Fluorouracil
Fluorouracil is a chemotherapy-type medicine (a nucleoside metabolic inhibitor) given by IV for colon, rectal, breast, stomach and pancreatic cancers, and applied to the skin for actinic keratosis and some superficial basal cell carcinomas.
🧬 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 23 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 →
Fluorouracil is a long-standing cancer medicine that disrupts DNA-making in fast-growing cells, given by IV for colon, rectal, breast, stomach and pancreatic cancers and applied to the skin for actinic keratosis (rough, sun-damaged patches) and some superficial basal cell carcinomas, around since about 1962 and available generically. On the skin it predictably leaves treated spots red, crusted and sore before healing; by IV, diarrhea, mouth sores and low blood counts are common. Its boxed warning is about DPD deficiency (missing the enzyme that clears the drug), which can cause severe or fatal reactions, so ask about DPYD gene testing first and report severe early diarrhea or mouth sores promptly.
Clinical pearls
- Fluorouracil can harm an unborn baby, so both partners need effective contraception during treatment and for up to 3 months after.
- If you take warfarin, expect more frequent INR (clotting) checks, since fluorouracil can push clotting times up.
- Tolak cream goes on once daily, while the solution and 5% cream go on twice daily, so check which you have.
- Tell your cancer care team about any heart disease, and treat chest pain or an irregular heartbeat as urgent.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
People with complete DPD deficiency can have serious or fatal reactions to fluorouracil. DPD is an enzyme that breaks the drug down. When it is missing, too much drug stays in the body.
Your doctor should test for DPYD gene variants before you start, unless treatment is urgent. Fluorouracil should be avoided if you are known to have variants causing complete DPD deficiency. Severe mouth sores, diarrhea, low white blood cells and nerve problems soon after starting are signs to report right away.
Patient information guide A plain-language walkthrough of Fluorouracil, written from its FDA label.
What Fluorouracil is used for
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Fluorouracil is used for certain cancers and sun-related skin conditions, depending on the product.
- Favlyxa and Fluorouracil injection (IV): adenocarcinoma of the colon and rectum
- Favlyxa and Fluorouracil injection (IV): adenocarcinoma of the breast
- Favlyxa and Fluorouracil injection (IV): gastric adenocarcinoma
- Favlyxa and Fluorouracil injection (IV): pancreatic adenocarcinoma
- Tolak cream (topical): actinic keratosis lesions of the face, ears and scalp
- Fluorouracil topical solution and 5% cream: multiple actinic or solar keratoses
- Fluorouracil topical solution and 5% cream (5% strength): superficial basal cell carcinomas when conventional methods are impractical
How Fluorouracil works
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Fluorouracil is a nucleoside metabolic inhibitor. It disrupts the making of DNA and, to a lesser degree, RNA. Rapidly growing cells are hit hardest, which can lead to cell death.
The body converts it into three active forms. These block an enzyme needed to build DNA and get built into RNA and DNA.
Fluorouracil dosage
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How it is used depends on the product and route. Follow your prescriber and the label.
- Favlyxa and Fluorouracil injection are given into a vein as a bolus or an infusion. The dose and schedule depend on the cancer type, the regimen, and your response.
- Tolak cream is applied once daily as a thin film for 4 weeks as tolerated, after washing and drying the area.
- Fluorouracil topical solution and 5% cream are applied twice daily. Actinic keratosis treatment usually lasts 2 to 4 weeks. Superficial basal cell carcinomas need at least 3 to 6 weeks and sometimes up to 10 to 12 weeks.
Dosing details from the FDA-approved label
From the Fluorouracil prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adenocarcinoma of the Colon and Rectum (infusional regimen, in combination with leucovorin alone, or in combination with leucovorin and oxaliplatin or irinotecan)
- 400 mg/m2 by intravenous bolus on Day 1, followed by 2400 mg/m2 to 3000 mg/m2 intravenously as a continuous infusion over 46 hours every two weeks
- Adenocarcinoma of the Colon and Rectum (bolus regimen, in combination with leucovorin)
- 500 mg/m2 by intravenous bolus on Days 1, 8, 15, 22, 29, and 36 in 8-week cycles
- Adenocarcinoma of the Breast (component of a cyclophosphamide-based multidrug regimen)
- 500 mg/m2 or 600 mg/m2 intravenously on Days 1 and 8 every 28 days for 6 cycles
Read the label’s full dosing text
2 DOSAGE & ADMINISTRATION •Fluorouracil is recommended for administration either as an intravenous bolus or as an intravenous infusion. (2.1 ) •See Full Prescribing Information for dose individualization (2.1) and dose modifications due to adverse reactions (2.6 ) •See Full Prescribing Information for recommended doses of fluorouracil for adenocarcinoma of the colon and rectum ( 2.2 ) and for recommended doses of fluorouracil as a component of a chemotherapy regimen for adenocarcinoma of the breast (2.3 ), gastric adenocarcinoma ( 2.4 ), pancreatic adenocarcinoma ( 2.5 ) 2.1 General Dose Information Fluorouracil is recommended for administration either as an intravenous bolus or as an intravenous infusion. Do not inject the entire contents of the vial directly into patients. Individualize the dose and dosing schedule of fluorouracil based on tumor type, the specific regimen administered, disease state, response to treatment, and patient risk factors. 2.2 Recommended Dosage for Adenocarcinoma of the Colon and Rectum The recommended dose of fluorouracil, administered in an infusional regimen in combination with leucovorin alone, or in combination with leucovorin and oxaliplatin or irinotecan, is 400 mg/m 2 by intravenous bolus on Day 1, followed by 2400 mg/m 2 to 3000 mg/m 2 intravenously as a continuous infusion over 46 hours every two weeks. The recommended dose of fluorouracil, if administered in a bolus dosing regimen in combination with leucovorin, is 500 mg/m 2 by intravenous bolus on Days 1, 8, 15, 22, 29, and 36 in 8-week cycles. 2.3 Recommended Dosage for Adenocarcinoma of the Breast The recommended dose of fluorouracil, administered as a component of a cyclophosphamide-based multidrug regimen, is 500 mg/m 2 or 600 mg/m 2 intravenously on Days 1 and 8 every 28 days for 6 cycles. 2.4 Recommended Dosage for Gastric Adenocarcinoma The recommended dose of fluorouracil, administered as a component of a platinum-containing multidrug chemotherapy regimen, is 200 mg/m 2 to 1000 mg/m 2 intravenously as a continuous infusion over 24 hours. The frequency of dosing in each cycle and the length of each cycle will depend on the dose of fluorouracil and the specific regimen administered.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Fluorouracil side effects
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With skin products, most side effects occur where the medicine is applied.
Common side effects
- Skin redness at the application site
- Scaling and dryness
- Crusting
- Itching
- Stinging or burning
- Swelling
- Erosions (raw, open patches) at the treated area
When to get medical help
- Get help right away if you have severe or unusually early side effects after starting fluorouracil, such as severe diarrhea, mouth sores or signs of infection. This can signal a DPD enzyme problem.
- Call your doctor or get urgent help for chest pain, irregular heartbeat or signs of heart failure.
- Get help for confusion, disorientation, unsteady walking, coma or vision changes.
- Tell your care team about severe diarrhea.
- Report painful, swollen, tingling or peeling hands and feet (hand-foot syndrome).
- Report severe mouth sores or ulcers.
- Contact your doctor if you notice eye swelling or irritation, severe skin reactions or an allergic reaction with skin products.
These tend to peak at the end of treatment and fade within about 4 weeks afterward. Contact your doctor about severe reactions, eye problems or signs of an allergic reaction. The injection can cause more serious effects, such as heart, blood count, nerve and bowel problems.
Fluorouracil warnings and precautions
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- DPD deficiency: can cause severe or fatal reactions. Testing is advised before the injection unless treatment is urgent.
- Heart problems (angina, heart attack, irregular heartbeat, heart failure) can occur with the injection.
- High ammonia with confusion or other neurologic effects can occur.
- Severe diarrhea, mouth sores and hand-foot syndrome can occur.
- Low blood counts can be severe or fatal. Counts are checked before each cycle.
- Pregnancy: can cause fetal harm.
Fluorouracil interactions
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The main interaction on the label involves warfarin.
- Warfarin: fluorouracil can raise clotting times and INR, so frequent monitoring and dose adjustments may be needed.
Interactions listed in the FDA-approved label
From the Fluorouracil prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Warfarin (anticoagulants and CYP 2C9 substrates): Elevated coagulation times have been reported in patients taking fluorouracil concomitantly with warfarin; the interaction may be due to inhibition of cytochrome P450 2C9 by fluorouracil or its metabolites.
Read the label’s full interactions text
7 DRUG INTERACTIONS 7.1 Anticoagulants and CYP 2C9 Substrates Elevated coagulation times have been reported in patients taking fluorouracil concomitantly with warfarin. While pharmacokinetic data are not available to assess the effect of fluorouracil administration on warfarin pharmacokinetics, the elevation of coagulation times that occurs with the fluorouracil prodrug capecitabine is accompanied by an increase in warfarin concentrations. Thus, the interaction may be due to inhibition of cytochrome P450 2C9 by fluorouracil or its metabolites.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Fluorouracil
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- Tell your doctor about any known DPD deficiency or a past severe reaction to fluorouracil.
- Tolak cream is contraindicated in pregnancy and in DPD deficiency.
- Use effective contraception during treatment and for up to 3 months after (women and men with partners who could become pregnant).
- Tell your doctor if you are breastfeeding.
- Tell your doctor if you have coronary artery disease or other heart problems.
- Safety and effectiveness in children have not been established.
- No differences in safety or effectiveness have been identified in older adults.
Fluorouracil overdose
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For fluorouracil overdose, the label says uridine triacetate should be given within 96 hours after the end of the fluorouracil infusion. Overdose of the injection is managed by a medical team.
What Fluorouracil does in the body
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The label states that the relationship between fluorouracil exposure and its effects, and the time course of those effects, are unknown. Its action involves interfering with DNA and RNA building in rapidly growing cells.
How your body processes Fluorouracil
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After an IV bolus, fluorouracil spreads through the body, including the intestinal lining, bone marrow, liver, spinal fluid and brain. About 5 to 20% leaves unchanged in urine within 6 hours. The rest is mostly broken down in the liver, and the half-life ranges from 8 to 20 minutes depending on dose. The DPD enzyme breaks down over 80% of it.
With Tolak cream, 8 of 21 patients had undetectable blood levels, and others had very low levels, generally highest about 1 hour after application.
How to store Fluorouracil
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Storage Conditions Store at 20° to 25°C (68° to 77°F). Do not freeze. Protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Fluorouracil: pharmacist answers to common questions
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.
What is fluorouracil used for?
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How do I use the skin cream or solution?
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What side effects should I expect on my skin?
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Is there a genetic test I should ask about?
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Can I use it if I'm pregnant or breastfeeding?
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Does it interact with other medicines?
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Is Fluorouracil available over the counter?
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When was Fluorouracil first available?
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Who makes Fluorouracil?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Fluorouracil on HelloPharmacist
Fluorouracil forms and strengths (how it 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Fluorouracil inactive ingredients by manufacturer.
Injection
How this form is used
- Favlyxa is used for adenocarcinoma of the colon and rectum, breast, stomach and pancreas.
- Fluorouracil injection is used for adenocarcinoma of the colon and rectum, breast, stomach and pancreas.
- Favlyxa is given into a vein, either as a bolus or as an infusion.
- Fluorouracil injection is given into a vein, either as a bolus or as an infusion.
- Fluorouracil injection: the vial contents should not be injected directly all at once, and the dose is individualized.
Topical cream, ointment or gel
How this form is used
- Tolak cream is used for actinic keratosis lesions of the face, ears and scalp.
- Fluorouracil 5% cream is used for multiple actinic or solar keratoses and for superficial basal cell carcinomas when usual methods are impractical.
- Tolak cream is applied once daily as a thin film after washing and drying the area, for 4 weeks as tolerated.
- Tolak cream is not for the eyes, nose, mouth, mucous membranes or vaginal use. Wash hands well afterward.
- Fluorouracil 5% cream is applied twice daily to cover the lesions, preferably with a nonmetal applicator or glove.
- Fluorouracil 5% cream: wash hands right away if applied with fingers.
Topical solution
How this form is used
- Fluorouracil topical solution is used for multiple actinic or solar keratoses and, in the 5% strength, for superficial basal cell carcinomas when usual methods are impractical.
- Fluorouracil topical solution is applied twice daily to cover the lesions.
- Fluorouracil topical solution is preferably applied with a nonmetal applicator or glove, and hands are washed right away if fingers are used.
Fluorouracil on the U.S. market: products, makers and brands
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.
21 companies list 44 Fluorouracil product records with the FDA, mostly as injection, topical cream, ointment or gel, topical solution; the earliest marketing or approval year on record is 1962. Brand names on the directory include Tolak, Efudex, Adrucil and 3 more; the rest are generics.
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.
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 (Medicaid data)
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.
How commonly is Fluorouracil prescribed? Of the 1,601 medications we measure, Fluorouracil ranks #514 by Medicaid prescriptions — more than 68% of them.
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.
fluorouracil 50 MG/ML Injectable Solution Most dispensed
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
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
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
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
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
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
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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 50 mg/mL | Intravenous | Accord Healthcare, Inc. | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Alembic Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Alembic Pharmaceuticals Limited × 2 listings | ANDA | View NDC → |
| 25 mg/mL | Intravenous | Avyxa Pharma, LLC × 2 listings | NDA | View NDC → |
| 50 mg/mL | Intravenous | BluePoint Laboratories × 4 listings | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Eugia US LLC × 4 listings | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Fresenius Kabi USA, LLC | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Gland Pharma Limited × 4 listings | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. × 4 listings | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Meitheal Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 50 mg/mL | Intravenous | ProPharma Distribution | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Sagent Pharmaceuticals | ANDA | View NDC → |
| 50 mg/mL | Intravenous | Xiromed LLC × 4 listings | ANDA | View NDC → |
| 💊Topical cream, ointment or gel | ||||
| 50 mg/g | Topical | Accord Healthcare Inc. | ANDA | View NDC → |
| 2 g/40 g | Topical | Bausch Health US, LLC | NDA | View NDC → |
| 50 mg/g | Topical | Dr. Reddy's Labratories Inc. | ANDA | View NDC → |
| 2 g/40 g | Topical | Encube Ethicals, Inc. | ANDA | View NDC → |
| 0.04 g/g | Topical | Hill Dermaceuticals, Inc. | NDA | View NDC → |
| 50 mg/g | Topical | Mayne Pharma Inc. | ANDA | View NDC → |
| 5 mg/g | Topical | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC | View NDC → |
| 50 mg/g | Topical | Northstar Rx Llc | ANDA | View NDC → |
| 50 mg/g | Topical | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 💊Topical solution | ||||
| 50 mg/mL | Topical | Encube Ethicals, Inc. | ANDA | View NDC → |
| 20 mg/mL | Topical | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
| 50 mg/mL | Topical | Sun Pharmaceutical Industries, Inc. | ANDA | View NDC → |
Showing 44 of 44 products — FDA National Drug Code Directory. See every product, package size and price: browse all 44 Fluorouracil NDCs →
Fluorouracil side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Fluorouracil — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Fluorouracil in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Fluorouracil FDA approval history
How Fluorouracil went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Fluorouracil recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Fluorouracil recalls since July 2021.
✅No Fluorouracil recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 4492 5 dose forms · 12 strengths
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Dose form (SCDF) Injectable Solution RxCUI 372228In current FDA listings -
Dose form (SCDF) Injection RxCUI 1791700In current FDA listingsClinical drug / strength (SCD) 10 ML fluorouracil 25 MG/MLRxCUI 273866610 ML fluorouracil 50 MG/MLRxCUI 179170120 ML fluorouracil 50 MG/MLRxCUI 1791736 -
Dose form (SCDF) Oral Capsule RxCUI 372227No current FDA listingClinical drug / strength (SCD) 250 MGRxCUI 105584 -
Dose form (SCDF) Topical Cream RxCUI 377700In current FDA listings -
Dose form (SCDF) Topical Solution RxCUI 372230In current FDA listings
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.
Fluorouracil supply and shortage status
Whether Fluorouracil is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Fluorouracil costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Cream · Topical | 50 mg/g | $0.616 per gram | NDC details & price history |
| Cream · Topical | 2 g/40 g | $1.44 per gram | NDC details & price history |
| Cream · Topical | 5 mg/g | $0.616 per gram | NDC details & price history |
| Solution · Topical | 50 mg/mL | $4.17 per mL | NDC details & price history |
| Solution · Topical | 20 mg/mL | $3.42 per mL | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Fluorouracil brand names
Fluorouracil is sold under 6 brand names in the FDA directory — Tolak, Efudex, Adrucil, Favlyxa and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Fluorouracil: manufacturers and labelers
21 companies list Fluorouracil products with the FDA. By number of product records, the largest are BluePoint Laboratories, Eugia US LLC, Gland Pharma Limited. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Fluorouracil drug class (RxNorm)
Fluorouracil belongs to the Nucleoside Metabolic Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Fluorouracil page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Xiromed LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →