85/100 · Critical
Manufactured by Amneal Pharmaceuticals of New York LLC
High Safety Concerns with Apixaban, Particularly for Serious Adverse Events
106,298 FDA adverse event reports analyzed
Last updated: 2026-05-12
APIXABAN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals of New York LLC. Based on analysis of 106,298 FDA adverse event reports, APIXABAN has a safety score of 85 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 APIXABAN include ATRIAL FIBRILLATION, DYSPNOEA, CEREBROVASCULAR ACCIDENT, THROMBOSIS, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for APIXABAN.
Apixaban has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 106,298 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Of New York Llc.
The most commonly reported adverse events include Atrial Fibrillation, Dyspnoea, Cerebrovascular Accident. Of classified reports, 95.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Apixaban is associated with a high number of serious adverse events, particularly thrombosis and hemorrhage.
The drug shows a wide range of reactions, indicating potential for diverse side effects. A significant portion of adverse events are related to cardiovascular issues, including atrial fibrillation and cardiac disorders.
Patients taking Apixaban should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Apixaban can interact with other anticoagulants and may increase the risk of bleeding. Patients should avoid certain drugs known to interact with it. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Apixaban received a safety concern score of 85/100 (high concern). This is based on a 95.7% serious event ratio across 62,646 classified reports. The score accounts for 106,298 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 30,594, Female: 27,064, Unknown: 20. The most frequently reported age groups are age 76 (1,604 reports), age 79 (1,543 reports), age 75 (1,535 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 62,646 classified reports for APIXABAN:
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.
Apixaban can interact with other anticoagulants and may increase the risk of bleeding. Patients should avoid certain drugs known to interact with it.
If you are taking Apixaban, here are important things to know. The most commonly reported side effects include atrial fibrillation, dyspnoea, cerebrovascular accident, thrombosis, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Consult healthcare providers before starting or stopping Apixaban to discuss potential risks and benefits. Be aware of signs of serious adverse events such as unexplained bleeding, chest pain, or shortness of breath, and seek medical attention 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 Apixaban's safety profile, and regulatory actions may be taken based on ongoing data.
The FDA has received approximately 106,298 adverse event reports associated with Apixaban. 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 Apixaban include Atrial Fibrillation, Dyspnoea, Cerebrovascular Accident, Thrombosis, Off Label Use. By volume, the top reported reactions are: Atrial Fibrillation (3,970 reports), Dyspnoea (3,599 reports), Cerebrovascular Accident (3,508 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Apixaban.
Out of 62,646 classified reports, 59,940 (95.7%) were classified as serious and 2,706 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 Apixaban break down by patient sex as follows: Male: 30,594, Female: 27,064, Unknown: 20. 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 Apixaban adverse events are: age 76: 1,604 reports, age 79: 1,543 reports, age 75: 1,535 reports, age 77: 1,531 reports, age 80: 1,513 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 Apixaban adverse event reports is Amneal Pharmaceuticals Of New York Llc. 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 Apixaban include: Cardiac Disorder, Death, Fall, Fatigue, Dizziness. 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 Apixaban 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.
Apixaban has a safety concern score of 85 out of 100 (high 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. Apixaban is associated with a high number of serious adverse events, particularly thrombosis and hemorrhage.
Key safety signals identified in Apixaban's adverse event data include: High incidence of thrombosis and hemorrhage, indicating potential for serious cardiovascular events.. Atrial fibrillation and cardiac disorders are frequent, suggesting a risk of arrhythmias and heart failure.. A wide range of reactions, including gastrointestinal and respiratory issues, indicating a broad safety profile.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Apixaban can interact with other anticoagulants and may increase the risk of bleeding. Patients should avoid certain drugs known to interact with it. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Apixaban.
Consult healthcare providers before starting or stopping Apixaban to discuss potential risks and benefits. Be aware of signs of serious adverse events such as unexplained bleeding, chest pain, or shortness of breath, and seek medical attention immediately.
Apixaban has 106,298 adverse event reports on file with the FDA. The drug shows a wide range of reactions, indicating potential for diverse side effects. The volume of reports for Apixaban reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Apixaban's safety profile, and regulatory actions may be taken based on ongoing data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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