What the FDA labels say about taking them together
Infliximab and methotrexate
Infliximab's FDA label of August 28, 2026 names methotrexate in its boxed warning section; the methotrexate labels PlainMeds reads (4) do not name infliximab. The infliximab label: “Patients greater than 65 years of age, patients with comorbid 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 infliximab FDA label on DailyMed (effective August 28, 2026); the methotrexate FDA label on DailyMed (effective May 27, 2026, Accord Healthcare Inc.).
What does the infliximab label say about methotrexate?
Infliximab label, boxed warningMost patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Infliximab label, drug interactionsSpecific drug interaction studies, including interactions with methotrexate (MTX), have not been conducted.
Infliximab 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.
Source: FDA drug label (Inflectra, BLA125544), Pfizer Laboratories Div Pfizer Inc, effective July 28, 2026 (SPL set 37eaca10-d812-48bc-8b8e-b836bfa9968f), via openFDA
Source: FDA drug label (Renflexis), Organon LLC, effective August 28, 2026 (SPL set dbf738c4-3fac-4422-a9d8-51d9c83a8789), via openFDA; the full label on DailyMed
What does the methotrexate label say about infliximab?
Methotrexate's label (effective May 27, 2026) and its 3 other brand-application labels do not name infliximab 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
| Infliximab | 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) | n/a | $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