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® (tazarotene cream) 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 > 1 to < 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® (tazarotene cream) 0.1% Cream were 1
to 4 percentage points higher than those reported for TAZORAC® (tazarotene cream) 0.05% Cream.
Acne
The most frequent adverse reactions reported during clinical trials with TAZORAC® (tazarotene cream)
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.