Is Febuxostat registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 17 valid registrations of Febuxostat, including AGOUT 120 mg film-coated tablets (120 mg, Film-coated tablet, SAR 106.00); AGOUT 40 mg film-coated tablets (40 mg, Film-coated tablet, SAR 106.00); AGOUT 80 mg film-coated tablets (80 mg, Film-coated tablet, SAR 106.00); Decryst (80 mg, Film-coated tablet, SAR 90.10); Decryst (40 mg, Film-coated tablet, SAR 90.10).

Is Febuxostat approved by the US FDA?

Drugs@FDA lists 16 application product lines for Febuxostat, including ULORIC (Prescription); FEBUXOSTAT (Prescription); FEBUXOSTAT (Prescription); FEBUXOSTAT (Prescription); FEBUXOSTAT (Prescription).

Is Febuxostat authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Febuxostat: Adenuric, Febuxostat Viatris (previously Febuxostat Mylan), Febuxostat Krka.

Are there safety signals or safety updates for Febuxostat?

EMA PRAC: 3 entries; US FDA: 1 entry; MHRA: 3 entries (latest 2023-05-25).

Active substance

Febuxostat

SFDA 18
US FDA 16
EMA 3
Health Canada 6
US price lines 4
NHS prices 2
Safety 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AGOUT 120 mg film-coated tablets	120 mg	Film-coated tablet · Oral use	30 Blister	SAR 106.00	Generic · Prescription	SPIMACO ADDWAEIH	Valid
AGOUT 40 mg film-coated tablets	40 mg	Film-coated tablet · Oral use	30 Blister	SAR 106.00	Generic · Prescription	SPIMACO ADDWAEIH	Valid
AGOUT 80 mg film-coated tablets	80 mg	Film-coated tablet · Oral use	30 Blister	SAR 106.00	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Decryst	80 mg	Film-coated tablet · Oral use	30 Blister	SAR 90.10	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Decryst	40 mg	Film-coated tablet · Oral use	30 Blister	SAR 90.10	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Donifoxate	80 mg	Film-coated tablet · Oral use	30 Blister	SAR 63.30	Generic · Prescription	Eva pharma for Industry	Valid
GOUTEX 40 mg film-coated tablet	40 mg	Film-coated tablet · Oral use	30 Blister	SAR 95.40	Generic · Prescription	DAMMAM PHARMA	Valid
GOUTEX 80 mg film-coated tablet	80 mg	Film-coated tablet · Oral use	30 Blister	SAR 95.40	Generic · Prescription	DAMMAM PHARMA	Valid
Resilia	80 mg	Film-coated tablet · Oral use	30 Blister	SAR 87.00	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Resilia	40 mg	Film-coated tablet · Oral use	30 Blister	SAR 87.00	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Urago	40 mg	Film-coated tablet · Oral use	30 Blister	SAR 90.10	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Urago	80 mg	Film-coated tablet · Oral use	30 Blister	SAR 90.10	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Uxorate	120 mg	Film-coated tablet · Oral use	28 Blister	SAR 84.10	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
Uxorate	80 mg	Film-coated tablet · Oral use	28 Blister	SAR 84.10	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
Uxorate	40 mg	Film-coated tablet · Oral use	30 Blister	SAR 90.10	Generic · Prescription	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
Zoxta	80 mg	Film-coated tablet · Oral use	30 Blister	SAR 63.60	Generic · Prescription	Savvy Pharma	Valid
Zoxta	40 mg	Film-coated tablet · Oral use	30 Blister	SAR 63.60	Generic · Prescription	Savvy Pharma	Valid
ADENURIC 80 mg film-coated tablet	80 mg	Film-coated tablet · Oral use	28 Blister	SAR 78.35	NCE · Prescription	Algorithm SAL	Suspended

Indications — CHI Daman Drug Formulary

BURKITT`S LYMPHOMA; CASTLEMAN DISEASE; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); DISORDERS OF PURINE AND PYRIMIDINE METABOLISM; FOLLICULAR LYMPHOMA; GOUT; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; RENAL AND URETERIC STONES; T-CELL LYMPHOMA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ULORIC	40MG; 80MG	tablet · oral	TAKEDA PHARMS USA	Prescription	13 Feb 2009
FEBUXOSTAT	40MG; 80MG	tablet · oral	ALEMBIC	Prescription	1 Jul 2019
FEBUXOSTAT	40MG; 80MG	tablet · oral	SUN PHARM	Prescription	1 Jul 2019
FEBUXOSTAT	40MG; 80MG	tablet · oral	HIKMA PHARMS	Prescription	15 Oct 2019
FEBUXOSTAT	40MG; 80MG	tablet · oral	REGCON HOLDINGS	Prescription	30 Dec 2019
FEBUXOSTAT	40MG; 80MG	tablet · oral	MSN	Prescription	30 Dec 2019
FEBUXOSTAT	40MG; 80MG	tablet · oral	SUNSHINE	Prescription	2 Jun 2020
FEBUXOSTAT	40MG; 80MG	tablet · oral	DR REDDYS	Prescription	22 Oct 2020
FEBUXOSTAT	40MG; 80MG	tablet · oral	ALKEM LABS LTD	Prescription	7 Dec 2021
FEBUXOSTAT	40MG; 80MG	tablet · oral	PRINSTON INC	Prescription	28 Mar 2022
FEBUXOSTAT	40MG; 80MG	tablet · oral	ZYDUS LIFESCIENCES	Prescription	9 Jan 2023
FEBUXOSTAT	40MG; 80MG	tablet · oral	MACLEODS PHARMS	Prescription	28 Sep 2023
FEBUXOSTAT	40MG; 80MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	25 Oct 2023
FEBUXOSTAT	40MG; 80MG	tablet · oral	PHARMOBEDIENT	Discontinued	1 Jul 2019
FEBUXOSTAT	40MG; 80MG	tablet · oral	TORRENT	Discontinued	19 Dec 2023
FEBUXOSTAT	40MG; 80MG	tablet · oral	LUPIN	Discontinued	17 Jan 2024

EMA European Union — centrally authorised medicines

Adenuric Menarini International Operations Luxembourg S.A. (MIOL) · Authorised · authorised 21 Apr 2008 · ATC M04AA03

Therapeutic indication (EMA)

80 mg strength: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuric is indicated in adults. 120 mg strength: Adenuric is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Adenuric is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). Adenuric is indicated in adults.

Febuxostat Viatris (previously Febuxostat Mylan) Viatris Limited · Authorised · authorised 15 Jun 2017 · ATC M04AA03

Therapeutic indication (EMA)

Febuxostat Viatris is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Viatris is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS). Febuxostat Viatris is indicated in adults.

Febuxostat Krka Krka, d.d., Novo mesto · Authorised · authorised 28 Mar 2019 · ATC M04AA03

Therapeutic indication (EMA)

Febuxostat Krka is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). Febuxostat Krka is indicated in adults.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AURO-FEBUXOSTAT	02533243	80 MG	TABLET · ORAL	AURO PHARMA INC
FEBUXOSTAT	02539837	80 MG	TABLET · ORAL	SANIS HEALTH INC
JAMP FEBUXOSTAT	02490870	80 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
M-FEBUXOSTAT	02549425	80 MG	TABLET · ORAL	MANTRA PHARMA INC
MAR-FEBUXOSTAT	02473607	80 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
TEVA-FEBUXOSTAT	02466198	80 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	FEBUXOSTAT 40 MG TABLET	$0.19115	per EA	23 Sep 2026
US NADAC	FEBUXOSTAT 80 MG TABLET	$0.26104	per EA	23 Sep 2026
US NADAC	ULORIC 40 MG TABLET	$10.54402	per EA	23 Sep 2026
US NADAC	ULORIC 80 MG TABLET	$10.53764	per EA	23 Sep 2026
NHS Drug Tariff	Febuxostat 120mg tablets	£3.65	28 tablet	1 Oct 2026
NHS Drug Tariff	Febuxostat 80mg tablets	£3.04	28 tablet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

MHRA 25 May 2023 Febuxostat: updated advice for the treatment of patients with a history of major cardiovascular disease
Caution is required if prescribing febuxostat in patients with pre-existing major cardiovascular disease, particularly, in those with evidence of high urate crystal and tophi burden or those initiating urate-lowering therapy.
US FDA 17 Apr 2023 ULORIC — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 17 Jul 2019 Febuxostat (Adenuric): increased risk of cardiovascular death and all-cause mortality in clinical trial in patients with a history of major cardiovascular disease
Avoid treatment with febuxostat in patients with pre-existing major cardiovascular disease (for example, myocardial infarction, stroke, or unstable angina), unless no other therapy options are appropriate. Findings from a phase 4 clinical study (the CARES study) in patients with gout and a history of major cardiovascular disease show a higher risk for cardiovascular-related death and for all-cause mortality in patients assigned to febuxostat than in those assigned to allopurinol.
EMA PRAC 16 May 2019 PRAC signal: Gynaecomastia
Action for MAH: update of the product information: No
MHRA 11 Dec 2014 Febuxostat (Adenuric▼): stop treatment if signs or symptoms of serious hypersensitivity
Febuxostat must be stopped immediately if hypersensitivity occurs and must not be re-started in patients who have ever developed a hypersensitivity reaction to febuxostat.
EMA PRAC 10 Jul 2014 PRAC signal: Potential drug-drug interaction between systemic tacrolimus and febuxostat
Action for MAH: update of the product information: No
EMA PRAC 6 Mar 2014 PRAC signal: Potential drug-drug interaction between systemic tacrolimus and febuxostat
Action for MAH: update of the product information: No

All safety entries for febuxostat →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.