Fluorouracil
Carac, Efudex, Fluorouracil, Tolak (fluorouracil) is a small molecule pharmaceutical. Fluorouracil was first approved as Fluoroplex on 1982-01-01. It is used to treat basal cell carcinoma, breast neoplasms, colonic neoplasms, head and neck neoplasms, and keratosis amongst others in the USA.
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Carac, Efudex, Fluorouracil, Tolak (discontinued: Adrucil, Efudex, Fluoroplex, Fluorouracil)
Drug Products
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Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fluorouracil
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| EFUDEX | Bausch Health Companies | N-016831 RX | 1982-01-01 | 2 products, RLD, RS |
| TOLAK | Hill Dermaceuticals | N-022259 RX | 2015-09-18 | 1 products, RLD, RS |
| CARAC | Bausch Health Companies | N-020985 RX | 2000-10-27 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| efudex | New Drug Application | 2025-04-23 |
| fluorouracil | ANDA | 2025-11-18 |
| fuzzylulu 5% minoxidil with biotin hair growth serum | C200263 | 2024-05-14 |
| jabon shelo nabel con alantoina baba de caracol | OTC monograph final | 2019-10-15 |
| shelo nabel baba de caracol | OTC monograph final | 2019-10-15 |
| shelo nabel baba de caracol locion corporal | OTC monograph final | 2019-10-15 |
| shelo nabel crema baba de caracol | OTC monograph final | 2019-10-15 |
| tolak | New Drug Application | 2022-09-06 |
| visage pro peach fuzz | C200263 | 2025-12-17 |
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Clinical
Clinical Trials
4860 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 232 | 666 | 276 | 30 | 66 | 1135 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 95 | 302 | 203 | 15 | 42 | 604 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 160 | 328 | 80 | 4 | 38 | 527 |
| Rectal neoplasms | D012004 | — | — | 99 | 296 | 106 | 4 | 42 | 505 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 88 | 319 | 112 | 6 | 28 | 502 |
| Neoplasms | D009369 | — | C80 | 251 | 214 | 72 | 3 | 20 | 493 |
| Adenocarcinoma | D000230 | — | — | 67 | 225 | 52 | 3 | 15 | 319 |
| Carcinoma | D002277 | — | C80.0 | 39 | 179 | 80 | 3 | 40 | 312 |
| Colonic neoplasms | D003110 | — | C18 | 71 | 152 | 93 | 6 | 22 | 308 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 68 | 171 | 60 | 5 | 15 | 282 |
Show 49 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 31 | 82 | 31 | — | 5 | 135 |
| Nasopharyngeal neoplasms | D009303 | — | — | 1 | 55 | 45 | — | 9 | 105 |
| Esophageal squamous cell carcinoma | D000077277 | — | — | 15 | 68 | 27 | — | 7 | 104 |
| Nasopharyngeal carcinoma | D000077274 | — | — | 1 | 47 | 52 | — | 9 | 104 |
| Biliary tract neoplasms | D001661 | — | C24.9 | 19 | 63 | 11 | — | 8 | 87 |
| Triple negative breast neoplasms | D064726 | — | — | 17 | 50 | 22 | — | 1 | 80 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 27 | 34 | 5 | — | 1 | 56 |
| Non-small-cell lung carcinoma | D002289 | — | — | 38 | 24 | 1 | — | — | 52 |
| Gallbladder neoplasms | D005706 | EFO_0004606 | C23 | 10 | 32 | 12 | — | 2 | 52 |
| Anus neoplasms | D001005 | EFO_0003835 | C21 | 11 | 27 | 10 | — | 2 | 44 |
Show 132 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 9 | 6 | — | — | 1 | 15 |
| Lymphoma | D008223 | — | C85.9 | 13 | 5 | — | — | — | 15 |
| Melanoma | D008545 | — | — | 13 | 6 | — | — | — | 13 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 6 | 8 | — | — | 1 | 13 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 5 | 7 | — | — | — | 11 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 10 | 2 | — | — | — | 10 |
| Transitional cell carcinoma | D002295 | — | — | 3 | 8 | — | — | — | 9 |
| Sarcoma | D012509 | — | — | 6 | 4 | — | — | — | 9 |
| Small cell lung carcinoma | D055752 | — | — | 8 | 3 | — | — | — | 8 |
| Glioma | D005910 | EFO_0000520 | — | 6 | 4 | — | — | — | 8 |
Show 109 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 7 | — | — | — | — | 7 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 6 | — | — | — | — | 6 |
| Hodgkin disease | D006689 | — | C81 | 6 | — | — | — | — | 6 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 5 | — | — | — | — | 5 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 5 | — | — | — | — | 5 |
| Large-cell lymphoma anaplastic | D017728 | — | C84.6 | 5 | — | — | — | — | 5 |
| Burkitt lymphoma | D002051 | — | C83.7 | 5 | — | — | — | — | 5 |
| Large-cell lymphoma immunoblastic | D016400 | — | — | 5 | — | — | — | — | 5 |
| Immunoblastic lymphadenopathy | D007119 | EFO_1001350 | C86.5 | 4 | — | — | — | — | 4 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | 4 | — | — | — | — | 4 |
Show 78 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prognosis | D011379 | — | — | — | — | — | — | 3 | 3 |
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | — | — | — | 2 | 2 |
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | — | — | — | — | 2 | 2 |
| Apnea | D001049 | — | R06.81 | — | — | — | — | 2 | 2 |
| Chronic pain | D059350 | — | — | — | — | — | — | 2 | 2 |
| Vocal cord paralysis | D014826 | — | J38.0 | — | — | — | — | 2 | 2 |
| Depression | D003863 | — | F33.9 | — | — | — | — | 2 | 2 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | — | — | 1 | 1 |
| Body weight | D001835 | EFO_0004338 | — | — | — | — | — | 1 | 1 |
| Microbiota | D064307 | — | — | — | — | — | — | 1 | 1 |
Show 58 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fluorouracil |
| INN | fluorouracil |
| Description | 5-fluorouracil is a nucleobase analogue that is uracil in which the hydrogen at position 5 is replaced by fluorine. It is an antineoplastic agent which acts as an antimetabolite - following conversion to the active deoxynucleotide, it inhibits DNA synthesis (by blocking the conversion of deoxyuridylic acid to thymidylic acid by the cellular enzyme thymidylate synthetase) and so slows tumour growth. It has a role as a xenobiotic, an environmental contaminant, a radiosensitizing agent, an antineoplastic agent, an immunosuppressive agent and an antimetabolite. It is a nucleobase analogue and an organofluorine compound. It is functionally related to a uracil. |
| Classification | Small molecule |
| Drug class | uracil type antineoplastics; uracil derivatives used as thyroid antagonists and as antineoplastics |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=c1[nH]cc(F)c(=O)[nH]1 |
Identifiers
| PDB | — |
| CAS-ID | 51-21-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL185 |
| ChEBI ID | 46345 |
| PubChem CID | 3385 |
| DrugBank | DB00544 |
| UNII ID | U3P01618RT (ChemIDplus, GSRS) |
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Fluorouracil
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Safety
Black-box Warning
Black-box warning for: Fluorouracil
Adverse Events
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77,840 adverse events reported
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