72/100 · Elevated
Manufactured by Janssen Pharmaceuticals, Inc.
Rivaroxaban Adverse Events: Hemorrhagic and Gastrointestinal Reactions Predominate
299,230 FDA adverse event reports analyzed
Last updated: 2026-05-12
RIVAROXABAN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Pharmaceuticals, Inc.. Based on analysis of 299,230 FDA adverse event reports, RIVAROXABAN has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for RIVAROXABAN include GASTROINTESTINAL HAEMORRHAGE, OFF LABEL USE, HAEMORRHAGE, DYSPNOEA, EPISTAXIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RIVAROXABAN.
Rivaroxaban has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 299,230 adverse event reports for this medication, which is primarily manufactured by Janssen Pharmaceuticals, Inc..
The most commonly reported adverse events include Gastrointestinal Haemorrhage, Off Label Use, Haemorrhage. Of classified reports, 84.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Hemorrhagic events, including gastrointestinal and intracranial hemorrhage, are the most frequent and serious adverse reactions.
Gastrointestinal symptoms such as diarrhea, nausea, and abdominal pain are also commonly reported. Death and pulmonary embolism are significant but less frequent adverse events.
Patients taking Rivaroxaban should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Rivaroxaban can cause significant bleeding, and patients should be monitored for signs of hemorrhage, especially when used in combination with other anticoagulants or antiplatelet agents. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Rivaroxaban received a safety concern score of 72/100 (elevated concern). This is based on a 84.0% serious event ratio across 203,227 classified reports. The score accounts for 299,230 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Male: 91,403, Female: 91,223, Unknown: 1,139. The most frequently reported age groups are age 75 (4,645 reports), age 70 (4,519 reports), age 78 (4,508 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 203,227 classified reports for RIVAROXABAN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Rivaroxaban can cause significant bleeding, and patients should be monitored for signs of hemorrhage, especially when used in combination with other anticoagulants or antiplatelet agents.
If you are taking Rivaroxaban, here are important things to know. The most commonly reported side effects include gastrointestinal haemorrhage, off label use, haemorrhage, dyspnoea, epistaxis. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Be cautious when using rivaroxaban with other anticoagulants or antiplatelet drugs to avoid excessive bleeding. Monitor for signs of gastrointestinal bleeding, such as black stools or vomiting blood, and report any unusual symptoms to your healthcare provider immediately. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor the safety of rivaroxaban and has not issued any additional warnings beyond those already in place.
The FDA has received approximately 299,230 adverse event reports associated with Rivaroxaban. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Rivaroxaban include Gastrointestinal Haemorrhage, Off Label Use, Haemorrhage, Dyspnoea, Epistaxis. By volume, the top reported reactions are: Gastrointestinal Haemorrhage (21,559 reports), Off Label Use (7,808 reports), Haemorrhage (7,713 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Rivaroxaban.
Out of 203,227 classified reports, 170,661 (84.0%) were classified as serious and 32,566 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Rivaroxaban break down by patient sex as follows: Male: 91,403, Female: 91,223, Unknown: 1,139. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Rivaroxaban adverse events are: age 75: 4,645 reports, age 70: 4,519 reports, age 78: 4,508 reports, age 77: 4,468 reports, age 80: 4,393 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Rivaroxaban adverse event reports is Janssen Pharmaceuticals, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Rivaroxaban include: Fatigue, Death, Fall, Pulmonary Embolism, Drug Ineffective. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Rivaroxaban to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Rivaroxaban has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Hemorrhagic events, including gastrointestinal and intracranial hemorrhage, are the most frequent and serious adverse reactions.
Key safety signals identified in Rivaroxaban's adverse event data include: Hemorrhagic events (hemorrhage, epistaxis, fall, etc.). Gastrointestinal reactions (gastrointestinal hemorrhage, diarrhea, nausea, etc.). Death and pulmonary embolism. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Rivaroxaban can cause significant bleeding, and patients should be monitored for signs of hemorrhage, especially when used in combination with other anticoagulants or antiplatelet agents. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Rivaroxaban.
Be cautious when using rivaroxaban with other anticoagulants or antiplatelet drugs to avoid excessive bleeding. Monitor for signs of gastrointestinal bleeding, such as black stools or vomiting blood, and report any unusual symptoms to your healthcare provider immediately.
Rivaroxaban has 299,230 adverse event reports on file with the FDA. Gastrointestinal symptoms such as diarrhea, nausea, and abdominal pain are also commonly reported. The volume of reports for Rivaroxaban reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of rivaroxaban and has not issued any additional warnings beyond those already in place. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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