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Pradaxa Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 6005 

Upper Gastrointestinal Haemorrhage (8476520-X)
on Jun 21, 2012 Female from UNITED STATES , 95 years of age, was diagnosed with
  • cerebrovascular accident prophylaxis
and was treated with Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: upper gastrointestinal haemorrhage. Pradaxa dosage: 300 Mg. Patient was hospitalized.

Alanine Aminotransferase Increased, Blood Pressure Decreased, Malaise, Aspartate Aminotransferase Increased, Vomiting (8476515-6)
Patient was taking Pradaxa. Patient felt the following Pradaxa side effects: alanine aminotransferase increased, blood pressure decreased, malaise, aspartate aminotransferase increased, vomiting on Jun 21, 2012 from JAPAN Additional patient health information: Female , 82 years of age, was diagnosed with
  • atrial fibrillation
and. Pradaxa dosage: 220 Mg.
Multiple prescriptions taken:
  • Verapamil Hcl
Patient was hospitalized.

Ear Haemorrhage, Headache (8476262-0)
Adverse event was reported on Jun 22, 2012 by a Male taking Pradaxa (Dosage: 150 Mg) was diagnosed with
  • arrhythmia
  • hypertension
and. Location: UNITED STATES , weighting 160.0 lb, After Pradaxa was administered, patient encountered several Pradaxa side effects: ear haemorrhage, headache.
Multiple concurrent drugs taken:
  • Nifedipine (30 Mg)
  • Enalipril (20 Mg)
  • Metoprolol Tartrate (25 Mg)
  • Simvastatin (20 Mg)


Cardiac Failure (8475620-8)
on Jun 20, 2012 Female from JAPAN , 88 years of age, weighting 132.3 lb, was diagnosed with
  • atrial fibrillation
and was treated with Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: cardiac failure. Pradaxa dosage: 220 Mg.
Associated medications used:
  • Mexitil (300 Mg)
  • Sigmart (15 Mg)
  • Lansoprazole (15 Mg)
Patient was hospitalized.


Deep Vein Thrombosis (8475491-X)
on Jun 21, 2012 Male from ARGENTINA , 76 years of age, was diagnosed with
  • thrombosis prophylaxis
and was treated with Pradaxa. Patient felt the following Pradaxa side effects: deep vein thrombosis. Pradaxa dosage: 220 Nr. Patient was hospitalized.

Cardiac Failure Congestive (8474879-0)
Patient was taking Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: cardiac failure congestive on Jun 20, 2012 from CANADA Additional patient health information: Male , 90 years of age, . Pradaxa dosage: 220 Mg.

Ischaemic Stroke (8474310-5)
Adverse event was reported on Jun 21, 2012 by a Male taking Pradaxa (Dosage: 150 Mg) was diagnosed with
  • atrial fibrillation
  • dyslipidaemia
and. Location: FRANCE , 63 years of age, Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: ischaemic stroke.
Associated medications used:
  • Simvastatin
  • Bisoprolol Fumarate (5 Mg)
  • Bisoprolol Fumarate (10 Mg)
  • Iperten
Patient was hospitalized.

Rectal Cancer, Rectal Haemorrhage (8474222-7)
on Jun 21, 2012 Male from AUSTRALIA , weighting 220.5 lb, was diagnosed with
  • atrial fibrillation
and was treated with Pradaxa. Patient felt the following Pradaxa side effects: rectal cancer, rectal haemorrhage. Pradaxa dosage: 220 Mg.
Multiple prescriptions taken:
  • Felodipine
  • Vitamin B-12
  • Irbesartan + Hydrochlorothiazide
  • Crestor
  • Acetaminophen
Patient was hospitalized.

Wound, Tongue Haemorrhage, Mouth Haemorrhage (8473329-8)
on Jun 19, 2012 Female from UNITED STATES , weighting 168.0 lb, was treated with Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: wound, tongue haemorrhage, mouth haemorrhage. Pradaxa dosage: N/A.

Embolic Stroke (8473068-3)
Patient was taking Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: embolic stroke on Jun 20, 2012 from JAPAN Additional patient health information: Male , 72 years of age, was diagnosed with
  • atrial fibrillation
and. Pradaxa dosage: N/A.

Dyspepsia, Cerebral Infarction (8472982-2)
Adverse event was reported on Jun 20, 2012 by a Female taking Pradaxa (Dosage: 220 Mg) . Location: JAPAN , 80 years of age, Patient felt the following Pradaxa side effects: dyspepsia, cerebral infarction. Patient was hospitalized.

Cerebrovascular Accident (8472907-X)
on Jun 20, 2012 Male from CANADA , 82 years of age, was diagnosed with
  • atrial fibrillation
and was treated with Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: cerebrovascular accident. Pradaxa dosage: 300 Mg.

Dehydration, Septic Shock (8472906-8)
on Jun 20, 2012 Female from UNITED STATES , 90 years of age, was treated with Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: dehydration, septic shock. Pradaxa dosage: N/A. Patient was hospitalized.

Diverticulitis, Diverticulum Intestinal Haemorrhagic (8472899-3)
Patient was taking Pradaxa. Patient felt the following Pradaxa side effects: diverticulitis, diverticulum intestinal haemorrhagic on Jun 20, 2012 from UNITED STATES Additional patient health information: Female , 62 years of age, was diagnosed with
  • atrial fibrillation
and. Pradaxa dosage: 300 Mg. Patient was hospitalized.

Cardiac Tamponade, Aortic Dissection, Chest Pain, Hypotension, Pericardial Effusion (8472888-9)
Adverse event was reported on Jun 22, 2012 by a Male taking Pradaxa (Dosage: Po) was diagnosed with
  • pulmonary embolism
  • deep vein thrombosis
and. Location: UNITED STATES , weighting 178.6 lb, After Pradaxa was administered, patient encountered several Pradaxa side effects: cardiac tamponade, aortic dissection, chest pain, hypotension, pericardial effusion.

Cardiac Failure (8472147-4)
on Jun 20, 2012 Female from JAPAN , weighting 88.18 lb, was diagnosed with
  • cerebrovascular accident prophylaxis
  • cardiac failure
and was treated with Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: cardiac failure. Pradaxa dosage: 220 Mg.
Associated medications used:
  • Diart (30 Mg)
  • Famotidine (20 Mg)
Patient was hospitalized.

Weight Decreased, Restlessness, Diarrhoea, Urine Abnormality, Sensation Of Pressure (8471240-X)
on Jun 21, 2012 Female from UNITED STATES , 91 years of age, was diagnosed with
  • atrial fibrillation
  • hypertension
and was treated with Pradaxa. Patient felt the following Pradaxa side effects: weight decreased, restlessness, diarrhoea, urine abnormality, sensation of pressure. Pradaxa dosage: 300 Mg.
Multiple prescriptions taken:
  • Furosemide (10 Mg)
  • Diltiazem Hydrocholoride (240 Mg)


Embolism (8471231-9)
Patient was taking Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: embolism on Jun 21, 2012 from GERMANY Additional patient health information: Male , 72 years of age, was diagnosed with
  • atrial fibrillation
and. Pradaxa dosage: N/A.

Insomnia, Feeling Abnormal, Cognitive Disorder (8471228-9)
Adverse event was reported on Jun 19, 2012 by a Female taking Pradaxa (Dosage: 220 Mg) was diagnosed with
  • thrombosis prophylaxis
  • arrhythmia
  • angina pectoris
and. Location: DENMARK , weighting 99.21 lb, Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: insomnia, feeling abnormal, cognitive disorder.
Associated medications used:
  • Digoxin
  • Isodur
  • Veraloc (Pharmaceutical Form: 245)


Transient Ischaemic Attack, Lateral Medullary Syndrome, Cerebral Infarction (8471040-0)
on Jun 19, 2012 Male from JAPAN , weighting 145.5 lb, was diagnosed with
  • atrial fibrillation
and was treated with Pradaxa. Patient felt the following Pradaxa side effects: transient ischaemic attack, lateral medullary syndrome, cerebral infarction. Pradaxa dosage: 220 Mg.
Multiple prescriptions taken:
  • Urso 250 (600 Mg)
  • Amlodipine (2.5 Mg)
  • Bisoprolol Fumarate (2.5 Mg)
  • Glycyron
  • Bepricor (150 Mg)
  • Olmetec (20 Mg)
Patient was hospitalized.

Fatigue, Nausea (8471039-4)
on Jun 18, 2012 Male from DENMARK , weighting 176.4 lb, was diagnosed with
  • atrial fibrillation
and was treated with Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: fatigue, nausea. Pradaxa dosage: 220 Mg.
Multiple concurrent drugs taken:
  • Metoprolol Succinate
  • Digoxin ^dak^
  • Tamsin
  • Valproic Acid
  • Citalopram Hydrobromide
Patient was hospitalized.

Cough, Abdominal Distension (8471035-7)
Patient was taking Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: cough, abdominal distension on Jun 21, 2012 from UNITED STATES Additional patient health information: Male , 81 years of age, was diagnosed with
  • atrial fibrillation
and. Pradaxa dosage: N/A.

Contusion, Insomnia (8470376-7)
Adverse event was reported on Jun 19, 2012 by a Female taking Pradaxa (Dosage: N/A) . Location: UNITED STATES , 81 years of age, Patient felt the following Pradaxa side effects: contusion, insomnia.

Photosensitivity Reaction (8470162-8)
on Jun 20, 2012 Male from UNITED STATES , 74 years of age, was treated with Pradaxa. After Pradaxa was administered, patient encountered several Pradaxa side effects: photosensitivity reaction. Pradaxa dosage: N/A.
Multiple concurrent drugs taken:
  • Hydrochlorothiazide


Cerebral Haemorrhage (8469847-9)
on Jun 19, 2012 Male from UNITED STATES , 72 years of age, was diagnosed with
  • atrial fibrillation
and was treated with Pradaxa. Directly after, patient experienced the unwanted or unexpected Pradaxa side effects: cerebral haemorrhage. Pradaxa dosage: 300 Mg. Patient was hospitalized.

Showing 1-25 of 6005 

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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.

Pradaxa Information

Alternative PRADAXA Names:DABIGATRA

Active Ingredient: DABIGATRA

More About Pradaxa

Side Effects reported to FDA: 6005. View Pradaxa Adverse Reports

Pradaxa safety alerts: 2012 2011

Reported deaths: 945

Reported hospitalizations: 2866

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]

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