FDA-filed SPL labeling · retrieved through openFDA

Fluorouracil

Fluorouracil is a chemotherapy drug used intravenously to treat certain cancers and topically to treat precancerous skin lesions and superficial skin cancer.

Brand names TolakEfudexAdrucilFavlyxaCarac +1 more
Drug class ⓘ Nucleoside Metabolic Inhibitor
Rx Forms 3 Routes Intravenous · Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 21 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 →

At a glance
Linked label effectiveFeb 19, 2026
Clinical labels in scope ⓘ21
AvailabilityRx
Earliest approval/marketing year ⓘ1962
FDA-listed product records ⓘ115
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 21, 2026
Other forms & routes:
Injection Topical
⭐ Fluorouracil at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Fluorouracil is a well-established chemotherapy agent used intravenously for colon, breast, stomach, and pancreatic cancers, and topically for precancerous skin lesions and certain superficial skin cancers. It is a powerful drug that requires careful monitoring — especially for DPD enzyme status, heart health, blood counts, and signs of serious toxicity. Always use it exactly as your care team prescribes and report any unusual or severe symptoms promptly.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Fluorouracil can cause serious, life-threatening, or fatal side effects in people who have a complete deficiency of an enzyme called DPD (dihydropyrimidine dehydrogenase). This enzyme is responsible for breaking down most of the drug in your body. If your body cannot break down fluorouracil properly, it can build up to dangerous levels. Before starting fluorouracil, your doctor should test you for genetic variants in the DPYD gene (which controls DPD) unless treatment is urgently needed. If you have complete DPD deficiency, fluorouracil should be avoided — no dose has been proven safe. If you notice severe or unusually early side effects soon after starting treatment, contact your doctor immediately, as this could be a sign of DPD deficiency.

Read the full warning on DailyMed →

📖 Fluorouracil: Patient Information Guide

A plain-language walkthrough of Fluorouracil — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Fluorouracil is available in intravenous and topical forms, each approved for specific uses.

  • Favlyxa (intravenous) treats adenocarcinoma of the colon and rectum, breast, stomach, and pancreas
  • Fluorouracil injection treats adenocarcinoma of the colon and rectum, breast, stomach, and pancreas
  • Tolak Cream (topical) is indicated for actinic keratosis lesions on the face, ears, and scalp
  • Fluorouracil 5% topical cream treats multiple actinic or solar keratoses
  • Fluorouracil 5% topical cream treats superficial basal cell carcinomas when conventional treatment isn't practical
  • Fluorouracil topical solution (5%) treats multiple actinic or solar keratoses
  • Fluorouracil topical solution (5%) treats superficial basal cell carcinomas when conventional treatment isn't practical
⚙️How it works▾

Fluorouracil is a nucleoside metabolic inhibitor — it disrupts the way cells build DNA and RNA. Because cancer cells and abnormal skin cells divide rapidly, they are especially vulnerable. Once in the body, fluorouracil is converted into active forms that block a key enzyme called thymidylate synthase (needed to make DNA), and also get inserted into DNA and RNA directly, interfering with normal cell replication and triggering cell death.

Because it targets rapidly dividing cells broadly, it can also affect healthy fast-growing cells (like those in the mouth, gut, and bone marrow), which explains many of its side effects.

💊How it's taken▾

How fluorouracil is given depends entirely on the form and what it is treating — your prescriber will set the details.

  • Intravenous (Favlyxa, Fluorouracil injection): Administered by a healthcare provider either as a rapid intravenous bolus or a slow infusion lasting many hours or days; the schedule depends on the cancer type and regimen
  • Tolak Cream: Applied once daily to the affected skin area(s) for 4 weeks
  • Fluorouracil 5% topical cream and topical solution: Typically applied twice daily; duration ranges from 2–4 weeks for actinic keratoses to 3–12 weeks for superficial basal cell carcinomas

Never adjust your dose or stop treatment without talking to your doctor first.

🤒Side effects — in detail▾

Side effects vary significantly between the topical and intravenous forms.

  • Topical use (Tolak Cream): Skin redness (erythema), scaling and dryness, crusting, itching, stinging or burning, swelling, and skin erosions at the treatment site are very common — nearly all patients experience some degree of these
  • Postmarketing reports for topical fluorouracil: Eye irritation, conjunctivitis, allergic contact dermatitis, blistering, photosensitivity (sun sensitivity), skin discoloration (hyperpigmentation), scarring, and rarely blood count changes
  • Intravenous use: Mucositis (painful mouth sores), diarrhea, hand-foot syndrome (painful redness and peeling of palms and soles), low blood counts, and heart problems

Call your doctor immediately for chest pain, confusion, sudden neurological changes, severe diarrhea, signs of serious infection, or any reaction that seems unusually severe early in treatment.

⚠️Warnings & precautions▾
  • DPD deficiency: The biggest risk — people who completely lack the DPD enzyme can have life-threatening or fatal toxicity. Genetic testing is recommended before treatment. No safe dose exists for complete DPD deficiency.
  • Heart problems (cardiotoxicity): Fluorouracil can cause angina, heart attack, arrhythmia, and heart failure — especially with continuous infusion and in people with coronary artery disease.
  • Brain/neurologic toxicity: Can cause confusion, disorientation, difficulty walking, or visual disturbances. A rare but serious condition called hyperammonemic encephalopathy (toxic ammonia buildup in the brain) can occur within 72 hours of starting an infusion.
  • Myelosuppression (bone marrow suppression): Fluorouracil can severely lower white blood cells, red blood cells, and platelets, increasing infection and bleeding risk.
  • Mucositis: Severe mouth and throat sores can develop, sometimes leading to ulceration.
  • Hand-foot syndrome: Tingling, pain, swelling, and peeling of the hands and feet — more common with continuous infusion.
  • Embryofetal toxicity: Fluorouracil can cause serious fetal harm. Effective contraception is required during treatment and for 3 months after, for both men and women.
🔀What it interacts with▾

Fluorouracil has an important interaction to be aware of:

  • Warfarin and other coumarin anticoagulants (blood thinners): Fluorouracil can significantly raise the blood-thinning effect of warfarin, increasing the risk of dangerous bleeding. If you take warfarin, your INR (clotting measure) will need to be monitored closely and your warfarin dose may need to be adjusted.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • You should be tested for DPYD gene variants (which affect DPD enzyme activity) before starting fluorouracil — complete DPD deficiency makes treatment potentially fatal
  • Tolak Cream is contraindicated (must not be used) during pregnancy; intravenous fluorouracil can also cause fetal harm — tell your doctor if you are or may be pregnant
  • Breastfeeding is not recommended during treatment — discuss with your doctor whether to stop nursing or stop the medication
  • Both men and women of reproductive potential must use effective contraception during treatment and for 3 months after — fluorouracil may also impair fertility in both sexes
  • People with coronary artery disease face a higher risk of heart-related side effects from intravenous fluorouracil
  • Safety and effectiveness have not been established in children
  • Older adults can use fluorouracil, but careful monitoring is important
🚑If you take too much▾

If too much intravenous fluorouracil is given, prompt action is needed. The label states that uridine triacetate should be administered within 96 hours after the end of the fluorouracil infusion to manage an overdose. If you suspect an overdose or experience extreme or unexpected toxicity, seek emergency medical care immediately.

📡Pharmacodynamics — effects in the body▾

According to the label, the precise relationship between fluorouracil blood levels and its effects — and exactly how quickly those effects develop — is not yet fully characterized. What is known is that fluorouracil disrupts DNA and RNA synthesis in rapidly dividing cells, which can lead to cell death.

🔬Pharmacokinetics — how your body processes it▾

After intravenous bolus injection, fluorouracil spreads throughout the body, including to the intestinal lining, bone marrow, liver, cerebrospinal fluid, and brain. About 5–20% of the drug is excreted unchanged in the urine within six hours; the rest is metabolized primarily in the liver, with breakdown products cleared in the urine over 3–4 hours. The elimination half-life (how long it takes the body to clear half the drug) ranges from about 8 to 20 minutes after a bolus dose. When Tolak Cream is applied topically, some absorption into the bloodstream can occur, though many patients have undetectable blood levels — and the drug is broken down into inactive byproducts.

📦How to store it▾

Storage Conditions Store at 20° to 25°C (68° to 77°F). Do not freeze. Protect from light.

📄 Written from Fluorouracil’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Fluorouracil — the kind of thing our pharmacy team would talk through with you at the counter.

Why does my skin look so bad while using the cream — is that supposed to happen? ▾
Yes, it is actually expected and means the medication is working. When you apply fluorouracil topically to treat actinic keratoses or superficial skin cancer, the treated area typically goes through a sequence: redness first, then blistering, peeling, erosion, and finally healing. This can look alarming, but it's the drug targeting the abnormal skin cells. Complete healing may not be visible until 1 to 2 months after you finish treatment. That said, if reactions feel unbearable or you develop swelling around your eyes, contact your doctor.
What is the DPD deficiency test, and do I really need it before starting? ▾
DPD (dihydropyrimidine dehydrogenase) is the enzyme your body uses to break down most of the fluorouracil you receive. If you're missing this enzyme — either partially or completely — the drug can build up to dangerous levels and cause life-threatening reactions. Your doctor should test you for variants in the DPYD gene before you start, unless there's an urgent medical reason to begin immediately. If you have complete DPD deficiency, fluorouracil is not safe for you. This is one of the most important safety checks before treatment.
Can I use fluorouracil if I'm pregnant or trying to get pregnant? ▾
No — fluorouracil can seriously harm a developing baby and is contraindicated during pregnancy. Tolak Cream must not be used if you are pregnant. For intravenous fluorouracil, the same risk applies. Both women and men should use reliable contraception during treatment and for 3 months after finishing. If you become pregnant during treatment, contact your doctor right away. The drug may also affect fertility in both men and women.
I take warfarin for a blood clot — is it safe to use fluorouracil at the same time? ▾
You can be treated with both, but it requires careful monitoring. Fluorouracil can increase how strongly warfarin thins your blood, which raises your risk of bleeding. Your doctor will need to check your INR (a blood clotting test) more frequently and may adjust your warfarin dose. Make sure every member of your care team knows you're on warfarin before you start fluorouracil.
What symptoms should make me call my doctor right away? ▾
With intravenous fluorouracil, call immediately if you have chest pain or irregular heartbeat, sudden confusion or trouble walking, severe diarrhea, fever or signs of infection, or very sore mouth and throat. Unusually severe side effects appearing very early in your treatment can signal a DPD enzyme problem and need urgent attention. With topical fluorouracil, contact your doctor if you develop eye swelling, signs of serious skin infection, or a reaction that feels out of control.
How long do I need to use the cream, and when will my skin look normal again? ▾
For actinic keratoses, Tolak Cream is applied once daily for 4 weeks. Fluorouracil 5% cream or solution for the same condition is usually applied twice daily for 2 to 4 weeks. For superficial basal cell carcinomas, treatment with the 5% cream or solution runs at least 3 to 6 weeks and sometimes up to 10 to 12 weeks. Even after you finish, the skin may still look red and irritated for a while — full healing can take 1 to 2 months. Stick with your prescriber's timeline and don't stop early without checking in.
Is Fluorouracil available over the counter? ▾
Fluorouracil is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Fluorouracil first available? ▾
Fluorouracil has been available in the United States since at least 1962, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Fluorouracil? ▾
Fluorouracil is supplied by 34 manufacturers listed in the FDA NDC Directory, including Fresenius Kabi USA, LLC, BluePoint Laboratories, Xiromed LLC.

💬 Answers drafted from Fluorouracil’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

🌿Drug & Supplement CheckerFluorouracil vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Fluorouracil NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Fluorouracil comes

Fluorouracil is available in 3 forms. 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

Into a vein
Brands Favlyxa
How this form is used
What it may be used for
  • Favlyxa is used intravenously to treat adenocarcinoma of the colon and rectum
  • Favlyxa is used intravenously to treat adenocarcinoma of the breast
  • Favlyxa is used intravenously to treat gastric (stomach) adenocarcinoma
  • Favlyxa is used intravenously to treat pancreatic adenocarcinoma
Important instructions
  • Favlyxa and Fluorouracil injection are administered by a healthcare provider in a clinical setting — never self-administered
  • Fluorouracil injection may be given as a quick intravenous bolus (rapid injection) or as a slow intravenous infusion over many hours, depending on the regimen
  • Favlyxa requires genetic testing for DPYD variants before the first dose, unless immediate treatment is necessary
  • Dosing schedule and regimen vary by cancer type and are individualized by your oncology team
Available strengths 2 strengths
25 mg/mL 50 mg/mL
79 FDA-listed product records ⓘ

Topical cream, ointment or gel

On the skin
Brands Carac Efudex Fluoroplex Tolak
How this form is used
What it may be used for
  • Tolak Cream is used topically to treat actinic keratosis lesions on the face, ears, and scalp
  • Fluorouracil 5% topical cream is used to treat multiple actinic or solar keratoses
  • Fluorouracil 5% topical cream is used for superficial basal cell carcinomas when conventional treatments are not practical
Important instructions
  • Tolak Cream should be applied once daily as a thin film to the affected area(s) on the face, ears, and/or scalp for 4 weeks; wash and dry the area before applying
  • Tolak Cream should not be applied near the eyes, nose, mouth, or mucous membranes; wash hands thoroughly after each application
  • Fluorouracil 5% topical cream for actinic keratosis is typically applied twice daily until the skin reaches the erosion stage, usually over 2 to 4 weeks
  • Fluorouracil 5% topical cream for superficial basal cell carcinomas is applied twice daily for at least 3 to 6 weeks, and sometimes up to 10 to 12 weeks
Available strengths 5 strengths
5 mg/g 10 mg/g 0.04 g/g 50 mg/g 2 g/40 g
22 FDA-listed product records ⓘ

Topical solution

On the skin
How this form is used
What it may be used for
  • Fluorouracil topical solution (5%) is used to treat multiple actinic or solar keratoses
  • Fluorouracil topical solution (5%) is used for superficial basal cell carcinomas when conventional methods are impractical
Important instructions
  • Fluorouracil topical solution for actinic keratosis is applied twice daily until the inflammatory response reaches the erosion stage, typically over 2 to 4 weeks
  • Fluorouracil topical solution for superficial basal cell carcinoma is applied twice daily for at least 3 to 6 weeks, and may be needed for up to 10 to 12 weeks
  • Apply preferably with a non-metal applicator or glove; if applied with fingers, wash hands immediately afterward
Available strengths 2 strengths
20 mg/mL 50 mg/mL
6 FDA-listed product records ⓘ

📊 Fluorouracil across the U.S. market

How Fluorouracil 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.

3
Dose forms ⓘ
34
Manufacturers
7
Brand names
115
FDA-listed product records ⓘ
1962
First marketed ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (8) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Fresenius Kabi USA, LLC14%
BluePoint Laboratories10%
Xiromed LLC9%
Gland Pharma Limited7%
Avyxa Pharma, LLC6%
Alembic Pharmaceuticals Inc.5%
Other makers49%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Fluorouracil is used

A general measure of how commonly Fluorouracil is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Fluorouracil is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

97,998
Medicaid prescriptions filled (Q1–Q4 2025)
$6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Fluorouracil prescribed? Of the 1,596 medications we measure, Fluorouracil ranks #514 by Medicaid prescriptions — more than 68% of them.

Where Fluorouracil ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #514 of 1,596
#509 Primidone 102,071 Rx #510 Infliximab Injection 101,484 Rx #511 Sulfasalazine 100,958 Rx #512 Atropine Ophthalmic 100,738 Rx #513 Triamcinolone Nasal Sp... 99,808 Rx #514 Fluorouracil 97,998 Rx #515 Cholestyramine Resin 97,696 Rx #516 Doxylamine and Pyridox... 97,428 Rx #517 Dolutegravir 95,552 Rx #518 Cilostazol 94,961 Rx #519 Azelaic Acid Topical 94,548 Rx

Utilization by Fluorouracil product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 50 mg/mL injectable solution is the most-dispensed Fluorouracil product — about 52% of these Medicaid prescriptions.

fluorouracil 50 MG/ML Injectable Solution Most dispensed

51,073 Medicaid prescriptions (Q1–Q4 2025) 52% of Fluorouracil prescriptions shown $2.8M gross reimbursement (before rebates) ≈ $55 per prescription (gross)

Summed across the 20 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 239177

fluorouracil 50 MG/ML Topical Cream

29,365 Medicaid prescriptions (Q1–Q4 2025) 30% of Fluorouracil prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $48 per prescription (gross)

Summed across the 7 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 105583

20 ML fluorouracil 50 MG/ML Injection

9,030 Medicaid prescriptions (Q1–Q4 2025) 9% of Fluorouracil prescriptions shown $450,502 gross reimbursement (before rebates) ≈ $50 per prescription (gross)

Summed across the 4 of 14 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1791736

10 ML fluorouracil 50 MG/ML Injection

7,719 Medicaid prescriptions (Q1–Q4 2025) 8% of Fluorouracil prescriptions shown $306,479 gross reimbursement (before rebates) ≈ $40 per prescription (gross)

Summed across the 5 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1791701

fluorouracil 50 MG/ML Topical Solution

568 Medicaid prescriptions (Q1–Q4 2025) <1% of Fluorouracil prescriptions shown $31,157 gross reimbursement (before rebates) ≈ $55 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310380

fluorouracil 5 MG/ML Topical Cream

168 Medicaid prescriptions (Q3–Q4 2025) <1% of Fluorouracil prescriptions shown $948,608 gross reimbursement (before rebates) ≈ $5,646 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 284191

fluorouracil 20 MG/ML Topical Solution

75 Medicaid prescriptions (Q1–Q4 2025) <1% of Fluorouracil prescriptions shown $5,092 gross reimbursement (before rebates) ≈ $68 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310379

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Fluorouracil, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 40 of 75 listed Fluorouracil NDCs with Medicaid activity.

🔍 Compare Fluorouracil products

A representative set of FDA-listed product records for Fluorouracil — 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.)

Showing 115 of 115 products — FDA National Drug Code Directory. See every product, package size and price: browse all 115 Fluorouracil NDCs →

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.

Ingredient (IN) Fluorouracil RxCUI 4492 5 dose forms · 12 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 372228 In current FDA listings
    Clinical drug / strength (SCD) 25 MG/ML RxCUI 199316 50 MG/ML RxCUI 239177
  3. Dose form (SCDF) Oral Capsule RxCUI 372227 No current FDA listing
    Clinical drug / strength (SCD) 250 MG RxCUI 105584
  4. Dose form (SCDF) Topical Cream RxCUI 377700 In current FDA listings
    Clinical drug / strength (SCD) 5 MG/ML RxCUI 284191 10 MG/ML RxCUI 197709 40 MG/ML RxCUI 1669868 50 MG/ML RxCUI 105583
  5. Dose form (SCDF) Topical Solution RxCUI 372230 In current FDA listings
    Clinical drug / strength (SCD) 20 MG/ML RxCUI 310379 50 MG/ML RxCUI 310380

Look up RxCUI 4492 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.

🏷️ Sold under these brand names

Tolak Efudex Adrucil Favlyxa Carac Fluoroplex

🏭 Manufacturers & labelers

Fresenius Kabi USA, LLC 16 BluePoint Laboratories 12 Xiromed LLC 10 Gland Pharma Limited 8 Avyxa Pharma, LLC 7 Alembic Pharmaceuticals Inc. 6 Accord Healthcare, Inc. 4 Taro Pharmaceuticals U.S.A., Inc. 4 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 4 Bausch Health US, LLC 4 Eugia US LLC 4 Sagent Pharmaceuticals 3 Mylan Pharmaceuticals Inc. 3 Sun Pharmaceutical Industries, Inc. 3 Northstar Rx Llc 2 NuCare Pharmaceuticals,Inc. 2 Accord Healthcare Inc. 2 Meitheal Pharmaceuticals Inc. 2 MEDISCA Inc. 2 Encube Ethicals, Inc. 2 Alembic Pharmaceuticals Limited 2 Letco Medical, Llc 1 Mayne Pharma Inc. 1 IMCD Switzerland AG 1

…and 10 more on the FDA NDC directory.

RxNorm drug class

Fluorouracil belongs to the Nucleoside Metabolic Inhibitor class.

Pharmacologic class Nucleoside Metabolic Inhibitor
Drug family (ATC) Pyrimidine analogues
How it works Nucleic Acid Synthesis Inhibitors

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.

🔬 Where this comes from

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 19, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Fluorouracil.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Fluorouracil after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
21
NDC products indexed
115
Distinct labelers/manufacturers represented
34
Linked representative label ⓘ
Xiromed LLC
Linked label effective
Feb 19, 2026
Composite sections available
24
Linked SPL Set ID
19735014-c6fb-0a05-c330-2e9389c71216
Linked SPL Document ID
4b35b4f1-4de4-42de-e063-6294a90a10ae
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 21 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Xiromed LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.