Abstract: Objective To analyze the characteristics and causes of adverse reactions (ADR) caused by traditional Chinese medicines (TCM) among lactating women, and propose targeted measures for pharmacovigilance and prevention. Methods Such databases as CNKI, Wanfang Data, VIP, CBM and PUBMED were searched to collect related literature that was published between January 1, 1964 and August 31, 2020 about the ADR caused by TCM among lactating women. The basic information about the patients, organs/systems involved in adverse reactions, clinical manifestations and Outcomes were statistically analyzed. The correlations between the four characters (FC), five tastes (FT) and channel distributions of the TCM involved in ADR were analyzed via SPSS 23.0. Results In this study, 31 pieces of literature and 34 cases of ADR were included, involving 23 types of TCM, 6 proprietary Chinese medicines and 5 compound medicines. The organs/systems involved were manifested in gastrointestinal damage, damage to the skin and its attachments, and damage to the central and peripheral nervous systems. The main causes of ADR included patients’ individual differences, toxicity reactions, irrational drug use such as self-medication, improper clinical syndrome differentiation, misallocation, improper drug processing, and improper decoction. Conclusion TCM can cause varied safety problems during lactation, ranging from nausea and vomiting, through skin rash in babies, to hemorrhagic shock, renal failure, permanent breast closure in lactating women. It is recommended that pharmacovigilance should be strengthened in terms of treatment principles and drug selections for women during lactation. Furthermore, close monitoring is required after medication to promote the safety and rationality of TCM for lactating women.

Key words: lactation, traditional Chinese medicine (TCM), adverse drug reactions, literature analysis, Chinese medicine pharmacovigilance