Risk assessment of the top 60 drugs for drug-related sexual dysfunction: a disproportion analysis from the Food and Drug Administration adverse event reporting system

Background Although several drugs are associated with sexual dysfunction (SD), the SD-related risks of most drugs are not yet known. Aim Our study will evaluate the risk signals of adverse drug event (ADE) that may be associated with SD in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database to promote rational clinical drug use. Methods SD-related drugs were examined using reporting odds ratio (ROR), proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker. The top 60 drugs were identified based on the reported frequency and signal intensity. Univariate and multivariate regression analyses were used to explore the risk factors for drug-related SD. Outcomes The signal intensity between drug and SD was evaluated by signal detection method. Results In total, 79 022 SD-related ADEs were identified, including 61 722 patients. The patients included 40 273 males (65.25%) and 17 777 females (28.80%), with more adults aged 18-65 years (52.29%). The three drugs with the highest ROR risk signals were finasteride (ROR [95% CI]: 212.3 [204.74-220.13]), dutasteride (ROR [95% CI]: 29.11 [26.84-31.56]), and silodosin (ROR [95% CI]: 21.81 [17.94-26.52]). Multivariate regression analysis showed that male, age 31-45 years, and 34 drugs including finasteride were risk factors for drug-related SD. Clinical implications Our findings emphasize the importance of the effects of drugs on SD and provide a reference point for further research on the pathogenesis of drug-related SD. Strengths and limitations Our study is the first to explore the potential association between medications and SD ADE using the FAERS database. However, as this study was a retrospective observational pharmacovigilance study, the causality could not be further assessed. Conclusion We identified 34 drugs that may be related to SD, with a predominance in the nervous system. This finding suggests that clinicians should be aware of the risk of SD associated with these drugs.