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Darolutamide

Darolutamide is an androgen receptor inhibitor used to treat non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer in adult men.

Brand name Nubeqa
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
Darolutamide 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

Darolutamide (Nubeqa) is a specialist medicine for advanced prostate cancer, on the U.S. market since about 2019, that blocks the androgen receptor (the switch testosterone flips to fuel cancer growth); it is always added to hormone-lowering therapy or prior surgical removal of the testicles, never used alone. Among the newer drugs of its kind it is generally considered one of the easier to tolerate, and tiredness is what people notice most, along with possible rises in blood pressure. The risks to watch for are heart problems and seizures, so get help right away for chest pain, shortness of breath, a racing heart or any seizure.

Clinical pearls

  • Take it with a meal every time, since food greatly increases how much of the medicine your body absorbs.
  • Avoid St. John’s wort and rifampin, which can make darolutamide work less well against the cancer.
  • Darolutamide can raise blood levels of some cholesterol-lowering statins, so your statin dose may need to come down.
  • If a partner could become pregnant, use effective contraception during treatment and for 1 week after the last dose.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet
Earliest FDA record2019
Companies listing it with the FDA1
FDA label last updatedJun 3, 2025
FDA’s strongest warning (boxed)None on the label

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

What Darolutamide is used for

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Darolutamide (available as Nubeqa) is approved to treat specific types of advanced prostate cancer in adult men. All approved uses require concurrent hormone suppression therapy (a GnRH agonist or antagonist, or prior surgical removal of the testicles).

  • Non-metastatic castration-resistant prostate cancer (nmCRPC): Nubeqa is used when prostate cancer continues to grow despite hormone-lowering treatment but has not yet spread to distant organs.
  • Metastatic castration-sensitive prostate cancer (mCSPC): Nubeqa is used when prostate cancer has spread to other parts of the body but still responds to hormone-lowering therapy.
  • mCSPC in combination with docetaxel: Nubeqa can be added to docetaxel chemotherapy for mCSPC. When used this way, the first cycle of docetaxel should be started within 6 weeks of beginning Nubeqa.

How Darolutamide works

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Darolutamide is an androgen receptor (AR) inhibitor. Androgens — hormones like testosterone — normally attach to the androgen receptor inside prostate cancer cells and tell them to grow. Darolutamide blocks this receptor at multiple points: it competes with androgens for the binding site, prevents the receptor from moving into the cell nucleus, and shuts down the gene activity that drives tumor growth. The result is that cancer cells are deprived of the signal they need to multiply.

Darolutamide also converts in the body to an active form called ketodarolutamide, which works similarly and is present at even higher levels in the bloodstream — so both the original drug and its metabolite contribute to the treatment effect.

Darolutamide dosage

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Nubeqa tablets are taken orally twice a day, every day, and must be taken with food — food roughly doubles to triples the amount of medicine your body absorbs, so skipping food is not recommended. Swallow the tablets whole. Treatment continues until the cancer progresses or side effects become unacceptable.

  • If you miss a dose, take it as soon as you remember before your next scheduled dose — do not take two doses together to make up for a missed one.
  • If you have severe kidney disease (not on dialysis) or moderate liver disease, your doctor may prescribe a lower dose.
  • If side effects become severe, your doctor may pause treatment or reduce your dose temporarily — do not adjust your dose on your own.

Dosing details from the FDA-approved label

From the Darolutamide 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 also receiving a GnRH agonist or antagonist, or who have had a bilateral orchiectomy)
    • 600 mg (two 300 mg tablets) taken orally, twice daily, with food
    • Continue until disease progression or unacceptable toxicity occurs
    • Swallow tablets whole with food; take a missed dose as soon as remembered prior to the next scheduled dose and do not take two doses together
  • mCSPC in combination with docetaxel
    • 600 mg (two 300 mg tablets) taken orally, twice daily, with food
    • Administer the first of 6 cycles of docetaxel within 6 weeks after the start of NUBEQA treatment
    • NUBEQA may be continued until disease progression or unacceptable toxicity even if a cycle of docetaxel is delayed, interrupted, or discontinued
  • Grade 3 or greater or intolerable adverse reaction (dosage modification)
    • Withhold NUBEQA or reduce dosage to 300 mg twice daily until symptoms improve
    • May be resumed at 600 mg twice daily when adverse reaction returns to baseline
    • Dosage reduction below 300 mg twice daily is not recommended
  • Severe renal impairment (eGFR 15–29 mL/min/1.73 m2) not receiving hemodialysis
    • 300 mg twice daily
    • Severe renal impairment, not receiving hemodialysis
  • Moderate hepatic impairment (Child-Pugh Class B)
    • 300 mg twice daily
    • Moderate hepatic impairment
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Recommended Dosage : NUBEQA 600 mg (two 300 mg tablets) administered orally twice daily. Swallow tablets whole. Take NUBEQA with food. ( 2.1 ) For patients with mCSPC treated with NUBEQA in combination with docetaxel, administer the first cycle of docetaxel within 6 weeks after the start of NUBEQA treatment. ( 2.1 ) Patients should also receive a gonadotropin-releasing hormone (GnRH) agonist or antagonist concurrently or have had bilateral orchiectomy. ( 2.1 ) 2.1 Recommended Dosage The recommended dose of NUBEQA is 600 mg (two 300 mg tablets) taken orally, twice daily, with food [see Clinical Pharmacology (12.3) ]. Continue treatment until disease progression or unacceptable toxicity occurs. Patients receiving NUBEQA should also receive a gonadotropin-releasing hormone (GnRH) agonist or antagonist concurrently or have had a bilateral orchiectomy. When used in combination with docetaxel for mCSPC, administer the first of 6 cycles of docetaxel within 6 weeks after the start of NUBEQA treatment. Refer to docetaxel prescribing information for additional dosing information, including dosage modifications. Treatment with NUBEQA may be continued until disease progression or unacceptable toxicity, even if a cycle of docetaxel is delayed, interrupted, or discontinued [see Dosage and Administration (2.2) ] . Advise patients to swallow tablets whole with food, to take any missed dose as soon as they remember prior to the next scheduled dose, and not to take two doses together to make up for a missed dose. 2.2 Dosage Modification If a patient experiences a greater than or equal to Grade 3 or an intolerable adverse reaction, withhold NUBEQA or reduce dosage to 300 mg twice daily until symptoms improve. NUBEQA may be resumed at a dose of 600 mg twice daily, when adverse reaction returns to baseline [see Adverse Reactions (6.1) ]. Dosage reduction below 300 mg twice daily is not recommended. For patients who experience ischemic heart disease or seizure, additional dose modifications may be required [ see Warnings and Precautions (5.1 and 5.2) ]. 2.3 Recommended Dosage in Patients with Severe Renal Impairment For patients with severe renal impairment (eGFR 15–29 mL/min/1.73 m 2 ) not receiving hemodialysis, the recommended dose of NUBEQA is 300 mg twice 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 →

Darolutamide side effects

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The most common side effects seen in clinical trials include:

Common side effects

  • Fatigue or weakness
  • Elevated liver enzymes (AST and ALT) on blood tests
  • Low neutrophil count (a type of white blood cell)
  • Elevated bilirubin on blood tests
  • Rash or skin reactions
  • Constipation (when used with docetaxel)
  • High blood pressure
  • Decreased appetite
  • Elevated liver enzymes (AST and ALT) — detected on blood tests, usually without symptoms
  • Low neutrophil count (neutropenia) — reduced ability to fight infection
  • Elevated bilirubin — detected on blood tests
  • Weight gain

When to get medical help

  • Signs of a heart problem — chest pain, shortness of breath, or feeling like your heart is racing or skipping beats: call your doctor right away
  • A seizure (sudden uncontrolled shaking or loss of consciousness): seek emergency help immediately and contact your doctor
  • Signs of liver injury — severe nausea, yellowing of skin or eyes, dark urine, or severe abdominal pain: tell your doctor promptly
  • Unusual bleeding or hemorrhage anywhere in the body: contact your doctor
  • Signs of serious infection such as high fever, chills, or trouble breathing: get medical help

Serious reactions that require prompt medical attention include ischemic heart disease (reduced blood flow to the heart), seizures, significant liver injury, and serious infections. Contact your doctor immediately if you experience chest pain, a seizure, yellowing of the skin or eyes, or signs of serious infection.

Darolutamide warnings and precautions

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  • Ischemic heart disease (reduced blood flow to the heart): This has occurred in patients taking Nubeqa, including fatal cases. Your doctor should actively manage cardiovascular risk factors like high blood pressure, diabetes, and high cholesterol throughout treatment. Nubeqa must be stopped for serious (Grade 3–4) heart events.
  • Seizures: Seizures have been reported, appearing anywhere from weeks to years after starting treatment. It is unknown if anti-seizure medicines prevent this risk. Avoid activities where sudden loss of consciousness could be dangerous. Tell your doctor immediately if you have a seizure — stopping Nubeqa may be necessary.
  • Embryo-fetal toxicity (harm to an unborn baby): Based on how darolutamide works, it can cause fetal harm or pregnancy loss. Men with female partners who could become pregnant must use effective contraception during treatment and for 1 week after the last dose. Animal studies also suggest darolutamide may affect male fertility.

Darolutamide interactions

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Darolutamide interacts with several types of medications that either change how much of the drug gets into your system, or that darolutamide affects in return:

  • Combined P-gp and strong or moderate CYP3A4 inducers (e.g., certain anti-seizure medicines, rifampin, St. John's Wort): these lower darolutamide levels in your blood, which could make it less effective — avoid combining them.
  • Combined P-gp and strong CYP3A4 inhibitors (e.g., certain antifungal or antibiotic medicines): these raise darolutamide levels and may increase the risk of side effects — your doctor will monitor you more frequently and may adjust your dose.
  • BCRP substrate drugs (some statins, certain cancer medicines): darolutamide raises blood levels of these drugs, increasing their side effect risk — avoid the combination if possible; if not, your doctor may reduce the dose of the other medicine.
  • OATP1B1 and OATP1B3 substrate drugs (certain statins and other medicines): darolutamide can raise their blood levels — your doctor will watch for increased side effects and may consider dose reductions.

Interactions listed in the FDA-approved label

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

  • Combined P-gp and strong or moderate CYP3A4 inducers: Decreases darolutamide exposure, which may decrease NUBEQA activity. Avoid concomitant use.
  • Combined P-gp and strong CYP3A4 inhibitors: Increases darolutamide exposure, which may increase the risk of NUBEQA adverse reactions. Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed.
  • BCRP substrates: NUBEQA is an inhibitor of BCRP and increases the AUC and Cmax of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible; if used together, monitor patients more frequently for adverse reactions and consider dose reduction of the BCRP substrate drug.
  • OATP1B1 and OATP1B3 substrates: NUBEQA is an inhibitor of OATP1B1 and OATP1B3 and may increase the plasma concentrations of these substrates. Monitor patients more frequently for adverse reactions and consider dose reduction while taking NUBEQA; review the prescribing information of the substrates.
Read the label’s full interactions text

7 DRUG INTERACTIONS Combined P-gp and Strong or Moderate CYP3A Inducers : Avoid concomitant use. ( 7.1 ) Combined P-gp and Strong CYP3A Inhibitors : Monitor patients more frequently for NUBEQA adverse reactions. ( 7.1 ) BCRP Substrates : Avoid concomitant use with drugs that are BCRP substrates where possible. If used together, monitor patients more frequently for adverse reactions and consider dose reduction of the BCRP substrate drug. ( 7.2 ) OATP1B1 and OATP1B3 Substrates : Concomitant use of NUBEQA may increase the plasma concentrations of OATP1B1 or OATP1B3 substrates. If used together, monitor patients more frequently for adverse reactions and consider dose reduction of these drugs. ( 7.2 ) 7.1 Effects of Other Drugs on NUBEQA Combined P-gp and Strong or Moderate CYP3A4 Inducer Concomitant use of NUBEQA with a combined P-gp and strong or moderate CYP3A4 inducer decreases darolutamide exposure which may decrease NUBEQA activity [see Clinical Pharmacology (12.3) ] . Avoid concomitant use of NUBEQA with combined P-gp and strong or moderate CYP3A4 inducers. Combined P-gp and Strong CYP3A4 Inhibitors Concomitant use of NUBEQA with a combined P-gp and strong CYP3A4 inhibitor increases darolutamide exposure [see Clinical Pharmacology (12.3) ] which may increase the risk of NUBEQA adverse reactions . Monitor patients more frequently for NUBEQA adverse reactions and modify NUBEQA dosage as needed [see Dosage and Administration (2.2) ] . 7.2 Effects of NUBEQA on Other Drugs Breast Cancer Resistance Protein (BCRP) and Organic Anion Transporting Polypeptides (OATP) 1B1 and 1B3 Substrates NUBEQA is an inhibitor of BCRP transporter. Concomitant use of NUBEQA increases the AUC and C max of BCRP substrates [see Clinical Pharmacology (12.3) ], which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use with drugs that are BCRP substrates where possible.

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.

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

Before taking Darolutamide

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  • Heart disease or cardiovascular risk factors: Tell your doctor if you have a history of coronary artery disease, high blood pressure, diabetes, or high cholesterol — these increase the risk of heart-related complications with Nubeqa.
  • History of seizures: Tell your doctor — Nubeqa may further increase seizure risk.
  • Severe kidney disease (not on dialysis): Your exposure to the drug is higher, so a lower dose is recommended; the effect of end-stage kidney disease is not fully known.
  • Moderate liver disease (Child-Pugh Class B): Your exposure to the drug is higher, so a lower dose is recommended; the effect of severe liver disease is not known.
  • Pregnancy and contraception: Darolutamide can cause fetal harm or pregnancy loss. Male patients with partners who could become pregnant must use effective contraception during treatment and for 1 week after the last dose.
  • Fertility: Animal studies suggest darolutamide may impair male fertility — discuss this with your doctor if relevant.
  • Children: Safety and effectiveness have not been established in pediatric patients.
  • Older adults: The majority of patients in clinical trials were 65 or older; no major differences in safety or effectiveness were observed compared to younger adults.

Darolutamide overdose

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There is no specific antidote for a darolutamide overdose. Because the drug reaches a natural absorption ceiling, taking more than the recommended amount is not expected to cause serious systemic toxicity in people with normal kidney and liver function. However, in patients with severe kidney disease or moderate liver disease, if toxicity is suspected after an accidental overdose, Nubeqa should be paused and supportive care provided until symptoms resolve — then treatment can resume on schedule.

What Darolutamide does in the body

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One of the measurable signs that darolutamide is working is a drop in PSA (prostate-specific antigen), a protein produced by prostate cancer cells. In clinical trials, PSA levels fell as doses increased, with the effect plateauing at the standard twice-daily dose. Among patients with nmCRPC on the standard regimen, 24% had undetectable PSA at 12 months, compared to just 0.4% on placebo. Studies did not detect a significant effect on heart rhythm (QTc interval) at the approved dose.

How your body processes Darolutamide

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When taken with food, darolutamide is absorbed over several hours, with blood levels peaking around 4 hours after a dose — food increases absorption by roughly 2 to 2.5 times compared to fasting. The drug reaches steady levels in the body within 2–5 days of regular twice-daily dosing. Darolutamide is primarily broken down by the liver enzyme CYP3A4 and is converted to an active metabolite called ketodarolutamide, which is present at even higher concentrations in the blood. The effective half-life (time for levels to drop by half) is about 20 hours for both darolutamide and ketodarolutamide. Most of the drug is eliminated through the urine and feces, with over 95% cleared within 7 days.

How to store Darolutamide

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Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) .

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

144

Supplements & herbs that interact with Darolutamide

144 supplements and herbal products have documented interactions with Darolutamide 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 · 103
  • Minor · 38
ACTIVATED CHARCOAL Major GRAPEFRUIT Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate AMERICAN ELDER Moderate ASTAXANTHIN Moderate +136 more
Every supplement checked against Darolutamide — ranked by severity The full interaction hub: 3 major · 103 moderate · 38 minor · every one linked to its full report. Check Darolutamide 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.

Darolutamide: pharmacist answers to common questions

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

What exactly is Nubeqa treating — and how is it different from regular hormone therapy?

▾
Nubeqa targets a key protein called the androgen receptor, which is what testosterone and similar hormones attach to in order to fuel prostate cancer growth. Regular hormone therapy lowers the amount of testosterone in your body, but cancer cells can sometimes adapt and keep using the receptor anyway. Nubeqa directly blocks that receptor so cancer cells can't get the growth signal, even when they're trying to resist. It's always used together with hormone-lowering therapy — one treatment complements the other.

Does it matter if I take Nubeqa with food or not?

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Yes — this one really matters. Taking Nubeqa with food roughly doubles to triples the amount of medicine your body actually absorbs. If you take it on an empty stomach, you're not getting the full benefit of your dose. Try to take it consistently with a meal or snack, twice a day. If you accidentally take it without food once, don't panic — just aim to take it with food going forward.

What side effects should I just watch and which ones mean I should call someone right away?

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Many people notice fatigue or mild skin rashes, and blood tests may show changes in liver enzymes or white blood cell counts — your doctor will monitor those regularly. The things to act on quickly are chest pain or shortness of breath (possible heart problem), a seizure or sudden loss of consciousness, severe nausea with yellowing of your skin or eyes (possible liver issue), or signs of serious infection like a high fever. Don't wait it out with those — call your doctor or get to an emergency room.

Are there medications I should avoid while taking Nubeqa?

▾
Yes, a few important ones. Some medicines — including certain seizure drugs, the antibiotic rifampin, and the herbal supplement St. John's Wort — can lower Nubeqa levels in your blood and make it work less well. On the flip side, Nubeqa itself can raise the blood levels of certain other drugs (like some cholesterol-lowering statins), which could increase their side effects. Always give your full medication list — including supplements — to every doctor and pharmacist involved in your care before starting Nubeqa.

I'm in my 70s. Is Nubeqa safe for older patients?

▾
The good news is that most men who took part in the Nubeqa clinical trials were 65 or older — close to half were 75 or older in some studies — and doctors didn't see meaningful differences in safety or effectiveness compared to younger patients. Your doctor will still keep an eye on your heart health and do regular blood tests, which is standard practice regardless of age.

My wife and I were hoping to have a child. Is that still possible while I'm on Nubeqa?

▾
This is an important conversation to have with your doctor before starting treatment. Based on how darolutamide works, it could harm a developing baby, so you'll need to use effective contraception during treatment and for one week after your last dose. Animal studies also suggest the drug may affect male fertility, though the full picture in humans isn't known. If family planning is a priority, talk to your oncologist and possibly a fertility specialist before you begin — they can walk you through your options.

Is Darolutamide available over the counter?

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No. Darolutamide is a prescription medicine: every Darolutamide 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 Darolutamide first available?

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The earliest FDA record we hold for Darolutamide is from 2019: 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 Darolutamide was first used.

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

More about Darolutamide on HelloPharmacist

📊Darolutamide supplement interactions144 checked — ranked by severity 🌿Drug & Supplement CheckerDarolutamide vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Darolutamide NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Darolutamide 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.

Darolutamide forms and strengths (how it comes)

Darolutamide 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 Nubeqa
How this form is used
What it may be used for
  • Nubeqa tablets are used to treat non-metastatic castration-resistant prostate cancer (nmCRPC) in adults
  • Nubeqa tablets are used to treat metastatic castration-sensitive prostate cancer (mCSPC) in adults, alone or in combination with docetaxel chemotherapy
Important instructions
  • Nubeqa tablets must be taken with food — this significantly increases how much medicine your body absorbs
  • Swallow Nubeqa tablets whole; do not crush or chew them
  • Nubeqa is taken twice daily; if you miss a dose, take it as soon as you remember before your next scheduled dose — never take two doses at once
  • Nubeqa tablets are taken alongside a GnRH agonist or antagonist (a hormone-lowering injection) unless you have already had surgical removal of the testicles
Available strengths 1 strength
300 mg
4 FDA-listed product records ⓘ

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

How Darolutamide 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 1 Darolutamide product record with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2019. Brand names on the directory include Nubeqa; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
1
FDA-listed product records ⓘ
2019
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Darolutamide is used (Medicaid data)

A general measure of how commonly Darolutamide 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 Darolutamide 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.

8,087
Medicaid prescriptions filled (Q1–Q4 2025)
$108.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Darolutamide prescribed? Of the 1,601 medications we measure, Darolutamide ranks #968 by Medicaid prescriptions — more than 40% of them.

Where Darolutamide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #968 of 1,601
#963 Niacin 8,285 Rx #964 Flunisolide Nasal Spra... 8,259 Rx #965 Varenicline Nasal Spra... 8,153 Rx #966 IncobotulinumtoxinA In... 8,147 Rx #967 Teriflunomide 8,104 Rx #968 Darolutamide 8,087 Rx #969 Aspirin, Butalbital, a... 8,077 Rx #970 Pemetrexed Injection 8,046 Rx #971 Treprostinil Injection 7,921 Rx #972 Nicotine Nasal Spray 7,853 Rx #973 Cyanocobalamin Nasal G... 7,830 Rx

Utilization by Darolutamide 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.

darolutamide 300 MG Oral Tablet

8,087 Medicaid prescriptions (Q1–Q4 2025) 100% of Darolutamide prescriptions shown $108.3M gross reimbursement (before rebates) ≈ $13,388 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 2180330

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 Darolutamide, 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 3 listed Darolutamide NDCs with Medicaid activity.

Compare Darolutamide products

A representative set of FDA-listed product records for Darolutamide — 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
300 mg Oral Bayer HealthCare Pharmaceuticals Inc. NDA View NDC →

Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Darolutamide NDCs →

Darolutamide 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 Darolutamide recalls since July 2021.

✅No Darolutamide 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) Darolutamide RxCUI 2180325 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Tablet RxCUI 2180329 In current FDA listings
    Clinical drug / strength (SCD) 300 MG RxCUI 2180330

Look up RxCUI 2180325 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.

Darolutamide brand names

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

Nubeqa

Who makes Darolutamide: manufacturers and labelers

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

Bayer HealthCare Pharmaceuticals Inc. 1

Darolutamide drug class (RxNorm)

Darolutamide 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 Darolutamide 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 Jun 3, 2025
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Darolutamide.
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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 Darolutamide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
1
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Bayer HealthCare Pharmaceuticals Inc.
Linked label effective
Jun 3, 2025
Composite sections available
22
Linked SPL Set ID
1a7cb212-56e4-4b9d-a73d-bfee7fe4735e
Linked SPL Document ID
fd96ab4c-d7f4-446f-93d8-1dae246a450a
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. Bayer HealthCare Pharmaceuticals 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 →