HUMAN RHO IMMUNE GLOBULIN: 1,207 Adverse Event Reports & Safety Profile
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1,207
Total FAERS Reports
24 (2.0%)
Deaths Reported
239
Hospitalizations
1,207
As Primary/Secondary Suspect
43
Life-Threatening
32
Disabilities
Kedrion Biopharma Inc
Manufacturer
Drug Class: Endogenous Antigen Neutralization [MoA] · Manufacturer: Kedrion Biopharma Inc ·
First Report: 19930430 · Latest Report: 20250920
What Are the Most Common HUMAN RHO IMMUNE GLOBULIN Side Effects?
#1 Most Reported
No adverse event
238 reports (19.7%)
#2 Most Reported
Drug ineffective
201 reports (16.7%)
#3 Most Reported
Device issue
167 reports (13.8%)
All HUMAN RHO IMMUNE GLOBULIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| No adverse event | 238 | 19.7% | 0 | 2 |
| Drug ineffective | 201 | 16.7% | 6 | 77 |
| Device issue | 167 | 13.8% | 0 | 1 |
| Syringe issue | 154 | 12.8% | 0 | 1 |
| Nausea | 111 | 9.2% | 7 | 19 |
| Treatment failure | 110 | 9.1% | 6 | 88 |
| Arthralgia | 109 | 9.0% | 6 | 74 |
| Therapy non-responder | 107 | 8.9% | 7 | 77 |
| Pain in extremity | 104 | 8.6% | 6 | 76 |
| Therapeutic product effect decreased | 104 | 8.6% | 5 | 31 |
| Joint swelling | 100 | 8.3% | 6 | 75 |
| Infection | 98 | 8.1% | 6 | 74 |
| Haemolysis | 97 | 8.0% | 1 | 6 |
| Hepatotoxicity | 96 | 8.0% | 6 | 72 |
| Musculoskeletal stiffness | 96 | 8.0% | 6 | 73 |
| Condition aggravated | 94 | 7.8% | 7 | 74 |
| Gastrointestinal toxicity | 93 | 7.7% | 6 | 72 |
| Musculoskeletal pain | 93 | 7.7% | 6 | 72 |
| Neoplasm malignant | 93 | 7.7% | 6 | 72 |
| Joint injury | 91 | 7.5% | 6 | 71 |
Who Reports HUMAN RHO IMMUNE GLOBULIN Side Effects? Age & Gender Data
Gender: 85.3% female, 14.7% male. Average age: 32.5 years. Most reports from: US. View detailed demographics →
Is HUMAN RHO IMMUNE GLOBULIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 2 | 0 | 1 |
| 2004 | 2 | 0 | 2 |
| 2005 | 3 | 0 | 1 |
| 2006 | 3 | 0 | 0 |
| 2007 | 2 | 0 | 0 |
| 2008 | 5 | 2 | 3 |
| 2009 | 6 | 0 | 0 |
| 2010 | 1 | 0 | 0 |
| 2011 | 3 | 0 | 1 |
| 2012 | 1 | 0 | 0 |
| 2013 | 15 | 1 | 3 |
| 2014 | 32 | 2 | 8 |
| 2015 | 52 | 1 | 9 |
| 2016 | 37 | 0 | 8 |
| 2017 | 39 | 2 | 8 |
| 2018 | 36 | 1 | 4 |
| 2019 | 50 | 1 | 10 |
| 2020 | 47 | 0 | 10 |
| 2021 | 65 | 0 | 20 |
| 2022 | 17 | 0 | 4 |
| 2023 | 11 | 1 | 2 |
| 2024 | 29 | 0 | 4 |
| 2025 | 9 | 0 | 4 |
What Is HUMAN RHO IMMUNE GLOBULIN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 385 |
| Prophylaxis against rh isoimmunisation | 138 |
| Immune thrombocytopenic purpura | 50 |
| Rhesus antigen negative | 44 |
| Rhesus incompatibility | 43 |
| Immune thrombocytopenia | 36 |
| Prophylaxis | 31 |
| Alloimmunisation | 26 |
| Foetal-maternal haemorrhage | 19 |
| Pregnancy | 17 |
HUMAN RHO IMMUNE GLOBULIN vs Alternatives: Which Is Safer?
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HUMAN RHO IMMUNE GLOBULIN vs HYALURONIC ACID\LIDOCAINE
HUMAN RHO IMMUNE GLOBULIN vs HYALURONIDASE
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HUMAN RHO IMMUNE GLOBULIN vs HYDRALAZINE
Official FDA Label for HUMAN RHO IMMUNE GLOBULIN
Official prescribing information from the FDA-approved drug label.