What the FDA labels say about taking them together
Bicalutamide and midazolam
Bicalutamide's FDA label of April 23, 2026 names midazolam in its drug interactions section; the midazolam labels PlainMeds reads (4) do not name bicalutamide. The bicalutamide label: “Clinical studies have shown that with co-administration of bicalutamide, mean midazolam (a CYP 3A4 substrate) levels may be increased 1.5-fold (for C max ) and 1.9-fold (for AUC).”
Check it at the source: the bicalutamide FDA label on DailyMed (effective April 23, 2026, Golden State Medical Supply, Inc.); the midazolam FDA label on DailyMed (effective January 1, 2024, Fresenius Kabi USA, LLC).
What does the bicalutamide label say about midazolam?
Bicalutamide label, drug interactionsClinical studies have shown that with co-administration of bicalutamide, mean midazolam (a CYP 3A4 substrate) levels may be increased 1.5-fold (for C max ) and 1.9-fold (for AUC).
Source: FDA drug label (Bicalutamide), NDA020498 (Ani Pharms), as published by Golden State Medical Supply, Inc., effective April 23, 2026 (SPL set 26e30155-a50b-df14-e063-6394a90a9be4), via openFDA; the full label on DailyMed
What does the midazolam label say about bicalutamide?
Midazolam's label (effective January 1, 2024) and its 3 other brand-application labels do not name bicalutamide 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
| Bicalutamide | Midazolam | |
|---|---|---|
| Labeled for | n/a | n/a |
| Boxed warning | No | Yes |
| Pharmacy cost (NADAC) | $0.404 per tablet 50 mg tablet | $0.233 per mL 2 mg/2 mL vial |
| 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