Abstract: By reviewing the relevant references and reports of the adverse drug reaction cases of Xiaozhiling in China, and analyzing the post marketing safety studies, the safety and risks in post-marketing period of Xiaozhiling is reevaluated in this article. The author puts forward risk management measures according to the characteristics of medicine. Suggestions are proposed for a safe and rational use of this medicine.

Key words: Xiaozhiling Injection, safety and risk, risk control, measure