Medicine guide

Febuxostat

40 mg · Tablet, Film Coated

Prescription only
Xanthine Oxidase Inhibitor

Active substance: Febuxostat
Used in: Muscles, joints and bones
Made by: American Health Packaging
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2024-01-30

What it is

Xanthine Oxidase Inhibitor

Used for

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…

The label’s usual adult dose

Recommended febuxostat tablets dosage is 40 mg or 80 mg once daily.

Full directions ↓

Serious warning

CARDIOVASCULAR DEATH Gout patients with established cardiovascular (CV) disease treated with febuxostat tablets had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study [see Warnings and Precautions (5.1) ].

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

42other products contain Febuxostat — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Limitations of Use:

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.
Febuxostat is a 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) Limitations of Use :
Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia.
(1)

From the official label · 2024-01-30 · DailyMed

How it works

From this product’s own US prescribing label.

Febuxostat, a xanthine oxidase inhibitor, achieves its therapeutic effect by decreasing serum uric acid.
Febuxostat is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.

Half-life5–8 h

Mostly cleared after≈ 32.5 hfive half-lives — our arithmetic

How the body breaks it down

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.

How it leaves the body

Febuxostat is eliminated by both hepatic and renal pathways.

With food

Following multiple 80 mg once daily doses with a high fat meal, there was a 49% decrease in C max and an 18% decrease in AUC, respectively.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2024-01-30

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

CARDIOVASCULAR DEATH Gout patients with established cardiovascular (CV) disease treated with febuxostat tablets had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study [see Warnings and Precautions (5.1) ].
Consider the risks and benefits of febuxostat tablets when deciding to prescribe or continue patients on febuxostat tablets.
Febuxostat tablets should only be used in patients 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 [see Indications and Usage (1) ].
WARNING:
CARDIOVASCULAR DEATH See full prescribing information for complete boxed warning.
Gout patients with established cardiovascular (CV) disease treated with febuxostat tablets had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study.
(5.1) Consider the risks and benefits of febuxostat tablets when deciding to prescribe or continue patients on febuxostat tablets.
Febuxostat tablets should only be used in patients 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)

Quoted from the official label, section “Boxed Warning”.

Do not take it if

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)

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Recommended febuxostat tablets dosage is 40 mg or 80 mg once daily.
The recommended starting dose 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 Hepatic Impairment The recommended dosage of febuxostat tablets is limited to 40 mg once daily in patients with severe renal impairment.
No dose modification is necessary when administering febuxostat tablets in patients with mild or moderate renal impairment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ].
No dosage modification is necessary in patients with mild to moderate hepatic impairment [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ].
2.3 Serum Uric Acid Level Monitoring Testing for the target serum uric acid level of less than 6 mg/dL may be performed as early as two weeks after initiating febuxostat therapy.
2.4 Recommended Prophylaxis for Gout Flares Gout flares may occur after initiation of febuxostat due to changing serum uric acid levels resulting in mobilization of urate from tissue deposits.
Flare prophylaxis with a non-steroidal anti-inflammatory drug (NSAID) or colchicine is recommended upon initiation of febuxostat.
Prophylactic therapy may be beneficial for up to six months [see Clinical Studies (14.1) ].
If a gout flare occurs during febuxostat treatment, febuxostat need not be discontinued.
The gout flare should be managed concurrently, as appropriate for the individual patient [see Warnings and Precautions (5.2) ].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Gout Flares:
An increase in gout flares is frequently observed after initiation of febuxostat.
If a gout flare occurs during treatment, febuxostat need not be discontinued.
Prophylactic therapy (i.e., non-steroidal anti-inflammatory drug or colchicine) upon initiation of treatment may be beneficial for up to six months.
(2.4 , 5.2) Hepatic Effects: Cases of hepatic failure, some fatal, have been reported.
If liver injury is detected, promptly interrupt febuxostat and treat cause, if possible, to resolution or stabilization.
Permanently discontinue febuxostat if liver injury is confirmed, and no alternate etiology can be found.
(5.3) Serious Skin Reactions:
Serious skin and hypersensitivity reactions, including Stevens-Johnson Syndrome, drug reaction with eosinophilia and systemic symptoms and toxic epidermal necrolysis have been reported in patients taking febuxostat.
Discontinue febuxostat if serious skin reactions are suspected.
(5.4)
5.1 Cardiovascular Death In a cardiovascular (CV) outcome study, gout patients with established CV disease treated with febuxostat tablets had a higher rate of CV death compared to those treated with allopurinol.
Sudden cardiac death was the most common cause of adjudicated CV deaths, 2.7% in the febuxostat tablets group (83 of 3,098) as compared to 1.8% in the allopurinol group (56 of 3,092).
Febuxostat tablets were similar to allopurinol for nonfatal myocardial infarction (MI), nonfatal stroke and unstable angina with urgent coronary revascularization [see Clinical Studies (14.2) ].
Because of the increased risk of CV death, febuxostat tablets should only be used in patients 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 [see Indications and Usage (1) ].
Consider use of prophylactic low-dose aspirin therapy in patients with a history of CV disease.
Monitor patients for the development of CV events.
Inform patients about the symptoms of serious CV events and the steps to take if they occur.
5.2 Gout Flares After initiation of febuxostat, an increase in gout flares is frequently observed.
This increase is due to reduction in serum uric acid levels, resulting in mobilization of urate from tissue deposits.
In order to prevent gout flares when febuxostat is initiated, concurrent prophylactic treatment with an NSAID or colchicine is recommended [see Dosage and Administration (2.4) ].
5.3 Hepatic Effects Cases of fatal and nonfatal hepatic failure in patients taking febuxostat have been reported.
During randomized controlled studies, transaminase elevations greater than three times the upper limit of normal (ULN) were observed (AST:
2%, 2%, and ALT:
3%, 2% in febuxostat and allopurinol-treated patients, respectively).
No dose-effect relationship for these transaminase elevations was noted [see Clinical Pharmacology (12.3) ].
Obtain a liver test panel (serum alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase, and total bilirubin) as a baseline before initiating febuxostat.
Measure liver tests promptly in patients who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice.
In this clinical context, if the patient presents abnormal liver tests (ALT or AST greater than three times the upper limit of the reference range), interrupt febuxostat treatment while investigating the probable cause.
Permanently discontinue febuxostat if liver injury is confirmed, and no alternate etiology can be found.
Permanently discontinue febuxostat in patients who have serum ALT or AST greater than three times the reference range with serum total bilirubin greater than two times the reference range without alternative etiologies because they are at risk for severe drug-induced liver injury.
For patients with lesser elevations of serum ALT or bilirubin and with an alternate probable cause, treatment with febuxostat can be used with close monitoring.
5.4 Serious Skin Reactions Serious skin and hypersensitivity reactions, including Stevens-Johnson Syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS) and toxic epidermal necrolysis (TEN) have been reported postmarketing in patients taking febuxostat tablets.
Discontinue febuxostat tablets if serious skin reactions are suspected [see Patient Counseling Information (17) ].
Many of these patients had reported previous similar skin reactions to allopurinol.
Febuxostat tablets should be used with close monitoring in these patients.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

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 organogenesis from gestation Days 7 to 17, febuxostat was not teratogenic and did not affect fetal development or survival at exposures up to approximately 40 times the MRHD (on an AUC basis at maternal oral doses up to 48 mg/kg/day).
In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation Days 6 to 18, febuxostat was not teratogenic and did not affect fetal development at exposures up to approximately 51 times the MRHD (on an AUC basis at maternal oral doses up to 48 mg/kg/day).
In a pre-and postnatal development study in pregnant female rats dosed orally from gestation Day 7 through lactation Day 20, febuxostat had no effects on delivery or growth and development of offspring at a dose approximately 11 times the MRHD (on an AUC basis at a maternal oral dose of 12 mg/kg/day).
However, increased neonatal mortality and a reduction in neonatal body weight gain were observed in the presence of maternal toxicity at a dose approximately 40 times the MRHD (on an AUC basis at a maternal oral dose of 48 mg/kg/day).
Febuxostat crossed the placental barrier following oral administration to pregnant rats and was detected in fetal tissues.
IN SPECIFIC POPULATIONS Patients with severe hepatic impairment:
No studies have been conducted in this patient population.
Caution should be exercised in these patients.
(8.7) Patients with secondary hyperuricemia (including patients being treated for Lesch-Nyhan syndrome or malignant disease, or in organ transplant recipients):
Febuxostat is not recommended for use as no studies have been conducted in this patient population..
(8.8)
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 organogenesis from gestation Days 7 to 17, febuxostat was not teratogenic and did not affect fetal development or survival at exposures up to approximately 40 times the MRHD (on an AUC basis at maternal oral doses up to 48 mg/kg/day).
In an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation Days 6 to 18, febuxostat was not teratogenic and did not affect fetal development at exposures up to approximately 51 times the MRHD (on an AUC basis at maternal oral doses up to 48 mg/kg/day).
In a pre-and postnatal development study in pregnant female rats dosed orally from gestation Day 7 through lactation Day 20, febuxostat had no effects on delivery or growth and development of offspring at a dose approximately 11 times the MRHD (on an AUC basis at a maternal oral dose of 12 mg/kg/day).
However, increased neonatal mortality and a reduction in neonatal body weight gain were observed in the presence of maternal toxicity at a dose approximately 40 times the MRHD (on an AUC basis at a maternal oral dose of 48 mg/kg/day).
Febuxostat crossed the placental barrier following oral administration to pregnant rats and was detected in fetal tissues.
8.2 Lactation 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.
Febuxostat is present in rat milk.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for febuxostat and any potential adverse effects on the breastfed child from febuxostat or from the underlying maternal condition.
Data Animal Data Orally administered febuxostat was detected in the milk of lactating rats at up to approximately 7 times the plasma concentration.
8.4 Pediatric Use Safety and effectiveness of febuxostat in pediatric patients have not been established.
8.5 Geriatric Use No dose adjustment is necessary in elderly patients.
Of the total number of patients in Studies 1, 2, and 3 (clinical studies of febuxostat in the treatment of gout) [see Clinical Studies (14.1) ], 16% were 65 and over, while 4% were 75 and over.
Comparing patients in different age groups, no clinically significant differences in safety or effectiveness were observed but greater sensitivity of some older individuals cannot be ruled out.
The C max and AUC 24 of febuxostat following multiple oral doses of febuxostat in geriatric patients (≥65 years) were similar to those in younger patients (18 to 40 years) [see Clinical Pharmacology (12.3) ].
8.6 Renal Impairment No dose adjustment is necessary in patients with mild to moderate renal impairment (Cl cr 30 to 89 mL/min).
For patients with severe renal impairment (Cl cr 15 to 29 mL/min), the recommended dosage of febuxostat is limited to 40 mg once daily [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) ].
8.7 Hepatic Impairment No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B).
No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C); therefore, caution should be exercised in these patients [see Clinical Pharmacology (12.3) ].
8.8 Secondary Hyperuricemia No studies have been conducted in patients with secondary hyperuricemia (including organ transplant recipients); febuxostat is not recommended for use in patients whom the rate of urate formation is greatly increased (e.g., malignant disease and its treatment, Lesch-Nyhan syndrome).
The concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

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.
Febuxostat is contraindicated in patients being treated with azathioprine or mercaptopurine [see Contraindications (4) ].
7.2 Cytotoxic Chemotherapy Drugs Drug interaction studies of febuxostat with cytotoxic chemotherapy have not been conducted.
No data are available regarding the safety of febuxostat during cytotoxic chemotherapy.
7.3 In Vivo Drug Interaction Studies Based on drug interaction studies in healthy patients, febuxostat does not have clinically significant interactions with colchicine, naproxen, indomethacin, hydrochlorothiazide, warfarin or desipramine [see Clinical Pharmacology (12.3) ].
Therefore, febuxostat may be used concomitantly with these medications.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Febuxostat was studied in healthy patients in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities.
No overdose of febuxostat was reported in clinical studies.
Patients should be managed by symptomatic and supportive care should there be an overdose.

Quoted from the official label, section “Overdosage”.

Use in children

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

Quoted from the official label, section “Pediatric Use”.

Use in older people

No dose adjustment is necessary in elderly patients.
Of the total number of patients in Studies 1, 2, and 3 (clinical studies of febuxostat in the treatment of gout) [see Clinical Studies (14.1) ], 16% were 65 and over, while 4% were 75 and over.
Comparing patients in different age groups, no clinically significant differences in safety or effectiveness were observed but greater sensitivity of some older individuals cannot be ruled out.
The C max and AUC 24 of febuxostat following multiple oral doses of febuxostat in geriatric patients (≥65 years) were similar to those in younger patients (18 to 40 years) [see Clinical Pharmacology (12.3) ].

Quoted from the official label, section “Geriatric Use”.

Side effects

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 Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 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.
For febuxostat 80 mg, 1377 patients were treated for ≥6 months, 674 patients were treated for ≥1 year and 515 patients were treated for ≥2 years.
In the CARES study, a total of 3098 patients were treated with febuxostat 40 mg or 80 mg daily; of these, 2155 patients were treated for ≥1 year and 1539 were treated for ≥2 years [see Clinical Studies (14.2) ].
Most Common Adverse Reactions In three randomized, controlled clinical studies (Studies 1, 2 and 3), which were 6 to 12 months in duration, the following adverse reactions were reported by the treating physician as related to study drug.
Table 1 summarizes adverse reactions reported at a rate of at least 1% in febuxostat treatment groups and at least 0.5% greater than placebo.
Table 1:
Adverse Reactions Occurring in ≥1% of Patients Treated with Febuxostat and at Least 0.5% Greater than in Patients Receiving Placebo in Controlled Studies Adverse Reactions Placebo Febuxostat allopurinol Of the patients who received allopurinol, 10 received 100 mg, 145 received 200 mg, and 1122 received 300 mg, based on level of renal impairment.
(N=134) 40 mg daily (N=757) 80 mg daily (N=1279) (N=1277) Liver Function Abnormalities 0.7% 6.6% 4.6% 4.2% Nausea 0.7% 1.1% 1.3% 0.8% Arthralgia 0% 1.1% 0.7% 0.7% Rash 0.7% 0.5% 1.6% 1.6% The most common adverse reaction leading to discontinuation from therapy was liver function abnormalities in 1.8% of febuxostat 40 mg, 1.2% of febuxostat 80 mg, and in 0.9% of patients treated with allopurinol.
In addition to the adverse reactions presented in Table 1, dizziness was reported in more than 1% of patients treated with febuxostat although not at a rate more than 0.5% greater than placebo.
In the CARES study, liver function abnormalities and diarrhea were reported in more than 1% of patients treated with febuxostat, although not at a rate more than 0.5% greater than allopurinol.
Less Common Adverse Reactions In clinical studies the following adverse reactions occurred in less than 1% of patients and in more than one subject treated with doses ranging from 40 mg to 240 mg of febuxostat.
This list also includes adverse reactions (less than 1% of patients) associated with organ systems from Warnings and Precautions.
Blood and Lymphatic System Disorders :
anemia, idiopathic thrombocytopenic purpura, leukocytosis/leukopenia, neutropenia, pancytopenia, splenomegaly, thrombocytopenia.
Cardiac Disorders :
angina pectoris, atrial fibrillation/flutter, cardiac murmur, ECG abnormal, palpitations, sinus bradycardia, tachycardia.
Ear and Labyrinth Disorders : deafness, tinnitus, vertigo.
Eye Disorders : vision blurred.
Gastrointestinal Disorders :
abdominal distention, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, frequent stools, gastritis, gastroesophageal reflux disease, gastrointestinal discomfort, gingival pain, hematemesis, hyperchlorhydria, hematochezia, mouth ulceration, pancreatitis, peptic ulcer, vomiting.
General Disorders and Administration Site Conditions :
asthenia, chest pain/discomfort, edema, fatigue, feeling abnormal, gait disturbance, influenza-like symptoms, mass, pain, thirst.
Hepatobiliary Disorders :
cholelithiasis/cholecystitis, hepatic steatosis, hepatitis, hepatomegaly.
Immune System Disorder : hypersensitivity.
Infections and Infestations : herpes zoster.
Procedural Complications : contusion.
Metabolism and Nutrition Disorders :
anorexia, appetite decreased/increased, dehydration, diabetes mellitus, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, hypokalemia, weight decreased/increased.
Musculoskeletal and Connective Tissue Disorders :
arthritis, joint stiffness, joint swelling, muscle spasms/twitching/tightness/weakness, musculoskeletal pain/stiffness, myalgia.
Nervous System Disorders :
altered taste, balance disorder, cerebrovascular accident, Guillain-Barré syndrome, headache, hemiparesis, hypoesthesia, hyposmia, lacunar infarction, lethargy, mental impairment, migraine, paresthesia, somnolence, transient ischemic attack, tremor.
Psychiatric Disorders :
agitation, anxiety, depression, insomnia, irritability, libido decreased, nervousness, panic attack, personality change.
Renal and Urinary Disorders :
hematuria, nephrolithiasis, pollakiuria, proteinuria, renal failure, renal insufficiency, urgency, incontinence.
Reproductive System and Breast Changes : breast pain, erectile dysfunction, gynecomastia.
Respiratory, Thoracic and Mediastinal Disorders :
bronchitis, cough, dyspnea, epistaxis, nasal dryness, paranasal sinus hypersecretion, pharyngeal edema, respiratory tract congestion, sneezing, throat irritation, upper respiratory tract infection.
Skin and Subcutaneous Tissue Disorders :
alopecia, angioedema, dermatitis, dermographism, ecchymosis, eczema, hair color changes, hair growth abnormal, hyperhidrosis, peeling skin, petechiae, photosensitivity, pruritus, purpura, skin discoloration/altered pigmentation, skin lesion, skin odor abnormal, urticaria.
Vascular Disorders : flushing, hot flush, hypertension, hypotension.
Laboratory Parameters:
activated partial thromboplastin time prolonged, creatine increased, bicarbonate decreased, sodium increased, EEG abnormal, glucose increased, cholesterol increased, triglycerides increased, amylase increased, potassium increased, TSH increased, platelet count decreased, hematocrit decreased, hemoglobin decreased, MCV increased, RBC decreased, creatinine increased, blood urea increased, BUN/creatinine ratio increased, creatine phosphokinase (CPK) increased, alkaline phosphatase increased, LDH increased, PSA increased, urine output increased/decreased, lymphocyte count decreased, neutrophil count decreased, WBC increased/decreased, coagulation test abnormal, low density lipoprotein (LDL) increased, prothrombin time prolonged, urinary casts, urine positive for white blood cells and protein.
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of febuxostat.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders: agranulocytosis, eosinophilia.
Hepatobiliary Disorders:
hepatic failure (some fatal), jaundice, serious cases of abnormal liver function test results, liver disorder.
Immune System Disorders: anaphylaxis, anaphylactic reaction.
Musculoskeletal and Connective Tissue Disorders: rhabdomyolysis.
Psychiatric Disorders: psychotic behavior including aggressive thoughts.
Renal and Urinary Disorders: tubulointerstitial nephritis.
Skin and Subcutaneous Tissue Disorders:
generalized rash, Stevens-Johnson Syndrome, hypersensitivity skin reactions, erythema multiforme, drug reaction with eosinophilia and systemic symptoms, toxic epidermal necrolysis.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

Advise the patient to read the FDA-approved patient labeling (Medication Guide) .
CV Death Inform patients that gout patients with established CV disease treated with febuxostat tablets had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study.
Inform all patients of the higher rate of CV death with febuxostat tablets compared to allopurinol.
Alert all patients (those with and without CV disease) for the development of signs and symptoms of CV events and to seek medical care promptly should they occur [see Warnings and Precautions (5.1) ].
Gout Flares Inform patients that after initiation of febuxostat tablets an increase in gout flares can occur and that is not reason to stop taking the medication.
Instruct patients that it is recommended to initiate and continue gout prophylaxis therapy for six months while taking febuxostat tablets [see Warnings and Precautions (5.2) ].
Hepatic Effects Inform patients that hepatic effects, including fatal ones, have occurred in patients treated with febuxostat tablets.
Instruct them to inform their healthcare provider if they experience liver injury symptoms [see Warnings and Precautions (5.3) ].
Serious Skin Reactions Inform patients that serious skin and hypersensitivity reactions have occurred in patients treated with febuxostat tablets.
Instruct patients to discontinue febuxostat tablets if they develop symptoms of these reactions [see Warnings and Precautions (5.4) ].
Dispense with Medication Guide.
To order more Medication Guides call American Health Packaging at 1‐800‐707‐4621.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

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 with ‘722’ debossed on one side and plain on other side.
Tablet: 40 mg, 80 mg.
(3)

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

Febuxostat 40 mg tablets are round, biconvex, green colored, film-coated tablets with ‘721’ debossed on one side and plain on other side and supplied as:
Unit dose packages of 30 (3 x 10) NDC 60687-538-21 Protect from light.
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Quoted from the official label, section “How Supplied”.

What is in it

Febuxostat is a xanthine oxidase inhibitor.
The active ingredient in febuxostat tablets is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid, with a molecular weight of 316.38.
The molecular formula is C 16 H 16 N 2 O 3 S.
The chemical structure is:
Febuxostat is a non-hygroscopic, white to off white crystalline powder that is freely soluble in dimethylformamide; soluble in dimethylsulphoxide; sparingly soluble in ethanol; slightly soluble in methanol and acetonitrile; and practically insoluble in water.
The melting range is 200°C to 202°C.
Febuxostat tablets for oral use contain the active ingredient, febuxostat, and are available in two dosage strengths, 40 mg and 80 mg.
Inactive ingredients include microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, sodium lauryl sulfate, hydroxypropyl cellulose, croscarmellose sodium and magnesium stearate.
Febuxostat tablets are coated with polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake and iron oxide yellow.
Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (24)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 24 of 24

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

European UnionNo exact match for this strength and form

Every strength and form (3)

SpainNo exact match for this strength and form

Every strength and form (53)

CanadaNo exact match for this strength and form

Every strength and form (1)

NetherlandsNo exact match for this strength and form

Every strength and form (10)

Details

Made by	American Health Packaging
Active substance	Febuxostat
Used in	Muscles, joints and bones
Strength	40 mg
Form	Tablet, Film Coated
Route	Oral
Packs	30 BLISTER PACK in 1 BOX, UNIT-DOSE / 1 TABLET, FILM COATED in 1 BLISTER PACK
NDC	60687-538

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

43 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Tablet23 products
- 40 mg13
  40 mg · 13 companies
  +5 more
- 80 mg10
  80 mg · 10 companies
  +2 more
Tablet, Film Coated14 products
- 40 mg8
  40 mg · 8 companies
  - American Health Packaging · this page
  - Aphena Pharma Solutions - Tennessee, LLC
  - Ascend Laboratories, LLC
  - MAJOR PHARMACEUTICALS
  - NorthStar RxLLC
  - Novadoz Pharmaceuticals LLC
  - NuCare Pharmaceuticals,Inc.
  - Sun Pharmaceutical Industries, Inc.
- 80 mg6
  80 mg · 6 companies
Tablet, Coated4 products
- 40 mg2
  40 mg · 2 companies
  - Alembic Pharmaceuticals Inc.
  - Alembic Pharmaceuticals Limited
- 80 mg2
  80 mg · 2 companies
  - Alembic Pharmaceuticals Inc.
  - Alembic Pharmaceuticals Limited
Film2 products
- 40 mg
- 80 mg

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Febuxostat40 mgPrescription onlyTablet Hikma Pharmaceuticals USA Inc · Febuxostat Febuxostat80 mgPrescription onlyTablet Hikma Pharmaceuticals USA Inc · Febuxostat Febuxostat40 mgPrescription onlyTablet Lannett Company, Inc. · Febuxostat Febuxostat80 mgPrescription onlyTablet Lannett Company, Inc. · Febuxostat Febuxostat40 mgPrescription onlyTablet, Film Coated MAJOR PHARMACEUTICALS · Febuxostat Febuxostat80 mgPrescription onlyTablet, Film Coated MAJOR PHARMACEUTICALS · Febuxostat

See every product with Febuxostat