Prescription medicine
Crizotinib Brand names: Xalkori
Crizotinib (Xalkori) is a prescription medicine with an FDA approval on record since 2011. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the crizotinib FDA label on DailyMed (effective July 22, 2025, Pfizer Laboratories Div Pfizer Inc); the NDA 202570 record on Drugs@FDA; every crizotinib label on DailyMed.
Highlights of the record
FDA label of July 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageXALKORI is a kinase inhibitor indicated for the treatment of
adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test.
Forms and strengths
- 20 mg
- 50 mg
- 150 mg
- 200 mg
- 250 mg
Capsule (coated pellets); capsule.
On the market
- Earliest approval on file
- August 26, 2011 Xalkori, Pf Prism Cv; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 6, 2029 Xalkori capsules; 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
- 12,638 through July 30, 2026
What is crizotinib used for?
From the label: indications and usageXALKORI is a kinase inhibitor indicated for the treatment of
adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. ( 1.1 , 2.1 )
pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. ( 1.2 , 2.3 ) o Limitations of Use: The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL. […]
Conditions named in the indications of crizotinib's FDA labels, with every medicine labeled for each:
From other crizotinib labelsLung cancer: ALK- or ROS1-Positive Metastatic Non-Small Cell Lung Cancer XALKORI is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as …
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Xalkori), NDA217581 (Pf Prism Cv), as published by Pfizer Laboratories Div Pfizer Inc, effective July 22, 2025 (SPL set 2a51b0de-47d6-455e-a94c-d2c737b04ff7), via openFDA; the full label on DailyMed
What does the patient leaflet for crizotinib 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 XALKORI?XALKORI may cause serious side effects, including: • Liver problems. XALKORI may cause life-threatening liver injury that may lead to death. Your healthcare provider should do blood tests to check your liver every 2 weeks during the first 2 months of treatment with XALKORI, then 1 time a month and as recommended by your healthcare provider during treatment. Tell your healthcare provider right away if you develop any of the following new or worsening symptoms: o yellowing of your skin or the white part of your eyes o severe tiredness o dark or brown (tea color) urine o nausea or vomiting o decreased appetite o pain on the right side of your stomach o bleed or bruise more easily than normal o itching • Lung problems (pneumonitis). XALKORI may cause life-threatening lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening symptoms, including: o trouble breathing or shortness of breath o cough with or without mucous o fever • Heart problems. XALKORI may cause very slow, very fast, or abnormal heartbeats. Your healthcare provider may check your pulse rate and blood pressure regularly during treatment with XALKORI. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. Tell your healthcare provider if you take any heart or blood pressure medicines. • Severe vision problems. Vision problems are common with XALKORI. These problems usually happen within 1 week of starting treatment with XALKORI. Vision problems with XALKORI can be severe and may cause partial or complete loss of vision in one or both eyes. […]
From the patient leaflet: What should I avoid while taking XALKORI?Do not drink grapefruit juice, eat grapefruit or take supplements containing grapefruit extract during treatment with XALKORI. These may increase the amount of XALKORI in the blood. • XALKORI can cause changes in vision, dizziness, and tiredness. Do not drive or operate machinery if you have any of these symptoms. • Avoid spending prolonged time in sunlight. XALKORI can make your skin sensitive to the sun (photosensitivity), and you may burn more easily. You should use sunscreen and wear protective clothing that covers your skin to help protect against sunburn if you have to be in the sunlight during treatment with XALKORI.
From the patient leaflet: How should I store XALKORI?Store XALKORI capsules at room temperature between 68°F to 77°F (20°C to 25°C). • Store XALKORI oral pellets at room temperature between 68°F to 77°F (20°C to 25°C). Keep XALKORI and all medicines out of the reach of children.
Source: FDA drug label (Xalkori), NDA217581 (Pf Prism Cv), as published by Pfizer Laboratories Div Pfizer Inc, effective July 22, 2025 (SPL set 2a51b0de-47d6-455e-a94c-d2c737b04ff7), via openFDA; the full label on DailyMed
Is there a generic for crizotinib (Xalkori)?
No generic crizotinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Xalkori capsules: the compound patent runs to November 6, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2011 earliest approval on file
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the crizotinib label say about other medicines?
The crizotinib label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name crizotinib. 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 |
|---|---|---|
| Clonidine | drug interactions | Avoid concomitant use of XALKORI with drugs that cause bradycardia (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, clonidine, and digoxin) [see Warnings and Precautions (5.4) ]. |
| Digoxin | drug interactions | Avoid concomitant use of XALKORI with drugs that cause bradycardia (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, clonidine, and digoxin) [see Warnings and Precautions (5.4) ]. |
Source: FDA drug label (Xalkori), NDA217581 (Pf Prism Cv), as published by Pfizer Laboratories Div Pfizer Inc, effective July 22, 2025 (SPL set 2a51b0de-47d6-455e-a94c-d2c737b04ff7), via openFDA; the full label on DailyMed
What do FAERS reports show for crizotinib?
The FDA Adverse Event Reporting System holds 12,638 reports that list crizotinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,792 are coded as a death and 3,067 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as crizotinib?
26 other medicines are given the same way (oral) and in the same FDA class as crizotinib or labeled mainly for the same use (lung cancer), the same class first. Lung cancer lists all 55 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Erlotinib | Lung cancer | 10 labelers | n/a | No current entry |
| Afatinib | Lung cancer | 1 labeler | n/a | No current entry |
| Selpercatinib | Lung cancer | none listed | n/a | No current entry |
| Gefitinib | Lung cancer | 4 labelers | n/a | No current entry |
| Brigatinib | Lung cancer | none listed | n/a | No current entry |
| Dabrafenib | Lung cancer | none listed | n/a | No current entry |
| Lorlatinib | Lung cancer | none listed | n/a | A presentation being discontinued |
| Trametinib | Lung cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as crizotinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to crizotinib
- 26 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Crizotinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other