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Context, anatomy, and key evidence

← Peptide library

GnRH agonist

Goserelin

Published evidence · coverage incomplete
Anatomical contextAnatomy connections are not mapped yet.

No body region is highlighted until this profile has a supported anatomical connection. This does not mean the peptide has no biological effects.

Read published mechanism findings ↓

At a glance

What is it—and why does it matter?

As a GnRH analogue, ZOLADEX in a biodegradable formulation inhibits pituitary gonadotropin secretion. The contraindication includes known hypersensitivity to GnRH, GnRH agonist analogues, or formulation components of ZOLADEX. The prescribing instructions specify subcutaneous administration of the 10.8 mg goserelin implant every 12 weeks into the anterior abdominal wall below the navel line, using aseptic technique and physician supervision. The labeled indication includes palliative treatment of advanced prostate carcinoma with goserelin (ZOLADEX).

Sources for this introduction: [1] [2] [3] [4]

This published profile is a reference in progress. Findings retain their source context; missing topics are marked below.

What is it?

A molecule, not a product name.

This profile does not yet contain a published summary for this topic. This is a coverage gap, not evidence that no research exists.

How does it work?

Target, response, and disposition.

Mechanism

As a GnRH analogue, ZOLADEX in a biodegradable formulation inhibits pituitary gonadotropin secretion.

Sources[1]dailymedThese highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 3.6 mgInitial U.S. Approval: 1989ZOLADEX acts as an inhibitor of pituitary gonadotropin secretion when administered in the biodegradable formulation.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “ZOLADEX acts as an inhibitor of pituitary gonadotropin secretion when administered in the biodegradable formulation.”

    These highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 3.6 mgInitial U.S. Approval: 1989 · 12.1 Mechanism of Action

    dailymed:294b168b-6e5f-4db9-bf70-d599271458b3:3e673399e4b2:3e673399e4b2

What has been studied?

What the evidence says.

This profile does not yet contain a published summary for this topic. This is a coverage gap, not evidence that no research exists.

Risks and interactions

Risks, organized for scanning.

Contraindications

Use of ZOLADEX is contraindicated during pregnancy, with an exception stated for palliative treatment of advanced breast cancer.

Sources[1]dailymedThese highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 3.6 mgInitial U.S. Approval: 1989ZOLADEX is contraindicated during pregnancy unless ZOLADEX is being used for palliative treatment of advanced breast cancer.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “ZOLADEX is contraindicated during pregnancy unless ZOLADEX is being used for palliative treatment of advanced breast cancer.”

    These highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 3.6 mgInitial U.S. Approval: 1989 · 4.2 Pregnancy

    dailymed:294b168b-6e5f-4db9-bf70-d599271458b3:3e673399e4b2:3e673399e4b2

Contraindications

The contraindication includes known hypersensitivity to GnRH, GnRH agonist analogues, or formulation components of ZOLADEX.

Sources[2]dailymedThese highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 10.8 mgInitial U.S. Approval: 1996ZOLADEX is contraindicated in those patients who have a known hypersensitivity to GnRH, GnRH agonist analogues or any of the components in ZOLADEX
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “ZOLADEX is contraindicated in those patients who have a known hypersensitivity to GnRH, GnRH agonist analogues or any of the components in ZOLADEX”

    These highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 10.8 mgInitial U.S. Approval: 1996 · 4.1 Hypersensitivity

    dailymed:e4cb3c20-2738-400a-b522-3f36f71fe6c5:f613c0937b10:f613c0937b10

Safety findings

Treatment with ZOLADEX is associated with risk of severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome/toxic epidermal necrolysis, DRESS, and acute generalized exanthematous pustulosis.

Sources[1]dailymedThese highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 3.6 mgInitial U.S. Approval: 1989ZOLADEX can cause severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “ZOLADEX can cause severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).”

    These highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 3.6 mgInitial U.S. Approval: 1989 · 5.7 Severe Cutaneous Adverse Reactions

    dailymed:294b168b-6e5f-4db9-bf70-d599271458b3:3e673399e4b2:3e673399e4b2

Products and regulatory status

Same ingredient. Different records.

Regulatory status

ZOLADEX has an indicated pre-procedural role as an endometrial-thinning agent before endometrial ablation in dysfunctional uterine bleeding.

Sources[1]dailymedThese highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 3.6 mgInitial U.S. Approval: 1989ZOLADEX is indicated for use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding[see Dosage and Administration (2.4) and Clinical Studies (14.4)].
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “ZOLADEX is indicated for use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding[see Dosage and Administration (2.4) and Clinical Studies (14.4)].”

    These highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 3.6 mgInitial U.S. Approval: 1989 · 1.4 Endometrial Thinning

    dailymed:294b168b-6e5f-4db9-bf70-d599271458b3:3e673399e4b2:3e673399e4b2

Regulatory status

For Stage T2b–T4 (Stage B2–C) prostate carcinoma, goserelin implant (ZOLADEX) has an indicated use when combined with the antiandrogen flutamide.

Sources[2]dailymedThese highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 10.8 mgInitial U.S. Approval: 1996ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate.”

    These highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 10.8 mgInitial U.S. Approval: 1996 · 1.1 Stage B2-C Prostatic Carcinoma

    dailymed:e4cb3c20-2738-400a-b522-3f36f71fe6c5:f613c0937b10:f613c0937b10

Regulatory status

For women, the 10.8 mg goserelin implant is not indicated, with the stated rationale being insufficient data for reliable serum estradiol suppression.

Sources[2]dailymedThese highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 10.8 mgInitial U.S. Approval: 1996ZOLADEX 10.8 mg implant is not indicated in women as the data are insufficient to support reliable suppression of serum estradiol.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “ZOLADEX 10.8 mg implant is not indicated in women as the data are insufficient to support reliable suppression of serum estradiol.”

    These highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 10.8 mgInitial U.S. Approval: 1996 · 2.4 Women

    dailymed:e4cb3c20-2738-400a-b522-3f36f71fe6c5:f613c0937b10:f613c0937b10

Regulatory status

ZOLADEX has an indicated role in endometriosis management, including symptomatic pain relief and reduction of endometriotic lesions while on therapy.

Sources[1]dailymedThese highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 3.6 mgInitial U.S. Approval: 1989ZOLADEX is indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “ZOLADEX is indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy.”

    These highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 3.6 mgInitial U.S. Approval: 1989 · 1.3 Endometriosis

    dailymed:294b168b-6e5f-4db9-bf70-d599271458b3:3e673399e4b2:3e673399e4b2

Regulatory status

For advanced carcinoma of the prostate, ZOLADEX has an indicated use for palliation.

Sources[1]dailymedThese highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 3.6 mgInitial U.S. Approval: 1989ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate[see Dosage and Administration (2.2) and Clinical Studies (14.2)].
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate[see Dosage and Administration (2.2) and Clinical Studies (14.2)].”

    These highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 3.6 mgInitial U.S. Approval: 1989 · 1.2 Prostatic Carcinoma

    dailymed:294b168b-6e5f-4db9-bf70-d599271458b3:3e673399e4b2:3e673399e4b2

Regulatory status

The labeled indication includes palliative treatment of advanced prostate carcinoma with goserelin (ZOLADEX).

Sources[2]dailymedThese highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 10.8 mgInitial U.S. Approval: 1996ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate”

    These highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 10.8 mgInitial U.S. Approval: 1996 · 1.2 Prostatic Carcinoma

    dailymed:e4cb3c20-2738-400a-b522-3f36f71fe6c5:f613c0937b10:f613c0937b10

Administration context

The practical clinical context.

Administration

The prescribing instructions specify subcutaneous administration of the 10.8 mg goserelin implant every 12 weeks into the anterior abdominal wall below the navel line, using aseptic technique and physician supervision.

Sources[2]dailymedThese highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 10.8 mgInitial U.S. Approval: 1996ZOLADEX, at a dose of 10.8 mg, should be administered subcutaneously every 12 weeks into the anterior abdominal wall below the navel line using an aseptic technique under the supervision of a physician
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “ZOLADEX, at a dose of 10.8 mg, should be administered subcutaneously every 12 weeks into the anterior abdominal wall below the navel line using an aseptic technique under the supervision of a physician”

    These highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 10.8 mgInitial U.S. Approval: 1996 · 2 DOSAGE AND ADMINISTRATION

    dailymed:e4cb3c20-2738-400a-b522-3f36f71fe6c5:f613c0937b10:f613c0937b10

Dose records

In the regimen described for Stage T2b–T4 (Stage B2–C) disease with radiotherapy and flutamide, dosing uses a 3.6 mg goserelin depot followed 28 days later by a 10.8 mg depot.

Sources[2]dailymedThese highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 10.8 mgInitial U.S. Approval: 1996A treatment regimen using one ZOLADEX 3.6 mg depot, followed in 28 days by one ZOLADEX 10.8 mg depot, should be administered.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “A treatment regimen using one ZOLADEX 3.6 mg depot, followed in 28 days by one ZOLADEX 10.8 mg depot, should be administered.”

    These highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 10.8 mgInitial U.S. Approval: 1996 · 2.1 Stage B2-C Prostatic Carcinoma

    dailymed:e4cb3c20-2738-400a-b522-3f36f71fe6c5:f613c0937b10:f613c0937b10

Dose records

The dosing guidance states that renal or hepatic impairment does not require dose adjustment for ZOLADEX.

Sources[2]dailymedThese highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 10.8 mgInitial U.S. Approval: 1996No dosage adjustment is necessary for patients with renal or hepatic impairment.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “No dosage adjustment is necessary for patients with renal or hepatic impairment.”

    These highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 10.8 mgInitial U.S. Approval: 1996 · 2.3 Renal or Hepatic Impairment

    dailymed:e4cb3c20-2738-400a-b522-3f36f71fe6c5:f613c0937b10:f613c0937b10

Dose records

In endometriosis, ZOLADEX is recommended to be administered for a total duration of 6 months.

Sources[1]dailymedThese highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 3.6 mgInitial U.S. Approval: 1989For the management of endometriosis, the recommended duration of administration is 6 months.
Source records
1
Regulatory records
1

Evidence boundary: Applies only to the source-defined population, formulation, dose, and assessment period.

Exact passages, locators, and provenance
  1. supports · Source-backed record
    “For the management of endometriosis, the recommended duration of administration is 6 months.”

    These highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 3.6 mgInitial U.S. Approval: 1989 · 2.3 Endometriosis

    dailymed:294b168b-6e5f-4db9-bf70-d599271458b3:3e673399e4b2:3e673399e4b2

Research status + gaps

What still needs better answers?

  • No publishable claim yet for: effect, identity, interaction
  • 83 compiled claim(s) withheld by automated assurance: assurance_score_below_0.58 (34), assurance_score_below_0.72 (42), current_regulatory_source_required (16), extraction_ambiguity (73), high_risk_requires_regulatory_or_two_independent_sources (45), no_direct_support (74), proposal_not_staged (1)

These are the limits of this profile, not an exhaustive list of scientific uncertainties.

References + discovery

Open the records yourself.

  1. These highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 3.6 mgInitial U.S. Approval: 1989 ↗

    dailymed · published 2026-03-24 · retrieved 2026-09-04T19:33:56Z

  2. These highlights do not include all the information needed to use ZOLADEX safely and effectively.See full prescribing information for ZOLADEX.ZOLADEX®(goserelin implant) 10.8 mgInitial U.S. Approval: 1996 ↗

    dailymed · published 2026-03-24 · retrieved 2026-09-04T19:33:57Z

Publication history and provenance

Version 2 · Automated assessment · 2026-09-04T19:33:57Z

7090dd6945a1c1cb88b04060a2df902a59f01416c85a6103c99641ff968707c6