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Sutent Side Effects

Generic Name: sunitinib

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

In Summary

Common side effects of Sutent include: oral candidiasis, asthenia, decreased left ventricular ejection fraction, diarrhea, hypokalemia, lymphocytopenia, mucositis, neutropenia, vomiting, and hypertension. Other side effects include: severe hypertension. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to sunitinib: oral capsule

Along with its needed effects, sunitinib (the active ingredient contained in Sutent) 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 sunitinib:

More common
  • Bleeding gums
  • bloating or swelling of the face, arms, hands, fingers, lower legs, or feet
  • blurred vision
  • chest pain
  • chills
  • confusion
  • coughing up blood
  • cracked lips
  • decreased urine output and frequency
  • diarrhea
  • difficulty with breathing or swallowing
  • dilated neck veins
  • dizziness
  • dry mouth
  • extreme tiredness or weakness
  • fainting
  • fast, slow, or irregular heartbeat
  • fever
  • headache
  • increased menstrual flow or vaginal bleeding
  • irregular breathing
  • labored breathing
  • lightheadedness
  • nervousness
  • nosebleeds
  • paralysis
  • pounding in the ears
  • prolonged bleeding from cuts
  • rapid breathing
  • rapid weight gain
  • red or black, tarry stools
  • red or dark brown urine
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • sunken eyes
  • swelling or inflammation of the mouth
  • thirst
  • tightness in the chest
  • tingling of the hands or feet
  • troubled breathing
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • wrinkled skin
  • yellow eyes or skin
Less common
  • Bleeding from the rectum
  • bleeding from wounds
  • constipation
  • depressed mood
  • dry skin and hair
  • feeling cold
  • hair loss
  • hoarseness or husky voice
  • indigestion
  • loss of appetite
  • muscle cramps and stiffness
  • nausea
  • pain in the chest, groin, or legs, especially the calves
  • pain in the stomach, side, or abdomen, possibly radiating to the back
  • severe stomach pain
  • severe, sudden headache
  • slurred speech
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • vision changes
  • vomiting
  • vomiting of blood or material that looks like coffee grounds
Rare Incidence not known
  • Blistering, peeling, or loosening of the skin
  • cough
  • dark-colored urine
  • heavy feeling of the jaw
  • increased thirst
  • itching
  • joint pain, stiffness, or swelling
  • loosening of a tooth
  • lower back or side pain
  • muscle cramps or spasms
  • muscular pain, tenderness, wasting, or weakness
  • pain, swelling, or numbness in the mouth or jaw
  • painful or difficult urination
  • pale skin
  • red skin lesions, often with a purple center
  • sore throat
  • sudden, severe chest pain
  • unusual bleeding or bruising
  • weight gain

Some side effects of sunitinib 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
  • blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet
  • change in color of the treated skin
  • change in taste
  • difficulty with moving
  • discouragement
  • excess air or gas in the stomach or bowels
  • feeling of fullness
  • feeling sad or empty
  • hair color changes
  • hair loss or thinning of the hair
  • heartburn
  • irritability
  • lack of appetite
  • lack or loss of strength
  • loss of interest or pleasure
  • muscle aches or pains
  • numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet
  • pain or burning in the throat
  • passing gas
  • stomach discomfort, upset, or pain
  • swollen joints
  • trouble concentrating
  • trouble sleeping

For Healthcare Professionals

Applies to sunitinib: oral capsule


The most common side effects included fatigue, asthenia, fever, diarrhea, nausea, mucositis/stomatitis, vomiting, dyspepsia, abdominal pain, constipation, hypertension, peripheral edema, rash, hand and foot syndrome, skin discoloration, dry skin, hair color changes, altered taste, headache, back pain, arthralgia, extremity pain, cough, dyspnea, anorexia, and bleeding.

The most serious adverse reactions included hepatotoxicity, renal failure, heart failure, pulmonary embolism, gastrointestinal perforation, and hemorrhages.[Ref]


Very common (10% or more): Diarrhea (up to 66%), nausea (up to 58%), mucositis/stomatitis (up to 49%), abdominal pain (up to 44%), vomiting (up to 39%), dyspepsia (up to 34%), constipation (up to 28%), dry mouth (up to 13%), flatulence (up to 15%), oral pain (up to 14%), GERD/reflux esophagitis (up to 12%), glossodynia (up to 11%), laboratory abnormalities including lipase elevations (up to 56%), amylase elevations (up to 35%)
Common (1% to 10%): Hemorrhoids, dysphagia, esophagitis, abdominal discomfort, rectal hemorrhage, gingival bleeding, mouth ulceration, proctalgia, cheilitis, oral discomfort, eructation
Uncommon (0.1% to 1%): Pancreatitis, intestinal perforation, anal fistula
Postmarketing reports: Esophagitis[Ref]


Very common (10% or more): Neutropenia (18.3%), anemia (22%), thrombocytopenia (16.6%), bleeding events (18% to 37%), laboratory abnormalities including decreases in neutrophils (up to 77%), lymphocytes (up to 68%), leukocytes ( up to 78%), platelets (up to 68%), and hemoglobin (up to 79%)
Common (1% to 10%): Leukopenia, lymphopenia
Uncommon (0.1% to 1%): Pancytopenia
Postmarketing reports: Thrombotic microangiopathy[Ref]

Postmarketing bleeding events have included gastrointestinal, respiratory, tumor, urinary tract, and brain hemorrhages, some of which have been fatal. During clinical trials, bleeding events were reported in 37% (140 of 375) of patients with renal cell carcinoma (RCC) receiving sunitinib compared with 10% receiving interferon alpha. In the gastrointestinal stromal tumor (GIST) study, bleeding events were reported in 18% (37 of 202) of the sunitinib-treated patients compared with 17% (17 of 102) in placebo. Epistaxis was commonly reported; less frequent reports included rectal, gingival, upper gastrointestinal, genital, and wound bleeding.[Ref]

Nervous system

Very common (10% or more): Altered taste (21% to 47%), headache (13% to 26%), dizziness (up to 13.6%)
Common (1% to 10%): Peripheral neuropathy, paresthesia, hypoesthesia, hyperesthesia
Uncommon (0.1% to 1%): Reversible posterior leukoencephalopathy syndrome, cerebrovascular accident, transient ischemic attack
Postmarketing reports: Seizures[Ref]


Very common (10% or more): Laboratory abnormalities including elevations of ALT (up to 72%), AST (up to 61%), alkaline phosphatase (up to 63%), total bilirubin (up to 37%), and indirect bilirubin (up to 13%)
Uncommon (0.1% to 1%): Liver failure, cholecystitis , hepatitis, abnormal hepatic function
Postmarketing reports: Emphysematous cholecystitis, acalculous cholecystitis[Ref]


Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Hypersensitivity reactions, including angioedema[Ref]


Very common (10% or more): Skin discoloration (up to 30%), rash (up to 30%), hand-foot syndrome (14% to 29%), hair color changes (up to 29%), dry skin (15% to 23%), alopecia (up to 14%), erythema (14%), pruritus (14%)
Common (1% to 10%): Skin exfoliation, skin reaction, eczema, blister, acne, pruritus, hyperkeratosis, dermatitis, nail disorder
Uncommon (0.1% to 1%): Stevens-Johnson syndrome, toxic epidermal necrolysis
Frequency not reported: Erythema multiforme, necrotizing fasciitis
Postmarketing reports: Pyoderma gangrenosum[Ref]


Very common (10% or more): Hypertension (up to 34%), peripheral edema (up to 24%), chest pain (13%), laboratory finding of decreased left ventricular ejection fraction (up to 16%)
Common (1% to 10%): Venous thromboembolic events including deep vein thrombosis and pulmonary embolism, hot flush/flushing
Uncommon (0.1% to 1%): Congestive cardiac failure, cardiac failure, cardiomyopathy, pericardial effusion, left ventricular failure
Rare (less than 0.1%): Torsades de pointes
Postmarketing reports: Arterial thromboembolic events including cerebrovascular accident, transient ischemic attack, and cerebral infarction.[Ref]


Very common (10% or more): Myalgia/limb pain (11% to 40%), back pain (24% to 28%), arthralgia (19% to 23%), creatine kinase elevation (up to 49%)
Common (1% to 10%): Muscle spasms, muscular weakness
Uncommon (0.1% to 1%): Osteonecrosis of the jaw, fistula
Postmarketing reports: Fistula formation, myopathy and/or rhabdomyolysis[Ref]


Very common (10% or more): Epistaxis (21%), cough (27%), dyspnea (16% to 26%), nasopharyngitis (14%), oropharyngeal pain (14%), upper respiratory infection (11%)
Common (1% to 10%): Pulmonary embolism, pleural effusion, hemoptysis, nasal congestion, nasal dryness
Uncommon (0.1% to 1%): Pulmonary hemorrhage, respiratory failure
Postmarketing reports: Pulmonary embolism[Ref]


Very common (10% or more): Increased serum creatinine (up to 70%),
Rare (less than 0.1%): Nephrotic syndrome
Frequency not reported: Proteinuria
Postmarketing reports: Renal impairment and/or failure[Ref]


Very common (10% or more): Anorexia (up to 48%), weight loss (up to 16%), laboratory abnormalities including decreased potassium (up to 21% ), increased potassium (up to 18%), decreased calcium (up to 42%), increased calcium (13%), increased uric acid (up to 46%), increased glucose (up to 71%), decreased glucose (up to 22%), decreased sodium (up to 29%), increased sodium (up to 13%), decreased phosphorus (up to 36%), decreased magnesium (19% ), decreased albumin (up to 41%)
Common (1% to 10%): Dehydration
Uncommon (0.1% to 1%): Tumor lysis syndrome[Ref]


Very common (10% or more): Fatigue (33% to 76%), asthenia (16% to 34%), fever (up to 22%), chills (up to 14%)
Common (1% to 10%): Pain, influenza like symptoms
Uncommon (0.1% to 1%): Impaired wound healing[Ref]


Common (1% to 10%): Periorbital edema, eyelid edema, increased lacrimation[Ref]


Very common (10% or more): Hypothyroidism (16%)
Uncommon (0.1% to 1%): Hyperthyroidism[Ref]


Very common (10% or more): Insomnia (15% to 18%), depression (up to 11%)[Ref]


1. "Product Information. Sutent (sunitinib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.