Abstract: Objective： In order to provide references for accelerating the clinical safe medication， we analyzed the characteristics and general regulation of adverse drug reaction/event (ADR/ADE). Methods： 3062 cases of adverse drug reactions reported were studied retrospectively in Ma′anshan area of 2013. The statistical analysis was performed separately by report type， sex of the patients， types of ADR/ADE， drug varieties， dosage form， route of administration， and ADR/ADE involving organ/system. Results： There were 24 new and serious ADR/ADE cases (0.78%)of 3062 ADR/ADE cases. 40 to 49， 50 to 59 and 60 to 69 age groups lay in the top three of ADR/ADE constituent ratios. The ratio of male to female was almost equal; most ADR/ADE caused by anti-infectives accounts for 46.57%. The most dosage form was injection (50.88%) and tablets (29.26%)， and intravenous drip occupied the main route of administration of ADR/ADE and the number is 1，726 cases (56.37%). The skin and its appendages damage was the major clinical manifestations， accounting for 34.13%. Conclusion： Adverse drug reactions monitoring should be further strengthened especially on the group with high incidence to reduce the occurrence of ADR/ADE as far as possible．