Ultravate Side Effects
Generic Name: halobetasol topical
Note: This page contains side effects data for the generic drug halobetasol topical. It is possible that some of the dosage forms included below may not apply to the brand name Ultravate.
It is possible that some side effects of Ultravate may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
For the Consumer
Applies to halobetasol topical: topical application cream, topical application ointment
As well as its needed effects, halobetasol topical (the active ingredient contained in Ultravate) may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking halobetasol topical, check with your doctor immediately: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
- 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
- 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 halobetasol topical side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:Less common
- Acne or pimples
- burning and itching of the skin with pinhead-sized red blisters
- 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
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.[Ref]
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.[Ref]
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.[Ref]
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.[Ref]
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.
1. Goldberg B, Hartdegen R, Presbury D, Smith EH, Yawalkar S "A double-blind, multicenter comparison of 0.05% halobetasol propionate ointment and 0.05% clobetasol propionate ointment in patients with chronic, localized plaque psoriasis." J Am Acad Dermatol 25 (1991): 1145-8
2. Datz B, Yawalkar S "A double-blind, multicenter trial of 0.05% halobetasol propionate ointment and 0.05% clobetasol 17-propionate ointment in the treatment of patients with chronic, localized atopic dermatitis or lichen simplex chronicus." J Am Acad Dermatol 25 (1991): 1157-60
3. Yawalkar SJ, Schwerzmann L "Double-blind, comparative clinical trials with halobetasol propionate cream in patients with atopic dermatitis." J Am Acad Dermatol 25 (1991): 1163-6
4. "Product Information. Ultravate (halobetasol)." Bristol-Myers Squibb, Princeton, NJ.
5. Mensing H, Korsukewitz G, Yawalkar S "A double-blind, multicenter comparison between 0.05% halobetasol propionate ointment and 0.05% betamethasone dipropionate ointment in chronic plaque psoriasis." J Am Acad Dermatol 25 (1991): 1149-52
6. Watson WA, Kalb RE, Siskin SB, Freer JP, Krochmal L "The safety of halobetasol 0.05% ointment in the treatment of psoriasis [published erratum appears in Pharmacotherapy 1991;11(3):preceding Table of Contents]." Pharmacotherapy 10 (1990): 107-11
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