A Real-World Disproportionality Analysis of Avacopan in Anti-Neutrophil Cytoplasmic Antibodies Associated Vasculitis: Insights From FDA Adverse Event Reporting System

The study conducted a real-world disproportionality analysis of Avacopan using data from the FDA Adverse Event Reporting System from 2022 to 2025, involving 3,529 individual case safety reports. It identified significant adverse events, including neutropenia, leukopenia, lymphopenia, deafness, diarrhea, nausea, and liver-related issues such as liver disorder and drug-induced liver injury. Notably, alopecia, venous thromboembolic events, and cholestatic hepatic reactions emerged as new signals not listed in current labels. The findings underscore the importance of post-marketing surveillance and suggest potential updates to Avacopan's safety profile, highlighting the need for further regulatory and clinical scrutiny.