- SIDE EFFECTS
- Clinical Trials Experience
- Reduction Of Risk Of Stroke And Systemic Embolism In Non-valvular Atrial Fibrillation
- Drug Discontinuation In RE-LY
- Gastrointestinal Adverse Reactions
- Hypersensitivity Reactions
- Treatment And Reduction In The Risk Of Recurrence Of Deep Venous Thrombosis And Pulmonary Embolism
- Prophylaxis Of Deep Vein Thrombosis And Pulmonary Embolism Following Hip Replacement Surgery
- Postmarketing Experience
- SIDE EFFECTS
- dabigatran (Pradaxa)
- Internal Bleeding Caused by Pradaxa
- Pradaxa Linked to Heart Attacks
- Get Legal Help if You Have Pradaxa Side Effects
- Blood Thinner Drugs and Alcohol: A Dangerous Mix?
- Warfarin Interactions With Alcohol
- Types of Drug Interactions With Alcohol
- Further information
- What is dabigatran?
- How to take dabigatran
- Special instructions
- Precautions – before taking dabigatran
- Possible side effects
- Learn more
- How does this medication work? What will it do for me?
- What form(s) does this medication come in?
- How should I use this medication?
- Who should NOT take this medication?
- What side effects are possible with this medication?
- Are there any other precautions or warnings for this medication?
- What other drugs could interact with this medication?
- Patient Education Blog
The following serious adverse reactions are described elsewhere in the labeling:
- Increased Risk of Thrombotic Events after Premature Discontinuation
- Risk of Bleeding
- Spinal/Epidural Anesthesia or Puncture
- Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves
- The most serious adverse reactions reported with PRADAXA were related to bleeding .
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Reduction Of Risk Of Stroke And Systemic Embolism In Non-valvular Atrial Fibrillation
The RE-LY (Randomized Evaluation of Long-term Anticoagulant Therapy) study provided safety information on the use of two doses of PRADAXA and warfarin . The numbers of patients and their exposures are described in Table 1. Limited information is presented on the 110 mg dosing arm because this dose is not approved.
Table 1 : Summary of Treatment Exposure in RE-LY
|PRADAXA 110 mg twice daily||PRADAXA 150 mg twice daily||Warfarin|
|Total number treated||5983||6059||5998|
|> 12 months||4936||4939||5193|
|> 24 months||2387||2405||2470|
|Mean exposure (months)||20.5||20.3||21.3|
Drug Discontinuation In RE-LY
The rates of adverse reactions leading to treatment discontinuation were 21% for PRADAXA 150 mg and 16% for warfarin. The most frequent adverse reactions leading to discontinuation of PRADAXA were bleeding and gastrointestinal events (i.e., dyspepsia, nausea, upper abdominal pain, gastrointestinal hemorrhage, and diarrhea).
Table 2 shows the number of adjudicated major bleeding events during the treatment period in the RE-LY study, with the bleeding rate per 100 subject-years (%). Major bleeding is defined as bleeding accompanied by one or more of the following: a decrease in hemoglobin of ≥2 g/dL, a transfusion of ≥2 units of packed red blood cells, bleeding at a critical site or with a fatal outcome. Intracranial hemorrhage included intracerebral (hemorrhagic stroke), subarachnoid, and subdural bleeds.
Table 2 : Adjudicated Major Bleeding Events in Treated Patientsa
There was a higher rate of any gastrointestinal bleeds in patients receiving PRADAXA 150 mg than in patients receiving warfarin (6.6% vs. 4.2%, respectively).
The risk of major bleeds was similar with PRADAXA 150 mg and warfarin across major subgroups defined by baseline characteristics (see Figure 1), with the exception of age, where there was a trend towards a higher incidence of major bleeding on PRADAXA (hazard ratio 1.2, 95% CI: 1.0 to 1.5) for patients ≥75 years of age.
Figure 1 : Adjudicated Major Bleeding by Baseline Characteristics Including Hemorrhagic Stroke Treated Patients
Note: The figure above presents effects in various subgroups all of which are baseline characteristics and all of which were pre-specified. The 95% confidence limits that are shown do not take into account how many comparisons were made, nor do they reflect the effect of a particular factor after adjustment for all other factors. Apparent homogeneity or heterogeneity among groups should not be over-interpreted.
Gastrointestinal Adverse Reactions
Patients on PRADAXA 150 mg had an increased incidence of gastrointestinal adverse reactions (35% vs. 24% on warfarin). These were commonly dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) and gastritis-like symptoms (including GERD, esophagitis, erosive gastritis, gastric hemorrhage, hemorrhagic gastritis, hemorrhagic erosive gastritis, and gastrointestinal ulcer).
In the RE-LY study, drug hypersensitivity (including urticaria, rash, and pruritus), allergic edema, anaphylactic reaction, and anaphylactic shock were reported in <0.1% of patients receiving PRADAXA.
Treatment And Reduction In The Risk Of Recurrence Of Deep Venous Thrombosis And Pulmonary Embolism
PRADAXA was studied in 4387 patients in 4 pivotal, parallel, randomized, double-blind trials. Three of these trials were active-controlled (warfarin) (RE-COVER, RE-COVER II, and RE-MEDY), and one study (RE-SONATE) was placebo-controlled. The demographic characteristics were similar among the 4 pivotal studies and between the treatment groups within these studies. Approximately 60% of the treated patients were male, with a mean age of 55.1 years. The majority of the patients were white (87.7%), 10.3% were Asian, and 1.9% were black with a mean CrCl of 105.6 mL/min.
Bleeding events for the 4 pivotal studies were classified as major bleeding events if at least one of the following criteria applied: fatal bleeding, symptomatic bleeding in a critical area or organ (intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding, or pericardial bleeding), bleeding causing a fall in hemoglobin level of 2.0 g/dL (1.24 mmol/L or more, or leading to transfusion of 2 or more units of whole blood or red cells).
RE-COVER and RE-COVER II studies compared PRADAXA 150 mg twice daily and warfarin for the treatment of deep vein thrombosis and pulmonary embolism. Patients received 5-10 days of an approved parenteral anticoagulant therapy followed by 6 months, with mean exposure of 164 days, of oral only treatment; warfarin was overlapped with parenteral therapy. Table 3 shows the number of patients experiencing bleeding events in the pooled analysis of RE-COVER and RE-COVER II studies during the full treatment including parenteral and oral only treatment periods after randomization.
Table 3 : Bleeding Events in RE-COVER and RE-COVER II Treated Patients
The rate of any gastrointestinal bleeds in patients receiving PRADAXA 150 mg in the full treatment period was 3.1% (2.4% on warfarin).
The RE-MEDY and RE-SONATE studies provided safety information on the use of PRADAXA for the reduction in the risk of recurrence of deep vein thrombosis and pulmonary embolism.
RE-MEDY was an active-controlled study (warfarin) in which 1430 patients received PRADAXA 150 mg twice daily following 3 to 12 months of oral anticoagulant regimen. Patients in the treatment studies who rolled over into the RE-MEDY study had a combined treatment duration of up to more than 3 years, with mean exposure of 473 days. Table 4 shows the number of patients experiencing bleeding events in the study.
Table 4 : Bleeding Events in RE-MEDY Treated Patients
In the RE-MEDY study, the rate of any gastrointestinal bleeds in patients receiving PRADAXA 150 mg was 3.1% (2.2% on warfarin).
RE-SONATE was a placebo-controlled study in which 684 patients received PRADAXA 150 mg twice daily following 6 to 18 months of oral anticoagulant regimen. Patients in the treatment studies who rolled over into the RE-SONATE study had combined treatment duration up to 9 months, with mean exposure of 165 days. Table 5 shows the number of patients experiencing bleeding events in the study.
Table 5 : Bleeding Events in RE-SONATE Treated Patients
In the RE-SONATE study, the rate of any gastrointestinal bleeds in patients receiving PRADAXA 150 mg was 0.7% (0.3% on placebo).
Clinical Myocardial Infarction Events
In the active-controlled VTE studies, a higher rate of clinical myocardial infarction was reported in patients who received PRADAXA than in those who received warfarin . In the placebo-controlled study, a similar rate of non-fatal and fatal clinical myocardial infarction was reported in patients who received PRADAXA and in those who received placebo .
In the four pivotal studies, patients on PRADAXA 150 mg had a similar incidence of gastrointestinal adverse reactions (24.7% vs. 22.7% on warfarin). Dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) occurred in patients on PRADAXA in 7.5% vs. 5.5% on warfarin, and gastritis-like symptoms (including gastritis, GERD, esophagitis, erosive gastritis and gastric hemorrhage) occurred at 3.0% vs. 1.7%, respectively.
In the 4 pivotal studies, drug hypersensitivity (including urticaria, rash, and pruritus), allergic edema, anaphylactic reaction, and anaphylactic shock were reported in 0.1% of patients receiving PRADAXA.
Prophylaxis Of Deep Vein Thrombosis And Pulmonary Embolism Following Hip Replacement Surgery
PRADAXA was studied in 5476 patients, randomized and treated in two double-blind, active-controlled non-inferiority trials (RE-NOVATE and RE-NOVATE II). The demographic characteristics were similar across the two studies and between the treatment groups within these studies. Approximately 45.3 % of the treated patients were male, with a mean age of 63.2 years. The majority of the patients were white (96.1%), 3.6% were Asian, and 0.3% were black with a mean CrCl of 92 mL/min.
Bleeding events for the RE-NOVATE and RE-NOVATE II studies were classified as major bleeding events if at least one of the following criteria applied: fatal bleeding, symptomatic bleeding in a critical area or organ (intraocular, intracranial, intraspinal or retroperitoneal bleeding), bleeding causing a fall in hemoglobin level of 2.0 g/dL (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells, requiring treatment cessation or leading to re-operation.
The RE-NOVATE study compared PRADAXA 75 mg taken orally 1-4 hours after surgery followed by 150 mg once daily, PRADAXA 110 mg taken orally 1-4 hours after surgery followed by 220 mg once daily and subcutaneous enoxaparin 40 mg once daily initiated the evening before surgery for the prophylaxis of deep vein thrombosis and pulmonary embolism in patients who had undergone hip replacement surgery. The RE-NOVATE II study compared PRADAXA 110 mg taken orally 1-4 hours after surgery followed by 220 mg once daily and subcutaneous enoxaparin 40 mg once daily initiated the evening before surgery for the prophylaxis of deep vein thrombosis and pulmonary embolism in patients who had undergone hip replacement surgery. In the RE-NOVATE and RE-NOVATE II studies, patients received 28-35 days of PRADAXA or enoxaparin with median exposure of 33 days. Tables 6 and 7 show the number of patients experiencing bleeding events in the analysis of RE-NOVATE and RE-NOVATE II.
Table 6 : Bleeding Events in RE-NOVATE Treated Patients
Table 7 : Bleeding Events in RE-NOVATE II Treated Patients
In the two studies, the rate of major gastrointestinal bleeds in patients receiving PRADAXA and enoxaparin was the same (0.1%) and for any gastrointestinal bleeds was 1.4% for PRADAXA 220 mg and 0.9% for enoxaparin.
In the two studies, the incidence of gastrointestinal adverse reactions for patients on PRADAXA 220 mg and enoxaparin was 39.5% and 39.5%, respectively. Dyspepsia (including abdominal pain upper, abdominal pain, abdominal discomfort, and epigastric discomfort) occurred in patients on PRADAXA 220 mg in 4.1% vs. 3.8% on enoxaparin, and gastritis-like symptoms (including gastritis, GERD, esophagitis, erosive gastritis and gastric hemorrhage) occurred at 0.6% vs. 1.0%, respectively.
In the two studies, drug hypersensitivity (such as urticaria, rash, and pruritus) was reported in 0.3% of patients receiving PRADAXA 220 mg.
In the two studies, clinical myocardial infarction was reported in 2 (0.1%) of patients who received PRADAXA 220 mg and 6 (0.3%) of patients who received enoxaparin.
The following adverse reactions have been identified during post approval use of PRADAXA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been identified during post approval use of PRADAXA: angioedema, thrombocytopenia, esophageal ulcer.
Read the entire FDA prescribing information for Pradaxa (Dabigatran Etexilate Mesylate)
What should I discuss with my healthcare provider before taking dabigatran (Pradaxa)?
You should not take dabigatran if you are allergic to it, or if you have:
- an artificial heart valve; or
- active bleeding from a surgery, injury, or other cause.
Dabigatran can cause a very serious blood clot around your spinal cord if you undergo a spinal tap or receive spinal anesthesia (epidural). This type of blood clot could cause long-term paralysis, and may be more likely to occur if:
- you have a genetic spinal defect;
- you have a spinal catheter in place;
- you have a history of spinal surgery or repeated spinal taps;
- you have recently had a spinal tap or epidural anesthesia;
- you are taking an NSAID–Advil, Aleve, Motrin, and others; or
- you are using other medicines to treat or prevent blood clots.
Dabigatran may cause you to bleed more easily, especially if:
- you have a stomach ulcer or bleeding in your stomach or intestines;
- you have kidney disease (especially if you also take dronedarone or ketoconazole);
- you take certain other medicines that can increase bleeding risk, such as aspirin, clopidogrel (Plavix), heparin, prasugrel, warfarin (Coumadin, Jantoven);
- you take an NSAID (nonsteroidal anti-inflammatory drug) on a regular basis, such as ibuprofen (Advil, Motrin), naproxen (Aleve), diclofenac, indomethacin, meloxicam, and others; or
- you are older than 75.
Tell your doctor if you have ever had:
- kidney disease;
- a bleeding disorder that is inherited or caused by disease;
- a stomach ulcer; or
- if you have been taking rifampin.
Tell your doctor if you are pregnant or if you become pregnant. Taking dabigatran during pregnancy may cause bleeding in the mother or the newborn baby. However, the risk of blood clots is higher during pregnancy. The benefit of preventing a blood clot may outweigh any risks to the baby.
You should not breast-feed while using dabigatran.
How should I take dabigatran (Pradaxa)?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Take this medicine with a full glass of water. You may take dabigatran with or without food.
Swallow the capsule whole and do not crush, chew, break, or open it.
Because dabigatran keeps your blood from coagulating (clotting) to prevent unwanted blood clots, this medicine can also make it easier for you to bleed, even from a minor injury such as a fall or a bump on the head. Contact your doctor or seek emergency medical attention if you fall or hit your head, or have any bleeding that will not stop.
If you need surgery, dental work, or any type of medical test or treatment, tell the doctor or dentist ahead of time if you have taken dabigatran within the past 12 hours.
Your kidney function may need to be checked before and during treatment with dabigatran.
Do not stop taking dabigatran without your doctor’s advice. Stopping the medication can increase your risk of stroke.
If you have received more than a 30-day supply of this medication, do not open more than one bottle at a time. Open a new bottle only after all the capsules in the old bottle are gone.
Store at room temperature, away from moisture and heat. Keep each capsule in the bottle or blister pack until you are ready to take the medicine.
Keep the capsules in their original container or blister pack. Do not put dabigatran capsules into a daily pill box or pill organizer.
Throw away any unused capsules if it has been longer than 4 months since you first opened the bottle. Capsules stored in a blister pack should be thrown away after the expiration date on the label has passed.
Heart Disease: Causes of a Heart Attack See Slideshow
The blood-thinning drug Pradaxa has been prescribed to reduce the risk of stroke in thousands of patients with atrial fibrillation, or an irregular heart rhythm.
Pradaxa (dabigatran etexilate mesylate) works by inhibiting an enzyme in the blood called “thrombin” that is involved in blood clotting. An irregular heartbeat increases the risk of developing blood clots, which can possibly cause a stroke.
However, soon after the U.S. Food and Drug Administration (FDA) approved Pradaxa for the U.S. market in 2010, the agency warned that the drug might cause serious uncontrollable bleeding in its users. Other studies suggest that Pradaxa can cause an increased risk of myocardial infarction (heart attack) or acute coronary syndrome.
Bloomberg News has reported that Pradaxa manufacturer Boehringer Ingelheim acknowledges that its drug has been linked to more than 250 deaths worldwide.
Internal Bleeding Caused by Pradaxa
It is understood that bleeding is a complication of blood-thinning medications, and it may lead to serious medical problems or even death. But since December 2011, the FDA has investigated whether patients who take Pradaxa suffer from uncontrollable internal bleeding more frequently than would be expected.
In November 2012, the FDA said it could not conclude that Pradaxa causes bleeding more often than warfarin, the next most commonly used anticoagulant. It advises that healthcare professionals who prescribe Pradaxa carefully follow dosing recommendations on the drug’s label, especially for patients with renal (kidney) impairment, to reduce the risk of bleeding.
The American Heart Association, meanwhile, explains that you are at a higher risk of suffering internal bleeding as a side effect of Pradaxa if:
- You have a history of bleeding
- You are older than 75 years of age
- You have kidney problems
- You have a stomach ulcer or other problems with stomach or intestinal bleeding
- You are taking other medications that also increase your risk of bleeding.
Internal bleeding is a serious matter. If you have any of these symptoms of internal bleeding, contact your doctor immediately:
- Severe or uncontrollable external bleeding
- Frequent nose bleeds
- Unusual bleeding from the gums
- Coughing up blood
- Vomiting blood or vomit that looks like coffee grounds
- Heavier than normal menstrual or vaginal bleeding
- Pink or brown urine
- Black or red stools
- Bruises that have no known cause or that grow larger
- Unexplainable pain, swelling, or joint pain
- Headaches with dizziness or weakness.
Pradaxa Linked to Heart Attacks
An article in the March 12, 2012, issue of the Archives of Internal Medicine says researchers from the Cleveland Clinic concluded that Pradaxa is associated with an increased risk of myocardial infarction (MI or heart attack) or acute coronary syndrome (ACS). “Acute coronary syndrome” is an umbrella term for situations where the blood supplied to the heart muscle is suddenly blocked.
Common signs of acute coronary syndrome include:
- Chest pain or discomfort, which may involve pressure, tightness or fullness
- Pain or discomfort in one or both arms, the jaw, neck, back or stomach
- Shortness of breath
- Feeling dizzy or lightheaded
Pradaxa may also cause many other side effects that require medical attention, according to the U.S. National Library of Medicine’s PubMed Health website.
Get Legal Help if You Have Pradaxa Side Effects
If you think you or a loved one of yours suffered uncontrollable or excessive bleeding, heart attack or acute coronary syndrome because they took Pradaxa, please contact Salvi, Schostok & Pritchard P.C., at our toll-free number or through our online form.
We are currently investigating cases of injuries and death believed to be attributable to Pradaxa. We can provide you with a free consultation to determine whether you may be eligible for compensation.
- FDA Drug Safety Communication about Pradaxa (dabigatran etexilate mesylate)
- PubMedHealth – Dabigatran
- Archives of Internal Medicine – Dabigatran Association With Higher Risk of Acute Coronary Events
Pradaxa is the brand name of the drug dabigatran, which is used to treat and prevent blood clots.
It’s also used to reduce the risk of stroke in people with a heart rhythm disorder known as atrial fibrillation.
The medicine is in a class of drugs called direct thrombin inhibitors. It works by keeping the coagulation factors in the blood from clotting.
Pradaxa was approved by the Food and Drug Administration (FDA) in 2010. It’s manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.
The FDA requires a black-box warning on Pradaxa because people with atrial fibrillation who take Pradaxa to prevent strokes or clots are at a higher risk of having a stroke after they stop taking the medicine.
Don’t stop taking Pradaxa without talking to your doctor. Continue to take this medication even if you feel well.
If you have an epidural, spinal anesthesia, or a spinal puncture while taking Pradaxa, you’re at a greater risk of developing a blood clot in or around your spine that could result in paralysis.
Tell your physician if you have an epidural catheter in your body or if you’ve ever had repeated epidurals, spinal punctures, a spinal deformity, or spinal surgery.
Also, it’s important to tell your doctor if you’re taking any of the following medicines:
Call your doctor immediately if you experience any of the following symptoms while taking Pradaxa:
- Muscle weakness (especially in the legs and feet)
- Back pain
- Numbness or tingling (especially in the legs)
- Loss of control of bowels or bladder
Pradaxa may make you more prone to bleeding, even from minor injuries. Avoid activities that increase your risk of bleeding.
You shouldn’t take Pradaxa if you have an artificial heart or if you’re experiencing bleeding from an injury, surgery, or other cause.
Before taking this medicine, tell your doctor if you have or have ever had:
- A bleeding problem or any blood disorder
- Bleeding or an ulcer in your stomach or intestine
- Kidney disease
- Liver disease
Also, tell your physician if you’re 75 years of age or older before taking this medicine.
Keep all appointments with your doctor and laboratory while taking Pradaxa. Your doctor will probably want to order certain tests to check your body’s response to the drug.
Tell your doctor you’re taking this medicine before having any type of surgery, including a dental procedure.
In 2014, the FDA completed a study comparing the risks of Pradaxa to those of another blood-thinning drug called warfarin.
The study included more than 134,000 Medicare patients who were 65 years of age or older.
The study showed Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death compared to warfarin.
However, the risk of having a heart attack was similar for both drugs.
Thousands of patients and their families filed lawsuits against Boehringer Ingelheim after reported instances of hemorrhaging and uncontrollable bleeding from Pradaxa.
In May 2014, the manufacturer of Pradaxa settled more than 4,000 lawsuits for $650 million.
This decision came despite the FDA study, which showed the drug posed a lower risk of stroke than warfarin.
Pregnancy and Pradaxa
It’s not known whether Pradaxa will harm an unborn baby.
Taking Pradaxa may increase your risk of severe bleeding during labor and delivery.
Tell your doctor if you’re pregnant or plan to become pregnant while taking this medicine.
It’s also not known whether the drug passes into breast milk and could harm a breastfeeding baby.
Talk to your doctor if you’re breastfeeding while taking Pradaxa.
Blood Thinner Drugs and Alcohol: A Dangerous Mix?
Medically reviewed by Leigh Ann Anderson, PharmD Last updated on Nov 8, 2019.
Warfarin Interactions With Alcohol
Warfarin (Coumadin) is a commonly used blood thinner (a coumarin oral anticoagulant). It is used to prevent or treat blood clots in veins, arteries, or the heart, which can reduce the risk of stroke, heart attack, or other serious conditions. It can also keep an existing clot from getting larger. Patients with a history of atrial fibrillation (AFib), peripheral artery disease (PAD), heart attack, or knee or hip surgeries at risk for venous thromboembolism (VTE) may use an anticoagulant.
- Combining alcohol and blood thinner medications such as warfarin can lead to drug interactions. Patients receiving warfarin should avoid acute alcohol intoxication, but the available information suggests modest alcohol intake (1 to 2 drinks/day) has little effect on warfarin response. It’s probably wise to avoid alcohol and warfarin until approved by your doctor. If you chronically drink alcohol or have active liver disease, alert your prescriber.
- Alcohol and warfarin side effects: When warfarin is combined with alcohol, the effects of warfarin can be altered and may lead to a greater risk of bleeding or a decreased warfarin effect. Liver disease may change these effects, too.
- Acutely drinking large amounts of alcohol (binge drinking) can decrease the metabolism (breakdown) of oral anticoagulants and increase the bleeding risk.
- On the other hand, excessive daily alcohol use increases the metabolism of warfarin and can lower its effectiveness, increasing the risk of a clot, a heart attack or stroke.
- The antiplatelet effect of alcohol may increase bleeding risk without effects on INR, a measure of warfarin effect. Platelets are important blood cells that help your body to form clots when bleeding. An antiplatelet effect can stop blood clots from forming.
- Call your doctor promptly if you have any unusual bleeding or bruising, vomiting, prolonged bleeding from cuts, increased menstrual flow, bleeding of gums from brushing your teeth, nosebleeds, blood in your urine or stools, black stools, headache, dizziness, or weakness.
The newer direct-acting oral anticoagulants (DOACs) do not have alcohol-drug interactions listed in their product labeling. However, if you consume large amounts of alcohol at one time or drink alcohol on a daily basis, be sure to discuss this with your doctor. Heavy alcohol use may increase the risk of a stomach ulcer or bleeding, and this can be worsened by an anticoagulant. In addition, some direct-acting oral anticoagulants are broken down in the liver; if you have alcohol-induced liver disease, tell your healthcare provider.
Table 1: Direct-acting oral anticoagulants
|Generic name||Brand example|
Types of Drug Interactions With Alcohol
- Acne Medicines and Alcohol Interactions
- ADHD Medications and Alcohol
- Allergies, Cough/Cold Medications and Alcohol
- Antibiotic Medications and Alcohol
- Antidepressant Medications and Alcohol Interactions
- Antipsychotic Medications and Alcohol
- Anxiety Medications and Alcohol
- Bipolar Medications and Alcohol
- Birth Control Medications and Alcohol
- Caffeine, Energy Drinks and Alcohol
- Can You Mix Weight Loss Drugs and Alcohol?
- Cholesterol Medications and Alcohol
- Diabetes Medications and Alcohol
- Enlarged Prostate (BPH) Medications and Alcohol Interactions
- Erectile Dysfunction Medications and Alcohol
- Heart Medications and Alcohol
- Herbal Supplements and Alcohol
- Illicit Drugs and Alcohol Interactions
- Motion Sickness Drugs and Alcohol Interactions
- Muscle Relaxants and Alcohol Interactions
- Pain / Fever Drugs and Alcohol Interactions
- Seizure Medications and Alcohol Interactions
- Sleep (Insomnia) Medications and Alcohol
- Stomach / Heartburn Medications and Alcohol
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Easy-to-read medicine information about dabigatran – what it is, how to take dabigatran safely and possible side effects.
|Type of medicine||Also called|
What is dabigatran?
Dabigatran is an anticoagulant or blood thinner. It slows down your body’s ability to clot blood. Dabigatran is used to prevent and treat blood clots. Preventing blood clots helps lower your risk of stroke, deep vein thrombosis (DVT) and pulmonary embolism (PE). You may be prescribed dabigatran:
- to prevent stroke if you have if you have atrial fibrillation (irregular heart beat) — atrial fibrillation increases your risk of stroke
- to treat deep vein thrombosis (DVT), which is from blood clots that form in your blood vessels, usually in the legs or arm. Read more about DVT
- to treat pulmonary embolism – which is from blood clots that form in the lungs. Read more about PE
- to prevent DVTs from forming again
- after hip or knee surgery when your risk of blood clots causing DVT or PE is increased.
Read more about anticoagulants.
- Dabigatran capsules are available in different strengths: 75 mg, 110 mg and 150 mg.
- Your doctor or pharmacist will tell you the strength that is right for you. Your dose of dabigatran will depend on what it is being used for.
|Dose of dabigatran|
|To prevent stroke in people with atrial fibrillation||150 mg two times a day|
|To prevent clots after knee or hip surgery||220 mg once daily|
|To treat blood clots||150 mg two times a day|
Always take your dabigatran exactly as your doctor has told you. The pharmacy label will tell you how much dabigatran to take, how often to take it and any special instructions.
How to take dabigatran
- Swallow the capsules whole with a full glass of water so the capsule doesn’t get stuck in your throat.
- Do not crush, chew or open the capsules. This will release all the medication at once and increase the risk of side effects.
- You can take dabigatran with or without food.
- Take dabigatran at the same times each day.
- Limit alcohol while you are taking dabigatran.
- If you forget to take a dose, do not take a double dose – this increases your risk of bleeding.
- Stroke prevention or blood clots: if the next dose is less than 6 hours away, skip the missed dose and carry on as normal. If there are more than six hours until the next dose, take the missed dose as soon as you remember. Do not take two doses at the same time.
- Knee or hip replacement: skip the missed dose and carry on as normal at the same time the next day. Do not take two doses at the same time.
- Extra care is needed when taking dabigatran because it can cause bleeding. Avoid new tattoos and piercings or having body massages while taking dabigatran; these things may cause bruising and bleeding.
- Do not store dabigatran in a pill box or medication reminder box. It must be kept tightly closed in the original package to protect it from moisture.
- It is important to let health professionals know that you are taking dabigatran, including your dentist, pharmacist, podiatrist and nurse. You may need to stop using this medicine for several days before having surgery, dental appointments or medical tests.
Precautions – before taking dabigatran
- Do you have problems with your kidneys or liver?
- Are you pregnant or breastfeeding?
- Have you ever had a stomach ulcer or bleeding in your brain?
If so, it’s important that you tell your doctor before you start taking dabigatran. Sometimes a medicine isn’t suitable for a person with certain conditions or taking other medicines, or it can only be used with extra care.
Possible side effects
Like all medicines, dabigatran can cause side effects, although not everyone gets them. Common side effects include nausea (feeling sick), indigestion, tummy cramps and headache. These may go away with time. Tell your doctor if troublesome.
Increased risk of bleeding
Dabigatran increases your risk of bleeding. You might bleed or bruise more easily while you are taking dabigatran.
Injuries or falls
Be careful when doing things that may cause bruising and bleeding, such as shaving, clipping your fingernails, brushing and flossing your teeth or playing sports. Avoid getting new tattoos and piercings. Minor bleeding should usually stop on its own. If you have a fall or hurt your head or body, get medical attention immediately, even if you feel okay.
Signs of severe bleeding
If you have any of the following signs of bleeding, contact your doctor immediately or ring Healthline for free 24 hour health advice on 0800 611 116:
- becoming pale, very weak and tired, or short of breath
- any bleeding from your gums, cuts or nosebleeds that won’t stop
- blood in the stools (poo) – black, tarry stools
- blood in the urine (wee) – pink, red or brown-coloured urine
- heavy periods (menstrual bleeding)
- coughing up blood or vomit that looks like coffee grounds.
Dabigatran should not be taken with some other medications and herbal supplements, so always check with your doctor or pharmacist before starting dabigatran or before starting any new medicines. Also check with a pharmacist before taking:
Taking these together with dabigatran may increase your risk of bleeding and should be avoided.
The following links have more information on dabigatran:
- The safe and effective use of dabigatran and warfarin in primary care BPAC, NZ, 2017
- An update on managing patients with atrial fibrillation BPAC, NZ, 2017
- Dabigatran etexilate New Zealand Formulary
How does this medication work? What will it do for me?
Dabigatran belongs to the family of medications called anticoagulants. Anticoagulants prevent harmful blood clots from forming in the blood vessels by reducing the ability of the blood to clot. Dabigatran is used to prevent blood clots for people who have had total hip replacement or knee replacement surgery.
Dabigatran is also used to treat blood clots for people who have had a deep vein thrombosis (DVT; a blood clot in the major arteries, particularly the leg), pulmonary embolism (blood clot in the lung), and to prevent these clots from happening again.
Dabigatran is also used to prevent stroke or blood clots in people with atrial fibrillation.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each light blue and cream-coloured capsule filled with yellowish pellets, imprinted with the Boehringer Ingelheim company symbol on one end and “R75” on the other end, contains 75 mg of dabigatran etexilate base. Nonmedicinal ingredients: tartaric acid, acacia, hypromellose, dimethicone, talc, and hydroxypropyl cellulose; capsule shell: carragenan, potassium chloride, titanium dioxide, Sunset Yellow (E 110), Indigo Carmin (132), hypromellose, purified water, shellac, iron oxide black, and propylene glycol.
Each light blue and cream-coloured capsule filled with yellowish pellets, imprinted with the Boehringer Ingelheim company symbol on one end and “R110” on the other end, contains 110 mg of dabigatran etexilate base. Nonmedicinal ingredients: tartaric acid, acacia, hypromellose, dimethicone, talc, and hydroxypropyl cellulose; capsule shell: carragenan, potassium chloride, titanium dioxide, Sunset Yellow (E 110), Indigo Carmin (132), hypromellose, purified water, shellac, iron oxide black, and propylene glycol.
Each light blue and cream-coloured capsule filled with yellowish pellets, imprinted with the Boehringer Ingelheim company symbol on one end and “R150” on the other end, contains 150 mg of dabigatran etexilate base. Nonmedicinal ingredients: tartaric acid, acacia, hypromellose, dimethicone 350, talc, and hydroxypropyl cellulose; capsule shell: carragenan, potassium chloride, titanium dioxide, Sunset Yellow (E 110), Indigo Carmin (132), hypromellose, purified water, shellac, iron oxide black, and propylene glycol.
How should I use this medication?
For knee replacement surgery, the usual dose of dabigatran is 110 mg (one capsule) taken by mouth between 1 and 4 hours after the surgery, followed by 220 mg (2 capsules) once daily for a total of 10 days. If treatment is not started on the day of surgery, then treatment should be started with a dose of 220 mg once daily. For people over the age of 75 years, the doctor may recommend a lower dose of 150 mg taken once daily.
For hip replacement surgery, the usual dose of dabigatran is 110 mg (one capsule) taken by mouth between 1 and 4 hours after the surgery, followed by 220 mg (2 capsules) once daily for a total of 28 to 35 days. If treatment is not started on the day of surgery, then treatment should be started with a dose of 220 mg once daily.
To treat or prevent blood clots in the lungs or veins of your legs the usual dose is 300 mg taken as one 150 mg capsule twice daily following 5-10 days of treatment with an injectable blood thinner. For people over the age of 80 years, or those with a high risk of bleeding, the doctor may recommend a lower dose of 220 mg taken as one 110 mg capsule twice daily.
For stroke and clot prevention in people with atrial fibrillation, the usual dose is 300 mg taken as one 150 mg capsule twice daily. For people over the age of 80 years, or those with a high risk of bleeding, the doctor may recommend a lower dose of 220 mg taken as one 110 mg capsule twice daily.
Dabigatran may be taken with food or on an empty stomach, with water. If you experience heartburn or upset stomach, take dabigatran with food. Swallow the capsules whole. Do not open, break, or chew the capsules.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important that this medication be taken exactly as prescribed by your doctor.
- For hip or knee replacement surgery: if you miss a dose, skip the missed dose and continue with your regular dosing schedule.
- For treatment or prevention of blood clots in the lungs or veins of your legs: if you miss a dose, and there are more than 6 hours before your next dose, take the missed dose and continue with your regular dosing schedule. If there are less than 6 hours before your next dose, skip the missed dose and continue with your regular dosing schedule.
- For treatment of atrial fibrillation: if you miss a dose, and there are more than 6 hours before your next dose, take the missed dose and continue with your regular dosing schedule. If there are less than 6 hours before your next dose, skip the missed dose and continue with your regular dosing schedule.
Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take dabigatran if you:
- are allergic to dabigatran or any ingredients of this medication
- are taking certain other medications such as ketoconazole that may increase the amount of this medication in the body
- are taking any other medications to reduce blood clotting (e.g., warfarin, heparin, enoxaparin)
- have any condition that is associated with an increased risk of bleeding (e.g., bleeding problems)
- have or have had a body lesion at risk of bleeding, such as a stroke within the past 6 months
- have severely reduced kidney function
- have a prosthetic heart valve and require other medication to reduce blood clotting
- are breast feeding
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- bruising (mild)
- difficulty swallowing
- stomach pain
- upset stomach
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- bleeding or oozing from the surgical wound
- joint pain or swelling
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, cuts that don’t stop bleeding, bleeding in the rectum or from hemorrhoids, bleeding from where a catheter enters a vein)
- skin rash
- symptoms of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools, itching)
symptoms of unidentified bleeding (e.g., weakness, paleness, dizziness, headache, unexplained swelling)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of a serious allergic reaction (i.e., hives, difficulty breathing, or swelling of the face and throat)
- signs of bleeding in the stomach or digestive system (e.g., bloody, black, or tarry stools; spitting up of blood, vomiting blood or material that looks like coffee grounds)
- signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Heart valves: Bleeding events, such as strokes, have been reported to occur when dabigatran is used by someone who has a replacement heart valve. If you have had surgery to replace or repair a heart valve, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Increased bleeding risk: If you have an increased risk of bleeding (e.g., recent biopsy; major trauma; brain, spinal, or eye surgery; taking medications that increase the risk of bleeding; bleeding disorders; stomach or intestinal ulcers; stroke; inflammation of certain parts of the heart), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication is not recommended for people who are at a high risk of bleeding.
Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication is not recommended for people with severely decreased kidney function.
Liver function: If you have liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Spinal or epidural catheters: This medication should not be taken by people who have spinal or epidural catheters in place (or for 2 hours after their removal) or by people receiving pain medications through an epidural catheter.
Surgery: Your doctor may want to stop dabigatran for a few days prior to any planned surgery to prevent any unnecessary bleeding, so it is important to tell all of your doctors that you are taking dabigatran.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if dabigatran passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children less than 18 years of age.
Seniors: Seniors are more likely to have age-related reductions in kidney function. Your doctor may adjust your dose based on your kidney function.
What other drugs could interact with this medication?
There may be an interaction between dabigatran and any of the following:
- acetylsalicylic acid (ASA)
- antacids (e.g., aluminum hydroxide, sodium bicarbonate, calcium or magnesium compounds)
- “azole” antifungals (e.g., fluconazole, itraconazole, ketoconazole)
- estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
- ginkgo biloba
- grapefruit juice
- HIV protease inhibitors (e.g., nelfinavir, ritonavir, saquinavir)
- low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
- macrolide antibiotics (e.g., clarithromycin, erthyromycin)
- nonsteroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
- omega-3 fatty acids
- progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
- protein kinase inhibitors (e.g., dasatinib, crizotinib, lapatinib, nilotinib)
- proton pump inhibitors (e.g., lansoprazole, omeprazole)
- St. John’s wort
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
- serotonin-norepinephrine reuptake inhibitors (SNRIs; desvenlafaxine, duloxetine, venlafaxine)
- vitamin E
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Pradaxa
The FDA’s approval in 2010 of the blood-thinner dabigatran (Pradaxa) got many doctors excited. This drug got the green light after a head-to-head trial with warfarin (generic, Coumadin) in people with an irregular heart beat from atrial fibrillation.
Pradaxa was at least as effective as warfarin for preventing stroke-causing blood clots, and possibly caused fewer bleeding side effects. In addition, it is easier to use. Pradaxa doesn’t require frequent blood tests, and isn’t affected by food, like warfarin is.
“Clinicians in the United States are excited to have the first new oral anticoagulant in over half a century,” said Dr. Richard Becker, Director of the Cardiovascular Thrombosis Center at Duke School of Medicine in North Carolina, in an interview with the medical journal Nature Reviews Drug Discovery. “This approval gives clinicians an opportunity to select therapies based on patient need.”
Since then, studies of Pradaxa have slightly dampened the enthusiasm for the new drug. Take, for example, the results of a University of Pittsburgh survey of 9,400 men and women covered by Medicare. All had atrial fibrillation, an irregular heart rhythm that lets blood clots form in the heart. None had damaged heart valves. When these clots get into the bloodstream, they can cause strokes. In this group, 1,300 had been prescribed Pradaxa and 8,100 took warfarin. The researchers followed these men and women until they either stopped using the drug, switched to a different blood thinner, died, or until December 2011.
Among those taking Pradaxa, 9% experienced a major bleed, compared with 6% among those taking warfarin. The bleeding sites tended to differ. Bleeding in the stomach and intestines was slightly higher among Pradaxa users. Bleeding in the head was slightly higher among warfarin users. Black patients and those with chronic kidney disease were more likely to bleed from Pradaxa. The results were reported online in the journal JAMA Internal Medicine.
Reducing stroke risk from atrial fibrillation
For decades, the best way to prevent stroke from atrial fibrillation was by taking warfarin (Coumadin). But warfarin is a kind of “Goldilocks” drugs. You need regular blood tests to make sure the amount in your blood isn’t too high (which puts you at risk of bleeding) or too low (which puts you at risk of having a stroke). You also need to pay attention to what you eat, because a sudden meal with a lot of vitamin K can counteract warfarin.
Then came Pradaxa. After doctors had been prescribing it for a while, they noticed that it was causing more episodes of major bleeding than had been expected. The FDA ordered that additional studies be performed on the safety of Pradaxa in the real world.
Some studies, like the one from, the University of Pittsburgh, showed a higher bleeding risk with Pradaxa than with warfarin. Other studies show the opposite.
FDA approves other blood thinners
Since 2010, two other blood thinners have been approved to prevent strokes in people with atrial fibrillation and no heart valve problems: apixaban (Eliquis) and rivaroxaban (Xarelto). Post-approval studies on the safety of these drugs are still ongoing.
One downside of the three new drugs: they are much more expensive than warfarin. One upside: none require regular blood tests to adjust the dose. One big unknown: the long-term side effects.
Choosing the right blood thinner
How do you and your doctor decide which drug is right for you if you have atrial fibrillation? There is no right answer. Here are the questions I ask my patients:
- Is cost an issue? If yes, warfarin will be the likely choice.
- Are you sure you will take the medicine as prescribed? This is important for all drugs. But warfarin stays in the body longer, so you have a longer protection time if you miss a dose. That isn’t the case with the other three.
- Is it relatively easy for you to get a blood test? If the answer is no, then one of the newer drugs might be better.
I usually start my patients with atrial fibrillation on warfarin. I do this mainly because I take a conservative approach to new drugs. Also I have many years of experience with warfarin. If the patient has trouble keeping his or her warfarin levels in the proper range, I then consider switching to one of the newer drugs.
I might start with a newer blood thinner in a person a higher-than-average risk of bleeding into or around the brain. Examples include a person with:
- uncontrolled high blood pressure
- previous bleeding inside the head
- a family member who has had episodes of bleeding inside the head
- excessive alcohol use.
Patient Education Blog
Stephan Moll, MD, writes…
Does drinking alcohol change the INR in a patient on warfarin?
Surprisingly little published data exist on the interaction of alcohol and warfarin. The interaction seems to be complex.
- A review article concluded:
- Intermediate use (2-3 drinks per day) probably does not alter the INR at all.
- Intermittent large amount of alcohol drinking leads to an increase in INR, because the alcohol interferes with warfarin metabolism, i.e. warfarin is metabolized less rapidly. However, this effect may be minimal .
- Chronic heavy alcohol intake results in a decreased INR, because the alcohol actually increases the metabolism of warfarin. That means, patients will need more warfarin.
- Individuals who are on warfarin and drink alcohol, even those who drink moderately or heavily, are not more likely going to be over-anticoagulated, i.e. have INRs above 6.0, than individuals who do not drink .
Does drinking alcohol increase the risk for bleeding on warfarin?
- The National Institute of Alcohol Abuse and Alcoholism in its “warfarin and alcohol interactions” section makes the sweeping statement that “occasional drinking may lead to internal bleedin; heavier drinking also may cause bleeding or may have the opposite effect, resulting in possible blood clots” .
- A 2011 study showed that patients who drank alcohol (> 20 U of alcohol per week; that equals about 1 ½ liters of wine per week, or 10 pints of beer) and were on warfarin did not have more bleeding .
I typically tell patients on warfarin (Coumadin®, Jantoven®) that drinking mild to moderate amounts of alcohol (up to 1-2 glasses of wine or 1-2 beers per day) is probably safe from a clotting and bleeding point of view and that there is no reason to abstain completely from alcohol while on warfarin.
Pradaxa and Alcohol
To my knowledge, there is nothing indicating an interaction between alcohol and Pradaxa (dabigatran). The specific resources:
- Pradaxa prescribing information: There is no mention in the FDA-approved summary prescription handout; nothing in the full prescribing information.
- Official Pradaxa website: “No known dietary restrictions” European Medicine Agency prescribing information: Nothing mentioned about alcohol.
- British National Health Service: “There are no known interactions between alcohol and Pradaxa”.
Xarelto and Alcohol
To my knowledge, there is nothing indicating an interaction between alcohol and Xarelto (rivaroxaban). The specific resources:
- There is no mention of alcohol in the prescribing information.
- There is a wide range of advice from individual physicians on the internet….from avoidance of alcohol to limiting alcohol intake…yet no data basis for these recommendation.
- This leaves me with a common sense conclusion: mild to moderate alcohol intake is likely fine. Heavy alcohol intake should be avoided.
- Buckley NA et al: “Drug interactions with warfarin”. Med J Aust 1992;157:479-483.
- Mukamal KJ et al. Moderate alcohol consumption and safety of lovastatin and warfarin among men: the post-coronary artery bypass graft trial. Am J Med. 2006;May;119(5):434-440.
- Hylek EM, Heiman H, Skates SJ, Sheehan MA, Singer DE. Acetaminophen and other risk factors for excessive warfarin anticoagulation. JAMA. 1998;279:657-662.
- Lip GY et al. Comparative validation of a novel risk score for predicting bleeding risk in anticoagulated patients with atrial fibrillation: the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) score. J Am Coll Cardiol. 2011 Jan 11;57(2):173-180.
- Penning-van Beest FJA et al: “Lifestyle and diet as risk factors for overanticoagulation”. J Clin Epidemiol 2002;55:411-417.
- Weathermon R, Crabb DW. Alcohol and medication interactions.Alcohol Res Health. 1999;23:40-54.
Last updated: June 25th, 2013