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These highlights do not include all the information needed to use CLOZARIL safely and effectively. See full prescribing information for CLOZARIL. CLOZARIL® (clozapine) tablets, for oral use Initial U.S. Approval: 1989
Medication labelWhy this: Advisory · dailymed-prescription
CLOZARIL is indicated for the treatment of severely ill patients with schizophrenia who fail to respond adequately to standard antipsychotic treatment. Because of the significant risk of agranulocytosis and seizure associated with its use, CLOZARIL should be used only in patients who have failed to respond adequately to standard antipsychotic treatment . [see Warnings and Precautions (5.1, 5.4)] The effectiveness of CLOZARIL in treatment-resistant schizophrenia was demonstrated in a 6-week, randomized, double-blind, active-controlled study comparing CLOZARIL and chlorpromazine in patients who had failed other antipsychotics . [see Clinical Studies (14.1)] CLOZARIL is indicated for reducing the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder who are judged to be at chronic risk for re-experiencing suicidal behavior, based on history and recent clinical state. Suicidal behavior refers to actions by a patient that put him/herself at risk for death. The effectiveness of CLOZARIL in reducing the risk of recurrent suicidal behavior was demonstrated over a 2-year treatment period in the InterSePT trial . TM [see Clinical Studies (14.2)]
- generic_name
- clozapine
- product_names
- clozapine
- ndc
- 64725-1260, 0078-0126, 64725-1260-1
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en