What are the signs of Clozapine (Clozaril) toxicity?

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From the Guidelines

Clozapine toxicity is a medical emergency that presents with signs such as seizures, agranulocytosis, sedation, weight gain, hypersalivation, elevated liver enzyme levels, orthostatic hypotension, tachycardia, and fever, requiring immediate attention and potential discontinuation of the medication.

Signs and Symptoms of Clozapine Toxicity

The signs of clozapine toxicity can be severe and life-threatening, including:

  • Seizures, which occur in approximately 3% of patients, with the risk increasing as the dose increases, especially if dosage changes are made rapidly 1
  • Agranulocytosis, which occurs in approximately 1% of patients and is potentially fatal, with the risk being higher in youth 1
  • Sedation, weight gain, hypersalivation, elevated liver enzyme levels, orthostatic hypotension, tachycardia, and fever, which are common side effects of clozapine 1
  • Extrapyramidal side effects, which have been noted in some case reports, particularly in youth 1

Monitoring and Prevention

To prevent and monitor clozapine toxicity, the following guidelines are recommended:

  • Weekly blood cell counts during the first 6 months of treatment, then every 2 weeks thereafter, including testing during the 4 weeks after the medication is stopped 1
  • Monitoring of white blood cell count (WBC) and absolute neutrophil count (ANC), with immediate discontinuation of the medication if the WBC drops below 2,000/mm3 or the ANC drops below 1,000/mm3 1
  • Avoidance of concurrent medications that can lower blood cell counts, such as carbamazepine 1
  • Gradual dose escalation, with starting doses of 6.25 to 25 mg/day, depending on the patient's weight, and subsequent increases of no more than 25 to 50 mg once or twice per week 1

From the FDA Drug Label

The most commonly reported signs and symptoms associated with clozapine overdose are: sedation, delirium, coma, tachycardia, hypotension, respiratory depression or failure; and hypersalivation. There are reports of aspiration pneumonia, cardiac arrhythmias, and seizure. The signs of Clozapine (Clozaril) toxicity are:

  • Sedation
  • Delirium
  • Coma
  • Tachycardia
  • Hypotension
  • Respiratory depression or failure
  • Hypersalivation
  • Aspiration pneumonia
  • Cardiac arrhythmias
  • Seizure 2 2

From the Research

Signs of Clozapine Toxicity

The signs of clozapine toxicity can be severe and varied, including:

  • Hematological complications, such as agranulocytosis 3, 4
  • Cardiovascular complications, such as myocarditis, congestive heart failure, and arrhythmias 5, 4
  • Neurological complications, such as seizures, delirium, and obsessive-compulsive symptoms 3, 5, 6
  • Gastrointestinal complications, such as constipation, nausea, and bowel ischemia 3, 4
  • Other complications, such as weight gain, sialorrhea, elevated liver enzymes, enuresis, and fever 3, 4

Delayed Complications

Delayed complications can occur after severe clozapine intoxication, and may include:

  • Delayed clinical presentations, which can occur up to 5 days after intoxication 6
  • Severe complications, such as cardiac arrhythmias, seizures, and respiratory failure 5, 6, 4

Risk Factors

Risk factors for clozapine toxicity include:

  • High doses of clozapine 5, 6
  • Acute medical illness, which can impair CYP1A2 function and lead to toxic levels of the drug 7
  • Combination with other medications, which can increase the risk of adverse effects 3

Treatment

Treatment for clozapine toxicity may include:

  • Supportive care, such as vital support and monitoring of clinical symptoms and vital functions 5, 6
  • Extracorporeal techniques, such as CytoSorb hemoadsorption, which can help to quickly and efficiently reduce clozapine levels to non-toxic serum levels 5
  • Measurement of clozapine levels, which can help to identify patients at risk of toxicity 7

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Management of the adverse effects of clozapine.

Schizophrenia bulletin, 1998

Research

Potentially fatal outcomes associated with clozapine.

Schizophrenia research, 2018

Research

A clozapine conundrum: clozapine toxicity in an acute medical illness.

Australasian psychiatry : bulletin of Royal Australian and New Zealand College of Psychiatrists, 2014

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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