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Apalutamide

Apalutamide is an androgen receptor inhibitor used to treat metastatic castration-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer.

Brand name Erleada
Rx Form 1
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 5, 2026
Apalutamide 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

Apalutamide (Erleada) is a targeted prostate cancer medicine, on the U.S. market since about 2018. It blocks the androgen receptor (the docking spot testosterone uses to fuel cancer growth) and is always used together with testosterone-lowering treatment under a cancer specialist’s care. It is generally well tolerated, and the side effects people notice most are tiredness, hot flashes, joint aches and rash. Get help quickly for a seizure, a rash that spreads, blisters or peels, or new cough and breathlessness, which can signal lung inflammation. It also raises the risk of heart attack, stroke, falls and fractures, and it weakens many other medicines, so close monitoring matters.

Clinical pearls

  • Swallow the tablets whole; if that is hard, they can be dispersed in water and taken with orange juice or applesauce.
  • If you take digoxin, tell the lab, since apalutamide can make some digoxin blood tests read falsely high.
  • Men with a partner who could become pregnant need effective contraception during treatment and for 3 months after the last dose.
  • If you take thyroid replacement, expect your thyroid levels to be rechecked, because your dose may need adjusting.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet
Earliest FDA record2018
Companies listing it with the FDA1
FDA label last updatedJul 2, 2026
FDA’s strongest warning (boxed)None on the label

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

What Apalutamide is used for

▾

Apalutamide is approved to treat two forms of prostate cancer:

  • Erleada is indicated for metastatic castration-sensitive prostate cancer (mCSPC) — prostate cancer that has spread to distant parts of the body and still responds to testosterone-lowering therapy.
  • Erleada is also indicated for non-metastatic castration-resistant prostate cancer (nmCRPC) — prostate cancer that has stopped responding to standard hormone therapy but has not yet been detected in other organs.
  • In both settings, Erleada is used alongside a GnRH analog (a medicine that lowers testosterone) or in patients who have had surgical removal of the testicles.

How Apalutamide works

▾

Apalutamide is an androgen receptor (AR) inhibitor. Prostate cancer cells rely on testosterone and related hormones to grow, and they do this by activating a protein called the androgen receptor. Apalutamide binds directly to that receptor and blocks it — preventing the hormone signal from entering the cell's nucleus, stopping the cancer's genetic machinery from switching on, and ultimately slowing cell growth while triggering cell death (apoptosis).

The body converts apalutamide into an active metabolite called N-desmethyl apalutamide, which also blocks the androgen receptor (though less potently) and contributes meaningfully to the drug's overall effect.

Apalutamide dosage

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Erleada tablets are taken once daily by mouth, with or without food. Tablets should be swallowed whole — do not crush or split them. For patients who cannot swallow tablets, they can be dispersed in non-carbonated water and taken with orange juice, applesauce, or additional water; the mixture must be used immediately. Erleada can also be given through a feeding tube.

  • Patients with severe liver (hepatic) impairment require a lower dose — follow your prescriber's guidance exactly.
  • If you experience certain side effects, your doctor may pause or reduce your dose temporarily.
  • Always take Erleada exactly as your prescriber directs and do not adjust your dose on your own.

Dosing details from the FDA-approved label

From the Apalutamide 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.

  • Recommended dosage (patients receiving a GnRH analog concurrently or who have had a bilateral orchiectomy)
    • 240 mg orally once daily
    • Swallow the tablet(s) whole
    • Do not crush or split tablet(s)
    • Can be taken with or without food
  • Severe hepatic impairment (Child-Pugh Class C)
    • 120 mg orally once daily
    • Reduced dose for severe hepatic impairment
  • Dosage modification for adverse reactions (Grade 3 or 4 or other intolerable adverse reactions)
    • Withhold ERLEADA
    • For other adverse reactions, resume at the same dose or at a reduced dose (180 mg or 120 mg) when symptoms improve to less than or equal to Grade 1 or original grade, if warranted
    • If dose was reduced while receiving a drug that increases exposure, consider resuming the previously tolerated dose after the drug has been discontinued for at least 3 half-lives
  • Patients who cannot swallow tablets whole (dispersed in water)
    • Place the prescribed dose in a cup
    • For one 240 mg tablet add about 2 teaspoons (10 mL) of non-carbonated water, for 60 mg tablets add about 4 teaspoons (20 mL)
    • Wait 2 minutes, stir, add 2 tablespoons (30 mL) of orange juice, applesauce, or additional water, stir, and swallow immediately
    • Rinse the cup with water and drink it immediately
    • Do not crush or split the tablet(s); do not store the mixture for later use
  • Administration through a feeding tube (8 French or greater)
    • For one 240 mg tablet: place in syringe (at least 20 mL) and draw up 10 mL of non-carbonated water
    • For 60 mg tablets: use at least a 50 mL syringe and draw up 20 mL of non-carbonated water
    • Wait 10 minutes, shake vigorously, administer immediately through the tube, then refill the syringe with non-carbonated water and administer until no residue is left
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION ERLEADA 240 mg orally once daily. Swallow tablets whole. ERLEADA can be taken with or without food. ( 2.1 ) The recommended ERLEADA dosage in patients with severe hepatic impairment is 120 mg orally once daily. ( 2.3 ) Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of ERLEADA is 240 mg orally once daily. ERLEADA can be taken with or without food [see Clinical Pharmacology (12.3) ] . Swallow the tablet(s) whole. Do not crush or split tablet(s). Patients should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had a bilateral orchiectomy. 2.2 Dosage Modifications for Adverse Reactions If Grade 3 or 4 adverse reactions, or other intolerable adverse reactions occur, withhold ERLEADA. Consider permanent discontinuation of ERLEADA for Grade 3 or 4 cerebrovascular and ischemic cardiovascular events [see Warnings and Precautions (5.1) ] . Permanently discontinue ERLEADA for severe ILD/pneumonitis or if no other potential causes of ILD/pneumonitis are identified, or confirmed SCARs, or for other Grade 4 skin reactions [see Warnings and Precautions (5.5 , 5.6) and Adverse Reactions (6.1) ] . For other adverse reactions, including those that may be related to increased exposure to ERLEADA due to drug interactions [see Drug Interactions (7.1) ] , resume ERLEADA at the same dose or at a reduced dose (180 mg or 120 mg) when symptoms improve to less than or equal to Grade 1 or original grade, if warranted. If the ERLEADA dose was reduced for an adverse reaction while receiving a drug that increases exposure to ERLEADA, consider resuming the previously tolerated dose after the drug has been discontinued for at least 3 half-lives. 2.3 Recommended Dosage in Patients with Severe Hepatic Impairment The recommended dosage of ERLEADA for patients with severe hepatic impairment (Child-Pugh Class C) is 120 mg orally once daily [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] .

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

Apalutamide side effects

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The most common side effects reported in clinical trials of Erleada include:

Common side effects

  • Fatigue or weakness
  • Joint pain (arthralgia)
  • Skin rash
  • Decreased appetite or weight loss
  • Falls
  • High blood pressure (hypertension)
  • Hot flashes
  • Diarrhea
  • Itching (pruritus)
  • Nausea
  • Swelling in the legs or feet (peripheral edema)
  • Hypothyroidism (underactive thyroid)

When to get medical help

  • Call your doctor right away if you have chest pain, sudden weakness, trouble speaking, or other signs of a heart attack or stroke
  • Seek help immediately for a seizure — Erleada must be stopped permanently if this happens
  • Get medical help urgently for a spreading rash, blistering, peeling skin, or fever — these could be signs of a rare but life-threatening skin reaction (Stevens-Johnson syndrome or DRESS)
  • Tell your doctor right away if you develop new or worsening shortness of breath, cough, or fever — these may signal a serious lung problem (interstitial lung disease or pneumonitis)
  • Report any new bone fracture to your doctor — fracture risk is increased with this medicine
  • Tell your doctor if you have unexplained falls, especially if you are older

More serious reactions — including seizures, life-threatening skin reactions, lung inflammation, and heart or stroke events — are less common but require immediate medical attention if they occur.

Apalutamide warnings and precautions

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  • Seizures: Seizures occurred in about 0.4% of patients taking Erleada. If you have a seizure, the medicine must be stopped permanently. Avoid activities where a sudden loss of consciousness could be dangerous.
  • Heart attack and stroke: Erleada increases the risk of ischemic heart disease and cerebrovascular events (including events leading to death). Your doctor should monitor your heart health and manage risk factors throughout treatment.
  • Serious skin reactions (SCARs): Rare but potentially fatal reactions — including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and DRESS — have occurred. Watch for spreading rash, blistering, peeling skin, fever, or flu-like symptoms and seek care immediately.
  • Lung inflammation (ILD/pneumonitis): Fatal cases have been reported after approval. Tell your doctor about any new shortness of breath, cough, or fever.
  • Fractures and falls: Both are more common with Erleada, especially in older patients. Fracture risk should be assessed and managed by your care team.
  • Fetal harm: Apalutamide can cause serious harm to a developing fetus. Men with partners who could become pregnant must use effective contraception during treatment and for 3 months after the last dose.
  • Digoxin test interference: Erleada can cause falsely elevated digoxin blood levels on certain lab tests — notify your lab if you take digoxin.

Apalutamide interactions

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Apalutamide has significant interactions with many medications because it strongly affects the liver enzymes and transport proteins that process drugs in the body:

  • Strong CYP2C8 or CYP3A4 inhibitors (e.g., gemfibrozil, ketoconazole, itraconazole) — can increase apalutamide levels in the blood, raising the risk of side effects; a dose adjustment may be needed.
  • CYP3A4 substrates (e.g., many cancer drugs, blood thinners, heart medicines) — apalutamide is a strong CYP3A4 inducer, meaning it can substantially reduce blood levels of these medicines, making them less effective.
  • CYP2C19 substrates — apalutamide strongly induces this pathway too, potentially reducing effectiveness of medicines processed by it.
  • CYP2C9, P-gp, BCRP, and OATP1B1 substrates — apalutamide induces these as well; many common drugs (including certain statins and blood pressure medicines) may be affected.
  • Digoxin blood tests — apalutamide can interfere with certain immunoassay lab tests for digoxin, producing falsely high results; alert your lab.
  • Thyroid hormone replacement — because Erleada can cause hypothyroidism, thyroid replacement therapy may need to be started or adjusted.

Interactions listed in the FDA-approved label

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

  • Strong CYP2C8 or CYP3A4 inhibitors: Co-administration is predicted to increase the steady-state exposure of the active moieties (unbound apalutamide plus the potency-adjusted unbound N-desmethyl-apalutamide). Reduce the ERLEADA dose as recommended for adverse reactions.
  • Substrates of CYP3A4, CYP2C19, CYP2C9, P-gp, BCRP, or OATP1B1: Apalutamide is a strong inducer of CYP3A4 and CYP2C19, a weak inducer of CYP2C9, and an inducer of P-gp, BCRP, and OATP1B1; it decreases exposure of these substrates, which may decrease their effectiveness. Consider alternative agents when possible or evaluate for loss of activity of the substrate if concomitant use cannot be avoided; refer to the Prescribing Information for these substrates.
  • Digoxin immunoassays (laboratory test interference): ERLEADA 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 ERLEADA and digoxin.
Read the label’s full interactions text

7 DRUG INTERACTIONS Concomitant use with medications that are sensitive substrates of CYP3A4, CYP2C19, CYP2C9, UGT, P-gp, BCRP, or OATP1B1 may result in loss of activity of these medications. ( 7.2 ) 7.1 Effect of Other Drugs on ERLEADA Strong CYP2C8 or CYP3A4 Inhibitors Reduce the ERLEADA dose as recommended for adverse reactions [see Dosage and Administration (2.2) ] . Co-administration of a strong CYP2C8 or CYP3A4 inhibitor is predicted to increase the steady-state exposure of the active moieties (sum of unbound apalutamide plus the potency-adjusted unbound N-desmethyl-apalutamide). 7.2 Effect of ERLEADA on Other Drugs Substrates of CYP3A4, CYP2C9, CYP2C19, P-gp, BCRP, or OATP1B1 Refer to the Prescribing Information for these substrates. Consider alternative agents when possible or evaluate for loss of activity of the substrate if concomitant use cannot be avoided. Apalutamide is a strong inducer of CYP3A4 and CYP2C19, a weak inducer of CYP2C9, and an inducer of P-gp, BCRP, and OATP1B1. Apalutamide decreases exposure of substrates of CYP3A4, CYP2C19, CYP2C9, P-gp, BCRP, or OATP1B1 [see Clinical Pharmacology (12.3) ] , which may decrease the effectiveness of these substrates. 7.3 Laboratory Test Interference ERLEADA 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 ERLEADA and digoxin [see Warnings and Precautions (5.8) ] .

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.

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

Before taking Apalutamide

▾
  • Tell your doctor about all prescription and over-the-counter medicines, vitamins, and supplements you take — the interaction risk is broad.
  • Tell your doctor if you have ever had a seizure or have conditions that increase seizure risk.
  • Tell your doctor if you have had a heart attack, stroke, unstable chest pain (angina), or heart failure within the past six months.
  • Men whose partners could become pregnant must use effective contraception during treatment and for 3 months after stopping — this drug can cause fetal harm and pregnancy loss.
  • Apalutamide may reduce fertility in men.
  • Tell your doctor if you have significant liver disease — a lower dose is required for severe liver impairment (Child-Pugh C).
  • Older adults (especially those 75 and over) have a higher risk of falls and serious side effects and should be monitored closely.
  • Erleada has not been studied in children and is not approved for pediatric use.
  • The effect of very low kidney function (eGFR below 30) on apalutamide levels is not fully known; tell your doctor about any kidney problems.

Apalutamide overdose

▾

There is no specific antidote for an apalutamide overdose. If too much is taken, stop the medicine and seek medical attention right away. Treatment is supportive — meaning doctors will manage symptoms until the drug clears from your system.

What Apalutamide does in the body

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In clinical trials, Erleada taken once daily alongside androgen deprivation therapy (ADT) was shown to reduce PSA (prostate-specific antigen — a blood marker for prostate cancer activity) to undetectable levels in a significant proportion of patients with metastatic castration-sensitive prostate cancer. By blocking the androgen receptor, the drug cuts off the hormonal signal that drives prostate cancer cell growth, leading to reduced tumor activity.

How your body processes Apalutamide

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Apalutamide is nearly completely absorbed after oral dosing (close to 100% bioavailability) and reaches peak blood levels in about 2 hours, whether taken with or without food (food may delay peak levels by about 2 hours but does not affect total absorption). It has a half-life of roughly 3 days — meaning it takes several days to clear — and reaches steady-state levels in the blood after about 4 weeks of once-daily dosing. The drug is primarily broken down by liver enzymes (CYP2C8 and CYP3A4) into its active metabolite N-desmethyl apalutamide, and most of the drug is eliminated in the urine, with a smaller portion in the stool. In people with severe liver impairment, drug exposure is significantly increased, which is why a lower dose is used in that group.

How to store Apalutamide

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Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) . Store in original package to protect from light and moisture.

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

155

Supplements & herbs that interact with Apalutamide

155 supplements and herbal products have documented interactions with Apalutamide 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 · 3
  • Moderate · 113
  • Minor · 39
ACTIVATED CHARCOAL Major GRAPEFRUIT Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate ALKANNA Moderate ALPINE RAGWORT Moderate +147 more
Every supplement checked against Apalutamide — ranked by severity The full interaction hub: 3 major · 113 moderate · 39 minor · every one linked to its full report. Check Apalutamide 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.

Apalutamide: pharmacist answers to common questions

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

What exactly is Erleada treating in my case — my doctor mentioned 'castration-sensitive' and 'castration-resistant.' What does that mean?

▾
Those terms describe how your prostate cancer is responding to hormone therapy. 'Castration-sensitive' means the cancer is still being controlled by keeping testosterone levels low — Erleada helps by blocking the testosterone receptor even more completely. 'Castration-resistant' means the cancer has found a way to keep growing even with very low testosterone levels — and again, Erleada steps in to block that pathway more powerfully. Either way, it's working alongside the hormone therapy you're already on.

Can I take Erleada with food, or does it matter?

▾
Good news — it doesn't matter. You can take Erleada with or without food, whichever fits your routine. If you take it with a meal, it might take a little longer to reach peak levels in your blood, but the total amount absorbed is the same. What does matter is swallowing the tablets whole — don't crush or split them. If swallowing is a problem, there's a way to disperse them in water, which your pharmacist can walk you through.

I've heard this medicine can cause a serious rash. How would I know if mine is dangerous?

▾
A skin rash is actually one of the most common side effects — about 1 in 4 patients get some kind of rash, usually appearing within the first few months. Most of the time it can be managed with antihistamines or topical creams. What you want to watch for is anything that feels severe: rash spreading rapidly, blisters or peeling skin, fever, sores in your mouth, or feeling generally unwell like you have the flu at the same time. Those could be signs of a rare but serious reaction called Stevens-Johnson syndrome or DRESS — and if you notice any of those, stop the medicine and get medical help right away. Don't try to ride it out.

My doctor said I need to worry about drug interactions. What kinds of medicines are a problem?

▾
This is a really important one to take seriously. Erleada affects a major liver enzyme system that processes dozens of common medications, which means it can lower the levels of many other drugs in your blood — sometimes enough that they stop working as well. Everything from certain heart medicines and blood thinners to cholesterol medications can be affected. On the flip side, some medicines can raise Erleada levels. Before you start — and any time a new medicine is added — make sure your prescriber and pharmacist have a full list of everything you take, including vitamins and supplements.

I'm worried about the risk of seizures. How likely is this, and what should I do if it happens?

▾
Seizures occurred in about 0.4% of patients in clinical trials — that's roughly 4 in 1,000 people — so it's uncommon but real. The risk is higher if you already have conditions that lower your seizure threshold, which is why your doctor would have screened for that before prescribing. The most important thing to know is this: if you have a seizure, you need to stop Erleada permanently — it cannot be restarted. In the meantime, be cautious about activities where a sudden loss of consciousness could seriously hurt you, like swimming alone or operating heavy machinery. Talk to your doctor about any specific precautions for your situation.

I have a partner who could get pregnant. Do I need to use contraception while on this medicine?

▾
Yes — and this is not optional. Apalutamide can cause serious harm to a developing baby, including fetal abnormalities and pregnancy loss. Even though you're the one taking the medicine, it can be present in semen. You'll need to use effective contraception with your partner throughout your entire treatment and for 3 full months after your last dose. Talk to your doctor about what methods are best for your situation.

Is Apalutamide available over the counter?

▾
No. Apalutamide is a prescription medicine: every Apalutamide 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 Apalutamide first available?

▾
The earliest FDA record we hold for Apalutamide is from 2018: 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 Apalutamide was first used.

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

More about Apalutamide on HelloPharmacist

📊Apalutamide supplement interactions155 checked — ranked by severity 🌿Drug & Supplement CheckerApalutamide vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Apalutamide NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Apalutamide 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.

Apalutamide forms and strengths (how it comes)

Apalutamide 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.

Tablet

By mouth
Brands Erleada
How this form is used
What it may be used for
  • Erleada tablets are used to treat metastatic castration-sensitive prostate cancer (mCSPC)
  • Erleada tablets are used to treat non-metastatic castration-resistant prostate cancer (nmCRPC)
Important instructions
  • Erleada tablets are taken by mouth once daily, with or without food
  • Erleada tablets should be swallowed whole — do not crush or split them
  • If you cannot swallow Erleada tablets whole, they can be dispersed in non-carbonated water and taken with orange juice, applesauce, or additional water — use the mixture immediately and do not save it for later
  • Erleada tablets can also be administered through a feeding tube (8 French or larger) dispersed in non-carbonated water — follow your care team's instructions carefully
Available strengths 2 strengths
60 mg 240 mg
11 FDA-listed product records ⓘ

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

How Apalutamide 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 2 Apalutamide product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2018. Brand names on the directory include Erleada; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
2
FDA-listed product records ⓘ
2018
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (11) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Apalutamide is used (Medicaid data)

A general measure of how commonly Apalutamide 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 Apalutamide 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.

2,841
Medicaid prescriptions filled (Q1–Q4 2025)
$43.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Apalutamide prescribed? Of the 1,601 medications we measure, Apalutamide ranks #1,139 by Medicaid prescriptions — more than 29% of them.

Where Apalutamide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,139 of 1,601
#1,134 Doxycycline Injection 2,893 Rx #1,135 Venetoclax 2,880 Rx #1,136 Amikacin Injection 2,869 Rx #1,137 Inclisiran injection 2,846 Rx #1,138 Potassium Phosphates 2,845 Rx #1,139 Apalutamide 2,841 Rx #1,140 Hydrocortisone Rectal 2,832 Rx #1,141 Betaine 2,821 Rx #1,142 Dihydroergotamine Nasa... 2,813 Rx #1,143 Oxymetazoline Topical 2,766 Rx #1,144 Dasiglucagon Injection 2,752 Rx

Utilization by Apalutamide 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 240 mg oral tablet is the most-dispensed Apalutamide product — about 51% of these Medicaid prescriptions.

apalutamide 240 MG Oral Tablet Most dispensed

1,457 Medicaid prescriptions (Q1–Q4 2025) 51% of Apalutamide prescriptions shown $22.4M gross reimbursement (before rebates) ≈ $15,349 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2630215

apalutamide 60 MG Oral Tablet

1,384 Medicaid prescriptions (Q1–Q4 2025) 49% of Apalutamide prescriptions shown $20.8M gross reimbursement (before rebates) ≈ $14,996 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1999581

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 Apalutamide, 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 2 of 9 listed Apalutamide NDCs with Medicaid activity.

Compare Apalutamide products

A representative set of FDA-listed product records for Apalutamide — 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
💊Tablet
60 mg Oral Janssen Products, LP NDA View NDC →
240 mg Oral Janssen Products, LP NDA View NDC →

Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Apalutamide NDCs →

Apalutamide 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 Apalutamide recalls since July 2021.

✅No Apalutamide 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) Apalutamide RxCUI 1999574 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 1999580 In current FDA listings
    Clinical drug / strength (SCD) 60 MG RxCUI 1999581 240 MG RxCUI 2630215

Look up RxCUI 1999574 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.

Apalutamide brand names

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

Erleada

Who makes Apalutamide: manufacturers and labelers

One company lists Apalutamide products with the FDA. By number of product records, the largest are Janssen Products, LP. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Janssen Products, LP 2

Apalutamide drug class (RxNorm)

Apalutamide belongs to the Anti-androgens class.

Drug family (ATC) Anti-androgens

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 Apalutamide 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.

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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 2, 2026
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Apalutamide.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Apalutamide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
2
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Janssen Products, LP
Linked label effective
Jul 2, 2026
Composite sections available
23
Linked SPL Set ID
d1cda4f7-cb33-46ea-b9ac-431f6452b1a5
Linked SPL Document ID
8934d69e-be91-4552-8fba-ccc07e4f0a20
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. Janssen Products, LP 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 →