Two medicines, side by side
Methotrexate vs adalimumab
Methotrexate and adalimumab are both labeled for rheumatoid arthritis and psoriasis. Drugs@FDA records approvals of methotrexate since 1953 and of adalimumab since 2002. Pharmacies paid $0.158 per methotrexate 2.5 mg tablet and $1,587.82 per mL (Adalimumab-adaz(cf) pen 40 mg/0.4 mL) (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 adalimumab a tumor necrosis factor blocker.
Check it at the source: the methotrexate FDA label on DailyMed (effective May 27, 2026); the adalimumab FDA label on DailyMed (effective October 21, 2025).
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 adalimumab record
Adalimumab (Humira) · label of October 21, 2025
SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including Adalimumab-adaz, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue Adalimumab-adaz if a patient develops a serious infection or sepsis.
Used for
From the label: indicationsAdalimumab-adaz is a tumor necrosis factor (TNF)-blocker indicated for: • Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. […]
On the market
- Earliest approval on file
- December 31, 2002
- Generic labelers
- none listed
- Pharmacy cost
- $1,587.82 per mL
Supply and safety
- Shortage
- No current entry
- Recalls
- 1
Source: FDA drug labels via openFDA (Methotrexate label of May 27, 2026, Adalimumab label of October 21, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do methotrexate and adalimumab differ on the record?
In FDA's classes, methotrexate is a folate analog metabolic inhibitor and adalimumab a tumor necrosis factor blocker.
How each works, in its label's words: Methotrexate, “Methotrexate inhibits dihydrofolic acid reductase.”; Adalimumab, “Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors.”
Half-life, in each label's words: Methotrexate, “Elimination The elimination half-life of methotrexate is approximately 3 to 10 hours.”; Adalimumab, “The mean terminal half-life was approximately 2 weeks, ranging from 10 to 20 days across studies.”
Both labels carry a boxed warning; the records quote them.
Generics: methotrexate since 1979; adalimumab none approved (Drugs@FDA).
| Methotrexate | Adalimumab | |
|---|---|---|
| Labeled for | Rheumatoid arthritis, Psoriasis, Leukemia, lymphoma and myeloma, Breast cancer | Rheumatoid arthritis, Crohn's disease and ulcerative colitis, Psoriasis |
| Pharmacologic class | Folate Analog Metabolic Inhibitor | Tumor Necrosis Factor Blocker |
| 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. | Adalimumab products bind specifically to TNF-alpha and block its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab products also lyse surface TNF expressing cells in vitro in the presence of complement. |
| Half-life (label) | Elimination The elimination half-life of methotrexate is approximately 3 to 10 hours. | The mean terminal half-life was approximately 2 weeks, ranging from 10 to 20 days across studies. |
| Earliest approval on file (Drugs@FDA) | December 7, 1953 | December 31, 2002 |
| First generic approved | September 5, 1979 | none |
| Generic labelers (NDC) | 29 labelers | none listed |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.158 per tablet (Methotrexate 2.5 mg tablet) | $1,587.82 per mL (Adalimumab-adaz(cf) pen 40 mg/0.4 mL) |
| 12-month price change | -4% | -0.3% |
| Boxed warning | Yes | Yes |
| Shortage now | In shortage | No current entry |
| Recalls recorded | 8 | 1 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 489,791 | 712,308 |
| 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?
Adalimumab label, boxed warningMost patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Adalimumab label, drug interactionsAdalimumab has been studied in rheumatoid arthritis (RA) patients taking concomitant methotrexate (MTX).
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