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warnings
WARNINGS Pregnancy Category X. See CONTRAINDICATIONS section. Women of child-bearing potential should be warned of the potential risk and use adequate birth-control measures when TAZORAC ® Cream is used. The possibility that a woman of child-bearing potential is pregnant at the time of institution of therapy should be considered. A negative result for pregnancy test having a sensitivity down to at least 50 milli International Units per mL for hCG should be obtained within 2 weeks prior to TAZORAC ® Cream therapy, which should begin during a normal menstrual period.
ADVERSE REACTIONS In human dermal safety studies, tazarotene 0.05% and 0.1% creams did not induce allergic contact sensitization, phototoxicity, or photoallergy. Psoriasis The most frequent adverse events reported with TAZORAC ® 0.05% and 0.1% creams were limited to the skin. Those occurring in 10 to 23% of patients, in descending order, included pruritus, erythema, and burning. Events occurring in greater than 1 to less than 10% of patients, 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. Tazarotene cream 0.1% was associated with a somewhat greater degree of local irritation than the 0.05% cream. In general, the rates of irritation adverse events reported during psoriasis studies with TAZORAC ® 0.1% Cream were 1 to 4 percentage points higher than those reported for TAZORAC ® 0.05% Cream. Acne The most frequent adverse reactions reported during clinical trials with TAZORAC ® Cream 0.1% in the treatment of acne, occurring in 10-30% of patients, in descending order included desquamation, dry skin, erythema, and burning sensation. Events occurring in 1 to 5% of patients included pruritus, irritation, face pain, and stinging.