Objective: To investigate and analyze the characteristics and regularities of 932 children with adverse drug reactions (ADR) induced by Xiyanping injection

and provide references for promoting clinical rational drug use in children. Methods: Retrospective method was adopted

statistical analysis was conducted on 932 cases of ADR induced by Xiyanping injection from the database of Shandong Provincial Center for ADR monitoring from 2015 to 2017. Results: Among the 932 ADR reports

568 cases were male (60.94%)

364 cases were female (39.06%)

yet the difference was not statistically significant (P>0.05). The incidence of ADR in infants was the highest

with 364 cases (39.06%) aged from 0 to 1 year old

and 250 cases (26.82%) aged >1 to 3 years old. ADR occurred in 461 cases (49.46%) within 30 minutes. Intravenous drip was the main administration route

totally 896 cases (96.14%). Nine hundred and thirty-two cases of ADR involved multiple systems/organs

totally 1

320 cases

and the most common clinical manifestation was skin and its accessory lesions (937 cases

70.98%). There were 77 cases (8.26%) of severe ADR and 224 cases (24.03%) of drug combination. Conclusion: It is necessary to strengthen the rational clinical use of Xiyanping injection

grasp the clinical indications

and reduce the incidence of adverse drug reactions as much as possible.