Immunoglobulins adverse event reports that FDA received

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

Name type: Product name as reported
Also reported as: Immunoglobulins Nos

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 May 2004 to September 2021, FDA received 410 adverse event reports that name Immunoglobulins. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 1,209 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 0 reports in the 12 months to June 2026 and 0 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Reports from other health professionals were 62.2% of the reports that name Immunoglobulins 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 Immunoglobulins 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.

FDA received no report that names Immunoglobulins in April to June 2026, in January to March 2026 or in April to June 2025.

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 54 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 310 of the 410 reports (75.6%).

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 the first 50 of 54 terms.

Reaction terms in the reports that name Immunoglobulins, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 410 reports
Drug ineffectivethe medicine did not work as expected	87	21.2%
Off label useused for a purpose or in a way not on the label	80	19.5%
Product use in unapproved indicationused for a purpose not on the label	38	9.3%
Condition aggravatedthe condition being treated got worse	23	5.6%
Septic shockshock arising from infection	14	3.4%
Adrenal insufficiencythe adrenal glands produce too little hormone	13	3.2%
Acute graft versus host disease	12	2.9%
Coma	12	2.9%
Cytomegalovirus infection reactivation	12	2.9%
Psoriasispsoriasis, a skin condition	12	2.9%
Gastrooesophageal reflux diseaseacid reflux	11	2.7%
Nauseafeeling sick	11	2.7%
Pneumonia aspirationlung infection from breathing in material	11	2.7%
Somnolencedrowsiness	11	2.7%
Vomitingbeing sick	11	2.7%
Diarrhoealoose or frequent stools	10	2.4%
Drug ineffective for unapproved indication	10	2.4%
Graft versus host disease	10	2.4%
Body height below normal	9	2.2%
Drug intolerancethe medicine was not tolerated	9	2.2%
Exposure during pregnancythe medicine was taken during pregnancy	9	2.2%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	9	2.2%
Acute kidney injurysudden loss of kidney function	8	2%
Arthralgiajoint pain	8	2%
Arthritis	8	2%
Chronic graft versus host disease	8	2%
Human antichimeric antibody positive	8	2%
Juvenile idiopathic arthritis	8	2%
Premature babya baby born early	8	2%
Premature delivery	8	2%
Respiratory failurethe lungs could not supply enough oxygen	8	2%
C-reactive protein increased	7	1.7%
Obesity	7	1.7%
Pyrexiafever	7	1.7%
Synovitis	7	1.7%
Thrombocytopenialow platelets	7	1.7%
Antibody test positive	6	1.5%
Interstitial lung diseasescarring or inflammation of lung tissue	6	1.5%
Neutropenialow neutrophils, a type of white blood cell	6	1.5%
Normal newborn	6	1.5%
Polyarthritis	6	1.5%
Product use issuea problem in how the product was used	6	1.5%
Red blood cell sedimentation rate increased	6	1.5%
Adrenal suppression	5	1.2%
BK virus infection	5	1.2%
Bone density decreased	5	1.2%
Fatiguetiredness	5	1.2%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	5	1.2%
Intentional product use issuedeliberate use not as intended	5	1.2%
Loss of personal independence in daily activities	5	1.2%

Download all 54 terms of Immunoglobulins (CSV)

The counts add to more than 410 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.

Outcomes by year

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

Outcomes in the reports that name Immunoglobulins, 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	3	3	3	1	1	0	1	0
2005	5	5	0	0	4	1	3	0
2006	4	3	1	1	1	1	0	1
2007	6	6	1	0	2	0	5	0
2008	6	6	2	0	2	0	2	0
2009	6	6	1	1	1	0	5	0
2010	3	3	1	0	1	0	1	0
2011	7	6	0	0	1	0	6	1
2012	7	7	2	0	2	0	6	0
2013	10	10	4	0	3	0	6	0
2014	23	23	5	0	7	0	21	0
2015	7	7	3	0	5	0	6	0
2016	11	11	2	3	2	2	8	0
2017	25	25	3	8	3	0	24	0
2018	30	29	3	2	12	0	26	1
2019	34	33	4	1	17	0	25	1
2020	122	117	20	7	48	1	95	5
2021	101	97	8	14	42	3	76	4
2022	0	0	0	0	0	0	0	0
2023	0	0	0	0	0	0	0	0
2024	0	0	0	0	0	0	0	0
2025	0	0	0	0	0	0	0	0
2026	0	0	0	0	0	0	0	0

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 Immunoglobulins, by the year in which FDA received them

Show the figures of the chart as a table

Reports that name Immunoglobulins, by the year in which FDA received them
Year	Reports
2004	2
2005	6
2006	4
2007	6
2008	5
2009	7
2010	1
2011	10
2012	8
2013	10
2014	25
2015	5
2016	14
2017	25
2018	35
2019	35
2020	121
2021	91

Reports that name Immunoglobulins, 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 Immunoglobulins
Age	Reports	Share
Under 2	21	5.1%
2 to 11	40	9.8%
12 to 17	23	5.6%
18 to 44	90	22%
45 to 64	80	19.5%
65 to 74	38	9.3%
75 and over	14	3.4%
Age not given	104	25.4%

Sex of the patient in the reports that name Immunoglobulins
Sex	Reports	Share
Female	177	43.2%
Male	120	29.3%
Unknown or not given	113	27.6%

Type of reporter in the reports that name Immunoglobulins
Reporter	Reports	Share
Physician	96	23.4%
Pharmacist	6	1.5%
Other health professional	255	62.2%
Lawyer	0	0%
Consumer or non-health professional	28	6.8%
Not given	25	6.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 27.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Immunoglobulins record
Indication as recorded (MedDRA)	Reports	Share
Covid-19	27	6.6%
Antiviral prophylaxis	14	3.4%
Immunosuppressant drug therapy	9	2.2%
Immunosuppression	9	2.2%
Dermatomyositis	7	1.7%
Myasthenia gravis	7	1.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 410 reports.

Drugs in the same reports

Other drugs that the reports of Immunoglobulins name, in any role, in order of name
Drug	Reports that name the two
Azathioprine	16
Ciclosporin	19
Cyclophosphamide	48
Hydroxychloroquine	39
Methylprednisolone	104
Mycophenolate mofetil	50
Prednisolone	23
Prednisone	74
Rituximab	43
Tacrolimus	51

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

Immunoglobulin I V next in the A to Z list
Imnovid next in the A to Z list
Immunoglobulin Human Normal next in the A to Z list
Imodium next in the A to Z list
Immunoglobulin next in the A to Z list
Imodium A D next in the A to Z list
Immune globulin intravenous (human) next in the A to Z list
Imodium A-D next in the A to Z list
Immune globulin (human) next in the A to Z list
Imodium Multi Symptom Relief next in the A to Z list
Immucyst next in the A to Z list
Imodium Multi-Symptom Relief next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for ImmunoglobulinsThe 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. Immunoglobulins: adverse event reports that FDA received. https://reportedreactions.com/drug/immunoglobulins/ 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 Immunoglobulins as a suspect or interacting product. The 1,209 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 Immunoglobulins 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 Immunoglobulins?

No. It is a count of what people reported to FDA: 410 reports from May 2004 to September 2021. 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 (62.2%), physician (23.4%) and consumer or non-health professional (6.8%). 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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