Berinert (human c1-esterase inhibitor) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Human c1-esterase inhibitor

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 2010 to June 2026, FDA received 4,705 adverse event reports that name Berinert. In these reports the drug is a suspect or interacting product.

In the same period, 1,198 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 791 reports in the 12 months to June 2026 and 1,099 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, 791 (0.1%) name Berinert. Reports from other health professionals were 55.7% of the reports that name Berinert and 19.7% 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 Berinert 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 173 reports that name Berinert.
In January to March 2026, FDA received 138.
In April to June 2025, FDA received 240.

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 376 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 4,695 of the 4,705 reports (99.8%).

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 376 terms.

Reaction terms in the reports that name Berinert, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,705 reports
Off label useused for a purpose or in a way not on the label	1,299	27.6%
Hereditary angioedema	1,286	27.3%
Drug ineffectivethe medicine did not work as expected	929	19.7%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	863	18.3%
Psoriatic arthropathy	760	16.2%
Systemic lupus erythematosuslupus, an autoimmune disease	754	16%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	738	15.7%
Product use in unapproved indicationused for a purpose not on the label	737	15.7%
Intentional product use issuedeliberate use not as intended	734	15.6%
Pericarditisinflammation of the sac around the heart	729	15.5%
Infusion related reactiona reaction during or soon after an infusion	727	15.5%
Pemphigus	725	15.4%
Swelling	725	15.4%
Type 2 diabetes mellitustype 2 diabetes	722	15.3%
Painpain, site not specified	715	15.2%
Confusional stateconfusion	704	15%
Hypoaesthesianumbness	696	14.8%
General physical health deteriorationgeneral decline in health	694	14.8%
Synovitis	694	14.8%
Hypertensionhigh blood pressure	692	14.7%
Astheniaweakness or lack of energy	688	14.6%
Condition aggravatedthe condition being treated got worse	688	14.6%
Bursitis	684	14.5%
Folliculitis	682	14.5%
Glossodynia	682	14.5%
Arthropathy	680	14.5%
Arthralgiajoint pain	672	14.3%
Breast cancer stage III	672	14.3%
Rashskin rash	664	14.1%
Dizzinesslight-headedness or unsteadiness	663	14.1%
Epilepsy	659	14%
Fatiguetiredness	654	13.9%
C-reactive protein increased	652	13.9%
Wound	651	13.8%
Gastrooesophageal reflux diseaseacid reflux	650	13.8%
Helicobacter infection	649	13.8%
Duodenal ulcer perforation	648	13.8%
Hand deformity	641	13.6%
Abdominal discomfortstomach discomfort	634	13.5%
Blood cholesterol increasedraised cholesterol	632	13.4%
Inflammation	630	13.4%
Blepharospasm	629	13.4%
Weight increasedweight gain	628	13.3%
Drug intolerancethe medicine was not tolerated	626	13.3%
Abdominal pain upperupper stomach pain	624	13.3%
Anti-cyclic citrullinated peptide antibody positive	624	13.3%
Joint swellinga swollen joint	624	13.3%
Alopeciahair loss	620	13.2%
Blistera blister	620	13.2%
Hepatic enzyme increasedraised liver enzymes	618	13.1%

Download all 376 terms of Berinert (CSV)

The counts add to more than 4,705 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 Human c1-esterase inhibitor with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Human c1-esterase inhibitor	Generic name	669
Berinert (this page)	Brand name	4,705
Cinryze	Brand name	2,659
Haegarda	Brand name	4,766

Sum of the separately reported names: 12,799. 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 Berinert, 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	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2010	10	9	2	1	5	1	0	2	1
2011	23	21	0	0	6	0	0	16	2
2012	41	38	3	2	16	0	0	22	3
2013	48	46	2	7	22	0	0	29	2
2014	113	110	3	3	44	1	0	67	3
2015	226	162	4	7	81	2	0	94	64
2016	266	189	3	1	69	1	1	125	77
2017	298	227	6	2	78	0	0	166	71
2018	189	148	4	1	32	0	0	124	41
2019	337	186	2	3	38	1	0	159	151
2020	177	115	5	6	31	3	0	103	62
2021	134	102	3	15	39	0	0	78	32
2022	183	158	7	6	55	2	0	128	25
2023	244	218	42	41	107	30	27	182	26
2024	624	607	430	371	417	350	328	534	17
2025	1,157	1,135	741	680	749	654	692	989	22
2026	635	623	368	332	398	316	352	553	12

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 Berinert, 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 Berinert, by the year in which FDA received them
Year	Reports
2010	6
2011	29
2012	52
2013	37
2014	126
2015	229
2016	268
2017	318
2018	216
2019	336
2020	168
2021	156
2022	230
2023	299
2024	884
2025	1,040
2026	311

Reports that name Berinert, 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 Berinert
Age	Reports	Share
Under 2	8	0.2%
2 to 11	79	1.7%
12 to 17	109	2.3%
18 to 44	2,138	45.4%
45 to 64	642	13.6%
65 to 74	172	3.7%
75 and over	135	2.9%
Age not given	1,422	30.2%

Sex of the patient in the reports that name Berinert
Sex	Reports	Share
Female	3,540	75.2%
Male	661	14%
Unknown or not given	504	10.7%

Type of reporter in the reports that name Berinert
Reporter	Reports	Share
Physician	472	10%
Pharmacist	518	11%
Other health professional	2,622	55.7%
Lawyer	0	0%
Consumer or non-health professional	1,062	22.6%
Not given	31	0.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 43.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Berinert record
Indication as recorded (MedDRA)	Reports	Share
Hereditary angioedema	1,804	38.3%
Prophylaxis	245	5.2%
Hereditary angioedema with c1 esterase inhibitor deficiency	88	1.9%
Foetal exposure during pregnancy	80	1.7%
Angioedema	51	1.1%
Hereditary angioedema with normal c1 esterase inhibitor	47	1%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,705 reports.

Drugs in the same reports

Other drugs that the reports of Berinert name, in any role, in order of name
Drug	Reports that name the two
Actemra	1,544
Botulinum toxin type a	1,556
Candesartan	1,498
Cimzia	1,474
Cosentyx	1,578
Desoximetasone	1,469
Folic acid	1,437
Leflunomide	1,514
Prednisone	1,504
Rituximab	1,461

The table has the 10 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

Human c1-esterase inhibitor same ingredient
Cinryze same ingredient
Haegarda same ingredient
Beovu next in the A to Z list
Beriplex P/N next in the A to Z list
Benzylpenicillin Potassium next in the A to Z list
Berotec next in the A to Z list
Benzylpenicillin next in the A to Z list
Besivance next in the A to Z list
Benzydamine next in the A to Z list
Besponsa next in the A to Z list
Benztropine mesylate next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for BerinertThe 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. Berinert: adverse event reports that FDA received. https://reportedreactions.com/drug/berinert/ 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 Berinert as a suspect or interacting product. The 1,198 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 Berinert 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 Berinert?

No. It is a count of what people reported to FDA: 4,705 reports from February 2010 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?

Other health professional (55.7%), consumer or non-health professional (22.6%) and pharmacist (11%). 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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