Abstract: To research the actuality of off-label drug use on pediatric inpatients in a certain hospital, and to analyze and comment on these cases to provide a reference for rational drug use and standard medication on children clinically.Methods:With the method of retrospective investigation, 600 hospitalized cases of pediatrics from February 1, 2016 to March 31, 2016 were selected at random. To read the package inserts of drug one by one. Then the prescriptions which are off-label use were screened out and analyzed their reasons.Results:A total of 600 hospitalized children were included, and 3769 medical orders were analyzed, involving 157 typed. By the number of prescriptions，medication records and drug types，the incidence of off-label drug use were 93.2%, 31.8% and 30.6%. The type of off-label drug use mainly included off-label suitable crowd（66.0%）, off-label indication (25.6%），exceeding route of administration（22.6%）, off-label dosage（11.1%）.The top-one drugs in the list of the incidence of off-label drug use were drugs for cardiovascular drugs (26.5%), the second were drugs for respiratory system (21.6%).Conclusion:The phenomenon of off-label drug use on pediatric inpatient is pervasive in the hospital. Relevant administrative departments should formulate the management system of off-label drug use which is supposed to be standardized reasonably, in order to guarantee safe medications for children, and to avoid drug risks.