FDA label fbf1ab44-6114-49ef-9223-4fd6bcf832eb

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SPL set ID
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SPL ID
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Version
2
Effective date
2010-12-28
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
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Source manifest SHA-256
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Import run
20261013T011858Z
Imported at
2026-10-13 01:30:07

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS In controlled, clinical trials with CLOBEX ® (clobetasol propionate) Spray, 0.05%, the most common adverse reaction was burning at the site of application [40% of subjects treated with CLOBEX ® (clobetasol propionate) Spray, 0.05% and 47% of subjects treated with Spray Vehicle]. Other commonly reported adverse reactions for CLOBEX ® (clobetasol propionate) Spray, 0.05% and Spray Vehicle, respectively, are noted in Table 2. Table 2 - Commonly Occurring Adverse Events Clobetasol Propionate Vehicle Spray Adverse Reaction 0.05% Spray (N=120) (N=120) System Organ Class General disorders and administration site conditions 50 (42%) 56 (47%) Application site atrophy 0 (0%) 1 (1%) Application site burning 48 (40%) 56 (47%) Application site dryness 2 (2%) 0 (0%) Application site irritation 1 (1%) 0 (0%) Application site pain 1 (1%) 2 (2%) Application site pigmentation changes 1 (1%) 0 (0%) Application site pruritus 4 (3%) 3 (3%) Infections and infestations 17 (14%) 12 (10%) Influenza 0 (0%) 2 (2%) Nasopharyngitis 6 (5%) 3 (3%) Pharyngitis streptococcal 1 (1%) 0 (0%) Upper respiratory tract infection 10 (8%) 2 (2%) Skin and subcutaneous tissue disorders 4 (3%) 2 (2%) Eczema asteatotic 2 (2%) 0 (0%) Other adverse events occurred at rates less than 1.0%. 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: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, 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 ID="i50f1962c-907a-47bd-8d51-dd04002ffa28"> <caption>Table 2 - Commonly Occurring Adverse Events</caption> <thead> <tr> <td> </td> <td>Clobetasol Propionate</td> <td>Vehicle Spray</td> </tr> <tr> <td> <content styleCode="bold"> <content styleCode="underline">Adverse Reaction</content> </content> </td> <td>0.05% Spray</td> <td>(N=120)</td> </tr> <tr> <td> </td> <td>(N=120)</td> <td> </td> </tr> </thead> <tbody> <tr> <td>System Organ Class</td> <td> </td> <td> </td> </tr> <tr> <td>General disorders and administration site conditions</td> <td>50 (42%)</td> <td>56 (47%)</td> </tr> <tr> <td> Application site atrophy</td> <td>0 (0%)</td> <td>1 (1%)</td> </tr> <tr> <td> Application site burning</td> <td>48 (40%)</td> <td>56 (47%)</td> </tr> <tr> <td> Application site dryness</td> <td>2 (2%)</td> <td>0 (0%)</td> </tr> <tr> <td> Application site irritation</td> <td>1 (1%)</td> <td>0 (0%)</td> </tr> <tr> <td> Application site pain</td> <td>1 (1%)</td> <td>2 (2%)</td> </tr> <tr> <td> Application site pigmentation changes</td> <td>1 (1%)</td> <td>0 (0%)</td> </tr> <tr> <td> Application site pruritus</td> <td>4 (3%)</td> <td>3 (3%)</td> </tr> <tr> <td>Infections and infestations</td> <td>17 (14%)</td> <td>12 (10%)</td> </tr> <tr> <td> Influenza</td> <td>0 (0%)</td> <td>2 (2%)</td> </tr> <tr> <td> Nasopharyngitis</td> <td>6 (5%)</td> <td>3 (3%)</td> </tr> <tr> <td> Pharyngitis streptococcal</td> <td>1 (1%)</td> <td>0 (0%)</td> </tr> <tr> <td> Upper respiratory tract infection</td> <td>10 (8%)</td> <td>2 (2%)</td> </tr> <tr> <td>Skin and subcutaneous tissue disorders</td> <td>4 (3%)</td> <td>2 (2%)</td> </tr> <tr> <td> Eczema asteatotic</td> <td>2 (2%)</td> <td>0 (0%)</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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