Prescription medication · GnRH Agonist
goserelin
Also sold as Zoladex. Zoladex, along with flutamide, can treat prostate cancer that has not spread far.
Data updated 2026-05-15
- 12,855
- FDA reportsModerately reported
- Rx
- Availability
goserelin (Zoladex) is a prescription GnRH Agonist. Zoladex, along with flutamide, can treat prostate cancer that has not spread far.
Zoladex is a medicine that contains goserelin. It is used to treat certain cancers and other health problems by changing hormone levels in your body.
Verify with FDA → · CMS NADAC pricing →
What it does
Zoladex, along with flutamide, can treat prostate cancer that has not spread far.
Common side effects
Hot flashes, Sexual problems, Less firm erections
Key warnings
Zoladex can cause a temporary worsening of tumor symptoms at the start of treatment.
The sections below are summarized in plain English from goserelin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Zoladex is a GnRH agonist. It works by lowering the amount of certain hormones, like testosterone or estrogen, in your body. This can help to slow down the growth of cancer cells or reduce the symptoms of other conditions.
Side Effects (from patient reports)
Based on 12,855 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for goserelin, by number of reports
- Death
Death
1,567 reports
- Malignant Neoplasm Progression
Malignant Neoplasm Progression
1,284 reports
- Fatigue
Fatigue
837 reports
- Metastases To Bone
Metastases To Bone
674 reports
- Neutropenia 608
Neutropenia
608 reports
- Nausea 556
Nausea
556 reports
- Hot Flush 511
Hot Flush
511 reports
- Asthenia 485
Asthenia
485 reports
- Pain 469
Pain
469 reports
- Diarrhoea 459
Diarrhoea
459 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for goserelin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where goserelin sits
goserelin has more FDA adverse-event reports than 45% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is goserelin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 12,855 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
12,855
Reports Mentioning Death
2,371
18.4% of reports — not proof of cause
Hospitalization Reports
3,830
Top Indication
Prostate Cancer
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DEATH | 1,567 |
| 2 | MALIGNANT NEOPLASM PROGRESSION | 1,284 |
| 3 | FATIGUE | 837 |
| 4 | METASTASES TO BONE | 674 |
| 5 | NEUTROPENIA | 608 |
| 6 | NAUSEA | 556 |
| 7 | HOT FLUSH | 511 |
| 8 | ASTHENIA | 485 |
| 9 | PAIN | 469 |
| 10 | DIARRHOEA | 459 |
| 12 | DYSPNOEA | 430 |
| 13 | METASTASES TO LIVER | 424 |
| 14 | ARTHRALGIA | 411 |
| 15 | HEADACHE | 385 |
| 16 | ANAEMIA | 370 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Zoladex can cause a temporary worsening of tumor symptoms at the start of treatment. This may include problems with your kidneys or spinal cord. If you have diabetes, Zoladex may raise your blood sugar. Zoladex may increase the risk of heart attack, stroke, or sudden death. Zoladex can also cause severe skin reactions. Tell your doctor right away if you notice any signs of a severe skin reaction.
Common Questions
Can Zoladex cure my cancer?
Will Zoladex stop my periods?
Can I take other medicines with Zoladex?
How long will I be on Zoladex?
What if I have kidney problems?
Can Zoladex affect my bones?
Will I gain weight on Zoladex?
Can Zoladex cause mood changes?
What if I have an allergic reaction to Zoladex?
Can men continue to have sex while on Zoladex?
What are the common side effects of goserelin?
What drug class is goserelin?
What pregnancy or breastfeeding source fields are listed for goserelin?
Related Medications in GnRH Agonist
Other drugs grouped near goserelin - same-class peers and common alternatives.
abiraterone
Zytiga
Abiraterone (Zytiga) is a medicine used with prednisone to treat prostate cancer that has spread.
Compare with goserelin →
anastrozole
Arimidex
Anastrozole is a medicine used to treat breast cancer in women after menopause.
Compare with goserelin →
bazedoxifene/conjugated estrogens
Duavee
Duavee is a combination medicine containing estrogen and a drug that blocks estrogen in some parts of the body.
Compare with goserelin →
cabergoline
Dostinex
Cabergoline is a medicine that helps lower the amount of prolactin in your body.
Compare with goserelin →
clomiphene
Clomid, Serophene
Clomiphene citrate is a medicine that helps women ovulate.
Compare with goserelin →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for goserelin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 12,855.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 18.44%.
- metaxalone Δ 0.11 pts · 3,268 reports · Muscle Relaxant 18.33%death share
- linezolid Δ 0.14 pts · 28,005 reports · Oxazolidinone Antibiotic 18.58%death share
- gentamicin Δ 0.20 pts · 12,687 reports · Aminoglycoside Antibiotic 18.65%death share
- phytonadione Δ 0.22 pts · 8,078 reports · Vitamin K Supplement 18.67%death share
Medication Guides
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Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for goserelin
The FDA label for goserelin (sold under brand names such as Zoladex) classifies it as a prescription-only medication in the GnRH Agonist class. Zoladex, along with flutamide, can treat prostate cancer that has not spread far. Official labeling lists 14 commonly reported side effects, including Hot flashes, Sexual problems, Less firm erections.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 12,855 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: September 24, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages