SUTENT® What are possible side effects of SUTENT?

(sunitinib malate)

What are possible side effects of SUTENT?

  • See "What is the most important information I should know about SUTENT?"
  • Heart problems. Heart problems may include heart failure, heart attack and heart muscle problems (cardiomyopathy) that can lead to death. Tell your healthcare provider if you feel very tired, are short of breath, or have swollen feet and ankles.
  • Abnormal heart rhythm changes. Changes in the electrical activity of your heart called QT prolongation can cause irregular heart beats that can be life threatening. Your healthcare provider may do electrocardiograms and blood tests (electrolytes) to watch for these problems during your treatment with SUTENT. Tell your healthcare provider right away if you feel dizzy, faint, or have abnormal heartbeats during your treatment with SUTENT
  • you feel faint or lightheaded, or you pass out
  • dizziness
  • feel your heart beat is irregular or fast
  • High blood pressure. High blood pressure is common with SUTENT and may sometimes be severe. Follow your healthcare provider's instructions about having your blood pressure checked regularly. Call your healthcare provider if your blood pressure is high, or if you have any of the following signs or symptoms of high blood pressure:
  • severe headache
  • lightheadedness
  • dizziness
  • change in vision
Your healthcare provider may prescribe medicine for you to treat high blood pressure, if needed.
  • Bleeding problems. Bleeding is common with SUTENT, but SUTENT can also cause severe bleeding problems that can lead to death. Your healthcare provider will monitor you for bleeding and may do blood tests if needed. Call your healthcare provider right away if you have any of these symptoms or a serious bleeding problem during treatment with SUTENT, including:
  • painful, swollen stomach (abdomen)
  • vomiting blood
  • coughing up blood
  • black, sticky stools
  • bloody urine
  • headache
  • change in your mental status
  • Serious stomach and intestinal problems, that can sometimes lead to death. Some people have had tears in their stomach or intestine (perforation), or have developed an abnormal opening between the stomach and intestine (fistula). Get medical help right away if you get stomach-area (abdominal) pain that does not go away or is severe during treatment with SUTENT.
  • Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells and may lead to death. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.
  • Abnormal changes in the brain (Reversible Posterior Leukoencephalopathy Syndrome [RPLS]). RPLS can cause a collection of symptoms including headache, confusion, and vision loss. Some people who have taken SUTENT have developed RPLS that can lead to death.
  • Thrombotic microangiopathy (TMA) including thrombotic thrombocytopenia purpura (TTP) and hemolytic uremic syndrome (HUS). TMA is a condition that involves injury to the smallest blood vessels, and blood clots that can happen while taking SUTENT. TMA is accompanied by a decrease in red cells and cells that are involved with clotting. TMA may harm your body's organs such as the brain and kidneys, and can sometimes lead to death.
  • Protein in your urine. Some people who have taken SUTENT have developed protein in their urine, and in some cases, kidney problems that can lead to death. Your healthcare provider will check you for this problem.
  • Serious skin and mouth reactions. Treatment with SUTENT has caused severe skin reactions that can lead to death, including:
    • severe rash with blisters or peeling of the skin.
    • painful sores or ulcers on the skin, lips or inside the mouth.
    • tissue damage (necrotizing fasciitis).
    If you have any signs or symptoms of severe skin reactions, stop taking SUTENT and call your healthcare provider or get medical help right away.
  • Thyroid problems. Your healthcare provider may do tests to check your thyroid function during SUTENT treatment. Tell your healthcare provider if you have any of the following signs and symptoms during your treatment with SUTENT:
  • tiredness that gets worse and does not go away
  • loss of appetite
  • problems with heat
  • feeling nervous or agitated, tremors
  • sweating
  • nausea or vomiting
  • diarrhea
  • fast heat rate
  • weight gain or weight loss
  • feeling depressed
  • irregular menstrual periods or no menstrual periods
  • headache
  • hair loss
  • Low blood sugar (hypoglycemia). Low blood sugar can happen with SUTENT, and may cause you to become unconscious, or you may need to be hospitalized. Low blood sugar with SUTENT may be worse in people who have diabetes and take antidiabetic medicines. Your healthcare provider should check your blood sugar levels regularly during treatment with SUTENT and may need to adjust the dose of your antidiabetic medicines. Call your healthcare provider right away if you have any of the following signs or symptoms of low blood sugar during your treatment with SUTENT:
  • headache
  • drowsiness
  • weakness
  • dizziness
  • confusion
  • irritability
  • hunger
  • fast heart beat
  • sweating
  • feeling jittery
  • Jawbone problems (osteonecrosis). Severe jawbone problems have happened in some people who take SUTENT. Certain risk factors such as taking a bisphosphonate medicine or having dental disease may increase your risk of getting osteonecrosis. Your healthcare provider may tell you to see your dentist before you start taking SUTENT. Your healthcare provider may tell you to avoid dental procedures, if possible, during your treatment with SUTENT, especially if you are receiving a bisphosphonate medicine into a vein (intravenous). Tell your healthcare provider if you plan to have any dental procedures before or during treatment with SUTENT.
    • You should stop taking SUTENT at least 3 weeks before planned dental procedures.
    • Your healthcare provider should tell you when you may start taking SUTENT again after dental procedures.
  • Wound healing problems. Wound healing problems have happened in some people who take SUTENT. Tell your healthcare provider if you plan to have any surgery before or during treatment with SUTENT.
    • You should stop taking SUTENT at least 3 weeks before planned surgery.
    • Your healthcare provider should tell you when you may start taking SUTENT again after surgery.
Your healthcare provider may temporarily stop, reduce your dose, or permanently stop treatment with SUTENT if you develop serious side effects.
Common side effects of SUTENT include:
  • tiredness
  • weakness
  • diarrhea
  • pain, swelling or sores inside of your mouth
  • nausea
  • loss of appetite
  • indigestion
  • vomiting
  • stomach-area (abdominal) pain
  • blisters or rash on the palms of your hands and soles of your feet
  • high blood pressure
  • taste changes
  • low platelet counts
The medicine in SUTENT is yellow, and it may make your skin look yellow. Your skin and hair may get lighter in color. SUTENT may also cause other skin problems including: dryness, thickness or cracking of the skin.
These are not all of the possible side effects of SUTENT.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Find SUTENT® medical information:

Find SUTENT® medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

SUTENT® Quick Finder

Medication Guide

Health Professional Information

What are possible side effects of SUTENT?

What are possible side effects of SUTENT?

  • See "What is the most important information I should know about SUTENT?"
  • Heart problems. Heart problems may include heart failure, heart attack and heart muscle problems (cardiomyopathy) that can lead to death. Tell your healthcare provider if you feel very tired, are short of breath, or have swollen feet and ankles.
  • Abnormal heart rhythm changes. Changes in the electrical activity of your heart called QT prolongation can cause irregular heart beats that can be life threatening. Your healthcare provider may do electrocardiograms and blood tests (electrolytes) to watch for these problems during your treatment with SUTENT. Tell your healthcare provider right away if you feel dizzy, faint, or have abnormal heartbeats during your treatment with SUTENT
  • you feel faint or lightheaded, or you pass out
  • dizziness
  • feel your heart beat is irregular or fast
  • High blood pressure. High blood pressure is common with SUTENT and may sometimes be severe. Follow your healthcare provider's instructions about having your blood pressure checked regularly. Call your healthcare provider if your blood pressure is high, or if you have any of the following signs or symptoms of high blood pressure:
  • severe headache
  • lightheadedness
  • dizziness
  • change in vision
Your healthcare provider may prescribe medicine for you to treat high blood pressure, if needed.
  • Bleeding problems. Bleeding is common with SUTENT, but SUTENT can also cause severe bleeding problems that can lead to death. Your healthcare provider will monitor you for bleeding and may do blood tests if needed. Call your healthcare provider right away if you have any of these symptoms or a serious bleeding problem during treatment with SUTENT, including:
  • painful, swollen stomach (abdomen)
  • vomiting blood
  • coughing up blood
  • black, sticky stools
  • bloody urine
  • headache
  • change in your mental status
  • Serious stomach and intestinal problems, that can sometimes lead to death. Some people have had tears in their stomach or intestine (perforation), or have developed an abnormal opening between the stomach and intestine (fistula). Get medical help right away if you get stomach-area (abdominal) pain that does not go away or is severe during treatment with SUTENT.
  • Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells and may lead to death. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.
  • Abnormal changes in the brain (Reversible Posterior Leukoencephalopathy Syndrome [RPLS]). RPLS can cause a collection of symptoms including headache, confusion, and vision loss. Some people who have taken SUTENT have developed RPLS that can lead to death.
  • Thrombotic microangiopathy (TMA) including thrombotic thrombocytopenia purpura (TTP) and hemolytic uremic syndrome (HUS). TMA is a condition that involves injury to the smallest blood vessels, and blood clots that can happen while taking SUTENT. TMA is accompanied by a decrease in red cells and cells that are involved with clotting. TMA may harm your body's organs such as the brain and kidneys, and can sometimes lead to death.
  • Protein in your urine. Some people who have taken SUTENT have developed protein in their urine, and in some cases, kidney problems that can lead to death. Your healthcare provider will check you for this problem.
  • Serious skin and mouth reactions. Treatment with SUTENT has caused severe skin reactions that can lead to death, including:
    • severe rash with blisters or peeling of the skin.
    • painful sores or ulcers on the skin, lips or inside the mouth.
    • tissue damage (necrotizing fasciitis).
    If you have any signs or symptoms of severe skin reactions, stop taking SUTENT and call your healthcare provider or get medical help right away.
  • Thyroid problems. Your healthcare provider may do tests to check your thyroid function during SUTENT treatment. Tell your healthcare provider if you have any of the following signs and symptoms during your treatment with SUTENT:
  • tiredness that gets worse and does not go away
  • loss of appetite
  • problems with heat
  • feeling nervous or agitated, tremors
  • sweating
  • nausea or vomiting
  • diarrhea
  • fast heat rate
  • weight gain or weight loss
  • feeling depressed
  • irregular menstrual periods or no menstrual periods
  • headache
  • hair loss
  • Low blood sugar (hypoglycemia). Low blood sugar can happen with SUTENT, and may cause you to become unconscious, or you may need to be hospitalized. Low blood sugar with SUTENT may be worse in people who have diabetes and take antidiabetic medicines. Your healthcare provider should check your blood sugar levels regularly during treatment with SUTENT and may need to adjust the dose of your antidiabetic medicines. Call your healthcare provider right away if you have any of the following signs or symptoms of low blood sugar during your treatment with SUTENT:
  • headache
  • drowsiness
  • weakness
  • dizziness
  • confusion
  • irritability
  • hunger
  • fast heart beat
  • sweating
  • feeling jittery
  • Jawbone problems (osteonecrosis). Severe jawbone problems have happened in some people who take SUTENT. Certain risk factors such as taking a bisphosphonate medicine or having dental disease may increase your risk of getting osteonecrosis. Your healthcare provider may tell you to see your dentist before you start taking SUTENT. Your healthcare provider may tell you to avoid dental procedures, if possible, during your treatment with SUTENT, especially if you are receiving a bisphosphonate medicine into a vein (intravenous). Tell your healthcare provider if you plan to have any dental procedures before or during treatment with SUTENT.
    • You should stop taking SUTENT at least 3 weeks before planned dental procedures.
    • Your healthcare provider should tell you when you may start taking SUTENT again after dental procedures.
  • Wound healing problems. Wound healing problems have happened in some people who take SUTENT. Tell your healthcare provider if you plan to have any surgery before or during treatment with SUTENT.
    • You should stop taking SUTENT at least 3 weeks before planned surgery.
    • Your healthcare provider should tell you when you may start taking SUTENT again after surgery.
Your healthcare provider may temporarily stop, reduce your dose, or permanently stop treatment with SUTENT if you develop serious side effects.
Common side effects of SUTENT include:
  • tiredness
  • weakness
  • diarrhea
  • pain, swelling or sores inside of your mouth
  • nausea
  • loss of appetite
  • indigestion
  • vomiting
  • stomach-area (abdominal) pain
  • blisters or rash on the palms of your hands and soles of your feet
  • high blood pressure
  • taste changes
  • low platelet counts
The medicine in SUTENT is yellow, and it may make your skin look yellow. Your skin and hair may get lighter in color. SUTENT may also cause other skin problems including: dryness, thickness or cracking of the skin.
These are not all of the possible side effects of SUTENT.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Prescribing Information
Download Prescribing Information

Health Professional Information

What are possible side effects of SUTENT?

What are possible side effects of SUTENT?

  • See "What is the most important information I should know about SUTENT?"
  • Heart problems. Heart problems may include heart failure, heart attack and heart muscle problems (cardiomyopathy) that can lead to death. Tell your healthcare provider if you feel very tired, are short of breath, or have swollen feet and ankles.
  • Abnormal heart rhythm changes. Changes in the electrical activity of your heart called QT prolongation can cause irregular heart beats that can be life threatening. Your healthcare provider may do electrocardiograms and blood tests (electrolytes) to watch for these problems during your treatment with SUTENT. Tell your healthcare provider right away if you feel dizzy, faint, or have abnormal heartbeats during your treatment with SUTENT
  • you feel faint or lightheaded, or you pass out
  • dizziness
  • feel your heart beat is irregular or fast
  • High blood pressure. High blood pressure is common with SUTENT and may sometimes be severe. Follow your healthcare provider's instructions about having your blood pressure checked regularly. Call your healthcare provider if your blood pressure is high, or if you have any of the following signs or symptoms of high blood pressure:
  • severe headache
  • lightheadedness
  • dizziness
  • change in vision
Your healthcare provider may prescribe medicine for you to treat high blood pressure, if needed.
  • Bleeding problems. Bleeding is common with SUTENT, but SUTENT can also cause severe bleeding problems that can lead to death. Your healthcare provider will monitor you for bleeding and may do blood tests if needed. Call your healthcare provider right away if you have any of these symptoms or a serious bleeding problem during treatment with SUTENT, including:
  • painful, swollen stomach (abdomen)
  • vomiting blood
  • coughing up blood
  • black, sticky stools
  • bloody urine
  • headache
  • change in your mental status
  • Serious stomach and intestinal problems, that can sometimes lead to death. Some people have had tears in their stomach or intestine (perforation), or have developed an abnormal opening between the stomach and intestine (fistula). Get medical help right away if you get stomach-area (abdominal) pain that does not go away or is severe during treatment with SUTENT.
  • Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells and may lead to death. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.
  • Abnormal changes in the brain (Reversible Posterior Leukoencephalopathy Syndrome [RPLS]). RPLS can cause a collection of symptoms including headache, confusion, and vision loss. Some people who have taken SUTENT have developed RPLS that can lead to death.
  • Thrombotic microangiopathy (TMA) including thrombotic thrombocytopenia purpura (TTP) and hemolytic uremic syndrome (HUS). TMA is a condition that involves injury to the smallest blood vessels, and blood clots that can happen while taking SUTENT. TMA is accompanied by a decrease in red cells and cells that are involved with clotting. TMA may harm your body's organs such as the brain and kidneys, and can sometimes lead to death.
  • Protein in your urine. Some people who have taken SUTENT have developed protein in their urine, and in some cases, kidney problems that can lead to death. Your healthcare provider will check you for this problem.
  • Serious skin and mouth reactions. Treatment with SUTENT has caused severe skin reactions that can lead to death, including:
    • severe rash with blisters or peeling of the skin.
    • painful sores or ulcers on the skin, lips or inside the mouth.
    • tissue damage (necrotizing fasciitis).
    If you have any signs or symptoms of severe skin reactions, stop taking SUTENT and call your healthcare provider or get medical help right away.
  • Thyroid problems. Your healthcare provider may do tests to check your thyroid function during SUTENT treatment. Tell your healthcare provider if you have any of the following signs and symptoms during your treatment with SUTENT:
  • tiredness that gets worse and does not go away
  • loss of appetite
  • problems with heat
  • feeling nervous or agitated, tremors
  • sweating
  • nausea or vomiting
  • diarrhea
  • fast heat rate
  • weight gain or weight loss
  • feeling depressed
  • irregular menstrual periods or no menstrual periods
  • headache
  • hair loss
  • Low blood sugar (hypoglycemia). Low blood sugar can happen with SUTENT, and may cause you to become unconscious, or you may need to be hospitalized. Low blood sugar with SUTENT may be worse in people who have diabetes and take antidiabetic medicines. Your healthcare provider should check your blood sugar levels regularly during treatment with SUTENT and may need to adjust the dose of your antidiabetic medicines. Call your healthcare provider right away if you have any of the following signs or symptoms of low blood sugar during your treatment with SUTENT:
  • headache
  • drowsiness
  • weakness
  • dizziness
  • confusion
  • irritability
  • hunger
  • fast heart beat
  • sweating
  • feeling jittery
  • Jawbone problems (osteonecrosis). Severe jawbone problems have happened in some people who take SUTENT. Certain risk factors such as taking a bisphosphonate medicine or having dental disease may increase your risk of getting osteonecrosis. Your healthcare provider may tell you to see your dentist before you start taking SUTENT. Your healthcare provider may tell you to avoid dental procedures, if possible, during your treatment with SUTENT, especially if you are receiving a bisphosphonate medicine into a vein (intravenous). Tell your healthcare provider if you plan to have any dental procedures before or during treatment with SUTENT.
    • You should stop taking SUTENT at least 3 weeks before planned dental procedures.
    • Your healthcare provider should tell you when you may start taking SUTENT again after dental procedures.
  • Wound healing problems. Wound healing problems have happened in some people who take SUTENT. Tell your healthcare provider if you plan to have any surgery before or during treatment with SUTENT.
    • You should stop taking SUTENT at least 3 weeks before planned surgery.
    • Your healthcare provider should tell you when you may start taking SUTENT again after surgery.
Your healthcare provider may temporarily stop, reduce your dose, or permanently stop treatment with SUTENT if you develop serious side effects.
Common side effects of SUTENT include:
  • tiredness
  • weakness
  • diarrhea
  • pain, swelling or sores inside of your mouth
  • nausea
  • loss of appetite
  • indigestion
  • vomiting
  • stomach-area (abdominal) pain
  • blisters or rash on the palms of your hands and soles of your feet
  • high blood pressure
  • taste changes
  • low platelet counts
The medicine in SUTENT is yellow, and it may make your skin look yellow. Your skin and hair may get lighter in color. SUTENT may also cause other skin problems including: dryness, thickness or cracking of the skin.
These are not all of the possible side effects of SUTENT.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Contact Medical Information.9AM-5PM ET Monday to Friday; excluding holidays.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.