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 application cream, topical application emollient cream, topical application foam, topical application gel/jelly, topical application lotion, topical application ointment, topical application shampoo, topical application solution, topical application spray

Along with its needed effects, clobetasol topical (the active ingredient contained in Embeline) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking clobetasol topical:

More common
  • Burning or stinging at the application site
Less common
  • Burning sensation of the skin
  • dry skin
  • flushing or redness of the skin
  • itching, scaling, severe redness, soreness, or swelling of the skin
  • skin irritation
  • skin rash, encrusted, scaly and oozing
  • thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)
Incidence not known
  • Burning, itching, and pain in hairy areas, or pus at the root of the hair
  • hair loss
  • redness and scaling around the mouth
  • thinning of the hair
  • thinning, weakness, or wasting away of the skin

Some side effects of clobetasol topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Cough
  • sore throat
Less common
  • Body aches or pain
  • changes in skin coloring
  • congestion or cough
  • dryness or soreness of the throat
  • headache
  • raised, dark red, wart-like spots on the skin, especially when used on the face
  • skin discomfort
  • stuffy or runny nose
  • tender, swollen glands in the neck
  • trouble swallowing
  • unusual tiredness or weakness
  • voice changes
Incidence not known
  • Acne or pimples
  • burning and itching of the skin with pinhead-sized red blisters
  • increased hair growth on the forehead, back, arms, and legs
  • lightening of normal skin color
  • lightening of treated areas of dark skin
  • reddish purple lines on the arms, face, legs, trunk, or groin
  • softening of the skin

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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