OBJECTIVE： To investigate the occurrence of ADR induced by Shuxuening injection in Beijing area， and to provide reference for rational drug use in clinic. METHODS： ADR induced by Shuxuening injection in Beijing area during 2003-2013 was classified statistically in respects of population， organs/systems involved in ADR， clinical manifestations， occurrence time， drug combination and prognosis. RESULTS： Of 1 648 ADR cases， the incidence of ADR in the elderly patients was higher than young patients， and that of female patients （60.92％） was higher than that of male patients （39.14％）. Multiple organs/systems were involved in Shuxuening injection-induced ADR， and top 3 were nervous system （422 cases， 21.33％）， skin and its appendants （411 cases， 20.78％） and others （305 cases， 15.42％）. Clinical manifestations were skin rash， itching， dizziness and nervousness， palpitation， arrhythmia， etc. ADR mostly occurred within 5-30 min after medication. In ADR reports， there were a variety of drugs combined with Shuxuening injection. Shuxuening injection combined with Alprostadil injection was most common （61 cases， accounting for 23.46％ of drug combination）. Among 1 648 ADR cases， there were 622 cured cases and 1 039 cases improved， 4 cases were not improved， 3 cases had sequelae and 1 case died. CONCLUSIONS： Clinical application of Shuxuening injection should strictly follow the indications of drug package inserts； differentiation of symptoms and signs is based on specific dosage， solvent， route of administration， etc. It is necessary to strengthen the prescription check， and strengthen the observation after medication especially for the elderly and other special groups so as to reduce and avoid ADR.