Infliximab and Methotrexate interaction

Infliximab and Methotrexate: the Infliximab 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 Infliximab (Renflexis) label · effective 2026-08-28

Major

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

Boxed warningnames MethotrexateView label on DailyMed
Moderate

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.

Warnings and precautionsnames MethotrexateView label on DailyMed
Moderate

When treating patients, consideration of whether to use RENFLEXIS alone or in combination with other immunosuppressants such as azathioprine or 6-mercaptopurine should take into account a possibility that there is a higher risk of HSTCL with combination therapy versus an observed increased risk of immunogenicity and hypersensitivity reactions with infliximab…

Warnings and precautionsby drug classView label on DailyMed
Minor

Methotrexate and Other Concomitant Medications Specific drug interaction studies, including interactions with methotrexate (MTX), have not been conducted.

Drug interactionsnames MethotrexateView label on DailyMed
Minor

It is uncertain whether the occurrence of HSTCL is related to TNF blockers or TNF blockers in combination with these other immunosuppressants.

Warnings and precautionsby drug classView 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.