OBJECTIVE：To investigate the characteristics and regularities of the adverse drug reaction/event （ADR/ADE） induced by Compound amino acid injection （l8AA）， and to provide reference for clinical rational use of drugs. METHODS： A retrospective study was conducted to statistically analyze the 5 703 effective ADR/ADE reports induced by Compound amino acid injection （l8AA） collected by national ADR monitoring system from Jan. 1， 2004 to Dec. 31， 2013. RESULTS：In the 5 703 ADR/ADE reports， there were 2 436 cases of male， 3 265 cases of female， 2 cases of unknown gender； the ADR/ADE reports were gradually increased with the growth of patients’ age， especially the patients over 60 years old held the highest proportion （35.42％）； the ADR/ADE most occurred in drug using within 30 minute （44.24％） followed by 30 min-1 h （32.05％）； and the ADR/ADE mainly involved the gastrointestinal system damage（32.76％）， followed by systemic damage （25.01％）； moreover， there were 284 cases who using the drug against the contraindications （4.98％）. Reporting odds ratio method showed 3 risk signals， including dizziness， allergic-like reactions and anaphylactic shock； Chi-square test method showed 4 risk signals， including dizziness， chest tightness， allergic-like reactions and anaphylactic shock. CONCLUSIONS： Clinic should strengthen prevention and signals monitoring of ADR/ADE induced by Compound amino acid injection （l8AA） to avoid irrational drug use， reduce and prevent the recurrence of ADR/ADE.