Objective To analyze the adverse drug reactions（ADR） or adverse events（AE） of Astragalus Injection and their related factors.Methods All the clinical studies and adverse reaction reports on the Astragalus Injection from January 1995 to May 2010 in the CNKI

VIP

and CBM database were retrieved and totally 2690 papers were enrolled for analysis.The information of the ADR/AE cases such as the original diseases

dosage

and compatibility of the Astragalus Injection;the age

gender and allergic history of patients;the happening time

type

treatment

and prognosis of the ADR/AE was extracted and analyzed.Results Of the 2604 clinical studies

there were 448 ADR/AE cases reported in 132 articles and 112 ADR/AE cases reported in 86 ADR reports.ADR/AE cases occurred mainly in the age of 40-69.The ADR/AE in ADR reports was mainly of systemic reactions（fever

allergic shock）

while the ADR/AE in clinical studies mainly occurred in digestive system（nausea）.The severity of 84.46% of the ADR/AE cases was of grade Ⅲ to Ⅳ

and no deaths case was found. The original diseases of the ADR/AE cases were mainly of myocarditis and heart failure.Of the ADR/AE cases

13（11.61%） had history of allergies.The menstruum of Astragalus Injection used in ADR/AE cases was mainly of 5% and 10% glucose solution and normal saline.A total of 107（19.1%） ADR/AE cases used Astragalus Injection in compatibility with other drugs.And 66.96% of the total ADR/AE cases occurred in the first time medication.Conclusion The occurrence of Astragalus Injection ADR/AE is a result of many factors involved.The clinical application of Astragalus Injection should be based on the instruciton file

and follow the guidance of TCM theory

remembering contraindications

asking the history of allergies before use

careful selecting menstruum

making effort to process monitoring and follow-up.