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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
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
skin and connective tissue diseasesD017437
endocrine system diseasesD004700
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)
Fluorouracil
Tradename
Company
Number
Date
Products
EFUDEXBausch Health CompaniesN-016831 RX1982-01-01
2 products, RLD, RS
TOLAKHill DermaceuticalsN-022259 RX2015-09-18
1 products, RLD, RS
CARACBausch Health CompaniesN-020985 RX2000-10-27
1 products, RLD, RS
Show 5 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
caracNew Drug Application2017-05-16
efudexNew Drug Application2020-04-01
fluoroplexNew Drug Application2020-10-16
fluorouracilANDA2023-05-10
tolakNew Drug Application2020-03-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
basal cell carcinoma—D002280—
breast neoplasmsEFO_0003869D001943C50
colonic neoplasms—D003110C18
head and neck neoplasms—D006258—
keratosis—D007642—
pancreatic neoplasmsEFO_0003860D010190C25
rectal neoplasms—D012004—
stomach neoplasmsEFO_0003897D013274C16
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Fluorouracil, Tolak, Hill Dermaceuticals
71694012023-07-18DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01B: Antimetabolites
— L01BC: Pyrimidine analogues, antineoplastic antimetabolites
— L01BC02: Fluorouracil
— L01BC52: Fluorouracil, combinations
HCPCS
Code
Description
J9190
Injection, fluorouracil, 500 mg
S3722
Dose optimization by area under the curve (auc) analysis, for infusional 5-fluorouracil
Clinical
Clinical Trials
20 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Intraocular pressureD007429——12—3
Dry eye syndromesD015352H04.12——1113
Fuchs' endothelial dystrophyD005642EFO_0003946H18.51—1—1—2
RosaceaD012393L71———1—1
InflammationD007249———1—1
PseudophakiaD019591———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TrichiasisD058457HP_0001128——1—12
FibrosisD005355——1——1
GlaucomaD005901EFO_0000516H40——1——1
TrabeculectomyD014130——1——1
Eye diseasesD005128EFO_0003966H44——1——1
Eyelid diseasesD005141EFO_0009547H02.9——1——1
Corneal opacityD003318HP_0007957—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lacrimal apparatus diseasesD007766HP_0009926H04—1———1
NeoplasmsD009369C80—1———1
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pathologic dilatationD004108————22
KeratoconusD007640EFO_0004223H18.6————22
RegenerationD012038————22
PterygiumD011625H11.0————11
TrachomaD014141A71————11
Corneal ulcerD003320H16.0————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFLUOROURACIL
INNfluorouracil
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 classuracil 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-ID51-21-8
RxCUI4492
ChEMBL IDCHEMBL185
ChEBI ID46345
PubChem CID3385
DrugBankDB00544
UNII IDU3P01618RT (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
Identifier
Target mutation
Effect
Evaluation
Status
VCV001327419DPYD, 1543G>A, Val515Iledrug response2021-05-251A
VCV001327416DPYD, 1003G>T, Val335Leudrug response2021-03-241A
VCV001032887DPYD, 1156G>T, Glu386Terdrug response2021-03-241A
VCV000635267DPYD, 2983G>T, Val995Phedrug response2021-03-241A
VCV000635266DPYD, 1898del, Pro633fsdrug response2021-03-241A
VCV000635263DPYD, 1129-5923C>Gdrug response2021-05-241A
VCV000298300DPYD, 703C>T, Arg235Trpdrug response2021-03-241A
VCV000287480DPYD, 2303C>A, Thr768Lysdrug response2021-05-251A
VCV000282919DPYD, 1774C>T, Arg592Trpdrug response2021-03-241A
VCV000100116DPYD, 496A>G, Met166Valdrug response2021-03-291A
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Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 100,042 documents
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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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