Is Tofacitinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 12 valid registrations of Tofacitinib, including Jakenz (10 mg, Film-coated tablet, SAR 1676.85); Jakenz (5 mg, Film-coated tablet, SAR 1369.90); Timard (5 mg, Film-coated tablet, SAR 3090.20); Timard (10 mg, Film-coated tablet, SAR 3782.40); Tofaci (10 mg, Tablet, SAR 3593.25).

Is Tofacitinib approved by the US FDA?

Drugs@FDA lists 30 application product lines for Tofacitinib, including XELJANZ (Prescription); XELJANZ XR (Prescription); XELJANZ (Prescription); TOFACITINIB CITRATE (Prescription); TOFACITINIB CITRATE (Prescription).

Is Tofacitinib authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Tofacitinib: Xeljanz.

Are there safety signals or safety updates for Tofacitinib?

EMA PRAC: 9 entries; US FDA: 3 entries; MHRA: 3 entries (latest 2026-09-16).

Active substance

Tofacitinib

SFDA 12
US FDA 30
EMA 3
Health Canada 12
US price lines 5
Safety 15

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Jakenz	10 mg	Film-coated tablet · Oral use	28 Bottle	SAR 1676.85	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Jakenz	5 mg	Film-coated tablet · Oral use	28 Bottle	SAR 1369.90	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Timard	5 mg	Film-coated tablet · Oral use	60 Bottle	SAR 3090.20	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
Timard	10 mg	Film-coated tablet · Oral use	60 Bottle	SAR 3782.40	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
Tofaci	10 mg	Tablet · Oral use	60 Blister	SAR 3593.25	Generic · Prescription	Saudi Amarox	Valid
Tofaci	5 mg	Tablet · Oral use	60 Blister	SAR 2935.50	Generic · Prescription	Saudi Amarox	Valid
Tofanta	5 mg	Film-coated tablet · Oral use	60 Blister	SAR 2788.15	Generic · Prescription	Pharma Pharmaceutical Industries & Biological Products	Valid
Trijan	10 mg	Film-coated tablet · Oral use	56 Blister	SAR 3716.05	NCE · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Trijan	5 mg	Film-coated tablet · Oral use	60 Blister	SAR 3252.85	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
XELJANZ 10MG FILM COATED TABLETS	10 mg	Film-coated tablet · Oral use	60 Bottle	SAR 7186.90	NCE · Prescription	PFIZER INC	Valid
XELJANZ 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	60 Tablet Container	SAR 3485.15	NCE · Prescription	PFIZER	Valid
XELJANZ XR 11 mg Extended Release Tablet	11 mg	modified-release tablet · Oral use	30 Bottle	SAR 3485.15	NCE · Prescription	PFIZER	Valid

Indications — CHI Daman Drug Formulary

ANKYLOSING SPONDYLITIS; RHEUMATOID ARITHRITIS; ULCERATIVE COLITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
XELJANZ	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	PF PRISM CV	Prescription	6 Nov 2012
XELJANZ XR	EQ 11MG BASE; EQ 22MG BASE	tablet, extended release · oral	PFIZER	Prescription	23 Feb 2016
XELJANZ	EQ 1MG BASE/ML	solution · oral	PFIZER	Prescription	25 Sep 2020
TOFACITINIB CITRATE	EQ 10MG BASE	tablet · oral	AJANTA PHARMA LTD	Prescription	1 Jun 2021
TOFACITINIB CITRATE	EQ 11MG BASE; EQ 22MG BASE	tablet, extended release · oral	ZYDUS PHARMS	Prescription	19 Aug 2021
TOFACITINIB CITRATE	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	MICRO LABS	Prescription	13 Mar 2023
TOFACITINIB CITRATE	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	ZYDUS PHARMS	Prescription	14 Mar 2023
TOFACITINIB CITRATE	EQ 1MG BASE/ML	solution · oral	HIKMA PHARMS	Prescription	25 Sep 2023
TOFACITINIB CITRATE	EQ 11MG BASE	tablet, extended release · oral	AUROBINDO PHARMA LTD	Prescription	3 Jun 2024
TOFACITINIB CITRATE	EQ 11MG BASE	tablet, extended release · oral	DEXCEL	Prescription	16 Dec 2024
TOFACITINIB CITRATE	EQ 11MG BASE	tablet, extended release · oral	AJANTA PHARMA LTD	Prescription	19 Aug 2025
TOFACITINIB CITRATE	EQ 11MG BASE	tablet, extended release · oral	SINOTHERAPEUTICS INC	Prescription	30 Sep 2025
TOFACITINIB CITRATE	EQ 11MG BASE	tablet, extended release · oral	BIOCON PHARMA	Prescription	17 Nov 2025
TOFACITINIB CITRATE	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	BRECKENRIDGE	Prescription	3 Jun 2026
TOFACITINIB CITRATE	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	AUROBINDO PHARMA LTD	Prescription	3 Jun 2026
TOFACITINIB CITRATE	EQ 1MG BASE/ML	solution · oral	MSN	Prescription	3 Jun 2026
TOFACITINIB CITRATE	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	MSN	Prescription	3 Jun 2026
TOFACITINIB CITRATE	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	APOTEX	Prescription	3 Jun 2026
TOFACITINIB CITRATE	EQ 1MG BASE/ML	solution · oral	SUN PHARM INDS INC	Prescription	3 Jun 2026
TOFACITINIB CITRATE	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	SPECGX LLC	Prescription	3 Jun 2026
TOFACITINIB CITRATE	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	MACLEODS PHARMS	Prescription	3 Jun 2026
TOFACITINIB CITRATE	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	SOMERSET THERAPS LLC	Prescription	3 Jun 2026
TOFACITINIB CITRATE	EQ 11MG BASE	tablet, extended release · oral	APOTEX	Prescription	3 Jun 2026
TOFACITINIB CITRATE	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	YAOPHARMA CO LTD	Prescription	9 Jun 2026
TOFACITINIB CITRATE	EQ 5MG BASE; EQ 10MG BASE	tablet · oral	CONCORD BIOTECH LTD	Prescription	9 Jun 2026

5 more — full table

EMA European Union — centrally authorised medicines

Xeljanz Pfizer Europe MA EEIG · Authorised · authorised 22 Mar 2017 · ATC L04AF01

Therapeutic indication (EMA)

Rheumatoid arthritisTofacitinib in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs) (see section 5.1). Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5). Psoriatic arthritisTofacitinib in combination with MTX is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease modifying antirheumatic drug (DMARD) therapy (see section 5.1). Ulcerative colitisTofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5.1). Tofacitinib is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis), and juvenile psoriatic arthritis (PsA) in patients 2 years of age and older, who have responded inadequately to previous therapy with disease modifying antirheumatic drugs (DMARDs). Tofacitinib can be given in combination with methotrexate (MTX) or as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. Ankylosing spondylitisTofacitinib is indicated for the treatment of adult patients with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.

Xeljanz Pfizer Limited · Refused

Therapeutic indication (EMA)

Treatment of rheumatoid arthritis.

Inijaq Gedeon Richter Plc. · Opinion · ATC L04AF01

Therapeutic indication (EMA)

Treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis in adults, and juvenile idiopathic arthritis (JIA) in children from 2 years old

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AURO-TOFACITINIB	02530007	5 MG	TABLET · ORAL	AURO PHARMA INC
AURO-TOFACITINIB	02530015	10 MG	TABLET · ORAL	AURO PHARMA INC
JAMP TOFACITINIB	02522896	5 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
PMS-TOFACITINIB	02522799	5 MG	TABLET · ORAL	PHARMASCIENCE INC
SANDOZ TOFACITINIB	02551691	5 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ TOFACITINIB	02551705	10 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
TARO-TOFACITINIB	02511304	5 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TARO-TOFACITINIB	02511312	10 MG	TABLET · ORAL	TARO PHARMACEUTICALS INC
TARO-TOFACITINIB XR	02553988	11 MG	TABLET (EXTENDED-RELEASE) · ORAL	TARO PHARMACEUTICALS INC
XELJANZ	02423898	5 MG	TABLET · ORAL	PFIZER CANADA ULC
XELJANZ	02480786	10 MG	TABLET · ORAL	PFIZER CANADA ULC
XELJANZ XR	02470608	11 MG	TABLET (EXTENDED-RELEASE) · ORAL	PFIZER CANADA ULC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	TOFACITINIB 5 MG TABLET	$0.57264	per EA	30 Sep 2026
US NADAC	TOFACITINIB ER 11 MG TABLET	$2.19263	per EA	2 Sep 2026
US NADAC	XELJANZ 10 MG TABLET	$103.93842	per EA	23 Sep 2026
US NADAC	XELJANZ 5 MG TABLET	$73.77164	per EA	23 Sep 2026
US NADAC	XELJANZ XR 11 MG TABLET	$207.89619	per EA	23 Sep 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

US FDA 16 Sep 2026 XELJANZ — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 16 Sep 2026 XELJANZ — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 16 Sep 2026 XELJANZ XR — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 8 Jun 2023 PRAC signal: Acnes
Action for MAH: update of the product information: Yes
EMA PRAC 9 Feb 2023 PRAC signal: Acnes
Action for MAH: update of the product information: No
MHRA 6 Oct 2021 Tofacitinib (Xeljanz▼): new measures to minimise risk of major adverse cardiovascular events and malignancies
Tofacitinib should not be used in patients older than 65 years of age, people who are current or past smokers, or individuals with other cardiovascular (such as diabetes or coronary artery disease) or malignancy risk factors unless there are no suitable treatment alternatives.
EMA PRAC 10 Jun 2021 PRAC signal: Major adverse cardiovascular events (MACE) and malignancies excluding non-melanoma skin cancer (NMSC) from a clinical trial
Action for MAH: update of the product information: Yes
EMA PRAC 11 Mar 2021 PRAC signal: Major adverse cardiovascular events (MACE) and malignancies excluding non-melanoma skin cancer (NMSC) from a clinical trial
Action for MAH: update of the product information: No
EMA PRAC 3 Sep 2020 PRAC signal: Psychiatric disorders
Action for MAH: update of the product information: No
MHRA 18 Mar 2020 Tofacitinib (Xeljanz▼): new measures to minimise risk of venous thromboembolism and of serious and fatal infections
Caution should be used in patients with known risk factors for venous thromboembolism in addition to the underlying disease. Patients older than 65 years of age are at an increased risk of serious infections and should be treated with tofacitinib only if there is no alternative treatment.
MHRA 17 May 2019 Tofacitinib (Xeljanz▼): restriction of 10 mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing
Following observation in a clinical study of an increased risk of pulmonary embolism and overall mortality with tofacitinib 10 mg twice-daily in rheumatoid arthritis, a safety review has started and new contraindications introduced. The 10 mg twice-daily dose of tofacitinib (authorised for ulcerative colitis) must not be used in patients at high risk of pulmonary embolism.
EMA PRAC 16 May 2019 PRAC signal: Increased risk of pulmonary embolism and overall mortality arising from a post-authorisation safety study in patients with cardiovascular risk factors treated for rheumatoid arthritis with tofacitinib 10 mg twice daily
Action for MAH: update of the product information: No
EMA PRAC 15 Mar 2019 PRAC signal: Increased risk of pulmonary embolism and overall mortality arising from a post-authorisation safety study in patients with cardiovascular risk factors treated for rheumatoid arthritis with tofacitinib 10 mg twice daily
Action for MAH: update of the product information: No
EMA PRAC 30 Nov 2017 PRAC signal: Angioedema
Action for MAH: update of the product information: Yes
EMA PRAC 6 Jul 2017 PRAC signal: Angioedema
Action for MAH: update of the product information: No

All safety entries for tofacitinib →

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.