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Pradaxa

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Pradaxa

Pradaxa

Pradaxa Side Effects Center

Pharmacy Editor: Melissa Conrad Stöppler, MD

Pradaxa (dabigatran) is an anticoagulant that works by the clotting protein thrombin. Dabigatran is used to prevent blood clots from forming because of a certain irregular heart rhythm (atrial fibrillation). Preventing these blood clots helps to reduce the risk of a stroke. It is administered in capsule form. Side effects can include bruising and minor bleeding, nausea, and abdominal or stomach pain.

There are no adequate and well-controlled studies of Pradaxa in pregnant women. It is not known whether dabigatran is excreted in human milk. The safety and effectiveness of Pradaxa in pediatric patients has also not been established.

Our Pradaxa Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Pradaxa in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using dabigatran and call your doctor at once if you have a serious side effect such as:

  • any bleeding that will not stop;
  • weakness, feeling like you might pass out;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • blood in your urine or stools, black or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • pink or brown urine;
  • joint pain or swelling; or
  • heavy menstrual bleeding.

Less serious side effects may include:

  • stomach pain or upset, indigestion, heartburn;
  • nausea, diarrhea; or
  • mild skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Pradaxa (Dabigatran Etexilate Mesylate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Pradaxa Overview - Patient Information: Side Effects

SIDE EFFECTS: Easy bruising or minor bleeding (such as nosebleed, bleeding from cuts) may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can cause serious bleeding if it affects your blood clotting proteins too much. Tell your doctor right away if you have any signs of serious bleeding, including: unusual pain/swelling/discomfort, unusual/easy bruising, prolonged bleeding from cuts or gums, persistent/frequent nosebleeds, unusually heavy/prolonged menstrual flow, pink/dark urine, coughing up blood, vomit that is bloody or looks like coffee grounds, severe headache, dizziness/fainting, unusual or persistent tiredness/weakness, bloody/black/tarry stools.

Tell your doctor right away if you have any of these serious side effects: stomach/abdominal pain, severe heartburn/nausea/vomiting.

Get medical help right away if any of these rare but very serious signs of bleeding occur: vision changes, confusion, slurred speech, weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Pradaxa (Dabigatran Etexilate Mesylate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Pradaxa FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

The RE-LY (Randomized Evaluation of Long-term Anticoagulant Therapy) study provided safety information on the use of two doses of PRADAXA and warfarin [see Clinical Studies]. The numbers of patients and their exposures are described in Table 1. Limited information is presented on the 110 mg dosing arm because this dose is not approved.

Table 1 : Summary of Treatment Exposure in RE-LY

  PRADAXA 110 mg twice daily PRADAXA 150 mg twice daily Warfarin
Total number treated 5983 6059 5998
Exposure
   > 12 months 4936 4939 5193
   > 24 months 2387 2405 2470
Mean exposure (months) 20.5 20.3 21.3
Total patient-years 10,242 10,261 10,659

Drug Discontinuation In RE-LY

The rates of adverse reactions leading to treatment discontinuation were 21% for PRADAXA 150 mg and 16% for warfarin. The most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding and gastrointestinal events (i.e., dyspepsia, nausea, upper abdominal pain, gastrointestinal hemorrhage, and diarrhea).

Bleeding

[see WARNINGS AND PRECAUTIONS]

Table 2 shows the number of patients experiencing serious bleeding during the treatment period in the RE-LY study, with the bleeding rate per 100 patient-years (%). Major bleeds fulfilled one or more of the following criteria: bleeding associated with a reduction in hemoglobin of at least 2 grams per deciliter or leading to a transfusion of at least 2 units of blood, or symptomatic bleeding in a critical area or organ (intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding, or pericardial bleeding). A life-threatening bleed met one or more of the following criteria: fatal, symptomatic intracranial bleed, reduction in hemoglobin of at least 5 grams per deciliter, transfusion of at least 4 units of blood, associated with hypotension requiring the use of intravenous inotropic agents, or necessitating surgical intervention. Intracranial hemorrhage included intracerebral (hemorrhagic stroke), subarachnoid, and subdural bleeds.

Table 2 : Bleeding Events* (per 100 Patient-Years)

  PRADAXA 150 mg twice daily N (%) Warfarin N (%) Hazard Ratio (95% CI**)
Randomized patients 6076 6022  
Patient-years 12,033 11,794  
  Intracranial hemorrhage 38 (0.3) 90 (0.8) 0.41 (0.28, 0.60)
  Life-threatening bleed 179 (1.5) 218 (1.9) 0.80 (0.66, 0.98)
  Major bleed 399 (3.3) 421 (3.6) 0.93 (0.81, 1.07)
  Any bleed 1993 (16.6) 2166 (18.4) 0.91 (0.85, 0.96)
*Patients contributed multiple events and events were counted in multiple categories.
**Confidence interval

The risk of major bleeds was similar with PRADAXA 150 mg and warfarin across major subgroups defined by baseline characteristics, with the exception of age, where there was a trend towards a higher incidence of major bleeding on PRADAXA (hazard ratio 1.2, 95% CI: 1.0 to 1.4) for patients ≥ 75 years of age.

There was a higher rate of major gastrointestinal bleeds in patients receiving PRADAXA 150 mg than in patients receiving warfarin (1.6% vs. 1.1%, respectively, with a hazard ratio vs. warfarin of 1.5, 95% CI, 1.2 to 1.9), and a higher rate of any gastrointestinal bleeds (6.1% vs. 4.0%, respectively).

Gastrointestinal Adverse Reactions

Patients on PRADAXA 150 mg had an increased incidence of gastrointestinal adverse reactions (35% vs. 24% on warfarin). These were commonly dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and gastrointestinal ulcer).

Hypersensitivity Reactions

In the RE-LY study, drug hypersensitivity (including urticaria, rash, and pruritus), allergic edema, anaphylactic reaction, and anaphylactic shock were reported in < 0.1% of patients receiving PRADAXA.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of PRADAXA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post approval use of PRADAXA: angioedema, thrombocytopenia, esophageal ulcer.

Read the entire FDA prescribing information for Pradaxa (Dabigatran Etexilate Mesylate) »

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Pradaxa - User Reviews

Pradaxa User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Pradaxa sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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