Abstract: Objective To analyze the misuse risk of methotrexate and the enlightenment for pharmacovigilance. Methods This article summarized the basic situation of methotrexate, domestic and foreign literature about medication error of methotrexate and domestic and foreign regulatory measures. Results Both domestic and foreign literatures were reported about medication error of methotrexate. The foreign drug regulatory authorities issued a number of warnings. CFDA also issued Chinese Adverse Drug Reaction Information Bulletin (No.75). It is the first time to remind the problem of drug misuse in Bulletin. Conclusion Medical personnel should be aware of the misuse risk of methotrexate and give medication guidance for patients. Chinese Adverse Drug Reaction Information Bulletin could be an important management measure for pharmacovigilance.

Key words: Adverse Drug Reaction Information Bulletin, methotrexate, medication error, pharmacovigilance