Abstract: Objective To discuss the general characteristics of the ADRs induced by Shenqifuzhen injection, provide reference for rational drug use in clinic. Methods The China Hospital Knowledge Database(CHKD) and Chinese Medical Journal Database(CMJD) were searched to get the cases of the adverse drug reactions induced by Shenqifuzhen injection that reported from 1999 to 2012, then statistical analysis was conducted. Results Among the 21 ADR cases, the proportions of the male and female patients were 80.95% and 19.05%. Most of the ADRs induced by Shenqifuzhen injection occurred within 30 minutes after medication. The skin and adnexa damage(22%) and circulatory system damage(20%) occupied the major part in ADR cases. The original diseases of the patients who had ADR are mainly cancer. Ten patients received combination therapy. Only one patient has allergic history. The treatment and prognosis of adverse drug reactions is good. Conclusion Attention should be paid to the characteristics of adverse drug reactions induced by Shenqifuzhen injection in clinical use, and the monitoring of medication should also be strengthened to ensure the safe medication.

Key words: Shenqifuzhen injection, adverse drug reaction, literature analysis