Evidence mapPaperPMID 39922875Full record

ArticleScientific reports2025

Real-world pharmacovigilance study of drug-induced autoimmune hepatitis from the FAERS database.

Bu-Kun Zhu, Si-Ying Chen, Xiang Li, Shu-Yun Huang, Zhan-Yang Luo, Wei Zhang

Abstract read
In one paragraph

Article in Scientific reports, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Bu-Kun Zhu *Department of Infection, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
Si-Ying Chen *Anxi County Hospital, Quanzhou, 362400, China.
Xiang Li *Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, 201399, China.
Shu-Yun HuangDepartment of Infection, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
Zhan-Yang LuoShanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, 201399, China. shutcm2015lzy@163.com.
Wei ZhangDepartment of Infection, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China. 18918104444@189.cn.

Funding

Shanghai University of Traditional Chinese Medicine 20224Y0162
6 · The paper itself

Abstract

This study aims to identify and evaluate the most common drugs associated with the risks of autoimmune hepatitis (AIH) using the FDA Adverse Event Reporting System (FAERS) database. Adverse drug events (ADEs) associated with drug-induced AIH (DI-AIH) were retrieved from the FAERS database (January 2004-June 2024). Disproportionality analysis was performed to identify drugs significantly linked to DI-AIH, and time-to-onset (TTO) analyses were conducted to evaluate the timing and risk profiles of DI-AIH adverse reactions. Our study identified 2,511 ADEs linked to autoimmune hepatitis. Disproportionality analysis identified 22 drugs significantly associated with AIH risk, including 4 antibiotics, 3 antivirals, 4 cardiovascular drugs, 5 antitumor agents, 2 immunomodulators, 2 nonsteroidal anti-inflammatory drugs, and 1 drug each from the respiratory and nervous system categories. The highest DI-AIH risks were observed with minocycline (ROR = 53.97), nitrofurantoin (ROR = 57.02), and doxycycline (ROR = 16.12). Antitumor drugs had the shortest median TTO (77.00 days), whereas cardiovascular drugs exhibited the longest (668.30 days). Through a comprehensive analysis of the FAERS database, our study identified drugs strongly associated with AIH. Preventing DI-AIH requires careful drug selection and monitoring. This study provides evidence-based insights into implicated drugs, aiming to optimize clinical management and mitigate risks.

Indexed as

Adverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsHepatitis, AutoimmunePharmacovigilanceAdultAgedAnti-Bacterial AgentsAnti-Inflammatory Agents, Non-SteroidalAntineoplastic AgentsDatabases, FactualFemaleHumansMaleMiddle AgedUnited StatesUnited States Food and Drug AdministrationAnti-Bacterial AgentsAnti-Inflammatory Agents, Non-SteroidalAntineoplastic AgentsAdverse drug eventsDisproportionality analysisDrug-induced autoimmune hepatitisFAERSPharmacovigilance

Identifiers

PMID39922875
PMCPMC11807099

What Socratic holds

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Registered trials

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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 Socratic graph.