To evaluate the adverse reactions of Reduning Injection in clinical application and to analyze its clinical safety.Methods:The commonly used Chinese databases for computer retrieval were:China China National Knowledge Infrastructure(CNKI),China Science Periodical Database(CSPD),Chinese Citation Database(CCD),and common English databases:PubMed,Cochrane Library,Web of Science.We searched for publicly published hot topics:the clinical randomized controlled trial of Reduning Injection,from the establishment of the database to April 2020.A total of 2 researchers independently searched and screened the literature according to the inclusion and exclusion criteria,extracted information,and evaluated the quality.RevMan 5.3 software was used for statistical analysis.Meanwhile,the incidence of adverse reactions of different control drugs,different medication days,and different age groups was analyzed in subgroups.Results:In the end,a total of 36 papers(37 studies) met the inclusion criteria,with a total sample size of 3 917 cases.Meta-analysis showed that the incidence of adverse reactions of Reduning Injection(3.50%) was lower than that of the control group(11.84%).The difference was statistically significant(RR=0.31,95%CI 0.24 to 0.40,Z=9.07,P<0.000 01).Subgroup analysis showed that in the ribavirin subgroup(P<0.000 01),the duration of treatment≤5 d subgroup(P<0.000 1) and >5 d subgroup(P=0.000 5),and the child subgroup(P<0.000 01),the incidence of adverse reactions of Reduning Injection was significantly lower than that of the control group.The effectiveness analysis showed that,compared with ribavirin(P<0.000 01),Yanhuning(P=0.01),Tanreqing(P=0.02),Shuanghuanglian(P=0.001),ceftriaxone(P=0.01),the effective rate of Reduning Injection was significantly higher than that of the control group.Conclusion:Compared with ribavirin,Reduning Injection has a lower incidence of clinical adverse reactions and better efficacy; compared with Yanhuning and Tanreqing,it has better clinical efficacy but no significant advantage in safety.