Cutivate Side Effects

Generic name: fluticasone topical

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

Some side effects of Cutivate 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 fluticasone topical: topical cream, topical lotion, topical ointment

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

Although the risk of serious side effects is low when fluticasone topical is applied to the skin, side effects can occur if the medication is absorbed into your bloodstream.

Stop using this medicine and call your doctor at once if you have signs of absorbing fluticasone topical through your skin, such as:

• blurred vision, or seeing halos around lights;

• headache, back ache, weakness, confusion, mood changes;

• sleep problems (insomnia);

• weight gain, puffiness in your face;

• muscle weakness, feeling tired; or

• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

Less serious side effects of fluticasone topical may include:

• mild skin itching, burning, peeling, or dryness;

• changes in color of treated skin;

• thinning or softening of your skin;

• skin rash or irritation around your mouth;

• redness or crusting around your hair follicles;

• 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 fluticasone topical: topical cream, topical lotion, 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, 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 site of application. Postmarketing experience has included reports of erythema, edema/swelling, bleeding, and a lack of efficacy.

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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