{"entity":{"id":"fluorouracil","kind":"drug","name":"Fluorouracil (5-FU)","aka":[],"tldr":"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.","summary":"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.","status":"approved","asOf":"2026-09-08","wikipedia":"https://en.wikipedia.org/wiki/Fluorouracil","links":[{"label":"Label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=fluorouracil%20injection"},{"label":"Jansen et al., five-year results of a randomised controlled trial comparing photodynamic therapy, topical imiquimod and topical 5-fluorouracil in superficial basal cell carcinoma (J Invest Dermatol 2018)","url":"https://doi.org/10.1016/j.jid.2017.09.033"},{"label":"Cancer Research UK: chemotherapy cream for non-melanoma skin cancer","url":"https://www.cancerresearchuk.org/about-cancer/skin-cancer/treatment/chemotherapy-cream"},{"label":"British Association of Dermatologists: basal cell carcinoma, patient information leaflet (updated July 2025)","url":"https://www.skinhealthinfo.org.uk/condition/basal-cell-carcinoma/"}],"tags":["gap-fill","generic","who-essential"],"related":["uridine-triacetate"],"cancers":["colorectal","gastric","pancreatic","anal","esophageal","head-and-neck","basal-cell-carcinoma","hepatoblastoma","anal-hsil-precursor","localised-anal-cancer","localised-penile-cancer","skin-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":[],"companies":["mast-therapeutics"],"institutions":[],"pathways":[],"terms":["topical-and-destructive-treatment-bcc"],"trials":["int-0116","cao-aro-aio-94","dbcg-82bc","nct07775287","nct07676162","nct04430738","nct06107413","nct06792695","nct07805551","nct05009069","nct05846867","nct06820463","nct04421820","nct05379595","nct04675333","nct05489211","nct06428409","nct07554521","nct06469944","nct06901531","nct04241185","nct04379596","nct07069712","nct07256782","nct06780111","nct06922383","nct01954992","mal-pdt-imiquimod-fluorouracil-superficial-bcc"],"people":[],"bottlenecks":[],"keyPapers":["paper-sauer-preoperative-chemoradiotherapy-rectal-nejm-2004"],"journals":[],"dependsOn":[],"notes":["As a cream for superficial basal cell carcinoma. In the Dutch randomised trial of 601 patients, fluorouracil cream was applied twice daily for four weeks, and the probability of tumour-free survival five years later was 70.0 percent, against 80.5 percent for imiquimod and 62.7 percent for photodynamic therapy; fluorouracil was inferior to imiquimod (hazard ratio 0.65 in favour of imiquimod, 95 percent confidence interval 0.43 to 0.98) and not significantly different from photodynamic therapy at that timepoint, having been found non-inferior to it at one and three years. The NHS says a chemotherapy cream is used once or twice a day for three to four weeks for cancers affecting only the top layer of skin."],"brand":"Adrucil / Efudex","modality":"Fluoropyrimidine antimetabolite","mechanism":"Converted to FdUMP (thymidylate synthase inhibition) and FUTP (RNA incorporation); potentiated by leucovorin; DPD deficiency causes severe toxicity.","approvals":[{"region":"US","year":1962,"indication":"Colorectal, breast, gastric and pancreatic adenocarcinoma"},{"region":"US","year":1970,"indication":"Topical: actinic keratosis and superficial basal cell carcinoma"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/fluorouracil/","neighbours":{"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"doxifluridine","kind":"drug","name":"Doxifluridine","route":"/drugs/doxifluridine/"},{"id":"floxuridine","kind":"drug","name":"Floxuridine","route":"/drugs/floxuridine/"},{"id":"folfoxiri","kind":"drug","name":"FOLFOXIRI (5-FU, leucovorin, oxaliplatin, irinotecan)","route":"/drugs/folfoxiri/"},{"id":"leucovorin","kind":"drug","name":"Leucovorin (folinic acid)","route":"/drugs/leucovorin/"},{"id":"raltitrexed","kind":"drug","name":"Raltitrexed","route":"/drugs/raltitrexed/"},{"id":"streptozocin","kind":"drug","name":"Streptozocin","route":"/drugs/streptozocin/"},{"id":"tegafur-gimeracil-oteracil","kind":"drug","name":"Tegafur, gimeracil and oteracil (S-1)","route":"/drugs/tegafur-gimeracil-oteracil/"},{"id":"uridine-triacetate","kind":"drug","name":"Uridine 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