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Clobetasol (Clobetasol Propionate Topical) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

In a controlled pharmacokinetic study, 5 of 13 subjects experienced reversible suppression of the adrenals at any time during the 14 days of clobetasol propionate foam, 0.05% therapy to at least 20% of the body surface area. Of the 13 subjects studied, 1 of 9 with psoriasis were suppressed after 14 days and all 4 of the subjects with atopic dermatitis had abnormal cortisol levels indicative of adrenal suppression at some time after starting therapy with clobetasol propionate foam, 0.05%. See Table 3 below.

Table 3: Subjects with reversible HPA axis suppression at any time during treatment
Dermatosis Clobetasol Propionate Foam, 0.05%
Psoriasis 1 of 9
Atopic Dermatitis 4 of 4

Systemic absorption of topical corticosteroids has produced reversible adrenal suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. See PRECAUTIONS

In a controlled clinical trial (188 subjects) with clobetasol propionate foam, 0.05% in subjects with psoriasis of the scalp, there were no localized scalp adverse reactions reported in the clobetasol propionate foam, 0.05% treated subjects. In two controlled clinical trials (360 subjects) with clobetasol propionate foam, 0.05% in subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the clobetasol propionate foam, 0.05% treated subjects included application site burning (10%), application site dryness (<1%), and other application site reactions (4%).

In larger controlled trials with other clobetasol propionate formulations, the most frequently reported local adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, skin atrophy, and telangiectasia (all less than 2%).

The following additional local adverse reactions have been reported with topical corticosteroids, but they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids such as clobetasol propionate foam, 0.05%. These reactions are listed in an approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, and miliaria.



REPORTS OF SUSPECTED CLOBETASOL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Clobetasol. The information is not vetted and should not be considered as verified clinical evidence.

Possible Clobetasol side effects / adverse reactions in 82 year old male

Reported by a physician from France on 2011-12-13

Patient: 82 year old male

Reactions: Osteopenia, Skin Atrophy

Suspect drug(s):
Clobetasol

Other drugs received by patient: Prednisolone



See index of all Clobetasol side effect reports >>

Drug label data at the top of this Page last updated: 2011-07-19

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