Abstract：Objective To evaluate the clinical efficacy and safety of itraconzole in comparison with other antifungal drugs (clotrimazole, fluconazole, ketoconazole and terbinafine) in the treatment of oral candidiasis and to provide an evidenced-base reference for clinical use. Methods The published studies for itraconazole in the treatment of oral candidiasis (up to June 2017) were retrieved from PubMed, EMbase, Medline, the Cochrane Library, and the Chinese literature databases (CBM, CNKI, VIP, and Wanfang Data). Relevant randomized controlled trials (RCTs) that compared itraconazole and other antifungal drugs were collected, followed by Meta-analysis using Rev Man 5.3 statistical software. Results A total of 8 RCTs were included, involving 892 patients. Meta-analysis showed that the effective rate of itraconazole group was equal to the fluconazole group [RR=0.82, 95%CI (0.62, 1.10), P=0.19] and clotrimazole group [RR=1.05, 95%CI (0.87, 1.26), P= 0.63]. However, the effective rate of the itraconazole group (65.9%) was significantly higher than that of the terbinafine group (33.3%). The microbiological cure rate of itraconazole group was equal to that of the fluconazole group [RR=0.87, 95%CI (0.75, 1.01), P=0.07]. The recurrence rate of itraconazole group was equal to that of the fluconazole group [RR= 0.85, 95%CI (0.51, 1.40), P=0.52]. Itraconazole did not increase the gastrointestinal adverse reaction [RR=1.10, 95%CI (0.59, 2.05), P= 0.77]. The incidence of other adverse reactions was not statistically significant. Conclusion In the treatment of oral candidiasis, itraconzole appears to perform no better than other antifungal drugs in both effectiveness and safety. However, the observations need to be regarded cautiously due to the very limited literature information that provided only small-scale and low-quality studies. Further validation by large-scale and high-quality RCTs is warranted.