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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.

CABOZANTINIB: 3,831 Adverse Event Reports & Safety Profile

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3,831
Total FAERS Reports
767 (20.0%)
Deaths Reported
2,771
Hospitalizations
3,831
As Primary/Secondary Suspect
295
Life-Threatening
80
Disabilities
None
Status

FDA Application: 213878 ·

First Report: 2013 · Latest Report: 20250821

What Are the Most Common CABOZANTINIB Side Effects?

#1 Most Reported
Diarrhoea
404 reports (10.5%)
#2 Most Reported
Fatigue
263 reports (6.9%)
#3 Most Reported
Malignant neoplasm progression
238 reports (6.2%)

All CABOZANTINIB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diarrhoea 404 10.6% 71 263
Fatigue 263 6.9% 70 175
Malignant neoplasm progression 238 6.2% 143 132
Nausea 215 5.6% 56 157
Decreased appetite 191 5.0% 44 133
Off label use 190 5.0% 71 76
Hypertension 165 4.3% 14 105
Pyrexia 162 4.2% 24 154
Vomiting 157 4.1% 46 127
Asthenia 153 4.0% 36 105
Death 153 4.0% 153 47
Palmar-plantar erythrodysaesthesia syndrome 144 3.8% 24 85
Dyspnoea 143 3.7% 40 125
Sepsis 130 3.4% 44 121
Stomatitis 126 3.3% 19 84
Pulmonary embolism 124 3.2% 29 108
General physical health deterioration 120 3.1% 47 104
Anaemia 118 3.1% 30 97
Acute kidney injury 115 3.0% 29 106
Pneumonia 114 3.0% 30 109

Who Reports CABOZANTINIB Side Effects? Age & Gender Data

Gender: 27.5% female, 72.5% male. Average age: 62.2 years. Most reports from: US. View detailed demographics →

Is CABOZANTINIB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2013 25 5 15
2014 188 69 121
2015 122 24 80
2016 115 17 82
2017 145 34 109
2018 319 56 262
2019 482 113 404
2020 644 152 509
2021 594 89 491
2022 395 73 330
2023 277 46 219
2024 73 3 40
2025 38 8 22

View full timeline →

What Is CABOZANTINIB Used For?

IndicationReports
Renal cell carcinoma 1,241
Hepatocellular carcinoma 437
Metastatic renal cell carcinoma 292
Hormone-refractory prostate cancer 170
Transitional cell carcinoma 136
Thyroid cancer 125
Non-small cell lung cancer 101
Product used for unknown indication 94
Renal cancer 77
Medullary thyroid cancer 73

CABOZANTINIB vs Alternatives: Which Is Safer?

CABOZANTINIB vs CABOZANTINIB S-MALATE CABOZANTINIB vs CAFFEINE CABOZANTINIB vs CALASPARGASE PEGOL CABOZANTINIB vs CALASPARGASE PEGOL-MKNL CABOZANTINIB vs CALCIFEDIOL CABOZANTINIB vs CALCIPOTRIENE CABOZANTINIB vs CALCITONIN CABOZANTINIB vs CALCITONIN SALMON CABOZANTINIB vs CALCITRIOL CABOZANTINIB vs CALCITRIOL\CALCIUM\ZINC

Official FDA Label for CABOZANTINIB

Official prescribing information from the FDA-approved drug label.