What the FDA labels say about taking them together
Ketoconazole and midazolam
Midazolam's FDA label of January 1, 2024 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name midazolam. The midazolam label: “Concomitant use of CYP3A4 inhibitors may result in prolonged sedation because of a decrease in plasma clearance of midazolam.”
Check it at the source: the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC); the midazolam FDA label on DailyMed (effective January 1, 2024, Fresenius Kabi USA, LLC).
What does the ketoconazole label say about midazolam?
Ketoconazole's label (effective January 28, 2026) does not name midazolam in these sections. A label lists what its studies and reports found; it is not a complete list.
Source: FDA drug label (ketoconazole), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set cad7c647-34a9-4e4e-83b3-8d78e58f588f), via openFDA; the full label on DailyMed
What does the midazolam label say about ketoconazole?
Midazolam label, drug interactionsOther Drug Interactions Caution is advised when midazolam is administered concomitantly with drugs that are known to inhibit the P450-3A4 enzyme system such as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole.
N/A label (Rafa Laboratories, Ltd., February 18, 2026), drug interactionsCytochrome P450-3A4 Inhibitors Caution is advised when Midazolam Injection is administered concomitantly with drugs that are known to inhibit the P450-3A4 enzyme system (e.g., cimetidine, erythromycin, diltiazem, verapamil, ketoconazole, and itraconazole).
Nayzilam label (UCB, Inc., January 19, 2023), drug interactions7.1 CYP3A4 Inhibitors Clinical Impact: Concomitant use of CYP3A4 inhibitors may result in prolonged sedation because of a decrease in plasma clearance of midazolam. … inhibitors. Examples: Moderate CYP3A4 inhibitors: erythromycin, diltiazem, verapamil Strong CYP3A4 inhibitors: ketoconazole, itraconazole, clarithromycin
Midazolam In Sodium Chloride label (WG Critical Care, LLC., July 31, 2025), drug interactionsConcomitant administration with drugs that are known to inhibit the P450-3A4 enzyme system, such as cimetidine (not ranitidine), erythromycin, diltiazem, verapamil, ketoconazole and itraconazole, may result in prolonged sedation due to a decrease in plasma clearance of midazolam.
Source: FDA drug label (N/A, NDA216359), Rafa Laboratories, Ltd., effective February 18, 2026 (SPL set d7362b4d-68a3-99a0-e053-2995a90a4f60), via openFDA
Source: FDA drug label (Nayzilam, NDA211321), UCB, Inc., effective January 19, 2023 (SPL set 2b29422e-54d5-4a49-8522-e9cf752368c3), via openFDA
Source: FDA drug label (Midazolam In Sodium Chloride, NDA211844), WG Critical Care, LLC., effective July 31, 2025 (SPL set f051776f-94c5-4e34-80ed-f45b9c36881e), via openFDA
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
| Ketoconazole | Midazolam | |
|---|---|---|
| Labeled for | Fungal infections | n/a |
| Boxed warning | No | Yes |
| Pharmacy cost (NADAC) | $0.249 per gram 2% cream | $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