Safety risk analysis of urapidil injection

LI Shuiting; WANG Fang; WANG Kun; LIU Yongli; ZHANG Gangping; BI Xueyan

Abstract：Objective:To analyze the safety risk of urapid injection and provide reference for clinical safe and ration-al drug use.Methods:The characteristics and clinical manifestations of adverse reactions of urapidil injection reported by medical institutions and holders in Hebei Province from December 1,2007 to June 30,2024 were summarized and an-alyzed.The adverse drug reactions reported in the literature database of China HowNet from January 1,2000 to June 30,2024 were sorted out.Results:From December 1,2007 to June 30,2024,a total of 192 cases of uradier injection ad-verse reactions,including 3 6 cases of new adverse reactions(1 8.7 5%),and 4 0 cases of severe adverse reactions(20.83%).192 cases of adverse reactions occurred after use within the specified dosage and administration.and the symptoms were relieved or disappeared within 24 hours after drug withdrawal or symptomatic treatment.Conclusion:Urapidil injection can cause serious adverse reactions such as anaphylaxis.It is necessary to pay attention to its clinical application and take appropriate preventive and therapeutic measures.Drug marketing licensees should strengthen the main responsibility of monitoring and evaluation of adverse reactions,improve the safety information of urapidil injec-tion specifications in a timely manner.