Abstract: Objective To analyze the risk of Sodium Aescinate for injection, so as to provide reference for clinical use safety. Methods The individual ADR (adverse drug reaction) cases in China adverse drug reaction database, domestic literatures, and the risk management measures by NMPA were analyzed. Results Data analysis showed that, the ADR of the Rash, pruritus, phlebitis, anaphylactic shock, liver damage et al. induced by Sodium Aescinate for injection and the risk of medication for children and the elderly should be concerned in clinical use and take relevant prevention and control measures. Conclusion Marketing authorization holders should take risk control measures such as revising the drug instructions for the identified risks and actively carry out post market study; hospitals should strengthen the rational use of drugs to avoid the occurrence of adverse reactions; institutions of monitoring and evaluation of adverse drug reactions should continuously strengthen the monitoring of adverse reactions to ensure the safety of drug users.

Key words: Sodium Aescinate for injection, adverse drug reaction, literature analysis, regulatory measure