Abstract: Objective To analyze the incidence of new adverse drug reactions (ADR) induced by Chinese patent medicines among 1 939 elderly patients in Weifang, and to identify contributors to ADR in the elderly so as to provide references for monitoring of the safety of Chinese patent medicines. Methods A total of 13 553 ADR reports submitted to the spontaneous reporting system of the Weifang Adverse Drug Reaction Monitoring Center between January 1 2019 and January 1, 2025 were collected. Patients ages 60 and older were selected as the subjects. Among them, 1 939 cases (14.31%) of new ADR were identified and analyzed in terms of gender, age, drug category, routes of administration, affected systems-organs, and major clinical manifestations. Results The incidence of new ADR was higher in elderly females than in elderly males, with the majority of cases in the group ages 60 to 75. However, severe ADR were more prevalent in males. Among the reported cases, 1 212 (62.51%) ADR occurred on the first day of medication. The most common route of administration was oral (89.79%), followed by intravenous infusion (8.30%). The top five categories of Chinese patent medicines by function were blood-regulating agents, tonifying agents, collateral-dredging and pain-relieving agents, dampness-eliminating agents, and joint-relieving and collateral-dredging agents. The most commonly affected systems were the digestive system (57.26%) and the central and peripheral nervous systems (11.92%). Conclusion Chinese patent medicines should be used more rationally in the elderly in clinical practice. It is recommended that medical institutions enhance targeted ADR monitoring based on different age groups and varieties of Chinese patent medicines to ensure safe and rational clinical use.

Key words: Elderly, Chinese Patent Medicines, Blood-Regulating Agents, Medicines Promoting Blood Circulation and Removing Stasis, Digestive System, Central and Peripheral Nervous Systems, Adverse Drug Reactions