IBALIZUMAB-UIYK: 418 Adverse Event Reports & Safety Profile
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418
Total FAERS Reports
31 (7.4%)
Deaths Reported
94
Hospitalizations
418
As Primary/Secondary Suspect
3
Life-Threatening
2
Disabilities
Prescription
Status
FDA Application: 761065 ·
First Report: 2018 · Latest Report: 20250306
What Are the Most Common IBALIZUMAB-UIYK Side Effects?
#1 Most Reported
Rash
40 reports (9.6%)
#2 Most Reported
Viral load increased
37 reports (8.9%)
#3 Most Reported
Product dose omission issue
37 reports (8.9%)
All IBALIZUMAB-UIYK Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Rash | 40 | 9.6% | 1 | 3 |
| Product dose omission issue | 37 | 8.9% | 1 | 13 |
| Viral load increased | 37 | 8.9% | 0 | 4 |
| Drug ineffective | 31 | 7.4% | 0 | 2 |
| Hospitalisation | 30 | 7.2% | 3 | 30 |
| Diarrhoea | 28 | 6.7% | 1 | 3 |
| Fatigue | 28 | 6.7% | 0 | 3 |
| Pruritus | 24 | 5.7% | 0 | 3 |
| Nausea | 22 | 5.3% | 2 | 3 |
| Death | 21 | 5.0% | 21 | 8 |
| Dizziness | 18 | 4.3% | 1 | 6 |
| Dyspnoea | 16 | 3.8% | 0 | 9 |
| Headache | 16 | 3.8% | 0 | 3 |
| Incorrect dose administered | 16 | 3.8% | 0 | 0 |
| Pyrexia | 16 | 3.8% | 0 | 5 |
| Off label use | 14 | 3.4% | 1 | 2 |
| Pain | 12 | 2.9% | 0 | 3 |
| Vomiting | 12 | 2.9% | 0 | 2 |
| Pneumonia | 11 | 2.6% | 0 | 9 |
| Product dose omission | 11 | 2.6% | 2 | 6 |
Who Reports IBALIZUMAB-UIYK Side Effects? Age & Gender Data
Gender: 22.8% female, 77.2% male. Average age: 56.0 years. Most reports from: US. View detailed demographics →
Is IBALIZUMAB-UIYK Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2018 | 27 | 4 | 11 |
| 2019 | 22 | 2 | 8 |
| 2020 | 37 | 4 | 12 |
| 2021 | 26 | 1 | 3 |
| 2022 | 38 | 4 | 9 |
| 2023 | 35 | 1 | 4 |
| 2024 | 26 | 3 | 7 |
| 2025 | 6 | 1 | 3 |
What Is IBALIZUMAB-UIYK Used For?
| Indication | Reports |
|---|---|
| Hiv infection | 227 |
| Product used for unknown indication | 177 |
| Antiretroviral therapy | 12 |
| Acquired immunodeficiency syndrome | 7 |
IBALIZUMAB-UIYK vs Alternatives: Which Is Safer?
IBALIZUMAB-UIYK vs IBANDRONATE
IBALIZUMAB-UIYK vs IBANDRONIC ACID
IBALIZUMAB-UIYK vs IBERDOMIDE
IBALIZUMAB-UIYK vs IBREXAFUNGERP
IBALIZUMAB-UIYK vs IBRITUMOMAB TIUXETAN
IBALIZUMAB-UIYK vs IBRUTINIB
IBALIZUMAB-UIYK vs IBUPROFEN
IBALIZUMAB-UIYK vs IBUPROFEN LYSINE
IBALIZUMAB-UIYK vs IBUPROFEN UNKNOWN PRODUCT
IBALIZUMAB-UIYK vs IBUPROFEN\IBUPROFEN
Official FDA Label for IBALIZUMAB-UIYK
Official prescribing information from the FDA-approved drug label.