Prescription medicine
Dabigatran Brand names: Pradaxa
Dabigatran (Pradaxa) is a prescription medicine with an FDA approval on record since 2010. FDA's NDC Directory lists it from 16 generic labelers, and pharmacies paid $0.795 per dabigatran etexilate 150 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the dabigatran FDA label on DailyMed (effective June 25, 2025, Boehringer Ingelheim Pharmaceuticals Inc.); the NDA 22512 record on Drugs@FDA; every dabigatran label on DailyMed.
Highlights of the record
FDA label of June 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
(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. To reduce this risk, consider coverage with another anticoagulant if PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy ( 2.6 , 2.7 , 2.8 , 5.1 ). (B) SPINAL/EPIDURAL HEMATOMA: Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis ( 5.3 ). Monitor patients frequently for signs and symptoms of neurological impairment and if observed, treat urgently. Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated ( 5.3 ). (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: indications and usagePRADAXA 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
Forms and strengths
- 20 mg
- 30 mg
- 40 mg
- 50 mg
- 75 mg
- 110 mg
- 150 mg
Capsule; capsule (coated pellets); pellet.
On the market
- Earliest approval on file
- October 19, 2010 Pradaxa, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first March 11, 2020; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 18 of which 16 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- March 7, 2026 Pradaxa pellets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.795 per capsule Dabigatran etexilate 150 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 9 since 2023 0 Class I among all firms' recalls; latest July 16, 2026
- FAERS reports
- 78,424 through July 30, 2026
What is dabigatran used for?
From the label: indications and usagePRADAXA 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 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 […]
Conditions named in the indications of dabigatran's FDA labels, with every medicine labeled for each:
From other dabigatran labelsStroke prevention: Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients PRADAXA Capsules is indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.
FDA pharmacologic class: Direct Thrombin Inhibitor.
Source: FDA drug label (Pradaxa), Boehringer Ingelheim Pharmaceuticals Inc., effective June 25, 2025 (SPL set ba74e3cd-b06f-4145-b284-5fd6b84ff3c9), via openFDA; the full label on DailyMed
What does the patient leaflet for dabigatran say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about PRADAXA?People with atrial fibrillation (a type of irregular heartbeat) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. PRADAXA lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking PRADAXA, you may have increased risk of forming a clot in your blood. Do not stop taking PRADAXA Capsules without talking to the healthcare provider who prescribes it for you. Stopping PRADAXA increases your risk of having a stroke. PRADAXA may need to be stopped, if possible, before surgery or a medical or dental procedure. Ask the healthcare provider who prescribed PRADAXA for you when you should stop taking it. Your healthcare provider will tell you when you may start taking PRADAXA again after your surgery or procedure. If you have to stop taking PRADAXA, your healthcare provider may prescribe another medicine to help prevent a blood clot from forming. […] During treatment with PRADAXA: you may bruise more easily it may take longer for any bleeding to stop Call your healthcare provider or get medical help right away if you have any of these signs or symptoms of bleeding: unexpected bleeding or bleeding that lasts a long time, such as: unusual bleeding from the gums nose bleeds that happen often menstrual bleeding or vaginal bleeding that is heavier than normal bleeding that is severe or you cannot control pink or brown urine red or black stools (looks like tar) bruises that happen without a known cause or get larger cough up blood or blood clots vomit blood or your vomit looks like "coffee grounds" unexpected pain, swelling, or joint pain headaches, feeling dizzy or weak Take PRADAXA Capsules exactly as prescribed. […]
From the patient leaflet: How should I store PRADAXA Capsules?Store PRADAXA Capsules at room temperature 68°F to 77°F (20°C to 25°C). After opening the bottle, use PRADAXA Capsules within 4 months. Safely throw away any unused PRADAXA Capsules after 4 months. Keep PRADAXA Capsules in the original bottle or blister package to keep them dry (protect the capsules from moisture). Do not put PRADAXA Capsules in pill boxes or pill organizers. Tightly close your bottle of PRADAXA Capsules right away after you take your dose. Keep PRADAXA Capsules and all medicines out of the reach of children.
Source: FDA drug label (Pradaxa), Boehringer Ingelheim Pharmaceuticals Inc., effective June 25, 2025 (SPL set ba74e3cd-b06f-4145-b284-5fd6b84ff3c9), via openFDA; the full label on DailyMed
Is there a generic for dabigatran (Pradaxa)?
The FDA approved the first generic dabigatran on March 11, 2020. 9 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists dabigatran from 16 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Pradaxa pellets: the compound patent runs to September 7, 2025 (pediatric exclusivity to March 7, 2026); a patent listed only for Pradaxa capsules runs to July 20, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2010 earliest approval on file
- 2020 first generic approved
- 2026 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dabigatran (Pradaxa)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.795 per Dabigatran etexilate 150 mg capsule, down 31% from $1.15 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Dabigatran etexilate 150 mg capsule (generic)
- Pradaxa 150 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dabigatran etexilate 110 mg capsule | Generic | $0.938 per capsule | $28.13 | -49% |
| Dabigatran etexilate 150 mg capsule | Generic | $0.795 per capsule | $23.84 | -31% |
| Dabigatran etexilate 75 mg capsule | Generic | $0.750 per capsule | $22.51 | -32% |
| Pradaxa 110 mg capsule | Brand | $3.17 per capsule | $94.99 | +0.1% |
| Pradaxa 150 mg capsule | Brand | $3.16 per capsule | $94.79 | -0.3% |
| Pradaxa 75 mg capsule | Brand | $3.17 per capsule | $95.01 | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has dabigatran been recalled?
The FDA's Enforcement Report lists 9 recalls naming dabigatran since 2023: 0 Class I (the most serious), 4 Class II, 5 Class III; 9 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 16, 2026 | Class III | Ascend Laboratories, LLC | Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for … |
| June 30, 2026 | Class III | Ascend Laboratories, LLC | Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and … |
| December 12, 2024 | Class II | Ascend Laboratories, LLC | CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit |
| March 14, 2023 | Class II | Ascend Laboratories, LLC | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the dabigatran label say about other medicines?
The dabigatran label names 12 other medicines in its interaction, contraindication or warning sections. The labels of 30 other medicines name dabigatran. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | The use of the P-gp inhibitors verapamil, amiodarone, quinidine, clarithromycin, and ticagrelor does not require a dosage adjustment of PRADAXA. |
| Clarithromycin | drug interactions | The use of the P-gp inhibitors verapamil, amiodarone, quinidine, clarithromycin, and ticagrelor does not require a dosage adjustment of PRADAXA. |
| Dronedarone | drug interactions | 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. |
| Heparin | warnings and precautions | Risk factors for bleeding include the concomitant use of other drugs that increase the risk of bleeding (e.g., anti-platelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs). |
| Idarucizumab | warnings and precautions | For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding In pediatric patients, the efficacy and safety of idarucizumab have not been established. |
| Ketoconazole | drug interactions | 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. |
| Protamine | warnings and precautions | Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of dabigatran. |
| Quinidine | drug interactions | The use of the P-gp inhibitors verapamil, amiodarone, quinidine, clarithromycin, and ticagrelor does not require a dosage adjustment of PRADAXA. |
| Rifampin | drug interactions | 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) ]. |
| Ticagrelor | drug interactions | The use of the P-gp inhibitors verapamil, amiodarone, quinidine, clarithromycin, and ticagrelor does not require a dosage adjustment of PRADAXA. |
| Verapamil | drug interactions | The use of the P-gp inhibitors verapamil, amiodarone, quinidine, clarithromycin, and ticagrelor does not require a dosage adjustment of PRADAXA. |
| Warfarin | warnings and precautions | … (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. |
Other labels that name dabigatran
Source: FDA drug label (Pradaxa), Boehringer Ingelheim Pharmaceuticals Inc., effective June 25, 2025 (SPL set ba74e3cd-b06f-4145-b284-5fd6b84ff3c9), via openFDA; the full label on DailyMed
What do FAERS reports show for dabigatran?
The FDA Adverse Event Reporting System holds 78,424 reports that list dabigatran among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11,539 are coded as a death and 40,215 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as dabigatran?
4 other medicines are given the same way (oral) and in the same FDA class as dabigatran or labeled mainly for the same use (atrial fibrillation), the same class first. Atrial fibrillation lists all 17 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Warfarin | Atrial fibrillation, Blood clots (DVT and PE) | 19 labelers | $0.093 per tablet 2 mg tablet | No current entry |
| Rivaroxaban | Atrial fibrillation, Blood clots (DVT and PE), Stroke prevention | 20 labelers | $0.650 per tablet 2.5 mg tablet | A presentation being discontinued |
| Apixaban | Atrial fibrillation, Blood clots (DVT and PE), Stroke prevention | 2 labelers | $5.52 per tablet 5 mg tablet | No current entry |
| Edoxaban | Atrial fibrillation, Blood clots (DVT and PE), Stroke prevention | none listed | $15.51 per tablet 60 mg tablet | No current entry |
Every medicine labeled for the same conditions as dabigatran
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does dabigatran compare with medicines for the same use?
3 side-by-side pages set dabigatran beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to dabigatran
- 4 medicines for the same use
- Other direct thrombin inhibitors
- the pharmacologic class, with prices and generics
- Dabigatran side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other