AIM To analyze the 251 cases of new and severe adverse drug reactions(ADR),and to ensure safe medication for patients.METHOD A total of 251 cases of new and severe ADR reported to the hospital's national adverse drug reaction monitoring system from January 2022 to December 2023 were collected by retrospective analysis.The analysis included the patient gender,age,outcomes,types of drugs involved,routes of administration,and the systems or organs affected by the ADRs.RESULTS Among 251 cases of ADR,137 cases were severe ADR,88 cases were new general ADR and 26 cases were new and severe ADR.Among the 251 cases of ADR,55.78%were female and 44.22%were male with 146 cases(accounting for 58.17%)of patients aged 60 years or above.The administration method for the 251 cases of ADR was predominantly intravenous infusion,followed by oral administration.The new ADR predominantly affected the nervous system(25.64%),while severe ADR primarily involved the skin and appendages(28.57%).The main types of drugs implicated were anti-infective drugs(51 cases,20.32%),nervous system drugs(36 cases,14.34%),and antineoplastic drugs(32 cases,12.75%).Pentoxifylline injection was the most involved drug(18 cases,7.17%),followed by moxifloxacin hydrochloride and sodium chloride injection(6 cases,2.39%)and docetaxel injection(6 cases,2.39%).Among the 251 cases of new and severe ADR,175 cases(69.72%)were improved and 75 cases(29.88%)were cured after active clinical treatment.CONCLUSION New and severe ADR are more likely to occur in female,elderly patients,and those using anti-infective drugs and nervous system drugs.Clinical monitoring should be strengthened for those patients to ensure safe medication.