Abstract: Objective To analyze adverse drug reactions (ADRs) of lappaconitine hydrobromide, and provide reference for clinical rational use. Methods The data of Shandong province from January 2004 to February 2018 on National Adverse Drug Reaction Monitoring System was retrieved and the data was analyzed. Results There are totally 1 101 cases of ADRs included in the analysis. The most common ADRs caused by lappaconitine hydrobromide were skin and appendages disorders(23.31%), gastrointestinal disorders(17.62%), neurological disorders(15.85%) and respiratory disorders(15.68%). 97 cases of severe ADRs were reported, mainly containing chest tightness, palpitations, dyspneas, rigors and hyperpyrexias. Besides, we found overdose and dissolvent mismatch in clinic. Conclusion The labelling of lappaconitine hydrobromide remains to be supplemented and perfected. Clinicians should strictly follow the instructions in terms of usage and dosage. When the lappaconitine hydrobromide was given by infusion, menstruum should be sufficient and away from light.

Key words: lappaconitine hydrobromide, adverse reactions, clinical application