Safety

Adverse Events

The most common treatment-emergent adverse events (incidence of .1% and greater than placebo) associated with ZYPREXA IntraMuscular vs placebo IM in 24-hour trials involving agitated patients with schizophrenia or bipolar mania were somnolence (6% vs 3%), dizziness (4% vs 2%), hypotension (2% vs 0%), asthenia (2% vs 1%), tremor (1% vs 0%), and postural hypotension (1% vs 0%).

The most common treatment-emergent adverse events (incidence of =5% and greater than placebo) associated with oral olanzapine (vs placebo) in 6-week schizophrenia trials in adults were somnolence (26% vs 15%), 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 events (incidence of 5% and greater than placebo) associated with oral olanzapine (vs placebo) in 3- and 4-week bipolar I disorder (manic or mixed episodes) trials in adults were somnolence (35% vs 13%), 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%).

See full Prescribing Information for additional Important Safety Information.

HKGZYP2015-09-29T13_37_06



Last Update: 6 Oct 15

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