This page shows what was measured, who it was measured in, and what that does not settle.
What Fluorouracil does in the body
Tolak (fluorouracil) Cream is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp.
From the FDA-approved label: Fluorouracil is a nucleoside metabolic inhibitor that interferes with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA); these affect rapidly growing cells and may lead to cell death. Fluorouracil is converted to three main active metabolites: 5-fluoro-2′-deoxyuridine-5′-monophosphate (FdUMP), 5-fluorouridine-5′- triphosphate (FUTP) and 5-fluoro-2′-deoxyuridine-5′-triphosphate (FdUTP). These metabolites have several effects including the inhibition of thymidylate synthase by FdUMP, incorporation of FUTP into RNA and incorporation of FdUTP into DNA.
Why people take it. Tolak (fluorouracil) Cream is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · U3P01618RT · read 2026-08-29
Where each sentence above came from
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 137 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Protein
A protein is a folded chain your body builds to do a specific job.
A picture of it, and where the picture fails
A protein is like a tool bent into one shape for one task.
Where that stops being true. A tool keeps its shape. A protein can change shape and stop working.
What people get wrong. Protein in food and a protein in the body are related but not the same thing.
A polymer of amino acids folded into a defined structure that determines its function.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Healthy ageing
…Waiting for a reviewer1 registered study measure of this kind. No reviewed result yet.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Healthy ageing
all cause mortality
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
… Waiting for a reviewer
1 registered study measure of this kind. No reviewed result yet.
∅ Nothing in the sources checked
No registered study lists a performance measure for this goal.
— Not recorded
Harms were not a registered measure for this goal.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
To determine the objective response rate of patients with metastatic colorectal cancer received the combination of drugs
✗ The study did not show it
Who was studied
NCT01196260
How many people
8000
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Distant metastasis-free survival at 5 years
✗ The study did not show it
Who was studied
NCT00433589
How many people
6600
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
3-year disease-free survival
✗ The study did not show it
Who was studied
NCT00749450
How many people
6088
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer
✗ The study did not show it
Who was studied
NCT00002582
How many people
6000
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Disease free Survival (DFS)
✗ The study did not show it
Who was studied
NCT04089631
How many people
4812
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings
✗ The study did not show it
Who was studied
NCT01358877
How many people
4804
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Injection
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.12 registered measures of this kind. 4 written-up studies measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
□Symptoms and quality of lifeNo evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat, Dog. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
No registered study measured anything of this kind.
Measured
Things only a test, a scale or a device shows.
No registered study measured anything of this kind.
Meaningful
Things that change how a life goes, not only a number.
survival
duration of remission
overall survival
disease free survival
2 year disease free survival
six month survival
all cause mortality
progression free survival
survival at 6 months
recurrence free survival
and 2 more.
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (28)
clinical response
response rate
time to progression
complete response
complete response rate
maximum tolerated dose
experiencing adverse events
tumor response
toxicity
confirmed response rate
time to recurrence
pathological response
clinical response rate
tumor response rate
response
adverse events
overall toxicity
pathological complete response rate
successes
complete response rate at 6 months
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
Fluorouracil is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Safety and effectiveness in children have not been established.”
US prescribing information · 59de2709-00b8-4f0a-867c-f0dfeb947192 · read 2026-08-30
On older people, the label states: “No dose adjustment is required for elderly patients [see Clinical Studies (14) ] .”
US prescribing information · 59de2709-00b8-4f0a-867c-f0dfeb947192 · read 2026-08-30
On people who are pregnant, the label states: “Teratogenic Effects: Pregnancy Category X [see Contraindications (4.1) ] .”
US prescribing information · 59de2709-00b8-4f0a-867c-f0dfeb947192 · read 2026-08-30
On people who are breastfeeding, the label states: “Because many drugs are excreted in human milk and there is some systemic absorption of fluorouracil after topical administration, and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue drug use, taking into account the importance of the drug to the mother.”
US prescribing information · 59de2709-00b8-4f0a-867c-f0dfeb947192 · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Injection
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Suppression classes recorded: S1, S3, S4, S6.
No source is stored against this line.
What is in the pack
Sold as injectable, injectable, cream, solution, given by the injection, injection, topical route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Fluorouracil appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 35927 reaction mentions were counted. One report can name several reactions.
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Injection
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
60 products list this as an active ingredient in the United States drug directory. 60 of them contain it and nothing else.
FDA National Drug Code directory · 70366-003 · read 2026-08-29
They are sold as cream, injection, solution, powder and solution, taken intravenous and topical.
FDA National Drug Code directory · 70366-003 · read 2026-08-29
The regulator's established pharmacologic class for it is nucleic acid synthesis inhibitors [moa] and nucleoside metabolic inhibitor [epc].
FDA National Drug Code directory · 70366-003 · read 2026-08-29
39 published labels name it as an active ingredient. 39 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 06475bd8-66d9-4f88-90e4-b367480dab39 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 06475bd8-66d9-4f88-90e4-b367480dab39 · read 2026-08-29
7 marketed supplement labels list this ingredient, classed as other combinations and vitamin.
Those labels carry all other, nutrient and structure/function claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
TOLAK is topical at 3 DOSAGE FORMS AND STRENGTHS Cream: 40 mg of fluorouracil per gram (4%) of white cream in 40 gram tubes., recorded as fda label in effect 2022-09-06 in the United States.
US prescribing information · 59de2709-00b8-4f0a-867c-f0dfeb947192 · read 2026-08-30
Recorded price in US: 0.6034–42.74289 USD per one gram, across 7 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Recorded price in US: 3.61133–4.20698 USD per one millilitre, across 3 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Fluorouracil studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Fluorouracil are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Where else this substance is registered
FDA substance identifier (UNII)
U3P01618RT
RxNorm concept
105583
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Quoted from a stored source.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S1, S3, S4, S6.
✓ Passed
Canonical metadata present
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How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
52 approved applications cover products containing this substance. The earliest was NDA012209, approved 19620425 to SPECTRUM PHARMS.
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6 questions this page could not answer
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Recorded evidence blocks (12)
Q2
What did Fluorouracil's largest trial (6088 people) and its longest (29 years) measure?
6088 people in Fluorouracil's largest registered study, 29 years in its longest registered window, measuring All-cause mortality. ClinicalTrials.gov · 2026-09-01
650 phase2, 322 phase3, 257 phase1, 31 na, 13 na or unstated, 11 early phase1, 11 phase4; NCT00427570; 2006-05. Last human test completed 2026, NCT04522336.
Interpretation These counts include studies where Fluorouracil was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase2
650
phase3
322
phase1
257
na
31
na or unstated
13
early phase1
11
2 more recorded rows
phase4
11
Last recorded human testNCT04522336
2026-08-07
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Fluorouracil shown lifespan?
10 recorded entries; human; also "Fluorouracil 400 mg/m^2", "fluorouracil cream 0.5%", "Fluorouracil 0.5%"
Show the evidence
human
NCT00069095
Fluorouracil 400 mg/m^2
NCT00377273
fluorouracil cream 0.5%
NCT00696488
Fluorouracil 0.5%
NCT01354717
Generic 0.5% 5-fluorouracil cream
NCT01525329
Fluorouracil Cream, USP 5%
NCT02019355
5-fluorouracil 5% cream
4 more recorded rows
humanNCT02133014
0.5% 5-fluorouracil normal saline
humanNCT02242747
5% 5-FU
humanNCT03283761
5-FU 1200 mg/m^2 x 2 D
humanNCT03996252
Efudex 5% Topical Cream
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which of 2 year disease free survival, achieved pathological complete remission and adverse events did Fluorouracil's trials measure?
2 year disease free survival, achieved pathological complete remission and adverse events lead 40 outcome terms across Fluorouracil's trials. ClinicalTrials.gov · 2026-09-01
Interpretation duration of remission, overall survival, time to progression, complete response, complete response rate and disease free survival follow.
Show the evidence
clinical response
1
survival
1
response rate
1
duration of remission
1
overall survival
1
time to progression
1
14 more recorded rows
complete response
1
complete response rate
1
disease free survival
1
2 year disease free survival
1
maximum tolerated dose
1
experiencing adverse events
1
tumor response
1
toxicity
1
confirmed response rate
1
time to recurrence
1
pathological response
1
clinical response rate
1
tumor response rate
1
six month survival
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Fluorouracil's 220 ongoing trials reports first?
Number of Patients with Response; Rate of pathologic complete response; latest 2036-11-07
Show the evidence
Trial
NCT00082706
"Fluorouracil, Leucovorin, Gemcitabine, and Cisplatin in Treating Patients With Metastatic or Unresectable Adenocarcinoma of the Urothelium or Urachal Remnant"; n 46; "Number of Patients with Response"; 2025-12-31
NCT00335816
"Radiation Therapy and Fluorouracil With or Without Combination Chemotherapy Followed by Surgery in Treating Patients With Stage II or Stage III Rectal Cancer"; n 248; "Rate of pathologic complete response"; 2026-12
NCT00433420
"Combination Chemotherapy With or Without Fluorouracil and/or Pegfilgrastim in Treating Women With Node-Positive Breast Cancer"; n 2000; "Disease-free survival"; 2027-12
NCT00492999
"Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combined With Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver"; n 64; "Resectability rate"; 2027-05
NCT00588770
"Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma"; n 403; "Overall Survival (OS)"; 2027-02-20
NCT00798070
"Panther: A Study Comparing Biweekly and Tailored EC-T Versus Three Weekly FEC-T in Breast Cancer Patients"; n 2017; "Breast cancer relapse-free survival"; 2028-01
14 further recorded trials
NCT01154920
"Paclitaxel, Carboplatin and Cetuximab (PCC) With Cetuximab, Docetaxel, Cisplatin and Fluorouracil (C-TPF) in Previously Untreated Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma"; n 128; "Number of Patients with Progression-Free Survival (PFS)"; 2027-12-31
NCT01954992
"Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer"; n 480; "Overall Survival"; 2026-12
NCT02135042
"Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA"; n 924; "Progression-free survival (PFS) (Detectable Plasma Epstein Barr virus [EBV] deoxyribonucleic acid [DNA] Cohort Phase II)"; 2026-12-01
NCT02299999
"SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer"; n 1460; "Progression-free survival in the targeted drug arm compared to standard maintenance therapy arm"; 2025-12
NCT02688712
"ExIST Study of LY2157299 (Galunisertib) in Rectal Cancer"; n 50; "Evaluation of pathologic response"; 2026-12
NCT02885753
"Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver"; n 348; "progression-free survival"; 2028-09
NCT02912559
"Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair"; n 712; "Disease Free Survival (DFS)"; 2026-12-18
NCT02919787
"Nordic Pancreatic Cancer Trial (NorPACT) - 1"; n 140; "Overall survival 18 month after randomization"; 2026-04-30
NCT02997228
"Testing the Addition of Atezolizumab to Combination Chemotherapy or Atezolizumab Alone for Metastatic Colon or Rectal Cancer, the COMMIT Study"; n 120; "Progression free survival (PFS)"; 2027-06-01
NCT03073785
"Hypofractionated Stereotactic Body Radiation & Fluorouracil or Capecitabine for Locally Advanced Pancreatic Cancer"; n 46; "Local control With and Without Zometa at Four Months in Follow-up"; 2027-12
NCT03110926
"Induction Chemotherapy for Locally Advanced Esophageal Cancer"; n 40; "Disease-free survival rate"; 2027-05-31
NCT03161522
"Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer"; n 100; "Overall survival (OS)"; 2026-12-31
NCT03303495
"A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC"; n 280; "Progression-free survival (PFS)"; 2026-12-31
NCT03306901
"Chemoradiotherapy Versus Esophagectomy After Endoscopic Resection for Superficial Esophageal Squamous Cell Carcinoma"; n 240; "3-year overall survival"; 2033-12-31
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which running trial of Fluorouracil could settle lifespan?
NCT02299999 measures Progression-free survival in the targeted drug arm compared to standard maintenance therapy arm, reading out 2025-12.
69 open trials; n 1460; "SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer"
Show the evidence
Trial
NCT02299999
"SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer"; n 1460; "Progression-free survival in the targeted drug arm compared to standard maintenance therapy arm"; 2025-12
NCT04821284
"Sonoporation and Chemotherapy for the Treatment of Pancreatic Cancer"; n 120; "Progression-free survival"; 2026-02-28
NCT02919787
"Nordic Pancreatic Cancer Trial (NorPACT) - 1"; n 140; "Overall survival 18 month after randomization"; 2026-04-30
NCT04094688
"Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer"; n 455; "Progression-free Survival (PFS)"; 2026-07-01
NCT05568095
"A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body"; n 1040; "Overall survival"; 2026-08
NCT03504397
"A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer."; n 565; "Progression Free Survival (PFS)"; 2026-09-30
14 further recorded trials
NCT05564403
"Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial)"; n 66; "Overall survival (OS)"; 2026-10-01
NCT01954992
"Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer"; n 480; "Overall Survival"; 2026-12
NCT04762953
"Study of Sequential Systemic Therapy + Intraperitoneal Paclitaxel in Gastric/GEJ Peritoneal Carcinomatosis"; n 40; "Participants with Progression Free Survival at 1-Year"; 2026-12
NCT04776655
"Study in mCRC Patients RAS/BRAF wt Tissue and RAS Mutated LIquid BIopsy to Compare FOLFIRI Plus CetuxiMAb or BevacizumaB"; n 280; "Progression free survival (PFS) in patients with RASmut at liquid biopsy and RASwt on tissue."; 2026-12
NCT02135042
"Individualized Treatment in Treating Patients With Stage II-IVB Nasopharyngeal Cancer Based on EBV DNA"; n 924; "Progression-free survival (PFS) (Detectable Plasma Epstein Barr virus [EBV] deoxyribonucleic acid [DNA] Cohort Phase II)"; 2026-12-01
NCT02912559
"Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair"; n 712; "Disease Free Survival (DFS)"; 2026-12-18
NCT03161522
"Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer"; n 100; "Overall survival (OS)"; 2026-12-31
NCT03303495
"A Study of 2nd-line FOLFIRI ± Bevacizumab vs. Irinotecan ± Bevacizumab in mCRC"; n 280; "Progression-free survival (PFS)"; 2026-12-31
NCT04233866
"Comparing Two Treatment Combinations, Gemcitabine and Nab-Paclitaxel With 5-Fluorouracil, Leucovorin, and Liposomal Irinotecan for Older Patients With Pancreatic Cancer That Has Spread"; n 176; "Overall survival (OS)"; 2026-12-31
NCT00588770
"Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma"; n 403; "Overall Survival (OS)"; 2027-02-20
NCT04008030
"A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)"; n 839; "Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm A All Lines Centrally Confirmed MSI-H/dMMR"; 2027-03-23
NCT03533582
"Cisplatin and Combination Chemotherapy in Treating Children and Young Adults With Hepatoblastoma or Liver Cancer After Surgery"; n 537; "Event-free survival (EFS)"; 2027-03-31
NCT06210360
"Perioperative Treatment in High-risk Resectable Pancreatic Cancer With NALIRIFOX"; n 134; "2-year Overall Survival Rate"; 2027-04-01
NCT04447352
"HIPEC + FLOT vs. FLOT Alone in Patients With Gastric Cancer and GEJ (PREVENT)"; n 200; "Comparison of progression-/disease-free survival (PFS/DFS) between arms"; 2027-05-01
Q9
Which 328 trials of Fluorouracil posted no result?
Posted no result
328 of 328 completed trials
Registrations
NCT00003582, NCT00000758, NCT00002755, NCT00003118, NCT00019474 and NCT00309569, and 322 more
Completion dates
oldest 1996-12; newest 2024-08-27
Show the evidence
Trial
NCT00003582
1996-12
NCT00000758
1998-04
NCT00002755
1999-06
NCT00003118
2000-03
NCT00019474
2000-08
NCT00309569
2000-09
14 further recorded trials
NCT00002783
2001-01
NCT00427310
2001-02
NCT00002897
2001-06
NCT00002828
2001-11
NCT00002870
2002-01
NCT00020345
2002-03
NCT00004089
2002-04
NCT00006103
2002-04
NCT00004913
2002-05
NCT00003543
2002-08
NCT00003585
2002-08
NCT00004059
2002-09
NCT00001569
2002-12
NCT00020787
2002-12
Q10
At the median, Fluorouracil's trials enrolled 70.5 people — anything larger?
Median enrolment
70.5
Largest enrolment
6088
Registered trials counted
1082
Q11
What do 35927 spontaneous reports say about Fluorouracil — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Fluorouracil appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 35927 reaction mentions were counted: diarrhoea 8039; nausea 5281; vomiting 4224; neutropenia 3849. open-targets-adr · CHEMBL185 · 2026-06-24
Show the evidence
diarrhoea
8039
nausea
5281
vomiting
4224
neutropenia
3849
palmar-plantar erythrodysaesthesia syndrome
3195
disease progression
2994
4 more recorded rows
thrombocytopenia
2244
neuropathy peripheral
2203
decreased appetite
1982
mucosal inflammation
1916
recorded 2026-06-24 · last checked 2026-09-04
Q12
Was Fluorouracil studied with exercise?
exercise is named in Fluorouracil's label sentences: "Male Sprague-Dawley rats were randomized to sedentary control (SEDCON, n = 9), sedentary 5-FU (SED5FU, n = 10), exercise control (EXCON, n = 8) or exercise 5-FU (EX5FU, n = 8) groups." openfda-label+europepmc · 2025-09-25
1 recorded statement; exercise
Show the evidence
exercise
Male Sprague-Dawley rats were randomized to sedentary control (SEDCON, n = 9), sedentary 5-FU (SED5FU, n = 10), exercise control (EXCON, n = 8) or exercise 5-FU (EX5FU, n = 8) groups.
recorded 2025-09-25 · last checked 2026-09-04
Q13
What is recorded about Fluorouracil and mTOR?
"Mechanistically, esketamine potentiated 5-FU-driven AMP-activated protein kinase (AMPK) phosphorylation, leading to inhibition of both mammalian target of rapamycin (mTOR) and hyaluronan-mediated motility receptor (HMMR)." — where Fluorouracil and mTOR appear together. Europe PMC · pathway abstract search · 2026-06-29
"Mechanistically, esketamine potentiated 5-FU-driven AMP-activated protein kinase (AMPK) phosphorylation, leading to inhibition of both mammalian target of rapamycin (mTOR) and hyaluronan-mediated motility receptor (HMMR)."
AMPKPMID 41613804
"Mechanistically, esketamine potentiated 5-FU-driven AMP-activated protein kinase (AMPK) phosphorylation, leading to inhibition of both mammalian target of rapamycin (mTOR) and hyaluronan-mediated motility receptor (HMMR)."
mTORPMID 41613804
"Esketamine enhances 5-FU chemosensitivity in colorectal adenocarcinoma by activating the AMPK/mTOR/HMMR signaling axis, thereby suppressing tumor progression and metastatic potential."
AMPKPMID 41613804
"Esketamine enhances 5-FU chemosensitivity in colorectal adenocarcinoma by activating the AMPK/mTOR/HMMR signaling axis, thereby suppressing tumor progression and metastatic potential."
autophagy
PMID 42371362
"The peptide GAGGVGKSAL, identified via virtual screening, specifically disrupts the RRM1-USP19 interface, inhibits excessive autophagy and potently suppresses tumor progression in 5-FU-resistant CRC xenograft models."
PMID 42371362
"This study identifies the novel RRM1-USP19-NEDD4 regulatory axis as a core mediator of autophagy-driven 5-FU resistance in CRC, uncovers a non-canonical, metabolism-independent role of RRM1 as a USP19 stabilizer via competitive inhibition of NEDD4-mediated ubiquitination, and validates GAGGVGKSAL as a promising lead compound targeting this axis to reverse 5-FU resistance."
mTORPMID 41354954
"This study aimed to explore the role of Anx-A1 in modulating apoptosis-autophagy interplay in a 5-FU-resistant colorectal CSC model using HCT 116, particularly through its regulatory effects on the PI3K/AKT/mTOR signaling pathway."
autophagyPMID 41354954
"This study aimed to explore the role of Anx-A1 in modulating apoptosis-autophagy interplay in a 5-FU-resistant colorectal CSC model using HCT 116, particularly through its regulatory effects on the PI3K/AKT/mTOR signaling pathway."
NAD+
PMID 42191404
"Using colorectal cancer cells HCT116 treated with the metabolic inhibitors rotenone and 3-bromopyruvate, as well as the chemotherapeutic agent 5-fluorouracil (5-FU), we show that nuclear NAD(P)H fluorescence decay changes in response to treatment."
PMID 41661673
"MGST1 interacted with and navigated GPR15 redistribution to mitochondria to increase mitochondrial NAD+ abundance, which fueled central carbon metabolism and activated downstream metabolic networks to prime tumors for 5-FU cytotoxicity."
PMID 41661673
"Treatment with the PARP inhibitor rucaparib showed potent synergy with 5-FU and demonstrated robust tumor suppression in patient-derived organoids and xenograft models through NAD+-mediated metabolic perturbation."
AMPKPMID 40106967
"In conclusion, our mice study has shown that chlorogenic acid exerts its protective effects on 5-FU-induced intestinal tissue damage, by reducing oxidative stress and inflammation through the modulation of multiple signaling pathways, including the TLR4/NF-κB/MAPK, AMPK/ SIRT1, and PI3K/AKT axis."
sirtuinPMID 40106967
"In conclusion, our mice study has shown that chlorogenic acid exerts its protective effects on 5-FU-induced intestinal tissue damage, by reducing oxidative stress and inflammation through the modulation of multiple signaling pathways, including the TLR4/NF-κB/MAPK, AMPK/ SIRT1, and PI3K/AKT axis."
recorded 2026-06-29 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 11 source rows
✓ no critical contamination: no quarantine open
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