Pazopanib Side Effects

It is possible that some side effects of pazopanib 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 pazopanib: oral tablet

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

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

More common
  • Abdominal or stomach pain or tenderness
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blurred vision
  • chest pain
  • chills
  • clay colored stools
  • cloudy urine
  • constipation
  • cough
  • coughing up blood
  • dark urine
  • decreased appetite
  • depressed mood
  • difficulty with breathing or swallowing
  • dizziness
  • dry skin and hair
  • feeling cold
  • fever
  • hair loss
  • headache
  • hoarseness or husky voice
  • increased menstrual flow or vaginal bleeding
  • itching
  • loss of appetite
  • lower back or side pain
  • muscle cramps and stiffness
  • nausea and vomiting
  • nervousness
  • nosebleeds
  • painful or difficult urination
  • pale skin
  • paralysis
  • pinpoint red spots on the skin
  • pounding in the ears
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • redness, swelling, or pain of the skin
  • scaling of the skin on the hands and feet
  • shortness of breath
  • skin rash
  • slow or fast heartbeat
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling of the feet or lower legs
  • swollen glands
  • tingling of the hands and feet
  • ulceration of the skin
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • weight gain
  • yellow eyes or skin
Less common
  • Bleeding from rectum or bloody stools
  • bloody nose
  • chest discomfort
  • confusion
  • fainting
  • irregular heartbeat
  • irregular or slow heart rate
  • numbness or tingling in the face, arms, or legs
  • pain or discomfort in the shoulders, arms, jaw, back, or neck
  • sweating
  • swelling or puffiness of the face
  • trouble speaking, thinking, or walking

Some pazopanib 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
  • Change in hair color
  • change in taste
  • decreased weight
  • diarrhea
  • hair loss
  • lack or loss of strength
  • loss of taste
  • thinning of the hair
  • weight loss
Less common
  • Acid or sour stomach
  • belching
  • heartburn
  • indigestion
  • stomach discomfort, upset, or pain

For Healthcare Professionals

Applies to pazopanib: oral tablet

Hepatic

-ALT and AST elevations occurred early in the treatment course; 92.5% of all transaminase elevations of any grade occurred in the first 18 weeks.
-Hepatic failure was the cause of death for 0.2% of RCC patients and 0.4% of STS patients.[Ref]

Very common (10% or more): Increased ALT (up to 53%), increased AST (up to 53%), increased total bilirubin (up to 36%), increased alkaline phosphatase (up to 32%)
Common (1% to 10%): Abnormal hepatic function, hepatotoxicity, decreased alkaline phosphatase, increased gamma-glutamyltransferase (GGT), abnormal liver function test
Uncommon (0.1% to 1%): Jaundice, drug-induced liver injury, hepatic failure, increased hepatic enzyme
Postmarketing reports: Increased GGT[Ref]

Cardiovascular

-A majority of the patients with myocardial dysfunction had concurrent hypertension which may have exacerbated cardiac dysfunction in patients at risk possibly by increasing cardiac afterload.
-Cardiac dysfunction included left ventricular dysfunction, cardiac failure, and restrictive cardiomyopathy.
-Venous thromboembolic events included deep vein thrombosis, pulmonary embolism, and thrombosis terms.[Ref]

Very common (10% or more): Hypertension (up to 42%), myocardial dysfunction (up to 11%), chest pain (up to 10%)
Common (1% to 10%): Venous thromboembolic events, cardiac dysfunction, bradycardia, QT prolongation, myocardial infarction or ischemia, hot flush, flushing
Uncommon (0.1% to 1%): Torsades de pointes, congestive heart failure, fatal arterial thromboembolic events, hypertensive crisis[Ref]

Other

Very common (10% or more): Tumor pain (up to 32%), hemorrhagic events (up to 13%)
Common (1% to 10%): Edema, epistaxis, mouth ulceration, dry mouth, mucosal inflammation, gingival infection, hiccups
Uncommon (0.1% to 1%): Fatal hemorrhage, cerebral/intracranial hemorrhage, infections (with or without neutropenia), infectious peritonitis, menorrhagia, metrorrhagia, oropharyngeal pain
Postmarketing reports: Infections (with or without neutropenia)[Ref]

-RCC: The most common hemorrhagic events were hematuria, epistaxis, hemoptysis, and rectal hemorrhage.
-STS: The most common hemorrhagic events were epistaxis, mouth hemorrhage, and anal hemorrhage.
-Edema events included peripheral edema, eye edema, localized edema, and face edema.[Ref]

Renal

-TMA included thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS).[Ref]

Very common (10% or more): Increased creatinine (up to 26%), proteinuria (up to 12%)
Common (1% to 10%): Increased urea
Uncommon (0.1% to 1%): Nephrotic syndrome, thrombotic microangiopathy (TMA)
Postmarketing reports: Thrombotic microangiopathy (TMA)[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 59%), nausea (up to 56%), vomiting (up to 33%), gastrointestinal pain (up to 23%), abdominal pain (up to 14%), mucositis (up to 12%), stomatitis (up to 11%)
Common (1% to 10%): Dyspepsia, flatulence, abdominal distension
Uncommon (0.1% to 1%): Perforation or fistula, fatal perforations, hematochezia, melena, frequent bowel movements, hematemesis, pancreatitis, peritonitis
Postmarketing reports: Pancreatitis, flatulence[Ref]

Nervous system

Very common (10% or more): Fatigue (up to 65%), dysgeusia (up to 28%), headache (up to 23%), dizziness (up to 11%)
Common (1% to 10%): Insomnia, dysphonia, lethargy, paresthesia, peripheral sensory neuropathy, chills
Uncommon (0.1% to 1%): Hypoesthesia, somnolence, mucous membrane disorder, cerebral infarction, transient ischemic attack, cerebrovascular accident, ischemic stroke, posterior reversible encephalopathy syndrome/reversible posterior leukoencephalopathy syndrome (PRES/RPLS)
Postmarketing reports: PRES/RPLS[Ref]

-Dysgeusia included ageusia and hypogeusia.[Ref]

Endocrine

Common (1% to 10%): Hypothyroidism, increased thyroid stimulating hormone
Uncommon (0.1% to 1%): Abnormal thyroid function test[Ref]

General

-Renal cell carcinoma (RCC): The most commonly observed adverse reactions (20% or more) were diarrhea, hypertension, hair color change, nausea, fatigue, anorexia, and vomiting.

-Soft tissue sarcoma (STS): The most commonly observed adverse reactions (20% or more) were fatigue, diarrhea, nausea, decreased weight, hypertension, decreased appetite, vomiting, tumor pain, hair color changes, musculoskeletal pain, headache, dysgeusia, dyspnea, and skin hypopigmentation.[Ref]

Dermatologic

Very common (10% or more): Hair color changes (up to 39%), skin hypopigmentation (up to 21%), exfoliative rash (up to 18%), palmar-plantar erythrodysesthesia syndrome (up to 18%), alopecia (up to 12%), rash (up to 11%)
Common (1% to 10%): Dry skin, skin depigmentation, nail disorder, pruritus, erythema, hyperhidrosis
Uncommon (0.1% to 1%): Skin exfoliation, photosensitivity reaction, erythematous rash, skin disorder, macular rash, pruritic rash, vesicular rash, papular rash, skin ulcer[Ref]

Genitourinary

Common (1% to 10%): Hematuria[Ref]

Hematologic

Very common (10% or more): Leukopenia (up to 44%), lymphocytopenia (up to 43%), thrombocytopenia (up to 36%), neutropenia (up to 34%), anemia (up to 27%)
Common (1% to 10%): Decreased white blood cell count
Uncommon (0.1% to 1%): Decreased platelet count[Ref]

Metabolic

Very common (10% or more): Decreased weight (up to 48%), increased glucose (up to 45%), decreased appetite (up to 40%), increased albumin (up to 34%), decreased albumin (up to 34%), decreased phosphorus (up to 34%), decreased calcium (up to 33%), decreased sodium (up to 31%), increased potassium (up to 27%), decreased magnesium (up to 26%), anorexia (up to 22%), decreased glucose (up to 17%)
Common (1% to 10%): Increased lipase, increased amylase, dehydration, abnormal blood cholesterol[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (up to 23%), myalgia (up to 23%), asthenia (up to 14%)
Common (1% to 10%): Arthralgia, muscle spasms[Ref]

Ocular

Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Eyelash discoloration

Oncologic

Frequency not reported: Increased toxicity and mortality with other cancer therapies

-Fatal toxicities including pulmonary hemorrhage, gastrointestinal hemorrhage, and sudden death have occurred when used with other cancer agents.

Respiratory

Very common (10% or more): Dyspnea (up to 20%), cough (up to 17%)
Common (1% to 10%): Pneumothorax
Uncommon (0.1% to 1%): Rhinorrhea[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Votrient (pazopanib)." GlaxoSmithKline, Research Triangle Park, NC.

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 material does not endorse drugs, diagnose patients, or recommend therapy. This 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 combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials 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 substances you are taking, check with your doctor, nurse, or pharmacist.

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