What is methotrexate?

XATMEP contains methotrexate, a folate analog metabolic inhibitor. Chemically methotrexate is N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]-benzoyl]-L-glutamic acid. The structural formula is: XATMEP is a clear yellow to orange oral solution that contains 2.5 mg of methotrexate per milliliter (equivalent to 2.74 mg of methotrexate sodium/mL). Inactive ingredients include purified water, sodium citrate, citric acid, methylparaben sodium, propylparaben sodium, and sucralose. It may also contain sodium hydroxide or hydrochloric acid for pH adjustment. structure

What kind of drug is methotrexate?

The FDA classifies methotrexate as a folate analog metabolic inhibitor. Folate analog metabolic inhibitors like methotrexate block the enzyme that converts folate into its usable form, starving fast-dividing cells of the building blocks for DNA. At low doses they also calm an overactive immune system and reduce inflammation. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take methotrexate with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run methotrexate against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is methotrexate sold under?

We track 10 methotrexate-containing products in the U.S.: Xatmep, Methotrexate Lpf, Methotrexate Preservative Free, Abitrexate, Jylamvo, Methotrexate Sodium, Otrexup and Otrexup Pfs, and 2 more. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does methotrexate come in?

Across the brands we track, methotrexate is currently marketed as solution, injectable and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic methotrexate?

Yes. Our catalog lists 2 generic methotrexate products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.

Has methotrexate been recalled?

The FDA's Enforcement database lists 1 recall record whose product description mentions methotrexate. The most recent: Methotrexate Tablets (Aug 1, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.

Methotrexate: uses, dosing, side effects & brands

Methotrexate is a folate analog metabolic inhibitor sold in the U.S. under 10 brand and generic names, for juvenile arthritis, rheumatoid arthritis and breast neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesHow we research

Key facts

Drug class: Folate Analog Metabolic Inhibitor
Treats: Juvenile Arthritis, Rheumatoid Arthritis and Breast Neoplasms
Available as: Solution · Injectable · Tablet
Sold as: 10 products — Xatmep, Methotrexate Lpf and Methotrexate Preservative Free, and others
Prescription?: Prescription only
Generic available?: Yes
Typical price: about $5 for a 30-count supply
Boxed warning: Boxed warning

How methotrexate is dosed

From the FDA label for Xatmep (application NDA208400). Other methotrexate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Use another formulation of methotrexate for patients requiring dosing via routes of administration other than oral ( 2.1 ). Measure with an accurate measuring device ( 2.1 ). Recommended Dosage: ALL: 20 mg/m 2 one time weekly ( 2.2 ). pJIA: Starting dose of 10 mg/m 2 one time weekly ( 2.3 ). 2.1 Important Administration Information XATMEP is intended for oral use only. Use another formulation of methotrexate for alternative dosing in patients who require dosing via other routes of administration. Instruct patients and caregivers that the recommended dose should be taken weekly, as directed, and that mistaken daily use of the recommended dose has led to fatal toxicity [see Warnings and Precautions ( 5.15 ), Overdosage ( 10 )]. It is important that XATMEP be measured with an accurate measuring device [see Warnings and Precautions ( 5.15 ), Patient Counseling Information ( 17 )] . A household teaspoon is not an accurate measuring device. A pharmacist can provide an appropriate device and can provide instructions for measuring the correct dose. 2.2 Acute Lymphoblastic Leukemia The recommended starting dose of XATMEP, in multi-agent combination chemotherapy maintenance regimens, is 20 mg/m 2 given one time weekly. After initiating XATMEP, continuation of appropriate dosing requires periodic monitoring of absolute neutrophil count (ANC) and platelet count to assure sufficient drug…

Methotrexate side effects

The following adverse reactions are discussed in more detail in other sections of the labeling. Bone Marrow Suppression [see Warnings and Precautions ( 5.1 )] Serious Infections [see Warnings and Precautions ( 5.2 )] Renal Toxicity and Increased Toxicity with Renal Impairment [see Warnings and Precautions ( 5.3 )] Gastrointestinal Toxicity [see Warnings and Precautions ( 5.4 )] Hepatic Toxicity [see Warnings and Precautions ( 5.5 )] Pulmonary Toxicity [see Warnings and Precautions ( 5.6 )] Hypersensitivity and Dermatologic Reactions [see Warnings and Precautions ( 5.7 )] Secondary Malignancies [see Warnings and Precautions ( 5.8 )] Ineffective Immunization and Risks Associated with Live Vaccines [see Warnings and Precautions ( 5.10 )] Infertility [see Warnings and Precautions ( 5.11 )] Increased Toxicity Due to Third‑Space Accumulation [see Warnings and Precautions ( 5.12 )] Soft Tissue and Bone Toxicity with Radiation Therapy [see Warnings and Precautions ( 5.13 )] Most common adverse reactions are: ulcerative stomatitis, leukopenia, nausea, abdominal distress, and elevated liver function tests. Other frequently reported adverse reactions are malaise, fatigue, chills and fever, dizziness and decreased resistance to infection ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc., at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.…

Every methotrexate product we track (10)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Methotrexate products
#	Drug	Rating	Type	Form	Generic?	Typical price
1	Xatmep Boxed warning	72/100	Prescription	Solution	Generic	$5	View →
2	Methotrexate Lpf

What methotrexate pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Methotrexate pill imprints
Imprint	Strength	Colour	Shape	Maker
ORN57	2.5 mg	yellow	round	—
54323	2.5 mg	yellow	round	—
54323	2.5 mg	yellow	round	—
E2	2.5 mg	yellow	round	—
ORN57	2.5 mg	yellow	round	—
b;572	2.5 mg

Methotrexate recalls

From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.

Methotrexate Tablets
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Amneal Pharmaceuticals, LLC · Aug 1, 2024

Frequently asked questions

What is methotrexate?: XATMEP contains methotrexate, a folate analog metabolic inhibitor. Chemically methotrexate is N-[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]-benzoyl]-L-glutamic acid. The structural formula is: XATMEP is a clear yellow to orange oral solution that contains 2.5 mg of methotrexate per milliliter (equivalent to 2.74 mg of methotrexate sodium/mL). Inactive ingredients include purified water, sodium citrate, citric acid, methylparaben sodium, propylparaben sodium, and sucralose. It may also contain sodium hydroxide or hydrochloric acid for pH adjustment. structure
What kind of drug is methotrexate?: The FDA classifies methotrexate as a folate analog metabolic inhibitor. Folate analog metabolic inhibitors like methotrexate block the enzyme that converts folate into its usable form, starving fast-dividing cells of the building blocks for DNA. At low doses they also calm an overactive immune system and reduce inflammation. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take methotrexate with other medicines?: It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run methotrexate against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is methotrexate sold under?: We track 10 methotrexate-containing products in the U.S.: Xatmep, Methotrexate Lpf, Methotrexate Preservative Free, Abitrexate, Jylamvo, Methotrexate Sodium, Otrexup and Otrexup Pfs, and 2 more. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does methotrexate come in?: Across the brands we track, methotrexate is currently marketed as solution, injectable and tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.