Last reviewed 2026-04-20 · How we verify

Zyprexa (olanzapine)

At a glance

Approved indications

• Agitation associated with Bipolar Mania
• Agitation associated with Schizophrenia
• Bipolar affective disorder, current episode depression
• Bipolar affective disorder, current episode manic
• Bipolar disorder in remission
• Depression Treatment Adjunct
• Major depressive disorder
• Mixed bipolar I disorder
• Schizophrenia

Boxed warnings

• WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. ZYPREXA (olanzapine) is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.5 ), and Patient Counseling Information ( 17 )] . When using olanzapine and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine is not approved for the treatment of patients with dementia-related psychosis. ( 5.1 , 8.5 , 17 ) When using olanzapine and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax.

Common side effects

No common side effects on file.

Key clinical trials

• A Prospective/Parallel Study on Induced Weight Gain During Atypical Antipsychotic Treatment and Its Management With Psychoeducational Programme (Phase 4)
• Haloperidol vs Olanzapine for the Management of ICU Delirium: A Randomized Clinical Trial (NA)
• A Study of the Safety and Efficacy of Depakote ER Plus an Atypical Antipsychotic Vs. an Atypical Antipsychotic Alone in the Treatment of Schizophrenia (Phase 2)
• Blood Lactate Levels in Patients Treated With Typical or Atypical Antipsychotics (N/A)
• Six Week Double Blind, Randomized Trial of Escitalopram Add On for Treatment Resistant Bipolar Depression (Phase 1)
• NCT00179231 (NA)
• Occurrence and Influencing Factors of Cognitive Impairment in Elderly Patients With Schizophrenia and the Application Effect of Acceptance and Commitment Therapy Nursing Model (NA)
• An Open-label, Prospective, Randomized and Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in No (Phase 4)

Primary sources

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