Abstract: ObjectiveTo study the general pattern and characteristics of adverse drug reactions/events(ADR/ADE) induced by sofren injection to provide references for clinical rational use of drug. Methods719 cases of ADR/ADE related to the sofren injection from January 2004 to December 2014 in Jilin province were analyzed using retrospective study method. ResultsAmong 719 reports, the elderly accounted for 44.78%, the main ADR/ADE was systemic damage (36.92%), and the major clinical manifestations were anaphylactic shock, dyspnea, shiver and fever, etc, but there was no warning of these in the drug instructions. ConclusionIt's important to pay attention to the ADR/ADE caused by sofren injection, and perfect drug instructions, in order to improve rational use of medicines in clinic, ensure clinical medication safety.

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