OBJECTIVE:To probe into the characteristics and causes of adverse drug reactions/adverse drug events（ADR/ADE） induced by Shuxuening injection

so as to provide suggestions for preventing the security issues of Shuxuening injection.METHODS:Relevant literature of security issues induced by Shuxuening injection were retrieved from CNKI

Wangfang Med Online and VIP database from Feb.1999 to Feb.2019.Retrospective study and statistical methods were used to sort out and summarize the ADR/ADE of Shuxuening injection.RESULTS:Fifty literature reports on the safety of Shuxuening injection were collected

including 74 cases.The ratio of male to female was 1 ∶1.24;the proportion of patients ≤ 60 years was relatively high

with a total of 47 cases（63.51%）.ADR/ADE induced by Shuxuening injection mostly appeared as immediate hypersensitivity occurred within 30 minutes after administration

totally 46 cases（62.16%）.Multiple organs and（or） systems were involved in Shuxuening injectioninduced ADR/ADE

mainly manifested as respiratory system

systemic damage

circulation system

skin and appendages.CONCLUSIONS:The possible security issues should be prevented when using Shuxuening injection

so as to improve the level of rational drug use.