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What the FDA labels say about taking them together

Bedaquiline and isoniazid

Bedaquiline's FDA label of October 17, 2025 names isoniazid in its drug interactions section; the isoniazid label PlainMeds reads does not name bedaquiline. The bedaquiline label: “No dose adjustment of isoniazid or pyrazinamide is required during coadministration with SIRTURO.”

Check it at the source: the bedaquiline FDA label on DailyMed (effective October 17, 2025, Janssen Products, LP); the isoniazid FDA label on DailyMed (effective July 8, 2025, OMNIVIUM PHARMACEUTICALS LLC.).

What does the bedaquiline label say about isoniazid?

Bedaquiline label, drug interactions

No dose adjustment of isoniazid or pyrazinamide is required during coadministration with SIRTURO.

Bedaquiline label, warnings and precautions

Bedaquiline must only be used in an appropriate combination regimen for the treatment of pulmonary TB due to M. tuberculosis resistant to at least rifampin and isoniazid, to reduce the risk of development of resistance to bedaquiline [see Indications and Usage (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 isoniazid label say about bedaquiline?

Isoniazid's label (effective July 8, 2025) 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 (isoniazid), OMNIVIUM PHARMACEUTICALS LLC., effective July 8, 2025 (SPL set 35400f1d-fd25-4bfa-a382-ac390e21bf2e), 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
14Isoniazid generic labelers
BedaquilineIsoniazid
Labeled forn/an/a
Boxed warningYesYes
Pharmacy cost (NADAC)n/a$3.40 per tablet 300 mg tablet
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)

What next?