Dabigatran — Membership Pricing

Related medications

Other medications associated with the same conditions in this catalog.

Also listed for Atrial Fibrillation (Stroke Prevention)

• Warfarin Sodium
• Amiodarone
• Apixaban
• Digoxin
• Metoprolol
• Rivaroxaban
• Warfarin

Other medications in Cardiovascular

• Enoxaparin
• Nitroglycerin
• Spironolactone
• Aspirin
• Cilostazol
• Clopidogrel

What Dabigatran is approved for (FDA label)

Dabigatran Etexilate 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 to 10 days ( 1.2 ) To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3 ) For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery ( 1.4 ) For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days ( 1.5 ) To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated ( 1.6 ) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients Dabigatran Etexilate Capsules is indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. 1.2 Treatment of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients Dabigatran Etexilate Capsules is indicated for the treatment of deep venous thrombosis and pulmonary embolism in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days. 1.3 Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients Dabigatran Etexilate Capsules is indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated. 1.4 Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism in Adult Patients Following Hip Replacement Surgery Dabigatran Etexilate Capsules is indicated for the prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients who have undergone hip replacement surgery. 1.5 Treatment of Venous Thromboembolic Events in Pediatric Patients Dabigatran Etexilate Capsules is indicated for the treatment of venous thromboembolic events (VET) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days [see Dosage and Administration (2.3)]. 1.6 Reduction in the Risk of Recurrence of Venous Thromboembolic Events in Pediatric Patients Dabigatran Etexilate Capsules is indicated to reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated [see Dosage and Administration (2.3)].

Source: Read the full FDA label on DailyMed. Label effective date: August 3, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Dabigatran (FDA label)

WARNING: (A) PREMATURE DISCONTINUATION OF DABIGATRAN ETEXILATE CAPSULES INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA (A) PREMATURE DISCONTINUATION OF DABIGATRAN ETEXILATE CAPSULES INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including Dabigatran Etexilate Capsules, increases the risk of thrombotic events. If anticoagulation with Dabigatran Etexilate Capsules is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration ( 2.6 , 2.7 , 2.8 ) and Warnings and Precautions ( 5.1 )]. (B) SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients treated with Dabigatran Etexilate Capsules who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants a history of traumatic or repeated epidural or spinal punctures a history of spinal deformity or spinal surgery optimal timing between the administration of Dabigatran Etexilate Capsules and neuraxial procedures is not known [see Warnings and Precautions ( 5.3 )]. Monitor patients frequently for signs and symptoms of neurological impairment.

Source: FDA prescribing information (DailyMed). Set ID: 3a8ec82a-c367-40dc-9302-e1896fcb05ea. SPL document ID: d2fd635f-6c0f-4509-8c91-348c1b73ca45. Label effective date: August 3, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Dabigatran (FDA label)

150 mg capsules with a white to pale yellow pellets filled in HPMC capsule size “0EL” light navy blue opaque cap and light cream opaque body imprinted with “150” on body and “DAB” on cap in black ink. 110 mg capsules with a white to pale yellow pellets filled in HPMC capsule size "0" light blue opaque body and light blue opaque cap imprinted with "110" on body and "Dab" on cap in black ink. 75 mg capsules with a white to pale yellow pellets filled in HPMC capsule size “1” light cream opaque cap and light cream opaque body imprinted with “DAB” on cap and “75” on body in black ink.

Source: FDA prescribing information (DailyMed). Set ID: 3a8ec82a-c367-40dc-9302-e1896fcb05ea. SPL document ID: d2fd635f-6c0f-4509-8c91-348c1b73ca45. Label effective date: August 3, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Dabigatran (FDA label)

The following clinically significant adverse reactions are described elsewhere in the labeling: Increased Risk of Thrombotic Events after Premature Discontinuation [see Warnings and Precautions (5.1)] Risk of Bleeding [see Warnings and Precautions (5.2)] Spinal/Epidural Anesthesia or Puncture [see Warnings and Precautions (5.3)] Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves [see Warnings and Precautions (5.4)] Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome [see Warnings and Precautions (5.6)] The most serious adverse reactions reported with Dabigatran Etexilate Capsules were related to bleeding [see Warnings and Precautions (5.2)] . Most common adverse reactions (>15%) are gastrointestinal adverse reactions and bleeding ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Source: FDA prescribing information (DailyMed). Set ID: 3a8ec82a-c367-40dc-9302-e1896fcb05ea. SPL document ID: d2fd635f-6c0f-4509-8c91-348c1b73ca45. Label effective date: August 3, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Dabigatran (FDA label)

Dabigatran Etexilate Capsules is contraindicated in patients with: • Active pathological bleeding [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 )] • History of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of the product (e.g., anaphylactic reaction or anaphylactic shock) [see Adverse Reactions ( 6.1 )] • Mechanical prosthetic heart valve [see Warnings and Precautions ( 5.4 )] • Active pathological bleeding ( 4) • History of serious hypersensitivity reaction to Dabigatran Etexilate Capsules ( 4 ) • Mechanical prosthetic heart valve ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: 3a8ec82a-c367-40dc-9302-e1896fcb05ea. SPL document ID: d2fd635f-6c0f-4509-8c91-348c1b73ca45. Label effective date: August 3, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Dabigatran (FDA label)

• Bleeding: Dabigatran Etexilate Capsules can cause serious and fatal bleeding ( 5.2 ) • Bioprosthetic heart valves: Dabigatran Etexilate Capsules use not recommended ( 5.4 ) • Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome: Dabigatran Etexilate Capsules use not recommended ( 5.6 ) 5.1 Increased Risk of Thrombotic Events after Premature Discontinuation Premature discontinuation of any oral anticoagulant, including Dabigatran Etexilate Capsules, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. If Dabigatran Etexilate Capsules is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant and restart Dabigatran Etexilate Capsules as soon as medically appropriate [see Dosage and Administration (2.6, 2.7, 2.8)]. 5.2 Risk of Bleeding Dabigatran Etexilate Capsules increases the risk of bleeding and can cause significant and, sometimes, fatal bleeding.

Source: FDA prescribing information (DailyMed). Set ID: 3a8ec82a-c367-40dc-9302-e1896fcb05ea. SPL document ID: d2fd635f-6c0f-4509-8c91-348c1b73ca45. Label effective date: August 3, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Dabigatran (FDA label)

P-gp inducers: Avoid coadministration with Dabigatran Etexilate Capsules ( 5.5 ) P-gp inhibitors in adult patients with CrCl 30 to 50 mL/min: Reduce dosage or avoid ( 7 ) P-gp inhibitors in adult patients with CrCl <30 mL/min: Not recommended ( 7 ) 7.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients The concomitant use of Dabigatran Etexilate Capsules with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided [see Clinical Pharmacology (12.3)] . P-gp inhibition and impaired renal function are the major independent factors that result in increased exposure to dabigatran [see Clinical Pharmacology (12.3)] . Concomitant use of P-gp inhibitors in patients with renal impairment is expected to produce increased exposure of dabigatran compared to that seen with either factor alone.

Source: FDA prescribing information (DailyMed). Set ID: 3a8ec82a-c367-40dc-9302-e1896fcb05ea. SPL document ID: d2fd635f-6c0f-4509-8c91-348c1b73ca45. Label effective date: August 3, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.