ArticleFrontiers in pharmacology2026
Detection of adverse event signals associated with key immunosuppressants for autoimmune hepatitis: insights from the food and drug administration adverse event reporting system database.
Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: 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. Methods: 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. Results: 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. Conclusion: 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.
Indexed as
Identifiers
What OpenQuestion holds
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.