How should I take Febuxostat?

2 DOSAGE AND ADMINISTRATION Recommended dosage is 40 mg or 80 mg once daily. The recommended starting dosage is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after 2 weeks, the recommended dosage is 80 mg once daily. ( 2.1 ) Patients with severe renal impairment: Limit the dosage to 40 mg once daily. ( 2.2 , 8.6 ) Flare prophylaxis is recommended upon initiation of febuxostat tablets. ( 2.4 ) Can be administered without regard to food or antacid use. ( 2.1 ) 2.1 Recommended Dosage The recommended febuxostat tablets dosage is 40 mg or 80 mg once daily. The recommended starting dosage of febuxostat tablets is 40 mg once daily. For patients who do not achieve a serum uric acid (sUA) less than 6 mg/dL after two weeks, the recommended febuxostat tablets dosage is 80 mg once daily. Febuxostat tablets can be taken without regard to food or antacid use [see Clinical Pharmacology (12.3) ]. Concurrent prophylactic treatment with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended [see Dosage and Administration (2.4) and Warnings and Precautions (5.2) ]. 2.2 Dosage Recommendations in Patients with Renal Impairment and Hepat

What are the common side effects?

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the prescribing information: Cardiovascular Death [see Warnings and Precautions (5.1) ] Hepatic Effects [see Warnings and Precautions (5.3) ] Serious Skin Reactions [see Warnings and Precautions (5.4) ] Adverse reactions in ≥ 1% of patients treated with febuxostat are liver function abnormalities, nausea, arthralgia, and rash., ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc., at 1-866-850-2876 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., In Phase 2 and 3 clinical studies, a total of 2757 patients with hyperuricemia and gout were treated with febuxostat 40 mg or 80 mg daily., For febuxostat 40 mg, 559 patients were treated for ≥6 months..

Who should not take Febuxostat?

4 CONTRAINDICATIONS Febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see Drug Interactions (7) ] .; Febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine.; ( 4 ).

Can I take Febuxostat during pregnancy?

8.1 Pregnancy Risk Summary Limited available data with febuxostat use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. No adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (MRHD). No adverse developmental effects were observed in a pre- and postnatal development study with administration of febuxostat to pregnant rats from organogenesis through lactation at an exposure approximately 11 times the MRHD (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data In an embryo-fetal development study in pregnant rats dosed during the period of organog

Can children take Febuxostat?

8.4 Pediatric Use Safety and effectiveness of febuxostat in pediatric patients have not been established.

Does Febuxostat interact with other medicines?

7 DRUG INTERACTIONS Concomitant administration of febuxostat with XO substrate drugs, azathioprine or mercaptopurine could increase plasma concentrations of these drugs resulting in severe toxicity.; ( 7 ) 7.1 Xanthine Oxidase Substrate Drugs Febuxostat is an XO inhibitor.; Based on a drug interaction study in healthy patients, febuxostat altered the metabolism of theophylline (a substrate of XO) in humans [see Clinical Pharmacology (12.3) ].; Therefore, use with caution when coadministering febuxostat with theophylline.; A drug interaction study of febuxostat and azathioprine, also metabolized by XO, showed an increase in exposure of 6-mercaptopurine which may lead to toxicity [see Clinical Pharmacology (12.3) ] .; Drug interaction studies of febuxostat with other drugs that are metabolized by XO (e.g., mercaptopurine) have not been conducted..

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Febuxostat

Illustration of the usual dosage form, not a product photo.

Chemical structure · PubChem CID 134018

xanthine oxidase inhibitorBoxed warning: Cardiovascular deathIndian prescription status not found in lists checkedJan Aushadhi listed

Febuxostat

फेबुक्सोस्टाट

Febuxostat is a xanthine oxidase inhibitor tablet that lowers uric acid in adults with gout. It is meant for people who responded poorly to, or cannot take, allopurinol. It carries a boxed warning about a higher rate of cardiovascular death.

Generic name: Febuxostat
Used for: Long-term management of high uric acid in adults with gout when allopurinol is not suitable.
Label used: Tablets label, oral, DailyMed set f2c338dc, effective 2026-04
Prescription status (India): Not found in the Schedule H/H1/X/G lists we checked
On NLEM 2022: Not found in the list we checked
NPPA price ceiling: Not listed in the lists we checked

More facts

Jan Aushadhi: Listed (2 product rows)
Banned combinations: None found in the list we checked

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Compiled from official drug labels and Indian government sources. Always follow your doctor's or pharmacist's advice.

Safety at a glance

AlcoholNot mentioned in label text
PregnancyCaution in label textSee wording
BreastfeedingCaution in label textSee wording
DrivingNot mentioned in label text
KidneyCaution in label textSee wording
LiverCaution in label textSee wording

Taken only from the label text cited on this page. "Not mentioned" does not mean safe. Ask your doctor or pharmacist.

What is febuxostat used for?

The label describes febuxostat for long-term management of high uric acid in adults with gout.

It is for people with an inadequate response to allopurinol, who are intolerant to it, or for whom it is not advisable. It is not recommended for high uric acid without symptoms.

Chronic high uric acid in adults with gout
After allopurinol did not work or was not suitable

Source1

How does febuxostat work?

The label says febuxostat blocks xanthine oxidase and lowers uric acid in the blood.

It is not expected to affect other enzymes of purine and pyrimidine handling at usual levels.

Source1

How is febuxostat usually taken?

This page covers the US label for febuxostat tablets taken by mouth, with the dosing the label gives for adults.

This is label-level information, not personal advice. Indian pack labels may differ, and your prescriber's instruction always comes first.

For adults, the label describes a once-daily tablet that starts at the lower strength. The prescriber may raise it if uric acid stays above target after about two weeks.

The label describes limiting the amount in severe kidney impairment. It can be taken with or without food or antacids.

Gout flares can occur at the start, so the label recommends flare prevention with an NSAID or colchicine, and uric acid testing from about two weeks.

Once daily by mouth
With or without food or antacids
Flare prevention suggested at the start
Uric acid blood test to guide the amount

Source1

What are the side effects of febuxostat?

Common

Common effects in the label are liver test changes, nausea, joint pain and rash.
Liver function test changes
Nausea
Joint pain
Rash
Gout flares at the start

Serious: get help

Serious effects described include liver failure, serious skin reactions and cardiovascular death.

Get help now: chest pain, breathlessness, yellow skin or eyes, dark urine, severe rash, blistering or swelling of face. Seek urgent care.

Source1

Who should be careful with febuxostat?

The boxed warning says people with established heart disease had a higher rate of cardiovascular death than with allopurinol.

The label warns of liver injury and serious skin and allergic reactions. It is contraindicated with azathioprine or mercaptopurine.

The label describes pregnancy data as limited. The sections we reviewed do not cover breastfeeding in full.

Boxed warning: cardiovascular death
Liver injury
Serious skin reactions
Do not use with azathioprine or mercaptopurine
Limited pregnancy data

Source1

What medicines interact with febuxostat?

Search interactions

Azathioprine
Mercaptopurine
Other xanthine oxidase substrate drugs
The label says it is contraindicated with azathioprine and mercaptopurine because levels can rise to toxic amounts.
It reports no important interaction with colchicine, naproxen, indomethacin, hydrochlorothiazide, warfarin or desipramine.

Source1

How should febuxostat be stored?

The label gives a storage range of 20 to 25 degrees C.

The label also says to protect it from light.

Follow the storage line on your own pack, and keep medicines out of the reach of children.

Source1

Is febuxostat a prescription medicine in India?

We did not find febuxostat in the Drugs Rules 1945 Schedule H, H1, X or G rows we checked, so we cannot state its Indian prescription status from our lists. Ask your pharmacist or doctor.

We did not find febuxostat on the National List of Essential Medicines 2022 in the list we checked.

The Jan Aushadhi (PMBJP) list we checked has 2 product rows that mention febuxostat. We did not capture prices for them.

Source2

What is the price ceiling for febuxostat?

Jan Aushadhi lists febuxostat products including Febuxostat Tablets 40mg 40mg; Febuxostat Tablets 80mg 80mg. We have not shown a price for them. Check the pack and the seller for the actual price.

Source2

Frequently asked questions

Can I drink alcohol while taking febuxostat?

The label we reviewed does not say. Ask your doctor or pharmacist.

Source1

Is febuxostat safe in pregnancy and breastfeeding?

The label says data in pregnancy are limited and insufficient to judge risk. Ask your doctor or pharmacist.

Source1

Should febuxostat be taken with food?

The label says it can be taken without regard to food or antacid use. Ask your doctor or pharmacist.

Source1

Can febuxostat affect driving or alertness?

The label we reviewed does not say. Ask your doctor or pharmacist.

Source1

Can children or older adults take febuxostat?

The label describes use in adults only. Ask your doctor or pharmacist about children or older adults.

Source1

Is febuxostat on the NLEM and Jan Aushadhi list?

We did not find it on NLEM 2022. Yes, several febuxostat products are in the Jan Aushadhi list we checked.

Source2

Sources

1U.S. FDA-approved label (DailyMed) (f2c338dc-5bab-49f4-a4ac-d8dea8afeea5) Open source · 2026-10-15
2PMBJP (Jan Aushadhi) product list (p27:sno596) Open source · 2026-10-15

Compiled by software from the sources above and checked by automated rules. Last checked: 2026-10-15 · How we use sources · Report a correction

This information is educational and is not a substitute for advice from your doctor or pharmacist. It does not tell you what dose you personally should take. In an emergency call 112.

Safety at a glance

What is febuxostat used for?

How does febuxostat work?

How is febuxostat usually taken?

What are the side effects of febuxostat?

Common

Serious: get help

Who should be careful with febuxostat?

What medicines interact with febuxostat?

How should febuxostat be stored?

Is febuxostat a prescription medicine in India?

What is the price ceiling for febuxostat?

Frequently asked questions

Sources

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