VANOS SIDE EFFECTS
- Generic Name: fluocinonide
- Brand Name: Vanos
- Drug Class: Corticosteroids, Topical
SIDE EFFECTS
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 (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.
Postmarking 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.
SRC: NLM .