PRADAXA
Pradaxa Adverse Events Reported to the FDA Over Time
How are Pradaxa adverse event reports trending over time?
This graph shows volume of adverse events submitted to the FDA by quarter for Pradaxa, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Pradaxa is flagged as the suspect drug causing the adverse event.
Most Common Pradaxa Adverse Events Reported to the FDA
What are the most common Pradaxa adverse events reported to the FDA?
| Gastrointestinal Haemorrhage | 2387 (3.47%) |
| Dyspepsia | 1442 (2.1%) |
| Dizziness | 1327 (1.93%) |
| Haemorrhage | 1287 (1.87%) |
| Cerebrovascular Accident | 1163 (1.69%) |
| Diarrhoea | 998 (1.45%) |
| Death | 976 (1.42%) |
| Headache | 934 (1.36%) |
| Rectal Haemorrhage | 916 (1.33%) |
| Nausea | 913 (1.33%) |
| Asthenia | 837 (1.22%) |
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This graph shows the top adverse events submitted to the FDA for Pradaxa, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Pradaxa is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.
Adverse Event Categories for Pradaxa
What are the most common Pradaxa adverse events reported to the FDA?
| Gastrointestinal Signs | 6754 (9.83%) |
| Gastrointestinal Hemorrhages | 5355 (7.79%) |
| Central Nervous System Vascular | 3329 (4.84%) |
| Neurological | 3075 (4.48%) |
| Hematology Investigations | 2509 (3.65%) |
| Respiratory | 2490 (3.62%) |
| Injuries | 2375 (3.46%) |
| Gastrointestinal Motility And Defec... | 1873 (2.73%) |
| Epidermal And Dermal Conditions | 1856 (2.7%) |
| Vascular Hemorrhagic | 1602 (2.33%) |
| Infections - Pathogen Unspecified | 1419 (2.07%) |
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Share/Embed Graph Export Data
This graph shows the top categories of adverse events submitted to the FDA for Pradaxa, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Pradaxa is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.
Common Uses of Pradaxa According to Those Reporting Adverse Events
Why are people taking Pradaxa, according to those reporting adverse events to the FDA?
| Atrial Fibrillation | 13905 |
| Cerebrovascular Accident Prophylaxi... | 1366 |
| Thrombosis Prophylaxis | 811 |
| Anticoagulant Therapy | 567 |
| Hip Arthroplasty | 269 |
| Knee Arthroplasty | 219 |
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Drug Labels
| Label | Labeler | Effective |
|---|---|---|
| Pradaxa | Rebel Distributors Corp | 23-NOV-10 |
| Pradaxa | Boehringer Ingelheim Pharmaceuticals Inc. | 04-JAN-13 |
| Pradaxa | Boehringer Ingelheim Pharmaceuticals Inc. | 26-APR-13 |
Pradaxa Case Reports
What Pradaxa safety concerns are being reported by doctors and researchers in the medical literature?
About Results
This report contains aggregated drug side effects and adverse events for Pradaxa. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.
DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.
DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.
Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.
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