Methotrexate
Active ingredient · 2 therapeutic classes
Sold as Jylamvo · Nordimet · METOJECT SUBCUTANEOUS · METHOFILL SELF-DOSE…
- Drug class
- Folic Acid Analogues
- Availability
- Prescription only
- Routes
- Oral, Subcutaneous, Intravenous, Intramuscular, Intrathecal
- Markets covered
- 4
- Products on record
- 182
- FDA reports (12 mo)
- 18,132
Overview
Plain-language summary, compiled from the cited regulatory records
Methotrexate is a folic acid analogue [1]. It is a dihydrofolate reductase inhibitor [1].
Methotrexate is approved for the treatment of certain cancers and autoimmune conditions [1]. It is indicated for adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen [1]. It is also used for adults with mycosis fungoides and for adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen [1]. Additionally, methotrexate is approved for the treatment of rheumatoid arthritis in adults [1].
In the past 12 months, there have been 18,132 adverse event reports for methotrexate [2]. The most frequently reported adverse events include off-label use, drug ineffectiveness, pain, condition aggravated, and arthralgia [2]. Methotrexate is available under several brand names [1].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 116 | May 29, 2026 |
| CA Canada | Health Canada | 59 | May 13, 2026 |
| US United States | FDA | 5 | May 7, 2026 |
| EU European Union | EMA | 2 | July 17, 2025 |
GBUnited Kingdom· MHRA
116 products
Uses
• Active rheumatoid arthritis in adult patients. • Severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients.
How to take
CACanada· Health Canada
59 products
Uses
Methotrexate Sodium Injection is indicated for Neoplastic diseases: • Choriocarcinoma: Methotrexate - as single chemotherapy or in combination with other drugs. • Intermediate, or high-grade Non-Hodgkin's Lymphoma as part of ProMACE-CytaBOM, ProMACE-MOPP, and Magrath protocols.
• Breast Cancer - as part of CMF (cyclophosphamide-methotrexate-fluorouracil) therapy. • Acute Lymphoblastic Leukemia (ALL) - as maintenance therapy. • Head and Neck Cancer - in combination with other chemotherapies. • Gastric Cancer - palliative combination chemotherapy.
• Metastasis of unknown primary - as palliative combination chemotherapy. • Osteogenic sarcoma (adjuvant) - high dose methotrexate with leucovorin rescue (HDMTX- LV) • Bladder Cancer (advanced) - as part of the M-VAC regimen. Methotrexate Sodium Injection is indicated as a Disease Modifying Antirheumatic Drug (DMARD) in the following diseases where standard therapeutic interventions fail: • Severe disabling psoriasis/psoriatic arthritis • Severe disabling rheumatoid arthritis (RA) • Severe disabling seronegative arthritides.
USUnited States· FDA
5 products
Uses
2 Rheumatoid Arthritis Methotrexate tablets are indicated for the treatment of adults with rheumatoid arthritis. 3 Polyarticular Juvenile Idiopathic Arthritis Methotrexate tablets are indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA).
4 Psoriasis Methotrexate tablets are indicated for the treatment of adults with severe psoriasis.
How to take
EUEuropean Union· EMA
2 products
Uses
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.
How to take
Drug interactions
Known interactions involving Methotrexate. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PLGB363900388 · revised October 31, 2025
- [2]Health Canada (DPD) · 02099705 · revised March 22, 2025
- [3]FDA DailyMed · 04a95db9-a124-4b… · revised June 4, 2024 [PDF]
- [4]European Medicines Agency · EMEA/H/C/003983 · revised July 17, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.