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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.

TEBENTAFUSP-TEBN: 350 Adverse Event Reports & Safety Profile

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350
Total FAERS Reports
45 (12.9%)
Deaths Reported
112
Hospitalizations
350
As Primary/Secondary Suspect
14
Life-Threatening
Prescription
Status

FDA Application: 761228 ·

First Report: 20210101 · Latest Report: 20250902

What Are the Most Common TEBENTAFUSP-TEBN Side Effects?

#1 Most Reported
Pyrexia
63 reports (18.0%)
#2 Most Reported
Cytokine release syndrome
59 reports (16.9%)
#3 Most Reported
Hypotension
47 reports (13.4%)

All TEBENTAFUSP-TEBN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pyrexia 63 18.0% 7 32
Cytokine release syndrome 59 16.9% 11 26
Hypotension 47 13.4% 7 33
Rash 43 12.3% 2 21
Disease progression 42 12.0% 9 6
Chills 38 10.9% 4 21
Product dose omission issue 37 10.6% 0 11
Malignant neoplasm progression 32 9.1% 3 4
Nausea 29 8.3% 2 12
Vomiting 22 6.3% 1 13
Pruritus 21 6.0% 0 14
Death 17 4.9% 17 4
Fatigue 15 4.3% 1 6
Asthenia 12 3.4% 4 9
Hypoxia 12 3.4% 3 7
Tachycardia 12 3.4% 6 8
Headache 10 2.9% 1 4
Oxygen saturation decreased 10 2.9% 1 7
Blood pressure decreased 9 2.6% 0 7
Diarrhoea 9 2.6% 0 8

Who Reports TEBENTAFUSP-TEBN Side Effects? Age & Gender Data

Gender: 53.0% female, 47.0% male. Average age: 68.3 years. Most reports from: US. View detailed demographics →

Is TEBENTAFUSP-TEBN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2021 3 0 2
2022 51 6 20
2023 32 3 14
2024 69 11 32
2025 40 1 25

View full timeline →

What Is TEBENTAFUSP-TEBN Used For?

IndicationReports
Product used for unknown indication 127
Metastatic ocular melanoma 114
Uveal melanoma 72
Choroid melanoma 10
Metastatic malignant melanoma 7

TEBENTAFUSP-TEBN vs Alternatives: Which Is Safer?

TEBENTAFUSP-TEBN vs TECFIDERA TEBENTAFUSP-TEBN vs TECHNETIUM TC-99M TEBENTAFUSP-TEBN vs TECHNETIUM TC-99M MEDRONATE TEBENTAFUSP-TEBN vs TECHNETIUM TC-99M OXIDRONATE TEBENTAFUSP-TEBN vs TECHNETIUM TC-99M PERTECHNETATE TEBENTAFUSP-TEBN vs TECHNETIUM TC-99M SESTAMIBI TEBENTAFUSP-TEBN vs TECHNETIUM TC-99M TETROFOSMIN TEBENTAFUSP-TEBN vs TECLISTAMAB TEBENTAFUSP-TEBN vs TECLISTAMAB-CQYV TEBENTAFUSP-TEBN vs TEDIZOLID

Official FDA Label for TEBENTAFUSP-TEBN

Official prescribing information from the FDA-approved drug label.