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Pradaxa Side Effects

Generic Name: dabigatran

Medically reviewed by Last updated on July 14, 2020.

Note: This document contains side effect information about dabigatran. Some of the dosage forms listed on this page may not apply to the brand name Pradaxa.

For the Consumer

Applies to dabigatran: oral capsule


Oral route (Capsule)

Premature discontinuation of dabigatran etexilate mesylate increases the risk of thrombotic events. If anticoagulation with dabigatran etexilate mesylate must be discontinued for other than pathological bleeding, consider another anticoagulant. Epidural or spinal hematomas may occur with dabigatran etexilate mesylate therapy in patients undergoing neuraxial anesthesia or spinal puncture. Monitor patients for neurological impairment and treat urgently.

Side effects requiring immediate medical attention

Along with its needed effects, dabigatran (the active ingredient contained in Pradaxa) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dabigatran:

More common


  • Chest pain or discomfort
  • cough
  • difficulty with swallowing
  • dizziness
  • fainting or loss of consciousness
  • fast or irregular breathing
  • pain or discomfort in the arms, jaw, back or neck
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • skin rash, hives, welts, or itching skin
  • sweating
  • tightness in the chest
  • trouble breathing
  • unusual tiredness or weakness

Incidence not known

  • Bleeding gums
  • blood in the urine
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • pinpoint red spots on the skin
  • unusual bleeding or bruising

Side effects not requiring immediate medical attention

Some side effects of dabigatran may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

For Healthcare Professionals

Applies to dabigatran: oral capsule


Bleeding is the most serious side effect reported with dabigatran (the active ingredient contained in Pradaxa) Major or severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes.[Ref]


Major bleeds have occurred in critical areas or organs such as, intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal, intra-articular, or pericardial.[Ref]

Very common (10% or more): Bleeding up to 16.5%

Uncommon (0.1% to 1%): Hematoma, hemorrhage[Ref]


Very common (10% or more): Dyspepsia: upper abdominal pain, abdominal discomfort, epigastric discomfort; gastritis like symptoms, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and gastrointestinal ulcer

Common (1% to 10%): Diarrhea, nausea

Uncommon (0.1% to 1%): rectal hemorrhage, hemorrhoidal hemorrhage, vomiting, dysphagia

Postmarketing reports: Esophageal ulcer[Ref]


Common (1% to 10%): Skin hemorrhage

Postmarketing reports: Angioedema, alopecia[Ref]


Common (1% to 10%): Anemia

Uncommon (0.1% to 1%): Hemoglobin decreased, thrombocytopenia, occult blood positive

Rare (less than 0.1%): Hematocrit decreased

Postmarketing reports: Agranulocytosis, neutropenia[Ref]


Common (1% to 10%): Wound secretion (5%)

Rare (less than 0.1%): Traumatic hemorrhage[Ref]


Common (1% to 10%): Urogenital hemorrhage (including hematuria 1.2%)

Uncommon (0.1% to 1%): Positive blood urine tests[Ref]


Common (1% to 10%): Epistaxis (0.6% to 0.7%)

Uncommon (0.1% to 1%): Hemoptysis[Ref]


Uncommon (0.1% to 1%): Abnormal hepatic function/liver function test, ALT increased, AST increased, hepatic enzyme increased

Rare (less than 0.1%): Hyperbilirubinemia, transaminases increased[Ref]


Uncommon (0.1% to 1%): Urticaria, rash, pruritus, allergic edema, anaphylactic reaction, anaphylactic shock

Frequency not reported: Bronchospasm[Ref]


Uncommon (0.1% to 1%): Hemarthrosis[Ref]

Nervous system

Uncommon (0.1% to 1%): Intracranial hemorrhage

Frequency not reported: Intracerebral hemorrhage (Hemorrhagic stroke), subarachnoid and subdural bleeds[Ref]


Rare (less than 0.1%): Injection site hemorrhage, catheter site hemorrhage, incision site hemorrhage[Ref]


1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Pradaxa (dabigatran)." Boehringer-Ingelheim, Ridgefield, CT.

4. To K, Reynolds C, Spinler SA "Rash associated with dabigatran etexilate." Pharmacotherapy 33 (2013): e23-7

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.