Evolving trends and drug class dynamics in drug-induced fatty liver disease over two decades

Drug-induced fatty liver disease (DIFLD) is increasingly recognized as a critical adverse drug reaction, with potential progression to liver fibrosis, cirrhosis, and liver failure. Using FAERS reports from 2004 to 2023, the study analyzed trends in steatotic liver disease (SLD) and liver failure associated with various drugs, stratifying by therapeutic class, age, sex, and region.

A total of 15,269 SLD cases were reported, rising from 481 in 2004 to 1,413 in 2023, with adults aged 18–64 and females being the most affected populations. Monoclonal antibodies (MAbs), antipsychotics, and disease-modifying antirheumatic drugs (DMARDs) were the most frequently implicated drug classes, with MAbs showing the fastest increase in cases (+11.77/year). Adalimumab was the single drug most often associated with DIFLD (5.81%). Regional differences were observed, with the U.S. reporting 45.44% of cases.

This work provides a comprehensive overview of evolving drug-related risk patterns in DIFLD, emphasizing the importance of pharmacovigilance, demographic awareness, and targeted preventive strategies to optimize patient safety.