|
Index of reports
> Cases with Rectal Haemorrhage (351)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Pradaxa (Dabigatran) where reactions include rectal haemorrhage. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 351 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 female
Reported by a physician from United States on 2012-08-22
Patient: female
Reactions: Rectal Haemorrhage, Constipation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in 84 year old female
Reported by a physician from France on 2012-08-22
Patient: 84 year old female
Reactions: Haemoglobin Decreased, RED Blood Cell Count Decreased, Rectal Haemorrhage, International Normalised Ratio Abnormal
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Coumadin
Dosage: 1 df = two scored tablets daily
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-04-16
End date: 2012-04-30
Pradaxa
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-05-01
End date: 2012-05-02
Other drugs received by patient: Digoxin; Hyperium; Micardis; Amlodipine Besylate; Pravastatin; Lexomil; Polyethylene Glycol; Lansoprazole
Possible Pradaxa side effects in female
Reported by a physician from United Kingdom on 2012-08-22
Patient: female, weighing 49.9 kg (109.8 pounds)
Reactions: Rectal Haemorrhage, Embolic Stroke, Atrial Fibrillation, Hemiparesis, Coma Scale Abnormal, Treatment Noncompliance, Product Size Issue
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Dosage: 220 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-01-13
End date: 2012-04-25
Pradaxa
Indication: Transient Ischaemic Attack
Other drugs received by patient: Simvastatin; Bisoprolol Fumarate; Digoxin; Acetaminophen; Mebeverine; Omeprazole; Anastrozole
Possible Pradaxa side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: male
Reactions: Rectal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in 74 year old male
Reported by a pharmacist from United States on 2012-08-20
Patient: 74 year old male, weighing 85.0 kg (187.0 pounds)
Reactions: Haematochezia, Gastrointestinal Haemorrhage, Renal Failure, Rectal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Calcitriol; Bumetanide; Omeprazole; Metolazone; Procrit; Spironolactone; Allopurinol; Ferrous Sulfate TAB; M.v.i.
Possible Pradaxa side effects in female
Reported by a physician from United Kingdom on 2012-08-20
Patient: female, weighing 65.0 kg (143.0 pounds)
Reactions: HIP Fracture, Abdominal Pain, Death, Rectal Haemorrhage, Cerebrovascular Accident
Adverse event resulted in: death, hospitalization, disablity
Drug(s) suspected as cause:
Pradaxa
Dosage: 220 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2010-02-01
End date: 2012-04-12
Pradaxa
Indication: Thrombocytopenia
Other drugs received by patient: Vitamin Capsules BPC; E45 Cream; Memantine Hydrochloride; Memantine Hydrochloride; Senna; Acetaminophen; Simvastatin; Bisoprolol Fumarate; Furosemide; Hydromol Ointment; Lansoprazole; Lactulose; Maxitrol EYE Drops
Possible Pradaxa side effects in 78 year old female
Reported by a physician from Romania on 2012-08-17
Patient: 78 year old female, weighing 75.0 kg (165.0 pounds)
Reactions: Rectal Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Digoxin; Metoprolol Tartrate; Atorvastatin Calcium; Piracetam; Biseptrim
Possible Pradaxa side effects in female
Reported by a physician from United States on 2012-08-16
Patient: female
Reactions: Rectal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in 78 year old female
Reported by a physician from Romania on 2012-08-14
Patient: 78 year old female, weighing 75.0 kg (165.0 pounds)
Reactions: Rectal Haemorrhage
Adverse event resulted in: death
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Digoxin; Piracetam; Biseptrim; Metoprolol Tartrate; Atorvastatin Calcium
Possible Pradaxa side effects in 77 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14
Patient: 77 year old female
Reactions: Rectal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Letairis
Possible Pradaxa side effects in female
Reported by a physician from United Kingdom on 2012-08-10
Patient: female, weighing 65.0 kg (143.0 pounds)
Reactions: HIP Fracture, Abdominal Pain, Death, Rectal Haemorrhage, Cerebrovascular Accident
Adverse event resulted in: death, hospitalization, disablity
Drug(s) suspected as cause:
Pradaxa
Indication: Thrombocytopenia
Pradaxa
Dosage: 220 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2010-02-01
End date: 2012-04-12
Other drugs received by patient: Maxitrol EYE Drops; Vitamin Capsules BPC; E45 Cream; Senna-Mint WAF; Hydromol Ointment; Furosemide; Lansoprazole; Bisoprolol Fumarate; Acetaminophen; Lactulose; Memantine Hydrochloride; Simvastatin; Memantine Hydrochloride
Possible Pradaxa side effects in 80 year old female
Reported by a physician from Israel on 2012-08-10
Patient: 80 year old female
Reactions: Haemoglobin Decreased, Rectal Haemorrhage, Convulsion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Pradaxa
Indication: Deep Vein Thrombosis
Pradaxa
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-05-08
Pradaxa
Indication: Cerebrovascular Accident
Other drugs received by patient: Ramipril; Bisoprolol Fumarate; Apidra; Lyrica; Ramipril; Furosemide; Mixtard Insulin 30 / 70; Simvastatin; Recital; Neobloc; Lantus
Possible Pradaxa side effects in male
Reported by a physician from Australia on 2012-08-10
Patient: male, weighing 69.0 kg (151.8 pounds)
Reactions: Colon Cancer, Prostate Cancer, Rectal Haemorrhage
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Pradaxa
Indication: Atrial Fibrillation
Pradaxa
Dosage: 220 mg
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2011-10-13
Other drugs received by patient: Irbesartan and Hydrochlorothiazide
Possible Pradaxa side effects in male
Reported by a physician from Denmark on 2012-08-09
Patient: male
Reactions: Haematochezia, Frequent Bowel Movements, Anaemia, Hypotension, Rectal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Centyl MED Kaliumklorid
Possible Pradaxa side effects in 62 year old male
Reported by a physician from United States on 2012-08-06
Patient: 62 year old male
Reactions: Rectal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Sotalol Hydrochloride; Lipitor
Possible Pradaxa side effects in 77 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06
Patient: 77 year old female
Reactions: Rectal Haemorrhage, Atrial Fibrillation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Letairis
Dosage: 5 mg, unk
Administration route: Oral
Indication: Pulmonary Hypertension
Start date: 2011-11-10
Pradaxa
Dosage: unk
Start date: 2012-06-01
Possible Pradaxa side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: female
Reactions: Rectal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in 68 year old female
Reported by a consumer/non-health professional from United States on 2012-07-31
Patient: 68 year old female
Reactions: Gingival Bleeding, Rectal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-07-30
Patient: female, weighing 64.0 kg (140.8 pounds)
Reactions: Rectal Haemorrhage, Cognitive Disorder, Pallor
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Centyl with Kaliumklorid; Pulmicort; Simvastatin; Bisoprolol Fumarate; Digoxin
Possible Pradaxa side effects in male
Reported by a physician from Australia on 2012-07-30
Patient: male
Reactions: Colon Cancer, Prostate Cancer, Rectal Haemorrhage
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Pradaxa
Dosage: 220 mg
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2011-10-13
Pradaxa
Indication: Atrial Fibrillation
Possible Pradaxa side effects in 89 year old female
Reported by a physician from Germany on 2012-07-23
Patient: 89 year old female, weighing 66.0 kg (145.2 pounds)
Reactions: Haemoglobin Decreased, Rectal Haemorrhage, Constipation, Faeces Hard
Drug(s) suspected as cause:
Pradaxa
Dosage: 150 mg
Indication: Atrial Fibrillation
Start date: 2012-02-20
Pradaxa
Dosage: 220 mg
Other drugs received by patient: Seroquel; Pantoprazole; Thorasemid; Metoprolol Succinate; Seroquel; Seroquel; Citalopram Hydrobromide; Captopril; Metamizol
Possible Pradaxa side effects in male
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-20
Patient: male, weighing 68.0 kg (149.6 pounds)
Reactions: Gastrointestinal Haemorrhage, Overdose, Mouth Haemorrhage, Rectal Haemorrhage, Prothrombin Time Shortened, Haemorrhagic Anaemia, Septic Shock
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in 80 year old female
Reported by a physician from Israel on 2012-07-20
Patient: 80 year old female
Reactions: Haemoglobin Decreased, Rectal Haemorrhage, Convulsion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Pradaxa
Administration route: Oral
Indication: Atrial Fibrillation
Pradaxa
Indication: Cerebrovascular Accident
Pradaxa
Indication: Deep Vein Thrombosis
Other drugs received by patient: Ramipril; Mixtard Insulin 30 / 70; Concor; Furosemide
Possible Pradaxa side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-20
Patient: male
Reactions: Renal Disorder, Blood Urine Present, Contusion, Rectal Haemorrhage, Rash Macular, Conjunctival Haemorrhage, Bleeding Time Prolonged, Large Intestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Dosage: 300 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-01-01
End date: 2012-03-01
Pradaxa
Dosage: 300 mg
Administration route: Oral
Start date: 2012-03-01
End date: 2012-07-08
Other drugs received by patient: Amiodarone HCL; Ramipril; Aspirin; Medication NOT Further Specified
Possible Pradaxa side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-20
Patient: male
Reactions: Rectal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in male
Reported by a physician from Germany on 2012-07-20
Patient: male
Reactions: Haemorrhage, Rectal Haemorrhage, Haematuria
Adverse event resulted in: death
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Pantoprazole; Metoprolol Succinate; Ramipril; Torsemide
Possible Pradaxa side effects in 77 year old female
Reported by a individual with unspecified qualification from United States on 2012-07-19
Patient: 77 year old female, weighing 78.9 kg (173.6 pounds)
Reactions: Rectal Haemorrhage, Lower Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in 86 year old female
Reported by a individual with unspecified qualification from United States on 2012-07-19
Patient: 86 year old female, weighing 61.2 kg (134.6 pounds)
Reactions: Rectal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Possible Pradaxa side effects in female
Reported by a pharmacist from United States on 2012-07-18
Patient: female, weighing 146.1 kg (321.3 pounds)
Reactions: Rectal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Pradaxa
Other drugs received by patient: Sod. CHL 0.9%; Miconazole Nitrate Powder; Ondansetron; Spironolactone; Cefazolin; Hydromorphone Hydrochloride; Levothyroxine Home MED; Oxybutynin; Lisinopril; Neomyxin / Bacit / Poly; Chlorhexidine Gluconate; Magnesium Hydrox; Pantoprazole; Amlodipine; Atenolol; Calcium; Tramadol Hydrochloride; DEX 5%
Page 1 Next >>
|
