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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.

TREMELIMUMAB\TREMELIMUMAB-ACTL: 1,173 Adverse Event Reports & Safety Profile

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1,173
Total FAERS Reports
328 (28.0%)
Deaths Reported
428
Hospitalizations
1,173
As Primary/Secondary Suspect
165
Life-Threatening
17
Disabilities

First Report: 20230101 · Latest Report: 20250917

What Are the Most Common TREMELIMUMAB\TREMELIMUMAB-ACTL Side Effects?

#1 Most Reported
Diarrhoea
109 reports (9.3%)
#2 Most Reported
Death
106 reports (9.0%)
#3 Most Reported
Malignant neoplasm progression
101 reports (8.6%)

All TREMELIMUMAB\TREMELIMUMAB-ACTL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diarrhoea 109 9.3% 26 63
Death 106 9.0% 106 4
Malignant neoplasm progression 101 8.6% 38 12
Cytokine release syndrome 86 7.3% 14 34
Immune-mediated enterocolitis 63 5.4% 18 40
Liver disorder 62 5.3% 8 19
Pyrexia 61 5.2% 11 28
Rash 60 5.1% 4 24
Colitis 47 4.0% 12 24
Immune-mediated hepatic disorder 45 3.8% 6 19
Interstitial lung disease 41 3.5% 20 23
Hepatic function abnormal 39 3.3% 6 18
Adrenal insufficiency 30 2.6% 5 11
Myocarditis 29 2.5% 14 17
Malaise 28 2.4% 6 11
Neutrophil count decreased 26 2.2% 8 11
Platelet count decreased 26 2.2% 3 13
Decreased appetite 25 2.1% 11 8
Acute kidney injury 22 1.9% 7 15
Enterocolitis 22 1.9% 4 9

Who Reports TREMELIMUMAB\TREMELIMUMAB-ACTL Side Effects? Age & Gender Data

Gender: 18.5% female, 81.5% male. Average age: 71.1 years. Most reports from: JP. View detailed demographics →

Is TREMELIMUMAB\TREMELIMUMAB-ACTL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2023 308 87 175
2024 168 50 88
2025 77 24 33

View full timeline →

What Is TREMELIMUMAB\TREMELIMUMAB-ACTL Used For?

IndicationReports
Hepatocellular carcinoma 589
Non-small cell lung cancer 343
Hepatic cancer 12
Lung neoplasm malignant 12
Non-small cell lung cancer stage iv 9
Product used for unknown indication 5

TREMELIMUMAB\TREMELIMUMAB-ACTL vs Alternatives: Which Is Safer?

TREMELIMUMAB\TREMELIMUMAB-ACTL vs TRENBOLONE TREMELIMUMAB\TREMELIMUMAB-ACTL vs TREOSULFAN TREMELIMUMAB\TREMELIMUMAB-ACTL vs TREPROSTINIL TREMELIMUMAB\TREMELIMUMAB-ACTL vs TREPROSTINIL DIOLAMINE TREMELIMUMAB\TREMELIMUMAB-ACTL vs TRETINOIN TREMELIMUMAB\TREMELIMUMAB-ACTL vs TRIAMCINOLONE TREMELIMUMAB\TREMELIMUMAB-ACTL vs TRIAMCINOLONE ACETONIDE TREMELIMUMAB\TREMELIMUMAB-ACTL vs TRIAMCINOLONE HEXACETONIDE TREMELIMUMAB\TREMELIMUMAB-ACTL vs TRIAMTERENE TREMELIMUMAB\TREMELIMUMAB-ACTL vs TRIATEC

Official FDA Label for TREMELIMUMAB\TREMELIMUMAB-ACTL

Official prescribing information from the FDA-approved drug label.