What the FDA labels say about taking them together
Bedaquiline and levofloxacin
Bedaquiline's FDA label of October 17, 2025 names levofloxacin in its warnings and precautions section; the levofloxacin label PlainMeds reads does not name bedaquiline. The bedaquiline label: “In Study 4, where SIRTURO was administered with the QTc prolonging drugs clofazimine and levofloxacin, 5% of patients in the 40-week SIRTURO treatment group experienced a QTc ≥500 ms and 43% of patients experienced an …”
Check it at the source: the bedaquiline FDA label on DailyMed (effective October 17, 2025, Janssen Products, LP); the levofloxacin FDA label on DailyMed (effective July 10, 2024, Lupin Pharmaceuticals, Inc.).
What does the bedaquiline label say about levofloxacin?
Bedaquiline label, warnings and precautionsIn Study 4, where SIRTURO was administered with the QTc prolonging drugs clofazimine and levofloxacin, 5% of patients in the 40-week SIRTURO treatment group experienced a QTc ≥500 ms and 43% of patients experienced an increase in QTc ≥60 ms over baseline.
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 levofloxacin label say about bedaquiline?
Levofloxacin's label (effective July 10, 2024) does not name bedaquiline in these sections. A label lists what its studies and reports found; it is not a complete list.
Source: FDA drug label (Levofloxacin), Lupin Pharmaceuticals, Inc., effective July 10, 2024 (SPL set 4be13bd5-0c39-43c3-9232-b1226ccd4dbc), 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 | Levofloxacin | |
|---|---|---|
| Labeled for | n/a | Bacterial infections, Urinary tract infections |
| Boxed warning | Yes | Yes |
| Pharmacy cost (NADAC) | n/a | $0.259 per tablet 750 mg tablet |
| Shortage now | No current entry | 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