Drug · FAERS side-effect profile with label screen
Degarelix side effects: what 5,247 FDA adverse event reports show
Drug class
Gnrh receptor antagonist
FDA label, Indications wording
Brand names
Firmagon
openFDA label
Who reports
5,247 reports · 66% serious · 624 with death outcome · 1% female
openFDA FAERS counts, all years, deduplication not applied
Used for
FIRMAGON ® is indicated for treatment of patients with advanced prostate cancer. FIRMAGON is a GnRH receptor antagonist indicated for treatment of patients with advanced prostate cancer. ( 1 )
FDA label, Indications and Usage
What it is
FIRMAGON is a sterile lyophilized powder for injection containing degarelix (as the acetate) and mannitol. Degarelix is a synthetic linear decapeptide amide containing seven unnatural amino acids, five of which are D-amino acids.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 4Labeled (related wording) 9Likely indication confounding 1Reporting / coding artifact 5Lab value / disease marker 3Not in label — unassessed 18
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 174 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Prostatic specific antigen increased | 165 | 48.2 41.4–56.0ROR 49.7 · χ² 7,487 / p <1e-300 | 47.4 EB05 41.6 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious PRR 46.9 | no trial data cached |
| Injection site induration | 93 | 28.9 23.6–35.3ROR 29.4 · χ² 2,458 / p <1e-300 | 28.5 EB05 24.0 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=40 | no trial data cached |
| Injection site nodule | 53 | 19.4 14.8–25.3ROR 19.6 · χ² 901 / p 3e-198 | 19.2 EB05 15.2 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=21 | no trial data cached |
| Hot flush (hot flashes) | 327 | 17.4 15.7–19.3ROR 18.5 · χ² 5,037 / p <1e-300 | 17.3 EB05 15.8 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.7 | no trial data cached |
| Metastases to bone | 68 | 16.7 13.2–21.1ROR 16.9 · χ² 983 / p 4e-216 | 16.5 EB05 13.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 | no trial data cached |
| Injection site mass | 130 | 14.1 11.9–16.8ROR 14.5 · χ² 1,571 / p <1e-300 | 14.0 EB05 12.1 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 20.2 | no trial data cached |
| Injection site discomfort | 31 | 12.0 8.5–17.1ROR 12.1 · χ² 302 / p 6e-68 | 11.5 EB05 8.2 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=9 | no trial data cached |
| Injection site swelling | 210 | 11.1 9.7–12.7ROR 11.5 · χ² 1,922 / p <1e-300 | 11.0 EB05 9.8 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.7 | no trial data cached |
| Urosepsis | 24 | 10.4 7.0–15.6ROR 10.5 · χ² 195 / p 1e-44 | 9.6 EB05 6.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Injection site warmth | 50 | 9.7 7.4–12.8ROR 9.8 · χ² 382 / p 2e-85 | 9.3 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | no trial data cached |
| Product storage error | 209 | 9.7 8.5–11.0ROR 10.0 · χ² 1,619 / p <1e-300 | 9.6 EB05 8.5 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | 94% clinician | no trial data cached |
| Injection site erythema (redness where injected) | 291 | 9.4 8.4–10.6ROR 9.9 · χ² 2,195 / p <1e-300 | 9.4 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.6 | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 52 | 8.4 6.4–11.0ROR 8.4 · χ² 329 / p 8e-74 | 7.9 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Incorrect route of product administration | 35 | 8.3 6.0–11.6ROR 8.4 · χ² 218 / p 1e-49 | 7.7 EB05 5.7 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 | no trial data cached |
| Hypocalcaemia (low calcium) | 38 | 8.1 5.9–11.1ROR 8.1 · χ² 228 / p 1e-51 | 7.5 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 92% clinician | no trial data cached |
| Product administered at inappropriate site | 33 | 7.3 5.2–10.2ROR 7.3 · χ² 172 / p 1e-39 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=9 | no trial data cached |
| Nocturia (night-time urination) | 19 | 6.3 4.0–9.8ROR 6.3 · χ² 79 / p 3e-19 | 5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Syringe issue | 26 | 5.9 4.0–8.7ROR 6.0 · χ² 102 / p 3e-24 | 5.4 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Bladder disorder | 14 | 5.6 3.3–9.5ROR 5.6 · χ² 49 / p 1e-12 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Disease progression | 162 | 5.5 4.7–6.4ROR 5.6 · χ² 594 / p 2e-131 | 5.4 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · 72% consumer | no trial data cached |
| Metastases to liver | 24 | 5.5 3.7–8.2ROR 5.5 · χ² 83 / p 3e-20 | 5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Interstitial lung disease | 66 | 5.5 4.3–6.9ROR 5.5 · χ² 237 / p 1e-53 | 5.3 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 97% clinician | no trial data cached |
| Ischaemic stroke | 24 | 5.4 3.6–8.0ROR 5.4 · χ² 81 / p 1e-19 | 4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 100% clinician | no trial data cached |
| Injection site reaction | 90 | 5.2 4.3–6.4ROR 5.3 · χ² 306 / p 9e-69 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| Prostate cancer | 106 | 5.2 4.3–6.3ROR 5.3 · χ² 358 / p 3e-80 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.4 | no trial data cached |
| Injection site pain (pain where injected) | 364 | 4.8 4.3–5.3ROR 5.1 · χ² 1,105 / p 1e-242 | 4.8 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.5 | no trial data cached |
| Retinal detachment | 11 | 4.8 2.7–8.6ROR 4.8 · χ² 29 / p 3e-8 | 4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Urinary retention | 39 | 4.7 3.4–6.4ROR 4.7 · χ² 109 / p 6e-26 | 4.5 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Intercepted product preparation error | 14 | 4.6 2.7–7.8ROR 4.6 · χ² 36 / p 1e-9 | 4.0 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Muscle atrophy | 14 | 4.5 2.6–7.5ROR 4.5 · χ² 34 / p 3e-9 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
| Polyneuropathy | 13 | 4.4 2.5–7.5ROR 4.4 · χ² 30 / p 2e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Bone pain | 64 | 4.4 3.4–5.6ROR 4.4 · χ² 163 / p 1e-37 | 4.2 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.3 | no trial data cached |
| Personality change | 10 | 4.3 2.3–7.9ROR 4.3 · χ² 22 / p 1e-6 | 3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Restless legs syndrome | 19 | 4.2 2.7–6.5ROR 4.2 · χ² 43 / p 3e-11 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Product preparation error | 21 | 4.1 2.6–6.2ROR 4.1 · χ² 45 / p 8e-12 | 3.8 EB05 2.6 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious n=4 | no trial data cached |
| Chills | 119 | 4.1 3.4–4.8ROR 4.1 · χ² 272 / p 2e-61 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Erectile dysfunction | 26 | 4.0 2.8–5.9ROR 4.1 · χ² 56 / p 3e-14 | 3.8 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Body temperature decreased | 10 | 4.0 2.2–7.5ROR 4.0 · χ² 20 / p 4e-6 | 3.5 EB05 2.1 · IC025 +0.7 3/3 methods agree | Lab value / disease marker | serious PRR 3.9 | no trial data cached |
| Blood urine present | 19 | 4.0 2.5–6.2ROR 4.0 · χ² 40 / p 2e-10 | 3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious PRR 4.7 | no trial data cached |
| Toxic skin eruption | 10 | 4.0 2.1–7.4ROR 4.0 · χ² 19 / p 6e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 405 | 2.1 1.9–2.3ROR 2.2 · χ² 236 / p 2e-53 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Injection site pain (pain where injected) | 364 | 4.8 4.3–5.3ROR 5.1 · χ² 1,105 / p 1e-242 | 4.8 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.5 | no trial data cached |
| Hot flush (hot flashes) | 327 | 17.4 15.7–19.3ROR 18.5 · χ² 5,037 / p <1e-300 | 17.3 EB05 15.8 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.7 | no trial data cached |
| Injection site erythema (redness where injected) | 291 | 9.4 8.4–10.6ROR 9.9 · χ² 2,195 / p <1e-300 | 9.4 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.6 | no trial data cached |
| Asthenia (weakness) | 222 | 2.4 2.1–2.7ROR 2.4 · χ² 176 / p 2e-40 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Injection site swelling | 210 | 11.1 9.7–12.7ROR 11.5 · χ² 1,922 / p <1e-300 | 11.0 EB05 9.8 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.7 | no trial data cached |
| Product storage error | 209 | 9.7 8.5–11.0ROR 10.0 · χ² 1,619 / p <1e-300 | 9.6 EB05 8.5 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | 94% clinician | no trial data cached |
| Prostatic specific antigen increased | 165 | 48.2 41.4–56.0ROR 49.7 · χ² 7,487 / p <1e-300 | 47.4 EB05 41.6 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious PRR 46.9 | no trial data cached |
| Disease progression | 162 | 5.5 4.7–6.4ROR 5.6 · χ² 594 / p 2e-131 | 5.4 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · 72% consumer | no trial data cached |
| Fall | 161 | 1.9 1.7–2.3ROR 2.0 · χ² 73 / p 6e-18 | 1.9 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Injection site mass | 130 | 14.1 11.9–16.8ROR 14.5 · χ² 1,571 / p <1e-300 | 14.0 EB05 12.1 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 20.2 | no trial data cached |
| Back pain | 127 | 2.2 1.8–2.6ROR 2.2 · χ² 81 / p 1e-19 | 2.2 EB05 1.9 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Chills | 119 | 4.1 3.4–4.8ROR 4.1 · χ² 272 / p 2e-61 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Prostate cancer | 106 | 5.2 4.3–6.3ROR 5.3 · χ² 358 / p 3e-80 | 5.1 EB05 4.3 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.4 | no trial data cached |
| Malignant neoplasm progression | 97 | 3.8 3.1–4.6ROR 3.9 · χ² 199 / p 2e-45 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Metastases to bone — n=68, PRR 16.7
- Urosepsis — n=24, PRR 10.4
- Osteonecrosis of jaw — n=52, PRR 8.4
- Hypocalcaemia — n=38, PRR 8.1
- Syringe issue — n=26, PRR 5.9
- Metastases to liver — n=24, PRR 5.5
- Interstitial lung disease — n=66, PRR 5.5
- Ischaemic stroke — n=24, PRR 5.4
- Urinary retention — n=39, PRR 4.7
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Degarelix?
In FDA FAERS, the most frequently co-reported reaction terms for Degarelix are fatigue, injection site pain, hot flush, injection site erythema, asthenia, injection site swelling. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Degarelix have an FDA boxed warning?
No. The FDA label retrieved for Degarelix has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Degarelix causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID ab11dd8a-0fd9-4013-89ab-e114557c7e4b, effective 20240130; matched on
openfda.generic_name.exact:"DEGARELIX") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 214 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.