OBJECTIVE:To provide baseline data for the formulation of the strategy for medical institutions in China. METH-ODS:3 600 discharged medical records were randomly collected from our hospital in 2013. According to drug package inserts,the judgment was carried out about whether off-label drug use existed in medical orders. The types of off-label drug use,off-label drug use of children in different age groups and of various drugs were all analyzed. RESULTS:A total of 3 268 hospitalized children were includ-ed,and 35 523 medical orders were analyzed,involving 468 types. Based on children,medical orders and drug types,the incidence of off-label drug use were 91.34%,35.72%and 48.72%,respectively. The types of off-label drug use mainly included pediatric medica-tion information(74.21%), exceeding route of administration(8.12%)and overage(8.45%). The top 3 age groups with respect to the incidence of off-label drug use were adolescents(42.42%),neonate(37.97%)and infant(35.48%). Top 4 drugs of off-label use in the list of medical orders were anti-infective drugs(23.65%),electrolytic,drugs for acid-base balance and nutrition(12.21%), drugs for respiratory system(36.84%)and cardiovascular drugs(63.21%). CONCLUSIONS:The off-label drug use of hospitalized children is common in our hospital. It is urgent to develop related laws and regulations or guidelines to regulate off-label drug use in or-der to ensure the safety of pediatric drug use.