Table of contents

  • Brand Names
  • Drug Combinations
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Toxicological Effects
  • Caution and personalized dose adjustment in patients with the following genotypes
  • Other genes that may be involved
  • Substrate of
  • Inhibits
  • Drug Interactions
  • Nutrition/Nutraceutical Interactions
  • Dosage
  • Pharmacokinetics and Pharmacodynamics
  • Special Considerations

Brand Names


Austria: Fluorouracil; Belgium: Efudix, Fluracedyl, Fluroblastine; Bulgaria: Efudix, Fluorouracil; Cyprus: Fluorouracil; Czech Republic: Fluorouracil, La-Fu; Denmark: Fluorouracil, Flurablastin; Estonia: Fluorouracil; Finland: Flurablastin; France: Efudix, Fluorouracile; Germany: 5 FU-Cell, 5-Fluoro-Uracil, 5-FU, Alphauracil, Benda-5 FU, Efudix, Eurofluor, Fluorosachs, Haemato-Fu, Lafluor, Neofluor, Onkofluor, Ribofluor; Greece: Fluorouracil, Ribofluor; Hungary: 5-Fluoro-Uracil, Efudix, Fluorouracil; Ireland: Efudix, Fluorouracil; Italy: Fluorouracil; Latvia: Fluorouracil; Lithuania: Fluorouracil; Luxembourg: Efudix, Fluoro-Uracile, Fluroblastine; Malta: Efudix, Fluorouracil; Netherlands: Efudix, Fluracedyl, Fluorouracil; Poland: Efudix, Fluorouracil, Fluoro-Uracil, Fluroblastin; Portugal: Fluorouracilo; Romania: 5-Fluorouracil, Efudix, Fluorosindan; Slovakia: 5-Fluorouracil, Efudix, LA-FU; Slovenia: 5-Fluorouracil; Spain: Fluoro-Uracil, Fluorouracilo; Sweden: Fluorouracil, Flurablastin; UK: Efudix, Fluorouracil.

North America

Canada: Efudex, Fluoroplex, Fluorouracil; USA: Carac, Efudex, Fluoroplex, Fluorouracil.

Latin America

Argentina: Acler, Efudix, Fluoruracilo, Oncofu, Triosules; Brazil: Efurix, Fluoro-Uracil, Fluoruracila; Mexico: Carebin, Efudix, Fluoruracilo, Flurox.


Japan: 5-FU, Benton, Carzonal, Lunachol DS, Lunapon, Sanc F-D, Urosagen.

Drug combinations

Fluorouracil and Leucovorin

Fluorouracil and Salicylic Acid

Fluorouracil Bevacizumab, and Leucovorin

Fluorouracil, Cisplatin, and Docetaxel

Fluorouracil, Bevacizumab, Leucovorin and Oxaliplatin


Fluorouracil: C~4~H~3~FN~2~O~2~. Mw: 130.08. (1) 2,4(1H,3H)-Pyrimidinedione, 5-fluoro-; (2) 5-Fluorouracil. CAS-51-21-8 (1962).


Pharmacologic Category

Antineoplastic Agents; Antimetabolites; Pyrimidine Analog. (ATC-Code: L01BC02).

Mechanism of action

Fluorouracil, a pyrimidine antagonist, is an antimetabolite antineoplastic agent. May interfere with DNA synthesis, RNA processing, and protein synthesis.

Therapeutic use

Treatment of carcinomas of the breast, colon, head and neck, pancreas, rectum, or stomach. Topically for management of actinic or solar keratoses and superficial basal cell carcinomas.

Pregnancy and lactiation implications

Fetal defects and miscarriages reported following use of topical and I.V. products. Use contraindicated during pregnancy. Use not recommended during lactation.

Unlabeled use


Hypersensitivity to fluorouracil or any component of the formulation. Dihydropyrimidine dehydrogenase enzyme deficiency. Pregnancy.

Warnings and precautions

Hazardous agent. Palmar-plantar erythrodysesthesia (hand-foot) syndrome associated with use. Highly toxic. Caution when administered to dihydropyrimidine dehydrogenase deficiency patients (increased toxicity). Use extreme caution in history of high-dose pelvic irradiation, previous use of alkylating agents, widespread bone marrow metastases, impaired hepatic or renal function. Extreme caution when combined with leucovorin calcium in geriatric or debilitated patients (more likely to develop serious fluorouracil toxicity).



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