Dabigatran Etexilate is a direct thrombin inhibitor sold in the U.S. under 2 brand and generic names, for pulmonary embolism and venous thrombosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Pradaxa (application NDA022512). Other dabigatran etexilate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Non-valvular Atrial Fibrillation in Adult Patients: For patients with CrCl > 30 mL/min: 150 mg orally, twice daily ( 2.2 ) For patients with CrCl 15-30 mL/min: 75 mg orally, twice daily ( 2.2 ) Treatment of DVT and PE in Adult Patients: For patients with CrCl > 30 mL/min: 150 mg orally, twice daily after 5-10 days of parenteral anticoagulation ( 2.2 ) Reduction in the Risk of Recurrence of DVT and PE in Adult Patients: For patients with CrCl > 30 mL/min: 150 mg orally, twice daily after previous treatment ( 2.2 ) Prophylaxis of DVT and PE Following Hip Replacement Surgery in Adult Patients: For patients with CrCl > 30 mL/min: 110 mg orally first day, then 220 mg once daily ( 2.2 ) Treatment of Pediatric VTE: For pediatric patients: weight-based dosage, twice daily after at least 5 days of parenteral anticoagulant ( 2.3 ) Reduction in the Risk of Recurrence of Pediatric VTE: For pediatric patients: weight-based dosage, twice daily after previous treatment ( 2.3 ) Pradaxa Capsules are NOT substitutable on a milligram-to-milligram basis with other dabigatran etexilate dosage forms Review recommendations for converting to or from other oral or parenteral anticoagulants ( 2.6 , 2.7 ) Temporarily discontinue PRADAXA before invasive or surgical procedures when possible, then restart promptly ( 2.8 ) 2.1 Important Dosage Information Dabigatran etexilate is available in different…
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 PRADAXA 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 Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 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. Adult Trials Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation The RE-LY (Randomized Evaluation of Long-term…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Capsule | Generic | $28 | View → | |
| 2 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| R110 | 110 mg | blue | capsule | — |
| R75 | 75 mg | white | capsule | — |
| R150 | 150 mg | blue, white | capsule | — |
| R150 | 150 mg | blue, white | capsule | — |
| R150; | 150 mg | blue, white | capsule | — |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
PRADAXA 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 PRADAXA ( 4 ) Mechanical prosthetic heart valve ( 4 )
P-gp inducers: Avoid coadministration with PRADAXA ( 5.5 ) P-gp inhibitors in adult patients with CrCl 30-50 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 PRADAXA 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. In patients with moderate renal impairment (CrCl 30-50 mL/min), reduce the dosage of PRADAXA to 75 mg twice daily when administered concomitantly with the P-gp inhibitors dronedarone or systemic ketoconazole. The use of the P-gp inhibitors verapamil, amiodarone, quinidine, clarithromycin, and ticagrelor does not require a dosage adjustment of PRADAXA. These results should not be extrapolated to other P-gp inhibitors [see Warnings and Precautions (5.5) , Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ] . The…
| 68/100 |
| Prescription |
| Capsule |
| Generic |
| $28 |
| View → |