Cutivate Cream Side Effects
Please note - some side effects for Cutivate Cream may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Cutivate Cream Side Effects - for the Professional
Cutivate Cream
Clinical Trial Experience: 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.
| 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 |
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*See text for additional detail. |
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† n = 41. |
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| 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%) |
Post Marketing Experience: Systemic adverse events with CUTIVATE® Cream and CUTIVATE® 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® 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.
TopSide Effects by Body System - for Healthcare Professionals
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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