Prescription medicine
Goserelin Brand names: Zoladex
Goserelin (Zoladex) is a prescription medicine with an FDA approval on record since 1989. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the goserelin FDA label on DailyMed (effective March 24, 2026, TerSera Therapeutics LLC); the NDA 19726 record on Drugs@FDA; every goserelin label on DailyMed.
Highlights of the record
FDA label of March 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate ( 1.1 ) Palliative treatment of advanced carcinoma of the prostate ( 1.2 ) The management of endometriosis ( 1.3 ) Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding ( 1.4 ) Use in the palliative
Forms and strengths
- 3.6 mg
- 10.8 mg
Implant.
On the market
- Earliest approval on file
- December 29, 1989 Zoladex, Tersera; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 13,348 through July 30, 2026
What is goserelin used for?
From the label: indications and usageZOLADEX is a Gonadotropin Releasing Hormone (GnRH) agonist indicated for: Use in combination with flutamide for the management of locally confined carcinoma of the prostate ( 1.1 ) Palliative treatment of advanced carcinoma of the prostate ( 1.2 ) The management of endometriosis ( 1.3 ) Use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding ( 1.4 ) Use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women ( 1.5 ) 1.1 Stage B2-C Prostatic Carcinoma 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. […]
Conditions named in the indications of goserelin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Gonadotropin Releasing Hormone Receptor Agonist.
Source: FDA drug label (ZOLADEX), TerSera Therapeutics LLC, effective March 24, 2026 (SPL set 294b168b-6e5f-4db9-bf70-d599271458b3), via openFDA; the full label on DailyMed
Is there a generic for goserelin (Zoladex)?
No generic goserelin is approved (Drugs@FDA, October 8, 2026).
- 1989 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the goserelin label say about other medicines?
The goserelin label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name goserelin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Testosterone | warnings and precautions | Tumor Flare Phenomenon Initially, ZOLADEX, like other GnRH agonists, causes transient increases in serum levels of testosterone in men with prostate cancer, and estrogen in women with breast cancer. |
Source: FDA drug label (ZOLADEX), TerSera Therapeutics LLC, effective March 24, 2026 (SPL set 294b168b-6e5f-4db9-bf70-d599271458b3), via openFDA; the full label on DailyMed
What do FAERS reports show for goserelin?
The FDA Adverse Event Reporting System holds 13,348 reports that list goserelin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,403 are coded as a death and 3,937 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as goserelin?
2 other medicines are given the same way (subcutaneous) and in the same FDA class as goserelin or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Hyaluronidase and pertuzumab and trastuzumab | Breast cancer | none listed | n/a | No current entry |
| Hyaluronidase and trastuzumab | Breast cancer | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to goserelin
- 2 medicines for the same use
- Other gonadotropin releasing hormone receptor agonists
- the pharmacologic class, with prices and generics
- Goserelin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other