TY  -  JOUR
AU  -  di Mauro, Gabriella
AU  -  Zinzi, Alessia
AU  -  Vitiello, Francesco
AU  -  Restaino, Martina
AU  -  Sportiello, Liberata
AU  -  Rafaniello, Concetta
AU  -  Sullo, Maria Giuseppa
AU  -  Capuano, Annalisa
T1  -  Adverse drug reactions and gender differences: what changes in drug safety?
PY  -  2019
Y1  -  2019-09-01
DO  -  10.1723/3245.32145
JO  -  The Italian Journal of Gender-Specific Medicine
JA  -  Ital J Gender-Specific Med
VL  -  5
IS  -  3
SP  -  114
EP  -  122
PB  -  Il Pensiero Scientifico Editore
SN  -  2612-3487
Y2  -  2026/05/04
UR  -  http://dx.doi.org/10.1723/3245.32145
N2  -  Summary. 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 outcomes. 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-specific 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 (Italy), in terms of number and severity. In line with literature data, our results showed a higher number of reports involving 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.
ER  -