Abstract: Objective of the past 4 years Xixinnao injection adverse reaction/event(ADR/ADE) reports were reviewed, provide a reference for clinical medication. Methods Jinan ADR Monitoring Center received 161 cases 2006~2009 Xixinnao injection of new, serious(the new strict) of ADR/ADE reports were collected and analyzed. Results Xixinnao injection of 161 patients with new stringent ADR/ADE cases occurred within 20min of time in 129 drug cases, accounting for 80.12%; children as high risk group, accounting for 49.69% in all cases. Xixinnao injection production process of accessories, the stability of the drug itself, and the combination of clinical medicine such as the joint leading to ADR/ADE of the main reasons. Conclusion Xixinnao injection in clinical ADR/ADE should attract great attention of clinical medicine; proposed system for pharmacy instructions. Hope that the security departments of the drugs should be further studied.

Key words: Xixinnao injection, adverse reaction/event, children, Solubilizer(Tween 80)