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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

UBLITUXIMAB-XIIY: 900 Adverse Event Reports & Safety Profile

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900
Total FAERS Reports
9 (1.0%)
Deaths Reported
66
Hospitalizations
900
As Primary/Secondary Suspect
2
Life-Threatening
2
Disabilities
Prescription
Status

FDA Application: 761238 ·

First Report: 20200101 · Latest Report: 20250828

What Are the Most Common UBLITUXIMAB-XIIY Side Effects?

#1 Most Reported
Infusion related reaction
481 reports (53.4%)
#2 Most Reported
Fatigue
48 reports (5.3%)
#3 Most Reported
Headache
34 reports (3.8%)

All UBLITUXIMAB-XIIY Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Infusion related reaction 481 53.4% 0 18
Fatigue 48 5.3% 0 2
Headache 34 3.8% 0 3
Malaise 22 2.4% 0 0
Inappropriate schedule of product administration 21 2.3% 0 0
Product dose omission issue 19 2.1% 0 1
Asthenia 18 2.0% 1 3
Drug ineffective 18 2.0% 1 0
Nausea 18 2.0% 1 2
Dizziness 17 1.9% 1 1
Covid-19 16 1.8% 0 1
Off label use 16 1.8% 0 1
Pyrexia 16 1.8% 0 1
Urinary tract infection 16 1.8% 0 3
Back pain 15 1.7% 0 0
Diarrhoea 13 1.4% 2 3
Maternal exposure during pregnancy 12 1.3% 0 1
Chills 11 1.2% 0 1
Fall 11 1.2% 2 4
Feeling abnormal 11 1.2% 0 0

Who Reports UBLITUXIMAB-XIIY Side Effects? Age & Gender Data

Gender: 74.8% female, 25.2% male. Average age: 44.8 years. Most reports from: US. View detailed demographics →

Is UBLITUXIMAB-XIIY Getting Safer? Reports by Year

YearReportsDeathsHosp.
2020 1 0 1
2023 375 3 17
2024 212 1 23
2025 115 2 18

View full timeline →

What Is UBLITUXIMAB-XIIY Used For?

IndicationReports
Multiple sclerosis 661
Product used for unknown indication 173
Relapsing multiple sclerosis 19
Relapsing-remitting multiple sclerosis 18

UBLITUXIMAB-XIIY vs Alternatives: Which Is Safer?

UBLITUXIMAB-XIIY vs UBROGEPANT UBLITUXIMAB-XIIY vs ULIPRISTAL UBLITUXIMAB-XIIY vs UMBRALISIB UBLITUXIMAB-XIIY vs UMECLIDINIUM UBLITUXIMAB-XIIY vs UMECLIDINIUM\VILANTEROL TRIFENATATE UBLITUXIMAB-XIIY vs UMIFENOVIR UBLITUXIMAB-XIIY vs UNSPECIFIED INGREDIENT UBLITUXIMAB-XIIY vs UPADACITINIB UBLITUXIMAB-XIIY vs URAPIDIL UBLITUXIMAB-XIIY vs UREA

Official FDA Label for UBLITUXIMAB-XIIY

Official prescribing information from the FDA-approved drug label.