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Votrient

Last reviewed on RxList: 11/11/2020
Votrient Side Effects Center

What Is Votrient?

Votrient (pazopanib) is a tyrosine kinase inhibitor used to treat kidney cancer, and it may also be used to treat certain other types of cancer (soft tissue sarcoma).

What Are Side Effects of Votrient?

Common side effects of Votrient include:

Many people have more frequent/loose stools or diarrhea while taking Votrient. Diarrhea can cause a serious loss of body water (dehydration). Tell your doctor if you develop signs of dehydration (such as extreme thirst, decreased urination, muscle cramps, weakness, or fainting). Votrient may cause high blood pressure. Temporary hair loss and/or change in hair or skin color may occur. Normal hair growth should return after treatment with Votrient has ended.

Dosage for Votrient

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.

What Drugs, Substances, or Supplements Interact with Votrient?

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.

Votrient During Pregnancy and Breastfeeding

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

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.

Votrient Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Pazopanib can cause life-threatening blood clots in the small blood vessels inside your organs, such as your brain or kidneys. Seek medical help right away if you have symptoms of this condition, such as a fever, tiredness, decreased urination, bruising, or nosebleeds.

Call your doctor at once if you have:

  • severe chest pain or headache, confusion, pounding in your neck or ears;
  • a seizure;
  • ongoing cough or breathing problems;
  • unusual bleeding or bruising;
  • any wound or surgical incision that will not heal;
  • heart problems--swelling, rapid weight gain, shortness of breath, fast or pounding heartbeats, fluttering in your chest, sudden dizziness (like you might pass out);
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • liver problems--nausea, vomiting, upper stomach pain, loss of appetite, tiredness, dark urine, or jaundice (yellowing of the skin or eyes).
  • signs of infection--fever, runny nose, sore throat, body aches, skin sores, pain or burning when you urinate;
  • signs of stomach bleeding--stomach pain or swelling, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • signs of a stroke or blood clot--sudden numbness or weakness, severe headache, slurred speech, vision problems, chest pain, sudden shortness of breath, pain or cold feeling in an arm or leg; or
  • signs of tumor cell breakdown--tiredness, muscle cramps or spasms, tingling, vomiting, diarrhea, fast or slow heart rate, little or no urination.

Liver problems may be more likely in adults older than 65.

Common side effects may include:

  • nausea, vomiting, diarrhea, stomach pain;
  • loss of appetite, weight loss;
  • trouble breathing;
  • tumor pain, bone pain, muscle pain;
  • headache, feeling tired;
  • changes in hair or skin color; or
  • changes in your sense of taste.

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)

Votrient Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

  • Hepatic Toxicity and Hepatic Impairment [see WARNINGS AND PRECAUTIONS]
  • QT Prolongation and Torsades de Pointes [see WARNINGS AND PRECAUTIONS]
  • Cardiac Dysfunction [see WARNINGS AND PRECAUTIONS]
  • Hemorrhagic Events [see WARNINGS AND PRECAUTIONS]
  • Arterial and Venous Thromboembolic Events [see WARNINGS AND PRECAUTIONS]
  • Thrombotic Microangiopathy [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Perforation and Fistula [see WARNINGS AND PRECAUTIONS]
  • Interstitial Lung Disease/Pneumonitis [see WARNINGS AND PRECAUTIONS]
  • Reversible Posterior Leukoencephalopathy Syndrome [see WARNINGS AND PRECAUTIONS]
  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Hypothyroidism [see WARNINGS AND PRECAUTIONS]
  • Proteinuria [see WARNINGS AND PRECAUTIONS]
  • Tumor Lysis Syndrome [see WARNINGS AND PRECAUTIONS]
  • Infection [see WARNINGS AND PRECAUTIONS]
  • Increased Toxicity with Other Cancer Therapy [see WARNINGS AND PRECAUTIONS]

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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Renal Cell Carcinoma

The safety of VOTRIENT has been evaluated in 977 patients in the monotherapy trials 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 (greater than or equal to 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 trial [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 of patients on VOTRIENT required a dose interruption. Thirty-six percent of patients on VOTRIENT were dose reduced. Table 1 presents the most common adverse reactions occurring in greater than or equal to 10% of patients who received VOTRIENT.

Table 1: Adverse Reactions Occurring in Greater Than or Equal to 10% of Patients with RCC Who Received VOTRIENT

Adverse ReactionsVOTRIENT
(N = 290)
Placebo
(N = 145)
All Gradesa %Grade 3 %Grade 4 %All Gradesa %Grade 3 %Grade 4 %
Diarrhea523< 19< 10
Hypertension404010< 10
Hair color changes38< 10300
Nausea26< 10900
Anorexia222010< 10
Vomiting212< 1820
Fatigue1920811
Asthenia1430800
Abdominal pain1120100
Headache1000500
Abbreviation: RCC, renal cell carcinoma.
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 less than 10% (any grade) were alopecia (8% versus less than 1%), chest pain (5% versus 1%), dysgeusia (altered taste) (8% versus less than 1%), dyspepsia (5% versus less than 1%), dysphonia (4% versus less than 1%), facial edema (1% versus 0%), palmar-plantar erythrodysesthesia (hand-foot syndrome) (6% versus less than 1%), proteinuria (9% versus 0%), rash (8% versus 3%), skin depigmentation (3% versus 0%), and weight decreased (9% versus 3%).

Additional adverse reactions from other clinical trials in RCC patients treated with VOTRIENT are listed below:

Musculoskeletal and Connective Tissue Disorders: Arthralgia, muscle spasms.

Table 2 presents the most common laboratory abnormalities occurring in greater than 10% of patients who received VOTRIENT and more commonly (greater than or equal to 5%) in patients who received VOTRIENT versus placebo.

Table 2: Selected Laboratory Abnormalities Occurring in Greater Than 10% of Patients with RCC Who Received VOTRIENT and More Commonly (Greater Than or Equal to 5%) in Patients Who Received VOTRIENT Versus Placebo

ParametersVOTRIENT
(N = 290)
Placebo
(N = 145)
All Gradesa %Grade 3 %Grade 4 %All Gradesa %Grade 3 %Grade 4 %
Hematologic
Leukopenia3700600
Neutropenia341< 1600
Thrombocytopenia32< 1< 150< 1
Lymphocytopenia314< 12410
Chemistry
ALT increased531022210
AST increased537< 119< 10
Glucose increased41< 103310
Total bilirubin increased363< 1101< 1
Phosphorus decreased34401100
Sodium decreased31412440
Magnesium decreased26< 111400
Glucose decreased170< 1300
Abbreviation: ALT, alanine aminotransferase; AST, aspartate aminotransferase; RCC, renal cell carcinoma.
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.

Soft Tissue Sarcoma

The safety of VOTRIENT has been evaluated in 382 patients with advanced soft tissue sarcoma, with a median duration of treatment of 3.6 months (range, 0 to 53). The most commonly observed adverse reactions (greater than or equal to 20%) in the 382 patients were fatigue, diarrhea, nausea, decreased weight, hypertension, decreased appetite, vomiting, tumor pain, hair color changes, musculoskeletal pain, headache, dysgeusia, dyspnea, and skin hypopigmentation.

The data described below reflect the safety profile of VOTRIENT in 240 patients who participated in a randomized, double-blind, placebo-controlled trial [see Clinical Studies]. The median duration of treatment was 4.5 months (range, 0 to 24) for patients who received VOTRIENT and 1.9 months (range, 0 to 24) for the placebo arm. Fifty-eight percent of patients on VOTRIENT required a dose interruption. Thirty-eight percent of patients on VOTRIENT had their dose reduced. Seventeen percent of patients who received VOTRIENT discontinued therapy due to adverse reactions. Table 3 presents the most common adverse reactions occurring in greater than or equal to 10% of patients who received VOTRIENT.

Table 3: Adverse Reactions Occurring in Greater Than or Equal to 10% of Patients with STS Who Received VOTRIENT

Adverse ReactionsVOTRIENT
(N = 240)
Placebo
(N = 123)
All Gradesa %Grade 3 %Grade 4 %All Gradesa %Grade 3 %Grade 4 %
Fatigue651314841
Diarrhea59501510
Nausea56302220
Weight decreased48401500
Hypertension4270600
Appetite decreased40601900
Hair color changes3900200
Vomiting33301110
Tumor pain29802172
Dysgeusia2800300
Headache2310800
Musculoskeletal pain23202020
Myalgia2320900
Gastrointestinal pain2330940
Dyspnea205< 11751
Exfoliative rash18< 10900
Cough17< 1012< 10
Peripheral edema1420920
Mucositis1220200
Alopecia1200100
Dizziness1110400
Skin disorderb1120100
Skin hypopigmentation1100000
Stomatitis11< 10300
Chest pain1020600
Abbreviation: STS, soft tissue sarcoma.
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.
b 27 of the 28 cases of skin disorder were palmar-plantar erythrodysesthesia.

Other adverse reactions observed more commonly in patients treated with VOTRIENT that occurred in greater than or equal to 5% of patients and at an incidence of more than 2% difference from placebo included insomnia (9% versus 6%), hypothyroidism (8% versus 0%), dysphonia (8% versus 2%), epistaxis (8% versus 2%), left ventricular dysfunction (8% versus 4%), dyspepsia (7% versus 2%), dry skin (6% versus less than 1%), chills (5% versus 1%), vision blurred (5% versus 2%), and nail disorder (5% versus 0%).

Table 4 presents the most common laboratory abnormalities occurring in greater than 10% of patients who received VOTRIENT and more commonly (greater than or equal to 5%) in patients who received VOTRIENT versus placebo.

Table 4: Selected Laboratory Abnormalities Occurring in Greater Than 10% of Patients with STS Who Received VOTRIENT and More Commonly (≥ 5%) in Patients Who Received VOTRIENT Versus Placebo

ParametersVOTRIENT
(N = 240)
Placebo
(N = 123)
All Gradesa %Grade 3 %Grade 4 %All Gradesa %Grade 3 %Grade 4 %
Hematologic
Leukopenia44101500
Lymphocytopeni a431003692
Thrombocytopeni a3631600
Neutropenia3340700
Chemistry
AST increased51532220
ALT increased46821821
Glucose increased45< 103520
Albumin decreased34102100
Alkaline phosphatase increased32302310
Sodium decreased31402030
Total bilirubin increased2910720
Potassium increased16101100
Abbreviation: ALT, alanine aminotransferase; AST, aspartate aminotransferase; STS, soft tissue sarcoma.
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.

Diarrhea

Diarrhea occurred frequently and was predominantly mild-to-moderate in severity in both the RCC and STS clinical trials. 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.

Lipase Elevations

In a single-arm RCC trial, increases in lipase values were observed for 27% (48/181) of patients. Elevations in lipase as an adverse reaction were reported for 4% (10/225) of patients and were Grade 3 for 6 patients and Grade 4 for 1 patient. In the RCC trials of VOTRIENT, clinical pancreatitis was observed in less than 1% (4/586) of patients.

Pneumothorax

Two of 290 patients treated with VOTRIENT and no patient on the placebo arm in the randomized RCC trial developed a pneumothorax. In the randomized trial of VOTRIENT for the treatment of STS, pneumothorax occurred in 3% (8/240) of patients treated with VOTRIENT and in no patients on the placebo arm.

Bradycardia

In the randomized trial of VOTRIENT for the treatment of RCC, bradycardia based on vital signs (less than 60 beats per minute) was observed in 19% (52/280) of patients treated with VOTRIENT and in 11% (16/144) of patients on the placebo arm. Bradycardia was reported as an adverse reaction in 2% (7/290) of patients treated with VOTRIENT compared with less than 1% (1/145) of patients treated with placebo. In the randomized trial of VOTRIENT for the treatment of STS, bradycardia based on vital signs (less than 60 beats per minute) was observed in 19% (45/238) of patients treated with VOTRIENT and in 4% (5/121) of patients on the placebo arm. Bradycardia was reported as an adverse reaction in 2% (4/240) of patients treated with VOTRIENT compared with less than 1% (1/123) of patients treated with placebo.

Adverse Reactions In East Asian Patients

In an analysis of pooled clinical trials (N = 1938) with VOTRIENT, Grade 3 and Grade 4 adverse reactions were observed more frequently in patients of East Asian descent than in patients of non-East Asian descent for neutropenia (12% versus 2%), thrombocytopenia (6% versus less than 1%), and palmar-plantar erythrodysethesia syndrome (6% versus 2%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of VOTRIENT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: Polycythemia

Eye Disorders: Retinal detachment/tear

Gastrointestinal Disorders: Pancreatitis

Metabolic and Nutrition Disorder: Tumor Lysis Syndrome (including fatal cases) [see WARNINGS AND PRECAUTIONS]

Vascular Disorders: Arterial (including aortic) aneurysms, dissections, and rupture

Read the entire FDA prescribing information for Votrient (Pazopanib Tablets)

Related Resources for Votrient

Related Health

Read the Votrient User Reviews »

© Votrient Patient Information is supplied by Cerner Multum, Inc. and Votrient Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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