Cutivate Side Effects

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

Cutivate 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 Cutivate 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 Cutivate Cream; excessive hair growth; inflamed hair follicles; inflammation around the mouth; thinning, softening, or discoloration of the skin.

Cutivate Lotion

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 Cutivate Lotion:

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 Cutivate Lotion; excessive hair growth; inflamed hair follicles; inflammation around the mouth; thinning, softening, or discoloration of the skin.

Cutivate Side Effects - for the Professional

Cutivate

In controlled clinical trials, the total incidence of adverse reactions associated with the use of Cutivate® Ointment was approximately 4%. These adverse reactions were usually mild, self-limiting, and consisted primarily of pruritus, burning, hypertrichosis, increased erythema, hives, irritation, and lightheadedness. Each of these events occurred individually in less than 1% of patients.

In a study of 35 pediatric patients treated with fluticasone propionate ointment, 0.005% for atopic dermatitis over at least 35% of body surface area, subnormal adrenal function was observed with cosyntropin stimulation testing at the end of 3 to 4 weeks of treatment in 4 patients who had normal testing prior to treatment. It is not known if these patients had recovery of adrenal function because follow-up testing was not performed. Telangiectasia on the face was noted in 1 patient on the eighth day of a 4-week treatment period. Facial use was discontinued and the telangiectasia resolved.

The following additional local adverse reactions have been reported infrequently with topical corticosteroids, including fluticasone propionate, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. Also, there are reports of the development of pustular psoriasis from chronic plaque psoriasis following reduction or discontinuation of potent topical corticosteroid products.

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, axilla, and groin are most susceptible to the adverse long-term effects of topical corticosteroids. Use of high potency topical corticosteroids on these areas should be minimized or avoided.

Topical corticosteroid use may suppress local immune responses, rendering the skin more susceptible to infections. Folliculitis has occasionally been 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 resolve over a few weeks.

Worsening of psoriasis has occurred in a few patients.

Local adverse effects have included burning, itching, dryness, redness, or irritation, especially if applied to denuded skin. Also, acneiform eruptions, folliculitis, hypopigmentation, blisters, hypertrichosis, and infection have been reported. Long-term use of topical corticosteroids may result in skin atrophy and thinning, and the development of striae, telangiectasia, subcutaneous hemorrhage, and easy bruising and bleeding. Allergic contact dermatitis has been reported.

Endocrine

Endocrine side effects have rarely included symptoms of hypothalamic-pituitary-adrenal (HPA) axis suppression. These effects are more likely when higher potency topical corticosteroids are used over extensive areas and when occlusive dressings are used. HPA axis suppression has been reported with topical fluticasone when used at doses of 30 grams per day on patients with diseased skin.

Nervous system

Nervous system side effects have included lightheadedness in less than 1% of patients treated.

Dermatologic

Dermatologic side effects have included burning and pruritus at the side of application.

In a controlled study, the incidence of burning and pruritus occurred in 6% of both fluticasone-treated patients and those who received vehicle only.

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