Clozaril (clozapine HCl) tablets

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


September 2014

Summary View


6.2 Postmarketing Experience

Gastrointestinal System

  • added ..... colitis.

Immune System Disorders

  • Angioedema, leukocytoclastic vasculitis.

Skin and Subcutaneous Tissue Disorders

  • added ..... skin pigmentation disorder

Musculoskeletal System and Connective Tissue Disorders

  • Myasthenic syndrome, rhabdomyolysis, and systemic lupus erythematosus.


January 2010

Summary View


Cerebrovascular adverse events
  • An increased risk of cerebrovascular adverse events has been observed in dementia patients treated with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for dementia patients or other patients treated with Clozaril. Clozaril should be used with caution in patients with dementia or risk factors for stroke.
Drug Interactions
  • Pharmacokinetic-Related Interactions: Concomitant administration of drugs known to induce cytochrome P450 enzymes may decrease
    the plasma levels of clozapine...tobacco smoke


Postmarketing Clinical Experience
  • Central Nervous System: obsessive compulsive symptoms
  • Metabolic and Nutritional Disorders: new onset diabetes
  • Respiratory System: pneumonia and lower respiratory tract infection which may be fatal


Page Last Updated: 10/16/2014
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