Embeline Side Effects

Generic name: clobetasol topical

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

Some side effects of Embeline may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to clobetasol topical: topical cream, topical foam, topical gel, topical lotion, topical ointment, topical shampoo, topical solution, topical spray

Get emergency medical help if you have any of these signs of an allergic reaction while taking clobetasol topical (the active ingredient contained in Embeline) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when clobetasol topical is applied to the skin, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing clobetasol topical through your skin, such as:

• blurred vision, or seeing halos around lights;

• mood changes;

• sleep problems (insomnia);

• weight gain, puffiness in your face; or

• muscle weakness, feeling tired.

Less serious side effects of clobetasol topical may include:

• mild skin rash, itching, burning, or redness;

• dry or cracking skin;

• thinning or softening of your skin;

• skin rash or irritation around your mouth;

• swollen hair follicles;

• temporary hair loss;

• spider veins;

• changes in color of treated skin;

• blisters, pimples, or crusting of treated skin; or

• stretch marks.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to clobetasol topical: compounding powder, topical cream, topical foam, topical gel, topical lotion, topical ointment, topical shampoo, topical solution, topical spray

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.

Dermatologic

Dermatologic side effects have included postmarketing reports of erythema, pruritus, burning, alopecia, and dryness.

Other

Pediatric:
Frequency not reported: HPA axis suppression (low plasma cortisol levels, absence of response to ACTH stimulation), Cushing's syndrome, linear growth retardation, delayed weight gain, intracranial hypertension (bulging fontanelles, headaches, bilateral papilledema), striae (with inappropriate use in infants and children).

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