Ultravate Side Effects

Generic Name: halobetasol topical

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

Some side effects of Ultravate 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 halobetasol topical: topical application cream, topical application ointment

Along with its needed effects, halobetasol topical (the active ingredient contained in Ultravate) 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 halobetasol topical:

Less common
  • Blisters under the skin
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • dry skin
  • flushing or redness of the skin
  • hives or welts
  • itching
  • rash
  • stinging
  • thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)
  • unusually warm skin
Incidence not known
  • Blistering, burning, crusting, dryness, or flaking of the skin
  • itching, scaling, severe redness, soreness, or swelling of the skin
  • redness and scaling around the mouth

Some side effects of halobetasol 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:

Less common
  • Acne or pimples
  • burning and itching of the skin with pinhead-sized red blisters
Incidence not known
  • Burning, itching, and pain in hairy areas, or pus at the root of the hair
  • 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

For Healthcare Professionals

Applies to halobetasol topical: topical cream, topical kit, topical ointment

Local

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

Topical corticosteroid use may inhibit local immune response rendering the skin more susceptible to infections. Folliculitis is occasionally reported.

Perioral dermatitis or rosacea-like dermatitis has occurred in patients treated with potent topical corticosteroids who are of seborrheic skin type. 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.

Local side effects have commonly included burning, itching, dryness, or irritation, especially when applied to denuded skin. These occurred in approximately 2% to 8% of patients treated. Long-term use of topical corticosteroids has resulted in skin atrophy and thinning, and the development of striae, telangiectasia, subcutaneous hemorrhage, and easy bruising and bleeding.

Endocrine

Endocrine side effects have included suppression the hypothalamic-pituitary-adrenal (HPA) axis and has resulted in Cushing's Syndrome and symptoms of adrenal suppression following withdrawal of the drug. This was more likely when higher potency topical corticosteroids were used over extensive areas and when occlusive dressing were used. In addition, the ointment formulation of halobetasol provided better penetration, and thus, higher risk of adrenal suppression.

Adrenal suppression has been reported in patients with psoriasis using doses of approximately 50 grams per week, although other patients have tolerated this dosage with no adrenal suppression. Dosages above this are generally not recommended. Plasma cortisol concentrations generally return to normal within one to two weeks following discontinuation of the drug.

If halobetasol 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.

Dermatologic

The most frequent adverse events reported include stinging, burning or itching in 4.4% of the patients for the cream, and stinging or burning in 1.6% of the patients for the ointment.

Less frequently reported adverse reactions were dry skin, erythema, skin atrophy, leukoderma, vesicles, rash for the cream, and pustulation, erythema, skin atrophy, leukoderma, acne, itching, secondary infection, telangiectasia, urticaria, dry skin, miliaria, paresthesia, rash for the ointment.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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