FDA label 13cdccfa-f8fc-4b81-8fa7-1fa5a8da0338

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
13cdccfa-f8fc-4b81-8fa7-1fa5a8da0338
SPL ID
13cdccfa-f8fc-4b81-8fa7-1fa5a8da0338
Version
1
Effective date
2009-08-17
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 02:23:05

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS In clinical trials with CLOBEX® Shampoo, the following adverse reactions have been reported: burning/stinging, pruritus, edema, folliculitis, acne, dry skin, irritant dermatitis, alopecia, urticaria, skin atrophy and telangiectasia. The table below summarizes selected adverse events that occurred in at least 1% of subjects in the Phase 2 and 3 studies for scalp psoriasis. Summary of Selected Adverse Events ≥ 1% by Body System Clobetasol Vehicle Body System Propionate Shampoo Shampoo N=558 N=127 Skin and Appendages 49 (8.8%) 28 (22.0%) Discomfort Skin 26 (4.7%) 16 (12.6%) Pruritus 3 (0.5%) 9 (7.1%) Body As A Whole 33 (5.9%) 12 (9.4%) Headache 10 (1.8%) 1 (0.8%) The following additional local adverse reactions have been reported infrequently with other topical corticosteroids, and they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients.

adverse reactions table

<table ID="ia4c98904-0960-4b68-8b30-3fc30cad8e90" width="729"> <caption>Summary of Selected Adverse Events &#x2265; 1% by Body System</caption> <thead> <tr> <td> </td> <td>Clobetasol</td> <td>Vehicle</td> </tr> <tr> <td>Body System</td> <td>Propionate Shampoo</td> <td>Shampoo</td> </tr> <tr> <td> </td> <td>N=558</td> <td>N=127</td> </tr> </thead> <tbody> <tr> <td>Skin and Appendages</td> <td>49 (8.8%)</td> <td>28 (22.0%)</td> </tr> <tr> <td>Discomfort Skin</td> <td>26 (4.7%)</td> <td>16 (12.6%)</td> </tr> <tr> <td>Pruritus</td> <td>3 (0.5%)</td> <td>9 (7.1%)</td> </tr> <tr> <td>Body As A Whole</td> <td>33 (5.9%)</td> <td>12 (9.4%)</td> </tr> <tr> <td>Headache</td> <td>10 (1.8%)</td> <td>1 (0.8%)</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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