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Index of reports
> Cases with Gastrointestinal Haemorrhage (1284)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Pradaxa (Dabigatran) where reactions include gastrointestinal haemorrhage. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 1284 Next >>
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 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 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: 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 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 78 year old female
Reported by a physician from Germany on 2012-08-24
Patient: 78 year old female
Reactions: Death, Gastrointestinal Haemorrhage
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in male
Reported by a physician from United States on 2012-08-24
Patient: male
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Indication: Cerebrovascular Accident Prophylaxis
End date: 2012-08-01
Pradaxa
Indication: Atrial Fibrillation
Possible Pradaxa side effects in female
Reported by a physician from Japan on 2012-08-24
Patient: female
Reactions: Gastrointestinal Haemorrhage, Dehydration, Shock Haemorrhagic, Altered State of Consciousness, Acute Prerenal Failure
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aspirin
Administration route: Oral
End date: 2012-07-03
Pradaxa
Dosage: 220 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-02-01
End date: 2012-07-03
Verapamil HCL
Administration route: Oral
End date: 2012-07-03
Possible Pradaxa side effects in 98 year old female
Reported by a pharmacist from Japan on 2012-08-24
Patient: 98 year old female
Reactions: Death, Gastrointestinal Haemorrhage, Melaena
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Furosemide; Allopurinol
Possible Pradaxa side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: male
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in 76 year old female
Reported by a pharmacist from United States on 2012-08-24
Patient: 76 year old female, weighing 84.0 kg (184.8 pounds)
Reactions: Gastrointestinal Haemorrhage, Cardiac Arrest, Haematemesis
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 2012-08-24
Patient: male
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Pradaxa
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 female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: female
Reactions: Gastrointestinal Haemorrhage
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 2012-08-23
Patient: female
Reactions: Gastrointestinal Haemorrhage
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 2012-08-23
Patient: female
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in 84 year old female
Reported by a pharmacist from United States on 2012-08-22
Patient: 84 year old female
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Gabapentin; Diovan; Nexium; Lansoprazole; Tekturna; Pravastatin; Coreg; Synthroid; Imdur; Zolpidem; Aricept; Digoxin
Possible Pradaxa side effects in male
Reported by a physician from United States on 2012-08-22
Patient: male
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Dosage: 300 mg
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-01-01
End date: 2012-05-25
Pradaxa
Indication: Atrial Fibrillation
Other drugs received by patient: Allopurinol; Metoprolol Tartrate; Crestor; Lisinopril
Possible Pradaxa side effects in female
Reported by a physician from United States on 2012-08-22
Patient: female
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: male
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in 88 year old female
Reported by a physician from United States on 2012-08-22
Patient: 88 year old female
Reactions: Gastrointestinal Haemorrhage
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 2012-08-22
Patient: female
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 United States on 2012-08-22
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 United States on 2012-08-22
Patient: male
Reactions: Gastrointestinal Haemorrhage
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 2012-08-21
Patient: female
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in 84 year old male
Reported by a pharmacist from United States on 2012-08-21
Patient: 84 year old male
Reactions: Gastrointestinal Haemorrhage, Oedema Peripheral
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 2012-08-21
Patient: female
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Dosage: 150 mg
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
End date: 2012-08-01
Pradaxa
Administration route: Oral
Indication: Atrial Fibrillation
Possible Pradaxa side effects in
Reported by a physician from United States on 2012-08-21
Patient:
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 United States on 2012-08-21
Patient: male
Reactions: Gastrointestinal Haemorrhage
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 2012-08-20
Patient: female
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
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