Common Side Effects
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Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with ZYPREXA® (olanzapine) and similar drugs are at an increased risk of death compared to placebo. 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 varied, most appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. ZYPREXA is not approved for the treatment of elderly patients with dementia-related psychosis. |
The most common treatment-emergent adverse event associated with ZYPREXA (vs placebo) in 6-week acute-phase schizophrenia trials was somnolence (26% vs 15%). Other common events were dizziness (11% vs 4%), weight gain (6% vs 1%), personality disorder (COSTART term for nonaggressive objectionable behavior; 8% vs 4%), constipation (9% vs 3%), akathisia (5% vs 1%), and postural hypotension (5% vs 2%).
The most common treatment-emergent adverse event associated with ZYPREXA (vs placebo) in 3- and 4-week bipolar mania trials was somnolence (35% vs 13%). Other common events were dry mouth (22% vs 7%), dizziness (18% vs 6%), asthenia (15% vs 6%), constipation (11% vs 5%), dyspepsia (11% vs 5%), increased appetite (6% vs 3%), and tremor (6% vs 3%).
For additional information about ZYPREXA's safety profile, see the Important Safety Information, including boxed warning, and the full Prescribing Information.
