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PRADAXA

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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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Dyspnoea
836 (1.22%)
Abdominal Discomfort
782 (1.14%)
Fatigue
773 (1.12%)
Abdominal Pain Upper
752 (1.09%)
Fall
748 (1.09%)
Contusion
683 (.99%)
Oedema Peripheral
680 (.99%)
Melaena
632 (.92%)
International Normalised Ratio Incr...
624 (.91%)
Chest Pain
610 (.89%)
Epistaxis
598 (.87%)
Arthralgia
582 (.85%)
Deep Vein Thrombosis
556 (.81%)
Anaemia
531 (.77%)
Flatulence
515 (.75%)
Haematochezia
487 (.71%)
Haemoglobin Decreased
479 (.7%)
Pulmonary Embolism
460 (.67%)
Haematuria
442 (.64%)
Vomiting
429 (.62%)
Pruritus
410 (.6%)
Renal Failure Acute
406 (.59%)
Pain In Extremity
404 (.59%)
Renal Failure
387 (.56%)
Malaise
379 (.55%)
Haemorrhage Intracranial
364 (.53%)
Abdominal Pain
348 (.51%)
Transient Ischaemic Attack
338 (.49%)
Constipation
335 (.49%)
Dysphagia
329 (.48%)
Gastrooesophageal Reflux Disease
326 (.47%)
Pain
324 (.47%)
Rash
319 (.46%)
Myocardial Infarction
314 (.46%)
Renal Impairment
314 (.46%)
Decreased Appetite
313 (.46%)
Blood Urine Present
311 (.45%)
Ischaemic Stroke
308 (.45%)
Cerebral Haemorrhage
305 (.44%)
Joint Swelling
305 (.44%)
Atrial Fibrillation
302 (.44%)
Chest Discomfort
296 (.43%)
Pneumonia
295 (.43%)
Activated Partial Thromboplastin Ti...
291 (.42%)
Cerebral Infarction
290 (.42%)
Insomnia
281 (.41%)
Throat Irritation
280 (.41%)
Back Pain
273 (.4%)
Hypotension
263 (.38%)
Weight Decreased
256 (.37%)
Cough
242 (.35%)
Feeling Abnormal
237 (.34%)
Haematoma
236 (.34%)
Haemoptysis
229 (.33%)
Oesophageal Pain
228 (.33%)
Eructation
227 (.33%)
Abdominal Distension
226 (.33%)
Drug Ineffective
224 (.33%)
Subdural Haematoma
197 (.29%)
Cardiac Failure Congestive
195 (.28%)
Cardiac Failure
193 (.28%)
Alopecia
192 (.28%)
Myalgia
192 (.28%)
Gingival Bleeding
189 (.28%)
Lower Gastrointestinal Haemorrhage
189 (.28%)
Urinary Tract Infection
187 (.27%)
Oropharyngeal Pain
184 (.27%)
Dehydration
183 (.27%)
Thrombosis
182 (.26%)
Faeces Discoloured
180 (.26%)
Pyrexia
178 (.26%)
Haematemesis
177 (.26%)
Muscle Spasms
177 (.26%)
Upper Gastrointestinal Haemorrhage
177 (.26%)
Sepsis
169 (.25%)
Gait Disturbance
168 (.24%)
Erythema
164 (.24%)
Sensation Of Foreign Body
161 (.23%)
Heart Rate Increased
159 (.23%)
Haemorrhoidal Haemorrhage
157 (.23%)
Gastritis
154 (.22%)
Blood Creatinine Increased
152 (.22%)
Confusional State
151 (.22%)
Haemorrhoids
151 (.22%)
Coagulopathy
149 (.22%)
Wound Secretion
149 (.22%)
Hypertension
141 (.21%)
Shock Haemorrhagic
139 (.2%)
Blood Pressure Increased
138 (.2%)
Embolic Stroke
138 (.2%)

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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?

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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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Cerebrovascular Accident
161
Atrial Flutter
142
Prophylaxis
121
Deep Vein Thrombosis
102
Thrombosis
95
Cardiac Disorder
72
Product Used For Unknown Indication
66
Heart Rate Irregular
64
Pulmonary Embolism
62
Transient Ischaemic Attack
55
Drug Therapy Changed
54
Arrhythmia
50
Joint Arthroplasty
45
Coagulopathy
26
Embolism Venous
25
Cerebral Infarction
24
Cardiac Failure Congestive
21
Orthopedic Procedure
20
Hypertension
20
Heart Valve Replacement
18
Embolic Stroke
16
Embolism
16
Cardiovascular Event Prophylaxis
15
Knee Operation
15
Cardiac Valve Disease
15
Cardiac Fibrillation
15
Aortic Valve Replacement
14
Cardiac Pacemaker Insertion
14
Heart Rate Increased
14
Cardiac Assistance Device User
13
Cardiac Ablation
13
Tachyarrhythmia
12
Hip Surgery
10
Cardiac Valve Prosthesis User
10
Congestive Cardiomyopathy
9
Postoperative Care
8
Supraventricular Tachycardia
8
Cardiac Murmur
8
Myocardial Infarction
8
Coronary Arterial Stent Insertion
8
Limb Immobilisation
7
Stent Placement
7
Mitral Valve Replacement
7
Protein S Deficiency
7
Coronary Artery Disease
7

Drug Labels

LabelLabelerEffective
PradaxaRebel Distributors Corp23-NOV-10
PradaxaBoehringer Ingelheim Pharmaceuticals Inc.04-JAN-13
PradaxaBoehringer Ingelheim Pharmaceuticals Inc.26-APR-13

Pradaxa Case Reports

What Pradaxa safety concerns are being reported by doctors and researchers in the medical literature?

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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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