Pradaxa

Pradaxa is a direct thrombin inhibitor that helps reduce the formation of blood clots, especially in people with an irregular pulse (atrial fibrillation) that is not caused by a heart valve problem. The medication works by blocking thrombin, a key enzyme involved in the blood clotting process.

Pradaxa received FDA approval in October 2010 for stroke prevention in atrial fibrillation (AF) patients, and in 2015, the medication was also approved for treatment and prevention of DVT and PE. Doctors have written more than 17 million Pradaxa prescriptions in the United States.

Initially, Pradaxa was widely embraced by medical professionals and patients as a convenient alternative to warfarin, which had been the only oral anticoagulant available in the United States for stroke reduction. Unlike with warfarin, patients taking Pradaxa are not required to undergo regular blood tests or maintain a strict diet.

Bleeding, sometimes serious, is the most common side effect of Pradaxa. Additionally, over 15% of patients taking Pradaxa experience adverse gastrointestinal effects. These include abdominal pain, gastritis, gastroesophageal reflux disease (GERD) and gastric bleeding.

As of Oct. 28, 2025, bleeding and stroke were the most common Pradaxa side effects reported to the FDA. Gastrointestinal bleeding was the most commonly reported type of bleeding, accounting for 12% of all adverse event reports. Fall, anemia and rectal bleeding were other reported adverse reactions.

Over 76% of the adverse events reported to the FDA were serious. The number of reported cases peaked in 2011 and remained high through 2014. This coincides with the release of FDA safety warnings for many of the most reported side effects.

In clinical trials, gastrointestinal bleeding was more common among patients taking Pradaxa compared to those on warfarin.

“To minimize the gastrointestinal issues, Pradaxa can be taken with meals,” clinical pharmacist Kenneth S. Fill told Drugwatch. “Be extra cautious during physical activities to reduce the chance of minor or major bruising.”

Serious Side Effects

Bleeding risks, such as hemorrhaging, gastrointestinal bleeding and stroke, are serious potential Pradaxa side effects. Gastrointestinal and internal eye bleeding were the most common types of bleeding reported in clinical trials.

There is also a risk of hematomas (pooled blood). In rare cases, patients reported severe allergic reactions, including anaphylaxis, when taking Pradaxa.

“Signs and symptoms to look out for include unusual or prolonged bleeding, excessive bruising, and blood in the urine or stool,” Fill said.

Notify your doctor immediately if you notice any symptoms of bleeding disorders, such as bleeding from your gums, frequent nose bleeds or heavy periods. However, you generally shouldn’t stop taking Pradaxa without speaking to your doctor.

“Stopping Pradaxa abruptly can lead to a rebound effect where the risk of blood clots increases,” Fill said. “This is particularly dangerous for those that are prone to or at a high risk of stroke or thromboembolism.”

Before the development of Pradaxa reversal agents — a substance that can counter the effects of another drug — there was no means to reverse the effects of Pradaxa, unlike warfarin, which had a reversal agent. Many people died as a result of uncontrolled bleeding when medical care providers were unable to do anything to stop it.

John Thomas Wilchinski, a resident of Greenville County, Tennessee, was prescribed Pradaxa in February 2011. After just two months of use, he suffered a severe cerebral hemorrhage, according to court documents. This is a life-threatening type of bleeding in the brain. This serious side effect has had lasting impacts on his health and well-being.

Permanent Injuries

As a result of the cerebral hemorrhage caused by Pradaxa, Wilchinski faced permanent injuries. These include ongoing physical pain, mental anguish, and diminished enjoyment of life. His condition requires lifelong medical treatment and continuous monitoring.

Ongoing Health Concerns

The side effects of Pradaxa left Wilchinski with a fear of future health complications. His experience highlights the significant risks associated with Pradaxa. Especially challenging was the lack of a reversal antidote at that time. This made managing his bleeding events extremely difficult, according to court records. While Pradaxa has an antidote called idarucizumab, the FDA didn’t approve its use until 2015. Wilchinski’s incident occurred in 2012.

The boxed warning for Pradaxa’s prescribing information covers two conditions: thrombotic events and epidural or spinal hematomas. Boxed warnings are the most serious drug label warning the FDA issues.

Because there is an increased risk of blood clots among patients who discontinue treatment with Pradaxa, the boxed warning cautions against stopping an anticoagulant without replacing it with another medication.

Additionally, in patients taking Pradaxa, blood may pool against the spine during spinal punctures and certain types of spinal anesthesia. This condition, called a spinal hematoma, can lead to permanent paralysis.

The FDA first issued a Drug Safety Communication on Dec. 7, 2011, alerting consumers to reports about serious bleeding in Pradaxa users. There were numerous additional FDA communications since then, including but not limited to the following:

There is mixed evidence on how Pradaxa compares to other blood thinners. A 2019 study in the American Journal of Medicine examined the safety profiles of several blood thinners in Medicare patients. The results showed a slightly decreased risk of internal bleeding in the brain or skull when taking Pradaxa compared to similar medications.

However, a 2021 meta-analysis published in Frontiers’ Journal of Pharmacology found that Pradaxa has an increased rate of gastrointestinal bleeding, and an older 2014 article from the Journal of the American Heart Association found that patients on dabigatran, the active ingredient in Pradaxa, have a 33% increased risk of heart attack compared to warfarin users.

Careful monitoring can reduce the dangers of major bleeding and related complications.

When Pradaxa first came onto the market, there were no reversal agents. This means there was no effective way to stop uncontrolled bleeding caused by Pradaxa.

In 2015, the FDA granted accelerated approval for a drug called Praxbind (idarucizumab), which was the first reversal agent for Pradaxa-related bleeding. When preliminary evidence suggests a drug can address a medical need that other approved medications can’t, it may be granted accelerated approval to meet that demand. Although accelerated approval requires less evidence than the typical approval process, Praxbind did get full approval later in 2018.

Praxbind works by binding to dabigatran and neutralizing its anticoagulant effects within minutes. This medication can be used in cases where a patient taking Pradaxa requires emergency surgery or if a Pradaxa user develops uncontrolled bleeding.

Despite Praxbind’s use as an emergency option, it did not eliminate legal concerns nor help the patients or their families who had been affected by Pradaxa-related complications before the release of Praxbind.

Despite the risks associated with Pradaxa, the medication was never recalled.

A 2012 FDA recall did occur and affected a single lot of the medication. The recall was prompted by a packaging defect that could potentially compromise the integrity of the medication by allowing moisture to get into the packaging.

In 2023, Ascend Laboratories LLC. also recalled Dabigatran Etexilate Capsules due to elevated levels of N-Nitroso-dabigatran. Although this chemical is commonly found in places like drinking water and vegetables, high doses can potentially cause cancer. The recalled capsules included a generic version of Pradaxa.

Pradaxa’s manufacturer, Boehringer Ingelheim Pharmaceuticals, was sued by thousands of patients for allegedly failing to disclose the risk of serious complications. In their Pradaxa lawsuits, plaintiffs claimed that the company:

Boehringer Ingelheim Pharmaceuticals settled the majority of claims in 2014 and the remainder of the claims in 2020. The company paid out $650 million in settlements, with the average compensation per person being around $160,000.

What Patients Should Know and Do Next

Patients who use Pradaxa should consult their doctors if they experience any unusual symptoms, including unexplained bruising, bloody urine or fatigue. These symptoms could be a sign of internal bleeding or other complications. Patients are also advised to monitor both kidney function and clotting parameters, especially if they are long-term users.

If patients experience complications, they should report them to the FDA’s MedWatch program. Speaking with an experienced attorney can help you understand your legal options if you suffered harm from Pradaxa.