OBJECTIVE： To investigate the situation of pediatric off-label drug use， explore reasonable and practical countermeasures， and promote rational drug use in the clinic. METHODS： The problems of pediatric off-label drug use were analyzed in respects of domestic and foreign situation， reasons， advantages and disadvantage， etc. Countermeasures were put forward to standardize pediatric off-label drug use. RESULTS： The types of pediatric off-label drug use mainly are pediatric medication information， dosage and indications not mentioned in package inserts. Pediatric off-label drug use mainly occur in childhood， adolescence and infancy stage， and main drug types involved are respiratory system drug， anti-infectious agent and Chinese patent medicine. CONCLUSIONS： The pediatric off-label drug use can be standardized with countermeasures， such as establish and perfect relevant laws and regulations， formulate off-label drug use guidance and management standard， strengthen sense of social responsibility of pharmaceutical enterprises， improve practice level of medical staff， institutionalize and standardize package inserts revise， to promote rational and legal use of drugs in the clinic.