Gender/Sex and Adverse Drug Events

Unpacking the popular claim that women are more biologically vulnerable to drug side effects — drawing on a multi-year GenderSci Lab research program, summarized in Women's Health Issues.

Key terms

Access the Youtube video here.

  • Any harmful or unintended effect that occurs during or after use of a medication.

  • The U.S. Food and Drug Administration's database of voluntarily reported adverse drug events, widely used as a data source in ADE research despite known reporting biases.

  • The underlying rate at which a given population (e.g., women vs. men) uses a particular drug at all; failing to adjust for this can make a group appear to have more ADEs simply because they take more medication overall, not because they're more biologically susceptible.

  • The GenderSci Lab's proposed alternative to purely biological explanations: that social and structural factors — drug use patterns, dosing research history, care-seeking behavior, reporting practices — meaningfully contribute to observed sex/gender disparities in ADEs.

  • A term the GenderSci Lab uses to signal that gender and sex are deeply entangled and often cannot be cleanly separated in observed health data.

Discussion Questions

  1. Before watching, had you heard the claim that women are more vulnerable to drug side effects? Where had you encountered it?

  2. Explain in your own words why simply comparing raw counts of adverse drug events between women and men can be misleading.

  3. What social or behavioral factors does the video suggest might explain part of the ADE gap, beyond biological sex differences?

  4. The lab distinguishes a "sex disparity" from a "gender disparity." Why might that distinction matter for how doctors, regulators, or journalists talk about drug safety?

  5. If you were redesigning drug safety reporting systems today, what would you want researchers to track that isn't currently standard?

Suggested Readings

  1. Gompers, Annika, Tamara Rushovich, Sarah S. Richardson, and Katharine M. N. Lee. “Exploring the Contributions of Gendered Social Factors to Sex Disparities in Adverse Drug Events”. Women’s Health Issues, 2026.

  2. Lee, K.M.N., Rushovich, T., Gompers, A., Boulicault, M., Worthington, S., Lockhart, J., & Richardson, S.S., (2023). A Gender Hypothesis of sex disparities in adverse drug events.Social Science & Medicine, 339. 

  3. Rushovich, T., Gompers, A., Lockhart, J.W., Omidiran, I., Worthington, S., Richardson, S.S., & Lee, K.M.N., (2023). Adverse Drug Events by Sex After Adjusting for Baseline Rates of Drug Use. JAMA Network Open, 6(8).

  4. Zhao, H., DiMarco, M., Ichikawa, K., Boulicault, M., Perret, M., Jillson, K., Fair, A., DeJesus, K.D., & Richardson, S.S., (2023). Making a ‘sex-difference fact’: Ambien dosing at the interface of policy, regulation, women’s health, and biology. Social Studies of Science.

Frequently Asked Questions

  • Yes — no prior background in gender/sex, clinical trial design, or pharmacology is required. It works well as a stand-alone assignment in intro gender studies, feminist science studies, health policy, or biomedical ethics courses.

  • Pharmacoepidemiology, biostatistics, public health, sociology of medicine, science & technology studies (STS), and gender studies.

  • The FDA Adverse Event Reporting System (FAERS), matched against national drug use survey data (the Medical Expenditure Panel Survey) for the years 2014–2019.

  • The research shows that after adjusting for how much more medication women use on average, the disparity in reported ADEs is much smaller than commonly assumed — suggesting drug use patterns, not sex biology alone, drive much of the original gap.

Suggested Citations

SUGGESTED VIDEO CITATION

GenderSci Lab. (2026). The Role of Gender in Understanding Adverse Drug Events [Video]. YouTube. https://www.youtube.com/watch?v=RCymF7cYwKs.

SUGGESTED WEBPAGE CITATION

GenderSci Lab. (2026). Gender/Sex and adverse drug events. https://www.genderscilab.org/sex-and-adverse-drug-events.