Objective：Drug safety is not“ zero risk”. Awareness of drug safety is generally limited due to the shortage of sample size，shorter observation time and single subjects in premarket clinical trials，and many potential risks have not been discovered. To analyze drug safety risk management of Pediatric Compound Amino Acid Injection，further improve and optimize the safety risk management measures. Methods：This article summarized and analyzed the monitoring data of adverse reactions of Pediatric Compound Amino Acid Injection from 2016 to 2019，including analysis of medication population，medication reasons，usage and dosage， route of administration and medication area. Identified and evaluated the potential safety risks of the products，implemented the safety control measures of the products，minimized the risks， and effectively guaranteed the medication safety of patients. Results：The adverse reactions of the product mainly focus on unexpected types，and their SOC are mainly focus on skin and subcutaneous tissue disorders and Gastrointestinal disorders. In addition，the fast drip was an important reason for the adverse reactions of Pediatric Compound Amino Acid Injection，and there is also obvious region difference. The major causes include the lack of clinical medication standards，clinical medication habits，inadequate hospital monitoring and management，and cognitive deviation of medical staff. Conclusion：The adverse reactions of skin and subcutaneous tissue disorders and Gastrointestinal disorders are added to product patient inserting，which can guide clinical medication and greatly reduce the risk of new adverse reactions. The analysis results showed that after the training of salesmen and the face to face communication of clinical medical and nursing personnel，the adverse reactions caused by fast drip decreased from 12.67% to 6.47%. The drug safety risk management methods and measures of this product are effective.