Votrient Side Effects
Generic Name: pazopanib
Note: This document contains side effect information about pazopanib. Some of the dosage forms listed on this page may not apply to the brand name Votrient.
Some side effects of Votrient may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to pazopanib: oral tablet
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
- Abdominal or stomach pain or tenderness
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- chest pain
- clay colored stools
- cloudy urine
- coughing up blood
- dark urine
- decreased appetite
- depressed mood
- difficulty with breathing or swallowing
- dry skin and hair
- feeling cold
- hair loss
- hoarseness or husky voice
- increased menstrual flow or vaginal bleeding
- loss of appetite
- lower back or side pain
- muscle cramps and stiffness
- nausea and vomiting
- painful or difficult urination
- pale skin
- 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
- Bleeding from rectum or bloody stools
- bloody nose
- chest discomfort
- 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
- swelling or puffiness of the face
- trouble speaking, thinking, or walking
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
- Change in hair color
- change in taste
- decreased weight
- hair loss
- lack or loss of strength
- loss of taste
- thinning of the hair
- weight loss
- Acid or sour stomach
- stomach discomfort, upset, or pain
For Healthcare Professionals
Applies to pazopanib: oral tablet
Cardiovascular side effects including hypertension (up to 42%), peripheral edema (up to 14%), myocardial dysfunction (up to 11%), chest pain (up to 10%), left ventricular dysfunction (up to 8%), thrombotic microangiopathy, bradycardia (2%), myocardial infarction/ischemia (up to 2%), QT prolongation (up to 2%), transient ischemic attack (up to 1%), congestive heart failure (up to 1%), cerebral vascular accident (less than 1%), and torsades de pointes (less than 1%) have been reported.
Dermatologic side effects including exfoliative rash (up to 18%), alopecia (up to 12%), skin disorder (up to 11%), skin hypopigmentation (up to 11%), dry skin (up to 6%), palmar-plantar erythrodysesthesia (up to 6%), and nail disorder (up to 5%) have been reported.
Endocrine side effects including hypothyroidism (up to 8%) have been reported.
Gastrointestinal side effects including diarrhea (up to 59%), nausea (up to 56%), vomiting (up to 33%), dysgeusia (up to 28%), gastrointestinal pain (up to 23%), anorexia, (up to 22%), mucositis (up to 12%), abdominal pain (up to 11%), stomatitis (up to 11%), dyspepsia (up to 7%), and pancreatitis (less than 1%) have been reported.
In a single-arm clinical study, increases in lipase values were observed for 48/181 patients (27%). Elevations in lipase as an adverse reaction were reported for 10 patients (4%) and were grade 3 for 6 patients and grade 4 for 1 patient.
Diarrhea occurred frequently and was predominantly mild to moderate in severity. Patients should be advised how to manage mild diarrhea and to notify their healthcare provider if moderate to severe diarrhea occurs so appropriate management can be implemented to minimize its impact.
General side effects including fatigue (up to 65%) and asthenia (up to 14%) have been reported.
Hematologic side effects including leucopenia (up to 44%), neutropenia (up to 34%), thrombocytopenia (up to 36%), lymphocytopenia (up to 43%), and at least one hemorrhagic event (up to 22%) have been reported.
The most common hemorrhagic events in patients treated with pazopanib were epistaxis (up to 8%), hematuria (up to 4%), mouth hemorrhage (up to 3%), hemoptysis (up to 2%), and anal or rectal hemorrhage (up to 2%). In the RCC trials, nine (9/37) patients treated with pazopanib who had hemorrhagic events experienced serious events including pulmonary, gastrointestinal, and genitourinary hemorrhage. One percent (4/290) of patients treated with pazopanib died from hemorrhage. In the overall safety population in renal cell carcinoma (N = 586), cerebral/intracranial hemorrhage was observed in less than 1% (2/586) of patients treated with pazopanib.
In the randomized STS trial, grade 4 hemorrhagic events occurred in 1% (3/240) of patients and included hemorrhage, subarachnoid hemorrhage and peritoneal hemorrhage.
Hepatic side effects including increased ALT (up to 53%), increased AST (up to 53%), and increased total bilirubin (up to 36%) have been reported.
Metabolic side effects including increased glucose (up to 45%), decreased albumin (up to 34%), decreased phosphorus (up to 34%), increased alkaline phosphatase (up to 32%), decreased sodium (up to 31%), decreased magnesium (up to 26%), decreased glucose (up to 17%), and increased potassium (up to 16%) have been reported.
Musculoskeletal side effects including musculoskeletal pain (up to 23%), myalgia (up to 23%), arthralgia, and muscle spasms have been reported.
Nervous system side effects including headache (up to 23%), and dizziness (up to 11%) have been reported.
Ocular side effects including blurred vision (up to 5%) have been reported.
Other side effects including hair color changes (up to 39%), decreased weight (up to 48%), decreased appetite (up to 40%), tumor pain (up to 29%), insomnia (up to 9%), dysphonia (up to 8%), chills (up to 5%), and facial edema (up to 1%) have been reported.
Renal side effects including proteinuria (up to 9%) have been reported.
Respiratory side effects including dyspnea (up to 20%), cough (up to 17%), and epistaxis (up to 8%).
More about Votrient (pazopanib)
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