Skip to the answer

Methotrexate

Methotrexate is a folate-blocking medicine (an antimetabolite) used to treat certain cancers, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and severe psoriasis, depending on the product.

Brand names RheumatrexTrexallOtrexupRasuvoXatmep +2 more
Drug classes Folate Analog Metabolic Inhibitor
Rx Forms 3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 15 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

How we combine label and product data →
Other forms & routes:
Injection
Methotrexate at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Methotrexate is a folate-blocking medicine that slows fast-growing cells, used for certain cancers, rheumatoid arthritis, severe psoriasis and pJIA (a childhood arthritis); around since the 1950s and available generically, it is the usual first-choice drug for rheumatoid arthritis. Most people tolerate arthritis doses fairly well, though nausea, tiredness and mouth sores are common. Its boxed warning covers serious, even fatal, toxic reactions in the bone marrow, liver, lungs, skin and kidneys, plus harm or death to an unborn baby, so it is off-limits in pregnancy and lab monitoring is required. For arthritis and psoriasis it is taken once a week, and daily use by mistake has been fatal.

Clinical pearls

  • Call your prescriber promptly about a dry cough, mouth sores, diarrhea, fever, or unusual bruising or bleeding.
  • Ibuprofen, naproxen and aspirin can raise methotrexate levels and toxicity, most of all with high doses, so clear regular use first.
  • Remind dentists, surgeons and other prescribers you take it, since trimethoprim/sulfamethoxazole, penicillins and nitrous oxide anesthesia can raise its risks.
  • Skip over-the-counter vitamins containing folic acid unless your prescriber orders it, since extra folic acid may weaken methotrexate's effect.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Methotrexate can cause serious, even fatal, toxic reactions, and it can harm or kill an unborn baby. It should only be used under the care of a doctor experienced with this type of medicine. Otrexup's label limits its use to severe, disabling psoriasis or rheumatoid arthritis not helped by other treatments.

  • Pregnancy: it must not be used during pregnancy. Use effective contraception.
  • Kidney problems, ascites or pleural effusions slow its removal, so doses may need lowering.
  • NSAIDs taken with it (usually high-dose) have caused severe bone marrow and stomach/bowel toxicity.
  • Liver damage, including fibrosis and cirrhosis, can occur after long use.
  • Lung disease can occur at any time, even at low doses. Watch for a dry cough.
  • Diarrhea and mouth sores need treatment to be paused to avoid bowel perforation.
  • Lymphoma, tumor lysis syndrome, severe skin reactions, and serious infections (especially Pneumocystis pneumonia) can occur.
  • Combined with radiation, it may raise the risk of soft tissue and bone damage.
Read the full warning on DailyMed →
How you get itPrescription only
Comes asInjection, Tablet, Oral solution
Earliest FDA record1981
Companies listing it with the FDA32
FDA label last updatedAug 19, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide — a plain-language walkthrough of Methotrexate, written from its FDA label.

What Methotrexate is used for

▾

Methotrexate is used for several cancers and inflammatory conditions, depending on the product.

  • Acute lymphoblastic leukemia (ALL) as part of combination chemotherapy: tablets, Trexall, Jylamvo, Xatmep (children only) and methotrexate injection.
  • Mycosis fungoides and relapsed or refractory non-Hodgkin lymphoma: tablets, Trexall and Jylamvo.
  • Non-Hodgkin lymphoma, meningeal leukemia, osteosarcoma, breast cancer, head and neck squamous cell carcinoma and gestational trophoblastic neoplasia: methotrexate injection products.
  • Rheumatoid arthritis: tablets, Trexall, Jylamvo, Otrexup, Rasuvo and methotrexate injection.
  • Polyarticular juvenile idiopathic arthritis: tablets, Trexall, Jylamvo, Xatmep, Otrexup, Rasuvo and methotrexate injection.
  • Severe psoriasis: tablets, Trexall, Jylamvo, Otrexup, Rasuvo and methotrexate injection.
  • Otrexup and Rasuvo are not for cancer.

How Methotrexate works

▾

Methotrexate blocks dihydrofolate reductase, an enzyme that helps make the building blocks of DNA. Without them, cells cannot easily copy DNA or divide. Fast-growing cells, such as cancer cells, bone marrow and the lining of the mouth and gut, are the most sensitive.

In rheumatoid arthritis, how it works is unknown, but it may affect immune function.

Methotrexate dosage

▾

Methotrexate is taken by mouth or given by injection, depending on the product. Many uses call for once-weekly dosing, and daily use by mistake has been fatal. Cancer regimens vary and are set by your oncology team. Follow your prescriber's directions and the label exactly.

  • Otrexup and Rasuvo: once-weekly subcutaneous injection in the abdomen or thigh.
  • Xatmep and Jylamvo: oral liquid; use an accurate measuring device.
  • Food may delay absorption of oral methotrexate and lower peak levels.

Dosing details from the FDA-approved label

From the Methotrexate prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Acute Lymphoblastic Leukemia (ALL)
    • 20 mg/m2 orally once weekly, as part of a combination chemotherapy maintenance regimen
    • Periodically monitor absolute neutrophil count (ANC) and platelet count and adjust the dose to maintain ANC at a desirable level and for excessive myelosuppression
  • Mycosis Fungoides
    • 25 mg to 75 mg orally once weekly as a single agent, or 10 mg/m2 orally twice weekly as part of a combination chemotherapy regimen
  • Relapsed or Refractory Non-Hodgkin Lymphomas
    • 2.5 mg orally 2 to 4 times per week as part of a metronomic combination chemotherapy regimen
    • Maximum: 10 mg per week
  • Rheumatoid Arthritis
    • Starting dosage 7.5 mg orally once weekly with escalation to achieve optimal response
    • Dosages of more than 20 mg once weekly increase the risk of serious adverse reactions, including myelosuppression; administer folic acid or folinic acid
  • Polyarticular Juvenile Idiopathic Arthritis (pJIA)
    • Starting dose 10 mg/m2 orally once weekly with escalation to achieve optimal response
    • Dosages of more than 30 mg/m2 once weekly increase the risk of serious adverse reactions, including myelosuppression; administer folic acid or folinic acid
  • Psoriasis
    • 10 mg to 25 mg orally once weekly until an adequate response is achieved
    • Maximum: Do not exceed 30 mg per week
    • Adjust dose gradually; once optimal response achieved, reduce to lowest possible dosing regimen; administer folic acid or folinic acid supplementation
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Verify pregnancy status in females of reproductive potential before starting Methotrexate for 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 for 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 for Injection [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. • For patients switching between a methotrexate product administered orally and Methotrexate for 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 for Injection doses of 500 mg/m 2 or greater (e.g., high-dose) . • Consider leucovorin rescue for patients receiving Methotrexate for 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 for Injection regimens, follow the supportive care and monitoring instructions below. Also consider for patients receiving intermediate-dose Methotrexate for Injection regimens.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Methotrexate side effects

▾

Common side effects

  • Nausea and vomiting
  • Mouth sores (stomatitis)
  • Stomach pain or upset
  • Diarrhea
  • Fatigue and dizziness
  • Low white blood cell count
  • Rash
  • Hair loss

When to get medical help

  • Call your doctor right away for a dry, nonproductive cough or trouble breathing, which can signal lung problems.
  • Get help for diarrhea or mouth sores. These need treatment to be paused to avoid serious bowel damage.
  • Report fever, chills or signs of infection. Serious infections can happen.
  • Seek care for severe skin reactions, such as blistering, peeling or painful rash.
  • Tell your doctor about unusual bruising, bleeding or severe tiredness, which can signal low blood counts.
  • Report signs of liver or kidney trouble, as both can be affected.
  • Seek emergency help for an allergic reaction.
  • Call for help right away if you took more than prescribed, such as daily instead of weekly.

The most common side effects involve the mouth, stomach and blood counts.

  • Mouth sores
  • Nausea and vomiting
  • Stomach pain or indigestion
  • Diarrhea
  • Low white blood cells
  • Fatigue, dizziness, headache
  • Rash, hair loss, sun sensitivity
  • Raised liver tests

Call your doctor promptly about a dry cough, severe diarrhea or mouth sores, fever or infection, severe skin reactions, or unusual bruising or bleeding.

Methotrexate warnings and precautions

▾

Serious, sometimes fatal toxicity is the biggest risk. Methotrexate can harm the bone marrow, liver, lungs, skin and kidneys, and can harm an unborn baby.

  • Regular blood counts, kidney and liver tests are needed.
  • Mistaken daily dosing has been fatal.
  • Reduced kidney function slows its removal.
  • Dizziness and fatigue may affect driving.
  • It may affect fertility.

Methotrexate interactions

▾

Several drugs can raise methotrexate levels or add to its toxicity.

  • NSAIDs and aspirin: can raise levels, especially with high doses.
  • Proton pump inhibitors: may raise levels with high-dose use.
  • Penicillins and trimethoprim/sulfamethoxazole: can raise levels or suppress bone marrow.
  • Tetracycline and chloramphenicol: may lower absorption.
  • Azathioprine, retinoids, sulfasalazine: add liver risk.
  • Theophylline and mercaptopurine: levels may rise.
  • Folic acid vitamins: may reduce effect.
  • Nitrous oxide anesthesia: avoid.

Interactions listed in the FDA-approved label

From the Methotrexate prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Aspirin, NSAIDs, and steroids: Concomitant use may elevate and prolong serum methotrexate levels and cause increased toxicity; some NSAIDs with high dose methotrexate have been reported to cause deaths from severe hematologic and gastrointestinal toxicity. Do not give NSAIDs prior to or with high-dose methotrexate; use caution with lower doses; aspirin, NSAIDs, and/or low dose steroids may be continued in rheumatoid arthritis.
  • Proton pump inhibitors (e.g., omeprazole, esomeprazole, pantoprazole): Concomitant use, primarily with high-dose methotrexate, may elevate and prolong serum levels of methotrexate and/or hydroxymethotrexate, possibly leading to toxicities. Use caution if high-dose methotrexate is given to patients receiving PPI therapy.
  • Oral antibiotics (tetracycline, chloramphenicol, nonabsorbable broad spectrum antibiotics): May decrease intestinal absorption of methotrexate or interfere with enterohepatic circulation.
  • Penicillins: May reduce renal clearance of methotrexate; increased serum concentrations with hematologic and gastrointestinal toxicity have been observed. Should be carefully monitored.
  • Trimethoprim/sulfamethoxazole: Has been reported rarely to increase bone marrow suppression in patients receiving methotrexate.
  • Hepatotoxins (e.g., azathioprine, retinoids, sulfasalazine): Potential for increased hepatotoxicity; hepatotoxicity has been reported in such cases. Closely monitor for possible increased risk of hepatotoxicity.
  • Theophylline: Methotrexate may decrease the clearance of theophylline. Monitor theophylline levels when used concurrently.
  • Folic acid and antifolates: Vitamin preparations containing folic acid or its derivatives may decrease responses to systemic methotrexate; folate deficiency states may increase methotrexate toxicity.
  • Mercaptopurine: Methotrexate increases the plasma levels of mercaptopurine. The combination may require dose adjustment.
  • Nitrous oxide: Potentiates the effect of methotrexate on folate dependent metabolic pathways, with potential for increased toxicity. Avoid concomitant nitrous oxide anesthesia.
Read the label’s full interactions text

7 DRUG INTERACTIONS Aspirin, NSAIDs, and steroids: concomitant use may elevate and prolong serum methotrexate levels and cause increased toxicity ( 7.1 ). Proton pump inhibitors : concomitant use may elevate and prolong serum methotrexate levels and cause increased toxicity ( 7.2 ). 7.1 Aspirin, Nonsteroidal Anti-Inflammatory Drugs, and Steroids Nonsteroidal anti-inflammatory drugs (NSAIDs) should not be administered prior to or concomitantly with the high doses of methotrexate, such as used in the treatment of osteosarcoma. Concomitant administration of some NSAIDs with high dose methotrexate therapy has been reported to elevate and prolong serum methotrexate levels, resulting in deaths from severe hematologic and gastrointestinal toxicity [see Warnings and Precautions ( 5.1 )]. Caution should be used when NSAIDs and salicylates are administered concomitantly with lower doses of methotrexate, including Otrexup. These drugs have been reported to reduce the tubular secretion of methotrexate in an animal model and may enhance its toxicity. Despite the potential interactions, studies of methotrexate in patients with rheumatoid arthritis have usually included concurrent use of constant dosage regimens of NSAIDs, without apparent problems. It should be appreciated, however, that the doses used in rheumatoid arthritis (7.5 to 15 mg/week) are somewhat lower than those used in psoriasis and that larger doses could lead to unexpected toxicity. 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. Steroids may be reduced gradually in patients who respond to methotrexate. 7.2 Proton Pump Inhibitors (PPIs) Use caution if high-dose methotrexate is administered to patients receiving proton pump inhibitor (PPI) therapy.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿82 supplements and herbs with documented Methotrexate interactions, ranked by severity Check Methotrexate against a supplement or herb →

Before taking Methotrexate

▾
  • Do not use during pregnancy.
  • Use effective contraception during and after treatment (men and women).
  • Do not breastfeed during treatment and for a period afterward.
  • Tell your doctor about kidney or liver disease, or fluid buildup.
  • Otrexup is contraindicated with alcoholism, chronic liver disease, immunodeficiency or existing blood disorders.
  • Do not use if allergic to methotrexate.
  • Older adults may need lower doses and closer monitoring.
  • Use caution with peptic ulcer disease or ulcerative colitis.

Methotrexate overdose

▾

Too much methotrexate, often from taking it daily instead of weekly, can cause low blood counts, mouth sores, nausea, vomiting and stomach bleeding. Deaths have been reported. Leucovorin is the antidote and works best when started as soon as possible, so get emergency help right away.

What Methotrexate does in the body

▾

By blocking folate-dependent DNA building, methotrexate slows fast-dividing cells. In psoriasis, skin cells multiply too quickly, which is the basis for its use. In osteosarcoma, high doses are followed by leucovorin rescue to protect normal tissues. Its effect on immune activity in rheumatoid arthritis is not fully understood.

How your body processes Methotrexate

▾

Oral methotrexate is absorbed best at lower doses, peaking in about one to two hours, and food can delay absorption. Injected forms are generally completely absorbed. It is processed in the liver and cells, and its half-life is about three to ten hours at lower doses. Kidney problems slow its clearance.

How to store Methotrexate

▾

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) . Protect from light. store multiple-dose vials at 2°C to 8°C, and use within 30 days.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

82

Supplements & herbs that interact with Methotrexate

82 supplements and herbal products have documented interactions with Methotrexate in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 7
  • Moderate · 60
  • Minor · 15
ACTIVATED CHARCOAL Major APPLE Major BEER Major GRAPEFRUIT Major SIBERIAN COCKLEBUR Major SWEET ORANGE Major WINE Major AFRICAN WILD POTATO Moderate +74 more
Every supplement checked against Methotrexate — ranked by severity The full interaction hub: 7 major · 60 moderate · 15 minor · every one linked to its full report. Check Methotrexate against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Methotrexate has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

FOLIC ACID Major Depletion
See the full Methotrexate nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Methotrexate: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Methotrexate — the kind of thing our pharmacy team would talk through with you at the counter.

What is methotrexate used for?

▾
It treats certain cancers, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and severe psoriasis. Which use applies depends on the product you were given. Otrexup and Rasuvo, for example, are not used for cancer.

How often do I take it?

▾
For many uses, such as arthritis and psoriasis, it is taken once a week, not daily. Taking it daily by mistake has caused deaths. Follow your prescriber's schedule exactly, and ask me if you are unsure.

What side effects are normal?

▾
Nausea, stomach upset, mouth sores, tiredness, dizziness, rash and hair loss are common. Call your doctor about a dry cough, bad diarrhea, fever, severe skin reactions or unusual bleeding or bruising.

Can I take ibuprofen or other pain relievers with it?

▾
NSAIDs and aspirin can raise methotrexate levels and increase toxicity, so check with your prescriber or pharmacist first. This matters most at high methotrexate doses. Also tell us about antibiotics, acid reducers and folic acid vitamins.

Is it safe in pregnancy?

▾
No. Methotrexate can cause birth defects and fetal death, and it should not be used during pregnancy. Both women and men should use effective contraception during and after treatment, and breastfeeding is not advised.

Why do I need blood tests?

▾
Methotrexate can affect your blood counts, liver and kidneys, sometimes without symptoms. Regular tests help catch problems early, when most reactions can be reversed.

Is Methotrexate available over the counter?

▾
No. Methotrexate is a prescription medicine: every Methotrexate product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Methotrexate first available?

▾
The earliest FDA record we hold for Methotrexate is from 1981: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Methotrexate was first used.

Who makes Methotrexate?

▾
32 companies currently list Methotrexate products in the FDA's NDC Directory, including Medexus Pharma Inc., Antares Pharma, Inc., Hikma Pharmaceuticals USA Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Methotrexate on HelloPharmacist

📊Methotrexate supplement interactions82 checked — ranked by severity 🌿Drug & Supplement CheckerMethotrexate vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Methotrexate NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Methotrexate Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Methotrexate forms and strengths (how it comes)

Methotrexate is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

By injection · Into a muscle · Into a vein · Into the fluid around the spinal cord · Intra-Arterial · Under the skin
Brands Otrexup Rasuvo
How this form is used
What it may be used for
  • Otrexup and Rasuvo are used for severe, active rheumatoid arthritis and pJIA after first-line therapy, and for severe, disabling psoriasis in adults.
  • Otrexup and Rasuvo are not for cancer.
  • Methotrexate injection is used for several cancers, plus rheumatoid arthritis, pJIA and severe psoriasis.
Important instructions
  • Otrexup and Rasuvo are for once-weekly subcutaneous use only, in the abdomen or thigh.
  • Otrexup and Rasuvo are single-dose auto-injectors.
  • For oral, intramuscular, intravenous, intra-arterial or intrathecal dosing, another methotrexate formulation is needed instead of Otrexup or Rasuvo.
  • Methotrexate injection can be given by routes including intramuscular, intravenous and subcutaneous, depending on the condition.
Available strengths 22 strengths
7.5 mg/0.15 mL 10 mg/0.2 mL 10 mg/0.4 mL 12.5 mg/0.4 mL 12.5 mg/0.25 mL 15 mg/0.3 mL
Show 16 more strengths Show fewer strengths
15 mg/0.4 mL 17.5 mg/0.4 mL 17.5 mg/0.35 mL 20 mg/0.4 mL 22.5 mg/0.4 mL 22.5 mg/0.45 mL 25 mg/0.4 mL 25 mg/0.5 mL 25 mg/25 mg 25 mg/mL 30 mg/0.6 mL 50 mg/2 mL 100 mg/4 mL 200 mg/8 mL 250 mg/10 mL 1 g
99 FDA-listed product records ⓘ

Tablet

By mouth
Brands Trexall
How this form is used
What it may be used for
  • Methotrexate tablets and Trexall are used for ALL, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis, pJIA and severe psoriasis.
Important instructions
  • Trexall and methotrexate tablets are taken by mouth, and many uses call for once-weekly dosing.
  • Take Trexall and methotrexate tablets exactly as directed, because medication errors have led to deaths.
Available strengths 5 strengths
2.5 mg 5 mg 7.5 mg 10 mg 15 mg
67 FDA-listed product records ⓘ

Oral solution

By mouth
Brands Jylamvo Xatmep
How this form is used
What it may be used for
  • Jylamvo is used for ALL, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis, pJIA and severe psoriasis.
  • Xatmep is used for ALL and pJIA in children only.
Important instructions
  • Xatmep is for oral use only and should be taken weekly as directed.
  • Xatmep must be measured with an accurate measuring device; a household teaspoon is not accurate.
  • Jylamvo: follow directions exactly, because medication errors have led to deaths.
Available strengths 2 strengths
2 mg/mL 2.5 mg/mL
4 FDA-listed product records ⓘ

Methotrexate on the U.S. market: products, makers and brands

How Methotrexate appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

32 companies list 75 Methotrexate product records with the FDA, mostly as injection, tablet, oral solution; the earliest marketing or approval year on record is 1981. Brand names on the directory include Rheumatrex, Trexall, Otrexup and 4 more; the rest are generics.

3
Dose forms ⓘ
32
Labelers (makers, repackagers, distributors)
7
Brand names
75
FDA-listed product records ⓘ
1981
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (19) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Medexus Pharma Inc.12%
Antares Pharma, Inc.9%
Hikma Pharmaceuticals USA Inc.9%
Bryant Ranch Prepack8%
Eugia US LLC5%
Hospira, Inc.5%
Other makers51%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Methotrexate is used (Medicaid data)

A general measure of how commonly Methotrexate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Methotrexate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

533,549
Medicaid prescriptions filled (Q1–Q4 2025)
$21M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Methotrexate prescribed? Of the 1,601 medications we measure, Methotrexate ranks #256 by Medicaid prescriptions — more than 84% of them.

Where Methotrexate ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #256 of 1,601
#251 Isosorbide 563,613 Rx #252 Morphine 562,550 Rx #253 Chlorthalidone 561,590 Rx #254 Bisacodyl 542,387 Rx #255 Metronidazole Vaginal 541,965 Rx #256 Methotrexate 533,549 Rx #257 Labetalol 525,457 Rx #258 Propofol 520,319 Rx #259 Pioglitazone 511,848 Rx #260 Dextromethorphan / Gua... 511,044 Rx #261 Clobazam 496,684 Rx

Utilization by Methotrexate product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 2.5 mg oral tablet is the most-dispensed Methotrexate product — about 84% of these Medicaid prescriptions.

methotrexate 2.5 MG Oral Tablet Most dispensed

447,780 Medicaid prescriptions (Q1–Q4 2025) 84% of Methotrexate prescriptions shown $6.6M gross reimbursement (before rebates) ≈ $15 per prescription (gross)

Summed across the 14 of 104 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 105585

methotrexate 25 MG/ML Injectable Solution

45,479 Medicaid prescriptions (Q1–Q4 2025) 9% of Methotrexate prescriptions shown $798,953 gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 3 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1946772

2 ML methotrexate 25 MG/ML Injection

17,224 Medicaid prescriptions (Q1–Q4 2025) 3% of Methotrexate prescriptions shown $239,595 gross reimbursement (before rebates) ≈ $14 per prescription (gross)

Summed across the 3 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1655960

0.5 ML methotrexate 50 MG/ML Auto-Injector

4,459 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $2.9M gross reimbursement (before rebates) ≈ $650 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1544397

0.4 ML methotrexate 50 MG/ML Auto-Injector

3,687 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $2.4M gross reimbursement (before rebates) ≈ $660 per prescription (gross)

Summed across the 2 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1441416

methotrexate 2.5 MG/ML Oral Solution

3,656 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $2.5M gross reimbursement (before rebates) ≈ $689 per prescription (gross)

Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1921592

0.3 ML methotrexate 50 MG/ML Auto-Injector

2,633 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $1.6M gross reimbursement (before rebates) ≈ $626 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1544387

methotrexate 10 MG Oral Tablet

1,849 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $793,563 gross reimbursement (before rebates) ≈ $429 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 105586

0.2 ML methotrexate 50 MG/ML Auto-Injector

987 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $626,031 gross reimbursement (before rebates) ≈ $634 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1544378

methotrexate 15 MG Oral Tablet

959 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $393,419 gross reimbursement (before rebates) ≈ $410 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 283510

40 ML methotrexate 25 MG/ML Injection

787 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $17,065 gross reimbursement (before rebates) ≈ $22 per prescription (gross)

Summed across the 2 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1655956

10 ML methotrexate 25 MG/ML Injection

679 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $10,052 gross reimbursement (before rebates) ≈ $15 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1655959

0.25 ML methotrexate 50 MG/ML Auto-Injector

561 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $365,423 gross reimbursement (before rebates) ≈ $651 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1544385

methotrexate 5 MG Oral Tablet

541 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $210,986 gross reimbursement (before rebates) ≈ $390 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 283511

0.4 ML methotrexate 62.5 MG/ML Auto-Injector

507 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $440,023 gross reimbursement (before rebates) ≈ $868 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1441422

0.35 ML methotrexate 50 MG/ML Auto-Injector

464 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $288,101 gross reimbursement (before rebates) ≈ $621 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1544389

methotrexate 7.5 MG Oral Tablet

462 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $101,545 gross reimbursement (before rebates) ≈ $220 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 283671

0.4 ML methotrexate 37.5 MG/ML Auto-Injector

348 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $285,324 gross reimbursement (before rebates) ≈ $820 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1441411

0.45 ML methotrexate 50 MG/ML Auto-Injector

203 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $131,476 gross reimbursement (before rebates) ≈ $648 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1544395

0.15 ML methotrexate 50 MG/ML Auto-Injector

187 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $114,241 gross reimbursement (before rebates) ≈ $611 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1544403

methotrexate 1000 MG Injection

42 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $92 gross reimbursement (before rebates) ≈ $2.20 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311625

0.4 ML methotrexate 25 MG/ML Auto-Injector

40 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $34,871 gross reimbursement (before rebates) ≈ $872 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1441402

0.4 ML methotrexate 43.8 MG/ML Auto-Injector

15 Medicaid prescriptions (Q1–Q4 2025) <1% of Methotrexate prescriptions shown $13,522 gross reimbursement (before rebates) ≈ $901 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1747185

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Methotrexate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 44 of 192 listed Methotrexate NDCs with Medicaid activity.

Compare Methotrexate products

A representative set of FDA-listed product records for Methotrexate — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 75 of 75 products — FDA National Drug Code Directory. See every product, package size and price: browse all 75 Methotrexate NDCs →

Methotrexate recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list one Methotrexate recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class III Sep 22, 2023 · West-Ward Columbus Inc
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
  • Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25 Lots: Lot, expiry: Lot AB7486B, exp Dec 2023; Lot AB8766B, exp April 2024; Lot AB9484B, exp Aug 2024 FDA record D-0066-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Methotrexate RxCUI 6851 6 dose forms · 39 strengths
  1. Dose form (SCDF) Auto-Injector RxCUI 1655203 In current FDA listings
    Clinical drug / strength (SCD) 0.15 ML methotrexate 50 MG/ML RxCUI 1544403 0.2 ML methotrexate 50 MG/ML RxCUI 1544378 0.25 ML methotrexate 50 MG/ML RxCUI 1544385 0.3 ML methotrexate 50 MG/ML RxCUI 1544387 0.35 ML methotrexate 50 MG/ML RxCUI 1544389 0.4 ML methotrexate 25 MG/ML RxCUI 1441402 0.4 ML methotrexate 31.3 MG/ML RxCUI 1747179 0.4 ML methotrexate 37.5 MG/ML RxCUI 1441411 0.4 ML methotrexate 43.8 MG/ML RxCUI 1747185 0.4 ML methotrexate 50 MG/ML RxCUI 1441416 0.4 ML methotrexate 56.3 MG/ML RxCUI 1747192 0.4 ML methotrexate 62.5 MG/ML RxCUI 1441422 0.45 ML methotrexate 50 MG/ML RxCUI 1544395 0.5 ML methotrexate 50 MG/ML RxCUI 1544397 0.6 ML methotrexate 50 MG/ML RxCUI 1544401
  2. Dose form (SCDF) Injectable Solution RxCUI 372835 In current FDA listings
    Clinical drug / strength (SCD) 2.5 MG/ML RxCUI 315148 25 MG/ML RxCUI 1946772 100 MG/ML RxCUI 105589
  4. Dose form (SCDF) Oral Solution RxCUI 1921591 In current FDA listings
    Clinical drug / strength (SCD) 2 MG/ML RxCUI 2671456 2.5 MG/ML RxCUI 1921592
  5. Dose form (SCDF) Oral Tablet RxCUI 372836 In current FDA listings
    Clinical drug / strength (SCD) 2.5 MG RxCUI 105585 5 MG RxCUI 283511 7.5 MG RxCUI 283671 10 MG RxCUI 105586 15 MG RxCUI 283510
  6. Dose form (SCDF) Prefilled Syringe RxCUI 2377332 No current FDA listing
    Clinical drug / strength (SCD) 0.3 ML methotrexate 25 MG/ML RxCUI 2377353 0.4 ML methotrexate 25 MG/ML RxCUI 2377333 0.5 ML methotrexate 25 MG/ML RxCUI 2377341 0.6 ML methotrexate 25 MG/ML RxCUI 2377343 0.7 ML methotrexate 25 MG/ML RxCUI 2377345 0.8 ML methotrexate 25 MG/ML RxCUI 2377347 0.9 ML methotrexate 25 MG/ML RxCUI 2377349 1 ML methotrexate 25 MG/ML RxCUI 2377351

Look up RxCUI 6851 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Methotrexate brand names

Methotrexate is sold under 7 brand names in the FDA directory — Rheumatrex, Trexall, Otrexup, Rasuvo and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Rheumatrex Trexall Otrexup Rasuvo Xatmep Reditrex Jylamvo

Who makes Methotrexate: manufacturers and labelers

32 companies list Methotrexate products with the FDA. By number of product records, the largest are Medexus Pharma Inc., Antares Pharma, Inc., Hikma Pharmaceuticals USA Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Medexus Pharma Inc. 9 Antares Pharma, Inc. 7 Hikma Pharmaceuticals USA Inc. 7 Bryant Ranch Prepack 6 Eugia US LLC 4 Hospira, Inc. 4 Teva Women's Health LLC 4 Alembic Pharmaceuticals Inc. 3 Alembic Pharmaceuticals Limited 3 Teva Parenteral Medicines, Inc. 3 Accord Healthcare Inc. 2 Fresenius Kabi USA, LLC 2 NuCare Pharmaceuticals, Inc. 2 A-S Medication Solutions 1 Aurobindo Pharma Limited 1 AvKARE 1 AvPAK 1 Azurity Pharmaceuticals, Inc. 1 Chartwell RX, LLC 1 Coupler LLC 1 Elite Laboratories, Inc. 1 Golden State Medical Supply, Inc. 1 Major Pharmaceuticals 1 Mylan Institutional Inc. 1

…and 8 more on the FDA NDC directory.

Methotrexate drug class (RxNorm)

Methotrexate belongs to the Folate Analog Metabolic Inhibitor class.

Pharmacologic class Folate Analog Metabolic Inhibitor
Drug family (ATC) Folic acid analogues, Other immunosuppressants
How it works Folic Acid Metabolism Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Methotrexate page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Aug 19, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Methotrexate.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Methotrexate after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
15
Finished products in the current FDA directory
75
Companies listing them (makers, repackagers, distributors)
32
FDA labeler codes behind them ⓘ
34
Linked representative label ⓘ
Fresenius Kabi USA, LLC
Linked label effective
Aug 19, 2025
Composite sections available
25
Linked SPL Set ID
ec476b11-0b3c-4139-b1eb-a3daa76bc271
Linked SPL Document ID
3d21237a-ef53-4592-bf06-0c739696203d
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Fresenius Kabi USA, LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →