Risk Assessment of the Top 60 Drugs for Drug-Related Sexual Dysfunction: A Disproportionate Analysis from the Food and Drug Administration Adverse Event Reporting System
August 2025
in “
The Journal of Sexual Medicine
”
Studysummary This retrospective pharmacovigilance study identified 34 drugs, including finasteride and dutasteride, that may be associated with sexual dysfunction, with a higher risk observed in males aged 31-45.
Our plain-language summary. Not medical advice or a treatment recommendation. Consult a qualified healthcare professional before changing treatment. Full disclaimer
The study by Lihua Wu and colleagues analyzed 61,722 cases of drug-related sexual dysfunction (SD) using the FDA adverse event reporting system, identifying a disproportionate number of reports linking the top 60 drugs to SD. Finasteride, dutasteride, and silodosin were found to have the highest risk signals. Males aged 31-45 were particularly at risk, and 34 specific drugs, including finasteride and sertraline, were significant risk factors. The study developed a risk model with a predictive accuracy of 0.791 and highlighted that 24 drugs did not indicate SD risk in their instructions, suggesting incomplete safety information. The findings underscore the need for healthcare providers to monitor and manage drug-related SD to improve patient outcomes, although causality could not be established due to the study's retrospective nature.
