Abstract: Objective To analyze the adverse drug reactions (ADR) induced by misoprostol,find out about the characteristics of such ADR and to provide technical support for safe clinical application of misoprostol.Methods Data on ADR of misoprostol between 2003 and 2018 was provided by Beijing Adverse Drug Reaction Monitoring Center.Statistical analysis was performed on the basic information of patients with ADR,types of ADR,involved system-organ and clinical manifestations,and outcomes.Results A total of 668 reports of ADR were included in the analysis.ADR mainly manifested themselves in gastrointestinal diseases,systemic diseases,skin and its appendage diseases,and nervous system diseases.There were a total of 5 cases of severe ADR,including one case of death,in which anaphylactic shock was observed.Conclusion Most of the patients who reported ADR were females who used misoprostil for abortion purposes.This indicates the need to strengthen the safe and rational use of misoprostol in clinic.Pharmaceutical care and intervention should be carried out for high-risk groups to make clinical medication safe,proper and effective.

Key words: misoprostol, adverse drug reaction, medication safety