OBJECTIVES: To assess the overall risk of bevacizumab related adverse events in patients with metastatic colorectal cancer (mCRC). METHODS: A systematic review of the literature was conducted. The selection criteria of the studies for this review were: health technology agencies reports, meta-analysis, systematic reviews, randomized controlled trials (RCTs) and observational studies in patients treated with bevacizumab for mCRC. MEDLINE, EMBASE, the Cochrane Library, and CRD databases were searched until June 8, 2011. The selection of the studies, quality assessment, data extraction and data analysis were done independently by two authors. Disagreements were resolved by a third reviewer until consensus was obtained. RESULTS: To evaluate the safety profile of bevacizumab, two systematic reviews with meta-analysis and two observational studies were included (the BEAT and the BRiTE studies). A total of 3271 patients were included in one meta-analysis, which evaluated the risk of fatal adverse events (FAE) and 3,385 patients were included in the other meta-analysis, which evaluated any grade of toxicity. An increased risk of FAE was not observed between patients with mCRC receiving bevacizumab in combination with chemotherapy and patients receiving chemotherapy alone [Relative Risk (RR):1.21 Confidence Interval (CI) 95%: 0.65-2.24]. Patients treated with bevacizumab had an increased risk of developing grade 3-4 hypertension (RR: 4.27; CI95%: 2.80–6.51), any grade gastrointestinal perforation (RR: 5.04; CI95%: 1.72–14.79), grade 3-4 arterial thromboembolic events (RR: 1.23; CI95%: 0.93–1.62), and discontinuation because of grade 3-4 adverse events (RR: 1.21; CI95%: 1.03–1.43). The results from the observational studies were consistent with the data reported in the meta-analysis. CONCLUSIONS: Although the risk of FAE was not increased with bevacizumab in patients with mCRC, grade 3-4 hypertension, any grade gastrointestinal perforation, grade 3-4 arterial thromboembolic events, and discontinuation due to grade 3-4 adverse events were higher in the bevacizumab group.