Two medicines, side by side
Dabigatran vs rivaroxaban
Dabigatran and rivaroxaban are both labeled for atrial fibrillation, blood clots (DVT and PE) and stroke prevention. Drugs@FDA records approvals of dabigatran since 2010 and of rivaroxaban since 2011. Pharmacies paid $0.795 per dabigatran etexilate 150 mg capsule and $0.650 per rivaroxaban 2.5 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Rivaroxaban's other strengths are brand-only: $19.54 per Xarelto 20 mg tablet. In FDA's classes, dabigatran is a direct thrombin inhibitor and rivaroxaban a factor xa inhibitor.
Check it at the source: the dabigatran FDA label on DailyMed (effective June 25, 2025); the rivaroxaban FDA label on DailyMed (effective September 10, 2026).
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
Highlights of the rivaroxaban record
Rivaroxaban (Xarelto) · label of September 10, 2026
(A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA A. Premature discontinuation of XARELTO increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including XARELTO, increases the risk of thrombotic events.
Used for
From the label: indicationsXARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation ( 1.1 ) for treatment of deep vein thrombosis (DVT) ( 1.2 ) for treatment of pulmonary embolism (PE) ( 1.3 ) for reduction in the risk of recurrence of DVT or PE ( 1.4 ) for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery ( 1.5 ) for […]
On the market
- Earliest approval on file
- July 1, 2011
- Generic labelers
- 20 labelers
- Pharmacy cost
- $0.650 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 1
Source: FDA drug labels via openFDA (Dabigatran label of June 25, 2025, Rivaroxaban label of September 10, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do dabigatran and rivaroxaban differ on the record?
In FDA's classes, dabigatran is a direct thrombin inhibitor and rivaroxaban a factor xa inhibitor.
How each works, in its label's words: Dabigatran, “Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors.”; Rivaroxaban, “XARELTO is a selective inhibitor of FXa.”
Half-life, in each label's words: Dabigatran, “The half-life of dabigatran in healthy adult subjects is 12 to 17 hours.”; Rivaroxaban, “The terminal elimination half-life of rivaroxaban is 5 to 9 hours in healthy subjects aged 20 to 45 years.”
Both labels carry a boxed warning; the records quote them.
Generics: dabigatran since 2020; rivaroxaban since 2025 (Drugs@FDA).
| Dabigatran | Rivaroxaban | |
|---|---|---|
| Labeled for | Atrial fibrillation, Blood clots (DVT and PE), Stroke prevention | Atrial fibrillation, Heart attack and coronary artery disease, Blood clots (DVT and PE), Stroke prevention |
| Pharmacologic class | Direct Thrombin Inhibitor | Factor Xa Inhibitor |
| How it works (label) | Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors. | XARELTO is a selective inhibitor of FXa. It does not require a cofactor (such as Anti-thrombin III) for activity. Rivaroxaban inhibits free FXa and prothrombinase activity. |
| Half-life (label) | The half-life of dabigatran in healthy adult subjects is 12 to 17 hours. | The terminal elimination half-life of rivaroxaban is 5 to 9 hours in healthy subjects aged 20 to 45 years. |
| Earliest approval on file (Drugs@FDA) | October 19, 2010 | July 1, 2011 |
| First generic approved | March 11, 2020 | March 3, 2025 |
| Generic labelers (NDC) | 16 labelers | 20 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.795 per capsule (Dabigatran etexilate 150 mg capsule) | $0.650 per tablet (Rivaroxaban 2.5 mg tablet) |
| 12-month price change | -31% | -81% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 9 | 1 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 78,424 | 206,938 |
| 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)
What do the labels say about using others of their kind?
Rivaroxaban label, drug interactionsAvoid concurrent use of XARELTO with other anticoagulants due to increased bleeding risk unless benefit outweighs risk.
Source: FDA drug labels via openFDA
What next?
- Alternatives to dabigatran
- every medicine labeled for the same conditions