FDA-filed SPL labeling · retrieved through openFDA

Cabozantinib

Cabozantinib is a targeted cancer medicine used to treat advanced renal cell carcinoma, hepatocellular carcinoma, differentiated thyroid cancer, medullary thyroid cancer, and neuroendocrine tumors.

Brand names CabometyxCometriq
Drug classes Kinase Inhibitor
Rx Forms 2 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveOct 19, 2025
Clinical labels in scope 2
AvailabilityRx
Earliest approval/marketing year 2012
FDA-listed product records 30
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 22, 2026
Cabozantinib at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Cabozantinib is a powerful targeted therapy used for several advanced cancers, including kidney cancer, liver cancer, thyroid cancer, and neuroendocrine tumors. It requires careful monitoring because it can cause serious side effects including bleeding, blood clots, high blood pressure, and liver problems. Work closely with your cancer care team, report new or worsening symptoms promptly, and follow all instructions about food, surgery timing, and contraception.

📖 Cabozantinib: Patient Information Guide

A plain-language walkthrough of Cabozantinib — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Cabozantinib is a targeted cancer medicine available in two products approved for different cancers.

  • Cabometyx (tablet): Advanced renal cell carcinoma (kidney cancer) — as a single agent or combined with nivolumab for first-line treatment
  • Cabometyx (tablet): Hepatocellular carcinoma (liver cancer) in patients previously treated with sorafenib
  • Cabometyx (tablet): Locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed after prior VEGFR-targeted therapy, in adults and adolescents aged 12 and older who are radioactive iodine-refractory or ineligible
  • Cabometyx (tablet): Previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET), in adults and adolescents aged 12 and older
  • Cabometyx (tablet): Previously treated, unresectable, locally advanced or metastatic, well-differentiated extra-pancreatic neuroendocrine tumors (epNET), in adults and adolescents aged 12 and older
  • Cometriq (capsule): Progressive, metastatic medullary thyroid cancer (MTC)
⚙️How it works

Cabozantinib is a kinase inhibitor — it blocks multiple proteins called receptor tyrosine kinases, including MET, VEGFR-1, -2, and -3, RET, AXL, and several others. These proteins normally help cells grow and communicate, but in cancer they can drive tumor growth, help cancer spread (metastasize), stimulate the formation of new blood vessels that feed the tumor (a process called angiogenesis), and help tumors resist other treatments. By blocking these signals simultaneously, cabozantinib attacks cancer through several pathways at once.

💊How it's taken

Both forms of cabozantinib are taken by mouth once daily and must be taken without food.

  • Cabometyx (tablet): Take on an empty stomach — at least 1 hour before or 2 hours after eating. Swallow whole; do not crush, chew, or split. Stop at least 3 weeks before planned surgery.
  • Cometriq (capsule): Avoid food for at least 2 hours before and 1 hour after taking. Swallow capsules whole; do not open them. Avoid grapefruit and grapefruit juice.
  • For either product, if you miss a dose, skip it if your next dose is within 12 hours — do not double up.
  • Your prescriber may adjust your dose based on side effects or drug interactions; always follow their current instructions.
🤒Side effects — in detail

The most common side effects with cabozantinib include:

  • Diarrhea
  • Fatigue
  • Nausea and vomiting
  • Hand-foot skin reaction — palmar-plantar erythrodysesthesia (PPE) — redness, pain, swelling, or blisters on the palms and soles
  • High blood pressure
  • Decreased appetite and weight loss
  • Constipation
  • Mouth sores (stomatitis), rash, and musculoskeletal pain (particularly when combined with nivolumab)

More serious reactions — including severe bleeding, blood clots, liver inflammation, jaw bone damage, and abnormal holes in the gut — require immediate medical attention. Contact your care team right away if you experience anything sudden or severe.

⚠️Warnings & precautions
  • Bleeding: Cabozantinib can cause severe or fatal hemorrhage. Do not use if you have a recent history of significant bleeding. Stop the medicine before surgery to reduce this risk.
  • Gut perforations and fistulas: Holes can form in the stomach or intestines, and abnormal connections (fistulas) between organs can develop — both potentially fatal.
  • Blood clots and heart events: Serious blood clots in the veins or arteries, including pulmonary embolism and heart attack, have occurred.
  • High blood pressure: Can become severe or reach a hypertensive crisis. Blood pressure must be monitored regularly.
  • Liver toxicity: Liver enzyme elevations can be significant, especially when combined with nivolumab. Liver function should be checked before and during treatment.
  • Jaw bone damage (osteonecrosis of the jaw): Withhold cabozantinib for at least 3 weeks before invasive dental work.
  • Wound healing problems: Cabozantinib impairs wound healing — stop it before surgery and don't restart until healing is adequate.
  • Embryo-fetal toxicity: Can cause serious harm to an unborn baby. Effective contraception is required during treatment and for 4 months after the last dose.
  • RPLS (reversible posterior leukoencephalopathy syndrome): A rare brain condition — discontinue cabozantinib if it occurs.
🔀What it interacts with

Cabozantinib's levels in the body can be significantly affected by other medicines and certain foods:

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, voriconazole) — raise cabozantinib blood levels by about 38%, increasing side-effect risk; dose reduction may be needed
  • Strong CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital, St. John's Wort) — can drop cabozantinib levels by up to 77%, reducing effectiveness; dose increase may be needed
  • Grapefruit and grapefruit juice — inhibit the enzyme that breaks down cabozantinib; avoid while taking Cometriq
  • MRP2 inhibitors (e.g., ritonavir, probenecid, furosemide, abacavir) — may raise cabozantinib exposure and increase toxicity risk

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Liver disease: Dose reduction is required for moderate liver impairment; cabozantinib should be avoided in severe liver impairment
  • Kidney disease: No dose adjustment needed for mild to moderate kidney disease; experience in severe kidney disease is limited
  • Pregnancy: Can cause fetal harm — verify pregnancy status before starting, and use effective contraception during treatment and for 4 months after the last dose
  • Breastfeeding: Do not breastfeed during treatment or for 4 months after stopping
  • Fertility: Cabozantinib may impair fertility in both females and males based on animal studies
  • Adolescents (ages 12 and older): Approved for certain uses, but growth plate monitoring is recommended since bone growth may be affected
  • Children under 12: Safety and effectiveness have not been established
  • Surgery and dental procedures: Tell all your doctors and dentists you are taking cabozantinib — it must be paused before procedures to reduce bleeding and healing risks
  • Recent bleeding history: Cabozantinib should not be given to patients with a recent significant bleeding episode
🚑If you take too much

One reported case of overdose involved a patient who accidentally took twice their intended dose for 9 days. That person experienced significant memory problems, changes in mental status, and cognitive disturbance, along with weight loss and elevated kidney markers. If you suspect an overdose, contact your healthcare provider or poison control immediately.

📡Pharmacodynamics — effects in the body

Cabozantinib can affect the heart's electrical activity — specifically, it has been shown to modestly prolong the QTc interval (a measure of the heart's rhythm on an ECG) by about 10 to 15 milliseconds in the weeks after starting treatment. While no dangerous heart rhythm changes were seen in clinical trials, your care team may monitor your heart rhythm during treatment. The full relationship between blood levels of cabozantinib and its effects on the body is not completely characterized.

🔬Pharmacokinetics — how your body processes it

After taking cabozantinib by mouth, peak blood levels are typically reached within 2 to 5 hours. Eating a high-fat meal significantly increases how much the body absorbs, which is why it must be taken without food. Cabozantinib is very tightly bound to proteins in the blood (over 99%) and is broken down mainly by a liver enzyme called CYP3A4. It leaves the body slowly — the half-life (the time it takes for half the drug to clear) is roughly 55–99 hours depending on the formulation — and most of it is eliminated through the stool, with a smaller portion in urine.

📦How to store it

Store COMETRIQ at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) .

📄 Written from Cabozantinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

138

Supplements & herbs that interact with Cabozantinib

138 supplements and herbal products have documented interactions with Cabozantinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 94
  • Minor · 41
Every supplement checked against Cabozantinib — ranked by severity The full interaction hub: 3 major · 94 moderate · 41 minor · every one linked to its full report. Check Cabozantinib against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Cabozantinib — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does cabozantinib do, and why was I prescribed it?
Cabozantinib is a targeted therapy that blocks signals cancer cells use to grow and spread. Depending on which product you have, it's approved for kidney cancer, liver cancer, thyroid cancer, or certain neuroendocrine tumors. Your prescriber chose it because it targets the specific pathways driving your cancer. If you're not sure which cancer it's treating in your case, that's a great question to ask your oncologist.
Does it matter if I eat before taking my dose?
Yes — this one really matters. Both Cabometyx and Cometriq must be taken without food, because eating (especially a fatty meal) can increase how much the drug gets into your bloodstream and raise the risk of side effects. For Cabometyx, take it at least 1 hour before or 2 hours after eating. For Cometriq, avoid food for at least 2 hours before and 1 hour after your dose. Also, avoid grapefruit and grapefruit juice if you're taking Cometriq.
What side effects are most likely, and which ones should make me call the doctor right away?
The most common ones you might notice are diarrhea, fatigue, nausea, and soreness or redness on the palms of your hands or soles of your feet — that's called hand-foot syndrome. High blood pressure is also common and needs to be watched. Call your care team right away — or go to the ER — if you have severe or unusual bleeding, sudden severe belly pain, chest pain or shortness of breath, or sudden headache with vision changes. These could signal a serious problem that needs urgent attention.
I have a dentist appointment coming up — do I need to do anything special?
Yes, please tell your dentist you're on cabozantinib. This medicine can cause a serious condition called osteonecrosis of the jaw — damage to the jaw bone — especially around invasive dental procedures. If you're having any dental work that involves cutting into the gum or bone, your oncologist may want you to pause treatment for at least 3 weeks beforehand. Don't skip this conversation — coordinate between your dentist and your cancer care team.
Can I take my other medications with cabozantinib?
Some medications can seriously affect how cabozantinib works in your body. Drugs that strongly inhibit or strongly induce a liver enzyme called CYP3A4 — including certain antibiotics, antifungals, seizure medications, and even St. John's Wort — can push cabozantinib levels too high or too low. Share a complete list of everything you take, including supplements and herbal products, with your oncologist before you start and whenever something changes.
Is it safe to get pregnant or breastfeed while taking this medicine?
No — cabozantinib can seriously harm an unborn baby, so pregnancy must be avoided during treatment and for 4 months after your last dose. Both women and men need to use effective contraception during this time. Breastfeeding is also not recommended during treatment or for 4 months after stopping. If you have any questions about contraception or family planning, talk to your doctor before starting.
Is Cabozantinib available over the counter?
Cabozantinib is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Cabozantinib first available?
Cabozantinib has been available in the United States since at least 2012, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Cabozantinib?
Cabozantinib is supplied by 10 manufacturers listed in the FDA NDC Directory, including Exelixis, Inc., Sterling Chemical Malta Ltd, MSN Laboratories Private Limited.

💬 Answers drafted from Cabozantinib’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Cabozantinib comes

Cabozantinib is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Cabometyx
How this form is used
What it may be used for
  • Cabometyx is used to treat advanced renal cell carcinoma (kidney cancer), alone or with nivolumab as first-line treatment
  • Cabometyx is used to treat hepatocellular carcinoma (liver cancer) in patients previously treated with sorafenib
  • Cabometyx is used for differentiated thyroid cancer that has progressed after prior VEGFR-targeted therapy, in adults and adolescents 12 and older
  • Cabometyx is used for previously treated pancreatic and extra-pancreatic neuroendocrine tumors (NETs) in adults and adolescents 12 and older
Important instructions
  • Cabometyx must be taken on an empty stomach — at least 1 hour before eating or 2 hours after a meal
  • Swallow Cabometyx tablets whole; do not crush, chew, or split them
  • Do not take a missed Cabometyx dose if your next scheduled dose is within 12 hours
  • Stop Cabometyx at least 3 weeks before any planned surgery, including dental surgery, and do not restart for at least 2 weeks after major surgery
Available strengths 3 strengths
9 FDA-listed product records

Capsule

By mouth
Brands Cometriq
How this form is used
What it may be used for
  • Cometriq is used to treat progressive, metastatic medullary thyroid cancer (MTC)
Important instructions
  • Cometriq is taken once daily without food — avoid eating for at least 2 hours before and at least 1 hour after taking it
  • Swallow Cometriq capsules whole; do not open them
  • Avoid grapefruit, grapefruit juice, and supplements known to inhibit cytochrome P450 while taking Cometriq
  • Do not substitute Cometriq capsules with Cabometyx tablets — they are not interchangeable
Available strengths 1 strength
3 FDA-listed product records

📊 Cabozantinib across the U.S. market

How Cabozantinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

2
Dose forms
10
Manufacturers
2
Brand names
30
FDA-listed product records
2012
First marketed

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (12) · Kit (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Exelixis, Inc.60%
Sterling Chemical Malta Ltd10%
MSN Laboratories Private Limited7%
Dr Reddys Laboratories Limited3%
Escientia Advanced Sciences Private Limited3%
Piramal Healthcare (Canada) Limited3%
Other makers13%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Cabozantinib is used

A general measure of how commonly Cabozantinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Cabozantinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

3,853
Medicaid prescriptions filled (Q1–Q4 2025)
$93.8M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Cabozantinib prescribed? Of the 1,596 medications we measure, Cabozantinib ranks #1,087 by Medicaid prescriptions — more than 32% of them.

Where Cabozantinib ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Cabozantinib product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 40 mg oral tablet is the most-dispensed Cabozantinib product — about 64% of these Medicaid prescriptions.

cabozantinib 40 MG Oral Tablet Most dispensed

2,468 Medicaid prescriptions (Q1–Q4 2025) 64% of Cabozantinib prescriptions shown $58.3M gross reimbursement (before rebates) ≈ $23,623 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1790169

cabozantinib 20 MG Oral Tablet

883 Medicaid prescriptions (Q1–Q4 2025) 23% of Cabozantinib prescriptions shown $24.1M gross reimbursement (before rebates) ≈ $27,293 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1790161

cabozantinib 60 MG Oral Tablet

465 Medicaid prescriptions (Q1–Q4 2025) 12% of Cabozantinib prescriptions shown $11.2M gross reimbursement (before rebates) ≈ $24,129 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1790173

Other Cabozantinib products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

37 Medicaid prescriptions (Q2–Q4 2025) <1% of Cabozantinib prescriptions shown $179,636 gross reimbursement (before rebates) ≈ $4,855 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Cabozantinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 16 listed Cabozantinib NDCs with Medicaid activity.

🔍 Compare Cabozantinib products

A representative set of FDA-listed product records for Cabozantinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 30 of 30 products — FDA National Drug Code Directory. See every product, package size and price: browse all 30 Cabozantinib NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Cabozantinib RxCUI 1363268 2 dose forms · 5 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 1363272 In current FDA listings
    Clinical drug / strength (SCD) 20 MG RxCUI 1363273 80 MG RxCUI 1363281
  2. Dose form (SCDF) Oral Tablet RxCUI 1790160 In current FDA listings
    Clinical drug / strength (SCD) 20 MG RxCUI 1790161 40 MG RxCUI 1790169 60 MG RxCUI 1790173

Look up RxCUI 1363268 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Cabometyx Cometriq

🏭 Manufacturers & labelers

Exelixis, Inc. 18 Sterling Chemical Malta Ltd 3 MSN Laboratories Private Limited 2 Dr Reddys Laboratories Limited 1 Escientia Advanced Sciences Private Limited 1 Piramal Healthcare (Canada) Limited 1 PPL Pharma Solutions Riverview LLC 1 Shanghai Huilun Jiangsu Pharmaceutical Co., Ltd. 1 Sterling Spa 1 Valary Lab Private Limited 1

RxNorm drug class

Cabozantinib belongs to the Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) Other protein kinase inhibitors
How it works Protein Kinase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 19, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Cabozantinib.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Exelixis, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.