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Pradaxa (Dabigatran) - Melaena - Suspected Cause - Side Effect Reports

 
 



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 90 year old male

Reported by a physician from Japan on 2012-07-05

Patient: 90 year old male

Reactions: Pneumonia, Wrong Technique in Drug Usage Process, Decubitus Ulcer, Melaena

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pradaxa

Other drugs received by patient: Unknown Drug



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



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