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Clozaril (Clozapine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Clozaril (Clozapine) 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 (4575)
Death (875)
Life Threatening Events (234)
Disability (138)

Reports by Reaction Type

White Blood Cell Count Increased (651)White Blood Cell Count Decreased (523)Neutrophil Count Increased (513)Death (423)Neutrophil Count Decreased (407)Platelet Count Decreased (398)Malaise (352)Neutropenia (345)Haemoglobin Decreased (310)Pyrexia (235)Urinary Tract Infection (232)Mental Impairment (230)

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

Possible Clozaril side effects in male

Reported by a pharmacist from United Kingdom on 2012-08-27

Patient: male

Reactions: Rheumatoid Arthritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozaril



Possible Clozaril side effects in male

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

Patient: male

Reactions: Mental Impairment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozaril



Possible Clozaril side effects in male

Reported by a physician from United Kingdom on 2012-08-27

Patient: male, weighing 62.0 kg (136.4 pounds)

Reactions: Overdose, Depression, Schizophrenia, Paranoid Type, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozaril
    Dosage: 375 mg, qd
    Start date: 2012-07-03

Clozaril
    Dosage: 4 to 6 tablets
    Start date: 2012-06-29

Clozaril
    Dosage: 375 mg, daily
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2011-08-20

Other drugs received by patient: Paroxetine HCL; Simvastatin; Atenolol; Doxazosin Mesylate; Amisulpride; Aripiprazole



Possible Clozaril side effects in male

Reported by a physician from United Kingdom on 2012-08-27

Patient: male

Reactions: Dysstasia, Hypotension, Dizziness, Salivary Hypersecretion

Drug(s) suspected as cause:
Clozaril



Possible Clozaril side effects in female

Reported by a physician from United Kingdom on 2012-08-27

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Clozaril



Possible Clozaril side effects in male

Reported by a physician from United Kingdom on 2012-08-27

Patient: male

Reactions: Mental Impairment, Colon Cancer, Neuroleptic Malignant Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozaril
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2010-11-01
    End date: 2011-09-29

Clozaril
    Dosage: unk ukn, unk

Other drugs received by patient: Paliperidone; Olanzapine



Possible Clozaril side effects in male

Reported by a physician from United Kingdom on 2012-08-27

Patient: male

Reactions: Sudden Cardiac Death, Circulatory Collapse

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clozaril



Possible Clozaril side effects in male

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

Patient: male

Reactions: Neutrophil Count Increased, Lymphoma, White Blood Cell Count Increased

Drug(s) suspected as cause:
Clozaril



Possible Clozaril side effects in male

Reported by a physician from United Kingdom on 2012-08-27

Patient: male

Reactions: Skin Cancer, Platelet Count Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozaril

Other drugs received by patient: Lithium Carbonate



Possible Clozaril side effects in female

Reported by a physician from United Kingdom on 2012-08-27

Patient: female, weighing 81.0 kg (178.2 pounds)

Reactions: Pneumonia, Respiratory Failure, Malignant Glioma, Chronic Obstructive Pulmonary Disease

Adverse event resulted in: death

Drug(s) suspected as cause:
Clozaril
    Dosage: 360 mg, (160 mg mane and 200 mg nocte)

Clozaril
    Dosage: unk ukn, unk
    Administration route: Oral
    Indication: Schizophrenia, Paranoid Type
    Start date: 1993-11-30

Other drugs received by patient: Acetaminophen / Hydrocodone Bitartrate; Fluticasone Propionate / Salmeterol; Albuterol Sulate; Lansoprazole; Escitalopram; Procyclidine Hydrochloride 2MG TAB



Possible Clozaril side effects in female

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

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Clozaril



Possible Clozaril side effects in male

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

Patient: male

Reactions: Ventricular Extrasystoles, Atrial Septal Defect, Neutrophil Count Increased, Dilatation Ventricular, Ejection Fraction Decreased, Left Atrial Dilatation, Sinus Tachycardia, Blood Glucose Increased

Drug(s) suspected as cause:
Clozaril

Other drugs received by patient: Benztropine Mesylate; Haloperidol; Citalopram Hydrobromide; Valium; Crestor



Possible Clozaril side effects in female

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

Patient: female

Reactions: Haemoglobin Decreased, White Blood Cell Count Decreased, Dyspnoea, Lung Neoplasm, non-Small Cell Lung Cancer, Lower Respiratory Tract Infection, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozaril

Other drugs received by patient: Diazepam; Aripiprazole; Valproic Acid; Fluoxetine HCL; Spiriva



Possible Clozaril side effects in female

Reported by a physician from United Kingdom on 2012-08-27

Patient: female

Reactions: Anxiety, Tachycardia, Therapy Responder

Drug(s) suspected as cause:
Clozaril
    Dosage: 450 mg, daily
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2011-11-18

Hyoscine Hydrobromide
    Dosage: 600 ug,daily
    Administration route: Oral

Risperidone
    Dosage: 2 mg, daily
    Administration route: Oral
    Indication: Schizophrenia

Venlafaxine
    Dosage: 150 mg, daily
    Administration route: Oral
    Indication: Depressed Mood

Other drugs received by patient: Mirtazapine



Possible Clozaril side effects in female

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

Patient: female

Reactions: Renal Failure

Drug(s) suspected as cause:
Clozaril

Other drugs received by patient: Lithium Carbonate



Possible Clozaril side effects in male

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

Patient: male

Reactions: Lymphocyte Count Increased, Chronic Lymphocytic Leukaemia, Monocyte Count Increased, White Blood Cell Count Increased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Clozaril
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2010-11-10

Clozaril
    Dosage: 300 mg/day
    Administration route: Oral
    Start date: 2011-06-27

Other drugs received by patient: Levetiracetam; Simvastatin; Lamotrigine; Levothyroxine Sodium; Hyoscine HBR HYT; Omeprazole; Valproate Sodium; Aripiprazole



Possible Clozaril side effects in male

Reported by a physician from United Kingdom on 2012-08-27

Patient: male

Reactions: Lung Neoplasm Malignant, Lower Respiratory Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozaril



Possible Clozaril side effects in female

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

Patient: female

Reactions: Anxiety, Tachycardia, Therapy Responder

Drug(s) suspected as cause:
Clozaril
    Dosage: 450 mg, daily
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2011-11-18

Hyoscine Hydrobromide
    Dosage: 600 ug,daily
    Administration route: Oral

Risperidone
    Dosage: 2 mg, daily
    Administration route: Oral
    Indication: Schizophrenia

Venlafaxine
    Dosage: 150 mg, daily
    Administration route: Oral
    Indication: Depressed Mood

Other drugs received by patient: Mirtazapine



Possible Clozaril side effects in male

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

Patient: male, weighing 81.7 kg (179.7 pounds)

Reactions: Confusional State, Blood Creatine Phosphokinase Increased, Anaemia, General Physical Health Deterioration, Pyrexia, Disorientation, Fall, C-Reactive Protein Increased, Sepsis, Gait Disturbance, Neuroleptic Malignant Syndrome, Neutropenia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Clozaril

Other drugs received by patient: Simvastatin; Escitalopram; Tamsulosin Hydrochloride; Dekristol; Omeprazole; Hyoscine Hydrobromide; Ferrous Sulfate TAB



Possible Clozaril side effects in male

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

Patient: male

Reactions: Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozaril



Possible Clozaril side effects in male

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

Patient: male

Reactions: Peritonitis

Drug(s) suspected as cause:
Clozaril



Possible Clozaril side effects in female

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

Patient: female

Reactions: Breast Cancer Recurrent

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozaril



Possible Clozaril side effects in male

Reported by a physician from United Kingdom on 2012-08-27

Patient: male

Reactions: Neutrophilia, Fall, Constipation, Abdominal Discomfort, Dehydration, Differential White Blood Cell Count Abnormal, Circulatory Collapse, Fluid Intake Reduced, White Blood Cell Count Increased

Drug(s) suspected as cause:
Clozaril
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2001-07-01

Clozaril
    Dosage: 500 mg, daily
    Administration route: Oral
    Start date: 2004-01-01

Other drugs received by patient: Duloxetine Hydrochloride



Possible Clozaril side effects in female

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

Patient: female

Reactions: Multi-Organ Failure

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clozaril
    Dosage: unk ukn, unk

Clozaril
    Dosage: (1 tablet (25 mg) every night at bedtime along with 4 tablets of 100 mg)
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 1995-10-16

Other drugs received by patient: Entrophen; Quetiapine; Bupropion HCL; Isopto Atropin; Soflax; Valproate Sodium; Novo-Peridol; Metformin HCL; Novo-Peridol; APO-Benztropine; Crestor



Possible Clozaril side effects in male

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

Patient: male

Reactions: Differential White Blood Cell Count Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozaril
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2007-06-27

Clozaril
    Dosage: 350 mg,(150 mg mane and 200 mg notche)
    Administration route: Oral

Other drugs received by patient: Procyclidine Hydrochloride 2MG TAB; Lithium Carbonate; Valproate Sodium



Possible Clozaril side effects in male

Reported by a physician from United Kingdom on 2012-08-27

Patient: male

Reactions: White Blood Cell Count Decreased, Neutrophil Count Increased, Platelet Count Decreased, Antipsychotic Drug Level Above Therapeutic, Lymphoma, Neutrophil Count Decreased, White Blood Cell Count Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clozaril



Possible Clozaril side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Leukaemia, Psychotic Disorder, RED Blood Cell Count Decreased, Concomitant Disease Aggravated, White Blood Cell Count Increased

Drug(s) suspected as cause:
Clozaril



Possible Clozaril side effects in female

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

Patient: female

Reactions: Drug Ineffective, Salivary Hypersecretion, Enuresis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Clozaril

Other drugs received by patient: Seroquel; Effexor XR



Possible Clozaril side effects in male

Reported by a pharmacist from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Clozaril



Possible Clozaril side effects in male

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

Patient: male

Reactions: Death, Fatigue

Adverse event resulted in: death

Drug(s) suspected as cause:
Clozaril
    Dosage: 200 mg, qhs
    Administration route: Oral
    End date: 2010-11-10

Clozaril
    Dosage: 125 mg, qhs
    Administration route: Oral
    Indication: Schizophrenia, Disorganised Type
    Start date: 2010-11-09

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