Drug · FAERS side-effect profile with label screen

Conjugated Estrogens and Bazedoxifene side effects: what 932 FDA adverse event reports show

Conjugated Estrogens/Bazedoxifene · 12 reaction terms · 210 drug–reaction co-reports · data 2026-09-14

Drug class

Estrogen

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Conjugated Estrogens (Premarin Vaginal)

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

Who reports

932 reports · 22% serious · 2 with death outcome · 100% female

openFDA FAERS counts, all years, deduplication not applied

Used for

PREMARIN (conjugated estrogens) vaginal cream is a mixture of estrogens indicated for: • Treatment of Atrophic Vaginitis and Kraurosis Vulvae ( 1.1 ) • Treatment of Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy, due to Menopau.

FDA label, Indications and Usage

What it is

Each gram of PREMARIN (CE) vaginal cream contains 0.625 mg CE, USP in a nonliquefying base containing cetyl esters wax, cetyl alcohol, white wax, glyceryl monostearate, propylene glycol monostearate, methyl stearate, benzyl alcohol, sodium lauryl sulfate, glycerin, and mineral oil.

FDA label, Description section

Boxed warning

ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens.

FDA 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 10 strongest signals

Labeled adverse reaction 4Labeled (related wording) 2Reporting / coding artifact 2Not in label — unassessed 2

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.
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
Hot flush (hot flashes)	78	23.3 18.8–28.8ROR 25.3 · χ² 1,647 / p <1e-300	23.2 EB05 19.2 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.9	no trial data cached
Breast pain	7	14.8 7.1–30.9ROR 14.9 · χ² 77 / p 1e-18	11.9 EB05 4.9 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious n=1	no trial data cached
Drug effect incomplete	22	13.4 8.9–20.3ROR 13.7 · χ² 241 / p 1e-54	12.8 EB05 8.5 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 6.3	no trial data cached
Metrorrhagia	10	13.0 7.0–24.1ROR 13.1 · χ² 99 / p 1e-23	11.1 EB05 5.5 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=2	no trial data cached
Therapeutic response unexpected	25	12.5 8.5–18.4ROR 12.8 · χ² 254 / p 2e-57	11.9 EB05 8.1 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 10.2 · 84% consumer	no trial data cached
Vaginal haemorrhage	16	8.5 5.2–13.7ROR 8.6 · χ² 98 / p 2e-23	7.2 EB05 4.6 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 38.0	no trial data cached
Mood altered	10	8.3 4.5–15.3ROR 8.4 · χ² 57 / p 2e-14	6.5 EB05 3.6 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Irritability	21	7.8 5.1–12.0ROR 8.0 · χ² 119 / p 5e-28	6.9 EB05 4.7 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.7 · 71% consumer	no trial data cached
Mood swings	8	5.6 2.8–11.3ROR 5.7 · χ² 26 / p 2e-7	4.4 EB05 2.4 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Drug effective for unapproved indication	7	5.4 2.6–11.3ROR 5.4 · χ² 21 / p 2e-6	4.1 EB05 2.2 · IC025 +0.8 3/3 methods agree	Labeled (related wording) related wording	–	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)	78	23.3 18.8–28.8ROR 25.3 · χ² 1,647 / p <1e-300	23.2 EB05 19.2 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.9	no trial data cached
Therapeutic response unexpected	25	12.5 8.5–18.4ROR 12.8 · χ² 254 / p 2e-57	11.9 EB05 8.1 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 10.2 · 84% consumer	no trial data cached
Drug effect incomplete	22	13.4 8.9–20.3ROR 13.7 · χ² 241 / p 1e-54	12.8 EB05 8.5 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 6.3	no trial data cached
Irritability	21	7.8 5.1–12.0ROR 8.0 · χ² 119 / p 5e-28	6.9 EB05 4.7 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.7 · 71% consumer	no trial data cached
Vaginal haemorrhage	16	8.5 5.2–13.7ROR 8.6 · χ² 98 / p 2e-23	7.2 EB05 4.6 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 38.0	no trial data cached
Mood altered	10	8.3 4.5–15.3ROR 8.4 · χ² 57 / p 2e-14	6.5 EB05 3.6 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Metrorrhagia	10	13.0 7.0–24.1ROR 13.1 · χ² 99 / p 1e-23	11.1 EB05 5.5 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=2	no trial data cached
Mood swings	8	5.6 2.8–11.3ROR 5.7 · χ² 26 / p 2e-7	4.4 EB05 2.4 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Drug effective for unapproved indication	7	5.4 2.6–11.3ROR 5.4 · χ² 21 / p 2e-6	4.1 EB05 2.2 · IC025 +0.8 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Breast pain	7	14.8 7.1–30.9ROR 14.9 · χ² 77 / p 1e-18	11.9 EB05 4.9 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious n=1	no trial data cached
Menorrhagia (heavy periods)	3	3.4 1.1–10.5ROR 3.4 · χ² 3 / p 0.043	2.5 EB05 1.0 · IC025 -0.7 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 6.7	no trial data cached
Dysmenorrhoea	3	5.2 1.7–16.0ROR 5.2 · χ² 6 / p 0.006	3.3 EB05 1.3 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious n=1	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.

Hot flush — n=78, PRR 23.3

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 Conjugated Estrogens and Bazedoxifene?

In FDA FAERS, the most frequently co-reported reaction terms for Conjugated Estrogens and Bazedoxifene are hot flush, irritability, vaginal haemorrhage, mood altered, metrorrhagia, mood swings. 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 Conjugated Estrogens and Bazedoxifene have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens.

Do FAERS signals prove that Conjugated Estrogens and Bazedoxifene 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 96609623-528e-4aba-cabe-7254aed816d5, effective 20250530; matched on openfda.generic_name.exact:"CONJUGATED ESTROGENS")
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, 12 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.