Two medicines, side by side
Warfarin vs dabigatran
Warfarin and dabigatran are both labeled for atrial fibrillation and blood clots (DVT and PE). Drugs@FDA records approvals of warfarin since 1954 and of dabigatran since 2010. Pharmacies paid $0.093 per warfarin sodium 2 mg tablet and $0.795 per dabigatran etexilate 150 mg capsule (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, warfarin is a vitamin k antagonist and dabigatran a direct thrombin inhibitor.
Check it at the source: the warfarin FDA label on DailyMed (effective May 29, 2026); the dabigatran FDA label on DailyMed (effective June 25, 2025).
Highlights of the warfarin record
Warfarin (Coumadin) · label of May 29, 2026
BLEEDING RISK Warfarin sodium can cause major or fatal bleeding [see Warnings and Precautions (5.1) ]. Perform regular monitoring of INR in all treated patients [see Dosage and Administration (2.1) ]. Drugs, dietary changes, and other factors affect INR levels achieved with warfarin sodium therapy [see Drug Interactions (7) ]. Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding [see Patient Counseling Information (17) ].
Used for
From the label: indicationsWarfarin sodium tablets are indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement. […]
On the market
- Earliest approval on file
- June 8, 1954
- Generic labelers
- 19 labelers
- Pharmacy cost
- $0.093 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 7
Highlights of the dabigatran record
Dabigatran (Pradaxa) · label of June 25, 2025
(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS: Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events.
Used for
From the label: indicationsPRADAXA Capsules is a direct thrombin inhibitor indicated: To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1 ) For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days ( 1.2 ) To reduce the risk of recurrence of DVT and PE in adult patients who have […]
On the market
- Earliest approval on file
- October 19, 2010
- Generic labelers
- 16 labelers
- Pharmacy cost
- $0.795 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 9
Source: FDA drug labels via openFDA (Warfarin label of May 29, 2026, Dabigatran label of June 25, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do warfarin and dabigatran differ on the record?
In FDA's classes, warfarin is a vitamin k antagonist and dabigatran a direct thrombin inhibitor.
How each works, in its label's words: Warfarin, “Warfarin acts by inhibiting the synthesis of vitamin K-dependent clotting factors, which include Factors II, VII, IX, and X, and the anticoagulant proteins C and S.”; Dabigatran, “Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors.”
Half-life, in each label's words: Warfarin, “Excretion The terminal half-life of warfarin after a single dose is approximately 1 week; …”; Dabigatran, “The half-life of dabigatran in healthy adult subjects is 12 to 17 hours.”
Both labels carry a boxed warning; the records quote them.
Generics: warfarin since 1997; dabigatran since 2020 (Drugs@FDA).
| Warfarin | Dabigatran | |
|---|---|---|
| Labeled for | Blood clots (DVT and PE), Atrial fibrillation | Atrial fibrillation, Blood clots (DVT and PE), Stroke prevention |
| Pharmacologic class | Vitamin K Antagonist | Direct Thrombin Inhibitor |
| How it works (label) | Warfarin acts by inhibiting the synthesis of vitamin K-dependent clotting factors, which include Factors II, VII, IX, and X, and the anticoagulant proteins C and S. | Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors. |
| Half-life (label) | Excretion The terminal half-life of warfarin after a single dose is approximately 1 week; however, the effective half-life ranges from 20 to 60 hours, with a mean of about 40 hours. | The half-life of dabigatran in healthy adult subjects is 12 to 17 hours. |
| Earliest approval on file (Drugs@FDA) | June 8, 1954 | October 19, 2010 |
| First generic approved | March 26, 1997 | March 11, 2020 |
| Generic labelers (NDC) | 19 labelers | 16 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.093 per tablet (Warfarin sodium 2 mg tablet) | $0.795 per capsule (Dabigatran etexilate 150 mg capsule) |
| 12-month price change | +2% | -31% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 7 | 9 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 127,492 | 78,424 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
Do their labels mention each other?
Warfarin label, drug interactionsDrug Class: Anticoagulants; Specific Drugs: argatroban, dabigatran, bivalirudin, desirudin, heparin, lepirudin
Dabigatran label, warnings and precautions… mechanical prosthetic heart valves (recently implanted or implanted more than three months prior to enrollment) were randomized to dose-adjusted warfarin or 150 mg, 220 mg, or 300 mg of PRADAXA Capsules twice a day.
Source: FDA drug labels via openFDA
What next?
- Alternatives to warfarin
- every medicine labeled for the same conditions