JAMA Network Open

Although they have known limitations, spontaneous reporting pharmacovigilance databases like the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and World Health Organization VigiBase are widely cited as evidence for claims that women experience adverse drug events (ADEs) at as high as twice the rate of men. Pharmacokinetics and pharmacodynamics are typically used to explain these sex differences; however, many factors could influence the distribution of ADE reports by sex, including well-known disparities in the rates at which men and women use prescribed drugs. This study examined ADEs reported by sex in the FAERS database after adjusting for drug use by men and women.

Rushovich, Tamara*, Annika Gompers*, Jeffrey W. Lockhart*, Ife Omidiran, Steven Worthington, Sarah S. Richardson, and Katharine M. N. Lee (* denotes equal authorship). 2023. “Adverse Drug Events by Sex After Adjusting for Baseline Rates of Drug Use.” JAMA Network Open 6(8):e2329074.