Efficacy of Fluconazole for the Treatment of Onychomycosis

Objective: To evaluate the efficacy of fluconazole for the treatment of onychomycosis. Data Sources: Searches of MEDLINE (1966–May 2009) and International Pharmaceutical Abstracts (1970–May 2009) were performed. Key search terms included fluconazole and onychomycosis. In addition, reference citations from identified publications were reviewed. Study Selection and Data Extraction: All articles in English identified from the data sources were evaluated. All studies evaluating oral fluconazole for the treatment of onychomycosis were included in the review. Data Synthesis: Seven studies evaluating fluconazole treatment for onychomycosis were identified. One study used daily dosing and the rest used once-weekly dosing. Treatment doses ranged from 100 mg to 450 mg weekly and 150 mg daily, and durations ranged from 12 weeks to 12 months. Most of the studies evaluated the efficacy of fluconazole in patients with toenail onychomycosis due to dermatophyte infection. Fluconazole was superior to placebo, with mycologic eradication rates ranging from 36% to 100% in placebo-controlled studies. In one of the comparative studies, the mycologic cure rate was lower with fluconazole (31.2%) compared with terbinafine (75%) and itraconazole (61.1%). Common adverse events reported with fluconazole use were headache, gastrointestinal pain, and diarrhea. Conclusions: Fluconazole is less effective than terbinafine and itraconazole in the treatment of onychomycosis. However, fluconazole may be preferred in patients unable to tolerate other oral antifungal agents due to the dosing regimen, adverse effect profile, and drug interactions.