What the FDA labels say about taking them together
Adalimumab and methotrexate
Adalimumab's FDA label of October 21, 2025 names methotrexate in its boxed warning section; the methotrexate labels PlainMeds reads (4) do not name adalimumab. The adalimumab label: “Patients 65 years of age and older, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants, may be at greater risk of infection.”
Check it at the source: the adalimumab FDA label on DailyMed (effective October 21, 2025); the methotrexate FDA label on DailyMed (effective May 27, 2026, Accord Healthcare Inc.).
What does the adalimumab label say about methotrexate?
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).
Adalimumab label, warnings and precautionsPatients 65 years of age and older, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection.
Source: FDA drug label (Humira, BLA125057), AbbVie Inc., effective December 23, 2025 (SPL set 608d4f0d-b19f-46d3-749a-7159aa5f933d), via openFDA
Source: FDA drug label (Adalimumab), Sandoz Inc, effective October 21, 2025 (SPL set 3468792f-63ef-4916-8ed1-8214f327d9dd), via openFDA; the full label on DailyMed
What does the methotrexate label say about adalimumab?
Methotrexate's label (effective May 27, 2026) and its 3 other brand-application labels do not name adalimumab in these sections. A label lists what its studies and reports found; it is not a complete list.
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
These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.
Both medicines on the record
| Adalimumab | Methotrexate | |
|---|---|---|
| Labeled for | Rheumatoid arthritis, Crohn's disease and ulcerative colitis, Psoriasis | Rheumatoid arthritis, Psoriasis, Leukemia, lymphoma and myeloma, Breast cancer |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | $1,587.82 per mL 40 mg/0.4 mL | $0.158 per tablet 2.5 mg tablet |
| Shortage now | No current entry | In shortage |
Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)
What next?
- Check more medicines together
- up to five at once