Abstract

Objectives: Tonifying herbal medicines are used to nourish and balance the body’s qi, blood, yin, and yang, targeting deficiencies. They are the second most frequently used category by consumers visiting Korean medicine clinics, following prescriptions for back pain. This study aimed to analyze the adverse events associated with herbal medicine products classified as tonics through a national pharmacovigilance database. Methods: We investigated 11 types of tonifying herbal medicine products (466 product codes) in the Korea Adverse Event Reporting System (KAERS) database from 2012 to 2021. Extracted adverse event reports were analyzed based on information of reports, patient demographics, classification of adverse events, reported herbal medicine products, and causality assessment results. Results: A total of 31 individual case safety reports were identified, covering 33 adverse events. The annual number of reports has increased over the study period. Most reports were filed by physicians and pharmacists, with the majority of patients being adults or elderly. Gastrointestinal disorders were the most frequently reported adverse events, accounting for 48.5% of cases. Of the 33 adverse events, 93.9% were classified as non-serious, while 6.1% were classified as serious. The most frequently reported herbal medicine products were Bojungikgi-tang, Yukmijihwang-tang, and Palmijihwang-tang. Conclusions: Although the study found that adverse events associated with tonifying herbal medicine products are generally not serious, it highlights the importance of systematic monitoring and reporting. The findings underscore the need for improved adverse event reporting systems within traditional Korean medicine to ensure patient safety and guide future research.