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Risperdal (Risperidone) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Off Label Use ()

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Risperdal (Risperidone) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.

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:
Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral

Seroquel
    Administration route: Oral
    Indication: Anxiety
    Start date: 2012-03-01
    End date: 2012-01-01

Risperdal

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 male

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

Patient: male

Reactions: Off Label Use, Thrombocytopenia, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Risperdal
    Administration route: Oral
    Indication: Autism

Tercian
    Administration route: Oral
    Indication: Autism

Tercian
    Dosage: between 75 to 200 drops per day
    Administration route: Oral



Possible Risperdal side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-13

Patient: female

Reactions: Off Label Use, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prednisone TAB
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-15

Raloxifene Hydrochloride
    Administration route: Oral
    Indication: Prophylaxis
    End date: 2011-12-06

Risperdal
    Administration route: Oral
    Indication: Prophylaxis

Prednisone TAB
    Administration route: Oral
    Start date: 2011-12-06
    End date: 2012-01-31

Raloxifene
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-06
    End date: 2012-05-31

Prednisone TAB
    Administration route: Oral
    Start date: 2012-01-31
    End date: 2012-02-15

Other drugs received by patient: Duragesic-100; Bactrim DS; Adancor; Pyostacine; Acetaminophen and Tramadol HCL; Acetaminophen; Lexomil; Calcium and Vitamin D3; Pantoprazole Sodium; Fluindione



Possible Risperdal side effects in 20 year old male

Reported by a physician from Austria on 2012-08-07

Patient: 20 year old male

Reactions: Hyperthermia, Disseminated Intravascular Coagulation, Coma, Status Epilepticus, Off Label Use, Multi-Organ Failure, Pharyngeal Haemorrhage, Laryngeal Haemorrhage

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Topamax
    Dosage: 100 mg twice daily (1-0-1) with increasing dosage
    Administration route: Oral
    Start date: 2012-01-01
    End date: 2012-07-01

Topamax
    Dosage: graduated increase with 25 mg
    Administration route: Oral
    Indication: Abnormal Behaviour

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

Sertraline Hydrochloride
    Indication: Product Used FOR Unknown Indication



Possible Risperdal side effects in 44 year old male

Reported by a physician from United States on 2012-07-27

Patient: 44 year old male

Reactions: Off Label Use, Restless Legs Syndrome

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral
    Indication: Major Depression

Mirtazapine

Risperdal



Possible Risperdal side effects in 21 year old male

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: 21 year old male, weighing 69.4 kg (152.7 pounds)

Reactions: Weight Decreased, Drug Dose Omission, Wrong Drug Administered, Rash, Aggression, Hostility, Off Label Use, Depression

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2009-01-01

Risperdal

Zyprexa

Seroquel
    Administration route: Oral
    Indication: Antisocial Behaviour
    Start date: 2009-01-01

Seroquel
    Administration route: Oral
    Start date: 2009-10-01

Seroquel
    Administration route: Oral
    Start date: 2009-10-01

Other drugs received by patient: Abilify



Possible Risperdal side effects in 85 year old female

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: 85 year old female

Reactions: Off Label Use, Drug Dose Omission, Belligerence, Insomnia, Gait Disturbance, Feeling Abnormal

Drug(s) suspected as cause:
Seroquel
    Dosage: 25 milligrams in am, 25 milligramms in pm, 50 milligramms at bedtime, total daily dose 100 milligram
    Administration route: Oral
    Indication: Dementia
    Start date: 2010-01-01
    End date: 2011-07-29

Risperdal

Other drugs received by patient: Toprol-XL; Colace; Alprazolam; Simvastatin; Vitamin D; Calcium; Tylenol PM; Namenda; Sucralfate; Melatonin; Prevacid; Nitrofuratonin



Possible Risperdal side effects in female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-06-26

Patient: female

Reactions: Off Label Use, Encephalitis Autoimmune, Neuroleptic Malignant Syndrome

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Citalopram Hydrobromide
    Dosage: 10 mg
    Administration route: Oral
    Start date: 2009-02-01
    End date: 2010-08-13

Risperdal
    Start date: 2010-08-01
    End date: 2010-08-13

Tercian
    Start date: 2010-08-01
    End date: 2010-08-13

Gardasil
    Indication: Immunisation
    Start date: 2008-12-01
    End date: 2009-04-01

Other drugs received by patient: Lorazepam



Possible Risperdal side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-29

Patient: female

Reactions: Off Label Use, Type 2 Diabetes Mellitus, Feeling Abnormal

Drug(s) suspected as cause:
Risperdal
    Indication: Insomnia

Risperdal
    Indication: Nightmare

Risperdal
    Indication: Depression

Unknown Medication
    Indication: Ill-Defined Disorder



Possible Risperdal side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-21

Patient: male, weighing 49.9 kg (109.8 pounds)

Reactions: Personality Change, Increased Appetite, Headache, Off Label Use, Abnormal Dreams, TIC, Bipolar I Disorder, Emotional Disorder, Eye Movement Disorder, Mood Swings, Cough, Crying, Psychomotor Hyperactivity, Restlessness, Rhinitis, Aggression, Apathy, Ear Pain, Drug Ineffective, Quality of Life Decreased, Somnolence, Constipation, Abdominal Pain Upper, Poor Quality Sleep, Weight Increased, Myalgia, Fatigue, Screaming, Anger, Sinusitis, Vomiting, Nausea, Rash, Anxiety, Arthralgia

Drug(s) suspected as cause:
Risperdal
    Administration route: Oral
    Start date: 2005-01-01
    End date: 2005-01-01

Risperdal
    Dosage: 50 mg 1/2 in the am and 1/2 in pm
    Administration route: Oral

Risperdal
    Dosage: 50 mg 1/2 in the am and 1/2 in pm
    Administration route: Oral
    Indication: Bruxism
    Start date: 2006-01-01
    End date: 2011-01-01

Risperdal
    Dosage: 50 mg 1/2 in the am and 1/2 in pm
    Administration route: Oral
    Indication: Asperger's Disorder
    Start date: 2006-01-01
    End date: 2011-01-01

Risperdal
    Administration route: Oral
    Start date: 2005-01-01
    End date: 2005-01-01

Risperdal
    Dosage: 50 mg 1/2 in the am and 1/2 in pm
    Administration route: Oral

Other drugs received by patient: Effexor; Asthma Inhaler



Possible Risperdal side effects in male

Reported by a consumer/non-health professional from United States on 2012-04-27

Patient: male, weighing 40.8 kg (89.8 pounds)

Reactions: Personality Change, Increased Appetite, Quality of Life Decreased, Headache, Abdominal Pain Upper, Myalgia, Weight Increased, Poor Quality Sleep, Off Label Use, Abnormal Dreams, Fatigue, TIC, Bipolar I Disorder, Screaming, Anger, Emotional Disorder, Eye Movement Disorder, Mood Swings, Sinusitis, Cough, Crying, Vomiting, Psychomotor Hyperactivity, Nausea, Restlessness, Rhinitis, Rash, Anxiety, Apathy, Arthralgia, Ear Pain

Drug(s) suspected as cause:
Risperdal
    Administration route: Oral
    Indication: Asperger's Disorder
    Start date: 2006-01-01

Risperdal
    Administration route: Oral
    Indication: Bruxism
    Start date: 2006-01-01

Other drugs received by patient: Effexor; Asthma Inhaler



Possible Risperdal side effects in 88 year old female

Reported by a consumer/non-health professional from Germany on 2012-04-25

Patient: 88 year old female

Reactions: Death, Apathy, Off Label Use, Hyporesponsive To Stimuli

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Seroquel
    Administration route: Oral
    Indication: Mood Disorder DUE To A General Medical Condition

Mirtazapine

Mirtazapine
    Dosage: generic

Lorazepam

Risperdal

Zolpidem Tartrate



Possible Risperdal side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-09

Patient: male

Reactions: Off Label Use, Weight Increased, Ventricular Extrasystoles, Product Quality Issue, Cardiac Murmur, Abnormal Behaviour, Bronchitis

Drug(s) suspected as cause:
Risperdal
    Administration route: Oral
    Indication: Affective Disorder

Risperdal
    Dosage: 0.25 mg in the morning and 0.5 mg in the night
    Administration route: Oral
    Start date: 2009-01-01

Other drugs received by patient: Adderall XR 10; Clonidine



Possible Risperdal side effects in female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-03-01

Patient: female

Reactions: Off Label Use, Neuroleptic Malignant Syndrome

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Tercian
    Start date: 2010-08-01
    End date: 2010-08-13

Risperdal
    Start date: 2010-08-01
    End date: 2010-08-13

Citalopram Hydrobromide
    Dosage: 10 mg
    Administration route: Oral
    Start date: 2009-02-01
    End date: 2010-08-13

Other drugs received by patient: Lorazepam; Gardasil



Possible Risperdal side effects in 68 year old male

Reported by a consumer/non-health professional from Japan on 2012-02-24

Patient: 68 year old male

Reactions: Cataract, Benign Prostatic Hyperplasia, Libido Decreased, Drug Prescribing Error, Ejaculation Disorder, Off Label Use, Malaise, Depression, Asthenia

Drug(s) suspected as cause:
Invega
    Administration route: Oral
    Indication: Depression
    Start date: 2011-04-01
    End date: 2011-06-01

Risperdal
    Administration route: Oral
    Indication: Schizophrenia



Possible Risperdal side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-13

Patient: male, weighing 47.6 kg (104.8 pounds)

Reactions: Off Label Use, Product Quality Issue, Palpitations, Abnormal Faeces, Aggression, Hunger

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Risperdal
    Administration route: Oral
    Start date: 2011-01-01
    End date: 2011-01-01

Risperdal
    Administration route: Oral
    Indication: Attention Deficit / Hyperactivity Disorder
    Start date: 2011-01-01
    End date: 2011-01-01

Risperdal
    Administration route: Oral
    Start date: 2011-01-01
    End date: 2011-01-01

Other Therapeutic Medication
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Invega; Invega



Possible Risperdal side effects in 28 year old female

Reported by a consumer/non-health professional from United States on 2012-01-12

Patient: 28 year old female

Reactions: Off Label Use, Respiratory Disorder, Overdose, Schizoaffective Disorder, Fall, Eye Disorder

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

Risperidone
    Administration route: Oral
    Indication: Schizoaffective Disorder



Possible Risperdal side effects in male

Reported by a consumer/non-health professional from United States on 2012-01-09

Patient: male

Reactions: Off Label Use, Product Quality Issue, Ventricular Extrasystoles, Weight Increased, Cardiac Murmur, Abnormal Behaviour, Bronchitis

Drug(s) suspected as cause:
Risperdal
    Administration route: Oral
    Indication: Affective Disorder

Risperdal
    Dosage: 0.25 mg in the morning and 0.5 mg in the night
    Administration route: Oral
    Start date: 2009-01-01

Other drugs received by patient: Adderall XR 10; Clonidine



Possible Risperdal side effects in 12 year old female

Reported by a physician from France on 2011-12-23

Patient: 12 year old female

Reactions: Off Label Use, Lung Disorder

Drug(s) suspected as cause:
Risperdal



Possible Risperdal side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-14

Patient: male

Reactions: Off Label Use, Product Quality Issue, Ventricular Extrasystoles, Weight Increased, Cardiac Murmur, Abnormal Behaviour, Bronchitis

Drug(s) suspected as cause:
Risperdal
    Dosage: 0.25 mg in the morning and 0.5 mg in the night
    Administration route: Oral
    Start date: 2009-01-01

Risperdal
    Administration route: Oral
    Indication: Affective Disorder

Other drugs received by patient: Adderall XR 10; Clonidine



Possible Risperdal side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-28

Patient: male

Reactions: Off Label Use, Headache, Gynaecomastia

Drug(s) suspected as cause:
Risperdal
    Administration route: Oral
    Indication: Autism

Risperdal
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2006-02-01
    End date: 2007-03-01

Invega
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-01-01
    End date: 2010-01-01

Risperdal
    Administration route: Oral
    Indication: Asperger's Disorder



Possible Risperdal side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2011-10-31

Patient: 66 year old female

Reactions: Off Label Use, Cerebrovascular Accident, Blindness

Drug(s) suspected as cause:
Risperdal



Possible Risperdal side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-28

Patient: female, weighing 90.7 kg (199.6 pounds)

Reactions: Off Label Use, Parkinson's Disease, Gait Disturbance, Hypertension, Masked Facies, Hypertensive Crisis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Risperdal
    Administration route: Oral
    Indication: Major Depression
    Start date: 1999-01-01
    End date: 2000-01-01

Artane
    Indication: Ill-Defined Disorder

Other drugs received by patient: Remeron



Possible Risperdal side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-10

Patient: female, weighing 90.7 kg (199.6 pounds)

Reactions: Off Label Use, Parkinson's Disease, Gait Disturbance, Hypertension, Masked Facies, Hypertensive Crisis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Risperdal
    Administration route: Oral
    Indication: Major Depression
    Start date: 1999-01-01
    End date: 2000-01-01

Artane
    Indication: Ill-Defined Disorder

Other drugs received by patient: Remeron



Possible Risperdal side effects in female

Reported by a consumer/non-health professional from United States on 2011-10-05

Patient: female, weighing 90.7 kg (199.6 pounds)

Reactions: Off Label Use, Parkinson's Disease, Gait Disturbance, Masked Facies, Hypertension, Hypertensive Crisis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Risperdal
    Administration route: Oral
    Indication: Major Depression
    Start date: 1999-01-01
    End date: 2000-01-01

Artane
    Indication: Ill-Defined Disorder

Other drugs received by patient: Remeron

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