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Votrient

"Investigators in The Cancer Genome Atlas (TCGA) Research Network have uncovered a connection between how tumor cells use energy from metabolic processes and the aggressiveness of the most common form of kidney cancer, clear cell renal cell carcin"...

Votrient

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

SIDE EFFECTS: See also Warning section.

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 right away if you have any serious side effects, including: 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), change in the amount of urine, 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.

Get medical help right away if you have any very serious side effects, including: 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, get medical help right away 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:

Renal Cell Carcinoma

The safet y 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 ( ≥ 20%) in the 586 patients were diarrhea, hypertension, hair color change, nausea, fatigue, anorexia, and vomiting.

The data described below reflect the safet y 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 ≥ 10% of patients who received VOTRIENT.

Table 1: Adverse Reactions Occurring in ≥ 10% of Patients With RCC 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
aNational 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%), dysphonia (4% 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%).

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 > 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 With RCC 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
Thrombocytopenia 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
aNational 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 ( ≥ 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 ≥ 10% of patients who received VOTRIENT.

Table 3: Adverse Reactions Occurring in ≥ 10% of Patients With STS who Received VOTRIENT

Adverse Reactions VOTRIENT
(N = 240)
Placebo
(N = 123)
All Gradesa
%
Grade 3
%
Grade 4
%
All Gradesa
%
Grade 3
%
Grade 4
%
Fatigue 65 13 1 48 4 1
Diarrhea 59 5 0 15 1 0
Nausea 56 3 0 22 2 0
Weight decreased 48 4 0 15 0 0
Hypertension 42 7 0 6 0 0
Appetite decreased 40 6 0 19 0 0
Hair color changes 39 0 0 2 0 0
Vomiting 33 3 0 11 1 0
Tumor pain 29 8 0 21 7 2
Dysgeusia 28 0 0 3 0 0
Headache 23 1 0 8 0 0
Musculoskeletal pain 23 2 0 20 2 0
Myalgia 23 2 0 9 0 0
Gastrointestinal pain 23 3 0 9 4 0
Dyspnea 20 5 < 1 17 5 1
Exfoliative rash 18 < 1 0 9 0 0
Cough 17 < 1 0 12 < 1 0
Peripheral edema 14 2 0 9 2 0
Mucositis 12 2 0 2 0 0
Alopecia 12 0 0 1 0 0
Dizziness 11 1 0 4 0 0
Skin disorderb 11 2 0 1 0 0
Skin hypopigmentation 11 0 0 0 0 0
Stomatitis 11 < 1 0 3 0 0
Chest pain 10 2 0 6 0 0
aNational Cancer Institute Common Terminology Criteria for Adverse Events, version 3.
b27 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 ≥ 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 < 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 > 10% of patients who received VOTRIENT and more commonly ( ≥ 5%) in patients who received VOTRIENT versus placebo.

Table 4: Selected Laboratory Abnormalities Occurring in > 10% of Patients With STS who Received VOTRIENT and More Commonly ( ≥ 5%) in Patients who Received VOTRIENT Versus Placebo

Parameters VOTRIENT
(N = 240)
Placebo
(N = 123)
All Gradesa
%
Grade 3
%
Grade 4
%
All Gradesa
%
Grade 3
%
Grade 4
%
Hematologic
  Leukopenia 44 1 0 15 0 0
  Lymphocytopenia 43 10 0 36 9 2
  Thrombocytopenia 36 3 1 6 0 0
  Neutropenia 33 4 0 7 0 0
Chemistry
  AST increased 51 5 3 22 2 0
  ALT increased 46 8 2 18 2 1
  Glucose increased 45 < 1 0 35 2 0
  Albumin decreased 34 1 0 21 0 0
  Alkaline phosphatase increased 32 3 0 23 1 0
  Sodium decreased 31 4 0 20 3 0
  Total bilirubin increased  29 1 0 7 2 0
  Potassium increased 16 1 0 11 0 0
aNational 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 < 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 ( < 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 to < 1% (1/145) of patients treated with placebo. In the randomized trial of VOTRIENT for the treatment of STS, bradycardia based on vital signs ( < 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 to < 1% (1/123) of patients treated with placebo.

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.

Gastrointestinal Disorders: Pancreatitis

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

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Votrient - User Reviews

Votrient User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Votrient sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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