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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).


For the consumer

For the professional

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.

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

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.

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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:

Table 3: Most Commonly Observed Adverse Events in Adult Clinical Trials
Adverse Event Vanos™ Cream,
once daily
(n=216)
Vanos™ Cream,
twice daily
(n=227)
Vehicle Cream,
once or twice daily
(n=211)
Headache 8/216 (3.7%) 9/227 (4.0%) 6/211 (2.8%)
Application Site Burning 5/216 (2.3%) 4/227 (1.8%) 14/211 (6.6%)
Nasopharyngitis 2/216 (0.9%) 3/227 (1.3%) 3/211 (1.4%)
Nasal Congestion 3/216 (1.4%) 1/227 (0.4%) 0
Unspecified Application Site Reaction 1/216 (0.4%) 1/227 (0.4%) 3/211 (1.4%)

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.

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