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Risperdal (Risperidone) - Side Effect Reports to FDA

 
 



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 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 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 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 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 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 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

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



Possible Risperdal side effects in female

Reported by a physician from Japan on 2012-08-22

Patient: female

Reactions: Pulmonary Embolism, Deep Vein Thrombosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clozapine
    Indication: Product Used FOR Unknown Indication

Haloperidol
    Indication: Product Used FOR Unknown Indication

Impromen
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Levomefolate Calcium
    Indication: Product Used FOR Unknown Indication

Olanzapine
    Indication: Product Used FOR Unknown Indication

Risperdal
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Zotepine
    Indication: Product Used FOR Unknown Indication

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