Prescription medication · GnRH Antagonist
degarelix
Also sold as Firmagon. Firmagon is used to treat advanced prostate cancer in men.
Data updated 2026-05-15
- 4,979
- FDA reportsLightly reported
- Rx
- Availability
degarelix (Firmagon) is a prescription GnRH Antagonist. Firmagon is used to treat advanced prostate cancer in men.
Firmagon is a medicine used to treat advanced prostate cancer. It works by lowering the amount of testosterone in the body.
Verify with FDA → · CMS NADAC pricing →
What it does
Firmagon is used to treat advanced prostate cancer in men.
Common side effects
Injection site reactions (pain, redness, swelling), Hot flashes, Increased liver enzyme levels
Key warnings
Firmagon can cause harm to an unborn baby.
The sections below are summarized in plain English from degarelix's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Firmagon is a GnRH receptor antagonist. This means it blocks the effects of a hormone called gonadotropin-releasing hormone (GnRH). By blocking GnRH, Firmagon lowers the amount of testosterone produced by the body.
How to Take It
Firmagon is given as a shot under the skin (subcutaneous injection) in the stomach area by a healthcare provider. The starting dose is 240 mg, given as two shots of 120 mg each. After that, you will receive 80 mg as one shot every 28 days.
This is a plain-language summary of degarelix's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Firmagon is not for use in women. It can cause harm to an unborn baby if a pregnant woman takes it. It is not known if Firmagon passes into breast milk.
This is a plain-language summary of degarelix's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, contact your doctor right away to reschedule your injection. Do not try to give yourself a double dose.
This is a plain-language summary of degarelix's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store Firmagon at room temperature, between 68°F to 77°F.
Side Effects (from patient reports)
Based on 4,979 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for degarelix, by number of reports
- Tiredness
Tiredness
377 reports
- Pain at the injection site
Pain at the injection site
350 reports
- Hot flash
Hot flash
311 reports
- Redness at the injection site
Redness at the injection site
287 reports
- Weakness
Weakness
210 reports
- Swelling at the injection site
Swelling at the injection site
205 reports
- Death
Death
195 reports
- Problem storing the medicine
Problem storing the medicine
177 reports
- Increased PSA levels
Increased PSA levels
164 reports
- Fever
Fever
164 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 degarelix 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 degarelix sits
degarelix has more FDA adverse-event reports than 25% 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 degarelix; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 4,979 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2007–2025.
Total Reports
4,979
Reports Mentioning Death
576
11.6% of reports — not proof of cause
Hospitalization Reports
1,629
Top Indication
Prostate Cancer
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 377 |
| 2 | INJECTION SITE PAIN | 350 |
| 3 | HOT FLUSH | 311 |
| 4 | INJECTION SITE ERYTHEMA | 287 |
| 5 | ASTHENIA | 210 |
| 6 | INJECTION SITE SWELLING | 205 |
| 7 | DEATH | 195 |
| 8 | PRODUCT STORAGE ERROR | 177 |
| 9 | PROSTATIC SPECIFIC ANTIGEN INCREASED | 164 |
| 10 | PYREXIA | 164 |
| 11 | FALL | 157 |
| 12 | DIZZINESS | 144 |
| 13 | PAIN | 144 |
| 14 | NAUSEA | 142 |
| 16 | DISEASE PROGRESSION | 137 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Firmagon can cause harm to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Androgen deprivation therapy with Firmagon may prolong the QT interval. Your doctor should consider the benefits versus the risks if you have certain heart conditions or electrolyte abnormalities.
Common Questions
How is Firmagon given?
How often will I receive Firmagon?
What are the most common side effects?
Can Firmagon affect my heart?
What should I do if I have a severe allergic reaction?
Can Firmagon affect my fertility?
Is Firmagon safe for people with liver or kidney problems?
Will Firmagon interact with other medications I am taking?
How will my doctor monitor my treatment with Firmagon?
What does Firmagon look like?
What are the common side effects of degarelix?
What drug class is degarelix?
Is degarelix safe during pregnancy?
Related Medications in GnRH Antagonist
Other drugs grouped near degarelix - same-class peers and common alternatives.
abiraterone
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anastrozole
Arimidex
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bazedoxifene/conjugated estrogens
Duavee
Duavee is a combination medicine containing estrogen and a drug that blocks estrogen in some parts of the body.
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cabergoline
Dostinex
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clomiphene
Clomid, Serophene
Clomiphene citrate is a medicine that helps women ovulate.
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What the FDA Data Shows for degarelix
The FDA label for degarelix (sold under brand names such as Firmagon) classifies it as a prescription-only medication in the GnRH Antagonist class. Firmagon is used to treat advanced prostate cancer in men. Official labeling lists 3 commonly reported side effects, including Injection site reactions (pain, redness, swelling), Hot flashes, Increased liver enzyme levels.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 4,979 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: January 30, 2024
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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