ABSTRACT OBJECTIVE: To investigate the clinical characteristics and regularity of adverse drug reaction (ADR), and to provide reference for rational and safe drug use in the clinic. METHODS: ADR reports collected from our hospital by Guangdong ADR Monitoring Center during Jan. 2014 to June. 2015 were summarized and analyzed statistically. RESULTS: Of 433 ADR cases, there were 185 male cases (42.73%) and 248 female cases (57.27%), with ratio of 1 ∶ 1.34. The incidence of ADR was in high level (71.59%) in young and middle-aged patients (20-59 year-old); that of male was significantly lower than that of female (1 ∶ 1.37). ADR cases caused by intravenous drip (48.04%) and oral administration (41.57%) were most common. The most ADR cases were related with anti-infective drugs (167 cases, 38.57%), mainly were related with cephalosporins (64.07%). Organs/systems involved in ADR were main the damages of gastrointestinal system (262 cases, 36.19%) and the lesion of skin and appendants (237 cases, 32.73%). The serious ADR was mainly induced by anti-infective and anti-tumor drugs. CONCLUSIONS: Clinical medical personnel should strengthen the ADR monitoring of cephalosporin antibiotics and anti-tumor drug, and select route of administration carefully.