Real-world safety profile of opicapone: a comprehensive pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) database.

This study provides a real-world analysis of opicapone, a peripheral, selective, and reversible COMT inhibitor approved as adjunctive therapy to levodopa/carbidopa for managing 'off' episodes in Parkinson's disease, utilizing the FDA Adverse Event Reporting System (FAERS) data from April 2016 to September 2024. We conducted disproportionality analyses using four established pharmacovigilance algorithms: the Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), Proportional Reporting Ratio (PRR), and Multi-item Gamma Poisson Shrinker (MGPS). Our analysis identified 950 adverse event (AE) reports where opicapone was the primary suspected drug, comprising 91 preferred terms of AEs across 24 system organ classes (SOCs). The analysis revealed significantly higher AE incidence rates among male patients (55.67% vs 44.33%, n = 300) and elderly populations (> 65 years: 74.6% vs ≤ 65 years: 25.4%, n = 252), with common AEs including weight decreased, hypotension/syncope, elevated blood creatine kinase, constipation, and dyskinesia. Notably, unexpected AEs not listed in opicapone's label were discovered, such as miosis, eyelid ptosis, anosmia, and so on. The concomitant use of opicapone and levodopa/carbidopa was associated with an elevated reporting rate of AEs. This study underscores the necessity of robust post-marketing surveillance to monitor the safety of opicapone in real-world settings. Our findings contribute novel insights into its AE profile and highlight potential risks associated with its concomitant use with levodopa/carbidopa, providing valuable evidence to guide clinical decision-making and risk mitigation strategies.