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Label Changes for:

Clozaril (clozapine) Tablets

October 2011

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- November 2008 and October 2011


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.