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Drug ReportsFluorouracil
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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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
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YTD
1Y
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5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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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, Fluorouracil, Tolak (discontinued: Adrucil, Efudex, Fluoroplex, Fluorouracil)
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
fluoroplexNew Drug Application2022-03-14
fluorouracilANDA2025-02-14
fuzzylulu 5% minoxidil with biotin hair growth serumC2002632024-05-14
jabon shelo nabel con alantoina baba de caracolOTC monograph final2019-10-15
shelo nabel baba de caracolOTC monograph final2019-10-15
shelo nabel baba de caracol locion corporalOTC monograph final2019-10-15
shelo nabel crema baba de caracolOTC monograph final2019-10-15
tolakNew Drug Application2022-09-06
visage pro peach fuzzC2002632024-12-06
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
breast neoplasmsEFO_0003869D001943C50
pancreatic neoplasmsEFO_0003860D010190C25
stomach neoplasmsEFO_0003897D013274C16
head and neck neoplasms—D006258—
basal cell carcinoma—D002280—
colonic neoplasms—D003110C18
rectal neoplasms—D012004—
keratosis—D007642—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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
3180 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Actinic keratosisD055623—L57.0————11
KeratosisD007642——————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
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Structure (InChI/SMILES or Protein Sequence)
O=c1[nH]cc(F)c(=O)[nH]1
Identifiers
PDB—
CAS-ID51-21-8
RxCUI—
ChEMBL IDCHEMBL185
ChEBI ID46345
PubChem CID3385
DrugBankDB00544
UNII IDU3P01618RT (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Fluorouracil
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 34,578 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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74,579 adverse events reported
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