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.
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:
Seek medical attention right away if any of these SEVERE side effects occur when using Vanos Cream:Burning, itching, irritation, dryness, or redness at the treatment site; headache.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; dizziness; excessive hair growth; fainting; inflamed hair follicles; inflammation around the mouth; irritation, burning, redness, or swelling not present before using Vanos Cream; loss of appetite; nausea or vomiting; thinning, softening, or discoloration of the skin; unexplained weight loss; unusual tiredness; weakness.
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.
TopVanos Side Effects - for the Professional
Vanos
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In clinical trials, a total of 443 adult subjects 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 reactions in these clinical trials were as follows:
| Adverse Reaction | Vanos Cream, once daily (n=216) |
Vanos Cream, twice daily (n=227) |
Vehicle Cream, once or twice daily (n=211) |
|---|---|---|---|
| Headache | 8 (3.7%) | 9 (4.0%) | 6 (2.8%) |
| Application Site Burning | 5 (2.3%) | 4 (1.8%) | 14 (6.6%) |
| Nasopharyngitis | 2 (0.9%) | 3 (1.3%) | 3 (1.4%) |
| Nasal Congestion | 3 (1.4%) | 1 (0.4%) | 0 |
Safety in patients 12 to 17 years of age was similar to that observed in adults.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of Vanos Cream:
Administration Site Conditions: discoloration, erythema, irritation, pruritus, swelling, pain and condition aggravated.
Immune System Disorders: hypersensitivity.
Nervous System Disorders: headache and dizziness.
Skin and Subcutaneous Tissue Disorders: acne, dry skin, rash, skin exfoliation and skin tightness.
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.
TopSide Effects by Body System - for Healthcare Professionals
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.
TopMore Vanos resources
- Vanos Prescribing Information (FDA)
- Vanos Advanced Consumer (Micromedex) - Includes Dosage Information
- Vanos Concise Consumer Information (Cerner Multum)
- Vanos Cream MedFacts Consumer Leaflet (Wolters Kluwer)
- Lidex Cream MedFacts Consumer Leaflet (Wolters Kluwer)
- Lidex Prescribing Information (FDA)
- Lidex Topical Solution Prescribing Information (FDA)
- Lidex-E Prescribing Information (FDA)
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