Human immunoglobulin g: adverse event reports filed with FDA

17,139

reports as suspect product

0.1% of all reports · about 961 a year

2,943

reports, 12 months to June 2026

3,442 in the 12 months before

94.5%

marked serious by the reporter

65.3% across the class

13.7%

record death among outcomes, as reported

2,350 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Human immunoglobulin g reports recording the termmedian drug in human immunoglobulin g

1. Off label useused for a purpose or in a way not on the label20.3%3,478
2. Fatiguetiredness13.3%2,271
3. Headachehead pain12.7%2,180
4. Drug ineffectivethe medicine did not work as expected12.7%2,174
5. Covid-19COVID-19 infection11.9%2,040
6. Sinusitissinus infection10.9%1,863
7. Product dose omission issuea dose was missed10.5%1,796
8. Pneumonialung infection10%1,722
9. Inappropriate schedule of product administrationthe product was taken at the wrong times9%1,545
10. Nauseafeeling sick8.6%1,477
11. Malaisegeneral feeling of being unwell8.4%1,445
12. Pyrexiafever7.8%1,331
13. Falla fall7.5%1,289
14. Painpain, site not specified7%1,198
15. Illness6.9%1,190
16. Infectionan infection, type not specified6.4%1,102
17. Dyspnoeashortness of breath6.4%1,094
18. Urinary tract infectionbladder or urinary infection6.3%1,085
19. Nasopharyngitisa cold6.3%1,074
20. Coughcough5.8%993
21. Diarrhoealoose or frequent stools5.7%978
22. Vomitingbeing sick5.3%911
23. Deaththe patient died; cause not stated by this term5.2%891
24. Dizzinesslight-headedness or unsteadiness5.2%888
25. Insurance issue5.2%888
26. Arthralgiajoint pain5.1%869
27. Blood pressure increaseda raised blood pressure reading5%851
28. Chillschills or shivering4.8%817
29. Weight decreasedweight loss4.7%813
30. Product use issuea problem in how the product was used4.7%811

Top 30 of 2,878 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 11 drugs in the human immunoglobulin g class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 70,639 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 48.8% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 17,139 reports.

Drugs most often listed in the same reports

Other products listed in reports where Human immunoglobulin g is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the human immunoglobulin g class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Human immunoglobulin g as a suspect or interacting product; reports listing it only as a concomitant medication (3,219) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.