Abstract: Objective To analyze the risk of bromhexine hydrochloride injections in China, so as to provide reference for clinical rational drug use. Methods The individual adverse drug reaction cases in WHO Vigilyze and China Adverse Drug Reaction Database, domestic literatures, and the domestic and foreign risk management measures were analyzed. Results The risk of serious allergic reaction and use of medicines in children should be concerned. Conclusion We should strengthen the clinical application monitoring of bromhexine hydrochloride injections, timely update the drug labeling and promote the rational application of medicine.

Key words: bromhexine hydrochloride, allergic reaction, pediatric usage, labeling