Drug · FAERS side-effect profile with label screen
Estrogen side effects: what 2,912 FDA adverse event reports show
Brand names
Estrogen 1517
openFDA label
Who reports
2,912 reports · 48% serious · 80 with death outcome · 98% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For the temporary relief of occasional headache, diarrhea, cramps, coughing, sneezing, or runny nose due to sensitivity to phenolic compounds found in foods or other products.
FDA label, Indications and Usage
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
Reporting / coding artifact 4No label text to screen 36
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 213 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 |
|---|---|---|---|---|---|---|
| Madarosis | 21 | 12.9 8.4–19.8ROR 13.0 · χ² 219 / p 7e-50 | 12.2 EB05 8.0 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Hair texture abnormal | 23 | 12.3 8.2–18.5ROR 12.4 · χ² 227 / p 1e-51 | 11.6 EB05 7.7 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 | no trial data cached |
| Breast cancer female | 37 | 9.9 7.2–13.7ROR 10.0 · χ² 288 / p 8e-65 | 9.4 EB05 6.9 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.0 | no trial data cached |
| Hair colour changes | 16 | 9.2 5.6–14.9ROR 9.2 · χ² 108 / p 1e-25 | 7.9 EB05 4.9 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Osteopenia | 19 | 9.0 5.7–14.1ROR 9.0 · χ² 127 / p 1e-29 | 7.9 EB05 5.1 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.0 | no trial data cached |
| Intervertebral disc degeneration | 11 | 8.5 4.7–15.4ROR 8.5 · χ² 66 / p 3e-16 | 6.8 EB05 3.9 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 | no trial data cached |
| Bone disorder | 21 | 8.2 5.4–12.6ROR 8.3 · χ² 126 / p 1e-29 | 7.3 EB05 4.9 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.2 | no trial data cached |
| Vitamin d deficiency | 11 | 8.1 4.5–14.7ROR 8.2 · χ² 62 / p 2e-15 | 6.5 EB05 3.7 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.7 | no trial data cached |
| Vaginal discharge | 10 | 7.2 3.9–13.3ROR 7.2 · χ² 47 / p 3e-12 | 5.6 EB05 3.2 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=6 | no trial data cached |
| Wrist fracture | 11 | 6.6 3.7–11.9ROR 6.6 · χ² 47 / p 4e-12 | 5.3 EB05 3.2 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.3 | no trial data cached |
| Hot flush (hot flashes) | 69 | 6.6 5.2–8.3ROR 6.7 · χ² 323 / p 2e-72 | 6.3 EB05 5.2 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 | no trial data cached |
| Gastrointestinal pain | 10 | 6.6 3.5–12.2ROR 6.6 · χ² 42 / p 5e-11 | 5.2 EB05 3.0 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.0 | no trial data cached |
| Multiple fractures | 15 | 6.5 3.9–10.8ROR 6.5 · χ² 65 / p 4e-16 | 5.5 EB05 3.5 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Osteoporosis | 35 | 6.1 4.4–8.5ROR 6.2 · χ² 145 / p 1e-33 | 5.7 EB05 4.3 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 | no trial data cached |
| Foot fracture | 16 | 6.1 3.7–9.9ROR 6.1 · χ² 63 / p 1e-15 | 5.2 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.1 | no trial data cached |
| Wrong technique in drug usage process | 31 | 6.1 4.3–8.6ROR 6.1 · χ² 126 / p 1e-29 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 73% consumer | no trial data cached |
| Ankle fracture | 13 | 6.0 3.5–10.4ROR 6.1 · χ² 50 / p 9e-13 | 5.1 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 | no trial data cached |
| Pharyngeal oedema | 13 | 6.0 3.5–10.3ROR 6.0 · χ² 49 / p 1e-12 | 5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 | no trial data cached |
| Feeling jittery | 15 | 5.7 3.4–9.4ROR 5.7 · χ² 53 / p 2e-13 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=5 | no trial data cached |
| Fibromyalgia | 19 | 5.6 3.6–8.8ROR 5.7 · χ² 68 / p 9e-17 | 5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 | no trial data cached |
| Tendonitis | 12 | 5.6 3.2–9.8ROR 5.6 · χ² 40 / p 1e-10 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.4 | no trial data cached |
| Restless legs syndrome | 14 | 5.5 3.3–9.3ROR 5.6 · χ² 48 / p 3e-12 | 4.7 EB05 3.0 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.4 | no trial data cached |
| Cystitis | 24 | 5.4 3.6–8.1ROR 5.4 · χ² 82 / p 7e-20 | 4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Pelvic pain | 13 | 5.1 3.0–8.9ROR 5.2 · χ² 39 / p 2e-10 | 4.4 EB05 2.8 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.4 | no trial data cached |
| Paralysis | 10 | 5.0 2.7–9.3ROR 5.0 · χ² 28 / p 5e-8 | 4.2 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | no trial data cached |
| Hyperthyroidism | 10 | 5.0 2.7–9.2ROR 5.0 · χ² 28 / p 6e-8 | 4.1 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Dry eye | 32 | 4.8 3.4–6.7ROR 4.8 · χ² 91 / p 6e-22 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 · 79% consumer | no trial data cached |
| Poor quality sleep | 14 | 4.7 2.8–7.9ROR 4.7 · χ² 37 / p 5e-10 | 4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | no trial data cached |
| Economic problem | 10 | 4.7 2.5–8.7ROR 4.7 · χ² 25 / p 2e-7 | 3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 | no trial data cached |
| Thyroid disorder | 10 | 4.7 2.5–8.7ROR 4.7 · χ² 25 / p 2e-7 | 3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
| Scar | 11 | 4.6 2.6–8.3ROR 4.6 · χ² 28 / p 7e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 | no trial data cached |
| Musculoskeletal discomfort | 11 | 4.6 2.6–8.3ROR 4.6 · χ² 28 / p 8e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 | no trial data cached |
| Osteoarthritis | 27 | 4.6 3.1–6.7ROR 4.6 · χ² 72 / p 1e-17 | 4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | no trial data cached |
| Eructation (belching) | 12 | 4.5 2.6–8.0ROR 4.6 · χ² 30 / p 2e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=5 | no trial data cached |
| Crying | 23 | 4.5 3.0–6.8ROR 4.6 · χ² 60 / p 5e-15 | 4.2 EB05 2.9 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | no trial data cached |
| Rash papular | 14 | 4.5 2.7–7.6ROR 4.5 · χ² 35 / p 2e-9 | 4.0 EB05 2.5 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 | no trial data cached |
| Gallbladder disorder | 11 | 4.4 2.5–8.0ROR 4.4 · χ² 26 / p 2e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Intentional drug misuse | 13 | 4.4 2.6–7.6ROR 4.4 · χ² 31 / p 1e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 | no trial data cached |
| Arthritis | 48 | 4.4 3.3–5.8ROR 4.4 · χ² 123 / p 9e-29 | 4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Tinnitus (ringing in the ears) | 28 | 4.4 3.0–6.3ROR 4.4 · χ² 70 / p 3e-17 | 4.1 EB05 3.0 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.9 | 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 |
|---|---|---|---|---|---|---|
| Feeling abnormal | 117 | 3.5 2.9–4.2ROR 3.6 · χ² 209 / p 1e-47 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 · 71% consumer | no trial data cached |
| Alopecia (hair loss) | 106 | 3.9 3.2–4.7ROR 4.0 · χ² 226 / p 3e-51 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 · 86% consumer | no trial data cached |
| Weight increased (weight gain) | 97 | 3.1 2.6–3.8ROR 3.2 · χ² 140 / p 1e-32 | 3.1 EB05 2.6 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.6 · 77% consumer | no trial data cached |
| Injection site pain (pain where injected) | 77 | 1.8 1.5–2.3ROR 1.8 · χ² 28 / p 5e-8 | 1.8 EB05 1.5 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 3.5 | no trial data cached |
| Hot flush (hot flashes) | 69 | 6.6 5.2–8.3ROR 6.7 · χ² 323 / p 2e-72 | 6.3 EB05 5.2 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 | no trial data cached |
| Hyperhidrosis (excessive sweating) | 68 | 3.8 3.0–4.8ROR 3.9 · χ² 138 / p 3e-32 | 3.7 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 · 72% consumer | no trial data cached |
| Product quality issue | 59 | 3.2 2.4–4.1ROR 3.2 · χ² 85 / p 1e-20 | 3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 · 76% consumer | no trial data cached |
| Incorrect dose administered | 57 | 1.8 1.4–2.4ROR 1.8 · χ² 21 / p 3e-6 | 1.8 EB05 1.5 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.3 · 79% consumer | no trial data cached |
| Palpitations (pounding heartbeat) | 56 | 3.4 2.7–4.5ROR 3.5 · χ² 95 / p 8e-23 | 3.4 EB05 2.7 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 · 78% consumer | no trial data cached |
| Breast cancer | 54 | 4.1 3.2–5.4ROR 4.2 · χ² 126 / p 2e-29 | 4.0 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | no trial data cached |
| Migraine | 51 | 3.9 2.9–5.1ROR 3.9 · χ² 106 / p 3e-25 | 3.8 EB05 3.0 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 · 77% consumer | no trial data cached |
| Drug dose omission | 48 | 2.1 1.6–2.7ROR 2.1 · χ² 25 / p 2e-7 | 2.0 EB05 1.6 · IC025 +0.5 | Reporting / coding artifact | serious PRR 3.3 · 78% consumer | no trial data cached |
| Arthritis | 48 | 4.4 3.3–5.8ROR 4.4 · χ² 123 / p 9e-29 | 4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Wrong technique in product usage process | 43 | 1.5 1.1–2.1ROR 1.5 · χ² 8 / p 0.003 | 1.5 EB05 1.2 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Flushing | 42 | 3.0 2.2–4.0ROR 3.0 · χ² 53 / p 2e-13 | 2.9 EB05 2.2 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.1 · 77% consumer | 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.
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 Estrogen?
In FDA FAERS, the most frequently co-reported reaction terms for Estrogen are feeling abnormal, alopecia, weight increased, injection site pain, hot flush, hyperhidrosis. 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 Estrogen have an FDA boxed warning?
No. The FDA label retrieved for Estrogen has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Estrogen 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 cc44798b-c78f-456e-9b25-9f52eb26ef78, effective 20260108; matched on
openfda.generic_name.exact:"ESTROGEN") - 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, 253 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.