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.

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Clobex Side Effects - for the Professional

Clobex

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In controlled, clinical trials with Clobex® Spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with Clobex® Spray, 0.05% and 47% of subjects treated with Spray Vehicle]. Other commonly reported adverse reactions for Clobex® Spray, 0.05% and Spray Vehicle, respectively, are noted in Table 1.

Table 1 - Commonly Occurring Adverse Reactions (≥1% Incidence)

	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 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 changes	1 (1%)	0 (0%)
Application site pruritus	4 (3%)	3 (3%)
Infections and infestations	17 (14%)	12 (10%)
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%)

Most local adverse reactions were rated as mild to moderate and they are not affected by age, race or gender.

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

Postmarketing Experience

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.

The following adverse reactions have been identified during post-approval use of Clobex® Spray, 0.05%.

Skin: Burning, pruritus, erythema, pain, irritation, rash, peeling, urticaria, and contact dermatitis.

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Side Effects by Body System - for Healthcare Professionals

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.

Dermatologic

Dermatologic side effects have included postmarketing reports of erythema, pruritus, burning, alopecia, and dryness.

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