Pradaxa Side Effects
Generic Name: dabigatran
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.
Some side effects of Pradaxa 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 (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
- Acid or sour stomach
- black, tarry stools
- bloody stools
- pain or burning in the throat
- stomach discomfort, upset, burning, or pain
- vomiting of blood or material that looks like coffee grounds
- difficulty with swallowing
- fainting or loss of consciousness
- fast heartbeat
- fast or irregular breathing
- hives or welts
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- redness of the skin
- shortness of breath
- skin rash
- tightness in the chest
- trouble with breathing
- unusual tiredness or weakness
- 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 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 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 side effects have included urticaria, rash, and pruritus, allergic edema, anaphylactic reaction, and anaphylactic shock. Postmarketing adverse reactions reported include angioedema.
Dermatologic side effects have included rash, both pruritic and nonpruritic.
More about Pradaxa (dabigatran)
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