OBJECTIVE To analyze the characteristics and regularity of the adverse reaction (ADR) induced by traditional Chinese medicine (TCM) formula granules and provide a reference for monitoring the ADR of TCM formula granules.

METHODS  Relevant literature from CNKI, Wanfang, VIP, and PubMed from December 2001 to October 2022 were retrieved for ADRs induced by TCM formula granules for further statistical and descriptive analysis. In addition, the clinical application of TCM formula granules in 9 medical institutions in Heilongjiang Province was investigated.

RESULTS Forty-four studies were selected, involving 1580 cases (n=26780) of ADRs of TCM formula granules. Its clinical application was mostly based on the combination (addition or subtraction) of prescriptions. ADR primarily involved the gastrointestinal system (42.6%), skin and its appendages (24.5%) and cardiovascular system (21.3%). Most clinicians and pharmacists agreed to monitor the ADR of TCM formulations, but there was a lack of reporting and assessment methods.

CONCLUSION In clinical practice, attention should be paid to the characteristics of the occurrence of adverse reactions of formula granules, strengthen the research on the monitoring mechanism of adverse reactions, and establish a scientific method for the safety evaluation of formula granules and TCM tablets to ensure the safe and effective use of medicines by patients.