Embeline Side Effects

Generic Name: clobetasol topical

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

Embeline 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 Embeline Cream:

Irritation; stinging.

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

Embeline 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 Embeline Gel:

Dryness; itching; mild burning.

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, or peeling not present before you began using Embeline Gel; dark red blotches on the skin; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; numbness of fingers; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

Embeline Solution

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 Embeline Solution:

Dryness; itching; mild burning or stinging.

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, or peeling not present before you began using Embeline Solution; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; numbness of fingers; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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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