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degarelix Side Effects

Also known as: Firmagon

Analysis of 4,979 adverse event reports submitted to the FDA from 2007 to 2025.

Total Reports

4,979

Death-Related

576

11.6% of reports

Hospitalizations

1,629

32.7% of reports

Top Indication

Prostate Cancer

Most Reported Adverse Reactions

FATIGUE
377
INJECTION SITE PAIN
350
HOT FLUSH
311
INJECTION SITE ERYTHEMA
287
ASTHENIA
210
INJECTION SITE SWELLING
205
DEATH
195
PRODUCT STORAGE ERROR
177
PROSTATIC SPECIFIC ANTIGEN INCREASED
164
PYREXIA
164
FALL
157
DIZZINESS
144
PAIN
144
NAUSEA
142
OFF LABEL USE
142
DISEASE PROGRESSION
137
ARTHRALGIA
129
DYSPNOEA
127
INJECTION SITE MASS
124
BACK PAIN
121

Who Reports Side Effects

Gender Distribution

Female 26 (1%)
Male 3,558 (99%)
Unknown 4

Age Distribution

0-17 27 (1%)
18-44 13 (1%)
45-64 418 (16%)
65-74 934 (36%)
75+ 1,199 (46%)

Reporting Trend by Year

2007 2025

Reactions in Death Reports

Top reactions reported in 576 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 190
DISEASE PROGRESSION 97
PROSTATE CANCER 39
MALIGNANT NEOPLASM PROGRESSION 33
PROSTATE CANCER METASTATIC 28
ASTHENIA 23
FATIGUE 21
GENERAL PHYSICAL HEALTH DETERIORATION 19
PNEUMONIA 19
MYOCARDIAL INFARCTION 17
CARDIAC ARREST 16
DYSPNOEA 16
FALL 16
PAIN 15
ANAEMIA 14
DECREASED APPETITE 14
PROSTATIC SPECIFIC ANTIGEN INCREASED 14
OFF LABEL USE 13
PYREXIA 12
CEREBROVASCULAR ACCIDENT 11

Reactions in Hospitalization Reports

Top reactions in 1,629 reports where hospitalization was an outcome.

Reaction Reports
FATIGUE 109
FALL 98
PYREXIA 93
ASTHENIA 69
ANAEMIA 62
ACUTE KIDNEY INJURY 57
DYSPNOEA 57
INJECTION SITE PAIN 56
CEREBROVASCULAR ACCIDENT 55
DEHYDRATION 55
MALAISE 55
ABDOMINAL PAIN 54
PAIN 54
URINARY TRACT INFECTION 53
DEATH 49
DIZZINESS 49
DIARRHOEA 48
DECREASED APPETITE 47
INJECTION SITE ERYTHEMA 47
GENERAL PHYSICAL HEALTH DETERIORATION 44

Nearby — Related Medications

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What the FAERS Data Reveals About degarelix Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 4,979 voluntary reports linked to degarelix and its brand equivalents (Firmagon), spanning 2007 through 2025. Of those, 576 (11.6%) listed death as an outcome and 1,629 (32.7%) involved hospitalization. The most common indication reported alongside adverse events was Prostate Cancer.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 1% were female and 99% male; age distribution skews toward 75+, with 1,199 reports in that bracket. The single most reported reaction is fatigue with 377 submissions, followed by injection site pain and hot flush.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.