Pharmacologic class (EPC) · 11 drug pages

Human immunoglobulin G: adverse event reports filed with FDA

70,639 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

70,639
reports across the class: 0.3% of all reports; 7,247
reports, 12 months to June 2026: 7,748 in the 12 months before; 65.3%
marked serious by the reporter: 57.4% across all reports; 11
drugs with a page: brand and generic names counted separately

Human immunoglobulin G is a pharmacologic class (an FDA Established Pharmacologic Class) with 11 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 70,639 adverse event reports received by FDA, 0.3% of the database, from January 2004 to June 2026.

7,247 reports arrived in the 12 months to June 2026, close to the 7,748 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 65.3% of the class's reports are marked serious, 7.4% record death among the outcomes and 24.9% record hospitalisation, as reported.

Across the class the reactions recorded most often are headache (11.3%), off label use (8.7%) and fatigue (8%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
HizentraHuman immunoglobulin g	brand	22,916	1,422	45.8%	Headache
Human immunoglobulin g	generic	17,139	2,943	94.5%	Off label use
PrivigenHuman immunoglobulin g	brand	8,718	579	69.7%	Headache
GAMMAGARD LiquidImmune globulin infusion (human)	brand	8,350	253	62.7%	Headache
CuvitruImmune globulin subcutaneous (human)	brand	4,002	194	48.7%	Sinusitis
Gamunex-CImmune globulin	brand	3,622	959	38.7%	Urticaria
Immune globulin	generic	2,625	525	95.6%	Drug ineffective
Octagam Immune Globulin (Human)Immune globulin	brand	1,121	85	78.7%	Urticaria
XembifyImmune globulin subcutaneous, human-klhw	brand	817	245	44.1%	Infusion site erythema
Immune globulin intravenous (human)	generic	670	2	93.9%	Neutropenia
RhophylacHuman rho(d) immune globulin	brand	659	40	56.1%	No adverse event

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Headachehead pain11.3%8,005
Off label useused for a purpose or in a way not on the label8.7%6,179
Fatiguetiredness8%5,674
Sinusitissinus infection6.5%4,618
Nauseafeeling sick6.3%4,484
Drug ineffectivethe medicine did not work as expected6.1%4,286
Pyrexiafever6%4,241
Pruritusitching5%3,538
Dyspnoeashortness of breath5%3,508
Pneumonialung infection4.9%3,457
Malaisegeneral feeling of being unwell4.7%3,303
Painpain, site not specified4.6%3,229
No adverse eventno adverse event was reported4.4%3,143
Rashskin rash4.1%2,876
Chillschills or shivering4%2,860
Covid-19COVID-19 infection4%2,853
Urticariahives3.8%2,688
Vomitingbeing sick3.8%2,663
Product dose omission issuea dose was missed3.7%2,579
Infectionan infection, type not specified3.6%2,570
Infusion related reactiona reaction during or soon after an infusion3.5%2,507
Deaththe patient died; cause not stated by this term3.4%2,399
Diarrhoealoose or frequent stools3.2%2,292
Coughcough3.1%2,199
Infusion site pain3%2,130

Solid bar: share of all class reports. Hollow bar: the median share across the 11 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death7.4%5,262

Life-threatening3.3%2,332

Hospitalisation (initial or prolonged)24.9%17,560

Disability0.8%600

Congenital anomaly0.2%133

Other serious49.1%34,679

Not serious34.7%24,543

Patient age

Under 20.9%665

2 to 114.1%2,870

12 to 172.5%1,731

18 to 4412.6%8,874

45 to 6419.8%13,952

65 to 7411.2%7,910

75 and over6.6%4,676

Age not given42.4%29,961

Who reported

Physician13.1%9,279

Pharmacist11.6%8,219

Other health professional41.7%29,491

Lawyer0%8

Consumer or non-health professional31.9%22,544

Not given1.6%1,098

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Human immunoglobulin G reports

Which drugs are in the Human immunoglobulin G class on this site?

Hizentra, Human immunoglobulin g, Privigen, GAMMAGARD Liquid, Cuvitru and Gamunex-C and 5 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

70,639 reports through June 2026, 7,247 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

headache (11.3%), off label use (8.7%), fatigue (8%), sinusitis (6.5%) and nausea (6.3%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.