Votrientpazopanib
According to the FDA label: VOTRIENT is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). ( 1.1 ) advanced soft tissue sarcoma (STS) who have received prior chemotherapy. ( 1.2 ) Limitations of Use : The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. 1.1 Renal Cell Carcinoma VOTRIENT ® is indicated for the treatment of adults with advanced renal cell carcinoma (RCC).
22,470 adverse event reports submitted to the FDA (2009–2026)
Top Reported Adverse Events
The most frequently reported events in association with Votrient 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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Death 4,271 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 3,298 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 2,221 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Nausea 2,198 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Decreased Appetite 1,270 reports
Vomiting 1,226 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 1,221 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Malignant Neoplasm Progression 1,162 reports
A report that a cancer grew or spread. This describes the course of the illness, not necessarily an effect of the drug. Malignant neoplasm is the medical term for a cancerous growth.
Full definition in the glossary →Hypertension 1,070 reports
Malaise 819 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Weight Decreased 815 reports
Asthenia 803 reports
Physical weakness or lack of strength.
Full definition in the glossary →Hair Colour Changes 774 reports
A change in hair color. Also spelled color in American English.
Full definition in the glossary →Disease Progression 758 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 →Blood Pressure Increased 738 reports
A reading showing higher than normal blood pressure. Similar to hypertension, which describes the ongoing condition.
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 | 12,024 |
| Female | 8,210 |
| Unknown | 84 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 152 |
| 18-34 | 445 |
| 35-49 | 1,062 |
| 50-64 | 4,138 |
| 65-74 | 3,366 |
| 75+ | 2,222 |
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 Votrient. 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 |
|---|---|
| Non-Serious | 8,783 |
| Other Serious | 6,536 |
| Death | 6,004 |
| Hospitalization | 4,183 |
| Life-Threatening | 573 |
| Disability | 293 |
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 Votrient. 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 |
|---|---|
| 2009 | 1 |
| 2010 | 212 |
| 2011 | 694 |
| 2012 | 968 |
| 2013 | 1,676 |
| 2014 | 2,372 |
| 2015 | 3,187 |
| 2016 | 2,244 |
| 2017 | 2,435 |
| 2018 | 2,329 |
| 2019 | 2,003 |
| 2020 | 1,398 |
| 2021 | 1,136 |
| 2022 | 850 |
| 2023 | 615 |
| 2024 | 198 |
| 2025 | 113 |
| 2026 (partial) | 39 |
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 Votrient
In FDA adverse event reports that mention Votrient, these medications appeared most often in the same report.
- Amlodipine (657 reports)
- Aspirin (573 reports)
- Lisinopril (538 reports)
- Metoprolol (518 reports)
- Ergocalciferol (465 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