Adverse drug reactions and gender differences: What changes in drug safety?

Gender differences are influenced by cultural, social, psychological and biological factors. A specific area of medicine has been identified to understand the mechanisms underlying gender differences affecting health status, the course of a disease and pharmacological therapy out-comes. The main gender-related variables affecting drug response are weight, body surface area, height, fat mass, plasma volume and total body water. Gender differences can also influence the drug safety profile; indeed, real-world epidemiological data show a greater incidence and severity of adverse drug reactions in women than in men. Because of several biases in conducting pre-marketing gender-spe-cific studies, post-marketing studies are needed in order to evaluate gender differences in terms of drug efficacy and safety. Therefore, the aim of this review is to provide further evidence in order to show the incidence of specific gender-related adverse drug reactions (ADRs). In this context, we analyzed ADRs reported across the 2001-2018 period in the spontaneous reporting system in the Campania Region (It-aly), in terms of number and severity. In line with literature data, our results showed a higher number of reports involv-ing women than men, especially in those aged 18-64 years. Similarly, severe ADRs were more frequently reported in women. Therefore, an implementation of gender-specific pharmacovigilance activities would allow a further better characterization of the safety profile of drugs used in clinical practice.