dabigatran (Rx)

Brand and Other Names:Pradaxa
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsule

  • 75mg
  • 110mg
  • 150mg

Stroke Prophylaxis With Atrial Fibrillation

Prevention of stroke and systemic embolism associated with nonvalvular atrial fibrillation

CrCl >30 mL/min: 150 mg PO BID

CrCl 15-30 mL/min: 75 mg PO BID

CrCl <15 mL/min or dialysis: No data available; not recommended

Dosage modifications (atrial fibrillation)

  • Renal impairment and coadministration with P-gp inhibitors
    • CrCl 30-50 mL/min and coadministration with dronedarone or systemic ketoconazole: Reduce dose to 75 mg BID (dose adjustment is not necessary when coadministered with other P-gp inhibitors)
    • CrCl <30 mL/min with concomitant use of any P-gp inhibitor: Avoid coadministration

AHA/ACC/HRS guidelines for atrial fibrillation

  • Class 1: For patients with AF or atrial flutter <48-hour duration and with high risk of stroke, IV heparin or LMWH, or administration of a factor Xa or direct thrombin inhibitor, is recommended as soon as possible before or immediately after cardioversion, followed by long-term anticoagulation therapy
  • Class IIa: For patients with AF or atrial flutter of ≥48-hr, or when the duration of AF is unknown, anticoagulation with warfarin (INR 2-3), a factor Xa inhibitor, or direct thrombin inhibitor is recommended for at least 3 weeks prior to and 4 weeks after cardioversion
  • Class IIb: For patients with AF or atrial flutter <48-hour duration who are at low thromboembolic risk, anticoagulation (IV heparin, LMWH, or a new oral anticoagulant) or no antithrombotic therapy may be considered for cardioversion, without the need for postcardioversion oral anticoagulation
  • For patients with nonvalvular AF unable to maintain a therapeutic INR level with warfarin, use of a direct thrombin or factor Xa inhibitor
  • Not recommended in patients with AF and end-stage CKD or on hemodialysis because of the lack of evidence from clinical trials regarding the balance of risks and benefits; warfarin or apixaban recommended
  • Circulation July 9, 2019

DVT or PE Treatment

Indicated for treatment of deep vein thrombosis (DVT) and pulmonary embolus (PE) in patients who have been treated with a parenteral anticoagulant for 5-10 days

Also indicated to reduce the risk of recurrence of DVT and PE in patients who have been previously treated

CrCl >30 mL/min: 150 mg PO BID

CrCl ≤30 mL/min or on dialysis: Dosage recommendations cannot be provided

CrCl <50 mL/min with concomitant use of P-gp inhibitors: Avoid coadministration

DVT or PE Prophylaxis

Indicated for the prophylaxis of DVT and PE following hip replacement surgery

CrCl >30 mL/min: 110 mg PO 1-4 hr after surgery and after hemostasis has been achieved on first day, then 220 mg taken qDay for 28-35 days

If dabigatran is not started on the day of surgery, after hemostasis has been achieved initiate treatment with 220 mg qDay

CrCl ≤30 mL/min or on dialysis: Dosing recommendations cannot be provided

CrCl <50 mL/min with concomitant use of P-gp inhibitors: Avoid coadministration

Dosing Considerations

Different dosage forms

  • Available in different dosage forms (ie, capsules for adults or children aged 8 to <18 years, oral pellets for children aged 3 months to <12 years) and not all dosage forms are approved for the same indications and age groups
  • Additionally, there are differences between dosage forms with respect to dosing owing different bioavailability
  • Do not substitute different dosage forms (for example, capsules) for oral pellets on a milligram-to-milligram basis and do not combine more than 1 dosage form to achieve the total dose

Converting to dabigatran from warfarin or parenteral anticoagulants

  • Converting from warfarin: Discontinue warfarin and initiate dabigatran when INR <2.0
  • Converting from parenteral anticoagulant: Give dabigatran 0-2 hours before time for next dose of the parenteral drug that was to have been administered or initiate at time of discontinuing continuous IV heparin

Converting from dabigatran to warfarin or parenteral anticoagulants

  • CrCl ≥50 mL/min: Start warfarin 3 days before discontinuing dabigatran
  • CrCl 30-50 mL/min: Start warfarin 2 days before discontinuing dabigatran
  • CrCl 15-30 mL/min: Start warfarin 1 day before discontinuing dabigatran
  • CrCl <15 mL/min: No recommendations can be made
  • Converting to parenteral anticoagulant: Wait 12 hours (CrCl ≥30 mL/min) or 24 hours (CrCl <30 mL/min) after last dabigatran dose before initiating parenteral anticoagulant

Discontinuation for surgery and other interventions

  • If possible, discontinue dabigatran 1 to 2 days (CrCl ≥50 mL/min) or 3 to 5 days (CrCl <50 mL/min) before invasive or surgical procedures because of the increased risk of bleeding
  • Consider longer times for patients undergoing major surgery, spinal puncture, or placement of a spinal or epidural catheter or port, in whom complete hemostasis may be required
  • If surgery cannot be delayed, there is increased risk of bleeding; this risk of bleeding should be weighed against urgency of intervention; use a specific reversal agent (idarucizumab) in case of emergency surgery or urgent procedures when reversal of anticoagulant effect of dabigatran is needed; refer to idarucizumab prescribing information for additional information
  • Restart dabigatran capsules as soon as medically appropriate

Dosage Forms & Strengths

capsule

  • 75mg, 110mg, 150mg

oral pellets

  • 20mg, 30mg, 40mg
  • 50mg, 110mg, 150mg

VTE Treatment or Prevention

Indicated for treatment of venous thromboembolic events (VTE) in pediatric patients aged >3 months to <18 years who have been treated with a parenteral anticoagulant for at least 5 days

Also indicated to reduce risk of recurrent VTEs in pediatric patients aged 3 months to <18 years who have been previously treated

<3 months: Safety and efficacy not established

3 months to <2 years (oral pellets)

  • Adjust dose according to age and actual weight as treatment progresses
  • 3 to <4 kg (3 to <6 months): 30 mg PO BID
  • 4 to <5 kg (3 to <10 months): 40 mg PO BID
  • 5 to <7 kg (3 to <5 months): 40 mg PO BID
  • 5 to <7 kg (5 to <24 months): 50 mg PO BID
  • 7 kg to <9 kg (3 to <4 months): 50 mg PO BID
  • 7 kg to <9 kg (4 to <9 months): 60 mg PO BID
  • 7 kg to <9 kg (9 to <24 months): 70 mg PO BID
  • 9 kg to <11 kg (5 to <6 months): 60 mg PO BID
  • 9 kg to <11 kg (6 to <11 months): 80 mg PO BID
  • 9 kg to <11 kg (11 to <24 months): 90 mg PO BID
  • 11 to <13 kg (8 to <18 months): 100 mg PO BID
  • 11 to <13 kg (18 to <24 months): 110 mg PO BID
  • 13 to <16 kg (10 to <11 months): 100 mg PO BID
  • 13 to <16 kg (11 to <24 months): 140 mg PO BID
  • 16 kg to <21 kg (12 to <24 months): 140 mg PO BID
  • 21 kg to <26 kg (18 to <24 months): 180 mg PO BID

2 to <12 years (oral pellets)

  • 7 to <9 kg: 70 mg PO BID
  • 9 to <11 kg: 90 mg PO BID
  • 11 to <13 kg: 110 mg PO BID
  • 13 to <16 kg: 140 mg PO BID
  • 16 to <21 kg: 170 mg PO BID
  • 21 to <41 kg: 220 mg PO BID
  • >41 kg: 260 mg PO BID

8 to <18 years (capsules)

  • May use for older children or adolescents who can swallow the capsule whole
  • Dosage based on actual weight
  • 11 to <16 kg: 75 mg PO BID
  • 16 to <26 kg: 110 mg PO BID
  • 26 to <41 kg: 150 mg PO BID
  • 41 to <61 kg: 185 mg PO BID
  • 61 to <81 kg: 220 mg PO BID
  • >81 kg: 260 mg PO BID

Dosage Modifications

Renal impairment (pellets or capsules)

  • eGFR >50 mL/min/1.73 m2: No dosage adjustment required
  • eGFR <50 mL/min/1.73 m2: Avoid use owing to lack of pediatric data

Dosing Considerations

Different dosage forms

  • Available in different dosage forms (ie, capsules for adults or children aged 8 to <18 years, oral pellets for children aged 3 months to <12 years) and not all dosage forms are approved for the same indications and age groups
  • Additionally, there are differences between dosage forms with respect to dosing owing different bioavailability
  • Do not substitute different dosage forms (for example, capsules) for oral pellets on a milligram-to-milligram basis and do not combine more than 1 dosage form to achieve the total dose

Converting to dabigatran from warfarin or parenteral anticoagulants

  • Converting from warfarin: Discontinue warfarin and initiate dabigatran when INR <2.0
  • Converting from parenteral anticoagulant: Give dabigatran 0-2 hours before time for next dose of the parenteral drug that was to have been administered or initiate at time of discontinuing continuous IV heparin

Converting from dabigatran to warfarin or parenteral anticoagulants

  • eGFR ≥50 mL/min/1.73 m2: Start warfarin 3 days before discontinuing dabigatran capsules
  • eGFR <50 mL/min/1.73 m2: Not studied; avoid dabigatran capsules/pellets in these patients
  • Wait 12 hr after last dose of oral pellets or capsule before switching to parenteral anticoagulant

Discontinuation for surgery and other interventions

  • Discontinue dabigatran pellets/capsules 24 hr before an elective surgery (eGFR >80 mL/min/1.73 m2) or 2 days before an elective surgery (eGFR 50-80 mL/min/1.73 m2)
  • Pediatric patients with an eGFR <50 mL/min/1.73 m2 have not been studied; avoid use of dabigatran pellets/ capsules in these patients

Increases risk of bleeding; bleeding can be significant and sometimes fatal; risk for bleeding or stroke increases with age >75 years

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Interactions

Interaction Checker

and dabigatran

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            Contraindicated (3)

            • defibrotide

              defibrotide increases effects of dabigatran by pharmacodynamic synergism. Contraindicated. Coadministration of defibrotide is contraindicated with antithrombotic/fibrinolytic drugs. This does not include use for routine maintenance or reopening of central venous lines.

            • mifepristone

              mifepristone, dabigatran. Other (see comment). Contraindicated. Comment: Mifepristone may lead to excessive post abortion bleeding in pts. on anticoagulant therapy.

            • prothrombin complex concentrate, human

              dabigatran, prothrombin complex concentrate, human. pharmacodynamic synergism. Contraindicated.

            Serious - Use Alternative (30)

            • antithrombin alfa

              antithrombin alfa and dabigatran both increase anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • antithrombin III

              antithrombin III and dabigatran both increase anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • apixaban

              dabigatran and apixaban both increase anticoagulation. Avoid or Use Alternate Drug.

            • carbamazepine

              carbamazepine decreases levels of dabigatran by increasing metabolism. Avoid or Use Alternate Drug. The concomitant use of dabigatran and P-gp inducers should generally be avoided.

              carbamazepine will decrease the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration. P-gp inducers reduce systemic exposure of dabigatran

            • dalteparin

              dabigatran and dalteparin both increase anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • doxorubicin liposomal

              doxorubicin liposomal will decrease the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration. P-gp inducers reduce systemic exposure of dabigatran

            • dronedarone

              dronedarone will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Atrial fibrillation: Decrease dabigatran dose when coadministered with dronedarone if CrCl is 30-50 mL/min. Avoid coadministering dabigatran with dronedarone if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with dronedarone if CrCl <50 mL/min

            • edoxaban

              edoxaban, dabigatran. Either increases toxicity of the other by anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding, monitor closely. Promptly evaluate any signs or symptoms of blood loss. Long-term concomitant treatment with edoxaban and other anticoagulants is not recommended. Short-term coadministration may be needed for patients transitioning to or from edoxaban.

            • enoxaparin

              dabigatran and enoxaparin both increase anticoagulation. Avoid or Use Alternate Drug. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • erdafitinib

              erdafitinib will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If coadministration unavoidable, separate administration by at least 6 hr before or after administration of P-gp substrates with narrow therapeutic index.

            • fondaparinux

              dabigatran and fondaparinux both increase anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • fosphenytoin

              fosphenytoin will decrease the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration. P-gp inducers reduce systemic exposure of dabigatran

            • heparin

              dabigatran and heparin both increase anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • ivacaftor

              ivacaftor increases levels of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min.

            • ketoconazole

              ketoconazole will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Atrial fibrillation: Decrease dabigatran dose when coadministered with ketoconazole if CrCl is 30-50 mL/min. Avoid coadministering dabigatran with ketoconazole if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with ketoconazole if CrCl <50 mL/min

            • lasmiditan

              lasmiditan increases levels of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

            • nefazodone

              nefazodone will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.

            • phenobarbital

              phenobarbital will decrease the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration. P-gp inducers reduce systemic exposure of dabigatran

            • phenytoin

              phenytoin will decrease the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration. P-gp inducers reduce systemic exposure of dabigatran

            • primidone

              primidone will decrease the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration. P-gp inducers reduce systemic exposure of dabigatran

            • rifampin

              rifampin will decrease the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration. P-gp inducers reduce systemic exposure of dabigatran

            • sotorasib

              sotorasib will decrease the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.

            • St John's Wort

              St John's Wort will decrease the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration. P-gp inducers reduce systemic exposure of dabigatran

            • tenofovir DF

              tenofovir DF will decrease the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration. P-gp inducers reduce systemic exposure of dabigatran

            • tepotinib

              tepotinib will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.

            • tipranavir

              tipranavir increases effects of dabigatran by pharmacodynamic synergism. Avoid or Use Alternate Drug. Tipranavir has mild antiplatelet activity that may incr bleeding risk. The concomitant use of dabigatran and P-gp inducers should generally be avoided. .

              tipranavir will decrease the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration. P-gp inducers reduce systemic exposure of dabigatran

            • vinblastine

              vinblastine will decrease the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration. P-gp inducers reduce systemic exposure of dabigatran

            • vortioxetine

              vortioxetine and dabigatran both increase anticoagulation. Avoid or Use Alternate Drug.

            • warfarin

              dabigatran and warfarin both increase anticoagulation. Avoid or Use Alternate Drug. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • zanubrutinib

              dabigatran, zanubrutinib. Either increases effects of the other by anticoagulation. Avoid or Use Alternate Drug.

            Monitor Closely (156)

            • abciximab

              dabigatran, abciximab. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • abiraterone

              abiraterone will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • acalabrutinib

              acalabrutinib increases effects of dabigatran by anticoagulation. Use Caution/Monitor. Coadministration of acalabrutinib with antiplatelets or anticoagulants may further increase risk of hemorrhage. Monitor for signs of bleeding and consider the benefit-risk of withholding acalabrutinib for 3-7 days presurgery and postsurgery depending upon the type of surgery and the risk of bleeding.

            • afatinib

              afatinib will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • agrimony

              dabigatran and agrimony both increase anticoagulation. Modify Therapy/Monitor Closely.

            • alfalfa

              dabigatran and alfalfa both increase anticoagulation. Modify Therapy/Monitor Closely.

            • alteplase

              dabigatran and alteplase both increase anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • American ginseng

              dabigatran and American ginseng both increase anticoagulation. Modify Therapy/Monitor Closely.

            • amiodarone

              amiodarone will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • anagrelide

              dabigatran, anagrelide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • anamu

              dabigatran and anamu both increase anticoagulation. Use Caution/Monitor.

            • argatroban

              argatroban and dabigatran both increase anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • aspirin

              dabigatran and aspirin both increase anticoagulation. Modify Therapy/Monitor Closely. Both drugs have the potential to cause bleeding. The need for simultaneous use of low-dose aspirin (<100 mg/day) with anticoagulants are common for patients with cardiovascular disease, but may result in increased bleeding; monitor closely. Promptly evaluate any signs or symptoms of blood loss if treated concomitantly with low-dose aspirin. Avoid coadministration with chronic use of higher dose aspirin

            • aspirin rectal

              dabigatran and aspirin rectal both increase anticoagulation. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • aspirin/citric acid/sodium bicarbonate

              dabigatran and aspirin/citric acid/sodium bicarbonate both increase anticoagulation. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • atorvastatin

              atorvastatin will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • azficel-T

              azficel-T, dabigatran. Other (see comment). Use Caution/Monitor. Comment: Coadministration with anticoagulants or antiplatelets may increase bruising or bleeding at biopsy and/or injection sites; concomitant use not recommended. Decisions regarding continued use or cessation of anticoagulants or antiplatelets should be made by a physician.

            • azithromycin

              azithromycin will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • berotralstat

              berotralstat will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.

            • betrixaban

              dabigatran, betrixaban. Either increases levels of the other by anticoagulation. Use Caution/Monitor.

            • bivalirudin

              bivalirudin and dabigatran both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • caplacizumab

              caplacizumab, dabigatran. Either increases effects of the other by anticoagulation. Use Caution/Monitor.

            • carvedilol

              carvedilol will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • celecoxib

              dabigatran and celecoxib both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • chitosan

              chitosan increases effects of dabigatran by Other (see comment). Use Caution/Monitor. Comment: Chitosan can decrease GI absorption of vitamin K, enhancing anticoagulant effects.

            • choline magnesium trisalicylate

              dabigatran and choline magnesium trisalicylate both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • cilostazol

              dabigatran, cilostazol. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • cinnamon

              dabigatran and cinnamon both increase anticoagulation. Modify Therapy/Monitor Closely.

            • citalopram

              citalopram increases effects of dabigatran by pharmacodynamic synergism. Use Caution/Monitor. Combination may increase risk of bleeding.

            • clarithromycin

              clarithromycin will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • clopidogrel

              dabigatran, clopidogrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • cobicistat

              cobicistat will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • collagenase clostridium histolyticum

              dabigatran increases toxicity of collagenase clostridium histolyticum by anticoagulation. Use Caution/Monitor. Collagenase clostridium histolyticum has high incidence of ecchymosis/contusion at injection site; avoid concomitant anticoagulants (except for low-dose aspirin, ie, up to 150 mg/day).

            • cordyceps

              dabigatran and cordyceps both increase anticoagulation. Modify Therapy/Monitor Closely.

            • cornsilk

              cornsilk decreases effects of dabigatran by pharmacodynamic antagonism. Use Caution/Monitor. Cornsilk contains vitamin K; consume a consistent amount daily.

            • crizotinib

              crizotinib will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • cyclosporine

              cyclosporine will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • danshen

              dabigatran and danshen both increase anticoagulation. Use Caution/Monitor.

            • darunavir

              darunavir will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. P-gp inhibitors may increase systemic exposure of dabigatran in patients with renal impairment.

            • deferasirox

              deferasirox, dabigatran. Other (see comment). Use Caution/Monitor. Comment: Gastric ulceration and GI bleeding have been reported in patients taking deferasirox, use caution when coadministering with other drugs known to increase the risk of peptic ulcers or gastric hemorrhage including anticoagulants.

            • desirudin

              dabigatran and desirudin both increase anticoagulation. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • devil's claw

              dabigatran and devil's claw both increase anticoagulation. Use Caution/Monitor.

            • diclofenac

              dabigatran and diclofenac both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • diflunisal

              dabigatran and diflunisal both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

              diflunisal increases effects of dabigatran by plasma protein binding competition. Use Caution/Monitor.

            • dipyridamole

              dabigatran, dipyridamole. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

              dipyridamole will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • dong quai

              dabigatran and dong quai both increase anticoagulation. Modify Therapy/Monitor Closely.

            • elagolix

              elagolix will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • eliglustat

              eliglustat will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              elvitegravir/cobicistat/emtricitabine/tenofovir DF will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • epoprostenol

              dabigatran and epoprostenol both increase anticoagulation. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • eptifibatide

              dabigatran, eptifibatide. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • erythromycin base

              erythromycin base will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • erythromycin lactobionate

              erythromycin lactobionate will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • erythromycin stearate

              erythromycin stearate will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • ethanol

              ethanol increases effects of dabigatran by unknown mechanism. Use Caution/Monitor. Acute EtOH intoxication.

            • ethotoin

              dabigatran increases levels of ethotoin by unknown mechanism. Use Caution/Monitor.

              ethotoin, dabigatran. Other (see comment). Use Caution/Monitor. Comment: Hydantoin anticonvulsants increase anticoagulant effects at first, then decrease those effects with continued use (2+ wks). There are multiple mechanisms involved, including enzyme induction, plasma protein binding site competition, and additive effects on prothrombin time.

            • etodolac

              dabigatran and etodolac both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • etravirine

              etravirine will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • fennel

              dabigatran and fennel both increase anticoagulation. Modify Therapy/Monitor Closely.

            • fenoprofen

              dabigatran and fenoprofen both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • feverfew

              dabigatran and feverfew both increase anticoagulation. Modify Therapy/Monitor Closely.

            • fish oil

              fish oil, dabigatran. Other (see comment). Use Caution/Monitor. Comment: Patients taking fish oil and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding. .

            • fish oil triglycerides

              fish oil triglycerides will increase the level or effect of dabigatran by anticoagulation. Use Caution/Monitor. Prolonged bleeding reported in patients taking antiplatelet agents or anticoagulants and oral omega-3 fatty acids. Periodically monitor bleeding time in patients receiving fish oil triglycerides and concomitant antiplatelet agents or anticoagulants.

            • fluorouracil

              fluorouracil increases effects of dabigatran by unspecified interaction mechanism. Use Caution/Monitor. Due to the thrombocytopenic effects of fluorouracil additive risk of bleeding may be seen in patients receiving concomitant anticoagulants.

            • flurbiprofen

              dabigatran and flurbiprofen both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • forskolin

              dabigatran and forskolin both increase anticoagulation. Modify Therapy/Monitor Closely.

            • fostamatinib

              fostamatinib will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of P-gp substrates. Monitor for toxicities of the P-gp substrate drug that may require dosage reduction when given concurrently with fostamatinib.

            • garlic

              dabigatran and garlic both increase anticoagulation. Modify Therapy/Monitor Closely.

            • ginger

              dabigatran and ginger both increase anticoagulation. Modify Therapy/Monitor Closely.

            • ginkgo biloba

              dabigatran and ginkgo biloba both increase anticoagulation. Modify Therapy/Monitor Closely.

            • glecaprevir/pibrentasvir

              glecaprevir/pibrentasvir will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.

            • grapefruit

              grapefruit will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • green tea

              green tea, dabigatran. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of bleeding, caution is advised.

            • hemin

              dabigatran, hemin. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Hemin degradation product (ie, hematin) may produce coagulopathy (eg, thrombocytopenia, platelet degranulation) and cause mild anticoagulant effects.

            • horse chestnut seed

              dabigatran and horse chestnut seed both increase anticoagulation. Modify Therapy/Monitor Closely.

            • ibrutinib

              ibrutinib will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

              ibrutinib will increase the level or effect of dabigatran by anticoagulation. Use Caution/Monitor. Ibrutinib may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies and monitor for signs of bleeding.

            • ibuprofen

              dabigatran and ibuprofen both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • ibuprofen IV

              dabigatran and ibuprofen IV both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • icosapent

              icosapent, dabigatran. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Icosapent may prolong bleeding time; monitor periodically if coadministered with other drugs that affect bleeding.

            • iloprost

              dabigatran and iloprost both increase anticoagulation. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • imatinib

              imatinib, dabigatran. Either increases toxicity of the other by Other (see comment). Modify Therapy/Monitor Closely. Comment: Imatinib may cause thrombocytopenia; bleeding risk increased when imatinib is coadministered with anticoagulants, NSAIDs, platelet inhibitors, and thrombolytic agents; patients requiring anticoagulation while on imatinib should receive LMWH or unfractionated heparin instead of warfarin because of multiple interaction mechanisms of imatinib with warfarin.

            • indomethacin

              dabigatran and indomethacin both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • istradefylline

              istradefylline will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.

            • itraconazole

              itraconazole will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • ketoprofen

              dabigatran and ketoprofen both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • ketorolac

              dabigatran and ketorolac both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • ketorolac intranasal

              dabigatran and ketorolac intranasal both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • lapatinib

              lapatinib will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • ledipasvir/sofosbuvir

              ledipasvir/sofosbuvir will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • lomitapide

              lomitapide will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • lonafarnib

              lonafarnib will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.

            • lopinavir

              lopinavir will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • meclofenamate

              dabigatran and meclofenamate both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • mefenamic acid

              dabigatran and mefenamic acid both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • mefloquine

              mefloquine will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • melatonin

              melatonin increases effects of dabigatran by anticoagulation. Use Caution/Monitor. Melatonin may decrease prothrombin time.

            • meloxicam

              dabigatran and meloxicam both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • mistletoe

              dabigatran increases and mistletoe decreases anticoagulation. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

            • nabumetone

              dabigatran and nabumetone both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • naproxen

              dabigatran and naproxen both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • nelfinavir

              nelfinavir will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • neratinib

              neratinib increases levels of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Neratinib inhibits P-gp transport. Caution if coadministered with a P-gp substrate with a narrow therapeutic index.

            • nettle

              dabigatran increases and nettle decreases anticoagulation. Effect of interaction is not clear, use caution. Modify Therapy/Monitor Closely.

            • nicardipine

              nicardipine will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • nifedipine

              nifedipine will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • nilotinib

              nilotinib will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • nintedanib

              nintedanib increases effects of dabigatran by anticoagulation. Use Caution/Monitor. Nintedanib is a VEGFR inhibitor, and may increase the risk of bleeding; monitor patients on full anticoagulation therapy; monitor closely for bleeding and adjust therapy as needed .

            • omega 3 carboxylic acids

              omega 3 carboxylic acids, dabigatran. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3 acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

            • omega 3 fatty acids

              omega 3 fatty acids, dabigatran. Other (see comment). Use Caution/Monitor. Comment: Patients taking omega-3-fatty acids and an anticoagulant or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding. .

            • oxaprozin

              dabigatran and oxaprozin both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • paliperidone

              paliperidone will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • panax ginseng

              dabigatran and panax ginseng both increase anticoagulation. Modify Therapy/Monitor Closely.

            • pau d'arco

              dabigatran and pau d'arco both increase anticoagulation. Modify Therapy/Monitor Closely.

            • pegaspargase

              pegaspargase increases effects of dabigatran by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of bleeding events.

            • pentosan polysulfate sodium

              dabigatran and pentosan polysulfate sodium both increase anticoagulation. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • piroxicam

              dabigatran and piroxicam both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • ponatinib

              ponatinib will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • porfimer

              dabigatran decreases effects of porfimer by pharmacodynamic antagonism. Use Caution/Monitor.

            • posaconazole

              posaconazole will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • prasugrel

              dabigatran, prasugrel. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • progesterone micronized

              progesterone micronized will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • propafenone

              propafenone will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • propranolol

              propranolol will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • quinidine

              quinidine will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • quinine

              quinine will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • ranolazine

              ranolazine will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • reishi

              dabigatran and reishi both increase anticoagulation. Modify Therapy/Monitor Closely.

            • reteplase

              dabigatran and reteplase both increase anticoagulation. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • rifabutin

              rifabutin decreases levels of dabigatran by increasing metabolism. Use Caution/Monitor. The concomitant use of dabigatran and P-gp inducers should generally be avoided.

            • ritonavir

              ritonavir will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • rivaroxaban

              rivaroxaban, dabigatran. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Avoid concurrent use of rivaroxaban with other anticoagulants due to increased bleeding risk other than during therapeutic transition periods where patients should be observed closely. Monitor for signs/symptoms of blood loss.

            • salsalate

              dabigatran and salsalate both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • saquinavir

              saquinavir will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • sarecycline

              sarecycline will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.

            • saw palmetto

              saw palmetto increases toxicity of dabigatran by unspecified interaction mechanism. Use Caution/Monitor. May increase risk of bleeding.

            • Siberian ginseng

              dabigatran and Siberian ginseng both increase anticoagulation. Modify Therapy/Monitor Closely.

            • sodium zirconium cyclosilicate

              sodium zirconium cyclosilicate will decrease the level or effect of dabigatran by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Separate administration by at least 2 hr.

            • stiripentol

              stiripentol will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.

            • sulindac

              dabigatran and sulindac both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • sunitinib

              sunitinib will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • suvorexant

              suvorexant will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • tacrolimus

              tacrolimus will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • tamoxifen

              tamoxifen will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • tenecteplase

              dabigatran and tenecteplase both increase anticoagulation. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • ticagrelor

              ticagrelor, dabigatran. Either increases effects of the other by anticoagulation. Use Caution/Monitor. According to official packaging labeling, dose adjustment of oral dabigatran not required when coadministered with oral dose of ticagrelor.

              ticagrelor will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • ticlopidine

              dabigatran, ticlopidine. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • tirofiban

              dabigatran, tirofiban. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • tolmetin

              dabigatran and tolmetin both increase anticoagulation. Use Caution/Monitor. Caution is advised, both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • treprostinil

              dabigatran and treprostinil both increase anticoagulation. Use Caution/Monitor. Both drugs have the potential to cause bleeding. Concomitant use may increase risk of bleeding.

            • tucatinib

              tucatinib will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.

            • ulipristal

              ulipristal will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • vandetanib

              vandetanib will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • vemurafenib

              vemurafenib will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • verapamil

              verapamil will increase the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Atrial fibrillation: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <30 mL/min. DVT/PE treatment: Avoid coadministering dabigatran with P-gp inhibitors if CrCl <50 mL/min

            • vorapaxar

              dabigatran, vorapaxar. Either increases effects of the other by anticoagulation. Use Caution/Monitor. Coadministration of anticoagulants, antiplatelets, or other drug affecting coagulation should be monitored periodically due to potential increased risk of bleeding.

            Minor (3)

            • chlorella

              chlorella decreases effects of dabigatran by pharmacodynamic antagonism. Minor/Significance Unknown. Theoretical, due to vitamin K content.

            • mineral oil

              mineral oil decreases levels of dabigatran by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.

            • verteporfin

              dabigatran decreases effects of verteporfin by pharmacodynamic antagonism. Minor/Significance Unknown.

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            Adverse Effects

            >10%

            Adults

            • Dyspepsia and gastritis (35%; compared with warfarin [24%])
            • Any bleed (16.6%; compared with warfarin [18.4%])

            Pediatrics

            • GI adverse effects (32%; compared with standard of care [SOC] with warfarin, LMWH, or fondaparinux [12%])
            • Any bleeding (22%; SOC 24%)
            • Minor bleeding (19%; SOC 23%)

            1-10%

            Adults

            • Major bleed (3.47%/y; compared with warfarin [3.58%/y])
            • GI bleed (1.59%/y; compared with warfarin [1.51%/y])

            Pediatrics

            • Major and clinically relevant nonmajor bleeding (3.4%; SOC 3.3%)
            • Major bleeding (2.3%; SOC 2.2%)
            • Clinically relevant nonmajor bleeding (1.1%; SOC 1.1%)

            <1%

            Adults

            • Intracranial hemorrhage (0.22%/y; compared with warfarin [0.77%/y])
            • Hypersensitivity, including urticaria, rash, pruritus (<0.1%)

            Postmarketing Reports

            Adults

            • Angioedema
            • Neutropenia
            • Agranulocytosis
            • Esophageal ulcers
            • Thrombocytopenia
            • Alopecia
            • Vomiting
            • Nausea
            • Diarrhea
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            Warnings

            Black Box Warnings

            Premature discontinuation

            • Premature discontinuation of any oral anticoagulant, including dabigatran, increases the risk of thrombotic events
            • If dabigatran must be discontinued for a reason other than pathological bleeding, consider coverage with another anticoagulant

            Spinal/epidural hematoma

            • Epidural or spinal hematomas may occur in patients who are receiving neuraxial anesthesia or undergoing spinal puncture
            • These hematomas may result in long-term or permanent paralysis
            • Monitor patients frequently for signs and symptoms of neurological impairment; if neurological compromise is noted, urgent treatment is necessary
            • Consider the benefits and risks before neuraxial intervention in patients who are anticoagulated or to be anticoagulated
            • Factors that can increase risk include:
              • Indwelling epidural catheters
              • Coadministration with other drugs that affect hemostasis (eg, NSAIDs, platelet inhibitors, other anticoagulants)
              • History of traumatic or repeated epidural or spinal punctures
              • History of spinal deformity or spinal surgery
              • Optimal timing is unknown between dabigatran administration and neuraxial procedures

            Contraindications

            Hypersensitivity to drug or excipients

            Active pathologic bleeding

            Mechanical prosthetic heart valves

            • Significantly more thromboembolic events (eg, valve thrombosis, stroke, TIAs, MI) observed with dabigatran than with warfarin
            • Excessive major bleeding (predominantly postoperative pericardial effusions requiring intervention for hemodynamic compromise) observed with dabigatran, compared with warfarin
            • These bleeding and thromboembolic events, seen in the RE-ALIGN study (Am Heart J, June 2012), were observed in patients who were started on dabigatran postoperatively within 3 days after mechanical bileaflet valve implantation, as well as in patients whose valves had been implanted more than 3 months prior to enrollment in the study; this clinical trial was terminated early because of these events

            Cautions

            Premature discontinuation of oral anticoagulants (other than pathological bleeding) in the absence of adequate alternative anticoagulation increases risk of thrombotic events

            Direct-acting oral anticoagulants (DOACs) not recommended for use in patients with triple-positive antiphospholipid syndrome (APS); for patients with APS (especially those who are triple-positive [positive for lupus anticoagulant, anticardiolipin, and anti-beta 2-glycoprotein I antibodies]), treatment with DOACs has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy

            Spinal/epidural anesthesia or puncture

            • When neuraxial anesthesia (spinal/epidural anesthesia) or spinal puncture is employed, patients treated with anticoagulant agents are at risk of developing an epidural or spinal hematoma which can result in long-term or permanent paralysis
            • Consider dabigatran pharmacokinetic profile; placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known

            Coadministration with P-gp inducers and inhibitors

            • P-gp inducers (eg, rifampin) reduce exposure to dabigatran and should generally be avoided
            • P-gp inhibition and impaired renal function are the major independent factors that result in increased exposure to dabigatran
            • Concomitant use of P-gp inhibitors in patients with renal impairment is expected to produce increased exposure of dabigatran compared to that seen with either factor alone
            • Concomitant use of dabigatran capsules with P-gp-inhibitors has not been studied in pediatric patients but may increase exposure to dabigatran
            • DVT/PE treatment/prevention, renal impairment, and P-gp inhibitors: Avoid coadministration if CrCl <50 mL/min
            • VTE in pediatric patients: Not studied, but P-gp inhibitors may increase dabigatran exposure
            • AF treatment, renal impairment, and P-gp inhibitors
              • CrCl 30-50 mL/min and P-gp inhibitors dronedarone or ketoconazole: Consider reducing the dose (see Dosage Modifications)
              • CrCl 30-50 mL/min: Use of the P-gp inhibitors verapamil, amiodarone, quinidine, clarithromycin, and ticagrelor does not require a dose adjustment, however, these results should not be extrapolated to other P-gp inhibitors
              • CrCl <30 mL/min: Avoid coadministration with all P-gp inhibitors

            Reversing anticoagulant effect

            • Idarucizumab is commercially available for reversal of the anticoagulant effect of dabigatran in adults for surgery/urgent procedures, or life-threatening or uncontrolled bleeding
            • Can be dialyzed (protein binding is low, with the removal of about 60% of drug over 2-3 hr); however, the amount of data supporting this approach is limited
            • Activated prothrombin complex concentrates, recombinant factor VIIa, or concentrates of coagulation factors II, IX, or X may be considered, but their use has not been evaluated in clinical trials
            • Protamine sulfate and vitamin K are not expected to affect the anticoagulant activity of dabigatran
            • Consider administration of platelet concentrates in cases in which thrombocytopenia is present or long-acting antiplatelet drugs have been used
            • Efficacy and safety of idarucizumab not established in pediatric patients
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            Pregnancy & Lactation

            Pregnancy

            Limited available data on use in pregnant females are insufficient to determine drug-associated risks for adverse developmental outcomes; there are risks to mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in mother and fetus associated with use of anticoagulants

            Clinical considerations

            • Pregnancy confers an increased risk for thromboembolism that is higher for females with underlying thromboembolic disease and certain high-risk pregnancy conditions; published data describe that women with previous history of venous thrombosis are at high risk for recurrence during pregnancy
            • Use of anticoagulants, may increase risk of bleeding in fetus and neonate; monitor neonates for bleeding

            Labor or delivery

            • All patients receiving anticoagulants, including pregnant women, are at risk for bleeding; use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas; consider discontinuation or use of shorter acting anticoagulant as delivery approaches

            Females of reproductive potential

            • Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician
            • The risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants should be assessed in females of reproductive potential and those with abnormal uterine bleeding

            Lactation

            There are no data on presence of dabigatran in human milk, effects on breastfed child, or on milk production; drug and/or its metabolites were present in rat milk; breastfeeding is not recommended during therapy

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Prevents thrombus development through direct, competitive inhibition of thrombin (thrombin enables fibrinogen conversion to fibrin during the coagulation cascade)

            Inhibits free and clot-bound thrombin and thrombin-induced platelet aggregation

            Absorption

            Peak plasma time: 1 hr (fasting); ~2 hr (high-fat meal)

            Bioavailability

            • Intact oral capsule: 3-7%; oral bioavailability increases by 75% when pellets are taken without the capsule shell
            • Oral pellets: 37% higher relative bioavailability in healthy adults compared to dabigatran capsules
            • Relative bioavailability between the 2 dosage forms is age dependent; relative bioavailability observed in adults cannot be translated to pediatric patients

            Distribution

            Protein bound: 35%

            Vd: 50-70 L

            Metabolism

            Prodrug dabigatran etexilate is converted to dabigatran

            Substrate of efflux transporter P-gp

            Not a substrate, inhibitor, or inducer of CYP450 enzymes

            Elimination

            Half-life

            • Pellets: 9-11 hr
            • Capsule
              • Normal renal function: 12-17 hr
              • Mild to moderate renal impairment: 14-17 hr
              • Severe renal impairment: 28 hr

            Renal clerance: 80% of total clearance after IV administration

            Excretion: 7% urine; 86% feces

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            Administration

            Oral Pellet Preparation

            Administer only with specific soft foods or apple juice

            Soft food preparation

            • Mix with 2 teaspoons of following foods at room temperature
            • Baby rice cereal prepared with water
            • Mashed carrots
            • Applesauce
            • Mashed banana

            Oral Administration

            Oral capsules

            • For adults and children aged 8 years to <18 years
            • Swallow capsule whole (do not chew, crush, or break); do not open capsules and empty the pellets from the capsule
            • Missed dose
              • If dose missed, take as soon as possible on same day
              • Skip missed dose if unable to take at least 6 hr before next scheduled dose; do not double dose to make up for a missed dose

            Oral pellets

            • For pediatric patients aged 3 months to <12 years as soon as they are able to swallow soft food
            • Administered twice daily, 1 dose in the morning and 1 dose in the evening, at approximately the same time every day; dosing interval should be as close to 12 hr as possible
            • Give prepared medication before meals to ensure patient takes the full dose
            • Administer immediately after mixing or within 30 minutes after mixing; discard if not administered within 30 minutes of mixing and prepare a new dose
            • Administration with apple juice: Spoon oral pellets directly into patient’s mouth and swallow with apple juice or added to ~1-2 ounces of apple juice for drinking
            • Do not administer pellets
              • Via syringes or feeding tubes
              • With milk, milk products, or soft foods containing mild products
            • Missed or partial dose
              • If dose missed, take as soon as possible on the same day
              • Skip missed dose if unable to take at least 6 hr before next scheduled dose; do not double dose to make up for a missed dose
              • If partial dose taken, do not administer a second dose at that time; administer next dose as scheduled ~12 hr later

            Storage

            Store at room temperature of 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

            Capsules: Store in original container; once bottle is opened, capsules are stable for only 4 months

            Pellets: Store in original package to protect from moisture; do not open the packets until ready for use; use within 6 months of opening the aluminum bag containing the packets

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Pradaxa oral
            -
            150 mg capsule
            Pradaxa oral
            -
            75 mg capsule
            Pradaxa oral
            -
            110 mg capsule

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            dabigatran etexilate oral

            DABIGATRAN - ORAL

            (DA-bi-GAT-ran)

            COMMON BRAND NAME(S): Pradaxa

            WARNING: Do not stop taking dabigatran unless directed by your doctor. If you stop taking this medication early, you have a higher risk of forming a serious blood clot (such as a stroke, blood clot in the legs/lungs). Your doctor may direct you to take a different "blood thinning" or antiplatelet medication to reduce your risk. Get medical help right away if you have weakness on one side of the body, trouble speaking, sudden vision changes, confusion, chest pain, trouble breathing, pain/warmth/swelling in the legs.People taking this medication may bleed near the spinal cord after certain spinal procedures. Bleeding in this area can cause paralysis that lasts a long time or could become permanent. Ask your doctor about the benefits and risks before any spinal procedure. The risk of bleeding may be higher if you have a deformed spine, or have had spinal procedures/surgery before (such as epidural catheter placement, difficult epidural/spinal puncture), or are taking other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin/enoxaparin, nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). Tell your doctor right away if you notice symptoms such as back pain, leg numbness/tingling/weakness, loss of control of the bowels or bladder (incontinence).

            USES: Dabigatran is used to prevent stroke and harmful blood clots (such as in your legs or lungs) if you have a certain type of irregular heartbeat (atrial fibrillation). Dabigatran is also used to treat blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism) and to reduce the risk of them occurring again. This medication may also be used to prevent these blood clots from forming after hip replacement surgery. Dabigatran is an anticoagulant that works by blocking a certain substance (a clotting protein called thrombin) in your blood. This helps to keep blood flowing smoothly in your body.Dabigatran should not be used to prevent blood clots from forming after artificial heart valve replacement. If you have had heart valve surgery, talk to your doctor about the best medication for you. Do not stop taking any medication, including dabigatran, without talking to your doctor first.

            HOW TO USE: See also Warning section.Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking dabigatran and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually twice a day. Children should take the first dose in the morning and the second dose in the evening (about 12 hours apart). To prevent clots after hip or knee replacement surgery, take it as directed by your doctor, usually once a day. Avoid antacids within 24 hours after surgery, or dabigatran may not work as well. If you have stomach upset while taking this medication, take it with food.Swallow the capsules whole with a full glass of water (8 ounces/240 milliliters). Do not crush, chew, or break open the capsules. Doing so can release all of the drug at once, increasing the risk of side effects. Do not put this medication in a pill box or medication reminder box. It must be kept tightly closed in the original bottle (or blister package) to protect it from moisture. See also Storage section for more important details.The dosage is based on your medical condition, kidney function, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). For children, the dosage is also based on age and weight.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.It is very important to take it exactly as directed. Do not increase your dose or take this drug more often than directed. Do not stop taking this medication without consulting your doctor.

            SIDE EFFECTS: See also Warning section.Easy bruising, minor bleeding (such as nosebleed, bleeding from cuts), upset stomach, or heartburn may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication can cause serious bleeding if it affects your blood clotting proteins too much. Tell your doctor right away if you have any signs of serious bleeding, including: unusual pain/swelling/discomfort, unusual/easy bruising, prolonged bleeding from cuts or gums, persistent/frequent nosebleeds, unusually heavy/prolonged menstrual flow, pink/dark urine, coughing up blood, vomit that is bloody or looks like coffee grounds, severe headache, dizziness/fainting, unusual or persistent tiredness/weakness, bloody/black/tarry stools.Tell your doctor right away if you have any serious side effects, including: stomach/abdominal pain, severe heartburn/nausea/vomiting, unusual fatigue, dark urine, yellowing eyes/skin.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking dabigatran, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: mechanical heart valve, kidney disease, bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), blood disorders (such as anemia, hemophilia, thrombocytopenia), liver disease, recent major injury/surgery, stroke, a certain clotting disorder (antiphospholipid syndrome), frequent falls/injuries.It is important that all your doctors and dentists know that you take dabigatran. Before having surgery or any medical/dental procedures, tell your doctor or dentist that you are taking this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor may tell you to stop this medication before surgery. Follow your doctor's directions carefully.Avoid getting injections into the muscles. If you must have an injection into the muscle (for example, a flu shot), ask for it to be given in the arm. This way, it will be easier to check for bleeding and/or apply pressure bandages.This medication may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Ask your doctor or pharmacist about how much alcohol you may safely drink.This medication can cause heavy bleeding. To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Use an electric razor when shaving and a soft toothbrush when brushing your teeth. If you fall or injure yourself, especially if you hit your head, call your doctor right away. Your doctor may need to check you.Older adults may be at greater risk for bleeding while using this drug.During pregnancy, this medication should be used only when clearly needed. Dabigatran may increase the risk of bleeding in the pregnant woman, the unborn baby, and the newborn baby. Discuss the risks and benefits with your doctor. Your doctor may change the type of medication you use during pregnancy.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: See also Warning section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: mifepristone.Other medications can affect the removal of dabigatran from your body, which may affect how dabigatran works. Examples include cobicistat, cyclosporine, dronedarone, ketoconazole, rifampin, and St. John's wort, among others.Aspirin, aspirin-like drugs (salicylates), and nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, naproxen, celecoxib) may have effects similar to dabigatran. These drugs may increase the risk of bleeding problems if taken during treatment with dabigatran. Carefully check all prescription/nonprescription product labels (including drugs applied to the skin such as pain-relieving creams) since the products may contain NSAIDs or salicylates. Talk to your doctor about using a different medication (such as acetaminophen) to treat pain/fever. If you have been prescribed low-dose aspirin and related drugs (such as clopidogrel, ticlopidine) for specific medical reasons such as heart attack or stroke prevention, ask your doctor if you should continue taking them or if your prescription should be changed. Consult your doctor or pharmacist for more details.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: bloody/black/tarry stools, pink/dark urine, unusual/prolonged bleeding.

            NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as kidney/liver function, clotting times) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is less than 6 hours until the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: See also How To Use section.Store at room temperature away from light and moisture. Do not store in the bathroom. Keep this medication in the original bottle. Do not put this medication in a pill box or medication reminder box. Open only one bottle at a time, and once the bottle is opened, the medication must be thrown away after 4 months. If your capsules are in a blister package, then keep the capsules in the blister package until you are ready to take the medication. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

            Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.