Tavaborole First approved as Kerydin

What is tavaborole used for?

From the label: indications and usage

Tavaborole topical solution, 5% is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes. Tavaborole topical solution is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.

Conditions named in the indications of tavaborole's FDA labels, with every medicine labeled for each:

• Fungal infections

FDA pharmacologic class: Oxaborole Antifungal.

What does the patient leaflet for tavaborole say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What should I avoid while using tavaborole topical solution?

● Tavaborole topical solution is flammable. Avoid heat and flame while applying tavaborole topical solution to your toenail.

From the patient leaflet: How should I store tavaborole topical solution?

● Store tavaborole topical solution at room temperature, between 68°F to 77°F (20°C to 25°C). ● Tavaborole topical solution is flammable. Keep away from heat and flame. ● Keep the bottle tightly closed. ● Safely throw away tavaborole topical solution after 3 months of inserting the dropper. Keep tavaborole topical solution and all medicines out of the reach of children.

Is there a generic for tavaborole (Kerydin)?

The FDA approved the first generic tavaborole on October 13, 2020. 9 generic applications are approved; 4 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists tavaborole from 8 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

What do pharmacies pay for tavaborole (Kerydin)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $3.39 per mL (Tavaborole 5% topical solution), down 17% from $4.10 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Has tavaborole been recalled?

The FDA's Enforcement Report lists 2 recalls naming tavaborole since 2025: 0 Class I (the most serious), 2 Class II, 0 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.

What do FAERS reports show for tavaborole?

The FDA Adverse Event Reporting System holds 65 reports that list tavaborole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 3 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

• Drug Ineffective (a use or a product term, not a reaction)11
• Injection Site Pain4
• Off Label Use (a use or a product term, not a reaction)4
• Product Dose Omission In Error (a use or a product term, not a reaction)4
• Cough3
• Product Packaging Quantity Issue3
• Pruritus3
• Rash3

What else is labeled for the same conditions as tavaborole?

18 other medicines are given the same way (topical) and in the same FDA class as tavaborole or labeled mainly for the same use (fungal infections), the same class first. Fungal infections lists all 33 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

What next?

Tavaborole side effects

the label's list beside FAERS reports

Check an interaction

what two or more labels say about each other