Analysis of Adverse Events Associated with Kyeongok-go Using Korea Adverse Event Reporting System (KAERS) Data

Objective: Kyeongok-go, a traditional Korean herbal medicine composed of honey, Rehmanniae Radix Preparata, Poria, and Ginseng Radix , is widely used as a tonic.This study analyzed adverse events (AEs) associated with Kyeongok-go using postmarketing surveillance data.Methods: We analyzed 143 individual case safety reports (ICSRs) related to Kyeongok-go from the KIDS KAERS DB (2205A0042) covering a 10-year period (2012-2021) in KIDS.Descriptive statistics were used to characterize patient demographics and AE patterns.Disproportionality analysis was performed using proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC) to detect safety signals.Safety signals were defined as PRR 2, ROR 2 with IC 95% confidence interval lower limit >0.Results: Kyeongokgo production value increased from 2.11 billion KRW (2012) to 29.7 billion KRW (2021) with corresponding increases in ICSRs from 4 to 47 cases annually.A total of 216 AEs were reported from 143 ICSRs.The most frequent AEs were gastrointestinal disorders (93 cases, 43.1%), including diarrhea, abdominal discomfort, and dyspepsia, followed by skin and subcutaneous tissue disorders (41 cases, 19.0%).Disproportionality analysis identified significant safety signals for diarrhea, pyrexia, hypersensitivity, erythema, and flushing.Most AEs were non-serious (96.3%).Conclusion: This study provides comprehensive safety information on Kyeongok-go based on post-marketing surveillance data.Gastrointestinal disorders, particularly diarrhea, and fever were identified as characteristic safety signals for Kyeongok-go.Enhanced awareness among healthcare providers and consumers regarding these potential AEs is needed to promote safe use of Kyeongok-go.(PeRM 2025;17:175-186)