Abstract: Objective To analyze the risk posed by Yinhuang oral preparation in order to provide a reference for proper clinical use. Methods Cases of adverse drug reactions (ADR) related to Yinhuang oral preparation retrieved from China's ADR monitoring database (collected between 2004 and 2023) and domestic databases (from inception to December 31, 2023) were sorted out and analyzed. Results Between January 1, 2004 and March 31, 2023, there were reports of a total of 8 700 cases of adverse drug reactions/adverse events (ADR/AE) related to Yinhuang oral preparation in the database, including 197 severe cases (2.26%). The ADR/AE reports from the national ADR monitoring system and literature showed that the ADR of Yinhuang oral preparation involved multiple systems and organs, and that the manifestations of adverse reactions varied, depending on dosage forms. The clinical manifestations included diarrhea, abdominal pain, abdominal discomfort, nausea, vomiting, rash, pruritus, and dizziness. There were also reports of individual cases of severe allergic reactions. The drug label of Yinhuang oral preparation was upgraded as required by the National Medical Products Administration (NMPA) on July 2, 2024. Conclusion Yinhuang oral preparation should be used with caution. Drug marketing authorization holders should strengthen pharmacovigilance and provide guidance to ensure safe medication.

Key words: Yinhuang, Oral Preparation, Adverse Drug Reaction, Safety, Instruction, Over-the-Counter Drugs