Abstract: The retrospective study was used to review the adverse drug reaction of paracetamol, ibuprofen, alidine, analgin and aspirin-DL-lysine. Using method of comparative study, we introduced the medication guide, risk management strategy and risk intervention measures of FDA and EMA.Comparing pediatric labeling of paracetamol and ibuprofen between China and the U.S. This paper analyzed the reasons of problems existing in different aspects of pediatric antipyretic administration and gave proposals for its use.

Key words: antipyretics for children, adverse drug reaction, medication guide, risk management strategy, risk intervention measures