Abstract: ObjectiveThe clinical applications and adverse reactions of Herba Leonuri were determined and the correlation of its efficacy and toxic and side effect were discussed. The literature evidence and research ideas were provided for making safety standards, and studying its safety based on its efficacious substance basis. MethodsAncient books, literature in past dynasties and references in the last decades at home and abroad about the efficacy and adverse reactions of Herba Leonuri were collated, analyzed and summarized. ResultsHerba Leonuri, which has the efficacy of promoting blood flowing, regulating menstruation, diuresis and detumescence, is a commonly used traditional Chinese gynecological medicine. It is always used to diseases of gynecology and diseases caused by immune system and circulatory system. A number of adverse reactions caused by Herba Leonuri and its preparations were reported. The adverse reactions of Herba Leonuri came down to urinary system, reproductive system, etc. And the most common organs damaged by Herba Leonuri were liver and kidney during conventional or excessive dose. ConclusionOnly under the process of efficacy-expression and conferring to the toxicological experiment of Herba Leonuri, can basement be provided for consummating safety standards and putting forward early-warning scheme of adverse reaction that can be referred in clinic. In this way Herba Leonuri can be ensured to be used safely.

Key words: Herba Leonuri, clinical application, adverse reaction