Floxuridine
Floxuridine is a chemotherapy medicine given by continuous infusion into an artery to ease (palliate) gastrointestinal cancer that has spread to the liver.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →
Floxuridine (Fudr) is a strong chemotherapy drug that blocks cells from making DNA (and, less so, RNA), given as a continuous infusion into the artery feeding the liver to ease, not cure, digestive tract cancer (adenocarcinoma) that has spread there; it is a specialist treatment, on the market since about 1970 and available generically. It is hard on the body, and nausea, vomiting, diarrhea and mouth sores are what people most often notice. Its boxed warning is for severe toxic reactions, so the first course is given in the hospital under a doctor experienced in arterial chemotherapy. Report fever, bleeding or severe stomach pain to your cancer team quickly.
Clinical pearls
- Low blood counts and abnormal liver tests are common, so expect regular blood work, including liver tests, throughout treatment.
- Watch the catheter or pump site and report redness, pain, bleeding or leaking, which can signal infection or a line problem.
- Tell your oncologist about past pelvic radiation or alkylating chemotherapy, since either calls for extra caution with this drug.
- Floxuridine can harm an unborn baby, so women who could become pregnant should avoid pregnancy during treatment.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Floxuridine can cause severe toxic reactions, so all patients should be hospitalized when starting the first course.
It is a potent chemotherapy drug and should be given only by or under the supervision of a physician experienced in cancer chemotherapy and intra-arterial drug therapy. Tell your care team right away about any new or worsening symptoms during treatment.
Patient information guide — a plain-language walkthrough of Floxuridine, written from its FDA label.
What Floxuridine is used for
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Floxuridine is a chemotherapy medicine with one supported use.
- Floxuridine for Injection (intra-arterial) is used for palliative management of gastrointestinal adenocarcinoma that has spread to the liver.
- It is given by continuous regional infusion in carefully selected patients considered incurable by surgery or other means.
- Patients whose disease extends beyond an area reachable through a single artery should usually be considered for systemic therapy with other chemotherapy drugs.
How Floxuridine works
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Floxuridine is an antimetabolite. It mainly interferes with making DNA and, to a lesser extent, RNA, which cancer cells need to grow.
If injected rapidly, the body quickly converts it to 5-fluorouracil, with similar toxic effects. With continuous infusion, more of it is converted directly to a form that blocks DNA even more.
Floxuridine dosage
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Floxuridine for Injection is given as a continuous infusion into an artery, usually with a pump for a steady rate. The powder is mixed with sterile water, then diluted with 5% dextrose or 0.9% sodium chloride.
- The first course is given in the hospital.
- Treatment can continue until side effects appear, and may be resumed once they subside.
- It continues as long as you keep responding to it.
Your doctor sets the dose and schedule.
Dosing details from the FDA-approved label
From the Floxuridine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Continuous arterial infusion (recommended therapeutic dosage schedule)
- 0.1 to 0.6 mg/kg/day by continuous arterial infusion
- Higher dosage ranges (0.4 to 0.6 mg) are usually employed for hepatic artery infusion
- Higher range used for hepatic artery infusion because the liver metabolizes the drug, reducing potential for systemic toxicity; therapy can be given until adverse reactions appear, then resumed when they subside
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION Each vial must be reconstituted with 5 mL of sterile water for injection to yield a solution containing approximately 100 mg of floxuridine/mL. The calculated daily dose(s) of the drug is then diluted with 5% dextrose or 0.9% sodium chloride injection to a volume appropriate for the infusion apparatus to be used. The administration of floxuridine is best achieved with the use of an appropriate pump to overcome pressure in large arteries and to ensure a uniform rate of infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. The recommended therapeutic dosage schedule of floxuridine by continuous arterial infusion is 0.1 to 0.6 mg/kg/day. The higher dosage ranges (0.4 to 0.6 mg) are usually employed for hepatic artery infusion because the liver metabolizes the drug, thus reducing the potential for systemic toxicity. Therapy can be given until adverse reactions appear. (See PRECAUTIONS section.) When these side effects have subsided, therapy may be resumed. The patient should be maintained on therapy as long as response to floxuridine continues. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. 1-7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
Read the full Dosage and Administration section on DailyMed →
Floxuridine side effects
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Common side effects
- Nausea
- Vomiting
- Diarrhea
- Enteritis (inflamed intestines)
- Stomatitis (mouth sores)
- Localized redness of the skin
- Low blood counts (anemia, low white cells, low platelets)
- Abnormal liver blood tests
When to get medical help
- Call your care team right away about severe nausea, vomiting or diarrhea, or any bleeding.
- Report signs of infection, including fever, or any redness, pain, bleeding or leaking at the catheter site.
- Tell them about chest pain, which may signal reduced blood flow to the heart.
- Report severe stomach pain or ulcer symptoms.
- Report symptoms of arterial problems or blood clots from the infusion procedure, such as new pain, swelling or coldness in the affected area.
- Tell your team about any unusual weakness, lethargy or feeling very unwell.
Many side effects relate to the digestive system, blood counts and the infusion procedure itself.
- Nausea, vomiting and diarrhea
- Enteritis and mouth sores
- Localized redness
- Anemia, low white blood cells and low platelets
- Raised liver tests
Serious problems can include stomach ulcers and bleeding, heart blood-flow problems, liver damage, and arterial clots or catheter infection or bleeding. Report these promptly.
Floxuridine warnings and precautions
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- Severe toxic reactions are possible, so the first course is given in the hospital.
- It should be given only under a physician experienced in cancer chemotherapy and intra-arterial therapy.
- Use extreme caution with liver or kidney impairment, prior high-dose pelvic radiation or previous alkylating agents.
- It may harm an unborn baby.
- Treatments that stress the body, affect nutrition or lower bone marrow function increase toxicity.
Floxuridine interactions
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The label points to combination therapy concerns.
- Any therapy that adds stress to the body can increase toxicity.
- Therapy that interferes with nutrition can increase toxicity.
- Therapy that depresses bone marrow function can increase toxicity.
Interactions listed in the FDA-approved label
From the Floxuridine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
Drug Interactions See WARNINGS section.
Read the label’s full interactions text
Drug Interactions See WARNINGS section.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Floxuridine
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- Not for people in a poor nutritional state.
- Not for people with depressed bone marrow function.
- Not for people with potentially serious infections.
- Use extreme caution with liver or kidney problems.
- Tell your doctor about prior pelvic radiation or alkylating agent chemotherapy.
- Tell your doctor if you are pregnant or could become pregnant.
Floxuridine overdose
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Overdose is unlikely given how floxuridine is given. If it happens, expect nausea, vomiting, diarrhea, stomach ulcers and bleeding, and bone marrow suppression. There is no specific antidote, and blood counts should be monitored for at least 4 weeks.
What Floxuridine does in the body
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Floxuridine interferes with making DNA and, less so, RNA. Given by continuous infusion, it is more directly converted to a form that increases DNA inhibition. Rapid injection produces the same toxic and antimetabolic effects as 5-fluorouracil.
How your body processes Floxuridine
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Floxuridine is broken down in the liver. It is cleared in urine as the intact drug and several breakdown products, and some leaves the body as carbon dioxide in the breath. Rapid injection is quickly converted to 5-fluorouracil.
How to store Floxuridine
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stored at 20° to 25°C (68° to 77°F) . stored under refrigeration 2° to 8°C (36° to 46°F) for not more than 2 weeks.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Floxuridine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Floxuridine — the kind of thing our pharmacy team would talk through with you at the counter.
What is floxuridine for?
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Why do I have to be in the hospital at first?
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How is it given?
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What side effects should I expect?
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Can I use it if I am pregnant?
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Who should not get floxuridine?
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Is Floxuridine available over the counter?
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When was Floxuridine first available?
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Who makes Floxuridine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Floxuridine on HelloPharmacist
Floxuridine forms and strengths (how it comes)
Floxuridine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Floxuridine for Injection is used for palliative management of gastrointestinal adenocarcinoma that has spread to the liver, given by continuous regional intra-arterial infusion in carefully selected patients.
- Floxuridine for Injection comes as a powder that is mixed with sterile water, then diluted before infusion.
- Floxuridine is best given with an appropriate pump to give a steady infusion rate.
- Floxuridine is given into an artery, and the first course should be given in the hospital.
Floxuridine on the U.S. market: products, makers and brands
How Floxuridine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
5 companies list 7 Floxuridine product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 1970. Brand names on the directory include Fudr; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Compare Floxuridine products
A representative set of FDA-listed product records for Floxuridine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 500 mg | Intra-arterial | Cerona Therapeutics, Inc. | ANDA | View NDC → |
| 500 mg/5 mL | Intra-arterial | Fresenius Kabi USA, LLC × 2 listings | ANDA | View NDC → |
| 100 mg/mL | Intra-arterial | Hikma Pharmaceuticals USA Inc. × 2 listings | ANDA | View NDC → |
| 500 mg | Intra-arterial | JND Therapeutics, Inc. | ANDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 g/g | — | Zhejiang ChemPacific Corporation | BULK INGREDIENT | View NDC → |
Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Floxuridine NDCs →
Floxuridine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Floxuridine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Floxuridine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Floxuridine FDA approval history
How Floxuridine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Floxuridine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Floxuridine recalls since July 2021.
✅No Floxuridine recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 4488 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 1729194In current FDA listingsClinical drug / strength (SCD) 500 MGRxCUI 310351
Look up RxCUI 4488 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Floxuridine supply and shortage status
Whether Floxuridine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Floxuridine brand names
Floxuridine is sold under one brand name in the FDA directory — Fudr. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Floxuridine: manufacturers and labelers
5 companies list Floxuridine products with the FDA. By number of product records, the largest are Fresenius Kabi USA, LLC, Hikma Pharmaceuticals USA Inc., Cerona Therapeutics, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Floxuridine drug class (RxNorm)
Floxuridine belongs to the Antimetabolite class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Floxuridine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Hikma Pharmaceuticals USA Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →