Fluorouracil
Carac, Efudex, Tolak (fluorouracil) is a small molecule pharmaceutical. Fluorouracil was first approved as Efudex 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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Commercial
Trade Name
FDA
EMA
Carac, Efudex, Tolak (generic drugs available since 1998-09-30, discontinued: Adrucil, Fluoroplex)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
carac | New Drug Application | 2017-05-16 |
efudex | New Drug Application | 2020-04-01 |
fluoroplex | New Drug Application | 2020-10-16 |
fluorouracil | ANDA | 2023-05-10 |
tolak | New Drug Application | 2020-03-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
basal cell carcinoma | — | D002280 | — |
breast neoplasms | EFO_0003869 | D001943 | C50 |
colonic neoplasms | — | D003110 | C18 |
head and neck neoplasms | — | D006258 | — |
keratosis | — | D007642 | — |
pancreatic neoplasms | EFO_0003860 | D010190 | C25 |
rectal neoplasms | — | D012004 | — |
stomach neoplasms | EFO_0003897 | D013274 | C16 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Fluorouracil, Tolak, Hill Dermaceuticals | |||
7169401 | 2023-07-18 | DP |
Clinical
Clinical Trials
20 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Trichiasis | D058457 | HP_0001128 | — | — | 1 | — | 1 | 2 | |
Fibrosis | D005355 | — | — | 1 | — | — | 1 | ||
Glaucoma | D005901 | EFO_0000516 | H40 | — | — | 1 | — | — | 1 |
Trabeculectomy | D014130 | — | — | 1 | — | — | 1 | ||
Eye diseases | D005128 | EFO_0003966 | H44 | — | — | 1 | — | — | 1 |
Eyelid diseases | D005141 | EFO_0009547 | H02.9 | — | — | 1 | — | — | 1 |
Corneal opacity | D003318 | HP_0007957 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Lacrimal apparatus diseases | D007766 | HP_0009926 | H04 | — | 1 | — | — | — | 1 |
Neoplasms | D009369 | C80 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
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 | 4492 |
ChEMBL ID | CHEMBL185 |
ChEBI ID | 46345 |
PubChem CID | 3385 |
DrugBank | DB00544 |
UNII ID | U3P01618RT (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
---|---|---|---|---|
VCV001327419 | DPYD, 1543G>A, Val515Ile | drug response | 2021-05-25 | 1A |
VCV001327416 | DPYD, 1003G>T, Val335Leu | drug response | 2021-03-24 | 1A |
VCV001032887 | DPYD, 1156G>T, Glu386Ter | drug response | 2021-03-24 | 1A |
VCV000635267 | DPYD, 2983G>T, Val995Phe | drug response | 2021-03-24 | 1A |
VCV000635266 | DPYD, 1898del, Pro633fs | drug response | 2021-03-24 | 1A |
VCV000635263 | DPYD, 1129-5923C>G | drug response | 2021-05-24 | 1A |
VCV000298300 | DPYD, 703C>T, Arg235Trp | drug response | 2021-03-24 | 1A |
VCV000287480 | DPYD, 2303C>A, Thr768Lys | drug response | 2021-05-25 | 1A |
VCV000282919 | DPYD, 1774C>T, Arg592Trp | drug response | 2021-03-24 | 1A |
VCV000100116 | DPYD, 496A>G, Met166Val | drug response | 2021-03-29 | 1A |
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Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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857 adverse events reported
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