What the label lists and what reports show
Human immunoglobulin g side effects
Human immunoglobulin g's FDA label: “The most common adverse reactions observed in ≥ 5% of patients were headache, fatigue, nausea, infusion-related reaction, Coombs direct test positive, sinusitis, dizziness and diarrhea.” FAERS holds 20,363 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (2,474 reports).
- No generic listed
- Boxed warning
Check it at the source: the human immunoglobulin g FDA label on DailyMed (effective February 2, 2026); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions observed in ≥ 5% of patients were headache, fatigue, nausea, infusion-related reaction, Coombs direct test positive, sinusitis, dizziness and diarrhea.
Table 2: Adverse Reactions Adverse reactions were defined as adverse events occurring during or within 72 hours of infusion or any causally related event occurring within the study period. Occurring in ≥ 5% of Patients
| Adverse Reaction | By Patients n (%) [n = 47] | By Infusions n (%) [n = 643] |
|---|---|---|
| Headache | 14 (30) | 26 (4) |
| Fatigue | 7 (15) | 10 (2) |
| Nausea | 6 (13) | 6 (<1) |
| Infusion-related Reaction | 5 (11) | 7 (1) |
| Coombs Direct Test Positive | 5 (11) | 8 (1) |
| Sinusitis | 3 (6) | 3 (<1) |
| Dizziness | 3 (6) | 3 (<1) |
| Diarrhea | 3 (6) | 4 (<1) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most common adverse reactions observed in ≥ 5% of patients were headache, fatigue, nausea, infusion-related reaction, Coombs direct test positive, sinusitis, dizziness and diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma Inc. at 1-855-3KDRION (1-855-353-7466) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one drug cannot be directly compared to rates in other clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data described in this section reflects exposure to QIVIGY in one clinical study. A total of 47 patients with PI received intravenous infusion of QIVIGY at a dose range of 266 to 826 mg/kg every 3 or 4 weeks for up to 12 months [see Clinical Studies (14) ]. A total of 643 infusions of QIVIGY were administered, 136 in the every 3-week schedule and 507 in the 4-week schedule. During the study, 4 out of 47 (9%) patients received premedication. The most common product-related adverse events observed in ≥ 5% of clinical study patients with PI were headache, infusion-related reaction, Coombs direct test positive, fatigue, and nausea. Table 2 lists the most common adverse reactions reported in ≥5% of patients. …
Source: FDA drug label, Kedrion S.p.A., effective February 2, 2026 (SPL set 6f1933e0-240f-48f4-b246-8a30e63a4160), via openFDA; the full label on DailyMed
What do FAERS reports show?
20,363 reports list human immunoglobulin g among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,729 are coded as a death and 7,768 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Human immunoglobulin g: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions