ArticleRenal failure2025
Post-marketing safety profile and clinical prioritization of adverse events with avacopan in ANCA-associated vasculitis: a FAERS pharmacovigilance analysis.
Article in Renal failure, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed.
- Real-world long-term outcomes and safety of avacopan for antineutrophil cytoplasmic antibody-associated vasculitis with advanced renal dysfunction: a multicenter cohort study (4U-AAV Study).Clinical and experimental nephrology · 2026Article
- Avacopan-Associated Hepatotoxicity: Clinical Signal, Liver Injury Patterns, and Plausible Mechanisms.Cureus · 2026Review
- Real-world safety assessment of avacopan in patients with antineutrophil cytoplasmic antibody-associated vasculitis.RMD open · 2026Article
- Infection-related and Hepatobiliary Death Outcome Reports Involving Avacopan in the Japanese Pharmacovigilance Database.In vivo (Athens, Greece)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.