Tazarotene
Generic: TAZAROTENE
Basic Information
Manufacturer
Sun Pharmaceutical Industries, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
478ff059-9d7b-438e-a64e-c853dfac2872
Indications & Usage
1 INDICATIONS AND USAGE Tazarotene cream 0.1% is a retinoid indicated for the topical treatment of plaque psoriasis.
( 1.1 ) Tazarotene cream 0.1% is indicated for the topical treatment of acne vulgaris.
( 1.2 ) 1.1 Plaque Psoriasis Tazarotene cream, 0.1% is indicated for the topical treatment of patients with plaque psoriasis.
1.2 Acne Vulgaris Tazarotene cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.
( 1.1 ) Tazarotene cream 0.1% is indicated for the topical treatment of acne vulgaris.
( 1.2 ) 1.1 Plaque Psoriasis Tazarotene cream, 0.1% is indicated for the topical treatment of patients with plaque psoriasis.
1.2 Acne Vulgaris Tazarotene cream, 0.1% is also indicated for the topical treatment of patients with acne vulgaris.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail in other sections of the labeling: Embryofetal toxicity [see Warnings and Precautions (5.1) ] Photosensitivity and Risk of Sunburn [see Warnings and Precautions (5.3) ] Plaque psoriasis: Most common adverse reactions occurring in 10 to 23% of patients are pruritus, erythema, and burning.
( 6.1 ) Acne Vulgaris: Most common adverse reactions occurring in 10 to 30% of patients are desquamation, dry skin, erythema, and burning sensation.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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, tazarotene cream, 0.05% and 0.1% did not induce allergic contact sensitization, phototoxicity, or photoallergy.
Psoriasis The most frequent adverse reactions reported with tazarotene 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.
Tazarotene 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 tazarotene cream, 0.1% were 0.1 to 0.4% higher than those reported for tazarotene cream, 0.05%.
Acne The most frequent adverse reactions reported during clinical trials with tazarotene cream 0.1% in the treatment of acne, occurring in 10 to 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.
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of tazarotene.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: blister, dermatitis, urticaria, skin exfoliation, skin discoloration (including skin hyperpigmentation or skin hypopigmentation), swelling at or near application sites, and pain.
( 6.1 ) Acne Vulgaris: Most common adverse reactions occurring in 10 to 30% of patients are desquamation, dry skin, erythema, and burning sensation.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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, tazarotene cream, 0.05% and 0.1% did not induce allergic contact sensitization, phototoxicity, or photoallergy.
Psoriasis The most frequent adverse reactions reported with tazarotene 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.
Tazarotene 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 tazarotene cream, 0.1% were 0.1 to 0.4% higher than those reported for tazarotene cream, 0.05%.
Acne The most frequent adverse reactions reported during clinical trials with tazarotene cream 0.1% in the treatment of acne, occurring in 10 to 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.
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of tazarotene.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and subcutaneous tissue disorders: blister, dermatitis, urticaria, skin exfoliation, skin discoloration (including skin hyperpigmentation or skin hypopigmentation), swelling at or near application sites, and pain.