FDA label 389cdebb-55fe-4808-a5b7-0f293d9ee45d

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
389cdebb-55fe-4808-a5b7-0f293d9ee45d
SPL ID
389cdebb-55fe-4808-a5b7-0f293d9ee45d
Version
1
Effective date
2010-09-14
Source export date
2026-11-06
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/2026-11-06/5731a8c92e1c0dd2a09d2f92b410e7a70ea29cbf6b8040a6a05e4be5b7c51f0d/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:41:55

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS The following local adverse reactions are reported infrequently when Betamethasone Dipropionate Ointment is used as recommended in the DOSAGE AND ADMINISTRATION section. 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, miliaria. Adverse reactions reported to be possibly or probably related to treatment with betamethasone dipropionate ointment during a pediatric clinical study include signs of skin atrophy (telangiectasia, thinness, shininess, bruising, loss of skin markings). Cutaneous atrophy of the face occurred in 1/6 (17%) of infants, 2/9 (22%) of 2-5 year olds, and 2/6 (33%) of the 6-8 year olds. Non-facial atrophy occurred in 15%, 8%, and 9% of 2-5 year olds, 6-8 year olds, and 9-12 year olds, respectively. 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.

Reported adverse events (FAERS/openFDA)#

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