Axitinib: uses, dosing, side effects & brands
Axitinib is a kinase inhibitor sold in the U.S. under one brand, for renal cell carcinoma. 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
- Available as
- Tablet
- Sold as
- Inlyta
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How axitinib is dosed
From the FDA label for Inlyta (application NDA202324). Other axitinib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
INLYTA 5 mg orally twice daily with avelumab 800 mg every 2 weeks. ( 2.1 ) • INLYTA 5 mg orally twice daily with pembrolizumab 200 mg every 3 weeks or 400 mg every 6 weeks. ( 2.1 ) • INLYTA as a single agent the starting dose is 5 mg orally twice daily. ( 2.1 ) • Dose adjustments can be made based on individual safety and tolerability. ( 2.2 ) • Administer INLYTA dose approximately 12 hours apart with or without food. ( 2.1 ) • INLYTA should be swallowed whole with a glass of water. ( 2.1 ) • See Full Prescribing Information for dosage modifications for adverse reactions. ( 2.2 ) • If a strong CYP3A4/5 inhibitor is required, decrease the INLYTA dose by approximately half. ( 2.2 ) • For patients with moderate hepatic impairment, decrease the starting dose by approximately half. ( 2.2 ) 2.1 Recommended Dosing First-Line Advanced RCC INLYTA in Combination with Avelumab The recommended starting dosage of INLYTA is 5 mg orally taken twice daily (12 hours apart) with or without food in combination with avelumab 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. When INLYTA is used in combination with avelumab, dose escalation of INLYTA above the initial 5 mg dose may be considered at intervals of two weeks or longer. Review the Full Prescribing Information for recommended avelumab dosing information.…
Axitinib side effects
The following clinically significant adverse reactions are discussed elsewhere in the labeling [see Warnings and Precautions (5) ] : • Hypertension [see Warnings and Precautions (5.1) ] • Arterial thromboembolic events [see Warnings and Precautions (5.2) ] • Venous thromboembolic events [see Warnings and Precautions (5.3) ] • Hemorrhage [see Warnings and Precautions (5.4) ] • Cardiac failure [see Warnings and Precautions (5.5) ] • Gastrointestinal perforation and fistula formation [see Warnings and Precautions (5.6) ] • Thyroid dysfunction [see Warnings and Precautions (5.7) ] • Reversible posterior leukoencephalopathy syndrome [see Warnings and Precautions (5.9) ] • Proteinuria [see Warnings and Precautions (5.10) ] • Hepatotoxicity [see Warnings and Precautions (5.11) ] • Hepatic impairment [see Warnings and Precautions (5.12) ] Most common adverse reactions (≥20%) are: INLYTA in combination with avelumab: diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain, and headache. ( 6.1 ) INLYTA in combination with pembrolizumab: diarrhea, fatigue/asthenia, hypertension, hepatotoxicity, hypothyroidism, decreased appetite, palmar-plantar erythrodysesthesia, nausea, stomatitis/mucosal inflammation, dysphonia, rash, cough, and…
Who shouldn’t take axitinib
None. None. ( 4 )
Axitinib drug interactions
Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce the INLYTA dose. ( 2.2 , 7.1 ) • Avoid strong CYP3A4/5 inducers. ( 7.2 ) 7.1 CYP3A4/5 Inhibitors Co-administration of ketoconazole, a strong inhibitor of CYP3A4/5, increased the plasma exposure of axitinib in healthy volunteers. Co-administration of INLYTA with strong CYP3A4/5 inhibitors should be avoided. Grapefruit or grapefruit juice may also increase axitinib plasma concentrations and should be avoided. Selection of concomitant medication with no or minimal CYP3A4/5 inhibition potential is recommended. If a strong CYP3A4/5 inhibitor must be co-administered, the INLYTA dose should be reduced [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) ] . 7.2 CYP3A4/5 Inducers Co-administration of rifampin, a strong inducer of CYP3A4/5, reduced the plasma exposure of axitinib in healthy volunteers. Co-administration of INLYTA with strong CYP3A4/5 inducers (e.g., rifampin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, and St. John's wort) should be avoided. Selection of concomitant medication with no or minimal CYP3A4/5 induction potential is recommended [see Dosage and Administration (2.2) , Clinical Pharmacology (12.3) ] . Moderate CYP3A4/5 inducers (e.g., bosentan, efavirenz, etravirine, modafinil, and nafcillin) may also reduce the plasma exposure of axitinib and should be avoided if possible.
Every axitinib 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: Inlyta.
What axitinib 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;5;XNB | 5 mg | red | triangle | — |
| Pfizer;1;XNB | 1 mg | red | oval | — |
| Pfizer;1;XNB | 1 mg | red | oval | — |
| Pfizer;5;XNB | 5 mg | red | triangle | — |
Can you crush or split axitinib?
At least one axitinibproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each axitinib label says about crushing, splitting and chewingAxitinib and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for axitinib: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the use of axitinib during breastfeeding. Because axitinib is more than 99% bound to plasma proteins, the amount in milk is likely to be low. The manufacturer recommends that breastfeeding be discontinued during axitinib therapy and for 2 weeks after the final dose of therapy. When axitinib is used in combination with avelumab or pembrolizumab, refer to those LactMed records.
National Institute of Child Health and Human Development, record revised August 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about axitinib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 3,105 reports naming axitinib, and the FDA flagged 93% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- diarrhoea290 reports
- hypertension198 reports
- fatigue193 reports
- malignant neoplasm progression185 reports
- neoplasm progression118 reports
- decreased appetite115 reports
- hypothyroidism113 reports
- acute kidney injury102 reports
Read these as a signal, not a rate. A report does not mean axitinib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is axitinib?
Inlyta (Axitinib) is a kinase inhibitor used to treat Renal Cell Carcinoma.
What kind of drug is axitinib?
The FDA classifies axitinib 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 axitinib 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 axitinib 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 axitinib come in?
Across the brands we track, axitinib is currently marketed as tablet, 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 axitinib?
We do not currently list a generic-labelled axitinib 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.
Cite this page
- APA
- pharmaranks. (2026, July 24). Axitinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/axitinib
- MLA
- “Axitinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/axitinib.
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 axitinib on DailyMed (NIH) ↗.