Drug · FAERS side-effect profile with label screen
Elacestrant side effects: what 7,117 FDA adverse event reports show
Drug class
Estrogen Receptor Antagonist
FDA label (Established Pharmacologic Class)
Brand names
Orserdu
openFDA label
Who reports
7,117 reports · 33% serious · 548 with death outcome · 99% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)‑negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test , with disease progression following at least one line of endocrine therapy.
FDA label, Indications and Usage
What it is
Elacestrant hydrochloride is the salt form of elacestrant, an estrogen receptor antagonist, that has the chemical name: (6R)-6-(2-(N-(4-(2-(ethylamino)ethyl)benzyl)-N-ethylamino)-4-methoxyphenyl)-5,6,7,8-tetrahydronaphthalen-2-ol dihydrochloride.
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 7Labeled (related wording) 3Reporting / coding artifact 8Lab value / disease marker 1Not in label — unassessed 21
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.
- 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. 115 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 |
|---|---|---|---|---|---|---|
| Product use complaint | 110 | 21.1 17.5–25.4ROR 21.4 · χ² 2,067 / p <1e-300 | 20.8 EB05 17.8 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=57 · 84% consumer | no trial data cached |
| Hospice care | 69 | 20.8 16.4–26.3ROR 21.0 · χ² 1,271 / p 1e-278 | 20.5 EB05 16.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 21.0 | no trial data cached |
| Disease progression | 780 | 19.6 18.4–21.0ROR 21.9 · χ² 13,744 / p <1e-300 | 19.5 EB05 18.4 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 16.4 | no trial data cached |
| Product dose omission in error | 96 | 10.6 8.7–12.9ROR 10.7 · χ² 820 / p 1e-180 | 10.4 EB05 8.7 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 16.5 · 100% consumer | no trial data cached |
| Metastases to bone | 58 | 10.5 8.1–13.5ROR 10.6 · χ² 487 / p 4e-108 | 10.1 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 · 72% consumer | no trial data cached |
| Metastases to liver | 58 | 9.8 7.6–12.6ROR 9.8 · χ² 447 / p 2e-99 | 9.4 EB05 7.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 | no trial data cached |
| Bone pain | 163 | 8.2 7.1–9.6ROR 8.4 · χ² 1,025 / p 3e-225 | 8.1 EB05 7.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · 96% consumer | no trial data cached |
| Blood cholesterol increased | 129 | 8.2 6.9–9.7ROR 8.3 · χ² 804 / p 4e-177 | 8.0 EB05 6.9 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 · 95% consumer | no trial data cached |
| Hot flush (hot flashes) | 194 | 7.6 6.6–8.7ROR 7.8 · χ² 1,106 / p 7e-243 | 7.5 EB05 6.6 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 · 96% consumer | no trial data cached |
| Musculoskeletal chest pain | 38 | 7.2 5.3–9.9ROR 7.3 · χ² 198 / p 3e-45 | 6.7 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 97% consumer | no trial data cached |
| Dyspepsia (indigestion) | 236 | 7.1 6.3–8.1ROR 7.3 · χ² 1,234 / p 1e-270 | 7.0 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · 93% consumer | no trial data cached |
| Neoplasm progression | 79 | 6.6 5.3–8.3ROR 6.7 · χ² 373 / p 2e-83 | 6.4 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · 92% consumer | no trial data cached |
| Nausea | 1,501 | 5.6 5.4–5.9ROR 6.8 · χ² 5,899 / p <1e-300 | 5.6 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 90% consumer | no trial data cached |
| Constipation | 407 | 5.5 5.0–6.1ROR 5.8 · χ² 1,526 / p <1e-300 | 5.5 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 · 96% consumer | no trial data cached |
| Metastases to lung | 19 | 4.9 3.1–7.6ROR 4.9 · χ² 54 / p 9e-14 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Oesophagitis | 18 | 4.9 3.1–7.7ROR 4.9 · χ² 51 / p 4e-13 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Malignant neoplasm progression | 167 | 4.8 4.2–5.6ROR 4.9 · χ² 506 / p 2e-112 | 4.8 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 · 71% consumer | no trial data cached |
| Illness | 163 | 4.8 4.1–5.6ROR 4.9 · χ² 486 / p 6e-108 | 4.7 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 · 94% consumer | no trial data cached |
| Decreased appetite (loss of appetite) | 373 | 4.8 4.3–5.2ROR 5.0 · χ² 1,111 / p 5e-244 | 4.7 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 93% consumer | no trial data cached |
| Breast pain | 17 | 4.7 2.9–7.6ROR 4.7 · χ² 46 / p 6e-12 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious n=5 | no trial data cached |
| Gastroenteritis viral | 27 | 4.4 3.0–6.4ROR 4.4 · χ² 67 / p 1e-16 | 4.1 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 100% consumer | no trial data cached |
| Metastases to central nervous system | 19 | 4.4 2.8–6.9ROR 4.4 · χ² 46 / p 6e-12 | 4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Vomiting | 685 | 4.3 4.0–4.6ROR 4.7 · χ² 1,775 / p <1e-300 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · 92% consumer | no trial data cached |
| Feeding disorder | 29 | 4.3 3.0–6.2ROR 4.3 · χ² 70 / p 3e-17 | 4.0 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 90% consumer | no trial data cached |
| Fatigue (tiredness) | 1,122 | 4.3 4.0–4.5ROR 4.9 · χ² 2,899 / p <1e-300 | 4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · 94% consumer | no trial data cached |
| Abdominal discomfort | 235 | 4.1 3.7–4.7ROR 4.3 · χ² 562 / p 2e-124 | 4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 95% consumer | no trial data cached |
| Brain fog | 20 | 4.0 2.6–6.3ROR 4.1 · χ² 43 / p 3e-11 | 3.7 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 90% consumer | no trial data cached |
| Laboratory test abnormal | 40 | 4.0 2.9–5.5ROR 4.0 · χ² 87 / p 5e-21 | 3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 92% consumer | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 108 | 4.0 3.3–4.8ROR 4.0 · χ² 238 / p 6e-54 | 3.9 EB05 3.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 95% consumer | no trial data cached |
| Choking | 26 | 3.9 2.7–5.8ROR 4.0 · χ² 54 / p 9e-14 | 3.7 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 88% consumer | no trial data cached |
| Product dose omission issue | 377 | 3.9 3.5–4.3ROR 4.1 · χ² 822 / p 5e-181 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 · 98% consumer | no trial data cached |
| Taste disorder | 25 | 3.7 2.5–5.4ROR 3.7 · χ² 46 / p 6e-12 | 3.5 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 96% consumer | no trial data cached |
| Myalgia (muscle pain) | 212 | 3.7 3.2–4.2ROR 3.8 · χ² 414 / p 3e-92 | 3.6 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 · 94% consumer | no trial data cached |
| Blood triglycerides increased | 22 | 3.7 2.4–5.6ROR 3.7 · χ² 40 / p 1e-10 | 3.4 EB05 2.4 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.3 · 82% consumer | no trial data cached |
| Retching | 26 | 3.6 2.5–5.3ROR 3.6 · χ² 46 / p 5e-12 | 3.4 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 96% consumer | no trial data cached |
| Product availability issue | 27 | 3.6 2.4–5.2ROR 3.6 · χ² 47 / p 4e-12 | 3.4 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 · 96% consumer | no trial data cached |
| Blood sodium decreased | 21 | 3.3 2.1–5.0ROR 3.3 · χ² 31 / p 1e-8 | 3.1 EB05 2.2 · IC025 +0.9 3/3 methods agree | Lab value / disease marker | serious PRR 4.3 · 95% consumer | no trial data cached |
| Ascites | 31 | 3.1 2.2–4.4ROR 3.1 · χ² 42 / p 4e-11 | 3.0 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 84% consumer | no trial data cached |
| Flatulence (gas) | 59 | 3.1 2.4–4.0ROR 3.1 · χ² 81 / p 1e-19 | 3.0 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · 97% consumer | no trial data cached |
| Throat irritation | 46 | 3.0 2.3–4.0ROR 3.0 · χ² 61 / p 3e-15 | 3.0 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · 91% consumer | 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 |
|---|---|---|---|---|---|---|
| Nausea | 1,501 | 5.6 5.4–5.9ROR 6.8 · χ² 5,899 / p <1e-300 | 5.6 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 90% consumer | no trial data cached |
| Fatigue (tiredness) | 1,122 | 4.3 4.0–4.5ROR 4.9 · χ² 2,899 / p <1e-300 | 4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · 94% consumer | no trial data cached |
| Disease progression | 780 | 19.6 18.4–21.0ROR 21.9 · χ² 13,744 / p <1e-300 | 19.5 EB05 18.4 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 16.4 | no trial data cached |
| Vomiting | 685 | 4.3 4.0–4.6ROR 4.7 · χ² 1,775 / p <1e-300 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · 92% consumer | no trial data cached |
| Diarrhoea (diarrhea) | 563 | 2.6 2.4–2.8ROR 2.7 · χ² 560 / p 4e-124 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 · 93% consumer | no trial data cached |
| Death | 516 | 1.8 1.6–1.9ROR 1.8 · χ² 178 / p 7e-41 | 1.8 EB05 1.6 · IC025 +0.7 | Outcome field, not a reaction | serious PRR 3.1 | no trial data cached |
| Constipation | 407 | 5.5 5.0–6.1ROR 5.8 · χ² 1,526 / p <1e-300 | 5.5 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 · 96% consumer | no trial data cached |
| Product dose omission issue | 377 | 3.9 3.5–4.3ROR 4.1 · χ² 822 / p 5e-181 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 · 98% consumer | no trial data cached |
| Pain | 373 | 1.8 1.6–2.0ROR 1.8 · χ² 132 / p 7e-31 | 1.8 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 · 96% consumer | no trial data cached |
| Decreased appetite (loss of appetite) | 373 | 4.8 4.3–5.2ROR 5.0 · χ² 1,111 / p 5e-244 | 4.7 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 93% consumer | no trial data cached |
| Arthralgia (joint pain) | 336 | 2.4 2.2–2.7ROR 2.5 · χ² 276 / p 3e-62 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.5 · 96% consumer | no trial data cached |
| Asthenia (weakness) | 245 | 1.9 1.7–2.2ROR 2.0 · χ² 109 / p 8e-26 | 1.9 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.9 · 93% consumer | no trial data cached |
| Dyspepsia (indigestion) | 236 | 7.1 6.3–8.1ROR 7.3 · χ² 1,234 / p 1e-270 | 7.0 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · 93% consumer | no trial data cached |
| Abdominal discomfort | 235 | 4.1 3.7–4.7ROR 4.3 · χ² 562 / p 2e-124 | 4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 95% consumer | no trial data cached |
| Myalgia (muscle pain) | 212 | 3.7 3.2–4.2ROR 3.8 · χ² 414 / p 3e-92 | 3.6 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 · 94% 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.
- Hospice care — n=69, PRR 20.8
- Metastases to bone — n=58, PRR 10.5
- Metastases to liver — n=58, PRR 9.8
- Bone pain — n=163, PRR 8.2
- Musculoskeletal chest pain — n=38, PRR 7.2
- Neoplasm progression — n=79, PRR 6.6
- Gastroenteritis viral — n=27, PRR 4.4
- Feeding disorder — n=29, PRR 4.3
- Abdominal discomfort — n=235, PRR 4.1
- Brain fog — n=20, PRR 4.0
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 Elacestrant?
In FDA FAERS, the most frequently co-reported reaction terms for Elacestrant are nausea, fatigue, vomiting, diarrhoea, constipation, pain. 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 Elacestrant have an FDA boxed warning?
No. The FDA label retrieved for Elacestrant has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Elacestrant 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 aa66ae5c-2bd2-4444-8178-b55651e054ef, effective 20260624; matched on
openfda.generic_name.exact:"ELACESTRANT") - 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, 155 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.