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Dabigatran Side Effects

For the Consumer

Applies to dabigatran: oral capsule

Along with its needed effects, dabigatran 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 Rare
  • Cough
  • difficulty with swallowing
  • dizziness
  • fainting or loss of consciousness
  • fast heartbeat
  • fast or irregular breathing
  • 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
  • tightness in the chest
  • trouble breathing
  • unusual tiredness or weakness
Incidence not known
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

For Healthcare Professionals

Applies to dabigatran: oral capsule

General

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

Cardiovascular

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]

Gastrointestinal

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]

Dermatologic

Common (1% to 10%): Skin hemorrhage
Postmarketing reports: Angioedema[Ref]

Hematologic

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: Thrombocytopenia[Ref]

Other

Common (1% to 10%): Wound secretion (5%)
Rare (less than 0.1%): Traumatic hemorrhage[Ref]

Renal

Common (1% to 10%): Urogenital hemorrhage (including hematuria 1.2%)
Uncommon (0.1% to 1%): Positive blood urine tests[Ref]

Respiratory

Common (1% to 10%): Epitaxis (0.6% to 0.7%)
Uncommon (0.1% to 1%): Hemoptysis[Ref]

Hepatic

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]

Hypersensitivity

Uncommon (0.1% to 1%): Urticaria, rash, pruritus, allergic edema, anaphylactic reaction, anaphylactic shock
Frequency not reported: Bronchospasm[Ref]

Musculoskeletal

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]

Local

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

References

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.

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