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Drug ReportsFluorouracil
Fluorouracil
Carac, Efudex, Fluorouracil, 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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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
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1M
3M
6M
YTD
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2Y
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FDA approval date
EMA approval date
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Study first post date
Last update 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
caracNew Drug Application2021-05-17
efudexNew Drug Application2024-03-01
fluoroplexNew Drug Application2022-03-14
fluorouracilANDA2024-10-10
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
Show 1 more
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
3098 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 neoplasmsD015179——1544742252252838
CarcinomaD002277—C80.070264125352465
AdenocarcinomaD000230——9223272117368
Pancreatic neoplasmsD010190EFO_0003860C2510023261224365
NeoplasmsD009369—C8014613047315305
Stomach neoplasmsD013274EFO_0003897C164618369425299
Rectal neoplasmsD012004——4014855125248
Esophageal neoplasmsD004938—C154314745613227
Breast neoplasmsD001943EFO_0003869C50207290517196
Liver neoplasmsD008113EFO_1001513C22.0169955533191
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatocellular carcinomaD006528—C22.0108141—30151
Nasopharyngeal carcinomaD000077274——33433—974
Esophageal squamous cell carcinomaD000077277——74222—671
Nasopharyngeal neoplasmsD009303———3629—969
Pancreatic ductal carcinomaD021441——25356—359
Biliary tract neoplasmsD001661—C24.98334—239
Anus neoplasmsD001005EFO_0003835C218258—238
Renal cell carcinomaD002292EFO_0000376—19202—134
Peritoneal neoplasmsD010534——10156—331
Urinary bladder neoplasmsD001749—C674154—224
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289——2313———28
Ovarian neoplasmsD010051EFO_0003893C561415———25
LymphomaD008223—C85.9114———13
MelanomaD008545——106———10
Appendiceal neoplasmsD001063EFO_0003880C18.154——110
Endometrial neoplasmsD016889EFO_0004230—17——18
Transitional cell carcinomaD002295——16———6
Prostatic neoplasmsD011471—C6141——16
SyndromeD013577——23——16
Ovarian epithelial carcinomaD000077216——34———6
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C953————3
Myelodysplastic syndromesD009190—D462————2
Myeloid leukemia acuteD015470—C92.02————2
Myeloproliferative disordersD009196—D47.12————2
B-cell chronic lymphocytic leukemiaD015451—C91.12————2
PreleukemiaD011289——2————2
ChondrosarcomaD002813——2————2
Weight lossD015431HP_0001824—1———12
OligodendrogliomaD009837EFO_0000631—2————2
PregnancyD011247EFO_0002950Z33.11———12
Show 46 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PrognosisD011379——————22
Chronic painD059350HP_0012532—————22
Vocal cord paralysisD014826HP_0001605J38.0————22
ParalysisD010243HP_0003470—————22
Atrial fibrillationD001281EFO_0000275I48.0————11
Body weightD001835EFO_0004338—————11
StentsD015607——————11
Adjuvant chemoradiotherapyD059186——————11
Sclerosing cholangitisD015209EFO_0004268K83.01————11
CholangitisD002761HP_0030151K83.0————11
Show 46 more
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)Loading
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 29,559 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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70,311 adverse events reported
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