Drug · FAERS side-effect profile with label screen
Relugolix side effects: what 23,328 FDA adverse event reports show
Drug class
Gonadotropin Releasing Hormone Receptor Antagonist
FDA label (Established Pharmacologic Class)
Brand names
Orgovyx
openFDA label
Who reports
23,328 reports · 25% serious · 1,145 with death outcome · 1% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer. ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer ( 1 ).
FDA label, Indications and Usage
What it is
Relugolix is a nonpeptide small molecule, GnRH receptor antagonist.
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 1Labeled (related wording) 3Likely indication confounding 4Reporting / coding artifact 6Lab value / disease marker 6Not in label — unassessed 20
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. 966 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 |
|---|---|---|---|---|---|---|
| Cold flash | 35 | 523.0 344.3–794.4ROR 523.8 · χ² 11,120 / p <1e-300 | 278.6 EB05 209.4 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=8 · 100% consumer | not reported in cached trials |
| Andropause | 16 | 391.8 217.5–706.0ROR 392.1 · χ² 4,052 / p <1e-300 | 205.3 EB05 134.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=5 | not reported in cached trials |
| Sexual activity decreased | 11 | 359.2 178.2–724.0ROR 359.4 · χ² 2,543 / p <1e-300 | 177.4 EB05 105.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Male genital atrophy | 13 | 127.3 71.2–227.8ROR 127.4 · χ² 1,316 / p 2e-288 | 96.1 EB05 59.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=3 | not reported in cached trials |
| Hot flush (hot flashes) | 7,432 | 97.9 95.9–99.9ROR 142.8 · χ² 643,519 / p <1e-300 | 88.2 EB05 86.5 · IC025 +6.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 75.5 · 97% consumer | NCT03085095: 338/622 (54.3%) on Relugolix |
| Prostatectomy | 56 | 96.4 73.2–127.0ROR 96.7 · χ² 4,682 / p <1e-300 | 84.6 EB05 67.6 · IC025 +5.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=52 · 95% consumer | not reported in cached trials |
| Testicular atrophy | 47 | 51.0 38.0–68.5ROR 51.1 · χ² 2,132 / p <1e-300 | 47.4 EB05 37.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=6 · 91% consumer | not reported in cached trials |
| Blood testosterone abnormal | 56 | 47.2 36.1–61.7ROR 47.3 · χ² 2,358 / p <1e-300 | 44.2 EB05 35.3 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=9 | not reported in cached trials |
| Prostatic specific antigen abnormal | 52 | 46.8 35.4–61.8ROR 46.9 · χ² 2,169 / p <1e-300 | 43.8 EB05 34.7 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=16 · 78% consumer | not reported in cached trials |
| Therapy interrupted | 3,361 | 45.8 44.3–47.3ROR 53.3 · χ² 140,381 / p <1e-300 | 43.6 EB05 42.3 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 17.0 · 92% consumer | not reported in cached trials |
| Prostatic operation | 58 | 45.7 35.1–59.5ROR 45.8 · χ² 2,371 / p <1e-300 | 43.0 EB05 34.5 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious n=53 · 95% consumer | not reported in cached trials |
| Prostatic specific antigen decreased | 17 | 41.9 25.7–68.1ROR 41.9 · χ² 609 / p 1e-134 | 38.4 EB05 25.4 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=4 | not reported in cached trials |
| Nephrostomy | 14 | 39.9 23.4–68.2ROR 40.0 · χ² 472 / p 6e-105 | 36.5 EB05 23.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Prostatic pain | 16 | 36.0 21.8–59.3ROR 36.0 · χ² 490 / p 8e-109 | 33.4 EB05 21.8 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=3 | not reported in cached trials |
| Therapeutic procedure | 52 | 35.2 26.7–46.4ROR 35.3 · χ² 1,628 / p <1e-300 | 33.5 EB05 26.5 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=23 · 98% consumer | not reported in cached trials |
| Activities of daily living decreased | 19 | 35.0 22.2–55.4ROR 35.1 · χ² 572 / p 1e-126 | 32.7 EB05 22.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Blood testosterone increased | 74 | 31.7 25.2–40.0ROR 31.8 · χ² 2,098 / p <1e-300 | 30.5 EB05 25.1 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=12 | not reported in cached trials |
| Post procedural diarrhoea | 16 | 29.0 17.6–47.8ROR 29.0 · χ² 392 / p 1e-87 | 27.3 EB05 17.8 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Central obesity | 23 | 29.0 19.1–43.9ROR 29.0 · χ² 575 / p 3e-127 | 27.5 EB05 19.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=6 · 83% consumer | not reported in cached trials |
| Prostatic specific antigen increased | 401 | 26.6 24.1–29.4ROR 27.1 · χ² 9,587 / p <1e-300 | 25.9 EB05 23.8 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious PRR 40.3 · 85% consumer | not reported in cached trials |
| Product distribution issue | 246 | 25.5 22.5–28.9ROR 25.8 · χ² 5,610 / p <1e-300 | 24.8 EB05 22.3 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=14 · 97% consumer | not reported in cached trials |
| Transurethral prostatectomy | 13 | 24.0 13.8–41.6ROR 24.0 · χ² 257 / p 4e-58 | 22.6 EB05 13.8 · IC025 +2.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | not reported in cached trials |
| Nocturia (night-time urination) | 315 | 23.9 21.4–26.7ROR 24.2 · χ² 6,700 / p <1e-300 | 23.2 EB05 21.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 · 95% consumer | NCT03085095: 36/622 (5.8%) on Relugolix |
| Incorrect dosage administered | 126 | 23.5 19.7–28.1ROR 23.7 · χ² 2,627 / p <1e-300 | 22.9 EB05 19.7 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious n=27 · 83% consumer | not reported in cached trials |
| Penile size reduced | 24 | 22.9 15.3–34.4ROR 23.0 · χ² 470 / p 2e-104 | 22.0 EB05 15.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=3 · 88% consumer | not reported in cached trials |
| Laziness | 40 | 21.4 15.6–29.2ROR 21.4 · χ² 738 / p 7e-163 | 20.7 EB05 15.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=11 · 92% consumer | not reported in cached trials |
| Muscle atrophy | 287 | 20.9 18.6–23.4ROR 21.1 · χ² 5,288 / p <1e-300 | 20.4 EB05 18.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.5 · 97% consumer | not reported in cached trials |
| Libido decreased (lower sex drive) | 254 | 18.7 16.5–21.2ROR 18.9 · χ² 4,152 / p <1e-300 | 18.3 EB05 16.5 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.2 · 95% consumer | not reported in cached trials |
| Brain fog | 277 | 17.3 15.4–19.5ROR 17.5 · χ² 4,158 / p <1e-300 | 17.0 EB05 15.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 · 96% consumer | not reported in cached trials |
| Urine flow decreased | 44 | 16.8 12.5–22.7ROR 16.9 · χ² 627 / p 9e-139 | 16.4 EB05 12.6 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=13 · 98% consumer | not reported in cached trials |
| Prostate cancer recurrent | 10 | 14.8 7.9–27.6ROR 14.8 · χ² 113 / p 9e-27 | 12.8 EB05 6.4 · IC025 +2.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | not reported in cached trials |
| Night sweats | 501 | 14.1 12.9–15.4ROR 14.4 · χ² 6,009 / p <1e-300 | 13.9 EB05 12.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · 96% consumer | not reported in cached trials |
| Testicular pain | 49 | 14.0 10.6–18.6ROR 14.1 · χ² 571 / p 1e-126 | 13.6 EB05 10.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=8 · 98% consumer | not reported in cached trials |
| Skin neoplasm excision | 12 | 13.9 7.9–24.7ROR 13.9 · χ² 129 / p 3e-30 | 12.3 EB05 6.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Pollakiuria (frequent urination) | 613 | 13.4 12.3–14.4ROR 13.7 · χ² 6,901 / p <1e-300 | 13.2 EB05 12.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · 97% consumer | NCT03085095: 37/622 (5.9%) on Relugolix |
| Positron emission tomogram abnormal | 10 | 13.1 7.0–24.5ROR 13.1 · χ² 99 / p 1e-23 | 11.0 EB05 5.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=4 | not reported in cached trials |
| Feeling of body temperature change | 82 | 12.7 10.2–15.7ROR 12.7 · χ² 857 / p 1e-188 | 12.4 EB05 10.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=19 · 96% consumer | not reported in cached trials |
| Fat tissue increased | 20 | 12.5 8.0–19.4ROR 12.5 · χ² 197 / p 5e-45 | 11.5 EB05 7.4 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious n=8 · 95% consumer | not reported in cached trials |
| Sleep deficit | 28 | 12.3 8.5–17.8ROR 12.3 · χ² 275 / p 4e-62 | 11.6 EB05 8.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=9 · 93% consumer | not reported in cached trials |
| Loss of libido | 121 | 12.2 10.2–14.6ROR 12.3 · χ² 1,217 / p 7e-267 | 11.9 EB05 10.2 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.1 · 98% consumer | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Relugolix as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (3 of 40 signal terms matched).
- NCT04756037 — Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids (N=1164, PHASE3; 25 AE terms posted; arms: Relugolix/E2/NETA)
- NCT03085095 — A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer (N=1134, PHASE3; 155 AE terms posted; arms: Relugolix; Leuprolide Acetate)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Hot flush (hot flashes) | 7,432 | 97.9 95.9–99.9ROR 142.8 · χ² 643,519 / p <1e-300 | 88.2 EB05 86.5 · IC025 +6.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 75.5 · 97% consumer | NCT03085095: 338/622 (54.3%) on Relugolix |
| Fatigue (tiredness) | 5,754 | 6.7 6.5–6.8ROR 8.5 · χ² 28,565 / p <1e-300 | 6.6 EB05 6.5 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · 95% consumer | NCT03085095: 134/622 (21.5%) on Relugolix |
| Therapy interrupted | 3,361 | 45.8 44.3–47.3ROR 53.3 · χ² 140,381 / p <1e-300 | 43.6 EB05 42.3 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 17.0 · 92% consumer | not reported in cached trials |
| Incorrect dose administered | 2,085 | 8.4 8.0–8.7ROR 9.1 · χ² 13,524 / p <1e-300 | 8.3 EB05 8.0 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 17.7 · 96% consumer | not reported in cached trials |
| Asthenia (weakness) | 1,919 | 4.6 4.4–4.8ROR 4.9 · χ² 5,442 / p <1e-300 | 4.6 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · 95% consumer | NCT03085095: 32/622 (5.1%) on Relugolix |
| Arthralgia (joint pain) | 1,551 | 3.4 3.2–3.5ROR 3.5 · χ² 2,606 / p <1e-300 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 · 94% consumer | NCT03085095: 75/622 (12.1%) on Relugolix |
| Diarrhoea (diarrhea) | 1,513 | 2.1 2.0–2.2ROR 2.2 · χ² 904 / p 6e-199 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.7 · 95% consumer | NCT03085095: 76/622 (12.2%) on Relugolix |
| Product dose omission issue | 1,316 | 4.1 3.9–4.4ROR 4.3 · χ² 3,170 / p <1e-300 | 4.1 EB05 3.9 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 8.9 · 95% consumer | not reported in cached trials |
| Dizziness | 1,292 | 2.3 2.2–2.5ROR 2.4 · χ² 995 / p 1e-218 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 94% consumer | NCT03085095: 1/308 (0.3%) on Relugolix (serious AE) |
| Constipation | 1,015 | 4.2 4.0–4.5ROR 4.4 · χ² 2,495 / p <1e-300 | 4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 95% consumer | NCT03085095: 76/622 (12.2%) on Relugolix |
| Death | 969 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.427 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 2.4 · 75% consumer | not reported in cached trials |
| Weight increased (weight gain) | 864 | 3.5 3.3–3.7ROR 3.6 · χ² 1,534 / p <1e-300 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.2 · 96% consumer | NCT03085095: 49/622 (7.9%) on Relugolix |
| Pain | 836 | 1.2 1.1–1.3ROR 1.2 · χ² 33 / p 5e-9 | 1.2 EB05 1.1 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.5 · 94% consumer | NCT04756037: 1/1,125 (0.1%) on Relugolix (serious AE) |
| Insomnia (trouble sleeping) | 835 | 2.8 2.6–3.0ROR 2.9 · χ² 978 / p 6e-215 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 · 96% consumer | NCT03085095: 43/622 (6.9%) on Relugolix |
| Myalgia (muscle pain) | 802 | 4.2 4.0–4.5ROR 4.4 · χ² 1,986 / p <1e-300 | 4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 · 95% consumer | not reported in cached trials |
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.
- Cold flash — n=35, PRR 523.0
- Testicular atrophy — n=47, PRR 51.0
- Central obesity — n=23, PRR 29.0
- Nocturia — n=315, PRR 23.9 (also seen in trial arm)
- Penile size reduced — n=24, PRR 22.9
- Laziness — n=40, PRR 21.4
- Muscle atrophy — n=287, PRR 20.9
- Brain fog — n=277, PRR 17.3
- Night sweats — n=501, PRR 14.1
- Testicular pain — n=49, PRR 14.0
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 Relugolix?
In FDA FAERS, the most frequently co-reported reaction terms for Relugolix are hot flush, fatigue, asthenia, arthralgia, diarrhoea, dizziness. 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 Relugolix have an FDA boxed warning?
No. The FDA label retrieved for Relugolix has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Relugolix 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 077a92f6-9f1b-479a-87c7-c92b5db6aa9c, effective 20251010; matched on
openfda.generic_name.exact:"RELUGOLIX") - 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, 1,006 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 - ClinicalTrials.gov API v2 (query
RELUGOLIX, results-bearing studies sorted by enrollment)
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.