A real‐world pharmacovigilance study of FDA adverse event reporting system events for sildenafil

Abstract Background Sildenafil, a selective inhibitor of phosphodiesterase type 5 (PDE5), is widely used for the treatment of erectile dysfunction (ED). However, the safety profile of sildenafil, including adverse event (AEs), requires comprehensive evaluation. Methods This retrospective pharmacovigilance study aimed to evaluate AEs linked to sildenafil by analyzing data sourced from the FDA Adverse Event Reporting System (FAERS) database. A case/non‐case design was utilized, and various algorithms including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multiitem gamma Poisson shrinker (MGPS) were employed to measure the signals indicating the presence of sildenafil‐related AEs. Results Among 339,230 reports, 33,692 specifically mentioned sildenafil use. Most of AEs occurred in males over 60 years old. The United States accounted for the highest proportion of reported AEs. Severe outcomes, including death, disability, and life‐threatening events, were reported. Significant system organ class (SOC) included “Reproductive system and breast disorders” (SOC: 10038604), “Neoplasms benign, malignant and unspecified” (SOC: 10038738), “Vascular disorders” (SOC: 10047065), and “Blood and lymphatic system disorders” (SOC: 10005329). Noteworthy preferred terms (PTs) associated with sildenafil included “Vision blurred,” “Flushing,” “sudden hearing loss,” “Painful erection,” and “Priapism.” Unexpected AEs, such as “Malignant melanoma,” “Pulmonary hypertension,” “Malignant melanoma in situ,” “Pulmonary arterial hypertension,” “Metastatic malignant melanoma,” “Malignant melanoma stage III,” “Malignant melanoma stage II,” “Acquired hemophilia,” “Aortic dissection rupture,” and “Intracranial artery dissection” were also identified. Conclusions These findings emphasize the importance of monitoring and understanding the potential risks associated with sildenafil. Further investigation is warranted to validate these associations and address previously unrecognized safety concerns.