The Use of Terbinafine in the Treatment of Onychomycosis in Adults and Special Populations: A Review of the Evidence

Terbinafine is an allylamine with fungicidal activity, first approved for the treatment of onychomycosis in the United Kingdom in the early 1990s, and in the US in 1996. Terbinafine is the most frequently prescribed oral antifungal agent in the US and Canada for onychomycosis. Its efficacy and safety in dermatophyte toenail onychomycosis in adults has been established in many studies. In fact, 18 randomized controlled trials have shown terbinafine to be highly effective, with a meta-average for mycological cure of 76% ± 3% (mean ± standard error). In large surveillance studies, terbinafine exhibited excellent safety profiles consistent with results obtained in pivotal studies. Additionally, terbinafine has been reported to be superior to both itraconazole and fluconazole in comparative studies in the treatment of dermatophyte toenail onychomycosis. Recent studies have reported terbinafine to be more cost effective than griseofulvin, fluconazole, or itraconazole. Terbinafine has also been used to treat onychomycosis effectively and safely in special patient populations, such as children, the elderly, immunocompromised patients, diabetics, and those with Down syndrome. Terbinafine should therefore be considered for the management of onychomycosis in adults based on its effectiveness, broad spectrum, fungicidal nature, established safety profile, and very low occurrence of drug interactions. Furthermore, the data support the use of terbinafine to treat dermatophyte onychomycosis in children and the elderly.