- Side Effects
- Drug Interactions
- Pregnancy & Breastfeeding
- What Else to Know
Generic Name: fluorouracil
Brand Name: Adrucil (discontinued brand)
Drug Class: Antineoplastics, Antimetabolite
What is fluorouracil, and what is it used for?
Fluorouracil (5-FU) is a chemotherapy medication used in the treatment of some cancers including gastric, pancreatic, colorectal, and breast cancers in adults. Fluorouracil is used as a systemic drug administered as intravenous injection in these cancers.
In addition, topical formulations of fluorouracil are used to treat certain types of skin cancers. Fluorouracil is an antimetabolite antineoplastic drug that interferes with cellular metabolic process and synthesis of DNA and RNA, which affects rapidly growing cancer cells leading to their death.
Fluorouracil is a pyrimidine analog that has a structure similar to pyrimidine, one of the compounds that are the building blocks of DNA and RNA. Inside the body, fluorouracil gets converted into its active metabolites which get incorporated into the DNA and RNA in place of the pyrimidines required for the synthesis of DNA and RNA. The fluorouracil metabolites inhibit cell growth and inhibit thymidylate synthase, an enzyme that is essential for DNA replication and repair, leading to extensive DNA damage and cellular death.
4 types of cancer
The uses of fluorouracil include:
- Anal carcinoma
- Advanced biliary tract cancer
- Muscle invasive bladder cancer
- Cervical cancer
- Advanced vulvar cancer
- Esophageal cancer
- Head and neck cancer
- Pancreatic neuroendocrine tumors
- Advanced squamous cell penile cancer
- Advanced or metastatic small bowel adenocarcinoma
- Unknown squamous cell primary cancer
- Fluorouracil injection should be administered only under the supervision of an experienced cancer chemotherapy physician because of the possibility of severe toxic reactions.
- Patient should be hospitalized for the initiation of fluorouracil therapy because of the risk for severe toxic reactions.
- Patients with low or absent dipyrimidine dehydrogenase (DPD) activity due to gene mutations are at a higher risk for serious or fatal adverse reactions. DPD is an enzyme that breaks down pyrimidine derivates thymine and uracil.
- Monitor patients for evidence of acute early-onset or unusually severe toxicity which may indicate reduced or absent DPD activity. Withhold or permanently discontinue fluorouracil based on clinical assessment.
- No fluorouracil dose has been proven safe for patients with absent DPD activity and there is insufficient data to recommend a dose for partial DPD activity.
- Fluorouracil can cause toxicity to various body systems. Patients should be monitored for symptoms and fluorouracil should be withheld if toxicities occur and appropriate therapies instituted. The risks of resumption of fluorouracil after the toxicities have resolved have not been established. Fluorouracil associated toxicities include:
- Cardiotoxicity: Risk factors include administration by continuous infusion and presence of coronary artery disease.
- Hyperammonemic encephalopathy: Elevated ammonia in blood and associated brain damage, with no identifiable cause.
- Neurologic toxicity: Neurological events such as acute cerebellar syndrome that affect balance, coordination and gait, confusion, disorientation, and visual disturbances.
- Fluorouracil can cause severe diarrhea. Administer fluids, electrolyte replacement, or antidiarrheal treatments as necessary, and withhold fluorouracil for Grade 3 or 4 diarrhea until resolved or decreased in intensity to Grade 1, then resume fluorouracil at a reduced dose.
- Fluorouracil can cause inflammation of the gastrointestinal mucous membrane (stomatitis, mucositis, and esophagopharyngitis) resulting in the sloughing of mucous membrane or ulcerations. Withhold fluorouracil for Grade 3 or 4 mucositis and resume fluorouracil at a reduced dose once mucositis has resolved or reduced in severity to Grade 1.
- Fluorouracil can cause fetal harm. Advise women of reproductive potential and men with female partners to use effective contraception during fluorouracil treatment and for up to 3 months following cessation of therapy.
- Fluorouracil can cause hand-foot syndrome (palmar-plantar erythrodysesthesia), symptoms of which include pain, tingling, swelling, tenderness, peeling, and redness in palms and feet soles. Administer treatment for symptom relief, withhold fluorouracil administration for Grade 2 or 3, and resume fluorouracil at a reduced dose when the condition is completely resolved or decreased in severity to Grade 1.
- Fluorouracil can suppress bone marrow function resulting in decreased blood cell counts. Obtain complete blood counts prior to each treatment cycle and as needed. Withhold fluorouracil until Grade 4 myelosuppression resolves; resume fluorouracil at a reduced dose when myelosuppression has resolved or improved to Grade 1 in severity.
- Concomitant use with anticoagulant medications such as warfarin can increase blood clotting time. Monitor the patient and adjust anticoagulant dosage appropriately.
What are the side effects of fluorouracil?
Common side effects of fluorouracil include:
- Loss of appetite (anorexia)
- Oral inflammation (stomatitis)
- Inflammation of the throat and esophagus (esophagopharyngitis)
- Reduced blood flow to the intestinal region (mesenteric ischemia)
- Gastrointestinal (GI) tissue sloughing
- GI ulcer
- GI hemorrhage
- Plaque buildup in coronary arteries (coronary arteriosclerosis)
- Chest pain associated with coronary artery disease (angina pectoris)
- Irregular heart rhythm (cardiac arrhythmia)
- Extra or skipped ventricular beat (ventricular ectopy)
- Cardiac failure
- Reduced blood flow to the heart muscle (ischemic heart disease)
- Heart attack (myocardial infarction)
- Spasm of blood vessel (vasospasm)
- Inflammation and blood clot in the vein (thrombophlebitis)
- Cerebrovascular accident
- Impairment of coordination, balance and gait (cerebellar syndrome)
- Visual disturbance
- Narrowing of the tear duct (lacrimal stenosis)
- Tearing eyes (lacrimation)
- Repetitive and uncontrolled eye movements (nystagmus)
- Light sensitivity (photophobia)
- Nasal bleeding (epistaxis)
- Taste disorder (dysgeusia)
- Hair loss (alopecia)
- Changes in nails (including nail loss)
- Skin reactions including:
- Increased pigmentation over the veins (supravenous hyperpigmentation)
- Rash with itchy, red, flat, and raised lesions (pruritic maculopapular rash)
- Pain, swelling, redness, numbness, or tingling of hands and feet (palmar-plantar erythrodysesthesia)
- Skin fissure
- Dry skin (xeroderma)
- Skin photosensitivity
- Severe, life-threatening skin reactions such as:
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Hypersensitivity reactions
- Severe allergic reaction (anaphylaxis)
- Blood disorders including:
Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:
- Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
- Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
- Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
- Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.
What are the dosages of fluorouracil?
- 50 mg/mL
Colon and Rectal Cancer
- 400 mg/m² intravenous push (IVP) injection on Day 1, followed by 2400-3000 mg/m² IV as a continuous infusion over 46 hours every 2 weeks in combination with leucovorin with or without oxaliplatin/irinotecan
- 500 or 600 mg/m² IV on Days 1 and 8 every 28 days for 6 cycles as a component of a cyclophosphamide-based multidrug regimen
- 200-1000 mg/m²/day as a continuous infusion over 24 hours (as part of a platinum-containing regimen)
- Duration and frequency of each cycle varies based on dose and regimen
- 400 mg/m² IVP on Day 1, followed by 2400 mg/m² IV as a continuous infusion over 46 hours every 2 weeks
- Combination with leucovorin or as a component of a multidrug chemotherapy regimen that includes leucovorin, is 400 mg/m² IVP on Day 1, followed by 2400 mg/m² IV as a continuous infusion over 46 hours every 2 weeks
Other Indications and Uses
- Off-label use for cervical, bladder, hepatic, prostate, endometrial, and head and neck carcinoma
- Safety and efficacy not established
- Fluorouracil overdose can cause life-threatening bone marrow suppression (myelosuppression) including low platelet count (thrombocytopenia), gastrointestinal complications, mucous membrane inflammation (mucositis), weakness (asthenia) irregular heart rhythms (cardiac arrhythmia), swelling (edema) of hands and feet, and neurotoxicity.
- Fluorouracil overdose is treated with oral administration of uridine triacetate within 96 hours after overdose. The safety and efficacy of uridine triacetate administration after 96 hours following fluorouracil infusion is unknown.
What drugs interact with fluorouracil?
Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.
- Fluorouracil has no known severe interactions with other drugs.
- Serious interactions of Fluorouracil include:
- adenovirus types 4 and 7 live, oral
- axicabtagene ciloleucel
- brexucabtagene autoleucel
- ciltacabtagene autoleucel
- idecabtagene vicleucel
- influenza virus vaccine quadrivalent, adjuvanted
- influenza virus vaccine trivalent, adjuvanted
- lisocabtagene maraleucel
- ropeginterferon alfa 2b
- Fluorouracil has moderate interactions with at least 40 different drugs.
- Mild interactions of fluorouracil include:
The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.
It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.
Pregnancy and breastfeeding
- There are no adequate and well-controlled studies of fluorouracil use in pregnant women. Animal studies indicate that fluorouracil may impair both male and female fertility.
- Fluorouracil can cause fetal malformations or loss of pregnancy if administered during pregnancy. Women of pregnancy potential should use effective contraception during fluorouracil treatment and for up to 3 months following cessation of therapy.
- Fluorouracil can damage spermatozoa. Men with female partners should use effective contraception during fluorouracil treatment and for up to 3 months following cessation of therapy.
- It is not known if fluorouracil and its metabolites are present in breast milk, however, many drugs are present in breast milk. Decision should be made to discontinue nursing or the drug, taking into account the importance of the drug to the mother, because of the potential for serious adverse effects in the breastfed infant from fluorouracil.
What else should I know about fluorouracil?
- While you are on fluorouracil therapy, you will need regular blood tests, keep up with your appointments.
- Notify your physician if you have a known dipyrimidine dehydrogenase (DPD) deficiency before the initiation of fluorouracil therapy.
- Contact your physician immediately if you develop:
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Fluorouracil (5-FU) injection is a chemotherapy medication used in the treatment of some cancers including gastric, pancreatic, colorectal, and breast cancers in adults. Common side effects of fluorouracil include nausea, vomiting, diarrhea, loss of appetite (anorexia), oral inflammation (stomatitis), inflammation of the throat and esophagus (esophagopharyngitis), reduced blood flow to the intestinal region (mesenteric ischemia), gastrointestinal (GI) tissue sloughing, GI ulcer, GI hemorrhage, plaque buildup in coronary arteries (coronary arteriosclerosis), chest pain associated with coronary artery disease (angina pectoris), irregular heart rhythm (cardiac arrhythmia), and others.
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Signs of metastatic breast cancer (breast cancer that has spread to other parts of the body) include constant fatigue, constant nausea, loss of appetite and unexplained weight loss.
What Are the 4 Stages of Breast Cancer?
The four stages of breast cancer include Stage I, Stage II, Stage III, and Stage IV. There is one more stage called stage 0 or carcinoma in situ. It means the initial stage where the cancerous cells are confined to their origin and have not acquired the “invasive” character yet.
What Are the 13 Signs of Breast Cancer?
Here are the 13 signs of breast cancer that can help you detect the disease at the earlier stages, allowing for a better prognosis.
What Are The Five Warning Signs Of Breast Cancer?
The majority of breast cancer patients first seek diagnosis because of a lump on the breast. This is one of the five warning signs of breast cancer. Others include changes in the nipple, changes in the breast skin and other symptoms.
Why Is Postmenopausal Breast Cancer Common?
Most postmenopausal women are diagnosed with breast cancer due to weakening immune systems and the cumulative amount of exposure to estrogen over the years.
What Are the Four Types of Breast Cancer?
The four most common types of breast cancer are ductal carcinoma in situ, lobular carcinoma in situ, invasive ductal carcinoma, invasive lobular carcinoma. The designations are based on the locations of the tumors, whether they have spread and where they have spread to.
Breast Cancer in Young Women
About 5% of cases of breast cancer occur in women under the age of 40 years old. Some risk factors for breast cancer in young women include a personal history of breast cancer or breast disease, family history of breast cancer, prior radiation therapy, and the presence of BRCA1/BRCA2 gene mutations. Breast self-exams, clinical breast exams, and screening mammograms may help detect breast cancer. Treatment may include surgery, chemotherapy, radiation, and hormone therapy.
What Is HR and HER2 Breast Cancer?
HR stands for hormone receptor, and HER2 stands for human epidermal growth factor receptor 2. Learn about the difference between these types of breast cancer.
Can Early Menopause Cause Breast Cancer?
Early menopause does not cause breast cancer. An increasing age, and not menopause, can increase your breast cancer risk.
Breast Cancer Clinical Trials
Breast cancer clinical trials are research programs designed to evaluate new medical treatments, drugs, or devices for the treatment of breast cancer. Clinical trials are designed to test the safety and efficacy of new treatments as well as assess potential side effects. Clinical trials also compare new treatment to existing treatments to determine if it's any better. There are many important questions to ask your doctor before taking part in a breast cancer clinical trial.
Breast Cancer During Pregnancy
Breast cancer occurs in about 1 in every 1,000 pregnant women. Treatment of breast cancer during pregnancy involves surgery, but it is very difficult to protect the baby from the dangerous effects of radiation and chemotherapy. It can be an agonizing to decide whether or not to undergo breast cancer treatment while one is pregnant.
What Age Does Breast Cancer Usually Start?
Breast cancer is most often diagnosed in women older than 45 years of age (about 80 percent of all cases).
Breast Cancer Growth Rate
The available evidence suggests that breast cancer may begin to grow around 10 years before it is detected. However, the time for development differs from tumor to tumor.
How Can You Tell if a Guy Has Breast Cancer?
A breast tumor or cancer is suspected if the guy has a hard lump underneath the nipple and areola. Male breast cancer exhibits the same symptoms as female breast cancer, including a lump. Male breast cancer may also cause skin changes around the nipple.
How Can You Detect Breast Cancer Early?
Breast cancer develops from the cells of the breasts and can spread to other parts of the body (metastasis). It is one of the most common cancers diagnosed in women in the United States. A lump in the breast or armpit is often the first sign. Treatment success depends largely on early detection.
How to Manage Menopause Symptoms After Breast Cancer
Breast cancer treatment can cause menopausal symptoms due to the way certain therapies affect the ovaries. Learn about how you can find relief.
What Does Breast Cancer in a Man Feel Like?
Male breast cancer is rare and affects 2.7 out of 100,000 African American men and 1.9 out of 100,000 Caucasian men in the United States.
What Are the Risk Factors for Developing Breast Cancer?
Breast cancer refers to the uncontrolled growth of cells within the breast. The risk factors for developing breast cancer include age, genetics, family history, personal history, menstrual history, breast density, previous radiation therapy, ethnicity, body weight, physical activity level, reproductive history, alcohol consumption and hormone pill use.
What Is the Newest Treatment for Breast Cancer?
Targeted therapies are a newer form of breast cancer treatment. They can be used alone or along with other therapies. Targeted therapies directly target cancer cells or specific processes that contribute to the growth of cancer cells. Target therapy often has fewer side effects.
How Do You Detect Colorectal Cancer?
Colonoscopy is the best way to detect colorectal cancer. Learn about screening tests, diagnosis, staging, and treatment.
What Is the Survival Rate of Localized Breast Cancer?
The 5-year survival rate for localized breast cancer is 99%, and the condition is very treatable. Learn about symptoms and treatment for early stage breast cancer.
What Is the Risk of Breast Cancer by Age?
Age is the most significant risk factor for breast cancer, with the risk increasing with age. The risk peaks during menopause and remains constant or reduces afterwards.
Genetic Testing: Families With Breast Cancer
Breast cancer can be a killer and the decision to get tested to see if a patient is prone to the disease should be discussed with a doctor -- particularly if the woman has a history of breast cancer in her family. Genetic testing can only tell so much about breast cancer risk, however.
How Does Breast Cancer Start?
Breast cancer develops in the cells of the breasts and can spread to other parts of the body (metastasis). It is one of the most common cancers diagnosed in women in the US. Although extremely rare, breast cancer can sometimes occur in men. Breast cancer forms when there are changes or mutations in the deoxyribonucleic acid (DNA), which can cause normal breast cells to become cancerous.
How Is Breast Cancer Cured?
Surgery is the main treatment option for treating stage I breast cancer. Otherwise, the treatment options for breast cancer are determined by the following.
How Can Colon Cancer Be Avoided?
Appropriate lifestyle management, such as eating a proper diet, and regular colon cancer screening could help prevent colon cancer.
How Common Is Breast Cancer in Men?
Breast cancer is more common in women. However, men can get breast cancer too. The chances of occurrence of breast cancer in men are rare. Out of every 100 breast cancer diagnosed in the United States, 1 is found in a man.
What Are the Reasons for Breast Cancer?
Breast cancer is a multifactorial disease that can be caused by genetic and environmental factors. Experts are not yet fully aware of what may be the exact reason for breast cancer. The chances of getting breast cancer depend on the person’s age, personal history, genetic factors, and diet.
What Age Can a Male Get Breast Cancer?
Breast cancer risk in men increases with age, and most men with breast cancer are diagnosed in their 60s and 70s. Learn about causes and risk factors for breast cancer in men.
Treatment & Diagnosis
- Colon and Colorectal Cancer Screening
- What Are the Early Warning Signs of Pancreatic Cancer?
- Bone Marrow Transplantation for Breast Cancer
- What Is the #1 Cause of Pancreatic Cancer?
- Genetic Testing for Breast Cancer
- Radiation Therapy for Breast Cancer
- Role of Estrogen Receptors in Breast Cancer
- Breast Cancer Follow-Up Self-Exam
- Colon Cancer
- Pancreatic Cancer
- Breast Cancer
- Breast Cancer Husband
- Breast Cancer: A Feisty Women's Discussion
- Breast Cancer: Mother-daughter relationships
- Inflammatory Breast Cancer
- Male Breast Cancer
- Breast Cancer
- Breast Cancer: Early Stage Treatments
- Breast Cancer: Clinical Trials - Today's Cutting Edge
- Breast Cancer, Metastatic: Treatment Goals and Therapy Options -- Harold J. Burstein, MD
- Colon Cancer Update
- Breast Cancer: Early Diagnosis and Prevention
- Colon Cancer Update: James Church, MD
- Breast Cancer, Taking Control: Self-Advocacy 101
- Breast Cancer: The Male View on Survival and Support
- Breast Cancer Treatment Update
- Colon Cancer Update with The Cleveland Clinic
- Colorectal Cancer Issues: An Update with Doctors
- Breast Cancer FAQs
- Gastric Cancer FAQs
- Stage IV Colon Cancer That Has Spread to the Liver
- How Long Does a Person Live with Pancreatic Cancer?
- Breastfeeding -- Protection from Breast Cancer?
- Stress and Aggressive Breast Cancer: Cause or Effect?
- Advanced Breast Cancer in Young Women Increasing
- Angelina Jolie's Mastectomy
- Breast Cancer Risk - Reduced With Exercise
- Herceptin Metastatic Breast Cancer Treatment
- Colon Cancer Prevention And Fiber?
- Colon Cancer and Polyp Screening Guidelines
- Hormone Therapy in Survivors of Breast Cancer
- Breast Cancer: Types of Breast Cancer
- Elizabeth Edwards has Breast Cancer Alert
- Colon Cancer Silences Howard Keel
- Colon Cancer, The Genetic Factor
- Exercise Improves Breast Cancer Survival
- How Long Do You Live After Being Diagnosed with Colon Cancer?
- What Are the Early Signs of Colon Cancer?
- Pancreatic Cancer, the Silent Disease
- Does Positive Additude Affect Breast Cancer?
- What Is the Best Way to Prevent Colon Cancer?
- What Is the Survival Rate for Colon Cancer?
- Does HIV Cause Colorectal Cancer?
- How Common and Dangerous Is Male Breast Cancer?
- How Many Breast Cancer Deaths Are there Each Year?
- Where Can Breast Cancer Spread To?
- Why Is Breast Cancer More Common in Females than Males?
- How Much Breast Cancer is Genetic?
- How Long Can Breast Cancer Patients Live?
- Who Does Breast Cancer Affect?
- How Does Breast Cancer Form?
- How Many Breast Cancer Stages Are There?
- How Does Colon Cancer Affect a Person's Body?
- Facts on Breast Cancer Causes, Risk Factors, and Types
- Breast Cancer Symptoms and Signs
- Breast Cancer Detection
- Breast Cancer Treatment
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