Summary

Commonly reported side effects of sunitinib include: oral candidiasis, asthenia, decreased left ventricular ejection fraction, diarrhea, hypokalemia, lymphocytopenia, mucositis, neutropenia, vomiting, and hypertension. Other side effects include: severe hypertension. Continue reading for a comprehensive list of adverse effects.

Applies to sunitinib: oral capsule.

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

• Bleeding gums
• bloating or swelling of the face, arms, hands, fingers, lower legs, or feet
• blurred vision
• chest pain
• chills
• confusion
• constipation
• coughing up blood
• cracked lips
• decreased urine output and frequency
• diarrhea
• difficulty swallowing
• dilated neck veins
• dizziness
• dry mouth
• fainting
• fast, slow, or irregular heartbeat
• fever
• headache
• increased menstrual flow or vaginal bleeding
• irregular 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
• trouble 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
• depressed mood
• dry skin and hair
• excessive sweating
• 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, 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

• Back pain
• chest discomfort
• cloudy or bloody urine
• darkening of the skin
• drowsiness
• general feeling of tiredness or weakness
• light-colored stools
• mental depression
• seizures
• skin rash
• stomach pain, continuing

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
• sores, ulcers, or white spots on lips or tongue or inside the mouth
• sore throat
• sudden, severe chest pain
• unusual bleeding or bruising

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

• 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 or loss of strength
• loss of interest or pleasure
• loss of taste
• 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 or upset
• swelling or inflammation of the mouth
• swollen joints
• trouble concentrating
• trouble sleeping

For Healthcare Professionals

Applies to sunitinib: oral capsule.

General

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]

Gastrointestinal

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]

Hematologic

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]

Hepatic

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]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity

Postmarketing reports: Hypersensitivity reactions, including angioedema^[Ref]

Dermatologic

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]

Cardiovascular

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]

Musculoskeletal

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]

Respiratory

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]

Renal

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]

Metabolic

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]

Other

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]

Ocular

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

Endocrine

Very common (10% or more): Hypothyroidism (16%)

Uncommon (0.1% to 1%): Hyperthyroidism^[Ref]

Psychiatric

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