Feiba (anti-inhibitor coagulant complex) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Feiba
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Anti-inhibitor coagulant complex
Also reported as: Feiba Nf, Feiba For Injection 1000, Feiba 500 Iu

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

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

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From August 2004 to June 2026, FDA received 1,145 adverse event reports that name Feiba. In these reports the drug is a suspect or interacting product.

In the same period, 165 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 47 reports in the 12 months to June 2026 and 30 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 47 (under 0.1%) name Feiba. Reports for female patients were 11.7% of the reports that name Feiba and 52.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Feiba is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 14 reports that name Feiba.
In January to March 2026, FDA received 5.
In April to June 2025, FDA received 7.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 59 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 1,070 of the 1,145 reports (93.4%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 59 terms.

Reaction terms in the reports that name Feiba, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,145 reports
Haemorrhagebleeding	166	14.5%
Drug ineffectivethe medicine did not work as expected	124	10.8%
Acquired haemophilia	75	6.6%
Pre-existing disease	72	6.3%
Therapy partial responder	72	6.3%
Haemarthrosis	68	5.9%
Deaththe patient died; cause not stated by this term	58	5.1%
Factor VIII inhibition	53	4.6%
Muscle haemorrhage	29	2.5%
Therapy responder	28	2.4%
Post procedural haemorrhage	26	2.3%
Falla fall	24	2.1%
Disseminated intravascular coagulation	22	1.9%
Haematomaa collection of blood under the skin or in tissue	21	1.8%
Anti factor VIII antibody positive	20	1.7%
Off label useused for a purpose or in a way not on the label	20	1.7%
Anti factor VIII antibody increased	19	1.7%
Joint swellinga swollen joint	17	1.5%
No adverse eventno adverse event was reported	17	1.5%
Pneumonialung infection	17	1.5%
Arthralgiajoint pain	16	1.4%
Gastrointestinal haemorrhagebleeding in the stomach or bowel	15	1.3%
Traumatic haemorrhage	15	1.3%
Renal failurekidney failure	14	1.2%
Device related infectionan infection related to the device	13	1.1%
Thrombosis	13	1.1%
Cardiac failureheart failure	12	1%
Cardio-respiratory arrestthe heart and breathing stopped	12	1%
Dyspnoeashortness of breath	12	1%
Myocardial infarctionheart attack	12	1%
Acute myocardial infarction	11	1%
Painpain, site not specified	11	1%
Cerebrovascular accidentstroke	10	0.9%
Drug effect decreasedthe medicine had less effect	10	0.9%
Headachehead pain	9	0.8%
Product storage errorthe product was stored wrongly	9	0.8%
Pyrexiafever	9	0.8%
Cerebral haemorrhage	8	0.7%
Cough	8	0.7%
Vomitingbeing sick	8	0.7%
Contusiona bruise	7	0.6%
Haemorrhagic stroke	7	0.6%
Multiple organ dysfunction syndromeseveral organs failing	7	0.6%
Spontaneous haemorrhage	7	0.6%
Haematuriablood in the urine	6	0.5%
Infectionan infection, type not specified	6	0.5%
Inhibiting antibodies	6	0.5%
Pain in extremitypain in an arm or leg	6	0.5%
Pulmonary embolisma blood clot in the lung	6	0.5%
Shock haemorrhagic	6	0.5%

Download all 59 terms of Feiba (CSV)

The counts add to more than 1,145 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Anti-inhibitor coagulant complex with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Anti-inhibitor coagulant complex	Generic name	505
Feiba (this page)	Brand name	1,145

Sum of the separately reported names: 1,650. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Feiba, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Other Serious (Important Medical Events)	Not serious
2004	2	2	0	0	1	0	2	0
2006	2	2	0	1	1	0	1	0
2007	2	2	0	1	1	0	1	0
2008	2	2	1	0	0	0	1	0
2009	8	7	1	0	4	0	4	1
2010	17	17	6	1	3	0	13	0
2011	52	51	15	2	14	0	29	1
2012	44	44	13	3	21	0	27	0
2013	62	56	8	4	15	1	39	6
2014	141	137	41	1	21	0	97	4
2015	123	121	29	4	24	0	89	2
2016	74	71	16	3	28	1	44	3
2017	66	62	14	5	21	2	48	4
2018	118	102	33	14	30	0	87	16
2019	103	99	37	2	30	0	87	4
2020	89	87	43	5	27	0	69	2
2021	60	52	19	1	11	2	44	8
2022	32	28	14	2	6	1	21	4
2023	33	32	3	4	10	0	28	1
2024	38	36	5	1	10	2	31	2
2025	52	47	8	2	16	0	41	5
2026	25	23	6	3	8	0	21	2

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Feiba, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Feiba, by the year in which FDA received them
Year	Reports
2004	1
2005	1
2006	2
2007	2
2008	1
2009	5
2010	22
2011	56
2012	46
2013	65
2014	137
2015	133
2016	77
2017	72
2018	115
2019	100
2020	90
2021	61
2022	32
2023	31
2024	34
2025	43
2026	19

Reports that name Feiba, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Feiba
Age	Reports	Share
Under 2	33	2.9%
2 to 11	127	11.1%
12 to 17	40	3.5%
18 to 44	109	9.5%
45 to 64	80	7%
65 to 74	63	5.5%
75 and over	124	10.8%
Age not given	569	49.7%

Sex of the patient in the reports that name Feiba
Sex	Reports	Share
Female	134	11.7%
Male	636	55.5%
Unknown or not given	375	32.8%

Type of reporter in the reports that name Feiba
Reporter	Reports	Share
Physician	409	35.7%
Pharmacist	86	7.5%
Other health professional	380	33.2%
Lawyer	0	0%
Consumer or non-health professional	254	22.2%
Not given	16	1.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 28.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Feiba record
Indication as recorded (MedDRA)	Reports	Share
Acquired haemophilia	185	16.2%
Factor viii deficiency	107	9.3%
Haemophilia	69	6%
Prophylaxis	64	5.6%
Haemorrhage	58	5.1%
Haemorrhage prophylaxis	31	2.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,145 reports.

Pages near this one

Anti-inhibitor coagulant complex same ingredient
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Felbamate next in the A to Z list
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Feburic next in the A to Z list
Felodipine next in the A to Z list
Fazaclo Odt next in the A to Z list
Femara next in the A to Z list
Fazaclo next in the A to Z list
Femhrt next in the A to Z list
Favipiravir next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for FeibaThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Feiba: adverse event reports that FDA received. https://reportedreactions.com/drug/feiba/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Feiba as a suspect or interacting product. The 165 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Feiba was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Feiba?

No. It is a count of what people reported to FDA: 1,145 reports from August 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (35.7%), other health professional (33.2%) and consumer or non-health professional (22.2%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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