Disproportionality analysis of drug-induced erectile dysfunction using FAERS database

Abstract

This study employs a comprehensive approach to systematically identify drugs associated with Drug-Induced Erectile Dysfunction (DIED) risk and constructs a DIED risk assessment platform. Utilizing the FAERS database, we identified “Erectile Dysfunction,” “Organic Erectile Dysfunction,” and “Psychogenic Erectile Dysfunction” as relevant Preferred Terms (PTs) for DIED. After excluding patients diagnosed with Erectile Dysfunction (ED), drugs suspected as primary suspects (PS) in ≥ 10 DIP events were selected as target drugs. Through disproportionality analysis, we identified positive signals for these drugs using ROR, PRR, BCPNN, and EBGM. We further assessed the independent effects of positive drugs by adjusting for confounding factors such as age using multivariate logistic regression. Subsequently, we obtained the median onset time and outcome events of DIED for target drugs and compared them by age. The DIED platform is accessible for free at http://116.196.73.86:3838/ADR-DATABASE/DIED/. A total of 67 target drugs were identified as PS in DIED events with 10 or more cases. Based on disproportionality analysis, we further identified 28 drugs with DIED risk signals. Multivariate logistic regression revealed that 23 of these drugs were independent risk factors for DIED (OR > 1 and P < 0.05). Analysis of outcome events showed a significant difference in the median onset time of DIED between different age groups. This study identified 28 drugs associated with DIED risk. We also found some previously unreported DIP risk drugs, including omeprazole, antihypertensive drugs, etc., which should be of clinical concern.