Methotrexate
Tablet · Oral, Intramuscular, Intravenous
• Methotrexate Injection can cause embryo-fetal toxicity, including fetal death. For non-neoplastic diseases, Methotrexate Injection is contraindicated in pregnancy. Advise females and males of reproductive potential to use effective contraception [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3) ] .
• Methotrexate Injection is contraindicated in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis [see Contraindications (4) and Warnings and Precautions (5.2) ].
• Formulations with benzyl alcohol can cause severe central nervous toxicity or metabolic acidosis. Use only preservative-free Methotrexate Injection for treatment of neonates or low birth weight infants and…
Current shortage
Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3671-01) – Limited Availability (Teva Pharmaceuticals USA, Inc., updated Sep 15, 2026)
Estimated recovery: October 2026
Methotrexate Sodium, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-408-25) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Methotrexate Sodium, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-124-40) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3675-01) – Limited Availability (Teva Pharmaceuticals USA, Inc., updated Sep 15, 2026)
Estimated recovery: December 2026
Methotrexate Sodium, Injection, 25 mg/1 mL (NDC 63323-123-10) – Available (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Check wholesaler for inventory
Methotrexate, Preservative Free, Injection, 25 mg/1 mL (NDC 0143-9519-10) – Unavailable (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Additional lots will be available in the October 2026 timeframe. Product will be made available as it is released.
Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3678-01) – Limited Availability (Teva Pharmaceuticals USA, Inc., updated Sep 15, 2026)
Estimated recovery: October 2026
Methotrexate, Preservative Free, Injection, 1 g (NDC 0143-9830-01) – Unavailable (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Additional lots will be available in the September 2026 timeframe. Product will be made available as it is released.
Methotrexate Sodium, Injection, 50 mg/2 mL (25 mg/mL) (NDC 61703-350-38) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Methotrexate Preservative Free, Injection, 1 g (NDC 63323-122-50) – Available (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Check wholesaler for inventory
Uses
Methotrexate Injection is a folate analog metabolic inhibitor indicated for:
• The following neoplastic diseases for the: o Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen. ( 1.1 ) o Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia. ( 1.2 ) o Treatment of adult and pediatric patients with non-Hodgkin lymphoma. ( 1.3 ) o Treatment of adult and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. ( 1.4 ) o Treatment of adults with breast cancer as part of a combination chemotherapy regimen. ( 1.5 ) o Treatment of adults with squamous cell carcinoma of the head and neck as a single agent. ( 1.6 ) o Treatment of adults with gestational trophoblastic neoplasia as part of a combination chemotherapy regimen. ( 1.7 )
• Treatment of adults with rheumatoid arthritis (RA). ( 1.8 )
• Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA). ( 1.9 )
• Treatment of adults with severe psoriasis. ( 1.10 ) 1.1 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. 1.2 Meningeal Leukemia: Prophylaxis and Treatment Methotrexate Injection is indicated for the prophylaxis and treatment of meningeal leukemia in adult and pediatric patients. 1.3 Non-Hodgkin Lymphoma Methotrexate Injection is indicated for the treatment of adults and pediatric patients with non-Hodgkin lymphoma. 1.4 Osteosarcoma Methotrexate Injection is indicated for the treatment of adults and pediatric patients with osteosarcoma as part of a combination chemotherapy regimen. 1.5 Breast Cancer Methotrexate Injection is indicated for the treatment of adults with breast cancer as part of a combination chemotherapy regimen. 1.6 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. 1.7 Gestational Trophoblastic Neoplasia Methotrexate Injection is indicated for the treatment of adults with gestational trophoblastic neoplasia (GTN) as part of a combination chemotherapy regimen. 1.8 Rheumatoid Arthritis Methotrexate Injection is indicated for the treatment of adults with rheumatoid arthritis (RA). 1.9 Polyarticular Juvenile Idiopathic Arthritis Methotrexate Injection is indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA). 1.10 Psoriasis Methotrexate Injection is indicated for the treatment of adults with severe psoriasis.
Dosage and administration
• Verify pregnancy status in females of reproductive potential before starting Methotrexate Injection. ( 2.1 , 4 , 5.1 )
• Neoplastic diseases: Refer to the prescribing information for disease specific dosing recommendations. Follow guidelines for high-dose regimens. ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 , 2.9 )
• RA: Recommended starting dosage of 7.5 mg once weekly intramuscularly; adjust dose to achieve an optimal response. ( 2.10 )
• pJIA: Recommended starting dosage of 10 mg/m 2 once weekly subcutaneously or intramuscularly; adjust dose to achieve an optimal response. ( 2.11 )
• Psoriasis: Recommended dosage of 10 mg to 25 mg once weekly intramuscularly or intravenously; adjust dose to achieve optimal response. Once achieved, reduce to lowest possible dosage. ( 2.12 ) 2.1 Important Dosage and Safety Information
• Use only preservative-free Methotrexate Injection for treatment of neonates or low birth weight infants and for intrathecal use. Do not use benzyl alcohol-containing formulations for high-dose regimens unless immediate treatment is required and preservative-free formulations are not available [see Warnings and Precautions (5.3) and Use in Specific Populations (8.4) ].
• Verify pregnancy status in females of reproductive potential before starting Methotrexate Injection [see Contraindications (4) and Warnings and Precautions (5.1) ] .
• For patients switching between a methotrexate product administered orally and Methotrexate Injection, consider potential differences in bioavailability. 2.2 Recommended Monitoring and Concomitant Therapies for Intermediate- and High-Dose Regimens To decrease the risk of severe adverse reactions [see Warnings and Precautions (5) ] :
• Administer leucovorin rescue in patients receiving Methotrexate Injection doses of 500 mg/m 2 or greater (e.g., high-dose) .
• Consider leucovorin rescue for patients receiving Methotrexate Injection doses between 100 mg/m 2 to less than 500 mg/m 2 (e.g., intermediate-dose). Refer to the leucovorin prescribing information for additional information.
• For high-dose Methotrexate Injection regimens, follow the supportive care and monitoring instructions below. Also consider for patients receiving intermediate-dose Methotrexate Injection regimens. - Monitor serum creatinine, electrolytes, at baseline and at least daily during therapy - Administer intravenous fluids starting before the first dose and continuing throughout treatment to maintain adequate hydration and urine output - Alkalinize urine starting before the first dose and continuing throughout treatment to maintain a urinary pH of 7 or higher - Monitor methotrexate concentrations at least daily and adjust hydration and leucovorin dosing as needed
• Administer glucarpidase in patients who have toxic plasma methotrexate concentrations (>1 micromole per liter) and delayed methotrexate clearance due to impaired renal function (refer to the glucarpidase prescribing information for additional information). 2.3 Recommended Dosage for Acute Lymphoblastic Leukemia Methotrexate Injection is used as part of a multi-drug regimen. The recommended dosage varies from 10 to 5000 mg/m 2 intravenously. For high-dose Methotrexate Injection regimens, use leucovorin rescue in accordance with high-dose methotrexate regimen guidelines [see Dosage and Administration (2.2) ] . Lower doses (e.g., 20 to 30 mg/m 2 per week) may be used intramuscularly. Individualize the dose and schedule of Methotrexate Injection based on disease state, patient risk category, concurrent drugs used, phase of treatment, and response to treatment. 2.4 Recommended Dosage for Meningeal Leukemia: Prophylaxis and Treatment Use only preservative-free Methotrexate Injection for intrathecal use. Prior to administration, dilute preservative-free Methotrexate Injection to a concentration of 1 mg/mL in preservative-free 0.9% Sodium Chloride Injection, USP. The recommended intrathecal dose of Methotrexate Injection (preservative-free) is based on age:
• less than 1 year: 6 mg
• 1 to less than 2 years: 8 mg
• 2 to less than 3 years: 10 mg
• 3 to less than 9 years: 12 mg
• greater than or equal to 9 years: 12 to15 mg For treatment of meningeal leukemia, intrathecal methotrexate may be given at intervals of 2 or more days up to twice weekly; however, administration at intervals of less than 1 week may result in increased subacute toxicity. For meningeal leukemia prophylaxis, Methotrexate Injection is administered no more than once weekly. For patients with Down Syndrome, administer leucovorin rescue with intrathecal Methotrexate Injection. 2.5 Recommended Dosage for Non-Hodgkin Lymphoma The recommended dosage of Methotrexate Injection varies. When used in combination, recommended dosages range from 10 mg/m 2 to 8000 mg/m 2 intravenously. When used as a single agent, recommended dosages include 8000 mg/m 2 intravenously for central nervous system-directed therapy or 5 to 75 mg intravenously for cutaneous forms of non-Hodgkin lymphoma. As part of a combination chemotherapy regimen, a recommended dosage of Methotrexate Injection is 1000 mg/m 2 or 3000 mg/m 2 as an intravenous infusion over 24 hours followed by leucovorin rescue in accordance with high-dose methotrexate regimen guidelines [see Dosage and Administration (2.2) ] . For central nervous system-directed therapy, a recommended dosage of Methotrexate Injection is 8000 mg/m 2 as an intravenous infusion over 4 hours as a single agent or in combination with immunochemotherapy at doses ranging from 3000 mg/m 2 to 8000 mg/m 2 followed by leucovorin rescue in accordance with high-dose methotrexate regimen guidelines [see Dosage and Administration (2.2) ] . For intrathecal Methotrexate Injection (preservative-free), the recommended dose is based on age [see Dosage and Administration (2.4) ] . The frequency of administration varies based on whether it is being used for treatment or prophylaxis, and other factors.
Dosage forms and strengths
Injection: ( 3 )
• With preservative (multiple-dose vials): 50 mg/2 mL (25 mg/mL)
• Preservative-free (single-dose vials): 1 g/40 mL (25 mg/mL) Injection: Methotrexate Injection is a clear, yellow solution and is supplied in single-dose vials (preservative-free) and multiple-dose vials (with preservative) in the following strengths: With Preservative (Multiple-Dose Vial)
• 50 mg/2 mL (25 mg/mL) Preservative-Free (Single-Dose Vial)
• 1 g/40 mL (25 mg/mL)
Contraindications
Methotrexate Injection is contraindicated in:
• Patients with history of severe hypersensitivity to methotrexate [see Warnings and Precautions (5.2) ] .
• Pregnancy in patients with non-neoplastic diseases [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] .
• History of severe hypersensitivity to methotrexate. ( 4 )
• Pregnancy: in patients with non-neoplastic diseases. ( 4 )
Warnings and precautions
• Secondary malignancies can occur. ( 5.13 )
• Tumor lysis syndrome can occur in patients with rapidly growing tumors. ( 5.14 )
• Immunizations and Risks associated with Live Vaccines: Immunizations may be ineffective. Live vaccines are not recommended due to risk of disseminated infection. ( 5.15 )
• Infertility: Can cause impairment of fertility, oligospermia, and menstrual dysfunction. ( 5.16 , 8.3 ) 5.1 Embryo-Fetal Toxicity Based on published reports and its mechanism of action, methotrexate can cause embryo-fetal toxicity, including fetal death when administered to a pregnant woman. Methotrexate Injection is contraindicated for use in pregnant women with non-neoplastic diseases. Advise pregnant women with neoplastic diseases of the potential risk to a fetus. The preservative benzyl alcohol can cross the placenta; when possible, use the preservative-free formulation when Methotrexate Injection is needed during pregnancy to treat a neoplastic disease [see Warnings and Precautions (5.3) ] . Advise females of reproductive potential to use effective contraception during Methotrexate Injection treatment and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during Methotrexate Injection treatment and for 3 months after the last dose [see Contraindications (4) and Use in Specific Populations (8.1 , 8.3 , 8.4) ] . 5.2 Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, can occur with methotrexate [see Adverse Reactions (6.1) ]. If signs or symptoms of anaphylaxis or any other serious hypersensitivity reaction occurs, immediately discontinue Methotrexate Injection and institute appropriate therapy [see Contraindications (4) ] . 5.3 Risks of Serious Adverse Reactions due to Benzyl Alcohol-Preservative Formulations with benzyl alcohol can cause severe central nervous toxicity or metabolic acidosis, if used in neonates or low birth weight infants, intrathecally, or in high-dose regimens. Use only preservative-free Methotrexate Injection for treatment of neonates or low birth weight infants and for intrathecal use. Do not use benzyl alcohol-containing formulations for high-dose regimens unless immediate treatment is required, and preservative-free formulations are not available. The preservative benzyl alcohol can cross the placenta; when possible, use the preservative-free formulation when Methotrexate Injection is needed during pregnancy to treat a neoplastic disease [see Use in Specific Populations (8.1) ] . Serious and Fatal Adverse Reactions Including Gasping Syndrome in Neonates and Low Birth Weight Infants Serious and fatal adverse reactions including "gasping syndrome" can occur in neonates and low birth weight infants treated with drugs containing benzyl alcohol, including Methotrexate Injection with preservative. The "gasping syndrome" is characterized by central nervous system (CNS) depression, metabolic acidosis, and gasping respirations. When prescribing in infants (non-neonate, non-low birth weight), if a preservative-free formulation of Methotrexate Injection is not available and use of a benzyl alcohol-containing formulation is necessary, consider the combined daily metabolic load of benzyl alcohol from all sources including Methotrexate Injection (Methotrexate Injection contains 9.4 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Use in Specific Populations (8.4) ] . Neurotoxicity Due to Intrathecal Administration Serious neurotoxicity can occur following the intrathecal administration of Methotrexate Injection containing the preservative benzyl alcohol. Metabolic Acidosis with High-Dose Therapy Severe metabolic acidosis can occur with Methotrexate Injection that contains the preservative benzyl alcohol. 5.4 Myelosuppression Methotrexate suppresses hematopoiesis and can cause severe and life-threatening pancytopenia, anemia, aplastic anemia, leukopenia, neutropenia, and thrombocytopenia [see Adverse Reactions (6.1) ]. Obtain blood counts at baseline and periodically during treatment. Monitor patients for possible clinical complications of myelosuppression. Provide supportive care and withhold, reduce dose, or discontinue Methotrexate Injection as needed. 5.5 Serious Infections Patients treated with methotrexate are at increased risk for developing life-threatening or fatal bacterial, fungal, or viral infections including opportunistic infections such as Pneumocystis jiroveci pneumonia, invasive fungal infections, hepatitis B reactivation, tuberculosis primary infection or reactivation, and disseminated Herpes zoster and cytomegalovirus infections. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Methotrexate Injection. Withhold or discontinue Methotrexate Injection in patients who develop serious infections . 5.6 Renal Toxicity Methotrexate can cause renal toxicity including irreversible acute renal failure. Monitor renal function and withhold or discontinue Methotrexate Injection as needed for severe renal toxicity. For patients receiving high-dose regimens, follow recommendations to decrease the risk of renal injury and mitigate renal toxicity [see Dosage and Administration (2.2) ] . Patients with impaired renal function are at increased risk for methotrexate toxicity [see Use in Specific Populations (8.6) ] . Consider administration of glucarpidase in patients with toxic plasma methotrexate concentrations (>1 micromole per liter) and delayed clearance due to impaired renal function. [see Dosage and Administration (2.2) ] . 5.7 Hepatotoxicity Methotrexate can cause severe and potentially irreversible hepatotoxicity including fibrosis, cirrhosis, and fatal liver failure [see Adverse Reactions (6.1 , 6.2) ] .
Side effects
The following adverse reactions are described, or described in greater detail, in other sections:
• Hypersensitivity Reactions [see Warnings and Precautions (5.2) ]
• Myelosuppression [see Warnings and Precautions (5.4) ]
• Serious Infections [see Warnings and Precautions (5.5) ]
• Renal Toxicity [see Warnings and Precautions (5.6) ]
• Hepatotoxicity [see Warnings and Precautions (5.7) ]
• Neurotoxicity [see Warnings and Precautions (5.8) ]
• Gastrointestinal Toxicity [see Warnings and Precautions (5.9) ]
• Pulmonary Toxicity [see Warnings and Precautions (5.10) ]
• Dermatologic Reactions [see Warnings and Precautions (5.11) ]
• Secondary Malignancies [see Warnings and Precautions (5.13) ]
• Tumor Lysis Syndrome [see Warnings and Precautions (5.14) ]
• Increased Risk of Adverse Reactions due to Third-Space Accumulation [see Warnings and Precautions (5.17) ] Common adverse reactions include ulcerative stomatitis, leukopenia, nausea, and abdominal distress. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials and other studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Commonly reported adverse reactions include ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other frequently reported adverse reactions are infection, malaise, fatigue, chills, fever, and dizziness. Rheumatoid Arthritis The approximate incidences of methotrexate-attributed (i.e., placebo rate subtracted) adverse reactions in 12- to 18-week double-blind studies in patients (n = 128) with RA treated with low-dose oral (7.5 mg per week to 15 mg per week) pulse methotrexate are listed below. Most patients were on concomitant NSAIDs and some received corticosteroids. Hepatic histology was not examined in these short-term studies. Incidence ≥10%: Elevated liver function tests 15%, nausea/vomiting 10%. Incidence 3% to <10%: Stomatitis, thrombocytopenia (platelet count less than 100,000/mm 3 ). Incidence 1% to <3%: Rash/pruritus/dermatitis, diarrhea, alopecia, leukopenia (white blood cell count less than 3000/mm 3 ), pancytopenia, dizziness. Two other controlled trials of patients (n = 680) with RA on 7.5 mg per week to 15 mg per week oral doses showed the following adverse reactions: Incidence 1%: Interstitial pneumonitis. Other less common adverse reactions: Decreased hematocrit, headache, upper respiratory infection, anorexia, arthralgias, chest pain, coughing, dysuria, eye discomfort, epistaxis, fever, infection, sweating, tinnitus, vaginal discharge. Polyarticular Juvenile Idiopathic Arthritis (pJIA) The approximate incidences of adverse reactions reported in patients 2 to 18 years of age with pJIA treated with oral, weekly doses of methotrexate (5 mg/m 2 per week to 20 mg/m 2 per week or 0.1 mg/kg per week to 0.65 mg/kg per week) were as follows (most patients were receiving concomitant NSAIDs, and some received corticosteroids): elevated liver function tests, 14%; gastrointestinal reactions (e.g., nausea, vomiting, diarrhea), 11%; stomatitis, 2%; leukopenia, 2%; headache, 1.2%; alopecia, 0.5%; dizziness, 0.2%; rash, 0.2%. Psoriasis In two published series of adult psoriasis patients (n = 204, 248) treated with methotrexate doses up to 25 mg per week for up to 4 years, adverse reaction rates were similar to those in patients with RA, except for alopecia, photosensitivity, and "burning of skin lesions" (each 3% to 10%). Painful plaque erosions have been reported. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of methotrexate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders: Aplastic anemia, lymphadenopathy, hypogammaglobulinemia Cardiovascular disorders: Thromboembolic events (including arterial thrombosis, cerebral thrombosis, deep vein thrombosis, retinal vein thrombosis, thrombophlebitis, and pulmonary embolus), pericarditis, pericardial effusion, hypotension, sudden death Endocrine: Diabetes Eye disorders: Optic neuropathy, blurred vision, ocular irritation, conjunctivitis, xerophthalmia Gastrointestinal disorders: Hemorrhagic enteritis, intestinal perforation, gingivitis, pancreatitis, pharyngitis, hematemesis, melena, gastrointestinal ulceration and bleeding Hepatobiliary disorders: Acute hepatitis, decreased serum albumin, fibrosis, cirrhosis, liver failure Immune system disorders: Anaphylaxis, anaphylactoid reactions, vasculitis Metabolism: Hyperglycemia Musculoskeletal disorders: Stress fracture, soft tissue necrosis, arthralgia, myalgia, osteoporosis Nervous system disorders: Headaches, drowsiness, blurred vision, speech impairment (including dysarthria and aphasia), transient cognitive dysfunction, mood alteration, unusual cranial sensations, paresis, encephalopathy, leukoencephalopathy, and convulsions.
Drug interactions
Refer to full prescribing information for drug interactions with Methotrexate Injection. ( 7 ) 7.1 Effects of Other Drugs on Methotrexate Drugs that Increase Methotrexate Exposure Coadministration of methotrexate with the following products may increase methotrexate plasma concentrations, which may increase the risk of methotrexate severe adverse reactions. Increased organ specific adverse reactions may also occur when methotrexate is coadministered with hepatotoxic or nephrotoxic products. If coadministration cannot be avoided, monitor closely for methotrexate adverse reactions when coadministered with:
• Penicillin or sulfonamide antibiotics
• Highly protein bound drugs (e.g., oral anticoagulants, phenytoin, salicylates, sulfonamides, sulfonylureas, and tetracyclines)
• Proton pump inhibitors
• Probenecid
• Antifolate drugs (e.g., dapsone, pemetrexed, pyrimethamine and sulfonamides)
• Aspirin and other nonsteroidal anti-inflammatory drugs Unexpectedly severe and fatal gastrointestinal toxicity can occur with concomitant administration of methotrexate (primarily at high-dose) and nonsteroidal anti-inflammatory drugs (NSAIDs).
• Mercaptopurine
• Hepatotoxic products
• Weak acids (e.g., salicylates)
• Nephrotoxic products
• Hematotoxic agents Nitrous Oxide Coadministration of methotrexate with nitrous oxide anesthesia potentiates the effect of methotrexate on folate-dependent metabolic pathways, which may increase the risk of severe methotrexate adverse reactions. Avoid nitrous oxide anesthesia in patients receiving methotrexate. Consider alternative therapies in patients who have received prior nitrous oxide anesthesia. Folic Acid Coadministration of methotrexate with folic acid or its derivatives decreases the clinical effectiveness of methotrexate in patients with neoplastic diseases. Methotrexate competes with reduced folates for active transport across cell membranes. Instruct patients to take folic or folinic acid only as directed by their healthcare provider [see Warnings and Precautions (5.12) ]. 7.2 Effects of Methotrexate on Other Drugs Theophylline Coadministration of methotrexate with theophylline increases theophylline plasma concentrations which may increase the risk of theophylline adverse reactions. Monitor theophylline levels and adjust the theophylline dosage in accordance with approved product labeling.
Use in specific populations
• Lactation: Advise not to breastfeed. ( 8.2 )
• Pediatric use: Intermediate-dose methotrexate can cause serious neurotoxicity in patients with acute lymphoblastic leukemia. ( 8.4 ) 8.1 Pregnancy Risk Summary Methotrexate Injection is contraindicated in pregnant women with non-neoplastic diseases. Based on published reports and its mechanism of action, methotrexate can cause embryo-fetal toxicity and fetal death when administered to a pregnant woman [see Data and Clinical Pharmacology (12.1) ]. There are no animal data that meet current standards for nonclinical developmental toxicity studies. Advise pregnant women with neoplastic diseases of the potential risk to a fetus. The preservative benzyl alcohol can cross the placenta; when possible, use the preservative-free formulation when Methotrexate Injection is needed during pregnancy to treat a neoplastic disease [see Warnings and Precautions (5.3) and Use in Specific Populations (8.4) ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Human Data Published data from case reports, literature reviews, and observational studies report that methotrexate exposure during pregnancy is associated with an increased risk of embryo-fetal toxicity and fetal death. Methotrexate exposure during the first trimester of pregnancy is associated with an increased incidence of spontaneous abortions and multiple adverse developmental outcomes, including skull anomalies, facial dysmorphism, CNS abnormalities, limb abnormalities, and sometimes cardiac anomalies and intellectual impairment. Adverse outcomes associated with exposure during second and third trimesters of pregnancy include intrauterine growth restriction and functional abnormalities. Because methotrexate is widely distributed and persists in the body for a prolonged period, there is a potential risk to the fetus from preconception methotrexate exposure. A prospective multicenter study evaluated pregnancy outcomes in women taking methotrexate less than or equal to 30 mg per week after conception. The rate of spontaneous abortion/miscarriage in pregnant women exposed to methotrexate was 42.5% (95% confidence interval [95% CI] 29.2–58.7), which was higher than in unexposed patients with autoimmune disease (22.5%, 95% CI 16.8–29.7) and unexposed patients with non-autoimmune disease (17.3%, 95% CI 13–22.8). Of the live births, the rate of major birth defects in pregnant women exposed to methotrexate after conception was higher than in unexposed patients with autoimmune disease (adjusted odds ratio (OR) 1.8 [95% CI 0.6–5.7]) and unexposed patients with non-autoimmune disease (adjusted OR 3.1 [95% CI 1.03–9.5]) (2.9%). Major birth defects associated with pregnancies exposed to methotrexate after conception were not always consistent with methotrexate-associated adverse developmental outcomes. 8.2 Lactation Risk Summary Limited published literature reports the presence of methotrexate in human milk in low amounts, with the highest breast milk to plasma concentration ration reported to be 0.08:1. No information is available on the effects of methotrexate on a breastfed infant or on milk production. Because of the potential for serious adverse reactions from methotrexate in breastfed infants, advise women not to breastfeed during treatment with Methotrexate Injection and for 1 week after the last dose. 8.3 Females and Males of Reproductive Potential Methotrexate can cause malformations and fetal death at doses less than or equal to the recommended clinical doses [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating Methotrexate Injection [see Contraindications (4) and Use in Specific Populations (8.1) ]. Contraception Females Advise females of reproductive potential to use effective contraception during and for 6 months after the last dose of Methotrexate Injection therapy. Males Methotrexate can cause chromosomal damage to sperm cells. Advise males with female partners of reproductive potential to use effective contraception during and for 3 months after the last dose of Methotrexate Injection therapy. Infertility Females Based on published reports of female infertility after therapy with methotrexate, advise females of reproductive potential that Methotrexate Injection can cause impairment of fertility and menstrual dysfunction during and after cessation of therapy. It is not known if the infertility may be reversed in all affected females. Males Based on published reports of male infertility after therapy with methotrexate, advise males that Methotrexate Injection can cause oligospermia or infertility during and after cessation of therapy. It is not known if the infertility may be reversed in all affected males. 8.4 Pediatric Use The safety and effectiveness of Methotrexate Injection in pediatric patients have been established for ALL, meningeal leukemia prophylaxis and treatment, non-Hodgkin lymphoma, osteosarcoma and in pJIA. Clinical studies evaluating the use of methotrexate in pediatric patients with pJIA demonstrated safety comparable to that observed in adults with RA [see Adverse Reactions (6.1) ]. The safety and effectiveness of Methotrexate Injection have not been established in pediatric patients for the treatment of breast cancer, squamous cell carcinoma of the head and neck, gestational trophoblastic neoplasia, rheumatoid arthritis, and psoriasis. Additional risk information is described below. Risks of Serious Adverse Reactions due to Benzyl Alcohol-Preservative Due to the risk of serious adverse reactions and fatal gasping syndrome following administration of intravenous solutions containing the preservative benzyl alcohol in neonates, use only preservative-free Methotrexate Injection in neonates and low birth weight infants.
Pregnancy
8.1 Pregnancy Risk Summary Methotrexate Injection is contraindicated in pregnant women with non-neoplastic diseases. Based on published reports and its mechanism of action, methotrexate can cause embryo-fetal toxicity and fetal death when administered to a pregnant woman [see Data and Clinical Pharmacology (12.1) ]. There are no animal data that meet current standards for nonclinical developmental toxicity studies. Advise pregnant women with neoplastic diseases of the potential risk to a fetus. The preservative benzyl alcohol can cross the placenta; when possible, use the preservative-free formulation when Methotrexate Injection is needed during pregnancy to treat a neoplastic disease [see Warnings and Precautions (5.3) and Use in Specific Populations (8.4) ] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Human Data Published data from case reports, literature reviews, and observational studies report that methotrexate exposure during pregnancy is associated with an increased risk of embryo-fetal toxicity and fetal death. Methotrexate exposure during the first trimester of pregnancy is associated with an increased incidence of spontaneous abortions and multiple adverse developmental outcomes, including skull anomalies, facial dysmorphism, CNS abnormalities, limb abnormalities, and sometimes cardiac anomalies and intellectual impairment. Adverse outcomes associated with exposure during second and third trimesters of pregnancy include intrauterine growth restriction and functional abnormalities. Because methotrexate is widely distributed and persists in the body for a prolonged period, there is a potential risk to the fetus from preconception methotrexate exposure. A prospective multicenter study evaluated pregnancy outcomes in women taking methotrexate less than or equal to 30 mg per week after conception. The rate of spontaneous abortion/miscarriage in pregnant women exposed to methotrexate was 42.5% (95% confidence interval [95% CI] 29.2–58.7), which was higher than in unexposed patients with autoimmune disease (22.5%, 95% CI 16.8–29.7) and unexposed patients with non-autoimmune disease (17.3%, 95% CI 13–22.8). Of the live births, the rate of major birth defects in pregnant women exposed to methotrexate after conception was higher than in unexposed patients with autoimmune disease (adjusted odds ratio (OR) 1.8 [95% CI 0.6–5.7]) and unexposed patients with non-autoimmune disease (adjusted OR 3.1 [95% CI 1.03–9.5]) (2.9%). Major birth defects associated with pregnancies exposed to methotrexate after conception were not always consistent with methotrexate-associated adverse developmental outcomes.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of Methotrexate Injection in pediatric patients have been established for ALL, meningeal leukemia prophylaxis and treatment, non-Hodgkin lymphoma, osteosarcoma and in pJIA. Clinical studies evaluating the use of methotrexate in pediatric patients with pJIA demonstrated safety comparable to that observed in adults with RA [see Adverse Reactions (6.1) ]. The safety and effectiveness of Methotrexate Injection have not been established in pediatric patients for the treatment of breast cancer, squamous cell carcinoma of the head and neck, gestational trophoblastic neoplasia, rheumatoid arthritis, and psoriasis. Additional risk information is described below. Risks of Serious Adverse Reactions due to Benzyl Alcohol-Preservative Due to the risk of serious adverse reactions and fatal gasping syndrome following administration of intravenous solutions containing the preservative benzyl alcohol in neonates, use only preservative-free Methotrexate Injection in neonates and low birth weight infants. The "gasping syndrome" is characterized by CNS depression, metabolic acidosis, and gasping respirations. Serious adverse reactions including fatal reactions and the "gasping syndrome" occurred in premature neonates and low birth weight infants in the neonatal intensive care unit who received drugs containing benzyl alcohol as a preservative. In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). Additional adverse reactions include gradual neurological deterioration, seizures, intracranial hemorrhage, hematological abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Preterm, low birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. When prescribing in infants (non-neonate, non-low birth weight), if a preservative-free formulation of Methotrexate Injection is not available and use of a benzyl alcohol-containing formulation is necessary, consider the combined daily metabolic load of benzyl alcohol from all sources including Methotrexate Injection (Methotrexate Injection contains 9.4 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known . Do not administer methotrexate formulations containing benzyl alcohol intrathecally due to the risk of severe neurotoxicity [see Warnings and Precautions (5.3) ]. Leukemia/Lymphoma Serious neurotoxicity, frequently manifested as generalized or focal seizures, has been reported with unexpectedly increased frequency among pediatric patients with acute lymphoblastic leukemia who were treated with intermediate-dose intravenous methotrexate (1 g/m 2 ) [see Warnings and Precautions (5.8) ].
Geriatric use
8.5 Geriatric Use Clinical studies of methotrexate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Overdosage
Manifestations Overdosage, including fatal overdosage, has occurred with methotrexate [see Warnings and Precautions (5.19) ]. Manifestations of overdosage include adverse reactions reported at pharmacologic doses, particularly hematologic and gastrointestinal reactions (e.g., leukopenia, thrombocytopenia, anemia, pancytopenia, myelosuppression, mucositis, stomatitis, oral ulceration, nausea, vomiting, gastrointestinal ulceration, or gastrointestinal bleeding). In some cases, no symptoms were reported; however, sepsis or septic shock, renal failure, and aplastic anemia were also reported. Manifestations of intrathecal overdosage include CNS symptoms (e.g., headache, nausea and vomiting, seizure or convulsion, and acute toxic encephalopathy). In some cases, no symptoms were reported; however, cerebellar herniation associated with increased intracranial pressure and acute toxic encephalopathy have also been reported. Management Leucovorin and levoleucovorin are indicated to diminish the toxicity and counteract the effect of inadvertently administered overdosages of methotrexate. Administer leucovorin or levoleucovorin as soon as possible after overdosage (refer to the leucovorin or levoleucovorin prescribing information). Monitor serum methotrexate concentrations closely to guide leucovorin or levoleucovorin therapy. Monitor serum creatinine concentrations closely because high serum methotrexate concentrations may cause renal damage leading to acute renal failure. Glucarpidase is indicated for the treatment of toxic methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function (refer to the glucarpidase prescribing information). If glucarpidase is used, do not administer leucovorin within 2 hours before or after a dose of glucarpidase because leucovorin is a substrate for glucarpidase. Hydration and urinary alkalinization may be necessary to prevent the precipitation of methotrexate and/or its metabolites in the renal tubules. Neither hemodialysis nor peritoneal dialysis has been shown to improve methotrexate elimination. However, effective clearance of methotrexate has been reported with acute, intermittent hemodialysis using a high-flux dialyzer.
Description
Methotrexate is a folate analog metabolic inhibitor with the chemical name of N -[4-[[(2,4-diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L-glutamic acid and a molecular weight of 454.44. The molecular formula is C 20 H 22 N 8 O 5 , and the structural formula is shown below: Methotrexate Injection with preservative is supplied in sterile multiple-dose vials for intravenous, intramuscular, or subcutaneous use.
• Each 25 mg/mL, 2 mL vial contains 50 mg methotrexate equivalent to 54.8 mg of methotrexate sodium, 18.8 mg of benzyl alcohol as a preservative and Sodium chloride 5.2 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust the pH to 8.5. Preservative-free Methotrexate Injection is supplied in sterile single-dose vials for intravenous, intramuscular, subcutaneous, or intrathecal use.
• Each 25 mg/mL, 40 mL vial contains 1000 mg methotrexate equivalent to 1096.7 mg of methotrexate sodium, and the following inactive ingredients: Sodium chloride 196 mg. May contain sodium hydroxide and/or hydrochloric acid to adjust pH to 8.5. Chemical Structure
Mechanism of action
12.1 Mechanism of Action Methotrexate inhibits dihydrofolic acid reductase. Dihydrofolates must be reduced to tetrahydrofolates by this enzyme before they can be utilized as carriers of one-carbon groups in the synthesis of purine nucleotides and thymidylate. Therefore, methotrexate interferes with DNA synthesis, repair, and cellular replication. Actively proliferating tissues such as malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder are in general more sensitive to this effect of methotrexate. The mechanism of action in rheumatoid arthritis, pJIA, and in psoriasis is unknown.
How supplied
How Supplied Methotrexate Injection is a clear, yellow, sterile solution available with preservative (multiple-dose vials) and preservative-free (single-dose vials) as follows: Strength/Fill volume NDC number Pack style With Preservative 50 mg/2 mL (25 mg/mL) 61703-350-10 Carton containing five (5) multiple-dose vials Preservative-free 1 g/40 mL (25 mg/mL) 61703-408-25 Carton containing one (1) single-dose vial Carton contents NDC Methotrexate Injection, With Preservative, 5 multiple-dose vials 50 mg/2 mL (25 mg/mL) 61703-350-10 Preservative-free Methotrexate Injection, 1 single-dose vial 1 g/40 mL (25 mg/mL) 61703-408-25 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. After first puncture, store multiple-dose vials at 2°C to 8°C, and use within 30 days. Methotrexate Injection is a hazardous drug. Follow applicable special handling and disposal procedures. 1
Storage
Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. After first puncture, store multiple-dose vials at 2°C to 8°C, and use within 30 days. Methotrexate Injection is a hazardous drug. Follow applicable special handling and disposal procedures. 1
Patient information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Embryo-Fetal Toxicity
• Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1) ].
• Advise females of reproductive potential to use effective contraception during Methotrexate Injection therapy and for 6 months after the last dose [see Use in Specific Populations (8.3) ].
• Advise males of reproductive potential to use effective contraception during Methotrexate Injection therapy and for 3 months after the last dose [see Use in Specific Populations (8.3) ]. Hypersensitivity Reactions Advise patients of the potential risk of hypersensitivity and that Methotrexate Injection is contraindicated in patients with a history of severe hypersensitivity to methotrexate. Advise patients to seek immediate medical attention if signs or symptoms of a hypersensitivity reaction occur [see Warnings and Precautions (5.2) ]. Myelosuppression and Serious Infections Advise patient to contact their healthcare provider immediately for new onset fever, symptoms of infection, easy bruising or persistent bleeding [see Warnings and Precautions (5.4 , 5.5) ]. Renal Toxicity Advise patients that methotrexate can cause renal toxicity. Advise patients to immediately contact their healthcare provider for signs or symptoms of renal toxicity, such as marked increases or decreases in urinary output [see Warnings and Precautions (5.6) ]. Hepatotoxicity Advise patients to report signs or symptoms of hepatic toxicity and avoidance of alcohol during methotrexate treatment [see Warnings and Precautions (5.7) ]. Neurotoxicity Advise patient to contact their healthcare provider immediately if they develop new neurological symptoms [see Warnings and Precautions (5.8) ]. Gastrointestinal Toxicity Advise patients to contact their healthcare provider if they develop diarrhea, vomiting, or stomatitis. Advise patients to immediately contact their healthcare provider for high fever, rigors, persistent or severe abdominal pain, severe constipation, hematemesis, or melena [see Warnings and Precautions (5.9) ]. Pulmonary Toxicity Advise patients to contact their healthcare provider for symptoms of cough, fever, and dyspnea [see Warnings and Precautions (5.10) ]. Dermatologic Toxicity Advise patients that Methotrexate Injection can cause serious skin rash and to immediately contact their healthcare provider for new or worsening skin rash. Advise patients to avoid excessive sun exposure and to use sun protection measures [see Warnings and Precautions (5.11) ]. Secondary Malignancies Advise patients on the risk of second primary malignancies during treatment with Methotrexate Injection [see Warnings and Precautions (5.13) ]. Lactation Advise women not to breastfeed during treatment with Methotrexate Injection and for 1 week after the last dose [see Use in Specific Populations (8.2) ]. Infertility Advise females and males of reproductive potential that Methotrexate Injection may cause impairment of fertility [see Use in Specific Populations (8.3) ] . Drug Interactions
• Advise patients and caregivers to inform their healthcare provider of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions (7) ] .
• Instruct patients being treated for neoplastic indication to not take products containing folic acid or folinic acid unless directed to do so by their healthcare provider [see Warnings and Precautions (5.12) ].
Label text from the FDA structured product label by Hospira, Inc. (revised Aug 22, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Methotrexate Sodium in 40 products
- Methotrexate in 11 products
Methotrexate NDC products (51)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-5457 | Methotrexate Sodium 2.5 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 16729-486 | Methotrexate Sodium 2.5 mg/1 Tablet | Accord Healthcare Inc. | ANDA |
| 16729-277 | Methotrexate 25 mg/mL Injection | Accord Healthcare, Inc. | ANDA |
| 62332-711 | Methotrexate Sodium 25 mg/mL Injection, Solution | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-730 | Methotrexate Sodium 2.5 mg/1 Tablet | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-712 | Methotrexate Sodium 25 mg/mL Injection, Solution | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-730 | Methotrexate Sodium 2.5 mg/1 Tablet | Alembic Pharmaceuticals Limited | ANDA |
| 46708-712 | Methotrexate Sodium 25 mg/mL Injection, Solution | Alembic Pharmaceuticals Limited | ANDA |
| 46708-711 | Methotrexate Sodium 25 mg/mL Injection, Solution | Alembic Pharmaceuticals Limited | ANDA |
| 59651-182 | Methotrexate Sodium 2.5 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 42291-594 | Methotrexate Sodium 2.5 mg/1 Tablet | AvKARE | ANDA |
| 50268-554 | Methotrexate 2.5 mg/1 Tablet | AvPAK | ANDA |
| 72162-2647 | Methotrexate Sodium 2.5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-0782 | Methotrexate Sodium 2.5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1118 | Methotrexate Sodium 2.5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1772 | Methotrexate Sodium 2.5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2221 | Methotrexate Sodium 2.5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-2174 | Methotrexate Sodium 2.5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 62135-772 | Methotrexate Sodium 2.5 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 67046-1524 | Methotrexate Sodium 2.5 mg/1 Tablet | Coupler LLC | ANDA |
| 55150-510 | Methotrexate Sodium 50 mg/2mL Injection, Solution | Eugia US LLC | ANDA |
| 55150-511 | Methotrexate Sodium 100 mg/4mL Injection, Solution | Eugia US LLC | ANDA |
| 55150-512 | Methotrexate Sodium 200 mg/8mL Injection, Solution | Eugia US LLC | ANDA |
| 55150-513 | Methotrexate Sodium 250 mg/10mL Injection, Solution | Eugia US LLC | ANDA |
| 63323-122 | Methotrexate Sodium 1 g/1 Injection, Powder, Lyophilized, For Solution | Fresenius Kabi USA, LLC | ANDA |
| 63323-123 | Methotrexate Sodium 25 mg/mL Injection, Solution | Fresenius Kabi USA, LLC | ANDA |
| 51407-121 | Methotrexate Sodium 2.5 mg/1 Tablet | Golden State Medical Supply, Inc. | ANDA |
| 0143-9516 | Methotrexate 25 mg/mL Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9367 | Methotrexate 1 g/1 Injection, Powder, Lyophilized, For Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9517 | Methotrexate 25 mg/mL Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9518 | Methotrexate 25 mg/mL Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9830 | Methotrexate 1 g/1 Injection, Powder, Lyophilized, For Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9519 | Methotrexate 25 mg/mL Solution | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0904-7141 | Methotrexate 2.5 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 51079-670 | Methotrexate Sodium 2.5 mg/1 Tablet | Mylan Institutional Inc. | ANDA |
| 0378-0014 | Methotrexate Sodium 2.5 mg/1 Tablet | Mylan Pharmaceuticals Inc. | ANDA |
| 68071-3991 | Methotrexate Sodium 2.5 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3765 | Methotrexate Sodium 2.5 mg/1 Tablet | NuCare Pharmaceuticals, Inc. | ANDA |
| 82804-136 | Methotrexate Sodium 2.5 mg/1 Tablet | Proficient Rx LP | ANDA |
| 48433-065 | Methotrexate Sodium 2.5 mg/1 Tablet | Safecor Health LLC | ANDA |
| 47335-235 | Methotrexate Sodium 2.5 mg/1 Tablet | Sun Pharmaceutical Industries, Inc. | ANDA |
| 0703-3671 | Methotrexate Sodium 25 mg/mL Injection, Solution | Teva Parenteral Medicines, Inc. | ANDA |
| 0703-3675 | Methotrexate Sodium 25 mg/mL Injection, Solution | Teva Parenteral Medicines, Inc. | ANDA |
| 0703-3678 | Methotrexate Sodium 25 mg/mL Injection, Solution | Teva Parenteral Medicines, Inc. | ANDA |
| 0555-0572 | Methotrexate Sodium 2.5 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA |
| 70771-1058 | Methotrexate 2.5 mg/1 Tablet | Zydus Lifesciences Limited | ANDA |
| 68382-775 | Methotrexate 2.5 mg/1 Tablet | Zydus Pharmaceuticals USA Inc. | ANDA |
| 61703-408 | Methotrexate Sodium 25 mg/mL Injection, Solution | Hospira, Inc. | NDA |
| 61703-350 | Methotrexate Sodium 25 mg/mL Injection, Solution | Hospira, Inc. | NDA |
| 61703-161 | Methotrexate Sodium 25 mg/mL Injection, Solution | Hospira, Inc. | NDA |
| 61703-124 | Methotrexate Sodium 25 mg/mL Injection, Solution | Hospira, Inc. | NDA |
Methotrexate recalls
- D-0553-2021 Jun 2, 2021 · Class II · Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage. - D-1681-2012 Sep 26, 2012 · Class II · Terminated
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial.…
Frequently asked questions
What is Methotrexate used for?
Methotrexate Injection is a folate analog metabolic inhibitor indicated for: • The following neoplastic diseases for the: o Treatment of adult and pediatric patients with acute lymphoblastic leukemia as part of a combination chemotherapy regimen. ( 1.1 ) o Prophylaxis and treatment of adult and pediatric patients with meningeal leukemia. ( 1.2 ) o Treatment of adult and pediatric patients with…
What are the side effects of Methotrexate?
The following adverse reactions are described, or described in greater detail, in other sections: • Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] • Myelosuppression [see Warnings and Precautions (5.4) ] • Serious Infections [see Warnings and Precautions (5.5) ] • Renal Toxicity [see Warnings and Precautions (5.6) ] • Hepatotoxicity [see Warnings and Precautions (5.7) ] •… See the full label for the complete list.
Who makes Methotrexate?
Methotrexate is listed by 27 labelers in the FDA NDC directory, including A-S Medication Solutions, Accord Healthcare Inc., Accord Healthcare, Inc., Alembic Pharmaceuticals Inc..
Has Methotrexate been recalled?
The FDA enforcement database lists 2 recalls for Methotrexate, most recently D-0553-2021 (class ii): CGMP Deviations: Intermittent exposure to temperature excursion during storage.