FDA label
What is methotrexate used for?
The FDA-approved uses of methotrexate, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for methotrexate (tablet) lists 4 uses: Neoplastic Diseases; Rheumatoid Arthritis; Polyarticular Juvenile Idiopathic Arthritis; Psoriasis.
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Methotrexate, tablet
Indications and Usage, quoted from the label by Teva Pharmaceuticals USA, Inc. (ANDA081099). Cross-references to other label sections are left out.
Neoplastic Diseases
Methotrexate tablets are indicated for the:
- treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen
- treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen
- treatment of adults with relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen
Rheumatoid Arthritis
Methotrexate tablets are indicated for the treatment of adults with rheumatoid arthritis.
Polyarticular Juvenile Idiopathic Arthritis
Methotrexate tablets are indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA).
Psoriasis
Methotrexate tablets are indicated for the treatment of adults with severe psoriasis.
Source: DailyMed label, set id 9b34b1d8-d125-41a2-9f6f-3fab67b573bd, version 17, effective June 4, 2026. NDC 0555-0572, one of 25 listings for this product.
Methotrexate, injection, solution
Indications and Usage, quoted from the label by Alembic Pharmaceuticals Limited (ANDA220225). Cross-references to other label sections are left out.
Acute Lymphoblastic Leukemia
Methotrexate Injection is indicated for the treatment of adult and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy regimen.
Meningeal Leukemia: Prophylaxis and Treatment
Methotrexate Injection is indicated for the prophylaxis and treatment of meningeal leukemia in adult and pediatric patients.
Non-Hodgkin Lymphoma
Methotrexate Injection is indicated for the treatment of adults and pediatric patients with non-Hodgkin lymphoma.
Osteosarcoma
Methotrexate Injection is indicated for the treatment of adults and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen.
Breast Cancer
Methotrexate Injection is indicated for the treatment of adults with breast cancer as part of a combination chemotherapy regimen.
Squamous Cell Carcinoma of the Head and Neck
Methotrexate Injection is indicated for the treatment of adults with squamous cell carcinoma of the head and neck as a single agent.
Gestational Trophoblastic Neoplasia
Methotrexate Injection is indicated for the treatment of adults with gestational trophoblastic neoplasia (GTN) as part of a combination chemotherapy regimen.
Rheumatoid Arthritis
Methotrexate Injection is indicated for the treatment of adults with rheumatoid arthritis (RA).
Polyarticular Juvenile Idiopathic Arthritis
Methotrexate Injection is indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA).
Psoriasis
Methotrexate Injection is indicated for the treatment of adults with severe psoriasis.
Source: DailyMed label, set id e98b2abd-8068-482e-9ce3-1ab262f0838e, version 1, effective April 16, 2026. NDC 46708-711, one of 12 listings for this product.
Questions
What is methotrexate used for?
The FDA label for methotrexate (tablet) lists 4 uses: Neoplastic Diseases; Rheumatoid Arthritis; Polyarticular Juvenile Idiopathic Arthritis; Psoriasis.
What drug class is methotrexate?
FDA lists methotrexate in the Folate Analog Metabolic Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Methotrexate
- Is Methotrexate a controlled substance?Federal schedule
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- Generic for RasuvoFDA Orange Book
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- Is Rasuvo a controlled substance?Federal schedule
- Folate Analog Metabolic Inhibitors listFDA drug class
- NDC 52652-2001Methotrexate NDC record
- NDC 54436-010Methotrexate NDC record
- NDC 54436-012Methotrexate NDC record