Detection of adverse event signals associated with key immunosuppressants for autoimmune hepatitis: insights from the food and drug administration adverse event reporting system database.

Authors

Luyuan Ma, Yize Fan, Ruolan Gu, Ziyue Li, Yuexia Liu, Kaixuan Zhang, Xiaochao Gao, Caiyan Zhao

Published in

Frontiers in pharmacology. Volume 17. Pages 1889345. Epub Sep 24, 2026.

Abstract

Autoimmune hepatitis (AIH) requires long-term immunosuppressive therapy, yet the comparative safety profiles of key drugs remain incompletely characterized. The objective of this study was to conduct a systematic evaluation of the adverse drug event (ADE) signals associated with glucocorticoids, specifically dexamethasone, methylprednisolone, and prednisolone, in addition to azathioprine and mycophenolate mofetil, in the treatment of AIH.
Disproportionality analysis was performed on ADE reports from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database, covering the most recent data available from the first quarter of 2004 through the fourth quarter of 2024. Reporting odds ratios (RORs), proportional reporting ratios (PRRs), and Bayesian confidence propagation neural network metrics were calculated to identify significant ADE signals. Stratified analyses examined demographic and reporting factors influencing ADE patterns.
Among 720 reports, females accounted for a higher proportion of ADE reports (62.9%). Infections and gastrointestinal disorders were predominant signals across therapies. Glucocorticoid monotherapy showed strong SOC signals for infections, endocrine disorders, and metabolism and nutrition disorders, with opportunistic infections at the PT level. Azathioprine monotherapy exhibited gastrointestinal and neoplasm signals, alongside drug intolerance. Glucocorticoid-azathioprine showed gastrointestinal, infection, and drug intolerance signals; glucocorticoid-mycophenolate mofetil linked to infections. Mycophenolate mofetil monotherapy exhibited medication management failures. Stratified analyses revealed higher ADE reporting frequencies in females, patients ≥65 years, and differential reporting patterns by occupation.
This study identified distinct ADE profiles for AIH therapies. These findings underscore the need for personalized monitoring strategies to mitigate treatment-specific ADEs in AIH management.

PMID:
42851367
Bibliographic data and abstract were imported from PubMed on 09 Oct 2026.

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