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Clozapine (Clozapine) - Side Effect Reports to FDA

 
 



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 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 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 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 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 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

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 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 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 2012-08-21

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



Possible Clozapine side effects in male

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

Patient: male, weighing 87.0 kg (191.4 pounds)

Reactions: Intestinal Ischaemia, Dissociative Disorder, Colitis Ischaemic, Anaemia, Intestinal Obstruction, Delirium, Hypokalaemia, Lung Disorder, Hypomagnesaemia, Hypoalbuminaemia, Suicide Attempt, Septic Shock

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

Drug(s) suspected as cause:
Seroquel
    Dosage: dose progressively increased
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-02-06
    End date: 2012-03-05

Arixtra
    Start date: 2012-01-01
    End date: 2012-03-01

Atarax

Clozapine
    Dosage: 300 mg to 400 mg per day
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-01-12
    End date: 2012-01-19

Codeine Sulfate
    Administration route: Oral
    Start date: 2012-02-01
    End date: 2012-03-01

Sandostatin
    Start date: 2012-02-01
    End date: 2012-03-01

Nexium
    Administration route: Oral

Tranxene
    Administration route: Oral
    Indication: Agitation
    Start date: 2012-01-27
    End date: 2012-03-05

Imodium
    Administration route: Oral
    Indication: Diarrhoea
    Start date: 2012-02-01
    End date: 2012-03-01

Tranxene
    Administration route: Oral
    Indication: Anxiety
    Start date: 2012-01-27
    End date: 2012-03-05



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

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