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 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
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: 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 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 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 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
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 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 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 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 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 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
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
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
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
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