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
Get emergency medical help if you have any of these signs of an allergic reaction while taking pazopanib (the active ingredient contained in Votrient) hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using pazopanib and call your doctor at once if you have a serious side effect such as:
slow healing of a wound or surgical incision;
dizziness, fainting, fast or pounding heartbeat;
fever, chills, easy bruising, flu symptoms, sores in your mouth and throat;
feeling short of breath (even with mild exertion), swelling, rapid weight gain;
bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
nosebleed, bleeding gums;
any wound that will not heal;
nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
sudden numbness or weakness (especially on one side of the body), sudden severe headache, confusion, problems with vision, speech, or balance;
sudden cough, wheezing, rapid breathing, coughing up blood;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
pain, swelling, warmth, or redness in one or both legs; or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects of pazopanib may include:
mild nausea or vomiting, diarrhea;
changes in hair or skin color;
joint or muscle pain;
tumor pain, mild headache; or
unusual or unpleasant taste in your mouth.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
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%), 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%), and myalgia (up to 23%) 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%).
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