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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:
Immune System Disorders: hypersensitivity.
Nervous System Disorders: headache and dizziness.
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.
Last reviewed on RxList: 4/4/2012
This monograph has been modified to include the generic and brand name in many instances.
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