Vanos Side Effects

Please note - some side effects for Vanos 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 Vanos - for the Consumer

Vanos Cream

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 Vanos Cream:

Burning, itching, irritation, dryness, redness at the treatment site; change in skin color; headache; stuffy nose.

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue); deterioration of the skin; increased hunger, urination, or thirst; signs of skin infection, such as severe or persistent redness, swelling, or itching; tiredness; weakness; wheezing.

Vanos Side Effects - for the Professional

Vanos

In clinical trials, a total of 443 adult patients with atopic dermatitis or plaque-type psoriasis were treated once daily or twice daily with Vanos™ Cream for 2 weeks. The most commonly observed adverse events in these clinical trials were as follows:

No other adverse events were reported by more than 1 subject receiving active treatment. The incidence of all adverse events was similar between the active treatment groups and the vehicle control groups. Safety in patients 12 to 17 years of age was similar to that observed in adults.

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

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

Side Effects by Body System

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 fluocinonide. Use of high potency topical corticosteroids on these areas should be minimized or avoided.

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

Perioral dermatitis or rosacea-like dermatitis has occurred in 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 when applied to denuded skin. Long-term use of topical corticosteroids has resulted in skin atrophy and thinning, and the development of striae, telangiectasia, subcutaneous hemorrhage, easy bruising, and bleeding. Allergic contact dermatitis has been occasionally reported.

Endocrine

Endocrine side effects have included rare reports of hypothalamic-pituitary-adrenal (HPA) axis suppression. These reports were generally cases when higher potency topical corticosteroids were used over extensive areas and when occlusive dressings were used. HPA axis suppression has not been reported with fluocinonide.

In one study, six patients received fluocinonide cream applied to 75% of their body (approximately 14 grams) every day for six days. No indication of HPA axis suppression was seen when compared with placebo.

Nervous system

Nervous system side effects have included headache.

Respiratory

Respiratory system side effects have included nasopharyngitis and nasal congestion.

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