"The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSS"...
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 Jublia (efinaconazole topical solution) Side Effects Center for a complete guide to possible side effects
In vitro studies have shown that JUBLIA, at therapeutic concentrations, neither inhibits nor induces cytochrome P450 (CYP450) enzymes.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/24/2015
Additional Jublia Information
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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.
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