Abstract: Objective To investigate the incidence of adverse drug reactions and clinical symptoms of Zhengqingfengtongning sustained release tablets. Methods 4 064 cases of patients who used Zhengqingfengtongning sustained release tablets were collected (including outpatients and inpatients from 7 hospitals in Hunan province). The frequency and constituent ratio were described by SPSS software. The incidence rate of different affecting factors was compared by chi-square test. Results The incidence of Zhengqingfengtongning sustained release tablets adverse events was 4.75% (193 in 4 063). The main ADR/ADE damages involved skin and its accessories (41.23%), gastrointestinal system (35.53%). The clinical symptoms of ADR were various, of which the erythra and itching occurred the most. Conclusion The lesions of skin and its accessories and gastrointestinal system are the predominant presentation of ADRs of Zhengqingfengtongning sustained release tablets. Clinicians should be familiar with the common ADRs of Zhengqingfengtongning sustained release tablets, discover and deal with the ADRs in time in order to ensure clinical drug safety.

Key words: Zhengqingfengtongning sustained release tablet, sinomenine, adverse drug reaction(ADR)