Recombinate (antihemophilic factor recombinant) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Antihemophilic factor recombinant
Also reported as: Recombinate Inj

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 February 2004 to June 2026, FDA received 755 adverse event reports that name Recombinate. In these reports the drug is a suspect or interacting product.

In the same period, 124 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 62 reports in the 12 months to June 2026 and 37 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, 62 (under 0.1%) name Recombinate. Reports for female patients were 2.3% of the reports that name Recombinate 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 Recombinate 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 11 reports that name Recombinate.
In January to March 2026, FDA received 30.
In April to June 2025, FDA received 12.

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 44 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 707 of the 755 reports (93.6%).

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 all 44 terms.

Reaction terms in the reports that name Recombinate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 755 reports
Haemarthrosis	270	35.8%
Haemorrhagebleeding	260	34.4%
Muscle haemorrhage	65	8.6%
Arthralgiajoint pain	57	7.5%
Joint injury	50	6.6%
Limb injury	49	6.5%
Drug ineffectivethe medicine did not work as expected	43	5.7%
Falla fall	40	5.3%
Anti factor VIII antibody positive	37	4.9%
Spontaneous haemorrhage	37	4.9%
Contusiona bruise	34	4.5%
Extra dose administered	33	4.4%
Painpain, site not specified	32	4.2%
Product use issuea problem in how the product was used	29	3.8%
Epistaxisnosebleed	25	3.3%
Factor VIII inhibition	24	3.2%
Joint swellinga swollen joint	24	3.2%
Arthropathy	23	3%
Inappropriate schedule of product administrationthe product was taken at the wrong times	22	2.9%
Peripheral swellingswelling of the arms or legs	18	2.4%
Product availability issuethe product was not available	17	2.3%
Mouth haemorrhage	16	2.1%
Product dose omission issuea dose was missed	16	2.1%
Swelling	13	1.7%
Head injurya head injury	12	1.6%
No adverse eventno adverse event was reported	12	1.6%
Gastrointestinal haemorrhagebleeding in the stomach or bowel	11	1.5%
Pain in extremitypain in an arm or leg	11	1.5%
Road traffic accidenta road accident	11	1.5%
Deaththe patient died; cause not stated by this term	10	1.3%
Ligament sprain	10	1.3%
Blood urine present	9	1.2%
Gait disturbancedifficulty walking	9	1.2%
Back pain	8	1.1%
Limb discomfortdiscomfort in an arm or leg	8	1.1%
Poor venous access	8	1.1%
Haematomaa collection of blood under the skin or in tissue	7	0.9%
Hospitalisationadmission to hospital	7	0.9%
Injurya physical injury	7	0.9%
Muscle strain	7	0.9%
Product distribution issue	7	0.9%
Gingival bleedingbleeding gums	6	0.8%
Joint stiffnessa stiff joint	5	0.7%
Skin lacerationa cut in the skin	5	0.7%

Download all 44 terms of Recombinate (CSV)

The counts add to more than 755 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 Antihemophilic factor recombinant with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Novoeight	Brand name	459
Recombinate (this page)	Brand name	755

Sum of the separately reported names: 1,214. 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 Recombinate, 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	20	19	0	1	7	0	12	1
2005	13	13	0	0	2	1	12	0
2006	16	15	3	2	6	0	10	1
2007	7	4	1	0	4	0	0	3
2008	6	4	2	0	2	0	1	2
2009	5	5	2	0	2	0	1	0
2010	10	10	3	1	2	0	7	0
2011	7	7	2	0	3	0	5	0
2012	3	2	0	0	1	0	2	1
2013	10	9	0	0	5	0	4	1
2014	24	21	1	0	2	0	18	3
2015	14	11	0	0	2	0	11	3
2016	17	14	2	0	3	0	11	3
2017	15	11	0	1	2	0	10	4
2018	33	32	1	0	5	0	31	1
2019	47	33	2	0	4	0	31	14
2020	93	74	4	0	8	0	71	19
2021	72	67	2	0	12	0	59	5
2022	93	91	4	0	10	0	83	2
2023	38	30	0	0	6	0	28	8
2024	73	70	2	1	14	0	68	3
2025	82	76	0	0	20	0	70	6
2026	57	50	0	0	17	0	43	7

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 Recombinate, 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 Recombinate, by the year in which FDA received them
Year	Reports
2004	20
2005	13
2006	16
2007	6
2008	6
2009	6
2010	6
2011	11
2012	4
2013	10
2014	23
2015	14
2016	17
2017	15
2018	36
2019	57
2020	163
2021	77
2022	95
2023	47
2024	33
2025	39
2026	41

Reports that name Recombinate, 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 Recombinate
Age	Reports	Share
Under 2	13	1.7%
2 to 11	40	5.3%
12 to 17	51	6.8%
18 to 44	298	39.5%
45 to 64	88	11.7%
65 to 74	40	5.3%
75 and over	10	1.3%
Age not given	215	28.5%

Sex of the patient in the reports that name Recombinate
Sex	Reports	Share
Female	17	2.3%
Male	605	80.1%
Unknown or not given	133	17.6%

Type of reporter in the reports that name Recombinate
Reporter	Reports	Share
Physician	123	16.3%
Pharmacist	62	8.2%
Other health professional	128	17%
Lawyer	1	0.1%
Consumer or non-health professional	421	55.8%
Not given	20	2.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 82.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Recombinate record
Indication as recorded (MedDRA)	Reports	Share
Factor viii deficiency	187	24.8%
Haemorrhage	71	9.4%
Haemophilia	17	2.3%
Prophylaxis	17	2.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 755 reports.

Drugs in the same reports

Other drugs that the reports of Recombinate name, in any role, in order of name
Drug	Reports that name the two
Advate	41
Hemlibra	17
Sodium chloride	6

The table has the 3 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

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.

Pages near this one

Novoeight same ingredient
Reclast next in the A to Z list
Recorlev next in the A to Z list
Rebyota next in the A to Z list
Reductil next in the A to Z list
Reboxetine next in the A to Z list
Refacto next in the A to Z list
Reblozyl next in the A to Z list
Reflex next in the A to Z list
Rebif Rebidose next in the A to Z list
Refresh Celluvisc next in the A to Z list
Rebif next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for RecombinateThe 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. Recombinate: adverse event reports that FDA received. https://reportedreactions.com/drug/recombinate/ 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 Recombinate as a suspect or interacting product. The 124 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 Recombinate 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 Recombinate?

No. It is a count of what people reported to FDA: 755 reports from February 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?

Consumer or non-health professional (55.8%), other health professional (17%) and physician (16.3%). 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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