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Pradaxa (Dabigatran) - Rectal Haemorrhage - Suspected Cause - Side Effect Reports

 
 



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 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 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 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 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 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 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 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 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 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 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 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 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 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 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%



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