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What the label lists and what reports show

Pazopanib side effects

Pazopanib's FDA label: “The most common adverse reactions in patients with RCC (≥ 20%) are diarrhea, hypertension, hair color changes (depigmentation), nausea, anorexia, and vomiting.” FAERS holds 26,904 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (3,606 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the pazopanib FDA label on DailyMed (effective December 16, 2025, Novartis Pharmaceuticals Corporation); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of VOTRIENT?

VOTRIENT may cause serious side effects, including: See “What is the most important information I should know about VOTRIENT?” irregular or fast heartbeat or fainting heart failure. This is a condition where your heart does not pump as well as it should and may cause you to have shortness of breath. bleeding problems. These bleeding problems may be severe and cause death. Symptoms may include: unusual bleeding, bruising, or wounds that do not heal. heart attack or stroke. Heart attack and stroke can happen with VOTRIENT and may cause death. Symptoms may include: chest pain or pressure, pain in your arms, back, neck or jaw, shortness of breath, numbness or weakness on one side of your body, trouble talking, headache, or dizziness. blood clots. Blood clots may form in a vein, especially in your legs (deep vein thrombosis or DVT). […]

Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective December 16, 2025 (SPL set eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

The most common adverse reactions in patients with RCC (≥ 20%) are diarrhea, hypertension, hair color changes (depigmentation), nausea, anorexia, and vomiting.

Table 5. Adverse Reactions (≥ 10%) in Patients with STS Who Received VOTRIENT in VEG110727

Adverse reactionsAll Grades a %Grade 3 %Grade 4 %All Grades a %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 disorder b1120100
Skin hypopigmentation1100000
Stomatitis11< 10300
Chest pain1020600

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following clinically significant adverse reactions are elsewhere in the labeling: Hepatic Toxicity [see Warnings and Precautions (5.1)] QT Prolongation and Torsades de Pointes [see Warnings and Precautions (5.2)] Cardiac Dysfunction [see Warnings and Precautions (5.3)] Hemorrhagic Events [see Warnings and Precautions (5.4)] Arterial Thromboembolic Events [see Warnings and Precautions (5.5)] Venous Thromboembolic Events [see Warnings and Precautions (5.6)] Thrombotic Microangiopathy (TMA) [see Warnings and Precautions (5.7)] Gastrointestinal Perforation and Fistula [see Warnings and Precautions (5.8)] Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions (5.9)] Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.10)] Hypertension [see Warnings and Precautions (5.11)] Hypothyroidism [see Warnings and Precautions (5.13)] Proteinuria [see Warnings and Precautions (5.14)] Tumor Lysis Syndrome [see Warnings and Precautions (5.15)] Infection [see Warnings and Precautions (5.16)] The most common adverse reactions in patients with RCC (≥ 20%) are diarrhea, hypertension, hair color changes (depigmentation), nausea, anorexia, and vomiting. …

Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective December 16, 2025 (SPL set eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7), via openFDA; the full label on DailyMed

What do FAERS reports show?

26,904 reports list pazopanib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6,943 are coded as a death and 6,031 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Death (an outcome recorded in the report)4,579
  • Diarrhoea (named in the label)3,606
  • Fatigue (named in the label)2,490
  • Nausea (named in the label)2,419
  • Malignant Neoplasm Progression1,671
  • Drug Ineffective (a use or a product term, not a reaction)1,487
  • Decreased Appetite (named in the label)1,438
  • Vomiting (named in the label)1,405
  • Hypertension (named in the label)1,263
  • Disease Progression (a use or a product term, not a reaction)1,013
  • Asthenia (named in the label)932
  • Malaise903
  • Weight Decreased (named in the label)882
  • Dyspnoea (named in the label)845
  • Hair Colour Changes832
  • Blood Pressure Increased786
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)764
  • Headache (named in the label)717
  • Pain677
  • Abdominal Pain (named in the label)518
  • Pyrexia509
  • Dysgeusia (named in the label)504
  • Rash (named in the label)499
  • Abdominal Pain Upper490
  • Off Label Use (a use or a product term, not a reaction)468

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Pazopanib: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions