Is leuprolide FDA-approved?

Yes. Leuprolide is the active ingredient in FDA-approved prescription drug products, and has been since 1985. The FDA-approved labeling for LUPRON DEPOT states that it 'is a gonadotropin releasing hormone (GnRH) agonist indicated for: treatment of advanced prostate cancer.' FDA's Drugs@FDA dataset lists 27 applications containing leuprolide acetate or leuprolide mesylate — 17 new drug applications and 10 abbreviated new drug applications — under brand names including Lupron Depot, Lupron Depot-PED, Eligard, Camcevi and Fensolvi, plus generic leuprolide acetate injection. What that approval does not do is travel. Each application is approved for specific indications in specific populations, and those indications differ product by product: the prostate-cancer labels say nothing about children, and the central-precocious-puberty labels say nothing about adults. 'Leuprolide is approved' is true and is not an answer to 'is this product approved for this person'.

Is Lupron approved for endometriosis?

Yes — but by a different product and a different application than the prostate-cancer Lupron Depot, and the fibroid indication people usually pair it with is narrower than it sounds. The FDA-approved labeling for LUPRON DEPOT 3.75 mg states it is a GnRH agonist indicated for 'Management of endometriosis, including pain relief and reduction of endometriotic lesions' and, 'In combination with a norethindrone acetate for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms.' The same label's second indication is not a treatment for uterine fibroids: it is 'Concomitant use with iron therapy for preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed necessary' — a haematological indication ahead of surgery. The label also tells prescribers to 'Consider a one-month trial period on iron alone, as some women will respond to iron alone.' Total therapy duration is capped by an explicit Limitation of Use because of bone mineral density loss, which the label states may not be fully reversible.

Is Lupron approved as a puberty blocker for gender dysphoria?

No. The approved paediatric indication for leuprolide is central precocious puberty, and only that. FDA-approved labeling states that 'LUPRON DEPOT-PED is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients with central precocious puberty', and that 'FENSOLVI is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.' Neither label carries an indication for gender dysphoria. FDA is aware the drugs are used in that setting and has said so in its own words: in describing the safety review that added a pseudotumor cerebri warning to GnRH agonist labeling, FDA reported six cases and stated that 'Five were undergoing treatment for central precocious puberty and one for transgender care.' Use of an approved drug outside its approved indication is off-label use, which is lawful for a licensed prescriber and is a clinical decision for a patient, a family and that prescriber. What can be said from the documents is narrow and worth saying exactly: no leuprolide label recorded on this page has been reviewed and approved by FDA for this use, so the efficacy and safety findings in those labels are not findings about it.

Did the FDA withdraw approval of Lupron?

One leuprolide application, not the drug. FDA withdrew approval of NDA 203696 — Lupaneta Pack, the co-packaged leuprolide acetate injection and norethindrone acetate tablets from AbbVie Endocrinology Inc. — effective 23 May 2024. FDA states the reason on the record: the applicants 'informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications', waived their opportunity for a hearing, and that the withdrawal 'is without prejudice to refiling'. FDA is not reported in that notice as making any finding about the product's safety or effectiveness. The other 26 leuprolide applications in Drugs@FDA are unaffected and Lupron Depot, Lupron Depot-PED, Eligard, Camcevi and Fensolvi remain approved and marketed. Two other leuprolide products are off the market without any withdrawal of approval: Viadur, and the original 1985 LUPRON injection under NDA 019010, which FDA determined 'was not withdrawn for reasons of safety or effectiveness' and continues to list in the Discontinued Drug Product List section of the Orange Book. That determination is a housekeeping finding that lets generic applications referring to the product continue to be approved — it is not an FDA endorsement of the product, and it is regularly sold as one.

Is leuprolide on FDA's 503A bulk drug substances list?

No — leuprolide appears in none of Categories 1, 2 or 3 of FDA's list of bulk drug substances nominated for use in compounding under section 503A, in the version updated 14 May 2026. That was verified by fetching the document from FDA with a browser user-agent and text-extracting all seven pages: zero hits for 'leuprolide' anywhere in it. Read that absence correctly, because it means the opposite of what the same absence means for a research peptide. The 503A nomination process is a route for bulk substances that are not components of approved drug products; leuprolide is the active ingredient in 26 currently approved applications, so it was never on that track at all. Its absence is therefore not a withdrawal, not a rejection, and not a safety finding — it is a substance that was never in the proceeding. This site records no 503A compounding status for leuprolide for exactly that reason: asserting one would imply a process it was never part of.

Leuprolide

Also sold as: Lupron, Lupron Depot, Lupron Depot-PED, Eligard, Camcevi, Fensolvi, Lupaneta Pack, Viadur, leuprolide acetate, leuprolide mesylate, leuprorelin

Leuprolide is an FDA-approved prescription drug, not an unapproved research peptide: it is a synthetic nonapeptide gonadotropin-releasing hormone (GnRH) agonist that is the active ingredient in products approved under 27 applications in FDA's Drugs@FDA dataset — 17 NDAs and 10 ANDAs — the earliest of which, NDA 019010 (LUPRON injection), FDA states was initially approved on April 9, 1985. The approved indications are narrow and differ by product: Lupron Depot and Eligard are indicated for the treatment of advanced prostate cancer and Camcevi for the treatment of adult patients with advanced prostate cancer; Lupron Depot 3.75 mg for management of endometriosis and, with iron therapy, for preoperative hematologic improvement of women with anemia caused by fibroids; and Lupron Depot-PED and Fensolvi for the treatment of pediatric patients with central precocious puberty, Fensolvi's indication being gated on patients 2 years of age and older. None of the leuprolide labels recorded on this page carries an indication for gender dysphoria, fertility, anti-aging or body composition. FDA withdrew approval of one leuprolide application — NDA 203696, Lupaneta Pack — effective 23 May 2024, after the applicant stated the product was no longer marketed and requested withdrawal; FDA states that withdrawal is 'without prejudice to refiling', and the other twenty-six applications are unaffected. Leuprolide appears in none of Categories 1, 2 or 3 of FDA's 503A bulk drug substances list updated 14 May 2026, an absence that reflects an approved drug that was never on the compounding-nomination track rather than any status. The approved labeling carries substantial warnings, including tumor flare with possible spinal cord compression, cardiovascular and metabolic risk, loss of bone mineral density that the label states may not be fully reversible, and — on the pediatric labels — convulsions, severe cutaneous adverse reactions and pseudotumor cerebri.

Which molecule this is. A synthetic nonapeptide analogue of gonadotropin-releasing hormone (GnRH). The LUPRON DEPOT label describes it as 'a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH)' whose chemical name is '5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate (salt)'. THE SALT DISTINCTION HERE RUNS OPPOSITE TO SEMAGLUTIDE'S, which is why it is worth stating. Two different salts of this peptide are separately FDA-approved: leuprolide ACETATE (Lupron Depot, Lupron Depot-PED, Eligard, Fensolvi and the ANDA products) and leuprolide MESYLATE (Camcevi, NDA 211488 and NDA 219745). The CAMCEVI label gives the identical chemical name ending 'mesylate (salt)' rather than 'acetate (salt)', and Drugs@FDA classifies the original CAMCEVI submission as 'Type 2 - New Active Ingredient'. So a salt change is neither automatically disqualifying nor automatically equivalent: FDA treated the mesylate as a new active ingredient and required its own application, and that application was granted. The question is never whether a salt is 'the same drug' in the abstract — it is whether the specific salt in the specific product has an approved application behind it.

FDA status

FDA-approved

FDA has approved this as a drug. Approval is always for a specific indication and a specific population — check which one, because it is frequently not the use it is marketed for.

FDA-approved, and approved widely — Drugs@FDA lists twenty-seven applications containing leuprolide acetate or leuprolide mesylate, seventeen NDAs and ten ANDAs, enumerated under fdaFindings. The status is not the interesting part of this record. Every one of those approvals is confined to a specific indication and a specific population, and the indications differ product by product: an advanced-prostate-cancer approval says nothing about a child, and a central-precocious-puberty approval says nothing about an adult. Read the approval record below before reading this badge.

LUPRON DEPOT (leuprolide acetate for depot suspension) — Prescribing Information (SPL) — FDA, 15 March 2026

“LUPRON DEPOT is a gonadotropin releasing hormone (GnRH) agonist indicated for: treatment of advanced prostate cancer.”

Checked against the source on 2 August 2026.

Evidence

Proven in humans

Efficacy established by adequate, well-controlled trials in humans.

ADMINISTRATION CHECK RUN, NOT ASSUMED. NCT00660010 was opened and read on 2026-08-02: intervention type DRUG, 'Lupron (leuprolide acetate)', administered by intramuscular injection to 55 paediatric participants with central precocious puberty; Phase 3; enrolment 55 ACTUAL; lead sponsor Abbott; status COMPLETED, primary completion 2009-04 ACTUAL, results first posted 2010-07-20. Leuprolide was GIVEN to human participants — it was not measured as an endogenous biomarker, which is the trap that reduces MOTS-c and TB-500 from an apparent five human RCTs to an actual zero. This registration is independently corroborated by the FDA-approved LUPRON DEPOT-PED label, which names the same NCT number in section 14.1 and reports the same participant count, so the registration is not carrying this claim alone. THE OTHER PIVOTAL PROGRAMMES, NAMED. Endometriosis: section 14.1 of the LUPRON DEPOT 3.75 mg label describes controlled clinical studies against an active comparator (danazol), in which a total of 166 women received LUPRON DEPOT 3.75 mg, plus two add-back studies in which 242 women were treated, one of them randomised and double-blind. Advanced prostate cancer: section 14.1 of the LUPRON DEPOT prostate label describes an 'open-label, non-comparative, multicenter clinical study' in 56 patients with stage D2 prostatic adenocarcinoma. READ THAT LAST ONE PRECISELY, BECAUSE IT IS THE WEAKEST LINK IN THE TIER. The prostate evidence recorded in that label section is single-arm and its primary objective was a SURROGATE — suppression of serum testosterone into the castrate range — with tumour response as a secondary endpoint. That is not a survival comparison, and this record does not claim one. The tier is carried by the paediatric and endometriosis programmes, which are controlled; the prostate section is reported here as what it says it is. SCOPE. The tier attaches to the approved products and the approved indications, and to nothing else. It does not transfer to any use outside those indications, and it does not transfer to material sold under this name that is not an approved product.

Study of Lupron Depot In The Treatment of Central Precocious Puberty — ClinicalTrials.gov, 12 April 2011Checked against the source on 2 August 2026.

What FDA actually approved

Application: NDA 019732 and NDA 020517 (Lupron Depot, advanced prostate cancer); NDA 019943 and NDA 020011 (Lupron Depot 3.75 mg) and NDA 020708 (Lupron Depot 11.25 mg, endometriosis and uterine fibroids); NDA 020263 (Lupron Depot-PED, central precocious puberty); NDA 021343, NDA 021379, NDA 021488 and NDA 021731 (Eligard); NDA 211488 and NDA 219745 (Camcevi, leuprolide mesylate); NDA 213150 (Fensolvi); NDA 205054 (leuprolide acetate for depot suspension); NDA 021088 (Viadur, discontinued); NDA 019010 (Lupron injection, the 1985 original, discontinued); NDA 203696 (Lupaneta Pack, approval withdrawn 2024) — Lupron Depot, Lupron Depot-PED, Eligard, Camcevi, Fensolvi
Approved indication: LUPRON DEPOT is a gonadotropin releasing hormone (GnRH) agonist indicated for: treatment of advanced prostate cancer.

THIS FIELD COVERS ONE LABEL. The indication above is verbatim from the Highlights of the SPL covering NDA 019732 and NDA 020517, and it is the prostate-cancer indication only. The other approved indications — endometriosis, uterine fibroids, and central precocious puberty — are carried by DIFFERENT labels under DIFFERENT applications, and each is recorded verbatim against its own label under fdaFindings rather than paraphrased here. Two things a reader should not infer. (1) 'Leuprolide is approved' is not a statement about any particular product: 'Lupron Depot' alone names products under five NDAs with two entirely different indication sets, one oncological and one gynaecological. The brand name does not identify the approval. (2) `discontinued` is false because the franchise is marketed, but several individual products in the list above are not: Viadur, the 1985 Lupron injection, and Lupaneta Pack are all off the market, the last by withdrawal of approval. The full quotation of this label's section 1 has been shortened to the Highlights sentence under this site's no-dosing policy, because the long form pairs each product strength with its administration interval. No indication is lost in the shortening.

LUPRON DEPOT (leuprolide acetate for depot suspension) — Prescribing Information (SPL) — FDA, 15 March 2026Checked against the source on 2 August 2026.

What FDA found

FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.

Leuprolide acetate or leuprolide mesylate is the active ingredient in products approved under 27 applications in FDA's Drugs@FDA dataset — 17 NDAs and 10 ANDAs. The earliest is NDA 019010 (LUPRON injection), which FDA states was initially approved on April 9, 1985.
The application count is from the Drugs@FDA query recorded in this file's source block, run on 2026-08-02 and returning 27 results; the 1985 approval date is quoted from the Federal Register notice cited here, which is a stronger source for it than a database field. NDAs: 019010, 019732, 019943, 020011, 020263, 020517, 020708, 021088, 021343, 021379, 021488, 021731, 203696, 205054, 211488, 213150, 219745. ANDAs: 074728, 075471, 075721, 078885, 212963, 213829, 215336, 215826, 217437, 217957. A METHOD NOTE THAT MATTERS MORE THAN THE COUNT. Querying openFDA on `openfda.generic_name` returns 20 of these; querying `products.active_ingredients.name` returns all 27. The seven the first query drops include both CAMCEVI applications and LUPANETA PACK — that is, the entire leuprolide mesylate franchise and the one application FDA actually withdrew. A NOT_FOUND or a short count from the wrong field is an artifact of the query, never a fact about the database.
Determination That LUPRON (Leuprolide Acetate) Injection, 1 Milligram/0.2 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness — Federal Register (FDA), 30 May 2019
“LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, is the subject of NDA 019010, held by Abbvie Endocrine, Inc., and initially approved on April 9, 1985.”
Checked against the source on 2 August 2026.
LUPRON DEPOT 3.75 mg is indicated for management of endometriosis, including pain relief and reduction of endometriotic lesions; in combination with norethindrone acetate for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms; and, used concomitantly with iron therapy, for the preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed necessary.
Recorded verbatim because the fibroid indication is routinely reported as 'approved for fibroids', and the label does not say that. What it approves is PREOPERATIVE HEMATOLOGIC IMPROVEMENT of women with anemia caused by fibroids — a haematological indication ahead of surgery, used with iron, not a treatment for the fibroids themselves. The label goes further and tells the prescriber to try iron first: 'Consider a one-month trial period on iron alone, as some women will respond to iron alone.' The same label carries an explicit Limitation of Use stating the product is not indicated for combination use with norethindrone acetate add-back therapy in that preoperative setting. The corresponding LUPRON DEPOT 11.25 mg label (NDA 020708) carries the same two indications in the same wording. Treatment duration is capped by bone-density risk — see safetySignals.
LUPRON DEPOT 3.75 mg (leuprolide acetate for depot suspension) — Prescribing Information (SPL) — FDA, 18 September 2025
“LUPRON DEPOT 3.75 mg is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Endometriosis … Management of endometriosis, including pain relief and reduction of endometriotic lesions. … In combination with a norethindrone acetate for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms. … Uterine Leiomyomata (Fibroids) … Concomitant use with iron therapy for preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed necessary.”
Checked against the source on 2 August 2026.
LUPRON DEPOT-PED is indicated for the treatment of pediatric patients with central precocious puberty (CPP).
The entire paediatric indication, in one sentence. Central precocious puberty is a diagnosis: premature activation of the hypothalamic-pituitary-gonadal axis. It is the only paediatric condition this label approves the product for. Any other use in a child is use outside the approved indication, which is a decision for a licensed prescriber and is not something this label supports — and this site's position on off-label use is the same here as everywhere else: we record what the label says and we do not extend it.
LUPRON DEPOT-PED (leuprolide acetate for depot suspension) — Prescribing Information (SPL) — FDA, 14 November 2025
“LUPRON DEPOT-PED is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients with central precocious puberty. ( 1 )”
Checked against the source on 2 August 2026.
FENSOLVI is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).
Recorded alongside LUPRON DEPOT-PED because the two paediatric leuprolide products do not carry identical indications, and the difference is a hard number: FENSOLVI's indication is gated on 'pediatric patients 2 years of age and older', while LUPRON DEPOT-PED's is not age -gated in its indication statement. Same molecule, same condition, different approved populations, different routes (FENSOLVI subcutaneous, LUPRON DEPOT-PED intramuscular). Neither is substitutable for the other on the strength of the other's label.
FENSOLVI (leuprolide acetate) for injectable suspension — Prescribing Information (SPL) — FDA, 25 September 2025
“FENSOLVI is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.”
Checked against the source on 2 August 2026.
ELIGARD is indicated for the treatment of advanced prostate cancer. CAMCEVI, which contains leuprolide mesylate rather than leuprolide acetate, is indicated for the treatment of adult patients with advanced prostate cancer.
The ELIGARD sentence in the value above is verbatim from the ELIGARD SPL (effectiveTime 2026-04-30), a separate document from this entry's source, and reads in full: 'ELIGARD is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer.' Both are recorded because the prostate-cancer indication is held by three separate franchises under nine NDAs, not by one product. Note CAMCEVI's narrower wording — 'adult patients' — which the LUPRON DEPOT and ELIGARD prostate indications do not contain. ONE DOCUMENTED CHANGE, REPORTED AS AN OBSERVATION AND NOT AS A CONCLUSION: the ELIGARD SPL carrying effectiveTime 2019-04-29 reads 'palliative treatment of advanced prostate cancer', and the current one drops the word 'palliative'. The 2019 Federal Register notice cited elsewhere on this record likewise describes the original LUPRON injection as 'indicated for palliative treatment of advanced prostatic cancer'. This record does not assert why the word changed, and no finding here depends on it.
CAMCEVI (leuprolide mesylate) injectable emulsion — Prescribing Information (SPL) — FDA, 18 February 2026
“CAMCEVI is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer.”
Checked against the source on 2 August 2026.
FDA withdrew approval of NDA 203696 (Lupaneta Pack, leuprolide acetate injection and norethindrone acetate tablets, AbbVie Endocrinology Inc.) effective May 23, 2024. FDA states the applicants informed it that the products were no longer marketed and requested withdrawal, that they waived their opportunity for a hearing, and that withdrawal under 21 CFR 314.150(c) is without prejudice to refiling.
A REAL WITHDRAWAL OF A REAL LEUPROLIDE APPLICATION, and the reason this record's fdaStatus is still 'approved' rather than 'approval-withdrawn'. The withdrawal is scoped to one application out of twenty-seven; sixteen other NDAs and ten ANDAs are untouched. A record that reported this as 'leuprolide's approval was withdrawn' would be false, and a record that omitted it would be hiding the one document that complicates the badge. Read the mechanism, not the headline. This is a Sec. 314.150(c) withdrawal — applicant-requested, on the stated ground that the product is no longer marketed. FDA is not reported here as making any finding about the product's safety or effectiveness, and this record makes none either. Note also what Drugs@FDA shows: NDA 203696's products carry marketing status 'Discontinued', the same string used for products whose approvals are intact. That field does not distinguish 'discontinued' from 'approval withdrawn'. The Federal Register does. The withdrawn product was the endometriosis add-back combination — leuprolide packaged with norethindrone acetate — which is the exact regimen the surviving LUPRON DEPOT 3.75 mg label still describes and still indicates. The combination therapy did not stop being approved; the co-packaged product stopped being sold.
PAI Holdings, LLC DBA Pharmaceutical Associates, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications — Federal Register (FDA), 23 April 2024
“The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under Sec. 314.150(c) is without prejudice to refiling.”
Checked against the source on 2 August 2026.
FDA determined that LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL — NDA 019010, the original 1985 leuprolide product — was not withdrawn from sale for reasons of safety or effectiveness, and continues to list it in the Discontinued Drug Product List section of the Orange Book.
RECORDED BECAUSE THIS IS THE EXACT DOCUMENT TYPE THIS VERTICAL INVERTS. Sermorelin's sellers take a 'not withdrawn for reasons of safety or effectiveness' determination and sell it as an FDA endorsement. It is not one, and the notice says so structurally: FDA explains the finding exists so that generic applications referring to the listed drug can continue to be approved, and states 'This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product.' It is a housekeeping determination about the Orange Book, made on a citizen petition filed by a generic manufacturer (Hetero Labs Limited, Docket FDA-2018-P-4851). It says nothing about whether the product works and nothing about any unapproved use. It does carry one fact worth having: FDA describes this product as 'indicated for palliative treatment of advanced prostatic cancer' — the 1985 approval was oncology, not endocrinology, and every other indication leuprolide now holds came later.
Determination That LUPRON (Leuprolide Acetate) Injection, 1 Milligram/0.2 Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness — Federal Register (FDA), 30 May 2019
“After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under Sec. 314.161 that LUPRON (leuprolide acetate) injection, 1 mg/0.2 mL, was not withdrawn for reasons of safety or effectiveness. … We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.”
Checked against the source on 2 August 2026.
Leuprolide appears in none of Categories 1, 2 or 3 of FDA's list of bulk drug substances nominated for use in compounding under section 503A, updated 2026-05-14.
Recorded to close a misreading, not to assert a status — which is also why this record has no compoundingStatus field. Verified by fetching the document with a browser user-agent and text-extracting all seven pages locally on 2026-08-02: zero hits for 'leuprolide' anywhere in it. This absence means something entirely different from BPC-157's absence. BPC-157 was nominated, sat in Category 2, and left when the nominators withdrew. Leuprolide was never in this system at all — a 503A bulks nomination is a route for substances WITHOUT an approved product, and leuprolide is the active ingredient in twenty-six that survive. Categorical silence here is neither permission nor a safety finding, and asserting 'never-nominated' as a status would imply a proceeding leuprolide was never part of.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on 2 August 2026.

Documented safety signals

Tumor flare. The LUPRON DEPOT prostate label states that, like other GnRH agonists, the product causes an initial increase in serum testosterone during the first weeks of treatment; that patients may experience worsening of symptoms or onset of new signs and symptoms including bone pain, neuropathy, hematuria or bladder outlet obstruction; and that spinal cord compression may contribute to paralysis with or without fatal complications.
The mechanistic point that anyone reading 'GnRH agonist' as 'hormone suppressant' will miss. A GnRH agonist STIMULATES before it suppresses, and in a man with metastatic vertebral disease that transient surge is the dangerous part of the treatment. The label directs close monitoring of patients with metastatic vertebral lesions or urinary tract obstruction. The same initial rise appears on the paediatric labels as 'Initial Rise of Gonadotropins and Sex Steroid Levels', where it presents instead as a transient increase in signs of puberty including vaginal bleeding.
LUPRON DEPOT (leuprolide acetate for depot suspension) — Prescribing Information (SPL) — FDA, 15 March 2026
“Patients may experience worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, or bladder outlet obstruction. Spinal cord compression may contribute to paralysis with or without fatal complications.”
Checked against the source on 2 August 2026.
Metabolic and cardiovascular warnings on the prostate-cancer label: FDA-approved labeling states that use of GnRH agonists may lead to metabolic changes such as hyperglycemia, diabetes mellitus and hyperlipidemia, with non-alcoholic fatty liver disease including cirrhosis occurring in the post-marketing setting; that increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men; and that androgen deprivation therapy may prolong the QT/QTc interval.
Quoted with FDA's own qualifier attached — 'The risk appears low based on the reported odds ratios' — because dropping that clause turns a labelled precaution into a scare, and keeping it while dropping the risk turns a labelled precaution into nothing. Both misreadings circulate. The label's instruction is monitoring, not avoidance.
LUPRON DEPOT (leuprolide acetate for depot suspension) — Prescribing Information (SPL) — FDA, 15 March 2026
“Increased risk of developing myocardial infarction, sudden cardiac death and stroke has been reported in association with use of GnRH agonists in men. The risk appears low based on the reported odds ratios, and should be evaluated carefully along with cardiovascular risk factors when determining a treatment for patients with prostate cancer.”
Checked against the source on 2 August 2026.
Loss of bone mineral density, some of which may not be reversible after stopping treatment. The LUPRON DEPOT 3.75 mg label states that the product induces a hypoestrogenic state resulting in loss of bone mineral density, that the duration of treatment is limited by that risk, that combination use of norethindrone acetate is effective in reducing the loss, that the product is not to be used again without combination norethindrone acetate, and that bone mineral density is to be assessed before retreatment.
The clause that carries the weight is 'some of which may not be reversible after stopping treatment'. This is why the same label caps total therapy duration by a Limitation of Use rather than leaving it to judgement, and it is the reason add-back therapy exists at all. The label also flags additional risk in women with major risk factors for decreased BMD — chronic alcohol use, tobacco use, strong family history of osteoporosis, or chronic use of drugs that can decrease BMD such as anticonvulsants or corticosteroids.
LUPRON DEPOT 3.75 mg (leuprolide acetate for depot suspension) — Prescribing Information (SPL) — FDA, 18 September 2025
“LUPRON DEPOT 3.75 mg induces a hypoestrogenic state that results in loss of bone mineral density (BMD), some of which may not be reversible after stopping treatment.”
Checked against the source on 2 August 2026.
Paediatric warnings and precautions on both approved paediatric labels: psychiatric events reported in patients taking GnRH agonists, including emotional lability such as crying, irritability, impatience, anger and aggression; postmarketing reports of convulsions in patients with and without predisposing conditions; severe cutaneous adverse reactions including Stevens-Johnson syndrome / toxic epidermal necrolysis, DRESS and AGEP, including cases with visceral involvement and/or requiring skin grafts; and pseudotumor cerebri (idiopathic intracranial hypertension).
All four appear in section 5 of the LUPRON DEPOT-PED label quoted here, and all four appear in the same order in section 5 of the FENSOLVI label — verified against both documents on 2026-08-02. The convulsions entry is worth reading closely: the label reports them in patients with predisposing conditions AND, separately, 'in the absence of any of the conditions mentioned above'. Both paediatric labels are also contraindicated in pregnancy and state the product may cause fetal harm.
LUPRON DEPOT-PED (leuprolide acetate for depot suspension) — Prescribing Information (SPL) — FDA, 14 November 2025
“Convulsions: Have been observed in patients with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions. … Pseudotumor Cerebri (Idiopathic Intracranial Hypertension): Have been reported in pediatric patients receiving GnRH agonists, including LUPRON DEPOT-PED. Monitor patients for headache, papilledema, and blurred vision.”
Checked against the source on 2 August 2026.
FDA has stated that it added a warning about the risk of pseudotumor cerebri (idiopathic intracranial hypertension) to the labeling for GnRH agonists approved for the treatment of central precocious puberty in pediatric patients, following a review of post-marketing safety data, the FDA Adverse Event Reporting System and the literature. FDA reported six cases supporting a plausible association, all in birth-assigned females ages 5 to 12, of which five were undergoing treatment for central precocious puberty and one for transgender care, and stated the incidence rate could not be reliably established due to the small number of cases and data limitations.
Recorded with FDA's own limitation attached and nothing added. Six spontaneously reported cases with no denominator is not a rate, and FDA says so in the same document — anyone quoting the six as an incidence is inventing the part that matters. What the six DO establish is why the warning was added, and the labelling change itself is independently confirmed in section 5.5 of both paediatric labels on this record. The one detail worth stating plainly rather than eliding: FDA's own case series records that one of the six patients was receiving a GnRH agonist for transgender care, which is a use no leuprolide label on this record carries an indication for. This site's rule applies unchanged in both directions — we report what the document says, we do not extrapolate from six cases to a population, and we take no position on a clinical decision that belongs to a patient, a family and a licensed prescriber. PROVENANCE, because it is not a standard FDA webpage: the document is hosted at fda.gov/media/159663/download, is headed 'from the Food and Drug Administration', is typed 'FDA Update', names the three FDA offices that contributed, and carries a 2022 American Academy of Pediatrics copyright line. It is FDA-authored content published in AAP News.
Risk of pseudotumor cerebri added to labeling for gonadotropin-releasing hormone agonists — FDA, 1 July 2022
“Six cases were identified that supported a plausible association between GnRH agonist use and pseudotumor cerebri. All six cases were reported in birth-assigned females ages 5 to 12 years. Five were undergoing treatment for central precocious puberty and one for transgender care. … The incidence rate of pseudotumor cerebri associated with GnRH agonist use in pediatric patients could not be reliably established due to the small number of cases and data limitations.”
Checked against the source on 2 August 2026.

Questions people actually ask

Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.

Is leuprolide FDA-approved?: Yes. Leuprolide is the active ingredient in FDA-approved prescription drug products, and has been since 1985. The FDA-approved labeling for LUPRON DEPOT states that it 'is a gonadotropin releasing hormone (GnRH) agonist indicated for: treatment of advanced prostate cancer.' FDA's Drugs@FDA dataset lists 27 applications containing leuprolide acetate or leuprolide mesylate — 17 new drug applications and 10 abbreviated new drug applications — under brand names including Lupron Depot, Lupron Depot-PED, Eligard, Camcevi and Fensolvi, plus generic leuprolide acetate injection. What that approval does not do is travel. Each application is approved for specific indications in specific populations, and those indications differ product by product: the prostate-cancer labels say nothing about children, and the central-precocious-puberty labels say nothing about adults. 'Leuprolide is approved' is true and is not an answer to 'is this product approved for this person'.
LUPRON DEPOT (leuprolide acetate for depot suspension) — Prescribing Information (SPL) — FDA, 15 March 2026
“LUPRON DEPOT is a gonadotropin releasing hormone (GnRH) agonist indicated for: treatment of advanced prostate cancer.”
Checked against the source on 2 August 2026.
Is Lupron approved for endometriosis?: Yes — but by a different product and a different application than the prostate-cancer Lupron Depot, and the fibroid indication people usually pair it with is narrower than it sounds. The FDA-approved labeling for LUPRON DEPOT 3.75 mg states it is a GnRH agonist indicated for 'Management of endometriosis, including pain relief and reduction of endometriotic lesions' and, 'In combination with a norethindrone acetate for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms.' The same label's second indication is not a treatment for uterine fibroids: it is 'Concomitant use with iron therapy for preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed necessary' — a haematological indication ahead of surgery. The label also tells prescribers to 'Consider a one-month trial period on iron alone, as some women will respond to iron alone.' Total therapy duration is capped by an explicit Limitation of Use because of bone mineral density loss, which the label states may not be fully reversible.
LUPRON DEPOT 3.75 mg (leuprolide acetate for depot suspension) — Prescribing Information (SPL) — FDA, 18 September 2025
“Uterine Leiomyomata (Fibroids) … Concomitant use with iron therapy for preoperative hematologic improvement of women with anemia caused by fibroids for whom three months of hormonal suppression is deemed necessary. … Limitations of Use: LUPRON DEPOT 3.75 mg is not indicated for combination use with norethindrone acetate add-back therapy for the preoperative hematologic improvement of women with anemia caused by heavy menstrual bleeding due to fibroids.”
Checked against the source on 2 August 2026.
Is Lupron approved as a puberty blocker for gender dysphoria?: No. The approved paediatric indication for leuprolide is central precocious puberty, and only that. FDA-approved labeling states that 'LUPRON DEPOT-PED is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients with central precocious puberty', and that 'FENSOLVI is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.' Neither label carries an indication for gender dysphoria. FDA is aware the drugs are used in that setting and has said so in its own words: in describing the safety review that added a pseudotumor cerebri warning to GnRH agonist labeling, FDA reported six cases and stated that 'Five were undergoing treatment for central precocious puberty and one for transgender care.' Use of an approved drug outside its approved indication is off-label use, which is lawful for a licensed prescriber and is a clinical decision for a patient, a family and that prescriber. What can be said from the documents is narrow and worth saying exactly: no leuprolide label recorded on this page has been reviewed and approved by FDA for this use, so the efficacy and safety findings in those labels are not findings about it.
FENSOLVI (leuprolide acetate) for injectable suspension — Prescribing Information (SPL) — FDA, 25 September 2025
“FENSOLVI is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.”
Checked against the source on 2 August 2026.
Did the FDA withdraw approval of Lupron?: One leuprolide application, not the drug. FDA withdrew approval of NDA 203696 — Lupaneta Pack, the co-packaged leuprolide acetate injection and norethindrone acetate tablets from AbbVie Endocrinology Inc. — effective 23 May 2024. FDA states the reason on the record: the applicants 'informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications', waived their opportunity for a hearing, and that the withdrawal 'is without prejudice to refiling'. FDA is not reported in that notice as making any finding about the product's safety or effectiveness. The other 26 leuprolide applications in Drugs@FDA are unaffected and Lupron Depot, Lupron Depot-PED, Eligard, Camcevi and Fensolvi remain approved and marketed. Two other leuprolide products are off the market without any withdrawal of approval: Viadur, and the original 1985 LUPRON injection under NDA 019010, which FDA determined 'was not withdrawn for reasons of safety or effectiveness' and continues to list in the Discontinued Drug Product List section of the Orange Book. That determination is a housekeeping finding that lets generic applications referring to the product continue to be approved — it is not an FDA endorsement of the product, and it is regularly sold as one.
PAI Holdings, LLC DBA Pharmaceutical Associates, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications — Federal Register (FDA), 23 April 2024
“The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in Sec. 314.150(c) (21 CFR 314.150(c)). … Withdrawal of approval of an application or abbreviated application under Sec. 314.150(c) is without prejudice to refiling.”
Checked against the source on 2 August 2026.
Is leuprolide on FDA's 503A bulk drug substances list?: No — leuprolide appears in none of Categories 1, 2 or 3 of FDA's list of bulk drug substances nominated for use in compounding under section 503A, in the version updated 14 May 2026. That was verified by fetching the document from FDA with a browser user-agent and text-extracting all seven pages: zero hits for 'leuprolide' anywhere in it. Read that absence correctly, because it means the opposite of what the same absence means for a research peptide. The 503A nomination process is a route for bulk substances that are not components of approved drug products; leuprolide is the active ingredient in 26 currently approved applications, so it was never on that track at all. Its absence is therefore not a withdrawal, not a rejection, and not a safety finding — it is a substance that was never in the proceeding. This site records no 503A compounding status for leuprolide for exactly that reason: asserting one would imply a process it was never part of.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on 2 August 2026.