FLUOROURACIL INJECTION USP
As listed in the register: FLUOROURACIL INJECTION USP
50 mg · solution
- Prescription only
- Cancer treatments and immune-system medicines
- Active substance
- Fluorouracil
- Made by
- Accord Healthcare Inc
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet retrieved and stored the official label for this product, so none of its text is shown here. Open the official leaflet
How it works
From the US prescribing label for the same active substance (Fluorouracil). It describes the substance, not this exact product.
Fluorouracil is a nucleoside metabolic inhibitor that interferes with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA); these affect rapidly growing cells and may lead to cell death.
Fluorouracil is converted to three main active metabolites: 5-fluoro-2′-deoxyuridine-5′-monophosphate (FdUMP), 5-fluorouridine-5′- triphosphate (FUTP) and 5-fluoro-2′-deoxyuridine-5′-triphosphate (FdUTP).
The remaining percentage of the administered dose is metabolized, primarily in the liver.
Following bolus intravenous injection, 5 – 20 % of the parent drug is excreted unchanged in the urine in six hours.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-07-15
Safety of the active substance
From the US prescribing label for the same active substance (Fluorouracil). It describes the substance, not this exact product.
WARNING: SERIOUS ADVERSE REACTIONS OR DEATH IN PATIENTS WITH COMPLETE DPD DEFICIENCY Increased Risk of Serious Adverse Reactions or Death in Patients with Complete DPD Deficiency Test patients for genetic variants of DPYD prior to initiating fluorouracil unless immediate treatment is necessary.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United States2 matching products
SpainNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Accord Healthcare Inc |
|---|---|
| Active substance | Fluorouracil |
| Used in | Cancer treatments and immune-system medicines |
| Strength | 50 mg |
| Form | solution |
| Classification | L01BC02 · Cancer treatments and immune-system medicines |
| Route | intravenous |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Marketed |
| Marketed | Yes, according to the register |
| DIN | 02413450 |
| DPD drug code | 89810 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.