Pharmacologic class (EPC) · 7 drug pages

Factor Xa inhibitor: adverse event reports filed with FDA

329,539 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

329,539
reports across the class: 1.6% of all reports; 12,649
reports, 12 months to June 2026: 17,103 in the 12 months before; 81.6%
marked serious by the reporter: 57.4% across all reports; 7
drugs with a page: brand and generic names counted separately

Factor Xa inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 7 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 329,539 adverse event reports received by FDA, 1.6% of the database, from January 2004 to June 2026.

12,649 reports arrived in the 12 months to June 2026, down 26% from 17,103 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 81.6% of the class's reports are marked serious, 15.7% record death among the outcomes and 39.4% record hospitalisation, as reported.

Across the class the reactions recorded most often are gastrointestinal haemorrhage (7.9%), death (6.9%) and haemorrhage (3.9%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
XareltoRivaroxaban	brand	133,243	1,512	86%	Gastrointestinal haemorrhage
EliquisApixaban	brand	125,107	5,574	69.4%	Death
Apixaban	generic	46,029	3,513	95.9%	Cerebrovascular accident
Rivaroxaban	generic	16,490	1,610	96.7%	Drug interaction
ArixtraFondaparinux sodium	brand	5,361	46	86.2%	Haematoma
Edoxaban tosylate	generic	2,543	387	98.7%	Cerebral infarction
SavaysaEdoxaban tosylate	brand	766	7	33.3%	Gastrointestinal haemorrhage

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Gastrointestinal haemorrhagebleeding in the stomach or bowel7.9%26,147
Deaththe patient died; cause not stated by this term6.9%22,583
Haemorrhagebleeding3.9%12,901
Cerebrovascular accidentstroke3.8%12,533
Off label useused for a purpose or in a way not on the label3.5%11,404
Thrombosis2.9%9,488
Falla fall2.9%9,442
Epistaxisnosebleed2.9%9,413
Anaemialow red blood cells2.6%8,725
Atrial fibrillationan irregular heart rhythm2.6%8,442
Dyspnoeashortness of breath2.5%8,326
Pulmonary embolisma blood clot in the lung2.5%8,147
Dizzinesslight-headedness or unsteadiness2.1%6,911
Deep vein thrombosisa blood clot in a deep vein2%6,669
Haematuriablood in the urine2%6,541
Rectal haemorrhage1.9%6,249
Fatiguetiredness1.9%6,126
Cerebral haemorrhage1.8%6,039
Drug ineffectivethe medicine did not work as expected1.8%5,835
Headachehead pain1.7%5,685
Adverse eventan unwanted medical event, type not specified1.7%5,643
Drug interactionan interaction between medicines1.7%5,596
Cardiac disorder1.7%5,584
Acute kidney injurysudden loss of kidney function1.7%5,555
Upper gastrointestinal haemorrhage1.6%5,292

Solid bar: share of all class reports. Hollow bar: the median share across the 7 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death15.7%51,642

Life-threatening4.6%15,086

Hospitalisation (initial or prolonged)39.4%129,810

Disability1.7%5,749

Congenital anomaly0.1%351

Other serious52.7%173,681

Not serious18.4%60,533

Patient age

Under 20.1%165

2 to 110%160

12 to 170.1%275

18 to 443%9,877

45 to 6412.6%41,506

65 to 7417.4%57,359

75 and over32.9%108,557

Age not given33.9%111,640

Who reported

Physician24.1%79,415

Pharmacist7.5%24,766

Other health professional14.3%47,057

Lawyer0.3%1,116

Consumer or non-health professional53.2%175,332

Not given0.6%1,853

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Factor Xa inhibitor reports

Which drugs are in the Factor Xa inhibitor class on this site?

Xarelto, Eliquis, Apixaban, Rivaroxaban, Arixtra and Edoxaban tosylate and 1 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

329,539 reports through June 2026, 12,649 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

gastrointestinal haemorrhage (7.9%), death (6.9%), haemorrhage (3.9%), cerebrovascular accident (3.8%) and off label use (3.5%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.