What does Tolak treat?

Tolak (Fluorouracil) may be used to treat breast neoplasms, basal cell carcinoma, colonic neoplasms, head and neck neoplasms, keratosis, pancreatic neoplasms, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.

Tolak is a nucleoside metabolic inhibitor. Nucleoside metabolic inhibitors are fake DNA building blocks that fast-dividing cancer cells mistake for the real thing. Once inside, they get incorporated into the cell's DNA and also block enzymes such as ribonucleotide reductase, which together halt DNA copying and cause the cancer cell to die.

pharmaranks gives Tolak a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.

How much does Tolak cost?

Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.61 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.

Is there a coupon or discount for Tolak?

pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Tolak. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.

Tolak is marketed by Hill Dermaceuticals. You can see Hill Dermaceuticals's full profile, rating, and other products on pharmaranks.

Is Tolak a brand-name or generic drug?

Tolak is a brand-name product with the active ingredient Fluorouracil. Lower-cost generic equivalents containing Fluorouracil are available — ask your pharmacist.

Is Tolak available over the counter?

No. Tolak is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.

What forms does Tolak come in?

Tolak is currently marketed as topical, per the FDA's National Drug Code Directory.

What class of drug is Tolak?

Tolak is classified as nucleoside metabolic inhibitor, per the FDA's Established Pharmacologic Class.

Is Tolak FDA-registered?

Tolak is on record with the U.S. FDA under application number NDA022259. You can verify this on its official FDA label.

Has Tolak been recalled by the FDA?

Tolak has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.

There's no single safe-or-not verdict. pharmaranks gives Tolak a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.

#1 of 8 in Nucleoside Metabolic Inhibitor

tolak

Pharmaranks rates Tolak 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Tolak (Fluorouracil) is a nucleoside metabolic inhibitor used to treat Breast Neoplasms, Basal Cell Carcinoma, Colonic Neoplasms, Head and Neck Neoplasms.

Fluorouracil · by Hill Dermaceuticals

Available as a generic: Fluorouracil

72/100Limited · 1 source

Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →

Rated against independent regulatory sources·Last updated August 18, 2026·How we rate

Verified againstopenFDANIH DailyMedRxClass

$0.61 /mL

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Key facts

Active ingredient: Fluorouracil
Drug class: Nucleoside Metabolic Inhibitor
Form: Topical
Strength: Fluorouracil 4%
Type: Prescription (Rx)
Brand or generic: Brand-name
May treat: breast neoplasms, basal cell carcinoma, colonic neoplasms
Manufacturer: Hill Dermaceuticals
What the pharmacy pays: ~$0.61 per ml — not your price
FDA application: NDA022259

What is Tolak?

From the FDA label:Tolak (fluorouracil) Cream, 4% contains 40 mg of fluorouracil per gram of white cream for topical application. It is a nucleoside metabolic inhibitor. Chemically, fluorouracil is 5-fluoro-2,4 (1H,3H)-pyrimidinedione. The molecular formula of 5-fluorouracil is C 4 H 3 FN 2 O 2 , and its molecular weight is 130.1. Its structural formula is: Tolak Cream contains the following inactive ingredients: arlacel-165, butylated hydroxytoluene, cetyl alcohol, anhydrous citric acid, glycerin, isopropyl myristate, methyl gluceth-10, methylparaben, propylparaben, purified water, peanut oil, sodium hydroxide, stearic acid, and stearyl alcohol. Tolak Cream formulation has an alkaline pH at 8.3 to 9.2. Chemical Structure

How to use

Prior to application of Tolak Cream, wash, rinse, and dry the treatment areas. Apply Tolak Cream once daily in an amount sufficient to cover the lesions of the face, ears, and/or scalp with a thin film, using the fingertips to gently massage the medication uniformly into the skin. Apply Tolak Cream for a period of 4 weeks as tolerated. Thoroughly wash hands following Tolak Cream application. Tolak Cream is for topical use only. Do not apply to eyes, nose, mouth or mucous membranes. Not for ophthalmic, oral or intravaginal use. Apply Tolak Cream after washing, rinsing, and drying the treatment area(s) ( 2 ). Apply Tolak Cream once daily in an amount sufficient to cover the lesions of the face, ears, and/or scalp with a thin film, using the fingertips to gently massage the medication uniformly into the skin ( 2 ). Tolak Cream should be applied for a period of 4 weeks as tolerated ( 2 ). Wash hands thoroughly following Tolak Cream application ( 2 ). Tolak Cream is for topical use only. Do not apply to eyes, nose, mouth or mucous membranes ( 2 ). Not for ophthalmic, oral, or intravaginal use ( 2 ).

Side effects

The following serious adverse reactions are discussed in more detail in other sections of the labeling: Application Site Adverse Reactions [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Ophthalmic Adverse Reactions [see Warnings and Precautions (5.3) ] Photosensitivity [see Warnings and Precautions (5.4) ] Embryofetal toxicity [see Warnings and Precautions (5.5) ] Toxicity in Patients with Dihydropyrimidine Dehydrogenase Deficiency [see Warnings and Precautions (5.6) ] The most common (incidence > 68%) adverse reactions occur at the application site and include erythema, scaling/dryness, crusting, pruritus, stinging/burning, edema, and erosions. Erythema is observed in 99% of patients with actinic keratosis treated with Tolak Cream ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Hill Dermaceuticals at 1-800-344-5707 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect exposure to Tolak Cream in 397 subjects with actinic keratosis in vehicle-controlled trials. The population ranged in age from…

Warnings

Important safety information

Application site adverse reactions are likely to occur during and for 4 weeks after treatment of actinic keratosis with Tolak Cream ( 5.1 ). Hypersensitivity reactions may occur with Tolak Cream ( 5.2 ). Avoid treatment in the periocular area. Eye disorders, including corneal reactions have occurred with topical fluorouracil use. Avoid accidental transfer of the drug into eyes and to the periocular area. If accidental exposure occurs, seek medical care ( 5.3 ). Increased sensitivity to ultraviolet light may occur during and immediately after treatment with Tolak Cream ( 5.4 ). Fluorouracil may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception ( 5.5 ). Increased fluorouracil exposures may occur in DPD deficiency. Discontinue Tolak Cream if symptoms of fluorouracil's systemic toxicity develop ( 5.6 ). 5.1 Application Site Adverse Reactions Application site reactions (erythema, scaling/dryness, edema, crusting, erosions, stinging/burning, and pruritus) were observed in almost all patients during treatment of actinic keratosis on the face, ears, and/or scalp with topical fluorouracil [see Adverse Reactions (6.1) ] . In the clinical trials of Tolak Cream, application site irritation returned to baseline (pre-treatment) levels within 4 weeks after discontinuing treatment. Do not apply Tolak Cream directly into eyes, nose, mouth, or other mucous membranes because irritation, local inflammation and ulceration can occur. 5.2 Hypersensitivity Reactions Allergic contact dermatitis (delayed type hypersensitivity reaction) has been noted for topical fluorouracil drugs. While application site reactions are observed in almost all patients during treatment of actinic keratosis with topical fluorouracil [see Adverse Reactions (6.2) ] , delayed type hypersensitivity should be suspected in the event of severe pruritus or eczema at the application site or at a distant site. Although the potential for a delayed hypersensitivity reaction to fluorouracil exists, patch testing to confirm hypersensitivity may be inconclusive. Tolak Cream contains peanut oil. If signs of hypersensitivity occur, patients should discontinue Tolak Cream immediately and contact their healthcare provider. 5.3 Ophthalmic Adverse Reactions Corneal and conjunctival disorders have occurred with topical fluorouracil use [see Adverse Reactions (6.2) ] . Avoid application to the periocular area. To avoid transfer of the drug into the eyes and to the periocular area during and after application, patients should wash hands well after applying Tolak Cream. If accidental exposure occurs, the patient should flush eye(s) with large amounts of water and seek medical care as soon as possible. 5.4 Photosensitivity Topical fluorouracil is associated with photosensitivity reactions including severe sunburn. Minimize exposure to ultraviolet rays including sunlight, sun lamps, and tanning beds during and immediately following treatment with Tolak Cream because the intensity of the photosensitivity reaction may be increased. 5.5 Embryofetal Toxicity Cases of miscarriage and birth defects (including cleft lip and cleft palate) have been reported when pregnant women were exposed to a topical or parenteral fluorouracil product. In addition, ventricular septal defect and cases of miscarriage occurred when pregnant women applied a topical fluorouracil product to mucous membranes (Tolak Cream is not indicated for use on the mucous membrane). Furthermore, fluorouracil interferes with the synthesis of deoxyribonucleic acid (DNA), inhibits the formation of ribonucleic acid (RNA), and provokes unbalanced growth and death of cells. Therefore, Tolak Cream is contraindicated in pregnancy. Advise females of reproductive potential to use effective contraception during Tolak use and for one month after the last dose of Tolak Cream . 5.6 Toxicity in Patients with Dihydropyrimidine Dehydrogenase Deficiency Life-threatening systemic toxicity has been reported with the topical use of fluorouracil in a patient with DPD deficiency. Symptoms included severe abdominal pain, bloody diarrhea, vomiting, fever, and chills. Physical examination revealed stomatitis, erythematous skin rash, neutropenia, thrombocytopenia, inflammation of the esophagus, stomach and small bowel. A large percentage of fluorouracil is catabolized by the DPD enzyme. DPD enzyme deficiency may result in increased availability of fluorouracil to the anabolic pathway, which may lead to increased interference with DNA and RNA synthesis and increased cytotoxic activity and potential toxicities [see Clinical Pharmacology (12.1) ] . Therefore, Tolak Cream is contraindicated in patients with DPD deficiency. Patients should discontinue Tolak Cream if symptoms of fluorouracil's systemic toxicity develop.

Who should not take Tolak

Tolak Cream is contraindicated: During pregnancy [see Warnings and Precautions (5.5 , 8.1) ] In patients with dihydropyrimidine dehydrogenase (DPD) deficiency [see Warnings and Precautions (5.6) ] Pregnancy ( 4.1 , 8.1 ). Dihydropyrimidine dehydrogenase (DPD) deficiency ( 4.2 ). 4.1 Pregnancy Tolak Cream may cause fetal harm when administered during pregnancy and is contraindicated in women who are pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the fetus. 4.2 Dihydropyrimidine Dehydrogenase Deficiency Tolak Cream is contraindicated in patients with dihydropyrimidine dehydrogenase (DPD) deficiency.

Interactions

Subjects using systemic steroids, immunosuppressants, and immunomodulators were generally excluded from the clinical studies of Tolak Cream, as were subjects who used retinoids, topical steroids, glycolic acid products, alpha-hydroxy products, and chemical peeling products in the treatment areas. No clinical trials were designed to specifically evaluate drug interactions.

Drug class

Nucleoside Metabolic Inhibitor

How this class works, per Gemcitabine — LiverTox, NCBI Bookshelf (NIH).

May treat (source: NIH RxClass)

See how Tolak ranks — best-rated nucleoside metabolic inhibitor for:

Dosage forms

Topical

The forms currently marketed in the U.S., per the FDA National Drug Code Directory.

Ways to save

Ask for the generic

Same active ingredient, far cheaper. Is there a generic? →

Request a 90-day supply

Bulk fills usually lower the per-dose price vs monthly refills.

Use copay cards

Manufacturer copay cards & patient-assistance programs — especially for brand drugs.

Compare alternatives

A same-class option may cost less. See alternatives →

Frequently asked questions

What does Tolak treat?: Tolak (Fluorouracil) may be used to treat breast neoplasms, basal cell carcinoma, colonic neoplasms, head and neck neoplasms, keratosis, pancreatic neoplasms, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
How does Tolak work?: Tolak is a nucleoside metabolic inhibitor. Nucleoside metabolic inhibitors are fake DNA building blocks that fast-dividing cancer cells mistake for the real thing. Once inside, they get incorporated into the cell's DNA and also block enzymes such as ribonucleotide reductase, which together halt DNA copying and cause the cancer cell to die.
How is Tolak rated?: pharmaranks gives Tolak a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
How much does Tolak cost?: Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.61 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
Is there a coupon or discount for Tolak?: pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Tolak. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Tolak?: Tolak is marketed by Hill Dermaceuticals. You can see Hill Dermaceuticals's full profile, rating, and other products on pharmaranks.
Is Tolak a brand-name or generic drug?: Tolak is a brand-name product with the active ingredient Fluorouracil. Lower-cost generic equivalents containing Fluorouracil are available — ask your pharmacist.
Is Tolak available over the counter?: No. Tolak is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
What forms does Tolak come in?: Tolak is currently marketed as topical, per the FDA's National Drug Code Directory.
What class of drug is Tolak?: Tolak is classified as nucleoside metabolic inhibitor, per the FDA's Established Pharmacologic Class.
Is Tolak FDA-registered?: Tolak is on record with the U.S. FDA under application number NDA022259. You can verify this on its official FDA label.
Has Tolak been recalled by the FDA?: Tolak has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
Is Tolak safe?: There's no single safe-or-not verdict. pharmaranks gives Tolak a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
What are the side effects of Tolak?: Tolak's side effects are taken directly from its FDA label. From the label: The following serious adverse reactions are discussed in more detail in other sections of the labeling: Application Site Adverse Reactions [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Ophthalmic Adverse Reactions [see Warnings and Precautions… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.

Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.

Estimate your price

Strength & form

Quantity (mL)

$18.00what the pharmacy pays · 30 ml

NADAC (CMS national average) — what the pharmacy paid to acquire this quantity, not what you will be charged. Your price is set after that by your insurer and the pharmacy. Why they differ.

How we rate

methodology →

openFDA / Drugs@FDA84/100· n=4
Regulatoryweight ×1.5

Headline composite72/100

The headline isn't a raw average of the sources above: while data is thin, each source score is pulled toward a neutral 70/100 baseline (a confidence adjustment for sample size), so it firms up toward the raw scores as more data accumulates. how we rate →

See alternatives to TOLAK →Is there a generic for TOLAK? →