Sunitinib (Sutent) - Uses, Side Effects, and More

What are the most common side effects of sunitinib?

The most common side effects of sunitinib are listed below. Tell your health care provider if you have any of these side effects that bother you.

• Feeling unusually weak or tired
• Diarrhea
• Mouth sores
• Nausea and vomiting
• Upset stomach or stomach pain
• Blisters or rash on the palms of your hands and soles of your feet
• Increased blood pressure (see below)
• Bleeding
• Taste changes

There may be other side effects of sunitinib 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. 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 sunitinib?

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

Severe Allergic Reactions. Sunitinib may cause allergic reactions, which can be serious. Stop taking sunitinib 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, skin rash, or pale red bumps on the skin called hives
• Nausea or vomiting
• Dizziness, feeling lightheaded, or fainting
• Stomach cramps
• Joint pain

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking sunitinib. 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)

Heart Failure. Sunitinib may increase your risk of heart failure. 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

Heart Attack. Sunitinib can increase your risk of a heart attack that can lead to death. Get emergency help if you have any of the following symptoms of a heart attack.

• Chest pain or pressure
• Fast or abnormal heartbeat
• Trouble breathing
• Pain in your back, jaw, throat, or arm
• Sweating, upset stomach, vomiting, or dizziness

Heart Rhythm Changes. Sunitinib may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Tell your health care provider right away if you faint, feel dizzy, or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Increased Blood Pressure (Hypertension). Sunitinib may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your health care provider if your blood pressure increases while taking this medicine.

If you measure your blood pressure and the top number (systolic) is 180 or higher or the bottom number (diastolic) is 120 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 vision or other changes to vision
• Anxiety
• Buzzing in the ears
• Nosebleed
• Feeling of skipped heartbeats

Severe Bleeding. Sunitinib commonly causes bleeding but can increase your risk of severe bleeding that can lead to death. It can also increase your risk of bleeding, ulcers, and tears (perforation) in your gut. 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 sunitinib.

• Pink, red, or brown urine (pee)
• Vomit with blood that looks like coffee grounds
• Red or black stools (looks like tar)
• Coughing up blood or blood clots
• Stomach pain that does not go away
• Upset stomach
• Feel faint
• Headache or change in your mental status

Tumor Lysis Syndrome. Sunitinib can cause a fast breakdown of cancer cells. This can lead to a condition called tumor lysis syndrome, which can be serious. It is important to drink plenty of water while receiving sunitinib and to keep all appointments for blood work so your health care provider can see how your body is responding to sunitinib. Tell your health care provider right away if you have any of the following signs of tumor lysis syndrome while taking sunitinib.

• Nausea and vomiting
• Weakness
• Swelling or fluid retention
• Shortness of breath
• Muscle cramps
• Seizures

Small Blood Vessel Injury and Blood Clots. Sunitinib may cause thrombotic microangiopathy, such as hemolytic uremic syndrome or thrombotic thrombocytopenic purpura (TTP). You may have problems with your blood clotting or serious damage to your organs like your kidneys and brain. The conditions need to be treated right away in the hospital, or they can lead to death. Get emergency help if you have any of the following symptoms without another explanation.

• Fever
• Shortness of breath
• Pale or yellowish skin
• Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
• Changes in your vision
• Unusual weakness or tiredness
• Headache, confusion, or slurred speech
• Fast heartbeat
• Purplish spots (purpura) on the skin or in the mouth due to bleeding under the skin
• Low amount of pee or pee that is pink or has blood in it

Protein in Urine. Sunitinib can cause a high amount of protein in urine (proteinuria), which can be a sign of kidney damage and can be serious or a sign of life-threatening kidney failure. Tell your health care provider if you have the following symptoms of protein in your urine.

• Foamy or bubbly pee
• Swelling in your hands, feet, belly, or face
• Peeing more often than usual
• Shortness of breath
• Tiredness
• Loss of appetite

Severe Skin Reactions. Sunitinib can cause severe skin reactions, called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), that can lead to death if not treated. If you develop a rash, stop sunitinib and call your health care provider right away. Get emergency help if you have any of the following symptoms of SJS or TEN.

• Painful red or purple skin that looks burned and peels off
• Flat red rash or blisters on your skin, mouth, nose, and genitals
• Red, painful, watery eyes
• Flu-like symptoms including fever, chills, and muscle aches

Necrotizing Fasciitis (Fournier’s Gangrene). Sunitinib can cause necrotizing fasciitis, which is an aggressive skin and tissue infection that causes some of the tissue involved to die. Necrotizing fasciitis is rare but very serious, can lead to death, and may require surgery to treat it. Get help right away if you have any of the following symptoms of this serious infection.

• Pain, redness, tenderness, or swelling of the perineum (the area between the anus and genitals)
• Fever
• General feeling of illness or discomfort

Posterior Reversible Encephalopathy Syndrome (PRES). Sunitinib 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

Thyroid Problems. Sunitinib can cause the function of your thyroid gland to change, which can lead to low thyroid levels (hypothyroidism) or high thyroid levels (hyperthyroidism). Keep all appointments to have your blood checked. Tell your health care provider if you have any of the following signs of thyroid problems.

• Weight gain or weight loss
• Feeling cold
• Tiredness that does not go away or continues to worsen
• Constipation
• Feeling nervous or anxious
• Mood swings or feeling cranky
• Fast heartbeat or a change in your heartbeat
• Increased hunger
• Sweating

Low Blood Sugar (Hypoglycemia). Sunitinib can cause low blood sugar, which can be serious and may lead to death. You may need to check your blood sugar more often if you have changes to your diet, exercise regimen, or medicines for diabetes. Do not use sunitinib and call your health care provider right away if you have any of the following symptoms of hypoglycemia.

• Headache
• Crankiness or anxiety
• Hunger
• Dizziness or confusion
• Blurry vision
• Slurred speech
• Sweating
• Feeling jittery or shakiness
• Fast heartbeat
• Seizures

Severe Jawbone Problems (Osteonecrosis). Sunitinib 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 sunitinib 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

Wound Healing Issues. Sunitinib can make it difficult 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 sunitinib.