Privigen: adverse event reports filed with FDA

8,718

reports as suspect product

0% of all reports · about 480 a year

579

reports, 12 months to June 2026

633 in the 12 months before

69.7%

marked serious by the reporter

65.3% across the class

5.6%

record death among outcomes, as reported

491 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 Privigen reports recording the termmedian drug in human immunoglobulin g

1. Headachehead pain14.2%1,241
2. Off label useused for a purpose or in a way not on the label9.8%856
3. Chillschills or shivering9.5%832
4. Pyrexiafever9.3%807
5. No adverse eventno adverse event was reported7.5%651
6. Nauseafeeling sick7.3%635
7. Dyspnoeashortness of breath7%611
8. Rashskin rash6.5%569
9. Pruritusitching6.4%555
10. Urticariahives5.8%505
11. Vomitingbeing sick5.1%441
12. Fatiguetiredness4.5%389
13. Infusion related reactiona reaction during or soon after an infusion3.9%341
14. Hypertensionhigh blood pressure3.6%311
15. Tachycardiafast heart rate3.5%308
16. Painpain, site not specified3.4%300
17. Malaisegeneral feeling of being unwell3.3%286
18. Blood pressure increaseda raised blood pressure reading3.2%282
19. Erythemaskin redness2.9%252
20. Hypersensitivityan allergic-type reaction2.8%247
21. Product use in unapproved indicationused for a purpose not on the label2.8%244
22. Dizzinesslight-headedness or unsteadiness2.8%243
23. Hypotensionlow blood pressure2.8%241
24. Drug ineffectivethe medicine did not work as expected2.7%235
25. Sinusitissinus infection2.7%233
26. Anaphylactic reactiona severe, sudden allergic reaction2.6%228
27. Back painback pain2.6%226
28. Meningitis aseptic2.5%216
29. Coughcough2.4%212
30. Oxygen saturation decreased2.4%209

Top 30 of 1,119 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. 53.8% 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 8,718 reports.

Drugs most often listed in the same reports

Other products listed in reports where Privigen 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 Privigen as a suspect or interacting product; reports listing it only as a concomitant medication (1,480) 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.