Safety database on fluvoxamine: analysis and report.

A review was conducted of the safety and tolerability of fluvoxamine in 54 worldwide marketing studies that enrolled 24,624 patients, the majority of whom were treated with fluvoxamine in uncontrolled studies in depression. In accordance with the general epidemiologic distribution of depressive disorder, female patients and patients aged between 30 and 50 years predominated. The majority of patients were treated for 6 weeks, the most frequent, or modal, total daily dose being 100 mg. Overall, 57.4% of the patients exposed to fluvoxamine did not have any adverse experiences. The greatest proportion of adverse experiences, as defined using COSTART body systems, affected the digestive system (24.1%), the nervous system (23.7%), and the body as a whole (15.3%). The only adverse experience with an incidence greater than 10% was nausea (15.7%); somnolence (6.9%) and asthenia (6.2%) were the next most frequent adverse experiences. Notably, the rates of agitation and anxiety were only 1.4% and 1.3%, respectively. The incidences of adverse experiences generally increased with age and were slightly higher in females than in males. In total, 15.1% of patients discontinued treatment prematurely as a result of adverse experiences, principally nausea, dizziness, vomiting, somnolence, abdominal pain, and headache. The overall incidence of serious adverse events in association with fluvoxamine treatment was 2.5% when U.S. Food and Drug Administration criteria and the most conservative approach, without causality judgments, were used.(ABSTRACT TRUNCATED AT 250 WORDS)