Skip to main content

Sunitinib Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Aug 15, 2023.

Applies to sunitinib: oral capsule.


Oral route (Capsule)

Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue sunitinib malate as recommended.

Serious side effects of Sunitinib

Along with its needed effects, sunitinib 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

Less common


Incidence not known

Other side effects of Sunitinib

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

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]

Frequently asked questions


1. Product Information. Sutent (sunitinib). Pfizer U.S. Pharmaceuticals Group. 2006.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.