Ufur

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Ufur

Treatment option: Colorectal Cancer, Cancer

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Ufur

Quick Facts

Property Description
Active Ingredients Tegafur and Uracil
Form Oral Chemotherapeutic Agent (Tablet/Capsule)
Pharmacological Class Antimetabolite, Fluoropyrimidine Analogue
General Purpose Systemic Anti-Cancer Therapy
Origin Synthetic Combination Product

Ufur: Definition and Classification as a Fixed-Dose Combination

Ufur is a prescription-only, oral antineoplastic agent used in anti-cancer therapy. Pharmacologically, it is a synthetic compound classified as an antimetabolite within the class of pyrimidine analogues. The use of this combination is clinically recognized for its role in suppressing the proliferation of malignant cell populations. This medicine is defined as a fixed-dose combination product because it contains two distinct active pharmaceutical ingredients combined into a single oral formulation, intended for systemic delivery against cell proliferation.

What is Ufur Made of? The Tegafur-Uracil Composition

Ufur is primarily composed of the active ingredients Tegafur and Uracil, which are typically formulated in a specific 1:4 molar ratio (Tegafur:Uracil). Tegafur functions as the inactive prodrug, which the body must convert into the active therapeutic agent, fluorouracil (5-FU). Conversely, Uracil is a non-cytotoxic compound included to serve as a biochemical modulator. This synergistic combination is a core differentiating factor of the formulation, ensuring a controlled and active pharmacological presence.

How Ufur Differs as an Oral Chemotherapeutic Agent

Ufur is an oral chemotherapeutic agent, signifying that its route of administration is through the mouth, providing a key advantage of convenience over intravenous requirements associated with other treatments. The inclusion of Uracil is the defining characteristic, as it acts as an inhibitor of the enzyme dihydropyrimidine dehydrogenase (DPD). This mechanism ensures the maintenance of high, sustained systemic availability of the compound, contributing to controlled and extended exposure for therapeutic benefit.

What side effects are possible with Ufur?

Serious Side Effects and Safety Limitations

Ufur (active ingredient Fluorouracil) is associated with several serious, potentially fatal adverse reactions documented in official regulatory labeling. These reactions typically involve major organ systems and may necessitate immediate withholding or permanent discontinuation of the drug.

System Organ Class Serious/Clinically Significant Adverse Reactions
Hemic & Lymphatic Severe and fatal myelosuppression (low blood counts)
Cardiovascular Cardiotoxicity (e.g., angina, myocardial infarction, heart failure)
Gastrointestinal Severe mucositis (sore mouth/GI tract) and severe diarrhea
Nervous System Acute cerebellar syndrome, confusion, ataxia, and Hyperammonemic Encephalopathy
Dermatologic Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome)

Population-Specific Safety Considerations (DPD Deficiency)

Patients who have a complete or near-complete lack of the Dihydropyrimidine Dehydrogenase (DPD) enzyme, due to specific DPYD gene variants, are at a significantly increased risk for acute, early-onset, and potentially fatal toxicities, including severe mucositis, neutropenia, and neurotoxicity. Ufur is not recommended for use in patients known to have DPD deficiency resulting in a complete absence of enzyme activity. Due to the risk of embryofetal toxicity, Ufur can cause harm to a fetus and is a safety consideration for both females and males of reproductive potential.

Overdose and Emergency Response

Overdose with Ufur (Tegafur and Uracil) results in severe systemic toxicity from the active metabolite, fluorouracil (5-FU), as documented in official regulatory prescribing information. Overexposure may manifest as life-threatening gastrointestinal, hematological, and cardiac events.

Documented manifestations of overexposure include severe diarrhea and mucositis, profound and prolonged myelosuppression (leading to severe neutropenia and other cytopenias), and neurological signs such as confusion and ataxia. The official profile also lists serious outcomes, including acute cardiotoxicity like myocardial ischemia, hyperammonemic encephalopathy, and subsequent septic shock, all of which may be fatal. Patients with Dihydropyrimidine Dehydrogenase (DPD) deficiency are officially noted as a population at significantly increased risk for severe or fatal toxicity following overexposure.

Required Emergency Action Regulatory authorities explicitly state that any known overdose or the appearance of severe toxicity requires the user to seek immediate medical attention or contact emergency services immediately. Hospitalization for observation and supportive treatment is necessary. The management of overexposure includes continuous, prolonged monitoring of laboratory parameters (such as a Complete Blood Count for up to four weeks) and the regulated emergency administration of the specific antidote, uridine triacetate.

Therapeutic Uses of Ufur

What Ufur Treats: Main Uses and Benefits

Ufur is commonly used for managing several major solid tumors, focusing primarily on the gastrointestinal tract, including colorectal cancer and advanced gastric cancer. Clinical investigations support its use in therapeutic approaches aimed at controlling the disease. It is applied in addressing conditions marked by increased physiological stress, providing systemic treatment that is used for managing conditions characterized by periods of heightened symptoms.

Ufur is commonly used as adjuvant chemotherapy following the surgical removal of the tumor, particularly for patients with Stage II and Stage III colorectal cancer. This treatment context is relevant for managing symptoms that interfere with daily comfort and is applied in contexts marked by increased discomfort or tension related to the underlying condition. The therapy supports the patient during difficult episodes by easing distress. A key practical benefit is its oral formulation, which is applicable within therapeutic areas involving heightened responses and assists with maintaining functional stability.

“The oral dosing of this compound is generally considered relevant for patients who require long-term continuous therapy outside of an acute hospital setting.”

Quick Fact: Supportive Relief for Systemic Symptom Burden Ufur is relevant for easing the overall symptomatic burden associated with disease progression and helps maintain stability when symptoms are more noticeable.

Regulatory References

  1. Study Details: Adjuvant Tegafur-Uracil for Colon Cancer

Eligibility and Restrictions for Use

Ufur, a combination of tegafur and uracil (UFT), is a chemotherapy agent used in the treatment of various cancers, most commonly metastatic colorectal cancer, often in combination with calcium folinate. It is typically prescribed to adults, and the decision to use it is based on a thorough medical evaluation by a qualified healthcare professional.


Who Can Use Ufur?

Ufur is generally indicated for adult patients with certain types of cancer. It is used in situations where the benefit of the treatment is considered to outweigh the risks. Before starting treatment, patients undergo assessments to ensure adequate liver, kidney, and bone marrow function.


Who Cannot Use Ufur? (Contraindications)

The use of Ufur is contraindicated (should be avoided) in several specific patient groups due to the high risk of serious adverse effects or harm. Patients should not receive Ufur if they have a history of:

  • Known severe allergy or hypersensitivity to tegafur, uracil, or any component of the drug.
  • Severe liver disease or significant liver dysfunction.
  • Severe kidney disease.
  • Dihydropyrimidine Dehydrogenase (DPD) deficiency, an inherited condition that impairs the metabolism of the active drug component, leading to potentially fatal toxicity.
  • Severe bone marrow suppression (low blood cell counts).
  • Pregnancy or breastfeeding, as the drug is known to pose a risk to the fetus and infant.
  • Children under 18 years of age, as its safety and efficacy have not been established in the pediatric population.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation structures the interaction profile of Ufur (Tegafur and Uracil) around the metabolism of its active component, 5-fluorouracil (5-FU).

Contraindicated Combinations

Co-administration with Sorivudine and related DPD inactivating antiviral nucleosides is strictly prohibited. This combination results in the irreversible inactivation of the Dihydropyrimidine Dehydrogenase (DPD) enzyme, which formally leads to a massive, potentially fatal increase in the systemic exposure of 5-FU.

Documented Exposure-Altering Interactions

Interaction Partner Official Outcome Description
Coumarin Anticoagulants (e.g., Warfarin) Associated with an increased International Normalized Ratio (INR) or prolonged prothrombin time (pharmacodynamic interaction).
CYP2A6 Inhibitors/Inducers Formal potential to alter 5-FU plasma concentrations (pharmacokinetic interaction).

Population-Specific Interaction Notes

Patients with a known DPYD enzyme deficiency are recognized in official labeling as a critical population. Due to genetically reduced clearance of 5-FU, standard dosing results in a severe, potentially fatal toxic exposure. This necessitates mandatory procedural constraints regarding metabolic status.

Administration Requirements

Regulatory documents establish a mandatory administration timing rule relative to food to ensure predictable and consistent systemic exposure.

Mechanism of Action

Tegafur's Molecular Action: Irreversible Enzymatic Inhibition

The mechanism begins with the prodrug Tegafur, which is converted into the active anti-metabolite, 5-Fluorouracil (5-FU). This active agent is then anabolized into the inhibitory metabolite FdUMP, which forms a stable complex with the enzyme Thymidylate Synthase (TS). By blocking TS, the drug prevents the production of dTMP, a necessary precursor for DNA synthesis. This molecular resource depletion creates a "thymineless state" in the cell, initiating a cascade of damage and depletion that leads to programmed cell death (apoptosis).

Dual Mechanism: Disruption of DNA and RNA Integrity

Beyond enzyme inhibition, 5-FU is also metabolized into FUTP, which is mistakenly incorporated directly into the cell's RNA. This causes structural errors that render the cell's protein-making machinery functionally defective. This dual mechanism compounds the cellular stress, resulting in an enhanced anti-proliferative physiological effect.

Uracil's Role: Strategic Biochemical Modulation

The compound Uracil is included as a competitive inhibitor of Dihydropyrimidine Dehydrogenase (DPD), the enzyme responsible for inactivating 5-FU. By reducing 5-FU clearance, Uracil increases the overall concentration and duration of the active agent at the site of action, ensuring a more sustained and concentrated inhibition of the cellular targets. The resulting physiological effect is an enhancement of the anti-proliferative mechanism.

Dosage and Administration Information

Ufur is an oral antineoplastic agent that is always administered in a cyclic pattern, with dosing calculated specifically for each patient. The medicine is supplied as a fixed-dose capsule containing Tegafur and Uracil in a 1:4 molar ratio.

Administration Protocol

The dose is based on the patient’s Body Surface Area (BSA) and expressed by its Tegafur component. A standard daily dose used in documented clinical regimens is 300 mg/m² per day.

The total daily dose must be divided into multiple administrations—typically two or three separate doses—taken throughout the day. A critical procedural step is the timing of ingestion: the doses should be taken with water, specifically avoiding the interval of one hour before and one hour after meals. The capsules should be swallowed whole.

Use Over Time and Special Conditions

Administration follows a defined regimen of treatment cycles. A common cycle involves 28 consecutive days of oral dosing followed by a 7-day rest period, completing a 35-day cycle. Total treatment duration for adjuvant therapy is often administered for a six-month period.

If a scheduled dose is missed or vomited, it is specified that the dose should not be replaced; treatment should simply resume with the next scheduled administration. The BSA calculation ensures appropriate dosing across all adult patient populations, including older adults.

Recent Clinical Evidence

Research Evidence / Overview of studies for Ufur (Tegafur-Uracil)


Evidence for use in Colorectal Cancer

Research examining the use of Ufur for colorectal cancer primarily comes from many large, official Phase III Randomized Controlled Trials (RCTs). These studies were evaluated in adult patients with Stage II and Stage III colorectal cancer who had a complete surgical removal of their primary tumor. The research examined long-term outcomes such as whether patients remained cancer-free (Disease-Free Survival) and how long patients lived (Overall Survival) over periods spanning five years or more. Studies were observed in comparison to observation (surgery alone) or other fluoropyrimidine-based standard regimens.

Findings describe patterns where long-term survival was closely monitored. Research examined the data in comparison to other regimens. Data show patterns related to the specific design of the study, and some trials explored whether the outcomes measured were similar to those observed in the standard regimens. For patients with metastatic colorectal cancer (cancer that has spread), research examined Ufur in combination with other anti-cancer agents, focusing on how often tumors shrank (Objective Tumor Response Rate) and how long patients lived overall.

What remains uncertain is the consistency of the evidence for every single patient group. This includes those with lower-risk Stage II disease, where research explored whether a statistically significant difference in survival was observed compared to surgery alone. Also, the literature notes that results apply only to the populations studied, and long-term effects are not fully established.


Evidence for use in Gastric Cancer

Ufur was studied for use in patients with gastric (stomach) cancer, primarily in two distinct research scenarios: adjuvant studies (post-surgery) and studies for advanced or metastatic disease. Post-operative trials focused on tracking Disease-Free Survival and Overall Survival. The advanced disease research was applied in studies examining patient-reported experiences and studies monitored Overall Survival and the Objective Tumor Response Rate.

Studies observed patterns related to survival rates when Ufur was used post-surgery, with the reported outcomes often depending on the specific type and extent of the surgery the patient underwent. Research exploring short-term symptom changes in the advanced disease setting was also evaluated in studies.

The generalizability of these findings remains limited, as results apply only to the populations studied. Furthermore, the certainty remains low in some advanced disease settings where trials had modest sample sizes or where long-term outcomes are not fully established.

Frequently Asked Questions (FAQ)

Common questions about Ufur (FAQ)

Q: How long does it typically take to start feeling the effects of Ufur?

Studies and official information indicate that the amount of time required for the medicine to show its full therapeutic anti-cancer action is generally not clinically established in available documentation. The time it takes for a chemotherapy drug to start affecting malignant cells can vary significantly among individuals.


Q: Does Ufur have a long-lasting effect, or is it short-term?

Official information indicates that the duration of the drug’s overall clinical effect is not fully established. Pharmacological studies observe that the active component, 5-fluorouracil, remains detectable in the bloodstream for the typical dosing interval, meaning it is pharmacologically designed to maintain a sustained presence for therapeutic benefit, according to the treatment plan.


Q: Is Ufur similar to [Commonly known drug name]?

Ufur is a combination product that includes the prodrug Tegafur, which the body must convert into the active chemotherapy agent, 5-fluorouracil (5-FU). Because of this action, the medicine is classified as a fluoropyrimidine analogue and is pharmacologically related to other treatments in this class.


Q: Can Ufur cause weight gain or weight loss?

Adverse events noted in clinical experience include a decreased appetite and weight loss. Weight gain is not established as a commonly reported adverse effect in the official product information.


Q: Does Ufur affect sleep patterns?

Official documentation does not typically list specific changes to sleep patterns. However, the medicine is associated with common side effects such as asthenia or fatigue. Any significant changes in neurological status, including sleep, are often monitored by a healthcare provider.


Q: Is it common to feel tired when taking Ufur?

Yes, asthenia (a lack of energy or physical strength) or fatigue is listed among the most common adverse reactions reported in clinical trials for Ufur. Patients are advised to be aware of this potential effect during their treatment cycle.


Q: Are there any specific foods or drinks that should be avoided while using Ufur?

Official guidance emphasizes the mandatory timing rule, which is to avoid taking the medicine one hour before and one hour after meals. While specific prohibitions on certain foods are not universally established, patients are generally advised to discuss all dietary changes and intake with their prescribing healthcare team.


Q: Does Ufur interact with common pain relievers?

Regulatory documentation notes the potential for interactions with certain substances, including Coumarin Anticoagulants. Pharmacological data indicates that the active components of Ufur may have potential pharmacokinetic interactions with common pain relievers such as Acetaminophen and Acetylsalicylic acid.


Q: Is it safe to take Ufur with vitamins or supplements?

Official drug documentation advises patients to inform their healthcare professional about all medicinal products, including any over-the-counter medicines, vitamins, or dietary supplements. Some supplements may interact to alter the drug’s effects, so complete disclosure is described as important for safety.


Q: What are the general rules for stopping Ufur?

Ufur is administered in defined cycles. Official guidance states that the medicine is to be withheld or permanently discontinued based on the physician’s clinical assessment of severe or toxic adverse events, particularly those affecting the blood, heart, or gastrointestinal tract.


Q: Is Ufur physically or chemically addictive?

Official drug information indicates that no habit-forming or addictive potential has been observed with this medicine.


Q: What is the risk of having a serious allergic reaction to Ufur?

A known severe allergy or hypersensitivity to any component of Ufur is a formal reason to avoid treatment. Official information notes that signs of an allergic reaction, such as rash or itching, are sometimes observed and are required to be reported to a healthcare provider.


Q: Does Ufur need to be taken at a specific time of day?

Yes, the total daily dose is typically divided into two or three administrations throughout the day. The critical instruction is to take the dose with water, specifically avoiding the interval of one hour before and one hour after meals. The dose should be scheduled to meet this timing requirement.


Q: Are there any tests needed before starting Ufur?

Yes, official guidance requires pre-treatment assessments to ensure adequate liver, kidney, and bone marrow function. Additionally, due to the risk of severe toxicity, physicians may consider genetic testing for Dihydropyrimidine Dehydrogenase (DPD) deficiency before beginning the treatment.


Q: Can Ufur be taken alongside alcohol?

The interaction between Ufur and alcohol is not universally established or is listed as unknown in official sources. Consultation with a prescribing healthcare professional regarding the consumption of alcohol during treatment is recommended.


Q: Can men and women use Ufur for the same purposes?

The official purpose (anti-cancer therapy) is the same for both sexes. However, because of the risk of harm to an unborn child, both females and males of reproductive potential are advised of the risk of embryofetal toxicity.


Q: Are there any warnings about Ufur and driving or operating machinery?

Due to the potential for side effects, such as tiredness or neurological changes like confusion, patients are advised that driving or operating heavy machinery may need to be avoided if side effects occur that could lessen their ability to perform these actions safely.


Q: What are the most common reasons people stop taking Ufur?

The most common adverse reactions requiring dose reduction or discontinuation in clinical trials include severe hematologic events (like low white blood cell counts) as well as significant fatigue and diarrhea, particularly when these reactions are severe.


Q: Has Ufur been approved in major countries like the US or Europe?

Regulatory sources indicate that while Ufur (Tegafur-Uracil) is approved in certain countries outside the United States and Europe, it is currently not approved by the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA).


Q: How do doctors monitor the effects of Ufur?

Monitoring procedures involve obtaining complete blood counts (CBCs) prior to and during each treatment cycle. This is done to assess the status of the patient's blood counts. Regular testing of liver and kidney function may also be necessary to monitor the drug’s effects.


Q: Is Ufur a generic or brand-name drug?

Ufur is a brand name used in certain territories for the fixed-dose combination of the two active pharmaceutical ingredients, Tegafur and Uracil. The medicine is a formulated oral therapeutic agent consisting of a specific combination of these two ingredients.


Q: Are there different strengths of Ufur available?

Ufur is a fixed-dose combination of Tegafur and Uracil in a specific molar ratio. While the chemical ratio is fixed, the medicine may be supplied in different total milligram strengths of the combined active ingredients.


Q: Can Ufur be harmful if taken for too long?

Clinical trials often establish a specific treatment period, such as six months for adjuvant therapy. Official documentation notes that the long-term effects beyond the studied duration are not fully established, and the decision on treatment duration is based on the clinical regimen and patient condition.


Q: Are there known symptoms of taking too much Ufur?

Symptoms associated with overexposure can include severe gastrointestinal issues like mucositis and diarrhea, as well as severe blood count suppression and neurotoxicity. Medical attention should be sought immediately in case of known or suspected overexposure.


Q: What is the difference between a side effect and an allergic reaction to Ufur?

In regulatory terms, a side effect (or adverse reaction) is an expected non-intended effect of the drug. An allergic reaction is a specific, potentially severe immune system response to the drug and is classified as a formal contraindication that requires the medicine to be avoided.


Q: Is Ufur known to affect mood?

Official documentation notes serious nervous system adverse reactions, including confusion and disorientation. While general mood effects are not specifically listed, any change in mental status falls under the spectrum of neurological changes that patients are advised to report.


Q: Are there any lifestyle changes recommended when taking Ufur?

Official counseling focuses on using contraception and avoiding certain exposures. Patients may also receive general advice to maintain a healthy diet, get regular exercise, and avoid smoking during their course of treatment.


Q: How is Ufur generally eliminated from the body?

The active component (5-fluorouracil) is primarily eliminated through the metabolism performed by the Dihydropyrimidine Dehydrogenase (DPD) enzyme. This enzyme is responsible for breaking down a large portion of the administered dose.


Q: What is the purpose of the black box warning on Ufur's labeling?

Regulatory agencies require the most serious or life-threatening safety risks to be displayed prominently in a Boxed Warning. For the active agent (Fluorouracil), warnings emphasize the significant risk of serious or potentially fatal adverse reactions in patients who have a deficiency of the DPD enzyme.

How should Ufur be stored and disposed of?

How to Store and Dispose of Ufur (Tegafur and Uracil)

Ufur capsules must be stored strictly according to the conditions defined in the official regulatory documents.

Storage Requirements

Condition Requirement
Temperature Store in a cool, dry place below 30 C (86°F).
Protection Keep away from direct sunlight and heat.
Handling Keep the product in the original container and do not open, crush, or chew the capsules.

Disposal and Safety

Ufur is a cytotoxic agent, and specific handling procedures must be followed. The medicine must be kept safe and out of the reach of children. Unused or expired capsules must not be thrown in household trash or flushed down a toilet or sink. Instead, they must be disposed of through a dedicated drug take-back program or returned to a hospital or pharmacy for proper hazardous waste disposal, as required by law.

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

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