Tavaborole

Tavaborole is a prescription medication used for the treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum or Trichophyton mentagrophytes. 

• Tavaborole is available under the following different brand names: Kerydin.

Common side effects of Tavaborole include:

• Application site irritation (redness, itching, swelling, or skin peeling), and
• Ingrown toenails

Serious side effects of Tavaborole include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Rash,
• Itching, and
• Severe dizziness

Rare side effects of Tavaborole include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Solution

• 43.5 mg/mL (0.5%)

Onychomycosis of the Toenail

Adult dosage

• Clean and dry nails before use; apply to completely cover the nail surface and under the tip of each nail being treated; allow the solution to dry following application.
• Apply to affected toenails once a day for 48 weeks.

Pediatric dosage

• Children below 6 years
  • Safety and efficacy not established.
• Children 6 years and above
  • Clean and dry nails before use; apply to completely cover nail surface and under the tip of each nail being treated; allow the solution to dry following application.
  • Apply affected toenails once a day for 48 weeks.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tavaborole has no noted severe interactions with any other drugs.
• Tavaborole has no noted serious interactions with any other drugs.
• Tavaborole has no noted moderate interactions with any other drugs.
• Tavaborole has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None reported by the manufacturer.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tavaborole?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tavaborole?”

Cautions

• Not for oral, ophthalmic, or intravaginal use
• Avoid contact with eyes, mouth, vagina, or skin immediately surrounding treated nail, wipe away excess solution from surrounding skin.
• Product is flammable; avoid use near heat or open flame.

Pregnancy and Lactation

• There are no available data on use in pregnant women to inform a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes; in oral animal reproductive studies, administration of tavaborole during the period of organogenesis resulted in embryofoetal toxicity and malformations at 570 times the Maximum Recommended Human Dose (MRHD) based on Area Under the Curve (AUC) comparisons in rats and embryofetal toxicity at 155 times the MRHD based on AUC comparisons in rabbits; embryofetal toxicity was noted following dermal administration in rabbits up to 36 times the MRHD based on AUC comparisons
• Lactation
  • There is no information available on the presence of human milk, its effects on breastfed infants, or on milk production in women who are breastfeeding; the drug is systemically absorbed; lack of clinical data during lactation precludes a clear determination of the risk of therapy to a breastfed infant; therefore, the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed child from treatment or underlying maternal condition