This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Xarelto (Rivaroxaban) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (3139)
Death (303)
Life Threatening Events (213)
Disability (76)
Reports by Reaction Type
Pulmonary Embolism (440),
Deep Vein Thrombosis (310),
Gastrointestinal Haemorrhage (194),
Haemorrhage (155),
Thrombosis (121),
Cerebrovascular Accident (112),
Haemoglobin Decreased (111),
Oedema Peripheral (105),
Haematoma (103),
Haemorrhage Intracranial (94),
Dyspnoea (85),
Death (73)
Below are a few examples of reports where side effects / adverse reactions may be related to Xarelto (Rivaroxaban). For a complete list or a specific selection of reports, please use the links above.
Possible Xarelto side effects in 91 year old female
Reported by a physician from United States on 2012-08-27
Patient: 91 year old female
Reactions: Fall, Haematoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Possible Xarelto side effects in female
Reported by a pharmacist from United States on 2012-08-27
Patient: female, weighing 72.0 kg (158.4 pounds)
Reactions: Thrombosis, Dysphagia, Unresponsive To Stimuli, Cerebrovascular Accident, Subdural Haemorrhage, Fall, Loss of Consciousness, Death, Grand MAL Convulsion, Communication Disorder, Lower Gastrointestinal Haemorrhage, Haematoma
Adverse event resulted in: death, hospitalization, disablity
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-01-17
End date: 2012-01-18
Xarelto
Dosage: daily at 5 pm
Administration route: Oral
Start date: 2012-01-01
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-01-17
End date: 2012-01-18
Xarelto
Dosage: daily at 5 pm
Administration route: Oral
Start date: 2012-01-01
Other drugs received by patient: Tylenol; Tekturna; Celexa; Lortab; Ascorbic Acid; Magnesium Hydroxide TAB; Lanoxin; Hydrocodone; Milk OF Magnesia TAB; Hydralazine HCL; Icaps; Xanax; Lescol XL; Regular Insulin; Aricept; Magnesium Oxide; Ciprofloxacin HCL; Levemir; Imodium; Vitamin; Percogesic; Pepcid; Fish OIL
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
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient:
Reactions: Adverse Event
Drug(s) suspected as cause:
Xarelto
Possible Xarelto side effects in 92 year old female
Reported by a pharmacist from United States on 2012-08-27
Patient: 92 year old female, weighing 70.3 kg (154.7 pounds)
Reactions: Fall, Cerebral Haemorrhage
Drug(s) suspected as cause:
Xarelto
Other drugs received by patient: Lasix; Zaroxolyn; Lipitor; Atenolol; Lexapro
Possible Xarelto side effects in
Reported by a pharmacist from United States on 2012-08-27
Patient:
Reactions: Pulmonary Embolism
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Thrombosis Prophylaxis
Start date: 2012-01-01
Xarelto
Administration route: Oral
Indication: Knee Arthroplasty
Start date: 2012-01-01
Possible Xarelto side effects in 89 year old male
Reported by a physician from United States on 2012-08-27
Patient: 89 year old male
Reactions: Death, Haemoptysis
Adverse event resulted in: death
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Orthopedic Procedure
Xarelto
Administration route: Oral
Indication: Thrombosis Prophylaxis
Possible Xarelto side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female
Reactions: Haemorrhagic Stroke
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Possible Xarelto side effects in
Reported by a physician from United States on 2012-08-27
Patient:
Reactions: Gastrointestinal Haemorrhage, Arteriovenous Malformation
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Xarelto
Administration route: Oral
Indication: Thrombosis Prophylaxis
Possible Xarelto side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male
Reactions: Pulmonary Embolism
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Knee Arthroplasty
Xarelto
Administration route: Oral
Indication: Thrombosis Prophylaxis
Possible Xarelto side effects in male
Reported by a pharmacist from United States on 2012-08-27
Patient: male
Reactions: Pulmonary Embolism
Drug(s) suspected as cause:
Xarelto
Possible Xarelto side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female
Reactions: International Normalised Ratio Increased, Platelet Count Increased
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: HIP Surgery
Xarelto
Administration route: Oral
Indication: Thrombosis Prophylaxis
Possible Xarelto side effects in male
Reported by a pharmacist from United States on 2012-08-27
Patient: male
Reactions: Hypertension, Cerebral Haemorrhage
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
End date: 2012-08-13
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
End date: 2012-08-13
Possible Xarelto side effects in 71 year old male
Reported by a physician from United States on 2012-08-27
Patient: 71 year old male
Reactions: Intestinal Perforation, Gastrointestinal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Possible Xarelto side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male
Reactions: Cerebrovascular Accident
Adverse event resulted in: 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: Dilantin
Possible Xarelto side effects in female
Reported by a physician from Germany on 2012-08-27
Patient: female, weighing 75.0 kg (165.0 pounds)
Reactions: Renal Failure, Hepatic Enzyme Increased
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Start date: 2012-05-15
End date: 2012-06-19
Xarelto
Administration route: Oral
Start date: 2012-05-15
End date: 2012-06-19
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-06-20
End date: 2012-07-18
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-06-20
End date: 2012-07-18
Other drugs received by patient: Moxonidin; Lisinopril; Allopurinol; Simvastatin; Levothyroxine Sodium; Bisoprolol Fumarate
Possible Xarelto side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient:
Reactions: Oedema Peripheral, Wound Complication
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Orthopedic Procedure
Xarelto
Administration route: Oral
Indication: Thrombosis Prophylaxis
Possible Xarelto side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female, weighing 68.0 kg (149.7 pounds)
Reactions: Dehydration, Flank Pain, Retroperitoneal Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-07-25
End date: 2012-08-09
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-07-25
End date: 2012-08-09
Other drugs received by patient: Fluticasone Propionate; Propafenone HCL; Nasonex; Minocycline HCL; Singulair
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 76 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-27
Patient: 76 year old male
Reactions: Pericardial Effusion
Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
Administration route: Oral
Indication: Product Used FOR Unknown Indication
End date: 2012-03-12
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-03-12
End date: 2012-03-15
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-03-12
End date: 2012-03-15
Other drugs received by patient: Levofloxacin; Valsartan; Metoprolol Succinate
Possible Xarelto side effects in female
Reported by a physician from United States on 2012-08-27
Patient: female, weighing 58.5 kg (128.7 pounds)
Reactions: Migraine, Head Injury, Tremor, Balance Disorder, Dehydration, Renal Pain, Hallucination, Skeletal Injury, Decreased Appetite
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-05-22
End date: 2012-05-31
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-05-22
End date: 2012-05-31
Other drugs received by patient: Metoprolol Tartrate; Digoxin; Lorazepam; Diltiazem; Klor-CON; Lasix
Possible Xarelto side effects in 62 year old male
Reported by a physician from United States on 2012-08-27
Patient: 62 year old male
Reactions: Pericardial Effusion
Drug(s) suspected as cause:
Xarelto
Possible Xarelto side effects in 76 year old male
Reported by a consumer/non-health professional from Germany on 2012-08-25
Patient: 76 year old male
Reactions: Pericardial Effusion
Drug(s) suspected as cause:
Aspirin
Dosage: 100 mg, qd
Administration route: Oral
End date: 2012-03-12
Xarelto
Indication: Cerebrovascular Accident Prophylaxis
Xarelto
Dosage: 20 mg, qd
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-03-12
End date: 2012-03-15
Other drugs received by patient: Metoprolol Succinate; Levofloxacin; Valsartan
Possible Xarelto side effects in 70 year old male
Reported by a physician from Germany on 2012-08-24
Patient: 70 year old male
Reactions: Diarrhoea, Pulmonary Embolism, Blood Creatinine Increased
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Thrombosis Prophylaxis
Xarelto
Administration route: Oral
Indication: Embolism Venous
Possible Xarelto side effects in
Reported by a physician from United States on 2012-08-24
Patient:
Reactions: Cerebrovascular Accident
Drug(s) suspected as cause:
Xarelto
Possible Xarelto side effects in
Reported by a physician from United States on 2012-08-24
Patient:
Reactions: Thrombosis
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-03-01
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-03-01
Possible Xarelto side effects in male
Reported by a physician from United States on 2012-08-24
Patient: male
Reactions: Transient Ischaemic Attack
Drug(s) suspected as cause:
Tylenol
Indication: Product Used FOR Unknown Indication
Tylenol
Xarelto
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Mylanta (Aluminium Hydroxide / Magnesium Hydroxide); Aspirin; Multiple Medications
Possible Xarelto side effects in 82 year old male
Reported by a physician from United States on 2012-08-24
Patient: 82 year old male
Reactions: Drug Dose Omission, Rash Generalised, Cerebrovascular Accident
Drug(s) suspected as cause:
Xarelto
Other drugs received by patient: Vitamin / Minerals; Lutein; Lipitor; Sotalol HCL; Prostatin; Lovaza; Betapace; Vitamin B-12; Proscar
Possible Xarelto side effects in 62 year old male
Reported by a physician from United States on 2012-08-24
Patient: 62 year old male
Reactions: Pericardial Effusion
Drug(s) suspected as cause:
Xarelto
Possible Xarelto side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient:
Reactions: Cerebrovascular Accident
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
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