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Label Changes for:

Clozaril (clozapine) Oral Tablets

July 2013

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)


July 2013


Postmarketing Experience
  • Nocturnal enuresis


March 2013


Metabolic Changes
  • Atypical antipsychotic drugs, including CLOZARIL have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes may include hyperglycemia, dyslipidemia, and body weight gain. While atypical antipsychotic drugs may produce some metabolic changes, each drug in the class has its own specific risk profile


Postmarketing Experience
  • Hepatobiliary System: hepatotoxicity, hepatic steatosis, hepatic necrosis, hepatic fibrosis, hepatic cirrhosis, liver injury (hepatic, cholestatic, and mixed), and liver failure
  • Urogenital System - Renal failure 


October 2011 



QT Interval Prolongation
  • section added



Drug Interactions and Pharmacodynamic-Related Interactions
  • ... QT prolongation
Pharmacokinetic-Related Interactions
  • ... QT prolongation



Post-marketing Clinical Experience

Cardiovascular system

  • ... QT prolongation



The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.
November 2008


Summary View


Sections Modified


  • Drug Interactions
    • Pharmacokinetic-Related Interactions
      • Concomitant administration of drugs known to inhibit the activity of cytochrome P450 isozymes may increase the plasma levels of clozapine...
        • citalopram (added to list of drugs)


  • Other Events Observed During the
    Premarketing Evaluation of Clozaril (clozapine)
    • Metabolic and Nutritional Disorders (new subsection)
      • hypercholesterolemia and hypertriglyceridemia


For current prescribing information, contact Novartis Pharmaceuticals at 1-888-669-6682.