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Pradaxa Side Effects

Common Pradaxa Side Effects

The most commonly reported Pradaxa side effects (click to view or check a box to report):

Gastrointestinal Haemorrhage (2001)
Anaemia (738)
Cerebrovascular Accident (730)
Haemorrhage (675)
Fall (571)
Rectal Haemorrhage (533)
Dizziness (423)
Renal Failure Acute (423)
Dyspepsia (391)
Coagulopathy (386)
Haemorrhagic Anaemia (381)
Dyspnoea (367)
Ischaemic Stroke (358)
Contusion (349)
Epistaxis (334)
Nausea (330)
Asthenia (325)
Melaena (319)
Haemoglobin Decreased (316)
Death (303)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Pradaxa Side Effects Reported to FDA

The following Pradaxa reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Pradaxa on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Tooth Abscess, Dental Caries, Off Label Use
on Mar 12, 2014 Female from CA , weighting 264.6 lb, was diagnosed with and was treated with Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: tooth abscess, dental caries, off label use. Pradaxa dosage: 300 Mg.

Pulmonary Embolism
Patient was taking Pradaxa. Patient felt the following Pradaxa side effects: pulmonary embolism on Mar 20, 2014 from FR Additional patient health information: Female , weighting 99.21 lb, . Pradaxa dosage: 75 Mg. Patient was hospitalized.

Asthenia, Haematemesis, Rectal Haemorrhage, Malaise, Hypophagia, Haemoglobin Decreased, Prothrombin Time Prolonged, Blood Urea Increased, Blood Creatinine Increased
Adverse event was reported on Mar 11, 2014 by a Female taking Pradaxa (Dosage: N/A) was diagnosed with and. Location: US , 82 years of age, weighting 207.2 lb, After Pradaxa was administered, patient encountered several Pradaxa side effects: asthenia, haematemesis, rectal haemorrhage, malaise, hypophagia, haemoglobin decreased, prothrombin time prolonged, blood urea increased, blood creatinine increased.
Multiple concurrent drugs taken:
  • Sotalol
  • Meclizine
  • Colchicine
  • Glimeperide
  • Loperamide
  • Rosuvastatin
  • Ezitimibe
  • Amlodipine
Patient was hospitalized.

Anorgasmia, Loss Of Libido
on Mar 11, 2014 Female from US , 85 years of age, was diagnosed with and was treated with Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: anorgasmia, loss of libido. Pradaxa dosage: 300 Mg.
Associated medications used:
  • Crestor
  • Nexium



Hypoaesthesia
on Mar 11, 2014 Male from US , 62 years of age, was diagnosed with and was treated with Pradaxa. Patient felt the following Pradaxa side effects: hypoaesthesia. Pradaxa dosage: 300 Mg.

Dizziness, Cellulitis, Dyspnoea Exertional, Faeces Discoloured, Haemoptysis
Patient was taking Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: dizziness, cellulitis, dyspnoea exertional, faeces discoloured, haemoptysis on Mar 11, 2014 from US Additional patient health information: Male , 79 years of age, weighting 149.9 lb, was diagnosed with and. Pradaxa dosage: 300 Mg.

Gastrointestinal Haemorrhage, Haemorrhagic Anaemia
Adverse event was reported on Mar 11, 2014 by a Male taking Pradaxa (Dosage: 300 Mg) was diagnosed with and. Location: US , weighting 170.0 lb, Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: gastrointestinal haemorrhage, haemorrhagic anaemia.
Associated medications used:
  • Atenolol
Patient was hospitalized.

Hypertensive Crisis, Confusional State
on Mar 11, 2014 Female from DE , 75 years of age, was diagnosed with and was treated with Pradaxa. Patient felt the following Pradaxa side effects: hypertensive crisis, confusional state. Pradaxa dosage: 300 Mg.
Multiple prescriptions taken:
  • Metoprolol


Arthritis
on Mar 11, 2014 Female from US , weighting 134.5 lb, was diagnosed with and was treated with Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: arthritis. Pradaxa dosage: 150 Mg.
Multiple concurrent drugs taken:
  • Imdur (300 Mg)
  • Lopressor (12.5 Mg)
  • Digoxin (0.125 Mg)
  • Prilosec (40 Mg)
  • Lasix (80 Mg)
  • K-dur Er (40 Meq)
  • Paxil (12.5 Mg)
  • Gabapentin (1200 Mg)


Gastrointestinal Haemorrhage, Haemoglobin Decreased
Patient was taking Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: gastrointestinal haemorrhage, haemoglobin decreased on Mar 10, 2014 from US Additional patient health information: Male , 67 years of age, weighting 281.0 lb, was diagnosed with and. Pradaxa dosage: N/A.
Associated medications used:
  • Spironolactone
  • Zosyn
  • Zyvox
  • Atorvastatin
  • Clonidine
  • Imdur
  • Diltiazem
  • Pentasa Cr
Patient was hospitalized.

Cerebrovascular Accident
Adverse event was reported on Mar 11, 2014 by a Female taking Pradaxa (Dosage: N/A) was diagnosed with and. Location: SE , 79 years of age, Patient felt the following Pradaxa side effects: cerebrovascular accident. Patient was hospitalized.

Paraesthesia
on Mar 11, 2014 Female from SE , 71 years of age, was treated with Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: paraesthesia. Pradaxa dosage: N/A.

Pneumonia
on Mar 11, 2014 Male from US , 78 years of age, weighting 178.6 lb, was diagnosed with and was treated with Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: pneumonia. Pradaxa dosage: 300 Mg.
Associated medications used:
  • Advair (Formulation: Inhaler)
  • Amlodipine (5 Mg)
  • Lovestatin (40 Mg)
  • Finasteride (5 Mg)
  • Inhaler
Patient was hospitalized.

Arthritis, Alopecia
Patient was taking Pradaxa. Patient felt the following Pradaxa side effects: arthritis, alopecia on Mar 11, 2014 from US Additional patient health information: Female , weighting 154.3 lb, was diagnosed with and. Pradaxa dosage: 300 Mg.
Multiple prescriptions taken:
  • Atenolol (25 Mg)
  • Lisniopril (5 Mg)


Tooth Abscess, Tooth Fracture, Dyspepsia
Adverse event was reported on Mar 11, 2014 by a Female taking Pradaxa (Dosage: 300 Mg) was diagnosed with and. Location: US , 80 years of age, weighting 125.7 lb, After Pradaxa was administered, patient encountered several Pradaxa side effects: tooth abscess, tooth fracture, dyspepsia.
Multiple concurrent drugs taken:
  • Cozaar


Haemothorax
on Mar 10, 2014 Male from FR , 75 years of age, was diagnosed with and was treated with Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: haemothorax. Pradaxa dosage: 300 Mg. Patient was hospitalized.

Chest Pain
on Mar 10, 2014 Male from US , 64 years of age, was diagnosed with and was treated with Pradaxa. Patient felt the following Pradaxa side effects: chest pain. Pradaxa dosage: 300 Mg. Patient was hospitalized.

Atrial Fibrillation
Patient was taking Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: atrial fibrillation on Mar 10, 2014 from US Additional patient health information: Male , 80 years of age, was diagnosed with and. Pradaxa dosage: 150 Mg.

Shock Haemorrhagic
Adverse event was reported on Mar 10, 2014 by a Female taking Pradaxa (Dosage: N/A) was diagnosed with and. Location: FR , 89 years of age, Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: shock haemorrhagic.
Associated medications used:
  • Cordarone
  • Atenol
  • Cortancyl
  • Lexomil 12mg (6 Mg)
  • Stilnox 10mg
  • Coolmetec
  • Xatral
  • Exelon


Myocardial Infarction, Chest Discomfort, Dyspnoea, Acute Myocardial Infarction
on Mar 10, 2014 Male from GB , 78 years of age, weighting 165.3 lb, was diagnosed with and was treated with Pradaxa. Patient felt the following Pradaxa side effects: myocardial infarction, chest discomfort, dyspnoea, acute myocardial infarction. Pradaxa dosage: 150 Mg.
Multiple prescriptions taken:
  • Allopurinol
  • Pravastatin
  • Pregabalin
  • Quinine Sulphate
  • Salbutamol
Patient was hospitalized.

Cerebrovascular Accident, Atrial Fibrillation
on Mar 10, 2014 Male from US , 44 years of age, weighting 295.4 lb, was diagnosed with and was treated with Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: cerebrovascular accident, atrial fibrillation. Pradaxa dosage: 300 Mg.
Multiple concurrent drugs taken:
  • Toprol Xl (300 Mg)
  • Spironolactone (50 Mg)
  • Furosemide (80 Mg)
  • Parvastitin (40 Mg)
  • Digoxin
  • Carvedilol (50 Mg)
  • Paxil (20 Mg)
Patient was hospitalized.

Dyspepsia, Limb Injury, Haemorrhage, Eructation
Patient was taking Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: dyspepsia, limb injury, haemorrhage, eructation on Mar 10, 2014 from US Additional patient health information: Female , 79 years of age, weighting 160.9 lb, was diagnosed with and. Pradaxa dosage: 300 Mg.
Associated medications used:
  • Simvastatin (10 Mg)
  • Sotalol (120 Mg)
  • Sotalol
  • Losartan (100 Mg)
  • Losartan
  • Vitamins


Peripheral Coldness, Pain In Extremity
Adverse event was reported on Mar 10, 2014 by a Female taking Pradaxa (Dosage: 150 Mg) was diagnosed with and. Location: US , weighting 229.3 lb, Patient felt the following Pradaxa side effects: peripheral coldness, pain in extremity.
Multiple prescriptions taken:
  • Amiodarone


Cerebrovascular Accident
on Mar 10, 2014 Male from PH , 75 years of age, was diagnosed with and was treated with Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: cerebrovascular accident. Pradaxa dosage: 15.7143 Mg. Patient was hospitalized.

Lung Neoplasm Malignant, Dyspnoea, Blister
on Mar 10, 2014 Female from US , 79 years of age, weighting 185.2 lb, was diagnosed with and was treated with Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: lung neoplasm malignant, dyspnoea, blister. Pradaxa dosage: 300 Mg.
Associated medications used:
  • Cardiazem Xr (240 Mg)
  • Digoxin (0.125 Mg)
  • Vitamin D (20000 U)
  • Advair (Formulation: Inhalation Aerosol; Strength: 1 Inhalation; Daily Dose: 2 Inhalation)
  • Morphine (5 Mg)
  • Omeprazole (20 Mg)
  • Levothyroxine (0.137 Mg)
Patient was hospitalized.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Discuss Pradaxa Side Effects

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    How Effective is Pradaxa for You?

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    Safety Alerts, Active Ingredients, Usage Information

    Alternative PRADAXA Names:DABIGATRA

    Active Ingredient: DABIGATRA

    More About Pradaxa

    Side Effects reported to FDA: 13372

    Pradaxa safety alerts: 2013 2012 2011

    Reported deaths: 2542

    Reported hospitalizations: 7883

    Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events

     

    UPDATED 11/02/2012. The FDA evaluated new information about the risk of serious bleeding associated with use of the anticoagulants (blood thinners) dabigatran (Pradaxa) and warfarin (Coumadin, Jantoven, and generics). This assessment was done using insurance claims and administrative data from FDA’s Mini-Sentinel pilot of the Sentinel Initiative. The results of this assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial). FDA is continuing to evaluate multiple sources of data in the ongoing safety review of this issue. See the Data Summary in the 11/02/2012 Drug Safety Communication below for additional information.
     
    FDA has not changed its recommendations regarding Pradaxa. Pradaxa provides an important health benefit when used as directed. Healthcare professionals who prescribe Pradaxa should carefully follow the dosing recommendations in the drug label, especially for patients with renal impairment (when kidneys don’t function normally) to reduce the risk of bleeding. Patients with atrial fibrillation should not stop taking Pradaxa without first talking to their healthcare professional. Stopping use of anticoagulant medications such as Pradaxa can increase the risk of stroke. Strokes can lead to permanent disability and death.

     

    Posted 12/07/2011

    AUDIENCE: Cardiology, Pharmacy, Hematology

    ISSUE: (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a large clinical trial (18,000 patients) comparing Pradaxa and warfarin, major bleeding events occurred at similar rates with the two drugs.

    FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa.

    BACKGROUND: Pradaxa is a blood thinning (anticoagulant) medication used to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AF), the most common type of heart rhythm abnormality.

    RECOMMENDATION: At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.

    Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke. Strokes can lead to permanent disability and death.

    FDA will communicate any new information on the risk of bleeding and Pradaxa when it becomes available.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [11/02/2012 - Drug Safety Communication - FDA]
    [12/07/2011 - Drug Safety Communication - FDA]

    Latest Pradaxa clinical trials