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Febuxostat 80 mg Tablet, Coated, 100-count

by Alembic Pharmaceuticals Inc. · 100 TABLET, COATED in 1 BOTTLE (62332-191-31)

NDC 62332-0191-31

🏷️ FDA NDC (as labeled) 62332-191-31 billing pads the product segment with a zero

This package

Contains100-count Pack sizes5 compare ↓

Also priced by: Part D plans $0.7479/unit — full pricing hub ↓

Also comes in: 30 tablets 62332-0191-30 60 tablets 62332-0191-06 100 tablets 62332-0191-10 1000 tablets 62332-0191-91

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️

Other active recalls for Febuxostat (different manufacturers) — 2 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · Mar 4, 2024 — CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0369-2024

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 62332-191-31

Product NDC 62332-191

11-digit billing NDC 62332019131

RxCUI 834235, 834241

UNII 101V0R1N2E

UPC 0362332191307

Application # ANDA205421

SPL Set ID 9a87099f-d82d-42c7-872a-b87d3917e960

Established class (EPC) Xanthine Oxidase Inhibitor

Mechanism of action Xanthine Oxidase Inhibitors

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2019-07-01

Route ORAL

Dosage form TABLET, COATED

Substance FEBUXOSTAT

GPI-14 68000030000330

GPI class Febuxostat

GCN Seq No 064830

GCN 16809

HICL code 036106

Ingredient (HICL) Febuxostat

HIC1 code C

Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition

HIC2 code C7

Therapeutic class — intermediate (HIC2) Metabolic Inhibitors And Stimulants

HIC3 code C7A

Therapeutic class — specific (HIC3) Hyperuricemia Tx - Xanthine Oxidase Inhibitors

AHFS code 92:16.00.00

AHFS class Antigout Agents

FDB label name FEBUXOSTAT 80 MG TABLET

FDB brand name Febuxostat

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 62332-191-31 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62332-0191-31. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Xanthine Oxidase Inhibitor class.

Pharmacologic class Xanthine Oxidase Inhibitor

Drug family (ATC) Preparations inhibiting uric acid production

How it works Xanthine Oxidase Inhibitors

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAlembic Pharmaceuticals Inc.

Application holderALEMBIC PHARMACEUTICALS LTD

FDA applicationANDA205421 (ANDA)

Labeler code62332

First marketedJul 2019

Product typeHuman Prescription Drug

Portfolio491 products on file

🔎 All NDCs from Alembic Pharmaceuticals Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name FEBUXOSTAT 80 MG TABLET Ingredient Febuxostat

📖 What it is MedlinePlus · NLM

Febuxostat is used to treat gout in adults who were not treated successfully with or who are not able to take allopurinol (Aloprim, Zyloprim). Gout is a type of arthritis in which uric acid, a naturally occurring substance in the body, builds up in the joints and causes sudden attacks of redness, swelling, pain, and heat in one or more joints. Febuxostat is in a class of medications called xanthine oxidase inhibitors. It works by decreasing the amount of uric acid that is made in the body. Febuxostat is used to prevent gout attacks but not to treat them once they occur.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

You're right that allopurinol is typically tried first for gout. Febuxostat is specifically approved for people who haven't responded well enough to allopurinol at the highest tole...
Why am I on febuxostat instead of allopurinol — isn't allopurinol the usual gout medicine?
This is actually very common and completely expected in the early weeks. When febuxostat starts lowering your uric acid, it stirs up deposits that have built up in your joints, whi...
My gout attacks are actually getting worse since I started this medicine. Is something wrong?

📖 Read our full Febuxostat guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Febuxostat — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Febuxostat (56 interactions) — ranked by severity →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Green

ShapeTear

ImprintL441

Size14 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
UNII UKE75GEA7F
Hydroxypropyl cellulose is a plant-based polymer used as a binder and thickener. It helps hold tablet ingredients together, controls how fast the medicine dissolves, and improves the texture of liquid formulations.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII SA1B764746
A synthetic polymer commonly used as a solvent and binder in medicines. It helps dissolve active ingredients, improve texture, and ensure consistent tablet or capsule formation.
UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

13 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$0.7479	$74.79 / 100 tablets

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Febuxostat 80 mg 00054-0414-13	Hikma	30 tablets	$0.281	AB	Availability likely	—
Febuxostat 80 mg 00527-2248-32	Lannett	30 tablets	$0.281	AB	Availability likely	—
Febuxostat 80 mg 00904-7396-46	MAJOR	30 tablets	$0.281	AB	Availability likely	—
Febuxostat 80 mg 00904-7485-03	Major	30 tablets	$0.281	AB	Discontinued	—
Febuxostat 80 mg 16714-0060-01	NorthStar	30 tablets	$0.281	AB	Availability likely	—
Febuxostat 80 mg 27808-0207-01	Tris	30 tablets	$0.281	AB	Availability likely	—
Febuxostat 80 mg 33342-0275-07	Macleods	30 films	$0.281	AB	Availability likely	—
Febuxostat 80 mg 43547-0296-03	Solco	30 tablets	$0.281	AB	Availability likely	—
Febuxostat 80 mg 72205-0029-30	Novadoz	30 tablets	$0.281	AB	Availability likely	—
Febuxostat 80 mg 46708-0191-06	Alembic	60 tablets	—	AB	FDA listed	—
Febuxostat 80 mg 47335-0722-18	Sun	1000 tablets	—	AB	FDA listed	—
Febuxostat 80 mg 51407-0294-30	Golden	30 tablets	—	AB	FDA listed	—
Febuxostat 80 mg 55111-0797-01	DR	100 tablets	—	AB	FDA listed	—
Febuxostat 80 mg 59651-0114-01	Aurobindo	100 tablets	—	AB	FDA listed	—
Febuxostat 80 mgthis 62332-0191-31	Alembic	100 tablets	—	AB	FDA listed	—
Uloric 80 mg 64764-0677-11	Takeda	100 tablets	—	AB	FDA listed	—
Febuxostat 80 mg 67877-0669-01	Ascend	100 tablets	—	AB	FDA listed	—
Febuxostat 80 mg 68071-3761-09	NuCare	90 tablets	—	AB	FDA listed	—
febuxostat 80 mg 70771-1553-00	Zydus	1000 tablets	—	AB	FDA listed	—
Febuxostat 80 mg 72303-0856-01	HEC	30 tablets	—	AB	FDA listed	—
febuxostat 80 mg 72578-0137-01	Viona	100 tablets	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2019

On the market since

Jul 2019

📍

2026

Currently FDA-listed

7 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

30 tablets62332-0191-30 2,706 Rx · $111,525

60 tablets62332-0191-06 No Medicaid data

100 tablets62332-0191-10 No Medicaid data

100 tablets this page62332-0191-31 No Medicaid data

1000 tablets62332-0191-91 No Medicaid data

Drug total (last 4 qtrs): 2,706 Rx · 112,055 units · $111,525 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Febuxostat — the program that covers self-administered drugs. 13 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Febuxostat. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$5.54M

Claims incl. refills

87.2K

Beneficiaries

60.3K

Spend / beneficiary

$92.00

Spend / claim

$63.59

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Febuxostat — the ingredient across all brands.

Top reported reactions

Diarrhoea881

Acute Kidney Injury857

Nausea857

Rash800

Gout699

Dyspnoea640

Fatigue619

Age at onset

Neonate1

Child2

Adolescent4

Adult1,113

Elderly2,196

Reporter sex

Male · 67%

Female · 32%

Unknown · 1%

Serious outcomes

Hospitalization7,176

Death2,180

Life-threatening1,050

Disabling623

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
62332-0191-06	60 TABLET, COATED in 1 CARTON (62332-191-06)	—	—	2019-07-01	Active
62332-0191-10	100 TABLET, COATED in 1 CARTON (62332-191-10)	—	—	2019-07-01	Active
62332-0191-30	30 TABLET, COATED in 1 BOTTLE (62332-191-30)	$0.2810 / ea	$8.43	2019-07-01	Active
62332-0191-31 You're viewing this	100 TABLET, COATED in 1 BOTTLE (62332-191-31)	—	—	2019-07-01	Active
62332-0191-91	1000 TABLET, COATED in 1 BOTTLE (62332-191-91)	—	—	2019-07-01	Active

This pack shows little to no recent Medicaid volume — the 30 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 62332-0191-31?

NDC 62332-0191-31 is a 100-count package — 100 tablet, coated in 1 bottle.

What is the difference between NDC 62332-0191-31 and NDC 62332-0191-30?

Both are Febuxostat 80 mg Tablet, Coated — the drug itself is identical. NDC 62332-0191-31 is the 100-count package, while NDC 62332-0191-30 is the 30 tablets package.

What NDC number is used to bill for this package of Febuxostat 80 mg Tablet, Coated?

Bill NDC 62332-0191-31 — the 11-digit billing format is 62332019131. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 62332-191-31, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 62332-0191-31, written without dashes as 62332019131. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 62332-0191-31, the first segment (62332) is the labeler code FDA assigned to Alembic Pharmaceuticals Inc.; the middle segment (0191) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (31) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Alembic Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 4 other package presentations of this same product, including 30 tablets (62332-0191-30), 60 tablets (62332-0191-06), 100 tablets (62332-0191-10). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Alembic Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning 188 words ▾

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)]. 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)

🎯 Indications and Usage 125 words ▾

1 INDICATIONS AND USAGE 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. Limitations of Use : Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. 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) Limitations of Use: Febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. (1)

⏱️ Dosage and Administration ~2 min read ▾

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 tablet. (2.4) • Can be administered without regard to food or antacid use.

(2.1)

2.1Recommended Dosage The recommended febuxostat tablet dosage is 40 mg or 80 mg once daily. The recommended starting dosage of febuxostat tablet 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 tablet 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)].

2.2Dosage Recommendations in Patients with Renal Impairment and Hepatic Impairment The recommended dosage of febuxostat tablet is limited to 40 mg once daily in patients with severe renal impairment. No dose modification is necessary when administering febuxostat tablet 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)] .

2.3Serum 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 tablets therapy.

2.4Recommended Prophylaxis for Gout Flares Gout flares may occur after initiation of febuxostat tablets 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 tablets. Prophylactic therapy may be beneficial for up to six months [see Clinical Studies ( 14.1)] .

If a gout flare occurs during febuxostat tablets treatment, febuxostat tablets need not be discontinued. The gout flare should be managed concurrently, as appropriate for the individual patient [see Warnings and Precautions ( 5.2)] .

💊 Dosage Forms and Strengths 57 words ▾

3 DOSAGE FORMS AND STRENGTHS 40 mg tablets, light green to green, round, biconvex, film-coated tablets debossed with L440 on one side and plain on other side 80 mg tablets, light green to green, tear drop shaped, biconvex film-coated tablets debossed with L441 on one side and plain on other side. Tablet: 40 mg, 80 mg. (3)

⛔ Contraindications 33 words ▾

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)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Gout Flares: An increase in gout flares is frequently observed after initiation of febuxostat tablets. If a gout flare occurs during treatment, febuxostat tablets 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 tablets and treat cause, if possible, to resolution or stabilization. Permanently discontinue febuxostat tablets 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 tablets. Discontinue febuxostat tablets if serious skin reactions are suspected. (5.4)

5.1Cardiovascular 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 the risks and benefits of febuxostat tablets when deciding to prescribe or continue patients on febuxostat tablets. 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.

5.2Gout Flares After initiation of febuxostat tablets, 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 tablets are initiated, concurrent prophylactic treatment with an NSAID or colchicine is recommended [see Dosage and Administration (2.4)].

5.3Hepatic Effects Cases of fatal and nonfatal hepatic failure in patients taking febuxostat tablets 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 tablets 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 tablets. 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 tablets treatment while investigating the probable cause.

Permanently discontinue febuxostat tablets if liver injury is confirmed, and no alternate etiology can be found. Permanently discontinue febuxostat tablets in patients who have serum ALT or AST greater than three times the reference range…

🤒 Adverse Reactions ~3 min read ▾

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 occurring in ≥ 1% of patients treated with febuxostat tablets are liver function abnormalities, nausea, arthralgia, and rash. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 tablets 40 mg or 80 mg daily. For febuxostat tablets 40 mg, 559 patients were treated for ≥6 months.

For febuxostat tablets 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 tablets 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 six 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 tablets treatment groups and at least 0.5% greater than placebo. Table 1: Adverse Reactions Occurring in ≥ 1% of Patients Treated with Febuxostat Tablets and at Least 0.5% Greater than in Patients Receiving Placebo in Controlled Studies Adverse Reactions Placebo Febuxostat Tablets allopurinol* (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% * 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.

The most common adverse reaction leading to discontinuation from therapy was liver function abnormalities in 1.8% of febuxostat tablets 40 mg, 1.2% of febuxostat tablets 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 tablets 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 tablets, 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 tablets. 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 dis…

🔄 Drug Interactions 209 words ▾

7 DRUG INTERACTIONS Concomitant administration of febuxostat tablets with XO substrate drugs, azathioprine or mercaptopurine could increase plasma concentrations of these drugs resulting in severe toxicity. (7)

7.1Xanthine 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 tablets 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 tablets with other drugs that are metabolized by XO (e.g., mercaptopurine) have not been conducted. Febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see Contraindications (4)].

7.2Cytotoxic Chemotherapy Drugs Drug interaction studies of febuxostat tablets with cytotoxic chemotherapy have not been conducted. No data are available regarding the safety of febuxostat tablets during cytotoxic chemotherapy.

7.3In Vivo Drug Interaction Studies Based on drug interaction studies in healthy patients, febuxostat tablets do not have clinically significant interactions with colchicine, naproxen, indomethacin, hydrochlorothiazide, warfarin or desipramine [see Clinical Pharmacology (12.3)]. Therefore, febuxostat tablets may be used concomitantly with these medications.

👥 Use in Specific Populations ~3 min read ▾

8 USE 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 tablets are not recommended for use as no studies have been conducted in this patient population. (8.8)

8.1Pregnancy Risk Summary Limited available data with febuxostat tablets 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.

8.2Lactation 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.

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

8.5Geriatric 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 tablets 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 in…

🤰 Pregnancy ~2 min read ▾

Febuxostat crossed the placental barrier following oral administration to pregnant rats and was detected in fetal tissues.

🧒 Pediatric Use 16 words ▾

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

🧓 Geriatric Use 111 words ▾

The C max and AUC 24 of febuxostat following multiple oral doses of febuxostat tablets in geriatric patients (≥65 years) were similar to those in younger patients (18 to 40 years) [see Clinical Pharmacology (12.3)].

🆘 Overdosage 48 words ▾

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

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Febuxostat tablet, a xanthine oxidase inhibitor, achieves its therapeutic effect by decreasing serum uric acid. Febuxostat tablet is not expected to inhibit other enzymes involved in purine and pyrimidine synthesis and metabolism at therapeutic concentrations.

12.2Pharmacodynamics Effect on Uric Acid and Xanthine Concentrations In healthy patients, febuxostat tablets resulted in a dose dependent decrease in 24-hour mean serum uric acid concentrations and an increase in 24- hour mean serum xanthine concentrations. In addition, there was a decrease in the total daily urinary uric acid excretion. Also, there was an increase in total daily urinary xanthine excretion.

Percent reduction in 24-hour mean serum uric acid concentrations was between 40% and 55% at the exposure levels of 40 mg and 80 mg daily doses. Effect on Cardiac Repolarization The effect of febuxostat tablets on cardiac repolarization as assessed by the QTc interval was evaluated in normal healthy patients and in patients with gout. Febuxostat tablets in doses up to 300 mg daily (3.75 times the maximum recommended daily dosage), at steady-state, did not demonstrate an effect on the QTc interval.

12.3Pharmacokinetics In healthy patients, maximum plasma concentrations (C max ) and AUC of febuxostat increased in a dose proportional manner following single and multiple doses of 10 mg (0.25 times the lowest recommended dosage) to 120 mg (1.5 times the maximum recommended dosage). There is no accumulation when therapeutic doses are administered every 24 hours. Febuxostat has an apparent mean terminal elimination half-life ( t1/2 ) of approximately 5 to 8 hours.

Febuxostat pharmacokinetic parameters for patients with hyperuricemia and gout estimated by population pharmacokinetic analyses were similar to those estimated in healthy patients. Absorption The absorption of radiolabeled febuxostat following oral dose administration was estimated to be at least 49% (based on total radioactivity recovered in urine). Maximum plasma concentrations of febuxostat occurred between 1 and 1.5 hours postdose.

After multiple oral 40 mg and 80 mg once daily doses, C max is approximately 1.6 ± 0.6 mcg/mL (N=30), and 2.6 ± 1.7 mcg/mL (N=227), respectively. Absolute bioavailability of the febuxostat tablet has not been studied. 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.

However, no clinically significant change in the percent decrease in serum uric acid concentration was observed (58% fed vs 51% fasting). Thus, febuxostat may be taken without regard to food. Concomitant ingestion of an antacid containing magnesium hydroxide and aluminum hydroxide with an 80 mg single dose of febuxostat tablet has been shown to delay absorption of febuxostat (approximately one hour) and to cause a 31% decrease in C max and a 15% decrease in AUC ∞ .

As AUC rather than C max was related to drug effect, change observed in AUC was not considered clinically significant. Therefore, febuxostat tablets may be taken without regard to antacid use. Distribution The mean apparent steady state volume of distribution (V ss /F) of febuxostat was approximately 50 L (CV ~40%).

The plasma protein binding of febuxostat is approximately 99.2% (primarily to albumin), and is constant over the concentration range achieved with 40 mg and 80 mg doses. 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. The relative contribution of each enzyme isoform in the metabolism of febuxostat is not clear.

The oxidation of the isobutyl side chain leads to the formation of four pharmacologically active hydroxy metabolites, all of which occur in plasma of humans at a much lower exten…

🧬 Mechanism of Action 39 words ▾

📦 How Supplied / Storage and Handling 175 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Febuxostat tablets are available in two strengths as 40 mg and 80 mg. 40 mg: Light green to green, round, biconvex, film-coated tablets debossed with L440 on one side and plain on other side. They are supplied as: NDC 62332-190-30 bottle of 30 units NDC 62332-190-31 bottle of 100 units NDC 62332-190-91 bottle of 1000 units NDC 62332-190-08 80 Tablets Carton of 80 (10 x 8) Unit-Dose Tablets NDC 62332-190-10 100 Tablets Carton of 100 (10 x 10) Unit-Dose Tablets 80 mg: Light green to green, tear drop shaped, biconvex film coated tablets debossed with L441 on one side and plain on other side and supplied as: NDC 62332-191-30 bottle of 30 units NDC 62332-191-31 bottle of 100 units NDC 62332-191-91 bottle of 1000 units NDC 62332-191-06 60 Tablets Carton of 60 (10 x 6) Unit-Dose Tablets NDC 62332-191-10 100 Tablets Carton of 100 (10 x 10) Unit-Dose Tablets Protect from light.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].

📋 Description 149 words ▾

11 DESCRIPTION Febuxostat is a xanthine oxidase inhibitor. The active ingredient in febuxostat tablet is 2-[3-cyano-4-(2-methylpropoxy) phenyl]-4-methylthiazole-5-carboxylic acid, with a molecular weight of 316.38. The empirical formula is C 16 H 16 N 2 O 3 S.

The chemical structure is: Febuxostat is a non-hygroscopic, white to off white powder that is freely soluble in N,N-dimethylformamide; soluble in dimethyl sulfoxide; sparingly soluble in ethanol; slightly soluble in methanol and acetonitrile; and practically insoluble in water. The melting range is 201°C to 208°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: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate and polyvinyl alcohol, talc, polyethylene glycol 3000, titanium dioxide, D&C yellow No. 10 aluminum Lake, FD&C blue No. 1 aluminum lake and FD&C blue No.

2 aluminum lake. Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION 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)] .

💬 Medication Guide ~3 min read ▾

Medication Guide Febuxostat (feb-UX-oh-stat) tablets, for oral use Read the Medication Guide that comes with febuxostat tablets before you start taking it and each time you get a refill. There may be new information. The Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment.

What is the most important information that I should know about febuxostat tablets? Febuxostat tablets may cause serious side effects, including: Heart-related deaths. Call your doctor or get emergency medical help right away if you have any of the following symptoms, especially if they are new, worse, or worry you: • chest pain • numbness or weakness on one side of your body • shortness of breath or trouble breathing • slurring of speech • dizziness, fainting or feeling lightheaded • sudden blurry vision or sudden severe headache • rapid or irregular heartbeat What are febuxostat tablets?

Febuxostat tablets are a prescription medicine called a xanthine oxidase (XO) inhibitor used to lower blood uric acid levels in adult patients with gout when allopurinol has not worked well enough or when allopurinol is not right for you. Febuxostat tablets are not for use in people who do not have symptoms of high blood uric acid levels. It is not known if febuxostat tablets are safe and effective in children.

Who should not take febuxostat tablets? Do not take febuxostat tablets if you: • take azathioprine (Azasan, Imuran) • take mercaptopurine (Purinethol, Purixan) What should I tell my doctor before taking febuxostat tablets? Before taking febuxostat tablets tell your doctor about all of your medical conditions, including if you: • have taken allopurinol and what happened to you while you were taking it. • have a history of heart disease or stroke. • have liver or kidney problems. • are pregnant or plan to become pregnant.

It is not known if febuxostat tablets will harm your unborn baby. Talk with your doctor if you are pregnant or plan to become pregnant. • are breastfeeding or plan to breastfeed. It is not known if febuxostat passes into your breast milk.

You and your doctor should decide if you should take febuxostat tablets while breastfeeding. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Febuxostat tablets may affect the way other medicines work, and other medicines may affect how febuxostat tablets works.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I take febuxostat tablets? • Take febuxostat tablets exactly as your doctor tells you to take it. • Febuxostat tablets can be taken with or without food. • Febuxostat tablets can be taken with antacids. • Your gout may get worse (flare) when you start taking febuxostat tablets.

Do not stop taking febuxostat tablets because you have a flare. Your doctor may do certain tests while you take febuxostat tablets. What are the possible side effects of febuxostat tablets?

Febuxostat tablets may cause serious side effects, including: • Heart problems. See “What is the most important information I should know about febuxostat tablets?”. • Gout Flares. Gout flares can happen when you start taking febuxostat tablets.

Your doctor may give you other medicines to help prevent your gout flares. • Liver problems. Liver problems can happen in people who take febuxostat tablets. Your doctor may do blood tests to check how well your liver is working before and during your treatment with febuxostat tablets.

Tell your doctor if you get any of the following signs or symptoms of liver problems: o fatigue o dark or “tea-colored” urine o loss of appetite for several days or longer o your skin or the white part of your eyes turns yellow (jaundice) o pain, aching, or tenderness on the right side of your stomach-area • Severe skin and allergic reactions. Serious skin and allergic reactions that may affect differe…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vivo: In a living person or animal rather than in a laboratory dish.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

angina pectoris: Chest pain or a squeezing feeling that happens when the heart muscle does not get enough blood and oxygen.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

arthralgia: Joint pain.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

atrial fibrillation: An irregular, often fast heart rhythm coming from the heart's upper chambers, which can raise the risk of blood clots.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

CYP1A2: A liver enzyme that breaks down certain medicines and whose activity can be changed by cigarette smoke.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

cytotoxic: Describing a substance that kills cells, especially fast-growing ones such as cancer cells.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

gastritis: Swelling or irritation of the lining of the stomach.

gastroesophageal reflux disease: Stomach acid flowing back up into the food pipe, causing heartburn and irritation.

gout: A type of arthritis with sudden, painful, swollen joints caused by uric acid crystals.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hyperuricemia: A higher-than-normal level of uric acid in the blood, which can lead to gout.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

leukocytosis: A higher-than-normal level of white blood cells, often a sign the body is fighting an infection.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

myocardial infarction: The medical term for a heart attack, when blood flow to part of the heart muscle is blocked.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

pancytopenia: A low level of all three main blood cell types at once: red cells, white cells, and platelets.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

purpura: Purple spots or patches on the skin caused by bleeding just under the surface.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

teratogenic: Able to cause physical birth defects in a developing baby when a medicine is taken during pregnancy.

thrombocytopenia: A low level of platelets, the blood cells that help form clots, which can lead to easier bruising or bleeding.

tinnitus: Ringing, buzzing, or other noise in the ears that is not coming from an outside sound.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

UGT: A family of enzymes that attach a sugar-like molecule to a drug, making it easier for the body to remove.

ULN: The highest value considered normal for a lab test; results above it are flagged as elevated.

upper limit of normal: The highest value considered normal for a lab test; results above it are flagged as elevated.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 62332-0190-08 · Alembic 62332-0192-08 · Alembic →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

Febuxostat 80 mg Tablet, Coated, 100-count

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