What the FDA labels say about taking them together
Itraconazole and midazolam
Itraconazole's FDA label of July 13, 2026 names midazolam in its boxed warning section, and midazolam's label names itraconazole too. 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 itraconazole FDA label on DailyMed (effective July 13, 2026, Janssen Pharmaceuticals, Inc.); the midazolam FDA label on DailyMed (effective January 1, 2024, Fresenius Kabi USA, LLC).
What does the itraconazole label say about midazolam?
Itraconazole label, boxed warningSome examples of drugs that are contraindicated for coadministration with SPORANOX ® Capsules are: methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor, finerenone, voclosporin.
Itraconazole label, drug interactionsAntipsychotics, Anxiolytics and Hypnotics Alprazolam Aripiprazole Buspirone Cariprazine Diazepam Haloperidol Midazolam (IV) Quetiapine Ramelteon Risperidone Suvorexant Monitor for adverse reactions.
Source: FDA drug label (Tolsura, NDA208901), Mayne Pharma Commercial LLC, effective April 23, 2025 (SPL set 306352d1-9d5a-49ad-b72d-893b99546861), via openFDA
Source: FDA drug label (SPORANOX), Janssen Pharmaceuticals, Inc., effective July 13, 2026 (SPL set a4d555fa-787c-40fb-bb7d-b0d4f7318fd0), via openFDA; the full label on DailyMed
What does the midazolam label say about itraconazole?
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. … 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
| Itraconazole | Midazolam | |
|---|---|---|
| Labeled for | Fungal infections | n/a |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | $0.910 per capsule 100 mg capsule | $0.233 per mL 2 mg/2 mL vial |
| Shortage now | A presentation being discontinued | 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