Skip to main content

What the FDA labels say about taking them together

Etanercept and methotrexate

Etanercept's FDA label of May 11, 2026 names methotrexate in its boxed warning section; the methotrexate labels PlainMeds reads (4) do not name etanercept. The etanercept label: “Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants, may be at greater risk of infection.”

Check it at the source: the etanercept FDA label on DailyMed (effective May 11, 2026, Immunex Corporation); the methotrexate FDA label on DailyMed (effective May 27, 2026, Accord Healthcare Inc.).

What does the etanercept label say about methotrexate?

Etanercept label, boxed warning

Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Etanercept label, warnings and precautions

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.

Source: FDA drug label (ENBREL), Immunex Corporation, effective May 11, 2026 (SPL set a002b40c-097d-47a5-957f-7a7b1807af7f), via openFDA; the full label on DailyMed

What does the methotrexate label say about etanercept?

Methotrexate's label (effective May 27, 2026) and its 3 other brand-application labels do not name etanercept 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

0Etanercept generic labelers
29Methotrexate generic labelers
EtanerceptMethotrexate
Labeled forRheumatoid arthritis, PsoriasisRheumatoid arthritis, Psoriasis, Leukemia, lymphoma and myeloma, Breast cancer
Boxed warningYesYes
Pharmacy cost (NADAC)$2,084.14 per mL 25 mg/0.5 mL syringe$0.158 per tablet 2.5 mg tablet
Shortage nowNo current entryIn shortage

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?