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Objective To analyze the risk factors of pediatric off-label drug use, and propose management strategies for policy making of the pediatric off-label drug use in China. Methods (i) We applied stratified random sampling to select recipes of children aged 0 to 18 years in pediatric clinics and wards of the West China Second University Hospital in 2010. (ii) All included prescriptions were categorized as off-label use or on-label use, according to the latest package insert licensed by the State Food and Drug Administration. (iii) Risk factors and the weights were calculated using logistic regression. (iv) The correlation between risk factors and the different kinds of off-label prescriptions was presented using adjusted odds ratio, and the impact of the risk factors was measured using standardized partial regression coefficient. (v) SPSS 16.0 was used for statistic analysis. (vi) From the perspective of the medical institutions, pharmaceutical enterprises, professional institutions, and the public, we combined the results of the Evidence-based research on the policy of the off-label drug use in 15 countries and the results of risk factor analysis, in order to propose management strategies for the policy making of pediatric off-label drug use in China. Results (i) Using the method of sampling, we received 2640 recipes from outpatients and 14,374 prescriptions from 749 inpatients. (ii) The neonates (0 to 27 days) had higher risk in off-label drug use than the other three children age groups. (iii) The dermatological medicines (D), nervous system medicines (N), traditional Chinese medicines, and respiratory drugs (R) were high-risk off-label medicines whose labels should be updated more frequently. (iv) The great factors of off-label drug use are those influence health status and relate to health services (ICD-10:Z00-Z99) (mainly in the clinic of child care and growth development, and in the ward of chemotherapy). (v) Off-label drug use in the ward was 4.4 times than that in clinic service (P < 0.001), which suggested that off-label drug use in the ward may be a key point of the management of medical institutions. (vi) The risk of off-label essential drug use was 1.67 times than that of non-essential drug use. (vii) The risk of off-label Rx drug use was 3.2% higher than that of OTC (Over-The-Counter) drug use, without a significant difference. Conclusions (i) A management guideline for off-label drug use is urgently needed, with which we can guide medical institutions to establish the management regulations of off-label drug use. (ii) Pediatric clinical research should be promoted actively, and pharmaceutical enterprises should be encouraged to completely provide pediatric drug information. (iv) Academic organizations should be invited to join in for best professional drug use. (v) Pediatric patients and their families should receive the education on rational drug use. [ABSTRACT FROM AUTHOR]