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What the FDA labels say about taking them together

Dabigatran and itraconazole

Itraconazole's FDA label of July 13, 2026 names dabigatran in its drug interactions section; the dabigatran labels PlainMeds reads (2) do not name itraconazole. The itraconazole label: “Apixaban Rivaroxaban Vorapaxar Not recommended during and 2 weeks after TOLSURA treatment. Cilostazol Dabigatran Warfarin Monitor for adverse reactions.”

Check it at the source: the dabigatran FDA label on DailyMed (effective June 25, 2025, Boehringer Ingelheim Pharmaceuticals Inc.); the itraconazole FDA label on DailyMed (effective July 13, 2026, Janssen Pharmaceuticals, Inc.).

What does the dabigatran label say about itraconazole?

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

Itraconazole label, drug interactions

Apixaban Rivaroxaban Vorapaxar Not recommended during and 2 weeks after SPORANOX ® treatment. Cilostazol Dabigatran Warfarin Monitor for adverse reactions.

Source: FDA drug label (Tolsura, NDA208901), Mayne Pharma Commercial LLC, effective April 23, 2025 (SPL set 306352d1-9d5a-49ad-b72d-893b99546861), via openFDA

Source: FDA drug label (SPORANOX), Janssen Pharmaceuticals, Inc., effective July 13, 2026 (SPL set a4d555fa-787c-40fb-bb7d-b0d4f7318fd0), 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
11Itraconazole generic labelers
DabigatranItraconazole
Labeled forAtrial fibrillation, Blood clots (DVT and PE), Stroke preventionFungal infections
Boxed warningYesYes
Pharmacy cost (NADAC)$0.795 per capsule 150 mg capsule$0.910 per capsule 100 mg capsule
Shortage nowNo current entryA presentation being discontinued

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

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