TRIAL RESULTS · SIDE EFFECTS
Degarelix side effects
ANSWER
In 2 placebo-controlled trials with posted results, the most common side effects of Degarelix were injection site erythema 14.1% (placebo 0.0%), injection site pain 8.4% (placebo 0.0%), injection site induration 7.8% (placebo 0.0%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
29
with an arm on Degarelix, of 187 registered
Against placebo
2
placebo-controlled trials
People in those trials
368
on Degarelix · 132 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Degarelix beside placebo
Share of people with each side effect in 2 placebo-controlled trials with posted results: 368 people on Degarelix (all doses), 132 on placebo, same trials. Listed only when reported for at least half of the people on Degarelix. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
The 100 most reported of 829 side effects reported
Every trial with posted results and an arm on Degarelix (n ≥ 20), all phases, by people affected. Placebo is shown where placebo-controlled trials reported the same event. Comparator arms are not counted.
| Side effect | Organ system | Degarelix | Placebo | Trials |
|---|---|---|---|---|
| Hot flush | Vascular disorders | 26.7% (1,340 of 5,014) | 0.8% | 20 |
| Injection site pain | General disorders | 23.1% (1,185 of 5,132) | 0.0% | 20 |
| Injection site erythema | General disorders | 18.2% (737 of 4,056) | 0.0% | 18 |
| Fatigue | General disorders | 7.6% (379 of 4,982) | 0.0% | 19 |
| Hypertension | Vascular disorders | 4.9% (249 of 5,056) | 7.1% | 18 |
| Pyrexia | General disorders | 4.2% (246 of 5,794) | 0.0% | 15 |
| Injection site swelling | General disorders | 7.6% (239 of 3,158) | - | 11 |
| Back pain | Musculoskeletal and connective tissue disorders | 4.8% (221 of 4,645) | 9.2% | 15 |
| Weight increased | Investigations | 8.3% (210 of 2,532) | - | 8 |
| Hot Flush | Vascular disorders | 39.9% (197 of 494) | - | 2 |
| Injection site nodule | General disorders | 8.2% (190 of 2,315) | - | 6 |
| Urinary tract infection | Infections and infestations | 4.2% (189 of 4,483) | 2.9% | 16 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 8.5% (187 of 2,210) | - | 11 |
| Constipation | Gastrointestinal disorders | 5.1% (184 of 3,588) | 0.0% | 16 |
| Prostatic specific antigen increased | Investigations | 6.6% (182 of 2,769) | 6.1% | 7 |
| Dizziness | Nervous system disorders | 3.5% (173 of 5,005) | - | 15 |
| Diarrhoea | Gastrointestinal disorders | 5.1% (157 of 3,087) | 0.0% | 11 |
| Injection Site Pain | General disorders | 27.7% (137 of 494) | - | 2 |
| Nausea | Gastrointestinal disorders | 4.8% (128 of 2,654) | 0.0% | 10 |
| Nasopharyngitis | Infections and infestations | 6.3% (128 of 2,023) | 5.1% | 8 |
| Injection site induration | General disorders | 5.7% (126 of 2,229) | 0.0% | 10 |
| Anaemia | Blood and lymphatic system disorders | 2.2% (118 of 5,426) | - | 14 |
| Headache | Nervous system disorders | 2.3% (113 of 4,812) | 5.1% | 15 |
| Asthenia | General disorders | 2.0% (108 of 5,405) | - | 14 |
| Insomnia | Psychiatric disorders | 5.0% (107 of 2,151) | - | 11 |
| Weight decreased | Investigations | 3.1% (106 of 3,436) | - | 8 |
| Injection Site Erythema | General disorders | 19.8% (98 of 494) | - | 2 |
| Influenza | Infections and infestations | 5.5% (94 of 1,711) | 5.1% | 8 |
| Dysuria | Renal and urinary disorders | 3.4% (92 of 2,698) | - | 10 |
| Pollakiuria | Renal and urinary disorders | 3.4% (84 of 2,507) | - | 9 |
| Urinary retention | Renal and urinary disorders | 1.8% (83 of 4,656) | - | 16 |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2.4% (83 of 3,419) | 0.0% | 9 |
| Alanine aminotransferase increased | Investigations | 6.0% (83 of 1,391) | - | 5 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 2.3% (81 of 3,497) | 0.0% | 9 |
| Haematuria | Renal and urinary disorders | 1.7% (77 of 4,621) | - | 13 |
| Cough | Respiratory, thoracic and mediastinal disorders | 3.4% (71 of 2,070) | 5.1% | 9 |
| Oedema peripheral | General disorders | 2.0% (69 of 3,409) | - | 9 |
| Injection Site Swelling | General disorders | 13.4% (66 of 494) | - | 2 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 1.6% (62 of 3,779) | 2.9% | 9 |
| Upper respiratory tract infection | Infections and infestations | 4.8% (61 of 1,275) | - | 6 |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | 3.0% (60 of 1,978) | - | 8 |
| Nocturia | Renal and urinary disorders | 2.5% (59 of 2,363) | - | 8 |
| Weight Increased | Investigations | 11.3% (56 of 494) | - | 2 |
| Erectile dysfunction | Reproductive system and breast disorders | 4.4% (48 of 1,103) | 0.0% | 7 |
| Aspartate aminotransferase increased | Investigations | 5.5% (47 of 862) | - | 3 |
| Chills | General disorders | 2.2% (46 of 2,132) | - | 4 |
| Injection Site Induration | General disorders | 9.3% (46 of 494) | - | 2 |
| Death (unknown cause) | General disorders | 3.2% (46 of 1,454) | - | 1 |
| Bronchitis | Infections and infestations | 4.6% (45 of 988) | - | 5 |
| Gamma-glutamyltransferase increased | Investigations | 4.8% (44 of 919) | - | 4 |
| Hypercholesterolaemia | Metabolism and nutrition disorders | 6.3% (43 of 681) | - | 2 |
| Vomiting | Gastrointestinal disorders | 1.1% (38 of 3,358) | - | 6 |
| Blood creatinine increased | Investigations | 2.2% (38 of 1,738) | - | 4 |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1.6% (37 of 2,288) | - | 6 |
| Atrial fibrillation | Cardiac disorders | 0.8% (35 of 4,308) | 5.9% | 13 |
| Myalgia | Musculoskeletal and connective tissue disorders | 3.8% (35 of 929) | - | 5 |
| Injection site inflammation | General disorders | 4.2% (35 of 842) | - | 4 |
| Back Pain | Musculoskeletal and connective tissue disorders | 7.1% (35 of 494) | - | 2 |
| Pneumonia | Infections and infestations | 0.8% (34 of 4,503) | - | 13 |
| Blood alkaline phosphatase increased | Investigations | 1.7% (34 of 1,946) | - | 5 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 1.2% (33 of 2,650) | 2.9% | 8 |
| Cataract | Eye disorders | 1.3% (33 of 2,640) | - | 7 |
| Depression | Psychiatric disorders | 1.6% (33 of 2,012) | 0.0% | 5 |
| Alopecia | Skin and subcutaneous tissue disorders | 17.6% (33 of 188) | - | 2 |
| Disease progression | General disorders | 1.4% (32 of 2,271) | - | 6 |
| Myocardial infarction | Cardiac disorders | 0.8% (31 of 3,673) | - | 9 |
| Dyspepsia | Gastrointestinal disorders | 1.4% (31 of 2,243) | - | 7 |
| Hot flashes | Vascular disorders | 56.9% (29 of 51) | - | 1 |
| Hydronephrosis | Renal and urinary disorders | 1.2% (28 of 2,406) | - | 5 |
| Blood urea increased | Investigations | 1.7% (28 of 1,681) | - | 3 |
| Oedema Peripheral | General disorders | 5.5% (27 of 494) | - | 2 |
| Fall | Injury, poisoning and procedural complications | 1.0% (25 of 2,405) | - | 6 |
| Rash | Skin and subcutaneous tissue disorders | 4.7% (25 of 534) | 0.0% | 4 |
| Decreased appetite | Metabolism and nutrition disorders | 0.8% (24 of 3,055) | - | 4 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 2.6% (24 of 906) | - | 3 |
| Urinary Tract Infection | General disorders | 4.5% (22 of 494) | - | 2 |
| Atrial Fibrillation | Cardiac disorders | 7.9% (22 of 278) | - | 1 |
| Injection site reaction | General disorders | 6.8% (21 of 307) | 0.0% | 4 |
| Hot Flashes/Flushes | Vascular disorders | 80.0% (20 of 25) | - | 1 |
| Injection Site Pruritus | General disorders | 3.8% (19 of 494) | - | 2 |
| Acute myocardial infarction | Cardiac disorders | 0.4% (18 of 4,146) | - | 10 |
| Cerebrovascular accident | Nervous system disorders | 0.4% (18 of 4,205) | 0.0% | 9 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 0.5% (18 of 3,635) | 0.0% | 9 |
| Abdominal pain | Gastrointestinal disorders | 0.9% (18 of 2,032) | 0.0% | 7 |
| Chest pain | General disorders | 0.8% (18 of 2,205) | - | 5 |
| Syncope | Nervous system disorders | 0.4% (17 of 3,975) | 2.9% | 11 |
| Myocardial ischaemia | Cardiac disorders | 1.0% (17 of 1,775) | - | 7 |
| Death | General disorders | 0.6% (17 of 3,082) | - | 6 |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.7% (17 of 2,303) | - | 5 |
| Vertigo | Ear and labyrinth disorders | 0.9% (17 of 1,954) | - | 5 |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 1.3% (17 of 1,271) | - | 4 |
| Abdominal Pain | Gastrointestinal disorders | 6.1% (17 of 278) | - | 1 |
| Edema limbs | General disorders | 33.3% (17 of 51) | - | 1 |
| Injection site reactions | General disorders | 1.2% (17 of 1,454) | - | 1 |
| Inguinal hernia | Gastrointestinal disorders | 0.4% (16 of 4,313) | - | 12 |
| Alanine Aminotransferase Increased | Investigations | 5.8% (16 of 278) | - | 1 |
| Dysgeusia | Nervous system disorders | 31.4% (16 of 51) | - | 1 |
| Nail discoloration | Skin and subcutaneous tissue disorders | 31.4% (16 of 51) | - | 1 |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 0.3% (15 of 4,399) | 0.0% | 11 |
| Renal failure | Renal and urinary disorders | 0.5% (15 of 3,232) | 0.0% | 9 |
Source: ClinicalTrials.gov posted results, read 2026-10-03. A trial lists events above its own reporting threshold, so a rare event may be missing from some trials. Not medical advice.
QUESTIONS
Does degarelix cause injection site erythema?
In 2 placebo-controlled trials with posted results, 14.1% of people on degarelix reported injection site erythema, against 0.0% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does degarelix cause injection site pain?
In 2 placebo-controlled trials with posted results, 8.4% of people on degarelix reported injection site pain, against 0.0% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does degarelix cause injection site induration?
In 2 placebo-controlled trials with posted results, 7.8% of people on degarelix reported injection site induration, against 0.0% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does degarelix cause hypertension?
In 2 placebo-controlled trials with posted results, 6.2% of people on degarelix reported hypertension, against 7.1% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does degarelix cause back pain?
In 2 placebo-controlled trials with posted results, 4.9% of people on degarelix reported back pain, against 9.2% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
187 registered clinical trials of Degarelix
The 10 most recently updated are listed.
| NCT01630967 | Efficacy Study of Switching to a Lutenizing Hormone-releasing Hormone (LHRH) Antagonist From a LHRH Agonist to Treat Progressive Castrate Resistant Prostate Cancer (CRPC) Status: WITHDRAWN · Updated 2026-10-01 |
|---|---|
| NCT04989946 | Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer Status: ACTIVE_NOT_RECRUITING · Updated 2026-09-30 |
| NCT03070886 | Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery Status: ACTIVE_NOT_RECRUITING · Updated 2026-09-14 |
| NCT07335796 | A Study of BMS986365 in Combination With Degarelix in People With Prostate Cancer Status: ACTIVE_NOT_RECRUITING · Updated 2026-09-11 |
| 2023-509494-23-00 | DARIUS : A RANDOMIZED NON-COMPARATIVE PHASE II MULTICENTRIC TRIAL ON SHORT TERM DAROLUTAMIDE (ODM-201) CONCOMITANT TO RADIATION THERAPY FOR PATIENTS WITH INTERMEDIATE UNFAVORABLE RISK PROSTATE CANCER Status: UNKNOWN · Updated 2026-09-07 |
| 2025-521859-23-00 | A phase Ib/II open-label, multi-center study of the DNA protein kinase inhibitor AMO959 with lutetium (177Lu) vipivotide tetraxetan (AAA617) in combination with an androgen receptor pathway inhibitor (ARPI) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) Status: UNKNOWN · Updated 2026-09-03 |
| NCT02005887 | TRial on the Endocrine Activity of Neoadjuvant Degarelix Status: COMPLETED · Updated 2026-09-02 |
| NCT04633252 | A Phase I/II Study of PDS01ADC With Docetaxel and Abiraterone in Adults With Metastatic Castration Sensitive and PDS01ADC With Docetaxel in Castration Resistant Prostate Cancer Status: RECRUITING · Updated 2026-08-28 |
| 2022-503040-41-00 | An international prospective open-label, multi-center, randomized, non-comparative phase II study of lutetium [177Lu] vipivotide tetraxetan (AAA617) alone and lutetium [177Lu] vipivotide tetraxetan (AAA617) in combination with androgen receptor pathway inhibitors in patients with PSMA PET scan positive castration-resistant prostate cancer (PSMACare) Status: UNKNOWN · Updated 2026-08-26 |
| NCT05501704 | ETHAN - ET for Male BC Status: RECRUITING · Updated 2026-08-24 |
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