Dabigatran Side Effects

Not all side effects for dabigatran may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to dabigatran: oral capsule

In addition to its needed effects, some unwanted effects may be caused by dabigatran. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking dabigatran:

More common
  • Acid or sour stomach
  • belching
  • black, tarry stools
  • bloody stools
  • constipation
  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • pain or burning in the throat
  • stomach discomfort, upset, burning, or pain
  • vomiting
  • vomiting of blood or material that looks like coffee grounds
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.

Cardiovascular

Very common (10% or more): Bleeding up to 16.5%
Uncommon (0.1% to 1%): Hematoma, hemorrhage

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

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

Dermatologic

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

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

Other

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

Renal

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

Respiratory

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

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

Hypersensitivity

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

Musculoskeletal

Uncommon (0.1% to 1%): Hemarthrosis

Nervous system

Uncommon (0.1% to 1%): Intracranial hemorrhage
Frequency not reported: Intracerebral hemorrhage (Hemorrhagic stroke), subarachnoid and subdural bleeds

Local

Rare (less than 0.1%): Injection site hemorrhage, catheter side hemorrhage, incision side hemorrhage

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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