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Pradaxa Side Effects

Report Pradaxa Side Effects

If you experienced any harmful or unwanted effects of Pradaxa, please share your experience. This could help to raise awareness about Pradaxa side effects, identify uknown risks and inform health professionals and patients taking Pradaxa.

Examples: headache, dizziness


The most commonly reported Pradaxa side effects are:
Fatigue (424 reports)
Gas (346 reports)
Gastrointestinal Issues (222 reports)
Extreme Fatigue (175 reports)
Tiredness (150 reports)
Swelling Legs (143 reports)
Gastrointestinal Issues And Extreme Fatigue (78 reports)
Shortness Of Breath (62 reports)
Pain (52 reports)

If you have experienced a side effect listed above, you can check a box to report it.


To view a complete list of submitted side effects, please follow the link Pradaxa side effects . You can also compare Pradaxa side effects or view FDA reports.

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).
The 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 identified a causal relationship between the drug and the listed risk.

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Transient Ischaemic Attack
on Mar 10, 2014 Male from COUNTRY NOT SPECIFIED , 52 years of age, was diagnosed with and was treated with Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: transient ischaemic attack. Pradaxa dosage: 300 Mg.

Transient Ischaemic Attack
Patient was taking Pradaxa. Patient felt the following Pradaxa side effects: transient ischaemic attack on Mar 10, 2014 from CA Additional patient health information: Female , 74 years of age, . Pradaxa dosage: 220 Mg.
Multiple prescriptions taken:

Cerebral Haemorrhage
Adverse event was reported on Mar 13, 2014 by a Female taking Pradaxa (Dosage: 300 Mg) was diagnosed with and. Location: US , 83 years of age, After Pradaxa was administered, patient encountered several Pradaxa side effects: cerebral haemorrhage. Patient was hospitalized.

Cerebral Haematoma, Anaemia, Tonsillar Haemorrhage
on Mar 10, 2014 Female from FR , 82 years of age, was treated with Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: cerebral haematoma, anaemia, tonsillar haemorrhage. Pradaxa dosage: 300 Mg.


Cerebral Haemorrhage
on Mar 10, 2014 Female from CA , 83 years of age, was diagnosed with and was treated with Pradaxa. Patient felt the following Pradaxa side effects: cerebral haemorrhage. Pradaxa dosage: 300 Mg.

Gastrointestinal Haemorrhage, Intestinal Perforation
Patient was taking Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: gastrointestinal haemorrhage, intestinal perforation on Mar 10, 2014 from CA Additional patient health information: Female , 78 years of age, was diagnosed with and. Pradaxa dosage: 300 Mg.

Rectal Haemorrhage, Abdominal Pain, Gastric Ulcer
Adverse event was reported on Mar 07, 2014 by a Female taking Pradaxa (Dosage: 150 Mg) was diagnosed with and. Location: US , 72 years of age, Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: rectal haemorrhage, abdominal pain, gastric ulcer.
Associated medications used:
  • Ramipril (2.5 Mg)
  • Carvedilol (6.25 Mg)
  • Escitalopram (20 Mg)
  • Potassium (20 Meq)
  • Amiodarone (100 Mg)
  • Furosemide (40 Mg)
  • Levothyroxine (75 Mcg)
  • Simvastatin (20 Mg)
Patient was hospitalized.

Upper Gastrointestinal Haemorrhage, Lower Gastrointestinal Haemorrhage, Cardiac Failure
on Mar 17, 2014 Patient from JP , 80 years of age, was diagnosed with and was treated with Pradaxa. Patient felt the following Pradaxa side effects: upper gastrointestinal haemorrhage, lower gastrointestinal haemorrhage, cardiac failure. Pradaxa dosage: 220 Mg. Patient was hospitalized.

Incontinence, Decreased Appetite, Weight Decreased
on Mar 07, 2014 Female from US , 83 years of age, weighting 160.9 lb, was diagnosed with and was treated with Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: incontinence, decreased appetite, weight decreased. Pradaxa dosage: 300 Mg.
Multiple concurrent drugs taken:

Acute Myocardial Infarction, Cardiac Failure, Pulmonary Oedema, Haematuria, Haemoglobin Decreased
Patient was taking Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: acute myocardial infarction, cardiac failure, pulmonary oedema, haematuria, haemoglobin decreased on Mar 07, 2014 from IL Additional patient health information: Female , 77 years of age, was diagnosed with and. Pradaxa dosage: 300 Mg.
Associated medications used: Patient was hospitalized.

Volvulus
Adverse event was reported on Mar 28, 2014 by a Male taking Pradaxa (Dosage: 300 Mg) was diagnosed with and. Location: US , 83 years of age, weighting 205.0 lb, Patient felt the following Pradaxa side effects: volvulus. Patient was hospitalized.

Acute Coronary Syndrome, Haemorrhage
on Mar 07, 2014 Male from FR , 90 years of age, was diagnosed with and was treated with Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: acute coronary syndrome, haemorrhage. Pradaxa dosage: 220 Mg.
Multiple concurrent drugs taken:
  • Cetirizine (10 Mg)
  • Oxynorm 5 Mg (15 Mg)
  • Oxycontin Er 5 Mg (30 Mg)
  • Transipeg
  • Mecir Er (0.4 Mg)
  • Atarax
  • Spririva
  • Seretide
Patient was hospitalized.

Fall, Rib Fracture
on Mar 07, 2014 Female from US , 96 years of age, weighting 108.0 lb, was diagnosed with and was treated with Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: fall, rib fracture. Pradaxa dosage: 150 Mg. Patient was hospitalized.

Ischaemic Stroke
Patient was taking Pradaxa. Patient felt the following Pradaxa side effects: ischaemic stroke on Mar 07, 2014 from BG Additional patient health information: Female , 87 years of age, was diagnosed with and. Pradaxa dosage: 150 Mg.
Multiple prescriptions taken: Patient was hospitalized.

Local Swelling, Dyspnoea, Gait Disturbance
Adverse event was reported on Mar 07, 2014 by a Female taking Pradaxa (Dosage: 300 Mg) was diagnosed with and. Location: US , 77 years of age, weighting 143.3 lb, After Pradaxa was administered, patient encountered several Pradaxa side effects: local swelling, dyspnoea, gait disturbance.
Multiple concurrent drugs taken:

Mental Status Changes
on Mar 07, 2014 Female from KR , 76 years of age, was diagnosed with and was treated with Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: mental status changes. Pradaxa dosage: 220 Mg.
Associated medications used:
  • Kanarb Tab / Fimasartan 120mg (120 Mg)
  • Aspirin Protect / Aspirin 100mg (100 Mg)
  • Platless Tab / Clopidogrel 75mg (75 Mg)
  • Mosarone Tab / Mosapride 5mg (10 Mg)
  • Stillen Tab / Artemisia Asiatica 95% Ethanol Ext. (120 Mg)
Patient was hospitalized.

Heart Rate Decreased
on Mar 06, 2014 Female from US , 76 years of age, was diagnosed with and was treated with Pradaxa. Patient felt the following Pradaxa side effects: heart rate decreased. Pradaxa dosage: 300 Mg.
Multiple prescriptions taken:
  • Sotalol
  • Premarin
  • Digoxin
  • Synthroid
  • Prednisone


Haematuria, Renal Impairment
Patient was taking Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: haematuria, renal impairment on Mar 06, 2014 from COUNTRY NOT SPECIFIED Additional patient health information: Male , 89 years of age, weighting 216.1 lb, was diagnosed with and. Pradaxa dosage: 220 Mg. Patient was hospitalized.

Visual Acuity Reduced, Retinal Vascular Thrombosis
Adverse event was reported on Mar 06, 2014 by a Female taking Pradaxa (Dosage: 300 Mg) was diagnosed with and. Location: COUNTRY NOT SPECIFIED , 68 years of age, Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: visual acuity reduced, retinal vascular thrombosis.
Associated medications used:

Gastrointestinal Haemorrhage, Renal Impairment
on Mar 06, 2014 Male from COUNTRY NOT SPECIFIED , 67 years of age, weighting 185.2 lb, was diagnosed with and was treated with Pradaxa. Patient felt the following Pradaxa side effects: gastrointestinal haemorrhage, renal impairment. Pradaxa dosage: 220 Mg. Patient was hospitalized.

Deep Vein Thrombosis
on Mar 06, 2014 Female from FR , 78 years of age, was treated with Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: deep vein thrombosis. Pradaxa dosage: 220 Mg.
Multiple concurrent drugs taken:

Pulmonary Embolism
Patient was taking Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: pulmonary embolism on Mar 06, 2014 from FR Additional patient health information: Male , 83 years of age, . Pradaxa dosage: 150 Mg.
Associated medications used: Patient was hospitalized.

Gastrointestinal Haemorrhage, Renal Impairment
Adverse event was reported on Mar 06, 2014 by a Female taking Pradaxa (Dosage: 220 Mg) was diagnosed with and. Location: COUNTRY NOT SPECIFIED , 87 years of age, weighting 176.4 lb, Patient felt the following Pradaxa side effects: gastrointestinal haemorrhage, renal impairment. Patient was hospitalized.

Basal Ganglia Haemorrhage, Thalamus Haemorrhage, Brain Midline Shift, Cerebral Haematoma
on Mar 06, 2014 Male from COUNTRY NOT SPECIFIED , 85 years of age, weighting 165.3 lb, was diagnosed with and was treated with Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: basal ganglia haemorrhage, thalamus haemorrhage, brain midline shift, cerebral haematoma. Pradaxa dosage: 300 Mg.
Multiple concurrent drugs taken:
  • Atorvastatin (10 Mg)
  • Losartan-hydrochlorothiazide (50-12.5mg Daily)
  • Omeprazole (20 Mg)
Patient was hospitalized.

Nasopharyngitis
on Mar 05, 2014 Female from US , 71 years of age, weighting 200.6 lb, was diagnosed with and was treated with Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: nasopharyngitis. Pradaxa dosage: 300 Mg.
Associated medications used:

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Record and Track Your Side Effects

It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

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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