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Pradaxa Side Effects

Generic name: dabigatran

Medically reviewed by Drugs.com. Last updated on Apr 25, 2022.

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.

For the Consumer

Applies to dabigatran: oral capsule

Warning

Oral route (Capsule; Pellet)

Premature Discontinuation Increases The Risk Of Thrombotic EventsPremature discontinuation of any oral anticoagulant, including dabigatran etexilate, increases the risk of thrombotic events. If anticoagulation with dabigatran etexilate is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.Spinal/Epidural HematomaEpidural or spinal hematomas may occur in patients treated with dabigatran etexilate who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters; concomitant use of other drugs that affect hemostasis, such as NSAIDs, platelet inhibitors, other anticoagulants; a history of traumatic or repeated epidural or spinal punctures; a history of spinal deformity or spinal surgery; optimal timing between administration of dabigatran etexilate and neuraxial procedures is not known. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the risks and benefits before neuraxial intervention in patients anticoagulated or to be anticoagulated.

Side effects requiring immediate medical attention

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

Rare

  • Chest pain, discomfort, or tightness
  • cough
  • difficulty with swallowing
  • dizziness
  • fainting or loss of consciousness
  • fast or irregular breathing
  • pain or discomfort in the arms, jaw, back, or neck
  • 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
  • sweating
  • trouble breathing
  • unusual tiredness or weakness

Incidence not known

  • Bleeding gums
  • blood in the urine
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • pinpoint red spots on the skin
  • unusual bleeding or bruising

Side effects not requiring immediate medical attention

Some side effects of dabigatran may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

For Healthcare Professionals

Applies to dabigatran: oral capsule

General

Bleeding is the most serious side effect reported with dabigatran (the active ingredient contained in Pradaxa) 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, alopecia[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: Agranulocytosis, neutropenia[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%): Epistaxis (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 (2010):

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.