Betamethasone / clotrimazole topical Side Effects

Some side effects of betamethasone / clotrimazole topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to betamethasone / clotrimazole topical: topical cream, topical lotion

Get emergency medical help if you have any of these signs of an allergic reaction while taking betamethasone / clotrimazole topical: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these signs that you may be absorbing betamethasone topical through your skin or gums:

• swelling, redness, or any signs of new infection;

• severe burning or stinging of treated skin;

• weight gain, rounding of the face;

• increased thirst or hunger, urinating more than usual; or

• anxiety, depressed mood.

Less serious side effects of betamethasone / clotrimazole topical may include:

• mild skin itching or irritation;

• dry skin;

• changes in skin color;

• increased acne; or

• scarring or thinning of the skin.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to betamethasone / clotrimazole topical: topical cream, topical lotion

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 appears to be most susceptible to the adverse long-term effects of topical betamethasone. Use of high potency topical corticosteroids on these areas should be minimized or avoided.

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

Perioral dermatitis or rosacea-like dermatitis has occurred 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 resolves over a few weeks.

Worsening of psoriasis has occurred in a few patients.

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

Endocrine

Endocrinologic side effects have included suppression of the hypothalamic-pituitary-adrenal axis and has resulted in Cushing's Syndrome and symptoms of adrenal suppression following withdrawal of the drug. This has been more common when higher potency topical corticosteroids were used over extensive areas and when occlusive dressing were used.

Adrenal suppression has been reported in patients with psoriasis using betamethasone dipropionate. Plasma cortisol concentrations generally return to normal within one to two weeks following discontinuation of the drug, and in some cases returned to normal during continued therapy.

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

Ocular

Ocular side effects have included rare reports of glaucoma in patients who used betamethasone on the face for long periods of time. Intraocular pressure did not always return to normal following discontinuation of the drug.

Steroid-induced cataracts and glaucoma have been reported, most often in patients receiving betamethasone eyedrops (not available in the US). In one patient, permanent eye damage resulted from long-term application of betamethasone cream to the eyelids.

Musculoskeletal

Musculoskeletal side effect have included rare reports of osteoporosis in long-term betamethasone use. Vertebral fractures and avascular necrosis of the hips has been documented.

Dermatologic

Betamethasone-clotrimazole topical is not recommended for the treatment of diaper dermatitis. Adverse events consistent with corticosteroid use have been observed in patients treated for diaper dermatitis.

Dermatologic side effects have included rash, edema, dry skin, burning and stinging.

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