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Cabometyx: Uses, Side Effects and Dosage

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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Cabometyx

What is CABOMETYX?

CABOMETYX is a prescription medicine used to treat:

  • people with advanced kidney cancer (renal cell carcinoma). CABOMETYX may be used:

    • alone to treat people with renal cell carcinoma (RCC) that has spread (advanced RCC).
    • in combination with nivolumab when your cancer has spread (advanced RCC), and you have not already had treatment for your advanced RCC.
  • people with liver cancer (hepatocellular carcinoma) who have been previously treated with the medicine sorafenib.

  • adults and children 12 years of age and older who have a type of thyroid cancer called differentiated thyroid cancer (DTC), that has spread (locally advanced or metastatic), and,

    • has progressed after treatment with a VEGFR-targeted treatment, and
    • your DTC can no longer be treated with radioactive iodine, or you are not able to receive radioactive iodine treatment
  • adults and children 12 years of age and older who have a type of cancer called pancreatic neuroendocrine tumors (pNET) or extra-pancreatic neuroendocrine tumors (epNET) that has been previously treated, cannot be treated by surgery, and has spread (locally advanced or metastatic).

It is not known if CABOMETYX is safe and effective in children younger than 12 years of age.

Before you take CABOMETYX, tell your healthcare provider about all of your medical conditions, including if you:

  • have had a liver problem other than liver cancer
  • have a recent history of bleeding, including coughing up or vomiting blood, or black tarry stools.
  • have an open or healing wound
  • have high blood pressure
  • have heart problems
  • have a low calcium level in your blood (hypocalcemia)
  • plan to have any surgery, dental procedure, or have had a recent surgery. You should stop taking CABOMETYX at least 3 weeks before planned surgery. See "What are the possible side effects of CABOMETYX?"

  • are pregnant, or plan to become pregnant. CABOMETYX can harm your unborn baby.

    • If you are able to become pregnant, your healthcare provider will check your pregnancy status before you start treatment with CABOMETYX.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment and for 4 months after your last dose of CABOMETYX.
    • Talk to your healthcare provider about birth control methods that may be right for you.
    • If you become pregnant or think you are pregnant, tell your healthcare provider right away.

  • are breastfeeding or plan to breastfeed. It is not known if CABOMETYX passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose of CABOMETYX.

Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, and herbal supplements. CABOMETYX and certain other medicines may affect each other causing side effects.

How should I take CABOMETYX?

  • Take CABOMETYX exactly as your healthcare provider tells you to take it.
  • Do not take CABOMETYX with food. Take CABOMETYX at least 1 hour before or at least 2 hours after eating.
  • Swallow CABOMETYX tablets whole.
  • Do not crush, chew or split CABOMETYX tablets.
  • If you miss a dose and your next scheduled dose is in less than 12 hours, take your next dose at the normal time. Do not make up the missed dose.

What should I avoid while taking CABOMETYX?

Avoid drinking grapefruit juice, eating grapefruit or taking supplements that contain grapefruit or St. John’s wort during treatment with CABOMETYX.

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. Get emergency help right away if you get:

    • swelling or pain in your arms or legs
    • shortness of breath
    • feel lightheaded or faint
    • sweating more than usual
    • numbness or weakness of your face, arm or leg, especially on one side of your body
    • sudden confusion, trouble speaking or understanding
    • sudden trouble seeing in one or both eyes
    • sudden trouble walking
    • dizziness, loss of balance or coordination
    • a sudden severe headache
  • high blood pressure (hypertension). Hypertension is common with CABOMETYX and sometimes can be severe. Your healthcare provider will check your blood pressure before starting CABOMETYX and regularly during treatment with CABOMETYX. If needed, your healthcare provider may prescribe medicine to treat your high blood pressure. Tell your healthcare provider if you develop severe headaches, nose bleeds, tiredness or confusion, vision changes, chest pain, trouble breathing, irregular heartbeat, or blood in your urine.

  • heart problems. CABOMETYX can cause heart failure that may lead to death. Your healthcare provider may check your heart function before and during treatment with CABOMETYX. Tell your healthcare provider right away if you get any of the following signs and symptoms:

    • feeling like your heart is pounding, racing, or beating irregularly
    • shortness of breath
    • swelling of your ankles or feet
    • feeling lightheaded
    • tiredness
  • diarrhea. Diarrhea is common with CABOMETYX and can be severe. If needed, your healthcare provider may prescribe medicine to treat your diarrhea. Tell your healthcare provider right away if you have frequent loose, watery bowel movements.
  • a skin problem called hand-foot skin reaction. Hand-foot skin reactions are common with CABOMETYX and can be severe. Tell your healthcare provider right away if you have rashes, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.
  • liver problems. Liver problems may happen during treatment with CABOMETYX. When CABOMETYX is taken in combination with nivolumab, severe changes in liver function tests may happen more often than if you take CABOMETYX alone. Your healthcare provider will do blood tests to check your liver function before and during treatment with CABOMETYX. Tell your healthcare provider right away if you develop symptoms of liver problems including: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach-area (abdomen), dark urine, bleeding or bruising more easily than normal.
  • adrenal gland problems. Your healthcare provider will monitor you for this problem. Your healthcare provider may prescribe hormone replacement therapy or corticosteroid medicines if needed. Tell your healthcare provider right away if you develop any of the following signs or symptoms: extreme tiredness, dizziness or fainting, weakness, nausea, or vomiting.
  • protein in your urine and possible kidney problems. Symptoms may include swelling in your hands, arms, legs, or feet. Your healthcare provider will check you for this problem during treatment with CABOMETYX.
  • severe jaw bone problems (osteonecrosis). Your healthcare provider should examine your mouth before you start and during treatment with CABOMETYX. Tell your dentist that you are taking CABOMETYX. It is important for you to practice good mouth care during treatment with CABOMETYX. Tell your healthcare provider right away if you develop any symptoms of jaw problems, including: jaw pain, toothache, or sores on your gums.

  • wound healing problems. Wound healing problems have happened in some people who take CABOMETYX. Tell your healthcare provider if you plan to have any surgery before or during treatment with CABOMETYX.

    • You should stop taking CABOMETYX at least 3 weeks before planned surgery.
    • Your healthcare provider should tell you when you may start taking CABOMETYX again after surgery.
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome can happen during treatment with CABOMETYX. Tell your healthcare provider right away if you have headaches, seizures, confusion, changes in vision, or problems thinking.
  • change in thyroid function. CABOMETYX can cause changes in your thyroid function, including changes to thyroid hormone levels in your blood. Your healthcare provider will do blood tests to check your thyroid function before and during treatment with CABOMETYX.

  • decreased calcium level in your blood (hypocalcemia). CABOMETYX can cause you to have a decreased amount of calcium in your blood. Your healthcare provider will do blood tests to check you for this problem and give you calcium if needed. Tell your healthcare provider right away if you get any of the following signs or symptoms:

    • muscle stiffness or muscle spasms
    • numbness or tingling in your fingers, toes, or around your mouth
    • seizures
    • sudden weight gain
    • swelling of your arms, hands, legs, and ankles

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with CABOMETYX if you have certain side effects.

The most common side effects of CABOMETYX include:

  • tiredness
  • nausea and vomiting
  • constipation
  • decreased appetite
  • weight decreased

The most common side effects of CABOMETYX when used in combination with nivolumab include:

  • tiredness
  • mouth sores
  • rash
  • low thyroid hormone levels (hypothyroidism)
  • pain in muscles, bones, and joints
  • decreased appetite
  • nausea
  • changes in the way things taste
  • stomach-area (abdominal) pain
  • cough
  • upper respiratory tract infection

CABOMETYX may cause fertility problems in females and males, which may affect your ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of CABOMETYX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store CABOMETYX?

  • Store CABOMETYX at room temperature between 68°F to 77°F (20°C to 25°C).

Keep CABOMETYX and all medicines out of the reach of children.

General information about the safe and effective use of CABOMETYX.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CABOMETYX for a condition for which it was not prescribed. Do not give CABOMETYX to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about CABOMETYX that is written for health professionals.

What are the ingredients in CABOMETYX?

Active ingredient: cabozantinib

Inactive ingredients: microcrystalline cellulose, lactose anhydrous, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, triacetin, and iron oxide yellow.

Manufactured for Exelixis, Inc. Alameda, CA 94502

For more information, go to www.cabometyx.com or call 1-855-292-3935.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 208692 · View the label on DailyMed

Revision date stated in the text: October 2025

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Cabometyx

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Kinase Inhibitor
Active ingredient Cabozantinib s-malate
Dosage form Tablet
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) EXELIXIS INC
FDA approval NDA 208692New Drug Application (NDA) Approved April 25, 2016
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
60 mg – 30 in 1 bottle NDC 42388-023-26
60 mg – 30 in 1 bottle / 1 in 1 carton NDC 42388-023-46
60 mg – 30 in 1 bottle NDC 42388-023-36
60 mg – 15 in 1 bottle NDC 42388-023-37
60 mg – 15 in 1 bottle / 1 in 1 carton NDC 42388-023-57
40 mg – 30 in 1 bottle NDC 42388-025-26
40 mg – 30 in 1 bottle / 1 in 1 carton NDC 42388-025-46
40 mg – 15 in 1 bottle NDC 42388-025-37
40 mg – 15 in 1 bottle / 1 in 1 carton NDC 42388-025-57
20 mg – 30 in 1 bottle NDC 42388-024-26
20 mg – 30 in 1 bottle / 1 in 1 carton NDC 42388-024-46
20 mg – 15 in 1 bottle NDC 42388-024-37
Show more packages (1)+
20 mg – 15 in 1 bottle / 1 in 1 carton NDC 42388-024-57

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.