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Atralin Side Effects

Generic Name: tretinoin topical

Note: This document contains side effect information about tretinoin topical. Some of the dosage forms listed on this page may not apply to the brand name Atralin.

In Summary

More frequent side effects include: exfoliation of skin, stinging of the skin, localized warm feeling, and mild erythema. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to tretinoin topical: topical cream, topical gel/jelly, topical liquid, topical solution

In some animal studies, tretinoin has been shown to cause skin tumors to develop faster when the treated area is exposed to ultraviolet light (sunlight or artificial sunlight from a sunlamp). Other studies have not shown the same result and more studies need to be done. It is not known if tretinoin causes skin tumors to develop faster in humans.

Along with its needed effects, tretinoin topical (the active ingredient contained in Atralin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking tretinoin topical:

More Common

  • Burning feeling or stinging skin (severe)
  • lightening of skin of treated area, unexpected
  • peeling of skin (severe)
  • redness of skin (severe)
  • unusual dryness of skin (severe)

Rare

  • Darkening of treated skin

Some side effects of tretinoin topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Burning feeling, stinging, or tingling of skin (mild)—lasting for a short time after first applying the medicine
  • chapping or slight peeling of skin (mild)
  • redness of skin (mild)
  • unusual dryness of skin (mild)
  • unusually warm skin (mild)

The side effects will go away after you stop using tretinoin. On the rare chance that your skin color changes, this effect may last for several months before your skin color returns to normal.

For Healthcare Professionals

Applies to tretinoin topical: topical cream, topical gel, topical kit, topical liquid

Dermatologic

Cream:

Very common (10% or more): Severe skin irritation (Up to 32%)

Frequency not reported: Mild irritation, peeling/skin exfoliation, erythema, pruritus, blistering, pain, crusting, tenderness, dry skin, burning/warmth/stinging, photosensitivity/increased sensitivity to light

Postmarketing reports: Temporary hyper/hypopigmentation, rash, skin atrophy

Gel:

Very common (10% or more): Dry skin (Up to 16%), peeling/scaling/flaking skin (Up to 12%)

Common (1% to 10%): Burning sensation, erythema, pruritus, skin pain, sunburn

Frequency not reported: Blistering/crusting skin

Postmarketing reports: Temporary hypo/hyperpigmentation, increased susceptibility to sunlight

Microsphere Gel:

Common (1% to 10%): Skin irritation, skin burning, erythema, dermatitis

Frequency not reported: Peeling, dryness, stinging, itching

Postmarketing reports: Temporary hypo/hyperpigmentation[Ref]

Erythema, peeling, dryness, burning/stinging, and/or itching occurred most frequently during the first 2 weeks of therapy.

Most of the dermatologic side effects were mild in severity (approximately 63%), and approximately 34% were of moderate severity.

Dry, peeling, scaling, and/or flaking skin occurred most often in the gel formulation.[Ref]

Hepatic

Cream:

Frequency not reported: Reversible liver function test changes (bilirubin, alkaline phosphatase, ALT, AST)[Ref]

Metabolic

Cream:

Frequency not reported: Thymol turbidity elevations, increased flocculation[Ref]

Cardiovascular

Cream:

Postmarketing reports: Edema/swelling of application site[Ref]

Hypersensitivity

Cream:

Frequency not reported: Allergic contact dermatitis

Postmarketing reports: Allergic reaction[Ref]

References

1. "Product Information. Retin-A (tretinoin)." Ortho Pharmaceutical Corporation, Raritan, NJ.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Renova (tretinoin topical)." Janssen Pharmaceuticals, Titusville, NJ.

4. "Product Information. Avita (tretinoin topical)." Penederm Inc, Foster City, CA.

Further information

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

Some side effects may not be reported. You may report them to the FDA.

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