OBJECTIVE： To analyze the regularity and characteristics of ADE induced by Tanreqing injection， and to lay the foundation for ADE mechanism study. METHODS： Using “Tanreqing injection” and “ADE” as keywords， the literatures about ADE induced by Tanreqing injection were retrieved from CJFD， VIP， CBM and Wanfang database during Jan. 1st， 2014 to Oct. 30th， 2018. Patient’s gender， age， drug allergy history， primary diseases， drug dosage， solvent， organs or systems involved， main clinical manifestation of ADE， occurrence time， drug combination were all analyzed statistically. RESULTS： A total of 126 literatures were included， involving 1 577 patients. There were 906 male （57.45％） and 671 female （42.55％）； the age ranged from 6 months to 98 years old， of which 625 cases （39.63％） were aged from 0 to 10 years. Among 1 577 patients， primary diseases of 537 patients were recorded and mainly were bronchitis and pneumonia （323 cases， 60.15％）. Drug dosages of 687 patients were recorded， among which there were 612 cases of normal dose （89.08％）， 75 cases of off-label dose （10.92％）. 779 cases of solvent （mainly containing 5％ Glucose injection or 0.9％ Sodium chloride injection， 715 cases， 91.78％）. 1 960 case times of ADE were recorded， mainly including lesion of skin and its appendents （930 case times， 47.45％）， followed by systemic response （231 case times， 11.79％）， digestive system （221 case times， 11.28％） and cardiovascular system （220 case times， 11.22％）. Occurrence time of ADE was recorded in 1 172 cases， mainly 10-30 min after medication （434 cases）. Detailed drug use was recorded in 1 356 patients， among which there were 521 cases of drug combination， mainly containing antibiotics， followed by TCM injection for clearing away heat and toxic material and antiviral drugs， etc. CONCLUSIONS： Attention should be paid to ADE induced by Tanreqing injection. On the one hand， ADE monitoring should be strengthened to summarize， analyze and evaluate ADE； on the other hand， attention should be paied when patients have above situations， so as to promote rational and effective clinical measures and to ensure drug safety of patients.