A Gender Hypothesis of Sex Disparities in Adverse Drug Events

The study analyzed over 33 million records from the FDA Adverse Events Reporting System (FAERS) to explore sex disparities in adverse drug events (ADEs) through the Gender Hypothesis. It found that women report more ADEs than men, particularly in patient-reported cases and non-severe outcomes, while serious ADEs were more frequently reported in males. The study identifies four pathways through which gender influences ADE reporting: healthcare utilization, clinical bias, subjective experience of adverse events, and upstream social determinants of health. The findings suggest that addressing gendered social factors could help mitigate sex disparities in ADEs, highlighting the need for nuanced research designs and more precise gender/sex categories in health datasets.