Note: This document contains side effect information about cabozantinib. Some dosage forms listed on this page may not apply to the brand name Cabometyx.

Applies to cabozantinib: oral capsule, oral tablet.

Serious side effects of Cabometyx

Along with its needed effects, cabozantinib (the active ingredient contained in Cabometyx) 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

• 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

• 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

• Disturbed color perception
• double vision
• halos around lights
• night blindness
• overbright appearance of lights
• tunnel vision

Other side effects of Cabometyx

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

• 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.

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]

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]

General

Patients should be closely monitored for the first 8 weeks as most adverse events have occurred early in the course of treatment.

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]