Abstract: Objective By analyzing 861 ADR/ADE reports of children Qingkailing injection and the drug instructions, to provide reference for reasonably using children medicines and improving the enterprise's drug instruction. Methods Using retrospective research, we counted and analyzed Qingkailing ADR/ADE reports during 2004~2009 from Henan center for drug reevaluation and the drug instructions of nine domestic pharmaceutical enterprises. Results There are 364 cases of child under 3 years of age(42.28%),140 cases of drug combination(16.26%) in which 64 cases are of child under 3 years of age(45.71%), 242 cases of ultra-indications(28.11%). The drug instruction lacks information for children's safety and the dosage. Conclusion It should be concern about the rational use of drug for children, improve the drug instruction, and ensure the medication safety for children.

Key words: children, Qingkailing injection, instruction, medication safety