Methotrexate Sodium

Methotrexate Sodium

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Questions & Answers

Side Effects & Adverse Reactions


Methotrexate formulations and diluents containing preservatives must not be used for intrathecal or high dose methotrexate therapy.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Neoplastic Diseases

Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole.

In acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents. Methotrexate is also indicated in the treatment of meningeal leukemia.

Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types. Methotrexate is also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-Hodgkin's lymphomas.

Methotrexate in high doses followed by leucovorin rescue in combination with other chemotherapeutic agents is effective in prolonging relapse-free survival in patients with non-metastatic osteosarcoma who have undergone surgical resection or amputation for the primary tumor.


Methotrexate is indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. It is important to ensure that a psoriasis "flare" is not due to an undiagnosed concomitant disease affecting immune responses.

Rheumatoid Arthritis including Polyarticular-Course Juvenile Rheumatoid Arthritis

Methotrexate is indicated in the management of selected adults with severe, active rheumatoid arthritis (ACR criteria), or children with active polyarticular-course juvenile rheumatoid arthritis, who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose nonsteroidal anti-inflammatory agents (NSAIDs).

Aspirin, (NSAIDs), and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylates has not been fully explored. (See PRECAUTIONS, Drug Interactions.) Steroids may be reduced gradually in patients who respond to methotrexate. Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine, or cytotoxic agents, has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued.


There is currently no drug history available for this drug.

Other Information

Methotrexate (formerly Amethopterin) is an antimetabolite used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis.

Chemically methotrexate is N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino] benzoyl]-L-glutamic acid. The structural formula is:


Molecular weight: 454.45                                                       C20H22N8O5

Methotrexate Injection, USP is sterile and non-pyrogenic and may be given by the intramuscular, intravenous, intra-arterial or intrathecal route. Only the preservative free formulation of Methotrexate Injection, USP may be administered by the intrathecal route.  (See DOSAGE AND ADMINISTRATION). 

Methotrexate Injection, USP, Isotonic Liquid, Preservative Free, for single use only, is available in 8 mL (200 mg) vials.

Each 25 mg/mL, 8 mL vial contains methotrexate sodium equivalent to 200 mg methotrexate and the following inactive ingredients: Sodium Chloride 0.490% w/v. Sodium Hydroxide and, if necessary, Hydrochloric Acid are added to adjust the pH to approximately 8.5. The 8 mL solution contains approximately 1.72 mEq of sodium per vial and is an isotonic solution.

Methotrexate Sodium Manufacturers

  • Mylan Institutional Llc
    Methotrexate Sodium Injection, Solution [Mylan Institutional Llc ]
  • Physicians Total Care, Inc.
    Methotrexate Sodium Tablet [Physicians Total Care, Inc.]
  • Remedyrepack Inc.
    Methotrexate Sodium Tablet [Remedyrepack Inc. ]
  • Bryant Ranch Prepack
    Methotrexate Sodium Tablet [Bryant Ranch Prepack]
  • Remedyrepack Inc.
    Methotrexate Sodium Tablet [Remedyrepack Inc. ]
  • Sandoz Inc
    Methotrexate Sodium Injection, Solution [Sandoz Inc]
  • Genpak Solutions Llc
    Methotrexate Sodium Tablet [Genpak Solutions Llc]
  • Pfizer Laboratories Div Pfizer Inc.
    Methotrexate Sodium Injection, Solution [Pfizer Laboratories Div Pfizer Inc.]
  • Roxane Laboratories, Inc
    Methotrexate Sodium Tablet [Roxane Laboratories, Inc]

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