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Prescription medicine

Methotrexate Brand names: Rasuvo, Otrexup, Jylamvo, Xatmep, Trexall

Methotrexate (Rasuvo) is a prescription medicine with an FDA approval on record since 1953. FDA's NDC Directory lists it from 29 generic labelers, and pharmacies paid $0.158 per methotrexate 2.5 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $21.76 per mL (Xatmep 2.5 mg/mL oral solution).

  • Generic listed
  • In shortage
  • Boxed warning

Check it at the source: the methotrexate FDA label on DailyMed (effective May 27, 2026, Accord Healthcare Inc.); the NDA 8085 record on Drugs@FDA; every methotrexate label on DailyMed.

Highlights of the record

FDA label of May 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Boxed warning

EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, SEVERE ADVERSE REACTIONS,.

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

Used for

From the label: indications and usage

Methotrexate tablets is a dihydrofolate reductase inhibitor indicated for the: Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen ( 1.1 ) Treatment of adults with mycosis fungoides ( 1.1 ) Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen ( 1.1 ) Treatment of adults

Forms and strengths

  • 1 g
  • 2.5 mg
  • 5 mg
  • 7.5 mg
  • 15 mg
  • 2 mg/ml
  • 2.5 mg/ml
  • 7.5 mg/.15ml
  • 10 mg/.2ml
  • 10 mg/.4ml
  • 12.5 mg/.4ml
  • 15 mg/.4ml

Injection (solution); tablet; solution; film-coated tablet; injection (powder) (lyophilized) for solution.

On the market

Earliest approval on file
December 7, 1953 Methotrexate Sodium, Strides Pharma Intl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
42 first September 5, 1979; 25 with a marketed status in Drugs@FDA
Labelers listed (NDC)
34 of which 29 under generic applications, 5 under brand applications, repackagers included
Last listed patent
June 1, 2029 Rasuvo injection; not a generic launch date

Supply and safety

Pharmacy cost (NADAC)
$0.158 per tablet Methotrexate 2.5 mg tablet
Shortage (FDA)
7 of 14 presentations limited or unavailable updated October 6, 2026
Recalls by its makers (FDA)
8 since 2012 2 Class I among all firms' recalls; latest August 1, 2024; 2 more by firms not listed as its makers
FAERS reports
489,791 through July 30, 2026

What is methotrexate used for?

From the label: indications and usage

Methotrexate tablets is a dihydrofolate reductase inhibitor indicated for the: Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen ( 1.1 ) Treatment of adults with mycosis fungoides ( 1.1 ) Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen ( 1.1 ) Treatment of adults with rheumatoid arthritis ( 1.2 ) Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) ( 1.3 ) Treatment of adults with severe psoriasis ( 1.4 ) 1.1 Neoplastic Diseases is indicated for the: Methotrexate Tablets is indicated for the: treatment […]

Conditions named in the indications of methotrexate's FDA labels, with every medicine labeled for each:

From other methotrexate labels

Psoriasis: … n regimen ( 1.1 ) Treatment of adults with rheumatoid arthritis ( 1.2 ) Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) ( 1.3 ) Treatment of adults with severe […]

Breast cancer: Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly …

FDA pharmacologic class: Folate Analog Metabolic Inhibitor.

Source: FDA drug label (Methotrexate), Accord Healthcare Inc., effective May 27, 2026 (SPL set 874c7f43-a3be-4236-89cc-24c44e3c5813), via openFDA; the full label on DailyMed

What does the patient leaflet for methotrexate say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about Methotrexate?

Methotrexate can cause serious side effects that may be severe and lead to death, including: Harm to an unborn baby, including birth defects or death of an unborn baby. Females who can become pregnant: Your healthcare provider should do a pregnancy test before you start taking Methotrexate to see if you are pregnant. If you are being treated for a medical condition other than cancer, do not take Methotrexate if you are pregnant. See Who should not take Methotrexate? If you are taking Methotrexate to treat your cancer, you and your healthcare provider will decide if you will take Methotrexate if you are pregnant. Use effective birth control (contraception) during treatment and for 6 months after your final dose of Methotrexate. Ask your healthcare provider what forms of birth control you can use during this time. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Methotrexate. Males with female partners who are able to become pregnant: Use effective birth control during treatment and for 3 months after your final dose of Methotrexate. Tell your healthcare provider right away if your female partner becomes pregnant during treatment with Methotrexate. Severe allergic reactions. Severe allergic reactions can happen with Methotrexate. Signs and symptoms of a severe allergic reaction may include: skin rash, itching and hives swelling of the face, lips, tongue, or throat dizziness trouble breathing wheezing fast heart rate feeling faint stomach-area pain vomiting or diarrhea Do not take Methotrexate if you have had a severe allergic reaction to Methotrexate in the past. Get medical help right away if you develop any of the signs or symptoms of a severe allergic reaction listed above. Decreased blood cell counts. […]

From the patient leaflet: How should I store Methotrexate tablets?

Store Methotrexate tablets at 68°F to 77°F (20°C to 25°C). Keep Methotrexate tablets away from light. Keep Methotrexate and all medicines out of the reach of children.

Source: FDA drug label (Methotrexate), Accord Healthcare Inc., effective May 27, 2026 (SPL set 874c7f43-a3be-4236-89cc-24c44e3c5813), via openFDA; the full label on DailyMed

Is there a generic for methotrexate (Rasuvo)?

The FDA approved the first generic methotrexate on September 5, 1979. 42 generic applications are approved; 25 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists methotrexate from 29 labelers under a generic (ANDA) application and from 5 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

The Orange Book lists 1 patent for Rasuvo injection, the last expiring on June 1, 2029; a patent listed only for Jylamvo oral solution runs to October 28, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

  • 1953 earliest approval on file
  • 1979 first generic approved
  • 2029 last listed patent
  • 2023 to now in shortage
  • red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for methotrexate (Rasuvo)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.158 per Methotrexate 2.5 mg tablet, down 4% from $0.164 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

  • Methotrexate 2.5 mg tablet (generic)
  • Xatmep 2.5 mg/mL oral solution (brand)
$21.76
$0.151
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Methotrexate 2.5 mg tabletGeneric$0.158 per tablet$4.73-4%
Methotrexate 250 mg/10 mL vialGeneric$0.702 per mL$7.02 per vial-64%
Methotrexate 50 mg/2 mL vialGeneric$2.49 per mL$4.99 per vial-0.6%
Rasuvo 10 mg/0.2 mL autoinjBrand$721.81 per mL$144.36 per autoinj+3%
Rasuvo 12.5 mg/0.25 mL autoinjBrand$574.87 per mL$143.72 per autoinj+2%
Rasuvo 15 mg/0.3 mL autoinjBrand$480.00 per mL$144.00 per autoinj+2%
Rasuvo 17.5 mg/0.35 mL autoinjBrand$409.93 per mL$143.48 per autoinj+2%
Rasuvo 20 mg/0.4 mL autoinjBrand$362.29 per mL$144.91 per autoinj+3%
Rasuvo 25 mg/0.5 mL autoinjBrand$289.37 per mL$144.68 per autoinj+3%
Rasuvo 7.5 mg/0.15 mL autoinjBrand$960.29 per mL$144.04 per autoinj+3%
Trexall 10 mg tabletBrand$48.14 per tablet many times the lowest per-tablet cost; NADAC records the price, not why$1,444.06+9%
Trexall 5 mg tabletBrand$24.09 per tablet many times the lowest per-tablet cost; NADAC records the price, not why$722.65+9%
Trexall 7.5 mg tabletBrand$36.21 per tablet many times the lowest per-tablet cost; NADAC records the price, not why$1,086.27n/a
Xatmep 2.5 mg/mL oral solutionBrand$21.76 per mLn/an/a

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Is methotrexate in shortage?

The FDA Drug Shortage Database lists 7 of 14 methotrexate presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on March 13, 2023. 7 more presentations are on the list as available.

PresentationCompanyStatusUpdated
Methotrexate Preservative Free, Injection, 1 g (NDC 63323-122-50)Fresenius Kabi USA, LLCCurrentOctober 6, 2026
Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3671-01)Teva Pharmaceuticals USA, Inc.CurrentOctober 1, 2026
Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3675-01)Teva Pharmaceuticals USA, Inc.CurrentOctober 1, 2026
Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 0703-3678-01)Teva Pharmaceuticals USA, Inc.CurrentOctober 1, 2026
Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 16729-277-30)Accord Healthcare Inc.CurrentOctober 3, 2026
Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 16729-277-35)Accord Healthcare Inc.CurrentOctober 3, 2026
Methotrexate Sodium, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-124-40)Hospira, Inc., a Pfizer CompanyCurrentSeptember 22, 2026
Methotrexate Sodium, Injection, 1 g/40 mL (25 mg/mL) (NDC 61703-408-25)Hospira, Inc., a Pfizer CompanyCurrentSeptember 22, 2026

Every methotrexate presentation in the FDA shortage database

Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026

Has methotrexate been recalled?

The FDA's Enforcement Report lists 10 recalls naming methotrexate since 2012: 2 Class I (the most serious), 6 Class II, 2 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of methotrexate and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

StartedClassCompanyReason
August 1, 2024Class IIIAmneal Pharmaceuticals, LLCPresence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
September 22, 2023Class IIIWest-Ward Columbus IncFailed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and …
December 6, 2021Class IIEdge Pharma, LLCLack of Assurance of Sterility
March 15, 2021Class IICardinal Health Inc.CGMP Deviations: Intermittent exposure to temperature excursion during storage.
March 19, 2020Class IIEdge Pharma, LLC not a listed makerLack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
June 12, 2019Class IIInfusion Options, Inc.Lack of Assurance of Sterility
March 18, 2015Class IMylan Institutional LLCPresence of Particulate Matter
May 20, 2013Class ISandoz IncorporatedPresence of Particulate Matter: Found during examination of retention samples.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the methotrexate label say about other medicines?

The methotrexate label names 24 other medicines in its interaction, contraindication or warning sections. The labels of 36 other medicines name methotrexate. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Aspirindrug interactionsOral antibiotics (including neomycin) Antifolate drugs (e.g., dapsone, pemetrexed, pyrimethamine and sulfonamides) Oral or intravenous penicillin or sulfonamide antibiotics Aspirin and other nonsteroidal anti-inflammatory drugs Highly protein-bound drugs (e.g., oral anticoagulants, phenytoin, salicylates …
Azathioprinedrug interactionsTherefore, patients receiving concomitant therapy with Rasuvo and other potential hepatotoxins (e.g., azathioprine, retinoids, and sulfasalazine) should be closely monitored for possible increased risk of hepatotoxicity.
Chloramphenicoldrug interactionsOral antibiotics such as tetracycline, chloramphenicol, and nonabsorbable broad spectrum antibiotics, may decrease intestinal absorption of methotrexate or interfere with the enterohepatic circulation by inhibiting bowel flora and suppressing metabolism of the drug by bacteria.
Cyclosporinewarnings and precautionsMalignancies malignancies can occur with methotrexate The risk of cutaneous malignancies is further increased when cyclosporine is administered to patients with psoriasis who received prior methotrexate.
Dapsonedrug interactionsOral antibiotics (including neomycin) Antifolate drugs (e.g., dapsone, pemetrexed, pyrimethamine and sulfonamides) Oral or intravenous penicillin or sulfonamide antibiotics Aspirin and other nonsteroidal anti-inflammatory drugs Highly protein-bound drugs (e.g., oral anticoagulants, phenytoin, salicylates …
Esomeprazoledrug interactionsCase reports and published population pharmacokinetic studies suggest that concomitant use of some PPIs, such as omeprazole, esomeprazole, and pantoprazole, with methotrexate (primarily at high dose), may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to …
Glucarpidasewarnings and precautions… the adverse drug reaction, and availability of alternative therapy [see Dosage and Administration ( 2.6 )]. glucarpidase in patients with toxic plasma methotrexate concentrations (> 1 micromole per liter) and delayed methotrexate clearance due to impaired renal function.
Hydroxychloroquinedrug interactionsCombined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine, or cytotoxic agents, has not been studied and may increase the incidence of adverse effects.
Leucovorindrug interactionsPreliminary animal and human studies have shown that small quantities of intravenously administered leucovorin enter the CSF primarily as 5-methyltetrahydrofolate and, in humans, remain 1 to 3 orders of magnitude lower than the usual methotrexate concentrations following intrathecal administration.
Mercaptopurinedrug interactionsMethotrexate increases the plasma levels of mercaptopurine.
Neomycindrug interactionsOral antibiotics (including neomycin) Antifolate drugs (e.g., dapsone, pemetrexed, pyrimethamine and sulfonamides) Oral or intravenous penicillin or sulfonamide antibiotics Aspirin and other nonsteroidal anti-inflammatory drugs Highly protein-bound drugs (e.g., oral anticoagulants, phenytoin, salicylates …
Nitrous oxidedrug interactions… Hepatotoxic products Proton pump inhibitors Weak acids (e.g., salicylates) Nephrotoxic products Probenecid 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 …
Omeprazoledrug interactionsCase reports and published population pharmacokinetic studies suggest that concomitant use of some PPIs, such as omeprazole, esomeprazole, and pantoprazole, with methotrexate (primarily at high dose), may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to …
Pantoprazoledrug interactionsCase reports and published population pharmacokinetic studies suggest that concomitant use of some PPIs, such as omeprazole, esomeprazole, and pantoprazole, with methotrexate (primarily at high dose), may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to …

Every other medicine the methotrexate label names

Medicine namedSectionWhat the label says
Pemetrexeddrug interactionsOral antibiotics (including neomycin) Antifolate drugs (e.g., dapsone, pemetrexed, pyrimethamine and sulfonamides) Oral or intravenous penicillin or sulfonamide antibiotics Aspirin and other …
Penicillaminedrug interactionsCombined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine, or cytotoxic agents, has not been studied and may increase the incidence of adverse effects.
Phenytoindrug interactions… anti-inflammatory drugs Highly protein-bound drugs (e.g., oral anticoagulants, phenytoin, salicylates, sulfonamides, sulfonylureas, and tetracyclines) Hepatotoxic products Proton pump inhibitors Weak …
Probeneciddrug interactions… pump inhibitors Weak acids (e.g., salicylates) Nephrotoxic products Probenecid Nitrous Oxide Coadministration of methotrexate with nitrous oxide anesthesia potentiates the effect of methotrexate on …
Pyrimethaminedrug interactionsOral antibiotics (including neomycin) Antifolate drugs (e.g., dapsone, pemetrexed, pyrimethamine and sulfonamides) Oral or intravenous penicillin or sulfonamide antibiotics Aspirin and other …
Ranitidinedrug interactions… PPIs, but was not observed when methotrexate was co-administered with ranitidine.
Sulfamethoxazole and trimethoprimdrug interactionsTrimethoprim/sulfamethoxazole has been reported rarely to increase bone marrow suppression in patients receiving methotrexate, probably by decreased tubular secretion and/or an additive antifolate …
Sulfasalazinedrug interactionsTherefore, patients receiving concomitant therapy with Rasuvo and other potential hepatotoxins (e.g., azathioprine, retinoids, and sulfasalazine) should be closely monitored for possible increased …
Tetracyclinedrug interactionsOral antibiotics such as tetracycline, chloramphenicol, and nonabsorbable broad spectrum antibiotics, may decrease intestinal absorption of methotrexate or interfere with the enterohepatic …
Theophyllinedrug interactionsMethotrexate may decrease the clearance of theophylline; theophylline levels should be monitored when used concurrently with Rasuvo.

Other labels that name methotrexate

Check methotrexate against other medicines

Source: FDA drug label (Methotrexate), Accord Healthcare Inc., effective May 27, 2026 (SPL set 874c7f43-a3be-4236-89cc-24c44e3c5813), via openFDA; the full label on DailyMed

What do FAERS reports show for methotrexate?

The FDA Adverse Event Reporting System holds 489,791 reports that list methotrexate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 37,720 are coded as a death and 133,303 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)93,149
  • Rheumatoid Arthritis (a use or a product term, not a reaction)42,800
  • Arthralgia (named in the label)40,827
  • Off Label Use (a use or a product term, not a reaction)40,061
  • Pain39,719
  • Fatigue (named in the label)33,049
  • Nausea (named in the label)28,999
  • Joint Swelling25,029

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as methotrexate?

9 other medicines are given the same way (oral) and in the same FDA class as methotrexate or labeled mainly for the same use (rheumatoid arthritis), the same class first. Rheumatoid arthritis lists all 46 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

MedicineShared indicationGeneric labelers (oral)Pharmacy costShortage
IndomethacinRheumatoid arthritis25 labelers$0.210 per capsule 75 mg capsuleNo current entry
HydroxychloroquineRheumatoid arthritis28 labelers$0.149 per tablet 200 mg tabletA presentation being discontinued
TofacitinibRheumatoid arthritis24 labelers$0.573 per tablet 5 mg tabletNo current entry
LeflunomideRheumatoid arthritis16 labelers$0.324 per tablet 10 mg tabletA presentation being discontinued
PenicillamineRheumatoid arthritis9 labelersn/aNo current entry
BaricitinibRheumatoid arthritisnone listed$92.54 per tablet 2 mg tabletNo current entry
FlurbiprofenRheumatoid arthritis3 labelers$3.17 per tablet 100 mg tabletNo current entry
UpadacitinibRheumatoid arthritisnone listed$229.31 per tablet 15 mg tabletNo current entry

Every medicine labeled for the same conditions as methotrexate

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

How does methotrexate compare with medicines for the same use?

11 side-by-side pages set methotrexate beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.

What next?

Alternatives to methotrexate
9 medicines for the same use
Other folate analog metabolic inhibitors
the pharmacologic class, with prices and generics
Methotrexate side effects
the label's list beside FAERS reports
Methotrexate shortage record
every presentation, company and date
Check an interaction
what two or more labels say about each other