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Tazorac

Last reviewed on RxList: 5/18/2018
Tazorac Side Effects Center

Last reviewed on RxList 5/18/2018

Tazorac (tazarotene) Gel is a compound similar to vitamin A used to treat plaque psoriasis (psoriasis with scaly patches) and to treat facial acne. The Avage brand of tazarotene cream is used to reduce the appearance of fine wrinkles on the face, mottled light and dark skin patches on the face, and benign facial lentigines (noncancerous freckles). Common side effects of Tazorac Gel include:

  • itching,
  • redness,
  • irritation,
  • burning/stinging,
  • scaling,
  • dry skin,
  • peeling, or
  • pain at application site, and
  • skin sensitivity to sunlight.

Tell your doctor if you have serious side effects of Tazorac Gel including:

  • severe skin irritation (burning, stinging, itching) after application;
  • severe redness or discomfort; or
  • swelling, warmth, oozing, or other signs of skin infection.

To treat psoriasis, the recommended starting dose of Tazorac is 0.05% gel, with strength increased to 0.1% if tolerated and indicated. Apply a dose of Tazorac Gel once a day, in the evening, to psoriatic lesions, using enough (2 mg/cm²) to cover only the lesion with a thin film to no more than 20% of body surface area. To treat acne, after cleansing the face, apply a thin film dose of Tazorac Gel 0.1% (2 mg/cm²) once a day, in the evening, to the skin where acne lesions appear. Tazorac may interact with other topical products that have a drying effect, diuretics, antibiotics, or phenothiazines. Tell your doctor all medications and supplements you use. Tazorac must not be used during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, inform your doctor. Women should have a negative pregnancy test within 2 weeks of starting this medication and also start this medication during their normal period. It is recommended that men and women using this medication use two forms of birth control (e.g., condoms and birth control pills) while taking this medication; consult your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Tazorac (tazarotene) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Types of Psoriasis: Medical Pictures and Treatments See Slideshow
Tazorac Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using tazarotene topical and call your doctor at once if you have:

  • severe skin irritation (pain, dryness, flaking, peeling, burning, stinging, itching) after applying the medicine;
  • blistering or peeling skin;
  • severe redness or discomfort; or
  • swelling, warmth, oozing, or other signs of skin infection.

Common side effects may include:

  • dry, scaly, or peeling skin;
  • skin pain, redness or burning; or
  • itching or other irritation of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tazorac (Tazarotene Gel)

QUESTION

Psoriasis causes the top layer of skin cells to become inflamed and grow too quickly and flake off. See Answer
Tazorac Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in more detail in other sections of the labeling:

  • Embryofetal toxicity [see WARNINGS AND PRECAUTIONS]
  • Photosensitivity and Risk of Sunburn [see WARNINGS AND PRECAUTIONS]

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.

Psoriasis

A total of 439 subjects 14 to 87 years of age were treated with TAZORAC Gel, 0.05% and 0.1% in two controlled clinical trials. The most frequent adverse events reported with TAZORAC Gel, 0.05% and 0.1% occurring in 10 to 30% of subjects, in descending order, included pruritus, burning/stinging, erythema, worsening of psoriasis, irritation, and skin pain. Reactions occurring in 1 to 10% of subjects 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 subjects over the 4th to 12th months of treatment as compared to the first three months of a 1 year study. In general, the incidence of adverse events with TAZORAC Gel 0.05% was 2 to 5% lower than that seen with TAZORAC Gel 0.1%.

Acne

A total of 596 subjects 12 to 44 years of age were treated with TAZORAC Gel, 0.05% and 0.1% in two controlled clinical trials. The most frequent adverse events reported during clinical trials with TAZORAC Gel, 0.1% in the treatment of acne occurring in 10 to 30% of subjects, in descending order, included desquamation, burning/stinging, dry skin, erythema and pruritus. Reactions occurring in 1 to 10% of subjects included irritation, skin pain, fissuring, localized edema and skin discoloration.

Postmarketing Experience

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. The following adverse reactions have been identified during postapproval use of tazarotene.

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.

Read the entire FDA prescribing information for Tazorac (Tazarotene Gel)

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