Pharmacovigilance Signal Detection of Drug-Induced Hospitalizations and Mortality: A 5-Year Nationwide Study

Background/Objectives: This study aimed to comprehensively characterize the prevalence and patterns of drug-induced hospitalizations and death and to identify predictors strongly associated with drug-induced death. Methods: This study analyzed 29,438 serious adverse event (SAE) reports submitted to the Korea Adverse Event Reporting System (KIDS KAERS DB) database between January 2019 and December 2023. Disproportionality analysis was conducted to detect drug-event associations, and multiple logistic regression was performed to identify independent predictors of mortality. Results: Mortality accounted for 7.53% (n = 2217) and hospitalization for 93.53% (n = 27,532). The strong signals for drug-induced death were observed with steroids (ROR 3.81, 95% CI 3.39-4.27), antidotes (ROR 3.65, 95% CI 2.15-6.18), and anticoagulants (ROR 2.01, 95% CI 1.73-2.34). Immunosuppressants (ROR 9.17, 95% CI 4.75-17.70), diuretics (ROR 3.83, 95% CI 1.42-10.31), and antihyperlipidemics (ROR 3.65, 95% CI 1.72-7.69) were strongly associated with hospitalizations. In multivariate regression, men, aging (OR 1.02, 95% CI 1.02-1.03), use of antidotes (OR 11.37, 95% CI 6.59-19.62), steroids (OR 5.78, 95% CI 4.71-7.08), and anticoagulants (OR 3.60, 95% CI 2.90-4.46) were independent predictors of drug-induced mortality. Conclusions: This study emphasizes the need for targeted surveillance and risk-mitigation strategies focusing on anticoagulants, steroids and immunosuppressants, particularly among elderly and multimorbid populations.