Sex Differences in Reported Adverse Drug Reactions of Selective Serotonin Reuptake Inhibitors (Drug Safety)

Abstract Introduction Several studies have investigated sex as a risk factor for the occurrence of adverse drug reactions (ADRs) and found that women are more likely to experience ADRs than men. Objective The aim of this explorative study was to investigate whether differences exist in reported ADRs of selective serotonin reuptake inhibitors (SSRIs) for men and women in the database of the Netherlands Pharmacovigilance Centre Lareb. Methods A ratio of reports concerning women and men, corrected for the number of users, was calculated for all the ADRs reported on SSRIs. Results We found that 16 ADRs were statistically significantly more reported in women than men, and four ADRS were reported more in men than women. Conclusion ADRs more reported in women than men when using SSRIs were usually dose-related ADRs or commonly occurring ADRs. Differences in the pharmacokinetics of SSRIs between men and women may explain why these reports of dose-related ADRs when using SSRIs concern women more than men.