"The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of dalbavancin 500 mg (Xydalba, Durata Therapeutics) for acute bacterial skin and skin structure infections (ABSSSI) in ad"...
Jublia Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Jublia (efinaconazole) topical solution is an azole antifungal used for the topical treatment of fungal infection of the nail bed (onychomycosis) of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes. Common side effects include ingrown toenail, inflammation, pain, or blisters at the application site.
Apply a once-daily dose of Jublia to affected toenails for 48 weeks, using the integrated flow-through brush applicator. Jublia may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Jublia should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Jublia (efinaconazole) topical solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Jublia FDA Prescribing Information: Side Effects
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 = 1227
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%)|
Read the entire FDA prescribing information for Jublia (Efinaconazole Topical Solution)
Additional Jublia Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.