FDA label
What is terbinafine used for?
The FDA-approved uses of terbinafine, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).”
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Terbinafine Hydrochloride, tablet
Indications and Usage, quoted from the label by Dr.Reddys Laboratories Limited (ANDA076390). Cross-references to other label sections are left out.
Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).
Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis.
Source: DailyMed label, set id e0b309a5-bebe-c6da-2847-bda21aa488b1, version 8, effective December 19, 2024. NDC 55111-250, one of 41 listings for this product.
Questions
What is terbinafine used for?
The FDA label says: “Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).”
What drug class is terbinafine?
FDA lists terbinafine in the Allylamine Antifungal established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.