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Cutivate

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Cutivate Cream

Cutivate Cream

Cutivate Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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

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

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cutivate in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cutivate (Fluticasone Propionate Cream) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cutivate FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trial Experience

In controlled clinical trials of twice-daily administration, the total incidence of adverse reactions associated with the use of CUTIVATE® (fluticasone propionate cream) 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® (fluticasone propionate cream) 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® (fluticasone propionate cream) 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® (fluticasone propionate cream) Cream; and telangiectasia, resolving within 3 months after stopping CUTIVATE® (fluticasone propionate cream) 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 4 (1.9%) 1 (0.5%) 1 (1.3%)
eczema      
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 = 41.

Post Marketing Experience

Systemic adverse events with CUTIVATE® (fluticasone propionate cream) Cream and CUTIVATE® (fluticasone propionate cream) Ointment have included: immunosuppression/Pneumocystis carinii pneumonia/leukopenia/thrombocytopenia; hyperglycemia/ glycosuria; Cushing syndrome; generalized body edema/blurred vision; and acute urticarial reaction (edema, urticaria, pruritus, and throat swelling).

The following localized adverse reactions have been reported during post approval use of CUTIVATE® (fluticasone propionate cream) Cream: skin discoloration, erythema, irritation, edema/swelling, atrophy, contusion, dermatitis, pain, sepsis, hemorrhage, acneiform eruptions.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Cutivate (Fluticasone Propionate Cream) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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