HUMAN IMMUNOGLOBULIN G

N/A

Manufactured by ADMA Biologics, Inc.

73,013 FDA adverse event reports analyzed

Last updated: 2026-04-14

About HUMAN IMMUNOGLOBULIN G

HUMAN IMMUNOGLOBULIN G is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ADMA Biologics, Inc.. The most commonly reported adverse reactions for HUMAN IMMUNOGLOBULIN G include OFF LABEL USE, FATIGUE, DRUG INEFFECTIVE, HEADACHE, COVID-19. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HUMAN IMMUNOGLOBULIN G.

Top Adverse Reactions

OFF LABEL USE4,121 reports
FATIGUE2,343 reports
DRUG INEFFECTIVE2,290 reports
HEADACHE2,154 reports
COVID 192,125 reports
SINUSITIS1,801 reports
PRODUCT DOSE OMISSION ISSUE1,753 reports
PNEUMONIA1,749 reports
NAUSEA1,524 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION1,498 reports
MALAISE1,444 reports
PYREXIA1,374 reports
FALL1,285 reports
PAIN1,240 reports
ILLNESS1,171 reports
DYSPNOEA1,142 reports
INFECTION1,120 reports
DIARRHOEA1,085 reports
URINARY TRACT INFECTION1,062 reports
NASOPHARYNGITIS1,056 reports
COUGH1,034 reports
VOMITING950 reports
DIZZINESS925 reports
ARTHRALGIA897 reports
ASTHENIA891 reports
DEATH890 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION860 reports
BLOOD PRESSURE INCREASED856 reports
INSURANCE ISSUE835 reports
WEIGHT DECREASED832 reports
PRODUCT USE ISSUE795 reports
INFUSION RELATED REACTION787 reports
CHILLS766 reports
BRONCHITIS760 reports
PRODUCT USE IN UNAPPROVED INDICATION736 reports
CONDITION AGGRAVATED714 reports
INFLUENZA709 reports
PRURITUS709 reports
INFUSION SITE PAIN667 reports
UPPER RESPIRATORY TRACT INFECTION656 reports
SEPSIS637 reports
BACK PAIN624 reports
RASH610 reports
ABDOMINAL PAIN580 reports
PAIN IN EXTREMITY554 reports
INFUSION SITE SWELLING520 reports
DRUG HYPERSENSITIVITY513 reports
WEIGHT INCREASED503 reports
ASTHMA502 reports
MIGRAINE494 reports
RESPIRATORY TRACT INFECTION484 reports
INFUSION SITE ERYTHEMA477 reports
SOMNOLENCE471 reports
SEASONAL ALLERGY461 reports
EAR INFECTION460 reports
TACHYCARDIA451 reports
FEELING ABNORMAL450 reports
ARTHRITIS445 reports
MYALGIA445 reports
MULTIPLE ALLERGIES430 reports
VIRAL INFECTION423 reports
THERAPY NON RESPONDER421 reports
CONTUSION416 reports
GASTROINTESTINAL DISORDER411 reports
HYPERTENSION409 reports
INSOMNIA397 reports
DECREASED APPETITE380 reports
ABDOMINAL PAIN UPPER376 reports
OROPHARYNGEAL PAIN362 reports
POOR VENOUS ACCESS357 reports
DRUG INTOLERANCE352 reports
INTENTIONAL PRODUCT USE ISSUE351 reports
GASTROENTERITIS VIRAL350 reports
URTICARIA350 reports
HYPERSENSITIVITY342 reports
PERIPHERAL SWELLING338 reports
INCORRECT DRUG ADMINISTRATION RATE337 reports
INCORRECT DOSE ADMINISTERED333 reports
ANXIETY332 reports
HYPOTENSION327 reports
ABDOMINAL DISCOMFORT325 reports
ERYTHEMA322 reports
INFUSION SITE BRUISING322 reports
INFUSION SITE PRURITUS320 reports
INFUSION SITE HAEMORRHAGE313 reports
MUSCULAR WEAKNESS312 reports
CHEST PAIN309 reports
LOSS OF CONSCIOUSNESS305 reports
CHEST DISCOMFORT303 reports
LOWER RESPIRATORY TRACT INFECTION295 reports
SYNCOPE294 reports
TREATMENT FAILURE289 reports
SWELLING286 reports
GAIT DISTURBANCE282 reports
ANAEMIA281 reports
DERMATITIS CONTACT280 reports
RHEUMATOID ARTHRITIS276 reports
EYE PAIN273 reports
SEPTIC SHOCK273 reports
VISION BLURRED272 reports

Report Outcomes

Out of 18,464 classified reports for HUMAN IMMUNOGLOBULIN G:

Serious 92.0%Non-Serious 8.0%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female10,496 (62.6%)
Male6,272 (37.4%)
Unknown6 (0.0%)

Reports by Age

Age 65295 reports
Age 67294 reports
Age 64289 reports
Age 68269 reports
Age 62268 reports
Age 73265 reports
Age 72262 reports
Age 66254 reports
Age 63251 reports
Age 61250 reports
Age 70250 reports
Age 56243 reports
Age 60241 reports
Age 69230 reports
Age 54227 reports
Age 71225 reports
Age 57214 reports
Age 58210 reports
Age 59203 reports
Age 75199 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with HUMAN IMMUNOGLOBULIN G?

This profile reflects 73,013 FDA FAERS reports that mention HUMAN IMMUNOGLOBULIN G. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for HUMAN IMMUNOGLOBULIN G?

Frequently reported terms in FAERS include OFF LABEL USE, FATIGUE, DRUG INEFFECTIVE, HEADACHE, COVID-19, SINUSITIS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures HUMAN IMMUNOGLOBULIN G?

Labeling and FAERS entries often list ADMA Biologics, Inc. in connection with HUMAN IMMUNOGLOBULIN G. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.