Omcazio (Cabozantinib) - Uses, Side Effects, and More

What are the most common side effects of Omcazio?

The most common side effects of Omcazio are listed below. The specific side effects may vary depending on the condition being treated. Tell your health care provider if you have any of these side effects that bother you.

• Diarrhea (see below)
• Tiredness
• Hand-foot syndrome (see below)
• Loss of appetite
• High blood pressure (see below)
• Nausea and vomiting
• Weight loss
• Constipation

There may be other side effects of Omcazio that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Omcazio?

While less common, the most serious side effects of Omcazio are described below, along with what to do if they happen.

Severe Allergic Reactions. Omcazio may cause allergic reactions, which can be serious. Stop taking Omcazio and get help right away if you have any of the following symptoms of a serious allergic reaction.

• Breathing problems or wheezing
• Racing heart
• Fever or general ill feeling
• Swollen lymph nodes
• Swelling of the face, lips, mouth, tongue, or throat
• Trouble swallowing or throat tightness
• Itching or skin rash
• Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
• Nausea or vomiting
• Dizziness, feeling lightheaded, or fainting
• Stomach cramps
• Joint pain

Severe Bleeding. Omcazio can increase your risk of severe bleeding that can lead to death. Some people with serious bleeding may need a blood transfusion or surgery. Call your health care provider right away if you have any of the following signs of severe bleeding while taking Omcazio.

• Pink, red, or brown urine (pee)
• Vomit with blood that looks like coffee grounds
• Red or black, tarry stools (poop)
• Coughing up blood or blood clots

Stomach Bleeding. Omcazio can increase your risk of bleeding, ulcers, and tears (perforation) in your gut. Stop taking Omcazio and get emergency help if you have any of the following symptoms.

• Vomiting blood
• Black or tarry poop
• Stomach pain that does not go away
• Upset stomach
• Feeling faint

Blood Clots. Omcazio may cause blood clots in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep venous thrombosis (DVT). Stop taking Omcazio and get emergency help if you have any of the following signs of blood clots.

• Chest pain or pressure
• Fast or abnormal heartbeat
• Trouble breathing
• Pain in your back, jaw, throat, or arm
• Sweating, upset stomach, vomiting, or dizziness
• Sudden weakness on one side of your body
• Sudden and severe headache
• Slurred speech or trouble understanding speech
• Pain, swelling, or tenderness in your arm or leg
• Vision loss
• Bulging eyes
• Double vision

Heart Failure. Omcazio can cause serious heart problems, including heart failure. Your health care provider may check how well your heart is pumping before and during treatment. Tell your health care provider right away if you have any of the following symptoms of heart failure.

• Shortness of breath or trouble breathing, especially while lying down
• Swelling in your feet, ankles, or legs
• Unusually fast weight gain
• Unusual tiredness
• Chest pain or a fast or irregular heartbeat

Diarrhea. Diarrhea is common with Omcazio but can sometimes become severe. Contact your health care provider if you have diarrhea that does not improve, or if you are having a hard time drinking enough fluids. If you are given medicine to prevent or treat diarrhea, take it exactly as your health care provider tells you. Call your health care provider right away if you have any of the following.

• Severe diarrhea
• Diarrhea that does not go away
• Diarrhea with weakness, dizziness, or fever

High Blood Pressure (Hypertension).Omcazio can raise your blood pressure or make it worse if you have a history of high blood pressure. Your health care provider will check your blood pressure before and during treatment. 

If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but look out for and tell your health care provider right away if you have any of the following symptoms of severely high blood pressure.

• Sudden severe headache
• Chest pain
• Dizziness or confusion
• Trouble breathing
• Nausea or vomiting
• Blurry or other changes to vision
• Anxiety
• Buzzing in the ears
• Nosebleed
• Feeling of skipped heartbeats

Hand-Foot Syndrome. Omcazio can cause hand-foot syndrome, also called palmar-plantar erythrodysesthesia syndrome. Hand-foot syndrome can cause you to have numbness, tingling, or changes in feeling in the palms of your hands and soles of your feet. It may also cause redness, discoloration, swelling, or pain in your hands and feet. Stop taking Omcazio and call your health care provider right away if you have any of these symptoms and cannot do your usual activities.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Omcazio. The risk may be higher when Omcazio is taken in combination with another medicine called nivolumab. Keep all appointments for lab tests to check your liver health. Call your health care provider right away if you have any of the following symptoms of liver damage.

• Nausea or vomiting
• Stomach or belly pain
• Fever
• Weakness or unusual tiredness
• Itching
• Loss of appetite
• Light-colored poop
• Dark-colored urine (pee)
• Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Reduced Adrenal Function. Taking Omcazio in combination with nivolumab can cause your body’s adrenal glands to make less cortisol (the stress hormone). This is known as adrenal insufficiency. Adrenal insufficiency can worsen if your body is under stress because of fever, surgery, or trauma. Tell your health care provider if you have any of the following symptoms of adrenal insufficiency.

• Nausea and vomiting
• Weakness, tiredness, or lack of energy
• Low blood pressure

Protein in Urine. Omcazio can cause a high amount of protein in the urine, called proteinuria. If you experience high levels of protein in your urine, your health care provider may need to pause your medicine. Tell your health care provider if you have the following symptoms. 

• Foamy or bubbly pee
• Swelling in your hands, feet, belly, and face
• Peeing more often than normal
• Shortness of breath
• Tiredness
• Loss of appetite
• Nausea and vomiting
• Muscle cramps at night

Wound Healing Issues. Omcazio can make it hard for your body to heal wounds. Tell your health care provider if you have any planned or emergency surgeries or if you have any injuries that occur while taking Omcazio.

Severe Jawbone Problems (Osteonecrosis). Omcazio can rarely cause severe jawbone problems, also called osteonecrosis of the jaw. In this condition, your jawbone may get damaged due to reduced blood flow. You may be at higher risk if you are undergoing certain dental procedures (such as a tooth extraction or dental implants), have poor oral health, or have cancer or certain other conditions. You may be told to see a dentist before starting Omcazio and to practice good mouth care. Call your health care provider right away if you have any of the following symptoms of jaw osteonecrosis.

• Jaw pain or discomfort
• Mouth sores
• Loose teeth

Posterior Reversible Encephalopathy Syndrome (PRES). Omcazio may cause a rare but serious brain condition called PRES. PRES involves swelling and narrowing of blood vessels in your brain. If PRES is not treated, it can lead to a stroke. Call your health care provider right away if you have the following symptoms of PRES.

• Changes in thinking or behavior
• Confusion or hallucinations
• Sudden decrease or change in vision
• Sudden severe headache
• Seizures

Low Thyroid Hormones (Hypothyroidism). Omcazio can cause changes in how your thyroid gland works, which can lead to lower levels of thyroid hormones. Keep all appointments to have your blood checked. Tell your health care provider if you have any of the following signs of low thyroid hormones.

• Weight gain
• Feeling cold
• Tiredness that does not go away or continues to worsen
• Constipation