Urea
/api/v1/drug/ureaMechanism of action
Sourced from openFDAMechanism-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 openFDAApply 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 openFDAFor topical use only. Avoid contact with eyes, lips or mucous membranes.
Adverse reactions
Sourced from openFDATransient 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
- 1Diarrhoea1909.0%
- 2Fatigue1768.3%
- 3Nausea1537.2%
- 4Off Label Use1406.6%
- 5Drug Ineffective1115.2%
- 6Decreased Appetite1095.1%
- 7Dyspnoea1024.8%
- 8Vomiting1024.8%
- 9Rash974.6%
- 10Pain934.4%
- 11Headache904.2%
- 12Palmar-plantar Erythrodysaesthesia Syndrome833.9%
- 13Dizziness823.9%
- 14Arthralgia803.8%
- 15Hypertension763.6%
Literature
Recent PubMed references pinned to Urea as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- The Effect of Efavirenz and Rufinamide on the Pharmacokinetics and Safety of Quizartinib: Two Phase 1 Studies in Healthy Participants.Clinical and translational science · 2026 · Yoo Y, Zahir H, Inaba S, et al.PMID 42246253DOI 10.1111/cts.70619
- AFP Stimulates Glucose Metabolic Reprogramming Contributing to Hepatocellular Carcinoma Resist Sorafenib Through Activating PI3K/AKT Signalling Pathway.Journal of cellular and molecular medicine · 2026 · Zhou Y, Feng S, Chen Y, et al.PMID 42244055DOI 10.1111/jcmm.71226
- Interface-engineered nickel oxyhydroxide on carbon nanofibers for efficient urea oxidation and wastewater-to-energy conversion.PloS one · 2026 · Barakat NAM, Saadawi A, Erfan OM, et al.PMID 42241426DOI 10.1371/journal.pone.0347020
- Phenotypic Response Surfaces-Guided Optimization (PRS-OPT) of Propolis-Metformin-Regorafenib Combination Therapy for MASLD-Associated Hepatocellular Carcinoma.Oncology research · 2026 · Huang YS, Ma CY, Roan HY, et al.PMID 42238013DOI 10.32604/or.2026.074145
- [DEVELOPMENT OF FATAL IMMUNE CHECKPOINT INHIBITOR-ASSOCIATED ENCEPHALITIS FOLLOWING COMBINATION THERAPY WITH PEMBROLIZUMAB AND LENVATINIB IN A PATIENT WITH CLEAR CELL RENAL CELL CARCINOMA].Hinyokika kiyo. Acta urologica Japonica · 2026 · Takahashi D, Masui K, Takamori H, et al.PMID 42237495DOI 10.82687/actaurojp.72.5_165
- Co-Exposure of N-Methyl-N-Nitrosourea and Benzo[A]Pyrene Elicits Toxicity in Drosophila Melanogaster.Journal of biochemical and molecular toxicology · 2026 · Madu JC, Abolaji AO, Adaramoye OA, et al.PMID 42224440DOI 10.1002/jbt.70915
- Real-World Usage of a Paclitaxel-Coated Balloon With Urea Compared With Other Contemporary Drug-Coated Balloons: A 2-Year Analysis From SCAAR in Over 6000 Patients.Journal of the American Heart Association · 2026 · von Koch S, Frank E, Gabrysch K, et al.PMID 42216271DOI 10.1161/JAHA.125.045621
- Challenges and opportunities in hydroxyurea access and adherence for sickle cell disease patients at Komfo Anokye Teaching Hospital: Insights from healthcare providers.PloS one · 2026 · Mensah J, Marfo AFA, Opare-Addo MNA, et al.PMID 42213654DOI 10.1371/journal.pone.0347848
Clinical trials
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.
- Ibrutinib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or Older Patients With Newly Diagnosed Mantle Cell LymphomaActive not recruiting · Phase 2 · Interventional · 113 enrolled · M.D. Anderson Cancer CenterNCT01880567updated 2026-06-12
- Sorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell CancerActive not recruiting · Phase 2 · Interventional · 48 enrolled · M.D. Anderson Cancer CenterNCT00494182updated 2026-06-12
- Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)Recruiting · Phase 3 · Interventional · 300 enrolled · Merck Sharp & Dohme LLCNCT06456346updated 2026-06-12
- A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent GlioblastomaRecruiting · Phase 2 · Phase 3 · Interventional · 2,250 enrolled · Global Coalition for Adaptive ResearchNCT03970447updated 2026-06-12
- Evaluation of Efficacy and Safety of Rituximab and Mycophenolate Mofetil Combination in Patients With Interstitial Lung Disease Related to Systemic SclerosisRecruiting · Phase 3 · Interventional · 102 enrolled · University Hospital, ToursNCT06549231updated 2026-06-12
- Assessment of Survival and Autonomy With Rituximab Plus Chemotherapy or Rituximab Plus Lenalidomide for Elderly Patients With Relapsed Diffuse Large B-cell LymphomaCompleted · Phase 2 · Interventional · 1 enrolled · Centre Hospitalier Universitaire, AmiensNCT04113226updated 2026-06-12
- Impact of Treatment With Rituximab on the Progression of Humoral Acute Rejection After Renal TransplantationCompleted · Phase 3 · Interventional · 40 enrolled · University Hospital, ToursNCT01350882updated 2026-06-12
- Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine ModelsRecruiting · Phase 2 · Interventional · 40 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)NCT02015013updated 2026-06-12
- NK010 or NK042 in Combination With Rituximab for Refractory Systemic Lupus Erythematosus/Lupus NephritisRecruiting · Phase 1 · Interventional · 18 enrolled · Guangdong Provincial People's HospitalNCT06676631updated 2026-06-12
- Study to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia VeraActive not recruiting · Observational · 242 enrolled · Novartis PharmaceuticalsNCT05548062updated 2026-06-11
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.
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.