OBJECTIVE:To probe into the application of pharmacoepidemiology in safety study of TCM injection for sale in order to provide new idea for the study of TCM injection for sale. METHODS:Based on reported ADR events caused by TCM injection in recent year,the main approaches of pharmacoepidemiology were introduced to analyze the safety of TCM injection for sale. RESULTS & CONCLUSION:Pharmacoepidemiology is the main mean for safety study of TCM injection for sale and important basis for the selection of essential drug in China. Descriptive study can provide testimony for countermeasure in the early stage of ADR and analytical study can be used for the selection and detection of etiological hypothesis. Many other methods of pharmacoepidemiology can be used as approaches for safety study of TCM injection for sale.