Exploring the Contributions of Gendered Social Factors to Sex Disparities in Adverse Drug Events

Concerns about large sex disparities in adverse drug events (ADEs, a term referring to all reported adverse events in people taking medication, including both confirmed adverse drug reactions [ADRs] and spontaneously reported, unconfirmed adverse events) have been a priority for policymakers and were a primary motivation for new policies, implemented over the past decade, requiring the study and reporting of sex differences in preclinical research (Arnegard et al., 2020; Clayton & Collins, 2014; Heidari et al., 2016). Such policies, intended to redress historical sex disparities in medical research, are often taken to imply that sex disparities in ADEs are primarily explained by sex-specific biology, but this inference leaves underexplored the role of gendered social factors in the experience and reporting of ADEs. Consistent with the 2025 National Academies of Sciences, Engineering, and Medicine report A New Vision for Women's Health Research, which emphasized the importance of a women's health research focus on both sex and gender and the need to “[c]reate pathways to facilitate and support innovative and transformative research for women's health” (National Academies of Sciences, Engineering, and Medicine, 2025), the investigation of gendered social factors could bring fresh insight into the causal pathways driving disparities in ADEs.