Avacopan, a novel C5a receptor inhibitor, offers therapeutic potential for ANCA-associated vasculitis. This study assessed its post-marketing safety using the FDA Adverse Event Reporting System (FAERS) from Q4 2021 to Q4 2024. Disproportionality analyses identified 75 adverse events (AEs) potentially linked to avacopan, with hepatobiliary disorders and infections being most prominent. A total of 62 AEs were classified as having moderate clinical priority, including drug-induced liver injury, renal failure, and deafness. Subgroup analysis revealed age- and sex-based differences in AE patterns. Logistic regression indicated that older age and concomitant use of rituximab or proton-pump inhibitors increased the risk of hepatobiliary AEs. These findings highlight the need for close monitoring of hepatic function and infection risk during avacopan therapy. Further research is warranted to explore the underlying mechanisms and potential drug interactions.
Keywords: ANCA-associated vasculitis; Avacopan; FAERS; drug-induced liver injury; pharmacovigilance; post-marketing safety.