OnCo
drugsProductNot mapped hereapproved

Fluorouracil (5-FU)

The 1957 chemotherapy that remains the backbone of treatment for bowel, stomach, pancreatic, anal, head and neck and breast cancers, and as a cream for skin precancers.

Heidelberger (1957). Infusional 5-FU with leucovorin is the core of FOLFOX/FOLFIRI/FOLFIRINOX, chemoradiation (rectal, anal, oesophageal, pancreatic, head and neck), and adjuvant colon therapy; capecitabine is its oral prodrug. DPYD genotyping before use is now recommended (EMA 2020; FDA label 2024). Topical 5-FU treats actinic keratosis and superficial BCC.

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5-Fluorouracil
PubChem
Modality
Fluoropyrimidine antimetabolite
Mechanism
Converted to FdUMP (thymidylate synthase inhibition) and FUTP (RNA incorporation); potentiated by leucovorin; DPD deficiency causes severe toxicity.
Brand / code
Adrucil / Efudex
Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. HCPCS J9190. When 5-FU is infused over 46 hours through an ambulatory pump at home, the drug and pump are paid under the Part B durable medical equipment benefit. Topical fluorouracil (Efudex) for skin lesions is Part D.

Commercial insurance
covered on label

Multi-source generic; covered under the medical benefit without prior authorisation in most plans, as part of standard regimens.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Not appraisedSearch NICE
Notes
Generic backbone of colorectal, gastric, pancreatic, breast and head and neck regimens for 60 years; funded routinely. NHS England has required DPYD testing before fluoropyrimidines since 2020.
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE search: fluorouracil. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US1962Colorectal, breast, gastric and pancreatic adenocarcinoma
US1970Topical: actinic keratosis and superficial basal cell carcinoma

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
3980 studies11 recruiting80 Phase 228 Phase 3
Search “Fluorouracil” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Fluorouracil (5-FU)
intervention: Fluorouracil
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Fluorouracil" OR ABSTRACT:"Fluorouracil" OR TITLE:"5-FU" OR ABSTRACT:"5-FU" OR TITLE:"Adrucil" OR ABSTRACT:"Adrucil" OR TITLE:"Efudex" OR ABSTRACT:"Efudex") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Fluorouracil (5-FU), not a curated reading list.

Connected

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