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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.

TIRAGOLUMAB: 556 Adverse Event Reports & Safety Profile

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556
Total FAERS Reports
101 (18.2%)
Deaths Reported
424
Hospitalizations
556
As Primary/Secondary Suspect
41
Life-Threatening
6
Disabilities

First Report: 20170126 · Latest Report: 20250826

What Are the Most Common TIRAGOLUMAB Side Effects?

#1 Most Reported
Off label use
58 reports (10.4%)
#2 Most Reported
Hyperthyroidism
39 reports (7.0%)
#3 Most Reported
Pneumonia
29 reports (5.2%)

All TIRAGOLUMAB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 58 10.4% 10 15
Hyperthyroidism 39 7.0% 2 7
Pneumonia 29 5.2% 12 27
Pneumonitis 26 4.7% 8 25
Infusion related reaction 23 4.1% 13 8
Intentional product use issue 23 4.1% 6 1
Death 21 3.8% 21 0
Adrenal insufficiency 20 3.6% 0 11
Troponin increased 20 3.6% 0 20
Colitis 15 2.7% 2 10
Febrile neutropenia 14 2.5% 1 14
Myocarditis 14 2.5% 0 11
Acute kidney injury 10 1.8% 1 10
Immune-mediated lung disease 10 1.8% 3 9
Diarrhoea 9 1.6% 2 8
General physical health deterioration 8 1.4% 2 7
Hyponatraemia 8 1.4% 0 7
Malignant neoplasm progression 8 1.4% 8 2
Myositis 8 1.4% 1 8
Sepsis 8 1.4% 2 8

Who Reports TIRAGOLUMAB Side Effects? Age & Gender Data

Gender: 39.3% female, 60.7% male. Average age: 62.8 years. Most reports from: CN. View detailed demographics →

Is TIRAGOLUMAB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2017 2 1 2
2018 5 1 5
2019 5 2 3
2020 23 4 21
2021 191 43 162
2022 147 21 127
2023 72 12 54
2024 83 17 25
2025 28 0 25

View full timeline →

What Is TIRAGOLUMAB Used For?

IndicationReports
Hepatocellular carcinoma 75
Non-small cell lung cancer metastatic 53
Triple negative breast cancer 47
Non-small cell lung cancer 45
Oesophageal squamous cell carcinoma metastatic 39
Oesophageal squamous cell carcinoma 31
Small cell lung cancer extensive stage 30
Metastatic neoplasm 24
Lung cancer metastatic 16
Squamous cell carcinoma of lung 16

TIRAGOLUMAB vs Alternatives: Which Is Safer?

TIRAGOLUMAB vs TIRBANIBULIN TIRAGOLUMAB vs TIRZEPATIDE TIRAGOLUMAB vs TISLELIZUMAB TIRAGOLUMAB vs TISOTUMAB VEDOTIN TIRAGOLUMAB vs TISOTUMAB VEDOTIN-TFTV TIRAGOLUMAB vs TIVOZANIB TIRAGOLUMAB vs TOBRAMYCIN TIRAGOLUMAB vs TOBRAMYCIN\TOBRAMYCIN TIRAGOLUMAB vs TOCILIZUMAB TIRAGOLUMAB vs TOFACITINIB

Official FDA Label for TIRAGOLUMAB

Official prescribing information from the FDA-approved drug label.