Real-world pharmacovigilance study of drug-induced autoimmune hepatitis from the FAERS database
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 (...
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Nature Portfolio
2025-02-01
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| Series: | Scientific Reports |
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| Online Access: | https://doi.org/10.1038/s41598-025-89272-x |
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| author | Bu-kun Zhu Si-ying Chen Xiang Li Shu-yun Huang Zhan-yang Luo Wei Zhang |
| author_facet | Bu-kun Zhu Si-ying Chen Xiang Li Shu-yun Huang Zhan-yang Luo Wei Zhang |
| author_sort | Bu-kun Zhu |
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| description | 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. |
| format | Article |
| id | doaj-art-d1025a70962f441890f9fb36e690ea4e |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Nature Portfolio |
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| spelling | doaj-art-d1025a70962f441890f9fb36e690ea4e2025-02-09T12:29:32ZengNature PortfolioScientific Reports2045-23222025-02-0115111110.1038/s41598-025-89272-xReal-world pharmacovigilance study of drug-induced autoimmune hepatitis from the FAERS databaseBu-kun Zhu0Si-ying Chen1Xiang Li2Shu-yun Huang3Zhan-yang Luo4Wei Zhang5Department of Infection, Longhua Hospital, Shanghai University of Traditional Chinese MedicineAnxi County HospitalShanghai Pudong Hospital, Fudan University Pudong Medical CenterDepartment of Infection, Longhua Hospital, Shanghai University of Traditional Chinese MedicineShanghai Pudong Hospital, Fudan University Pudong Medical CenterDepartment of Infection, Longhua Hospital, Shanghai University of Traditional Chinese MedicineAbstract 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.https://doi.org/10.1038/s41598-025-89272-xFAERSDrug-induced autoimmune hepatitisAdverse drug eventsDisproportionality analysisPharmacovigilance |
| spellingShingle | Bu-kun Zhu Si-ying Chen Xiang Li Shu-yun Huang Zhan-yang Luo Wei Zhang Real-world pharmacovigilance study of drug-induced autoimmune hepatitis from the FAERS database Scientific Reports FAERS Drug-induced autoimmune hepatitis Adverse drug events Disproportionality analysis Pharmacovigilance |
| title | Real-world pharmacovigilance study of drug-induced autoimmune hepatitis from the FAERS database |
| title_full | Real-world pharmacovigilance study of drug-induced autoimmune hepatitis from the FAERS database |
| title_fullStr | Real-world pharmacovigilance study of drug-induced autoimmune hepatitis from the FAERS database |
| title_full_unstemmed | Real-world pharmacovigilance study of drug-induced autoimmune hepatitis from the FAERS database |
| title_short | Real-world pharmacovigilance study of drug-induced autoimmune hepatitis from the FAERS database |
| title_sort | real world pharmacovigilance study of drug induced autoimmune hepatitis from the faers database |
| topic | FAERS Drug-induced autoimmune hepatitis Adverse drug events Disproportionality analysis Pharmacovigilance |
| url | https://doi.org/10.1038/s41598-025-89272-x |
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