VANOS SIDE EFFECTS
- Generic Name: fluocinonide
- Brand Name: Vanos
- Drug Class: Corticosteroids, Topical
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:
Table 1: Most Commonly Observed Adverse Reactions ( ≥ 1%) in Adult Clinical Trials
|Adverse Reaction||VANOS Cream, once daily
|VANOS Cream, twice daily
|Vehicle Cream, once or twice daily
|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.
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.
SRC: NLM .