Page 100 - 2025中醫藥與天然藥物聯合學術研討會-中醫藥與天然藥物的挑戰Ｘ機遇與未來大會手冊

Safety Surveillance and Adverse Event Reporting of Taiwanese Herbal

Medicine

1
Y u -An Yeh, Hung-Rong Yen* ,2,3,4,5

1 Division of Chinese Traumatology, Department of Chinese Medicine, China Medical
University Hospital, Taichung, 40447, Taiwan. yuanyeh112@gmail.com
2 Division of Integrated Chinese and Western Medicine, Department of Chinese Medicine,
China Medical University Hospital, Taichung, 40447, Taiwan
3 Chinese Medicine Research Center, China Medical University, Taichung, 40402, Taiwan
4 Research Center for Traditional Chinese Medicine, China Medical University Hospital,
Taichung, 40447, Taiwan
5 School of Chinese Medicine, College of Chinese Medicine, China Medical University,
Taichung, 40402, Taiwan

* E-mail: hungrongyen@mail.cmu.edu.tw

Abstract
Adverse reactions to Taiwanese herbal medicine (THM) are increasingly recognized in
integrative medicine. While often perceived as “natural and safe,” certain herbs and formulas

may cause systemic toxicity or interact with conventional drugs. This study reviews evolving
definitions of adverse drug reactions, clinical manifestations, and pharmacovigilance data from
Taiwan’s Chinese Medicine Safety Monitoring System (2001–2024). Five representative cases
illustrate these risks: Aconitum carmichaeli Debx. (Fuzi) causing palpitations; misidentified
Trichosanthes kirilowii Maxim. root (Tianhuafen) leading to gastrointestinal toxicity; Shen

Tong Zhu Yu Tang combined with aspirin resulting in purpura; Salvia miltiorrhiza Bunge
(Danshen) with dabigatran producing oral bleeding; and Ephedra sinica Stapf (Mahuang)
overdose associated with excitability and insomnia. Reported adverse events primarily involved

cardiovascular, gastrointestinal, hematologic, and neurologic systems, with causality ranging
from possible to probable (WHO-UMC, Naranjo criteria). These findings underscore the need
for vigilance in THM safety, with priorities including monitoring intrinsic herbal toxicities,
enforcing botanical identification and quality control, and recognizing herb–drug interactions,
particularly with anticoagulants and antiplatelets. Careful dosage regulation of concentrated

extracts and individualized risk assessment considering comorbidities and polypharmacy are
equally essential. To ensure safe integration of THM into modern healthcare, robust
pharmacovigilance systems, standardized adverse event reporting, and interdisciplinary

collaboration remain critical.

Keywords: Taiwanese herbal medicine (THM); Adverse drug reaction (ADR);
Pharmacovigilance; Herb–drug interaction; Botanical identification; Dosage safety

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