OBJECTIVE： To investigate the characteristics and regularity of adverse drug reaction （ADR） in a third grade class A hospital， and to provide reference for rational drug use in clinic. METHODS： A total of 813 cases of ADR reported to National ADR Monitoring by the hospital during 2013-2015 were summarized and analyzed retrospectively in terms of age， gender， route of administration， drug type， organs or systems involved in ADR， clinical manifestation and outcome. RESULTS： Among 813 cases of ADR， there were 391 male （48.09％） and 422 female （51.91％）. Patients aged more than 60 were with high incidence of ADR， involving 347 cases （42.68％）. Among routes of administration， most ADR cases were caused by intravenous administration， involving 747 cases （91.88％）. Among all drug types， the number of ADR cases caused by anti-infective drugs was the most， involving 382 cases （46.99％）； cephalosporins took up the highest proportion， being 38.22％ （146 cases）. Organs or systems involved in ADR were mainly skin and its appendants， involving 434 cases （53.38％）. CONCLUSIONS： ADR monitoring should be strengthened for elderly patients receiving anti-infective drugs intravenously so as to reduce the occurrence of ADR and guarantee medication safety.