Abstract: Objective To analyze the safety risk of thiamazole tablets in China, so as to provide reference for clinical rational drug use. Methods The individual adverse drug reaction cases in Vigibase, China adverse drug reaction database,the literatures in foreign bibliographic databases, the domestic and original drug instruction and the domestic risk management measures were analyzed. Results The risk of agranulocytosis and liver damage of thiamazole should be concerned. It is important to monitor blood test and hepatic functions regularly. Conclusion The marketing authorization holder should carry out main responsibility and amend the safety information of drug instruction constantly to guarantee the public drug safety.

Key words: thiamazole/methimazole, agranulocytosis, liver damage, drug instruction