Characteristics and risk factors of serious adverse drug reactions in older patients using the Korea Adverse Event Reporting System data: a retrospective observational study
- Author:
Minkyung OH
1
Author Information
- Publication Type:Original article
- From: Journal of Yeungnam Medical Science 2025;42(1):66-
- CountryRepublic of Korea
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Abstract:
Background:Older adults are vulnerable to adverse drug reactions (ADRs) owing to physiological changes, comorbidities, and polypharmacy. Nationwide evidence in Korean is limited. This study aimed to describe the characteristics of ADRs and identify the risk factors for serious outcomes using the Korea Adverse Event Reporting System (KAERS).
Methods:KAERS reports from 2005 to 2015 were analyzed. Eligible cases were patients aged ≥65 years with causality assessed as certain, probable, or possible for orally administered drug. Serious ADRs were defined according to International Conference on Harmonization E2A and World Health Organization-Uppsala Monitoring Centre criteria. Descriptive statistics, chi-square tests, logistic regression, and disproportionality analyses were performed.
Results:Of the 889,997 ADR reports, 118,023 involved older patients (mean age 73.6 years; 57.9% female). Organ disorders included gastrointestinal, skin, and nervous system disorders. The common drug classes were analgesics, antimicrobials, and antituberculosis drugs. Overall, 6.1% of ADRs were serious, mainly involving the hepatic and biliary systems, respiratory, and bleeding/coagulopathy. The highest proportions of serious ADRs involved antineoplastic and antithrombotic agents. In multivariable analysis, male sex was independently associated with serious outcomes (adjusted odds ratio, 1.33; 95% confidence interval, 1.24–1.43), while age group was not. Disproportionality analysis identified notable drug-organ class signals, including antimicrobials associated with application site disorders and antineoplastic agents associated with disorders.
Conclusion:Serious ADRs comprised 6.1% of reports in older Koreans. Antineoplastic and antithrombotic agents were strongly associated with serious outcomes and male sex was an independent risk factor. These results indicate a need for safer prescriptions and improved pharmacovigilance for older patients.
