OBJECTIVE： To explore the incidence， clinical manifestations and influential factors of ADR induced by Xuebijing injection， and to provide reference for safe and rational use of it. METHODS： The inpatients who used Xuebijing injection in our hospital during Jan. 2012 to Dec. 2016 was registered and monitored centrally， and analyzed statistically in respects of clinical characteristics， occurrence time of ADR， clinical manifestation， outcome， etc. RESULTS： A total of 3 300 patients records were included， involving 81 ADR cases with incidence of 2.45％. There was no correlation between ADR and gender. The incidence of ADR was in high level in the patients with age over 60 years （6.53％）， history of allergy （72.84％）， original diseases as respiratory disease （3.33％）， blood system disease （3.11％） and central nervous system disease （3.03％）， and receiving combination of TCM injection （34.57％）， antibiotics （25.93％） and immune enhancer （14.81％）. Single-day culmulative amount with no more than 50 mL had relatively higher proportion （36.67％）， and there was no statistical significance in the ADR with different single-day culmulative amounts （P＞0.05）. 38.27％ of ADR occurred within 30 min after first medication. Organs/systems involved in ADR were mainly skin and its appendants （37.04％）， cardiovascular system （19.75％） and gastrointestinal system （14.81％）. Totally 15 cases had severe ADR， which were mainly anaphylactic shock （33.33％，5/15） and systemic rash （20.00％，3/15）. All ADR were recovered after drug withdrawal or symptomatic treatment. CONCLUSIONS： ADR induced by Xuebijing injection are mainly anaphylactic type. The incidence of ADR is higher in patients with primary respiratory disease， blood system disease， drug combination， allergic history and advanced age.  The part of them are not mentioned in drug package inserts. Manufacturers are suggested to collect ADR information and improve drug package insets in time.