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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.
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.
Applies to sunitinib: oral capsule
Oral route (Capsule)
Hepatotoxicity has been observed in clinical trials and postmarketing experience. Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended.
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:
Incidence not known
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:
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.
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
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
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.
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
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
Uncommon (0.1% to 1%): Hypersensitivity
Postmarketing reports: Hypersensitivity reactions, including angioedema
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
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.
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
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
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
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
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
Common (1% to 10%): Periorbital edema, eyelid edema, increased lacrimation
Very common (10% or more): Hypothyroidism (16%)
Uncommon (0.1% to 1%): Hyperthyroidism
Very common (10% or more): Insomnia (15% to 18%), depression (up to 11%)
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