Abstract: Objective To investigate the mechanism and provide suggestions for the pharmacovigilance and rational use of traditional Chinese medicine with cardiac therapeutic effect and possible cardiac injury. Methods Traditional Chinese medicines with "potency-toxicity: bi-directional effect of the heart was Systematically search and excavatd from Chinese periodical literature databases such as CNKI, Weipu, Wanfang Data Knowledage Service Platform. The retrieval time was from inception to November 30, 2021. Analyze the components, mechanisms, transformation factors of "potency-toxicity" effect of these medicines by combining bibliometric and bioinformatics tools. Results 10 Chinese herbs, such as Shandougen (Sophorae Tonkinensis Radix Et Rhizoma), Wuzhuyu (Euodiae Fructus), Maidong (Ophiopogonis Radix), Liangmianzhen (Zanthoxyli Radix) and Xiangjiapi (Periplocae Cortex), had cardiac "potency-toxicity” bi-directional effect. The types of bi-directional components include alkaloids, cardiac glycosides, saponins, etc. The mechanism of bi-directional effects is mainly related to the AKT/AMPK/mTOR pathway and myocardial Ca²⁺-Na⁺-K⁺ channels. The potency-toxicity effect conversion is related to the patient's pre-existing heart disease, physical differences, drug dosage, administration and combination, as well as potency-toxicity components and other factors. Conclusion The administration of cardiac potency-toxicity bi-directional effect traditional Chinese medicines requires multiple measures of pharmacovigilance to prevent the conversion of such medicines from potency to toxicity, especially to enhance the attention to the medication monitoring of patients with pre-existing cardiac diseases.

Key words: Wuzhuyu (Euodiae Fructus), Maidong (Ophiopogonis Radix), Liangmianzhen (Zanthoxyli Radix), Xiangjiapi (Periplocae Cortex), heart, potency-toxicity bi-directional effect, mechanism analysis, pharmacovigilance