FDA label 58b3d93a-2c9f-4997-a5e9-663160d92fe4

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
a086ead1-b906-4198-af19-5423957c9e2a
SPL ID
58b3d93a-2c9f-4997-a5e9-663160d92fe4
Version
1
Effective date
2011-02-07
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:21:15

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 2 matching rows.

adverse reactions

ADVERSE REACTIONS In controlled clinical trials with CLOBEX ® (clobetasol propionate) Lotion, 0.05%, the following adverse reactions have been reported: burning/stinging, skin dryness, irritation, erythema, folliculitis, pruritus, skin atrophy, and telangiectasia. The pooled incidence of local adverse reactions in trials for psoriasis and atopic dermatitis with CLOBEX ® (clobetasol propionate) Lotion, 0.05% at 1.0% or greater was: Adverse Reaction Incidence Skin Atrophy 4.2% Telangiectasia 3.2% Discomfort Skin 1.3% Skin Dry 1.0% Other local adverse events occurred at rates less than 1.0%. Similar rates of local adverse reactions were reported in the comparator (clobetasol propionate cream, 0.05%). Most local adverse events were rated as mild to moderate and they are not affected by age, race or gender. The following additional local adverse reactions have been reported with topical corticosteroids. They may occur more frequently with the use of occlusive dressings and higher potency corticosteroids, including clobetasol propionate. These reactions are listed in an approximate decreasing order of occurrence: irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae and miliaria.

adverse reactions table

<table border="1" cellpadding="0" width="60%" ID="ifd9f295c-5fed-4aed-801b-46180e76a9ff"> <col width="50%"/> <col width="50%"/> <thead> <tr> <td> <content styleCode="bold"> Adverse Reaction</content> </td> <td> <content styleCode="bold">Incidence</content> </td> </tr> </thead> <tbody> <tr> <td> <content styleCode="bold"> </content> Skin Atrophy</td> <td>4.2%</td> </tr> <tr> <td> <content styleCode="bold"> </content> Telangiectasia</td> <td>3.2%</td> </tr> <tr> <td> <content styleCode="bold"> </content> Discomfort Skin</td> <td>1.3%</td> </tr> <tr> <td> <content styleCode="bold"> </content> Skin Dry</td> <td>1.0%</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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