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Side Effects > Clobex

Clobex Side Effects

Please note - some side effects for Clobex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).


Side Effects of Clobex - for the Consumer

Clobex Lotion

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Clobex Lotion:

Dryness; itching; mild burning or stinging.

Seek medical attention right away if any of these SEVERE side effects occur when using Clobex Lotion:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Clobex Lotion; dark red blotches on the skin; excessive hair growth; general feeling of being unwell; inflamed hair follicles; inflammation around the mouth; muscle weakness; numbness of fingers; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

Clobex Shampoo

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Clobex Shampoo:

Acne; blisters on the scalp; burning/stinging sensation; dry skin; itching; swelling of the follicles; tingling.

Seek medical attention right away if any of these SEVERE side effects occur when using Clobex Shampoo:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dizziness; increased thirst or urination; nausea; ongoing headache; unusual weakness or weight loss; vision problems; vomiting.

Clobex Spray

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Clobex Spray:

Dryness; itching; mild burning or stinging.

Seek medical attention right away if any of these SEVERE side effects occur when using Clobex Spray:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, or peeling not present before you began using Clobex Spray; dark red blotches on the skin; excessive hair growth; general feeling of being unwell; inflamed hair follicles; inflammation around the mouth; muscle weakness; numbness of fingers; persistent sore throat, cough, or congestion; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

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Clobex Side Effects - for the Professional

Clobex

In controlled, clinical trials with Clobex® (clobetasol propionate) Spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with Clobex® (clobetasol propionate) Spray, 0.05% and 47% of subjects treated with Spray Vehicle]. Other commonly reported adverse reactions for Clobex® (clobetasol propionate) Spray, 0.05% and Spray Vehicle, respectively, are noted in Table 2.

Table 2 - Commonly Occurring Adverse Events
Clobetasol Propionate Vehicle Spray
Adverse Reaction 0.05% Spray (N=120)
(N=120)
System Organ Class
General disorders and administration site conditions 50 (42%) 56 (47%)
Application site atrophy 0 (0%) 1 (1%)
Application site burning 48 (40%) 56 (47%)
Application site dryness 2 (2%) 0 (0%)
Application site irritation 1 (1%) 0 (0%)
Application site pain 1 (1%) 2 (2%)
Application site pigmentation change 1 (1%) 0 (0%)
Application site pruritus 4 (3%) 3 (3%)
Infections and Infestations 17 (14%) 12 (10%)
Influenza 0 (0%) 2 (2%)
Nasopharyngitis 6 (5%) 3 (3%)
Pharyngitis streptococcal 1 (1%) 0 (0%)
Upper respiratory tract infection 10 (8%) 2 (2%)
Skin and subcutaneous tissue disorders 4 (3%) 2 (2%)
Eczema asteatotic 2 (2%) 0 (0%)

Other adverse events occurred at rates less than 1.0%. Most local adverse events were rated as mild to moderate and they are not affected by age, race or gender. The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.

Systemic absorbtion of topical corticosteroids has produced hypothalamic-pituitary-adrenal (HPA) axis suppression manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

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Side Effects by Body System

Local

Local side effects have commonly included burning, itching, dryness, or irritation, especially if applied to denuded skin. Long-term use of topical corticosteroids has resulted in skin atrophy and thinning, and the development of striae, telangiectasias, subcutaneous hemorrhage, and easy bruising and bleeding. Allergic contact dermatitis has been occasionally reported.

Skin atrophy may become evident within one to two months of use. Atrophy is due to the inhibitory effect of corticosteroids on collagen formulation. Skin on the face, axilla, and groin appears to be most susceptible to the adverse long-term effects of topical clobetasol. Use of high potency topical corticosteroids on these areas should be minimized or avoided.

Topical corticosteroid use may impair the local immune response, rendering skin more susceptible to infection. Folliculitis is occasionally reported.

Perioral dermatitis or rosacea-like dermatitis has occurred in patients with seborrheic skin types who were treated with potent topical corticosteroids. 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 resolves over a few weeks.

Worsening of psoriasis has occurred in a few patients.

Endocrine

Endocrinologic side effects have included suppression of the hypothalamic-pituitary-adrenal (HPA) axis. Withdrawal of therapy has resulted in the development of cushingoid features and symptoms of adrenal suppression. This was more likely when higher potency topical corticosteroids were used over extensive areas and when occlusive dressings were used. In addition, the gel and emollient cream formulation of clobetasol provided better penetration, and thus, higher risk of adrenal suppression.

Adrenal suppression has been reported in patients with psoriasis using doses of less than 50 grams per week, although this dosage is generally considered to be safe. Adrenal suppression has been reported in at least one patient receiving 7.5 grams per week. Plasma cortisol concentrations generally return to normal within one to two weeks following discontinuation of the drug. In a few cases adrenal failure persisted up to four months.

If clobetasol is to be used for an extended period of time, adrenal function should be evaluated periodically. Supplemental systemic steroids may be necessary during times of stress.

Ocular

Ocular side effects have rarely included glaucoma in patients using clobetasol on the face for long periods of time. Intraocular pressure did not always return to normal following discontinuation of the drug.

Musculoskeletal

Musculoskeletal side effects have included rare reports of osteoporosis with long term use. Vertebral fractures and avascular necrosis of the hips have been documented.

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