Drug · FAERS side-effect profile with label screen

Esterified and Methyltestosterone side effects: what 370 FDA adverse event reports show

Esterified Estrogens And Methyltestosterone · 6 reaction terms · 147 drug–reaction co-reports · data 2026-09-14

Drug class

Androgen

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

Label matched

Esterified Estrogens And Methyltestosterone (Esterified Estrogens And Methyltestosterone)

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

Who reports

370 reports · 75% serious · 12 with death outcome · 99% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Esterified Estrogens and Methyltestosterone Tablets and Esterified Estrogens and Methyltestosterone Tablets H.S. are indicated in the: Treatment of moderate to severe vasomotor symptoms associated with the menopause in those patients not improved by estrogens alone.

FDA label, Indications and Usage

What it is

DESCRIPTION Esterified Estrogens and Methyltestosterone Tablets: Each light green, oval-shaped, biconvex tablet debossed with "640" on one side and scripted "E" on other side contains: 1.25 mg of Esterified Estrogens, USP and 2.5 mg of Methyltestosterone, USP. Esterified Estrogens and Methyltestosterone Tablets H.S.

FDA label, Description section

Boxed warning

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

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 5 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 1Labeled (related wording) 2Not in label — unassessed 1

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
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.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1 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
Breast cancer female	69	145.7 117.8–180.4ROR 178.9 · calibrated p 2e-9 ✓	139.8 EB05 114.3 · IC025 +5.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 113.0	no trial data cached
Ovarian cancer	10	61.2 33.2–112.9ROR 62.9 · calibrated p 2e-5 ✓	55.1 EB05 32.0 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 47.4	no trial data cached
Breast cancer metastatic	11	58.2 32.5–104.1ROR 59.9 · calibrated p 2e-5 ✓	53.1 EB05 31.6 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 45.8	no trial data cached
Breast cancer	47	28.3 21.7–37.0ROR 32.3 · calibrated p 2e-4 ✓	28.0 EB05 21.9 · IC025 +4.0 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 22.0	no trial data cached
Pharmaceutical product complaint	6	12.9 5.8–28.6ROR 13.1 · calibrated p 0.029 ✓	9.3 EB05 3.8 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 16.1	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
Breast cancer female	69	145.7 117.8–180.4ROR 178.9 · calibrated p 2e-9 ✓	139.8 EB05 114.3 · IC025 +5.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 113.0	no trial data cached
Breast cancer	47	28.3 21.7–37.0ROR 32.3 · calibrated p 2e-4 ✓	28.0 EB05 21.9 · IC025 +4.0 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 22.0	no trial data cached
Breast cancer metastatic	11	58.2 32.5–104.1ROR 59.9 · calibrated p 2e-5 ✓	53.1 EB05 31.6 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 45.8	no trial data cached
Ovarian cancer	10	61.2 33.2–112.9ROR 62.9 · calibrated p 2e-5 ✓	55.1 EB05 32.0 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 47.4	no trial data cached
Pharmaceutical product complaint	6	12.9 5.8–28.6ROR 13.1 · calibrated p 0.029 ✓	9.3 EB05 3.8 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 16.1	no trial data cached
Sexual dysfunction	4	19.4 7.3–51.5ROR 19.6 · calibrated p 0.012 ✓	13.4 EB05 3.7 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 22.3	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Conjugated Estrogens And Medroxyprogesterone Acetate ↔ Breast Cancer.

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 Esterified and Methyltestosterone?

In FDA FAERS, the most frequently co-reported reaction terms for Esterified and Methyltestosterone are breast cancer female, breast cancer, breast cancer metastatic, ovarian cancer, pharmaceutical product complaint, sexual dysfunction. 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 Esterified and Methyltestosterone have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

Do FAERS signals prove that Esterified and Methyltestosterone 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 2157d248-f6f5-4cb4-806d-d2e8eec6a8db, effective 20260422; matched on openfda.generic_name.exact:"ESTERIFIED ESTROGENS AND METHYLTESTOSTERONE")
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, 6 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 2026-10-25. 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.