Article March 1, 1997

Safety of Olanzapine

Charles M. Beasley, Jr., M.D.; Gary D. Tollefson, M.D., Ph.D.; Pierre V. Tran, M.D.

J Clin Psychiatry 1997;58(suppl 10):13-17

Article Abstract

Clinical safety data for treatment of acute schizophrenia with olanzapine, a new atypical antipsychoticagent, are summarized. The primary clinical trial safety database included 2500 patients treatedwith olanzapine, 810 with haloperidol, and 236 with placebo. The overall discontinuation rate fromolanzapine treatment was low. Significant adverse events included somnolence, weight gain, andasymptomatic treatment-emergent transaminase elevation. Minimal parkinsonism and akathisia withrare dystonia were noted. No hematotoxicity was noted. The incidence of seizures and sexual dysfunction was rare.