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What the FDA labels say about taking them together

Dabigatran and primaquine

Primaquine's FDA label of February 11, 2026 names dabigatran in its drug interactions section; the dabigatran labels PlainMeds reads (2) do not name primaquine. The primaquine label: “P-gp Substrates Refer to the Prescribing Information for a P-gp substrate where minimal concentration changes may lead to serious adverse reactions for the recommended dosage modification and/or monitoring.”

Check it at the source: the dabigatran FDA label on DailyMed (effective June 25, 2025, Boehringer Ingelheim Pharmaceuticals Inc.); the primaquine FDA label on DailyMed (effective February 11, 2026, Sanofi-Aventis U.S. LLC).

What does the dabigatran label say about primaquine?

Dabigatran's label (effective June 25, 2025) and its 1 other brand-application label do not name primaquine 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 primaquine label say about dabigatran?

Primaquine label, drug interactions

P-gp Substrates Refer to the Prescribing Information for a P-gp substrate where minimal concentration changes may lead to serious adverse reactions (e.g., digoxin and dabigatran) for the recommended dosage modification and/or monitoring.

Source: FDA drug label (Primaquine Phosphate), Sanofi-Aventis U.S. LLC, effective February 11, 2026 (SPL set 1bfbf4ae-81b8-4160-a00d-6322aadd4b59), 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
4Primaquine generic labelers
DabigatranPrimaquine
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?