Halonate 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 Halonate.

Some side effects of Halonate 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 cream, topical kit, topical ointment

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

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 halobetasol 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 halobetasol topical may include:

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

• thinning or softening of your skin;

• skin rash or irritation around your mouth;

• swollen hair follicles;

• spider veins;

• numbness or tingling;

• 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. Call your doctor for medical advice about side effects.

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.

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