The Safety Profiles of Avacopan on Microscopic Polyangiitis and Granulomatosis with Polyangiitis: A Real-World Pharmacovigilance Analysis
October 2025
in “
Frontiers in Immunology
”
Studysummary In this study, researchers analyzed adverse events linked to avacopan using FDA data, finding no high-priority safety concerns but identifying five potential new adverse events, including alopecia, primarily among American patients, and noting a higher risk of liver dysfunction in Japanese patients.
Our plain-language summary. Not medical advice or a treatment recommendation. Consult a qualified healthcare professional before changing treatment. Full disclaimer
This study analyzed 1,128 avacopan-related adverse event reports from the FDA Adverse Event Reporting System to assess the drug's safety profile. Thirty-three adverse event signals were identified, including known issues like nausea and fatigue, and five new potential adverse events such as alopecia and increased appetite. No high-priority adverse events were found, indicating a favorable safety profile for avacopan. Notably, alopecia was observed exclusively in American patients, and Japanese patients had a higher risk of liver dysfunction. The median time to adverse event onset was 86.5 days, with most occurring within the first month of treatment. These findings support the safe use of avacopan and provide a basis for future research and safety management.
