Unveiling Hidden Risks: A Comprehensive Analysis of Drug-Induced Cholestasis from FAERS Data
Abstract
progression. This study aimed to identify the most commonly associated medications linked to cholestasis using data from the FDA Adverse
Event Reporting System (FAERS). Methods: We analyzed FAERS data spanning from the first quarter of 2004 to the second quarter of 2024.
Using the Medical Dictionary for Regulatory Activities (MedDRA), we identified reports of cholestasis and conducted disproportionality analyses, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN),
and empirical Bayesian geometric mean (EBGM), to assess risk signals related to cholestasis and its causative drugs. As well, Weibull shape
parameter was used to calculate the timing of cholestasis induced by drugs. Results: Our analysis identified a total of 16, 420 adverse event
reports pertaining to cholestasis. Acetaminophen accounted for the majority of cases (454 reports). Disproportionality analysis indicated that
the medications with the highest RORs were rifampin, piperacillin/tazobactam, and amoxicillin/clavulanic acid. Differences in the drugs associated with cholestasis were noted across various age and gender subgroups. Additionally, the adverse reactions leading to cholestasis were
characterized as early failures. Conclusion: These findings underscore the importance of enhancing the identification and management of
drug-induced cholestasis, especially when multiple medications are used concurrently, as this may increase the risk of this adverse effect.
Keywords
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DOI: http://dx.doi.org/10.70711/mhr.v3i1.9007
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