Crizotinib
Crizotinib is a targeted cancer medicine (a kinase inhibitor) used for certain ALK- or ROS1-positive lung cancers, ALK-positive anaplastic large cell lymphoma, and ALK-positive inflammatory myofibroblastic tumor.
🧬 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 1 clinical label set 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 →
Crizotinib (Xalkori) is a targeted cancer medicine, on the market since about 2011, that blocks the abnormal ALK or ROS1 proteins driving certain advanced non-small cell lung cancers, plus two rare ALK-positive cancers (a lymphoma and a soft-tissue tumor). It was the first ALK-targeted drug, and newer ones are often preferred first for ALK-positive lung cancer. Most people manage it fairly well, though vision changes (blurring, light flashes), nausea, diarrhea and swelling are common. The serious risks hit the liver, lungs, heart rhythm and eyes, so report yellowing skin, dark urine, new cough or breathlessness, fainting, or vision loss right away.
Clinical pearls
- Swallow the capsules whole without chewing, crushing or splitting, and avoid grapefruit and grapefruit juice, which can raise crizotinib levels.
- If you miss a dose, take it unless the next one is due within 6 hours, and never repeat a dose after vomiting.
- Tell every prescriber you take it, since beta-blockers, digoxin and other heart-slowing or rhythm-altering drugs can dangerously disturb your heartbeat.
- Women should use effective contraception for 45 days after the last dose, and men should use condoms for 90 days afterward.
Patient information guide A plain-language walkthrough of Crizotinib, written from its FDA label.
What Crizotinib is used for
▾
Crizotinib is a targeted cancer medicine used for several ALK- or ROS1-driven cancers.
- Xalkori: adults with metastatic NSCLC whose tumors are ALK- or ROS1-positive, as found by an FDA-approved test.
- Xalkori: children 1 year and older and young adults with relapsed or refractory, systemic ALK-positive ALCL. Safety and effectiveness have not been established in older adults with this condition.
- Xalkori: adults and children 1 year and older with ALK-positive IMT that cannot be removed by surgery, has recurred, or has not responded to treatment.
How Crizotinib works
▾
Crizotinib blocks several proteins called receptor tyrosine kinases, including ALK, ROS1, c-Met and RON. In some cancers, a gene change creates abnormal ALK fusion proteins that push cells to multiply and survive.
By blocking these signals, crizotinib can slow the growth of tumors that depend on them.
Crizotinib dosage
▾
Xalkori capsules are swallowed whole by mouth, twice daily, with or without food. Do not chew, crush or split them. Treatment typically continues until the disease progresses or side effects become unacceptable.
- Missed dose: make it up unless your next dose is due within 6 hours.
- Vomiting after a dose: do not take an extra dose. Take the next one at the usual time.
- Dosing for children and young adults is based on body surface area. Your prescriber will set your dose and may adjust it if side effects occur.
Dosing details from the FDA-approved label
From the Crizotinib 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.
- ALK- or ROS1-Positive Metastatic NSCLC (Adults)
- 250 mg orally twice daily, with or without food, until disease progression or unacceptable toxicity occurs
- For adults who cannot swallow capsules, pellets 250 mg (2 x 50 mg + 1 x 150 mg) orally twice daily
- Relapsed or Refractory, Systemic ALK-Positive ALCL (Pediatric Patients 1 year of age and older and Young Adults)
- 280 mg/m2 orally twice daily, based on body surface area (Table 2), with or without food, until disease progression or unacceptable toxicity occurs
- BSA 1.7 m2 or greater: 500 mg twice daily; no more than 4 oral pellet shells for a single dose
- Unresectable, Recurrent, or Refractory ALK-Positive IMT (Adults)
- 250 mg orally twice daily, with or without food, until disease progression or unacceptable toxicity occurs
- Unresectable, Recurrent, or Refractory ALK-Positive IMT (Pediatric Patients 1 year of age and older)
- 280 mg/m2 orally twice daily, based on body surface area (Table 3), with or without food, until disease progression or unacceptable toxicity occurs
- BSA 1.7 m2 or greater: 500 mg twice daily; no more than 4 oral pellet shells for a single dose
- Dose reduction for adverse reactions, adult patients with NSCLC or IMT
- First reduction 200 mg twice daily
- Second reduction 250 mg once daily
- Permanently discontinue if unable to tolerate 250 mg once daily
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • Metastatic NSCLC: The recommended dosage is 250 mg orally twice daily. ( 2.3 ) • Systemic ALCL: The recommended dosage is 280 mg/m 2 orally twice daily based on body surface area. ( 2.3 ) • Unresectable IMT: o Adult: The recommended dosage is 250 mg orally twice daily. ( 2.3 ) o Pediatric: The recommended dosage is 280 mg/m 2 orally twice daily based on body surface area. ( 2.3 ) • See full prescribing information for dosage adjustments by indication for patients with moderate or severe hepatic impairment or severe renal impairment. ( 2.7 , 2.8 ) 2.1 Patient Selection Select patients for the treatment of metastatic NSCLC with XALKORI based on the presence of ALK or ROS1 positivity in tumor specimens [see Clinical Studies (14.1 , 14.2 , 14.3) ] . Information on FDA-approved tests for the detection of ALK and ROS1 rearrangements in NSCLC is available at http://www.fda.gov/companiondiagnostics . 2.2 Recommended Testing During Treatment with XALKORI • Monitor liver function tests, including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin, every 2 weeks during the first 2 months of treatment, then once a month, and as clinically indicated, with more frequent repeat testing for increased liver transaminases, alkaline phosphatase, or total bilirubin in patients who develop increased transaminases [see Warnings and Precautions (5.1) ] . • Monitor complete blood counts including differential weekly for the first month of therapy and then at least monthly, with more frequent monitoring if Grade 3 or 4 abnormalities, fever, or infection occur [see Adverse Reactions (6.1) ] . • For pediatric and young adult patients with ALCL or pediatric patients with IMT, obtain baseline and follow-up ophthalmologic examinations including retinal examination within 1 month of starting XALKORI and every 3 months thereafter [see Warnings and Precautions (5.5) ] . 2.3 Recommended Dosage The recommended dosage of XALKORI is provided in Table 1. Table 1.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Crizotinib side effects
▾
Common side effects in people taking crizotinib include:
Common side effects
- Vision changes (such as blurred vision or seeing flashes)
- Nausea, vomiting and diarrhea
- Constipation
- Swelling (edema)
- Tiredness
- Decreased appetite
- Dizziness
- Numbness or tingling (neuropathy)
- Raised liver tests
When to get medical help
- Call your doctor right away for yellowing of the skin or eyes, dark urine, or severe stomach pain, which can signal liver damage.
- Get help for new or worsening cough, shortness of breath or breathing trouble, which can signal lung inflammation (ILD/pneumonitis).
- Get help for fainting, a very slow heartbeat, dizziness or an irregular heartbeat.
- Tell your doctor right away about any new vision changes or vision loss.
- Children and young adults with ALCL or IMT should tell their care team about severe or persistent nausea, vomiting, diarrhea or mouth sores.
- Tell your doctor right away if you become pregnant during treatment.
Crizotinib warnings and precautions
▾
- Liver damage: fatal cases have occurred. Liver tests are done every 2 weeks for the first 2 months, then monthly.
- Lung inflammation (ILD/pneumonitis): can be severe or fatal. Treatment is stopped permanently if it is diagnosed.
- QT prolongation: avoid in congenital long QT syndrome. ECGs and electrolytes are monitored in people at risk.
- Slow heartbeat: heart rate and blood pressure should be checked regularly.
- Severe vision loss: report new vision symptoms. Children and young adults with ALCL or IMT need regular eye exams.
- Stomach and bowel problems: severe in children and young adults with ALCL or IMT.
- Pregnancy: can cause fetal harm.
Crizotinib interactions
▾
Crizotinib is processed by the CYP3A enzyme, so many drugs can affect it.
- Strong CYP3A inhibitors: raise crizotinib levels and side effect risk.
- Strong CYP3A inducers: lower crizotinib levels and may reduce effectiveness.
- Grapefruit and grapefruit juice: may raise crizotinib levels.
- CYP3A substrate drugs: crizotinib can raise their levels.
- QT-prolonging drugs: added risk of heart rhythm changes.
- Drugs that slow the heart (beta-blockers, non-dihydropyridine calcium channel blockers, clonidine, digoxin): added risk of slow heartbeat.
Interactions listed in the FDA-approved label
From the Crizotinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A inhibitors: Increase crizotinib plasma concentrations, which may increase the risk of adverse reactions of XALKORI. Avoid concomitant use. If unavoidable, reduce the XALKORI dosage.
- Grapefruit or grapefruit juice: May also increase plasma concentrations of crizotinib. Avoid grapefruit or grapefruit juice.
- Moderate CYP3A inhibitors: May increase crizotinib exposure (listed with strong or moderate CYP3A inhibitors). Use caution with concomitant use.
- Strong CYP3A inducers: Decrease crizotinib plasma concentrations, which may decrease the efficacy of XALKORI. Avoid concomitant use.
- CYP3A substrates: Crizotinib increases plasma concentrations of CYP3A substrates, which may increase the risk of adverse reactions of these substrates. Avoid concomitant use where minimal concentration changes may lead to serious adverse reactions. If unavoidable, decrease the CYP3A substrate dosage in accordance with approved product labeling.
- Drugs that prolong the QT interval: XALKORI can prolong the QT/QTc interval. Avoid concomitant use.
- Drugs that cause bradycardia (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, clonidine, digoxin): XALKORI can cause bradycardia. Avoid concomitant use.
Read the label’s full interactions text
7 DRUG INTERACTIONS • Strong CYP3A Inhibitors: Avoid concomitant use. ( 2.9 , 7.1 ) • Strong CYP3A Inducers: Avoid concomitant use. ( 7.1 ) • CYP3A Substrates: Avoid concomitant use with CYP3A substrates, where minimal concentration changes may lead to serious adverse reactions. ( 7.2 ) 7.1 Effect of Other Drugs on XALKORI Strong or Moderate CYP3A Inhibitors Concomitant use of crizotinib with strong CYP3A inhibitors increases crizotinib plasma concentrations [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions of XALKORI. Avoid concomitant use of strong CYP3A inhibitors. If concomitant use of strong CYP3A inhibitors is unavoidable, reduce the XALKORI dosage [see Dosage and Administration (2.9) ] . Avoid grapefruit or grapefruit juice which may also increase plasma concentrations of crizotinib. Use caution with concomitant use of moderate CYP3A inhibitors. Strong CYP3A Inducers Concomitant use of crizotinib with strong CYP3A inducers decreases crizotinib plasma concentrations [see Clinical Pharmacology (12.3) ] , which may decrease the efficacy of XALKORI. Avoid concomitant use of strong CYP3A inducers. 7.2 Effect of XALKORI on Other Drugs CYP3A Substrates Concomitant use of crizotinib increases plasma concentrations of CYP3A substrates [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions of these substrates. Avoid concomitant use of XALKORI with CYP3A substrates where minimal concentration changes may lead to serious adverse reactions. If concomitant use of XALKORI is unavoidable, decrease the CYP3A substrate dosage in accordance with approved product labeling. 7.3 Drugs That Prolong the QT Interval XALKORI can prolong the QT/QTc interval. Avoid concomitant use of XALKORI with drugs that prolong the QT interval [see Warnings and Precautions (5.3) , Clinical Pharmacology (12.2) ] . 7.4 Drugs That Cause Bradycardia XALKORI can cause bradycardia.
Excerpted — the section continues on the label. 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.
Before taking Crizotinib
▾
- No contraindications are listed for Xalkori.
- Tell your doctor about liver or kidney problems, since doses may be lowered.
- Tell your doctor about heart rhythm problems, slow heartbeat, heart failure or electrolyte problems.
- Avoid pregnancy and use effective contraception during treatment and for 45 days after. Men should use condoms during treatment and for 90 days after.
- Do not breastfeed during treatment and for 45 days after the last dose.
- Fertility may be reduced.
- Not established in children under 1 year or in any child with NSCLC.
- In older adults with NSCLC, no overall differences in safety or effectiveness were seen.
What Crizotinib does in the body
▾
In an ECG study of 52 people with ALK-positive NSCLC, crizotinib raised the QTc interval (a measure of heart rhythm timing) by a maximum average of about 12 ms. Higher drug levels in the blood were linked to a greater increase.
How your body processes Crizotinib
▾
After a capsule is swallowed, blood levels peak in about 4 to 6 hours. Steady levels build up within about 15 days of twice-daily use. A high-fat meal lowers absorption only slightly. Crizotinib is mainly broken down by the CYP3A enzyme, with a half-life of about 42 hours. Most of it leaves in the stool, with some in the urine.
How to store Crizotinib
▾
Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) . Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 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 →
Supplements & herbs that interact with Crizotinib
157 supplements and herbal products have documented interactions with Crizotinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 8
- Moderate · 112
- Minor · 37
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.
Crizotinib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Crizotinib — the kind of thing our pharmacy team would talk through with you at the counter.
What is crizotinib used for?
▾
How should I take my capsules?
▾
What side effects are common?
▾
When should I call my doctor right away?
▾
Can I take other medicines or have grapefruit with it?
▾
What about pregnancy and breastfeeding?
▾
Is Crizotinib available over the counter?
▾
When was Crizotinib first available?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Crizotinib on HelloPharmacist
Crizotinib forms and strengths (how it comes)
Crizotinib 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
How this form is used
- Xalkori capsules are used for adults with ALK- or ROS1-positive metastatic NSCLC.
- Xalkori capsules are used for ALK-positive relapsed or refractory ALCL in children 1 year and older and young adults.
- Xalkori capsules are used for ALK-positive IMT in adults and children 1 year and older.
- Swallow Xalkori capsules whole, twice daily, with or without food.
- Do not chew, crush or split Xalkori capsules.
- If you vomit after a dose of Xalkori, do not take an extra dose.
Crizotinib on the U.S. market: products, makers and brands
How Crizotinib 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.
1 company lists 5 Crizotinib product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2011. Brand names on the directory include Xalkori; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Crizotinib is used (Medicaid data)
A general measure of how commonly Crizotinib 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 Crizotinib 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.
How commonly is Crizotinib prescribed? Of the 1,601 medications we measure, Crizotinib ranks #1,480 by Medicaid prescriptions — more than 8% of them.
Utilization by Crizotinib 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.
crizotinib 250 MG Oral Capsule
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1148504
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 Crizotinib, 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 1 of 2 listed Crizotinib NDCs with Medicaid activity.
Compare Crizotinib products
A representative set of FDA-listed product records for Crizotinib — 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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 20 mg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
| 50 mg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
| 150 mg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
| 200 mg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
| 250 mg | Oral | Pfizer Laboratories Div Pfizer Inc | NDA | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Crizotinib NDCs →
Crizotinib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Crizotinib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Crizotinib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Crizotinib FDA approval history
How Crizotinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Crizotinib 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 no Crizotinib recalls since July 2021.
✅No Crizotinib recalls on record since July 2021Source: 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.
RxCUI 1148495 2 dose forms · 5 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 1148497In current FDA listings -
Dose form (SCDF) Oral Pellet RxCUI 2670165No current FDA listing
Look up RxCUI 1148495 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.
Crizotinib supply and shortage status
Whether Crizotinib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Crizotinib brand names
Crizotinib is sold under one brand name in the FDA directory — Xalkori. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Crizotinib: manufacturers and labelers
One company lists Crizotinib products with the FDA. By number of product records, the largest are Pfizer Laboratories Div Pfizer Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Crizotinib drug class (RxNorm)
Crizotinib belongs to the Kinase Inhibitor class.
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 Crizotinib 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.
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 →