warnings
WARNINGS Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene.
Calcipotriene
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
- Brand name
- Calcipotriene
- Generic name
- CALCIPOTRIENE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 1bc020e0-b5ae-4cda-aa5b-87fa0452a6bc
- SPL ID
- a281edd2-1ec3-440c-9823-1c7541ff8c83
- Version
- 9
- Effective date
- 2026-01-23
- Source export date
- 2026-10-12
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:31:58
| Harmonized routes |
|---|
| TOPICAL |
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 |
|---|---|---|---|
| application applno | ANDA | 090633 | derived:openfda.application_number |
| application number | ANDA090633 | openfda.application_number | |
| brand name | Calcipotriene | openfda.brand_name | |
| generic name | CALCIPOTRIENE | openfda.generic_name | |
| manufacturer name | Glenmark Pharmaceuticals Inc., USA | openfda.manufacturer_name | |
| ndc | package | 68462-310-66 | openfda.package_ndc |
| ndc | package | 68462-310-65 | openfda.package_ndc |
| ndc | product | 68462-310 | openfda.product_ndc |
| ndc11 | package | 68462031065 | derived:openfda.package_ndc |
| ndc11 | package | 68462031066 | derived:openfda.package_ndc |
| rxcui | 198373 | openfda.rxcui | |
| spl id | a281edd2-1ec3-440c-9823-1c7541ff8c83 | id | |
| spl set id | 1bc020e0-b5ae-4cda-aa5b-87fa0452a6bc | set_id | |
| unii | 143NQ3779B | openfda.unii |
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 reactions reported for calcipotriene were burning, itching and skin irritation, which occurred in approximately 10 to 15% of patients. Erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis including development of facial/scalp psoriasis were reported in 1 to 10% of patients. Other experiences reported in less than 1% of patients included skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis. Once daily dosing has not been shown to be superior in safety to twice daily dosing. Postmarketing Experience The following adverse reactions have been identified during post approval use of Dovonex Ointment. 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. Renal and urinary disorders: hypercalciuria Skin and subcutaneous tissue disorders: application site edema, application site pain, contact dermatitis (including allergic contact dermatitis), depigmentation, hypopigmentation, photosensitivity, rash (including erythematous, maculo-papular, and pustular), and urticaria.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.