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 Pradaxa (Dabigatran-etexilate). If you are concerned about side effects, discuss the risks and benefits of Pradaxa (Dabigatran-etexilate) with your doctor.

The following side effects have been reported by at least 1% of people taking Pradaxa (Dabigatran-etexilate). 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)
• Diarrhea
• difficulty swallowing
• hair loss
• heartburn/reflux
• nausea
• stomach pain
• upset stomach
• vomiting

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:

• 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)
• signs of infection (e.g., Fever, chills, cough, difficulty breathing, unusual fatigue)
• 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:

• bleeding (severe) from a surgical wound
• 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 Pradaxa (Dabigatran-etexilate).

75 mg
Each white opaque 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, hypromellose, potassium chloride, purified water, and titanium dioxide; printing ink: iron oxide black, potassium hydroxide, propylene glycol, and shellac.

110 mg
Each light blue opaque 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, hypromellose, Indigo Carmin (132), potassium chloride, titanium dioxide, and purified water; printing ink: iron oxide black, potassium hydroxide, propylene glycol, and shellac.

150 mg
Each light blue and white opaque 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, hypromellose, Indigo Carmin (132), potassium chloride, titanium dioxide, and purified water; printing ink: iron oxide black, potassium hydroxide, propylene glycol, and shellac.

Do not take dabigatran if you:

• are allergic to dabigatran or any ingredients of Pradaxa (Dabigatran-etexilate)
• are taking certain other medications such as ketoconazole or glecaprevir-pibrentasvir that may increase the amount of Pradaxa (Dabigatran-etexilate) in the body
• are taking any other medications to reduce blood clotting (e.g., Warfarin, Heparin, Enoxaparin)
• have active bleeding
• 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

There may be an interaction between dabigatran and any of the following:

• acetylsalicylic acid (Asa)
• alteplase
• Amiodarone
• antacids (e.g., aluminum hydroxide, sodium bicarbonate, calcium or magnesium compounds)
• Apalutamide
• Apixaban
• argatroban
• "azole" antifungals (e.g., fluconazole, itraconazole, ketoconazole)
• Carbamazepine
• Carvedilol
• Clopidogrel
• Cobicistat
• Cyclosporine
• Deferasirox
• Dipyridamole
• Dronedarone
• Edoxaban
• Eliglustat
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Flibanserin
• garlic
• ginger
• ginkgo biloba
• ginseng
• heparin
• Hepatitis C antivirals (e.g., daclatasvir, glecaprevir and pibrentasvir, ledipasvir, velpatasvir)
• HIV protease inhibitors (e.g., nelfinavir, ritonavir, saquinavir)
• Ivacaftor
• low molecular weight heparins (e.g., Dalteparin, enoxaparin, Tinzaparin)
• lumacaftor and ivacaftor
• macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
• mifepristone
• nonsteroidal anti-inflammatory medications (NSAIDs; e.g., Diclofenac, Ibuprofen, Naproxen)
• Obinutuzumab
• omega-3 fatty acids
• Phenobarbital
• Phenytoin
• Prasugrel
• primidone
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• protein kinase inhibitors (e.g., Dasatinib, Crizotinib, Lapatinib, Nilotinib)
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• quinidine
• quinine
• rifampin
• Rivaroxaban
• St. John's wort
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin-norepinephrine reuptake inhibitors (SNRIs; Desvenlafaxine, Duloxetine, Venlafaxine)
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• Tacrolimus
• Ticagrelor
• Ticlopidine
• Verapamil
• vitamin E
• vorapaxar
• warfarin

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 Pradaxa (Dabigatran-etexilate). 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.

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 Pradaxa (Dabigatran-etexilate).

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 Pradaxa (Dabigatran-etexilate) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pradaxa (Dabigatran-etexilate), 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; or inflammation of certain parts of the heart), discuss with your doctor how Pradaxa (Dabigatran-etexilate) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pradaxa (Dabigatran-etexilate), and whether any special monitoring is needed. Pradaxa (Dabigatran-etexilate) is not recommended for people who are at a high risk of bleeding.

Kidney function: Kidney Disease or reduced kidney function may cause Pradaxa (Dabigatran-etexilate) to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Pradaxa (Dabigatran-etexilate) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pradaxa (Dabigatran-etexilate), and whether any special monitoring is needed. Pradaxa (Dabigatran-etexilate) is not recommended for people with severely decreased kidney function.

Liver function: Dabigatran may cause liver problems. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately. If you have liver disease, discuss with your doctor how Pradaxa (Dabigatran-etexilate) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Pradaxa (Dabigatran-etexilate), and whether any special monitoring is needed.

Spinal or epidural catheters: Pradaxa (Dabigatran-etexilate) 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: Pradaxa (Dabigatran-etexilate) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Pradaxa (Dabigatran-etexilate), 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 Pradaxa (Dabigatran-etexilate), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Pradaxa (Dabigatran-etexilate) 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.