Is Methotrexate registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 23 valid registrations of Methotrexate, including Jylamvo (2 mg/ml, Oral solution, SAR 619.30); METHOTREXATE "EBEWE" 100MG-ML VIAL (100 mg/ml, Solution for injection, SAR 301.55); METHOTREXATE "EBEWE" 10MG-ML VIAL (10 mg/ml, Solution for injection, SAR 29.35); METHOTREXATE 1G-10ML INJ.FOR I.V OR I.M (100 mg/ml, Solution for injection, SAR 301.55); METHOTREXATE 2.5MG TAB. (2.5 mg, Tablet, SAR 51.60).

Is Methotrexate approved by the US FDA?

Drugs@FDA lists 77 application product lines for Methotrexate, including METHOTREXATE SODIUM (Prescription); METHOTREXATE SODIUM PRESERVATIVE FREE (Prescription); METHOTREXATE SODIUM PRESERVATIVE FREE (Prescription); METHOTREXATE SODIUM (Prescription); METHOTREXATE SODIUM (Prescription).

Is Methotrexate authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Methotrexate: Nordimet, Jylamvo.

Is Methotrexate on the WHO Model List of Essential Medicines?

Yes — 8.2.1. Cytotoxic medicines (complementary list): Lymphoid leukaemia, not elsewhere classified; Acute myeloid leukaemia with recurrent genetic abnormalities; Burkitt lymphoma including Burkitt leukaemia; Anaplastic large cell lymphoma, ALK-negative; Anaplastic large cell lymphoma, ALK-positive; Langerhans cell histiocytosis; Osteosarcoma of bone or articular cartilage of unspecified sites; Malignant neoplasms of breast; Malignant trophoblastic neoplasms of placenta.

Are there safety signals or safety updates for Methotrexate?

EMA PRAC: 11 entries; US FDA: 10 entries; MHRA: 1 entry (latest 2026-05-27).

Active substance

Methotrexate

SFDA 35
US FDA 77
EMA 2
Health Canada 50
US price lines 17
NHS prices 39
WHO EML 4
Safety 22

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Jylamvo	2 mg/ml	Oral solution · Oral use	1 Bottle	SAR 619.30	NCE · Prescription	Therakind (Europe) Limited	Valid
METHOTREXATE "EBEWE" 100MG-ML VIAL	100 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 301.55	Generic · Prescription	EBEWE PHARMA	Valid
METHOTREXATE "EBEWE" 100MG-ML VIAL	100 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 187.60	Generic · Prescription	EBEWE PHARMA	Valid
METHOTREXATE "EBEWE" 100MG-ML VIAL	100 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 1304.55	Generic · Prescription	EBEWE PHARMA	Valid
METHOTREXATE "EBEWE" 10MG-ML VIAL	10 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 29.35	Generic · Prescription	EBEWE PHARMA	Valid
METHOTREXATE 1G-10ML INJ.FOR I.V OR I.M	100 mg/ml	Solution for injection · Intravenous use	1 Vial	SAR 301.55	Generic · Prescription	HOSPIRA UK LIMITED	Valid
METHOTREXATE 2.5MG TAB.	2.5 mg	Tablet · Oral use	50 Blister	SAR 51.60	Generic · Prescription	EBEWE PHARMA	Valid
METOJECT 50 mg/ml solution for injection	50 mg/ml	Solution for injection in pre-filled syringe · Intravenous use	1 Pre-filled syringe	SAR 98.95	NCE · Prescription	medac Gesellschaft für klinische Spezialpräparate mbH	Valid
METOJECT 50 mg/ml solution for injection	50 mg/ml	Solution for injection in pre-filled syringe · Intravenous use	1 Pre-filled syringe	SAR 105.75	NCE · Prescription	medac Gesellschaft für klinische Spezialpräparate mbH	Valid
METOJECT 50 mg/ml solution for injection	50 mg/ml	Solution for injection in pre-filled syringe · Intravenous use	1 Pre-filled syringe	SAR 109.25	NCE · Prescription	medac Gesellschaft für klinische Spezialpräparate mbH	Valid
METOJECT 50 mg/ml solution for injection	50 mg/ml	Solution for injection in pre-filled syringe · Intravenous use	1 Pre-filled syringe	SAR 75.20	NCE · Prescription	medac Gesellschaft für klinische Spezialpräparate mbH	Valid
METOJECT 50 mg/ml solution for injection	50 mg/ml	Solution for injection in pre-filled syringe · Intravenous use	1 Pre-filled syringe	SAR 81.70	NCE · Prescription	medac Gesellschaft für klinische Spezialpräparate mbH	Valid
MEXAT 25 MG/ML SOLUTION FOR INJECTION	25 mg/ml	Solution for injection · Intramuscular and intravenous use	1 Vial	SAR 301.55	Generic · Prescription	Accord Healthcare Limited	Valid
MEXAT 25 MG/ML SOLUTION FOR INJECTION	25 mg/ml	Solution for injection · Intramuscular and intravenous use	1 Vial	SAR 187.60	Generic · Prescription	Accord Healthcare Limited	Valid
MEXAT 25 MG/ML SOLUTION FOR INJECTION	25 mg/ml	Solution for injection · Intramuscular and intravenous use	1 Vial	SAR 29.35	Generic · Prescription	Accord Healthcare Limited	Valid
Methotrexate BOS	2.5 mg	Tablet · Oral use	100 Bottle	SAR 107.50	Generic · Prescription	Boston Oncology Arabia	Valid
Methotrexate Venus	100 mg/ml	Solution for injection · Intramuscular and intravenous use	1 Vial	SAR 71.15	Generic · Prescription	VENUS REMEDIES LIMITED	Valid
Methotrexate Venus	25 mg/ml	Solution for injection · Intramuscular and intravenous use	1 Vial	SAR 20.70	Generic · Prescription	VENUS REMEDIES LIMITED	Valid
Metoject	50 mg/ml	Solution for injection in pre-filled syringe · Subcutaneous use	1 Pre-filled syringe	SAR 74.85	NCE · Prescription	medac Gesellschaft für klinische Spezialpräparate mbH	Valid
Metoject	50 mg/ml	Solution for injection in pre-filled syringe · Subcutaneous use	1 Pre-filled syringe	SAR 78.25	NCE · Prescription	medac Gesellschaft für klinische Spezialpräparate mbH	Valid
Mizotra	25 mg/ml	Solution for injection · Intramuscular and intravenous use	10 Vial	SAR 293.50	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Ruxaar	2.5 mg	Tablet · Oral use	100 Blister	SAR 107.50	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Trexan	10 mg	Tablet · Oral use	100 Bottle	SAR 275.40	Generic · Prescription	Exeltis Healthcare S.L	Valid
METHOTREXATE "EBEWE 10MG-ML AMP.	10 mg/ml	Solution for injection · Intravenous use	5 Ampoule	SAR 146.75	Generic · Prescription	EBEWE PHARMA	Withdrawn by MAH · Not Marketed
METHOTREXATE 2.5MG TAB	2.5 mg	Tablet · Oral use	100 Tablet Container	SAR 54.15	NCE · Prescription	WYETH	Withdrawn by MAH · Not Marketed

10 more — full table

Indications — CHI Daman Drug Formulary

ANKYLOSING SPONDYLITIS; BEHCET DISEASE; CROHN'S DISEASE; GRAFT VERSUS HOST DISEASE; GRANULOMATOSIS WITH POLYANGIITIS AND MICROSCOPIC POLYANGIITIS; JUVENILE IDIOPATHIC ARTHRITIS (JIA); LICHEN PLANUS; LYMPHOPLASMACYTIC LYMPHOMA; MYOSITIS; NON-INFECTIOUS UVEITIS; POMPE DISEASE (IOPD/LOPD); PSORIASIS; RHEUMATOID ARITHRITIS; SARCOIDOSIS; SYSTEMIC LUPUS ERYTHEMATOSUS; ULCERATIVE COLITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
METHOTREXATE SODIUM	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	injectable · injection	HOSPIRA	Prescription	10 Aug 1959
METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	injectable · injection	HOSPIRA	Prescription	10 Aug 1959
METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	injectable · injection	HIKMA PHARMS	Prescription	16 Sep 1986
METHOTREXATE SODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	injectable · injection	HIKMA PHARMS	Prescription	16 Sep 1986
METHOTREXATE SODIUM	EQ 200MG BASE/8ML (EQ 25MG BASE/ML)	injectable · injection	HIKMA PHARMS	Prescription	16 Sep 1986
METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	injectable · injection	HIKMA PHARMS	Prescription	16 Sep 1986
METHOTREXATE SODIUM	EQ 2.5MG BASE	tablet · oral	BARR	Prescription	15 Oct 1990
METHOTREXATE SODIUM	EQ 2.5MG BASE	tablet · oral	MYLAN	Prescription	15 May 1992
METHOTREXATE SODIUM	EQ 2.5MG BASE	tablet · oral	HIKMA PHARMS	Prescription	1 Aug 1994
METHOTREXATE SODIUM	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	injectable · injection	FRESENIUS KABI USA	Prescription	26 Feb 1999
METHOTREXATE PRESERVATIVE FREE	EQ 1GM BASE/VIAL	injectable · injection	FRESENIUS KABI USA	Prescription	26 Feb 1999
TREXALL	EQ 5MG BASE; EQ 7.5MG BASE; EQ 10MG BASE; EQ 15MG BASE	tablet · oral	BARR	Prescription	21 Mar 2001
METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/VIAL	injectable · injection	HIKMA PHARMS	Prescription	12 Aug 2005
METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	injectable · injection	ACCORD HLTHCARE	Prescription	30 Apr 2007
METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	injectable · injection	ACCORD HLTHCARE	Prescription	30 Apr 2007
METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	injectable · injection	ACCORD HLTHCARE	Prescription	30 Apr 2007
METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML)	injectable · injection		Prescription	8 Jan 2010
METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 250MG/10ML (EQ 25MG BASE/ML)	injectable · injection		Prescription	8 Jan 2010
METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 1GM BASE/40ML (EQ 25MG BASE/ML); EQ 50MG BASE/2ML (EQ 25MG BASE/ML); EQ 100MG BASE/4ML (EQ 25MG BASE/ML); EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	injectable · injection	PHARMACHEMIE BV	Prescription	8 Jan 2010
METHOTREXATE PRESERVATIVE FREE	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	injectable · injection		Prescription	27 Feb 2012
METHOTREXATE SODIUM PRESERVATIVE FREE	EQ 50MG BASE/2ML (EQ 25MG BASE/ML); EQ 100MG BASE/4ML (EQ 25MG BASE/ML); EQ 200MG BASE/8ML (EQ 25MG BASE/ML); EQ 250MG BASE/10ML (EQ 25MG BASE/ML)	injectable · injection	EUGIA PHARMA SPECLTS	Prescription	29 Mar 2012
RASUVO	7.5MG/0.15ML (7.5MG/0.15ML); 10MG/0.20ML (10MG/0.20ML); 12.5MG/0.25ML (12.5MG/0.25ML); 15MG/0.30ML (15MG/0.30ML); 17.5MG/0.35ML (17.5MG/0.35ML); 20MG/0.4ML (20MG/0.4ML); 22.5MG/0.45ML (22.5MG/0.45ML); 25MG/0.5ML (25MG/0.5ML); 30MG/0.6ML (30MG/0.6ML)	solution · subcutaneous	MEDEXUS	Prescription	10 Jul 2014
METHOTREXATE SODIUM	EQ 2.5MG BASE	tablet · oral	SUN PHARM	Prescription	21 May 2015
METHOTREXATE SODIUM	EQ 2.5MG BASE	tablet · oral	ZYDUS PHARMS	Prescription	13 Jan 2017
XATMEP	EQ 2.5MG BASE/ML	solution · oral	AZURITY	Prescription	25 Apr 2017

52 more — full table

EMA European Union — centrally authorised medicines

Nordimet Nordic Group B.V. · Authorised · authorised 18 Aug 2016 · ATC L04AX03

Therapeutic indication (EMA)

Nordimet is indicated for the treatment of: active rheumatoid arthritis in adult patients, polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate, moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients, induction of remission in moderate steroid-dependent Crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.

Jylamvo Oresund Pharma ApS · Authorised · authorised 29 Mar 2017 · ATC L04AX03

Therapeutic indication (EMA)

In rheumatological and dermatological diseases Active rheumatoid arthritis in adult patients. Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients. In oncology Maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACH-METHOTREXATE	02509067	2.5 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
APO-METHOTREXATE	02182963	2.5 MG	TABLET · ORAL	APOTEX INC
AURO-METHOTREXATE	02524023	2.5 MG	TABLET · ORAL	AURO PHARMA INC
JAMP METHOTREXATE TABLETS	02553740	10 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
M-METHOTREXATE	02534916	2.5 MG	TABLET · ORAL	MANTRA PHARMA INC
METHOFILL SELF-DOSE INJECTOR	02530775	10 MG / 0.2 ML	SOLUTION · SUBCUTANEOUS	ACCORD HEALTHCARE INC
METHOFILL SELF-DOSE INJECTOR	02530783	12.5 MG / 0.25 ML	SOLUTION · SUBCUTANEOUS	ACCORD HEALTHCARE INC
METHOFILL SELF-DOSE INJECTOR	02530791	15 MG / 0.3 ML	SOLUTION · SUBCUTANEOUS	ACCORD HEALTHCARE INC
METHOFILL SELF-DOSE INJECTOR	02530805	17.5 MG / 0.35 ML	SOLUTION · SUBCUTANEOUS	ACCORD HEALTHCARE INC
METHOFILL SELF-DOSE INJECTOR	02530813	20 MG / 0.4 ML	SOLUTION · SUBCUTANEOUS	ACCORD HEALTHCARE INC
METHOFILL SELF-DOSE INJECTOR	02530848	22.5 MG / 0.45 ML	SOLUTION · SUBCUTANEOUS	ACCORD HEALTHCARE INC
METHOFILL SELF-DOSE INJECTOR	02530856	25 MG / 0.5 ML	SOLUTION · SUBCUTANEOUS	ACCORD HEALTHCARE INC
METHOTREXATE INJECTION BP	02327236	25 MG / ML	SOLUTION · INTRA-ARTERIAL; INTRACEREBROVENTRICULAR; INTRATHECAL; INTRAVENOUS; INTRAMUSCULAR	ACCORD HEALTHCARE INC
METHOTREXATE INJECTION BP	02464365	25 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR; INTRA-ARTERIAL	ACCORD HEALTHCARE INC
METHOTREXATE INJECTION BP	02474735	25 MG / ML	SOLUTION · INTRAVENOUS	ACCORD HEALTHCARE INC
METHOTREXATE INJECTION BP	02474891	25 MG / ML	SOLUTION · INTRAVENOUS	ACCORD HEALTHCARE INC
METHOTREXATE INJECTION USP	02182777	25 MG / ML	SOLUTION · INTRA-ARTERIAL; INTRAVENOUS; INTRAMUSCULAR	PFIZER CANADA ULC
METHOTREXATE INJECTION USP	02182947	10 MG / ML	SOLUTION · INTRATHECAL; INTRAVENOUS; INTRA-ARTERIAL; INTRACEREBROVENTRICULAR; INTRAMUSCULAR	PFIZER CANADA ULC
METHOTREXATE INJECTION USP	02182955	25 MG / ML	SOLUTION · INTRATHECAL; INTRAMUSCULAR; INTRAVENOUS; INTRA-ARTERIAL; INTRACEREBROVENTRICULAR	PFIZER CANADA ULC
METHOTREXATE INJECTION USP	02182971	25 MG / ML	SOLUTION · INTRAVENOUS	PFIZER CANADA ULC
METHOTREXATE INJECTION, BP	02422166	7.5 MG / 0.3 ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS	PHARMASCIENCE INC
METHOTREXATE INJECTION, BP	02422174	10 MG / 0.4 ML	SOLUTION · INTRAMUSCULAR; INTRAVENOUS	PHARMASCIENCE INC
METHOTREXATE INJECTION, BP	02422182	15 MG / 0.6 ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	PHARMASCIENCE INC
METHOTREXATE INJECTION, BP	02422190	20 MG / 0.8 ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	PHARMASCIENCE INC
METHOTREXATE INJECTION, BP	02422204	25 MG / ML	SOLUTION · INTRAVENOUS; INTRAMUSCULAR	PHARMASCIENCE INC

25 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	METHOTREXATE 2.5 MG TABLET	$0.15774	per EA	23 Sep 2026
US NADAC	METHOTREXATE 250 MG/10 ML VIAL	$0.702	per ML	23 Sep 2026
US NADAC	METHOTREXATE 250 MG/10 ML VIAL	$3.1832	per ML	23 Sep 2026
US NADAC	METHOTREXATE 50 MG/2 ML VIAL	$1.80329	per ML	23 Sep 2026
US NADAC	METHOTREXATE 50 MG/2 ML VIAL	$1.23696	per ML	23 Sep 2026
US NADAC	METHOTREXATE 50 MG/2 ML VIAL	$3.1832	per ML	23 Sep 2026
US NADAC	RASUVO 10 MG/0.2 ML AUTOINJ	$721.8144	per ML	1 Apr 2026
US NADAC	RASUVO 12.5 MG/0.25 ML AUTOINJ	$574.86795	per ML	1 Apr 2026
US NADAC	RASUVO 15 MG/0.3 ML AUTOINJ	$480.00227	per ML	23 Sep 2026
US NADAC	RASUVO 17.5 MG/0.35 ML AUTOINJ	$409.92919	per ML	1 Apr 2026
US NADAC	RASUVO 20 MG/0.4 ML AUTOINJ	$362.2851	per ML	23 Sep 2026
US NADAC	RASUVO 25 MG/0.5 ML AUTOINJ	$289.365	per ML	23 Sep 2026
NHS Drug Tariff	Methotrexate 10mg tablets	£53.77	100 tablet	1 Oct 2026
NHS Drug Tariff	Methotrexate 10mg/0.2ml solution for injection pre-filled disposable devices	£13.26	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Methotrexate 10mg/0.2ml solution for injection pre-filled syringes	£11.25	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Methotrexate 10mg/0.4ml solution for injection pre-filled disposable devices	£13.77	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Methotrexate 10mg/0.4ml solution for injection pre-filled syringes	£13.77	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Methotrexate 12.5mg/0.25ml solution for injection pre-filled disposable devices	£14.35	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Methotrexate 12.5mg/0.25ml solution for injection pre-filled syringes	£12.34	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Methotrexate 12.5mg/0.5ml solution for injection pre-filled disposable devices	£14.85	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Methotrexate 12.5mg/0.5ml solution for injection pre-filled syringes	£14.85	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Methotrexate 15mg/0.3ml solution for injection pre-filled disposable devices	£14.41	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Methotrexate 15mg/0.3ml solution for injection pre-filled syringes	£12.40	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Methotrexate 15mg/0.6ml solution for injection pre-filled disposable devices	£14.92	1 pre-filled disposable injection	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.

WHO WHO Model List of Essential Medicines (2025)

8.2.1. Cytotoxic medicines · complementary
Lymphoid leukaemia, not elsewhere classified; Acute myeloid leukaemia with recurrent genetic abnormalities; Burkitt lymphoma including Burkitt leukaemia; Anaplastic large cell lymphoma, ALK-negative; Anaplastic large cell lymphoma, ALK-positive; Langerhans cell histiocytosis; Osteosarcoma of bone or articular cartilage of unspecified sites; Malignant neoplasms of breast; Malignant trophoblastic neoplasms of placenta
Parenteral > General injections > IV: 50 mg in vial (as sodium salt); 50 mg per 2 mL; 1000 mg per 10 mL concentrated injection | Oral > Solid: 2.5 mg (as sodium salt)
13.4. Dermatological medicines > Medicines affecting skin differentiation and proliferation · complementary
Psoriasis of unspecified type
Oral > Solid > tablet: 2.5 mg (as sodium salt); 10 mg (as sodium salt)
29.2. Disease-modifying anti-rheumatic drugs (DMARDs) · complementary
Rheumatoid arthritis, serology unspecified
Oral > Solid > tablet: 2.5 mg (as sodium salt)
29.3. Medicines for juvenile joint diseases · complementary
Juvenile idiopathic arthritis
Oral > Solid > tablet: 2.5 mg (as sodium salt)

Safety signals and safety-related labeling changes

US FDA 27 May 2026 METHOTREXATE SODIUM — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 27 May 2026 XATMEP — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 27 May 2026 JYLAMVO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 13 Mar 2026 METHOTREXATE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 28 May 2025 METHOTREXATE LPF — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 8 Feb 2024 PRAC signal: Hyperhomocysteinaemia
Action for MAH: update of the product information: No
US FDA 16 Nov 2023 METHOTREXATE PRESERVATIVE FREE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 16 Nov 2023 METHOTREXATE SODIUM PRESERVATIVE FREE — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 30 Aug 2023 Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactions
Photosensitivity reactions are known side effects of methotrexate treatment and can be severe. Patients should be advised to take precautions to protect their skin in the sun.
EMA PRAC 2 Sep 2021 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: Yes
EMA PRAC 6 May 2021 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No
EMA PRAC 26 Nov 2020 PRAC signal: Progressive multifocal leukoencephalopathy (PML)
Action for MAH: update of the product information: No
US FDA 11 Mar 2020 RASUVO — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 26 Dec 2019 OTREXUP — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 26 Dec 2019 OTREXUP PFS — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for methotrexate →

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.