What the FDA labels say about taking them together
Bivalirudin and heparin
Bivalirudin's FDA label of September 30, 2019 names heparin in its drug interactions section; heparin's label does not name bivalirudin itself but warns about its class (anti-coagulants). 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 heparin FDA label on DailyMed (effective November 28, 2025, Fresenius Kabi USA, LLC).
What does the bivalirudin label say about heparin?
Bivalirudin label, drug interactionsDRUG 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.
Bivalirudin label, warnings and precautionsThrombosis in Patients with STEMI Undergoing PCI Acute stent thrombosis (AST) (less than 4 hours) has been observed at a greater frequency in bivalirudin treated patients (1.2%, 36/2889) compared to heparin treated patients (0.2%, 6/2911) with STEMI undergoing primary PCI.
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 heparin label say about bivalirudin?
Heparin's label does not name bivalirudin itself; it warns about its class (anti-coagulants):
Heparin label, warnings and precautionsAdrenal hemorrhage (with resultant acute adrenal insufficiency), ovarian hemorrhage, and retroperitoneal hemorrhage have occurred during anticoagulant therapy with heparin [see Adverse Reactions ( 6.1 )].
Heparin label, drug interactionsTo reduce the risk of bleeding, a reduction in the dose of antiplatelet agent or heparin is recommended. Other Interactions Digitalis, tetracyclines, nicotine or antihistamines may partially counteract the anticoagulant action of heparin sodium.
Source: FDA drug label (Heparin Sodium), Fresenius Kabi USA, LLC, effective November 28, 2025 (SPL set d55b4a63-0c04-4874-b74f-9e9b9e8b008c), 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
| Bivalirudin | Heparin | |
|---|---|---|
| Labeled for | n/a | Blood clots (DVT and PE), Atrial fibrillation |
| Boxed warning | No | No |
| Pharmacy cost (NADAC) | n/a | $1.18 per mL 5,000 unit/mL vial |
| Shortage now | No current entry | In shortage |
Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)
What next?
- Check more medicines together
- up to five at once