METHOTREXATE SODIUM
Details
- Status
- Prescription
- First Approved
- 1953-12-07
- Routes
- INJECTION, ORAL, Injection, IRRIGATION
- Dosage Forms
- INJECTABLE, TABLET, Injectable, SOLUTION
Companies
METHOTREXATE SODIUM Approval History
What METHOTREXATE SODIUM Treats
25 FDA approvalsOriginally approved for its first indication in 1953 . Covers 25 distinct patient populations.
- Other (25)
Other
(25 approvals)- • Approved indication (Dec 1953) Priority
- • Approved indication (Aug 1959)
- • Approved indication (May 1986)
- • Approved indication (Jun 1986)
- • Approved indication (Sep 1986)
- • Approved indication (Apr 1988)
- • Approved indication (Jul 1988)
- • Approved indication (Oct 1988)
- • Approved indication (Oct 1990)
- • Approved indication (Nov 1991)
- • Approved indication (May 1992)
- • Approved indication (Aug 1994)
- • Approved indication (Feb 1999)Label Letter
- • Approved indication (Jun 1999)Letter
- • Approved indication (May 2015)
- • Approved indication (Jan 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Jan 2020)
- • Approved indication (Jan 2020)
- • Approved indication (May 2020)Label Letter
- • Approved indication (Mar 2021)Label Letter
- • Approved indication (Apr 2021)
- • Approved indication (Aug 2023)
- • Approved indication (May 2024)
- • Approved indication (Jun 2024)
METHOTREXATE SODIUM Boxed Warning
EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS • 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...
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS • 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 )]. • 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, and SEVERE ADVERSE REACTIONS 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 ) • 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 )
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
METHOTREXATE SODIUM FDA Label Details
ProIndications & Usage
FDA Label (PDF)Methotrexate Tablets are a diydrofolate reductase inhibitor 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 • Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen • Treatment of adults with rheumatoid arthritis • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) • Treatment of adults with severe psoriasis 1.1 Neoplastic Diseases Methotrexate...
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS • 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...
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.