OBJECTIVES: We conducted a meta-analysis to compare the febuxostat and allopurinol in hyperuricemic patients diagnosed with or without Gout. MATERIAL AND METHODS: We searched the Pubmed, Cochrane and Embase electronic databases to identify the studies concerning febuxostat versus allopurinol in treatment of hyperuricemic subjects and/or gout updated to May, 2020. After rigorous evaluation on quality, the data was extracted from included publications. RESULTS: A total of 10 articles involving 6989 subjects were included, with 4841 receiving febuxostat and 2148 using allopurinol. The pooled analysis showed that the febuxostat group (40, 80, or 120 mg QD) was greater in reducing serum urate levels than the allopurinol group (200 or 300 mg) (RR=1.56, 95% CI=1.37-1.78, P<0.00001). In addition, daily dosing of febuxostat 80 mg had greater efficacy to that of febuxostat 40 mg (RR=1.47, 95% CI=1.34-1.60, P<0.00001), and febuxostat 120 mg/day was associated with lower serum urate levels versus febuxostat 80 mg/day (RR=1.08, 95% CI=1.02-1.13, P=0.004). In terms of the adverse events, the pooling overall adverse events data did achieve advantage in the febuxostat group (RR=0.96, 95% CI=0.92-1.00, P=0.04). While, liver function test abnormalitie , diarrhea, skin rashes, musculoskeletal and connective tissue disorders, gastrointestinal disorders, headaches, the statistical significance between the two groups fail to be achieved (P≥0.05). CONCLUSION: Febuxostat was superior in reducing the serum urate levels of hyperuricemic patients, while with an acceptable tolerability profile than allopurinol. Moreover, our result suggested that dose titration to febuxostat 120 mg daily was superior to other daily dosing with regard to urate-lowering efficacy.