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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: 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 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: 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 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 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 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 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 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 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 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 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 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 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 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: Haemorrhage

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

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

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