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What the FDA labels say about taking them together

Bivalirudin and warfarin

Bivalirudin's FDA label of September 30, 2019 names warfarin in its drug interactions section, and warfarin's label names bivalirudin too. The bivalirudin label: “DRUG INTERACTIONS In clinical trials in patients undergoing PCI, co-administration of bivalirudin with heparin, warfarin, thrombolytics, or GPIs was associated with increased risks of major bleeding events compared to …”

Check it at the source: the bivalirudin FDA label on DailyMed (effective September 30, 2019, Sandoz Inc); the warfarin FDA label on DailyMed (effective May 29, 2026, Amneal Pharmaceuticals LLC).

What does the bivalirudin label say about warfarin?

Bivalirudin label, drug interactions

DRUG INTERACTIONS In clinical trials in patients undergoing PCI/ percutaneous transluminal coronary angioplasty (PTCA), coadministration of bivalirudin with heparin, warfarin, thrombolytics, or GPIs was associated with increased risks of major bleeding events compared to patients not receiving these concomitant medications.

Source: FDA drug label (Bivalirudin, NDA211215), MAIA Pharmaceuticals, Inc., effective May 27, 2024 (SPL set c727199d-f4cd-4658-8fdf-568590beface), via openFDA

Source: FDA drug label (bivalirudin), Sandoz Inc, effective September 30, 2019 (SPL set ce56f806-7845-429d-a1ce-c2dbf79b22eb), via openFDA; the full label on DailyMed

What does the warfarin label say about bivalirudin?

Warfarin label, drug interactions

Drug Class: Anticoagulants; Specific Drugs: argatroban, dabigatran, bivalirudin, desirudin, heparin, lepirudin

Source: FDA drug label (Warfarin Sodium), Amneal Pharmaceuticals LLC, effective May 29, 2026 (SPL set 558b7a0d-5490-4c1b-802e-3ab3f1efe760), 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

9Bivalirudin generic labelers
19Warfarin generic labelers
BivalirudinWarfarin
Labeled forn/aBlood clots (DVT and PE), Atrial fibrillation
Boxed warningNoYes
Pharmacy cost (NADAC)n/a$0.093 per tablet 2 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?