Skip to main content

What the FDA labels say about taking them together

Bedaquiline and pretomanid

Pretomanid's FDA label of November 15, 2024 names bedaquiline in its contraindications section; the bedaquiline label PlainMeds reads does not name pretomanid. The pretomanid label: “Myelosuppression was reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid. Monitor complete blood counts.”

Check it at the source: the bedaquiline FDA label on DailyMed (effective October 17, 2025, Janssen Products, LP); the pretomanid FDA label on DailyMed (effective November 15, 2024, Viatris Specialty LLC).

What does the bedaquiline label say about pretomanid?

Bedaquiline's label (effective October 17, 2025) does not name pretomanid 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 pretomanid label say about bedaquiline?

Pretomanid label, contraindications

CONTRAINDICATIONS Pretomanid Tablets used in the combination regimen with bedaquiline and linezolid are contraindicated in patients for whom bedaquiline and/or linezolid are contraindicated. Refer to the bedaquiline and linezolid prescribing information.

Pretomanid label, drug interactions

Avoid co-administration of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid with rifampin, efavirenz, or other strong or moderate CYP3A4 inducers.

Pretomanid label, warnings and precautions

Myelosuppression was reported with the use of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid. Monitor complete blood counts.

Source: FDA drug label (Pretomanid), NDA212862 (Mylan Ireland Ltd), as published by Viatris Specialty LLC, effective November 15, 2024 (SPL set f1906fc9-cb3c-4e13-8a4a-da76100c1bf3), 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
0Pretomanid generic labelers
BedaquilinePretomanid
Labeled forn/an/a
Boxed warningYesNo
Pharmacy cost (NADAC)n/an/a
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?