Abstract: Objective To understand the serious adverse drug reactions/events(ADR/ADE) occurred in the characteristics and rules for clinical safe, effective and rational use of available information. Methods of Jinan City in 2009 collected 829 cases of serious ADR/ADE reports were retrospectively analyzed the data. Results 829 cases of serious ADR/ADE involving 273 drugs, which occupies the first anti-microbial drugs(accounting for 44.75%); involving 75 varieties of national essential drugs( accounting for 27 .47 % ) , in which serious ADR/ ADE cases , 270 cases ( accounting for 32.57%); route of administration by intravenous infusion of the largest proportion (accounting for 78.04% ); serious ADR/ADE main clinical manifestations of anaphylactic shock(accounting for 8.56%), respiratory, systemic and central nervous system damage. Conclusion strengthening serious ADR/ADE monitoring, to ensure clinical safety, effective, rational use of drug.

Key words: severe, adverse drug reaction/event(ADR/ADE), case analysis, rational use of drug