Real-World Pharmacovigilance Analysis of Drug-Induced Liver Injury in 18-60 Years: Based on the FDA Adverse Event Reporting System (FAERS)

Drug-induced liver injury (DILI) in adults aged 18–60 years remains understudied despite its clinical heterogeneity and rising incidence. This study aimed to characterize the epidemiology, risk factors, and drug-specific profiles of DILI in this demographic. Utilizing data from the FDA Adverse Event Reporting System (FAERS) (2007–2024), we analyzed 17,464 DILI cases. Four disproportionality methods—Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS)—were employed to identify high-risk drugs. Time-to-onset (TTO) and gender-specific risks were assessed. Seventeen drugs exhibited significant DILI signals. Rifampicin (ROR=19.33, 95%CI: 16.41–22.77), amoxicillin/clavulanic acid (ROR=16.39, 95%CI: 14.48–18.56), and paracetamol (ROR=10.3,95%CI: 9.61–11.04) showed the strongest associations. Non-steroidal anti-inflammatory drugs (NSAIDs) had the shortest median time-to-onset (7 days). Gender subgroup analysis revealed sex-biased hepatotoxicity, with females disproportionately affected by immunosuppressants and males by antibiotics. This large-scale real-world analysis identifies NSAIDs, antibiotics, and immunosuppressants as critical hepatotoxic threats in younger adults. The findings advocate for targeted hepatic monitoring and updated drug labeling to reflect class-specific latency patterns. Gender-tailored risk mitigation strategies are warranted to address sex-based disparities in DILI susceptibility.