Efinaconazole Topical
Efinaconazole is a topical 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 1 clinical label set 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 →
📖 Efinaconazole Topical: Patient Information Guide
A plain-language walkthrough of Efinaconazole 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▾
Efinaconazole topical solution is an antifungal used to treat fungal nail infections of the toenails.
- Jublia (efinaconazole topical solution, 10%) is indicated for the topical treatment of onychomycosis (fungal nail infection) of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes
⚙️How it works▾
Efinaconazole is an azole antifungal. Azoles work by blocking an enzyme the fungus needs to make ergosterol — a key building block of its cell membrane. Without ergosterol, the fungal cell membrane breaks down, and the fungus can no longer grow or survive. Applied directly to the nail, the solution penetrates the nail to reach the infection.
💊How it's taken▾
Jublia topical solution is applied to affected toenails once daily using the built-in flow-through brush applicator. Treatment lasts 48 weeks — this long course is needed because toenails grow slowly and it takes time to clear the infection. Make sure to cover the entire nail: the top surface, the folds of skin around the nail, the nail bed, and the underside of the nail plate.
- Apply once daily to affected toenails only
- Use the integrated brush applicator that comes with the bottle
- For topical use only — not for oral, eye, or vaginal use
- If you miss a dose, apply it as soon as you remember and continue with your regular schedule
🤒Side effects — in detail▾
Most side effects from Jublia happen right where you apply it and are generally mild. Common ones include:
- Ingrown toenail
- Skin irritation (dermatitis) at the application site
- Small blisters (vesicles) at the application site
- Pain at the application site
- Redness or peeling at the application site (reported after the product was on the market)
- Nail discoloration
- Onychomadesis (nail separation or nail loss)
Contact your doctor if you notice severe irritation, nail separation, or significant nail discoloration that worries you.
⚠️Warnings & precautions▾
- For toenail use only: Jublia must not be swallowed, used in the eyes, or applied vaginally. If accidental exposure occurs, rinse well and seek medical advice.
- Pregnancy: There are no human data on Jublia use during pregnancy. Animal studies at very high doses showed some fetal harm only when the mother was also harmed. Talk to your doctor if you are pregnant or planning to become pregnant.
- Breastfeeding: It is unknown whether efinaconazole passes into breast milk. Discuss the benefits and risks with your doctor before using Jublia while nursing.
- Children under 6: Safety and effectiveness have not been established in children younger than 6 years old.
🔀What it interacts with▾
Based on lab studies, Jublia topical solution is not expected to cause significant interactions with other medications. At the levels found in the bloodstream after normal toenail application, efinaconazole does not appear to block or speed up the liver enzymes (CYP450) that process many other drugs.
- Efinaconazole does not inhibit or induce CYP450 enzymes at therapeutic concentrations — meaning it is unlikely to affect the blood levels of other medications you take
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▾
- Pregnancy: No human safety data exist. Tell your doctor if you are or could become pregnant before using Jublia.
- Breastfeeding: It is not known if efinaconazole enters breast milk. Weigh the benefits of breastfeeding against any potential risk with your doctor.
- Children under 6: Jublia is not established as safe or effective in children younger than 6 years old.
- Children 6 and older: Jublia's safety and effectiveness are supported for patients aged 6 and older based on adult trial data and a pediatric safety study.
- Older adults (65+): No major differences in safety or effectiveness were found compared to younger patients, though some older individuals may be more sensitive.
🔬Pharmacokinetics — how your body processes it▾
When Jublia is applied once daily to all 10 toenails for 28 days, only very small amounts of efinaconazole are absorbed into the bloodstream — peak blood levels are extremely low (under 1 ng/mL). The drug's half-life (the time it takes for blood levels to drop by half) is about 30 hours after repeated daily application. Because so little enters the body through the nails, systemic effects are unlikely during normal use.
📦How to store it▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) . keep away from heat or flame. Protect from freezing.
📄 Written from Efinaconazole 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 Efinaconazole Topical
3 supplements and herbal products have documented interactions with Efinaconazole 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 Efinaconazole Topical — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Jublia treating on my toenail? ▾
Do I really have to use it for 48 weeks? That seems like a long time. ▾
How do I apply it correctly? ▾
What side effects should I watch out for? ▾
Can I use Jublia if I'm pregnant or breastfeeding? ▾
Will Jublia interact with any of my other medications? ▾
Is Efinaconazole Topical available over the counter? ▾
When was Efinaconazole Topical first available? ▾
💬 Answers drafted from Efinaconazole 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 Efinaconazole Topical comes
Efinaconazole 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
- Jublia is used to treat onychomycosis (fungal nail infection) of the toenails caused by Trichophyton rubrum or Trichophyton mentagrophytes
- Jublia is applied to affected toenails once daily for 48 weeks using the integrated flow-through brush applicator
- Jublia should cover the full toenail surface, the skin folds around the nail, the nail bed, and the underside of the nail plate
- Jublia is for topical use on toenails only — do not take it by mouth, use it in the eyes, or use it vaginally
📊 Efinaconazole Topical across the U.S. market
How Efinaconazole 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.
📈 How widely Efinaconazole Topical is used
A general measure of how commonly Efinaconazole 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 Efinaconazole 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 Efinaconazole Topical prescribed? Of the 1,596 medications we measure, Efinaconazole Topical ranks #798 by Medicaid prescriptions — more than 50% of them.
Utilization by Efinaconazole 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.
efinaconazole 100 MG/ML Topical Solution
Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1539757
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 Efinaconazole 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 2 of 5 listed Efinaconazole Topical NDCs with Medicaid activity.
🔍 Compare Efinaconazole Topical products
A representative set of FDA-listed product records for Efinaconazole 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 | ||||
| 100 mg/mL | Topical | Bausch Health US LLC × 2 listings | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Efinaconazole 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 Efinaconazole 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 Efinaconazole 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 Efinaconazole 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 1539753 1 dose form · 1 strength
-
Dose form (SCDF) Topical Solution RxCUI 1539756In current FDA listingsClinical drug / strength (SCD) 100 MG/MLRxCUI 1539757
Look up RxCUI 1539753 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 Efinaconazole 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
Efinaconazole Topical belongs to the Azole 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 1 FDA-filed SPL label set 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. Bausch Health US LLC 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.