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Febuxostat

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Febuxostat does in the body

Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.

From the FDA-approved label: Febuxostat tablets, a xanthine oxidase inhibitor, achieves its therapeutic effect by decreasing serum uric acid. Febuxostat tablets are not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.

Why people take it. Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable.

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 · 101V0R1N2E · read 2026-08-29

  • Its recorded molecular formula is C16H16N2O3S, weighing 316.38.

    US prescribing information · ad40e0f6-850c-429a-87fc-f1eb2361e962 · read 2026-08-30

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 140 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.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

What happened in peopleRead 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.

Percentage of Participants With Primary Major Adverse Cardiovascular Events (MACE) Composite (75% Interim Analysis)

The study did not show it

Who was studied
NCT01101035
How many people
6198
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. Oral

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 Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.

The study did not show it

Who was studied
NCT00430248
How many people
2269
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. Oral

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 Serum Urate <5.0 mg/dL at Month 3

The study did not show it

Who was studied
NCT02139046
How many people
1790
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. Oral

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 Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1.

The study did not show it

Who was studied
NCT00175019
How many people
1086
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. Oral

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 Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL).

The study did not show it

Who was studied
NCT00174915
How many people
1072
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. Oral

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

Development of cerebral or cardiorenovascular events and all deaths

The study did not show it

Who was studied
NCT01984749
How many people
1000
Study design
Not applicable
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. Oral

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 is missing or unclearRead 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.

  • Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.

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 of febuxostat in pediatric patients have not been established.”

    US prescribing information · ad40e0f6-850c-429a-87fc-f1eb2361e962 · read 2026-08-30

  • On older people, the label states: “No dose adjustment is necessary in elderly patients.”

    US prescribing information · ad40e0f6-850c-429a-87fc-f1eb2361e962 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Limited available data with febuxostat use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.”

    US prescribing information · ad40e0f6-850c-429a-87fc-f1eb2361e962 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of febuxostat in human milk, the effects on the breastfed infant, or the effects on milk production.”

    US prescribing information · ad40e0f6-850c-429a-87fc-f1eb2361e962 · read 2026-08-30

  • On people with reduced liver function, the label states: “No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B).”

    US prescribing information · ad40e0f6-850c-429a-87fc-f1eb2361e962 · read 2026-08-30

  • On people with reduced kidney function, the label states: “No dose adjustment is necessary in patients with mild to moderate renal impairment (Cl cr 30 to 89 mL/min).”

    US prescribing information · ad40e0f6-850c-429a-87fc-f1eb2361e962 · 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 takeRead 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 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 (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
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 takeRead 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

Oral

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: S6.

No source is stored against this line.

What is in the pack

Sold as tablet, tablet, film coated, film, tablet, coated, given by the oral 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 takeNothing 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.

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 unclearRead 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

Oral

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

  • 69 products list this as an active ingredient in the United States drug directory. 69 of them contain it and nothing else.

    FDA National Drug Code directory · 71610-450 · read 2026-08-29

  • They are sold as film, powder, tablet, tablet, coated and tablet, film coated, taken oral.

    FDA National Drug Code directory · 71610-450 · read 2026-08-29

  • The regulator's established pharmacologic class for it is xanthine oxidase inhibitor [epc] and xanthine oxidase inhibitors [moa].

    FDA National Drug Code directory · 71610-450 · read 2026-08-29

  • 27 published labels name it as an active ingredient. 27 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · ad40e0f6-850c-429a-87fc-f1eb2361e962 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · ad40e0f6-850c-429a-87fc-f1eb2361e962 · read 2026-08-29

  • Febuxostat is oral at 3 DOSAGE FORMS AND STRENGTHS 40 mg tablets, round, biconvex, green colored, film-coated tablets with ‘721’ debossed on one side and plain on other side. 80 mg tablets, oval, biconvex, green colored, film-coated tablets…, recorded as fda label in effect 2023-11-21 in the United States.

    US prescribing information · ad40e0f6-850c-429a-87fc-f1eb2361e962 · read 2026-08-30

  • Recorded price in US: 0.21142–0.281 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 27 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 takeRead 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 Febuxostat 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 unclearRead 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 Febuxostat 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 peopleRead 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.

How many documents were read

  • 25 documents were read for this substance.

    RNAWiki source record

  • 25 of them state the same proteinBinding, and they agree.

    RNAWiki source record

  • 25 of them state the same volumeOfDistribution, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
101V0R1N2E
RxNorm concept
834235

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: S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

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

  • 17 approved applications cover products containing this substance. The earliest was NDA021856, approved 20090213 to TAKEDA PHARMS USA.

    Drugs@FDA application register · NDA021856 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA021856 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19970227.

    FDA National Drug Code directory · 71610-450 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

9 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (10)

On the Febuxostat label: indicated for what?

"Febuxostat tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. ( 1 )…": indications and usage on Febuxostat's label. DailyMed label · f2c338dc-5bab-49f4-a4ac-d8dea8afeea5 · 2026-04-27

83 registered trials of Febuxostat — at which phases?

Registered studies posting no result
49 of 83

83 registered studies of Febuxostat: 28 phase2, 19 phase3, 18 phase4, 10 na, 10 phase1, 1 early phase1, 1 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

176 with a PubMed record

Show the evidence
  • phase2
    28
  • phase3
    19
  • phase4
    18
  • na
    10
  • phase1
    10
  • early phase1
    1
7 more recorded rows
  • na or unstated
    1
  • completed
    53
  • unknown
    10
  • recruiting
    7
  • not yet recruiting
    5
  • terminated
    5
  • active not recruiting
    3

recorded 2026-09-01 · last checked 2026-09-04

5 of Febuxostat's trials stopped: safety, accrual/recruitment, funding/business, other?

safety (1), accrual/recruitment (1), funding/business (1) and other (2): Febuxostat's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Business Decision (please see below)"; 5 of 83 registered studies

Show the evidence

Trial

  • NCT01549977
    terminated; "Business Decision (please see below)"
  • NCT01701622
    terminated; "unable to enroll participants"
  • NCT02279342
    terminated; "Entry were insufficient as expected."
  • NCT03226899
    terminated; "This action was a business decision \& not related to any efficacy, safety or clinical concerns with lesinurad."
  • NCT03605212
    terminated; "The study was stopped as per EMA waiver granted on 20July2018."

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Febuxostat used Febuxostat 40 mg — over how long?

studies of Febuxostat used the recorded amount. ClinicalTrials.gov · 2026-09-01

15 recorded entries; human; also "Febuxostat 40 mg", "Febuxostat 80 mg", "Febuxostat 80/120mg/day"

Show the evidence

human

  • NCT01883167
    Febuxostat 40 mg
  • NCT02246673
    Febuxostat 80 mg
  • NCT02500641
    Febuxostat 80/120mg/day
  • NCT03425708
    20mg Febuxostat
  • NCT03425708
    20mg Febuxostat pill group
  • NCT03425708
    40mg Febuxostat
9 more recorded rows
  • human NCT03425708
    40mg Febuxostat pill group
  • human NCT05264584
    Febuxostat 80 MG
  • human NCT05574036
    Febuxostat 80 MG Oral Tablet
  • human NCT05815901
    Febuxostat 40 mg placebo
  • human NCT05815901
    Febuxostat 80 mg placebo
  • human NCT06603142
    Febuxostat 20MG Tablets
  • human NCT06603142
    Febuxostat 20MG Placebo
  • human NCT06603142
    Febuxostat 40MG Tablets
  • human NCT06603142
    Febuxostat 40MG Placebo

recorded 2026-09-01 · last checked 2026-09-04

Febuxostat's half-life is 5 hours — which schedules were studied?

5 hours, the half-life Febuxostat's label states: "Febuxostat has an apparent mean terminal elimination half-life (t 1/2 ) of approximately 5 hours to 8 hours." DailyMed label · f2c338dc-5bab-49f4-a4ac-d8dea8afeea5 · 2026-04-27

Show the evidence
  • half life pharmacokinetics
    5 hours; Febuxostat has an apparent mean terminal elimination half-life (t 1/2 ) of approximately 5 hours to 8 hours.
  • metabolism pharmacokinetics
    Metabolism Febuxostat is extensively metabolized by both conjugation via uridine diphosphate glucuronosyltransferase (UGT) enzymes including UGT1A1, UGT1A3, UGT1A9, and UGT2B7 and oxidation via cytochrome P450 (CYP) enzymes including CYP1A2, 2C8 and 2C9 and non-P450 enzymes.

recorded 2026-04-27 · last checked 2026-09-04

Which 21 trials of Febuxostat posted no result?

Posted no result
21 of 21 completed trials
Registrations
NCT00821392, NCT00995618, NCT01416402, NCT01563432, NCT01736514 and NCT01883167, and 15 more
Completion dates
oldest 2007-09; newest 2024-08-24
Show the evidence

Trial

  • NCT00821392
    2007-09
  • NCT00995618
    2010-04
  • NCT01416402
    2011-10
  • NCT01563432
    2012-02
  • NCT01736514
    2012-02
  • NCT01883167
    2013-12
14 further recorded trials
  • NCT02060552
    2014-04
  • NCT02252835
    2014-12
  • NCT02600780
    2015-03
  • NCT02317861
    2015-06
  • NCT02344602
    2015-09-22
  • NCT02866214
    2016-10
  • NCT03131583
    2018-01-29
  • NCT03372200
    2018-07-05
  • NCT02338323
    2018-12
  • NCT03918551
    2019-06-06
  • NCT03395977
    2020-02-27
  • NCT04155918
    2020-09-03
  • NCT05264584
    2022-02-01
  • NCT05575297
    2022-05-09

At the median, Febuxostat's trials enrolled 109 people — anything larger?

Median enrolment
109
Largest enrolment
6198
Registered trials counted
83

What do 1015 spontaneous reports say about Febuxostat — 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.

Febuxostat appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1015 reaction mentions were counted: rash 262; acute kidney injury 190; gout 182; renal failure 85. FAERS via Open Targets · CHEMBL1164729 · 2026-06-24

Show the evidence
  • rash
    262
  • acute kidney injury
    190
  • gout
    182
  • renal failure
    85
  • blood creatinine increased
    80
  • hyperkalaemia
    73
4 more recorded rows
  • rhabdomyolysis
    70
  • blood uric acid increased
    49
  • gouty tophus
    13
  • blood lactic acid
    11

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Febuxostat's label not list?

acute kidney injury, blood creatinine increased and blood lactic acid and 7 more reported for Febuxostat, absent from its label. FAERS via Open Targets · CHEMBL1164729 · 2026-06-24

2 label terms; 10 reported and unlisted; f2c338dc-5bab-49f4-a4ac-d8dea8afeea5

Show the evidence
  • acute kidney injury
    count not stated
  • blood creatinine increased
    count not stated
  • blood lactic acid
    count not stated
  • blood uric acid increased
    count not stated
  • gout
    count not stated
  • gouty tophus
    count not stated
4 more recorded rows
  • hyperkalaemia
    count not stated
  • rash
    count not stated
  • renal failure
    count not stated
  • rhabdomyolysis
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Febuxostat and CYP1A2, CYP2D6 and CYTOCHROME P450: shared by which compounds?

CYP1A2, CYP2D6 and CYTOCHROME P450 appear in Febuxostat's recorded interaction sentences, 8 in all. DailyMed label · f2c338dc-5bab-49f4-a4ac-d8dea8afeea5 · 2026-04-27

CYP1A2, CYP2D6, CYP2D6; 3 shared nodes; pharmacokinetics, clinical_pharmacology

Show the evidence

Interaction statement

  • pharmacokinetics
    Metabolism Febuxostat is extensively metabolized by both conjugation via uridine diphosphate glucuronosyltransferase (UGT) enzymes including UGT1A1, UGT1A3, UGT1A9, and UGT2B7 and oxidation via cytochrome P450 (CYP) enzymes including CYP1A2, 2C8 and 2C9 and non-P450 enzymes.
  • pharmacokinetics
    P450 Substrate Drugs In vitro studies have shown that febuxostat does not inhibit P450 enzymes CYP1A2, 2C9, 2C19, 2D6, or 3A4 and it also does not induce CYP1A2, 2B6, 2C9, 2C19, or 3A4 at clinically relevant concentrations.
  • pharmacokinetics
    Desipramine Coadministration of drugs that are CYP2D6 substrates (such as desipramine) with febuxostat are not expected to require dose adjustment.
  • pharmacokinetics
    Febuxostat was shown to be a weak inhibitor of CYP2D6 in vitro and in vivo .
  • clinical_pharmacology
    Metabolism Febuxostat is extensively metabolized by both conjugation via uridine diphosphate glucuronosyltransferase (UGT) enzymes including UGT1A1, UGT1A3, UGT1A9, and UGT2B7 and oxidation via cytochrome P450 (CYP) enzymes including CYP1A2, 2C8 and 2C9 and non-P450 enzymes.
  • clinical_pharmacology
    P450 Substrate Drugs In vitro studies have shown that febuxostat does not inhibit P450 enzymes CYP1A2, 2C9, 2C19, 2D6, or 3A4 and it also does not induce CYP1A2, 2B6, 2C9, 2C19, or 3A4 at clinically relevant concentrations.
2 more recorded rows
  • Interaction statement clinical_pharmacology
    Desipramine Coadministration of drugs that are CYP2D6 substrates (such as desipramine) with febuxostat are not expected to require dose adjustment.
  • Interaction statement clinical_pharmacology
    Febuxostat was shown to be a weak inhibitor of CYP2D6 in vitro and in vivo .
  • CYP1A2
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Golodirsen, Tinidazole

CYP2D6

  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine

recorded 2026-04-27 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1164729
PubChem CID
92136333
CAS number
407582-45-0
RxCUI
834235
InChIKey
BQSJTQLCZDPROO-UHFFFAOYSA-N
Trade name
Adenuric, Febuxostat krka, Febuxostat mylan, Febuxostat viatris (previously febuxostat mylan), Uloric
Development code
NSC-758874, TMX-67
Also called
feburic, febuxostat 40 mg ir, febuxostat 40 mg xr, febuxostat 80 mg ir, febuxostat 80 mg xr, febuxostat xr, FEBUXOSTAT [EMA EPAR], FEBUXOSTAT [JAN], FEBUXOSTAT [MART.], FEBUXOSTAT [MI], FEBUXOSTAT [ORANGE BOOK], FEBUXOSTAT [USAN]
Salt form
febuxostat tablets, FEBUXOSTAT TABLETS 40 MG, FEBUXOSTAT TABLETS 80 MG
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 6 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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