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Leuprolide

Leuprolide is a hormone-suppressing injection used to treat advanced prostate cancer in adults and central precocious puberty (early puberty) in children, with certain products also approved for endometriosis and uterine fibroids.

Brand names LupronFensolviCamceviLutrateVabrinty +5 more
Drug class Gonadotropin Releasing Hormone Receptor Agonist
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 13 clinical label sets 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
Other forms & routes:
Injection
Leuprolide 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

Leuprolide is a hormone-suppressing injection, given by a healthcare provider, that drives testosterone and estrogen very low; a mainstay for advanced prostate cancer since about 1989 and available generically, it also treats early puberty in children and, depending on the product, endometriosis and anemia from uterine fibroids. Most people tolerate it well, though the low hormones bring hot flashes, tiredness and lower sex drive. The first weeks matter most, because testosterone briefly spikes before falling (a tumor flare), so new bone pain, leg weakness or trouble urinating needs a call right away. Long term, men face higher risks of heart attack, stroke and high blood sugar, so regular monitoring matters.

Clinical pearls

  • Products run from daily shots to every six months, so write down your exact product and next due date.
  • Leuprolide is not birth control and must not be used in pregnancy, so use a non-hormonal method if pregnancy is possible.
  • Tell any prescriber adding bupropion or an SSRI antidepressant, since the combination may raise seizure risk.
  • Hormone lab results can be thrown off for up to six months after stopping, so mention leuprolide when those tests are ordered.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asInjection
Earliest FDA record1985
Companies listing it with the FDA18
FDA label last updatedFeb 18, 2026
FDA’s strongest warning (boxed)None on the label

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

What Leuprolide is used for

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Leuprolide is a GnRH agonist injection approved across several products for different conditions.

  • Advanced prostate cancer: Camcevi, Eligard, Vabrinty, and Leuprolide Acetate injection are all approved to treat advanced prostate cancer in adult men. Eligard is specifically labeled for palliative (symptom-controlling) treatment.
  • Central precocious puberty (CPP) — early puberty in children: Fensolvi is approved for children 2 years and older with CPP.
  • Endometriosis: Lupron Depot 11.25 mg is approved for managing endometriosis, including pain relief and reduction of lesions — used alone or in combination with norethindrone acetate add-back therapy.
  • Anemia caused by uterine fibroids: Lupron Depot 11.25 mg is approved alongside iron therapy for short-term preoperative improvement in women with anemia caused by fibroids when three months of hormonal suppression is needed.

How Leuprolide works

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Leuprolide mimics GnRH, the brain signal that normally tells the body to produce sex hormones. But when leuprolide is given continuously, the body's receptors become desensitized — and instead of stimulating hormone production, it shuts it down. In men, testosterone falls to castrate levels (very low). In women and children, estrogen production is similarly suppressed. For prostate cancer, low testosterone starves cancer cells that depend on it. For CPP, it pauses the hormone signals driving early puberty.

There is a brief initial surge in testosterone or estrogen in the first one to two weeks before levels fall — this is called the tumor flare effect and is clinically important to monitor, especially in prostate cancer patients.

Leuprolide dosage

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Leuprolide is always given by injection under the skin (subcutaneous) and must be administered by a healthcare provider for most formulations. The injection schedule varies significantly by product and condition.

  • Eligard and Vabrinty (prostate cancer): given subcutaneously on a monthly, every-3-month, every-4-month, or every-6-month schedule depending on the dose chosen.
  • Camcevi (prostate cancer): given subcutaneously once every 6 months.
  • Fensolvi (CPP in children): given subcutaneously once every 6 months.
  • Leuprolide Acetate injection (daily formulation, prostate cancer): given as a once-daily subcutaneous injection with the site rotated each time.

Always follow your prescriber's exact schedule. Do not try to adjust timing on your own.

Dosing details from the FDA-approved label

From the Leuprolide 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.

  • Fensolvi (central precocious pediatric patients; label text says CPP)
    • 45 mg administered by subcutaneous injection once every six months
    • Must be administered by a healthcare provider
    • Discontinue treatment at the appropriate age of onset of puberty
  • Vabrinty 7.5 mg
    • 7.5 mg subcutaneously, 1 injection every month
  • Vabrinty 22.5 mg
    • 22.5 mg subcutaneously, 1 injection every 3 months
  • Vabrinty 30 mg
    • 30 mg subcutaneously, 1 injection every 4 months
  • Vabrinty 45 mg
    • 45 mg subcutaneously, 1 injection every 6 months
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Must be administered by a healthcare provider. ( 2.1 ) The dose of FENSOLVI is 45 mg administered by subcutaneous injection once every six months. ( 2.1 ) Monitor response to FENSOLVI with a GnRH agonist stimulation test, basal serum luteinizing hormone (LH) levels or serum concentration of sex steroid levels at 1 to 2 months following initiation of therapy and as needed to confirm adequate suppression of pituitary gonadotropins, sex steroids, and progression of secondary sexual characteristics. ( 2.2 ) Measure height every 3 to 6 months and monitor bone age periodically. ( 2.2 ) See Full Prescribing Information for reconstitution and administration instructions. ( 2.3 , 2.4 ) 2.1 Dosing Information FENSOLVI must be administered by a healthcare provider. The dose of FENSOLVI is 45 mg administered by subcutaneous injection once every six months. Discontinue FENSOLVI treatment at the appropriate age of onset of puberty. 2.2 Monitoring Monitor response to FENSOLVI with a GnRH agonist stimulation test, basal serum luteinizing hormone (LH) levels or serum concentration of sex steroid levels at 1 to 2 months following initiation of therapy and as needed to confirm adequate suppression of pituitary gonadotropins, sex steroids, and progression of secondary sexual characteristics. Measure height (for calculation of growth velocity) every 3 to 6 months and monitor bone age periodically. Noncompliance with drug regimen or inadequate dosing may lead to gonadotropins and/or sex steroids increasing above prepubertal levels resulting in inadequate control of the pubertal process. If the dose of FENSOLVI is not adequate, switching to an alternative GnRH agonist for the treatment of CPP with the ability for dose adjustment may be necessary. 2.3 Reconstitution Instructions Use aseptic technique including gloves for reconstitution and administration. Allow the product to reach room temperature before reconstitution to allow for easier administration. Once reconstituted, the concentration is 45 mg/0.375 mL. Administer the product within 30 minutes or discard.

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

Leuprolide side effects

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The most commonly reported side effects with leuprolide across products include:

Common side effects

  • Hot flashes or sweating
  • Injection site pain or reaction
  • Fatigue or weakness
  • Nausea or other digestive upset
  • Joint or muscle pain
  • Urinary problems
  • Decreased sex drive or impotence (due to lower hormone levels)
  • Insomnia or sleep problems
  • Decreased sex drive, impotence, or testicular shrinkage (expected effects of lower testosterone)
  • Mood swings or depression

When to get medical help

  • Call your doctor right away if you have new or worsening bone pain, numbness or weakness in the legs, or trouble urinating — these could be signs of a tumor flare or spinal cord compression in the first weeks of treatment
  • Seek emergency care for chest pain, sudden shortness of breath, or signs of stroke (face drooping, arm weakness, speech changes) — GnRH agonists are linked to increased cardiovascular risk in men
  • Tell your doctor immediately if you have a seizure — convulsions have been reported with leuprolide
  • Watch for a spreading rash, blistering skin, or flu-like symptoms with skin changes — these could be signs of a rare but serious skin reaction (Stevens-Johnson syndrome or similar)
  • Report unusual changes in blood sugar symptoms (increased thirst, frequent urination) — leuprolide may raise blood glucose or worsen diabetes
  • Tell your doctor about mood changes, depression, or any thoughts of self-harm — these have been reported in postmarketing experience

Seek medical help right away for signs of a serious skin reaction (blistering, peeling rash), chest pain or stroke symptoms, seizures, or significantly worsening bone or urinary pain in the first weeks of treatment.

Leuprolide warnings and precautions

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  • Tumor flare (first 1–2 weeks): Testosterone spikes briefly at the start of treatment, which can temporarily worsen symptoms — including bone pain, urinary problems, and in rare cases spinal cord compression or paralysis. Patients with spinal metastases or urinary blockage need close early monitoring.
  • Heart risks in men: Use of GnRH agonists like leuprolide is associated with increased risk of heart attack, stroke, and sudden cardiac death. Cardiovascular health should be monitored throughout treatment.
  • Blood sugar and diabetes: Leuprolide can raise blood glucose or worsen existing diabetes. Regular blood sugar monitoring is recommended.
  • Heart rhythm changes: Leuprolide may prolong the QT interval — a measure of heart electrical activity. This is particularly important for patients with existing heart rhythm conditions or those on other QT-prolonging drugs.
  • Seizures: Convulsions have been reported, including in patients with no prior seizure history.
  • Severe skin reactions: Rare but life-threatening skin reactions including Stevens-Johnson syndrome have occurred. Stop the medication and seek care if a spreading rash, blistering, or skin peeling develops.
  • Fetal harm: Leuprolide can cause serious harm to a developing baby and must not be used during pregnancy.

Leuprolide interactions

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Formal drug interaction studies have not been conducted with leuprolide, but the label identifies several important considerations:

  • QT-prolonging drugs: Leuprolide itself can prolong the QT interval (a heart rhythm measure) — combining it with other drugs that do the same raises the risk of dangerous heart arrhythmias. Tell your doctor about all heart medications.
  • Bupropion and SSRIs (antidepressants): These medications have been associated with an increased risk of seizures when used alongside leuprolide.
  • Hormone lab tests: Leuprolide suppresses the pituitary-gonadal system, which can interfere with results of certain hormone tests during treatment and for up to 6 months after stopping.
  • Norethindrone acetate: When Lupron Depot 11.25 mg is used with norethindrone acetate add-back therapy for endometriosis, the contraindications and precautions for norethindrone acetate also apply.

Interactions listed in the FDA-approved label

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

  • Drug-drug interactions (LUPRON DEPOT-PED): No pharmacokinetic-based drug-drug interaction studies have been conducted with LUPRON DEPOT-PED.
  • Diagnostic tests of pituitary gonadotropic and gonadal functions: Therapeutic doses suppress the pituitary-gonadal system, so these tests conducted during treatment and up to six months after discontinuation may be affected. Normal pituitary-gonadal function is usually restored within six months after treatment is discontinued.
Read the label’s full interactions text

Drug Interactions No pharmacokinetic-based drug-drug interaction studies have been conducted with leuprolide acetate. However, because leuprolide acetate is a peptide that is primarily degraded by peptidase and not by cytochrome P-450 enzymes as noted in specific studies, and the drug is only about 46% bound to plasma proteins, drug interactions would not be expected to occur.

Drug Interactions See CLINICAL PHARMACOLOGY, Pharmacokinetics section.

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.

Check Leuprolide against a supplement or herb →

Before taking Leuprolide

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  • Tell your doctor if you have heart disease, congestive heart failure, or a history of abnormal heart rhythms (including long QT syndrome) — leuprolide can affect heart electrical activity.
  • Tell your doctor if you have diabetes or pre-diabetes — leuprolide may raise blood sugar levels.
  • Tell your doctor if you have a history of seizures, epilepsy, or stroke — convulsions have occurred with leuprolide use.
  • Pregnancy: Leuprolide must not be used during pregnancy — it can cause fetal abnormalities and early pregnancy loss. It is not a contraceptive; use non-hormonal birth control if needed during treatment.
  • Breastfeeding: It is not known whether leuprolide passes into breast milk. Discuss the risks and benefits with your provider.
  • Tell your doctor if you have undiagnosed abnormal uterine bleeding — this is a contraindication for the Lupron Depot formulation used in endometriosis.
  • Tell your doctor about all medications you take, especially antidepressants or anything that affects heart rhythm.
  • For children: Fensolvi is approved for CPP in children 2 years and older. Monitor height every 3–6 months and check bone age periodically during treatment.

Leuprolide overdose

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In animal studies, very high doses of leuprolide caused breathing difficulty, reduced activity, and irritation at the injection site — but these doses were far above anything used in humans. In early human clinical studies, high daily doses given for up to two years did not produce side effects different from those seen at standard doses.

What Leuprolide does in the body

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After the first dose of leuprolide, testosterone levels in men temporarily rise before falling. With continued treatment, testosterone drops to castrate levels (at or below 50 ng/dL) — typically within two to four weeks. In clinical studies with Eligard, nearly all patients reached castrate testosterone levels within one month of starting treatment, and levels stayed suppressed throughout therapy. Leuprolide is not active when taken by mouth and must be injected.

How your body processes Leuprolide

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After a subcutaneous injection, leuprolide is absorbed quickly — blood levels peak within about 1 to 5 hours depending on the formulation, then decline gradually as the drug is slowly released from its polymer depot. The drug is broken down into smaller inactive fragments (not by the cytochrome P-450 enzyme system, so most standard drug metabolism interactions are unlikely). The terminal half-life after intravenous dosing is about 3 hours, but depot formulations release the drug slowly over weeks to months. Less than 5% of the dose is excreted unchanged in the urine.

How to store Leuprolide

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Store below 77°F (25°C). Do not freeze. Protect from light.

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

Leuprolide: pharmacist answers to common questions

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

Why does my doctor say my symptoms might get worse right after starting leuprolide?

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That's a really common concern, and it's smart to ask. When you first start leuprolide, your testosterone levels actually spike for a week or two before the drug kicks in and brings them down. This temporary rise — sometimes called a 'tumor flare' — can briefly worsen things like bone pain or urinary symptoms. It usually settles on its own, but your doctor will watch you closely during those first few weeks. If you notice new or significantly worse symptoms, especially bone pain, leg weakness, or trouble urinating, call your care team right away.

Will I get hot flashes? I thought that was just a women's issue.

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Hot flashes are actually one of the most common side effects in men taking leuprolide — over half of men in clinical studies experienced them. Because leuprolide drops testosterone to very low levels, your body reacts the same way it does during menopause. Sweating, sudden warmth, and flushing are real and common. They tend to be most bothersome early in treatment. Let your care team know how you're managing — there are strategies that can help.

Is my child safe on Fensolvi for early puberty? How long will they need it?

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Fensolvi is specifically approved for children 2 and older with central precocious puberty, and it's designed to pause puberty until the appropriate age. It's given as a subcutaneous injection every 6 months by a healthcare provider. Your child's doctor will monitor hormone levels, height, and bone age regularly to make sure things are on track. Treatment is stopped when your child reaches the appropriate age for puberty to begin, and the effects are expected to reverse after stopping.

Can I get pregnant while on leuprolide?

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Leuprolide is not safe during pregnancy — it can cause serious harm to a developing baby, including birth defects and early pregnancy loss. And despite lowering hormone levels, it is not a contraceptive, so pregnancy is still possible. If you could become pregnant, use a non-hormonal form of birth control while on this medication. If you think you might be pregnant, tell your doctor immediately.

Are there any heart risks I should know about?

▾
Yes, and it's worth being upfront about this. In men, long-term use of hormone-suppressing drugs like leuprolide has been linked to a small but real increased risk of heart attack, stroke, and sudden cardiac death. Leuprolide can also affect heart rhythm (a measure called the QT interval). Your doctor will weigh these risks against the benefits of treatment, especially if you already have heart disease. Make sure your care team knows about all your heart medications and any cardiac history so they can monitor you appropriately.

Will leuprolide affect my blood sugar?

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It can. Leuprolide has been associated with higher blood sugar levels and an increased risk of developing diabetes in men — or making blood sugar harder to control if you already have diabetes. Your doctor should check your blood sugar regularly while you're on this medication. If you notice symptoms like unusual thirst, more frequent urination, or unexplained fatigue, let your doctor know.

Is Leuprolide available over the counter?

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

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The earliest FDA record we hold for Leuprolide is from 1985: 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 Leuprolide was first used.

Who makes Leuprolide?

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18 companies currently list Leuprolide products in the FDA's NDC Directory, including AbbVie Inc., TOLMAR Inc., Uronova Pharmaceuticals, Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

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

More about Leuprolide on HelloPharmacist

🌿Drug & Supplement CheckerLeuprolide vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Leuprolide NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Leuprolide 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.

Leuprolide forms and strengths (how it comes)

Leuprolide 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.

Injection

By injection · Under the skin
Brands Camcevi Eligard Fensolvi Vabrinty
How this form is used
What it may be used for
  • Camcevi is used to treat advanced prostate cancer in adult men
  • Eligard is used for palliative treatment of advanced prostate cancer in adult men
  • Fensolvi is used to treat central precocious puberty (early puberty) in children 2 years and older
  • Vabrinty is used to treat advanced prostate cancer in adult men
Important instructions
  • Camcevi, Eligard, Fensolvi, and Vabrinty must all be administered by a healthcare provider — not self-injected at home
  • Eligard and Vabrinty are given subcutaneously on schedules ranging from once monthly to once every 6 months depending on the dose selected
  • Fensolvi is given as a subcutaneous injection once every 6 months
  • Leuprolide Acetate injection (daily formulation) is given as a once-daily subcutaneous injection with the injection site rotated periodically
Available strengths 14 strengths
1 mg/0.2 mL 3.75 mg/mL 7.5 mg/0.25 mL 7.5 mg/mL 11.25 mg/1.5 mL 11.25 mg/mL
Show 8 more strengths Show fewer strengths
15 mg/mL 22.5 mg/0.375 mL 22.5 mg/1.5 mL 30 mg/0.5 mL 30 mg/1.5 mL 42 mg/0.37 g 45 mg/0.375 mL 45 mg/1.5 mL
38 FDA-listed product records ⓘ

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

How Leuprolide 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.

18 companies list 42 Leuprolide product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 1985. Brand names on the directory include Lupron, Fensolvi, Camcevi and 7 more; the rest are generics.

1
Dose forms ⓘ
18
Labelers (makers, repackagers, distributors)
9
Brand names
42
FDA-listed product records ⓘ
1985
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Kit (75) · Powder (51) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

AbbVie Inc.29%
TOLMAR Inc.24%
Uronova Pharmaceuticals, Inc.10%
Accord BioPharma, Inc.5%
Amneal Pharmaceuticals LLC2%
Avyxa Pharma, LLC2%
Other makers29%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Leuprolide is used (Medicaid data)

A general measure of how commonly Leuprolide 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 Leuprolide 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.

63,703
Medicaid prescriptions filled (Q1–Q4 2025)
$207.6M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Leuprolide prescribed? Of the 1,601 medications we measure, Leuprolide ranks #582 by Medicaid prescriptions — more than 64% of them.

Where Leuprolide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #582 of 1,601
#577 Glucagon Injection / S... 66,185 Rx #578 Selenium Sulfide 65,979 Rx #579 Pantoprazole Injection 65,430 Rx #580 Ertapenem Injection 65,406 Rx #581 Bismuth Subsalicylate 65,273 Rx #582 Leuprolide Injection 63,703 Rx #583 Leuprolide 63,703 Rx #584 Acyclovir Topical 63,555 Rx #585 Human Immunoglobulin G 63,159 Rx #586 Ramipril 63,139 Rx #587 Belimumab Injection 62,832 Rx

Utilization by Leuprolide 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 1 mL / 3.75 mg/mL prefilled syringe is the most-dispensed Leuprolide product — about 19% of these Medicaid prescriptions.

1 ML leuprolide acetate 3.75 MG/ML Prefilled Syringe Most dispensed

12,106 Medicaid prescriptions (Q1–Q4 2025) 19% of Leuprolide prescriptions shown $21M gross reimbursement (before rebates) ≈ $1,737 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1115457

1.5 ML leuprolide acetate 15 MG/ML Prefilled Syringe

11,734 Medicaid prescriptions (Q1–Q4 2025) 18% of Leuprolide prescriptions shown $23.2M gross reimbursement (before rebates) ≈ $1,974 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 1115467

1 ML leuprolide acetate 7.5 MG/ML Prefilled Syringe

10,150 Medicaid prescriptions (Q1–Q4 2025) 16% of Leuprolide prescriptions shown $8.9M gross reimbursement (before rebates) ≈ $875 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 1115462

0.375 ML leuprolide acetate 60 MG/ML Prefilled Syringe

7,850 Medicaid prescriptions (Q1–Q4 2025) 12% of Leuprolide prescriptions shown $4.4M gross reimbursement (before rebates) ≈ $554 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 752894

1.5 ML leuprolide acetate 7.5 MG/ML Prefilled Syringe

4,719 Medicaid prescriptions (Q1–Q4 2025) 7% of Leuprolide prescriptions shown $21.2M gross reimbursement (before rebates) ≈ $4,485 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1115472

0.375 ML leuprolide acetate 120 MG/ML Prefilled Syringe

3,948 Medicaid prescriptions (Q1–Q4 2025) 6% of Leuprolide prescriptions shown $28.5M gross reimbursement (before rebates) ≈ $7,230 per prescription (gross)

Summed across the 4 of 7 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 752884

0.25 ML leuprolide acetate 30 MG/ML Prefilled Syringe

3,000 Medicaid prescriptions (Q1–Q4 2025) 5% of Leuprolide prescriptions shown $853,064 gross reimbursement (before rebates) ≈ $284 per prescription (gross)

Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 752899

1.5 ML leuprolide acetate 30 MG/ML Prefilled Syringe

2,709 Medicaid prescriptions (Q1–Q4 2025) 4% of Leuprolide prescriptions shown $8.2M gross reimbursement (before rebates) ≈ $3,016 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 1115257

3-Month 1.5 ML leuprolide acetate 20 MG/ML Prefilled Syringe

2,549 Medicaid prescriptions (Q1–Q4 2025) 4% of Leuprolide prescriptions shown $31.1M gross reimbursement (before rebates) ≈ $12,199 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1946519

Pediatric 1.5 ML leuprolide acetate 30 MG/ML Prefilled Syringe

1,691 Medicaid prescriptions (Q1–Q4 2025) 3% of Leuprolide prescriptions shown $42.7M gross reimbursement (before rebates) ≈ $25,227 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2639668

Pediatric 1.5 ML leuprolide acetate 7.5 MG/ML Prefilled Syringe

1,171 Medicaid prescriptions (Q1–Q4 2025) 2% of Leuprolide prescriptions shown $12.4M gross reimbursement (before rebates) ≈ $10,590 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2639749

leuprolide 42 MG Prefilled Syringe

562 Medicaid prescriptions (Q1–Q4 2025) <1% of Leuprolide prescriptions shown $1M gross reimbursement (before rebates) ≈ $1,833 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2595044

1 ML leuprolide acetate 15 MG/ML Prefilled Syringe

480 Medicaid prescriptions (Q1–Q4 2025) <1% of Leuprolide prescriptions shown $2.2M gross reimbursement (before rebates) ≈ $4,482 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1115454

4-Month 1.5 ML leuprolide acetate 20 MG/ML Prefilled Syringe

416 Medicaid prescriptions (Q1–Q4 2025) <1% of Leuprolide prescriptions shown $1.1M gross reimbursement (before rebates) ≈ $2,673 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 1946521

0.5 ML leuprolide acetate 60 MG/ML Prefilled Syringe

283 Medicaid prescriptions (Q1–Q4 2025) <1% of Leuprolide prescriptions shown $183,849 gross reimbursement (before rebates) ≈ $650 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 752889

1 ML leuprolide acetate 11.25 MG/ML Prefilled Syringe

178 Medicaid prescriptions (Q1–Q4 2025) <1% of Leuprolide prescriptions shown $633,454 gross reimbursement (before rebates) ≈ $3,559 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1115447

leuprolide acetate 5 MG/ML Injectable Solution

105 Medicaid prescriptions (Q1–Q4 2025) <1% of Leuprolide prescriptions shown $20,322 gross reimbursement (before rebates) ≈ $194 per prescription (gross)

Summed across the 3 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 545835

Pediatric 1 ML leuprolide acetate 7.5 MG/ML Prefilled Syringe

52 Medicaid prescriptions (Q1–Q4 2025) <1% of Leuprolide prescriptions shown $108,923 gross reimbursement (before rebates) ≈ $2,095 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2639742

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 Leuprolide, 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 27 of 71 listed Leuprolide NDCs with Medicaid activity.

Compare Leuprolide products

A representative set of FDA-listed product records for Leuprolide — 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.)

Showing 42 of 42 products — FDA National Drug Code Directory. See every product, package size and price: browse all 42 Leuprolide NDCs →

Leuprolide 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 one Leuprolide recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class III Sep 12, 2023 · Terminated · Tolmar, Inc.
Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product.
  • Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, Sterile, Rx Only, Must be reconstituted before use, NDC 62935-753-75, Manufactured by: Tolmar Inc., Fort Collins, CO 80526,… Lots: Lot: 13635A1, Exp. 07/31/2024 FDA record D-1178-2023 →

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) Leuprolide RxCUI 42375 4 dose forms · 22 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 372576 In current FDA listings
    Clinical drug / strength (SCD) acetate 5 MG/ML RxCUI 545835
  2. Dose form (SCDF) Injectable Suspension RxCUI 378232 In current FDA listings
    Clinical drug / strength (SCD) acetate 120 MG/ML RxCUI 583425 acetate 20 MG/ML RxCUI 545848 acetate 7.5 MG/ML RxCUI 1116124
  3. Dose form (SCDF) Injection RxCUI 2606515 In current FDA listings
    Clinical drug / strength (SCD) acetate 22.5 MG RxCUI 2606516
  4. Dose form (SCDF) Prefilled Syringe RxCUI 727599 No current FDA listing
    Clinical drug / strength (SCD) Pediatric 1 ML leuprolide acetate 7.5 MG/ML RxCUI 2639742 Pediatric 1.5 ML leuprolide acetate 30 MG/ML RxCUI 2639668 Pediatric 1.5 ML leuprolide acetate 7.5 MG/ML RxCUI 2639749 0.25 ML leuprolide acetate 30 MG/ML RxCUI 752899 0.375 ML leuprolide acetate 120 MG/ML RxCUI 752884 0.375 ML leuprolide acetate 60 MG/ML RxCUI 752894 0.5 ML leuprolide acetate 60 MG/ML RxCUI 752889 1 ML leuprolide acetate 11.25 MG/ML RxCUI 1115447 1 ML leuprolide acetate 15 MG/ML RxCUI 1115454 1 ML leuprolide acetate 3.75 MG/ML RxCUI 1115457 1 ML leuprolide acetate 7.5 MG/ML RxCUI 1115462 1.5 ML leuprolide acetate 15 MG/ML RxCUI 1115467 1.5 ML leuprolide acetate 30 MG/ML RxCUI 1115257 1.5 ML leuprolide acetate 7.5 MG/ML RxCUI 1115472 3-Month 1.5 ML leuprolide acetate 20 MG/ML RxCUI 1946519 4-Month 1.5 ML leuprolide acetate 20 MG/ML RxCUI 1946521 42 MG RxCUI 2595044

Look up RxCUI 42375 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.

Leuprolide brand names

Leuprolide is sold under 10 brand names in the FDA directory — Lupron, Fensolvi, Camcevi, Lutrate and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Lupron Fensolvi Camcevi Lutrate Vabrinty Eligard Lupron Depot Lupron Depot-PED Leuprolide Acetate Depot Lutrate Depot

Who makes Leuprolide: manufacturers and labelers

18 companies list Leuprolide products with the FDA. By number of product records, the largest are AbbVie Inc., TOLMAR Inc., Uronova Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

AbbVie Inc. 12 TOLMAR Inc. 10 Uronova Pharmaceuticals, Inc. 4 Accord BioPharma, Inc. 2 Amneal Pharmaceuticals LLC 1 Avyxa Pharma, LLC 1 Cipla Usa Inc. 1 Endo USA, Inc. 1 Eugia US LLC 1 Meitheal Pharmaceuticals Inc 1 NorthStar RxLLC 1 PAI Holdings, LLC dba PAI Pharma 1 Sandoz Inc 1 Sun Pharmaceutical Industries, Inc. 1 UBI Pharma Inc. 1 VGYAAN Pharmaceuticals LLC 1 Zydus Lifesciences Limited 1 Zydus Pharmaceuticals USA Inc. 1

Leuprolide drug class (RxNorm)

Leuprolide belongs to the Gonadotropin Releasing Hormone Receptor Agonist class.

Pharmacologic class Gonadotropin Releasing Hormone Receptor Agonist
Drug family (ATC) Gonadotropin releasing hormone analogues
How it works Gonadotropin Releasing Hormone Receptor Agonists

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 Leuprolide 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 Feb 18, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Leuprolide.
📈
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 Leuprolide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
13
Finished products in the current FDA directory
42
Companies listing them (makers, repackagers, distributors)
18
FDA labeler codes behind them ⓘ
18
Linked representative label ⓘ
Accord BioPharma, Inc.
Linked label effective
Feb 18, 2026
Composite sections available
25
Linked SPL Set ID
d7a8761a-d953-413a-e053-2a95a90a60ee
Linked SPL Document ID
4b1ada65-9911-eacf-e063-6394a90af9d9
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

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. Accord BioPharma, 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 →