Prescription medicine

Axitinib Brand names: Inlyta

Axitinib (Inlyta) is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the axitinib FDA label on DailyMed (effective March 12, 2026, U.S. Pharmaceuticals); the NDA 202324 record on Drugs@FDA; every axitinib label on DailyMed.

Highlights of the record

FDA label of March 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
INLYTA is a kinase inhibitor indicated:
in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Forms and strengths

1 mg
5 mg

Film-coated tablet.

On the market

Earliest approval on file: January 27, 2012 Inlyta, Pf Prism Cv; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 1 first October 30, 2025; 1 with a marketed status in Drugs@FDA
Labelers listed (NDC): 2 of which 0 under generic applications, 2 under brand applications, repackagers included
Last listed patent: July 12, 2037 Inlyta tablets; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 19,366 through July 30, 2026

What is axitinib used for?

From the label: indications and usage
INLYTA is a kinase inhibitor indicated:
in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 )
in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. ( 1.1 )
as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. ( 1.2 ) 1.1 First-Line Advanced Renal Cell Carcinoma INLYTA in combination with avelumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). […]

FDA pharmacologic class: Kinase Inhibitor.

Source: FDA drug label (INLYTA), NDA202324 (Pf Prism Cv), as published by U.S. Pharmaceuticals, effective March 12, 2026 (SPL set 8a903e31-936e-4ed7-8a59-59f32374f338), via openFDA; the full label on DailyMed

What does the patient leaflet for axitinib say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What should I avoid while taking INLYTA?
Do not drink grapefruit juice or eat grapefruit. Grapefruit may increase the amount of INLYTA in your blood.

From the patient leaflet: How should I store INLYTA?
Store INLYTA at room temperature between 68°F to 77°F (20°C to 25°C). Keep INLYTA and all medicines out of the reach of children.

Is there a generic for axitinib (Inlyta)?

The FDA approved the first generic axitinib on October 30, 2025. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.

The Orange Book lists 4 patents for Inlyta tablets: the compound patent runs to December 14, 2030 (pediatric exclusivity to June 14, 2031), and the last listed entry to July 12, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2012 earliest approval on file
2025 first generic approved
2037 last listed patent

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

What does the axitinib label say about other medicines?

The axitinib label names 17 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name axitinib. 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
Avelumab	warnings and precautions	When used in combination with avelumab or pembrolizumab, higher frequencies of Grade 3 and 4 ALT and AST elevation may occur.
Bosentan	drug interactions	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.
Carbamazepine	drug interactions	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.
Dexamethasone	drug interactions	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.
Efavirenz	drug interactions	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.
Etravirine	drug interactions	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.
Ketoconazole	drug interactions	CYP3A4/5 Inhibitors Co-administration of ketoconazole, a strong inhibitor of CYP3A4/5, increased the plasma exposure of axitinib in healthy volunteers.
Modafinil	drug interactions	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.
Nafcillin	drug interactions	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.
Pembrolizumab	warnings and precautions	When used in combination with avelumab or pembrolizumab, higher frequencies of Grade 3 and 4 ALT and AST elevation may occur.
Phenobarbital	drug interactions	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.
Phenytoin	drug interactions	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.
Rifabutin	drug interactions	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.
Rifampin	drug interactions	CYP3A4/5 Inducers Co-administration of rifampin, a strong inducer of CYP3A4/5, reduced the plasma exposure of axitinib in healthy volunteers.

Every other medicine the axitinib label names

Medicine named	Section	What the label says
Rifapentine	drug interactions	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.
Sorafenib	warnings and precautions	… patients (32%) receiving INLYTA and 25/232 patients (11%) receiving sorafenib [see Adverse Reactions (6.1) ].
Sunitinib	warnings and precautions	MACE occurred in 7% of patients with advanced RCC treated with INLYTA in combination with avelumab compared to 3.4% treated with sunitinib in a randomized trial, JAVELIN Renal 101.

Other labels that name axitinib

Voriconazole

Check axitinib against other medicines

What do FAERS reports show for axitinib?

The FDA Adverse Event Reporting System holds 19,366 reports that list axitinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,908 are coded as a death and 4,996 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)2,666
Diarrhoea (named in the label)2,578
Fatigue (named in the label)2,115
Hypertension (named in the label)1,326
Neoplasm Progression1,323
Disease Progression (a use or a product term, not a reaction)1,212
Off Label Use (a use or a product term, not a reaction)1,206
Nausea (named in the label)1,143

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