Drug · FAERS side-effect profile with label screen
Elagolix side effects: what 3,723 FDA adverse event reports show
Drug class
Gonadotropin-releasing hormone (gnrh) receptor antagonist
FDA label, Indications wording
Brand names
Orilissa
openFDA label
Who reports
3,723 reports · 35% serious · 6 with death outcome · 100% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ORILISSA is indicated for the management of moderate to severe pain associated with endometriosis. Limitation s of Use: Limit the duration of use based on the dose and coexisting condition (see Table 1 ) .
FDA label, Indications and Usage
What it is
ORILISSA (elagolix) tablets for oral administration contain elagolix sodium, the sodium salt of the active moiety elagolix. Elagolix sodium 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 9Labeled (related wording) 6Likely indication confounding 1Reporting / coding artifact 5Lab value / disease marker 1Not 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. 43 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 |
|---|---|---|---|---|---|---|
| Dysmenorrhoea | 97 | 42.1 34.6–51.3ROR 43.2 · χ² 3,823 / p <1e-300 | 41.5 EB05 35.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=41 · 86% consumer | no trial data cached |
| Hot flush (hot flashes) | 471 | 35.4 32.5–38.5ROR 40.4 · χ² 15,671 / p <1e-300 | 35.1 EB05 32.6 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 29.4 · 86% consumer | no trial data cached |
| Amenorrhoea (missed periods) | 99 | 33.6 27.6–40.8ROR 34.5 · χ² 3,082 / p <1e-300 | 33.2 EB05 28.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 36.5 · 89% consumer | no trial data cached |
| Pelvic pain | 71 | 22.1 17.5–27.8ROR 22.5 · χ² 1,402 / p <1e-300 | 21.9 EB05 17.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 26.5 · 75% consumer | no trial data cached |
| Ovarian cyst | 37 | 20.8 15.1–28.7ROR 21.0 · χ² 675 / p 4e-149 | 20.5 EB05 15.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 35.2 · 92% consumer | no trial data cached |
| Mood swings | 115 | 20.4 17.0–24.4ROR 21.0 · χ² 2,095 / p <1e-300 | 20.2 EB05 17.3 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.6 · 83% consumer | no trial data cached |
| Menorrhagia (heavy periods) | 68 | 19.3 15.2–24.4ROR 19.6 · χ² 1,158 / p 5e-254 | 19.1 EB05 15.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 31.1 | no trial data cached |
| Night sweats | 107 | 18.8 15.6–22.6ROR 19.3 · χ² 1,780 / p <1e-300 | 18.7 EB05 15.9 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.8 · 85% consumer | no trial data cached |
| Cyst | 29 | 13.2 9.2–18.9ROR 13.3 · χ² 314 / p 2e-70 | 12.7 EB05 9.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 20.3 · 83% consumer | no trial data cached |
| Surgery | 135 | 13.1 11.1–15.5ROR 13.6 · χ² 1,504 / p <1e-300 | 13.0 EB05 11.3 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 24.3 · 89% consumer | no trial data cached |
| Bone density decreased | 72 | 12.8 10.2–16.1ROR 13.1 · χ² 773 / p 2e-170 | 12.6 EB05 10.3 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 1.4 | no trial data cached |
| Mood altered | 46 | 9.5 7.2–12.7ROR 9.7 · χ² 343 / p 6e-77 | 9.1 EB05 7.0 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 148 | 9.1 7.8–10.7ROR 9.4 · χ² 1,063 / p 2e-233 | 9.0 EB05 7.8 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.8 | no trial data cached |
| Adverse drug reaction | 140 | 8.8 7.5–10.4ROR 9.1 · χ² 966 / p 2e-212 | 8.7 EB05 7.5 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 · 99% consumer | no trial data cached |
| Metrorrhagia | 27 | 8.8 6.0–12.8ROR 8.9 · χ² 179 / p 4e-41 | 8.0 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=15 · 78% consumer | no trial data cached |
| Menstruation delayed | 16 | 8.7 5.3–14.2ROR 8.7 · χ² 101 / p 4e-24 | 7.4 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Bone loss | 20 | 7.4 4.8–11.5ROR 7.5 · χ² 105 / p 7e-25 | 6.5 EB05 4.4 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Maternal exposure during pregnancy | 111 | 7.1 5.9–8.5ROR 7.3 · χ² 577 / p 9e-128 | 6.9 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 6.6 | no trial data cached |
| Crying | 45 | 7.0 5.2–9.3ROR 7.0 · χ² 224 / p 7e-51 | 6.5 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 84% consumer | no trial data cached |
| Libido decreased (lower sex drive) | 15 | 6.8 4.1–11.3ROR 6.8 · χ² 69 / p 5e-17 | 5.8 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 | no trial data cached |
| Migraine | 113 | 6.7 5.6–8.1ROR 6.9 · χ² 546 / p 5e-121 | 6.5 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · 76% consumer | no trial data cached |
| Vaginal haemorrhage | 48 | 6.4 4.8–8.4ROR 6.4 · χ² 211 / p 3e-48 | 6.0 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Emotional disorder | 32 | 5.8 4.1–8.2ROR 5.9 · χ² 123 / p 7e-29 | 5.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · 81% consumer | no trial data cached |
| Initial insomnia | 10 | 5.5 3.0–10.3ROR 5.5 · χ² 33 / p 5e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Depression | 213 | 5.3 4.6–6.0ROR 5.5 · χ² 737 / p 2e-162 | 5.2 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Menstruation irregular | 24 | 5.1 3.4–7.6ROR 5.1 · χ² 75 / p 2e-18 | 4.7 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=9 · 88% consumer | no trial data cached |
| Hepatic enzyme increased | 51 | 4.2 3.2–5.6ROR 4.3 · χ² 123 / p 8e-29 | 4.1 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.8 | no trial data cached |
| Mental disorder | 32 | 4.1 2.9–5.8ROR 4.2 · χ² 73 / p 6e-18 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 · 81% consumer | no trial data cached |
| Pain | 434 | 4.0 3.6–4.3ROR 4.4 · χ² 992 / p 5e-218 | 4.0 EB05 3.7 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.2 · 89% consumer | no trial data cached |
| Unevaluable event | 53 | 3.9 3.0–5.2ROR 4.0 · χ² 114 / p 6e-27 | 3.8 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 89% consumer | no trial data cached |
| Bone pain | 40 | 3.8 2.8–5.2ROR 3.9 · χ² 82 / p 9e-20 | 3.7 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 | no trial data cached |
| Panic attack | 22 | 3.4 2.2–5.2ROR 3.4 · χ² 35 / p 2e-9 | 3.2 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Abortion spontaneous | 23 | 3.2 2.1–4.8ROR 3.2 · χ² 33 / p 4e-9 | 3.1 EB05 2.2 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.3 | no trial data cached |
| Anxiety | 162 | 3.2 2.8–3.7ROR 3.3 · χ² 246 / p 1e-55 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · 72% consumer | no trial data cached |
| Insomnia (trouble sleeping) | 149 | 3.1 2.7–3.7ROR 3.2 · χ² 219 / p 8e-50 | 3.1 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 · 90% consumer | no trial data cached |
| Procedural pain | 15 | 3.1 1.8–5.1ROR 3.1 · χ² 19 / p 7e-6 | 2.9 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Haemorrhage | 55 | 3.0 2.3–3.9ROR 3.0 · χ² 70 / p 3e-17 | 2.9 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 | no trial data cached |
| Therapeutic product effect decreased | 23 | 2.9 1.9–4.4ROR 2.9 · χ² 27 / p 9e-8 | 2.8 EB05 2.0 · IC025 +0.8 | Reporting / coding artifact | serious PRR 2.4 · 91% consumer | no trial data cached |
| Impaired work ability | 11 | 2.9 1.6–5.2ROR 2.9 · χ² 12 / p 3e-4 | 2.7 EB05 1.6 · IC025 +0.4 | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Alopecia (hair loss) | 95 | 2.7 2.2–3.3ROR 2.8 · χ² 103 / p 2e-24 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | 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 |
|---|---|---|---|---|---|---|
| Hot flush (hot flashes) | 471 | 35.4 32.5–38.5ROR 40.4 · χ² 15,671 / p <1e-300 | 35.1 EB05 32.6 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 29.4 · 86% consumer | no trial data cached |
| Pain | 434 | 4.0 3.6–4.3ROR 4.4 · χ² 992 / p 5e-218 | 4.0 EB05 3.7 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.2 · 89% consumer | no trial data cached |
| Depression | 213 | 5.3 4.6–6.0ROR 5.5 · χ² 737 / p 2e-162 | 5.2 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Arthralgia (joint pain) | 200 | 2.7 2.4–3.1ROR 2.8 · χ² 220 / p 5e-50 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 · 70% consumer | no trial data cached |
| Anxiety | 162 | 3.2 2.8–3.7ROR 3.3 · χ² 246 / p 1e-55 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · 72% consumer | no trial data cached |
| Insomnia (trouble sleeping) | 149 | 3.1 2.7–3.7ROR 3.2 · χ² 219 / p 8e-50 | 3.1 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 · 90% consumer | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 148 | 9.1 7.8–10.7ROR 9.4 · χ² 1,063 / p 2e-233 | 9.0 EB05 7.8 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.8 | no trial data cached |
| Adverse drug reaction | 140 | 8.8 7.5–10.4ROR 9.1 · χ² 966 / p 2e-212 | 8.7 EB05 7.5 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 · 99% consumer | no trial data cached |
| Surgery | 135 | 13.1 11.1–15.5ROR 13.6 · χ² 1,504 / p <1e-300 | 13.0 EB05 11.3 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 24.3 · 89% consumer | no trial data cached |
| Mood swings | 115 | 20.4 17.0–24.4ROR 21.0 · χ² 2,095 / p <1e-300 | 20.2 EB05 17.3 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.6 · 83% consumer | no trial data cached |
| Migraine | 113 | 6.7 5.6–8.1ROR 6.9 · χ² 546 / p 5e-121 | 6.5 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · 76% consumer | no trial data cached |
| Maternal exposure during pregnancy | 111 | 7.1 5.9–8.5ROR 7.3 · χ² 577 / p 9e-128 | 6.9 EB05 5.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 6.6 | no trial data cached |
| Night sweats | 107 | 18.8 15.6–22.6ROR 19.3 · χ² 1,780 / p <1e-300 | 18.7 EB05 15.9 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.8 · 85% consumer | no trial data cached |
| Amenorrhoea (missed periods) | 99 | 33.6 27.6–40.8ROR 34.5 · χ² 3,082 / p <1e-300 | 33.2 EB05 28.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 36.5 · 89% consumer | no trial data cached |
| Dysmenorrhoea | 97 | 42.1 34.6–51.3ROR 43.2 · χ² 3,823 / p <1e-300 | 41.5 EB05 35.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=41 · 86% consumer | 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.
- Dysmenorrhoea — n=97, PRR 42.1
- Amenorrhoea — n=99, PRR 33.6
- Pelvic pain — n=71, PRR 22.1
- Ovarian cyst — n=37, PRR 20.8
- Menorrhagia — n=68, PRR 19.3
- Cyst — n=29, PRR 13.2
- Metrorrhagia — n=27, PRR 8.8
- Crying — n=45, PRR 7.0
- Migraine — n=113, PRR 6.7
- Vaginal haemorrhage — n=48, PRR 6.4
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 Elagolix?
In FDA FAERS, the most frequently co-reported reaction terms for Elagolix are hot flush, pain, depression, arthralgia, anxiety, insomnia. 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 Elagolix have an FDA boxed warning?
No. The FDA label retrieved for Elagolix has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Elagolix 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 a86757b3-09c5-fd3b-1223-244e94f50a66, effective 20251219; matched on
openfda.generic_name.exact:"ELAGOLIX") - 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, 83 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.