OBJECTIVE： To observe the characteristics and influential factors of aderverse drug reactionl （ADR） induced by Reduning injection. METHODS： The clinical information of pediatric patients receiving Reduning injection were collected from pediatric department of our hospital during Nov. 2014-Oct. 2015. Using ADR as outcome indicators， case control in the queue design was conducted. The influential factors of ADR induced by Reduning injection were analyzed by using binary univariate and multivariate Logistic regression analysis， Cox regression fitted 1 ∶ 3 matching Logistic regression analysis. RESULTS： Of 9 187 cases， the average age of children was （4.21±2.63） year-old； there were 23 ADR cases， with the incidence of 0.25％. There were 21 cases of rash （9 cases of combined pruritus） and 2 severe ADR cases （including 1 case of twitching limbs， blue complexion， peripheral cold， high fever， leg pain and 1 case of limbs cold and high fever）； 23 cases of ADR symptoms finally disappeared after treated. Based on drug dose and usage of low concentrations and low drip rate in our hospital， regression analysis showed that age， sex， drug dose， solvent amount， concentration， drip rate， source of children， drug combination， the group number of daily continuous intravenous infusion， infusion order， the days of continuous medication and other factors were not statistically significant （P＞0.05）； the incidence of ADR induced by Reduning injection was 0.11％ in the group of 1-3 years old children and was 0.31％ in the group of 3-16 years old children. There was no statistical significance between 2 groups （P＞0.05）. CONCLUSIONS： The reasons for ADR induced by Reduning injection might be the drug itself， the wrong methods， etc. Reasonable drug dosage， low concentration， low drip rate， using sophisticated filters infusion device and changing infusion device while dressing can reduce the occurrence of ADR.