Abstract:Objective To analyze the characteristics and rules of serious adverse drug reactions (ADR) in Heyuan People′s Hospital, to provide references for clinical rational use of drugs. Methods A total of 178 patients with severe ADR who were reported to Guangdong ADR Monitoring System by Heyuan People′s Hospital from January 2018 to December 2019 were selected as the research subjects for retrospective analysis, including the general conditions of severe ADR patients, combined medication, the route of administration, the types of drugs, and the organs/system and other content. Results Of 178 serious ADR cases, the male to female ratio was 1∶0.91, with slightly more males than females.The number of patients aged >60 years was the largest, accounting for 42.70%. The number of severe ADR cases caused by one drug combination was the largest, accounting for 87.09%. Intravenous infusion was the most important way to cause severe ADR, accounting for 83.71%. The number of severe ADR cases caused by anti-infective drugs was the largest, accounting for 27.53%, followed by traditional Chinese medicine injections, accounting for 11.80%. Among the anti-infective drugs causing severe ADR, quinolones were the most, accounting for 28.57%. The most severe ADR involved organs/systems was skin and its appendages. New severe ADR and severe ADR accounted for 37.08% and 62.92%, respectively. After corresponding treatment, 147 cases of severe ADR were improved, 28 cases were cured, 2 cases were unknown, and 1 case was not improved. Conclusion It is necessary to strengthen the supervision of anti-infective drugs and traditional Chinese medicine injections, and standardize their use; and strengthen the monitoring of serious ADR, reduce or avoid the occurrence of serious ADR, and promote rational clinical use of drugs.