Gammaplex (human immunoglobulin g) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Human immunoglobulin g
Class: Human immunoglobulin G

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.

Reports on file

From April 2011 to June 2026, FDA received 476 adverse event reports that name Gammaplex. In these reports the drug is a suspect or interacting product.

In the same period, 95 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 9 reports in the 12 months to June 2026 and 19 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Gammaplex 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 2 reports that name Gammaplex.
In January to March 2026, FDA received 4.
In April to June 2025, FDA received 2.

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

This list is partial.

It covers 424 of the 476 reports (89.1%).

The site keeps reaction terms only for years in which the drug has 12 or more reports.

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

Find a reaction term

The table shows all 33 terms.

Reaction terms in the reports that name Gammaplex, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 476 reports
Headachehead pain	89	18.7%
Off label useused for a purpose or in a way not on the label	69	14.5%
Nauseafeeling sick	52	10.9%
Infusion related reactiona reaction during or soon after an infusion	48	10.1%
Rashskin rash	36	7.6%
Chillschills or shivering	26	5.5%
Blood pressure increaseda raised blood pressure reading	25	5.3%
Vomitingbeing sick	25	5.3%
Pruritusitching	22	4.6%
Painpain, site not specified	21	4.4%
Dyspnoeashortness of breath	19	4%
Fatiguetiredness	18	3.8%
Meningitis aseptic	17	3.6%
Chest pain	16	3.4%
Migraine	14	2.9%
Back pain	13	2.7%
Pyrexiafever	13	2.7%
Urticariahives	13	2.7%
Chest discomfort	12	2.5%
Rash pruritican itchy rash	12	2.5%
Astheniaweakness or lack of energy	10	2.1%
Heart rate increaseda fast heart rate reading	10	2.1%
Hypertensionhigh blood pressure	9	1.9%
Myalgiamuscle pain	9	1.9%
Malaisegeneral feeling of being unwell	8	1.7%
Influenza like illnessflu-like symptoms	7	1.5%
Arthralgiajoint pain	6	1.3%
Neck pain	6	1.3%
Pain in extremitypain in an arm or leg	6	1.3%
Rash maculo-papulara rash of flat and raised spots	6	1.3%
Blistera blister	5	1.1%
Burning sensationa burning feeling	5	1.1%
Thrombosis	5	1.1%

Download all 33 terms of Gammaplex (CSV)

The counts add to more than 476 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 immunoglobulin g with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Human immunoglobulin g	Generic name	17,139
Gammaplex (this page)	Brand name	476
Hizentra	Brand name	22,916
Privigen	Brand name	8,718

Sum of the separately reported names: 49,249. 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 Gammaplex, 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	4	4	0	0	0	0	0	4	0
2011	10	10	0	0	6	4	0	4	0
2012	9	9	0	0	6	0	0	3	0
2013	10	10	0	1	3	0	0	6	0
2014	15	15	0	0	5	0	0	10	0
2015	30	11	0	0	2	0	0	9	19
2016	57	20	1	0	7	1	0	13	37
2017	57	23	2	0	11	0	0	11	34
2018	46	33	1	0	11	0	0	22	13
2019	51	39	0	1	11	2	1	31	12
2020	63	45	1	0	9	0	1	35	18
2021	32	16	0	1	4	0	0	13	16
2022	27	18	0	2	5	0	0	13	9
2023	20	11	0	0	3	0	0	7	9
2024	26	18	0	2	7	1	0	9	8
2025	11	11	1	0	6	0	0	6	0
2026	8	4	0	0	2	0	0	1	4

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 Gammaplex, 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 Gammaplex, by the year in which FDA received them
Year	Reports
2011	13
2012	10
2013	10
2014	15
2015	32
2016	56
2017	57
2018	47
2019	49
2020	67
2021	30
2022	29
2023	20
2024	24
2025	11
2026	6

Reports that name Gammaplex, 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 Gammaplex
Age	Reports	Share
Under 2	3	0.6%
2 to 11	9	1.9%
12 to 17	13	2.7%
18 to 44	101	21.2%
45 to 64	187	39.3%
65 to 74	60	12.6%
75 and over	21	4.4%
Age not given	82	17.2%

Sex of the patient in the reports that name Gammaplex
Sex	Reports	Share
Female	320	67.2%
Male	135	28.4%
Unknown or not given	21	4.4%

Type of reporter in the reports that name Gammaplex
Reporter	Reports	Share
Physician	22	4.6%
Pharmacist	215	45.2%
Other health professional	155	32.6%
Lawyer	0	0%
Consumer or non-health professional	55	11.6%
Not given	29	6.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 88.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Gammaplex record
Indication as recorded (MedDRA)	Reports	Share
Chronic inflammatory demyelinating polyradiculoneuropathy	56	11.8%
Immunodeficiency common variable	40	8.4%
Hypogammaglobulinaemia	27	5.7%
Myasthenia gravis	23	4.8%
Polyneuropathy	12	2.5%
Dermatomyositis	6	1.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 476 reports.

Pages near this one

Human immunoglobulin g same ingredient
Hizentra same ingredient
Privigen same ingredient
GAMMAGARD Liquid same class
Gamunex-C same class
Flebogamma same class
Cytogam same class
Gammagard S/D next in the A to Z list
Gamunex next in the A to Z list
Gamunex C next in the A to Z list
Gammagard next in the A to Z list
Galvus Met next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for GammaplexThe 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. Gammaplex: adverse event reports that FDA received. https://reportedreactions.com/drug/gammaplex/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Gammaplex as a suspect or interacting product. The 95 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 Gammaplex 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 Gammaplex?

No. It is a count of what people reported to FDA: 476 reports from April 2011 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?

Pharmacist (45.2%), other health professional (32.6%) and consumer or non-health professional (11.6%). 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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