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Clozaril (clozapine HCl) tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
6 ADVERSE REACTIONS
6.2 Postmarketing Experience
- 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.
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.
- 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