In human dermal safety studies, tazarotene 0.05% and 0.1% gels did not induce
allergic contact sensitization, phototoxicity or photoallergy.
Psoriasis
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%.
Acne
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.
Postmarketing Experience
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.