Abstract: Objective To analyze the risk of lysine acetylsalicylate for injection in china, in order to provide reference for clinical rational drug use. Methods The individual adverse drug reaction cases in WHO Vigilyze and China adverse drug reaction database, domestic literatures, and the domestic risk management measures were analyzed. Results The Data from WHO VigilyzeTM, China adverse drug reaction database and domestic literatures showed that the serious adverse drug reactions related to anaphylactic shock, severe cutaneous damage, and use of medicines in children were the major risks of lysine acetylsalicylate. Conclusion We should reinforce the safety monitoring of lysine acetylsalicylate for injection, timely update the drug labeling and promote the rational application of medicine.

Key words: lysine acetylsalicylate, anaphylactic shock, pediatric usage, labeling