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Index of reports
> Cases with Melaena (321)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Pradaxa (Dabigatran) where reactions include melaena. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 321 Next >>
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 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 63 year old male
Reported by a physician from Germany on 2012-08-24
Patient: 63 year old male
Reactions: Renal Failure, Melaena, Gastric Haemorrhage
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Diclofenac Sodium
Possible Pradaxa side effects in male
Reported by a physician from Germany on 2012-08-24
Patient: male, weighing 73.0 kg (160.6 pounds)
Reactions: Pneumonia, Shock Haemorrhagic, Toxicity To Various Agents, Haematemesis, Hypoxic-Ischaemic Encephalopathy, Disturbance in Attention, Melaena, Blood Pressure Decreased, Renal Failure Acute, Epistaxis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Furosemide; Actraphane 30; Ramipril; Ferrous Sulfate TAB; Simva; Metoprolol Tartrate; Aspirin; Sitagliptin Phosphate; Actraphane 30; Spironolactone; Allopurinol; Tramadol HCL
Possible Pradaxa side effects in 73 year old female
Reported by a health professional (non-physician/pharmacist) from NEW Zealand on 2012-08-21
Patient: 73 year old female
Reactions: Confusional State, Haematuria, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Furosemide; Candesartan Cilexetil; Simvastatin; Metformin
Possible Pradaxa side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from NEW Zealand on 2012-08-21
Patient: 75 year old male
Reactions: Renal Failure, Gastritis Erosive, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aspirin
Dosage: 300 mg
Administration route: Oral
Indication: Myocardial Ischaemia
End date: 2012-03-29
Pradaxa
Dosage: 300 mg
Administration route: Oral
Indication: Atrial Fibrillation
End date: 2012-03-29
Pradaxa
Indication: Atrial Flutter
Other drugs received by patient: Atorvastatin; Furosemide; Amiodarone HCL
Possible Pradaxa side effects in 87 year old female
Reported by a physician from Japan on 2012-08-17
Patient: 87 year old female, weighing 53.0 kg (116.6 pounds)
Reactions: International Normalised Ratio Increased, Exsanguination, Melaena
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Omeprazole; Opaprosmon; TPN Electrolytes IN Plastic Container; Aldactone; Digoxin; Lasix; Nicoranta; Urso 250
Possible Pradaxa side effects in 77 year old male
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: 77 year old male
Reactions: Haemoglobin Decreased, Upper Gastrointestinal Haemorrhage, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Lisinopril; Colace; Fenofibrate; Gabapentin; Allopurinol; Celebrex; Calcium; Glipizide; Omeprazole; Bumex; Simvastatin
Possible Pradaxa side effects in
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-17
Patient:
Reactions: Cardio-Respiratory Arrest, Haemorrhage, Melaena
Adverse event resulted in: death
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in female
Reported by a physician from Japan on 2012-08-17
Patient: female, weighing 38.9 kg (85.6 pounds)
Reactions: Pneumonia, Respiratory Failure, Haemoptysis, Anaemia, Pulmonary Alveolar Haemorrhage, Haematuria, Melaena, Epistaxis
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Miglitol; Digoxin; Diltiazem Hydrochloride; Losartan Potassium; Urso 250; Ganaton; Furosemide; BIO-Three
Possible Pradaxa side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-08
Patient: female
Reactions: Malaise, Normochromic Normocytic Anaemia, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in 79 year old male
Reported by a physician from Germany on 2012-08-06
Patient: 79 year old male
Reactions: Heart Rate, Blood Pressure Decreased, Melaena, Renal Failure Acute, Haematemesis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in female
Reported by a physician from Portugal on 2012-08-03
Patient: female, weighing 46.0 kg (101.2 pounds)
Reactions: Renal Impairment, Presyncope, Anaemia, Melaena, Gastric Haemorrhage
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Amiodarone HCL
Dosage: 200 mg
Administration route: Oral
Indication: Cardiac Failure Congestive
Pradaxa
Dosage: 150 mg
Administration route: Oral
Indication: Thrombosis Prophylaxis
Start date: 2011-05-18
Pradaxa
Indication: Atrial Fibrillation
Other drugs received by patient: Peridonpril 2 MG; Furosemide; Nitroglycerin 10mg / 24H; Spironolactone; Digoxin
Possible Pradaxa side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-01
Patient: female
Reactions: Malaise, Anaemia, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in female
Reported by a physician from Germany on 2012-07-30
Patient: female
Reactions: Anaemia, Pulmonary Embolism, Melaena
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Analgesics
Possible Pradaxa side effects in 71 year old male
Reported by a physician from Brazil on 2012-07-27
Patient: 71 year old male
Reactions: Gastrointestinal Haemorrhage, Anaemia, Orthostatic Hypotension, Melaena
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in male
Reported by a physician from Japan on 2012-07-27
Patient: male, weighing 66.0 kg (145.2 pounds)
Reactions: Renal Impairment, Melaena, Gastric Ulcer
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Diovan; Inderal; Digoxin; Coniel
Possible Pradaxa side effects in female
Reported by a physician from Portugal on 2012-07-27
Patient: female, weighing 46.0 kg (101.2 pounds)
Reactions: Renal Impairment, Anaemia, Presyncope, Gastric Haemorrhage, Melaena
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Amiodarone Hydrochloride
Dosage: 171.4286 mg
Administration route: Oral
Indication: Cardiac Failure Congestive
Pradaxa
Indication: Atrial Fibrillation
Pradaxa
Dosage: 150 mg
Administration route: Oral
Indication: Thrombosis Prophylaxis
Start date: 2011-05-18
Other drugs received by patient: Spironolactone; Peridonpril 2 MG; Furosemide; Digoxin
Possible Pradaxa side effects in female
Reported by a physician from Portugal on 2012-07-24
Patient: female, weighing 46.0 kg (101.2 pounds)
Reactions: Renal Impairment, Anaemia, Presyncope, Melaena, Gastric Haemorrhage
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Amiodarone Hydrochloride
Dosage: 171.4286 mg
Administration route: Oral
Indication: Cardiac Failure Congestive
Pradaxa
Indication: Atrial Fibrillation
Pradaxa
Dosage: 150 mg
Administration route: Oral
Indication: Thrombosis Prophylaxis
Start date: 2011-05-18
Other drugs received by patient: Peridonpril 2 MG; Digoxin; Spironolactone; Furosemide
Possible Pradaxa side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-20
Patient: male
Reactions: Pain in Extremity, Musculoskeletal Pain, Lipohypertrophy, Myalgia, Dyspepsia, Joint Swelling, Insomnia, Heart Rate Increased, Oedema Peripheral, Ulcer Haemorrhage, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Celebrex
Indication: Pain
Start date: 2012-04-01
Pradaxa
Dosage: 300 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2011-12-28
Other drugs received by patient: Metoprolol Succinate
Possible Pradaxa side effects in 97 year old female
Reported by a pharmacist from Japan on 2012-07-19
Patient: 97 year old female, weighing 36.5 kg (80.3 pounds)
Reactions: Diverticulum Intestinal, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Ferrous Fumarate; Uritos; Lansoprazole
Possible Pradaxa side effects in female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-07-17
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Nausea, Diarrhoea, Malnutrition, Melaena, Decreased Appetite
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Furosemide; Simvastatin; Enalapril Maleate; Sertraline Hydrochloride; Acetaminophen
Possible Pradaxa side effects in female
Reported by a physician from Israel on 2012-07-17
Patient: female
Reactions: Gastrointestinal Haemorrhage, Melaena, Haematemesis
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in male
Reported by a physician from Denmark on 2012-07-17
Patient: male, weighing 80.0 kg (176.0 pounds)
Reactions: Sepsis, Haematuria, Melaena, Cerebral Haemorrhage, Renal Failure Acute
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Digoxin; Metformin ^actavis^; Metoprolol Succinate
Possible Pradaxa side effects in male
Reported by a physician from United States on 2012-07-12
Patient: male, weighing 93.0 kg (204.6 pounds)
Reactions: Pruritus, Dyspnoea, Melaena, Constipation
Drug(s) suspected as cause:
Pradaxa
Dosage: 300 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-06-08
End date: 2012-06-11
Pradaxa
Dosage: 150 mg
Administration route: Oral
Start date: 2012-06-12
Other drugs received by patient: Oxycontin; Valium
Possible Pradaxa side effects in female
Reported by a physician from Israel on 2012-07-11
Patient: female
Reactions: Melaena, Haematemesis
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in 72 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-06
Patient: 72 year old male
Reactions: Gastrointestinal Haemorrhage, Melaena
Adverse event resulted in: death
Drug(s) suspected as cause:
Pradaxa
Dosage: 110 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-06-14
End date: 2012-06-21
Pradaxa
Indication: Cardiovascular Event Prophylaxis
Other drugs received by patient: Zebeta; Quinine Sulfate; Senna-Mint WAF; Simvastatin; Lactulose; Warfarin Sodium
Possible Pradaxa side effects in male
Reported by a physician from Japan on 2012-07-06
Patient: male, weighing 63.6 kg (139.9 pounds)
Reactions: Abdominal Discomfort, Colon Cancer, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Dosage: 300 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-05-09
Pradaxa
Administration route: Oral
Start date: 2012-06-05
Other drugs received by patient: Famotidine; Adalat CC; Lansoprazole
Possible Pradaxa side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-05
Patient: female
Reactions: Cardiac Failure, Melaena
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Pradaxa
Dosage: 220 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2011-05-01
End date: 2012-05-01
Pradaxa
Dosage: 150 mg
Administration route: Oral
Start date: 2012-05-01
Possible Pradaxa side effects in 74 year old female
Reported by a physician from United States on 2012-07-05
Patient: 74 year old female
Reactions: Gastrointestinal Haemorrhage, Haemorrhage, Diarrhoea Haemorrhagic, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Dosage: 150 mg
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Pradaxa
Indication: Atrial Fibrillation
Other drugs received by patient: Aspirin; Mobic
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