Abstract: Objection To explore the general characters of the adverse drug reactions/events caused by Xiyanping injection． Methods By retrospective study method, we analyzed the 270 spontaneous reports of adverse drug reaction/event collected by Center for ADR Monitoring of Fujian from 2004 to 2011. Results Among 270 reports,children aged under 14 years old accounted for 83.4%(225/270). The main adverse reactions/events were damage to skin and its attachment, and the major clinical manifestations were rash, urticaria, etc. Severe reaction could result in anaphylactic shock, allergic purpura, etc. Conclusion Xiyanping injection should be used strictly in accordance with the instructions of medication, and the process of medication should be monitored, in order to reduce or avoid ADR/ADE.

Key words: Xiyanping injection, adverse drug reaction/event, analysis