Product Information

Registration Status: Active

FLUOROURACIL INJECTION 50mg/ML is approved to be sold in Singapore with effective from 1998-07-23. It is marketed by DRUG HOUSES OF AUSTRALIA PTE LTD, with the registration number of SIN09904P.

This product contains Fluorouracil 50mg/ml in the form of INJECTION. It is approved for INTRAVENOUS use.

This product is manufactured by PHARMACHEMIE BV in NETHERLANDS.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.



A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the thymidylate synthetase conversion of deoxyuridylic acid to thymidylic acid. [PubChem]


For the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Fluorouracil injection is indicated in the palliative management of some types of cancer, including colon, esophageal, gastric, rectum, breast, biliary tract, stomach, head and neck, cervical, pancreas, renal cell, and carcinoid.

Mechanism of Action

The precise mechanism of action has not been fully determined, but the main mechanism of fluorouracil is thought to be the binding of the deoxyribonucleotide of the drug (FdUMP) and the folate cofactor, N5–10-methylenetetrahydrofolate, to thymidylate synthase (TS) to form a covalently bound ternary complex. This results in the inhibition of the formation of thymidylate from uracil, which leads to the inhibition of DNA and RNA synthesis and cell death. Fluorouracil can also be incorporated into RNA in place of uridine triphosphate (UTP), producing a fraudulent RNA and interfering with RNA processing and protein synthesis.


Hepatic. The catabolic metabolism of fluorouracil results in degradation products ( e.g., CO2, urea and α-fluoro-ß-alanine) which are inactive.


LD50=230mg/kg (orally in mice)

Active Ingredient/Synonyms

5-Fluoracil | 5-Fluoropyrimidine-2,4-dione | 5-Fluorouracil | 5-Fluracil | 5-FU | Fluoro Uracil | Fluorouracil | Fluorouracilo | Fluorouracilum | Fluoruracil | Fluouracil | FU | Fluorouracil |

Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.


  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank