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What the FDA labels say about taking them together

Enzalutamide and midazolam

Enzalutamide's FDA label (Xtandi) of May 25, 2021 names midazolam in its drug interactions section; the midazolam labels PlainMeds reads (4) do not name enzalutamide. The enzalutamide label: “At steady-state, XTANDI reduced the plasma exposure to midazolam (CYP3A4 substrate), warfarin (CYP2C9 substrate), and omeprazole (CYP2C19 substrate).”

Check it at the source: the enzalutamide FDA label on DailyMed (effective July 28, 2026, Astellas Pharma US, Inc.); the midazolam FDA label on DailyMed (effective January 1, 2024, Fresenius Kabi USA, LLC).

What does the enzalutamide label say about midazolam?

Xtandi label (Astellas Pharma US, Inc., May 25, 2021), drug interactions

At steady-state, XTANDI reduced the plasma exposure to midazolam (CYP3A4 substrate), warfarin (CYP2C9 substrate), and omeprazole (CYP2C19 substrate).

Source: FDA drug label (Xtandi, NDA213674), Astellas Pharma US, Inc., effective May 25, 2021 (SPL set 381cd215-78c9-4208-8595-7ae7a279b236), via openFDA

Source: FDA drug label (Xtandi), Astellas Pharma US, Inc., effective July 28, 2026 (SPL set b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf), via openFDA; the full label on DailyMed

What does the midazolam label say about enzalutamide?

Midazolam's label (effective January 1, 2024) and its 3 other brand-application labels do not name enzalutamide in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Midazolam), Fresenius Kabi USA, LLC, effective January 1, 2024 (SPL set 1cc9ba6e-fa1b-405e-9de8-720c567b2a73), 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

0Enzalutamide generic labelers
22Midazolam generic labelers
EnzalutamideMidazolam
Labeled forProstate cancern/a
Boxed warningNoYes
Pharmacy cost (NADAC)n/a$0.233 per mL 2 mg/2 mL vial
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?