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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.

TOSITUMOMAB I-131: 38 Adverse Event Reports & Safety Profile

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38
Total FAERS Reports
29 (76.3%)
Deaths Reported
3
Hospitalizations
38
As Primary/Secondary Suspect
2
Life-Threatening

First Report: 20171017 · Latest Report: 20220805

What Are the Most Common TOSITUMOMAB I-131 Side Effects?

#1 Most Reported
Second primary malignancy
22 reports (57.9%)
#2 Most Reported
Myelodysplastic syndrome
6 reports (15.8%)
#3 Most Reported
Neoplasm malignant
5 reports (13.2%)

All TOSITUMOMAB I-131 Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Second primary malignancy 22 57.9% 21 0
Myelodysplastic syndrome 6 15.8% 0 2
Neoplasm malignant 5 13.2% 5 0

Who Reports TOSITUMOMAB I-131 Side Effects? Age & Gender Data

Gender: 11.1% female, 88.9% male. Average age: 66.2 years. Most reports from: US. View detailed demographics →

Is TOSITUMOMAB I-131 Getting Safer? Reports by Year

YearReportsDeathsHosp.
2017 2 0 0
2022 1 0 1

View full timeline →

What Is TOSITUMOMAB I-131 Used For?

IndicationReports
B-cell lymphoma 19
Follicle centre lymphoma, follicular grade i, ii, iii 10
Mantle cell lymphoma stage iv 5

Official FDA Label for TOSITUMOMAB I-131

Official prescribing information from the FDA-approved drug label.