What the FDA labels say about taking them together
Bedaquiline and itraconazole
Itraconazole's FDA label of July 13, 2026 names bedaquiline in its drug interactions section; the bedaquiline label PlainMeds reads does not name itraconazole. The itraconazole label: “Concomitant TOLSURA not recommended for more than 2 weeks at any time during bedaquiline treatment.”
Check it at the source: the bedaquiline FDA label on DailyMed (effective October 17, 2025, Janssen Products, LP); the itraconazole FDA label on DailyMed (effective July 13, 2026, Janssen Pharmaceuticals, Inc.).
What does the bedaquiline label say about itraconazole?
Bedaquiline's label (effective October 17, 2025) does not name itraconazole in these sections. A label lists what its studies and reports found; it is not a complete list.
Source: FDA drug label (SIRTURO), Janssen Products, LP, effective October 17, 2025 (SPL set 1534c9ae-4948-4cf4-9f66-222a99db6d0e), via openFDA; the full label on DailyMed
What does the itraconazole label say about bedaquiline?
Itraconazole label, drug interactionsConcomitant SPORANOX ® not recommended for more than 2 weeks at any time during bedaquiline treatment.
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
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
| Bedaquiline | Itraconazole | |
|---|---|---|
| Labeled for | n/a | Fungal infections |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | n/a | $0.910 per capsule 100 mg capsule |
| Shortage now | No current entry | A presentation being discontinued |
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