Retin-A Side Effects

Please note - some side effects for Retin-A may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Retin-A - for the consumer

Retin-A Cream

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Retin-A Cream:

Redness, peeling, or feeling of warmth; sensitivity to sunlight; skin irritation; stinging at application site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe redness, swelling, blistering, or crusting of the skin.

Retin-A Gel

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Retin-A Gel:

Redness, peeling at application site; sensitivity to sunlight; skin irritation; warmth or stinging at application site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe redness, peeling, swelling, blistering, or crusting of the skin.

Retin-A Liquid

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Retin-A Liquid:

Redness, peeling at application site; sensitivity to sunlight; skin irritation; warmth or stinging at application site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in skin color; severe redness, peeling, swelling, blistering, or crusting of the skin.

For the professional

Retin-A

Irritation Potential:

Acne clinical trial results: In separate clinical trials for each concentration, acne patients treated with Retin-A Micro (tretinoin gel) microsphere 0.1% or 0.04%, analysis over the twelve week period showed that cutaneous irritation scores for erythema, peeling, dryness, burning/stinging, or itching peaked during the initial two weeks of therapy, decreasing thereafter.

Approximately half of the patients treated with Retin-A Micro 0.04% had cutaneous irritation at Week 2. Of those patients who did experience cutaneous side effects, most had signs or symptoms that were mild in severity (severity was ranked on a 4-point ordinal scale: 0=none, 1=mild, 2=moderate, and 3=severe). Less than 10% of patients experienced moderate cutaneous irritation and there was no severe irritation at Week 2.

In studies on Retin-A Micro (tretinoin gel) microsphere, 0.04%, throughout the treatment period the majority of patients experienced some degree of irritation (mild, moderate, or severe) with 1% (2/225) of patients having scores indicative of a severe irritation rating; and 1.3% (3/225) of patients treated with Retin-A Micro (tretinoin gel) microsphere, 0.04%, discontinued treatment due to irritation, which included dryness in one patient and peeling and urticaria in another.

In studies on Retin-A Micro (tretinoin gel) microsphere, 0.1%, no more than 3% of patients had cutaneous irritation scores indicative of a severe irritation rating; although, 6% (14/224) of patients treated with Retin-A Micro (tretinoin gel) microsphere, 0.1% discontinued treatment due to irritation. Of these 14 patients, four had severe irritation after 3 to 5 days of treatment, with blistering in one patient.

Results in studies of subjects without acne: In a half-face comparison trial conducted for up to 14 days in women with sensitive skin, but without acne, Retin-A Micro (tretinoin gel) microsphere, 0.1% was statistically less irritating than tretinoin cream, 0.1%. In addition, a cumulative 21 day irritation evaluation in subjects with normal skin showed that Retin-A Micro (tretinoin gel) microsphere, 0.1%, had a lower irritation profile than tretinoin cream, 0.1%. The clinical significance of these irritation studies for patients with acne is not established. Comparable effectiveness of Retin-A Micro (tretinoin gel) microsphere, 0.1% and tretinoin cream, 0.1%, has not been established. The lower irritancy of Retin-A Micro (tretinoin gel) microsphere, 0.1% in subjects without acne may be attributable to the properties of its vehicle. The contribution to decreased irritancy by the MICROSPONGE System has not been established. No irritation studies have been performed to compare Retin-A Micro (tretinoin gel) microsphere, 0.04%, with either Retin-A Micro (tretinoin gel) microsphere, 0.1%, or tretinoin cream, 0.1%.

The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate. However, efficacy has not been established for lower dosing frequencies.

True contact allergy to topical tretinoin is rarely encountered. Temporary hyper- or hypopigmentation has been reported with repeated application of tretinoin. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin.

Retin-A Cream, Gel, Liquid

The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate. True contact allergy to topical tretinoin is rarely encountered. Temporary hyper or hypopigmentation has been reported with repeated application of Retin-A. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with Retin-A. To date, all adverse effects of Retin-A have been reversible upon discontinuance of therapy.

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