Pradaxa Side Effects
How can Pradaxa Side Effects affect You? | PatientsVille.com
View and Submit Pradaxa Side Effects
Your Pradaxa Side Effect submission can play a very important role. Reporting your experience could help identify an unknown risk and inform other patients and health care professionals.
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.
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.
Alternative PRADAXA Names:DABIGATRA
Active Ingredient: DABIGATRA
Side Effects reported to FDA: 6005. View Pradaxa Adverse Reports
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.
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:
Pradaxa Adverse Reactions
Gastrointestinal Haemorrhage ( 679 Reports)|Cerebrovascular Accident ( 289 Reports)|Haemorrhage ( 282 Reports)|Dizziness ( 245 Reports)|Rectal Haemorrhage ( 236 Reports)|Dyspepsia ( 233 Reports)|Haemoglobin Decreased ( 187 Reports)|Fall ( 181 Reports)|Nausea ( 176 Reports)|Dyspnoea ( 172 Reports)|Death ( 171 Reports)|Asthenia ( 169 Reports)|Deep Vein Thrombosis ( 158 Reports)|Pulmonary Embolism ( 152 Reports)|Diarrhoea ( 151 Reports)|International Normalised Ratio Increased ( 148 Reports)|Headache ( 145 Reports)|Abdominal Pain Upper ( 142 Reports)|Anaemia ( 139 Reports)|Melaena ( 138 Reports)|Abdominal Discomfort ( 135 Reports)|Fatigue ( 135 Reports)|Chest Pain ( 123 Reports)|Haematochezia ( 121 Reports)|Renal Failure Acute ( 107 Reports)|Contusion ( 106 Reports)|Arthralgia ( 105 Reports)|Epistaxis ( 105 Reports)|Haematuria ( 104 Reports)|Oedema Peripheral ( 102 Reports)|