Last reviewed 2026-04-20 · How we verify

METHOTREXATE SODIUM

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS , SEVERE ADVERSE REACTIONS, and RISK OF MEDICATION ERRORS Methotrexate Tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Tablets are contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception [see Contraindications (4) , Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 )] . Methotrexate Tablets are contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [Contraindications ( 4 ), Warnings and Precautions ( 5.2 )] . Methotrexate tablets when inadvertently administered once daily have resulted in death ( 5.9 ). Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue Methotrexate Tablets as appropriate [Warnings and Precautions ( 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 )] . WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, SEVERE ADVERSE REACTIONS, and RISK OF MEDICATION ERRORS See full prescribing information for complete boxed warning. Methotrexate Tablets can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Tablets are contraindicated in pregnancy. For neoplastic diseases, advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 4 , 5.1 , 8.1 , 8.3 ) Methotrexate Tablets are contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis. ( 4 , 5.2 ) Methotrexate tablets when inadvertently administered once daily have resulted in death ( 5.9 ) Serious adverse reactions, including death, have been reported with methotrexate. Closely monitor for adverse reactions of the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys. Withhold or discontinue Methotrexate Tablets as appropriate. ( 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 )

Common side effects

• Elevated liver tests
• nausea/vomiting
• Stomatitis
• Thrombocytopenia (platelet count < 100,000/mm 3)
• Rash/pruritus/dermatitis
• Diarrhea
• Alopecia
• Leukopenia (white blood cell count < 3000/mm 3)
• Pancytopenia
• Dizziness
• Elevated liver tests
• Gastrointestinal reactions (e.g., nausea, vomiting, diarrhea)

Key clinical trials

• Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults (PHASE3)
• Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (PHASE2)
• Local Methotrexate Injections for the Treatment of Nail Psoriasis (PHASE4)
• Venetoclax Basket Trial for High Risk Hematologic Malignancies (PHASE1)
• A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML That Has Come Back or Does Not Respond to Therapy (PHASE1)
• Extended vs Short-term Abatacept Dosing for Graft Versus Host Disease Prophylaxis (PHASE2)
• A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia (PHASE2)
• Methotrexate Treatment of Arthritis Caused by Chikungunya Virus (MARCH) (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• METHOTREXATE SODIUM CI brief — competitive landscape report
• METHOTREXATE SODIUM updates RSS · CI watch RSS