This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to 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 (2113)
Death (536)
Life Threatening Events (141)
Disability (35)
Reports by Reaction Type
Granulocytopenia (326),
Leukopenia (231),
Death (188),
Neutropenia (133),
Pyrexia (122),
White Blood Cell Count Decreased (116),
Drug Interaction (110),
White Blood Cell Count Increased (105),
Malaise (102),
Psychotic Disorder (101),
Agranulocytosis (100),
Neutrophil Count Decreased (99)
Below are a few examples of reports where side effects / adverse reactions may be related to Clozapine. For a complete list or a specific selection of reports, please use the links above.
Possible Clozapine side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27
Patient: male
Reactions: Colitis Ischaemic, Intestinal Obstruction, Septic Shock
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Clozapine
Administration route: Oral
Indication: Schizophrenia
Start date: 2012-01-11
Haloperidol Lactate
Administration route: Oral
Indication: Schizophrenia
End date: 2012-01-01
Possible Clozapine side effects in 48 year old female
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-27
Patient: 48 year old female
Reactions: Catatonia, Neuroleptic Malignant Syndrome
Drug(s) suspected as cause:
Clozapine
Dosage: 25 mg/day
Haloperidol
Dosage: 2mg
Start date: 2008-12-01
Olanzapine
Dosage: up to 10 mg/day
Start date: 2008-01-01
Chlorpromazine HCL
Dosage: 50mg
Start date: 2008-12-01
Other drugs received by patient: Doxazosin Mesylate
Possible Clozapine side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female
Reactions: Cardiac Arrest, Cardiovascular Disorder
Adverse event resulted in: death
Drug(s) suspected as cause:
Clozapine
Other drugs received by patient: Cogentin; Ambien; Wellbutrin XL; Risperdal; Colace; Ativan
Possible Clozapine side effects in 48 year old female
Reported by a physician from Italy on 2012-08-27
Patient: 48 year old female
Reactions: Catatonia, Neuroleptic Malignant Syndrome
Drug(s) suspected as cause:
Clozapine
Dosage: 100 milligram daily;
Haloperidol
Dosage: 2 milligram daily;
Start date: 2008-12-01
Olanzapine
Dosage: up to 10 mg/day
Start date: 2008-01-01
Clozapine
Dosage: overdose
Start date: 2008-11-01
Chlorpromazine HCL
Dosage: 50 milligram daily;
Start date: 2008-12-01
Clozapine
Dosage: 25 milligram daily;
Indication: Intentional Overdose
Other drugs received by patient: Doxazosin Mesylate
Possible Clozapine side effects in 36 year old female
Reported by a physician from United Kingdom on 2012-08-27
Patient: 36 year old female
Reactions: Body Mass Index Decreased, Diabetes Mellitus, Pyrexia, Mean Cell Volume Decreased, Constipation, Abdominal Tenderness, Malaise, Iron Deficiency Anaemia, White Blood Cell Count Increased, Neutrophil Count Increased, Hiatus Hernia, Cardiac Murmur, Urinary Tract Infection, Physical Assault, Skin Disorder, Monocyte Count Increased, White Blood Cell Disorder, Staphylococcal Infection, Thrombocytosis, Hypertension, Sinus Tachycardia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Folic Acid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Zopiclone
Indication: Product Used FOR Unknown Indication
Clozapine
Administration route: Oral
Indication: Schizophrenia
Start date: 2005-05-01
End date: 2005-05-19
Diazepam
Indication: Product Used FOR Unknown Indication
Perindopril
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Lansoprazole
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Trimethoprim
Indication: Urinary Tract Infection
Clozapine
Administration route: Oral
Start date: 2008-06-05
Lactulose
Indication: Product Used FOR Unknown Indication
Clozapine
Administration route: Oral
Start date: 2008-05-19
Clozapine
Administration route: Oral
Start date: 2006-06-05
End date: 2006-07-13
Ferrous Sulfate TAB
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Furosemide; Ramipril; Atorvastatin; Bendroflumethiazide; Aripiprazole
Possible Clozapine side effects in male
Reported by a physician from Malta on 2012-08-27
Patient: male
Reactions: Haemoglobin Decreased, Iron Deficiency Anaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Clozapine
Administration route: Oral
Start date: 2012-07-01
Clozapine
Dosage: 300 mg, bid
Administration route: Oral
Indication: Schizophrenia
Start date: 2007-01-01
End date: 2012-03-01
Possible Clozapine side effects in 48 year old female
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-27
Patient: 48 year old female
Reactions: Catatonia, Neuroleptic Malignant Syndrome
Drug(s) suspected as cause:
Clozapine
Dosage: 25 mg/day
Olanzapine
Dosage: up to 10 mg/day
Start date: 2008-01-01
Chlorpromazine HCL
Dosage: 50mg
Start date: 2008-12-01
Haloperidol
Dosage: 2mg
Start date: 2008-12-01
Other drugs received by patient: Doxazosin Mesylate
Possible Clozapine side effects in female
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-24
Patient: female
Reactions: Haemorrhagic Anaemia, Gastrooesophageal Reflux Disease
Drug(s) suspected as cause:
Levofloxacin
Taxilan
Clozapine
Haloperidol Lactate
Possible Clozapine 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:
Risperdal Consta
Start date: 2012-04-25
Risperdal Consta
Indication: Schizophrenia, Paranoid Type
Start date: 2011-11-11
End date: 2012-04-21
Havlane
Administration route: Oral
Start date: 2012-04-25
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
Indication: Schizophrenia, Paranoid Type
Start date: 2011-11-11
End date: 2012-04-21
Possible Clozapine side effects in male
Reported by a physician from Germany on 2012-08-24
Patient: male
Reactions: C-Reactive Protein Increased, Lipase Increased
Drug(s) suspected as cause:
Clozapine
Other drugs received by patient: Tiapridex
Possible Clozapine side effects in female
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-24
Patient: female
Reactions: Haemorrhagic Anaemia, Gastrooesophageal Reflux Disease
Drug(s) suspected as cause:
Taxilan
Clozapine
Haloperidol Lactate
Levofloxacin
Possible Clozapine side effects in 53 year old male
Reported by a physician from Finland on 2012-08-24
Patient: 53 year old male
Reactions: Psychotic Disorder, Neutrophil Count Decreased
Drug(s) suspected as cause:
Clozapine
Dosage: unk
Administration route: Oral
Clozapine
Dosage: unk
Administration route: Oral
Clozapine
Dosage: unk
Administration route: Oral
Possible Clozapine side effects in
Reported by a pharmacist from United Kingdom on 2012-08-23
Patient:
Reactions: Congestive Cardiomyopathy, Antipsychotic Drug Level Above Therapeutic, Cardiac Failure Congestive
Adverse event resulted in: death
Drug(s) suspected as cause:
Clozaril
Dosage: unk
Administration route: Oral
Start date: 2001-07-01
Aripiprazole
Dosage: 10 mg, unk
Administration route: Oral
Indication: Schizophrenia
Clozaril
Dosage: unk
Administration route: Oral
Start date: 1994-12-05
Mirtazapine
Dosage: 30 mg, unk
Administration route: Oral
Indication: Depressed Mood
Citalopram Hydrobromide
Dosage: 40 mg, unk
Administration route: Oral
Indication: Depressed Mood
Clozapine
Dosage: 450 mg, unk
Administration route: Oral
Indication: Schizophrenia
Clozaril
Dosage: 450 mg, unk
Administration route: Oral
Possible Clozapine side effects in 63 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23
Patient: 63 year old female
Reactions: Cerebrovascular Accident
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Felodipine
Clozapine
Administration route: Oral
Indication: Schizophrenia
Zocor
Administration route: Oral
Possible Clozapine side effects in 28 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23
Patient: 28 year old male
Reactions: Abdominal Pain, Intestinal Ischaemia, Colitis Ischaemic, Peripheral Coldness, Hyperlactacidaemia, Tachycardia, Hypotension, Intestinal Obstruction, Gastrointestinal Necrosis, Pallor, Constipation, Ascites, Dysuria, Abdominal Distension, Septic Shock
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Clozapine
Dosage: 120 mg, qd
Administration route: Oral
Indication: Schizophrenia
Start date: 2012-01-11
End date: 2012-01-01
Clozapine
End date: 2012-02-01
Haloperidol Lactate
End date: 2012-01-01
Other drugs received by patient: Sandostatin; Perikabiven
Possible Clozapine side effects in 50 year old female
Reported by a physician from Finland on 2012-08-23
Patient: 50 year old female
Reactions: Antipsychotic Drug Level Increased, Body Mass Index Increased, Blood Triglycerides Increased, Oropharyngeal Pain, Genital Haemorrhage, Constipation, Liver Disorder, Malaise, C-Reactive Protein Increased, Proteinuria, Urosepsis, Metabolic Disorder, Blood Creatinine Increased, Anaemia, Urinary Tract Infection, Hepatic Enzyme Increased, Renal Impairment, Neoplasm Malignant, Insomnia, Enterococcus Test Positive
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Clozapine
Dosage: 250 mg, qd
Administration route: Oral
Start date: 2012-07-19
Clozapine
Dosage: 500 mg, per day
Administration route: Oral
Other drugs received by patient: Abilify; Sodium Bicarbonate; Obsidan; Haloperidol; Primolut; Metronidazole HCL; Calcium Carbonate; Gaviscon; Terolut
Possible Clozapine side effects in 63 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23
Patient: 63 year old female
Reactions: Cerebrovascular Accident
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Clozapine
Dosage: unk
Administration route: Oral
Indication: Schizophrenia
Simvastatin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Felodipine
Dosage: unk
Indication: Product Used FOR Unknown Indication
Possible Clozapine 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:
Olanzapine
Indication: Product Used FOR Unknown Indication
Haloperidol
Indication: Product Used FOR Unknown Indication
Clozapine
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
Zotepine
Indication: Product Used FOR Unknown Indication
Levomefolate Calcium
Indication: Product Used FOR Unknown Indication
Possible Clozapine side effects in 63 year old female
Reported by a pharmacist from United Kingdom on 2012-08-22
Patient: 63 year old female
Reactions: Cerebrovascular Accident
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Clozapine
Dosage: unk
Administration route: Oral
Indication: Schizophrenia
Simvastatin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Felodipine
Dosage: unk
Indication: Product Used FOR Unknown Indication
Possible Clozapine side effects in female
Reported by a consumer/non-health professional from Germany on 2012-08-22
Patient: female
Reactions: Neutrophil Count Increased, Antipsychotic Drug Level Increased, Fear of Death, Tachycardia, Condition Aggravated, Cerebrovascular Accident, Viith Nerve Paralysis, Dysarthria, Antipsychotic Drug Level Below Therapeutic, Incontinence, Psychotic Disorder, Salivary Hypersecretion, White Blood Cell Count Increased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Clozapine
Dosage: 100 mg, qid
Administration route: Oral
Start date: 2011-02-01
End date: 2011-08-01
Clozapine
Dosage: 300 mg, (0-0-50-250-mg qd)
Administration route: Oral
Start date: 2011-08-04
Other drugs received by patient: Lorazepam; Valproate Sodium
Possible Clozapine side effects in male
Reported by a physician from Germany on 2012-08-22
Patient: male
Reactions: Infection
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Clozapine
Possible Clozapine side effects in 63 year old female
Reported by a pharmacist from United Kingdom on 2012-08-21
Patient: 63 year old female
Reactions: Cerebrovascular Accident
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Felodipine
Indication: Product Used FOR Unknown Indication
Simvastatin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Clozapine
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-31
Possible Clozapine side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-21
Patient: male
Reactions: Colitis Ischaemic, Intestinal Obstruction, Septic Shock
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Haldol
Administration route: Oral
Indication: Schizophrenia
End date: 2012-01-01
Clozapine
Administration route: Oral
Indication: Schizophrenia
Start date: 2012-01-11
Possible Clozapine side effects in 63 year old female
Reported by a pharmacist from United Kingdom on 2012-08-21
Patient: 63 year old female
Reactions: Cerebrovascular Accident
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Clozapine
Indication: Product Used FOR Unknown Indication
Start date: 2012-07-31
Felodipine
Indication: Product Used FOR Unknown Indication
Simvastatin
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Clozapine side effects in
Reported by a physician from Australia on 2012-08-21
Patient:
Reactions: Neuroleptic Malignant Syndrome
Drug(s) suspected as cause:
Vimpat
Indication: Partial Seizures
Start date: 2012-07-01
Clozapine
Indication: Psychotic Disorder
Start date: 2012-08-01
Other drugs received by patient: Zyprexa
Possible Clozapine side effects in 47 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient: 47 year old male, weighing 126.6 kg (278.4 pounds)
Reactions: Product Substitution Issue, Mental Impairment
Drug(s) suspected as cause:
Clozapine
Possible Clozapine side effects in female
Reported by a physician from United Kingdom on 2012-08-21
Patient: female
Reactions: Body Mass Index Decreased, Diabetes Mellitus, Mean Cell Volume Decreased, Pyrexia, Constipation, Abdominal Tenderness, Malaise, Iron Deficiency Anaemia, White Blood Cell Count Increased, Hiatus Hernia, Cardiac Murmur, Neutrophil Count Increased, Urinary Tract Infection, Skin Disorder, Monocyte Count Increased, Aggression, White Blood Cell Disorder, Staphylococcal Infection, Thrombocytosis, Sinus Tachycardia, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diazepam
Dosage: unk ukn, prn
Ferrous Sulfate TAB
Dosage: 200 mg, bid
Administration route: Oral
Clozaril
Administration route: Oral
Start date: 2008-06-05
Lactulose
Dosage: 10 ml, prn
Clozaril
Dosage: unk ukn, unk
Administration route: Oral
Start date: 2006-06-05
End date: 2006-07-13
Lansoprazole
Dosage: 30 mg, qd
Administration route: Oral
Perindopril Erbumine
Dosage: 2 mg, qd
Administration route: Oral
Folic Acid
Dosage: 5 mg, qd
Administration route: Oral
Clozaril
Dosage: 250 mg, qd
Administration route: Oral
Indication: Schizophrenia
Start date: 2005-05-01
End date: 2005-05-19
Trimethoprim
Dosage: unk ukn, unk
Indication: Urinary Tract Infection
Clozapine
Dosage: unk ukn, qd
Clozaril
Dosage: 250 mg, daily
Administration route: Oral
Start date: 2008-05-19
Zopiclone
Dosage: 3.75 mg, qhs
Clozapine
Dosage: unk ukn, unk
Start date: 2008-05-19
Other drugs received by patient: Furosemide; Atorvastatin; Abilify; Ramipril; Bendrofluazide
Possible Clozapine side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-21
Patient: male
Reactions: Ischaemia, Volvulus
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Clozapine
Dosage: long-term
Administration route: Oral
Indication: Schizophrenia, Disorganised Type
Lepticur
Dosage: long-term
Administration route: Oral
Indication: Dyskinesia
Haloperidol Lactate
Dosage: long-term
Administration route: Oral
Indication: Schizophrenia, Disorganised Type
Other drugs received by patient: Tranxene
Possible Clozapine side effects in 46 year old male
Reported by a pharmacist from United Kingdom on 2012-08-21
Patient: 46 year old male, weighing 66.6 kg (146.5 pounds)
Reactions: Incontinence, Urinary Tract Infection, Abnormal Behaviour, Catatonia, Neuroleptic Malignant Syndrome, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Olanzapine
Indication: Product Used FOR Unknown Indication
Clozapine
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2005-03-16
End date: 2012-06-26
Clozapine
Start date: 1997-12-15
End date: 2005-03-15
Other drugs received by patient: Lactulose; Omeprazole; Valproic Acid; Diazepam; Hyoscine HBR HYT; Moviprep; Acetaminophen
Possible Clozapine side effects in
Reported by a physician from Germany on 2012-08-21
Patient:
Reactions: Hypothermia, Dementia, Drug Interaction, Catatonia, Miosis, Liver Function Test Abnormal, Pupil Fixed, Leukopenia, Oxygen Saturation Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Haloperidol Decanoate
Dosage: 100 mg, every 4 weeks
Indication: Schizophrenia, Catatonic Type
Haloperidol
Dosage: 5 mg, / day
Indication: Schizophrenia, Catatonic Type
Clozapine
Dosage: 100 mg, / day
Indication: Schizophrenia, Catatonic Type
Haloperidol
Dosage: 2 mg, / day
Other drugs received by patient possibly interacting with the suspect drug: Lorazepam
Dosage: 3 to 4.5 mg per day,divided into three single doses
Administration route: Oral
Indication: Schizophrenia, Catatonic Type
Lorazepam
Dosage: 1-1-1 mg
Administration route: Oral
Olanzapine
Dosage: 10 mg, / day
Indication: Schizophrenia, Catatonic Type
Olanzapine
Dosage: 10 mg, single
Administration route: Oral
|