Sunitinib: uses, dosing, side effects & brands
Sunitinib is a kinase inhibitor sold in the U.S. under one brand, for renal cell carcinoma, pancreatic neoplasms and neuroendocrine tumors. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Kinase Inhibitor
- Treats
- Renal Cell Carcinoma, Pancreatic Neoplasms and Neuroendocrine Tumors
- Available as
- Capsule
- Sold as
- Sutent
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How sunitinib is dosed
From the FDA label for Sutent (application NDA021938). Other sunitinib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 SUTENT 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. SUTENT may be taken with or without food. 2.2 Recommended Dosage for Adjuvant Treatment of RCC The recommended dosage of SUTENT 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. SUTENT may be taken with or without food. 2.3 Recommended Dosage for pNET The recommended dosage of SUTENT for pancreatic neuroendocrine tumors (pNET) is 37.5 mg taken orally once daily until disease progression or unacceptable toxicity. SUTENT may be taken with or without food. 2.4 Dosage Modifications for Adverse Reactions To manage adverse reactions, the recommended dosage…
Sunitinib side effects
The following clinically significant adverse reactions are described elsewhere in the labeling. • Hepatotoxicity [see Warnings and Precautions (5.1) ] • Cardiovascular Events [see Warnings and Precautions (5.2) ] • QT Interval Prolongation and Torsade de Pointes [see Warnings and Precautions (5.3) ] • Hypertension [see Warnings and Precautions (5.4) ] • Hemorrhagic Events [see Warnings and Precautions (5.5) ] • Tumor Lysis Syndrome [see Warnings and Precautions (5.6) ] • Thrombotic Microangiopathy [see Warnings and Precautions (5.7) ] • Proteinuria [see Warnings and Precautions (5.8) ] • Dermatologic Toxicities [see Warnings and Precautions (5.9) ] • Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.10) ] • Thyroid Dysfunction [see Warnings and Precautions (5.11) ] • Hypoglycemia [see Warnings and Precautions (5.12) ] • Osteonecrosis of the Jaw [see Warnings and Precautions (5.13) ] • Impaired Wound Healing [see Warnings and Precautions (5.14) ] • The most common adverse reactions (≥25%) are fatigue/asthenia, diarrhea, mucositis/stomatitis, nausea, decreased appetite/anorexia, vomiting, abdominal pain, hand-foot syndrome, hypertension, bleeding events, dysgeusia/altered taste, dyspepsia, and thrombocytopenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1…
Who shouldn’t take sunitinib
None. None ( 4 )
Sunitinib drug interactions
CYP3A4 Inhibitors : Consider dose reduction of SUTENT when administered with strong CYP3A4 inhibitors. ( 7.1 ) • CYP3A4 Inducers : Consider dose increase of SUTENT when administered with strong CYP3A4 inducers. ( 7.1 ) 7.1 Effect of Other Drugs on SUTENT 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 SUTENT 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 SUTENT when it must be co-administered with CYP3A4 inducers [see Dosage and Administration (2.5) ] . 7.2 Drugs that Prolong QT Interval SUTENT is 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.
Every sunitinib product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Sutent.
What sunitinib pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| Pfizer;STN;25;mg | 25 mg | orange, brown | capsule | — |
| Pfizer;STN;50;mg | 50 mg | brown | capsule | — |
| Pfizer;STN;37;5;mg | 37.5 mg | yellow | capsule | — |
| TEVA;8199;TEVA;8199 | 12.5 mg | red | capsule | — |
| TEVA;8224;TEVA;8224 | 25 mg | brown, red | capsule | — |
| TEVA;8229;TEVA;8229 | 37.5 mg | yellow | capsule | — |
| TEVA;8231;TEVA;8231 | 50 mg | brown | capsule | — |
| TEVA;8199;TEVA;8199 | 12.5 mg | red | capsule | — |
| TEVA;8224;TEVA;8224 | 25 mg | brown, red | capsule | — |
| TEVA;8229;TEVA;8229 | 37.5 mg | yellow | capsule | — |
| TEVA;8231;TEVA;8231 | 50 mg | brown | capsule | — |
| 6;MS | 12.5 mg | orange | capsule | — |
Sunitinib recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long sunitinib keeps
No sunitinib label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does sunitinib expire? The in-use limits and storage rules from its labelsRelated calculators
Frequently asked questions
What is sunitinib?
Sutent (Sunitinib Malate) is a kinase inhibitor used to treat Renal Cell Carcinoma, Pancreatic Neoplasms, Neuroendocrine Tumors, Gastrointestinal Stromal Tumors.
What kind of drug is sunitinib?
The FDA classifies sunitinib as a kinase inhibitor. Kinase inhibitors block protein kinases, the enzymes that relay 'grow and divide' signals inside cells. By shutting down the overactive kinase signals that a tumor depends on, they help slow or stop cancer cells from multiplying. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take sunitinib with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run sunitinib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does sunitinib come in?
Across the brands we track, sunitinib is currently marketed as capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic sunitinib?
We do not currently list a generic-labelled sunitinib product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has sunitinib been recalled?
The FDA's Enforcement database lists 2 recall records whose product description mentions sunitinib. The most recent: Sunitinib Malate Capsules (Oct 18, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Sunitinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/sunitinib
- MLA
- “Sunitinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/sunitinib.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for sunitinib on DailyMed (NIH) ↗ — including its boxed warning in full.