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Cabozantinib side effects: what 47,753 FDA adverse event reports show

Cabozantinib · Cabometyx · 1,129 reaction terms · 172,707 drug–reaction co-reports · data 2026-09-14
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Drug class

Kinase inhibitor

FDA label, Indications wording

Brand names

Cabometyx

openFDA label

Who reports

47,753 reports · 44% serious · 5,351 with death outcome · 30% female

openFDA FAERS counts, all years, deduplication not applied

Used for

CABOMETYX is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab ( 1.1 ) patients with hepatoc.

FDA label, Indications and Usage

What it is

CABOMETYX is the ( S )-malate salt of cabozantinib, a kinase inhibitor. Cabozantinib ( S )-malate is described chemically as N -(4-(6,7-dimethoxyquinolin-4-yloxy)phenyl)- N' -(4-fluorophenyl)cyclopropane-1,1-dicarboxamide, (2 S )-hydroxybutanedioate.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 5Labeled (related wording) 4Likely indication confounding 5Reporting / coding artifact 2Lab value / disease marker 3Not in label — unassessed 21
What the badges mean

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,089 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Scrotal dermatitis13112.4
61.1–206.8ROR 112.4 · calibrated p 5e-7 ✓
79.3 EB05 49.3 · IC025 +3.4
3/3 methods agree
Not in label — unassessed–not reported in cached trials
Palmar-plantar erythrodysaesthesia syndrome3,11367.4
64.9–69.9ROR 72.0 · calibrated p 1e-6 ✓
58.4 EB05 56.7 · IC025 +5.8
3/3 methods agree
Not in label — unassessedserious PRR 45.8NCT01605227: 3/681 (0.4%) on Cabozantinib (serious AE)
Renal cell carcinoma recurrent1566.2
38.4–113.9ROR 66.2 · calibrated p 9e-6 ✓
53.8 EB05 34.6 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=15not reported in cached trials
Renal cell carcinoma50650.1
45.7–54.9ROR 50.7 · calibrated p 1e-5 ✓
44.9 EB05 41.8 · IC025 +5.3
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=506 · 94% clinicianNCT03937219: 13/426 (3.1%) on Cabozantinib; 15/423 (3.5%) control (serious AE)
Thyroid hormones increased10749.6
40.6–60.6ROR 49.7 · calibrated p 2e-5 ✓
44.3 EB05 37.7 · IC025 +4.9
3/3 methods agree
Lab value / disease markerserious n=32 · 89% consumernot reported in cached trials
Taste disorder1,99248.4
46.3–50.7ROR 50.5 · calibrated p 1e-5 ✓
43.6 EB05 42.0 · IC025 +5.4
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 34.6 · 77% consumernot reported in cached trials
Thyroid hormones decreased7243.6
34.3–55.6ROR 43.7 · calibrated p 4e-5 ✓
39.4 EB05 32.3 · IC025 +4.6
3/3 methods agree
Lab value / disease markerserious n=22 · 100% consumernot reported in cached trials
Hyperkeratosis46440.1
36.5–44.1ROR 40.5 · calibrated p 5e-5 ✓
36.8 EB05 34.0 · IC025 +5.0
3/3 methods agree
Not in label — unassessedserious n=106 · 85% consumernot reported in cached trials
Renal cancer recurrent1238.7
21.4–69.9ROR 38.7 · calibrated p 2e-4 ✓
33.9 EB05 20.6 · IC025 +2.9
3/3 methods agree
Not in label — unassessedserious n=8not reported in cached trials
Scrotal erythema1234.1
19.0–61.4ROR 34.1 · calibrated p 4e-4 ✓
30.3 EB05 18.4 · IC025 +2.9
3/3 methods agree
Not in label — unassessed–not reported in cached trials
Renal cancer metastatic5633.9
25.8–44.5ROR 33.9 · calibrated p 2e-4 ✓
31.2 EB05 24.9 · IC025 +4.2
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=55not reported in cached trials
Genital blister1932.5
20.4–51.7ROR 32.5 · calibrated p 4e-4 ✓
29.5 EB05 19.9 · IC025 +3.3
3/3 methods agree
Not in label — unassessed–not reported in cached trials
Metastases to pancreas3031.8
21.9–46.0ROR 31.8 · calibrated p 3e-4 ✓
29.2 EB05 21.4 · IC025 +3.7
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=28not reported in cached trials
Nasal ulcer10129.5
24.1–36.1ROR 29.6 · calibrated p 3e-4 ✓
27.5 EB05 23.3 · IC025 +4.3
3/3 methods agree
Not in label — unassessedserious n=23 · 100% consumernot reported in cached trials
Alpha 1 foetoprotein increased4026.0
18.9–35.8ROR 26.0 · calibrated p 7e-4 ✓
24.3 EB05 18.6 · IC025 +3.7
3/3 methods agree
Lab value / disease markerserious n=20not reported in cached trials
Tongue discomfort22725.0
21.9–28.6ROR 25.1 · calibrated p 7e-4 ✓
23.6 EB05 21.2 · IC025 +4.3
3/3 methods agree
Not in label — unassessedserious n=50 · 92% consumernot reported in cached trials
Hair colour changes66924.6
22.8–26.6ROR 25.0 · calibrated p 7e-4 ✓
23.3 EB05 21.9 · IC025 +4.4
3/3 methods agree
Not in label — unassessedserious n=127 · 72% consumernot reported in cached trials
Genital rash7524.4
19.4–30.8ROR 24.5 · calibrated p 9e-4 ✓
23.1 EB05 19.0 · IC025 +4.0
3/3 methods agree
Labeled adverse reaction
exact term
serious n=12 · 79% consumernot reported in cached trials
Glossitis18724.3
21.0–28.2ROR 24.4 · calibrated p 8e-4 ✓
23.0 EB05 20.4 · IC025 +4.2
3/3 methods agree
Labeled adverse reaction
exact term
serious n=44 · 85% consumernot reported in cached trials
Metastatic renal cell carcinoma9623.9
19.5–29.4ROR 24.0 · calibrated p 9e-4 ✓
22.6 EB05 19.1 · IC025 +4.0
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious n=94NCT03937219: 2/423 (0.5%) control (serious AE)
Stomatitis (mouth sores)2,89822.0
21.2–22.8ROR 23.3 · calibrated p 9e-4 ✓
21.0 EB05 20.3 · IC025 +4.3
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 13.6 · 74% consumerNCT01605227: 1/342 (0.3%) on Cabozantinib (serious AE)
Scrotal ulcer1220.8
11.7–37.2ROR 20.8 · calibrated p 0.004 ✓
19.0 EB05 11.0 · IC025 +2.5
3/3 methods agree
Not in label — unassessed–not reported in cached trials
Hand-foot-and-mouth disease3620.5
14.7–28.7ROR 20.5 · calibrated p 0.002 ✓
19.4 EB05 14.6 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious n=7 · ♀ 53% (drug 30%) · 78% consumernot reported in cached trials
Skin ulcer1,13520.1
19.0–21.4ROR 20.6 · calibrated p 0.002 ✓
19.3 EB05 18.4 · IC025 +4.2
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 7.6 · 85% consumerNCT01605227: 2/681 (0.3%) on Cabozantinib (serious AE)
Tongue erythema3519.7
14.1–27.7ROR 19.7 · calibrated p 0.003 ✓
18.7 EB05 14.0 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious n=16 · ♀ 51% (drug 30%) · 80% consumernot reported in cached trials
Product selection error4719.5
14.6–26.1ROR 19.5 · calibrated p 0.003 ✓
18.6 EB05 14.5 · IC025 +3.5
3/3 methods agree
Reporting / coding artifact100% cliniciannot reported in cached trials
Tongue ulceration13117.6
14.8–21.0ROR 17.7 · calibrated p 0.004 ✓
16.9 EB05 14.6 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious n=39 · 93% consumernot reported in cached trials
Metastases to abdominal cavity1917.5
11.1–27.7ROR 17.5 · calibrated p 0.006 ✓
16.4 EB05 10.7 · IC025 +2.8
3/3 methods agree
Not in label — unassessedserious n=17not reported in cached trials
Blister2,09717.0
16.3–17.8ROR 17.8 · calibrated p 0.003 ✓
16.4 EB05 15.8 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious PRR 6.1 · 88% consumernot reported in cached trials
Diverticulitis intestinal perforated1216.7
9.4–29.7ROR 16.7 · calibrated p 0.008 ✓
15.0 EB05 8.2 · IC025 +2.3
3/3 methods agree
Not in label — unassessedserious n=12not reported in cached trials
Plicated tongue1716.4
10.1–26.7ROR 16.4 · calibrated p 0.007 ✓
15.2 EB05 9.5 · IC025 +2.7
3/3 methods agree
Not in label — unassessed–not reported in cached trials
Clear cell renal cell carcinoma2415.9
10.6–23.9ROR 15.9 · calibrated p 0.007 ✓
15.0 EB05 10.3 · IC025 +2.9
3/3 methods agree
Not in label — unassessedserious n=24 · 100% clinicianNCT03937219: 2/426 (0.5%) on Cabozantinib (serious AE)
Hepatocellular carcinoma26615.8
14.0–17.9ROR 15.9 · calibrated p 0.006 ✓
15.3 EB05 13.8 · IC025 +3.7
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious PRR 20.0 · 98% cliniciannot reported in cached trials
Malignant neoplasm progression3,41915.2
14.7–15.7ROR 16.3 · calibrated p 0.005 ✓
14.7 EB05 14.3 · IC025 +3.8
3/3 methods agree
Reporting / coding artifactserious PRR 15.4NCT01605227: 1/681 (0.1%) on Cabozantinib (serious AE)
Pharyngeal ulceration4415.0
11.1–20.3ROR 15.0 · calibrated p 0.008 ✓
14.3 EB05 11.0 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious n=16 · 82% consumernot reported in cached trials
Immune-mediated hepatic disorder6214.7
11.4–18.9ROR 14.7 · calibrated p 0.009 ✓
14.1 EB05 11.3 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=62 · 100% cliniciannot reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Cabozantinib as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (9 of 40 signal terms matched).

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Diarrhoea (diarrhea)9,4496.5
6.4–6.7ROR 7.9 · calibrated p 0.069
6.4 EB05 6.3 · IC025 +2.7
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 5.4 · 71% consumerNCT01605227: 10/681 (1.5%) on Cabozantinib (serious AE)
Fatigue (tiredness)7,6964.4
4.3–4.5ROR 5.0 · calibrated p 0.231
4.3 EB05 4.3 · IC025 +2.1
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.5 · 81% consumerNCT01605227: 20/681 (2.9%) on Cabozantinib (serious AE)
Off label use (used outside approved label)6,8863.5
3.4–3.6ROR 3.9 · calibrated p 0.392
3.5 EB05 3.4 · IC025 +1.8
3/3 methods agree
Reporting / coding artifactserious PRR 2.6not reported in cached trials
Nausea4,9892.8
2.7–2.9ROR 3.0 · calibrated p 0.627
2.8 EB05 2.7 · IC025 +1.4
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.5 · 77% consumerNCT01605227: 23/681 (3.4%) on Cabozantinib (serious AE)
Decreased appetite (loss of appetite)4,6208.9
8.7–9.2ROR 9.8 · calibrated p 0.035 ✓
8.8 EB05 8.5 · IC025 +3.1
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 7.0NCT01605227: 15/681 (2.2%) on Cabozantinib (serious AE)
Malignant neoplasm progression3,41915.2
14.7–15.7ROR 16.3 · calibrated p 0.005 ✓
14.7 EB05 14.3 · IC025 +3.8
3/3 methods agree
Reporting / coding artifactserious PRR 15.4NCT01605227: 1/681 (0.1%) on Cabozantinib (serious AE)
Blood pressure increased3,1969.3
9.0–9.7ROR 9.9 · calibrated p 0.033 ✓
9.2 EB05 8.9 · IC025 +3.1
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 5.5 · 87% consumernot reported in cached trials
Palmar-plantar erythrodysaesthesia syndrome3,11367.4
64.9–69.9ROR 72.0 · calibrated p 1e-6 ✓
58.4 EB05 56.7 · IC025 +5.8
3/3 methods agree
Not in label — unassessedserious PRR 45.8NCT01605227: 3/681 (0.4%) on Cabozantinib (serious AE)
Weight decreased (weight loss)3,0384.8
4.7–5.0ROR 5.1 · calibrated p 0.226
4.8 EB05 4.6 · IC025 +2.2
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.8 · 78% consumerNCT01605227: 237/681 (34.8%) on Cabozantinib
Death2,9081.5
1.4–1.5ROR 1.5 · calibrated p 0.652
1.5 EB05 1.4 · IC025 +0.5Outcome field, not a reactionserious PRR 1.9NCT01605227: 4/681 (0.6%) on Cabozantinib (serious AE)
Stomatitis (mouth sores)2,89822.0
21.2–22.8ROR 23.3 · calibrated p 9e-4 ✓
21.0 EB05 20.3 · IC025 +4.3
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 13.6 · 74% consumerNCT01605227: 1/342 (0.3%) on Cabozantinib (serious AE)
Constipation2,3774.9
4.7–5.1ROR 5.1 · calibrated p 0.227
4.8 EB05 4.7 · IC025 +2.2
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 4.2 · 83% consumerNCT01605227: 12/681 (1.8%) on Cabozantinib (serious AE)
Vomiting2,2262.1
2.0–2.2ROR 2.1 · calibrated p 0.980
2.1 EB05 2.0 · IC025 +1.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 1.9 · 72% consumerNCT01605227: 28/681 (4.1%) on Cabozantinib (serious AE)
Asthenia (weakness)2,1482.5
2.4–2.6ROR 2.6 · calibrated p 0.777
2.5 EB05 2.4 · IC025 +1.3
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.2NCT01605227: 18/681 (2.6%) on Cabozantinib (serious AE)
Blister2,09717.0
16.3–17.8ROR 17.8 · calibrated p 0.003 ✓
16.4 EB05 15.8 · IC025 +4.0
3/3 methods agree
Not in label — unassessedserious PRR 6.1 · 88% consumernot reported in cached trials

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Cabozantinib?

In FDA FAERS, the most frequently co-reported reaction terms for Cabozantinib are diarrhoea, fatigue, nausea, decreased appetite, blood pressure increased, palmar-plantar erythrodysaesthesia syndrome. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Cabozantinib have an FDA boxed warning?

No. The FDA label retrieved for Cabozantinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Cabozantinib causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.