Objective To review the occurrence and relevant factors of adverse drug reactions (ADR) of Xueshuantong Injection. Methods Articles and documents in CNKI, VIP, and CBM were searched in June 2014 according to incorporation and exclusion standard. The dose, indication, medicating path and method, solvent, as well as the duration of treatment course and adverse reaction of Xueshuantong Injection were analyzed. The national information system for monitoring ADR was searched to collect adverse reaction cases of Xueshuantong Injection (2004.9-2014.9) reported in Lanzhou region. Cases were analyzed and under analogy with literature results. Results Totally 66 articles involving 4686 patients were included (except for patients of control group). Adverse reactions occurred in 767 patients, including skin damage (402 cases), systemic damage (221 cases), gastrointestinal system damage (75 cases). All of these were relieved after treatment. There were 11 adverse reaction cases of Xueshuantong Injection from Lanzhou region reported in the national information system for monitoring ADR. Conclusion There is a high incidence of adverse reactions in the clinical application of Xueshuantong Injection and ratio of serious adverse events report.