Atralin Side Effects

Generic Name: tretinoin topical

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

Not all side effects for Atralin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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.

In addition to its needed effects, some unwanted effects may be caused by tretinoin topical (the active ingredient contained in Atralin). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking tretinoin topical, check with your doctor or nurse as soon as possible:

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 of the side effects that can occur with tretinoin topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

A severe cutaneous reaction was reported in a patient who had an ice pack placed over an area treated with topical tretinoin. The area became pigmented and indurated, and the pigmentation persisted for an extensive length of time.[Ref]

Dermatologic side effects are the most frequently reported side effects with the use of tretinoin topical. In double-blind, vehicle-controlled studies involving 339 patients who applied tretinoin topical 0.02% to their faces, adverse reactions associated with the use of tretinoin topical were limited primarily to the skin. Almost all patients reported one or more local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus. In 24% of all study patients, skin irritation was reported that was either severe (about 7%), led to temporary discontinuation of tretinoin topical 0.02% (about 20%), or led to use of a mild topical corticosteroid. About 5% of patients using tretinoin topical 0.02%, compared to less than 1% of the control patients, had sufficiently severe local irritation to warrant short-term use of mild topical corticosteroids to alleviate local irritation. About 4% of patients had to discontinue use of tretinoin topical because of adverse reactions. Tretinoin may induce photosensitivity in some individuals, as well as an increased susceptibility to irritation from wind, cold, and dryness.[Ref]

Local

Local side effects including a retinoid dermatitis has been reported to occur frequently at the areas treated with topical tretinoin and is characterized by erythema, dryness, scaling, pruritus, and variable degrees of irritation.[Ref]

Local reaction is commonly observed during the initial phase of therapy, but may not appear until as late as ten weeks into treatment. The dermatitis generally subsides with prolonged use of the medication, although in some cases may require a dosage adjustment or discontinuation of therapy. True contact dermatitis has been reported and confirmed with patch testing and leukocyte migration inhibition studies, but is uncommon. Rarely, there may be temporary hyper- or hypopigmentation following repeated applications.[Ref]

Ocular

Ocular side effects including ectropions may develop infrequently and are reversible. A transient and harmless stinging of the eye may occur when tretinoin is applied onto the surrounding skin, generally lasting about 30 to 60 seconds.[Ref]

Hepatic

Hepatic side effects including reversible, clinically insignificant changes in liver function tests have been reported following both oral and topical administration of tretinoin. These abnormalities include elevations in serum bilirubin, alkaline phosphatase, glutamic-oxaloacetic transaminase, and glutamic-pyruvic transaminase.[Ref]

Nervous system

Nervous system side effects including a case of neurotoxicity in a patient with liver disease have been reported.[Ref]

The patient developed neurological side effects following 4 weeks of tretinoin administration. Symptoms included headache, memory loss, truncal ataxia, and dysarthria, all of which improved upon temporary discontinuation of medication and recurred when the patient resumed usage. Upon withdrawal of medication a second time, the symptoms resolved within 4 weeks.[Ref]

Genitourinary

Estrogen levels appeared not to have been affected.[Ref]

Genitourinary side effects including an isolated case of vaginal bleeding related to tretinoin use has been reported in a post-menopausal woman and confirmed upon rechallenge.[Ref]

References

1. Thomas JR 3d, Doyle JA "The therapeutic uses of topical vitamin A acid." J Am Acad Dermatol 4 (1981): 505-13

2. Kowal LM, Harper CA "Visual complications of warfarin." Med J Aust 176 (2002): 351

3. Rosenbluth M "Adverse reaction to retin-A." J Am Dent Assoc 119 (1989): 346

4. Heel RC, Brogden RN, Speight TM, Avery GS "Vitamin A acid: a review of its pharmacological properties and therapeutic use in the topical treatment of acne vulgaris." Drugs 14 (1977): 401-19

5. Weiss JS, Ellis CN, Goldfarb MT, Voorhees JJ "Tretinoin therapy: practical aspects of evaluation and treatment." J Int Med Res 18 Suppl 3 (1990): c41-8

6. Jordan WP Jr, Higgins M, Dvorak J "Allergic contact dermatitis to All-trans-retinoic acid; epicutaneous and leukocyte migration inhibition testing." Contact Dermatitis 1 (1975): 306-10

7. Tosti A, Guerra L, Morelli R, Piraccini BM "Contact dermatitis due to topical retinoic acid." Contact Dermatitis 26 (1992): 276-7

8. Brodell LP, Asselin D, Brodell RT "Reversible ectropion after long-term use of topical tretinoin on photodamaged skin." J Am Acad Dermatol 27 (1992): 621-2

9. Bernstein AL, Leventhal-Rochon JL "Neurotoxicity related to the use of topical tretinoin (Retin-A)." Ann Intern Med 124 (1996): 227-8

10. Meurehg CC, Xochitl Amelio P "Vaginal bleeding and tretinoin cream." Ann Intern Med 113 (1990): 483

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