warnings
WARNINGS Contact dermatitis, including allergic contact dermatitis, has been observed with the use of Dovonex ® Cream.
FDA label f005a702-6ff8-4219-ab42-ae3d81a5e875
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
- SPL set ID
- 75541479-7a55-4e28-b693-04de56f73f7b
- SPL ID
- f005a702-6ff8-4219-ab42-ae3d81a5e875
- Version
- 12
- Effective date
- 2020-01-22
- Source export date
- 2026-11-06
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 08:07:57
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | f005a702-6ff8-4219-ab42-ae3d81a5e875 | id | |
| spl set id | 75541479-7a55-4e28-b693-04de56f73f7b | set_id |
Warnings cross-check#
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Adverse reactions cross-check#
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adverse reactions
ADVERSE REACTIONS Clinical Trials Experience In controlled clinical trials, the most frequent adverse experiences reported for Dovonex ® (calcipotriene) Cream, 0.005% were cases of skin irritation, which occurred in approximately 10-15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients. Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions associated with the use of Dovonex ® Cream have been identified post-approval: contact dermatitis including allergic contact dermatitis, erythema, skin exfoliation, skin burning sensation, application site pain, application site pigmentation disorder, urticaria, photosensitivity, rash rash erythematous, rash maculo-papular, rash morbilliform, rash popular, and rash pustular , dry skin, hypercalcaemia and hypersensitivity.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.