Comprehensive analysis of adverse events associated with pimavanserin using the FAERS database.

ABSTRACT

OBJECTIVE: Pimavanserin, a novel 5-HT2A receptor antagonist, has been approved for the treatment of Parkinson's disease psychosis (PDP). This study aims to conduct a comprehensive analysis of the adverse events (AEs) of pimavanserin by analyzing the FDA's Adverse Event Reporting System (FAERS) database. METHODS: AE reports related to pimavanserin in the FAERS database from the second quarter of 2016 to the fourth quarter of 2023 were mined. Signal detection methods, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM), were employed to identify and classify AEs. RESULTS: The study collected 12,839,687 AE reports, with 30,997 reports primarily suspecting pimavanserin, identifying 166 Preferred Terms (PTs) across 27 System Organ Classes (SOCs). The data showed that males reported more frequently than females, with the highest reporting in patients aged 75 and above. Reports increased over time, with a significant rise in 2023 compared to 2016. Major categories of AEs included hallucination, death, product dose omission issue, and confusional state, with death being notably the second most reported issue. Strong and new potential AEs were identified, including sleep-related issues like somnolence, insomnia, and sleep talking; cognitive and behavioral issues such as alexithymia, belligerence, and aggression; dose-related issues like prescribed underdose and underdose; and other AEs like nonspecific reactions. CONCLUSION: This study reveals potential AEs of pimavanserin, including sleep disorders and cognitive changes, underscoring the importance of careful monitoring and personalized treatment in managing PDP.