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Pradaxa Side Effects

Patients who take the blood thinner Pradaxa (dabigatran etexilate) are at risk for serious, uncontrolled bleeding. This side effect can be fatal. Other potential serious side effects of Pradaxa include heart attack and liver damage. More common side effects of Pradaxa include stomach pain and indigestion.

Pradaxa
Pradaxa Side Effects
  1. Uncontrolled bleeding Can be fatal; antidote available
  2. Gastrointestinal effects Includes pain, swelling and gastritis
  3. Heart attack More likely in Pradaxa patients than in those taking warfarin
  4. Allergic reactions Signs include swelling of the face, wheezing, tightness in the chest
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Pradaxa side effects range from indigestion to life-threatening, uncontrolled bleeding.

The U.S. Food and Drug Administration warns that taking Pradaxa may cause patients to bruise more easily. It may take longer for any bleeding to stop while using the drug, the agency says.

The FDA also requires Pradaxa labels to include a black box warning about hematomas and dangers associated with stopping Pradaxa.

Pradaxa was the most frequently mentioned drug in the FDA database of adverse event reports in 2011. Oxford Academic defines an adverse event as an injury from a drug or medical device that results in prolonged hospitalization, disability or death.

The Institute for Safe Medication Practices looked at adverse event reports again in 2015. Pradaxa continued to have the largest number of overall serious reports in the U.S. It also had the largest total number of reported severe hemorrhages and the most patient deaths.

Adverse events reported with Pradaxa use include:
  • Deaths
  • Hemorrhage (bleeding)
  • Acute kidney failure
  • Stroke
  • Suspected liver failure

Pradaxa Bleeding

Internal bleeding is the most frequently reported Pradaxa side effect. People have died from this side effect.

The body usually stops itself from bleeding too much by forming clots in the blood. Pradaxa stops naturally occurring clots from forming. It reduces the body’s ability to stop bleeding after an injury. Patients taking the drug may bleed uncontrollably.

The Pradaxa drug label includes a warning about significant and sometimes fatal bleeds. The FDA says bleeding that can be serious and even fatal is a well-recognized complication of all blood thinners.

Pradaxa Gastrointestinal Bleeding

Using Pradaxa increases the risk of major gastrointestinal bleeding. In a major trial, gastrointestinal bleeds were reported at a rate of 1.59 percent a year.

In May 2014, the FDA alerted the public of an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The announcement came following a new Pradaxa study that included information from more than 134,000 Medicare patients older than 64.

Pradaxa Brain Bleed

Internal brain hemorrhage illustration
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Brain bleeds are the most devastating complication of blood thinners like Pradaxa. Source: ahajournals.org

Hemorrhages in the brain and central nervous system caused by Pradaxa can be as harmful as a stroke. Researchers say brain bleeds are the most devastating complication of blood thinners.

Pradaxa is associated with a higher risk of intracranial hemorrhage. Pradaxa patients in a study experienced intracranial bleeds at a rate of 0.22 percent a year, according to the drug label.

Pradaxa Rectal Bleed

Studies have not reported the rates of rectal bleeds with Pradaxa use. However, bleeds other than the reported types were seen at a rate of 0.17 percent a year.

Researchers looked at two reported cases of severe rectal bleeding in patients who took Pradaxa. One was a 79-year-old woman who was admitted to the hospital two months after she started taking Pradaxa. The other was an 84-year-old man. Both took 110 mg of Pradaxa twice daily to treat chronic atrial fibrillation.

“In both cases, an objective causality assessment revealed that those adverse reactions were probably related to dabigatran etexilate,” the researchers wrote.

The peer-reviewed journal Annals of Pharmacotherapy published the findings in June 2012.

Symptoms of Pradaxa Bleeding

Patients should seek emergency help right away if they show symptoms of bleeding.

Pradaxa bleeding symptoms include:
  • Joint pain, swelling or discomfort joint
  • Headaches
  • Dizziness or weakness
  • Reoccurring nose bleeds
  • Bruises that happen without a known cause or that get larger
  • Bleeding from a cut that takes a long time to stop
  • Unusual gum bleeding
  • Heavier than usual menstrual or vaginal bleeding
  • Pink or brown urine
  • Red or black stools (looks like tar)
  • Coughing up blood or blood clots
  • Vomiting blood or vomit that looks like coffee grounds

Pradaxa Bleeding Risk Factors

There is a risk of bleeding for anyone who takes Pradaxa. Certain groups of people are more at risk than others.

The risk of bleeding is highest in people:
  • Age 75 and over
  • With a stomach ulcer
  • With recent or recurrent stomach or intestinal bleeding
  • With kidney problems
  • With a low body weight
  • Who take other medicines that increase the risk of bleeding (aspirin, blood thinners and non-steroidal anti-inflammatory drugs)
  • Who take dronedarone or ketoconazole for kidney problems

Pradaxa Bleeding Antidote

For the first five years Pradaxa was sold in the U.S., there was no way for doctors to stop internal hemorrhaging caused by the drug.

The FDA granted conditional approval for a Pradaxa bleeding antidote in October 2015. The agency gave full approval for the reversal agent Praxbind (idariocozumab) in 2018.

Researchers found that Praxbind reversed the anticoagulant effect of Pradaxa within four hours in the majority of patients.

Praxbind is stocked in more than 3,000 hospitals in all 50 states, according to manufacturer Boehringer Ingelheim. Patients and healthcare providers can find where the antidote is stocked by using a tool on Praxbind.com.

Thousands of people who blame Pradaxa for bleeding injuries and deaths have filed lawsuits against Boehringer Ingelheim. Many of the Pradaxa lawsuits allege that the company developed the bleeding remedy in 2010 but didn’t seek approval for Praxbind until February 2015.

Pradaxa Black Box Warning: Hematomas and Stopping Pradaxa

The FDA requires a black box warning — the agency’s strongest warning — to alert the public of the risk of spinal and epidural hematomas in patients treated with Pradaxa who are receiving neuraxial anesthesia or undergoing spinal puncture.

The black box warning also cautions that suddenly stopping Pradaxa increases the risk of blood clot and stroke.

Gastrointestinal Side Effects with Pradaxa

Patients taking 150 mg of Pradaxa had an increased incidence of gastrointestinal adverse reactions in clinical trials.

Reported gastrointestinal side effects include:
  • Abdominal pain and discomfort
  • Gastroesophageal reflux disease (GERD)
  • Esophagitis
  • Erosive gastritis
  • Gastric hemorrhage
  • Hemorrhagic gastritis
  • Hemorrhagic erosive gastritis
  • Gastrointestinal ulcer
  • Skin rash
  • Itchy skin
  • Swelling

Pradaxa and Heart Attack

Infographic about how Pradaxa causes a 33% increased risk of heart attack
Pradaxa Heart Attack Statistic Source: cleveland.com

A March 2012 study found that patients taking Pradaxa were more likely to have heart attacks than those taking warfarin. Researchers analyzed five trials of 30,470 patients. They used information from the U.S. National Institute of Health MEDLINE database. They published their findings in the Journal of the American College of Cardiology.

That same month, a Cleveland Clinic study published in the Archives of Internal Medicine found similar results. The study compared warfarin and Pradaxa. It found that Pradaxa causes a 33 percent increased risk of heart attack or severe symptoms of heart disease. Those symptoms can include chest pain, dizziness, shortness of breath and loss of consciousness.

Pradaxa Allergic Reaction

Some patients who use Pradaxa may develop allergic symptoms. Patients should get medical help right away or tell their doctor if they notice any of the symptoms of an allergic reaction.

Symptoms of Pradaxa allergic reaction include:
  • Chest pains or tightness
  • Swelling of the face or tongue
  • Difficulty breathing or wheezing
  • Feeling dizzy or faint

Common Pradaxa Side Effects

Pradaxa’s maker lists the drug’s common side effects as indigestion, upset stomach, burning and stomach pain. Stroke, acute kidney failure and suspected liver failure have also been reported with Pradaxa use.

Common side effects of Pradaxa include:
  • Indigestion
  • Upset stomach
  • Burning
  • Stomach pain

Please seek the advice of a medical professional before making health care decisions.

Related Pages

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15 Cited Research Articles

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  2. U.S. Food and Drug Administration. (n.d.). Pradaxa label information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022512s027lbl.pdf
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  4. Cision PR Newswire. (2018, April 17). FDA Provides Full Approval to Praxbine, Specific Reversal Agent for Pradaxa. Retrieved From https://www.prnewswire.com/news-releases/fda-provides-full-approval-to-praxbind-specific-reversal-agent-for-pradaxa-300631175.html
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  6. Kaiser Permanente. (2011, January 24). Warfarin (Coumadin®) or Dabigatran (Pradaxa®) How do these blood thinners compare? Retrieved from   http://mydoctor.kaiserpermanente.org/ncal/mdo/
  7. Hart, R.G. et al. (2012). Intracranial hemorrhage in atrial fibrillation patients during anticoagulation with warfarin or dabigatran: the RE-LY trial. Stroke, 43(6): 1511–1517. Retrieved from  http://www.ncbi.nlm.nih.gov/pubmed/22492518
  8. U.S. Food and Drug Administration. (2012). Medication guide: Pradaxa. Retrieved from  http://www.fda.gov/downloads/Drugs/DrugSafety/UCM231720.pdf
  9. Bankhead, C. (2012, February 29). Bleeding risk with blood thinner cited. MedPage Today. Retrieved from  http://www.medpagetoday.com/Cardiology/Arrhythmias/31427
  10. Harper, P. et al. (2012). Bleeding risk with dabigatran in the frail elderly. New England Journal of Medicine, 366: 864–866. Retrieved from  http://www.nejm.org/doi/full/10.1056/NEJMc1112874
  11. Silverman, E. (2012, November 6). Was the FDA safety analysis for a popular bloodthinner flawed? Forbes. Retrieved from  http://www.forbes.com/sites/edsilverman/2012/11/06/was-the-fda-safety-analysis-for-a-popular-bloodthinner-flawed/
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