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DABIGATRAN ETEXILATE

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Dabigatran Etexilate Adverse Events Reported to the FDA Over Time

How are Dabigatran Etexilate adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Dabigatran Etexilate, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Dabigatran Etexilate is flagged as the suspect drug causing the adverse event.

Most Common Dabigatran Etexilate Adverse Events Reported to the FDA

What are the most common Dabigatran Etexilate adverse events reported to the FDA?

Gastrointestinal Haemorrhage
2435 (3.49%)
Dyspepsia
1442 (2.07%)
Dizziness
1329 (1.9%)
Haemorrhage
1293 (1.85%)
Cerebrovascular Accident
1166 (1.67%)
Diarrhoea
1005 (1.44%)
Death
986 (1.41%)
Headache
936 (1.34%)
Rectal Haemorrhage
927 (1.33%)
Nausea
916 (1.31%)
Dyspnoea
853 (1.22%)
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Asthenia
846 (1.21%)
Abdominal Discomfort
785 (1.12%)
Fatigue
776 (1.11%)
Abdominal Pain Upper
759 (1.09%)
Fall
759 (1.09%)
Contusion
683 (.98%)
Oedema Peripheral
682 (.98%)
Melaena
635 (.91%)
International Normalised Ratio Incr...
632 (.91%)
Chest Pain
615 (.88%)
Epistaxis
607 (.87%)
Deep Vein Thrombosis
594 (.85%)
Arthralgia
582 (.83%)
Anaemia
543 (.78%)
Flatulence
515 (.74%)
Haematochezia
492 (.7%)
Haemoglobin Decreased
492 (.7%)
Pulmonary Embolism
487 (.7%)
Haematuria
446 (.64%)
Renal Failure Acute
443 (.63%)
Vomiting
434 (.62%)
Pruritus
411 (.59%)
Pain In Extremity
406 (.58%)
Renal Failure
399 (.57%)
Malaise
383 (.55%)
Haemorrhage Intracranial
373 (.53%)
Abdominal Pain
351 (.5%)
Transient Ischaemic Attack
340 (.49%)
Constipation
335 (.48%)
Dysphagia
329 (.47%)
Gastrooesophageal Reflux Disease
329 (.47%)
Pain
327 (.47%)
Atrial Fibrillation
322 (.46%)
Rash
319 (.46%)
Myocardial Infarction
317 (.45%)
Renal Impairment
316 (.45%)
Decreased Appetite
315 (.45%)
Ischaemic Stroke
313 (.45%)
Blood Urine Present
311 (.45%)
Cerebral Haemorrhage
310 (.44%)
Pneumonia
306 (.44%)
Joint Swelling
305 (.44%)
Cerebral Infarction
300 (.43%)
Chest Discomfort
300 (.43%)
Activated Partial Thromboplastin Ti...
298 (.43%)
Hypotension
298 (.43%)
Insomnia
281 (.4%)
Throat Irritation
280 (.4%)
Back Pain
273 (.39%)
Weight Decreased
257 (.37%)
Cough
244 (.35%)
Haematoma
242 (.35%)
Feeling Abnormal
237 (.34%)
Haemoptysis
235 (.34%)
Abdominal Distension
232 (.33%)
Oesophageal Pain
228 (.33%)
Eructation
227 (.33%)
Drug Ineffective
225 (.32%)
Cardiac Failure Congestive
206 (.3%)
Subdural Haematoma
198 (.28%)
Urinary Tract Infection
195 (.28%)
Gingival Bleeding
194 (.28%)
Cardiac Failure
193 (.28%)
Alopecia
192 (.27%)
Myalgia
192 (.27%)
Lower Gastrointestinal Haemorrhage
189 (.27%)
Thrombosis
189 (.27%)
Dehydration
187 (.27%)
Pyrexia
185 (.26%)
Oropharyngeal Pain
184 (.26%)
Haematemesis
181 (.26%)
Faeces Discoloured
180 (.26%)
Upper Gastrointestinal Haemorrhage
180 (.26%)
Muscle Spasms
177 (.25%)
Sepsis
169 (.24%)
Gait Disturbance
168 (.24%)
Blood Creatinine Increased
164 (.23%)
Coagulopathy
164 (.23%)
Erythema
164 (.23%)
Heart Rate Increased
161 (.23%)
Sensation Of Foreign Body
161 (.23%)
Haemorrhoidal Haemorrhage
157 (.22%)
Wound Secretion
155 (.22%)
Confusional State
154 (.22%)
Gastritis
154 (.22%)
Haemorrhoids
154 (.22%)
Syncope
145 (.21%)
Hypertension
142 (.2%)
Blood Pressure Increased
141 (.2%)
Somnolence
141 (.2%)

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This graph shows the top adverse events submitted to the FDA for Dabigatran Etexilate, 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 Dabigatran Etexilate 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 Dabigatran Etexilate

What are the most common Dabigatran Etexilate adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Dabigatran Etexilate, 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 Dabigatran Etexilate 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 Dabigatran Etexilate According to Those Reporting Adverse Events

Why are people taking Dabigatran Etexilate, according to those reporting adverse events to the FDA?

Atrial Fibrillation
13969
Cerebrovascular Accident Prophylaxi...
1410
Thrombosis Prophylaxis
933
Anticoagulant Therapy
581
Hip Arthroplasty
272
Knee Arthroplasty
220
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Cerebrovascular Accident
163
Atrial Flutter
142
Prophylaxis
128
Deep Vein Thrombosis
105
Thrombosis
98
Cardiac Disorder
73
Product Used For Unknown Indication
70
Heart Rate Irregular
64
Pulmonary Embolism
63
Transient Ischaemic Attack
55
Drug Therapy Changed
54
Arrhythmia
53
Joint Arthroplasty
45
Coagulopathy
28
Embolism Venous
27
Cerebral Infarction
24
Cardiac Failure Congestive
21
Hypertension
20
Embolic Stroke
20
Orthopedic Procedure
20
Heart Valve Replacement
18
Embolism
17
Cardiac Fibrillation
15
Knee Operation
15
Cardiovascular Event Prophylaxis
15
Cardiac Valve Disease
15
Aortic Valve Replacement
14
Heart Rate Increased
14
Cardiac Pacemaker Insertion
14
Cardiac Ablation
13
Cardiac Assistance Device User
13
Tachyarrhythmia
12
Cardiac Valve Prosthesis User
10
Hip Surgery
10
Congestive Cardiomyopathy
9
Supraventricular Tachycardia
8
Myocardial Infarction
8
Ill-defined Disorder
8
Postoperative Care
8
Coronary Arterial Stent Insertion
8
Cardiac Murmur
8
Protein S Deficiency
7
Limb Immobilisation
7
Stent Placement
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

Dabigatran Etexilate Case Reports

What Dabigatran Etexilate 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 Dabigatran Etexilate. 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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