Medications Most Commonly Associated With Erectile Dysfunction: Evaluation of the Food and Drug Administration National Pharmacovigilance Database.

Background: Erectile dysfunction (ED) is an adverse effect of many medications.

Aim: We used a national pharmacovigilance database to assess which medications had the highest reported frequency of ED.

Methods: The Food and Drug Administration Adverse Event Reporting System (FAERS) was queried to identify medications with the highest frequency of ED adverse event reports from 2010 to 2020. Phosphodiesterase-5 inhibitors and testosterone were excluded because these medications are often used as treatments for men with ED. The 20 medications with the highest frequency of ED were included in the disproportionality analysis.

Outcomes: Proportional Reporting Ratios (PRRs) and their 95% confidence intervals were calculated.

Results: The 20 medications accounted for 6,142 reports of ED. 5-α reductase inhibitors (5-ARIs) and neuropsychiatric medications accounted for 2,823 (46%) and 2,442 (40%) of these reports respectively. Seven medications showed significant levels of disproportionate reporting with finasteride and dutasteride having the highest PRRs: 110.03 (103.14-117.39) and 9.40 (7.83-11.05) respectively. The other medications are used in a wide variety of medical fields such as cardiology, dermatology, and immunology.

Clinical Implications: Physicians should be familiar with these medications and understand their respective mechanisms of action, so that they may counsel patients appropriately and improve their quality of life.

Strengths And Limitations: The strength of the study is its large sample size and that it captures pharmacologic trends on a national level. Quantitative and comparative "real-world" data is lacking for the most common medications associated with ED. The limitation is that the number of reported events does not establish causality and cannot be used to calculate ED incidence rates.

Conclusion: In a national pharmacovigilance database, 5-ARIs and neuropsychiatric medications had the highest reports of ED adverse effects. There were many other medications used in a variety of medical fields that were also associated with ED. Kaplan-Marans E, Sandozi A, Martinez M, et al. Medications Most Commonly Associated With Erectile Dysfunction: Evaluation of the Food and Drug Administration National Pharmacovigilance Database. Sex Med 2022;10:100543.