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.
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.
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
- coughing up blood
- cracked lips
- decreased urination
- decreased urine output
- difficulty with breathing or swallowing
- dilated neck veins
- dry mouth
- extreme fatigue
- fast, slow, or irregular heartbeat
- increase in heart rate
- increased menstrual flow or vaginal bleeding
- irregular breathing
- labored breathing
- pounding in the ears
- prolonged bleeding from cuts
- rapid breathing
- rapid weight gain
- red or black, tarry stools
- red or dark brown urine
- shortness of breath
- sores, ulcers, or white spots on the lips, tongue, or inside the mouth
- sunken eyes
- swelling or inflammation of the mouth
- 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
- Bleeding from the rectum
- bleeding from wounds
- depressed mood
- dry skin and hair
- feeling cold
- hair loss
- hoarseness or husky voice
- loss of appetite
- muscle cramps and stiffness
- 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
- sudden, unexplained shortness of breath
- vision changes
- vomiting of blood or material that looks like coffee grounds
- Back pain
- chest discomfort
- cloudy or bloody urine
- darkening of the skin
- general feeling of tiredness or weakness
- irregular or slow heart rate
- light-colored stools
- mental depression
- skin rash
- stomach pain, continuing
- coughing up blood
- dark-colored urine
- heavy jaw feeling
- increased thirst
- 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
- 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
- Acid or sour stomach
- 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
- excess air or gas in the stomach or intestines
- feeling sad or empty
- full feeling
- hair color changes
- hair loss or thinning of the hair
- joint pain
- 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
- unable to sleep
For Healthcare Professionals
Applies to sunitinib: oral capsule
General side effects including fatigue (up to 74%), anorexia (up to 48%), asthenia (up to 34%), fever (up to 18%), and dehydration (up to 11%) have been reported. Cases of serious infection, some with fatal outcome, have also been reported.
Gastrointestinal side effects have included diarrhea (up to 66%), nausea (up to 58%), mucositis/stomatitis (up to 53%), dyspepsia (up to 46%), vomiting (up to 39%), abdominal pain (up to 39%), constipation (up to 34%), flatulence (up to 14%), and glossodynia (up to 11%). Laboratory abnormalities have included increased lipase (up to 56%) and increased amylase (up to 35%).
Hematologic side effects have included bleeding events (up to 37%) and epistaxis (up to 21%). Hematologic laboratory abnormalities have included neutropenia (up to 77%), lymphocytopenia (up to 68%), thrombocytopenia (up to 68%), anemia (up to 79%) and leukopenia (up to 78%). Fatal hemorrhage has also been reported.
Four patients (2%) in the two RCC studies had venous thromboembolic events reported. Two of the patients had pulmonary embolism (both grade 4) and two patients had deep venous thrombosis (DVT) (both grade 3). Dose interruption occurred in one of these cases. Seven patients (3%) on sunitinib (the active ingredient contained in Sutent) in GIST Study A experienced venous thromboembolic events. Five of the seven were grade 3 DVTs, and two were grade 1 or 2. Four of these seven GIST patients discontinued treatment following first observation of DVT. Cases of erythrocytosis and macrocytosis have also been reported.
Postmarketing reports have included arterial thromboembolic events, some with fatal outcomes. The most frequent events included cerebrovascular accident, transient ischemic attack and cerebral infarction. Other postmarketing reports have included pulmonary embolism and pulmonary hemorrhage, some with fatal outcomes, cases of fatal hemorrhage associated with thrombocytopenia, and thrombotic microangiopathy.
Patients with seizures and signs and symptoms consistent with RPLS, such as hypertension, headache, decreased alertness, altered mental functioning, and visual loss, including cortical blindness should be controlled with medical management including control of hypertension. Temporary suspension of sunitinib (the active ingredient contained in Sutent) is recommended. Following resolution, treatment may be resumed at the discretion of the treating physician.
Nervous system side effects have included altered taste (up to 47%), headache (up to 23%), and dizziness (up to 11%).
In clinical studies of sunitinib, seizures have been observed in subjects with radiological evidence of brain metastases. There have also been rare (less than 1%) reports of subjects presenting with seizures and radiological evidence of reversible posterior leukoencephalopathy syndrome (RPLS), including fatalities. A case of transient sunitinib-induced coma has also been reported.
Postmarketing case reports of hyperammonemic encephalopathy have been received.
Hepatic side effects have included liver failure (0.3%), including fatalities, and cholecystitis. Laboratory abnormalities have included elevated AST (up to 72%), elevated ALT (up to 61%), elevated total bilirubin (up to 37%), and elevated indirect bilirubin (13%).
Hypersensitivity reactions have included angioedema and fistula formation.
Dermatologic side effects have included skin discoloration (up to 30%), rash (up to 29%), hand-foot syndrome (up to 29%), hair color changes (up to 29%), dry skin (up to 23%), alopecia (up to 14%), erythema (up to 12%), and pruritus (up to 12%). A case of periodic hair depigmentation has also been reported. Other possible dermatologic side effects may include thickness or cracking of the skin, blisters or occasional rash on the palms of the hands and soles of the feet. Postmarketing reports of pyoderma gangrenosum have been received.
Cardiovascular side effects have included hypertension (up to 34%) and peripheral edema (up to 24%). Heart failure including fatalities have been reported. Laboratory abnormalities have included decreased left ventricular ejection fraction (up to 16%).
Cardiovascular events, including heart failure, myocardial disorders and cardiomyopathy, some of which were fatal, have been reported through postmarketing experience.
Data from nonclinical (in vitro and in vivo) studies indicate that sunitinib has the potential to inhibit the cardiac action potential repolarization process (e.g., prolongation of QT interval). In GIST Study A, 23 patients (11%) on sunitinib versus 12 (12%) on placebo had observed QT prolongation greater than 20 milliseconds from baseline. No consistent, clinically significant QTc prolongation has been observed in completed clinical studies.
Musculoskeletal side effects including pain in extremity, limb pain, limb discomfort or myalgia (up to 40%), arthralgia (up to 30%), and back pain (up to 28%) have been reported. Cases of myopathy and/or rhabdomyolysis have also been reported. Postmarketing reports of osteonecrosis of the jaw have been received.
Patients with signs or symptoms of muscle toxicity should be managed as per standard medical practice.
Respiratory side effects have included cough (up to 27%), dyspnea (up to 26%), nasopharyngitis (up to 14%), oropharyngeal pain (up to 14%), and upper respiratory tract infection (up to 11%).
Baseline urinalysis is recommended, and patients should be monitored for the development or worsening of proteinuria. The safety of continued sunitinib (the active ingredient contained in Sutent) treatment in patients with moderate to severe proteinuria has not been systematically evaluated. Sunitinib should be discontinued in patients with nephrotic syndrome.
Renal side effects have included laboratory abnormalities in creatinine (up to 70%). Postmarketing reports have included cases of proteinuria, rare cases of nephrotic syndrome, and renal failure, including fatalities.
Metabolic side effects have included laboratory abnormalities such as hyperglycemia (up to 71%), elevated creatine kinase (up to 49%), uric acid (up to 46%), hypoalbuminemia (up to 41%), hypophosphatemia (up to 36%), hypocalcemia (up to 42%), hyponatremia (up to 29%), hypoglycemia (up to 22%), hypokalemia (up to 21%), hypomagnesemia (up to 19%), hyperkalemia (up to 18%), and hypernatremia (up to 13%). Postmarketing reports of hyperammonemia and tumor lysis syndrome have been received.
Other side effects including appetite disturbance (up to 9%) have been reported. Postmarketing reports of necrotizing fascitis have been received.
Ocular side effects including periorbital edema (up to 7%) and increased lacrimation (up to 7%) have been reported.
Endocrine side effects including hyperparathyroidism (up to 62%), hypothyroidism (up to 16%) and TSH elevations (up to 2%) have been reported.
Severe fatigue has been reported to be a result of the onset of hypothyroidism.
Patients with symptoms suggestive of hypothyroidism should have laboratory monitoring of thyroid function performed and be treated as per standard medical practice.
Three medical doctors stated in a letter to the New England Journal of Medicine that for their group of 65 patients treated with sunitinib, the incidence of laboratory evidence of thyroid dysfunction was 60% to 70%. They made a general recommendation for monitoring thyroid dysfunction in patients receiving sunitinib or similar compounds.
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