Tavaborole Topical
Tavaborole topical solution is an antifungal used to treat onychomycosis (fungal nail infection) of the toenails.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 8 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Tavaborole Topical: Patient Information Guide
A plain-language walkthrough of Tavaborole Topical — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Tavaborole topical solution is approved to treat fungal toenail infections caused by specific fungi. Here is what the evidence supports:
- Onychomycosis (fungal nail infection) of the toenails caused by Trichophyton rubrum or Trichophyton mentagrophytes
- Approved for use in adults and children 6 years of age and older
⚙️How it works▾
Tavaborole is classified as an oxaborole antifungal. It works by blocking a specific enzyme — called an aminoacyl-tRNA synthetase — that fungi need to make proteins. Without this enzyme working properly, the fungus cannot grow or survive. This is a distinct mechanism from many other antifungals, targeting the protein-building process directly.
In laboratory and clinical studies, Trichophyton rubrum and Trichophyton mentagrophytes strains did not develop resistance to tavaborole after repeated exposure — a reassuring finding for long treatment courses.
💊How it's taken▾
Tavaborole topical solution is applied once daily to the toenails. It should cover the entire nail surface and be worked under the tip of each nail being treated. Treatment lasts 48 weeks — nearly a year — because nails grow slowly and fungi take time to clear.
- Apply to all affected toenails once a day
- Make sure to cover the full nail surface and under the nail tip
- For external use on toenails only — not to be swallowed or used in the eyes or vaginally
- Follow your prescriber's guidance on timing; no specific food restrictions apply to this topical medication
🤒Side effects — in detail▾
Most side effects from tavaborole topical solution are mild and happen right where you apply it. Common ones include:
- Skin peeling or flaking at the application site
- Redness at the application site
- Skin irritation or contact dermatitis at the application site
- Ingrown toenail
More rarely, hypersensitivity (allergic) reactions and contact allergy have been reported after the medication reached the market. If you notice swelling, a rash, or severe irritation, stop using it and contact your doctor right away.
⚠️Warnings & precautions▾
- Allergic reactions: Though uncommon, hypersensitivity and contact allergy have been reported. Stop use and seek medical advice if you develop signs of an allergic reaction.
- Pregnancy: No human safety data exist. Animal studies at doses far higher than the human topical dose showed potential fetal harm. Discuss risks and benefits with your doctor if you are pregnant or trying to conceive.
- Breastfeeding: This medication is absorbed through the skin in small amounts, and it is unknown whether it passes into breast milk. Talk to your doctor about the best approach if you are breastfeeding.
- External use only: Do not swallow, use in the eyes, or use vaginally.
🔀What it interacts with▾
Based on laboratory studies, tavaborole at therapeutic concentrations does not appear to significantly interact with medications processed by the liver's cytochrome P450 enzyme system. No specific drug interactions have been identified in the label.
- Tavaborole does not inhibit or induce CYP450 liver enzymes in lab studies — meaning it is unlikely to raise or lower levels of other medications processed this way
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnant? Animal studies showed fetal harm at very high doses — discuss risks with your doctor before using.
- Breastfeeding? It is unknown if this passes into breast milk; weigh the benefit of treatment against any potential risk to your baby with your doctor.
- Children under 6: Safety and effectiveness have not been established in children younger than 6 years old.
- Older adults (65+): Clinical trial data showed no significant differences in safety or effectiveness compared to younger adults, but some individuals may be more sensitive — report any unusual reactions to your doctor.
📡Pharmacodynamics — effects in the body▾
At the doses used therapeutically, tavaborole topical solution is not expected to have any meaningful effect on the heart's electrical rhythm — specifically, it is not expected to prolong the QTc interval (a measure of heart rhythm on an electrocardiogram) to a clinically significant degree.
🔬Pharmacokinetics — how your body processes it▾
Even though tavaborole is applied to the toenails, a small amount is absorbed into the bloodstream through the skin and nail. The body extensively metabolizes (breaks down) tavaborole, and its breakdown products are eliminated mainly in the urine. In adults applying the solution daily to all ten toenails, stable blood levels were reached after about 14 days of use. In adolescents aged 12 to 16, blood levels were similar to those seen in adults after daily use.
📦How to store it▾
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Keep away from heat and flame. Keep out of reach of children.
📄 Written from Tavaborole Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Tavaborole Topical
3 supplements and herbal products have documented interactions with Tavaborole Topical in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Moderate · 2
- Minor · 1
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Tavaborole Topical — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is tavaborole used for? ▾
How long do I really need to use this for? That seems like a long time. ▾
What side effects should I expect, and when should I call my doctor? ▾
Can I use this if I'm pregnant or breastfeeding? ▾
Will this medication interact with other drugs I'm taking? ▾
How do I apply it correctly to get the best results? ▾
Is Tavaborole Topical available over the counter? ▾
When was Tavaborole Topical first available? ▾
Who makes Tavaborole Topical? ▾
💬 Answers drafted from Tavaborole Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Tavaborole Topical comes
Tavaborole Topical is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Topical solution
How this form is used
- Treats onychomycosis (fungal infection) of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes in patients 6 years and older
- Apply once daily to the entire surface of each affected toenail and under the tip of the nail
- Continue treatment for 48 weeks as directed
- For external use on toenails only — do not swallow, use in the eyes, or use vaginally
- Follow your prescriber's instructions for the exact application technique
📊 Tavaborole Topical across the U.S. market
How Tavaborole Topical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Tavaborole Topical is used
A general measure of how commonly Tavaborole Topical is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Tavaborole Topical is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Tavaborole Topical prescribed? Of the 1,596 medications we measure, Tavaborole Topical ranks #912 by Medicaid prescriptions — more than 43% of them.
Utilization by Tavaborole Topical product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
tavaborole 43.5 MG/ML Topical Solution
Summed across the 5 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1543177
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tavaborole Topical, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 5 of 20 listed Tavaborole Topical NDCs with Medicaid activity.
🔍 Compare Tavaborole Topical products
A representative set of FDA-listed product records for Tavaborole Topical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Topical solution | ||||
| 43.5 mg/mL | Topical | Alembic Pharmaceuticals, Inc. | ANDA | View NDC → |
| 43.5 mg/mL | Topical | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 43.5 mg/mL | Topical | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 43.5 mg/mL | Topical | Aleor Dermaceuticals Limited | ANDA | Find on DailyMed ↗ |
| 43.5 mg/mL | Topical | Amneal Pharmaceuticals NY LLC × 3 listings | ANDA | View NDC → |
| 43.5 mg/mL | Topical | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 43.5 mg/mL | Topical | Chartwell RX, LLC | ANDA | View NDC → |
| 43.5 mg/mL | Topical | Cipla USA Inc. × 3 listings | ANDA | View NDC → |
| 43.5 mg/mL | Topical | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 43.5 mg/mL | Topical | Mayne Pharma Commercial LLC × 2 listings | ANDA | View NDC → |
| 43.5 mg/mL | Topical | Mayne Pharma Inc. | ANDA | View NDC → |
| 43.5 mg/mL | Topical | Padagis US LLC | ANDA | View NDC → |
| 43.5 mg/mL | Topical | PharmaDerm, A division of Fougera Pharmaceuticals Inc. | NDA | View NDC → |
| 43.5 mg/mL | Topical | Taro Pharmaceuticals U.S.A., Inc. | ANDA | View NDC → |
| 43.5 mg/mL | Topical | Viona Pharmaceuticals Inc × 2 listings | ANDA | View NDC → |
| 43.5 mg/mL | Topical | Zydus Lifesciences Limited × 2 listings | ANDA | View NDC → |
Showing 24 of 24 products — FDA National Drug Code Directory. See every product, package size and price: browse all 24 Tavaborole Topical NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Tavaborole Topical — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Tavaborole Topical in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Tavaborole Topical went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1543173 1 dose form · 1 strength
-
Dose form (SCDF) Topical Solution RxCUI 1543176In current FDA listingsClinical drug / strength (SCD) 43.5 MG/MLRxCUI 1543177
Look up RxCUI 1543173 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Tavaborole Topical is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Tavaborole Topical belongs to the Oxaborole Antifungal class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 8 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Cipla USA Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.