Drug-Related Rhabdomyolysis: A Real-World FDA Adverse Event Reporting System Database Study

Background Drug-induced rhabdomyolysis is one of the major causes of non-traumatic rhabdomyolysis. This adverse reaction poses challenges to patient safety and places a substantial burden on public health systems. Aim Based on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, this study systematically analyzes the association between drugs and rhabdomyolysis, providing scientific evidence for improving clinical drug safety management and optimizing pharmacovigilance systems. Method By cleaning and filtering FAERS data from 2004 to 2024, a total of 865,934 rhabdomyolysis cases were analyzed out of 18,278,243 reports. Four signal detection methods—Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS)—were employed for adverse event signal analysis. Additionally, regression models were used to further identify drugs closely associated with rhabdomyolysis. Results By combining disproportionality analysis methods and logistic regression, this study identified 16 drugs significantly associated with rhabdomyolysis. Among them, aprotinin (ROR = 131.87), multivitamins and minerals (ROR = 940.60), and sodium phosphate (ROR = 40.35) posed the highest risks. Antiviral drugs and cardiovascular medications constituted the major components of drug-induced rhabdomyolysis, with average onset times of 594.17 days and 1434.21 days, respectively. Conclusion This study revealed significant associations between various drugs and rhabdomyolysis, providing valuable references for drug safety management. Future efforts should focus on enhanced monitoring and clinical interventions for high-risk drugs to optimize pharmacovigilance systems and improve patient outcomes.