Cabozantinib Side Effects
Applies to cabozantinib: oral capsule, oral tablet.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, you doctor may do tests to make sure you are not pregnant before starting treatment. You should continue to use birth control during treatment with this medicine and for at least 4 months after the last dose to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Check with your doctor right away if you have severe stomach pain, gagging, coughing, or choking when you eat or drink. These could be symptoms of a perforation (tear) or fistula (hole) in the bowel.
This medicine may increase your risk of bleeding. Tell your doctor right away if you cough up blood or have bleeding gums, difficulty with breathing or swallowing, dizziness, increased menstrual flow or vaginal bleeding, nosebleeds, prolonged bleeding from cuts, red or dark brown urine, or red or black, tarry stools. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
This medicine may increase your risk of developing blood clots. Check with your doctor right away if you have swelling and pain in your arms, legs, or stomach, chest pain, difficulty with breathing, loss of sensation, confusion, or problems with muscle control or speech.
Check with your doctor right away if you have chest pain or discomfort, nausea, pain or discomfort in your arms, jaw, back, or neck, sweating, or vomiting. These could be symptoms of a heart attack.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine at least 3 weeks before having surgery, including dental procedures. Wait for at least 2 weeks after major surgery, or until adequate wound healing before taking this medicine again.
Your doctor will check your blood pressure on a regular basis while you are using this medicine. You might need to monitor your blood pressure at home. Tell your doctor right away if you have a severe headache, lightheadedness, or changes in your vision.
Tell your doctor right away if you have jaw tightness, swelling, numbness, pain, or a loose tooth. This could be symptoms of a severe jaw problem.
This medicine may cause a serious skin problem called hand-foot syndrome or palmar plantar erythrodysesthesia syndrome. Check with your doctor if you have a rash that does not go away or redness, pain, swelling, or blisters on the palms of your hands or soles of your feet.
Check with your doctor right away if you have dark urine, clay-colored stools, stomach pain, or yellow eyes or skin. These may be symptoms of a serious liver problem.
This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
Check with your doctor right away if you have a headache, seizures, confusion, blurred vision or other visual problems. These may be symptoms of a rare and serious brain condition called reversible posterior leukoencephalopathy syndrome.
This medicine may cause proteinuria (protein in the urine) and kidney problems. Check with your doctor right away if you have cloudy or bloody urine, high blood pressure, or swelling of the face, feet, or lower legs.
This medicine may cause hypocalcemia (low calcium in the blood). Check with your doctor right away if you have confusion, difficulty in breathing, irregular heartbeats, mood or mental changes, muscle cramps in the hands, arms, feet, or face, numbness and tingling around the mouth, fingertips, or feet, seizures, stomach cramps, tremor, or trouble breathing. Your doctor may give you calcium supplements if needed.
Talk with your doctor before using this medicine if you plan to have children. Some men and women who use this medicine have become infertile (unable to have children).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Serious side effects of cabozantinib
Along with its needed effects, cabozantinib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking cabozantinib:
More common side effects
- blurred vision
- burning, numbness, tingling, or painful sensations
- confusion
- constipation
- dark urine
- darkening of the skin
- decreased urination
- diarrhea
- difficulty with breathing or swallowing
- dizziness
- dry mouth
- dry skin and hair
- fainting
- feeling cold
- hair loss
- headache
- hoarseness or husky voice
- increase in heart rate
- lightheadedness
- loss of appetite
- mental depression
- muscle cramps, spasms, and stiffness
- nausea or vomiting
- nervousness
- pain in the chest, groin, or legs, especially the calves
- pounding in the ears
- rapid breathing
- redness, swelling, or pain of the skin
- scaling of the skin on the hands and feet
- severe, sudden headache
- skin rash or ulcers
- slow or fast heartbeat
- slurred speech
- stomach pain
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- sunken eyes
- thirst
- unsteadiness or awkwardness
- unusual tiredness or weakness
- vision changes
- weakness in the arms, hands, legs, or feet
- weight gain
- wrinkled skin
- yellow eyes or skin
Less common side effects
- bleeding gums
- bloody, black, or tarry stools
- coughing up blood
- heartburn
- heavy jaw feeling
- increased menstrual flow or vaginal bleeding
- indigestion
- loosening of a tooth
- mood or mental changes
- muscle cramps in the hands, arms, feet, legs, or face
- nosebleeds
- numbness and tingling around the mouth, fingertips, or feet
- pain, swelling, or numbness in the mouth or jaw
- paralysis
- prolonged bleeding from cuts
- red or dark brown urine
- seizures
- severe stomach pain, cramping, or burning
- tremor
- trouble breathing
- vomiting of material that looks like coffee grounds, severe and continuing
Rare side effects
- disturbed color perception
- double vision
- halos around lights
- night blindness
- overbright appearance of lights
- tunnel vision
Incidence not known
- cloudy or bloody urine
- high blood pressure
- swelling of the face, feet, or lower legs
Other side effects of cabozantinib
Some side effects of cabozantinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- belching
- bleeding after defecation
- change in taste
- changes in hair color
- decreased appetite
- decreased weight
- difficulty having a bowel movement
- difficulty with moving
- fear
- lack or loss of strength
- loss of taste
- muscle pain
- pain in the joints
- rash
- sore throat
- stomach discomfort, upset, or pain
- swelling or inflammation of the mouth
- uncomfortable swelling around the anus
- voice changes
For healthcare professionals
Applies to cabozantinib: oral capsule, oral tablet.
General adverse events
Patients should be closely monitored for the first 8 weeks as most adverse events have occurred early in the course of treatment.
Hepatic
- Very common (10% or more): Increased ALT (up to 86%), increased AST (up to 86%), increased alkaline phosphatase (up to 52%), hyperbilirubinemia (up to 25%)
- Common (1% to 10%): Cholelithiasis
- Uncommon (0.1% to 1%): Hepatic encephalopathy[Ref]
Gastrointestinal
- Very common (10% or more): Diarrhea (up to 63%), stomatitis (up to 51%), nausea (up to 43%), oral pain (up to 36%), constipation (up to 27%), abdominal pain (up to 27%), vomiting (up to 24%), dysphagia (up to 13%), dyspepsia (up to 11%), glossodynia
- Common (1% to 10%): Hemorrhoids, GI perforation, GI fistula, GI hemorrhage, pancreatitis, anal fissure, anal inflammation, cheilitis
- Uncommon (0.1% to 1%): Esophagitis[Ref]
Endocrine
- Very common (10% or more): Increased blood thyroid stimulating hormone (up to 57%)
- Common (1% to 10%): Hypothyroidism, adrenal insufficiency
- Uncommon (0.1% to 1%): Amenorrhea[Ref]
Hematologic
- Very common (10% or more): Lymphopenia (up to 53%), neutropenia (up to 35%), thrombocytopenia (up to 35%)
- Uncommon (0.1% to 1%): Increased eosinophil count, increased platelet count
- Postmarketing reports: Arterial (including aortic) aneurysms, dissections, and rupture[Ref]
Dermatologic
- Very common (10% or more): Palmar-plantar erythrodysesthesia syndrome (up to 50%), hair color changes/depigmentation/graying (up to 34%), rash (up to 19%), dry skin (up to 19%), alopecia (up to 16%), erythema (up to 11%)
- Common (1% to 10%): Hyperkeratosis, folliculitis, acne, blister, abnormal hair growth, skin exfoliation, skin hypopigmentation
- Uncommon (0.1% to 1%): Skin ulcer, telangiectasia[Ref]
Metabolic
- Very common (10% or more): Decreased weight (up to 48%), decreased appetite (up to 46%), hypocalcemia (up to 52%), hypophosphatemia (up to 28%), hypomagnesemia (up to 19%), hypokalemia (up to 18%), hyponatremia (up to 10%), increased blood lactate dehydrogenase, increased blood creatinine phosphokinase
- Common (1% to 10%): Dehydration, hypoalbuminemia[Ref]
Other
- Very common (10% or more): Fatigue (up to 41%), asthenia (up to 21%), mucosal inflammation
- Common (1% to 10%): Abscess (including visceral, intra-abdominal, skin, tooth), fungal infection (including skin, oral, genital), ear pain, tinnitus, pallor, peripheral coldness, impaired wound healing/wound complications, chills, face edema
- Uncommon (0.1% to 1%): Aspergilloma, hypoacusis, cyst, facial pain, localized edema
- Frequency not reported: Hemorrhage[Ref]
Nervous system
- Very common (10% or more): Dysgeusia (up to 34%), headache (up to 18%), dizziness (up to 14%)
- Common (1% to 10%): Paresthesia, peripheral sensory neuropathy, peripheral neuropathy, ageusia, tremor
- Uncommon (0.1% to 1%): Reversible posterior leukoencephalopathy syndrome, ataxia, attention disturbance, loss of consciousness, speech disorder, transient ischemic attack[Ref]
Musculoskeletal
- Very common (10% or more): Arthralgia (up to 14%), muscle spasms (up to 12%)
- Common (1% to 10%): Musculoskeletal chest pain, osteonecrosis of the jaw (ONJ)
- Uncommon (0.1% to 1%): Rhabdomyolysis[Ref]
Cardiovascular
- Very common (10% or more): Elevated blood pressure (up to 96%), hypertension (up to 61%)
- Common (1% to 10%): Hypotension, venous thromboembolism, arterial thromboembolism, atrial fibrillation
- Uncommon (0.1% to 1%): Angina pectoris, supraventricular tachycardia, shortened activated partial thromboplastin time
- Frequency not reported: QT interval prolongation[Ref]
Genitourinary
- Common (1% to 10%): Proteinuria, dysuria, hematuria
- Uncommon (0.1% to 1%): Vaginal hemorrhage[Ref]
Ocular
- Common (1% to 10%): Blurred vision
- Uncommon (0.1% to 1%): Cataract, conjunctivitis[Ref]
Psychiatric
- Common (1% to 10%): Anxiety, depression, confusional state
- Uncommon (0.1% to 1%): Abnormal dreams, delirium[Ref]
Respiratory
- Very common (10% or more): Dysphonia (up to 20%), oropharyngeal pain
- Common (1% to 10%): Non-GI fistula (including tracheal, pneumomediastinum, tracheo-esophageal), pulmonary embolism, respiratory tract hemorrhage (including pulmonary, bronchial, tracheal), pneumonia, pneumonia aspiration
- Uncommon (0.1% to 1%): Atelectasis, pharyngeal edema, pneumonitis[Ref]
Renal
- Uncommon (0.1% to 1%): Acute renal failure[Ref]
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References
1. (2012) "Product Information. Cometriq (cabozantinib)." Exelixis Inc
2. (2016) "Product Information. Cabometyx (cabozantinib)." Exelixis Inc
Frequently asked questions
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Further information
Cabozantinib side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.