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> All Cases (11854)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Pradaxa (Dabigatran) all cases. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 11854 Next >>
Possible Pradaxa side effects in male
Reported by a physician from Australia on 2012-08-27
Patient: male
Reactions: Cardiac Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in 89 year old female
Reported by a physician from Austria on 2012-08-27
Patient: 89 year old female, weighing 70.0 kg (154.0 pounds)
Reactions: Haemothorax, RIB Fracture
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Aspirin
Dosage: 100 mg
Pradaxa
Dosage: 220 mg
Indication: Atrial Fibrillation
Possible Pradaxa side effects in
Reported by a physician from United States on 2012-08-27
Patient:
Reactions: Haemorrhage, Pleural Effusion
Adverse event resulted in: death, hospitalization
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: Haemoglobin Decreased, Frequent Bowel Movements, Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Dosage: 300 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2011-10-02
End date: 2011-11-16
Pradaxa
Indication: Anticoagulant Therapy
Other drugs received by patient: Multi-Vitamins; Vitamin B-12; Synthroid; Lyrica
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 female
Reported by a physician from United States on 2012-08-27
Patient: female, weighing 64.0 kg (140.8 pounds)
Reactions: Anorectal Discomfort, Constipation, Proctalgia
Drug(s) suspected as cause:
Pradaxa
Indication: Atrial Fibrillation
Pradaxa
Dosage: 300 mg
Administration route: Oral
Indication: Anticoagulant Therapy
Start date: 2011-01-01
Other drugs received by patient: Metoprolol Tartrate; Tylenol; Citalopram Hydrobromide; Estrace; Levoxyl; Metoprolol Tartrate; Citalopram Hydrobromide; Levthyroxine; Lipitor; Pepcid
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 male
Reported by a physician from Australia on 2012-08-27
Patient: male
Reactions: Respiratory Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Pradaxa
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2011-08-05
Pradaxa
Indication: Atrial Fibrillation
Possible Pradaxa side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Blood Pressure Decreased
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Tramadol HCL; Tylenol; Diovan; Synthroid; Metoprolol Tartrate
Possible Pradaxa side effects in 73 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 73 year old male
Reactions: Haematochezia, Burning Sensation, Cellulitis, Contusion, Haemorrhage
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Lasix; Ranitidine
Possible Pradaxa side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in 82 year old male
Reported by a physician from Philippines on 2012-08-27
Patient: 82 year old male
Reactions: Cerebrovascular Accident
Adverse event resulted in: death
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Nitrate; Symbicort; Calcium Channel Blocker; Micardis
Possible Pradaxa side effects in male
Reported by a physician from Australia on 2012-08-27
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Pradaxa
Indication: Atrial Fibrillation
Pradaxa
Dosage: 220 mg
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2011-08-25
Possible Pradaxa side effects in female
Reported by a physician from Australia on 2012-08-27
Patient: female, weighing 55.0 kg (121.0 pounds)
Reactions: Renal Failure, Dementia
Adverse event resulted in: death
Drug(s) suspected as cause:
Pradaxa
Dosage: 220 mg
Indication: Cerebrovascular Accident Prophylaxis
Pradaxa
Indication: Atrial Fibrillation
Possible Pradaxa side effects in male
Reported by a physician from Denmark on 2012-08-27
Patient: male, weighing 75.0 kg (165.0 pounds)
Reactions: Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in 77 year old female
Reported by a pharmacist from Japan on 2012-08-27
Patient: 77 year old female
Reactions: Agranulocytosis, Leukopenia
Adverse event resulted in: hospitalization
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, 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 male
Reported by a physician from United States on 2012-08-27
Patient: male
Reactions: Rectal Cancer
Adverse event resulted in: death
Drug(s) suspected as cause:
Pradaxa
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 91 year old female
Reported by a physician from United States on 2012-08-27
Patient: 91 year old female
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Diltiazem; Amiodarone HCL; Bactrim
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 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 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 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 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 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
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