Olux Side Effects

Please note - some side effects for Olux 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 Olux - for the Consumer

Olux-E Emollient Foam

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 Olux-E Emollient Foam:

Burning or mild skin irritation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, peeling, or swelling not present before you began using Olux-E Emollient Foam; inflamed hair follicles; inflammation around the mouth; muscle weakness; numbness of the fingers; symptoms of high blood sugar (eg, confusion; flushing; increased hunger, thirst, or urination; rapid breathing; unusual drowsiness); thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

Olux Foam

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 Olux Foam:

Dryness, burning, or mild skin irritation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, peeling, or swelling not present before you began using Olux Foam; inflamed hair follicles; inflammation around the mouth; muscle weakness; numbness of the fingers; symptoms of high blood sugar (eg, confusion; flushing; increased hunger, thirst, or urination; rapid breathing; unusual drowsiness); thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

Olux/Olux-E Complete Pack Foam

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 Olux/Olux-E Complete Pack Foam:

Dryness, burning, or mild skin irritation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, peeling, or swelling not present before you began using Olux/Olux-E Complete Pack Foam; inflamed hair follicles; inflammation around the mouth; muscle weakness; numbness of the fingers; symptoms of high blood sugar (eg, confusion; flushing; increased hunger, thirst, or urination; rapid breathing; unusual drowsiness); thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

Olux Side Effects - for the Professional

Olux

In a controlled pharmacokinetic study, 5 of 13 subjects experienced reversible suppression of the adrenals at any time during the 14 days of Olux Foam therapy to at least 20% of the body surface area. Of the 13 subjects studied, 1 of 9 with psoriasis were suppressed after 14 days and all 4 of the subjects with atopic dermatitis had abnormal cortisol levels indicative of adrenal suppression at some time after starting therapy with Olux Foam.

Systemic absorption of topical corticosteroids has produced reversible adrenal suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

In a controlled clinical trial (188 subjects) with Olux Foam in subjects with psoriasis of the scalp, there were no localized scalp adverse reactions reported in the Olux Foam treated subjects. In two controlled clinical trials (360 subjects) with Olux Foam in subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the Olux Foam treated subjects included application site burning (10%), application site dryness (< 1%), and other application site reactions (4%).

In larger controlled trials with other clobetasol propionate formulations, the most frequently reported local adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, skin atrophy, and telangiectasia (all less than 2%).

The following additional local adverse reactions have been reported with topical corticosteroids, but they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids such as Olux Foam. These reactions are listed in an approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, and miliaria.

Side Effects by Body System

Local

Local side effects have commonly included burning, itching, dryness, or irritation, especially if applied to denuded skin. Long-term use of topical corticosteroids has resulted in skin atrophy and thinning, and the development of striae, telangiectasias, subcutaneous hemorrhage, and easy bruising and bleeding. Allergic contact dermatitis has been occasionally reported.

Skin atrophy may become evident within one to two months of use. Atrophy is due to the inhibitory effect of corticosteroids on collagen formulation. Skin on the face, axilla, and groin appears to be most susceptible to the adverse long-term effects of topical clobetasol. Use of high potency topical corticosteroids on these areas should be minimized or avoided.

Topical corticosteroid use may impair the local immune response, rendering skin more susceptible to infection. Folliculitis is occasionally reported.

Perioral dermatitis or rosacea-like dermatitis has occurred in patients with seborrheic skin types who were treated with potent topical corticosteroids. This condition may flare temporarily upon discontinuation of topical steroids, prompting patients to continue their use. If topical corticosteroids are discontinued, this flare and the initial dermatitis generally resolves over a few weeks.

Worsening of psoriasis has occurred in a few patients.

Endocrine

Endocrinologic side effects have included suppression of the hypothalamic-pituitary-adrenal (HPA) axis. Withdrawal of therapy has resulted in the development of cushingoid features and symptoms of adrenal suppression. This was more likely when higher potency topical corticosteroids were used over extensive areas and when occlusive dressings were used. In addition, the gel and emollient cream formulation of clobetasol provided better penetration, and thus, higher risk of adrenal suppression.

Adrenal suppression has been reported in patients with psoriasis using doses of less than 50 grams per week, although this dosage is generally considered to be safe. Adrenal suppression has been reported in at least one patient receiving 7.5 grams per week. Plasma cortisol concentrations generally return to normal within one to two weeks following discontinuation of the drug. In a few cases adrenal failure persisted up to four months.

If clobetasol is to be used for an extended period of time, adrenal function should be evaluated periodically. Supplemental systemic steroids may be necessary during times of stress.

Ocular

Ocular side effects have rarely included glaucoma in patients using clobetasol on the face for long periods of time. Intraocular pressure did not always return to normal following discontinuation of the drug.

Musculoskeletal

Musculoskeletal side effects have included rare reports of osteoporosis with long term use. Vertebral fractures and avascular necrosis of the hips have been documented.

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