OBJECTIVE:To evaluate the characteristics and regularity of adverse drug reactions (ADR) in children's hospital. METHODS:The clinical drug use and ADR of 3 653 children during 2006～2008 in our hospital were analyzed statistically by designing a child medication registration form. RESULTS:The incidence of 498 ADR cases was about 13.63%; ADR were mostly occurred in 1～3 year-old children(36.14%); 71.29% were caused by intravenously; 66.87% were induced by antibiotics; ADR were more common in spring and winter. CONCLUSION:The drugs have a dual nature. Moreover,children belong to a special group. The measures such as strictly mastering clinical indications,reducing irrational drug use,sufficient therapy and avoiding or reducing the occurrence of ADR can guarantee children grow healthily.