Efinaconazole: uses, dosing, side effects & brands
Efinaconazole is a medicine sold in the U.S. under one brand, for onychomycosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Onychomycosis
- Available as
- Solution
- Sold as
- Jublia
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How efinaconazole is dosed
From the FDA label for Jublia (application NDA203567). Other efinaconazole products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Apply JUBLIA to affected toenails once daily for 48 weeks, using the integrated flow-through brush applicator. When applying JUBLIA, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered. JUBLIA is for topical use only and not for oral, ophthalmic, or intravaginal use. • Apply JUBLIA to affected toenails once daily for 48 weeks using the integrated flow-through brush applicator. (2) • When applying JUBLIA, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered. (2) • For topical use only. Not for oral, ophthalmic, or intravaginal use. (2)
Efinaconazole side effects
The most common adverse reactions (incidence >1%) were ingrown toenails, application site dermatitis, application site vesicles, and application site pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two clinical trials, 1227 subjects were treated with JUBLIA, 1161 for at least 24 weeks and 780 for 48 weeks. Adverse reactions reported within 48 weeks of treatment and in at least 1% of subjects treated with JUBLIA and those reported in subjects treated with the vehicle are presented in Table 1 . Table 1: Adverse Reactions Reported by at Least 1% of Subjects Treated for up to 48 Weeks Adverse Event, n (%) JUBLIA (N=1,227) Vehicle (N=413) Ingrown toenail 28 (2.3%) 3 (0.7%) Application site dermatitis 27 (2.2%) 1 (0.2%) Application site vesicles 20 (1.6%) 0 (0.0%) Application site pain 13 (1.1%) 1 (0.2%) 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of JUBLIA. Because these reactions are reported voluntarily from a population of…
Who shouldn’t take efinaconazole
None. None. (4)
Efinaconazole drug interactions
In vitro studies have shown that JUBLIA, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.
Every efinaconazole product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Jublia.
What people report to the FDA about efinaconazole
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 232 reports naming efinaconazole, and the FDA flagged 96% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- asthenia74 reports
- fatigue71 reports
- headache70 reports
- oedema peripheral70 reports
- anaemia67 reports
- drug hypersensitivity67 reports
- pyrexia67 reports
- blood creatinine increased65 reports
Read these as a signal, not a rate. A report does not mean efinaconazole caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is efinaconazole?
JUBLIA (efinaconazole) topical solution, 10% is a clear, colorless to pale yellow solution for topical use. Each gram of JUBLIA contains 100 mg of efinaconazole.
Can you take efinaconazole with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run efinaconazole against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does efinaconazole come in?
Across the brands we track, efinaconazole is currently marketed as solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic efinaconazole?
We do not currently list a generic-labelled efinaconazole product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Efinaconazole: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/efinaconazole
- MLA
- “Efinaconazole: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/efinaconazole.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for efinaconazole on DailyMed (NIH) ↗.