OBJECTIVES: Phosphodiesterase type 5 (PDE-5) inhibitors are often used as a first-line therapy for erectile dysfunction (ED). This study identifies characteristics of adverse events (AEs) and any potential safety signals associated with PDE-5 inhibitors used for ED from a post-marketing safety surveillance program.

METHODS: A descriptive analysis was conducted for all AEs reported to the FDA Adverse Event Reporting System (FAERS) for four PDE-5 inhibitors (avanafil, sildenafil, tadalafil, and vardenafil) indicated for ED between January 2010 and June 2022. The frequency of reported outcomes and the most reported AEs were found. A disproportionality analysis using proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) was also conducted for the most common and clinically important AEs.

RESULTS: A total of 29,176 AEs were reported for the PDE-5 inhibitors indicated for ED in the FAERS database during the study period. The average age of patients was 58.79 years. The most reported outcomes were other serious events with 6,707 events (67.21%) and hospitalization with 1,947 events (19.51%). The most reported AE was ‘drug ineffective,’ with 6,994 reports (23.97%). Seven safety signals were detected across the drugs. For sildenafil, a key safety signal was ‘death’ (PRR 3.19 [2.51, 4.04], ROR 3.24 [2.55, 4.11], IC 0.51). For tadalafil, key signals were ‘hearing loss/impairment’ (PRR 2.50 [1.97, 3.18], ROR 2.53 [1.99, 3.22], IC 0.68) and ‘priapism’ (PRR 3.62 [2.11, 6.23], ROR 3.64 [2.12, 6.26], IC 0.86). For vardenafil, ‘drug administration error’ (PRR 3.33 [2.27, 4.89], ROR 3.39 [2.29, 5.02], IC 1.61) was an important signal.

CONCLUSIONS: PDE-5 inhibitors demonstrate significant increased risks of reporting certain clinically important AEs. While these events are rare, it is imperative to continually monitor PDE-5 inhibitor use at the primary care to national surveillance levels to ensure safe utilization.