OBJECTIVE： To systematically review the safety of toremifene versus tamoxifen in the treatment of breast cancer， and provide evidence-based reference for clinic. METHODS： Retrieved from Medline， PubMed， EMBase， Cochrane Library， CJFD， CBM ， VIP and Wanfang Database， randomized controlled trails （RCT） and cohort study about toremifene versus tamoxifen in the treatment of breast cancer were collected. Meta-analysis was performed by using Rev Man 5.0 software after data extraction and quality evaluation. RESULTS： Totally 10 RCTs and 9 retrospective cohort studies were enrolled， involving 9 182 patients. Results of Meta-analysis showed， compared with tamoxifen group， there was no significant difference in the incidence of overall adverse reactions in toremifene group [RR＝0.88，95％CI（0.73，1.06），P＝0.18]； the subgroup analysis based on the dose of toremifene showed， compared with tamoxifen group， there were no significant differences in conventional dose group and high-dose group. Compared with tamoxifen group， there was no significant difference in the incidence of serious adverse reactions in toremifene group [OR＝0.60，95％CI（0.23，1.52），P＝0.28]. The incidences of thrombotic events [OR＝0.77，95％CI（0.60，0.98），P＝0.03]， adverse reactions in the digestive system [OR＝0.81，95％CI（0.70，0.94），P＝0.006]， irregular menstruation [OR＝0.61，95％CI（0.39，0.94），P＝0.03] and fever with or without chills [OR＝0.56，95％CI（0.34，0.92），P＝0.02] in toremifene conventional dose group were superior to tamoxifen group， with statistical significance. Compared with tamoxifen group， there were no significant difference in the incidence of various types of adverse reactions in toremifene high-dose group. CONCLUSIONS： Compared with tamoxifen， conventional dose of toremifene shows better safety in terms of adverse reactions in the digestive system， thrombotic events， irregular menstruation， fever with or without chills and other adverse reactions in the treatment of breast cancer.