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Xarelto (Rivaroxaban) - Side Effect Reports to FDA

 
 



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 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 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 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 81 year old female

Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-08-24

Patient: 81 year old female

Reactions: Depressed Level of Consciousness, Cognitive Disorder, Epilepsy, Cerebral Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Metoprolol Succinate
    Indication: Atrial Flutter

Metoprolol Succinate
    Dosage: 25 mg, unk
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-06-17
    End date: 2012-06-21

Xarelto
    Indication: Atrial Flutter

Xarelto
    Dosage: 20 mg, unk
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-06-20
    End date: 2012-06-21

Other drugs received by patient: Pantoprazole; Novalgin



Possible Xarelto side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female

Reactions: Gastrointestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xarelto
    Administration route: Oral
    Indication: Cerebrovascular Accident Prophylaxis
    Start date: 2012-01-01
    End date: 2012-01-01

Xarelto
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-01-01
    End date: 2012-01-01



Possible Xarelto side effects in male

Reported by a physician from United States on 2012-08-24

Patient: male

Reactions: Catheterisation Cardiac

Drug(s) suspected as cause:
Xarelto



Possible Xarelto side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Haemorrhage Intracranial

Drug(s) suspected as cause:
Xarelto



Possible Xarelto side effects in female

Reported by a consumer/non-health professional from Germany on 2012-08-24

Patient: female

Reactions: Mobility Decreased

Drug(s) suspected as cause:
Xarelto
    Indication: Atrial Fibrillation
    Start date: 2012-03-01

Xarelto
    Indication: Cerebrovascular Accident Prophylaxis
    Start date: 2012-03-01

Other drugs received by patient: Marcumar



Possible Xarelto side effects in 56 year old male

Reported by a pharmacist from Japan on 2012-08-24

Patient: 56 year old male

Reactions: Cerebral Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Xarelto
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-06-08
    End date: 2012-06-11

Xarelto
    Administration route: Oral
    Indication: Cerebrovascular Accident Prophylaxis
    Start date: 2012-06-08
    End date: 2012-06-11



Possible Xarelto side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient:

Reactions: Pulmonary Embolism

Drug(s) suspected as cause:
Xarelto

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