Abstract: Objective To investigate the perception ability and management ability of reproduction toxicity risk of mycophenolate mofetil or mycophenolic acid in China, and to provide support to treat and prevent reproduction toxicity risk reasonably. Methods The literatures in domestic bibliographic databases, the individual adverse drug reaction cases in Vigibase, China adverse drug reaction database, and the risk management measures in domestic and overseas were analyzed. Results The reproduction toxicity risk of mycophenolate mofetil or mycophenolic acid has been identified. But in our country, the monitoring and perception of the reproduction toxicity risk is insufficient. Conclusion The reproduction toxicity risk of mycophenolate mofetil or mycophenolic acid will be existing for a long time, while the monitoring ability in our country legs behind other countries. In order to improve the monitoring and risk management ability on the reproduction toxicity risk of mycophenolate mofetil or mycophenolic acid, several departments, such as manufacturers, health professionals and regulators need do more efforts and communication.

Key words: mycophenolate mofetil and mycophenolic acid, reproduction toxicity, risk management measures