Drug · FAERS side-effect profile with label screen

Elagolix and Estradiol and Norethisterone side effects: what 600 FDA adverse event reports show

Elagolix And Estradiol And Norethisterone · 13 reaction terms · 250 drug–reaction co-reports · data 2026-09-14

Drug class

Gonadotropin-releasing hormone (gnrh) receptor antagonist

FDA label, Indications wording of the closest related product

Label matched

Elagolix (Orilissa)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

600 reports · 32% serious · 1 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 11 strongest signals

Labeled adverse reaction 2Reporting / coding artifact 1Not in label — unassessed 8

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.
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.
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. 2 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Dysmenorrhoea	17	45.5 28.5–72.7ROR 46.8 · χ² 695 / p 2e-153	43.4 EB05 28.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Amenorrhoea (missed periods)	19	39.8 25.6–62.0ROR 41.1 · χ² 681 / p 3e-150	38.4 EB05 26.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.6	no trial data cached
Menstruation irregular	21	27.7 18.2–42.1ROR 28.6 · χ² 514 / p 5e-114	27.1 EB05 18.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=4 · 90% consumer	no trial data cached
Vaginal discharge	6	20.9 9.4–46.3ROR 21.1 · χ² 95 / p 1e-22	17.8 EB05 6.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Vaginal haemorrhage	25	20.5 14.0–30.1ROR 21.4 · χ² 446 / p 3e-99	20.2 EB05 14.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.5	no trial data cached
Surgery	29	17.5 12.3–25.0ROR 18.3 · χ² 436 / p 5e-97	17.2 EB05 12.5 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 36.1 · 86% consumer	no trial data cached
Hot flush (hot flashes)	32	14.8 10.6–20.8ROR 15.6 · χ² 401 / p 2e-89	14.5 EB05 10.6 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.5 · 84% consumer	no trial data cached
Menorrhagia (heavy periods)	8	14.0 7.1–27.9ROR 14.2 · χ² 84 / p 2e-20	11.5 EB05 5.2 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.1	no trial data cached
Alopecia (hair loss)	71	12.6 10.1–15.7ROR 14.2 · χ² 754 / p 2e-166	12.4 EB05 10.1 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.4 · 87% consumer	no trial data cached
Mood altered	9	11.6 6.1–22.1ROR 11.7 · χ² 77 / p 1e-18	9.2 EB05 4.6 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.4	no trial data cached
Pelvic pain	6	11.5 5.2–25.6ROR 11.6 · χ² 48 / p 3e-12	8.0 EB05 3.4 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	–	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
Alopecia (hair loss)	71	12.6 10.1–15.7ROR 14.2 · χ² 754 / p 2e-166	12.4 EB05 10.1 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.4 · 87% consumer	no trial data cached
Hot flush (hot flashes)	32	14.8 10.6–20.8ROR 15.6 · χ² 401 / p 2e-89	14.5 EB05 10.6 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.5 · 84% consumer	no trial data cached
Surgery	29	17.5 12.3–25.0ROR 18.3 · χ² 436 / p 5e-97	17.2 EB05 12.5 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 36.1 · 86% consumer	no trial data cached
Vaginal haemorrhage	25	20.5 14.0–30.1ROR 21.4 · χ² 446 / p 3e-99	20.2 EB05 14.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.5	no trial data cached
Menstruation irregular	21	27.7 18.2–42.1ROR 28.6 · χ² 514 / p 5e-114	27.1 EB05 18.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=4 · 90% consumer	no trial data cached
Amenorrhoea (missed periods)	19	39.8 25.6–62.0ROR 41.1 · χ² 681 / p 3e-150	38.4 EB05 26.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.6	no trial data cached
Dysmenorrhoea	17	45.5 28.5–72.7ROR 46.8 · χ² 695 / p 2e-153	43.4 EB05 28.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Mood altered	9	11.6 6.1–22.1ROR 11.7 · χ² 77 / p 1e-18	9.2 EB05 4.6 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.4	no trial data cached
Menorrhagia (heavy periods)	8	14.0 7.1–27.9ROR 14.2 · χ² 84 / p 2e-20	11.5 EB05 5.2 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.1	no trial data cached
Pelvic pain	6	11.5 5.2–25.6ROR 11.6 · χ² 48 / p 3e-12	8.0 EB05 3.4 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Vaginal discharge	6	20.9 9.4–46.3ROR 21.1 · χ² 95 / p 1e-22	17.8 EB05 6.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Menstruation delayed	4	13.5 5.1–35.8ROR 13.5 · χ² 35 / p 2e-9	8.1 EB05 2.7 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Metrorrhagia	3	6.1 2.0–18.7ROR 6.1 · χ² 8 / p 0.002	3.6 EB05 1.4 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Not in label — unassessed	–	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.

Menstruation irregular — n=21, PRR 27.7
Vaginal haemorrhage — n=25, PRR 20.5
Alopecia — n=71, PRR 12.6

✓ A hand-written Bradford Hill causality assessment exists for this drug: Drospirenone/ethinyl estradiol ↔ Pulmonary embolism (venous thromboembolism).

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 and Estradiol and Norethisterone?

In FDA FAERS, the most frequently co-reported reaction terms for Elagolix and Estradiol and Norethisterone are alopecia, hot flush, vaginal haemorrhage, menstruation irregular, amenorrhoea, dysmenorrhoea. 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 and Estradiol and Norethisterone have an FDA boxed warning?

No. The FDA label retrieved for Elagolix and Estradiol and Norethisterone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Elagolix and Estradiol and Norethisterone 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, field patient.drug.openfda.generic_name.exact, 13 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.