A 24-year pharmacovigilance study on sex differences in adverse drug reactions to antidepressant drugs.

Depression is more prevalent in women. Antidepressant drugs (ADDs) are often associated with an increased risk for adverse drug reactions (ADRs). Women generally appear to be at greater risk for ADRs. This observational study analyzed the incidence of ADD-related ADRs in relation to sex in 151,426 female and 92,162 male psychiatric inpatients using data from the German pharmacovigilance program "Arzneimittelsicherheit in der Psychiatrie" (AMSP) from 1993 to 2016. The type of ADR and the incidence of ADRs for different ADDs are examined. Among women and men, 0.85% and 0.67% suffered from ADD-induced ADRs (relative risk 1.25, 95% confidence interval 1.15-1.35), respectively. Women had a higher incidence of edema (f 0.055% vs m 0.009%; RR 6.31, CI 3.06-13.04), allergic cutaneous reactions (f 0.057% vs m 0.034%; RR 1.71, CI 1.13-2.57), and hyponatremia (f 0.067% vs m 0.024%; RR 2.82, CI 1.78-4.47). The incidence of sexual dysfunction was significantly higher in men (m 0.044% vs f 0.001%; RR 17.95, CI 4.39-73.48). Almost all ADD classes had a higher incidence of ADRs in women, including selective serotonin reuptake inhibitors (f 0.61% vs m 0.46%; RR 1.25, CI 1.04-1.50), noradrenergic and specific serotonergic antidepressants (f 0.71% vs m 0.48%; RR 1.46, CI 1.18-1.81), and tricyclic antidepressants (f 1.02% vs m 0.92%; RR 1.24, CI 1.03-1.49). These findings highlight the importance of considering sex-specific tolerability of ADDs. An understanding of these differences is a prerequisite for the individualization and optimization of patient care.