Abstract: Objective To analyze the information of children's safe medication in Adverse Drug Reactions Information Bulletin published by China Food and Drug Administration (CFDA) website, and promote the rational use of medicines in children. Methods Check the information of adverse drug reactions released by CFDA website from November 19, 2001, to January 5, 2017, and extract information about the children's safe medication. Results A total of 40 cases of adverse drug reactions/events in children were reported. Among them, there were 25 cases of adverse drug reactions/events, accounting for 62.50% (25/40), and 15 cases of serious adverse drug reactions/events, accounting for 37.50% (15/40). The number of anti-infective drugs was up to 19 cases, accounting for 47.50 % (19/40). In the 40 cases of adverse drug reactions/events, the unreasonable drug use was up to 75.00%. Conclusion It is necessary to call for the whole community to pay close attention to children's safe medication, to strengthen the children's rational drug use training and management for medical staff at all levels, and to solve the problem of children's medication from the policy and legal level.

Key words: children, safe medication, adverse drug reactions, adverse drug events