Abstract: Objective To analyze the causes and characteristics of the adverse drug reaction/event (ADR/ADE) cases induced by Xingnaojing injection provide references for clinical rational drug use. Methods 30 ADR/ADE cases induced by Xingnaojing injection were analyzed retrospectively. Results The middle-aged and the old patients accounted for 56.67%. The use of Xingnaojing injection in 43.33% cases is beyond the indications of the drug instructions. The dosage of Xingnaojing injection in 13.33% cases is more than the dosage of the drug instructions. 70.00% of ADR/ADE occurred within 30 minutes after administration. The ADR/ADE can occur in the first time medication or continuous administration process. 33.33% of the patients had combined medication. The ADR/ADE involved six systems-organs. Systemic damage in which allergic reactions and anaphylactic shock is majority accounted for 60.00%. Conclusion Clinicians should pay attention to allergies of patients. The instruction should be adhered to. The combined medication should be cautious. The monitoring of adverse drug reactions should been strengthened. The drug manufacturing enterprise should strengthen the quality control and drug safety research, and improve the drug instructions of Xingnaojing injection.