72/100 · Elevated
Manufactured by Exelixis, Inc.
Cabozaabinib Adverse Events: High Incidence of Gastrointestinal and Cardiovascular Reactions
112,838 FDA adverse event reports analyzed
Last updated: 2026-05-12
CABOZANTINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Exelixis, Inc.. Based on analysis of 112,838 FDA adverse event reports, CABOZANTINIB has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for CABOZANTINIB include DIARRHOEA, FATIGUE, OFF LABEL USE, NAUSEA, DECREASED APPETITE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CABOZANTINIB.
Cabozantinib has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 112,838 adverse event reports for this medication, which is primarily manufactured by Exelixis, Inc..
The most commonly reported adverse events include Diarrhoea, Fatigue, Off Label Use. Of classified reports, 43.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Diarrhoea and nausea are the most common gastrointestinal side effects.
Hypertension and increased blood pressure are significant cardiovascular concerns. Weight loss and decreased appetite are notable metabolic side effects.
Patients taking Cabozantinib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Cabozaabinib can cause hypertension and increased blood pressure, and patients should be monitored for these conditions. There are no known drug interactions, but patients should inform their healthcare provider of all medications they are taking. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cabozantinib received a safety concern score of 72/100 (elevated concern). This is based on a 43.9% serious event ratio across 43,254 classified reports. The score accounts for 112,838 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Male: 28,586, Female: 11,863, Unknown: 6. The most frequently reported age groups are age 8 (1,132 reports), age 7 (763 reports), age 65 (757 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 43,254 classified reports for CABOZANTINIB:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Cabozaabinib can cause hypertension and increased blood pressure, and patients should be monitored for these conditions. There are no known drug interactions, but patients should inform their healthcare provider of all medications they are taking.
If you are taking Cabozantinib, here are important things to know. The most commonly reported side effects include diarrhoea, fatigue, off label use, nausea, decreased appetite. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of dehydration and electrolyte imbalances, especially with gastrointestinal side effects. Regularly check blood pressure and report any significant changes to your healthcare provider. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA has not issued any specific warnings regarding Cabozaabinib, but patients should report any serious adverse events to their healthcare provider immediately. Regular monitoring for blood pressure and weight changes is recommended.
The FDA has received approximately 112,838 adverse event reports associated with Cabozantinib. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Cabozantinib include Diarrhoea, Fatigue, Off Label Use, Nausea, Decreased Appetite. By volume, the top reported reactions are: Diarrhoea (8,862 reports), Fatigue (7,232 reports), Off Label Use (5,626 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Cabozantinib.
Out of 43,254 classified reports, 18,983 (43.9%) were classified as serious and 24,271 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Cabozantinib break down by patient sex as follows: Male: 28,586, Female: 11,863, Unknown: 6. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Cabozantinib adverse events are: age 8: 1,132 reports, age 7: 763 reports, age 65: 757 reports, age 68: 745 reports, age 70: 738 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Cabozantinib adverse event reports is Exelixis, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Cabozantinib include: Malignant Neoplasm Progression, Blood Pressure Increased, Palmar-Plantar Erythrodysaesthesia Syndrome, Weight Decreased, Death. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Cabozantinib to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Cabozantinib has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Diarrhoea and nausea are the most common gastrointestinal side effects.
Key safety signals identified in Cabozantinib's adverse event data include: Diarrhoea and nausea are the most frequently reported gastrointestinal reactions.. Hypertension and increased blood pressure are common cardiovascular side effects.. Decreased appetite and weight loss are significant metabolic concerns.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Cabozaabinib can cause hypertension and increased blood pressure, and patients should be monitored for these conditions. There are no known drug interactions, but patients should inform their healthcare provider of all medications they are taking. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cabozantinib.
Monitor for signs of dehydration and electrolyte imbalances, especially with gastrointestinal side effects. Regularly check blood pressure and report any significant changes to your healthcare provider.
Cabozantinib has 112,838 adverse event reports on file with the FDA. Hypertension and increased blood pressure are significant cardiovascular concerns. The volume of reports for Cabozantinib reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has not issued any specific warnings regarding Cabozaabinib, but patients should report any serious adverse events to their healthcare provider immediately. Regular monitoring for blood pressure and weight changes is recommended. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with CABOZANTINIB:
Drugs related to CABOZANTINIB based on therapeutic use, drug class, or shared indications: