Abstract: Objective To analyze the safety risk of Tongbianling capsules, and to provide a reference for clinical rational drug use. Methods Adverse reaction reports in 2004-2023 involving the basic information, systems and organs, clinical manifestations, times of occurrence and outcomes of adverse drug reactions of Tongbianling capsules were retrieved from the National Adverse Drug Reaction Monitoring System Database and from CNKI、VIP before being analyzed. The way safety information in the package insert of this drug was revised was recommended. Results A total of 2 389 cases of adverse reactions/events of Tongbianling capsules were reported to the National Adverse Drug Reaction Monitoring System database, 33 of which (1.38%) were serious. Data and literature on adverse reaction monitoring suggested that the adverse reactions of Tongbianling capsules involved multiple systems and organs, including abdominal pain, diarrhea, nausea, abdominal distension, abdominal discomfort, vomiting, dry mouth, rash, itching and dizziness. There were several case reports of melanosis coli caused by long-term use of this drug. On October 10, 2024, the National Medical Products Administration（NMPA）of China issued a notice on the revision of the drug instructions for Tongbianling capsules. Conclusion Healthcare providers and patients alike should be aware of the safety profile of Tongbianling capsules and ensure their rational use. Medication should be discontinued once constipation is relieved or diarrhea occurs, and long-term administration has to be avoided. Marketing authorization holders (MAHs) should promote the safe and rational use of Tongbianling via related health education and pharmacovigilance.

Key words: Tongbianling Capsule, Melanosis Coli, Senna Leaf, Adverse Drug Reaction, Safety