What is Tazorac (tazarotene)?

Tazorac (tazarotene) is retinoid used topically (on the skin) to treat acne and psoriasis. The exact mechanism of how Tazorac works is not known. Scientists believe that when Tazorac is applied to the skin, it affects the growth of skin cells and thereby reduces the formation of pimples and psoriasis plaques. 

Tazorac may affect growth of skin cells by affecting the action of genes that control production of skin cells. It also reduces inflammation. Tazorac was withdrawn from the U.S. market in 2007, but is available on a very limited basis for restricted use. Women who would like to be considered for this medication should contact their doctor for an evaluation.

Common side effects of Tazorac include:

  • dry skin,
  • redness,
  • stinging and burning,
  • irritation,
  • itching,
  • skin peeling, and
  • sun sensitivity.

Serious side effects of Tazorac include:

Drug interactions of Tazorac include medications or cosmetics that have a strong drying effect on the skin. 

Tazorac can cause birth defects. Pregnant women should not use Tazorac. Women of reproductive potential should use effective birth control to prevent pregnancy

It may not be safe to breastfeed while using this Tazorac. Consult your doctor before breastfeeding

What are the important side effects of Tazorac (tazarotene)?

Side effects of Tazarotene are:

  • dry skin,
  • redness,
  • stinging and burning,
  • irritation,
  • itching,
  • desquamation, and
  • sun sensitivity.

Tazorac (tazarotene) side effects list for healthcare professionals

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

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:

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:

What drugs interact with Tazorac (tazarotene)?

No formal drug-drug interaction studies were conducted with Tazorac Gel.

In a trial of 27 healthy female subjects between the ages of 20-55 years receiving a combination oral contraceptive tablet containing 1 mg norethindrone and 35 mcg ethinyl estradiol, concomitant use of tazarotene administered as 1.1 mg orally (mean ± SD Cmax and AUC0-24 of tazarotenic acid were 28.9 ± 9.4 ng/mL and 120.6 ± 28.5 ng•hr/mL, respectively) did not affect the pharmacokinetics of norethindrone and ethinyl estradiol over a complete cycle.

The impact of tazarotene on the pharmacokinetics of progestin only oral contraceptives (i.e., minipills) has not been evaluated.

Summary

Tazorac (tazarotene) is retinoid used topically (on the skin) to treat acne and psoriasis. Common side effects of Tazorac include dry skin, redness, stinging and burning, irritation, itching, skin peeling, and sun sensitivity. Serious side effects of Tazorac include severe skin irritation (stinging, burning, itching) after applying the medicine, severe redness or discomfort, blistering or peeling skin, and warmth, swelling, oozing, or other signs of skin infection. Tazorac can cause birth defects. Pregnant women should not use Tazorac. Women of reproductive potential should use effective birth control to prevent pregnancy. It may not be safe to breastfeed while using this Tazorac. Consult your doctor before breastfeeding.

Treatment & Diagnosis

Medications & Supplements

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Medically Reviewed on 5/12/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.
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