Ultravate Side Effects

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

Ultravate 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 Ultravate Cream:

Dryness; mild stinging, burning, or itching.

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 Ultravate Cream; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

Ultravate PAC Ointment

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 Ultravate PAC Ointment:

Dryness; itching; mild, temporary burning, irritation, peeling, redness, sensitivity, 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 Ultravate PAC Ointment; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

Ultravate Side Effects - for the Professional

Ultravate

In controlled clinical trials, the most frequent adverse events reported for Ultravate Ointment included stinging or burning in 1.6% of the patients. Less frequently reported adverse reactions were pustulation, erythema, skin atrophy, leukoderma, acne, itching, secondary infection, telangiectasia, urticaria, dry skin, miliaria, paresthesia, and rash.

The following additional local adverse reactions are reported infrequently with topical corticosteroids, and they may occur more frequently with high potency corticosteroids, such as Ultravate Ointment. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.

Side Effects by Body System

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.

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