FUDR

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FUDR

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of FUDR

Property Description
Active ingredient Floxuridine (5-fluoro-2'-deoxyuridine)
Form Sterile powder for reconstitution / Solution for injection
Pharmacological class Antineoplastic agent, Antimetabolite
General purpose Suppression of malignant cell growth
Origin Synthetic

What Type of Medicine is Floxuridine (FUDR)?

Floxuridine (often known as FUDR) is a potent, synthetic pharmaceutical compound categorized as an antineoplastic agent, specifically designed to combat malignant neoplasms (cancer). It belongs to the specialized antimetabolite class of chemotherapy drugs, acting as a structural member of the fluorinated pyrimidine analog family. This classification signifies that the drug is engineered to interfere with fundamental cellular growth processes. The high potency of Floxuridine's mechanism is clinically recognized for its utility in regional treatment strategies, differentiating its application profile from more broadly systemic agents.


Composition and Pharmaceutical Form of Floxuridine

Floxuridine is a prescription-only, single-ingredient product where the sole active ingredient is Floxuridine itself. This medication is supplied in a form strictly designed for administration into the body’s circulation, most commonly as a sterile powder for reconstitution or an established solution for injection/infusion. It is designated as a parenteral preparation because it must be administered directly, bypassing the digestive system, a delivery approach required to ensure its direct systemic availability. Its specialized form facilitates regional arterial infusion, a characteristic administration method for delivering high concentrations locally to the site of the tumor.


General Purpose and Mechanism Principle

The general purpose of Floxuridine is to suppress the uncontrolled growth and proliferation of cancer cells by interrupting their genetic machinery. Its function as an antimetabolite involves mimicking a natural cellular building block; this action leads to the subsequent blocking of a critical enzyme required for DNA synthesis. Floxuridine acts as a potent inhibitor of thymidylate synthase, providing a means to halt cell division. The drug’s core benefit is its ability to prevent malignant cells from successfully copying their DNA and dividing, which is fundamental to controlling the progression of the disease.

Regulatory References

  1. U.S. Food and Drug Administration
  2. National Institutes of Health
  3. NIH NCI Drug Dictionary: Floxuridine

What side effects are possible with FUDR?

Possible Side Effects and Safety Information

FUDR (floxuridine) is a highly potent medication with a narrow margin of safety, meaning that therapeutic response is often accompanied by signs of toxicity. Patients beginning treatment are generally hospitalized for careful supervision of the first course.

Serious and Clinically Significant Adverse Reactions

The most serious risks involve severe bone marrow suppression (myelosuppression), leading to low white blood cell counts (leukopenia), low platelet counts (thrombocytopenia), and anemia, which can cause severe infection or bleeding. Gastrointestinal toxicity is also a major concern, including severe diarrhea, stomatitis (mouth sores), esophagopharyngitis, and gastrointestinal ulceration/bleeding. Less frequent but serious events include myocardial ischemia (reduced blood flow to the heart) and neurological toxicity (e.g., acute cerebellar syndrome, confusion).

Signs of severe toxicity require prompt discontinuation or dose modification of the drug.

Common and Less Common Side Effects

Common effects include diarrhea, sores in the mouth and on the lips, and stomach pain/cramps. Less common effects include nausea, vomiting, loss of appetite, heartburn, temporary hair thinning (alopecia), and hand-foot syndrome (scaling or redness of hands or feet). Delayed effects, occurring months or years after use, may include an increased risk of certain cancers, such as leukemia.

Safety Considerations and Contraindications

Dihydropyrimidine Dehydrogenase (DPD) Deficiency: Individuals with a complete deficiency of the DPD enzyme are at high risk for acute, life-threatening or fatal toxicity and are generally not recommended to receive this drug. Those with partial DPD deficiency may also be at increased risk. Healthcare providers may consider DPD testing prior to treatment.

Contraindications also include poor nutritional status, pre-existing myelosuppression, and known hypersensitivity. The drug is considered a fetal hazard; therefore, effective contraception is required during and for a specified period after therapy for both men and women. Due to the unknown potential for harm, breastfeeding is not recommended during treatment.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Floxuridine (FUDR) describes specific anticipated manifestations following overexposure. The documented clinical and physiological findings primarily affect two major organ systems, indicating the potential severity of an overdose situation.

Documented Manifestations and Actions

Classification Regulatory Statement
Documented Target Organ Toxicity Gastrointestinal effects including nausea, vomiting, diarrhea, gastrointestinal ulceration, and gastrointestinal bleeding.
Hematological Effects Bone marrow depression, including thrombocytopenia, leukopenia, and agranulocytosis, is an anticipated physiological finding.
Emergency Action Required Individuals must seek immediate medical attention or contact a Poison Control center if overexposure is suspected.
Antidote Status No specific antidotal therapy exists for Floxuridine overdosage.

Post-Overdose Monitoring

Due to the severity of the expected hematological effects, patients exposed to an overdosage of Floxuridine are required to be monitored hematologically for at least four weeks. This mandatory monitoring procedure is detailed in the official prescribing information. The absence of a specific antidote necessitates that management be symptomatic and supportive, focusing on the acute toxicities observed.

Therapeutic Uses of FUDR

Quick Facts

  • FUDR is a medicine used to address certain forms of cancer.
  • It provides a therapeutic option for tumors originating in the digestive tract that have spread to the liver (hepatic metastases).
  • The use is specifically for the palliative management of these advanced conditions.

What FUDR Treats: Main Uses and Benefits

FUDR (Floxuridine) is a prescription medicine utilized in oncology to address certain malignant conditions. The main use is in the palliative management of gastrointestinal adenocarcinoma that has spread to the liver, known as hepatic metastases. Palliative management is focused on helping to alleviate the severity of symptoms and supporting the quality of life in advanced stages of disease. FUDR is generally administered via continuous regional intra-arterial infusion in carefully selected patients who may not have other surgical options available.

This treatment regimen works to interfere with the cellular processes that support the proliferation of cancer cells in the affected area. The therapeutic goal is to help stabilize the condition and support the patient's well-being.

Regulatory References

  1. NIH DailyMed guidance

Eligibility and Restrictions for Use

Official Eligibility Profile for Floxuridine (FUDR)

Allowed and Contraindicated Populations

Floxuridine is approved for use in adult patients for the palliative management of gastrointestinal adenocarcinoma that has spread to the liver. Regulatory labeling classifies the drug as absolutely contraindicated for several populations. These groups must not receive the medicine and include patients with depressed bone marrow function, those in a poor nutritional state, or individuals with potentially serious infections.

Age and Reproductive Status

Use is not established in pediatric patients, as safety and efficacy data are insufficient for this age group. For reproductive health, the drug is formally contraindicated in pregnancy (Category D) due to the documented risk of fetal harm, and discontinuation of nursing is required during treatment.

Conditional Use and Restrictions

The medicine is required to be used with extreme caution in patients with pre-existing impaired hepatic function or impaired renal function. This conditional use also extends to individuals with a history of high-dose pelvic irradiation or previous use of alkylating agents.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section summarizes information from official government regulatory documents regarding the known interactions of FUDR (Floxuridine) with other substances.


Potential Pharmacodynamic Interactions

Official regulatory information highlights interactions that involve an increased risk of specific toxic effects when FUDR is combined with certain agents.

Interaction Domain Relevant Drug Categories Regulatory Action Classification
Increased QT Interval Risk Medicinal products known to prolong the QTc interval (e.g., Amiodarone, Methadone, Dronedarone). Major/Moderate: Monitor closely or avoid combination.
Increased Immunosuppression Other immunosuppressive therapies (e.g., Belatacept, Fingolimod, Denosumab). Moderate: Monitor closely for increased risk of infection.
Vaccine Interference Live or inactivated vaccines (e.g., Cholera, Dengue, Influenza). Moderate/Minor: Decreased effect of the vaccine due to FUDR's immunosuppressive activity.

Other Documented Interactions

FUDR may also affect the levels of other medications. For example, the combination of FUDR and Fosphenytoin may result in an increase in Fosphenytoin levels. The official profile requires caution and close monitoring for patients receiving these combinations. No explicit timing or separation requirements are documented in the official regulatory labels for co-administration of FUDR with food or herbal products.

Mechanism of Action

The mechanism of Floxuridine (FUDR) is a cell-cycle specific antimetabolite action that intervenes directly in the processes required for cell division, operating strictly within the molecular domain. It acts on the fundamental metabolic pathways required for genetic material assembly, rather than on neurological receptors or inflammatory mediators.

Irreversible Blockade of DNA Precursor Synthesis

Floxuridine's core action involves its intracellular conversion to the active metabolite, FdUMP, which forms a stable, inhibitory complex with the enzyme Thymidylate Synthase (TS) . This interaction immediately prevents the cell from producing dTMP, a building block essential for DNA synthesis and repair. The resulting physiological consequence is the functional starvation of rapidly dividing cells, which cannot proceed through the S-phase (Synthesis phase) of their cycle.

Disruption of Nucleic Acid Integrity and Apoptosis

Beyond precursor depletion, other active metabolites are incorporated directly into both newly forming DNA and RNA strands. This structural contamination results in defective genetic material, which induces profound genomic stress. The failure of the cell to cope with this damaged machinery forces the rapid initiation of apoptosis (programmed cell death), a mechanism that results in the suppression of proliferative tissue growth.

Dosage and Administration Information

FUDR (floxuridine) is a specialized cancer medication that must be administered only by healthcare professionals experienced in cancer chemotherapy and intra-arterial drug delivery.

Administration Method and Setting

The approved route of administration is by continuous regional intra-arterial infusion, often into the hepatic artery. The medication is given via an indwelling catheter, frequently utilizing an appropriate pump to ensure a uniform rate of delivery. All patients are required to be hospitalized for the initiation of the first course of therapy due to the possibility of severe adverse reactions.

Dosing and Preparation

The dosage is typically administered as a continuous daily infusion, with ranges generally spanning 0.1 to 0.6 mg per kg of body weight per day. For infusion into the hepatic artery, doses often fall within the higher range of 0.4 to 0.6 mg/kg/day.

Before administration, the drug must be prepared through two main steps:

  1. Reconstitution: The vial containing 500 mg of floxuridine powder is first reconstituted with 5 mL of Sterile Water for Injection.
  2. Dilution: The calculated daily dose must then be further diluted with a parenteral solution, such as 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP, to a final volume suitable for the infusion device.

Duration of Therapy

Therapy should be continued as long as the patient responds to treatment. If adverse reactions occur, therapy may be interrupted and then resumed after the reactions have subsided. The safety and effectiveness of this medication have not been established in patients under 18 years of age.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Floxuridine (FUDR)

Evidence for Use in Palliative Treatment of Colorectal Liver Metastases

Research has examined the use of Floxuridine (FUDR) for colorectal cancer that has spread to the liver. The evidence base includes historical Randomized Controlled Trials (RCTs) and meta-analyses that evaluated outcomes when administered via hepatic arterial infusion (HAI) and compared these to outcomes measured when administered via systemic (intravenous) chemotherapy or observation. Studies monitored primary outcomes like Overall Survival (OS) and Progression-Free Survival (PFS). Trials reported measurements of tumor shrinkage or stabilization in the liver, and patterns related to these measurements were observed when compared against systemic therapies alone. Early research observed various patterns in survival outcomes, though comprehensive meta-analyses indicate that the findings regarding a definitive difference were mixed. Recent research explores FUDR in combination with current systemic treatments, and these studies monitored outcomes to measure local tumor control. The complexity of the HAI technique has also been documented as a factor limiting the extent of its study. Long-term effects are not fully established.

Evidence for Use Following Surgical Removal of Liver Metastases (Adjuvant Setting)

Research was studied for the use of FUDR delivered via the HAI route following complete surgical removal (resection) of colorectal liver metastases. These investigations included RCTs designed to evaluate whether the addition of FUDR to post-operative treatment plans was associated with changes in outcomes. Research examined Relapse-Free Survival (RFS) and Overall Survival (OS), specifically focusing on patterns related to the rate of cancer recurrence in the remnant liver. Findings regarding RFS and OS, however, were mixed; some trials were terminated early based on predefined criteria related to study progress. Research explored whether outcomes varied in patient groups defined by higher disease burden or specific molecular markers.

Key Studies & References

  1. The role of hepatic arterial infusion chemotherapy in the management of colorectal cancer liver metastases (Review)

Frequently Asked Questions (FAQ)

Common questions about FUDR (FAQ)


Q: How is FUDR different from other medicines that treat similar illnesses?

FUDR (floxuridine) is classified as a fluorinated pyrimidine antimetabolite. Official product information notes that the drug’s specialized utility is recognized for use in regional treatment strategies via continuous intra-arterial infusion. This administration method is distinct from certain other cancer medicines given systemically.


Q: Do the common side effects of FUDR usually lessen or go away over time?

Regulatory documents indicate that for some effects, such as temporary hair thinning (alopecia), the effect is usually transient (temporary). If signs of severe toxicity—like severe mouth sores or very low white blood cell counts—appear, the treatment regimen is typically interrupted or discontinued by the healthcare provider.


Q: Does FUDR interact with common over-the-counter pain relievers like ibuprofen or Tylenol?

Official product information indicates that certain over-the-counter medications, including NSAIDs (like ibuprofen) and acetaminophen (Tylenol), may be associated with documented interactions. Individuals are advised to always review all medications and supplements with their medical team.


Q: Is FUDR a medication that is meant to be used for a short time or long-term?

FUDR is indicated for the palliative management of metastatic cancer, defining its therapeutic goal. The duration of therapy is not fixed; instead, it may be continued as long as the patient is responding to the treatment, which is determined clinically.


Q: Are there specific vitamins, minerals, or herbal supplements that are known to interact with FUDR?

Official regulatory compilations note that minor interactions have been found with certain supplements, including Vitamins A and E, maitake, and taurine. Individuals should inform their prescribing healthcare team about all supplements they may be using.


Q: Is it normal to experience fatigue or nausea when starting treatment with FUDR?

Nausea is listed in official documents as a common adverse reaction to this medicine. Furthermore, fatigue can be an indirect effect associated with anemia (a low red blood cell count), which is a common laboratory abnormality seen with FUDR use.


Q: Can people with certain pre-existing heart conditions use FUDR?

Official warnings state that a serious adverse reaction is the risk of myocardial ischemia (reduced blood flow to the heart) during treatment, which requires the drug to be promptly discontinued. Individuals with pre-existing heart conditions should be reviewed for treatment suitability with extreme caution.


Q: Is the administration method for FUDR (e.g., injection, infusion) common for this type of drug?

The approved administration of FUDR is by continuous regional intra-arterial infusion (into the artery serving the tumor). This method is a specialized approach recognized for regional treatment strategies, distinguishing it from common systemic intravenous administrations.


Q: Are there ongoing clinical trials exploring new potential uses for FUDR?

Yes, the official regulatory databases, such as ClinicalTrials.gov, contain records showing ongoing research into the use of floxuridine. This research is often focused on using the drug in combination with current systemic treatments for various cancer types.


Q: What is the difference between the brand name FUDR and its generic version?

The brand name for this medicine is FUDR®, and its active chemical ingredient is floxuridine. Official documentation confirms that the active ingredient, floxuridine, is also available generically as a sterile powder or solution for injection/infusion.


Q: Does FUDR carry a high risk of causing allergic reactions?

The official product information lists known hypersensitivity (a severe allergic reaction) as an absolute contraindication for FUDR use. This classification means the medicine is not suitable for administration to patients who have a confirmed allergy to it.


Q: Does body weight influence the standard eligibility for using FUDR?

While the dosage is calculated based on the patient's body weight (milligrams per kilogram), a patient’s weight alone does not determine eligibility. The official criteria for contraindications (who cannot use the medicine) are based primarily on factors like bone marrow function, nutritional status, and the presence of severe infections.


Q: Can FUDR be used safely by older adults or senior patients?

Patient information compiled from regulatory documents indicates that there is no specific data comparing the use of the drug in older adults to younger adults. However, the medicine is not generally expected to cause different side effects or problems in senior patients than in other adult age groups.


Q: Is FUDR considered a standard first-line treatment for the approved use?

The drug is indicated for the palliative management of metastatic cancer, defining its specialized therapeutic role. Official regulatory documents indicate its use in carefully selected patients who are generally considered incurable by surgery or other means (as indicated in regulatory documents).


Q: Does FUDR affect a person's ability to drive or operate machinery?

Official warnings state that the drug can cause neurological toxicity, which includes effects like confusion and acute cerebellar syndrome. Due to the possibility of severe toxicity, performing tasks that require mental alertness, such as driving or operating machinery, may be impaired.


Q: What should a person expect in the first week of starting FUDR treatment?

Official regulatory warnings indicate that due to the possibility of severe toxic reactions, patients are typically hospitalized for the initiation of the first course of therapy. This is done to ensure close supervision and monitoring for any severe adverse reactions.


Q: What happens if a person stops using FUDR suddenly?

The prescribing information indicates that therapy is discontinued promptly by a healthcare provider if certain signs of severe toxicity, such as severe gastrointestinal issues or very low white blood cell counts, are observed. Changes to the treatment plan should only be made under medical guidance.


Q: Are there any known food or drink items that should be avoided while using FUDR?

According to patient information compiled from regulatory sources, there are no known interactions between floxuridine and ordinary foods or drinks. The drug may be used without mandatory timing or separation requirements related to meals.


Q: Does alcohol interact with FUDR and what is the typical caution given?

While official regulatory information does not document a specific, direct interaction with alcohol, patient information may suggest limiting its use. This is primarily because alcohol can potentially slow the immune response and increase the risk of bleeding, particularly when combined with a cytotoxic drug.


Q: Is it required to have routine blood tests while using FUDR?

Yes, the official laboratory test section recommends careful monitoring of the white blood cell count and platelet count. This is due to the drug's high toxicity and risk of causing severe hematological toxicity (problems affecting the blood), which can lead to infection or bleeding.


Q: What is the general expectation for treatment success described in official studies?

The general expectation is aligned with the drug's purpose: it is intended for palliative management. Official studies monitored outcomes related to survival (Overall Survival) and disease progression (Progression-Free Survival), with findings regarding definitive differences often noted as mixed.

How should FUDR be stored and disposed of?

How to Store and Dispose of FUDR?

Floxuridine (FUDR) is a sterile powder requiring strict storage and handling as an antineoplastic agent.

Unopened Powder Storage: The unopened sterile powder must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F), with permitted temperature excursions. The container must be kept tightly closed and protected from light and moisture.

Stability and Reconstituted Solution: Once reconstituted, the solution must be stored under refrigeration (2 C to 8 C / 36 F to 46 F) and is stable for not more than 2 weeks.

Handling and Disposal: As a cytotoxic drug, proper handling procedures for anticancer agents must be considered, including adherence to established guidelines. Disposal of unused product and waste must follow local regulations and official instructions to prevent environmental contamination, particularly avoiding soil, drains, and water courses.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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