Abstract: Objective To analyze the safety risks associated with Gengnian’an preparations and provide a reference for rational clinical use. Methods Data on adverse drug reactions (ADR) caused by Gengnian’an preparations was collected from the National Adverse Drug Reaction Monitoring System database (between January 1, 2004 and April 30, 2025) and from such databases as China National Knowledge Infrastructure (CNKI) and Wanfang Medical Network (from inception to May 1, 2026). Results Between January 1, 2004 and April 30, 2025, a total of 859 ADR cases involving Gengnian’an preparations were reported in the National ADR Monitoring System database, including 13 serious ones (1.51%). These ADRs involved the gastrointestinal system (49.68%), nervous system (16.99%), skin and subcutaneous tissue (12.58%), and general disorders and conditions at administration sites (6.61%). Clinical manifestations included nausea, dizziness, diarrhea, rash, vomiting, abdominal pain, headache, pruritus, abdominal discomfort and dry mouth. Other reported adverse reactions included menstrual disorders, liver injury, hepatocellular injury, abnormal liver function and jaundice. In December 2025, the National Medical Products Administration (NMPA) unified the revision of package inserts for Gengnian’an preparations. Conclusion Clinicians should remain alert to the risks of liver injury, bleeding, and other hazards associated with Gengnian’an preparations, and prescribe this drug based on syndrome differentiation. Marketing authorization holders should fulfill their responsibility and strengthen proactive adverse reaction monitoring and early warning based on real-world data.

Key words: Gengnian’an Preparations, Liver Injury, Abnormal Uterine Bleeding, Safety, Package Insert, Adverse Drug Reaction (ADR)