Votrient
Votrient Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Votrient (pazopanib) is used to treat kidney cancer, and it may also be used to treat certain other types of cancer (soft tissue sarcoma). It is a tyrosine kinase inhibitor. Common side effects include headache, loss of appetite, weight loss, altered sense of taste, nausea and vomiting (may be severe), diarrhea, numbness/tingling/redness in hands/feet, or feeling tired/weak.
The recommended dose of Votrient is 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). Votrient may interact with other drugs that can cause bleeding/bruising such as antiplatelet drugs, NSAIDs, aspirin, or blood thinners. It can also interact with azole antifungals, antidepressants, antibiotics, rifamycins, St. John's wort, seizures medications, HIV medicines, and other drugs that can affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, or sotalol. Tell your doctor all medications and supplements you use. Votrient is not recommended for use during pregnancy. It may harm a fetus. Discuss birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding. Our Votrient (pazopanib) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Votrient in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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;
- black, bloody, or tarry stools;
- coughing up blood or vomit that looks like coffee grounds;
- nausea, stomach pain, low fever, 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 headache, confusion, problems with vision, speech, or balance;
- chest pain or heavy feeling, pain spreading to the arm or shoulder; or
- dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
- mild nausea or vomiting, diarrhea;
- changes in hair color;
- tired feeling; or
- headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Votrient (Pazopanib Tablets) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Votrient Overview - Patient Information: Side Effects
Headache, loss of appetite, weight loss, altered sense of taste, numbness/tingling/redness in hands/feet, or feeling tired/weak may occur. If these effects persist or worsen, tell your doctor or pharmacist promptly.
Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals or limiting activity may help lessen some of these effects.
Many people have more frequent/loose stools or diarrhea while taking this medication. Diarrhea can cause a serious loss of body water (dehydration). Drink plenty of fluids and minerals (electrolytes) to replace what is lost. Tell your doctor immediately if you develop signs of dehydration (such as extreme thirst, decreased urination, muscle cramps, weakness, fainting).
If diarrhea persists or becomes a problem, your doctor may lower the dose or have you temporarily stop this medication. Do not stop or change the dose of this medicine without talking with your doctor. Tell your doctor immediately if you develop: persistent/severe diarrhea, abdominal or stomach pain/cramping, blood in your stool.
This medication may cause high blood pressure. Your doctor will check your blood pressure regularly while you are taking this medication and may start you on a medication to lower your blood pressure.
Temporary hair loss and/or change in hair or skin color may occur. Normal hair growth should return after treatment has ended.
Many people using this medication have serious side effects and require a dosage reduction or drug discontinuation. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.
Tell your doctor immediately if any of these rare but very serious side effects occur: signs of an underactive thyroid (such as unusual weight gain, cold intolerance, slow heartbeat, unusual tiredness), signs of infection (such as fever, chills, persistent sore throat), wounds that do not heal, signs of congestive heart failure (such as swelling of the ankles/feet, trouble breathing, unusual tiredness).
This drug can cause serious (rarely fatal) bleeding. Tell your doctor immediately if you have any signs of unusual bleeding such as: bloody/black stools, easy bleeding/bruising (such as nose bleed or bloody/pinkish urine), vomit that looks like coffee grounds, severe stomach/abdominal pain, coughing up blood.
Seek immediate medical attention if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), signs of a stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion), signs of a blood clot in the arms/legs/lungs (such as pain/redness/swelling in the arm/leg/calf/groin, coughing up blood, chest pain, trouble breathing), signs of a certain brain condition (such as headache, seizure, confusion, decreased alertness, vision changes, blindness).
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Votrient (Pazopanib Tablets)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Votrient FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Potentially serious adverse reactions with VOTRIENT included hepatotoxicity, QT prolongation and torsades de pointes, hemorrhagic events, arterial thrombotic events, gastrointestinal perforation and fistula, and hypertensive crisis [see WARNINGS AND PRECAUTIONS].
The safety of VOTRIENT has been evaluated in 977 patients in the monotherapy studies which included 586 patients with RCC at the time of NDA submission. With a median duration of treatment of 7.4 months (range 0.1 to 27.6), the most commonly observed adverse reactions ( ≥ 20%) in the 586 patients were diarrhea, hypertension, hair color change, nausea, fatigue, anorexia, and vomiting.
The data described below reflect the safety profile of VOTRIENT in 290 RCC patients who participated in a randomized, double-blind, placebo-controlled study [see Clinical Studies]. The median duration of treatment was 7.4 months (range 0 to 23) for patients who received VOTRIENT and 3.8 months (range 0 to 22) for the placebo arm. Forty-two percent (42%) of patients on VOTRIENT required a dose interruption. Thirty-six percent (36%) of patients on VOTRIENT were dose reduced. Table 1 presents the most common adverse reactions occurring in > 10% of patients who received VOTRIENT.
Table 1: Adverse Reactions Occurring
in ≥ 10% of Patients who Received VOTRIENT
| Adverse Reactions | VOTRIENT (N = 290) |
Placebo (N = 145) |
||||
| All Gradesa % | Grade 3 % | Grade 4 % | All Gradesa % | Grade 3 % | Grade 4 % | |
| Diarrhea | 52 | 3 | < 1 | 9 | < 1 | 0 |
| Hypertension | 40 | 4 | 0 | 10 | < 1 | 0 |
| Hair color changes | 38 | < 1 | 0 | 3 | 0 | 0 |
| Nausea | 26 | < 1 | 0 | 9 | 0 | 0 |
| Anorexia | 22 | 2 | 0 | 10 | < 1 | 0 |
| Vomiting | 21 | 2 | < 1 | 8 | 2 | 0 |
| Fatigue | 19 | 2 | 0 | 8 | 1 | 1 |
| Asthenia | 14 | 3 | 0 | 8 | 0 | 0 |
| Abdominal pain | 11 | 2 | 0 | 1 | 0 | 0 |
| Headache | 10 | 0 | 0 | 5 | 0 | 0 |
| a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3. | ||||||
Other adverse reactions observed more commonly in patients treated with VOTRIENT than placebo and that occurred in < 10% (any grade) were alopecia (8% versus < 1%), chest pain (5% versus 1%), dysgeusia (altered taste) (8% versus < 1%), dyspepsia (5% versus < 1%), facial edema (1% versus 0%), palmar-plantar erythrodysesthesia (hand-foot syndrome) (6% versus < 1%), proteinuria (9% versus 0%), rash (8% versus 3%), skin depigmentation (3% versus 0%), and weight decreased (9% versus 3%).
Table 2 presents the most common laboratory abnormalities occurring in > 10% of patients who received VOTRIENT and more commonly ( ≥ 5%) in patients who received VOTRIENT versus placebo.
Table 2: Selected Laboratory Abnormalities Occurring in
> 10% of Patients who Received VOTRIENT and More Commonly ( ≥ 5%) in Patients who Received VOTRIENT
Versus Placebo
| Parameters | VOTRIENT (N = 290) |
Placebo (N = 145) |
||||
| All Gradesa % | Grade 3 % | Grade 4 % | All Gradesa % | Grade 3 % | Grade 4 % | |
| Hematologic | ||||||
| Leukopenia | 37 | 0 | 0 | 6 | 0 | 0 |
| Neutropenia | 34 | 1 | < 1 | 6 | 0 | 0 |
| Thromb ocy topeni a | 32 | < 1 | < 1 | 5 | 0 | < 1 |
| Lymphocytopenia | 31 | 4 | < 1 | 24 | 1 | 0 |
| Chemistry | ||||||
| ALT increased | 53 | 10 | 2 | 22 | 1 | 0 |
| AST increased | 53 | 7 | < 1 | 19 | < 1 | 0 |
| Glucose increased | 41 | < 1 | 0 | 33 | 1 | 0 |
| Total bilirubin increased | 36 | 3 | < 1 | 10 | 1 | < 1 |
| Phosphorus decreased | 34 | 4 | 0 | 11 | 0 | 0 |
| Sodium decreased | 31 | 4 | 1 | 24 | 4 | 0 |
| Magnesium decreased | 26 | < 1 | 1 | 14 | 0 | 0 |
| Glucose decreased | 17 | 0 | < 1 | 3 | 0 | 0 |
| a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3. | ||||||
Hepatic Toxicity
In a controlled clinical study with VOTRIENT for the treatment of RCC, ALT > 3 X ULN was reported in 18% and 3% of the VOTRIENT and placebo groups, respectively. ALT > 10 X ULN was reported in 4% of patients who received VOTRIENT and in < 1% of patients who received placebo. Concurrent elevation in ALT > 3 X ULN and bilirubin > 2 X ULN in the absence of significant alkaline phosphatase > 3 X ULN occurred in 5/290 (2%) of patients on VOTRIENT and 2/145 (1%) on placebo. [See DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS.]
Hypertension
In a controlled clinical study with VOTRIENT for the treatment of RCC, 115/290 patients (40%) receiving VOTRIENT compared with 15/145 patients (10%) on placebo experienced hypertension. Grade 3 hypertension was reported in 13/290 patients (4%) receiving VOTRIENT compared with 1/145 patients ( < 1%) on placebo. The majority of cases of hypertension were manageable with anti-hypertensive agents or dose reductions with 2/290 patients ( < 1%) permanently discontinuing treatment with VOTRIENT because of hypertension. VOTRIENT has been associated with hypertensive crisis in patients with various cancer types including RCC. In the overall safety population for RCC (N = 586), one patient had hypertensive crisis on VOTRIENT. [See WARNINGS AND PRECAUTIONS.]
QT Prolongation and Torsades de Pointes
In a controlled clinical study with VOTRIENT, QT prolongation ( ≥ 500 msec) was identified on routine electrocardiogram monitoring in 3/290 (1%) of patients treated with VOTRIENT compared with no patients on placebo. Torsades de pointes was reported in 2/586 ( < 1%) patients treated with VOTRIENT in the RCC studies. [See WARNINGS AND PRECAUTIONS.]
Arterial Thrombotic Events
In a controlled clinical study with VOTRIENT, the incidences of arterial thrombotic events such as myocardial infarction/ischemia [5/290 (2%)], cerebral vascular accident [1/290 ( < 1%)], and transient ischemic attack [4/290 (1%)] were higher in patients treated with VOTRIENT compared to the placebo arm (0/145 for each event). [See WARNINGS AND PRECAUTIONS.]
Hemorrhagic Events
In a controlled clinical study with VOTRIENT, 37/290 patients (13%) treated with VOTRIENT and 7/145 patients (5%) on placebo experienced at least 1 hemorrhagic event. The most common hemorrhagic events in the patients treated with VOTRIENT were hematuria (4%), epistaxis (2%), hemoptysis (2%), and rectal hemorrhage (1%). Nine (9/37) patients treated with VOTRIENT who had hemorrhagic events experienced serious events including pulmonary, gastrointestinal, and genitourinary hemorrhage. Four (4/290) (1%) patients treated with VOTRIENT died from hemorrhage compared with no (0/145) (0%) patients on placebo. [See WARNINGS AND PRECAUTIONS.] In the overall safety population in RCC (N = 586), cerebral/intracranial hemorrhage was observed in 2/586 ( < 1%) patients treated with VOTRIENT.
Hypothyroidism
In a controlled clinical study with VOTRIENT, more patients had a shift from thyroid stimulating hormone (TSH) within the normal range at baseline to above the normal range at any post-baseline visit in VOTRIENT compared with the placebo arm (27% compared with 5%, respectively). Hypothyroidism was reported as an adverse reaction in 19 patients (7%) treated with VOTRIENT and no patients (0%) in the placebo arm. [See WARNINGS AND PRECAUTIONS.]
Diarrhea
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.
Proteinuria
In the controlled clinical study with VOTRIENT, proteinuria has been reported as an adverse reaction in 27 patients (9%) treated with VOTRIENT. In 2 patients, proteinuria led to discontinuation of treatment with VOTRIENT. [See WARNINGS AND PRECAUTIONS.]
Lipase Elevations
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. In clinical RCC studies of VOTRIENT, clinical pancreatitis was observed in 4/586 patients ( < 1%).
Cardiac Dysfunction
Pazopanib has been associated with cardiac dysfunction (such as a decrease in ejection fraction and congestive heart failure) in patients with various cancer types, including RCC. In the overall safety population for RCC (N = 586), cardiac dysfunction was observed in 4/586 patients ( < 1%).
Read the entire FDA prescribing information for Votrient (Pazopanib Tablets) »
Additional Votrient Information
Votrient - User Reviews
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