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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.

SUNITINIB: 1,782 Adverse Event Reports & Safety Profile

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1,782
Total FAERS Reports
306 (17.2%)
Deaths Reported
430
Hospitalizations
1,782
As Primary/Secondary Suspect
66
Life-Threatening
20
Disabilities

First Report: 20030622 · Latest Report: 20250601

What Are the Most Common SUNITINIB Side Effects?

#1 Most Reported
Disease progression
280 reports (15.7%)
#2 Most Reported
Drug ineffective
243 reports (13.6%)
#3 Most Reported
Malignant neoplasm progression
242 reports (13.6%)

All SUNITINIB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Disease progression 280 15.7% 44 36
Drug ineffective 243 13.6% 50 66
Malignant neoplasm progression 242 13.6% 80 32
Fatigue 132 7.4% 22 26
Diarrhoea 129 7.2% 24 38
Osteonecrosis of jaw 115 6.5% 2 8
Hypertension 99 5.6% 7 17
Off label use 99 5.6% 11 20
Thrombocytopenia 96 5.4% 21 35
Death 85 4.8% 83 6
Palmar-plantar erythrodysaesthesia syndrome 84 4.7% 7 13
Neutropenia 80 4.5% 15 15
Gastrointestinal stromal tumour 75 4.2% 25 8
Anaemia 74 4.2% 10 33
Nausea 69 3.9% 12 31
Asthenia 59 3.3% 11 27
Hypothyroidism 59 3.3% 5 11
Metastases to liver 58 3.3% 21 9
Vomiting 58 3.3% 10 31
Drug resistance 57 3.2% 6 5

Who Reports SUNITINIB Side Effects? Age & Gender Data

Gender: 38.9% female, 61.1% male. Average age: 59.7 years. Most reports from: US. View detailed demographics →

Is SUNITINIB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 1 1
2004 3 2 0
2006 5 2 0
2007 4 0 2
2008 6 2 4
2009 12 3 9
2010 5 1 1
2011 23 4 9
2012 8 2 3
2013 13 0 7
2014 29 12 9
2015 28 5 19
2016 35 5 12
2017 23 5 6
2018 25 6 19
2019 26 5 10
2020 18 2 7
2021 36 4 11
2022 93 18 50
2023 67 12 32
2024 37 7 9
2025 17 1 10

View full timeline →

What Is SUNITINIB Used For?

IndicationReports
Gastrointestinal stromal tumour 297
Metastatic renal cell carcinoma 229
Product used for unknown indication 202
Renal cell carcinoma 143
Clear cell renal cell carcinoma 95
Renal cancer 80
Neoplasm malignant 56
Pancreatic neuroendocrine tumour 37
Metastases to bone 31
Pancreatic neuroendocrine tumour metastatic 29

SUNITINIB vs Alternatives: Which Is Safer?

SUNITINIB vs SUNITINIB MALATE SUNITINIB vs SUTENT SUNITINIB vs SUTIMLIMAB-JOME SUNITINIB vs SUVOREXANT SUNITINIB vs SUZETRIGINE SUNITINIB vs SYMBICORT SUNITINIB vs SYNAGIS SUNITINIB vs SYNTHROID SUNITINIB vs TACROLIMUS SUNITINIB vs TACROLIMUS\TACROLIMUS ANHYDROUS

Official FDA Label for SUNITINIB

Official prescribing information from the FDA-approved drug label.