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Relugolix

Relugolix is a GnRH receptor antagonist used to treat advanced prostate cancer in adults.

Brand name Orgovyx
Drug class Gonadotropin Releasing Hormone Receptor Antagonist
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
Relugolix 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

Relugolix (Orgovyx) treats advanced prostate cancer by blocking GnRH receptors in the pituitary gland, which rapidly drives down testosterone, the hormone that fuels the cancer; on the market since about 2020, it is a once-daily oral alternative to the usual hormone injections. It is usually well tolerated for a hormone therapy, though hot flashes, tiredness and joint, back or muscle aches are common. Watch for an irregular heartbeat, dizziness or fainting, since it can lengthen the QT interval (the heart's electrical recharge time) and set off a dangerous rhythm. Swelling of the face, lips or throat is uncommon but means stopping it and getting medical help right away.

Clinical pearls

  • Swallow the tablet whole without crushing or chewing; food does not matter, so taking it with breakfast is fine.
  • Skip a dose that is over 12 hours late; after a break over 7 days, restarting needs a higher first-day dose.
  • Flag any new antibiotic or antifungal, especially erythromycin or rifampin, since these can push relugolix levels sharply up or down.
  • Men with partners who could become pregnant need effective contraception during treatment and for 2 weeks after the last dose.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet
Earliest FDA record2020
Companies listing it with the FDA1
FDA label last updatedOct 10, 2025
FDA’s strongest warning (boxed)None on the label

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

What Relugolix is used for

▾

Relugolix is approved for use in the following condition:

  • Orgovyx (oral tablet): Treatment of advanced prostate cancer in adult men — it works by reducing testosterone, a hormone that drives prostate cancer cell growth

How Relugolix works

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Relugolix is a GnRH receptor antagonist — it competes for and blocks GnRH receptors in the pituitary gland. Normally, GnRH signals the pituitary to release LH (luteinizing hormone) and FSH (follicle-stimulating hormone), which in turn tell the testes to produce testosterone. By blocking this signaling chain, relugolix causes a rapid, sustained drop in testosterone to castrate levels (below 50 ng/dL). Prostate cancer cells are fueled by testosterone, so cutting off that supply helps slow or stop tumor growth.

In clinical trials, more than half of patients reached castrate testosterone levels within 4 days of starting treatment, and 97% maintained those levels through 48 weeks. After stopping treatment, testosterone levels can begin recovering — about 55% of patients in a substudy saw testosterone return toward normal range within 90 days of stopping.

Relugolix dosage

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Orgovyx is taken by mouth once daily, at roughly the same time each day. It can be taken with or without food. Tablets must be swallowed whole — do not crush or chew them.

  • If you miss a dose by more than 12 hours, skip it and take your next scheduled dose as usual
  • If treatment is interrupted for more than 7 days, your prescriber will restart with a higher first-day (loading) dose before returning to the regular daily dose
  • If you need to take a P-gp inhibitor drug for a short time, your prescriber may briefly pause Orgovyx for up to 2 weeks

Dosing details from the FDA-approved label

From the Relugolix 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.

  • Prostate cancer (recommended dosage)
    • Loading dose of 360 mg on the first day, followed by 120 mg taken orally once daily at approximately the same time each day
    • Can be taken with or without food; swallow tablets whole, do not crush or chew
  • Treatment interrupted for greater than 7 days
    • Restart with a loading dose of 360 mg on the first day, and continue with a dose of 120 mg once daily
    • Missed dose: take as soon as remembered; if missed by more than 12 hours, skip it and resume with next scheduled dose
  • Co-administration with oral P-gp inhibitors (unavoidable)
    • Take ORGOVYX first and separate dosing by at least 6 hours
    • Treatment may be interrupted for up to two weeks if a short course of a P-gp inhibitor is required, then resume after the inhibitor is discontinued
    • Monitor patients for increased adverse reactions; if interrupted for greater than 7 days, restart with 360 mg loading dose then 120 mg once daily
  • Co-administration with combined P-gp and strong CYP3A inducers (unavoidable)
    • Increase the ORGOVYX dose to 240 mg once daily
    • After the inducer is discontinued, resume 120 mg once daily
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Recommended Dosage: A loading dose of 360 mg on the first day of treatment followed by 120 mg taken orally once daily, at approximately the same time each day ( 2.1 ). ORGOVYX can be taken with or without food ( 2.1 , 12.3 ). Instruct patients to swallow tablets whole and not to crush or chew tablets ( 2.1 ). 2.1 Recommended Dosage Initiate treatment of ORGOVYX with a loading dose of 360 mg on the first day and continue treatment with a 120 mg dose taken orally once daily at approximately the same time each day. ORGOVYX can be taken with or without food [see Clinical Pharmacology ( 12.3 )] . Instruct patients to swallow tablets whole and not to crush or chew tablets. Advise patients to take a missed dose of ORGOVYX as soon as they remember. If the dose was missed by more than 12 hours, patients should not take the missed dose and resume with the next scheduled dose. If treatment with ORGOVYX is interrupted for greater than 7 days, restart ORGOVYX with a loading dose of 360 mg on the first day, and continue with a dose of 120 mg once daily. In patients treated with GnRH receptor agonists and antagonists for prostate cancer, treatment is usually continued upon development of nonmetastatic or metastatic castration-resistant prostate cancer. 2.2 Dosage Modifications for P-gp Inhibitors Avoid co-administration of ORGOVYX with oral P-gp inhibitors. If co-administration is unavoidable, take ORGOVYX first and separate dosing by at least 6 hours [ see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 ) ] . Monitor patients for increased adverse reactions. Treatment with ORGOVYX may be interrupted for up to two weeks if a short course of treatment with a P-gp inhibitor is required. Resume ORGOVYX after the P-gp inhibitor is discontinued. If treatment with ORGOVYX is interrupted for greater than 7 days, restart ORGOVYX with a loading dose of 360 mg on the first day and continue with a dose of 120 mg once daily. 2.3 Dosage Modifications for Combined P-gp and Strong CYP3A Inducers Avoid co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers. If co-administration is unavoidable, increase the ORGOVYX dose to 240 mg once daily. After discontinuation of the combined P-gp and strong CYP3A inducer, resume the recommended ORGOVYX dose of 120 mg once daily [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] .

Read the full Dosage and Administration section on DailyMed →

Relugolix side effects

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The most commonly reported side effects with Orgovyx include:

Common side effects

  • Hot flushes (hot flashes)
  • Musculoskeletal pain (joint, back, or muscle pain)
  • Fatigue or weakness
  • Constipation
  • Diarrhea
  • Elevated blood sugar (glucose) on lab tests
  • Elevated triglycerides (blood fats) on lab tests
  • Decreased hemoglobin (mild anemia) on lab tests

When to get medical help

  • Call your doctor right away if you have chest pain, shortness of breath, or symptoms of a heart attack or stroke
  • Seek immediate help if you notice swelling of the face, lips, tongue, or throat (signs of a severe allergic reaction called angioedema)
  • Tell your doctor about any irregular heartbeat, dizziness, or fainting — Orgovyx can affect the heart's electrical rhythm (QT interval)
  • Report any signs of a severe hypersensitivity (allergic) reaction, including hives or difficulty breathing
  • Contact your doctor if you notice significant weight gain, breast enlargement (gynecomastia), new or worsening depression, or sleep problems

More serious reactions — including heart attack, stroke, severe allergic reactions (angioedema), and arrhythmia (irregular heartbeat) — were reported in a small percentage of patients and require immediate medical attention.

Relugolix warnings and precautions

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  • Heart rhythm (QT interval prolongation): Orgovyx, like other androgen deprivation therapies, can slow the heart's electrical recharge time. This is a particular concern if you already have congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, or take other medicines that affect heart rhythm. Your prescriber may monitor your heart (ECG) and blood electrolytes periodically.
  • Severe allergic reactions (hypersensitivity): Reactions including pharyngeal edema (throat swelling) and angioedema (facial/throat swelling) have been reported. If you experience swelling, difficulty swallowing or breathing, or hives, temporarily stop Orgovyx and seek medical care immediately. Severe reactions require permanent discontinuation.
  • Fetal harm (embryo-fetal toxicity): Based on animal studies and how the drug works, Orgovyx can cause serious harm to a developing fetus. Male patients with female partners who could become pregnant must use effective contraception during treatment and for 2 weeks after the last dose.
  • Cardiovascular events: Heart attacks and strokes (fatal and non-fatal combined) were reported in about 2.7% of patients taking Orgovyx in clinical trials.
  • Lab monitoring: Orgovyx suppresses the pituitary-gonadal hormone system, which can affect results of related hormone tests. PSA (prostate-specific antigen) and testosterone levels should be monitored periodically during treatment.

Relugolix interactions

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Several drugs can significantly affect how Orgovyx works in your body — always give your prescriber and pharmacist a full list of your medications:

  • P-gp inhibitors (drugs that block the P-glycoprotein transporter, e.g., erythromycin): These can raise Orgovyx blood levels substantially, increasing the risk of side effects. Avoid combining them; if unavoidable, take Orgovyx first and separate the doses by at least 6 hours.
  • Combined P-gp and strong CYP3A inducers (e.g., rifampin): These lower Orgovyx blood levels, potentially making it less effective against prostate cancer. Avoid this combination; if unavoidable, your prescriber will adjust the Orgovyx dose.
  • Drugs that prolong the QT interval (affect heart rhythm): Combining these with Orgovyx could increase the risk of dangerous heart rhythm changes. Your prescriber should weigh the risks carefully.

Interactions listed in the FDA-approved label

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

  • Oral P-gp inhibitors: Relugolix is a P-gp substrate; co-administration increases relugolix exposure, which may increase the risk of adverse reactions. Avoid co-administration. If unavoidable, take ORGOVYX first, separate dosing by at least 6 hours, and monitor for increased adverse reactions. Treatment may be interrupted for up to two weeks if a short course of a P-gp inhibitor is required.
  • Combined P-gp and strong CYP3A inducers: Relugolix is a P-gp and CYP3A substrate; co-administration decreases relugolix exposure, which may reduce the effects of ORGOVYX. Avoid co-administration. If unavoidable, increase the ORGOVYX dose to 240 mg once daily; after the inducer is discontinued, resume 120 mg once daily.
Read the label’s full interactions text

7 DRUG INTERACTIONS P-gp Inhibitors: Avoid co-administration. If unavoidable, take ORGOVYX first, separate dosing by at least 6 hours, and monitor patients more frequently for adverse reactions ( 2.2 , 7.1 ). Combined P-gp and Strong CYP3A Inducers: Avoid co-administration. If unavoidable, increase the ORGOVYX dose to 240 mg once daily ( 2.3 , 7.1 ). 7.1 Effect of Other Drugs on ORGOVYX P-gp Inhibitors Relugolix is a P-gp substrate. Co-administration of ORGOVYX with an oral P-gp inhibitor increases relugolix exposure [see Clinical Pharmacology ( 12.3 )], which may increase the risk of adverse reactions associated with ORGOVYX. Avoid co-administration of ORGOVYX with oral P-gp inhibitors. If co-administration with an oral P-gp inhibitor cannot be avoided, take ORGOVYX first and separate dosing by at least 6 hours. Monitor patients for increased adverse reactions [see Dosage and Administration ( 2.2 )] . Treatment with ORGOVYX may be interrupted for up to two weeks if a short course of treatment with a P-gp inhibitor is required. Resume ORGOVYX after the P-gp inhibitor is discontinued. If treatment with ORGOVYX is interrupted for greater than 7 days, restart ORGOVYX with a loading dose of 360 mg on the first day and continue with a dose of 120 mg once daily. Combined P-gp and Strong CYP3A Inducers Relugolix is a P-gp and CYP3A substrate. Co-administration of ORGOVYX with a combined P-gp and strong CYP3A inducer decreases relugolix exposure, which may reduce the effects of ORGOVYX [see Clinical Pharmacology ( 12.3 )]. Avoid co-administration of ORGOVYX with combined P-gp and strong CYP3A inducers. If co-administration cannot be avoided, increase the ORGOVYX dose. After discontinuation of the combined P-gp and strong CYP3A inducer, resume ORGOVYX once daily at the same dose [see Dosage and Administration ( 2.3 )] .

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.

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

Before taking Relugolix

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  • Severe hypersensitivity to relugolix: Orgovyx is contraindicated (must not be used) if you have had a severe allergic reaction to relugolix or any ingredient in the product.
  • Heart conditions: Tell your doctor if you have congenital long QT syndrome, congestive heart failure, or frequent electrolyte imbalances — the risk of heart rhythm problems may be higher.
  • Reproductive partners: Male patients with female partners who could become pregnant must use effective contraception during treatment and for 2 weeks after stopping. Orgovyx may also impair male fertility.
  • Children: Safety and effectiveness in pediatric patients have not been established.
  • Older adults: Most patients studied were 65 or older; no dose adjustment is needed based on age alone, and no meaningful differences in safety or effectiveness were seen compared with younger patients.
  • Kidney disease: Mild-to-severe kidney impairment does not significantly affect how the drug is processed; however, the effect of end-stage kidney disease (dialysis) has not been studied.
  • Liver disease: Mild-to-moderate liver impairment does not significantly affect drug levels; severe liver impairment (Child-Pugh C) has not been studied.
  • All medications: Tell your prescriber and pharmacist about all prescription and over-the-counter medicines, especially antibiotics, antifungals, rifampin, or any medicine that affects heart rhythm.

What Relugolix does in the body

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Relugolix rapidly lowers levels of LH, FSH, and testosterone after the first dose. In clinical trials, more than half of patients reached castrate-level testosterone (below 50 ng/dL) by day 4, and 97% maintained those levels through 48 weeks of treatment. After stopping Orgovyx, testosterone can begin to recover — about 55% of patients in a substudy who did not receive additional hormone therapy reached testosterone levels above the lower limit of normal within 90 days. Studies at the recommended doses did not show a clinically significant effect on the QT interval (the heart's electrical recharge time) from relugolix itself.

How your body processes Relugolix

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Relugolix is taken by mouth and reaches peak blood levels in about 2 to 2.5 hours on average. It can be taken with or without food — a high-fat meal does not meaningfully change how much of the drug reaches your system. The effective half-life (the time it takes your body to clear half the drug) is about 25 hours, which supports once-daily dosing. Relugolix is broken down mainly by the CYP3A enzyme in the liver, and most of the drug leaves the body through the stool (feces), with a small amount through urine.

How to store Relugolix

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Store ORGOVYX at room temperature. store above 30°C (86°F). Keep out of reach of children.

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

152

Supplements & herbs that interact with Relugolix

152 supplements and herbal products have documented interactions with Relugolix 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 · 8
  • Moderate · 107
  • Minor · 37
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major ARSENIC Major CESIUM Major EPHEDRA Major GRAPEFRUIT Major SIDA CORDIFOLIA Major ST. JOHN'S WORT Major +144 more
Every supplement checked against Relugolix — ranked by severity The full interaction hub: 8 major · 107 moderate · 37 minor · every one linked to its full report. Check Relugolix 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.

Relugolix: pharmacist answers to common questions

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

What is Orgovyx actually doing to treat my prostate cancer?

▾
Orgovyx works by blocking signals in your brain that normally tell your body to make testosterone. Prostate cancer cells need testosterone to grow, so by driving testosterone down to very low levels — what doctors call castrate levels — the drug helps slow or stop the cancer's progression. In studies, most men reached those low testosterone levels within just a few days of starting the medication.

Can I take my Orgovyx tablet with breakfast, or does it have to be on an empty stomach?

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Good news — you can take it with or without food, whichever works best for your routine. The most important thing is to take it at roughly the same time each day. Just remember to swallow the tablet whole. Don't crush or chew it.

What side effects should I actually expect on this medication?

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Hot flashes are by far the most common — more than half of men in the clinical trial experienced them. Muscle or joint pain, fatigue, constipation, and diarrhea are also pretty common. Your doctor will also watch your blood sugar and blood fat levels with lab tests, as those can rise during treatment. Most of these are manageable, but tell your care team what you're experiencing so they can help.

Are there any side effects that mean I should call someone right away?

▾
Yes — a few things warrant immediate attention. If you have chest pain, sudden shortness of breath, or symptoms of a stroke, call 911. If you notice rapid swelling of your face, lips, tongue, or throat, that could be a serious allergic reaction called angioedema — stop the medication and get medical help right away. Also tell your doctor about any new irregular heartbeat, fainting, or dizziness, since Orgovyx can affect your heart's electrical rhythm.

Are there other medications I need to be careful about while taking Orgovyx?

▾
Yes, this is really important. Some drugs — including certain antibiotics like erythromycin and the antibiotic rifampin — can either raise or lower the amount of Orgovyx in your bloodstream. That can make the medication less effective or increase side effects. Make sure your prescriber and pharmacist know every medicine you take, including over-the-counter drugs and supplements, before starting Orgovyx.

My partner and I want to have children someday. Does this medication affect that?

▾
Orgovyx may affect your fertility while you're taking it, based on how the drug works. More urgently, if your partner could become pregnant, you need to use effective contraception during treatment and for 2 weeks after your last dose — studies in animals showed the drug can cause serious harm to a developing fetus. Talk openly with your doctor about your family planning goals so they can factor that into your care.

Is Relugolix available over the counter?

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

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The earliest FDA record we hold for Relugolix is from 2020: 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 Relugolix was first used.

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

More about Relugolix on HelloPharmacist

📊Relugolix supplement interactions152 checked — ranked by severity 🌿Drug & Supplement CheckerRelugolix vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Relugolix NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Relugolix 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.

Relugolix forms and strengths (how it comes)

Relugolix 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 Orgovyx
How this form is used
What it may be used for
  • Orgovyx is used to treat advanced prostate cancer in adult men
  • Orgovyx lowers testosterone to castrate levels, helping to slow prostate cancer growth
Important instructions
  • Orgovyx is taken by mouth once daily at approximately the same time each day
  • Orgovyx can be taken with or without food
  • Swallow Orgovyx tablets whole — do not crush or chew them
  • If Orgovyx is interrupted for more than 7 days, your prescriber will restart treatment with a higher first-day loading dose
Available strengths 1 strength
120 mg
4 FDA-listed product records ⓘ

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

How Relugolix 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 Relugolix product record with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2020. Brand names on the directory include Orgovyx; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
1
FDA-listed product records ⓘ
2020
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (9) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Relugolix is used (Medicaid data)

A general measure of how commonly Relugolix 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 Relugolix 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.

6,636
Medicaid prescriptions filled (Q1–Q4 2025)
$18.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Relugolix prescribed? Of the 1,601 medications we measure, Relugolix ranks #1,000 by Medicaid prescriptions — more than 38% of them.

Where Relugolix ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,000 of 1,601
#995 Diroximel Fumarate 6,829 Rx #996 Octreotide Injection 6,763 Rx #997 Olaparib 6,734 Rx #998 Blinatumomab Injection 6,717 Rx #999 Neostigmine Methylsulf... 6,649 Rx #1,000 Relugolix 6,636 Rx #1,001 Ketamine 6,625 Rx #1,002 Baricitinib 6,573 Rx #1,003 Nizatidine 6,555 Rx #1,004 Panitumumab Injection 6,524 Rx #1,005 Ampicillin Injection 6,519 Rx

Utilization by Relugolix 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.

relugolix 120 MG Oral Tablet

6,636 Medicaid prescriptions (Q1–Q4 2025) 100% of Relugolix prescriptions shown $18.6M gross reimbursement (before rebates) ≈ $2,796 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2472783

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 Relugolix, 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 4 listed Relugolix NDCs with Medicaid activity.

Compare Relugolix products

A representative set of FDA-listed product records for Relugolix — 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
120 mg Oral Sumitomo Pharma America, Inc. NDA View NDC →

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

Relugolix 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 Relugolix recalls since July 2021.

✅No Relugolix 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) Relugolix RxCUI 2472778 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Tablet RxCUI 2472782 In current FDA listings
    Clinical drug / strength (SCD) 120 MG RxCUI 2472783

Look up RxCUI 2472778 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.

Relugolix brand names

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

Orgovyx

Who makes Relugolix: manufacturers and labelers

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

Sumitomo Pharma America, Inc. 1

Relugolix drug class (RxNorm)

Relugolix belongs to the Gonadotropin Releasing Hormone Receptor Antagonist class.

Pharmacologic class Gonadotropin Releasing Hormone Receptor Antagonist
Drug family (ATC) Other hormone antagonists and related agents
How it works Gonadotropin Releasing Hormone Receptor Antagonists, P-Glycoprotein Inhibitors, Cytochrome P450 2B6 Inducers, Breast Cancer Resistance Protein Inhibitors

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 Relugolix 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 Oct 10, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Relugolix.
📈
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 Relugolix 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 ⓘ
Sumitomo Pharma America, Inc.
Linked label effective
Oct 10, 2025
Composite sections available
21
Linked SPL Set ID
077a92f6-9f1b-479a-87c7-c92b5db6aa9c
Linked SPL Document ID
0d9200dd-878e-4e93-98af-e1149e84c21f
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. Sumitomo Pharma America, 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 →