-Common (1% to 10%): Application site pruritus, application site erythema
-Uncommon (% to 1%): Application site bleeding, application site discomfort, application site dryness, application site inflammation, application site irritation, application site paresthesia, application site reaction
-Common (1% to 10%): Application site burning, application site reaction
-Frequency not reported: Application site reactions (dryness, erythema, irritation, paresthesia, pruritus, rash, warmth)
-Common (1% to 10%): Application site burning
-Frequency not reported: Treatment-related application site reactions (dermatitis, discharge, dryness, erythema, irritation, pain, pruritus, pustules)
-Postmarketing reports: Burning sensation, pain, skin irritation, erythema
-Uncommon (% to 1%): Application site erythema, application site irritation, application site pruritus, application site reaction
-Rare (% to %): Application site hypersensitivity, application site pustules
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
The safety and efficacy of once daily use of JUBLIA for the treatment of onychomycosis of the toenail were assessed in two 52-week prospective , multi-center, randomized, double-blind clinical trials in patients 18 years and older (18 to 70 years of age) with 20% to 50% clinical involvement of the target toenail, without dermatophytomas or lunula (matrix) involvement. The trials compared 48 weeks of treatment with JUBLIA to the vehicle solution. The Complete Cure rate was assessed at Week 52 (4 weeks after completion of therapy). Complete cure was defined as 0% involvement of the target toenail (no clinical evidence of onychomycosis of the target toenail) in addition to Mycologic Cure, defined as both negative fungal culture and negative KOH. Table 2 lists the efficacy results for trials 1 and 2.