Skip to main content

What the FDA labels say about taking them together

Dabigatran and pretomanid

Pretomanid's FDA label of November 15, 2024 names dabigatran in its drug interactions section; the dabigatran labels PlainMeds reads (2) do not name pretomanid. The pretomanid label: “Therefore, it cannot be excluded that co-administration of pretomanid with sensitive OATP1B3 substrates (e.g., valsartan, statins), BCRP substrates and P-gp substrates may increase their exposure.”

Check it at the source: the dabigatran FDA label on DailyMed (effective June 25, 2025, Boehringer Ingelheim Pharmaceuticals Inc.); the pretomanid FDA label on DailyMed (effective November 15, 2024, Viatris Specialty LLC).

What does the dabigatran label say about pretomanid?

Dabigatran's label (effective June 25, 2025) and its 1 other brand-application label do 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 (Pradaxa), Boehringer Ingelheim Pharmaceuticals Inc., effective June 25, 2025 (SPL set ba74e3cd-b06f-4145-b284-5fd6b84ff3c9), via openFDA; the full label on DailyMed

What does the pretomanid label say about dabigatran?

Pretomanid label, drug interactions

Therefore, it cannot be excluded that co-administration of pretomanid with sensitive OATP1B3 substrates (e.g., valsartan, statins), BCRP substrates (e.g., rosuvastatin, prazosin, glyburide, sulfasalazine) and P-gp substrates (e.g., digoxin, dabigatran etexilate, verapamil) may increase their exposure.

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

16Dabigatran generic labelers
0Pretomanid generic labelers
DabigatranPretomanid
Labeled forAtrial fibrillation, Blood clots (DVT and PE), Stroke preventionn/a
Boxed warningYesNo
Pharmacy cost (NADAC)$0.795 per capsule 150 mg capsulen/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?