Adverse events and treatment discontinuations in fluoxetine clinical trials

Abstract

A re-analysis of the profile of adverse events observed in controlled clinical trials in summarized. The data confirm that the side-effects of fluoxetine therapy are different from those of the tricyclic antidepressants (TCAs), both in type and frequency. Moreover, the superior tolerability of fluoxetine compared with the TCAs is confirmed by the significantly lower rate of premature discontinuation in the fluoxetine-treated patients than in the TCA-treated patients.