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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 clinical practice.
In human dermal safety trials, TAZORAC® Cream, 0.05% and 0.1% did not induce allergic contact sensitization, phototoxicity, or photoallergy.
The most frequent adverse reactions reported with TAZORAC® Cream, 0.05% and 0.1% occurring in 10 to 23% of subjects, in descending order, included pruritus, erythema, and burning. Reactions occurring in greater than 1 to less than 10% of subjects, in descending order, included irritation, desquamation, stinging, contact dermatitis, dermatitis, eczema, worsening of psoriasis, skin pain, rash, hypertriglyceridemia, dry skin, skin inflammation, and peripheral edema.
TAZORAC® Cream, 0.1% was associated with a greater degree of local irritation than the 0.05% cream. The rates of irritation adverse reactions reported during psoriasis trials with TAZORAC® Cream, 0.1% were 0.1 0.4% higher than those reported for TAZORAC® Cream, 0.05%.
The most frequent adverse reactions reported during clinical trials with TAZORAC® Cream 0.1% in the treatment of acne, occurring in 10-30% of subjects, in descending order included desquamation, dry skin, erythema, and burning sensation. Reactions occurring in 1 to 5% of subjects included pruritus, irritation, face pain, and stinging.
Read the Tazorac Cream (tazarotene cream) Side Effects Center for a complete guide to possible side effects
No formal drug-drug interaction studies were conducted with TAZORAC® Cream.
In a trial of 27 healthy female subjects between the ages of 20 – 55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 μg ethinyl estradiol, concomitant use of tazarotene administered as 1.1 mg orally (mean ± SD Cmax and AUC0-24 of tazarotenic acid were 28.9 ± 9.4 ng/mL and 120.6 ± 28.5 ng*h/mL) did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle.
The impact of tazarotene on the pharmacokinetics of progestin only oral contraceptives (i.e., minipills) has not been evaluated.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/22/2014
Additional Tazorac Cream Information
Tazorac Cream - User Reviews
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