Cometriq Side Effects

Generic name: cabozantinib

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

Some side effects of Cometriq may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to cabozantinib: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking cabozantinib (the active ingredient contained in Cometriq) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people taking cabozantinib have developed a perforation (a hole or tear) or a fistula (an abnormal passageway) within the stomach or intestines. Call your doctor if you have severe stomach pain, or if you feel like you are choking and gagging when you eat or drink.

Stop using cabozantinib and call your doctor at once if you have:

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• heavy menstrual bleeding, or any other bleeding that will not stop;

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• change in mental status, seizure (convulsions);

• pain, swelling, warmth, or redness in one or both legs;

• chest pain spreading to the arm or shoulder, sudden cough, wheezing, sweating, rapid breathing;

• a light-headed feeling, like you might pass out;

• puffy eyes, swelling in your ankles or feet, weight gain, urine that looks foamy;

• dangerously high blood pressure (buzzing in your ears, anxiety, shortness of breath, uneven heartbeats); or

• jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work.

Once you have had any of the side effects listed above, you may never be able to use cabozantinib again. If you stop taking cabozantinib for any reason, talk to your doctor before you start taking the medication again.

Also call your doctor at once if you have any of these other side effects:

• severe or ongoing vomiting or diarrhea;

• a wound that will not heal;

• pain, tenderness, redness, swelling, blistering, or peeling skin on the palms of your hands or the soles of your feet;

• severe mouth pain that interferes with eating or drinking;

• fever, flu symptoms, easy bruising;

• dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• numbness or tingly feeling around your mouth, muscle tightness or contraction, overactive reflexes.

Common side effects may include:

• nausea, diarrhea, constipation;

• mild mouth discomfort, changes in your sense of taste;

• feeling weak or tired, decrease in appetite or weight; or

• hoarseness in your voice, changes in your hair color.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to cabozantinib: oral capsule

General

Fatal adverse reactions occurred in 6% of patients resulting from hemorrhage, pneumonia, septicemia, fistulas, cardiac arrest, respiratory failure, and unspecified death.

The most frequent adverse reactions leading to discontinuation in treatment include hypocalcemia, increased lipase, palmar-plantar erythrodysesthesia syndrome (PPES), diarrhea, fatigue, hypertension, nausea, pancreatitis, tracheal fistula formation, and vomiting.

Cardiovascular

Very common (10% or more): Hypertension (33%)
Common (1% to 10%): Hypotension (7%)

Dermatologic

Very common (10% or more): PPES (50%), hair color changes/depigmentation, graying (34%), rash (19%), dry skin (19%), alopecia (16%), erythema (11%)
Common (1% to 10%): Hyperkeratosis (7%)

Gastrointestinal

Very common (10% or more): Diarrhea (63%), stomatitis (51%; includes aphthous stomatitis, mouth ulcerations, and mucosal inflammation), nausea (43%), oral pain (36%; includes oropharyngeal pain, glossitis, burning mouth syndrome, and glossodynia), abdominal pain (27%; includes lower and upper abdominal pain, abdominal rigidity and tenderness, and esophageal pain, constipation (27%), vomiting (24%), dysphagia (13%), dyspepsia (11%)
Common (1% to 10%): Hemorrhoids (9%)

Hematologic

Very common (10% or more): Lymphopenia (53%), neutropenia (35%), thrombocytopenia (35%)

Metabolic

Very common (10% or more): Decreased weight (48%), decreased appetite (46%)
Common (1% to 10%): Dehydration (7%)

Musculoskeletal

Very common (10% or more): Arthralgia (14%), muscle spasms (12%)
Common (1% to 10%): Musculoskeletal chest pain (9%)

Nervous system

Very common (10% or more): Fatigue (41%), dysgeusia (34%), asthenia (21%), headache (18%), dizziness (14%)
Common (1% to 10%): Paresthesia (7%), peripheral sensory neuropathy (7%), peripheral neuropathy (5%)

Other

Laboratory abnormalities:
Very common (10% or more): Increased AST (86%), increased ALT (86%), increased ALP (52%), hypocalcemia (52%), hypophosphatemia (28%), hyperbilirubinemia (25%). hypomagnesemia (19%), hypokalemia (18%), hyponatremia (10%), increased thyroid stimulating hormone (TSH)

Psychiatric

Common (1% to 10%): Anxiety (9%)

Respiratory

Very common (10% or more): Dysphonia (20%)

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