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Index of reports
> Life Threatening Events (213)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Xarelto (Rivaroxaban) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 213 Next >>
Possible Xarelto side effects in 74 year old female
Reported by a pharmacist from United States on 2012-08-27
Patient: 74 year old female, weighing 56.0 kg (123.2 pounds)
Reactions: Haematochezia, Polypectomy, Dyspnoea, Gastrointestinal Haemorrhage, Diverticulum, Anaemia, Haemorrhagic Arteriovenous Malformation
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Other drugs received by patient: Multaq; Cardizem CD; Lasix; Combivent; Potassium Chloride
Possible Xarelto side effects in male
Reported by a pharmacist from United States on 2012-08-27
Patient: male, weighing 86.2 kg (189.6 pounds)
Reactions: Pulmonary Embolism, Oxygen Saturation Decreased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Embolism Venous
Start date: 2012-06-05
End date: 2012-06-07
Xarelto
Administration route: Oral
Indication: Knee Arthroplasty
Start date: 2012-06-05
End date: 2012-06-07
Other drugs received by patient: Cyanocobalamin; Oxycodone HCL; Docusate Sodium; Oxycontin; Ferrous Sulfate TAB
Possible Xarelto side effects in male
Reported by a health professional (non-physician/pharmacist) from Norway on 2012-08-24
Patient: male
Reactions: Gastric Ulcer Haemorrhage, Skin Necrosis, Traumatic Haematoma, Cardiovascular Disorder
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-07-17
End date: 2012-07-23
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-07-17
End date: 2012-07-23
Other drugs received by patient: Acetaminophen; Nycoplus B-Combin Staerk; Metoprolol Succinate; Renitec M
Possible Xarelto side effects in female
Reported by a physician from Germany on 2012-08-24
Patient: female, weighing 120.0 kg (264.0 pounds)
Reactions: Speech Disorder, Haemoglobin Decreased, Haemorrhagic Anaemia, Menorrhagia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Deep Vein Thrombosis
Start date: 2012-07-27
End date: 2012-08-14
Xarelto
Administration route: Oral
Indication: Embolism Venous
Start date: 2012-07-27
End date: 2012-08-14
Possible Xarelto side effects in 74 year old female
Reported by a pharmacist from United States on 2012-08-23
Patient: 74 year old female, weighing 56.0 kg (123.2 pounds)
Reactions: Polypectomy, Haematochezia, Gastrointestinal Haemorrhage, Dyspnoea, Diverticulum, Anaemia, Haemorrhagic Arteriovenous Malformation
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Other drugs received by patient: Cardizem CD; Lasix; Multaq; Combivent; Potassium Chloride
Possible Xarelto side effects in female
Reported by a physician from Austria on 2012-08-23
Patient: female
Reactions: Aphagia, Paraparesis, Aphasia, Coma, Cerebral Haemorrhage
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Xarelto
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-07-22
Xarelto
Indication: Atrial Fibrillation
Start date: 2012-07-22
Possible Xarelto side effects in 77 year old male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 77 year old male, weighing 107.0 kg (235.5 pounds)
Reactions: Asthenia, Fall
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Xarelto
Possible Xarelto side effects in
Reported by a physician from United States on 2012-08-23
Patient:
Reactions: Ischaemic Stroke
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-04-01
End date: 2012-06-01
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-04-01
End date: 2012-06-01
Other drugs received by patient: Coreg; Lisinopril
Possible Xarelto side effects in female
Reported by a physician from Germany on 2012-08-22
Patient: female, weighing 65.0 kg (143.0 pounds)
Reactions: Vomiting, Nausea, Pulmonary Embolism
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Other drugs received by patient: Ethinyl Estradiol; Tramadol Hydrochloride; Novalgin
Possible Xarelto side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: male, weighing 116.6 kg (256.5 pounds)
Reactions: Cardiac Tamponade, Renal Failure, Pulmonary Oedema, Pericardial Effusion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Dosage: started between the 19th and the 26th of june
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-06-01
Xarelto
Dosage: started between the 19th and the 26th of june
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-06-01
Other drugs received by patient: Lipitor; Spironolactone; Fentanyl Citrate; Protonix; Pain Medication; Meloxicam; Lyrica; Furosemide; Losartan Potassium; Hydrocodone Bitartrate and Acetaminophen
Possible Xarelto side effects in male
Reported by a physician from United States on 2012-08-20
Patient: male, weighing 113.4 kg (249.5 pounds)
Reactions: Pulmonary Embolism
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Dosage: start date reported as ^pod#1^
Administration route: Oral
Indication: Knee Arthroplasty
Start date: 2012-07-24
Xarelto
Dosage: start date reported as ^pod#1^
Administration route: Oral
Indication: Thrombosis Prophylaxis
Start date: 2012-07-24
Other drugs received by patient: Multi-Vitamins; Hydrocodone Bitartrate
Possible Xarelto side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-20
Patient: female, weighing 103.0 kg (226.5 pounds)
Reactions: Myalgia, Contusion, Rash Erythematous, Oedema Peripheral, Urticaria, Open Wound
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Thrombosis Prophylaxis
Start date: 2012-05-10
End date: 2012-05-22
Xarelto
Administration route: Oral
Indication: Knee Arthroplasty
Start date: 2012-05-10
End date: 2012-05-22
Possible Xarelto side effects in 74 year old female
Reported by a pharmacist from United States on 2012-08-20
Patient: 74 year old female, weighing 56.0 kg (123.2 pounds)
Reactions: Polypectomy, Haematochezia, Gastrointestinal Haemorrhage, Dyspnoea, Diverticulum, Haemorrhagic Arteriovenous Malformation, Anaemia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Other drugs received by patient: Multaq; Potassium Chloride; Combivent; Lasix; Cardizem CD
Possible Xarelto side effects in 83 year old male
Reported by a pharmacist from United States on 2012-08-16
Patient: 83 year old male, weighing 95.3 kg (209.6 pounds)
Reactions: Gastrointestinal Haemorrhage
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Possible Xarelto side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-14
Patient: female, weighing 88.8 kg (195.4 pounds)
Reactions: Pulmonary Embolism, Embolism Venous, Treatment Noncompliance
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Thrombosis Prophylaxis
Start date: 2012-06-01
Xarelto
Administration route: Oral
Indication: Knee Arthroplasty
Start date: 2012-06-01
Possible Xarelto side effects in male
Reported by a physician from Germany on 2012-08-13
Patient: male, weighing 73.0 kg (160.6 pounds)
Reactions: Hypertension, Epistaxis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Possible Xarelto side effects in 53 year old male
Reported by a physician from United States on 2012-08-13
Patient: 53 year old male, weighing 98.1 kg (215.8 pounds)
Reactions: Abdominal Pain, Diarrhoea, Oedema Peripheral, Prothrombin Time Prolonged, Cerebrovascular Accident
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Multaq
Start date: 2012-05-15
End date: 2012-05-15
Xarelto
Indication: Anticoagulant Therapy
Start date: 2012-05-03
Xarelto
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-05-03
Xarelto
Indication: Atrial Fibrillation
Start date: 2012-05-03
Other drugs received by patient: Flecainide Acetate; Furosemide; Nebivolol
Possible Xarelto side effects in 74 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-10
Patient: 74 year old female, weighing 63.0 kg (138.6 pounds)
Reactions: Pulmonary Embolism
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Other drugs received by patient: Fybogel; Aspirin; Adalat CC; Alendronate Sodium; Simvastatin; Lisinopril; Bendroflumethiazide; Calcichew D3
Possible Xarelto side effects in male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-09
Patient: male
Reactions: Brain Midline Shift, Cerebral Haemorrhage
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Other drugs received by patient: Terazosin Hydrochloride; Lyrica; Hydromorphone Hydrochloride
Possible Xarelto side effects in female
Reported by a physician from Turkey on 2012-08-08
Patient: female
Reactions: Cerebral Artery Embolism
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Xarelto
Other drugs received by patient: Avelox; Tenoxicam; Sefazol
Possible Xarelto side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-07
Patient: female, weighing 67.6 kg (148.7 pounds)
Reactions: Cerebrovascular Accident, Treatment Noncompliance
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-03-05
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-03-05
Other drugs received by patient: Digoxin; Lipitor; Coreg; Ramipril; Diltiazem
Possible Xarelto side effects in 80 year old female
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-07
Patient: 80 year old female
Reactions: Haemorrhage, Shock Haemorrhagic
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Aspirin
Indication: Product Used FOR Unknown Indication
Xarelto
Indication: Product Used FOR Unknown Indication
Possible Xarelto side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07
Patient: male, weighing 116.6 kg (256.5 pounds)
Reactions: Renal Failure, Cardiac Tamponade, Pulmonary Oedema, Pericardial Effusion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Dosage: started between the 19th and the 26th of june
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-06-01
Xarelto
Dosage: started between the 19th and the 26th of june
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-06-01
Other drugs received by patient: Fentanyl; Lipitor; Lyrica; Hydrocodone Bitartrate and Acetaminophen; Furosemide; Losartan Potassium; Protonix; Spironolactone; Pain Medication; Meloxicam
Possible Xarelto side effects in 71 year old male
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient: 71 year old male
Reactions: Renal Failure, Cardiac Tamponade, Pulmonary Oedema
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Other drugs received by patient: Pain Medication
Possible Xarelto side effects in 85 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03
Patient: 85 year old male, weighing 112.5 kg (247.5 pounds)
Reactions: Cardiac Tamponade, Pericardial Effusion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Start date: 2012-06-21
Xarelto
Administration route: Oral
Start date: 2012-06-21
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-05-31
End date: 2012-06-11
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-05-31
End date: 2012-06-11
Other drugs received by patient: Coumadin; Aspirin; Cardiac Medication
Possible Xarelto side effects in male
Reported by a physician from Germany on 2012-08-03
Patient: male, weighing 88.0 kg (193.6 pounds)
Reactions: Embolism, Post Procedural Haemorrhage
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
End date: 2012-06-28
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
End date: 2012-06-28
Other drugs received by patient: Lercanidipine; Digoxin; Ramipril; Simvastatin
Possible Xarelto side effects in 85 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02
Patient: 85 year old male
Reactions: Cardiac Tamponade, Pericardial Effusion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
End date: 2012-06-01
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
End date: 2012-06-01
Possible Xarelto side effects in 71 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01
Patient: 71 year old male
Reactions: Renal Failure, Cardiac Tamponade, Pulmonary Oedema
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Other drugs received by patient: Pain Medication
Possible Xarelto side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01
Patient: male, weighing 113.4 kg (249.5 pounds)
Reactions: Nausea, Pulmonary Embolism, Acute Respiratory Failure
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Thrombosis Prophylaxis
Start date: 2012-01-16
Xarelto
Administration route: Oral
Indication: Knee Arthroplasty
Start date: 2012-01-16
Possible Xarelto side effects in 64 year old female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-31
Patient: 64 year old female, weighing 65.8 kg (144.7 pounds)
Reactions: Rectal Haemorrhage, Hypotension, Renal Failure Acute
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Thrombosis Prophylaxis
Start date: 2011-12-03
End date: 2011-12-05
Xarelto
Administration route: Oral
Indication: Anticoagulant Therapy
Start date: 2011-12-03
End date: 2011-12-05
Other drugs received by patient: Conjugated Estrogens; Prednisone; Hydrocortisone; Creon; Acetaminophen; Atorvastatin
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