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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 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 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 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 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 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 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 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



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

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 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 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 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 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

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 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 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

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