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

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

Stop using dabigatran and call your doctor at once if you have:

• 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.

Common 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.

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.

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).

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.

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