What the FDA labels say about taking them together
Golimumab and methotrexate
Golimumab's FDA label of September 9, 2025 names methotrexate in its boxed warning section; the methotrexate labels PlainMeds reads (4) do not name golimumab. The golimumab label: “Patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants such as corticosteroids or methotrexate may be at greater risk of infection.”
Check it at the source: the golimumab FDA label on DailyMed (effective September 9, 2025, Janssen Biotech, Inc.); the methotrexate FDA label on DailyMed (effective May 27, 2026, Accord Healthcare Inc.).
What does the golimumab label say about methotrexate?
Golimumab label, boxed warningMost patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Golimumab label, drug interactionsMethotrexate SIMPONI ARIA should be used with MTX for the treatment of RA [see Clinical Studies (14.1) ].
Golimumab label, warnings and precautionsPatients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants such as corticosteroids or methotrexate may be at greater risk of infection.
Simponi label (Janssen Biotech, Inc., October 29, 2025), drug interactionsFor the treatment of RA, SIMPONI should be used with methotrexate (MTX) [see Clinical Studies (14.1) ].
Source: FDA drug label (Simponi, BLA125289), Janssen Biotech, Inc., effective October 29, 2025 (SPL set f86cb4a7-c358-4136-ae57-b32bda9bba00), via openFDA
Source: FDA drug label (SIMPONI ARIA), Janssen Biotech, Inc., effective September 9, 2025 (SPL set 9e260a47-55af-4c92-8d88-a86ccc767fff), via openFDA; the full label on DailyMed
What does the methotrexate label say about golimumab?
Methotrexate's label (effective May 27, 2026) and its 3 other brand-application labels do not name golimumab 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
| Golimumab | Methotrexate | |
|---|---|---|
| Labeled for | Rheumatoid arthritis, Crohn's disease and ulcerative colitis | Rheumatoid arthritis, Psoriasis, Leukemia, lymphoma and myeloma, Breast cancer |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | $12,890.32 per mL 50 mg/0.5 mL pen injec | $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