Sunitinib Side Effects

Brand Names: Sutent

Please note - some side effects for Sunitinib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Sunitinib - for the Consumer

Sunitinib

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sunitinib:

Arm or leg discomfort; back pain; changes in taste; constipation; diarrhea; dizziness; dry, thick, or cracked skin; headache; indigestion; mild loss of appetite or stomach pain; mouth or tongue pain, swelling, soreness, or irritation; nausea; skin or hair discoloration; stomach upset; tiredness; trouble sleeping; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry, or bloody stools; blistering or rash on the palms of hands and soles of feet; bloody urine; calf or leg pain, redness, swelling, or tenderness; chest pain; coughing up blood; decreased urination; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent cough or sore throat; joint pain; mental or mood changes (eg, decreased alertness, depression, irritability, nervousness); muscle pain, tenderness, or weakness; numbness of an arm or leg; numbness or tingling of the hands or feet; seizures; severe or persistent headache, dizziness, stomach pain, back pain, tiredness, or weakness; shortness of breath; swelling of the hands, ankles, feet, or legs; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the eyes or skin); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech, vision problems); symptoms of thyroid problems (eg, changes in menstrual period, excessive sweating, hair loss, increased appetite, increased sensitivity to hot or cold conditions, sudden weight changes, tremors, worsening tiredness); unusual or severe bruising or bleeding (eg, bleeding gums, nosebleeds); vision changes or vision loss; vomiting blood or vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

General

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

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

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 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, some with fatal outcomes, cases of fatal hemorrhage associated with thrombocytopenia, and thrombotic microangiopathy.

Nervous system

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 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). None of these subjects had a fatal outcome to the event. A case of transient sunitinib-induced coma has also been reported.

Postmarketing case reports of hyperammonemic encephalopathy have been received.

Hepatic

Hepatic side effects have included liver failure (0.3%), including fatalities. 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

Hypersensitivity reactions have included angioedema and fistula formation.

Dermatologic

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.

Cardiovascular

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

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.

Patients with signs or symptoms of muscle toxicity should be managed as per standard medical practice.

Respiratory

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%).

Renal

Baseline urinalysis is recommended, and patients should be monitored for the development or worsening of proteinuria. The safety of continued sunitinib 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

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 have been received.

Other

Other side effects including appetite disturbance (up to 9%) have been reported.

Ocular

Ocular side effects including periorbital edema (up to 7%) and increased lacrimation (up to 7%) have been reported.

Endocrine

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.

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 information does not endorse drugs, diagnose patients, or recommend therapy. This drug 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 drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information 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 drugs you are taking, check with your doctor, nurse, or pharmacist.