Brand name · Antihemophilic factor (human)
Xyntha: adverse event reports filed with FDA
747 reports list it as a suspect or interacting product, 2009–2026.
- 747
- reports as suspect product
- 0% of all reports · about 44 a year
- 88
- reports, 12 months to June 2026
- 104 in the 12 months before
- 82.5%
- marked serious by the reporter
- 57.4% across all reports
- 9.1%
- record death among outcomes, as reported
- 68 reports · not verified by FDA
Between September 2009 and June 2026, 747 adverse event reports received by FDA list the brand name Xyntha (antihemophilic factor (human)) as a suspect or interacting product. Reports that mention it only as a concomitant medication (84) are left out of every figure here.
In the 12 months to June 2026, 88 reports listed it, down 15% from 104 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 44 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are haemorrhage (25.8%), haemarthrosis (12.4%) and arthralgia (9.5%). A report can list several reactions, so shares add to more than 100%; 206 different terms appear across these reports. Haemorrhage is recorded in 25.8% of these reports, against 0.5% of all reports in the database.
82.5% of the reports are marked serious by the reporter; 9.1% record death among the outcomes and 25% record hospitalisation, as reported. 50.9% of the reports came from consumers, and the largest patient age group is 18 to 44 (33.9%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Xyntha reports recording the termall reports in the database
- Haemorrhagebleeding25.8%193
- Haemarthrosis12.4%93
- Arthralgiajoint pain9.5%71
- Joint swellinga swollen joint7.5%56
- Off label useused for a purpose or in a way not on the label6%45
- Factor VIII inhibition5.1%38
- Falla fall3.6%27
- Deaththe patient died; cause not stated by this term3.2%24
- Drug ineffectivethe medicine did not work as expected2.9%22
- Painpain, site not specified2.7%20
- Joint injury2.5%19
- Device leakagethe device leaked2%15
- Ecchymosis2%15
- Haemophilic arthropathy2%15
- Contusiona bruise1.9%14
- Disease complication1.9%14
- Pain in extremitypain in an arm or leg1.9%14
- Gingival bleedingbleeding gums1.7%13
- Haematomaa collection of blood under the skin or in tissue1.7%13
- Headachehead pain1.7%13
- Joint range of motion decreasedreduced movement of a joint1.7%13
- Peripheral swellingswelling of the arms or legs1.7%13
- Cerebral haemorrhage1.6%12
- Dizzinesslight-headedness or unsteadiness1.6%12
- Pyrexiafever1.5%11
- Injurya physical injury1.3%10
- Limb injury1.3%10
- Mobility decreasedreduced ability to move about1.3%10
- Coughcough1.2%9
- Knee arthroplasty1.2%9
Top 30 of 206 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the share of all reports in the database; it describes the reports, not the patients. 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."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 58.4% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Factor viii deficiency | 267 | 35.7% |
| Haemophilia | 61 | 8.2% |
| Haemorrhage | 33 | 4.4% |
| Coagulation factor viii level | 11 | 1.5% |
| Prophylaxis | 10 | 1.3% |
| Hemophilia a | 5 | 0.7% |
The indication field is filled in by the reporter and is often blank; shares are of all 747 reports.
In context
| Measure | Xyntha | All reports |
|---|---|---|
| Reports as suspect product | 747 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 88 | 1,332,454 |
| Marked serious | 82.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 91 | 91 |
| Hospitalisation recorded, per 1,000 reports | 250 | 213 |
| Consumer-filed share | 50.9% | 45.8% |
| Top term, share of reports | Haemorrhage 25.8% | 0.5% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."
Questions about Xyntha reports
How many adverse event reports has FDA received for Xyntha?
747 reports list Xyntha as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 88 of them arrived in the latest 12 months. Another 84 list it only as a concomitant medication.
What reactions are recorded in Xyntha reports?
haemorrhage (25.8%), haemarthrosis (12.4%), arthralgia (9.5%), joint swelling (7.5%) and off label use (6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Xyntha was responsible.
How serious are the reports?
82.5% are marked serious by the reporter. Among the outcomes recorded, 9.1% of reports include death and 25% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (50.9%), other health professional (28%) and physician (16.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Xyntha rising?
88 reports in the 12 months to June 2026, down 15% from 104 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Xyntha was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Xyntha?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Xyntha as a suspect or interacting product; reports listing it only as a concomitant medication (84) are excluded. 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.