In human dermal safety studies, tazarotene 0.05% and 0.1% gels did not induce allergic contact sensitization, phototoxicity or photoallergy.
The most frequent adverse events reported with TAZORAC® (tazarotene gel) Gel 0.05% and 0.1% were limited to the skin. Those occurring in 10 to 30% of patients, in descending order, included pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, and skin pain. Events occurring in 1 to 10% of patients included rash, desquamation, irritant contact dermatitis, skin inflammation, fissuring, bleeding, and dry skin. Increases in “psoriasis worsening” and “sun-induced erythema” were noted in some patients over the 4th to 12th months as compared to the first three months of a 1 year study. In general, the incidence of adverse events with TAZORAC® (tazarotene gel) Gel 0.05% was 2 to 5% lower than that seen with TAZORAC® (tazarotene gel) Gel 0.1%.
The most frequent adverse events reported with TAZORAC® (tazarotene gel) Gel 0.1% in the treatment of acne occurring in 10 to 30% of patients, in descending order, included desquamation, burning/stinging, dry skin, erythema and pruritus. Events occurring in 1 to 10% of patients included irritation, skin pain, fissuring, localized edema and skin discoloration.
The following adverse reactions have been identified during postmarketing use of TAZORAC® (tazarotene gel) Gel 0.05% and 0.1% in clinical practice. Because they are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to TAZORAC® (tazarotene gel) Gel. The reactions include: blister, rash, skin discoloration (including skin hyperpigmentation or skin hypopigmentation), and pain.
Read the Tazorac (tazarotene gel) Side Effects Center for a complete guide to possible side effects »
Concomitant dermatologic medications and cosmetics that have a strong drying effect should be avoided. It is also advisable to “rest” a patient's skin until the effects of such preparations subside before use of TAZORAC® (tazarotene gel) Gel is begun.
In a study 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 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.
Last reviewed on RxList: 4/19/2011
This monograph has been modified to include the generic and brand name in many instances.
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