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Risperdal Consta (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 Consta (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 (601)
Death (89)
Life Threatening Events (39)
Disability (26)

Reports by Reaction Type

Hospitalisation (49)Drug Ineffective (35)Weight Increased (35)Inappropriate Schedule of Drug Administration (32)Psychotic Disorder (32)Product Quality Issue (30)Condition Aggravated (28)Gait Disturbance (28)Depression (27)Abnormal Behaviour (27)Exposure To Contaminated Device (26)Injury Associated With Device (25)

Below are a few examples of reports where side effects / adverse reactions may be related to Risperdal Consta (Risperidone). For a complete list or a specific selection of reports, please use the links above.

Possible Risperdal Consta side effects in 35 year old male

Reported by a pharmacist from Australia on 2012-08-27

Patient: 35 year old male

Reactions: Hospitalisation, Treatment Noncompliance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Risperdal Consta
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-08-01

Risperdal Consta



Possible Risperdal Consta side effects in 31 year old male

Reported by a physician from Ireland on 2012-08-27

Patient: 31 year old male

Reactions: Condition Aggravated, Substance Abuse

Drug(s) suspected as cause:
Risperdal Consta



Possible Risperdal Consta side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: male

Reactions: Sudden Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Loxapine HCL
    Dosage: 100/50/50/100
    Administration route: Oral
    Start date: 2012-07-16

Loxapine HCL
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2012-07-15

Loxapine HCL
    Administration route: Oral
    Start date: 2012-07-23
    End date: 2012-07-23

Loxapine HCL
    Administration route: Oral

Risperdal Consta
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01
    End date: 2012-07-02

Zyprexa
    Dosage: 10/20
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2012-07-17

Zyprexa
    Administration route: Oral
    Start date: 2012-07-16

Zyprexa
    Administration route: Oral
    End date: 2012-07-23

Other drugs received by patient: Risperdal; Valium; Trimeprazine Tartrate; Valium; Valium; Valium; Valium; Akineton; Tranxene; Valium; Imovane



Possible Risperdal Consta side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male, weighing 86.2 kg (189.6 pounds)

Reactions: Incorrect Route of Drug Administration, Confusional State, Rhinitis, Somnolence, Malaise, Palpitations, Sedation, Heart Rate Increased, Extrapyramidal Disorder, Neuroleptic Malignant Syndrome

Drug(s) suspected as cause:
Risperdal Consta



Possible Risperdal Consta side effects in 41 year old male

Reported by a physician from France on 2012-08-24

Patient: 41 year old male

Reactions: Agranulocytosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clonazepam
    Administration route: Oral
    Indication: Schizophrenia, Paranoid Type
    Start date: 2011-11-11
    End date: 2012-04-21

Clonazepam
    Administration route: Oral
    Start date: 2012-04-25

Clozapine
    Administration route: Oral
    Indication: Schizophrenia, Paranoid Type
    Start date: 2011-11-11
    End date: 2012-04-21

Havlane
    Administration route: Oral
    Start date: 2012-04-25

Havlane
    Administration route: Oral
    Indication: Schizophrenia, Paranoid Type
    Start date: 2011-11-11
    End date: 2012-04-21

Risperdal Consta
    Start date: 2012-04-25

Risperdal Consta
    Indication: Schizophrenia, Paranoid Type
    Start date: 2011-11-11
    End date: 2012-04-21



Possible Risperdal Consta side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: male

Reactions: Product Quality Issue, Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Risperdal Consta
    Start date: 2012-07-01

Risperdal Consta
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Cogentin; Risperdal; Desyrel



Possible Risperdal Consta side effects in male

Reported by a physician from Ireland on 2012-08-21

Patient: male

Reactions: Condition Aggravated, Substance Abuse

Drug(s) suspected as cause:
Risperdal Consta



Possible Risperdal Consta side effects in female

Reported by a consumer/non-health professional from Australia on 2012-08-21

Patient: female

Reactions: Dyspnoea, Swelling Face, Hypersensitivity, Headache, Drug Prescribing Error, Malaise, Chest Pain, Vision Blurred, Coordination Abnormal, Injury

Drug(s) suspected as cause:
Risperdal Consta



Possible Risperdal Consta side effects in male

Reported by a consumer/non-health professional from France on 2012-08-20

Patient: male

Reactions: Incorrect Drug Administration Duration, Dependence, Drug Prescribing Error

Drug(s) suspected as cause:
Risperdal Consta

Other drugs received by patient: Vitamin D; Folic Acid; Unknown Medication; Unknown Medication



Possible Risperdal Consta side effects in male

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-20

Patient: male

Reactions: Exposure To Contaminated Device, Device Malfunction

Drug(s) suspected as cause:
Risperdal Consta



Possible Risperdal Consta side effects in male

Reported by a consumer/non-health professional from Sweden on 2012-08-20

Patient: male

Reactions: Tobacco User, Economic Problem, Mania, Restlessness, Insomnia

Drug(s) suspected as cause:
Lamictal
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Paliperidone
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Risperdal Consta
    Indication: Product Used FOR Unknown Indication



Possible Risperdal Consta side effects in

Reported by a pharmacist from Japan on 2012-08-20

Patient:

Reactions: Inappropriate Schedule of Drug Administration, Renal Impairment, Diabetes Mellitus

Drug(s) suspected as cause:
Risperdal
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Risperdal Consta
    Indication: Product Used FOR Unknown Indication



Possible Risperdal Consta side effects in 32 year old male

Reported by a consumer/non-health professional from United Kingdom on 2012-08-20

Patient: 32 year old male

Reactions: Confusional State, Muscle Twitching, Social Problem, Hypokinesia, Fatigue, TIC, Vision Blurred, Feeling Abnormal

Drug(s) suspected as cause:
Risperdal Consta

Risperdal Consta
    Indication: Product Used FOR Unknown Indication



Possible Risperdal Consta side effects in female

Reported by a physician from South Africa on 2012-08-17

Patient: female

Reactions: Slow Response To Stimuli, Extrapyramidal Disorder

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

Risperdal Consta
    Indication: Product Used FOR Unknown Indication



Possible Risperdal Consta side effects in

Reported by a consumer/non-health professional from Japan on 2012-08-17

Patient:

Reactions: Irritability, Hallucination, Auditory, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Risperdal Consta



Possible Risperdal Consta side effects in male

Reported by a consumer/non-health professional from Spain on 2012-08-13

Patient: male

Reactions: Overdose, Psychotic Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Risperdal Consta
    Indication: Psychotic Disorder
    Start date: 2008-01-01

Topamax
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-01-01

Other drugs received by patient: Unknown Medication



Possible Risperdal Consta side effects in male

Reported by a consumer/non-health professional from Canada on 2012-08-13

Patient: male

Reactions: Haemoglobin Decreased, Face Oedema, Hypoglycaemia, Hyperglycaemia, Blood Albumin Decreased, Convulsion, Ascites

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Risperdal Consta



Possible Risperdal Consta side effects in 47 year old male

Reported by a physician from Norway on 2012-08-13

Patient: 47 year old male

Reactions: Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Risperdal Consta



Possible Risperdal Consta side effects in male

Reported by a physician from United Kingdom on 2012-08-09

Patient: male

Reactions: Thought Blocking, Cognitive Disorder, Treatment Noncompliance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Risperdal
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Risperdal Consta
    Indication: Product Used FOR Unknown Indication



Possible Risperdal Consta side effects in 63 year old male

Reported by a pharmacist from Japan on 2012-08-08

Patient: 63 year old male, weighing 76.0 kg (167.2 pounds)

Reactions: Contusion, Rhabdomyolysis, Pyrexia, Bronchitis, Treatment Noncompliance, Fall, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Doral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-04-25

Risperdal
    Administration route: Oral
    Start date: 2012-04-18
    End date: 2012-04-28

Risperdal
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-04-12

Risperdal Consta
    Indication: Schizophrenia
    Start date: 2012-05-11

Zolpidem
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-04-25

Other drugs received by patient: Akineton; Magmitt; Neophagen C; AN Unknown Medication



Possible Risperdal Consta side effects in male

Reported by a individual with unspecified qualification from United States on 2012-08-07

Patient: male

Reactions: Urinary Incontinence

Drug(s) suspected as cause:
Risperdal Consta



Possible Risperdal Consta side effects in female

Reported by a pharmacist from Australia on 2012-08-06

Patient: female

Reactions: Exposure To Contaminated Device, Needle Issue, Injury Associated With Device

Drug(s) suspected as cause:
Risperdal Consta



Possible Risperdal Consta side effects in male

Reported by a physician from Austria on 2012-08-06

Patient: male

Reactions: Blood Glucose Abnormal

Drug(s) suspected as cause:
Risperdal Consta



Possible Risperdal Consta side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: male

Reactions: Movement Disorder, Weight Decreased, Drug Ineffective, Pain, Muscle Tightness, Neck Pain, Musculoskeletal Disorder, Adverse Event, Injury, Depression, Muscle Spasms, Back Pain, Inappropriate Schedule of Drug Administration, Dysphagia, Dystonia, Grimacing, Condition Aggravated, Abnormal Behaviour, Torticollis, Muscle Twitching, Dissociation, Suicide Attempt, Disturbance in Attention, Tardive Dyskinesia, Extrapyramidal Disorder, Gait Disturbance, Hypertension

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cogentin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-11

Invega
    Administration route: Oral
    Indication: Schizophrenia, Paranoid Type
    Start date: 2008-05-01
    End date: 2009-11-01

Risperdal
    Administration route: Oral
    Indication: Schizophrenia, Paranoid Type
    Start date: 2010-07-07
    End date: 2011-02-02

Risperdal Consta
    Start date: 2009-01-01

Risperdal Consta
    Dosage: ndc 050468-306
    Start date: 2010-04-07
    End date: 2011-02-02

Risperdal Consta
    Dosage: ndc 050468-306
    Indication: Schizophrenia, Paranoid Type
    Start date: 2010-04-07
    End date: 2011-02-02

Risperdal Consta
    Dosage: every 4 to 6 weeks
    Start date: 2010-01-01
    End date: 2010-01-01

Risperdal Consta
    Start date: 2010-04-01
    End date: 2010-08-01

Risperdal Consta
    Indication: Major Depression
    Start date: 2010-04-01
    End date: 2010-08-01

Risperdal Consta
    Dosage: every 4 to 6 weeks
    Start date: 2010-01-01
    End date: 2010-01-01

Risperdal Consta
    Start date: 2010-05-01
    End date: 2010-10-01

Risperdal Consta
    Dosage: every 4 to 6 weeks
    Start date: 2010-01-01
    End date: 2010-01-01

Risperdal Consta
    Dosage: ndc 050468-306
    Start date: 2010-04-07
    End date: 2011-02-02

Risperdal Consta
    Indication: Bipolar Disorder
    Start date: 2009-01-01

Risperdal Consta
    Start date: 2009-01-01

Risperdal Consta
    Start date: 2010-05-01
    End date: 2010-10-01

Risperdal Consta
    Start date: 2010-05-01
    End date: 2010-10-01

Risperdal Consta
    Start date: 2010-04-01
    End date: 2010-08-01

Zyprexa
    Indication: Schizophrenia



Possible Risperdal Consta side effects in female

Reported by a physician from France on 2012-08-06

Patient: female, weighing 65.0 kg (143.0 pounds)

Reactions: Cerebrovascular Accident, Viith Nerve Paralysis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Risperdal Consta

Other drugs received by patient: Tegretol



Possible Risperdal Consta side effects in 76 year old male

Reported by a physician from United Kingdom on 2012-08-06

Patient: 76 year old male

Reactions: Pancreatitis Acute

Adverse event resulted in: death

Drug(s) suspected as cause:
Risperdal Consta



Possible Risperdal Consta side effects in male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-06

Patient: male

Reactions: Renal Impairment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Risperdal Consta

Other drugs received by patient: Insulin



Possible Risperdal Consta side effects in 37 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-06

Patient: 37 year old male

Reactions: Apathy, Tongue Biting, Lethargy

Drug(s) suspected as cause:
Risperdal Consta



Possible Risperdal Consta side effects in

Reported by a physician from United States on 2012-08-03

Patient:

Reactions: Treatment Noncompliance

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

Risperdal Consta
    Indication: Product Used FOR Unknown Indication



Possible Risperdal Consta side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient:

Reactions: Product Quality Issue, Akathisia, Fatigue, Sleep Disorder, Panic Disorder

Drug(s) suspected as cause:
Cogentin
    Indication: Akathisia

Invega Sustenna
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01

Risperdal Consta
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Wellbutrin XL; Ativan

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