Objective To observe the characteristics and influential factors of adverse reactions（ ADRs） of Reduning Injection（ 热毒宁注射液）. Methods The application information of Reduning Injection（ 热毒宁注射液） was collected in 5 hospitals. The nested case-control design was conducted by taking ADRs as the outcome indicators and univariate and multivariate Logistic regression model was used to analyze the possible influential factors of ADRs of Reduning Injection（ 热毒宁注射液）. Results The ADRs occurred in 16 patients（ 11 males and 5 females） among 3 000 patients

mostly children and with an average age of 10. 12 years old. The ADRs mainly manifested by gastrointestinal symptoms such as abdominal pain

diarrhea and stomachache

accounting for 87. 5%. Sixty-four patients without ADRs were matched at a ratio of 1 to 4 by taking the same age and sex as a matching condition. A multivariate Logistic regression analysis showed that drip rate was an influential factor of ADRs（ P = 0. 043） and syringe cleaning was an important factor of ADRs（ P = 0. 027）. Conclusion The ADRs of Reduning Injection（热毒宁 注射液） commonly occur in children and the important factors are unwashed syringe before the injection and rapid drip.