Sunitinib Side Effects

It is possible that some side effects of sunitinib may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to sunitinib: oral capsule

As well as its needed effects, sunitinib may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking sunitinib, check with your doctor immediately:

More common
  • Bleeding gums
  • bloating or swelling of the face, arms, hands, fingers, lower legs, or feet
  • blurred vision
  • chest pain
  • chills
  • confusion
  • coughing up blood
  • cracked lips
  • decreased urination
  • decreased urine output
  • diarrhea
  • difficulty with breathing or swallowing
  • dilated neck veins
  • dizziness
  • dry mouth
  • extreme fatigue
  • fainting
  • fast, slow, or irregular heartbeat
  • fever
  • headache
  • increase in heart rate
  • increased menstrual flow or vaginal bleeding
  • irregular breathing
  • labored 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
  • shortness of breath
  • 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
  • troubled breathing
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • wheezing
  • wrinkled skin
  • yellow eyes or skin
Less common
  • Bleeding from the rectum
  • bleeding from wounds
  • constipation
  • depressed mood
  • dry skin and hair
  • 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 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
  • vomiting of blood or material that looks like coffee grounds
Rare
  • Back pain
  • chest discomfort
  • cloudy or bloody urine
  • convulsions
  • darkening of the skin
  • drowsiness
  • general feeling of tiredness or weakness
  • irregular or slow heart rate
  • light-colored stools
  • mental depression
  • skin rash
  • stomach pain, continuing
Incidence not known
  • Cough
  • 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 sunitinib side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Acid or sour stomach
  • 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 intestines
  • feeling sad or empty
  • full feeling
  • hair color changes
  • hair loss or thinning of the hair
  • heartburn
  • irritability
  • 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
  • sleeplessness
  • stomach discomfort, upset, or pain
  • swollen joints
  • trouble concentrating
  • trouble sleeping
  • unable to sleep

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]

References

1. "Product Information. Sutent (sunitinib)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

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