To ensure drug safety of Xingxue  Shuxuening injection by optimizing the risk management plan based on the drug’s manufacture, preclinical safety and post-marketing safety researches.Methods：strict quality control was applied to original medicinal materials selection and production, conducted toxicology and safety research on Xingxue Shuxuening injection, analyzed adverse drug reaction (ADR) data collected from spontaneous reporting system (SRS), clinical drug administration data from hospital information system (HIS), large-scale prospective clinical safety research, briefly introduced drug risk management plan and implementation. Results：The post-marketing randomized controlled trials did not have ADR related to organs and blood system reported; published study reports and SRS suggested the drug may cause skin rashes, itching, dizziness, vomiting, phlebitis, etc; HIS data showed that Shuxuening injection (including other varieties of data) and blood urea nitrogen (BUN) changes may be co-related which still need further validation. Moreover, patients who has allergies history were more likely to have allergic reaction after taken Shuxuening injection (P<0.001); an ongoing proactive safety research will eventually reveal ADR occurrence and influencing factors. Conclusion： Xingxue Shuxuening injection can be safely applied in clinical under proper drug risk management.