Prescription medicine
Pazopanib Brand names: Votrient
Pazopanib (Votrient) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 8 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the pazopanib FDA label on DailyMed (effective December 16, 2025, Novartis Pharmaceuticals Corporation); the NDA 22465 record on Drugs@FDA; every pazopanib label on DailyMed.
Highlights of the record
FDA label of December 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
HEPATOTOXICITY.
Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended [see Warnings and Precautions (5.1)]. WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended.
Used for
From the label: indications and usageVOTRIENT is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC).
Forms and strengths
- 200 mg
- 400 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- October 19, 2009 Votrient, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first October 19, 2023; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 8 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2023 0 Class I among all firms' recalls; latest November 20, 2023
- FAERS reports
- 26,904 through July 30, 2026
What is pazopanib used for?
From the label: indications and usageVOTRIENT is a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). ( 1.1 ) advanced soft tissue sarcoma (STS) who have received prior chemotherapy. ( 1.2 ) Limitations of Use: The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. 1.1 Renal Cell Carcinoma VOTRIENT ® is indicated for the treatment of adults with advanced renal cell carcinoma (RCC). 1.2 Soft Tissue Sarcoma VOTRIENT is indicated for the treatment of adults with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. […]
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (VOTRIENT), Novartis Pharmaceuticals Corporation, effective December 16, 2025 (SPL set eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7), via openFDA; the full label on DailyMed
What does the patient leaflet for pazopanib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about VOTRIENT?VOTRIENT can cause severe liver problems, including death. Your healthcare provider will do blood tests to check your liver before you start and while you take VOTRIENT. Tell your healthcare provider right away if you get any of these signs of liver problems during treatment with VOTRIENT: ○ yellowing of your skin or the whites of your eyes (jaundice) ○ loss of appetite ○ dark urine ○ pain on the right side of your stomach area (abdomen) ○ tiredness ○ bruise easily ○ nausea or vomiting Your healthcare provider may need to prescribe a lower dose of VOTRIENT for you or tell you to stop taking VOTRIENT if you develop liver problems during treatment.
From the patient leaflet: How should I store VOTRIENT tablets?Store VOTRIENT at room temperature between 68°F and 77°F (20°C to 25°C). Keep VOTRIENT and all medicines out of the reach of children.
Source: FDA drug label (VOTRIENT), Novartis Pharmaceuticals Corporation, effective December 16, 2025 (SPL set eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7), via openFDA; the full label on DailyMed
Is there a generic for pazopanib (Votrient)?
The FDA approved the first generic pazopanib on October 19, 2023. 6 generic applications are approved; 6 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists pazopanib from 8 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2009 earliest approval on file
- 2023 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has pazopanib been recalled?
The FDA's Enforcement Report lists 1 recall naming pazopanib since 2023: 0 Class I (the most serious), 0 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| November 20, 2023 | Class III | Siegfried Barbera, SL | Failed Dissolution Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pazopanib label say about other medicines?
The pazopanib label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name pazopanib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Bevacizumab | warnings and precautions | Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS), occurred in clinical trials of VOTRIENT as monotherapy, in combination with bevacizumab, and in combination with topotecan. |
| Esomeprazole | drug interactions | Concomitant use of VOTRIENT with esomeprazole, a PPI, decreased the exposure of pazopanib. |
| Pemetrexed | warnings and precautions | Clinical trials of VOTRIENT in combination with pemetrexed and lapatinib were terminated early due to increased toxicity and mortality. |
| Simvastatin | drug interactions | Concomitant use of VOTRIENT with simvastatin increases the risk of alanine aminotransferase (ALT) elevations. |
| Topotecan | warnings and precautions | Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS), occurred in clinical trials of VOTRIENT as monotherapy, in combination with bevacizumab, and in combination with topotecan. |
Source: FDA drug label (VOTRIENT), 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 for pazopanib?
The FDA Adverse Event Reporting System holds 26,904 reports that list pazopanib among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Pazopanib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other