Objective: To investigate the characteristics and rules of severe adverse drug reactions (ADR) in a children’s hospital

so as to promote the rational drug use in the clinic. Methods: Severe ADR reported in the hospital from 2017 to 2019 were collected

and related factors such as age

gender

route of administration and drug categories were statistically analyzed. Results: Of the 132 cases of severe ADR

85 cases were males (64.39%) and 47 cases were females (35.61%). The route of administration in 121 cases of severe ADR was intravenous administration

10 cases were oral administration

and 1 case was spray. Among the 132 cases of severe ADR

anti-infective drugs accounted for the highest proportion (47.73%)

followed by glucocorticoids (9.09%)

vitamins and nutritional support drugs (6.06%)

and traditional Chinese medicine injections (6.06%). One hundred and thirty-two cases of severe ADR mainly involved skin and its accessory damage

followed by systemic damage. Conclusion: Clinical attention should be paid to the monitoring and reporting of severe ADR in children

especially anti-infective drugs

glucocorticoids

vitamins and nutritional support drugs and traditional Chinese medicine injections

so as to further standardize the safe and rational drug use in children