What the FDA labels say about taking them together
Itraconazole and naldemedine
Naldemedine's FDA label of July 25, 2025 names itraconazole in its drug interactions section; the itraconazole labels PlainMeds reads (2) do not name naldemedine. The naldemedine label: “Moderate and Strong CYP3A Inhibitors Clinical Impact Increase in plasma naldemedine concentrations Intervention Monitor for potential naldemedine-related adverse reactions.”
Check it at the source: the itraconazole FDA label on DailyMed (effective July 13, 2026, Janssen Pharmaceuticals, Inc.); the naldemedine FDA label on DailyMed (effective July 25, 2025, BioDelivery Sciences International Inc).
What does the itraconazole label say about naldemedine?
Itraconazole's label (effective July 13, 2026) and its 1 other brand-application label do not name naldemedine in these sections. A label lists what its studies and reports found; it is not a complete list.
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 naldemedine label say about itraconazole?
Naldemedine label, drug interactionsModerate (e.g., fluconazole, atazanavir, aprepitant, diltiazem, erythromycin) and Strong (e.g., itraconazole, ketoconazole, clarithromycin, ritonavir, saquinavir) CYP3A Inhibitors Clinical Impact Increase in plasma naldemedine concentrations [see Clinical Pharmacology (12.3) ] Intervention Monitor for potential naldemedine-related adverse reactions [see Adverse Reactions (6.1) ].
Source: FDA drug label (SYMPROIC), NDA208854 (Bdsi), as published by BioDelivery Sciences International Inc, effective July 25, 2025 (SPL set b1a1256c-a1eb-4abe-ab1e-30e4711afd16), 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 | Naldemedine | |
|---|---|---|
| Labeled for | Fungal infections | n/a |
| Boxed warning | Yes | No |
| Pharmacy cost (NADAC) | $0.910 per capsule 100 mg capsule | $16.26 per tablet 0.2 mg tablet |
| Shortage now | A presentation being discontinued | No current entry |
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