FDA label 658613fc-a080-468d-b588-ce32ece3171b

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SPL set ID
34b91547-31f6-4043-b91c-16c9ebd81349
SPL ID
658613fc-a080-468d-b588-ce32ece3171b
Version
1
Effective date
2010-02-04
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:16:56

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS 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.

adverse reactions table

<table width="100%" ID="i4d01cc05-dd87-4c1f-8e4d-e25a18d9c39a"> <caption>Table 3: Most Commonly Observed Adverse Events in Adult Clinical Trials</caption> <col align="left" width="37%" valign="top"/> <col align="center" width="20%" valign="top"/> <col align="center" width="20%" valign="top"/> <col align="center" width="23%" valign="top"/> <thead> <tr> <th styleCode="Lrule">Adverse Event</th> <th styleCode="Lrule">VANOS Cream, <content styleCode="italics">once daily</content> (n=216)</th> <th styleCode="Lrule">VANOS Cream, <content styleCode="italics">twice daily</content> (n=227)</th> <th styleCode="Lrule Rrule">Vehicle Cream, <content styleCode="italics">once</content> or <content styleCode="italics">twice daily</content> (n=211)</th> </tr> </thead> <tbody> <tr styleCode="Botrule"> <td styleCode="Lrule">Headache</td> <td styleCode="Lrule">8/216 (3.7%)</td> <td styleCode="Lrule">9/227 (4.0%)</td> <td styleCode="Lrule Rrule">6/211 (2.8%)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule">Application Site Burning</td> <td styleCode="Lrule">5/216 (2.3%)</td> <td styleCode="Lrule">4/227 (1.8%)</td> <td styleCode="Lrule Rrule">14/211 (6.6%)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule">Nasopharyngitis</td> <td styleCode="Lrule">2/216 (0.9%)</td> <td styleCode="Lrule">3/227 (1.3%)</td> <td styleCode="Lrule Rrule">3/211 (1.4%)</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule">Nasal Congestion</td> <td styleCode="Lrule">3/216 (1.4%)</td> <td styleCode="Lrule">1/227 (0.4%)</td> <td styleCode="Lrule Rrule">0</td> </tr> <tr> <td styleCode="Lrule">Unspecified Application Site Reaction</td> <td styleCode="Lrule">1/216 (0.4%)</td> <td styleCode="Lrule">1/227 (0.4%)</td> <td styleCode="Lrule Rrule">3/211 (1.4%)</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.