What the label lists and what reports show
Cabozantinib side effects
Cabozantinib's FDA label: “The most common (≥ 20%) adverse reactions are: as a single agent: diarrhea, fatigue, PPE, decreased appetite, hypertension, nausea, vomiting, weight decreased, constipation.” FAERS holds 47,766 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (9,449 reports).
- No generic listed
Check it at the source: the cabozantinib FDA label on DailyMed (effective October 19, 2025, Exelixis, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of CABOMETYX?CABOMETYX may cause serious side effects, including: bleeding (hemorrhage). CABOMETYX can cause severe bleeding that may lead to death. Tell your healthcare provider right away if you get any signs of bleeding during treatment with CABOMETYX, including: coughing up blood or blood clots vomiting blood or if your vomit looks like coffee-grounds red or black (looks like tar) stools menstrual bleeding that is heavier than normal any unusual or heavy bleeding a tear in your stomach or intestinal wall (perforation) or an abnormal connection between 2 parts of your body (fistula). Tell your healthcare provider right away if you get tenderness or pain in your stomach-area (abdomen) that is severe or that does not go away. blood clots, stroke, heart attack, and chest pain. […]
Source: FDA drug label, Exelixis, Inc., effective October 19, 2025 (SPL set 3850cce2-6137-42e5-a792-d318c4a4b3b5), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common (≥ 20%) adverse reactions are: as a single agent: diarrhea, fatigue, PPE, decreased appetite, hypertension, nausea, vomiting, weight decreased, constipation.
Table 5. Adverse Reactions Occurring in ≥ 10% Patients Who Received CABOMETYX in METEOR
| Reaction | All Grades National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events… | Grades 3-4 | All Grades | Grades 3-4 |
|---|---|---|---|---|
| Diarrhea | 74 | 11 | 28 | 2 |
| Nausea | 50 | 4 | 28 | <1 |
| Vomiting | 32 | 2 | 14 | <1 |
| Stomatitis | 22 | 2 | 24 | 2 |
| Constipation | 25 | <1 | 19 | <1 |
| Abdominal pain Includes the following terms: abdominal pain, abdominal pain upper, and… | 23 | 4 | 13 | 2 |
| Dyspepsia | 12 | <1 | 5 | 0 |
| Fatigue | 56 | 9 | 47 | 7 |
| Mucosal inflammation | 19 | <1 | 23 | 3 |
| Asthenia | 19 | 4 | 16 | 2 |
| Decreased appetite | 46 | 3 | 34 | <1 |
| Palmar-plantar erythrodysesthesia | 42 | 8 | 6 | <1 |
| Rash Includes the following terms: rash, rash erythematous, rash follicular, rash… | 23 | <1 | 43 | <1 |
| Dry skin | 11 | 0 | 10 | 0 |
| Hypertension Includes the following terms hypertension, blood pressure increased,… | 39 | 16 | 8 | 3 |
| Weight decreased | 31 | 2 | 12 | 0 |
| Dysgeusia | 24 | 0 | 9 | 0 |
| Headache | 11 | <1 | 12 | <1 |
| Dizziness | 11 | 0 | 7 | 0 |
| Hypothyroidism | 21 | 0 | <1 | <1 |
| Dysphonia | 20 | <1 | 4 | 0 |
| Dyspnea | 19 | 3 | 29 | 4 |
| Cough | 18 | <1 | 33 | <1 |
| Anemia | 17 | 5 | 38 | 16 |
| Pain in extremity | 14 | 1 | 8 | <1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed elsewhere in the labeling: Hemorrhage [see Warnings and Precautions (5.1) ] Perforations and Fistulas [see Warnings and Precautions (5.2) ] Thromboembolic Events [see Warnings and Precautions (5.3) ] Hypertension and Hypertensive Crisis [see Warnings and Precautions (5.4) ] Cardiac Failure [see Warnings and Precautions (5.5) ] Diarrhea [see Warnings and Precautions (5.6) ] Palmar-plantar Erythrodysesthesia [see Warnings and Precautions (5.7) ] Hepatotoxicity [see Warnings and Precautions (5.8) ] Adrenal Insufficiency [see Warnings and Precautions (5.9) ] Proteinuria [see Warnings and Precautions (5.10) ] Osteonecrosis of the Jaw [see Warnings and Precautions (5.11) ] Impaired Wound Healing [see Warnings and Precautions (5.12) ] Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.13) ] Thyroid Dysfunction [see Warnings and Precautions (5.14) ] Hypocalcemia [see Warnings and Precautions (5.15) ] The most common (≥ 20%) adverse reactions are: as a single agent: diarrhea, fatigue, PPE, decreased appetite, hypertension, nausea, vomiting, weight decreased, constipation. …
Source: FDA drug label, Exelixis, Inc., effective October 19, 2025 (SPL set 3850cce2-6137-42e5-a792-d318c4a4b3b5), via openFDA; the full label on DailyMed
What do FAERS reports show?
47,766 reports list cabozantinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,351 are coded as a death and 9,123 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 15 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Cabozantinib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions