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Pradaxa (Dabigatran) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (996)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Pradaxa (Dabigatran) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 996   Next >>

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 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 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 physician from United States on 2012-08-27

Patient: female, weighing 44.9 kg (98.8 pounds)

Reactions: Haemoptysis, Spinal Fracture, Pulmonary Embolism, Pulmonary Infarction, Fall

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Digoxin; Zoloft; Lipitor; Dyazide; Bystolic



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

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 NEW Zealand on 2012-08-24

Patient: female, weighing 67.0 kg (147.4 pounds)

Reactions: Subdural Empyema, Wound Infection, Subdural Haemorrhage

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Inhibace; Bezalip Retard; Nicotinic Acid



Possible Pradaxa side effects in male

Reported by a physician from Germany on 2012-08-24

Patient: male, weighing 73.0 kg (160.6 pounds)

Reactions: Pneumonia, Shock Haemorrhagic, Toxicity To Various Agents, Haematemesis, Hypoxic-Ischaemic Encephalopathy, Disturbance in Attention, Melaena, Blood Pressure Decreased, Renal Failure Acute, Epistaxis

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Furosemide; Actraphane 30; Ramipril; Ferrous Sulfate TAB; Simva; Metoprolol Tartrate; Aspirin; Sitagliptin Phosphate; Actraphane 30; Spironolactone; Allopurinol; Tramadol HCL



Possible Pradaxa side effects in 78 year old male

Reported by a physician from Japan on 2012-08-24

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

Reactions: Intracardiac Thrombus

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Pradaxa

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



Possible Pradaxa side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female

Reactions: Haemoptysis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in 32 year old female

Reported by a physician from Brazil on 2012-08-24

Patient: 32 year old female

Reactions: Renal Failure, Hepatotoxicity, Septic Shock

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in 87 year old female

Reported by a physician from United States on 2012-08-24

Patient: 87 year old female, weighing 77.6 kg (170.6 pounds)

Reactions: Gastrointestinal Haemorrhage, International Normalised Ratio Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Plasmanate
    Dosage: 6 units intravenous
    Indication: Coagulopathy
    Start date: 2012-05-25
    End date: 2012-05-30

Pradaxa
    Dosage: one capsule twice a day by mouth
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2011-09-09
    End date: 2012-05-25



Possible Pradaxa side effects in male

Reported by a physician from Germany on 2012-08-24

Patient: male, weighing 85.0 kg (187.0 pounds)

Reactions: Gastrointestinal Haemorrhage, Pericardial Effusion, Renal Failure Acute

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Diclac
    Dosage: 50 mg

Pradaxa
    Dosage: 150 mg
    Indication: Atrial Fibrillation



Possible Pradaxa side effects in 80 year old female

Reported by a physician on 2012-08-24

Patient: 80 year old female, weighing 75.0 kg (165.0 pounds)

Reactions: Embolic Stroke

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in 63 year old male

Reported by a physician from Germany on 2012-08-24

Patient: 63 year old male

Reactions: Renal Failure, Melaena, Gastric Haemorrhage

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Diclofenac Sodium



Possible Pradaxa side effects in 76 year old male

Reported by a physician from Japan on 2012-08-24

Patient: 76 year old male, weighing 56.2 kg (123.6 pounds)

Reactions: Back Pain, Blood Creatine Phosphokinase Increased, Intestinal Polyp Haemorrhage, Sepsis, Muscular Weakness, Depressed Level of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Almarl; Cephadol; Lactec; Adona; Valsartan and Hydrochlorothiazide; Atelec; Ketas; Cefmetazon; Sunrythm



Possible Pradaxa side effects in 69 year old female

Reported by a pharmacist from United States on 2012-08-22

Patient: 69 year old female, weighing 72.6 kg (159.7 pounds)

Reactions: Epistaxis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in 84 year old female

Reported by a physician from France on 2012-08-22

Patient: 84 year old female

Reactions: Haemoglobin Decreased, RED Blood Cell Count Decreased, Rectal Haemorrhage, International Normalised Ratio Abnormal

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Coumadin
    Dosage: 1 df = two scored tablets daily
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-04-16
    End date: 2012-04-30

Pradaxa
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-05-01
    End date: 2012-05-02

Other drugs received by patient: Digoxin; Hyperium; Micardis; Amlodipine Besylate; Pravastatin; Lexomil; Polyethylene Glycol; Lansoprazole



Possible Pradaxa side effects in male

Reported by a physician from United States on 2012-08-21

Patient: male

Reactions: Subdural Haematoma, Mental Status Changes, Fall

Adverse event resulted in: life threatening event

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

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



Possible Pradaxa side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: female

Reactions: Subdural Haematoma, Head Injury, Skull Fracture, Fall

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in male

Reported by a pharmacist from Portugal on 2012-08-21

Patient: male, weighing 70.0 kg (154.0 pounds)

Reactions: Pruritus, Chills, Toxic Epidermal Necrolysis, Pyrexia, Odynophagia, Face Oedema, Rash Erythematous, Ocular Discomfort, Stevens-Johnson Syndrome

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Celecoxib
    Dosage: 200 mg
    Administration route: Oral
    Indication: Inflammation
    Start date: 2012-05-15
    End date: 2012-05-30

Metamizol
    Dosage: 2000mg/5ml
    Start date: 2012-05-11
    End date: 2012-05-14

Pradaxa
    Dosage: 150 mg
    Administration route: Oral
    Indication: Thrombosis Prophylaxis
    Start date: 2012-05-15
    End date: 2012-05-30

Sulfamethoxazole
    Dosage: 2 untit doses
    Administration route: Oral
    Indication: Infection Prophylaxis
    Start date: 2012-05-15
    End date: 2012-05-30

Other drugs received by patient: Tramadol HCL; Enoxaparin; Acetaminophen; Indapamide



Possible Pradaxa side effects in male

Reported by a physician from Germany on 2012-08-20

Patient: male

Reactions: Nausea, Cardiac Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in female

Reported by a physician from Portugal on 2012-08-20

Patient: female

Reactions: Haematochezia, Haemoglobin Decreased, Gastrointestinal Haemorrhage, Renal Impairment, Angina Pectoris, Anaemia, Angiodysplasia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Candesartan Cilexetil; Warfarin Sodium; Lercanidipine Hydrochoride; Rilmenidine; Allopurinol; Simvastatin; Furosemide; Propranolol Hydrochoride



Possible Pradaxa side effects in 74 year old female

Reported by a physician from Canada on 2012-08-17

Patient: 74 year old female

Reactions: Respiratory Failure, Cardiac Arrest, Epistaxis, Renal Failure Acute

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in

Reported by a physician from United States on 2012-08-17

Patient:

Reactions: Haemorrhage Intracranial

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in 69 year old male

Reported by a physician from Germany on 2012-08-17

Patient: 69 year old male, weighing 73.0 kg (160.6 pounds)

Reactions: Gastric Haemorrhage, Haematemesis

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Pradaxa



Possible Pradaxa side effects in female

Reported by a physician from Japan on 2012-08-17

Patient: female, weighing 38.9 kg (85.6 pounds)

Reactions: Pneumonia, Respiratory Failure, Haemoptysis, Anaemia, Pulmonary Alveolar Haemorrhage, Haematuria, Melaena, Epistaxis

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Miglitol; Digoxin; Diltiazem Hydrochloride; Losartan Potassium; Urso 250; Ganaton; Furosemide; BIO-Three



Possible Pradaxa side effects in female

Reported by a physician from NEW Zealand on 2012-08-17

Patient: female, weighing 73.0 kg (160.6 pounds)

Reactions: Left Ventricular Dysfunction, Chest Pain, Troponin Increased, Myocardial Infarction, Cardiovascular Disorder

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Flecainide Acetate
    Dosage: 200 mg
    Indication: Atrial Fibrillation
    Start date: 2012-03-23
    End date: 2012-04-03

Flecainide Acetate
    Indication: Atrial Flutter

Pradaxa
    Dosage: 300 mg
    Administration route: Oral
    Indication: Cerebrovascular Accident Prophylaxis
    Start date: 2012-02-24
    End date: 2012-04-03

Other drugs received by patient: Metoprolol Tartrate; Acetaminophen; CAL D-Forte; Atorvastatin



Possible Pradaxa side effects in 87 year old female

Reported by a physician from Japan on 2012-08-17

Patient: 87 year old female, weighing 53.0 kg (116.6 pounds)

Reactions: International Normalised Ratio Increased, Exsanguination, Melaena

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Omeprazole; Opaprosmon; TPN Electrolytes IN Plastic Container; Aldactone; Digoxin; Lasix; Nicoranta; Urso 250



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