Objective To research the clinical safety and adverse reaction（ADR） of Reduning Injection（热毒宁 注射液） and provide the basis for clinical medication safety. Methods Totally 3000 inpatients and outpatients with infectious diseases used Reduning Injection（热毒宁注射液） were centrally monitored from September 2012 to October 2013. The clinical features and suspected drugs in patients with ADRs were recorded in detail. Results The incidence of ADR was 0. 53%（16 /3 000）. The patients with ADRs mainly manifested as abdominal pain

diarrhea

stomachache and allergies. There were 11 males and 5 females. There were 14 infants and children aged below 9

accounting for 87. 50%. The ADRs often occurred within（0. 68 ± 0. 44） h after medication. The average days of medication were（3. 44 ± 1. 86） d from the beginning of medication to the occurrence of ADR. The patients with ADRs were discontinued and four patients were treated with dexamethasone. The symptoms were relieved or disappeared after discontinuation. Conclusion The ADRs of Reduning Injection（ 热毒宁注射液） are occasional and mainly with manifestation of digestive symptoms

skin lesions and systemic allergic reactions. The ADRs of Reduning Injection often occur in infants and children and within 3h of medication. The children medication and combination with antimicrobials should be monitored.