Prescription medicine

Sunitinib Brand names: Sutent

Sunitinib (Sutent) is a prescription medicine with an FDA approval on record since 2006. FDA's NDC Directory lists it from 8 generic labelers.

Generic listed
Boxed warning

Check it at the source: the sunitinib FDA label on DailyMed (effective February 20, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 21938 record on Drugs@FDA; every sunitinib label on DailyMed.

Highlights of the record

FDA label of February 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed warning

HEPATOTOXICITY.

Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ]. WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity may be severe, and in some cases fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue SUTENT as recommended [see Warnings and Precautions (5.1) ].

Used for

From the label: indications and usage
SUTENT is a kinase inhibitor indicated for:
treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate.

Forms and strengths

12.5 mg
25 mg
37.5 mg
50 mg

Capsule.

On the market

Earliest approval on file: January 26, 2006 Sutent, Cppi Cv; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 8 first August 16, 2021; 8 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): 3 since 2023 0 Class I among all firms' recalls; latest October 18, 2024
FAERS reports: 39,092 through July 30, 2026

What is sunitinib used for?

From the label: indications and usage
SUTENT is a kinase inhibitor indicated for:
treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. ( 1.1 )
treatment of adult patients with advanced renal cell carcinoma (RCC). ( 1.2 )
adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. ( 1.3 )
treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. […]

FDA pharmacologic class: Kinase Inhibitor.

Source: FDA drug label (SUTENT), NDA021938 (Cppi Cv), as published by Pfizer Laboratories Div Pfizer Inc, effective February 20, 2026 (SPL set 43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c), via openFDA; the full label on DailyMed

What does the patient leaflet for sunitinib 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 SUTENT?
SUTENT can cause serious side effects including: • Severe liver problems, that can lead to death. Tell your healthcare provider right away if you develop any of the following signs and symptoms of liver problems during treatment with SUTENT: o itching o yellow eyes or skin o dark urine o pain or discomfort in the right upper stomach area Your healthcare provider should do blood tests to check your liver function before you start taking and during treatment with SUTENT. Your healthcare provider may temporarily stop, reduce your dose, or permanently stop treatment with SUTENT if you develop liver problems. See “ What are the possible side effects of SUTENT? ” for more information about side effects.

Is there a generic for sunitinib (Sutent)?

The FDA approved the first generic sunitinib on August 16, 2021. 8 generic applications are approved; 8 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 sunitinib 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.

2006 earliest approval on file
2021 first generic approved
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has sunitinib been recalled?

The FDA's Enforcement Report lists 3 recalls naming sunitinib since 2023: 0 Class I (the most serious), 3 Class II, 0 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
October 18, 2024	Class II	AvKARE	Labeling: Label Mix-Up
July 5, 2023	Class II	Teva Pharmaceuticals USA Inc	Failed Moisture Limits: Water (moisture) content above the approved product specifications.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the sunitinib label say about other medicines?

The sunitinib label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 5 other medicines name sunitinib. 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	… clinical trials and in postmarketing experience of SUTENT as monotherapy and administered in combination with bevacizumab.

Other labels that name sunitinib

Check sunitinib against other medicines

What do FAERS reports show for sunitinib?

The FDA Adverse Event Reporting System holds 39,092 reports that list sunitinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11,666 are coded as a death and 11,523 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

Death (an outcome recorded in the report)7,435
Diarrhoea (named in the label)4,417
Fatigue (named in the label)4,192
Disease Progression (a use or a product term, not a reaction)3,906
Nausea (named in the label)3,121
Asthenia (named in the label)2,461
Decreased Appetite (named in the label)2,316
Vomiting (named in the label)2,211

Side effects: the label's list and every FAERS reaction

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
Sunitinib side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other