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

Applies to fluticasone topical: topical application cream, topical application lotion, topical application ointment.

Serious side effects of Cutivate

Along with its needed effects, fluticasone topical (the active ingredient contained in Cutivate) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fluticasone topical:

Less common

• Burning, itching, redness, or stinging of the skin
• hives or welts, skin rash
• raised, dark red, wart-like spots on the skin, especially when used on the face

Rare

• Burning, itching, and pain in hairy areas, pus at the root of the hair

Incidence not known

• Backache
• black, tarry stools
• bleeding gums
• blindness
• blistering, burning, crusting, dryness, or flaking of the skin
• blood in the urine or stools
• blurred vision
• burning and itching of skin with pinhead-sized red blisters
• change in vision
• chest pain
• darkening of the skin
• decreased vision
• diarrhea
• dizziness
• dry mouth
• eye pain
• facial hair growth in females
• fainting
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• headache
• increased hunger or thirst
• increased urination
• irritability
• itching, scaling, severe redness, soreness, swelling of the skin
• lightening of the normal skin color
• lightening of treated areas of the dark skin
• loss of appetite
• loss of sexual desire or ability
• loss of vision
• menstrual irregularities
• mental depression
• muscle wasting
• nausea
• painful or difficult urination
• pinpoint red spots on the skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• redness and scaling around the mouth
• stomach pain
• sweating
• tearing
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)
• unexplained weight loss
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Other side effects of Cutivate

Some side effects of fluticasone topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Body aches or pain
• change in hearing
• chills
• common cold
• cough
• difficulty with breathing
• dry skin
• ear congestion
• ear drainage
• earache or pain in the ear
• fever
• increased hair growth on the forehead, back, arms, and legs
• lightheadedness
• loss of voice
• runny or stuffy nose
• sneezing
• sore throat

For Healthcare Professionals

Applies to fluticasone topical: topical cream, topical kit, topical lotion, topical ointment.

Local

Common (1% to 10 %): Erythema, burning, stinging^[Ref]

Endocrine

Very rare (less than 0.01%): Hypothalamic-pituitary-adrenal (HPA) axis suppression, Increased weight, obesity, delayed weight gain, growth retardation in children, cushingoid features (e.g. moon face, central obesity), decreased endogenous cortisol levels^[Ref]

Nervous system

Frequency not reported: Intracranial hypertension (including bulging fontanelles, headaches, bilateral papilledema)^[Ref]

Dermatologic

Common (1% to 10%): Erythematous rash, facial telangiectasia, non-facial telangiectasia, urticaria, pruritus

Uncommon (0.1% to 1%): Skin infection, infected eczema, impetigo, atopic dermatitis, eczema, skin irritation, folliculitis, blisters, dryness of skin, local skin burning

Frequency not reported: Irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, hypertrichosis, miliaria, pustular psoriasis^[Ref]

Cardiovascular

Very rare (less than 0.01%): Hypertension^[Ref]

Musculoskeletal

Very rare (less than 0.01%): Osteoporosis^[Ref]

Ocular

Very rare (less than 0.01%): Cataract, glaucoma^[Ref]

Immunologic

Uncommon (0.1% to 1%): Viral warts, herpes simplex

Very rare (less than 0.01%): Opportunistic infections^[Ref]

Hypersensitivity

Very rare (less than 0.01%): Hypersensitivity^[Ref]

General

The most commonly reported side effects were erythema, burning, and stinging.^[Ref]