Overview
A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the thymidylate synthetase conversion of deoxyuridylic acid to thymidylic acid.
Indication
For the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Fluorouracil injection is indicated in the palliative management of some types of cancer, including colon, esophageal, gastric, rectum, breast, biliary tract, stomach, head and neck, cervical, pancreas, renal cell, and carcinoid.
Associated Conditions
- Actinic Keratosis (AK)
- Breast Cancer
- Colon Cancer
- Gastric Cancer
- Pancreatic Cancer
- Rectal Cancer
- Superficial Basal Cell Carcinoma
- Verruca (Warts)
- Hyperkeratotic actinic keratosis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/31 | Not Applicable | Not yet recruiting | |||
2025/07/31 | Not Applicable | Not yet recruiting | |||
2025/07/22 | Not Applicable | Not yet recruiting | |||
2025/07/17 | Not Applicable | Recruiting | |||
2025/07/17 | Not Applicable | Not yet recruiting | |||
2025/07/09 | Not Applicable | Recruiting | Zhejiang Doer Biologics Co., Ltd. | ||
2025/06/29 | Not Applicable | Not yet recruiting | |||
2025/06/27 | Not Applicable | Not yet recruiting | |||
2025/06/19 | Phase 2 | Not yet recruiting | GERCOR - Multidisciplinary Oncology Cooperative Group | ||
2025/06/17 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Encube Ethicals Private Limited | 21922-041 | TOPICAL | 50 mg in 1 mL | 11/7/2023 | |
| BluePoint Laboratories | 68001-524 | INTRAVENOUS | 50 mg in 1 mL | 10/27/2023 | |
| Taro Pharmaceutical Industries Ltd. | 52549-4118 | TOPICAL | 50 mg in 1 g | 8/18/2010 | |
| NuCare Pharmaceuticals,Inc. | 68071-3489 | TOPICAL | 50 mg in 1 g | 8/24/2023 | |
| Mayne Pharma Inc. | 51862-362 | TOPICAL | 50 mg in 1 g | 11/4/2021 | |
| Bausch Health US, LLC | 0187-5200 | TOPICAL | 5 mg in 1 g | 5/17/2021 | |
| NuCare Pharmaceuticals,Inc. | 68071-2961 | TOPICAL | 50 mg in 1 g | 3/20/2023 | |
| Accord Healthcare, Inc. | 16729-276 | INTRAVENOUS | 50 mg in 1 mL | 2/23/2017 | |
| Mylan Pharmaceuticals Inc. | 0378-8078 | TOPICAL | 5 mg in 1 g | 1/15/2019 | |
| Fresenius Kabi USA, LLC | 63323-117 | INTRAVENOUS | 50 mg in 1 mL | 4/24/2017 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| FLUOROURACIL INJECTION 50 mg/ml | SIN09904P | INJECTION | 50 mg/ml | 7/23/1998 | |
| DBL Fluorouracil Injection BP 50mg/mL | SIN05050P | INJECTION | 50 MG/ML | 9/6/1990 | |
| VERRUMAL SOLUTION | SIN04266P | SOLUTION | 0.5 g/100 g | 4/30/1990 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FLUOROURACIL EBEWE fluorouracil 1000mg/ 20mL solution for injection vial | 98545 | Medicine | A | 3/15/2006 | |
| Hospira Fluorouracil Injection BP 1 g/20 mL vial | 119432 | Medicine | A | 5/24/2005 | |
| FLUOROURACIL INTAS fluorouracil 5000 mg/100 mL injection vial | 285806 | Medicine | A | 6/8/2018 | |
| ACTIKERALL fluorouracil and salicylic acid 0.5% / 10% (w/w) topical solution, bottle | 287446 | Medicine | A | 8/15/2019 | |
| FLUOROURACIL EBEWE fluorouracil 5000 mg/100 mL solution for injection vial | 166741 | Medicine | A | 3/24/2011 | |
| Hospira Fluorouracil Injection BP 2.5 g/50 mL Vial | 380183 | Medicine | A | 12/3/2021 | |
| FLUOROURACIL INTAS fluorouracil 2500 mg/50 mL injection vial | 285804 | Medicine | A | 6/8/2018 | |
| FLUOROURACIL AGILA fluorouracil 5 g/100 mL solution for injection vial | 233665 | Medicine | A | 1/14/2022 | |
| Hospira Fluorouracil Injection USP 5g/100mL vial | 63029 | Medicine | A | 1/19/1998 | |
| FLUOROCREM fluorouracil 5%w/w cream tube | 384712 | Medicine | A | 5/23/2023 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| FLUOROURACIL INJECTION | generic medical partners inc | 02476711 | Solution - Intravenous | 250 MG / 5 ML | N/A |
| FLUOROURACIL INJECTION | biolyse pharma corporation | 02473771 | Solution - Intravenous | 5 G / 100 ML | 6/6/2019 |
| ADRUCIL | 02063921 | Solution - Intravenous | 50 MG / ML | 12/31/1995 | |
| FLUOROPLEX CREAM 1% | allergan herbert skin care division of allergan inc. | 01982311 | Cream - Topical | 1 % | 12/31/1992 |
| FLUOROURACIL INJECTION | generic medical partners inc | 02476746 | Solution - Intravenous | 1000 MG / 20 ML | N/A |
| ACTIKERALL | 02428946 | Solution - Topical | 0.5 % / W/W | 2/19/2016 | |
| EFUDEX | bausch health, canada inc. | 00330582 | Cream - Topical | 5 % / W/W | 12/31/1975 |
| ADRUCIL INJ 50MG/ML | adria laboratories of canada ltd. | 00428493 | Liquid - Intravenous | 500 MG / 10 ML | 12/31/1978 |
| FLUOROURACIL INJ 50MG/ML | david bull laboratories (pty) ltd. | 00891754 | Liquid - Intravenous | 50 MG / ML | 12/31/1993 |
| FLUOROURACIL INJECTION USP | 02182742 | Solution - Intravenous | 50 MG / ML | 11/25/1998 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| TOLAK 40 MG/G CREMA | Pierre Fabre Iberica S.A. | 84849 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| FLUOROURACILO ACCORD 50 mg/ml SOLUCION INYECTABLE O PARA PERFUSION EFG | 71868 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| ACTIKERALL 5 MG/G + 100 MG/G SOLUCION CUTANEA | 77675 | SOLUCIÓN CUTÁNEA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| VERRUCUTAN 5 MG/G + 100 MG/G SOLUCION CUTANEA | Mibe Pharma Espana S.L. | 86061 | SOLUCIÓN CUTÁNEA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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