Using Pradaxa - Contraindications

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A full list of contraindications for Pradaxa is shown below – patients meeting any of these criteria should NOT be given Pradaxa:1

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the Pradaxa Summary of Product Characteristics.
  • Patients with severe renal impairment (CrCL <30 mL/min) (see section 4.2 of the Pradaxa Summary of Product Characteristics).
  • Active clinical significant bleeding
  • Lesion or condition, if considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
  • Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, rivaroxaban, apixaban, etc.) except under specific circumstances of switching anticoagulant therapy (see section 4.2 of the Pradaxa Summary of Product Characteristics) or when UFH is given at doses necessary to maintain an open central venous or arterial catheter (see section 4.5 of the Pradaxa Summary of Product Characteristics)
  • Hepatic impairment or liver disease expected to have any impact on survival
  • Concomitant treatment with systemic ketoconazole, cyclosporine, itraconazole and dronedarone (see section 4.5 of the Pradaxa Summary of Product Characteristics)
  • Prosthetic heart valves requiring anticoagulant treatment (see section 5.1 of the Pradaxa Summary of Product Characteristics)
References: 
  1. Pradaxa Summary of Product Characteristics 2016. Boehringer Ingelheim.