Dabigatran Side Effects

Some side effects of dabigatran may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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
  • 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

Hematologic

Hematologic side effects have included intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intraarticular bleeding, or pericardial bleeding. Intracranial hemorrhage included intracerebral (hemorrhagic stroke), subarachnoid, and subdural bleeds. Postmarketing adverse reactions include thrombocytopenia.

Gastrointestinal

Gastrointestinal side effects have included nausea, diarrhea, 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). Postmarketing side effects include esophageal ulcers.

Hypersensitivity

Hypersensitivity side effects have included urticaria, rash, and pruritus, allergic edema, anaphylactic reaction, and anaphylactic shock. Postmarketing adverse reactions reported include angioedema.

Dermatologic

Dermatologic side effects have included rash, both pruritic and nonpruritic.

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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