Immune globulin intravenous (human): adverse event reports filed with FDA

670

reports as suspect product

0% of all reports · about 30 a year

2

reports, 12 months to June 2026

0 in the 12 months before

93.9%

marked serious by the reporter

65.3% across the class

10%

record death among outcomes, as reported

67 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 Immune globulin intravenous (human) reports recording the termmedian drug in human immunoglobulin g

1. Neutropenialow neutrophils, a type of white blood cell13.1%88
2. Pyrexiafever6.4%43
3. Drug exposure during pregnancythe medicine was taken during pregnancy5.4%36
4. Infusion related reactiona reaction during or soon after an infusion4.2%28
5. Drug ineffectivethe medicine did not work as expected4%27
6. Headachehead pain3.9%26
7. Nauseafeeling sick3.7%25
8. Maternal exposure during pregnancythe mother took the medicine during pregnancy3.6%24
9. Chillschills or shivering3.4%23
10. Vomitingbeing sick3.1%21
11. Renal failure acute3%20
12. Cerebrovascular accidentstroke2.4%16
13. Hypotensionlow blood pressure2.2%15
14. Pulmonary embolisma blood clot in the lung2.2%15
15. Anaphylactoid reaction2.1%14
16. Abortion spontaneousmiscarriage1.9%13
17. Haemorrhage intracranial1.9%13
18. Meningitis aseptic1.9%13
19. Respiratory failurethe lungs could not supply enough oxygen1.9%13
20. Drug intolerancethe medicine was not tolerated1.8%12
21. Renal failurekidney failure1.8%12
22. Thrombocytopenialow platelets1.8%12
23. Anaphylactic reactiona severe, sudden allergic reaction1.6%11
24. Haemoglobin decreasedlow haemoglobin1.6%11
25. Haemolytic anaemia1.6%11
26. Pneumonialung infection1.6%11
27. Rashskin rash1.6%11
28. Astheniaweakness or lack of energy1.5%10
29. Cerebral infarction1.5%10
30. Convulsion1.5%10

Top 30 of 245 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. 35.2% 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 670 reports.

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 Immune globulin intravenous (human) as a suspect or interacting product; reports listing it only as a concomitant medication (855) 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.