Prescription medicine
Fluorouracil Brand names: Favlyxa, Efudex, Tolak
Fluorouracil (Efudex) is a prescription medicine with an FDA approval on record since 1962. FDA's NDC Directory lists it from 18 generic labelers, and pharmacies paid $0.616 per gram (Fluorouracil 5% cream) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the fluorouracil FDA label on DailyMed (effective January 19, 2026, Eugia US LLC); the NDA 12209 record on Drugs@FDA; every fluorouracil label on DailyMed.
Highlights of the record
FDA label of January 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SERIOUS ADVERSE REACTIONS OR DEATH IN PATIENTS WITH COMPLETE DPD DEFICIENCY.
Increased Risk of Serious Adverse Reactions or Death in Patients with Complete DPD Deficiency Test patients for genetic variants of DPYD prior to initiating fluorouracil unless immediate treatment is necessary. Avoid use of fluorouracil in patients with certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency [see Warnings and Precautions (5.1) ]. WARNING: SERIOUS ADVERSE REACTIONS OR DEATH IN PATIENTS WITH COMPLETE DPD DEFICIENCY See full prescribing information for complete boxed warning Serious adverse reactions or death may occur in patients with complete DPD deficiency. Test patients for genetic variants of DPYD prior to initiating fluorouracil unless immediate treatment is necessary. Avoid use of fluorouracil in patients with certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency.
Used for
From the label: indications and usageFluorouracil injection is indicated for the treatment of patients with: Fluorouracil injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with Adenocarcinoma of the Colon and Rectum ( 1.1 ) Adenocarcinoma of the Breast ( 1.2 ) Gastric Adenocarcinoma ( 1.3 ) Pancreatic Adenocarcinoma ( 1.4 ) 1.1 Adenocarcinoma of the Colon and Rectum.
Forms and strengths
- 0.04 g/g
- 2 g/40g
- 5 mg/g
- 20 mg/ml
- 25 mg/ml
- 50 mg/ml
- 50 mg/g
Injection (solution); cream; solution.
On the market
- Earliest approval on file
- April 25, 1962 Fluorouracil, Spectrum Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 34 first October 13, 1982; 20 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 23 of which 18 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.616 per gram Fluorouracil 5% cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2012 1 Class I among all firms' recalls; latest June 28, 2019; 12 more by firms not listed as its makers
- FAERS reports
- 76,948 through July 30, 2026
What is fluorouracil used for?
From the label: indications and usageFluorouracil injection is indicated for the treatment of patients with: Fluorouracil injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with Adenocarcinoma of the Colon and Rectum ( 1.1 ) Adenocarcinoma of the Breast ( 1.2 ) Gastric Adenocarcinoma ( 1.3 ) Pancreatic Adenocarcinoma ( 1.4 ) 1.1 Adenocarcinoma of the Colon and Rectum. 1.2 Adenocarcinoma of the Breast. 1.3 Gastric Adenocarcinoma. 1.4 Pancreatic Adenocarcinoma.
Conditions named in the indications of fluorouracil's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nucleoside Metabolic Inhibitor.
Source: FDA drug label (FLUOROURACIL), Eugia US LLC, effective January 19, 2026 (SPL set 697816ce-dc05-4943-b7f0-2f0b125e93b7), via openFDA; the full label on DailyMed
What does the patient leaflet for fluorouracil say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while using Tolak Cream?Do not cover the treated areas with an airtight dressing. • Avoid sunlight. Tolak Cream can make your skin sensitive to the sun. You could get severe sunburn. Limit your time in the sun during treatment with Tolak Cream. Talk to your doctor if you get sunburn. Do not breast feed or become pregnant while using Tolak. If you do become pregnant, stop using Tolak and tell your doctor right away. Tolak may be fatal to your pet if your pet licks or ingests Tolak. Avoid allowing pets to contact the Tolak container or your skin where you applied Tolak. Store Tolak out of reach of pets. Safely discard or clean any cloth or applicator that may have Tolak residue. Avoid applying Tolak on your clothing, carpeting, or furniture. If your pet starts vomiting or starts having a seizure after your pet licks or ingests Tolak, seek immediate veterinary care for your pet.
From the patient leaflet: How should I store Tolak Cream?Store Tolak Cream between 68°F to 77°F (20°C to 25°C). Do not freeze Tolak Cream. Do not use Tolak Cream after the expiration date printed on the tube. Keep Tolak Cream and all medicines out of the reach of children.
Source: FDA drug label (TOLAK), HILL DERMACEUTICALS, INC., effective September 6, 2022 (SPL set 59de2709-00b8-4f0a-867c-f0dfeb947192), via openFDA; the full label on DailyMed
Is there a generic for fluorouracil (Efudex)?
The FDA approved the first generic fluorouracil on October 13, 1982. 34 generic applications are approved; 20 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists fluorouracil from 18 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1962 earliest approval on file
- 1982 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fluorouracil (Efudex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.616 per gram (Fluorouracil 5% cream), down 10% from $0.686 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Fluorouracil 5% cream (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fluorouracil 0.5% cream | Generic | $42.88 per gram | n/a | n/a |
| Fluorouracil 2% topical solution | Generic | $3.42 per mL | n/a | -24% |
| Fluorouracil 5% cream | Generic | $0.616 per gram | n/a | -10% |
| Fluorouracil 5% topical solution | Generic | $4.17 per mL | n/a | -11% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has fluorouracil been recalled?
The FDA's Enforcement Report lists 14 recalls naming fluorouracil since 2012: 1 Class I (the most serious), 13 Class II, 0 Class III; 0 still ongoing. 12 of them are by firms that FDA's NDC Directory does not list as a maker of fluorouracil and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 6, 2020 | Class II | The Medicine Shoppe Pharmacy not a listed maker | Lack of Processing Control |
| June 28, 2019 | Class I | Fresenius Kabi USA, LLC | Presence of Particulate Matter; glass particulates |
| June 12, 2019 | Class II | Infusion Options, Inc. not a listed maker | Lack of Assurance of Sterility |
| May 28, 2015 | Class II | Lincare, Inc. not a listed maker | Lack of Assurance of Sterility: Sterility of product is not assured. |
| November 21, 2012 | Class II | Taro Pharmaceuticals U.S.A., Inc. | Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples. |
| May 25, 2012 | Class II | Franck's Lab Inc., d.b.a. Franck's Compounding Lab not a listed maker | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fluorouracil label say about other medicines?
The fluorouracil label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name fluorouracil. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Capecitabine | drug interactions | 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. |
| Warfarin | drug interactions | DRUG INTERACTIONS 7.1 Anticoagulants and CYP 2C9 Substrates Elevated coagulation times have been reported in patients taking fluorouracil concomitantly with warfarin. |
Other labels that name fluorouracil
Source: FDA drug label (FLUOROURACIL), Eugia US LLC, effective January 19, 2026 (SPL set 697816ce-dc05-4943-b7f0-2f0b125e93b7), via openFDA; the full label on DailyMed
What do FAERS reports show for fluorouracil?
The FDA Adverse Event Reporting System holds 76,948 reports that list fluorouracil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10,861 are coded as a death and 30,820 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as fluorouracil?
8 other medicines are given the same way (intravenous) and in the same FDA class as fluorouracil or labeled mainly for the same use (colorectal cancer), the same class first. Colorectal cancer lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Oxaliplatin | Colorectal cancer | 17 labelers | n/a | A presentation being discontinued |
| Irinotecan | Colorectal cancer | 12 labelers | n/a | A presentation being discontinued |
| Levoleucovorin | Colorectal cancer | 8 labelers | n/a | No current entry |
| Bevacizumab | Colorectal cancer | none listed | n/a | No current entry |
| Aflibercept | Colorectal cancer | none listed | n/a | No current entry |
| Bevacizumab-maly | Colorectal cancer | none listed | n/a | No current entry |
| Cetuximab | Colorectal cancer | none listed | n/a | No current entry |
| Panitumumab | Colorectal cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as fluorouracil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to fluorouracil
- 8 medicines for the same use
- Other nucleoside metabolic inhibitors
- the pharmacologic class, with prices and generics
- Fluorouracil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other