Two medicines, side by side
Methotrexate vs tofacitinib
Methotrexate and tofacitinib are both labeled for rheumatoid arthritis. Drugs@FDA records approvals of methotrexate since 1953 and of tofacitinib since 2012. Pharmacies paid $0.158 per methotrexate 2.5 mg tablet and $0.573 per tofacitinib 5 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Methotrexate's other strengths are brand-only: $21.76 per mL (Xatmep 2.5 mg/mL oral solution). In FDA's classes, methotrexate is a folate analog metabolic inhibitor and tofacitinib a janus kinase inhibitor.
Check it at the source: the methotrexate FDA label on DailyMed (effective May 27, 2026); the tofacitinib FDA label on DailyMed (effective July 13, 2026).
Highlights of the methotrexate record
Methotrexate (Rasuvo) · label of May 27, 2026
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) ].
Used for
From the label: indicationsMethotrexate 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 […]
On the market
- Earliest approval on file
- December 7, 1953
- Generic labelers
- 29 labelers
- Pharmacy cost
- $0.158 per tablet
Supply and safety
- Shortage
- In shortage
- Recalls
- 8
Highlights of the tofacitinib record
Tofacitinib (Xeljanz) · label of July 13, 2026
SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, and THROMBOSIS See full prescribing information for complete boxed warning.
Increased risk of serious bacterial, fungal, viral, and opportunistic infections, including tuberculosis (TB), leading to hospitalization or death.
Used for
From the label: indicationsXELJANZ (tablets and oral solution) and XELJANZ XR (extended-release tablets) are Janus kinase (JAK) inhibitors. XELJANZ tablets and XELJANZ XR are indicated for the treatment of adult patients with: • Moderately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. […]
On the market
- Earliest approval on file
- November 6, 2012
- Generic labelers
- 24 labelers
- Pharmacy cost
- $0.573 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Methotrexate label of May 27, 2026, Tofacitinib label of July 13, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do methotrexate and tofacitinib differ on the record?
In FDA's classes, methotrexate is a folate analog metabolic inhibitor and tofacitinib a janus kinase inhibitor.
How each works, in its label's words: Methotrexate, “Methotrexate inhibits dihydrofolic acid reductase.”; Tofacitinib, “Tofacitinib is a Janus kinase (JAK) inhibitor.”
Half-life, in each label's words: Methotrexate, “Elimination The elimination half-life of methotrexate is approximately 3 to 10 hours.”; Tofacitinib, “12.3 Pharmacokinetics Following oral administration of XELJANZ (tablets and oral solution), peak plasma concentrations …”
Both labels carry a boxed warning; the records quote them.
Generics: methotrexate since 1979; tofacitinib since 2021 (Drugs@FDA).
| Methotrexate | Tofacitinib | |
|---|---|---|
| Labeled for | Rheumatoid arthritis, Psoriasis, Leukemia, lymphoma and myeloma, Breast cancer | Rheumatoid arthritis, Crohn's disease and ulcerative colitis |
| Pharmacologic class | Folate Analog Metabolic Inhibitor | Janus Kinase Inhibitor |
| How it works (label) | 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. | Tofacitinib is a Janus kinase (JAK) inhibitor. |
| Half-life (label) | Elimination The elimination half-life of methotrexate is approximately 3 to 10 hours. | 12.3 Pharmacokinetics Following oral administration of XELJANZ (tablets and oral solution), peak plasma concentrations were reached within 0.5 hour - 1 hour, elimination half-life was about 3 hours and a … |
| Earliest approval on file (Drugs@FDA) | December 7, 1953 | November 6, 2012 |
| First generic approved | September 5, 1979 | June 1, 2021 |
| Generic labelers (NDC) | 29 labelers | 24 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.158 per tablet (Methotrexate 2.5 mg tablet) | $0.573 per tablet (Tofacitinib 5 mg tablet) |
| 12-month price change | -4% | n/a |
| Boxed warning | Yes | Yes |
| Shortage now | In shortage | No current entry |
| Recalls recorded | 8 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 489,791 | 186,746 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Tofacitinib label, boxed warningMost patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Tofacitinib label, warnings and precautionsSome patients have presented with disseminated rather than localized disease, and were often taking concomitant immunomodulating agents such as methotrexate or corticosteroids.
Source: FDA drug labels via openFDA
What do the labels say about using others of their kind?
Methotrexate label, drug 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, sulfonamides, sulfonylureas, and tetracyclines) Hepatotoxic products Proton pump inhibitors Weak acids (e.g. …
Source: FDA drug labels via openFDA
What next?
- Alternatives to methotrexate
- every medicine labeled for the same conditions