: 2011-10-01
Xanax
Dosage: 0.5 mg, daily
Administration route: Oral
Indication: Abnormal Behaviour
Start date: 2011-10-01
Other drugs received by patient: Micardis; Hydrea; Glucophage; Aspirin; Crestor
Possible Risperdal side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female
Reactions: Asthma, Respiratory Disorder, Cardiac Murmur, Premature Baby, Rash, Constipation, Faecaloma, Pulmonary Artery Stenosis Congenital, Mitral Valve Incompetence, Multiple Allergies, Heart Disease Congenital, Gastrooesophageal Reflux Disease
Drug(s) suspected as cause:
Risperdal
Indication: Foetal Exposure During Pregnancy
Zoloft
Indication: Foetal Exposure During Pregnancy
Possible Risperdal side effects in 31 year old male
Reported by a physician from Japan on 2012-08-27
Patient: 31 year old male, weighing 59.0 kg (129.8 pounds)
Reactions: Eosinophilic Pneumonia, Pulmonary Alveolar Haemorrhage, Acute Respiratory Distress Syndrome, Neuroleptic Malignant Syndrome, Pneumonia Staphylococcal
Adverse event resulted in: death
Drug(s) suspected as cause:
Abilify
Administration route: Oral
Indication: Schizophrenia
Start date: 2012-06-23
End date: 2012-06-29
Levotomin
Administration route: Oral
Indication: Schizophrenia
Start date: 2012-06-01
End date: 2012-06-29
Methotrimeprazine Maleate
Risperdal
Dosage: 4mg: 4jun-11jun12(8days) 2mg:12jun-29jun12(18days)
Administration route: Oral
Indication: Schizophrenia
Start date: 2012-06-04
End date: 2012-06-29
Rohypnol
Administration route: Oral
Indication: Schizophrenia
Start date: 2012-06-01
End date: 2012-06-29
Other drugs received by patient: Diazepam; Promethazine HCL; Miya-BM
Possible Risperdal side effects in
Reported by a physician from Japan on 2012-08-27
Patient:
Reactions: Toxicity To Various Agents
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Risperdal
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Risperidone
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Risperdal side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female, weighing 71.7 kg (157.7 pounds)
Reactions: Anxiety, Pneumonia, Interstitial Lung Disease, Insomnia, Bronchitis, Somnolence
Drug(s) suspected as cause:
Risperdal
Dosage: 1 mg nightly
Administration route: Oral
Indication: Schizophrenia
Start date: 2008-01-01
Risperdal
Administration route: Oral
Start date: 2004-01-01
End date: 2008-01-01
Risperdal
Administration route: Oral
Start date: 2004-01-01
End date: 2008-01-01
Risperdal
Dosage: 1 mg nightly
Administration route: Oral
Indication: Bipolar Disorder
Start date: 2008-01-01
Risperidone
Dosage: 1 mg nightly
Administration route: Oral
Indication: Schizophrenia
Risperidone
Dosage: 1 mg nightly
Administration route: Oral
Indication: Bipolar Disorder
Other drugs received by patient: Tessalon; Crestor; Flonase; Benadryl
Possible Risperdal side effects in male
Reported by a physician from United States on 2012-08-24
Patient: male, weighing 95.7 kg (210.6 pounds)
Reactions: Mental Impairment
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Chantix
Dosage: titration pack
Indication: Smoking Cessation Therapy
Risperdal
Indication: Psychotic Disorder
Possible Risperdal side effects in male
Reported by a consumer/non-health professional from Japan on 2012-08-24
Patient: male
Reactions: Anxiety, Irritability, Stubbornness, Aggression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Risperdal
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Risperidone
Indication: Product Used FOR Unknown Indication
Possible Risperdal side effects in male
Reported by a physician from United States on 2012-08-24
Patient: male, weighing 61.7 kg (135.7 pounds)
Reactions: Pulmonary Embolism
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Risperdal
Dosage: im every 2 weeks
Indication: Schizophrenia
Start date: 2006-01-01
Risperidone
Dosage: 2 mg, by mouth, qhs
Indication: Schizophrenia
Start date: 2006-01-01
End date: 2012-01-01
Other drugs received by patient: Warfarin Sodium
Possible Risperdal side effects in
Reported by a pharmacist from Japan on 2012-08-24
Patient:
Reactions: Respiratory Arrest
Adverse event resulted in: death
Drug(s) suspected as cause:
Risperdal
Possible Risperdal side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: male, weighing 95.3 kg (209.6 pounds)
Reactions: Cholelithiasis, RED Blood Cell Count Increased, Hypertension, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Risperdal
Administration route: Oral
Indication: Schizophrenia
Start date: 1993-01-01
End date: 2007-01-01
Risperidone
Administration route: Oral
Indication: Schizophrenia
Start date: 2007-01-01
Possible Risperdal side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: male
Reactions: Therapeutic Response Decreased, Type 2 Diabetes Mellitus, Activities of Daily Living Impaired, Hypothyroidism, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Risperdal
Possible Risperdal side effects in 44 year old male
Reported by a physician from Italy on 2012-08-23
Patient: 44 year old male, weighing 95.0 kg (209.0 pounds)
Reactions: Hypotension, Tachycardia, Self Injurious Behaviour, Multiple Drug Overdose
Drug(s) suspected as cause:
EN
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-08-14
End date: 2012-08-14
Risperdal
Indication: Product Used FOR Unknown Indication
Risperdal
Start date: 2012-08-14
End date: 2012-08-14
Possible Risperdal side effects in male
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-23
Patient: male
Reactions: Incorrect Dose Administered, Self Injurious Behaviour, Drug Abuse
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Administration route: Oral
Indication: Self Injurious Behaviour
Start date: 2012-07-26
End date: 2012-07-26
Cymbalta
Administration route: Oral
Cymbalta
Administration route: Oral
Cymbalta
Administration route: Oral
Indication: Psychotic Disorder
Start date: 2012-07-26
End date: 2012-07-26
Risperdal
Administration route: Oral
Indication: Psychotic Disorder
Risperdal
Administration route: Oral
Start date: 2012-07-26
End date: 2012-07-26
Risperdal
Administration route: Oral
Start date: 2012-07-26
End date: 2012-07-26
Risperdal
Administration route: Oral
Indication: Self Injurious Behaviour
Possible Risperdal side effects in
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient:
Reactions: Weight Increased, Gynaecomastia, Hepatic Steatosis
Drug(s) suspected as cause:
Risperdal
Possible Risperdal side effects in male
Reported by a physician from Germany on 2012-08-23
Patient: male
Reactions: Dysarthria, Fatigue, Intentional Overdose, Tachycardia, Hypotension, Suicide Attempt
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Risperdal
Possible Risperdal side effects in male
Reported by a consumer/non-health professional from Ireland on 2012-08-23
Patient: male
Reactions: Aphasia, Abasia, Parkinson's Disease, Hyperhidrosis, Foaming AT Mouth, Dysstasia, Incontinence, Hypersomnia
Drug(s) suspected as cause:
Risperdal
Dosage: high dose
Administration route: Oral
Start date: 2010-06-24
Risperdal
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Risperdal
Administration route: Oral
Start date: 2010-10-05
Other drugs received by patient: Chlorpromazine HCL; Diamicron MR; Propranolol; Chlorpromazine HCL; Januvia; Glucophage; Seroquel; Lactulose; Aspirin; Aspirin; Glucosamine; AN Unknown Medication; Metformin; Quetiapine; Moviprep; Sitagliptin; Gliclazide
Possible Risperdal side effects in male
Reported by a physician from United States on 2012-08-23
Patient: male
Reactions: Tachycardia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Invega Sustenna
Indication: Schizophrenia
Start date: 2012-08-01
Risperdal
Administration route: Oral
Indication: Schizophrenia
Possible Risperdal side effects in 21 year old male
Reported by a individual with unspecified qualification from United States on 2012-08-23
Patient: 21 year old male, weighing 63.5 kg (139.7 pounds)
Reactions: Anxiety, Irritability, Off Label Use, Drug Ineffective, Drug Intolerance, Abnormal Behaviour
Drug(s) suspected as cause:
Risperdal
Seroquel
Administration route: Oral
Seroquel
Administration route: Oral
Seroquel
Administration route: Oral
Indication: Anxiety
Start date: 2012-03-01
End date: 2012-01-01
Seroquel
Administration route: Oral
Start date: 2012-04-01
End date: 2012-06-20
Seroquel
Administration route: Oral
Seroquel
Administration route: Oral
Seroquel
Administration route: Oral
Indication: Affective Disorder
Start date: 2012-03-01
End date: 2012-01-01
Seroquel
Administration route: Oral
Start date: 2012-04-01
End date: 2012-06-20
Other drugs received by patient: Miralax
Possible Risperdal side effects in 43 year old female
Reported by a physician from Italy on 2012-08-23
Patient: 43 year old female
Reactions: Multiple Drug Overdose Intentional, Self Injurious Behaviour
Drug(s) suspected as cause:
Clonazepam
Administration route: Oral
Indication: Self Injurious Behaviour
Start date: 2012-08-14
End date: 2012-08-14
Risperdal
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-08-14
End date: 2012-08-14
Possible Risperdal side effects in female
Reported by a pharmacist from Germany on 2012-08-23
Patient: female
Reactions: Hallucination, Gastritis
Drug(s) suspected as cause:
Risperdal
Possible Risperdal side effects in female
Reported by a physician from Japan on 2012-08-23
Patient: female
Reactions: Embolism Arterial
Adverse event resulted in: death
Drug(s) suspected as cause:
Haloperidol Decanoate
Indication: Product Used FOR Unknown Indication
Impromen
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Risperdal
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Risperdal side effects in
Reported by a lawyer from United States on 2012-08-23
Patient:
Reactions: Weight Increased, Osteomyelitis, Gynaecomastia
Drug(s) suspected as cause:
Risperdal
Possible Risperdal side effects in female
Reported by a physician from France on 2012-08-22
Patient: female
Reactions: Dyspnoea, Palpitations, Cytolytic Hepatitis, Depression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetaminophen
Indication: Pain
Start date: 2012-06-05
End date: 2012-06-08
Amlodipine
Administration route: Oral
Start date: 2012-06-02
Arixtra
Indication: Thrombosis Prophylaxis
Start date: 2012-05-01
Bisoprolol Fumarate
Administration route: Oral
Indication: Cardiac Failure
Start date: 2012-06-07
End date: 2012-06-08
Ceftriaxon
Indication: Antibiotic Therapy
Start date: 2012-06-05
End date: 2012-06-09
Crestor
Administration route: Oral
Indication: Dyslipidaemia
Start date: 2012-01-01
End date: 2012-06-08
Digoxin
Administration route: Oral
Indication: Cardiac Failure
Start date: 2012-06-01
Lasix
Administration route: Oral
Indication: Cardiac Failure
Start date: 2012-05-30
End date: 2012-06-05
Metronidazole
Indication: Antibiotic Therapy
Start date: 2012-06-08
End date: 2012-06-09
Potassium Chloride
Administration route: Oral
Indication: Hypokalaemia
Start date: 2012-05-30
Risperdal
Administration route: Oral
Indication: Depression
Start date: 2012-05-01
End date: 2012-06-13
Venlafaxine
Administration route: Oral
Indication: Depression
End date: 2012-06-12
Zymad
Administration route: Oral
Indication: Vitamin D Deficiency
Start date: 2012-06-06
End date: 2012-06-07
Other drugs received by patient: Transpipeg; Aspirin; Ferrous Sulfate TAB
Possible Risperdal side effects in
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient:
Reactions: Cardiac Murmur, Functional Gastrointestinal Disorder, Pulmonary Valve Stenosis, Mitral Valve Incompetence, Left Atrial Dilatation, Right Ventricular Hypertrophy, Constipation, Faecaloma
Drug(s) suspected as cause:
Risperdal
Zoloft
Indication: Depression
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