{"id":"5-fu","rwe":[{"pmid":"41904820","year":"2026","title":"Anti-Cancer Effect of a New 5-FU Derivative Containing Triazole-Bearing Mannose (5-FUD-MAN) Against Human Breast Cancer Cells Through LC3B-Mediated Cell Death.","finding":"","journal":"Journal of biochemical and molecular toxicology","studyType":"Clinical Study"},{"pmid":"41902997","year":"2026","title":"The logarithmic phase as a therapeutic direction: evaluating pharmacological strategies against cancer progression.","finding":"","journal":"Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico","studyType":"Clinical Study"},{"pmid":"41900880","year":"2026","title":"pH-Responsive ZIF-8 Precisely Induces Apoptosis of Oral Squamous Cell Carcinoma over Orofacial Mesenchymal Stem Cells.","finding":"","journal":"Pharmaceutics","studyType":"Clinical Study"},{"pmid":"41898777","year":"2026","title":"Baicalin Augments 5-Fluorouracil Efficacy in Colorectal Cancer by Triggering MLKL-Dependent Necroptosis: A Novel Strategy to Overcome Chemoresistance.","finding":"","journal":"International journal of molecular sciences","studyType":"Clinical Study"},{"pmid":"41898509","year":"2026","title":"LRRC8A Inhibition Overcomes Chemoresistance by Downregulating MRP3 and CYP3A4 in the 3D Spheroid Model of Human Breast Cancer Cells.","finding":"","journal":"International journal of molecular sciences","studyType":"Clinical Study"}],"tags":[{"label":"Nucleoside Metabolic Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Aromatase","category":"target"},{"label":"CYP19A1","category":"gene"},{"label":"ABCC11","category":"gene"},{"label":"ABCC5","category":"gene"},{"label":"L01BC02","category":"atc"},{"label":"Topical","category":"route"},{"label":"Intravenous","category":"route"},{"label":"Cream","category":"form"},{"label":"Injection","category":"form"},{"label":"Solution","category":"form"},{"label":"Active","category":"status"},{"label":"Actinic keratosis","category":"indication"},{"label":"Adenocarcinoma of pancreas","category":"indication"},{"label":"Malignant tumor of colon","category":"indication"},{"label":"Malignant tumor of stomach","category":"indication"},{"label":"Metastasis from malignant tumor of colon","category":"indication"},{"label":"Metastatic Breast Carcinoma","category":"indication"},{"label":"Spectrum Pharms","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Antimetabolites","category":"pharmacology"},{"label":"Antimetabolites, Antineoplastic","category":"pharmacology"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Immunologic Factors","category":"pharmacology"},{"label":"Immunosuppressive Agents","category":"pharmacology"},{"label":"Noxae","category":"pharmacology"}],"phase":"marketed","safety":{"safetySignals":[{"llr":4658.965,"date":"","count":4586,"signal":"Neutropenia","source":"DrugCentral FAERS","actionTaken":"Reported 4,586 times (LLR=4659)"},{"llr":2578.395,"date":"","count":2570,"signal":"Neuropathy peripheral","source":"DrugCentral FAERS","actionTaken":"Reported 2,570 times (LLR=2578)"},{"llr":2422.106,"date":"","count":1778,"signal":"Mucosal inflammation","source":"DrugCentral FAERS","actionTaken":"Reported 1,778 times (LLR=2422)"},{"llr":2302.924,"date":"","count":6140,"signal":"Diarrhoea","source":"DrugCentral FAERS","actionTaken":"Reported 6,140 times (LLR=2303)"},{"llr":2280.448,"date":"","count":2659,"signal":"Disease progression","source":"DrugCentral FAERS","actionTaken":"Reported 2,659 times (LLR=2280)"},{"llr":1888.525,"date":"","count":2509,"signal":"Febrile neutropenia","source":"DrugCentral FAERS","actionTaken":"Reported 2,509 times (LLR=1889)"},{"llr":1707.828,"date":"","count":2648,"signal":"Thrombocytopenia","source":"DrugCentral FAERS","actionTaken":"Reported 2,648 times (LLR=1708)"},{"llr":1702.075,"date":"","count":702,"signal":"Dermatitis acneiform","source":"DrugCentral FAERS","actionTaken":"Reported 702 times (LLR=1702)"},{"llr":1573.125,"date":"","count":1011,"signal":"Palmar-plantar erythrodysaesthesia syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 1,011 times (LLR=1573)"},{"llr":1494.602,"date":"","count":630,"signal":"Skin toxicity","source":"DrugCentral FAERS","actionTaken":"Reported 630 times (LLR=1495)"},{"llr":1428.76,"date":"","count":926,"signal":"Neurotoxicity","source":"DrugCentral FAERS","actionTaken":"Reported 926 times (LLR=1429)"},{"llr":1326.804,"date":"","count":1558,"signal":"Leukopenia","source":"DrugCentral FAERS","actionTaken":"Reported 1,558 times (LLR=1327)"},{"llr":1069.672,"date":"","count":1510,"signal":"Malignant neoplasm progression","source":"DrugCentral FAERS","actionTaken":"Reported 1,510 times (LLR=1070)"},{"llr":999.06,"date":"","count":422,"signal":"Arteriospasm coronary","source":"DrugCentral FAERS","actionTaken":"Reported 422 times (LLR=999)"},{"llr":984.85,"date":"","count":722,"signal":"Metastases to liver","source":"DrugCentral FAERS","actionTaken":"Reported 722 times (LLR=985)"}],"drugInteractions":[{"url":"/drug/cyp2c9-substrates","drug":"CYP2C9 Substrates","action":"Use caution","effect":"Strong CYP2C9 Inhibitors - CYP2C9 Substrates","source":"DrugCentral","drugSlug":"cyp2c9-substrates"},{"url":"/drug/warfarin","drug":"warfarin","action":"Avoid combination","effect":"May interact with Fluorouracil, Warfarin","source":"DrugCentral","drugSlug":"warfarin"}],"commonSideEffects":[],"contraindications":["Acute infectious disease","Acute vomiting","Angina pectoris","Bleeding","Bone marrow depression","Breastfeeding (mother)","Diarrhea","Dihydrouracil dehydrogenase (NADP^+^) deficiency","Disease of liver","Gastrointestinal hemorrhage","Kidney disease","Leukopenia","Neutropenic disorder","Nutritional disorder","Palmar-Plantar Erythrodysesthesia","Pharyngitis","Pregnancy, function","Secondary malignant neoplasm of bone marrow","Stomatitis","Superficial ulcer of skin","Thrombocytopenic disorder"],"specialPopulations":{"Pregnancy":"There are no adequate and well-controlled studies with fluorouracil in pregnant women. Based on its mechanism of action, fluorouracil can cause fetal harm when administered to pregnant woman. Administration of fluorouracil to rats and mice during selected periods of organogenesis, at doses lower than human dose of 12 mg/kg, caused embryolethality and teratogenicity. Malformations included cleft palate and skeletal defects. In monkeys, maternal doses of fluorouracil higher than an approximate human dose of 12 mg/kg resulted in abortion. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to fetus [see Clinical Pharmacology (12.1)].","Geriatric use":"No significant differences in safety and efficacy measures were demonstrated in patients age 65 and older compared to all other patients.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established."}},"trials":[],"aliases":[],"company":"Spectrum Pharms","patents":[{"source":"FDA Orange Book via DrugCentral","expires":"2023-07-18","territory":"US","patentNumber":"7169401"}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=5-fu","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:47:42.652546+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T23:47:42.652478+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T23:47:57.741747+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:47:48.275846+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=5-fu","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:47:48.503689+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5795238/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:47:49.539600+00:00"}},"allNames":"carac","offLabel":[],"synonyms":["5-fluorouracil","adrucil","fluoroblastin","fluorouracil","5-FU"],"timeline":[{"date":"1962-04-25","type":"positive","source":"DrugCentral","milestone":"FDA approval (Spectrum Pharms)"},{"date":"2018-09-21","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Kyowa Hakko Kirin Co., Ltd.)"}],"aiSummary":"Carac, a 5-fluorouracil topical cream marketed by Spectrum Pharms, holds a niche position in the treatment of actinic keratosis. Its key strength lies in its mechanism of action, which effectively interferes with DNA synthesis, hindering cancer cell replication. The primary risk is the upcoming key composition patent expiry in 2028, which could lead to increased competition from generics.","brandName":"Carac","ecosystem":[{"indication":"Actinic keratosis","otherDrugs":[{"name":"aminolevulinic acid","slug":"aminolevulinic-acid","company":"Dusa"},{"name":"diclofenac","slug":"diclofenac","company":""},{"name":"imiquimod","slug":"imiquimod","company":"Medicis"},{"name":"ingenol mebutate","slug":"ingenol-mebutate","company":"Leo Pharma As"}],"globalPrevalence":null},{"indication":"Adenocarcinoma of pancreas","otherDrugs":[{"name":"erlotinib","slug":"erlotinib","company":"Osi Pharms"},{"name":"gemcitabine","slug":"gemcitabine","company":"Lilly"},{"name":"irinotecan","slug":"irinotecan","company":"Pfizer Inc"},{"name":"mitomycin","slug":"mitomycin","company":""}],"globalPrevalence":null},{"indication":"Malignant tumor of colon","otherDrugs":[{"name":"cetuximab","slug":"cetuximab","company":"Imclone"},{"name":"tipiracil","slug":"tipiracil","company":"Taiho Oncology Inc"},{"name":"trifluridine","slug":"trifluridine","company":"Monarch Pharms"}],"globalPrevalence":null},{"indication":"Malignant tumor of stomach","otherDrugs":[{"name":"capecitabine","slug":"capecitabine","company":"Hoffmann La Roche"},{"name":"docetaxel","slug":"docetaxel","company":"Sanofi Aventis Us"},{"name":"levofolinic acid","slug":"levofolinic-acid","company":"Spectrum Pharms"},{"name":"nivolumab","slug":"nivolumab","company":"Bristol Myers Squibb"}],"globalPrevalence":null},{"indication":"Metastasis from malignant tumor of colon","otherDrugs":[{"name":"aflibercept","slug":"aflibercept","company":"Regeneron Pharmaceuticals"},{"name":"capecitabine","slug":"capecitabine","company":"Hoffmann La Roche"},{"name":"irinotecan","slug":"irinotecan","company":"Pfizer Inc"},{"name":"oxaliplatin","slug":"oxaliplatin","company":""}],"globalPrevalence":null},{"indication":"Metastatic Breast Carcinoma","otherDrugs":[{"name":"capecitabine","slug":"capecitabine","company":"Hoffmann La Roche"},{"name":"docetaxel","slug":"docetaxel","company":"Sanofi Aventis Us"},{"name":"doxorubicin","slug":"doxorubicin","company":""},{"name":"eribulin","slug":"eribulin","company":"Eisai Inc"}],"globalPrevalence":null},{"indication":"Small intestine cancer","otherDrugs":[{"name":"levofolinic acid","slug":"levofolinic-acid","company":"Spectrum Pharms"},{"name":"oxaliplatin","slug":"oxaliplatin","company":""}],"globalPrevalence":null},{"indication":"Superficial basal cell carcinoma","otherDrugs":[{"name":"imiquimod","slug":"imiquimod","company":"Medicis"}],"globalPrevalence":null}],"mechanism":{"target":"Aromatase","novelty":"Follow-on","targets":[{"gene":"CYP19A1","source":"DrugCentral","target":"Aromatase","protein":"Aromatase"},{"gene":"ABCC11","source":"DrugCentral","target":"ATP-binding cassette sub-family C member 11","protein":"ATP-binding cassette sub-family C member 11"},{"gene":"ABCC5","source":"DrugCentral","target":"Multidrug resistance-associated protein 5","protein":"Multidrug resistance-associated protein 5"},{"gene":"TYMS","source":"DrugCentral","target":"Thymidylate synthase","protein":"Thymidylate synthase"}],"moaClass":"Nucleic Acid Synthesis Inhibitors","modality":"Small Molecule","drugClass":"Nucleoside Metabolic Inhibitor","explanation":"","oneSentence":"","technicalDetail":"Carac (5-fluorouracil) is a thymidylate synthase inhibitor that works by incorporating into DNA and RNA, causing chain termination and disrupting nucleic acid synthesis, ultimately leading to cell death."},"commercial":{"launchDate":"1962","_launchSource":"DrugCentral (FDA 1962-04-25, SPECTRUM PHARMS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/26","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=5-fu","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=5-fu","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T02:29:52.507789","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-19T23:47:57.741865+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"cytarabine","drugSlug":"cytarabine","fdaApproval":"1969-06-17","genericCount":9,"patentStatus":"Off-patent — generic 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Carcinoma","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":null},{"name":"Small intestine cancer","source":"DrugCentral","snomedId":363509000,"regulator":"FDA","eligibility":null},{"name":"Superficial basal cell carcinoma","source":"DrugCentral","snomedId":403914000,"regulator":"FDA","eligibility":"Isolated, easily accessible basal cell carcinomas, lesions with multiple actinic or solar keratoses"}],"offLabel":[{"name":"Actinic cheilitis","source":"DrugCentral","drugName":"5-fu","evidenceCount":19,"evidenceLevel":"moderate"},{"name":"Biliary Tract Malignancy","source":"DrugCentral","drugName":"5-fu","evidenceCount":818,"evidenceLevel":"strong"},{"name":"Carcinoid syndrome","source":"DrugCentral","drugName":"5-fu","evidenceCount":60,"evidenceLevel":"strong"},{"name":"Carcinoma of breast","source":"DrugCentral","drugName":"5-fu","evidenceCount":8687,"evidenceLevel":"strong"},{"name":"Leukoplakia of oral mucosa","source":"DrugCentral","drugName":"5-fu","evidenceCount":7,"evidenceLevel":"emerging"},{"name":"Malignant tumor of anus","source":"DrugCentral","drugName":"5-fu","evidenceCount":827,"evidenceLevel":"strong"},{"name":"Malignant tumor of cervix","source":"DrugCentral","drugName":"5-fu","evidenceCount":297,"evidenceLevel":"strong"},{"name":"Malignant tumor of esophagus","source":"DrugCentral","drugName":"5-fu","evidenceCount":3267,"evidenceLevel":"strong"},{"name":"Malignant tumor of head and/or neck","source":"DrugCentral","drugName":"5-fu","evidenceCount":511252,"evidenceLevel":"strong"},{"name":"Malignant tumor of urinary bladder","source":"DrugCentral","drugName":"5-fu","evidenceCount":610,"evidenceLevel":"strong"},{"name":"Metastatic Malignant Tumor of Anus","source":"DrugCentral","drugName":"5-fu"},{"name":"Neoplasm of glans penis","source":"DrugCentral","drugName":"5-fu"},{"name":"Pancreatic Neuroendocrine Tumor","source":"DrugCentral","drugName":"5-fu"},{"name":"Radiation dermatitis","source":"DrugCentral","drugName":"5-fu"}],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"cytarabine","brandName":"cytarabine","genericName":"cytarabine","approvalYear":"1969","relationship":"same-class"},{"drugId":"gemcitabine","brandName":"gemcitabine","genericName":"gemcitabine","approvalYear":"1996","relationship":"same-class"},{"drugId":"capecitabine","brandName":"capecitabine","genericName":"capecitabine","approvalYear":"1998","relationship":"same-class"},{"drugId":"azacitidine","brandName":"azacitidine","genericName":"azacitidine","approvalYear":"2004","relationship":"same-class"},{"drugId":"decitabine","brandName":"decitabine","genericName":"decitabine","approvalYear":"2006","relationship":"same-class"},{"drugId":"floxuridine","brandName":"floxuridine","genericName":"floxuridine","approvalYear":"1970","relationship":"same-class"},{"drugId":"trifluridine","brandName":"trifluridine","genericName":"trifluridine","approvalYear":"1980","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT04929028","phase":"PHASE2","title":"Therapy 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