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What the FDA labels say about taking them together

Bedaquiline and rifabutin

Bedaquiline's FDA label of October 17, 2025 names rifabutin in its warnings and precautions section, and rifabutin's label names bedaquiline too. The rifabutin label: “Avoid bedaquiline co-administration with rifabutin due to the adverse reactions associated with increased bedaquiline metabolite concentrations.”

Check it at the source: the bedaquiline FDA label on DailyMed (effective October 17, 2025, Janssen Products, LP); the rifabutin FDA label on DailyMed (effective September 1, 2026, REMEDYREPACK INC.).

What does the bedaquiline label say about rifabutin?

Bedaquiline label, warnings and precautions

Avoid coadministration of SIRTURO with moderate or strong CYP3A4 inducers, such as efavirenz and rifamycins (i.e., rifampin, rifapentine and rifabutin) [see Drug Interactions (7.1) ].

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 rifabutin label say about bedaquiline?

Rifabutin label, drug interactions

Co-administered drug: Bedaquiline; Dosing regimen of co-administered drug: 400 mg daily on day 1 and day 29; Dosing regimen of rifabutin: 300 mg daily; Study population (n): Healthy subjects (17); Effect on rifabutin: ND; Effect on co-administered drug: No change in bedaquiline pharmacokinetics. 1.4-fold ↑ in M2 and approximately 3.0-fold ↑ in M3 metabolites of bedaquiline.; Recommendation: Avoid bedaquiline co-administration with rifabutin due to the adverse reactions associated with increased bedaquiline metabolite concentrations.

Source: FDA drug label (Rifabutin), NDA050689 (Pfizer), as published by REMEDYREPACK INC., effective September 1, 2026 (SPL set 25a60937-cbbe-4a50-994f-2ce15203f589), 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
4Rifabutin generic labelers
BedaquilineRifabutin
Labeled forn/an/a
Boxed warningYesNo
Pharmacy cost (NADAC)n/a$8.14 per capsule 150 mg capsule
Shortage nowNo current entryNo current entry

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

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