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Tazarotene

Medically reviewed by Drugs.com. Last updated on May 20, 2020.

Pronunciation

(taz AR oh teen)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, External:

Avage: 0.1% (30 g [DSC]) [contains benzyl alcohol]

Tazorac: 0.05% (30 g [DSC], 60 g [DSC]) [contains benzyl alcohol]

Tazorac: 0.05% (30 g, 60 g) [contains benzyl alcohol, edetate disodium]

Tazorac: 0.1% (30 g, 60 g [DSC]) [contains benzyl alcohol]

Tazorac: 0.1% (60 g) [contains benzyl alcohol, edetate disodium]

Generic: 0.1% (30 g, 60 g)

Foam, External:

Fabior: 0.1% (50 g, 100 g)

Gel, External:

Tazorac: 0.05% (30 g, 100 g); 0.1% (30 g [DSC], 100 g [DSC]) [contains benzyl alcohol]

Tazorac: 0.1% (30 g, 100 g) [contains benzyl alcohol, edetate disodium]

Lotion, External:

Arazlo: 0.045% (45 g) [contains edetate (edta) disodium dihydrate, methylparaben, propylparaben]

Brand Names: U.S.

  • Arazlo
  • Avage [DSC]
  • Fabior
  • Tazorac

Pharmacologic Category

  • Acne Products
  • Keratolytic Agent
  • Retinoic Acid Derivative
  • Topical Skin Product, Acne

Pharmacology

Synthetic, acetylenic retinoid which modulates differentiation and proliferation of epithelial tissue and exerts some degree of anti-inflammatory and immunological activity

Absorption

Minimal following cutaneous application (≤6% of dose)

Distribution

Retained in skin for prolonged periods after topical application.

Metabolism

Prodrug, rapidly metabolized via esterase hydrolysis to an active metabolite (tazarotenic acid) following topical application and systemic absorption; tazarotenic acid undergoes further hepatic metabolism

Excretion

Urine and feces (as metabolites)

Onset of Action

Psoriasis: 1 week

Duration of Action

Therapeutic: Psoriasis: Effects have been observed for up to 3 months after a 3-month course of topical treatment

Half-Life Elimination

Cream, gel: ~81 hours (tazarotenic acid); Foam: 8.1 ± 3.7 hours

Protein Binding

>99% (tazarotenic acid)

Special Populations: Children

Arazlo: In patients 9 to <12 years of age, mean tazarotenic acid Cmax is ~2.4-fold higher and mean AUC (0-t) is ~2.3-fold higher compared to patients ≥12 years of age.

Use: Labeled Indications

Acne (Arazlo 0.045% lotion, Fabior, Tazorac 0.1% cream, Tazorac 0.1% gel): Topical treatment of acne vulgaris in patients ≥9 years of age (Arazlo) or ≥12 years of age.

Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines (Avage): Adjunctive agent for use in the mitigation (palliation) of facial fine wrinkling, facial mottled hyper- and hypopigmentation, and benign facial lentigines in patients ≥17 years of age who use comprehensive skin care and sunlight avoidance programs.

Psoriasis:

Tazorac 0.05% and 0.1% cream: Topical treatment of plaque psoriasis in patients ≥18 years of age.

Tazorac 0.05% and 0.1% gel: Topical treatment of stable plaque psoriasis of up to 20% body surface area involvement in patients ≥12 years of age.

Limitations of use: Does not eliminate or prevent wrinkles, repair sun-damaged skin, reverse photoaging, or restore more youthful or younger skin. Has not demonstrated a mitigating effect on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis. Safety and effectiveness for the prevention or treatment of actinic keratoses, skin neoplasms, or lentigo maligna has not been established. Safe and effective daily use >52 weeks is not known. Safety of gel use on more than 20% body surface area has not been established.

Contraindications

Hypersensitivity to tazarotene or any component of the formulation; women who are or may become pregnant

Documentation of allergenic cross-reactivity for retinoids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Note: In patients experiencing excessive pruritus, burning, skin redness, or peeling, discontinue until integrity of the skin is restored, or reduce dosing to an interval the patient is able to tolerate.

Acne: Topical:

Arazlo: Apply a thin layer to affected area once daily.

Fabior: Apply a small amount to affected area once daily in the evening.

Tazorac cream/gel 0.1%: Apply a thin layer (2 mg/cm2) to affected area once daily in the evening.

Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines: Topical: Avage: Apply a pea-sized amount to entire face once daily at bedtime.

Psoriasis: Topical: Tazorac cream/gel: Initial: 0.05%: Apply once daily to psoriatic lesions using enough (2 mg/cm2) to cover only the lesion with a thin film. May increase strength to 0.1% if tolerated and necessary.

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: In patients experiencing excessive pruritus, burning, skin redness, or peeling, discontinue until integrity of the skin is restored or reduce dosing to an interval the patient is able to tolerate.

Acne vulgaris:

Cream or gel: Children ≥12 years and Adolescents: Topical: Tazorac (0.1%): Apply as a thin film (2 mg/cm2) to affected area(s) once daily in the evening.

Foam: Children ≥12 years and Adolescents: Topical: Fabior (0.1%): Apply a small amount to affected area(s) once daily in the evening.

Lotion: Children ≥9 years and Adolescents: Topical: Arazlo (0.045%): Apply a thin layer to affected area(s) once daily.

Psoriasis:

Cream: Adolescents ≥18 years: Topical: Tazorac (0.05%): Initial: Apply a thin film (2 mg/cm2) to affected area once daily in the evening; may increase strength to 0.1% if tolerated and necessary.

Gel: Children ≥12 years and Adolescents: Topical: Tazorac (0.05%): Initial: Apply a thin film (2 mg/cm2) to affected area once daily in the evening; may increase strength to 0.1% if tolerated and necessary; apply to no more than 20% of the body surface area.

Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines: Adolescents ≥17 years: Topical: Cream: Avage (0.1%): Apply a pea-sized amount once daily at bedtime; lightly cover entire face including eyelids if desired.

Administration

For topical use only; not for oral, ophthalmic, or intravaginal use. Avoid eyes, mouth, paranasal creases, or other mucous membranes; rinse thoroughly with water if contact occurs. Do not cover treated areas with dressings or bandages. Do not apply to eczematous, abraded, broken, or sunburned skin. Use effective sunscreen and wear protective clothing during treatment. Wash hands after use.

Acne: Apply in evening after gently cleansing and drying face; apply enough to cover entire affected area.

Foam: Dispense a small amount of foam into palm of the hand. Use fingertips to lightly cover the entire affected area of the face and/or upper trunk with a thin layer; massage into skin until foam disappears. Moisturizer may be used if necessary.

Palliation of fine facial wrinkles, facial mottled hyper-/hypopigmentation, benign facial lentigines: Apply to clean dry face at bedtime; lightly cover entire face including eyelids if desired. Emollients or moisturizers may be applied before or after; ensure first cream or lotion has absorbed into the skin and has dried completely before applying tazarotene.

Psoriasis: Apply in evening. If a bath or shower is taken prior to application, dry the skin before applying. If emollients are used, apply them at least 1 hour prior to application. Unaffected skin may be more susceptible to irritation, avoid application to these areas.

Storage

Cream: Store at 25°C (77°F); excursions are permitted between -5°C to 30°C (23°F to 86°F).

Foam: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F). Store upright and protect from freezing. Foam is flammable; avoid fire, flame, or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 49°C (120°F).

Gel: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F).

Lotion: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C to 30°C (59°F to 86°F); protect from freezing.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Percentage of incidence varies with formulation and/or strength:

>10%: Dermatologic: Desquamation (0.1% cream 40%; foam 6%), erythema (0.1% cream 34%; foam 6%), burning sensation of skin (26%), xeroderma (7% to 16%), skin irritation (10% to 14%), exacerbation of psoriasis, skin pain

1% to 10%:

Cardiovascular: Peripheral edema

Dermatologic: Pruritus (0.1% cream 10%; foam 1%), contact dermatitis (8%), stinging of the skin (3%), skin rash (≤3%), cheilitis (1%), dermatitis (1%), skin photosensitivity (1%), eczema, skin discoloration, skin fissure

Endocrine & metabolic: Hypertriglyceridemia

Local: Application site pain (1%), local hemorrhage

Ophthalmic: Ocular irritation (including edema, irritation, and inflammation of the eye or eyelid; 4%)

Frequency not defined: Hypersensitivity: Hypersensitivity reaction, local hypersensitivity reaction

<1%, postmarketing, and/or case reports: Application site edema, exfoliation of skin, impetigo, pain, skin blister

Warnings/Precautions

Concerns related to adverse effects:

• Photosensitivity: May cause photosensitivity; exposure to ultraviolet rays (including sunlight/sunlamps) should be avoided unless deemed medically necessary, and in such cases, exposure should be minimized. Risk may be increased by concurrent therapy with known photosensitizers (thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides); use with caution. Use with caution in patients with a personal or family history of skin cancer. Daily sunscreen use and other protective measures recommended. Patients with sunburn should discontinue use until sunburn has healed.

• Skin irritation: Local tolerability reactions (including blistering or skin desquamation) or local hypersensitivity reactions (including urticaria) may occur. Application-site pain, excessive burning, drying, pruritus, peeling, and skin redness may occur, especially during the early weeks of treatment. Treatment can increase skin sensitivity to weather extremes of wind or cold. Concomitant topical medications (eg, medicated or abrasive soaps, cleansers, cosmetics with a strong drying effect) should be avoided due to increased skin irritation. Depending on the severity of the reaction, instruct patients to use a moisturizer, reduce the frequency of use, or discontinue use.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.

• Foam: Propellant is flammable; avoid fire and smoking during and immediately after use.

• Gel: Safety and efficacy of gel applied over >20% of BSA have not been established.

Other warnings/precautions:

• Appropriate use: For external use only; avoid contact with eyes, eyelids, and mouth. Not for use on eczematous, abraded, broken, or sunburned skin; not for treatment of lentigo maligna. Avoid application over extensive areas. The efficacy of tazarotene gel in the treatment of acne previously treated with other retinoids or resistant to oral antibiotics has not been established.

Monitoring Parameters

Disease severity in plaque psoriasis during therapy (reduction in erythema, scaling, induration); clinical response and skin tolerance. Evaluate pregnancy status prior to use in females of reproductive potential.

Reproductive Considerations

Evaluate pregnancy status prior to use in females of reproductive potential. A negative pregnancy test should be obtained within 2 weeks prior to treatment; treatment should begin during a normal menstrual period. Adequate contraception should be used in females of reproductive potential.

Pregnancy Considerations

Use in pregnancy is contraindicated.

Inadvertent exposure to a limited number of pregnant women occurred during premarketing studies; however, the available data are inadequate to evaluate outcomes. Based on data from animal reproduction studies, retinoid pharmacology, and the potential for systemic absorption, in utero exposure to tazarotene may cause fetal harm.

Topical products are recommended as initial therapy for the treatment of acne or psoriasis in pregnant women. Because the safety of tazarotene is uncertain, use during pregnancy is contraindicated (Bae 2012; Chien 2016; Kong 2013).

Patient Education

What is this drug used for?

• It is used to treat pimples (acne).

• It is used to treat plaque psoriasis.

• It is used to lower the number of wrinkles and liver spots.

• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dry skin

• Stinging

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Sunburn

• Swelling

• Peeling

• Redness

• Burning

• Itching

• Skin irritation

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Frequently Asked Questions