Phosphodiesterase-5 inhibitors and hearing impairment: a disproportionality analysis using the US food and drug administration adverse event reporting system

Abstract

ABSTRACT Background This study aimed to investigate the association between phosphodiesterase-5 inhibitors (PDE-5i) and hearing impairment adverse events (HIAEs) while providing an overview of the characteristics of drug-related HIAEs. Research design and methods We conducted a detailed pharmacovigilance analysis using data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database, covering 2004 to 2022. By calculating the reporting odds ratio (ROR) and the information component (IC), we identified signals that indicate the association between PDE-5i use and HIAEs. Results Among the 191,398 reports related to PDE-5i, we identified 2,608 cases of HIAEs. Signals were observed for both PDE-5i monotherapy and polytherapy, indicating combinations of drugs. Avanafil exhibited the strongest signal (ROR: 4.35, 95% CI: 2.56–7.41, IC: 2.09, 95% CI: 0.10–3.51), while vardenafil showed the weakest signal (ROR: 2.69, 95% CI: 2.21–3.28, IC: 1.14, 95% CI: 0.74–2.04). Sildenafil had the highest reported cases (ROR: 3.03, 95% CI: 2.82–3.24, IC: 1.57, 95% CI: 1.34–1.80). Conclusion These findings highlight a significant correlation between PDE-5i use and HIAEs, emphasizing the need for careful evaluation in clinical practice and providing appropriate guidance to patients before initiating treatment.