Home FDA labels 635b46a1-04a0-40d5-a20d-cc9170eb9a85 FDA label 635b46a1-04a0-40d5-a20d-cc9170eb9a85 openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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SPL set ID 1faf8d75-af60-4438-b6d5-c1b06d5ac703
SPL ID 635b46a1-04a0-40d5-a20d-cc9170eb9a85
Version 3
Effective date 2017-03-30
Source export date 2026-10-12
Source partition 8
Source file https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
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adverse reactions ADVERSE REACTIONS The most frequent adverse event was burning/itching/stinging at the application site; the incidence and severity of this event were as follows: Incidence and severity of burning/itching/stinging Maximum severity Product Total incidence Mild Moderate Severe Betamethasone valerate foam n = 63 34 (54%) 28 (44%) 5 (8%) 1 (2%) Betamethasone valerate lotion n = 63 33 (52%) 26 (41%) 6 (10%) 1 (2%) Placebo Foam n = 32 24 (75%) 13 (41%) 7 (22%) 4 (12%) Placebo Lotion n = 30 20 (67%) 12 (40%) 5 (17%) 3 (10%) Other adverse events which were considered to be possibly, probably, or definitely related to betamethasone valerate foam occurred in 1 patient each; these were paresthesia, pruritus, acne, alopecia, and conjunctivitis. The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximately decreasing order of occurrence: irritation; dryness; folliculitis; acneiform eruptions; hypopigmentation; perioral dermatitis; allergic contact dermatitis; secondary infection; skin atrophy; striae; and miliaria. Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.
adverse reactions table <table width="100%"><col width="45%"/><col width="19%"/><col width="12%"/><col width="12%"/><col width="11%"/><tbody><tr><td colspan="5" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>Incidence and severity of burning/itching/stinging</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph> </paragraph></td><td styleCode="Rrule Lrule Botrule " valign="top"/><td align="center" colspan="3" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Maximum severity</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Product</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Total incidence</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Mild</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Moderate</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Severe</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Betamethasone valerate foam n = 63</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>34 (54%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>28 (44%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>5 (8%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1 (2%)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Betamethasone valerate lotion n = 63</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>33 (52%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>26 (41%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>6 (10%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>1 (2%)</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Placebo Foam n = 32</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>24 (75%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>13 (41%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>7 (22%)</paragraph></td><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph>4 (12%)</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Placebo Lotion n = 30</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>20 (67%)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>12 (40%)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>5 (17%)</paragraph></td><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph>3 (10%)</paragraph></td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.