| Drug Report: PRADAXA (DABIGATRAN ETEXILATE MESYLATE) | ||||||||
| Primary Suspect Reports: 18,509 Total Reports: 19,359 FDA AERS Reports from 11/01/1997 to 08/27/2012 | ||||||||
| Drug Description : | ||||||||
Pradaxa (dabigatran etexilate mesylate) is a direct thrombin inhibitor indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. Manufactured by Boehringer Ingelheim, Pradaxa was FDA approved on October 19, 2010. |
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| Drug Safety Monitor News : | ||||||||
05/02/2013 - Pradaxa to Carry Black Box Warning: Treatment Discontinuation Increases Risk of Stroke |
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| Other Names : | Generic Name : | Report Info: | ||||||
Rendix, BIBR 1048, Dabigatran Etexilate |
DABIGATRAN ETEXILATE MESYLATE | Average Age: 75 Years |
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FDA Listed Names (126) :
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Manufacturer: | Common Conditions: | ||||||
Bibr 1048 |
Boehringer Ingelheim GmbH (16,957) |
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| Top PRADAXA Adverse Events/Side Effects |
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| Side Effects MedDRA Preferred Terms |
PRADAXA Primary Suspect Reports | PRADAXA Total Reports |
ROR Score
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PRR Score
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Compare Top Drugs |
| Gastrointestinal Haemorrhage | 1,826 (10%) | 1,873 (10%) | Premium Feature | Premium Feature |
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| Dyspepsia | 965 (5%) | 974 (5%) | Premium Feature | Premium Feature |
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| Haemorrhage | 955 (5%) | 979 (5%) | Premium Feature | Premium Feature |
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| Dizziness | 863 (5%) | 890 (5%) | Premium Feature | Premium Feature |
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| Cerebrovascular Accident | 840 (5%) | 861 (4%) | Premium Feature | Premium Feature |
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| Headache | 623 (3%) | 650 (3%) | Premium Feature | Premium Feature |
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| Diarrhoea | 617 (3%) | 652 (3%) | Premium Feature | Premium Feature |
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| Rectal Haemorrhage | 606 (3%) | 632 (3%) | Premium Feature | Premium Feature |
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| Death | 603 (3%) | 626 (3%) | Premium Feature | Premium Feature |
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| Nausea | 587 (3%) | 629 (3%) | Premium Feature | Premium Feature |
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| Reported Report Outcomes for PRADAXA Adverse Events |
| Report Outcomes |
PRADAXA Primary Suspect (# of Reports) (11/01/1997 to 08/27/2012) |
PRADAXA Total (# of Reports) (11/01/1997 to 08/27/2012) |
| Hospitalization - Initial or Prolonged | 6,879 (37%) | 7,295 (38%) |
| Other | 3,059 (17%) | 3,387 (18%) |
| Death | 2,081 (11%) | 2,175 (11%) |
| Life-Threatening | 1,172 (6%) | 1,223 (6%) |
| Disability | 357 (2%) | 374 (2%) |
| Required Intervention to Prevent Permanent Impairment/Damage | 95 (1%) | 107 (1%) |
| Congenital Anomaly | 2 (0%) | 2 (0%) |
| Most Recent PRADAXA Report Reviews/FDA Reports (Primary Suspect) |
| Report Date | Age | Gender | Conditions | Adverse Events | Outcome |
| 08/27/2012 | 66 YR | F |
Anxiety Atrial Fibrillation Blood Cholesterol Abnormal Show All |
Haemoptysis Epistaxis Upper-airway Cough Syndrome |
Not Stated |
| 08/27/2012 | Not Stated | F |
Atrial Fibrillation Cerebrovascular Accident Prophylaxis |
Skin Exfoliation |
Not Stated |
| 08/27/2012 | 91 YR | F |
Arrhythmia Atrial Fibrillation Urinary Tract Infection |
Gastrointestinal Haemorrhage |
Death |
| 08/27/2012 | Not Stated | M |
Atrial Fibrillation |
Haemorrhage |
Death |
| 08/27/2012 | 82 YR | M |
Cerebrovascular Accident Prophylaxis Chronic Obstructive Pulmonary Disease Hypertension |
Cerebrovascular Accident |
Death |
| 08/27/2012 | 79 YR | F |
Atrial Fibrillation |
Haemarthrosis Cardiac Arrest Haematoma |
Death Hospitalization - Initial or Prolonged |
| 08/27/2012 | Not Stated | M |
Atrial Fibrillation |
Blood Disorder |
Life-Threatening |
| 08/27/2012 | Not Stated | M |
Atrial Fibrillation |
Abasia Myasthenia Gravis |
Disability Other |
| 08/27/2012 | 89 YR | F |
Atrial Fibrillation |
Rib Fracture Haemothorax |
Death Hospitalization - Initial or Prolonged |
| 08/27/2012 | 71 YR | M |
Atrial Fibrillation Cerebrovascular Accident Prophylaxis Gout Show All |
Aortic Aneurysm |
Death |
