Votrient Side Effects
Generic name: pazopanib
Note: This document provides detailed information about Votrient Side Effects associated with pazopanib. Some dosage forms listed on this page may not apply specifically to the brand name Votrient.
Applies to pazopanib: oral tablet.
Important warnings
This medicine can cause some serious health issues
Oral route (tablet)
Severe and fatal hepatotoxicity has occurred during clinical trials.
Monitor hepatic function.
Interrupt, reduce, or discontinue treatment as recommended.
Precautions
It is very important that your doctor check your progress at regular visits for any unwanted effects from the medicine. Blood and urine tests may be needed to check for unwanted effects.
Your blood pressure should be checked regularly during treatment with this medicine. Your doctor may need to treat you if you develop high blood pressure. Symptoms of high blood pressure are blurred vision, dizziness, nervousness, headache, pounding in the ears, or a slow or fast heartbeat.
Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Men and women should use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 2 weeks after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine could cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Cancer medicines can cause diarrhea, nausea, vomiting, or stomach pain in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea and vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem (eg, QT prolongation, Torsades de pointes).
Pazopanib may cause heart problems. Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain.
This medicine may increase your risk of having bleeding problems. Tell your doctor right away if you start to notice any signs of bleeding.
This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine at least 7 days before having a surgery.
Check with your doctor right away if you have new chest pain, trouble breathing, leg pain, swelling of the arms, hands, legs, or feet, or a cool or pale arm or leg. These may be symptoms of a blood clotting problem.
Check with your doctor right away if you start having severe stomach burning, cramps, or pains, bloody or black, tarry stools, trouble breathing, heartburn, indigestion, nausea, or vomiting of material that looks like coffee grounds. These could be symptoms of a serious bowel problem.
This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms of lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.
This medicine may increase your chance of having a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Check with your doctor right away if you have headaches, seizures, extreme drowsiness, confusion, or vision problems while using this medicine.
This medicine may cause hypothyroidism (underactive thyroid). Check with your doctor right away if you have depressed mood, dry skin and hair, feeling cold, hair loss, hoarseness or a husky voice, muscle cramps and stiffness, slowed heartbeat, weight gain, or unusual tiredness or weakness.
Pazopanib may cause serious side effects in the developing organs of children younger than 2 years of age. Check with your doctor if you have any concerns.
Pazopanib may cause kidney problems, including proteinuria or nephrotic syndrome. Check with your doctor right away if you have a cloudy or bloody urine, high blood pressure, or swelling of the face, feet or lower legs.
This medicine may also cause a serious reaction called tumor lysis syndrome (TLS). Call your doctor right away if you have a change in how much or how often you urinate, rapid weight gain, muscle or joint pain, swelling of the feet or lower legs, or unusual tiredness or weakness.
Call your doctor right away if you have a cough that would not go away, weight loss, night sweats, fever, chills, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or you feel generally ill. These may be symptoms of an infection.
This medicine may cause diarrhea, and in some cases it can be severe. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects of Votrient
Along with its needed effects, pazopanib (the active ingredient contained in Votrient) 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 pazopanib:
More common side effects
- 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, skin rash
- 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
- slow or fast heartbeat
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain or tenderness
- 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 side effects
- bleeding from the rectum or bloody stools
- bloody nose
- chest discomfort
- confusion
- fainting
- 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
Other side effects of Votrient
Some side effects of pazopanib 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 side effects
- 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 side effects
- belching
- heartburn
- indigestion
- stomach discomfort, upset, or pain
For healthcare professionals
Applies to pazopanib: oral tablet.
General adverse events
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]
Cardiovascular
- 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]
Renal
- 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]
Endocrine
- Common (1% to 10%): Hypothyroidism, increased thyroid stimulating hormone
- Uncommon (0.1% to 1%): Abnormal thyroid function test[Ref]
Hepatic
- 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]
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
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]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2009) "Product Information. Votrient (pazopanib)." GlaxoSmithKline
Frequently asked questions
- Does Votrient cure cancer or shrink tumors?
- How long does Votrient stay in your system?
- Is Votrient a chemotherapy treatment?
- Is Votrient immunotherapy?
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Further information
Votrient side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.