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Rivaroxaban Side Effects

PatientsVille

Common Rivaroxaban Side Effects


The most commonly reported Rivaroxaban side effects (click to view or check a box to report):

Gastrointestinal Haemorrhage (50)
Haemoglobin Decreased (30)
Pulmonary Embolism (28)
Anaemia (24)
Hypotension (20)
Haematuria (19)
Asthenia (17)
Melaena (16)
Haemorrhage Intracranial (15)
International Normalised Ratio Increased (15)
Dyspnoea (15)
Deep Vein Thrombosis (15)
Epistaxis (14)
Haematochezia (12)
Haemorrhage (12)
Rectal Haemorrhage (12)
Post Procedural Haemorrhage (12)
Diarrhoea (11)
Dizziness (10)
Contusion (10)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Rivaroxaban Side Effects Reported to FDA



Rivaroxaban Side Effect Report#9994870
Hepatitis Acute, Transaminases Increased
This is a report of a 78-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: embolism venous,deep vein thrombosis, who was treated with Rivaroxaban (dosage: NA, start time:
Jan 31, 2014), combined with: NA. and developed a serious reaction and side effect(s): Hepatitis Acute, Transaminases Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rivaroxaban treatment in female patients, resulting in Hepatitis Acute side effect. The patient was hospitalized.
Rivaroxaban Side Effect Report#9982522
Rectal Haemorrhage
This report suggests a potential Rivaroxaban Rectal Haemorrhage side effect(s) that can have serious consequences. A 77-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pulmonary embolism and used Rivaroxaban (dosage: NA) starting
Jan 09, 2014. After starting Rivaroxaban the patient began experiencing various side effects, including: Rectal HaemorrhageAdditional drugs used concurrently: NA.The patient was hospitalized. Although Rivaroxaban demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rectal Haemorrhage, may still occur.
Rivaroxaban Side Effect Report#9959655
Haemorrhage Intracranial, Endocarditis, Septic Embolus
This Haemorrhage Intracranial problem was reported by a pharmacist from US. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Feb 16, 2014 this consumer started treatment with Rivaroxaban (dosage: NA). The following drugs were being taken at the same time: NA. When using Rivaroxaban, the patient experienced the following unwanted symptoms/side effects: Haemorrhage Intracranial, Endocarditis, Septic EmbolusThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Haemorrhage Intracranial, may become evident only after a product is in use by the general population.
Rivaroxaban Side Effect Report#9949241
Atrial Fibrillation, Atrial Fibrillation
This Atrial Fibrillation side effect was reported by a health professional from NL. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: cerebrovascular accident prophylaxis,atrial fibrillation.The patient was prescribed Rivaroxaban (drug dosage: NA), which was initiated on
Nov 17, 2013. Concurrently used drugs: NA..After starting to take Rivaroxaban the consumer reported adverse symptoms, such as: Atrial Fibrillation, Atrial FibrillationThese side effects may potentially be related to Rivaroxaban. The patient was hospitalized.
Rivaroxaban Side Effect Report#9938683
Blue Toe Syndrome
This is a report of a 87-year-old male patient (weight: NA) from ES, suffering from the following health symptoms/conditions: thrombosis prophylaxis,deep vein thrombosis, who was treated with Rivaroxaban (dosage: NA, start time:
Dec 21, 2013), combined with: NA. and developed a serious reaction and side effect(s): Blue Toe Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rivaroxaban treatment in male patients, resulting in Blue Toe Syndrome side effect. The patient was hospitalized.
Rivaroxaban Side Effect Report#9931679
Pulmonary Embolism
This report suggests a potential Rivaroxaban Pulmonary Embolism side effect(s) that can have serious consequences. A 38-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Rivaroxaban (dosage: NA) starting NS. After starting Rivaroxaban the patient began experiencing various side effects, including: Pulmonary EmbolismAdditional drugs used concurrently: NA. Although Rivaroxaban demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pulmonary Embolism, may still occur.
Rivaroxaban Side Effect Report#9928390
Rectal Haemorrhage, Gastrointestinal Haemorrhage, Haemorrhagic Anaemia
This Rectal Haemorrhage problem was reported by a pharmacist from US. A 79-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation,deep vein thrombosis. On
Oct 20, 2013 this consumer started treatment with Rivaroxaban 20 Mg Janssen (dosage: 20 Mg Once Daily By Mouth). The following drugs were being taken at the same time: NA. When using Rivaroxaban 20 Mg Janssen, the patient experienced the following unwanted symptoms/side effects: Rectal Haemorrhage, Gastrointestinal Haemorrhage, Haemorrhagic AnaemiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rectal Haemorrhage, may become evident only after a product is in use by the general population.
Rivaroxaban Side Effect Report#9928191
Venous Thrombosis, Venous Occlusion
This Venous Thrombosis side effect was reported by a health professional from PL. A 42-year-old male patient (weight:NA) experienced the following symptoms/conditions: deep vein thrombosis.The patient was prescribed Rivaroxaban (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Rivaroxaban the consumer reported adverse symptoms, such as: Venous Thrombosis, Venous OcclusionThese side effects may potentially be related to Rivaroxaban.
Rivaroxaban Side Effect Report#9928188
Thrombosis
This is a report of a 62-year-old male patient (weight: NA) from AT, suffering from the following health symptoms/conditions: atrial fibrillation, who was treated with Rivaroxaban (dosage: NA, start time: NS), combined with:
  • Rosuvastatin
  • Hydrochlorothiazide
  • Spironolactone
  • Bisoprolol
  • Lisinopril
and developed a serious reaction and side effect(s): Thrombosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rivaroxaban treatment in male patients, resulting in Thrombosis side effect.
Rivaroxaban Side Effect Report#9924951
Venous Occlusion, Venous Thrombosis
This report suggests a potential Rivaroxaban Venous Occlusion side effect(s) that can have serious consequences. A 17-year-old female patient (weight: NA) from PL was diagnosed with the following symptoms/conditions: embolism venous,deep vein thrombosis and used Rivaroxaban (dosage: NA) starting NS. After starting Rivaroxaban the patient began experiencing various side effects, including: Venous Occlusion, Venous ThrombosisAdditional drugs used concurrently: NA. Although Rivaroxaban demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Venous Occlusion, may still occur.
Rivaroxaban Side Effect Report#9921363
Haemorrhage, Anaemia, Diverticulum, Melaena
This Haemorrhage problem was reported by a pharmacist from US. A 75-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation,gout. On
Jan 23, 2014 this consumer started treatment with Rivaroxaban (dosage: NA). The following drugs were being taken at the same time:
  • Indomethacin (50 Tid Po)
When using Rivaroxaban, the patient experienced the following unwanted symptoms/side effects: Haemorrhage, Anaemia, Diverticulum, MelaenaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Haemorrhage, may become evident only after a product is in use by the general population.
Rivaroxaban Side Effect Report#9921206
Duodenal Ulcer Haemorrhage
This Duodenal Ulcer Haemorrhage side effect was reported by a pharmacist from US. A 71-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Rivaroxaban (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Rivaroxaban the consumer reported adverse symptoms, such as: Duodenal Ulcer HaemorrhageThese side effects may potentially be related to Rivaroxaban.
Rivaroxaban Side Effect Report#9916383
Arthralgia, Synovial Fluid Crystal Present
This is a report of a 48-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: atrial fibrillation, who was treated with Rivaroxaban (dosage: 1 Tablet, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Arthralgia, Synovial Fluid Crystal Present after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rivaroxaban treatment in female patients, resulting in Arthralgia side effect.
Rivaroxaban Side Effect Report#9916339
Hypoxia, Hypotension, Melaena, Nausea, Asthenia, Dizziness, Renal Injury
This report suggests a potential Rivaroxaban Hypoxia side effect(s) that can have serious consequences. A 69-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: deep vein thrombosis and used Rivaroxaban (dosage: NA) starting
Jan 28, 2014. After starting Rivaroxaban the patient began experiencing various side effects, including: Hypoxia, Hypotension, Melaena, Nausea, Asthenia, Dizziness, Renal InjuryAdditional drugs used concurrently:
  • Metoprolol Tartrate
  • Lasix
  • Glipizide
  • Claritin
  • Tricor
  • Asa
  • Crestor
  • Cozaar
The patient was hospitalized. Although Rivaroxaban demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypoxia, may still occur.
Rivaroxaban Side Effect Report#9913090
Catheter Site Haemorrhage, Gastrostomy, Asthenia, Aphasia
This Catheter Site Haemorrhage problem was reported by a health professional from US. A 62-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation. On NS this consumer started treatment with Rivaroxaban (dosage: 1 Tablet). The following drugs were being taken at the same time:
  • Lovenox 120 Mg
When using Rivaroxaban, the patient experienced the following unwanted symptoms/side effects: Catheter Site Haemorrhage, Gastrostomy, Asthenia, AphasiaThe patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Catheter Site Haemorrhage, may become evident only after a product is in use by the general population.
Rivaroxaban Side Effect Report#9908537
Atrial Fibrillation, Gastrointestinal Haemorrhage, Anaemia
This Atrial Fibrillation side effect was reported by a pharmacist from US. A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: cerebrovascular accident prophylaxis,coronary artery disease.The patient was prescribed Rivaroxaban (drug dosage: Recent), which was initiated on NS. Concurrently used drugs:
  • Clopidogrel (Chronic)
  • Asa 81mg Po Daily (81mg Po Daily?chronic)
.After starting to take Rivaroxaban the consumer reported adverse symptoms, such as: Atrial Fibrillation, Gastrointestinal Haemorrhage, AnaemiaThese side effects may potentially be related to Rivaroxaban. The patient was hospitalized.
Rivaroxaban Side Effect Report#9908458
Tongue Haemorrhage, Shock
This is a report of a 74-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: deep vein thrombosis, who was treated with Rivaroxaban (dosage: NA, start time:
Jul 03, 2013), combined with: NA. and developed a serious reaction and side effect(s): Tongue Haemorrhage, Shock after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rivaroxaban treatment in male patients, resulting in Tongue Haemorrhage side effect. The patient was hospitalized.
Rivaroxaban Side Effect Report#9904508
Brain Oedema, Hypertension, Thalamus Haemorrhage, Intraventricular Haemorrhage
This report suggests a potential Rivaroxaban Brain Oedema side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: atrial fibrillation and used Rivaroxaban (dosage: NA) starting NS. After starting Rivaroxaban the patient began experiencing various side effects, including: Brain Oedema, Hypertension, Thalamus Haemorrhage, Intraventricular HaemorrhageAdditional drugs used concurrently: NA.The patient was hospitalized. Although Rivaroxaban demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Brain Oedema, may still occur.
Rivaroxaban Side Effect Report#9902586
Rash
This Rash problem was reported by a health professional from SG. A 81-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Rivaroxaban (dosage: NA). The following drugs were being taken at the same time: NA. When using Rivaroxaban, the patient experienced the following unwanted symptoms/side effects: RashAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rash, may become evident only after a product is in use by the general population.
Rivaroxaban Side Effect Report#9902513
Basilar Artery Thrombosis, Ischaemic Stroke
This Basilar Artery Thrombosis side effect was reported by a physician from IT. A 86-year-old female patient (weight:NA) experienced the following symptoms/conditions: atrial fibrillation,international normalised ratio fluctuation.The patient was prescribed Rivaroxaban (drug dosage: NA), which was initiated on
Jan 07, 2014. Concurrently used drugs: NA..After starting to take Rivaroxaban the consumer reported adverse symptoms, such as: Basilar Artery Thrombosis, Ischaemic StrokeThese side effects may potentially be related to Rivaroxaban.
Rivaroxaban Side Effect Report#9890765
Haemarthrosis
This is a report of a 81-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: atrial fibrillation, who was treated with Rivaroxaban (dosage: 1 Qhs/bedtime Oral, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Haemarthrosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rivaroxaban treatment in male patients, resulting in Haemarthrosis side effect. The patient was hospitalized.
Rivaroxaban Side Effect Report#9890736
Capillary Leak Syndrome
This report suggests a potential Rivaroxaban 20mg Capillary Leak Syndrome side effect(s) that can have serious consequences. A 78-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Rivaroxaban 20mg (dosage: 1 Tab Qd Oral) starting NS. After starting Rivaroxaban 20mg the patient began experiencing various side effects, including: Capillary Leak SyndromeAdditional drugs used concurrently: NA.The patient was hospitalized. Although Rivaroxaban 20mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Capillary Leak Syndrome, may still occur.
Rivaroxaban Side Effect Report#9887474
Anaemia, Pleural Effusion, Shock Haemorrhagic, Haemothorax
This Anaemia problem was reported by a pharmacist from US. A 64-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Rivaroxaban (dosage: NA). The following drugs were being taken at the same time:
  • Atorvastatin
  • Fenofibrate
  • Fish Oil
When using Rivaroxaban, the patient experienced the following unwanted symptoms/side effects: Anaemia, Pleural Effusion, Shock Haemorrhagic, HaemothoraxThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anaemia, may become evident only after a product is in use by the general population.
Rivaroxaban Side Effect Report#9871404
Haemorrhage
This Haemorrhage side effect was reported by a pharmacist from US. A 36-year-old male patient (weight:NA) experienced the following symptoms/conditions: pulmonary embolism.The patient was prescribed Rivaroxaban (drug dosage: NA), which was initiated on
Jan 13, 2014. Concurrently used drugs: NA..After starting to take Rivaroxaban the consumer reported adverse symptoms, such as: HaemorrhageThese side effects may potentially be related to Rivaroxaban.
Rivaroxaban Side Effect Report#9861912
Haemorrhagic Cerebral Infarction, Confusional State
This is a report of a 88-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: prophylaxis, who was treated with Rivaroxaban (dosage: NA, start time:
Dec 03, 2013), combined with:
  • Nebivolol
  • Amiodarone
  • Spironolactone
  • Ceftriaxone
  • Vancomycin
  • Furosemide
and developed a serious reaction and side effect(s): Haemorrhagic Cerebral Infarction, Confusional State after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rivaroxaban treatment in female patients, resulting in Haemorrhagic Cerebral Infarction side effect. The patient was hospitalized.


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The appearance of Rivaroxaban on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Rivaroxaban reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    More About Rivaroxaban

    Side Effects reported to FDA: 406

    Rivaroxaban safety alerts: No

    Reported deaths: 35

    Reported hospitalizations: 255

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