Comprehensive pharmacovigilance analysis of belumosudil: A real-world study using the FDA adverse event reporting system (FAERS)

Belumosudil is a first-in-class ROCK2 inhibitor approved by the the US Food and Drug Administration (FDA) in 2021 for treatment of chronic graft-versus-host disease (cGVHD). With its growing clinical use, a comprehensive understanding of its real-world safety profile is essential. In this study, we assessed adverse events (AEs) associated with belumosudil by analyzing data from the publicly available Food and Drug Administration Adverse Event Reporting System (FAERS) database, offering valuable insights for clinical safety. The AEs report data of belumosudil were collected from the FAERS database covering the period from the third quarter of 2021 to the fourth quarter of 2024. The association between belumosudil and AEs was investigated by utilizing four algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). Additionally, the Weibull distribution was used to model the risk of AEs over time. A total of 1964 cases associated with belumosudil were identified, comprising 5765 AE reports. Adverse reactions documented on the drug label, such as fatigue, nausea, infection, pneumonia, and rash. Additionally, potential adverse reactions not mentioned on the label were also identified, including inappropriate schedule of product administration, product use in unapproved indication, stomatitis, dry eye, cataract, depressed mood, emotional disorder, and neuropathy peripheral. The median onset time of belumosudil‑associated AEs was 66 days (interquartile range [IQR] 23–155 days), and the majority of the AEs occurred within the first 30 days after belumosudil initiation. In conclusion, we preliminarily explores the real-world safety of belumosudil, identifying both known adverse reactions and new potential AE signals. These findings provide valuable support for clinical monitoring and risk identification of belumosudil.