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goserelin

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Brand names: Zoladex

GnRH Agonist Rx

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.

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.

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.

How to Take It

Zoladex is given as a shot under the skin of your belly every 28 days. A doctor or nurse will give you the shot. Try to get the shot on time, but a few days' delay is okay. For endometriosis, the treatment usually lasts 6 months.

Pregnancy & Breastfeeding

You should not take Zoladex if you are pregnant, unless it is for breast cancer treatment. Zoladex can harm your unborn baby, so use birth control while taking it and for 12 weeks after stopping. It is not known if Zoladex passes into breast milk, so talk to your doctor about breastfeeding.

Missed Dose

If you miss a Zoladex injection, contact your doctor as soon as possible to reschedule.

Storage

Store Zoladex at room temperature, away from heat and moisture.

Side Effects (from patient reports)

Based on 7,451 FDA adverse event reports.

Death
1,567
Cancer getting worse
1,284
Tiredness
837
Cancer spreading to the bones
674
Low white blood cell count
608
Feeling sick to your stomach
556
Hot flashes
511
Weakness
485
Pain
470
Diarrhea
459

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

Death-Related Reports

2,371

Hospitalization Reports

3,830

Top Indication

Prostate Cancer

Gender Distribution

Female 4,348 (45%)
Male 5,342 (55%)

Age Distribution

0–17 49
18–44 1,828
45–64 2,100
65–74 1,392
75+ 1,780

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
11 OFF LABEL USE 457
12 DYSPNOEA 430
13 METASTASES TO LIVER 424
14 ARTHRALGIA 411
15 HEADACHE 385

Reactions in Death Reports

DEATH 1,563
MALIGNANT NEOPLASM PROGRESSION 147
METASTASES TO BONE 78
FATIGUE 75
ASTHENIA 71
DYSPNOEA 68
GENERAL PHYSICAL HEALTH DETERIORATION 66
PROSTATE CANCER 65
ANAEMIA 64
DISEASE PROGRESSION 60

Reactions in Hospitalization Reports

FATIGUE 218
PNEUMONIA 200
DYSPNOEA 196
NAUSEA 190
ANAEMIA 179
PYREXIA 177
ASTHENIA 176
MALIGNANT NEOPLASM PROGRESSION 176
DIARRHOEA 173
VOMITING 164

Source: FDA FAERS (Adverse Event Reporting System) 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?
Zoladex is not a cure for cancer, but it can help slow its growth or ease symptoms.
Will Zoladex stop my periods?
Yes, Zoladex usually stops menstruation, but it is not a reliable form of birth control.
Can I take other medicines with Zoladex?
Tell your doctor about all medicines you take, including over-the-counter drugs and supplements.
How long will I be on Zoladex?
The length of treatment depends on your condition. For endometriosis, it is usually 6 months. For cancer, it may be longer.
What if I have kidney problems?
No dose change is needed if you have kidney problems.
Can Zoladex affect my bones?
Yes, Zoladex can cause bone loss, especially with long-term use. Your doctor may monitor your bone density.
Will I gain weight on Zoladex?
Weight gain is not a common side effect of Zoladex, but it can happen.
Can Zoladex cause mood changes?
Yes, mood changes, including depression, are possible. Tell your doctor if you notice any changes in your mood.
What if I have an allergic reaction to Zoladex?
Stop taking Zoladex and get medical help right away if you have signs of an allergic reaction, such as rash, itching, swelling, or trouble breathing.
Can men continue to have sex while on Zoladex?
Zoladex can cause sexual side effects, such as decreased libido and erectile dysfunction. Talk to your doctor about ways to manage these side effects.
What are the common side effects of goserelin?
The most commonly reported side effects of goserelin include Hot flashes, Sexual problems, Less firm erections, Lower urinary tract symptoms, Headache. Based on 7,451 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
What drug class is goserelin?
goserelin belongs to the GnRH Agonist drug class. It requires a prescription (Rx). Zoladex, along with flutamide, can treat prostate cancer that has not spread far.
Is goserelin safe during pregnancy?
You should not take Zoladex if you are pregnant, unless it is for breast cancer treatment. Zoladex can harm your unborn baby, so use birth control while taking it and for 12 weeks after stopping. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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Related Health & Safety Data

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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 7,451 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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

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. Always consult a healthcare professional before making medication decisions.

Last updated: September 24, 2025

All federal data sources used on this page