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Atralin

Last reviewed on RxList: 12/28/2016
Atralin Side Effects Center

Last reviewed on RxList 11/20/2015

Atralin (tretinoin) Gel is a topical (for the skin) form of vitamin A used to treat acne. Some brands of tretinoin gel are used to reduce the appearance of fine wrinkles and mottled skin discoloration, and to make rough facial skin feel smoother. Common side effects of Atralin Gel include a brief sensation of warmth or stinging immediately after applying Atralin. Skin redness, dryness, itching, scaling, mild burning, warmth, stinging, tingling, swelling, peeling, irritation, discoloration of skin, or worsening of acne may occur during the first 2-4 weeks of using Atralin Gel . These side effects usually decrease with continued use.

Atralin Gel is applied once daily, before bedtime, to the skin where acne lesions appear, using a thin layer to cover the entire affected area. Atralin Gel should be kept away from the eyes, the mouth, paranasal creases, and mucous membranes. Do not use Atralin with skin products that contain benzoyl peroxide, sulfur, resorcinol, or salicylic acid unless directed by your doctor. Atralin may interact with diuretics (water pills), antibiotics, sulfa drugs, chlorpromazine, prochlorperazine, fluphenazin, promethazine, or perphenazine. Tell your doctor all prescription and over-the-counter medications you use. Atralin is not recommended for use during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Atralin (tretinoin) Gel Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Atralin Consumer Information

Stop using this medication and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include burning, warmth, stinging, tingling, itching, redness, swelling, dryness, peeling, irritation, or discolored skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Atralin (Tretinoin)

Atralin Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under prescribing 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 practice.

In two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Atralin Gel [see Clinical Trials]. In these studies, 50% of the subjects who were treated with Atralin Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions. In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction; 5% of the subjects reported events that were treatment-related. There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups.

Selected adverse reactions that occurred in at least 1% of subjects in the two trials combined are shown in Table 1 (below). Most skin-related adverse reactions first appear during the first two weeks of treatment with Atralin Gel, and the incidence rate for skin-related reactions peaks around the second and third week of treatment. In some subjects the skin-related adverse reactions persists throughout the treatment period.

Table 1: Number of Subjects with Selected Adverse Reactions (Occurring in At Least 1% of Subjects)

Event Atralin Gel
(n = 674)
Vehicle Gel
(n = 487)
Dry Skin 109 (16%) 8 (2%)
Peeling/Scaling/ Flaking Skin 78 (12%) 7 (1%)
Skin Burning Sensation 53 (8%) 8 (2%)
Erythema 47 (7%) 1 ( < 1%)
Pruritus 11 (2%) 3 (1%)
Pain of Skin 7 (1%) 0 (0%)
Sunburn 7 (1%) 3 (1%)

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Atralin Gel. 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.

Temporary hyper-or hypopigmentation has been reported with repeated application of tretinoin.

Read the entire FDA prescribing information for Atralin (Tretinoin)

Related Resources for Atralin

Read the Atralin User Reviews »

© Atralin Patient Information is supplied by Cerner Multum, Inc. and Atralin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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