Savaysaedoxaban
According to the FDA label: SAVAYSA is a factor Xa inhibitor indicated: To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) ( 1.1 ) Limitation of Use for NVAF SAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg) ( 1.1 ) SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10…
6,303 adverse event reports submitted to the FDA (2010–2026)
Top Reported Adverse Events
The most frequently reported events in association with Savaysa in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Anaemia 301 reports
A condition where there are too few healthy red blood cells to carry enough oxygen, often causing tiredness and paleness. Also spelled anemia in American English.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 286 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Renal Impairment 278 reports
Reduced kidney function. Renal means related to the kidneys. This is a broad term for kidneys not working as well as normal.
Full definition in the glossary →Dyspnoea 260 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Cardiac Failure 253 reports
A condition where the heart cannot pump blood as well as it should, often called heart failure.
Full definition in the glossary →- Cerebral Infarction 252 reports
Nausea 230 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 205 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →Atrial Fibrillation 197 reports
An irregular, often rapid heart rhythm.
Full definition in the glossary →Diarrhoea 194 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Fall 192 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Gastrointestinal Haemorrhage 187 reports
Bleeding somewhere in the digestive tract, such as the stomach or intestines. Also spelled hemorrhage in American English.
Full definition in the glossary →Fatigue 185 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Dizziness 179 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Acute Kidney Injury 178 reports
A sudden drop in how well the kidneys are working. It is often temporary and can have many causes.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 2,901 |
| Female | 2,644 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 261 |
| 18-34 | 42 |
| 35-49 | 125 |
| 50-64 | 586 |
| 65-74 | 1,131 |
| 75+ | 2,741 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Savaysa. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 3,328 |
| Hospitalization | 3,326 |
| Death | 848 |
| Non-Serious | 684 |
| Life-Threatening | 419 |
| Disability | 166 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Savaysa. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2010 | 1 |
| 2015 | 345 |
| 2016 | 253 |
| 2017 | 130 |
| 2018 | 77 |
| 2019 | 95 |
| 2020 | 116 |
| 2021 | 563 |
| 2022 | 1,151 |
| 2023 | 1,177 |
| 2024 | 1,187 |
| 2025 | 991 |
| 2026 (partial) | 217 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Savaysa
In FDA adverse event reports that mention Savaysa, these medications appeared most often in the same report.
- Bisoprolol (1,206 reports)
- Furosemide (877 reports)
- Pantoprazole (538 reports)
- Spironolactone (522 reports)
- Lansoprazole (405 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026