TRIAL RESULTS · SIDE EFFECTS
Leuprolide side effects
ANSWER
In 2 placebo-controlled trials with posted results, the most common side effects of Leuprolide were hot flush 68.8% (placebo 57.3%), fatigue 42.8% (placebo 32.8%), arthralgia 27.5% (placebo 20.9%). Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
30
with an arm on Leuprolide, of 520 registered
Against placebo
2
placebo-controlled trials
People in those trials
512
on Leuprolide · 478 on placebo
Read
2026-10-03
ClinicalTrials.gov
VS PLACEBO
Most common side effects, Leuprolide beside placebo
Share of people with each side effect in 2 placebo-controlled trials with posted results: 512 people on Leuprolide (all doses), 478 on placebo, same trials. Listed only when reported for at least half of the people on Leuprolide. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
ALL TRIALS
The 100 most reported of 1756 side effects reported
Every trial with posted results and an arm on Leuprolide (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 | Leuprolide | Placebo | Trials |
|---|---|---|---|---|
| Hot flush | Vascular disorders | 49.2% (923 of 1,877) | 57.3% | 11 |
| Fatigue | General disorders | 25.0% (502 of 2,004) | 32.8% | 15 |
| hot flush | Vascular disorders | 46.1% (233 of 505) | - | 3 |
| Hypertension | Vascular disorders | 11.0% (229 of 2,090) | 15.1% | 13 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 11.3% (224 of 1,986) | 20.9% | 13 |
| HOT FLUSH | Vascular disorders | 46.8% (200 of 427) | - | 2 |
| Headache | Nervous system disorders | 9.8% (190 of 1,941) | 9.4% | 15 |
| Back pain | Musculoskeletal and connective tissue disorders | 9.2% (173 of 1,872) | 15.3% | 11 |
| FATIGUE | General disorders | 37.9% (162 of 427) | - | 2 |
| Diarrhoea | Gastrointestinal disorders | 9.8% (155 of 1,576) | 8.5% | 8 |
| Constipation | Gastrointestinal disorders | 8.2% (154 of 1,867) | 13.2% | 12 |
| Insomnia | Psychiatric disorders | 9.2% (150 of 1,630) | 10.0% | 12 |
| Nausea | Gastrointestinal disorders | 7.5% (137 of 1,819) | 8.2% | 13 |
| Dizziness | Nervous system disorders | 7.2% (136 of 1,900) | 10.5% | 12 |
| TEAE Related Hot Flushes | Vascular disorders | 77.3% (126 of 163) | - | 1 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 6.5% (125 of 1,926) | 10.2% | 12 |
| ALOPECIA | Skin and subcutaneous tissue disorders | 28.2% (113 of 400) | - | 1 |
| Asthenia | General disorders | 6.8% (107 of 1,565) | 5.9% | 8 |
| Weight increased | Investigations | 8.6% (102 of 1,187) | 8.5% | 7 |
| Hot flashes/flashes | Vascular disorders | 64.2% (102 of 159) | 7.3% | 1 |
| Pollakiuria | Renal and urinary disorders | 8.6% (98 of 1,134) | 8.5% | 6 |
| Urinary tract infection | Infections and infestations | 5.4% (93 of 1,709) | 7.1% | 11 |
| Urinary incontinence | Renal and urinary disorders | 7.6% (90 of 1,187) | 7.9% | 7 |
| Nocturia | Renal and urinary disorders | 6.2% (87 of 1,406) | 4.5% | 8 |
| Nasopharyngitis | Infections and infestations | 7.2% (84 of 1,163) | 6.2% | 7 |
| Hot Flashes | Vascular disorders | 46.2% (84 of 182) | - | 3 |
| Fall | Injury, poisoning and procedural complications | 6.5% (82 of 1,252) | 14.1% | 5 |
| Injection site pain | General disorders | 8.9% (80 of 895) | - | 6 |
| DIARRHOEA | Gastrointestinal disorders | 15.8% (79 of 499) | - | 3 |
| Rash | Skin and subcutaneous tissue disorders | 12.4% (78 of 627) | 6.5% | 4 |
| OEDEMA PERIPHERAL | General disorders | 19.3% (77 of 400) | - | 1 |
| Haematuria | Renal and urinary disorders | 4.7% (76 of 1,609) | 11.6% | 8 |
| Oedema peripheral | General disorders | 7.7% (74 of 961) | 10.2% | 6 |
| NAUSEA | Gastrointestinal disorders | 14.6% (73 of 499) | - | 3 |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | 13.6% (68 of 499) | - | 3 |
| Cough | Respiratory, thoracic and mediastinal disorders | 5.2% (67 of 1,293) | 6.7% | 11 |
| Anaemia | Blood and lymphatic system disorders | 5.6% (67 of 1,198) | 3.1% | 7 |
| Aspartate aminotransferase increased | Investigations | 21.2% (62 of 292) | - | 5 |
| Alanine aminotransferase increased | Investigations | 20.9% (61 of 292) | - | 5 |
| Weight decreased | Investigations | 7.8% (58 of 740) | 3.4% | 5 |
| Alopecia | Skin and subcutaneous tissue disorders | 8.4% (58 of 687) | 1.0% | 4 |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | 11.2% (56 of 499) | - | 3 |
| Depression | Psychiatric disorders | 4.9% (54 of 1,092) | 5.6% | 10 |
| Myalgia | General disorders | 7.3% (54 of 744) | - | 9 |
| injection site pain | General disorders | 17.1% (53 of 310) | - | 1 |
| Dysuria | Renal and urinary disorders | 4.0% (52 of 1,299) | 5.1% | 9 |
| DYSGEUSIA | Nervous system disorders | 13.0% (52 of 400) | - | 1 |
| HEADACHE | Nervous system disorders | 10.2% (51 of 499) | - | 3 |
| NAIL DISORDER | Skin and subcutaneous tissue disorders | 12.8% (51 of 400) | - | 1 |
| Upper respiratory tract infection | Infections and infestations | 4.0% (49 of 1,226) | 7.1% | 7 |
| COUGH | Respiratory, thoracic and mediastinal disorders | 9.8% (49 of 499) | - | 3 |
| Erectile dysfunction | Reproductive system and breast disorders | 12.2% (48 of 393) | - | 5 |
| Pyrexia | General disorders | 3.8% (47 of 1,223) | 0.0% | 8 |
| Neuropathy:Sensory | Nervous system disorders | 48.0% (47 of 98) | - | 1 |
| Mood Alteration | Nervous system disorders | 46.9% (46 of 98) | - | 1 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 5.0% (45 of 902) | 6.5% | 5 |
| Decreased appetite | Metabolism and nutrition disorders | 7.1% (45 of 634) | 4.2% | 4 |
| INJECTION SITE PAIN | General disorders | 45.5% (45 of 99) | - | 2 |
| Diarrhea | Gastrointestinal disorders | 15.3% (42 of 274) | - | 6 |
| Vomiting | Gastrointestinal disorders | 2.9% (41 of 1,399) | 0.6% | 10 |
| CONSTIPATION | Gastrointestinal disorders | 8.2% (41 of 499) | - | 3 |
| INSOMNIA | Psychiatric disorders | 9.6% (41 of 427) | - | 2 |
| fatigue | General disorders | 11.4% (41 of 361) | - | 2 |
| PYREXIA | General disorders | 8.0% (40 of 499) | - | 3 |
| MYALGIA | Musculoskeletal and connective tissue disorders | 9.4% (40 of 427) | - | 2 |
| NEUROPATHY PERIPHERAL | Nervous system disorders | 10.0% (40 of 400) | - | 1 |
| arthralgia | Musculoskeletal and connective tissue disorders | 10.8% (39 of 361) | - | 2 |
| Gynaecomastia | Reproductive system and breast disorders | 6.8% (38 of 557) | 9.0% | 4 |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | 8.9% (38 of 427) | - | 2 |
| COVID-19 | Infections and infestations | 6.3% (36 of 567) | 9.6% | 3 |
| Pain (Joint) | Musculoskeletal and connective tissue disorders | 35.7% (35 of 98) | - | 1 |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | 8.8% (35 of 400) | - | 1 |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | 6.8% (34 of 499) | - | 3 |
| Prostatic specific antigen increased | Investigations | 14.1% (34 of 241) | - | 2 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 2.9% (33 of 1,141) | 0.6% | 7 |
| constipation | Gastrointestinal disorders | 9.1% (33 of 361) | - | 2 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 3.8% (32 of 845) | 5.4% | 5 |
| Libido | Psychiatric disorders | 12.5% (32 of 257) | 0.0% | 2 |
| Injection Site Reaction | Skin and subcutaneous tissue disorders | 32.7% (32 of 98) | - | 1 |
| Urinary retention | Renal and urinary disorders | 2.2% (31 of 1,401) | 0.2% | 8 |
| Abdominal pain | Gastrointestinal disorders | 2.8% (31 of 1,127) | 0.0% | 8 |
| Dry skin | Skin and subcutaneous tissue disorders | 4.6% (31 of 678) | 3.1% | 5 |
| Bronchitis | Infections and infestations | 2.8% (31 of 1,095) | 3.4% | 5 |
| Hyperglycemia | Metabolism and nutrition disorders | 9.4% (31 of 331) | 19.4% | 4 |
| Pharyngitis | Infections and infestations | 17.6% (31 of 176) | - | 2 |
| NEUTROPENIA | Blood and lymphatic system disorders | 7.8% (31 of 400) | - | 1 |
| LACRIMATION INCREASED | Eye disorders | 7.8% (31 of 400) | - | 1 |
| Anemia | Blood and lymphatic system disorders | 7.8% (30 of 384) | - | 3 |
| Dysgeusia | Nervous system disorders | 17.1% (30 of 175) | - | 2 |
| Anxiety | Psychiatric disorders | 4.3% (29 of 682) | 3.1% | 7 |
| Injection site erythema | General disorders | 4.1% (29 of 703) | - | 4 |
| WEIGHT INCREASED | Investigations | 5.8% (29 of 499) | - | 3 |
| Rib fracture | Injury, poisoning and procedural complications | 3.1% (29 of 930) | 6.5% | 3 |
| Memory impairment | Nervous system disorders | 7.7% (29 of 378) | 3.4% | 2 |
| URINARY INCONTINENCE | Renal and urinary disorders | 7.2% (29 of 400) | - | 1 |
| VOMITING | Gastrointestinal disorders | 5.6% (28 of 499) | - | 3 |
| BACK PAIN | Musculoskeletal and connective tissue disorders | 6.6% (28 of 427) | - | 2 |
| dizziness | Nervous system disorders | 7.8% (28 of 361) | - | 2 |
| Sinusitis | Infections and infestations | 5.9% (27 of 457) | - | 6 |
| Gynecomastia | Reproductive system and breast disorders | 9.4% (27 of 287) | 3.2% | 3 |
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.
FDA LABEL
What the FDA label says
Vabrinty NDA021379 · label of 2026-04-30 Regulator
Most common adverse reactions in clinical studies (incidence ≥ 5%): Malaise, fatigue, hot flashes/sweats, and testicular atrophy.
Eligard NDA021379 · label of 2026-04-30 Regulator
Most common adverse reactions in clinical studies (incidence ≥ 5%): Malaise, fatigue, hot flashes/sweats, and testicular atrophy.
Lupron Depot NDA020517 · label of 2026-03-15 Regulator
The most common adverse reactions (>10%) were general pain, hot flashes/sweats, GI disorders, edema, respiratory disorder, urinary disorder.
QUESTIONS
Does leuprolide cause hot flush?
In 2 placebo-controlled trials with posted results, 68.8% of people on leuprolide reported hot flush, against 57.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does leuprolide cause fatigue?
In 2 placebo-controlled trials with posted results, 42.8% of people on leuprolide reported fatigue, against 32.8% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does leuprolide cause arthralgia?
In 2 placebo-controlled trials with posted results, 27.5% of people on leuprolide reported arthralgia, against 20.9% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does leuprolide cause fall?
In 2 placebo-controlled trials with posted results, 20.4% of people on leuprolide reported fall, against 14.1% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
Does leuprolide cause back pain?
In 2 placebo-controlled trials with posted results, 17.0% of people on leuprolide reported back pain, against 15.3% on placebo. Source: ClinicalTrials.gov, read 2026-10-03. Not medical advice.
REGISTERED STUDIES
520 registered clinical trials of Leuprolide
The 10 most recently updated are listed.
| NCT05827081 | Phase IIIb Study of Ribociclib + ET in Early Breast Cancer Status: RECRUITING · Updated 2026-10-02 |
|---|---|
| NCT04906395 | Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer Status: ACTIVE_NOT_RECRUITING · Updated 2026-09-29 |
| NCT03649724 | The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's Status: COMPLETED · Updated 2026-09-21 |
| NCT07650240 | Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial Status: RECRUITING · Updated 2026-09-18 |
| 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 |
| NCT02960022 | A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study Status: ACTIVE_NOT_RECRUITING · Updated 2026-09-11 |
| 2023-508607-20-00 | A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects with Metastatic Hormonesensitive Prostate Cancer (mHSPC) Status: UNKNOWN · Updated 2026-09-09 |
| NCT07801898 | Neoadjuvant Endocrine Therapy Combined With Chemotherapy in ER-positive, HER2-negative Stage I-III Breast Cancer Status: NOT_YET_RECRUITING · Updated 2026-09-03 |
| NCT04557059 | A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer Status: ACTIVE_NOT_RECRUITING · Updated 2026-08-28 |
| NCT07793162 | A Phase Ia Trial Comparing the Pharmacokinetics/Pharmacodynamics, Safety, and Preliminary Efficacy of HHK001 and Enantone in Patients With Endometriosis Status: NOT_YET_RECRUITING · Updated 2026-08-28 |
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