Sutentsunitinib
According to the FDA label: SUTENT is a kinase inhibitor indicated for: • treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. ( 1.1 ) • treatment of adult patients with advanced renal cell carcinoma (RCC). ( 1.2 ) • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.
39,016 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Sutent in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Tap any term below for a plain-language definition.
Death 7,398 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Diarrhoea 4,416 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Fatigue 4,191 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Disease Progression 3,908 reports
A report that the underlying condition being treated got worse over time. This describes the course of the illness, not necessarily an effect of the drug.
Full definition in the glossary →Nausea 3,122 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Asthenia 2,458 reports
Physical weakness or lack of strength.
Full definition in the glossary →Decreased Appetite 2,317 reports
Vomiting 2,210 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Neoplasm Progression 2,019 reports
A report that a tumour grew or advanced. This describes the course of the illness, not necessarily an effect of the drug. Neoplasm is the medical term for a growth or tumour.
Full definition in the glossary →Hypertension 1,801 reports
Dysgeusia 1,697 reports
A distorted or altered sense of taste, such as a persistent metallic taste.
Full definition in the glossary →Weight Decreased 1,589 reports
Malaise 1,582 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Stomatitis 1,465 reports
Inflammation or soreness inside the mouth, including the gums, tongue, and inner cheeks.
Full definition in the glossary →Palmar-Plantar Erythrodysaesthesia Syndrome 1,453 reports
A skin reaction on the palms and soles, sometimes called hand-foot syndrome, that can occur with some cancer treatments. It causes redness, swelling, and discomfort.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 23,272 |
| Female | 12,442 |
| Unknown | 271 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 283 |
| 18-34 | 600 |
| 35-49 | 2,729 |
| 50-64 | 10,428 |
| 65-74 | 9,182 |
| 75+ | 4,740 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Sutent. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 14,192 |
| Death | 11,631 |
| Hospitalization | 11,508 |
| Non-Serious | 8,927 |
| Life-Threatening | 1,213 |
| Disability | 448 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Sutent. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 1 |
| 2006 | 777 |
| 2007 | 809 |
| 2008 | 838 |
| 2009 | 1,585 |
| 2010 | 3,423 |
| 2011 | 2,736 |
| 2012 | 3,176 |
| 2013 | 2,701 |
| 2014 | 3,143 |
| 2015 | 3,905 |
| 2016 | 3,384 |
| 2017 | 2,986 |
| 2018 | 2,531 |
| 2019 | 2,041 |
| 2020 | 1,594 |
| 2021 | 1,172 |
| 2022 | 1,066 |
| 2023 | 508 |
| 2024 | 314 |
| 2025 | 269 |
| 2026 (partial) | 57 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Sutent
In FDA adverse event reports that mention Sutent, these medications appeared most often in the same report.
- Omeprazole (1,693 reports)
- Lisinopril (1,284 reports)
- Amlodipine (1,273 reports)
- Metoprolol (1,176 reports)
- Levothyroxine (1,168 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026