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Pradaxa (Dabigatran) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Pradaxa (Dabigatran) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (11854)
Death (2398)
Life Threatening Events (996)
Disability (306)

Reports by Reaction Type

Gastrointestinal Haemorrhage (1284)Cerebrovascular Accident (702)Haemorrhage (638)Death (535)Fall (391)Dyspepsia (366)Rectal Haemorrhage (351)Dizziness (326)Melaena (321)Anaemia (286)Diarrhoea (286)Deep Vein Thrombosis (273)

Below are a few examples of reports where side effects / adverse reactions may be related to Pradaxa (Dabigatran). For a complete list or a specific selection of reports, please use the links above.

Possible Pradaxa side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Haemoptysis, Upper-Airway Cough Syndrome, Epistaxis

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Atorvastatin; Melatonin; Vitamin B Complex CAP; Clonazepam



Possible Pradaxa side effects in 78 year old

Reported by a physician from Belgium on 2012-08-27

Patient: 78 year old

Reactions: Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in 87 year old male

Reported by a physician from Australia on 2012-08-27

Patient: 87 year old male

Reactions: Cerebrovascular Accident

Adverse event resulted in: death

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Palpitations, Alopecia

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in male

Reported by a physician from Portugal on 2012-08-27

Patient: male

Reactions: Blood Disorder

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Acetylsalicylic Acid SRT



Possible Pradaxa side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Heart Rate Irregular

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Atenolol; Aspirin; Glimepiride; Lipitor; Triamterene and Hydrochlorothiazide; Multi-Vitamin; Fish OIL; Furosemide; Furosemide; Garlic; Iron; Actos; Enalapril Maleate



Possible Pradaxa side effects in male

Reported by a physician from United States on 2012-08-27

Patient: male

Reactions: Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Haemorrhage Intracranial

Adverse event resulted in: death

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in 82 year old male

Reported by a physician from France on 2012-08-27

Patient: 82 year old male

Reactions: Ischaemic Stroke

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in male

Reported by a physician from Australia on 2012-08-27

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Abdominal Pain, Renal Impairment, Nausea, Rectal Haemorrhage, Melaena, Decreased Appetite

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Allopurinol; Digoxin; Furosemide; Lipitor; Pantoprazole; Spironolactone; Spiriva; Cholecalciferol; Caltrate Vitamin D; Acetaminophen



Possible Pradaxa side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 68 year old female

Reactions: Ear Infection

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in 78 year old male

Reported by a physician from Japan on 2012-08-27

Patient: 78 year old male, weighing 54.5 kg (119.9 pounds)

Reactions: Drug Effect Decreased, Intracardiac Thrombus

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Rabeprazole Sodium; Phenytoin Sodium CAP



Possible Pradaxa side effects in

Reported by a physician from United States on 2012-08-27

Patient:

Reactions: Haemorrhagic Stroke

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in female

Reported by a physician from Japan on 2012-08-27

Patient: female, weighing 43.4 kg (95.5 pounds)

Reactions: Pneumonia, Putamen Haemorrhage

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Digoxin; Zolpidem



Possible Pradaxa side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: female

Reactions: Skin Exfoliation

Drug(s) suspected as cause:
Pradaxa
    Indication: Atrial Fibrillation

Pradaxa
    Dosage: 300 mg
    Administration route: Oral
    Indication: Cerebrovascular Accident Prophylaxis
    Start date: 2012-08-01
    End date: 2012-08-01



Possible Pradaxa side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Erythema of Eyelid, Skin Haemorrhage, Erythema

Drug(s) suspected as cause:
Pradaxa
    Dosage: 150 mg
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2011-02-01

Pradaxa
    Dosage: 75 mg
    Administration route: Oral

Other drugs received by patient: Lopressor



Possible Pradaxa side effects in female

Reported by a physician from Australia on 2012-08-27

Patient: female

Reactions: Colitis Ischaemic, Multi-Organ Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Pradaxa
    Indication: Cerebrovascular Accident Prophylaxis
    Start date: 2011-09-01
    End date: 2012-08-01

Pradaxa
    Indication: Atrial Fibrillation



Possible Pradaxa side effects in 86 year old male

Reported by a physician from Australia on 2012-08-27

Patient: 86 year old male

Reactions: Cardiac Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in male

Reported by a physician from France on 2012-08-27

Patient: male

Reactions: Myasthenia Gravis, Abasia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Vitamin B-12; Ramipril; Mytelase



Possible Pradaxa side effects in male

Reported by a physician from Japan on 2012-08-27

Patient: male, weighing 64.6 kg (142.1 pounds)

Reactions: Oesophageal Carcinoma, Gastrooesophageal Reflux Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Digoxin; Losartan Potassium and Hydrochlorothiazide; Rabeprazole Sodium



Possible Pradaxa side effects in

Reported by a physician from United States on 2012-08-27

Patient:

Reactions: Haemorrhagic Stroke

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in 80 year old female

Reported by a physician from United States on 2012-08-27

Patient: 80 year old female, weighing 52.2 kg (114.8 pounds)

Reactions: Dyspnoea, Gastrointestinal Haemorrhage, Abasia, Tremor, Fatigue, Chest Pain, Erosive Oesophagitis, Oesophageal Ulcer, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Levothyroxine Sodium; Paroxetine; Furosemide; Metolazone; Metolazone; Klor-CON; Lipitor; Ranitidine; Lisinopril; Amlodipine



Possible Pradaxa side effects in female

Reported by a physician from Luxembourg on 2012-08-27

Patient: female

Reactions: Vomiting

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in 80 year old female

Reported by a physician from Australia on 2012-08-27

Patient: 80 year old female

Reactions: Weight Decreased, Renal Failure, Lymphoma

Adverse event resulted in: death

Drug(s) suspected as cause:
Pradaxa
    Indication: Cerebrovascular Accident Prophylaxis
    Start date: 2011-08-16

Pradaxa
    Indication: Atrial Fibrillation



Possible Pradaxa side effects in 48 year old female

Reported by a consumer/non-health professional from India on 2012-08-27

Patient: 48 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in 79 year old female

Reported by a physician from Venezuela on 2012-08-27

Patient: 79 year old female, weighing 78.0 kg (171.6 pounds)

Reactions: Haemarthrosis, Cardiac Arrest, Haematoma

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Altase; Laxis; Digoxin; Lipitor



Possible Pradaxa side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in

Reported by a physician from United States on 2012-08-27

Patient:

Reactions: Ischaemic Stroke

Adverse event resulted in: death

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Abdominal Pain, Malaise, Diarrhoea, Nausea

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Crestor



Possible Pradaxa side effects in male

Reported by a physician from Australia on 2012-08-27

Patient: male

Reactions: Acute Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Pradaxa
    Indication: Atrial Fibrillation

Pradaxa
    Dosage: 220 mg
    Indication: Cerebrovascular Accident Prophylaxis
    Start date: 2011-10-13

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