What the FDA labels say about taking them together

Bedaquiline and clofazimine

Bedaquiline's FDA label of October 17, 2025 names clofazimine in its drug interactions section, and clofazimine's label names bedaquiline too. The clofazimine label: “Concomitant use with other QT prolonging drugs or bedaquiline may cause additive QT prolongation.”

Check it at the source: the bedaquiline FDA label on DailyMed (effective October 17, 2025, Janssen Products, LP); the clofazimine FDA label on DailyMed (effective August 17, 2026, Novartis Pharmaceuticals Corporation).

What does the bedaquiline label say about clofazimine?

Bedaquiline label, drug interactions
In Study 3, concurrent use of clofazimine with SIRTURO resulted in QTc prolongation: mean increases in QTc were larger in the 17 adult patients who were taking clofazimine with bedaquiline at Week 24 (mean change from Day-1 of 32 ms) than in patients who were not taking clofazimine with bedaquiline at Week 24 (mean change from Day-1 of 12 ms).

Bedaquiline label, warnings and precautions
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 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 clofazimine label say about bedaquiline?

Clofazimine label, drug interactions
Drugs that Prolong QT Interval QT prolongation and Torsade de Pointes have been reported in patients receiving LAMPRENE in combination with QT prolonging medications, such as bedaquiline.

Clofazimine label, warnings and precautions
Concomitant use with other QT prolonging drugs or bedaquiline may cause additive QT prolongation.

Source: FDA drug label (Lamprene), Novartis Pharmaceuticals Corporation, effective August 17, 2026 (SPL set 2e07448f-f888-4747-80ab-570c1b621250), 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

0Bedaquiline generic labelers

0Clofazimine generic labelers

	Bedaquiline	Clofazimine
Labeled for	n/a	n/a
Boxed warning	Yes	No
Pharmacy cost (NADAC)	n/a	n/a
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?

Bedaquiline: the full record
Clofazimine: the full record
Check more medicines together: up to five at once