pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Physiochemical Activity.

Indications

Sourced from openFDA
  • For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.ICD-10: L40.9

Contraindications

Sourced from openFDA
  • Known hypersensitivity to any of the listed ingredients.contraindicated

Dosage & administration

Sourced from openFDA

Apply Urea 40% to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.

Warnings & precautions

Sourced from openFDA

For topical use only. Avoid contact with eyes, lips or mucous membranes.

Adverse reactions

Sourced from openFDA

Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product. To report SUSPECTED ADVERSE REACTIONS, contact Method Pharmaceuticals, LLC at 1-877-250-3427; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Pharmacokinetics

Sourced from openFDA
Metabolism
The mechanism of action of topically applied urea is not yet known.

Approval history

Sourced from openFDA
  • Dec 17, 2002NDANDA021314Meridian Bioscience

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2,122 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Diarrhoea1909.0%
  2. 2Fatigue1768.3%
  3. 3Nausea1537.2%
  4. 4Off Label Use1406.6%
  5. 5Drug Ineffective1115.2%
  6. 6Decreased Appetite1095.1%
  7. 7Dyspnoea1024.8%
  8. 8Vomiting1024.8%
  9. 9Rash974.6%
  10. 10Pain934.4%
  11. 11Headache904.2%
  12. 12Palmar-plantar Erythrodysaesthesia Syndrome833.9%
  13. 13Dizziness823.9%
  14. 14Arthralgia803.8%
  15. 15Hypertension763.6%

Literature

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Recent PubMed references pinned to Urea as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 4,288 ClinicalTrials.gov registrations naming Urea as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Urea work?
Mechanism-of-action class: Physiochemical Activity.
What is Urea used for?
According to FDA labeling, Urea carries indications including: For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Urea?
Urea is classified as Carbamide products, Solutions producing osmotic diuresis, Physiochemical Activity, Emollient Activity, Increased Renal Urea Excretion.
What are the brand names for Urea?
Urea is marketed under brand names including Aluvea, Aqua Care, Aquaphilic with Urea, Atrac-Tain, CEM-Urea, Carmol, Epimide 50, Gormel.
What are the contraindications for Urea?
Urea labeling lists contraindications including: Known hypersensitivity to any of the listed ingredients.. Always consult the full prescribing information and a clinician.
Note. Data for urea is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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