Cutivate Side Effects Center

Last updated on RxList: 9/29/2020
Cutivate Side Effects Center

What Is Cutivate?

Cutivate (fluticasone propionate cream) is a topical (for the skin) steroid used to treat inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis. Cutivate is not used to treat rosacea, severe acne, or viral skin infections such as chickenpox or herpes. Some forms and strengths of Cutivate are available in generic form.

What Are Side Effects of Cutivate?

Common side effects of Cutivate include:

  • mild skin itching,
  • burning,
  • peeling,
  • dryness,
  • changes in color of treated skin,
  • headache,
  • thinning or softening of skin,
  • skin rash or irritation around the mouth,
  • swollen hair follicles,
  • redness or crusting around hair follicles,
  • blisters,
  • pimples,
  • crusting of treated skin, or
  • stretch marks.

Dosage for Cutivate?

Dosage: Apply a thin film of Cutivate Cream to the affected skin areas once or twice daily, according to doctor's instructions. Do not give to children under 12 years of age unless advised by a physician.

What Drugs, Substances, or Supplements Interact with Cutivate?

It is unlikely other drugs taken orally or injected will have an effect on topically applied Cutivate Cream.

Cutivate During Pregnancy and Breastfeeding

Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Cutivate is not recommended for use during pregnancy, as it may be harmful to a fetus. It is not known whether fluticasone topical passes into breast milk or if it could harm a nursing baby. Consult your doctor if you are breastfeeding.

Additional Information

Our Cutivate (fluticasone propionate cream) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Psoriasis causes the top layer of skin cells to become inflamed and grow too quickly and flake off. See Answer
Cutivate Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • skin pain, tenderness, or swelling;
  • any wound that will not heal;
  • blurred vision, eye pain;
  • severe skin irritation after using the medicine; or
  • possible signs of absorbing this medicine through your skin--weight gain (especially in your face or your upper back and torso), thinning or discolored skin, increased body hair, muscle weakness, nausea, diarrhea, tiredness, mood changes, menstrual changes, sexual changes.

Common side effects may include:

  • skin redness, itching, or rash;
  • burning or stinging of treated skin;
  • increased hair growth; or
  • feeling light-headed.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Types of Psoriasis: Medical Pictures and Treatments See Slideshow
Cutivate Professional Information


In controlled clinical trials of twice-daily administration, the total incidence of adverse reactions associated with the use of CUTIVATE® Cream was approximately 4%. These adverse reactions were usually mild; self-limiting; and consisted primarily of pruritus, dryness, numbness of fingers, and burning. These events occurred in 2.9%, 1.2%, 1.0%, and 0.6% of patients, respectively.

Two clinical studies compared once- to twice-daily administration of CUTIVATE® Cream for the treatment of moderate to severe eczema. The local drug-related adverse events for the 491 patients enrolled in both studies are shown in Table 1. In the study enrolling both adult and pediatric patients, the incidence of local adverse events in the 119 pediatric patients ages 1 to 12 years was comparable to the 140 patients ages 13 to 62 years.

Fifty-one pediatric patients ages 3 months to 5 years, with moderate to severe eczema, were enrolled in an open-label HPA axis safety study. CUTIVATE® Cream was applied twice daily for 3 to 4 weeks over an arithmetic mean body surface area of 64% (range, 35% to 95%). The mean morning cortisol levels with standard deviations before treatment (prestimulation mean value = 13.76 ± 6.94 mcg/dL, poststimulation mean value = 30.53 ± 7.23 mcg/dL) and at end treatment (prestimulation mean value = 12.32 ± 6.92 mcg/dL, poststimulation mean value = 28.84 ± 7.16 mcg/dL) showed little change. In 2 of 43 (4.7%) patients with end-treatment results, peak cortisol levels following cosyntropin stimulation testing were ≤ 18 μg/dL, indicating adrenal suppression. Follow-up testing after treatment discontinuation, available for 1 of the 2 subjects, demonstrated a normally responsive HPA axis. Local drug-related adverse events were transient burning, resolving the same day it was reported; transient urticaria, resolving the same day it was reported; erythematous rash; dusky erythema, resolving within 1 month after cessation of CUTIVATE® Cream; and telangiectasia, resolving within 3 months after stopping CUTIVATE® Cream.

Table 1: Drug-Related Adverse Events—Skin

Adverse Events Fluticasone Once Daily (n=210) Fluticasone Twice Daily (n = 203) Vehicle Twice Daily (n = 78)
Skin infection 1 (0.5%) 0 0
Infected eczema 1 (0.5%) 2 (1.0%) 0
Viral warts 0 1 (0.5%) 0
Herpes simplex 0 1 (0.5%) 0
Impetigo 1 (0.5%) 0 0
Atopic dermatitis 1 (0.5%) 0 0
Eczema 1 (0.5%) 0 0
Exacerbation of eczema 4 (1.9%) 1 (0.5%) 1 (1.3%)
Erythema 0 2 (1.0%) 0
Burning 2 (1.0%) 2 (1.0%) 2 (2.6%)
Stinging 0 2 (1.0%) 1 (1.3%)
Skin irritation 6 (2.9%) 2 (1.0%) 0
Pruritus 2 (1.0%) 4 (1.9%) 4 (5.1%)
Exacerbation of pruritus 4 (1.9%) 1 (0.5%) 1 (1.3%)
Folliculitis 1 (0.5%) 1 (0.5%) 0
Blisters 0 1 (0.5%) 0
Dryness of skin 3 (1.4%) 1 (0.5%) 0

Table 2: Adverse Events * From Pediatric Open-Label Trial (n = 51)

Adverse Events Fluticasone Twice Daily
Burning 1 (2.0%)
Dusky erythema 1 (2.0%)
Erythematous rash 1 (2.0%)
Facial telangiectasia† 2 (4.9%)
Non-facial telangiectasia 1 (2.0%)
Urticaria 1 (2.0%)
*See text for additional detail.
†n = 4 1.

The following local adverse reactions have been reported infrequently with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreas ing order of occurrence: irritation, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, hypertrichosis 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.

Read the entire FDA prescribing information for Cutivate (Fluticasone Topical)

© Cutivate Patient Information is supplied by Cerner Multum, Inc. and Cutivate Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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