Adalimumab and Methotrexate interaction

Adalimumab and Methotrexate: the Adalimumab prescribing label flag this combination with the strongest language, such as a contraindication, a boxed warning, or an instruction to avoid it.

Major

Do not combine without a prescriber's guidance. The label language below is the strongest FDA uses.

What the FDA labels say

From the Adalimumab label · effective 2026-01-12

Major

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

Boxed warningnames MethotrexateView label on DailyMed
Major

It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants [see Warnings and Precautions (5.2) ] .

Boxed warningby drug classView label on DailyMed
Moderate

Patients 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.

Warnings and precautionsnames MethotrexateView label on DailyMed
Minor

Methotrexate Adalimumab has been studied in rheumatoid arthritis (RA) patients taking concomitant methotrexate (MTX).

Drug interactionsnames MethotrexateView label on DailyMed

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Not medical advice. Interaction Checker quotes FDA label text and NIH fact sheets. Whether an interaction matters for you depends on doses, timing, kidney and liver function, and other conditions. Confirm with a pharmacist or prescriber.