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What the FDA labels say about taking them together

Dabigatran and darunavir

Darunavir's FDA label of August 29, 2025 names dabigatran in its drug interactions section; the dabigatran labels PlainMeds reads (2) do not name darunavir. The darunavir label: “Refer to the dabigatran etexilate or edoxaban prescribing information for recommendations regarding co-administration. The specific recommendations are based on indication, renal function, and effect of the …”

Check it at the source: the dabigatran FDA label on DailyMed (effective June 25, 2025, Boehringer Ingelheim Pharmaceuticals Inc.); the darunavir FDA label on DailyMed (effective August 29, 2025, Janssen Products LP).

What does the dabigatran label say about darunavir?

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

Darunavir label, drug interactions

Concomitant Drug Class Drug Name Examples: dabigatran etexilate edoxaban; Effect on Concentration of Darunavir Or Concomitant Drug: ↑ dabigatran ↑ edoxaban; Clinical Comment: Refer to the dabigatran etexilate or edoxaban prescribing information for recommendations regarding co-administration. The specific recommendations are based on indication, renal function, and effect of the co-administered P-gp inhibitors on the concentration of dabigatran or edoxaban. Clinical monitoring is recommended when a DOAC not affected by CYP3A4 but transported by P-gp, including dabigatran etexilate and edoxaban, is co-administered with PREZISTA/ritonavir.

Source: FDA drug label (PREZISTA), Janssen Products LP, effective August 29, 2025 (SPL set 814301f9-c990-46a5-b481-2879a521a16f), 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
13Darunavir generic labelers
DabigatranDarunavir
Labeled forAtrial fibrillation, Blood clots (DVT and PE), Stroke preventionHIV
Boxed warningYesNo
Pharmacy cost (NADAC)$0.795 per capsule 150 mg capsule$1.16 per tablet 600 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?