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Sunitinib

Sunitinib is a kinase inhibitor (a targeted cancer medicine) taken by mouth for gastrointestinal stromal tumor (GIST), kidney cancer (renal cell carcinoma), and pancreatic neuroendocrine tumors.

Brand names SutentSunitinib Malate
Drug classes Kinase Inhibitor
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 10 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Recall on record
Sunitinib at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Sunitinib (Sutent) is a specialist targeted cancer medicine, on the market since about 2006 and available generically, that blocks signals tumors use to grow and build new blood vessels, for advanced kidney cancer, certain pancreatic neuroendocrine tumors, and GIST (a digestive tract tumor) after imatinib. It can be tough to tolerate, and most people notice tiredness, diarrhea, mouth sores, or sore palms and soles (hand-foot syndrome). The key risk is its boxed warning of severe, sometimes fatal liver damage, so report yellow skin or eyes, dark urine, or severe stomach pain promptly. It can also raise blood pressure and weaken the heart, so expect regular liver tests and blood pressure checks.

Clinical pearls

  • Have every new prescription checked against it, because strong CYP3A4 inhibitors raise sunitinib levels and strong inducers lower them.
  • Some cancers use a four-weeks-on, two-weeks-off schedule, so mark the break weeks on a calendar to avoid dosing through them.
  • Tell your dentist and any surgeon you take it, since it can cause jaw bone damage and slow wound healing.
  • If you use diabetes medicines, check your sugar more often, because sunitinib can cause low blood sugar and doses may need lowering.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Sunitinib can cause severe liver damage, which in some cases has been fatal. Your liver function should be checked with blood tests before treatment, during each cycle, and when needed. Depending on what the tests show, your prescriber may pause the medicine, lower the dose, or stop it. Call your doctor right away if you notice yellowing of your skin or eyes, dark urine, or severe stomach pain.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule
Earliest FDA record2006
Companies listing it with the FDA10
FDA label last updatedFeb 20, 2026
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Sunitinib, written from its FDA label.

What Sunitinib is used for

▾

Sunitinib is a targeted cancer medicine used in adults for these conditions (sunitinib malate capsules and Sutent capsules share the same uses):

  • Gastrointestinal stromal tumor (GIST) after progression on, or intolerance to, imatinib mesylate
  • Advanced renal cell carcinoma (RCC)
  • Adjuvant treatment of RCC in adults at high risk of recurrence after nephrectomy
  • Progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) that are unresectable and locally advanced or metastatic

How Sunitinib works

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Sunitinib blocks several receptor tyrosine kinases, which are proteins that act like on-switches for cell growth. These include PDGFR, VEGFR, KIT, FLT3, CSF-1R, and RET.

Blocking these signals can slow tumor growth, cut off the new blood vessels tumors rely on, and limit spread. Its main active byproduct (metabolite) works about as strongly as the drug itself.

Sunitinib dosage

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Sunitinib malate capsules and Sutent capsules are taken by mouth once daily, with or without food.

  • For GIST and advanced RCC, the usual schedule is 4 weeks on followed by 2 weeks off, repeated until the disease progresses or side effects become unacceptable.
  • For adjuvant RCC, the same 4-on, 2-off schedule is used for nine 6-week cycles.
  • For pNET, it is taken once daily without a planned break until the disease progresses or side effects become unacceptable.

Your prescriber may lower the dose or pause treatment for side effects. Follow your prescriber and pharmacy label.

Dosing details from the FDA-approved label

From the Sunitinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • GIST and advanced RCC
    • 50 mg taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2) until disease progression or unacceptable toxicity
    • May be taken with or without food
  • Adjuvant treatment of RCC
    • 50 mg taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2), for nine 6-week cycles
    • Maximum: 9 cycles
    • May be taken with or without food
  • pNET
    • 37.5 mg taken orally once daily until disease progression or unacceptable toxicity
    • May be taken with or without food
  • End-stage renal disease patients on hemodialysis
    • No starting dose adjustment is required
    • Subsequent doses may be increased gradually up to 2-fold based on safety and tolerability
    • Maximum: up to 2-fold increase
    • Decreased exposure compared to patients with normal renal function
  • Coadministration with strong CYP3A4 inhibitors (GIST and RCC)
    • If coadministration cannot be avoided, consider a dose reduction to a minimum of 37.5 mg orally once daily, on Schedule 4/2
    • Select an alternate concomitant medication with no or minimal enzyme inhibition potential
  • Coadministration with strong CYP3A4 inhibitors (pNET)
    • If coadministration cannot be avoided, consider a dose reduction to a minimum of 25 mg orally once daily
    • Select an alternate concomitant medication with no or minimal enzyme inhibition potential
  • Coadministration with strong CYP3A4 inducers (GIST and RCC)
    • If coadministration cannot be avoided, consider a dose increase to a maximum of 87.5 mg orally once daily, on Schedule 4/2
    • Maximum: 87.5 mg once daily
    • Monitor patients carefully for adverse reactions
  • Coadministration with strong CYP3A4 inducers (pNET)
    • If coadministration cannot be avoided, consider a dose increase to a maximum of 62.5 mg orally once daily
    • Maximum: 62.5 mg once daily
    • Monitor patients carefully for adverse reactions
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION GIST and Advanced RCC : • The recommended dosage is 50 mg orally once daily for the first 4 weeks of each 6-week cycle (Schedule 4/2). ( 2.1 ) Adjuvant Treatment of RCC : • The recommended dosage is 50 mg orally once daily for the first 4 weeks of a 6-week cycle (Schedule 4/2) for a maximum of 9 cycles. ( 2.2 ) pNET : • The recommended dosage is 37.5 mg orally once daily. ( 2.3 ) 2.1 Recommended Dosage for GIST and Advanced RCC The recommended dosage of sunitinib malate capsules for gastrointestinal stromal tumor (GIST) and advanced renal cell carcinoma (RCC) is 50 mg taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2) until disease progression or unacceptable toxicity. Sunitinib malate capsules may be taken with or without food. 2.2 Recommended Dosage for Adjuvant Treatment of RCC The recommended dosage of sunitinib malate capsules for the adjuvant treatment of RCC is 50 mg taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off (Schedule 4/2), for nine 6-week cycles. Sunitinib malate capsules may be taken with or without food. 2.3 Recommended Dosage for pNET The recommended dosage of sunitinib malate capsules for pancreatic neuroendocrine tumors (pNET) is 37.5 mg taken orally once daily until disease progression or unacceptable toxicity. Sunitinib malate capsules may be taken with or without food. 2.4 Dosage Modifications for Adverse Reactions To manage adverse reactions, the recommended dosage modifications are provided in Table 1. Table 2 provides the recommended dosage reductions of sunitinib malate capsules for adverse reactions . Table 1. Recommended Dosage Reductions of Sunitinib Malate Capsules for Adverse Reactions Indications GIST RCC pNET Advanced RCC Adjuvant RCC First dose reduction 37.5 mg once daily 37.5 mg once daily 37.5 mg once daily 25 mg once daily Second dose reduction 25 mg once daily 25 mg once daily NA NA Table 2. Recommended Dosage Modifications for Sunitinib Malate Capsules for Adverse Reactions Adverse Reaction Severity Dosage Modifications for Sunitinib Malate Capsules Hepatotoxicity [see Warnings and Precautions (5.1) ] Grade 3 • Withhold until resolution to Grade 0 to 1 or baseline. • Resume at a reduced dose. • For recurring Grade 3 permanently discontinue. Grade 4 • Permanently discontinue.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Sunitinib side effects

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The most common side effects (seen in at least 1 in 4 people) include:

Common side effects

  • Tiredness or weakness
  • Diarrhea
  • Mouth sores or soreness (mucositis/stomatitis)
  • Nausea and vomiting
  • Decreased appetite
  • Abdominal pain
  • Hand-foot syndrome (skin problems on palms and soles)
  • High blood pressure
  • Abdominal pain and indigestion
  • Bleeding events
  • Altered taste
  • Low platelet counts (thrombocytopenia)

When to get medical help

  • Yellow skin or eyes, dark urine, or severe stomach pain, which can signal liver problems
  • Shortness of breath, swelling, chest pain, or a very fast or irregular heartbeat or fainting
  • Severe or sudden bleeding, coughing up blood, or black stools
  • Severe headache, confusion, changes in alertness, or vision loss
  • Severe skin reactions such as widespread blistering or peeling, or painful, spreading skin infection
  • Symptoms of low blood sugar, such as fainting or confusion
  • Jaw pain or problems after dental work
  • Wounds that are not healing

Sunitinib warnings and precautions

▾
  • Liver damage (boxed warning): can be severe or fatal. Liver tests are checked regularly.
  • Heart problems: heart failure, heart attack, and weakened pumping have occurred. Watch for swelling and shortness of breath.
  • QT prolongation: a heart rhythm change that can lead to dangerous arrhythmias. Higher-risk patients may need ECGs and electrolyte checks.
  • High blood pressure: common. Blood pressure is monitored and treated.
  • Bleeding: some fatal, including in the stomach, lungs, tumor, and brain.
  • Other serious risks: tumor lysis syndrome, kidney and blood vessel damage, protein in urine, severe skin reactions, RPLS, thyroid changes, low blood sugar, jaw bone damage, and slow wound healing.
  • Surgery and dental work: treatment is held for at least 3 weeks before elective surgery or invasive dental procedures.

Sunitinib interactions

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Other medicines can change sunitinib levels or add to its risks.

  • Strong CYP3A4 inhibitors may raise sunitinib levels, so a different medicine or lower dose may be needed.
  • Strong CYP3A4 inducers may lower sunitinib levels, so a different medicine or higher dose may be considered.
  • QT-prolonging medicines add to the heart rhythm risk and call for more ECG monitoring.
  • Diabetes medicines may need adjusting because of the risk of low blood sugar.
  • Sunitinib is not approved in combination with bevacizumab.

Interactions listed in the FDA-approved label

From the Sunitinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A4 inhibitors: Co-administration may increase sunitinib plasma concentrations. Select an alternate concomitant medication with no or minimal enzyme inhibition potential; consider a dose reduction of sunitinib if co-administered.
  • Strong CYP3A4 inducers: Co-administration may decrease sunitinib plasma concentrations. Select an alternate concomitant medication with no or minimal enzyme induction potential; consider a dose increase of sunitinib if it must be co-administered.
  • Drugs that prolong QT interval: Sunitinib is associated with QTc interval prolongation. Monitor the QT interval with ECGs more frequently in patients who require concomitant medications known to prolong the QT interval.
Read the label’s full interactions text

7 DRUG INTERACTIONS • CYP3A4 Inhibitors : Consider dose reduction of sunitinib malate capsules when administered with strong CYP3A4 inhibitors. ( 7.1 ) • CYP3A4 Inducers : Consider dose increase of sunitinib malate capsules when administered with strong CYP3A4 inducers. ( 7.1 ) 7.1 Effect of Other Drugs on Sunitinib Malate Capsules Strong CYP3A4 Inhibitors Co-administration with strong CYP3A4 inhibitors may increase sunitinib plasma concentrations [see Clinical Pharmacology (12.3) ] . Select an alternate concomitant medication with no or minimal enzyme inhibition potential. Consider a dose reduction for sunitinib malate capsules when it is co-administered with strong CYP3A4 inhibitors [see Dosage and Administration (2.5) ] . Strong CYP3A4 Inducers Co-administration with strong CYP3A4 inducers may decrease sunitinib plasma concentrations [see Clinical Pharmacology (12.3) ]. Select an alternate concomitant medication with no or minimal enzyme induction potential. Consider a dose increase for sunitinib malate capsules when it must be co-administered with CYP3A4 inducers [see Dosage and Administration (2.5) ] . 7.2 Drugs that Prolong QT Interval Sunitinib malate capsules are associated with QTc interval prolongation [see Warnings and Precautions (5.3) , Clinical Pharmacology (12.2) ] . Monitor the QT interval with ECGs more frequently in patients who require treatment with concomitant medications known to prolong the QT interval.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿138 supplements and herbs with documented Sunitinib interactions, ranked by severity Check Sunitinib against a supplement or herb →

Before taking Sunitinib

▾
  • Tell your care team about liver, heart, blood pressure, thyroid, kidney, or bleeding problems, and about diabetes.
  • Tell them about all medicines you take, including heart rhythm medicines.
  • Pregnancy: sunitinib can cause fetal harm. Pregnancy status should be verified before starting.
  • Use effective contraception during treatment and at least 4 weeks after the last dose (females), or 7 weeks (males with female partners).
  • Do not breastfeed during treatment and for at least 4 weeks after the last dose.
  • It may impair male and female fertility.
  • Safety and effectiveness in children have not been established.
  • Adults 65 and older had more severe (Grade 3 or 4) side effects than younger adults.
  • No dose change is needed for mild or moderate liver impairment. It has not been studied in severe liver impairment.

Sunitinib overdose

▾

There is no specific antidote for sunitinib overdose. Treatment is general supportive care, and removing unabsorbed drug may be considered. Accidental overdoses have caused side effects consistent with the known safety profile, or none. Seek urgent medical help if you take too much.

What Sunitinib does in the body

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Sunitinib's effect on the body is tied to how much drug is in the blood, for both benefits and side effects. It can lengthen the QT interval (a measure of heart rhythm timing) in a dose-dependent way. This may raise the risk of dangerous rhythms, including Torsade de Pointes.

How your body processes Sunitinib

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After a dose by mouth, sunitinib peaks in the blood in about 6 to 12 hours. A high-fat meal did not meaningfully change drug exposure. The body builds up steady levels within 10 to 14 days of daily use.

It is broken down mainly by the liver enzyme CYP3A4 into an active metabolite. The half-life is roughly 40 to 60 hours for sunitinib and 80 to 110 hours for the metabolite. Most of the drug leaves in feces, with a smaller share in urine.

How to store Sunitinib

▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

138

Supplements & herbs that interact with Sunitinib

138 supplements and herbal products have documented interactions with Sunitinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 3
  • Moderate · 94
  • Minor · 41
ACTIVATED CHARCOAL Major GRAPEFRUIT Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate AMERICAN ELDER Moderate ASTAXANTHIN Moderate +130 more
Every supplement checked against Sunitinib — ranked by severity The full interaction hub: 3 major · 94 moderate · 41 minor · every one linked to its full report. Check Sunitinib against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Sunitinib: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Sunitinib — the kind of thing our pharmacy team would talk through with you at the counter.

What is sunitinib used for?

▾
Sunitinib treats certain cancers in adults. These are GIST after imatinib, advanced kidney cancer (renal cell carcinoma), kidney cancer at high risk of coming back after surgery, and certain pancreatic neuroendocrine tumors. Your doctor will tell you which applies to you.

How do I take it?

▾
Take your capsule by mouth once a day, with or without food. For some cancers you take it for 4 weeks and then stop for 2 weeks. For others it is daily with no break. Follow your prescriber's schedule exactly.

What side effects should I expect?

▾
Tiredness, diarrhea, nausea, mouth sores, loss of appetite, altered taste, and sore palms and soles are common. High blood pressure and nosebleeds or other bleeding can also occur. Tell your care team about these so they can help manage them.

When should I call my doctor right away?

▾
Call if you notice yellow skin or eyes, dark urine, chest pain, shortness of breath, swelling, fainting, serious bleeding, severe skin blistering or peeling, or a severe headache with confusion or vision changes. Sunitinib can cause serious liver and heart problems, so don't wait on these.

Are there medicines I should avoid with it?

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Some medicines change how much sunitinib is in your body, especially strong CYP3A4 inhibitors and inducers. Medicines that affect heart rhythm also matter. Always show me or your doctor your full medicine list, including diabetes medicines.

Is it safe in pregnancy?

▾
No. Sunitinib can harm an unborn baby. You should use effective contraception during treatment and for at least 4 weeks after your last dose, or 7 weeks for men with female partners. Don't breastfeed during treatment and for at least 4 weeks after.

Is Sunitinib available over the counter?

▾
No. Sunitinib is a prescription medicine: every Sunitinib product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Sunitinib first available?

▾
The earliest FDA record we hold for Sunitinib is from 2006: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Sunitinib was first used.

Who makes Sunitinib?

▾
10 companies currently list Sunitinib products in the FDA's NDC Directory, including Aurobindo Pharma Limited, AvKARE, Dr.Reddys Laboratories Inc. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Sunitinib on HelloPharmacist

📊Sunitinib supplement interactions138 checked — ranked by severity 🌿Drug & Supplement CheckerSunitinib vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Sunitinib NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Sunitinib Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Sunitinib forms and strengths (how it comes)

Sunitinib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Sunitinib Malate Sutent
How this form is used
What it may be used for
  • Sunitinib malate capsules and Sutent are used for GIST after imatinib, advanced RCC, adjuvant RCC after nephrectomy in high-risk patients, and progressive pNET.
Important instructions
  • Sunitinib malate capsules and Sutent are taken by mouth once daily, with or without food.
  • Sunitinib malate capsules and Sutent are taken on a 4-weeks-on, 2-weeks-off schedule for GIST and RCC, while for pNET they are taken daily as directed by your prescriber.
Available strengths 4 strengths
12.5 mg 25 mg 37.5 mg 50 mg
72 FDA-listed product records ⓘ

Sunitinib on the U.S. market: products, makers and brands

How Sunitinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

10 companies list 40 Sunitinib product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2006. Brand names on the directory include Sutent, Sunitinib Malate; the rest are generics.

1
Dose forms ⓘ
10
Labelers (makers, repackagers, distributors)
2
Brand names
40
FDA-listed product records ⓘ
2006
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (8) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Aurobindo Pharma Limited10%
AvKARE10%
Dr.Reddys Laboratories Inc10%
Mylan Pharmaceuticals Inc.10%
NorthStar RxLLC10%
Novadoz Pharmaceuticals LLC10%
Other makers40%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Sunitinib is used (Medicaid data)

A general measure of how commonly Sunitinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Sunitinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

39
Medicaid prescriptions filled (Q1–Q4 2025)
$579,983 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Sunitinib prescribed? Of the 1,601 medications we measure, Sunitinib ranks #1,552 by Medicaid prescriptions — more than 3% of them.

Where Sunitinib ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,552 of 1,601
#1,547 Fludarabine Injection 44 Rx #1,548 Brolucizumab-dbll Inje... 43 Rx #1,549 Cobicistat 42 Rx #1,550 Luliconazole Topical 41 Rx #1,551 Plerixafor Injection 40 Rx #1,552 Sunitinib 39 Rx #1,553 Isavuconazonium Inject... 39 Rx #1,554 Mycophenolate Injectio... 39 Rx #1,555 Apomorphine Injection 38 Rx #1,556 Larotrectinib 38 Rx #1,557 Vitamin A 38 Rx

Utilization by Sunitinib product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 25 mg oral capsule is the most-dispensed Sunitinib product — about 62% of these Medicaid prescriptions.

sunitinib 25 MG Oral Capsule Most dispensed

24 Medicaid prescriptions (Q1–Q4 2025) 62% of Sunitinib prescriptions shown $289,267 gross reimbursement (before rebates) ≈ $12,053 per prescription (gross)

Summed across the 1 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 616285

sunitinib 37.5 MG Oral Capsule

15 Medicaid prescriptions (Q1–Q4 2025) 38% of Sunitinib prescriptions shown $290,715 gross reimbursement (before rebates) ≈ $19,381 per prescription (gross)

Summed across the 1 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1541890

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Sunitinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 30 listed Sunitinib NDCs with Medicaid activity.

Compare Sunitinib products

A representative set of FDA-listed product records for Sunitinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 40 of 40 products — FDA National Drug Code Directory. See every product, package size and price: browse all 40 Sunitinib NDCs →

Sunitinib recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 2 Sunitinib recalls since July 2021, covering 3 product listings. One of them is still ongoing and is listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Oct 18, 2024 · AvKARE
Labeling: Label Mix-Up
  • Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28 Lots: Lot #: 100049501, Exp. Date 07/31/2026 FDA record D-0104-2025 →
  • Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28 Lots: Lot #: 100049371, Exp. Date 07/31/2026 FDA record D-0103-2025 →
Class II Jul 5, 2023 · Terminated · Teva Pharmaceuticals USA Inc
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
  • Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28 Lots: Lot # 100037220, Exp 10/2024 FDA record D-0913-2023 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Sunitinib RxCUI 357977 1 dose form · 4 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 616278 In current FDA listings
    Clinical drug / strength (SCD) 12.5 MG RxCUI 616279 25 MG RxCUI 616285 37.5 MG RxCUI 1541890 50 MG RxCUI 616289

Look up RxCUI 357977 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Sunitinib costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Feb 21, 2024). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Capsule · Oral 12.5 mg $222.41 per capsule NDC details & price history
Capsule · Oral 25 mg $449.06 per capsule NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Sunitinib brand names

Sunitinib is sold under 2 brand names in the FDA directory — Sutent, Sunitinib Malate. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Sutent Sunitinib Malate

Who makes Sunitinib: manufacturers and labelers

10 companies list Sunitinib products with the FDA. By number of product records, the largest are Aurobindo Pharma Limited, AvKARE, Dr.Reddys Laboratories Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Aurobindo Pharma Limited 4 AvKARE 4 Dr.Reddys Laboratories Inc 4 Mylan Pharmaceuticals Inc. 4 NorthStar RxLLC 4 Novadoz Pharmaceuticals LLC 4 Novugen Pharma (USA) LLC. 4 Pfizer Laboratories Div Pfizer Inc 4 Sun Pharmaceutical Industries Inc. 4 Teva Pharmaceuticals USA, Inc. 4

Sunitinib drug class (RxNorm)

Sunitinib belongs to the Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) Other protein kinase inhibitors
How it works Protein Kinase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Sunitinib page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 20, 2026
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Sunitinib.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Sunitinib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
10
Finished products in the current FDA directory
40
Companies listing them (makers, repackagers, distributors)
10
FDA labeler codes behind them ⓘ
10
Linked representative label ⓘ
Pfizer Laboratories Div Pfizer Inc
Linked label effective
Feb 20, 2026
Composite sections available
25
Linked SPL Set ID
43a4d7f8-48ae-4a63-9108-2fa8e3ea9d9c
Linked SPL Document ID
530eef58-b5ab-49f1-8d73-a2dae0356f24
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Pfizer Laboratories Div Pfizer Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →