What the label lists and what reports show
Degarelix side effects
Degarelix's FDA label: “Most common adverse reactions (≥10%) are injection site reactions (e.g., pain, erythema, swelling or induration), hot flashes, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS …” FAERS holds 5,247 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (405 reports).
- No generic listed
Check it at the source: the degarelix FDA label on DailyMed (effective January 30, 2024, Ferring Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of FIRMAGON?FIRMAGON can cause serious side effects, including: Serious allergic reactions. Get medical help right away if you get any of these symptoms: trouble breathing or wheezing severe itching swelling of your face, lips, mouth, or tongue Disorder of the heart's electrical activity. Your healthcare provider may do tests during treatment with FIRMAGON to check your heart for a condition called long QT syndrome. The common side effects of FIRMAGON include: injection site pain, redness, and swelling hot flashes weight gain increase in some liver enzymes Other side effects include decreased sex drive and erectile function problems. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Ferring Pharmaceuticals Inc., effective January 30, 2024 (SPL set ab11dd8a-0fd9-4013-89ab-e114557c7e4b), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥10%) are injection site reactions (e.g., pain, erythema, swelling or induration), hot flashes, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 2: Adverse Reactions Reported in ≥ 5% of Patients
| Reaction | FIRMAGON 240/80 mg (subcutaneous) N = 207 | Leuprolide 7.5 mg (intramuscular) N = 201 |
|---|---|---|
| Any adverse reaction | 79% | 78% |
| Injection site reactions Includes pain, erythema, swelling, induration, or nodule. | 35% | <1% |
| Weight increase | 9% | 12% |
| Chills | 5% | 0% |
| Hot flash | 26% | 21% |
| Hypertension | 6% | 4% |
| Increases in Transaminases and GGT | 10% | 5% |
| Constipation | 5% | 5% |
| Back pain | 6% | 8% |
| Arthralgia | 5% | 9% |
| Urinary tract infection | 5% | 9% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost common adverse reactions (≥10%) are injection site reactions (e.g., pain, erythema, swelling or induration), hot flashes, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. FIRMAGON was studied in a randomized, open-label trial in which patients with prostate cancer were randomized to receive FIRMAGON (subcutaneous) or leuprolide (intramuscular) monthly for 12 months [see Clinical Studies (14) ]. The most common adverse reactions (≥10%) during FIRMAGON therapy are injection site reactions (e.g., pain, erythema, swelling or induration), hot flashes, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). The majority of the adverse reactions were Grade 1 or 2, with Grade 3/4 adverse reaction incidences of 1% or less. …
Source: FDA drug label, Ferring Pharmaceuticals Inc., effective January 30, 2024 (SPL set ab11dd8a-0fd9-4013-89ab-e114557c7e4b), via openFDA; the full label on DailyMed
What do FAERS reports show?
5,247 reports list degarelix among the medicines taken, each a report of something that happened, not proof the medicine caused it; 624 are coded as a death and 1,710 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. Of the 22 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Degarelix: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions