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.
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
- Fatigue
Fatigue
377 reports
- Injection Site Pain
Injection Site Pain
350 reports
- Hot Flush
Hot Flush
311 reports
- Injection Site Erythema
Injection Site Erythema
287 reports
- Asthenia
Asthenia
210 reports
- Injection Site Swelling
Injection Site Swelling
205 reports
- Death
Death
195 reports
- Product Storage Error
Product Storage Error
177 reports
- Prostatic Specific Antigen Increased
Prostatic Specific Antigen Increased
164 reports
- Pyrexia
Pyrexia
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) 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?
What pregnancy or breastfeeding source fields are listed for degarelix?
Related Medications in GnRH Antagonist
Other drugs grouped near degarelix - 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 degarelix →
anastrozole
Arimidex
Anastrozole is a medicine used to treat breast cancer in women after menopause.
Compare with degarelix →
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 degarelix →
cabergoline
Dostinex
Cabergoline is a medicine that helps lower the amount of prolactin in your body.
Compare with degarelix →
clomiphene
Clomid, Serophene
Clomiphene citrate is a medicine that helps women ovulate.
Compare with degarelix →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for degarelix: 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: 4,979.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 11.57%.
- indomethacin Δ 0.00 pts · 12,919 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 11.57%death share
- rabeprazole Δ 0.01 pts · 21,352 reports · Proton Pump Inhibitor (PPI) 11.58%death share
- prazosin Δ 0.04 pts · 5,825 reports · Alpha-1 Blocker 11.61%death share
- tafluprost Δ 0.11 pts · 2,845 reports · Prostaglandin Analog (Ophthalmic) 11.46%death share
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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 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: January 30, 2024
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