ADVERSE REACTIONS
In controlled clinical trials, the total incidence of adverse reactions associated with the use of CUTIVATE® Ointment was approximately 4%. These adverse reactions were usually mild, self-limiting, and consisted primarily of pruritus, burning, hypertrichosis, increased erythema, hives, irritation, and lightheadedness. Each of these events occurred individually in less than 1% of patients.
In a study of 35 pediatric patients treated with fluticasone propionate ointment, 0.005% for atopic dermatitis over at least 35% of body surface area, subnormal adrenal function was observed with cosyntropin stimulation testing at the end of 3 to 4 weeks of treatment in 4 patients who had normal testing prior to treatment. It is not known if these patients had recovery of adrenal function because follow-up testing was not performed (see PRECAUTIONS: Laboratory Tests and PRECAUTIONS: Pediatric Use). Telangiectasia on the face was noted in 1 patient on the eighth day of a 4-week treatment period. Facial use was discontinued and the telangiectasia resolved.
The following additional local adverse reactions have been reported infrequently with topical corticosteroids, including fluticasone propionate, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, 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.
|
REPORTS OF SUSPECTED CUTIVATE SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Cutivate. The information is not vetted and should not be considered as verified clinical evidence.
Possible Cutivate side effects / adverse reactions in 43 year old female
Reported by a physician from Russian Federation on 2012-06-14
Patient: 43 year old female
Reactions: Burning Sensation, Application Site Erosion, Blister
Adverse event resulted in: hospitalization
Suspect drug(s):
Ketoprofen
Administration route: Topical
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-19
End date: 2012-05-20
Cutivate
Administration route: Topical
Indication: Dermatitis Allergic
Start date: 2012-05-21
End date: 2012-05-21
|
