Drug · FAERS side-effect profile with label screen
Estradiol side effects: what 44,834 FDA adverse event reports show
Who reports
44,834 reports · 49% serious · 886 with death outcome · 98% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Estradiol transdermal system is indicated for: Estradiol transdermal system is an estrogen indicated for: Treatment of moderate to severe vasomotor symptoms due to menopause (1.1) Treatment of moderate to severe symptoms of vulvar and vaginal atrophy d.
FDA label, Indications and Usage
What it is
Estradiol transdermal system, USP contains estradiol, USP in a multipolymeric adhesive. The system is designed to release estradiol, USP continuously upon application to intact skin. Five dosa.
FDA label, Description section
Boxed warning
ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, and BREAST CANCER 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 40 strongest signals
Labeled adverse reaction 6Labeled (related wording) 7Reporting / coding artifact 10Not in label — unassessed 17
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, 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). 942 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 |
|---|---|---|---|---|---|---|
| Device adhesion issue | 1,161 | 38.5 36.3–40.9ROR 39.5 · calibrated p 6e-5 ✓ | 35.6 EB05 33.9 · IC025 +5.0 3/3 methods agree vs other Estrogens: PRR 5.0 (4.7–5.3) | Reporting / coding artifact | 94% consumer | no trial arm names this drug |
| Breast cancer female | 1,709 | 31.6 30.1–33.2ROR 32.8 · calibrated p 2e-4 ✓ | 29.6 EB05 28.5 · IC025 +4.8 3/3 methods agree vs other Estrogens: PRR 0.9 (0.9–1.0) | Not in label — unassessed | serious PRR 34.9 | no trial arm names this drug |
| Product adhesion issue | 1,468 | 20.1 19.1–21.2ROR 20.8 · calibrated p 0.002 ✓ | 19.3 EB05 18.5 · IC025 +4.2 3/3 methods agree vs other Estrogens: PRR 4.9 (4.6–5.2) | Reporting / coding artifact | serious n=88 · 72% consumer | no trial arm names this drug |
| Product packaging issue | 340 | 17.7 15.9–19.7ROR 17.8 · calibrated p 0.003 ✓ | 17.1 EB05 15.6 · IC025 +3.9 3/3 methods agree vs other Estrogens: PRR 4.7 (4.2–5.4) | Reporting / coding artifact | 79% consumer | no trial arm names this drug |
| Application site rash | 331 | 11.4 10.3–12.8ROR 11.5 · calibrated p 0.020 ✓ | 11.2 EB05 10.2 · IC025 +3.3 3/3 methods agree vs other Estrogens: PRR 4.8 (4.2–5.5) | Labeled (related wording) related wording | serious n=30 · 78% consumer | no trial arm names this drug |
| Application site irritation | 244 | 9.3 8.2–10.6ROR 9.4 · calibrated p 0.041 ✓ | 9.1 EB05 8.1 · IC025 +3.0 3/3 methods agree vs other Estrogens: PRR 4.5 (3.9–5.3) | Labeled adverse reaction exact term | serious n=19 · 85% consumer | no trial arm names this drug |
| Application site pruritus | 424 | 8.9 8.1–9.8ROR 8.9 · calibrated p 0.047 ✓ | 8.7 EB05 8.0 · IC025 +3.0 3/3 methods agree vs other Estrogens: PRR 4.6 (4.1–5.2) | Labeled (related wording) related wording | serious n=37 · 83% consumer | no trial arm names this drug |
| Application site erythema | 445 | 8.0 7.3–8.8ROR 8.1 · calibrated p 0.065 | 7.8 EB05 7.2 · IC025 +2.8 3/3 methods agree vs other Estrogens: PRR 4.6 (4.1–5.1) | Labeled adverse reaction exact term | serious n=34 · 84% consumer | no trial arm names this drug |
| Meningioma | 229 | 7.4 6.5–8.4ROR 7.4 · calibrated p 0.086 | 7.2 EB05 6.4 · IC025 +2.6 3/3 methods agree vs other Estrogens: PRR 4.6 (3.9–5.4) | Not in label — unassessed | serious PRR 8.6 | no trial arm names this drug |
| Hot flush (hot flashes) | 1,171 | 7.3 6.9–7.8ROR 7.5 · calibrated p 0.080 | 7.2 EB05 6.9 · IC025 +2.8 3/3 methods agree vs other Estrogens: PRR 2.9 (2.7–3.0) | Labeled adverse reaction exact term | serious PRR 6.2 · 74% consumer | no trial arm names this drug |
| Product use complaint | 223 | 6.8 6.0–7.8ROR 6.8 · calibrated p 0.107 | 6.6 EB05 5.9 · IC025 +2.5 3/3 methods agree vs other Estrogens: PRR 4.7 (4.0–5.5) | Reporting / coding artifact | serious n=22 · 87% consumer | no trial arm names this drug |
| Product packaging quantity issue | 155 | 6.7 5.7–7.9ROR 6.7 · calibrated p 0.112 | 6.5 EB05 5.7 · IC025 +2.4 3/3 methods agree vs other Estrogens: PRR 4.7 (3.9–5.7) | Reporting / coding artifact | 84% consumer | no trial arm names this drug |
| Breast pain | 124 | 5.5 4.6–6.5ROR 5.5 · calibrated p 0.191 | 5.3 EB05 4.6 · IC025 +2.1 3/3 methods agree vs other Estrogens: PRR 2.5 (2.0–3.0) | Labeled (related wording) related wording | serious n=58 · 72% consumer | no trial arm names this drug |
| Night sweats | 366 | 5.4 4.8–5.9ROR 5.4 · calibrated p 0.197 | 5.3 EB05 4.8 · IC025 +2.2 3/3 methods agree vs other Estrogens: PRR 3.1 (2.7–3.4) | Not in label — unassessed | serious PRR 4.3 · 72% consumer | no trial arm names this drug |
| Vaginal discharge | 110 | 5.2 4.3–6.2ROR 5.2 · calibrated p 0.221 | 5.0 EB05 4.3 · IC025 +2.0 3/3 methods agree vs other Estrogens: PRR 2.9 (2.3–3.6) | Labeled adverse reaction exact term | serious n=40 · 79% consumer | no trial arm names this drug |
| Dermatitis contact | 124 | 5.1 4.3–6.1ROR 5.2 · calibrated p 0.222 | 5.0 EB05 4.3 · IC025 +2.0 3/3 methods agree vs other Estrogens: PRR 3.9 (3.2–4.8) | Not in label — unassessed | serious n=51 · 76% consumer | no trial arm names this drug |
| Intervertebral disc degeneration | 96 | 4.9 4.0–5.9ROR 4.9 · calibrated p 0.254 | 4.7 EB05 4.0 · IC025 +1.9 3/3 methods agree vs other Estrogens: PRR 2.2 (1.7–2.7) | Not in label — unassessed | serious PRR 6.0 | no trial arm names this drug |
| Product physical issue | 204 | 4.8 4.2–5.5ROR 4.8 · calibrated p 0.255 | 4.7 EB05 4.2 · IC025 +2.0 3/3 methods agree vs other Estrogens: PRR 4.2 (3.5–4.9) | Reporting / coding artifact | 80% consumer | no trial arm names this drug |
| Circumstance or information capable of leading to medication error | 342 | 4.8 4.3–5.3ROR 4.8 · calibrated p 0.255 | 4.7 EB05 4.3 · IC025 +2.1 3/3 methods agree vs other Estrogens: PRR 4.7 (4.1–5.3) | Labeled (related wording) related wording | 94% consumer | no trial arm names this drug |
| Thyroid disorder | 156 | 4.8 4.1–5.6ROR 4.8 · calibrated p 0.263 | 4.7 EB05 4.1 · IC025 +2.0 3/3 methods agree vs other Estrogens: PRR 3.0 (2.5–3.6) | Labeled (related wording) related wording | serious PRR 6.6 | no trial arm names this drug |
| Drug level increased | 163 | 4.6 4.0–5.4ROR 4.6 · calibrated p 0.280 | 4.5 EB05 4.0 · IC025 +1.9 3/3 methods agree vs other Estrogens: PRR 3.1 (2.6–3.7) | Reporting / coding artifact | serious PRR 5.9 | no trial arm names this drug |
| Skin reaction | 136 | 4.5 3.8–5.4ROR 4.6 · calibrated p 0.292 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree vs other Estrogens: PRR 4.7 (3.8–5.7) | Labeled adverse reaction exact term | serious PRR 6.9 | no trial arm names this drug |
| Application site pain | 205 | 4.4 3.8–5.0ROR 4.4 · calibrated p 0.314 | 4.3 EB05 3.8 · IC025 +1.9 3/3 methods agree vs other Estrogens: PRR 3.9 (3.3–4.6) | Labeled (related wording) related wording | serious n=25 · 86% consumer | no trial arm names this drug |
| Impaired gastric emptying | 117 | 4.3 3.6–5.2ROR 4.3 · calibrated p 0.327 | 4.2 EB05 3.6 · IC025 +1.8 3/3 methods agree vs other Estrogens: PRR 3.9 (3.2–4.8) | Not in label — unassessed | serious PRR 5.6 · 88% consumer | no trial arm names this drug |
| Sleep apnoea syndrome | 175 | 4.3 3.7–5.0ROR 4.3 · calibrated p 0.327 | 4.2 EB05 3.7 · IC025 +1.8 3/3 methods agree vs other Estrogens: PRR 3.3 (2.8–3.9) | Not in label — unassessed | serious PRR 5.5 | no trial arm names this drug |
| Poor quality product administered | 92 | 4.2 3.4–5.2ROR 4.2 · calibrated p 0.341 | 4.1 EB05 3.5 · IC025 +1.7 3/3 methods agree vs other Estrogens: PRR 3.6 (2.8–4.6) | Not in label — unassessed | 86% consumer | no trial arm names this drug |
| Brain fog | 130 | 4.2 3.5–5.0ROR 4.2 · calibrated p 0.346 | 4.1 EB05 3.5 · IC025 +1.7 3/3 methods agree vs other Estrogens: PRR 4.3 (3.5–5.3) | Not in label — unassessed | serious PRR 6.5 · 75% consumer | no trial arm names this drug |
| Hiatus hernia | 113 | 4.1 3.4–4.9ROR 4.1 · calibrated p 0.363 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree vs other Estrogens: PRR 2.7 (2.2–3.4) | Not in label — unassessed | serious PRR 5.2 | no trial arm names this drug |
| Device defective | 134 | 3.9 3.3–4.6ROR 3.9 · calibrated p 0.400 | 3.8 EB05 3.3 · IC025 +1.6 3/3 methods agree vs other Estrogens: PRR 4.7 (3.8–5.8) | Reporting / coding artifact | 85% consumer | no trial arm names this drug |
| Iron deficiency anaemia | 76 | 3.9 3.1–4.9ROR 3.9 · calibrated p 0.404 | 3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree vs other Estrogens: PRR 3.4 (2.6–4.4) | Not in label — unassessed | serious PRR 4.7 | no trial arm names this drug |
| Emphysema | 83 | 3.9 3.1–4.8ROR 3.9 · calibrated p 0.411 | 3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree vs other Estrogens: PRR 3.1 (2.4–4.0) | Not in label — unassessed | serious PRR 4.7 | no trial arm names this drug |
| Seasonal allergy | 115 | 3.8 3.2–4.6ROR 3.8 · calibrated p 0.414 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree vs other Estrogens: PRR 3.3 (2.7–4.1) | Not in label — unassessed | serious n=78 · 75% consumer | no trial arm names this drug |
| Migraine | 759 | 3.8 3.5–4.0ROR 3.8 · calibrated p 0.417 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree vs other Estrogens: PRR 3.2 (3.0–3.5) | Labeled adverse reaction exact term | serious PRR 5.1 | no trial arm names this drug |
| Fungal infection | 260 | 3.7 3.2–4.1ROR 3.7 · calibrated p 0.444 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other Estrogens: PRR 3.2 (2.8–3.7) | Not in label — unassessed | serious PRR 5.0 | no trial arm names this drug |
| Product substitution issue | 447 | 3.6 3.3–4.0ROR 3.7 · calibrated p 0.445 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other Estrogens: PRR 4.3 (3.9–4.9) | Reporting / coding artifact | serious PRR 3.2 · 86% consumer | no trial arm names this drug |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 117 | 3.6 3.0–4.4ROR 3.6 · calibrated p 0.453 | 3.6 EB05 3.1 · IC025 +1.5 3/3 methods agree vs other Estrogens: PRR 4.8 (3.8–5.9) | Not in label — unassessed | serious PRR 4.3 · 100% clinician | no trial arm names this drug |
| Respiratory depression | 94 | 3.6 2.9–4.4ROR 3.6 · calibrated p 0.464 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree vs other Estrogens: PRR 4.7 (3.7–6.0) | Labeled (related wording) related wording | serious PRR 4.3 | no trial arm names this drug |
| Candida infection (yeast infection) | 127 | 3.6 3.0–4.3ROR 3.6 · calibrated p 0.469 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree vs other Estrogens: PRR 4.2 (3.4–5.1) | Not in label — unassessed | serious PRR 5.1 | no trial arm names this drug |
| Diverticulitis | 210 | 3.6 3.1–4.1ROR 3.6 · calibrated p 0.468 | 3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree vs other Estrogens: PRR 3.4 (2.9–3.9) | Not in label — unassessed | serious PRR 4.4 | no trial arm names this drug |
| Product availability issue | 170 | 3.6 3.1–4.1ROR 3.6 · calibrated p 0.471 | 3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree vs other Estrogens: PRR 4.6 (3.8–5.5) | Reporting / coding artifact | serious PRR 2.4 · 84% consumer | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Estradiol only as a background or rescue medication (NCT01656434, NCT00996580); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.
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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 3,664 | 1.3 1.3–1.3ROR 1.3 · calibrated p 0.526 | 1.3 EB05 1.3 · IC025 +0.3 vs other Estrogens: PRR 3.2 (3.1–3.3) | Reporting / coding artifact | serious PRR 1.3 | no trial arm names this drug |
| Nausea | 2,775 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.761 | 1.6 EB05 1.6 · IC025 +0.7 vs other Estrogens: PRR 3.3 (3.2–3.5) | Labeled adverse reaction exact term | serious PRR 2.0 | no trial arm names this drug |
| Headache | 2,753 | 2.1 2.0–2.1ROR 2.1 · calibrated p 0.989 | 2.1 EB05 2.0 · IC025 +1.0 vs other Estrogens: PRR 3.3 (3.2–3.5) | Labeled adverse reaction exact term | serious PRR 2.4 | no trial arm names this drug |
| Fatigue (tiredness) | 2,749 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.767 | 1.7 EB05 1.6 · IC025 +0.7 vs other Estrogens: PRR 3.4 (3.2–3.5) | Not in label — unassessed | serious PRR 2.1 | no trial arm names this drug |
| Off label use (used outside approved label) | 2,318 | 1.2 1.2–1.3ROR 1.3 · calibrated p 0.481 | 1.2 EB05 1.2 · IC025 +0.2 vs other Estrogens: PRR 3.3 (3.1–3.4) | Reporting / coding artifact | serious PRR 1.4 | no trial arm names this drug |
| Pain | 2,006 | 1.5 1.5–1.6ROR 1.5 · calibrated p 0.673 | 1.5 EB05 1.5 · IC025 +0.5 vs other Estrogens: PRR 3.0 (2.9–3.2) | Labeled adverse reaction exact term | serious PRR 1.7 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 1,889 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.567 | 1.4 EB05 1.3 · IC025 +0.4 vs other Estrogens: PRR 3.4 (3.2–3.6) | Labeled adverse reaction exact term | serious PRR 1.6 | no trial arm names this drug |
| Breast cancer female | 1,709 | 31.6 30.1–33.2ROR 32.8 · calibrated p 2e-4 ✓ | 29.6 EB05 28.5 · IC025 +4.8 3/3 methods agree vs other Estrogens: PRR 0.9 (0.9–1.0) | Not in label — unassessed | serious PRR 34.9 | no trial arm names this drug |
| Dizziness | 1,646 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.684 | 1.5 EB05 1.5 · IC025 +0.5 vs other Estrogens: PRR 3.1 (3.0–3.3) | Labeled adverse reaction exact term | serious PRR 1.9 | no trial arm names this drug |
| Arthralgia (joint pain) | 1,586 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.841 | 1.8 EB05 1.7 · IC025 +0.8 vs other Estrogens: PRR 3.2 (3.1–3.4) | Labeled adverse reaction exact term | serious PRR 2.3 | no trial arm names this drug |
| Pruritus (itching) | 1,478 | 1.8 1.7–1.9ROR 1.9 · calibrated p 0.863 | 1.8 EB05 1.7 · IC025 +0.8 vs other Estrogens: PRR 3.6 (3.4–3.8) | Labeled adverse reaction exact term | serious PRR 1.9 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 1,474 | 1.2 1.2–1.3ROR 1.2 · calibrated p 0.457 | 1.2 EB05 1.2 · IC025 +0.2 vs other Estrogens: PRR 3.0 (2.9–3.2) | Not in label — unassessed | serious PRR 1.4 | no trial arm names this drug |
| Rash | 1,469 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.708 | 1.6 EB05 1.5 · IC025 +0.6 vs other Estrogens: PRR 3.7 (3.5–3.9) | Labeled adverse reaction exact term | serious PRR 1.8 | no trial arm names this drug |
| Product adhesion issue | 1,468 | 20.1 19.1–21.2ROR 20.8 · calibrated p 0.002 ✓ | 19.3 EB05 18.5 · IC025 +4.2 3/3 methods agree vs other Estrogens: PRR 4.9 (4.6–5.2) | Reporting / coding artifact | serious n=88 · 72% consumer | no trial arm names this drug |
| Vomiting | 1,311 | 1.3 1.2–1.4ROR 1.3 · calibrated p 0.518 | 1.3 EB05 1.2 · IC025 +0.3 vs other Estrogens: PRR 3.3 (3.1–3.5) | Labeled adverse reaction exact term | serious PRR 1.6 | no trial arm names this drug |
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.
- Breast cancer female — n=1,709, PRR 31.6
- Meningioma — n=229, PRR 7.4
- Night sweats — n=366, PRR 5.4
- Dermatitis contact — n=124, PRR 5.1
- Intervertebral disc degeneration — n=96, PRR 4.9
- Impaired gastric emptying — n=117, PRR 4.3
- Sleep apnoea syndrome — n=175, PRR 4.3
- Poor quality product administered — n=92, PRR 4.2
- Brain fog — n=130, PRR 4.2
- Hiatus hernia — n=113, PRR 4.1
✓ 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 Estradiol?
In FDA FAERS, the most frequently co-reported reaction terms for Estradiol are nausea, headache, fatigue, pain, diarrhoea, breast cancer female. 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 Estradiol have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, and BREAST CANCER 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 Estradiol 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 0500ee9b-bf4a-4432-9afe-20a7d60a6fe5, effective 20240514; matched on
openfda.generic_name.exact:"ESTRADIOL") - 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, 982 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 - ClinicalTrials.gov API v2 (query
ESTRADIOL, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.