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Enzalutamide

Enzalutamide is an androgen receptor inhibitor used to treat several forms of prostate cancer, including castration-resistant prostate cancer and castration-sensitive prostate cancer.

Brand name Xtandi
Drug class Androgen Receptor Inhibitor
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 →

✓No current FDA shortage listed · checked Oct 7, 2026
Enzalutamide at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Enzalutamide (Xtandi) is a prostate cancer medicine that blocks the receptors cancer cells use to receive testosterone signals, slowing their growth; on the U.S. market since about 2012, it is a standard hormone treatment across several stages of the disease, usually alongside hormone-lowering therapy. Most men handle it reasonably well, with tiredness and hot flushes the side effects people notice most. The key risk is a seizure, which means stopping it for good, so flag any seizure history, brain injury or stroke before starting. It also makes falls and fractures more likely, nudges up heart risk, and lowers the levels of many other medicines.

Clinical pearls

  • Swallow the tablets or capsules whole with water, and never chew, crush, cut, open or dissolve them.
  • Enzalutamide speeds the breakdown of many drugs, including warfarin, so other prescriptions may need checking or dose changes when it starts.
  • If you take digoxin, tell the lab, because enzalutamide can make digoxin blood tests read falsely high.
  • Men with a partner who could become pregnant need effective contraception during treatment and for three months after the last dose.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet, Capsule
Earliest FDA record2012
Companies listing it with the FDA1
FDA label last updatedJul 28, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Enzalutamide, written from its FDA label.

What Enzalutamide is used for

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Enzalutamide is an androgen receptor inhibitor approved for treating prostate cancer at several different stages. Xtandi is the brand name for all currently approved forms.

  • Castration-resistant prostate cancer (CRPC): Cancer that continues to grow even when testosterone is at very low levels — Xtandi is approved for this whether or not the cancer has spread.
  • Metastatic castration-sensitive prostate cancer (mCSPC): Cancer that has spread to other parts of the body and still responds to testosterone-lowering therapy — Xtandi is used alongside a GnRH analog or after surgical testosterone removal.
  • Non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrence (nmCSPC with high-risk BCR): Cancer that has not spread but shows rising PSA levels after initial treatment, putting it at high risk of spreading — Xtandi may be used with or without a GnRH analog in this setting.

How Enzalutamide works

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Prostate cancer cells depend on androgens (male hormones like testosterone) to grow. They do this through androgen receptors — proteins inside cancer cells that act like an on-switch when testosterone binds to them. Enzalutamide blocks this switch at multiple points: it competes with testosterone to bind the receptor, prevents the activated receptor from entering the cell nucleus, and stops it from interacting with DNA. Without that signal, cancer cells stop multiplying and can begin to die.

Enzalutamide also produces an active metabolite called N-desmethyl enzalutamide, which works in a similar way and contributes to the overall effect.

Enzalutamide dosage

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Enzalutamide is taken by mouth once daily, with or without food — a high-fat meal does not meaningfully affect how the drug is absorbed. Both the capsule and tablet forms of Xtandi must be swallowed whole with plenty of water.

  • Xtandi capsules: Do not chew, open, or dissolve — swallow whole.
  • Xtandi tablets: Do not cut, crush, or chew — swallow whole. Smaller tablet sizes are available for people who have difficulty swallowing.
  • If you experience a significant side effect, your doctor may temporarily pause or reduce your dose rather than stop treatment completely.
  • Follow your prescriber's instructions exactly — your dose may need to be adjusted based on other medications you take.

Dosing details from the FDA-approved label

From the Enzalutamide 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.

  • Castration-resistant prostate cancer (CRPC) or metastatic castration-sensitive prostate cancer (mCSPC)
    • 160 mg administered orally once daily with or without food until disease progression or unacceptable toxicity
    • Take each capsule or tablet whole with a sufficient amount of water
    • Should also receive a GnRH analog concurrently or have had bilateral orchiectomy
  • Non-metastatic castration-sensitive prostate cancer (nmCSPC) with high-risk biochemical recurrence (BCR)
    • 160 mg administered orally once daily with or without food until disease progression or unacceptable toxicity
    • May be treated with or without a GnRH analog
    • Treatment can be suspended if PSA is undetectable (< 0.2 ng/mL) after 36 weeks of therapy; reinitiate when PSA has increased to ≥ 2.0 ng/mL after prior radical prostatectomy or ≥ 5.0 ng/mL after prior primary radiation therapy
  • ≥ Grade 3 or intolerable adverse reaction
    • Withhold XTANDI for one week or until symptoms improve to ≤ Grade 2, then resume at the same or a reduced dose (120 mg or 80 mg) if warranted
  • Coadministration with a strong CYP2C8 inhibitor that cannot be avoided
    • Reduce the XTANDI dosage to 80 mg once daily
    • If the strong inhibitor is discontinued, increase to the dosage used prior to its initiation
  • Coadministration with a strong CYP3A4 inducer that cannot be avoided
    • Increase the XTANDI dosage from 160 mg to 240 mg orally once daily
    • If the strong inducer is discontinued, decrease to the dosage used prior to its initiation
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • Take XTANDI 160 mg administered orally once daily with or without food. ( 2.1 ) • Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. ( 2.1 , 5.7 ) • Patients receiving XTANDI for castration-resistant prostate cancer, or metastatic castration-sensitive prostate cancer should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ( 2.1 ) • Patients with non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis may be treated with or without a GnRH analog. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of XTANDI is 160 mg administered orally once daily with or without food [see Clinical Pharmacology ( 12.3 )] until disease progression or unacceptable toxicity. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Do NOT chew, dissolve, or open the capsules. Do NOT cut, crush, or chew the tablets. Patients with CRPC or mCSPC receiving XTANDI should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Patients with nmCSPC with high-risk BCR may be treated with XTANDI with or without a GnRH analog. For patients who receive XTANDI with or without a GnRH analog, treatment can be suspended if PSA is undetectable (< 0.2 ng/mL) after 36 weeks of therapy. Reinitiate treatment when PSA has increased to ≥ 2.0 ng/mL for patients who had prior radical prostatectomy or ≥ 5.0 ng/mL for patients who had prior primary radiation therapy [see Clinical Studies ( 14 )] . 2.2 Dosage Modifications for Adverse Reactions If a patient experiences a ≥ Grade 3 or an intolerable adverse reaction, withhold XTANDI for one week or until symptoms improve to ≤ Grade 2, then resume at the same or a reduced dose (120 mg or 80 mg) if warranted [see Warnings and Precautions ( 5.1 , 5.2 )] . 2.3 Dosage Modifications for Drug Interactions Strong CYP2C8 Inhibitors Avoid the coadministration of strong CYP2C8 inhibitors. If the coadministration of a strong CYP2C8 inhibitor cannot be avoided, reduce the XTANDI dosage to 80 mg once daily.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Enzalutamide side effects

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The most common side effects of enzalutamide — reported by at least 10% of patients more often than with placebo — include:

Common side effects

  • Fatigue or weakness
  • Hot flushes
  • Musculoskeletal pain (muscles, joints, or back)
  • High blood pressure
  • Constipation or diarrhea
  • Decreased appetite
  • Headache
  • Falls and fractures
  • Decreased appetite and weight loss
  • Headache and dizziness
  • Bleeding (hemorrhage) of various types

When to get medical help

  • Call your doctor immediately if you have a seizure — enzalutamide must be permanently stopped if this happens
  • Seek emergency care for sudden confusion, vision changes, severe headache, or loss of consciousness, which may signal a rare but serious brain condition called PRES
  • Get medical help right away for signs of a serious allergic reaction: swelling of the face, lips, or tongue
  • Tell your doctor about any chest pain, shortness of breath, or signs of a heart problem — ischemic heart disease (reduced blood flow to the heart) has been reported
  • Report any unusual swelling of the face or throat immediately
  • If you have trouble swallowing the capsule or tablet, tell your doctor — choking or severe swallowing difficulty can be life-threatening

More serious reactions — including seizures, signs of PRES (confusion, vision changes, severe headache), allergic reactions with facial or throat swelling, or chest pain suggesting heart problems — require immediate medical attention and may mean stopping the drug permanently.

Enzalutamide warnings and precautions

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  • Seizures: Enzalutamide increases seizure risk, especially in people with prior seizures, brain injury, stroke, or who take other seizure-threshold-lowering drugs. If a seizure occurs, the drug must be stopped for good. Avoid activities where a sudden loss of consciousness could be dangerous.
  • PRES (Posterior Reversible Encephalopathy Syndrome): A rare but serious neurological condition that can cause rapid-onset confusion, blindness, headache, or seizure. Requires brain imaging to confirm and immediate discontinuation of enzalutamide.
  • Ischemic heart disease: Reduced blood flow to the heart occurred more often in enzalutamide-treated patients. Cardiovascular risk factors like high blood pressure and diabetes should be managed carefully.
  • Falls and fractures: Roughly twice as common with enzalutamide versus placebo. Bone density monitoring and bone-protective treatments should be considered.
  • Embryo-fetal toxicity: Can cause fetal harm and pregnancy loss based on animal studies. Men with partners who could become pregnant must use contraception during treatment and for 3 months after the last dose.
  • Swallowing risk: The capsule and tablet sizes can pose a choking or severe swallowing risk. Swallow with plenty of water; tell your doctor if you have trouble swallowing.

Enzalutamide interactions

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Enzalutamide is broken down by liver enzymes and is itself a strong inducer of those same enzymes, which means it can significantly raise or lower the levels of many medications.

  • Strong CYP2C8 inhibitors (e.g., gemfibrozil): Can significantly raise enzalutamide levels, increasing side effect risk — avoid if possible, or reduce enzalutamide dose.
  • Strong CYP3A4 inducers (e.g., rifampin): Can lower enzalutamide levels and reduce its effectiveness — avoid if possible, or increase enzalutamide dose.
  • Warfarin (blood thinner): Enzalutamide lowers warfarin levels, which could reduce its ability to prevent clots — monitoring and dose adjustment may be needed.
  • Many CYP3A4, CYP2C9, and CYP2C19 substrates: Enzalutamide can substantially lower levels of drugs in these categories (including some sedatives, antifungals, and acid reducers like omeprazole) — some combinations should be avoided entirely.
  • Digoxin (heart medication): Enzalutamide can raise digoxin levels and also interfere with certain digoxin blood tests, producing falsely high results — notify the lab if both drugs are used.

Interactions listed in the FDA-approved label

From the Enzalutamide prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP2C8 inhibitors (e.g., gemfibrozil): Increase plasma concentrations of enzalutamide plus N-desmethyl enzalutamide, which may increase the incidence and severity of adverse reactions of XTANDI. Avoid coadministration; if it cannot be avoided, reduce the dosage of XTANDI.
  • Strong CYP3A4 inducers (e.g., rifampin): Decrease plasma concentrations of enzalutamide plus N-desmethyl enzalutamide, which may decrease the efficacy of XTANDI. Avoid coadministration; if it cannot be avoided, increase the dosage of XTANDI.
  • Certain CYP3A4, CYP2C9, or CYP2C19 substrates: XTANDI decreases concentrations of these substrates, which may reduce their efficacy; where active metabolites are formed, exposure to the active metabolites may increase. Avoid coadministration with substrates for which a minimal decrease in concentration may lead to therapeutic failure; if it cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information.
  • Digoxin immunoassays (laboratory test interference): XTANDI can interfere with certain digoxin immunoassays (e.g., Chemiluminescent Microparticle Immunoassays), resulting in falsely elevated digoxin plasma concentration results. Notify the laboratory conducting the digoxin plasma concentration assay to use an appropriate method in patients receiving XTANDI and digoxin.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Strong CYP2C8 Inhibitors: Avoid strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI. ( 2.3 , 7.1 ) • Strong CYP3A4 Inducers: Avoid strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI. ( 2.3 , 7.1 ) • Avoid coadministration with certain CYP3A4, CYP2C9, or CYP2C19 substrates for which a minimal decrease in concentration may lead to therapeutic failure of the substrate. In cases where active metabolites are formed, there may be increased exposure to the active metabolites. ( 7.2 ) 7.1 Effect of Other Drugs on XTANDI Strong CYP2C8 Inhibitors The coadministration of XTANDI with gemfibrozil (a strong CYP2C8 inhibitor) increases plasma concentrations of enzalutamide plus N-desmethyl enzalutamide, which may increase the incidence and severity of adverse reactions of XTANDI. Avoid the coadministration of XTANDI with strong CYP2C8 inhibitors. If the coadministration of XTANDI with a strong CYP2C8 inhibitor cannot be avoided, reduce the dosage of XTANDI [see Dosage and Administration ( 2.3 ), Clinical Pharmacology ( 12.3 )]. Strong CYP3A4 Inducers The coadministration of XTANDI with rifampin (a strong CYP3A4 inducer and a moderate CYP2C8 inducer) decreases plasma concentrations of enzalutamide plus N-desmethyl enzalutamide, which may decrease the efficacy of XTANDI. Avoid the coadministration of XTANDI with strong CYP3A4 inducers. If the coadministration of XTANDI with a strong CYP3A4 inducer cannot be avoided, increase the dosage of XTANDI [see Dosage and Administration ( 2.3 ), Clinical Pharmacology ( 12.3 )]. 7.2 Effect of XTANDI on Other Drugs Certain CYP3A4, CYP2C9, or CYP2C19 Substrates XTANDI is a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer. The coadministration of XTANDI decreases the concentrations of certain CYP3A4, CYP2C9, or CYP2C19 substrates [see Clinical Pharmacology ( 12.3 )] , which may reduce the efficacy of these substrates.

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.

🌿49 supplements and herbs with documented Enzalutamide interactions, ranked by severity Check Enzalutamide against a supplement or herb →

Before taking Enzalutamide

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  • History of seizures or brain conditions: Including prior seizures, traumatic brain injury, stroke, Alzheimer's disease, or brain lesions — significantly increases seizure risk.
  • Medications that lower the seizure threshold: About half of patients with pre-existing risk factors in one study were also on such medications — review your full drug list with your doctor.
  • Men with female partners of reproductive potential: Must use effective contraception during treatment and for 3 months after stopping, because enzalutamide can cause fetal harm and pregnancy loss.
  • Severe kidney disease (creatinine clearance below 30 mL/min): Not fully studied — use with caution and under close medical supervision.
  • Children: Safety and effectiveness have not been established in pediatric patients.
  • Older adults: No overall difference in safety or effectiveness versus younger patients in clinical trials, though individual sensitivity may vary.
  • Heart disease or cardiovascular risk factors: Ischemic heart disease (reduced blood flow to the heart) has been reported more frequently with enzalutamide — discuss your heart health history with your doctor.

Enzalutamide overdose

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Taking too much enzalutamide significantly raises the risk of seizures. In a dose-escalation study, seizures were reported at doses well above the recommended daily amount. If an overdose is suspected, stop taking the medication and seek medical attention right away. Because enzalutamide stays in the body for many days (it has a long half-life of about 5.8 days), supportive medical care may be needed for an extended period.

What Enzalutamide does in the body

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Enzalutamide works by blocking androgen receptor signaling, which prostate cancer cells rely on to grow. In clinical studies, once-daily dosing reduced PSA (prostate-specific antigen, a marker of prostate cancer activity) to undetectable levels in a large proportion of patients with metastatic castration-sensitive prostate cancer when used alongside androgen deprivation therapy. At the recommended dose, enzalutamide does not cause clinically significant changes in heart rhythm (specifically, it does not meaningfully prolong the QT interval, a measure of electrical activity in the heart).

How your body processes Enzalutamide

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After a single oral dose, enzalutamide is absorbed within about 1 hour (capsule) or 2 hours (tablet), and food does not meaningfully affect absorption. It is extensively bound to plasma proteins and is primarily broken down by the liver through enzymes CYP2C8 and CYP3A4, producing an active metabolite (N-desmethyl enzalutamide) that contributes to its effects. The drug has a long half-life of about 5.8 days, meaning it stays active in the body for an extended time; steady-state levels are reached by around day 28 of daily dosing. Enzalutamide does not require dose adjustment for mild to moderate kidney impairment or any degree of liver impairment, though severe kidney impairment has not been fully studied.

How to store Enzalutamide

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Store XTANDI capsules and tablets at 20°C to 25°C (68°F to 77°F) in a dry place and keep the container tightly closed.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

49

Supplements & herbs that interact with Enzalutamide

49 supplements and herbal products have documented interactions with Enzalutamide in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 36
  • Minor · 12
ACTIVATED CHARCOAL Major ALKANNA Moderate ALPINE RAGWORT Moderate BLACK TEA Moderate BONESET Moderate BORAGE Moderate BUTTERBUR Moderate CANNABIDIOL (CBD) Moderate +41 more
Every supplement checked against Enzalutamide — ranked by severity The full interaction hub: 1 major · 36 moderate · 12 minor · every one linked to its full report. Check Enzalutamide against your exact supplements

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.

Enzalutamide: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Enzalutamide — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is enzalutamide being used to treat in my case?

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Enzalutamide — sold as Xtandi — is approved for treating prostate cancer at different stages. It's used when the cancer is still sensitive to hormone therapy (castration-sensitive) or when it's progressed despite low testosterone levels (castration-resistant). Depending on your specific situation, your doctor may be using it alongside hormone-lowering injections, or possibly on its own. It's worth asking your oncologist which of these settings applies to you so you understand exactly why it's been prescribed.

Does it matter when I take it or whether I take it with food?

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You can take Xtandi with or without food — it doesn't make a meaningful difference in how well the drug is absorbed. What matters most is that you take it at roughly the same time every day, and that you swallow it whole with a full glass of water. Don't crush, chew, or open the capsules, and don't cut, crush, or chew the tablets. If you find it hard to swallow, let your doctor know — there are smaller tablet sizes available.

What side effects should I expect, and which ones should make me call my doctor?

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The most common things people notice are fatigue, hot flushes, muscle or joint pain, high blood pressure, headache, and changes in appetite or bowel habits. These are generally manageable, and your care team can help. But there are some symptoms that need a call or visit right away: a seizure of any kind, sudden confusion or vision changes, severe headache, swelling of your face or throat, or any chest pain or signs of a heart problem. These are rarer but serious, so don't wait if you notice them.

I've heard there's a seizure risk — should I be worried?

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The seizure risk is real but relatively uncommon — about 0.6% of patients in clinical trials experienced one. The risk is higher if you have a history of seizures, brain injury, stroke, or if you take other medications that can lower the seizure threshold. Your doctor will have considered your personal risk before prescribing this. The important thing to know is that if you do have a seizure, you'll need to stop Xtandi permanently. In the meantime, be thoughtful about activities like driving where a sudden blackout could be dangerous — talk to your doctor about what's safe for you.

Are there medications I need to be careful about combining with Xtandi?

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Yes — this is one of the most important things to manage. Xtandi is processed by liver enzymes and it also affects how those same enzymes process other drugs, which means it can raise or lower the blood levels of many common medications. Drugs like gemfibrozil (a cholesterol medicine) can increase Xtandi levels, and antibiotics like rifampin can lower them. Xtandi itself can significantly reduce the effectiveness of certain blood thinners, antifungals, stomach acid medicines, and other drugs. Always give your prescriber and pharmacist a complete list of everything you take — including supplements.

My wife and I are still thinking about having children — does this drug affect that?

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This is an important conversation to have with your doctor before starting Xtandi. Based on animal studies, enzalutamide can cause fetal harm and pregnancy loss if a partner becomes pregnant while you're taking it. You'll need to use effective contraception throughout treatment and for 3 months after your last dose. There's also some evidence from animal studies that it may affect male fertility, though the full picture in humans isn't yet known. If having children is part of your plans, discuss your options — including sperm banking — with your care team before you start.

Is Enzalutamide available over the counter?

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No. Enzalutamide is a prescription medicine: every Enzalutamide product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Enzalutamide first available?

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The earliest FDA record we hold for Enzalutamide is from 2012: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Enzalutamide was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Enzalutamide on HelloPharmacist

📊Enzalutamide supplement interactions49 checked — ranked by severity 🌿Drug & Supplement CheckerEnzalutamide vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Enzalutamide NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Enzalutamide Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Enzalutamide forms and strengths (how it comes)

Enzalutamide is available in 2 forms. 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.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Enzalutamide inactive ingredients by manufacturer.

Tablet

By mouth
Brands Xtandi
How this form is used
What it may be used for
  • Xtandi tablets are used to treat castration-resistant prostate cancer (CRPC)
  • Xtandi tablets are used to treat metastatic castration-sensitive prostate cancer (mCSPC)
  • Xtandi tablets are used to treat non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis
Important instructions
  • Xtandi tablets are taken by mouth once daily, with or without food
  • Xtandi tablets must be swallowed whole with enough water — do not cut, crush, or chew them
  • Xtandi offers smaller tablet sizes that may be considered for patients who have difficulty swallowing larger forms
  • Take Xtandi tablets at the same time each day and follow your prescriber's instructions
Available strengths 2 strengths
40 mg 80 mg
14 FDA-listed product records ⓘ

Capsule

By mouth
Brands Xtandi
How this form is used
What it may be used for
  • Xtandi capsules are used to treat castration-resistant prostate cancer (CRPC)
  • Xtandi capsules are used to treat metastatic castration-sensitive prostate cancer (mCSPC)
  • Xtandi capsules are used to treat non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis
Important instructions
  • Xtandi capsules are taken by mouth once daily, with or without food
  • Xtandi capsules must be swallowed whole with enough water — do not chew, crush, open, or dissolve them
  • If you have difficulty swallowing, talk to your doctor about switching to a smaller Xtandi tablet size
  • Take Xtandi capsules at the same time each day and follow your prescriber's instructions
Available strengths 1 strength
40 mg
9 FDA-listed product records ⓘ

Enzalutamide on the U.S. market: products, makers and brands

How Enzalutamide 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 Enzalutamide product records with the FDA, mostly as tablet, capsule; the earliest marketing or approval year on record is 2012. Brand names on the directory include Xtandi; the rest are generics.

2
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
5
FDA-listed product records ⓘ
2012
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (20) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Enzalutamide is used (Medicaid data)

A general measure of how commonly Enzalutamide 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 Enzalutamide 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.

9,669
Medicaid prescriptions filled (Q1–Q4 2025)
$137.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Enzalutamide prescribed? Of the 1,601 medications we measure, Enzalutamide ranks #940 by Medicaid prescriptions — more than 41% of them.

Where Enzalutamide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #940 of 1,601
#935 Belatacept Injection 10,001 Rx #936 Naloxone Injection 9,967 Rx #937 Pentosan Polysulfate 9,962 Rx #938 Cefixime 9,945 Rx #939 Meperidine 9,802 Rx #940 Enzalutamide 9,669 Rx #941 Ethambutol 9,534 Rx #942 Potassium Chloride / S... 9,393 Rx #943 Vincristine Injection 9,198 Rx #944 Calcium, Magnesium, Po... 9,091 Rx #945 Aminophylline 9,002 Rx

Utilization by Enzalutamide 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.

The 40 mg oral capsule is the most-dispensed Enzalutamide product — about 38% of these Medicaid prescriptions.

enzalutamide 40 MG Oral Capsule Most dispensed

3,675 Medicaid prescriptions (Q1–Q4 2025) 38% of Enzalutamide prescriptions shown $51.7M gross reimbursement (before rebates) ≈ $14,063 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1307303

enzalutamide 80 MG Oral Tablet

3,525 Medicaid prescriptions (Q1–Q4 2025) 36% of Enzalutamide prescriptions shown $51.1M gross reimbursement (before rebates) ≈ $14,489 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2390648

enzalutamide 40 MG Oral Tablet

2,469 Medicaid prescriptions (Q1–Q4 2025) 26% of Enzalutamide prescriptions shown $34.6M gross reimbursement (before rebates) ≈ $14,019 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2390644

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 Enzalutamide, 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 3 of 6 listed Enzalutamide NDCs with Medicaid activity.

Compare Enzalutamide products

A representative set of FDA-listed product records for Enzalutamide — 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
40 mg Oral Astellas Pharma US, Inc. × 2 listings NDA View NDC →
💊Tablet
40 mg Oral Astellas Pharma US, Inc. × 2 listings NDA View NDC →
80 mg Oral Astellas Pharma US, Inc. NDA View NDC →

Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Enzalutamide NDCs →

Enzalutamide 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 Enzalutamide recalls since July 2021.

✅No Enzalutamide recalls on record since July 2021

Source: 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.

Ingredient (IN) Enzalutamide RxCUI 1307298 2 dose forms · 3 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 1307302 In current FDA listings
    Clinical drug / strength (SCD) 40 MG RxCUI 1307303
  2. Dose form (SCDF) Oral Tablet RxCUI 2390643 In current FDA listings
    Clinical drug / strength (SCD) 40 MG RxCUI 2390644 80 MG RxCUI 2390648

Look up RxCUI 1307298 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.

Enzalutamide brand names

Enzalutamide is sold under one brand name in the FDA directory — Xtandi. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Xtandi

Who makes Enzalutamide: manufacturers and labelers

One company lists Enzalutamide products with the FDA. By number of product records, the largest are Astellas Pharma US, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Astellas Pharma US, Inc. 5

Enzalutamide drug class (RxNorm)

Enzalutamide belongs to the Androgen Receptor Inhibitor class.

Pharmacologic class Androgen Receptor Inhibitor
Drug family (ATC) Anti-androgens
How it works Androgen Receptor Antagonists, Cytochrome P450 3A4 Inducers, Cytochrome P450 2C9 Inducers, Cytochrome P450 2C19 Inducers

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 Enzalutamide 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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 28, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Enzalutamide.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Enzalutamide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
5
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Astellas Pharma US, Inc.
Linked label effective
Jul 28, 2026
Composite sections available
21
Linked SPL Set ID
b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf
Linked SPL Document ID
1cc0ed2a-2c33-4027-90bb-572d717b81d2
Open the linked representative label on DailyMed ↗

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. Astellas Pharma US, 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 →